,pmid,ti,ab,year,punchline_text,population,interventions,outcomes,population_mesh,interventions_mesh,outcomes_mesh,num_randomized,prob_low_rob,punchline_text,authors,journal,dois 0,32343102,OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY-GUIDED PHOTODYNAMIC THERAPY FOR ACUTE CENTRAL SEROUS CHORIORETINOPATHY.,"PURPOSE To compare the anatomic results of optical coherence tomography angiography (OCTA)-guided half-dose photodynamic therapy (PDT) versus indocyanine green angiography (ICGA)-guided PDT in eyes with acute central serous chorioretinopathy. METHODS This study is a prospective, single-center, noninferiority, double-masked, randomized, controlled clinical trial. Fifty-one eyes of 45 patients with acute central serous chorioretinopathy were recruited, and randomized to an ICGA-guided group and an OCTA-guided group. The primary outcome measures were the rates of complete subretinal fluid (SRF) resolution at 1 month and 3 months. RESULTS Forty-six eyes of 40 patients finished the follow-up and were analyzed. In the OCTA-guided group, the SRF was completely resolved in 13 (56.5%) eyes within 1 month and in 21 (91.3%) eyes within 3 months. In the ICGA-guided group, the SRF was resolved in 16 (69.6%) of the eyes within 1 month and in 22 (95.7%) of the eyes by 3 months. Optical coherence tomography angiography-guided PDT was demonstrated noninferior to ICGA-guided PDT for SRF resolution rate at 3 months (P = 0.016), but not at 1 month (P = 0.311) for acute central serous chorioretinopathy patients. Subretinal fluid did not recur in any of the eyes in the OCTA-guided group, but did recur in 2 eyes (8.7%) of the ICGA-guided group during the 3-month follow-up period. CONCLUSION Optical coherence tomography angiography-guided PDT seemed to be noninferior to ICGA-guided PDT for resolution of SRF at 3 months in eyes with acute central serous chorioretinopathy.",2021,"Optical coherence tomography angiography-guided PDT was demonstrated noninferior to ICGA-guided PDT for SRF resolution rate at 3 months (P = 0.016), but not at 1 month (P = 0.311) for acute central serous chorioretinopathy patients.","['acute central serous chorioretinopathy patients', 'eyes with acute central serous chorioretinopathy', 'Fifty-one eyes of 45 patients with acute central serous chorioretinopathy', 'Forty-six eyes of 40 patients finished the follow-up and were analyzed']","['ICGA-guided group and an OCTA-guided group', 'optical coherence tomography angiography (OCTA)-guided half-dose photodynamic therapy (PDT) versus indocyanine green angiography (ICGA)-guided PDT']","['rates of complete subretinal fluid (SRF) resolution', 'Subretinal fluid', 'SRF resolution rate', 'SRF']","[{'cui': 'C0730315', 'cui_str': 'Acute central serous chorioretinopathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0430879', 'cui_str': 'Indocyanine green angiography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1720732', 'cui_str': 'Subretinal fluid'}]",51.0,0.0527138,"Optical coherence tomography angiography-guided PDT was demonstrated noninferior to ICGA-guided PDT for SRF resolution rate at 3 months (P = 0.016), but not at 1 month (P = 0.311) for acute central serous chorioretinopathy patients.","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': ""Beijing Key Laboratory of Diagnosis and Therapy of Retinal and Choroid Diseases, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Jinfeng', 'Initials': 'J', 'LastName': 'Qu', 'Affiliation': ''}, {'ForeName': 'Mengyang', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Guosheng', 'Initials': 'G', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Piao', 'Affiliation': ''}, {'ForeName': 'Zhiqiao', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': ''}, {'ForeName': 'Yuou', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': ''}, {'ForeName': 'SriniVas', 'Initials': 'S', 'LastName': 'Sadda', 'Affiliation': ''}, {'ForeName': 'Mingwei', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': ''}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002795'] 1,32339032,SAFETY AND EFFICACY OF DDP4-INHIBITORS FOR MANAGEMENT OF HOSPITALIZED GENERAL MEDICINE AND SURGERY PATIENTS WITH TYPE 2 DIABETES.,"Background: DPP4-inhibitors (DPP4-i) have been shown to be effective for the management of inpatient diabetes. We report pooled data from three prospective studies using DPP4-i in general medicine and surgery patients with type 2 diabetes (T2D). Research Design and Methods: We combined data from three randomized studies comparing DPP4-i alone or in combination with basal insulin or basal bolus insulin regimen. Medicine (n=266) and surgery (n=319) patients admitted with a blood glucose (BG) between 140 and 400 mg/dl, treated with diet, oral agents or low-dose insulin therapy were included. Patients received DPP4-i alone (n=144), DPP4-i plus basal insulin (n=158) or basal bolus regimen (n=283). All groups received correctional doses with rapid-acting insulin for BG >140mg/dl. The primary endpoint was differences in mean daily BG between groups. Secondary endpoints included differences in hypoglycemia and hospital complications. Results: There were no differences in mean hospital daily BG among patients treated with DPP4-i alone (170±37 mg/dl), DPP4-i plus basal (172±42 mg/dl) or basal bolus (172±43 mg/dl), p=0.94; or in the percentage of BG readings within target of 70-180 mg/dl (63±32%, 60±31% and 64±28% respectively, p=0.42). There were no differences in length of stay or complications, but hypoglycemia was less common with DPP4-i alone (2%) compared to DPP4-i plus basal (9%) and basal bolus (10%), p=0.004. Conclusion: Treatment with DPP4-i alone or in combination with basal insulin is effective and results in lower incidence of hypoglycemia compared to a basal bolus insulin re gimen in general medicine and surgery patients with T2D.",2020,is effective and results in lower incidence of hypoglycemia compared to a basal bolus insulin,"['general medicine and surgery patients with T2D', 'general medicine and surgery patients with type 2 diabetes (T2D', 'n=266) and surgery (n=319) patients admitted with a blood glucose (BG) between 140 and 400 mg/dl, treated with']","['DPP4-i alone', 'correctional doses with rapid-acting insulin for BG >140mg/dl', 'DPP4-i alone or in combination with basal insulin or basal bolus insulin regimen', ': DPP4-inhibitors (DPP4-i', 'diet, oral agents or low-dose insulin therapy', 'DPP4-i plus basal insulin (n=158) or basal bolus regimen', 'DPP4-i', 'DPP4-i alone or in combination with basal insulin', 'Medicine']","['hypoglycemia and hospital complications', 'mean daily BG', 'mean hospital daily BG', 'length of stay or complications, but hypoglycemia', 'hypoglycemia']","[{'cui': 'C0086343', 'cui_str': 'General medicine'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0356365', 'cui_str': 'Short-acting insulin'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.0952002,is effective and results in lower incidence of hypoglycemia compared to a basal bolus insulin,"[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Lorenzo-González', 'Affiliation': 'From: Department of Endocrinology and Nutrition, Hospital Universitario Nuestra Señora de La Candelaria, Tenerife, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Atienza-Sánchez', 'Affiliation': 'Department of Endocrinology and Nutrition, Hospital Universitario Príncipe de Asturias, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Reyes-Umpierrez', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Priyathama', 'Initials': 'P', 'LastName': 'Vellanki', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Georgia M', 'Initials': 'GM', 'LastName': 'Davis', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Pasquel', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Saumeth', 'Initials': 'S', 'LastName': 'Cardona', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Fayfman', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Schoolf of Public Health, Emory University.'}, {'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}]",Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists,['10.4158/EP-2019-0481'] 2,32339234,Motivational Interviewing to Support Oral AntiCoagulation adherence in patients with non-valvular Atrial Fibrillation (MISOAC-AF): a randomized clinical trial.,"AIMS We aimed to assess the impact of an educational, motivational intervention on the adherence to oral anticoagulation (OAC) in patients with non-valvular atrial fibrillation (AF). METHODS AND RESULTS Hospitalized patients with non-valvular AF who received OAC were randomly assigned to usual medical care or a proactive intervention, comprising motivational interviewing, and tailored counselling on medication adherence. The primary study outcome was adherence to OAC at 1 year, which was evaluated according to proportion of days covered (PDC) by OAC regimens and was assessed through nationwide registers of prescription claims. Secondary outcomes included the rate of persistence to OAC, gaps in treatment, and clinical events. A total of 1009 patients were randomized, 500 in the intervention group and 509 in the control group. At 1-year follow-up, 77.2% (386/500) of patients in the intervention group were adherent (PDC > 80%), compared with 55% (280/509) in the control group [adjusted odds ratio (aOR) 2.84, 95% confidence interval (CI) 2.14-3.75; P < 0.001]. Mean PDC ± standard deviation was 0.85 ± 0.26 and 0.75 ± 0.31, respectively (P < 0.001). Patients that received the intervention were more likely to persist in their OAC therapy at 1 year (aOR 2.42, 95% CI 1.71-3.41; P < 0.001). Usual medical care was associated with more major (≥3 months) treatment gaps (aOR 2.39, 95% CI 1.76-3.26; P < 0.001). Clinical events over a median follow-up period of 2 years did not differ among treatment groups. CONCLUSION In patients receiving OAC therapy for non-valvular AF, a multilevel motivational intervention significantly improved medication adherence and rate of therapy persistence, and reduced major gaps in treatment. No significant impact on clinical outcomes was observed. TRIAL REGISTRATION NUMBER NCT02941978.",2021,"Usual medical care was associated with more major (≥3 months) treatment gaps (aOR 2.39, 95% CI 1.76-3.26; p < 0.001).","['Hospitalised patients with non-valvular AF who received OAC', '1009 patients were randomised, 500 in the intervention group and 509 in the control group', 'patients with non-valvular Atrial Fibrillation (MISOAC-AF', 'patients with non-valvular atrial fibrillation (AF']","['usual medical care or a proactive intervention, comprising motivational interviewing and tailored counseling on medication adherence', 'OAC therapy', 'Motivational Interviewing to Support Oral AntiCoagulation adherence', 'multilevel motivational intervention', 'oral anticoagulation (OAC', 'educational, motivational intervention']","['rate of persistence to OAC, gaps in treatment, and clinical events', 'medication adherence and rate of therapy persistence', 'clinical outcomes', 'Mean PDC±standard deviation', 'adherence to OAC at 1-year, which was evaluated according to Proportion of Days Covered (PDC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]","[{'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439844', 'cui_str': 'Covered'}]",1009.0,0.0949609,"Usual medical care was associated with more major (≥3 months) treatment gaps (aOR 2.39, 95% CI 1.76-3.26; p < 0.001).","[{'ForeName': 'Apostolos', 'Initials': 'A', 'LastName': 'Tzikas', 'Affiliation': 'First Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, Thessaloniki 54636, Greece.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Samaras', 'Affiliation': 'First Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, Thessaloniki 54636, Greece.'}, {'ForeName': 'Anastasios', 'Initials': 'A', 'LastName': 'Kartas', 'Affiliation': 'First Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, Thessaloniki 54636, Greece.'}, {'ForeName': 'Dimitra', 'Initials': 'D', 'LastName': 'Vasdeki', 'Affiliation': 'First Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, Thessaloniki 54636, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Fotos', 'Affiliation': 'First Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, Thessaloniki 54636, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Dividis', 'Affiliation': 'First Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, Thessaloniki 54636, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Paschou', 'Affiliation': 'First Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, Thessaloniki 54636, Greece.'}, {'ForeName': 'Evropi', 'Initials': 'E', 'LastName': 'Forozidou', 'Affiliation': 'First Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, Thessaloniki 54636, Greece.'}, {'ForeName': 'Paraskevi', 'Initials': 'P', 'LastName': 'Tsoukra', 'Affiliation': 'First Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, Thessaloniki 54636, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Kotsi', 'Affiliation': 'First Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, Thessaloniki 54636, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Goulas', 'Affiliation': 'First Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, Thessaloniki 54636, Greece.'}, {'ForeName': 'Haralambos', 'Initials': 'H', 'LastName': 'Karvounis', 'Affiliation': 'First Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, Thessaloniki 54636, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Giannakoulas', 'Affiliation': 'First Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, Thessaloniki 54636, Greece.'}]",European heart journal. Cardiovascular pharmacotherapy,['10.1093/ehjcvp/pvaa039'] 3,32342266,Application of Vitamin E Acetate on Staple Lines and Anastomoses of Roux-en-Y Gastric Bypass: Impact on Postoperative Pain and Acute Phase Reactants.,"PURPOSE Postoperative pain after laparoscopic surgery has 3 components: parietal, visceral, and associated with pneumoperitoneum. Visceral pain accounts for around 30% of the total pain and is less amenable to be controlled by multimodal analgesia. The topical application of vitamin E ointment has demonstrated an anti-inflammatory effect in the local inflammatory response against surgical aggression. Vitamin E has been also associated with a reduction in postoperative pain of skin wounds. The aim of this study was to evaluate the effect of the topical application of vitamin E acetate on staple lines and anastomoses of Roux-en-Y gastric bypass, as part of a multimodal analgesia scheme within an Enhanced Recovery After Surgery (ERAS) program. METHODS A prospective randomized clinical trial was performed. Patients were divided into 2 groups: patients receiving a topical application of vitamin E on staple lines and anastomoses (G1) and patients not receiving it (G2). The primary endpoint was postoperative pain, as measured by VAS 24 h after surgery. Secondary outcomes include morphine rescue needs, acute phase reactants 24 h after surgery, and hospital stay. RESULTS One hundred forty patients were included, 70 in each group. Postoperative pain was 10 mm in G1 and 21.8 mm in G2 (p < 0.001). Morphine needs within the first 24 h were 2.9% in G1 and 13.2% in G2 (p = 0.026). C-reactive protein levels were significantly lower in G1 (8.7 mg/dL vs 11.9; p = 0.016). Mean hospital stay was 2.1 days in G1 and 2.9 in G2 (p = 0.019). CONCLUSION Topical application of vitamin E reduces postoperative pain and acute phase reactants, allowing an earlier discharge. TRIAL REGISTRATION NCT03765827, https://www.clinicaltrials.gov.",2020,Postoperative pain was 10 mm in G1 and 21.8 mm in G2 (p < 0.001).,"['Staple Lines and Anastomoses of Roux-en-Y Gastric Bypass', 'One hundred forty patients were included, 70 in each group']","['vitamin E acetate', 'Vitamin E Acetate', 'Morphine', 'topical application of vitamin E on staple lines and anastomoses (G1) and patients not receiving it (G2', 'vitamin E', 'vitamin E ointment', 'Vitamin E']","['staple lines and anastomoses of Roux-en-Y gastric bypass', 'morphine rescue needs, acute phase reactants 24\xa0h after surgery, and hospital stay', 'Mean hospital stay', 'Visceral pain', 'postoperative pain', 'postoperative pain and acute phase reactants', 'Postoperative Pain and Acute Phase Reactants', 'Postoperative pain', 'C-reactive protein levels']","[{'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0078373', 'cui_str': 'Tocopherol Acetate'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}]","[{'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0001347', 'cui_str': 'Acute phase reactant'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0234245', 'cui_str': 'Visceral pain'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}]",140.0,0.12876,Postoperative pain was 10 mm in G1 and 21.8 mm in G2 (p < 0.001).,"[{'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Ruiz-Tovar', 'Affiliation': 'Bariatric and Metabolic Surgery Unit, Rey Juan Carlos University Hospital, Gladiolo, s/n, 28933, Madrid, Spain. jruiztovar@gmail.com.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Garcia', 'Affiliation': 'Bariatric and Metabolic Surgery Unit, Rey Juan Carlos University Hospital, Gladiolo, s/n, 28933, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ferrigni', 'Affiliation': 'Bariatric and Metabolic Surgery Unit, Rey Juan Carlos University Hospital, Gladiolo, s/n, 28933, Madrid, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Duran', 'Affiliation': 'Bariatric and Metabolic Surgery Unit, Rey Juan Carlos University Hospital, Gladiolo, s/n, 28933, Madrid, Spain.'}]",Obesity surgery,['10.1007/s11695-020-04635-9'] 4,32343960,"JNJ-56136379, an HBV Capsid Assembly Modulator, Is Well-Tolerated and Has Antiviral Activity in a Phase 1 Study of Patients With Chronic Infection.","BACKGROUND & AIMS JNJ-56136379 (JNJ-6379), a capsid assembly modulator that blocks hepatitis B virus (HBV) replication, was well tolerated and demonstrated dose-proportional pharmacokinetics in healthy participants in part 1 of its first clinical trial. In part 2, we have evaluated the safety, pharmacokinetics, and antiviral activity of multiple doses of JNJ-6379 in patients with chronic HBV infection. METHODS We performed a double-blind study of 57 treatment-naïve patients with HB e antigen-positive or -negative (74%) chronic HBV infection without cirrhosis. Patients were randomly assigned to groups given JNJ-6379 at 25 mg (100 mg loading dose), 75 mg, 150 mg, or 250 mg or placebo daily for 4 weeks with an 8-week follow-up period. RESULTS Twenty-three (56%) of 41 patients given JNJ-6379 had at least 1 adverse event (AE) during treatment, compared with 10 (63%) of 16 patients given placebo. No serious AEs were reported during the treatment period. Three patients (7%) given JNJ-6379 vs none given placebo had grade 3 AEs; of these, 1 patient (150 mg) also had an isolated grade 4 increase in the level of alanine aminotransferase that led to treatment discontinuation. JNJ-6379 exposure increased with dose, with time-linear pharmacokinetics. HBV-DNA and HBV-RNA decreased from baseline in patients receiving all doses of JNJ-6379, independently of viral genotype and HB e antigen status. On day 29, 13 (32%) of 41 patients had levels of HBV DNA below the lower limit of quantification. No clinically significant changes in levels of HB surface antigen were observed. CONCLUSIONS In a phase 1 study of treatment-naïve patients with chronic HBV infection, all doses tested of JNJ-6379 were well tolerated, showed dose-dependent pharmacokinetics, and had potent antiviral activity in patients with CHB. The findings support a phase 2a study to evaluate JNJ-6379 ± nucleos(t)ide analogs in patients with chronic HBV infection, which is under way. ClinicalTrials.gov identifier: NCT02662712.",2020,"HBV-DNA and HBV-RNA decreased from baseline in patients receiving all doses of JNJ-6379, independently of viral genotype and HB e antigen status.","['Patients with Chronic Infection', 'patients with CHB', 'patients with chronic HBV infection', 'healthy participants', '57 treatment-naïve patients with HB e antigen-positive or -negative (74%) chronic HBV infection without cirrhosis']","['JNJ-6379', 'placebo']","['levels of HBV DNA', 'level of alanine aminotransferase', 'HBV-DNA and HBV-RNA', 'safety, pharmacokinetics, and antiviral activity', 'levels of HB surface antigen']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0151317', 'cui_str': 'Chronic infectious disease'}, {'cui': 'C0151517', 'cui_str': 'Complete atrioventricular block'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019167', 'cui_str': 'Hepatitis B e antigen'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0369332', 'cui_str': 'Hepatitis B virus DNA'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0003339', 'cui_str': 'Surface Antigens'}]",,0.0672743,"HBV-DNA and HBV-RNA decreased from baseline in patients receiving all doses of JNJ-6379, independently of viral genotype and HB e antigen status.","[{'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Zoulim', 'Affiliation': 'Hepatology Unit, Hospices Civils de Lyon and Lyon University, Lyon, France; INSERM U1052-Cancer Research Institute of Lyon, Lyon, France. Electronic address: fabien.zoulim@chu-lyon.fr.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Lenz', 'Affiliation': 'Janssen Pharmaceuticals NV, Beerse, Belgium.'}, {'ForeName': 'Joris J', 'Initials': 'JJ', 'LastName': 'Vandenbossche', 'Affiliation': 'Janssen Pharmaceuticals NV, Beerse, Belgium.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'Talloen', 'Affiliation': 'Janssen Pharmaceuticals NV, Beerse, Belgium.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Verbinnen', 'Affiliation': 'Janssen Pharmaceuticals NV, Beerse, Belgium.'}, {'ForeName': 'Iurie', 'Initials': 'I', 'LastName': 'Moscalu', 'Affiliation': 'Spitalul Clinic Republican, ARENSIA EM, Chișinău, Moldova.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Streinu-Cercel', 'Affiliation': 'National Institute for Infectious Diseases ""Prof. Dr Matei Bals"", Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Bourgeois', 'Affiliation': 'ZNA Jan Palfijn, CPU, Antwerp, Belgium.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Buti', 'Affiliation': ""Hospital Universitario Vall d'Hebrón and CIBERHED del Instituto Carlos III, Barcelona, Spain.""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Crespo', 'Affiliation': 'Hospital Universitario Marqués de Valdecilla, IDIVAL Santander, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Manuel Pascasio', 'Affiliation': 'Hospital Universitario Virgen del Rocio, Seville, Spain.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Sarrazin', 'Affiliation': 'Medizinische Klinik II, St. Josefs-Hospital, Weisbaden, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Vanwolleghem', 'Affiliation': 'Erasmus MC, University Medical Center, Rotterdam, Netherlands; Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Umesh', 'Initials': 'U', 'LastName': 'Shukla', 'Affiliation': 'Janssen Pharmaceuticals R&D, Titusville, New Jersey. Electronic address: UShukla@its.jnj.com.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Fry', 'Affiliation': 'Janssen Biopharma Inc., South San Francisco, California.'}, {'ForeName': 'Jeysen Z', 'Initials': 'JZ', 'LastName': 'Yogaratnam', 'Affiliation': 'Janssen Biopharma Inc., South San Francisco, California.'}]",Gastroenterology,['10.1053/j.gastro.2020.04.036'] 5,32358874,A Comparison of the Armeo to Tabletop-assisted Therapy Exercises as Supplemental Interventions in Acute Stroke Rehabilitation: A Randomized Single Blind Study.,"OBJECTIVES To evaluate the feasibility of an additional therapeutic upper limb exercise (ULE) intervention in early phase post-stroke rehabilitation and to assess outcomes of therapy using the Armeo Spring (ARMEO) versus Therapist-assisted Table Top (TAT) interventions. DESIGN Randomized, single-blind trial. SETTING Stroke acute inpatient rehabilitation unit. PARTICIPANTS Forty-five participants early after first stroke, Fugl-Meyer Assessment (FMA) score >8, Modified Ashworth score (MAS) of <3. INTERVENTIONS Participants were randomized to TAT or ARMEO ULE in addition to the required 3 hours of 1:1 standard of care provided in an inpatient rehabilitation facility (IRF). MAIN OUTCOME MEASURES Completed number of treatments; withdrawals; serious/adverse events; Functional Independence Measure (FIM) motor; FIM efficiency; FMA; MAS; elbow active (A) and passive (P) range of motion (ROM); and therapist effort measured by the Modified Borg Rating of Perceived Exertion Scale (RPE). RESULTS Post-intervention FIM and FMA scores increased but did not demonstrate any statistically significant differences between the intervention groups (P = .585, .962, partial n 2 = .001, .001, respectively). There were no statistically significant differences in post-intervention MAS elbow flexion and extension (P = .332, .252, partial n 2 = .009, .007, respectively) and A/P ROM elbow extension between training groups (P = .841, .731, partial n 2 = .001, .003, respectively). There was a statistically significant difference in post-intervention A/P ROM elbow flexion between groups (P = .031, .018, partial n 2 = .123, .146). Post-intervention RPE did not show any statistically significant differences between the training groups (P = .128, partial n 2 = .063). Total elbow range showed larger adjusted mean gains for the ARMEO. No serious adverse events were reported. CONCLUSIONS This study demonstrates that additional therapeutic ULE in the early phase of post-stroke inpatient rehabilitation is feasible and that both interventions showed positive changes in selected outcomes.",2021,"RESULTS Post-intervention FIM and FMA scores increased but did not demonstrate any statistically significant differences between the intervention groups (p = .585, .962, partial n 2 = .001,","['45 participants early after first stroke, Fugl Meyer Assessment (FMA) score >\u20098, Modified Ashworth score (MAS) of <3', 'Stroke acute inpatient rehabilitation unit', 'Acute Stroke Rehabilitation']","['additional therapeutic upper limb exercise (ULE) intervention', 'TAT or ARMEO ULE', 'inpatient rehabilitation facility (IRF', 'Therapist assisted Table Top (TAT) interventions', 'Armeo Spring ® (ARMEO) VS']","['post-intervention MAS elbow flexion and extension', 'P ROM elbow flexion', 'FMA scores', 'P ROM elbow extension', 'serious adverse events (SAEs', 'Completed number of treatments; withdrawals; serious/adverse events; Functional Independence Measure (FIM) Motor; FIM efficiency; FMA; MAS; elbow active (A) and passive (P) range of motion (ROM) and therapist effort measured by the Modified Borg Rating of Perceived Exertion Scale (RPE']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0454320', 'cui_str': 'Upper limb exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039224', 'cui_str': 'Table'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C3845566', 'cui_str': 'Rehabilitation facility'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",45.0,0.166516,"RESULTS Post-intervention FIM and FMA scores increased but did not demonstrate any statistically significant differences between the intervention groups (p = .585, .962, partial n 2 = .001,","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Esquenazi', 'Affiliation': 'Department of PM&R, MossRehab, Elkins Park, PA, USA.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of PM&R, MossRehab, Elkins Park, PA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Watanabe', 'Affiliation': 'Department of PM&R, MossRehab, Elkins Park, PA, USA.'}, {'ForeName': 'Alexey', 'Initials': 'A', 'LastName': 'Nastaskin', 'Affiliation': 'Department of PM&R, MossRehab, Elkins Park, PA, USA.'}, {'ForeName': 'Casey', 'Initials': 'C', 'LastName': 'McKee', 'Affiliation': 'Department of PM&R, MossRehab, Elkins Park, PA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': ""O'Neill"", 'Affiliation': 'Department of PM&R, MossRehab, Elkins Park, PA, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Scheponik', 'Affiliation': 'Department of PM&R, MossRehab, Elkins Park, PA, USA.'}, {'ForeName': 'Jaun', 'Initials': 'J', 'LastName': 'May', 'Affiliation': 'Department of PM&R, MossRehab, Elkins Park, PA, USA.'}]","PM & R : the journal of injury, function, and rehabilitation",['10.1002/pmrj.12397'] 6,32351164,"A phase 2 multicenter study of ublituximab, a novel glycoengineered anti-CD20 monoclonal antibody, in patients with relapsing forms of multiple sclerosis.","BACKGROUND Ublituximab, a novel monoclonal antibody (mAb) targeting a unique epitope on the CD20 antigen, is glycoengineered for enhanced B-cell targeting through antibody-dependent cellular cytotoxicity (ADCC). Greater ADCC may allow lower doses and shorter infusion times versus other anti-CD20 mAbs. OBJECTIVE The objective was to determine optimal dose, infusion time, and activity of ublituximab in relapsing multiple sclerosis. METHODS This is a phase 2, placebo-controlled study. Patients received three ublituximab infusions (150 mg over 1-4 hours on day 1 and 450-600 mg over 1-3 hours on day 15 and week 24) in six dosing cohorts. The primary endpoint was B-cell depletion. RESULTS In all cohorts ( N  = 48), median B-cell depletion was >99% by week 4, maintained at weeks 24 and 48. Most common adverse events (AEs) were infusion-related reactions (all grade 1-2), with no apparent increased incidence at shorter infusion times. There were no AE-related discontinuations. At weeks 24 and 48, no T1 gadolinium-enhancing lesions ( p  = 0.003) and a 10.6% decrease in T2 lesion volume ( p  = 0.002) were detected. The annualized relapse rate was 0.07; 93% remained relapse free on study. Overall, 74% of patients had no evidence of disease activity (NEDA). CONCLUSION Ublituximab was safely infused as rapid as 1 hour, producing robust B-cell depletion and profound reductions in magnetic resonance imaging (MRI) activity and relapses.",2021,"At weeks 24 and 48, no T1 gadolinium-enhancing lesions ( p  = 0.003) and a 10.6% decrease in T2 lesion volume ( p  = 0.002) were detected.",['patients with relapsing forms of multiple sclerosis'],"['ublituximab', 'glycoengineered anti-CD20 monoclonal antibody', 'ublituximab infusions', 'placebo']","['magnetic resonance imaging (MRI) activity and relapses', 'B-cell depletion', 'disease activity (NEDA', 'annualized relapse rate', 'T2 lesion volume', 'median B-cell depletion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C4083151', 'cui_str': 'ublituximab'}, {'cui': 'C0796614', 'cui_str': 'ocaratuzumab'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.0336332,"At weeks 24 and 48, no T1 gadolinium-enhancing lesions ( p  = 0.003) and a 10.6% decrease in T2 lesion volume ( p  = 0.002) were detected.","[{'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Fox', 'Affiliation': 'Central Texas Neurology Consultants, Round Rock, TX, USA.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Lovett-Racke', 'Affiliation': 'Department of Microbial Infection and Immunity, The Ohio State University Wexner Medical Center, Columbus, OH, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Gormley', 'Affiliation': 'Department of Microbial Infection and Immunity, The Ohio State University Wexner Medical Center, Columbus, OH, USA.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Microbial Infection and Immunity, The Ohio State University Wexner Medical Center, Columbus, OH, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Petracca', 'Affiliation': 'Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Sirio', 'Initials': 'S', 'LastName': 'Cocozza', 'Affiliation': 'Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, USA/Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Shubin', 'Affiliation': 'SC3 Research Group, Inc., Pasadena, CA, USA.'}, {'ForeName': 'Sibyl', 'Initials': 'S', 'LastName': 'Wray', 'Affiliation': 'Hope Neurology Multiple Sclerosis Center, Knoxville, TN, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Weiss', 'Affiliation': 'TG Therapeutics, Inc., New York, NY, USA.'}, {'ForeName': 'Jenna A', 'Initials': 'JA', 'LastName': 'Bosco', 'Affiliation': 'TG Therapeutics, Inc., New York, NY, USA.'}, {'ForeName': 'Sean A', 'Initials': 'SA', 'LastName': 'Power', 'Affiliation': 'TG Therapeutics, Inc., New York, NY, USA.'}, {'ForeName': 'Koby', 'Initials': 'K', 'LastName': 'Mok', 'Affiliation': 'TG Therapeutics, Inc., New York, NY, USA.'}, {'ForeName': 'Matilde', 'Initials': 'M', 'LastName': 'Inglese', 'Affiliation': 'Medical Center, Department of Neurology, Radiology and Neuroscience, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458520918375'] 7,32358235,The Role of Postoperative Bandage Contact Lens in Patients Undergoing Fasanella-Servat Ptosis Repair.,"PURPOSE To determine whether a bandage contact lens (BCL) improves patient comfort in the postoperative period in patients undergoing ptosis repair using the Fasanella-Servat technique, compared with no BCL. METHODS In this prospective, randomized, double-masked, comparison study, all patients had bilateral Fasanella-Servat surgery. A total of 30 patients were randomized to receive a BCL in one eye and no BCL in the other eye. Patient discomfort was measured as the primary outcome using the Eye Sensation Scale. Blurred vision was measured as a secondary outcome using selected questions from the Ocular Surface Disease Index. The surgeries were performed by 2 surgeons (J.T.H and R.S.A). Outcomes were measured one week following the procedure. RESULTS Patients reported significantly less discomfort in the eye receiving a BCL, with only 13.3% ranking discomfort as ""moderate"" or ""severe,"" compared with the eye not receiving BCL, where 63.3% of patients rated discomfort as ""moderate"" or ""severe"" (p < 0.001). There was no significant difference in patient-reported blurred vision between the 2 groups (p = 0.520). CONCLUSIONS The use of a bandage contact lens after Fasanella-Servat procedure for ptosis repair is recommended as it improves patient comfort. In addition, it has no detrimental effect on patient-reported blurring of vision.",2021,"There was no significant difference in patient-reported blurred vision between the 2 groups (p = 0.520). ","['patients had bilateral Fasanella-Servat surgery', 'patients undergoing ptosis repair using the Fasanella-Servat technique, compared with no BCL', '30 patients', 'Patients Undergoing Fasanella-Servat Ptosis Repair']","['Postoperative Bandage Contact Lens', 'bandage contact lens (BCL', 'BCL in one eye and no BCL']","['Blurred vision', 'blurred vision', 'Eye Sensation Scale', 'rated discomfort as ""moderate"" or ""severe', 'discomfort', 'Patient discomfort']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0197280', 'cui_str': 'Repair of blepharoptosis'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0004726', 'cui_str': 'Bandage'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1444754', 'cui_str': 'Length'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004726', 'cui_str': 'Bandage'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1562032', 'cui_str': 'Bandage contact lens'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0344232', 'cui_str': 'Hazy vision'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",30.0,0.133509,"There was no significant difference in patient-reported blurred vision between the 2 groups (p = 0.520). ","[{'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Adam', 'Affiliation': 'Hamilton Regional Eye Institute.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Harvey', 'Affiliation': 'Hamilton Regional Eye Institute.'}, {'ForeName': 'Jonah N', 'Initials': 'JN', 'LastName': 'Gould', 'Affiliation': 'Michael G. DeGroote School of Medicine.'}, {'ForeName': 'Sivisan', 'Initials': 'S', 'LastName': 'Suntheralingam', 'Affiliation': 'Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Forough', 'Initials': 'F', 'LastName': 'Farrokhyar', 'Affiliation': 'Department of Surgery, McMaster University, Hamilton.'}]",Ophthalmic plastic and reconstructive surgery,['10.1097/IOP.0000000000001690'] 8,32358259,Evaluation of total corneal power measurements with a new optical biometer.,"PURPOSE To evaluate the repeatability and validity of total corneal power measurements (total keratometry [TK]) obtained with a recently introduced optical biometer (IOLMaster 700, Carl Zeiss Meditec AG) to a Scheimpflug device (Pentacam, Oculus). SETTING Department of Ophthalmology, Ludwig-Maximilians-University, Munich, Germany. DESIGN Prospective randomized controlled trial. METHODS The inclusion criteria were a corneal astigmatism of 3.00 diopters (D) or less, no previous ocular surgery, no known corneal irregularities, and no known dry eyes. All eyes were measured 3 times using the optical biometer and the Scheimpflug device. The results were statistically compared using Bland-Altman, within-subject SD, and astigmatism vector analysis. RESULTS Ninety-three eyes of 93 subjects were included. Overall, the repeatability of all eyes measured was 0.42 for standard K, 0.40 for TK, 0.45 for total corneal refractive power (TCRP), 0.43 for true net power (TNP), and 0.39 for simulated K. Bland-Altman analysis showed no significant difference between the optical biometer's TK compared with standard K and the Scheimpflug device's simulated K, TNP, and TCRP, the P value exceeding .05 in each case. A difference of >0.50 diopters between astigmatism measurements between TK and TCRP was found in 10 cases compared with standard K and TNP with 0 and 2 cases. CONCLUSIONS Repeatability of both devices was high, although measurements of meridian showed a great variability, suggesting that numerous measurements are needed to enhance accuracy. TCRP measurements between recently introduced TK and TCRP cannot be used interchangeably. Future studies are necessary to evaluate which measurement will result in a better outcome when respective measurements are used for toric intraocular lens calculations.",2020,"Overall, the repeatability of all eyes measured was 0.42 for standard K, 0.40 for TK, 0.45 for total corneal refractive power (TCRP), 0.43 for true net power (TNP), and 0.39 for simulated K. Bland-Altman analysis showed no significant difference between the optical biometer's TK compared with standard K and the Scheimpflug device's simulated K, TNP, and TCRP, the P value exceeding .05 in each case.","['Department of Ophthalmology, Ludwig-Maximilians-University, Munich, Germany', 'The inclusion criteria were a corneal astigmatism of 3.00 diopters (D) or less, no previous ocular surgery, no known corneal irregularities, and no known dry eyes', 'Ninety-three eyes of 93 subjects were included']",['total corneal power measurements (total keratometry [TK'],"['total corneal refractive power (TCRP', 'TCRP measurements']","[{'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0024081', 'cui_str': ""Ludwig's angina""}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0339682', 'cui_str': 'Regular astigmatism - corneal'}, {'cui': 'C0439484', 'cui_str': 'Diopters'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1705869', 'cui_str': 'Ophthalmic surgery'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0430885', 'cui_str': 'Keratometry'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0429520', 'cui_str': 'Refractive power'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",93.0,0.0716156,"Overall, the repeatability of all eyes measured was 0.42 for standard K, 0.40 for TK, 0.45 for total corneal refractive power (TCRP), 0.43 for true net power (TNP), and 0.39 for simulated K. Bland-Altman analysis showed no significant difference between the optical biometer's TK compared with standard K and the Scheimpflug device's simulated K, TNP, and TCRP, the P value exceeding .05 in each case.","[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Shajari', 'Affiliation': 'From the Department of Ophthalmology, Ludwig-Maximilians University (Shajari, Sonntag, Ramsauer, Kreutzer, Vounotrypidis, Priglinger, Mayer), Munich, Department of Ophthalmology (Shajari, Kohnen), Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Ruven', 'Initials': 'R', 'LastName': 'Sonntag', 'Affiliation': ''}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Ramsauer', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kreutzer', 'Affiliation': ''}, {'ForeName': 'Efstathios', 'Initials': 'E', 'LastName': 'Vounotrypidis', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kohnen', 'Affiliation': ''}, {'ForeName': 'Siegfried', 'Initials': 'S', 'LastName': 'Priglinger', 'Affiliation': ''}, {'ForeName': 'Wolfgang J', 'Initials': 'WJ', 'LastName': 'Mayer', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000136'] 9,32350785,Coagulation ability when separating from cardiopulmonary bypass with and without fresh frozen plasma: a pilot study.,"OBJECTIVE Several strategies are employed for administering fresh frozen plasma (FFP) during weaning from cardiopulmonary bypass (CPB). This study evaluated by coagulation function aimed to compare two strategies of administering FFP in cardiovascular surgery: administering 4 units of FFP before separating from CPB or administering it after weaning from CPB. METHODS Thirty patients who underwent CPB and were expected to receive 8 units of FFP and 20 units of platelet concentrate were randomly allocated into group A (8 units of FFP and 20 units of platelet concentrate administered after separating from CPB) and group B (4 units of FFP administered before separation, and 4 units of FFP and 20 units of platelet concentrate administered after separating from CPB). Thromboelastography (TEG6s ® , HAEMONETICS Japan GK, Tokyo, Japan) was conducted at four time points before and after separation. Blood test results, blood loss, and required amounts of blood transfusion were compared. The primary outcome was the difference in coagulation function evaluated by TEG6s 90 min after protamine administration. RESULTS Twenty-eight patients were enrolled in the study. Coagulation function after separating from CPB was not significantly different between the groups. Additionally, no significant differences were found in intensive care unit outcomes, such as 24-h transfusion requirements. CONCLUSIONS Coagulation function 90 min after separating from CPB was not significantly different between the groups. Prior FFP administration before separation did not provide significant improvement in coagulation function.",2020,Coagulation function after separating from CPB was not significantly different between the groups.,"['Twenty-eight patients were enrolled in the study', 'Thirty patients who underwent CPB and were expected to receive 8 units of FFP and 20 units of platelet concentrate', 'cardiovascular surgery: administering 4 units of FFP before separating from CPB or administering it after weaning from CPB']","['Thromboelastography (TEG6s ®', 'FFP and 20 units of platelet concentrate administered after separating from CPB', 'FFP']","['intensive care unit outcomes, such as 24-h transfusion requirements', 'Coagulation ability', 'blood loss, and required amounts of blood transfusion', 'Coagulation function', 'coagulation function']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0016709', 'cui_str': 'Fresh frozen plasma'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0038897', 'cui_str': 'Cardiovascular surgical procedure'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0443299', 'cui_str': 'Separate'}]","[{'cui': 'C0040017', 'cui_str': 'Thromboelastography'}, {'cui': 'C0016709', 'cui_str': 'Fresh frozen plasma'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",28.0,0.058247,Coagulation function after separating from CPB was not significantly different between the groups.,"[{'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Tamura', 'Affiliation': 'Department of Anesthesiology, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-Ku, Nagoya, 466-8550, Japan. takahiro@med.nagoya-u.ac.jp.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Yokota', 'Affiliation': 'Division of Anesthesiology, Japanese Red Cross Nagoya Daiichi Hospital, Nagoya, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Ito', 'Affiliation': 'Division of Cardiovascular Surgery, Japanese Red Cross Nagoya Daiichi Hospital, Nagoya, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Kubo', 'Affiliation': 'Department of Preventive Medicine, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Jonathan H', 'Initials': 'JH', 'LastName': 'Waters', 'Affiliation': 'Department of Anesthesiology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Kimitoshi', 'Initials': 'K', 'LastName': 'Nishiwaki', 'Affiliation': 'Department of Anesthesiology, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-Ku, Nagoya, 466-8550, Japan.'}]",General thoracic and cardiovascular surgery,['10.1007/s11748-020-01372-9'] 10,32367175,Impact of a 12-Week Randomized Exercise Training Program on Lipid Profile in Severely Obese Patients Following Bariatric Surgery.,"PURPOSE The benefit of exercise training on lipid profile in bariatric surgery patients is scarce. We assess the effect of a supervised exercise-training program on lipid profile following bariatric surgery. MATERIALS AND METHODS A total of 60 patients were prospectively recruited, of those 49 completed the study (age 41 ± 11 years; body mass index 45.9 ± 6.1 kg/m 2 , 75% women). The bariatric surgery procedures performed were sleeve gastrectomy (SG) (n = 24) and biliopancreatic diversion with duodenal switch (BPD-DS) (n = 25). Of the 49 patients who completed the study, 34 had been randomized to a 12-week supervised exercise training program (exercise group) between the 3rd and the 6th month following bariatric surgery (SG = 17 and BPD-DS = 17). Fasting blood samples and anthropometric measurements were performed preoperatively and at 3, 6, and 12 months after bariatric surgery. RESULTS At 6 months and 12 months, percentage of weight loss was similar between groups (6 months: - 29.6 ± 5.5 vs. - 27.8 ± 7.7%; P = 0.371; 12 months: - 38.4 ± 10.4 vs. - 37.9 ± 9.5%; P = 0.876 exercise vs. control). Both groups had an increase in HDL values between the 3nd and the 6th month following bariatric surgery. There was a significantly greater increment in HDL values in the exercise group (0.18 ± 0.14 vs. 0.07 ± 0.12 mmol/L, P = 0.014; exercise vs. control). CONCLUSION Our results showed a beneficial effect of a 12-week supervised exercise-training program in bariatric surgery patients showing similar weight loss on HDL-cholesterol levels without additional effect on LDL-cholesterol levels.",2020,"At 6 months and 12 months, percentage of weight loss was similar between groups (6 months: - 29.6 ± 5.5 vs. - 27.8 ± 7.7%; P = 0.371; 12 months: - 38.4 ± 10.4 vs. - 37.9 ± 9.5%; P = 0.876 exercise vs. control).","['bariatric surgery patients', '49 patients who completed the study, 34 had been randomized to a 12-week', 'Severely Obese Patients Following Bariatric Surgery', 'A total of 60 patients were prospectively recruited, of those 49 completed the study (age 41\u2009±\u200911\xa0years; body mass index 45.9\u2009±\u20096.1\xa0kg/m 2 , 75% women']","['exercise training', 'sleeve gastrectomy (SG', 'biliopancreatic diversion with duodenal switch (BPD-DS', 'Exercise Training Program', 'supervised exercise-training program', 'supervised exercise training program (exercise']","['LDL-cholesterol levels', 'HDL values', 'Lipid Profile', 'HDL-cholesterol levels', 'percentage of weight loss', 'Fasting blood samples and anthropometric measurements']","[{'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0005435', 'cui_str': 'Biliopancreatic bypass'}, {'cui': 'C1960687', 'cui_str': 'Duodenal switch'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",60.0,0.0218751,"At 6 months and 12 months, percentage of weight loss was similar between groups (6 months: - 29.6 ± 5.5 vs. - 27.8 ± 7.7%; P = 0.371; 12 months: - 38.4 ± 10.4 vs. - 37.9 ± 9.5%; P = 0.876 exercise vs. control).","[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Tardif', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Auclair', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'Marie-Eve', 'Initials': 'ME', 'LastName': 'Piché', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Biertho', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Marceau', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'Frédéric-Simon', 'Initials': 'FS', 'LastName': 'Hould', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Biron', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'Stéfane', 'Initials': 'S', 'LastName': 'Lebel', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'Odette', 'Initials': 'O', 'LastName': 'Lescelleur', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Poirier', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Québec, Québec, Canada. paul.poirier@criucpq.ulaval.ca.'}]",Obesity surgery,['10.1007/s11695-020-04647-5'] 11,32348539,Impact of Systemic Dipeptidyl Peptidase-4 Inhibitor Use in Diabetic Macular Edema.,"BACKGROUND AND OBJECTIVE To evaluate impact of baseline systemic dipeptidyl peptidase-4 (DPP-4) inhibitor use in diabetic macular edema (DME). PATIENTS AND METHODS This was a post hoc exploratory analysis of previously completed randomized, controlled clinical trials (VISTA and VIVID) in patients with DME evaluating intravitreal aflibercept injection (IAI) every 4 weeks (2q4) or every 8 weeks (2q8) or macular laser photocoagulation. RESULTS Overall, a small number of patients (12.2% [n = 35], 9.7% [n = 28], and 15.4% [n = 44]) in the laser control, 2q4, and 2q8 groups reported baseline DPP-4 inhibitor use. There were no differences in changes from baseline in best-corrected visual acuity, central subfield thickness, or rates of 2-or-greater-step improvement in Diabetic Retinopathy Severity Scale score based on DPP-4 inhibitor use within each treatment group. CONCLUSION DPP-4 inhibitor use at baseline did not influence the magnitude of visual and anatomic benefit in patients with DME being treated with IAI or laser. [Ophthalmic Surg Lasers Imaging Retina. 2020;51:226-234.].",2020,"There were no differences in changes from baseline in best-corrected visual acuity, central subfield thickness, or rates of 2-or-greater-step improvement in Diabetic Retinopathy Severity Scale score based on DPP-4 inhibitor use within each treatment group. ","['Diabetic Macular Edema', 'patients with DME evaluating intravitreal aflibercept injection (IAI) every 4 weeks (2q4) or every 8 weeks (2q8) or', 'diabetic macular edema (DME', 'patients with DME being treated with IAI or laser']","['Systemic Dipeptidyl Peptidase-4 Inhibitor Use', 'macular laser photocoagulation', 'baseline systemic dipeptidyl peptidase-4 (DPP-4) inhibitor']","['magnitude of visual and anatomic benefit', 'best-corrected visual acuity, central subfield thickness, or rates of 2-or-greater-step improvement in Diabetic Retinopathy Severity Scale score']","[{'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0585337', 'cui_str': 'Bimonthly'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0023694', 'cui_str': 'Photocoagulation'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0081937', 'cui_str': 'Dipeptidyl peptidase IV'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.233762,"There were no differences in changes from baseline in best-corrected visual acuity, central subfield thickness, or rates of 2-or-greater-step improvement in Diabetic Retinopathy Severity Scale score based on DPP-4 inhibitor use within each treatment group. ","[{'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Rahimy', 'Affiliation': ''}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Baker', 'Affiliation': ''}, {'ForeName': 'Desmond', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': ''}, {'ForeName': 'Namrata', 'Initials': 'N', 'LastName': 'Saroj', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Ophthalmic surgery, lasers & imaging retina",['10.3928/23258160-20200326-04'] 12,32297974,Interventions for fatigue in inflammatory bowel disease.,"BACKGROUND Inflammatory bowel disease (IBD) is an umbrella term used to describe a group of chronic, progressive inflammatory disorders of the digestive tract. Crohn's disease and ulcerative colitis are the two main types. Fatigue is a common, debilitating and burdensome symptom experienced by individuals with IBD. The subjective, complex nature of fatigue can often hamper its management. The efficacy and safety of pharmacological or non-pharmacological treatments for fatigue in IBD is not yet established through systematic review of studies. OBJECTIVES To assess the efficacy and safety of pharmacological and non-pharmacological interventions for managing fatigue in IBD compared to no treatment, placebo or active comparator. SEARCH METHODS A systematic search of the databases Embase, MEDLINE, Cochrane Library, CINAHL, PsycINFO was undertaken from inception to July 2018. A top-up search was run in October 2019. We also searched the Cochrane IBD Group Specialized Register, the Cochrane Central Register of Controlled Trials, ongoing trials and research registers, conference abstracts and reference lists for potentially eligible studies. SELECTION CRITERIA Randomised controlled trials of pharmacological and non-pharmacological interventions in children or adults with IBD, where fatigue was assessed as a primary or secondary outcome using a generic or disease-specific fatigue measure, a subscale of a larger quality of life scale or as a single-item measure, were included. DATA COLLECTION AND ANALYSIS Two authors independently screened search results and four authors extracted and assessed bias independently using the Cochrane 'Risk of bias' tool. The primary outcome was fatigue and the secondary outcomes included quality of life, adverse events (AEs), serious AEs and withdrawal due to AEs. Standard methodological procedures were used. MAIN RESULTS We included 14 studies (3741 participants): nine trials of pharmacological interventions and five trials of non-pharmacological interventions. Thirty ongoing studies were identified, and five studies are awaiting classification. Data on fatigue were available from nine trials (1344 participants). In only four trials was managing fatigue the primary intention of the intervention (electroacupuncture, physical activity advice, cognitive behavioural therapy and solution-focused therapy). Electroacupuncture Fatigue was measured with Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) (scores range from 0 to 52). The FACIT-F score at week eight was 8.00 points higher (better) in participants receiving electroacupuncture compared with no treatment (mean difference (MD) 8.00, 95% CI 6.45 to 9.55; 1 RCT; 27 participants; low-certainty evidence). Results at week 16 could not be calculated. FACIT-F scores were also higher with electroacupuncture compared to sham electroacupuncture at week eight (MD 5.10, 95% CI 3.49 to 6.71; 1 RCT; 30 participants; low-certainty evidence) but not at week 16 (MD 2.60, 95% CI 0.74 to 4.46; 1 RCT; 30 participants; low-certainty evidence). No adverse events were reported, except for one adverse event in the sham electroacupuncture group. Cognitive behavioural therapy (CBT) and solution-focused therapy Compared with a fatigue information leaflet, the effects of CBT on fatigue are very uncertain (Inflammatory Bowel Disease-Fatigue (IBD-F) section I: MD -2.16, 95% CI -6.13 to 1.81; IBD-F section II: MD -21.62, 95% CI -45.02 to 1.78; 1 RCT, 18 participants, very low-certainty evidence). The efficacy of solution-focused therapy on fatigue is also very uncertain, because standard summary data were not reported (1 RCT, 98 participants). Physical activity advice One 2 x 2 factorial trial (45 participants) found physical activity advice may reduce fatigue but the evidence is very uncertain. At week 12, compared to a control group receiving no physical activity advice plus omega 3 capsules, FACIT-F scores were higher (better) in the physical activity advice plus omega 3 group (FACIT-F MD 6.40, 95% CI -1.80 to 14.60, very low-certainty evidence) and the physical activity advice plus placebo group (FACIT-F MD 9.00, 95% CI 1.64 to 16.36, very low-certainty evidence). Adverse events were predominantly gastrointestinal and similar across physical activity groups, although more adverse events were reported in the no physical activity advice plus omega 3 group. Pharmacological interventions Compared with placebo, adalimumab 40 mg, administered every other week ('eow') (only for those known to respond to adalimumab induction therapy), may reduce fatigue in patients with moderately-to-severely active Crohn's disease, but the evidence is very uncertain (FACIT-F MD 4.30, 95% CI 1.75 to 6.85; very low-certainty evidence). The adalimumab 40 mg eow group was less likely to experience serious adverse events (OR 0.56, 95% CI 0.33 to 0.96; 521 participants; moderate-certainty evidence) and withdrawal due to adverse events (OR 0.48, 95%CI 0.26 to 0.87; 521 participants; moderate-certainty evidence). Ferric maltol may result in a slight increase in fatigue, with better SF-36 vitality scores reported in the placebo group compared to the treatment group following 12 weeks of treatment (MD -9.31, 95% CI -17.15 to -1.47; 118 participants; low-certainty evidence). There may be little or no difference in adverse events (OR 0.55, 95% CI 0.26 to 1.18; 120 participants; low-certainty evidence) AUTHORS' CONCLUSIONS: The effects of interventions for the management of fatigue in IBD are uncertain. No firm conclusions regarding the efficacy and safety of interventions can be drawn. Further high-quality studies, with a larger number of participants, are required to assess the potential benefits and harms of therapies. Future studies should assess interventions specifically designed for fatigue management, targeted at selected IBD populations, and measure fatigue as the primary outcome.",2020,"The FACIT-F score at week eight was 8.00 points higher (better) in participants receiving electroacupuncture compared with no treatment (mean difference (MD) 8.00, 95% CI 6.45 to 9.55; 1 RCT; 27 participants; low-certainty evidence).","['14 studies (3741 participants): nine trials of pharmacological interventions and five trials of non-pharmacological interventions', 'children or adults with IBD']","['placebo, adalimumab', 'Cognitive behavioural therapy (CBT) and solution-focused therapy', 'intervention (electroacupuncture, physical activity advice, cognitive behavioural therapy and solution-focused therapy', 'placebo', 'pharmacological and non-pharmacological interventions', 'electroacupuncture', 'physical activity advice', 'CBT', 'adalimumab', 'sham electroacupuncture', 'physical activity advice plus placebo']","['adverse events', 'Adverse events', 'quality of life, adverse events (AEs), serious AEs and withdrawal due to AEs', ""Crohn's disease and ulcerative colitis"", 'FACIT-F scores', 'Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F', 'fatigue', 'efficacy and safety', 'generic or disease-specific fatigue measure, a subscale of a larger quality of life scale', 'experience serious adverse events', 'moderate-certainty evidence) and withdrawal due to adverse events', 'FACIT-F score', 'Electroacupuncture Fatigue', 'SF-36 vitality scores']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}]",45.0,0.243237,"The FACIT-F score at week eight was 8.00 points higher (better) in participants receiving electroacupuncture compared with no treatment (mean difference (MD) 8.00, 95% CI 6.45 to 9.55; 1 RCT; 27 participants; low-certainty evidence).","[{'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Farrell', 'Affiliation': 'Institute of Technology Tralee, Department of Nursing and Healthcare Sciences, Tralee, County Kerry, Ireland.'}, {'ForeName': 'Micol', 'Initials': 'M', 'LastName': 'Artom', 'Affiliation': ""King's College London, Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, 57 Waterloo Road, London, UK, SE1 8WA.""}, {'ForeName': 'Wladyslawa', 'Initials': 'W', 'LastName': 'Czuber-Dochan', 'Affiliation': ""King's College London, Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, 57 Waterloo Road, London, UK, SE1 8WA.""}, {'ForeName': 'Lars P', 'Initials': 'LP', 'LastName': 'Jelsness-Jørgensen', 'Affiliation': 'Østfold University College, Health Sciences, Høgskolen i Østfold, Postboks 700, Halden, Norway, NO-1757.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Norton', 'Affiliation': ""King's College London, Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, 57 Waterloo Road, London, UK, SE1 8WA.""}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Savage', 'Affiliation': 'University College Cork, School of Nursing and Midwifery, Brookfield Health Sciences Complex, Cork, Ireland.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012005.pub2'] 13,32357364,PROMPT intervention for children with severe speech motor delay: a randomized control trial.,"BACKGROUND Currently, there is limited information on the intervention efficacy for children with speech motor delay (SMD). This randomized control trial (RCT) study examined the effectiveness of Prompts for Restructuring Oral Muscular Phonetic Targets (PROMPT) intervention to improve the outcomes in children with SMD. We hypothesized that children with SMD receiving PROMPT intervention would improve more in the measured outcomes than those waitlisted and receiving home training. METHODS Using a two-arm, parallel group, RCT, 49 children with SMD were allocated to either an intervention group (N = 24) that received 45 min of PROMPT intervention two times a week for 10 weeks or were waitlisted for the same duration and received only home training instructions (N = 25). Outcome measures for speech motor control, articulation, speech intelligibility (word and sentence levels), and functional communication were assessed at baseline and at a 10-week follow-up. RESULTS PROMPT intervention was associated with notable improvements in speech motor control, speech articulation, and word-level speech intelligibility. Intervention allocation yielded weak improvements in sentence-level speech intelligibility and functional communication. CONCLUSIONS PROMPT intervention is a clinically effective intervention approach for children with SMD. IMPACT Currently, there is limited information on the intervention efficacy for children with SMD. We report on the findings of a phase III intervention efficacy study on children with SMD using an RCT design. PROMPT intervention is a clinically effective intervention approach for children with SMD. Results of the study will be fundamental to the delivery of effective services for this population. These findings may facilitate the development of an evidence-based care pathway for children with severe speech sound disorders.",2021,"RESULTS PROMPT intervention was associated with notable improvements in speech motor control, speech articulation, and word-level speech intelligibility.","['children with SMD', 'children with severe speech motor delay', 'children with SMD receiving', 'children with severe speech sound disorders', 'children with speech motor delay (SMD', '49 children with SMD']","['PROMPT intervention', 'Restructuring Oral Muscular Phonetic Targets (PROMPT) intervention', 'intervention group (N\u2009=\u200924) that received 45\u2009min of PROMPT intervention two times a week for 10 weeks or were waitlisted for the same duration and received only home training instructions']","['speech motor control, speech articulation, and word-level speech intelligibility', 'speech motor control, articulation, speech intelligibility (word and sentence levels), and functional communication', 'sentence-level speech intelligibility and functional communication']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0520947', 'cui_str': 'Clumsiness - motor delay'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4019167', 'cui_str': 'Speech sound disorder'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0031579', 'cui_str': 'Phonetics'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",49.0,0.0401986,"RESULTS PROMPT intervention was associated with notable improvements in speech motor control, speech articulation, and word-level speech intelligibility.","[{'ForeName': 'Aravind K', 'Initials': 'AK', 'LastName': 'Namasivayam', 'Affiliation': 'Oral Dynamics Laboratory, Department of Speech-Language Pathology, University of Toronto, Toronto, ON, Canada. a.namasivayam@utoronto.ca.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Huynh', 'Affiliation': 'Oral Dynamics Laboratory, Department of Speech-Language Pathology, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Granata', 'Affiliation': 'Oral Dynamics Laboratory, Department of Speech-Language Pathology, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Vina', 'Initials': 'V', 'LastName': 'Law', 'Affiliation': 'Oral Dynamics Laboratory, Department of Speech-Language Pathology, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'van Lieshout', 'Affiliation': 'Oral Dynamics Laboratory, Department of Speech-Language Pathology, University of Toronto, Toronto, ON, Canada.'}]",Pediatric research,['10.1038/s41390-020-0924-4'] 14,32356074,"A Randomized, Controlled, Pilot Study of CPAP for Patients with Chronic Cough and Obstructive Sleep Apnea.","BACKGROUND An association between chronic cough and obstructive sleep apnea (OSA) has been reported in prior studies with resolution or improvement in cough after continuous positive airway pressure (CPAP) therapy. Controlled studies of the benefit of CPAP on cough-quality of life measures have not been conducted. RESEARCH QUESTION Does CPAP therapy for OSA improve cough in patients with chronic unexplained cough? STUDY DESIGN AND METHODS Patients with unexplained chronic cough (> 2 months duration of cough) and OSA were randomized to receive either CPAP or sham CPAP therapy for 6 weeks. The primary end point was the change in health status assessed with the Leicester Cough Questionnaire (LCQ) in patients treated with CPAP vs. sham CPAP. Secondary end points were changes in exhaled breath condensate markers of airway inflammation (interleukin-6, nitrite/nitrates, hydrogen peroxide and 8-isoprostanes). RESULTS A total of 22 patients with chronic unexplained cough and OSA were randomized of whom18 completed 6 weeks of treatments with either CPAP or sham CPAP. The CPAP vs. sham CPAP-treated group were comparable in terms of sex distribution, body mass index, and OSA severity. Following CPAP therapy, there was a significantly greater improvement in total LCQ scores as compared to those treated with sham therapy (ANCOVA p value 0.016). No significant differences were noted in the exhaled breath condensate marker changes between CPAP-treated vs. sham CPAP-treated groups. CONCLUSION Treatment of comorbid OSA in patients with chronic cough improved cough quality of life measures following treatment of OSA with CPAP in this pilot study. Larger studies to understand this association and unravel mechanisms of CPAP benefit in chronic cough need to be undertaken. Clinical Trial Registration NCT03172130.",2020,"Following CPAP therapy, there was a significantly greater improvement in total LCQ scores as compared to those treated with sham therapy (ANCOVA p value 0.016).","['Patients with Chronic Cough and Obstructive Sleep Apnea', 'patients with chronic unexplained cough', 'chronic cough and obstructive sleep apnea (OSA', 'patients with chronic cough', '22 patients with chronic unexplained cough and OSA', 'Patients with unexplained chronic cough (>\u20092\xa0months duration of cough) and OSA']","['CPAP vs. sham CPAP', 'CPAP', 'CPAP or sham CPAP', 'CPAP or sham CPAP therapy', 'CPAP therapy']","['change in health status assessed with the Leicester Cough Questionnaire (LCQ', 'exhaled breath condensate markers of airway inflammation (interleukin-6, nitrite/nitrates, hydrogen peroxide and 8-isoprostanes', 'exhaled breath condensate marker changes', 'total LCQ scores', 'cough quality of life measures', 'sex distribution, body mass index, and OSA severity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010201', 'cui_str': 'Chronic cough'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1277590', 'cui_str': 'Unexplained cough'}, {'cui': 'C4552485', 'cui_str': 'Unexplained chronic cough'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1629517', 'cui_str': 'Exhaled breath condensate'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0295541', 'cui_str': '8-isoprostaglandin F2alpha'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036878', 'cui_str': 'Sex Distribution'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",22.0,0.0751761,"Following CPAP therapy, there was a significantly greater improvement in total LCQ scores as compared to those treated with sham therapy (ANCOVA p value 0.016).","[{'ForeName': 'Krishna M', 'Initials': 'KM', 'LastName': 'Sundar', 'Affiliation': 'Department of Medicine, University of Utah, Salt Lake City, Utah, USA. krishna.sundar@hsc.utah.edu.'}, {'ForeName': 'Alika M', 'Initials': 'AM', 'LastName': 'Willis', 'Affiliation': 'Department of Medicine, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': 'Sleep-Wake Center, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Hu', 'Affiliation': 'Family & Preventive Medicine, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Jay P', 'Initials': 'JP', 'LastName': 'Kitt', 'Affiliation': 'Department of Biomedical Informatics and Department of Chemistry, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Surinder S', 'Initials': 'SS', 'LastName': 'Birring', 'Affiliation': ""Centre for Human & Applied Physiological Sciences, School of Basic & Medical Biosciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.""}]",Lung,['10.1007/s00408-020-00354-1'] 15,32356115,Poor prognostic factors in predicting abatacept response in a phase III randomized controlled trial in psoriatic arthritis.,"In ASTRAEA (NCT01860976), abatacept significantly increased American College of Rheumatology criteria 20% (ACR20) responses at Week 24 versus placebo in patients with psoriatic arthritis (PsA). This post hoc analysis explored relationships between prospectively identified baseline characteristics [poor prognostic factors (PPFs) ] and response to abatacept. Patients were randomized (1:1) to receive subcutaneous abatacept 125 mg weekly or placebo for 24 weeks; those without ≥ 20% improvement in joint counts at Week 16 switched to open-label abatacept. Potential predictors of ACR20 response were identified by treatment arm using multivariate analyses. Likelihood of ACR20 response to abatacept versus placebo was compared in univariate and multivariate analyses in subgroups stratified by the PPF, as defined by EULAR and/or GRAPPA treatment guidelines. Odds ratios (ORs) were generated using logistic regression to identify meaningful differences (OR cut-off: 1.2). 424 patients were randomized and treated (abatacept n = 213; placebo n = 211). In abatacept-treated patients, elevated C-reactive protein (CRP), high Disease Activity Score based on 28 joints (CRP), presence of dactylitis, and ≥ 3 joint erosions were identified as predictors of response (OR > 1.2). In placebo-treated patients, only dactylitis was a potential predictor of response. In the univariate analysis stratified by PPF, ACR20 response was more likely (OR > 1.2) with abatacept versus placebo in patients with baseline PPFs than in those without; multivariate analysis confirmed this finding. Response to abatacept versus placebo is more likely in patients with features indicative of high disease activity and progressive disease; these characteristics are recognized as PPFs in treatment guidelines for PsA.",2020,"In the univariate analysis stratified by PPF, ACR20 response was more likely (OR > 1.2) with abatacept versus placebo in patients with baseline PPFs than in those without; multivariate analysis confirmed this finding.","['424 patients', 'psoriatic arthritis', 'patients with psoriatic arthritis (PsA']","['subcutaneous abatacept 125\xa0mg weekly or placebo', 'placebo']","['ACR20 response', 'elevated C-reactive protein (CRP), high Disease Activity Score based on 28 joints (CRP), presence of dactylitis, and\u2009≥\u20093 joint erosions', 'Odds ratios (ORs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1619966', 'cui_str': 'abatacept'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0742906', 'cui_str': 'Elevated C-reactive protein'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0239161', 'cui_str': 'Dactylitis'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",424.0,0.122464,"In the univariate analysis stratified by PPF, ACR20 response was more likely (OR > 1.2) with abatacept versus placebo in patients with baseline PPFs than in those without; multivariate analysis confirmed this finding.","[{'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Swedish Medical Center, University of Washington School of Medicine, Seattle, WA, USA. pmease@philipmease.com.'}, {'ForeName': 'Iain B', 'Initials': 'IB', 'LastName': 'McInnes', 'Affiliation': 'Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Strand', 'Affiliation': 'Division of Immunology and Rheumatology, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'FitzGerald', 'Affiliation': ""St. Vincent's University Hospital, The Conway Institute for Biomolecular Research, and University College Dublin, Dublin, Ireland.""}, {'ForeName': 'Harris A', 'Initials': 'HA', 'LastName': 'Ahmad', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Yedid', 'Initials': 'Y', 'LastName': 'Elbez', 'Affiliation': 'Excelya, Boulogne-Billancourt, France.'}, {'ForeName': 'Subhashis', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}]",Rheumatology international,['10.1007/s00296-020-04564-x'] 16,32356170,"A prospective, comparative study of subacromial corticosteroid injection and subacromial corticosteroid injection plus suprascapular nerve block in patients with shoulder impingement syndrome.","INTRODUCTION Efforts are recently focused on the management of shoulder impingement syndrome (SIS) with a conservative and targeted approach because of its psychosocial impact, reduction in the quality of life, the cost to the economy and its negative effect on daily activities. Therefore, many studies have been designed to evaluate and compare the effectiveness of different treatments. The main purpose of this study was to identify the effect of combination of subacromial corticosteroid injection (SCI) and suprascapular nerve block (SSNB) on shoulder impingement syndrome (SIS). MATERIALS AND METHODS 66 patients with SIS were randomly divided into two groups (33 patients per group): Group 1: SCI; Group 2: SCI plus SSNB. The estimation of the severity of pain by the visual analogue scale (VAS) and shoulder disability using quick DASH (Disabilities of the Arm, Shoulder and Hand) were assessed at baseline and 1, 3 months post-injection. RESULTS The mean age of patients was 55.55 ± 10.42 years in Group 1 and 57.24 ± 12.75 years in Group 2. In steroid group, pre- and post-treatment (at 1 and 3 months) VAS/quickDASH scores were 8.64 ± 0.99/78.03 ± 9.24, 2.09 ± 0.84/15.58 ± 7.23 and 3.06 ± 1.12/25.06 ± 8.74, respectively. In steroid plus SSNB group, pre- and post-treatment (at 1 and 3 months) VAS/quickDASH scores were 8.45 ± 0.90/75.15 ± 9.86, 1.24 ± 0.43/10.88 ± 2.14 and 1.51 ± 0.56/15.51 ± 5.04, respectively. Both treatment groups showed a significant relief of pain at 1 and 3 months post-injection (p < 0.05). However, the VAS and quickDASH scores at 1 and 3 months were significantly lower in Group 2 versus Group 1 (p < 0.05). CONCLUSION The combination of SCI and SSNB seems to produce the long-term effect in pain relief and functional improvement.",2021,"However, the VAS and quickDASH scores at 1 and 3 months were significantly lower in Group 2 versus Group 1 (p < 0.05). ","['66 patients with SIS were randomly divided into two groups (33 patients per group', 'patients with shoulder impingement syndrome', 'The mean age of patients was 55.55\u2009±\u200910.42\xa0years in Group 1 and 57.24\u2009±\u200912.75\xa0years in Group 2', 'shoulder impingement syndrome (SIS']","['SCI plus SSNB', 'subacromial corticosteroid injection and subacromial corticosteroid injection plus suprascapular nerve block', 'subacromial corticosteroid injection (SCI) and suprascapular nerve block (SSNB']","['VAS/quickDASH scores', 'severity of pain by the visual analogue scale (VAS) and shoulder disability using quick DASH (Disabilities of the Arm, Shoulder and Hand', 'relief of pain', 'pain relief and functional improvement', 'VAS and quickDASH scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376685', 'cui_str': 'Impingement syndrome of shoulder region'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517520', 'cui_str': '10.42'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0394703', 'cui_str': 'Injection of anesthetic agent into suprascapular nerve'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",66.0,0.0205467,"However, the VAS and quickDASH scores at 1 and 3 months were significantly lower in Group 2 versus Group 1 (p < 0.05). ","[{'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Kocaeli Government Hospital, Gunes Street 41300, Kocaeli, Turkey. dr.ozcanebru@gmail.com.'}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-020-03455-x'] 17,32367375,"Prospective randomized clinical trial of open operative, minimally invasive and conservative treatments of acute Achilles tendon tear.","INTRODUCTION The acute Achilles tendon rupture (AATR) is a common injury of great importance in an increasingly active society. When early functional treatment is established, recent literature shows comparable rates of re-rupture in conservative and surgical treatments of AATR. However, there is no study comparing the outcome using a dynamometer. The aim of this study is to evaluate the results of patients with AATR treated conservatively and surgically using a dynamometer. In addition, the data are compared to evaluation of the Achilles tendon with ultrasound. MATERIALS AND METHODS Between 2012 and 2015, 90 patients (mean age 41 years, male-to-female ratio 81:9) with AATR were enrolled in a prospective, randomized, and monocentric study. Thirty patients were assigned to each of the three different treatment groups. Group OPEN received a conventional open suture of the Achilles tendon, group MIN received a minimally invasive suture and patients in group CONS were treated conservatively. Follow-up treatment was the same for all patients regardless of the group they were assigned to. Plantar flexion force was assessed using a dynamometer (Biodex® System 3 Pro, Biodex Medical Systems). Further evaluation included a physical test and ultrasound of the Achilles tendon. RESULTS Sixty-nine patients were available for a 24-month follow-up. In each of the OPEN and MIN groups, there was one re-rupture. In the CONS group, there were two re-ruptures. A positive correlation between the Biodex® dynamometer measurement and the American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score (AOFAS-AH) could be found in all groups. Nevertheless, there were no significant differences between the treatment groups after 2 years. On sonography, all patients showed isolated structure loosening and a significantly thickened cross-sectional area compared with the non-injured opposite side, without differences between the groups. There was no correlation between the Biodex® measurement and sonographic outcome. CONCLUSION At 24-month follow-up, no significant difference can be found in patients with AATR treated operatively or conservatively. It is, therefore, important to inform patients with AATR regarding the respective advantages and disadvantages of the individual treatment strategies. LEVEL OF EVIDENCE Randomized controlled trial; level 1.",2021,"At 24-month follow-up, no significant difference can be found in patients with AATR treated operatively or conservatively.","['patients with AATR treated conservatively and surgically using a dynamometer', 'Between 2012 and 2015', '90 patients (mean age 41\xa0years, male-to-female ratio 81:9) with AATR', 'Sixty-nine patients', 'acute Achilles tendon tear', 'Thirty patients']","['conventional open suture of the Achilles tendon, group MIN received a minimally invasive suture and patients in group']","['Biodex® measurement and sonographic outcome', 'isolated structure loosening', 'Plantar flexion force', 'American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score (AOFAS-AH']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0277828', 'cui_str': 'Late fontanel closure'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0333050', 'cui_str': 'Loosening'}, {'cui': 'C0231784', 'cui_str': 'Plantar flexion'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0230459', 'cui_str': 'Hindfoot'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.0362527,"At 24-month follow-up, no significant difference can be found in patients with AATR treated operatively or conservatively.","[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Fischer', 'Affiliation': 'Department of Foot and Ankle Surgery, Berufsgenossenschaftliche Unfallklinik Frankfurt am Main, Friedberger Landstr. 430, 60389, Frankfurt am Main, Germany. dr.sebastian.fischer@me.com.'}, {'ForeName': 'Christin', 'Initials': 'C', 'LastName': 'Colcuc', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, Evangelical Hospital Bethel Bielefeld, Bielefeld, Germany.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Gramlich', 'Affiliation': 'Department for Trauma and Orthopaedic Surgery, Berufsgenossenschaftliche Unfallklinik Frankfurt am Main, Frankfurt am Main, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Stein', 'Affiliation': 'Department of Sporttraumatology- Knee- and Shoulder- Surgery, Berufsgenossenschaftliche Unfallklinik Frankfurt am Main, Frankfurt am Main, Germany.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Abdulazim', 'Affiliation': 'Department of Orthopedics, Universitätsspital Basel, Basel, Switzerland.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'von Welck', 'Affiliation': 'Department for Trauma and Orthopaedic Surgery, Berufsgenossenschaftliche Unfallklinik Frankfurt am Main, Frankfurt am Main, Germany.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Hoffmann', 'Affiliation': 'Department for Trauma and Orthopaedic Surgery, Berufsgenossenschaftliche Unfallklinik Frankfurt am Main, Frankfurt am Main, Germany.'}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-020-03461-z'] 18,32363910,Provider experiences with three- and six-month antiretroviral therapy dispensing for stable clients in Zambia.,"Multi-month dispensing of antiretroviral therapy (ART) has been taken to scale in many settings in sub-Saharan Africa with the benefits of improved client satisfaction and decreased client costs. Six-month ART dispensing may further increase these benefits; however, data are lacking. Within a cluster-randomized trial of three- versus six-month dispensing in Malawi and Zambia, we performed a sub-study to explore Zambian provider experiences with multi-month dispensing. We conducted 18 in-depth interviews with clinical officers and nurses dispensing ART as part of INTERVAL in Zambia. Interview questions focused on provider perceptions of client acceptability, views on client sharing and selling of ART, and perceptions on provider workload and clinic efficiency, with a focus on differences between three- and six-month dispensing. Interviews were analyzed using inductive thematic analysis to identify key themes and patterns within the data. Providers perceived significant benefits of multi-month dispensing, with advantages of six-month over three-month dispensing related to a reduced burden on clients, and for reductions in their own workload and clinic congestion. Among nearly all providers, the six-month dispensing strategy was perceived as ideal. Further research is needed to quantify clinical outcomes of six-month dispensing and feasibility of scaling-up this intervention in resource-limited settings.Clinical Trial Number: NCT03101592.",2021,"Providers perceived significant benefits of multi-month dispensing, with advantages of six-month over three-month dispensing related to a reduced burden on clients, and for reductions in their own workload and clinic congestion.","['stable clients in Zambia', '18 in-depth interviews with clinical officers and nurses dispensing ART as part of INTERVAL in Zambia']","['three- and six-month antiretroviral therapy dispensing', 'antiretroviral therapy (ART']","['client acceptability, views on client sharing and selling of ART, and perceptions on provider workload and clinic efficiency']","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0237758', 'cui_str': 'Non-commissioned officer'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",,0.0441767,"Providers perceived significant benefits of multi-month dispensing, with advantages of six-month over three-month dispensing related to a reduced burden on clients, and for reductions in their own workload and clinic congestion.","[{'ForeName': 'Khumbo', 'Initials': 'K', 'LastName': 'Phiri', 'Affiliation': 'Partners in Hope Medical Center, Lilongwe, Malawi.'}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'McBride', 'Affiliation': 'Fielding School of Public Health, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Zumbe', 'Initials': 'Z', 'LastName': 'Siwale', 'Affiliation': 'Right to Care, EQUIP, Lusaka, Zambia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Hubbard', 'Affiliation': 'Partners in Hope Medical Center, Lilongwe, Malawi.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Bardon', 'Affiliation': 'School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Corrina', 'Initials': 'C', 'LastName': 'Moucheraud', 'Affiliation': 'Fielding School of Public Health, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Mwiza', 'Initials': 'M', 'LastName': 'Haambokoma', 'Affiliation': 'Right to Care, EQUIP, Lusaka, Zambia.'}, {'ForeName': 'Pedro T', 'Initials': 'PT', 'LastName': 'Pisa', 'Affiliation': 'Right to Care, EQUIP, Centurion, South Africa.'}, {'ForeName': 'Crispin', 'Initials': 'C', 'LastName': 'Moyo', 'Affiliation': 'Right to Care, EQUIP, Lusaka, Zambia.'}, {'ForeName': 'Risa M', 'Initials': 'RM', 'LastName': 'Hoffman', 'Affiliation': 'Partners in Hope Medical Center, Lilongwe, Malawi.'}]",AIDS care,['10.1080/09540121.2020.1755010'] 19,32360007,Volatile Anesthesia Versus Total Intravenous Anesthesia During Cardiopulmonary Bypass: A Narrative Review on the Technical Challenges and Considerations.,The Mortality in Cardiac Surgery Randomized Controlled Trial of Volatile Anesthetics (MYRIAD) demonstrated that cardiac surgery with either volatile anesthesia or intravenous anesthesia techniques can be comparable with respect to morbidity and mortality. Maintaining anesthesia during cardiopulmonary bypass (CPB) with either approach requires appreciation of the nuances that are unique to each. This narrative review addresses these technical challenges and other considerations.,2020,Maintaining anesthesia during cardiopulmonary bypass (CPB) with either approach requires appreciation of the nuances that are unique to each.,['During Cardiopulmonary Bypass'],"['Volatile Anesthetics (MYRIAD', 'Volatile Anesthesia Versus Total Intravenous Anesthesia', 'cardiopulmonary bypass (CPB', 'volatile anesthesia or intravenous anesthesia techniques']",['morbidity and mortality'],"[{'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0443769', 'cui_str': 'Volatile agent'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0002920', 'cui_str': 'Intravenous anesthesia'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0190044,Maintaining anesthesia during cardiopulmonary bypass (CPB) with either approach requires appreciation of the nuances that are unique to each.,"[{'ForeName': 'Chuen Jye', 'Initials': 'CJ', 'LastName': 'Yeoh', 'Affiliation': 'Department of Anaesthesiology, Singapore General Hospital, Singapore; Department of Cardiothoracic Anaesthesia, National Heart Centre, Singapore.'}, {'ForeName': 'Nian Chih', 'Initials': 'NC', 'LastName': 'Hwang', 'Affiliation': 'Department of Anaesthesiology, Singapore General Hospital, Singapore; Department of Cardiothoracic Anaesthesia, National Heart Centre, Singapore. Electronic address: hwang.nian.chih@singhealth.com.sg.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.03.013'] 20,32367234,Is selective nerve root block necessary for learning percutaneous endoscopic lumbar discectomy: a comparative study using a cumulative summation test for learning curve.,"PURPOSE The aim of this study was to investigate the effect of lumbar spine selective nerve root block (SNRB) experience on the learning efficiency of percutaneous endoscopic lumbar discectomy (PELD) for junior trainees. METHODS A total of 480 patients undergoing single-level PELD performed by eight junior trainees were included. The trainees were divided into two groups based on whether they had previous SNRB experience (group A, yes; group B, no). Surgical proficiency was defined as total operation time less than 65 minutes and cumulative radiation exposure time no more than 40 seconds. The learning curve was analyzed by cumulative summation (CUSUM) test. Clinical evaluations included Macnab classification, visual analog scale (VAS)-low back score, VAS-leg score, and Oswestry Disability Index (ODI). Follow-up information at 12 months was also obtained. RESULTS Integral number of cases before achieving an acceptable surgical level in group A (47.75 ± 2.50 cases) was significantly smaller than that in group B (56.50 ± 1.29 cases, p < 0.05), along with less accumulated failure (18.75 ± 0.96 cases vs. 25.50 ± 1.75 cases, p < 0.05). The two groups were comparable in clinical outcomes. Forty-seven cases of complications were observed, with 17 in group A and 30 in group B (p < 0.05). CONCLUSION Previous experience of SNRB improved the performance of PELD with shorter operation time and less radiation exposure. SNRB practice may reduce the complication rate without a significant effect on the recurrence of symptoms and reoperation.",2020,"Forty-seven cases of complications were observed, with 17 in group A and 30 in group B (p < 0.05). ","['junior trainees', '480 patients undergoing single-level PELD performed by eight junior trainees were included']","['lumbar spine selective nerve root block (SNRB) experience', 'percutaneous endoscopic lumbar discectomy (PELD']","['total operation time less', 'complications', 'acceptable surgical level', 'cumulative radiation exposure time', 'complication rate', 'recurrence of symptoms and reoperation', 'Macnab classification, visual analog scale (VAS)-low back score, VAS-leg score, and Oswestry Disability Index (ODI']","[{'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0228084', 'cui_str': 'Nerve root structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}]",480.0,0.0260394,"Forty-seven cases of complications were observed, with 17 in group A and 30 in group B (p < 0.05). ","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Sun', 'Affiliation': ""Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.""}, {'ForeName': 'Huiqiao', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': ""Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.""}, {'ForeName': 'Zeng', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': ""Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.""}, {'ForeName': 'Jiajia', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': ""Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.""}, {'ForeName': 'Yunhao', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.""}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.""}, {'ForeName': 'Xiaoxiang', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': ""Department of Orthopaedics, The 455th Hospital of Chinese People's Liberation Army, Shanghai, China.""}, {'ForeName': 'Xiaolong', 'Initials': 'X', 'LastName': 'Shen', 'Affiliation': ""Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.""}, {'ForeName': 'Xiao-Dong', 'Initials': 'XD', 'LastName': 'Wu', 'Affiliation': ""Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': ""Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China. guxin2004ty@163.com.""}, {'ForeName': 'Changgui', 'Initials': 'C', 'LastName': 'Shi', 'Affiliation': ""Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China. charlieshi@smmu.edu.cn.""}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Yuan', 'Affiliation': ""Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.""}]",International orthopaedics,['10.1007/s00264-020-04558-1'] 21,32362229,Effect of Intensive Blood Pressure Lowering on the Risk of Atrial Fibrillation.,"It remains uncertain whether intensive control of blood pressure (BP) results in a lower risk of atrial fibrillation (AF) in patients with hypertension. Using data from SPRINT (Systolic Blood Pressure Intervention Trial), which enrolled participants with hypertension at increased risk of cardiovascular disease, we examined whether intensive BP lowering (target systolic BP [SBP] <120 mm Hg), compared with standard BP lowering (target SBP<140 mm Hg), results in a lower risk of AF. This analysis included 8022 participants (4003 randomized to the intensive arm and 4019 to standard BP arm) who were free of AF at the time of enrollment and with available baseline and follow-up electrocardiographic data. AF was ascertained from standard 12-lead electrocardiograms recorded at biannual study examinations and an exit visit. During up to 5.2 years of follow-up and a total of 28 322 person-years, 206 incident AF cases occurred; 88 in the intensive BP-lowering arm and 118 in the standard BP-lowering arm. Intensive BP lowering was associated with a 26% lower risk of developing new AF (hazard ratio, 0.74 [95% CI, 0.56-0.98]; P =0.037). This effect was consistent among prespecified subgroups of SPRINT participants stratified by age, sex, race, SBP tertiles, prior cardiovascular disease, and prior chronic kidney disease when interactions between treatment effect and these subgroups were assessed using Hommel adjusted P values. In conclusion, intensive treatment to a target of SBP <120 mm Hg in patients with hypertension at high risk of cardiovascular disease has the potential to reduce the risk of AF. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT01206062.",2020,"Intensive BP lowering was associated with a 26% lower risk of developing new AF (hazard ratio, 0.74 [95% CI, 0.56-0.98]; P =0.037).","['enrolled participants with hypertension at increased risk of cardiovascular disease', 'patients with hypertension', '8022 participants (4003 randomized to the intensive arm and 4019 to standard BP arm) who were free of AF at the time of enrollment and with available baseline and follow-up electrocardiographic data', 'patients with hypertension at high risk of cardiovascular disease']","['Intensive Blood Pressure Lowering', 'SBP']","['intensive BP lowering (target systolic BP [SBP', 'Intensive BP lowering', 'Risk of Atrial Fibrillation', 'blood pressure (BP']","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1277632', 'cui_str': 'Target systolic blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]",,0.199646,"Intensive BP lowering was associated with a 26% lower risk of developing new AF (hazard ratio, 0.74 [95% CI, 0.56-0.98]; P =0.037).","[{'ForeName': 'Elsayed Z', 'Initials': 'EZ', 'LastName': 'Soliman', 'Affiliation': 'From the Epidemiological Cardiology Research Center, Department of Epidemiology and Prevention, Division of Public Health Sciences and Department of Medicine, Section on Cardiology, Wake Forest School of Medicine, Winston-Salem, NC (E.Z.S.).'}, {'ForeName': 'Akm F', 'Initials': 'AF', 'LastName': 'Rahman', 'Affiliation': 'Department of Biostatistics (A.F.R.), University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Zhu-Ming', 'Initials': 'ZM', 'LastName': 'Zhang', 'Affiliation': 'Epidemiological Cardiology Research Center (EPICARE), Department of Epidemiology and Prevention, Division of Public Health Sciences (Z-M.Z.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Carlos J', 'Initials': 'CJ', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Medicine/Cardiology, Albert Einstein College of Medicine, Bronx, NY (C.J.R.).'}, {'ForeName': 'Tara I', 'Initials': 'TI', 'LastName': 'Chang', 'Affiliation': 'Division of Nephrology, Stanford University School of Medicine, Palo Alto, CA (T.I.C.).'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Bates', 'Affiliation': 'Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine, Houston, TX (J.T.B.).'}, {'ForeName': 'Lama', 'Initials': 'L', 'LastName': 'Ghazi', 'Affiliation': 'Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN (L.G.).'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Blackshear', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic Florida, Jacksonville, FL (J.L.B.).'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': 'Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, Aurora, CO (M.C.).'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Fine', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, MD (L.J.F.).'}, {'ForeName': 'Walter T', 'Initials': 'WT', 'LastName': 'Ambrosius', 'Affiliation': 'Department of Biostatistics and Data Science, Division of Public Health Sciences (W.T.A.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Cora E', 'Initials': 'CE', 'LastName': 'Lewis', 'Affiliation': 'Department of Epidemiology, and Department of Medicine (C.E.L.), University of Alabama at Birmingham, Birmingham, AL.'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.14766'] 22,32362231,Incidence and Implications of Atrial Fibrillation/Flutter in Hypertension: Insights From the SPRINT Trial.,"We evaluated the impact of intensive blood pressure control on the incidence of new-onset atrial fibrillation/flutter (AF) and the prognostic implications of preexisting and new-onset AF in SPRINT (Systolic Blood Pressure Intervention Trial) participants. New-onset AF was defined as occurrence of AF in 12-lead electrocardiograms after randomization in participants free of AF at baseline. Poisson regression modeling was used to calculate incident rates of new-onset AF. Multivariable-adjusted Cox proportional hazard models were used to evaluate the risk of adverse cardiovascular events (composite of myocardial infarction, non-myocardial infarction acute coronary syndrome, stroke, heart failure, or cardiovascular death). In 9327 participants, 8.45% had preexisting AF, and 1.65% had new-onset AF. The incidence of new-onset AF was 4.53 per 1000-person years, with similar rates in the standard and intensive treatment arms (4.95 versus 4.11 per 1000-person years; adjusted P =0.14). Participants with preexisting AF (adjusted hazard ratio, 1.83 [95% CI, 1.46-2.31]; P <0.001) and new-onset AF (adjusted hazard ratio, 2.45 [95% CI, 1.58-3.80]; P <0.001) had a greater risk for development of adverse cardiovascular events compared with those with no AF. Participants with preexisting AF who achieved blood pressure <120/80 mm Hg at 3 months continued have a poor prognosis (adjusted hazard ratio, 1.88 [95% CI, 1.32-2.70]; P =0.001) compared with those with no AF. Intensive blood pressure control does not diminish the incidence of new-onset AF in an older, high-risk, nondiabetic population. Both preexisting and new-onset AF have adverse prognostic implications. In participants with preexisting AF, residual cardiovascular risk is evident even with on-treatment blood pressure <120/80 mm Hg. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT01206062.",2020,"Participants with preexisting AF (adjusted hazard ratio, 1.83 [95% CI, 1.46-2.31]; P <0.001) and new-onset AF (adjusted hazard ratio, 2.45","['Hypertension', '9327 participants, 8.45% had preexisting AF, and 1.65% had new-onset AF']","['Intensive blood pressure control', 'intensive blood pressure control']","['incidence of new-onset AF', 'blood pressure', 'incidence of new-onset atrial fibrillation/flutter (AF', 'adverse cardiovascular events (composite of myocardial infarction, non-myocardial infarction acute coronary syndrome, stroke, heart failure, or cardiovascular death', 'adverse cardiovascular events']","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0155709', 'cui_str': 'Atrial fibrillation and flutter'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0155709', 'cui_str': 'Atrial fibrillation and flutter'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",9327.0,0.274753,"Participants with preexisting AF (adjusted hazard ratio, 1.83 [95% CI, 1.46-2.31]; P <0.001) and new-onset AF (adjusted hazard ratio, 2.45","[{'ForeName': 'Vibhu', 'Initials': 'V', 'LastName': 'Parcha', 'Affiliation': 'From the Division of Cardiovascular Disease (V.P., J.K., G.A., P.A.), University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Nirav', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'Department of Medicine (N.P.), University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Rajat', 'Initials': 'R', 'LastName': 'Kalra', 'Affiliation': 'Cardiovascular Division, University of Minnesota, Minneapolis (R.K.).'}, {'ForeName': 'Joonseok', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'From the Division of Cardiovascular Disease (V.P., J.K., G.A., P.A.), University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Orlando M', 'Initials': 'OM', 'LastName': 'Gutiérrez', 'Affiliation': 'Division of Nephrology, Department of Medicine (O.M.G.), University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Garima', 'Initials': 'G', 'LastName': 'Arora', 'Affiliation': 'From the Division of Cardiovascular Disease (V.P., J.K., G.A., P.A.), University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Arora', 'Affiliation': 'From the Division of Cardiovascular Disease (V.P., J.K., G.A., P.A.), University of Alabama at Birmingham, Birmingham.'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.14690'] 23,32303763,Acute cognitive effects of the hypocretin receptor antagonist almorexant relative to zolpidem and placebo: a randomized clinical trial.,"STUDY OBJECTIVES Hypnotic medications can adversely affect behavior during unanticipated awakenings during the night. Animals treated with the hypocretin (Hcrt) receptor antagonist almorexant (ALM) have less acute cognitive impairment compared to the GABAA receptor modulator zolpidem (ZOL). This study aimed to determine whether ALM produces less acute cognitive impairment than ZOL in human subjects. METHODS Healthy, young adult, unmedicated male and female subjects participated in a controlled trial of a single dose of ALM 100 mg (N = 48), ALM 200 mg (N = 53), ZOL 10 mg (N = 49), and placebo (PBO, N = 52). RESULTS ZOL and both doses of ALM produced similar levels of subjective sleepiness and impaired the ability of subjects to remain awake in a dark, low-stimulus setting relative to PBO. For most cognitive measures, performance under ZOL was significantly worse than ALM or PBO. For tasks involving verbal memory or visual-motor coordination, ZOL impaired performance, whereas the two doses of ALM were no different than PBO. For tasks involving higher-order executive function, ZOL produced impairment in processing speed and inhibitory control, whereas the two doses of ALM were no different than PBO. Performance decrements for ALM were less than ZOL but greater than PBO for some reaction time measures. CONCLUSIONS The data provide support for the hypothesis that Hcrt receptor antagonists produce less functional impairment than a benzodiazepine receptor agonist (BzRA). These observations are particularly relevant to patients treated with sedative-hypnotics who are at elevated risk for falls and other untoward events during the intended hours for sleep.",2020,"For tasks involving higher order executive function, ZOL produced impairment in processing speed and inhibitory control, whereas the 2 doses of ALM were no different than PBO.","['human subjects', 'Healthy, young adult, unmedicated male and female subjects']","['ALM', 'placebo', 'hypocretin receptor antagonist almorexant (ALM', 'Zolpidem and Placebo', 'ZOL']","['Performance decrements for ALM', 'subjective sleepiness', 'acute cognitive impairment']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1871407', 'cui_str': 'almorexant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1113688', 'cui_str': 'Orexin'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C0078839', 'cui_str': 'zolpidem'}]","[{'cui': 'C1871407', 'cui_str': 'almorexant'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]",,0.0357918,"For tasks involving higher order executive function, ZOL produced impairment in processing speed and inhibitory control, whereas the 2 doses of ALM were no different than PBO.","[{'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Neylan', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Richards', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Metzler', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Leslie M', 'Initials': 'LM', 'LastName': 'Ruoff', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Varbel', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Aoife', 'Initials': 'A', 'LastName': ""O'Donovan"", 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Sivasubramanian', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Motraghi', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hlavin', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Batki', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Sabra S', 'Initials': 'SS', 'LastName': 'Inslicht', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Samuelson', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Morairty', 'Affiliation': 'Center for Neuroscience, Biosciences Division, SRI International, Menlo Park, CA.'}, {'ForeName': 'Thomas S', 'Initials': 'TS', 'LastName': 'Kilduff', 'Affiliation': 'Center for Neuroscience, Biosciences Division, SRI International, Menlo Park, CA.'}]",Sleep,['10.1093/sleep/zsaa080'] 24,32360848,"Bond assessment of resin modified glass ionomer cement to dentin conditioned with photosensitizers, laser and conventional regimes.","AIM To assess different conditioning regimes on shear bond strength (SBS) of resin modified glass ionomer cement (RMGIC) bonded to dentin MATERIAL AND METHODS: Fifty non carious intact maxillary molars were cleaned, isolated and randomly divided into five groups (n = 10). Before randomization, dentin surface was exposed and finished. Samples in group 1 were conditioned with methylene blue photosensitizer (MBP) 50 mg/l and activated by photodynamic therapy (PDT), Group 2: surface treated with Er,Cr:YSGG (ECL), Group 3: surface conditioned with polyacrylic acid (PAA) (control), Group 4: surface conditioned with 17 % Ethylenediaminetetraacetic acid (EDTA), Group 5: surface conditioned with total etch (Optibond solo Plus). For SBS testing the samples were placed in universal testing machine. Fracture analysis of debonded surfaces were evaluated using stereomicroscope at 40x magnification. Means and standard deviations were calculated using analysis of variance (ANOVA) and Tukey's post hoc test at a significance level of (p < 0.05). RESULTS The maximum bond strength was found in group 5 conditioned with Optibond solo plus total etch (23.15 ± 3.21 MPa). Whereas, the lowest bond values were observed in group 1 treated with MBP (15.25 ± 1.54 MPa). Moreover, samples in group 2, group 3 and group 4 resulted in comparable bond strength (p > 0.05). CONCLUSION MBP at 50 mg/l is not recommended to condition dentin prior to RMGIC application. Moreover, ECL has a potential to be suggested for dentin conditioning compared to PAA.",2020,"Moreover, samples in group 2, group 3 and group 4 resulted in comparable bond strength (p > 0.05) CONCLUSION: MBP at 50 mg/",['Fifty non carious intact maxillary molars'],"['photodynamic therapy (PDT), Group 2: surface treated with Er,Cr:YSGG (ECL), Group 3: surface conditioned with polyacrylic acid (PAA) (control), Group 4: surface conditioned with 17% Ethylenediaminetetraacetic acid (EDTA), Group 5: surface conditioned with total etch (Optibond solo Plus', 'ECL', 'methylene blue photosensitizer (MBP) 50', 'MBP']","['maximum bond strength', 'shear bond strength (SBS', 'lowest bond values', 'bond strength']","[{'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0054720', 'cui_str': 'Carbomer-940'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0013618', 'cui_str': 'Edetic Acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1121655', 'cui_str': 'OptiBond Solo Plus'}, {'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C0162713', 'cui_str': 'Photosensitizing agent'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",50.0,0.0255986,"Moreover, samples in group 2, group 3 and group 4 resulted in comparable bond strength (p > 0.05) CONCLUSION: MBP at 50 mg/","[{'ForeName': 'Abdulaziz Abdullah', 'Initials': 'AA', 'LastName': 'Al-Khureif', 'Affiliation': 'Dental Health Department, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia. Electronic address: aalkhuraif@ksu.edu.sa.'}, {'ForeName': 'Badreldin A', 'Initials': 'BA', 'LastName': 'Mohamed', 'Affiliation': 'Community Health Department, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia. Electronic address: badreldinmoah@gmail.com.'}, {'ForeName': 'Abdullah M', 'Initials': 'AM', 'LastName': 'Al-Shehri', 'Affiliation': 'Dental Health Department, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia. Electronic address: abdullahalshehri466@gmail.com.'}, {'ForeName': 'Aftab Ahmed', 'Initials': 'AA', 'LastName': 'Khan', 'Affiliation': 'Dental Biomaterials Research Chair, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia. Electronic address: aakjk@hotmail.com.'}, {'ForeName': 'Darshan Devang', 'Initials': 'DD', 'LastName': 'Divakar', 'Affiliation': 'Dental Biomaterials Research Chair, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia. Electronic address: dardevdiv@gmail.com.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101795'] 25,32364091,The effects of pre-sleep consumption of casein protein on next-morning measures of RMR and appetite compared between sedentary pre- and postmenopausal women.,"The purpose of the present study was to compare next-morning responses of RMR and appetite to pre-sleep consumption of casein protein (CP) in pre- and postmenopausal women. The study was a randomised, crossover, double-blind, placebo-controlled trial. Seven sedentary premenopausal (age: 19·9 (sd 1·2) years; BMI: 23·1 (sd 2·6) kg/m2) and seven sedentary postmenopausal (age: 56·4 (sd 4·9) years; BMI: 26·3 (sd 3·5) kg/m2) women participated. During visit one, anthropometrics and body composition were measured. Following visit one, subjects consumed either CP (25 g) or placebo (PL) ≥2 h after their last meal and ≤30 min prior to sleep on the night before visits two and three. Visits two and three occurred ≥1 week after visit one and were 48 h apart. During visits two and three, RMR (VO2), RER and appetite were measured via indirect calorimetry and visual analogue scale, respectively. Anthropometrics and body composition were analysed by one-way ANOVA. RMR and measures of appetite were analysed using a 2 × 2 (menopause status × CP/PL) repeated-measures ANOVA. Significance was accepted at P ≤ 0·05. RMR was significantly lower in postmenopausal compared with premenopausal women under both conditions (P = 0·003). When consumed pre-sleep CP did not alter RMR, RER or appetite compared with PL when assessed next morning in pre- and postmenopausal women. These data contribute to growing evidence that pre-sleep consumption of protein is not harmful to next-morning metabolism or appetite. In addition, these data demonstrate that menopause may not alter next-morning RMR, RER or appetite after pre-sleep consumption of CP.",2021,RMR was significantly lower in postmenopausal compared to premenopausal women under both conditions (p=0.003).,"['pre and postmenopausal women', 'Seven sedentary premenopausal (age: 19.9 (SD 1.2) years', 'BMI: 23.1(SD 2.6) kg/m2) and seven sedentary postmenopausal (age: 56.4 (SD 4.9) years, BMI: 26.3 (SD 3.5) kg/m2) women participated']","['resting metabolic rate (RMR) and appetite to pre-sleep consumption of casein protein (CP', 'CP', 'placebo (PL', 'placebo']","['RMR and measures of appetite', 'RMR, RER, or appetite', 'RMR', 'next-morning RMR, RER, or appetite', 'Anthropometrics and body composition', 'RMR (VO2), respiratory exchange ratio (RER), and appetite were measured via indirect calorimetry and visual analogue scale']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C4517668', 'cui_str': '26.3'}, {'cui': 'C3844010', 'cui_str': '3.5'}]","[{'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0006781', 'cui_str': 'Indirect calorimetry'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",7.0,0.0685866,RMR was significantly lower in postmenopausal compared to premenopausal women under both conditions (p=0.003).,"[{'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Schattinger', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, The Florida State University, Tallahassee, FL32306, USA.'}, {'ForeName': 'J T', 'Initials': 'JT', 'LastName': 'Leonard', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, The Florida State University, Tallahassee, FL32306, USA.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Pappas', 'Affiliation': 'Capital Regional Medical Care, Tallahassee, FL32312, USA.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Ormsbee', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, The Florida State University, Tallahassee, FL32306, USA.'}, {'ForeName': 'L B', 'Initials': 'LB', 'LastName': 'Panton', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, The Florida State University, Tallahassee, FL32306, USA.'}]",The British journal of nutrition,['10.1017/S0007114520001506'] 26,32370545,Effects of pain neuroscience education and dry needling for the management of patients with chronic myofascial neck pain: a randomized clinical trial.,"OBJECTIVES The aim of this study was to observe the medium-term effects on pain, disability, and psychological factors of a combination of myofascial trigger point (MTrP) dry needling (DN) with pain neuroscience education (PNE) versus DN alone versus control care as usual (CUC) in patients with chronic neck pain. METHODS A total of 60 patients were randomly selected in a Spanish National Health Service Public Hospital and divided into three groups: 6 sessions of DN with 3 sessions of PNE (TrPDN + PNE group, n = 21), 6 sessions of DN alone (TrPDN group, n = 20), or 10 sessions of usual care (CUC group, n = 19). The primary outcome was neck pain intensity, while neck disability, medication intake, and psychological factors were secondary outcomes. These variables were measured at baseline, post-treatment, and at 1 month and 3 months after treatment. RESULTS TrPDN + PNE and DN alone were associated with greater reductions in pain intensity and disability compared to CUC (p < 0.01). TrPDN + PNE resulted in greater improvements in kinesiophobia, pain anxiety, and pain-related beliefs than DN alone and CUC (p < 0.01). No differences between groups were observed in medication intake, quality of life, catastrophizing, depression, or fear of pain (p > 0.05). DISCUSSION Provision of PNE and DN in the management of chronic neck pain in a Spanish National Health Service Public Hospital was associated with greater improvements in psychological factors than DN therapy only. CONCLUSION DN alone was more effective at reducing chronic non-specific neck pain and disability than CUC at 3-month follow-up. However, the inclusion of PNE combined with DN resulted in greater improvements in kinesiophobia, pain anxiety, and pain-related beliefs. TRIAL REGISTRATION NUMBER NCT03095365 (ClinicalTrials.gov).",2021,"No differences between groups were observed in medication intake, quality of life, catastrophizing, depression, or fear of pain (p > 0.05). ","['patients with chronic myofascial neck pain', '60 patients were randomly selected in a Spanish National Health Service Public Hospital', 'patients with chronic neck pain']","['pain neuroscience education and dry needling', 'PNE (TrPDN\u2009+\u2009PNE group, n\u2009=\u200921), 6 sessions of DN alone (TrPDN group, n\u2009=\u200920), or 10 sessions of usual care (CUC', 'myofascial trigger point (MTrP) dry needling (DN) with pain neuroscience education (PNE) versus DN alone versus control care as usual (CUC', 'PNE', 'TrPDN\u2009', 'PNE and DN']","['medication intake, quality of life, catastrophizing, depression, or fear of pain', 'pain, disability, and psychological factors', 'kinesiophobia, pain anxiety, and pain-related beliefs', 'pain intensity and disability', 'chronic non-specific neck pain and disability', 'neck pain intensity, while neck disability, medication intake, and psychological factors']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C3805213', 'cui_str': 'Myofascial neck pain'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0150375', 'cui_str': 'Group education'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0233702', 'cui_str': 'Algophobia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0033898', 'cui_str': 'Factors, Psychological'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}]",60.0,0.129198,"No differences between groups were observed in medication intake, quality of life, catastrophizing, depression, or fear of pain (p > 0.05). ","[{'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Valiente-Castrillo', 'Affiliation': 'Physical Therapy Unit, Rehabilitation Service, Hospital Universitario Infanta Sofía, San Sebastián de los Reyes, Spain.'}, {'ForeName': 'Aitor', 'Initials': 'A', 'LastName': 'Martín-Pintado-Zugasti', 'Affiliation': 'Department of Physiotherapy, Facultad de Medicina, Universidad San Pablo-CEU, Boadilla del Monte, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Calvo-Lobo', 'Affiliation': 'Faculty of Nursing, Physiotherapy and Podiatry, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Beltran-Alacreu', 'Affiliation': 'Department of Physiotherapy, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Josué', 'Initials': 'J', 'LastName': 'Fernández-Carnero', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, Alcorcón, Spain.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1177/0964528420920300'] 27,32371165,Safety and Efficacy of Tumor Necrosis Factor Antagonists in Older Patients With Ulcerative Colitis: Patient-Level Pooled Analysis of Data From Randomized Trials.,"BACKGROUND & AIMS Treatment of older patients (more than 60 years) with ulcerative colitis (UC) can be a challenge, because they might be more vulnerable to adverse events (AEs). We determined the effects of age on the safety and efficacy of anti-tumor necrosis factor (TNF) therapy in a pooled analysis of data from randomized trials. METHODS We obtained individual patient-level data from 4 trials of anti-TNF therapy for patients with UC from the Yale Open Data Access Project. Participants were assigned to groups of older age (60 years or older) and younger age (younger than 60 years). The primary outcome was difference in serious AEs (SAEs), defined as death, life-threatening event, hospitalization, and/or significant disability. Secondary outcomes were severe infections, non-severe infections, neoplasms, and achievement of clinical remission, defined by trial investigators as Mayo score ≤ 2 with no sub-score >1 at the end of induction or maintenance therapy. A random effects logistic regression model was fitted to estimate the effect of anti-TNF therapy on safety and efficacy by age, adjusting for confounders and trial-level effects. RESULTS The study cohort included 2257 patients (231 60 years or older). Higher proportions of older patients receiving anti-TNF therapy had SAEs (20%) and hospitalizations (14.4%), compared with younger patients (10.2% had SAEs and 5.2% were hospitalized); there were no significant differences between groups in proportions with severe or non-severe infections. Compared with placebo, there was no significant difference in safety risks associated with anti-TNF therapy (SAEs reduced by 5.4% in older patients vs reduction of 2.4% in younger patients; hospitalizations reduced by 6.7% in older patients vs reduction of 2.5% in younger patients; severe infections reduced by 3.1% vs increase of 0.7% in younger patients). There was no significant difference in between older vs younger patients in efficacy of anti-TNF therapy in inducing remission (odds risk ratio, 1.05, 95% CI, 0.33-3.39) or in maintaining remission (odds risk ratio, 0.49; 95% CI, 0.18-1.33). CONCLUSIONS In a pooled analysis of data from randomized trials, we found that older patients with UC have an increased baseline increased risk of SAEs, but no increase in risk can be attributed to anti-TNF therapy in older vs younger patients.",2021,"There was no significant difference in between older vs younger patients in efficacy of anti-TNF therapy in inducing remission (odds risk ratio, 1.05, 95% CI, 0.33-3.39) or in maintaining remission (odds risk ratio, 0.49; 95% CI, 0.18-1.33). ","['Participants were assigned to groups of older age (60 years or older) and younger age (younger than 60 years', 'Older Patients', 'patients with UC from the Yale Open Data Access Project', '2257 patients (231 60 years or older', 'older patients with UC', 'older patients (more than 60 years) with ulcerative colitis (UC', 'With Ulcerative Colitis']","['anti-TNF therapy', 'Tumor Necrosis Factor Antagonists', 'anti-tumor necrosis factor (TNF) therapy', 'placebo']","['proportions with severe or non-severe infections', 'severe infections, non-severe infections, neoplasms, and achievement of clinical remission, defined by trial investigators as Mayo score ≤ 2 with no sub-score >1 at the end of induction or maintenance therapy', 'severe infections', 'risk of SAEs', 'serious AEs (SAEs), defined as death, life-threatening event, hospitalization, and/or significant disability', 'safety and efficacy', 'safety risks associated with anti-TNF therapy (SAEs']","[{'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0439093', 'cui_str': '>'}]","[{'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3537192', 'cui_str': 'TNF Antagonists'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",2257.0,0.224528,"There was no significant difference in between older vs younger patients in efficacy of anti-TNF therapy in inducing remission (odds risk ratio, 1.05, 95% CI, 0.33-3.39) or in maintaining remission (odds risk ratio, 0.49; 95% CI, 0.18-1.33). ","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cheng', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, Massachusetts; Massachusetts General Hospital, Division of Gastroenterology, Boston, Massachusetts.'}, {'ForeName': 'Kelly C', 'Initials': 'KC', 'LastName': 'Cushing', 'Affiliation': 'Massachusetts General Hospital, Division of Gastroenterology, Boston, Massachusetts; Harvard University, Boston, Massachusetts; University of Michigan, Division of Gastroenterology, Ann Arbor, Michigan.'}, {'ForeName': 'Tianxi', 'Initials': 'T', 'LastName': 'Cai', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, Massachusetts; Massachusetts General Hospital, Division of Gastroenterology, Boston, Massachusetts.'}, {'ForeName': 'Ashwin N', 'Initials': 'AN', 'LastName': 'Ananthakrishnan', 'Affiliation': 'Massachusetts General Hospital, Division of Gastroenterology, Boston, Massachusetts; Harvard University, Boston, Massachusetts. Electronic address: aananthakrishnan@mgh.harvard.edu.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.04.070'] 28,32379107,Effects of Auricular Acupressure in Patients on Hemodialysis.,"BACKGROUND Although studies on the effectiveness of self-management in limiting fluid intake in patients on hemodialysis have been conducted extensively, xerostomia, which is a powerful stimulus of fluid intake, has received scarce attention. PURPOSE The purpose of this study was to examine the effects of a 4-week auricular acupressure treatment on xerostomia, salivary flow rate, interdialytic weight gain, constipation, and diet-related quality of life in patients on hemodialysis in Korea. METHODS This was a randomized controlled trial. Sixty patients on hemodialysis were randomly assigned to either the experimental group (n = 30) or the control group (n = 30). The experimental group received an auricular acupressure intervention, which included the application of skin tape with a Semen vaccariae seed on the five auricular acupoints, including the large intestine (CO7), San Jiao (CO17), middle triangular fossa (TF3), spleen (CO13), and upper tragus (TG1), for 4 weeks. The control group received only the application of skin tape without a seed on the same auricular acupoints for the same period. The outcome variables were as follows: xerostomia, measured using the visual analog scale; salivary flow rate, measured using the unstimulated whole saliva absorbed in oral cotton; interdialytic weight gain; the constipation assessment scale score; and the Quality of Life Related to Dietary Change Questionnaire results. RESULTS The experimental group scored significantly better than the control group in terms of xerostomia (p = .004), salivary flow rate (p = .010), constipation (p = .009), and diet-related quality of life (p < .001). CONCLUSIONS/IMPLICATIONS FOR PRACTICE Auricular acupressure may be an important tool for alleviating the negative symptoms of xerostomia and for improving quality of life in patients on hemodialysis. Nurses caring for patients on hemodialysis with both xerostomia and constipation may teach auricular acupressure to help patients self-manage their discomfort.",2020,"The experimental group scored significantly better than the control group in terms of xerostomia (p = .004), salivary flow rate (p = .010), constipation (p = .009), and diet-related quality of life (p < .001). ","['Patients on Hemodialysis', 'Sixty patients on hemodialysis', 'Nurses caring for patients on hemodialysis with both xerostomia and constipation', 'patients on hemodialysis in Korea', 'patients on hemodialysis']","['skin tape without a seed on the same auricular acupoints', 'auricular acupressure treatment', 'Auricular Acupressure', 'auricular acupressure intervention, which included the application of skin tape with a Semen vaccariae seed on the five auricular acupoints, including the large intestine (CO7), San Jiao (CO17), middle triangular fossa (TF3), spleen (CO13), and upper tragus (TG1']","['visual analog scale; salivary flow rate', 'diet-related quality of life', 'constipation assessment scale score; and the Quality of Life Related to Dietary Change Questionnaire results', 'constipation', 'xerostomia, salivary flow rate, interdialytic weight gain, constipation, and diet-related quality of life', 'salivary flow rate', 'xerostomia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0022771', 'cui_str': 'Korea'}]","[{'cui': 'C1721087', 'cui_str': 'Skin Tape'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0021851', 'cui_str': 'Structure of large intestine'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205119', 'cui_str': 'Triangular'}, {'cui': 'C0325079', 'cui_str': 'Cryptoprocta ferox'}, {'cui': 'C0037993', 'cui_str': 'Splenic structure'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0229312', 'cui_str': 'Tragus structure'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0429177', 'cui_str': 'Salivary flow rate'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",60.0,0.0268171,"The experimental group scored significantly better than the control group in terms of xerostomia (p = .004), salivary flow rate (p = .010), constipation (p = .009), and diet-related quality of life (p < .001). ","[{'ForeName': 'Eun Sook', 'Initials': 'ES', 'LastName': 'Jung', 'Affiliation': 'MSN, RN, Graduate School, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Ae Kyung', 'Initials': 'AK', 'LastName': 'Chang', 'Affiliation': 'PhD, RN, Associate Professor, College of Nursing Science & East-West Nursing Research Institute, Kyung Hee University, Seoul, Republic of Korea.'}]",The journal of nursing research : JNR,['10.1097/jnr.0000000000000378'] 29,32375501,"The effect of two types of minimal acupuncture on stooling, sleeping and feeding in infants with colic: secondary analysis of a multicentre RCT in Sweden (ACU-COL).","BACKGROUND Evidence for the effect of minimal acupuncture in infants with colic is limited. AIM To compare the effect of standardized minimal acupuncture, individualized acupuncture (where traditional acupuncture points were chosen according to the infant's symptoms) and no acupuncture on objective measures of stooling, feeding and sleeping in infants with colic (based on diaries) and perceived changes in these parameters (based on parental questionnaires). METHODS This was a secondary analysis of a multicentre randomized controlled three-armed trial conducted in four counties in Sweden between January 2013 and May 2015 (ACU-COL). The effect on crying has already been published and showed a decrease in crying time for the acupuncture groups. Infants, 2-8 weeks old, who cried and fussed for more than 3 h/day for more than 3 days/week, and thereby fulfilled the criteria for infantile colic, received four extra visits to their ordinary child health centre. The infants (n = 147) were randomly allocated via a computer-generated list to standardized minimal acupuncture at LI4 for 5 s (group A, n = 48), semi-standardized individual acupuncture with a maximum of five insertions for up to 30 s (group B, n = 49), or no acupuncture (group C, n = 48). The parents and the ordinary staff were blinded. Data were collected using: (1) diaries at baseline, during the two intervention weeks and 1-week follow-up; and (2) questionnaires with quantitative and qualitative components used at the second and fourth visits and during a follow-up telephone call. Outcomes were the changes in frequency of stooling and in hours of sleep per day. RESULTS There were no differences between groups for stooling, feeding, or sleeping at any time point according to data from the diaries. At the follow-up phone call, more parents in groups A and B (compared to group C) perceived that feeding and sleep had changed and that the symptoms of colic had improved.",2021,"At the follow-up phone call, more parents in groups A and B (compared to group C) perceived that feeding and sleep had changed and that the symptoms of colic had improved.","['infants with colic', 'infants with colic (based on diaries', 'Infants, 2-8 weeks old, who cried and fussed for more than 3 h/day for more than 3 days/week, and thereby fulfilled the criteria for infantile colic, received four extra visits to their ordinary child health centre', 'infants (n\u2009=\u2009147', 'Sweden (ACU-COL', 'four counties in Sweden between January 2013 and May 2015 (ACU-COL']","['standardized minimal acupuncture, individualized acupuncture', 'computer-generated list to standardized minimal acupuncture at LI4 for 5 s (group A, n\u2009=\u200948), semi-standardized individual acupuncture with a maximum of five insertions for up to 30 s (group B, n\u2009=\u200949), or no acupuncture', 'minimal acupuncture']","['crying time', 'stooling, feeding, or sleeping', 'frequency of stooling and in hours of sleep per day', 'stooling, sleeping and feeding']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0232488', 'cui_str': 'Abdominal colic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0677547', 'cui_str': 'days/week'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0266836', 'cui_str': 'Infantile colic'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0009413', 'cui_str': 'Colostrum'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0450480', 'cui_str': 'LI4'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0426642', 'cui_str': 'Frequency of bowel action'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0439505', 'cui_str': '/day'}]",,0.212405,"At the follow-up phone call, more parents in groups A and B (compared to group C) perceived that feeding and sleep had changed and that the symptoms of colic had improved.","[{'ForeName': 'Kajsa', 'Initials': 'K', 'LastName': 'Landgren', 'Affiliation': 'Department of Health Sciences, Faculty of Medicine, 5193Lund University, Lund, Sweden.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Hallström', 'Affiliation': 'Department of Health Sciences, Faculty of Medicine, 5193Lund University, Lund, Sweden.'}, {'ForeName': 'Iren', 'Initials': 'I', 'LastName': 'Tiberg', 'Affiliation': 'Department of Health Sciences, Faculty of Medicine, 5193Lund University, Lund, Sweden.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1177/0964528420920308'] 30,32377783,Effectiveness of different doses and routes of administration of tranexamic acid for total hip replacement.,"PURPOSE The aim of the study is to show the therapeutic efficacy, safety, and cost-benefit of using tranexamic acid (TXA), as well as the superiority of the route of administration and amount of dose in primary cementless total hip replacement (THR). METHODS In this prospective, randomized, double-blind study, we divided 200 patients into five groups of 40 patients each. The placebo group did not receive TXA. Three groups received 2 g TXA each (intravenous, topical, and combined intravenous + topical), while the fifth, combined + group, received 4 g TXA. Total blood loss was calculated, number of transfusions and thromboembolic vascular incidents were monitored, and a cost-benefit analysis of the use of TXA was performed. RESULTS Regardless of the route of administration, TXA statistically significantly reduced total blood loss (p = 0.000) and the need for transfusion (p = 0.000) compared with placebo. Total blood loss and the need for allogenic blood transfusion were statistically significantly reduced in the combined + group compared with placebo, and also compared with all other groups. Post-operative thromboembolic vascular incidents were not reported. The cost-benefit of using TXA in THR is associated with reduction of transfusion costs. CONCLUSIONS None of the TXA administration routes are superior to others, but multiple doses could statistically significantly reduce blood loss and transfusion requirements, which should be the subject of future researches.",2021,"Total blood loss and the need for allogenic blood transfusion were statistically significantly reduced in the combined + group compared with placebo, and also compared with all other groups.","['divided 200 patients into five groups of 40 patients each', 'total hip replacement', 'primary cementless total hip replacement (THR']","['tranexamic acid (TXA', 'TXA', '2\xa0g TXA each (intravenous, topical, and combined intravenous + topical), while the fifth, combined + group, received 4\xa0g TXA', 'tranexamic acid', 'placebo']","['total blood loss', 'number of transfusions and thromboembolic vascular incidents', 'therapeutic efficacy, safety, and cost-benefit', 'Total blood loss', 'need for transfusion', 'blood loss and transfusion requirements', 'Total blood loss and the need for allogenic blood transfusion']","[{'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010187', 'cui_str': 'Benefits and Costs'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C3160876', 'cui_str': 'Allogenic blood transfusion'}]",200.0,0.122808,"Total blood loss and the need for allogenic blood transfusion were statistically significantly reduced in the combined + group compared with placebo, and also compared with all other groups.","[{'ForeName': 'Stanislav', 'Initials': 'S', 'LastName': 'Palija', 'Affiliation': 'Orthopedic Department, Institute for Physical Medicine and Rehabilitation ""Dr Miroslav Zotovic"", Slatinska 11, 78000, Banja Luka, Bosnia and Herzegovina. stanislav.palija@gmail.com.'}, {'ForeName': 'Sinisa', 'Initials': 'S', 'LastName': 'Bijeljac', 'Affiliation': 'Orthopedic Department, Institute for Physical Medicine and Rehabilitation ""Dr Miroslav Zotovic"", Slatinska 11, 78000, Banja Luka, Bosnia and Herzegovina.'}, {'ForeName': 'Slavko', 'Initials': 'S', 'LastName': 'Manojlovic', 'Affiliation': 'Medical Faculty, Department of Surgery, University of Banja Luka, Banja Luka, Bosnia and Herzegovina.'}, {'ForeName': 'Zeljko', 'Initials': 'Z', 'LastName': 'Jovicic', 'Affiliation': 'Orthopedic Department, Institute for Physical Medicine and Rehabilitation ""Dr Miroslav Zotovic"", Slatinska 11, 78000, Banja Luka, Bosnia and Herzegovina.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Jovanovic', 'Affiliation': 'Orthopedic Department, Institute for Physical Medicine and Rehabilitation ""Dr Miroslav Zotovic"", Slatinska 11, 78000, Banja Luka, Bosnia and Herzegovina.'}, {'ForeName': 'Petar', 'Initials': 'P', 'LastName': 'Cvijic', 'Affiliation': 'Orthopedic Department, Institute for Physical Medicine and Rehabilitation ""Dr Miroslav Zotovic"", Slatinska 11, 78000, Banja Luka, Bosnia and Herzegovina.'}, {'ForeName': 'Dragana', 'Initials': 'D', 'LastName': 'Dragicevic-Cvjetkovic', 'Affiliation': 'Orthopedic Department, Institute for Physical Medicine and Rehabilitation ""Dr Miroslav Zotovic"", Slatinska 11, 78000, Banja Luka, Bosnia and Herzegovina.'}]",International orthopaedics,['10.1007/s00264-020-04585-y'] 31,32376313,A prospective randomized controlled trial comparing two different treatments of intrauterine adhesions.,"RESEARCH QUESTION Intrauterine adhesions (IUA) are primarily caused by trauma to the endometrium, and hysteroscopy is presently the main treatment for IUA. However, high rates of post-operative adhesion re-formation remain a problem. In this study, the combination of an intrauterine device (IUD) with a Foley catheter and the balloon uterine stent were investigated to evaluate their efficacy in preventing adhesion re-formation and the subsequent reproductive outcomes in patients with moderate to severe adhesions. DESIGN A prospective randomized controlled study was conducted in a university-affiliated hospital. A total of 171 women with Asherman's syndrome were initially recruited between August 2016 and December 2017 and were randomized to undergo either balloon uterine stent insertion or placement of a contraceptive IUD plus a Foley catheter after hysteroscopic adhesiolysis. Reduction of adhesion scores, incidence of adhesion re-formation, changes in menstrual flow and reproductive outcomes were analysed. RESULTS A total of 118 participants were eligible for analysis. The American Fertility Society (AFS) scores were not significantly different between groups before hysteroscopic adhesiolysis. At the second-look hysteroscopy, the AFS scores and adhesion recurrence rates were significantly higher in the balloon uterine stent group compared with the combination group (P < 0.01 and P = 0.024, respectively). There were no statistically significant differences in pregnancy and live birth rates between the two groups. CONCLUSIONS The combination of an IUD and a Foley balloon catheter had better efficacy in preventing adhesion re-formation than the balloon uterine stent alone; however, it did not produce better reproductive outcomes.",2020,"At the second-look hysteroscopy, the AFS scores and adhesion recurrence rates were significantly higher in the balloon uterine stent group compared with the combination group (P < 0.01 and P = 0.024, respectively).","[""171 women with Asherman's syndrome were initially recruited between August 2016 and December 2017"", 'patients with moderate to severe adhesions', 'university-affiliated hospital', '118 participants were eligible for analysis']","['balloon uterine stent insertion or placement of a contraceptive IUD plus a Foley catheter', 'Foley balloon catheter', 'intrauterine device (IUD) with a Foley catheter and the balloon uterine stent']","['AFS scores and adhesion recurrence rates', 'American Fertility Society (AFS) scores', 'pregnancy and live birth rates', 'Reduction of adhesion scores, incidence of adhesion re-formation, changes in menstrual flow and reproductive outcomes']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0156372', 'cui_str': 'Asherman syndrome'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0522776', 'cui_str': 'Placement of stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0441127', 'cui_str': 'Balloon dilatation catheter'}, {'cui': 'C0038257', 'cui_str': 'Stent'}]","[{'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",171.0,0.291661,"At the second-look hysteroscopy, the AFS scores and adhesion recurrence rates were significantly higher in the balloon uterine stent group compared with the combination group (P < 0.01 and P = 0.024, respectively).","[{'ForeName': 'Xiao-Wan', 'Initials': 'XW', 'LastName': 'Huang', 'Affiliation': 'Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Zhejiang Wenzhou 325000, PR China.'}, {'ForeName': 'Meng-Meng', 'Initials': 'MM', 'LastName': 'Lin', 'Affiliation': 'Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Zhejiang Wenzhou 325000, PR China.'}, {'ForeName': 'Hong-Qin', 'Initials': 'HQ', 'LastName': 'Zhao', 'Affiliation': 'Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Zhejiang Wenzhou 325000, PR China.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Powell', 'Affiliation': 'Nottingham University Affiliated Hospital, Nottingham Treatment Centre, Nottingham NG7 2FT, UK.'}, {'ForeName': 'Yuan-Qiu', 'Initials': 'YQ', 'LastName': 'Wang', 'Affiliation': 'Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Zhejiang Wenzhou 325000, PR China.'}, {'ForeName': 'Ru-Ru', 'Initials': 'RR', 'LastName': 'Zheng', 'Affiliation': 'Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Zhejiang Wenzhou 325000, PR China.'}, {'ForeName': 'Laura Burney', 'Initials': 'LB', 'LastName': 'Ellis', 'Affiliation': 'Lister Hospital, Stevenage, Chelsea Bridge Road, London SW1W8RH, UK.'}, {'ForeName': 'Wei-Ting', 'Initials': 'WT', 'LastName': 'Xia', 'Affiliation': 'Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Zhejiang Wenzhou 325000, PR China. Electronic address: 891225063@qq.com.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Lin', 'Affiliation': 'Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Zhejiang Wenzhou 325000, PR China. Electronic address: lin801026@163.com.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.02.013'] 32,32383352,Phase I Single-Blinded Randomized Controlled Trial Comparing Balance and Aerobic Training in Degenerative Cerebellar Disease.,"INTRODUCTION Primary deficits in individuals with cerebellar degeneration include ataxia, unstable gait, and incoordination. Balance training is routinely recommended to improve function whereas little is known regarding aerobic training. OBJECTIVE To determine the feasibility of conducting a randomized trial comparing balance and aerobic training in individuals with cerebellar degeneration. DESIGN Assessor blinded randomized control phase I trial. SETTING Assessments in medical center, home training. PARTICIPANTS Twenty participants with cerebellar degeneration were randomized to home balance or aerobic training. INTERVENTION Aerobic training consisted of 4 weeks of stationary bicycle training, five times per week for 30-minute sessions. Home balance training consisted of performing the same duration of easy, moderate, and/or hard exercises. OUTCOME MEASURES Scale for the Assessment and Rating of Ataxia (SARA), maximal oxygen consumption (VO 2 max), Dynamic Gait Index, Timed Up and Go, gait speed. RESULTS All 20 participants completed assigned training with no major adverse events. Seven of each group attained target training duration, frequency, and intensity. Although both groups had significant improvements in ataxia severity, balance, and gait measures, there were greater improvements in individuals who performed aerobic training in ataxia severity and maximal oxygen consumption when compared to balance training. The effect size for these outcome measures was determined to be large, indicating a phase II trial comparing the benefits of aerobic and balance training was feasible and required 26 participants per group. Improvements in SARA score and VO 2 max remained in the aerobic training group at 3 months posttraining, but these improvements were trending back to baseline. In contrast, all balance group measures for pretraining and 3 months posttraining were statistically similar. CONCLUSIONS A phase II trial comparing balance and aerobic training in individuals with cerebellar degeneration is feasible. Benefits trended back toward baseline after training stopped, although benefits of longer duration exercise programs still need to be determined.",2021,"Improvements in SARA score and VO 2 max remained in the aerobic training group at 3 mo post-training, but these improvements were trending back to baseline.","['Assessments in medical center, home-training', 'individuals with cerebellar degeneration', 'individuals with cerebellar degeneration is feasible', 'individuals with cerebellar degeneration include ataxia, unstable gait, and incoordination', '20 participants with cerebellar degeneration', 'Degenerative Cerebellar Disease']","['Aerobic training consisted of four-weeks of stationary bicycle training', 'aerobic and balance training', 'Balance training', 'aerobic training', 'home balance or aerobic training', 'Balance and Aerobic Training', 'balance and aerobic training']","['SARA score and VO 2 max', 'Scale for the Assessment and Rating of Ataxia (SARA), maximal oxygen consumption (VO2max), Dynamic Gait Index (DGI), Timed up and Go (TUG), gait speed', 'ataxia severity and maximal oxygen consumption', 'ataxia severity, balance, and gait measures']","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0262404', 'cui_str': 'Cerebellar degeneration'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004134', 'cui_str': 'Ataxia'}, {'cui': 'C0231686', 'cui_str': 'Unsteady gait'}, {'cui': 'C0520966', 'cui_str': 'Incoordination'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0007760', 'cui_str': 'Cerebellar disorder'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0392218', 'cui_str': 'Bicycle exerciser'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C4760258', 'cui_str': 'Ataxia assessment scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C2919794', 'cui_str': 'Dynamic gait index'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0004134', 'cui_str': 'Ataxia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",20.0,0.0295574,"Improvements in SARA score and VO 2 max remained in the aerobic training group at 3 mo post-training, but these improvements were trending back to baseline.","[{'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Barbuto', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Physicians and Surgeons, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Martelli', 'Affiliation': 'Department of Engineering, Columbia University, New York, NY, USA.'}, {'ForeName': 'Omofuma', 'Initials': 'O', 'LastName': 'Isirame', 'Affiliation': 'Department of Engineering, Columbia University, New York, NY, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Physicians and Surgeons, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Bishop', 'Affiliation': 'Division of Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Sheng-Han', 'Initials': 'SH', 'LastName': 'Kuo', 'Affiliation': 'Department of Neurology, College of Physicians and Surgeons, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': 'Department of Engineering, Columbia University, New York, NY, USA.'}, {'ForeName': 'Seonjoo', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Biostatistics, College of Physicians and Surgeons, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': ""O'Dell"", 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Stein', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Physicians and Surgeons, Columbia University Medical Center, New York, NY, USA.'}]","PM & R : the journal of injury, function, and rehabilitation",['10.1002/pmrj.12401'] 33,32380509,Role of feeding strategy bundle with acid-suppressive therapy in infants with esophageal acid reflux exposure: a randomized controlled trial.,"OBJECTIVE To test the hypothesis that a feeding bundle concurrent with acid suppression is superior to acid suppression alone in improving gastroesophageal reflux disease (GERD) attributed-symptom scores and feeding outcomes in neonatal ICU infants. METHODS Infants (N = 76) between 34 and 60 weeks' postmenstrual age with acid reflux index > 3% were randomly allocated to study (acid-suppressive therapy + feeding bundle) or conventional (acid-suppressive therapy only) arms for 4 weeks. Feeding bundle included: total fluid volume < 140 mL/kg/day, fed over 30 min in right lateral position, and supine postprandial position. Primary outcome was independent oral feeding and/or ≥6-point decrease in symptom score (I-GERQ-R). Secondary outcomes included growth (weight, length, head circumference), length of hospital stay (LOHS, days), airway (oxygen at discharge), and developmental (Bayley scores) milestones. RESULTS Of 688 screened: 76 infants were randomized and used for the primary outcome as intent-to-treat, and secondary outcomes analyzed for 72 infants (N = 35 conventional, N = 37 study). For study vs. conventional groups, respectively: (a) 33% (95% CI, 19-49%) vs. 44% (95% CI, 28-62%), P = 0.28 achieved primary outcome success, and (b) secondary outcomes did not significantly differ (P > 0.05). CONCLUSIONS Feeding strategy modifications concurrent with acid suppression are not superior to PPI alone in improving GERD symptoms or discharge feeding, short-term and long-term outcomes. IMPACT Conservative feeding therapies are thought to modify GERD symptoms and its consequences. However, in this randomized controlled trial in convalescing neonatal ICU infants with GERD symptoms, when controlling for preterm or full-term birth and severity of esophageal acid reflux index, the effectiveness of acid suppression plus a feeding modification bundle (volume restriction, intra- and postprandial body positions, and prolonged feeding periods) vs. acid suppression alone, administered over a 4-week period was not superior in improving symptom scores or feeding outcomes. Restrictive feeding strategies are of no impact in modifying GERD symptoms or clinically meaningful outcomes. Further studies are needed to define true GERD and to identify effective therapies in modifying pathophysiology and outcomes. The improvement in symptoms and feeding outcomes over time irrespective of feeding modifications may suggest a maturational effect. This study justifies the use of placebo-controlled randomized clinical trial among NICU infants with objectively defined GERD.",2021,"CONCLUSIONS Feeding strategy modifications concurrent with acid suppression are not superior to PPI alone in improving GERD symptoms or discharge feeding, short-term and long-term outcomes. ","['neonatal ICU infants', '72 infants (N\u2009=\u200935 conventional, N\u2009=\u200937 study', 'infants with esophageal acid reflux exposure', 'Of 688 screened: 76 infants', 'NICU infants with objectively defined GERD', ""Infants (N\u2009=\u200976) between 34 and 60 weeks' postmenstrual age with acid reflux index\u2009>\u20093"", 'convalescing neonatal ICU infants with GERD symptoms']","['study (acid-suppressive therapy\u2009+\u2009feeding bundle) or conventional (acid-suppressive therapy', 'Feeding bundle included: total fluid volume\u2009<\u2009140\u2009mL/kg/day, fed over 30\u2009min in right lateral position, and supine postprandial position', 'acid-suppressive therapy', 'placebo']","['oral feeding and/or ≥6-point decrease in symptom score (I-GERQ-R', 'growth (weight, length, head circumference), length of hospital stay (LOHS, days), airway (oxygen at discharge), and developmental (Bayley scores) milestones']","[{'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0856449', 'cui_str': 'Acid reflux (oesophageal)'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0205367', 'cui_str': 'Suppressive'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449971', 'cui_str': 'Volume of fluid used'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C1532579', 'cui_str': 'mL/kg/day'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0559228', 'cui_str': 'Right lateral decubitus position'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}]",76.0,0.114882,"CONCLUSIONS Feeding strategy modifications concurrent with acid suppression are not superior to PPI alone in improving GERD symptoms or discharge feeding, short-term and long-term outcomes. ","[{'ForeName': 'Sudarshan R', 'Initials': 'SR', 'LastName': 'Jadcherla', 'Affiliation': ""Innovative Infant Feeding Disorders Research Program, Nationwide Children's Hospital, Columbus, OH, USA. Sudarshan.Jadcherla@nationwidechildrens.org.""}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Hasenstab', 'Affiliation': ""Innovative Infant Feeding Disorders Research Program, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Lai', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': 'Center for Biostatistics, Department of Biomedical Informatics, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Erika K', 'Initials': 'EK', 'LastName': 'Osborn', 'Affiliation': ""Innovative Infant Feeding Disorders Research Program, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Sreekanth', 'Initials': 'S', 'LastName': 'Viswanathan', 'Affiliation': ""Innovative Infant Feeding Disorders Research Program, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Ish K', 'Initials': 'IK', 'LastName': 'Gulati', 'Affiliation': ""Innovative Infant Feeding Disorders Research Program, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Slaughter', 'Affiliation': ""Center for Perinatal Research, Abigail Wexner Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Di Lorenzo', 'Affiliation': 'Department of Pediatrics, College of Medicine, The Ohio State University College of Medicine, Columbus, OH, USA.'}]",Pediatric research,['10.1038/s41390-020-0932-4'] 34,32338720,Cycled Phototherapy Dose-Finding Study for Extremely Low-Birth-Weight Infants: A Randomized Clinical Trial.,"Importance Cycled (intermittent) phototherapy (PT) might adequately control peak total serum bilirubin (TSB) level and avoid mortality associated with usual care (continuous PT) among extremely low-birth-weight (ELBW) infants (401-1000 g). Objective To identify a cycled PT regimen that substantially reduces PT exposure, with an increase in mean peak TSB level lower than 1.5 mg/dL in ELBW infants. Design, Setting, and Participants This dose-finding randomized clinical trial of cycled PT vs continuous PT among 305 ELBW infants in 6 US newborn intensive care units was conducted from March 12, 2014, to November 14, 2018. Interventions Two cycled PT regimens (≥15 min/h and ≥30 min/h) were provided using a simple, commercially available timer to titrate PT minutes per hour against TSB level. The comparator arm was usual care (continuous PT). Main Outcomes and Measures Mean peak TSB level and total PT hours through day 14 in all 6 centers and predischarge brainstem auditory-evoked response wave V latency in 1 center. Mortality and major morbidities were secondary outcomes despite limited power. Results Consent was requested for 452 eligible infants and obtained for 305 (all enrolled) (mean [SD] birth weight, 749 [152] g; gestational age, 25.7 [1.9] weeks; 81 infants [27%] were multiple births; 137 infants [45%] were male; 112 [37%] were black infants; and 107 [35%] were Hispanic infants). Clinical and demographic characteristics of the groups were similar at baseline. After a preplanned interim analysis of 100 infants, the regimen of 30 min/h or more was discontinued, and the study proceeded with 2 arms. Comparing 128 infants receiving PT of 15 min/h or more with 128 infants receiving continuous PT among those surviving to 14 days, mean peak TSB levels were 7.1 vs 6.4 mg/dL (adjusted difference, 0.7; 95% CI, 0.4-1.1 mg/dL) and mean total PT hours were 34 vs 72 (adjusted difference, -39; 95% CI, -45 to -32). Wave V latency adjusted for postmenstrual age was similar in 37 infants receiving 15 min/h or more of PT and 33 infants receiving continuous PT: 7.42 vs 7.32 milliseconds (difference, 0.10; 95% CI, -0.11 to 0.30 millisecond). The relative risk for death was 0.79 (95% CI, 0.40-1.54), with a risk difference of -4.5% (95% CI, -10.9 to 2.0). Morbidities did not differ between groups. Conclusions and Relevance Cycled PT can substantially reduce total PT with little increase in peak TSB level. A large, randomized trial is needed to assess whether cycled PT would increase survival and survival without impairment in small, preterm infants. Trial Registration ClinicalTrials.gov Identifier: NCT01944696.",2020,"The relative risk for death was 0.79 (95% CI, 0.40-1.54), with a risk difference of -4.5% (95% CI, -10.9 to 2.0).","['152', 'small, preterm infants', 'Extremely Low-Birth-Weight Infants', '305 ELBW infants in 6 US newborn intensive care units was conducted from March 12, 2014, to November 14, 2018', '128 infants receiving PT of 15 min/h or more with 128 infants receiving', '452 eligible infants and obtained for 305 (all enrolled) (mean [SD] birth weight, 749', 'g; gestational age, 25.7 [1.9] weeks; 81 infants [27%] were multiple births; 137 infants [45%] were male; 112 [37%] were black infants; and 107 [35%] were Hispanic infants']","['continuous PT', 'cycled PT vs continuous PT', 'Importance\n\n\nCycled (intermittent) phototherapy (PT']","['TSB) level and avoid mortality associated with usual care (continuous PT', 'peak TSB level', 'survival and survival', 'mean peak TSB levels', 'Measures\n\n\nMean peak TSB level and total PT hours through day 14 in all 6 centers and predischarge brainstem auditory-evoked response wave V latency', 'peak total serum bilirubin', 'relative risk for death', 'mean total PT hours', 'Mortality and major morbidities', 'mean peak TSB level', 'Morbidities']","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0456065', 'cui_str': 'Extremely low birth weight infant'}, {'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C4517517', 'cui_str': '1.9'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0026753', 'cui_str': 'Multiple Births'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}]","[{'cui': 'C1278039', 'cui_str': 'Serum total bilirubin measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0079319', 'cui_str': 'Brain stem auditory evoked potential'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",452.0,0.186731,"The relative risk for death was 0.79 (95% CI, 0.40-1.54), with a risk difference of -4.5% (95% CI, -10.9 to 2.0).","[{'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Arnold', 'Affiliation': 'McGovern Medical School, University of Texas, Houston.'}, {'ForeName': 'Jon E', 'Initials': 'JE', 'LastName': 'Tyson', 'Affiliation': 'McGovern Medical School, University of Texas, Houston.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pedroza', 'Affiliation': 'McGovern Medical School, University of Texas, Houston.'}, {'ForeName': 'Wally A', 'Initials': 'WA', 'LastName': 'Carlo', 'Affiliation': 'Birmingham School of Medicine, University of Alabama, Birmingham.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Stevenson', 'Affiliation': 'Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Wong', 'Affiliation': 'Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Dempsey', 'Affiliation': 'McGovern Medical School, University of Texas, Houston.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'McGovern Medical School, University of Texas, Houston.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Fonseca', 'Affiliation': 'University of Texas Medical Branch at Galveston.'}, {'ForeName': 'Myra', 'Initials': 'M', 'LastName': 'Wyckoff', 'Affiliation': 'University of Texas Southwestern Medical School, Dallas.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Moreira', 'Affiliation': 'University of Texas Health Science Center at San Antonio.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lasky', 'Affiliation': 'McGovern Medical School, University of Texas, Houston.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2020.0559'] 35,32385848,"Health Literacy and Parental Oral Health Knowledge, Beliefs, Behavior, and Status Among Parents of American Indian Newborns.","OBJECTIVE To examine the relationship between health literacy (HL) and parental oral health knowledge, beliefs, behavior, and self-reported oral health status (OHS) among parents of American Indian (AI) children. METHODS This analysis used baseline data from a randomized controlled trial that tested an oral health intervention with parents of AI newborns. Participants were recruited in parent-child dyads (N = 579). Parents completed items assessing sociodemographic characteristics, HL, and parental oral health knowledge, beliefs, behavior, and self-reported OHS. We examined the correlation of HL with each oral health construct, controlling for parent age and income. RESULTS On average, parents felt quite confident in their HL skills, performed well on questions assessing parental oral health knowledge, and endorsed beliefs likely to encourage positive parental oral health behaviors (e.g., confidence that one can successfully engage in such behaviors). Parents with more limited HL had significantly less knowledge, perceived cavities to be less severe, perceived more barriers and fewer benefits to recommended oral health behaviors, were less confident they could engage in these behaviors, and were more likely to believe their children's oral health was under the control of the dentist or a matter of chance (P values < 0.001). Limited HL was not associated with behavior (P > 0.05) but was linked to worse self-reported OHS (P = 0.040). CONCLUSIONS HL was associated with parental oral health knowledge, beliefs, and self-reported OHS. Oral health education interventions targeting AI families should facilitate development of knowledge and positive oral health beliefs among parents with more limited HL skills.",2020,Oral health education interventions targeting AI families should facilitate development of knowledge and positive oral health beliefs among parents with more limited HL skills.,"['Participants were recruited in parent-child dyads (N\u2009=\u2009579', 'parents with more limited HL skills', 'with parents of AI newborns', 'Parents of American Indian Newborns', 'parents of American Indian (AI) children']",['oral health intervention'],"['sociodemographic characteristics, HL, and parental oral health knowledge, beliefs, behavior, and self-reported OHS', 'health literacy (HL) and parental oral health knowledge, beliefs, behavior, and self-reported oral health status (OHS', 'Health Literacy and Parental Oral Health Knowledge, Beliefs, Behavior, and Status']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.0459279,Oral health education interventions targeting AI families should facilitate development of knowledge and positive oral health beliefs among parents with more limited HL skills.,"[{'ForeName': 'Angela G', 'Initials': 'AG', 'LastName': 'Brega', 'Affiliation': 'Centers for American Indian and Alaska Native Health, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, 13055 East 17th Avenue, Aurora, CO, 80045, USA. angela.brega@cuanschutz.edu.'}, {'ForeName': 'Luohua', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Epidemiology, School of Medicine, University of California Irvine, 205B Irvine Hall, Irvine, CA, 92697, USA.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Johnson', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, 13001 East 17th Place, Aurora, CO, 80045, USA.'}, {'ForeName': 'Anne R', 'Initials': 'AR', 'LastName': 'Wilson', 'Affiliation': 'Department of Pediatric Dentistry, School of Dental Medicine, University of Colorado Anschutz Medical Campus, 13123 East 16th Avenue, Aurora, CO, 80045, USA.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Schmiege', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, 13001 East 17th Place, Aurora, CO, 80045, USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Albino', 'Affiliation': 'Centers for American Indian and Alaska Native Health, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, 13055 East 17th Avenue, Aurora, CO, 80045, USA.'}]",Journal of racial and ethnic health disparities,['10.1007/s40615-019-00688-4'] 36,32390248,An assessment of the centrally acting muscle relaxant tolperisone on driving ability and cognitive effects compared to placebo and cyclobenzaprine.,"WHAT IS KNOWN AND OBJECTIVE Tolperisone is a centrally acting muscle relaxant under development in the United States as a treatment for acute and painful symptoms of muscle spasms. The objective of this three-way, randomized, blinded, three-period crossover study was to assess the safety and cognitive effects of tolperisone compared to placebo and the widely used muscle relaxant cyclobenzaprine in healthy volunteers. METHODS Subjects were randomized to 1 of 3 treatment arms to receive tolperisone (150 mg), cyclobenzaprine (10 mg) or placebo 3 times per day (TID) in 3 separate study periods. Subjects completed a driving test on the Cognitive Research Corporation's Driving Simulator (CRCDS Mini-Sim), a validated driving simulator, on day 1 at time to maximum plasma concentration, on day 2 before the morning dose of study drug and on day 3 at steady state following the morning dose. Subjects were assessed on various driving parameters and on a computer-administered digit-symbol substitution test (CogScreen symbol digit coding test). The driving scenario is a monotonous 100 km highway route on which subjects are instructed to maintain speed and lane position. RESULTS AND DISCUSSION The performance of subjects who had received tolperisone was not significantly different from those who had received placebo in terms of the primary end point: standard deviation of lateral position, a measure of weaving. Subjects who had received tolperisone also performed comparably to those who had received placebo on a range of secondary measures assessing driving ability, cognition and psychomotor performance. In contrast, subjects who had received cyclobenzaprine showed significant impairment compared to placebo (P < .01) on the primary end point of standard deviation of lateral position and on the majority of the secondary end points of driving ability. Despite their markedly poorer driving performance after receiving cyclobenzaprine, few subjects reported feeling unsafe to drive on day 1 (10.3%) and day 2 (3.4%). The incidence of adverse events was similar for tolperisone (36.4%) and placebo (29.0%) and was greater for cyclobenzaprine (45.4%). WHAT IS NEW AND CONCLUSION Subjects who received tolperisone (150 mg TID) experienced no impact on various measures of driving, self-reported sleepiness and cognition measures compared to placebo, in contrast to those who received the widely used muscle relaxant cyclobenzaprine (10 mg TID).",2020,"In contrast, subjects who had received cyclobenzaprine showed significant impairment compared to placebo (P < .01) on the primary end point of standard deviation of lateral position and on the majority of the secondary end points of driving ability.","['Subjects who had received tolperisone also performed comparably to those who had received', 'healthy volunteers', 'Subjects']","['cyclobenzaprine', 'muscle relaxant cyclobenzaprine', 'relaxant cyclobenzaprine', 'tolperisone', 'placebo and cyclobenzaprine', 'placebo']","['safety and cognitive effects', 'driving ability and cognitive effects', 'driving ability, cognition and psychomotor performance', 'incidence of adverse events', 'standard deviation of lateral position, a measure of weaving']","[{'cui': 'C0040382', 'cui_str': 'Tolperisone'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0056732', 'cui_str': 'cyclobenzaprine'}, {'cui': 'C0026827', 'cui_str': 'Decreased muscle tone'}, {'cui': 'C0040382', 'cui_str': 'Tolperisone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0033923', 'cui_str': 'Psychomotor Performance'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0444379', 'cui_str': 'Lateral decubitus position'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0895344,"In contrast, subjects who had received cyclobenzaprine showed significant impairment compared to placebo (P < .01) on the primary end point of standard deviation of lateral position and on the majority of the secondary end points of driving ability.","[{'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Caron', 'Affiliation': 'Neurana Pharmaceuticals, Inc., San Diego, CA, USA.'}, {'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Kaye', 'Affiliation': 'Neurana Pharmaceuticals, Inc., San Diego, CA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wessel', 'Affiliation': 'Neurana Pharmaceuticals, Inc., San Diego, CA, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Halseth', 'Affiliation': 'Neurana Pharmaceuticals, Inc., San Diego, CA, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Kay', 'Affiliation': 'Drug Development, Cognitive Research Corporation, St. Petersburg, FL, USA.'}]",Journal of clinical pharmacy and therapeutics,['10.1111/jcpt.13165'] 37,32330272,The effect of zolpidem on memory consolidation over a night of sleep.,"STUDY OBJECTIVES Nonrapid eye movement sleep boosts hippocampus-dependent, long-term memory formation more so than wake. Studies have pointed to several electrophysiological events that likely play a role in this process, including thalamocortical sleep spindles (12-15 Hz). However, interventional studies that directly probe the causal role of spindles in consolidation are scarce. Previous studies have used zolpidem, a GABA-A agonist, to increase sleep spindles during a daytime nap and promote hippocampal-dependent episodic memory. The current study investigated the effect of zolpidem on nighttime sleep and overnight improvement of episodic memories. METHODS We used a double-blind, placebo-controlled within-subject design to test the a priori hypothesis that zolpidem would lead to increased memory performance on a word-paired associates task by boosting spindle activity. We also explored the impact of zolpidem across a range of other spectral sleep features, including slow oscillations (0-1 Hz), delta (1-4 Hz), theta (4-8 Hz), sigma (12-15 Hz), as well as spindle-SO coupling. RESULTS We showed greater memory improvement after a night of sleep with zolpidem, compared to placebo, replicating a prior nap study. Additionally, zolpidem increased sigma power, decreased theta and delta power, and altered the phase angle of spindle-SO coupling, compared to placebo. Spindle density, theta power, and spindle-SO coupling were associated with next-day memory performance. CONCLUSIONS These results are consistent with the hypothesis that sleep, specifically the timing and amount of sleep spindles, plays a causal role in the long-term formation of episodic memories. Furthermore, our results emphasize the role of nonrapid eye movement theta activity in human memory consolidation.",2020,"Additionally, zolpidem increased sigma power, decreased theta and delta power, and altered the phase angle of spindle-SO coupling, compared to placebo.",[],"['zolpidem', 'Zolpidem', 'placebo']","['Memory Consolidation', 'nighttime sleep and overnight improvement of episodic memories', 'Spindle density, theta power, and spindle-SO coupling', 'memory performance', 'sigma power, decreased theta and delta power']",[],"[{'cui': 'C0078839', 'cui_str': 'zolpidem'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0679057', 'cui_str': 'Memory Consolidation'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C1285654', 'cui_str': 'Memory performance'}, {'cui': 'C1719918', 'cui_str': 'Sigma'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0439097', 'cui_str': 'Delta'}]",,0.04903,"Additionally, zolpidem increased sigma power, decreased theta and delta power, and altered the phase angle of spindle-SO coupling, compared to placebo.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Cognitive Sciences, University of California, Irvine.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Yetton', 'Affiliation': 'Department of Cognitive Sciences, University of California, Irvine.'}, {'ForeName': 'Lauren N', 'Initials': 'LN', 'LastName': 'Whitehurst', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Naji', 'Affiliation': 'Department of Medicine, University of California, San Diego.'}, {'ForeName': 'Sara C', 'Initials': 'SC', 'LastName': 'Mednick', 'Affiliation': 'Department of Cognitive Sciences, University of California, Irvine.'}]",Sleep,['10.1093/sleep/zsaa084'] 38,32392574,Autosomal-dominant polycystic kidney disease: tolvaptan use in adolescents and young adults with rapid progression.,"BACKGROUND The phase 3 Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and Its Outcomes (TEMPO 3:4) clinical trial demonstrated the beneficial effect of tolvaptan on kidney growth and function in subjects aged 18-50 years over a 3-year period. However, it did not specifically assess the use of tolvaptan in adolescents and young adults (AYAs) with ADPKD. METHODS A post hoc analysis of the TEMPO 3:4 trials was performed for patients aged 18-24 years. The primary outcome was the annual rate of change in total kidney volume (TKV). The secondary outcome was to evaluate long-term safety of tolvaptan using Hy's law of hepatotoxicity. RESULTS A total of 51 patients in the 18-24 age group were analyzed (tolvaptan: 29, placebo: 22). The tolvaptan group had a lower mean percentage of TKV growth per year compared to the placebo group (3.9% vs. 6.5%, P = 0.0491). For secondary outcomes, 63 patients in the AYA subgroup were evaluated. In both the AYA and adult groups, none of the patients met the criteria for Hy's law of hepatotoxicity. CONCLUSIONS This post hoc analysis suggests that tolvaptan, with appropriate patient selection and management, can provide effective and acceptably safe treatment in AYAs with ADPKD. IMPACT Tolvaptan slows the increase in total kidney volume in patients aged 18-24 years with ADPKD. Tolvaptan posed no risk of potential liver injury measured via Hy's law of hepatotoxicity in the AYA stratum. This study suggests that tolvaptan has beneficial outcomes in AYAs. This post hoc analysis suggests the need for additional studies with a larger pediatric patient population. The impact is significant as tolvaptan had not been specifically examined in the AYA patient population previously.",2021,"In both the AYA and adult groups, none of the patients met the criteria for Hy's law of hepatotoxicity. ","['A total of 51 patients in the 18-24 age group were analyzed (tolvaptan: 29', 'patients aged 18-24 years', 'patients aged 18-24 years with', 'adolescents and young adults (AYAs) with ADPKD', '63 patients in the AYA subgroup were evaluated', 'adolescents and young adults with rapid progression', 'subjects aged 18-50 years over a 3-year period']","['tolvaptan', 'ADPKD.Tolvaptan', 'placebo']","['total kidney volume', 'kidney growth and function', 'annual rate of change in total kidney volume (TKV', ""evaluate long-term safety of tolvaptan using Hy's law of hepatotoxicity"", 'TKV growth per year']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0085413', 'cui_str': 'Autosomal dominant polycystic kidney disease'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]","[{'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C0023150', 'cui_str': 'Law'}, {'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}, {'cui': 'C0439508', 'cui_str': '/year'}]",,0.140569,"In both the AYA and adult groups, none of the patients met the criteria for Hy's law of hepatotoxicity. ","[{'ForeName': 'Rupesh', 'Initials': 'R', 'LastName': 'Raina', 'Affiliation': 'Department of Nephrology, Akron Nephrology Associates/Cleveland Clinic Akron General Medical Center, Akron, OH, USA. rraina@akronchildrens.org.'}, {'ForeName': 'Ronith', 'Initials': 'R', 'LastName': 'Chakraborty', 'Affiliation': ""Department of Nephrology, Akron Children's Hospital, Akron, OH, USA.""}, {'ForeName': 'Meredith E', 'Initials': 'ME', 'LastName': 'DeCoy', 'Affiliation': 'Ohio University Heritage College of Osteopathic Medicine, Athens, OH, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Kline', 'Affiliation': 'Mayo Clinic College of Medicine, Rochester, MN, USA.'}]",Pediatric research,['10.1038/s41390-020-0942-2'] 39,32334632,"The Balanced Opioid Initiative: protocol for a clustered, sequential, multiple-assignment randomized trial to construct an adaptive implementation strategy to improve guideline-concordant opioid prescribing in primary care.","BACKGROUND Rates of opioid prescribing tripled in the USA between 1999 and 2015 and were associated with significant increases in opioid misuse and overdose death. Roughly half of all opioids are prescribed in primary care. Although clinical guidelines describe recommended opioid prescribing practices, implementing these guidelines in a way that balances safety and effectiveness vs. risk remains a challenge. The literature offers little help about which implementation strategies work best in different clinical settings or how strategies could be tailored to optimize their effectiveness in different contexts. Systems consultation consists of (1) educational/engagement meetings with audit and feedback reports, (2) practice facilitation, and (3) prescriber peer consulting. The study is designed to discover the most cost-effective sequence and combination of strategies for improving opioid prescribing practices in diverse primary care clinics. METHODS/DESIGN The study is a hybrid type 3 clustered, sequential, multiple-assignment randomized trial (SMART) that randomizes clinics from two health systems at two points, months 3 and 9, of a 21-month intervention. Clinics are provided one of four sequences of implementation strategies: a condition consisting of educational/engagement meetings and audit and feedback alone (EM/AF), EM/AF plus practice facilitation (PF), EM/AF + prescriber peer consulting (PPC), and EM/AF + PF + PPC. The study's primary outcome is morphine-milligram equivalent (MME) dose by prescribing clinicians within clinics. The study's primary aim is the comparison of EM/AF + PF + PPC versus EM/AF alone on change in MME from month 3 to month 21. The secondary aim is to derive cost estimates for each of the four sequences and compare them. The exploratory aim is to examine four tailoring variables that can be used to construct an adaptive implementation strategy to meet the needs of different primary care clinics. DISCUSSION Systems consultation is a practical blend of implementation strategies used in this case to improve opioid prescribing practices in primary care. The blend offers a range of strategies in sequences from minimally to substantially intensive. The results of this study promise to help us understand how to cost effectively improve the implementation of evidence-based practices. TRIAL REGISTRATION NCT04044521 (ClinicalTrials.gov). Registered 05 August 2019.",2020,"BACKGROUND Rates of opioid prescribing tripled in the USA between 1999 and 2015 and were associated with significant increases in opioid misuse and overdose death.","['primary care', 'diverse primary care clinics']","['EM/AF + PF + PPC versus EM/AF alone', 'educational/engagement meetings and audit and feedback alone (EM/AF), EM/AF plus practice facilitation (PF), EM/AF + prescriber peer consulting (PPC), and EM/AF + PF + PPC']","['opioid misuse and overdose death', 'morphine-milligram equivalent (MME) dose by prescribing clinicians within clinics']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}]","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]",,0.0591709,"BACKGROUND Rates of opioid prescribing tripled in the USA between 1999 and 2015 and were associated with significant increases in opioid misuse and overdose death.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Quanbeck', 'Affiliation': 'Department of Family Medicine and Community Health, University of Wisconsin-Madison, 800 University Bay Drive, Suite 210, Madison, WI, 53705-2278, USA. arquanbe@wisc.edu.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Almirall', 'Affiliation': 'Department of Statistics and Institute for Social Research, University of Michigan, 2448 Institute for Social Research, 426 Thompson St., Ann Arbor, MI, 48104-2321, USA.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Jacobson', 'Affiliation': 'Institute for Clinical and Translational Research and School of Nursing, University of Wisconsin, Madison, 5130 Signe Skott Cooper Hall, 701 Highland Ave, Madison, WI, 53705-2202, USA.'}, {'ForeName': 'Randall T', 'Initials': 'RT', 'LastName': 'Brown', 'Affiliation': 'Department of Family Medicine and Community Health, University of Wisconsin-Madison, 1100 Delaplaine Ct, Madison, WI, 53705-1840, USA.'}, {'ForeName': 'Jillian K', 'Initials': 'JK', 'LastName': 'Landeck', 'Affiliation': 'Department of Family Medicine and Community Health, University of Wisconsin-Madison, 1100 Delaplaine Ct, Madison, WI, 53705-1840, USA.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Madden', 'Affiliation': 'APT Foundation, 1 Long Wharf Drive, Suite 321, New Haven, CT, 06511-5991, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Cohen', 'Affiliation': 'Bellin Health Systems, Inc., 744 S. Webster Ave, Green Bay, WI, 54305, USA.'}, {'ForeName': 'Brienna M F', 'Initials': 'BMF', 'LastName': 'Deyo', 'Affiliation': 'Department of Family Medicine and Community Health, University of Wisconsin-Madison, 1100 Delaplaine Ct, Madison, WI, 53705-1840, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Robinson', 'Affiliation': 'Forward Data Analytic Services, LLC, 6700 Cross Country Road, Verona, WI, 53593, USA.'}, {'ForeName': 'Roberta A', 'Initials': 'RA', 'LastName': 'Johnson', 'Affiliation': 'Department of Family Medicine and Community Health, University of Wisconsin-Madison, 800 University Bay Drive, Suite 210, Madison, WI, 53705-2278, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Schumacher', 'Affiliation': 'Department of Family Medicine and Community Health, University of Wisconsin-Madison, 800 University Bay Drive, Suite 210, Madison, WI, 53705-2278, USA.'}]",Implementation science : IS,['10.1186/s13012-020-00990-4'] 40,31617830,Fear of cancer recurrence in lymphoma survivors: A descriptive study.,"Objectives: Fear of cancer recurrence (FCR) is a common experience among cancer survivors and often persists after the termination of cancer treatments. The purpose of this paper was to evaluate FCR in survivors of Hodgkin's and diffuse large B-cell lymphomas, given a high rate of survivorship in this patient population. Research Approach: The parent study was a multi-site, cluster-randomized trial to assess a communication skills intervention: survivorship planning consultation (versus a time-attention control - wellness rehabilitation intervention) to promote transition to survivorship. Participants & Methodological Approach: 199 patients enrolled in the study and completed a survivorship (or control) consultation one-month after receiving the news of their survivorship status; 141 of those patients ( n  = 92 experimental arm, n  = 49 control arm) completed an interview at their 6-month follow-up consultation. In the interview, participants described frequency of FCR, causes of FCR, coping mechanisms, and specific things oncologists said to reduce FCR. Both qualitative and quantitative methods were utilized for analyzing participant responses. Findings: The majority (88%) of participants reported experiencing FCR, with a higher number of participants in the experimental arm significantly more likely to endorse FCR compared to the control group participants. The main causes of FCR were having medical appointments and concerns about potential relapse and secondary cancers. Participants endorsed utilizing self-sufficient coping mechanisms. As well, participants reported that oncologists most frequently cited specific cure rates of lymphoma to reduce patients' FCR. Interpretation & Implications for Psychosocial Providers: Communication skills training programs should emphasize FCR in survivorship consultations.",2020,"The majority (88%) of participants reported experiencing FCR, with a higher number of participants in the experimental arm significantly more likely to endorse FCR compared to the control group participants.","['lymphoma survivors', '199 patients enrolled in the study and completed a survivorship (or control) consultation one-month after receiving the news of their survivorship status; 141 of those patients ( n \u2009=\u200992 experimental arm, n \u2009=\u200949 control arm) completed an interview at their 6-month follow-up consultation']",['communication skills intervention: survivorship planning consultation (versus a time-attention control - wellness rehabilitation intervention'],"['Fear of cancer recurrence', 'Fear of cancer recurrence (FCR', 'endorse FCR']","[{'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038955'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C4082115', 'cui_str': 'One month (qualifier value)'}, {'cui': 'C0282425', 'cui_str': 'News'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0422322', 'cui_str': 'Follow-up consultation (procedure)'}]","[{'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0038955'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0233705', 'cui_str': 'Fear of getting cancer (finding)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",199.0,0.0549378,"The majority (88%) of participants reported experiencing FCR, with a higher number of participants in the experimental arm significantly more likely to endorse FCR compared to the control group participants.","[{'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Latella', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Rogers', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Leventhal', 'Affiliation': 'Department of Psychology, Rutgers University, New Brunswick, New Jersey, USA.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Parker', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Horwitz', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Matasar', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Carma L', 'Initials': 'CL', 'LastName': 'Bylund', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Kissane', 'Affiliation': ""Cunningham Centre for Palliative Care Research, University of Notre Dame Australia and St Vincent's Sydney, Sydney, Australia.""}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Franco', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Smita C', 'Initials': 'SC', 'LastName': 'Banerjee', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}]",Journal of psychosocial oncology,['10.1080/07347332.2019.1677840'] 41,31833452,"A multi-center randomized controlled trial to reduce unmet needs, depression, and anxiety among hematological cancer patients and their support persons.","Purpose: Individuals diagnosed with a high-grade hematological malignancy are at high risk for psychosocial distress. This study aimed to examine the effectiveness of a web-based information tool and nurse delivered telephone support in reducing: (i) unmet information needs; (ii) depression; and (iii) anxiety, among hematological cancer patients and their support persons (SPs). Methods: Patients with a new diagnosis of acute myeloid leukemia, acute lymphoblastic leukemia, Burkitt lymphoma, or lymphoblastic lymphoma and their SPs were enrolled in a prospective multi-site randomized trial. Participants received either access to an online information tool and telephone support from a hematology nurse, or usual care. Outcome data were collected 2, 4, 8, and 12 weeks post-recruitment. The primary endpoint was unmet information needs. Results: Data from 60 patients and 15 SPs were included in the analysis. There were no statistically significant differences in unmet information needs, depression or anxiety between intervention and control groups for patients. Patients in both groups demonstrated a decrease in information needs over the intervention period. Post hoc analyses revealed that patients who did not achieve remission with the first cycle of treatment experienced increased anxiety from 4 weeks until the end of the study ( p  = 0.008). Conclusions: A web-based information tool and nurse delivered telephone support did not reduce unmet information needs, depression or anxiety among hematological cancer patients, however this finding is inconclusive given the low power of the study. Implications for Psychosocial Providers or Policy: Patients who do not achieve remission are at high risk of anxiety, and may benefit from targeted psychological intervention.",2020,"A web-based information tool and nurse delivered telephone support did not reduce unmet information needs, depression or anxiety among hematological cancer patients, however this finding is inconclusive given the low power of the study.","['hematological cancer patients', '60 patients and 15 SPs were included in the analysis', 'hematological cancer patients and their support persons', 'Individuals diagnosed with a high-grade hematological malignancy are at high risk for psychosocial distress', 'hematological cancer patients and their support persons (SPs', 'Patients with a new diagnosis of acute myeloid leukemia, acute lymphoblastic leukemia, Burkitt lymphoma, or lymphoblastic lymphoma and their SPs']","['web-based information tool and nurse delivered telephone support', 'access to an online information tool and telephone support from a hematology nurse, or usual care']","['information needs', 'anxiety', 'unmet information needs, depression or anxiety']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0085292', 'cui_str': 'Stiff-man syndrome'}, {'cui': 'C2585997', 'cui_str': 'New diagnosis'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0006413', 'cui_str': 'Burkitt lymphoma'}, {'cui': 'C0079748', 'cui_str': 'Precursor cell lymphoblastic lymphoma'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}]","[{'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",60.0,0.0884696,"A web-based information tool and nurse delivered telephone support did not reduce unmet information needs, depression or anxiety among hematological cancer patients, however this finding is inconclusive given the low power of the study.","[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Stevenson', 'Affiliation': 'Department of Haematology, Royal North Shore Hospital, Kolling Institute of Medical Research, University of Sydney, St Leonards, New South Wales, Australia.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Bryant', 'Affiliation': 'Faculty of Health and Medicine, Health Behaviour Research Collaborative, School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Rochelle', 'Initials': 'R', 'LastName': 'Watson', 'Affiliation': 'Faculty of Health and Medicine, Health Behaviour Research Collaborative, School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Sanson-Fisher', 'Affiliation': 'Faculty of Health and Medicine, Health Behaviour Research Collaborative, School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Oldmeadow', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Henskens', 'Affiliation': 'Faculty of Health and Medicine, Health Behaviour Research Collaborative, School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Brown', 'Affiliation': 'Department of Haematology, Royal Prince Alfred Hospital, University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Sundra', 'Initials': 'S', 'LastName': 'Ramanathan', 'Affiliation': 'Department of Haematology, St George Hospital, Kogarah, New South Wales, Australia.'}, {'ForeName': 'Campbell', 'Initials': 'C', 'LastName': 'Tiley', 'Affiliation': 'Department of Haematology, Gosford Hospital, Gosford, New South Wales, Australia.'}, {'ForeName': 'Anoop', 'Initials': 'A', 'LastName': 'Enjeti', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Guest', 'Affiliation': 'Department of Haematology, Royal North Shore Hospital, St Leonards, New South Wales, Australia.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Tzelepis', 'Affiliation': 'Priority Research Centre for Health Behaviour, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Paul', 'Affiliation': 'School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': ""D'Este"", 'Affiliation': 'National Centre for Epidemiology and Population Health, Research School of Population Health, Australian National University, Canberra, Australian Capital Territory, Australia.'}]",Journal of psychosocial oncology,['10.1080/07347332.2019.1692991'] 42,32391919,Intravenous itraconazole compared with liposomal amphotericin B as empirical antifungal therapy in patients with neutropaenia and persistent fever.,"BACKGROUND Fungal infections are a major complication of neutropaenia following chemotherapy. Their early diagnosis is difficult, and empirical antifungal treatment is widely used, and uses of less toxic drugs that reduce breakthrough infection are required. OBJECTIVE We conducted a multicentre, open-label, randomised, non-inferiority trial to compare the safety and efficacy of intravenous itraconazole (ivITCZ) and liposomal amphotericin B (LAmB) as empirical antifungal therapy in patients with haematological malignancies with neutropaenia and persistent fever. METHODS Patients with haematological malignancies who developed fever refractory to broad-spectrum antibacterial agents under neutropaenia conditions were enrolled. Patients were randomised for treatment with LAmB (3.0 mg/kg/d) or ivITCZ (induction: 400 mg/d, maintenance: 200 mg/d). RESULTS Observed overall favourable response rates of 17/52 (32.7%) and 18/50 (36.0%) in the LAmB and ivITCZ groups, with a model-based estimate of a 4% difference (90% CI, -12% to 20%), did not fulfil the statistical non-inferiority criterion. In the LAmB group, there were two cases of breakthrough infection and five cases of probable invasive fungal disease, whereas in the itraconazole group, neither breakthrough infection nor probable invasive fungal disease occurred. Patients in the ivITCZ group had significantly fewer grade 3-4 hypokalaemia-related events than LAmB group patients (P < .01). The overall incidence of adverse events tended to be lower in the ivITCZ group (P = .07). CONCLUSION ivITCZ showed similar efficacy and safety as LAmB as empirical antifungal therapy in haematological malignancy patients with febrile neutropaenia, although the small sample size and various limitations prevented demonstration of its non-inferiority.",2020,"The overall incidence of adverse events tended to be lower in the ivITCZ group (P = 0.07). ","['patients with neutropaenia and persistent fever', 'haematological malignancy patients with febrile neutropaenia', 'Patients with haematological malignancies who developed fever refractory to broad-spectrum antibacterial agents under neutropaenia conditions were enrolled', 'patients with haematological malignancies with neutropaenia and persistent fever']","['itraconazole', 'itraconazole (ivITCZ) and liposomal amphotericin B (LAmB', 'Intravenous itraconazole', 'ivITCZ', 'LAmB', 'liposomal amphotericin B']","['breakthrough infection nor probable invasive fungal disease', 'overall incidence of adverse events', 'grade 3-4 hypokalaemia-related events', 'efficacy and safety', 'safety and efficacy', 'overall favourable response rates', 'breakthrough infection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0476474', 'cui_str': 'Persistent fever'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0279516', 'cui_str': 'Antibacterial'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1145701', 'cui_str': 'amphotericin B liposomal'}]","[{'cui': 'C3666010', 'cui_str': 'Breakthrough infection'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1262313', 'cui_str': 'Invasive fungal infection'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.107165,"The overall incidence of adverse events tended to be lower in the ivITCZ group (P = 0.07). ","[{'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Yoshida', 'Affiliation': 'Department of Hematologic Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Akiko M', 'Initials': 'AM', 'LastName': 'Saito', 'Affiliation': 'Clinical Research Center, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Department of Clinical Biostatistics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Ilseung', 'Initials': 'I', 'LastName': 'Choi', 'Affiliation': 'Department of Hematology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Hidaka', 'Affiliation': 'Department of Hematology, National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan.'}, {'ForeName': 'Yasuhiko', 'Initials': 'Y', 'LastName': 'Miyata', 'Affiliation': 'Department of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Yoshiko', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'Department of Hematology, National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yamasaki', 'Affiliation': 'Department of Hematology and Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Toshiya', 'Initials': 'T', 'LastName': 'Kagoo', 'Affiliation': 'Department of Hematology and Internal Medicine, National Hospital Organization Tokyo Medical Center, Tokyo, Japan.'}, {'ForeName': 'Hiroatsu', 'Initials': 'H', 'LastName': 'Iida', 'Affiliation': 'Department of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Hiromasa', 'Initials': 'H', 'LastName': 'Niimi', 'Affiliation': 'Department of Internal Medicine, National Hospital Organization Hiroshima-Nishi Medical Center, Otake, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Komeno', 'Affiliation': 'Department of Hematology, National Hospital Organization Mito Medical Center, Higashiibarakigun, Japan.'}, {'ForeName': 'Chikamasa', 'Initials': 'C', 'LastName': 'Yoshida', 'Affiliation': 'Department of Hematology, National Hospital Organization Minami-Okayama Medical Center, Okayama, Japan.'}, {'ForeName': 'Fumihito', 'Initials': 'F', 'LastName': 'Tajima', 'Affiliation': 'Stem Cell Transplantation Center, National Hospital Organization Yonago Medical Center, Yonago, Japan.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Takase', 'Affiliation': 'Department of Hematology and Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Ueno', 'Affiliation': 'Department of Hematology and Internal Medicine, National Hospital Organization Tokyo Medical Center, Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Shimomura', 'Affiliation': 'Department of Internal Medicine, National Hospital Organization Hiroshima-Nishi Medical Center, Otake, Japan.'}, {'ForeName': 'Tatsunori', 'Initials': 'T', 'LastName': 'Sakai', 'Affiliation': 'Department of Hematology, National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Nakashima', 'Affiliation': 'Department of Hematology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Chikashi', 'Initials': 'C', 'LastName': 'Yoshida', 'Affiliation': 'Department of Hematology, National Hospital Organization Mito Medical Center, Higashiibarakigun, Japan.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Kubonishi', 'Affiliation': 'Department of Hematology, National Hospital Organization Okayama Medical Center, Okayama, Japan.'}, {'ForeName': 'Kazutaka', 'Initials': 'K', 'LastName': 'Sunami', 'Affiliation': 'Department of Hematology, National Hospital Organization Okayama Medical Center, Okayama, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Yoshida', 'Affiliation': 'Department of Hematology, National Hospital Organization Nagasaki Medical Center, Omura, Japan.'}, {'ForeName': 'Aki', 'Initials': 'A', 'LastName': 'Sakurai', 'Affiliation': 'Department of Hematologic Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Kaneko', 'Affiliation': 'Department of Bacteriology, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Yoshitsugu', 'Initials': 'Y', 'LastName': 'Miyazaki', 'Affiliation': 'Department of Chemotherapy and Mycoses, National Institute of Infectious Diseases, Tokyo, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Nagai', 'Affiliation': 'Department of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}]",Mycoses,['10.1111/myc.13100'] 43,32406265,Peer Relations and Delinquency Among Girls in Foster Care Following a Skill-Building Preventive Intervention.,"There is evidence that risk for delinquency is elevated among girls with foster care histories, and one correlate of delinquency is affiliating with peers who engage in delinquent behavior. Although intervention studies have shown positive effects of interventions that target delinquent peer affiliation on reductions in delinquency among adolescents with juvenile justice histories, the success of such interventions for younger girls in foster care, without prior involvement with juvenile justice, is unknown. We analyzed data from a randomized clinical trial of the middle school version of the Keep Safe intervention in a sample of girls in foster care ( n = 100). The intervention was delivered to girls and foster parents during the transition to middle school. Path analysis suggested a significant intervention effect on reduction in affiliation with delinquent peers at 12 months ( B = -.21). No significant mediation effects were identified. The middle school Keep Safe intervention shows promise as a preventative intervention for reducing affiliation with delinquent peers, which importantly is associated with adolescent delinquent behavior. Implications for researchers and professionals who tailor and deliver evidence-based programs for girls in foster care are discussed.",2021,"The middle school Keep Safe intervention shows promise as a preventative intervention for reducing affiliation with delinquent peers, which importantly is associated with adolescent delinquent behavior.","['adolescents with juvenile justice histories', 'Girls in Foster Care', 'girls with foster care histories', 'sample of girls in foster care ( n = 100']",['middle school version of the Keep Safe intervention'],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3146221', 'cui_str': 'Juvenile'}, {'cui': 'C0022437', 'cui_str': 'Justice'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0419195', 'cui_str': 'Foster care'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0599066,"The middle school Keep Safe intervention shows promise as a preventative intervention for reducing affiliation with delinquent peers, which importantly is associated with adolescent delinquent behavior.","[{'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Hu', 'Affiliation': '3265University of Oregon, Eugene, OR, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Van Ryzin', 'Affiliation': '3265University of Oregon, Eugene, OR, USA.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Schweer-Collins', 'Affiliation': '3265University of Oregon, Eugene, OR, USA.'}, {'ForeName': 'Leslie D', 'Initials': 'LD', 'LastName': 'Leve', 'Affiliation': '3265University of Oregon, Eugene, OR, USA.'}]",Child maltreatment,['10.1177/1077559520923033'] 44,32335056,Posterior Capsule Opacification With Two Hydrophobic Acrylic Intraocular Lenses: 3-Year Results of a Randomized Trial.,"PURPOSE To compare the incidence and intensity of posterior capsule opacification (PCO) and neodymium-yttrium-aluminum-garnet (Nd:YAG) capsulotomy rates between 2 similar open-loop single-piece hydrophobic acrylic intraocular lenses (IOLs) that differ in the proprietary material characteristics and design features, over a period of 3 years. DESIGN Randomized, prospective, patient- and examiner-masked clinical trial with intraindividual comparison. METHODS Setting: Department of Ophthalmology, Medical University of Vienna, Vienna, Austria. PATIENT POPULATION Eighty patients (160 eyes) had bilateral cataract surgery and received a Vivinex XY1 IOL in 1 eye and an AcrySof SN60WF IOL in the other eye. OBSERVATION PROCEDURES Follow-up examinations were performed 3 years after surgery. Digital retroillumination images were taken of each eye. The amount of PCO (score: 0-10) was assessed subjectively at the slit lamp and objectively using automated image analysis software (AQUA). MAIN OUTCOME MEASURE PCO score (scale, 0-10). RESULTS The mean objective PCO score of the Vivinex XY1 IOLs was 0.9 ± 0.8 compared to the PCO score of 1.4 ± 1.1 for the AcrySof SN60WF IOLs (P < .001). Three years postoperatively, 11.4% of patients had an Nd:YAG capsulotomy in the Vivinex XY1 eye and 18.6% had a capsulotomy in the AcrySof SN60WF eye (P = .23). CONCLUSION The new hydrophobic acrylic Vivinex XY1 IOL showed significantly lower PCO rates and lower YAG rates compared to the AcrySof SN60WF IOL. The interaction of various factors such as hydrophobic material, smooth optic surface, and sharp posterior optic edge plays a key role in PCO development.",2020,The new hydrophobic acrylic Vininex XY1 IOL showed significantly lower PCO rates and lower YAG rates compared to the Acrysof SN60WF IOL.,[' Eighty patients (160 eyes) had bilateral cataract surgery and received a'],"['posterior capsule opacification (PCO) and Nd:YAG capsulotomy rates between two similar open-loop single-piece hydrophobic acrylic intraocular lenses (IOLs', 'Vivinex XY1 IOL in one eye and an Acrysof SN60WF IOL in the other eye', 'hydrophobic acrylic intraocular lenses', 'neodymium:yttrium-aluminium-garnet (Nd:YAG) capsulotomy']","['PCO rates and lower YAG rates', 'mean objective PCO score', 'Posterior capsule opacification score (scale, 0-10']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0521707', 'cui_str': 'Bilateral cataracts'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1444680', 'cui_str': 'Posterior capsule opacification'}, {'cui': 'C0027599', 'cui_str': 'Neodymium'}, {'cui': 'C0043432', 'cui_str': 'Yttrium'}, {'cui': 'C0002367', 'cui_str': 'Aluminum'}, {'cui': 'C0559530', 'cui_str': 'Open loop'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0598629', 'cui_str': 'Hydrophobicity'}, {'cui': 'C0440181', 'cui_str': 'Acrylic dental material'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C1444680', 'cui_str': 'Posterior capsule opacification'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.147149,The new hydrophobic acrylic Vininex XY1 IOL showed significantly lower PCO rates and lower YAG rates compared to the Acrysof SN60WF IOL.,"[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Leydolt', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schartmüller', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Schwarzenbacher', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Röggla', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schriefl', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Menapace', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria. Electronic address: rupert.menapace@meduniwien.ac.at.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.04.011'] 45,32385554,Randomized controlled trial of chlorhexidine wash versus benzoyl peroxide soap for home surgical preparation: neither is effective in removing Cutibacterium from the skin of shoulder arthroplasty patients.,"INTRODUCTION Home chlorhexidine washes prior to shoulder surgery are commonly used in an attempt to reduce the skin bacterial load. However, recent studies have suggested that this agent is relatively ineffective against Cutibacterium acne. Benzoyl peroxide soap is a treatment for acne, but evidence regarding its effectiveness as prophylaxis in shoulder surgery is lacking. Therefore, the objective of this study was to compare the effectiveness of home chlorhexidine washes with benzoyl peroxide soap (BPO) in patients undergoing shoulder arthroplasty surgery in reducing Cutibacterium levels on the skin surface and in the dermis. METHODS Fifty male patients planning to undergo shoulder arthroplasty were consented to be randomized into treatment with 4% chlorhexidine solution (CHG) and 10% benzoyl peroxide soap (BPO) used to wash the operative shoulder the night prior and morning of surgery. Skin swabs prior to incision and dermal wound swabs after incision were obtained, and the bacterial load was reported in a semiquantitative manner as the Specimen Cutibacterium Value (SpCuV). The two groups were compared with regards to the percent positivity of the skin surface and incised dermal edge as well as the bacterial load at each site. RESULTS Skin surface swabs were positive in 100% of patients using CHG and 100% of patients using BPO soap. The Cutibacterium load (SpCuV) on the skin surface was similar between the two groups (CHG 1.6 ± 1.1 vs. BPO 1.5 ± 1.4, p = 0.681). The percentages of dermal cultures that were positive were not significantly different between the two groups (CHG 61% vs BPO 46%, p = 0.369). The Cutibacterium load (SpCuV) on the incised dermal edge was similar between the two groups (CHG 0.8 ± 1.0 vs. BPO 0.8 ± 1.4, p = 0.991). DISCUSSION Neither BPO soap nor chlorhexidine washes prior to shoulder surgery were effective in eliminating Cutibacterium from the skin surface or the incised dermal edge. Further study of means of reducing the Cutibacterium load of the skin at the time of shoulder arthroplasty is warranted.",2020,Neither BPO soap nor chlorhexidine washes prior to shoulder surgery were effective in eliminating Cutibacterium from the skin surface or the incised dermal edge.,"['Fifty male patients planning to undergo shoulder arthroplasty', 'patients undergoing shoulder arthroplasty surgery in reducing Cutibacterium levels on the skin surface and in the dermis', 'shoulder arthroplasty patients']","['benzoyl peroxide soap', 'chlorhexidine washes with benzoyl peroxide soap (BPO', 'chlorhexidine', 'Benzoyl peroxide soap', 'chlorhexidine solution (CHG) and 10% benzoyl peroxide soap (BPO) used to wash the operative shoulder the night prior and morning of surgery']","['Cutibacterium load (SpCuV) on the incised dermal edge', 'Cutibacterium load (SpCuV) on the skin surface', 'percentages of dermal cultures']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0186662', 'cui_str': 'Arthroplasty of shoulder'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C4433919', 'cui_str': 'Cutibacterium'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0011646', 'cui_str': 'Dermis structure'}]","[{'cui': 'C0005088', 'cui_str': 'Benzoyl Peroxide'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C1547959', 'cui_str': 'Wash'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C4433919', 'cui_str': 'Cutibacterium'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0010453', 'cui_str': 'Culture'}]",50.0,0.0230374,Neither BPO soap nor chlorhexidine washes prior to shoulder surgery were effective in eliminating Cutibacterium from the skin surface or the incised dermal edge.,"[{'ForeName': 'Jason E', 'Initials': 'JE', 'LastName': 'Hsu', 'Affiliation': 'Department of Orthopaedics and Sports Medicine, University of Washington, 1959 NE Pacific St., Box 356500, Seattle, WA, 98195, USA.'}, {'ForeName': 'Anastasia J', 'Initials': 'AJ', 'LastName': 'Whitson', 'Affiliation': 'Department of Orthopaedics and Sports Medicine, University of Washington, 1959 NE Pacific St., Box 356500, Seattle, WA, 98195, USA.'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Woodhead', 'Affiliation': 'Department of Orthopaedics and Sports Medicine, University of Washington, 1959 NE Pacific St., Box 356500, Seattle, WA, 98195, USA.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Napierala', 'Affiliation': 'Department of Orthopaedics and Sports Medicine, University of Washington, 1959 NE Pacific St., Box 356500, Seattle, WA, 98195, USA.'}, {'ForeName': 'Davin', 'Initials': 'D', 'LastName': 'Gong', 'Affiliation': 'University of Washington School of Medicine, 1959 NE Pacific St., Box 356500, Seattle, WA, 98195, USA.'}, {'ForeName': 'Frederick A', 'Initials': 'FA', 'LastName': 'Matsen', 'Affiliation': 'Department of Orthopaedics and Sports Medicine, University of Washington, 1959 NE Pacific St., Box 356500, Seattle, WA, 98195, USA. matsen@uw.edu.'}]",International orthopaedics,['10.1007/s00264-020-04594-x'] 46,32394757,Economic evaluation of a multimodal intervention in pre-frail and frail older people with diabetes mellitus: the MID-FRAIL project.,"Background : The aim of this study was to estimate the incremental cost-utility ratio (ICUR) of a multi-modal intervention in frail and pre-frail subjects aged ≥70 years with type-2 diabetes versus usual care group focused on quality adjusted life years (QALYs) in different European countries. Methods : The MID-FRAIL study was a cluster randomized multicentre trial conducted in seven European countries. A cost-utility analysis was carried out based on this study, conducted from the perspective of the health care system with a time horizon of one year. Univariate and probabilistic analysis were carried out to test the robustness of the results. Results : The cost estimation showed the offsetting health effect of the intervention program on total health care costs. The mean annual health care costs were 25% higher among patients in usual care. The mean incremental QALY gained per patient by the intervention group were 0.053 QALY compared with usual care practice. Conclusions : The MID-FRAIL intervention program showed to be the dominant option in comparison with usual care practice. It saved costs to the health care system and achieved worthwhile health gains. This finding should encourage its implementation, at least, in the trial participant countries.",2021,The mean incremental QALY gained per patient by the intervention group were 0.053 QALY compared with usual care practice.,"['frail and pre-frail subjects aged ≥70 years with type-2 diabetes versus usual care group focused on quality-adjusted life years (QALYs) in different European countries', 'pre-frail and frail older people with diabetes mellitus', 'seven European countries']","['multi-modal intervention', 'multimodal intervention']","['incremental cost-utility ratio (ICUR', 'total health care costs', 'mean annual health care costs']","[{'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205453', 'cui_str': '7'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332181', 'cui_str': 'Annual'}]",25.0,0.0428674,The mean incremental QALY gained per patient by the intervention group were 0.053 QALY compared with usual care practice.,"[{'ForeName': 'Luz María', 'Initials': 'LM', 'LastName': 'Peña-Longobardo', 'Affiliation': 'Department of Economic Analysis and Finance, University of Castilla-La Mancha , Toledo, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Oliva-Moreno', 'Affiliation': 'Department of Economic Analysis and Finance, University of Castilla-La Mancha , Toledo, Spain.'}, {'ForeName': 'Neboa', 'Initials': 'N', 'LastName': 'Zozaya', 'Affiliation': 'Department of Health Economics, Weber, Madrid Spain, University of Las Palmas de Gran Canaria , Las Palmas De Gran Canaria, Spain.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Aranda-Reneo', 'Affiliation': 'Department of Economic Analysis and Finance, University of Castilla-La Mancha , Toledo, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Trapero-Bertran', 'Affiliation': 'Research Institute for Evaluation and Public Policies (IRAPP), Universitat Internacional de Catalunya (UIC) , Barcelona, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Laosa', 'Affiliation': 'Servicio de Geriatría, Hospital Universitario de Getafe , Madrid, Spain.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Sinclair', 'Affiliation': 'Foundation for Diabetes Research in Older People, Diabetes Frail Ltd , Luton, UK.'}, {'ForeName': 'Leocadio', 'Initials': 'L', 'LastName': 'Rodríguez-Mañas', 'Affiliation': 'Servicio de Geriatría, Hospital Universitario de Getafe , Madrid, Spain.'}]",Expert review of pharmacoeconomics & outcomes research,['10.1080/14737167.2020.1766970'] 47,32397850,Effect of Berberine Plus Bezafibrate Administration on the Lipid Profile of Patients with Mixed Dyslipidemia: A Pilot Clinical Trial.,"To evaluate the effect of berberine (BBR) plus bezafibrate administration on the lipid profile of patients with mixed dyslipidemia. A double-blind randomized pilot clinical trial with parallel groups was carried out in 36 patients, aged 30-60 years with mixed dyslipidemia [triglycerides (TG) ≥1.7 mM and total cholesterol (TC) ≥5.2 mM]. Patients were assigned to 3 groups of 12 patients each, receiving oral administration during 90 days of BBR 500 mg t.i.d., bezafibrate 400 mg b.i.d., or BBR 500 mg t.i.d. plus bezafibrate 400 mg b.i.d, respectively. Clinical evaluation, lipid profile, glucose, creatinine, and uric acid levels were measured before and after the pharmacological intervention. Kruskal-Wallis, Wilcoxon, Mann-Whitney U, and χ 2 tests were used for statistical analyses; a P  ≤ .05 was considered statistically significant. BBR reduced TC levels. Bezafibrate decreased TG, TC, low-density lipoprotein cholesterol (LDL-C), and very low-density lipoprotein (VLDL) concentrations. BBR plus bezafibrate decreased TG (2.6 ± 0.8 vs. 1.3 ± 0.7 mM, P  = .007), TC (6.3 ± 0.7 vs. 4.6 ± 1.2 mM, P  = .005), LDL-C (3.4 ± 0.6 vs. 2.2 ± 1.3 mM, P  = .037), and VLDL (0.5 ± 0.2 vs. 0.2 ± 0.1 mM, P  = .007) levels. Bezafibrate and BBR plus bezafibrate significantly decreased TG, TC, LDL-C, and VLDL concentrations, and thus, remitting the diagnosis of mixed dyslipidemia in 90% of the patients.",2021,"Bezafibrate decreased TG, TC, low-density lipoprotein cholesterol (LDL-C), and very low-density lipoprotein (VLDL) concentrations.","['patients with mixed dyslipidemia', '36 patients, aged 30-60 years with mixed dyslipidemia [triglycerides (TG) ≥1.7\u2009mM and total cholesterol (TC', 'Patients with Mixed Dyslipidemia']","['berberine (BBR) plus bezafibrate', 'Bezafibrate', 'BBR plus bezafibrate', 'Bezafibrate and BBR plus bezafibrate', 'Berberine Plus Bezafibrate', 'BBR 500\u2009mg t.i.d., bezafibrate 400\u2009mg b.i.d., or BBR 500\u2009mg t.i.d. plus bezafibrate']","['Kruskal-Wallis, Wilcoxon, Mann-Whitney U, and χ', 'TG, TC, LDL-C, and VLDL concentrations, and thus, remitting the diagnosis of mixed dyslipidemia', 'BBR reduced TC levels', 'VLDL', 'Clinical evaluation, lipid profile, glucose, creatinine, and uric acid levels', 'TG, TC, low-density lipoprotein cholesterol (LDL-C), and very low-density lipoprotein (VLDL) concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}]","[{'cui': 'C0005117', 'cui_str': 'Berberine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0005330', 'cui_str': 'Bezafibrate'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C1128912', 'cui_str': 'Bezafibrate 400 MG'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}]",36.0,0.042287,"Bezafibrate decreased TG, TC, low-density lipoprotein cholesterol (LDL-C), and very low-density lipoprotein (VLDL) concentrations.","[{'ForeName': 'Juan M', 'Initials': 'JM', 'LastName': 'León-Martínez', 'Affiliation': 'Health Science University Center, Department of Physiology, Institute of Experimental and Clinical Therapeutics, University of Guadalajara, Guadalajara, Mexico.'}, {'ForeName': 'Esperanza', 'Initials': 'E', 'LastName': 'Martínez-Abundis', 'Affiliation': 'Health Science University Center, Department of Physiology, Institute of Experimental and Clinical Therapeutics, University of Guadalajara, Guadalajara, Mexico.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'González-Ortiz', 'Affiliation': 'Health Science University Center, Department of Physiology, Institute of Experimental and Clinical Therapeutics, University of Guadalajara, Guadalajara, Mexico.'}, {'ForeName': 'Karina G', 'Initials': 'KG', 'LastName': 'Pérez-Rubio', 'Affiliation': 'Health Science University Center, Department of Physiology, Institute of Experimental and Clinical Therapeutics, University of Guadalajara, Guadalajara, Mexico.'}]",Journal of medicinal food,['10.1089/jmf.2020.0029'] 48,32336236,Blood Pressure-Lowering Profiles and Clinical Effects of Angiotensin Receptor Blockers Versus Calcium Channel Blockers.,"Blood pressure-lowering drugs have different blood pressure-lowering profiles. We studied if differences in blood pressure mean and variability can explain the differences in risks of cardiovascular events and death among 15 245 high-risk hypertensive patients randomized to valsartan or amlodipine and followed for 4.2 years in the VALUE trial (Valsartan Antihypertensive Long-Term Use Evaluation). We selected patients with ≥3 visits and performed Cox regression analyses, defining mean blood pressure as a time-dependent covariate and visit-to-visit and within-visit blood pressure variability as the SD. Of 14 996 eligible patients, participants in the valsartan group had higher systolic mean blood pressure by 2.2 mm Hg, higher visit-to-visit systolic variability by 1.4 mm Hg, and higher within-visit systolic variability by 0.2 mm Hg ( P values <0.0001). The higher risks of myocardial infarction and stroke in the valsartan group was attenuated after adjustment for mean and variability of systolic blood pressure, from HR 1.19 (95% CI, 1.02-1.39) to 1.11 (0.96-1.30) and from HR 1.13 (0.96-1.33) to 1.00 (0.85-1.18), respectively. The lower risk of congestive heart failure in the valsartan group was accentuated after adjustment, from HR 0.86 (0.74-1.00) to 0.76 (0.65-0.89). A smaller effect was seen on risk of death, from 1.01 (0.92-1.12) to 0.94 (0.85-1.04). In conclusion, the higher risks of myocardial infarction and stroke in patients randomized to valsartan versus amlodipine were related to the drugs' different blood pressure modulating profiles. The risk of congestive heart failure with valsartan was lower, independent of the less favorable blood pressure modulating profile.",2020,"A smaller effect was seen on risk of death, from 1.01 (0.92-1.12) to 0.94 (0.85-1.04).","['Of 14 996 eligible patients, participants in the', '15 245 high-risk hypertensive patients randomized to']","['Angiotensin Receptor Blockers Versus Calcium Channel Blockers', 'valsartan', 'valsartan or amlodipine', 'amlodipine']","['higher risks of myocardial infarction and stroke', 'systolic blood pressure', 'visit systolic variability', 'myocardial infarction and stroke', 'risk of congestive heart failure', 'visit-to-visit systolic variability', 'lower risk of congestive heart failure', 'blood pressure mean', 'systolic mean blood pressure', 'risk of death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0006684', 'cui_str': 'Calcium channel blocker'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}]","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",14996.0,0.0478052,"A smaller effect was seen on risk of death, from 1.01 (0.92-1.12) to 0.94 (0.85-1.04).","[{'ForeName': 'Maria H', 'Initials': 'MH', 'LastName': 'Mehlum', 'Affiliation': 'From the Department of Geriatric Medicine (M.H.M., T.B.W.), Oslo University Hospital Ullevaal, Oslo, Norway.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Liestøl', 'Affiliation': 'Department of Informatics (K.L.), University of Oslo, Norway.'}, {'ForeName': 'Sverre E', 'Initials': 'SE', 'LastName': 'Kjeldsen', 'Affiliation': 'Department of Cardiology (S.E.K., E.B.), Oslo University Hospital Ullevaal, Oslo, Norway.'}, {'ForeName': 'Torgeir B', 'Initials': 'TB', 'LastName': 'Wyller', 'Affiliation': 'From the Department of Geriatric Medicine (M.H.M., T.B.W.), Oslo University Hospital Ullevaal, Oslo, Norway.'}, {'ForeName': 'Stevo', 'Initials': 'S', 'LastName': 'Julius', 'Affiliation': 'Division of Cardiovascular Medicine, University of Michigan, Ann Arbor (S.E.K., S.J.).'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Rothwell', 'Affiliation': 'Stroke Prevention Research Unit, Nuffield Department of Clinical Neuroscience, John Radcliffe Hospital, University of Oxford, United Kingdom (P.M.R.).'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Mancia', 'Affiliation': 'Policlinico di Monza, Monza, Italy (G.M.).'}, {'ForeName': 'Gianfranco', 'Initials': 'G', 'LastName': 'Parati', 'Affiliation': 'University of Milano-Bicocca, Milan, Italy (G.M., G.P.).'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Weber', 'Affiliation': 'Department of Cardiovascular Medicine, State University of New York, Downstate College of Medicine (M.A.W.).'}, {'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Berge', 'Affiliation': 'Department of Cardiology (S.E.K., E.B.), Oslo University Hospital Ullevaal, Oslo, Norway.'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.119.14443'] 49,32398578,"The Effect of Semirecumbent and Right Lateral Positions on the Gastric Residual Volume of Mechanically Ventilated, Critically Ill Patients.","BACKGROUND Delay in stomach discharge is a challenge for patients who are tube fed and may result in serious side effects such as pneumonia and malnutrition. PURPOSE This study was designed to determine the respective effects of the semirecumbent (SR) supine and right lateral (RL) with a flatbed positions on the gastric residual volume (GRV) of mechanically ventilated, critically ill adult patients. METHODS A randomized, crossover clinical trial design was used to investigate GRV in 36 critically ill, ventilated adult patients who were hospitalized in the intensive care unit. GRV was measured at 3 hours after three consecutive feedings. GRV was first measured in all of the participants in the supine position; after which, participants were randomly assigned into one of two therapeutic positioning groups (Group A: assessment in the SR position and then the RL position; Group B: assessment in the RL position and then the SR position). RESULTS GRV was significantly lower in both the SR and RL positions than in the supine position. GRV in the SR and RL positions did not vary significantly. The in-group measurements for GRV did not significantly differ for any of the three positions. In Group A, GRV was significantly lower at each subsequent measurement point. CONCLUSION/IMPLICATIONS FOR PRACTICE Positioning patients in the RL and SR positions rather than in the supine position is an effective strategy to reduce GRV. Furthermore, placing patients in either the RL or SR position is an effective intervention to promote faster digestion and feedings.",2020,The in-group measurements for GRV did not significantly differ for any of the three positions.,"['mechanically ventilated, critically ill adult patients', 'Mechanically Ventilated, Critically Ill Patients', '36 critically ill, ventilated adult patients who were hospitalized in the intensive care unit']","['semirecumbent (SR) supine and right lateral (RL) with a flatbed positions', 'Semirecumbent and Right Lateral Positions']","['GRV', 'gastric residual volume (GRV']","[{'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0450415', 'cui_str': 'Lateral to the right'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0559228', 'cui_str': 'Right lateral decubitus position'}]","[{'cui': 'C3665864', 'cui_str': 'Gastric residual assessment'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",36.0,0.0318326,The in-group measurements for GRV did not significantly differ for any of the three positions.,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Farsi', 'Affiliation': 'PhD, Associate Professor, Faculty of Nursing, Research Department and Community Health Department, Aja University of Medical Sciences, Tehran, Iran.'}, {'ForeName': ""Maa'soumeh"", 'Initials': 'M', 'LastName': 'Kamali', 'Affiliation': 'MSc, Researcher, Student Research Committee, Faculty of Nursing, Aja University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Butler', 'Affiliation': ""PhD, Assistant Professor, Harvard Medical School and Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Zareiyan', 'Affiliation': 'PhD, Associate Professor, Faculty of Nursing, Community Health Department, Aja University of Medical Sciences, Tehran, Iran.'}]",The journal of nursing research : JNR,['10.1097/jnr.0000000000000377'] 50,32385167,"The Effects of Monosodium Glutamate on PSMA Radiotracer Uptake in Men with Recurrent Prostate Cancer: A Prospective, Randomized, Double-Blind, Placebo-Controlled Intraindividual Imaging Study.","The prostate-specific membrane antigen (PSMA) is an excellent target for theranostic applications in prostate cancer. However, PSMA-targeted radioligand therapy can cause undesirable effects due to high accumulation of PSMA radiotracers in salivary glands and kidneys. This study assessed orally administered monosodium glutamate (MSG) as a potential means of reducing kidney and salivary gland radiation exposure using a PSMA-targeting radiotracer. Methods: This prospective, double-blind, placebo-controlled study enrolled 10 patients with biochemically recurrent prostate cancer. Each subject served as his own control. PET/CT imaging sessions using 2-(3-{1-carboxy-5-[(6- 18 F-fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid ( 18 F-DCFPyL) were performed 3-7 d apart, after oral administration of either 12.7 g of MSG or placebo. Data from the 2 sets of images were analyzed by placing regions of interest on lacrimal, parotid, and submandibular glands; left ventricle; liver; spleen; kidneys; bowel; urinary bladder; gluteus muscle; and malignant lesions. The results from MSG and placebo scans were compared by paired analysis of the region-of-interest data. Results: In total, 142 pathologic lesions along with normal tissues were analyzed. As hypothesized a priori, there was a significant decrease in SUV max corrected for lean body mass (SUL max ) on images obtained after MSG administration in the parotids (24% ± 14%, P = 0.001), submandibular glands (35% ± 11%, P < 0.001), and kidneys (23% ± 26%, P = 0.014). Significant decreases were also observed in the lacrimal glands (49% ± 13%, P < 0.001), liver (15% ± 6%, P < 0.001), spleen (28% ± 13%, P = 0.001), and bowel (44% ± 13%, P < 0.001). A mildly lower blood pool SUL mean was observed after MSG administration (decrease of 11% ± 13%, P = 0.021). However, significantly lower radiotracer uptake in terms of SUL mean , SUL peak , and SUL max was observed in malignant lesions on scans performed after MSG administration than on the placebo studies (SUL max median decrease, 33%; range, -1% to 75%; P < 0.001). No significant adverse events occurred after placebo or MSG administration, and vital signs were stable. Conclusion: Orally administered MSG significantly decreased salivary gland, kidney, and other normal-organ PSMA radiotracer uptake in human subjects, using 18 F-DCFPyL as an exemplar. However, MSG caused a corresponding reduction in tumor uptake, which may limit the benefits of this approach for diagnostic and therapeutic applications.",2021,"Significant decreases were also observed in lacrimal glands (49 ± 13%, P<0.001), liver (15 ± 6%, P<0.001), spleen (28 ± 13%, P = 0.001) and bowel (44 ± 13%, P<0.001).","['controlled study enrolled 10 biochemically recurrent PCa patients', 'human subjects', 'men with recurrent prostate cancer']","['monosodium glutamate', 'placebo', 'MSG or placebo', 'monosodium glutamate (MSG', 'MSG']","['SULmean', 'Mildly lower blood pool', 'salivary gland, kidney and other normal organ PSMA radiotracer uptake', 'lacrimal glands', 'PSMA radiotracer uptake', 'maximal standardized uptake values', 'radiotracer uptake']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4759295', 'cui_str': 'Non-metastatic prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0278838', 'cui_str': 'Prostate cancer recurrent'}]","[{'cui': 'C0037511', 'cui_str': 'Monosodium glutamate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0036098', 'cui_str': 'Salivary gland structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0067685', 'cui_str': 'Glutamate carboxypeptidase II'}, {'cui': 'C0022907', 'cui_str': 'Lacrimal gland structure'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",10.0,0.296953,"Significant decreases were also observed in lacrimal glands (49 ± 13%, P<0.001), liver (15 ± 6%, P<0.001), spleen (28 ± 13%, P = 0.001) and bowel (44 ± 13%, P<0.001).","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Harsini', 'Affiliation': 'BC Cancer, Vancouver, British Columbia, Canada; and.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Saprunoff', 'Affiliation': 'BC Cancer, Vancouver, British Columbia, Canada; and.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Alden', 'Affiliation': 'BC Cancer, Vancouver, British Columbia, Canada; and.'}, {'ForeName': 'Behnoud', 'Initials': 'B', 'LastName': 'Mohammadi', 'Affiliation': 'BC Cancer, Vancouver, British Columbia, Canada; and.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Wilson', 'Affiliation': 'BC Cancer, Vancouver, British Columbia, Canada; and.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Bénard', 'Affiliation': 'BC Cancer, Vancouver, British Columbia, Canada; and fbenard@bccrc.ca.'}]","Journal of nuclear medicine : official publication, Society of Nuclear Medicine",['10.2967/jnumed.120.246983'] 51,32336038,"Safety and Efficacy of Lenabasum in a Phase II, Randomized, Placebo-Controlled Trial in Adults With Systemic Sclerosis.","OBJECTIVE To assess the safety and efficacy of lenabasum in diffuse cutaneous systemic sclerosis (dcSSc). METHODS A randomized, double-blind, placebo-controlled, phase II study was conducted at 9 SSc clinics in the US. Adults with dcSSc of ≤6 years' duration who were receiving stable standard-of-care treatment were randomized to receive lenabasum (n = 27) or placebo (n = 15). Lenabasum doses were 5 mg once daily, 20 mg once daily, or 20 mg twice daily for 4 weeks, followed by 20 mg twice daily for 8 weeks. Safety and efficacy were assessed at weeks 4, 8, 12, and 16. RESULTS Adverse events (AEs) occurred in 63% of the lenabasum group and 60% of the placebo group, with no serious AEs related to lenabasum. Compared to placebo, lenabasum treatment was associated with greater improvement in the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) score and other efficacy outcome measures that assessed overall disease, skin involvement, and patient-reported function. The median CRISS score increased in the lenabasum group during the study, reaching 0.33, versus 0.00 in the placebo group, at week 16 (P = 0.07 by 2-sided mixed-effects model repeated-measures analysis). Gene expression in inflammation and fibrosis pathways was reduced, and inflammation and fibrosis were improved on histologic evaluation of skin biopsy specimens, in the lenabasum group compared to the placebo group (all P ≤ 0.05). CONCLUSION Despite a short trial duration in a small number of patients in this phase II study in dcSSc, our findings indicate that lenabasum improves efficacy outcomes and underlying disease pathology with a favorable safety profile.",2020,"Lenabasum treatment compared to placebo was associated with greater improvement in American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) score and other efficacy outcomes that assessed overall disease, skin involvement, and patient-reported function.","['Adults with dcSSc ≤ 6 years duration on stable standard-of-care treatment received lenabasum (N = 27) or', 'adults with systemic sclerosis', 'diffuse cutaneous systemic sclerosis (dcSSc', 'nine SSc clinics in the USA']","['placebo', 'lenabasum']","['American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) score', 'Safety and efficacy', 'Gene expression in inflammation and fibrosis pathways', 'Adverse events', 'CRISS score', 'Safety and efficacy assessments']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1258104', 'cui_str': 'Progressive systemic sclerosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1258104', 'cui_str': 'Progressive systemic sclerosis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.474232,"Lenabasum treatment compared to placebo was associated with greater improvement in American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) score and other efficacy outcomes that assessed overall disease, skin involvement, and patient-reported function.","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Spiera', 'Affiliation': 'Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hummers', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Lorinda', 'Initials': 'L', 'LastName': 'Chung', 'Affiliation': 'Stanford University School of Medicine, Stanford, California, and Palo Alto VA Health Care System, Palo Alto, California.'}, {'ForeName': 'Tracy M', 'Initials': 'TM', 'LastName': 'Frech', 'Affiliation': 'University of Utah, and Salt Lake City VA Health Care System.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Domsic', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Vivien', 'Initials': 'V', 'LastName': 'Hsu', 'Affiliation': 'Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Furst', 'Affiliation': 'Arthritis Association of Southern California, Los Angeles, California.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Gordon', 'Affiliation': 'Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Mayes', 'Affiliation': 'University of Texas Health Science Center at Houston.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Simms', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lafyatis', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Martyanov', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.'}, {'ForeName': 'Tammara', 'Initials': 'T', 'LastName': 'Wood', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Whitfield', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Constantine', 'Affiliation': 'Corbus Pharmaceuticals, Norwood, Massachusetts.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': 'Corbus Pharmaceuticals, Norwood, Massachusetts.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Dgetluck', 'Affiliation': 'Corbus Pharmaceuticals, Norwood, Massachusetts.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'White', 'Affiliation': 'Corbus Pharmaceuticals, Norwood, Massachusetts.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41294'] 52,31923712,Late toxicity and quality of life with prostate only or whole pelvic radiation therapy in high risk prostate cancer (POP-RT): A randomised trial.,"AIM To report toxicity and quality of life (QOL) outcomes from a randomised trial of prostate only versus whole pelvic radiotherapy in high risk, node negative prostate cancer. MATERIALS/METHODS Patients with localised prostate adenocarcinoma and nodal involvement risk > 20%, were randomised to prostate only (PORT, 68 Gy/25# to prostate) and whole pelvis (WPRT, 68 Gy/25# to prostate and 50 Gy/25# to pelvis) arms with stratification for TURP, Gleason score, baseline PSA, and type of androgen deprivation therapy (ADT). Image guided intensity modulated radiotherapy (IG-IMRT) and two years of ADT were mandatory. Acute and late genitourinary (GU) and gastrointestinal (GI) toxicities were graded using RTOG grading. QOL was assessed using EORTC QLQ-C30 and PR-25 questionnaire pre-treatment and every 3-6 months post RT. RESULTS Total 224 patients were randomised (PORT 114, WPRT 110) from November 2011 to August 2017. Median follow up was 44.5 months. No RTOG grade IV toxicity was observed. Acute GI and GU toxicities were similar between both the arms. Cumulative ≥ grade II late GI toxicity was similar for WPRT and PORT (6.5% vs. 3.8%, p = 0.39) but GU toxicity was higher (17.7% vs. 7.5%, p = 0.03). Dosimetric analysis showed higher bladder volume receiving 30-40 Gy in the WPRT arm (V30, 60% vs. 36%, p < 0.001; V40, 41% vs. 25%, p < 0.001). There was no difference in QOL scores of any domain between both arms. CONCLUSION Pelvic irradiation using hypofractionated IG-IMRT resulted in increased grade II or higher late genitourinary toxicity as compared to prostate only RT, but the difference was not reflected in patient reported QOL. CLINICALTRIALS.GOV NCT02302105: Prostate Only or Whole Pelvic Radiation Therapy in High Risk Prostate Cancer (POP-RT).",2020,"CONCLUSION Pelvic irradiation using hypofractionated IG-IMRT resulted in increased grade II or higher late genitourinary toxicity as compared to prostate only RT, but the difference was not reflected in patient reported QOL.","['high risk prostate cancer (POP-RT', 'Patients with localised prostate adenocarcinoma and nodal involvement risk', 'High Risk Prostate Cancer (POP-RT', 'Total 224 patients were randomised (PORT 114, WPRT 110) from November 2011 to August 2017']","['Prostate Only or Whole Pelvic Radiation Therapy', 'prostate only versus whole pelvic radiotherapy', 'Image guided intensity modulated radiotherapy (IG-IMRT', 'prostate only or whole pelvic radiation therapy']","['No RTOG grade IV toxicity', 'QOL', 'Late toxicity and quality of life', 'bladder volume', 'GU toxicity', 'Cumulative\xa0≥\xa0grade II late GI toxicity', 'grade II or higher late genitourinary toxicity', 'TURP, Gleason score, baseline PSA, and type of androgen deprivation therapy (ADT', 'QOL scores', 'Acute and late genitourinary (GU) and gastrointestinal (GI) toxicities', 'Acute GI and GU toxicities', 'toxicity and quality of life (QOL) outcomes']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}]","[{'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1512814', 'cui_str': 'Radiotherapy, Intensity-Modulated'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0429770', 'cui_str': 'Bladder volume (observable entity)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0040771', 'cui_str': 'Prostatectomy, Transurethral'}, {'cui': 'C3203027', 'cui_str': 'Gleason score (observable entity)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}]",224.0,0.216113,"CONCLUSION Pelvic irradiation using hypofractionated IG-IMRT resulted in increased grade II or higher late genitourinary toxicity as compared to prostate only RT, but the difference was not reflected in patient reported QOL.","[{'ForeName': 'Vedang', 'Initials': 'V', 'LastName': 'Murthy', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Hospital and Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Homi Bhabha National Institute (HBNI), Mumbai, India. Electronic address: vmurthy@actrec.gov.in.'}, {'ForeName': 'Priyamvada', 'Initials': 'P', 'LastName': 'Maitre', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Hospital and Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Jatin', 'Initials': 'J', 'LastName': 'Bhatia', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Hospital and Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Sadhana', 'Initials': 'S', 'LastName': 'Kannan', 'Affiliation': 'Department of Biostatistics, Tata Memorial Hospital and Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Krishnatry', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Hospital and Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Gagan', 'Initials': 'G', 'LastName': 'Prakash', 'Affiliation': 'Department of Uro-Oncology, Tata Memorial Hospital and Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Bakshi', 'Affiliation': 'Department of Uro-Oncology, Tata Memorial Hospital and Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Mahendra', 'Initials': 'M', 'LastName': 'Pal', 'Affiliation': 'Department of Uro-Oncology, Tata Memorial Hospital and Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Santosh', 'Initials': 'S', 'LastName': 'Menon', 'Affiliation': 'Department of Pathology, Tata Memorial Hospital and Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Umesh', 'Initials': 'U', 'LastName': 'Mahantshetty', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Hospital and Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Homi Bhabha National Institute (HBNI), Mumbai, India.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2019.12.006'] 53,32219386,Effect of Dapagliflozin on Worsening Heart Failure and Cardiovascular Death in Patients With Heart Failure With and Without Diabetes.,"Importance Additional treatments are needed for heart failure with reduced ejection fraction (HFrEF). Sodium-glucose cotransporter 2 (SGLT2) inhibitors may be an effective treatment for patients with HFrEF, even those without diabetes. Objective To evaluate the effects of dapagliflozin in patients with HFrEF with and without diabetes. Design, Setting, and Participants Exploratory analysis of a phase 3 randomized trial conducted at 410 sites in 20 countries. Patients with New York Heart Association classification II to IV with an ejection fraction less than or equal to 40% and elevated plasma N-terminal pro B-type natriuretic peptide were enrolled between February 15, 2017, and August 17, 2018, with final follow-up on June 6, 2019. Interventions Addition of once-daily 10 mg of dapagliflozin or placebo to recommended therapy. Main Outcomes and Measures The primary outcome was the composite of an episode of worsening heart failure or cardiovascular death. This outcome was analyzed by baseline diabetes status and, in patients without diabetes, by glycated hemoglobin level less than 5.7% vs greater than or equal to 5.7%. Results Among 4744 patients randomized (mean age, 66 years; 1109 [23%] women; 2605 [55%] without diabetes), 4742 completed the trial. Among participants without diabetes, the primary outcome occurred in 171 of 1298 (13.2%) in the dapagliflozin group and 231 of 1307 (17.7%) in the placebo group (hazard ratio, 0.73 [95% CI, 0.60-0.88]). In patients with diabetes, the primary outcome occurred in 215 of 1075 (20.0%) in the dapagliflozin group and 271 of 1064 (25.5%) in the placebo group (hazard ratio, 0.75 [95% CI, 0.63-0.90]) (P value for interaction = .80). Among patients without diabetes and a glycated hemoglobin level less than 5.7%, the primary outcome occurred in 53 of 438 patients (12.1%) in the dapagliflozin group and 71 of 419 (16.9%) in the placebo group (hazard ratio, 0.67 [95% CI, 0.47-0.96]). In patients with a glycated hemoglobin of at least 5.7%, the primary outcome occurred in 118 of 860 patients (13.7%) in the dapagliflozin group and 160 of 888 (18.0%) in the placebo group (hazard ratio, 0.74 [95% CI, 0.59-0.94]) (P value for interaction = .72). Volume depletion was reported as an adverse event in 7.3% of patients in the dapagliflozin group and 6.1% in the placebo group among patients without diabetes and in 7.8% of patients in the dapagliflozin group and 7.8% in the placebo group among patients with diabetes. A kidney adverse event was reported in 4.8% of patients in the dapagliflozin group and 6.0% in the placebo group among patients without diabetes and in 8.5% of patients in the dapagliflozin group and 8.7% in the placebo group among patients with diabetes. Conclusions and Relevance In this exploratory analysis of a randomized trial of patients with HFrEF, dapagliflozin compared with placebo, when added to recommended therapy, significantly reduced the risk of worsening heart failure or cardiovascular death independently of diabetes status. Trial Registration ClinicalTrials.gov Identifier: NCT03036124.",2020,Volume depletion was reported as an adverse event in 7.3% of patients in the dapagliflozin group and 6.1% in the placebo group among patients without diabetes and in 7.8% of patients in the dapagliflozin group and 7.8% in the placebo group among patients with diabetes.,"['than 5.7% vs greater than or equal to 5.7', 'Patients With Heart Failure', '4744 patients randomized (mean age, 66 years; 1109 [23%] women; 2605 [55%] without diabetes), 4742 completed the trial', 'patients with', 'Participants\n\n\nExploratory analysis of a phase 3 randomized trial conducted at 410 sites in 20 countries', 'patients with HFrEF with and without diabetes', 'patients with HFrEF, even those without diabetes', 'Patients with New York Heart Association classification II to IV with an ejection fraction less than or equal to 40% and elevated plasma N-terminal pro B-type natriuretic peptide were enrolled between February 15, 2017, and August 17, 2018, with final follow-up on June 6, 2019']","['HFrEF, dapagliflozin', 'Dapagliflozin', 'placebo', 'dapagliflozin or placebo', 'dapagliflozin', 'Sodium-glucose cotransporter 2 (SGLT2) inhibitors']","['glycated hemoglobin', 'adverse event', 'glycated hemoglobin level less', 'kidney adverse event', 'risk of worsening heart failure or cardiovascular death independently of diabetes status', 'composite of an episode of worsening heart failure or cardiovascular death', 'Volume depletion', 'glycated hemoglobin level', 'Worsening Heart Failure and Cardiovascular Death']","[{'cui': 'C4517795', 'cui_str': 'Five point seven'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0546884', 'cui_str': 'Hypovolemia'}]",4744.0,0.292236,Volume depletion was reported as an adverse event in 7.3% of patients in the dapagliflozin group and 6.1% in the placebo group among patients without diabetes and in 7.8% of patients in the dapagliflozin group and 7.8% in the placebo group among patients with diabetes.,"[{'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Petrie', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Kieran F', 'Initials': 'KF', 'LastName': 'Docherty', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Inder', 'Initials': 'I', 'LastName': 'Anand', 'Affiliation': 'Department of Cardiology, University of Minnesota, Minneapolis.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Belohlávek', 'Affiliation': 'Second Department of Internal Medicine, Cardiovascular Medicine, General Teaching Hospital, First Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Department of Medicine, Saarland University Hospital, Homburg/Saar, Germany.'}, {'ForeName': 'Chern-En', 'Initials': 'CE', 'LastName': 'Chiang', 'Affiliation': 'Division of Cardiology, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Vijay K', 'Initials': 'VK', 'LastName': 'Chopra', 'Affiliation': 'Department of Cardiology, Medanta, Gurgaon, Haryana, India.'}, {'ForeName': 'Rudolf A', 'Initials': 'RA', 'LastName': 'de Boer', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Akshay S', 'Initials': 'AS', 'LastName': 'Desai', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Mirta', 'Initials': 'M', 'LastName': 'Diez', 'Affiliation': 'Division of Cardiology, Instituto Cardiovascular de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Jaroslaw', 'Initials': 'J', 'LastName': 'Drozdz', 'Affiliation': 'Department Cardiology, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Dukát', 'Affiliation': 'Fifth Department of Internal Medicine, Comenius University in Bratislava, Bratislava, Slovakia.'}, {'ForeName': 'Junbo', 'Initials': 'J', 'LastName': 'Ge', 'Affiliation': 'Shanghai Institute of Cardiovascular Disease, Department of Cardiology, Zhongshan Hospital Fudan University, Shanghai, China.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Howlett', 'Affiliation': 'Libin Cardiovascular Institute, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Tzvetana', 'Initials': 'T', 'LastName': 'Katova', 'Affiliation': 'Clinic of Cardiology, National Cardiology Hospital, Sofia, Bulgaria.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Kitakaze', 'Affiliation': 'Cardiovascular Division of Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Charlotta E A', 'Initials': 'CEA', 'LastName': 'Ljungman', 'Affiliation': 'Institute of Medicine, Department of Molecular and Clinical Medicine/Cardiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Béla', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clínicas Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': ""O'Meara"", 'Affiliation': 'Department of Cardiology, Montreal Heart Institute, Montreal, Ontario, Canada.'}, {'ForeName': 'Pham Nguyen', 'Initials': 'PN', 'LastName': 'Vinh', 'Affiliation': 'Department of Internal Medicine, Tan Tao University, Tan Duc, Vietnam.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Schou', 'Affiliation': 'Department of Cardiology, Gentofte University Hospital Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Tereshchenko', 'Affiliation': 'Department of Myocardial Disease and Heart Failure, National Medical Research Center of Cardiology, Moscow, Russia.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""St Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City.""}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Martinez', 'Affiliation': 'Universidad Nacional de Córdoba, Córdoba, Argentina.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Center for Heart Diseases, University Hospital, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Sjöstrand', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Johanson', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Greasley', 'Affiliation': 'Early Discovery and Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Boulton', 'Affiliation': 'Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Bengtsson', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}]",JAMA,['10.1001/jama.2020.1906'] 54,32234739,Assessing efficacy of CytoSorb haemoadsorber for prevention of organ dysfunction in cardiac surgery patients with infective endocarditis: REMOVE-protocol for randomised controlled trial.,"INTRODUCTION Infective endocarditis (IE) is associated with high mortality and morbidity. Multiple organ failure is the main cause of death after surgery for IE. Cardiopulmonary bypass (CPB) can cause a systemic inflammatory response. In a pilot study (REMOVE-pilot (Revealing mechanisms and investigating efficacy of hemoad-sorption for prevention of vasodilatory shock in cardiac surgery patients with infective endocarditis - a multicentric randomized controlled group sequential trial)), we found that plasma profiles of cytokines during and after CPB were higher in patients with IE compared with patients with non-infectious valvular heart disease. Sequential Organ Failure Assessment (SOFA) scores on the first and second postoperative days and in-hospital mortality were also higher in IE patients. This protocol describes the design of the REMOVE trial on cytokine-adsorbing columns, for example, CytoSorb, for non-selective removal of cytokines. The aim of the REMOVE study is to demonstrate efficacy of CytoSorb on the prevention of multiorgan dysfunction in patients with IE undergoing cardiac surgery. METHODS AND ANALYSIS The REMOVE study is an interventional randomised controlled multicenter trial with a group sequential (Pocock) design for assessing efficacy of CytoSorb in patients undergoing cardiac surgery for IE. The change in mean total SOFA (∆ SOFA) score between preoperative and postoperative care will be used as primary endpoint. Data on 30-day mortality, changes in cytokines levels, duration of mechanical ventilation, length of intensive care unit and hospital stay, and postoperative stroke will be collected as secondary endpoints. An interim analysis will be conducted after including 25 participating patients per study arm (with a focus on feasibility of the recruitment as well as differences in cytokines and cell-free DNA levels). ETHICS AND DISSEMINATION The protocol was approved by the institutional review board and ethics committee of the University of Jena as well as by the corresponding ethics committee of each participating study centre. The results will be published in a renowned international medical journal, irrespective of the outcomes of the study. TRIAL REGISTRATION NUMBER The ClinicalTrials.gov registry (NCT03266302).",2020,Sequential Organ Failure Assessment (SOFA) scores on the first and second postoperative days and in-hospital mortality were also higher in IE patients.,"['cardiac surgery patients with infective endocarditis ', 'patients with IE compared with patients with non-infectious valvular heart disease', 'patients undergoing cardiac surgery for IE', 'patients with IE undergoing cardiac surgery', 'cardiac surgery patients with infective endocarditis']","['Cardiopulmonary bypass (CPB', 'hemoad-sorption', 'CytoSorb', 'CytoSorb haemoadsorber']","['cytokines and cell-free DNA levels', 'hospital mortality', '30-day mortality, changes in cytokines levels, duration of mechanical ventilation, length of intensive care unit and hospital stay, and postoperative stroke', 'mean total SOFA (∆ SOFA) score', 'multiorgan dysfunction', 'Sequential Organ Failure Assessment (SOFA) scores']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014121', 'cui_str': 'Bacterial endocarditis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0018824', 'cui_str': 'Heart valve disorder'}]","[{'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C4289789', 'cui_str': 'Cell free DNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}]",25.0,0.305827,Sequential Organ Failure Assessment (SOFA) scores on the first and second postoperative days and in-hospital mortality were also higher in IE patients.,"[{'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Diab', 'Affiliation': 'Department of Cardiothoracic Surgery, Jena University Hospital - Friedrich Schiller University of Jena, Jena, Thuringia, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Platzer', 'Affiliation': 'Center for Sepsis Control and Care, Jena University Hospital - Friedrich Schiller University, Jena, Thuringia, Germany.'}, {'ForeName': 'Albrecht', 'Initials': 'A', 'LastName': 'Guenther', 'Affiliation': 'Department of Neurology, Jena University Hospital - Friedrich Schiller University of Jena, Jena, Thuringia, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Sponholz', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, Jena University Hospital - Friedrich Schiller University of Jena, Jena, Thuringia, Germany.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Scherag', 'Affiliation': 'Center for Sepsis Control and Care, Jena University Hospital - Friedrich Schiller University, Jena, Thuringia, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lehmann', 'Affiliation': 'Center for Sepsis Control and Care, Jena University Hospital - Friedrich Schiller University, Jena, Thuringia, Germany.'}, {'ForeName': 'Ilia', 'Initials': 'I', 'LastName': 'Velichkov', 'Affiliation': 'Department of Cardiothoracic Surgery, Jena University Hospital - Friedrich Schiller University of Jena, Jena, Thuringia, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Hagel', 'Affiliation': 'Center for Sepsis Control and Care, Jena University Hospital - Friedrich Schiller University, Jena, Thuringia, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bauer', 'Affiliation': 'Center for Sepsis Control and Care, Jena University Hospital - Friedrich Schiller University, Jena, Thuringia, Germany.'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Brunkhorst', 'Affiliation': 'Center for Sepsis Control and Care, Jena University Hospital - Friedrich Schiller University, Jena, Thuringia, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Doenst', 'Affiliation': 'Department of Cardiothoracic Surgery, Jena University Hospital - Friedrich Schiller University of Jena, Jena, Thuringia, Germany Doenst@med.uni-jena.de.'}]",BMJ open,['10.1136/bmjopen-2019-031912'] 55,32299241,"Effects of acupuncture on anthropometric and serum metabolic parameters in premenopausal overweight and obese women: a randomized, patient- and assessor-blind, sham-controlled clinical trial.","OBJECTIVE The aim of this study was to examine the effect of acupuncture on obesity-related parameters with regard to metabolomics. METHODS This two-arm parallel, patient- and assessor-blind, sham-controlled randomized clinical trial included 120 obese participants. Participants were randomized into two groups. The treatment group received a combined intervention of manual acupuncture (MA) plus electroacupuncture (EA), while the control group received a combination of sham acupuncture interventions consisting of sham MA plus sham EA for 6 weeks. The serum lipid levels were measured as the primary outcome measure and anthropometric parameters and serum metabolic profiles including amino acids and carnitines were measured as secondary outcome measures. RESULTS The serum lipid levels and anthropometric measurements did not significantly differ between groups, while body weight, body mass index (BMI), and waist circumference were improved within each group and the level of high-density lipoprotein cholesterol increased over time in the treatment group. There were no significant differences in amino acid levels between groups, while certain carnitine (C2, C4, C6, and l-carnitine) levels were significantly increased ( p  < 0.05) in the treatment group compared to the control group. CONCLUSION In summary, 6 weeks of acupuncture treatment did not affect anthropometric and serum metabolic parameters, with the exception of certain carnitines, when compared to sham acupuncture. The observation of increased carnitine levels in the acupuncture group could result in potential long-term benefits to obese individuals. Additional studies are needed to investigate the long-term effects of acupuncture on lipid metabolism and the underlying mechanism of action. TRIAL REGISTRATION NUMBER This study is registered at ClinicalTrials.gov (NCT02066090).",2021,"There were no significant differences in amino acid levels between groups, while certain carnitine (C2, C4, C6, and l-carnitine) levels were significantly increased ( p  < 0.05) in the treatment group compared to the control group. ","['premenopausal overweight and obese women', '120 obese participants']","['acupuncture', 'combined intervention of manual acupuncture (MA) plus electroacupuncture (EA), while the control group received a combination of sham acupuncture interventions consisting of sham MA plus sham EA']","['level of high-density lipoprotein cholesterol', 'anthropometric and serum metabolic parameters', 'serum lipid levels and anthropometric measurements', 'anthropometric parameters and serum metabolic profiles including amino acids and carnitines', 'certain carnitine (C2, C4, C6, and l-carnitine) levels', 'serum lipid levels', 'body weight, body mass index (BMI), and waist circumference', 'carnitine levels', 'amino acid levels']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0007258', 'cui_str': 'Carnitine'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0087163', 'cui_str': 'Levocarnitine'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C1328436', 'cui_str': 'Amino acid level'}]",120.0,0.348525,"There were no significant differences in amino acid levels between groups, while certain carnitine (C2, C4, C6, and l-carnitine) levels were significantly increased ( p  < 0.05) in the treatment group compared to the control group. ","[{'ForeName': 'Koh-Woon', 'Initials': 'KW', 'LastName': 'Kim', 'Affiliation': 'Department of Korean Rehabilitation Medicine, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Woo-Chul', 'Initials': 'WC', 'LastName': 'Shin', 'Affiliation': 'Department of Korean Rehabilitation Medicine, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Min Sun', 'Initials': 'MS', 'LastName': 'Choi', 'Affiliation': 'Institute of Pharmaceutical Science and Technology and College of Pharmacy, Hanyang University, Ansan, Republic of Korea.'}, {'ForeName': 'Jae-Heung', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': 'Department of Korean Rehabilitation Medicine, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Hi-Joon', 'Initials': 'HJ', 'LastName': 'Park', 'Affiliation': 'Department of Science in Korean Medicine, College of Korean Medicine, Graduate School, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Hye Hyun', 'Initials': 'HH', 'LastName': 'Yoo', 'Affiliation': 'Institute of Pharmaceutical Science and Technology and College of Pharmacy, Hanyang University, Ansan, Republic of Korea.'}, {'ForeName': 'Mi-Yeon', 'Initials': 'MY', 'LastName': 'Song', 'Affiliation': 'Department of Korean Rehabilitation Medicine, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1177/0964528420912259'] 56,32300129,Mindfulness Meditation Activates Altruism.,"Clinical evidence suggests that mindfulness meditation reduces anxiety, depression, and stress, and improves emotion regulation due to modulation of activity in neural substrates linked to the regulation of emotions and social preferences. However, less was known about whether mindfulness meditation might alter pro-social behavior. Here we examined whether mindfulness meditation activates human altruism, a component of social cooperation. Using a simple donation game, which is a real-world version of the Dictator's Game, we randomly assigned 326 subjects to a mindfulness meditation online session or control and measured their willingness to donate a portion of their payment for participation as a charitable donation. Subjects who underwent the meditation treatment donated at a 2.61 times higher rate than the control (p = 0.005), after controlling for socio-demographics. We also found a larger treatment effect of meditation among those who did not go to college (p < 0.001) and those who were under 25 years of age (p < 0.001), with both subject groups contributing virtually nothing in the control condition. Our results imply high context modularity of human altruism and the development of intervention approaches including mindfulness meditation to increase social cooperation, especially among subjects with low baseline willingness to contribute.",2020,"Subjects who underwent the meditation treatment donated at a 2.61 times higher rate than the control (p = 0.005), after controlling for socio-demographics.",['326 subjects to a'],"['mindfulness meditation online session or control and measured their willingness to donate a portion of their payment for participation as a charitable donation', 'mindfulness meditation']","['anxiety, depression, and stress, and improves emotion regulation']","[{'cui': 'C5191353', 'cui_str': '326'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",326.0,0.0125002,"Subjects who underwent the meditation treatment donated at a 2.61 times higher rate than the control (p = 0.005), after controlling for socio-demographics.","[{'ForeName': 'Sage K', 'Initials': 'SK', 'LastName': 'Iwamoto', 'Affiliation': 'College of Letters & Sciences, UC Berkeley, Berkeley, CA, 94720, United States.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Alexander', 'Affiliation': 'Human Nature Lab, Yale Institute for Network Science, Yale University, New Haven, CT, 06514, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Torres', 'Affiliation': 'Human Nature Lab, Yale Institute for Network Science, Yale University, New Haven, CT, 06514, United States.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Irwin', 'Affiliation': 'Mindful Awareness Research Center and Cousins Center for Psychoneuroimmunology, Jane and Terry Semel Institute for Neuroscience at UCLA, and Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, Los Angeles, CA, 90095, United States.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Christakis', 'Affiliation': 'Human Nature Lab, Yale Institute for Network Science, Yale University, New Haven, CT, 06514, United States.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Nishi', 'Affiliation': 'Department of Epidemiology, UCLA Fielding School of Public Health, Los Angeles, CA, 90095, United States. akihironishi@ucla.edu.'}]",Scientific reports,['10.1038/s41598-020-62652-1'] 57,32323190,Associations between model-predicted rivaroxaban exposure and patient characteristics and efficacy and safety outcomes in the prevention of venous thromboembolism.,"Anticoagulant plasma concentrations and patient characteristics might affect the benefit-risk balance of therapy. The study objective was to assess the impact of model-predicted rivaroxaban exposure and patient characteristics on outcomes in patients receiving rivaroxaban for venous thromboembolism (VTE) prophylaxis (VTE-P) after hip/knee replacement surgery. Post hoc exposure-response analyses were conducted using data from the phase 3 RECORD1-4 studies, in which 12,729 patients were randomized to rivaroxaban 10 mg once daily or enoxaparin for ≤ 39 days. Multivariate regression approaches were used to correlate model-predicted individual rivaroxaban exposures and patient characteristics with outcomes. In the absence of measured rivaroxaban exposure, exposure estimates were predicted based on individual increases in prothrombin time (PT) and by making use of the known correlation between rivaroxaban plasma concentration and dynamics of PT. No significant associations between rivaroxaban exposure and total VTE or major bleeding were identified. A significant association between exposure and a composite of major or non-major clinically relevant (NMCR) bleeding from day 4 after surgery was observed. The relationship was shallow, with an approximate predicted absolute increase in a composite of major or NMCR bleeding from 1.08 [95% confidence interval (CI) 0.76-1.54] to 2.18% (95% CI 1.51-3.17) at the 5th and 95th percentiles of trough plasma concentration, respectively. In conclusion, based on the underlying data and analysis, no reliable target window for exposure with improved benefit-risk could be identified within the investigated exposure range. Hence, monitoring rivaroxaban levels is unlikely to be beneficial in VTE-P.",2020,No significant associations between rivaroxaban exposure and total VTE or major bleeding were identified.,"['12,729 patients', 'patients receiving rivaroxaban for venous thromboembolism (VTE) prophylaxis (VTE-P) after hip/knee replacement surgery']","['rivaroxaban', 'rivaroxaban 10\xa0mg once daily or enoxaparin']","['composite of major or NMCR bleeding', 'prothrombin time (PT', 'rivaroxaban exposure and total VTE or major bleeding', 'composite of major or non-major clinically relevant (NMCR) bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C3162455', 'cui_str': 'rivaroxaban 10 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}]",12729.0,0.076615,No significant associations between rivaroxaban exposure and total VTE or major bleeding were identified.,"[{'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Reinecke', 'Affiliation': 'Bayer AB, Solna, Sweden.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Solms', 'Affiliation': 'Clinical Pharmacometrics, Bayer AG, Berlin, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Willmann', 'Affiliation': 'Clinical Pharmacometrics, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Theodore E', 'Initials': 'TE', 'LastName': 'Spiro', 'Affiliation': 'Bayer U.S., LLC, Research & Development, Pharmaceuticals, 100 Bayer Boulevard, Whippany, NJ, 07981, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Peters', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Jeffrey I', 'Initials': 'JI', 'LastName': 'Weitz', 'Affiliation': 'McMaster University, and the Thrombosis & Atherosclerosis Research Institute, Hamilton, ON, Canada.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Mueck', 'Affiliation': 'Clinical Pharmacokinetics, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Garmann', 'Affiliation': 'Clinical Pharmacometrics, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': 'Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, FL, USA.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Keith A A', 'Initials': 'KAA', 'LastName': 'Fox', 'Affiliation': 'Centre for Cardiovascular Science, The University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Bayer U.S., LLC, Research & Development, Pharmaceuticals, 100 Bayer Boulevard, Whippany, NJ, 07981, USA. scott.berkowitz@bayer.com.'}]",Journal of thrombosis and thrombolysis,['10.1007/s11239-020-02078-8'] 58,32145827,"Treatment of advanced AIDS-associated Kaposi sarcoma in resource-limited settings: a three-arm, open-label, randomised, non-inferiority trial.","BACKGROUND Optimal treatment regimens for AIDS-associated Kaposi sarcoma, a frequent contributor to morbidity and mortality among people with HIV, have not been systematically evaluated in low-income and middle-income countries, where the disease is most common. In this study, we aimed to investigate optimal treatment strategies for advanced stage disease in areas of high prevalence and limited resources. METHODS In this open-label, non-inferiority trial, we enrolled people with HIV and advanced stage AIDS-associated Kaposi sarcoma attending 11 AIDS Clinical Trials Group sites in Brazil, Kenya, Malawi, South Africa, Uganda, and Zimbabwe. Eligible participants were randomly assigned (1:1:1) with a centralised computer system to receive either intravenous bleomycin and vincristine or oral etoposide (the investigational arms), or intravenous paclitaxel (the control arm), together with antiretroviral therapy (ART; combined efavirenz, tenofovir disoproxil fumarate, and emtricitabine). The primary outcome was progression-free survival (PFS) at week 48, using a 15% non-inferiority margin to compare the investigational groups against the active control group. Safety was assessed in all eligible treated study participants. The study was registered with ClinicalTrials.gov, NCT01435018. FINDINGS 334 participants were enrolled between Oct 1, 2013, and March 8, 2018, when the study was closed early due to inferiority of the bleomycin and vincristine plus ART arm, as per the recommendations of the Data and Safety Monitoring Board (DSMB). The etoposide plus ART arm also closed due to inferiority in March, 2016, following a DSMB recommendation. Week-48 PFS rates were higher in the paclitaxel plus ART arm than in both investigational arms. The absolute differences in PFS were -30% (95% CI -52 to -8) for the comparison of paclitaxel plus ART (week 48 PFS 50%, 32 to 67; n=59) and etoposide plus ART (20%, 6 to 33; n=59), and -20% (-33% to -7%) for the comparison of paclitaxel plus ART (64%, 55 to 73; n=138) and bleomycin and vincristine plus ART (44%, 35 to 53; n=132). Both CIs overlapped the non-inferiority margin. The most common adverse events, in 329 eligible participants who began treatment, were neutropenia (48 [15%]), low serum albumin (33 [10%]), weight loss (29 [9%]), and anaemia (28 [9%]), occurring at similar frequency across treatment arms. INTERPRETATION Non-inferiority of either investigational intervention was not shown, with paclitaxel plus ART showing superiority to both oral etoposide plus ART and bleomycin and vincristine plus ART, supporting its use in treating advanced AIDS-associated Kaposi sarcoma in resource-limited settings. FUNDING US National Institute of Allergy and Infectious Diseases and National Cancer Institute, National Institutes of Health.",2020,"The primary outcome was progression-free survival (PFS) at week 48, using a 15% non-inferiority margin to compare the investigational groups against the active control group.","['334 participants were enrolled between Oct 1, 2013, and March 8, 2018, when the study was closed early due to inferiority of the', 'people with HIV', 'enrolled people with HIV and advanced stage AIDS-associated Kaposi sarcoma attending 11 AIDS Clinical Trials Group sites in Brazil, Kenya, Malawi, South Africa, Uganda, and Zimbabwe', 'advanced stage disease in areas of high prevalence and limited resources', 'Eligible participants']","['antiretroviral therapy (ART; combined efavirenz, tenofovir disoproxil fumarate, and emtricitabine', 'paclitaxel plus ART', 'etoposide plus ART', 'intravenous bleomycin and vincristine or oral etoposide (the investigational arms), or intravenous paclitaxel', 'bleomycin and vincristine plus ART']","['progression-free survival (PFS', 'low serum albumin', 'weight loss', 'neutropenia', 'PFS', 'Safety', 'Week-48 PFS rates']","[{'cui': 'C4517729', 'cui_str': '334'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0036220', 'cui_str': 'Kaposi Sarcoma'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1320290', 'cui_str': 'Clinical trial group'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0043476', 'cui_str': 'Southern Rhodesia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum (procedure)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]",329.0,0.329646,"The primary outcome was progression-free survival (PFS) at week 48, using a 15% non-inferiority margin to compare the investigational groups against the active control group.","[{'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Krown', 'Affiliation': 'AIDS Malignancy Consortium, New York, NY, USA. Electronic address: krowns@mskcc.org.'}, {'ForeName': 'Carlee B', 'Initials': 'CB', 'LastName': 'Moser', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T H Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'MacPhail', 'Affiliation': 'Clinical HIV Research Unit, Department of Internal Medicine, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Roy M', 'Initials': 'RM', 'LastName': 'Matining', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T H Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Godfrey', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Stephanie R', 'Initials': 'SR', 'LastName': 'Caruso', 'Affiliation': 'Frontier Science Foundation, Amherst, NY, USA.'}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': 'UNC Project-Malawi, Lilongwe, Malawi; Department of Medicine, University of North Carolina at Chapel Hill School of Medicine, Division of Infectious Diseases, Chapel Hill, NC, USA.'}, {'ForeName': 'Wadzanai', 'Initials': 'W', 'LastName': 'Samaneka', 'Affiliation': 'Parirenyatwa Clinical Research Site, Harare, Zimbabwe.'}, {'ForeName': 'Mulinda', 'Initials': 'M', 'LastName': 'Nyirenda', 'Affiliation': 'Johns Hopkins Research Project, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Naftali W', 'Initials': 'NW', 'LastName': 'Busakhala', 'Affiliation': 'Moi University School of Medicine, Eldoret, Kenya.'}, {'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Okuku', 'Affiliation': 'Uganda Cancer Institute, Kampala, Uganda.'}, {'ForeName': 'Josphat', 'Initials': 'J', 'LastName': 'Kosgei', 'Affiliation': 'Kenya Medical Research Institute, USA Medical Directorate for Africa/Kenya, Kericho, Kenya.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Hoagland', 'Affiliation': 'Oswaldo Cruz Foundation, Evandro Chagas National Institute of Infectious Diseases, Rio de Janeiro, Brazil.'}, {'ForeName': 'Noluthando', 'Initials': 'N', 'LastName': 'Mwelase', 'Affiliation': 'Clinical HIV Research Unit, Department of Internal Medicine, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Vincent O', 'Initials': 'VO', 'LastName': 'Oliver', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, Centers for Disease Control and Prevention, Kisumu CRS, HIV-Research Branch, Kisumu, Kenya.'}, {'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Burger', 'Affiliation': 'Family Clinical Research Unit CRS, Stellenbosch University and Tygerberg Hospital, Cape Town, South Africa; Division of Radiation Oncology, Stellenbosch University and Tygerberg Hospital, Cape Town, South Africa.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Mngqibisa', 'Affiliation': 'Durban International Clinical Research Site, Enhancing Care Foundation, Durban, South Africa.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Nokta', 'Affiliation': 'Office of HIV and AIDS Malignancy, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Campbell', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Margaret Z', 'Initials': 'MZ', 'LastName': 'Borok', 'Affiliation': 'Department of Medicine, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)33222-2'] 59,31791665,"The renal hemodynamic effects of the SGLT2 inhibitor dapagliflozin are caused by post-glomerular vasodilatation rather than pre-glomerular vasoconstriction in metformin-treated patients with type 2 diabetes in the randomized, double-blind RED trial.","Sodium-glucose cotransporter 2 inhibitors (SGLT2i) improve hard renal outcomes in type 2 diabetes. This is possibly explained by the fact that SGLT2i normalize the measured glomerular filtration rate (mGFR) by increasing renal vascular resistance, as was shown in young people with type 1 diabetes and glomerular hyperfiltration. Therefore, we compared the renal hemodynamic effects of dapagliflozin with gliclazide in type 2 diabetes. The mGFR and effective renal plasma flow were assessed using inulin and para-aminohippurate clearances in the fasted state, during clamped euglycemia (5 mmol/L) and during clamped hyperglycemia (15 mmol/L). Filtration fraction and renal vascular resistance were calculated. Additionally, factors known to modulate renal hemodynamics were measured. In 44 people with type 2 diabetes on metformin monotherapy (Hemoglobin A1c 7.4%, mGFR 113 mL/min), dapagliflozin versus gliclazide reduced mGFR by 5, 10, and 12 mL/min in the consecutive phases while both agents similarly improved Hemoglobin A1c (-0.48% vs -0.65%). Dapagliflozin also reduced filtration fraction without increasing renal vascular resistance, and increased urinary adenosine and prostaglandin concentrations. Gliclazide did not consistently alter renal hemodynamic parameters. Thus, beyond glucose control, SGLT2i reduce mGFR and filtration fraction in type 2 diabetes. The fact that renal vascular resistance was not increased by dapagliflozin suggests that this is due to post-glomerular vasodilation rather than pre-glomerular vasoconstriction.",2020,"Dapagliflozin also reduced filtration fraction without increasing renal vascular resistance, and increased urinary adenosine and prostaglandin concentrations.","['44 people with type 2 diabetes on', 'type 2 diabetes', 'young people with type 1 diabetes and glomerular hyperfiltration', 'treated patients with type 2 diabetes']","['dapagliflozin versus gliclazide', 'SGLT2 inhibitor dapagliflozin', 'metformin', 'Gliclazide', 'Sodium-glucose cotransporter 2 inhibitors (SGLT2i', 'dapagliflozin', 'metformin monotherapy', 'dapagliflozin with gliclazide', 'Dapagliflozin']","['renal hemodynamic effects', 'urinary adenosine and prostaglandin concentrations', 'renal hemodynamic parameters', 'Hemoglobin A1c', 'renal hemodynamics', 'mGFR and effective renal plasma flow', 'renal vascular resistance', 'glomerular filtration rate (mGFR', 'Filtration fraction and renal vascular resistance']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0017631', 'cui_str': 'Gliclazide'}, {'cui': 'C3273807', 'cui_str': 'Gliflozins'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0001443', 'cui_str': 'Adenosine'}, {'cui': 'C0356622', 'cui_str': 'Prostaglandins, oxytocics'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0206088', 'cui_str': 'ERPF'}, {'cui': 'C0429119', 'cui_str': 'Vascular resistance (observable entity)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0016107', 'cui_str': 'Filtration - action'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}]",113.0,0.0276821,"Dapagliflozin also reduced filtration fraction without increasing renal vascular resistance, and increased urinary adenosine and prostaglandin concentrations.","[{'ForeName': 'Erik J M', 'Initials': 'EJM', 'LastName': 'van Bommel', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, location VUMC, Amsterdam, The Netherlands. Electronic address: e.vanbommel@amsterdamumc.nl.'}, {'ForeName': 'Marcel H A', 'Initials': 'MHA', 'LastName': 'Muskiet', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Michaël J B', 'Initials': 'MJB', 'LastName': 'van Baar', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Tonneijck', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Mark M', 'Initials': 'MM', 'LastName': 'Smits', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Emanuel', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bozovic', 'Affiliation': 'Department of Clinical Biochemistry, University Health Network, University of Toronto, Toronto, Ontario, Canada; Department of Laboratory Medicine and Pathobiology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'A H Jan', 'Initials': 'AHJ', 'LastName': 'Danser', 'Affiliation': 'Division of Pharmacology and Vascular Medicine, Department of Internal Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Geurts', 'Affiliation': 'Division of Nephrology and Transplantation, Department of Internal Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Ewout J', 'Initials': 'EJ', 'LastName': 'Hoorn', 'Affiliation': 'Division of Nephrology and Transplantation, Department of Internal Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Daan J', 'Initials': 'DJ', 'LastName': 'Touw', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Emil L', 'Initials': 'EL', 'LastName': 'Larsen', 'Affiliation': 'Department of Clinical Pharmacology, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Henrik E', 'Initials': 'HE', 'LastName': 'Poulsen', 'Affiliation': 'Department of Clinical Pharmacology, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mark H H', 'Initials': 'MHH', 'LastName': 'Kramer', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Nieuwdorp', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Jaap A', 'Initials': 'JA', 'LastName': 'Joles', 'Affiliation': 'Department of Nephrology and Hypertension, University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Daniël H', 'Initials': 'DH', 'LastName': 'van Raalte', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, location VUMC, Amsterdam, The Netherlands.'}]",Kidney international,['10.1016/j.kint.2019.09.013'] 60,32229520,Protocol for a randomised trial of an interprofessional team-delivered intervention to support surrogate decision-makers in ICUs.,"INTRODUCTION Although shortcomings in clinician-family communication and decision making for incapacitated, critically ill patients are common, there are few rigorously tested interventions to improve outcomes. In this manuscript, we present our methodology for the Pairing Re-engineered Intensive Care Unit Teams with Nurse-Driven Emotional support and Relationship Building (PARTNER 2) trial, and discuss design challenges and their resolution. METHODS AND ANALYSIS This is a pragmatic, stepped-wedge, cluster randomised controlled trial comparing the PARTNER 2 intervention to usual care among 690 incapacitated, critically ill patients and their surrogates in five ICUs in Pennsylvania. Eligible subjects will include critically ill patients at high risk of death and/or severe long-term functional impairment, their main surrogate decision-maker and their clinicians. The PARTNER intervention is delivered by the interprofessional ICU team and overseen by 4-6 nurses from each ICU. It involves: (1) advanced communication skills training for nurses to deliver support to surrogates throughout the ICU stay; (2) deploying a structured family support pathway; (3) enacting strategies to foster collaboration between ICU and palliative care services and (4) providing intensive implementation support to each ICU to incorporate the family support pathway into clinicians' workflow. The primary outcome is surrogates' ratings of the quality of communication during the ICU stay as assessed by telephone at 6-month follow-up. Prespecified secondary outcomes include surrogates' scores on the Hospital Anxiety and Depression Scale, the Impact of Event Scale, the modified Patient Perception of Patient Centredness scale, the Decision Regret Scale, nurses' scores on the Maslach Burnout Inventory, and length of stay during and costs of the index hospitalisation.We also discuss key methodological challenges, including determining the optimal level of randomisation, using existing staff to deploy the intervention and maximising long-term follow-up of participants. ETHICS AND DISSEMINATION We obtained ethics approval through the University of Pittsburgh, Human Research Protection Office. The findings will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER NCT02445937.",2020,"Prespecified secondary outcomes include surrogates' scores on the Hospital Anxiety and Depression Scale, the Impact of Event Scale, the modified Patient Perception of Patient Centredness scale, the Decision Regret Scale, nurses' scores on the Maslach Burnout Inventory, and length of stay during and costs of the index hospitalisation.","['Eligible subjects will include critically ill patients at high risk of death and/or severe long-term functional impairment, their main surrogate decision-maker and their clinicians', '690 incapacitated, critically ill patients and their surrogates in five ICUs in Pennsylvania']",[],"[""surrogates' scores on the Hospital Anxiety and Depression Scale, the Impact of Event Scale, the modified Patient Perception of Patient Centredness scale, the Decision Regret Scale, nurses' scores on the Maslach Burnout Inventory, and length of stay during and costs of the index hospitalisation"", ""surrogates' ratings of the quality of communication during the ICU stay""]","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0554244', 'cui_str': 'Maker (occupation)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0451226', 'cui_str': 'Impact of event scale (assessment scale)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0222045'}, {'cui': 'C0080101', 'cui_str': 'Regret'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state (disorder)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]",,0.0661771,"Prespecified secondary outcomes include surrogates' scores on the Hospital Anxiety and Depression Scale, the Impact of Event Scale, the modified Patient Perception of Patient Centredness scale, the Decision Regret Scale, nurses' scores on the Maslach Burnout Inventory, and length of stay during and costs of the index hospitalisation.","[{'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Lincoln', 'Affiliation': 'Department of General Internal Medicine, Section of Palliative Care and Medical Ethics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Shields', 'Affiliation': 'Department of Critical Care Medicine, The CRISMA Center, Program on Ethics and Decision Making, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Praewpannarai', 'Initials': 'P', 'LastName': 'Buddadhumaruk', 'Affiliation': 'Department of Critical Care Medicine, The CRISMA Center, Program on Ethics and Decision Making, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Chung-Chou H', 'Initials': 'CH', 'LastName': 'Chang', 'Affiliation': 'Department of Biostatistics, University of Pittsburgh Graduate School of Public Health, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Pike', 'Affiliation': 'Department of Neuroscience, Ely Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Hsiangyu', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Brown', 'Affiliation': 'Department of Critical Care Medicine, The CRISMA Center, Program on Ethics and Decision Making, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Kozar', 'Affiliation': 'Department of Critical Care Medicine, The CRISMA Center, Program on Ethics and Decision Making, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Pidro', 'Affiliation': 'Department of Critical Care Medicine, The CRISMA Center, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Kahn', 'Affiliation': 'Department of Critical Care Medicine, The CRISMA Center, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Darby', 'Affiliation': 'Department of Critical Care Medicine, The CRISMA Center, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Martin', 'Affiliation': 'Donald Wolff Center for Quality Improvement and Innovation, UPMC Health System, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Derek C', 'Initials': 'DC', 'LastName': 'Angus', 'Affiliation': 'Department of Critical Care Medicine, The CRISMA Center, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Arnold', 'Affiliation': 'Department of General Internal Medicine, Section of Palliative Care and Medical Ethics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Douglas B', 'Initials': 'DB', 'LastName': 'White', 'Affiliation': 'Department of Critical Care Medicine, The CRISMA Center, Program on Ethics and Decision Making, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA douglas.white@pitt.edu.'}]",BMJ open,['10.1136/bmjopen-2019-033521'] 61,31012044,Three-Dimensional Visualization Technology Used in Pancreatic Surgery: a Valuable Tool for Surgical Trainees.,"PURPOSE Three-dimensional (3D) visualization technology has been increasingly applied in patient-specific surgeries, but its value in residency training has not been determined. This study aimed to explore the value of 3D visualized pancreatic model in tumor evaluation and surgery planning for surgical trainees. METHODS Eighty-eight surgical residents were randomized into two groups (computed tomography (CT) group and 3D group). Both groups began with a training on evaluating the resectability of pancreatic tumor, which was based on the NCCN clinical practice guidelines and practiced on a sample case. Then, they respectively learned the sample case either on 3D reconstruction visualization tables or CT images. Finally, both groups completed a same test consisting of two pancreatic cases with CT images as well as questionnaires. RESULTS No differences were found in scores of the anatomy and diagnosis part, while mean scores for questions, associated with tumor staging and surgery planning, were consistently and significantly higher in the 3D group. In addition, participants in 3D group agreed that 3D technology was more beneficial in understanding and making pancreatic surgery planning. CONCLUSION The 3D visualization table may be a potential supplemental learning tool in building anatomy-image-surgery knowledge system and thus making surgery planning for surgical trainees.",2020,"No differences were found in scores of the anatomy and diagnosis part, while mean scores for questions, associated with tumor staging and surgery planning, were consistently and significantly higher in the 3D group.",['Eighty-eight surgical residents'],['computed tomography (CT'],"['scores of the anatomy and diagnosis part, while mean scores for questions, associated with tumor staging and surgery planning']","[{'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}]",88.0,0.0121908,"No differences were found in scores of the anatomy and diagnosis part, while mean scores for questions, associated with tumor staging and surgery planning, were consistently and significantly higher in the 3D group.","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Lin', 'Affiliation': 'Department of General Surgery, Peking Union Medical College Hospital (PUMCH), Chinese Academy of Medical Sciences & Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China.'}, {'ForeName': 'Junyi', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Eight-year Program of Clinical Medicine, PUMCH, CAMS & PUMC, Beijing, 100730, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Eight-year Program of Clinical Medicine, PUMCH, CAMS & PUMC, Beijing, 100730, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Education, PUMCH, CAMS & PUMC, Beijing, 100730, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Head and Neck Surgery, PUMCH, CAMS & PUMC, Beijing, 100730, China.'}, {'ForeName': 'Guole', 'Initials': 'G', 'LastName': 'Lin', 'Affiliation': 'Department of General Surgery, Peking Union Medical College Hospital (PUMCH), Chinese Academy of Medical Sciences & Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China.'}, {'ForeName': 'Hanzhong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Urology Surgery, PUMCH, CAMS & PUMC, Beijing, 100730, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': 'National Virtual Simulation Laboratory Education Center of Medical Sciences, PUMCH, CAMS & PUMC, Beijing, 100730, China.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Liao', 'Affiliation': 'Department of General Surgery, Peking Union Medical College Hospital (PUMCH), Chinese Academy of Medical Sciences & Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China. lqpumc@126.com.'}, {'ForeName': 'Yupei', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of General Surgery, Peking Union Medical College Hospital (PUMCH), Chinese Academy of Medical Sciences & Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China. zhao8028@263.net.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-019-04214-z'] 62,27158553,The Impact of Repeat HIV Testing on Risky Sexual Behavior: Evidence from a Randomized Controlled Trial in Malawi.,"A significant proportion of HIV-positive adults in sub-Saharan Africa are in serodiscordant relationships. Identification of such serodiscordant couples through couple HIV testing and counseling (HTC) is thought to promote safe sexual behavior and reduce the probability of within couple seroconversion. However, it is possible HTC benefits are not sustained over time and therefore repeated HTC may be more effective at preventing seroconversion than one time HTC. We tested this theory in Zomba, Malawi by randomly assigning 170 serodiscordant couples to receive repeated HTC and 167 serodiscordant couples to receive one time HTC upon study enrollment (control group). We used linear probability models and probit model with couple fixed effects to assess the impact of the intervention on risky sexual behavior. At one-year follow-up, we found that couples that received repeated HTC reported significantly more condom use. However, we found no difference in rate of seroconversion between groups, nor did we find differences in subjective expectations about seroconversion or false beliefs about HIV, two expected pathways of behavior change. We conclude that repeated HTC may promote safe sexual behavior, but this result should be interpreted with caution, as it is inconsistent with the result from biological and subjective outcomes.",2016,"However, we found no difference in rate of seroconversion between groups, nor did we find differences in subjective expectations about seroconversion or false beliefs about HIV, two expected pathways of behavior change.",['170 serodiscordant couples to receive repeated HTC and 167 serodiscordant couples to receive one time'],"['HTC', 'Repeat HIV Testing', 'couple HIV testing and counseling (HTC']","['rate of seroconversion', 'Risky Sexual Behavior', 'risky sexual behavior']","[{'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}]",170.0,0.110961,"However, we found no difference in rate of seroconversion between groups, nor did we find differences in subjective expectations about seroconversion or false beliefs about HIV, two expected pathways of behavior change.","[{'ForeName': 'Adeline', 'Initials': 'A', 'LastName': 'Delavande', 'Affiliation': 'Institute for Social and Economic Research, University of Essex, Colchester, UK.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Wagner', 'Affiliation': 'School of Public Health, University of California, Berkeley, 50 University Hall, Berkeley, CA, United States.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Sood', 'Affiliation': 'Schaeffer Center for Health Policy and Economics, University of Southern California, Los Angeles, United States.'}]",Journal of AIDS & clinical research,[] 63,32282034,"Effects of Telephone and Short Message Service Support on Infant Feeding Practices, ""Tummy Time,"" and Screen Time at 6 and 12 Months of Child Age: A 3-Group Randomized Clinical Trial.","Importance There is limited information as to whether telephone or short message service (SMS) support is effective in improving infant feeding practices and tummy time and reducing screen time. Objective To determine the effectiveness of either nurse-led telephone or SMS support in improving infant feeding practices and tummy time and reducing screen time. Design, Setting, and Participants This study was part of a 2-year, 3-group parallel, randomized clinical trial conducted from February 23, 2017, to November 30, 2018, among 1155 women in the third trimester of pregnancy in New South Wales, Australia. It reports the main outcomes at 6 and 12 months of child age. All analyses were conducted on an intention-to-treat principle. Interventions The intervention consisted of staged information booklets mailed to the intervention groups, each followed by either a nurse-led telephone support session or SMS intervention, antenatally and at 1, 3, 5, 7, and 10 months after birth. Main Outcomes and Measures The primary outcomes were infant feeding practices at both 6 and 12 months and tummy time at 6 months. The secondary outcome was screen time at 12 months. Results Of 1155 mothers, 947 (82%; mean [SD] age, 32.5 [5.0] years) completed follow-up surveys at 6 months; 920 mothers (80%) completed follow-up surveys at 12 months. Compared with the control group, telephone support led to higher odds of appropriate timing of introducing solid foods (adjusted odds ratio [AOR], 1.68 [95% CI, 1.22-2.32]), cup use (AOR, 1.54 [95% CI, 1.12-2.13]), and early-start tummy time (AOR, 1.63 [95% CI, 1.18-2.25]) at 6 months and higher odds of having no screen time (AOR, 1.80 [95% CI, 1.28-2.53]) and no bottle at bedtime (AOR, 1.73 [95% CI, 1.23-2.42]) at 12 months. Use of SMS also led to higher odds than the control group of having no screen time (AOR, 1.28 [95% CI, 1.08-1.52]) and having no bottle at bedtime (AOR, 1.29 [95% CI, 1.10-1.51]) at 12 months. No significant differences were found in breastfeeding rates between the telephone support, SMS support, and control groups. Conclusions and Relevance Both the nurse-led telephone support and SMS interventions were effective in reducing screen time and bottle use at bedtime. Telephone support was also effective in promoting the appropriate timing of the introduction of solid foods, early-start tummy time, and cup use. Trial Registration http://anzctr.org.au Identifier: ACTRN12616001470482.",2020,"Compared with the control group, telephone support led to higher odds of appropriate timing of introducing solid foods (adjusted odds ratio [AOR], 1.68 [95% CI, 1.22-2.32]), cup use (AOR, 1.54 [95% CI, 1.12-2.13]), and early-start tummy time (AOR, 1.63","['at 6 and 12 Months of Child Age', '1155 mothers, 947 (82%; mean [SD] age, 32.5 [5.0] years) completed follow-up surveys at 6 months; 920 mothers (80%) completed follow-up surveys at 12 months', 'February 23, 2017, to November 30, 2018, among 1155 women in the third trimester of pregnancy in New South Wales, Australia']","['Telephone and Short Message Service Support', 'nurse-led telephone or SMS support', 'http://anzctr.org.au Identifier', 'SMS', 'nurse-led telephone support session or SMS intervention']","['Infant Feeding Practices, ""Tummy Time,"" and Screen Time', 'breastfeeding rates', 'infant feeding practices at both 6 and 12 months and tummy time', 'screen time and bottle use', 'screen time at 12 months']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517710', 'cui_str': '32.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0179376', 'cui_str': 'Bottle'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.0996758,"Compared with the control group, telephone support led to higher odds of appropriate timing of introducing solid foods (adjusted odds ratio [AOR], 1.68 [95% CI, 1.22-2.32]), cup use (AOR, 1.54 [95% CI, 1.12-2.13]), and early-start tummy time (AOR, 1.63","[{'ForeName': 'Li Ming', 'Initials': 'LM', 'LastName': 'Wen', 'Affiliation': 'Health Promotion, Population Health Research and Evaluation Hub, Sydney Local Health District, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Rissel', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Huilan', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Health Promotion, Population Health Research and Evaluation Hub, Sydney Local Health District, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Taki', 'Affiliation': 'Health Promotion, Population Health Research and Evaluation Hub, Sydney Local Health District, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Buchanan', 'Affiliation': 'Health Promotion, Population Health Research and Evaluation Hub, Sydney Local Health District, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Bedford', 'Affiliation': 'Health Promotion, Population Health Research and Evaluation Hub, Sydney Local Health District, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Philayrath', 'Initials': 'P', 'LastName': 'Phongsavan', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Louise A', 'Initials': 'LA', 'LastName': 'Baur', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2020.0215'] 64,32296094,Clinical Study on the Effectiveness of Three Products in the Treatment of Herpes Simplex Labialis.,"Herpes simplex labialis (HSL) is a viral disease that affects the perioral region. No guidelines recommending an effective treatment exist. The treatment of HSL with three different products was examined. Herpatch Serum, a film-forming patch, was compared to Compeed Patches, a set of semiocclusive hydrocolloid patches, and Zovirax Cream (ingredient: 5% acyclovir). In this prospective, randomized, examiner-blind study, 180 patients with recurrent HSL were split into three groups (Compeed: n = 60, Herpatch: n = 60, Zovirax: n = 60) and examined within 24 hours of HSL outbreak (DRKS Registration No.: DRKS00007786). The primary endpoint was healing time. The secondary endpoints were the reaction rate and quality of therapy evaluated by the Clinician's Global Assessment of Therapy (CGAT) and the Subject's Global Assessment of Therapy (SGAT) (0 = no response; 10 = excellent response), respectively. There was no significant difference among the healing times for the different products. The mean (95% confidence interval) was 9.67 days (9.11-10.22) for Compeed, 9.30 days (8.75-9.85) for Herpatch, and 9.80 days (9.30-10.30) for Zovirax. The reaction rate and quality of therapy (CGAT and SGAT) of Herpatch were significantly higher than those of Compeed and Zovirax. Within the study limitations, Herpatch proved to be an effective, non-antiviral alternative in the treatment of HSL.",2020,"Within the study limitations, Herpatch proved to be an effective, non-antiviral alternative in the treatment of HSL.","['Herpes simplex labialis (HSL', '180 patients with recurrent HSL', 'Herpes Simplex Labialis']","['Herpatch: n\u2009=\u200960, Zovirax: n\u2009=\u200960) and examined within 24\u2009hours of HSL outbreak (DRKS Registration No', 'Zovirax Cream (ingredient: 5% acyclovir']","['reaction rate and quality of therapy (CGAT and SGAT) of Herpatch', ""reaction rate and quality of therapy evaluated by the Clinician's Global Assessment of Therapy (CGAT) and the Subject's Global Assessment of Therapy (SGAT"", 'healing time', 'healing times']","[{'cui': 'C0228492', 'cui_str': 'Structure of posterior semilunar lobule'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]","[{'cui': 'C0592290', 'cui_str': 'Zovirax'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0228492', 'cui_str': 'Structure of posterior semilunar lobule'}, {'cui': 'C0012652', 'cui_str': 'Disease outbreak'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0001367', 'cui_str': 'Acyclovir'}]","[{'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",180.0,0.0268437,"Within the study limitations, Herpatch proved to be an effective, non-antiviral alternative in the treatment of HSL.","[{'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Boes', 'Affiliation': 'Department of Operative and Preventive Dentistry, Faculty of Health, Witten/Herdecke University, Witten, Germany. Hanna.Boes@uni-wh.de.'}, {'ForeName': 'Vlasios', 'Initials': 'V', 'LastName': 'Goulioumis', 'Affiliation': 'Department of Operative and Preventive Dentistry, Faculty of Health, Witten/Herdecke University, Witten, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wechsler', 'Affiliation': 'Department of Operative and Preventive Dentistry, Faculty of Health, Witten/Herdecke University, Witten, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Zimmer', 'Affiliation': 'Department of Operative and Preventive Dentistry, Faculty of Health, Witten/Herdecke University, Witten, Germany.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Bizhang', 'Affiliation': 'Department of Operative and Preventive Dentistry, Faculty of Health, Witten/Herdecke University, Witten, Germany.'}]",Scientific reports,['10.1038/s41598-020-63530-6'] 65,31920733,A Proof-of-Mechanism Study to Test Effects of the NMDA Receptor Antagonist Lanicemine on Behavioral Sensitization in Individuals With Symptoms of PTSD.,"Background: Individuals with post-traumatic stress disorder (PTSD) have a heightened sensitivity to subsequent stressors, addictive drugs, and symptom recurrence, a form of behavioral sensitization. N-methyl-D-aspartate receptors (NMDARs) are involved in the establishment and activation of sensitized behavior. Objective: We describe a protocol of a randomized placebo-controlled Phase 1b proof-of-mechanism trial to examine target engagement, safety, tolerability, and possible efficacy of the NMDAR antagonist lanicemine in individuals with symptoms of PTSD (Clinician Administered PTSD Scale [CAPS-5] score ≥ 25) and evidence of behavioral sensitization measured as enhanced anxiety-potentiated startle (APS; T-score ≥ 2.8). Methods: Subjects (n = 24; age range 21-65) receive three 60-min intravenous infusions of placebo or 100 mg lanicemine over 5 non-consecutive days. Primary endpoint is change in APS from pre-treatment baseline to after the third infusion. NMDAR engagement is probed with resting state EEG gamma band power, 40 Hz auditory steady state response, the mismatch negativity amplitude, and P50 sensory gating. Change in CAPS-5 scores is an exploratory clinical endpoint. Bayesian statistical methods will evaluate endpoints to determine suitability of this agent for further study. Conclusion: In contrast to traditional early-phase trials that use symptom severity to track treatment efficacy, this study tracks engagement of the study drug on expression of behavioral sensitization, a functional mechanism likely to cut across disorders. This experimental therapeutics design is consistent with recent NIMH-industry collaborative studies, and could serve as a template for testing novel pharmacological agents in psychiatry. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT03166501.",2019,"NMDAR engagement is probed with resting state EEG gamma band power, 40 Hz auditory steady state response, the mismatch negativity amplitude, and P50 sensory gating.","['Individuals with post-traumatic stress disorder (PTSD', 'individuals with symptoms of PTSD (Clinician Administered PTSD Scale [CAPS-5] score ≥ 25', 'Methods: Subjects (n = 24; age range 21-65', 'Individuals With Symptoms of PTSD']","['placebo or 100 mg lanicemine', 'N-methyl-D-aspartate receptors (NMDARs', 'NMDA Receptor Antagonist Lanicemine', 'placebo', 'NMDAR antagonist lanicemine']","['resting state EEG gamma band power, 40 Hz auditory steady state response, the mismatch negativity amplitude, and P50 sensory gating', 'change in APS', 'CAPS-5 scores']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0222045'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2697880'}, {'cui': 'C0080093', 'cui_str': 'N-Methyl-D-Aspartate Receptors'}, {'cui': 'C0598695', 'cui_str': 'NMDA receptor antagonist'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C1552644', 'cui_str': 'Greek letter gamma'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0219874', 'cui_str': 'tyrosine protein kinase p50csk'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.147479,"NMDAR engagement is probed with resting state EEG gamma band power, 40 Hz auditory steady state response, the mismatch negativity amplitude, and P50 sensory gating.","[{'ForeName': 'Marijn', 'Initials': 'M', 'LastName': 'Lijffijt', 'Affiliation': 'Research Service Line, Michael E. DeBakey VA Medical Center, Houston, TX, United States.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Green', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, UTHealth McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX, United States.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Balderston', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, United States.'}, {'ForeName': 'Tabish', 'Initials': 'T', 'LastName': 'Iqbal', 'Affiliation': 'Research Service Line, Michael E. DeBakey VA Medical Center, Houston, TX, United States.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Atkinson', 'Affiliation': 'Department of Anesthesiology, Michael E. DeBakey VA Medical Center, Houston, TX, United States.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Vo-Le', 'Affiliation': 'Research Service Line, Michael E. DeBakey VA Medical Center, Houston, TX, United States.'}, {'ForeName': 'Bylinda', 'Initials': 'B', 'LastName': 'Vo-Le', 'Affiliation': 'Research Service Line, Michael E. DeBakey VA Medical Center, Houston, TX, United States.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': ""O'Brien"", 'Affiliation': 'Research Service Line, Michael E. DeBakey VA Medical Center, Houston, TX, United States.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Grillon', 'Affiliation': 'Department of Pediatrics - Center for Evidence Based Medicine, UTHealth McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX, United States.'}, {'ForeName': 'Alan C', 'Initials': 'AC', 'LastName': 'Swann', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Sanjay J', 'Initials': 'SJ', 'LastName': 'Mathew', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, United States.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2019.00846'] 66,30653422,"Autologous Transplantation, Consolidation, and Maintenance Therapy in Multiple Myeloma: Results of the BMT CTN 0702 Trial.","PURPOSE Single-cycle melphalan 200 mg/m 2 and autologous hematopoietic cell transplantation (AHCT) followed by lenalidomide (len) maintenance have improved progression-free survival (PFS) and overall survival (OS) for transplantation-eligible patients with multiple myeloma (MM). We designed a prospective, randomized, phase III study to test additional interventions to improve PFS by comparing AHCT, tandem AHCT (AHCT/AHCT), and AHCT and four subsequent cycles of len, bortezomib, and dexamethasone (RVD; AHCT + RVD), all followed by len until disease progression. PATIENTS AND METHODS Patients with symptomatic MM within 12 months from starting therapy and without progression who were age 70 years or younger were randomly assigned to AHCT/AHCT + len (n = 247), AHCT + RVD + len (n = 254), or AHCT + len (n = 257). The primary end point was 38-month PFS. RESULTS The study population had a median age of 56 years (range, 20 to 70 years); 24% of patients had high-risk MM, 73% had a triple-drug regimen as initial therapy, and 18% were in complete response at enrollment. The 38-month PFS rate was 58.5% (95% CI, 51.7% to 64.6%) for AHCT/AHCT + len, 57.8% (95% CI, 51.4% to 63.7%) for AHCT + RVD + len, and 53.9% (95% CI, 47.4% to 60%) for AHCT + len. For AHCT/AHCT + len, AHCT + RVD + len, and AHCT + len, the OS rates were 81.8% (95% CI, 76.2% to 86.2%), 85.4% (95% CI, 80.4% to 89.3%), and 83.7% (95% CI, 78.4% to 87.8%), respectively, and the complete response rates at 1 year were 50.5% (n = 192), 58.4% (n = 209), and 47.1% (n = 208), respectively. Toxicity profiles and development of second primary malignancies were similar across treatment arms. CONCLUSION Second AHCT or RVD consolidation as post-AHCT interventions for the up-front treatment of transplantation-eligible patients with MM did not improve PFS or OS. Single AHCT and len should remain as the standard approach for this population.",2019,"Toxicity profiles and development of second primary malignancies were similar across treatment arms. ","['Multiple Myeloma', 'transplantation-eligible patients with multiple myeloma (MM', 'Patients with symptomatic MM within 12 months from starting therapy and without progression who were age 70 years or younger', 'The study population had a median age of 56 years (range, 20 to 70 years); 24% of patients had high-risk MM, 73% had a triple-drug regimen as initial therapy, and 18% were in complete response at enrollment']","['melphalan 200 mg/m 2 and autologous hematopoietic cell transplantation (AHCT) followed by lenalidomide (len) maintenance', 'AHCT, tandem AHCT (AHCT/AHCT), and AHCT and four subsequent cycles of len, bortezomib, and dexamethasone (RVD; AHCT + RVD', 'AHCT + RVD + len', 'Autologous Transplantation, Consolidation, and Maintenance Therapy', 'AHCT + len', 'AHCT/AHCT + len']","['38-month PFS', 'complete response rates', '38-month PFS rate', 'Toxicity profiles and development of second primary malignancies', 'progression-free survival (PFS) and overall survival (OS', 'PFS or OS', 'OS rates']","[{'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0751623', 'cui_str': 'Second Cancer'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",257.0,0.105093,"Toxicity profiles and development of second primary malignancies were similar across treatment arms. ","[{'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Stadtmauer', 'Affiliation': '1 University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Marcelo C', 'Initials': 'MC', 'LastName': 'Pasquini', 'Affiliation': '2 Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Blackwell', 'Affiliation': '3 The Emmes Corporation, Rockville, MD.'}, {'ForeName': 'Parameswaran', 'Initials': 'P', 'LastName': 'Hari', 'Affiliation': '2 Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Asad', 'Initials': 'A', 'LastName': 'Bashey', 'Affiliation': '4 BMT Group of Georgia, Atlanta, GA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Devine', 'Affiliation': '5 The Ohio State University, Columbus, OH.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Efebera', 'Affiliation': '5 The Ohio State University, Columbus, OH.'}, {'ForeName': 'Siddharta', 'Initials': 'S', 'LastName': 'Ganguly', 'Affiliation': '6 University of Kansas Hospital, Kansas City, KS.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Gasparetto', 'Affiliation': '7 Duke University, Durham, NC.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Geller', 'Affiliation': '8 National Heart, Lung, and Blood Institute, Rockville, MD.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'Horowitz', 'Affiliation': '2 Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Koreth', 'Affiliation': '9 Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Knust', 'Affiliation': '3 The Emmes Corporation, Rockville, MD.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Landau', 'Affiliation': '10 Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Brunstein', 'Affiliation': '11 University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'McCarthy', 'Affiliation': '12 Roswell Park Cancer Institute, Buffalo, NY.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Nelson', 'Affiliation': '3 The Emmes Corporation, Rockville, MD.'}, {'ForeName': 'Muzaffar H', 'Initials': 'MH', 'LastName': 'Qazilbash', 'Affiliation': '13 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Shah', 'Affiliation': '14 University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Vesole', 'Affiliation': '15 Hackensack University, Hackensack, NJ.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Vij', 'Affiliation': '16 Washington University, St Louis, MO.'}, {'ForeName': 'Dan T', 'Initials': 'DT', 'LastName': 'Vogl', 'Affiliation': '1 University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Giralt', 'Affiliation': '10 Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Somlo', 'Affiliation': '17 City of Hope, Los Angeles, CA.'}, {'ForeName': 'Amrita', 'Initials': 'A', 'LastName': 'Krishnan', 'Affiliation': '17 City of Hope, Los Angeles, CA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.00685'] 67,32203691,"Efficacy of levetiracetam, fosphenytoin, and valproate for established status epilepticus by age group (ESETT): a double-blind, responsive-adaptive, randomised controlled trial.","BACKGROUND Benzodiazepine-refractory, or established, status epilepticus is thought to be of similar pathophysiology in children and adults, but differences in underlying aetiology and pharmacodynamics might differentially affect response to therapy. In the Established Status Epilepticus Treatment Trial (ESETT) we compared the efficacy and safety of levetiracetam, fosphenytoin, and valproate in established status epilepticus, and here we describe our results after extending enrolment in children to compare outcomes in three age groups. METHODS In this multicentre, double-blind, response-adaptive, randomised controlled trial, we recruited patients from 58 hospital emergency departments across the USA. Patients were eligible for inclusion if they were aged 2 years or older, had been treated for a generalised convulsive seizure of longer than 5 min duration with adequate doses of benzodiazepines, and continued to have persistent or recurrent convulsions in the emergency department for at least 5 min and no more than 30 min after the last dose of benzodiazepine. Patients were randomly assigned in a response-adaptive manner, using Bayesian methods and stratified by age group (<18 years, 18-65 years, and >65 years), to levetiracetam, fosphenytoin, or valproate. All patients, investigators, study staff, and pharmacists were masked to treatment allocation. The primary outcome was absence of clinically apparent seizures with improved consciousness and without additional antiseizure medication at 1 h from start of drug infusion. The primary safety outcome was life-threatening hypotension or cardiac arrhythmia. The efficacy and safety outcomes were analysed by intention to treat. This study is registered in ClinicalTrials.gov, NCT01960075. FINDINGS Between Nov 3, 2015, and Dec 29, 2018, we enrolled 478 patients and 462 unique patients were included: 225 children (aged <18 years), 186 adults (18-65 years), and 51 older adults (>65 years). 175 (38%) patients were randomly assigned to levetiracetam, 142 (31%) to fosphenyltoin, and 145 (31%) were to valproate. Baseline characteristics were balanced across treatments within age groups. The primary efficacy outcome was met in those treated with levetiracetam for 52% (95% credible interval 41-62) of children, 44% (33-55) of adults, and 37% (19-59) of older adults; with fosphenytoin in 49% (38-61) of children, 46% (34-59) of adults, and 35% (17-59) of older adults; and with valproate in 52% (41-63) of children, 46% (34-58) of adults, and 47% (25-70) of older adults. No differences were detected in efficacy or primary safety outcome by drug within each age group. With the exception of endotracheal intubation in children, secondary safety outcomes did not significantly differ by drug within each age group. INTERPRETATION Children, adults, and older adults with established status epilepticus respond similarly to levetiracetam, fosphenytoin, and valproate, with treatment success in approximately half of patients. Any of the three drugs can be considered as a potential first-choice, second-line drug for benzodiazepine-refractory status epilepticus. FUNDING National Institute of Neurological Disorders and Stroke, National Institutes of Health.",2020,The primary outcome was absence of clinically apparent seizures with improved consciousness and without additional antiseizure medication at 1 h from start of drug infusion.,"['for 52% (95% credible interval 41-62) of children, 44% (33-55) of adults, and 37% (19-59) of older adults; with fosphenytoin in 49% (38-61) of children, 46% (34-59) of adults, and 35% (17-59) of older adults; and with valproate in 52% (41-63) of children, 46% (34-58) of adults, and 47% (25-70) of older adults', 'recruited patients from 58 hospital emergency departments across the USA', 'Children, adults, and older adults with established status epilepticus respond similarly to', 'Between Nov 3, 2015, and Dec 29, 2018, we enrolled 478 patients and 462 unique patients were included: 225 children (aged <18 years), 186 adults (18-65 years), and 51 older adults (>65 years', 'Patients were eligible for inclusion if they were aged 2 years or older, had been treated for a generalised convulsive seizure of longer than 5 min duration with adequate doses of benzodiazepines, and continued to have persistent or recurrent convulsions in the emergency department for at least 5 min and no more than 30 min after the last dose of']","['levetiracetam', 'levetiracetam, fosphenytoin, or valproate', 'levetiracetam, fosphenytoin, and valproate', 'benzodiazepine', 'valproate']","['efficacy and safety', 'life-threatening hypotension or cardiac arrhythmia', 'absence of clinically apparent seizures with improved consciousness and without additional antiseizure medication', 'efficacy and safety outcomes']","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0244656', 'cui_str': 'fosphenytoin'}, {'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0038220', 'cui_str': 'Status Epilepticus, Generalized'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0751494', 'cui_str': 'Convulsive Seizures'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1869075', 'cui_str': 'Convulsions (SMQ)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0244656', 'cui_str': 'fosphenytoin'}, {'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C1869051', 'cui_str': 'Cardiac arrhythmias (SMQ)'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}]",478.0,0.634583,The primary outcome was absence of clinically apparent seizures with improved consciousness and without additional antiseizure medication at 1 h from start of drug infusion.,"[{'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Chamberlain', 'Affiliation': ""Division of Emergency Medicine Children's National Hospital, Washington, DC, USA.""}, {'ForeName': 'Jaideep', 'Initials': 'J', 'LastName': 'Kapur', 'Affiliation': 'Department of Neurology, University of Virginia Health Sciences Center, Charlottesville, VA, USA.'}, {'ForeName': 'Shlomo', 'Initials': 'S', 'LastName': 'Shinnar', 'Affiliation': 'Neurology, Pediatrics and Epidemiology and Population Health Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Elm', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Maija', 'Initials': 'M', 'LastName': 'Holsti', 'Affiliation': 'Division of Pediatric Emergency Medicine, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Babcock', 'Affiliation': ""Division of Pediatric Emergency Medicine, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, OH, USA.""}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Rogers', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA; Department of Pediatrics, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Barsan', 'Affiliation': 'Department of Emergency Medicine, Neuro Emergencies Research, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Cloyd', 'Affiliation': 'Center for Orphan Drug Research, College of Pharmacy, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lowenstein', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Bleck', 'Affiliation': 'Division of Stroke and Neurocritical Care, Northwestern University Feinberg School of Medicine, Chicago, IL USA.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Conwit', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health Neuroscience Center, Bethesda, MD, USA.'}, {'ForeName': 'Caitlyn', 'Initials': 'C', 'LastName': 'Meinzer', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Cock', 'Affiliation': ""Institute of Molecular and Clinical Sciences, St George's University of London, London, UK.""}, {'ForeName': 'Nathan B', 'Initials': 'NB', 'LastName': 'Fountain', 'Affiliation': 'Department of Neurology, University of Virginia Health Sciences Center, Charlottesville, VA, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Underwood', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Jason T', 'Initials': 'JT', 'LastName': 'Connor', 'Affiliation': 'ConfluenceStat LLC and University of Central Florida College of Medicine, Cooper City, FL, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Silbergleit', 'Affiliation': 'Department of Emergency Medicine, Neuro Emergencies Research, University of Michigan, Ann Arbor, MI, USA. Electronic address: robert.silbergleit@umich.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30611-5'] 68,32323192,Associations between model-predicted rivaroxaban exposure and patient characteristics and efficacy and safety outcomes in patients with non-valvular atrial fibrillation.,"Rivaroxaban exposure and patient characteristics may affect the rivaroxaban benefit-risk balance. This study aimed to quantify associations between model-predicted rivaroxaban exposure and patient characteristics and efficacy and safety outcomes in patients with non-valvular atrial fibrillation (NVAF), using data from the phase 3 ROCKET AF trial (NCT00403767). In ROCKET AF, 14,264 patients with NVAF were randomized to rivaroxaban (20 mg once daily [OD], or 15 mg OD if creatinine clearance was 30-49 mL/min) or dose-adjusted warfarin (median follow-up: 707 days); rivaroxaban plasma concentration was measured in a subset of 161 patients. In this post hoc exposure-response analysis, a multivariate Cox model was used to correlate individual predicted rivaroxaban exposures and patient characteristics with time-to-event efficacy and safety outcomes in 7061 and 7111 patients, respectively. There was no significant association between model-predicted rivaroxaban trough plasma concentration (C trough ) and efficacy outcomes. Creatinine clearance and history of stroke were significantly associated with efficacy outcomes. C trough was significantly associated with the composite of major or non-major clinically relevant (NMCR) bleeding (hazard ratio [95th percentile vs. median]: 1.26 [95% confidence interval 1.13-1.40]) but not with major bleeding alone. The exposure-response relationship for major or NMCR bleeding was shallow with no clear threshold for an acceleration in risk. History of gastrointestinal bleeding had a greater influence on safety outcomes than C trough . These results support fixed rivaroxaban 15 mg and 20 mg OD dosages in NVAF. Therapeutic drug monitoring is unlikely to offer clinical benefits in this indication beyond evaluation of patient characteristics.",2020,There was no significant association between model-predicted rivaroxaban trough plasma concentration (C trough ) and efficacy outcomes.,"['14,264 patients with NVAF', 'patients with non-valvular atrial fibrillation (NVAF', 'patients with non-valvular atrial fibrillation']","['rivaroxaban', 'Rivaroxaban']","['safety outcomes', 'rivaroxaban trough plasma concentration (C trough ) and efficacy outcomes', 'composite of major or non-major clinically relevant (NMCR) bleeding', 'Creatinine clearance and history of stroke', 'rivaroxaban plasma concentration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",14264.0,0.0632288,There was no significant association between model-predicted rivaroxaban trough plasma concentration (C trough ) and efficacy outcomes.,"[{'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA. LZhang11@ITS.JNJ.com.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Keith A A', 'Initials': 'KAA', 'LastName': 'Fox', 'Affiliation': 'Centre for Cardiovascular Science, The University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Willmann', 'Affiliation': 'Clinical Pharmacometrics, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Partha', 'Initials': 'P', 'LastName': 'Nandy', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Bayer U.S., LLC, Research & Development, Pharmaceuticals, Whippany, NJ, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Hermanowski-Vosatka', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Jeffrey I', 'Initials': 'JI', 'LastName': 'Weitz', 'Affiliation': 'Thrombosis & Atherosclerosis Research Institute, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Solms', 'Affiliation': 'Clinical Pharmacometrics, Bayer AG, Berlin, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': 'Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, FL, USA.'}, {'ForeName': 'Manesh', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Peters', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}]",Journal of thrombosis and thrombolysis,['10.1007/s11239-020-02077-9'] 69,32268795,Sex Differences in Quality of Life and Clinical Outcomes in Patients With Advanced Heart Failure: Insights From the PAL-HF Trial.,"BACKGROUND Palliative care improves quality of life in patients with heart failure. Whether men and women with heart failure derive similar benefit from palliative care interventions remains unknown. METHODS In a secondary analysis of the PAL-HF trial (Palliative Care in Heart Failure), we analyzed differences in quality of life among men and women with heart failure and assessed for differential effects of the palliative care intervention by sex. Differences in clinical characteristics and quality-of-life metrics were compared between men and women at serial time points. The primary outcome was change in Kansas City Cardiomyopathy Questionnaire score between baseline and 24 weeks. RESULTS Among the 71 women and 79 men, there was a significant difference in baseline Kansas City Cardiomyopathy Questionnaire (24.5 versus 36.2, respectively; P =0.04) but not Functional Assessment of Chronic Illness Therapy-Palliative Care scale (115.7 versus 120.3; P =0.27) scores. Among those who received the palliative care intervention (33 women and 42 men), women's quality-of-life score remained lower than that of men after enrollment. Treated men's scores were significantly higher than those untreated (6-month Kansas City Cardiomyopathy Questionnaire, 68.0 [interquartile range, 52.6-85.7] versus 41.1[interquartile range, 32.0-78.3]; P =0.047), whereas the difference between treated and untreated women was not significantly different ( P =0.39). Rates of death and rehospitalization, as well as the composite end point, were similar between treated and untreated women and men. CONCLUSIONS In the PAL-HF trial, women with heart failure experienced a greater symptom burden and poorer quality of life as compared with men. The change in treated men's Kansas City Cardiomyopathy Questionnaire score between baseline and 24 weeks was significantly higher than those untreated; this trend was not observed in women. Thus, there may be a sex disparity in response to palliative care intervention, suggesting that sex-specific approaches to palliative care may be needed to improve outcomes. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT0158960.",2020,"Rates of death and rehospitalization, as well as the composite end point, were similar between treated and untreated women and men. ","['patients with heart failure', 'Patients With Advanced Heart Failure', '71 women and 79 men', 'men and women with heart failure']",['palliative care intervention'],"['Kansas City Cardiomyopathy Questionnaire score', 'Quality of Life and Clinical Outcomes', 'baseline Kansas City Cardiomyopathy Questionnaire', 'Rates of death and rehospitalization', 'quality of life', 'change in Kansas City Cardiomyopathy Questionnaire score', ""women's quality-of-life score"", 'symptom burden and poorer quality of life', 'Functional Assessment of Chronic Illness Therapy-Palliative Care scale', 'clinical characteristics and quality-of-life metrics']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0022497', 'cui_str': 'Kansas'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0699680', 'cui_str': 'Metric'}]",71.0,0.195253,"Rates of death and rehospitalization, as well as the composite end point, were similar between treated and untreated women and men. ","[{'ForeName': 'Lauren K', 'Initials': 'LK', 'LastName': 'Truby', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': ""O'Connor"", 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, VA (C.O.).'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Fiuzat', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Stebbins', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Coles', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Chetan B', 'Initials': 'CB', 'LastName': 'Patel', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Bradi', 'Initials': 'B', 'LastName': 'Granger', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Pagidipati', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Richa', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rymer', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Lowenstern', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tulsky', 'Affiliation': ""Division of Palliative Medicine, Department of Medicine, Dana Farber Cancer Institute, Brigham and Women's Hospital, Boston, MA (J.T.).""}, {'ForeName': 'Joseph G', 'Initials': 'JG', 'LastName': 'Rogers', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.119.006134'] 70,32268807,Clinical and Economic Implications of Inconclusive Noninvasive Test Results in Stable Patients With Suspected Coronary Artery Disease: Insights From the PROMISE Trial.,"BACKGROUND Inconclusive noninvasive tests complicate the care of patients with suspected coronary artery disease, but their prevalence and impact on management, outcomes, and costs are not well described. METHODS PROMISE (Prospective Multicenter Imaging Study for Evaluation of Chest Pain) patients were randomized to stress testing (n=4533) or computed tomographic angiography (CTA; n=4677). We assessed relationships between inconclusive results, subsequent testing, a composite outcome (death, myocardial infarction, or hospitalization for unstable angina), and healthcare expenditures. RESULTS Overall, 8.0% of tests were inconclusive (9.7% stress, 6.4% CTA). Compared with negative tests, inconclusive tests were more often referred to a second noninvasive test (stress: 14.6% versus 8.5%, odds ratio [OR], 1.91; CTA: 36.5% versus 8.4%, OR, 5.95; P <0.001) and catheterization (stress: 5.5% versus 2.4%, OR, 2.36; CTA: 23.4% versus 4.1%, OR, 6.49; P <0.001), and composite outcomes were higher for both inconclusive tests (stress: 3.7% versus 2.0%, hazard ratio, 1.81, P =0.034; CTA: 5.0% versus 2.2%, hazard ratio, 1.85; P =0.044) and positive tests (stress: 8.3% versus 2.0%, hazard ratio, 3.50; CTA: 9.2% versus 2.2%, hazard ratio, 3.66; P <0.001). Twenty-four-month costs were higher for inconclusive tests than negative tests by $2905 (stress) and $4030 (CTA). CONCLUSIONS Among patients with stable chest pain undergoing a noninvasive test, inconclusive results occurred in 6% of CTA and 10% of stress tests. Compared with those with conclusive negative tests, individuals with inconclusive results more often underwent subsequent testing, had increased medical costs, and experienced worse outcomes. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01174550.",2020,"Compared with those with conclusive negative tests, individuals with inconclusive results more often underwent subsequent testing, had increased medical costs, and experienced worse outcomes.","['Evaluation of Chest Pain', 'patients with stable chest pain undergoing a noninvasive test', 'patients with suspected coronary artery disease', 'Stable Patients With Suspected Coronary Artery Disease']",['stress testing (n=4533) or computed tomographic angiography (CTA'],"['composite outcomes', 'composite outcome (death, myocardial infarction, or hospitalization for unstable angina), and healthcare expenditures', 'medical costs']","[{'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.0805463,"Compared with those with conclusive negative tests, individuals with inconclusive results more often underwent subsequent testing, had increased medical costs, and experienced worse outcomes.","[{'ForeName': 'Akash', 'Initials': 'A', 'LastName': 'Goyal', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (A.G., N.P., C.L.H., B.A., D.B.M., P.S.D.).'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Pagidipati', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (A.G., N.P., C.L.H., B.A., D.B.M., P.S.D.).'}, {'ForeName': 'C Larry', 'Initials': 'CL', 'LastName': 'Hill', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (A.G., N.P., C.L.H., B.A., D.B.M., P.S.D.).'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Alhanti', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (A.G., N.P., C.L.H., B.A., D.B.M., P.S.D.).'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Udelson', 'Affiliation': 'Division of Cardiology, Tufts Medical Center, Boston, MA (J.E.U.).'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Picard', 'Affiliation': 'Department of Cardiology (M.H.P.), Massachusetts General Hospital, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Pellikka', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (P.A.P.).'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Hoffmann', 'Affiliation': 'Department of Radiology (U.H.), Massachusetts General Hospital, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (A.G., N.P., C.L.H., B.A., D.B.M., P.S.D.).'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (A.G., N.P., C.L.H., B.A., D.B.M., P.S.D.).'}]",Circulation. Cardiovascular imaging,['10.1161/CIRCIMAGING.119.009986'] 71,31104282,"Impact of Biliopancreatic Limb Length (70 cm vs 120 cm), with Constant 150 cm Alimentary Limb, on Long-Term Weight Loss, Remission of Comorbidities and Supplementation Needs After Roux-En-Y Gastric Bypass: a Prospective Randomized Clinical Trial.","BACKGROUND The best alimentary and biliopancreatic limb (BPL) lengths in the Roux-en-Y gastric bypass (RYGB) still remain unclear. The aim of this study was to compare the effect of a BPL of 70 vs 120 cm, with a constant AL of 150 cm on long-term weight loss, remission of comorbidities, and supplementation needs after RYGB. PATIENTS AND METHODS A prospective randomized study of morbidly obese patients undergoing RYGB was performed. Patients were randomized into two groups: those patients undergoing RYGB with a BPL of 70 cm (BPL 70 cm) and those ones undergoing RYGB with a BPL of 120 cm (BPL 120 cm). BMI, excess BMI loss (EBMIL), remission of comorbidities and specific vitamin and mineral supplementation needs at 1, 2, and 5 years were analyzed. RESULTS Two hundred fifty-three patients were included in each group. There were no significant differences in BMI, EBMIL and the remission of diabetes mellitus, hypertension, and dyslipidemia between groups at 1, 2, and 5 years after surgery. Patients from group BPL 120 cm required greater specific supplementation of vitamin B12, folic acid, and vitamin A during all the follow-up. CONCLUSION A RYGB with 120 cm BPL does not achieve greater weight loss or remission of comorbidities than a RYGB with 70 cm BPL but is associated with greater deficiencies of vitamin B12, vitamin A, and folic acid. TRIAL REGISTRATION ClinicalTrials.gov Identifier NCT03607305. https://clinicaltrials.gov/.",2019,"BPL does not achieve greater weight loss or remission of comorbidities than a RYGB with 70 cm BPL but is associated with greater deficiencies of vitamin B12, vitamin A, and folic acid. ","['Two hundred fifty-three patients were included in each group', 'morbidly obese patients undergoing']","['RYGB', 'RYGB with a BPL of 70\xa0cm (BPL 70\xa0cm) and those ones undergoing RYGB with a BPL', 'Biliopancreatic Limb Length', 'BPL', 'Roux-En-Y Gastric Bypass']","['BMI, EBMIL and the remission of diabetes mellitus, hypertension, and dyslipidemia', 'weight loss or remission of comorbidities', 'Long-Term Weight Loss, Remission of Comorbidities and Supplementation Needs', 'BMI, excess BMI loss (EBMIL), remission of comorbidities and specific vitamin and mineral supplementation needs', 'specific supplementation of vitamin B12, folic acid, and vitamin A']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C1261315', 'cui_str': 'Limb length'}, {'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C1384599', 'cui_str': 'Mineral supplement therapy'}, {'cui': 'C0042845', 'cui_str': 'cyanocobalamin'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}]",253.0,0.0981319,"BPL does not achieve greater weight loss or remission of comorbidities than a RYGB with 70 cm BPL but is associated with greater deficiencies of vitamin B12, vitamin A, and folic acid. ","[{'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Ruiz-Tovar', 'Affiliation': 'Centro de Excelencia para el Estudio y Tratamiento de la Obesidad, Valladolid, Spain. jruiztovar@gmail.com.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vorwald', 'Affiliation': 'Department of Surgery, Hospital Universitario Fundación Jimenez Diaz, Madrid, Spain.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'Gonzalez-Ramirez', 'Affiliation': 'Department of Bariatric Surgery. Hospital Angeles del Carmen, Universidad de Guadalajara, Guadalajara, Mexico.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Posada', 'Affiliation': 'Department of Surgery, Hospital Universitario Fundación Jimenez Diaz, Madrid, Spain.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Salcedo', 'Affiliation': 'Department of Bariatric Surgery. Hospital Angeles del Carmen, Universidad de Guadalajara, Guadalajara, Mexico.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Llavero', 'Affiliation': 'Department of Surgical Nursery, Hospital del Sureste, Madrid, Spain.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Garcia-Olmo', 'Affiliation': 'Department of Surgery, Hospital Universitario Fundación Jimenez Diaz, Madrid, Spain.'}]",Obesity surgery,['10.1007/s11695-019-03717-7'] 72,32297923,Effect of Face-Down Positioning vs Support-the-Break Positioning After Macula-Involving Retinal Detachment Repair: The PostRD Randomized Clinical Trial.,"Importance A lack of consensus exists with regard to the optimal positioning regimen for patients after macula-involving retinal detachment (RD) repair. Objective To evaluate the effect of face-down positioning vs support-the-break positioning on retinal displacement and distortion after macula-involving RD repair. Design, Setting, and Participants A prospective 6-month single-masked randomized clinical trial was conducted at a multicenter tertiary referral setting from May 16, 2016, to May 1, 2018. Inclusion criteria were fovea-involving rhegmatogenous RD; central visual loss within 14 days; patients undergoing primary vitrectomy and gas surgery, under local anesthetic; patients able to give written informed consent; and 18 years old and older. Analysis was conducted following a modified intention-to-treat principle, with patients experiencing a redetachment or failure to attach the macula being excluded from analysis. Interventions Participants were randomized 1:1 to receive face-down positioning or support-the-break positioning for a 24-hour period postoperatively. Positioning compliance was not monitored. Main Outcomes and Measures The proportion of patients with retinal displacement on autofluorescence imaging at 6 months postoperatively. Secondary outcomes included proportion of patients with displacement at 2 months; amplitude of displacement at 2 and 6 months; corrected Early Treatment Diabetic Retinopathy Study visual acuity; objective Distortion Scores; and quality of life questionnaire scores at 6 months. Results Of the 262 randomized patients, 239 were analyzed (171 male [71.5%]; mean [SD] age, 60.8 [9.8] years). At 6 months, retinal displacement was detected in 42 of 100 (42%) in the face-down positioning group vs 58 of 103 (56%) in the support-the-break positioning group (odds ratio, 1.77; 95%CI, 1.01-3.11; P = .04). The degree of displacement was lower in the face-down group. Groups were similar in corrected visual acuity (face-down, 74 letters vs support-the-break, 75 letters), objective D Chart Distortion Scores (range: 0, no distortion to 41.6, severe distortion; with face-down at 4.5 vs support-the-break at 4.2), and quality of life scores (face-down 89.3 vs support-the-break 89.0) at 2 and 6 months. Retinal redetachment rate was similar in both groups (face-down group, 12.2% and support-the-break group, 13.7%). Retinal folds were less common in the face-down positioning group vs the support-the-break positioning group (5.3% vs 13.5%, respectively; odds ratio, 2.8; 95% CI, 1.2-7.4; P = .03). Binocular diplopia was more common in the support-the-break group compared with the face-down positioning group (7.6% vs 1.5%, respectively; odds ratio, 5.3; 95% CI, 1.3-24.6; P = .03). Amplitude of displacement was associated with worse visual acuity (r = -0.5; P < .001) and distortion (r = 0.28; P = .008). Conclusions and Relevance In this study, findings suggest that face-down positioning was associated with a reduction in the rate and amplitude of postoperative retinal displacement after macula-involving RD repair and with a reduction in binocular diplopia. No association was found with visual acuity or postoperative distortion. Trial Registration ClinicalTrials.gov Identifier: NCT02748538.",2020,"Amplitude of displacement was associated with worse visual acuity (r = -0.5; P < .001) and distortion (r = 0.28; P = .008). ","['multicenter tertiary referral setting from May 16, 2016, to May 1, 2018', '239 were analyzed (171 male [71.5%]; mean [SD] age, 60.8 [9.8] years', 'Inclusion criteria were fovea-involving rhegmatogenous RD; central visual loss within 14 days; patients undergoing primary vitrectomy and gas surgery, under local anesthetic; patients able to give written informed consent; and 18 years old and older', 'patients after macula-involving retinal detachment (RD) repair', 'patients experiencing a redetachment or failure to attach the macula being excluded from analysis', '262 randomized patients']","['face-down positioning vs support-the-break positioning', 'Face-Down Positioning vs Support-the-Break Positioning', 'Macula-Involving Retinal Detachment Repair', 'face-down positioning or support-the-break positioning for a 24-hour period postoperatively']","['visual acuity or postoperative distortion', 'worse visual acuity', 'Retinal redetachment rate', 'degree of displacement', 'quality of life scores', 'retinal displacement', 'Binocular diplopia', 'corrected visual acuity', 'proportion of patients with displacement at 2 months; amplitude of displacement at 2 and 6 months; corrected Early Treatment Diabetic Retinopathy Study visual acuity; objective Distortion Scores; and quality of life questionnaire scores', 'objective D Chart Distortion Scores (range']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0303720', 'cui_str': 'Americium-239'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0016622', 'cui_str': 'Structure of fovea centralis'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0271055', 'cui_str': 'Rhegmatogenous retinal detachment'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0227662', 'cui_str': 'Structure of macula densa'}, {'cui': 'C0035305', 'cui_str': 'Retinal detachment'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0227662', 'cui_str': 'Structure of macula densa'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0197839', 'cui_str': 'Repair of retina for retinal detachment'}, {'cui': 'C0439584', 'cui_str': '24 hours'}]","[{'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030976', 'cui_str': 'Distortions, Perceptual'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0422985', 'cui_str': 'Binocular diplopia'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",262.0,0.188557,"Amplitude of displacement was associated with worse visual acuity (r = -0.5; P < .001) and distortion (r = 0.28; P = .008). ","[{'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Casswell', 'Affiliation': 'Department of Ophthalmology, Moorfields Eye Hospital, London, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Yorston', 'Affiliation': 'Tennent Institute of Ophthalmology, Gartnavel Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': 'Department of Ophthalmology, Moorfields Eye Hospital, London, United Kingdom.'}, {'ForeName': 'Tjebo F C', 'Initials': 'TFC', 'LastName': 'Heeren', 'Affiliation': 'Department of Ophthalmology, Moorfields Eye Hospital, London, United Kingdom.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Harris', 'Affiliation': 'Department of Ophthalmology, Moorfields Eye Hospital, London, United Kingdom.'}, {'ForeName': 'Tapiwa Margaret', 'Initials': 'TM', 'LastName': 'Zvobgo', 'Affiliation': 'Department of Ophthalmology, Moorfields Eye Hospital, London, United Kingdom.'}, {'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Tarafdar', 'Affiliation': 'Tennent Institute of Ophthalmology, Gartnavel Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Xing', 'Affiliation': 'Department of Ophthalmology, Moorfields Eye Hospital, London, United Kingdom.'}, {'ForeName': 'Elli', 'Initials': 'E', 'LastName': 'Bourmpaki', 'Affiliation': ""Unit of Medical Statistics, Faculty of Life Sciences, King's College London School of Population Health & Environmental Sciences, London, United Kingdom.""}, {'ForeName': 'Catey', 'Initials': 'C', 'LastName': 'Bunce', 'Affiliation': ""Unit of Medical Statistics, Faculty of Life Sciences, King's College London School of Population Health & Environmental Sciences, London, United Kingdom.""}, {'ForeName': 'Pearse', 'Initials': 'P', 'LastName': 'Keane', 'Affiliation': 'Department of Ophthalmology, Moorfields Eye Hospital, London, United Kingdom.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Charteris', 'Affiliation': 'Department of Ophthalmology, Moorfields Eye Hospital, London, United Kingdom.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.0997'] 73,31799616,Multielectrode Transcranial Electrical Stimulation of the Left and Right Prefrontal Cortices Differentially Impacts Verbal Working Memory Neural Circuitry.,"Recent studies have examined the effects of conventional transcranial direct current stimulation (tDCS) on working memory (WM) performance, but this method has relatively low spatial precision and generally involves a reference electrode that complicates interpretation. Herein, we report a repeated-measures crossover study of 25 healthy adults who underwent multielectrode tDCS of the left dorsolateral prefrontal cortex (DLPFC), right DLPFC, or sham in 3 separate visits. Shortly after each stimulation session, participants performed a verbal WM (VWM) task during magnetoencephalography, and the resulting data were examined in the time-frequency domain and imaged using a beamformer. We found that after left DLPFC stimulation, participants exhibited stronger responses across a network of left-lateralized cortical areas, including the supramarginal gyrus, prefrontal cortex, inferior frontal gyrus, and cuneus, as well as the right hemispheric homologues of these regions. Importantly, these effects were specific to the alpha-band, which has been previously implicated in VWM processing. Although stimulation condition did not significantly affect performance, stepwise regression revealed a relationship between reaction time and response amplitude in the left precuneus and supramarginal gyrus. These findings suggest that multielectrode tDCS targeting the left DLPFC affects the neural dynamics underlying offline VWM processing, including utilization of a more extensive bilateral cortical network.",2020,"Although stimulation condition did not significantly affect performance, stepwise regression revealed a relationship between reaction time and response amplitude in the left precuneus and supramarginal gyrus.","['25 healthy adults who underwent multielectrode tDCS of the left dorsolateral prefrontal cortex (DLPFC), right DLPFC, or sham in 3 separate visits']",['conventional transcranial direct current stimulation (tDCS'],"['working memory (WM) performance', 'reaction time and response amplitude']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",25.0,0.0283869,"Although stimulation condition did not significantly affect performance, stepwise regression revealed a relationship between reaction time and response amplitude in the left precuneus and supramarginal gyrus.","[{'ForeName': 'Sam M', 'Initials': 'SM', 'LastName': 'Koshy', 'Affiliation': 'Center for Magnetoencephalography, University of Nebraska Medical Center, Omaha, NE 68198, USA.'}, {'ForeName': 'Alex I', 'Initials': 'AI', 'LastName': 'Wiesman', 'Affiliation': 'Center for Magnetoencephalography, University of Nebraska Medical Center, Omaha, NE 68198, USA.'}, {'ForeName': 'Rachel K', 'Initials': 'RK', 'LastName': 'Spooner', 'Affiliation': 'Center for Magnetoencephalography, University of Nebraska Medical Center, Omaha, NE 68198, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Embury', 'Affiliation': 'Center for Magnetoencephalography, University of Nebraska Medical Center, Omaha, NE 68198, USA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Rezich', 'Affiliation': 'Center for Magnetoencephalography, University of Nebraska Medical Center, Omaha, NE 68198, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Heinrichs-Graham', 'Affiliation': 'Center for Magnetoencephalography, University of Nebraska Medical Center, Omaha, NE 68198, USA.'}, {'ForeName': 'Tony W', 'Initials': 'TW', 'LastName': 'Wilson', 'Affiliation': 'Center for Magnetoencephalography, University of Nebraska Medical Center, Omaha, NE 68198, USA.'}]","Cerebral cortex (New York, N.Y. : 1991)",['10.1093/cercor/bhz246'] 74,32317241,Conventional vs machine learning-based treatment planning in prostate brachytherapy: Results of a Phase I randomized controlled trial.,"PURPOSE The purpose of this study was to evaluate the noninferiority of Day 30 dosimetry between a machine learning-based treatment planning system for prostate low-dose-rate (LDR) brachytherapy and the conventional, manual planning technique. As a secondary objective, the impact of planning technique on clinical workflow efficiency was also evaluated. MATERIALS AND METHODS 41 consecutive patients who underwent I-125 LDR monotherapy for low- and intermediate-risk prostate cancer were accrued into this single-institution study between 2017 and 2018. Patients were 1:1 randomized to receive treatment planning using a machine learning-based prostate implant planning algorithm (PIPA system) or conventional, manual technique. Treatment plan modifications by the radiation oncologist were evaluated by computing the Dice coefficient of the prostate V 150% isodose volume between either the PIPA-or conventional-and final approved plans. Additional evaluations between groups evaluated the total planning time and dosimetric outcomes at preimplant and Day 30. RESULTS 21 and 20 patients were treated using the PIPA and conventional techniques, respectively. No significant differences were observed in preimplant or Day 30 prostate D 90% , V 100% , rectum V 100 , or rectum D 1cc between PIPA and conventional techniques. Although the PIPA group had a larger proportion of patients with plans requiring no modifications (Dice = 1.00), there was no significant difference between the magnitude of modifications between each arm. There was a large significant advantage in mean planning time for the PIPA arm (2.38 ± 0.96 min) compared with the conventional (43.13 ± 58.70 min) technique (p >> 0.05). CONCLUSIONS A machine learning-based planning workflow for prostate LDR brachytherapy has the potential to offer significant time savings and operational efficiencies, while producing noninferior postoperative dosimetry to that of expert, conventional treatment planners.",2020,"No significant differences were observed in preimplant or Day 30 prostate D 90% , V 100% , rectum V 100 , or rectum D 1cc between PIPA and conventional techniques.","['for low- and intermediate-risk prostate cancer were accrued into this single-institution study between 2017 and 2018', '41 consecutive patients who underwent']","['Conventional vs machine learning-based treatment planning in prostate brachytherapy', 'machine learning-based prostate implant planning algorithm (PIPA system) or conventional, manual technique', 'machine learning-based treatment planning system for prostate low-dose-rate (LDR) brachytherapy and the conventional, manual planning technique', 'I-125 LDR monotherapy', 'PIPA']","['clinical workflow efficiency', 'mean planning time', 'total planning time and dosimetric outcomes']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0854662', 'cui_str': 'Brachytherapy to prostate'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0006098', 'cui_str': 'Brachytherapy'}, {'cui': 'C0032076', 'cui_str': 'Planning Methodology'}, {'cui': 'C0796396', 'cui_str': 'Iodine-125'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1710679', 'cui_str': 'Work Flow'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",41.0,0.0160555,"No significant differences were observed in preimplant or Day 30 prostate D 90% , V 100% , rectum V 100 , or rectum D 1cc between PIPA and conventional techniques.","[{'ForeName': 'Alexandru', 'Initials': 'A', 'LastName': 'Nicolae', 'Affiliation': 'Department of Medical Physics, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Semple', 'Affiliation': 'Department of Medical Physics, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Department of Radiation Therapy, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Smith', 'Affiliation': 'Department of Radiation Therapy, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Chung', 'Affiliation': 'Department of Radiation Oncology, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Loblaw', 'Affiliation': 'Department of Radiation Oncology, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Morton', 'Affiliation': 'Department of Radiation Oncology, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Lucas Castro', 'Initials': 'LC', 'LastName': 'Mendez', 'Affiliation': 'Department of Radiation Oncology, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Chia-Lin', 'Initials': 'CL', 'LastName': 'Tseng', 'Affiliation': 'Department of Radiation Oncology, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Davidson', 'Affiliation': 'Department of Medical Physics, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Ananth', 'Initials': 'A', 'LastName': 'Ravi', 'Affiliation': 'Department of Medical Physics, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada. Electronic address: ananth.ravi@sunnybrook.ca.'}]",Brachytherapy,['10.1016/j.brachy.2020.03.004'] 75,32314828,HCC recurrence in HCV-infected patients after liver transplantation: SiLVER Study reveals benefits of sirolimus in combination with CNIs - a post-hoc analysis.,"Factors affecting outcomes in liver transplant (LTx) recipients with hepatocellular carcinoma (HCC) and hepatitis C viral (HCV) infection include the choice of immunosuppression. Here, we analyzed the HCV + subgroup of patients from the randomized controlled, international SiLVER Study. We performed a post hoc analysis of 166 HCV + SiLVER Study patients regarding HCC outcome after LTx. Control patients (group A: n = 88) received mTOR inhibitor (mTORi)-free, calcineurin inhibitor (CNI)-based versus sirolimus-based immunosuppression (group B: n = 78). We found no significant difference regarding HCV-RNA titers between group A and B. Since no effect in group B could be due to variable sirolimus dosing, we split group B into patients receiving sirolimus-based immunosuppression + CNIs for >50% (B1; n = 44) or <50% (B2; n = 34) of the time. While there remained no difference in HCV-RNA titer between groups, HCC recurrence-free survival in group B1 (81.8%) was markedly better versus both group A (62.7%; P = 0.0136) and group B2 (64.7%; P = 0.0326); Interestingly, further subgroup analysis revealed an increase (P = 0.0012) in liver enzyme values in group B2. Taken together, in HCV-infected patients with HCC and LTx, mTORi immunosuppression + CNIs yields excellent outcomes. Unexpectedly, higher levels of liver inflammation and poorer outcomes occur with mTORi monotherapy in the HCV + subgroup.",2020,"While there remained no difference in HCV-RNA titer between groups, HCC recurrence-free survival in group B1 (81.8%) was markedly better versus both group A (62.7%; P=0.0136) and group B2 (64.7%; P=0.0326); Interestingly, further subgroup analysis revealed an increase (P=0.0012) in liver-enzyme values in group B2. ","['Control patients (group A: n=88) received', 'liver transplant (LTx) recipients with hepatocellular carcinoma (HCC) and hepatitis C viral (HCV) infection', 'HCV patients after liver transplantation', '166 HCV + SiLVER Study patients regarding HCC outcome after LTx']","['sirolimus-based immunosuppression + CNIs', 'sirolimus', 'mTOR inhibitor (mTORi)-free, calcineurin inhibitor (CNI)-based versus sirolimus-based immunosuppression']","['liver inflammation', 'HCV-RNA titer', 'liver-enzyme values', 'HCV-RNA titers', 'HCC recurrence', 'HCC recurrence-free survival']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0455647', 'cui_str': 'H/O: liver recipient'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0037125', 'cui_str': 'silver'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C1307407', 'cui_str': 'FRAP1 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1453118', 'cui_str': 'CABIN1 protein, human'}]","[{'cui': 'C0019158', 'cui_str': 'Inflammatory disease of liver'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}]",,0.0596776,"While there remained no difference in HCV-RNA titer between groups, HCC recurrence-free survival in group B1 (81.8%) was markedly better versus both group A (62.7%; P=0.0136) and group B2 (64.7%; P=0.0326); Interestingly, further subgroup analysis revealed an increase (P=0.0012) in liver-enzyme values in group B2. ","[{'ForeName': 'Jens M', 'Initials': 'JM', 'LastName': 'Werner', 'Affiliation': 'Department of Surgery, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Hornung', 'Affiliation': 'Department of Surgery, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Rubertha', 'Initials': 'R', 'LastName': 'Krah', 'Affiliation': 'Department of Surgery, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Götz', 'Affiliation': 'Department of Surgery, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Andreas A', 'Initials': 'AA', 'LastName': 'Schnitzbauer', 'Affiliation': 'Department of Surgery, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Schlitt', 'Affiliation': 'Department of Surgery, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Geissler', 'Affiliation': 'Department of Surgery, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Transplant international : official journal of the European Society for Organ Transplantation,['10.1111/tri.13621'] 76,32310145,Effectiveness of a Web-Based Intervention to Support Medication Adherence Among People Living With HIV: Web-Based Randomized Controlled Trial.,"BACKGROUND Taking antiretroviral therapy (ART) is part of the daily life of people living with HIV. Different electronic health (eHealth) initiatives adjunctive to usual care have been proposed to support optimal medication adherence. A web-based intervention called HIV Treatment, Virtual Nursing Assistance, and Education or VIH-TAVIE (from its French version Virus de l'immunodéficience humaine-Traitement assistance virtuelle infirmière et enseignement) was developed to empower people living with HIV to manage their ART and symptoms optimally. OBJECTIVE We aimed to evaluate the effectiveness of VIH-TAVIE in a web-based randomized controlled trial (RCT). METHODS This RCT was entirely web-based, including recruitment, consent granting, questionnaire completion, and intervention exposure (consultation with VIH-TAVIE [experimental group] or websites [control group]). To be eligible for the study, people living with HIV had to be 18 years or older, be on ART for at least 6 months, have internet access, and have internet literacy. Participants were randomly assigned to either the experimental group (n=45) or control group (n=43). The primary outcome was ART adherence. The secondary outcomes included self-efficacy regarding medication intake, symptom-related discomfort, skills and strategies, and social support. All outcomes were measured with a self-administered web-based questionnaire at the following three time points: baseline and 3 and 6 months later. A generalized linear mixed model was built to assess the evolution of ART adherence over time in both groups. RESULTS The sample included 88 participants, and of these, 73 (83%) were men. The median age of the participants was 42 years. Participants had been diagnosed with HIV a median of 7 years earlier (IQR 3-17) and had been on ART for a median of 5 years (IQR 2-12). The proportion of treatment-adherent participants at baseline was high in both groups (34/41, 83% in the experimental group and 30/39, 77% in the control group). Participants also reported high treatment adherence, high self-efficacy, and high skills; perceived good social support; and experienced low discomfort from symptoms. Analyses revealed no intergroup difference regarding ART adherence (OR 1.9, 95% CI 0.6-6.4). CONCLUSIONS This study highlights the challenges and lessons learned from conducting an entirely web-based RCT among people living with HIV. The challenges were related to the engagement of people living with HIV on the following three levels: starting the web-based study (recruitment), completing the web-based intervention (engagement), and continuing the study (retention). The results contribute to the existing body of knowledge regarding how to conduct web-based evaluation studies of eHealth interventions aimed at developing and strengthening personal skills and abilities. TRIAL REGISTRATION ClinicalTrials.gov NCT01510340; https://clinicaltrials.gov/ct2/show/NCT01510340.",2020,"The secondary outcomes included self-efficacy regarding medication intake, symptom-related discomfort, skills and strategies, and social support.","['people living with HIV', 'The sample included 88 participants, and of these, 73 (83%) were men', 'Participants had been diagnosed with HIV a median of 7 years earlier (IQR 3-17) and had been on ART for a median of 5 years (IQR 2-12', 'people living with HIV had to be 18 years or older, be on ART for at least 6 months, have internet access, and have internet literacy', 'People Living With HIV']","['Web-Based Intervention', 'VIH-TAVIE', 'antiretroviral therapy (ART']","['self-efficacy regarding medication intake, symptom-related discomfort, skills and strategies, and social support', 'ART adherence']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4704731', 'cui_str': 'Internet Access'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",88.0,0.218067,"The secondary outcomes included self-efficacy regarding medication intake, symptom-related discomfort, skills and strategies, and social support.","[{'ForeName': 'José', 'Initials': 'J', 'LastName': 'Côté', 'Affiliation': ""Research Centre of the Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.""}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': 'Rouleau', 'Affiliation': ""Research Centre of the Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.""}, {'ForeName': 'Maria Pilar', 'Initials': 'MP', 'LastName': 'Ramirez-Garcia', 'Affiliation': ""Research Centre of the Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Auger', 'Affiliation': ""Research Centre of the Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.""}, {'ForeName': 'Réjean', 'Initials': 'R', 'LastName': 'Thomas', 'Affiliation': ""Clinique médicale l'Actuel, Montreal, QC, Canada.""}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Leblanc', 'Affiliation': ""Research Centre of the Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.""}]",JMIR public health and surveillance,['10.2196/17733'] 77,32295417,Effects of Acute Colchicine Administration Prior to Percutaneous Coronary Intervention: COLCHICINE-PCI Randomized Trial.,"BACKGROUND Vascular injury and inflammation during percutaneous coronary intervention (PCI) are associated with increased risk of post-PCI adverse outcomes. Colchicine decreases neutrophil recruitment to sites of vascular injury. The anti-inflammatory effects of acute colchicine administration before PCI on subsequent myocardial injury are unknown. METHODS In a prospective, single-site trial, subjects referred for possible PCI (n=714) were randomized to acute preprocedural oral administration of colchicine 1.8 mg or placebo. RESULTS Among the 400 subjects who underwent PCI, the primary outcome of PCI-related myocardial injury did not differ between colchicine (n=206) and placebo (n=194) groups (57.3% versus 64.2%, P =0.19). The composite outcome of death, nonfatal myocardial infarction, and target vessel revascularization at 30 days (11.7% versus 12.9%, P =0.82), and the outcome of PCI-related myocardial infarction defined by the Society for Cardiovascular Angiography and Interventions (2.9% versus 4.7%, P =0.49) did not differ between colchicine and placebo groups. Among 280 PCI subjects in a nested inflammatory biomarker substudy, the primary biomarker end point, change in interleukin-6 concentrations did not differ between groups 1-hour post-PCI but increased less 24 hours post-PCI in the colchicine (n=141) versus placebo group (n=139; 76% [-6 to 898] versus 338% [27 to 1264], P =0.02). High-sensitivity C-reactive protein concentration also increased less after 24 hours in the colchicine versus placebo groups (11% [-14 to 80] versus 66% [1 to 172], P =0.001). CONCLUSIONS Acute preprocedural administration of colchicine attenuated the increase in interleukin-6 and high-sensitivity C-reactive protein concentrations after PCI when compared with placebo but did not lower the risk of PCI-related myocardial injury. Registration: URL: https://www.clinicaltrials.gov; Unique Identifiers: NCT02594111, NCT01709981.",2020,"High-sensitivity C-reactive protein concentration also increased less after 24 hours in the colchicine versus placebo groups (11% [-14 to 80] versus 66% [1 to 172], P =0.001). ","['400 subjects who underwent', '280 PCI subjects', 'subjects referred for possible PCI (n=714']","['colchicine', 'PCI', 'percutaneous coronary intervention (PCI', 'placebo', 'colchicine 1.8 mg or placebo', 'Acute Colchicine Administration', 'Colchicine']","['interleukin-6 and high-sensitivity C-reactive protein concentrations', 'PCI-related myocardial injury', 'change in interleukin-6 concentrations', 'death, nonfatal myocardial infarction, and target vessel revascularization', 'outcome of PCI-related myocardial infarction defined by the Society for Cardiovascular Angiography and Interventions', 'High-sensitivity C-reactive protein concentration']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0332149', 'cui_str': 'Possible'}]","[{'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C1321565', 'cui_str': 'Cardiovascular angiography'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",714.0,0.63533,"High-sensitivity C-reactive protein concentration also increased less after 24 hours in the colchicine versus placebo groups (11% [-14 to 80] versus 66% [1 to 172], P =0.001). ","[{'ForeName': 'Binita', 'Initials': 'B', 'LastName': 'Shah', 'Affiliation': 'Section of Cardiology, Department of Medicine (B.S., J.D.L., N.R.S.), VA New York Harbor Health Care System.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pillinger', 'Affiliation': 'Section of Rheumatology, Department of Medicine (M.P.), VA New York Harbor Health Care System.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zhong', 'Affiliation': 'Division of Biostatistics, Department of Population Health (H.Z., Y.X.), New York University School of Medicine.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Cronstein', 'Affiliation': 'Division of Rheumatology, Department of Medicine (M.P., B.C.), New York University School of Medicine.'}, {'ForeName': 'Yuhe', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': 'Division of Biostatistics, Department of Population Health (H.Z., Y.X.), New York University School of Medicine.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Lorin', 'Affiliation': 'Section of Cardiology, Department of Medicine (B.S., J.D.L., N.R.S.), VA New York Harbor Health Care System.'}, {'ForeName': 'Nathaniel R', 'Initials': 'NR', 'LastName': 'Smilowitz', 'Affiliation': 'Section of Cardiology, Department of Medicine (B.S., J.D.L., N.R.S.), VA New York Harbor Health Care System.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Feit', 'Affiliation': 'Division of Cardiology, Department of Medicine (B.S., J.D.L., N.R.S., F.F., N.R., N.M.K., S.D.K.), New York University School of Medicine.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Ratnapala', 'Affiliation': 'Division of Cardiology, Department of Medicine (B.S., J.D.L., N.R.S., F.F., N.R., N.M.K., S.D.K.), New York University School of Medicine.'}, {'ForeName': 'Norma M', 'Initials': 'NM', 'LastName': 'Keller', 'Affiliation': 'Division of Cardiology, Department of Medicine (B.S., J.D.L., N.R.S., F.F., N.R., N.M.K., S.D.K.), New York University School of Medicine.'}, {'ForeName': 'Stuart D', 'Initials': 'SD', 'LastName': 'Katz', 'Affiliation': 'Division of Cardiology, Department of Medicine (B.S., J.D.L., N.R.S., F.F., N.R., N.M.K., S.D.K.), New York University School of Medicine.'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.008717'] 78,31616941,The circadian system modulates the rate of recovery of systolic blood pressure after exercise in humans.,"STUDY OBJECTIVES Recovery rates of systolic blood pressure (BP) and heart rate (HR) after exercise have been used to assess cardiovascular fitness, and slower recovery rates are predictors of coronary heart disease and cardiac mortality. The endogenous circadian system is known to modulate BP and HR at rest and during exercise. Here, we examined whether the post-exercise recovery rates of BP and HR are also under circadian control. METHODS Twelve healthy adults (mean age = 26 ± 6 (SD) years; 6 female) participated in a 240 h forced desynchrony protocol in dim light where all behaviors, including 15 min cycle exercise tests at 60% maximal HR, were uniformly distributed across the circadian cycle. Circadian phases were assigned based on the rhythm of core body temperature. For each session, HR was measured continuously, and BP every 3-5 min throughout baseline, exercise, and recovery. Recovery was quantified as the proportional return to pre-exercise baseline levels following exercise ([peak exercise-recovery]/[peak exercise-baseline) × 100%], whereby 100% represents full recovery to baseline). RESULTS There was a significant circadian rhythm in systolic BP recovery, with fastest recovery at the circadian phase corresponding to late afternoon (equivalent to ~5 pm) and slower recovery across the early morning (~8:30 am; p = 0.029, peak-to-trough: 9.2%). There were no significant circadian variations in post-exercise recovery rates of diastolic BP or HR. CONCLUSIONS The circadian system modulates the rate of recovery of systolic BP after exercise with fastest recovery in the biological afternoon. These data could have implications for exercise prescription and interpretation of clinical tests of stress recovery.",2020,"There were no significant circadian variations in post-exercise recovery rates of diastolic BP or HR. ","['12 healthy adults (mean age = 26±6 (SD) years; 6 female', 'humans']",['240-h forced desynchrony protocol in dim light'],"['diastolic BP or HR', 'systolic blood pressure (BP) and heart rate (HR', 'circadian rhythm in systolic BP recovery', 'cardiovascular fitness', 'rate of recovery of systolic BP', 'systolic blood pressure']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0008810', 'cui_str': 'Nycthemeral Rhythm'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",12.0,0.134676,"There were no significant circadian variations in post-exercise recovery rates of diastolic BP or HR. ","[{'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Qian', 'Affiliation': ""Medical Chronobiology Program, Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Frank Ajl', 'Initials': 'FA', 'LastName': 'Scheer', 'Affiliation': ""Medical Chronobiology Program, Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Hu', 'Affiliation': ""Medical Chronobiology Program, Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Shea', 'Affiliation': 'Oregon Institute of Occupational Health Sciences, Oregon Health and Science University, Portland, OR.'}]",Sleep,['10.1093/sleep/zsz253'] 79,32314298,Comparative Study of Traditional Ablative CO 2 Laser-Assisted Topical Antifungal with only Topical Antifungal for Treating Onychomycosis: A Multicenter Study.,"BACKGROUND The predominance of onychomycosis has been increasing recently. New medications and treatment modalities are being researched for better saturation of the antifungal agents through the nail plate topically because of the low resilience of some patients for the oral antifungal agents. Treatment of onychomycosis, mainly moderate to severe, can be very challenging, expensive, and time consuming. OBJECTIVE The objective of this clinical trial is to compare the efficacy and safety of a manually operated ablative CO 2 laser combined with a topical antifungal agent in patients with onychomycosis. STUDY DESIGN We conducted an open-label controlled prospective study of 160 eligible patients randomized into control and treatment groups with a 1:1 allocation in the department of dermatology in five different hospitals in Shanghai. It was a 6-month study where both groups were treated with a topical antifungal agent, with the treatment group also receiving ablation by the traditional CO 2 laser once a month for the first 3 months. RESULTS The clinical efficacy and mycological cure rate were significantly higher (p < 0.001) for the treatment group. Three (3.75%) patients from the control group and 18 (25%) patients from the treatment group achieved complete nail clearance along with negative potassium hydroxide and negative culture (primary endpoint) results at 24 weeks. Mycological clearance with at least moderate nail clearance (secondary endpoint) for the treatment group was also significantly higher (p < 0.001) for the laser treatment group. The laser treatment was mildly painful but tolerable by the patients. No drug interactions for both groups were encountered. CONCLUSIONS The ablative CO 2 laser is a primitive yet effective modality to be considered for the delivery of topical antifungal agents for the management of mild-to-severe onychomycosis. The laser has good tolerance in patients and is a common equipment found in most dermatology units even those without the latest medical technology.",2020,The clinical efficacy and mycological cure rate were significantly higher (p < 0.001) for the treatment group.,"['Treating Onychomycosis', '160 eligible patients randomized into control and treatment groups with a 1:1 allocation in the department of dermatology in five different hospitals in Shanghai', 'patients with onychomycosis']",['Traditional Ablative CO 2 Laser-Assisted Topical Antifungal with only Topical Antifungal'],"['Mycological clearance', 'clinical efficacy and mycological cure rate', 'efficacy and safety', 'nail clearance', 'complete nail clearance']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0040261', 'cui_str': 'Onychomycosis'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0003308', 'cui_str': 'Antifungal-containing product'}]","[{'cui': 'C0205467', 'cui_str': 'Mycologic'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",160.0,0.017543,The clinical efficacy and mycological cure rate were significantly higher (p < 0.001) for the treatment group.,"[{'ForeName': 'Bhavana', 'Initials': 'B', 'LastName': 'Rajbanshi', 'Affiliation': 'Department of Dermatology and Venereology, Shanghai Tongji Hospital, Tongji University School of Medicine, 398 Xincun road, Putou District, Shanghai, China.'}, {'ForeName': 'Liangliang', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Dermatology and Venereology, Shanghai Tongji Hospital, Tongji University School of Medicine, 398 Xincun road, Putou District, Shanghai, China.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Department of Dermatology and Venereology, Shanghai Tongji Hospital, Tongji University School of Medicine, 398 Xincun road, Putou District, Shanghai, China.'}, {'ForeName': 'Qingyu', 'Initials': 'Q', 'LastName': 'Gao', 'Affiliation': 'Department of Dermatology and Venereology, Shanghai Tongji Hospital, Tongji University School of Medicine, 398 Xincun road, Putou District, Shanghai, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Department of Dermatology and Venereology, Shanghai Tongji Hospital, Tongji University School of Medicine, 398 Xincun road, Putou District, Shanghai, China.'}, {'ForeName': 'Jiaoyang', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Dermatology and Venereology, Putuo District Central Hospital, Shanghai, China.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Dermatology and Venereology, Jiading District Anting Hospital, Shanghai, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Dermatology and Venereology, Jiading District Nanxiang Hospital, Shanghai, China.'}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Lv', 'Affiliation': 'Department of Dermatology and Venereology, Jiading District Central Hospital, Shanghai, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Dermatology and Venereology, Shanghai Tongji Hospital, Tongji University School of Medicine, 398 Xincun road, Putou District, Shanghai, China.'}, {'ForeName': 'Jingjun', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Dermatology and Venereology, Shanghai Tongji Hospital, Tongji University School of Medicine, 398 Xincun road, Putou District, Shanghai, China. zhaojingjun2015@aliyun.com.'}]",Clinical drug investigation,['10.1007/s40261-020-00914-6'] 80,29332989,Art Therapy and Cognitive Processing Therapy for Combat-Related PTSD: A Randomized Controlled Trial.,"This randomized controlled trial was designed to determine if art therapy in conjunction with Cognitive Processing Therapy (CPT) was more effective for reducing symptoms of combat posttraumatic stress disorder (PTSD) than CPT alone. Veterans ( N = 11) were randomized to receive either individual CPT, or individual CPT in conjunction with individual art therapy. PTSD Checklist-Military Version and Beck Depression Inventory-II scores improved with treatment in both groups with no significant difference in improvement between the experimental and control groups. Art therapy in conjunction with CPT was found to improve trauma processing and veterans considered it to be an important part of their treatment as it provided healthy distancing, enhanced trauma recall, and increased access to emotions.",2016,PTSD Checklist-Military Version and Beck Depression Inventory-II scores improved with treatment in both groups with no significant difference in improvement between the experimental and control groups.,"['Veterans ( N = 11', 'Combat-Related PTSD']","['Cognitive Processing Therapy (CPT', 'individual CPT, or individual CPT in conjunction with individual art therapy', 'Art Therapy and Cognitive Processing Therapy']",['PTSD Checklist-Military Version and Beck Depression Inventory-II scores'],"[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521399', 'cui_str': 'LT'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0003827', 'cui_str': 'Art Therapy'}]","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4273555', 'cui_str': 'BDI-II (Beck Depression Inventory Second Edition) score'}]",11.0,0.0332411,PTSD Checklist-Military Version and Beck Depression Inventory-II scores improved with treatment in both groups with no significant difference in improvement between the experimental and control groups.,"[{'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Campbell', 'Affiliation': 'Art therapist at the University Neuro-psychiatric Institute, University of Utah, Salt Lake City.'}, {'ForeName': 'Kathleen P', 'Initials': 'KP', 'LastName': 'Decker', 'Affiliation': 'Staff psychiatrist at the Hampton VA Medical Center, Hampton, VA, and faculty member in the Department of Psychiatry at Eastern Virginia Medical School, Norfolk.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Kruk', 'Affiliation': 'Community faculty.'}, {'ForeName': 'Sarah P', 'Initials': 'SP', 'LastName': 'Deaver', 'Affiliation': 'Professor in the Graduate Art Therapy and Counseling Professions Program, Eastern Virginia Medical School.'}]",Art therapy : journal of the American Art Therapy Association,['10.1080/07421656.2016.1226643'] 81,31066013,"A Multicenter, Randomized, Open-Label Study to Compare Micafungin with Fluconazole in the Prophylaxis of Invasive Fungal Infections in Living-Donor Liver Transplant Recipients.","BACKGROUND Although invasive fungal infections (IFIs) contribute to substantial morbidity and mortality in liver transplant recipients, only a few randomized studies analyzed the results of antifungal prophylaxis with echinocandins. The aim of this open-label, non-inferiority study was to evaluate the efficacy and safety of micafungin in the prophylaxis of IFIs in living-donor liver transplantation recipients (LDLTRs), with fluconazole as the comparator. METHODS LDLTRs (N = 172) from five centers were randomized 1:1 to receive intravenous micafungin 100 mg/day or fluconazole 100~200 mg/day (intravenous or oral). A non-inferiority of micafungin was tested against fluconazole. RESULTS The per-protocol set included 144 patients without major clinical trial protocol violations: 69 from the micafungin group and 75 from the fluconazole group. Mean age of the study patients was 54.2 years and mean model for end-stage liver disease (MELD) score amounted to 16.5. Clinical success rates in the micafungin and fluconazole groups were 95.65% and 96.10%, respectively (difference: - 0.45%; 90% confidence interval [CI]: - 6.93%, 5.59%), which demonstrated micafungin's non-inferiority (the lower bound for the 90% CI exceeded - 10%). The study groups did not differ significantly in terms of the secondary efficacy endpoints: absence of IFIs at the end of the prophylaxis and the end of the study, time to proven IFI, fungal-free survival, and adverse reactions. A total of 17 drug-related adverse events were observed in both groups; none of them was serious and all resolved. CONCLUSION Micafungin can be used as an alternative to fluconazole in the prevention of IFIs in LDLTRs. CLINICAL TRIALS REGISTRATION NCT01974375.",2020,"A total of 17 drug-related adverse events were observed in both groups; none of them was serious and all resolved. ","['Mean age of the study patients was 54.2\xa0years and mean model for end-stage liver disease (MELD) score amounted to 16.5', 'LDLTRs (N\u2009=\u2009172) from five centers', 'Living-Donor Liver Transplant Recipients', '144 patients without major clinical trial protocol violations: 69 from the micafungin group and 75 from the fluconazole group', 'living-donor liver transplantation recipients (LDLTRs', 'liver transplant recipients']","['intravenous micafungin 100\xa0mg/day or fluconazole 100~200\xa0mg/day (intravenous or oral', 'Micafungin with Fluconazole', 'micafungin', 'Micafungin', 'fluconazole']","['adverse events', 'secondary efficacy endpoints: absence of IFIs at the end of the prophylaxis and the end of the study, time to proven IFI, fungal-free survival, and adverse reactions', 'Clinical success rates', 'efficacy and safety']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517808', 'cui_str': '54.2 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4048785', 'cui_str': 'MELD score'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C3544287', 'cui_str': 'Living donor liver transplant'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2599718', 'cui_str': 'Trial Protocols'}, {'cui': 'C1120386', 'cui_str': 'micafungin'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C0348050', 'cui_str': 'Living Donors'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}, {'cui': 'C3811922', 'cui_str': 'Transplanted liver present (finding)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1120386', 'cui_str': 'micafungin'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",144.0,0.0550284,"A total of 17 drug-related adverse events were observed in both groups; none of them was serious and all resolved. ","[{'ForeName': 'Woo-Hyoung', 'Initials': 'WH', 'LastName': 'Kang', 'Affiliation': 'Division of Liver Transplantation and Hepatobiliary Surgery, Department of Surgery, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, South Korea.'}, {'ForeName': 'Gi-Won', 'Initials': 'GW', 'LastName': 'Song', 'Affiliation': 'Division of Liver Transplantation and Hepatobiliary Surgery, Department of Surgery, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, South Korea. drsong71@amc.seoul.kr.'}, {'ForeName': 'Sung-Gyu', 'Initials': 'SG', 'LastName': 'Lee', 'Affiliation': 'Division of Liver Transplantation and Hepatobiliary Surgery, Department of Surgery, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, South Korea.'}, {'ForeName': 'Kyung-Suk', 'Initials': 'KS', 'LastName': 'Suh', 'Affiliation': 'Department of Surgery, College of Medicine, Seoul National University, Seoul, South Korea.'}, {'ForeName': 'Kwang-Woong', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, College of Medicine, Seoul National University, Seoul, South Korea.'}, {'ForeName': 'Nam-Joon', 'Initials': 'NJ', 'LastName': 'Yi', 'Affiliation': 'Department of Surgery, College of Medicine, Seoul National University, Seoul, South Korea.'}, {'ForeName': 'Jae Won', 'Initials': 'JW', 'LastName': 'Joh', 'Affiliation': 'Department of Surgery, Samsung Medical Center, School of Medicine, Sungkyunkwan University, Seoul, South Korea.'}, {'ForeName': 'Choon Hyuck David', 'Initials': 'CHD', 'LastName': 'Kwon', 'Affiliation': 'Department of Surgery and Digestive Disease Institute, Cleveland Clinic, Cleveland Clinic Lerner College of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Jong Man', 'Initials': 'JM', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Samsung Medical Center, School of Medicine, Sungkyunkwan University, Seoul, South Korea.'}, {'ForeName': 'Dong Lak', 'Initials': 'DL', 'LastName': 'Choi', 'Affiliation': 'Department of Surgery, College of Medicine, Catholic University of Daegu, Daegu, South Korea.'}, {'ForeName': 'Joo Dong', 'Initials': 'JD', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, College of Medicine, Catholic University of Daegu, Daegu, South Korea.'}, {'ForeName': 'Myoung Soo', 'Initials': 'MS', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, College of Medicine, Yonsei University, Seoul, South Korea.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-019-04241-w'] 82,31637444,Intrathecal liposomal cytarabine plus systemic therapy versus systemic chemotherapy alone for newly diagnosed leptomeningeal metastasis from breast cancer.,"BACKGROUND DEPOSEIN (NCT01645839) was a randomized open-label phase III study to explore the role of intrathecal chemotherapy in patients with newly diagnosed leptomeningeal metastasis (LM), a common manifestation of breast cancer. METHODS Patients with newly diagnosed LM defined by tumor cells in the cerebrospinal fluid or combination of clinical and neuroimaging signs of LM were randomized to receive systemic therapy alone (control group) or systemic therapy plus intrathecal liposomal cytarabine (experimental group). Progression-free survival related to LM (LM-PFS) was the primary endpoint. RESULTS Thirty-seven and 36 patients were assigned to the control and the experimental groups. Median number of liposomal cytarabine injections in the experimental group was 5 (range 1-20). Focal radiotherapy was performed in 6 (16%) and 3 (8%) patients in the control and experimental groups. In the intent-to-treat population, median LM-PFS was 2.2 months (95% CI: 1.3-3.1) in the control versus 3.8 months (95% CI: 2.3-6.8) in the experimental group (hazard ratio 0.61, 95% CI: 0.38-0.98) (P = 0.04). Seventy-one patients have died. Median overall survival was 4.0 months (95% CI: 2.2-6.3) in the control versus 7.3 months (95% CI: 3.9-9.6) in the experimental group (hazard ratio 0.85, 95% CI: 0.53-1.36) (P = 0.51). Serious adverse events were reported in 22 and 30 patients, respectively. Quality of life until progression did not differ between groups. CONCLUSION The addition of intrathecal liposomal cytarabine to systemic treatment improves LM-related PFS. Confirmatory trials with optimized patient selection criteria and more active drugs may be required to demonstrate a survival benefit from intrathecal pharmacotherapy.",2020,"Quality of life until progression did not differ between groups. ","['Thirty-seven and 36 patients', 'Patients with newly diagnosed LM defined by tumor cells in the cerebrospinal fluid or combination of clinical and neuroimaging signs of LM', 'newly diagnosed leptomeningeal metastasis from breast cancer', 'patients with newly diagnosed leptomeningeal metastasis (LM']","['intrathecal chemotherapy', 'systemic therapy alone (control group) or systemic therapy plus intrathecal liposomal cytarabine', 'Focal radiotherapy', 'Intrathecal liposomal cytarabine plus systemic therapy versus systemic chemotherapy alone', 'intrathecal liposomal cytarabine']","['died', 'Progression-free survival', 'LM-related PFS', 'Median number of liposomal cytarabine injections', 'median LM-PFS', 'Median overall survival', 'Quality of life until progression', 'Serious adverse events']","[{'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant (morphologic abnormality)'}, {'cui': 'C0007807'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C4074687', 'cui_str': 'Cytarabine Injection'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0034380'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",71.0,0.23537,"Quality of life until progression did not differ between groups. ","[{'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Le Rhun', 'Affiliation': 'University of Lille, INSERM, Lille, France.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wallet', 'Affiliation': 'Biostatistics Unit, Oscar Lambret Center, Lille, France.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Mailliez', 'Affiliation': 'Neuro-oncology, General and Stereotaxic Neurosurgery service, University Hospital of Lille, Lille, France.'}, {'ForeName': 'Marie Cecile', 'Initials': 'MC', 'LastName': 'Le Deley', 'Affiliation': 'Biostatistics Unit, Oscar Lambret Center, Lille, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Rodrigues', 'Affiliation': 'Neuro-oncology, General and Stereotaxic Neurosurgery service, University Hospital of Lille, Lille, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Boulanger', 'Affiliation': 'Imaging Department, Oscar Lambret Center, Lille, France.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Lorgis', 'Affiliation': 'Department of Medical Oncology, Georges François Leclerc Center, Dijon, France.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Barrière', 'Affiliation': 'Department of Medical Oncology, Antoine Lacassagne Center, Nice, France.'}, {'ForeName': 'Yves Marie', 'Initials': 'YM', 'LastName': 'Robin', 'Affiliation': 'Department of Pathology, Oscar Lambret Center, Lille, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weller', 'Affiliation': 'Department of Neurology & Brain Tumor Center, University Hospital and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Bonneterre', 'Affiliation': 'University of Lille, INSERM, Lille, France.'}]",Neuro-oncology,['10.1093/neuonc/noz201'] 83,31012040,"A Randomized, Placebo-Controlled, Double-Blind Study that Evaluates Efficacy of Intravenous Ibuprofen and Acetaminophen for Postoperative Pain Treatment Following Laparoscopic Cholecystectomy Surgery.","BACKGROUND Ibuprofen is a NSAID that has anti-inflammatory, antipyretic, and analgesic effects. The oral form of the drug has been used safely for a long time and is one of the most preferred NSAIDs. It has been shown that ibuprofen is effective in the treatment of postoperative pain; however, there have not been sufficient studies on ibuprofen. We evaluated and compared the influence of IV forms of ibuprofen and acetaminophen on pain management and opioid consumption on patients undergoing laparoscopic cholecystectomy surgery. METHODS Patients were stratified into three groups. Group I (group ibuprofen, n = 30) was administered 800 mg of IV ibuprofen; group A (group acetaminophen, n = 30) was administered 1000 mg of IV acetaminophen; and group C (control group, n = 30) was given 100 ml of saline solution. We evaluated opioid consumption and VAS scores postoperatively. RESULTS Pain scores in group I and group A at all time periods were lower than those in group C (p < 0.05). Group I had significantly lower VAS scores than those in group A at all time periods postoperatively (p < 0.05). Those in group C had significantly higher opioid consumption than the other groups (p < 0.05). Opioid consumption in group I at all time periods postoperatively was significantly lower than those in group A (p < 0.05). Group I had statistically lower rescue medication than the other groups at all time periods. CONCLUSION Our study suggested that IV ibuprofen resulted in lower pain scores and reduced opioid use compared with acetaminophen postoperatively in the first 24 h in patients undergoing laparoscopic cholecystectomy surgery.",2020,Group I had significantly lower VAS scores than those in group A at all time periods postoperatively (p < 0.05).,"['Patients were stratified into three groups', 'patients undergoing laparoscopic cholecystectomy surgery', 'Laparoscopic Cholecystectomy Surgery']","['ibuprofen and acetaminophen', 'ibuprofen', 'Placebo', 'Opioid consumption', 'Ibuprofen and Acetaminophen', 'ibuprofen, n\u2009=\u200930) was administered 800\xa0mg of IV ibuprofen', 'acetaminophen', 'Ibuprofen', 'acetaminophen, n\u2009=\u200930) was administered 1000\xa0mg of IV acetaminophen; and group C (control group, n\u2009=\u200930) was given 100\xa0ml of saline solution']","['opioid consumption', 'pain management and opioid consumption', 'lower pain scores', 'Pain scores', 'VAS scores', 'rescue medication', 'opioid consumption and VAS scores postoperatively']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0465028,Group I had significantly lower VAS scores than those in group A at all time periods postoperatively (p < 0.05).,"[{'ForeName': 'Mursel', 'Initials': 'M', 'LastName': 'Ekinci', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Medipol University, Bagcilar, 34000, Istanbul, Turkey.'}, {'ForeName': 'Bahadır', 'Initials': 'B', 'LastName': 'Ciftci', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Medipol University, Bagcilar, 34000, Istanbul, Turkey. bciftci@medipol.edu.tr.'}, {'ForeName': 'Erkan Cem', 'Initials': 'EC', 'LastName': 'Celik', 'Affiliation': 'Department of Anesthesiology and Reanimation, Erzurum Regional Training and Research Hospital, Yakutiye, 25070, Erzurum, Turkey.'}, {'ForeName': 'Emine Arzu', 'Initials': 'EA', 'LastName': 'Köse', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Medipol University, Bagcilar, 34000, Istanbul, Turkey.'}, {'ForeName': 'Muhammet Ahmet', 'Initials': 'MA', 'LastName': 'Karakaya', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Medipol University, Bagcilar, 34000, Istanbul, Turkey.'}, {'ForeName': 'Yasar', 'Initials': 'Y', 'LastName': 'Ozdenkaya', 'Affiliation': 'Department of General Surgery, Istanbul Medipol University, Bagcilar, 34000, Istanbul, Turkey.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-019-04220-1'] 84,32286322,"Colloidal Silicon Dioxide in Tablet form (Carbowhite) Efficacy in Patients with Acute Diarrhea: Results of Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study.","The acute diarrhea is a wide-spread disease. The prescription of enterosorbents is appropriate as a primary measure for the treatment of the acute diarrhea for effective prevention of the fluid and electrolyte loss, as well as method for symptom relief of the attack of the disease. Aim of the study - the antidiarrheal efficacy and safety study of high-dispersion silicon dioxide enterosorbent in tablet dosage form in patients with acute diarrhea. This was randomized, double-blind, placebo-controlled, 4-center study. Acute diarrhea was defined as three and more episodes of watery stool per day either during 48 hours or less before study entry in the patients having normal stool recently. It has been postulated that symptoms and signs of acute diarrhea have to be caused by direct infection of the gastrointestinal tract and did not associated with moderate-to-severe systemic states. 144 patients with established acute diarrhea were randomized into treatment group (enterosorbent ""Carbowhite"", n = 120) or placebo group. Date collection including severity diarrhea, systemic symptoms was performed at baseline and daily during 7 days. Stool examination and serological assay were performed at baseline. The primary end points were declared as time to complete recovery from acute diarrhea. It has been found that the use of the siliceous enterosorbent (""Carbowhite"") allowed to reduce (p < 0.001) the treatment period averagely for 0.9 days (95% confidence interval 0.5-1.2 days) in comparison with placebo. Data of safety monitoring has revealed that both patient groups had negative stool culture, while initiation of antibiotic treatment was run more frequently in placebo group (8.3%) compared to investigational product group (4.1%, P = 0.044). The siliceous enterosorbent ""Carbowhite"" was well tolerated and reduced the recovery time of the acute episode of the diarrhea in the clinically significant form.",2020,"The siliceous enterosorbent ""Carbowhite"" was well tolerated and reduced the recovery time of the acute episode of the diarrhea in the clinically significant form.","['144 patients with established acute diarrhea', 'patients with acute diarrhea', 'Patients with Acute Diarrhea']","['treatment group (enterosorbent ""Carbowhite"", n\u2009=\u2009120) or placebo', 'high-dispersion silicon dioxide enterosorbent', 'placebo', 'Colloidal Silicon Dioxide', 'Placebo']","['Stool examination and serological assay', 'Acute diarrhea', 'severity diarrhea, systemic symptoms', 'time to complete recovery from acute diarrhea', 'negative stool culture']","[{'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332624', 'cui_str': 'Dispersion'}, {'cui': 'C0037098', 'cui_str': 'Silicon Dioxide'}, {'cui': 'C0982384', 'cui_str': 'silicon dioxide, colloidal'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205473', 'cui_str': 'Serologic'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0430414', 'cui_str': 'Stool culture'}]",144.0,0.375585,"The siliceous enterosorbent ""Carbowhite"" was well tolerated and reduced the recovery time of the acute episode of the diarrhea in the clinically significant form.","[{'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Tieroshyn', 'Affiliation': 'Kharkiv National Medical University, Kharkiv, Ukraine. v.a.teryshin@gmail.com.'}, {'ForeName': 'Larisa', 'Initials': 'L', 'LastName': 'Moroz', 'Affiliation': 'Vinnytsya National Medical University named after M. I. Pirogov, Vinnytsya, Ukraine.'}, {'ForeName': 'Oleksandra', 'Initials': 'O', 'LastName': 'Prishliak', 'Affiliation': 'Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine.'}, {'ForeName': 'Lyudmila', 'Initials': 'L', 'LastName': 'Shostakovich-Koretska', 'Affiliation': 'Dnipro State Medical Academy, Dnipro, Ukraine.'}, {'ForeName': 'Oksana', 'Initials': 'O', 'LastName': 'Kruglova', 'Affiliation': 'Lugansk State Medical University, Rubizhne, Ukraine.'}, {'ForeName': 'Lyudmila', 'Initials': 'L', 'LastName': 'Gordienko', 'Affiliation': 'Kiev City Clinical Hospital No.9, Kiev, Ukraine.'}]",Scientific reports,['10.1038/s41598-020-62386-0'] 85,31626696,"Evaluation of the abuse potential of pitolisant, a selective H3-receptor antagonist/inverse agonist, for the treatment of adult patients with narcolepsy with or without cataplexy.","OBJECTIVES To evaluate the human abuse potential of pitolisant, a selective histamine 3 (H3)-receptor antagonist/inverse agonist recently approved by the US Food and Drug Administration for the treatment of excessive daytime sleepiness in adult patients with narcolepsy. METHODS Nondependent, recreational stimulant users able to distinguish phentermine HCl 60 mg from placebo in a drug discrimination test were randomized in a four-period, double-blind, crossover design to receive single doses of pitolisant 35.6 mg (therapeutic dose), pitolisant 213.6 mg (supratherapeutic dose), phentermine HCl 60 mg, and placebo. The primary endpoint was maximum effect (Emax) on the 100-point Drug Liking (""at this moment"") visual analog scale. RESULTS In 38 study completers (73.7% male; 65.8% white; mean age, 33.3 years), mean Drug Liking Emax was significantly greater for phentermine versus pitolisant 35.6 mg (mean difference, 21.4; p < 0.0001) and pitolisant 213.6 mg (mean difference, 19.7; p < 0.0001). Drug Liking Emax was similar for pitolisant (both doses) and placebo. Similarly, for key secondary measures of Overall Drug Liking and willingness to Take Drug Again, mean Emax scores were significantly greater for phentermine versus pitolisant (both doses) and similar for pitolisant (both doses) versus placebo. The incidence of adverse events was 82.1% after phentermine HCl 60 mg, 72.5% after pitolisant 213.6 mg, 47.5% after pitolisant 35.6 mg, and 48.8% after placebo administration. CONCLUSIONS In this study, pitolisant demonstrated significantly lower potential for abuse compared with phentermine and an overall profile similar to placebo; this suggests a low risk of abuse for pitolisant. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov NCT03152123. Determination of the abuse potential of pitolisant in healthy, nondependent recreational stimulant users. https://clinicaltrials.gov/ct2/show/NCT03152123.",2020,"The incidence of adverse events was 82.1% after phentermine HCl 60 mg, 72.5% after pitolisant 213.6 mg, 47.5% after pitolisant 35.6 mg, and 48.8% after placebo administration. ","['adult patients with narcolepsy', 'adult patients with narcolepsy with or without cataplexy', 'Nondependent, recreational stimulant users able to distinguish']","['placebo', 'phentermine HCl 60 mg) from placebo', 'phentermine HCl', 'pitolisant 35.6 mg (therapeutic dose), pitolisant 213.6 mg (supratherapeutic dose), phentermine HCl 60 mg, and placebo']","['Drug Liking Emax', 'incidence of adverse events', 'mean Drug Liking Emax', 'Overall Drug Liking and willingness to Take Drug Again, mean Emax scores', 'maximum effect (Emax) on the 100-point Drug Liking (""at this moment"") visual analog scale']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027404', 'cui_str': 'Narcoleptic Syndrome'}, {'cui': 'C0007384', 'cui_str': 'Henneberg Syndrome'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C1299581', 'cui_str': 'Able'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0031447', 'cui_str': 'Phentermine'}, {'cui': 'C0443985', 'cui_str': 'Flinders medical center-7 marker (substance)'}, {'cui': 'C3529928', 'cui_str': 'Pitolisant (substance)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",38.0,0.401013,"The incidence of adverse events was 82.1% after phentermine HCl 60 mg, 72.5% after pitolisant 213.6 mg, 47.5% after pitolisant 35.6 mg, and 48.8% after placebo administration. ","[{'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Setnik', 'Affiliation': 'Syneos Health, Raleigh, NC.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McDonnell', 'Affiliation': 'Syneos Health, Toronto, ON, Canada.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mills', 'Affiliation': 'Syneos Health, Toronto, ON, Canada.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Scart-Grès', 'Affiliation': 'Bioprojet Pharma, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Robert', 'Affiliation': 'Bioprojet Biotech, Saint Grégoire, France.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Dayno', 'Affiliation': 'Harmony Biosciences LLC, Plymouth Meeting, PA.'}, {'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Schwartz', 'Affiliation': 'Bioprojet Pharma, Paris, France.'}]",Sleep,['10.1093/sleep/zsz252'] 86,32297875,"An Internet-Based, Peer-Delivered Messaging Intervention for HIV Testing and Condom Use Among Men Who Have Sex With Men in India (CHALO!): Pilot Randomized Comparative Trial.","BACKGROUND Leveraging internet-based communication tools (eg, messaging apps, SMS text messaging, and email) may be an effective avenue for delivery of HIV prevention messages to men who have sex with men (MSM) in India, but there are limited models for such internet-based interventions. OBJECTIVE The CHALO! pilot was an online educational and behavioral intervention aimed to determine the feasibility, acceptability, and preliminary impact of a peer-delivered, internet-based messaging intervention for HIV testing and consistent condom use for MSM in India. The messages addressed barriers to HIV testing and condom use and were theoretically based on the information-motivation-behavioral skills model. METHODS Between February and March 2015, we recruited, enrolled, and randomized 244 participants via online advertisements on mobile dating apps and Facebook. Eligible men (18 years or older, sexually active with other men, and self-reported HIV-negative or unknown status) were randomized to receive educational and motivational messages framed as either approach (ie, a desirable outcome to be achieved) or avoidance (an undesirable outcome to be avoided) over 12 weeks via internet-based messaging platforms. Participants completed online surveys at baseline and immediately postintervention. RESULTS Participants were similar across arms with respect to sociodemographic and behavioral characteristics. Over 82.0% (200/244) of participants were retained (ie, viewed final messages), and 52.3% (130/244) of them completed the follow-up survey. Of those completing the follow-up survey, 82.3% (107/130) liked or strongly liked participating in CHALO!. The results showed a significant increase in self-reported HIV testing in the past 6 months from baseline to follow-up (41/130, 31.5% to 57/130, 43.8%; P=.04). When including those who reported intentions to test, this percentage increased from 44.6% (58/130) at baseline to 65.4% (85/130) at follow-up (P<.01). When examining intentions to test among those without prior HIV testing, intentions increased from 32% (16/50) of the sample at baseline to 56% (28/50) of the sample at follow-up (P=.02). Condom use during anal sex did not significantly change from baseline to follow-up. HIV testing and condom use did not significantly differ between approach and avoidance conditions at follow-up. CONCLUSIONS As one of the first studies of an online HIV prevention intervention for Indian MSM, CHALO! was feasible to implement by a community-based organization, was acceptable to participants, and demonstrated potential to improve HIV testing rates.",2020,"The results showed a significant increase in self-reported HIV testing in the past 6 months from baseline to follow-up (41/130, 31.5% to 57/130, 43.8%; P=.04).","['Men', 'Eligible men (18 years or older, sexually active with other men, and self-reported HIV-negative or unknown status', 'Who Have Sex With Men in India', 'Between February and March 2015, we recruited, enrolled, and randomized 244 participants via online advertisements on mobile dating apps and Facebook', 'men who have sex with men (MSM) in India']","['CHALO', 'Peer-Delivered Messaging Intervention for HIV Testing and Condom Use', 'educational and motivational messages framed as either approach (ie, a desirable outcome to be achieved) or avoidance', 'peer-delivered, internet-based messaging intervention for HIV testing and consistent condom use for MSM']",['self-reported HIV testing'],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0241028', 'cui_str': 'Sexually active'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}]",244.0,0.165018,"The results showed a significant increase in self-reported HIV testing in the past 6 months from baseline to follow-up (41/130, 31.5% to 57/130, 43.8%; P=.04).","[{'ForeName': 'Viraj V', 'Initials': 'VV', 'LastName': 'Patel', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Albert Einstein College of Medicine, Montefiore Health System, Bronx, NY, United States.'}, {'ForeName': 'Shruta', 'Initials': 'S', 'LastName': 'Rawat', 'Affiliation': 'The Humsafar Trust, Mumbai, India.'}, {'ForeName': 'Alpana', 'Initials': 'A', 'LastName': 'Dange', 'Affiliation': 'The Humsafar Trust, Mumbai, India.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Lelutiu-Weinberger', 'Affiliation': 'François-Xavier Bagnoud Center, School of Nursing, Rutgers Biomedical and Health Sciences, Newark, NJ, United States.'}, {'ForeName': 'Sarit A', 'Initials': 'SA', 'LastName': 'Golub', 'Affiliation': 'Department of Psychology, Hunter College, City University of New York, New York, NY, United States.'}]",JMIR public health and surveillance,['10.2196/16494'] 87,31735487,"Effects of Cognitive Rehabilitation on Cognition, Apathy, Quality of Life, and Subjective Complaints in the Elderly: A Randomized Controlled Trial.","OBJECTIVE To determine the efficacy of a new-generation integrative cognitive rehabilitation (CR) program (Rehacop) on cognition, clinical symptoms, quality of life (QoL), and subjective complaints in the elderly. DESIGN A randomized controlled trial study with a cohort of elderly people over 55 years of age. SETTING Communities of the Basque Country (Spain). PARTICIPANTS A total of 124 elderly participants (aged 79.00 ± 8.85 years) were randomized in the Rehacop group (RG) (n = 62) and control group (CG) (n = 62). INTERVENTION The RG attended 39 CR sessions for 3 months (3 sessions/week, 60-minute/session) with the Rehacop program. The CG performed occupational tasks with the same frequency and duration as the RG. METHODS Participants underwent a neuropsychological assessment at baseline and post-treatment which included cognitive, clinical, and functional tests. In addition, participants and their formal caregivers completed a subjective complaints questionnaire. The data were analyzed according to the intention to treat analysis and with participants who completed the study. This study was registered at clinicaltrials.gov (NCT03435029). RESULTS The RG showed significant improvements compared to the CG in neurocognition (ANCOVA timexgroup interaction effect size (η p 2 )=0.05, 90% confidence interval (CI) = 0.00-0.12). The RG also reduced apathy (η p 2 =0.06, 90% CI = 0.01-0.15) and participants' subjective complaints (η p 2 =0.11, 90% CI = 0.03-0.21) and improved QoL (η p 2 =0.08, 90% CI = 0.01-0.17). CONCLUSIONS Participants who attended the intervention improved their cognition, QoL, and reduced apathy and subjective complaints after treatment. These findings provide a new understanding of the benefits of CR in the elderly.",2020,"The RG showed significant improvements compared to the CG in neurocognition (ANCOVA timexgroup interaction effect size (η p 2 )=0.05, 90% confidence interval (CI) = 0.00-0.12).","['Elderly', 'A total of 124 elderly participants (aged 79.00\xa0±\xa08.85 years', 'elderly people over 55 years of age', 'Participants underwent a neuropsychological assessment at baseline and post-treatment which included cognitive, clinical, and functional tests', 'Communities of the Basque Country (Spain']","['Rehacop group (RG) (n\u202f=\u202f62) and control group (CG', 'new-generation integrative cognitive rehabilitation (CR) program (Rehacop', 'Cognitive Rehabilitation']","['CG in neurocognition (ANCOVA timexgroup interaction effect size', 'QoL', 'cognition, QoL, and reduced apathy and subjective complaints', 'cognition, clinical symptoms, quality of life (QoL), and subjective complaints', 'Cognition, Apathy, Quality of Life, and Subjective Complaints', 'subjective complaints questionnaire', 'subjective complaints']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0337796', 'cui_str': 'Basques (ethnic group)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0085632', 'cui_str': 'Apathy'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",124.0,0.0448712,"The RG showed significant improvements compared to the CG in neurocognition (ANCOVA timexgroup interaction effect size (η p 2 )=0.05, 90% confidence interval (CI) = 0.00-0.12).","[{'ForeName': 'Genoveva', 'Initials': 'G', 'LastName': 'Montoya-Murillo', 'Affiliation': 'Department of Methods and Experimental Psychology, Faculty of Psychology and Education, University of Deusto, Bilbao, Spain.'}, {'ForeName': 'Naroa', 'Initials': 'N', 'LastName': 'Ibarretxe-Bilbao', 'Affiliation': 'Department of Methods and Experimental Psychology, Faculty of Psychology and Education, University of Deusto, Bilbao, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Peña', 'Affiliation': 'Department of Methods and Experimental Psychology, Faculty of Psychology and Education, University of Deusto, Bilbao, Spain.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Ojeda', 'Affiliation': 'Department of Methods and Experimental Psychology, Faculty of Psychology and Education, University of Deusto, Bilbao, Spain. Electronic address: nojeda@deusto.es.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2019.10.011'] 88,32022679,Effect of cloud-based sleep coaches on positive airway pressure adherence.,"STUDY OBJECTIVES Decreased early positive airway pressure (PAP) adherence is predictive of poor long-term adherence. We hypothesized that cloud-based sleep coaches (CBSC) providing protocol-driven live telephone contact with patients starting treatment would improve early adherence. METHODS At PAP set-up patients were randomized to: (1) standard care (SC) including respiratory therapist PAP setup, wireless adherence monitoring, and elective use of a mobile adherence feedback application (PAPapp); or (2) SC+CBSC. Primary 3-month endpoints were adherence (all nights, nights used, % of nights ≥ 4 hours use, and % participants with ≥ 4 hours use on ≥ 70% of nights [% ≥ 4 ≥ 70%]) and secondary endpoints were change in Epworth sleepiness scale (ESS) and satisfaction with treatment and PAPapp use. RESULTS Two hundred fifty participants were randomized (SC 126, SC+CBSC 124). Characteristics SC versus SC+CBSC (mean ± SD) for age (55.2 ± 13.4 versus 54.9 ± 11.5 years), diagnostic apnea-hypopnea index (36.7 ± 21.1 versus 36.6 ± 20.6 events/h), and ESS (10.8 ± 6.1 versus 11.2 ± 6.0) did not differ. At 3 months, the % of days with ≥ 4 hours of PAP use (SC: 48.1 ± 36.8% versus SC+CBSC: 57.9 ± 35.4%, P = 0.032), use all nights (SC:3.7 ± 2.7 hours versus SC + CBSC: 4.4 ± 2.6 hours, P=0.027), and PAPapp use satisfaction were greater with SC+CBSC (intention to treat analysis). The [% ≥ 4 ≥ 70%] did not differ between groups in the intention to treat analysis but was higher in those completing CBSC interventions. The ESS improvement and patient satisfaction did not differ between groups. CONCLUSIONS The CBSC system improved PAP adherence at 3 months. CLINICAL TRIAL REGISTRATION Registry: ClinicalTrials.gov; Title: ThErapy Adherence Management in Veterans; Identifier: NCT03243487; URL: https://clinicaltrials.gov/ct2/show/NCT03243487.",2020,The [% ≥4≥70%] did not differ between groups (intention to treat) only higher in those completing CBSC interventions.,['250 participants'],"['Cloud-Based Sleep Coaches', 'cloud-based sleep coaches (CBSC) providing protocol-driven live telephone contact', 'standard care (SC) including respiratory therapist PAP setup, wireless adherence monitoring, and elective use of a mobile adherence feedback application (PAPapp); or (2) SC+CBSC']","['Positive Airway Pressure Adherence', 'PAP adherence', 'Epworth sleepiness scale (ESS) and satisfaction with treatment and PAPapp use', 'positive airway pressure (PAP) adherence', 'adherence (all nights, nights used,% of nights ≥ 4 hours use', 'ESS improvement and patient satisfaction']","[{'cui': 'C2348831', 'cui_str': '250'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1709924', 'cui_str': 'Respiratory therapist'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C3541276', 'cui_str': 'ESS - Epworth Sleepiness Scale'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1292426', 'cui_str': '4 hours (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]",250.0,0.136219,The [% ≥4≥70%] did not differ between groups (intention to treat) only higher in those completing CBSC interventions.,"[{'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Berry', 'Affiliation': 'Malcom Randall Veterans Affairs Medical Center, Gainesville, Florida.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Beck', 'Affiliation': 'Malcom Randall Veterans Affairs Medical Center, Gainesville, Florida.'}, {'ForeName': 'Jeffrey G', 'Initials': 'JG', 'LastName': 'Jasko', 'Affiliation': 'Philips Respironics, Murrysville, Pennsylvania.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8276'] 89,32298407,Improving Lifestyle Behaviors After Breast Cancer Treatment Among African American Women With and Without Diabetes: Role of Health Care Professionals.,"BACKGROUND Little is known about the effect of health professionals' advice on promoting healthy lifestyle behaviors (diet and exercise) among breast cancer patients. PURPOSE To identify predictors of receiving lifestyle advice from health professionals and its impact on healthy lifestyle behaviors. METHODS We used data from a randomized controlled trial of an interactive, cancer-communication video program using African American breast cancer survivor stories for newly diagnosed African American breast cancer patients (Stages 0-III). Participants completed five interviews over 2 years. This intervention did not significantly affect changes in quality-of-life outcomes. In secondary analysis, we examined differences in baseline variables between women with and without diabetes. Logistic regression models identified independent predictors of receiving advice from ""a doctor or other health professional"" to improve diet and exercise and of self-reported change in diet and exercise habits at 2 year follow-up. RESULTS Of 193 patients included (85% of 228 enrolled), 53 (28%) had diabetes. At 2 year follow-up, a greater proportion of women with (vs. without) diabetes reported receiving advice by a doctor/health professional to improve their diet (73% vs. 57%, p = .04,). Predictors of receiving dietary advice were obesity, diabetes, and breast-conserving surgery (each p < .05). Women receiving dietary advice were 2.75 times more likely to report improving their diet (95% confidence interval: 1.17, 6.46) at follow-up, but receiving physical activity advice was not significantly associated with patients reporting an increase in exercise. CONCLUSIONS Although receiving dietary advice predicted dietary improvements, receiving exercise advice did not lead to an increase in physical activity. CLINICAL TRIAL REGISTRATION Trial Number NCT00929084.",2021,"Logistic regression models identified independent predictors of receiving advice from ""a doctor or other health professional"" to improve diet and exercise and of self-reported change in diet and exercise habits at 2 year follow-up. ","['Of 193 patients included (85% of 228 enrolled), 53 (28%) had diabetes', 'newly diagnosed African American breast cancer patients (Stages 0-III', 'African American Women', 'women with and without diabetes', 'breast cancer patients']","['interactive, cancer-communication video program', 'African American breast cancer survivor stories']","['physical activity', 'quality-of-life outcomes', 'obesity, diabetes, and breast-conserving surgery', 'physical activity advice', 'Lifestyle Behaviors', 'exercise']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0441763', 'cui_str': 'Stage 0'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",228.0,0.0709718,"Logistic regression models identified independent predictors of receiving advice from ""a doctor or other health professional"" to improve diet and exercise and of self-reported change in diet and exercise habits at 2 year follow-up. ","[{'ForeName': 'Soghra', 'Initials': 'S', 'LastName': 'Jarvandi', 'Affiliation': 'Department of Family and Consumer Sciences, University of Tennessee, Knoxville, TN, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pérez', 'Affiliation': 'Department of Medicine, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Margenthaler', 'Affiliation': 'Department of Surgery, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Graham A', 'Initials': 'GA', 'LastName': 'Colditz', 'Affiliation': 'Department of Surgery, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Kreuter', 'Affiliation': 'Brown School of Social Work, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Donna B', 'Initials': 'DB', 'LastName': 'Jeffe', 'Affiliation': 'Department of Medicine, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa020'] 90,32083443,"Comparison of the effect of 12- and 24-session cardiac rehabilitation on physical, psychosocial and biomedical factors in ischemic heart disease patients.","Background Cardiac rehabilitation (CR) is a key component of effective care for patients with a wide spectrum of cardiac problems. It seems that the short-term provision of these services can facilitate their use and meeting of related needs for patients participating in the CR programs. Materials and methods In this interventional study on patients with ischemic heart disease (IHD) referred to the Cardiac Rehabilitation Center of Chamran Hospital, Isfahan, Iran. One-hundred and twelve patients were randomly divided into two groups of 12 and 24 sessions of CR [mean age: 59.2 ± (9.02) and 60.7 ± (9.3) years, respectively] and underwent a CR program. All information was collected in two stages, before the beginning of the program and after completion of 12- and 24-session rehabilitation programs. The data collection tools were demographics questionnaire, the International Physical Activity Questionnaires (IPAQ), McNew Quality of Life Questionnaire, Beck Depression Inventory (BDI), and Zung Self-Rating Anxiety Scale (SAS). Results The results of this study showed that in both groups, total physical activity (PA) and functional capacity increased, and the quality of life (QOL) was statistically improved. Comparison of changes in mean differences at the end of the rehabilitation periods between the two groups, showed that only the weight, body mass index (BMI), waist circumference (WC) and high-density lipoprotein (HDL) in the 24-session group significantly decreased compared to the 12-session group and, but no significant difference in other variables was observed. Conclusion Overall, the findings of this study support the overall benefits of the CR program in both the short and the long term. Therefore it can be suggested that a short-term program can still be a valuable option for reducing the risk in cardiac patients and meeting their service needs.",2020,"Comparison of changes in mean differences at the end of the rehabilitation periods between the two groups, showed that only the weight, body mass index (BMI), waist circumference (WC) and high-density lipoprotein (HDL) in the 24-session group significantly decreased compared to the 12-session group and, but no significant difference in other variables was observed.","['One-hundred and twelve patients', 'patients with a wide spectrum of cardiac problems', 'patients with ischemic heart disease (IHD) referred to the Cardiac Rehabilitation Center of Chamran Hospital, Isfahan, Iran', 'ischemic heart disease patients', 'patients participating in the CR programs']","['12- and 24-week cardiac rehabilitation', ' Cardiac rehabilitation (CR']","['demographics questionnaire, the International Physical Activity Questionnaires (IPAQ), McNew Quality of Life Questionnaire, Beck Depression Inventory (BDI), and Zung Self-Rating Anxiety Scale (SAS', 'total physical activity (PA) and functional capacity', 'weight, body mass index (BMI), waist circumference (WC) and high-density lipoprotein (HDL', 'quality of life (QOL)(SF36']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034380'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}]",112.0,0.0192077,"Comparison of changes in mean differences at the end of the rehabilitation periods between the two groups, showed that only the weight, body mass index (BMI), waist circumference (WC) and high-density lipoprotein (HDL) in the 24-session group significantly decreased compared to the 12-session group and, but no significant difference in other variables was observed.","[{'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Sadeghi', 'Affiliation': 'Cardiac Rehabilitation Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Izadi', 'Affiliation': 'Heart Failure Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Mahdi Hadavi', 'Affiliation': 'Interventional Cardiology Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Rafati Fard', 'Affiliation': 'Cardiac Rehabilitation Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Roohafza', 'Affiliation': 'Isfahan Cardiovascular Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran, Phone: 0098 31 36115237, email:hroohafza@gmail.com.'}]",Hormone molecular biology and clinical investigation,['10.1515/hmbci-2019-0023'] 91,32303801,Additional periarticular catheter shows no superiority over single-shot local infiltration analgesia alone in unicondylar knee replacement.,"PURPOSE Local infiltration analgesia (LIA) has attracted growing interest in recent years. To prolong the positive effects of LIA, a continuous intraarticular perfusion has been introduced in total knee arthroplasty with good clinical results. The purpose of the present study was to evaluate if similar results can be obtained with the use of a continuous periarticular perfusion in unicondylar knee arthroplasty (UKA). METHODS 50 consecutively selected patients undergoing UKA received either a single-shot LIA (control group; n = 25) or single-shot LIA combined with a continuous postoperative periarticular perfusion for 2 postoperative days (intervention group, n = 25). VAS (visual analogue scale) for pain, pain medication consumption and range of flexion were recorded postoperatively for 6 days. The catheter was removed after 2 days. RESULTS Only minor advantages of using a continuous periarticular catheter could be shown. Patients in the intervention group showed significant lower VAS scores on day 1 and required significant less pain medication on day 6. Further, there was a significant difference in the range of flexion on day 3, on which patients of the intervention group were able to bend the knee joint on average by 12° more than patients of the control group. On the other days, any significant differences between the two groups were not observed. CONCLUSION In summary, the present study could not identify any superiority of a periarticular catheter over single-shot LIA in UKA. Because of additional costs and the potential risk of infection, the conclusion of this study is to not recommend adding a periarticular catheter to the single-shot LIA in UKA. LEVEL OF EVIDENCE II.",2021,"Further, there was a significant difference in the range of flexion on day 3, on which patients of the intervention group were able to bend the knee joint on average by 12° more than patients of the control group.","['unicondylar knee arthroplasty (UKA', '50 consecutively selected patients undergoing UKA received either a', 'unicondylar knee replacement']","['Local infiltration analgesia (LIA', 'single-shot LIA (control group; n\u2009=\u200925) or single-shot LIA combined with a continuous postoperative periarticular perfusion', 'LIA']","['VAS scores', 'range of flexion', 'VAS (visual analogue scale) for pain, pain medication consumption and range of flexion', 'pain medication']","[{'cui': 'C0864243', 'cui_str': 'Unicompartmental Knee Arthroplasty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0595695', 'cui_str': 'Periarticular route'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",50.0,0.0410499,"Further, there was a significant difference in the range of flexion on day 3, on which patients of the intervention group were able to bend the knee joint on average by 12° more than patients of the control group.","[{'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Meier', 'Affiliation': 'Sportklinik Stuttgart, Taubenheimstraße 8, 70372, Stuttgart, Germany. malin.meier@icloud.com.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Burkhardt', 'Affiliation': 'Sportklinik Stuttgart, Taubenheimstraße 8, 70372, Stuttgart, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Huth', 'Affiliation': 'Sportklinik Stuttgart, Taubenheimstraße 8, 70372, Stuttgart, Germany.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Best', 'Affiliation': 'Sportklinik Stuttgart, Taubenheimstraße 8, 70372, Stuttgart, Germany.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Thienpont', 'Affiliation': 'Cliniques Universitaires Saint-Luc, Bruxelles, Belgium.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Beckmann', 'Affiliation': 'Sportklinik Stuttgart, Taubenheimstraße 8, 70372, Stuttgart, Germany.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-020-05981-y'] 92,30944054,The effect of smartphone-based monitoring on illness activity in bipolar disorder: the MONARCA II randomized controlled single-blinded trial.,"BACKGROUND Recently, the MONARCA I randomized controlled trial (RCT) was the first to investigate the effect of smartphone-based monitoring in bipolar disorder (BD). Findings suggested that smartphone-based monitoring sustained depressive but reduced manic symptoms. The present RCT investigated the effect of a new smartphone-based system on the severity of depressive and manic symptoms in BD. METHODS Randomized controlled single-blind parallel-group trial. Patients with BD, previously treated at The Copenhagen Clinic for Affective Disorder, Denmark and currently treated at community psychiatric centres, private psychiatrists or GPs were randomized to the use of a smartphone-based system or to standard treatment for 9 months. Primary outcomes: differences in depressive and manic symptoms between the groups. RESULTS A total of 129 patients with BD (ICD-10) were included. Intention-to-treat analyses showed no statistically significant effect of smartphone-based monitoring on depressive (B = 0.61, 95% CI -0.77 to 2.00, p = 0.38) and manic (B = -0.25, 95% CI -1.1 to 0.59, p = 0.56) symptoms. The intervention group reported higher quality of life and lower perceived stress compared with the control group. In sub-analyses, the intervention group had higher risk of depressive episodes, but lower risk of manic episodes compared with the control group. CONCLUSIONS There was no effect of smartphone-based monitoring. In patient-reported outcomes, patients in the intervention group reported improved quality of life and reduced perceived stress. Patients in the intervention group had higher risk of depressive episodes and reduced risk of manic episodes. Despite the widespread use and excitement of electronic monitoring, few studies have investigated possible effects. Further studies are needed.",2020,The intervention group reported higher quality of life and lower perceived stress compared with the control group.,"['129 patients with BD (ICD-10', 'Patients with BD, previously treated at The Copenhagen Clinic for Affective Disorder, Denmark and currently treated at community psychiatric centres, private psychiatrists or GPs', 'bipolar disorder', 'bipolar disorder (BD']","['smartphone-based system or to standard treatment', 'smartphone-based monitoring']","['smartphone-based monitoring on depressive', 'higher risk of depressive episodes and reduced risk of manic episodes', 'higher quality of life and lower perceived stress', 'depressive and manic symptoms', 'quality of life and reduced perceived stress', 'risk of manic episodes', 'higher risk of depressive episodes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0525045', 'cui_str': 'Affective Disorders'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0033872', 'cui_str': 'Psychiatrist'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0349208', 'cui_str': 'Manic episode'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0338831', 'cui_str': 'Manic State'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",129.0,0.202873,The intervention group reported higher quality of life and lower perceived stress compared with the control group.,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Faurholt-Jepsen', 'Affiliation': 'Copenhagen Affective Disorder Research Center (CADIC), Psychiatric Center Copenhagen, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Frost', 'Affiliation': 'IT University of Copenhagen, Rued Langgaards Vej 7, 2300 Copenhagen, Denmark.'}, {'ForeName': 'Ellen Margrethe', 'Initials': 'EM', 'LastName': 'Christensen', 'Affiliation': 'Copenhagen Affective Disorder Research Center (CADIC), Psychiatric Center Copenhagen, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Jakob E', 'Initials': 'JE', 'LastName': 'Bardram', 'Affiliation': 'Department of Applied Mathematics and Computer Science, Technical University of Denmark, Lyngby, Denmark.'}, {'ForeName': 'Maj', 'Initials': 'M', 'LastName': 'Vinberg', 'Affiliation': 'Copenhagen Affective Disorder Research Center (CADIC), Psychiatric Center Copenhagen, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lars Vedel', 'Initials': 'LV', 'LastName': 'Kessing', 'Affiliation': 'Copenhagen Affective Disorder Research Center (CADIC), Psychiatric Center Copenhagen, Rigshospitalet, Copenhagen, Denmark.'}]",Psychological medicine,['10.1017/S0033291719000710'] 93,30973115,'Tell Your Story': a randomized controlled trial of an online intervention to reduce mental health stigma and increase help-seeking in refugee men with posttraumatic stress.,"BACKGROUND Refugees report elevated rates of posttraumatic stress disorder (PTSD), but are relatively unlikely to seek help for their symptoms. Mental health stigma is a key barrier to help-seeking amongst refugees. We evaluated the efficacy of an online intervention in reducing self-stigma and increasing help-seeking in refugee men. METHODS Participants were 103 refugee men with PTSD symptoms from Arabic, Farsi or Tamil-speaking backgrounds who were randomly assigned to either receive an 11-module online stigma reduction intervention specifically designed for refugees ('Tell Your Story', TYS) or to a wait-list control (WLC) group. Participants completed online assessments of self-stigma for PTSD and help-seeking, and help-seeking intentions and behaviors at baseline, post-intervention, and at a 1 month follow-up. RESULTS Intent-to-treat analyses indicated that, compared to the WLC, TYS resulted in significantly smaller increases in self-stigma for seeking help from post-treatment to follow-up (d = 0.42, p = 0.008). Further, participants in the TYS conditions showed greater help-seeking behavior from new sources at follow-up (B = 0.69, 95% CI 0.19-1.18, p = 0.007) than those in the WLC. The WLC showed significantly greater increases in help-seeking intentions from post-intervention to follow-up (d = 0.27, p = 0.027), relative to the TYS group. CONCLUSIONS This is the first investigation of a mental health stigma reduction program specifically designed for refugees. Findings suggest that evidence-based stigma reduction strategies are beneficial in targeting self-stigma related to help-seeking and increasing help-seeking amongst refugees. These results indicate that online interventions focusing on social contact may be a promising avenue for removing barriers to accessing help for mental health symptoms in traumatized refugees.",2020,Findings suggest that evidence-based stigma reduction strategies are beneficial in targeting self-stigma related to help-seeking and increasing help-seeking amongst refugees.,"['refugee men', 'refugee men with posttraumatic stress', 'Participants were 103 refugee men with PTSD symptoms from Arabic, Farsi or Tamil-speaking backgrounds']","['11-module online stigma reduction intervention specifically designed for refugees', 'online intervention']","['help-seeking intentions', 'self-stigma', 'help-seeking behavior', 'mental health stigma']","[{'cui': 'C0034961', 'cui_str': 'Refugees'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C2745478', 'cui_str': 'AM 103'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0337946', 'cui_str': 'Tamils (ethnic group)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}]","[{'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0683301', 'cui_str': 'Help-Seeking Behavior'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",103.0,0.0208517,Findings suggest that evidence-based stigma reduction strategies are beneficial in targeting self-stigma related to help-seeking and increasing help-seeking amongst refugees.,"[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Nickerson', 'Affiliation': 'School of Psychology, University of New South Wales, SydneyNSW2052, Australia.'}, {'ForeName': 'Yulisha', 'Initials': 'Y', 'LastName': 'Byrow', 'Affiliation': 'School of Psychology, University of New South Wales, SydneyNSW2052, Australia.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Pajak', 'Affiliation': 'School of Psychology, University of New South Wales, SydneyNSW2052, Australia.'}, {'ForeName': 'Tadgh', 'Initials': 'T', 'LastName': 'McMahon', 'Affiliation': 'Settlement Services International, Sydney, NSWAustralia.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Bryant', 'Affiliation': 'School of Psychology, University of New South Wales, SydneyNSW2052, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Christensen', 'Affiliation': 'Black Dog Institute, School of Psychiatry, University of New South Wales, SydneyNSW2052, Australia.'}, {'ForeName': 'Belinda J', 'Initials': 'BJ', 'LastName': 'Liddell', 'Affiliation': 'School of Psychology, University of New South Wales, SydneyNSW2052, Australia.'}]",Psychological medicine,['10.1017/S0033291719000606'] 94,25135587,Ivabradine Versus Beta-Blockers in Patients with Conduction Abnormalities or Left Ventricular Dysfunction Undergoing Cardiac Surgery.,"INTRODUCTION In patients with conduction abnormalities or left ventricle (LV) dysfunction the use of β-blockers for post cardiac surgery rhythm control is difficult and controversial, with a paucity of information about other drugs such ivabradine used postoperatively. The objective of this study was to compare the efficacy and safety of ivabradine versus metoprolol used perioperatively in cardiac surgery patients with conduction abnormalities or LV systolic dysfunction. METHODS This was an open-label, randomized clinical trial enrolling 527 patients with conduction abnormalities or LV systolic dysfunction undergoing coronary artery bypass grafting or valvular replacement, randomized to take ivabradine or metoprolol, or metoprolol plus ivabradine. The primary endpoints were the composites of 30-day mortality, in-hospital atrial fibrillation (AF), in-hospital three-degree atrioventricular block and need for pacing, in-hospital worsening heart failure (HF; safety endpoints), duration of hospital stay and immobilization and the above endpoint plus in-hospital bradycardia, gastrointestinal symptoms, sleep disturbances, cold extremities (efficacy plus safety endpoint). RESULTS Heart rate reduction and prevention of postoperative AF or tachyarrhythmia with combined therapy was more effective than with metoprolol or ivabradine alone during the immediate postoperative management of cardiac surgery patients. In the Ivabradine group, the frequency of early postoperative pacing and HF worsening was smaller than in the Metoprolol group and in combined therapy group. The frequency of primary combined endpoint was lower in the combined Ivabradine + Metoprolol group compared with the monotherapy groups. CONCLUSION Considering efficacy and safety, the cardiac rhythm reduction after open heart surgery in patients with conduction abnormalities or LV dysfunction with ivabradine plus metoprolol emerged as the best treatment in this trial.",2014,"RESULTS Heart rate reduction and prevention of postoperative AF or tachyarrhythmia with combined therapy was more effective than with metoprolol or ivabradine alone during the immediate postoperative management of cardiac surgery patients.","['patients with conduction abnormalities or left ventricle (LV) dysfunction', 'cardiac surgery patients', 'patients with conduction abnormalities or LV dysfunction with', 'Patients with Conduction Abnormalities or Left Ventricular Dysfunction Undergoing Cardiac Surgery', 'cardiac surgery patients with conduction abnormalities or LV systolic dysfunction', '527 patients with conduction abnormalities or LV systolic dysfunction undergoing coronary artery bypass grafting or valvular replacement, randomized to take']","['ivabradine or metoprolol, or metoprolol plus ivabradine', 'ivabradine plus metoprolol', 'ivabradine', 'Ivabradine', 'metoprolol', 'Ivabradine Versus Beta-Blockers', 'Metoprolol']","['efficacy and safety', 'composites of 30-day mortality, in-hospital atrial fibrillation (AF), in-hospital three-degree atrioventricular block and need for pacing, in-hospital worsening heart failure (HF; safety endpoints), duration of hospital stay and immobilization and the above endpoint plus in-hospital bradycardia, gastrointestinal symptoms, sleep disturbances, cold extremities (efficacy plus safety endpoint', 'frequency of early postoperative pacing and HF worsening']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457405', 'cui_str': 'Conduction (qualifier value)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0018827', 'cui_str': 'Heart Ventricle'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0242698', 'cui_str': 'Ventricular Dysfunction, Left'}, {'cui': 'C0749225', 'cui_str': 'Systolic dysfunction'}, {'cui': 'C4517805', 'cui_str': 'Five hundred and twenty-seven'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0257190', 'cui_str': 'ivabradine'}, {'cui': 'C0025859', 'cui_str': 'Metoprolol'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0004245', 'cui_str': 'Atrioventricular Conduction Block'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0020944', 'cui_str': 'Immobilization'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0277925', 'cui_str': 'Cold extremities (finding)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",527.0,0.0460629,"RESULTS Heart rate reduction and prevention of postoperative AF or tachyarrhythmia with combined therapy was more effective than with metoprolol or ivabradine alone during the immediate postoperative management of cardiac surgery patients.","[{'ForeName': 'Luminita', 'Initials': 'L', 'LastName': 'Iliuta', 'Affiliation': '""Carol Davila"" University of Medicine and Pharmacy, Bucharest, Romania.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Rac-Albu', 'Affiliation': '""Carol Davila"" University of Medicine and Pharmacy, Bucharest, Romania. racalbu@yahoo.com.'}]",Cardiology and therapy,['10.1007/s40119-013-0024-1'] 95,32193269,Implementing a hybrid cognitive-behavioural therapy for pain-related insomnia in primary care: lessons learnt from a mixed-methods feasibility study.,"OBJECTIVES To test the feasibility of implementing a brief but intensive hybrid cognitive behavioural therapy (Hybrid CBT) for pain-related insomnia. DESIGN Mixed-methods, with qualitative process evaluation on a two-arm randomised controlled feasibility trial. SETTING Primary care. PARTICIPANTS Twenty-five adult patients with chronic pain and insomnia. INTERVENTION Hybrid CBT or self-help control intervention. PRIMARY AND SECONDARY OUTCOME MEASURES Primary outcomes measures were the Insomnia Severity Index and interference scale of the Brief Pain Inventory (BPI). Secondary outcomes measures were the present pain intensity rating from the BPI, Multidimensional Fatigue Inventory, Hospital Anxiety and Depression Scale and EQ-5D-5L. RESULTS Fourteen participants were randomised to receive Hybrid CBT, 11 to receive the self-help control treatment. Of the 14 in the Hybrid CBT group, 9 (64%) completed all four treatment sessions (4 discontinued due to poor health; 1 due to time constraints). Adherence to the self-help control treatment was not monitored. The total number of participants completing the 12-week and 24-week follow-ups were 12 (6 in each group; Hybrid CBT: 43%; self-help: 55%) and 10 (5 in each group; Hybrid CBT: 36%; self-help: 45%). Based on the data available, candidate outcome measures appeared to be sensitive to changes associated with interventions. Thematic analysis of pre-postintervention interview data revealed satisfaction with treatment content among those who completed the Hybrid CBT, whereas those in the self-help control treatment wanted more contact hours and therapist guidance. Other practical suggestions for improvement included shortening the duration of each treatment session, reducing the amount of assessment paperwork, and minimising the burden of sleep and pain monitoring. CONCLUSION Important lessons were learnt with regard to the infrastructure required to achieve better patient adherence and retention. Based on the qualitative feedback provided by a subset of treatment completers, future trials should also consider lowering the intensity of treatment and streamlining the data collection procedure. TRIAL REGISTRATION NUMBER ISRCTN17294365.",2020,"To test the feasibility of implementing a brief but intensive hybrid cognitive behavioural therapy (Hybrid CBT) for pain-related insomnia. ","['pain-related insomnia in primary care', 'Twenty-five adult patients with chronic pain and insomnia', 'Fourteen participants', 'pain-related insomnia']","['Hybrid CBT', 'Hybrid CBT or self-help control intervention', 'intensive hybrid cognitive behavioural therapy (Hybrid CBT', 'hybrid cognitive-behavioural therapy']","['burden of sleep and pain monitoring', 'pain intensity rating from the BPI, Multidimensional Fatigue Inventory, Hospital Anxiety and Depression Scale and EQ-5D-5L', 'Insomnia Severity Index and interference scale of the Brief Pain Inventory (BPI']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}, {'cui': 'C0222045'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}]",25.0,0.0597483,"To test the feasibility of implementing a brief but intensive hybrid cognitive behavioural therapy (Hybrid CBT) for pain-related insomnia. ","[{'ForeName': 'Nicole K Y', 'Initials': 'NKY', 'LastName': 'Tang', 'Affiliation': 'Department of Psychology, University of Warwick, Coventry, West Midlands, UK N.Tang@warwick.ac.uk.'}, {'ForeName': 'Corran', 'Initials': 'C', 'LastName': 'Moore', 'Affiliation': 'Department of Psychology, University of Leicester, Leicester, Leicestershire, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Parsons', 'Affiliation': 'Clinical Trials Unit, University of Warwick, Warwick Medical School, Coventry, West Midlands, UK.'}, {'ForeName': 'Harbinder Kaur', 'Initials': 'HK', 'LastName': 'Sandhu', 'Affiliation': 'Clinical Trials Unit, University of Warwick, Warwick Medical School, Coventry, West Midlands, UK.'}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Clinical Trials Unit, University of Warwick, Warwick Medical School, Coventry, West Midlands, UK.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Ellard', 'Affiliation': 'Clinical Trials Unit, University of Warwick, Warwick Medical School, Coventry, West Midlands, UK.'}, {'ForeName': 'Vivien P', 'Initials': 'VP', 'LastName': 'Nichols', 'Affiliation': 'Clinical Trials Unit, University of Warwick, Warwick Medical School, Coventry, West Midlands, UK.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Madan', 'Affiliation': 'Clinical Trials Unit, University of Warwick, Warwick Medical School, Coventry, West Midlands, UK.'}, {'ForeName': 'Victoria Elizabeth Janet', 'Initials': 'VEJ', 'LastName': 'Collard', 'Affiliation': 'Department of Psychology, University of Warwick, Coventry, West Midlands, UK.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Sharma', 'Affiliation': 'Patient Representative, Coventry, West Mindlands, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Underwood', 'Affiliation': 'Clinical Trials Unit, University of Warwick, Warwick Medical School, Coventry, West Midlands, UK.'}]",BMJ open,['10.1136/bmjopen-2019-034764'] 96,32298445,Participant food and activity costs in a translational Diabetes Prevention Program.,"The Diabetes Prevention Program (DPP) and its translational adaptations have been shown to be effective. However, individual-level economic impacts, such as the out-of-pocket costs borne by participants due to involvement in these programs have not been consistently and thoroughly evaluated. As cost is an important consideration that will impact the willingness of individuals to participate in such programs, this study examined direct monetary costs to participants in the Group Lifestyle Balance (GLB) DPP. Older adults (n = 134, mean age 62.8 years) with body mass index (BMI) ≥24 kg/m2 and prediabetes and/or metabolic syndrome participated in this GLB intervention, with two-thirds randomized to begin the intervention immediately and one-third functioning as a control for 6 months before receiving the entire intervention. Food and activity time and costs borne by participants were measured by self-report at baseline and after 6 months. Significant improvements in clinical metabolic measures, weight, and physical activity levels were achieved after 6 months in the intervention group compared both with baseline and the controls. Food costs did not increase among intervention participants. Costs related to physical activity did not change consistently over the course of the intervention. This DPP-GLB lifestyle intervention was effective in reducing risk factors for Type 2 diabetes mellitus among a diverse group of older participants without significantly increasing their out-of-pocket costs for food or physical activity over the course of the intervention. These results should help reduce concerns of individuals who are hesitant to participate in similar programs due to costs. The clinical trial registration number of this study is NCT01050205.",2021,"Significant improvements in clinical metabolic measures, weight, and physical activity levels were achieved after 6 months in the intervention group compared both with baseline and the controls.","['Older adults (n = 134, mean age 62.8 years) with body mass index']","['GLB intervention', 'DPP-GLB lifestyle intervention']","['risk factors', 'Participant food and activity costs', 'Food costs', 'clinical metabolic measures, weight, and physical activity levels', 'Food and activity time and costs borne']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}]",134.0,0.0137553,"Significant improvements in clinical metabolic measures, weight, and physical activity levels were achieved after 6 months in the intervention group compared both with baseline and the controls.","[{'ForeName': 'Gerald L', 'Initials': 'GL', 'LastName': 'Schafer', 'Affiliation': 'Carroll College, Department of Health Sciences, Helena, MT, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Songer', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, USA.'}, {'ForeName': 'Vincent C', 'Initials': 'VC', 'LastName': 'Arena', 'Affiliation': 'Department of Biostatistics, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, USA.'}, {'ForeName': 'M Kaye', 'Initials': 'MK', 'LastName': 'Kramer', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, USA.'}, {'ForeName': 'Rachel G', 'Initials': 'RG', 'LastName': 'Miller', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, USA.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Kriska', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, USA.'}]",Translational behavioral medicine,['10.1093/tbm/ibaa031'] 97,32200138,Osimertinib in T790M-positive and -negative patients with EGFR-mutated advanced non-small cell lung cancer (the TREM-study).,"OBJECTIVES In non-small cell lung cancer patients with acquired resistance to first- or second-generation EGFR-TKIs, osimertinib is approved in the presence of the T790 M resistance mutation. We assessed the efficacy of osimertinib in both T790M-positive and T790M-negative patients. MATERIALS AND METHODS The TREM-study is an investigator-initiated, multi-centre, single-arm, phase 2 clinical trial conducted in five Northern European countries. Patients with progression on at least one previous EGFR-TKI were assigned to treatment with 80 mg of osimertinib daily until radiological progression or death. Patients were included regardless of the presence of T790 M. The primary endpoint was objective response rate (ORR). RESULTS Of 199 included patients, 120 (60 %) were T790M-positive, 52 (26 %) were T790M-negative and 27 (14 %) had unknown T790M-status. 24 % had brain metastases and 15 % had an ECOG performance status of 2. Overall ORR was 48 % (95 % CI, 41 %-55 %), 60 % (51 %-69 %) for T790M-positive patients and 28 % (15 %-41 %) for T790M-negative patients, p < 0.001. ORR for patients with co-occurring del19 vs L858R was 61 % vs 32 %, p = 0.001. Duration of response was similar between the T790M-positive and -negative groups (11.8 vs 10.7 months, p = 0.229). Overall median progression-free survival (PFS) was 8.9 months (95 % CI, 7.4-10.5), and 10.8 vs 5.1 months for T790M-positive vs -negative patients (HR 0.62, p = 0.007). Median overall survival (OS) was 17.9 months (95 % CI, 14.4-21.3). For T790M-positive vs -negative median OS was 22.5 vs 13.4 months, (HR 0.55, p = 0.002). CONCLUSIONS This study confirms the efficacy of osimertinib for T790M-positive patients. There was also clinically significant activity of osimertinib in a proportion of T790M-negative patients. CLINICAL TRIAL REGISTRATION This trial is registered with ClinicalTrials.gov (NCT02504346).",2020,"Median overall survival (OS) was 17.9 months (95 % CI, 14.4-21.3).","['Of 199 included patients, 120 (60 %) were T790M-positive, 52 (26 %) were T790M-negative and 27 (14 %) had unknown T790M-status', 'Patients with progression on at least one previous EGFR-TKI', 'T790M-positive patients', 'non-small cell lung cancer patients with acquired resistance to first- or second-generation EGFR-TKIs, osimertinib is approved in the presence of the T790 M resistance mutation', 'Patients were included regardless of the presence of T790 M', 'T790M-positive and -negative patients with EGFR-mutated advanced non-small cell lung cancer (the TREM-study', 'T790M-positive and T790M-negative patients']",[],"['Duration of response', 'Median overall survival (OS', 'objective response rate (ORR', 'ORR', 'Overall ORR', 'ECOG performance status', 'brain metastases', 'Overall median progression-free survival (PFS']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0439661', 'cui_str': 'Acquired (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C4058811', 'cui_str': 'osimertinib'}, {'cui': 'C0205540', 'cui_str': 'Approved (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain (disorder)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",199.0,0.302362,"Median overall survival (OS) was 17.9 months (95 % CI, 14.4-21.3).","[{'ForeName': 'Inger Johanne Zwicky', 'Initials': 'IJZ', 'LastName': 'Eide', 'Affiliation': 'Vestre Viken Hospital Trust, Drammen, Norway; Department of Cancer Genetics, Institute for Cancer Research, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway. Electronic address: ingei@vestreviken.no.'}, {'ForeName': 'Åslaug', 'Initials': 'Å', 'LastName': 'Helland', 'Affiliation': 'Department of Cancer Genetics, Institute for Cancer Research, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway; Departement of Oncology, Oslo University Hospital, Oslo, Norway; University of Oslo, Department of Clinical Medicine, Oslo, Norway.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Ekman', 'Affiliation': 'Thoracic Oncology Center, Karolinska University Hospital/Departement of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Mellemgaard', 'Affiliation': 'Herlev Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Karin Holmskov', 'Initials': 'KH', 'LastName': 'Hansen', 'Affiliation': 'Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Saulius', 'Initials': 'S', 'LastName': 'Cicenas', 'Affiliation': 'National Cancer Institute, VU MF, Vilnius, Lithuania.'}, {'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Koivunen', 'Affiliation': 'Oulu University Hospital, University of Oulu, MRC Oulu, Oulu, Finland.'}, {'ForeName': 'Bjørn Henning', 'Initials': 'BH', 'LastName': 'Grønberg', 'Affiliation': ""Department of Clinical and Molecular Medicine, NTNU, Norwegian University of Science and Technology, Trondheim, Norway; Department of Oncology, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway.""}, {'ForeName': 'Odd Terje', 'Initials': 'OT', 'LastName': 'Brustugun', 'Affiliation': 'Vestre Viken Hospital Trust, Drammen, Norway; Department of Cancer Genetics, Institute for Cancer Research, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.03.009'] 98,31305505,CORRELATION OF SUBRETINAL HYPERREFLECTIVE MATERIAL MORPHOLOGY AND VISUAL ACUITY IN NEOVASCULAR AGE-RELATED MACULAR DEGENERATION.,"PURPOSE To evaluate the association of subretinal hyperreflective material (SHRM) morphological features with visual acuity in eyes with neovascular age-related macular degeneration. METHODS Retrospective analysis of treatment-naïve patients with neovascular age-related macular degeneration enrolled in randomized anti-vascular endothelial growth factor (VEGF) and anti-platelet-derived growth factor clinical trials. Standardized spectral domain optical coherence tomography images were graded at baseline, 12-week, and 24-week follow-up visits. Masked readers evaluated the morphology of SHRM (reflectivity, shape, anterior, and posterior boundaries) and measured SHRM height, width, and area at the fovea, within the center 1 mm, and outside the center 1 mm. RESULTS Baseline SHRM characteristics that correlated with worse visual acuity at 12 and 24 weeks included layered appearance (P = 0.006, 0.001), hyperreflective spots in SHRM (P = 0.001, 0.011), and separation between SHRM and outer retina (P = 0.03, 0.019). The disappearance of SHRM correlated with better visual acuity at Weeks 12 and 24 (P < 0.001). Layered appearance of SHRM at baseline was significantly associated with increased reflectivity at Weeks 12 and 24 (P = 0.009, 0.003). Decreasing reflectivity of SHRM lesion at Weeks 12 and 24 correlated with better visual acuity (P < 0.01, 0.01). Increased width and area of baseline SHRM at the foveal center correlated with worse visual acuity at 12 (P < 0.001, <0.001) and 24 weeks (<0.001, <0.001). CONCLUSION Several attributes of SHRM including, layered appearance, increased reflectivity, larger size, and hyperreflective spots correlated with worse visual acuity at 12- and 24-week follow-ups. Baseline SHRM characteristics can help practitioners predict visual and morphological prognosis and guide therapy.",2020,The disappearance of SHRM correlated with better visual acuity at Weeks 12 and 24 (P < 0.001).,"['Retrospective analysis of treatment-naïve patients with neovascular age-related macular degeneration enrolled in', 'eyes with neovascular age-related macular degeneration']",['randomized anti-vascular endothelial growth factor (VEGF'],"['hyperreflective spots in SHRM', 'morphology of SHRM (reflectivity, shape, anterior, and posterior boundaries) and measured SHRM height, width, and area at the fovea', 'layered appearance', 'Layered appearance of SHRM', 'visual acuity', 'Increased width and area of baseline SHRM', 'disappearance of SHRM', 'layered appearance, increased reflectivity, larger size, and hyperreflective spots', 'Decreasing reflectivity of SHRM lesion']","[{'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}]","[{'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]",,0.15083,The disappearance of SHRM correlated with better visual acuity at Weeks 12 and 24 (P < 0.001).,"[{'ForeName': 'Jaya B', 'Initials': 'JB', 'LastName': 'Kumar', 'Affiliation': 'Department of Ophthalmology, Duke University, Durham, North Carolina.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Stinnett', 'Affiliation': 'Department of Ophthalmology, Duke University, Durham, North Carolina.'}, {'ForeName': 'Jung I L', 'Initials': 'JIL', 'LastName': 'Han', 'Affiliation': 'Department of Ophthalmology, Duke University, Durham, North Carolina.'}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Jaffe', 'Affiliation': 'Department of Ophthalmology, Duke University, Durham, North Carolina.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002552'] 99,32300812,"Letter to the Editor: ""Twice as High Diet-Induced Thermogenesis After Breakfast vs Dinner on High-Calorie as Well as Low-Calorie Meals"".",,2020,,[],['High Diet-Induced Thermogenesis'],[],[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0018841', 'cui_str': 'Heat Production'}]",[],,0.0175443,,"[{'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Melanson', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Kong Y', 'Initials': 'KY', 'LastName': 'Chen', 'Affiliation': 'Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa208'] 100,32300831,C-reactive protein as marker of post-operative analgesic quality after primary total knee arthroplasty.,"OBJECTIVE To study the correlation between the level of C-reactive protein (CRP) and the severity of pain in the post-operative period with primary total knee arthroplasty and to conduct a comparative assessment of these indicators with various methods of pain relief. The primary hypothesis of the investigation was that post-operative CRP level is likely to be correlated with the severity of post-operative pain after total knee arthroplasty. The secondary points were the evaluation of CRP and pain syndrome in the groups, as well as the identification of the correlation between the level of CRP and the method of analgesia. MATERIALS AND METHODS Peri-operative levels of CRP and pain syndrome (10-point visual analogue scale) studied 160 patients with grade III gonarthrosis who have underwent primary total knee arthroplasty under conditions of subarachnoid anaesthesia in the period from years 2017 to 2019. Depending on the method of post-operative analgesia, patients were divided into five groups: group 1 had only systemic multimodal analgesia (SMA, n = 56), group 2 were treated with the epidural analgesia (EDA, n = 20), group 3 had local high-volume infiltration anaesthesia (LHVIA, n = 20), group 4 were getting LHVIA with a wound catheter (LHVIAc, n = 48), and group 5 had a single blockade of the femoral nerve (FNB, n = 16). RESULTS A direct strong correlation was obtained between the level of CRP and the severity of pain syndrome in the knee joint during movement in four to six hours after surgery (n = 160, Kendall coefficient τ = 0.230, p = 0,000) and on the first post-operative day (n = 160, τ = 0.21, p = 0.001). The increase in CRP (the difference between pre-operative and post-operative CRP levels) also was positively correlated with the severity of pain in the post-operative period (n = 160, τ = 0.257, p = 0.000 and τ = 0.187, p = 0.001, respectively). CRP level significantly has increased in the post-operative period (p = 0,000). The lowest CRP indicators in the first post-operative day were recorded during the infiltrative anaesthesia (3rd and 4th groups);, the highest were during the administration of SMA group (1st group). CONCLUSION The results confirm the correlation between the level of CRP and the severity of pain syndrome in the early post-operative period after total knee arthroplasty, its dependence on the method of analgesia, and allow to use it as a criterion for evaluating of the effectiveness of analgesia.",2020,A direct strong correlation was obtained between the level of CRP and the severity of pain syndrome in the knee joint during movement in four to six hours after surgery (n = ,"['Peri-operative levels of CRP and pain syndrome (10-point visual analogue scale) studied 160 patients with grade III gonarthrosis who have underwent primary total knee arthroplasty under conditions of subarachnoid anaesthesia in the period from years 2017 to 2019', 'primary total knee arthroplasty']","['C-reactive protein (CRP', 'SMA', 'systemic multimodal analgesia (SMA, n\u2009=\u200956), group 2 were treated with the epidural analgesia (EDA, n\u2009=\u200920), group 3 had local high-volume infiltration anaesthesia (LHVIA, n\u2009=\u200920), group 4 were getting LHVIA with a wound catheter (LHVIAc, n\u2009=\u200948), and group 5 had a single blockade of the femoral nerve (FNB, n\u2009=\u200916']","['level of CRP and the severity of pain syndrome', 'severity of pain', 'evaluation of CRP and pain syndrome', 'CRP', 'lowest CRP indicators', 'CRP level', 'pain relief']","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0391976', 'cui_str': 'Pain Disorder'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0038527', 'cui_str': 'Subarachnoid space structure'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0026847', 'cui_str': 'Spinal muscular atrophy'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0162359', 'cui_str': 'Hypohidrotic X-linked ectodermal dysplasia'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0234945', 'cui_str': 'Infiltration anaesthesia'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0015808', 'cui_str': 'Structure of femoral nerve'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0391976', 'cui_str': 'Pain Disorder'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",160.0,0.0212272,A direct strong correlation was obtained between the level of CRP and the severity of pain syndrome in the knee joint during movement in four to six hours after surgery (n = ,"[{'ForeName': 'Dmitry A', 'Initials': 'DA', 'LastName': 'Tarasov', 'Affiliation': 'I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Alexey V', 'Initials': 'AV', 'LastName': 'Lychagin', 'Affiliation': 'I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Andrei G', 'Initials': 'AG', 'LastName': 'Yavorovkiy', 'Affiliation': 'I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Marina M', 'Initials': 'MM', 'LastName': 'Lipina', 'Affiliation': 'I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation, Sechenov University, Moscow, Russia. marina.lipina@icloud.com.'}, {'ForeName': 'Irina A', 'Initials': 'IA', 'LastName': 'Tarasova', 'Affiliation': 'I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation, Sechenov University, Moscow, Russia.'}]",International orthopaedics,['10.1007/s00264-020-04551-8'] 101,32303499,Long-term outcomes of treat-and-extend ranibizumab with and without navigated laser for diabetic macular oedema: TREX-DME 3-year results.,"BACKGROUND/AIMS To evaluate the long-term effects of treat-and-extend dosing of ranibizumab with and without navigated focal laser for diabetic macular oedema (DME). METHODS This is a multicentre, randomised clinical trial where 150 eyes were randomised into three cohorts; Monthly (n=30), TReat and EXtend without macular laser photocoagulation (TREX; n=60), and treat and extend with angiography-GuIded macular LAser photocoagulation (GILA; n=60). During the first 2 years, eyes either received ranibizumab 0.3 mg every 4 weeks or underwent treat-and-extend ranibizumab with or without angiography-guided laser therapy. In the third year, all eyes were treated as needed with ranibizumab for >5 letters vision loss or if the central retinal thickness (CRT) was >325 µm, and all eyes were eligible to receive focal laser. RESULTS 109 eyes (73%) completed the 3-year end-point. At week 156, mean best-corrected visual acuity (BCVA) and CRT improved by 6.9, 9.7, 9.5 letters (p=0.60) and 129, 138, 165 µm (p=0.39), in the Monthly, TREX and GILA cohorts, respectively. These improvements were reached prior to week 104 and no significant changes occurred from week 104 to week 156 (BCVA: p=0.34; CRT: p=0.36). The mean number of injections in the third year was 3.0, 3.1, and 2.4 in the Monthly, TREX and GILA cohorts, respectively (p=0.56). 86 eyes (79%) required at least one ranibizumab injection in the third year. CONCLUSION The improvements achieved after 2 years of treat-and-extend ranibizumab for DME were maintained in the third year with a mean of 3 intravitreal injections. TRIAL REGISTRATION NUMBER FDA IND 119146, NCT01934556.",2021,These improvements were reached prior to week 104 and no significant changes occurred from week 104 to week 156 (BCVA: p=0.34; CRT: p=0.36).,"['diabetic macular oedema', '150 eyes were randomised into three cohorts; Monthly (n=30', 'diabetic macular oedema (DME']","['ranibizumab with and without navigated focal laser', 'ranibizumab', 'TReat and EXtend without macular laser photocoagulation (TREX; n=60), and treat and extend with angiography-GuIded macular LAser photocoagulation', 'ranibizumab 0.3\u2009mg every 4\u2009weeks or underwent treat-and-extend ranibizumab with or without angiography-guided laser therapy', 'treat-and-extend ranibizumab with and without navigated laser']","['mean best-corrected visual acuity (BCVA) and CRT', 'mean number of injections']","[{'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0023694', 'cui_str': 'Photocoagulation'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]",150.0,0.139157,These improvements were reached prior to week 104 and no significant changes occurred from week 104 to week 156 (BCVA: p=0.34; CRT: p=0.36).,"[{'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Payne', 'Affiliation': 'Palmetto Retina Center, West Columbia, South Carolina, USA jpayne@palmettoretina.com.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Blanton Eye Institute, Houston Methodist Hospital and Weill Cornell Medical College, Retina Consultants of Houston, Houston, Texas, USA.'}, {'ForeName': 'W Lloyd', 'Initials': 'WL', 'LastName': 'Clark', 'Affiliation': 'Palmetto Retina Center, West Columbia, South Carolina, USA.'}, {'ForeName': 'Beau B', 'Initials': 'BB', 'LastName': 'Bruce', 'Affiliation': 'Department of Ophthalmology, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Boyer', 'Affiliation': 'Ophthalmology, University of Southern California, Sherman Oaks, California, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Brown', 'Affiliation': 'The Methodist Hospital, Houston, TX, Houston, Texas, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2020-316176'] 102,32003735,Efficacy of a novel oral appliance and the role of posture on nasal resistance in obstructive sleep apnea.,"STUDY OBJECTIVES High nasal resistance is associated with oral appliance treatment failure in obstructive sleep apnea (OSA). A novel oral appliance with a built-in oral airway has been shown to reduce pharyngeal pressure swings during sleep and may be efficacious in those with high nasal resistance. The role of posture and mandibular advancement on nasal resistance in OSA remains unclear. This study aimed to determine (1) the effects of posture and mandibular advancement on nasal resistance in OSA and (2) the efficacy of a new oral appliance device including in patients with high nasal resistance. METHODS A total of 39 people with OSA (7 females, apnea-hypopnea index (AHI) (mean ± standard deviation) = 29 ± 21 events/h) completed split-night polysomnography with and without oral appliance (order randomized). Prior to sleep, participants were instrumented with a nasal mask, pneumotachograph, and a choanal pressure catheter for gold standard nasal resistance quantification seated, supine and lateral (with and without oral appliance, order randomized). RESULTS Awake nasal resistance increased from seated, to supine, to lateral posture (median [interquartile range] = 1.8 [1.4, 2.7], 2.7 [1.7, 3.5], 3.4 [1.9, 4.6] cm H₂O/L/s, P < .001). Corresponding measures of nasal resistance did not change with mandibular advancement (2.3 [1.4, 3.5], 2.5 [1.8, 3.6], 3.5 [1.9, 4.8] cm H₂O/L/s, P = .388). The median AHI reduced by 47% with oral appliance therapy (29 ± 21 versus 18 ± 15 events/h, P = .002). Participants with high nasal resistance (> 3 cm H₂O/L/s) had similar reductions in AHI versus those with normal nasal resistance (61 [-8, 82] versus 40 [-5, 62] %, P = .244). CONCLUSIONS Nasal resistance changes with posture in people with OSA. A novel oral appliance with a built-in oral airway reduces OSA severity in people with OSA, including in those with high nasal resistance. CLINICAL TRIAL REGISTRATION Registry: ANZCTR; Title: Combination therapy for obstructive sleep apnoea; Identifier: ACTRN12617000492358; URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372279.",2020,"Participants with high nasal resistance (>3cmH₂O/L/s) had similar reductions in AHI versus those with normal nasal resistance (61 [-8,82] vs. 40 [-5,62]%, p=0.244). ","['Participants with high nasal resistance (>3cmH₂O/L/s', 'patients with high nasal resistance', '39 people with OSA (7 females, AHI (mean±SD)= 29±21events/h) completed', 'Obstructive Sleep Apnea', 'people with OSA']","['split-night polysomnography with and without OA', 'new OA device', 'posture and mandibular advancement', 'Novel Oral Appliance', 'nasal mask, pneumotachograph, and a choanal pressure catheter for gold standard nasal resistance quantification seated, supine and lateral (with and without OA, order randomized']","['nasal resistance', 'OSA severity', 'Awake nasal resistance', 'median AHI']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0429208', 'cui_str': 'Nasal resistance (observable entity)'}, {'cui': 'C0439394', 'cui_str': 'L/s'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C0376461', 'cui_str': 'Mandibular Advancement'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0243112'}, {'cui': 'C2711254', 'cui_str': 'Dental mask'}, {'cui': 'C0182334', 'cui_str': 'Pneumotachograph (physical object)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0429208', 'cui_str': 'Nasal resistance (observable entity)'}, {'cui': 'C1283233', 'cui_str': 'Seating'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}]","[{'cui': 'C0429208', 'cui_str': 'Nasal resistance (observable entity)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0234422', 'cui_str': 'Awake (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",39.0,0.0416219,"Participants with high nasal resistance (>3cmH₂O/L/s) had similar reductions in AHI versus those with normal nasal resistance (61 [-8,82] vs. 40 [-5,62]%, p=0.244). ","[{'ForeName': 'Benjamin K', 'Initials': 'BK', 'LastName': 'Tong', 'Affiliation': 'Neuroscience Research Australia (NeuRA), Sydney, New South Wales, Australia.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Tran', 'Affiliation': 'Neuroscience Research Australia (NeuRA), Sydney, New South Wales, Australia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ricciardiello', 'Affiliation': 'Neuroscience Research Australia (NeuRA), Sydney, New South Wales, Australia.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Chiang', 'Affiliation': 'Neuroscience Research Australia (NeuRA), Sydney, New South Wales, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Donegan', 'Affiliation': 'Neuroscience Research Australia (NeuRA), Sydney, New South Wales, Australia.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Murray', 'Affiliation': 'Prince of Wales Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Szollosi', 'Affiliation': 'The Prince Charles Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Amatoury', 'Affiliation': 'Neuroscience Research Australia (NeuRA), Sydney, New South Wales, Australia.'}, {'ForeName': 'Jayne C', 'Initials': 'JC', 'LastName': 'Carberry', 'Affiliation': 'Neuroscience Research Australia (NeuRA), Sydney, New South Wales, Australia.'}, {'ForeName': 'Danny J', 'Initials': 'DJ', 'LastName': 'Eckert', 'Affiliation': 'Neuroscience Research Australia (NeuRA), Sydney, New South Wales, Australia.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8244'] 103,32003737,Effectiveness of an intensive weight-loss program for severe OSA in patients undergoing CPAP treatment: a randomized controlled trial.,"STUDY OBJECTIVES To determine whether an intensive weight-loss program (IWLP) is effective for reducing weight, the severity of obstructive sleep apnea (OSA), and metabolic variables in patients with obesity and severe OSA undergoing continuous positive airway pressure treatment. METHODS Forty-two patients were randomized to the control (CG, n = 20) or the intervention group (IG, n = 22), who followed a 12-month IWLP. The primary outcome was a reduction in the apnea-hypopnea index (AHI) as measured at 3 and 12 months by full polysomnography. Metabolic variables, blood pressure, body fat composition by bioimpedance, carotid intima media thickness, and visceral fat by computed tomography were also assessed. RESULTS Mean age was 49 (6.7) years, body mass index 35 (2.7) kg/m², and AHI 69 (20) events/h. Weight reduction was higher for the IG than the CG at 3 and 12 months, -10.5 versus -2.3 kg (P < .001), and -8.2 versus -0.1 kg (P < .001), respectively, as was loss of visceral fat at 12 months. AHI decreased more in the IG at 3 months (-23.72 versus -9 events/h) but the difference was not significant at 12 months, though 28% of patients from the IG had an AHI < 30 events/h compared to none in the CG (P = .046). At 12 months, the IG showed a reduction in C-reactive protein (P = .013), glycated hemoglobin (P = .031) and an increase in high density lipoprotein cholesterol (P = .027). CONCLUSIONS An IWLP in patients with obesity and severe OSA is effective for reducing weight and OSA severity. It also results in an improvement in lipid profiles, glycemic control, and inflammatory markers. CLINICAL TRIAL REGISTRATION Registry: ClinicalTrials.gov; Title: Effectiveness of an Intensive Weight Loss Program for Obstructive Sleep Apnea Syndrome (OSAS) Treatment; Identifier: NCT02832414; URL: https://clinicaltrials.gov/ct2/show/record/NCT02832414.",2020,"At 12 months, the IG showed a reduction in C-reactive protein (p=0.013), glycated hemoglobin (p=0.031) and an increase in high density lipoprotein cholesterol (p=0.027). ","['Severe Obstructive Sleep Apnea Syndrome (OSA) in Patients Undergoing CPAP Treatment', '42 patients', 'patients with obesity and severe OSA undergoing continuous positive airway pressure treatment', 'patients with obesity and severe OSA', 'Mean age was 49(6.7) years, body mass index 35(2.7) kg/m² and AHI 69(20) events/h']","['IWLP', 'Intensive Weight-Loss Program', 'intensive weight-loss program (IWLP']","['C-reactive protein', 'glycated hemoglobin', 'apnea-hypopnea index (AHI', 'Weight reduction', 'AHI', 'high density lipoprotein cholesterol', 'weight and OSA severity', 'lipid profiles, glycemic control and inflammatory markers', 'Metabolic variables, blood pressure, body fat composition by bioimpedance, carotid intima media thickness and visceral fat by computed tomography scan']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]","[{'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}]","[{'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0441633'}]",42.0,0.052317,"At 12 months, the IG showed a reduction in C-reactive protein (p=0.013), glycated hemoglobin (p=0.031) and an increase in high density lipoprotein cholesterol (p=0.027). ","[{'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'López-Padrós', 'Affiliation': ""Multidisciplinary Sleep Unit, Department of Respiratory Medicine, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Spain.""}, {'ForeName': 'Neus', 'Initials': 'N', 'LastName': 'Salord', 'Affiliation': ""Multidisciplinary Sleep Unit, Department of Respiratory Medicine, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Spain.""}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Alves', 'Affiliation': ""Section of Endocrinology, Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Spain.""}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Vilarrasa', 'Affiliation': ""Section of Endocrinology, Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Spain.""}, {'ForeName': 'Merce', 'Initials': 'M', 'LastName': 'Gasa', 'Affiliation': ""Multidisciplinary Sleep Unit, Department of Respiratory Medicine, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Spain.""}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Planas', 'Affiliation': ""Department of Rehabilitation, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Spain.""}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Montsserrat', 'Affiliation': ""Department of Endocrinology and Nutrition Department, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Spain.""}, {'ForeName': 'M Nuria', 'Initials': 'MN', 'LastName': 'Virgili', 'Affiliation': ""Section of Endocrinology, Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Spain.""}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Rodríguez', 'Affiliation': ""Multidisciplinary Sleep Unit, Department of Respiratory Medicine, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Spain.""}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Pérez-Ramos', 'Affiliation': ""Multidisciplinary Sleep Unit, Department of Respiratory Medicine, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Spain.""}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'López-Cadena', 'Affiliation': 'Respiratory Medicine Department, Hospital Universitari Sagrat Cor, Barcelona, Spain.'}, {'ForeName': 'M Inmaculata', 'Initials': 'MI', 'LastName': 'Ramos', 'Affiliation': 'LINDE Healthcare, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Dorca', 'Affiliation': ""Multidisciplinary Sleep Unit, Department of Respiratory Medicine, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Spain.""}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Monasterio', 'Affiliation': ""Multidisciplinary Sleep Unit, Department of Respiratory Medicine, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Spain.""}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8252'] 104,32299733,Prospective randomized multicentre comparison on sibling oocytes comparing G-Series media system with antioxidants versus standard G-Series media system.,"RESEARCH QUESTION Does the inclusion of three antioxidants (A3), acetyl-l-carnitine (ALC), N-acetyl-l-cysteine (NAC) and alpha-lipoic acid (ALA) improve human embryo development and pregnancy potential? DESIGN Prospective randomized multicentre comparison of sibling oocytes. A total of 1563 metaphase II oocytes from 133 patients in two IVF centres. Day 3 embryo and day 5/6 blastocyst quality were assessed. Good embryo quality on day 3 was defined as 8 to 10 cells with even cells and low fragmentation; good quality blastocysts as 3BB or greater. Clinical outcome was assessed on transfers of fresh or vitrified-warmed blastocyst on day 5. RESULTS Of the two-pronuclei, 40.7% (G-Series) and 50.2% (G-Series with A3 group) resulted in good quality embryos on day 3 (P < 0.05). The implantation rate by fetal sac was 39.2% and 50.6%, and by fetal heartbeat was 37.8% and 47.1% for the G-Series and G-Series with A3 group, respectively. When stratified by female patient age, patients 35-40 years had an implantation rate by fetal sac and heart of 23.5% in the G-Series compared with 57.5% (P < 0.05) and 50.0% (P < 0.05) in the A3 group. The ongoing pregnancies in patients 35-40 years were significantly higher in the A3 group (50%) compared with the control (25.8%) (P < 0.05). CONCLUSIONS The presence of antioxidants during IVF and embryo culture for patients 35-40 years resulted in a significant increase in implantation and pregnancy rate. Supplementation of antioxidants to IVF and culture media may therefore improve the viability of human embryos in assisted reproductive technologies, plausibly through the reduction of oxidative stress.",2020,The presence of antioxidants during IVF and embryo culture for patients 35-40 years resulted in a significant increase in implantation and pregnancy rate.,['A total of 1563 metaphase II oocytes from 133 patients in two IVF centres'],"['three antioxidants (A3), acetyl-l-carnitine (ALC), N-acetyl-l-cysteine (NAC) and alpha-lipoic acid (ALA', 'G-Series media system with antioxidants versus standard G-Series media system']","['Good embryo quality', 'implantation rate by fetal sac and heart', 'transfers of fresh or vitrified-warmed blastocyst on day 5', 'implantation and pregnancy rate', 'fetal heartbeat', 'implantation rate by fetal sac', 'good quality embryos']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1621812', 'cui_str': 'Metaphase'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0001040', 'cui_str': 'Acetylcarnitine'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C1281743', 'cui_str': 'Blastocyst structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0425583', 'cui_str': 'Heart beat'}]",,0.091776,The presence of antioxidants during IVF and embryo culture for patients 35-40 years resulted in a significant increase in implantation and pregnancy rate.,"[{'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Gardner', 'Affiliation': 'School of BioSciences, University of Melbourne, Parkville, Australia; Melbourne IVF, East Melbourne, Australia. Electronic address: david.gardner@unimelb.edu.au.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kuramoto', 'Affiliation': ""Kuramoto Women's Clinic, Reproductive Medicine, Fukuoka, Japan.""}, {'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Tanaka', 'Affiliation': 'Kiba Park Clinic, Reproductive Medicine, Tokyo, Japan.'}, {'ForeName': 'Shigetoshi', 'Initials': 'S', 'LastName': 'Mitzumoto', 'Affiliation': ""Kuramoto Women's Clinic, Reproductive Medicine, Fukuoka, Japan.""}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Montag', 'Affiliation': 'ilabcomm GmbH, Eisenachstrasse 34, Sankt Augustin, Germany.'}, {'ForeName': 'Atsumi', 'Initials': 'A', 'LastName': 'Yoshida', 'Affiliation': 'Kiba Park Clinic, Reproductive Medicine, Tokyo, Japan.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.01.026'] 105,32299734,A randomized double-blinded non-inferiority trial comparing fentanyl and midazolam with pethidine and diazepam for pain relief during oocyte retrieval.,"RESEARCH QUESTION Is fentanyl and midazolam non-inferior to pethidine and diazepam in pain relief during oocyte retrieval under conscious sedation? DESIGN A randomized double-blinded non-inferiority trial of 170 infertile women undergoing oocyte retrieval under conscious sedation in an assisted reproduction centre. The women were randomized to receive intravenously either 0.1 mg fentanyl and 5 mg midazolam or 25 mg pethidine and 5 mg diazepam, plus paracervical block with 10 ml 1% lignocaine. The primary outcome was abdominal pain level during retrieval assessed by linear visual analogue scale from 0-10. Secondary outcomes included vaginal pain levels during and after retrieval and postoperative abdominal pain levels and side-effects, satisfaction level, clinical pregnancy and ongoing pregnancy rates. A pre-defined non-inferiority margin of 1 for the difference in pain levels between two groups was set. RESULTS Vaginal and abdominal pain levels during retrieval were significantly lower in the fentanyl and midazolam group compared with the pethidine and diazepam group (per-protocol analysis, vaginal pain: 1.6 versus 4.3; mean difference: -2.7, 95% CI -3.7, -1.8; P < 0.001; abdominal pain: 2.9 versus 5.2; mean difference: -2.3, 95% CI -3.3 to -1.3; P < 0.001 for non-inferiority). No differences were observed in these pain levels after retrieval. Most women experienced no postoperative side-effects. The fentanyl and midazolam group had better sedation level, satisfaction level on pain relief and satisfaction on the overall retrieval procedure than the pethidine and diazepam group. No significant differences were found in clinical pregnancy and ongoing pregnancy rates between the two groups. CONCLUSION The fentanyl and midazolam group had significantly lower vaginal and abdominal pain levels during oocyte retrieval than the pethidine and diazepam group.",2020,The fentanyl and midazolam group had significantly lower vaginal and abdominal pain levels during oocyte retrieval than the pethidine and diazepam group.,"['pain relief during oocyte retrieval', '170 infertile women undergoing oocyte retrieval under conscious sedation in an assisted reproduction centre']","['pethidine and 5 mg diazepam, plus paracervical block with 10 ml 1% lignocaine', 'fentanyl and 5 mg midazolam', 'pethidine', 'pethidine and diazepam', 'midazolam', 'diazepam', 'fentanyl and midazolam']","['postoperative side-effects', 'clinical pregnancy and ongoing pregnancy rates', 'pain levels', 'Vaginal and abdominal pain levels', 'vaginal and abdominal pain levels', 'vaginal pain levels during and after retrieval and postoperative abdominal pain levels and side-effects, satisfaction level, clinical pregnancy and ongoing pregnancy rates', 'abdominal pain', 'abdominal pain level during retrieval assessed by linear visual analogue scale', 'sedation level, satisfaction level on pain relief and satisfaction on the overall retrieval procedure']","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0404268', 'cui_str': 'Oocyte recovery'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0079159', 'cui_str': 'Conscious sedation'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0025376', 'cui_str': 'Meperidine'}, {'cui': 'C0012010', 'cui_str': 'Diazepam'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0030401', 'cui_str': 'Paracervical block anesthesia'}, {'cui': 'C2744579', 'cui_str': 'ATP8A2 protein, human'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0236082', 'cui_str': 'Vaginal pain'}, {'cui': 'C4047372', 'cui_str': 'Postoperative abdominal pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",170.0,0.597173,The fentanyl and midazolam group had significantly lower vaginal and abdominal pain levels during oocyte retrieval than the pethidine and diazepam group.,"[{'ForeName': 'Shui Fan', 'Initials': 'SF', 'LastName': 'Lai', 'Affiliation': 'Department of Obstetrics and Gynaecology, Kwong Wah Hospital, 25 Waterloo Road, Yau Ma Tei Kowloon, Hong Kong; Department of Obstetrics and Gynaecology, the University of Hong Kong, Hong Kong. Electronic address: lsf087@ha.org.hk.'}, {'ForeName': 'Mei Ting', 'Initials': 'MT', 'LastName': 'Lam', 'Affiliation': 'Department of Obstetrics and Gynaecology, Kwong Wah Hospital, 25 Waterloo Road, Yau Ma Tei Kowloon, Hong Kong; Department of Obstetrics and Gynaecology, the University of Hong Kong, Hong Kong.'}, {'ForeName': 'Hang Wun Raymond', 'Initials': 'HWR', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, Kwong Wah Hospital, 25 Waterloo Road, Yau Ma Tei Kowloon, Hong Kong; Department of Obstetrics and Gynaecology, the University of Hong Kong, Hong Kong.'}, {'ForeName': 'Ernest Hung Yu', 'Initials': 'EHY', 'LastName': 'Ng', 'Affiliation': 'Department of Obstetrics and Gynaecology, the University of Hong Kong, Hong Kong.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.01.021'] 106,31940222,Lateral Extra-articular Tenodesis Reduces Failure of Hamstring Tendon Autograft Anterior Cruciate Ligament Reconstruction: 2-Year Outcomes From the STABILITY Study Randomized Clinical Trial.,"BACKGROUND Persistent anterolateral rotatory laxity after anterior cruciate ligament (ACL) reconstruction (ACLR) has been correlated with poor clinical outcomes and graft failure. HYPOTHESIS We hypothesized that a single-bundle, hamstring ACLR in combination with a lateral extra-articular tenodesis (LET) would reduce the risk of ACLR failure in young, active individuals. STUDY DESIGN Randomized controlled trial; Level of evidence, 1. METHODS This is a multicenter, prospective, randomized clinical trial comparing a single-bundle, hamstring tendon ACLR with or without LET performed using a strip of iliotibial band. Patients 25 years or younger with an ACL-deficient knee were included and also had to meet at least 2 of the following 3 criteria: (1) grade 2 pivot shift or greater, (2) a desire to return to high-risk/pivoting sports, (3) and generalized ligamentous laxity (GLL). The primary outcome was ACLR clinical failure, a composite measure of rotatory laxity or a graft rupture. Secondary outcome measures included the P4 pain scale, Marx Activity Rating Scale, Knee injury Osteoarthritis and Outcome Score (KOOS), International Knee Documentation Committee score, and ACL Quality of Life Questionnaire. Patients were reviewed at 3, 6, 12, and 24 months postoperatively. RESULTS A total of 618 patients (297 males; 48%) with a mean age of 18.9 years (range, 14-25 years) were randomized. A total of 436 (87.9%) patients presented preoperatively with high-grade rotatory laxity (grade 2 pivot shift or greater), and 215 (42.1%) were diagnosed as having GLL. There were 18 patients lost to follow-up and 11 who withdrew (~5%). In the ACLR group, 120/298 (40%) patients sustained the primary outcome of clinical failure, compared with 72/291 (25%) in the ACLR+LET group (relative risk reduction [RRR], 0.38; 95% CI, 0.21-0.52; P < .0001). A total of 45 patients experienced graft rupture, 34/298 (11%) in the ACLR group compared with 11/291 (4%) in the ACL+LET group (RRR, 0.67; 95% CI, 0.36-0.83; P < .001). The number needed to treat with LET to prevent 1 patient from graft rupture was 14.3 over the first 2 postoperative years. At 3 months, patients in the ACLR group had less pain as measured by the P4 ( P = .003) and KOOS ( P = .007), with KOOS pain persisting in favor of the ACLR group to 6 months ( P = .02). No clinically important differences in patient-reported outcome measures were found between groups at other time points. The level of sports activity was similar between groups at 2 years after surgery, as measured by the Marx Activity Rating Scale ( P = .11). CONCLUSION The addition of LET to a single-bundle hamstring tendon autograft ACLR in young patients at high risk of failure results in a statistically significant, clinically relevant reduction in graft rupture and persistent rotatory laxity at 2 years after surgery. REGISTRATION NCT02018354 ( ClinicalTrials.gov identifier).",2020,"The level of sports activity was similar between groups at 2 years after surgery, as measured by the Marx Activity Rating Scale ( P = .11). ","['618 patients (297 males; 48%) with a mean age of 18.9 years (range, 14-25 years', 'Hamstring Tendon Autograft Anterior Cruciate Ligament Reconstruction', 'A total of 436 (87.9%) patients presented preoperatively with high-grade rotatory laxity (grade 2 pivot shift or greater), and 215 (42.1%) were diagnosed as having GLL', 'Patients 25 years or younger with an ACL-deficient knee were included and also had to meet at least 2 of the following 3 criteria: (1) grade 2 pivot shift or greater, (2) a desire to return to high-risk/pivoting sports, (3) and generalized ligamentous laxity (GLL']","['hamstring ACLR in combination with a lateral extra-articular tenodesis (LET', 'ACLR+LET', 'anterior cruciate ligament (ACL) reconstruction (ACLR', 'hamstring tendon ACLR with or without LET', 'LET', 'Lateral Extra-articular Tenodesis']","['Marx Activity Rating Scale', 'P4 pain scale, Marx Activity Rating Scale, Knee injury Osteoarthritis and Outcome Score (KOOS), International Knee Documentation Committee score, and ACL Quality of Life Questionnaire', 'KOOS pain persisting', 'pain', 'clinical failure', 'graft rupture and persistent rotatory laxity', 'KOOS', 'graft rupture', 'level of sports activity', 'ACLR clinical failure, a composite measure of rotatory laxity or a graft rupture']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0332536', 'cui_str': 'Laxness'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]","[{'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0205135', 'cui_str': 'Extra-articular (qualifier value)'}, {'cui': 'C1260974', 'cui_str': 'Tenodesis'}, {'cui': 'C0086562', 'cui_str': 'LET'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C1267157', 'cui_str': 'Hamstring Tendons'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0222045'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0443294', 'cui_str': 'Ruptured (qualifier value)'}, {'cui': 'C0332536', 'cui_str': 'Laxness'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",618.0,0.249471,"The level of sports activity was similar between groups at 2 years after surgery, as measured by the Marx Activity Rating Scale ( P = .11). ","[{'ForeName': 'Alan M J', 'Initials': 'AMJ', 'LastName': 'Getgood', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Dianne M', 'Initials': 'DM', 'LastName': 'Bryant', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Litchfield', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Heard', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'McCormack', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Rezansoff', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Devin', 'Initials': 'D', 'LastName': 'Peterson', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Bardana', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'MacDonald', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Peter C M', 'Initials': 'PCM', 'LastName': 'Verdonk', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Spalding', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Willits', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Birmingham', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Hewison', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Wanlin', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Firth', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Pinto', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Martindale', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': ""O'Neill"", 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Jennings', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Daniluk', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Dory', 'Initials': 'D', 'LastName': 'Boyer', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Mauri', 'Initials': 'M', 'LastName': 'Zomar', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Karyn', 'Initials': 'K', 'LastName': 'Moon', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Raely', 'Initials': 'R', 'LastName': 'Pritchett', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Krystan', 'Initials': 'K', 'LastName': 'Payne', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Fan', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Bindu', 'Initials': 'B', 'LastName': 'Mohan', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Buchko', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Laurie A', 'Initials': 'LA', 'LastName': 'Hiemstra', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kerslake', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Tynedal', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Stranges', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Mcrae', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'LeeAnne', 'Initials': 'L', 'LastName': 'Gullett', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Brown', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Legary', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Longo', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Mat', 'Initials': 'M', 'LastName': 'Christian', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Ferguson', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Mohtadi', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Rhamona', 'Initials': 'R', 'LastName': 'Barber', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Chan', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Campbell', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Garven', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Pulsifer', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Mayer', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Simunovic', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Duong', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Robinson', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Levy', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Skelly', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Ajaykumar', 'Initials': 'A', 'LastName': 'Shanmugaraj', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Howells', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Murray', 'Initials': 'M', 'LastName': 'Tough', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Spalding', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Pete', 'Initials': 'P', 'LastName': 'Thompson', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Metcalfe', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Asplin', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Alisen', 'Initials': 'A', 'LastName': 'Dube', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Clarkson', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Jaclyn', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Bolsover', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Bradshaw', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Belgrove', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Millan', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Turner', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Verdugo', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Lowe', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Dunne', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Kerri', 'Initials': 'K', 'LastName': 'McGowan', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Charlie-Marie', 'Initials': 'CM', 'LastName': 'Suddens', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Declercq', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Kristien', 'Initials': 'K', 'LastName': 'Vuylsteke', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Mieke', 'Initials': 'M', 'LastName': 'Van Haver', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}]",The American journal of sports medicine,['10.1177/0363546519896333'] 107,32297162,"Lidocaine as an element of multimodal analgesic therapy in major spine surgical procedures in children: a prospective, randomized, double-blind study.","BACKGROUND Introducing the principles of multimodal analgesic therapy is necessary to provide appropriate comfort for the patient after surgery. The main objective of the study was evaluating the influence of perioperative intravenous (i.v.) lidocaine infusion on postoperative morphine requirements during the first 48 h postoperatively in children undergoing major spine surgery. MATERIALS AND METHODS Prospective, randomized, double-blind study: 41 children, qualified to multilevel spine surgery, were randomly divided into two treatment groups: lidocaine and placebo (control). The lidocaine group received lidocaine as a bolus of 1.5 mg/kg over 30 minutes, followed by a continuous infusion at 1 mg/kg/h to 6 hours after surgery. The protocol of perioperative management was identical for all patients. MEASUREMENTS morphine demand, intensity of postoperative pain (the Numerical Rating Scale), oral feeding initiation time, first attempts at assuming erect position, postoperative quality of life (the Acute Short-form /SF-12/ health survey). RESULTS Patient data did not differ demographically. Compared to the control group, lidocaine treatment reduced the demand for morphine during the first 24h [95% CI 0.13 (0.11-0.28) mg/kg, p = 0.0122], 48h [95% CI 0.46 (0.22-0.52) mg/kg, p = 0.0299] after surgery and entire hospitalization [95% CI 0.58 (0.19-0.78) mg/kg, p = 0.04]; postoperative pain intensity; nutritional withdrawal period [introduction of liquid diet (p = 0.024) and solid diet (p = 0.012)], and accelerated the adoption of an upright position [sitting (p = 0.048); walking (p = 0.049)]. The SF-12 generic health survey did not differ between groups before operation, 2 months and 4 years after surgery. CONCLUSIONS Perioperative lidocaine administration, as a part of the applied analgesic therapy regimen, may decrease postoperative opioid demand and accelerates convalescence of children undergoing major surgery.",2020,"Compared to the control group, lidocaine treatment reduced the demand for morphine during the first 24h [95% CI 0.13 (0.11-0.28) mg/kg, p = 0.0122], 48h [95% CI 0.46 (0.22-0.52) mg/kg, p = 0.0299] after surgery and entire hospitalization","['children undergoing major surgery', '41 children, qualified to multilevel spine surgery', 'major spine surgical procedures in children', 'children undergoing major spine surgery']","['Lidocaine', 'lidocaine', 'lidocaine and placebo (control']","['demand for morphine', 'postoperative morphine requirements', 'entire hospitalization', 'postoperative pain intensity; nutritional withdrawal period [introduction of liquid diet', 'SF-12 generic health survey', 'morphine demand, intensity of postoperative pain (the Numerical Rating Scale), oral feeding initiation time, first attempts at assuming erect position, postoperative quality of life (the Acute Short-form /SF-12/ health survey', 'adoption of an upright position [sitting']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0920347', 'cui_str': 'Procedure on spinal cord'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0037216', 'cui_str': 'SITS'}]",41.0,0.143157,"Compared to the control group, lidocaine treatment reduced the demand for morphine during the first 24h [95% CI 0.13 (0.11-0.28) mg/kg, p = 0.0122], 48h [95% CI 0.46 (0.22-0.52) mg/kg, p = 0.0299] after surgery and entire hospitalization","[{'ForeName': 'Ilona', 'Initials': 'I', 'LastName': 'Batko', 'Affiliation': ""Department of Anesthesiology and Intensive Care, University Children's Hospital, 265 Wielicka St, 30-663, Cracow, Poland. ilona.batko@poczta.onet.pl.""}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Kościelniak-Merak', 'Affiliation': ""Department of Clinical Biochemistry, University Children's Hospital, Jagiellonian University Medical College, Cracow, Poland.""}, {'ForeName': 'Przemysław J', 'Initials': 'PJ', 'LastName': 'Tomasik', 'Affiliation': ""Department of Clinical Biochemistry, University Children's Hospital, Jagiellonian University Medical College, Cracow, Poland.""}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Kobylarz', 'Affiliation': ""Department of Anesthesiology and Intensive Care, University Children's Hospital, 265 Wielicka St, 30-663, Cracow, Poland.""}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'Wordliczek', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Jagiellonian University Medical College, Cracow, Poland.'}]",Pharmacological reports : PR,['10.1007/s43440-020-00100-7'] 108,31755090,Long-term safety and efficacy of lacosamide and controlled-release carbamazepine monotherapy in patients with newly diagnosed epilepsy.,"OBJECTIVE A large-scale, double-blind trial (SP0993; NCT01243177) demonstrated that lacosamide was noninferior to controlled-release carbamazepine (carbamazepine-CR) in terms of efficacy, and well tolerated as first-line monotherapy in patients (≥16 years of age) with newly diagnosed epilepsy. We report primary safety outcomes from the double-blind extension of the noninferiority trial (SP0994; NCT01465997) and post hoc analyses of pooled long-term safety and efficacy data from both trials. METHODS Patients were randomized 1:1 to lacosamide or carbamazepine-CR. Doses were escalated (lacosamide: 200/400/600 mg/d; carbamazepine-CR: 400/800/1200 mg/d) based on seizure control. Eligible patients continued randomized treatment in the extension. Primary outcomes of the extension were treatment-emergent adverse events (TEAEs), serious TEAEs, and discontinuations due to TEAEs. Post hoc analyses of data from combined trials included 12- and 24-month seizure freedom and TEAEs by number of comorbid conditions. RESULTS A total of 886 patients were treated in the initial trial and 548 in the extension; 211 of 279 patients (75.6%) on lacosamide and 180/269 (66.9%) on carbamazepine-CR completed the extension. In the extension, 181 patients (64.9%) on lacosamide and 182 (67.7%) on carbamazepine-CR reported TEAEs; in both groups, nasopharyngitis, headache, and dizziness were most common. Serious TEAEs were reported by 32 patients (11.5%) on lacosamide and 22 (8.2%) on carbamazepine-CR; 12 (4.3%) and 21 (7.8%) discontinued due to TEAEs. In the combined trials (median exposure: lacosamide 630 days; carbamazepine-CR 589 days), Kaplan-Meier estimated proportions of patients with 12- and 24-month seizure freedom from first dose were 50.8% (95% confidence interval 46.2%-55.4%) and 47.0% (42.2%-51.7%) on lacosamide, and 54.9% (50.3%-59.6%) and 50.9% (46.0%-55.7%) on carbamazepine-CR. Incidences of drug-related TEAEs and discontinuations due to TEAEs increased by number of comorbid conditions and were lower in patients on lacosamide. SIGNIFICANCE Long-term (median ~2 years) lacosamide monotherapy was efficacious and generally well tolerated in adults with newly diagnosed epilepsy. Seizure freedom rates were similar with lacosamide and carbamazepine-CR.",2019,"Incidences of drug-related TEAEs and discontinuations due to TEAEs increased by number of comorbid conditions and were lower in patients on lacosamide. ","['Patients', 'patients with newly diagnosed epilepsy', 'adults with newly diagnosed epilepsy', '886 patients were treated in the initial trial and 548 in the extension; 211 of 279 patients (75.6%) on lacosamide and 180/269 (66.9%) on carbamazepine-CR completed the extension', 'patients (≥16\xa0years of age) with newly diagnosed epilepsy', 'Long-term (median\xa0~2\xa0years']","['carbamazepine (carbamazepine-CR', 'Doses were escalated (lacosamide', 'carbamazepine-CR reported TEAEs', 'carbamazepine', 'carbamazepine-CR', 'lacosamide monotherapy', 'lacosamide and controlled-release carbamazepine monotherapy', 'lacosamide or carbamazepine-CR']","['Seizure\xa0freedom rates', 'nasopharyngitis, headache, and dizziness', 'extension were treatment-emergent adverse events (TEAEs), serious TEAEs, and discontinuations due to TEAEs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0893761', 'cui_str': 'lacosamide'}, {'cui': 'C0006949', 'cui_str': 'Carbamazepine'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]","[{'cui': 'C0006949', 'cui_str': 'Carbamazepine'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0893761', 'cui_str': 'lacosamide'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]","[{'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}]",886.0,0.265178,"Incidences of drug-related TEAEs and discontinuations due to TEAEs increased by number of comorbid conditions and were lower in patients on lacosamide. ","[{'ForeName': 'Elinor', 'Initials': 'E', 'LastName': 'Ben-Menachem', 'Affiliation': 'Institute for Clinical Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Hans Peter', 'Initials': 'HP', 'LastName': 'Grebe', 'Affiliation': 'Department of Neurology, Hospital São Sebastião, Centro Hospitalar de Entre o Douro e Vouga, Santa Maria da Feira, Portugal.'}, {'ForeName': 'Kiyohito', 'Initials': 'K', 'LastName': 'Terada', 'Affiliation': 'NHO Shizuoka Institute of Epilepsy and Neurological Disorders, Shizuoka, Japan.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Jensen', 'Affiliation': 'UCB Pharma, Raleigh, NC, USA.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'UCB Pharma, Raleigh, NC, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'De Backer', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Steiniger-Brach', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Gasalla', 'Affiliation': 'UCB Pharma, Raleigh, NC, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Brock', 'Affiliation': 'UCB Pharma, Raleigh, NC, USA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Biton', 'Affiliation': 'Arkansas Epilepsy Program, Clinical Trials Inc, Little Rock, AR, USA.'}]",Epilepsia,['10.1111/epi.16381'] 109,32304514,"Effects of 4, 8, and 12 Repetition Maximum Resistance Training Protocols on Muscle Volume and Strength.","ABSTRACT Kubo, K, Ikebukuro, T, and Yata, H. Effects of 4, 8, and 12 repetition maximum resistance training protocols on muscle volume and strength. J Strength Cond Res 35(4): 879-885, 2021-The purpose of this study was to determine skeletal muscle adaptations (strength and hypertrophy) in response to volume-equated resistance training with divergent repetition strategies. Forty-two men were randomly assigned to 4 groups: higher load-lower repetition group performing 4 repetition maximum (RM) for 7 sets (4RM, n = 10), intermediate load-intermediate repetition group performing 8RM for 4 sets (8RM, n = 12), lower load-higher repetition group performing 12RM for 3 sets (12RM, n = 10), and nonexercising control group (CON, n = 10). The volume of the pectoralis major muscle (by magnetic resonance imaging) and 1RM of the bench press were measured before and after 10 weeks of training (2 times per week). No significant difference was observed in the relative increase in the muscle volume among the 4RM, 8RM, and 12RM groups. The relative increase in 1RM was significantly lower in the 12RM group than in the 4RM group (p = 0.029) and the 8RM group (p = 0.021). The relative increase in 1RM was significantly correlated with that in the muscle volume in the 12RM group (r = 0.684, p = 0.042), but not in the 4RM (r = -0.265, p = 0.777) or 8RM (r = -0.045, p = 0.889) groups. These results suggest that the increase in muscle size is similar among the 3 training protocols when the training volume was equated, whereas the increase in muscle strength is lower with the 12RM protocol than the other protocols.",2021,"No significant difference was observed in the relative increase in the muscle volume among the 4RM, 8RM, and 12RM groups.",['Forty-two men'],"['nonexercising control', 'higher load-lower repetition group performing 4 repetition maximum (RM) for 7 sets (4RM, n = 10), intermediate load-intermediate repetition group performing 8RM for 4 sets (8RM, n = 12), lower load-higher repetition group performing 12RM', 'J Strength Cond Res XX(X']","['muscle volume', 'muscle strength', 'Muscle Volume and Strength', 'muscle size', '1RM', 'relative increase in 1RM', 'skeletal muscle adaptations (strength and hypertrophy', 'muscle volume and strength']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}]",42.0,0.0130384,"No significant difference was observed in the relative increase in the muscle volume among the 4RM, 8RM, and 12RM groups.","[{'ForeName': 'Keitaro', 'Initials': 'K', 'LastName': 'Kubo', 'Affiliation': 'Department of Life Science (Sports Sciences), the University of Tokyo, Tokyo, Japan; and.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Ikebukuro', 'Affiliation': 'Department of Life Science (Sports Sciences), the University of Tokyo, Tokyo, Japan; and.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Yata', 'Affiliation': 'Department of Human and Environmental Well-being, Wako University, Tokyo, Japan.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003575'] 110,32273563,A Randomised Control Trial and Comparative Analysis of Multi-Dimensional Learning Tools in Anatomy.,"This article presents the results of a study that examined students' ability to retain what they have learned in an anatomy course after thirty days via using various learning tools for twenty minutes. Fifty-two second-year medical students were randomly assigned to three learning tools: text-only, three-dimension visualisation in a two-dimensional screen (3DM), or mixed reality (MR). An anatomy test lasting for twenty minutes measuring spatial and nominal knowledge was taken immediately after the learning intervention and another thirty days later. Psychometric tests were also used to measure participants' memory, reasoning and concentration abilities. Additionally, electroencephalogram data was captured to measure the participants' awakeness during the learning session. Results of this study showed that the MR group performed poorly in the nominal questions compared to the other groups; however, the MR group demonstrated higher retention in both the nominal and spatial type information for at least a month compared to the other groups. Furthermore, participants in the 3DM and MR groups reported increased engagement. The results of this study suggest that three-dimensional visualiser tools are likely to enhance learning in anatomy education. However, the study itself has several limitations; some include limited sample size and various threats to internal validity.",2020,"Results of this study showed that the MR group performed poorly in the nominal questions compared to the other groups; however, the MR group demonstrated higher retention in both the nominal and spatial type information for at least a month compared to the other groups.",['Fifty-two second-year medical students'],"['learning tools: text-only, three-dimension visualisation in a two-dimensional screen (3DM), or mixed reality (MR']","[""participants' memory, reasoning and concentration abilities""]","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C5197824', 'cui_str': 'Mixed Reality'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0424098', 'cui_str': 'Ability to concentrate'}]",,0.0188912,"Results of this study showed that the MR group performed poorly in the nominal questions compared to the other groups; however, the MR group demonstrated higher retention in both the nominal and spatial type information for at least a month compared to the other groups.","[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Anatomy, School of Biomedical Sciences, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Ben Kei', 'Initials': 'BK', 'LastName': 'Daniel', 'Affiliation': 'Education Technology Group, Higher Education Development Centre, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Asil', 'Affiliation': 'Centre for Healthcare Education and Research Innovation (CHERI), School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Prashanna', 'Initials': 'P', 'LastName': 'Khwaounjoo', 'Affiliation': 'Department of Anatomy, School of Biomedical Sciences, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Yusuf Ozgur', 'Initials': 'YO', 'LastName': 'Cakmak', 'Affiliation': 'Department of Anatomy, School of Biomedical Sciences, University of Otago, Dunedin, New Zealand. yusuf.cakmak@otago.ac.nz.'}]",Scientific reports,['10.1038/s41598-020-62855-6'] 111,32277134,Efficacy of Ultrasound-guided Radiofrequency Ablation of Parathyroid Hyperplasia: Single Session vs. Two-Session for Effect on Hypocalcemia.,"To evaluate safety and efficacy of one- vs. two-session radiofrequency ablation (RFA) of parathyroid hyperplasia for patients with secondary hyperparathyroidism (SHPT) and to compare the outcome of both methods on hypocalcemia. Patients with secondary hyperparathyroidism underwent ultrasound guided RFA of parathyroid hyperplasia. Patients were alternately assigned to either group 1 (n = 28) with RFA of all 4 glands in one session or group 2 (n = 28) with RFA of 2 glands in a first session and other 2 glands in a second session. Serum parathyroid hormone (PTH), calcium, phosphorus and alkaline phosphatase (ALP) values were measured at a series of time points after RFA. RFA parameters, including operation duration and ablation time and hospitalization length and cost, were compared between the two groups. Mean PTH decreased in group 1 from 1865.18 ± 828.93 pg/ml to 145.72 ± 119.27 pg/ml at 1 day after RFA and in group 2 from 2256.64 ± 1021.72 pg/ml to 1388.13 ± 890.15 pg/ml at 1 day after first RFA and to 137.26 ± 107.12 pg/ml at 1 day after second RFA. Group 1's calcium level decreased to 1.79 ± 0.31 mmol/L at day 1 after RFA and group 2 decreased to 1.89 ± 0.26 mmol/L at day 1 after second session RFA (P < 0.05). Multivariate analysis showed that hypocalcemia was related to serum ALP. Patients with ALP ≥ 566 U/L had lower calcium compared to patients with ALP < 566 U/L up to a month after RFA (P < 0.05). Group 1's RFA time and hospitalization were shorter and had lower cost compared with Group 2. US-guided RFA of parathyroid hyperplasia is a safe and effective method for treating secondary hyperparathyroidism. Single-session RFA was more cost-effective and resulted in a shorter hospital stay compared to two sessions. However, patients with two-session RFA had less hypocalcemia, especially those with high ALP.",2020,Mean PTH decreased in group 1 from 1865.18 ± 828.93 pg/ml to 145.72 ± 119.27 pg/ml at 1 day after RFA and in group 2 from 2256.64 ± 1021.72 pg/ml to 1388.13 ± 890.15 pg/ml at 1 day after first RFA and to 137.26 ± 107.12 pg/ml at 1 day after second RFA.,"['Patients with ALP\u2009≥', 'patients with secondary hyperparathyroidism (SHPT', 'Patients with secondary hyperparathyroidism underwent ultrasound guided RFA of parathyroid hyperplasia']","['one- vs. two-session radiofrequency ablation (RFA', 'RFA of all 4 glands in one session or group 2 (n\u2009=\u200928) with RFA of 2 glands in a first session and other 2 glands in a second session', 'parathyroid hyperplasia', 'Ultrasound-guided Radiofrequency Ablation']","['Serum parathyroid hormone (PTH), calcium, phosphorus and alkaline phosphatase (ALP) values', 'calcium level', 'shorter hospital stay', 'safety and efficacy', 'hypocalcemia', 'RFA time and hospitalization', 'RFA parameters, including operation duration and ablation time and hospitalization length and cost', 'Hypocalcemia', 'Mean PTH']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0020503', 'cui_str': 'Secondary hyperparathyroidism'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0271844', 'cui_str': 'Parathyroid hyperplasia'}]","[{'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C1285092', 'cui_str': 'Gland structure'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0271844', 'cui_str': 'Parathyroid hyperplasia'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0428408', 'cui_str': 'Serum parathyroid hormone measurement'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0201925', 'cui_str': 'Calcium measurement'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}]",,0.0252517,Mean PTH decreased in group 1 from 1865.18 ± 828.93 pg/ml to 145.72 ± 119.27 pg/ml at 1 day after RFA and in group 2 from 2256.64 ± 1021.72 pg/ml to 1388.13 ± 890.15 pg/ml at 1 day after first RFA and to 137.26 ± 107.12 pg/ml at 1 day after second RFA.,"[{'ForeName': 'Zeng', 'Initials': 'Z', 'LastName': 'Zeng', 'Affiliation': ""Department of Ultrasound, Zhejiang Provincial People's Hospital, Hangzhou Medical College, Hangzhou, Zhejiang, China.""}, {'ForeName': 'Cheng-Zhong', 'Initials': 'CZ', 'LastName': 'Peng', 'Affiliation': ""Department of Ultrasound, Zhejiang Provincial People's Hospital, Hangzhou Medical College, Hangzhou, Zhejiang, China. pcz001@126.com.""}, {'ForeName': 'Ji-Bin', 'Initials': 'JB', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, Thomas Jefferson University Hospital, Philadelphia, USA.'}, {'ForeName': 'Yi-Wen', 'Initials': 'YW', 'LastName': 'Li', 'Affiliation': ""Department of Nephrology, Zhejiang Provincial People's Hospital, Hangzhou Medical College, Hangzhou, Zhejiang, China.""}, {'ForeName': 'Hong-Feng', 'Initials': 'HF', 'LastName': 'He', 'Affiliation': ""Department of Ultrasound, Zhejiang Provincial People's Hospital, Hangzhou Medical College, Hangzhou, Zhejiang, China.""}, {'ForeName': 'Qiao-Hong', 'Initials': 'QH', 'LastName': 'Hu', 'Affiliation': ""Department of Ultrasound, Zhejiang Provincial People's Hospital, Hangzhou Medical College, Hangzhou, Zhejiang, China.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Lin', 'Affiliation': ""Department of Nephrology, Zhejiang Provincial People's Hospital, Hangzhou Medical College, Hangzhou, Zhejiang, China.""}, {'ForeName': 'Xiao-Gang', 'Initials': 'XG', 'LastName': 'Shen', 'Affiliation': ""Department of Nephrology, Zhejiang Provincial People's Hospital, Hangzhou Medical College, Hangzhou, Zhejiang, China.""}]",Scientific reports,['10.1038/s41598-020-63299-8'] 112,32275788,Omega-3 fatty acid supplementation for cystic fibrosis.,"BACKGROUND Studies suggest that a diet rich in omega-3 essential fatty acids may have beneficial anti-inflammatory effects for chronic conditions such as cystic fibrosis. This is an updated version of a previously published review. OBJECTIVES To determine whether there is evidence that omega-3 polyunsaturated fatty acid supplementation reduces morbidity and mortality and to identify any adverse events associated with supplementation. SEARCH METHODS We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. Date of last search: 01 April 2020. We also searched online study registries and contacted authors. Date of last search: 12 February 2020. SELECTION CRITERIA Randomised controlled trials in people with cystic fibrosis comparing omega-3 fatty acid supplements with placebo. DATA COLLECTION AND ANALYSIS Two authors independently selected studies for inclusion, extracted data and assessed the risk of bias of the studies. The quality of the evidence was assessed using GRADE. MAIN RESULTS The searches identified 23 studies; five studies with 106 participants (children and adults) were included; duration of studies and interventions differed. Two studies compared omega-3 fatty acids to olive oil for six weeks; one study compared omega-3 fatty acids and omega-6 fatty acids to control capsules (customised fatty acid blends) for three months; one study compared a liquid dietary supplement containing omega-3 fatty acids to one without for six months; and one study compared omega-3 fatty acids to a placebo for 12 months. Three studies had a low risk of bias for randomisation, but the risk was unclear in the remaining two studies; all studies had an unclear risk of bias for allocation concealment. Three of the studies adequately blinded participants; the risk of bias for selective reporting was high in one study and unclear for four studies. Two studies reported the number of respiratory exacerbations. At three months, one study (43 participants) reported no change in antibiotic usage. At 12 months the second study (15 participants) reported a reduction in the number of pulmonary exacerbations and cumulative antibiotic days in the supplement group compared to the previous year (no data for the control group); very low-quality evidence means we are unsure whether supplementation has any effect on this outcome. With regards to adverse events, one six-week study (12 participants) reported no difference in diarrhoea between omega-3 or placebo capsules; the very low-quality evidence means we are unsure if supplementation has any effect on this outcome. Additionally, one study reported an increase in steatorrhoea requiring participants to increase their daily dose of pancreatic enzymes, but three studies had already increased pancreatic enzyme dose at study begin so as to reduce the incidence of steatorrhoea. One study (43 participants) reported stomach pains at three months (treatment or control group not specified). One six-week study (19 participants) reported three asthma exacerbations leading to exclusion of participants since corticosteroid treatment could affect affect essential fatty acid metabolism. Four studies reported lung function. One six-week study (19 participants) reported an increase in forced expiratory volume in one second (FEV 1 ) (L) and forced vital capacity (FVC) (L), but the very low-quality evidence means we are unsure if supplementation has any effect on lung function. The remaining studies did not report any difference in lung function at three months (unit of measurement not specified) or at six months and one year (FEV 1 % predicted and FVC % predicted). No deaths were reported in any of the five studies. Four studies reported clinical variables. One study reported an increase in Schwachman score and weight alongside a reduction in sputum volume with supplementation compared to placebo at three months (data not analysable). However, three studies reported no differences in either weight at six weeks, in body mass index (BMI) standard deviation (SD) score at six months (very low-quality evidence) or BMI Z score at 12 months. Three studies reported biochemical markers of fatty acid status. One study showed an increase from baseline in both EPA and DHA content of serum phospholipids in the omega-3 group compared to placebo at three months and also a significant decrease in n-6/n-3 ratio in the supplement group compared to placebo; since the quality of the evidence is very low we are not certain that these changes are due to supplementation. One six-month cross-over study showed a higher EPA content of the neutrophil membrane in the supplement group compared to the placebo group, but, no difference in DHA membrane concentration. Furthermore, the leukotriene B 4 to leukotriene B 5 ratio was lower at six months in the omega-3 group compared to placebo. A one-year study reported a greater increase in the essential fatty acid profile and a decrease in AA levels in the treatment arm compared to placebo. AUTHORS' CONCLUSIONS This review found that regular omega-3 supplements may provide some limited benefits for people with cystic fibrosis with relatively few adverse effects: however, the quality of the evidence across all outcomes was very low. The current evidence is insufficient to draw firm conclusions or recommend routine use of these supplements in people with cystic fibrosis. A large, long-term, multicentre, randomised controlled study is needed to determine any significant therapeutic effect and to assess the influence of disease severity, dosage and duration of treatment. Future researchers should note the need for additional pancreatic enzymes when providing omega-3 supplementation or olive oil placebo capsules. More research is required to determine the exact dose of pancreatic enzyme required.",2020,At 12 months the second study (15 participants) reported a reduction in the number of pulmonary exacerbations and cumulative antibiotic days in the supplement group compared to the previous year (no data for the control group); very low-quality evidence means we are unsure whether supplementation has any effect on this outcome.,"['people with cystic fibrosis comparing', 'people with cystic fibrosis', 'cystic fibrosis', '106 participants (children and adults']","['omega-3 fatty acids and omega-6 fatty acids to control capsules (customised fatty acid blends', 'omega-3 fatty acids to a placebo', 'regular omega-3 supplements', 'omega-3 fatty acid supplements with placebo', 'omega-3 fatty acids to olive oil', 'placebo', 'omega-3 polyunsaturated fatty acid supplementation', 'liquid dietary supplement containing omega-3 fatty acids', 'Omega-3 fatty acid supplementation']","['diarrhoea', 'essential fatty acid metabolism', 'morbidity and mortality', 'antibiotic usage', 'Schwachman score and weight alongside a reduction in sputum volume', 'BMI Z score', 'EPA content of the neutrophil membrane', 'number of respiratory exacerbations', 'EPA and DHA content of serum phospholipids', 'essential fatty acid profile', 'lung function', 'n-6/n-3 ratio', 'body mass index (BMI) standard deviation (SD) score', 'number of pulmonary exacerbations and cumulative antibiotic days', 'AA levels', 'stomach pains', 'forced expiratory volume in one second (FEV 1 ) (L) and forced vital capacity (FVC) (L', 'DHA membrane concentration']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0133860', 'cui_str': 'Fatty Acids, Omega-6'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015686', 'cui_str': 'Fatty Acids, Essential'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0425514', 'cui_str': 'Sputum volume'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031676', 'cui_str': 'Phospholipids'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",43.0,0.265456,At 12 months the second study (15 participants) reported a reduction in the number of pulmonary exacerbations and cumulative antibiotic days in the supplement group compared to the previous year (no data for the control group); very low-quality evidence means we are unsure whether supplementation has any effect on this outcome.,"[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Watson', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Addenbrookes Hospital, Cambridge Biomedical Campus, Hills Road, Cambridge, UK, CB2 0QQ.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Stackhouse', 'Affiliation': 'Royal Papworth Hospital NHS Foundation Trust, Dietetics and Speech and Language Therapy, Papworth Road, Cambridge Biomedical Campus, Cambridge, UK, CB2 0AY.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD002201.pub6'] 113,31958178,Mild acute cellular rejection and development of cardiac allograft vasculopathy assessed by intravascular ultrasound and coronary angiography in heart transplant recipients-a SCHEDULE trial substudy.,"To evaluate the association between mild acute cellular rejection (ACR) and the development of cardiac allograft vasculopathy (CAV) after heart transplantation (HTx). Substudy of the SCHEDULE trial (n = 115), where de novo HTx recipients were randomized to (i) everolimus with early CNI elimination or (ii) CNI-based immunosuppression. Seventy-six patients (66%) were included based on matched intravascular ultrasound (IVUS) examinations at baseline and year 3 post-HTx. Biopsy-proven ACR within year 1 post-HTx was recorded and graded (1R, 2R, 3R). Development of CAV was assessed by IVUS and coronary angiography at year 3 post-HTx. Median age was 53 years (45-61), and 71% were male. ACR was recorded in 67%, and patients were grouped by rejection profile: no ACR (33%), only 1R (42%), and ≥2R (25%). Median ∆MIT (maximal intimal thickness) BL-3Y was not significantly different between groups (P = 0.84). The incidence of CAV was 49% by IVUS and 26% by coronary angiography with no significant differences between groups. No correlation was found between number of 1R and ∆MIT BL-3Y (r = -0.025, P = 0.83). The number of 1R was not a significant predictor of ∆MIT BL-3Y (P = 0.58), and no significant interaction with treatment was found (P = 0.98). The burden of mild ACR was not associated with CAV development.",2020,"Number of 1R was not a significant predictor of ∆MIT BL-3Y (p=0.58) and no significant interaction with treatment was found (p=0.98). ","['Substudy of the SCHEDULE trial (n=115), where de novo HTx recipients', 'heart transplant recipients ', 'Median age was 53 years (45-61) and 71% were male', '76 patients (66%) were included based on matched intravascular ultrasound (IVUS) examinations at baseline and year 3 post-HTx']","['everolimus with early CNI elimination or (ii) CNI-based immunosuppression', 'intravascular ultrasound and coronary angiography']","['BL-3Y', 'Median ∆MIT(maximal intimal thickness', 'incidence of CAV', 'ACR', '∆MIT BL-3Y', 'number of 1R and ∆MIT BL-3Y', 'burden of mild ACR']","[{'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C2029943', 'cui_str': 'Transplanted heart present'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0442123', 'cui_str': 'Intravascular (qualifier value)'}, {'cui': 'C0948501', 'cui_str': 'Ultrasound examination'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0021080', 'cui_str': 'Immunosuppression (Physiology)'}, {'cui': 'C0442123', 'cui_str': 'Intravascular (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0206179', 'cui_str': 'Chicken Anemia Agent'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}]",76.0,0.0325031,"Number of 1R was not a significant predictor of ∆MIT BL-3Y (p=0.58) and no significant interaction with treatment was found (p=0.98). ","[{'ForeName': 'Laerke Marie', 'Initials': 'LM', 'LastName': 'Nelson', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Arne Kristian', 'Initials': 'AK', 'LastName': 'Andreassen', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Satish', 'Initials': 'S', 'LastName': 'Arora', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Andersson', 'Affiliation': 'Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Einar', 'Initials': 'E', 'LastName': 'Gude', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Eiskjaer', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Göran', 'Initials': 'G', 'LastName': 'Rådegran', 'Affiliation': 'The Section for Heart Failure and Valvular Disease, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Göran', 'Initials': 'G', 'LastName': 'Dellgren', 'Affiliation': 'Transplant Institute, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Gullestad', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}]",Transplant international : official journal of the European Society for Organ Transplantation,['10.1111/tri.13577'] 114,31595302,"Oxytocin Enhances an Amygdala Circuit Associated With Negative Symptoms in Schizophrenia: A Single-Dose, Placebo-Controlled, Crossover, Randomized Control Trial.","Negative symptoms are core contributors to vocational and social deficits in schizophrenia (SZ). Available antipsychotic medications typically fail to reduce these symptoms. The neurohormone oxytocin (OT) is a promising treatment for negative symptoms, given its role in complex social behaviors mediated by the amygdala. In sample 1, we used a double-blind, placebo-controlled, crossover design to test the effects of a single dose of intranasal OT on amygdala resting-state functional connectivity (rsFC) in SZ (n = 22) and healthy controls (HC, n = 24) using a whole-brain corrected approach: we identified regions for which OT modulated SZ amygdala rsFC, assessed whether OT-modulated circuits were abnormal in SZ relative to HC on placebo, and evaluated whether connectivity on placebo and OT-induced connectivity changes correlated with baseline negative symptoms in SZ. Given our modest sample size, we used a second SZ (n = 183) and HC (n = 178) sample to replicate any symptom correlations. In sample 1, OT increased rsFC between the amygdala and left middle temporal gyrus, superior temporal sulcus, and angular gyrus (MTG/STS/AngG) in SZ compared to HC. Further, SZ had hypo-connectivity in this circuit compared to HC on placebo. More severe negative symptoms correlated with less amygdala-to-left-MTG/STS/AngG connectivity on placebo and with greater OT-induced connectivity increases. In sample 2, we replicated the correlation between amygdala-left-MTG/STS/AngG hypo-connectivity and negative symptoms, finding a specific association with expressive negative symptoms. These data suggest intranasal OT can normalize functional connectivity in an amygdala-to-left-MTG/STS/AngG circuit that contributes to negative symptoms in SZ.",2020,More severe negative symptoms correlated with less amygdala-to-left-MTG/STS/AngG connectivity on placebo and with greater OT-induced connectivity increases.,"['SZ (n = 22) and healthy controls (HC, n = 24', 'Schizophrenia']","['Placebo', 'SZ', 'placebo', 'intranasal OT', 'Oxytocin', 'neurohormone oxytocin (OT']","['hypo-connectivity', 'severe negative symptoms', 'amygdala resting-state functional connectivity (rsFC']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0597049', 'cui_str': 'Neurohormones'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",,0.133066,More severe negative symptoms correlated with less amygdala-to-left-MTG/STS/AngG connectivity on placebo and with greater OT-induced connectivity increases.,"[{'ForeName': 'Samantha V', 'Initials': 'SV', 'LastName': 'Abram', 'Affiliation': 'Sierra Pacific Mental Illness Research Education and Clinical Centers, San Francisco VA Medical Center, and the University of California, San Francisco, CA.'}, {'ForeName': 'Lize', 'Initials': 'L', 'LastName': 'De Coster', 'Affiliation': 'Department of Computer Science, Universidad Carlos III de Madrid, Madrid, Spain.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Roach', 'Affiliation': 'Mental Health Service, San Francisco Veterans Affairs Medical Center, San Francisco, CA.'}, {'ForeName': 'Bryon A', 'Initials': 'BA', 'LastName': 'Mueller', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Theo G M', 'Initials': 'TGM', 'LastName': 'van Erp', 'Affiliation': 'Clinical Translational Neuroscience Laboratory, Department of Psychiatry and Human Behavior, University of California Irvine, Irvine, CA, USA.'}, {'ForeName': 'Vince D', 'Initials': 'VD', 'LastName': 'Calhoun', 'Affiliation': 'The Mind Research Network, Albuquerque, NM.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Preda', 'Affiliation': 'Department of Psychiatry and Human Behavior, University of California Irvine, Irvine, CA, USA.'}, {'ForeName': 'Kelvin O', 'Initials': 'KO', 'LastName': 'Lim', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Turner', 'Affiliation': 'Department of Psychology, Georgia State University, Atlanta, GA.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Ford', 'Affiliation': 'Mental Health Service, San Francisco Veterans Affairs Medical Center, San Francisco, CA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Mathalon', 'Affiliation': 'Mental Health Service, San Francisco Veterans Affairs Medical Center, San Francisco, CA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Woolley', 'Affiliation': 'Mental Health Service, San Francisco Veterans Affairs Medical Center, San Francisco, CA.'}]",Schizophrenia bulletin,['10.1093/schbul/sbz091'] 115,32294560,"Efficacy of lidocaine 7 %, tetracaine 7 % self-occlusive cream in reducing MAL-cPDT-associated pain in subjects with actinic keratosis: A randomized, single-blind, vehicle-controlled trial (The ""3P-Trial"").","INTRODUCTION Conventional photodynamic therapy (cPDT) is considered a very effective treatment of actinic keratosis (AK) lesions. However, its use is limited by the fact that this procedure could be very painful. The use of topical anesthetics such as tetracaine or lignocaine/prilocaine has shown disappointing results in term of pain reduction. A self-occlusive topical 7% lidocaine/7% tetracaine anesthetic cream (LT-C) approved by the FDA to provide local topical anesthesia in adults undergoing superficial dermatological procedures is available. There are no data regarding its pain reducing effect during cPDT. We perform a prospective, randomized, single-blind, two-center trial (The 3P-Trial) to assess the pain reduction effect of LT-C versus vehicle in subjects with AK undergoing cPDT. MATERIAL AND METHODS Fifty AK subjects (74 ± 10 years, 32 men, 18 women) with on average 17 lesions were enrolled after their written informed consent. Eight subjects presented also a total of 16 basal cell carcinoma lesions. Twenty-five were randomized to LT-cream, applied 1 h before the Methyl amino levulinate (MAL)-cPDT session and 25 to cream vehicle. The main outcome was the patient-assessed evaluation of pain score during and just after the conclusion of cPDT session (mean of the two values) using a 10-point visual analog scale (VAS). The cPDT session (LED Red light 630 nm) was performed with a duration of 6 ± 2 min with a standard fluence of 37 J/cm2. All treated lesions were prepared by gentle superficial curettage. RESULTS All the randomized subjects concluded the trial. The mean ± SD of VAS score in vehicle group was 6.2 ± 2.7 (95 % CI of the mean: 5.0-7.5). In the group treated with LT-cream the VAS score was 3.3 ± 1.9 (95 % CI of the mean: 2.5-4.1). The active cream reduced the VAS score by 47 %. Median values of pain VAS score in the active group was reduced by 60 % in comparison with vehicle group (3.0 vs 7.5). The difference between the two groups was statistically significant (p = 0.0009; Mann-Whitney test). DISCUSSION The 3P-trial has demonstrated that the preventive application of the self-occlusive lidocaine 7%-tetracaine 7% cream is very effective in reducing the procedure-associated pain during MAL-cPDT for the treatment of AK lesions.",2020,"The difference between the two groups was statistically significant (p = 0.0009; Mann-Whitney test). ","['subjects with actinic keratosis', 'actinic keratosis (AK) lesions', 'Eight subjects presented also a total of 16 basal cell carcinoma lesions', 'Fifty AK subjects (74\u2009±\u200910 years, 32 men, 18 women) with on average 17 lesions were enrolled after their written informed consent', 'Twenty-five were randomized to', 'subjects with AK undergoing cPDT', 'adults undergoing superficial dermatological procedures']","['lidocaine', 'tetracaine or lignocaine/prilocaine', 'lidocaine 7%-tetracaine', 'LT-C versus vehicle', 'LT-cream, applied 1\u2009hour before the Methyl amino levulinate (MAL)-cPDT session and 25 to cream vehicle', 'tetracaine', 'lidocaine/7% tetracaine anesthetic cream (LT-C', 'Conventional photodynamic therapy (cPDT']","['10-point visual analog scale (VAS', 'Median values of pain VAS score', 'VAS score', 'patient-assessed evaluation of pain score', 'pain reduction effect', 'MAL-cPDT-associated pain', 'mean\u2009±\u2009SD of VAS score']","[{'cui': 'C0022602', 'cui_str': 'Actinic keratosis'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007117', 'cui_str': 'Basal cell carcinoma'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0011625', 'cui_str': 'DERMATOLOGICALS'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0039629', 'cui_str': 'Tetracaine'}, {'cui': 'C0033124', 'cui_str': 'Prilocaine'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C3505266', 'cui_str': 'levulinate'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C3505266', 'cui_str': 'levulinate'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",50.0,0.0858632,"The difference between the two groups was statistically significant (p = 0.0009; Mann-Whitney test). ","[{'ForeName': 'Marta Benedetta', 'Initials': 'MB', 'LastName': 'Brumana', 'Affiliation': 'Humanitas San Pio X Clinic, Milan, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Milani', 'Affiliation': 'Cantabria Labs Difa Cooper Medical Direction, Viale Milano 160, Caronno Pertusella, VA, Italy. Electronic address: massimo.milani@difacooper.com.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Puviani', 'Affiliation': 'Dermatology Medica Plus, Modena, Italy.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101758'] 116,31965579,Multicenter Validation of Association Between Decline in MRI-PDFF and Histologic Response in NASH.,"BACKGROUND AND AIMS Emerging data from a single-center study suggests that a 30% relative reduction in liver fat content as assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) from baseline may be associated with histologic improvement in nonalcoholic steatohepatitis (NASH). There are limited multicenter data comparing an active drug versus placebo on the association between the quantity of liver fat reduction assessed by MRI-PDFF and histologic response in NASH. This study aims to examine the association between 30% relative reduction in MRI-PDFF and histologic response in obeticholic acid (OCA) versus placebo-treated patients in the FLINT (farnesoid X receptor ligand obeticholic acid in NASH trial). APPROACH AND RESULTS This is a secondary analysis of the FLINT trial including 78 patients with MRI-PDFF measured before and after treatment along with paired liver histology assessment. Histologic response was defined as a 2-point improvement in nonalcoholic fatty liver disease activity score without worsening of fibrosis. OCA (25 mg orally once daily) was better than placebo in improving MRI-PDFF by an absolute difference of -3.4% (95% confidence interval [CI], -6.5 to -0.2%, P value = 0.04) and relative difference of -17% (95% CI, -34 to 0%, P value = 0.05). The optimal cutoff point for relative decline in MRI-PDFF for histologic response was 30% (using Youden's index). The rate of histologic response in those who achieved less than 30% decline in MRI-PDFF versus those who achieved a 30% or greater decline in MRI-PDFF (MRI-PDFF responders) relative to baseline was 19% versus 50%, respectively. Compared with MRI-PDFF nonresponders, MRI-PDFF responders demonstrated both a statistically and clinically significant higher odds 4.86 (95% CI, 1.4-12.8, P value < 0.009) of histologic response, including significant improvements in both steatosis and ballooning. CONCLUSION OCA was better than placebo in reducing liver fat. This multicenter trial provides data regarding the association between 30% decline in MRI-PDFF relative to baseline and histologic response in NASH.",2020,"Compared to MRI-PDFF non-responders, MRI-PDFF responders demonstrated both a statistically and clinically significant higher odds 4.86 (95% CI, 1.4-12.8, p-value <0.009) of histologic response including significant improvements in both steatosis and ballooning. ","['treated patients in the FLINT trial', 'nonalcoholic steatohepatitis', '78 patients with MRI-PDFF measured before and after treatment along with paired liver histology assessment']","['placebo', 'obeticholic acid versus placebo', 'Obeticholic acid']","['Histologic response', 'MRI-PDFF', 'NAFLD Activity Score', 'MRI-PDFF and histologic response', 'rate of histologic response']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0303753', 'cui_str': 'Flintstone'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic Steatohepatitis'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1143018', 'cui_str': 'obeticholic acid'}]","[{'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",78.0,0.29775,"Compared to MRI-PDFF non-responders, MRI-PDFF responders demonstrated both a statistically and clinically significant higher odds 4.86 (95% CI, 1.4-12.8, p-value <0.009) of histologic response including significant improvements in both steatosis and ballooning. ","[{'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Loomba', 'Affiliation': 'NAFLD Research Center, Division of Gastroenterology and Hepatology Department of Medicine, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Brent A', 'Initials': 'BA', 'LastName': 'Neuschwander-Tetri', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Saint Louis University, St. Louis, MO.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Sanyal', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Department of Medicine, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Naga', 'Initials': 'N', 'LastName': 'Chalasani', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Indiana University, Indianapolis, IN.'}, {'ForeName': 'Anna Mae', 'Initials': 'AM', 'LastName': 'Diehl', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Duke University, Durham, NC.'}, {'ForeName': 'Norah', 'Initials': 'N', 'LastName': 'Terrault', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Kowdley', 'Affiliation': 'Liver Center, Department of Medicine, Swedish Medical Center, Seattle, WA.'}, {'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Dasarathy', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kleiner', 'Affiliation': 'Laboratory of Pathology, The National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Behling', 'Affiliation': 'NAFLD Research Center, Division of Gastroenterology and Hepatology Department of Medicine, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Lavine', 'Affiliation': 'Division of Gastroenterology, Department of Pediatrics, Columbia University, New York, NY.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Van Natta', 'Affiliation': 'Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Middleton', 'Affiliation': 'NAFLD Research Center, Division of Gastroenterology and Hepatology Department of Medicine, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tonascia', 'Affiliation': 'Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Sirlin', 'Affiliation': 'NAFLD Research Center, Division of Gastroenterology and Hepatology Department of Medicine, University of California San Diego, La Jolla, CA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Hepatology (Baltimore, Md.)",['10.1002/hep.31121'] 117,31751466,Dopamine-Induced Dysconnectivity Between Salience Network and Auditory Cortex in Subjects With Psychotic-like Experiences: A Randomized Double-Blind Placebo-Controlled Study.,"Dopamine is involved in the pathophysiology of schizophrenia. Disrupted salience processing by the salience network (SN) may be a central link between dysregulated dopamine function and psychotic symptoms. However, dopaminergic influence on the SN and its presumed influence on psychotic and subpsychotic symptoms or psychotic-like experiences in healthy individuals remain unclear. Therefore, we investigated dopamine-induced changes in functional connectivity of the right anterior insula (rAI), a central SN hub, and their association with psychotic-like experiences. We enrolled 54 healthy, right-handed male subjects in a randomized, double-blind, cross-sectional placebo-controlled experiment. Psychotic-like experiences were assessed using the revised Exceptional Experiences Questionnaire (PAGE-R). They then received either placebo (n = 32) or 200 mg L-DOPA (n = 33), a dopamine precursor, orally and underwent resting-state functional magnetic resonance imaging. In a seed-to-voxel approach, we analyzed dopamine-induced changes in functional connectivity of the rAI and assessed the relationship between functional connectivity changes and PAGE-R score. L-DOPA reduced functional connectivity between the rAI and the left auditory cortex planum polare. In the placebo group, we found a strong negative correlation between PAGE-R score and rAI to planum polare functional connectivity; in the L-DOPA group, there was a strong positive correlation between PAGE-R score and functional connectivity between rAI and planum polare. The PAGE-R score explained about 30% of the functional connectivity variation between rAI and planum polare in the two groups. Our findings suggest that psychotic-like experiences are associated with dopamine-induced disruption of auditory input to the SN, which may lead to aberrant attribution of salience.",2020,L-DOPA reduced functional connectivity between the rAI and the left auditory cortex planum polare.,"['54 healthy, right-handed male subjects', 'Subjects With Psychotic-like Experiences']","['Dopamine-Induced Dysconnectivity Between Salience Network and Auditory Cortex', 'Placebo', 'placebo', 'Dopamine', 'dopamine precursor, orally and underwent resting-state functional magnetic resonance imaging']","['PAGE-R score and rAI to planum polare functional connectivity', 'Psychotic-like experiences', 'PAGE-R score and functional connectivity', 'functional connectivity']","[{'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}]","[{'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0004302', 'cui_str': 'Temporal Auditory Area'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3498719', 'cui_str': 'Planum Polare'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}]",54.0,0.185893,L-DOPA reduced functional connectivity between the rAI and the left auditory cortex planum polare.,"[{'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Rössler', 'Affiliation': 'Collegium Helveticum, University of Zurich and ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Wulf', 'Initials': 'W', 'LastName': 'Rössler', 'Affiliation': 'Collegium Helveticum, University of Zurich and ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Seifritz', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Lui', 'Initials': 'L', 'LastName': 'Unterrassner', 'Affiliation': 'Collegium Helveticum, University of Zurich and ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wyss', 'Affiliation': 'Collegium Helveticum, University of Zurich and ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Haker', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Wotruba', 'Affiliation': 'Collegium Helveticum, University of Zurich and ETH Zurich, Zurich, Switzerland.'}]",Schizophrenia bulletin,['10.1093/schbul/sbz110'] 118,31206358,Association of Elevated Plasma Interleukin-18 Level With Increased Mortality in a Clinical Trial of Statin Treatment for Acute Respiratory Distress Syndrome.,"OBJECTIVE A high plasma level of inflammasome mediator interleukin-18 was associated with mortality in observational acute respiratory distress syndrome cohorts. Statin exposure increases both inflammasome activation and lung injury in mouse models. We tested whether randomization to statin therapy correlated with increased interleukin-18 in the ARDS Network Statins for Acutely Injured Lungs from Sepsis trial. DESIGN Retrospective analysis of randomized controlled clinical trial. SETTING Multicenter North American clinical trial, the ARDS Network Statins for Acutely Injured Lungs from Sepsis. PATIENTS Six hundred eighty-three subjects with infection-related acute respiratory distress syndrome, representing 92% of the original trial population. INTERVENTIONS Random assignment of rosuvastatin or placebo for up to 28 days or 3 days after ICU discharge. MEASUREMENTS AND MAIN RESULTS We measured plasma interleukin-18 levels in all Statins for Acutely Injured Lungs from Sepsis patients with sample available at day 0 (baseline, n = 683) and day 3 (after randomization, n = 588). We tested the association among interleukin-18 level at baseline, rising interleukin-18, and the impact of statin therapy on 60-day mortality, adjusting for severity of illness. Baseline plasma interleukin-18 level greater than or equal to 800 pg/mL was highly associated with 60-day mortality, with a hazard of death of 2.3 (95% CI, 1.7-3.1). Rising plasma interleukin-18 was also associated with increased mortality. For each unit increase in log2 (interleukin-18) at day 3 compared with baseline, the hazard of death increased by 2.3 (95% CI, 1.5-3.5). Subjects randomized to statin were significantly more likely to experience a rise in plasma interleukin-18 levels. Subjects with acute kidney injury, shock, low baseline interleukin-18, and those not receiving systemic corticosteroids were more likely to experience rising interleukin-18. Randomization to statin therapy was associated with rising in interleukin-18 in all of those subsets, however. CONCLUSIONS Elevated baseline plasma interleukin-18 was associated with higher mortality in sepsis-induced acute respiratory distress syndrome. A rise in plasma interleukin-18 was also associated with increased mortality and was more common in subjects randomized to statin therapy in this clinical trial.",2019,A rise in plasma interleukin-18 was also associated with increased mortality and was more common in subjects randomized to statin therapy in this clinical trial.,"['Acute Respiratory Distress Syndrome', 'Acutely Injured Lungs from Sepsis trial', 'Subjects with acute kidney injury', 'Multicenter North American clinical trial, the ARDS Network Statins for Acutely Injured Lungs from Sepsis', 'Six hundred eighty-three subjects with infection-related acute respiratory distress syndrome, representing 92% of the original trial population']","['rosuvastatin or placebo', 'statin therapy']","['hazard of death', '60-day mortality', 'Baseline plasma interleukin-18 level', 'plasma interleukin-18 levels', 'mortality']","[{'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",683.0,0.63108,A rise in plasma interleukin-18 was also associated with increased mortality and was more common in subjects randomized to statin therapy in this clinical trial.,"[{'ForeName': 'Angela J', 'Initials': 'AJ', 'LastName': 'Rogers', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'Jiazhen', 'Initials': 'J', 'LastName': 'Guan', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Trtchounian', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Gary M', 'Initials': 'GM', 'LastName': 'Hunninghake', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Rajani', 'Initials': 'R', 'LastName': 'Kaimal', 'Affiliation': 'Quantitative Sciences Unit, Department of Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Desai', 'Affiliation': 'Quantitative Sciences Unit, Department of Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'Lori-Ann', 'Initials': 'LA', 'LastName': 'Kozikowski', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of Massachusetts Medical School-Baystate, Springfield, MA.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'DeSouza', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of Massachusetts Medical School-Baystate, Springfield, MA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Mogan', 'Affiliation': 'Division of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine, Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Kathleen D', 'Initials': 'KD', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, Cardiovascular Research Institute, University of California, San Francisco, CA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Matthay', 'Affiliation': 'Department of Medicine, Cardiovascular Research Institute, University of California, San Francisco, CA.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Steingrub', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of Massachusetts Medical School-Baystate, Springfield, MA.'}, {'ForeName': 'Art', 'Initials': 'A', 'LastName': 'Wheeler', 'Affiliation': 'Division of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine, Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Joo Heon', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'Department of Otorhinolaryngology, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kiichi', 'Initials': 'K', 'LastName': 'Nakahira', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, New York, NY.'}, {'ForeName': 'Augustine M', 'Initials': 'AM', 'LastName': 'Choi', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, New York, NY.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Baron', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Boston, MA.""}]",Critical care medicine,['10.1097/CCM.0000000000003816'] 119,32240909,Compliance and tolerability of short-course radiotherapy followed by preoperative chemotherapy and surgery for high-risk rectal cancer - Results of the international randomized RAPIDO-trial.,"BACKGROUND Preoperative chemoradiotherapy (CRT) followed by total mesorectal excision is widely accepted as the standard of care for high-risk rectal cancer. Adjuvant chemotherapy is advised in several international guidelines, although the survival benefit remains unclear and compliance is poor. The current multidisciplinary approach has led to major improvements in local control, yet the occurrence of distant metastases has not decreased accordingly. The combination of short-course radiotherapy (SCRT) and chemotherapy in the waiting period before surgery might have several benefits, including higher compliance, downstaging and better effect of systemic therapy. METHODS This is an investigator-initiated, international multicentre randomized phase III trial. High-risk rectal cancer patients were randomized to SCRT followed by chemotherapy (6 cycles CAPOX or alternatively 9 cycles FOLFOX4) and subsequent surgery, or long-course radiotherapy (25-28 × 2-1.8 Gy) with concomitant capecitabine followed by surgery and optional postoperative chemotherapy (8 cycles CAPOX or 12 cycles FOLFOX4) according to local institutions' policy. The primary endpoint is time to disease-related treatment failure. Here, we report the compliance, toxicity and postoperative complications in both study groups. FINDINGS Between June 2011 and June 2016, 920 patients were enrolled. Of these, 901 were evaluable (460 in the experimental arm and 441 in the standard arm). All patients in the experimental arm received 5 × 5 Gy radiotherapy, and 84% of all patients received at least 75% of the prescribed chemotherapy. In the standard arm, the compliance for CRT was 93% and 58% for postoperative chemotherapy. Toxicity ≥grade 3 occurred in 48% of patients in the experimental arm, compared to 25% of patients in the standard arm during preoperative treatment and 35% of patients during postoperative chemotherapy. No statistically significant differences in surgical procedures or postoperative complications were observed. INTERPRETATION High compliance (84%) of preoperative systemic treatment could be achieved with the experimental approach. Although considerable toxicity was observed during preoperative therapy, this did not lead to differences in surgical procedures or postoperative complications. Longer follow-up time is needed to assess the primary endpoint and related outcomes.",2020,"Toxicity ≥grade 3 occurred in 48% of patients in the experimental arm, compared to 25% of patients in the standard arm during preoperative treatment and 35% of patients during postoperative chemotherapy.","['High-risk rectal cancer patients', 'high-risk rectal cancer ', 'Between June 2011 and June 2016, 920 patients were enrolled', '901 were evaluable (460 in the experimental arm and 441 in the standard arm']","['short-course radiotherapy', '5\xa0×\xa05 Gy radiotherapy', 'preoperative chemotherapy and surgery', 'short-course radiotherapy (SCRT) and chemotherapy', 'Adjuvant chemotherapy', 'Preoperative chemoradiotherapy (CRT', 'SCRT followed by chemotherapy (6 cycles CAPOX or alternatively 9 cycles FOLFOX4) and subsequent surgery, or long-course radiotherapy', 'concomitant capecitabine followed by surgery and optional postoperative chemotherapy']","['Toxicity ≥grade 3', 'time to disease-related treatment failure', 'Compliance and tolerability', 'compliance, toxicity and postoperative complications', 'toxicity', 'surgical procedures or postoperative complications']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C1273551', 'cui_str': 'Postoperative chemotherapy'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]",920.0,0.114836,"Toxicity ≥grade 3 occurred in 48% of patients in the experimental arm, compared to 25% of patients in the standard arm during preoperative treatment and 35% of patients during postoperative chemotherapy.","[{'ForeName': 'Maxime J M', 'Initials': 'MJM', 'LastName': 'van der Valk', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, The Netherlands. Electronic address: mvandervalk@lumc.nl.'}, {'ForeName': 'Corrie A M', 'Initials': 'CAM', 'LastName': 'Marijnen', 'Affiliation': 'Department of Radiotherapy, Leiden University Medical Center, The Netherlands; Department of Radiotherapy, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Boudewijn', 'Initials': 'B', 'LastName': 'van Etten', 'Affiliation': 'Department of Surgery, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Esmée A', 'Initials': 'EA', 'LastName': 'Dijkstra', 'Affiliation': 'Department of Medical Oncology, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Denise E', 'Initials': 'DE', 'LastName': 'Hilling', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Elma Meershoek-Klein', 'Initials': 'EM', 'LastName': 'Kranenbarg', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Department of Medical Statistics, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Annet G H', 'Initials': 'AGH', 'LastName': 'Roodvoets', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Renu R', 'Initials': 'RR', 'LastName': 'Bahadoer', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Tone', 'Initials': 'T', 'LastName': 'Fokstuen', 'Affiliation': 'Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Albert Jan', 'Initials': 'AJ', 'LastName': 'Ten Tije', 'Affiliation': 'Department of Medical Oncology, Amphia Hospital, Breda, The Netherlands.'}, {'ForeName': 'Jaume', 'Initials': 'J', 'LastName': 'Capdevila', 'Affiliation': 'Department of Medical Oncology, Vall Hebron University Hospital, Vall Hebron Institute of Oncology (VHIO). Barcelona, Spain.'}, {'ForeName': 'Mathijs P', 'Initials': 'MP', 'LastName': 'Hendriks', 'Affiliation': 'Department of Medical Oncology, Northwest Clinics, Alkmaar, The Netherlands.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Edhemovic', 'Affiliation': 'Department of Surgical Oncology, Institute of Oncology Ljubljana, Slovenia.'}, {'ForeName': 'Andrès M R', 'Initials': 'AMR', 'LastName': 'Cervantes', 'Affiliation': 'Department of Medical Oncology, Hospital Clínico Universitario de Valencia, Spain.'}, {'ForeName': 'Derk Jan A', 'Initials': 'DJA', 'LastName': 'de Groot', 'Affiliation': 'Department of Medical Oncology, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Per J', 'Initials': 'PJ', 'LastName': 'Nilsson', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Glimelius', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Uppsala University, Sweden.'}, {'ForeName': 'Cornelis J H', 'Initials': 'CJH', 'LastName': 'van de Velde', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Geke A P', 'Initials': 'GAP', 'LastName': 'Hospers', 'Affiliation': 'Department of Medical Oncology, University of Groningen, University Medical Center Groningen, The Netherlands. Electronic address: g.a.p.hospers@umcg.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.03.011'] 120,31997084,Effects of Green Tea Extract on Atorvastatin Pharmacokinetics in Healthy Volunteers.,"BACKGROUND AND OBJECTIVES Green tea catechins were recently reported to inhibit drug transporters such as organic anion-transporting polypeptides (OATPs) and metabolic enzymes, affecting the bioavailability of many drugs. This study aimed to evaluate the clinical significance of the effects of different doses of green tea extract on the pharmacokinetic parameters of atorvastatin and to rationalize the associated interaction mechanism. METHODS A randomized, double-blind, three-phase crossover study involving 12 healthy volunteers was performed. Participants received a single dose of atorvastatin 40 mg alone (control group), atorvastatin 40 mg plus a capsule containing 300 mg of dry green tea extract, or atorvastatin 40 mg plus a capsule containing 600 mg of dry green tea extract. Plasma samples taken from the volunteers were analyzed for atorvastatin using liquid chromatography-tandom mass spectrometry (LC/MS/MS). RESULTS Compared to atorvastatin alone, the administration of 300 mg or 600 mg of the green tea extract along with atorvastatin decreased the peak plasma concentration (C max ) of atorvastatin by 25% and 24%, respectively (P < 0.05), and the area under the plasma concentration-time curve (AUC 0-∞ ) of atorvastatin by 24% and 22%, respectively (P < 0.05). Additionally, administration of 300 mg or 600 mg of the green tea extract increased the apparent oral clearance (CL/F) of atorvastatin by 31% and 29%, respectively. The time to C max (T max ) and the elimination half-life (t 1/2 ) of atorvastatin did not differ among the three phases. The effects of 600 mg of the green tea extract on the pharmacokinetic parameters of atorvastatin were not significantly different from the effects of 300 mg of the green tea extract. CONCLUSION Green tea extract decreases the absorption but not the elimination of atorvastatin, possibly by inhibiting OATP, albeit not in a dose-dependent manner. Coadministration of green tea extract with atorvastatin may necessitate the monitoring of the plasma concentration of atorvastatin in clinical practice.",2020,"The effects of 600 mg of the green tea extract on the pharmacokinetic parameters of atorvastatin were not significantly different from the effects of 300 mg of the green tea extract. ","['12 healthy volunteers', 'Healthy Volunteers']","['Green Tea Extract', 'green tea extract with atorvastatin', 'atorvastatin', 'green tea extract', 'atorvastatin 40\xa0mg alone (control group), atorvastatin 40\xa0mg plus a capsule containing 300\xa0mg of dry green tea extract, or atorvastatin 40\xa0mg plus a capsule containing 600\xa0mg of dry green tea extract', 'Green tea extract']","['Atorvastatin Pharmacokinetics', 'peak plasma concentration (C max ) of atorvastatin', 'time to C max (T max ) and the elimination half-life', 'area under the plasma concentration-time curve (AUC 0-∞ ) of atorvastatin', 'apparent oral clearance (CL/F) of atorvastatin', 'pharmacokinetic parameters of atorvastatin']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1704263', 'cui_str': 'Green Tea Extract'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C1616508', 'cui_str': 'atorvastatin 40 MG [Lipitor]'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C3816748', 'cui_str': '600'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",12.0,0.0478265,"The effects of 600 mg of the green tea extract on the pharmacokinetic parameters of atorvastatin were not significantly different from the effects of 300 mg of the green tea extract. ","[{'ForeName': 'Khaled S', 'Initials': 'KS', 'LastName': 'Abdelkawy', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Kafrelsheikh University, Kafrelsheikh City, Egypt.'}, {'ForeName': 'Reham M', 'Initials': 'RM', 'LastName': 'Abdelaziz', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Kafrelsheikh University, Kafrelsheikh City, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Abdelmageed', 'Affiliation': 'Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Kafrelsheikh University, Kafrelsheikh City, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Donia', 'Affiliation': 'Pharmaceutical Technology Department, Faculty of Pharmacy, Menofia University, Menofia City, Egypt.'}, {'ForeName': 'Noha M', 'Initials': 'NM', 'LastName': 'El-Khodary', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Damanhour University, Damanhour, Egypt. nohamahmoud_55@hotmail.com.'}]",European journal of drug metabolism and pharmacokinetics,['10.1007/s13318-020-00608-6'] 121,31981043,Endoscopic Argon Plasma Coagulation vs. Multidisciplinary Evaluation in the Management of Weight Regain After Gastric Bypass Surgery: a Randomized Controlled Trial with SHAM Group.,"BACKGROUND Roux-en-Y gastric bypass is one of the most widely performed bariatric surgeries. However, the relapse of obesity occurs in approximately 20% of patients and enlargement of the anastomosis is one of the factors associated with this relapse. Endoscopic treatment of the anastomosis has been proposed to assist in renewed weight loss. One endoscopic technique is the narrowing of the anastomosis argon plasma coagulation (APC). OBJECTIVE Evaluate the effectiveness and safety of the endoscopic treatment of an enlarged anastomosis with APC. METHODS A randomized controlled study was conducted comparing APC to exclusive multidisciplinary management after weight regain. RESULTS Forty-two patients were divided into two groups: APC (n = 22) and control (n = 20). After 14 months of follow-up with a crossover at 6 months, significant improvement in satiety and greater weight loss were found in the APC group and after crossover. APC was associated with significant weight loss [9.73 (7.46, 12) vs. + 1.38 (- 1.39, 2.15)], a reduction in the anastomosis diameter [p < 0.001], early satiation [0.77 (0.44, 1.11) vs. - 0.59 (- 0.95, - 0.23), p < 0.001], and increased quality of life measured using the EQ5D index [p = 0.04] and EQ5D VAS scale [p = 0.04]. Considering total mean weight loss throughout the entire follow-up, weight loss was similar in both groups (13.02 kg in the APC and 11.52 kg in the control). CONCLUSION Treatment of the gastrojejunal anastomosis with APC was effective and safe, with significant weight loss, the return of early satiation, and an improvement in quality of life.",2020,"Considering total mean weight loss throughout the entire follow-up, weight loss was similar in both groups (13.02 kg in the APC and 11.52 kg in the control). ","['After Gastric Bypass Surgery', 'Forty-two patients']","['Endoscopic Argon Plasma Coagulation vs. Multidisciplinary Evaluation', 'APC', 'SHAM']","['quality of life', 'satiety and greater weight loss', 'weight loss', 'EQ5D VAS scale', 'effectiveness and safety', 'total mean weight loss', 'weight loss, the return of early satiation', 'relapse of obesity occurs', 'Weight Regain']","[{'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1879736', 'cui_str': 'Argon Beam Coagulation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0034380'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0222045'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",42.0,0.0503247,"Considering total mean weight loss throughout the entire follow-up, weight loss was similar in both groups (13.02 kg in the APC and 11.52 kg in the control). ","[{'ForeName': 'Luiz Gustavo', 'Initials': 'LG', 'LastName': 'de Quadros', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil. Gustavo_quadros@hotmail.com.'}, {'ForeName': 'Manoel Galvão', 'Initials': 'MG', 'LastName': 'Neto', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'João Caetano', 'Initials': 'JC', 'LastName': 'Marchesini', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Teixeira', 'Affiliation': 'Orlando Health Hospital, Orlando, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Grecco', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'Roberto Luiz Kaiser', 'Initials': 'RLK', 'LastName': 'Junior', 'Affiliation': 'Beneficência Portuguesa Hospital, Sao Jose do Rio Preto, São Paulo, Brazil.'}, {'ForeName': 'Natan', 'Initials': 'N', 'LastName': 'Zundel', 'Affiliation': 'Jackson North Medical Center, University at Buffalo, Miami, USA.'}, {'ForeName': 'Idiberto José Zotarelli', 'Initials': 'IJZ', 'LastName': 'Filho', 'Affiliation': 'Kaiser Day Hospital, Sao Jose do Rio Preto, São Paulo, Brazil.'}, {'ForeName': 'Thiago Ferreira', 'Initials': 'TF', 'LastName': 'de Souza', 'Affiliation': 'Hospital das Clínicas da Faculdade de Medicina, Universidade de São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Admar Concon', 'Initials': 'AC', 'LastName': 'Filho', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'Lyz Bezerra', 'Initials': 'LB', 'LastName': 'da Silva', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Almino Cardoso', 'Initials': 'AC', 'LastName': 'Ramos', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'Álvaro Antônio Bandeira', 'Initials': 'ÁAB', 'LastName': 'Ferraz', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Josemberg Marins', 'Initials': 'JM', 'LastName': 'Campos', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}]",Obesity surgery,['10.1007/s11695-020-04414-6'] 122,31942688,Weight Loss and Vomiting 1 Year After Banded Versus Non-banded One Anastomosis Gastric Bypass: a Prospective Randomized Trial.,"BACKGROUND The weight loss outcomes after banded one-anastomosis gastric bypass (OAGB) remain to be determined. OBJECTIVE To compare weight loss and vomiting 1 year after banded versus non-banded OAGB. METHODS This is a prospective, open-label, randomized study, which evaluated 33 individuals with morbid obesity, which underwent banded (16 individuals) and non-banded OAGB (17 individuals) and were followed up for 12 months. Weight loss (percentages of total weight loss-%TWL-and excess weight loss-%EWL) and occurrence of vomiting were assessed and compared before surgery and after 6 and 12 months. RESULTS At baseline, there were no differences between groups in regard to age, gender, and body mass index (BMI). At 6 and 12 months post-op, and the overall mean %TWL regardless of band use was 22.4 ± 7% and 29 ± 6.9%, respectively, and the overall average %EWL regardless of band use was 66.8 ± 22.9% and 86.3 ± 24%, respectively. %TWL did not differ between the banded and non-banded groups at 6 (21.8 ± 6.8% vs. 23.1 ± 7.4%; p = 0.7) and 12 months post-op (27.5 ± 6.6% vs. 30.4 ± 7.1%; p = 0.3), as well as %EWL at 6 (67 ± 22.9% vs. 67.6 ± 23.6%; p = 0.6) and 12 months post-op (83.5 ± 24.4% vs. 89 ± 24.1%; p = 0.4). The occurrence of vomiting did not significantly differ between banded and non-banded OAGB at 6 (12.5% vs. 11.8%; p = 0.9) and 12 months post-op (12.5% vs. 5.9%; p = 0.5). CONCLUSION OAGB led to an overall satisfactory weight loss after 1 year, regardless of band use. Banded OAGB did not lead to neither significantly higher weight loss nor more vomiting than non-banded OAGB 1 year after surgery.",2020,Banded OAGB did not lead to neither significantly higher weight loss nor more vomiting than non-banded OAGB 1 year after surgery.,"['33 individuals with morbid obesity, which underwent banded (16 individuals) and non-banded OAGB (17 individuals) and were followed up for 12\xa0months']","['OAGB', 'Banded Versus Non-banded One Anastomosis Gastric Bypass']","['weight loss and vomiting 1\xa0year', 'overall satisfactory weight loss', 'weight loss nor more vomiting', 'Weight Loss and Vomiting 1 Year', 'occurrence of vomiting', 'Weight loss (percentages of total weight', 'loss-%TWL-and excess weight loss-%EWL) and occurrence of vomiting']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028756', 'cui_str': 'Obesity, Severe'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0042965', 'cui_str': 'Vomitus (substance)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",,0.0252491,Banded OAGB did not lead to neither significantly higher weight loss nor more vomiting than non-banded OAGB 1 year after surgery.,"[{'ForeName': 'Everton', 'Initials': 'E', 'LastName': 'Cazzo', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), São Paulo, Brazil. notrevezzo@yahoo.com.'}, {'ForeName': 'Laísa Simakawa', 'Initials': 'LS', 'LastName': 'Jimenez', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), São Paulo, Brazil.'}, {'ForeName': 'Felipe Gilberto', 'Initials': 'FG', 'LastName': 'Valerini', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), São Paulo, Brazil.'}, {'ForeName': 'Tiago Bezerra', 'Initials': 'TB', 'LastName': 'de Freitas Diniz', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), São Paulo, Brazil.'}, {'ForeName': 'Almino Cardoso', 'Initials': 'AC', 'LastName': 'Ramos', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), São Paulo, Brazil.'}, {'ForeName': 'Elinton Adami', 'Initials': 'EA', 'LastName': 'Chaim', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), São Paulo, Brazil.'}]",Obesity surgery,['10.1007/s11695-020-04393-8'] 123,32053137,Effect of Pembrolizumab Plus Neoadjuvant Chemotherapy on Pathologic Complete Response in Women With Early-Stage Breast Cancer: An Analysis of the Ongoing Phase 2 Adaptively Randomized I-SPY2 Trial.,"Importance Approximately 25% of patients with early-stage breast cancer who receive (neo)adjuvant chemotherapy experience a recurrence within 5 years. Improvements in therapy are greatly needed. Objective To determine if pembrolizumab plus neoadjuvant chemotherapy (NACT) in early-stage breast cancer is likely to be successful in a 300-patient, confirmatory randomized phase 3 neoadjuvant clinical trial. Design, Setting, and Participants The I-SPY2 study is an ongoing open-label, multicenter, adaptively randomized phase 2 platform trial for high-risk, stage II/III breast cancer, evaluating multiple investigational arms in parallel. Standard NACT serves as the common control arm; investigational agent(s) are added to this backbone. Patients with ERBB2 (formerly HER2)-negative breast cancer were eligible for randomization to pembrolizumab between November 2015 and November 2016. Interventions Participants were randomized to receive taxane- and anthracycline-based NACT with or without pembrolizumab, followed by definitive surgery. Main Outcomes and Measures The primary end point was pathologic complete response (pCR). Secondary end points were residual cancer burden (RCB) and 3-year event-free and distant recurrence-free survival. Investigational arms graduated when demonstrating an 85% predictive probability of success in a hypothetical confirmatory phase 3 trial. Results Of the 250 women included in the final analysis, 181 were randomized to the standard NACT control group (median [range] age, 47 [24.77] years). Sixty-nine women (median [range] age, 50 [27-71] years) were randomized to 4 cycles of pembrolizumab in combination with weekly paclitaxel followed by AC; 40 hormone receptor (HR)-positive and 29 triple-negative. Pembrolizumab graduated in all 3 biomarker signatures studied. Final estimated pCR rates, evaluated in March 2017, were 44% vs 17%, 30% vs 13%, and 60% vs 22% for pembrolizumab vs control in the ERBB2-negative, HR-positive/ERBB2-negative, and triple-negative cohorts, respectively. Pembrolizumab shifted the RCB distribution to a lower disease burden for each cohort evaluated. Adverse events included immune-related endocrinopathies, notably thyroid abnormalities (13.0%) and adrenal insufficiency (8.7%). Achieving a pCR appeared predictive of long-term outcome, where patients with pCR following pembrolizumab plus chemotherapy had high event-free survival rates (93% at 3 years with 2.8 years' median follow-up). Conclusions and Relevance When added to standard neoadjuvant chemotherapy, pembrolizumab more than doubled the estimated pCR rates for both HR-positive/ERBB2-negative and triple-negative breast cancer, indicating that checkpoint blockade in women with early-stage, high-risk, ERBB2-negative breast cancer is highly likely to succeed in a phase 3 trial. Pembrolizumab was the first of 10 agents to graduate in the HR-positive/ERBB2-negative signature. Trial Registration ClinicalTrials.gov Identifier: NCT01042379.",2020,"Adverse events included immune-related endocrinopathies, notably thyroid abnormalities (13.0%) and adrenal insufficiency (8.7%).","['250 women included in the final analysis', 'patients with early-stage breast cancer who receive', 'Women With Early-Stage Breast Cancer', 'early-stage breast cancer', 'median [range] age, 50 [27-71] years', 'Patients with ERBB2 (formerly HER2)-negative breast cancer were eligible for randomization to pembrolizumab between November 2015 and November 2016', 'Sixty-nine women']","['standard NACT control', 'pembrolizumab in combination with weekly paclitaxel followed by AC; 40 hormone receptor (HR)-positive and 29 triple-negative', 'pembrolizumab plus neoadjuvant chemotherapy (NACT', 'Pembrolizumab', 'taxane- and anthracycline-based NACT with or without pembrolizumab, followed by definitive surgery', 'pembrolizumab plus chemotherapy', 'pembrolizumab', 'Pembrolizumab Plus Neoadjuvant Chemotherapy']","['Pathologic Complete Response', 'adrenal insufficiency', 'pCR rates', 'high event-free survival rates', 'residual cancer burden (RCB) and 3-year event-free and distant recurrence-free survival', 'pathologic complete response (pCR', 'immune-related endocrinopathies, notably thyroid abnormalities']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0001623', 'cui_str': 'Adrenal Insufficiency'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0242594', 'cui_str': 'Residual Cancer'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}]",69.0,0.270206,"Adverse events included immune-related endocrinopathies, notably thyroid abnormalities (13.0%) and adrenal insufficiency (8.7%).","[{'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Nanda', 'Affiliation': 'The University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Minetta C', 'Initials': 'MC', 'LastName': 'Liu', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Yau', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Shatsky', 'Affiliation': 'University of California, San Diego.'}, {'ForeName': 'Lajos', 'Initials': 'L', 'LastName': 'Pusztai', 'Affiliation': 'Yale University, New Haven, Connecticut.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Wallace', 'Affiliation': 'University of California, San Diego.'}, {'ForeName': 'A Jo', 'Initials': 'AJ', 'LastName': 'Chien', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Forero-Torres', 'Affiliation': 'University of Alabama, Birmingham.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Ellis', 'Affiliation': 'Swedish Cancer Center.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Han', 'Affiliation': 'Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Clark', 'Affiliation': 'University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Albain', 'Affiliation': 'Loyola University Chicago Stritch School of Medicine, Maywood, Illinois.'}, {'ForeName': 'Judy C', 'Initials': 'JC', 'LastName': 'Boughey', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Nora T', 'Initials': 'NT', 'LastName': 'Jaskowiak', 'Affiliation': 'The University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Elias', 'Affiliation': 'University of Colorado, Aurora.'}, {'ForeName': 'Claudine', 'Initials': 'C', 'LastName': 'Isaacs', 'Affiliation': 'Georgetown University, Washington, DC.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Kemmer', 'Affiliation': 'Oregon Health & Science University, Portland.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Helsten', 'Affiliation': 'University of California, San Diego.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Majure', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Stringer-Reasor', 'Affiliation': 'University of Alabama, Birmingham.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Parker', 'Affiliation': 'The University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Marie C', 'Initials': 'MC', 'LastName': 'Lee', 'Affiliation': 'Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Tufia', 'Initials': 'T', 'LastName': 'Haddad', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Ronald N', 'Initials': 'RN', 'LastName': 'Cohen', 'Affiliation': 'The University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Asare', 'Affiliation': 'Quantum Leap Healthcare Collaborative, San Francisco, California.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'Quantum Leap Healthcare Collaborative, San Francisco, California.'}, {'ForeName': 'Gillian L', 'Initials': 'GL', 'LastName': 'Hirst', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Ruby', 'Initials': 'R', 'LastName': 'Singhrao', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Steeg', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Asare', 'Affiliation': 'Quantum Leap Healthcare Collaborative, San Francisco, California.'}, {'ForeName': 'Jeffrey B', 'Initials': 'JB', 'LastName': 'Matthews', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Berry', 'Affiliation': 'Berry Consultants, LLC.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Sanil', 'Affiliation': 'Berry Consultants, LLC.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Schwab', 'Affiliation': 'University of California, San Diego.'}, {'ForeName': 'W Fraser', 'Initials': 'WF', 'LastName': 'Symmans', 'Affiliation': 'MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': ""van 't Veer"", 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Yee', 'Affiliation': 'University of Minnesota, Minneapolis.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'DeMichele', 'Affiliation': 'University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Nola M', 'Initials': 'NM', 'LastName': 'Hylton', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Melisko', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Perlmutter', 'Affiliation': 'Gemini Group, Ann Arbor, Michigan.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Berry', 'Affiliation': 'Berry Consultants, LLC.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Esserman', 'Affiliation': 'University of California, San Francisco.'}]",JAMA oncology,['10.1001/jamaoncol.2019.6650'] 124,32291620,Efficacy of furosemide-albumin compared with furosemide in critically ill hypoalbuminemia patients admitted to intensive care unit: a prospective randomized clinical trial.,"BACKGROUND Some physicians co-administer albumin with loop diuretics to overcome diuretic resistance in critically ill hypoalbuminemia patients, though previous studies have reported conflicting results on this matter. OBJECTIVE The effects of adding albumin to furosemide to enhance its efficacy in critically ill hypoalbuminemia patients are evaluated. METHODS This was a non-blinded randomized trial. 49 adult critically ill patients with hypoalbuminemia and generalized edema who received randomly furosemide and furosemide/albumin complex were enrolled. The patients' urine was collected at intervals of 2, 4, 6 and 8 h after initiation of the furosemide treatment, and the urine output and urinary excretion of furosemide and sodium were measured. The urinary excretion of furosemide was considered an indicator of drug efficacy. RESULTS The amount of sodium and furosemide excreted in urine showed no significant differences between the two groups; however, the mean of the urinary excretion of furosemide in the first 2 h after drug infusion was significantly higher (p = 0.03) in the furosemide/albumin group. No significant correlation between APACHE II scores and serum albumin levels and the urinary excretion of furosemide was seen. CONCLUSION The results indicated that there is not statistically significant differences between groups with furosemide alone and combined with albumin in urinary furosemide excretion. It seems that adding albumin for furosemide pharmacotherapy regime is not recommended as an intervention to increase furosemide efficacy in critically ill hypoalbuminemia patients. TRIAL REGISTRATION IRCT with the registration number IRCT201412132582N12 in 23 February 2015; https://en.irct.ir/trial/2356 Graphical abstract.",2020,"The amount of sodium and furosemide excreted in urine showed no significant differences between the two groups; however, the mean of the urinary excretion of furosemide in the first 2 h after drug infusion was significantly higher (p = 0.03) in the furosemide/albumin group.","['49 adult critically ill patients with hypoalbuminemia and generalized edema who received', 'critically ill hypoalbuminemia patients', 'critically ill hypoalbuminemia patients admitted to intensive care unit', '23 February 2015; https://en.irct.ir/trial/2356 Graphical abstract']","['furosemide-albumin', 'albumin to furosemide', 'furosemide', 'randomly furosemide and furosemide/albumin complex']","['APACHE II scores and serum albumin levels', 'urinary excretion of furosemide', 'furosemide efficacy', 'urine output and urinary excretion of furosemide and sodium', 'urinary furosemide excretion']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0239981', 'cui_str': 'Hypoalbuminemia'}, {'cui': 'C0151603', 'cui_str': 'Anasarca'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit'}, {'cui': 'C0000857', 'cui_str': 'Abstracting as Topic'}]","[{'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}]","[{'cui': 'C0489438', 'cui_str': 'APACHE II score'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}]",49.0,0.10447,"The amount of sodium and furosemide excreted in urine showed no significant differences between the two groups; however, the mean of the urinary excretion of furosemide in the first 2 h after drug infusion was significantly higher (p = 0.03) in the furosemide/albumin group.","[{'ForeName': 'Ata', 'Initials': 'A', 'LastName': 'Mahmoodpoor', 'Affiliation': 'Department of Anesthesiology, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Sahra', 'Initials': 'S', 'LastName': 'Zahedi', 'Affiliation': 'Iranian Evidence Based Medicine Center of Excellence, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Arezou', 'Initials': 'A', 'LastName': 'Pourakbar', 'Affiliation': 'Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Hamishehkar', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Shadvar', 'Affiliation': 'Department of Anesthesiology, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Parina', 'Initials': 'P', 'LastName': 'Asgharian', 'Affiliation': 'Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Farnaz', 'Initials': 'F', 'LastName': 'Shahabi', 'Affiliation': 'Department of Anesthesiology, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Hamishehkar', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. hamishehkar@gmail.com.'}]","Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences",['10.1007/s40199-020-00339-8'] 125,32289829,Effects of Bupivacaine on Opioid Patient-Controlled Intrathecal Analgesia in Chronic Pain Patients Implanted with Drug Delivery Systems.,"BACKGROUND Combining neuraxial opioids and local anesthetics in acute pain results in improved duration of analgesia and reduced dosages and adverse effects. Although commonly used in intrathecal drug delivery systems (IDDS) for chronic pain, the effectiveness of this admixture has not been examined specifically in relation to patient-controlled intrathecal analgesia (PCIA). METHODS IDDS-implanted chronic noncancer pain patients receiving opioids with bupivacaine (O + B) were randomized to receive either opioids without bupivacaine (O) or O + B in a double-blind manner, at IDDS refills, for one week and then crossed over to the other solution for another week. Primary outcome measures included numeric rating scale (NRS) pain scores before and within 30 minutes after PCIA boluses. Secondary outcome measures included average NRS scores and functional outcome measures. RESULTS Seventeen patients were enrolled, and 16 patients completed the study. There were no differences in NRS scores before and after PCIA boluses between the O and O + B conditions, though pain scores improved significantly (average decrease in NRS scores: O 1.81 ± 1.47 vs O + B 1.87 ± 1.40, P = 0.688). No differences were noted in speed of onset or duration of analgesia. Although more patients subjectively preferred the O + B treatment, the difference was not statistically significant. No differences were noted in secondary outcome measures, with the exception of global impression of change having higher scores in O compared with O + B. CONCLUSIONS Acutely removing bupivacaine from a chronic intrathecal infusion of opioids and bupivacaine in patients with chronic noncancer pain did not adversely affect PCIA effectiveness, nor did it affect speed of onset or duration of effect. These findings are divergent from those in acute pain and may have to do with study conditions and pain phenotypes.",2021,"There were no differences in NRS scores before and after PCIA boluses between the O and O + B conditions, though pain scores improved significantly (average decrease in NRS scores: O 1.81 ± 1.47 vs O + B 1.87 ± 1.40, P = 0.688).","['patients with chronic noncancer pain', 'Chronic Pain Patients Implanted with Drug Delivery Systems', 'Seventeen patients were enrolled, and 16 patients completed the study', 'IDDS-implanted chronic noncancer pain patients receiving opioids with bupivacaine (O\u2009+\u2009B']","['Bupivacaine', 'opioids without bupivacaine (O) or O\u2009+\u2009B', 'bupivacaine']","['NRS scores', 'speed of onset or duration of analgesia', 'pain scores', 'numeric rating scale (NRS) pain scores', 'average NRS scores and functional outcome measures', 'PCIA effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",17.0,0.124256,"There were no differences in NRS scores before and after PCIA boluses between the O and O + B conditions, though pain scores improved significantly (average decrease in NRS scores: O 1.81 ± 1.47 vs O + B 1.87 ± 1.40, P = 0.688).","[{'ForeName': 'Salim M', 'Initials': 'SM', 'LastName': 'Hayek', 'Affiliation': 'Division of Pain Medicine, Case Western Reserve University, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'McEwan', 'Affiliation': 'Division of Pain Medicine, Case Western Reserve University, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Veizi', 'Affiliation': 'Department of Anesthesiology, Case Western Reserve University, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'DeLozier', 'Affiliation': 'Clinical Research Center, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Mariya', 'Initials': 'M', 'LastName': 'Pogrebetskaya', 'Affiliation': 'Department of Anesthesiology, Case Western Reserve University, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa076'] 126,32293670,Application of social marketing to recruitment for a digital weight management intervention for young adults.,"Recruiting young adults into weight loss interventions poses challenges that may be mitigated by the use of novel social marketing strategies. The purpose of this study is to describe how social marketing principles were applied to recruitment for a digitally delivered randomized controlled trial for weight management among young adults and report recruitment data and demographics on those who enrolled and did not enroll in the study. The marketing mix of the 7Ps (i.e., product, price, place, promotion, packaging, positioning, and people) was applied to intervention recruitment. Prior to enrollment, respondents completed a screening survey, which was examined to determine optimal strategies for study awareness and enrollment. Of the initial 5,731 who initiated a screener, 3,059 provided data on the source of where they heard about the study. Subsequently, 460 (12.5%) were enrolled in the study, 409 (51.3% non-White; 78.7% female; body mass index: 30.6 ± 4.3) provided data on recruitment source, with emails (72.5%), cited most often followed by flyers/posters (8.8%), ""other"" (6.7%), and multiple sources (6.6%). Although email remained the most frequently cited promotion source, Pearson's chi-squared tests revealed that, compared to those not enrolled in the study, those who enrolled were more likely to hear about the study via flyers/posters (enrolled = 14.4%; not enrolled = 7.9%; p < .001) and multiple sources (enrolled = 11.7%; not enrolled 5.85%; p < .01) and less likely to hear via email (enrolled = 62.1%; not enrolled = 74.2%; p < .01). This study applied social marketing principles to successfully recruit a large and diverse group of young adults. While email emerged as the most effective source of study awareness, multiple channels and a mix of marketing principles are recommended for recruiting in university settings.",2021,"Although email remained the most frequently cited promotion source, Pearson's chi-squared tests revealed that, compared to those not enrolled in the study, those who enrolled were more likely to hear about the study via flyers/posters (enrolled = 14.4%; not enrolled = 7.9%; p < .001) and multiple sources (enrolled = 11.7%; not enrolled 5.85%; p < .01) and less likely to hear via email (enrolled = 62.1%; not enrolled = 74.2%; p < .01).","['young adults and report recruitment data and demographics on those who enrolled and did not enroll in the study', 'Subsequently, 460 (12.5%) were enrolled in the study, 409 (51.3% non-White; 78.7% female; body mass index: 30.6 ± 4.3) provided data on recruitment source, with emails (72.5%), cited most often followed by flyers/posters (8.8%), ""other"" (6.7%), and multiple sources (6.6', 'young adults']",[],[],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517759', 'cui_str': '4.3'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0376675', 'cui_str': 'Posters'}, {'cui': 'C4517882', 'cui_str': '8.8'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C4517823', 'cui_str': '6.6'}]",[],[],,0.0169774,"Although email remained the most frequently cited promotion source, Pearson's chi-squared tests revealed that, compared to those not enrolled in the study, those who enrolled were more likely to hear about the study via flyers/posters (enrolled = 14.4%; not enrolled = 7.9%; p < .001) and multiple sources (enrolled = 11.7%; not enrolled 5.85%; p < .01) and less likely to hear via email (enrolled = 62.1%; not enrolled = 74.2%; p < .01).","[{'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Whiteley', 'Affiliation': 'Department of Exercise and Health Sciences, University of Massachusetts Boston, Boston, MA, USA.'}, {'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Faro', 'Affiliation': 'Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, USA.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Mavredes', 'Affiliation': 'Department of Prevention and Community Health, The George Washington University, Washington, DC, USA.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Hayman', 'Affiliation': 'Departments of Prevention and Community Health and Exercise and Nutrition Sciences, Boston, MA, USA.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Napolitano', 'Affiliation': 'Department of Prevention and Community Health, The George Washington University, Washington, DC, USA.'}]",Translational behavioral medicine,['10.1093/tbm/ibaa032'] 127,32289388,"A phase 2, multicenter, placebo-controlled study of single-dose squaric acid dibutyl ester to reduce frequency of outbreaks in patients with recurrent herpes labialis.",,2020,,[],[],[],[],[],[],,0.0560587,,"[{'ForeName': 'Anne Lynn S', 'Initials': 'ALS', 'LastName': 'Chang', 'Affiliation': 'Department of Dermatology, Stanford University School of Medicine, Redwood City, California.'}, {'ForeName': 'Golara', 'Initials': 'G', 'LastName': 'Honari', 'Affiliation': 'Department of Dermatology, Stanford University School of Medicine, Redwood City, California.'}, {'ForeName': 'Linna', 'Initials': 'L', 'LastName': 'Guan', 'Affiliation': 'Department of Dermatology, Stanford University School of Medicine, Redwood City, California.'}, {'ForeName': 'Ludan', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Department of Dermatology, Stanford University School of Medicine, Redwood City, California.'}, {'ForeName': 'Maria Alora', 'Initials': 'MA', 'LastName': 'Palli', 'Affiliation': 'Department of Dermatology, Massachusetts General Hospital, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Horn', 'Affiliation': 'Department of Dermatology, Massachusetts General Hospital, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts; Squarex, LLC, Pine Springs, Minnesota.'}, {'ForeName': 'Arkadiusz Z', 'Initials': 'AZ', 'LastName': 'Dudek', 'Affiliation': 'Squarex, LLC, Pine Springs, Minnesota.'}, {'ForeName': 'Hugh', 'Initials': 'H', 'LastName': 'McTavish', 'Affiliation': 'Squarex, LLC, Pine Springs, Minnesota. Electronic address: hmctavish@squarex-pharma.com.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.04.021'] 128,32268027,Physical Therapy versus Glucocorticoid Injection for Osteoarthritis of the Knee.,"BACKGROUND Both physical therapy and intraarticular injections of glucocorticoids have been shown to confer clinical benefit with respect to osteoarthritis of the knee. Whether the short-term and long-term effectiveness for relieving pain and improving physical function differ between these two therapies is uncertain. METHODS We conducted a randomized trial to compare physical therapy with glucocorticoid injection in the primary care setting in the U.S. Military Health System. Patients with osteoarthritis in one or both knees were randomly assigned in a 1:1 ratio to receive a glucocorticoid injection or to undergo physical therapy. The primary outcome was the total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 1 year (scores range from 0 to 240, with higher scores indicating worse pain, function, and stiffness). The secondary outcomes were the time needed to complete the Alternate Step Test, the time needed to complete the Timed Up and Go test, and the score on the Global Rating of Change scale, all assessed at 1 year. RESULTS We enrolled 156 patients with a mean age of 56 years; 78 patients were assigned to each group. Baseline characteristics, including severity of pain and level of disability, were similar in the two groups. The mean (±SD) baseline WOMAC scores were 108.8±47.1 in the glucocorticoid injection group and 107.1±42.4 in the physical therapy group. At 1 year, the mean scores were 55.8±53.8 and 37.0±30.7, respectively (mean between-group difference, 18.8 points; 95% confidence interval, 5.0 to 32.6), a finding favoring physical therapy. Changes in secondary outcomes were in the same direction as those of the primary outcome. One patient fainted while receiving a glucocorticoid injection. CONCLUSIONS Patients with osteoarthritis of the knee who underwent physical therapy had less pain and functional disability at 1 year than patients who received an intraarticular glucocorticoid injection. (ClinicalTrials.gov number, NCT01427153.).",2020,The mean (±SD) baseline WOMAC scores were 108.8±47.1 in the glucocorticoid injection group and 107.1±42.4 in the physical therapy group.,"['Patients with osteoarthritis of the knee who underwent', 'Patients with osteoarthritis in one or both knees', 'primary care setting in the U.S. Military Health System', '156 patients with a mean age of 56 years; 78 patients', 'Osteoarthritis of the Knee']","['Physical Therapy versus Glucocorticoid Injection', 'physical therapy with glucocorticoid injection', 'glucocorticoids', 'glucocorticoid injection', 'glucocorticoid injection or to undergo physical therapy', 'intraarticular glucocorticoid injection', 'physical therapy']","['severity of pain and level of disability', 'time needed to complete the Alternate Step Test, the time needed to complete the Timed Up and Go test, and the score on the Global Rating of Change scale', 'mean (±SD) baseline WOMAC scores', 'mean scores', 'total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC', 'pain and functional disability', 'pain, function, and stiffness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0230434', 'cui_str': 'Both knees'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C5197818', 'cui_str': 'Military Health System'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}]",156.0,0.0725309,The mean (±SD) baseline WOMAC scores were 108.8±47.1 in the glucocorticoid injection group and 107.1±42.4 in the physical therapy group.,"[{'ForeName': 'Gail D', 'Initials': 'GD', 'LastName': 'Deyle', 'Affiliation': 'From Brooke Army Medical Center (G.D.D., S.C.A., N.W.G., D.I.D., D.I.R.), the Special Warfare Training Wing, U.S. Air Force (B.R.H.), and the University of the Incarnate Word (E.J.P.) - all in San Antonio, TX; the College of Allied Health Sciences, University of Cincinnati, Cincinnati (C.S.A.); and Madigan Army Medical Center, Tacoma, WA (D.I.R.).'}, {'ForeName': 'Chris S', 'Initials': 'CS', 'LastName': 'Allen', 'Affiliation': 'From Brooke Army Medical Center (G.D.D., S.C.A., N.W.G., D.I.D., D.I.R.), the Special Warfare Training Wing, U.S. Air Force (B.R.H.), and the University of the Incarnate Word (E.J.P.) - all in San Antonio, TX; the College of Allied Health Sciences, University of Cincinnati, Cincinnati (C.S.A.); and Madigan Army Medical Center, Tacoma, WA (D.I.R.).'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Allison', 'Affiliation': 'From Brooke Army Medical Center (G.D.D., S.C.A., N.W.G., D.I.D., D.I.R.), the Special Warfare Training Wing, U.S. Air Force (B.R.H.), and the University of the Incarnate Word (E.J.P.) - all in San Antonio, TX; the College of Allied Health Sciences, University of Cincinnati, Cincinnati (C.S.A.); and Madigan Army Medical Center, Tacoma, WA (D.I.R.).'}, {'ForeName': 'Norman W', 'Initials': 'NW', 'LastName': 'Gill', 'Affiliation': 'From Brooke Army Medical Center (G.D.D., S.C.A., N.W.G., D.I.D., D.I.R.), the Special Warfare Training Wing, U.S. Air Force (B.R.H.), and the University of the Incarnate Word (E.J.P.) - all in San Antonio, TX; the College of Allied Health Sciences, University of Cincinnati, Cincinnati (C.S.A.); and Madigan Army Medical Center, Tacoma, WA (D.I.R.).'}, {'ForeName': 'Benjamin R', 'Initials': 'BR', 'LastName': 'Hando', 'Affiliation': 'From Brooke Army Medical Center (G.D.D., S.C.A., N.W.G., D.I.D., D.I.R.), the Special Warfare Training Wing, U.S. Air Force (B.R.H.), and the University of the Incarnate Word (E.J.P.) - all in San Antonio, TX; the College of Allied Health Sciences, University of Cincinnati, Cincinnati (C.S.A.); and Madigan Army Medical Center, Tacoma, WA (D.I.R.).'}, {'ForeName': 'Evan J', 'Initials': 'EJ', 'LastName': 'Petersen', 'Affiliation': 'From Brooke Army Medical Center (G.D.D., S.C.A., N.W.G., D.I.D., D.I.R.), the Special Warfare Training Wing, U.S. Air Force (B.R.H.), and the University of the Incarnate Word (E.J.P.) - all in San Antonio, TX; the College of Allied Health Sciences, University of Cincinnati, Cincinnati (C.S.A.); and Madigan Army Medical Center, Tacoma, WA (D.I.R.).'}, {'ForeName': 'Douglas I', 'Initials': 'DI', 'LastName': 'Dusenberry', 'Affiliation': 'From Brooke Army Medical Center (G.D.D., S.C.A., N.W.G., D.I.D., D.I.R.), the Special Warfare Training Wing, U.S. Air Force (B.R.H.), and the University of the Incarnate Word (E.J.P.) - all in San Antonio, TX; the College of Allied Health Sciences, University of Cincinnati, Cincinnati (C.S.A.); and Madigan Army Medical Center, Tacoma, WA (D.I.R.).'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Rhon', 'Affiliation': 'From Brooke Army Medical Center (G.D.D., S.C.A., N.W.G., D.I.D., D.I.R.), the Special Warfare Training Wing, U.S. Air Force (B.R.H.), and the University of the Incarnate Word (E.J.P.) - all in San Antonio, TX; the College of Allied Health Sciences, University of Cincinnati, Cincinnati (C.S.A.); and Madigan Army Medical Center, Tacoma, WA (D.I.R.).'}]",The New England journal of medicine,['10.1056/NEJMoa1905877'] 129,32291702,Randomized Controlled Trial Comparing the Outcomes of Enhanced Recovery After Surgery and Standard Recovery Pathways in Laparoscopic Sleeve Gastrectomy.,"PURPOSE The enhanced recovery after surgery (ERAS) pathway is an evidence-based perioperative pathway that results in less pain, earlier recovery, and lower complication rates. Studies to prove their efficacy over standard recovery pathways in the Indian population are scarce. Our study intends to compare the outcomes of these pathways in the Indian community focusing on hospital stay, postoperative pain, and time for rescue analgesia. MATERIALS AND METHODS This is a single-blinded RCT involving 112 patients who underwent laparoscopic sleeve gastrectomy (LSG). The groups were divided into ERAS and standard pathway arms by closed envelope technique. The primary outcome was the length of hospital stay, while the secondary outcomes included pain score; postoperative nausea, and vomiting (PONV); time for rescue analgesia; and ambulation. RESULTS Of 112 patients included, 56 were allocated in the ERAS group, and the remaining 56 were included in the standard pathway group. We found no significant differences in the baseline characteristics between the two groups. Mean hospital stay was significantly lower in the ERAS group compared to the standard group (p = 0.003). In comparison to the standard group, ERAS patients were ambulated early, and the difference was highly significant (p < 0.001). Pain scores between the two groups showed a significant difference during the 4th hour and 8th hour. We also found a significant variation between the time for first rescue analgesia and the two groups (p < 0.001). CONCLUSION Patients who followed ERAS protocol were found to have shortened hospital stay, decreased pain, early ambulation, and reduced need for rescue analgesia. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03191318.",2020,Mean hospital stay was significantly lower in the ERAS group compared to the standard group (p = 0.003).,"['Of 112 patients included, 56 were allocated in the ERAS group, and the remaining 56 were included in the standard pathway group', '112 patients who underwent']","['ERAS', 'ERAS and standard pathway arms by closed envelope technique', 'laparoscopic sleeve gastrectomy (LSG', 'Laparoscopic Sleeve Gastrectomy']","['length of hospital stay', 'pain score; postoperative nausea, and vomiting (PONV); time for rescue analgesia; and ambulation', 'Pain scores', 'Mean hospital stay', 'shortened hospital stay, decreased pain, early ambulation, and reduced need for rescue analgesia', 'hospital stay, postoperative pain, and time for rescue analgesia']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013457', 'cui_str': 'Ambulation, Early'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",112.0,0.0908106,Mean hospital stay was significantly lower in the ERAS group compared to the standard group (p = 0.003).,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Prabhakaran', 'Affiliation': 'Department of Bariatric and Metabolic Surgery, GEM Hospital & Research Center, Coimbatore, Tamil Nadu, 641045, India.'}, {'ForeName': 'Shivanshu', 'Initials': 'S', 'LastName': 'Misra', 'Affiliation': 'Department of Bariatric and Metabolic Surgery, GEM Hospital & Research Center, Coimbatore, Tamil Nadu, 641045, India.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Magila', 'Affiliation': 'Department of Bariatric and Metabolic Surgery, GEM Hospital & Research Center, Coimbatore, Tamil Nadu, 641045, India.'}, {'ForeName': 'S Saravana', 'Initials': 'SS', 'LastName': 'Kumar', 'Affiliation': 'Department of Bariatric and Metabolic Surgery, GEM Hospital & Research Center, Coimbatore, Tamil Nadu, 641045, India.'}, {'ForeName': 'Sudarsan', 'Initials': 'S', 'LastName': 'Kasthuri', 'Affiliation': 'Department of Bariatric and Metabolic Surgery, GEM Hospital & Research Center, Coimbatore, Tamil Nadu, 641045, India.'}, {'ForeName': 'Chinnusamy', 'Initials': 'C', 'LastName': 'Palanivelu', 'Affiliation': 'Department of Bariatric and Metabolic Surgery, GEM Hospital & Research Center, Coimbatore, Tamil Nadu, 641045, India.'}, {'ForeName': 'P Praveen', 'Initials': 'PP', 'LastName': 'Raj', 'Affiliation': 'Department of Bariatric and Metabolic Surgery, GEM Hospital & Research Center, Coimbatore, Tamil Nadu, 641045, India. praveenraj@me.com.'}]",Obesity surgery,['10.1007/s11695-020-04585-2'] 130,31691829,When does prone sleeping improve cardiorespiratory status in preterm infants in the NICU?,"STUDY OBJECTIVES Preterm infants undergoing intensive care are often placed prone to improve respiratory function. Current clinical guidelines recommend preterm infants are slept supine from 32 weeks' postmenstrual age, regardless of gestational age at birth. However, respiratory function is also related to gestational and chronological ages and is affected by sleep state. We aimed to identify the optimal timing for adopting the supine sleeping position in preterm infants, using a longitudinal design assessing the effects of sleep position and state on cardiorespiratory stability. METHODS Twenty-three extremely (24-28 weeks' gestation) and 33 very preterm (29-34 weeks' gestation) infants were studied weekly from birth until discharge, in both prone and supine positions, in quiet and active sleep determined by behavioral scoring. Bradycardia (heart rate ≤100 bpm), desaturation (oxygen saturation ≤80%), and apnea (pause in respiratory rate ≥10 s) episodes were analyzed. RESULTS Prone positioning in extremely preterm infants reduced the frequency of bradycardias and desaturations and duration of desaturations. In very preterm infants, prone positioning only reduced the frequency of desaturations. The position-related effects were not related to postmenstrual age. Quiet sleep in both preterm groups was associated with fewer bradycardias and desaturations, and also reduced durations of bradycardia and desaturations in the very preterm group. CONCLUSIONS Cardiorespiratory stability is improved by the prone sleep position, predominantly in extremely preterm infants, and the improvements are not dependent on postmenstrual age. In very preterm infants, quiet sleep has a more marked effect than the prone position. This evidence should be considered in individualizing management of preterm infant positioning.",2020,Prone positioning in extremely preterm infants reduced the frequency of bradycardias and desaturations and duration of desaturations.,"[""Twenty-three extremely (24-28 weeks' gestation) and 33 very preterm"", 'Preterm infants undergoing intensive care', ""preterm infants are slept supine from 32 weeks' postmenstrual age, regardless of gestational age at birth"", 'preterm infants']",[],"['frequency of bradycardias and desaturations and duration of desaturations', 'cardiorespiratory status', 'Quiet sleep', 'durations of bradycardia and desaturations', 'frequency of desaturations', 'Bradycardia (heart rate ≤100 bpm), desaturation (oxygen saturation ≤80%), and apnea']","[{'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0085559'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0456129', 'cui_str': 'Length of gestation at birth'}]",[],"[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0234451', 'cui_str': 'Sleep, Slow-Wave'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}]",23.0,0.085315,Prone positioning in extremely preterm infants reduced the frequency of bradycardias and desaturations and duration of desaturations.,"[{'ForeName': 'Kelsee L', 'Initials': 'KL', 'LastName': 'Shepherd', 'Affiliation': 'The Ritchie Centre, Hudson Institute of Medical Research and Department of Paediatrics, Monash University, Melbourne, Australia.'}, {'ForeName': 'Stephanie R', 'Initials': 'SR', 'LastName': 'Yiallourou', 'Affiliation': 'The Ritchie Centre, Hudson Institute of Medical Research and Department of Paediatrics, Monash University, Melbourne, Australia.'}, {'ForeName': 'Alexsandria', 'Initials': 'A', 'LastName': 'Odoi', 'Affiliation': 'The Ritchie Centre, Hudson Institute of Medical Research and Department of Paediatrics, Monash University, Melbourne, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Yeomans', 'Affiliation': ""Monash Newborn, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Willis', 'Affiliation': ""Monash Newborn, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Rosemary S C', 'Initials': 'RSC', 'LastName': 'Horne', 'Affiliation': 'The Ritchie Centre, Hudson Institute of Medical Research and Department of Paediatrics, Monash University, Melbourne, Australia.'}, {'ForeName': 'Flora Y', 'Initials': 'FY', 'LastName': 'Wong', 'Affiliation': 'The Ritchie Centre, Hudson Institute of Medical Research and Department of Paediatrics, Monash University, Melbourne, Australia.'}]",Sleep,['10.1093/sleep/zsz256'] 131,31630201,Sleep in children with Smith-Magenis syndrome: a case-control actigraphy study.,"STUDY OBJECTIVES The objectives of the study were (1) to compare both actigraphy and questionnaire-assessed sleep quality and timing in children with Smith-Magenis syndrome (SMS) to a chronologically age-matched typically developing (TD) group and (2) to explore associations between age, nocturnal and diurnal sleep quality, and daytime behavior. METHODS Seven nights of actigraphy data were collected from 20 children with SMS (mean age 8.70; SD 2.70) and 20 TD children. Daily parent/teacher ratings of behavior and sleepiness were obtained. Mixed linear modeling was used to explore associations between total sleep time and daytime naps and behavior. RESULTS Sleep in children with SMS was characterized by shorter total sleep time (TST), extended night waking, shorter sleep onset, more daytime naps, and earlier morning waking compared to the TD group. Considerable inter-daily and inter-individual variability in sleep quality was found in the SMS group, so caution in generalizing results is required. An expected inverse association between age and TST was found in the TD group, but no significant association was found for the SMS group. No between-group differences in sleep hygiene practices were identified. A bidirectional negative association between TST and nap duration was found for the SMS group. In the SMS group, increased afternoon sleepiness was associated with increased irritability (p = .007) and overactivity (p = .005). CONCLUSION These findings evidence poor sleep quality in SMS and the need to implement evidence-based interventions in this population.",2020,"In the SMS group, increased afternoon sleepiness was associated with increased irritability (p = .007) and overactivity (p = .005). ","['Seven nights of actigraphy data were collected from 20 children with SMS (mean age 8.70; SD 2.70) and 20 TD children', 'children with Smith-Magenis syndrome', 'children with Smith-Magenis syndrome (SMS) to a chronologically age-matched typically developing (TD) group and (2) to explore associations between age, nocturnal and diurnal sleep quality, and daytime behavior', 'children with SMS']",[],"['total sleep time and daytime naps and behavior', 'Daily parent/teacher ratings of behavior and sleepiness', 'afternoon sleepiness', 'irritability', 'Sleep', 'sleep quality', 'overactivity', 'total sleep time (TST), extended night waking, shorter sleep onset, more daytime naps, and earlier morning waking', 'sleep hygiene practices']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0347795', 'cui_str': ""Reversed Colles' fracture""}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0067518', 'cui_str': 'N-(4-aminophenethyl)spiroperidol'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0439550', 'cui_str': 'Afternoon'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0474395', 'cui_str': 'Behavior showing increased motor activity'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}]",20.0,0.0214867,"In the SMS group, increased afternoon sleepiness was associated with increased irritability (p = .007) and overactivity (p = .005). ","[{'ForeName': 'Jayne', 'Initials': 'J', 'LastName': 'Trickett', 'Affiliation': 'Cerebra Centre for Neurodevelopmental Disorders, School of Psychology, University of Birmingham, Birmingham.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Oliver', 'Affiliation': 'Cerebra Centre for Neurodevelopmental Disorders, School of Psychology, University of Birmingham, Birmingham.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Heald', 'Affiliation': 'Cerebra Centre for Neurodevelopmental Disorders, School of Psychology, University of Birmingham, Birmingham.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Denyer', 'Affiliation': 'Cerebra Centre for Neurodevelopmental Disorders, School of Psychology, University of Birmingham, Birmingham.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Surtees', 'Affiliation': 'Cerebra Centre for Neurodevelopmental Disorders, School of Psychology, University of Birmingham, Birmingham.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Clarkson', 'Affiliation': 'The Huntercombe Group, Worcestershire.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gringras', 'Affiliation': ""Evelina London Children's Sleep Department, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Richards', 'Affiliation': 'Cerebra Centre for Neurodevelopmental Disorders, School of Psychology, University of Birmingham, Birmingham.'}]",Sleep,['10.1093/sleep/zsz260'] 132,31676910,Behavioral interventions for pediatric insomnia: one treatment may not fit all.,"STUDY OBJECTIVES Behavioral interventions for pediatric insomnia are cost-effective and benefit most families, but there is no evidence indicating which treatments are most suitable for specific patient populations. This randomized controlled trial evaluated the moderating role of infant separation anxiety in two brief interventions for infant sleep problems. METHODS Ninety-one infants aged 9-18 months (61% boys) with pediatric insomnia were randomized to either Checking-in, a Graduated extinction protocol which involves gradual separation from parents, or to the Camping-out intervention, in which parental presence is maintained. Sleep was measured using actigraphy and parent reports. Infant separation anxiety was observed in the laboratory. Assessments were completed at baseline, post-treatment and 6-month follow-up. RESULTS Improvement in sleep was demonstrated following both interventions and maintained at follow-up. Separation anxiety did not change significantly following treatment. Infant separation anxiety moderated treatment efficacy, with greater benefit for infants with high separation anxiety in the Camping-out compared to the Checking-in intervention. CONCLUSIONS This study provides support for considering infant separation anxiety in the effort to personalize treatment for pediatric insomnia. Pediatricians should incorporate evaluation of infant separation anxiety to assessment processes, and favor more gentle treatment approaches, such as Camping-out, over Graduated extinction for highly anxious infants. CLINICAL TRIAL REGISTRATION NCT01489215.",2020,"Infant separation anxiety moderated treatment efficacy, with greater benefit for infants with high separation anxiety in the Camping-out compared to the Checking-in intervention. ","['pediatric insomnia', 'highly anxious infants', 'Ninety-one infants aged 9-18 months (61% boys) with pediatric insomnia']","['Behavioral interventions', 'Graduated extinction protocol which involves gradual separation from parents, or to the Camping-out intervention']","['Sleep', 'Separation anxiety', 'Infant separation anxiety']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0870221', 'cui_str': 'Boys'}]","[{'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0439833', 'cui_str': 'Gradual (qualifier value)'}, {'cui': 'C0237868', 'cui_str': 'Separation'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0006811', 'cui_str': 'Camping'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0003477', 'cui_str': 'Separation Anxiety Disorder'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",91.0,0.0368492,"Infant separation anxiety moderated treatment efficacy, with greater benefit for infants with high separation anxiety in the Camping-out compared to the Checking-in intervention. ","[{'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kahn', 'Affiliation': 'School of Psychological Sciences, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Juda-Hanael', 'Affiliation': 'School of Psychological Sciences, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Efrat', 'Initials': 'E', 'LastName': 'Livne-Karp', 'Affiliation': 'School of Psychological Sciences, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Liat', 'Initials': 'L', 'LastName': 'Tikotzky', 'Affiliation': 'Department of Psychology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Anders', 'Affiliation': 'Department of Psychiatry at Brown University, Providence, RI.'}, {'ForeName': 'Avi', 'Initials': 'A', 'LastName': 'Sadeh', 'Affiliation': 'School of Psychological Sciences, Tel Aviv University, Tel Aviv, Israel.'}]",Sleep,['10.1093/sleep/zsz268'] 133,32245908,"BowelScope: Accuracy of Detection Using Endocuff Optimisation of Mucosal Abnormalities (the B-ADENOMA Study): a multicentre, randomised controlled flexible sigmoidoscopy trial.","OBJECTIVES Adenoma detection rate (ADR) is an important quality marker at lower GI endoscopy. Higher ADRs are associated with lower postcolonoscopy colorectal cancer rates. The English flexible sigmoidoscopy (FS) screening programme (BowelScope), offers a one-off FS to individuals aged 55 years. However, variation in ADR exists. Large studies have demonstrated improved ADR using Endocuff Vision (EV) within colonoscopy screening, but there are no studies within FS. We sought to test the effect of EV on ADR in a national FS screening population. DESIGN BowelScope: Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities was a multicentre, randomised controlled trial involving 16 English BowelScope screening centres. Individuals were randomised to Endocuff Vision-assisted BowelScope (EAB) or Standard BowelScope (SB). ADR, polyp detection rate (PDR), mean adenomas per procedure (MAP), polyp characteristics and location, participant experience, procedural time and adverse events were measured. Comparison of ADR within the trial with national BowelScope ADR was also undertaken. RESULTS 3222 participants were randomised (53% male) to receive EAB (n=1610) or SB (n=1612). Baseline demographics were comparable between arms. ADR in the EAB arm was 13.3% and that in the SB arm was 12.2% (p=0.353). No statistically significant differences were found in PDR, MAP, polyp characteristics or location, participant experience, complications or procedural characteristics. ADR in the SB control arm was 3.1% higher than the national ADR. CONCLUSION EV did not improve BowelScope ADR when compared with SB. ADR in both arms was higher than the national ADR. Where detection rates are already high, EV is unable to improve detection further. TRIAL REGISTRATION NUMBERS NCT03072472, ISRCTN30005319 and CPMS ID 33224.",2020,"No statistically significant differences were found in PDR, MAP, polyp characteristics or location, participant experience, complications or procedural characteristics.","['16 English BowelScope screening centres', 'individuals aged 55 years', '3222 participants']","['English flexible sigmoidoscopy (FS) screening programme (BowelScope', 'Endocuff Vision-assisted BowelScope (EAB) or Standard BowelScope (SB', 'EAB']","['mean adenomas per procedure (MAP), polyp characteristics and location, participant experience, procedural time and adverse events', 'PDR, MAP, polyp characteristics or location, participant experience, complications or procedural characteristics', 'BowelScope ADR', 'ADR', 'ADR, polyp detection rate (PDR']","[{'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0016234', 'cui_str': 'Flexible fiberoptic sigmoidoscopy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1845050', 'cui_str': 'Pigmentary Disorder, Reticulate, with Systemic Manifestations'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",16.0,0.16272,"No statistically significant differences were found in PDR, MAP, polyp characteristics or location, participant experience, complications or procedural characteristics.","[{'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'Rees', 'Affiliation': 'Northern Institute for Cancer Research, Newcastle University, Newcastle upon Tyne, UK Colin.Rees@newcastle.ac.uk.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Brand', 'Affiliation': 'North Wales Organisation for Randomised Trials in Health, Bangor University, Bangor, Gwynedd, UK.'}, {'ForeName': 'Wee Sing', 'Initials': 'WS', 'LastName': 'Ngu', 'Affiliation': 'Gastroenterology, South Tyneside NHS Foundation Trust, South Shields, South Tyneside, UK.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Stokes', 'Affiliation': 'Research, Gloucestershire Hospitals NHS Foundation Trust, Cheltenham, Gloucestershire, UK.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Hoare', 'Affiliation': 'North Wales Organisation for Randomised Trials in Health, Bangor University, Bangor, Gwynedd, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Totton', 'Affiliation': 'North Wales Organisation for Randomised Trials in Health, Bangor University, Bangor, Gwynedd, UK.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Bhandari', 'Affiliation': 'Gastroenterology, Portsmouth Hospitals NHS Trust, Portsmouth, Portsmouth, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Sharp', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Bastable', 'Affiliation': 'North Wales Organisation for Randomised Trials in Health, Bangor University, Bangor, Gwynedd, UK.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Rutter', 'Affiliation': 'Gastroenterology, North Tees and Hartlepool NHS Foundation Trust, Hartlepool, Hartlepool, UK.'}, {'ForeName': 'Ajay Mark', 'Initials': 'AM', 'LastName': 'Verma', 'Affiliation': 'Gastroenterology, Kettering General Hospital NHS Foundation Trust, Kettering, Northamptonshire, UK.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Lee', 'Affiliation': 'Gastroenterology Research, Northumbria Healthcare NHS Foundation Trust, North Shields, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Walls', 'Affiliation': 'Gastroenterology, South Tyneside NHS Foundation Trust, South Shields, South Tyneside, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Gut,['10.1136/gutjnl-2019-319621'] 134,31958526,"Buffered lidocaine 1%/epinephrine 1:100,000 with sodium bicarbonate (sodium hydrogen carbonate) in a 3:1 ratio is less painful than a 9:1 ratio: A double-blind, randomized, placebo-controlled, crossover trial.","BACKGROUND Neutralizing (buffering) lidocaine 1%/epinephrine 1:100,000 solution (Lido/Epi) with sodium hydrogen carbonate (NaHCO 3 ) (also called sodium bicarbonate) is widely used to reduce burning sensations during infiltration of Lido/Epi. Optimal mixing ratios have not been systematically investigated. OBJECTIVES To determine whether a Lido/Epi:NaHCO 3 mixing ratio of 3:1 (investigational medicinal product 1) causes less pain during infiltration than a mixing ratio of 9:1 (IMP2) or unbuffered Lido/Epi (IMP3). METHODS Double-blind, randomized, placebo-controlled, crossover trial (n = 2 × 24) with 4 investigational medicinal products (IMP1-4). RESULTS The 3:1 mixing ratio was significantly less painful than the 9:1 ratio (P = .044). Unbuffered Lido/Epi was more painful than the buffered Lido/Epi (P = .001 vs IMP1; P = .033 vs IMP2). IMP4 (NaCl 0.9% [placebo]) was more painful than any of the anesthetic solutions (P = .001 vs IMP1; P = .001 vs IMP2; P = .016 vs IMP3). In all cases, the anesthesia was effective for at least 3 hours. LIMITATIONS Results of this trial cannot be generalized to other local anesthetics such as prilocaine, bupivacaine, or ropivacaine, which precipitate with NaHCO 3 admixtures. CONCLUSIONS Lido/Epi-NaHCO 3 mixtures effectively reduce burning pain during infiltration. The 3:1 mixing ratio is significantly less painful than the 9:1 ratio. Reported findings are of high practical relevance, given the extensive use of local anesthesia today.",2020,The 3:1 mixing ratio was significantly less painful than the 9:1 ratio (p = 0.044).,[],"['lidocaine', 'prilocaine, bupivacaine', 'Lido/Epi-NaHCO 3 mixing ratio 3:1 (IMP1', 'IMP2) or unbuffered Lido/Epi (IMP3', '4 investigational medicinal products (IMP1-4', 'ropivacaine', 'epinephrine 1:100,000 solutions (Lido/Epi) with sodium hydrogen carbonate (NaHCO 3 ) (bicarbonate', 'placebo', 'IMP4 (NaCl 0.9%=placebo', 'Unbuffered Lido/Epi', 'sodium bicarbonate (hydrogen carbonate', 'epinephrine']",['burning pain'],[],"[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0033124', 'cui_str': 'Prilocaine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0267963', 'cui_str': 'Pancreatic Insufficiency'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0005367', 'cui_str': 'Hydrogen Carbonates'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}]","[{'cui': 'C0234230', 'cui_str': 'Pain, Burning'}]",,0.596982,The 3:1 mixing ratio was significantly less painful than the 9:1 ratio (p = 0.044).,"[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Vent', 'Affiliation': 'Department of Dermatology, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Surber', 'Affiliation': 'Department of Dermatology, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Nicole Tracy', 'Initials': 'NT', 'LastName': 'Graf Johansen', 'Affiliation': 'Graf Biostatistics, Winterthur, Switzerland.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Figueiredo', 'Affiliation': 'Hospital Pharmacy of the University Hospital Zurich, Schlieren, Switzerland.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Schönbächler', 'Affiliation': 'Institute of Psychology, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Imhof', 'Affiliation': 'Department of Dermatology, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Buset', 'Affiliation': 'Department of Dermatology, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Jürg', 'Initials': 'J', 'LastName': 'Hafner', 'Affiliation': 'Department of Dermatology, University Hospital of Zurich, Zurich, Switzerland. Electronic address: juerg.hafner@usz.ch.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.09.088'] 135,32107868,Evaluation of a Game Based Tele Rehabilitation Platform for In-Home Therapy of Hand-Arm Function Post Stroke: Feasibility Study.,"BACKGROUND There is a need for innovation to improve compliance and accessibility of rehabilitation programs for individuals with acquired brain injuries. A computer game-assisted tele-rehabilitation platform (GTP) has been developed to address this need. With the novel application of a miniature inertial computer mouse and taking advantage of the wide variety of computer games, the GTP can provide engaging exercises for rehabilitation of upper extremity motor skills. OBJECTIVE To determine the feasibility and acceptability of the game-assisted home exercise program for upper extremity rehabilitation for people with stroke. The treatment effect was also measured after 16 weeks of intervention. DESIGN A feasibility study. SETTING College of Rehabilitation Science, University of Manitoba. PARTICIPANTS Ten stroke clients. INTERVENTION Participants received three to four initial clinically supervised therapy sessions for training with the game assisted therapy program. Once trained, participants continued the program at the home for 16 weeks, four times per week. MAIN OUTCOME MEASURES Feasibility was evaluated based on retention rate and compliance. Semistructured interviews after the completion of the program were done to assess acceptability of the program. Quantitative analysis included (1) the Wolf Motor Function Test A and B and (2) a computerized performance-based assessment of specific object manipulation tasks that required a combination of finger, wrist, elbow and shoulder motion. RESULTS Findings demonstrated the feasibility and acceptability of the home tele-rehab program. Eight of the 10 participants fully complied with the 16-week exercise program. Two participants had difficulty with computer operations and did not complete the program. For the eight participants who completed the program, there was a substantial improvement from pre- to postintervention. CONCLUSION Although some difficulties with the technology were reported, the findings demonstrate feasible trial procedures, acceptable game-assisted task-oriented home training with a high compliance rate and positive outcomes. These findings and the theoretical evidence direct the next phase of a full-scale randomized controlled trial.",2021,"For the eight participants who completed the program, there was a substantial improvement pre- to post-intervention. ","['people with stroke', 'Ten stroke clients', '10 participants fully complied with the 16-wk exercise program', 'individuals with acquired brain injuries', 'home therapy of hand-arm function post stroke', 'College of Rehabilitation Science, University of Manitoba']","['Computer game-assisted Tele-Rehabilitation Platform (GTP', 'initial clinically supervised therapy sessions for training with the game assisted therapy program', 'game based Tele rehabilitation platform', 'game-assisted home exercise program']","['retention rate and compliance', 'Wolf Motor Function Test (WMFT', 'feasibility and acceptability']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0270611', 'cui_str': 'Brain Injuries'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0024726', 'cui_str': 'Manitoba'}]","[{'cui': 'C0870328', 'cui_str': 'Computer Games'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C4042802', 'cui_str': 'Tele-rehabilitation'}, {'cui': 'C0018353', 'cui_str': 'GTP'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program (regime/therapy)'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0325001', 'cui_str': 'Wolves'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0261368,"For the eight participants who completed the program, there was a substantial improvement pre- to post-intervention. ","[{'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Szturm', 'Affiliation': 'Department of Physical Therapy, College of Rehabilitation Sciences, University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Zoya', 'Initials': 'Z', 'LastName': 'Imran', 'Affiliation': 'Department of Physical Therapy, College of Rehabilitation Sciences, University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Pooyania', 'Affiliation': 'Department of Internal Medicine, Rady Faculty of Health Sciences, University of Manitoba, Attending Physician Stroke Rehabilitation Unit, Riverview Health Centre, Winnipeg, Canada.'}, {'ForeName': 'Anuprita', 'Initials': 'A', 'LastName': 'Kanitkar', 'Affiliation': 'Department of Physical Therapy, College of Rehabilitation Sciences, University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Bhuvan', 'Initials': 'B', 'LastName': 'Mahana', 'Affiliation': 'Department of Physical Therapy, College of Rehabilitation Sciences, University of Manitoba, Winnipeg, Canada.'}]","PM & R : the journal of injury, function, and rehabilitation",['10.1002/pmrj.12354'] 136,30805949,NGM282 Improves Liver Fibrosis and Histology in 12 Weeks in Patients With Nonalcoholic Steatohepatitis.,"NGM282, an engineered fibroblast growth factor 19 analogue, rapidly and significantly reduced liver fat content in a multicenter, randomized, double-blind, placebo-controlled study in patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH). However, it is unclear whether these changes would be accompanied by histological improvement. In this open-label study, we assessed the histological efficacy of NGM282 in patients with biopsy-confirmed nonalcoholic steatohepatitis. Paired liver biopsies from 43 patients who received subcutaneous NGM282 (1 mg, n = 24; 3 mg, n = 19) once daily for 12 weeks were evaluated blinded to time point, subject, and clinical information. At week 12, NGM282 significantly reduced nonalcoholic fatty liver disease activity score (NAS; -1.9; 95% confidence interval, -2.6 to -1.2; P < 0.001 in the 1 mg group; -2.2, -3.1 to -1.3; P < 0.001 in the 3 mg group) and fibrosis (-0.5; -0.9 to 0; P = 0.035 in the 3 mg group) scores. Overall, 50% and 63% of the patients receiving NGM282 1 mg or 3 mg, respectively, improved NAS by 2 or more points without fibrosis worsening. Of the patients receiving NGM282 1 mg or 3 mg, 25% and 42%, respectively, improved liver fibrosis by one stage or more without worsening of steatohepatitis. Treatment with NGM282 led to relative reductions in liver fat content (-58% and -67% in the 1 mg and 3 mg groups, respectively), corrected T1 (cT1; -8% and -9%), alanine aminotransferase (ALT) (-67% and -60%), aspartate aminotransferase (-57% and -52%), and fibrogenesis biomarkers neoepitope-specific N-terminal propeptide of type III collagen (Pro-C3; -22% and -33%) and enhanced liver fibrosis score (ELF; -3% and -6%) at week 12. Greater reductions in Pro-C3, ELF, and cT1, but not in liver fat content, 7alpha-hydroxy-4-cholesten-3-one, or ALT, were observed in histological responders than in nonresponders. Conclusion: In this open-label study, NGM282 improved the histological features of NASH in 12 weeks with significant reductions in NAS and fibrosis scores, accompanied by improvements in noninvasive imaging and serum markers.",2020,"At week 12, NGM282 significantly reduced nonalcoholic fatty liver disease activity score (NAS; -1.9; 95% confidence interval, -2.6 to -1.2; P < 0.001 in the 1 mg group; -2.2, -3.1 to -1.3; P < 0.001 in the 3 mg group) and fibrosis (-0.5; -0.9 to 0; P = 0.035 in the 3 mg group) scores.","['patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH', 'patients with biopsy-confirmed nonalcoholic steatohepatitis', 'Patients With Nonalcoholic Steatohepatitis', '43 patients who received']","['NGM282', 'subcutaneous NGM282', 'placebo']","['liver fat content, 7alpha-hydroxy-4-cholesten-3-one, or ALT', 'liver fat content', 'aspartate aminotransferase', 'noninvasive imaging and serum markers', 'Pro-C3, ELF, and cT1', 'NAS and fibrosis scores', 'liver fibrosis', 'Liver Fibrosis and Histology', 'nonalcoholic fatty liver disease activity score', 'alanine aminotransferase (ALT', 'enhanced liver fibrosis score', 'histological efficacy', 'fibrogenesis biomarkers neoepitope-specific N-terminal propeptide of type III collagen']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic Steatohepatitis'}]","[{'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0049730', 'cui_str': '7alpha-hydroxy-4-cholesten-3-one'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0162491', 'cui_str': 'Serum Markers'}, {'cui': 'C0071997', 'cui_str': 'C3 Precursor'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0239946', 'cui_str': 'Fibrosis, Liver'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0009332', 'cui_str': 'Collagen Type III'}]",,0.0898427,"At week 12, NGM282 significantly reduced nonalcoholic fatty liver disease activity score (NAS; -1.9; 95% confidence interval, -2.6 to -1.2; P < 0.001 in the 1 mg group; -2.2, -3.1 to -1.3; P < 0.001 in the 3 mg group) and fibrosis (-0.5; -0.9 to 0; P = 0.035 in the 3 mg group) scores.","[{'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Harrison', 'Affiliation': 'Radcliffe Department of Medicine, University of Oxford, UK.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Rossi', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, CA.'}, {'ForeName': 'Angelo H', 'Initials': 'AH', 'LastName': 'Paredes', 'Affiliation': 'San Antonio Military Medical Center, San Antonio, TX.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Trotter', 'Affiliation': 'Clinical Research and Education, Texas Digestive Disease Consultants, Dallas, TX.'}, {'ForeName': 'Mustafa R', 'Initials': 'MR', 'LastName': 'Bashir', 'Affiliation': 'Radiology and Medicine (Gastroenterology), Duke University, Durham, NC.'}, {'ForeName': 'Cynthia D', 'Initials': 'CD', 'LastName': 'Guy', 'Affiliation': 'Pathology, Duke University, Durham, NC.'}, {'ForeName': 'Rajarshi', 'Initials': 'R', 'LastName': 'Banerjee', 'Affiliation': 'Perspectum Diagnostics, Oxford, UK.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Jaros', 'Affiliation': 'Summit Analytical, Denver, CO.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Owers', 'Affiliation': 'Pinnacle Clinical Research, San Antonio, TX.'}, {'ForeName': 'Bryan A', 'Initials': 'BA', 'LastName': 'Baxter', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, CA.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Ling', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, CA.'}, {'ForeName': 'Alex M', 'Initials': 'AM', 'LastName': 'DePaoli', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, CA.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30590'] 137,32279184,Educational Video Addition to the Bariatric Surgery Informed Consent Process: a Randomized Controlled Trial.,"OBJECTIVE Bariatric surgery is not a risk-free procedure and requires lifelong patient compliance in the postoperative period. Although the risks involved in bariatric surgery and the importance of lifelong follow-ups in the postoperative period are explained to patients in detail through verbal and written informed consent, the strong desire for weight loss can sometimes cause patients and their families to be ignorant of the mentioned issues preoperatively. The objective of this study is to evaluate the effectiveness of preoperative informational videos at improving the comprehension of informed consent content in bariatric surgery candidates. MATERIALS AND METHODS A total of 74 bariatric surgery candidates were randomized into two groups. The first group was given a usual verbal-written informed consent. The second group got an additional informing video presentation informed consent, in addition to the usual verbal-written informed consent. Then, both groups got a questionnaire evaluating their knowledge of bariatric surgery informed consent. The correct response scores and their relationship with patient demographics were analyzed. RESULTS Both groups had similar demographic features. Video-presented group had higher scores in questionnaire (11.3 ± 2.3 versus 9.4 ± 1.7, p = 0.001). Subgroup analysis showed that health care workers (12.5 ± 1.9 versus 10.3 ± 2.2, p = 0.005) and university graduates (11.6 ± 2.4 versus 10.1 ± 2.1, p = 0.03) got better results in the questionnaire. In multivariate analysis, video-assisted informing was found to be the only independent variable for high questionnaire scores (p = 0.0001). CONCLUSIONS This study showed that video-assisted informed consent improves patients' comprehension prior to bariatric surgery. We recommend routine preoperative video-assisted informing for bariatric surgery candidates in addition to usual verbal-written informed consent.",2020,"Video-presented group had higher scores in questionnaire (11.3 ± 2.3 versus 9.4 ± 1.7, p = 0.001).","['74 bariatric surgery candidates', ""patients' comprehension prior to bariatric surgery""]","['usual verbal-written informed consent', 'additional informing video presentation informed consent, in addition to the usual verbal-written informed consent', 'video-assisted informed consent', 'preoperative informational videos']","['health care workers', 'high questionnaire scores']","[{'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",74.0,0.0360758,"Video-presented group had higher scores in questionnaire (11.3 ± 2.3 versus 9.4 ± 1.7, p = 0.001).","[{'ForeName': 'Kutay', 'Initials': 'K', 'LastName': 'Saglam', 'Affiliation': 'Department of Gastrointestinal Surgery, Inonu University, 44315, Malatya, Turkey. saglamk@gmail.com.'}, {'ForeName': 'Cuneyt', 'Initials': 'C', 'LastName': 'Kayaalp', 'Affiliation': 'Department of Gastrointestinal Surgery, Inonu University, 44315, Malatya, Turkey.'}, {'ForeName': 'Aydin', 'Initials': 'A', 'LastName': 'Aktas', 'Affiliation': 'Department of Gastrointestinal Surgery, Inonu University, 44315, Malatya, Turkey.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Sumer', 'Affiliation': 'Department of Gastrointestinal Surgery, Inonu University, 44315, Malatya, Turkey.'}]",Obesity surgery,['10.1007/s11695-020-04552-x'] 138,32271358,Association of 2-Year Progression Along the AREDS AMD Scale and Development of Late Age-Related Macular Degeneration or Loss of Visual Acuity: AREDS Report 41.,"Importance The Age-Related Eye Disease Study age-related macular degeneration (AREDS AMD) scale is designed to classify AMD severity. The present cohort study explored whether 2-year progression along this scale was useful for estimating the risk of future progression to late AMD or best-corrected visual acuity (BCVA) loss. Objective To assess whether 2-year progression along the AREDS AMD scale can be used to estimate the probability of long-term clinically meaningful outcome measures for clinical trials or epidemiologic studies. Design, Setting, and Participants Age-Related Eye Disease Study participants enrolled in a clinical trial of oral micronutrient supplements had annual color fundus photographs graded centrally using the AREDS AMD scale. Two-year progression (≥2-step and ≥3-step increases in AMD score between baseline and the 2-year study visit) was evaluated as a method of estimating the risk of long-term progression to late AMD or BCVA loss. The AREDS (1992-2001) was a randomized, placebo-controlled clinical trial based at 11 retinal specialty clinics in the United States. The dates of analysis in the present cohort study were November 1992 through November 2005. Main Outcomes and Measures Development of neovascular (NV) AMD, central geographic atrophy (CGA), any geographic atrophy (GA), or BCVA loss of at least 2 lines or at least 3 lines. Results Among 3868 participants in the AREDS free of late AMD at baseline, the mean (SD) age was 68.3 (5.0) years, and 2180 of 3868 (56.4%) were women. In the first 2 years after randomization to the AREDS, 669 of 7458 (9.0%) of eyes had at least 2-step 2-year progression, and 275 of 7458 (3.7%) of eyes had at least 3-step 2-year progression. In the 5-year follow-up period (years 2-7), 486 of 7223 (6.7%) of eyes developed NV AMD, 339 of 7253 (4.7%) developed CGA, 726 of 7246 (10.0%) developed any GA, 2622 of 7095 (37.0%) had at least 2-line BCVA loss, and 1494 of 7155 (20.9%) had at least 3-line BCVA loss. After adjusting for demographic and clinical confounders and stratifying by baseline AMD score, statistically significant associations were observed between at least 2-step and at least 3-step 2-year progression of AMD score and subsequent 5-year development of NV AMD: hazard ratios (HRs) ranged from 3.6 (99% CI, 2.4-5.2) to 19.4 (99% CI, 7.7-48.9). For CGA, HRs ranged from 2.6 (99% CI, 1.7-4.0) to 4.7 (99% CI, 2.5-8.9); the results were similar for any GA. For at least 2-line and at least 3-line BCVA loss, HRs ranged from 1.3 (99% CI, 1.0-1.7) to 2.8 (99% CI, 1.8-4.3). For all outcomes, at least 3-step 2-year progression had stronger associations than at least 2-step 2-year progression. These findings were also validated in the AREDS2 cohort. Conclusions and Relevance Two-year progression of AMD score was associated with progression to clinically meaningful anatomic (late AMD) and vision (≥2-line or ≥3-line loss) outcomes, suggesting that this scale may be useful for future clinical trials designed to slow the progression of AMD.",2020,"For all outcomes, at least 3-step 2-year progression had stronger associations than at least 2-step 2-year progression.","['Participants\n\n\nAge-Related Eye Disease Study participants enrolled in a clinical trial of', '3868 participants in the AREDS free of late AMD at baseline, the mean (SD) age was 68.3 (5.0) years, and 2180 of 3868 (56.4%) were women', '11 retinal specialty clinics in the United States']","['placebo', 'oral micronutrient supplements']","['least 2-line BCVA loss', 'Measures\n\n\nDevelopment of neovascular (NV) AMD, central geographic atrophy (CGA), any geographic atrophy (GA), or BCVA loss of at least 2 lines or at least 3 lines', 'AMD score', 'AMD score and subsequent 5-year development of NV AMD: hazard ratios (HRs', 'annual color fundus photographs graded centrally using the AREDS AMD scale', 'risk of future progression to late AMD or best-corrected visual acuity (BCVA) loss']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0015397', 'cui_str': 'Disorder of eye'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0017921', 'cui_str': 'Generalized glycogenosis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0017921', 'cui_str': 'Generalized glycogenosis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0016823', 'cui_str': 'Structure of fundus of eye'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}]",,0.0716089,"For all outcomes, at least 3-step 2-year progression had stronger associations than at least 2-step 2-year progression.","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Vitale', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Agrón', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Traci E', 'Initials': 'TE', 'LastName': 'Clemons', 'Affiliation': 'The Emmes Company, LLC, Rockville, Maryland.'}, {'ForeName': 'Tiarnan D L', 'Initials': 'TDL', 'LastName': 'Keenan', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Amitha', 'Initials': 'A', 'LastName': 'Domalpally', 'Affiliation': 'Fundus Photograph Reading Center, University of Wisconsin-Madison.'}, {'ForeName': 'Ronald P', 'Initials': 'RP', 'LastName': 'Danis', 'Affiliation': 'Fundus Photograph Reading Center, University of Wisconsin-Madison.'}, {'ForeName': 'Emily Y', 'Initials': 'EY', 'LastName': 'Chew', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.0824'] 139,32275191,IL (Interleukin)-1 Receptor Antagonist Increases Ang (Angiotensin [1-7]) and Decreases Blood Pressure in Obese Individuals.,"IL (Interleukin)-1 antagonism decreases blood pressure in obese individuals. The underlying mechanisms are unknown. Based on experimental data, we hypothesized an effect of IL-1 antagonism via modulation of the renin-angiotensin-aldosterone system. In this explorative study, we examined shorter- (2 days) and longer-term effects (4 weeks) of IL-1 antagonism (anakinra/Kineret) on renin-angiotensin system peptide profiles and on hemodynamic parameters assessed by noninvasive measurement in obese (body mass index ≥30 kg/m 2 ) individuals from 2 interventional trials (a prospective interventional trial [n=73] and a placebo controlled-double blinded interventional trial [n=67]). A total of 140 patients were included. Systolic blood pressure decreased after short-term (absolute difference -5.2 mm Hg [95% CI, -8.5 to -1.8]; P =0.0006) and after longer-term treatment with anakinra (absolute difference -3.9 mm Hg [95% CI, -7.59 to -0.21]; P =0.04), with no change in blood pressure in the placebo group. Upon IL-1 antagonism, equilibrium levels of Ang II (angiotensin II), Ang I, aldosterone, and renin remained unchanged. In contrast, Ang (1-7) peptide levels increased after 4 weeks (between-group difference 16.35 pmol/L [95% CI, 1.22-30.17], P =0.03), as well as the Ang (1-7)/Ang II ratio (between-group difference 0.42 [95% CI, 0.17-0.67], P =0.02) in comparison to placebo. Consistently, the stroke systemic vascular resistance index significantly decreased in the anakinra group (between-group difference of -62.65 dyn/sec per cm -5 per m 2 [95% CI, -116.94 to -18.36], P =0.008, consistent with a 25% decrease). IL-1 antagonism increased the vasodilatory Ang (1-7) peptide after 4 weeks of treatment in obese individuals, paralleled by a decrease in peripheral vascular resistance. These findings point to an IL-1 mediated blood pressure-lowering mechanism via modulation of Ang (1-7). Registration- URL: https://www.clinicaltrials.gov. Unique identifiers: NCT02227420 and NCT02672592.",2020,"IL-1 antagonism increased the vasodilatory Ang (1-7) peptide after 4 weeks of treatment in obese individuals, paralleled by a decrease in peripheral vascular resistance.","['A total of 140 patients were included', 'obese individuals', 'Obese Individuals', 'obese (body mass index ≥30 kg/m 2 ) individuals from 2 interventional trials (a prospective interventional trial [n=73] and a']","['IL (Interleukin)-1 Receptor Antagonist', 'IL (Interleukin)-1 antagonism', 'placebo', 'IL-1 antagonism (anakinra/Kineret']","['stroke systemic vascular resistance index', 'blood pressure', 'peripheral vascular resistance', 'Systolic blood pressure', 'Blood Pressure', 'IL-1 antagonism', 'IL-1 antagonism, equilibrium levels of Ang II (angiotensin II), Ang I, aldosterone, and renin', 'peptide levels']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}]","[{'cui': 'C0063710', 'cui_str': 'Interleukin 1 Receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}, {'cui': 'C1170364', 'cui_str': 'Kineret'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0456260', 'cui_str': 'Systemic vascular resistance index'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0051844', 'cui_str': 'Angiogenin'}, {'cui': 'C0003009', 'cui_str': 'angiotensin II'}, {'cui': 'C0002006', 'cui_str': 'Aldosterone'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}]",140.0,0.698881,"IL-1 antagonism increased the vasodilatory Ang (1-7) peptide after 4 weeks of treatment in obese individuals, paralleled by a decrease in peripheral vascular resistance.","[{'ForeName': 'Sandrine Andrea', 'Initials': 'SA', 'LastName': 'Urwyler', 'Affiliation': 'From the Department of Endocrinology, Diabetology and Metabolism (S.A.U., F.E., M.Y.D., M.C.-C.), University Hospital Basel, Switzerland.'}, {'ForeName': 'Fahim', 'Initials': 'F', 'LastName': 'Ebrahimi', 'Affiliation': 'From the Department of Endocrinology, Diabetology and Metabolism (S.A.U., F.E., M.Y.D., M.C.-C.), University Hospital Basel, Switzerland.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Burkard', 'Affiliation': 'Department of Clinical Research (S.A.U., F.E., T.B., P.S., B.M., M.Y.D., M.C.-C.), University Hospital Basel, Switzerland.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Schuetz', 'Affiliation': 'Department of Clinical Research (S.A.U., F.E., T.B., P.S., B.M., M.Y.D., M.C.-C.), University Hospital Basel, Switzerland.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Poglitsch', 'Affiliation': 'Attoquant Diagnostics GmbH, Campus-Vienna-Biocenter, Vienna, Austria (M.P.).'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Mueller', 'Affiliation': 'Department of Clinical Research (S.A.U., F.E., T.B., P.S., B.M., M.Y.D., M.C.-C.), University Hospital Basel, Switzerland.'}, {'ForeName': 'Marc Y', 'Initials': 'MY', 'LastName': 'Donath', 'Affiliation': 'From the Department of Endocrinology, Diabetology and Metabolism (S.A.U., F.E., M.Y.D., M.C.-C.), University Hospital Basel, Switzerland.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Christ-Crain', 'Affiliation': 'From the Department of Endocrinology, Diabetology and Metabolism (S.A.U., F.E., M.Y.D., M.C.-C.), University Hospital Basel, Switzerland.'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.119.13982'] 140,32277364,"Phase I, First-in-Human, Single and Multiple Ascending Dose- and Food-Effect Studies to Assess the Safety, Tolerability and Pharmacokinetics of a Novel Anti-hepatitis B Virus Drug, Bentysrepinine (Y101), in Healthy Chinese Subjects.","BACKGROUND AND OBJECTIVE Bentysrepinine (Y101), a derivative of repensine (a compound isolated from Dichondra repens Forst), is a novel phenylalanine dipeptide currently under development for the treatment of hepatitis B virus (HBV). The objectives of these studies were to assess the safety, tolerability and pharmacokinetics of bentysrepinine in healthy Chinese subjects. METHODS Two randomised, double-blind, placebo-controlled trials evaluated a single oral dose (50-900 mg, study 01) and multiple doses (300 mg and 600 mg, study 02), and a randomised, open, crossover food-effect study (600 mg, study 03) of bentysrepinine was established. Safety and tolerability were assessed by adverse event (AE) reporting, clinical laboratory tests, physical examinations, vital sign monitoring and electrocardiogram (ECG). Plasma, urine and faecal samples were analysed using validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methods to investigate the pharmacokinetics of bentysrepinine. RESULTS Ninety-four subjects were enrolled, and bentysrepinine was well tolerated. Mild and reversible AEs occurred for single and multiple oral doses between 50 and 900 mg. The most common adverse effects were increased alanine aminotransferase (ALT) and aspartate transaminase (AST). Other clinically significant AEs included nausea and elevated urine leukocytes, urine red blood cells, transaminase, creatine kinase, total cholesterol, triglycerides, and low-density cholesterol. There were no clinically significant changes in the ECG, vital signs or laboratory assessments during the studies. The maximum tolerated dose (MTD) was not reached in the dose escalation study. Bentysrepinine was rapidly absorbed and metabolised with a mean time to reach maximum concentration (T max ) between 1-2 h and a mean terminal elimination half-life (t 1/2 ) of approximately 1-3 h. In the single ascending dose study, the exposure including the area under the concentration-time curve (AUC) and the maximum plasma concentration (C max ) of bentysrepinine generally increased in a dose-dependent but not dose-proportional manner in the 50-900 mg dose range. The urinary excretion and faecal excretion of unchanged bentysrepinine were 2.98% and 4.58% of the total dose, respectively. In the multiple-dose study, no accumulation was found after repeated administration at the 300 mg and 600 mg dose levels. The food-effect study using a 600 mg single dose showed that food intake has an obvious effect on the absorption of bentysrepinine from tablets. No experimental differences were found based on sex. CONCLUSION Bentysrepinine exhibited acceptable safety and tolerability in healthy subjects in the dose range of 50-900 mg in both single- and multiple-dose studies. The drug did not exhibit linear pharmacokinetic characteristics. No accumulation was observed after the administration of multiple 300 and 600 mg doses. Bentysrepinine is extensively metabolised in the body. Food may increase its bioavailability. TRIALS REGISTRATION CFDA registration numbers CTR20160096, CTR20160094, and CTR20140543 (www.chinadrugtrials.org.cn).",2020,Bentysrepinine was rapidly absorbed and metabolised with a mean time to reach maximum concentration (T max ) between 1-2 h and a mean terminal elimination half-life (t 1/2 ) of approximately 1-3 h.,"['healthy Chinese subjects', 'healthy subjects', 'Ninety-four subjects were enrolled, and', 'Healthy Chinese Subjects']","['bentysrepinine', 'Bentysrepinine', 'Novel Anti-hepatitis B Virus Drug, Bentysrepinine', 'placebo']","['bioavailability', 'safety, tolerability and pharmacokinetics', 'Safety, Tolerability and Pharmacokinetics', 'tolerated', 'maximum tolerated dose (MTD', 'Safety and tolerability', 'urinary excretion and faecal excretion of unchanged bentysrepinine', 'ECG, vital signs or laboratory assessments', 'concentration-time curve (AUC) and the maximum plasma concentration (C max ) of bentysrepinine', 'Plasma, urine and faecal samples', 'acceptable safety and tolerability', 'nausea and elevated urine leukocytes, urine red blood cells, transaminase, creatine kinase, total cholesterol, triglycerides, and low-density cholesterol', 'adverse event (AE) reporting, clinical laboratory tests, physical examinations, vital sign monitoring and electrocardiogram (ECG', 'Mild and reversible AEs', 'alanine aminotransferase (ALT) and aspartate transaminase (AST']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C3493298', 'cui_str': 'N-(N-benzoyl-O-(2-dimethylaminoethyl)-L-tyrosyl)-L-phenylalaninol'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0752079', 'cui_str': 'Maximal Tolerated Dose'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0442739', 'cui_str': 'No status change'}, {'cui': 'C3493298', 'cui_str': 'N-(N-benzoyl-O-(2-dimethylaminoethyl)-L-tyrosyl)-L-phenylalaninol'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0555120', 'cui_str': 'Urine micr.:leukocytes present'}, {'cui': 'C0427827', 'cui_str': 'Urine: red - blood'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4505474', 'cui_str': 'Clinical Laboratory Tests'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}]",94.0,0.106305,Bentysrepinine was rapidly absorbed and metabolised with a mean time to reach maximum concentration (T max ) between 1-2 h and a mean terminal elimination half-life (t 1/2 ) of approximately 1-3 h.,"[{'ForeName': 'Xiaoxue', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Clinical Pharmacology, The First Affiliated Hospital of Soochow University, No. 899, Pinghai Street, Suzhou, 215006, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Xue', 'Affiliation': 'Department of Clinical Pharmacology, The First Affiliated Hospital of Soochow University, No. 899, Pinghai Street, Suzhou, 215006, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Clinical Pharmacology, The First Affiliated Hospital of Soochow University, No. 899, Pinghai Street, Suzhou, 215006, China.'}, {'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Xu', 'Affiliation': 'Department of Pharmaceutics, College of Pharmaceutical Science, Soochow University, Suzhou, China.'}, {'ForeName': 'Shichao', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmaceutics, College of Pharmaceutical Science, Soochow University, Suzhou, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': 'Department of Clinical Pharmacology, The First Affiliated Hospital of Soochow University, No. 899, Pinghai Street, Suzhou, 215006, China.'}, {'ForeName': 'Xiaoliang', 'Initials': 'X', 'LastName': 'Ding', 'Affiliation': 'Department of Clinical Pharmacology, The First Affiliated Hospital of Soochow University, No. 899, Pinghai Street, Suzhou, 215006, China.'}, {'ForeName': 'Linsheng', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Clinical Pharmacology, The First Affiliated Hospital of Soochow University, No. 899, Pinghai Street, Suzhou, 215006, China.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'Department of Clinical Pharmacology, The First Affiliated Hospital of Soochow University, No. 899, Pinghai Street, Suzhou, 215006, China.'}, {'ForeName': 'Lifang', 'Initials': 'L', 'LastName': 'Qian', 'Affiliation': 'Department of Clinical Pharmacology, The First Affiliated Hospital of Soochow University, No. 899, Pinghai Street, Suzhou, 215006, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Xia', 'Affiliation': 'Bailing Enterprise Group Pharmaceutical Co., Ltd., Guizhou, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Jiang', 'Affiliation': 'Bailing Enterprise Group Pharmaceutical Co., Ltd., Guizhou, China.'}, {'ForeName': 'Chenrong', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Department of Clinical Pharmacology, The First Affiliated Hospital of Soochow University, No. 899, Pinghai Street, Suzhou, 215006, China. chrishuangcr@163.com.'}, {'ForeName': 'Liyan', 'Initials': 'L', 'LastName': 'Miao', 'Affiliation': 'Department of Clinical Pharmacology, The First Affiliated Hospital of Soochow University, No. 899, Pinghai Street, Suzhou, 215006, China. miaoliyan@suda.edu.cn.'}]",Clinical drug investigation,['10.1007/s40261-020-00909-3'] 141,31652094,Randomized Trial of Lenalidomide Versus Observation in Smoldering Multiple Myeloma.,"PURPOSE Observation is the current standard of care for smoldering multiple myeloma. We hypothesized that early intervention with lenalidomide could delay progression to symptomatic multiple myeloma. METHODS We conducted a randomized trial that assessed the efficacy of single-agent lenalidomide compared with observation in patients with intermediate- or high-risk smoldering multiple myeloma. Lenalidomide was administered orally at a dose of 25 mg on days 1 to 21 of a 28-day cycle. The primary end point was progression-free survival, with disease progression requiring the development of end-organ damage attributable to multiple myeloma and biochemical progression. RESULTS One hundred eighty-two patients were randomly assigned-92 patients to the lenalidomide arm and 90 to the observation arm. Median follow-up is 35 months. Response to therapy was observed in 50% (95% CI, 39% to 61%) of patients in the lenalidomide arm, with no responses in the observation arm. Progression-free survival was significantly longer with lenalidomide compared with observation (hazard ratio, 0.28; 95% CI, 0.12 to 0.62; P = .002). One-, 2-, and 3-year progression-free survival was 98%, 93%, and 91% for the lenalidomide arm versus 89%, 76%, and 66% for the observation arm, respectively. Only six deaths have been reported, two in the lenalidomide arm versus four in the observation arm (hazard ratio for death, 0.46; 95% CI, 0.08 to 2.53). Grade 3 or 4 nonhematologic adverse events occurred in 25 patients (28%) on lenalidomide. CONCLUSION Early intervention with lenalidomide in smoldering multiple myeloma significantly delays progression to symptomatic multiple myeloma and the development of end-organ damage.",2020,"Progression-free survival was significantly longer with lenalidomide compared with observation (hazard ratio, 0.28; 95% CI, 0.12 to 0.62; ","['Smoldering Multiple Myeloma', 'patients with intermediate- or high-risk smoldering multiple myeloma', 'One hundred eighty-two patients were randomly assigned-92 patients to the lenalidomide arm and 90 to the observation arm']","['single-agent lenalidomide', 'lenalidomide', 'Lenalidomide']","['progression-free survival, with disease progression requiring the development of end-organ damage attributable to multiple myeloma and biochemical progression', '3-year progression-free survival', 'Progression-free survival', 'Grade 3 or 4 nonhematologic adverse events']","[{'cui': 'C1531608', 'cui_str': 'Asymptomatic Multiple Myeloma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",182.0,0.116764,"Progression-free survival was significantly longer with lenalidomide compared with observation (hazard ratio, 0.28; 95% CI, 0.12 to 0.62; ","[{'ForeName': 'Sagar', 'Initials': 'S', 'LastName': 'Lonial', 'Affiliation': 'Emory University, Atlanta, GA.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Jacobus', 'Affiliation': 'Dana Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Fonseca', 'Affiliation': 'Mayo Clinic, Scottsdale, AZ.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Weiss', 'Affiliation': 'ThedaCare Cancer Center, Appleton, WI.'}, {'ForeName': 'Shaji', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Robert Z', 'Initials': 'RZ', 'LastName': 'Orlowski', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Kaufman', 'Affiliation': 'Emory University, Atlanta, GA.'}, {'ForeName': 'Abdulraheem M', 'Initials': 'AM', 'LastName': 'Yacoub', 'Affiliation': 'University of Kansas Cancer Center, Westwood, KS.'}, {'ForeName': 'Francis K', 'Initials': 'FK', 'LastName': 'Buadi', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': ""O'Brien"", 'Affiliation': 'MetroHealth Medical Center, Cleveland, OH.'}, {'ForeName': 'Jeffrey V', 'Initials': 'JV', 'LastName': 'Matous', 'Affiliation': 'Colorado Blood Cancer Institute and Sarah Cannon Research Institute, Denver, CO.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Anderson', 'Affiliation': 'Park Nicollet Clinic, Saint Louis Park, MN.'}, {'ForeName': 'Robert V', 'Initials': 'RV', 'LastName': 'Emmons', 'Affiliation': 'University of Louisville, Louisville, KY.'}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Mahindra', 'Affiliation': 'Scripps Clinic Torrey Pines, La Jolla, CA.'}, {'ForeName': 'Lynne I', 'Initials': 'LI', 'LastName': 'Wagner', 'Affiliation': 'Wake Forest University Health Sciences, Winston-Salem, NC.'}, {'ForeName': 'Madhav V', 'Initials': 'MV', 'LastName': 'Dhodapkar', 'Affiliation': 'Emory University, Atlanta, GA.'}, {'ForeName': 'S Vincent', 'Initials': 'SV', 'LastName': 'Rajkumar', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01740'] 142,32165032,"Efficacy of Parent-Delivered, Home-Based Therapy for Tics.","BACKGROUND Although behavioral therapy is an effective approach to reduce tics in children and adults, there is an insufficient availability and accessibility of behavioral therapy in the community. OBJECTIVE The goal of the study was to test the clinical efficacy of home-based, parent-provided behavioral therapy in children with Tourette syndrome aged seven to 13 years. METHOD An instructional habit reversal training-based video and guide was developed for use by parents. Eligible families, in this 10-week study, were enrolled in either a home-based therapy (DVD) group (received disk and written instructions) or an in-person therapist group (had scheduled visits with the therapist). Outcome scales included the Yale Global Tic Severity Scale, both the total Tic Severity Score and total Global Severity Score, and the parent report of Clinical Global Impressions of Improvement. RESULTS Forty-four children (mean age = 10.21 ± 1.69 years) were enrolled into either the DVD (n = 33) or in-person therapist (n = 11) groups. Eighteen completed the study-eight in the DVD and 10 in the in-person therapist group. Outcome measures showed significant reductions in Yale Global Tic Severity Scale change ratios: mean improvement on the Tic Severity Score was DVD 32.4% (P < 0.001) and in-person therapist 26.6% (P = 0.01); and for the Global Severity Score, DVD 33.7% (P < 0.001) and in-person therapist 26.7% (P < 0.001). CONCLUSIONS Home-based, parent-administered habit reversal training behavioral therapy is efficacious for reducing tics in children. Telephone contacts early in the DVD treatment course might reduce the number of dropouts.",2020,"Outcome measures showed significant reductions in Yale Global Tic Severity Scale change ratios: mean improvement on the Tic Severity Score was DVD 32.4% (P < 0.001) and in-person therapist 26.6% (P = 0.01); and for the Global Severity Score, DVD 33.7% (P ","['children and adults', 'children', 'Tics', 'Forty-four children (mean age\xa0=\xa010.21\xa0±\xa01.69\xa0years) were enrolled into either the DVD (n\xa0=\xa033) or in-person therapist (n\xa0=\xa011) groups', 'Eighteen completed the study-eight in the DVD and 10 in the in-person therapist group', 'children with Tourette syndrome aged seven to 13\xa0years']","['home-based therapy (DVD) group (received disk and written instructions) or an in-person therapist group (had scheduled visits with the therapist', 'home-based, parent-provided behavioral therapy', 'Parent-Delivered, Home-Based Therapy']","['Yale Global Tic Severity Scale change ratios: mean improvement on the Tic Severity Score', 'Yale Global Tic Severity Scale, both the total Tic Severity Score and total Global Severity Score, and the parent report of Clinical Global Impressions of Improvement']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0040517', 'cui_str': 'Chronic Motor and Vocal Tic Disorder'}, {'cui': 'C0205453', 'cui_str': '7'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}]","[{'cui': 'C4720888', 'cui_str': 'Yale global tic severity scale (assessment scale)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0278076', 'cui_str': 'Habit Chorea'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",44.0,0.0842714,"Outcome measures showed significant reductions in Yale Global Tic Severity Scale change ratios: mean improvement on the Tic Severity Score was DVD 32.4% (P < 0.001) and in-person therapist 26.6% (P = 0.01); and for the Global Severity Score, DVD 33.7% (P ","[{'ForeName': 'Harvey S', 'Initials': 'HS', 'LastName': 'Singer', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland; Kennedy Krieger Institute, Baltimore, Maryland. Electronic address: hsinger@jhmi.edu.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'McDermott', 'Affiliation': 'Kennedy Krieger Institute, Baltimore, Maryland.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Ferenc', 'Affiliation': 'Kennedy Krieger Institute, Baltimore, Maryland.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Specht', 'Affiliation': 'Weill-Cornell Medical School, New York, New York.'}, {'ForeName': 'E Mark', 'Initials': 'EM', 'LastName': 'Mahone', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland; Kennedy Krieger Institute, Baltimore, Maryland.'}]",Pediatric neurology,['10.1016/j.pediatrneurol.2019.12.015'] 143,32279367,"An extension of the RITUX-ERAH study, multicenter randomized clinical trial comparing rituximab to placebo in acute antibody-mediated rejection after renal transplantation.","The treatment of active antibody-mediated rejection (ABMR) is still a matter of debate, the place of rituximab remaining controversial. The French multicenter double-blind RITUX-ERAH study included 38 patients with ABMR in the first year of renal transplantation. All patients received plasma exchanges, intravenous immunoglobulins, and corticosteroids and were randomly assigned rituximab or placebo infusion at day 5. Additional rituximab infusions were allowed. In the intention-to-treat analysis, 12-month graft survival and renal function were not different between the rituximab and placebo groups. Long-term data are needed to conclude. Evaluation of the 7-year outcomes of the RITUX-ERAH study patients according to the rituximab or placebo treatment received. Eleven patients received placebo and 27 at least one infusion of rituximab. Seven years after ABMR, death-censored kidney allograft survival and renal function were not different between the groups. The evolution of anti-HLA sensitization was similar. There was no statistically significant difference in the incidence of infectious or neoplastic complications, but to be noted, seven cancers developed in six patients treated with rituximab (mean period of 44 months post-ABMR). In this cohort, there was no benefit 7 years after ABMR of rituximab in addition to plasma exchanges, intravenous immunoglobulins, and steroids.",2020,"In the intention-to-treat analysis, 12-month graft survival and renal function were not different between the rituximab and placebo groups.","['38 patients with ABMR in the first year of renal transplantation', 'acute antibody-mediated rejection after renal transplantation']","['plasma exchanges, intravenous immunoglobulins, corticosteroids and were randomly assigned rituximab or placebo', 'rituximab or placebo', 'placebo', 'rituximab']","['death-censored kidney allograft survival and renal function', 'graft survival and renal function', 'incidence of infectious or neoplastic complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1608421', 'cui_str': 'Antibody-mediated rejection'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0032113', 'cui_str': 'Plasma exchange'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",38.0,0.401729,"In the intention-to-treat analysis, 12-month graft survival and renal function were not different between the rituximab and placebo groups.","[{'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Bailly', 'Affiliation': 'Department of Nephrology, Hypertension, Dialysis and Kidney Transplantation, University hospital of Tours, Tours, France.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Ville', 'Affiliation': 'Institut de Transplantation Urologie Néphrologie (ITUN), CHU Nantes and Centre de Recherche en Transplantation et Immunologie UMR1064, INSERM, Université de Nantes, Nantes, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Blancho', 'Affiliation': 'Institut de Transplantation Urologie Néphrologie (ITUN), CHU Nantes and Centre de Recherche en Transplantation et Immunologie UMR1064, INSERM, Université de Nantes, Nantes, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Morelon', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, University hospital of Lyon Edouard Herriot, Lyon, France.'}, {'ForeName': 'Jamal', 'Initials': 'J', 'LastName': 'Bamoulid', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, University hospital of Besançon, Besançon, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Caillard', 'Affiliation': 'Nephrology-Transplantation Department, University Hospital, Strasbourg, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Chatelet', 'Affiliation': 'Centre Universitaire des Maladies Rénales, CHU de Caen, Caen, France.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Malvezzi', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, University hospital of Grenoble, Grenoble, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Tourret', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, Assistance Publique - Hôpitaux de Paris, Pitié Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Vuiblet', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, University hospital of Reims, Reims, France.'}, {'ForeName': 'Dany', 'Initials': 'D', 'LastName': 'Anglicheau', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, Assistance Publique - Hôpitaux de Paris, Necker Hospital, Paris, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Bertrand', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, University hospital of Rouen, Rouen, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Grimbert', 'Affiliation': 'Service de Néphrologie et Transplantation, Pôle Cancérologie-Immunité-Transplantation-Infectiologie et Unité INSERM 955, CHU Henri Mondor et Université Paris-Est, Creteil, France.'}, {'ForeName': 'Fadi', 'Initials': 'F', 'LastName': 'Haidar', 'Affiliation': 'Department of Hemodialysis, CHT Noumea, Noumea, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Hazzan', 'Affiliation': 'Service de Néphrologie, CHU Lille and Inserm U995, Lille, France.'}, {'ForeName': 'Nassim', 'Initials': 'N', 'LastName': 'Kamar', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, University Hospital of Toulouse, Toulouse, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Merville', 'Affiliation': 'Department of Nephrology, Transplantation, Dialysis and Apheresis, Bordeaux University Hospital, Bordeaux, France.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Mousson', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, University Hospital of Dijon, Dijon, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Pernin', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, University Hospital of Montpellier, Montpellier, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Pouteil-Noble', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, E. Herriot Hospital, Université Lyon I, Lyon, France.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Purgus', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, University Hospital of Marseille, Marseille, France.'}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Sayegh', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, University Hospital of Angers, Angers, France.'}, {'ForeName': 'Pierre-François', 'Initials': 'PF', 'LastName': 'Westeel', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, University Hospital of Amiens, Amiens, France.'}, {'ForeName': 'Bénédicte', 'Initials': 'B', 'LastName': 'Sautenet', 'Affiliation': 'Department of Nephrology, Hypertension, Dialysis and Kidney Transplantation, University hospital of Tours, Tours, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gatault', 'Affiliation': 'Department of Nephrology, Hypertension, Dialysis and Kidney Transplantation, University hospital of Tours, Tours, France.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Büchler', 'Affiliation': 'Department of Nephrology, Hypertension, Dialysis and Kidney Transplantation, University hospital of Tours, Tours, France.'}]",Transplant international : official journal of the European Society for Organ Transplantation,['10.1111/tri.13613'] 144,32282787,"The Use of a Novel, Nonsurgical Bone Conduction Hearing Aid System for the Treatment of Conductive Hearing Loss.","OBJECTIVE Conventional bone conduction hearing aid solutions often require a cumbersome retention system such as a headband or cap. This study aims to determine if a novel, nonsurgical bone conduction aid utilizing an adhesive attachment over the mastoid is equivalent to the conventional bone conduction hearing aid (BCHA) for the management of conductive hearing loss. STUDY DESIGN Prospective, single-subject randomized, crossover trial. SETTING Tertiary referral center. PATIENTS Eleven adults and 1 child between 11 and 70 years of age with unilateral conductive hearing loss were enrolled. INTERVENTION Patients had their baseline hearing assessed and were randomized to receive either the novel device or BCHA headband system. Hearing loss etiologies were varied and included cholesteatoma, otosclerosis, chronic otitis media, and previous head and neck surgery. Patients had their baseline hearing assessed and trialled both the novel device or the BCHA headband system. Patients were randomly assigned one device which was worn for 2 weeks followed by a 2-week trial with the alternate device. MAIN OUTCOME MEASURE Pure-tone thresholds and speech discrimination in quiet and noise were tested and patients also completed the short form of the Speech Spatial and Quality of Hearing (SSQ) questionnaire. RESULTS The mean unaided 4 frequency pure-tone average (PTA) air conduction threshold was 53.9 dB, bone conduction was 11.9 dB, and the mean air bone gap was 42 dB in the target ear. One patient with an adhesive skin reaction could not complete the protocol. Aided PTA and threshold testing between 250 Hz to 8000 Hz showed statistically equivalent results between both devices. The aided CNC word score, signal-to-noise ratio, and SSQ scores were also equivalent between both devices. CONCLUSION The novel bone conduction aid demonstrates equivalent performance to the conventional BCHA headband solution. The novel device should be considered an alternative option where the cosmetic and comfort issues of a headband worn device are a concern.",2020,"The aided CNC word score, signal-to-noise ratio, and SSQ scores were also equivalent between both devices. ","['Tertiary referral center', 'Conductive Hearing Loss', 'Eleven adults and 1 child between 11 and 70 years of age with unilateral conductive hearing loss were enrolled', 'Patients had their baseline hearing assessed and trialled both the novel device or the BCHA headband system']","['conventional bone conduction hearing aid (BCHA', 'novel device or BCHA headband system']","['Speech Spatial and Quality of Hearing (SSQ) questionnaire', 'aided CNC word score, signal-to-noise ratio, and SSQ scores', 'mean unaided 4 frequency pure-tone average (PTA) air conduction threshold', 'mean air bone gap', 'Hearing loss etiologies']","[{'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0018777', 'cui_str': 'Conductive hearing loss'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1955772', 'cui_str': 'Unilateral conductive hearing loss'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0005935', 'cui_str': 'Bone conduction'}, {'cui': 'C0018768', 'cui_str': 'Hearing aid'}, {'cui': 'C0453975', 'cui_str': 'Headband'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0005935', 'cui_str': 'Bone conduction'}, {'cui': 'C0018768', 'cui_str': 'Hearing aid'}, {'cui': 'C0493535', 'cui_str': 'Bone-conduction hearing aid'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0453975', 'cui_str': 'Headband'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0406810', 'cui_str': 'Carney complex'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439846', 'cui_str': 'Unaided'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0234744', 'cui_str': 'Air conduction'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0015127', 'cui_str': 'etiology'}]",11.0,0.0471179,"The aided CNC word score, signal-to-noise ratio, and SSQ scores were also equivalent between both devices. ","[{'ForeName': 'Jafri', 'Initials': 'J', 'LastName': 'Kuthubutheen', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Broadbent', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Marino', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery.'}, {'ForeName': 'Dayse', 'Initials': 'D', 'LastName': 'Távora-Vieira', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery.'}]","Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology",['10.1097/MAO.0000000000002657'] 145,31353275,Using Interactive Nutrition Modules to Increase Critical Thinking Skills in College Courses.,"OBJECTIVE To understand how the addition of an evidence-based framework to an online nutrition module influences college students' critical thinking decision making (CT-DM). DESIGN Students were individually randomized into an intervention group or a control group. The nutrition modules focused on 2 topics related to different types of eating behavior. Students completed a CT-DM activity to generate a score. PARTICIPANTS College students, between 18 and 24 years old, recruited from introductory nutrition and agriculture science courses at 2 universities. INTERVENTION Intervention and control received 2 nutrition modules. The intervention added a CT-DM framework that framed the topic as a problem, incorporated activities, and provided scaffolding. MAIN OUTCOME MEASURES CT-DM was scored using a validated rubric to assess the use of critical thinking skills when making a food-related decision. Green eating and critical thinking disposition were measured. ANALYSIS Hierarchical linear regression and t tests were used to assess outcomes. RESULTS A total of 431 students participated (intervention = 203; control = 228). After controlling for university, the intervention group scored significantly higher on CT-DM (18.1 ± 7.6) compared with the control (15.4 ± 8.4); F (3,428) = 14.58, P < .001. CONCLUSIONS AND IMPLICATIONS The results show that an evidence-based framework using nutrition topics encourages CT-DM skills. Future higher-education nutrition interventions should use frameworks to enhance student learning.",2020,"After controlling for university, the intervention group scored significantly higher on CT-DM (18.1 ± 7.6) compared with the control (15.4 ± 8.4); F (3,428) = 14.58, P < .001. ","['Students', 'College students, between 18 and 24 years old, recruited from introductory nutrition and agriculture science courses at 2 universities', '431 students participated (intervention\u202f=\u202f203; control\u202f=\u202f228', 'College Courses']","['Interactive Nutrition Modules', 'Intervention and control received 2 nutrition modules']","['critical thinking skills', 'CT-DM activity', 'Green eating and critical thinking disposition', 'CT-DM']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0001829', 'cui_str': 'Farming'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C4279941', 'cui_str': 'Critical Thinking'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0332583', 'cui_str': 'Green color (qualifier value)'}, {'cui': 'C0743223', 'cui_str': 'Disposition (disposition)'}]",,0.0722239,"After controlling for university, the intervention group scored significantly higher on CT-DM (18.1 ± 7.6) compared with the control (15.4 ± 8.4); F (3,428) = 14.58, P < .001. ","[{'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'McNamara', 'Affiliation': 'School of Food and Agriculture, University of Maine, Orono, ME. Electronic address: jade.mcnamara@maine.edu.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Sweetman', 'Affiliation': 'School of Education, University of Rhode Island, Kingston, RI.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Connors', 'Affiliation': 'College of Merchandizing, Hospitality and Tourism, University of Northern Texas, Denton, TX.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Lofgren', 'Affiliation': 'Department of Nutrition and Food Science, University of Rhode Island, Kingston, RI.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Greene', 'Affiliation': 'Department of Nutrition and Food Science, University of Rhode Island, Kingston, RI.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2019.06.007'] 146,32282525,Evaluation of Postpartum Pelvic Floor Physical Therapy on Obstetrical Anal Sphincter Injury: A Randomized Controlled Trial.,"OBJECTIVE The aim of the study was to evaluate a short course of postpartum pelvic floor physical therapy (PFPT) on symptoms and quality of life after obstetrical anal sphincter injuries (OASIS). METHODS This was a multicenter, randomized controlled trial. Adult women were eligible if they had a vaginal delivery complicated by OASIS and did not have a prior vaginal delivery after 24 weeks' gestation. Participants were randomized to standard care plus PFPT or standard care alone. The primary outcome was change in the Pelvic Floor Distress Inventory (PFDI-20) at 12 weeks postpartum. Secondary outcomes included other validated questionnaires assessing pelvic floor symptoms and bother. RESULTS We approached 89 eligible women; 50 were enrolled and randomized. We excluded 6 participants in the PFPT group and 1 in the standard care group who withdrew before study initiation or did not provide baseline data at 2 weeks postpartum. Thus, we analyzed 19 in the PFPT group and 24 in the standard care group. The groups were similar with regard to most baseline characteristics.The PFPT group reported significant improvement in pelvic floor symptoms and bother compared with the standard care group, reflected by a decrease of 29.2 (interquartile range = -58.3 to -4.2) compared with 0.0 (interquartile range = -14.6 to 20.8) on the PFDI-20 from 2 to 12 weeks postpartum (P = 0.002). Significant differences also were observed for all PFDI-20 subscales (all P ≤ 0.02). CONCLUSIONS At 12 weeks postpartum, the PFPT group reported a significant improvement in pelvic floor symptoms and bother compared with the standard care group.",2020,"The PFPT group reported significant improvement in pelvic floor symptoms and bother compared with the standard care group, reflected by a decrease of 29.2 (interquartile range = -58.3 to -4.2) compared with 0.0 (interquartile range = -14.6 to 20.8) on the PFDI-20 from 2 to 12 weeks postpartum (P = 0.002).","[""Adult women were eligible if they had a vaginal delivery complicated by OASIS and did not have a prior vaginal delivery after 24 weeks' gestation"", 'after obstetrical anal sphincter injuries (OASIS', 'Obstetrical Anal Sphincter Injury', '89 eligible women; 50 were enrolled and randomized', '6 participants in the PFPT group and 1 in the standard care group who withdrew before study initiation or did not provide baseline data at 2 weeks postpartum']","['postpartum pelvic floor physical therapy (PFPT', 'PFPT', 'standard care plus PFPT or standard care alone', 'Postpartum Pelvic Floor Physical Therapy']","['symptoms and quality of life', 'pelvic floor symptoms and bother', 'validated questionnaires assessing pelvic floor symptoms and bother', 'Pelvic Floor Distress Inventory (PFDI-20', 'PFDI-20 subscales']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C1142258', 'cui_str': 'Anal sphincter injury'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]","[{'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",89.0,0.18306,"The PFPT group reported significant improvement in pelvic floor symptoms and bother compared with the standard care group, reflected by a decrease of 29.2 (interquartile range = -58.3 to -4.2) compared with 0.0 (interquartile range = -14.6 to 20.8) on the PFDI-20 from 2 to 12 weeks postpartum (P = 0.002).","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Von Bargen', 'Affiliation': 'From the Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Boston.'}, {'ForeName': 'Miriam J', 'Initials': 'MJ', 'LastName': 'Haviland', 'Affiliation': 'From the Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Boston.'}, {'ForeName': 'Olivia H', 'Initials': 'OH', 'LastName': 'Chang', 'Affiliation': 'From the Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Boston.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'McKinney', 'Affiliation': ""Center for Pelvic and Women's Health, Marathon Physical Therapy and Sports Medicine, LLC, Norton, MA.""}, {'ForeName': 'Michele R', 'Initials': 'MR', 'LastName': 'Hacker', 'Affiliation': 'From the Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Boston.'}, {'ForeName': 'Eman', 'Initials': 'E', 'LastName': 'Elkadry', 'Affiliation': 'Department of Obstetrics and Gynecology, Mount Auburn Hospital, Cambridge.'}]",Female pelvic medicine & reconstructive surgery,['10.1097/SPV.0000000000000849'] 147,32239322,Efficacy and safety of pirfenidone in systemic sclerosis-related interstitial lung disease-a randomised controlled trial.,"To assess the efficacy and safety of pirfenidone in systemic sclerosis-related interstitial lung disease (SSc-ILD). This was a double-blind, randomised, placebo-controlled, pilot study. Subjects with SSc-ILD and forced vital capacity (FVC) between 50 and 80% of the predicted (%pred) value were randomised in 1:1 ratio to receive either pirfenidone (2400 mg/day) or placebo for 6 months. Primary outcome was the proportion of subjects with either stabilisation or improvement in FVC at 6 months. Secondary outcomes were the absolute change in the %pred FVC, Mahler's dyspnoea index, 6-min walk distance (6MWD), modified Rodnan skin score (MRSS) and serum levels of tumour necrosis factor α (TNF-α) and transforming growth factor β (TGF-β). Thirty-four subjects with median (range) age of 41 (20-63) years (91.2% women) and median (range) %pred FVC of 65 (51-78) were enrolled. Stabilisation/improvement in FVC was seen in 16 (94.1%) and 13 (76.5%) subjects in the pirfenidone and placebo groups, respectively (p = 0.33). The median (range) absolute change in %pred FVC was - 0.55 (- 9 to 7%) and 1.0 (- 42 to 11.5%) in the treatment and control groups, respectively (p = 0.51). The changes in 6MWD, dyspnoea scores, MRSS, and levels of TNF-α and TGF-β were not significantly different between groups. Common adverse events were gastrointestinal disturbances and skin rash. We failed to find a significant beneficial effect of pirfenidone over placebo in improving/stabilising FVC, exercise capacity, symptoms, or skin disease. Study is underpowered to provide conclusive evidence. Larger studies with longer follow-up periods are required.",2020,"We failed to find a significant beneficial effect of pirfenidone over placebo in improving/stabilising FVC, exercise capacity, symptoms, or skin disease.","['Thirty-four subjects with median (range) age of 41 (20-63) years (91.2% women) and median (range) %pred FVC of 65 (51-78) were enrolled', 'systemic sclerosis-related interstitial lung disease', 'systemic sclerosis-related interstitial lung disease (SSc-ILD', 'Subjects with SSc-ILD and forced vital capacity (FVC) between 50 and 80% of the predicted (%pred) value']","['pirfenidone', 'pirfenidone over placebo', 'placebo']","['stabilising FVC, exercise capacity, symptoms, or skin disease', 'proportion of subjects with either stabilisation or improvement in FVC', 'median (range) absolute change in %pred FVC', '6MWD, dyspnoea scores, MRSS, and levels of TNF-α and TGF-β', 'efficacy and safety', 'gastrointestinal disturbances and skin rash', ""absolute change in the %pred FVC, Mahler's dyspnoea index, 6-min walk distance (6MWD), modified Rodnan skin score (MRSS) and serum levels of tumour necrosis factor α (TNF-α) and transforming growth factor β (TGF-β"", 'Efficacy and safety', 'FVC']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]","[{'cui': 'C0298067', 'cui_str': 'pirfenidone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037274', 'cui_str': 'Disorder of skin'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1845861', 'cui_str': 'X-linked intellectual disability Cabezas type'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0232459', 'cui_str': 'Abnormal digestive tract function'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C4728203', 'cui_str': 'Modified Rodnan skin score'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}]",34.0,0.234132,"We failed to find a significant beneficial effect of pirfenidone over placebo in improving/stabilising FVC, exercise capacity, symptoms, or skin disease.","[{'ForeName': 'Nupoor', 'Initials': 'N', 'LastName': 'Acharya', 'Affiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Shefali Khanna', 'Initials': 'SK', 'LastName': 'Sharma', 'Affiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh, India. shefalisania@gmail.com.'}, {'ForeName': 'Debashish', 'Initials': 'D', 'LastName': 'Mishra', 'Affiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Sahajal', 'Initials': 'S', 'LastName': 'Dhooria', 'Affiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Varun', 'Initials': 'V', 'LastName': 'Dhir', 'Affiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}]",Rheumatology international,['10.1007/s00296-020-04565-w'] 148,31838223,Prefrontal but not cerebellar tDCS attenuates renewal of extinguished conditioned eyeblink responses.,"An extended neural network is known to underlie extinction learning. As yet, comparatively little is known about the possible contribution of the cerebellum and the dorsolateral prefrontal cortex (dlPFC). In the present study, transcranial direct current stimulation (tDCS) was used to provide further evidence that the dlPFC and the cerebellum are involved in extinction-related processes. A total of 100 young and healthy human participants were randomly assigned to one of five stimulation groups: (1) anodal tDCS of the cerebellum, (2) cathodal tDCS of the cerebellum, (3) anodal tDCS of the dlPFC, (4) cathodal tDCS of the dlPFC, and (5) sham stimulation. Participants underwent delay eyeblink conditioning using an A-B-A/B renewal paradigm. Two different colors of background light (orange and blue) were used as contexts. On day 1, acquisition of conditioned eyeblink responses was performed in context A, followed by extinction in context B. tDCS was applied during extinction. On day 2, extinction recall was tested in contexts A and B with higher incidence of conditioned responses in acquisition context A compared to extinction context B indicating renewal effects. All groups showed significant effects of acquisition of conditioned eyeblink responses and significant effects of extinction. There was no significant difference in extinction between stimulation groups. During extinction recall, renewal effects were present in all groups, except the group which had received anodal tDCS of the dlPFC during extinction. In the present study, no direct effects of dlPFC or cerebellar tDCS were demonstrated on extinction. Anodal tDCS of the dlPFC, but not the cerebellum, resulted in delayed effects on context-related processes of extinction, possibly explained by shifting attention away from the context and towards the conditioned stimulus during extinction learning. Anodal tDCS of the dlPFC attenuated context-related recall of learned aversive responses. Effects of tDCS, however, were weak and need to be confirmed in future studies. Lack of cerebellar tDCS effects do not exclude a possible role of the cerebellum in extinction-related processes, and are likely explained by methodological limitations of cerebellar tDCS.",2020,"Anodal tDCS of the dlPFC, but not the cerebellum, resulted in delayed effects on context-related processes of extinction, possibly explained by shifting attention away from the context and towards the conditioned stimulus during extinction learning.",['100 young and healthy human participants'],"['anodal tDCS of the cerebellum, 2) cathodal tDCS of the cerebellum, 3) anodal tDCS of the dlPFC, 4) cathodal tDCS of the dlPFC, and 5) sham stimulation', 'tDCS', 'delay eyeblink conditioning using an A-B-A/B renewal paradigm', 'anodal tDCS', 'background light (orange and blue', 'transcranial direct current stimulation (tDCS']","['extinction', 'acquisition of conditioned eyeblink responses']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0007765', 'cui_str': 'Parencephalon'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0440277', 'cui_str': 'Oranges'}, {'cui': 'C1260957', 'cui_str': 'Blue color (qualifier value)'}]","[{'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",100.0,0.0277111,"Anodal tDCS of the dlPFC, but not the cerebellum, resulted in delayed effects on context-related processes of extinction, possibly explained by shifting attention away from the context and towards the conditioned stimulus during extinction learning.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lipp', 'Affiliation': 'Department of Neurology, Essen University Hospital, University of Duisburg-Essen, Hufelandstrasse 55, 45147 Essen, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Draganova', 'Affiliation': 'Department of Neurology, Essen University Hospital, University of Duisburg-Essen, Hufelandstrasse 55, 45147 Essen, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Batsikadze', 'Affiliation': 'Department of Neurology, Essen University Hospital, University of Duisburg-Essen, Hufelandstrasse 55, 45147 Essen, Germany.'}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Ernst', 'Affiliation': 'Department of Neurology, Essen University Hospital, University of Duisburg-Essen, Hufelandstrasse 55, 45147 Essen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Uengoer', 'Affiliation': 'Department of Psychology, Philipps-University Marburg, Gutenbergstraße 18, 35032 Marburg, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Timmann', 'Affiliation': 'Department of Neurology, Essen University Hospital, University of Duisburg-Essen, Hufelandstrasse 55, 45147 Essen, Germany. Electronic address: dagmar.timmann-braun@uni-due.de.'}]",Neurobiology of learning and memory,['10.1016/j.nlm.2019.107137'] 149,31797721,"Growth Hormone Alters Brain Morphometry, Connectivity, and Behavior in Subjects with Fatigue after Mild Traumatic Brain Injury.","Pituitary dysfunction with reduced growth hormone (GH) secretion is common in patients following traumatic brain injury (TBI), and these patients often develop chronic symptoms including fatigue and altered cognition. We examined 18 subjects with a history of mild TBI, fatigue, and insufficient GH secretion. Subjects received GH replacement in a year-long, double-blind, placebo-controlled, crossover study, and were assessed for changes in physical performance, body composition, resting energy expenditure, fatigue, sleep, mood, and neuropsychological status. Additionally, magnetic resonance imaging (MRI) was used to assess changes in brain structure and resting state functional connectivity. GH replacement resulted in decreased fatigue, sleep disturbance, and anxiety, as well as increased resting energy expenditure, improved body composition, and altered perception of submaximal effort when performing exercise testing. Associated brain changes included increased frontal cortical thickness and gray matter volume and resting state connectivity changes in regions associated with somatosensory networks. GH replacement altered brain morphology and connectivity and reduced fatigue and related symptoms in mild TBI patients. Additional studies are needed to understand the mechanisms causing TBI-related fatigue and symptom relief with GH replacement.",2020,Associated brain changes included increased frontal cortical thickness and gray matter volume and resting state connectivity changes in regions associated with somatosensory networks.,"['mild TBI patients', 'patients following traumatic brain injury (TBI', '18 subjects with a history of mild TBI, fatigue, and insufficient GH secretion', 'Subjects with Fatigue after Mild Traumatic Brain Injury']","['placebo', 'Pituitary dysfunction with reduced growth hormone (GH) secretion', 'GH replacement']","['physical performance, body composition, resting energy expenditure, fatigue, sleep, mood, and neuropsychological testing', 'frontal cortical thickness and gray matter volume and resting state connectivity changes', 'brain structure and resting state functional connectivity', 'brain morphology and connectivity and reduced fatigue and related symptoms', 'fatigue, sleep disturbance, and anxiety, as well as increased resting energy expenditure, improved body composition, and altered perception of sub-maximal effort']","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231180', 'cui_str': 'Insufficient'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C3508472', 'cui_str': 'Mild Traumatic Brain Injury'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C2607857'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychologic Tests'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0018220', 'cui_str': 'Gray Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}]",18.0,0.111479,Associated brain changes included increased frontal cortical thickness and gray matter volume and resting state connectivity changes in regions associated with somatosensory networks.,"[{'ForeName': 'Traver', 'Initials': 'T', 'LastName': 'Wright', 'Affiliation': 'Department of Internal Medicine, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Urban', 'Affiliation': 'Department of Internal Medicine, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Durham', 'Affiliation': 'Department of Internal Medicine, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'E Lichar', 'Initials': 'EL', 'LastName': 'Dillon', 'Affiliation': 'Department of Internal Medicine, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Randolph', 'Affiliation': 'Department of Internal Medicine, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Danesi', 'Affiliation': 'Department of Internal Medicine, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Gilkison', 'Affiliation': 'Department of Internal Medicine, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Christof', 'Initials': 'C', 'LastName': 'Karmonik', 'Affiliation': 'Radiology Department, Houston Methodist Research Institute, Houston, Texas.'}, {'ForeName': 'Dennis J', 'Initials': 'DJ', 'LastName': 'Zgaljardic', 'Affiliation': 'Transitional Learning Center at Galveston, Galveston, Texas.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Masel', 'Affiliation': 'Center for Neuro Skills, Bakersfield, California.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Bishop', 'Affiliation': 'Department of Radiology, Stanford University, Stanford, California.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pyles', 'Affiliation': 'Department of Pediatrics, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Seidler', 'Affiliation': 'Department of Applied Physiology and Kinesiology, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Ashton H', 'Initials': 'AH', 'LastName': 'Hierholzer', 'Affiliation': 'Department of School of Medicine, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Sheffield-Moore', 'Affiliation': 'Department of Internal Medicine, University of Texas Medical Branch, Galveston, Texas.'}]",Journal of neurotrauma,['10.1089/neu.2019.6690'] 150,32277211,Evaluation of the effects of polishing systems on surface roughness and morphology of dental composite resin.,"Objectives The aim of this in vitro study was to evaluate the effects of five different two-step diamond impregnated polishing systems (Sof-Lex Spiral, Venus Supra, Komet Spiral, CompoMaster and Shapeguard) on the surface roughness and morphology of a submicron hybrid composite resin material (Brilliant Everglow).Materials and methods Two-hundred composite resin discs were prepared with 180 SiC paper to produce a uniform baseline surface. The samples were randomly assigned to one of five groups and polishing was completed by one operator. The arithmetic mean surface roughness (Ra) was measured using contact profilometry and the surfaces were examined under an SEM.Results Statistical differences (p <0.05) were identified between the surface roughness remaining after use of the polishers. Diatech Shapeguard (0.22 μm, SD 0.08) and Komet Spiral (0.26 μm, SD 0.09) polishers yielded the lowest Ra values, while the CompoMaster polishing system led to the highest surface roughness values (0.55 μm, SD 0.19).Conclusions Within the limits of this in vitro study of the efficacy of diamond impregnated two-step polishing systems, Diatech Shapeguard and Komet Spiral polishing systems produced the lowest surface roughness values. These polishing systems yielded acceptable surface roughness values with regards to oral health and patient comfort.Clinical relevance Similarly designed polishing systems do not produce comparable surface roughness levels and clinicians should be aware of this when considering polishing protocols for composite restorations.",2020,These polishing systems yielded acceptable surface roughness values with regards to oral health and patient comfort.,[],"['step diamond impregnated polishing systems (Sof-Lex Spiral, Venus Supra, Komet Spiral, CompoMaster and Shapeguard', 'polishing systems']","['surface roughness and morphology of dental composite resin', 'arithmetic mean surface roughness (Ra']",[],"[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0057717', 'cui_str': 'Diamond'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0080188', 'cui_str': 'Lymphocyte antigen CD15'}, {'cui': 'C0522554', 'cui_str': 'Spiral shape'}, {'cui': 'C0242748', 'cui_str': 'Venus'}, {'cui': 'C1282910', 'cui_str': 'Upper'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0891703', 'cui_str': 'Composite Dental Resin'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",200.0,0.0283862,These polishing systems yielded acceptable surface roughness values with regards to oral health and patient comfort.,"[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Wheeler', 'Affiliation': ""Faculty of Dentistry, Oral & Craniofacial Sciences, King's College London, London, UK.""}, {'ForeName': 'Sanjukta', 'Initials': 'S', 'LastName': 'Deb', 'Affiliation': ""Faculty of Dentistry, Oral & Craniofacial Sciences, King's College London, London, UK.""}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Millar', 'Affiliation': ""Faculty of Dentistry, Oral & Craniofacial Sciences, King's College London, London, UK. brian.millar@kcl.ac.uk.""}]",British dental journal,['10.1038/s41415-020-1370-8'] 151,32122951,A digital media attention diversion improves mood and fear in patients receiving chemotherapy for recurrent gynecologic malignancies: results of a randomized trial.,"BACKGROUND Recurrent gynecologic cancer patients experience symptoms that affect psychologic, emotional, social, and physical well-being. Chemotherapy can further exacerbate these symptoms. Poor mood, pain, and fatigue are linked and are detrimental to quality of life. Interventions targeting these symptoms may improve patient-reported outcomes and performance status. OBJECTIVES To determine the ability of a humorous digital media attention diversion to improve symptom domains of positive and negative mood during chemotherapy for patients with recurrent gynecologic cancers. STUDY DESIGN This randomized, crossover clinical trial enrolled women with recurrent gynecologic cancers. Subjects participated over three cycles of chemotherapy. The primary outcome was the change in mood on the validated Positive and Negative Affect Scale-Extended (PANAS-X) instrument, which measures positive and negative affect domains. All subjects completed the PANAS-X after receiving chemotherapy during cycle 1 on study. In atudy arm 1, subjects watched their choice of humorous movies on a digital media device while receiving chemotherapy during cycle 2 on study. They selected from non-humorous movies during cycle 3 on study. In arm 2, the order of movies was reversed. After each cycle, mood, fatigue, and other patient-reported outcomes were assessed for comparison with baseline measurements. RESULTS The target enrollment of 66 subjects was achieved. Subjects watched humorous content for an average of 96.0 min and non-humorous content for an average of 62.5 min. Negative mood improved after exposure to humorous (p=0.017) and non-humorous content (p=0.001). Patient-reported fear also improved after exposure to both humorous (p=0.038) and non-humorous content (p=0.002). Subjects reported higher use of affiliating and self-effacing humor types. CONCLUSIONS Offering patients a choice of digital media during chemotherapy significantly improved negative mood and fear. This was seen with both humorous and non-humorous content. This low-cost and low-risk intervention should be implemented as an attention diversion to improve negative mood and fear for patients receiving chemotherapy.",2020,Negative mood improved after exposure to humorous (p=0.017) and non-humorous content (p=0.001).,"['Recurrent gynecologic cancer patients experience symptoms', 'patients receiving chemotherapy', 'patients with recurrent gynecologic cancers', 'enrolled women with recurrent gynecologic cancers', 'patients receiving chemotherapy for recurrent gynecologic malignancies']","['chemotherapy', 'digital media attention diversion', 'humorous digital media attention diversion', 'Chemotherapy', 'digital media device while receiving chemotherapy']","['change in mood on the validated Positive and Negative Affect Scale-Extended (PANAS-X) instrument, which measures positive and negative affect domains', 'Negative mood', 'mood and fear', 'negative mood and fear', 'Poor mood, pain, and fatigue']","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0185033', 'cui_str': 'Diversion'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.0441354,Negative mood improved after exposure to humorous (p=0.017) and non-humorous content (p=0.001).,"[{'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Spencer', 'Affiliation': 'Gynecologic Oncology, University of Wisconsin Madison School of Medicine and Public Health, Madison, Wisconsin, USA rjspencer2@wisc.edu.'}, {'ForeName': 'Vinita', 'Initials': 'V', 'LastName': 'Alexander', 'Affiliation': 'Obstetrics and Gynecology, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Eickhoff', 'Affiliation': 'Biostatistics and Medical Informatics, University of Wisconsin Madison, Madison, Wisconsin, USA.'}, {'ForeName': 'Kaitlin', 'Initials': 'K', 'LastName': 'Woo', 'Affiliation': 'Biostatistics and Medical Informatics, University of Wisconsin Madison, Madison, Wisconsin, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Costanzo', 'Affiliation': 'Psychiatry, University of Wisconsin Madison School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Marx', 'Affiliation': 'Communications Studies, Colorado State University, Fort Collins, Colorado, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Rose', 'Affiliation': 'Gynecologic Oncology, University of Wisconsin Madison School of Medicine and Public Health, Madison, Wisconsin, USA.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2019-001185'] 152,30316010,Third-Line Nivolumab Monotherapy in Recurrent SCLC: CheckMate 032.,"INTRODUCTION For patients with recurrent SCLC, topotecan remains the only approved second-line treatment, and the outcomes are poor. CheckMate 032 is a phase 1/2, multicenter, open-label study of nivolumab or nivolumab plus ipilimumab in SCLC or other advanced/metastatic solid tumors previously treated with one or more platinum-based chemotherapies. We report results of third- or later-line nivolumab monotherapy treatment in SCLC. METHODS In this analysis, patients with limited-stage or extensive-stage SCLC and disease progression after two or more chemotherapy regimens received nivolumab monotherapy, 3 mg/kg every 2 weeks, until disease progression or unacceptable toxicity. The primary end point was objective response rate. Secondary end points included duration of response, progression-free survival, overall survival, and safety. RESULTS Between December 4, 2013, and November 30, 2016, 109 patients began receiving third- or later-line nivolumab monotherapy. At a median follow-up of 28.3 months (from first dose to database lock), the objective response rate was 11.9% (95% confidence interval: 6.5-19.5) with a median duration of response of 17.9 months (range 3.0-42.1). At 6 months, 17.2% of patients were progression-free. The 12-month and 18-month overall survival rates were 28.3% and 20.0%, respectively. Grade 3 to 4 treatment-related adverse events occurred in 11.9% of patients. Three patients (2.8%) discontinued because of treatment-related adverse events. CONCLUSIONS Nivolumab monotherapy provided durable responses and was well tolerated as a third- or later-line treatment for recurrent SCLC. These results suggest that nivolumab monotherapy is an effective third- or later-line treatment for this patient population.",2019,"The 12-month and 18-month overall survival rates were 28.3% and 20.0%, respectively.","['Between December 4, 2013, and November 30, 2016, 109 patients began receiving third- or later-line nivolumab monotherapy', 'patients with limited-stage or extensive-stage SCLC and disease progression after two or more chemotherapy regimens received', 'SCLC or other advanced/metastatic solid tumors previously treated with one or more platinum-based chemotherapies']","['nivolumab or nivolumab plus ipilimumab', 'nivolumab monotherapy', 'third- or later-line nivolumab monotherapy']","['objective response rate', 'duration of response, progression-free survival, overall survival, and safety', 'adverse events', 'overall survival rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0278726', 'cui_str': 'Small cell lung cancer extensive stage'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0149925', 'cui_str': 'Small cell carcinoma of lung'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.0557661,"The 12-month and 18-month overall survival rates were 28.3% and 20.0%, respectively.","[{'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Ready', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina. Electronic address: neal.ready@duke.edu.'}, {'ForeName': 'Anna F', 'Initials': 'AF', 'LastName': 'Farago', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'de Braud', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori Milano and University of Milan, Milan, Italy.'}, {'ForeName': 'Akin', 'Initials': 'A', 'LastName': 'Atmaca', 'Affiliation': 'Krankenhaus Nordwest-Institut für Klinisch-Onkologische Forschung, UCT-University Cancer Center, Frankfurt am Main, Germany.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Hellmann', 'Affiliation': 'Memorial Sloan Kettering Cancer Center Hospital, New York, New York.'}, {'ForeName': 'Jeffrey G', 'Initials': 'JG', 'LastName': 'Schneider', 'Affiliation': 'New York Uuniversity Winthrop University Hospital, Mineola, New York.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Spigel', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology, Nashville, Tennessee.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Moreno', 'Affiliation': 'START Madrid-FJD. Hospital Fundación Jiménez Díaz, Madrid, Spain.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Chau', 'Affiliation': 'Royal Marsden National Health Service Foundation Trust, Surrey, United Kingdom.'}, {'ForeName': 'Christine L', 'Initials': 'CL', 'LastName': 'Hann', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Joseph Paul', 'Initials': 'JP', 'LastName': 'Eder', 'Affiliation': 'Yale Cancer Center, New Haven, Connecticut.'}, {'ForeName': 'Nicola L', 'Initials': 'NL', 'LastName': 'Steele', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Pieters', 'Affiliation': 'Bristol-Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Fairchild', 'Affiliation': 'Bristol-Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Antonia', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2018.10.003'] 153,32266327,"Health care providers' perspectives on delivering gender equity focused family planning program for young married couples in a cluster randomized controlled trial in rural Maharashtra, India.","Background:  There is increasing programming and research on male engagement and gender-equity (GE) counselling in family planning (FP) services. However, there is a lack of data on healthcare provider's perspectives on delivering these interventions. The objective of the paper is to present providers' perspectives on delivering a GE-focused FP intervention, CHARM, to married couples in rural India. Methods:   In-depth interviews were carried out with 22 male village health care providers who were delivering a GE-focused FP intervention, CHARM, to 428 husbands (247 couples) rural Maharashtra, India. Providers were interviewed on their experiences and perspectives during delivery of CHARM. Major domains were identified during a thematic analysis. Results:  Local male health providers are interested and can be engaged in delivering a GE-focused FP intervention. Providers believed that the CHARM intervention improves couples' communication, contraceptive use and strengthened their own capacity to provide FP services in accordance with national FP programmatic efforts. Providers found the low-tech flipchart including pictures and information helpful in supporting their service provision. Providers reported some challenges including lack of privacy and space for counselling, limited access to contraceptive options beyond pill and condom, numerous myths and misconceptions about contraceptives. Providers also reported persistent social norms related to expectancy of pregnancy early in marriage, and son preference. Conclusions: Providers in rural areas with high fertility and related maternal health complications are interested in and can successfully implement a GE-focused FP intervention. Future efforts using this approach may benefit from greater focus to support broader array of spacing contraceptives particularly among first time parents, none or one child parents. There is a need to better support engagement of wives possibly through female provider led sessions parallel to male programs, i.e. gender synchronized rather than couples' sessions. Trial registration : ClinicalTrials.gov  NCT01593943, May 8, 2012.",2019,"Providers believed that the CHARM intervention improves couples' communication, contraceptive use and strengthened their own capacity to provide FP services in accordance with national FP programmatic efforts.","['young married couples', 'rural areas with high fertility and related maternal health complications', 'married couples in rural India', '22 male village health care providers who were delivering a GE-focused FP intervention, CHARM, to 428 husbands (247 couples) rural Maharashtra, India', 'Local male health providers']","['CHARM intervention', 'GE-focused FP intervention, CHARM']",[],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0024921', 'cui_str': 'Maternal Health'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517775', 'cui_str': '428'}, {'cui': 'C0242664', 'cui_str': 'Husband'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}]",[],22.0,0.0630654,"Providers believed that the CHARM intervention improves couples' communication, contraceptive use and strengthened their own capacity to provide FP services in accordance with national FP programmatic efforts.","[{'ForeName': 'Saritha', 'Initials': 'S', 'LastName': 'Nair', 'Affiliation': 'ICMR-National Institute of Medical Statistics (NIMS), New Delhi, Delhi, 110029, India.'}, {'ForeName': 'Anvita', 'Initials': 'A', 'LastName': 'Dixit', 'Affiliation': 'Center on Gender Equity and Health, School of Medicine, University of California San Diego, 9500 Gilman Drive #0507, La Jolla, CA, 92093-0507, USA.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Ghule', 'Affiliation': 'Center on Gender Equity and Health, School of Medicine, University of California San Diego, 9500 Gilman Drive #0507, La Jolla, CA, 92093-0507, USA.'}, {'ForeName': 'Madhusudana', 'Initials': 'M', 'LastName': 'Battala', 'Affiliation': 'Population Council, New Delhi, Delhi, 110003, India.'}, {'ForeName': 'Velhal', 'Initials': 'V', 'LastName': 'Gajanan', 'Affiliation': 'Seth G S Medical College & KEM Hospital, Mumbai, Maharashtra, 400012, India.'}, {'ForeName': 'Anindita', 'Initials': 'A', 'LastName': 'Dasgupta', 'Affiliation': 'School of Social Work, Columbia University, New York, NY, 10027, USA.'}, {'ForeName': 'Shahina', 'Initials': 'S', 'LastName': 'Begum', 'Affiliation': 'ICMR-National Institute for Research in Reproductive Health, J.M Street, Parel, Mumbai, 400012, India.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Averbach', 'Affiliation': 'Center on Gender Equity and Health, School of Medicine, University of California San Diego, 9500 Gilman Drive #0507, La Jolla, CA, 92093-0507, USA.'}, {'ForeName': 'Balaiah', 'Initials': 'B', 'LastName': 'Donta', 'Affiliation': 'ICMR-National Institute for Research in Reproductive Health, J.M Street, Parel, Mumbai, 400012, India.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Silverman', 'Affiliation': 'Center on Gender Equity and Health, School of Medicine, University of California San Diego, 9500 Gilman Drive #0507, La Jolla, CA, 92093-0507, USA.'}, {'ForeName': 'Niranjan', 'Initials': 'N', 'LastName': 'Saggurti', 'Affiliation': 'Population Council, New Delhi, Delhi, 110003, India.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Raj', 'Affiliation': 'Center on Gender Equity and Health, School of Medicine, University of California San Diego, 9500 Gilman Drive #0507, La Jolla, CA, 92093-0507, USA.'}]",Gates open research,['10.12688/gatesopenres.13026.1'] 154,32274500,A novel approach to management of sleep-associated problems in patients with breast cancer (MOSAIC) during chemotherapy : A pilot study.,"STUDY OBJECTIVES This pilot randomized controlled trial (RCT) was conducted to assess the preliminary effects of Brief Behavioral Therapy for Cancer-Related Insomnia (BBT-CI) delivered by trained research staff in comparison to a sleep hygiene pamphlet control and to assess moderators of treatment effect in patients with breast cancer undergoing chemotherapy. METHODS Of 74 participants recruited, 37 were randomized to BBT-CI and 37 were randomized to the control condition. Trained staff members delivered the intervention during chemotherapy treatments to reduce patients' burden. Insomnia was assessed with the Insomnia Severity Index (ISI), anxiety was assessed with the Spielberger State-Trait Anxiety Inventory, symptom burden was assessed with the Symptom Inventory (SI), and study staff recorded previous treatments and surgeries received by patients. RESULTS Patients randomized to BBT-CI showed significantly greater improvements in their ISI scores compared to the sleep hygiene group. Additionally, several treatment moderators were identified. The effect of BBT-CI was greater among individuals with lower baseline state-trait anxiety, with previous surgery for cancer, and with higher baseline somatic symptom severity. CONCLUSIONS BBT-CI shows preliminary efficacy compared to the sleep hygiene handout on insomnia in cancer patients undergoing chemotherapy. A large-phase III RCT needs to be conducted to replicate the preliminary findings.",2020,"RESULTS Patients randomized to BBT-CI showed significantly greater improvements in their ISI scores than the sleep hygiene group.","['Breast Cancer Patients (MOSAIC', 'cancer patients undergoing chemotherapy', 'Of 74 participants recruited, 37 were randomized to', 'breast cancer patients undergoing chemotherapy', 'Cancer-Related Insomnia (BBT-CI']","['BBT-CI', 'Brief Behavioral Therapy']","['BBT-CI', 'Insomnia', 'Spielberger State-Trait Anxiety Inventory (STAI), symptom burden', 'Insomnia Severity Index (ISI), anxiety', 'ISI scores']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439750', 'cui_str': 'Mosaic'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0451497', 'cui_str': 'Spielberger state-trait anxiety inventory'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4706228', 'cui_str': 'ISI (Insomnia Severity Index) score'}]",74.0,0.0578566,"RESULTS Patients randomized to BBT-CI showed significantly greater improvements in their ISI scores than the sleep hygiene group.","[{'ForeName': 'Oxana', 'Initials': 'O', 'LastName': 'Palesh', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Solomon', 'Affiliation': 'PGSP Stanford Psy.D. Consortium, Palo Alto University, Palo Alto, CA.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Hofmeister', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'Booil', 'Initials': 'B', 'LastName': 'Jo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'Hanyang', 'Initials': 'H', 'LastName': 'Shen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Cassidy-Eagle', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'Pasquale F', 'Initials': 'PF', 'LastName': 'Innominato', 'Affiliation': 'North Wales Cancer Centre, Ysbyty Gwynedd, Betsi Cadwaladr University Health Board, Bangor, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Mustian', 'Affiliation': 'Department of Surgery, University of Rochester, Rochester, NY.'}, {'ForeName': 'Shelli', 'Initials': 'S', 'LastName': 'Kesler', 'Affiliation': 'Cancer Neuroscience Laboratory, School of Nursing, University of Texas at Austin, Austin, TX.'}]",Sleep,['10.1093/sleep/zsaa070'] 155,32257848,"Double-blind randomized controlled study of the efficacy, safety and tolerability of eszopiclone vs placebo for the treatment of patients with post-traumatic stress disorder and insomnia.","BACKGROUND Sleep disturbance is a core feature of post-traumatic stress disorder (PTSD). Given the relationship between sleep disturbance and PTSD, there has been a relative paucity of studies examining the potential therapeutic impact of using pharmacotherapy to target sleep disturbance in patients with PTSD. Eszopiclone (ESZ) is a non-benzodiazepine y-aminobutyric acid-A receptor agonist indicated for the treatment of sleep and may affect sleep in patients with PTSD. AIM To evaluate the efficacy of ESZ vs placebo (PBO) for patients with PTSD and insomnia. METHODS The study was a 12-wk, double blind, randomized controlled trial with 3 mg of ESZ ( n = 13) or PBO ( n = 12). RESULTS Patients in both arms experienced significant improvement in PTSD symptoms as assessed by the Clinician-Administered PTSD Scale for DSM-IV (CAPS): ESZ (t11 = -3.12, P = 0.005) and PBO (t11 = -3.5, P = 0.002) and by self-report with the Short PTSD Rating Interview (ESZ t11 = -3.38, P = 0.003 and PBO t11 = -4.48, P = 0.0005). There were no significant differences between treatments on the CAPS (t22 = -0.13, P = 0.70) or the Short PTSD Rating Interview (t22 = -0.58, P = 0.56). Similarly, both treated groups improved on sleep measures as assessed by the Pittsburgh Sleep Quality Index with PTSD Addendum (PSQI) and on total sleep time (TST) and sleep latency assessed by actigraphy with no significant differences between groups (PSQI t22 = -0.24, P = 0.81; total sleep time t10 = 0.13, P = 0.90 and sleep latency t10 = 0.68, P = 0.50). There was a significant correlation between improvement in sleep and overall improvement in PTSD as measured by change scores on the PSQI and CAPS, r(8) = 0.79, P = 0.01 for ESZ treated subjects, but not for those treated with PBO r(9) = 0.16, P = 0.69. Adverse events of ESZ were consistent with the known profile of the medication including dysgeusia (30%, mild), sedation (20%, mild) and headache (20%, moderate to severe). CONCLUSION Results do not support the hypothesis of a specific positive effect of ESZ compared to PBO for measures of PTSD and associated sleep disturbance.",2020,"There was a significant correlation between improvement in sleep and overall improvement in PTSD as measured by change scores on the PSQI and CAPS, r(8) = 0.79, P = 0.01 for ESZ treated subjects, but not for those treated with PBO r(9) = 0.16, P = 0.69.","['patients with PTSD', 'patients with PTSD and insomnia', ' n = 13) or PBO ( n = 12', 'patients with post-traumatic stress disorder and insomnia']","['ESZ vs placebo (PBO', 'eszopiclone vs placebo', 'ESZ', 'Eszopiclone (ESZ']","['sleep measures', 'CAPS', 'Clinician-Administered PTSD Scale for DSM-IV (CAPS): ESZ', 'efficacy, safety and tolerability', 'PTSD symptoms', 'sleep and overall improvement in PTSD', 'headache', 'Pittsburgh Sleep Quality Index with PTSD Addendum (PSQI) and on total sleep time (TST) and sleep latency assessed by actigraphy', 'Short PTSD Rating Interview', 'sleep disturbance', 'PBO', 'dysgeusia', 'total sleep time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}, {'cui': 'C1436328', 'cui_str': 'Eszopiclone'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}, {'cui': 'C0013378', 'cui_str': 'Taste sense altered'}]",,0.0222934,"There was a significant correlation between improvement in sleep and overall improvement in PTSD as measured by change scores on the PSQI and CAPS, r(8) = 0.79, P = 0.01 for ESZ treated subjects, but not for those treated with PBO r(9) = 0.16, P = 0.69.","[{'ForeName': 'Sheila M', 'Initials': 'SM', 'LastName': 'Dowd', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, IL 60601, United States. sheila_dowd@rush.edu.'}, {'ForeName': 'Alyson K', 'Initials': 'AK', 'LastName': 'Zalta', 'Affiliation': 'Department of Psychological Science, University of California Irvine, Irvine, CA 92697, United States.'}, {'ForeName': 'Helen J', 'Initials': 'HJ', 'LastName': 'Burgess', 'Affiliation': 'Sleep and Circadian Research Laboratory, Department of Psychiatry, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Adkins', 'Affiliation': 'Center for Behavioral Intervention Technologies | Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL 60611, United States.'}, {'ForeName': 'Zerbrina', 'Initials': 'Z', 'LastName': 'Valdespino-Hayden', 'Affiliation': 'Department of Psychology, Montclair State University, Montclair, NJ 07043, United States.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Pollack', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, IL 60601, United States.'}]",World journal of psychiatry,['10.5498/wjp.v10.i3.21'] 156,32035124,Protocol paper: Stepped wedge cluster randomized trial translating the ABCS into optimizing cardiovascular care for people living with HIV.,"People living with HIV (PWH) are at higher risk for cardiovascular disease (CVD) and stroke in comparison to their non-infected counterparts. The ABCS (aspirin-blood pressure control-cholesterol control-smoking cessation) reduce atherosclerotic (ASCVD) risk in the general population, but little is known regarding strategies for promoting the ABCS among PWH. Guided by the Consolidated Framework for Implementation Research (CFIR), we designed multilevel implementation strategies that target PWH and their clinicians to promote appropriate use of the ABCS based on a 10-year estimated ASCVD risk. Implementation strategies include patient coaching, automated texting, peer phone support, academic detailing and audit and feedback for the patient's clinician. We are evaluating implementation through a stepped wedge cluster randomized trial based on the Reach-Effectiveness-Adoption-Maintenance/Qualitative-Evaluation-for-Systematic-Translation (RE-AIM/QuEST) mixed methods framework that integrates quantitative and qualitative assessments. The primary outcome is change in ASCVD risk. Findings will have important implications regarding strategies for reducing ASCVD risk among PWH.",2020,People living with HIV (PWH) are at higher risk for cardiovascular disease (CVD) and stroke in comparison to their non-infected counterparts.,"['people living with HIV', 'People living with HIV (PWH']","['ABCS (aspirin-blood pressure control-cholesterol control-smoking cessation', 'ABCS']",['change in ASCVD risk'],"[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.0702008,People living with HIV (PWH) are at higher risk for cardiovascular disease (CVD) and stroke in comparison to their non-infected counterparts.,"[{'ForeName': 'Stephen K', 'Initials': 'SK', 'LastName': 'Williams', 'Affiliation': 'Department of Population Health, Center for Healthful Behavior Change, New York University School of Medicine, New York, NY.'}, {'ForeName': 'Brent A', 'Initials': 'BA', 'LastName': 'Johnson', 'Affiliation': 'Department of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, NY.'}, {'ForeName': 'Jonathan N', 'Initials': 'JN', 'LastName': 'Tobin', 'Affiliation': 'Clinical Directors Network (CDN), Community-Engaged Research, The Rockefeller University Center for Clinical and Translational Science, New York, NY.'}, {'ForeName': 'Amneris Esther', 'Initials': 'AE', 'LastName': 'Luque', 'Affiliation': 'Infectious Diseases and Geographic Medicine, HIV Program at Parkland Health and Hospital System, Community Prevention and Intervention Unit, UT Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Mechelle', 'Initials': 'M', 'LastName': 'Sanders', 'Affiliation': 'Department of Family Medicine, University of Rochester Medical Center, Rochester, NY.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Carroll', 'Affiliation': 'Department of Family Medicine, University of Colorado, Aurora, CO.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cassells', 'Affiliation': 'Clinical Directors Network, Inc. (CDN), New York, NY.'}, {'ForeName': 'Tameir', 'Initials': 'T', 'LastName': 'Holder', 'Affiliation': 'Clinical Directors Network, Inc. (CDN), New York, NY.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Fiscella', 'Affiliation': 'Department of Family Medicine, University of Rochester Medical Center, Rochester, NY. Electronic address: Kevin_fiscella@urmc.rochester.edu.'}]",Progress in cardiovascular diseases,['10.1016/j.pcad.2020.02.003'] 157,32266572,Near Infrared (NIR) Fluorescence is Not a Substitute for Lymphoscintigraphy and Gamma Probe for Melanoma Sentinel Node Detection: Results from a Prospective Trial.,"BACKGROUND Sentinel lymph node (SLN) biopsy is the standard care for early detection and staging of lymph node metastasis in melanomas. Radiocolloids (RC) and blue dyes are used for SLN detection. Recently, near infrared (NIR) fluorescence tracing using indocyanine green has been developed as an alternative method for SLN detection. The relatively high tissue penetration depth of several millimeters and the ability to detect low concentrations of tracer both suggest that NIR may have significant advantages over RC and the blue dye methods. The objective of this study was to prospectively compare the performance of all three SLN detection techniques using them sequentially to evaluate the same group of patients. METHODS One hundred twenty-one primary cutaneous melanoma patients with an indication for SLN biopsy were assigned to the procedure following NIR, blue dye, and RC detection techniques. RESULTS No adverse event was reported. SLN was not detected in only 4.1% of cases. In 90.9%, an SLN was identified with NIR, but without any auxiliary technique in only 70.2% of cases. RC detected the SLN in 92.6% of cases. Patent blue was found in the sentinel node in 76.9%. The combination of all three techniques detected an SLN in 95.9% of cases. Metastases were present in 26.7%. The false-negative rate was 8.8%, with a negative predictive value of 91.2%. CONCLUSIONS RC was the only technique with high SLN detection. Both the blue dye and NIR methods added sensitivity to the detection rate but should not be a substitute for RC.",2020,No adverse event was reported.,"['One hundred twenty-one primary cutaneous melanoma patients with an indication for SLN biopsy', 'Melanoma Sentinel Node Detection']","['procedure following NIR, blue dye, and RC detection techniques']","['SLN', 'false-negative rate']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0677944', 'cui_str': 'Sentinel node'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0013343', 'cui_str': 'Dye'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]","[{'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C0205558', 'cui_str': 'False negative'}]",121.0,0.0539327,No adverse event was reported.,"[{'ForeName': 'Carlos Eduardo Barbosa', 'Initials': 'CEB', 'LastName': 'de Carvalho', 'Affiliation': 'Department of Surgery, Melanoma and Sarcoma, Barretos Cancer Hospital, Barretos, SP, Brazil.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Capuzzo', 'Affiliation': 'Department of Head and Neck, Barretos Cancer Hospital, Barretos, SP, Brazil.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Crovador', 'Affiliation': 'Institute of Education and Research, Barretos Cancer Hospital, Barretos, SP, Brazil.'}, {'ForeName': 'Renan J', 'Initials': 'RJ', 'LastName': 'Teixeira', 'Affiliation': 'Institute of Education and Research, Barretos Cancer Hospital, Barretos, SP, Brazil.'}, {'ForeName': 'Ana Carolina', 'Initials': 'AC', 'LastName': 'Laus', 'Affiliation': 'Institute of Education and Research, Barretos Cancer Hospital, Barretos, SP, Brazil.'}, {'ForeName': 'Andre Lopes', 'Initials': 'AL', 'LastName': 'Carvalho', 'Affiliation': 'Institute of Education and Research, Barretos Cancer Hospital, Barretos, SP, Brazil.'}, {'ForeName': 'Vinicius L', 'Initials': 'VL', 'LastName': 'Vazquez', 'Affiliation': 'Department of Surgery, Melanoma and Sarcoma, Barretos Cancer Hospital, Barretos, SP, Brazil. viniciusvazquez@gmail.com.'}]",Annals of surgical oncology,['10.1245/s10434-020-08409-6'] 158,32270185,Association Between Improved Mobility and Distal Health Outcomes.,"BACKGROUND We examined the association between improved mobility and distal health outcomes in older adults using secondary analysis of data from a cluster-randomized controlled group exercise trial. METHODS Participants were 303 men and women aged ≥65 and older in 32 independent living facilities, senior apartments, and community centers who participated in 12-week group exercise interventions. Included were those who completed ≥1 follow-up phone call regarding outcomes assessment in the following year. Gait speed and 6-minute walk distance (6MWD) were assessed at baseline and immediately after 12-week interventions to determine mobility performance change status. Falls, emergency department (ED) visits, and hospitalizations were assessed monthly for 12 months following the end of interventions via interactive voice response phone calls. Incident rate ratios (IRRs) were calculated to quantify incidence of adverse outcomes with respect to mobility performance change. RESULTS Each 0.05 m/s increase in gait speed resulted in an 11% reduction in falls (IRR = 0.89; 95% confidence interval [CI], 0.84-0.94; p < .0001); a similar decrease was seen for each 20 m increase in 6MWD (IRR = 0.89; 95% CI, 0.83-0.93; p = .0003). Those who improved gait speed had 61 falls per 1,000 person-months versus 135 in those who had no change/a decline. Those who improved 6MWD had 67 falls per 1,000 person-months versus 110 per 1,000 person-months in those who had no change/a decline. Differences in ED visits and hospitalizations were not statistically significant. CONCLUSION Improvements in mobility performance are associated with lower incidence of future falls. Given the exploratory nature of the findings, further investigation is warranted.",2020,Those who improved gait speed had 61 falls per 1000 person-months versus 135 in those who had no change/a decline.,"['Participants were 303 men and women aged ≥65 years in 32 independent living facilities, senior apartments, and community centers who participated in 12-week group', 'older adults']",['exercise interventions'],"['6MWD', 'Incident rate ratios (IRRs', 'Gait speed and six-minute walk distance (6MWD', 'mobility performance', 'mobility and distal health outcomes', 'Falls, emergency department (ED) visits, and hospitalizations', 'gait speed', 'ED visits and hospitalizations']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0457933', 'cui_str': 'Apartment'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",303.0,0.0736643,Those who improved gait speed had 61 falls per 1000 person-months versus 135 in those who had no change/a decline.,"[{'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Shuman', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Coyle', 'Affiliation': 'Department of Physical Therapy, University of Delaware, Newark.'}, {'ForeName': 'Subashan', 'Initials': 'S', 'LastName': 'Perera', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'Jessie M', 'Initials': 'JM', 'LastName': 'Van Swearingen', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'Steve M', 'Initials': 'SM', 'LastName': 'Albert', 'Affiliation': 'Department of Behavioral and Community Health Sciences, University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Brach', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Pennsylvania.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glaa086'] 159,32271354,Efficacy and Safety of Pembrolizumab Plus Docetaxel vs Docetaxel Alone in Patients With Previously Treated Advanced Non-Small Cell Lung Cancer: The PROLUNG Phase 2 Randomized Clinical Trial.,"Importance Because of socioeconomic factors, many patients with advanced non-small cell lung cancer (NSCLC) do not receive immunotherapy in the first-line setting. It is unknown if the combination of immunotherapy with chemotherapy can provide clinical benefits in immunotherapy-naive patients with disease progression after treatment with platinum-based chemotherapy. Objective To evaluate the safety and efficacy of the combination of pembrolizumab plus docetaxel in patients with previously treated advanced NSCLC following platinum-based chemotherapy regardless of EGFR variants or programmed cell death ligand 1 status. Design, Setting, and Participants The Pembrolizumab Plus Docetaxel for Advanced Non-Small Cell Lung Cancer (PROLUNG) trial randomized 78 patients with histologically confirmed advanced NSCLC in a 1:1 ratio to receive either pembrolizumab plus docetaxel or docetaxel alone from December 2016 through May 2019. Interventions The experimental arm received docetaxel on day 1 (75 mg/m2) plus pembrolizumab on day 8 (200 mg) every 3 weeks for up to 6 cycles followed by pembrolizumab maintenance until progression or unacceptable toxic effects. The control arm received docetaxel monotherapy. Main Outcomes and Measures The primary end point was overall response rate (ORR). Secondary end points included progression-free survival (PFS), overall survival, and safety. Results Among 78 recruited patients, 32 (41%) were men, 34 (44%) were never smokers, and 25 (32%) had an EGFR/ALK alteration. Forty patients were allocated to receive pembrolizumab plus docetaxel, and 38 were allocated to receive docetaxel. A statistically significant difference in ORR, assessed by an independent reviewer, was found in patients receiving pembrolizumab plus docetaxel vs patients receiving docetaxel (42.5% vs 15.8%; odds ratio, 3.94; 95% CI, 1.34-11.54; P = .01). Patients without EGFR variations had a considerable difference in ORR of 35.7% vs 12.0% (P = .06), whereas patients with EGFR variations had an ORR of 58.3% vs 23.1% (P = .14). Overall, PFS was longer in patients who received pembrolizumab plus docetaxel (9.5 months; 95% CI, 4.2-not reached) than in patients who received docetaxel (3.9 months; 95% CI, 3.2-5.7) (hazard ratio, 0.24; 95% CI, 0.13-0.46; P < .001). For patients without variations, PFS was 9.5 months (95% CI, 3.9-not reached) vs 4.1 months (95% CI, 3.5-5.3) (P < .001), whereas in patients with EGFR variations, PFS was 6.8 months (95% CI, 6.2-not reached) vs 3.5 months (95% CI, 2.3-6.2) (P = .04). In terms of safety, 23% (9 of 40) vs 5% (2 of 38) of patients experienced grade 1 to 2 pneumonitis in the pembrolizumab plus docetaxel and docetaxel arms, respectively (P = .03), while 28% (11 of 40) vs 3% (1 of 38) experienced any-grade hypothyroidism (P = .002). No new safety signals were identified. Conclusions and Relevance In this phase 2 study, the combination of pembrolizumab plus docetaxel was well tolerated and substantially improved ORR and PFS in patients with advanced NSCLC who had previous progression after platinum-based chemotherapy, including NSCLC with EGFR variations. Trial Registration ClinicalTrials.gov Identifier: NCT02574598.",2020,"For patients without variations, PFS was 9.5 months (95% CI, 3.9-not reached) vs 4.1 months (95% CI, 3.5-5.3) (","['patients with previously treated advanced NSCLC following platinum-based chemotherapy regardless of EGFR variants or programmed cell death ligand 1 status', 'Forty patients', 'patients with advanced NSCLC who had previous progression after platinum-based chemotherapy, including NSCLC with EGFR variations', 'for Advanced Non-Small Cell Lung Cancer (PROLUNG) trial randomized 78 patients with histologically confirmed advanced NSCLC in a 1:1 ratio to receive either', 'immunotherapy-naive patients with disease progression after treatment with platinum-based chemotherapy', '78 recruited patients, 32 (41%) were men, 34 (44%) were never smokers, and 25 (32%) had an EGFR/ALK alteration', 'Patients', 'patients with advanced non-small cell lung cancer (NSCLC', 'With Previously Treated Advanced Non-Small Cell Lung Cancer', 'alone from December 2016 through May 2019']","['immunotherapy with chemotherapy', 'Pembrolizumab Plus Docetaxel', 'docetaxel monotherapy', 'Pembrolizumab Plus Docetaxel vs Docetaxel Alone', 'pembrolizumab', 'pembrolizumab plus docetaxel or docetaxel', 'pembrolizumab plus docetaxel', 'pembrolizumab plus docetaxel and docetaxel', 'docetaxel']","['ORR', 'overall response rate (ORR', 'grade hypothyroidism', 'safety and efficacy', 'ORR and PFS', 'Overall, PFS', 'progression-free survival (PFS), overall survival, and safety', 'Efficacy and Safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0425293', 'cui_str': 'Never smoked tobacco'}, {'cui': 'C1663627', 'cui_str': 'ALK protein, human'}]","[{'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",78.0,0.210182,"For patients without variations, PFS was 9.5 months (95% CI, 3.9-not reached) vs 4.1 months (95% CI, 3.5-5.3) (","[{'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Arrieta', 'Affiliation': 'Thoracic Oncology Unit, Laboratory of Experimental Oncology, National Cancer Institute (INCan), Mexico City, Mexico.'}, {'ForeName': 'Feliciano', 'Initials': 'F', 'LastName': 'Barrón', 'Affiliation': 'Thoracic Oncology Unit, Laboratory of Experimental Oncology, National Cancer Institute (INCan), Mexico City, Mexico.'}, {'ForeName': 'Laura Alejandra', 'Initials': 'LA', 'LastName': 'Ramírez-Tirado', 'Affiliation': 'Thoracic Oncology Unit, Laboratory of Experimental Oncology, National Cancer Institute (INCan), Mexico City, Mexico.'}, {'ForeName': 'Zyanya Lucia', 'Initials': 'ZL', 'LastName': 'Zatarain-Barrón', 'Affiliation': 'Thoracic Oncology Unit, Laboratory of Experimental Oncology, National Cancer Institute (INCan), Mexico City, Mexico.'}, {'ForeName': 'Andrés F', 'Initials': 'AF', 'LastName': 'Cardona', 'Affiliation': 'Clinical and Translational Oncology Group, Clínica del Country, Bogotá, Colombia.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Díaz-García', 'Affiliation': 'Thoracic Oncology Unit, Laboratory of Experimental Oncology, National Cancer Institute (INCan), Mexico City, Mexico.'}, {'ForeName': 'Masao', 'Initials': 'M', 'LastName': 'Yamamoto Ramos', 'Affiliation': 'Thoracic Oncology Unit, Laboratory of Experimental Oncology, National Cancer Institute (INCan), Mexico City, Mexico.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Mota-Vega', 'Affiliation': 'Thoracic Oncology Unit, Laboratory of Experimental Oncology, National Cancer Institute (INCan), Mexico City, Mexico.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Carmona', 'Affiliation': 'Thoracic Oncology Unit, Laboratory of Experimental Oncology, National Cancer Institute (INCan), Mexico City, Mexico.'}, {'ForeName': 'Marco Polo', 'Initials': 'MP', 'LastName': 'Peralta Álvarez', 'Affiliation': 'Thoracic Oncology Unit, Laboratory of Experimental Oncology, National Cancer Institute (INCan), Mexico City, Mexico.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Bautista', 'Affiliation': 'Hospital de Oncología, Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, Mexico City, Mexico.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Aldaco', 'Affiliation': 'Servicio de Oncología Médica, Centro Médico Nacional 20 de Noviembre, Mexico City, Mexico.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Gerson', 'Affiliation': 'Departamento de Oncología, Centro Médico ABC, Mexico City, Mexico.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rolfo', 'Affiliation': 'Thoracic Medical Oncology and Early Clinical Trials, Marlene and Stewart Greenebaum Comprehensive Cancer Center, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Rosell', 'Affiliation': 'Molecular and Cellular Oncology Laboratory, Germans Trias i Pujol Research Institute and Hospital (IGTP), Barcelona, Spain.'}]",JAMA oncology,['10.1001/jamaoncol.2020.0409'] 160,32270440,Imeglimin Does Not Induce Clinically Relevant Pharmacokinetic Interactions When Combined with Either Metformin or Sitagliptin in Healthy Subjects.,"BACKGROUND AND OBJECTIVES Imeglimin (IMEG) is the first in a novel class of oral glucose-lowering agents with a unique mechanism of action targeting mitochondrial bioenergetics. We assessed whether repeated co-administration of IMEG and either metformin (MET) or sitagliptin (SITA) would influence the pharmacokinetics of either MET or SITA in healthy Caucasian men. METHODS Healthy Caucasian men received either MET 850 mg twice daily with placebo (n = 16) or SITA 100 mg once daily with placebo (n = 16) on days 1-6, followed by MET 850 mg twice daily with IMEG 1500 mg twice daily or SITA 100 mg once daily with IMEG 1500 mg twice daily on days 7-12. Pharmacokinetic parameters were determined from blood and urine; levels of all compounds were evaluated using liquid chromatography with tandem mass spectrometry. RESULTS Systemic exposure (AUC 0-τ area under the plasma concentration-time curve over a dosing interval and maximum concentration) to MET was 14% and 10% lower, respectively, when administered with IMEG. Approximately 40% of MET was excreted unchanged in urine, decreasing to 34% when given with IMEG. The 90% confidence intervals for AUC 0-τ and maximum concentration indicated no effect of co-administration on systemic exposure to MET. Mean AUC 0-τ and maximum concentration of SITA were similar with or without IMEG. Median times to maximum concentration were 0.7 and 1.0 h and mean elimination half-lives were 8.2 and 8.7 h with and without IMEG, respectively. Systemic exposure to IMEG was similar to previous phase I studies. CONCLUSIONS Co-administration of IMEG with MET or SITA did not result in clinically relevant changes in systemic exposure to MET or SITA, although minor reductions in exposure (AUC 0-τ and maximum concentration) and renal elimination were noted when MET was given with IMEG vs placebo. CLINICAL TRIAL REGISTRATION EudraCT2009-014520-40 (MET-IMEG DDI) and EudraCT2010-022926-34 (SITA-IMEG DDI).",2020,The 90% confidence intervals for AUC 0-τ and maximum concentration indicated no effect of co-administration on systemic exposure to MET.,"['healthy Caucasian men', 'Healthy Caucasian men', 'Healthy Subjects']","['IMEG and either metformin (MET) or sitagliptin (SITA', 'MET 850\xa0mg twice daily with IMEG 1500\xa0mg twice daily or SITA 100', 'MET 850\xa0mg twice daily with placebo', 'SITA 100\xa0mg once daily with placebo', 'Metformin', 'IMEG', 'Imeglimin (IMEG', 'IMEG 1500']","['Systemic exposure (AUC 0-τ area under the plasma concentration-time curve', 'Mean AUC 0-τ and maximum concentration of SITA', 'Median times to maximum concentration', 'exposure (AUC 0-τ and maximum concentration) and renal elimination']","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C3840657', 'cui_str': '850'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C3501765', 'cui_str': 'imeglimin'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1373187', 'cui_str': 'Renal Excretion'}]",,0.218336,The 90% confidence intervals for AUC 0-τ and maximum concentration indicated no effect of co-administration on systemic exposure to MET.,"[{'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Fouqueray', 'Affiliation': 'Poxel SA, 259/261 Avenue Jean Jaurès, 69007, Lyon, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Perrimond-Dauchy', 'Affiliation': 'Poxel SA, 259/261 Avenue Jean Jaurès, 69007, Lyon, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Bolze', 'Affiliation': 'Poxel SA, 259/261 Avenue Jean Jaurès, 69007, Lyon, France. sebastien.bolze@poxelpharma.com.'}]",Clinical pharmacokinetics,['10.1007/s40262-020-00886-y'] 161,31702385,Effect of a nurse-led individualized self-management program for Chinese patients with acute myocardial infarction undergoing percutaneous coronary intervention.,"BACKGROUND The study of the development and evaluation of self-management intervention among patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI) is lacking, especially in China. AIM To examine the effects of a nurse-led individualized self-management program (NISMP) on health behaviors, control of cardiac risk factors, and health-related quality of life (HRQoL) among patients with AMI undergoing PCI. METHODS The quasi-experimental design included a convenience sample of 112 participants recruited from a tertiary hospital in China. The participants were assigned to the control group ( n = 56) or the intervention group ( n = 56). The intervention group underwent the NISMP, which includes six group-based education sessions, a face-to-face individual consultation, and 12-month telephone follow-ups. Data were collected at baseline and at the end of the 12-month program using the Health Promotion Lifestyle Profile, the Risk Factors Assessment Form, and the Short Form 36-item Health Survey. RESULTS The baseline sociodemographic and clinical characteristics of the two groups were comparable ( p > 0.05). After the 12-month intervention, the health behaviors and HRQoL of the participants in the intervention group had significantly improved ( p < 0.05 for both) compared to those of the control group. Compared to the control group, the participants in the intervention group also reported significantly better control of cardiac risk factors including smoking (χ 2 = 4.709, p = 0.030), low-density lipoprotein (χ 2 = 4.160, p = 0.041), body mass index (χ 2 = 3.886, p = 0.049) and exercise (χ 2 = 10.096, p = 0.001). CONCLUSION The NISMP demonstrated positive effects on health behaviors, control of cardiac risk factors, and HRQoL among Chinese patients with AMI undergoing PCI.",2020,"Compared to the control group, the participants in the intervention group also reported significantly better control of cardiac risk factors including smoking (χ 2 = 4.709, p = 0.030), low-density lipoprotein (χ 2 = 4.160, p = 0.041), body mass index (χ 2 = 3.886, p = 0.049) and exercise (χ 2 = 10.096, p = 0.001). ","['patients with acute myocardial infarction (AMI) undergoing', 'Chinese patients with acute myocardial infarction undergoing percutaneous coronary intervention', 'patients with AMI undergoing PCI', '112 participants recruited from a tertiary hospital in China', 'Chinese patients with AMI undergoing PCI']","['nurse-led individualized self-management program (NISMP', 'nurse-led individualized self-management program', 'percutaneous coronary intervention (PCI', 'NISMP', 'self-management intervention', 'NISMP, which includes six group-based education sessions, a face-to-face individual consultation, and 12-month telephone follow-ups']","['health behaviors, control of cardiac risk factors, and health-related quality of life (HRQoL', 'health behaviors, control of cardiac risk factors, and HRQoL', 'low-density lipoprotein', 'body mass index', 'health behaviors and HRQoL', 'control of cardiac risk factors including smoking']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}]","[{'cui': 'C0018687'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]",112.0,0.0308392,"Compared to the control group, the participants in the intervention group also reported significantly better control of cardiac risk factors including smoking (χ 2 = 4.709, p = 0.030), low-density lipoprotein (χ 2 = 4.160, p = 0.041), body mass index (χ 2 = 3.886, p = 0.049) and exercise (χ 2 = 10.096, p = 0.001). ","[{'ForeName': 'Wenhui', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': ""Xi'an Jiaotong University Health Science Center, China.""}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Feng', 'Affiliation': ""Xi'an Jiaotong University Health Science Center, China.""}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': ""Cardiology Department, First Affiliated Hospital of Xi'an Jiaotong University, China.""}, {'ForeName': 'Juanli', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Cardiology Department, First Affiliated Hospital of Xi'an Jiaotong University, China.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Gao', 'Affiliation': ""Xi'an Jiaotong University Health Science Center, China.""}, {'ForeName': 'Wenru', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}]",European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology,['10.1177/1474515119889197'] 162,32266415,Hamstring grafts for anterior cruciate ligament reconstruction show better magnetic resonance features when tibial insertion is preserved.,"PURPOSE Comparing the MRI features of the grafts between a group of patients treated with an over-the-top anterior cruciate ligament reconstruction technique that preserves the hamstring attachment and a control group with a classical reconstruction technique. METHODS Patients were assigned to a standard reconstruction technique or an Over-the-top plus lateral plasty technique. All patients underwent preoperative, 4-months and 18-months MRI; together with a clinical evaluation with KOOS and KT1000 laxity assessment. MRI study involved different parameters: the ""Graft"" was evaluated with the continuity, Howell Grading system, presence of liquid and signal noise quotient. The ""Tibial Tunnel"" was evaluated with the signal noise quotient, presence of edema or liquid and tunnel widening. All points assigned to each parameter formed a composite score ranging from 0-10. Tunnel and graft positioning were evaluated. RESULTS At 18-month 20 MRIs (10 each group) were available, demographics were not significantly different between groups. The non-detached group showed significantly less liquid within the graft at 4-months (p = 0.008) and 18-months (p = 0.028), the tunnel was significantly smaller (p < 0.05) and less enlarged at both follow-ups (p < 0.05), signal noise quotient of the intra-tunnel graft was lower at 18-months (p < 0.05). The total score of the non-detached group saw a significant improvement at 4-months (p = 0.006) that remained stable at 18-months (n.s.). CONCLUSIONS Hamstring grafts, which tibial insertions were preserved, showed better MRI features at 4-and 18-months follow-up, especially in terms of liquid effusion, tunnel enlargement and signal noise quotient. LEVEL OF EVIDENCE IV.",2021,"The non-detached group showed significantly less liquid within the graft at 4-months (p = 0.008) and 18-months (p = 0.028), the tunnel was significantly smaller (p < 0.05) and less enlarged at both follow-ups (p < 0.05),",['Patients'],"['Hamstring grafts for anterior cruciate ligament reconstruction', 'standard reconstruction technique or an Over-the-top plus lateral plasty technique']","['signal noise quotient of the intra-tunnel graft', 'MRI features', 'total score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}]","[{'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0173407,"The non-detached group showed significantly less liquid within the graft at 4-months (p = 0.008) and 18-months (p = 0.028), the tunnel was significantly smaller (p < 0.05) and less enlarged at both follow-ups (p < 0.05),","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Grassi', 'Affiliation': 'Clinica Ortopedica e Traumatologica II, IRCCS Istituto Ortopedico Rizzoli, Via C. Pupilli 1, 40136, Bologna, BO, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Casali', 'Affiliation': 'Clinica Ortopedica e Traumatologica II, IRCCS Istituto Ortopedico Rizzoli, Via C. Pupilli 1, 40136, Bologna, BO, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Macchiarola', 'Affiliation': 'Clinica Ortopedica e Traumatologica II, IRCCS Istituto Ortopedico Rizzoli, Via C. Pupilli 1, 40136, Bologna, BO, Italy. luca.macchiarola@hotmail.it.'}, {'ForeName': 'Gian Andrea', 'Initials': 'GA', 'LastName': 'Lucidi', 'Affiliation': 'Clinica Ortopedica e Traumatologica II, IRCCS Istituto Ortopedico Rizzoli, Via C. Pupilli 1, 40136, Bologna, BO, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Cucurnia', 'Affiliation': 'Clinica Ortopedica e Traumatologica II, IRCCS Istituto Ortopedico Rizzoli, Via C. Pupilli 1, 40136, Bologna, BO, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Filardo', 'Affiliation': 'Centro di Ricerca Applicata e Traslazionale, IRCCS Istituto Ortopedico Rizzoli, Via di Barbiano 1/10, 40136, Bologna, BO, Italy.'}, {'ForeName': 'Nicola Francesco', 'Initials': 'NF', 'LastName': 'Lopomo', 'Affiliation': ""Dipartimento di Ingegneria Dell' Informazione, Univertità di Brescia, Brescia, BS, Italia.""}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Zaffagnini', 'Affiliation': 'Clinica Ortopedica e Traumatologica II, IRCCS Istituto Ortopedico Rizzoli, Via C. Pupilli 1, 40136, Bologna, BO, Italy.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-020-05948-z'] 163,32083990,Standard Anthracycline Based Versus Docetaxel-Capecitabine in Early High Clinical and/or Genomic Risk Breast Cancer in the EORTC 10041/BIG 3-04 MINDACT Phase III Trial.,"PURPOSE MINDACT demonstrated that 46% of patients with early breast cancer at high clinical but low genomic risk on the basis of MammaPrint may safely avoid adjuvant chemotherapy. A second random assignment (R-C) compared docetaxel-capecitabine with an anthracycline-based regimen. PATIENTS AND METHODS R-C randomly assigned patients 1:1 between standard anthracycline-based regimens, with or without taxanes (control) and experimental docetaxel 75 mg/m 2 intravenously plus oral capecitabine 825 mg/m 2 two times per day for 14 days (DC) every 3 weeks for 6 cycles. The primary end point was disease-free survival (DFS). Secondary end points included overall survival and safety. RESULTS Of 2,832 patients, 1,301 (45%) were randomly assigned, and 97% complied with R-C assignment. In the control arm, 29.6% only received taxanes (0.5% of N0 patients). DFS events (n = 148) were much less than required (n = 422) as a result of a lower-than-expected accrual and event rate. At 5 years of median follow-up, DFS was not different between DC (n = 652) and control (n = 649; 90.7% [95% CI, 88% to 92.8%] v 88.8% [95% CI, 85.9% to 91.1%]; hazard ratio [HR], 0.83 [95% CI, 0.60 to 1.15]; P = .26). Overall survival (HR, 0.91 [95% CI, 0.54 to 1.53]) and DFS in the clinical high and genomic high-risk subgroup (86.1% v 88.1%; HR, 0.83 [95% CI, 0.58 to 1.21]) were similar in both arms. DC led to more grade 1 neuropathy (27.1% v 11.2%) and more grade 2 hand/foot syndrome (28.5% v 3.3%) and diarrhea (13.7% v 5.8%). Serious cardiac events occurred in 9 patients (control, n = 4; DC, n = 5). Fifty-three patients developed second cancers (control, n = 32; DC, n = 21; leukemia: 2 v 1). Five treatment-related deaths occurred (control, 2 [0.3%]; DC, 3 [0.5%]). CONCLUSION Although underpowered, this second randomization in MINDACT did not show any improvement in outcome or safety with the use of DC compared with anthracycline-based chemotherapy.",2020,"Overall survival (HR, 0.91","['R-C randomly assigned patients 1:1 between', 'Early High Clinical and/or Genomic Risk Breast Cancer in the EORTC', 'Fifty-three patients developed second cancers (control, n = 32; DC, n = 21; leukemia: 2 v 1', 'Of 2,832 patients, 1,301 (45', 'patients with early breast cancer at high clinical but low genomic risk']","['standard anthracycline-based regimens, with or without taxanes (control) and experimental docetaxel 75 mg/m 2 intravenously plus oral capecitabine', 'docetaxel-capecitabine with an anthracycline-based regimen', 'taxanes', 'anthracycline-based chemotherapy', 'Standard Anthracycline Based Versus Docetaxel-Capecitabine']","['grade 2 hand/foot syndrome', 'diarrhea', 'DFS events', 'overall survival and safety', 'grade 1 neuropathy', 'Overall survival', 'disease-free survival (DFS', 'deaths', 'Serious cardiac events']","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0887950', 'cui_str': 'Genomics'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0751623', 'cui_str': 'Second Cancer'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",148.0,0.127737,"Overall survival (HR, 0.91","[{'ForeName': 'Suzette', 'Initials': 'S', 'LastName': 'Delaloge', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Piccart', 'Affiliation': 'Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Emiel', 'Initials': 'E', 'LastName': 'Rutgers', 'Affiliation': 'Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Litière', 'Affiliation': 'European Organization for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': ""van 't Veer"", 'Affiliation': 'Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Franchette', 'Initials': 'F', 'LastName': 'van den Berkmortel', 'Affiliation': 'Zuyderland Medisch Centrum, Heerlen-Geleen, the Netherlands.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Brain', 'Affiliation': 'Institut Curie-Hôpital Rene Huguenin, Saint-Cloud, France.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Dudek-Peric', 'Affiliation': 'European Organization for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Gil-Gil', 'Affiliation': ""Institut Catala D'Oncologia-Institut d'Investigacio Biomedica de Bellvitge, L'Hospitalet, Barcelona, Spain.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Gomez', 'Affiliation': ""Hospital General Vall D'Hebron, Barcelona, Spain.""}, {'ForeName': 'Florentine S', 'Initials': 'FS', 'LastName': 'Hilbers', 'Affiliation': 'Breast International Group, Brussels, Belgium.'}, {'ForeName': 'Zaman', 'Initials': 'Z', 'LastName': 'Khalil', 'Affiliation': 'Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Knox', 'Affiliation': 'Europa Donna-The European Breast Cancer Coalition, Milan, Italy.'}, {'ForeName': 'Sherko', 'Initials': 'S', 'LastName': 'Kuemmel', 'Affiliation': 'Breast Unit Kliniken Essen-Mitte, Westdeutsche Studiengruppe, Mönchengladbach, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Kunz', 'Affiliation': 'St Johannes Hospital, Dortmund, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Lesur', 'Affiliation': 'Institut de Cancérologie de Lorraine, Vandoeuvre-Les-Nancy, France.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Pierga', 'Affiliation': 'Institut Curie-Hôpital Rene Huguenin, Saint-Cloud, France.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ravdin', 'Affiliation': 'The University of Texas Health Sciences Center, San Antonio, TX.'}, {'ForeName': 'Isabel T', 'Initials': 'IT', 'LastName': 'Rubio', 'Affiliation': 'Clinica Universidad de Navarra-Site Madrid, Madrid, Spain.'}, {'ForeName': 'Mahasti', 'Initials': 'M', 'LastName': 'Saghatchian', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Tineke J', 'Initials': 'TJ', 'LastName': 'Smilde', 'Affiliation': ""Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, the Netherlands.""}, {'ForeName': 'Alastair M', 'Initials': 'AM', 'LastName': 'Thompson', 'Affiliation': 'Baylor University College of Medicine, Houston, TX.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Viale', 'Affiliation': 'University of Milan and European Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Zoppoli', 'Affiliation': 'University of Genoa and Azienda Ospedaliera Universitaria San Martino, Genova, Italy.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vuylsteke', 'Affiliation': 'Centre Hospitalier Universitaire, Université Catholique de Louvain, Namur, Belgium.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Tryfonidis', 'Affiliation': 'European Organization for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Coralie', 'Initials': 'C', 'LastName': 'Poncet', 'Affiliation': 'European Organization for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Bogaerts', 'Affiliation': 'European Organization for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Cardoso', 'Affiliation': 'Champalimaud Clinical Center/Champalimaud Foundation, Lisbon, Portugal.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01371'] 164,32142961,Effectiveness of myAirCoach: A mHealth Self-Management System in Asthma.,"BACKGROUND Self-management programs have beneficial effects on asthma control, but their implementation in clinical practice is poor. Mobile health (mHealth) could play an important role in enhancing self-management. OBJECTIVE To assess the clinical effectiveness and technology acceptance of myAirCoach-supported self-management on top of usual care in patients with asthma using inhalation medication. METHODS Patients were recruited in 2 separate studies. The myAirCoach system consisted of an inhaler adapter, an indoor air-quality monitor, a physical activity tracker, a portable spirometer, a fraction exhaled nitric oxide device, and an app. The primary outcome was asthma control; secondary outcomes were exacerbations, quality of life, and technology acceptance. In study 1, 30 participants were randomized to either usual care or myAirCoach support for 3 to 6 months; in study 2, 12 participants were provided with the myAirCoach system in a 3-month before-after study. RESULTS In study 1, asthma control improved in the intervention group compared with controls (Asthma Control Questionnaire difference, 0.70; P = .006). A total of 6 exacerbations occurred in the intervention group compared with 12 in the control group (hazard ratio, 0.31; P = .06). Asthma-related quality of life improved (mini Asthma-related Quality of Life Questionnaire difference, 0.53; P = .04), but forced expiratory volume in 1 second was unchanged. In study 2, asthma control improved by 0.86 compared with baseline (P = .007) and quality of life by 0.16 (P = .64). Participants reported positive attitudes toward the system. DISCUSSION Using the myAirCoach support system improves asthma control and quality of life, with a reduction in severe asthma exacerbations. Well-validated mHealth technologies should therefore be further studied.",2020,"Asthma related quality of life improved (m-AQLQ difference 0.53, p= 0.04), but FEV1 was unchanged.","['asthma', 'asthma patients using inhalation medication ', '30 participants', 'Patients were recruited in two separate studies']","['myAirCoach supported self-management', 'usual care or myAirCoach support', 'myAirCoach support system', 'myAirCoach']","['Asthma related quality of life', 'six exacerbations', 'quality of life', 'asthma control', 'severe asthma exacerbations', 'FEV1', 'exacerbations, quality of life, and technology acceptance', 'asthma control and quality of life']","[{'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]",30.0,0.0768581,"Asthma related quality of life improved (m-AQLQ difference 0.53, p= 0.04), but FEV1 was unchanged.","[{'ForeName': 'Rishi J', 'Initials': 'RJ', 'LastName': 'Khusial', 'Affiliation': 'Department of Biomedical Data Sciences, Section Medical Decision Making, Leiden University Medical Center, Leiden, the Netherlands. Electronic address: R.J.Khusial@lumc.nl.'}, {'ForeName': 'Persijn J', 'Initials': 'PJ', 'LastName': 'Honkoop', 'Affiliation': 'Department of Biomedical Data Sciences, Section Medical Decision Making, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Usmani', 'Affiliation': 'Airway Disease, National Heart and Lung Institute, Imperial College London, London, United Kingdom; Royal Brompton and Harefield NHS Trust, London, United Kingdom.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Soares', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, NIHR Manchester Biomedical Research Centre (BRC), University of Manchester, Manchester, United Kingdom; Manchester University NHS Foundation Trust - Wythenshawe Hospital, Manchester, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Simpson', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, NIHR Manchester Biomedical Research Centre (BRC), University of Manchester, Manchester, United Kingdom; Manchester University NHS Foundation Trust - Wythenshawe Hospital, Manchester, United Kingdom.'}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Biddiscombe', 'Affiliation': 'Airway Disease, National Heart and Lung Institute, Imperial College London, London, United Kingdom; Royal Brompton and Harefield NHS Trust, London, United Kingdom.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Meah', 'Affiliation': 'Airway Disease, National Heart and Lung Institute, Imperial College London, London, United Kingdom; Royal Brompton and Harefield NHS Trust, London, United Kingdom.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Bonini', 'Affiliation': 'Airway Disease, National Heart and Lung Institute, Imperial College London, London, United Kingdom; Royal Brompton and Harefield NHS Trust, London, United Kingdom.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Lalas', 'Affiliation': 'Information Technologies Institute, Centre for Research and Technology - Hellas (CERTH), Thessaloniki, Greece.'}, {'ForeName': 'Eleftheria', 'Initials': 'E', 'LastName': 'Polychronidou', 'Affiliation': 'Information Technologies Institute, Centre for Research and Technology - Hellas (CERTH), Thessaloniki, Greece.'}, {'ForeName': 'Julia G', 'Initials': 'JG', 'LastName': 'Koopmans', 'Affiliation': 'Department of Pulmonology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Moustakas', 'Affiliation': 'Electrical and Computer Engineering Department, University of Patras, Rion-Patras, Greece.'}, {'ForeName': 'Jiska B', 'Initials': 'JB', 'LastName': 'Snoeck-Stroband', 'Affiliation': 'Department of Biomedical Data Sciences, Section Medical Decision Making, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Ortmann', 'Affiliation': 'IHP - Leibniz-Institut für innovative Mikroelektronik, Frankfurt (Oder), Germany.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Votis', 'Affiliation': 'Information Technologies Institute, Centre for Research and Technology - Hellas (CERTH), Thessaloniki, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Tzovaras', 'Affiliation': 'Information Technologies Institute, Centre for Research and Technology - Hellas (CERTH), Thessaloniki, Greece.'}, {'ForeName': 'Kian Fan', 'Initials': 'KF', 'LastName': 'Chung', 'Affiliation': 'Airway Disease, National Heart and Lung Institute, Imperial College London, London, United Kingdom; Royal Brompton and Harefield NHS Trust, London, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Fowler', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, NIHR Manchester Biomedical Research Centre (BRC), University of Manchester, Manchester, United Kingdom; Manchester University NHS Foundation Trust - Wythenshawe Hospital, Manchester, United Kingdom.'}, {'ForeName': 'Jacob K', 'Initials': 'JK', 'LastName': 'Sont', 'Affiliation': 'Department of Biomedical Data Sciences, Section Medical Decision Making, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.02.018'] 165,32020057,"The role of appetite-related hormones, adaptive thermogenesis, perceived hunger and stress in long-term weight-loss maintenance: a mixed-methods study.","BACKGROUND/OBJECTIVES Weight-loss maintenance is challenging, and few succeed in the long term. This study aimed to explain how appetite-related hormones, adaptive thermogenesis, perceived hunger and stress influence weight-loss maintenance. SUBJECTS/METHODS Fifteen adult women (age, 46.3 ± 9.5 years; BMI, 39.4 ± 4.3 kg/m 2 ) participated in a 24-month intervention, which included 3-5 months total diet replacement (825-853 kcal/d). Body weight and composition (Magnetic Resonance Imaging), resting metabolic rate (indirect calorimetry), and fasting plasma concentration of leptin, ghrelin, glucagon-like peptide-1 (GLP-1), peptide YY (PYY), and growth differentiation factor 15 (GDF-15) were measured at baseline and after weight loss, around 6 months. Perceptions relating to weight-loss maintenance were explored using qualitative interviews. RESULTS Mean (SD) changes in body weight (-13.8 ± 6.3 kg) and total adipose tissue (-11.5 ± 4.9 kg) were significant (P < 0.001). Weight loss was associated with a significant reduction in resting metabolic rate (-291 ± 226 kcal/day, P < 0.001) and adaptive thermogenesis (-150 ± 162 kcal/day, P = 0.003), reduction in leptin (P < 0.001) and GLP-1 (P = 0.015), an increase in ghrelin (P < 0.001), and no changes in PYY and GDF-15. Weight regain between 6 and 24 months (6.1 ± 6.3 kg, P < 0.05) was correlated positively with change in GLP-1 (r = 0.5, P = 0.037) and negatively with GLP-1 at baseline (r = -0.7, P = 0.003) and after weight loss (r = -0.7, P = 0.005). Participants did not report increased hunger after weight loss, and stress-related/emotional eating was perceived as the main reason for regain. CONCLUSIONS Weight regain is more likely with lower fasting GLP-1 and greater reduction in GLP-1 after weight loss, but psychological aspects of eating behaviour appear as important in attenuating weight-loss maintenance.",2020,"Weight regain between 6 and 24 months (6.1 ± 6.3 kg, P < 0.05) was correlated positively with change in GLP-1 (","['Fifteen adult women (age, 46.3\u2009±\u20099.5 years']",[],"['Weight regain', 'resting metabolic rate', 'GLP-1', 'hunger after weight loss, and stress-related/emotional eating', 'Weight loss', 'adaptive thermogenesis', 'Body weight and composition (Magnetic Resonance Imaging), resting metabolic rate (indirect calorimetry), and fasting plasma concentration of leptin, ghrelin, glucagon-like peptide-1', 'Mean (SD) changes in body weight', 'reduction in leptin', 'weight loss', 'change in GLP-1 ', 'total adipose tissue', 'GLP-1), peptide YY (PYY), and growth differentiation factor 15 (GDF-15']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C4235304', 'cui_str': 'Adaptive Thermogenesis'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0006781', 'cui_str': 'Calorimetry, Respiration'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin (substance)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0070358', 'cui_str': 'PYY Peptide'}, {'cui': 'C0668195', 'cui_str': 'Prostate Differentiation Factor'}]",15.0,0.0274015,"Weight regain between 6 and 24 months (6.1 ± 6.3 kg, P < 0.05) was correlated positively with change in GLP-1 (","[{'ForeName': 'George', 'Initials': 'G', 'LastName': 'Thom', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Stephan U', 'Initials': 'SU', 'LastName': 'Dombrowski', 'Affiliation': 'Faculty of Kinesiology, University of New Brunswick, Fredericton, NB, Canada.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Brosnahan', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Yasmin Y', 'Initials': 'YY', 'LastName': 'Algindan', 'Affiliation': 'Department of Clinical Nutrition, College of Applied Medical Sciences, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rosario Lopez-Gonzalez', 'Affiliation': 'Department of Radiology, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Giles', 'Initials': 'G', 'LastName': 'Roditi', 'Affiliation': 'Department of Radiology, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Michael E J', 'Initials': 'MEJ', 'LastName': 'Lean', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'Malkova', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow Royal Infirmary, Glasgow, UK. dalia.malkova@glasgow.ac.uk.'}]",European journal of clinical nutrition,['10.1038/s41430-020-0568-9'] 166,32187417,"An examination of changes in skeletal muscle thickness, echo intensity, strength and soreness following resistance exercise.","It is suggested that changes in echo intensity (EI) measured through ultrasound can detect muscle swelling. However, changes in EI have never been examined relative to a non-exercise control following naïve exposure to exercise. PURPOSE Examine the changes in muscle thickness (MT), EI and isometric strength (ISO) before, immediately after, and 24, and 48 hr following biceps curls. METHODS Twenty-seven non-resistance-trained individuals visited the laboratory four times. During visit 1, paperwork was completed and strength was measured. During visit 2, MT and ISO were measured before four sets of curls. Additional measures were taken immediately after exercise, as well as 24 and 48 hr post. Results are displayed as means (SD). RESULTS For MT, there was an interaction (p < .001). For the experimental condition, MT increased from pre [2.88(0.64) cm] to post [3.27(0.67) cm] and remained elevated 48 hr post. There were no changes for MT in the control arm. In the experimental arm, EI increased from pre [22.9(9.6) AU] to post [29.1(12.3) AU] exercise and returned to baseline by 24 hr. For the control condition, EI was different between pre [24.8(10.2) AU] and 48 hr [21.5(10.7) AU]. The change in EI in the experimental condition was greater than the control condition immediately post (p = .039) and at 48 hr (p = .016). For ISO, there was an interaction (p < .001). In the experimental condition, ISO decreased from pre [40.6(14.7) Nm)] to post [24.8(9.4) Nm] and remained depressed. CONCLUSIONS Exercise produced a swelling response, which was elevated 48 hr post. Despite a sustained increase in MT, EI was only elevated immediately post exercise.",2020,The change in EI in the experimental condition was greater than the control condition immediately post (p = .039) and at 48 hr (p = .016).,['27 non-resistance trained individuals visited the laboratory 4 times'],[],"['swelling response', 'muscle thickness (MT), EI and isometric strength (ISO', 'Skeletal Muscle Thickness, Echo Intensity, Strength, and Soreness Following Resistance Exercise', 'MT, EI']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",[],"[{'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0911936', 'cui_str': 'iso(VL)'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.0690848,The change in EI in the experimental condition was greater than the control condition immediately post (p = .039) and at 48 hr (p = .016).,"[{'ForeName': 'Noam', 'Initials': 'N', 'LastName': 'Yitzchaki', 'Affiliation': 'USF Muscle Lab, Exercise Science Program, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Wenyuan G', 'Initials': 'WG', 'LastName': 'Zhu', 'Affiliation': 'USF Muscle Lab, Exercise Science Program, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Tayla E', 'Initials': 'TE', 'LastName': 'Kuehne', 'Affiliation': 'USF Muscle Lab, Exercise Science Program, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Ecaterina', 'Initials': 'E', 'LastName': 'Vasenina', 'Affiliation': 'USF Muscle Lab, Exercise Science Program, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Dankel', 'Affiliation': 'Exercise Physiology Laboratory, Department of Health and Exercise Science, Rowan University, Glassboro, NJ, USA.'}, {'ForeName': 'Samuel L', 'Initials': 'SL', 'LastName': 'Buckner', 'Affiliation': 'USF Muscle Lab, Exercise Science Program, University of South Florida, Tampa, FL, USA.'}]",Clinical physiology and functional imaging,['10.1111/cpf.12630'] 167,32228238,Reach Out Emergency Department: Partnering With an Economically Disadvantaged Community in the Development of a Text-Messaging Intervention to Address High Blood Pressure.,"Background. Hypertension affects nearly 30% of the U.S. adult population. Due to the ubiquitous nature of mobile phone usage, text messaging offers a promising platform for interventions to assist in the management of chronic diseases including hypertension, including among populations that are historically underserved. We present the intervention development of Reach Out, a health behavior theory-based, mobile health intervention to reduce blood pressure among hypertensive patients evaluated in a safety net emergency department primarily caring for African Americans. Aims. To describe the process of designing and refining text messages currently being implemented in the Reach Out randomized controlled trial. Method. We used a five-step framework to develop the text messages used in Reach Out. These steps included literature review and community formative research, conception of a community-centered behavioral theoretical framework, draft of evidence-based text messages, community review, and revision based on community feedback and finalization. Results . The Reach Out development process drew from pertinent evidence that, combined with community feedback, guided the development of a community-centered health behavior theory framework that led to development of text messages. A total of 333 generic and segmented messages were created. Messages address dietary choices, physical activity, hypertension medication adherence, and blood pressure monitoring. Discussion. Our five-step framework is intended to inform future text-messaging-based health promotion efforts to address health issues in vulnerable populations. Conclusion . Text message-based health promotion programs should be developed in partnership with the local community to ensure acceptability and relevance.",2020,"Due to the ubiquitous nature of mobile phone usage, text messaging offers a promising platform for interventions to assist in the management of chronic diseases including hypertension, including among populations that are historically underserved.","['Reach Out Emergency Department', 'hypertensive patients evaluated in a safety net emergency department primarily caring for African Americans']",[],"['physical activity, hypertension medication adherence, and blood pressure monitoring', 'blood pressure', 'Hypertension']","[{'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0026426', 'cui_str': 'Blood pressure monitoring'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",333.0,0.0398859,"Due to the ubiquitous nature of mobile phone usage, text messaging offers a promising platform for interventions to assist in the management of chronic diseases including hypertension, including among populations that are historically underserved.","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Champoux', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Price', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Joan E', 'Initials': 'JE', 'LastName': 'Cowdery', 'Affiliation': 'Eastern Michigan University, Ypsilanti, MI, USA.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Dinh', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Meurer', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Narmeen', 'Initials': 'N', 'LastName': 'Rehman', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Schille', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Oliver', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Devin L', 'Initials': 'DL', 'LastName': 'Brown', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Killingsworth', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Lesli E', 'Initials': 'LE', 'LastName': 'Skolarus', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}]",Health promotion practice,['10.1177/1524839920913550'] 168,32240370,Sustained remission of child depression despite drift in parent emotion management skills 18 weeks following Parent Child Interaction Therapy: emotion development.,"Whether effects of psychotherapies for depression are sustained after treatment is an important clinical issue. In older depressed children and adolescents such treatments have been shown to be sustained for several months. Rates of remission ranged from 62-69% at 3 months-1 year in one large scale study. To date there has been no data to inform whether the effects of earlier interventions for depression in the preschool period are sustained. To address this, we used data from a randomized controlled trial of a novel early intervention for depression called ""Parent Child Interaction Therapy Emotion Development"" (PCIT-ED) that has shown efficacy for depression, parenting stress and parenting practices. Participants and their caregivers were re-assessed 18 weeks after treatment completion. All study procedures were approved by the Washington University School of Medicine Internal Review Board prior to data collection. Study findings demonstrated a high rate of sustained gains in remission from depression, decreased parenting stress and parental depression 18 weeks after completion of a trial of PCIT-ED in a population of young children. Parental response to the child expression of emotion, a key treatment target drifted back towards baseline after 3 months. Relapse rates were 17% and predictors of relapse were the presence of an externalizing disorder, a higher number of co-morbid disorders and poorer guilt reparation and emotion regulation measured at treatment completion. This extends the body of literature demonstrating parent-child interaction therapy (PCIT) to have sustained effects on targeted disruptive symptom profiles to early childhood depression. This relatively low relapse rate after 18 weeks is comparable or better than many empirically proven treatments for depression in older children.",2021,"Study findings demonstrated a high rate of sustained gains in remission from depression, decreased parenting stress and parental depression 18 weeks after completion of a trial of PCIT-ED in a population of young children.","['older children', 'All study procedures were approved by the Washington University School of Medicine Internal Review Board prior to data collection']","['PCIT-ED', 'parent-child interaction therapy (PCIT', 'psychotherapies', 'novel early intervention for depression called ""Parent Child Interaction Therapy Emotion Development"" (PCIT-ED']","['Rates of remission', 'Relapse rates', 'number of co-morbid disorders and poorer guilt reparation and emotion regulation']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}]","[{'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0018379', 'cui_str': 'Feeling guilt'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",,0.0754405,"Study findings demonstrated a high rate of sustained gains in remission from depression, decreased parenting stress and parental depression 18 weeks after completion of a trial of PCIT-ED in a population of young children.","[{'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Luby', 'Affiliation': 'Washington University School of Medicine, Child Psychiatry, St. Louis, MO, 63130, USA. lubyj@wustl.edu.'}, {'ForeName': 'Meghan Rose', 'Initials': 'MR', 'LastName': 'Donohue', 'Affiliation': 'Washington University School of Medicine, Child Psychiatry, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Gilbert', 'Affiliation': 'Washington University School of Medicine, Child Psychiatry, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Tillman', 'Affiliation': 'Washington University School of Medicine, Child Psychiatry, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Deanna M', 'Initials': 'DM', 'LastName': 'Barch', 'Affiliation': 'Department of Psychological and Brain Sciences, Washington University in St. Louis, St. Louis, MO, 63130, USA.'}]",European child & adolescent psychiatry,['10.1007/s00787-020-01522-7'] 169,32238297,Improving Social Connectedness for Homebound Older Adults: Randomized Controlled Trial of Tele-Delivered Behavioral Activation Versus Tele-Delivered Friendly Visits.,"OBJECTIVE To test the acceptability and effectiveness of a lay-coach-facilitated, videoconferenced, short-term behavioral activation (Tele-BA) intervention for improving social connectedness among homebound older adults. METHODS We employed a two-site, participant-randomized controlled trial with 89 older adults (averaging 74 years old) who were recipients of, and initially screened by, home-delivered meals programs. All participants reported loneliness; many reported being socially isolated and/or dissatisfaction with social support. Participants received five weekly videoconference sessions of either Tele-BA or Tele-FV (friendly visits; active control). Three primary outcomes were social interaction (Duke Social Support Index [DSSI] Social Interaction Subscale), subjective loneliness (PROMIS Social Isolation Scale), and DSSI Satisfaction with Social Support Subscale. Depression severity (PHQ-9) and disability (WHODAS 2.0) were secondary outcomes. Mixed-effects regression models were fit to evaluate outcomes at 6- and 12-weeks follow-up. RESULTS Compared to Tele-FV participants, Tele-BA participants had greater increase in social interaction (t [81] = 2.42, p = 0.018) and satisfaction with social support (t [82] = 2.00, p = 0.049) and decrease in loneliness (t [81] = -3.08, p = 0.003), depression (t [82] = -3.46, p = 0.001), and disability (t [81] = -2.29, p = 0.025). CONCLUSION A short-term, lay-coach-facilitated Tele-BA is a promising intervention for the growing numbers of homebound older adults lacking social connectedness. The intervention holds promise for scalability in programs that already serve homebound older adults. More research is needed to solidify the clinical evidence base, cost-effectiveness and sustainability of Tele-BA delivered by lay coaches for homebound and other older adults.",2020,"Compared to Tele-FV participants, Tele-BA participants had greater increase in social interaction (t [81] = 2.42, p = 0.018) and satisfaction with social support (t [82] = 2.00, p = 0.049) and decrease in loneliness (t [81] = -3.08, p = 0.003), depression (t [82] = -3.46, p = 0.001), and disability (t [81] = -2.29, p = 0.025). ","['89 older adults (averaging 74 years old) who were recipients of, and initially screened by, home-delivered meals programs', 'homebound older adults', 'Homebound Older Adults']","['lay-coach-facilitated, videoconferenced, short-term behavioral activation (Tele-BA) intervention', 'videoconference sessions of either Tele-BA or Tele-FV (friendly visits; active control', 'Tele-Delivered Behavioral Activation Versus Tele-Delivered Friendly Visits', 'lay-coach-facilitated Tele-BA']","['Depression severity (PHQ-9) and disability', 'depression', 'social interaction (Duke Social Support Index [DSSI] Social Interaction Subscale), subjective loneliness (PROMIS Social Isolation Scale), and DSSI Satisfaction with Social Support Subscale', 'disability', 'loneliness', 'satisfaction with social support', 'social interaction']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0242798', 'cui_str': 'Home-Bound Persons'}]","[{'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1515258', 'cui_str': 'Telephone number (property)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C1512090', 'cui_str': 'Dukes staging system'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",89.0,0.0496621,"Compared to Tele-FV participants, Tele-BA participants had greater increase in social interaction (t [81] = 2.42, p = 0.018) and satisfaction with social support (t [82] = 2.00, p = 0.049) and decrease in loneliness (t [81] = -3.08, p = 0.003), depression (t [82] = -3.46, p = 0.001), and disability (t [81] = -2.29, p = 0.025). ","[{'ForeName': 'Namkee G', 'Initials': 'NG', 'LastName': 'Choi', 'Affiliation': 'The University of Texas at Austin, Steve Hicks School of Social Work (NGC, CNM), Austin, TX. Electronic address: nchoi@austin.utexas.edu.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Pepin', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Dartmouth-Hitchcock Health (RP, CJS, MLB), Hanover, NH.'}, {'ForeName': 'C Nathan', 'Initials': 'CN', 'LastName': 'Marti', 'Affiliation': 'The University of Texas at Austin, Steve Hicks School of Social Work (NGC, CNM), Austin, TX.'}, {'ForeName': 'Courtney J', 'Initials': 'CJ', 'LastName': 'Stevens', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Dartmouth-Hitchcock Health (RP, CJS, MLB), Hanover, NH.'}, {'ForeName': 'Martha L', 'Initials': 'ML', 'LastName': 'Bruce', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Dartmouth-Hitchcock Health (RP, CJS, MLB), Hanover, NH.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.02.008'] 170,32238795,Longitudinal effects of a nurse-managed comprehensive cardiovascular disease prevention program for hospitalized coronary heart disease patients and primary care high-risk patients.,"BACKGROUND The EUROACTION study (nurse‑coordinated multidisciplinary, family‑based cardiovascular disease prevention program) documented the efficacy of a nurse‑managed, comprehensive prevention program in reducing risk factors for cardiovascular disease (CVD). No information was available on survival. AIMS The aim of the study was to assess the effects of EUROACTION intervention on CVD risk factors and 12‑year survival in the Polish component of the study. METHODS Two district hospitals and 2 primary care practices were allocated randomly to intervention (INT) or usual care (UC). The primary endpoints were lifestyle and risk factors changes at 1‑year follow‑up. Differences in survival were analyzed using the multivariable Cox proportional hazards regression models. RESULTS The study involved 628 patients with coronary heart disease (CHD) and 711 high‑risk patients. Compared to UC, INT patients achieved healthier lifestyles and a larger reduction of risk factors at 1 year but these differences were not maintained 12 years after the intervention. Less deaths occurred in patients from the INT hospital and from INT primary practice (hazard ratio [HR], 0.58; 95% CI, 0.42-0.82 and HR, 0.53; 95% CI, 0.3-0.95, respectively). Adjustment for the covariates slightly attenuated the estimates and removed significance (HR, 0.74; 95% CI, 0.52-1.04 and HR, 0.66; 95% CI, 0.36-1.24, respectively). For combined CHD and high‑risk patient groups, compared with UC, INT patients had a 36% lower risk of death after adjustment for age, sex, and history of CHD (HR, 0.64; 95% CI, 0.48-0.86). CONCLUSIONS The impact of the EUROACTION intervention on lifestyle and CVD risk factors could have contributed to lower mortality in INT coronary and high‑risk patients. These results emphasize the need for sustaining the interventions to help patients maintain a healthy lifestyle.",2020,"Compared to UC, INT patients achieved healthier life styles and a larger reduction of risk factors at 1 year but these differences were not maintained 12 years after intervention.","['Two district hospitals and two primary practices', '628 CHD patients and 601 high-risk patients', 'hospitalized coronary heart disease patients and primary care high-risk patients']","['nurse managed, comprehensive prevention programme', 'nurse-managed comprehensive cardiovascular disease prevention programme', 'intervention (INT) or usual care (UC']","['survival', 'healthier life styles', 'Less deaths', 'CVD risk factors', 'risk factors', 'lifestyle and risk factors changes at 1 year observation', 'risk of death']","[{'cui': 'C0020006', 'cui_str': 'District hospital'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",628.0,0.0552067,"Compared to UC, INT patients achieved healthier life styles and a larger reduction of risk factors at 1 year but these differences were not maintained 12 years after intervention.","[{'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Pająk', 'Affiliation': 'Department of Epidemiology and Population Studies, Jagiellonian University Medical College, Kraków, Poland. andrzej.pajak@uj.edu.pl'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Wolfshaut-Wolak', 'Affiliation': 'Department of Epidemiology and Population Studies, Jagiellonian University Medical College, Kraków, Poland'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Doryńska', 'Affiliation': 'Department of Epidemiology and Population Studies, Jagiellonian University Medical College, Kraków, Poland'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Jankowski', 'Affiliation': '1st Department of Cardiology and Intervention Electrocardiology and Hypertension, Jagiellonian University Medical College, Kraków, Poland'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Fornal', 'Affiliation': 'Department of Internal Medicine and Gerontology, Jagiellonian University Medical College, Kraków, Poland'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Grodzicki', 'Affiliation': 'Department of Internal Medicine and Gerontology, Jagiellonian University Medical College, Kraków, Poland'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'Jennings', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, United Kingdom; National Institute for Prevention and Cardiovascular Health, National University of Ireland, Galway, Republic of Ireland'}, {'ForeName': 'Kalina', 'Initials': 'K', 'LastName': 'Kawecka-Jaszcz', 'Affiliation': '1st Department of Cardiology and Intervention Electrocardiology and Hypertension, Jagiellonian University Medical College, Kraków, Poland'}, {'ForeName': 'Kornelia', 'Initials': 'K', 'LastName': 'Kotseva', 'Affiliation': 'Imperial College Healthcare NHS Trust, London, United Kingdom; National Institute for Prevention and Cardiovascular Health, National University of Ireland, Galway, Republic of Ireland'}, {'ForeName': 'Krystyna', 'Initials': 'K', 'LastName': 'Pająk', 'Affiliation': 'Centre of Preventive Medicine, Kraków, Poland'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wood', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, United Kingdom; National Institute for Prevention and Cardiovascular Health, National University of Ireland, Galway, Republic of Ireland'}]",Kardiologia polska,['10.33963/KP.15273'] 171,32249513,Mobility Assessment under Dual Task Conditions in Women With Fibromyalgia: A Test-Retest Reliability Study.,"OBJECTIVE To assess the test-retest reliability of the 10-step stair ascent test, Timed Up and Go (TUG) test, and 10-meter walking test under dual-task conditions in patients with fibromyalgia. DESIGN Test-retest reliability. SETTINGS Local fibromyalgia association and university facilities. PARTICIPANTS Thirty-eight women with fibromyalgia. INTERVENTIONS Not applicable. MAIN OUTCOME MEASURES Fear of falling and the number of falls in the last year were measured using a visual analogue scale. The 10-step stair ascent test, TUG test, and 10-meter walking test were conducted under single- and dual-task conditions. The order between single- and dual-task condition was randomized in both test and retest. Retest measurement was assessed the week following the test. RESULTS The reliability of the performance on the 10-step stair ascent test under dual and single conditions ranged between good (>0.75 to < 0.9) and excellent (≥0.9), but there were significant differences between test and retest. The reliability of the TUG is between good (≥0.75 to < 0.9) and excellent (≥0.9) under the dual-task condition as well as moderate (≥0.5 to <0.75) and excellent (≥0.9) under the single-task condition. The reliability of the 10-meter walking dual-task test is between moderate (≥0.5 to <0.75) and good (≥0.75 to < 0.9) under dual- and single-task condition, respectively. CONCLUSIONS The TUG and 10-meter walking tests are reliable for assessing mobility under the dual-task condition in women with fibromyalgia. The performance on the TUG, 10-step stair ascent, and 10-meter walking test under single- and dual-task conditions was significantly related to fear of falling. These results may help healthcare professionals and researchers to interpret the effect of interventions in women with fibromyalgia.",2021,"The reliability of the 10-m walking dual test are between moderate (>0.5 and < 0.75) and good (>0.75 and < 0.9) under dual and single-task condition respectively. ","['patients with fibromyalgia', 'Local fibromyalgia association and university facilities', 'women with fibromyalgia', 'Women with Fibromyalgia', '38 women with fibromyalgia']","['Mobility Assessment under Dual Task Conditions', '10-step stair ascent test, TUG test and 10-m walking test under dual task conditions']","['fear of falling', 'Fear of falling and the number of falls in the last year were measured using a visual analogue scale', '10-step stair ascent test, TUG test and 10-m walking test', 'TUGt, 10-step stairs ascent and 10-m walking tests under single and dual-task conditions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C2317515', 'cui_str': 'Assessment of mobility'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}]","[{'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",38.0,0.02095,"The reliability of the 10-m walking dual test are between moderate (>0.5 and < 0.75) and good (>0.75 and < 0.9) under dual and single-task condition respectively. ","[{'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Murillo-Garcia', 'Affiliation': 'Physical Activity and Quality of Life Research Group (AFYCAV), Faculty of Sport Science, University of Extremadura, Cáceres, Spain.'}, {'ForeName': 'Santos', 'Initials': 'S', 'LastName': 'Villafaina', 'Affiliation': 'Physical Activity and Quality of Life Research Group (AFYCAV), Faculty of Sport Science, University of Extremadura, Cáceres, Spain.'}, {'ForeName': 'Juan Luis', 'Initials': 'JL', 'LastName': 'Leon-Llamas', 'Affiliation': 'Physical Activity and Quality of Life Research Group (AFYCAV), Faculty of Sport Science, University of Extremadura, Cáceres, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Sánchez-Gómez', 'Affiliation': 'Physical Activity and Quality of Life Research Group (AFYCAV), Faculty of Sport Science, University of Extremadura, Cáceres, Spain.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Domínguez-Muñoz', 'Affiliation': 'Physical Activity and Quality of Life Research Group (AFYCAV), Faculty of Sport Science, University of Extremadura, Cáceres, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Collado-Mateo', 'Affiliation': 'Centre for Sport Studies, Rey Juan Carlos University, Fuenlabrada, Spain.'}, {'ForeName': 'Narcis', 'Initials': 'N', 'LastName': 'Gusi', 'Affiliation': 'Physical Activity and Quality of Life Research Group (AFYCAV), Faculty of Sport Science, University of Extremadura, Cáceres, Spain.'}]","PM & R : the journal of injury, function, and rehabilitation",['10.1002/pmrj.12375'] 172,32250132,A randomized study on the efficacy of the Social Cognition Training Program-brief version in a sample of patients with schizophrenia.,"OBJECTIVE In recent years, various interventions have been developed to train social cognition in schizophrenia, which have been shown to be effective in improving emotional processing, theory of mind and social perception, as well as community functioning. One of these interventions is the Social Cognition Training Program (SCTP), a program consisting of 24 sessions. For the present study we developed a brief version of 12 sessions with the aim to improve its applicability. To evaluate the effectiveness of this version, a randomized controlled trial was conducted comparing the SCTP to a neurocognitive training. METHOD The trial was conducted with a sample of 299 patients with schizophrenia, with assessments conducted at baseline, posttreatment, and 6- and 12-month follow up. The assessment protocol included tests of emotion recognition, theory of mind, attributional style, symptomatology, community functioning, and neurocognitive functioning. RESULTS The results obtained showed that the patients of the experimental group improved in the recognition of the emotions of sadness, anger, and fear, and in the first- and second-order theory of mind. However, no significant improvement was observed in the measures of community functioning. Improvements in first- and second-order theory of mind but not emotion recognition persisted at follow ups. CONCLUSIONS AND IMPLICATIONS FOR PRACTICE Results obtained showed that deficits in social cognition can be ameliorated, although it could be necessary to have booster sessions to maintain the benefits of the training and to complement the SCPT with another type of interventions aimed specifically at transferring the benefits of social cognition training to ""real"" life. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"The results obtained showed that the patients of the experimental group improved in the recognition of the emotions of sadness, anger, and fear, and in the first- and second-order theory of mind.","['299 patients with schizophrenia, with assessments conducted at baseline, posttreatment, and 6- and 12-month follow up', 'patients with schizophrenia']","['SCTP', 'Social Cognition Training Program (SCTP', 'Social Cognition Training Program-brief version']","['emotion recognition, theory of mind, attributional style, symptomatology, community functioning, and neurocognitive functioning', 'community functioning', 'recognition of the emotions of sadness, anger, and fear']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C2607870', 'cui_str': 'Version'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0935573', 'cui_str': 'Theory of Mind'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C3536794', 'cui_str': 'Unhappiness'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]",299.0,0.0168544,"The results obtained showed that the patients of the experimental group improved in the recognition of the emotions of sadness, anger, and fear, and in the first- and second-order theory of mind.","[{'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Fernández-Modamio', 'Affiliation': 'Department of Clinical Psychology.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gil-Sanz', 'Affiliation': 'Department of Clinical Psychology.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Arrieta-Rodríguez', 'Affiliation': 'Department of Clinical Psychology.'}, {'ForeName': 'Iciar', 'Initials': 'I', 'LastName': 'Santacoloma-Cabero', 'Affiliation': 'Department of Clinical Psychology.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Bengochea-Seco', 'Affiliation': 'Department of Clinical Psychology.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'González-Fraile', 'Affiliation': 'Faculty of Psychology.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Muñiz', 'Affiliation': 'Faculty of Psychology.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Psychiatric rehabilitation journal,['10.1037/prj0000410'] 173,32246153,"Sleep problems in active duty military personnel seeking treatment for posttraumatic stress disorder: presence, change, and impact on outcomes.","STUDY OBJECTIVES To examine sleep disorder symptom reports at baseline and posttreatment in a sample of active duty U.S. Army Soldiers receiving treatment for posttraumatic stress disorder (PTSD). Explore sleep-related predictors of outcomes. METHODS Sleep was evaluated in 128 participants in a parent randomized clinical trial comparing Spaced formats of Prolonged Exposure (PE) or Present Centered Therapy and a Massed format of PE. In the current study, Spaced formats were combined and evaluated separately from Massed. RESULTS At baseline, the average sleep duration was < 5 h per night on weekdays/workdays and < 6 h per night on weekends/off days. The majority of participants reported clinically significant insomnia, clinically significant nightmares, and probable sleep apnea and approximately half reported excessive daytime sleepiness at baseline. Insomnia and nightmares improved significantly from baseline to posttreatment in all groups, but many patients reported clinically significant insomnia (>70%) and nightmares (>38%) posttreatment. Excessive daytime sleepiness significantly improved only in the Massed group, but 40% continued to report clinically significant levels at posttreatment. Short sleep (Spaced only), clinically significant insomnia and nightmares, excessive daytime sleepiness, and probable sleep apnea (Massed only) at baseline predicted higher PTSD symptoms across treatment course. Short weekends/off days sleep predicted lower PTSD symptom improvement in the Spaced treatments. CONCLUSIONS Various sleep disorder symptoms were high at baseline, were largely unchanged with PTSD treatment, and were related to worse PTSD treatment outcomes. Studies are needed with objective sleep assessments and targeted sleep disorders treatments in PTSD patients. CLINICAL TRIAL REGISTRATION NCT01049516.",2020,"Insomnia and nightmares improved significantly from baseline to posttreatment in all groups, but many patients reported clinically significant insomnia (> 70%) and nightmares (> 38%) posttreatment.","['Sleep was evaluated in 128 participants in a parent randomized clinical trial comparing', 'PTSD patients', 'Posttraumatic Stress Disorder', 'a sample of active duty U.S. Army Soldiers receiving treatment for posttraumatic stress disorder (PTSD']",['Spaced formats of Prolonged Exposure (PE) or Present Centered Therapy and a Massed format of PE'],"['Insomnia and nightmares', 'PTSD symptoms', 'Various sleep disorder symptoms', 'excessive daytime sleepiness', 'Excessive daytime sleepiness', 'average sleep duration', 'Short sleep (Spaced only), clinically significant insomnia and nightmares, excessive daytime sleepiness and probable sleep apnea', 'probable sleep apnea', 'Sleep Problems', 'PTSD symptom improvement']","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0524647', 'cui_str': 'Soldiers'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0028084', 'cui_str': 'Nightmares'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C4551761', 'cui_str': 'Excessive daytime sleepiness'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}]",128.0,0.0245555,"Insomnia and nightmares improved significantly from baseline to posttreatment in all groups, but many patients reported clinically significant insomnia (> 70%) and nightmares (> 38%) posttreatment.","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Taylor', 'Affiliation': 'Department of Psychology, University of North Texas, Denton, TX.'}, {'ForeName': 'Kristi E', 'Initials': 'KE', 'LastName': 'Pruiksma', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Willie', 'Initials': 'W', 'LastName': 'Hale', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Carmen P', 'Initials': 'CP', 'LastName': 'McLean', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Healthcare System, Menlo Park, CA.'}, {'ForeName': 'Laurie J', 'Initials': 'LJ', 'LastName': 'Zandberg', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Mintz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Young-McCaughan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Yarvis', 'Affiliation': 'Department of Behavioral Health, Carl R. Darnall Army Medical Center, Fort Hood, TX.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Dondanville', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Brett T', 'Initials': 'BT', 'LastName': 'Litz', 'Affiliation': 'Massachusetts Veterans Epidemiology Research and Information Center, VA Boston Healthcare System, Boston, MA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Roache', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Edna B', 'Initials': 'EB', 'LastName': 'Foa', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA.'}]",Sleep,['10.1093/sleep/zsaa065'] 174,32241351,"The effects of a clinically feasible application of low-level laser therapy on the rate of orthodontic tooth movement: A triple-blind, split-mouth, randomized controlled trial.","INTRODUCTION This split-mouth trial aimed to investigate the effect of low-level laser therapy (LLLT) on the amount of maxillary canine distalization when applied every 4 weeks over 12 weeks. METHODS Twenty-two adolescents and young adults (15 female, 7 male; aged 13-25 years; n = 22) requiring bilateral maxillary first premolar extractions were recruited. After extractions and leveling-alignment, canines were retracted using closed-coil nickel-titanium springs delivering 150 g of force. LLLT was applied to 8 intraoral points on the buccal and palatal sides around the canine root for 10 seconds per point, on day 0, 28, and 56 with the control side receiving sham application. Alginate impressions were taken every 4 weeks on day 0, 28, 56, and 84. The amount of tooth movement, anchorage loss, and canine rotation were measured digitally. Randomization was generated using www.randomisation.com and allocation concealment through sequentially numbered, opaque, sealed envelopes. Participants, operator, and statistic assessor were blinded. Linear regression modeling accounting for clustering within each patient was used to identify differences between LLLT and control sides. RESULTS Twenty-one patients completed the study. The total amount of tooth movement was similar in the LLLT (2.55 ± 0.73 mm) and control group (2.30 ± 0.86 mm), whereas 0.25 mm (95% confidence interval, -0.21, 0.71 mm) of difference was insignificant (P = 0.27). No significant differences were found for anchorage loss (P = 0.22) or canine rotation (P = 0.25). No harms were reported. CONCLUSIONS Application of LLLT every 4 weeks did not result in differences in the amount of tooth movement, anchorage loss, and canine rotation during extraction space closure.",2020,No significant differences were found for anchorage loss (P = 0.22) or canine rotation (P = 0.25).,"['Twenty-two adolescents and young adults (15 female, 7 male; aged 13-25\xa0years; n\xa0=\xa022) requiring bilateral maxillary first premolar extractions were recruited', 'Twenty-one patients completed the study']","['LLLT', 'low-level laser therapy', 'low-level laser therapy (LLLT']","['total amount of tooth movement', 'canine rotation', 'anchorage loss', 'amount of tooth movement, anchorage loss, and canine rotation', 'rate of orthodontic tooth movement']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040446', 'cui_str': 'Orthodontic Tooth Movement'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]",22.0,0.446363,No significant differences were found for anchorage loss (P = 0.22) or canine rotation (P = 0.25).,"[{'ForeName': 'Dipika', 'Initials': 'D', 'LastName': 'Mistry', 'Affiliation': 'Faculty of Medicine and Health, Department of Orthodontics, Discipline of Orthodontics and Paediatric Dentistry, School of Dentistry, University of Sydney, Sydney Dental Hospital, Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Oyku', 'Initials': 'O', 'LastName': 'Dalci', 'Affiliation': 'Faculty of Medicine and Health, Department of Orthodontics, Discipline of Orthodontics and Paediatric Dentistry, School of Dentistry, University of Sydney, Sydney Dental Hospital, Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Spyridon N', 'Initials': 'SN', 'LastName': 'Papageorgiou', 'Affiliation': 'Center of Dental Medicine, Clinic of Orthodontics and Paediatric Dentistry, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'M Ali', 'Initials': 'MA', 'LastName': 'Darendeliler', 'Affiliation': 'Faculty of Medicine and Health, Department of Orthodontics, Discipline of Orthodontics and Paediatric Dentistry, School of Dentistry, University of Sydney, Sydney Dental Hospital, Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Alexandra K', 'Initials': 'AK', 'LastName': 'Papadopoulou', 'Affiliation': 'Faculty of Medicine and Health, Department of Orthodontics, Discipline of Orthodontics and Paediatric Dentistry, School of Dentistry, University of Sydney, Sydney Dental Hospital, Sydney Local Health District, Sydney, New South Wales, Australia. Electronic address: alexandra.papadopoulou@sydney.edu.au.'}]","American journal of orthodontics and dentofacial orthopedics : official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics",['10.1016/j.ajodo.2019.12.005'] 175,31298494,The effect of sacral massage on labor pain and anxiety: A randomized controlled trial.,"AIM Nonpharmacologic pain control methods, which are increasingly becoming widespread in coping with labor pain, are the methods that allow women to completely relax without using any medication and direct them to perceive the pain at the lowest level. This study was conducted to determine the effect of sacral massage on labor pain and anxiety. METHODS This study was conducted as a randomized controlled experimental study at Bağcılar Hospital, Obstetrics and Gynecology Clinic between March and October 2016. In all, 60 women, 30 of whom were in the control group and 30 of whom were in the experimental group, constituted the research sample. The women in the experimental group were administered a massage to the sacral region for 30 min. The questionnaire form, birth action follow-up form, postpartum interview form, visual analog scale (VAS) and state-trait anxiety inventory were used to collect data in the study. RESULTS The latent phase VAS averages (3.57 ± 1.43), active phase VAS averages (7.03 ± 1.5) and transition phase VAS averages (8.83 ± 1.78) of the experimental group were found to be statistically significantly lower than those of the control group (P < .05). CONCLUSION It was concluded that sacral massage applied during labor reduced women's labor pain, lowered the levels of concern and anxiety, led to greater feelings of satisfaction among pregnant women in terms of labor, positively affected the perception of labor and had no fetal side effects.",2020,"It was concluded that sacral massage applied during labor reduced women's labor pain, lowered the levels of concern and anxiety, led to greater feelings of satisfaction among pregnant women in terms of labor, positively affected the perception of labor and had no fetal side effects.","['60 women, 30 of whom were in the control group and 30 of whom were in the experimental group, constituted the research sample', 'Bağcılar Hospital, Obstetrics and Gynecology Clinic between March and October 2016']",['sacral massage'],"['levels of concern and anxiety', 'labor pain', 'latent phase VAS averages', 'labor pain and anxiety', 'transition phase VAS averages', 'feelings of satisfaction', 'questionnaire form, birth action follow-up form, postpartum interview form, visual analog scale (VAS) and state-trait anxiety inventory', 'active phase VAS averages']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C3840245', 'cui_str': 'Obstetrics and gynecology clinic'}]","[{'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0474368', 'cui_str': 'Labor Pain'}, {'cui': 'C0205275', 'cui_str': 'Latent (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]",60.0,0.0667728,"It was concluded that sacral massage applied during labor reduced women's labor pain, lowered the levels of concern and anxiety, led to greater feelings of satisfaction among pregnant women in terms of labor, positively affected the perception of labor and had no fetal side effects.","[{'ForeName': 'Semra', 'Initials': 'S', 'LastName': 'Akköz Çevik', 'Affiliation': 'Obstetric and Gyneacologic Nursing Department, Gaziantep University of Faculty of Health Sciences, Gaziantep, Turkey.'}, {'ForeName': 'Serap', 'Initials': 'S', 'LastName': 'Karaduman', 'Affiliation': 'Obstetric Department, Bağcılar Training and Research Hospital, Istanbul, Turkey.'}]",Japan journal of nursing science : JJNS,['10.1111/jjns.12272'] 176,31464577,Treatment of symptomatic degenerative intervertebral discs with autologous platelet-rich plasma: follow-up at 5-9 years.,"Aim: This study assessed pain and function at 5-9 years postinjection in a subset of patients who received intradiscal platelet-rich plasma (PRP) injections for moderate-to-severe lumbar discogenic pain. Patients & methods: All patients received injections of intradiscal PRP in a previous randomized controlled trial. Data on pain, function, satisfaction, and need for surgery were collected at one time point of 5-9 years postinjection and compiled with existing data. Results: In comparison to baseline, there were statistically significant improvements in pain and function (p < 0.001). All improvements were clinically significant. Six patients had undergone surgery during the follow-up period. Conclusion: This subset of patients demonstrated statistically and clinically significant improvements in pain and function at 5-9 years postinjection.",2019,"In comparison to baseline, there were statistically significant improvements in pain and function (p < 0.001).","['for moderate-to-severe lumbar discogenic pain', 'Six patients had undergone surgery during the follow-up period']","['autologous platelet-rich plasma', 'intradiscal platelet-rich plasma (PRP) injections', 'injections of intradiscal PRP']","['pain and function', 'pain, function, satisfaction, and need for surgery']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C3662826', 'cui_str': 'Lumbar discogenic pain (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",,0.114452,"In comparison to baseline, there were statistically significant improvements in pain and function (p < 0.001).","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'Department of Physiatry, Hospital for Special Surgery, 535 East 70th Street, New York, NY 10021, USA.'}, {'ForeName': 'Kristen A', 'Initials': 'KA', 'LastName': 'Santiago', 'Affiliation': 'Department of Physiatry, Hospital for Special Surgery, 535 East 70 Street, New York, NY 10021, USA.'}, {'ForeName': 'Joseph T', 'Initials': 'JT', 'LastName': 'Nguyen', 'Affiliation': 'Healthcare Research Institute, Hospital for Special Surgery, 535 East 70th Street, New York, NY 10021, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Solomon', 'Affiliation': 'Department of Physiatry, Hospital for Special Surgery, 535 East 70 Street, New York, NY 10021, USA.'}, {'ForeName': 'Gregory E', 'Initials': 'GE', 'LastName': 'Lutz', 'Affiliation': 'Department of Physiatry, Hospital for Special Surgery, 535 East 70 Street, New York, NY 10021, USA.'}]",Regenerative medicine,['10.2217/rme-2019-0040'] 177,31965675,Effectiveness of behaviour change techniques on lifestyle interventions of patients with a high risk of developing cardiovascular disease. Using a qualitative approach.,"This study aimed to identify key active ingredients on the maintenance of behaviour change for lifestyle interventions of patients with a high risk of developing cardiovascular disease (CVD) who participated in a MOtiVational intErviewing InTervention (MOVE IT) randomised control trial (RCT). A process evaluation was carried out using focus groups. Twenty-six participants of the MOVE IT RCT were purposively recruited and split into six focus groups. Four groups had attended six or more sessions of the intensive phase (completers) and two groups had withdrawn before the end of the intensive phase or had not attended any sessions (non-completers). Focus groups were audio recorded, transcribed verbatim and analysed inductively using thematic analysis. Three overall themes were generated from the six focus groups: (a) long-term benefits from diet and physical activity education, (b) group versus individual structure and adherence and (c) impact on health beliefs and risk of CVD. A fourth theme was generated from the two groups of non-completers only: (d) need for professional rapport building and feedback. We found that the key active ingredients for effective behavioural change in lifestyle interventions are having well-developed rapport between facilitators and patients; and providing alternative forms of feedback to encourage maintenance of behaviour change. Furthermore, such programmes also need to have established and strong relationships with associated health professionals (i.e. the General Practitioner) to increase participation and maintenance of engagement.",2020,We found that the key active ingredients for effective behavioural change in lifestyle interventions are having well-developed rapport between facilitators and patients; and providing alternative forms of feedback to encourage maintenance of behaviour change.,"['Twenty-six participants of the MOVE IT RCT', 'Four groups had attended six or more sessions of the intensive phase (completers) and two groups had withdrawn before the end of the intensive phase or had not attended any sessions (non-completers', 'patients with a high risk of developing cardiovascular disease (CVD) who participated in a MOtiVational intErviewing InTervention (MOVE IT) randomised control trial (RCT', 'patients with a high risk of developing cardiovascular disease']",['behaviour change techniques'],['health beliefs and risk of CVD'],"[{'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0559294', 'cui_str': 'Not attended'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0814098', 'cui_str': 'Health belief'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",26.0,0.0302038,We found that the key active ingredients for effective behavioural change in lifestyle interventions are having well-developed rapport between facilitators and patients; and providing alternative forms of feedback to encourage maintenance of behaviour change.,"[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Kuriakose', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Kuczynska', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Timpel', 'Affiliation': 'Department for Prevention and Care of Diabetes, Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Yakub', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bayley', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Iliatha', 'Initials': 'I', 'LastName': 'Papachristou Nadal', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]",Health & social care in the community,['10.1111/hsc.12933'] 178,32171945,"Acute radiation-induced skin toxicity in hypofractionated vs. conventional whole-breast irradiation: An objective, randomized multicenter assessment using spectrophotometry.","PURPOSE Radiation dermatitis represents one of the most frequent side effects in breast cancer patients undergoing adjuvant whole-breast irradiation (WBI). Whether hypofractionated WBI induces comparable or less acute radiation-induced skin reactions than conventional WBI is still not fully clarified, as randomized evidence and objective assessments are limited. The aim of this study was to objectively determine frequency and severity of acute radiation-induced skin reactions during hypofractionated vs. conventionally fractionated adjuvant WBI. METHODS In this randomized multicenter study, a total of 140 breast cancer patients underwent either hypofractionated or conventional WBI following breast-preserving surgery. Maximum radiation dermatitis severity was assessed at completion and during follow-up by physician-assessed CTCAE v4.03 and the patient-reported RISRAS scale. Additionally, photospectrometric skin readings were performed to objectify skin color differences between both treatment arms. RESULTS Radiation dermatitis severity was significantly lower in patients receiving hypofractionation compared with conventional fractionation (mean 1.05 vs. 1.43, p = .024). Grade 0 radiation dermatitis occurred in 21.43% vs. 4.28%, grade ≥2 in 27.14% vs. 42.91% and grade ≥3 in 0% vs. 4.34% of patients following hypofractionated and conventional WBI, respectively. Objective photospectrometric measurements (n = 4200) showed both decreased erythema severity (p = .008) and hyperpigmentation (p = .002) in the hypofractionation arm. Patients allocated to hypofractionated WBI also reported less pain (p = .006), less hyperpigmentation (p = <0.001) and less limitations of day-to-day activities (p = <0.001). CONCLUSION Physician and patient-assessed toxicity scorings as well as objective photospectrometric skin measurements revealed that hypofractionated WBI yielded lower rates and severity of acute radiation-induced skin toxicity.",2020,"Patients allocated to hypofractionated WBI also reported less pain (p = .006), less hyperpigmentation (p = <0.001) and less limitations of day-to-day activities (p = <0.001). ","['140 breast cancer patients underwent either', 'breast cancer patients undergoing adjuvant whole-breast irradiation (WBI']","['spectrophotometry', 'hypofractionated or conventional WBI following breast-preserving surgery', 'hypofractionated vs. conventionally fractionated adjuvant WBI', 'Acute radiation-induced skin toxicity in hypofractionated vs. conventional whole-breast irradiation']","['Maximum radiation dermatitis severity', 'photospectrometric skin readings', 'Radiation dermatitis severity', 'radiation dermatitis', 'toxicity scorings', 'hyperpigmentation', 'pain', 'rates and severity of acute radiation-induced skin toxicity', 'Objective photospectrometric measurements', 'erythema severity']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457102', 'cui_str': 'Whole breast (qualifier value)'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}]","[{'cui': 'C0037805', 'cui_str': 'Spectrophotometry'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}, {'cui': 'C0457102', 'cui_str': 'Whole breast (qualifier value)'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}]","[{'cui': 'C0034561', 'cui_str': 'Radiation-Induced Dermatitis'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0162834', 'cui_str': 'Hypermelanosis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}]",140.0,0.0741957,"Patients allocated to hypofractionated WBI also reported less pain (p = .006), less hyperpigmentation (p = <0.001) and less limitations of day-to-day activities (p = <0.001). ","[{'ForeName': 'Leonard Christopher', 'Initials': 'LC', 'LastName': 'Schmeel', 'Affiliation': 'Department of Radiation Oncology, University Hospital Bonn, University of Bonn, Germany. Electronic address: christopher.schmeel@ukbonn.de.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Koch', 'Affiliation': 'Department of Radiation Oncology, University Hospital Bonn, University of Bonn, Germany.'}, {'ForeName': 'Frederic Carsten', 'Initials': 'FC', 'LastName': 'Schmeel', 'Affiliation': 'Department of Radiology, University Hospital Bonn, University of Bonn, Germany.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Röhner', 'Affiliation': 'Department of Radiation Oncology, University Hospital Bonn, University of Bonn, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Schoroth', 'Affiliation': 'Department of Radiation Oncology, University Hospital Bonn, University of Bonn, Germany.'}, {'ForeName': 'Bettina Maja', 'Initials': 'BM', 'LastName': 'Bücheler', 'Affiliation': 'Department of Radiation Oncology, University Hospital Bonn, University of Bonn, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Mahlmann', 'Affiliation': 'Radiotherapy Bonn-Rhein-Sieg, Practice at Academic St. Marien Hospital, Bonn, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Leitzen', 'Affiliation': 'Department of Radiation Oncology, University Hospital Bonn, University of Bonn, Germany.'}, {'ForeName': 'Heinrich', 'Initials': 'H', 'LastName': 'Schüller', 'Affiliation': 'Department of Radiation Oncology, University Hospital Bonn, University of Bonn, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Tschirner', 'Affiliation': 'Department of Radiation Oncology, University Hospital Bonn, University of Bonn, Germany.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Fuhrmann', 'Affiliation': 'Department of Radiation Oncology, University Hospital Bonn, University of Bonn, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Heimann', 'Affiliation': 'Department of Radiation Oncology, University Hospital Bonn, University of Bonn, Germany.'}, {'ForeName': 'Dilini', 'Initials': 'D', 'LastName': 'Brüser', 'Affiliation': 'Department of Radiation Oncology, University Hospital Bonn, University of Bonn, Germany.'}, {'ForeName': 'Alina-Valik', 'Initials': 'AV', 'LastName': 'Abramian', 'Affiliation': 'Department of Gynecology and Obstetrics, Division of Senology, University Hospital Bonn, University of Bonn, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Müdder', 'Affiliation': 'Department of Radiation Oncology, University Hospital Bonn, University of Bonn, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Garbe', 'Affiliation': 'Department of Radiation Oncology, University Hospital Bonn, University of Bonn, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Vornholt', 'Affiliation': 'Department of Radiation Oncology, Agaplesion General Hospital, Academic Hospital of the University of Bochum, Hagen, Germany.'}, {'ForeName': 'Hans Heinz', 'Initials': 'HH', 'LastName': 'Schild', 'Affiliation': 'Department of Radiation Oncology, University Hospital Bonn, University of Bonn, Germany; Department of Radiology, University Hospital Bonn, University of Bonn, Germany.'}, {'ForeName': 'Brigitta Gertrud', 'Initials': 'BG', 'LastName': 'Baumert', 'Affiliation': 'Institute of Radiation Oncology, Graubuenden Cantonal Hospital, Chur, Switzerland.'}, {'ForeName': 'Timo Martin', 'Initials': 'TM', 'LastName': 'Wilhelm-Buchstab', 'Affiliation': 'Department of Radiation Oncology, University Hospital Bonn, University of Bonn, Germany.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.02.018'] 179,32146259,Prostate high dose-rate brachytherapy as monotherapy for low and intermediate risk prostate cancer: Efficacy results from a randomized phase II clinical trial of one fraction of 19 Gy or two fractions of 13.5 Gy.,"BACKGROUND AND PURPOSE High dose-rate (HDR) brachytherapy as monotherapy is a treatment option for localized prostate cancer, but optimal dose and fractionation is unknown. We report efficacy results of a randomized phase II trial of HDR monotherapy delivered as either one or two fractions. MATERIALS AND METHODS Eligible patients had low or intermediate risk prostate cancer, prostate volume <60 cc, and no androgen deprivation use. 170 patients were randomized to receive HDR as either a single fraction of 19 Gy or as two fractions of 13.5 Gy one week apart. Median age was 65 years, median PSA was 6.33 ng/ml, and Grade Group 1, 2 and 3 was present in 28%, 60%, and 12%, respectively. There was no difference in baseline factors between arms and 19%, 51% and 30% had low risk, favourable intermediate and unfavourable intermediate risk disease, respectively. The Phoenix definition was used to define biochemical failure, all local failures were confirmed by biopsy and toxicity was assessed using CTCAE v.4. RESULTS Median follow-up was 60 months. PSA decreased more quickly in the 2-fraction arm (p = 0.009). Median PSA at 5-years was 0.65 ng/ml in the single fraction and 0.16 ng/ml in the 2-fraction arm. The 5-year biochemical disease-free survival and cumulative incidence of local failure was 73.5% and 29% in the single fraction arm and 95% (p = 0.001) and 3% (p < 0.001) in the 2-fraction arm, respectively. Recurrence was not associated with initial stage, grade group, or risk group. Grade 2 late rectal toxicity occurred in 1% while the incidence of grade 2 and 3 urinary toxicity was 45% and 1%, respectively, with no difference between arms. CONCLUSIONS HDR monotherapy delivered as two fraction of 13.5 Gy is well tolerated with a high cancer control rate at 5 years. Single fraction monotherapy is inferior and should not be used.",2020,"The 5-year biochemical disease-free survival and cumulative incidence of local failure was 73.5% and 29% in the single fraction arm and 95% (p = 0.001) and 3% (p < 0.001) in the 2-fraction arm, respectively.","['170 patients', 'low and intermediate risk prostate cancer', 'Eligible patients had low or intermediate risk prostate cancer, prostate volume']","['HDR', 'HDR monotherapy', 'rate (HDR) brachytherapy', 'Prostate high dose-rate brachytherapy as monotherapy']","['PSA', 'Recurrence', 'urinary toxicity', '5-year biochemical disease-free survival and cumulative incidence of local failure', 'baseline factors', 'Grade 2 late rectal toxicity', 'median PSA', 'Median PSA']","[{'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]","[{'cui': 'C0006098', 'cui_str': 'Radioisotope Brachytherapy'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0454270', 'cui_str': 'High dose rate brachytherapy (observable entity)'}]","[{'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",170.0,0.117532,"The 5-year biochemical disease-free survival and cumulative incidence of local failure was 73.5% and 29% in the single fraction arm and 95% (p = 0.001) and 3% (p < 0.001) in the 2-fraction arm, respectively.","[{'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Morton', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Canada. Electronic address: gerard.morton@sunnybrook.ca.'}, {'ForeName': 'Merrylee', 'Initials': 'M', 'LastName': 'McGuffin', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Canada.'}, {'ForeName': 'Hans T', 'Initials': 'HT', 'LastName': 'Chung', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Canada.'}, {'ForeName': 'Chia-Lin', 'Initials': 'CL', 'LastName': 'Tseng', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Canada.'}, {'ForeName': 'Joelle', 'Initials': 'J', 'LastName': 'Helou', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Canada.'}, {'ForeName': 'Ananth', 'Initials': 'A', 'LastName': 'Ravi', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Cheung', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Canada.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Szumacher', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Canada.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Canada.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Chu', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Canada.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Canada.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Mamedov', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Loblaw', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Canada.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.02.009'] 180,32006325,"Safety, Tolerability and Pharmacokinetics of Single Dose Polyethylene Glycolated Exenatide Injection (PB-119) in Healthy Volunteers.","BACKGROUND AND OBJECTIVE Exenatide promotes insulin secretion and inhibits postprandial glucagon secretion. Polyethylene glycolated exenatide injection (PB-119), a derivative obtained by modification of exenatide, is more stable in metabolic behavior than exenatide in vivo. Our study aimed to evaluate the safety, tolerability and pharmacokinetic characteristics of polyethylene glycolated exenatide as a single subcutaneous injection in healthy volunteers. METHODS Seventy subjects were randomly assigned to 8 incremental dosage groups (2, 5, 10, 25, 50, 100, 200 and 400 µg). The 2- to 50-µg groups had 8 subjects in each group (the ratio of test preparation to placebo was 3:1), and the 100- to 400-µg groups had 10 subjects in each group (the ratio of test preparation to placebo was 4:1). All the subjects received a single subcutaneous injection of polyethylene glycolated exenatide and placebo according to the dosage groups. The tolerability test was conducted in the 2- to 10-µg groups. The pharmacokinetic test was carried out in the 25- to 400-µg groups, and plasma samples were collected to determine the pharmacokinetics of polyethylene glycolated exenatide. After medication, the vital signs of the subjects were monitored, and laboratory tests and electrocardiogram tests were carried out regularly in all the subjects. RESULTS All 70 subjects completed the experiment. Except for the 5-µg and 10-µg groups, the safety and tolerability tests showed no adverse reactions in the 2-µg to 50-µg groups. Several subjects in the 100-µg and 200-µg groups had tolerable gastrointestinal tract reactions, and all subjects in the 400-µg group experienced adverse reactions, mainly gastrointestinal tract reactions and liver dysfunction. The pharmacokinetics of polyethylene glycolated exenatide was studied in 36 subjects, which showed slow absorption, a mean peak time of 20-40 h, and a mean elimination half-life of 51-64 h. CONCLUSION The administration of polyethylene glycolated exenatide injection at a single dose of 2-200 µg is safe and tolerable for healthy volunteers. Once-weekly polyethylene glycolated exenatide injection can be recommended. CLINICAL TRIALS REGISTRATION The study was registered at clinicaltrials.gov (No. NCT02084251).",2020,"Except for the 5-µg and 10-µg groups, the safety and tolerability tests showed no adverse reactions in the 2-µg to 50-µg groups.","['healthy volunteers', 'Seventy subjects', '36 subjects, which showed slow absorption, a mean peak time of 20-40\xa0h, and a mean elimination half-life of 51-64\xa0h.\nCONCLUSION', 'Healthy Volunteers', 'All 70 subjects completed the experiment']","['Polyethylene glycolated exenatide injection (PB-119', 'Single Dose Polyethylene', 'polyethylene glycolated exenatide', 'polyethylene glycolated exenatide injection', 'placebo', 'Glycolated Exenatide Injection (PB-119', 'polyethylene glycolated exenatide and placebo']","['Safety, Tolerability and Pharmacokinetics', 'tolerability test', 'safety and tolerability tests', 'adverse reactions, mainly gastrointestinal tract reactions and liver dysfunction', 'tolerable gastrointestinal tract reactions', 'adverse reactions']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0137914', 'cui_str': 'Polythene'}, {'cui': 'C0220840', 'cui_str': 'glycolate'}, {'cui': 'C4026823', 'cui_str': 'exenatide Injection [Bydureon]'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal Tract'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0086565', 'cui_str': 'Liver Dysfunction'}]",70.0,0.0344652,"Except for the 5-µg and 10-µg groups, the safety and tolerability tests showed no adverse reactions in the 2-µg to 50-µg groups.","[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Cui', 'Affiliation': 'Institute of Clinical Pharmacology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Cai-Yun', 'Initials': 'CY', 'LastName': 'Zhao', 'Affiliation': 'Institute of Clinical Pharmacology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Lv', 'Affiliation': 'Institute of Clinical Pharmacology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China. LY52850@163.com.'}, {'ForeName': 'Min-Ji', 'Initials': 'MJ', 'LastName': 'Wei', 'Affiliation': 'Institute of Clinical Pharmacology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Institute of Clinical Pharmacology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Institute of Clinical Pharmacology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Ya-Hong', 'Initials': 'YH', 'LastName': 'Xia', 'Affiliation': 'Institute of Clinical Pharmacology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Institute of Clinical Pharmacology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Ji-Hong', 'Initials': 'JH', 'LastName': 'Tian', 'Affiliation': 'Institute of Clinical Pharmacology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Pu', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Institute of Clinical Pharmacology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}]",European journal of drug metabolism and pharmacokinetics,['10.1007/s13318-020-00605-9'] 181,32240463,Neurological and behavioral features of locomotor imagery in the blind.,"In people with normal sight, mental simulation (motor imagery) of an experienced action involves a multisensory (especially kinesthetic and visual) emulation process associated with the action. Here, we examined how long-term blindness influences sensory experience during motor imagery and its neuronal correlates by comparing data obtained from blind and sighted people. We scanned brain activity with functional magnetic resonance imaging (fMRI) while 16 sighted and 14 blind male volunteers imagined either walking or jogging around a circle of 2 m radius. In the training before fMRI, they performed these actions with their eyes closed. During scanning, we explicitly instructed the blindfolded participants to generate kinesthetic motor imagery. After the experimental run, they rated the degree to which their motor imagery became kinesthetic or spatio-visual. The imagery of blind people was more kinesthetic as per instructions, while that of the sighted group became more spatio-visual. The imagery of both groups commonly activated bilateral frontoparietal cortices including supplementary motor areas (SMA). Despite the lack of group differences in degree of brain activation, we observed stronger functional connectivity between the SMA and cerebellum in the blind group compared to that in the sighted group. To conclude, long-term blindness likely changes sensory emulation during motor imagery to a more kinesthetic mode, which may be associated with stronger functional coupling in kinesthetic brain networks compared with that in sighted people. This study adds valuable knowledge on motor cognition and mental imagery processes in the blind.",2021,The imagery of both groups commonly activated bilateral frontoparietal cortices including supplementary motor areas (SMA).,['16 sighted and 14 blind male volunteers imagined either walking or jogging around a circle of 2\xa0m radius'],['functional magnetic resonance imaging (fMRI'],"['spatio-visual', 'degree of brain activation', 'motor cognition and mental imagery processes']","[{'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0022400', 'cui_str': 'Jogging'}, {'cui': 'C0231706', 'cui_str': 'Circling gait'}, {'cui': 'C0034627', 'cui_str': 'Bone structure of radius'}]","[{'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C1522240', 'cui_str': 'Process'}]",,0.0784787,The imagery of both groups commonly activated bilateral frontoparietal cortices including supplementary motor areas (SMA).,"[{'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Amemiya', 'Affiliation': 'Center for Information and Neural Networks (CiNet), National Institute of Information and Communications Technology (NICT), 1-4 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Tomoyo', 'Initials': 'T', 'LastName': 'Morita', 'Affiliation': 'Center for Information and Neural Networks (CiNet), National Institute of Information and Communications Technology (NICT), 1-4 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Hirose', 'Affiliation': 'Center for Information and Neural Networks (CiNet), National Institute of Information and Communications Technology (NICT), 1-4 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Ikegami', 'Affiliation': 'Center for Information and Neural Networks (CiNet), National Institute of Information and Communications Technology (NICT), 1-4 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Hirashima', 'Affiliation': 'Center for Information and Neural Networks (CiNet), National Institute of Information and Communications Technology (NICT), 1-4 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Naito', 'Affiliation': 'Center for Information and Neural Networks (CiNet), National Institute of Information and Communications Technology (NICT), 1-4 Yamadaoka, Suita, Osaka, 565-0871, Japan. eiichi.naito@nict.go.jp.'}]",Brain imaging and behavior,['10.1007/s11682-020-00275-w'] 182,31882381,Intraoperative Optimization of Both Depth of Anesthesia and Cerebral Oxygenation in Elderly Patients Undergoing Coronary Artery Bypass Graft Surgery-A Randomized Controlled Pilot Trial.,"OBJECTIVES Does intraoperative optimization of both depth of anesthesia and regional cerebral tissue oxygenation (rScO 2 ) in elderly patients reduce postoperative cognitive decline (primary outcome) or delirium (secondary outcome)? DESIGN Prospective randomized controlled single blind trial. SETTING A single major urban teaching and university hospital and tertiary referral center. PARTICIPANTS Patients, 65 years of age and older, undergoing elective coronary artery bypass graft surgery on cardiopulmonary bypass. INTERVENTIONS Intraoperative depth of anesthesia bispectral index (BIS) values were targeted at 50 ± 10. Regional cerebral tissue desaturations of more than 15% of the pre-induction value, or below 50%, were avoided. MEASUREMENTS AND MAIN RESULTS Eighty-two patients were included, and mean depth of anesthesia values using BIS were significantly higher during surgery in the intervention group with 40.6 (7.3) versus 35.4 (6.7) in the control group, mean (standard deviation), p = 0.004. The cognitive function was similar between the treatment and control groups at 6 weeks postoperatively with a Mini Mental State Examination (MMSE) of 27 (26,29) in the intervention group and an MMSE of 29 (27,29) in the control group, median (interquartile range), with p = 0.12. The authors observed a reduction in the incidence of delirium, occurring in 2.4% (n = 1) of patients in the intervention group and in 20% (n = 8) in the control group (p = 0.01). CONCLUSIONS This pilot trial demonstrates that noninvasive target-controlled depth of anesthesia monitoring is feasible. Cognitive function at 6 weeks showed no difference between the treatment and control groups; however, postoperative delirium was reduced in the intervention group.",2020,"The cognitive function was similar between the treatment and control groups at 6 weeks postoperatively with a Mini Mental State Examination (MMSE) of 27 (26,29) in the intervention group and an MMSE of 29 (27,29) in the control group, median (interquartile range), with p = 0.12.","['Patients, 65 years of age and older, undergoing elective coronary artery bypass graft surgery on cardiopulmonary bypass', 'Elderly Patients Undergoing', 'A single major urban teaching and university hospital and tertiary referral center', 'elderly patients reduce postoperative cognitive decline (primary outcome) or delirium (secondary outcome']","['Intraoperative Optimization of Both Depth of Anesthesia and Cerebral Oxygenation', 'Coronary Artery Bypass Graft Surgery', 'anesthesia and regional cerebral tissue oxygenation (rScO 2 ']","['Cognitive function', 'Regional cerebral tissue desaturations', 'incidence of delirium', 'cognitive function', 'mean depth of anesthesia values using BIS', 'postoperative delirium']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0234985', 'cui_str': 'Cognitive Decline'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0474710', 'cui_str': 'Depth of anesthesia (observable entity)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0474710', 'cui_str': 'Depth of anesthesia (observable entity)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}, {'cui': 'C1319200', 'cui_str': 'Postoperative confusion'}]",82.0,0.152321,"The cognitive function was similar between the treatment and control groups at 6 weeks postoperatively with a Mini Mental State Examination (MMSE) of 27 (26,29) in the intervention group and an MMSE of 29 (27,29) in the control group, median (interquartile range), with p = 0.12.","[{'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Kunst', 'Affiliation': ""Department of Anaesthetics and Pain Medicine, King's College Hospital NHS Foundation Trust, London, United Kingdom; School of Cardiovascular Medicine and Sciences, King's College London British Heart Foundation Centre of Excellence, Faculty of Life Sciences and Medicine, London, United Kingdom. Electronic address: gudrun.kunst@kcl.ac.uk.""}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Gauge', 'Affiliation': 'Wolfson Centre for Age-Related Diseases, Institute of Psychiatry, Psychology and Neuroscience, Kings College London, London, United Kingdom.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Salaunkey', 'Affiliation': ""Department of Anaesthetics and Pain Medicine, King's College Hospital NHS Foundation Trust, London, United Kingdom; Royal Papworth Hospital, Cambridge, United Kingdom.""}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Spazzapan', 'Affiliation': ""School of Cardiovascular Medicine and Sciences, King's College London British Heart Foundation Centre of Excellence, Faculty of Life Sciences and Medicine, London, United Kingdom.""}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Amoako', 'Affiliation': ""Department of Anaesthetics and Pain Medicine, King's College Hospital NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Ferreira', 'Affiliation': ""Department of Anaesthetics and Pain Medicine, King's College Hospital NHS Foundation Trust, London, United Kingdom; Wolfson Centre for Age-Related Diseases, Institute of Psychiatry, Psychology and Neuroscience, Kings College London, London, United Kingdom.""}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Green', 'Affiliation': ""Department of Anaesthetics and Pain Medicine, King's College Hospital NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Ballard', 'Affiliation': 'University of Exeter Medical School, Exeter, United Kingdom; Wolfson Centre for Age-Related Diseases, Institute of Psychiatry, Psychology and Neuroscience, Kings College London, London, United Kingdom.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2019.10.054'] 183,32236442,Exercising before a nap benefits memory better than napping or exercising alone.,"Sleep leads to the enhancement of memory, and physical exercise also improves memory along with beneficial effects on sleep quality. Potentially, sleep and exercise may operate independently upon memory; alternatively, they may operate synergistically to boost memory above and beyond exercise or sleep alone. We tested this hypothesis in 115 young healthy adults (23 ± 3.9 years) randomly allocated to one of the four conditions in a 2 (exercise vs. no exercise) × 2 (nap vs. no nap) design. The exercise intervention consisted of a 40-minute, moderate intensity cycling, while the no exercise condition was an equivalent period of rest. This was followed by a learning session in which participants memorized a set of 45 neutral pictures for a later test. Subsequently, participants were exposed to either a 60-minute sleep period (nap) or an equivalent time of resting wakefulness, followed by a visual recognition test. We found a significant interaction between the effects of exercise and nap (p = 0.014, η p2 = 0.053), without significant main effects of exercise or nap conditions. Participants who experienced both exercise plus nap were significantly more accurate (83.8 ± 2.9) than those who only napped (81.1 ± 5.4, p = 0.027) and those who only exercised (78.6 ± 10.3, p = 0.012). Within the combined nap plus exercise group, higher recognition accuracies were associated with higher sleep spindle densities (r = 0.46, p = 0.015). Our results demonstrate that short-term exercise and a nap improve recognition memory over a nap or exercise alone. Exercise and sleep are not independent factors operating separately upon memory but work together to enhance long-term memory.",2020,"Participants who experienced both exercise plus nap were significantly more accurate (83.8±2.9) than those who only napped (81.1±5.4, p=0.027) and those who only exercised (78.6±10.3, p=0.012).",['115 young healthy adults (23±3.9 years'],"['60-min sleep period (nap) or an equivalent time of resting wakefulness, followed by a visual recognition test', 'exercise intervention consisted of a 40-min, moderate-intensity cycling, while the no exercise condition', 'napping or exercising alone', '2 (exercise vs no exercise']","['recognition memory', 'sleep spindle densities', 'higher recognition accuracies', 'sleep quality']","[{'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0067518', 'cui_str': 'N-(4-aminophenethyl)spiroperidol'}]","[{'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",115.0,0.0475359,"Participants who experienced both exercise plus nap were significantly more accurate (83.8±2.9) than those who only napped (81.1±5.4, p=0.027) and those who only exercised (78.6±10.3, p=0.012).","[{'ForeName': 'Melodee', 'Initials': 'M', 'LastName': 'Mograss', 'Affiliation': 'Department of Health, Kinesiology and Applied Physiology, Concordia University, Montreal, QC, Canada.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Crosetta', 'Affiliation': 'Department of Psychology, Concordia University, Montreal, QC, Canada.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Abi-Jaoude', 'Affiliation': 'Department of Psychology, Concordia University, Montreal, QC, Canada.'}, {'ForeName': 'Elizaveta', 'Initials': 'E', 'LastName': 'Frolova', 'Affiliation': 'Department of Psychology, Concordia University, Montreal, QC, Canada.'}, {'ForeName': 'Edwin M', 'Initials': 'EM', 'LastName': 'Robertson', 'Affiliation': 'Institute of Neuroscience & Psychology, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Pepin', 'Affiliation': 'Department of Health, Kinesiology and Applied Physiology, Concordia University, Montreal, QC, Canada.'}, {'ForeName': 'Thien Thanh', 'Initials': 'TT', 'LastName': 'Dang-Vu', 'Affiliation': 'Department of Health, Kinesiology and Applied Physiology, Concordia University, Montreal, QC, Canada.'}]",Sleep,['10.1093/sleep/zsaa062'] 184,32239161,Role of persistent and worsening sleep disturbance in depression remission and suicidal ideation among older primary care patients: the PROSPECT study.,"STUDY OBJECTIVES We analyzed data from a practice-based randomized controlled trial within 20 primary care practices located in greater New York City, Philadelphia, and Pittsburgh to determine whether persistent or worsening sleep disturbance plays a role in the outcomes of depression and suicidal ideation at 1 year in older adults with depression. METHODS The study sample consisted of 599 adults aged 60 years and older meeting criteria for major depression or clinically significant minor depression. Longitudinal analysis via growth curve mixture modeling was carried out to classify patients as having worsening, persistent, or improving sleep over 1 year. RESULTS At 1-year follow-up, compared with patients with improving sleep, those with worsening sleep were more likely to have a diagnosis of major depression (adjusted odds ratio (aOR) = 28.60, 95% confidence interval (CI) 12.15 to 67.34), a diagnosis of clinically significant minor depression (aOR = 11.88, 95% CI 5.67 to 24.89), and suicidal ideation (aOR = 1.10, 1.005 to 1.199), and were half as likely to achieve remission (aOR = 0.52, 95% CI 0.46 to 0.57). Patients with persistent sleep disturbance showed similar but attenuated results. CONCLUSIONS Older primary care patients with depression who exhibit worsening or persistent sleep disturbance were at increased risk for persistent depression and suicidal ideation 1 year later. The pattern of sleep disturbance over time may be an important signal for exploration by primary care physicians of depression and suicidal ideation among older adults with depression. CLINICAL TRIAL REGISTRATION NCT00279682.",2020,"Patients with persistent sleep disturbance showed similar but attenuated results. ","['older adults with depression', '599 adults aged 60 years and older meeting criteria for major depression or clinically significant minor depression', 'Older Primary Care Patients', '20 primary care practices located in greater New York City, Philadelphia, and Pittsburgh to determine whether persistent or worsening sleep disturbance', 'Older primary care patients with depression who exhibit worsening or persistent sleep disturbance']",[],"['diagnosis of major depression', 'suicidal ideation']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}]",[],"[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}]",599.0,0.0662918,"Patients with persistent sleep disturbance showed similar but attenuated results. ","[{'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Gallo', 'Affiliation': 'Department of Mental Health, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Seungyoung', 'Initials': 'S', 'LastName': 'Hwang', 'Affiliation': 'Department of Health Policy and Management, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Truong', 'Affiliation': 'Department of Mental Health, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Charles F', 'Initials': 'CF', 'LastName': 'Reynolds', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Spira', 'Affiliation': 'Department of Mental Health, Johns Hopkins University, Baltimore, MD.'}]",Sleep,['10.1093/sleep/zsaa063'] 185,32237005,A behavioral economics-based telehealth intervention to improve aspirin adherence following hospitalization for acute coronary syndrome.,"PURPOSE A significant number of patients with acute coronary syndrome (ACS) are nonadherent to aspirin after hospital discharge, with an associated increased risk of subsequent cardiovascular events. The purpose of this pilot study was to test the efficacy of a telehealth intervention based on behavioral economics to improve aspirin adherence following hospitalization for ACS. METHODS We enrolled 130 participants (c¯X = 58 ± 10.7 years of age, 38% female, 45% black) from two hospitals. Patients were eligible if they owned a smartphone and were admitted to the hospital for ACS, prescribed aspirin at discharge, and responsible for administering their own medications. Consenting participants were randomized to the intervention or usual care group. The intervention group was eligible to receive up to $50 per month if they took their medicine daily, with $2 per day deducted if a dose was missed. All participants received an electronic monitoring (EM) pill bottle containing a 90-day supply of aspirin, which was used to measure adherence calculated as the proportion of prescribed drug taken using the EM device. Based on the skewness in the adherence distribution, quantile regression was used to evaluate the effect of the intervention on median adherence over time. RESULTS After 90 days, adherence fell in the control group but remained high in the intervention group (median adherence 81% vs 90%, P = .18). Rehospitalization was higher in the control group (24% vs 13%, P = .17). CONCLUSION A loss aversion behavioral economics-based telehealth intervention is a promising approach to improving aspirin adherence following hospitalization for ACS.",2020,"Rehospitalization was higher in the control group (24% vs 13%, P = .17). ","['acute coronary syndrome', 'Patients were eligible if they owned a smartphone and were admitted to the hospital for ACS, prescribed aspirin at discharge, and responsible for administering their own medications', 'patients with acute coronary syndrome (ACS', '130 participants (c¯X = 58\u2009±\u200910.7\u2009years of age, 38% female, 45% black) from two hospitals', 'Consenting participants']","['aspirin', 'intervention or usual care group', 'behavioral economics-based telehealth intervention', 'electronic monitoring (EM) pill bottle containing a 90-day supply of aspirin', 'telehealth intervention']","['Rehospitalization', 'aspirin adherence', 'median adherence over time', 'adherence fell']","[{'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0002455', 'cui_str': 'American Cancer Society'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C5191365', 'cui_str': '10.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0336646', 'cui_str': 'Electronic monitor'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0179376', 'cui_str': 'Bottle'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",130.0,0.040123,"Rehospitalization was higher in the control group (24% vs 13%, P = .17). ","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Riegel', 'Affiliation': 'School of Nursing at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Alisa', 'Initials': 'A', 'LastName': 'Stephens-Shields', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Jaskowiak-Barr', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Daus', 'Affiliation': 'School of Nursing at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Kimmel', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.'}]",Pharmacoepidemiology and drug safety,['10.1002/pds.4988'] 186,32234275,"Does Telehealth Delivery of a Dyadic Dementia Care Program Provide a Noninferior Alternative to Face-To-Face Delivery of the Same Program? A Randomized, Controlled Trial.","OBJECTIVE This study aimed to determine whether delivery of a dyadic intervention using telehealth was noninferior to delivery of the same program using traditional face-to-face delivery through home visits. DESIGN We conducted a noninferiority randomized controlled trial. PARTICIPANTS Participants had a diagnosis of dementia, were living in the community, and had an informal caregiver who reported difficulties in managing activities of daily living or behavioral symptoms. INTERVENTION Participants were randomized to receive either telehealth or home visit delivery of the same intervention program. MEASUREMENTS The primary outcome was the Caregiving Mastery Index, secondary outcomes included caregiver's perceptions of change, activities of daily living function, and type and frequency of behavioral symptoms of persons living with dementia. Therapists delivering the intervention recorded the time spent delivering the intervention as well as travel time. RESULTS Sixty-three dyads were recruited and randomized. Both groups reported improvements for the primary outcome, however, these were not statistically significant. There were no significant differences between groups for the primary outcome (mean difference 0.09 (95% confidence interval -1.26 to 1.45) or the secondary outcomes at 4 months. Both groups reported significant improvements in caregiver's perceptions of change. The amount of time spent delivering the content of the program was similar between groups, however offering the intervention via telehealth significantly reduced travel time (mean 255.9 minutes versus mean 77.2 minutes, p <0.0001). CONCLUSION It is feasible to offer dyadic interventions via telehealth and doing so reduces travel time and results in similar benefits for families.",2020,"The amount of time spent delivering the content of the program was similar between groups, however offering the intervention via telehealth significantly reduced travel time (mean 255.9 minutes versus mean 77.2 minutes, p <0.0001). ","['Participants had a diagnosis of dementia, were living in the community, and had an informal caregiver who reported difficulties in managing activities of daily living or behavioral symptoms', 'Sixty-three dyads were recruited and randomized']",['telehealth or home visit delivery of the same intervention program'],"['travel time', ""Caregiving Mastery Index, secondary outcomes included caregiver's perceptions of change, activities of daily living function, and type and frequency of behavioral symptoms of persons living with dementia""]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C1269688', 'cui_str': 'Activities of daily living management'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0040802', 'cui_str': 'Travel'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}]",63.0,0.213133,"The amount of time spent delivering the content of the program was similar between groups, however offering the intervention via telehealth significantly reduced travel time (mean 255.9 minutes versus mean 77.2 minutes, p <0.0001). ","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Laver', 'Affiliation': 'College of Medicine and Public Health (KL, EL, OD, MC), Flinders University, Adelaide, South Australia, Australia. Electronic address: Kate.Laver@flinders.edu.au.'}, {'ForeName': 'Enwu', 'Initials': 'E', 'LastName': 'Liu', 'Affiliation': 'College of Medicine and Public Health (KL, EL, OD, MC), Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Lindy', 'Initials': 'L', 'LastName': 'Clemson', 'Affiliation': 'University of Sydney (LC), Sydney, New South Wales, Australia.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Davies', 'Affiliation': 'College of Medicine and Public Health (KL, EL, OD, MC), Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Len', 'Initials': 'L', 'LastName': 'Gray', 'Affiliation': 'University of Queensland (LG), Queensland, Australia.'}, {'ForeName': 'Laura N', 'Initials': 'LN', 'LastName': 'Gitlin', 'Affiliation': 'Drexel University (LNG), Philadelphia, PA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Crotty', 'Affiliation': 'College of Medicine and Public Health (KL, EL, OD, MC), Flinders University, Adelaide, South Australia, Australia.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.02.009'] 187,32248227,Electrical Stimulation Therapies for Active Duty Military with Patellofemoral Pain Syndrome: A Randomized Trial.,"INTRODUCTION Patellofemoral pain syndrome (PFPS) is a common musculoskeletal disorder among military service members that causes knee pain, quadriceps strength loss, and impaired motor performance in otherwise healthy individuals. PFPS poses a threat to the health, fitness, and subsequent readiness of the total force. The goal of rehabilitation for military service members with PFPS is to regain physical capacity of strength and function and to reduce pain, in order to restore readiness in this population. The randomized controlled trial reported here compared an active home exercise program (HEP) alone with three different electrical stimulation treatment regimens implemented concurrently with HEP postulated improvements in lower extremity strength and physical functional performance while also reducing pain in active duty military diagnosed with PFPS. MATERIALS AND METHODS After baseline testing, 130 active duty military members with PFPS were randomized to 1 of 4 treatment groups: (1) neuromuscular electrical stimulation (NMES) with HEP; (2) transcutaneous electrical nerve stimulation (TENS) with HEP; (3) combined NMES/TENS with HEP; (4) active HEP only. The primary outcome measure was degree of change in knee flexion and extension strength over 9 weeks. Secondary outcomes were physical functional performance and knee pain. The primary analyses used repeated measures, linear mixed-effects models with a random effect for subject, time as a continuous variable, group as a categorical variable, and a group and time interaction to test for differences in change over time among the groups. RESULTS All three electrical stimulation treatment groups improved in knee extension strength in the PFPS limb to a greater extent than the HEP alone group over the 9-week treatment period. The NMES and NMES/TENS groups improved to a greater extent than the HEP alone group in knee flexion strength in the PFPS limb. The reported pain improved over time for all treatment groups with no significant group differences. All three stimulation groups performed better on the 6-min walk test than the HEP alone group. CONCLUSION The findings from this study showed that all three electrical stimulation with HEP treatment groups showed greater improvement in strength compared to the HEP alone group. These findings could offer alternative forms of rehabilitation for AD military with PFPS as these treatment regimens can be easily implemented at home station or during deployment.",2020,The NMES and NMES/TENS groups improved to a greater extent than the HEP alone group in knee flexion strength in the PFPS limb.,"['otherwise healthy individuals', 'Active Duty Military with Patellofemoral Pain Syndrome', 'military service members with', 'active duty military diagnosed with PFPS', '130 active duty military members with PFPS']","['active home exercise program (HEP', 'Electrical Stimulation Therapies', 'neuromuscular electrical stimulation (NMES) with HEP; (2) transcutaneous electrical nerve stimulation (TENS) with HEP; (3) combined NMES/TENS with HEP; (4) active HEP only', 'HEP', 'PFPS']","['physical functional performance and knee pain', 'knee flexion strength', 'pain', 'knee extension strength', 'lower extremity strength and physical functional performance', 'strength', 'degree of change in knee flexion and extension strength']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3831794', 'cui_str': 'Active duty military'}, {'cui': 'C0877149', 'cui_str': 'Patellofemoral pain syndrome'}, {'cui': 'C0336524', 'cui_str': 'Military services member'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0680022', 'cui_str': 'Member of'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}, {'cui': 'C0162569', 'cui_str': 'Homozygous porphyria cutanea tarda'}, {'cui': 'C0013787', 'cui_str': 'Electrotherapy'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0014518', 'cui_str': 'Lyell syndrome'}]","[{'cui': 'C4704690', 'cui_str': 'Physical Functional Performance'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",130.0,0.0562604,The NMES and NMES/TENS groups improved to a greater extent than the HEP alone group in knee flexion strength in the PFPS limb.,"[{'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Talbot', 'Affiliation': 'Department of Neurology, College of Medicine, University of Tennessee Health Science Center, 855 Monroe Ave, Suite 415, Memphis, TN 38163.'}, {'ForeName': 'Zack', 'Initials': 'Z', 'LastName': 'Solomon', 'Affiliation': 'Physical Therapy Services, Dunham U.S. Army Health Clinic, Carlisle Barracks, PA 17013.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Webb', 'Affiliation': 'Byrd Clinic Physical Therapy, Fort Campbell, KY 42240.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Morrell', 'Affiliation': 'Department of Mathematics and Statistics, Loyola University Maryland, Baltimore, MD 21210-2699.'}, {'ForeName': 'E Jeffrey', 'Initials': 'EJ', 'LastName': 'Metter', 'Affiliation': 'Department of Neurology, College of Medicine, University of Tennessee Health Science Center, 855 Monroe Ave, Suite 415, Memphis, TN 38163.'}]",Military medicine,['10.1093/milmed/usaa037'] 188,31633789,Opioid Exposure Negatively Affects Antidepressant Response to Venlafaxine in Older Adults with Chronic Low Back Pain and Depression.,"OBJECTIVE Serotonin norepinephrine reuptake inhibitors (SNRIs) are commonly co-prescribed with opioids for chronic pain. The purpose of this study was to describe pain and mood response to venlafaxine among older adults with chronic low back pain (CLBP) and depression relative to opioid exposure. DESIGN Secondary analyses were collected from a randomized clinical trial testing a stepped-care approach to comorbid pain and depression in older patients: the Addressing Depression and Pain Together study (ADAPT: 2010-2016). SETTING University-based late-life mental health research clinic. SUBJECTS Two hundred twenty-seven adults aged 65+ years with CLBP and depression. METHODS Participants received six weeks of lower-dose venlafaxine (≤150 mg/d). Pain and depression were measured each week. Response for both pain and depression at the end of six weeks was defined by a ≥30% improvement on a 0-20 numeric rating scale for low back pain and a Patient Health Questionnaire-9 score ≤5. Opioid exposure was analyzed as prescribed (yes or no) and by morphine equivalent dosing (MED). RESULTS Patients co-prescribed an opioid were less likely to report a pain response to venlafaxine. MED was negatively correlated with pain response. Depression response was not impacted. CONCLUSIONS Opioids are negatively associated with older adults' early analgesic response to lower-dose venlafaxine. These findings suggest that clinicians may wish to consider either nonopioid or alternative antidepressant approaches to pain management in these complex patients. It is reassuring that opioids do not prevent depression response. Future research should examine both longer duration of treatment and a wider range of doses.",2020,"Depression response was not impacted. ","['Two hundred twenty-seven adults aged 65+ years with CLBP and depression', 'Older Adults with Chronic Low Back Pain and Depression', 'older adults with chronic low back pain (CLBP) and depression relative to opioid exposure', 'University-based late-life mental health research clinic', 'older patients']","['Serotonin norepinephrine reuptake inhibitors (SNRIs', 'venlafaxine', 'nonopioid', 'morphine equivalent dosing (MED', 'stepped-care approach', 'Venlafaxine']","['pain and mood response', 'analgesic response', 'pain response', 'Pain and depression', 'Depression response']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0035168'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C4521489', 'cui_str': 'Norepinephrine reuptake inhibitor (disposition)'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",227.0,0.102578,"Depression response was not impacted. ","[{'ForeName': 'Sarah T', 'Initials': 'ST', 'LastName': 'Stahl', 'Affiliation': 'Departments of Psychiatry.'}, {'ForeName': 'Changgi', 'Initials': 'C', 'LastName': 'Jung', 'Affiliation': 'Departments of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Debra K', 'Initials': 'DK', 'LastName': 'Weiner', 'Affiliation': 'Departments of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Peciña', 'Affiliation': 'Departments of Psychiatry.'}, {'ForeName': 'Jordan F', 'Initials': 'JF', 'LastName': 'Karp', 'Affiliation': 'Departments of Psychiatry.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz279'] 189,32227222,A daytime nap restores hippocampal function and improves declarative learning.,"STUDY OBJECTIVES Daytime naps can confer benefits on subsequent declarative learning, but the physiological correlates of this improvement are less well studied. We examined learning following a daytime nap compared with an equivalent waking period using fMRI and polysomnography. METHODS Forty healthy young adults who slept normally the previous night encoded word pair lists in an MRI scanner at 13:00 and 16:30. Between sessions, participants either stayed awake and watched a documentary (Wake Group; N = 20) or had a 90-minute nap opportunity (Nap Group; N = 20) monitored by polysomnography. Approximately 40 minutes after completing each encoding session, memory for learned words was assessed using cued-recall. RESULTS A significant Session × Group interaction effect (p < 0.001) was observed in which memory was significantly improved in the Nap but not in the Wake group (p < 0.001). There was also a Session × Run × Group interaction effect in the left hippocampus (p = 0.001), whereby activation during word pair encoding increased only following the nap. Both performance improvement (rs = 0.46, p = 0.04) and nap-related increase in hippocampal activation (rs = 0.46, p = 0.04) were correlated with nap spindle count (12-15 Hz) but not with slow oscillation power (p's ≥ 0.18). CONCLUSIONS After a habitual nocturnal sleep, participants who had a 90-minute afternoon nap encoded word pairs better than a comparable group who stayed awake. Increases in hippocampal activation following the nap suggest restored hippocampal function. Naptime spindles may contribute to improved memory.",2020,A significant Session x Group interaction effect (p<0.001) was observed in which memory was significantly improved in the Nap but not in the Wake group (p<0.001).,['Forty healthy young adults who slept normally the previous night encoded word pair lists in an MRI scanner at 1PM and 4.30PM'],"['daytime nap compared to an equivalent waking period using fMRI and polysomnography (PSG', 'stayed awake and watched a documentary (Wake Group; N=20) or had a 90-min nap opportunity (Nap Group; N=20) monitored by PSG']","['hippocampal activation', 'nap spindle count', 'activation during word-pair encoding', 'declarative learning', 'Daytime naps']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0067518', 'cui_str': 'NAPS'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C0234422', 'cui_str': 'Awake (finding)'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}]","[{'cui': 'C0067518', 'cui_str': 'NAPS'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}]",40.0,0.0374208,A significant Session x Group interaction effect (p<0.001) was observed in which memory was significantly improved in the Nap but not in the Wake group (p<0.001).,"[{'ForeName': 'Ju Lynn', 'Initials': 'JL', 'LastName': 'Ong', 'Affiliation': 'Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Te Yang', 'Initials': 'TY', 'LastName': 'Lau', 'Affiliation': 'Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Xuan Kai', 'Initials': 'XK', 'LastName': 'Lee', 'Affiliation': 'Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'van Rijn', 'Affiliation': 'Center for Cognitive Neuroscience, Neuroscience & Behavioral Disorders Programme, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Michael W L', 'Initials': 'MWL', 'LastName': 'Chee', 'Affiliation': 'Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}]",Sleep,['10.1093/sleep/zsaa058'] 190,32227216,Topiramate reduces nocturnal eating in sleep-related eating disorder.,"STUDY OBJECTIVES Sleep-related eating disorder (SRED) is a parasomnia characterized by partial arousals from sleep with compulsive consumption of food with impaired level of awareness and memory for the event. Small case series' have demonstrated efficacy of topiramate in SRED. We conducted a placebo-controlled randomized clinical trial of topiramate to assess efficacy in SRED. METHODS Thirty-four participants with an ICSD-2/ICSD-3 diagnosis of SRED with >6 months of symptoms and ≥3 sleep-related eating episodes per week were randomized to placebo or topiramate with flexible dosing to a maximum dosage of 300 mg for 13 weeks. Primary outcomes were percentage of nights with eating and Clinician Global Impression-Improvement (CGI-I). Intention-to-treat last observation carried forward (ITT LOCF) analysis was conducted. RESULTS Mean age was 39.5 years, 74% were female, with mean duration of sleep-related eating of 13.7 years. SRED symptoms were significantly reduced with topiramate (74.7% to 33.2% nights/week; n = 15) compared to placebo (77.0% to 57.4%; n = 17) (p = 0.035). There were significantly more CGI-I responders on topiramate (71%) than placebo (27%) (p = 0.016). Level of wakefulness (r = -0.49) and memory for nighttime eating (r = -0.58) at baseline predicted topiramate response. The topiramate group lost significantly more weight than the placebo group (-8.5 lbs vs. +1.0 lbs, p = 0.001). The most common side effects were paresthesias and cognitive dysfunction. CONCLUSIONS This first randomized controlled trial demonstrating efficacy for treatment of SRED supports preliminary data on the use of topiramate for SRED. Side effects were prominent for topiramate. Limitations include a small sample size and a high drop-out rate in both study groups. CLINICAL TRIAL INFORMATION NCT00606411.",2020,SRED symptoms were significantly reduced with topiramate (74.7% to 33.2% nights/week; n=15) compared to placebo (77.0% to 57.4%; n=17) (p=0.035).,"['sleep-related eating disorder', 'Sleep-Related Eating Disorder (SRED', 'Thirty-four subjects with an ICSD-2/ICSD-3 diagnosis of SRED with >6 months of symptoms and ≥3 sleep-related eating episodes per week', 'Mean age was 39.5 years, 74% were female, with mean duration of sleep-related eating of 13.7 years']","['placebo or topiramate', 'topiramate', 'Topiramate', 'placebo']","['paresthesias and cognitive dysfunction', 'percentage of nights with eating and CGI-I. Intention-to-treat last-observation-carried-forward (ITT LOCF) analysis', 'SRED symptoms', 'nocturnal eating', 'Level of wakefulness (r=-0.49) and memory for nighttime eating', 'weight', 'Side effects']","[{'cui': 'C1963717', 'cui_str': 'Sleep-related eating disorder'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep (observable entity)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0076829', 'cui_str': 'topiramate'}]","[{'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0043012', 'cui_str': 'Wakefulnesses'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",34.0,0.316903,SRED symptoms were significantly reduced with topiramate (74.7% to 33.2% nights/week; n=15) compared to placebo (77.0% to 57.4%; n=17) (p=0.035).,"[{'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Winkelman', 'Affiliation': 'Departments of Psychiatry and Neurology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Wipper', 'Affiliation': 'Departments of Psychiatry and Neurology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Purks', 'Affiliation': 'Larner College of Medicine at the University of Vermont, Burlington, VT.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Mei', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Schoerning', 'Affiliation': 'University of Massachusetts Medical School, Worcester, MA.'}]",Sleep,['10.1093/sleep/zsaa060'] 191,32227220,The effects of sleep deprivation and text messaging on pedestrian safety in university students.,"STUDY OBJECTIVES This study assesses the impact of sleep deprivation and text messaging on pedestrian injury risk. METHODS A total of 36 university students engaged in a virtual reality pedestrian environment in two conditions: sleep deprived (no sleep previous night) and normal sleep (normal sleep routine). Sleep was assessed using actigraphy and pedestrian behavior via four outcomes: time to initiate crossing, time before contact with oncoming vehicle, hits/close calls, and looks left/right. During each condition, participants made half the crossings while text messaging. Participants also completed the Useful Field of View test, the Psychomotor Vigilance Test, and Conners' Continuous Performance Test in both conditions. RESULTS While sleep deprived, students crossed significantly closer to oncoming vehicles compared with after normal sleep. While text messaging, crossed closer to vehicles and took longer to initiate crossings. Safety risks were amplified through combined sleep deprivation plus text messaging, leading to more virtual hits and close calls and shorter time before vehicle contact while crossing. Sleep-deprived students demonstrated impairments in functioning on cognitive tests. CONCLUSIONS University students' pedestrian behavior was generally riskier, and their cognitive functioning was impaired, when sleep deprived compared with after normal sleep. This effect was exacerbated when distracted by text messaging.",2020,"Safety risks were amplified through combined sleep deprivation plus text messaging, leading to more virtual hits and close calls and shorter time before vehicle contact while crossing.","['Thirty-six university students engaged in a', 'university students', 'University students']","['virtual reality pedestrian environment in two conditions: sleep deprived (no sleep previous night) and normal sleep (normal sleep routine', 'sleep deprivation and text messaging']","['Safety risks', 'pedestrian behavior', 'Sleep', 'actigraphy and pedestrian behavior via four outcomes: time to initiate crossing, time before contact with oncoming vehicle, hits/close calls, and looks left/right']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0450063', 'cui_str': 'Pedestrians'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0037316', 'cui_str': 'Sleep Deprivation'}, {'cui': 'C3178908', 'cui_str': 'Texting'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0450063', 'cui_str': 'Pedestrians'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332158', 'cui_str': 'Contact with (contextual qualifier) (qualifier value)'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}, {'cui': 'C0596020', 'cui_str': 'Does hit (finding)'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}]",,0.0342278,"Safety risks were amplified through combined sleep deprivation plus text messaging, leading to more virtual hits and close calls and shorter time before vehicle contact while crossing.","[{'ForeName': 'Aaron D', 'Initials': 'AD', 'LastName': 'Fobian', 'Affiliation': 'Department of Psychiatry, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Rouse', 'Affiliation': 'Department of Psychology, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Lindsay M', 'Initials': 'LM', 'LastName': 'Stager', 'Affiliation': 'Department of Psychology, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Dustin', 'Initials': 'D', 'LastName': 'Long', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Schwebel', 'Affiliation': 'Department of Psychology, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Kristin T', 'Initials': 'KT', 'LastName': 'Avis', 'Affiliation': 'Department of Psychology, University of Alabama at Birmingham, Birmingham, AL.'}]",Sleep,['10.1093/sleep/zsaa057'] 192,31899552,Multimodal psychosocial intervention for family caregivers of patients undergoing hematopoietic stem cell transplantation: A randomized clinical trial.,"BACKGROUND Caregivers of patients undergoing hematopoietic stem cell transplantation (HCT) experience an immense caregiving burden before, during, and after HCT. METHODS We conducted an unblinded, randomized trial of a psychosocial intervention (BMT-CARE) for caregivers of patients undergoing autologous and allogeneic HCT at Massachusetts General Hospital. Caregivers were randomly assigned to BMT-CARE or usual care. BMT-CARE was tailored to the HCT trajectory and integrated treatment-related education and self-care with cognitive-behavioral skills to promote coping. Caregivers assigned to BMT-CARE met with a trained interventionist (a psychologist or a social worker) in person, via telephone, or via videoconferencing for 6 sessions starting before HCT and continuing up to day +60 after HCT. The primary endpoint was feasibility, which was defined as at least 60% of eligible caregivers enrolling and completing 50% or more of the intervention sessions. We assesed caregiver quality of life (QOL; Caregiver Oncology Quality of Life Questionnaire), caregiving burden (Caregiver Reaction Assessment), psychological distress (Hospital Anxiety and Depression Scale), self-efficacy (Cancer Self-Efficacy Scale-Transplant), and coping (Measures of Current Status) at baseline and 30 and 60 days after HCT. We used mixed linear effect models to assess the effect of BMT-CARE on outcomes longitudinally. RESULTS We enrolled 72.5% of eligible caregivers (100 of 138), and 80% attended 50% or more of the intervention sessions. Caregivers randomized to BMT-CARE reported improved QOL (B = 6.11; 95% CI, 3.50-8.71; P < .001), reduced caregiving burden (B = -6.02; 95% CI, -8.49 to -3.55; P < .001), lower anxiety (B = -2.18; 95% CI, -3.07 to -1.28; P < .001) and depression symptoms (B = -1.23; 95% CI, -1.92 to -0.54; P < .001), and improved self-efficacy (B = 7.22; 95% CI, 2.40-12.03; P = .003) and coping skills (B = 4.83; 95% CI, 3.04-6.94; P < .001) in comparison with the usual-care group. CONCLUSIONS A brief multimodal psychosocial intervention tailored for caregivers of HCT recipients is feasible and may improve QOL, mood, coping, and self-efficacy while reducing the caregiving burden during the acute HCT period.",2020,"Caregivers randomized to BMT-CARE reported improved QOL (B = 6.11; 95% CI, 3.50-8.71; P < .001), reduced caregiving burden (B = -6.02; 95% CI, -8.49 to -3.55; P < .001), lower anxiety (B = ","['Caregivers of patients undergoing hematopoietic stem cell transplantation (HCT) experience', 'We enrolled 72.5% of eligible caregivers (100 of 138), and 80% attended 50% or more of the intervention sessions', 'caregivers of patients undergoing autologous and allogeneic HCT at Massachusetts General Hospital', 'family caregivers of patients undergoing hematopoietic stem cell transplantation', 'caregivers of HCT recipients']","['Multimodal psychosocial intervention', 'psychosocial intervention (BMT-CARE', 'BMT-CARE', 'trained interventionist (a psychologist or a social worker) in person, via telephone, or via videoconferencing', 'BMT-CARE or usual care']","['QOL', 'reduced caregiving burden', 'coping skills', 'self-efficacy', 'QOL, mood, coping, and self-efficacy', 'caregiver quality of life (QOL; Caregiver Oncology Quality of Life Questionnaire), caregiving burden (Caregiver Reaction Assessment), psychological distress (Hospital Anxiety and Depression Scale), self-efficacy (Cancer Self-Efficacy Scale-Transplant), and coping (Measures of Current Status', 'lower anxiety', 'depression symptoms']","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0037444', 'cui_str': 'Social worker (occupation)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0222045'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.165701,"Caregivers randomized to BMT-CARE reported improved QOL (B = 6.11; 95% CI, 3.50-8.71; P < .001), reduced caregiving burden (B = -6.02; 95% CI, -8.49 to -3.55; P < .001), lower anxiety (B = ","[{'ForeName': 'Areej', 'Initials': 'A', 'LastName': 'El-Jawahri', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Jacobs', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Nelson', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Traeger', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Greer', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Showly', 'Initials': 'S', 'LastName': 'Nicholson', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Lauren P', 'Initials': 'LP', 'LastName': 'Waldman', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Alyssa L', 'Initials': 'AL', 'LastName': 'Fenech', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Annemarie D', 'Initials': 'AD', 'LastName': 'Jagielo', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': ""D'Alotto"", 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Horick', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Spitzer', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Zachariah', 'Initials': 'Z', 'LastName': 'DeFilipp', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Yi-Bin A', 'Initials': 'YA', 'LastName': 'Chen', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Temel', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}]",Cancer,['10.1002/cncr.32680'] 193,31633896,Metoprolol for the Prevention of Acute Exacerbations of COPD.,"BACKGROUND Observational studies suggest that beta-blockers may reduce the risk of exacerbations and death in patients with moderate or severe chronic obstructive pulmonary disease (COPD), but these findings have not been confirmed in randomized trials. METHODS In this prospective, randomized trial, we assigned patients between the ages of 40 and 85 years who had COPD to receive either a beta-blocker (extended-release metoprolol) or placebo. All the patients had a clinical history of COPD, along with moderate airflow limitation and an increased risk of exacerbations, as evidenced by a history of exacerbations during the previous year or the prescribed use of supplemental oxygen. We excluded patients who were already taking a beta-blocker or who had an established indication for the use of such drugs. The primary end point was the time until the first exacerbation of COPD during the treatment period, which ranged from 336 to 350 days, depending on the adjusted dose of metoprolol. RESULTS A total of 532 patients underwent randomization. The mean (±SD) age of the patients was 65.0±7.8 years; the mean forced expiratory volume in 1 second (FEV 1 ) was 41.1±16.3% of the predicted value. The trial was stopped early because of futility with respect to the primary end point and safety concerns. There was no significant between-group difference in the median time until the first exacerbation, which was 202 days in the metoprolol group and 222 days in the placebo group (hazard ratio for metoprolol vs. placebo, 1.05; 95% confidence interval [CI], 0.84 to 1.32; P = 0.66). Metoprolol was associated with a higher risk of exacerbation leading to hospitalization (hazard ratio, 1.91; 95% CI, 1.29 to 2.83). The frequency of side effects that were possibly related to metoprolol was similar in the two groups, as was the overall rate of nonrespiratory serious adverse events. During the treatment period, there were 11 deaths in the metoprolol group and 5 in the placebo group. CONCLUSIONS Among patients with moderate or severe COPD who did not have an established indication for beta-blocker use, the time until the first COPD exacerbation was similar in the metoprolol group and the placebo group. Hospitalization for exacerbation was more common among the patients treated with metoprolol. (Funded by the Department of Defense; BLOCK COPD ClinicalTrials.gov number, NCT02587351.).",2019,"Metoprolol was associated with a higher risk of exacerbation leading to hospitalization (hazard ratio, 1.91; 95% CI, 1.29 to 2.83).","['532 patients underwent randomization', 'patients between the ages of 40 and 85 years who had COPD to receive either a', 'patients who were already taking a beta-blocker or who had an established indication for the use of such drugs', 'patients with moderate or severe chronic obstructive pulmonary disease (COPD', 'Acute Exacerbations of COPD', 'patients with moderate or severe COPD']","['beta-blocker (extended-release metoprolol) or placebo', 'beta-blockers', 'placebo', 'metoprolol', 'metoprolol vs. placebo', 'Metoprolol']","['median time until the first exacerbation', 'frequency of side effects', 'time until the first COPD exacerbation', 'risk of exacerbations', 'time until the first exacerbation of COPD', 'Hospitalization for exacerbation', 'overall rate of nonrespiratory serious adverse events', 'mean forced expiratory volume']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0730607', 'cui_str': 'Severe chronic obstructive pulmonary disease (disorder)'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease (disorder)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]","[{'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0025859', 'cui_str': 'Metoprolol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}]",532.0,0.447618,"Metoprolol was associated with a higher risk of exacerbation leading to hospitalization (hazard ratio, 1.91; 95% CI, 1.29 to 2.83).","[{'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Dransfield', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Voelker', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Surya P', 'Initials': 'SP', 'LastName': 'Bhatt', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Brenner', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Casaburi', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Carolyn E', 'Initials': 'CE', 'LastName': 'Come', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'J Allen D', 'Initials': 'JAD', 'LastName': 'Cooper', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Curtis', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'MeiLan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Umur', 'Initials': 'U', 'LastName': 'Hatipoğlu', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Erika S', 'Initials': 'ES', 'LastName': 'Helgeson', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Vipul V', 'Initials': 'VV', 'LastName': 'Jain', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Kalhan', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kaminsky', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kaner', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Ken M', 'Initials': 'KM', 'LastName': 'Kunisaki', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Allison A', 'Initials': 'AA', 'LastName': 'Lambert', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Lammi', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lindberg', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Barry J', 'Initials': 'BJ', 'LastName': 'Make', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'McEvoy', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Ralph J', 'Initials': 'RJ', 'LastName': 'Panos', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Reed', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Scanlon', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Frank C', 'Initials': 'FC', 'LastName': 'Sciurba', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Peruvemba S', 'Initials': 'PS', 'LastName': 'Sriram', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Stringer', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Jeremy A', 'Initials': 'JA', 'LastName': 'Weingarten', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Wells', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Westfall', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Lazarus', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Connett', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1908142'] 194,31808785,Framing the Opioid Crisis: Do Racial Frames Shape Beliefs of Whites Losing Ground?,"CONTEXT Although research has begun to examine perceptions of being on the losing side of politics, it has been confined to electoral politics. The context of health disparities, and particularly the opioid crisis, offers a case to explore whether frames that emphasize racial disadvantage activate loser perceptions and the political consequences of such beliefs. METHODS White survey participants (N = 1,549) were randomized into three groups: a control which saw no news article, or one of two treatment groups which saw a news article about the opioid crisis framed to emphasize either the absolute rates of opioid mortality among whites or the comparative rates of opioid mortality among whites compared to blacks. FINDINGS Among control group participants, perceiving oneself a political loser was unrelated to attitudes about addressing opioids, whereas those who perceived whites to be on the losing side of public health had a less empathetic response to the opioid crisis. The comparative frame led to greater beliefs that whites are on the losing side of public health, whereas the absolute frame led to more empathetic policy opinions. CONCLUSIONS Perceptions that one's racial group has lost ground in the public health context could have political consequences that future research should explore.",2020,"FINDINGS Among control group participants, perceiving oneself a political loser was unrelated to attitudes about addressing opioids, whereas those who perceived whites to be on the losing side of public health had a less empathetic response to the opioid crisis.","['White survey participants (N\u2009=\u20091,549']",[],['empathetic response'],"[{'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",[],[],1549.0,0.0142184,"FINDINGS Among control group participants, perceiving oneself a political loser was unrelated to attitudes about addressing opioids, whereas those who perceived whites to be on the losing side of public health had a less empathetic response to the opioid crisis.","[{'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Gollust', 'Affiliation': 'University of Minnesota.'}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'University of Delaware.'}]","Journal of health politics, policy and law",['10.1215/03616878-8004874'] 195,31808786,Public Preferences for New Information on Opioids.,"CONTEXT Educating the public through information campaigns is a commonly used policy approach to public health problems. Yet, experimental methods that assess the impact of information campaigns may misestimate their effects by failing to account for respondents' willingness to receive new information. METHODS This article uses a doubly randomized survey experiment conducted on a nationally representative sample, where some subjects are randomly assigned to an informational treatment about opioids while other subjects are given the choice of whether to receive treatment or not, to examine how public willingness to seek new information shapes the way they update their preferences about policies related to the opioid epidemic. FINDINGS Among those likely to receive information, treatment has a large positive effect on increasing support for policies that address the opioid epidemic by about one half of a standard deviation. Among those who would avoid this information, preferences appear to be unmoved by treatment. These effects would be missed by standard experimental designs. CONCLUSION While redressing information asymmetries is only one part of a public health strategy for addressing the opioid epidemic, our findings highlight the importance of access to and receptiveness toward new information.",2020,"Among those likely to receive information, treatment has a large positive effect on increasing support for policies that address the opioid epidemic by about one half of a standard deviation.",[],[],[],[],[],[],,0.0422388,"Among those likely to receive information, treatment has a large positive effect on increasing support for policies that address the opioid epidemic by about one half of a standard deviation.","[{'ForeName': 'Paul F', 'Initials': 'PF', 'LastName': 'Testa', 'Affiliation': 'Brown University.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Moffitt', 'Affiliation': 'Brown University.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Schenk', 'Affiliation': 'Brown University.'}]","Journal of health politics, policy and law",['10.1215/03616878-8004898'] 196,32037861,Phase I randomized single-blinded controlled study investigating the potential benefit of aerobic exercise in degenerative cerebellar disease.,"OBJECTIVES To investigate whether people with cerebellar degeneration can perform rigorous aerobic exercise and to assess the clinical impact of training. DESIGN Randomized single-blinded controlled, feasibility study comparing aerobic training to no training. SETTING Home intervention, assessments conducted at an academic medical center. SUBJECTS Twenty individuals with cerebellar degeneration caused by a range of genetic disorders. INTERVENTION Aerobic training consisted of four weeks of stationary bicycle training, five times per week for 30-minute sessions. Intensity ranged from 65% to 80% of the participant's maximal heart rate determined during cardiopulmonary exercise testing. MAIN MEASURES Primary outcome measure was change in the Scale for the Assessment and Rating of Ataxia scores. Recruitment rate, adherence, drop-out, and adverse events were also determined. The treatment was considered technically feasible if participants achieved target training frequency, duration, and intensity. RESULTS The 20 participants mean age was 50 years (standard deviation 15.65 years) and average Scale for the Assessment and Rating of Ataxia score was 9.6 (standard deviation 3.13). Ten participants were randomized to aerobic training and 10 to no training. Seven participants in the aerobic group attained target training duration, frequency, and intensity. There was a mean reduction in ataxia severity of 2.1 points (standard deviation 1.26) with four weeks of aerobic training, whereas ataxia severity increased by 0.3 (standard deviation 0.62) in the control group over the same period. Walking speed, balance measures, and fitness also improved in individuals who performed aerobic exercise. CONCLUSIONS Rigorous aerobic training is feasible in people with cerebellar degeneration. Improvements in ataxia, balance, and gait are promising.",2020,"There was a mean reduction in ataxia severity of 2.1 points (standard deviation 1.26) with four weeks of aerobic training, whereas ataxia severity increased by 0.3 (standard deviation 0.62) in the control group over the same period.","['Twenty individuals with cerebellar degeneration caused by a range of genetic disorders', 'degenerative cerebellar disease', 'people with cerebellar degeneration', 'Home intervention, assessments conducted at an academic medical center', '20 participants mean age was 50\u2009years (standard deviation 15.65\u2009years) and average Scale for the Assessment and Rating of Ataxia score was 9.6 (standard deviation 3.13']","['aerobic training to no training', 'aerobic training', 'aerobic exercise', 'Aerobic training consisted of four weeks of stationary bicycle training', 'aerobic training and 10 to no training']","['target training duration, frequency, and intensity', 'maximal heart rate', 'ataxia, balance, and gait', 'Walking speed, balance measures, and fitness', 'target training frequency, duration, and intensity', 'change in the Scale for the Assessment and Rating of Ataxia scores', 'ataxia severity', 'Recruitment rate, adherence, drop-out, and adverse events']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0262404', 'cui_str': 'Cerebellar degeneration'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0019247', 'cui_str': 'Hereditary Diseases'}, {'cui': 'C0007760', 'cui_str': 'Cerebellum Diseases'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0222045'}, {'cui': 'C0004134', 'cui_str': 'Dyssynergia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439835', 'cui_str': 'Stationary (qualifier value)'}, {'cui': 'C0005375', 'cui_str': 'Bicycle, device (physical object)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0004134', 'cui_str': 'Dyssynergia'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0222045'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",10.0,0.0460504,"There was a mean reduction in ataxia severity of 2.1 points (standard deviation 1.26) with four weeks of aerobic training, whereas ataxia severity increased by 0.3 (standard deviation 0.62) in the control group over the same period.","[{'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Barbuto', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Vagelos College of Physicians and Surgeons, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Martelli', 'Affiliation': 'Department of Mechanical Engineering, Columbia University, New York, NY, USA.'}, {'ForeName': 'Isarime Babajide', 'Initials': 'IB', 'LastName': 'Omofuma', 'Affiliation': 'Department of Mechanical Engineering, Columbia University, New York, NY, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Vagelos College of Physicians and Surgeons, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Sheng-Han', 'Initials': 'SH', 'LastName': 'Kuo', 'Affiliation': 'Department of Neurology, Vagelos College of Physicians and Surgeons, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': 'Department of Mechanical Engineering, Columbia University, New York, NY, USA.'}, {'ForeName': 'Seonjoo', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Biostatistics, Vagelos College of Physicians and Surgeons, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': ""O'Dell"", 'Affiliation': 'Department of Rehabilitation Medicine, Weill Cornell Medical College, Cornell University, New York, NY, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Stein', 'Affiliation': 'Department of Rehabilitation Medicine, Weill Cornell Medical College, Cornell University, New York, NY, USA.'}]",Clinical rehabilitation,['10.1177/0269215520905073'] 197,32220517,The BlastGen study: a randomized controlled trial of blastocyst media supplemented with granulocyte-macrophage colony-stimulating factor.,"RESEARCH QUESTION Does Embryogen®/BlastGen™ culture medium improve live birth rates compared with standard culture medium for women undergoing IVF and intracytoplasmic sperm injection (ICSI) with poor prognosis. DESIGN Randomized clinical trial. A total of 100 couples undergoing IVF/ICSI were randomly allocated to having their inseminated oocytes incubated in either Embryogen®/BlastGen™ sequential culture media or standard Cleavage/Blastocyst sequential culture media for 5 days (ClinicalTrials.gov Identifier: NCT02305420). RESULTS No statistically significant difference in live birth rate was found between the control group and the Embryogen®/BlastGen™ group (17 [34%] versus 11 [22%], respectively) (OR 0.55; 95% CI 0.22 to 1.32; P = 0.18). After adjustment for maternal age, body mass index and fertilization procedure, the blastulation rate reduced (40.6 ± 26.5 versus 24.6 ± 26.7; RR 0.70, CI 0.52 to 0.95; P < 0.05), and grade of the embryo transferred (OR 0.35, CI 0.16 to 0.77; P < 0.01) when Embryogen®/BlastGen™ medium was used. CONCLUSION A significant reduction in day-5 embryo outcome parameters was found using Embryogen®/BlastGen™ compared with standard medium, and insufficient evidence of a difference in pregnancy outcomes. Taking into consideration the small samples size, study limitations and strict inclusion criteria of this single-centre study, further research is needed to determine the efficacy of Embryogen®/BlastGen™ medium in couples undergoing IVF/ICSI.",2020,"A significant reduction in day-5 embryo outcome parameters was found using Embryogen®/BlastGen™ compared with standard medium, and insufficient evidence of a difference in pregnancy outcomes.","['couples undergoing IVF/ICSI', '100 couples undergoing IVF/ICSI', 'women undergoing IVF and intracytoplasmic sperm injection (ICSI) with poor prognosis']","['Embryogen®/BlastGen', 'having their inseminated oocytes incubated in either Embryogen®/BlastGen™ sequential culture media or standard Cleavage/Blastocyst sequential culture media', 'blastocyst media supplemented with granulocyte-macrophage colony-stimulating factor']","['blastulation rate', 'grade of the embryo transferred', 'live birth rates', 'live birth rate']","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0278252', 'cui_str': 'Prognosis bad (finding)'}]","[{'cui': 'C0029045', 'cui_str': 'Ovocytes'}, {'cui': 'C0010454', 'cui_str': 'Culture Media'}, {'cui': 'C0005705', 'cui_str': 'Embryo stage 3 structure'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}]",100.0,0.22946,"A significant reduction in day-5 embryo outcome parameters was found using Embryogen®/BlastGen™ compared with standard medium, and insufficient evidence of a difference in pregnancy outcomes.","[{'ForeName': 'Ryan D', 'Initials': 'RD', 'LastName': 'Rose', 'Affiliation': 'Fertility SA, St Andrews Hospital, 350 South Terrace, Adelaide SA 5000, Australia; Adelaide Health and Medical Sciences, Robinson Research Institute, The University of Adelaide, AHMS Building, North Terrace, Adelaide SA 5005, Australia. Electronic address: ryan.rose@adelaide.edu.au.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Barry', 'Affiliation': 'Fertility SA, St Andrews Hospital, 350 South Terrace, Adelaide SA 5000, Australia; Adelaide Health and Medical Sciences, Robinson Research Institute, The University of Adelaide, AHMS Building, North Terrace, Adelaide SA 5005, Australia.'}, {'ForeName': 'Emma V', 'Initials': 'EV', 'LastName': 'Dunstan', 'Affiliation': 'Fertility SA, St Andrews Hospital, 350 South Terrace, Adelaide SA 5000, Australia.'}, {'ForeName': 'Siu Man', 'Initials': 'SM', 'LastName': 'Yuen', 'Affiliation': 'Adelaide Health and Medical Sciences, Robinson Research Institute, The University of Adelaide, AHMS Building, North Terrace, Adelaide SA 5005, Australia.'}, {'ForeName': 'Lyndal P', 'Initials': 'LP', 'LastName': 'Cameron', 'Affiliation': 'Fertility SA, St Andrews Hospital, 350 South Terrace, Adelaide SA 5000, Australia.'}, {'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Knight', 'Affiliation': 'School of Public Health, Robinson Research Institute, AHMS Building, The University of Adelaide, North Terrace, Adelaide5005 SA, Australia.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Norman', 'Affiliation': 'Fertility SA, St Andrews Hospital, 350 South Terrace, Adelaide SA 5000, Australia; Adelaide Health and Medical Sciences, Robinson Research Institute, The University of Adelaide, AHMS Building, North Terrace, Adelaide SA 5005, Australia.'}, {'ForeName': 'M Louise', 'Initials': 'ML', 'LastName': 'Hull', 'Affiliation': 'Fertility SA, St Andrews Hospital, 350 South Terrace, Adelaide SA 5000, Australia; Adelaide Health and Medical Sciences, Robinson Research Institute, The University of Adelaide, AHMS Building, North Terrace, Adelaide SA 5005, Australia.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.01.011'] 198,32065623,"Clinical Effects of the Self-administered Subcutaneous Complement Inhibitor Zilucoplan in Patients With Moderate to Severe Generalized Myasthenia Gravis: Results of a Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial.","Importance Many patients with generalized myasthenia gravis (gMG) have substantial clinical disability, persistent disease burden, and adverse effects attributable to chronic immunosuppression. Therefore, there is a significant need for targeted, well-tolerated therapies with the potential to improve disease control and enhance quality of life. Objective To evaluate the clinical effects of zilucoplan, a subcutaneously (SC) self-administered macrocyclic peptide inhibitor of complement component 5, in a broad population of patients with moderate to severe gMG. Design, Setting, and Participants This randomized, double-blind, placebo-controlled phase 2 clinical trial at 25 study sites across North America recruited participants between December 2017 and August 2018. Fifty-seven patients were screened, of whom 12 did not meet inclusion criteria and 1 was lost to follow-up after randomization but before receiving study drug, resulting in a total of 44 acetylcholine receptor autoantibody (AChR-Ab)-positive patients with gMG with baseline Quantitative Myasthenia Gravis (QMG) scores of at least 12, regardless of treatment history. Interventions Patients were randomized 1:1:1 to a daily SC self-injection of placebo, 0.1-mg/kg zilucoplan, or 0.3-mg/kg zilucoplan for 12 weeks. Main Outcomes and Measures The primary and key secondary end points were the change from baseline to week 12 in QMG and MG Activities of Daily Living scores, respectively. Significance testing was prespecified at a 1-sided α of .10. Safety and tolerability were also assessed. Results The study of 44 patients was well balanced across the 3 treatment arms with respect to key demographic and disease-specific variables. The mean age of patients across all 3 treatment groups ranged from 45.5 to 54.6 years and most patients were white (average proportions across 3 treatment groups: 78.6%-86.7%). Clinically meaningful and statistically significant improvements in primary and key secondary efficacy end points were observed. Zilucoplan at a dose of 0.3 mg/kg SC daily resulted in a mean reduction from baseline of 6.0 points in the QMG score (placebo-corrected change, -2.8; P = .05) and 3.4 points in the MG Activities of Daily Living score (placebo-corrected change, -2.3; P = .04). Clinically meaningful and statistically significant improvements were also observed in other secondary end points, the MG Composite and MG Quality-of-Life scores. Outcomes for the 0.1-mg/kg SC daily dose were also statistically significant but slower in onset and less pronounced than with the 0.3-mg/kg dose. Rescue therapy (intravenous immunoglobulin or plasma exchange) was required in 3 of 15, 1 of 15, and 0 of 14 participants in the placebo, 0.1-mg/kg zilucoplan, and 0.3-mg/kg zilucoplan arms, respectively. Zilucoplan was observed to have a favorable safety and tolerability profile. Conclusions and Relevance Zilucoplan yielded rapid, meaningful, and sustained improvements over 12 weeks in a broad population of patients with moderate to severe AChR-Ab-positive gMG. Near-complete complement inhibition appeared superior to submaximal inhibition. The observed safety and tolerability profile of zilucoplan was favorable. Trial Registration ClinicalTrials.gov Identifier: NCT03315130.",2020,"Clinically meaningful and statistically significant improvements were also observed in other secondary end points, the MG Composite and MG Quality-of-Life scores.","['44 patients was well balanced across the 3 treatment arms with respect to key demographic and disease-specific variables', 'Patients With Moderate to Severe Generalized Myasthenia Gravis', 'patients with generalized myasthenia gravis (gMG', '25 study sites across North America recruited participants between December 2017 and August 2018', 'Fifty-seven patients were screened, of whom 12 did not meet inclusion criteria and 1 was lost to follow-up after randomization but before receiving study drug, resulting in a total of 44 acetylcholine receptor autoantibody (AChR-Ab)-positive patients with gMG with baseline Quantitative Myasthenia Gravis (QMG) scores of at least 12, regardless of treatment history', 'patients with moderate to severe gMG']","['zilucoplan', 'placebo', 'zilucoplan, a subcutaneously (SC) self-administered macrocyclic peptide inhibitor', 'Self-administered Subcutaneous Complement Inhibitor Zilucoplan', 'daily SC self-injection of placebo, 0.1-mg/kg zilucoplan, or 0.3-mg/kg zilucoplan', 'Rescue therapy (intravenous immunoglobulin or plasma exchange', 'placebo, 0.1-mg/kg zilucoplan, and 0.3-mg/kg zilucoplan', 'Zilucoplan', 'Placebo']","['QMG and MG Activities of Daily Living scores', 'favorable safety and tolerability profile', 'MG Composite and MG Quality-of-Life scores', 'Daily Living score', 'QMG score', 'Safety and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0751339', 'cui_str': 'Myasthenia Gravis, Generalized'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia Gravis'}, {'cui': 'C0765796', 'cui_str': 'GMG'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0034792', 'cui_str': 'Receptors, Acetylcholine'}, {'cui': 'C0004358', 'cui_str': 'Autoantibodies'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C1564892', 'cui_str': 'Complement Inactivating Agents'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}, {'cui': 'C0032113', 'cui_str': 'Plasma Exchange'}]","[{'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",57.0,0.514858,"Clinically meaningful and statistically significant improvements were also observed in other secondary end points, the MG Composite and MG Quality-of-Life scores.","[{'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Howard', 'Affiliation': 'University of North Carolina, Chapel Hill.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Nowak', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Gil I', 'Initials': 'GI', 'LastName': 'Wolfe', 'Affiliation': 'University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Miriam L', 'Initials': 'ML', 'LastName': 'Freimer', 'Affiliation': 'Ohio State University, Columbus.'}, {'ForeName': 'Tuan H', 'Initials': 'TH', 'LastName': 'Vu', 'Affiliation': 'University of South Florida, Tampa.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Hinton', 'Affiliation': 'Infirmary Health, Mobile, Alabama.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Benatar', 'Affiliation': 'University of Miami, Miami, Florida.'}, {'ForeName': 'Petra W', 'Initials': 'PW', 'LastName': 'Duda', 'Affiliation': 'Ra Pharmaceuticals Inc, Cambridge, Massachusetts.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'MacDougall', 'Affiliation': 'Ra Pharmaceuticals Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Farzaneh-Far', 'Affiliation': 'Ra Pharmaceuticals Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Henry J', 'Initials': 'HJ', 'LastName': 'Kaminski', 'Affiliation': 'George Washington University, Washington, DC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Barohn', 'Affiliation': 'University of Kansas, Fairway.'}, {'ForeName': 'Mazen', 'Initials': 'M', 'LastName': 'Dimachkie', 'Affiliation': 'University of Kansas, Fairway.'}, {'ForeName': 'Mamatha', 'Initials': 'M', 'LastName': 'Pasnoor', 'Affiliation': 'University of Kansas, Fairway.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Farmakidis', 'Affiliation': 'University of Kansas, Fairway.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'University of Kansas, Fairway.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Colgan', 'Affiliation': 'University of Kansas, Fairway.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Benatar', 'Affiliation': 'University of Miami, Miami, Florida.'}, {'ForeName': 'Tulio', 'Initials': 'T', 'LastName': 'Bertorini', 'Affiliation': 'Wesley Neurology Clinic, Cordova, Tennessee.'}, {'ForeName': 'Rekha', 'Initials': 'R', 'LastName': 'Pillai', 'Affiliation': 'Wesley Neurology Clinic, Cordova, Tennessee.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Henegar', 'Affiliation': 'Wesley Neurology Clinic, Cordova, Tennessee.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Bromberg', 'Affiliation': 'University of Utah, Salt Lake City.'}, {'ForeName': 'Summer', 'Initials': 'S', 'LastName': 'Gibson', 'Affiliation': 'University of Utah, Salt Lake City.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Janecki', 'Affiliation': 'University of Utah, Salt Lake City.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Freimer', 'Affiliation': 'Ohio State University, Columbus.'}, {'ForeName': 'Bakri', 'Initials': 'B', 'LastName': 'Elsheikh', 'Affiliation': 'Ohio State University, Columbus.'}, {'ForeName': 'Paige', 'Initials': 'P', 'LastName': 'Matisak', 'Affiliation': 'Ohio State University, Columbus.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Genge', 'Affiliation': 'Montreal Neurological Institute, Montreal, Quebec, Canada.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Guidon', 'Affiliation': 'Massachusetts General Hospital, Boston.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'David', 'Affiliation': 'Massachusetts General Hospital, Boston.'}, {'ForeName': 'Ali A', 'Initials': 'AA', 'LastName': 'Habib', 'Affiliation': 'University of California, Irvine, Orange.'}, {'ForeName': 'Veena', 'Initials': 'V', 'LastName': 'Mathew', 'Affiliation': 'University of California, Irvine, Orange.'}, {'ForeName': 'Tahseen', 'Initials': 'T', 'LastName': 'Mozaffar', 'Affiliation': 'University of California, Irvine, Orange.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Hinton', 'Affiliation': 'Infirmary Health, Mobile, Alabama.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hewitt', 'Affiliation': 'Infirmary Health, Mobile, Alabama.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Barnett', 'Affiliation': 'Infirmary Health, Mobile, Alabama.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Sullivan', 'Affiliation': 'Infirmary Health, Mobile, Alabama.'}, {'ForeName': 'Doreen', 'Initials': 'D', 'LastName': 'Ho', 'Affiliation': 'Lahey Hospital, Burlington, Massachusetts.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Howard', 'Affiliation': 'University of North Carolina, Chapel Hill.'}, {'ForeName': 'Rebecca E', 'Initials': 'RE', 'LastName': 'Traub', 'Affiliation': 'University of North Carolina, Chapel Hill.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Chopra', 'Affiliation': 'University of North Carolina, Chapel Hill.'}, {'ForeName': 'Henry J', 'Initials': 'HJ', 'LastName': 'Kaminski', 'Affiliation': 'George Washington University, Washington, DC.'}, {'ForeName': 'Radwa', 'Initials': 'R', 'LastName': 'Aly', 'Affiliation': 'George Washington University, Washington, DC.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Bayat', 'Affiliation': 'George Washington University, Washington, DC.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Abu-Rub', 'Affiliation': 'George Washington University, Washington, DC.'}, {'ForeName': 'Shaida', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'University of Texas Southwestern, Dallas, Irving.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Lange', 'Affiliation': 'Hospital for Special Surgery, New York, New York.'}, {'ForeName': 'Shara', 'Initials': 'S', 'LastName': 'Holzberg', 'Affiliation': 'Hospital for Special Surgery, New York, New York.'}, {'ForeName': 'Bhupendra', 'Initials': 'B', 'LastName': 'Khatri', 'Affiliation': 'Center for Neurological Disorders, St Francis Hospital at Ascension, Milwaukee, Wisconsin.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Lindman', 'Affiliation': 'Center for Neurological Disorders, St Francis Hospital at Ascension, Milwaukee, Wisconsin.'}, {'ForeName': 'Tayo', 'Initials': 'T', 'LastName': 'Olapo', 'Affiliation': 'Center for Neurological Disorders, St Francis Hospital at Ascension, Milwaukee, Wisconsin.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Sershon', 'Affiliation': 'Center for Neurological Disorders, St Francis Hospital at Ascension, Milwaukee, Wisconsin.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Lisak', 'Affiliation': 'Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Evanthia', 'Initials': 'E', 'LastName': 'Bernitsas', 'Affiliation': 'Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Jia', 'Affiliation': 'Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Rabia', 'Initials': 'R', 'LastName': 'Malik', 'Affiliation': 'Rush University, Chicago, Illinois.'}, {'ForeName': 'Tiffany D', 'Initials': 'TD', 'LastName': 'Lewis-Collins', 'Affiliation': 'Rush University, Chicago, Illinois.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nicolle', 'Affiliation': 'London Health Sciences Center, London, Ontario, Canada.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Nowak', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Bhaskar', 'Initials': 'B', 'LastName': 'Roy', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Nye', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pulley', 'Affiliation': 'University of Florida, Jacksonville.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Berger', 'Affiliation': 'University of Florida, Jacksonville.'}, {'ForeName': 'Yasmeen', 'Initials': 'Y', 'LastName': 'Shabbir', 'Affiliation': 'University of Florida, Jacksonville.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Sachdev', 'Affiliation': 'Michigan State University, East Lansing.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Patterson', 'Affiliation': 'Michigan State University, East Lansing.'}, {'ForeName': 'Zaeem', 'Initials': 'Z', 'LastName': 'Siddiqi', 'Affiliation': 'University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sivak', 'Affiliation': 'Mount Sinai Hospital, New York, New York.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Bratton', 'Affiliation': 'Mount Sinai Hospital, New York, New York.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Small', 'Affiliation': 'Allegheny Neurological Associates, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Anem', 'Initials': 'A', 'LastName': 'Kohli', 'Affiliation': 'Allegheny Neurological Associates, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Fetter', 'Affiliation': 'Allegheny Neurological Associates, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Tuan', 'Initials': 'T', 'LastName': 'Vu', 'Affiliation': 'University of South Florida, Tampa.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Lam', 'Affiliation': 'University of South Florida, Tampa.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Harvey', 'Affiliation': 'University of South Florida, Tampa.'}, {'ForeName': 'Gil I', 'Initials': 'GI', 'LastName': 'Wolfe', 'Affiliation': 'University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Silvestri', 'Affiliation': 'University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Patrick', 'Affiliation': 'University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Zakalik', 'Affiliation': 'University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Petra W', 'Initials': 'PW', 'LastName': 'Duda', 'Affiliation': 'Ra Pharmaceuticals Inc, Cambridge, Massachusetts.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'MacDougall', 'Affiliation': 'Ra Pharmaceuticals Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Farzaneh-Far', 'Affiliation': 'Ra Pharmaceuticals Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Pontius', 'Affiliation': 'Ra Pharmaceuticals Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hoarty', 'Affiliation': 'Ra Pharmaceuticals Inc, Cambridge, Massachusetts.'}]",JAMA neurology,['10.1001/jamaneurol.2019.5125'] 199,32219557,"Efficacy and safety of incobotulinumtoxinA in post-stroke upper-limb spasticity in Japanese subjects: results from a randomized, double-blind, placebo-controlled study (J-PURE).","BACKGROUND Upper-limb spasticity frequently occurs after stroke and there is a clinical need for more effective therapies. The Phase III J-PURE study assessed the efficacy and safety of incobotulinumtoxinA up to 400 U for post-stroke upper-limb spasticity in Japan. METHODS In the 12-week main period (MP) of this double-blind, placebo-controlled study, Japanese subjects with upper-limb spasticity received one injection cycle of incobotulinumtoxinA 400 U, 250 U, or matching placebo. Eligible subjects enrolled in an open-label extension (OLEX) period of three injection cycles of incobotulinumtoxinA 400 U (32-40 weeks). The primary objective was to establish the efficacy of a single incobotulinumtoxinA injection using the Modified Ashworth Scale (MAS) wrist score. Secondary efficacy outcomes and safety were also assessed. RESULTS Among 100 treated subjects, AUCs for incobotulinumtoxinA 400 and 250 U were significantly different versus placebo (p = 0.0014 and p = 0.0031, respectively) for change from baseline in MAS wrist score to the end of the MP, with similar results from baseline to week 4. IncobotulinumtoxinA 400 U was superior versus placebo across other spasticity patterns and at most study visits. Improvements were maintained throughout the OLEX period. Disability Assessment Scale and Investigator's Clinical Global Impression scores improved significantly for incobotulinumtoxinA 400 U versus placebo from baseline to week 4 (p = 0.0067 and p < 0.0001, respectively). IncobotulinumtoxinA was well tolerated up to 52 weeks, with no unexpected adverse events. CONCLUSION IncobotulinumtoxinA reduced (pathologically) increased muscle tone, improved functionality and was well tolerated in Japanese subjects with post-stroke upper-limb spasticity.",2020,"Disability Assessment Scale and Investigator's Clinical Global Impression scores improved significantly for incobotulinumtoxinA 400 U versus placebo from baseline to week 4 (p = 0.0067 and p < 0.0001, respectively).","['Eligible subjects enrolled in an open-label extension (OLEX) period of three injection cycles of incobotulinumtoxinA 400 U (32-40\xa0weeks', 'Japanese subjects with post-stroke upper-limb spasticity', 'Japanese subjects', 'Japan', 'Japanese subjects with upper-limb spasticity']","['incobotulinumtoxinA', 'single incobotulinumtoxinA injection', 'placebo', 'IncobotulinumtoxinA 400 U was superior versus placebo', 'IncobotulinumtoxinA', 'incobotulinumtoxinA 400 U, 250 U, or matching placebo']","['Efficacy and safety', 'efficacy and safety', 'Modified Ashworth Scale (MAS) wrist score', 'muscle tone, improved functionality and was well tolerated', 'MAS wrist score', ""Disability Assessment Scale and Investigator's Clinical Global Impression scores""]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C2930113', 'cui_str': 'incobotulinumtoxinA'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1273957', 'cui_str': 'Upper limb spasticity'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C2930113', 'cui_str': 'incobotulinumtoxinA'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale (assessment scale)'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0549465', 'cui_str': 'Muscle tone (observable entity)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C3854497', 'cui_str': 'Disability assessment scale'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",,0.358522,"Disability Assessment Scale and Investigator's Clinical Global Impression scores improved significantly for incobotulinumtoxinA 400 U versus placebo from baseline to week 4 (p = 0.0067 and p < 0.0001, respectively).","[{'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Masakado', 'Affiliation': 'Department of Rehabilitation Medicine, Tokai University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Abo', 'Affiliation': 'Department of Rehabilitation Medicine, The Jikei University Hospital, Tokyo, Japan.'}, {'ForeName': 'Kunitsugu', 'Initials': 'K', 'LastName': 'Kondo', 'Affiliation': 'Department of Rehabilitation Medicine, Tokyo Bay Rehabilitation Hospital, Chiba, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Saeki', 'Affiliation': 'Department of Rehabilitation Medicine, Hospital of the University of Occupational and Environmental Health, Fukuoka, Japan.'}, {'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Saitoh', 'Affiliation': 'Department of Rehabilitation Medicine I, School of Medicine, Fujita Health University, Aichi, Japan.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Dekundy', 'Affiliation': 'Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Hanschmann', 'Affiliation': 'Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.'}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Kaji', 'Affiliation': 'Department of Neurology, Tokushima University Hospital, Tokushima City, Tokushima, Japan. rkaji@tokushima-u.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of neurology,['10.1007/s00415-020-09777-5'] 200,32213642,Randomized placebo-controlled trial of the effects of aspirin on dementia and cognitive decline.,"OBJECTIVE To determine the effect of low-dose aspirin vs placebo on incident all-cause dementia, incident Alzheimer disease (AD), mild cognitive impairment (MCI), and cognitive decline in older individuals. METHODS Aspirin in Reducing Events in the Elderly (ASPREE) was a double-blind, placebo-controlled trial of low-dose aspirin. In the United States and Australia, community-dwelling individuals aged ≥70 years (US minorities ≥65 years) and free of cardiovascular disease, physical disability, and diagnosed dementia were enrolled. Participants were randomized 1:1-100 mg daily aspirin or placebo. The Modified Mini-Mental State Examination, Hopkins Verbal Learning Test-Revised, Symbol Digit Modalities Test, and Controlled Oral Word Association Test assessed cognition at baseline and over follow-up. Additional cognitive testing was performed in participants with suspected dementia (""trigger"") based on within-study assessments or clinical history. Dementia was adjudicated according to DSM-IV criteria. National Institute on Aging-Alzheimer's Association criteria were used for AD and MCI subclassification. RESULTS A total of 19,114 participants were followed over a median 4.7 years and 964 triggered further dementia assessments. There were 575 adjudicated dementia cases, and 41% were classified as clinically probable AD. There was no substantial difference in the risk of all dementia triggers (hazard ratio [HR], 1.03; 95% confidence interval [CI], 0.91-1.17), probable AD (HR, 0.96; 95% CI, 0.74-1.24), or MCI (HR, 1.12; 95% CI, 0.92-1.37) between aspirin and placebo. Cognitive change over time was similar in the aspirin and placebo groups. CONCLUSIONS There was no evidence that aspirin was effective in reducing risk of dementia, MCI, or cognitive decline. Follow-up of these outcomes after initial exposure is ongoing. CLASSIFICATION OF EVIDENCE This study provides Class II evidence that for healthy older individuals, low-dose aspirin does not significantly reduce the incidence of dementia, probable AD, MCI, or cognitive decline. CLINICALTRIALSGOV IDENTIFIER NCT01038583.",2020,"There was no substantial difference in the risk of all dementia triggers (hazard ratio [HR], 1.03; 95% confidence interval [CI], 0.91-1.17), probable AD (HR, 0.96; 95% CI, 0.74-1.24), or MCI (HR, 1.12; 95% CI, 0.92-1.37) between aspirin and placebo.","['incident all-cause dementia, incident Alzheimer disease (AD), mild cognitive impairment (MCI), and cognitive decline in older individuals', 'healthy older individuals', 'A total of 19,114 participants were followed over a median 4.7 years and 964 triggered further dementia assessments', 'United States and Australia, community-dwelling individuals aged ≥70 years (US minorities ≥65 years) and free of cardiovascular disease, physical disability, and diagnosed dementia were enrolled', 'participants with suspected dementia (""trigger"") based on within-study assessments or clinical history']","['aspirin', 'Aspirin', 'placebo', 'aspirin or placebo', 'aspirin vs placebo']","['risk of all dementia triggers', 'Modified Mini-Mental State Examination, Hopkins Verbal Learning Test-Revised, Symbol Digit Modalities Test, and Controlled Oral Word Association Test assessed cognition', 'dementia and cognitive decline', 'Cognitive change over time', 'incidence of dementia, probable AD, MCI, or cognitive decline', 'risk of dementia, MCI, or cognitive decline']","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0234985', 'cui_str': 'Cognitive Decline'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap (finding)'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0042531', 'cui_str': 'Verbal Learning'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0451522', 'cui_str': 'Symbol Digit Modalities Test'}, {'cui': 'C3827022', 'cui_str': 'Controlled Oral Word Association Test'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0234985', 'cui_str': 'Cognitive Decline'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}]",19114.0,0.630076,"There was no substantial difference in the risk of all dementia triggers (hazard ratio [HR], 1.03; 95% confidence interval [CI], 0.91-1.17), probable AD (HR, 0.96; 95% CI, 0.74-1.24), or MCI (HR, 1.12; 95% CI, 0.92-1.37) between aspirin and placebo.","[{'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Ryan', 'Affiliation': ""From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL. elsdon.storey@monash.edu joanne.ryan@monash.edu.""}, {'ForeName': 'Elsdon', 'Initials': 'E', 'LastName': 'Storey', 'Affiliation': ""From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL. elsdon.storey@monash.edu joanne.ryan@monash.edu.""}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Murray', 'Affiliation': ""From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL.""}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Woods', 'Affiliation': ""From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL.""}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': ""From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL.""}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': ""From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL.""}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': ""From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL.""}, {'ForeName': 'Trevor T J', 'Initials': 'TTJ', 'LastName': 'Chong', 'Affiliation': ""From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL.""}, {'ForeName': 'Jeff D', 'Initials': 'JD', 'LastName': 'Williamson', 'Affiliation': ""From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL.""}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Ward', 'Affiliation': ""From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL.""}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Lockery', 'Affiliation': ""From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL.""}, {'ForeName': 'Suzanne G', 'Initials': 'SG', 'LastName': 'Orchard', 'Affiliation': ""From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL.""}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Trevaks', 'Affiliation': ""From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL.""}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Kirpach', 'Affiliation': ""From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL.""}, {'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Newman', 'Affiliation': ""From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL.""}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Ernst', 'Affiliation': ""From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL.""}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': ""From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL.""}, {'ForeName': 'Raj C', 'Initials': 'RC', 'LastName': 'Shah', 'Affiliation': ""From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology,['10.1212/WNL.0000000000009277'] 201,31860567,A Comparative Study on the Effects of High-Intensity Focused Electromagnetic Technology and Electrostimulation for the Treatment of Pelvic Floor Muscles and Urinary Incontinence in Parous Women: Analysis of Posttreatment Data.,"OBJECTIVES Pelvic floor muscles (PFMs) weakening and urinary incontinence (UI) represent health issues that have a negative impact on daily life. This study compares the immediate efficiency of high-intensity focused electromagnetic (HIFEM) therapy and electrostimulation for the treatment of weakened PFMs, accompanied by the UI. METHODS Ninety-five parous women were considered for the study. Symptomatic patients received either HIFEM or electrostimulation treatment. Treated patients completed 10 therapies scheduled 2 to 3 times per week (HIFEM) or every other day (electrostimulation). Patients underwent examination by 3-dimensional transperienal ultrasound at the baseline and posttreatments. Levator-urethra gap, anteroposterior diameter, laterolateral diameter of levator hiatus, and hiatal area were measured. In addition, Pelvic Floor Disability Index 20 questionnaire and subjective evaluation of patient's intimate health were assessed. RESULTS Enrolled patients were divided into group I (n = 50, HIFEM), group II (n = 25, electrostimulation), and group III (n = 20, control) according the indication and treatment modality. Three-dimensional ultrasounds showed positive changes in dynamics of the pelvic floor posttreatment (decreased anteroposterior diameter, laterolateral diameter, and hiatal area). However, the significant (P < 0.05) changes of pelvic floor integrity were observed only in group I. In addition, group I achieved greater level of improvement in Pelvic Floor Disability Index 20 questionnaire compared with group II (52% and 18% respectively; P < 0.001). Substantially fewer patients in group I reported urine leakage after treatments. CONCLUSIONS Posttreatment results suggest that HIFEM technology is suitable for treatment of PFMs weakening and showed to be more effective when compared with electrostimulation in short-term. Therefore, we recommend HIFEM as treatment option for weakened PFMs and UI.",2021,"Three-dimensional ultrasounds showed positive changes in dynamics of the pelvic floor posttreatment (decreased anteroposterior diameter, laterolateral diameter, and hiatal area).","['Parous Women', 'Ninety-five parous women were considered for the study']","['HIFEM', 'HIFEM or electrostimulation treatment', 'high-intensity focused electromagnetic (HIFEM) therapy and electrostimulation', 'High-Intensity Focused Electromagnetic Technology and Electrostimulation']","['Pelvic Floor Muscles and Urinary Incontinence', 'urine leakage', 'Levator-urethra gap, anteroposterior diameter, laterolateral diameter of levator hiatus, and hiatal area', 'pelvic floor integrity', 'pelvic floor posttreatment (decreased anteroposterior diameter, laterolateral diameter, and hiatal area', 'Pelvic Floor Disability Index 20 questionnaire', ""Pelvic Floor Disability Index 20 questionnaire and subjective evaluation of patient's intimate health""]","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C2729328', 'cui_str': 'Electromagnetic therapy'}, {'cui': 'C0013838', 'cui_str': 'Electromagnetics'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0042037'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C0041967', 'cui_str': 'Urethra'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0699756', 'cui_str': 'Intimate (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",95.0,0.0330277,"Three-dimensional ultrasounds showed positive changes in dynamics of the pelvic floor posttreatment (decreased anteroposterior diameter, laterolateral diameter, and hiatal area).","[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Silantyeva', 'Affiliation': 'From the Hospital Lapino MD Medical Group, Moscow, Russia.'}, {'ForeName': 'Dragana', 'Initials': 'D', 'LastName': 'Zarkovic', 'Affiliation': 'Charles University, Faculty of Physical Education and Sport, Department of Anatomy and Biomechanics, Prague, Czech Republic.'}, {'ForeName': 'Evgeniia', 'Initials': 'E', 'LastName': 'Astafeva', 'Affiliation': 'From the Hospital Lapino MD Medical Group, Moscow, Russia.'}, {'ForeName': 'Ramina', 'Initials': 'R', 'LastName': 'Soldatskaia', 'Affiliation': 'From the Hospital Lapino MD Medical Group, Moscow, Russia.'}, {'ForeName': 'Mekan', 'Initials': 'M', 'LastName': 'Orazov', 'Affiliation': 'RUDN University, Medical Faculty, Moscow, Russia.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Belkovskaya', 'Affiliation': 'From the Hospital Lapino MD Medical Group, Moscow, Russia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kurtser', 'Affiliation': 'From the Hospital Lapino MD Medical Group, Moscow, Russia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Female pelvic medicine & reconstructive surgery,['10.1097/SPV.0000000000000807'] 202,31331296,Polyhydramnios among women in a cluster-randomized trial of ultrasound during prenatal care within five low and low-middle income countries: a secondary analysis of the first look study.,"BACKGROUND In many low and low-middle income countries, the incidence of polyhydramnios is unknown, in part because ultrasound technology is not routinely used. Our objective was to report the incidence of polyhydramnios in five low and low-middle income countries, to determine maternal characteristics associated with polyhydramnios, and report pregnancy and neonatal outcomes. METHODS We performed a secondary analysis of the First Look Study, a multi-national, cluster-randomized trial of ultrasound during prenatal care. We evaluated all women enrolled from Guatemala, Pakistan, Zambia, Kenya and the Democratic Republic of Congo (DRC) who received an examination by prenatal ultrasound. We used pairwise site comparisons with Tukey-Kramer adjustment and multivariable logistic models with general estimating equations to control for cluster-level effects. The diagnosis of polyhydramnios was confrimed by an U.S. based radiologist in a majority of cases (62%). RESULTS We identified 305/18,640 (1.6%) cases of polyhydramnios. 229 (75%) cases were from the DRC, with an incidence of 10%. A higher percentage of women with polyhydramnios experienced obstructed labor (7% vs 4%) and fetal malposition (4% vs 2%). Neonatal death was more common when polyhydramnios was present (OR 2.43; CI 1.15, 5.13). CONCLUSIONS Polyhydramnios occured in these low and low-middle income countries at a rate similar to high-income contries except in the DRC where the incidence was 10%. Polyhydramnios was associated with obstructed labor, fetal malposition, and neonatal death. TRIAL REGISTRATION NCT01990625 , November 21, 2013.",2019,"Neonatal death was more common when polyhydramnios was present (OR 2.43; CI 1.15, 5.13). ","['women enrolled from Guatemala, Pakistan, Zambia, Kenya and the Democratic Republic of Congo (DRC) who received an examination by prenatal ultrasound', 'women in a cluster-randomized trial of ultrasound during prenatal care within five low and low-middle income countries']",[],"['fetal malposition', 'Neonatal death', 'obstructed labor', 'obstructed labor, fetal malposition, and neonatal death']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C0043445', 'cui_str': 'Republic of Zambia'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0043444', 'cui_str': 'Belgian Congo'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]",[],"[{'cui': 'C0269699', 'cui_str': 'Finding of malposition of fetus'}, {'cui': 'C0410916', 'cui_str': 'Neonatal Death'}, {'cui': 'C0549186', 'cui_str': 'Obstructed (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0152156', 'cui_str': 'Obstructed labor (finding)'}]",,0.127671,"Neonatal death was more common when polyhydramnios was present (OR 2.43; CI 1.15, 5.13). ","[{'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Bauserman', 'Affiliation': 'Department of Pediatrics, University of North Carolina School of Medicine, 101 Manning Drive, CB 7596, Chapel Hill, NC, 27599-7596, USA. Melissa_bauserman@med.unc.edu.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Nathan', 'Affiliation': 'Department of Radiology, Harborview Medical Center, University of Washington Medical Center, Seattle, WA, USA.'}, {'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Lokangaka', 'Affiliation': 'Kinshasa School of Public Health, Kinshasa, DRC, Republic of the Congo.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'McClure', 'Affiliation': 'RTI International, Durham, NC, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Moore', 'Affiliation': 'RTI International, Durham, NC, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ishoso', 'Affiliation': 'Kinshasa School of Public Health, Kinshasa, DRC, Republic of the Congo.'}, {'ForeName': 'Antoinette', 'Initials': 'A', 'LastName': 'Tshefu', 'Affiliation': 'Kinshasa School of Public Health, Kinshasa, DRC, Republic of the Congo.'}, {'ForeName': 'Lester', 'Initials': 'L', 'LastName': 'Figueroa', 'Affiliation': 'Fundación para la Alimentación y Nutrición de Centro América y Panamá (FANCAP), Guatemala City, Guatemala.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Garces', 'Affiliation': 'Fundación para la Alimentación y Nutrición de Centro América y Panamá (FANCAP), Guatemala City, Guatemala.'}, {'ForeName': 'Margo S', 'Initials': 'MS', 'LastName': 'Harrison', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado, Denver, CO, USA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Wallace', 'Affiliation': 'RTI International, Durham, NC, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Saleem', 'Affiliation': 'Department of Community Health Sciences, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Waseem', 'Initials': 'W', 'LastName': 'Mirza', 'Affiliation': 'Department of Pediatric Radiology, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Krebs', 'Affiliation': 'Department of Pediatrics, University of Colorado, Denver, CO, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hambidge', 'Affiliation': 'Department of Pediatrics, University of Colorado, Denver, CO, USA.'}, {'ForeName': 'Waldemar', 'Initials': 'W', 'LastName': 'Carlo', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Elwyn', 'Initials': 'E', 'LastName': 'Chomba', 'Affiliation': 'Department of Pediatrics, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Menachem', 'Initials': 'M', 'LastName': 'Miodovnik', 'Affiliation': 'Perinatology and Pregnancy Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, MD, USA.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Koso-Thomas', 'Affiliation': 'Perinatology and Pregnancy Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, MD, USA.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Liechty', 'Affiliation': 'Department of Pediatrics, Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Esamai', 'Affiliation': 'School of Medicine, Moi University, Eldoret, Kenya.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Swanson', 'Affiliation': ""Department of Radiology, Seattle Children's Hospital, University of Washington Medical Center, Seattle, WA, USA.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Swanson', 'Affiliation': 'Department of Radiology, University of Washington Medical Center, Seattle, WA, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Goldenberg', 'Affiliation': 'Department of Obstetrics/Gynecology, Columbia University, New York City, NY, USA.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Bose', 'Affiliation': 'Department of Pediatrics, University of North Carolina School of Medicine, 101 Manning Drive, CB 7596, Chapel Hill, NC, 27599-7596, USA.'}]",BMC pregnancy and childbirth,['10.1186/s12884-019-2412-6'] 203,32192678,TREAT AF (Transcutaneous Electrical Vagus Nerve Stimulation to Suppress Atrial Fibrillation): A Randomized Clinical Trial.,"OBJECTIVES This study was a sham-controlled, double-blind, randomized clinical trial to examine the effect of chronic low level tragus stimulation (LLTS) in patients with paroxysmal AF. BACKGROUND Low-level transcutaneous electrical stimulation of the auricular branch of the vagus nerve at the tragus (LLTS) acutely suppresses atrial fibrillation (AF) in humans, but the chronic effect remains unknown. METHODS LLTS (20 Hz, 1 mA below the discomfort threshold) was delivered using an ear clip attached to the tragus (active arm) (n = 26) or the ear lobe (sham control arm) (n = 27) for 1 h daily over 6 months. AF burden over 2-week periods was assessed by noninvasive continuous electrocardiogram monitoring at baseline, 3 months, and 6 months. Five-minute electrocardiography and serum were obtained at each visit to measure heart rate variability and inflammatory cytokines, respectively. RESULTS Baseline characteristics were balanced between the 2 groups. Adherence to the stimulation protocol (≤4 sessions lost per month) was 75% in the active arm and 83% in the control arm (p > 0.05). At 6 months, the median AF burden was 85% lower in the active arm compared with the control arm (ratio of medians: 0.15; 95% confidence interval: 0.03 to 0.65; p = 0.011). Tumor necrosis factor-alpha was significantly decreased by 23% in the active group relative to the control group (ratio of medians: 0.77; 95% confidence interval: 0.63 to 0.94; p = 0.0093). Frequency domain indices of heart rate variability were significantly altered with active versus control stimulation (p < 0.01). No device-related side effects were observed. CONCLUSIONS Chronic, intermittent LLTS resulted in lower AF burden than did sham control stimulation, supporting its use to treat paroxysmal AF in selected patients. (Transcutaneous Electrical Vagus Nerve Stimulation to Suppress Atrial Fibrillation [TREAT-AF]; NCT02548754).",2020,Frequency domain indices of heart rate variability were significantly altered with active versus control stimulation (p < 0.01).,"['LLTS', 'patients with paroxysmal AF', 'Suppress Atrial Fibrillation']","['chronic low level tragus stimulation (LLTS', 'Transcutaneous Electrical Vagus Nerve Stimulation', 'TREAT AF (Transcutaneous Electrical Vagus Nerve Stimulation to']","['Tumor necrosis factor-alpha', 'heart rate variability', 'median AF burden']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205311', 'cui_str': 'Paroxysmal (qualifier value)'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229312', 'cui_str': 'Tragus structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.436147,Frequency domain indices of heart rate variability were significantly altered with active versus control stimulation (p < 0.01).,"[{'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Stavrakis', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA. Electronic address: stavros-stavrakis@ouhsc.edu.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Stoner', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.'}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Humphrey', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.'}, {'ForeName': 'Lynsie', 'Initials': 'L', 'LastName': 'Morris', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Filiberti', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.'}, {'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'Reynolds', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Elkholey', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.'}, {'ForeName': 'Isma', 'Initials': 'I', 'LastName': 'Javed', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Twidale', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Riha', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.'}, {'ForeName': 'Subha', 'Initials': 'S', 'LastName': 'Varahan', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Scherlag', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.'}, {'ForeName': 'Warren M', 'Initials': 'WM', 'LastName': 'Jackman', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.'}, {'ForeName': 'Tarun W', 'Initials': 'TW', 'LastName': 'Dasari', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.'}, {'ForeName': 'Sunny S', 'Initials': 'SS', 'LastName': 'Po', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.'}]",JACC. Clinical electrophysiology,['10.1016/j.jacep.2019.11.008'] 204,32215674,"Effects of radial extracorporeal shock wave therapy on clinical variables and isokinetic performance in patients with knee osteoarthritis: a prospective, randomized, single-blind and controlled trial.","OBJECTIVE This study aims to compare the efficacy of r-ESWT treatment with sham-ESWT on pain, walking speed, physical function, and isokinetic muscle strength in knee osteoarthritis. METHODS The study included 104 patients (mean age 61.0 ± 6.2 years; range 50 to 70 years) who were admitted to our outpatient clinic with newly diagnosed with knee osteoarthritis. Patients were randomly assigned to two groups. Both groups received transcutaneous electrical nerve stimulation for 30 minutes, hot pack for 40 minutes, and home-based exercise program of around the knee strengthening for 30 minutes in a day for three weeks (5 days in a week). Also, one group was treated with r-ESWT, while the other group was treated with sham-ESWT. For r-ESWT, patients received 2000 pulses of shockwave at 2.0 to 3.0 bar weekly for three weeks. All patients were evaluated with visual analog scale (VAS), active knee range of motion (ROM), 20-metre walk test, Western Ontario and McMaster Osteoarthritis Index (WOMAC), Lequesne's disability index, and isokinetic muscle performance before treatment, at the end of treatment, at one month and three months after treatment. RESULTS When groups were compared, group 1 scores were significantly better than the group 2 in all outcome parameters except WOMAC-stiffness at the end of treatment, at one month and three month follow-up (all p < 0.05). The VAS-resting, VAS-movement, knee ROM, 20-m walk test, WOMAC, and Lequesne's disability scores and peak torque values of knee extension improved in both groups with the highest improvement in the r-ESWT group. A comparison of difference of the two group scores showed statistically significant superior improvement in group 1 in all parameters at both one month and three months. CONCLUSION Our findings revealed that r-ESWT combined with conventional electrotherapy is an effective treatment for improving pain and physical function in knee osteoarthritis to control symptoms up to three months. CLINICAL TRIALS ID NCT04243135.",2020,"A comparison of difference of the two group scores showed statistically significant superior improvement in group 1 in all parameters at both one month and three months. ","['knee osteoarthritis', 'patients with knee osteoarthritis', '104 patients (mean age 61.0\u2009±\u20096.2\xa0years; range 50 to 70\xa0years) who were admitted to our outpatient clinic with newly diagnosed with knee osteoarthritis']","['radial extracorporeal shock wave therapy', 'sham-ESWT', 'transcutaneous electrical nerve stimulation for 30\xa0minutes, hot pack for 40\xa0minutes, and home-based exercise program of around the knee strengthening', 'r-ESWT treatment with sham-ESWT', 'conventional electrotherapy']","['clinical variables and isokinetic performance', 'pain, walking speed, physical function, and isokinetic muscle strength', ""visual analog scale (VAS), active knee range of motion (ROM), 20-metre walk test, Western Ontario and McMaster Osteoarthritis Index (WOMAC), Lequesne's disability index, and isokinetic muscle performance"", ""VAS-resting, VAS-movement, knee ROM, 20-m walk test, WOMAC, and Lequesne's disability scores and peak torque values of knee extension"", 'pain and physical function', 'WOMAC-stiffness']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes (qualifier value)'}, {'cui': 'C0444519', 'cui_str': 'Hot sensation quality (qualifier value)'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0013787', 'cui_str': 'Electrical Stimulation Therapy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0576094', 'cui_str': 'Knee range of motion'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}]",104.0,0.0386954,"A comparison of difference of the two group scores showed statistically significant superior improvement in group 1 in all parameters at both one month and three months. ","[{'ForeName': 'Alper', 'Initials': 'A', 'LastName': 'Uysal', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Mustafa Kemal University Medical School, Hatay, Turkey.'}, {'ForeName': 'Mustafa Turgut', 'Initials': 'MT', 'LastName': 'Yildizgoren', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Mustafa Kemal University Medical School, Hatay, Turkey. ftr.mustafaturgut@hotmail.com.'}, {'ForeName': 'Hayal', 'Initials': 'H', 'LastName': 'Guler', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Mustafa Kemal University Medical School, Hatay, Turkey.'}, {'ForeName': 'Ayse Dicle', 'Initials': 'AD', 'LastName': 'Turhanoglu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Mustafa Kemal University Medical School, Hatay, Turkey.'}]",International orthopaedics,['10.1007/s00264-020-04541-w'] 205,32211778,A laboratory study on the effects of wind turbine noise on sleep: results of the polysomnographic WiTNES study.,"STUDY OBJECTIVES Assess the physiologic and self-reported effects of wind turbine noise (WTN) on sleep. METHODS Laboratory sleep study (n = 50 participants: n = 24 living close to wind turbines and n = 26 as a reference group) using polysomnography, electrocardiography, salivary cortisol, and questionnaire endpoints. Three consecutive nights (23:00-07:00): one habituation followed by a randomized quiet Control and an intervention night with synthesized 32 dB LAEq WTN. Noise in WTN nights simulated closed and ajar windows and low and high amplitude modulation depth. RESULTS There was a longer rapid eye movement (REM) sleep latency (+16.8 min) and lower amount of REM sleep (-11.1 min, -2.2%) in WTN nights. Other measures of objective sleep did not differ significantly between nights, including key indicators of sleep disturbance (sleep efficiency: Control 86.6%, WTN 84.2%; wakefulness after sleep onset: Control 45.2 min, WTN 52.3 min; awakenings: Control n = 11.4, WTN n = 11.5) or the cortisol awakening response. Self-reported sleep was consistently rated as worse following WTN nights, and individuals living close to wind turbines had worse self-reported sleep in both the Control and WTN nights than the reference group. CONCLUSIONS Amplitude-modulated continuous WTN may impact on self-assessed and some aspects of physiologic sleep. Future studies are needed to generalize these findings outside of the laboratory and should include more exposure nights and further examine possible habituation or sensitization.",2020,"Other measures of objective sleep did not differ significantly between nights, including key indicators of sleep disturbance (sleep efficiency: Control 86.6%, WTN 84.2%; wakefulness after sleep onset: Control 45.2 min, WTN 52.3 min; awakenings: Control n=11.4, WTN n=11.5) or the cortisol awakening response.","['n=24 living close to wind turbines, n=26 as a reference group) using', 'Laboratory sleep study (n=50 participants']","['wind turbine noise (WTN', 'wind turbine noise', 'habituation followed by a randomized quiet Control and an intervention night with synthesized 32 dB LAEq WTN']","['Self-reported sleep', 'longer REM sleep latency', 'objective sleep', 'sleep disturbance (sleep efficiency', 'REM sleep', 'polysomnography, electrocardiography, salivary cortisol and questionnaire endpoints', 'sleep', 'cortisol awakening response']","[{'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C0043187', 'cui_str': 'Wind'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}]","[{'cui': 'C0043187', 'cui_str': 'Wind'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0013170', 'cui_str': 'Drug habituation (disorder)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439654', 'cui_str': 'Quiet (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0037322', 'cui_str': 'Sleep, Fast-Wave'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}]",50.0,0.0184545,"Other measures of objective sleep did not differ significantly between nights, including key indicators of sleep disturbance (sleep efficiency: Control 86.6%, WTN 84.2%; wakefulness after sleep onset: Control 45.2 min, WTN 52.3 min; awakenings: Control n=11.4, WTN n=11.5) or the cortisol awakening response.","[{'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Smith', 'Affiliation': 'Department of Occupational and Environmental Medicine, School of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Ögren', 'Affiliation': 'Department of Occupational and Environmental Medicine, School of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Pontus', 'Initials': 'P', 'LastName': 'Thorsson', 'Affiliation': 'Division of Applied Acoustics, Department of Civil and Environmental Engineering, Chalmers University of Technology, Gothenburg, Sweden.'}, {'ForeName': 'Laith', 'Initials': 'L', 'LastName': 'Hussain-Alkhateeb', 'Affiliation': 'Department of Occupational and Environmental Medicine, School of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Eja', 'Initials': 'E', 'LastName': 'Pedersen', 'Affiliation': 'Department of Architecture and the Built Environment, Lund University, Lund, Sweden.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Forssén', 'Affiliation': 'Division of Applied Acoustics, Department of Civil and Environmental Engineering, Chalmers University of Technology, Gothenburg, Sweden.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Ageborg Morsing', 'Affiliation': 'Department of Occupational and Environmental Medicine, School of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Persson Waye', 'Affiliation': 'Department of Occupational and Environmental Medicine, School of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",Sleep,['10.1093/sleep/zsaa046'] 206,29782696,Routine antenatal ultrasound in low- and middle-income countries: first look - a cluster randomised trial.,"OBJECTIVE Ultrasound is widely regarded as an important adjunct to antenatal care (ANC) to guide practice and reduce perinatal mortality. We assessed the impact of ANC ultrasound use at health centres in resource-limited countries. DESIGN Cluster randomised trial. SETTING Clusters within five countries (Democratic Republic of Congo, Guatemala, Kenya, Pakistan, and Zambia) METHODS: Clusters were randomised to standard ANC or standard care plus two ultrasounds and referral for complications. The study trained providers in intervention clusters to perform basic obstetric ultrasounds. MAIN OUTCOME MEASURES The primary outcome was a composite of maternal mortality, maternal near-miss mortality, stillbirth, and neonatal mortality. RESULTS During the 24-month trial, 28 intervention and 28 control clusters had 24 263 and 23 160 births, respectively; 78% in the intervention clusters received at least one study ultrasound; 60% received two. The prevalence of conditions noted including twins, placenta previa, and abnormal lie was within expected ranges. 9% were referred for an ultrasound-diagnosed condition, and 71% attended the referral. The ANC (RR 1.0 95% CI 1.00, 1.01) and hospital delivery rates for complicated pregnancies (RR 1.03 95% CI 0.89, 1.20) did not differ between intervention and control clusters nor did the composite outcome (RR 1.09 95% CI 0.97, 1.23) or its individual components. CONCLUSIONS Despite availability of ultrasound at ANC in the intervention clusters, neither ANC nor hospital delivery for complicated pregnancies increased. The composite outcome and the individual components were not reduced. TWEETABLE ABSTRACT Antenatal care ultrasound did not improve a composite outcome that included maternal, fetal, and neonatal mortality.",2018,"The ANC (RR 1.0 95% CI 1.00, 1.01) and hospital delivery rates for complicated pregnancies (RR 1.03 95% CI 0.89, 1.20) did not differ between intervention and control clusters nor did the composite outcome (RR 1.09 95% CI 0.97, 1.23) or its individual components. ","['Clusters within five countries (Democratic Republic of Congo, Guatemala, Kenya, Pakistan, and Zambia']","['standard ANC or standard care plus two ultrasounds and referral for complications', 'Routine antenatal ultrasound']","['hospital delivery rates', 'prevalence of conditions noted including twins, placenta previa, and abnormal lie', 'composite of maternal mortality, maternal near-miss mortality, stillbirth, and neonatal mortality']","[{'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0043444', 'cui_str': 'Belgian Congo'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C0043445', 'cui_str': 'Republic of Zambia'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C2585524', 'cui_str': 'Referral for'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}]","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0032046', 'cui_str': 'Placenta Previa'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0600261', 'cui_str': 'Lying'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0024923', 'cui_str': 'Maternal Mortality'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}]",9.0,0.213579,"The ANC (RR 1.0 95% CI 1.00, 1.01) and hospital delivery rates for complicated pregnancies (RR 1.03 95% CI 0.89, 1.20) did not differ between intervention and control clusters nor did the composite outcome (RR 1.09 95% CI 0.97, 1.23) or its individual components. ","[{'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Goldenberg', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'R O', 'Initials': 'RO', 'LastName': 'Nathan', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Swanson', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Saleem', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Mirza', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Esamai', 'Affiliation': 'Moi University, Eldoret, Kenya.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Muyodi', 'Affiliation': 'Moi University, Eldoret, Kenya.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Garces', 'Affiliation': 'INCAP, Guatemala City, Guatemala.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Figueroa', 'Affiliation': 'INCAP, Guatemala City, Guatemala.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Chomba', 'Affiliation': 'University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Chiwala', 'Affiliation': 'University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mwenechanya', 'Affiliation': 'University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tshefu', 'Affiliation': 'Kinshasa School of Public Health, Kinshasa, DRC.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lokangako', 'Affiliation': 'Kinshasa School of Public Health, Kinshasa, DRC.'}, {'ForeName': 'V L', 'Initials': 'VL', 'LastName': 'Bolamba', 'Affiliation': 'Kinshasa School of Public Health, Kinshasa, DRC.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Moore', 'Affiliation': 'RTI International, Durham, NC, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Franklin', 'Affiliation': 'RTI International, Durham, NC, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Swanson', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Liechty', 'Affiliation': 'Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Bose', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'N F', 'Initials': 'NF', 'LastName': 'Krebs', 'Affiliation': 'University of Colorado, Denver, CO, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Michael Hambidge', 'Affiliation': 'University of Colorado, Denver, CO, USA.'}, {'ForeName': 'W A', 'Initials': 'WA', 'LastName': 'Carlo', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Kanaiza', 'Affiliation': 'Moi University, Eldoret, Kenya.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Naqvi', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'I S', 'Initials': 'IS', 'LastName': 'Pineda', 'Affiliation': 'San Carlos University, Guatemala City, Guatemala.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'López-Gomez', 'Affiliation': 'NICHD, Bethesda, MD, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Hamsumonde', 'Affiliation': 'University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Harrison', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Koso-Thomas', 'Affiliation': 'NICHD, Bethesda, MD, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Miodovnik', 'Affiliation': 'NICHD, Bethesda, MD, USA.'}, {'ForeName': 'D D', 'Initials': 'DD', 'LastName': 'Wallace', 'Affiliation': 'RTI International, Durham, NC, USA.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'McClure', 'Affiliation': 'RTI International, Durham, NC, USA.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.15287'] 207,31907645,"A randomized, double-blind, single-dose study to evaluate the biosimilarity of QL1101 with bevacizumab in healthy male subjects.","PURPOSE This is the first study to compare the pharmacokinetics of QL1101, a proposed bevacizumab biosimilar, with Avastin ® sourced from Roche Diagnostics GmbH. METHODS In this double-blind, single-dose, parallel-group study, healthy male subjects were randomized 1:1 to receive QL1101 or Avastin ® 3 mg/kg intravenously. Pharmacokinetic assessments were conducted for 85 days, with additional safety and immunogenicity assessments until day 90. Primary study endpoints were area under the concentration-time curve (AUC) from time zero to infinity (AUC 0-∞ ), AUC from time zero to the last quantifiable concentration (AUC 0-last ), and maximum serum concentration (C max ). Pharmacokinetic equivalence was shown if the 90% confidence intervals (CIs) of the geometric mean ratios (GMRs) of the C 0-max , AUC 0-last , and AUC 0-∞ were within the predefined bioequivalence margin of 80-125.00%. RESULTS A total of 82 subjects were randomized to the following groups: 42 to QL1101 and 40 to Avastin ® . The 90% CIs of the GMRs of AUC 0-∞ , AUC 0-last , and C max of QL1101 and Avastin® were (97.8%, 107.0%), (94.5%, 106.9%), and (94.1%, 107.3%), respectively, which were all within the bioequivalence margin. The incidence of adverse events was 90.5% and 95.0% in the QL1101 and Avastin® groups, respectively. Mean serum concentration-time profiles, secondary pharmacokinetic parameters, and safety and immunogenicity profiles were comparable across the two treatment groups. CONCLUSIONS The study demonstrated the pharmacokinetic equivalence of QL1101 to Avastin ® . QL1101 (3 mg/kg, iv) is safe and tolerable in healthy Chinese subjects. These data support the further clinical evaluation of QL1101 as a bevacizumab biosimilar.",2020,"Mean serum concentration-time profiles, secondary pharmacokinetic parameters, and safety and immunogenicity profiles were comparable across the two treatment groups. ","['healthy male subjects', 'healthy Chinese subjects', '82 subjects']","['QL1101 or Avastin ® 3\xa0mg/kg intravenously', 'QL1101 to Avastin ® ', 'QL1101 and 40 to Avastin ® ', 'QL1101 with bevacizumab', 'QL1101']","['Pharmacokinetic equivalence', 'Mean serum concentration-time profiles, secondary pharmacokinetic parameters, and safety and immunogenicity profiles', 'area under the concentration-time curve (AUC) from time zero to infinity (AUC 0-∞ ), AUC from time zero to the last quantifiable concentration (AUC 0-last ), and maximum serum concentration (C max ', 'incidence of adverse events', 'geometric mean ratios (GMRs) of the C 0-max , AUC 0-last , and AUC 0-∞', 'GMRs of AUC 0-∞ , AUC 0-last , and C max of QL1101 and Avastin®', 'safe and tolerable']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C1135130', 'cui_str': 'Avastin'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1135130', 'cui_str': 'Avastin'}]",82.0,0.110872,"Mean serum concentration-time profiles, secondary pharmacokinetic parameters, and safety and immunogenicity profiles were comparable across the two treatment groups. ","[{'ForeName': 'Ya-Nan', 'Initials': 'YN', 'LastName': 'Liu', 'Affiliation': 'Clinical Trails Center of the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Clinical Trails Center of the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Guo', 'Affiliation': 'Clinical Trails Center of the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Clinical Trails Center of the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Ye', 'Affiliation': 'Clinical Trails Center of the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Shu-Ting', 'Initials': 'ST', 'LastName': 'Wu', 'Affiliation': 'Clinical Trails Center of the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xing-Fei', 'Initials': 'XF', 'LastName': 'Zhang', 'Affiliation': 'Clinical Trails Center of the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Yang', 'Affiliation': 'Clinical Trails Center of the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Cui-Cui', 'Initials': 'CC', 'LastName': 'Han', 'Affiliation': 'Qilu Pharmaceutical Co. Ltd, Jinan, Shangdong, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Pei', 'Affiliation': 'Department of Pharmacy of the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Pharmacy of the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Qing-Nan', 'Initials': 'QN', 'LastName': 'He', 'Affiliation': 'Research Center for Drug Clinical Evaluation, Central South University, Changsha, Hunan, China. heqn2629@163.com.'}, {'ForeName': 'Guo-Ping', 'Initials': 'GP', 'LastName': 'Yang', 'Affiliation': 'Clinical Trails Center of the Third Xiangya Hospital, Central South University, Changsha, Hunan, China. ygp9880@126.com.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-019-04014-x'] 208,32211907,Prevention of Macular Edema in Patients With Diabetic Retinopathy Undergoing Cataract Surgery: The PROMISE Trial.,"BACKGROUND AND OBJECTIVE To determine the safety and efficacy of intravitreal aflibercept injection (IAI) in patients with diabetic retinopathy (DR) in the prevention of macular edema (ME) following cataract surgery. PATIENTS AND METHODS This phase 2, prospective, interventional, single-masked, randomized trial at a single academic center included 30 patients who were 18 years of age or older with nonproliferative DR and undergoing cataract surgery with phacoemulsification. Patients received 2 mg intravitreal aflibercept (0.05 mL) or sham injection during cataract surgery. Main outcome measures included treatment adverse events (AEs), best-corrected visual acuity (BCVA), and incidence of ME (defined as presence of cystoid abnormalities as detected by optical coherence tomography at any follow-up visit), a 30% or greater increase from preoperative baseline in central subfield macular thickness, or a BCVA decrease of more than 5 ETDRS letters from Day 7 due to retinal thickening. RESULTS There were similar incidences of AEs between the two groups and no clinically serious ocular AEs in either group. The IAI group had fewer ME events at Day 14 (13% vs. 53%; P = .022), but there was no significant difference in ME events at Day 30 (27% vs. 60%; P = .057), Day 60 (27% vs. 60%; P = .057), or Day 90 (40% vs. 67%; P = .161). Compared to the study group, the control group had a significantly greater increase in central subfield thickness (CST) at Day 30 (50.05 μm vs. 7.95 μm; P = .040) and Day 60 (56.45 μm vs. 3.02 μm; P = .010). However, the difference in CST between groups was no longer significant at Day 90 (50.31 μm vs. 18.48 μm; P = .12). There were no significant differences in BCVA gains between the IAI and sham group at the end of the follow-up period (Day 90, ETDRS letters: 9.88 vs. 8.52; P = .66). CONCLUSIONS Use of IAI in patients with DR for prevention of ME following cataract surgery showed no significant AEs. Although there were significant differences in ME incidence and retinal thickness at periods of time, there was no clinically meaningful benefit in terms of VA. Further larger trials are needed to validate these findings. [Ophthalmic Surg Lasers Imaging Retina. 2020;51:170-178.].",2020,"The IAI group had fewer ME events at Day 14 (13% vs. 53%; P = .022), but there was no significant difference in ME events at Day 30 (27% vs. 60%; P = .057), Day 60 (27% vs. 60%; P = .057), or Day 90 (40% vs. 67%; P = .161).","['30 patients who were 18 years of age or older with nonproliferative DR and undergoing cataract surgery with phacoemulsification', 'Patients With Diabetic Retinopathy Undergoing Cataract Surgery', 'patients with diabetic retinopathy (DR']","['intravitreal aflibercept', 'intravitreal aflibercept injection (IAI']","['treatment adverse events (AEs), best-corrected visual acuity (BCVA), and incidence of ME (defined as presence of cystoid abnormalities', 'ME incidence and retinal thickness', 'preoperative baseline in central subfield macular thickness, or a BCVA decrease of more than 5 ETDRS letters', 'safety and efficacy', 'BCVA gains', 'central subfield thickness (CST', 'ME events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}]","[{'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0560172', 'cui_str': 'cSt'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",,0.121642,"The IAI group had fewer ME events at Day 14 (13% vs. 53%; P = .022), but there was no significant difference in ME events at Day 30 (27% vs. 60%; P = .057), Day 60 (27% vs. 60%; P = .057), or Day 90 (40% vs. 67%; P = .161).","[{'ForeName': 'Weilin', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Thais F', 'Initials': 'TF', 'LastName': 'Conti', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gans', 'Affiliation': ''}, {'ForeName': 'Felipe F', 'Initials': 'FF', 'LastName': 'Conti', 'Affiliation': ''}, {'ForeName': 'Fabiana Q', 'Initials': 'FQ', 'LastName': 'Silva', 'Affiliation': ''}, {'ForeName': 'Namrata', 'Initials': 'N', 'LastName': 'Saroj', 'Affiliation': ''}, {'ForeName': 'Rishi P', 'Initials': 'RP', 'LastName': 'Singh', 'Affiliation': ''}]","Ophthalmic surgery, lasers & imaging retina",['10.3928/23258160-20200228-06'] 209,32211908,Functional and Morphologic Findings at Four Years After Intravitreal Bevacizumab or Laser for Type 1 ROP.,"BACKGROUND AND OBJECTIVE To compare morphologic and functional status at age 4 years for patients treated in one eye with laser photocoagulation and the other eye with intravitreal bevacizumab (IVB) injection for Type 1 retinopathy of prematurity (ROP). PATIENTS AND METHODS In this single-center, randomized, controlled trial, best-corrected visual acuity (BCVA) in logMAR was obtained along with spherical equivalent refraction (SER), fluorescein angiography (FA), optical coherent tomography (OCT), and OCT angiography (OCTA). RESULTS Eighteen babies (36 eyes) were selected for this study. BCVA and SER were similar in the two groups, but six patients had anisometropia of 4 diopters or more. IVB-treated eyes tended to have thinner foveal thickness than laser-treated eyes (mean difference: -5.33 pixels; 95% confidence interval, -9.62 to -1.05). CONCLUSION Although the differences found here are minimal between the IVB-treated and laser-treated groups, further long-term evaluation of not only FA, but also OCT and OCTA, are needed in larger studies. [Ophthalmic Surg Lasers Imaging Retina. 2020;51:180-186.].",2020,IVB-treated eyes tended to have thinner foveal thickness than laser-treated eyes (mean difference:,['Eighteen babies (36 eyes'],"['Intravitreal Bevacizumab', 'BCVA', 'laser photocoagulation and the other eye with intravitreal bevacizumab (IVB) injection']","['spherical equivalent refraction (SER), fluorescein angiography (FA), optical coherent tomography (OCT), and OCT angiography (OCTA', 'thinner foveal thickness']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0023694', 'cui_str': 'Photocoagulation'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C4033858', 'cui_str': 'bevacizumab Injection [Avastin]'}]","[{'cui': 'C0332501', 'cui_str': 'Spherical shape (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0430943', 'cui_str': 'Refraction'}, {'cui': 'C0016313', 'cui_str': 'Fluorescein Angiography'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}]",,0.067992,IVB-treated eyes tended to have thinner foveal thickness than laser-treated eyes (mean difference:,"[{'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Lepore', 'Affiliation': ''}, {'ForeName': 'Marco H', 'Initials': 'MH', 'LastName': 'Ji', 'Affiliation': ''}, {'ForeName': 'Graham E', 'Initials': 'GE', 'LastName': 'Quinn', 'Affiliation': ''}, {'ForeName': 'Giulia M', 'Initials': 'GM', 'LastName': 'Amorelli', 'Affiliation': ''}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Orazi', 'Affiliation': ''}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Ricci', 'Affiliation': ''}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Mercuri', 'Affiliation': ''}]","Ophthalmic surgery, lasers & imaging retina",['10.3928/23258160-20200228-07'] 210,29601076,"Syncope, Hypotension, and Falls in the Treatment of Hypertension: Results from the Randomized Clinical Systolic Blood Pressure Intervention Trial.","OBJECTIVE To determine predictors of serious adverse events (SAEs) involving syncope, hypotension, and falls, with particular attention to age, in the Systolic Blood Pressure Intervention Trial. DESIGN Randomized clinical trial. SETTING Academic and private practices across the United States (N = 102). PARTICIPANTS Adults aged 50 and older with a systolic blood pressure (SBP) of 130 to 180 mmHg at high risk of cardiovascular disease events, but without diabetes, history of stroke, symptomatic heart failure or ejection fraction less than 35%, dementia, or standing SBP less than 110 mmHg (N = 9,361). INTERVENTION Treatment of SBP to a goal of less than 120 mmHg or 140 mmHg. MEASUREMENTS Outcomes were SAEs involving syncope, hypotension, and falls. Predictors were treatment assignment, demographic characteristics, comorbidities, baseline measurements, and baseline use of cardiovascular medications. RESULTS One hundred seventy-two (1.8%) participants had SAEs involving syncope, 155 (1.6%) hypotension, and 203 (2.2%) falls. Randomization to intensive SBP control was associated with greater risk of an SAE involving hypotension (hazard ratio (HR) = 1.67, 95% confidence interval (CI) = 1.21-2.32, P = .002), and possibly syncope (HR = 1.32, 95% CI = 0.98-1.79, P = .07), but not falls (HR = 0.98, 95% CI = 0.75-1.29, P = .90). Risk of all three outcomes was higher for participants with chronic kidney disease or frailty. Older age was also associated with greater risk of syncope, hypotension, and falls, but there was no age-by-treatment interaction for any of the SAE outcomes. CONCLUSIONS Participants randomized to intensive SBP control had greater risk of hypotension and possibly syncope, but not falls. The greater risk of developing these events associated with intensive treatment did not vary according to age.",2018,"Randomization to intensive SBP control was associated with greater risk of an SAE involving hypotension (hazard ratio (HR) = 1.67, 95% confidence interval (CI) = ","['Academic and private practices across the United States (N\xa0=\xa0102', 'One hundred seventy-two (1.8%) participants had SAEs involving syncope, 155 (1.6%) hypotension, and 203 (2.2%) falls', 'Adults aged 50 and older with a systolic blood pressure (SBP) of 130 to 180\xa0mmHg at high risk of cardiovascular disease events, but without diabetes, history of stroke, symptomatic heart failure or ejection fraction less than 35%, dementia, or standing SBP less than 110', 'participants with chronic kidney disease or frailty']",['intensive SBP control'],"['greater risk of an SAE involving hypotension', 'risk of hypotension and possibly syncope', 'possibly syncope', 'risk of syncope, hypotension, and falls', 'SAEs involving syncope, hypotension, and falls', 'Syncope, Hypotension, and Falls', 'demographic characteristics, comorbidities, baseline measurements, and baseline use of cardiovascular medications']","[{'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C4517508', 'cui_str': '1.6 (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}]","[{'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C2362652', 'cui_str': 'Possible diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}]",,0.14687,"Randomization to intensive SBP control was associated with greater risk of an SAE involving hypotension (hazard ratio (HR) = 1.67, 95% confidence interval (CI) = ","[{'ForeName': 'Kaycee M', 'Initials': 'KM', 'LastName': 'Sink', 'Affiliation': 'Department of Medicine, Section on Department of Geriatric Medicine, School of Medicine, Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'Gregory W', 'Initials': 'GW', 'LastName': 'Evans', 'Affiliation': 'Division of Public Health Sciences, School of Medicine, Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'Ronald I', 'Initials': 'RI', 'LastName': 'Shorr', 'Affiliation': 'Malcom Randall Veterans Affairs Medical Center, Gainesville, Florida.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Bates', 'Affiliation': 'Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Berlowitz', 'Affiliation': 'Bedford Veterans Affairs Hospital, Bedford, Massachusetts.'}, {'ForeName': 'Molly B', 'Initials': 'MB', 'LastName': 'Conroy', 'Affiliation': 'Division of General Internal Medicine, School of Medicine, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Deborah M', 'Initials': 'DM', 'LastName': 'Felton', 'Affiliation': 'Division of Public Health Sciences, School of Medicine, Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Gure', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Wexner Medical Center, Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, Tennessee.'}, {'ForeName': 'Dalane', 'Initials': 'D', 'LastName': 'Kitzman', 'Affiliation': 'Department of Cardiology, School of Medicine, Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'Mary F', 'Initials': 'MF', 'LastName': 'Lyles', 'Affiliation': 'Department of Medicine, Section on Department of Geriatric Medicine, School of Medicine, Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Servilla', 'Affiliation': 'Renal Section, New Mexico VA Health Care System, Albuquerque, New Mexico.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Supiano', 'Affiliation': 'Division of Geriatrics, School of Medicine, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Whittle', 'Affiliation': 'Primary Care Division, Clement J. Zablocki Veterans Affairs Medical Center, Milwaukee, Wisconsin.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Wiggers', 'Affiliation': 'Department of Primary Care, Heritage College of Osteopathic Medicine, Ohio University Cleveland Campus, Cleveland, Ohio.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Fine', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.15236'] 211,32209605,Adenoma detection by Endocuff-assisted versus standard colonoscopy in routine practice: a cluster-randomised crossover trial.,"OBJECTIVE Endocuff Vision (ECV) is the second generation of a device designed to improve polyp detection. The aim of this study was to evaluate its impact on adenoma detection rate (ADR) in routine colonoscopy. DESIGN This cluster-randomised crossover trial compared Endocuff-assisted (ECV+) with standard (ECV-) colonoscopy. Two teams of 11 endoscopists each with prior ECV experience, balanced in terms of basal ADR, gender and case volume were compared. In randomised fashion, the teams started with ECV+ or ECV- and switched group after inclusion of half of the cases. The main outcome criterion was ADR difference between ECV+ and ECV-. Subgroup analysis was done for physicians with low and high ADR (< or ≥ 25%). RESULTS During two periods of 20 and 21 weeks, respectively, the 22 endoscopists included 2058 patients (1032 ECV- vs 1026 ECV+, both groups being comparable). Overall ADR for both groups taken together was higher with ECV (39.2%) than without (29.4%; p<0.001) irrespective of the sequence of use (ECV+ or ECV- first), but mostly in adenomas <1 cm. In the physician subgroup analysis, only high detectors showed a significant ADR increase (from 31% to 41%, p<0.001), while the increase in the low detectors was not significant (from 24% to 30%, p=0.11). ECV had a positive impact in all colonic locations, except for the rectum. No ECV- related complication was reported. CONCLUSION We observed a significant ADR difference of approximately 10% by the use of ECV. By subgroup analysis, this increase was significant only in physicians classified as high detectors. TRIAL REGISTRATION NUMBER ClinicalTrials.gov (NCT03344055).",2020,"Overall ADR for both groups taken together was higher with ECV (39.2%) than without (29.4%; p<0.001) irrespective of the sequence of use (ECV+ or ECV- first), but mostly in adenomas <1 cm.",[],"['Endocuff-assisted (ECV+) with standard (ECV-) colonoscopy', 'ECV', 'ECV+ or ECV', 'Endocuff-assisted versus standard colonoscopy']","['ADR difference between ECV+ and ECV', 'Overall ADR', 'low detectors', 'adenoma detection rate (ADR']",[],"[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]","[{'cui': 'C0449207', 'cui_str': 'ADR (body structure)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}]",2058.0,0.204169,"Overall ADR for both groups taken together was higher with ECV (39.2%) than without (29.4%; p<0.001) irrespective of the sequence of use (ECV+ or ECV- first), but mostly in adenomas <1 cm.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Karsenti', 'Affiliation': 'Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France karsenti@club-internet.fr.'}, {'ForeName': 'Gaelle', 'Initials': 'G', 'LastName': 'Tharsis', 'Affiliation': 'Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France.'}, {'ForeName': 'Bastien', 'Initials': 'B', 'LastName': 'Perrot', 'Affiliation': 'Methodology Unit, UMR INSERM 1246 SPHERE, Université de Nantes, Université de Tours, Institut de Recherche en Santé (IRS2), Universite de Nantes, Nantes, Pays de la Loire, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Cattan', 'Affiliation': 'Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Tordjman', 'Affiliation': 'Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Venezia', 'Affiliation': 'Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France.'}, {'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'Zrihen', 'Affiliation': 'Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Gillot', 'Affiliation': 'Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Gillet', 'Affiliation': 'Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Hagege', 'Affiliation': 'Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France.'}, {'ForeName': 'Joelle', 'Initials': 'J', 'LastName': 'Samama', 'Affiliation': 'Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Etienney', 'Affiliation': 'Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Lab', 'Affiliation': 'Private Pathology Institute, Rue de Wattignies, Paris, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Guigui', 'Affiliation': 'Private Pathology Institute, Rue de Wattignies, Paris, France.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Zago', 'Affiliation': 'Private Pathology Institute, Rue du Colisée, Paris, France.'}, {'ForeName': 'Bouchra', 'Initials': 'B', 'LastName': 'Benkessou', 'Affiliation': 'Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Burtin', 'Affiliation': 'Digestive Oncology, Insitut Gustave Roussy, Villejuif, Île-de-France, France.'}, {'ForeName': 'Maryan', 'Initials': 'M', 'LastName': 'Cavicchi', 'Affiliation': 'Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France.'}]",Gut,['10.1136/gutjnl-2019-319565'] 212,32209625,"G-CSF (filgrastim) treatment for amyotrophic lateral sclerosis: protocol for a phase II randomised, double-blind, placebo-controlled, parallel group, multicentre clinical study (STEMALS-II trial).","INTRODUCTION Amyotrophic lateral sclerosis (ALS) is a fatal progressive neurological disorder characterised by a selective degeneration of motor neurons (MNs). Stem cell transplantation is considered as a promising strategy in neurological disorders therapy and the possibility of inducing bone marrow cells (BMCs) to circulate in the peripheral blood is suggested to investigate stem cells migration in degenerated ALS nerve tissues where potentially repair MN damage. Granulocyte-colony stimulating factor (G-CSF) is a growth factor which stimulates haematopoietic progenitor cells, mobilises BMCs into injured brain and it is itself a neurotrophic factor for MN. G-CSF safety in humans has been demonstrated and many observations suggest that it may affect neural cells. Therefore, we decided to use G-CSF to mobilise BMCs into the peripheral circulation in patients with ALS, planning a clinical trial to evaluate the effect of G-CSF administration in ALS patients compared with placebo. METHODS AND ANALYSIS STEMALS-II is a phase II multicentre, randomised double-blind, placebo-controlled, parallel group clinical trial on G-CSF (filgrastim) and mannitol in ALS patients. Specifically, we investigate safety, tolerability and efficacy of four repeated courses of intravenous G-CSF and mannitol administered in 76 ALS patients in comparison with placebo (indistinguishable glucose solution 5%). We determine increase of G-CSF levels in serum and cerebrospinal fluid as CD34 + cells and leucocyte count after treatment; reduction in ALS Functional Rating Scale-Revised Score, forced vital capacity, Scale for Testing Muscle Strength Score and quality of life; the adverse events/reactions during the treatment; changes in neuroinflammation biomarkers before and after treatment. ETHICS AND DISSEMINATION The study protocol was approved by the Ethics Committee of Azienda Ospedaliera Universitaria 'Città della Salute e della Scienza', Torino, Italy. Results will be presented during scientific symposia or published in scientific journals. TRIAL REGISTRATION NUMBER Eudract 2014-002228-28.",2020,"We determine increase of G-CSF levels in serum and cerebrospinal fluid as CD34 + cells and leucocyte count after treatment; reduction in ALS Functional Rating Scale-Revised Score, forced vital capacity, Scale for Testing Muscle Strength Score and quality of life; the adverse events/reactions during the treatment; changes in neuroinflammation biomarkers before and after treatment. ","['76 ALS patients in comparison with placebo (indistinguishable glucose solution 5', 'ALS patients', 'amyotrophic lateral sclerosis']","['G-CSF (filgrastim', 'placebo', 'intravenous G-CSF and mannitol', 'G-CSF (filgrastim) and mannitol', 'Granulocyte-colony stimulating factor (G-CSF', 'Stem cell transplantation']","['ALS Functional Rating Scale-Revised Score, forced vital capacity, Scale for Testing Muscle Strength Score and quality of life', 'G-CSF levels', 'safety, tolerability and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0002736', 'cui_str': 'ALS (Amyotrophic Lateral Sclerosis)'}]","[{'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0887166', 'cui_str': '(L)-Mannitol'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0034380'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",76.0,0.346543,"We determine increase of G-CSF levels in serum and cerebrospinal fluid as CD34 + cells and leucocyte count after treatment; reduction in ALS Functional Rating Scale-Revised Score, forced vital capacity, Scale for Testing Muscle Strength Score and quality of life; the adverse events/reactions during the treatment; changes in neuroinflammation biomarkers before and after treatment. ","[{'ForeName': 'Paolina', 'Initials': 'P', 'LastName': 'Salamone', 'Affiliation': ""'Rita Levi Montalcini' Department of Neuroscience, University of Turin, Torino, Piemonte, Italy.""}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Fuda', 'Affiliation': ""'Rita Levi Montalcini' Department of Neuroscience, University of Turin, Torino, Piemonte, Italy.""}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Casale', 'Affiliation': ""'Rita Levi Montalcini' Department of Neuroscience, University of Turin, Torino, Piemonte, Italy federico.casale@unito.it.""}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Marrali', 'Affiliation': ""'Rita Levi Montalcini' Department of Neuroscience, University of Turin, Torino, Piemonte, Italy.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lunetta', 'Affiliation': 'NEuroMuscular Omnicentre (NEMO), Fondazione Serena Onlus, Milan, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Caponnetto', 'Affiliation': 'Neurological Clinic, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.'}, {'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Mazzini', 'Affiliation': 'Department of Neurology, Maggiore della Carità Hospital, University of Piemonte Orientale, Novara, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'La Bella', 'Affiliation': 'Department of Biomedicine, Neuroscience and Advanced Diagnostics, University of Palermo, Palermo, Sicilia, Italy.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Mandrioli', 'Affiliation': 'Department of Neuroscience, Azienda Ospedaliera Universitaria Modena, St. Agostino-Estense Hospital, Modena, Italy.'}, {'ForeName': 'Isabella Laura', 'Initials': 'IL', 'LastName': 'Simone', 'Affiliation': 'Neurology Unit, Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari, Bari, Puglia, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Moglia', 'Affiliation': ""'Rita Levi Montalcini' Department of Neuroscience, University of Turin, Torino, Piemonte, Italy.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Calvo', 'Affiliation': ""'Rita Levi Montalcini' Department of Neuroscience, University of Turin, Torino, Piemonte, Italy.""}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Tarella', 'Affiliation': 'Oncohematology Division, IEO European Institute of Oncology, IRCCS, University of Milan, Milano, Lombardia, Italy.'}, {'ForeName': 'Adriano', 'Initials': 'A', 'LastName': 'Chio', 'Affiliation': ""'Rita Levi Montalcini' Department of Neuroscience, University of Turin, Torino, Piemonte, Italy.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-034049'] 213,32209630,Validating the effect of Ondansetron and Mirtazapine In Treating hyperemesis gravidarum (VOMIT): protocol for a randomised placebo-controlled trial.,"INTRODUCTION Current pharmacological treatment options for hyperemesis gravidarum have been introduced based on scarce evidence and are often not sufficiently effective. Several case reports suggest that mirtazapine, an antidepressant, may be an effective treatment for hyperemesis gravidarum, but so far there are no controlled trials investigating the potential effect of mirtazapine on hyperemesis gravidarum. The antiemetic ondansetron is currently widely used to treat hyperemesis gravidarum despite sparse evidence of effect in pregnant women. This study aims to investigate the effect of mirtazapine on hyperemesis gravidarum while also providing data on the effect of ondansetron. METHODS AND ANALYSIS This randomised double-blind placebo-controlled multicentre trial will be conducted in eight Danish hospitals. One hundred and eighty pregnant women referred to secondary care for hyperemesis gravidarum will be randomly allocated to 14-day treatment with either mirtazapine, ondansetron or placebo. Main inclusion criterion will be Pregnancy Unique Quantification of Emesis (PUQE-24) score ≥13 or PUQE-24 score ≥7 if accompanied by weight loss >5% of pre-pregnancy weight or hospitalisation. Participants are eligible regardless of whether other antiemetics, including ondansetron, have been tried. The coprimary outcomes are effects of mirtazapine and ondansetron, respectively, on PUQE-24 score tested hierarchically on day 2 and day 14. Secondary outcomes include, but are not limited to, differences between the three groups in number of daily vomiting episodes, dropout due to treatment failure, use of rescue medication, weight change and side effects. ETHICS AND DISSEMINATION The trial has been approved by the Regional Committees on Health Research Ethics in the Capital Region of Denmark, the Danish Medicines Agency and the Danish Data Protection Agency. Results will be published in peer-reviewed journals and submitted to relevant conferences. TRIAL REGISTRATION NUMBER NCT03785691.",2020,The antiemetic ondansetron is currently widely used to treat hyperemesis gravidarum despite sparse evidence of effect in pregnant women.,"['eight Danish hospitals', 'One hundred and eighty pregnant women referred to secondary care for hyperemesis gravidarum', 'pregnant women']","['mirtazapine', 'mirtazapine, ondansetron or placebo', 'placebo', 'Ondansetron and Mirtazapine', 'mirtazapine and ondansetron', 'ondansetron', 'antiemetic ondansetron']","['number of daily vomiting episodes, dropout due to treatment failure, use of rescue medication, weight change and side effects']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0020450', 'cui_str': 'Pernicious Vomiting of Pregnancy'}]","[{'cui': 'C0049506', 'cui_str': 'Mirtazapine'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0162643'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",180.0,0.690313,The antiemetic ondansetron is currently widely used to treat hyperemesis gravidarum despite sparse evidence of effect in pregnant women.,"[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Ostenfeld', 'Affiliation': 'Department of Gynecology and Obstetrics, Nordsjaellands Hospital, Hillerod, Denmark.'}, {'ForeName': 'Tonny Studsgaard', 'Initials': 'TS', 'LastName': 'Petersen', 'Affiliation': 'Department of Clinical Pharmacology, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Tina Bergmann', 'Initials': 'TB', 'LastName': 'Futtrup', 'Affiliation': 'Department of Gynecology and Obstetrics, Nordsjaellands Hospital, Hillerod, Denmark.'}, {'ForeName': 'Jon Trærup', 'Initials': 'JT', 'LastName': 'Andersen', 'Affiliation': 'Department of Clinical Pharmacology, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Andreas Kryger', 'Initials': 'AK', 'LastName': 'Jensen', 'Affiliation': 'Department of Research, Nordsjaellands Hospital, Hillerod, Denmark.'}, {'ForeName': 'Hanne Brix', 'Initials': 'HB', 'LastName': 'Westergaard', 'Affiliation': 'Department of Gynecology and Obstetrics, Nordsjaellands Hospital, Hillerod, Denmark.'}, {'ForeName': 'Lars Henning', 'Initials': 'LH', 'LastName': 'Pedersen', 'Affiliation': 'Department Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Ellen Christine Leth', 'Initials': 'ECL', 'LastName': 'Løkkegaard', 'Affiliation': 'Department of Gynecology and Obstetrics, Nordsjaellands Hospital, Hillerod, Denmark Ellen.Christine.Leth.Loekkegaard@regionh.dk.'}]",BMJ open,['10.1136/bmjopen-2019-034712'] 214,32406919,"Changes in dietary inflammatory potential predict changes in sleep quality metrics, but not sleep duration.","STUDY OBJECTIVES Non-pharmacological sleep interventions may improve sleep profiles without the side-effects observed with many pharmacological sleep aids. The objective of this research was to examine the association between sleep and inflammation and to examine how changes in dietary inflammatory potential influence changes in sleep. METHODS The Inflammation Management Intervention Study (IMAGINE), which was a dietary intervention designed to lower inflammation, provided access to 24-h dietary recalls (24HR), objectively measured sleep using SensewearTM armbands, and a range of self-reported demographics, health histories, lifestyle behaviors, psychosocial metrics, anthropometric measurements, and inflammatory biomarkers. Dietary Inflammatory Index® (DII®) scores were calculated from three unannounced 24HR-derived estimated intakes of whole foods and micro and macronutrients over a 2-week period at baseline and post-intervention (i.e. month 3). Statistical analyses primarily utilized linear regression. RESULTS At baseline, for every 1-min increase in sleep onset latency, tumor necrosis factor-α increased by 0.015 pg/mL (±0.008, p = 0.05). Every one-percentage increase in sleep efficiency was associated with decreased C-reactive protein (CRP) of -0.088 mg/L (±0.032, p = 0.01). Every 1-min increase in wake-after-sleep-onset (WASO) increased both CRP and interleukin-6. Compared to participants with pro-inflammatory DII changes over 3 months, those with anti-inflammatory changes decreased WASO (0 vs. -25 min, respectively, p < 0.01) and improved sleep efficiency (-2.1% vs. +2.6%, respectively, p = 0.04). CONCLUSIONS Non-pharmacological treatments, such as anti-inflammatory diets, may improve sleep in some adults. Future research involving dietary treatments to improve sleep should not only focus on the general population, but also in those commonly experiencing co-morbid sleep complaints. CLINICAL TRIAL INFORMATION NCT02382458.",2020,"Every one-percentage increase in sleep efficiency was associated with decreased C-reactive protein (CRP) of -0.088 mg/L (± 0.032, P=0.01).",[],[],"['C-reactive protein (CRP', 'Sleep Quality Metrics', 'Dietary Inflammatory Index (DII®) scores', '24-hour dietary recalls (24HR), objectively measured sleep using Sensewear™ armbands, and a range of self-reported demographics, health histories, lifestyle behaviors, psychosocial metrics, anthropometric measurements, and inflammatory biomarkers', 'WASO', 'sleep onset latency (SOL), tumor necrosis factor-α (TNF-α', 'sleep efficiency']",[],[],"[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0385506', 'cui_str': 'didodecylindocarbocyanine'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1301852', 'cui_str': 'Armband'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0455458', 'cui_str': 'PMH - past medical history'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",,0.0144196,"Every one-percentage increase in sleep efficiency was associated with decreased C-reactive protein (CRP) of -0.088 mg/L (± 0.032, P=0.01).","[{'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Wirth', 'Affiliation': 'College of Nursing, University of South Carolina, Columbia, SC.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Jessup', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of South Carolina, Columbia, SC.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Turner-McGrievy', 'Affiliation': 'Department of Health Promotion, Education, and Behavior, Arnold School of Public Health, University of South Carolina, Columbia, SC.'}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Shivappa', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of South Carolina, Columbia, SC.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Hurley', 'Affiliation': 'Cancer Prevention and Control Program, Arnold School of Public Health, University of South Carolina, Columbia, SC.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Hébert', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of South Carolina, Columbia, SC.'}]",Sleep,['10.1093/sleep/zsaa093'] 215,32207048,"Effect of the ""Recruitment"" Maneuver on Respiratory Mechanics in Laparoscopic Sleeve Gastrectomy Surgery.","PURPOSE LSG surgery is used for surgical treatment of morbid obesity. Obesity, anesthesia, and pneumoperitoneum cause reduced pulmoner functions and a tendency for atelectasis. The alveolar ""recruitment"" maneuver (RM) keeps airway pressure high, opening alveoli, and increasing arterial oxygenation. The aim of our study is to research the effect on respiratory mechanics and arterial blood gases of performing the RM in LSG surgery. MATERIALS AND METHODS Sixty patients undergoing LSG surgery were divided into two groups (n = 30) Patients in group R had the RM performed 5 min after desufflation with 100% oxygen, 40 cmH 2 O pressure for 40 s. Group C had standard mechanical ventilation. Assessments of respiratory mechanics and arterial blood gases were made in the 10th min after induction (T1), 10th min after insufflation (T2), 5th min after desufflation (T3), and 15th min after desufflation (T4). Arterial blood gases were assessed in the 30th min (T5) in the postoperative recovery unit. RESULTS In group R, values at T5, PaO 2 were significantly high, while PaCO 2 were significantly low compared with group C. Compliance in both groups reduced with pneumoperitoneum. At T4, the compliance in the recruitment group was higher. In both groups, there was an increase in PIP with pneumoperitoneum and after desufflation this was identified to reduce to levels before pneumoperitoneum. CONCLUSION Adding the RM to PEEP administration for morbidly obese patients undergoing LSG surgery is considered to be effective in improving respiratory mechanics and arterial blood gas values and can be used safely.",2020,"In group R, values at T5, PaO 2 were significantly high, while PaCO 2 were significantly low compared with group C. Compliance in both groups reduced with pneumoperitoneum.","['morbidly obese patients undergoing LSG surgery', 'Laparoscopic Sleeve Gastrectomy Surgery', 'Sixty patients undergoing LSG surgery']","['RM performed 5\xa0min after desufflation with 100% oxygen, 40\xa0cmH 2 O pressure for 40\xa0s. Group C had standard mechanical ventilation', 'Recruitment"" Maneuver']","['Arterial blood gases', 'respiratory mechanics and arterial blood gases', 'PIP with pneumoperitoneum', 'Respiratory Mechanics', 'respiratory mechanics and arterial blood gas values']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}]","[{'cui': 'C0150411', 'cui_str': 'Blood gases, arterial measurement (procedure)'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",60.0,0.0255194,"In group R, values at T5, PaO 2 were significantly high, while PaCO 2 were significantly low compared with group C. Compliance in both groups reduced with pneumoperitoneum.","[{'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Sümer', 'Affiliation': 'Department of Anesthesiology and Reanimation, Faculty of Medicine, Bezmialem Vakif University, Istanbul, Turkey. isumer@bezmialem.edu.tr.'}, {'ForeName': 'Ufuk', 'Initials': 'U', 'LastName': 'Topuz', 'Affiliation': 'Health Cares Vocational School, İstanbul Esenyurt University, Istanbul, Turkey.'}, {'ForeName': 'Selçuk', 'Initials': 'S', 'LastName': 'Alver', 'Affiliation': 'Department of Anesthesiology and Reanimation, Faculty of Medicine, İstanbul Medipol University, Istanbul, Turkey.'}, {'ForeName': 'Tarik', 'Initials': 'T', 'LastName': 'Umutoglu', 'Affiliation': 'İstanbul Acıbadem Taksim Hospital, Istanbul, Turkey.'}, {'ForeName': 'Mefkur', 'Initials': 'M', 'LastName': 'Bakan', 'Affiliation': 'Health Cares Vocational School, İstanbul Esenyurt University, Istanbul, Turkey.'}, {'ForeName': 'Seniyye Ülgen', 'Initials': 'SÜ', 'LastName': 'Zengin', 'Affiliation': 'Department of Anesthesiology and Reanimation, Faculty of Medicine, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Halil', 'Initials': 'H', 'LastName': 'Coşkun', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Ziya', 'Initials': 'Z', 'LastName': 'Salihoglu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Cerrahpasa Faculty of Medicine, İstanbul University Cerrahpasa, Istanbul, Turkey.'}]",Obesity surgery,['10.1007/s11695-020-04551-y'] 216,32068975,"A program of exercise, brain training, and lecture to prevent cognitive decline.","OBJECTIVE We examined the benefits of a community-based program combining physical exercise, cognitive training, and education on dementia and lifestyle habits. METHODS This crossover open-label trial included 141 community-dwelling elderly people with suspected mild cognitive decline (MCD). Subjects were assigned to a 6-month intervention-first/6-month observation-second (INT-OBS) group or an OBS-INT group. The 6-month intervention consisted of 2 h of physical exercise, cognitive training, and classroom study or rest once weekly. Primary outcome was change in Touch Panel-type Dementia Assessment Scale (TDAS) score. RESULTS TDAS score improved significantly during the intervention period compared with the observation period for all subjects (P < 0.05). Some physical functions also improved significantly during the intervention period compared with the observation period in the OBS-INT group (P < 0.05). INTERPRETATION This community-based program improved both cognitive and physical function in elderly people with suspected MCD.",2020,"Some physical functions also improved significantly during the intervention period compared with the observation period in the OBS-INT group (P < 0.05). ","['141 community-dwelling elderly people with suspected mild cognitive decline (MCD', 'elderly people with suspected MCD']","['exercise, brain training, and lecture', '6-month intervention-first/6-month observation-second (INT-OBS) group or an OBS-INT group', 'community-based program combining physical exercise, cognitive training, and education', '2\xa0h of physical exercise, cognitive training, and classroom study or rest once weekly']","['TDAS score', 'change in Touch Panel-type Dementia Assessment Scale (TDAS) score']","[{'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0234985', 'cui_str': 'Cognitive Decline'}, {'cui': 'C1636149', 'cui_str': 'Mcd'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}]",141.0,0.0220147,"Some physical functions also improved significantly during the intervention period compared with the observation period in the OBS-INT group (P < 0.05). ","[{'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Kouzuki', 'Affiliation': 'Department of Biological Regulation, School of Health Science, Faculty of Medicine, Tottori University, 86, Nishi-cho, Yonago, 683-8503, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Division of Medical Science in Sports and Exercise, Department of Social Medicine, Faculty of Medicine, Tottori University, 4-101 Koyama-cho Minami, Tottori, 680-8550, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Wada-Isoe', 'Affiliation': 'Division of Neurology, Department of Brain and Neurological Sciences, Faculty of Medicine, Tottori University, 36-1, Nichi-cho, Yonago, 683-8504, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Takeda', 'Affiliation': 'Department of Clinical Psychology, Tottori University Graduate School of Medical Sciences, 86, Nishi-cho, Yonago, 683-8503, Japan.'}, {'ForeName': 'Atsuhito', 'Initials': 'A', 'LastName': 'Tamura', 'Affiliation': 'The Nanbu Town National Health Insurance Saihaku Hospital, 397, Yamato, Nanbu-cho, Saihaku, 683-0323, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Takanashi', 'Affiliation': 'Department of Occupational Therapist, YMCA College of Medical & Human Services in Yonago, 3-3-2, Kinkai-cho, Yonago, Tottori, 683-0825, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Azumi', 'Affiliation': 'Department of Rehabilitation, Satoni Den-en Clinic, 54-2, Satoni, Tottori-shi, Tottori, 680-0935, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Kojima', 'Affiliation': 'Social Welfare Corporation Kohen, Nursing home Sakaikohen, 2083, Seido-cho, Sakaiminato, 684-0063, Japan.'}, {'ForeName': 'Chikako', 'Initials': 'C', 'LastName': 'Maruyama', 'Affiliation': 'Kotoura Town Hall, 591-2, Tokuman, Kotoura-cho, Touhakugunn, 689-2392, Japan.'}, {'ForeName': 'Maki', 'Initials': 'M', 'LastName': 'Hayashi', 'Affiliation': 'Kotoura Town Hall, 591-2, Tokuman, Kotoura-cho, Touhakugunn, 689-2392, Japan.'}, {'ForeName': 'Michimi', 'Initials': 'M', 'LastName': 'Itou', 'Affiliation': 'Yonago Public Comprehensive Support Center for Shoutoku-Community, 1238 Ishii, Yonago, Tottori, 683-0021, Japan.'}, {'ForeName': 'Katsuya', 'Initials': 'K', 'LastName': 'Urakami', 'Affiliation': 'Department of Biological Regulation, School of Health Science, Faculty of Medicine, Tottori University, 86, Nishi-cho, Yonago, 683-8503, Japan.'}]",Annals of clinical and translational neurology,['10.1002/acn3.50993'] 217,32405884,Effect of patient-specific instrument on lowering threshold for junior physicians to perform total hip arthroplasty on developmental dysplasia of the hip patients.,"PURPOSE To create a patient-specific instrument (PSI) in lowering the surgical experience requirement for junior physicians to perform total hip arthroplasty (THA) on developmental dysplasia of the hip (DDH) patients. METHODS Combined with rapid prototyping technology, we created a PSI and established DDH hip model in vitro. We enrolled 48 junior physicians and randomly assigned them into two groups. After creation of the PSI, they performed simulated THA surgery on a full-scale hip model with or without PSI on DDH models. The planned prothesis orientation, post-operative prothesis orientation, and surgery time were recorded. RESULTS The final cup inclination was 42.0 ± 0.8° in PSI group and 37.8 ± 2.0° in control group, while final cup anteversion was 16.0 ± 0.7° in PSI group and 24.7 ± 3.5° in control group. The △inclination in PSI group was smaller than that in control group (4.2 ± 0.5° vs 9.5 ± 1.4°, P < 0.01), so does △inclination (2.9 ± 0.4° in PSI group vs 15.2 ± 2.5° in control group, P < 0.01). The outlier percent was 8.3% in PSI group and 70.8% in control group (P < 0.01). At the same time, the PSI group did not prolong the operation time (P = 0.551). CONCLUSION The PSI can greatly increase the accuracy of placing the cup orientation and lower the threshold for junior physicians to perform THA on DDH patients. It could be a training tool for them to increase their THA surgical skills.",2020,The outlier percent was 8.3% in PSI group and 70.8% in control group (P < 0.01).,"['junior physicians to perform total hip arthroplasty (THA) on developmental dysplasia of the hip (DDH) patients', '48 junior physicians', 'junior physicians to perform total hip arthroplasty on developmental dysplasia of the hip patients']","['patient-specific instrument (PSI', 'patient-specific instrument', 'rapid prototyping technology']",['operation time'],"[{'cui': 'C0524635', 'cui_str': 'Physicians, Junior'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C4551649', 'cui_str': 'Congenital hip dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",48.0,0.0184023,The outlier percent was 8.3% in PSI group and 70.8% in control group (P < 0.01).,"[{'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Xiao', 'Affiliation': 'Department of Sports Medicine, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Chenggong', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Digital Orthopaedic Laboratory, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Da', 'Initials': 'D', 'LastName': 'Zhong', 'Affiliation': 'Digital Orthopaedic Laboratory, Xiangya Hospital, Central South University, Changsha, Hunan, China. Dr_zhongda@126.com.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Lei', 'Affiliation': 'Digital Orthopaedic Laboratory, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Yihe', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Digital Orthopaedic Laboratory, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Shilong', 'Initials': 'S', 'LastName': 'Su', 'Affiliation': 'Digital Orthopaedic Laboratory, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}]",International orthopaedics,['10.1007/s00264-020-04599-6'] 218,32404001,Economic evaluation alongside a randomised controlled trial to assess the effectiveness and cost-effectiveness of acupuncture in the management of chemotherapy-induced peripheral neuropathy.,"OBJECTIVE To assess the cost-effectiveness of acupuncture in the management of chemotherapy-induced peripheral neuropathy (CIPN) in Hong Kong. METHODS A within trial cost-utility analysis with the primary endpoint for the economic evaluation being the Quality Adjusted Life Year (QALY) and associated Incremental Cost Effectiveness Ratio (ICER) over 14 weeks of treatment. A secondary cost-effectiveness analysis was undertaken with the endpoint being change in pain as measured on the Brief Pain Inventory (BPI). RESULTS Eighty-seven patients were randomised to acupuncture or usual care. Acupuncture resulted in significant improvements in pain intensity (8- and 14-week mean changes compared to usual care of -1.8 and -1.8, respectively), pain interference (8- and 14-week mean changes compared to usual care of -1.5 and -0.9, respectively) and indicators of quality of life and neurotoxicity-related symptoms. However, in the economic evaluation there was little difference in QALYs between the two arms (mean change 0.209 and 0.200 in the acupuncture and usual care arms, respectively). Also, costs yielded deterministic ICERs of HK$616,965.62, HK$824,083.44 and HK$540,727.56 per QALY gained from the health care provider perspective, the societal perspective and the patient perspective, respectively. These costs are significantly higher than the cost-effectiveness threshold of HK$180,450 that was used for the base case analysis. CONCLUSION While acupuncture can improve symptoms and quality of life indicators related to CIPN, it is unlikely to be a cost-effective treatment for CIPN-related pain in health care systems with limited resources. TRIAL REGISTRATION NUMBER NCT02553863 (ClinicalTrials.gov) post-results.",2021,"Acupuncture resulted in significant improvements in pain intensity (8- and 14-week mean changes compared to usual care of -1.8 and -1.8, respectively), pain interference (8- and 14-week mean changes compared to usual care of -1.5 and -0.9, respectively) and indicators of quality of life and neurotoxicity-related symptoms.",['Eighty-seven patients'],"['acupuncture', 'CIPN', 'Acupuncture']","['Brief Pain Inventory (BPI', 'pain intensity', 'Quality Adjusted Life Year (QALY) and associated Incremental Cost Effectiveness Ratio (ICER', 'symptoms and quality of life indicators', 'quality of life and neurotoxicity-related symptoms', 'effectiveness and cost-effectiveness', 'cost-effectiveness', 'pain interference']","[{'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxicity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}]",87.0,0.195171,"Acupuncture resulted in significant improvements in pain intensity (8- and 14-week mean changes compared to usual care of -1.8 and -1.8, respectively), pain interference (8- and 14-week mean changes compared to usual care of -1.5 and -0.9, respectively) and indicators of quality of life and neurotoxicity-related symptoms.","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Molassiotis', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong SAR.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Dawkins', 'Affiliation': 'Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Longo', 'Affiliation': 'Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Lorna Kp', 'Initials': 'LK', 'LastName': 'Suen', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong SAR.'}, {'ForeName': 'Hui Lin', 'Initials': 'HL', 'LastName': 'Cheng', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong SAR.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Mok', 'Affiliation': 'Department of Clinical Oncology, Prince of Wales Hospital, Hung Hom, Hong Kong SAR.'}, {'ForeName': 'Claire T', 'Initials': 'CT', 'LastName': 'Hulme', 'Affiliation': 'Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Winnie', 'Initials': 'W', 'LastName': 'Yeo', 'Affiliation': 'Department of Clinical Oncology, Prince of Wales Hospital, Hung Hom, Hong Kong SAR.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1177/0964528420920285'] 219,32403158,"Stenting the ureteroneocystostomy reduces urological complications in kidney transplantation: a noninferiority randomized controlled trial, SPLINT trial.","The role of ureteral stents in living-donor kidney transplantation remains uncertain. In this randomized controlled trial (SPLINT), we compared urological complications in living-donor kidney transplantations performed with or without stents. We included 200 consecutive patients that received living-donor kidney transplantations at the Erasmus MC, University Medical Center, Rotterdam. Patients (124 males, 76 females, mean age 54 ± 13) were randomized for suprapubic externalized single J stents (N = 100) or no stent (N = 100). The primary outcome was the probability of a percutaneous nephrostomy insertion (PCN) during a 12-month follow-up. To assess whether no stenting is noninferior to stenting, we allowed the probability of a PCN to increase by at most 5% (this is the noninferiority margin). Baseline characteristics were comparable between groups. In the no-stent group, there were more PCN insertions, 14% (95% CI 4.3-23.7%); urinary leakages, 12% (95% CI 5.4-21.3%); and surgical re-interventions because of urological complications, 8% (95% CI 1.5-14.5%). The stent group had more hematuria, 26% (95% CI 13.1-38.9%); and graft rejections, 15% (95% CI 2.7-27.3%). Patients in both groups had similar mean GFRs at several time points. Besides a better Euro-Qol-5D in the no-stent group at 2 and 6 weeks postoperative, similar quality of life was reported based on SF-36 and Euro-Qol-5D scores. In this trial, noninferiority has not been demonstrated for no-stent placement in relation to the number urological complications.",2020,The stent group had more hematuria 26% (95%CI 13.1- 38.9%) and graft rejections 15% (95%CI 2.7- 27.3%).,"['kidney transplantation', '200 consecutive patients that received living donor kidney transplantations at the Erasmus MC, University Medical Center Rotterdam', 'Patients (124 males, 76 females, mean age 54 ± 13']","['ureteral stents', 'suprapubic externalized single J stents (N=100) or no stent', 'ureteroneocystostomy', 'living donor kidney transplantations performed with or without stents']","['quality of life', 'urological complications', 'hematuria', 'probability of a percutaneous nephrostomy insertion (PCN', 'graft rejections', 'urinary leakages']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0183518', 'cui_str': 'Ureteric stent'}, {'cui': 'C0205498', 'cui_str': 'Suprapubic approach'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0194307', 'cui_str': 'Intravesical reimplantation of ureter'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0018965', 'cui_str': 'Blood in urine'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0027724', 'cui_str': 'Percutaneous insertion of nephrostomy tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0018129', 'cui_str': 'Graft rejection'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}]",200.0,0.322335,The stent group had more hematuria 26% (95%CI 13.1- 38.9%) and graft rejections 15% (95%CI 2.7- 27.3%).,"[{'ForeName': 'Liselotte S S', 'Initials': 'LSS', 'LastName': 'Ooms', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Minnee', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Frank J M F', 'Initials': 'FJMF', 'LastName': 'Dor', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Diederik J A N', 'Initials': 'DJAN', 'LastName': 'Kimenai', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Khe C K', 'Initials': 'KCK', 'LastName': 'Tran', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Hermien', 'Initials': 'H', 'LastName': 'Hartog', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'van de Wetering', 'Affiliation': 'Department of Nephrology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Sten P', 'Initials': 'SP', 'LastName': 'Willemsen', 'Affiliation': 'Department of Biostatistics, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Jan N M', 'Initials': 'JNM', 'LastName': 'IJzermans', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Turkan', 'Initials': 'T', 'LastName': 'Terkivatan', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.'}]",Transplant international : official journal of the European Society for Organ Transplantation,['10.1111/tri.13638'] 220,32185802,Effects of sweet orange aromatherapy on pain and anxiety during needle insertion among patients undergoing hemodialysis: A quasi-experimental study.,"PURPOSE Patients undergoing hemodialysis experience pain and anxiety during needle insertion, and the scientific interest in aromatherapy in reducing pain and anxiety is increasing. Thus, this study aimed to determine the effects of sweet orange aromatherapy on pain and anxiety during needle insertion in hemodialysis. DESIGN Quasi-experimental, pretest, and posttest. METHODS This study was carried out among 50 patients with chronic kidney disease who were non-randomly assigned to either sweet orange aromatherapy or calm breathing in three outpatient hemodialysis centers in the Philippines between July and August 2015. The numeric rating scale and adapted state-trait anxiety inventory were utilized to measure pain and anxiety. RESULTS After the intervention, both the pain and anxiety scores were significantly lower for patients who received sweet orange aromatherapy than those who received calm breathing. The results obtained modest effect sizes that imply high practical significance. CONCLUSION The sweet orange aromatherapy can be effective in reducing pain and anxiety. Thus, this can be used by nurses as an alternative and complementary approach to reduce both pain and anxiety in painful procedures like needle insertion.",2020,"After the intervention, both the pain and anxiety scores were significantly lower for patients who received sweet orange aromatherapy than those who received calm breathing.","['Patients undergoing hemodialysis experience pain and anxiety during needle insertion', '50 patients with chronic kidney disease who were non-randomly assigned to either', 'hemodialysis', 'patients undergoing hemodialysis', 'in three outpatient hemodialysis centers in the Philippines between July and August 2015']","['sweet orange aromatherapy', 'sweet orange aromatherapy or calm breathing']","['pain and anxiety scores', 'numeric rating scale and adapted state-trait anxiety inventory', 'pain and anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0522462', 'cui_str': 'Orange Tree'}, {'cui': 'C0376547', 'cui_str': 'Therapy, Aroma'}, {'cui': 'C0150157', 'cui_str': 'Calming'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",50.0,0.0191466,"After the intervention, both the pain and anxiety scores were significantly lower for patients who received sweet orange aromatherapy than those who received calm breathing.","[{'ForeName': 'Ma Catherine Grace Mendoza', 'Initials': 'MCGM', 'LastName': 'Reyes', 'Affiliation': 'College of Nursing, University of Santo Tomas, Manila, Philippines.'}, {'ForeName': 'Ma Corrine Grace Mendoza', 'Initials': 'MCGM', 'LastName': 'Reyes', 'Affiliation': 'College of Nursing, University of Santo Tomas, Manila, Philippines.'}, {'ForeName': 'Krystal Gale Lastrella', 'Initials': 'KGL', 'LastName': 'Ribay', 'Affiliation': 'College of Nursing, University of Santo Tomas, Manila, Philippines.'}, {'ForeName': 'Emmanuel Dayao', 'Initials': 'ED', 'LastName': 'Paragas', 'Affiliation': 'College of Nursing, University of Santo Tomas, Manila, Philippines.'}]",Nursing forum,['10.1111/nuf.12447'] 221,32194999,"Efficacy of FLU-v, a broad-spectrum influenza vaccine, in a randomized phase IIb human influenza challenge study.","FLU-v, developed by PepTcell (SEEK), is a peptide vaccine aiming to provide a broadly protective cellular immune response against influenza A and B. A randomized, double-blind, placebo-controlled, single-center, phase IIb efficacy and safety trial was conducted. One hundred and fifty-three healthy individuals 18-55 years of age were randomized to receive one or two doses of adjuvanted FLU-v or adjuvanted placebo subcutaneously on days -43 and -22, prior to intranasal challenge on day 0 with the A/California/04/2009/H1N1 human influenza A challenge virus. The primary objective of the study was to identify a reduction in mild to moderate influenza disease (MMID) defined as the presence of viral shedding and clinical influenza symptoms. Single-dose adjuvanted FLU-v recipients ( n  = 40) were significantly less likely to develop MMID after challenge vs placebo ( n  = 42) (32.5% vs 54.8% p  = 0.035). FLU-v should continue to be evaluated and cellular immunity explored further as a possible important correlate of protection against influenza.",2020,Single-dose adjuvanted FLU-v recipients ( n  = 40) were significantly less likely to develop MMID after challenge vs placebo ( n  = 42) (,['One hundred and fifty-three healthy individuals 18-55 years of age'],"['FLU-v, a broad-spectrum influenza vaccine', 'California/04/2009/H1N1 human influenza A challenge virus', 'placebo', 'adjuvanted FLU-v or adjuvanted placebo']",[],"[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0580264', 'cui_str': 'H1N1'}, {'cui': 'C0042776', 'cui_str': 'Virus'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],153.0,0.144139,Single-dose adjuvanted FLU-v recipients ( n  = 40) were significantly less likely to develop MMID after challenge vs placebo ( n  = 42) (,"[{'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Pleguezuelos', 'Affiliation': 'SEEK Central Point, 45 Beech Street, London, EC2Y 8AD UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'James', 'Affiliation': 'SEEK Central Point, 45 Beech Street, London, EC2Y 8AD UK.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Fernandez', 'Affiliation': 'SEEK Central Point, 45 Beech Street, London, EC2Y 8AD UK.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Lopes', 'Affiliation': 'h-VIVO Services Ltd, London, UK.'}, {'ForeName': 'Luz Angela', 'Initials': 'LA', 'LastName': 'Rosas', 'Affiliation': '3Viral Pathogenesis and Evolution Section, Laboratory of Infectious Diseases, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892 USA.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Cervantes-Medina', 'Affiliation': '4LID Clinical Studies Unit, Laboratory of Infectious Diseases, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892 USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Cleath', 'Affiliation': '4LID Clinical Studies Unit, Laboratory of Infectious Diseases, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892 USA.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Edwards', 'Affiliation': '4LID Clinical Studies Unit, Laboratory of Infectious Diseases, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892 USA.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Neitzey', 'Affiliation': '4LID Clinical Studies Unit, Laboratory of Infectious Diseases, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892 USA.'}, {'ForeName': 'Wenjuan', 'Initials': 'W', 'LastName': 'Gu', 'Affiliation': '5Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, Bethesda, MD 20892 USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Hunsberger', 'Affiliation': '5Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, Bethesda, MD 20892 USA.'}, {'ForeName': 'Jeffery K', 'Initials': 'JK', 'LastName': 'Taubenberger', 'Affiliation': '3Viral Pathogenesis and Evolution Section, Laboratory of Infectious Diseases, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892 USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Stoloff', 'Affiliation': 'SEEK Central Point, 45 Beech Street, London, EC2Y 8AD UK.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Memoli', 'Affiliation': '4LID Clinical Studies Unit, Laboratory of Infectious Diseases, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892 USA.'}]",NPJ vaccines,['10.1038/s41541-020-0174-9'] 222,31776782,The True Story on Deficiencies After Sleeve Gastrectomy: Results of a Double-Blind RCT.,"BACKGROUND Since a few years, the laparoscopic sleeve gastrectomy (SG) has become the most performed bariatric operation worldwide. However, as with all bariatric procedures, SG also leads to vitamin and mineral deficiencies post-operatively and standard multivitamin supplements are probably not sufficient. OBJECTIVE The present study evaluates the effectiveness of a specialized multivitamin supplement for SG patients (WLS Optimum 1.0, FitForMe, Rotterdam, the Netherlands), compared to a standard multivitamin supplement (sMVS). DESIGN A double-blind randomized controlled trial was performed. For 12 months, patients in the intervention group received WLS Optimum, containing elevated doses of multiple vitamins and minerals. Patients in the control group were provided with sMVS, containing 100% of the recommended dietary allowance. RESULTS In total, 139 patients were available for analysis (WLS Optimum, n = 69; sMVS, n = 70). Intention-to-treat analyses revealed more folic acid deficiencies and higher serum vitamin B1 levels in the WLS Optimum group. Per protocol analyses showed that in patients using WLS Optimum, serum folic acid and vitamin B1 levels were higher, serum PTH levels were lower, and only one patient (2.6%) was anemic compared to 11 patients (17.5%) using a sMVS (p < 0.05 for all). No differences were found in prevalence of deficiencies for iron, vitamin B12, vitamin D, and other vitamins and minerals. CONCLUSIONS This optimized multivitamin supplement only affected serum levels of folic acid, PTH and vitamin B1, and anemia rates compared to a sMVS. There is a clear need to further optimize multivitamin supplementation for SG patients. Besides, non-compliance with multivitamin supplements remains an important issue that should be dealt with. CLINICAL TRIAL REGISTRY The study protocol was registered at the clinical trials registry of the National Institutes of Health (ClinicalTrials.gov; identifier NCT01609387).",2020,"No differences were found in prevalence of deficiencies for iron, vitamin B12, vitamin D, and other vitamins and minerals. ","['139 patients were available for analysis (WLS Optimum, n\u2009=\u200969; sMVS, n\u2009=\u200970', 'SG patients (WLS Optimum 1.0, FitForMe, Rotterdam, the Netherlands']","['multivitamin supplements', 'laparoscopic sleeve gastrectomy (SG', 'Sleeve Gastrectomy', 'specialized multivitamin supplement', 'WLS Optimum, containing elevated doses of multiple vitamins and minerals', 'Double-Blind RCT', 'standard multivitamin supplement (sMVS']","['serum levels of folic acid, PTH and vitamin B1, and anemia rates', 'prevalence of deficiencies for iron, vitamin B12, vitamin D, and other vitamins and minerals', 'folic acid deficiencies and higher serum vitamin B1 levels', 'serum PTH levels', 'serum folic acid and vitamin B1 levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0373727', 'cui_str': 'Vitamin B-1 measurement'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0042845', 'cui_str': 'cyanocobalamin'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0016412', 'cui_str': 'Folic Acid Deficiency'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1446067', 'cui_str': 'Serum vitamin B1 measurement'}]",139.0,0.172791,"No differences were found in prevalence of deficiencies for iron, vitamin B12, vitamin D, and other vitamins and minerals. ","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Heusschen', 'Affiliation': 'Department of Surgery, Vitalys Clinic and Rijnstate Hospital, Wagnerlaan 55, Arnhem, 6800 TA, The Netherlands. LHeusschen@Rijnstate.nl.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Schijns', 'Affiliation': 'Department of Surgery, Vitalys Clinic and Rijnstate Hospital, Wagnerlaan 55, Arnhem, 6800 TA, The Netherlands.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Ploeger', 'Affiliation': 'Department of Surgery, Vitalys Clinic and Rijnstate Hospital, Wagnerlaan 55, Arnhem, 6800 TA, The Netherlands.'}, {'ForeName': 'Laura N', 'Initials': 'LN', 'LastName': 'Deden', 'Affiliation': 'Department of Surgery, Vitalys Clinic and Rijnstate Hospital, Wagnerlaan 55, Arnhem, 6800 TA, The Netherlands.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Hazebroek', 'Affiliation': 'Department of Surgery, Vitalys Clinic and Rijnstate Hospital, Wagnerlaan 55, Arnhem, 6800 TA, The Netherlands.'}, {'ForeName': 'Frits J', 'Initials': 'FJ', 'LastName': 'Berends', 'Affiliation': 'Department of Surgery, Vitalys Clinic and Rijnstate Hospital, Wagnerlaan 55, Arnhem, 6800 TA, The Netherlands.'}, {'ForeName': 'Edo O', 'Initials': 'EO', 'LastName': 'Aarts', 'Affiliation': 'Department of Surgery, Vitalys Clinic and Rijnstate Hospital, Wagnerlaan 55, Arnhem, 6800 TA, The Netherlands.'}]",Obesity surgery,['10.1007/s11695-019-04252-1'] 223,32189108,'Minimal symptom expression' in patients with acetylcholine receptor antibody-positive refractory generalized myasthenia gravis treated with eculizumab.,"BACKGROUND The efficacy and tolerability of eculizumab were assessed in REGAIN, a 26-week, phase 3, randomized, double-blind, placebo-controlled study in anti-acetylcholine receptor antibody-positive (AChR+) refractory generalized myasthenia gravis (gMG), and its open-label extension. METHODS Attainment of 'minimal symptom expression' was evaluated using patient-reported outcome measures of gMG symptoms [MG activities of daily living scale (MG-ADL), 15-item MG quality of life questionnaire (MG-QOL15)] at the completion of REGAIN and during the open-label extension. 'Minimal symptom expression' was defined as MG-ADL total score of 0-1 or MG-QOL15 total score of 0-3. RESULTS At REGAIN week 26, more eculizumab-treated patients achieved 'minimal symptom expression' versus placebo [MG-ADL: 21.4% vs 1.7%; difference 19.8%; 95% confidence interval (CI) 8.5, 31.0; p = 0.0007; MG-QOL15: 16.1% vs 1.7%; difference 14.4%; 95% CI 4.3, 24.6; p = 0.0069]. During the open-label extension, the proportion of patients in the placebo/eculizumab group who achieved 'minimal symptom expression' increased after initiating eculizumab treatment and was sustained through 130 weeks of open-label eculizumab (MG-ADL: 1.7 to 27.8%; MG-QOL15: 1.7 to 19.4%). At extension study week 130, similar proportions of patients in the eculizumab/eculizumab and placebo/eculizumab groups achieved 'minimal symptom expression' (MG-ADL: 22.9% and 27.8%, respectively, p = 0.7861; MG-QOL15: 14.3% and 19.4%, respectively, p = 0.7531). The long-term tolerability of eculizumab was consistent with previous reports. CONCLUSIONS Patients with AChR+ refractory gMG who receive eculizumab can achieve sustained 'minimal symptom expression' based on patient-reported outcomes. 'Minimal symptom expression' may be a useful tool in measuring therapy effectiveness in gMG. TRIAL REGISTRATION ClinicalTrials.gov NCT01997229, NCT02301624.",2020,"At REGAIN week 26, more eculizumab-treated patients achieved 'minimal symptom expression' versus placebo [MG-ADL: 21.4% vs 1.7%; difference 19.8%; 95% confidence interval (CI) 8.5, 31.0; p = 0.0007; MG-QOL15: 16.1% vs 1.7%; difference 14.4%; 95% CI 4.3, 24.6; p = 0.0069].","['patients with acetylcholine receptor antibody-positive refractory generalized myasthenia gravis treated with', 'Patients with AChR+ refractory gMG']","['placebo/eculizumab', 'acetylcholine receptor antibody-positive (AChR+) refractory generalized myasthenia gravis (gMG', 'placebo', 'eculizumab/eculizumab and placebo/eculizumab', 'placebo [MG-ADL', 'open-label eculizumab (MG-ADL', 'eculizumab']","['minimal symptom expression', 'Minimal symptom expression', 'gMG symptoms [MG activities of daily living scale (MG-ADL), 15-item MG quality of life questionnaire (MG-QOL15']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0236516', 'cui_str': 'Acetylcholine receptor antibody (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0751339', 'cui_str': 'Myasthenia Gravis, Generalized'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0765796', 'cui_str': 'GMG'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1541483', 'cui_str': 'eculizumab'}, {'cui': 'C0236516', 'cui_str': 'Acetylcholine receptor antibody (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0751339', 'cui_str': 'Myasthenia Gravis, Generalized'}, {'cui': 'C0765796', 'cui_str': 'GMG'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0765796', 'cui_str': 'GMG'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0222045'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0905574,"At REGAIN week 26, more eculizumab-treated patients achieved 'minimal symptom expression' versus placebo [MG-ADL: 21.4% vs 1.7%; difference 19.8%; 95% confidence interval (CI) 8.5, 31.0; p = 0.0007; MG-QOL15: 16.1% vs 1.7%; difference 14.4%; 95% CI 4.3, 24.6; p = 0.0069].","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Vissing', 'Affiliation': 'Department of Neurology, Copenhagen Neuromuscular Center, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100, Copenhagen, Denmark. john.vissing@regionh.dk.'}, {'ForeName': 'Saiju', 'Initials': 'S', 'LastName': 'Jacob', 'Affiliation': 'Queen Elizabeth Neuroscience Centre and Wellcome Trust Clinical Research Facility, University Hospitals Birmingham NHS Foundation Trust, Mindelsohn Way, Edgbaston, Birmingham, B15 2WB, UK.'}, {'ForeName': 'Kenji P', 'Initials': 'KP', 'LastName': 'Fujita', 'Affiliation': 'Alnylam Pharmaceuticals, 675 West Kendall Street, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': ""O'Brien"", 'Affiliation': 'Alexion Pharmaceuticals, 121 Seaport Boulevard, Boston, MA, 02210, USA.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Howard', 'Affiliation': 'Department of Neurology, University of North Carolina, 170 Manning Drive, Chapel Hill, NC, 27599-7025, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of neurology,['10.1007/s00415-020-09770-y'] 224,32107817,Effectiveness of WhatsApp online group discussion for smoking relapse prevention: protocol for a pragmatic randomized controlled trial.,"BACKGROUND AND AIMS Sustained psychosocial support via online social groups may help former tobacco users maintain abstinence. This study aims to examine the effectiveness of participating in a WhatsApp social group for long-term smoking cessation. DESIGN Two-arm, open-labelled, pragmatic, individually randomized controlled trial. SETTING All participants are service users of smoking cessation clinics, and all interventions are delivered via mobile phones. PARTICIPANTS Participants included 1008 adult quitters who self-report no tobacco use in the past 3-30 days. INTERVENTIONS The intervention group (n = 504) will join a WhatsApp social group to receive standardized and theory-based reminders of smoking relapse prevention and participate in discussion with other WhatsApp group members using their own mobile phones. All social groups will be led by counselors or specialist nurse practitioners. The control group (n = 504) will receive similar reminders via short messages to their own mobile phones but will not interact with other participants. The intervention duration for both groups is 8 weeks. Both groups will receive a booklet at baseline about how to prevent smoking relapse. MEASUREMENTS The primary outcome is biochemically validated tobacco abstinence at 12 months after consent. COMMENTS The findings will provide evidence concerning the utility of operating online social group discussion for prevention of smoking relapse and sustaining long-term abstinence.",2020,"The control group (n=504) will receive similar reminders via short messages to their own mobile phones, but will not interact with other participants.","['All participants are service users of smoking cessation clinics, and all interventions are delivered via mobile phones', '1,008 adult quitters who self-report no tobacco use in the past 3 to 30 days']","['WhatsApp online group discussion', 'intervention group (n=504) will join a WhatsApp social group to receive standardized and theory-based reminders of smoking relapse prevention and participate in discussion with other WhatsApp group members using their own mobile phones', 'similar reminders via short messages to their own mobile phones']",['tobacco abstinence'],"[{'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0687744', 'cui_str': 'Social group (observable entity)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0679867', 'cui_str': 'Relapse Prevention'}, {'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco Products'}]",1008.0,0.146403,"The control group (n=504) will receive similar reminders via short messages to their own mobile phones, but will not interact with other participants.","[{'ForeName': 'Yee Tak Derek', 'Initials': 'YTD', 'LastName': 'Cheung', 'Affiliation': 'School of Nursing, the University of Hong Kong, Hong Kong.'}, {'ForeName': 'Ching Han Helen', 'Initials': 'CHH', 'LastName': 'Chan', 'Affiliation': 'Integrated Centre on Smoking Cessation, Tung Wah Group of Hospitals, Hong Kong.'}, {'ForeName': 'Kin Sang', 'Initials': 'KS', 'LastName': 'Ho', 'Affiliation': 'Integrated Centre on Smoking Cessation, Tung Wah Group of Hospitals, Hong Kong.'}, {'ForeName': 'Wai-Yin Patrick', 'Initials': 'WP', 'LastName': 'Fok', 'Affiliation': 'Integrated Centre on Smoking Cessation, Tung Wah Group of Hospitals, Hong Kong.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Conway', 'Affiliation': 'Department of Biomedical Informatics, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Carlos King Ho', 'Initials': 'CKH', 'LastName': 'Wong', 'Affiliation': 'Department of Family Medicine and Primary Care, the University of Hong Kong, Hong Kong.'}, {'ForeName': 'William Ho Cheung', 'Initials': 'WHC', 'LastName': 'Li', 'Affiliation': 'School of Nursing, the University of Hong Kong, Hong Kong.'}, {'ForeName': 'Man Ping', 'Initials': 'MP', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, the University of Hong Kong, Hong Kong.'}, {'ForeName': 'Tai Hing', 'Initials': 'TH', 'LastName': 'Lam', 'Affiliation': 'School of Public Health, the University of Hong Kong, Hong Kong.'}]","Addiction (Abingdon, England)",['10.1111/add.15027'] 225,32193264,Influence of combined vitamin D 3 supplementation and resistance exercise training on musculoskeletal health in older men and women (EXVITD): protocol for a randomised controlled trial.,"INTRODUCTION Sarcopenia is a progressive loss in muscle mass, strength and function, the adverse consequences of which are severe, affecting quality of life and placing an increasing burden on social and healthcare systems. Vitamin D status is known to be associated with markers of sarcopenia, namely muscle mass, strength and function. Also, resistance exercise training (RET) is currently the only proven intervention to treat sarcopenia. However, very little data exist on the influence of combining the two interventions of vitamin D supplementation and resistance exercise training, although a recent systematic review provides tentative support for the current study's hypothesis that the combined intervention may further improve musculoskeletal function above exercise training alone. The aim of the present study is to determine whether vitamin D 3 supplementation is any more effective in improving musculoskeletal function when combined with RET compared with exercise training alone in older adults. METHODS AND ANALYSIS This double-blinded randomised placebo-controlled trial will recruit a target of 127 eligible men and women aged ≥65 years living independently or in sheltered housing within the Birmingham area to two groups: (1) 6 months RET and placebo or (2) 6 months RET and 800 IU/d vitamin D 3 . Measures of muscle power (Nottingham Power Rig), body composition (dual energy X-ray absorptiometry), muscle function (short physical performance battery, timed up and go), falls and fractures as events will be assessed. Assessments will take place at baseline and postintervention, with intermittent monitoring of bone turnover, calcium and vitamin D. The primary outcome will be lower limb extensor power output. Analyses of within-group changes and between-group differences in outcome measures are planned. ETHICS AND DISSEMINATION The EXVITD study has ethical approval granted by the Black Country National Health Service Research Ethics Committee (14/WM/1220). Results of this trial will be submitted for publication in peer-reviewed journals and presented at conferences. The study is being conducted according to the principles of the Declaration of Helsinki. Trial registration number NCT02467153; Post-results.",2020,"Measures of muscle power (Nottingham Power Rig), body composition (dual energy X-ray absorptiometry), muscle function (short physical performance battery, timed up and go), falls and fractures as events will be assessed.","['older men and women (EXVITD', 'or (2) 6 months RET and 800\u2009IU', '127 eligible men and women aged ≥65 years living independently or in sheltered housing within the Birmingham area to two groups: (1) 6 months', 'older adults']","['resistance exercise training (RET', 'vitamin D 3 supplementation', 'calcium and vitamin D', 'RET and placebo', 'placebo', 'vitamin D supplementation and resistance exercise training', 'exercise training alone', 'combined vitamin D 3 supplementation and resistance exercise training']","['lower limb extensor power output', 'musculoskeletal health', 'muscle power (Nottingham Power Rig), body composition (dual energy X-ray absorptiometry), muscle function (short physical performance battery, timed up and go), falls and fractures as events', 'musculoskeletal function']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0543431', 'cui_str': 'ret (qualifier value)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0587731', 'cui_str': 'Sheltered housing (environment)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0543431', 'cui_str': 'ret (qualifier value)'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C0231484', 'cui_str': 'Muscular activity'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0026861', 'cui_str': 'Musculoskeletal Physiological Concepts'}]",,0.294362,"Measures of muscle power (Nottingham Power Rig), body composition (dual energy X-ray absorptiometry), muscle function (short physical performance battery, timed up and go), falls and fractures as events will be assessed.","[{'ForeName': 'Anneka Elizabeth', 'Initials': 'AE', 'LastName': 'Welford', 'Affiliation': 'School of Sports, Exericse and Rehabilitation Sciences, University of Birmingham, Birmingham, UK aea423@bham.ac.uk.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Lanham-New', 'Affiliation': 'Department of Nutritional Sciences, University of Surrey, Surrey, UK.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Lord', 'Affiliation': 'MRC-Arthritis UK Centre for Musculoskeletal Ageing Research, University of Birmingham, Birmingham, West Midlands, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Doyle', 'Affiliation': 'The Royal Osteoporosis Society, Bath, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Robinson', 'Affiliation': 'Move it or Lose it, Birmingham, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nightingale', 'Affiliation': 'Wellcome Trust Clinical Research Facility, Queen Elizabeth Hospital Birmingham, Birmingham, West Midlands, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Gittoes', 'Affiliation': 'Centre for Endocrinology, Diabetes and Metabolism, Queen Elizabeth Hospital Birmingham, Birmingham, Birmingham, UK.'}, {'ForeName': 'Carolyn A', 'Initials': 'CA', 'LastName': 'Greig', 'Affiliation': 'MRC-Versus Arthritis Centre for Musculoskeletal Ageing Research, MRC-Arthritis Research UK Centre for Musculoskeletal Ageing Research, Birmingham, UK.'}]",BMJ open,['10.1136/bmjopen-2019-033824'] 226,32176761,Testing the Food Experience in Healthy Human Volunteers: a Proof-of-Concept Study.,"BACKGROUND AND AIMS For a healthy food to be introduced to the consumer's diet, it has to be attractive, yet testing for food acceptance and the sensory postprandial responses is still not standardized. The main objective of this study was to demonstrate that healthier foods can be obtained without impact on the responses to ingestion. METHODS A randomized, cross-over, double-blind, pilot study in non-obese, healthy men (n=8) comparing the responses to a standard sausage rich in animal fat (mortadella) versus a modified product based on a plant-derived fat analogue and an aroma. Palatability and postprandial sensations were measured on 10 cm scales and brain activity was evaluated by functional magnetic resonance imaging before and after each meal on separate days. RESULTS Both meals were rated equally palatable and induced the same degree of homeostatic sensations (satiety, fullness) with a similar hedonic dimension (improved mood and digestive well-being). Both meals induced similar changes in brain connectivity: decreased activity in the frontal-parietal, basal ganglia and thalamus, visual occipital, sensory-motor, temporal superior and in the ""default-mode"" networks, while increased activity was detected in the network associated with white matter. CONCLUSION A substantial improvement in the nutritional profile of food can be achieved without affecting the responses to ingestion.",2020,"Both meals induced similar changes in brain connectivity: decreased activity in the frontal-parietal, basal ganglia and thalamus, visual occipital, sensory-motor, temporal superior and in the ""default-mode"" networks, while increased activity was detected in the network associated with white matter. ","['Healthy Human Volunteers', 'non-obese, healthy men (n=8']",['standard sausage rich in animal fat (mortadella) versus a modified product based on a plant-derived fat analogue and an aroma'],"['Palatability and postprandial sensations', 'activity', 'homeostatic sensations (satiety, fullness', 'frontal-parietal, basal ganglia and thalamus, visual occipital, sensory-motor, temporal superior']","[{'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0452945', 'cui_str': 'Sausage (substance)'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0301429', 'cui_str': 'Animal fat (substance)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0360301', 'cui_str': 'Product base (product)'}, {'cui': 'C0032098', 'cui_str': 'Plants'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C2987717', 'cui_str': 'Aroma'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0442030', 'cui_str': 'Parietal (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0039729', 'cui_str': 'Thalamencephalon'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}]",,0.0519515,"Both meals induced similar changes in brain connectivity: decreased activity in the frontal-parietal, basal ganglia and thalamus, visual occipital, sensory-motor, temporal superior and in the ""default-mode"" networks, while increased activity was detected in the network associated with white matter. ","[{'ForeName': 'Teodora', 'Initials': 'T', 'LastName': 'Pribic', 'Affiliation': ""Digestive System Research Unit, University Hospital Vall d'Hebron; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (Ciberehd); Departament de Medicina, Universitat Autònoma de Barcelona, Spain. . teodora.pribic@gmail.com.""}, {'ForeName': 'Quiro', 'Initials': 'Q', 'LastName': 'Lopez', 'Affiliation': 'Grupo Carinsa, 08192 Sant Quirze del Vallès, Barcelona, Spain. quiro@carinsa.com.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Lucas', 'Affiliation': 'Grupo Carinsa, 08192 Sant Quirze del Vallès, Barcelona, Spain. elucas@carinsa.com.'}, {'ForeName': 'Dan M', 'Initials': 'DM', 'LastName': 'Livovsky', 'Affiliation': 'Digestive Diseases Institute Shaare Zedek Medical Center Lecturer Hebrew University Faculty of Medicine, Jerusalem, Israel.. danlivo@szmc.org.il.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Rovira', 'Affiliation': 'Digestive Diseases Institute; Shaare Zedek Medical Center, Hebrew University of Jerusalem, Israel. alex.rovira@idi.gencat.cat.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Accarino', 'Affiliation': ""Digestive System Research Unit, University Hospital Vall d'Hebron; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (Ciberehd); Departament de Medicina, Universitat Autònoma de Barcelona, Spain. aaccarino@telefonica.net.""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Azpiroz', 'Affiliation': ""Digestive System Research Unit, University Hospital Vall d'Hebron; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (Ciberehd); Departament de Medicina, Universitat Autònoma de Barcelona, Spain. azpiroz.fernando@gmail.com.""}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Pareto', 'Affiliation': ""Neuroradiology Section, Radiology Department, University Hospital Vall d'Hebron, Barcelona, Spain. deborah.pareto@idi.gencat.cat.""}]",Journal of gastrointestinal and liver diseases : JGLD,['10.15403/jgld-806'] 227,32152156,Safetxt: a safer sex intervention delivered by mobile phone messaging on sexually transmitted infections (STI) among young people in the UK - protocol for a randomised controlled trial.,"INTRODUCTION Young people aged 16 to 24 have the highest prevalence of genital chlamydia and gonorrhoea compared with other age groups and re-infection rates following treatment are high. Long-term adverse health effects include subfertility and ectopic pregnancy, particularly among those with repeated infections. We developed the safetxt intervention delivered by text message to reduce sexually transmitted infection (STI) by increasing partner notification, condom use and (STI) testing among young people in the UK. METHODS AND ANALYSIS A single-blind randomised trial to reliably establish the effect of the safetxt intervention on chlamydia and gonorrhoea infection at 1 year. We will recruit 6250 people aged 16 to 24 years who have recently been diagnosed with chlamydia, gonorrhoea or non-specific urethritis from health services in the UK. Participants will be allocated to receive the safetxt intervention (text messages designed to promote safer sexual health behaviours) or to receive the control text messages (monthly messages asking participants about changes in contact details) by an automated remote online randomisation system. The primary outcome will be the cumulative incidence of chlamydia and gonorrhoea infection at 1 year assessed by nucleic acid amplification tests. Secondary outcomes include partner notification, correct treatment of infection, condom use and STI testing prior to sex with new partners. ETHICS AND DISSEMINATION Ethics approval was obtained from NHS Health Research Authority - London - Riverside Research Ethics Committee (REC reference: 15/LO/1665) and the London School of Hygiene & Tropical Medicine. We will submit the results of the trial for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER International Standard Randomised Controlled Trials Number: ISRCTN64390461. Registered on 17 th March 2016. WHO trial registration data set available at: http://apps.who.int/trialsearch/Trial2.aspx?TrialID=ISRCTN64390461. TRIAL PROTOCOL VERSION 12, 19 th July 2018.",2020,"INTRODUCTION Young people aged 16 to 24 have the highest prevalence of genital chlamydia and gonorrhoea compared with other age groups and re-infection rates following treatment are high.","['Young people aged 16 to 24', '12, 19 th July 2018', 'young people in the UK', '6250 people aged 16 to 24 years who have recently been diagnosed with chlamydia, gonorrhoea or non-specific urethritis from health services in the UK']","['safetxt intervention delivered by text message to reduce sexually transmitted infection (STI) by increasing partner notification, condom use and (STI) testing', 'safetxt intervention', 'safetxt intervention (text messages designed to promote safer sexual health behaviours) or to receive the control text messages (monthly messages asking participants about changes in contact details) by an automated remote online randomisation system', 'mobile phone messaging']","['partner notification, correct treatment of infection, condom use and STI testing prior to sex with new partners', 'cumulative incidence of chlamydia and gonorrhoea infection at 1 year assessed by nucleic acid amplification tests', 'chlamydia and gonorrhoea infection']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0018081', 'cui_str': 'Neisseria gonorrhoeae Infection'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0041976', 'cui_str': 'Urethritis'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0079990', 'cui_str': 'Notification, Partner'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1136360', 'cui_str': 'Mobile Phone'}]","[{'cui': 'C0079990', 'cui_str': 'Notification, Partner'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0018081', 'cui_str': 'Neisseria gonorrhoeae Infection'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0200932', 'cui_str': 'Nucleic Acid Amplification Tests'}]",6250.0,0.307453,"INTRODUCTION Young people aged 16 to 24 have the highest prevalence of genital chlamydia and gonorrhoea compared with other age groups and re-infection rates following treatment are high.","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Free', 'Affiliation': 'Population Health, London School of Hygiene and Tropical Medicine, London, London, UK caroline.free@lshtm.ac.uk.'}, {'ForeName': 'Ona L', 'Initials': 'OL', 'LastName': 'McCarthy', 'Affiliation': 'Population Health, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Melissa J', 'Initials': 'MJ', 'LastName': 'Palmer', 'Affiliation': 'Population Health, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Knight', 'Affiliation': 'Clinical Trials Unit, MSD, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Edwards', 'Affiliation': 'Population Health, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'French', 'Affiliation': 'Social and Environmental Health Research, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Baraitser', 'Affiliation': ""Centre for Global Health, King's College London, London, London, UK.""}, {'ForeName': 'Ford Colin Ian', 'Initials': 'FCI', 'LastName': 'Hickson', 'Affiliation': 'Sigma Research, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Kaye', 'Initials': 'K', 'LastName': 'Wellings', 'Affiliation': 'Social and Environmental Health Research, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Roberts', 'Affiliation': 'Population Health, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Julia V', 'Initials': 'JV', 'LastName': 'Bailey', 'Affiliation': 'Primary Care and Population Health, University College London, London, London, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Hart', 'Affiliation': 'Department of Infection and Population Health, University College London, London, London, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Michie', 'Affiliation': 'Centre for Outcomes Research and Effectivenes, University College London, London, London, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Clayton', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'George B', 'Initials': 'GB', 'LastName': 'Ploubidis', 'Affiliation': 'Department of Social Science, University College London Institute of Education, London, London, UK.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Carpenter', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Katy M E', 'Initials': 'KME', 'LastName': 'Turner', 'Affiliation': 'Bristol Vetinary School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Devries', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Potter', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, London, UK.'}]",BMJ open,['10.1136/bmjopen-2019-031635'] 228,32194987,"A single-centre investigator-blinded randomised parallel-group study protocol to investigate the influence of an acclimatisation appointment on children's behaviour during N 2 O/O 2 sedation as measured by psychological, behavioural and real-time physiological parameters.","Aims and objectives To describe a study protocol of a randomised control trial (RCT) assessing the effectiveness, in reducing dental anxiety, of an acclimatising nitrous oxide sedation (N 2 O) session prior to actual dental treatment with N 2 O. Materials and methods A single-centre investigator-blinded parallel-group RCT conducted in a postgraduate dental hospital in Dubai, United Arab Emirates (UAE). Anxious children requiring N 2 O (aged 5-15 years) will be randomly assigned to; a study group: children who will have a preparatory N 2 O trial experience or; a control group: children who will only have N 2 O explained to them. Treatment with N 2 O for both groups will start at the second visit. The following outcomes will be recorded: completion of dental treatment, anxiety scores at baseline and after treatment (using the Modified Child Dental Anxiety Scale faces), behaviour of the child (using Frankl Rating Behaviour Scale) and the acquisition of real-time physiological anxiety-related parameters (using E4 ® electronic wrist devices). Results The data will be analysed statistically. Discussion There is a paucity of research regarding dental N 2 O acclimatising appointments. This RCT will supplement existing literature. Conclusions This RCT will report whether prior acclimatising of a child to N 2 O sedation is effective, or not, in improving dental treatment behaviour.",2020,"behaviour of the child (using Frankl Rating Behaviour Scale) and the acquisition of real-time physiological anxiety-related parameters (using E4 ® electronic wrist devices). ","['Anxious children requiring N 2 O (aged 5-15 years', 'conducted in a postgraduate dental hospital in Dubai, United Arab Emirates (UAE']","['nitrous oxide sedation (N 2 O) session prior to actual dental treatment with N 2 O.\nMaterials and methods\n\n\nA single-centre investigator-blinded parallel-group RCT', 'acclimatisation appointment']","['completion of dental treatment, anxiety scores', 'behaviour of the child (using Frankl Rating Behaviour Scale']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C3164440', 'cui_str': 'Dental hospital'}, {'cui': 'C0282540', 'cui_str': 'Arabs'}]","[{'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0011331', 'cui_str': 'Dental Care'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]","[{'cui': 'C0011331', 'cui_str': 'Dental Care'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0222045'}]",,0.1265,"behaviour of the child (using Frankl Rating Behaviour Scale) and the acquisition of real-time physiological anxiety-related parameters (using E4 ® electronic wrist devices). ","[{'ForeName': 'Mawlood', 'Initials': 'M', 'LastName': 'Kowash', 'Affiliation': 'Hamdan Bin Mohammed College of Dental Medicine, Mohammed Bin Rashid University of Medicine & Health Sciences, Dubai, United Arab Emirates.'}, {'ForeName': 'Manal', 'Initials': 'M', 'LastName': 'Al-Halabi', 'Affiliation': 'Hamdan Bin Mohammed College of Dental Medicine, Mohammed Bin Rashid University of Medicine & Health Sciences, Dubai, United Arab Emirates.'}, {'ForeName': 'Iyad', 'Initials': 'I', 'LastName': 'Hussein', 'Affiliation': 'Hamdan Bin Mohammed College of Dental Medicine, Mohammed Bin Rashid University of Medicine & Health Sciences, Dubai, United Arab Emirates.'}, {'ForeName': 'Mohammad M', 'Initials': 'MM', 'LastName': 'Abdo', 'Affiliation': 'Hamdan Bin Mohammed College of Dental Medicine, Mohammed Bin Rashid University of Medicine & Health Sciences, Dubai, United Arab Emirates.'}, {'ForeName': 'Anas', 'Initials': 'A', 'LastName': 'Salami', 'Affiliation': 'Hamdan Bin Mohammed College of Dental Medicine, Mohammed Bin Rashid University of Medicine & Health Sciences, Dubai, United Arab Emirates.'}, {'ForeName': 'Amar', 'Initials': 'A', 'LastName': 'Hassan', 'Affiliation': 'Hamdan Bin Mohammed College of Dental Medicine, Mohammed Bin Rashid University of Medicine & Health Sciences, Dubai, United Arab Emirates.'}, {'ForeName': 'Yrsa', 'Initials': 'Y', 'LastName': 'Sverrisdottir', 'Affiliation': 'College of Medicine, Mohammed Bin Rashid University of Medicine and Health Sciences, Dubai, United Arab Emirates.'}, {'ForeName': 'Jinous F', 'Initials': 'JF', 'LastName': 'Tahmassebi', 'Affiliation': '3Leeds School of Dentistry, Leeds University, Leeds, UK.'}]",BDJ open,['10.1038/s41405-020-0031-y'] 229,24794367,Effect of fluconazole prophylaxis on candidiasis and mortality in premature infants: a randomized clinical trial.,"IMPORTANCE Invasive candidiasis in premature infants causes death and neurodevelopmental impairment. Fluconazole prophylaxis reduces candidiasis, but its effect on mortality and the safety of fluconazole are unknown. OBJECTIVE To evaluate the efficacy and safety of fluconazole in preventing death or invasive candidiasis in extremely low-birth-weight infants. DESIGN, SETTING, AND PATIENTS This study was a randomized, blinded, placebo-controlled trial of fluconazole in premature infants. Infants weighing less than 750 g at birth (N = 361) from 32 neonatal intensive care units (NICUs) in the United States were randomly assigned to receive either fluconazole or placebo twice weekly for 42 days. Surviving infants were evaluated at 18 to 22 months corrected age for neurodevelopmental outcomes. The study was conducted between November 2008 and February 2013. INTERVENTIONS Fluconazole (6 mg/kg of body weight) or placebo. MAIN OUTCOMES AND MEASURES The primary end point was a composite of death or definite or probable invasive candidiasis prior to study day 49 (1 week after completion of study drug). Secondary and safety outcomes included invasive candidiasis, liver function, bacterial infection, length of stay, intracranial hemorrhage, periventricular leukomalacia, chronic lung disease, patent ductus arteriosus requiring surgery, retinopathy of prematurity requiring surgery, necrotizing enterocolitis, spontaneous intestinal perforation, and neurodevelopmental outcomes-defined as a Bayley-III cognition composite score of less than 70, blindness, deafness, or cerebral palsy at 18 to 22 months corrected age. RESULTS Among infants receiving fluconazole, the composite primary end point of death or invasive candidiasis was 16% (95% CI, 11%-22%) vs 21% in the placebo group (95% CI, 15%-28%; odds ratio, 0.73 [95% CI, 0.43-1.23]; P = .24; treatment difference, -5% [95% CI, -13% to 3%]). Invasive candidiasis occurred less frequently in the fluconazole group (3% [95% CI, 1%-6%]) vs the placebo group (9% [95% CI, 5%-14%]; P = .02; treatment difference, -6% [95% CI, -11% to -1%]). The cumulative incidences of other secondary outcomes were not statistically different between groups. Neurodevelopmental impairment did not differ between the groups (fluconazole, 31% [95% CI, 21%-41%] vs placebo, 27% [95% CI, 18%-37%]; P = .60; treatment difference, 4% [95% CI, -10% to 17%]). CONCLUSIONS AND RELEVANCE Among infants with a birth weight of less than 750 g, 42 days of fluconazole prophylaxis compared with placebo did not result in a lower incidence of the composite of death or invasive candidiasis. These findings do not support the universal use of prophylactic fluconazole in extremely low-birth-weight infants. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00734539.",2014,"Neurodevelopmental impairment did not differ between the groups (fluconazole, 31% [95% CI, 21%-41%] vs placebo, 27% [95% CI, 18%-37%]; P = .60; treatment difference, 4% [95% CI, -10% to 17%]). ","['Infants weighing less than 750 g at birth (N\u2009=\u2009361) from 32 neonatal intensive care units (NICUs) in the United States', 'extremely low-birth-weight infants', 'infants with a birth weight of less than 750 g, 42 days of', 'premature infants', 'November 2008 and February 2013']","['placebo', 'fluconazole or placebo', 'fluconazole', 'prophylactic fluconazole', 'Fluconazole prophylaxis', 'fluconazole prophylaxis', 'Fluconazole']","['cumulative incidences', 'invasive candidiasis, liver function, bacterial infection, length of stay, intracranial hemorrhage, periventricular leukomalacia, chronic lung disease, patent ductus arteriosus requiring surgery, retinopathy of prematurity requiring surgery, necrotizing enterocolitis, spontaneous intestinal perforation, and neurodevelopmental outcomes-defined as a Bayley-III cognition composite score of less than 70, blindness, deafness, or cerebral palsy', 'composite of death or definite or probable invasive candidiasis', 'Invasive candidiasis', 'efficacy and safety', 'candidiasis and mortality', 'Neurodevelopmental impairment', 'composite of death or invasive candidiasis', 'death or invasive candidiasis']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0456065', 'cui_str': 'Infant, Extremely Low Birth Weight'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0004623', 'cui_str': 'Bacterial Infections'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}, {'cui': 'C0023529', 'cui_str': 'Encephalomalacia, Periventricular'}, {'cui': 'C0746102', 'cui_str': 'Chronic lung disease'}, {'cui': 'C3495549', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0035344', 'cui_str': 'Retrolental Fibroplasia'}, {'cui': 'C0520459', 'cui_str': 'Necrotizing Enterocolitis'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0021845', 'cui_str': 'Intestinal Perforation'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]",,0.60973,"Neurodevelopmental impairment did not differ between the groups (fluconazole, 31% [95% CI, 21%-41%] vs placebo, 27% [95% CI, 18%-37%]; P = .60; treatment difference, 4% [95% CI, -10% to 17%]). ","[{'ForeName': 'Daniel K', 'Initials': 'DK', 'LastName': 'Benjamin', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Hudak', 'Affiliation': 'University of Florida College of Medicine-Jacksonville.'}, {'ForeName': 'Shahnaz', 'Initials': 'S', 'LastName': 'Duara', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Randolph', 'Affiliation': 'University of Alabama-Birmingham.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Bidegain', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Gratias T', 'Initials': 'GT', 'LastName': 'Mundakel', 'Affiliation': 'Kings County Hospital, Brooklyn, New York.'}, {'ForeName': 'Girija', 'Initials': 'G', 'LastName': 'Natarajan', 'Affiliation': 'Wayne State University, Detroit, Michigan.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Burchfield', 'Affiliation': 'University of Florida Health Shands Hospital, Gainesville.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'White', 'Affiliation': 'Memorial Hospital South Bend, South Bend, Indiana.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Shattuck', 'Affiliation': 'University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Neu', 'Affiliation': 'Columbia University, New York, New York.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Bendel', 'Affiliation': ""University of Minnesota Amplatz Children's Hospital, Minneapolis.""}, {'ForeName': 'M Roger', 'Initials': 'MR', 'LastName': 'Kim', 'Affiliation': 'Brookdale University Hospital, Brooklyn, New York.'}, {'ForeName': 'Neil N', 'Initials': 'NN', 'LastName': 'Finer', 'Affiliation': 'University of California-San Diego Medical Center.'}, {'ForeName': 'Dan L', 'Initials': 'DL', 'LastName': 'Stewart', 'Affiliation': 'University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Arrieta', 'Affiliation': ""Children's Hospital of Orange County, Orange, California.""}, {'ForeName': 'Kelly C', 'Initials': 'KC', 'LastName': 'Wade', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kaufman', 'Affiliation': 'University of Virginia, Charlottesville.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Manzoni', 'Affiliation': ""Sant'Anna Hospital, Turin, Italy.""}, {'ForeName': 'Kristi O', 'Initials': 'KO', 'LastName': 'Prather', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Testoni', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Katherine Y', 'Initials': 'KY', 'LastName': 'Berezny', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'P Brian', 'Initials': 'PB', 'LastName': 'Smith', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2014.2624'] 230,32201375,Four-year outcomes of small incision lenticule extraction (SMILE) to correct high myopic astigmatism.,"AIMS To evaluate the long-term outcomes of small incision lenticule extraction (SMILE) in subjects with myopic astigmatism of ≥2.00 dioptres (D). METHODS Patients who underwent SMILE 4 years prior with astigmatism ≥2.00 D and ≤1.00 D were assigned to the high astigmatic group (HA group) or the low astigmatic group (LA group), respectively. The visual and refractive results as well as corneal wavefront aberrations were measured. RESULTS The preoperative cylinder was -2.47±0.54 D in 43 eyes in the HA group and -0.55±0.28 D in 31 eyes in the LA group. At 4 years, the residual cylinder was -0.31±0.29 D in the HA group and -0.20±0.28 D in the LA group (p=0.088). An uncorrected distance visual acuity of 20/20 was achieved in 88.4% of eyes in the HA group and 93.5% of eyes in the LA group. The efficacy index was 0.99±0.14 and 1.10±0.21 (p=0.025), and the safety index was 1.11±0.20 and 1.22±0.21 in the HA and LA groups, respectively (p=0.012). Eighty-six per cent and 90.3% of eyes were within ±0.50 D of the attempted cylindrical correction in the HA and LA groups, respectively. Vector analysis showed that the magnitude of error was -0.14±0.28 D and -0.05±0.16 D (p=0.085), the angle of error was -0.13±4.48 degrees and -2.57±29.42 degrees (p=0.592), the correction index was 0.94±0.13 and 0.94±0.35 (p=0.959), the index of success was 0.15±0.14 and 0.46±0.62 (p=0.517), and the flattening index was 0.93±0.13 and 0.71±0.59 (p=0.450) in the HA and LA groups, respectively. CONCLUSIONS This study demonstrates that SMILE is effective and safe for correcting high astigmatism. Vector analysis shows a tendency for the undercorrection of astigmatism in subjects with high astigmatism.",2021,An uncorrected distance visual acuity of 20/20 was achieved in 88.4% of eyes in the HA group and 93.5% of eyes in the LA group.,"['Patients who underwent SMILE 4 years prior with astigmatism ≥2.00 D and ≤1.00 D', '43 eyes in the HA group and -0.55±0.28 D in 31 eyes in the LA group', 'subjects with high astigmatism', 'subjects with myopic astigmatism of ≥2.00 dioptres (D']","['small incision lenticule extraction (SMILE', 'SMILE', 'high astigmatic group (HA group) or the low astigmatic group (LA']","['efficacy index', 'index of success', 'safety index', 'correction index', 'flattening index', 'corneal wavefront aberrations', 'uncorrected distance visual acuity', 'residual cylinder']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037363', 'cui_str': 'Smilings'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3839737', 'cui_str': 'High astigmatism'}, {'cui': 'C2363771', 'cui_str': 'Myopic astigmatism'}, {'cui': 'C0439486', 'cui_str': 'Diopters - (qualifier value)'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0037363', 'cui_str': 'Smilings'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2717990', 'cui_str': 'Corneal Wavefront Aberration'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C4319645', 'cui_str': 'Cylinder (unit of presentation)'}]",,0.0481363,An uncorrected distance visual acuity of 20/20 was achieved in 88.4% of eyes in the HA group and 93.5% of eyes in the LA group.,"[{'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zhong', 'Affiliation': 'The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology, Eye, Ear, Nose and Throat Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Han', 'Affiliation': 'Department of Ophthalmology, Eye, Ear, Nose and Throat Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Fu', 'Affiliation': 'Department of Ophthalmology, Eye, Ear, Nose and Throat Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Xingtao', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Ophthalmology, Eye, Ear, Nose and Throat Hospital, Fudan University, Shanghai, China doctzhouxingtao@163.com.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2019-315619'] 231,32201400,Effect of Dietary Nori (Dried Laver) on Blood Pressure in Young Japanese Children: An Intervention Study.,"BACKGROUND Few studies have examined the association between seaweed intake and blood pressure in children. We conducted an intervention study to investigate whether seaweed intake affects blood pressure. METHODS Subjects were children aged 4 to 5 years attending a preschool in Aichi Prefecture, Japan, in 2010. Among 99 students, 89 (89.9%) were enrolled in our study. Nori (dried laver), an edible seaweed widely consumed in Japan, was used as a dietary intervention. Children in the intervention group were asked to consume 1.76 grams per day of roasted nori in addition to standard meals for 10 weeks. Children in the control group consumed their usual diet. Before the intervention and at the 10th week of the intervention, children's blood pressure was measured three times successively using an automated sphygmomanometer with subjects in a sitting position. Changes in systolic (SBP) and diastolic blood pressure (DBP) were compared between 55 children in the intervention group and 26 in the control group after adjustment for SBP and DBP before the intervention. RESULTS Changes in SBP were -8.29 mm Hg in the intervention group and +0.50 mm Hg in the control group (P for difference in change = 0.051). Changes in DBP were -6.77 mm Hg in the intervention group and -0.05 mm Hg in the control group (P = 0.031). In girls, no difference in blood pressure changes was found between the intervention and control groups. CONCLUSION Nori intake lowered DBP level in boys. Seaweed intake might have preventive effects on elevated blood pressure in childhood.",2021,Changes in DBP were -6.77 mmHg in the intervention group and -0.05 mmHg in the control group (p = 0.031).,"['99 students, 89 (89.9%) were enrolled in our study', 'Subjects were children aged 4 to 5 years attending a preschool in Aichi Prefecture, Japan, in 2010', 'children', 'young Japanese children']",['dietary nori (dried laver'],"['SBP', 'Changes in systolic (SBP) and diastolic blood pressure (DBP', 'blood pressure', 'blood pressure changes', 'Changes in DBP', 'DBP level', 'elevated blood pressure']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}]","[{'cui': 'C1257934', 'cui_str': 'Nori'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}]","[{'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0497247', 'cui_str': 'Finding of increased blood pressure (finding)'}]",,0.0175932,Changes in DBP were -6.77 mmHg in the intervention group and -0.05 mmHg in the control group (p = 0.031).,"[{'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Wada', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Gifu University Graduate School of Medicine.'}, {'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Tsuji', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Gifu University Graduate School of Medicine.'}, {'ForeName': 'Kozue', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Gifu University Graduate School of Medicine.'}, {'ForeName': 'Shino', 'Initials': 'S', 'LastName': 'Oba', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Gifu University Graduate School of Medicine.'}, {'ForeName': 'Sakiko', 'Initials': 'S', 'LastName': 'Nishizawa', 'Affiliation': ""Department of Food and Culture Science, Aichi Bunkyo Women's College.""}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': ""Department of Food and Culture Science, Aichi Bunkyo Women's College.""}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': ""Department of Food and Culture Science, Aichi Bunkyo Women's College.""}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Ando', 'Affiliation': ""Department of Food and Culture Science, Aichi Bunkyo Women's College.""}, {'ForeName': 'Chisato', 'Initials': 'C', 'LastName': 'Nagata', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Gifu University Graduate School of Medicine.'}]",Journal of epidemiology,['10.2188/jea.JE20190176'] 232,31838622,Magnesium and Ketamine Reduce Early Morphine Consumption After Open Bariatric Surgery: a Prospective Randomized Double-Blind Study.,"BACKGROUNDS Optimal pain management in bariatric patients is crucial for early recovery. This study aims to evaluate the effects of magnesium and ketamine combination on morphine consumption after open bariatric surgery (primary outcome), as well as on postoperative pain scores and occurrence of side effects. METHOD A total of 60 patients undergoing elective open gastric bypass were randomized into 3 groups. All patients received the same general anaesthesia protocol. The magnesium and ketamine group (Mg + K) received an IV bolus of magnesium 50 mg/kg and ketamine 0.2 mg/kg followed by continuous infusion of magnesium (8 mg/kg/h) and ketamine (0.15 mg/kg/h) until extubation. The ketamine group (K) received the same bolus and infusion of ketamine, together with a bolus and continuous infusion of normal saline. The placebo group (P) received normal saline. All patients received 48 h of paracetamol 1 g IV q6h and morphine sulphate 0.1 mg/kg subcutaneous q6h PRN. Morphine consumption, VAS pain scores and occurrence of side effects were recorded for 48 h postoperatively. RESULTS Patients in group (Mg + K) (2.4 ± 2.62 mg) and in group (K) (2.8 ± 2.66 mg) had significantly lower morphine consumption in the PACU compared with the patients in group (P) (4.85 ± 4.51 mg) (p = 0.045). Patients in group (Mg + K) consumed significantly less morphine the first 24 postoperative hours, with a relative reduction of 87% and 21% compared with group (K) and group (P) respectively (p = 0.028). However, this difference was not observed at 48 h. No significant difference was shown between the three groups in terms of nausea and vomiting, time to extubation or excessive sedation. CONCLUSION The association of magnesium and ketamine bolus followed by infusion in open bariatric surgery appears to be safe and decreases morphine requirements in the first 24 h compared with both ketamine alone and placebo.",2020,"No significant difference was shown between the three groups in terms of nausea and vomiting, time to extubation or excessive sedation. ","['60 patients undergoing elective open gastric bypass', 'bariatric patients']","['magnesium and ketamine group (Mg + K', 'Magnesium and Ketamine', 'placebo', 'morphine', 'ketamine', 'ketamine alone and placebo', 'Morphine Consumption', 'ketamine, together with a bolus and continuous infusion of normal saline', 'normal saline', 'paracetamol 1\xa0g IV q6h and morphine sulphate 0.1\xa0mg/kg subcutaneous q6h PRN', 'magnesium and ketamine', 'magnesium and ketamine combination', 'magnesium 50\xa0mg/kg and ketamine 0.2\xa0mg/kg followed by continuous infusion of magnesium']","['morphine consumption', 'Morphine consumption, VAS pain scores and occurrence of side effects', 'nausea and vomiting, time to extubation or excessive sedation', 'morphine requirements', 'postoperative pain scores and occurrence of side effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}]","[{'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1278442', 'cui_str': 'Continuous infusion of normal saline'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0066814', 'cui_str': 'Morphine Sulfate'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0558288', 'cui_str': 'prn'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion (qualifier value)'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.31751,"No significant difference was shown between the three groups in terms of nausea and vomiting, time to extubation or excessive sedation. ","[{'ForeName': 'Hicham', 'Initials': 'H', 'LastName': 'Jabbour', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Management, Hôtel-Dieu de France Hospital, Saint Joseph University School of Medicine, P.O. Box 11-5076, Beirut, 1107 2180, Lebanon.'}, {'ForeName': 'Khalil', 'Initials': 'K', 'LastName': 'Jabbour', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Management, Hôtel-Dieu de France Hospital, Saint Joseph University School of Medicine, P.O. Box 11-5076, Beirut, 1107 2180, Lebanon.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Abi Lutfallah', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Management, Hôtel-Dieu de France Hospital, Saint Joseph University School of Medicine, P.O. Box 11-5076, Beirut, 1107 2180, Lebanon. Antoine.abilutfallah@net.usj.edu.lb.'}, {'ForeName': 'Hicham', 'Initials': 'H', 'LastName': 'Abou Zeid', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Management, Hôtel-Dieu de France Hospital, Saint Joseph University School of Medicine, P.O. Box 11-5076, Beirut, 1107 2180, Lebanon.'}, {'ForeName': 'Eliane', 'Initials': 'E', 'LastName': 'Nasser-Ayoub', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Management, Hôtel-Dieu de France Hospital, Saint Joseph University School of Medicine, P.O. Box 11-5076, Beirut, 1107 2180, Lebanon.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Abou Haidar', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Management, Hôtel-Dieu de France Hospital, Saint Joseph University School of Medicine, P.O. Box 11-5076, Beirut, 1107 2180, Lebanon.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Naccache', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Management, Hôtel-Dieu de France Hospital, Saint Joseph University School of Medicine, P.O. Box 11-5076, Beirut, 1107 2180, Lebanon.'}]",Obesity surgery,['10.1007/s11695-019-04317-1'] 233,32185662,Plecanatide Is Effective and Safe in the Treatment for Chronic Idiopathic Constipation: Results of a Phase II Trial.,"BACKGROUND Many patients with chronic idiopathic constipation (CIC) remain unsatisfied with their treatment options. Plecanatide is a pH-sensitive uroguanylin analog that increases fluid and ion movement into the gastrointestinal lumen, softening stools and encouraging motility, while limiting the risk of diarrhea. AIMS The objective of this phase 2 study is to evaluate the safety and efficacy of once-daily oral plecanatide in patients with CIC and identify the most effective dose. METHODS A 12-week, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study was conducted in patients aged 18-75 years and diagnosed with CIC based on modified Rome III criteria (< 3 complete spontaneous bowel movements [CSBMs] per week and infrequent loose stools without the use of laxatives). Participants were randomized to placebo or plecanatide 0.3, 1.0, or 3.0 mg. The primary efficacy endpoint was the proportion of overall CSBM responders. Key secondary endpoints included time to first CSBM, change in CSBM and spontaneous bowel movement (SBM) frequency rates, patient-reported outcomes, safety, and tolerability. RESULTS Of 951 randomized participants, 946 were included in the modified intent-to-treat population. Plecanatide 0.3 and 3.0 mg significantly increased overall CSBM responder rates compared with placebo (0.3 mg, P = 0.016; 3.0 mg, P = 0.009). Plecanatide was associated with decreased time to first CSBM, significant increases in CSBM and SBM frequency, and decreased patient-reported constipation severity compared with placebo. Diarrhea was the most frequently reported treatment-emergent adverse event. CONCLUSIONS Plecanatide is a well-tolerated treatment that relieved the symptoms of CIC with a relatively low incidence of diarrhea.",2021,"Plecanatide 0.3 and 3.0 mg significantly increased overall CSBM responder rates compared with placebo (0.3 mg, P = 0.016; 3.0 mg, P = 0.009).","['patients aged 18-75\xa0years and diagnosed with CIC based on modified Rome III criteria (<\u20093 complete spontaneous bowel movements [CSBMs] per week and infrequent loose stools without the use of laxatives', 'patients with chronic idiopathic constipation (CIC', 'Chronic Idiopathic Constipation', 'patients with CIC', '951 randomized participants']","['Plecanatide', 'placebo', 'placebo or plecanatide']","['time to first CSBM, change in CSBM and spontaneous bowel movement (SBM) frequency rates, patient-reported outcomes, safety, and tolerability', 'proportion of overall CSBM responders', 'overall CSBM responder rates', 'Diarrhea', 'CSBM and SBM frequency', 'constipation severity', 'safety and efficacy', 'time to first CSBM']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0521114', 'cui_str': 'Infrequent (qualifier value)'}, {'cui': 'C2129214', 'cui_str': 'Loose stool (finding)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0282090', 'cui_str': 'Laxatives'}, {'cui': 'C0267509', 'cui_str': 'Chronic idiopathic constipation (disorder)'}]","[{'cui': 'C3711911', 'cui_str': 'plecanatide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",951.0,0.238032,"Plecanatide 0.3 and 3.0 mg significantly increased overall CSBM responder rates compared with placebo (0.3 mg, P = 0.016; 3.0 mg, P = 0.009).","[{'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Barish', 'Affiliation': 'Wake Gastroenterology, Raleigh, NC, USA.'}, {'ForeName': 'Spencer', 'Initials': 'S', 'LastName': 'Dorn', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Ronald P', 'Initials': 'RP', 'LastName': 'Fogel', 'Affiliation': 'Digestive Health Center of Michigan, Chesterfield, MI, USA.'}, {'ForeName': 'Reema', 'Initials': 'R', 'LastName': 'Patel', 'Affiliation': 'Bausch Health US, LLC, 400 Somerset Corporate Blvd., Bridgewater Township, NJ, 08807, USA. Reema.Patel@Bauschhealth.com.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Rosenberg', 'Affiliation': 'Illinois Gastroenterology Group, Gurnee, IL, USA.'}]",Digestive diseases and sciences,['10.1007/s10620-020-06187-5'] 234,32178787,Comparison of the effect of manual compression and closure pad on postangiography complications: A randomized controlled trial.,"BACKGROUND Different methods are available for the closure of the femoral artery after catheterization. The present study aimed at comparing the effect of manual compression (MC) and closure pad (CP) on vascular complications (hematoma and bleeding) of coronary angiography. METHODS In the current clinical trial, a total of 238 patients who were candidates for angiography were randomly assigned to the MC and CP groups. In the MC group, after removal of the arterial sheath, the arterial puncture site was manually compressed for 5-10 minutes and hemostasis was achieved. In the CP group, after removal of the arterial sheath, the arterial puncture site was first manually compressed for 5-10 minutes and initial coagulation was achieved. Then, to continue the coagulation process, a CP was attached to the artery puncture site. Postangiography complications including bleeding and hematoma were monitored in both groups immediately and up to 24 hours after hemostasis. Data were analyzed by SPSS-18 software. RESULTS After angiography, 7 (9.5%) and 5 (2.4%) patients had hematoma in the MC and CP groups, respectively; however, no significant difference was found between the groups. Rebleeding after hemostasis was observed in 2 (7.1%) patients in the MC group, but none of the subjects in the CP group had rebleeding. There was no significant difference in bleeding volume between the groups. CONCLUSION The results indicated the same efficacy of MC and CP methods in the prevention of postangiography vascular complications. Given the advantages of CP such as the possibility of changing the position in bed and increased physical comfort in the patient, this method is recommended for angiography and catheterization.",2020,"There was no significant difference in bleeding volume between the groups. ",['238 patients who were candidates for angiography'],"['manual compression (MC) and closure pad (CP', 'MC and CP', 'manual compression and closure pad']","['bleeding volume', 'rebleeding', 'postangiography complications', 'bleeding and hematoma', 'Rebleeding after hemostasis', 'hematoma', 'vascular complications (hematoma and bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}]",238.0,0.0604766,"There was no significant difference in bleeding volume between the groups. ","[{'ForeName': 'Shahriar', 'Initials': 'S', 'LastName': 'Moeinian', 'Affiliation': 'Critical Care Nursing, Student Research Committee, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Nesa', 'Initials': 'N', 'LastName': 'Cheraghbeigi', 'Affiliation': 'Medical Surgical Nursing, Clinical Research Development Center, Imam Reza Hospital, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Aghaei', 'Affiliation': 'Social Determinants of Health Research Center, Research Institute for Health Development, Kurdistan University of Medical Sciences, Sanandaj, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Bahremand', 'Affiliation': 'Clinical Research Development Center, Imam Ali Hospital, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Khatony', 'Affiliation': 'Health Institute, Social Development and Health Promotion Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran. Electronic address: Akhatony@gmail.com.'}]",Journal of vascular nursing : official publication of the Society for Peripheral Vascular Nursing,['10.1016/j.jvn.2020.01.001'] 235,32169923,Standardised self-management kits for children with type 1 diabetes: pragmatic randomised trial of effectiveness and cost-effectiveness.,"OBJECTIVE To estimate the effectiveness of standardised self-management kits for children with type 1 diabetes. DESIGN Pragmatic trial with randomisation ratio of two intervention: one control. Qualitative process evaluation. SETTING 11 diabetes clinics in England and Wales. PARTICIPANTS Between February 2010 and August 2011, we validly randomised 308 children aged 6-18 years; 201 received the intervention. INTERVENTION We designed kits to empower children to achieve glycaemic control, notably by recording blood glucose and titrating insulin. The comparator was usual treatment. OUTCOME MEASURES AT 3 AND 6 MONTHS: Primary: Diabetes Pediatric Quality of Life Inventory (PedsQL). Secondary: HbA1c; General PedsQL; EQ-5D; healthcare resource use. RESULTS Of the five Diabetes PedsQL dimensions, Worry showed adjusted scores significantly favouring self-management kits at 3 months (mean child-reported difference =+5.87; Standard error[SE]=2.19; 95% confidence interval [CI]) from +1.57 to +10.18; p=0.008); but Treatment Adherence significantly favoured controls at 6 months (mean child-reported difference=-4.68; SE=1.74; 95%CI from -8.10 to -1.25; p=0.008). Intervention children reported significantly worse changes between 3 and 6 months on four of the five Diabetes PedsQL dimensions and on the total score (mean difference=-3.20; SE=1.33; 95% CI from -5.73 to -0.67; p=0.020). There was no evidence of change in HbA1c; only 18% of participants in each group achieved recommended levels at 6 months. No serious adverse reactions attributable to the intervention or its absence were reported.Use of kits was poor. Few children or parents associated blood glucose readings with better glycaemic control. The kits, costing £185, alienated many children and parents. CONCLUSIONS Standardised kits showed no evidence of benefit, inhibited diabetes self-management and increased worry. Future research should study relationships between children and professionals, and seek new methods of helping children and parents to manage diabetes. TRIAL REGISTRATION NUMBER ISRCTN17551624.",2020,Intervention children reported significantly worse changes between 3 and 6 months on four of the five Diabetes PedsQL dimensions and on the total score (mean difference=-3.20; SE=1.33; 95% CI from -5.73 to -0.67; p=0.020).,"['Of the five Diabetes PedsQL dimensions', 'children with type 1 diabetes', '11 diabetes clinics in England and Wales', 'Between February 2010 and August 2011, we validly randomised 308 children aged 6-18 years; 201 received the intervention']","['standardised self-management kits', 'Standardised self-management kits']","['serious adverse reactions', 'total score', 'change in HbA1c', 'Diabetes Pediatric Quality of Life Inventory (PedsQL', 'blood glucose readings']","[{'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C1690540', 'cui_str': 'Kit'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0034380'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}]",308.0,0.115808,Intervention children reported significantly worse changes between 3 and 6 months on four of the five Diabetes PedsQL dimensions and on the total score (mean difference=-3.20; SE=1.33; 95% CI from -5.73 to -0.67; p=0.020).,"[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Noyes', 'Affiliation': 'School of Health Sciences, Bangor University, Bangor, UK jane.noyes@bangor.ac.uk.'}, {'ForeName': 'Davina', 'Initials': 'D', 'LastName': 'Allen', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Carter', 'Affiliation': 'School of Journalism, Media and Culture, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Edwards', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Rhiannon Tudor', 'Initials': 'RT', 'LastName': 'Edwards', 'Affiliation': 'Centre for Health Economics and Medicines Management Evaluation, School of Health Sciences, Bangor University, Bangor, UK.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Russell', 'Affiliation': 'Swansea University Medical School, Swansea University, Swansea, UK.'}, {'ForeName': 'Ian T', 'Initials': 'IT', 'LastName': 'Russell', 'Affiliation': 'Swansea University Medical School, Swansea University, Swansea, UK.'}, {'ForeName': 'Llinos Haf', 'Initials': 'LH', 'LastName': 'Spencer', 'Affiliation': 'Centre for Health Economics and Medicines Management Evaluation, School of Health Sciences, Bangor University, Bangor, UK.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Sylvestre', 'Affiliation': 'Manchester Academic Health Science (MAHSC) Clinical Trials Unit, Christie Hospital NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Rhiannon', 'Initials': 'R', 'LastName': 'Whitaker', 'Affiliation': 'Whitaker Research Limited, Rhos on Sea, North Wales, UK.'}, {'ForeName': 'Seow Tien', 'Initials': 'ST', 'LastName': 'Yeo', 'Affiliation': 'Centre for Health Economics and Medicines Management Evaluation, School of Health Sciences, Bangor University, Bangor, UK.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Gregory', 'Affiliation': 'Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, UK.'}]",BMJ open,['10.1136/bmjopen-2019-032163'] 236,32169925,Assessing the effect of closed-loop insulin delivery from onset of type 1 diabetes in youth on residual beta-cell function compared to standard insulin therapy (CLOuD study): a randomised parallel study protocol.,"INTRODUCTION Management of newly diagnosed type 1 diabetes (T1D) in children and adolescents is challenging for patients, families and healthcare professionals. The objective of this study is to determine whether continued intensive metabolic control using hybrid closed-loop (CL) insulin delivery following diagnosis of T1D can preserve C-peptide secretion, a marker of residual beta-cell function, compared with standard multiple daily injections (MDI) therapy. METHODS AND ANALYSIS The study adopts an open-label, multicentre, randomised, parallel design, and aims to randomise 96 participants aged 10-16.9 years, recruited within 21 days of diagnosis with T1D. Following a baseline mixed meal tolerance test (MMTT), participants will be randomised to receive 24 months treatment with conventional MDI therapy or with CL insulin delivery. A further 24-month optional extension phase will be offered to all participants to continue with the allocated treatment. The primary outcome is the between group difference in area under the stimulated C-peptide curve (AUC) of the MMTT at 12 months post diagnosis. Analyses will be conducted on an intention-to-treat basis. Key secondary outcomes are between group differences in time spent in target glucose range (3.9-10 mmol/L), glycated haemoglobin (HbA1c) and time spent in hypoglycaemia (<3.9 mmol/L) at 12 months. Secondary efficacy outcomes include between group differences in stimulated C-peptide AUC at 24 months, time spent in target glucose range, glucose variability, hypoglycaemia and hyperglycaemia as recorded by periodically applied masked continuous glucose monitoring devices, total, basal and bolus insulin dose, and change in body weight. Cognitive, emotional and behavioural characteristics of participants and parents will be evaluated, and a cost-utility analysis performed to support adoption of CL as a standard treatment modality following diagnosis of T1D. ETHICS AND DISSEMINATION Ethics approval has been obtained from Cambridge East Research Ethics Committee. The results will be disseminated by peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER NCT02871089; Pre-results.",2020,"Secondary efficacy outcomes include between group differences in stimulated C-peptide AUC at 24 months, time spent in target glucose range, glucose variability, hypoglycaemia and hyperglycaemia as recorded by periodically applied masked continuous glucose monitoring devices, total, basal and bolus insulin dose, and change in body weight.","['96 participants aged 10-16.9 years, recruited within 21 days of diagnosis with T1D. Following a']","['closed-loop insulin delivery', 'conventional MDI therapy or with CL insulin delivery', 'hybrid closed-loop (CL) insulin delivery', 'standard insulin therapy', 'baseline mixed meal tolerance test (MMTT']","['glycated haemoglobin (HbA1c) and time spent in hypoglycaemia', 'area under the stimulated C-peptide curve (AUC', 'Cognitive, emotional and behavioural characteristics', 'time spent in target glucose range', 'stimulated C-peptide AUC at 24 months, time spent in target glucose range, glucose variability, hypoglycaemia and hyperglycaemia as recorded by periodically applied masked continuous glucose monitoring devices, total, basal and bolus insulin dose, and change in body weight']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0201777', 'cui_str': 'Tolerance test (procedure)'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0332182', 'cui_str': 'Periodic (qualifier value)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",96.0,0.230446,"Secondary efficacy outcomes include between group differences in stimulated C-peptide AUC at 24 months, time spent in target glucose range, glucose variability, hypoglycaemia and hyperglycaemia as recorded by periodically applied masked continuous glucose monitoring devices, total, basal and bolus insulin dose, and change in body weight.","[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Boughton', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Allen', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Tauschmann', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Hartnell', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Malgorzata E', 'Initials': 'ME', 'LastName': 'Wilinska', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Musolino', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Carlo L', 'Initials': 'CL', 'LastName': 'Acerini', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Professor David', 'Initials': 'PD', 'LastName': 'Dunger', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Campbell', 'Affiliation': ""Children's Diabetes Centre, Leeds Children's Hospital, Leeds, UK.""}, {'ForeName': 'Atrayee', 'Initials': 'A', 'LastName': 'Ghatak', 'Affiliation': ""Department of Diabetes, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'Tabitha', 'Initials': 'T', 'LastName': 'Randell', 'Affiliation': ""Department of Paediatric Diabetes and Endocrinology, Nottingham Children's Hospital, Nottingham, UK.""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Besser', 'Affiliation': 'NIHR Oxford Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Trevelyan', 'Affiliation': ""Paediatric Diabetes, Southampton Children's Hospital, Southampton, UK.""}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Elleri', 'Affiliation': 'Department of Diabetes, Royal Hospital for Sick Children, Edinburgh, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Northam', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Korey', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Endocrinology, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Scott', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Lawton', 'Affiliation': 'The University of Edinburgh Usher Institute of Population Health Sciences and Informatics, Edinburgh, UK.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Roze', 'Affiliation': 'HEVA HEOR Sarl, Lyon, France.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Sibayan', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Kollman', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'Nate', 'Initials': 'N', 'LastName': 'Cohen', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Todd', 'Affiliation': 'Wellcome Trust Centre for Human Genetics, Oxford, UK.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hovorka', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK rh347@cam.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-033500'] 237,32179560,Pediatric Adenotonsillectomy Trial for Snoring (PATS): protocol for a randomised controlled trial to evaluate the effect of adenotonsillectomy in treating mild obstructive sleep-disordered breathing.,"INTRODUCTION Mild obstructive sleep-disordered breathing (oSDB), characterised by habitual snoring without frequent apnoeas and hypopnoeas on polysomnography, is prevalent in children and commonly treated with adenotonsillectomy (AT). However, the absence of high-level evidence addressing the role of AT in improving health and behavioural outcomes has contributed to significant geographical variations in care and potential for surgery to be both overused and underused. METHODS AND ANALYSIS The Pediatric Adenotonsillectomy Trial for Snoring (PATS) is a single-blinded, multicentre randomised controlled trial designed to evaluate the effect of AT in treating mild oSDB. Four hundred sixty eligible children, aged 3.0-12.9 years old, will be randomised to either early adenotonsillectomy or to watchful waiting with supportive care (WWSC) with a 1:1 ratio. The study's coprimary endpoints are (1) change from baseline in executive behaviour relating to self-regulation and organisation skills as measured by the Behavioural Rating Inventory of Executive Function (BRIEF) Global Composite Score (GEC); and (2) change from baseline in vigilance as measured on the Go-No-Go (GNG) signal detection parameter (d-prime). A mixed effects model will be used to compare changes in the BRIEF GEC score and GNG score at 6 and 12 months from baseline between the AT arm and the WWSC arm. ETHICS AND DISSEMINATION The study protocol was approved by the institutional review board (IRB) at Children's Hospital of Philadelphia (CHOP) on 3 October 2014 (14-0 11 214). The approval of CHOP as the central IRB of record was granted on 29 February 2016. The results will be published in peer-reviewed journals and presented at academic conferences. The data collected from the PATS study will be deposited in a repository (National Sleep Research Resource, sleepdata.org) after completion of the study to maximise use by the scientific community. TRIAL REGISTRATION NUMBER NCT02562040; Pre-results.",2020,Global Composite Score (GEC); and (2) change from baseline in vigilance as measured on the Go-No-Go (GNG) signal detection parameter (d-prime).,"[""Children's Hospital of Philadelphia (CHOP) on 3 October 2014 (14-0 11 214"", 'Pediatric Adenotonsillectomy Trial for Snoring (PATS', 'Four hundred sixty eligible children, aged 3.0-12.9 years old', 'mild obstructive sleep-disordered breathing']","['early adenotonsillectomy or to watchful waiting with supportive care (WWSC', 'Mild obstructive sleep-disordered breathing (oSDB', 'adenotonsillectomy']","['executive behaviour relating to self-regulation and organisation skills as measured by the Behavioural Rating Inventory of Executive Function (BRIEF', 'Global Composite Score (GEC); and (2) change from baseline in vigilance as measured on the Go-No-Go (GNG) signal detection parameter', 'BRIEF GEC score and GNG score']","[{'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy (procedure)'}, {'cui': 'C0037384', 'cui_str': 'Snorings'}, {'cui': 'C0030587', 'cui_str': 'Paroxysmal atrial tachycardia (disorder)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy (procedure)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}]","[{'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection Analysis'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",460.0,0.222773,Global Composite Score (GEC); and (2) change from baseline in vigilance as measured on the Go-No-Go (GNG) signal detection parameter (d-prime).,"[{'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, Massachusetts, USA rwang@hsph.harvard.edu.'}, {'ForeName': 'Jessie P', 'Initials': 'JP', 'LastName': 'Bakker', 'Affiliation': ""Division of Sleep Medicine and Circadian Disorders, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Ronald D', 'Initials': 'RD', 'LastName': 'Chervin', 'Affiliation': 'Sleep Disorders Center and Department of Neurology, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Garetz', 'Affiliation': 'Sleep Disorders Center and Department of Otolaryngology-Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Fauziya', 'Initials': 'F', 'LastName': 'Hassan', 'Affiliation': 'Sleep Disorders Center and Division of Pediatric Pulmonology, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Stacey L', 'Initials': 'SL', 'LastName': 'Ishman', 'Affiliation': ""Divisions of Otolaryngology-Head and Neck Surgery and Pulmonary Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}, {'ForeName': 'Ron B', 'Initials': 'RB', 'LastName': 'Mitchell', 'Affiliation': ""Department of Otolaryngology, Head and Neck Surgery, UT Southwestern and Children's Medical Center Dallas, Dallas, Texas, USA.""}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Morrical', 'Affiliation': ""Division of Sleep Medicine and Circadian Disorders, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Syed K', 'Initials': 'SK', 'LastName': 'Naqvi', 'Affiliation': ""Department of Otolaryngology, Head and Neck Surgery, UT Southwestern and Children's Medical Center Dallas, Dallas, Texas, USA.""}, {'ForeName': 'Jerilynn', 'Initials': 'J', 'LastName': 'Radcliffe', 'Affiliation': 'Department of Pediatrics, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Emily I', 'Initials': 'EI', 'LastName': 'Riggan', 'Affiliation': 'Department of Otolaryngology, Eastern Virginia Medical School, Norfolk, Virginia, USA.'}, {'ForeName': 'Carol L', 'Initials': 'CL', 'LastName': 'Rosen', 'Affiliation': ""Department of Pediatrics, University Hospitals Rainbow Babies and Children's Hospital, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.""}, {'ForeName': 'Kristie', 'Initials': 'K', 'LastName': 'Ross', 'Affiliation': ""Department of Pediatrics, University Hospitals Rainbow Babies and Children's Hospital, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rueschman', 'Affiliation': ""Division of Sleep Medicine and Circadian Disorders, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Ignacio E', 'Initials': 'IE', 'LastName': 'Tapia', 'Affiliation': 'Department of Pediatrics, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'H Gerry', 'Initials': 'HG', 'LastName': 'Taylor', 'Affiliation': ""Department of Pediatrics, University Hospitals Rainbow Babies and Children's Hospital, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Zopf', 'Affiliation': 'Sleep Disorders Center and Department of Otolaryngology-Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Redline', 'Affiliation': ""Division of Sleep Medicine and Circadian Disorders, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}]",BMJ open,['10.1136/bmjopen-2019-033889'] 238,31858394,"Randomized, Double-Blind Study of the Effect of Intraoperative Intravenous Lidocaine on the Opioid Consumption and Criteria for Hospital Discharge After Bariatric Surgery.","BACKGROUND AND OBJECTIVES Surgical trauma, pain and opioids can cause nausea, vomiting, ileus and increased length of hospital stay. The primary objective of the study was to evaluate the time to recovery of gastrointestinal function and the time to meet hospital discharge criteria after laparoscopic bariatric surgery with intraoperative intravenous lidocaine administration. Secondary objectives were to evaluate morphine consumption during the first 24 h and the side effects of opioids. METHODS Fifty-eight patients aged 18 to 60 years who underwent bariatric surgery were allocated into two groups. Group 1 patients received intravenous lidocaine (1.5 mg/kg) 5 min before induction of anaesthesia, followed by infusion (2 mg/kg/h) until the end of surgery. Group 2 patients were given 0.9% saline solution (placebo) and infusion of 0.9% saline solution during surgery, in same volume as group 1. Anaesthesia was performed with fentanyl (5 μg/kg), propofol (2 mg/kg), rocuronium (0.6 mg/kg) and sevoflurane. Postoperative patient-controlled analgesia was with morphine. There were two groups that were evaluated: time to recovery of gastrointestinal function and time to meet discharge criteria. RESULTS There was no significant difference between groups regarding the time to first flatus, time to meet discharge criteria and occurrence of side effects. Consumption of intraoperative sevoflurane and morphine over 24 h was significantly lower in the lidocaine group. Side effects observed were nausea and vomiting, with no difference between groups. CONCLUSIONS Perioperative intravenous lidocaine is feasible and easily accessible when administered at appropriate doses. Lidocaine reduces morphine consumption.",2020,"There was no significant difference between groups regarding the time to first flatus, time to meet discharge criteria and occurrence of side effects.",['Fifty-eight patients aged 18 to 60\xa0years who underwent bariatric surgery'],"['morphine', 'saline solution (placebo) and infusion of 0.9% saline solution', 'fentanyl', 'rocuronium', 'propofol', 'intraoperative sevoflurane and morphine', 'Intraoperative Intravenous Lidocaine', 'laparoscopic bariatric surgery with intraoperative intravenous lidocaine', 'Lidocaine', 'lidocaine', 'sevoflurane', 'intravenous lidocaine']","['nausea, vomiting, ileus and increased length of hospital stay', 'morphine consumption during the first 24\xa0h and the side effects of opioids', 'nausea and vomiting', 'time to first flatus, time to meet discharge criteria and occurrence of side effects', 'morphine consumption', 'Opioid Consumption and Criteria for Hospital Discharge', 'time to recovery of gastrointestinal function and time to meet discharge criteria']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C1258215', 'cui_str': 'Ileus'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",58.0,0.50095,"There was no significant difference between groups regarding the time to first flatus, time to meet discharge criteria and occurrence of side effects.","[{'ForeName': 'Rioko K', 'Initials': 'RK', 'LastName': 'Sakata', 'Affiliation': 'Universidade Federal de São Paulo, Rua Botucatu, São Paulo, 593, Brazil. rsakata@unifesp.br.'}, {'ForeName': 'Roclides C', 'Initials': 'RC', 'LastName': 'de Lima', 'Affiliation': 'São Domingos Hospital, São Luis, Brazil.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Valadão', 'Affiliation': 'São Domingos Hospital, São Luis, Brazil.'}, {'ForeName': 'Plinio C', 'Initials': 'PC', 'LastName': 'Leal', 'Affiliation': 'Universidade Federal do Maranhão, São Luis, Brazil.'}, {'ForeName': 'Ed Cr', 'Initials': 'EC', 'LastName': 'Moura', 'Affiliation': 'Universidade Federal do Maranhão, São Luis, Brazil.'}, {'ForeName': 'Vitor P', 'Initials': 'VP', 'LastName': 'Cruz', 'Affiliation': 'Universidade Federal do Maranhão, São Luis, Brazil.'}, {'ForeName': 'Caio Mb', 'Initials': 'CM', 'LastName': 'de Oliveira', 'Affiliation': 'Universidade Federal do Maranhão, São Luis, Brazil.'}]",Obesity surgery,['10.1007/s11695-019-04340-2'] 239,32181569,Antithrombotic regimens for percutaneous coronary intervention of the left main coronary artery: The EXCEL trial.,"OBJECTIVES We compared the effect of bivalirudin or heparin and use or nonuse of glycoprotein IIb/IIIa inhibitors (GPI) on the outcome of left main coronary artery (LMCA) percutaneous coronary intervention (PCI) in the randomized EXCEL trial. BACKGROUND The optimal antithrombotic regimen to support PCI of the LMCA remains controversial because of low representation of this subset in clinical trials. METHODS The PCI cohort (n = 928) in EXCEL was divided according to bivalirudin versus heparin antithrombin treatment and compared for the primary composite endpoint of death, myocardial infarction (MI), or stroke at 30 days and 5 years. RESULTS Bivalirudin was used in 319 patients (34.4%). The composite endpoint at 30 days occurred in 7.2% versus 3.8% bivalirudin and heparin patients, respectively, p = .02; at 5 years, the composite endpoint occurred in 26.3% versus 19.9% bivalirudin and heparin patients, respectively, p = .02. Major bleeding was more frequent in bivalirudin patients (4.1% versus 1.3%, p = .008). There were no differences in stent thrombosis between the groups. Bivalirudin use was an independent predictor of the 30-day composite endpoint (OR 2.88, 95% CI 1.28-6.48, p = .01) but not of the 5-year composite endpoint (OR 1.30, 95% CI 0.84-2.02, p = .23). GPI use was infrequent (n = 67, 7.2%) and was not associated with adverse outcomes. CONCLUSION Among patients undergoing LMCA PCI in the EXCEL trial, procedural use of bivalirudin was associated with greater rates of periprocedural MI and the 30-day composite endpoint without reducing bleeding complications. Five-year outcomes were similar. GPIs were used infrequently and were not associated with clinical outcomes.",2021,"Major bleeding was more frequent in bivalirudin patients (4.1% versus 1.3%, p = .008).","['percutaneous coronary intervention of the left main coronary artery', 'patients undergoing LMCA PCI in the EXCEL trial', '319 patients (34.4']","['Antithrombotic regimens', 'bivalirudin versus heparin antithrombin', 'Bivalirudin', 'heparin', 'bivalirudin or heparin', 'glycoprotein IIb/IIIa inhibitors (GPI', 'bivalirudin']","['bleeding complications', 'composite endpoint', '30-day composite endpoint', 'rates of periprocedural MI', 'GPI use', 'death, myocardial infarction (MI), or stroke', 'Major bleeding', 'stent thrombosis', '5-year composite endpoint ']","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2740529', 'cui_str': 'Excel'}]","[{'cui': 'C0168273', 'cui_str': 'bivalirudin'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0003440', 'cui_str': 'Direct Thrombin Inhibitors'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",928.0,0.208498,"Major bleeding was more frequent in bivalirudin patients (4.1% versus 1.3%, p = .008).","[{'ForeName': 'Sorin J', 'Initials': 'SJ', 'LastName': 'Brener', 'Affiliation': 'NewYork-Presbyterian Brooklyn Methodist Hospital, New York, New York, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Lembo', 'Affiliation': 'Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kandzari', 'Affiliation': 'Piedmont Heart Institute, Atlanta, Georgia.'}, {'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Sabaté', 'Affiliation': ""University Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Anthony H', 'Initials': 'AH', 'LastName': 'Gershlick', 'Affiliation': 'University Hospitals of Leicester, Leicester, UK.'}, {'ForeName': 'Adrian P', 'Initials': 'AP', 'LastName': 'Banning', 'Affiliation': 'John Radcliffe Hospital, Oxford, UK.'}, {'ForeName': 'Paweł E', 'Initials': 'PE', 'LastName': 'Buszman', 'Affiliation': 'Department of Epidemiology and Statistics, Medical School of Silesia, Katowice, Poland.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Kosmidou', 'Affiliation': 'Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York, USA.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Simonton', 'Affiliation': 'Abbott Vascular, Santa Clara, California, USA.'}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Morice', 'Affiliation': 'Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France.'}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Ben-Yehuda', 'Affiliation': 'Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York, USA.'}, {'ForeName': 'Ovidiu', 'Initials': 'O', 'LastName': 'Dressler', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA.'}, {'ForeName': 'Zixuan', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Sabik', 'Affiliation': 'Department of Surgery, UH Cleveland Medical Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Arie Pieter', 'Initials': 'AP', 'LastName': 'Kappetein', 'Affiliation': 'Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Imperial College of Science, Technology and Medicine, London, UK.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28858'] 240,32057673,Replacing HMG/FSH by low-dose HCG to complete corifollitropin alfa stimulation reduces cost per clinical pregnancy: a randomized pragmatic trial.,"RESEARCH QUESTION The cost of IVF treatment remains high, among other factors because of the medication needed for ovarian stimulation. This study investigated the effect of using low-dose human chorionic gonadotrophin (HCG) for the second phase of follicular maturation after corifollitropin alfa induction, to replace the more expensive, either recombinant or human menopausal gonadotrophin (HMG), on the cost of ovarian stimulation. DESIGN One hundred and five patients were randomly divided into two groups: patients in the HCG group (n = 50) received low-dose HCG from Day 7 until the diameter of at least three follicles reached 17 mm or more, while patients in the FSH group (n = 55) received conventional ovarian stimulation with highly purified HMG injections. RESULTS The clinical pregnancy rate in the HCG group was 38% higher than in the FSH group (number needed to treat, NNT = 13). The cost per pregnancy needed for ovarian stimulation was reduced from €4902 in the FSH group to €2684 in the HCG group. Hence, the cost of ovarian stimulation medication to obtain 10 pregnancies using the conventional FSH protocol is sufficient to attain 18 pregnancies when applying the low-dose HCG protocol. CONCLUSION This study provides evidence that using HCG instead of HMG/FSH for ovarian stimulation results in a significant reduction in the cost of IVF with, at least, an equivalent pregnancy rate.",2020,The cost per pregnancy needed for ovarian stimulation was reduced from €4902 in the FSH group to €2684 in the HCG group.,['One hundred and five patients'],"['HCG', 'low-dose HCG', 'FSH', 'recombinant or human menopausal gonadotrophin (HMG', 'conventional FSH protocol', 'low-dose human chorionic gonadotrophin (HCG', 'conventional ovarian stimulation with highly purified HMG injections']","['cost of IVF', 'cost per clinical pregnancy', 'cost per pregnancy needed for ovarian stimulation', 'clinical pregnancy rate']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1141639', 'cui_str': 'Human Chorionic Gonadotropin'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0025326', 'cui_str': 'Gonadotropins, Human Menopausal'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}]",105.0,0.0762078,The cost per pregnancy needed for ovarian stimulation was reduced from €4902 in the FSH group to €2684 in the HCG group.,"[{'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Decleer', 'Affiliation': 'Fertility Clinic, Weststraat 16-18, Aalter 9880, Belgium; IVF Center, AZ Jan Palfijn Gent, Watersportlaan 5, Gent 9000, Belgium. Electronic address: dokter@dokterdecleer.com.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Comhaire', 'Affiliation': 'Fertility Clinic, Weststraat 16-18, Aalter 9880, Belgium.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Balduyck', 'Affiliation': 'KU Leuven, Oude Markt 13, Leuven 3000, Belgium.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Ameye', 'Affiliation': 'KU Leuven, Oude Markt 13, Leuven 3000, Belgium.'}, {'ForeName': 'Kaan', 'Initials': 'K', 'LastName': 'Osmanagaoglu', 'Affiliation': 'IVF Center, AZ Jan Palfijn Gent, Watersportlaan 5, Gent 9000, Belgium.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Devroey', 'Affiliation': 'Fertility Clinic, Weststraat 16-18, Aalter 9880, Belgium; Center for Reproductive Medicine, UZ Brussel, Laarbeeklaan 101, Jette 1090, Belgium.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2019.10.008'] 241,31845082,One Anastomosis Gastric Bypass Performed with a 150-cm Biliopancreatic Limb Delivers Weight Loss Outcomes Similar to Those with a 200-cm Biliopancreatic Limb at 18 -24 Months.,"BACKGROUND It has been suggested that shortening the biliopancreatic limb (BPL) length with one anastomosis gastric bypass (OAGB) to 150 cm would reduce the revision rates for malnutrition. But, it remains unclear if this would not compromise the efficacy of this procedure. METHODS We examined our prospectively maintained database to compare the outcomes of patients who had their OAGB performed with a 150-cm BPL with those performed with a 200-cm BPL. RESULTS Medium-term weight loss data at 18-24 months was available for 343/398 (86.1% follow-up) patients. Of these, 225 had undergone OAGB-200 and 118 had undergone OAGB-150. The mean preoperative weight and body mass index were 141.6 ± 32.8 kg and 49.76 ± 8.6 kg/m 2 , respectively, in the OAGB-200 group compared with 133.7 ± 24.5 kg and 47.83 ± 7.2 kg/m 2 , respectively, in the OAGB-150 group. There was no significant difference in albumin and haemoglobin levels in the two groups at 18-month follow-up. The mean excess weight loss was 75.0% ± 20.1 in the OAGB-200 group and 74.0% ± 22.0 in the OAGB-150 group (p = 0.6714). A total of 89.7% (n = 202) patients achieved an excess weight loss (EWL) of ≥ 50.0% in the OAGB-200 group compared with 85.5% (n = 103) in the OAGB-150 group (p value = 0.4754). The mean total weight loss was 36.1% ± 9.2 in the OAGB-200 group compared with 34.0% ± 9.8 in the OAGB-150 group (p value = 0.0598). CONCLUSIONS OAGB performed with a BPL of 150 cm delivers weight loss outcomes similar to that seen with a BPL of 200 cm.",2020,There was no significant difference in albumin and haemoglobin levels in the two groups at 18-month follow-up.,['patients who had their OAGB performed with a 150-cm BPL with those performed with a 200-cm BPL'],[],"['excess weight loss (EWL', 'mean preoperative weight and body mass index', 'mean excess weight loss', 'albumin and haemoglobin levels', 'mean total weight loss']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0050286', 'cui_str': 'A 150 (plastic)'}]",[],"[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.05313,There was no significant difference in albumin and haemoglobin levels in the two groups at 18-month follow-up.,"[{'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Boyle', 'Affiliation': 'Bariatric Unit, Sunderland Royal Hospital, Sunderland, SR4 7TP, UK.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Mahawar', 'Affiliation': 'Bariatric Unit, Sunderland Royal Hospital, Sunderland, SR4 7TP, UK. kamal_mahawar@hotmail.com.'}]",Obesity surgery,['10.1007/s11695-019-04359-5'] 242,32141825,Analysis of correlation between liver fat fraction and AST and ALT levels in overweight and obese children by using new magnetic resonance imaging technique.,"BACKGROUND/AIMS Proton density fat fraction (PDFF) magnetic resonance (MR) imaging can be a useful technique for volumetric measurements of liver fat. The purpose of our study was to evaluate the correlation between liver fat fraction (LFF) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels in children who are overweight and obese. MATERIALS AND METHODS Overall, 25 children, aged 9-17 years, were included. Patients with a body mass index (BMI) z-score between 85-95th percentile (12 of 25 patients) were assigned to the overweight group, and those with BMI z-score above 95th percentile (13 of 25 patients) were assigned to the obese group. The control group comprised 12 healthy children with BMI z-score below 85th percentile. Liver fat fraction measurements were performed on 3D volume measurement workstation by using PDFF magnetic resonance (MR) images. Spearman's correlation coefficients between liver fat fraction and AST and ALT levels were evaluated individually for overweight, obese, and control groups. Receiver operator characteristics (ROC) analysis was also performed. RESULTS In the overweight and obese groups, the liver proton density fat fraction and AST levels had a strong correlation (r=0.716, p<0.001). In addition, the LFF and ALT levels demonstrated a strong correlation (r=0.878, p<0.001). ROC analysis ascertained an optimal liver fat fraction threshold of 114 for predicting AST level (sensitivity=75%, specificity=89%). ROC analysis ascertained an optimal LFF threshold of 114 for predicting ALT level (sensitivity=80%, specificity=90%). CONCLUSION Our results indicate a strong correlation between LFF values and AST and ALT levels in children who are overweight and obese.",2020,"In the overweight and obese groups, the liver proton density fat fraction and AST levels had a strong correlation (r=0.716, p<0.001).","['12 healthy children with BMI z-score below 85th percentile', 'children who are overweight and obese', 'Patients with a body mass index (BMI) z-score between 85-95th percentile (12 of 25 patients) were assigned to the overweight group, and those with BMI z-score above 95th percentile (13 of 25 patients) were assigned to the obese group', 'overweight and obese children', 'Overall, 25 children, aged 9-17 years, were included']",['Proton density fat fraction (PDFF) magnetic resonance'],"['liver fat fraction and AST and ALT levels', 'LFF and ALT levels', 'liver proton density fat fraction and AST levels', 'liver fat fraction (LFF) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels', 'LFF values and AST and ALT levels']","[{'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0033727', 'cui_str': 'Hydrogen Ions'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}]","[{'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0033727', 'cui_str': 'Hydrogen Ions'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",12.0,0.053732,"In the overweight and obese groups, the liver proton density fat fraction and AST levels had a strong correlation (r=0.716, p<0.001).","[{'ForeName': 'Berhan', 'Initials': 'B', 'LastName': 'Pirimoğlu', 'Affiliation': 'Department of Radiology, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Recep', 'Initials': 'R', 'LastName': 'Sade', 'Affiliation': 'Department of Radiology, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Gökhan', 'Initials': 'G', 'LastName': 'Polat', 'Affiliation': 'Department of Radiology, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'İşlek', 'Affiliation': 'Department of Pediatric Gastroenterology and Nutrition, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Mecit', 'Initials': 'M', 'LastName': 'Kantarcı', 'Affiliation': 'Department of Radiology, Ataturk University School of Medicine, Erzurum, Turkey.'}]",The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology,['10.5152/tjg.2020.18594'] 243,32170551,SERPINE-1 Gene Methylation and Protein as Molecular Predictors of Laparoscopic Sleeve Gastrectomy Outcome.,"BACKGROUND Body weight is subjected to genetic and epigenetic modifiers that might affect the success of weight loss interventions. Because of its possible complications and disparity in patients' response, identification of predictors to the outcome of bariatric surgery is indispensable. OBJECTIVES This prospective study aims to investigate serpin peptidase inhibitor type 1 (SERPINE-1) protein and gene methylation as molecular predictors to the outcome of bariatric surgery. PATIENTS AND METHODS One hundred participants were enrolled and divided to control group (n = 50) and obese patients who underwent laparoscopic sleeve gastrectomy (LSG) (n = 50). Anthropometric measurements were assessed and blood samples were collected preoperatively and 6 months postoperatively for assessment of SERPINE-1 protein and gene methylation, C-reactive protein (CRP), and homeostatic model assessment of insulin resistance (HOMA-IR). Moreover, subjects were followed for 2 years for weight loss parameters. RESULTS Patients with obesity showed high baseline SERPINE-1 protein and gene hypermethylation where LSG was followed by a drop in SERPINE-1 protein level but not gene hypermethylation. Baseline SERPINE-1 gene methylation was negatively related to postoperative weight loss and was the independent predictor to weight loss after LSG. Likewise, postoperative SERPINE-1 protein was negatively related to weight loss with independent expression from its gene methylation state. Furthermore, postoperative SERPINE-1 gene methylation correlated to CRP and HOMA-IR. CONCLUSION Baseline SERPINE-1 gene methylation might be a predictor of weight loss after LSG. Meanwhile, postoperative SERPINE-1 protein could be a predictor to weight loss maintenance after LSG. Lastly, postoperative SERPINE-1 gene methylation might serve as an index to postoperative changes in obesity-related comorbidities.",2020,Baseline SERPINE-1 gene methylation was negatively related to postoperative weight loss and was the independent predictor to weight loss after LSG.,['One hundred participants were enrolled and divided to control group (n\u2009=\u200950) and obese patients who underwent'],['laparoscopic sleeve gastrectomy (LSG'],"['weight loss', 'protein and gene methylation, C-reactive protein (CRP), and homeostatic model assessment of insulin resistance (HOMA-IR', 'postoperative weight loss']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",100.0,0.0189398,Baseline SERPINE-1 gene methylation was negatively related to postoperative weight loss and was the independent predictor to weight loss after LSG.,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Assem', 'Affiliation': 'Department of Medical Biochemistry, Faculty of Medicine, University of Alexandria, Alexandria, Egypt.'}, {'ForeName': 'Tamer N', 'Initials': 'TN', 'LastName': 'Abdelbaki', 'Affiliation': 'Department of Surgery, Faculty of Medicine, University of Alexandria, Alexandria, Egypt.'}, {'ForeName': 'Safaa H', 'Initials': 'SH', 'LastName': 'Mohy-El Dine', 'Affiliation': 'Department of Medical Biochemistry, Faculty of Medicine, University of Alexandria, Alexandria, Egypt.'}, {'ForeName': 'Amel F', 'Initials': 'AF', 'LastName': 'Ketat', 'Affiliation': 'Department of Medical Biochemistry, Faculty of Medicine, University of Alexandria, Alexandria, Egypt.'}, {'ForeName': 'Doaa A', 'Initials': 'DA', 'LastName': 'Abdelmonsif', 'Affiliation': 'Department of Medical Biochemistry, Faculty of Medicine, University of Alexandria, Alexandria, Egypt. doaa.elmonsif@alexmed.edu.eg.'}]",Obesity surgery,['10.1007/s11695-020-04533-0'] 244,32170552,The Prognostic Value of the Dutch Sweet Eating Questionnaire on Weight Loss After Metabolic Surgery: a Randomized Controlled Trial.,"BACKGROUND Laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (LSG) have shown different weight loss results. These differences might be partly due to dumping after LRYGB, forcing sweet eaters to switch to a healthy diet. The Dutch Sweet Eating Questionnaire (DSEQ) is validated to measure sweet eating. This study aims to investigate if sweet eating measured with the DSEQ influences weight loss. METHODS In this multicenter randomized controlled trial, patients were included between 2013 and 2017 in two Dutch high-volume hospitals, and randomized with a 1:1 ratio between LRYGB and LSG. Primary outcome measure was weight loss. Secondary outcome measure was sweet eating behavior, measured with the DSEQ. Data was collected at baseline, 1 year and 2 years postoperatively. RESULTS Data was analyzed of 623 patients who underwent LRYGB (n = 308; 49.4%) or LSG (n = 315; 50.6%). Follow-up rates at 2 years postoperative were 67.1% for weight and 35.3% for DSEQ. At 2 years postoperative, mean BMI was significantly higher after LSG than LRYGB (respectively 30.88 versus 28.87 kg/m 2 , p < 0.001), and the percentage of sweet eaters was significantly higher after LSG than LRYGB (respectively 8.6% versus 2.6%, p = 0.049). None of the preoperative sweet eaters were sweet eaters 2 years after LRYGB (0.0%), versus 11.8% 2 years after LSG. No correlation was found between postoperative sweet eating behavior and %EBMIL. CONCLUSION No significant correlation was found between preoperative or postoperative sweet eating measured with the DSEQ and weight loss. The decision-making for the procedure type is more complex than weight loss and dietary habits, and should also involve quality of life and presence of comorbidities. These factors should be addressed in future research along with longer term results. TRIAL REGISTRATION Dutch Trial Register NTR-4741.",2020,"At 2 years postoperative, mean BMI was significantly higher after LSG than LRYGB (respectively 30.88 versus 28.87 kg/m 2 , p < 0.001), and the percentage of sweet eaters was significantly higher after LSG than LRYGB (respectively 8.6% versus 2.6%, p = 0.049).","['patients were included between 2013 and 2017 in two Dutch high-volume hospitals, and randomized with a 1:1 ratio between LRYGB and LSG', '623 patients who underwent LRYGB (n\u2009=\u2009308; 49.4%) or']","['LSG', 'Laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (LSG']","['preoperative or postoperative sweet eating', 'weight loss', 'sweet eating behavior, measured with the DSEQ', 'DSEQ and weight loss', 'Weight Loss', 'postoperative sweet eating behavior and %EBMIL', 'mean BMI', 'percentage of sweet eaters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C3494218', 'cui_str': 'Hospitals, High-Volume'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]","[{'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.124103,"At 2 years postoperative, mean BMI was significantly higher after LSG than LRYGB (respectively 30.88 versus 28.87 kg/m 2 , p < 0.001), and the percentage of sweet eaters was significantly higher after LSG than LRYGB (respectively 8.6% versus 2.6%, p = 0.049).","[{'ForeName': 'L U', 'Initials': 'LU', 'LastName': 'Biter', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045 PM, Rotterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Leeman', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045 PM, Rotterdam, The Netherlands. M.Leeman@Franciscus.nl.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Friskes', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045 PM, Rotterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'der Kinderen', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045 PM, Rotterdam, The Netherlands.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Apers', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045 PM, Rotterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dunkelgrun', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045 PM, Rotterdam, The Netherlands.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Zengerink', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045 PM, Rotterdam, The Netherlands.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Smulders', 'Affiliation': 'Department of Surgery, Catharina Hospital, Eindhoven, The Netherlands.'}]",Obesity surgery,['10.1007/s11695-020-04527-y'] 245,32170307,A randomized controlled trial of CBT-I and PAP for obstructive sleep apnea and comorbid insomnia: main outcomes from the MATRICS study.,"STUDY OBJECTIVES To investigate treatment models using cognitive behavioral therapy for insomnia (CBT-I) and positive airway pressure (PAP) for people with obstructive sleep apnea (OSA) and comorbid insomnia. METHODS 121 adults with OSA and comorbid insomnia were randomized to receive CBT-I followed by PAP, CBT-I concurrent with PAP, or PAP only. PAP was delivered following standard clinical procedures for in-lab titration and home setup and CBT-I was delivered in four individual sessions. The primary outcome measure was PAP adherence across the first 90 days, with regular PAP use (≥4 h on ≥70% of nights during a 30-day period) serving as the clinical endpoint. The secondary outcome measures were the Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI) with good sleeper (PSQI <5), remission (ISI <8), and response (ISI reduction from baseline >7) serving as the clinical endpoints. RESULTS No significant differences were found between the concomitant treatment arms and PAP only on PAP adherence measures, including the percentage of participants who met the clinical endpoint. Compared to PAP alone, the concomitant treatment arms reported a significantly greater reduction from baseline on the ISI (p = .0009) and had a greater percentage of participants who were good sleepers (p = .044) and remitters (p = .008). No significant differences were found between the sequential and concurrent treatment models on any outcome measure. CONCLUSIONS The findings from this study indicate that combining CBT-I with PAP is superior to PAP alone on insomnia outcomes but does not significantly improve adherence to PAP.",2020,"No significant differences were found between the concomitant treatment arms versus PAP only on PAP adherence measures, including the percentage of participants who met the clinical endpoint.","['people with obstructive sleep apnea (OSA) and comorbid insomnia', '121 adults with OSA and comorbid insomnia', 'Obstructive Sleep Apnea and Comorbid Insomnia']","['cognitive-behavior therapy for insomnia (CBT-I) and positive airway pressure (PAP', 'CBT-I followed by PAP, CBT-I concurrent with PAP, or PAP only', 'CBT-I and PAP']","['PAP adherence measures', 'PAP adherence across the first 90 days, with regular PAP use', 'adherence to PAP', 'Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI) with good sleeper (PSQI< 5), remission (ISI< 8), and response (ISI reduction from baseline > 7) serving as the clinical endpoints']","[{'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",121.0,0.0274862,"No significant differences were found between the concomitant treatment arms versus PAP only on PAP adherence measures, including the percentage of participants who met the clinical endpoint.","[{'ForeName': 'Jason C', 'Initials': 'JC', 'LastName': 'Ong', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Megan R', 'Initials': 'MR', 'LastName': 'Crawford', 'Affiliation': 'School of Psychological Sciences and Health, University of Strathclyde, Glasgow, UK.'}, {'ForeName': 'Spencer C', 'Initials': 'SC', 'LastName': 'Dawson', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Louis F', 'Initials': 'LF', 'LastName': 'Fogg', 'Affiliation': 'College of Nursing, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Arlener D', 'Initials': 'AD', 'LastName': 'Turner', 'Affiliation': 'Center for Sleep and Brain Health, Department of Psychiatry, New York University, New York, NY.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Wyatt', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Maria I', 'Initials': 'MI', 'LastName': 'Crisostomo', 'Affiliation': 'Department of Medicine, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Bantu S', 'Initials': 'BS', 'LastName': 'Chhangani', 'Affiliation': 'Department of Medicine, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Clete A', 'Initials': 'CA', 'LastName': 'Kushida', 'Affiliation': 'Division of Sleep Medicine, Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA.'}, {'ForeName': 'Jack D', 'Initials': 'JD', 'LastName': 'Edinger', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, National Jewish Health, Denver, CO.'}, {'ForeName': 'Sabra M', 'Initials': 'SM', 'LastName': 'Abbott', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Roneil G', 'Initials': 'RG', 'LastName': 'Malkani', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Hrayr P', 'Initials': 'HP', 'LastName': 'Attarian', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Phyllis C', 'Initials': 'PC', 'LastName': 'Zee', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, IL.'}]",Sleep,['10.1093/sleep/zsaa041'] 246,32170355,"Topical co-delivery of platelet rich fibrin and tranexamic acid does not decrease blood loss in primary total knee arthroplasty compared to the standard of care: a prospective, randomized, controlled trial.","PURPOSE The purpose of this study was to evaluate the efficacy of intra-operative co-administration of tranexamic acid (TA) and platelet rich fibrin (PRF) using a proprietary co-delivery system on the amount of blood loss, early functional outcomes and wound complications after primary total knee arthroplasty (TKA). The intervention was compared to the standard of care (combined intravenous & topical TA) in a prospective, randomized, blinded setting. METHODS 80 patients undergoing primary cemented TKA without tourniquet were prospectively randomized into control (combined intravenous and topical TA) and PRF (intra-venous TA and co-delivery of topical PRF and TA) groups after informed consent. Total blood loss, drainage blood loss, knee range of motion, VAS pain scores, length of stay and wound complications were analysed. Data collection was performed in a double blind manner on days 1, 3 and 21. RESULTS There was no statistically significant difference in drainage blood loss (550 ml vs. 525 ml, p = 0.643), calculated total blood loss on day 1 (401 ml vs. 407 ml, p = 0.722), day 3 (467 ml vs 471 ml, p = 0.471) and day 21 (265 ml vs. 219 ml, p = 0.082) between the PRF and control groups respectively. The PRF group had a small but statistically significant increase in median knee extension in the early post-operative period, however this difference evened out at 3 weeks. No significant difference could be demonstrated between the PRF and control groups in length of stay, VAS pain scores, narcotic usage, wound complications and knee flexion at all time points. CONCLUSIONS The topical co-delivery of PRF and TA does not significantly decrease blood loss in primary TKA compared to the standard of care. Slightly better active knee extension in the first 3 postoperative days can be achieved, however this benefit is not clinically relevant. LEVEL OF EVIDENCE I, Therapeutic study.",2021,"No significant difference could be demonstrated between the PRF and control groups in length of stay, VAS pain scores, narcotic usage, wound complications and knee flexion at all time points. ","['80 patients undergoing primary cemented TKA without tourniquet', 'primary total knee arthroplasty (TKA', 'primary total knee arthroplasty']","['control (combined intravenous and topical TA) and PRF (intra-venous TA and co-delivery of topical PRF and TA', 'Topical co-delivery of platelet rich fibrin and tranexamic acid', 'tranexamic acid (TA) and platelet rich fibrin (PRF', 'standard of care (combined intravenous & topical TA']","['drainage blood loss', 'blood loss, early functional outcomes and wound complications', 'Total blood loss, drainage blood loss, knee range of motion, VAS pain scores, length of stay and wound complications', 'length of stay, VAS pain scores, narcotic usage, wound complications and knee flexion at all time points', 'median knee extension', 'blood loss', 'calculated total blood loss']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1704479', 'cui_str': 'Cement'}, {'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0033374', 'cui_str': 'Prolactin-Releasing Peptide'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C4505052', 'cui_str': 'L-PRF'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}]","[{'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1096106'}, {'cui': 'C0232100', 'cui_str': 'Exsanguinating Hemorrhage'}, {'cui': 'C0576094', 'cui_str': 'Knee range of motion'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}]",80.0,0.114778,"No significant difference could be demonstrated between the PRF and control groups in length of stay, VAS pain scores, narcotic usage, wound complications and knee flexion at all time points. ","[{'ForeName': 'Reha N', 'Initials': 'RN', 'LastName': 'Tandogan', 'Affiliation': 'Ortoklinik and Cankaya Orthopedics, Cinnah caddesi 51/4, Cankaya, 06680, Ankara, Turkey. rtandogan@gmail.com.'}, {'ForeName': 'Metin', 'Initials': 'M', 'LastName': 'Polat', 'Affiliation': 'Ortoklinik and Cankaya Orthopedics, Cinnah caddesi 51/4, Cankaya, 06680, Ankara, Turkey.'}, {'ForeName': 'Tahsin', 'Initials': 'T', 'LastName': 'Beyzadeoglu', 'Affiliation': 'Orthopaedics and Traumatology, Halic University and Beyzadeoglu Clinic, Bagdat Cad. No: 333 Erenkoy, 34738, Istanbul, Turkey.'}, {'ForeName': 'Erdem', 'Initials': 'E', 'LastName': 'Karabulut', 'Affiliation': 'Department of Biostatistics, Hacettepe University, Sihhiye Campus, Ankara, Turkey.'}, {'ForeName': 'Kerem', 'Initials': 'K', 'LastName': 'Yildirim', 'Affiliation': 'Orthopaedics and Traumatology, Istanbul Gelisim University and Beyzadeoglu Clinic, Bagdat Cad. No: 333 Erenkoy, 34738, Istanbul, Turkey.'}, {'ForeName': 'Asim', 'Initials': 'A', 'LastName': 'Kayaalp', 'Affiliation': 'Ortoklinik and Cankaya Orthopedics, Cinnah caddesi 51/4, Cankaya, 06680, Ankara, Turkey.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-020-05938-1'] 247,32172362,Changes in Bariatric Patients' Physical Activity Levels and Health-Related Quality of Life Following a Postoperative Motivational Physical Activity Intervention.,"PURPOSE Self-determination theory (SDT) has been widely used as a useful motivational framework for improving long-term adherence to physical activity (PA) and health-related quality of life (HRQoL). The aim of this study was to examine the effects of a 6-month motivational PA intervention (MPAI) on bariatric patients' PA levels and HRQoL from pre-surgery to the end of the MPAI (7 months post-surgery). Additionally, a re-test was performed 13 months post-surgery. METHODS A total of 40 participants undergoing sleeve gastrectomy were assigned to a 6-month MPAI or to a control group. The MPAI was based on techniques and messages from SDT. At baseline and post-intervention measures, both groups wore accelerometers for one week and completed the SF-36 questionnaire. RESULTS A total of 32 participants (78.1% female) completed all measures and were included in the final analyses. PA levels did not significantly differ between groups as a consequence of the intervention. Clinically significant differences (d ≥ 0.5) favoring the MPAI group were found for SF-36 domains of bodily pain (at pre-surgery, increasing at 7 and 13 months post-surgery), general health and vitality (7 months post-surgery), and physical functioning and physical component score (both 7 and 13 months post-surgery). Social functioning also showed clinically significant differences favoring the MPAI group at pre-surgery, increasing at 7 months post-surgery. These differences disappeared at 13 months post-surgery. CONCLUSIONS SDT-based PA interventions could enhance several dimensions of bariatric patients' HRQoL after surgery. Further research is needed to understand what motivational processes are key aspects to promote PA participation in these patients.",2020,"Clinically significant differences (d ≥ 0.5) favoring the MPAI group were found for SF-36 domains of bodily pain (at pre-surgery, increasing at 7 and 13 months post-surgery), general health and vitality (7 months post-surgery), and physical functioning and physical component score (both 7 and 13 months post-surgery).","['A total of 32 participants (78.1% female) completed all measures and were included in the final analyses', '40 participants undergoing sleeve gastrectomy']","['SDT-based PA interventions', 'Self-determination theory (SDT', 'motivational PA intervention (MPAI']","['Social functioning', 'physical functioning and physical component score', 'SF-36 questionnaire', 'general health and vitality', ""Bariatric Patients' Physical Activity Levels and Health-Related Quality of Life"", 'PA levels', 'SF-36 domains of bodily pain']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036595', 'cui_str': 'Self Determination'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",40.0,0.0220962,"Clinically significant differences (d ≥ 0.5) favoring the MPAI group were found for SF-36 domains of bodily pain (at pre-surgery, increasing at 7 and 13 months post-surgery), general health and vitality (7 months post-surgery), and physical functioning and physical component score (both 7 and 13 months post-surgery).","[{'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Jiménez-Loaisa', 'Affiliation': 'Department of Sport Sciences, Sport Research Centre, Miguel Hernández University of Elche, Avenida de la Universidad s/n, 03202, Elche, Alicante, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'González-Cutre', 'Affiliation': 'Department of Sport Sciences, Sport Research Centre, Miguel Hernández University of Elche, Avenida de la Universidad s/n, 03202, Elche, Alicante, Spain. dgonzalez-cutre@umh.es.'}, {'ForeName': 'Vicente J', 'Initials': 'VJ', 'LastName': 'Beltrán-Carrillo', 'Affiliation': 'Department of Sport Sciences, Sport Research Centre, Miguel Hernández University of Elche, Avenida de la Universidad s/n, 03202, Elche, Alicante, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Alcaraz-Ibáñez', 'Affiliation': 'Department of Education, Faculty of Education Sciences, University of Almería, Carretera Sacramento s/n, 04120, La Cañada de San Urbano, Almería, Spain.'}]",Obesity surgery,['10.1007/s11695-020-04489-1'] 248,32171815,Efficacy of targeted education in reducing topical steroid phobia: A randomized clinical trial.,"BACKGROUND Fear of adverse effects of corticosteroids is common in dermatology and results in medication nonadherence. OBJECTIVE To study the efficacy of targeted education in reducing topical steroid phobia. METHODS In this double-blinded, randomized controlled trial, participants in the intervention arm were presented with an educational video and patient information leaflet targeting common misconceptions of topical corticosteroids. Steroid phobia was assessed with the topical corticosteroid phobia (TOPICOP) scale, medication adherence with the Elaboration d'un outil d'evaluation de l'observance des traitements medicamenteux (ECOB) score, and quality of life with the Dermatology Life Quality Index (DLQI). RESULTS The study randomized 275 patients. The mean TOPICOP score in the intervention arm decreased (improved) from 41.9 (SD, 17.4) to 37.1 (SD, 20.0) and to 33.8 (SD, 19.0) at 1 month and 3 months, respectively, with the reduction arising from the knowledge domain but not the fears and behaviors domain. This remained statistically significant after adjusting for demographic confounding with an expected reduction of 4.22 points (P = .031). After accounting for demographic factors, there was no statistical difference in medication adherence and quality of life. Limitations include the exclusion of non-English-speaking patients. CONCLUSION Targeted education at a single time point improved the TOPICOP score primarily in the knowledge domain but not in the fear domain.",2020,"© score in the intervention arm decreased (improved) from 41.9 (SD,17.4) to 37.1 (SD,20.0) and 33.8 (SD,19.0) at 1 month and 3 months, respectively with the reduction arising from the knowledge domain but not the fears and behaviours domain.",['275 patients were randomised'],"['TOPICOP', 'educational video and patient information leaflet targeting common misconceptions of topical corticosteroids', 'corticosteroids', 'Targeted Education']","['Mean (SD) TOPICOP', 'medication adherence and quality of life', '© scale, medication adherence with the ECOB score, and quality of life with the DLQI', 'Steroid phobia']","[{'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0034380'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0349231', 'cui_str': 'Phobias'}]",275.0,0.151103,"© score in the intervention arm decreased (improved) from 41.9 (SD,17.4) to 37.1 (SD,20.0) and 33.8 (SD,19.0) at 1 month and 3 months, respectively with the reduction arising from the knowledge domain but not the fears and behaviours domain.","[{'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Choi', 'Affiliation': 'Division of Dermatology, Department of Medicine, National University Health System, Singapore. Electronic address: ellie_choi@nuhs.edu.sg.'}, {'ForeName': 'Ken Wei', 'Initials': 'KW', 'LastName': 'Tan', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore.'}, {'ForeName': 'Fengjie', 'Initials': 'F', 'LastName': 'Tang', 'Affiliation': 'Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Tan', 'Affiliation': 'Division of Dermatology, Department of Medicine, National University Health System, Singapore.'}, {'ForeName': 'Nisha Suyien', 'Initials': 'NS', 'LastName': 'Chandran', 'Affiliation': 'Division of Dermatology, Department of Medicine, National University Health System, Singapore.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.02.079'] 249,32166421,The effect of heart rate variability on blood pressure is augmented in spinal cord injury and is unaltered by exercise training.,"PURPOSE To define differences in heart rate and blood pressure variability (HRV/BPV) after spinal cord injury (SCI) compared with uninjured controls, and to determine whether variabilities are impacted by whole-body exercise after SCI. METHODS Individuals with SCI (n = 40), aged 18-40, and uninjured age/sex-matched controls (n = 22) had HRV and BPV determined during supine paced (0.25 Hz) breathing. Spectral and cross-spectral values were derived for fluctuations at low (LF 0.05-0.15 Hz) and high (HF 0.20-0.30 Hz) frequencies. Thirty-two individuals with SCI further underwent either 6 months of whole-body exercise training (n = 17) or a control intervention (n = 15). RESULTS Individuals with SCI had injuries graded A-C in severity, neurological levels of injury C1-T10. LF and HF HRV and LF BPV were significantly lower in individuals with SCI (p = 0.008-0.002), though HF BPV was similar. The LF cross-spectrum demonstrated similar phase and gain relationships between groups. The HF phase relationship between pressure and heart rate differed markedly: individuals with SCI demonstrated a -11.7 ± 3.4° phase lag (241 ± 70 ms feedback mechanism of pressure into heart rate), whereas uninjured controls demonstrated a +21.5 ± 10.8° phase lead (443 ± 224 ms feedforward mechanism of heart rate into pressure, p = 0.007). Whole-body exercise increased mean VO 2peak by 2.09 ml/kg, whereas HRV, BPV, and their cross-spectral relationships were not significantly altered relative to the control intervention after SCI. CONCLUSION After SCI, marked frequency-specific differences exist in the relationship between heart rate and blood pressure variabilities. The high-frequency cross-spectral relationship indicates that a feedback mechanism of blood pressure into heart rate may predominate in this range.",2021,"LF and HF HRV and LF BPV were significantly lower in individuals with SCI (p = 0.008-0.002), though HF BPV was similar.","['Thirty-two individuals with SCI further underwent either', 'Individuals with SCI (n\u2009=\u200940), aged 18-40, and uninjured age/sex-matched controls (n\u2009=\u200922) had HRV and BPV determined during supine paced (0.25\xa0Hz) breathing']","['control intervention', '6\xa0months of whole-body exercise training']","['pressure and heart rate', 'LF and HF HRV and LF BPV', 'heart rate and blood pressure variabilities', 'injuries graded A-C in severity, neurological levels of injury C1-T10', 'HF BPV', 'blood pressure', 'HRV, BPV, and their cross-spectral relationships', 'heart rate and blood pressure variability (HRV/BPV', 'mean VO 2peak']","[{'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0531207', 'cui_str': 'bpV(phen)'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0531207', 'cui_str': 'bpV(phen)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0309195', 'cui_str': 'Grade A (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0442771,"LF and HF HRV and LF BPV were significantly lower in individuals with SCI (p = 0.008-0.002), though HF BPV was similar.","[{'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Solinsky', 'Affiliation': 'Cardiovascular Research Laboratory, Spaulding Rehabilitation Hospital, Cambridge, MA, USA. rsolinsky@mgh.harvard.edu.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Vivodtzev', 'Affiliation': 'Cardiovascular Research Laboratory, Spaulding Rehabilitation Hospital, Cambridge, MA, USA.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Hamner', 'Affiliation': 'Cardiovascular Research Laboratory, Spaulding Rehabilitation Hospital, Cambridge, MA, USA.'}, {'ForeName': 'J Andrew', 'Initials': 'JA', 'LastName': 'Taylor', 'Affiliation': 'Cardiovascular Research Laboratory, Spaulding Rehabilitation Hospital, Cambridge, MA, USA.'}]",Clinical autonomic research : official journal of the Clinical Autonomic Research Society,['10.1007/s10286-020-00677-2'] 250,32166624,Effects of Low-Dose Amitriptyline on Epigastric Pain Syndrome in Functional Dyspepsia Patients.,"AIM To observe the therapeutic effect of low-dose amitriptyline (AMT) on epigastric pain syndrome (EPS) in patients with functional dyspepsia. METHODS Sixty patients with EPS were randomly divided into the following two groups for a four-week clinical trial: routine treatment with pantoprazole (RT group) and the AMT group. The RT group was treated with 40 mg of pantoprazole once daily. The AMT group received 25 mg of AMT once daily before bedtime. The Nepean Dyspepsia Index (NDI) checklist, Hamilton Rating Scale of Anxiety/Depression (HAMA/HAMD), and Pittsburgh Sleep Quality Index (PSQI) were employed to evaluate dyspepsia symptoms, psychological distress, and sleep, respectively. RESULTS All items were similar between the two groups before treatment (0 week). After 4 weeks of treatment, the NDI-symptom checklist score as well as the severity and bothersomeness of EPS in the AMT group was significantly decreased compared with those in the RT group (p < 0.05). However, no differences were found in the frequency of NDI checklist, psychological status (HAMD/HAMA scores) of EPS, or sleep quality (PSQI score) between the two groups after treatment. In addition, the time to fall asleep was shorter in the AMT group compared with the RT group after 4 weeks of treatment (p < 0.05). CONCLUSION Low-dose AMT effectively improved the dyspepsia symptoms and the time to fall asleep in the EPS patients, compared with pantoprazole, although it did not reduce the psychological distress. Therefore, AMT could be considered as a good candidate for EPS treatment in the clinic.",2021,"Low-dose AMT effectively improved the dyspepsia symptoms and the time to fall asleep in the EPS patients, compared with pantoprazole, although it did not reduce the psychological distress.","['Sixty patients with EPS', 'patients with functional dyspepsia', 'Functional Dyspepsia Patients']","['pantoprazole', 'AMT', 'pantoprazole (RT group) and the AMT', 'low-dose amitriptyline (AMT', 'Low-Dose Amitriptyline']","['Nepean Dyspepsia Index (NDI) checklist, Hamilton Rating Scale of Anxiety', 'epigastric pain syndrome (EPS', 'Epigastric Pain Syndrome', 'dyspepsia symptoms, psychological distress, and sleep, respectively', 'NDI-symptom checklist score', 'time to fall asleep', 'Depression (HAMA/HAMD), and Pittsburgh Sleep Quality Index (PSQI', 'frequency of NDI checklist, psychological status (HAMD/HAMA scores) of EPS, or sleep quality (PSQI score', 'severity and bothersomeness of EPS', 'dyspepsia symptoms and the time to fall asleep', 'psychological distress']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia (disorder)'}]","[{'cui': 'C0081876', 'cui_str': 'pantoprazole'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0002600', 'cui_str': 'Amitriptyline'}]","[{'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0222045'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0232493', 'cui_str': 'Epigastric pain (finding)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",60.0,0.0200608,"Low-dose AMT effectively improved the dyspepsia symptoms and the time to fall asleep in the EPS patients, compared with pantoprazole, although it did not reduce the psychological distress.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Gastroenterology, Guangzhou First People's Hospital, the Second Affiliated Hospital of South China University of Technology, No. 1 Panfu Road, Guangzhou, 510180, Guangdong, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Jia', 'Affiliation': ""Department of Gastroenterology, Guangzhou First People's Hospital, the Second Affiliated Hospital of South China University of Technology, No. 1 Panfu Road, Guangzhou, 510180, Guangdong, China. 13925012853@139.com.""}, {'ForeName': 'Shu-Man', 'Initials': 'SM', 'LastName': 'Jiang', 'Affiliation': ""Department of Gastroenterology, Guangzhou First People's Hospital, the Second Affiliated Hospital of South China University of Technology, No. 1 Panfu Road, Guangzhou, 510180, Guangdong, China.""}, {'ForeName': 'Wen-Cong', 'Initials': 'WC', 'LastName': 'Zhou', 'Affiliation': ""Department of Gastroenterology, Guangzhou First People's Hospital, the Second Affiliated Hospital of South China University of Technology, No. 1 Panfu Road, Guangzhou, 510180, Guangdong, China.""}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Gastroenterology, Guangzhou First People's Hospital, the Second Affiliated Hospital of South China University of Technology, No. 1 Panfu Road, Guangzhou, 510180, Guangdong, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Department of Psychology, Guangzhou Nansha Central Hospital Affiliated to Guangzhou First People's Hospital, No. 105 Fengze Road East, Guangzhou, 511457, Guangdong, China.""}]",Digestive diseases and sciences,['10.1007/s10620-020-06191-9'] 251,32161005,Risk factors for subretinal fibrosis after anti-VEGF treatment of myopic choroidal neovascularisation.,"PURPOSE To assess the incidence, clinical features and predictive risk factors of subretinal fibrosis after treatment of active myopic choroidal neovascularisation (mCNV) with anti-vascular endothelial growth factor (VEGF). METHODS This post-hoc analysis of a randomised controlled trial included a total of 54 patients with active mCNV. The clinical data at baseline, month 3 and month 12 were used. Fundus photography and optical coherence tomography at month 3 were used to determine the presence of subretinal fibrosis after anti-VEGF therapy, and its incidence was calculated. Best-corrected visual acuity (BCVA), Visual Function Questionnaire-25 score, macular integrity index (MI) and their changes were compared between eyes with and without subretinal fibrosis. A logistic regression model was used to evaluate the risk factors of subretinal fibrosis. RESULTS Subretinal fibrosis occurred in 22 of 54 eyes with mCNV. Patients with subretinal fibrosis achieved similar BCVA improvement in comparison with those without fibrosis at 3 and 12 months after the treatment; however, they had lower visual acuity, more subfoveal CNV (p=0.002), higher CNV thickness at baseline (p=0.016), larger CNV size (p=0.030), larger leakage area (p=0.021) and higher presence of advanced myopic maculopathy (p=0.035). Age <45 years, BCVA <60 ETDRS letters, and MI index <20 at baseline were the predictors for subretinal fibrosis occurrence in a logistic regression model. CONCLUSIONS The incidence of subretinal fibrosis after anti-VEGF therapy was 40.7% in eyes with mCNV. Age, baseline BCVA and MI index could serve as predictive risk factors of subretinal fibrosis after anti-VEGF treatment in patients with mCNV.",2021,"Patients with subretinal fibrosis achieved similar BCVA improvement in comparison with those without fibrosis at 3 and 12 months after the treatment; however, they had lower visual acuity, more subfoveal CNV (p=0.002), higher CNV thickness at baseline (p=0.016), larger CNV size (p=0.030), larger leakage area (p=0.021) and higher presence of advanced myopic maculopathy (p=0.035).","['myopic choroidal neovascularisation', 'Age', '54 patients with active mCNV']",['active myopic choroidal neovascularisation (mCNV) with anti-vascular endothelial growth factor (VEGF'],"['larger leakage area', 'Subretinal fibrosis', 'advanced myopic maculopathy', 'BCVA improvement', 'subfoveal CNV', 'incidence of subretinal fibrosis', 'larger CNV size', 'higher CNV thickness', 'Best-corrected visual acuity (BCVA), Visual Function Questionnaire-25 score, macular integrity index (MI', 'visual acuity']","[{'cui': 'C3665926', 'cui_str': 'Myopic choroidal neovascularization'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C3665926', 'cui_str': 'Myopic choroidal neovascularization'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0423434', 'cui_str': 'Subretinal fibrosis (finding)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0730362', 'cui_str': 'Maculopathy'}, {'cui': 'C0442185', 'cui_str': 'Subfoveal (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}]",54.0,0.0951671,"Patients with subretinal fibrosis achieved similar BCVA improvement in comparison with those without fibrosis at 3 and 12 months after the treatment; however, they had lower visual acuity, more subfoveal CNV (p=0.002), higher CNV thickness at baseline (p=0.016), larger CNV size (p=0.030), larger leakage area (p=0.021) and higher presence of advanced myopic maculopathy (p=0.035).","[{'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Xiao', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou 510060, China.'}, {'ForeName': 'Xiujuan', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou 510060, China.'}, {'ForeName': 'Songshan', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou 510060, China.'}, {'ForeName': 'Limei', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou 510060, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Xin', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou 510060, China.'}, {'ForeName': 'Zhirong', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou 510060, China.'}, {'ForeName': 'Aiyuan', 'Initials': 'A', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou 510060, China.'}, {'ForeName': 'Junyan', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Statistics, Bothwin Clinical Study US, Redmond, Washington, USA.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Ding', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou 510060, China dingxy75@gmail.com.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2019-315763'] 252,30980223,A web-based physical activity intervention benefits persons with low self-efficacy in COPD: results from a randomized controlled trial.,"Promoting physical activity (PA) is of top priority in chronic obstructive pulmonary disease (COPD). This study examines the influence of an internet-delivered intervention on the relationship between exercise self-efficacy and changes in PA, physical health, and exercise capacity in COPD. 112 U.S. Veterans with COPD were randomized to either a comparison (pedometer alone) or an intervention group (pedometer plus access to an internet-mediated PA intervention). There was a significant interaction between baseline exercise self-efficacy and randomization group on change in PA. In the comparison group, there was a significant relationship between higher baseline exercise self-efficacy and greater change in PA, whereas in the intervention group, improvements in PA were independent of level of baseline self-efficacy. Similar patterns were found with physical health and exercise capacity as outcomes. The use of an internet-mediated intervention significantly benefited persons with COPD who had low baseline self-efficacy to increase PA and physical health.Clinical trial registration The randomized clinical trial was registered on ClinicalTrials.gov (NCT01772082).",2019,The use of an internet-mediated intervention significantly benefited persons with COPD who had low baseline self-efficacy to increase PA and physical health.,"['chronic obstructive pulmonary disease (COPD', 'persons with COPD who had low baseline self-efficacy to increase PA and physical health', 'benefits persons with low self-efficacy in COPD', '112 U.S. Veterans with COPD']","['A web-based physical activity intervention', 'internet-mediated intervention', 'internet-delivered intervention', 'comparison (pedometer alone) or an intervention group (pedometer plus access to an internet-mediated PA intervention']",['higher baseline exercise self-efficacy and greater change in PA'],"[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.0817305,The use of an internet-mediated intervention significantly benefited persons with COPD who had low baseline self-efficacy to increase PA and physical health.,"[{'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Robinson', 'Affiliation': 'Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA, USA. stephanie.robinson5@va.gov.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Shimada', 'Affiliation': 'Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA, USA.'}, {'ForeName': 'Karen S', 'Initials': 'KS', 'LastName': 'Quigley', 'Affiliation': 'Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA, USA.'}, {'ForeName': 'Marilyn L', 'Initials': 'ML', 'LastName': 'Moy', 'Affiliation': 'VA Boston Healthcare System, Boston, MA, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-019-00042-3'] 253,32086358,Tackling frailty at primary care: evaluation of the effectiveness of a multicomponent intervention through a randomised controlled trial: study protocol.,"INTRODUCTION This project focuses on how frailty is addressed in primary healthcare (PHC) and will evaluate the effectiveness of a multifactorial intervention (considering the appropriateness of the pharmaceutical prescription, the nutritional care provided and the exercise intervention) for persons with frailty, in terms of improving their functional capacity and reducing the incidence of adverse events related to frailty. The final evaluation will be made at 12 months' follow-up. METHODS AND ANALYSIS Pragmatic multicentre cluster randomised controlled clinical trial, single blind with two arms: multifactorial intervention in PHC versus usual follow-up. The randomisation unit is the patient list and the analysis unit is the patient. In addition, a cost-effectiveness study and a qualitative study will be carried out, the latter based on semistructured interviews and focus groups. Two hundred persons (100 per study branch) all aged ≥70 years, presenting frailty, but functionally independent and resident in the community, will be recruited. A baseline evaluation will be carried out prior to the intervention, with follow-up at 6 and 12 months. The main study variables considered will be functional capacity and incidence of adverse events; the secondary variables considered will be the patients' sociodemographic characteristics, nutritional status, level of physical activity and drug consumption, together with data on comorbidity, cognitive and affective status and health-related quality of life. Data will be analysed according to the intention-to-treat principle using a 5% significance level. ETHICS AND DISSEMINATION The study will at all times be conducted in strict accordance with the provisions of the Declaration of Helsinki and with the national legislation regulating patients' autonomy. All patients recruited will be asked to provide written informed consent before taking part in the clinical trial. On completion of the study, the principal investigator expects to publish the results of this research in a peer-reviewed open access scientific journal. TRIAL REGISTRATION NUMBER ISRCTN17143761.",2020,"This project focuses on how frailty is addressed in primary healthcare (PHC) and will evaluate the effectiveness of a multifactorial intervention (considering the appropriateness of the pharmaceutical prescription, the nutritional care provided and the exercise intervention) for persons with frailty, in terms of improving their functional capacity and reducing the incidence of adverse events related to frailty.","['primary healthcare (PHC', 'persons with frailty', 'Two hundred persons (100 per study branch) all aged ≥70 years, presenting frailty, but functionally independent and resident in the community, will be recruited']","['multifactorial intervention in PHC versus usual follow-up', 'multifactorial intervention', 'multicomponent intervention']","['functional capacity and incidence of adverse events', 'sociodemographic characteristics, nutritional status, level of physical activity and drug consumption, together with data on comorbidity, cognitive and affective status and health-related quality of life']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205384', 'cui_str': 'Branching (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C4273559', 'cui_str': 'Functionally independent'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",,0.071683,"This project focuses on how frailty is addressed in primary healthcare (PHC) and will evaluate the effectiveness of a multifactorial intervention (considering the appropriateness of the pharmaceutical prescription, the nutritional care provided and the exercise intervention) for persons with frailty, in terms of improving their functional capacity and reducing the incidence of adverse events related to frailty.","[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Rivas-Ruiz', 'Affiliation': 'Unidad de Investigación, Agencia Sanitaria Costa del Sol, Marbella, Málaga, Spain.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Machón', 'Affiliation': 'Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Madrid, Spain monica.machonsobrado@osakidetza.eus.'}, {'ForeName': 'Maider', 'Initials': 'M', 'LastName': 'Mateo-Abad', 'Affiliation': 'Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Madrid, Spain.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Contreras-Fernández', 'Affiliation': 'Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Madrid, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Güell', 'Affiliation': 'Instituto de Investigación Sanitaria Biodonostia, Grupo de Atención Primaria, San Sebastián, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Baro-Rodríguez', 'Affiliation': 'Área del Medicamento, Distrito Sanitario de Atencion Primaria Costa del Sol, Mijas, Spain.'}, {'ForeName': 'Kalliopi', 'Initials': 'K', 'LastName': 'Vrotsou', 'Affiliation': 'Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Madrid, Spain.'}, {'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'Quirós-López', 'Affiliation': 'Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Madrid, Spain.'}, {'ForeName': 'Itziar', 'Initials': 'I', 'LastName': 'Vergara', 'Affiliation': 'Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-034591'] 254,32086359,"Improving reproductive function in women with polycystic ovary syndrome with high-intensity interval training (IMPROV-IT): study protocol for a two-centre, three-armed randomised controlled trial.","INTRODUCTION Polycystic ovary syndrome (PCOS) is a common endocrine disorder in women of reproductive age and the leading cause of anovulatory infertility. Women with PCOS have a 15-fold higher prevalence of infertility, compared with women without PCOS, independent of body mass index (BMI). A healthy lifestyle is recommended to improve overall health and fertility in PCOS but there is limited evidence on the isolated effects of exercise, especially for reproductive outcomes. Previous findings indicate superior metabolic health benefits after vigorous compared with moderate-intensity exercise. Our primary aim is to determine the effect of high-intensity interval training (HIT) on menstrual frequency, as a proxy of reproductive function, in women with PCOS. METHODS AND ANALYSIS The study is a two-centre, randomised, controlled trial with three parallel groups. Women (n=64) from Trondheim (Norway) and Melbourne (Australia) with PCOS according to the Rotterdam criteria will be randomly allocated (1:1:1) to high-volume HIT, low-volume HIT or a control group with no exercise after stratifying for BMI < or ≥ 27 kg/m 2 and study centre. Measurements for study end points will be undertaken at baseline, after a 16 week exercise intervention and at 12 months following baseline assessments. The primary outcome measure is menstruation frequency, measured as the number of self-reported menstrual bleedings divided by the number of expected menstrual bleedings during a 12-month period. Secondary outcome measurements include markers of cardiovascular, metabolic and reproductive health, as well as quality of life and adherence to and enjoyment of exercise. ETHICS AND DISSEMINATION The Regional Committee Medical Research Ethics, Norway, and The Australian Catholic University Human Research Ethics Committee, Australia, have approved the trial protocol. This trial will provide new insight regarding the impact of exercise on fertility in PCOS. We expect this trial to contribute to new therapeutic exercise strategies as part of clinical care for women with PCOS. TRIAL REGISTRATION NUMBER Clinical trial gov NCT02419482.",2020,"Women with PCOS have a 15-fold higher prevalence of infertility, compared with women without PCOS, independent of body mass index (BMI).","['Women (n=64) from Trondheim (Norway) and Melbourne (Australia) with PCOS according to the Rotterdam criteria', 'women with PCOS', 'women with polycystic ovary syndrome with high-intensity interval training (IMPROV-IT']","['high-intensity interval training (HIT', 'high-volume HIT, low-volume HIT or a control group with no exercise after stratifying for BMI < or ≥ 27\u2009kg/m 2 and study centre']","['overall health and fertility in PCOS', 'menstruation frequency, measured as the number of self-reported menstrual bleedings divided by the number of expected menstrual bleedings', 'markers of cardiovascular, metabolic and reproductive health, as well as quality of life and adherence to and enjoyment of exercise']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0960740', 'cui_str': 'ImProv'}]","[{'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0596020', 'cui_str': 'Does hit (finding)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0034380'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.352155,"Women with PCOS have a 15-fold higher prevalence of infertility, compared with women without PCOS, independent of body mass index (BMI).","[{'ForeName': 'Ida Almenning', 'Initials': 'IA', 'LastName': 'Kiel', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Lionett', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Evelyn Bridget', 'Initials': 'EB', 'LastName': 'Parr', 'Affiliation': 'Exercise and Nutrition Research Programme, Mary Mackillop Institute for Health Research, Australian Catholic University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Jones', 'Affiliation': 'Research Institute for Sport and Exercise Science (RISES), Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Maria Aurora Hernandez', 'Initials': 'MAH', 'LastName': 'Røset', 'Affiliation': 'Department of Obstetrics and Gynaecology, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Øyvind', 'Initials': 'Ø', 'LastName': 'Salvesen', 'Affiliation': 'Unit of Applied Clinical Research, Department of Public Health and Nursing, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Eszter', 'Initials': 'E', 'LastName': 'Vanky', 'Affiliation': 'Department of Obstetrics and Gynaecology, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Trine', 'Initials': 'T', 'LastName': 'Moholdt', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway trine.moholdt@ntnu.no.'}]",BMJ open,['10.1136/bmjopen-2019-034733'] 255,32075842,High-flow nasal oxygenation versus standard oxygenation for gastrointestinal endoscopy with sedation. The prospective multicentre randomised controlled ODEPHI study protocol.,"INTRODUCTION Hypoxaemia is a major complication during gastrointestinal endoscopy (GIE) procedures (upper/lower) when performed under deep sedation in the procedure room. Standard oxygen therapy (SOT) is used to prevent hypoxaemia. Data suggest that risk factors for hypoxaemia under deep sedation during GIE are obstructive sleep apnoea syndrome, a body mass index above 30 kg/m², high blood pressure, diabetes, heart disease, age over 60 years old, high American Society of Anesthesiologists physical status class and the association of upper and lower GIE. High-flow nasal oxygenation (HFNO) may potentially improve oxygenation during GIE under deep sedation. We hypothesised that HFNO could decrease the incidence of hypoxaemia in comparison with SOT. METHODS AND ANALYSIS The ODEPHI (High-flow nasal o xygenation versus standar d oxygenation for gastrointestinal e ndosco p y wit h sedation. The prospect i ve multicentre randomised controlled) study is a multicentre randomised controlled trial comparing HFNO to SOT during GIE (upper and/or lower) under deep sedation administered by anaesthesiologists in the procedure room. Three hundred and eighty patients will be randomised with a 1:1 ratio in two parallel groups.The primary outcome is the occurrence of hypoxaemia, defined by a pulse oximetry measurement of peripheral capillary oxygen saturation (SpO 2 ) below or equal to 92% during the GIE procedure. Secondary outcomes include prolonged hypoxaemia, severe hypoxaemia, need for manoeuvres to maintain upper airway patency and other adverse events. ETHICS AND DISSEMINATION This study has been approved by the ethics committee (CPP Sud Est Paris V, France), and patients are included after informed consent. The results will be submitted for publication in peer-reviewed journals. As provided for by French law, patients participating in the study are informed that they have the possibility to ask the investigators, once the study is completed, to be informed of the overall results of the study. Thus, a summary of the results will be sent by post to the participants on request. TRIAL REGISTRATION NUMBER ClinicalTrials.gov Registry (NCT03829293).",2020,The prospect i ve multicentre randomised controlled) study is a multicentre randomised controlled trial comparing HFNO to SOT during GIE (upper and/or lower) under deep sedation administered by anaesthesiologists in the procedure room.,['Three hundred and eighty patients'],"['High-flow nasal oxygenation versus standard oxygenation', 'HFNO', 'High-flow nasal oxygenation (HFNO', 'Standard oxygen therapy (SOT']","['occurrence of hypoxaemia, defined by a pulse oximetry measurement of peripheral capillary oxygen saturation (SpO 2 ', 'prolonged hypoxaemia, severe hypoxaemia, need for manoeuvres to maintain upper airway patency and other adverse events', 'incidence of hypoxaemia']","[{'cui': 'C4319693', 'cui_str': 'Three hundred and eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}]","[{'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0034108', 'cui_str': 'Oximetry, Pulse'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C2711376', 'cui_str': 'ScO2 - Capillary oxygen saturation'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",380.0,0.118983,The prospect i ve multicentre randomised controlled) study is a multicentre randomised controlled trial comparing HFNO to SOT during GIE (upper and/or lower) under deep sedation administered by anaesthesiologists in the procedure room.,"[{'ForeName': 'Axelle', 'Initials': 'A', 'LastName': 'Eugene', 'Affiliation': 'Anaesthesiology and Critical Care Medicine, Centre Hospitalier Régional Universitaire de Tours, Tours, France.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Fromont', 'Affiliation': 'Anaesthesiology and Critical Care Medicine, Centre Hospitalier Régional Universitaire de Tours, Tours, France.'}, {'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Auvet', 'Affiliation': ""Medical Intensive Care Unit, Hospital Dax Côte d'Argent, Dax, France.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Baert', 'Affiliation': 'Anaesthesiology, Oréliance Health Centre, Saran, France.'}, {'ForeName': 'Willy-Serge', 'Initials': 'WS', 'LastName': 'Mfam', 'Affiliation': ""Anaesthesiology and Critical Care Medicine, Centre Hospitalier Régional d'Orleans, Orleans, France.""}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Remerand', 'Affiliation': 'Anaesthesiology and Critical Care Medicine, Centre Hospitalier Régional Universitaire de Tours, Tours, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Boulain', 'Affiliation': ""Medical Intensive Care Unit, Centre Hospitalier Régional d'Orleans, Orleans, France.""}, {'ForeName': 'Mai-Anh', 'Initials': 'MA', 'LastName': 'Nay', 'Affiliation': ""Medical Intensive Care Unit, Centre Hospitalier Régional d'Orleans, Orleans, France mai-anh.nay@chr-orleans.fr.""}]",BMJ open,['10.1136/bmjopen-2019-034701'] 256,32162321,Use of an intraoperative wound protector to prevent surgical-site infection after pancreatoduodenectomy: randomized clinical trial.,"BACKGROUND Surgical-site infection (SSI) increases treatment costs, duration of hospital stay and readmission rate after pancreatic surgery. This study aimed to assess whether a wound protector could reduce the risk of superficial incisional SSI after pancreatoduodenectomy. METHODS This RCT included patients undergoing pancreatoduodenectomy at Verona University Hospital, between 2017 and 2018. The experimental group had a dual-ring wound protector, whereas the control group had standard surgical drapes. The groups were stratified by preoperative biliary stent placement. The primary outcome was the overall rate of superficial SSI. RESULTS An interim analysis was conducted after 212 patients had been enrolled; 22 patients (10·4 per cent) were excluded owing to inability to complete the pancreatoduodenectomy, or the need for postoperative reintervention. Some 94 patients (49·5 per cent) had a wound protector and 96 (50·5 per cent) had standard drapes. There were no differences between groups in demographics, or in intraoperative findings, pathological data or surgical outcomes. The overall superficial SSI rate was 7·4 per cent, which did not differ between groups (7 per cent in each group; P = 0·585). Subanalysis of patients with a preoperative biliary stent showed a similar outcome (superficial SSI rate 9 versus 8 per cent with wound protector versus surgical drapes respectively; P = 0·536). The trial was stopped prematurely on the grounds of futility. CONCLUSION Use of a wound protector did not reduce the rate of superficial SSI after pancreatoduodenectomy. Registration number: NCT03820648 (http://www.clinicaltrials.gov).",2020,"The overall superficial SSI rate was 7·4 per cent, which did not differ between groups (7 per cent in each group; P = 0·585).","['patients undergoing pancreatoduodenectomy at Verona University Hospital, between 2017 and 2018', '212 patients had been enrolled; 22 patients (10·4 per cent) were excluded owing to inability to complete the pancreatoduodenectomy, or the need for postoperative reintervention', 'after pancreatic surgery']","['preoperative biliary stent placement', 'intraoperative wound protector', 'dual-ring wound protector', 'control group had standard surgical drapes', 'wound protector']","['treatment costs, duration of hospital stay and readmission rate', 'overall superficial SSI rate', 'similar outcome (superficial SSI rate', 'rate of superficial SSI', 'risk of superficial incisional SSI', 'overall rate of superficial SSI', 'intraoperative findings, pathological data or surgical outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0562018', 'cui_str': 'cent (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0183512', 'cui_str': 'Biliary stent (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C1260969', 'cui_str': 'Ring, device (physical object)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0180511', 'cui_str': 'Surgical Drapes'}]","[{'cui': 'C0087112', 'cui_str': 'Treatment Costs'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]",,0.26657,"The overall superficial SSI rate was 7·4 per cent, which did not differ between groups (7 per cent in each group; P = 0·585).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'De Pastena', 'Affiliation': 'Department of General and Pancreatic Surgery, Pancreas Institute, University and Hospital Trust of Verona, Policlinico GB Rossi, Piazzale L.A. Scuro, 10, 37134, Verona, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Marchegiani', 'Affiliation': 'Department of General and Pancreatic Surgery, Pancreas Institute, University and Hospital Trust of Verona, Policlinico GB Rossi, Piazzale L.A. Scuro, 10, 37134, Verona, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Paiella', 'Affiliation': 'Department of General and Pancreatic Surgery, Pancreas Institute, University and Hospital Trust of Verona, Policlinico GB Rossi, Piazzale L.A. Scuro, 10, 37134, Verona, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fontana', 'Affiliation': 'Department of General and Pancreatic Surgery, Pancreas Institute, University and Hospital Trust of Verona, Policlinico GB Rossi, Piazzale L.A. Scuro, 10, 37134, Verona, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Esposito', 'Affiliation': 'Department of General and Pancreatic Surgery, Pancreas Institute, University and Hospital Trust of Verona, Policlinico GB Rossi, Piazzale L.A. Scuro, 10, 37134, Verona, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Casetti', 'Affiliation': 'Department of General and Pancreatic Surgery, Pancreas Institute, University and Hospital Trust of Verona, Policlinico GB Rossi, Piazzale L.A. Scuro, 10, 37134, Verona, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Secchettin', 'Affiliation': 'Department of General and Pancreatic Surgery, Pancreas Institute, University and Hospital Trust of Verona, Policlinico GB Rossi, Piazzale L.A. Scuro, 10, 37134, Verona, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Manzini', 'Affiliation': 'Department of General and Pancreatic Surgery, Pancreas Institute, University and Hospital Trust of Verona, Policlinico GB Rossi, Piazzale L.A. Scuro, 10, 37134, Verona, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bassi', 'Affiliation': 'Department of General and Pancreatic Surgery, Pancreas Institute, University and Hospital Trust of Verona, Policlinico GB Rossi, Piazzale L.A. Scuro, 10, 37134, Verona, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Salvia', 'Affiliation': 'Department of General and Pancreatic Surgery, Pancreas Institute, University and Hospital Trust of Verona, Policlinico GB Rossi, Piazzale L.A. Scuro, 10, 37134, Verona, Italy.'}]",The British journal of surgery,['10.1002/bjs.11527'] 257,32044165,Randomized clinical trial on reduction of radiotherapy dose to the elective neck in head and neck squamous cell carcinoma; update of the long-term tumor outcome.,"BACKGROUND AND PURPOSE A multicenter prospective randomized controlled trial was performed to investigate whether dose reduction to the elective nodal volume (PTVelect) in head and neck carcinoma reduces radiation-induced dysphagia, primary endpoint, without compromising tumor control, secondary endpoint. Here, we report on the long-term follow-up of the secondary endpoint (NCT01812486). MATERIALS AND METHODS Two hundred patients treated with primary (chemo)radiotherapy (RT) were randomized (1:1) between the standard arm, irradiation to PTVelect up to an equivalent dose (EQD2) of 50 Gy and the experimental arm, irradiation to PTVelect up to EQD2 of 40 Gy. The primary tumor and involved nodes were treated according to the standard of care, EQD2 70 Gy (PTVhigh). Regional recurrences (RR) were projected on the initial RT planning-CT to identify the recurrence localization. RESULTS The 5-year (5Y) RR was 14.0% (CI95% 7.9; 21.8) in the 40 Gy arm versus 7.5% (CI95% 3.3; 14.0) in the 50 Gy arm (p = 0.10). Majority of RR in the 40 Gy arm (9/13) were projected in PTVhigh and 2 RR were seen outside the treated RT volume. Only 2 RR occurred in PTVelect irradiated up to 40 Gy which was the same number as RR occurring in the 50 Gy PTVelect. The 5Y-overall survival (OS) was 56.5% (CI95% 45.7; 65.9) in the 40 Gy arm versus 49.6% (CI95% 39.0; 59.2) in the 50 Gy arm (p = 0.56). CONCLUSION At 5-years, no statistically significant differences regarding OS, local recurrence, RR nor distant metastases were observed between both treatment arms. This study is underpowered to undoubtedly demonstrate non-inferiority. However, since in both arms only two RR in the PTVelect were observed, reducing the dose to PTVelect appears safe and should be further investigated.",2020,"At 5-years, no statistically significant differences regarding OS, local recurrence, RR nor distant metastases were observed between both treatment arms.","['Two hundred patients treated with primary (chemo)radiotherapy (RT', 'head and neck squamous cell carcinoma', 'head and neck carcinoma']","['irradiation to PTVelect up to an equivalent dose (EQD2) of 50\xa0Gy and the experimental arm, irradiation to PTVelect up to EQD2 of 40\xa0Gy', 'radiotherapy']","['overall survival (OS', 'OS, local recurrence, RR nor distant metastases', '5-year (5Y) RR', 'Regional recurrences (RR']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck (disorder)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0007097', 'cui_str': 'Epithelioma'}]","[{'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]",200.0,0.0991207,"At 5-years, no statistically significant differences regarding OS, local recurrence, RR nor distant metastases were observed between both treatment arms.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Deschuymer', 'Affiliation': 'Department of Radiation Oncology, KU Leuven - University of Leuven, University Hospitals Leuven, Belgium.'}, {'ForeName': 'Daan', 'Initials': 'D', 'LastName': 'Nevens', 'Affiliation': 'Department of Radiation Oncology, Iridium Kanker Netwerk, University of Antwerp, Faculty of Medicine and Health Sciences, Belgium.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Duprez', 'Affiliation': 'Department of Radiotherapy-Oncology, Ghent University Hospital, Belgium.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Daisne', 'Affiliation': 'Department of Radiation Oncology, Université Catholique de Louvain, CHU-UCL-Namur, Site Ste-Elisabeth, Belgium.'}, {'ForeName': 'Rüveyda', 'Initials': 'R', 'LastName': 'Dok', 'Affiliation': 'Laboratory of Experimental Radiotherapy, Department of Oncology, KU Leuven - University of Leuven, Belgium.'}, {'ForeName': 'Annouschka', 'Initials': 'A', 'LastName': 'Laenen', 'Affiliation': 'Leuven Biostatistics and Statistical Bioinformatics Center, University of Leuven, Belgium.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Voordeckers', 'Affiliation': 'Department of Radiation Oncology, UZ Brussel, Vrije Universiteit Brussel, Belgium.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'De Neve', 'Affiliation': 'Department of Radiotherapy-Oncology, Ghent University Hospital, Belgium.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Nuyts', 'Affiliation': 'Department of Radiation Oncology, KU Leuven - University of Leuven, University Hospitals Leuven, Belgium; Laboratory of Experimental Radiotherapy, Department of Oncology, KU Leuven - University of Leuven, Belgium. Electronic address: Sandra.nuyts@uzleuven.be.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.01.005'] 258,32164439,"Prevalence, Symptom Burden, and Underdiagnosis of Chronic Obstructive Pulmonary Disease in a Lung Cancer Screening Cohort.","Rationale: Individuals eligible for lung cancer screening (LCS) by low-dose computed tomography (LDCT) are also at risk of chronic obstructive pulmonary disease (COPD) due to age and smoking exposure. Whether the LCS episode is useful for early detection of COPD is not well established. Objectives: To explore associations between symptoms, comorbidities, spirometry, and emphysema in participants enrolled in the Lung Screen Uptake Trial. Methods: This cross-sectional study was a prespecified analysis nested within Lung Screen Uptake Trial, which was a randomized study testing the impact of differing invitation materials on attendance of 60- to 75-year-old smokers and ex-smokers to a ""lung health check"" between November 2015 and July 2017. Participants with a smoking history ≥30 pack-years and who quit ≤15 years ago, or meeting a lung cancer risk of ≥1.51% via the Prostate Lung Colorectal Ovarian model or ≥2.5% via the Liverpool Lung Project model, were offered LDCT. COPD was defined and classified according to the GOLD (Global Initiative for Obstructive Lung Disease) criteria using prebronchodilator spirometry. Analyses included the use of descriptive statistics, chi-square tests to examine group differences, and univariable and multivariable logistic regression to explore associations between symptom prevalence, airflow limitation, and visually graded emphysema. Results: A total of 560 of 986 individuals included in the analysis (57%) had prebronchodilator spirometry consistent with COPD; 67% did not have a prior history of COPD and were termed ""undiagnosed."" Emphysema prevalence in those with known and ""undiagnosed"" COPD was 73% and 68%, respectively. A total of 32% of those with ""undiagnosed COPD"" had no emphysema on LDCT. Inhaler use and symptoms were more common in the ""known"" than the ""undiagnosed"" COPD group (63% vs. 33% with persistent cough [ P  < 0.001]; 73% vs. 33% with dyspnea [ P  < 0.001]). Comorbidities were common in all groups. Adjusted odds ratio (aOR) of respiratory symptoms were more significant for airflow obstruction (aOR GOLD 1 and 2, 1.57; confidence interval [CI], 1.14-2.17; aOR GOLD 3 and 4, 4.6; CI, 2.17-9.77) than emphysema (aOR mild, 1.12; CI, 0.81-1.55; aOR moderate, 1.33; CI, 0.85-2.09; aOR severe, 4.00; CI, 1.57-10.2). Conclusions: There is high burden of ""undiagnosed COPD"" and emphysema in LCS participants. Adding spirometry findings to the LDCT enhances identification of individuals with COPD.Clinical trial registered with www.clinicaltrials.gov (NCT02558101).",2020,"Inhaler use and symptoms were more common in the 'known' than the 'undiagnosed' COPD group (63% vs. 33% with persistent cough [p<0.001], 73% vs. 33% with dyspnoea [p<0.001]).","['560 of 986 individuals included in the analysis (57%) had pre-bronchodilator spirometry consistent with COPD', 'Individuals eligible for lung cancer screening (LCS) by low-dose', ""60-75 year-old smokers and ex-smokers to a 'lung health check' between November 2015 and July 2017"", 'individuals with COPD', 'participants enrolled in the Lung Screen Uptake Trial (LSUT', 'Participants with a smoking history ≥30 pack-years and quit ≤15 years ago, or meeting a lung cancer risk of ≥1.51% via the Prostate Lung Colorectal Ovarian (PLCOm2012) model or ≥2.5% via the Liverpool Lung Project (LLP) model, were offered LDCT']","['LDCT', 'computed tomography (LDCT']","['Emphysema prevalence', 'Prevalence, Symptom Burden and Under-Diagnosis of Chronic Obstructive Pulmonary Disease', 'symptom prevalence, airflow limitation and visually graded emphysema', 'airflow obstruction']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilators'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0332290', 'cui_str': 'Consistent with (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0281477', 'cui_str': 'Lung cancer screening (procedure)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4555205', 'cui_str': 'Ex-Smokers'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C1277691', 'cui_str': 'Pack years'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1444648', 'cui_str': 'Offered'}]","[{'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0013990', 'cui_str': 'Emphysema'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0231999', 'cui_str': 'Airflow, function (observable entity)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]",,0.146541,"Inhaler use and symptoms were more common in the 'known' than the 'undiagnosed' COPD group (63% vs. 33% with persistent cough [p<0.001], 73% vs. 33% with dyspnoea [p<0.001]).","[{'ForeName': 'Mamta', 'Initials': 'M', 'LastName': 'Ruparel', 'Affiliation': 'Lungs for Living Research Centre, University College London (UCL) Respiratory.'}, {'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Quaife', 'Affiliation': 'Research Department of Behavioural Science and Health.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Dickson', 'Affiliation': 'Lungs for Living Research Centre, University College London (UCL) Respiratory.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Horst', 'Affiliation': 'Lungs for Living Research Centre, University College London (UCL) Respiratory.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Tisi', 'Affiliation': 'Lungs for Living Research Centre, University College London (UCL) Respiratory.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hall', 'Affiliation': 'Lungs for Living Research Centre, University College London (UCL) Respiratory.'}, {'ForeName': 'Magali N', 'Initials': 'MN', 'LastName': 'Taylor', 'Affiliation': 'Department of Radiology and.'}, {'ForeName': 'Asia', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Department of Radiology and.'}, {'ForeName': 'Penny J', 'Initials': 'PJ', 'LastName': 'Shaw', 'Affiliation': 'Department of Radiology and.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Burke', 'Affiliation': 'Department of Radiology and.'}, {'ForeName': 'May-Jan', 'Initials': 'MJ', 'LastName': 'Soo', 'Affiliation': 'Department of Radiology and.'}, {'ForeName': 'Arjun', 'Initials': 'A', 'LastName': 'Nair', 'Affiliation': 'Department of Radiology and.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Devaraj', 'Affiliation': 'Department of Radiology, Royal Brompton Hospital, London, United Kingdom.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Sennett', 'Affiliation': 'Killick Street Health Centre, London, United Kingdom.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Hurst', 'Affiliation': 'UCL Centre for Inflammation and Repair, University College London, London, United Kingdom.'}, {'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Duffy', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry, Queen Mary University, London, United Kingdom; and.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Navani', 'Affiliation': 'Lungs for Living Research Centre, University College London (UCL) Respiratory.'}, {'ForeName': 'Angshu', 'Initials': 'A', 'LastName': 'Bhowmik', 'Affiliation': 'Department of Thoracic Medicine, Homerton University Hospital, London, United Kingdom.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Baldwin', 'Affiliation': 'Respiratory Medicine Unit, David Evans Research Centre, Nottingham University Hospitals, Nottingham, United Kingdom.'}, {'ForeName': 'Sam M', 'Initials': 'SM', 'LastName': 'Janes', 'Affiliation': 'Lungs for Living Research Centre, University College London (UCL) Respiratory.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201911-857OC'] 259,32066607,"Effectiveness of a culturally adapted biopsychosocial intervention (POHON SIHAT) in improving self-efficacy in patients with diabetes attending primary healthcare clinics in Putrajaya, Malaysia: study protocol of a randomised controlled trial.","INTRODUCTION People with diabetes are often associated with multifaceted factors and comorbidities. Diabetes management frameworks need to integrate a biopsychosocial, patient-centred approach. Despite increasing efforts in promotion and diabetes education, interventions integrating both physical and mental health components are still lacking in Malaysia. The Optimal Health Programme (OHP) offers an innovative biopsychosocial framework to promote overall well-being and self-efficacy, going beyond education alone and has been identified as relevant within the primary care system. Following a comprehensive cultural adaptation process, Malaysia's first OHP was developed under the name 'Pohon Sihat' (OHP). The study aims to evaluate the effectiveness of the mental health-based self-management and wellness programme in improving self-efficacy and well-being in primary care patients with diabetes mellitus. METHODS AND ANALYSIS This biopsychosocial intervention randomised controlled trial will engage patients (n=156) diagnosed with type 2 diabetes mellitus (T2DM) from four primary healthcare clinics in Putrajaya. Participants will be randomised to either OHP plus treatment as usual. The 2-hour weekly sessions over five consecutive weeks, and 2-hour booster session post 3 months will be facilitated by trained mental health practitioners and diabetes educators. Primary outcomes will include self-efficacy measures, while secondary outcomes will include well-being, anxiety, depression, self-care behaviours and haemoglobin A1c glucose test. Outcome measures will be assessed at baseline, immediately postintervention, as well as at 3 months and 6 months postintervention. Where appropriate, intention-to-treat analyses will be performed. ETHICS AND DISSEMINATION This study has ethics approval from the Medical Research and Ethics Committee, Ministry of Health Malaysia (NMRR-17-3426-38212). Study findings will be shared with the Ministry of Health Malaysia and participating healthcare clinics. Outcomes will also be shared through publication, conference presentations and publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER NCT03601884.",2020,"The study aims to evaluate the effectiveness of the mental health-based self-management and wellness programme in improving self-efficacy and well-being in primary care patients with diabetes mellitus. ","['patients with diabetes attending primary healthcare clinics in Putrajaya, Malaysia', 'primary care patients with diabetes mellitus', 'engage patients (n=156) diagnosed with type 2 diabetes mellitus (T2DM) from four primary healthcare clinics in Putrajaya']","['Health Programme (OHP', 'culturally adapted biopsychosocial intervention (POHON SIHAT', 'OHP', 'mental health-based self-management and wellness programme']","['self-efficacy measures, while secondary outcomes will include well-being, anxiety, depression, self-care behaviours and haemoglobin A1c glucose test']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0024552', 'cui_str': 'Federation of Malaya'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior (finding)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",,0.124889,"The study aims to evaluate the effectiveness of the mental health-based self-management and wellness programme in improving self-efficacy and well-being in primary care patients with diabetes mellitus. ","[{'ForeName': 'Aida Farhana', 'Initials': 'AF', 'LastName': 'Suhaimi', 'Affiliation': 'Department of Psychiatry and Mental Health, Hospital Putrajaya Malaysia, Selangor, Malaysia aida.hjsuhaimi@gmail.com.'}, {'ForeName': 'Normala', 'Initials': 'N', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Psychiatry, Universiti Putra Malaysia, Faculty of Medicine and Health Sciences, Serdang, Malaysia.'}, {'ForeName': 'Kit-Aun', 'Initials': 'KA', 'LastName': 'Tan', 'Affiliation': 'Department of Psychiatry, Universiti Putra Malaysia, Faculty of Medicine and Health Sciences, Serdang, Malaysia.'}, {'ForeName': 'Umi Adzlin', 'Initials': 'UA', 'LastName': 'Silim', 'Affiliation': 'Department of Psychiatry and Mental Health, Hospital Kuala Lumpur, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Gaye', 'Initials': 'G', 'LastName': 'Moore', 'Affiliation': ""Centre for Palliative Care, St. Vincent's Hospital Melbourne, Melbourne, Victoria, Australia.""}, {'ForeName': 'Brigid', 'Initials': 'B', 'LastName': 'Ryan', 'Affiliation': ""International Unit, St. Vincent's Hospital Melbourne, Melbourne, Victoria, Australia.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Castle', 'Affiliation': ""Department of Psychiatry, St. Vincent's Mental Health, Melbourne, Victoria, Australia.""}]",BMJ open,['10.1136/bmjopen-2019-033920'] 260,32066608,Comparative study of treatment interventions for patellar tendinopathy: a protocol for a randomised controlled trial.,"INTRODUCTION Patellar tendinopathy is a degenerative disease of the patellar tendon, which affects athletes from a variety of sports, and is especially predominant in sports involving high-impact jumping. The aim of this study is to determine the additional effect of two interventions combined with eccentric exercise and compare which one is the most effective at short-term and long-term follow-up for patients with patellar tendinopathy. METHODS AND ANALYSIS This study is a randomised controlled trial with blinded participants. Measurements will be carried out by a specially trained blinded assessor. A sample of 57 patients with a medical diagnosis of patellar tendinopathy will participate in this study and will be divided into three treatment groups. Eligible participants will be randomly allocated to receive either: (a) treatment group with percutaneous needle electrolysis, (b) treatment group with dry needling or (c) treatment group with placebo needling. In addition, all groups will perform eccentric exercise. Functionality and muscle strength parameters, pain, ultrasound appearances and patient perceived quality of life shall be evaluated using the Victorian Institute of Sports Assessment for patellar (VISA-P), jump tests, Visual Analogue Scale, ultrasound images and Short Form-36 (SF-36), respectively. Participants will be assessed at baseline, at 10 weeks and at 22 weeks after baseline. The expected findings will allow us to advance in the treatment of this injury, as they will help determine whether a needling intervention has additional effects on an eccentric exercise programme and whether any of the needling modalities is more effective than the other. ETHICS AND DISSEMINATION This protocol has been approved by the Ethics Committee of Aragon (N° PI15/0017). The trial will be conducted in accordance with the Declaration of Helsinki. TRIAL REGISTRATION NUMBER NCT02498795.",2020,"Functionality and muscle strength parameters, pain, ultrasound appearances and patient perceived quality of life shall be evaluated using the Victorian Institute of Sports Assessment for patellar (VISA-P), jump tests, Visual Analogue Scale, ultrasound images and Short Form-36 (SF-36), respectively.","['patients with patellar tendinopathy', 'Eligible participants', 'patellar tendinopathy', '57 patients with a medical diagnosis of patellar tendinopathy']","['eccentric exercise', 'percutaneous needle electrolysis, (b) treatment group with dry needling or (c) treatment group with placebo needling']","['Functionality and muscle strength parameters, pain, ultrasound appearances and patient perceived quality of life shall be evaluated using the Victorian Institute of Sports Assessment for patellar (VISA-P), jump tests, Visual Analogue Scale, ultrasound images and Short Form-36 (SF-36']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1568272', 'cui_str': 'Tendinopathy'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]","[{'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0013829', 'cui_str': 'Electrolysis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034380'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1318881', 'cui_str': 'Infection due to vancomycin intermediate Staphylococcus aureus'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}]",57.0,0.19379,"Functionality and muscle strength parameters, pain, ultrasound appearances and patient perceived quality of life shall be evaluated using the Victorian Institute of Sports Assessment for patellar (VISA-P), jump tests, Visual Analogue Scale, ultrasound images and Short Form-36 (SF-36), respectively.","[{'ForeName': 'Maria Pilar', 'Initials': 'MP', 'LastName': 'López-Royo', 'Affiliation': 'iPhysio Research Group, Facultad de Ciencias de la Salud. Universidad San Jorge, Villanueva de Gallego, Aragón, Spain.'}, {'ForeName': 'Eva Maria', 'Initials': 'EM', 'LastName': 'Gómez-Trullén', 'Affiliation': 'Facultad de Ciencias de la Salud y del Deporte, Universidad de Zaragoza, Campus de Huesca, Aragón, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ortiz-Lucas', 'Affiliation': 'iPhysio Research Group, Facultad de Ciencias de la Salud. Universidad San Jorge, Villanueva de Gallego, Aragón, Spain.'}, {'ForeName': 'Rita Maria', 'Initials': 'RM', 'LastName': 'Galán-Díaz', 'Affiliation': 'iPhysio Research Group, Facultad de Ciencias de la Salud. Universidad San Jorge, Villanueva de Gallego, Aragón, Spain.'}, {'ForeName': 'Ana Vanessa', 'Initials': 'AV', 'LastName': 'Bataller-Cervero', 'Affiliation': 'iPhysio Research Group, Facultad de Ciencias de la Salud. Universidad San Jorge, Villanueva de Gallego, Aragón, Spain.'}, {'ForeName': 'Zaid', 'Initials': 'Z', 'LastName': 'Al-Boloushi', 'Affiliation': 'iPhysio Research Group, Facultad de Ciencias de la Salud. Universidad San Jorge, Villanueva de Gallego, Aragón, Spain.'}, {'ForeName': 'Yasmina', 'Initials': 'Y', 'LastName': 'Hamam-Alcober', 'Affiliation': 'iPhysio Research Group, Facultad de Ciencias de la Salud. Universidad San Jorge, Villanueva de Gallego, Aragón, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Herrero', 'Affiliation': 'iPhysio Research Group, Facultad de Ciencias de la Salud. Universidad San Jorge, Villanueva de Gallego, Aragón, Spain pherrero@usj.es.'}]",BMJ open,['10.1136/bmjopen-2019-034304'] 261,32029495,"NET-02 trial protocol: a multicentre, randomised, parallel group, open-label, phase II, single-stage selection trial of liposomal irinotecan (nal-IRI) and 5-fluorouracil (5-FU)/folinic acid or docetaxel as second-line therapy in patients with progressive poorly differentiated extrapulmonary neuroendocrine carcinoma (NEC).","INTRODUCTION Poorly differentiated (PD), extrapulmonary (EP), neuroendocrine carcinomas (NECs) are rare but aggressive neuroendocrine neoplasms. First-line treatment for advanced disease is an etoposide and platinum-based chemotherapy combination. There is no established second-line treatment for patients with PD-EP-NEC, and this is an area of unmet need. METHODS AND ANALYSIS NET-02 is a UK, multicentre, randomised (1:1), parallel group, open-label, phase II, single-stage selection trial of liposomal irinotecan (nal-IRI)/5-fluorouracil (5-FU)/folinic acid or docetaxel as second-line therapy in patients with progressive PD-EP-NEC. One hundred and two eligible participants will be randomised to receive either nal-IRI/5-FU/folinic acid or docetaxel. The primary objective is to determine the 6-month progression-free survival (PFS) rate. The secondary objectives of this study are to determine PFS, overall survival, objective response rate, toxicity, quality of life and whether neuron-specific enolase is predictive of treatment response. If either treatment is found to have a 6-month PFS rate of at least 25%, that treatment will be considered for a phase III trial. If both treatments meet this target, prespecified selection criteria will be applied to establish which treatment to take forward. ETHICS AND DISSEMINATION This study has ethical approval from the Greater Manchester Central Research Ethics Committee (reference no. 18/NW/0031) and clinical trial authorisation from the Medicine and Healthcare Products Regulatory Agency. Results will be published in peer-reviewed journals and uploaded to the European Union Clinical Trials Register. TRIAL REGISTRATION NUMBERS ISRCTN10996604, NCT03837977, EudraCT Number: 2017-002453-11.",2020,"If either treatment is found to have a 6-month PFS rate of at least 25%, that treatment will be considered for a phase III trial.","['patients with progressive PD-EP-NEC', 'One hundred and two eligible participants', 'patients with progressive poorly differentiated extrapulmonary neuroendocrine carcinoma (NEC']","['liposomal irinotecan (nal-IRI) and 5-fluorouracil (5-FU)/folinic acid or docetaxel as second-line therapy', 'nal-IRI/5-FU/folinic acid or docetaxel', 'liposomal irinotecan (nal-IRI)/5-fluorouracil (5-FU)/folinic acid or docetaxel as second-line therapy', 'etoposide and platinum-based chemotherapy combination']","['PFS rate', 'PFS, overall survival, objective response rate, toxicity, quality of life', '6-month progression-free survival (PFS) rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0912341', 'cui_str': ""N'(OB)EC""}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated (qualifier value)'}, {'cui': 'C0206695', 'cui_str': 'Carcinoma, Neuroendocrine'}]","[{'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0034380'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",102.0,0.182193,"If either treatment is found to have a 6-month PFS rate of at least 25%, that treatment will be considered for a phase III trial.","[{'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Craig', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, West Yorkshire, UK.'}, {'ForeName': 'Jayne', 'Initials': 'J', 'LastName': 'Swain', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, West Yorkshire, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Batman', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, West Yorkshire, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Wadsley', 'Affiliation': 'Department of Oncology, Weston Park Hospital, Sheffield, Sheffield, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Reed', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, Glasgow, UK.'}, {'ForeName': 'Olusola', 'Initials': 'O', 'LastName': 'Faluyi', 'Affiliation': 'Clatterbridge Cancer Centre NHS Foundation Trust, Bebington, Wirral, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Cave', 'Affiliation': 'Department of Oncology, University Hospital Southampton NHS Foundation Trust, Southampton, Southampton, UK.'}, {'ForeName': 'Rohini', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, London, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Chau', 'Affiliation': 'Gastrointestinal and Lymphoma Unit, Royal Marsden Hospital NHS Trust, London, London, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Wall', 'Affiliation': 'Department of Oncology, Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Lamarca', 'Affiliation': 'Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hubner', 'Affiliation': 'Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Wasat', 'Initials': 'W', 'LastName': 'Mansoor', 'Affiliation': 'Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Debashis', 'Initials': 'D', 'LastName': 'Sarker', 'Affiliation': ""Comprehensive Cancer Centre, King's College Hospital, London, UK.""}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Meyer', 'Affiliation': 'Department of Oncology, University College London Cancer Institute, London, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Cairns', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, West Yorkshire, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Howard', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, West Yorkshire, UK.'}, {'ForeName': 'Juan W', 'Initials': 'JW', 'LastName': 'Valle', 'Affiliation': 'Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Mairéad G', 'Initials': 'MG', 'LastName': 'McNamara', 'Affiliation': 'Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK Mairead.McNamara@christie.nhs.uk.'}]",BMJ open,['10.1136/bmjopen-2019-034527'] 262,32029498,Trial protocol: preoperative administration of tranexamic acid in sleeve gastrectomy (PATAS) to reduce haemorrhage rates. A randomised controlled trial.,"INTRODUCTION Fast-track protocols often include short-term thromboprophylaxis and short length of hospital stay. These treatment strategies may negatively affect the occurrence and diagnosis of postoperative haemorrhage. Over the years, the rates of venous thromboembolic events (VTEs) have decreased, while there seems to be an increase in the occurrence of postoperative haemorrhage. Tranexamic acid (TXA) can potentially lower the incidence of postoperative haemorrhage. This trial aims to investigate whether preoperative administration of TXA reduces the preoperative and postoperative haemorrhage rates in laparoscopic sleeve gastrectomy (LSG). METHODS AND ANALYSIS This is a single centre double-blind randomised placebo-controlled trial. Patients undergoing an LSG are included after obtaining informed consent. Patients are randomised between two groups: (1) administration of placebo infusion and (2) administration of 1500 mg TXA. In both groups, the infusions will be administered during the induction phase of the procedure. Primary outcome measures are preoperative use of haemostatic clips, postoperative haemoglobin decrease and postoperative haemorrhage. Secondary outcome measure is the rates of VTE. ETHICS AND DISSEMINATION The protocol version 3 was approved by the medical ethical committee Medical Research Ethics Committees United (MEC-U), Nieuwegein, on 29 July 2019. The trial results will be submitted for publication in a peer-reviewed journal and at conference presentations. TRIAL REGISTRATION NUMBER The Netherlands Trial Registry (NL8029); Pre-results.",2020,"This trial aims to investigate whether preoperative administration of TXA reduces the preoperative and postoperative haemorrhage rates in laparoscopic sleeve gastrectomy (LSG). ",['Patients undergoing an LSG are included after obtaining informed consent'],"['TXA', 'tranexamic acid', 'Tranexamic acid (TXA', 'placebo infusion and (2) administration of 1500\u2009mg TXA', 'laparoscopic sleeve gastrectomy (LSG', 'placebo', 'sleeve gastrectomy (PATAS']","['rates of VTE', 'preoperative and postoperative haemorrhage rates', 'rates of venous thromboembolic events (VTEs', 'preoperative use of haemostatic clips, postoperative haemoglobin decrease and postoperative haemorrhage', 'haemorrhage rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}]","[{'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low (finding)'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}]",,0.447315,"This trial aims to investigate whether preoperative administration of TXA reduces the preoperative and postoperative haemorrhage rates in laparoscopic sleeve gastrectomy (LSG). ","[{'ForeName': 'Marjolijn', 'Initials': 'M', 'LastName': 'Leeman', 'Affiliation': 'Surgery, Franciscus Gasthuis en Vlietland, Rotterdam, The Netherlands m.leeman@franciscus.nl.'}, {'ForeName': 'Jeannine', 'Initials': 'J', 'LastName': 'Huisbrink', 'Affiliation': 'Pharmacology, Franciscus Gasthuis en Vlietland, Rotterdam, The Netherlands.'}, {'ForeName': 'Julie M A', 'Initials': 'JMA', 'LastName': 'Wijnand', 'Affiliation': 'Surgery, Franciscus Gasthuis en Vlietland, Rotterdam, The Netherlands.'}, {'ForeName': 'L Ulas', 'Initials': 'LU', 'LastName': 'Biter', 'Affiliation': 'Surgery, Franciscus Gasthuis en Vlietland, Rotterdam, The Netherlands.'}, {'ForeName': 'Serge J C', 'Initials': 'SJC', 'LastName': 'Verbrugge', 'Affiliation': 'Anaesthesiology, Franciscus Gasthuis en Vlietland, Rotterdam, The Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Dunkelgrun', 'Affiliation': 'Surgery, Franciscus Gasthuis en Vlietland, Rotterdam, The Netherlands.'}, {'ForeName': 'Jan A', 'Initials': 'JA', 'LastName': 'Apers', 'Affiliation': 'Surgery, Franciscus Gasthuis en Vlietland, Rotterdam, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2019-034572'] 263,32029497,Computerised cognitive training to improve cognition including delirium following coronary artery bypass grafting surgery: protocol for a blinded randomised controlled trial.,"INTRODUCTION Coronary artery bypass grafting (CABG) surgery is known to improve vascular function and cardiac-related mortality rates; however, it is associated with high rates of postoperative cognitive decline and delirium. Previous attempts to prevent post-CABG cognitive decline using pharmacological and surgical approaches have been largely unsuccessful. Cognitive prehabilitation and rehabilitation are a viable yet untested option for CABG patients. We aim to investigate the effects of preoperative cognitive training on delirium incidence, and preoperative and postoperative cognitive training on cognitive decline at 4 months post-CABG. METHODS AND ANALYSIS This study is a randomised, single-blinded, controlled trial investigating the use of computerised cognitive training (CCT) both pre-CABG and post-CABG (intervention group) compared with usual care (control group) in older adults undergoing CABG in Adelaide, South Australia. Those in the intervention group will complete 1-2 weeks of CCT preoperatively (45-60 min sessions, 3.5 sessions/week) and 12 weeks of CCT postoperatively (commencing 1 month following surgery, 45-60 min sessions, 3 sessions/week). All participants will undergo cognitive testing preoperatively, over their hospital stay including delirium, and postoperatively for up to 1 year. The primary delirium outcome variable will be delirium incidence (presence vs absence); the primary cognitive decline variable will be at 4 months (significant decline vs no significant decline/improvement from baseline). Logistic regression modelling will be used, with age and gender as covariates. Secondary outcomes include cognitive decline from baseline to discharge, and at 6 months and 1 year post-CABG. ETHICS AND DISSEMINATION Ethics approval was obtained from the Central Adelaide Local Health Network Human Research Ethics Committee (South Australia, Australia) and the University of South Australia Human Ethics Committee, with original approval obtained on 13 December 2017. It is anticipated that approximately two to four publications and multiple conference presentations (national and international) will result from this research. TRIAL REGISTRATION NUMBER This clinical trial is registered with the Australian New Zealand Clinical Trials Registry and relates to the pre-results stage. Registration number: ACTRN12618000799257.",2020,"This study is a randomised, single-blinded, controlled trial investigating the use of computerised cognitive training (CCT) both pre-CABG and post-CABG (intervention group) compared with usual care (control group) in older adults undergoing CABG in Adelaide, South Australia.","['older adults undergoing CABG in Adelaide, South Australia', 'Registration number', 'CABG patients', 'All participants will undergo cognitive testing preoperatively, over their hospital stay including delirium, and postoperatively for up to 1\u2009year']","['Coronary artery bypass grafting (CABG) surgery', 'Computerised cognitive training', 'computerised cognitive training (CCT) both pre-CABG and post-CABG (intervention group) compared with usual care (control group', 'preoperative cognitive training', 'coronary artery bypass grafting surgery']","['delirium incidence (presence vs absence); the primary cognitive decline', 'cognition including delirium', 'cognitive decline from baseline to discharge, and at 6\u2009months and 1\u2009year post-CABG']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0037715', 'cui_str': 'South Australia'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}]","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C1689985', 'cui_str': 'Absence'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0234985', 'cui_str': 'Cognitive Decline'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}]",,0.225326,"This study is a randomised, single-blinded, controlled trial investigating the use of computerised cognitive training (CCT) both pre-CABG and post-CABG (intervention group) compared with usual care (control group) in older adults undergoing CABG in Adelaide, South Australia.","[{'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Greaves', 'Affiliation': 'Cognitive Ageing and Impairment Neurosciences Laboratory (CAIN), School of Psychology, Social Work and Social Policy, University of South Australia Division of Education, Arts and Social Sciences, Adelaide, South Australia, Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Psaltis', 'Affiliation': 'Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Lampit', 'Affiliation': 'Academic Unit for Psychiatry of Old Age, Department of Psychiatry, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Daniel H J', 'Initials': 'DHJ', 'LastName': 'Davis', 'Affiliation': 'MRC Unit for Lifelong Health and Ageing, University College London, London, UK.'}, {'ForeName': 'Ashleigh E', 'Initials': 'AE', 'LastName': 'Smith', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity (ARENA), University of South Australia Division of Health Sciences, Adelaide, South Australia, Australia.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Bourke', 'Affiliation': 'Department of Geriatric and Rehabilitation Medicine, Royal Adelaide Hospital, Central Adelaide Local Health Network, Adelaide, South Australia, Australia.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Worthington', 'Affiliation': 'Department of Cardiothoracic Surgery, Royal Adelaide Hospital, Central Adelaide Local Health Network, Adelaide, South Australia, Australia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Valenzuela', 'Affiliation': 'Brain and Mind Centre and Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Hannah A D', 'Initials': 'HAD', 'LastName': 'Keage', 'Affiliation': 'Cognitive Ageing and Impairment Neurosciences Laboratory (CAIN), School of Psychology, Social Work and Social Policy, University of South Australia Division of Education, Arts and Social Sciences, Adelaide, South Australia, Australia Hannah.Keage@unisa.edu.au.'}]",BMJ open,['10.1136/bmjopen-2019-034551'] 264,32041861,Protocol for a feasibility study: a brief self-compassion intervention for adolescents with type 1 diabetes and disordered eating.,"INTRODUCTION Adolescents with type 1 diabetes are at a higher risk of developing psychiatric disorders, particularly eating disorders, compared with their healthy peers. In turn, this increases the risk for sub-optimal glycaemic control and life-threatening diabetes-related complications. Despite these increased risks, standard diabetes care does not routinely provide psychological support to help prevent or reduce mental health risks. There is an urgent need to develop 'clinically usable' psychosocial interventions that are acceptable to patients and can be realistically integrated into clinical care. This study aims to examine the feasibility and acceptability of a brief self-compassion intervention for adolescents with type 1 diabetes and disordered eating behaviour. METHODS AND ANALYSIS This feasibility study will examine the effectiveness of a brief self-compassion intervention, compared with a waitlist control group. Participants aged 12-16 years will be recruited from three diabetes outpatient clinics in Auckland, New Zealand. The brief self-compassion intervention is adapted from the standardised 'Making Friends with Yourself' intervention and will be delivered in a group format over two sessions. Apart from examining feasibility and acceptability through the flow of participants through the study and qualitative questions, we will assess changes to disordered eating behaviour (primary outcome), self-care behaviours, diabetes-related distress, self-compassion, stress and glycaemic control (secondary outcomes). Such data will be used to calculate the required sample size for a fully powered randomised controlled trial. ETHICS AND DISSEMINATION This trial has received ethics approval from the Health and Disability Ethics Committee (research project number A+8467). Study results will be disseminated through peer-reviewed journals and conferences. TRIAL REGISTRATION NUMBER ANZCTR (12619000541101).",2020,"This feasibility study will examine the effectiveness of a brief self-compassion intervention, compared with a waitlist control group.","['adolescents with type 1 diabetes and disordered eating', 'Participants aged 12-16 years will be recruited from three diabetes outpatient clinics in Auckland, New Zealand', 'Adolescents with type 1 diabetes', 'adolescents with type 1 diabetes and disordered eating behaviour']","['brief self-compassion intervention', 'self-compassion intervention']","['feasibility and acceptability', 'disordered eating behaviour (primary outcome), self-care behaviours, diabetes-related distress, self-compassion, stress and glycaemic control (secondary outcomes']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior (finding)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",,0.112588,"This feasibility study will examine the effectiveness of a brief self-compassion intervention, compared with a waitlist control group.","[{'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Boggiss', 'Affiliation': 'Department of Psychological Medicine, The University of Auckland Faculty of Medical and Health Sciences, Auckland, New Zealand abog579@aucklanduni.ac.nz.'}, {'ForeName': 'Nathan S', 'Initials': 'NS', 'LastName': 'Consedine', 'Affiliation': 'Department of Psychological Medicine, The University of Auckland Faculty of Medical and Health Sciences, Auckland, New Zealand.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Jefferies', 'Affiliation': ""Starship Children's Health, Auckland City Hospital, Auckland, New Zealand.""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Bluth', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Hofman', 'Affiliation': 'The Liggins Institute, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Anna S', 'Initials': 'AS', 'LastName': 'Serlachius', 'Affiliation': 'Department of Psychological Medicine, The University of Auckland Faculty of Medical and Health Sciences, Auckland, New Zealand.'}]",BMJ open,['10.1136/bmjopen-2019-034452'] 265,32024790,Triple-arm trial of pH (Tri-pH) effect on live birth after ICSI in Egyptian IVF facilities: protocol of a randomised controlled trial.,"INTRODUCTION One potential stressor that can affect preimplantation and postimplantation embryonic growth after in vitro fertilisation (IVF) is the pH of the human embryo culture medium, but no evidence exists to indicate which pH level is optimal for IVF. Based on anecdotal evidence or mouse models, culture media manufacturers recommend a pH range of 7.2 to 7.4, and IVF laboratories routinely use a pH range of 7.25 to 7.3. Given the lack of randomised trials evaluating the effect of pH on live birth rate after IVF, this trial examines the effect of three different pH levels on the live birth rate. METHODS AND ANALYSIS This multicentre randomised trial will involve centres specialised in IVF in Egypt. Eligible couples for intracytoplasmic sperm injection (ICSI) will be randomised for embryo culture at pH 7.2, 7.3 or 7.4. The study is designed to detect 10 percentage points difference in live birth rate between the best and worst performing media with 93% power at a 1% significance level. The primary outcome is the rate of live birth (delivery of one or more viable infants beyond the 20th week of gestation) after ICSI. Secondary clinical outcomes include biochemical pregnancy, clinical pregnancy, ongoing pregnancy, miscarriage, preterm births, birth weight, stillbirth, congenital malformation and cumulative live birth (within 1 year from randomisation). Embryo development outcomes include fertilisation, blastocyst formation and quality, and embryo cryopreservation and utilisation. ETHICS AND DISSEMINATION The study was reviewed and approved by the Ethics Review Boards of the participating centres. Eligible women will sign a written informed consent before enrolment. This study has an independent data monitoring and safety committee comprised international experts in trial design and in vitro culture. No plan exists to disseminate results to participants or health communities, except for the independent monitoring and safety committee of the trial. TRIAL REGISTRATION NUMBER NCT02896777.",2020,"Secondary clinical outcomes include biochemical pregnancy, clinical pregnancy, ongoing pregnancy, miscarriage, preterm births, birth weight, stillbirth, congenital malformation and cumulative live birth (within 1 year from randomisation).",['live birth after ICSI in Egyptian IVF facilities'],"['pH', 'pH (Tri-pH', 'intracytoplasmic sperm injection (ICSI']","['rate of live birth (delivery of one or more viable infants beyond the 20th week of gestation', 'fertilisation, blastocyst formation and quality, and embryo cryopreservation and utilisation', 'biochemical pregnancy, clinical pregnancy, ongoing pregnancy, miscarriage, preterm births, birth weight, stillbirth, congenital malformation and cumulative live birth (within 1\u2009year from randomisation', 'live birth rate']","[{'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0337801', 'cui_str': 'Egyptians (ethnic group)'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}]","[{'cui': 'C0065404', 'cui_str': 'Tri (L)'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}]","[{'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0443348', 'cui_str': 'Viable (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0005705', 'cui_str': 'Embryo stage 3 structure'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0010405', 'cui_str': 'Cryofixation'}, {'cui': 'C0404845', 'cui_str': 'Biochemical pregnancy (finding)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0000768', 'cui_str': 'Birth Defects'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",,0.6584,"Secondary clinical outcomes include biochemical pregnancy, clinical pregnancy, ongoing pregnancy, miscarriage, preterm births, birth weight, stillbirth, congenital malformation and cumulative live birth (within 1 year from randomisation).","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Fawzy', 'Affiliation': 'Ibnsina IVF Centre, IbnSina Hospital, Sohag, Egypt drfawzy001@me.com.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Emad', 'Affiliation': 'Ibnsina IVF Centre, IbnSina Hospital, Sohag, Egypt.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Wilkinson', 'Affiliation': 'Centre for Biostatistics, University of Manchester, Manchester, UK.'}, {'ForeName': 'Ragaa', 'Initials': 'R', 'LastName': 'Mansour', 'Affiliation': 'Egyptian IVF-ET Center, Cairo, Egypt.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mahran', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Assiut University, Faculty of Medicine, Assiut, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Fetih', 'Affiliation': 'Department of Obstetrics and Gynecology, Assiut University, Faculty of Medicine, Assiut, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdelrahman', 'Affiliation': 'Department of Obstetrics and Gynecology, Sohag University, Faculty of Medicine, Sohag, Egypt.'}, {'ForeName': 'Hazem', 'Initials': 'H', 'LastName': 'AbdelGhafar', 'Affiliation': 'Department of Obstetrics and Gynecology, Sohag University, Faculty of Medicine, Sohag, Egypt.'}]",BMJ open,['10.1136/bmjopen-2019-034194'] 266,32029493,Ultrasound-guided superficial cervical plexus block for analgesia in patients undergoing craniotomy via suboccipital retrosigmoid approach: study protocol of a randomised controlled trial.,"INTRODUCTION Scalp nerve block has been proven to be an alternative choice to opioids in multimodal analgesia. However, for the infratentorial space-occupying craniotomy, especially the suboccipital retrosigmoid craniotomy, scalp nerve block is insufficient. METHODS AND ANALYSIS The study is a prospective, single-centre, randomised, paralleled-group controlled trial. Patients scheduled to receive elective suboccipital retrosigmoid craniotomy will be randomly assigned to the superficial cervical plexus block group or the control group. After anaesthesia induction, superficial cervical plexus nerve block will be performed under the guidance of ultrasound. The primary outcome is the cumulative consumption of sufentanil by the patient-controlled intravenous analgesia pump within 24 hours after surgery. Secondary outcomes include the cumulative consumption of sufentanil at other four time points and numerical rating scale pain severity score. ETHICS AND DISSEMINATION The protocol (version number: 2.0, 10 April 2019) has been approved by the Ethics Review Committee of China Registered Clinical Trials (Ethics Review No. ChiECRCT-20190047). The findings of this study will be disseminated in peer-reviewed journals and at scientific conferences. TRIAL REGISTRATION NUMBER NCT04036812.",2020,The primary outcome is the cumulative consumption of sufentanil by the patient-controlled intravenous analgesia pump within 24 hours after surgery.,['patients undergoing craniotomy via suboccipital retrosigmoid approach'],"['Ultrasound-guided superficial cervical plexus block for analgesia', 'elective suboccipital retrosigmoid craniotomy', 'superficial cervical plexus block group or the control group']","['cumulative consumption of sufentanil at other four time points and numerical rating scale pain severity score', 'cumulative consumption of sufentanil by the patient-controlled intravenous analgesia pump']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0442187', 'cui_str': 'Suboccipital approach (qualifier value)'}, {'cui': 'C0442178', 'cui_str': 'Retrosigmoid approach (qualifier value)'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0394691', 'cui_str': 'Superficial cervical plexus block (procedure)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0442187', 'cui_str': 'Suboccipital approach (qualifier value)'}, {'cui': 'C0442178', 'cui_str': 'Retrosigmoid approach (qualifier value)'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0222045'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0182537', 'cui_str': 'Pump'}]",,0.194922,The primary outcome is the cumulative consumption of sufentanil by the patient-controlled intravenous analgesia pump within 24 hours after surgery.,"[{'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Peng', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zeng', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Dexiang', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yuming', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China florapym766@163.com.'}]",BMJ open,['10.1136/bmjopen-2019-034003'] 267,32024793,Protocol for the process and feasibility evaluations of a new model of primary care service delivery for managing pain and function in patients with knee osteoarthritis (PARTNER) using a mixed methods approach.,"INTRODUCTION This protocol outlines the rationale, design and methods for the process and feasibility evaluations of the primary care management on knee pain and function in patients with knee osteoarthritis (PARTNER) study. PARTNER is a randomised controlled trial to evaluate a new model of service delivery (the PARTNER model) against 'usual care'. PARTNER is designed to encourage greater uptake of key evidence-based non-surgical treatments for knee osteoarthritis (OA) in primary care. The intervention supports general practitioners (GPs) to gain an understanding of the best management options available through online professional development. Their patients receive telephone advice and support for OA management by a centralised, multidisciplinary 'Care Support Team'. We will conduct concurrent process and feasibility evaluations to understand the implementation of this new complex health intervention, identify issues for consideration when interpreting the effectiveness outcomes and develop recommendations for future implementation, cost effectiveness and scalability. METHODS AND ANALYSIS The UK Medical Research Council Framework for undertaking a process evaluation of complex interventions and the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) frameworks inform the design of these evaluations. We use a mixed-methods approach including analysis of survey data, administrative records, consultation records and semistructured interviews with GPs and their enrolled patients. The analysis will examine fidelity and dose of the intervention, observations of trial setup and implementation and the quality of the care provided. We will also examine details of 'usual care'. The semistructured interviews will be analysed using thematic and content analysis to draw out themes around implementation and acceptability of the model. ETHICS AND DISSEMINATION The primary and substudy protocols have been approved by the Human Research Ethics Committee of The University of Sydney (2016/959 and 2019/503). Our findings will be disseminated to national and international partners and stakeholders, who will also assist with wider dissemination of our results across all levels of healthcare. Specific findings will be disseminated via peer-reviewed journals and conferences, and via training for healthcare professionals delivering OA management programmes. This evaluation is crucial to explaining the PARTNER study results, and will be used to determine the feasibility of rolling-out the intervention in an Australian healthcare context. TRIAL REGISTRATION NUMBER ACTRN12617001595303; Pre-results.",2020,PARTNER is a randomised controlled trial to evaluate a new model of service delivery (the PARTNER model) against 'usual care'.,"['patients with knee osteoarthritis (PARTNER) study', 'patients with knee osteoarthritis (PARTNER']",['telephone advice and support for OA management'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]",[],,0.060044,PARTNER is a randomised controlled trial to evaluate a new model of service delivery (the PARTNER model) against 'usual care'.,"[{'ForeName': 'Jocelyn L', 'Initials': 'JL', 'LastName': 'Bowden', 'Affiliation': 'Institute of Bone and Joint Research, Kolling Institute, The University of Sydney, St Leonards, New South Wales, Australia jocelyn.bowden@sydney.edu.au.'}, {'ForeName': 'Thorlene', 'Initials': 'T', 'LastName': 'Egerton', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rana S', 'Initials': 'RS', 'LastName': 'Hinman', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kim L', 'Initials': 'KL', 'LastName': 'Bennell', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Briggs', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Bunker', 'Affiliation': 'Medibank, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Kasza', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Simon D', 'Initials': 'SD', 'LastName': 'French', 'Affiliation': 'Department of Chiropractic, Faculty of Science and Engineering, Macquarie University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Pirotta', 'Affiliation': 'Department of General Practice, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Schofield', 'Affiliation': 'Centre for Economic Impacts of Genomic Medicine, Macquarie Business School, Macquarie University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Zwar', 'Affiliation': 'School of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Hunter', 'Affiliation': 'Institute of Bone and Joint Research, Kolling Institute, The University of Sydney, St Leonards, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-034526'] 268,31733490,Health-related quality of life after prophylactic cranial irradiation for stage III non-small cell lung cancer patients: Results from the NVALT-11/DLCRG-02 phase III study.,"BACKGROUND AND PURPOSE The NVALT-11/DLCRG-02 phase III trial (clinicaltrials.gov identifier: NCT01282437) showed that, after standard curative intent treatment, prophylactic cranial irradiation (PCI) decreased the incidence of symptomatic brain metastases (BM) in stage III non-small cell lung cancer (NSCLC) patients compared to observation. In this study we assessed the impact of PCI on health-related quality of life (HRQoL). In addition, an exploratory analysis was performed to assess the impact of neurocognitive symptoms and symptomatic BM on HRQoL. MATERIALS AND METHODS Stage III NSCLC patients were randomized between PCI and observation. HRQoL was measured using the EuroQol 5D (EQ-5D-3L), EORTC QLQ-C30 and QLQ-BN20 instruments at completion of standard curative intent treatment and 4 weeks, 3, 6, 12, 24 and 36 months thereafter. Generalized linear mixed effects (GLM) models were used to assess the impact of PCI compared to observation over time on three HRQoL metrics: the EORTC QLQ-C30 global health status and the EQ-5D-3L utility and visual analogue scale (EQ VAS) scores. RESULTS In total, 86 and 88 patients were included in the PCI and observation arm, with a median follow-up of 48.5 months (95% CI 39-54 months). Baseline mean HRQoL scores were comparable between the PCI and observation arm for the three HRQoL metrics. In the GLM models, none of the HRQoL metrics were clinically relevant or statistically significantly different between the PCI and the observation arm (p-values ranged between 0.641 and 0.914). CONCLUSION No statistically significant nor a clinically relevant impact of PCI on HRQoL was observed.",2020,Baseline mean HRQoL scores were comparable between the PCI and observation arm for the three HRQoL metrics.,"['stage III non-small cell lung cancer patients', 'Stage III NSCLC patients']","['standard curative intent treatment, prophylactic cranial irradiation (PCI', 'prophylactic cranial irradiation']","['EORTC QLQ-C30 global health status and the EQ-5D-3L utility and visual analogue scale (EQ VAS) scores', 'HRQoL', 'symptomatic brain metastases (BM', 'health-related quality of life (HRQoL', 'Baseline mean HRQoL scores', 'EuroQol 5D (EQ-5D-3L), EORTC QLQ-C30 and QLQ-BN20 instruments', 'Health-related quality of life']","[{'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0079172', 'cui_str': 'Cranial Irradiation'}]","[{'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain (disorder)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C4551823', 'cui_str': 'instruments'}]",,0.271153,Baseline mean HRQoL scores were comparable between the PCI and observation arm for the three HRQoL metrics.,"[{'ForeName': 'W J A', 'Initials': 'WJA', 'LastName': 'Witlox', 'Affiliation': 'Maastricht University Medical Centre(+), Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht, The Netherlands. Electronic address: willem.witlox@mumc.nl.'}, {'ForeName': 'B L T', 'Initials': 'BLT', 'LastName': 'Ramaekers', 'Affiliation': 'Maastricht University Medical Centre(+), Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht, The Netherlands.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Joore', 'Affiliation': 'Maastricht University Medical Centre(+), Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht, The Netherlands; Care and Public Health Research Institute (CAPHRI), Maastricht University, The Netherlands.'}, {'ForeName': 'A-M C', 'Initials': 'AC', 'LastName': 'Dingemans', 'Affiliation': 'Maastricht University Medical Center(+), Department of Pulmonology, GROW Research Institute, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Praag', 'Affiliation': 'Erasmus University Medical Center, Department of Radiation Oncology, Rotterdam, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Belderbos', 'Affiliation': 'Netherlands Cancer Institute (NKI), Department of Radiation Oncology, Amsterdam, The Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Tissing-Tan', 'Affiliation': 'Radiotherapy Institute Arnhem, Arnhem, The Netherlands.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Herder', 'Affiliation': 'Antonius Hospital Nieuwegein, Department of Pulmonology, The Netherlands.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Haitjema', 'Affiliation': 'Medical Center Alkmaar, Department of Pulmonology, The Netherlands.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Ubbels', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Radiation Oncology, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lagerwaard', 'Affiliation': 'Free University Medical Center, Department of Radiation Oncology, Amsterdam, The Netherlands.'}, {'ForeName': 'S Y', 'Initials': 'SY', 'LastName': 'El Sharouni', 'Affiliation': 'University Medical Center Utrecht, Department of Radiation Oncology, The Netherlands.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Stigt', 'Affiliation': 'Isala Hospital, Department of Pulmonology, Zwolle, The Netherlands.'}, {'ForeName': 'E F', 'Initials': 'EF', 'LastName': 'Smit', 'Affiliation': 'Netherlands Cancer Institute (NKI), Department of Pulmonology, Amsterdam, The Netherlands.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'van Tinteren', 'Affiliation': 'Netherlands Cancer Institute (NKI), Department of Biometrics, Amsterdam, The Netherlands.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'van der Noort', 'Affiliation': 'Netherlands Cancer Institute (NKI), Department of Biometrics, Amsterdam, The Netherlands.'}, {'ForeName': 'H J M', 'Initials': 'HJM', 'LastName': 'Groen', 'Affiliation': 'University of Groningen and University Medical Center Groningen, Department of Pulmonary Diseases, The Netherlands.'}, {'ForeName': 'D K M', 'Initials': 'DKM', 'LastName': 'De Ruysscher', 'Affiliation': 'Maastricht University Medical Centre(+), Department of Radiation Oncology (Maastro Clinic), GROW School of Oncology and Developmental Biology, The Netherlands; KU Leuven, Radiation Oncology, Belgium.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2019.10.016'] 269,30935324,"Effect of spinal manipulative therapy on mechanical pain sensitivity in patients with chronic nonspecific low back pain: a pilot randomized, controlled trial.","Objectives : The long-term goal of our study is to improve the understanding of the biological mechanisms associated with spinal manipulative therapy (SMT) in low back pain. Methods : This project involved a pilot randomized, blinded clinical trial (ClinicalTrials.gov registration number NCT03078114) of 3-week SMT in chronic nonspecific low back pain (CNSLBP) patients. We recruited 29 participants and randomly assigned them into either a SMT ( n = 14) or sham SMT ( n = 15) group. Pre- and postintervention, we quantified the effect of SMT on clinical outcomes (Numeric Pain Rating Scale and Oswestry Disability Index) and pressure pain threshold (PPT) at local (lumbar spine), regional (lower extremity), and remote (upper extremity) anatomical sites. Results : We observed a significant main effect for time signifying reduced hypersensitivity (increased PPT) at local ( p = .015) and regional ( p = .014) locations at 3 weeks. Furthermore, we found significant main effects of time indicating improvements in pain ( p < .001) and disability ( p = .02) from baseline among all participants regardless of intervention. However, no between-group differences were observed in PPT, clinical pain, or disability between the SMT and sham SMT groups over 3 weeks. Conclusions : After 3 weeks of SMT or sham SMT in CNSLBP patients, we found hypoalgesia at local and remote sites along with improved pain and low back-related disability. Level of Evidence : 1b.",2020,"However, no between-group differences were observed in PPT, clinical pain, or disability between the SMT and sham SMT groups over 3 weeks. ","['patients with chronic nonspecific low back pain', '29 participants', 'chronic nonspecific low back pain (CNSLBP) patients']","['SMT or sham SMT', 'SMT', 'spinal manipulative therapy (SMT', 'spinal manipulative therapy', 'sham SMT']","['pain', 'hypersensitivity', 'pain and low back-related disability', 'clinical outcomes (Numeric Pain Rating Scale and Oswestry Disability Index) and pressure pain threshold (PPT) at local (lumbar spine), regional (lower extremity), and remote (upper extremity) anatomical sites', 'disability', 'PPT, clinical pain, or disability', 'mechanical pain sensitivity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0949742', 'cui_str': 'Manipulation Therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3544362', 'cui_str': 'Hypersensitivity (SMQ)'}, {'cui': 'C2939142', 'cui_str': 'Lower back (surface region)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0234252', 'cui_str': 'Mechanical pain (finding)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}]",29.0,0.425737,"However, no between-group differences were observed in PPT, clinical pain, or disability between the SMT and sham SMT groups over 3 weeks. ","[{'ForeName': 'Bryan M', 'Initials': 'BM', 'LastName': 'Bond', 'Affiliation': 'Department of Physical Therapy, University of Saint Mary, Leavenworth, KS, USA.'}, {'ForeName': 'Chris D', 'Initials': 'CD', 'LastName': 'Kinslow', 'Affiliation': 'Department of Physical Therapy, University of Saint Mary, Leavenworth, KS, USA.'}, {'ForeName': 'Adam W', 'Initials': 'AW', 'LastName': 'Yoder', 'Affiliation': 'Department of Physical Therapy, University of Saint Mary, Leavenworth, KS, USA.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, USA.'}]",The Journal of manual & manipulative therapy,['10.1080/10669817.2019.1572986'] 270,32056311,"World Health Organization risk drinking level reductions are associated with improved functioning and are sustained among patients with mild, moderate and severe alcohol dependence in clinical trials in the United States and United Kingdom.","AIMS To examine whether World Health Organization (WHO) risk-level reductions in drinking were achievable, associated with improved functioning and maintained over time among patients at varying initial alcohol dependence severity levels. Design and setting Secondary data analysis of multi-site randomized clinical trials: the US Combined Pharmacotherapies and Behavioral Interventions for Alcohol Dependence (COMBINE) study and the UK Alcohol Treatment Trial (UKATT). PARTICIPANTS Individuals with alcohol dependence enrolled in COMBINE (n = 1383; 68.8% male) and seeking treatment for alcohol problems in UKATT (n = 742; 74.1% male). Interventions Naltrexone, acamprosate or placebo, and combined behavioral intervention or medication management in COMBINE. Social behavior network therapy or motivational enhancement therapy in UKATT. MEASUREMENTS WHO risk-level reductions were assessed via the calendar method. Alcohol dependence was measured by the Alcohol Dependence Scale, the Leeds Dependence Questionnaire and the Diagnostic and Statistical Manual of Mental Disorders. Measures of functioning included alcohol-related consequences (Drinker Inventory of Consequences and Alcohol Problems Questionnaire), mental health (Short Form Health Survey) and liver enzyme tests. FINDINGS One- and two-level reductions in WHO risk levels in the last month of treatment were maintained at the 1-year follow-up [adjusted odds ratio (OR), 95% confidence interval (CI) = one-level reduction in COMBINE: 3.51 (2.73, 4.29) and UKATT: 2.65 (2.32, 2.98)] and associated with fewer alcohol-related consequences [e.g. B, 95% CI = one-level reduction COMBINE: -26.22 (-30.62, -21.82)], better mental health [e.g. B, 95% CI = one-level reduction UKATT: 9.53 (7.36, 11.73)] and improvements in γ-glutamyltransferase [e.g. B, 95% CI = one-level reduction UKATT: -89.77 (-122.50, -57.04)] at the end of treatment, even among patients with severe alcohol dependence. Results were similar when abstainers were excluded. Conclusions Reductions in World Health Organization risk levels for alcohol consumption appear to be achievable, associated with better functioning and maintained over time in both the United States and the United Kingdom.",2020,"Results were similar when abstainers were excluded CONCLUSIONS: Reductions in World Health Organization risk levels for alcohol consumption appear to be achievable, associated with better functioning, and maintained over time in both the United States and the United Kingdom.",['Individuals with alcohol dependence enrolled in COMBINE (n=1383; 68.8% male) and seeking treatment for alcohol problems in UKATT (n=742; 74.1% male'],"['Social behavior network therapy or motivational enhancement therapy', 'Naltrexone, acamprosate, or placebo, and combined behavioral intervention or medication management']","['Alcohol dependence', 'functioning included alcohol-related consequences (Drinker Inventory of Consequences and Alcohol Problems Questionnaire), mental health (Short Form Health Survey), and liver enzyme tests', 'better mental health', 'Alcohol Dependence Scale, the Leeds Dependence Questionnaire, and the Diagnostic and Statistical Manual of Mental Disorders', 'WHO risk level reductions', 'WHO risk levels']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0549393', 'cui_str': 'Alcohol problem'}]","[{'cui': 'C0037397', 'cui_str': 'Social Behavior'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0284941', 'cui_str': 'acamprosate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0150270', 'cui_str': 'Medication administration case management'}]","[{'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0549393', 'cui_str': 'Alcohol problem'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0450984', 'cui_str': 'Alcohol dependence scale (assessment scale)'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.0432415,"Results were similar when abstainers were excluded CONCLUSIONS: Reductions in World Health Organization risk levels for alcohol consumption appear to be achievable, associated with better functioning, and maintained over time in both the United States and the United Kingdom.","[{'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Witkiewitz', 'Affiliation': 'Department of Psychology, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Heather', 'Affiliation': 'Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Falk', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.'}, {'ForeName': 'Raye Z', 'Initials': 'RZ', 'LastName': 'Litten', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.'}, {'ForeName': 'Deborah S', 'Initials': 'DS', 'LastName': 'Hasin', 'Affiliation': 'Department of Epidemiology, Columbia University, New York, NY, USA.'}, {'ForeName': 'Henry R', 'Initials': 'HR', 'LastName': 'Kranzler', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Karl F', 'Initials': 'KF', 'LastName': 'Mann', 'Affiliation': 'Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': ""O'Malley"", 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Raymond F', 'Initials': 'RF', 'LastName': 'Anton', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15011'] 271,31971899,Venous Vascular Closure System Versus Manual Compression Following Multiple Access Electrophysiology Procedures: The AMBULATE Trial.,"OBJECTIVES This study compared the efficacy and safety of the VASCADE MVP Venous Vascular Closure System (VVCS) device (Cardiva Medical, Santa Clara, California) to manual compression (MC) for closing multiple access sites after catheter-based electrophysiology procedures. BACKGROUND The VASCADE MVP VVCS is designed to provide earlier ambulatory hemostasis than MC after catheter-based procedures. METHODS The AMBULATE (A Randomized, Multi-center Trial to Compare Cardiva Mid-Bore [VASCADE MVP] VVCS to Manual Compression in Closure of Multiple Femoral Venous Access Sites in 6 - 12 Fr Sheath Sizes) trial was a multicenter, randomized trial of device closure versus MC in patients who underwent ablation. Outcomes included time to ambulation (TTA), total post-procedure time (TPPT), time to discharge eligibility (TTDe), time to hemostasis (TTH), 30-day major and minor complications, pain medication usage, and patient-reported outcomes. RESULTS A total of 204 patients at 13 sites were randomized to the device arm (n = 100; 369 access sites) or the MC arm (n = 104; 382 access sites). Baseline characteristics were similar between groups. Mean TTA, TPPT, TTDe, and TTH were substantially lower in the device arm (respective decreases of 54%, 54%, 52%, and 55%; all p < 0.0001). Opioid use was reduced by 58% (p = 0.001). There were no major access site complications. Incidence of minor complications was 1.0% for the device arm and 2.4% for the MC arm (p = 0.45). Patient satisfaction scores with duration of and comfort during bedrest were 63% and 36% higher in device group (both p < 0.0001). Satisfaction with bedrest pain was 25% higher (p = 0.001) for the device overall, and 40% higher (p = 0.002) for patients with a previous ablation. CONCLUSIONS Use of the closure device for multiple access ablation procedures resulted in significant reductions in TTA, TPPT, TTH, TTDe, and opioid use, with increased patient satisfaction and no increase in complications. (A Randomized, Multi-center Trial to Compare Cardiva Mid-Bore VVCS to Manual Compression in Closure of Multiple Femoral Venous Access Sites in 6 - 12 Fr Sheath Sizes [AMBULATE]; NCT03193021).",2020,"Satisfaction with bedrest pain was 25% higher (p = 0.001) for the device overall, and 40% higher (","['patients who underwent ablation', '204 patients at 13 sites', 'patients with a previous ablation']","['device closure versus MC', 'Venous Vascular Closure System Versus Manual Compression Following Multiple Access Electrophysiology Procedures', 'Cardiva Mid-Bore VVCS to Manual Compression', 'VASCADE MVP Venous Vascular Closure System (VVCS) device (Cardiva Medical, Santa Clara, California) to manual compression (MC', 'Cardiva Mid-Bore [VASCADE MVP] VVCS to Manual Compression']","['time to ambulation (TTA), total post-procedure time (TPPT), time to discharge eligibility (TTDe), time to hemostasis (TTH), 30-day major and minor complications, pain medication usage, and patient-reported outcomes', 'TTA, TPPT, TTH, TTDe, and opioid use, with increased patient satisfaction', 'Opioid use', 'Mean TTA, TPPT, TTDe, and TTH', 'Incidence of minor complications', 'Patient satisfaction scores with duration of and comfort during bedrest', 'Satisfaction with bedrest pain', 'complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}]","[{'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0013865', 'cui_str': 'Electrophysiology'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0006754', 'cui_str': 'California'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0945826', 'cui_str': 'Ambulation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C1627773', 'cui_str': 'Tissue texture abnormality'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score (assessment scale)'}, {'cui': 'C0449238', 'cui_str': 'Duration (attribute)'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",204.0,0.327771,"Satisfaction with bedrest pain was 25% higher (p = 0.001) for the device overall, and 40% higher (","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Natale', 'Affiliation': ""Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas, USA; Dell Medical School, University of Texas, Austin, Texas, USA; Case Western Reserve University, Cleveland, Ohio, USA; Interventional Electrophysiology, Scripps Clinic, San Diego, California, USA.""}, {'ForeName': 'Sanghamitra', 'Initials': 'S', 'LastName': 'Mohanty', 'Affiliation': ""Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas, USA; Dell Medical School, University of Texas, Austin, Texas, USA.""}, {'ForeName': 'P Y', 'Initials': 'PY', 'LastName': 'Liu', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Suneet', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': 'Valley Health System and the Snyder Center for Comprehensive Atrial Fibrillation, Ridgewood, New Jersey, USA.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Al-Ahmad', 'Affiliation': ""Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas, USA.""}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'De Lurgio', 'Affiliation': 'Emory Healthcare, Atlanta, Georgia, USA.'}, {'ForeName': 'Rodney', 'Initials': 'R', 'LastName': 'Horton', 'Affiliation': ""Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas, USA.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Spear', 'Affiliation': 'Advocate Christ Medical Center, Oak Lawn, Illinois, USA.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Bailey', 'Affiliation': ""Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas, USA.""}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Bunch', 'Affiliation': 'Intermountain Medical Center, Salt Lake City, Utah, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Musat', 'Affiliation': 'Valley Health System and the Snyder Center for Comprehensive Atrial Fibrillation, Ridgewood, New Jersey, USA.'}, {'ForeName': 'Padraig', 'Initials': 'P', 'LastName': ""O'Neill"", 'Affiliation': 'Mercy Medical Group, Sacramento, California, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Compton', 'Affiliation': 'Alaska Heart and Vascular Institute, Anchorage, Alaska, USA.'}, {'ForeName': 'Mintu P', 'Initials': 'MP', 'LastName': 'Turakhia', 'Affiliation': 'Stanford University, Stanford, California, USA; VA Palo Alto Health Care System, Palo Alto, California, USA. Electronic address: mintu@stanford.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Clinical electrophysiology,['10.1016/j.jacep.2019.08.013'] 272,32149586,Investigating the Effects of Error Management Training versus Error Avoidance Training on the Performance of Veterinary Students Learning to Tie Surgical Knots.,"Although errors can be a powerful impetus for learning, conventional pedagogy often emphasizes error-avoidance strategies that reward correct answers and disfavor mistakes. Error management training (EMT) takes an explicitly positive approach to errors, using them to create an active and self-directed learning environment. Using a surgical knot-tying model, we aimed to determine the efficacy of EMT among veterinary students with no prior surgical experience. We hypothesized that EMT would result in improved performance in unfamiliar scenarios (adaptive transfer) compared with an error-avoidance method. In this prospective double-blinded study, 42 students were equally divided between error avoidance training (EAT) and EMT groups. Performance in instrument- and hand-tied knots was evaluated for technique, time, number of attempts, and, when applicable, knot-leaking pressure. All participants demonstrated significant improvement between a pre-test and an analogous test 48 hours after training for all six outcomes (Wilcoxon matched pairs; two-tailed p s ≤ .013). An adaptive transfer test found no significant differences between EMT and EAT at 48 hours ( p s ≥ .053). All participants demonstrated a significant performance decline in six of eight outcomes at 7 weeks post-training ( p s ≤ .021). This decline was not significant for four of six EMT outcomes yet significant for five of six EAT outcomes. These data suggest that students trained in both EMT and EAT experience comparable gains in short-term performance, including adaptive transfer. Compared with EAT, EMT may help attenuate performance decline after a sustained period of quiescence. Educators may consider actively incorporating EMT into veterinary curricula.",2021,An adaptive transfer test found no significant differences between EMT and EAT at 48 hours ( p s ≥ .053).,"['veterinary students with no prior surgical experience', 'Veterinary Students Learning to Tie Surgical Knots', '42 students were equally divided between']","['Error Management Training versus Error Avoidance Training', 'EAT, EMT', 'EMT', 'surgical knot-tying model', 'Error management training (EMT', 'error avoidance training (EAT) and EMT']",[],"[{'cui': 'C0042614', 'cui_str': 'veterinary'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0453920', 'cui_str': 'Tie (physical object)'}, {'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0013963', 'cui_str': 'Emergency Medicine Technicians'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0453920', 'cui_str': 'Tie (physical object)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]",[],42.0,0.0373621,An adaptive transfer test found no significant differences between EMT and EAT at 48 hours ( p s ≥ .053).,"[{'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Meritet', 'Affiliation': ''}, {'ForeName': 'Katy L', 'Initials': 'KL', 'LastName': 'Townsend', 'Affiliation': ''}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Gorman', 'Affiliation': ''}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Chappell', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Kelly', 'Affiliation': ''}, {'ForeName': 'Duncan S', 'Initials': 'DS', 'LastName': 'Russell', 'Affiliation': ''}]",Journal of veterinary medical education,['10.3138/jvme.2019-0012'] 273,32151439,Behavior-Specific Cognitions Moderate Rural Women's Responsiveness to Web-Based Interventions for Weight Loss.,"OBJECTIVE To examine whether baseline behavior-specific cognitions moderated the effects of 2 Web-based interventions with enhanced features on weight loss success in rural women. DESIGN Secondary analysis of behavior-specific cognition data from a community-based, randomized controlled trial, as potential moderators of weight loss over 30 months. PARTICIPANTS Women, overweight or obese, from rural communities, aged 40-69 years (n = 200). INTERVENTIONS Theory-based Web interventions, with enhanced features of either peer-led Web discussion or professional e-mail counseling. MAIN OUTCOME MEASURES Benefits and barriers to healthy eating and activity; self-efficacy and interpersonal support for healthy eating and activity using validated surveys; and weight. ANALYSIS Longitudinal multilevel models. RESULTS Women in the professional e-mail counseling group were more likely to lose weight if they perceived fewer barriers to and higher self-efficacy for healthy eating and activity. Greater weight loss in the peer-led discussion group was observed for women with lower self-efficacy and higher perceptions of barriers. Interpersonal support did not moderate the effects of the interventions. CONCLUSIONS AND IMPLICATIONS Although women in 2 different Web-enhanced interventions achieved similar weight loss, their baseline perceptions of behavior-specific cognitions moderated their relationship with the type of intervention and weight loss success. These findings, although exploratory, may assist in matching women to Web interventions that would best maximize weight loss success. Further research is needed.",2020,Greater weight loss in the peer-led discussion group was observed for women with lower self-efficacy and higher perceptions of barriers.,"['Women in the professional e-mail counseling group', 'rural women', 'Women, overweight or obese, from rural communities, aged 40-69 years (n\u202f=\u202f200']","['Theory-based Web interventions, with enhanced features of either peer-led Web discussion or professional e-mail counseling']","['weight loss', 'weight loss success', 'Greater weight loss', 'Benefits and barriers to healthy eating and activity; self-efficacy and interpersonal support for healthy eating and activity using validated surveys; and weight']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",,0.0736969,Greater weight loss in the peer-led discussion group was observed for women with lower self-efficacy and higher perceptions of barriers.,"[{'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Kupzyk', 'Affiliation': 'College of Nursing, University of Nebraska Medical Center, Omaha, NE. Electronic address: kevin.kupzyk@unmc.edu.'}, {'ForeName': 'Bunny', 'Initials': 'B', 'LastName': 'Pozehl', 'Affiliation': 'College of Nursing, University of Nebraska Medical Center, Omaha, NE.'}, {'ForeName': 'Carol H', 'Initials': 'CH', 'LastName': 'Pullen', 'Affiliation': 'College of Nursing, University of Nebraska Medical Center, Omaha, NE.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Hageman', 'Affiliation': 'Physical Therapy Education, College of Allied Health Professions, University of Nebraska Medical Center, Omaha, NE.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2020.02.003'] 274,31147244,Optimizing Outcomes of Treatment-Resistant Depression in Older Adults (OPTIMUM): Study Design and Treatment Characteristics of the First 396 Participants Randomized.,"OBJECTIVE Evidence from clinical trials comparing effectiveness and safety of pharmacological strategies in older adults unresponsive to first-line antidepressants is limited. The study, Optimizing Outcomes of Treatment-Resistant Depression in Older Adults (OPTIMUM), tests three hypotheses concerning pharmacotherapy strategies for treatment-resistant late-life depression: 1) augmentation strategies will provide greater improvement than switching monotherapies; 2) augmentation strategies will have lower tolerability and more safety concerns than switching monotherapies; and 3) age will moderate the effectiveness and safety differences between treatment strategies. The authors describe the methodology, processes for stakeholder engagement, challenges, and lessons learned in the early phases of OPTIMUM. METHODS This pragmatic randomized clinical trial located in five North American regions will enroll 1,500 participants aged 60 years and older unresponsive to two or more antidepressant trials. The authors evaluate two strategies (medication augmentation versus switch) using four medications (aripiprazole, bupropion, lithium, and nortriptyline) via a stepwise, prespecified protocol. Primary outcomes include: 1) symptom remission (Montgomery Asberg Depression scale ≤10); 2) psychological well-being, comprising positive affect, general life satisfaction, and purpose; and 3) safety (rates of serious adverse events and prevalence of falls and fall-related injuries). RESULTS To date, 396 participants have been randomized. The authors report on four challenges: 1) engagement and recruitment; 2) increasing polypharmacy in older adults, resulting in potentially hazardous scenarios; 3) reporting adverse events and procedure standardization across sites; and 4) dissemination of results. CONCLUSION Solutions to these challenges, including early inclusion of stake holders, will inform future pragmatic studies in older adults with depression.",2019,"The study, Optimizing Outcomes of Treatment-Resistant Depression in Older Adults (OPTIMUM), tests three hypotheses concerning pharmacotherapy strategies for treatment-resistant late-life depression: 1) augmentation strategies will provide greater improvement than switching monotherapies; 2) augmentation strategies will have lower tolerability and more safety concerns than switching monotherapies; and 3) age will moderate the effectiveness and safety differences between treatment strategies.","['396 Participants Randomized', '396 participants have been randomized', 'five North American regions will enroll 1,500 participants aged 60 years and older unresponsive to two or more antidepressant trials', 'older adults unresponsive to first-line antidepressants', 'older adults with depression', 'older adults, resulting in potentially hazardous scenarios; 3) reporting adverse events and procedure standardization across sites; and 4) dissemination of results', 'Older Adults (OPTIMUM']","['strategies (medication augmentation versus switch) using four medications (aripiprazole, bupropion, lithium, and nortriptyline']","[' 1) symptom remission (Montgomery Asberg Depression scale ≤10); 2) psychological well-being, comprising positive affect, general life satisfaction, and purpose; and 3) safety (rates of serious adverse events and prevalence of falls and fall-related injuries']","[{'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237284', 'cui_str': 'Unresponsive'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0038136', 'cui_str': 'Standardization'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C3540800', 'cui_str': 'Lithium'}, {'cui': 'C0028420', 'cui_str': 'Nortriptyline'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]",1500.0,0.155316,"The study, Optimizing Outcomes of Treatment-Resistant Depression in Older Adults (OPTIMUM), tests three hypotheses concerning pharmacotherapy strategies for treatment-resistant late-life depression: 1) augmentation strategies will provide greater improvement than switching monotherapies; 2) augmentation strategies will have lower tolerability and more safety concerns than switching monotherapies; and 3) age will moderate the effectiveness and safety differences between treatment strategies.","[{'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Cristancho', 'Affiliation': 'Department of Psychiatry (PC, EL, EJL), Healthy Mind Lab, School of Medicine, Washington University in St. Louis, St. Louis. Electronic address: cristanchopimiento.l@psychiatry.wustl.edu.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Lenard', 'Affiliation': 'Department of Psychiatry (PC, EL, EJL), Healthy Mind Lab, School of Medicine, Washington University in St. Louis, St. Louis.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': 'Department of Psychiatry (PC, EL, EJL), Healthy Mind Lab, School of Medicine, Washington University in St. Louis, St. Louis.'}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Miller', 'Affiliation': 'the Division of Biostatistics (JPM), School of Medicine, Washington University in St. Louis, St. Louis.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Brown', 'Affiliation': 'the Department of Geriatric Psychiatry (PJB, SPR, CMG), Program on Healthy Aging and Late Life Brain Disorders, New York State Psychiatric Institute, Columbia University Medical Center, New York.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Roose', 'Affiliation': 'the Department of Geriatric Psychiatry (PJB, SPR, CMG), Program on Healthy Aging and Late Life Brain Disorders, New York State Psychiatric Institute, Columbia University Medical Center, New York.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Montes-Garcia', 'Affiliation': 'the Department of Geriatric Psychiatry (PJB, SPR, CMG), Program on Healthy Aging and Late Life Brain Disorders, New York State Psychiatric Institute, Columbia University Medical Center, New York.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'the Centre for Addiction and Mental Health and Department of Psychiatry (DMB, BHM), University of Toronto, Toronto.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'the Centre for Addiction and Mental Health and Department of Psychiatry (DMB, BHM), University of Toronto, Toronto.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Lavretsky', 'Affiliation': 'the Semel Institute for Neuroscience and Human Behavior (HL), University of California, Los Angeles.'}, {'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Rollman', 'Affiliation': 'the Department of Medicine and Center for Behavioral Health and Smart Technology (BLR), University of Pittsburgh School of Medicine, Pittsburgh.'}, {'ForeName': 'Charles F', 'Initials': 'CF', 'LastName': 'Reynolds', 'Affiliation': 'the Department of Psychiatry (CFR, JFK), University of Pittsburgh School of Medicine, Pittsburgh.'}, {'ForeName': 'Jordan F', 'Initials': 'JF', 'LastName': 'Karp', 'Affiliation': 'the Department of Psychiatry (CFR, JFK), University of Pittsburgh School of Medicine, Pittsburgh.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2019.04.005'] 275,31944474,Predictive factors for differential changes in grief symptoms following group bereavement intervention for Chinese widowed older adults.,"This study aimed to delineate changes in the patterns of prolonged grief severity in widowed adults following group bereavement interventions and to identify the predictive factors impacting these patterns. We performed a secondary analysis of data from a randomized trial of 125 Chinese widowed older adults who participated in either LOGBI or DPGBI. Self-ratings of prolonged grief symptoms via Inventory of Complicated Grief (ICG) were subjected to latent class growth analysis to identify subgroups according to symptomatic changes among baseline, post-treatment, and 8-week follow-up. Multinomial regression analysis examined whether participant classification could be predicted by demographics, loss-related characteristics, and the relationship with the deceased and baseline symptom severity. In the results, intervention sample comprised 96 completers with an attendance greater than 60%. A three-class categorization yielded the best model fit for changes in prolonged grief severity for both randomized and intervention samples: improved class (41.6% in the randomized sample, 42.8% in the intervention sample), partial responded class (48.1%/45.5%), and relapse class (10.3%/11.8%). Older widowed adults experiencing a high level of grief at baseline and bereavement following chronic illness had an elevated risk of symptomatic relapse after the completion of intervention. These findings indicated that Chinese widowed adults experienced different changing patterns of prolonged grief severity following group bereavement interventions. Practically, widowed adults with a higher risk of symptomatic relapse might need more intensive or longer term intervention or follow-up support.",2020,These findings indicated that Chinese widowed adults experienced different changing patterns of prolonged grief severity following group bereavement interventions.,"['125 Chinese widowed older adults who participated in either Loss-oriented or Dual Process group bereavement interventions', 'Chinese widowed older adults', '96 completers with an attendance greater than 60']",[],"['relapse class', 'symptomatic relapse', 'prolonged grief severity']","[{'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0206275', 'cui_str': 'Widowhood'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1879338', 'cui_str': 'Bereavement due to life event (finding)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]",[],"[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0018235', 'cui_str': 'Grief'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",,0.0835216,These findings indicated that Chinese widowed adults experienced different changing patterns of prolonged grief severity following group bereavement interventions.,"[{'ForeName': 'Daiming', 'Initials': 'D', 'LastName': 'Xiu', 'Affiliation': 'Department of Social Work and Social Administration, The University of Hong Kong, Pok Fu Lam, Hong Kong.'}, {'ForeName': 'Amy Y M', 'Initials': 'AYM', 'LastName': 'Chow', 'Affiliation': 'Department of Social Work and Social Administration, The University of Hong Kong, Pok Fu Lam, Hong Kong.'}, {'ForeName': 'Suqin', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': 'Department of Sociology, Law School, Shenzhen University, Shenzhen, China.'}]",Clinical psychology & psychotherapy,['10.1002/cpp.2425'] 276,32151214,A Randomized Controlled Trial of Video Psychoeducation for Electroconvulsive Therapy in the United States.,"OBJECTIVE Electroconvulsive therapy (ECT) is a highly effective psychiatric treatment that remains largely underutilized. Patient psychoeducation about ECT may improve uptake of this treatment. METHODS This randomized controlled trial compared two forms of psychoeducation about ECT: video psychoeducation and an informational brochure. In 2019, a national sample of 556 U.S. adults who screened positive for depression were recruited and randomly assigned to receive one of these educational interventions online. Participant perceptions, knowledge, and willingness to receive ECT were assessed before and after psychoeducation. RESULTS Both the video psychoeducation and brochure groups showed significantly more positive perceptions and knowledge about ECT following the intervention, with no significant differences between groups. The proportion of participants who reported being willing to receive ECT increased significantly after receipt of psychoeducation (from 31% to 63% in the video psychoeducation group and from 29% to 56% in the brochure group). Female gender, severity of depression, and comorbid mental and substance use disorders were associated with positive changes in ECT perceptions and increased willingness to receive ECT. CONCLUSIONS These findings suggest brief psychoeducation for ECT is needed and may improve acceptance of this robust treatment.",2020,"Both the video psychoeducation and brochure groups showed significantly more positive perceptions and knowledge about ECT following the intervention, with no significant differences between groups.","['In 2019, a national sample of 556 U.S. adults who screened positive for depression']","['ECT', 'educational interventions online', 'Electroconvulsive therapy (ECT', 'psychoeducation about ECT: video psychoeducation and an informational brochure', 'Video Psychoeducation']","['positive perceptions and knowledge about ECT', 'Participant perceptions, knowledge, and willingness to receive ECT']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4517811', 'cui_str': 'Five hundred and fifty-six'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}]",556.0,0.292575,"Both the video psychoeducation and brochure groups showed significantly more positive perceptions and knowledge about ECT following the intervention, with no significant differences between groups.","[{'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Tsai', 'Affiliation': 'National Center on Homelessness Among Veterans, U.S. Department of Veterans Affairs (VA), and the VA Connecticut Healthcare System, West Haven, Connecticut (Tsai, Rosenheck); Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut (Tsai, Rosenheck, Wilkinson); Department of Psychology, University of Hartford, West Hartford, Connecticut (Huang).'}, {'ForeName': 'Minda', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'National Center on Homelessness Among Veterans, U.S. Department of Veterans Affairs (VA), and the VA Connecticut Healthcare System, West Haven, Connecticut (Tsai, Rosenheck); Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut (Tsai, Rosenheck, Wilkinson); Department of Psychology, University of Hartford, West Hartford, Connecticut (Huang).'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Rosenheck', 'Affiliation': 'National Center on Homelessness Among Veterans, U.S. Department of Veterans Affairs (VA), and the VA Connecticut Healthcare System, West Haven, Connecticut (Tsai, Rosenheck); Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut (Tsai, Rosenheck, Wilkinson); Department of Psychology, University of Hartford, West Hartford, Connecticut (Huang).'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Wilkinson', 'Affiliation': 'National Center on Homelessness Among Veterans, U.S. Department of Veterans Affairs (VA), and the VA Connecticut Healthcare System, West Haven, Connecticut (Tsai, Rosenheck); Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut (Tsai, Rosenheck, Wilkinson); Department of Psychology, University of Hartford, West Hartford, Connecticut (Huang).'}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.201900448'] 277,31084635,Dynamic interpersonal therapy for moderate to severe depression: a pilot randomized controlled and feasibility trial.,"BACKGROUND Improving Access to Psychological Therapies (IAPT) services treat most patients in England who present to primary care with major depression. Psychodynamic psychotherapy is one of the psychotherapies offered. Dynamic Interpersonal Therapy (DIT) is a psychodynamic and mentalization-based treatment for depression. 16 sessions are delivered over approximately 5 months. Neither DIT's effectiveness relative to low-intensity treatment (LIT), nor the feasibility of randomizing patients to psychodynamic or cognitive-behavioural treatments (CBT) in an IAPT setting has been demonstrated. METHODS 147 patients were randomized in a 3:2:1 ratio to DIT (n = 73), LIT (control intervention; n = 54) or CBT (n = 20) in four IAPT treatment services in a combined superiority and feasibility design. Patients meeting criteria for major depressive disorder were assessed at baseline, mid-treatment (3 months) and post-treatment (6 months) using the Hamilton Rating Scale for Depression (HRSD-17), Beck Depression Inventory-II (BDI-II) and other self-rated questionnaire measures. Patients receiving DIT were also followed up 6 months post-completion. RESULTS The DIT arm showed significantly lower HRSD-17 scores at the 6-month primary end-point compared with LIT (d = 0.70). Significantly more DIT patients (51%) showed clinically significant change on the HRSD-17 compared with LIT (9%). The DIT and CBT arms showed equivalence on most outcomes. Results were similar with the BDI-II. DIT showed benefit across a range of secondary outcomes. CONCLUSIONS DIT delivered in a primary care setting is superior to LIT and can be appropriately compared with CBT in future RCTs.",2020,The DIT arm showed significantly lower HRSD-17 scores at the 6-month primary end-point compared with LIT (d = 0.70).,"['147 patients', 'moderate to severe depression', 'patients in England who present to primary care with major depression']","['IAPT treatment services', 'Dynamic interpersonal therapy', 'Psychodynamic psychotherapy', 'Dynamic Interpersonal Therapy (DIT', 'Psychological Therapies (IAPT) services', 'LIT (control intervention; n = 54) or CBT']","['HRSD-17', 'Hamilton Rating Scale for Depression (HRSD-17), Beck Depression Inventory-II (BDI-II) and other self-rated questionnaire measures', 'HRSD-17 scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C1261382', 'cui_str': 'Psychotherapy, Psychodynamic'}, {'cui': 'C0841584', 'cui_str': 'Psychological therapies (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression (assessment scale)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",147.0,0.0555702,The DIT arm showed significantly lower HRSD-17 scores at the 6-month primary end-point compared with LIT (d = 0.70).,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fonagy', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Lemma', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Target', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': ""O'Keeffe"", 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Constantinou', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Ventura Wurman', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Luyten', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Allison', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Roth', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Cape', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Pilling', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}]",Psychological medicine,['10.1017/S0033291719000928'] 278,31365800,Transfusion Volume for Children with Severe Anemia in Africa.,"BACKGROUND Severe anemia (hemoglobin level, <6 g per deciliter) is a leading cause of hospital admission and death in children in sub-Saharan Africa. The World Health Organization recommends transfusion of 20 ml of whole-blood equivalent per kilogram of body weight for anemia, regardless of hemoglobin level. METHODS In this factorial, open-label trial, we randomly assigned Ugandan and Malawian children 2 months to 12 years of age with a hemoglobin level of less than 6 g per deciliter and severity features (e.g., respiratory distress or reduced consciousness) to receive immediate blood transfusion with 20 ml per kilogram or 30 ml per kilogram. Three other randomized analyses investigated immediate as compared with no immediate transfusion, the administration of postdischarge micronutrients, and postdischarge prophylaxis with trimethoprim-sulfamethoxazole. The primary outcome was 28-day mortality. RESULTS A total of 3196 eligible children (median age, 37 months; 2050 [64.1%] with malaria) were assigned to receive a transfusion of 30 ml per kilogram (1598 children) or 20 ml per kilogram (1598 children) and were followed for 180 days. A total of 1592 children (99.6%) in the higher-volume group and 1596 (99.9%) in the lower-volume group started transfusion (median, 1.2 hours after randomization). The mean (±SD) volume of total blood transfused per child was 475±385 ml and 353±348 ml, respectively; 197 children (12.3%) and 300 children (18.8%) in the respective groups received additional transfusions. Overall, 55 children (3.4%) in the higher-volume group and 72 (4.5%) in the lower-volume group died before 28 days (hazard ratio, 0.76; 95% confidence interval [CI], 0.54 to 1.08; P = 0.12 by log-rank test). This finding masked significant heterogeneity in 28-day mortality according to the presence or absence of fever (>37.5°C) at screening (P=0.001 after Sidak correction). Among the 1943 children (60.8%) without fever, mortality was lower with a transfusion volume of 30 ml per kilogram than with a volume of 20 ml per kilogram (hazard ratio, 0.43; 95% CI, 0.27 to 0.69). Among the 1253 children (39.2%) with fever, mortality was higher with 30 ml per kilogram than with 20 ml per kilogram (hazard ratio, 1.91; 95% CI, 1.04 to 3.49). There was no evidence of differences between the randomized groups in readmissions, serious adverse events, or hemoglobin recovery at 180 days. CONCLUSIONS Overall mortality did not differ between the two transfusion strategies. (Funded by the Medical Research Council and Department for International Development, United Kingdom; TRACT Current Controlled Trials number, ISRCTN84086586.).",2019,"There was no evidence of differences between the randomized groups in readmissions, serious adverse events, or hemoglobin recovery at 180 days. ","['Children with Severe Anemia in Africa', 'children 2 months to 12 years of age with a hemoglobin level of less than 6 g per deciliter and severity features (e.g., respiratory distress or reduced consciousness) to receive', '1592 children (99.6%) in the higher-volume group and 1596 (99.9%) in the lower-volume group', '3196 eligible children (median age, 37 months; 2050 [64.1%] with malaria']","['immediate blood transfusion with 20 ml per kilogram or 30 ml per kilogram', 'Ugandan and Malawian', 'trimethoprim-sulfamethoxazole']","['Transfusion Volume', 'started transfusion', 'mean (±SD) volume of total blood transfused per child', 'fever, mortality', 'Overall mortality', 'readmissions, serious adverse events, or hemoglobin recovery', '28-day mortality']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0439241', 'cui_str': 'dL'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress (finding)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517914', 'cui_str': '99.9 (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0241520', 'cui_str': 'Ugandans (ethnic group)'}, {'cui': 'C0041044', 'cui_str': 'Sulfamethoxazole / Trimethoprim'}]","[{'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",1592.0,0.484471,"There was no evidence of differences between the randomized groups in readmissions, serious adverse events, or hemoglobin recovery at 180 days. ","[{'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Maitland', 'Affiliation': ""From the Department of Medicine (K.M., T.N.W.) and Nutrition Research Section (G.F.), Imperial College London, and the Medical Research Council Clinical Trials Unit at University College London (E.C.G., D.M.G., A.S.W.), London, the School of Medicine, Dentistry, and Biomedical Science, Queen's University, Belfast (N.K.), the Liverpool School of Tropical Medicine and Hygiene, Liverpool (I.B.), the Department of Pediatrics, University Hospital of Wales, Cardiff (J.A.E.), and the Centre for Health Economics, University of York, York (P.S.G.) - all in the United Kingdom; Busitema University Faculty of Health Sciences, Mbale Campus, Mbale Regional Referral Hospital (P.O.-O., J.N., C.N.), and the Mbale Blood Transfusion Services (B.W.), Mbale, the Department of Pediatrics, Makerere University and Mulago Hospital (S.K., R.O.O., J.K.), and the Uganda Blood Transfusion Services, National Blood Transfusion Services (D.K.B.), Kampala, and Soroti Regional Referral Hospital, Soroti (F.A., C.E., M.N.) - all in Uganda; the Kenya Medical Research Institute-Wellcome Trust Research Program, Kilifi (K.M., A.M., S.U., T.N.W.); and the College of Medicine and the Malawi-Liverpool-Wellcome Trust Clinical Research Program (G.C., M.M., N.K.) and the Malawi Blood Transfusion Services (B.M.) - all in Blantyre, Malawi.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Olupot-Olupot', 'Affiliation': ""From the Department of Medicine (K.M., T.N.W.) and Nutrition Research Section (G.F.), Imperial College London, and the Medical Research Council Clinical Trials Unit at University College London (E.C.G., D.M.G., A.S.W.), London, the School of Medicine, Dentistry, and Biomedical Science, Queen's University, Belfast (N.K.), the Liverpool School of Tropical Medicine and Hygiene, Liverpool (I.B.), the Department of Pediatrics, University Hospital of Wales, Cardiff (J.A.E.), and the Centre for Health Economics, University of York, York (P.S.G.) - all in the United Kingdom; Busitema University Faculty of Health Sciences, Mbale Campus, Mbale Regional Referral Hospital (P.O.-O., J.N., C.N.), and the Mbale Blood Transfusion Services (B.W.), Mbale, the Department of Pediatrics, Makerere University and Mulago Hospital (S.K., R.O.O., J.K.), and the Uganda Blood Transfusion Services, National Blood Transfusion Services (D.K.B.), Kampala, and Soroti Regional Referral Hospital, Soroti (F.A., C.E., M.N.) - all in Uganda; the Kenya Medical Research Institute-Wellcome Trust Research Program, Kilifi (K.M., A.M., S.U., T.N.W.); and the College of Medicine and the Malawi-Liverpool-Wellcome Trust Clinical Research Program (G.C., M.M., N.K.) and the Malawi Blood Transfusion Services (B.M.) - all in Blantyre, Malawi.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kiguli', 'Affiliation': ""From the Department of Medicine (K.M., T.N.W.) and Nutrition Research Section (G.F.), Imperial College London, and the Medical Research Council Clinical Trials Unit at University College London (E.C.G., D.M.G., A.S.W.), London, the School of Medicine, Dentistry, and Biomedical Science, Queen's University, Belfast (N.K.), the Liverpool School of Tropical Medicine and Hygiene, Liverpool (I.B.), the Department of Pediatrics, University Hospital of Wales, Cardiff (J.A.E.), and the Centre for Health Economics, University of York, York (P.S.G.) - all in the United Kingdom; Busitema University Faculty of Health Sciences, Mbale Campus, Mbale Regional Referral Hospital (P.O.-O., J.N., C.N.), and the Mbale Blood Transfusion Services (B.W.), Mbale, the Department of Pediatrics, Makerere University and Mulago Hospital (S.K., R.O.O., J.K.), and the Uganda Blood Transfusion Services, National Blood Transfusion Services (D.K.B.), Kampala, and Soroti Regional Referral Hospital, Soroti (F.A., C.E., M.N.) - all in Uganda; the Kenya Medical Research Institute-Wellcome Trust Research Program, Kilifi (K.M., A.M., S.U., T.N.W.); and the College of Medicine and the Malawi-Liverpool-Wellcome Trust Clinical Research Program (G.C., M.M., N.K.) and the Malawi Blood Transfusion Services (B.M.) - all in Blantyre, Malawi.""}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Chagaluka', 'Affiliation': ""From the Department of Medicine (K.M., T.N.W.) and Nutrition Research Section (G.F.), Imperial College London, and the Medical Research Council Clinical Trials Unit at University College London (E.C.G., D.M.G., A.S.W.), London, the School of Medicine, Dentistry, and Biomedical Science, Queen's University, Belfast (N.K.), the Liverpool School of Tropical Medicine and Hygiene, Liverpool (I.B.), the Department of Pediatrics, University Hospital of Wales, Cardiff (J.A.E.), and the Centre for Health Economics, University of York, York (P.S.G.) - all in the United Kingdom; Busitema University Faculty of Health Sciences, Mbale Campus, Mbale Regional Referral Hospital (P.O.-O., J.N., C.N.), and the Mbale Blood Transfusion Services (B.W.), Mbale, the Department of Pediatrics, Makerere University and Mulago Hospital (S.K., R.O.O., J.K.), and the Uganda Blood Transfusion Services, National Blood Transfusion Services (D.K.B.), Kampala, and Soroti Regional Referral Hospital, Soroti (F.A., C.E., M.N.) - all in Uganda; the Kenya Medical Research Institute-Wellcome Trust Research Program, Kilifi (K.M., A.M., S.U., T.N.W.); and the College of Medicine and the Malawi-Liverpool-Wellcome Trust Clinical Research Program (G.C., M.M., N.K.) and the Malawi Blood Transfusion Services (B.M.) - all in Blantyre, Malawi.""}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Alaroker', 'Affiliation': ""From the Department of Medicine (K.M., T.N.W.) and Nutrition Research Section (G.F.), Imperial College London, and the Medical Research Council Clinical Trials Unit at University College London (E.C.G., D.M.G., A.S.W.), London, the School of Medicine, Dentistry, and Biomedical Science, Queen's University, Belfast (N.K.), the Liverpool School of Tropical Medicine and Hygiene, Liverpool (I.B.), the Department of Pediatrics, University Hospital of Wales, Cardiff (J.A.E.), and the Centre for Health Economics, University of York, York (P.S.G.) - all in the United Kingdom; Busitema University Faculty of Health Sciences, Mbale Campus, Mbale Regional Referral Hospital (P.O.-O., J.N., C.N.), and the Mbale Blood Transfusion Services (B.W.), Mbale, the Department of Pediatrics, Makerere University and Mulago Hospital (S.K., R.O.O., J.K.), and the Uganda Blood Transfusion Services, National Blood Transfusion Services (D.K.B.), Kampala, and Soroti Regional Referral Hospital, Soroti (F.A., C.E., M.N.) - all in Uganda; the Kenya Medical Research Institute-Wellcome Trust Research Program, Kilifi (K.M., A.M., S.U., T.N.W.); and the College of Medicine and the Malawi-Liverpool-Wellcome Trust Clinical Research Program (G.C., M.M., N.K.) and the Malawi Blood Transfusion Services (B.M.) - all in Blantyre, Malawi.""}, {'ForeName': 'Robert O', 'Initials': 'RO', 'LastName': 'Opoka', 'Affiliation': ""From the Department of Medicine (K.M., T.N.W.) and Nutrition Research Section (G.F.), Imperial College London, and the Medical Research Council Clinical Trials Unit at University College London (E.C.G., D.M.G., A.S.W.), London, the School of Medicine, Dentistry, and Biomedical Science, Queen's University, Belfast (N.K.), the Liverpool School of Tropical Medicine and Hygiene, Liverpool (I.B.), the Department of Pediatrics, University Hospital of Wales, Cardiff (J.A.E.), and the Centre for Health Economics, University of York, York (P.S.G.) - all in the United Kingdom; Busitema University Faculty of Health Sciences, Mbale Campus, Mbale Regional Referral Hospital (P.O.-O., J.N., C.N.), and the Mbale Blood Transfusion Services (B.W.), Mbale, the Department of Pediatrics, Makerere University and Mulago Hospital (S.K., R.O.O., J.K.), and the Uganda Blood Transfusion Services, National Blood Transfusion Services (D.K.B.), Kampala, and Soroti Regional Referral Hospital, Soroti (F.A., C.E., M.N.) - all in Uganda; the Kenya Medical Research Institute-Wellcome Trust Research Program, Kilifi (K.M., A.M., S.U., T.N.W.); and the College of Medicine and the Malawi-Liverpool-Wellcome Trust Clinical Research Program (G.C., M.M., N.K.) and the Malawi Blood Transfusion Services (B.M.) - all in Blantyre, Malawi.""}, {'ForeName': 'Ayub', 'Initials': 'A', 'LastName': 'Mpoya', 'Affiliation': ""From the Department of Medicine (K.M., T.N.W.) and Nutrition Research Section (G.F.), Imperial College London, and the Medical Research Council Clinical Trials Unit at University College London (E.C.G., D.M.G., A.S.W.), London, the School of Medicine, Dentistry, and Biomedical Science, Queen's University, Belfast (N.K.), the Liverpool School of Tropical Medicine and Hygiene, Liverpool (I.B.), the Department of Pediatrics, University Hospital of Wales, Cardiff (J.A.E.), and the Centre for Health Economics, University of York, York (P.S.G.) - all in the United Kingdom; Busitema University Faculty of Health Sciences, Mbale Campus, Mbale Regional Referral Hospital (P.O.-O., J.N., C.N.), and the Mbale Blood Transfusion Services (B.W.), Mbale, the Department of Pediatrics, Makerere University and Mulago Hospital (S.K., R.O.O., J.K.), and the Uganda Blood Transfusion Services, National Blood Transfusion Services (D.K.B.), Kampala, and Soroti Regional Referral Hospital, Soroti (F.A., C.E., M.N.) - all in Uganda; the Kenya Medical Research Institute-Wellcome Trust Research Program, Kilifi (K.M., A.M., S.U., T.N.W.); and the College of Medicine and the Malawi-Liverpool-Wellcome Trust Clinical Research Program (G.C., M.M., N.K.) and the Malawi Blood Transfusion Services (B.M.) - all in Blantyre, Malawi.""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Engoru', 'Affiliation': ""From the Department of Medicine (K.M., T.N.W.) and Nutrition Research Section (G.F.), Imperial College London, and the Medical Research Council Clinical Trials Unit at University College London (E.C.G., D.M.G., A.S.W.), London, the School of Medicine, Dentistry, and Biomedical Science, Queen's University, Belfast (N.K.), the Liverpool School of Tropical Medicine and Hygiene, Liverpool (I.B.), the Department of Pediatrics, University Hospital of Wales, Cardiff (J.A.E.), and the Centre for Health Economics, University of York, York (P.S.G.) - all in the United Kingdom; Busitema University Faculty of Health Sciences, Mbale Campus, Mbale Regional Referral Hospital (P.O.-O., J.N., C.N.), and the Mbale Blood Transfusion Services (B.W.), Mbale, the Department of Pediatrics, Makerere University and Mulago Hospital (S.K., R.O.O., J.K.), and the Uganda Blood Transfusion Services, National Blood Transfusion Services (D.K.B.), Kampala, and Soroti Regional Referral Hospital, Soroti (F.A., C.E., M.N.) - all in Uganda; the Kenya Medical Research Institute-Wellcome Trust Research Program, Kilifi (K.M., A.M., S.U., T.N.W.); and the College of Medicine and the Malawi-Liverpool-Wellcome Trust Clinical Research Program (G.C., M.M., N.K.) and the Malawi Blood Transfusion Services (B.M.) - all in Blantyre, Malawi.""}, {'ForeName': 'Julius', 'Initials': 'J', 'LastName': 'Nteziyaremye', 'Affiliation': ""From the Department of Medicine (K.M., T.N.W.) and Nutrition Research Section (G.F.), Imperial College London, and the Medical Research Council Clinical Trials Unit at University College London (E.C.G., D.M.G., A.S.W.), London, the School of Medicine, Dentistry, and Biomedical Science, Queen's University, Belfast (N.K.), the Liverpool School of Tropical Medicine and Hygiene, Liverpool (I.B.), the Department of Pediatrics, University Hospital of Wales, Cardiff (J.A.E.), and the Centre for Health Economics, University of York, York (P.S.G.) - all in the United Kingdom; Busitema University Faculty of Health Sciences, Mbale Campus, Mbale Regional Referral Hospital (P.O.-O., J.N., C.N.), and the Mbale Blood Transfusion Services (B.W.), Mbale, the Department of Pediatrics, Makerere University and Mulago Hospital (S.K., R.O.O., J.K.), and the Uganda Blood Transfusion Services, National Blood Transfusion Services (D.K.B.), Kampala, and Soroti Regional Referral Hospital, Soroti (F.A., C.E., M.N.) - all in Uganda; the Kenya Medical Research Institute-Wellcome Trust Research Program, Kilifi (K.M., A.M., S.U., T.N.W.); and the College of Medicine and the Malawi-Liverpool-Wellcome Trust Clinical Research Program (G.C., M.M., N.K.) and the Malawi Blood Transfusion Services (B.M.) - all in Blantyre, Malawi.""}, {'ForeName': 'Macpherson', 'Initials': 'M', 'LastName': 'Mallewa', 'Affiliation': ""From the Department of Medicine (K.M., T.N.W.) and Nutrition Research Section (G.F.), Imperial College London, and the Medical Research Council Clinical Trials Unit at University College London (E.C.G., D.M.G., A.S.W.), London, the School of Medicine, Dentistry, and Biomedical Science, Queen's University, Belfast (N.K.), the Liverpool School of Tropical Medicine and Hygiene, Liverpool (I.B.), the Department of Pediatrics, University Hospital of Wales, Cardiff (J.A.E.), and the Centre for Health Economics, University of York, York (P.S.G.) - all in the United Kingdom; Busitema University Faculty of Health Sciences, Mbale Campus, Mbale Regional Referral Hospital (P.O.-O., J.N., C.N.), and the Mbale Blood Transfusion Services (B.W.), Mbale, the Department of Pediatrics, Makerere University and Mulago Hospital (S.K., R.O.O., J.K.), and the Uganda Blood Transfusion Services, National Blood Transfusion Services (D.K.B.), Kampala, and Soroti Regional Referral Hospital, Soroti (F.A., C.E., M.N.) - all in Uganda; the Kenya Medical Research Institute-Wellcome Trust Research Program, Kilifi (K.M., A.M., S.U., T.N.W.); and the College of Medicine and the Malawi-Liverpool-Wellcome Trust Clinical Research Program (G.C., M.M., N.K.) and the Malawi Blood Transfusion Services (B.M.) - all in Blantyre, Malawi.""}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Kennedy', 'Affiliation': ""From the Department of Medicine (K.M., T.N.W.) and Nutrition Research Section (G.F.), Imperial College London, and the Medical Research Council Clinical Trials Unit at University College London (E.C.G., D.M.G., A.S.W.), London, the School of Medicine, Dentistry, and Biomedical Science, Queen's University, Belfast (N.K.), the Liverpool School of Tropical Medicine and Hygiene, Liverpool (I.B.), the Department of Pediatrics, University Hospital of Wales, Cardiff (J.A.E.), and the Centre for Health Economics, University of York, York (P.S.G.) - all in the United Kingdom; Busitema University Faculty of Health Sciences, Mbale Campus, Mbale Regional Referral Hospital (P.O.-O., J.N., C.N.), and the Mbale Blood Transfusion Services (B.W.), Mbale, the Department of Pediatrics, Makerere University and Mulago Hospital (S.K., R.O.O., J.K.), and the Uganda Blood Transfusion Services, National Blood Transfusion Services (D.K.B.), Kampala, and Soroti Regional Referral Hospital, Soroti (F.A., C.E., M.N.) - all in Uganda; the Kenya Medical Research Institute-Wellcome Trust Research Program, Kilifi (K.M., A.M., S.U., T.N.W.); and the College of Medicine and the Malawi-Liverpool-Wellcome Trust Clinical Research Program (G.C., M.M., N.K.) and the Malawi Blood Transfusion Services (B.M.) - all in Blantyre, Malawi.""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Nakuya', 'Affiliation': ""From the Department of Medicine (K.M., T.N.W.) and Nutrition Research Section (G.F.), Imperial College London, and the Medical Research Council Clinical Trials Unit at University College London (E.C.G., D.M.G., A.S.W.), London, the School of Medicine, Dentistry, and Biomedical Science, Queen's University, Belfast (N.K.), the Liverpool School of Tropical Medicine and Hygiene, Liverpool (I.B.), the Department of Pediatrics, University Hospital of Wales, Cardiff (J.A.E.), and the Centre for Health Economics, University of York, York (P.S.G.) - all in the United Kingdom; Busitema University Faculty of Health Sciences, Mbale Campus, Mbale Regional Referral Hospital (P.O.-O., J.N., C.N.), and the Mbale Blood Transfusion Services (B.W.), Mbale, the Department of Pediatrics, Makerere University and Mulago Hospital (S.K., R.O.O., J.K.), and the Uganda Blood Transfusion Services, National Blood Transfusion Services (D.K.B.), Kampala, and Soroti Regional Referral Hospital, Soroti (F.A., C.E., M.N.) - all in Uganda; the Kenya Medical Research Institute-Wellcome Trust Research Program, Kilifi (K.M., A.M., S.U., T.N.W.); and the College of Medicine and the Malawi-Liverpool-Wellcome Trust Clinical Research Program (G.C., M.M., N.K.) and the Malawi Blood Transfusion Services (B.M.) - all in Blantyre, Malawi.""}, {'ForeName': 'Cate', 'Initials': 'C', 'LastName': 'Namayanja', 'Affiliation': ""From the Department of Medicine (K.M., T.N.W.) and Nutrition Research Section (G.F.), Imperial College London, and the Medical Research Council Clinical Trials Unit at University College London (E.C.G., D.M.G., A.S.W.), London, the School of Medicine, Dentistry, and Biomedical Science, Queen's University, Belfast (N.K.), the Liverpool School of Tropical Medicine and Hygiene, Liverpool (I.B.), the Department of Pediatrics, University Hospital of Wales, Cardiff (J.A.E.), and the Centre for Health Economics, University of York, York (P.S.G.) - all in the United Kingdom; Busitema University Faculty of Health Sciences, Mbale Campus, Mbale Regional Referral Hospital (P.O.-O., J.N., C.N.), and the Mbale Blood Transfusion Services (B.W.), Mbale, the Department of Pediatrics, Makerere University and Mulago Hospital (S.K., R.O.O., J.K.), and the Uganda Blood Transfusion Services, National Blood Transfusion Services (D.K.B.), Kampala, and Soroti Regional Referral Hospital, Soroti (F.A., C.E., M.N.) - all in Uganda; the Kenya Medical Research Institute-Wellcome Trust Research Program, Kilifi (K.M., A.M., S.U., T.N.W.); and the College of Medicine and the Malawi-Liverpool-Wellcome Trust Clinical Research Program (G.C., M.M., N.K.) and the Malawi Blood Transfusion Services (B.M.) - all in Blantyre, Malawi.""}, {'ForeName': 'Julianna', 'Initials': 'J', 'LastName': 'Kayaga', 'Affiliation': ""From the Department of Medicine (K.M., T.N.W.) and Nutrition Research Section (G.F.), Imperial College London, and the Medical Research Council Clinical Trials Unit at University College London (E.C.G., D.M.G., A.S.W.), London, the School of Medicine, Dentistry, and Biomedical Science, Queen's University, Belfast (N.K.), the Liverpool School of Tropical Medicine and Hygiene, Liverpool (I.B.), the Department of Pediatrics, University Hospital of Wales, Cardiff (J.A.E.), and the Centre for Health Economics, University of York, York (P.S.G.) - all in the United Kingdom; Busitema University Faculty of Health Sciences, Mbale Campus, Mbale Regional Referral Hospital (P.O.-O., J.N., C.N.), and the Mbale Blood Transfusion Services (B.W.), Mbale, the Department of Pediatrics, Makerere University and Mulago Hospital (S.K., R.O.O., J.K.), and the Uganda Blood Transfusion Services, National Blood Transfusion Services (D.K.B.), Kampala, and Soroti Regional Referral Hospital, Soroti (F.A., C.E., M.N.) - all in Uganda; the Kenya Medical Research Institute-Wellcome Trust Research Program, Kilifi (K.M., A.M., S.U., T.N.W.); and the College of Medicine and the Malawi-Liverpool-Wellcome Trust Clinical Research Program (G.C., M.M., N.K.) and the Malawi Blood Transfusion Services (B.M.) - all in Blantyre, Malawi.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Uyoga', 'Affiliation': ""From the Department of Medicine (K.M., T.N.W.) and Nutrition Research Section (G.F.), Imperial College London, and the Medical Research Council Clinical Trials Unit at University College London (E.C.G., D.M.G., A.S.W.), London, the School of Medicine, Dentistry, and Biomedical Science, Queen's University, Belfast (N.K.), the Liverpool School of Tropical Medicine and Hygiene, Liverpool (I.B.), the Department of Pediatrics, University Hospital of Wales, Cardiff (J.A.E.), and the Centre for Health Economics, University of York, York (P.S.G.) - all in the United Kingdom; Busitema University Faculty of Health Sciences, Mbale Campus, Mbale Regional Referral Hospital (P.O.-O., J.N., C.N.), and the Mbale Blood Transfusion Services (B.W.), Mbale, the Department of Pediatrics, Makerere University and Mulago Hospital (S.K., R.O.O., J.K.), and the Uganda Blood Transfusion Services, National Blood Transfusion Services (D.K.B.), Kampala, and Soroti Regional Referral Hospital, Soroti (F.A., C.E., M.N.) - all in Uganda; the Kenya Medical Research Institute-Wellcome Trust Research Program, Kilifi (K.M., A.M., S.U., T.N.W.); and the College of Medicine and the Malawi-Liverpool-Wellcome Trust Clinical Research Program (G.C., M.M., N.K.) and the Malawi Blood Transfusion Services (B.M.) - all in Blantyre, Malawi.""}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Kyeyune Byabazaire', 'Affiliation': ""From the Department of Medicine (K.M., T.N.W.) and Nutrition Research Section (G.F.), Imperial College London, and the Medical Research Council Clinical Trials Unit at University College London (E.C.G., D.M.G., A.S.W.), London, the School of Medicine, Dentistry, and Biomedical Science, Queen's University, Belfast (N.K.), the Liverpool School of Tropical Medicine and Hygiene, Liverpool (I.B.), the Department of Pediatrics, University Hospital of Wales, Cardiff (J.A.E.), and the Centre for Health Economics, University of York, York (P.S.G.) - all in the United Kingdom; Busitema University Faculty of Health Sciences, Mbale Campus, Mbale Regional Referral Hospital (P.O.-O., J.N., C.N.), and the Mbale Blood Transfusion Services (B.W.), Mbale, the Department of Pediatrics, Makerere University and Mulago Hospital (S.K., R.O.O., J.K.), and the Uganda Blood Transfusion Services, National Blood Transfusion Services (D.K.B.), Kampala, and Soroti Regional Referral Hospital, Soroti (F.A., C.E., M.N.) - all in Uganda; the Kenya Medical Research Institute-Wellcome Trust Research Program, Kilifi (K.M., A.M., S.U., T.N.W.); and the College of Medicine and the Malawi-Liverpool-Wellcome Trust Clinical Research Program (G.C., M.M., N.K.) and the Malawi Blood Transfusion Services (B.M.) - all in Blantyre, Malawi.""}, {'ForeName': 'Bridon', 'Initials': 'B', 'LastName': ""M'baya"", 'Affiliation': ""From the Department of Medicine (K.M., T.N.W.) and Nutrition Research Section (G.F.), Imperial College London, and the Medical Research Council Clinical Trials Unit at University College London (E.C.G., D.M.G., A.S.W.), London, the School of Medicine, Dentistry, and Biomedical Science, Queen's University, Belfast (N.K.), the Liverpool School of Tropical Medicine and Hygiene, Liverpool (I.B.), the Department of Pediatrics, University Hospital of Wales, Cardiff (J.A.E.), and the Centre for Health Economics, University of York, York (P.S.G.) - all in the United Kingdom; Busitema University Faculty of Health Sciences, Mbale Campus, Mbale Regional Referral Hospital (P.O.-O., J.N., C.N.), and the Mbale Blood Transfusion Services (B.W.), Mbale, the Department of Pediatrics, Makerere University and Mulago Hospital (S.K., R.O.O., J.K.), and the Uganda Blood Transfusion Services, National Blood Transfusion Services (D.K.B.), Kampala, and Soroti Regional Referral Hospital, Soroti (F.A., C.E., M.N.) - all in Uganda; the Kenya Medical Research Institute-Wellcome Trust Research Program, Kilifi (K.M., A.M., S.U., T.N.W.); and the College of Medicine and the Malawi-Liverpool-Wellcome Trust Clinical Research Program (G.C., M.M., N.K.) and the Malawi Blood Transfusion Services (B.M.) - all in Blantyre, Malawi.""}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Wabwire', 'Affiliation': ""From the Department of Medicine (K.M., T.N.W.) and Nutrition Research Section (G.F.), Imperial College London, and the Medical Research Council Clinical Trials Unit at University College London (E.C.G., D.M.G., A.S.W.), London, the School of Medicine, Dentistry, and Biomedical Science, Queen's University, Belfast (N.K.), the Liverpool School of Tropical Medicine and Hygiene, Liverpool (I.B.), the Department of Pediatrics, University Hospital of Wales, Cardiff (J.A.E.), and the Centre for Health Economics, University of York, York (P.S.G.) - all in the United Kingdom; Busitema University Faculty of Health Sciences, Mbale Campus, Mbale Regional Referral Hospital (P.O.-O., J.N., C.N.), and the Mbale Blood Transfusion Services (B.W.), Mbale, the Department of Pediatrics, Makerere University and Mulago Hospital (S.K., R.O.O., J.K.), and the Uganda Blood Transfusion Services, National Blood Transfusion Services (D.K.B.), Kampala, and Soroti Regional Referral Hospital, Soroti (F.A., C.E., M.N.) - all in Uganda; the Kenya Medical Research Institute-Wellcome Trust Research Program, Kilifi (K.M., A.M., S.U., T.N.W.); and the College of Medicine and the Malawi-Liverpool-Wellcome Trust Clinical Research Program (G.C., M.M., N.K.) and the Malawi Blood Transfusion Services (B.M.) - all in Blantyre, Malawi.""}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Frost', 'Affiliation': ""From the Department of Medicine (K.M., T.N.W.) and Nutrition Research Section (G.F.), Imperial College London, and the Medical Research Council Clinical Trials Unit at University College London (E.C.G., D.M.G., A.S.W.), London, the School of Medicine, Dentistry, and Biomedical Science, Queen's University, Belfast (N.K.), the Liverpool School of Tropical Medicine and Hygiene, Liverpool (I.B.), the Department of Pediatrics, University Hospital of Wales, Cardiff (J.A.E.), and the Centre for Health Economics, University of York, York (P.S.G.) - all in the United Kingdom; Busitema University Faculty of Health Sciences, Mbale Campus, Mbale Regional Referral Hospital (P.O.-O., J.N., C.N.), and the Mbale Blood Transfusion Services (B.W.), Mbale, the Department of Pediatrics, Makerere University and Mulago Hospital (S.K., R.O.O., J.K.), and the Uganda Blood Transfusion Services, National Blood Transfusion Services (D.K.B.), Kampala, and Soroti Regional Referral Hospital, Soroti (F.A., C.E., M.N.) - all in Uganda; the Kenya Medical Research Institute-Wellcome Trust Research Program, Kilifi (K.M., A.M., S.U., T.N.W.); and the College of Medicine and the Malawi-Liverpool-Wellcome Trust Clinical Research Program (G.C., M.M., N.K.) and the Malawi Blood Transfusion Services (B.M.) - all in Blantyre, Malawi.""}, {'ForeName': 'Imelda', 'Initials': 'I', 'LastName': 'Bates', 'Affiliation': ""From the Department of Medicine (K.M., T.N.W.) and Nutrition Research Section (G.F.), Imperial College London, and the Medical Research Council Clinical Trials Unit at University College London (E.C.G., D.M.G., A.S.W.), London, the School of Medicine, Dentistry, and Biomedical Science, Queen's University, Belfast (N.K.), the Liverpool School of Tropical Medicine and Hygiene, Liverpool (I.B.), the Department of Pediatrics, University Hospital of Wales, Cardiff (J.A.E.), and the Centre for Health Economics, University of York, York (P.S.G.) - all in the United Kingdom; Busitema University Faculty of Health Sciences, Mbale Campus, Mbale Regional Referral Hospital (P.O.-O., J.N., C.N.), and the Mbale Blood Transfusion Services (B.W.), Mbale, the Department of Pediatrics, Makerere University and Mulago Hospital (S.K., R.O.O., J.K.), and the Uganda Blood Transfusion Services, National Blood Transfusion Services (D.K.B.), Kampala, and Soroti Regional Referral Hospital, Soroti (F.A., C.E., M.N.) - all in Uganda; the Kenya Medical Research Institute-Wellcome Trust Research Program, Kilifi (K.M., A.M., S.U., T.N.W.); and the College of Medicine and the Malawi-Liverpool-Wellcome Trust Clinical Research Program (G.C., M.M., N.K.) and the Malawi Blood Transfusion Services (B.M.) - all in Blantyre, Malawi.""}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Evans', 'Affiliation': ""From the Department of Medicine (K.M., T.N.W.) and Nutrition Research Section (G.F.), Imperial College London, and the Medical Research Council Clinical Trials Unit at University College London (E.C.G., D.M.G., A.S.W.), London, the School of Medicine, Dentistry, and Biomedical Science, Queen's University, Belfast (N.K.), the Liverpool School of Tropical Medicine and Hygiene, Liverpool (I.B.), the Department of Pediatrics, University Hospital of Wales, Cardiff (J.A.E.), and the Centre for Health Economics, University of York, York (P.S.G.) - all in the United Kingdom; Busitema University Faculty of Health Sciences, Mbale Campus, Mbale Regional Referral Hospital (P.O.-O., J.N., C.N.), and the Mbale Blood Transfusion Services (B.W.), Mbale, the Department of Pediatrics, Makerere University and Mulago Hospital (S.K., R.O.O., J.K.), and the Uganda Blood Transfusion Services, National Blood Transfusion Services (D.K.B.), Kampala, and Soroti Regional Referral Hospital, Soroti (F.A., C.E., M.N.) - all in Uganda; the Kenya Medical Research Institute-Wellcome Trust Research Program, Kilifi (K.M., A.M., S.U., T.N.W.); and the College of Medicine and the Malawi-Liverpool-Wellcome Trust Clinical Research Program (G.C., M.M., N.K.) and the Malawi Blood Transfusion Services (B.M.) - all in Blantyre, Malawi.""}, {'ForeName': 'Thomas N', 'Initials': 'TN', 'LastName': 'Williams', 'Affiliation': ""From the Department of Medicine (K.M., T.N.W.) and Nutrition Research Section (G.F.), Imperial College London, and the Medical Research Council Clinical Trials Unit at University College London (E.C.G., D.M.G., A.S.W.), London, the School of Medicine, Dentistry, and Biomedical Science, Queen's University, Belfast (N.K.), the Liverpool School of Tropical Medicine and Hygiene, Liverpool (I.B.), the Department of Pediatrics, University Hospital of Wales, Cardiff (J.A.E.), and the Centre for Health Economics, University of York, York (P.S.G.) - all in the United Kingdom; Busitema University Faculty of Health Sciences, Mbale Campus, Mbale Regional Referral Hospital (P.O.-O., J.N., C.N.), and the Mbale Blood Transfusion Services (B.W.), Mbale, the Department of Pediatrics, Makerere University and Mulago Hospital (S.K., R.O.O., J.K.), and the Uganda Blood Transfusion Services, National Blood Transfusion Services (D.K.B.), Kampala, and Soroti Regional Referral Hospital, Soroti (F.A., C.E., M.N.) - all in Uganda; the Kenya Medical Research Institute-Wellcome Trust Research Program, Kilifi (K.M., A.M., S.U., T.N.W.); and the College of Medicine and the Malawi-Liverpool-Wellcome Trust Clinical Research Program (G.C., M.M., N.K.) and the Malawi Blood Transfusion Services (B.M.) - all in Blantyre, Malawi.""}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Saramago Goncalves', 'Affiliation': ""From the Department of Medicine (K.M., T.N.W.) and Nutrition Research Section (G.F.), Imperial College London, and the Medical Research Council Clinical Trials Unit at University College London (E.C.G., D.M.G., A.S.W.), London, the School of Medicine, Dentistry, and Biomedical Science, Queen's University, Belfast (N.K.), the Liverpool School of Tropical Medicine and Hygiene, Liverpool (I.B.), the Department of Pediatrics, University Hospital of Wales, Cardiff (J.A.E.), and the Centre for Health Economics, University of York, York (P.S.G.) - all in the United Kingdom; Busitema University Faculty of Health Sciences, Mbale Campus, Mbale Regional Referral Hospital (P.O.-O., J.N., C.N.), and the Mbale Blood Transfusion Services (B.W.), Mbale, the Department of Pediatrics, Makerere University and Mulago Hospital (S.K., R.O.O., J.K.), and the Uganda Blood Transfusion Services, National Blood Transfusion Services (D.K.B.), Kampala, and Soroti Regional Referral Hospital, Soroti (F.A., C.E., M.N.) - all in Uganda; the Kenya Medical Research Institute-Wellcome Trust Research Program, Kilifi (K.M., A.M., S.U., T.N.W.); and the College of Medicine and the Malawi-Liverpool-Wellcome Trust Clinical Research Program (G.C., M.M., N.K.) and the Malawi Blood Transfusion Services (B.M.) - all in Blantyre, Malawi.""}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'George', 'Affiliation': ""From the Department of Medicine (K.M., T.N.W.) and Nutrition Research Section (G.F.), Imperial College London, and the Medical Research Council Clinical Trials Unit at University College London (E.C.G., D.M.G., A.S.W.), London, the School of Medicine, Dentistry, and Biomedical Science, Queen's University, Belfast (N.K.), the Liverpool School of Tropical Medicine and Hygiene, Liverpool (I.B.), the Department of Pediatrics, University Hospital of Wales, Cardiff (J.A.E.), and the Centre for Health Economics, University of York, York (P.S.G.) - all in the United Kingdom; Busitema University Faculty of Health Sciences, Mbale Campus, Mbale Regional Referral Hospital (P.O.-O., J.N., C.N.), and the Mbale Blood Transfusion Services (B.W.), Mbale, the Department of Pediatrics, Makerere University and Mulago Hospital (S.K., R.O.O., J.K.), and the Uganda Blood Transfusion Services, National Blood Transfusion Services (D.K.B.), Kampala, and Soroti Regional Referral Hospital, Soroti (F.A., C.E., M.N.) - all in Uganda; the Kenya Medical Research Institute-Wellcome Trust Research Program, Kilifi (K.M., A.M., S.U., T.N.W.); and the College of Medicine and the Malawi-Liverpool-Wellcome Trust Clinical Research Program (G.C., M.M., N.K.) and the Malawi Blood Transfusion Services (B.M.) - all in Blantyre, Malawi.""}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Gibb', 'Affiliation': ""From the Department of Medicine (K.M., T.N.W.) and Nutrition Research Section (G.F.), Imperial College London, and the Medical Research Council Clinical Trials Unit at University College London (E.C.G., D.M.G., A.S.W.), London, the School of Medicine, Dentistry, and Biomedical Science, Queen's University, Belfast (N.K.), the Liverpool School of Tropical Medicine and Hygiene, Liverpool (I.B.), the Department of Pediatrics, University Hospital of Wales, Cardiff (J.A.E.), and the Centre for Health Economics, University of York, York (P.S.G.) - all in the United Kingdom; Busitema University Faculty of Health Sciences, Mbale Campus, Mbale Regional Referral Hospital (P.O.-O., J.N., C.N.), and the Mbale Blood Transfusion Services (B.W.), Mbale, the Department of Pediatrics, Makerere University and Mulago Hospital (S.K., R.O.O., J.K.), and the Uganda Blood Transfusion Services, National Blood Transfusion Services (D.K.B.), Kampala, and Soroti Regional Referral Hospital, Soroti (F.A., C.E., M.N.) - all in Uganda; the Kenya Medical Research Institute-Wellcome Trust Research Program, Kilifi (K.M., A.M., S.U., T.N.W.); and the College of Medicine and the Malawi-Liverpool-Wellcome Trust Clinical Research Program (G.C., M.M., N.K.) and the Malawi Blood Transfusion Services (B.M.) - all in Blantyre, Malawi.""}, {'ForeName': 'A Sarah', 'Initials': 'AS', 'LastName': 'Walker', 'Affiliation': ""From the Department of Medicine (K.M., T.N.W.) and Nutrition Research Section (G.F.), Imperial College London, and the Medical Research Council Clinical Trials Unit at University College London (E.C.G., D.M.G., A.S.W.), London, the School of Medicine, Dentistry, and Biomedical Science, Queen's University, Belfast (N.K.), the Liverpool School of Tropical Medicine and Hygiene, Liverpool (I.B.), the Department of Pediatrics, University Hospital of Wales, Cardiff (J.A.E.), and the Centre for Health Economics, University of York, York (P.S.G.) - all in the United Kingdom; Busitema University Faculty of Health Sciences, Mbale Campus, Mbale Regional Referral Hospital (P.O.-O., J.N., C.N.), and the Mbale Blood Transfusion Services (B.W.), Mbale, the Department of Pediatrics, Makerere University and Mulago Hospital (S.K., R.O.O., J.K.), and the Uganda Blood Transfusion Services, National Blood Transfusion Services (D.K.B.), Kampala, and Soroti Regional Referral Hospital, Soroti (F.A., C.E., M.N.) - all in Uganda; the Kenya Medical Research Institute-Wellcome Trust Research Program, Kilifi (K.M., A.M., S.U., T.N.W.); and the College of Medicine and the Malawi-Liverpool-Wellcome Trust Clinical Research Program (G.C., M.M., N.K.) and the Malawi Blood Transfusion Services (B.M.) - all in Blantyre, Malawi.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1900100'] 279,31985558,Effects of Art and Reminiscence Therapy on Agitated Behaviors Among Older Adults With Dementia.,"BACKGROUND Cognitive degeneration and agitated behavior symptoms of dementia in older adults are the main causes of disability and inability and increase the cost of medical care. Agitated behavior symptoms of dementia are the main causes of early institutionalization and make caregivers exhausted. PURPOSE The aim of this study was to examine the effects of art therapy and reminiscence therapy on the alleviation of agitated behaviors in older adults with dementia. METHODS An experimental research design with two experimental groups and one comparison group was conducted to examine the effects for each group on agitated behaviors. Participants were recruited from two dementia care centers in central and northern Taiwan. The study included 54 older individuals who met the sampling criteria and completed the data collection process. The participants were randomly allocated into the art therapy group (n = 24), the reminiscence therapy group (n = 22), and the comparison group (n = 8). The intervention consisted of 50-minute sessions conducted weekly for 12 weeks. Regular activities were continued in the comparison group. The structured questionnaires were completed, and observations of agitated behaviors were collected before the intervention and at 1 and 6 weeks after the intervention. RESULTS Significant differences were found in agitated behavior symptoms at the three time points in the art therapy group, whereas reminiscence therapy was found to have had a clear and immediate effect on decreasing agitated behavior. The generalized estimating equation exchange model test revealed a significant and sustained, postintervention effect of art therapy on agitated behavior. In contrast, no significant and sustained effect on agitated behavior was observed in the reminiscence therapy group. CONCLUSIONS The findings of this study support that art therapy may have a positive effect on dementia-associated agitated behaviors in institutionalized older adults. Reminiscence therapy activities conducted weekly for 50 minutes each session did not reach statistically significant implications. It is suggested that future studies consider conducting art and reminiscence therapies for a 16-week duration with two weekly sessions to evaluate the effectiveness of the therapy. The duration of follow-up should be extended as well in future studies.",2020,"The generalized estimating equation exchange model test revealed a significant and sustained, postintervention effect of art therapy on agitated behavior.","['institutionalized older adults', 'older adults with dementia', 'Participants were recruited from two dementia care centers in central and northern Taiwan', 'older adults', 'Older Adults With Dementia', '54 older individuals who met the sampling criteria and completed the data collection process']","['art therapy and reminiscence therapy', 'Art and Reminiscence Therapy', 'reminiscence therapy']","['Regular activities', 'agitated behavior', 'Agitated Behaviors', 'agitated behavior symptoms']","[{'cui': 'C0562359', 'cui_str': 'Institutionalized (finding)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}]","[{'cui': 'C0003827', 'cui_str': 'Art Therapy'}, {'cui': 'C0150321', 'cui_str': 'Rt - reminiscence therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",54.0,0.051653,"The generalized estimating equation exchange model test revealed a significant and sustained, postintervention effect of art therapy on agitated behavior.","[{'ForeName': 'Chiu-Yueh', 'Initials': 'CY', 'LastName': 'Hsiao', 'Affiliation': 'PhD, RN, Assistant Professor, College of Nursing, Hungkuang University, Taiwan, ROC.'}, {'ForeName': 'Shu-Li', 'Initials': 'SL', 'LastName': 'Chen', 'Affiliation': 'PhD, RN, CNE, NEA-BC, Professor, College of Nursing, Hungkuang University, Taiwan, ROC.'}, {'ForeName': 'Yu-Shuang', 'Initials': 'YS', 'LastName': 'Hsiao', 'Affiliation': 'PhD, RN, Adjunct Assistant Professor, Department of Nursing, National Taichung University of Science and Technology, and Adjunct Assistant Professor, Department of Gerontic Technology and Service Management, Nan Kai University of Technology, Taiwan, ROC.'}, {'ForeName': 'Hsiu-Yun', 'Initials': 'HY', 'LastName': 'Huang', 'Affiliation': 'MSN, RN, Supervisor, Department of Nursing, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Taiwan, ROC.'}, {'ForeName': 'Shu-Hui', 'Initials': 'SH', 'LastName': 'Yeh', 'Affiliation': 'PhD, ANP, RN, Professor, Institute of Long-Term Care, Mackay Medical College, Taiwan, ROC.'}]",The journal of nursing research : JNR,['10.1097/jnr.0000000000000373'] 280,32151537,Screening Mammogram Results in the Digital Age: Video Messaging - A Pilot Study.,"OBJECTIVE To assess patients' preferences for receiving screening mammogram results via a video message from their radiologist versus the traditional methods. METHODS The Institutional Review Board approved this prospective study which enrolled participants from March to May 2019, after written consent was obtained. Two breast radiologists prerecorded video results for normal and abnormal screening mammograms. Women 40 years and older presenting for a screening mammogram who had a prior mammogram and no clinical symptoms were invited to participate in the study. After their mammogram, participants were assigned to obtain results via video message or by traditional methods such as a mailed letter or phone call. Participants then completed an online survey asking questions regarding the method of results delivery. RESULTS Around 80/94 participants ranging in age from 40 to 76 years old responded (85% response rate), of which 73% (58/80) preferred a video message from the radiologist for their mammogram results (p = 0.029). When analyzed by age, the video results were most liked by patients 40-60 years old. When analyzed by education level, participants with a Master's or Bachelor's degree liked receiving their results by video. DISCUSSION Our study suggests that patients in the screening mammography setting may prefer a video message from their radiologist to the traditional methods of delivery, including mailed letters and receiving results from their primary care provider. Video results could potentially be utilized in the delivery of other results of standardized medical tests as a method to offer more timely delivery of results and a personal connection.",2021,"RESULTS Around 80/94 participants ranging in age from 40 to 76 years old responded (85% response rate), of which 73% (58/80) preferred a video message from the radiologist for their mammogram results (p = 0.029).","[""participants with a Master's or Bachelor's degree liked receiving their results by video"", 'Women 40 years and older presenting for a screening mammogram who had a prior mammogram and no clinical symptoms were invited to participate in the study', 'enrolled participants from March to May 2019, after written consent was obtained']",['video message or by traditional methods such as a mailed letter or phone call'],[],"[{'cui': 'C0444649', 'cui_str': 'Master (qualifier value)'}, {'cui': 'C0337600', 'cui_str': 'Bachelor (finding)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1096774', 'cui_str': 'Letter'}]",[],,0.0457439,"RESULTS Around 80/94 participants ranging in age from 40 to 76 years old responded (85% response rate), of which 73% (58/80) preferred a video message from the radiologist for their mammogram results (p = 0.029).","[{'ForeName': 'Rifat A', 'Initials': 'RA', 'LastName': 'Wahab', 'Affiliation': 'Department of Radiology, University of Cincinnati Medical Center, 234 Goodman Street ML 0772, Cincinnati, OH 45219-0772. Electronic address: wahabrt@ucmail.uc.edu.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Brown', 'Affiliation': 'Department of Radiology, University of Cincinnati Medical Center, 234 Goodman Street ML 0772, Cincinnati, OH 45219-0772.'}, {'ForeName': 'Su-Ju', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, University of Cincinnati Medical Center, 234 Goodman Street ML 0772, Cincinnati, OH 45219-0772.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': ""Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Sobel', 'Affiliation': 'Department of Radiology, University of Cincinnati Medical Center, 234 Goodman Street ML 0772, Cincinnati, OH 45219-0772.'}, {'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Mahoney', 'Affiliation': 'Benjamin Felson Endowed Chair & Professor of Radiology, University of Cincinnati Medical Center, Department of Radiology, Cincinnati, Ohio.'}]",Academic radiology,['10.1016/j.acra.2020.01.011'] 281,30808022,Randomized trial of intermittent intraputamenal glial cell line-derived neurotrophic factor in Parkinson's disease.,"We investigated the effects of glial cell line-derived neurotrophic factor (GDNF) in Parkinson's disease, using intermittent intraputamenal convection-enhanced delivery via a skull-mounted transcutaneous port as a novel administration paradigm to potentially afford putamen-wide therapeutic delivery. This was a single-centre, randomized, double-blind, placebo-controlled trial. Patients were 35-75 years old, had motor symptoms for 5 or more years, and presented with moderate disease severity in the OFF state [Hoehn and Yahr stage 2-3 and Unified Parkinson's Disease Rating Scale motor score (part III) (UPDRS-III) between 25 and 45] and motor fluctuations. Drug delivery devices were implanted and putamenal volume coverage was required to exceed a predefined threshold at a test infusion prior to randomization. Six pilot stage patients (randomization 2:1) and 35 primary stage patients (randomization 1:1) received bilateral intraputamenal infusions of GDNF (120 µg per putamen) or placebo every 4 weeks for 40 weeks. Efficacy analyses were based on the intention-to-treat principle and included all patients randomized. The primary outcome was the percentage change from baseline to Week 40 in the OFF state (UPDRS-III). The primary analysis was limited to primary stage patients, while further analyses included all patients from both study stages. The mean OFF state UPDRS motor score decreased by 17.3 ± 17.6% in the active group and 11.8 ± 15.8% in the placebo group (least squares mean difference: -4.9%, 95% CI: -16.9, 7.1, P = 0.41). Secondary endpoints did not show significant differences between the groups either. A post hoc analysis found nine (43%) patients in the active group but no placebo patients with a large clinically important motor improvement (≥10 points) in the OFF state (P = 0.0008). 18F-DOPA PET imaging demonstrated a significantly increased uptake throughout the putamen only in the active group, ranging from 25% (left anterior putamen; P = 0.0009) to 100% (both posterior putamina; P < 0.0001). GDNF appeared to be well tolerated and safe, and no drug-related serious adverse events were reported. The study did not meet its primary endpoint. 18F-DOPA imaging, however, suggested that intermittent convection-enhanced delivery of GDNF produced a putamen-wide tissue engagement effect, overcoming prior delivery limitations. Potential reasons for not proving clinical benefit at 40 weeks are discussed.",2019,"18F-DOPA PET imaging demonstrated a significantly increased uptake throughout the putamen only in the active group, ranging from 25% (left anterior putamen; P = 0.0009) to 100% (both posterior putamina; P < 0.0001).","[""Patients were 35-75 years old, had motor symptoms for 5 or more years, and presented with moderate disease severity in the OFF state [Hoehn and Yahr stage 2-3 and Unified Parkinson's Disease Rating Scale motor score (part III) (UPDRS-III) between 25 and 45] and motor fluctuations"", ""Parkinson's disease"", 'Six pilot stage patients (randomization 2:1) and 35 primary stage patients (randomization 1:1) received']","['placebo', 'GDNF', 'intermittent intraputamenal glial cell line-derived neurotrophic factor', 'glial cell line-derived neurotrophic factor (GDNF', 'bilateral intraputamenal infusions of GDNF']","['tolerated and safe', 'percentage change from baseline to Week 40 in the OFF state (UPDRS-III', 'mean OFF state UPDRS motor score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0165079', 'cui_str': 'IS 35'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms (finding)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1868976', 'cui_str': 'Motor fluctuations'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0207072', 'cui_str': 'Glial Cell Line-Derived Neurotrophic Factor'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C1579754', 'cui_str': 'Glial Cell Line-Derived Neurotrophic Factors'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.4514,"18F-DOPA PET imaging demonstrated a significantly increased uptake throughout the putamen only in the active group, ranging from 25% (left anterior putamen; P = 0.0009) to 100% (both posterior putamina; P < 0.0001).","[{'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Whone', 'Affiliation': 'Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Luz', 'Affiliation': 'MedGenesis Therapeutix Inc., Victoria, BC, Canada.'}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Boca', 'Affiliation': 'Neurological and Musculoskeletal Sciences Division, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Woolley', 'Affiliation': 'Renishaw plc, New Mills, Wotton-under-Edge, Gloucestershire, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Mooney', 'Affiliation': 'Neurological and Musculoskeletal Sciences Division, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Dharia', 'Affiliation': 'Neurological and Musculoskeletal Sciences Division, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Broadfoot', 'Affiliation': 'Neurological and Musculoskeletal Sciences Division, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cronin', 'Affiliation': 'Neurological and Musculoskeletal Sciences Division, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schroers', 'Affiliation': 'Neurological and Musculoskeletal Sciences Division, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Neil U', 'Initials': 'NU', 'LastName': 'Barua', 'Affiliation': 'Neurological and Musculoskeletal Sciences Division, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Longpre', 'Affiliation': 'MedGenesis Therapeutix Inc., Victoria, BC, Canada.'}, {'ForeName': 'C Lynn', 'Initials': 'CL', 'LastName': 'Barclay', 'Affiliation': 'MedGenesis Therapeutix Inc., Victoria, BC, Canada.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Boiko', 'Affiliation': 'MedGenesis Therapeutix Inc., Victoria, BC, Canada.'}, {'ForeName': 'Greg A', 'Initials': 'GA', 'LastName': 'Johnson', 'Affiliation': 'MedGenesis Therapeutix Inc., Victoria, BC, Canada.'}, {'ForeName': 'H Christian', 'Initials': 'HC', 'LastName': 'Fibiger', 'Affiliation': 'MedGenesis Therapeutix Inc., Victoria, BC, Canada.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Harrison', 'Affiliation': 'Renishaw plc, New Mills, Wotton-under-Edge, Gloucestershire, UK.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Lewis', 'Affiliation': 'Renishaw plc, New Mills, Wotton-under-Edge, Gloucestershire, UK.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Pritchard', 'Affiliation': 'Renishaw plc, New Mills, Wotton-under-Edge, Gloucestershire, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Howell', 'Affiliation': 'Renishaw plc, New Mills, Wotton-under-Edge, Gloucestershire, UK.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Irving', 'Affiliation': 'Renishaw plc, New Mills, Wotton-under-Edge, Gloucestershire, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Johnson', 'Affiliation': 'Renishaw plc, New Mills, Wotton-under-Edge, Gloucestershire, UK.'}, {'ForeName': 'Suk', 'Initials': 'S', 'LastName': 'Kinch', 'Affiliation': 'Renishaw plc, New Mills, Wotton-under-Edge, Gloucestershire, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Marshall', 'Affiliation': 'The Wales Research and Diagnostic Positron Emission Tomography Imaging Centre (PETIC), Cardiff University, Cardiff, UK.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Lawrence', 'Affiliation': 'School of Psychology, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Blinder', 'Affiliation': 'Department of Physics and Astronomy, The University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Sossi', 'Affiliation': 'Department of Physics and Astronomy, The University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'A Jon', 'Initials': 'AJ', 'LastName': 'Stoessl', 'Affiliation': 'Djavad Mowafaghian Centre for Brain Health, Faculty of Medicine, The University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Skinner', 'Affiliation': 'Renishaw plc, New Mills, Wotton-under-Edge, Gloucestershire, UK.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Mohr', 'Affiliation': 'MedGenesis Therapeutix Inc., Victoria, BC, Canada.'}, {'ForeName': 'Steven S', 'Initials': 'SS', 'LastName': 'Gill', 'Affiliation': 'Neurological and Musculoskeletal Sciences Division, North Bristol NHS Trust, Bristol, UK.'}]",Brain : a journal of neurology,['10.1093/brain/awz023'] 282,30458059,A pilot trial of RNS60 in amyotrophic lateral sclerosis.,"INTRODUCTION RNS60 is a novel immune-modulatory agent that has shown neuroprotective effects in amytrophic lateral sclerosis (ALS) preclinical models. RNS60 is administered by weekly intravenous infusion and daily nebulization. The objective of this pilot open-label trial was to test the feasibility, safety, and tolerability of long-term RNS60 administration in ALS patients. METHODS The planned treatment duration was 23 weeks and the primary outcomes were safety and tolerability. Secondary outcomes included PBR28 positron emission tomography (PET) imaging and plasma biomarkers of inflammation. RESULTS Sixteen participants with ALS received RNS60 and 13 (81%) completed 23 weeks of RNS60 treatment. There were no serious adverse events and no participants withdrew from the trial due to drug-related adverse events. There were no significant changes in the biomarkers. DISCUSSION Long-term RNS60 administration was safe and well-tolerated. A large, multicenter, phase II trial of RNS60 is currently enrolling participants to test the effects of RNS60 on ALS biomarkers and disease progression. Muscle Nerve 59:303-308, 2019.",2019,"INTRODUCTION RNS60 is a novel immune-modulatory agent that has shown neuroprotective effects in amytrophic lateral sclerosis (ALS) preclinical models.","['ALS patients', 'amyotrophic lateral sclerosis']",['RNS60'],"['PBR28 positron emission tomography (PET) imaging and plasma biomarkers of inflammation', 'ALS biomarkers and disease progression', 'safety and tolerability', 'feasibility, safety, and tolerability', 'serious adverse events', 'safe and well-tolerated']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002736', 'cui_str': 'ALS (Amyotrophic Lateral Sclerosis)'}]","[{'cui': 'C4705670', 'cui_str': 'RNS60'}]","[{'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",16.0,0.0264706,"INTRODUCTION RNS60 is a novel immune-modulatory agent that has shown neuroprotective effects in amytrophic lateral sclerosis (ALS) preclinical models.","[{'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Paganoni', 'Affiliation': 'Neurological Clinical Research Institute, Massachusetts General Hospital, 165 Cambridge Street, Suite 600, Boston, Massachusetts, 02114, USA.'}, {'ForeName': 'Mohamad J', 'Initials': 'MJ', 'LastName': 'Alshikho', 'Affiliation': 'Neurological Clinical Research Institute, Massachusetts General Hospital, 165 Cambridge Street, Suite 600, Boston, Massachusetts, 02114, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Luppino', 'Affiliation': 'Neurological Clinical Research Institute, Massachusetts General Hospital, 165 Cambridge Street, Suite 600, Boston, Massachusetts, 02114, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Chan', 'Affiliation': 'Massachusetts General Hospital Biostatistics Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Pothier', 'Affiliation': 'Neurological Clinical Research Institute, Massachusetts General Hospital, 165 Cambridge Street, Suite 600, Boston, Massachusetts, 02114, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schoenfeld', 'Affiliation': 'Massachusetts General Hospital Biostatistics Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Patricia L', 'Initials': 'PL', 'LastName': 'Andres', 'Affiliation': 'Neurological Clinical Research Institute, Massachusetts General Hospital, 165 Cambridge Street, Suite 600, Boston, Massachusetts, 02114, USA.'}, {'ForeName': 'Suma', 'Initials': 'S', 'LastName': 'Babu', 'Affiliation': 'Neurological Clinical Research Institute, Massachusetts General Hospital, 165 Cambridge Street, Suite 600, Boston, Massachusetts, 02114, USA.'}, {'ForeName': 'Nicole R', 'Initials': 'NR', 'LastName': 'Zürcher', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Marco L', 'Initials': 'ML', 'LastName': 'Loggia', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Barry', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Luotti', 'Affiliation': 'IRCCS Mario Negri Institute for Pharmacological Research, Milan, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Nardo', 'Affiliation': 'IRCCS Mario Negri Institute for Pharmacological Research, Milan, Italy.'}, {'ForeName': 'Maria Chiara', 'Initials': 'MC', 'LastName': 'Trolese', 'Affiliation': 'IRCCS Mario Negri Institute for Pharmacological Research, Milan, Italy.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Pantalone', 'Affiliation': 'IRCCS Mario Negri Institute for Pharmacological Research, Milan, Italy.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Bendotti', 'Affiliation': 'IRCCS Mario Negri Institute for Pharmacological Research, Milan, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Bonetto', 'Affiliation': 'IRCCS Mario Negri Institute for Pharmacological Research, Milan, Italy.'}, {'ForeName': 'Fabiola', 'Initials': 'F', 'LastName': 'De Marchi', 'Affiliation': 'Neurological Clinical Research Institute, Massachusetts General Hospital, 165 Cambridge Street, Suite 600, Boston, Massachusetts, 02114, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Rosen', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Hooker', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Merit', 'Initials': 'M', 'LastName': 'Cudkowicz', 'Affiliation': 'Neurological Clinical Research Institute, Massachusetts General Hospital, 165 Cambridge Street, Suite 600, Boston, Massachusetts, 02114, USA.'}, {'ForeName': 'Nazem', 'Initials': 'N', 'LastName': 'Atassi', 'Affiliation': 'Neurological Clinical Research Institute, Massachusetts General Hospital, 165 Cambridge Street, Suite 600, Boston, Massachusetts, 02114, USA.'}]",Muscle & nerve,['10.1002/mus.26385'] 283,29952696,Injury Risk Factors Integrated Into Self-Guided Real-Time Biofeedback Improves High-Risk Biomechanics.,"CONTEXT Existing anterior cruciate ligament (ACL) injury prevention programs have failed to reverse the high rate of ACL injuries in adolescent female athletes. OBJECTIVE This investigation attempts to overcome factors that limit efficacy with existing injury prevention programs through the use of a novel, objective, and real-time interactive visual feedback system designed to reduce the biomechanical risk factors associated with ACL injuries. DESIGN Cross-over study. SETTING Medical center laboratory. PARTICIPANTS A total of 20 females (age = 19.7 [1.34] y; height = 1.74 [0.09] m; weight = 72.16 [12.45] kg) participated in this study. METHODS Participants performed sets of 10 bodyweight squats in each of 8 training blocks (ie, 4 real-time and 4 control blocks) and 3 testing blocks for a total of 110 squats. Feedback conditions were blocked and counterbalanced with half of participants randomly assigned to receive the real-time feedback block first and half receiving the control (sham) feedback first. RESULTS Heat map analysis revealed that during interaction with the real-time feedback, squat performance measured in terms of key biomechanical parameters was improved compared with performance when participants squatted with the sham stimulus. CONCLUSIONS This study demonstrates that the interactive feedback system guided participants to significantly improve movement biomechanics during performance of a body weight squat, which is a fundamental exercise for a longer term ACL injury risk reduction intervention. A longer training and testing period is necessary to investigate the efficacy of this feedback approach to effect long-term adaptations in the biomechanical risk profile of athletes.",2019,"This study demonstrates that the interactive feedback system guided participants to significantly improve movement biomechanics during performance of a body weight squat, which is a fundamental exercise for a longer term ACL injury risk reduction intervention.","['Medical center laboratory', 'm; weight\u2009=\u200972.16 [12.45]\xa0kg) participated in this study', 'Participants performed sets of 10 bodyweight squats in each of 8 training blocks (ie,\xa04 real-time and 4 control blocks) and 3 testing blocks for a total of 110 squats', 'A total of 20 females (age\u2009=\u200919.7 [1.34', 'adolescent female athletes']","['interactive feedback system guided participants', 'real-time feedback block first and half receiving the control (sham) feedback first', 'Self-Guided Real-Time Biofeedback']","['real-time feedback, squat performance']","[{'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517501', 'cui_str': '1.34'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}]",110.0,0.0455351,"This study demonstrates that the interactive feedback system guided participants to significantly improve movement biomechanics during performance of a body weight squat, which is a fundamental exercise for a longer term ACL injury risk reduction intervention.","[{'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Bonnette', 'Affiliation': ''}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'DiCesare', 'Affiliation': ''}, {'ForeName': 'Adam W', 'Initials': 'AW', 'LastName': 'Kiefer', 'Affiliation': ''}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Riley', 'Affiliation': ''}, {'ForeName': 'Kim D', 'Initials': 'KD', 'LastName': 'Barber Foss', 'Affiliation': ''}, {'ForeName': 'Staci', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': ''}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Kitchen', 'Affiliation': ''}, {'ForeName': 'Jed A', 'Initials': 'JA', 'LastName': 'Diekfuss', 'Affiliation': ''}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Myer', 'Affiliation': ''}]",Journal of sport rehabilitation,['10.1123/jsr.2017-0391'] 284,31977104,Reaching out to big losers leads to sustained reductions in gambling over 1 year: a randomized controlled trial of brief motivational contact.,"BACKGROUND AND AIMS A previous randomized controlled trial demonstrated that telephone- and letter-based motivational interventions with high-expenditure gamblers had significant short-term positive effects on gambling and use of responsible gambling tools. This post-trial follow-up examined outcomes in gambling expenditure over 12 months. DESIGN Observational study following a three-arm randomized controlled trial. SETTING Customers of Norsk Tipping (NT) gambling platforms, Norway. PARTICIPANTS A total of 1003 statistical triplets from the top 0.5% of customers based upon annual expenditure, matched on sex, age and net losses. Mean age was 53.4 years; 19% were women, mean yearly loss for 2016 was 88 197 NoK. Interventions and comparator Feedback intervention by telephone, letter or a no-contact control condition. MEASUREMENTS Primary outcome measure was gambling theoretical loss, derived from the NT customer database. Secondary outcomes were responsible gambling customer actions and whether or not the participant was retained as an NT customer. FINDINGS Per-protocol analyses of triplets who received the telephone call or letter as randomly assigned (n = 596) showed a positive and sustained effect over 12 months: the telephone group showed a 30% reduction in theoretical loss (d = 0.44) and the letter group 13% (d = 0.18), both outperforming the control group with a 7% reduction (d = 0.11). The telephone condition was superior to both the letter and control conditions in per-protocol (P < 0.001) and to control condition in intention-to-treat analyses (ITT) (P < 0.001). Individuals in the telephone condition took more responsible gambling actions. The letter condition had better outcomes than the control in the ITT-only analysis (P < 0.001). More than 93% were still customers a year after the intervention. CONCLUSIONS Personal contact with high-expenditure gambling customers in Norway that provided individualized feedback on expenditures was associated with reduced theoretical losses and greater use of responsible gambling tools over a 12-month period, compared with no contact. Telephone intervention with customers had a larger impact than a mailed letter.",2020,The phone condition was superior to both the letter and control conditions in per protocol (p<.001) and to control condition in intention to treat analyses (ITT) (p<.001).,"['Customers of Norsk Tipping (NT) gambling platforms, Norway', 'Mean age 53.4 years, 19% were women, mean yearly loss for 2016 was 88,197 NoK. Interventions and comparator Feedback intervention by telephone, letter, or a no-contact control condition', '1,003 statistical triplets from the top 0.5% of customers based upon annual expenditure, matched on sex, age, and net losses']","['phone and letter-based motivational interventions', 'Telephone intervention', 'motivational contact']","['responsible gambling actions', 'gambling theoretical loss, derived from the Norsk Tipping customer database', 'theoretic loss', 'responsible gambling customer actions and whether the participant was retained as a NT customer']","[{'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0041095', 'cui_str': 'Triplets'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]","[{'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0333118', 'cui_str': 'Retained (qualifier value)'}]",,0.231814,The phone condition was superior to both the letter and control conditions in per protocol (p<.001) and to control condition in intention to treat analyses (ITT) (p<.001).,"[{'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Jonsson', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Hodgins', 'Affiliation': 'Department of Psychology, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Munck', 'Affiliation': 'Department of Education and Special Education, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Carlbring', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}]","Addiction (Abingdon, England)",['10.1111/add.14982'] 285,31658923,Psychological Symptoms and Rates of Performance Validity Improve Following Trauma-Focused Treatment in Veterans with PTSD and History of Mild-to-Moderate TBI.,"OBJECTIVE Iraq and Afghanistan Veterans with posttraumatic stress disorder (PTSD) and traumatic brain injury (TBI) history have high rates of performance validity test (PVT) failure. The study aimed to determine whether those with scores in the invalid versus valid range on PVTs show similar benefit from psychotherapy and if psychotherapy improves PVT performance. METHOD Veterans (N = 100) with PTSD, mild-to-moderate TBI history, and cognitive complaints underwent neuropsychological testing at baseline, post-treatment, and 3-month post-treatment. Veterans were randomly assigned to cognitive processing therapy (CPT) or a novel hybrid intervention integrating CPT with TBI psychoeducation and cognitive rehabilitation strategies from Cognitive Symptom Management and Rehabilitation Therapy (CogSMART). Performance below standard cutoffs on any PVT trial across three different PVT measures was considered invalid (PVT-Fail), whereas performance above cutoffs on all measures was considered valid (PVT-Pass). RESULTS Although both PVT groups exhibited clinically significant improvement in PTSD symptoms, the PVT-Pass group demonstrated greater symptom reduction than the PVT-Fail group. Measures of post-concussive and depressive symptoms improved to a similar degree across groups. Treatment condition did not moderate these results. Rate of valid test performance increased from baseline to follow-up across conditions, with a stronger effect in the SMART-CPT compared to CPT condition. CONCLUSION Both PVT groups experienced improved psychological symptoms following treatment. Veterans who failed PVTs at baseline demonstrated better test engagement following treatment, resulting in higher rates of valid PVTs at follow-up. Veterans with invalid PVTs should be enrolled in trauma-focused treatment and may benefit from neuropsychological assessment after, rather than before, treatment.",2020,"Although both PVT groups exhibited clinically significant improvement in PTSD symptoms, the PVT-Pass group demonstrated greater symptom reduction than the PVT-Fail group.","['Veterans with PTSD and History of Mild-to-Moderate TBI', 'Veterans with invalid PVTs', 'Veterans (N = 100) with PTSD, mild-to-moderate TBI history, and cognitive complaints underwent neuropsychological testing at baseline, post-treatment, and 3-month post-treatment', 'Iraq and Afghanistan Veterans with posttraumatic stress disorder (PTSD) and traumatic brain injury']","['PVT', 'cognitive processing therapy (CPT) or a novel hybrid intervention integrating CPT with TBI psychoeducation and cognitive rehabilitation strategies from Cognitive Symptom Management and Rehabilitation Therapy (CogSMART']","['Measures of post-concussive and depressive symptoms', 'PVT performance', 'symptom reduction', 'performance validity test (PVT) failure', 'PTSD symptoms', 'Rate of valid test performance', 'psychological symptoms', 'Psychological Symptoms and Rates of Performance Validity']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0231173', 'cui_str': 'Invalidism (finding)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychologic Tests'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0022066', 'cui_str': 'Republic of Iraq'}, {'cui': 'C0001732', 'cui_str': 'Afghanistan'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C4521399', 'cui_str': 'LT'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0525041', 'cui_str': 'Cognitive Symptoms'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}]",,0.0222698,"Although both PVT groups exhibited clinically significant improvement in PTSD symptoms, the PVT-Pass group demonstrated greater symptom reduction than the PVT-Fail group.","[{'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Jurick', 'Affiliation': 'VA San Diego Healthcare System (VASDHS), San Diego, CA, USA.'}, {'ForeName': 'Laura D', 'Initials': 'LD', 'LastName': 'Crocker', 'Affiliation': 'VA San Diego Healthcare System (VASDHS), San Diego, CA, USA.'}, {'ForeName': 'Victoria C', 'Initials': 'VC', 'LastName': 'Merritt', 'Affiliation': 'VA San Diego Healthcare System (VASDHS), San Diego, CA, USA.'}, {'ForeName': 'Samantha N', 'Initials': 'SN', 'LastName': 'Hoffman', 'Affiliation': 'VA San Diego Healthcare System (VASDHS), San Diego, CA, USA.'}, {'ForeName': 'Amber V', 'Initials': 'AV', 'LastName': 'Keller', 'Affiliation': 'VA San Diego Healthcare System (VASDHS), San Diego, CA, USA.'}, {'ForeName': 'Graham M L', 'Initials': 'GML', 'LastName': 'Eglit', 'Affiliation': 'VA San Diego Healthcare System (VASDHS), San Diego, CA, USA.'}, {'ForeName': 'Kelsey R', 'Initials': 'KR', 'LastName': 'Thomas', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Sonya B', 'Initials': 'SB', 'LastName': 'Norman', 'Affiliation': 'VA San Diego Healthcare System (VASDHS), San Diego, CA, USA.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Schiehser', 'Affiliation': 'VA San Diego Healthcare System (VASDHS), San Diego, CA, USA.'}, {'ForeName': 'Carie S', 'Initials': 'CS', 'LastName': 'Rodgers', 'Affiliation': 'PsychArmor Institute, San Diego, CA, USA.'}, {'ForeName': 'Elizabeth W', 'Initials': 'EW', 'LastName': 'Twamley', 'Affiliation': 'VA San Diego Healthcare System (VASDHS), San Diego, CA, USA.'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Jak', 'Affiliation': 'VA San Diego Healthcare System (VASDHS), San Diego, CA, USA.'}]",Journal of the International Neuropsychological Society : JINS,['10.1017/S1355617719000997'] 286,32141817,"Vitamin D decreases CD40L gene expression in ulcerative colitis patients: A randomized, double-blinded, placebo-controlled trial.","BACKGROUND/AIMS The interaction of CD40 ligand (CD40L) and CD40 triggers the induction of pro-inflammatory cytokines. It has been proposed that vitamin D deficiency might be an important factor, which causes or aggregates the autoimmune situations. The aim of the present study was to assess the effect of vitamin D on CD40L gene expression in patients with ulcerative colitis (UC). MATERIALS AND METHODS Ninety mild-to-moderate UC patients were randomized to receive a single injection of 7.5 mg cholecalciferol or 1 mL normal saline. At baseline and 90 days following the intervention, RNA samples from whole blood were obtained. Fold changes in CD40L mRNA expression were determined for each patient using the 2-ΔΔCq method. The data were analyzed. RESULTS The serum levels of vitamin D and calcium increased only in the vitamin D group (p<0.05). Relative to baseline values, the CD40L gene expression fold change was significantly lower in the vitamin D group compared with the placebo group (median±interquartile range: 0.34±0.30 vs 0.43±1.20, respectively, p=0.016). CONCLUSION The results of this study showed that vitamin D administration in mild-to-moderate UC patients led to the downregulation of the CD40L gene, which is an essential part of inflammatory pathways.",2020,The serum levels of vitamin D and calcium increased only in the vitamin D group (p<0.05).,"['Ninety mild-to-moderate UC patients', 'mild-to-moderate UC patients', 'patients with ulcerative colitis (UC', 'ulcerative colitis patients']","['placebo', 'cholecalciferol or 1 mL normal saline', 'vitamin D', 'Vitamin D']","['CD40L gene expression fold change', 'CD40L gene expression', 'serum levels of vitamin D and calcium', 'CD40L mRNA expression']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009324', 'cui_str': 'Inflammatory Bowel Disease, Ulcerative Colitis Type'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0242215', 'cui_str': 'Cholecalciferols'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]","[{'cui': 'C0167627', 'cui_str': 'T-B Cell Activating Molecule'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",90.0,0.506681,The serum levels of vitamin D and calcium increased only in the vitamin D group (p<0.05).,"[{'ForeName': 'Amrollah', 'Initials': 'A', 'LastName': 'Sharifi', 'Affiliation': 'Golestan Research Center of Gastroenterology and Hepatology (GRCGH), School of Health, Golestan University of Medical Sciences (GOUMS), Gorgan, Iran.'}, {'ForeName': 'Homayoon', 'Initials': 'H', 'LastName': 'Vahedi', 'Affiliation': 'Digestive Disease Research Center, Digestive Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Honarvar', 'Affiliation': 'Health Management and Social Development Research Center, School of Health, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Taghi', 'Initials': 'T', 'LastName': 'Amiriani', 'Affiliation': 'Golestan Research Center of Gastroenterology and Hepatology (GRCGH), School of Health, Golestan University of Medical Sciences (GOUMS), Gorgan, Iran.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Nikniaz', 'Affiliation': 'Gastrointestinal Diseases Research Center, School of Health, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Esmaeil Yousefi', 'Initials': 'EY', 'LastName': 'Rad', 'Affiliation': 'Nutritional Health Research Center, School of Health, Lorestan University of Medical Sciences, Khorramabad, Iran.'}, {'ForeName': 'Mohammad Javad', 'Initials': 'MJ', 'LastName': 'Hosseinzadeh-Attar', 'Affiliation': 'Department of Clinical Nutrition, Tehran University of Medical Sciences School of Nutritional Sciences and Dietetics, Tehran, Iran.'}]",The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology,['10.5152/tjg.2020.181028'] 287,30685701,Low-dose augmentation with buprenorphine increases emotional reactivity but not reward activity in treatment resistant mid- and late-life depression.,"Buprenorphine is currently being studied for treatment-resistant depression because of its rapid effect, relative safety, and unique pharmacodynamics. To understand the neural impact of buprenorphine in depression, we examined acute limbic and reward circuit changes during an intervention with low-dose buprenorphine augmentation pharmacotherapy. Mid and late-life adults with major depression (N = 31) who did not completely respond to an adequate trial of venlafaxine were randomized to augmentation with low-dose buprenorphine or matching placebo. We investigated early neural changes using functional magnetic resonance imaging (fMRI) from pre-randomization to 3 weeks using both an emotional reactivity task and a gambling task. We tested if: 1) there were significant neural changes acutely per intervention group, and 2) if acute neural changes were associated with depressive symptom change over 8 weeks using both the total score and the dysphoria subscale of the Montgomery Asberg Depression Rating Scale. Participants in both the buprenorphine and placebo groups showed similar changes in depressive symptoms. Neither the emotional reactivity nor gambling task resulted in significant neural activation changes from pre-randomization to 3-weeks. In both groups, increases in rostral anterior cingulate (rACC) and ventromedial prefrontal cortex (vmPFC) activation during the emotional reactivity task were associated with overall symptom improvement. In the buprenorphine but not the placebo group, increased activation in left anterior insula (aINS) and bilateral middle frontal gyrus (MFG) was associated with improvement on the dysphoria subscale. Activation changes in the reward task were not associated with buprenorphine. This is the first study to show an association between acute neural changes during emotion reactivity and changes in depression severity with buprenorphine treatment.",2019,"In the buprenorphine but not the placebo group, increased activation in left anterior insula (aINS) and bilateral middle frontal gyrus (MFG) was associated with improvement on the dysphoria subscale.",['Mid and late-life adults with major depression (N\u202f=\u202f31) who did not completely respond to an adequate trial of'],"['placebo', 'buprenorphine augmentation pharmacotherapy', 'venlafaxine', 'buprenorphine', 'buprenorphine or matching placebo', 'Buprenorphine', 'functional magnetic resonance imaging (fMRI']","['total score and the dysphoria subscale of the Montgomery Asberg Depression Rating Scale', 'emotional reactivity', 'emotional reactivity nor gambling task', 'activation in left anterior insula (aINS) and bilateral middle frontal gyrus (MFG', 'depressive symptoms', 'depressive symptom change', 'dysphoria subscale', 'rostral anterior cingulate (rACC) and ventromedial prefrontal cortex (vmPFC) activation', 'neural activation changes']","[{'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C4554154', 'cui_str': 'Completely - dosing instruction fragment (qualifier value)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0233477', 'cui_str': 'Dysphoric mood (finding)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C0228259', 'cui_str': 'Anterior insula (body structure)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C3163631', 'cui_str': 'Rostral'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C3850122', 'cui_str': 'Ventral Medial Prefrontal Cortex'}]",31.0,0.0672229,"In the buprenorphine but not the placebo group, increased activation in left anterior insula (aINS) and bilateral middle frontal gyrus (MFG) was associated with improvement on the dysphoria subscale.","[{'ForeName': 'Chemin', 'Initials': 'C', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry, Keelung Chang Chung Memorial Hospital, Keelung, Taiwan.'}, {'ForeName': 'Helmet T', 'Initials': 'HT', 'LastName': 'Karim', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Pecina', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Howard J', 'Initials': 'HJ', 'LastName': 'Aizenstein', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA; Department of Bioengineering, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Evan D', 'Initials': 'ED', 'LastName': 'Kharasch', 'Affiliation': 'Department of Anesthesiology, The Center for Clinical Pharmacology, St. Louis College of Pharmacy, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Charles F', 'Initials': 'CF', 'LastName': 'Reynolds Iii', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Jordan F', 'Initials': 'JF', 'LastName': 'Karp', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA. Electronic address: karpjf@upmc.edu.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.101679'] 288,29489721,Post-Exercise Ingestion of Low or High Molecular Weight Glucose Polymer Solution Does Not Improve Cycle Performance in Female Athletes.,"ABSTRACT Mock, MG, Hirsch, KR, Blue, MNM, Trexler, ET, Roelofs, EJ, and Smith-Ryan, AE. Postexercise ingestion of low or high molecular weight glucose polymer solution does not improve cycle performance in female athletes. J Strength Cond Res 35(1): 124-131, 2021-The current study sought to evaluate the effects of postexercise ingestion of a high molecular weight (HMW) glucose polymer solution compared with an isocaloric low molecular weight (LMW) solution or placebo (PLA) on subsequent cycling performance in female athletes. In a randomized, double-blind, placebo-controlled, cross-over design, 10 competitive female cyclists (Mean ± SD; Age = 25.7 ± 5.0 years; V̇o2peak = 49.7 ± 4.3 ml·kg-1·min-1) completed 3 testing sessions separated by 7-10 days. Visits consisted of a ride-to-exhaustion (RTE) at 75% V̇o2peak, followed by immediate consumption of 700 ml containing either: 1.2 g·kg-1 LMW (maltodextrin/dextrose/fructose); 1.2 g·kg-1 HMW (Vitargo); or 0.066 g·kg-1 PLA (noncaloric flavoring). After 2 hours of rest, subjects performed a 15-minute time trial (TT). Respiratory exchange ratio (RER) was assessed via indirect calorimetry during exercise. Total body water (TBW) was measured using bioelectrical impedance to assess fluid balance. When covaried for estrogen, there was no treatment effect on distance (km; p = 0.632) or power output (watts; p = 0.974) during the 15-minute TT. Respiratory exchange ratio was not significantly different during the LMW and HWM TTs (p > 0.999), but both were significantly higher than PLA (p = 0.039, p = 0.001, respectively). Changes in total body water pre-exercise to postexercise were not significantly different between trials (p = 0.777). Despite benefits of HMW on cycling performance previously reported in males, current results demonstrate no ergogenic effect of HMW or LMW in females. Sex differences in substrate utilization may account for the discrepancy, and further research involving performance nutrition for female athletes is merited.",2021,Changes in TBW pre- to post-exercise were not significantly different between trials (p=0.777).,"['10 competitive female cyclists (Mean ± SD; Age = 25.7 ± 5.0 yrs; VO2peak = 49.7 ± 4.3 ml[BULLET OPERATOR]kg[BULLET OPERATOR]min', 'Female Athletes', 'female athletes']","['isocaloric low molecular weight solution (LMW) or placebo (PLA', 'placebo', 'LMW (maltodextrin/dextrose/fructose', 'HMW', 'post-exercise ingestion of a high molecular weight glucose polymer solution (HMW', 'Low or High Molecular Weight Glucose Polymer Solution']","['Total body water (TBW', 'RER', 'TBW pre- to post-exercise', 'Cycle Performance', 'Respiratory exchange ratio (RER']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517759', 'cui_str': 'Four point three'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C0391940', 'cui_str': 'Fructose measurement (procedure)'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0017696', 'cui_str': 'Polyglucoses'}]","[{'cui': 'C0429632', 'cui_str': 'Total body water (observable entity)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient (observable entity)'}]",,0.68622,Changes in TBW pre- to post-exercise were not significantly different between trials (p=0.777).,"[{'ForeName': 'Meredith G', 'Initials': 'MG', 'LastName': 'Mock', 'Affiliation': 'Department of Exercise and Sport Science, Applied Physiology Laboratory, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Katie R', 'Initials': 'KR', 'LastName': 'Hirsch', 'Affiliation': 'Department of Exercise and Sport Science, Applied Physiology Laboratory, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Malia N M', 'Initials': 'MNM', 'LastName': 'Blue', 'Affiliation': 'Department of Exercise and Sport Science, Applied Physiology Laboratory, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Eric T', 'Initials': 'ET', 'LastName': 'Trexler', 'Affiliation': 'Department of Exercise and Sport Science, Applied Physiology Laboratory, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Erica J', 'Initials': 'EJ', 'LastName': 'Roelofs', 'Affiliation': 'Nutrition, Health, and Human Performance Department, Meredith College, Raleigh, North Carolina.'}, {'ForeName': 'Abbie E', 'Initials': 'AE', 'LastName': 'Smith-Ryan', 'Affiliation': 'Department of Exercise and Sport Science, Applied Physiology Laboratory, University of North Carolina, Chapel Hill, North Carolina.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002560'] 289,31982581,"Sleep, Growth, and Puberty After 2 Years of Prolonged-Release Melatonin in Children With Autism Spectrum Disorder.","OBJECTIVE A recent 3-month double-blind, placebo-controlled study demonstrated efficacy and safety of pediatric prolonged-release melatonin (PedPRM) for insomnia in children with autism spectrum disorder. This study examined the long-term effects of PedPRM treatment on sleep, growth, body mass index, and pubertal development. METHOD Eighty children and adolescents (2-17.5 years of age; 96% with autism spectrum disorder) who completed the double-blind, placebo-controlled trial were given 2 mg, 5 mg, or 10 mg PedPRM nightly up to 104 weeks, followed by a 2-week placebo period to assess withdrawal effects. RESULTS Improvements in child sleep disturbance and caregiver satisfaction with child sleep patterns, quality of sleep, and quality of life were maintained throughout the 104-week treatment period (p < .001 versus baseline for all). During the 2-week withdrawal placebo period, measures declined compared with the treatment period but were still improved compared with baseline. PedPRM was generally safe; the most frequent treatment-related adverse events were fatigue (6.3%), somnolence (6.3%), and mood swings (4.2%). Changes in mean weight, height, body mass index, and pubertal status (Tanner staging done by a physician) were within normal ranges for age with no evidence of delay in body mass index or pubertal development. CONCLUSION Nightly PedPRM at optimal dose (2, 5, or 10 mg nightly) is safe and effective for long-term treatment in children and adolescents with autism spectrum disorder and insomnia. There were no observed detrimental effects on children's growth and pubertal development and no withdrawal or safety issues related to the use or discontinuation of the drug. CLINICAL TRIAL REGISTRATION INFORMATION Efficacy and Safety of Circadin in the Treatment of Sleep Disturbances in Children With Neurodevelopment Disabilities; https://clinicaltrials.gov/; NCT01906866.",2021,There were no observed detrimental effects on children's growth and pubertal development and no withdrawal or safety issues related to the use or discontinuation of the drug.,"['children with autism spectrum disorder (ASD', 'Children With Autism Spectrum Disorder', 'children and adolescents with ASD and insomnia', 'Eighty children and adolescents (96% ASD) ages 2-17.5 years who completed the double-blind']","['PedPRM', 'placebo', 'child-appropriate prolonged-release melatonin (PedPRM']","['withdrawal effects', 'sleep, growth, body mass index, and pubertal development', 'Sleep, Growth, and Puberty', 'safe and effective', ""child sleep disturbance, and caregivers' satisfaction of their child's sleep patterns, quality of sleep and quality of life"", 'mean weight, height, body mass index (BMI) and pubertal status (Tanner staging done by a physician', 'somnolence', ""children's growth and pubertal development and no withdrawal or safety""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4544856', 'cui_str': 'Prolonged-release (release characteristic)'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1627769', 'cui_str': 'Pubertal'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0034011', 'cui_str': 'Puberty'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0474396', 'cui_str': 'Sleep pattern finding'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep (observable entity)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0034380'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0335730', 'cui_str': 'Tanner (occupation)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",80.0,0.196118,There were no observed detrimental effects on children's growth and pubertal development and no withdrawal or safety issues related to the use or discontinuation of the drug.,"[{'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Malow', 'Affiliation': 'Sleep Division, Vanderbilt University Medical Center, Nashville, Tennessee. Electronic address: beth.malow@vumc.org.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Findling', 'Affiliation': 'Kennedy Krieger Institute/Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Carmen M', 'Initials': 'CM', 'LastName': 'Schroder', 'Affiliation': 'Strasbourg University Hospital, France, and CNRS UPR 3212, Institute of Cellular and Integrative Neurosciences, Strasbourg, France.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Maras', 'Affiliation': 'Yulius Academy, Yulius Mental Health Organization, Dordrecht, The Netherlands.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Breddy', 'Affiliation': 'Pharmastat Consulting Ltd, Canterbury, United Kingdom.'}, {'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Nir', 'Affiliation': 'Neurim Pharmaceuticals Ltd, Tel Aviv, Israel.'}, {'ForeName': 'Nava', 'Initials': 'N', 'LastName': 'Zisapel', 'Affiliation': 'Neurim Pharmaceuticals Ltd, Tel Aviv, Israel.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gringras', 'Affiliation': ""Children's Sleep Medicine, Evelina London Children's Hospital, Guy's and St Thomas', London, United Kingdom.""}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.12.007'] 290,31983371,Impact of Combined Transcranial Direct Current Stimulation and Speech-language Therapy on Spontaneous Speech in Aphasia: A Randomized Controlled Double-blind Study.,"OBJECTIVE Aphasia recovery depends on neural reorganization, which can be enhanced by speech-language therapy and noninvasive brain stimulation. Several studies suggested that transcranial direct current stimulation (tDCS) associated with speech-language therapy may improve verbal performance evaluated by analytic tests, but none focused on spontaneous speech. We explored the effect of bihemispheric tDCS on spontaneous speech in patients with poststroke aphasia. METHODS In this multicentric controlled randomized cross-over double-blind study, we included 10 patients with poststroke aphasia (4 had aphasia >6 months and 6 with aphasia <6 months). We combined the sessions of speech-language therapy and bihemispheric tDCS (2 mA, 20 min). After three baseline speech evaluations (1/week), two different conditions were randomly consecutively proposed: active and sham tDCS over 3 weeks with 1 week of washout in between. The main outcome measure was the number of different nouns used in 2 min to answer the question ""what is your job."" RESULTS There was no significant difference between conditions concerning the main outcome measure (p = .47) nor in the number of verbs, adjectives, adverbs, pronouns, repetitions, blank ideas, ideas, utterances with grammatical errors or paraphasias used. Other cognitive functions (verbal working memory, neglect, or verbal fluency) were not significantly improved in the tDCS group. No adverse events occurred. CONCLUSION Our results differed from previous studies using tDCS to improve naming in patients with poststroke aphasia possibly due to bihemispheric stimulation, rarely used previously. The duration of the rehabilitation period was short given the linguistic complexity of the measure. This negative result should be confirmed by larger studies with ecological measures.",2020,"Other cognitive functions (verbal working memory, neglect, or verbal fluency) were not significantly improved in the tDCS group.","['10 patients with poststroke aphasia (4 had aphasia >6\xa0months and 6 with aphasia', 'Spontaneous Speech in Aphasia', 'patients with poststroke aphasia']","['speech-language therapy and bihemispheric tDCS', 'tDCS', 'bihemispheric tDCS', 'transcranial direct current stimulation (tDCS', 'active and sham tDCS', 'Combined Transcranial Direct Current Stimulation and Speech-language Therapy']","['number of verbs, adjectives, adverbs, pronouns, repetitions, blank ideas, ideas, utterances with grammatical errors or paraphasias used', 'spontaneous speech', 'cognitive functions (verbal working memory, neglect, or verbal fluency', 'adverse events', 'verbal performance', 'number of different nouns used in 2\xa0min to answer the question ""what is your job']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003537', 'cui_str': 'Anepia'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0037817', 'cui_str': 'Speech'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0023017', 'cui_str': 'Language Therapy'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0234488', 'cui_str': 'Paraphasia (finding)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0028811', 'cui_str': 'Occupations'}]",10.0,0.137263,"Other cognitive functions (verbal working memory, neglect, or verbal fluency) were not significantly improved in the tDCS group.","[{'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Guillouët', 'Affiliation': 'Rehabilitation Unit, Raymond Poincaré Hospital, Garches 92380, France.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Cogné', 'Affiliation': 'Rehabilitation Unit, University Hospital, Rennes 35000, France.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Saverot', 'Affiliation': 'Rehabilitation Unit, MGEN, Maisons-Laffitte 78600, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Roche', 'Affiliation': 'Rehabilitation Unit, Raymond Poincaré Hospital, Garches 92380, France.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Pradat-Diehl', 'Affiliation': 'Rehabilitation Unit, hôpital Pitié-Salpêtrière, AP-HP, Paris 75013, France.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Weill-Chounlamountry', 'Affiliation': 'Rehabilitation Unit, hôpital Pitié-Salpêtrière, AP-HP, Paris 75013, France.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Ramel', 'Affiliation': 'Rehabilitation Unit, hôpital Pitié-Salpêtrière, AP-HP, Paris 75013, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Taratte', 'Affiliation': 'Rehabilitation Unit, MGEN, Maisons-Laffitte 78600, France.'}, {'ForeName': 'Anne-Gaëlle', 'Initials': 'AG', 'LastName': 'Lachasse', 'Affiliation': 'Rehabilitation Unit, MGEN, Maisons-Laffitte 78600, France.'}, {'ForeName': 'Jean-Arthur', 'Initials': 'JA', 'LastName': 'Haulot', 'Affiliation': 'Rehabilitation Unit, MGEN, Maisons-Laffitte 78600, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Vaugier', 'Affiliation': ""Inserm, Centre d'Investigation Clinique 1429, AP-HP, Raymond Poincaré hospital, Garches 92380, France.""}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Barbot', 'Affiliation': ""Inserm, Centre d'Investigation Clinique 1429, AP-HP, Raymond Poincaré hospital, Garches 92380, France.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Azouvi', 'Affiliation': 'Rehabilitation Unit, Raymond Poincaré Hospital, Garches 92380, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Charveriat', 'Affiliation': 'Rehabilitation Unit, Raymond Poincaré Hospital, Garches 92380, France.'}]",Journal of the International Neuropsychological Society : JINS,['10.1017/S1355617719001036'] 291,31961489,Effectiveness of Stepped-Care Intervention in Overweight and Obese Patients With Medial Tibiofemoral Osteoarthritis: A Randomized Controlled Trial.,"OBJECTIVE To test the effectiveness of a 32-week, stepped-care intervention on disease remission rates in overweight and obese patients with medial tibiofemoral osteoarthritis (OA) compared to controls. METHODS In this randomized controlled trial, eligible participants were ≥50 years of age with a body mass index of ≥28 kg/m 2 and radiographic evidence of medial tibiofemoral OA. Participants were randomized to stepped-care (n = 87) or control group (n = 84). The stepped-care group received a 2-step intervention. The first step consisted of an 18-week diet and exercise program. The second step consisted of 4 treatment subgroups: 1) diet and exercise maintenance; 2) cognitive-behavioral therapy; 3) unloader knee brace; and 4) muscle strengthening exercises. Allocation into subgroups was based on disease remission state and clinical characteristics. The primary end point was the disease remission rate (yes/no) at 32 weeks, which was reached when participants achieved the Patient Acceptable Symptom State cutoff value for pain and for the patient global assessment of disease activity and/or functional impairment. RESULTS Disease remission at 32 weeks was achieved by 18 of 68 (26%) in the control group and 32 of 82 (39%) in the stepped-care group (difference 12.6% [95% confidence interval -2.3, 27.4], P = 0.10). The stepped-care group showed an improvement in pain and function between baseline and 20 weeks. While functional improvement was maintained at 32 weeks, pain levels tended to get worse between weeks 20 and 32. CONCLUSION The proposed intervention did not promote a significant difference in the rate of disease remission in comparison to the control group for overweight or obese patients with medial tibiofemoral OA.",2021,The proposed intervention did not promote a significant difference in the rate of disease remission in comparison to control group for overweight or obese people with medial tibiofemoral OA.,"['eligible participants were ≥50 years-old with a body mass index ≥28 kg', 'overweight and obese people with medial tibiofemoral osteoarthritis (OA', 'overweight and obese people with medial tibiofemoral osteoarthritis']","['18-week diet and exercise program', '32-week stepped-care intervention', 'diet and exercise maintenance; (2) cognitive behavioural therapy (CBT); (3) unloader knee brace and; (4) muscle strengthening exercises', 'stepped-care']","['Disease remission', 'patient acceptable symptom state (PASS) for pain plus the patient global assessment of disease activity and/or functional impairment', 'disease remission rate', 'disease remission rates', 'pain and function', 'rate of disease remission', 'pain levels']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0006086', 'cui_str': 'Braces'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",,0.150396,The proposed intervention did not promote a significant difference in the rate of disease remission in comparison to control group for overweight or obese people with medial tibiofemoral OA.,"[{'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Robbins', 'Affiliation': 'The University of Sydney and Royal North Shore Hospital, Saint Leonards, New South Wales, Australia.'}, {'ForeName': 'Luciano R S', 'Initials': 'LRS', 'LastName': 'Melo', 'Affiliation': 'The Sax Institute, Haymarket, New South Wales, Australia.'}, {'ForeName': 'Hema', 'Initials': 'H', 'LastName': 'Urban', 'Affiliation': 'The University of Sydney and Royal North Shore Hospital, Saint Leonards, New South Wales, Australia.'}, {'ForeName': 'Leticia A', 'Initials': 'LA', 'LastName': 'Deveza', 'Affiliation': 'The University of Sydney and Royal North Shore Hospital, Saint Leonards, New South Wales, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Asher', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Johnson', 'Affiliation': 'The University of Sydney and Royal North Shore Hospital, Saint Leonards, New South Wales, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Hunter', 'Affiliation': 'The University of Sydney and Royal North Shore Hospital, Saint Leonards, New South Wales, Australia.'}]",Arthritis care & research,['10.1002/acr.24148'] 292,31960175,Experience Versus Report: Where Are Changes Seen After Exposure-Based Cognitive-Behavioral Therapy? A Randomized Controlled Group Treatment of Childhood Social Anxiety Disorder.,"A considerable number of children and adolescents with social anxiety disorder (SAD) do not benefit from treatment as much as expected. However, treatment success should not be measured with social anxiety reports alone; the cognitive, behavioral, and physiological components of social stress should also be assessed. The authors examined an exposure-based SAD-specific group cognitive behavioral therapy (CBT) in a randomized controlled trial (N = 67, age 9-13 years, blind randomized allocation to treatment [CBT; n = 31] and waitlist control [WLC; n = 36] groups). Success was operationalized as a clinically significant reduction of symptoms measured with SAD-specific questionnaires, structured interviews, and changes in response to the Trier Social Stress Test (TSST). In the CBT group, there was a trend toward a significant increase in positive cognitions in the TSST after treatment (d = 0.37), whereas these positive cognitions decreased in the WLC group (d = 0.40). No significant results involving group appeared for negative cognitions, behavior and physiology. Children in the CBT group, but not parents, further reported less social anxiety in one questionnaire from pre- to post-treatment (d = 0.89). A structured interview confirmed a decrease in severity of SAD in the CBT group. While the gold standard of a blind interview showed efficacy of treatment, not all trait and state measures demonstrated similar success patterns.Trial registration Eligibility criteria and some of the dependent variables (cognitions, physiology) for treatment success were registered with the German Research Foundation (TU 78/5-2, HE 3342/4-2) prior to recruitment. Clinical assessment of diagnosis and behavioral data were not a priori planned as outcome measures for this trial and therefore analyzed in a post-hoc approach.",2020,"In the CBT group, there was a trend toward a significant increase in positive cognitions in the TSST after treatment (d = 0.37), whereas these positive cognitions decreased in the WLC group (d = 0.40).","['N\u2009=\u200967, age 9-13\xa0years', 'children and adolescents with social anxiety disorder (SAD', 'Childhood Social Anxiety Disorder']","['WLC', 'exposure-based SAD-specific group cognitive behavioral therapy (CBT', 'CBT', 'waitlist control [WLC', 'TSST']","['severity of SAD', 'SAD-specific questionnaires, structured interviews, and changes in response to the Trier Social Stress Test (TSST', 'negative cognitions, behavior and physiology', 'positive cognitions', 'social anxiety']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0031572', 'cui_str': 'Social Anxiety Disorder'}, {'cui': 'C0270305', 'cui_str': 'Avoidant disorder of childhood (disorder)'}]","[{'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0065404', 'cui_str': 'Tri (L)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0424166', 'cui_str': 'Social Anxiety'}]",,0.0322738,"In the CBT group, there was a trend toward a significant increase in positive cognitions in the TSST after treatment (d = 0.37), whereas these positive cognitions decreased in the WLC group (d = 0.40).","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Asbrand', 'Affiliation': 'Department of Psychology, University of Freiburg, Freiburg im Breisgau, Germany. julia.asbrand@psychologie.uni-freiburg.de.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Heinrichs', 'Affiliation': 'Department of Psychology, University of Bremen, Bremen, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Schmidtendorf', 'Affiliation': 'Department of Psychology, University of Braunschweig, Braunschweig, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Nitschke', 'Affiliation': 'Department of Psychology, University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Brunna', 'Initials': 'B', 'LastName': 'Tuschen-Caffier', 'Affiliation': 'Department of Psychology, University of Freiburg, Freiburg im Breisgau, Germany.'}]",Child psychiatry and human development,['10.1007/s10578-019-00954-w'] 293,31958976,Evaluating the Feasibility of Implementing an HIV Prevention Intervention for Incarcerated African American Men: Lessons Learned From a Pilot Study.,"This pilot study evaluated the feasibility of implementing an evidence-based, culturally adapted HIV intervention with substance-using African American men in a prison setting. We recruited 60, soon-to-be released African American male prisoners from a larger study ( N = 211) to be randomly selected for participation in the group-based HIV intervention, Real Men Are Safe-Culturally Adapted (REMAS-CA). Participants who were not selected for participation in the intervention received standard Centers for Disease Control and Prevention HIV prevention counseling education, provided during participant assessment in the larger study. Nearly all of the participants who were selected to participate (87%) completed the REMAS-CA intervention. To examine feasibility, data were collected about any revisions made to the HIV intervention components for the prison setting, time needed to implement the program in full, details of implementing the intervention to ensure participation and maintain retention, and participant perception of the intervention. Revisions to the intervention included reducing the number of sessions from five to three, modifying the protocol language based on the setting, and removing six activities deemed inappropriate and/or unallowable by the prison officials. The cultural considerations and intervention, overall, were well received by the participants. However, several revisions made specific to the prison and its administration could affect the potential effectiveness of the intervention. Future research is needed to determine the effectiveness of REMAS-CA among this community.",2020,"This pilot study evaluated the feasibility of implementing an evidence-based, culturally adapted HIV intervention with substance-using African American men in a prison setting.","['We recruited 60, soon-to-be released African American male prisoners from a larger study ( N = 211', 'African American men in a prison setting', 'Participants who were not selected for participation in the intervention received', 'Incarcerated African American Men']","['standard Centers for Disease Control and Prevention HIV prevention counseling education', 'HIV Prevention Intervention', 'HIV intervention, Real Men Are Safe-Culturally Adapted (REMAS-CA', 'REMAS-CA intervention']",[],"[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0036849', 'cui_str': 'Set'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0007670', 'cui_str': 'CDC'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]",[],,0.0185619,"This pilot study evaluated the feasibility of implementing an evidence-based, culturally adapted HIV intervention with substance-using African American men in a prison setting.","[{'ForeName': 'Carlos C', 'Initials': 'CC', 'LastName': 'Mahaffey', 'Affiliation': 'Oklahoma State University, Stillwater, OK, USA.'}, {'ForeName': 'Danelle', 'Initials': 'D', 'LastName': 'Stevens-Watkins', 'Affiliation': 'University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'A Kathleen', 'Initials': 'AK', 'LastName': 'Burlew', 'Affiliation': 'University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Myles D', 'Initials': 'MD', 'LastName': 'Moody', 'Affiliation': 'University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Paris B', 'Initials': 'PB', 'LastName': 'Wheeler', 'Affiliation': 'University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Shawndaya', 'Initials': 'S', 'LastName': 'Thrasher', 'Affiliation': 'University of Kentucky, Lexington, KY, USA.'}]",Health promotion practice,['10.1177/1524839919896786'] 294,31536806,Menopausal Hormone Therapy and Risks of First Hospitalized Heart Failure and its Subtypes During the Intervention and Extended Postintervention Follow-up of the Women's Health Initiative Randomized Trials.,"BACKGROUND We assessed whether postmenopausal hormone therapy (HT) was associated with incident heart failure (HF) and its subtypes and examined whether there was a modifying effect of age on the associations. METHODS AND RESULTS Postmenopausal women aged 50-79 enrolled in the Women's Health Initiative HT trials were analyzed. The 16,486 women with a uterus were randomized to receive conjugated equine estrogens (CEE 0.625 mg/day) plus medroxyprogesterone acetate (MPA 2.5 mg/day) or placebo, and 10,739 women with prior hysterectomy were randomized to receive CEE (0.625 mg/day) alone or placebo. Incident HF was defined as the first HF hospitalization. HF with reduced ejection fraction (HFrEF) or preserved EF (HFpEF) was defined as EF < 50% or ≥ 50%. During the intervention phase, median follow-up was 5.6 years in the CEE-plus-MPA trial and 7.2 years in the CEE-alone trial. During the cumulative follow-up of 18.9 years, women randomized to HT vs placebo in the 2 combined trials had incidence rates of 3.90 vs 3.89 per 1000 person-years for total HF; 1.25 vs 1.40 per 1000 person-years for HFrEF, and 1.88 vs 1.79 per 1000 person-years for HFpEF, respectively. There were no significant effects of HT on the risk of total incident HF or its subtypes in either trial, and age at randomization did not significantly modify the results. CONCLUSIONS Postmenopausal HT did not alter the risk of hospitalization for HF or its subtypes during the intervention or cumulative 18.9 years of follow-up, and results did not vary significantly by age at randomization. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT0000611 https://clinicaltrials.gov/ct2/show/NCT00000611?cond=women%27s±health±initiative&rank=5.",2020,"There were no significant effects of HT on the risk of total incident HF or its subtypes in either trial, and age at randomization did not significantly modify the results. ","[""Postmenopausal women aged 50-79 enrolled in the Women's Health Initiative HT trials were analyzed"", '16,486 women with a uterus', '10,739 women with prior hysterectomy']","['HT vs. placebo', 'HT', 'postmenopausal hormone therapy (HT', 'CEE (0.625 mg/day) alone or placebo', 'conjugated equine estrogens (CEE 0.625 mg/day) plus medroxyprogesterone acetate (MPA 2.5 mg/day) or placebo']","['risk of total incident HF', 'risk of hospitalization for HF', 'incidence rates', 'HF with reduced ejection fraction (HFrEF) or preserved EF (HFpEF']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0080339', 'cui_str': 'Womens Health'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}, {'cui': 'C0042149', 'cui_str': 'Womb'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0046018', 'cui_str': 'CEES'}, {'cui': 'C4517467', 'cui_str': 'Zero point six two five'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0065864', 'cui_str': 'medroxyprogesterone acetate'}, {'cui': 'C3844011', 'cui_str': '2.5'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}]",79.0,0.223619,"There were no significant effects of HT on the risk of total incident HF or its subtypes in either trial, and age at randomization did not significantly modify the results. ","[{'ForeName': 'Longjian', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Epidemiology and Biostatistics, Dornsife School of Public Health, Drexel University, Philadelphia, PA. Electronic address: LL85@Drexel.edu.'}, {'ForeName': 'Liviu', 'Initials': 'L', 'LastName': 'Klein', 'Affiliation': 'Division of Cardiology, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Eaton', 'Affiliation': 'Department of Family Medicine, Alpert Medical School of Brown University, and Department of Epidemiology, Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'Gurusher', 'Initials': 'G', 'LastName': 'Panjrath', 'Affiliation': 'George Washington University School of Medicine and Health Sciences, Washington, DC.'}, {'ForeName': 'Lisa Warsinger', 'Initials': 'LW', 'LastName': 'Martin', 'Affiliation': 'George Washington University School of Medicine and Health Sciences, Washington, DC.'}, {'ForeName': 'Claudia U', 'Initials': 'CU', 'LastName': 'Chae', 'Affiliation': 'Cardiology Division, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Greenland', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Donald M', 'Initials': 'DM', 'LastName': 'Lloyd-Jones', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Wactawski-Wende', 'Affiliation': 'Department of Epidemiology and Environmental Health, School of Public Health and Health Professions, University at Buffalo, Buffalo NY.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School and Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA.""}]",Journal of cardiac failure,['10.1016/j.cardfail.2019.09.006'] 295,31409691,Maternal Voice and Infant Sleep in the Neonatal Intensive Care Unit.,"BACKGROUND Approximately 10% of US newborns require a NICU. We evaluated whether the NICU acoustic environment affects neonatal sleep and whether exposure to the mother's voice can modulate that impact. METHODS In a level IV NICU with single-infant rooms, 47 neonates underwent 12-hour polysomnography. Their mothers were recorded reading children's books. Continuous maternal voice playback was randomized to either the first or second 6 hours of the polysomnogram. Regression models were used to examine sleep-wake stages, entropy, EEG power, and the probability of awakening in response to ambient noise during and without voice playback. RESULTS After epochs with elevated noise, the probability was higher with (versus without) maternal voice exposure of neonates staying asleep ( P = .009). However, the 20 neonates born at ≥35 weeks' gestation, in contrast to those born at 33 to 34 weeks, showed an age-related increase in percent time awake ( R 2 = 0.52; P < .001), a decrease in overall sleep ( R 2 = 0.52; P < .001), a reduction in rapid eye movement sleep bouts per hour ( R 2 = 0.35; P = .003), and an increase in sleep-wake entropy ( R 2 = 0.52; P < .001) all confined solely to the 6 hours of maternal voice exposure. These associations remained significant ( P = .02 to P < .001) after adjustment for neurologic examination scores and ambient noise. CONCLUSIONS Hospitalized newborns born at ≥35 weeks' gestation but not at 33 to 34 weeks' gestation show increasing wakefulness in response to their mother's voice. However, exposure to the mother's voice during sleep may also help protect newborns from awakening after bursts of loud hospital noise.",2019,"CONCLUSIONS Hospitalized newborns born at ≥35 weeks' gestation but not at 33 to 34 weeks' gestation show increasing wakefulness in response to their mother's voice.","['47 neonates underwent 12-hour polysomnography', 'Continuous maternal voice playback']",['NICU acoustic environment'],"['rapid eye movement sleep bouts', 'neurologic examination scores and ambient noise', 'overall sleep', 'sleep-wake entropy', 'maternal voice exposure of neonates staying asleep', 'Maternal Voice and Infant Sleep', 'percent time awake']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0042939', 'cui_str': 'Voice'}]","[{'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0037322', 'cui_str': 'Sleep, Fast-Wave'}, {'cui': 'C0027853', 'cui_str': 'Neurological Examination'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0234422', 'cui_str': 'Awake (finding)'}]",47.0,0.093909,"CONCLUSIONS Hospitalized newborns born at ≥35 weeks' gestation but not at 33 to 34 weeks' gestation show increasing wakefulness in response to their mother's voice.","[{'ForeName': 'Renée A', 'Initials': 'RA', 'LastName': 'Shellhaas', 'Affiliation': 'Departments of Pediatrics and shellhaa@med.umich.edu.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Burns', 'Affiliation': 'Michigan Tech Research Institute, Michigan Technological University, Ann Arbor, Michigan; and.'}, {'ForeName': 'John D E', 'Initials': 'JDE', 'LastName': 'Barks', 'Affiliation': 'Departments of Pediatrics and.'}, {'ForeName': 'Fauziya', 'Initials': 'F', 'LastName': 'Hassan', 'Affiliation': 'Departments of Pediatrics and.'}, {'ForeName': 'Ronald D', 'Initials': 'RD', 'LastName': 'Chervin', 'Affiliation': 'Sleep Disorders Center, University of Michigan, Ann Arbor, Michigan; and.'}]",Pediatrics,['10.1542/peds.2019-0288'] 296,31939316,Association of oral estradiol dose/levels with coagulation measures in early/late postmenopausal women.,"Objective: This study evaluated associations of estradiol (E2) dose and serum E2 levels with coagulation/anti-coagulation measures in early (<6 years) compared with late (≥10 years) postmenopausal women. Methods: Postmenopausal women from the REPLENISH trial tested four formulations of oral combined E2 and progesterone compared with placebo. Mixed-effects linear models tested the association of E2 dose and serum E2 levels with the prothrombin time (PT), the activated partial thromboplastin time (APTT), antithrombin (ATHRM), fibrinogen (FIBRINO), protein C (PROTC), and protein S (PROTS), assessed five times over 12 months. Results: Among 1215 early and 297 late postmenopausal women, the E2 dose was statistically significantly inversely associated with the APTT in early postmenopause, PROTC in late postmenopause, and with the PT, ATHRM, and PROTS in both groups. Serum E2 levels were statistically significantly inversely associated with the APTT, PROTS, and FIBRINO in early postmenopause, the PT in late postmenopause, and ATHRM and PROTC in both groups. With longer time since menopause, the inverse E2 dose effect and serum E2 effects became stronger. Conclusion: Increasing E2 dose and serum E2 levels were associated with changes in coagulation/anti-coagulation measures. The associations were stronger among women ≥10 years since menopause when initiating E2. The timing of E2 therapy, E2 dose, and serum E2 levels relative to time since menopause may modify the venous thromboembolism risk.",2020,"Serum E2 levels were statistically significantly inversely associated with the APTT, PROTS, and FIBRINO in early postmenopause, the PT in late postmenopause, and ATHRM and PROTC in both groups.","['Methods: Postmenopausal women', '1215 early and 297 late postmenopausal women', 'early (<6\u2009years) compared with late (≥10\u2009years) postmenopausal women', 'early/late postmenopausal women']","['placebo', 'oral combined E2 and progesterone', 'oral estradiol', 'estradiol (E2) dose and serum E2 levels with coagulation/anti-coagulation measures']","['Serum E2 levels', 'Increasing E2 dose and serum E2 levels', 'association of E2 dose and serum E2 levels with the prothrombin time (PT), the activated partial thromboplastin time (APTT), antithrombin (ATHRM), fibrinogen (FIBRINO), protein C (PROTC), and protein S (PROTS']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin Time'}, {'cui': 'C0030605', 'cui_str': 'Activated Partial Thromboplastin Time'}, {'cui': 'C0003440', 'cui_str': 'Direct Thrombin Inhibitors'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0611128', 'cui_str': 'protein C (synaptosomal)'}, {'cui': 'C0072393', 'cui_str': 'Protein S'}]",1215.0,0.0190154,"Serum E2 levels were statistically significantly inversely associated with the APTT, PROTS, and FIBRINO in early postmenopause, the PT in late postmenopause, and ATHRM and PROTC in both groups.","[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Sriprasert', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'H N', 'Initials': 'HN', 'LastName': 'Hodis', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bernick', 'Affiliation': 'TherapeuticsMD, Boca Raton, FL, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mirkin', 'Affiliation': 'TherapeuticsMD, Boca Raton, FL, USA.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Mack', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}]",Climacteric : the journal of the International Menopause Society,['10.1080/13697137.2019.1703939'] 297,31763622,Association between Pre-Intervention Physical Activity Level and Treatment Response to Exercise Therapy in Persons with Knee Osteoarthritis - An Exploratory Study.,"Objective Examine whether pre-intervention physical activity (PA) level is associated with achieving a positive treatment response of pain and/or function improvement after a 12-week exercise intervention in participants with knee osteoarthritis (OA). Methods We performed a secondary analysis of a randomized, single-blind comparative effectiveness trial showing similar treatment effects between Tai Chi mind-body exercise and standard physical therapy intervention for knee OA. Baseline PA was assessed by Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire and, in a subsample, by tri-axial accelerometers. OMERACT-OARSI dichotomous responder criteria was used for clinically meaningful improvement at follow-up. Associations between baseline self-reported PA by CHAMPS and outcomes of responders vs. non-responders (reference group) were assessed using logistic regressions, adjusting for demographic covariates. We compared objectively-measured PA by accelerometry between responders vs. non-responders using Wilcoxon tests. Results Our sample consisted of 166 participants with knee OA who completed both baseline and 12-week post-intervention evaluations: mean age 60.7 year (SD 10.5), BMI 32.4 kg/m 2 (6.9), 119 (72%) women, and 138 (83%) OMERACT-OARSI responders. Neither time spent in total PA (OR 1.00; 95% CI 0.96, 1.03) nor time in moderate-to-vigorous (MV) PA (OR 1.01; 95% CI 0.93, 1.09) at pre-intervention were associated with being a responder. Similar findings were observed in 42 accelerometry sub-cohort participants. Conclusion Pre-intervention PA level (subjective report or objective measurement) was not associated with whether an individual will achieve favorable treatment outcomes after a 12-week exercise intervention, suggesting that regardless of pre-intervention PA level, individuals will likely benefit from structured exercise interventions.",2019,"Neither time spent in total PA (OR 1.00; 95% CI 0.96, 1.03) nor time in moderate-to-vigorous (MV) PA (OR 1.01; 95% CI 0.93, 1.09) at pre-intervention were associated with being a responder.","['166 participants with knee OA who completed both baseline and 12-week post-intervention evaluations: mean age 60.7 year (SD 10.5), BMI 32.4 kg/m 2 (6.9), 119 (72%) women, and 138 (83%) OMERACT-OARSI responders', 'knee OA', 'Persons with Knee Osteoarthritis - An Exploratory Study', 'participants with knee osteoarthritis (OA']","['exercise intervention', 'Tai Chi mind-body exercise and standard physical therapy intervention', 'pre-intervention physical activity (PA) level', 'Pre-Intervention Physical Activity Level and Treatment Response to Exercise Therapy']","['time in moderate-to-vigorous (MV) PA', 'time spent in total PA']","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C4517709', 'cui_str': '32.4 (qualifier value)'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",166.0,0.0504539,"Neither time spent in total PA (OR 1.00; 95% CI 0.96, 1.03) nor time in moderate-to-vigorous (MV) PA (OR 1.01; 95% CI 0.93, 1.09) at pre-intervention were associated with being a responder.","[{'ForeName': 'Alison H', 'Initials': 'AH', 'LastName': 'Chang', 'Affiliation': 'Department of Physical Therapy and Human Movement Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Jungwha', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'Rheumatology Division, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Lori Lyn', 'Initials': 'LL', 'LastName': 'Price', 'Affiliation': 'Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA and Tufts Clinical and Translational Science Institute, Tufts University, Boston, MA, USA.'}, {'ForeName': 'Augustine C', 'Initials': 'AC', 'LastName': 'Lee', 'Affiliation': 'Center for Complementary and Integrative Medicine; Division of Rheumatology, Allergy & Immunology; Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Kieran F', 'Initials': 'KF', 'LastName': 'Reid', 'Affiliation': 'Nutrition, Exercise Physiology and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, USA.'}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Fielding', 'Affiliation': 'Nutrition, Exercise Physiology and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, USA.'}, {'ForeName': 'Jeffrey B', 'Initials': 'JB', 'LastName': 'Driban', 'Affiliation': 'Center for Complementary and Integrative Medicine; Division of Rheumatology, Allergy & Immunology; Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Harvey', 'Affiliation': 'Center for Complementary and Integrative Medicine; Division of Rheumatology, Allergy & Immunology; Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Chenchen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Center for Complementary and Integrative Medicine; Division of Rheumatology, Allergy & Immunology; Tufts Medical Center, Boston, MA, USA.'}]",ACR open rheumatology,['10.1002/acr2.1013'] 298,31466895,VR Simulation Leads to Enhanced Procedural Confidence for Surgical Trainees.,"OBJECTIVE Active learning techniques result in greater knowledge acquisition compared to passive methods. For medical students with limited hands-on operative experiences, virtual reality platforms represent active learning and may enhance procedural training. We hypothesize that virtual reality simulators like Toolkit for Illustration of Procedures in Surgery (TIPS) are a more effective modality in teaching laparoscopic surgical techniques to medical students when compared to passive learning tools like videos. DESIGN In this crossover study, participants were randomly assigned to perform either a TIPS laparoscopic appendectomy followed by video of a laparoscopic cholecystectomy, or video of a laparoscopic appendectomy followed by TIPS laparoscopic cholecystectomy. A knowledge assessment followed each intervention. A postsurvey was used to gather feedback and subjective impressions of the learning experience. SETTING University of Central Florida College of Medicine. PARTICIPANTS Second, third, and fourth-year medical students (n = 37). RESULTS Validation of the content assessments revealed strong internal consistency (Cronbach's α = 0.73). A 2-tailed Fisher's exact test revealed that the video had greater ease of use (p = 0.032), but TIPS had greater utility as a learning tool (p < 0.001) and instilled greater confidence in the ability to reproduce procedural steps (p < 0.001). A 2-tailed t test of the average content quiz scores revealed no significant difference in percentage correct between groups on the laparoscopic appendectomy quiz (p = 0.772), but a difference favoring video learning on the laparoscopic cholecystectomy quiz (p = 0.042) CONCLUSIONS: Video and TIPS both enhanced different aspects of student learning; however, the active TIPS platform produced greater confidence in the ability to reproduce the steps of the procedure and had greater utility as a learning strategy. Videos are simple to use and can serve a complementary role in curriculum design.",2020,"A 2-tailed t test of the average content quiz scores revealed no significant difference in percentage correct between groups on the laparoscopic appendectomy quiz (p = 0.772), but a difference favoring video learning on the laparoscopic cholecystectomy quiz (p = 0.042) CONCLUSIONS: Video and TIPS","['Second, third, and fourth-year medical students (n = 37', 'University of Central Florida College of Medicine']","['TIPS laparoscopic appendectomy followed by video of a laparoscopic cholecystectomy, or video of a laparoscopic appendectomy followed by TIPS laparoscopic cholecystectomy', 'Video and TIPS']",[],"[{'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0016253', 'cui_str': 'Florida'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]","[{'cui': 'C0339897', 'cui_str': 'TIPSS'}, {'cui': 'C0372525', 'cui_str': 'Endoscopic appendectomy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}]",[],,0.0281266,"A 2-tailed t test of the average content quiz scores revealed no significant difference in percentage correct between groups on the laparoscopic appendectomy quiz (p = 0.772), but a difference favoring video learning on the laparoscopic cholecystectomy quiz (p = 0.042) CONCLUSIONS: Video and TIPS","[{'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Lesch', 'Affiliation': 'University of Central Florida College of Medicine, Orlando, Florida.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Johnson', 'Affiliation': 'University of Central Florida College of Medicine, Orlando, Florida.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Peters', 'Affiliation': 'University of Florida College of Engineering, Gainesville, Florida.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Cendán', 'Affiliation': 'University of Central Florida College of Medicine, Orlando, Florida. Electronic address: juan.cendan@ucf.edu.'}]",Journal of surgical education,['10.1016/j.jsurg.2019.08.008'] 299,32492080,Effect of Aspirin vs Placebo on the Prevention of Depression in Older People: A Randomized Clinical Trial.,"Importance Depression is associated with increased inflammation, which may precede its onset, especially in older people. Some preclinical data suggest potential antidepressant effects of aspirin, supported by limited observational data suggesting lower rates of depression in individuals treated with aspirin. There currently appears to be no evidence-based pharmacotherapies for the primary prevention of depression. Objective To determine whether low-dose aspirin (100 mg) reduces the risk of depression in healthy older adults. Design, Setting, and Participants This double-blinded, placebo-controlled randomized clinical trial was a substudy of the Aspirin in Reducing Events in the Elderly (ASPREE) trial, which examined if aspirin increased healthy life span, defined as survival free of dementia and disability. The prespecified secondary outcome was depression. Individuals of all races/ethnicities older than 70 years in Australia, as well as white individuals older than 70 years and black and Hispanic individuals older than 65 years in the United States, were included. Interventions Participants were randomized to aspirin (100 mg daily) or placebo, with a median (interquartile range) follow-up of 4.7 (3.5-5.6) years. Main Outcomes and Measures The primary outcome was a proxy measure of major depressive disorder defined as a score of 8 or more on the Center for Epidemiologic Studies Depression 10-item (CES-D-10) scale. Results Of the 19 114 participants enrolled in the trial, 9525 received aspirin and 9589 received a placebo. The mean (SD) age was 75.2 (4.0) years in the aspirin group and 75.1 (4.5) years in the placebo group; 9531 (56.4%) were women. Participants' demographics and clinical characteristics at baseline were similar between groups. A total of 79 886 annual CES-D-10 measurements were taken, with a mean of 4.2 measurements per participant. There were no significant differences at annual visits in the proportions of CES-D-10 scores of 8 or more between the aspirin and placebo groups. The incidence rate of new CES-D-10 scores of 8 or more was 70.4 events per 1000 person-years in the aspirin group and 69.1 in the placebo group (hazard ratio, 1.02 [95% CI, 0.96-1.08]; P = .54). Conclusions and Relevance Low-dose aspirin did not prevent depression in this large-scale study of otherwise healthy older adults. Trial Registration ClinicalTrials.gov Identifier: NCT01038583.",2020,There were no significant differences at annual visits in the proportions of CES-D-10 scores of 8 or more between the aspirin and placebo groups.,"['The mean (SD) age was 75.2\u2009(4.0) years in the aspirin group and 75.1\u2009(4.5) years in the placebo group; 9531 (56.4%) were women', 'otherwise healthy older adults', 'Individuals of all races/ethnicities older than 70 years in Australia, as well as white individuals older than 70 years and black and Hispanic individuals older than 65 years in the United States, were included', '19\u202f114 participants enrolled in the trial, 9525 received', 'healthy older adults', 'Older People']","['Aspirin vs Placebo', 'Aspirin', 'aspirin', 'low-dose aspirin', 'placebo']","['risk of depression', 'healthy life span', 'survival free of dementia and disability', 'depression', 'proxy measure of major depressive disorder defined as a score of 8 or more on the Center for Epidemiologic Studies Depression 10-item', 'incidence rate of new CES-D-10\u2009scores']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0870809', 'cui_str': 'Lifespan'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002783', 'cui_str': 'Studies, Epidemiologic'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0559741', 'cui_str': 'Item score'}]",19114.0,0.692445,There were no significant differences at annual visits in the proportions of CES-D-10 scores of 8 or more between the aspirin and placebo groups.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berk', 'Affiliation': 'The Institute for Mental and Physical Health and Clinical Translation Strategy Research Centre, Deakin University School of Medicine, Geelong, Australia.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Woods', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Raj C', 'Initials': 'RC', 'LastName': 'Shah', 'Affiliation': ""Rush Alzheimer's Disease Center, Department of Family Medicine, Rush University Medical Center, Chicago, Illinois.""}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Elsdon', 'Initials': 'E', 'LastName': 'Storey', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Sharyn', 'Initials': 'S', 'LastName': 'Fitzgerald', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Lockery', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Mohebbi', 'Affiliation': 'The Institute for Mental and Physical Health and Clinical Translation Strategy Research Centre, Deakin University School of Medicine, Geelong, Australia.'}, {'ForeName': 'Seetal', 'Initials': 'S', 'LastName': 'Dodd', 'Affiliation': 'The Institute for Mental and Physical Health and Clinical Translation Strategy Research Centre, Deakin University School of Medicine, Geelong, Australia.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Murray', 'Affiliation': 'Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Minneapolis, Minnesota.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Stocks', 'Affiliation': 'Discipline of General Practice, Adelaide Medical School, University of Adelaide, Australia.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Fitzgerald', 'Affiliation': 'Epworth Centre for Innovation in Mental Health, the Epworth Clinic, Epworth Healthcare, Camberwell, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mazza', 'Affiliation': 'The Institute for Mental and Physical Health and Clinical Translation Strategy Research Centre, Deakin University School of Medicine, Geelong, Australia.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Agustini', 'Affiliation': 'The Institute for Mental and Physical Health and Clinical Translation Strategy Research Centre, Deakin University School of Medicine, Geelong, Australia.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.1214'] 300,31238312,"Risk Factors and Nomogram for Pancreatic Stone Formation in Chronic Pancreatitis over a Long-Term Course: A Cohort of 2,153 Patients.","BACKGROUND Pancreatic stones are pathognomonic of chronic pancreatitis (CP). This study aimed to determine the incidence, identify risk factors, and develop a nomogram for pancreatic stones in CP patients. METHODS Patients with CP admitted to our center from January 2000 to December 2013 were enrolled. Cumulative rates of pancreatic stones after the onset of CP and after the diagnosis of CP were calculated. Patients were randomly assigned, in a 2:1 ratio, to the training and validation cohort. Based on the training cohort, risk factors were identified through Cox proportional hazards regression model, and nomogram was developed. Internal and external validations were performed based on the training and validation cohort, respectively. RESULTS With a total of 2,153 CP patients, pancreatic stones were detected in 1,626 (75.5%) patients, with a median follow-up of 7.8 years. Age at the onset of CP, body mass index, smoking, diabetes mellitus, pancreatic pseudocyst, biliary stricture, severe acute pancreatitis, and type of pain were identified risk factors for pancreatic stones development. The nomogram with these 8 factors achieved good accuracy. CONCLUSIONS The nomogram achieved an individualized prediction of pancreatic stones development in CP. It may help the management of pancreatic stones.",2020,The nomogram achieved an individualized prediction of pancreatic stones development in CP.,"['CP patients', 'Patients with CP admitted to our center from January 2000 to December 2013 were enrolled', '2,153 Patients']",[],"['pancreatic stones', 'Cumulative rates of pancreatic stones']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0470277', 'cui_str': '2000'}]",[],"[{'cui': 'C0440736', 'cui_str': 'Pancreatic stone (substance)'}]",2153.0,0.0190087,The nomogram achieved an individualized prediction of pancreatic stones development in CP.,"[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Hao', 'Affiliation': 'Department of Gastroenterology, First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Xie', 'Affiliation': 'Department of Gastroenterology, Zhongda Hospital, Southeast University, Nanjing, China.'}, {'ForeName': 'Teng', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Hong-Lei', 'Initials': 'HL', 'LastName': 'Guo', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Ya-Wei', 'Initials': 'YW', 'LastName': 'Bi', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Jun-Tao', 'Initials': 'JT', 'LastName': 'Ji', 'Affiliation': 'Endoscopy Center, Changhai Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xin', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Ting-Ting', 'Initials': 'TT', 'LastName': 'Du', 'Affiliation': 'Endoscopy Center, Changhai Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Jin-Huan', 'Initials': 'JH', 'LastName': 'Lin', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Xiang-Peng', 'Initials': 'XP', 'LastName': 'Zeng', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Wen-Bin', 'Initials': 'WB', 'LastName': 'Zou', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Bai-Rong', 'Initials': 'BR', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Air Force General Hospital, Beijing, China.'}, {'ForeName': 'Zhuan', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Zhi-Jie', 'Initials': 'ZJ', 'LastName': 'Cong', 'Affiliation': 'Department of General Surgery, Renji Hospital, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Rui-Hua', 'Initials': 'RH', 'LastName': 'Shi', 'Affiliation': 'Department of Gastroenterology, Zhongda Hospital, Southeast University, Nanjing, China.'}, {'ForeName': 'Zhao-Shen', 'Initials': 'ZS', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Liang-Hao', 'Initials': 'LH', 'LastName': 'Hu', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China, lianghao-hu@hotmail.com.'}]",Digestion,['10.1159/000500941'] 301,31928846,Clinical and MRI Predictors of Conversion From Mild Behavioural Impairment to Dementia.,"OBJECTIVE As an analogy with mild cognitive impairment (MCI), the mild behavioral impairment (MBI) construct has been proposed as a diagnostic label for those presenting late-onset behavioral symptoms. To date, however, the clinical, cognitive, and structural imaging features associated with an increased risk of conversion from MBI to dementia are poorly understood. METHODS We retrospectively analyzed the cognitive performance and structural brain MRI of 113 subjects, with a clinical follow-up of at least 4 years available. Subjects were randomly assigned to a Group A (56 subjects; age: 65.4 ± 7.9 years, 15 females, MMSE score: 28.4 ± 2.3)) or to a Group B (57 subjects, age: 66.6 ± 6.4, 17 females, MMSE score: 28.0 ± 1.4). In the Group A, cognitive and structural variables were compared between converters (at 4 years) and nonconverters and then verified in the Group B group. RESULTS In the Group A, 14 patients converted to behavioral-variant of frontotemporal dementia (bv-FTD) and 4 to Alzheimer's Disease (AD). Converters presented at baseline lower executive function scores and total Theory of Mind (ToM scores), as well as more severe focal frontal atrophy. In the Group B, 13 subjects converted to bv-FTD and none to AD. The combination of the variables identified in the Group A significantly (p <0.001) discriminated between converters and nonconverters in the Group B with a sensitivity of 0.615 and a specificity of 1 (total accuracy 91.22%). CONCLUSION The combined presence of executive deficit, impaired ToM, and presence of isolated frontal atrophy was associated with risk of progression from MBI to a clinically evident neurodegenerative condition, mainly bv-FTD, over a 4-year period.",2020,"The combination of the variables identified in the Group A significantly (p <0.001) discriminated between converters and nonconverters in the Group B with a sensitivity of 0.615 and a specificity of 1 (total accuracy 91.22%). ","['113 subjects, with a clinical follow-up of at least 4 years available', 'Subjects were randomly assigned to a Group A (56 subjects; age: 65.4 ± 7.9 years, 15 females, MMSE score: 28.4 ± 2.3)) or to a Group B (57 subjects, age: 66.6 ± 6.4, 17 females, MMSE score: 28.0 ± 1.4', ""14 patients converted to behavioral-variant of frontotemporal dementia (bv-FTD) and 4 to Alzheimer's Disease (AD""]",[],"['severe focal frontal atrophy', 'executive function scores and total Theory of Mind (ToM scores']","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C4517822', 'cui_str': '6.4 (qualifier value)'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4011788', 'cui_str': 'Behavioral variant of frontotemporal dementia (disorder)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}]",[],"[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0935573', 'cui_str': 'Mentalizing'}]",113.0,0.0375881,"The combination of the variables identified in the Group A significantly (p <0.001) discriminated between converters and nonconverters in the Group B with a sensitivity of 0.615 and a specificity of 1 (total accuracy 91.22%). ","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Orso', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa (Beatrice Orso, Dario Arnaldi, Federico Massa, Gianluca Serafini, Elisa Doglione, Flavio Nobili, Matteo Pardini), Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mattei', 'Affiliation': 'Bozen Civic Hospital (Chiara Mattei), Bozen, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Arnaldi', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa (Beatrice Orso, Dario Arnaldi, Federico Massa, Gianluca Serafini, Elisa Doglione, Flavio Nobili, Matteo Pardini), Italy; Policlinico S. Martino IRCCS (Dario Arnaldi, Gianluca Serafini, Flavio Nobili, Matteo Pardini), Genova, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Massa', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa (Beatrice Orso, Dario Arnaldi, Federico Massa, Gianluca Serafini, Elisa Doglione, Flavio Nobili, Matteo Pardini), Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Serafini', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa (Beatrice Orso, Dario Arnaldi, Federico Massa, Gianluca Serafini, Elisa Doglione, Flavio Nobili, Matteo Pardini), Italy; Policlinico S. Martino IRCCS (Dario Arnaldi, Gianluca Serafini, Flavio Nobili, Matteo Pardini), Genova, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Plantone', 'Affiliation': 'Neurology Unit, Di Venere Hospital (Domenico Plantone), Bari, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Doglione', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa (Beatrice Orso, Dario Arnaldi, Federico Massa, Gianluca Serafini, Elisa Doglione, Flavio Nobili, Matteo Pardini), Italy.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Grafman', 'Affiliation': 'Cognitive Neuroscience Laboratory, Shirley Ryan Ability Lab (Jordan Grafman), Chicago, IL.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Nobili', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa (Beatrice Orso, Dario Arnaldi, Federico Massa, Gianluca Serafini, Elisa Doglione, Flavio Nobili, Matteo Pardini), Italy; Policlinico S. Martino IRCCS (Dario Arnaldi, Gianluca Serafini, Flavio Nobili, Matteo Pardini), Genova, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pardini', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa (Beatrice Orso, Dario Arnaldi, Federico Massa, Gianluca Serafini, Elisa Doglione, Flavio Nobili, Matteo Pardini), Italy; Policlinico S. Martino IRCCS (Dario Arnaldi, Gianluca Serafini, Flavio Nobili, Matteo Pardini), Genova, Italy. Electronic address: matteo.pardini@unige.it.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2019.12.007'] 302,31305209,Effects of aquatic physiotherapy or health education program in women with fibromyalgia: a randomized clinical trial.,"Background:  Different treatments have been proposed for Fibromyalgia, but only few studies have compared their effects on multiples outcomes over time.  Objective:  The objective of this study was to investigate the effects of aquatic physiotherapy (AP) or a health education program (HEP) in a sample of women with Fibromyalgia (FM).  Methods:  Forty-six women with FM, aged between 25 and 60 years old, whose BMI was less than 30, were assigned to either AP (27 women) or HEP (19 women) groups in a blind randomized clinical trial lasting eleven weeks. Pain (McGill Pain questionnaire), fatigue (Piper Fatigue Scale-Revised), functional capability (Fibromyalgia Impact questionnaire), anxiety (Beck Anxiety Inventory), depression (Beck Depression Inventory) and quality of sleep (Pittsburgh Sleep Quality Index) data were collected at baseline, after six weeks and post intervention. Two-factor mixed-model analysis of variance (ANOVAs) were used to examine the effects of the treatment on each outcome variable.  Results:  The AP and HEP interventions showed statistically significant within-group differences on all outcome measures except reducing the pain. Between-group differences was statistically significant only for impact of FM on the participant's life [ F (1.82,80.41)  = 31,99; p ≤ 0.01] indicating that patients receiving HEP experienced a greater decrease in FIQ than those treated with AP.  Conclusion:  The findings do not allow to affirm that one intervention is superior to the other for the treatment of people with FM. Future studies should investigate whether the combination of HEP and PA can be effective and long-lasting.",2021,The AP and HEP interventions showed statistically significant within-group differences on all outcome measures except reducing the pain.,"['people with FM', 'women with Fibromyalgia (FM', 'Methods: \xa0Forty-six\xa0women with FM, aged between 25 and 60\xa0years old, whose BMI was less than 30, were assigned to either AP (27 women) or', 'women with fibromyalgia']","['aquatic physiotherapy (AP) or a\xa0health education program (HEP', 'aquatic physiotherapy or health education program', 'HEP']","['Pain (McGill Pain questionnaire), fatigue (Piper Fatigue Scale-Revised), functional capability (Fibromyalgia Impact questionnaire), anxiety (Beck Anxiety Inventory), depression (Beck Depression Inventory) and quality of sleep (Pittsburgh Sleep Quality Index) data', 'FIQ', 'pain']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0018701'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0449198', 'cui_str': 'HEP (body structure)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0024985', 'cui_str': 'McGill Pain Questionnaire'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0330232', 'cui_str': 'Piper'}, {'cui': 'C0222045'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory (assessment scale)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep (observable entity)'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}]",27.0,0.220307,The AP and HEP interventions showed statistically significant within-group differences on all outcome measures except reducing the pain.,"[{'ForeName': 'Angélica Cristina Sousa', 'Initials': 'ACS', 'LastName': 'Fonseca', 'Affiliation': 'Department of physiotherapy , Centro Universitário de Formiga - MG (UNIFOR-MG), Formiga, Minas Gerais, Brasil.'}, {'ForeName': 'Priscila Conceição', 'Initials': 'PC', 'LastName': 'Faria', 'Affiliation': 'Department of physiotherapy , Centro Universitário de Formiga - MG (UNIFOR-MG), Formiga, Minas Gerais, Brasil.'}, {'ForeName': 'Marcus Alessandro', 'Initials': 'MA', 'LastName': 'Alcântara', 'Affiliation': 'Universidade Federal dos Vales do Jequitinhonha e Mucuri (UFVJM), Diamantina, Minas Gerais, Brasil.'}, {'ForeName': 'Wálisson Dias', 'Initials': 'WD', 'LastName': 'Pinto', 'Affiliation': 'Department of physiotherapy , Centro Universitário de Formiga - MG (UNIFOR-MG), Formiga, Minas Gerais, Brasil.'}, {'ForeName': 'Letícia Gontijo', 'Initials': 'LG', 'LastName': 'De Carvalho', 'Affiliation': 'Department of physiotherapy , Centro Universitário de Formiga - MG (UNIFOR-MG), Formiga, Minas Gerais, Brasil.'}, {'ForeName': 'Filipe Gustavo', 'Initials': 'FG', 'LastName': 'Lopes', 'Affiliation': 'Universidade Federal dos Vales do Jequitinhonha e Mucuri (UFVJM), Diamantina, Minas Gerais, Brasil.'}, {'ForeName': 'Andrei Pereira', 'Initials': 'AP', 'LastName': 'Pernambuco', 'Affiliation': 'Department of physiotherapy , Centro Universitário de Formiga - MG (UNIFOR-MG), Formiga, Minas Gerais, Brasil.'}]",Physiotherapy theory and practice,['10.1080/09593985.2019.1639229'] 303,31280100,Erector spinae plane block and thoracic paravertebral block for breast surgery compared to IV-morphine: A randomized controlled trial.,"STUDY OBJECTIVE Erector spinae plane (ESP) block is a novel regional anesthesia technique and gaining importance for postoperative pain management. Since it was first described, the clinicians wonder if this new simple technique can replace paravertebral block (PVB). We aimed to compare the postoperative analgesic effect of ESP block and PVB with a control group in breast surgeries. DESIGN Randomized controlled trial. SETTING Operating room. PATIENTS Seventy-five ASA I-II patients aged 25-65, who were scheduled to go under elective unilateral breast surgery for breast cancer were included to the study. INTERVENTIONS Patients were randomized into three groups as ESP, PVB, and Control group. Ultrasound (US) guided ESP block and PVB with 20 ml 0.25% bupivacaine was done preoperatively to the patients according to their groups. MEASUREMENTS All patients were provided with iv patient-controlled analgesia device for postoperative analgesia. Morphine consumptions and numeric rating scale (NRS) scores for pain were recorded at 1st, 6th, 12th and 24th hours postoperatively. MAIN RESULTS There was a statistically significant difference between ESP and Control groups (p < 0,001) and between PVB and Control groups (p < 0,001), while there was no difference between ESP and PVB groups (p > 0,05) for 24-hour morphine consumptions. There was a significant difference between PVB and Control groups for NRS at postoperative 1st and 6th hour (p = 0.018 and p = 0.027 respectively). CONCLUSIONS This study has shown that US guided ESP block and PVB provided adequate analgesia in patients undergoing breast surgery and have an opioid sparing effect by reducing morphine consumption. Clinical Trials Registry: NCT03480958.",2020,"There was a statistically significant difference between ESP and Control groups (p < 0,001) and between PVB and Control groups (p < 0,001), while there was no difference between ESP and PVB groups (p > 0,05) for 24-hour morphine consumptions.","['patients undergoing breast surgery', 'Seventy-five ASA I-II patients aged 25-65, who were scheduled to go under elective unilateral breast surgery for breast cancer were included to the study']","['IV-morphine', 'ESP block and PVB', 'Ultrasound (US) guided ESP block and PVB with 20\u202fml 0.25% bupivacaine', 'Erector spinae plane block and thoracic paravertebral block', 'ESP, PVB, and Control group']",['Morphine consumptions and numeric rating scale (NRS) scores for pain'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0851312', 'cui_str': 'Breast surgery'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0015373', 'cui_str': 'Extrasensory Perception'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",75.0,0.0553276,"There was a statistically significant difference between ESP and Control groups (p < 0,001) and between PVB and Control groups (p < 0,001), while there was no difference between ESP and PVB groups (p > 0,05) for 24-hour morphine consumptions.","[{'ForeName': 'Yavuz', 'Initials': 'Y', 'LastName': 'Gürkan', 'Affiliation': 'Department of Anesthesiology and Reanimation, Kocaeli University Hospital, 41380 Kocaeli, Turkey.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Aksu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Kocaeli University Hospital, 41380 Kocaeli, Turkey. Electronic address: dr.aksu@gmail.com.'}, {'ForeName': 'Alparslan', 'Initials': 'A', 'LastName': 'Kuş', 'Affiliation': 'Department of Anesthesiology and Reanimation, Kocaeli University Hospital, 41380 Kocaeli, Turkey.'}, {'ForeName': 'Ufuk H', 'Initials': 'UH', 'LastName': 'Yörükoğlu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Kocaeli University Hospital, 41380 Kocaeli, Turkey.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2019.06.036'] 304,31840739,"Increasing uptake of National Health Service Health Checks in primary care: a pragmatic randomized controlled trial of enhanced invitation letters in Northamptonshire, England.","BACKGROUND Uptake of NHS Health Checks (NHSHCs) is sub-optimal. This study aimed to increase their uptake using behaviourally informed invitation letters. METHOD Patients registered with 6 general practices in Northamptonshire, England who were eligible for an NHSHC between 10 February 2014 and 31 January 2015 were randomized monthly, using a random number generator, to three trial arms: control (standard invitation), sunk costs (resources already allocated) and counterargument (against common barriers to attendance). The outcome measure was uptake of NHSHC by 12 weeks after 31 January. RESULTS In total, 6331 patients were randomized. After exclusions, due to ineligibility for the NHSHC, data were analysed for N = 6313 patients: N = 2123 control; N = 2085 counterargument; N = 2105 sunk costs. Overall, 2364 (37.45%) patients attended an NHSHC. Both intervention letters increased uptake compared to control, by 5.46% using counterargument (adjusted odds ratio (AOR) 1.32, CI 1.162-1.51, p < 0.001) and 4.33% using sunk costs (AOR 1.246, CI 1.10-1.42, p < 0.001), with no significant difference between the two. CONCLUSION Behaviourally informed invitation letters, containing sunk costs or counterargument messages, can improve the uptake of NHSHCs. The trial was registered with the International Standard Randomised Controlled Trial Registration Number Scheme (ISRCTN57110614).",2021,"Both intervention letters increased uptake compared to control, by 5.46% using counterargument (adjusted odds ratio (AOR)","['6331 patients were randomized', 'primary care', 'Patients registered with 6 general practices in Northamptonshire, England who were eligible for an NHSHC between 10 February 2014 and 31 January 2015', '6313 patients: N\xa0=\xa02123 control; N\xa0=\xa02085 counterargument; N\xa0']","['control (standard invitation), sunk costs (resources already allocated) and counterargument (against common barriers to attendance']",['uptake of NHSHC'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0585825', 'cui_str': 'Patient registered (finding)'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0454868', 'cui_str': 'Northamptonshire (geographic location)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]",[],2015.0,0.246903,"Both intervention letters increased uptake compared to control, by 5.46% using counterargument (adjusted odds ratio (AOR)","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sallis', 'Affiliation': 'Public Health England Behavioural Insights, Public Health England, London, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Gold', 'Affiliation': 'Public Health England Behavioural Insights, Public Health England, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Agbebiyi', 'Affiliation': 'Public Health England Behavioural Insights, Public Health England, London, UK.'}, {'ForeName': 'R J E', 'Initials': 'RJE', 'LastName': 'James', 'Affiliation': 'School of Psychology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Berry', 'Affiliation': 'Department of Health and Social Care, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bonus', 'Affiliation': 'Department of Health and Social Care, London, UK.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Vlaev', 'Affiliation': 'Behavioural Science Group, Warwick Business School, Coventry, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Chadborn', 'Affiliation': 'Public Health England Behavioural Insights, Public Health England, London, UK.'}]","Journal of public health (Oxford, England)",['10.1093/pubmed/fdz134'] 305,31262599,Phase II randomized study on tissue distribution and pharmacokinetics of cisplatin according to different levels of intra-abdominal pressure (IAP) during HIPEC (NCT02949791).,"AIMS To evaluate the effects of high intra-abdominal pressure (IAP) during hyperthermic intraperitoneal chemotherapy (HIPEC) on cisplatin uptake by residual tumor and normal tissues, pharmacokinetics, and short-term surgical outcomes. PATIENTS & METHODS Patients with peritoneal metastasis from colorectal cancer or pseudomyxoma peritonei were randomized to closed-abdomen HIPEC with low-IAP or high-IAP, after complete cytoreduction. High-IAP was obtained increasing the volume of perfusate maintaining constant the cisplatin concentration (42 mg/L). We determined the Platinum concentration using an Inductive Coupled Plasma Mass Spectrometry System. Randomization was stratified according to tumor type. To consider the multiple sampling in the three tissues types of interest, we performed linear mixed models to assess the differences of cisplatin concentration between study arms. We also compared AUC perfusate/plasma ratios (Wilcoxon-Mann-Whitney) and perioperative severe complication rates (chi-square) between study arms. RESULTS 38 cases were randomly assigned to IAP arms (n = 19 each). Median IAPs were 19 mmHg and 11 mmHg in the high and low arms, respectively. Cisplatin concentrations did not differ in the tumor residual tissues and in the muscular fascia [22.8 ng/mg (SD: 25.5) vs. 15.9 ng/mg (SD: 13.3), p = 0.181] and [50.3 ng/mg (SD: 40.1) vs. 42.0 ng/mg (SD: 38.3), p = 0.426, respectively], whereas in the mesenteric peritoneum it did [5.4 ng/mg (SD: 7.82) vs. 2.7 ng/mg (SD: 2.9), p = 0.048]. Pharmacokinetic advantage did not differ between the two arms. High-IAP did not increase perioperative severe complications rate (NCI-CTCAE.v3). CONCLUSIONS high-IAP HIPEC increases cisplatin distribution in the mesenteric peritoneum, is safe, and could be considered to obtain microscopic cytoreduction.",2021,"Cisplatin concentrations did not differ in the tumor residual tissues and in the muscular fascia [22.8 ng/mg (SD: 25.5) vs. 15.9 ng/mg (SD: 13.3), p = 0.181] and [50.3 ng/mg (SD: 40.1) vs. 42.0 ng/mg (SD: 38.3), p = 0.426, respectively], whereas in the mesenteric peritoneum it did [5.4 ng/mg (SD: 7.82) vs. 2.7 ","['38 cases', 'Patients with peritoneal metastasis from colorectal cancer or pseudomyxoma peritonei']","['high intra-abdominal pressure (IAP', 'hyperthermic intraperitoneal chemotherapy (HIPEC', 'closed-abdomen HIPEC with low-IAP or high-IAP', 'cisplatin']","['intra-abdominal pressure (IAP', 'Cisplatin concentrations', 'Pharmacokinetic advantage', 'AUC perfusate/plasma ratios (Wilcoxon-Mann-Whitney) and perioperative severe complication rates', 'Median IAPs', 'perioperative severe complications rate', 'cisplatin uptake by residual tumor and normal tissues, pharmacokinetics, and short-term surgical outcomes']","[{'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346989', 'cui_str': 'Secondary malignant peritoneal deposit'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0033822', 'cui_str': 'Syndrome of Pseudomyxoma Peritonei'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0429218', 'cui_str': 'Abdominal pressure (observable entity)'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0429218', 'cui_str': 'Abdominal pressure (observable entity)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumor'}, {'cui': 'C0332441', 'cui_str': 'Normal tissue (finding)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]",38.0,0.095085,"Cisplatin concentrations did not differ in the tumor residual tissues and in the muscular fascia [22.8 ng/mg (SD: 25.5) vs. 15.9 ng/mg (SD: 13.3), p = 0.181] and [50.3 ng/mg (SD: 40.1) vs. 42.0 ng/mg (SD: 38.3), p = 0.426, respectively], whereas in the mesenteric peritoneum it did [5.4 ng/mg (SD: 7.82) vs. 2.7 ","[{'ForeName': 'Shigeki', 'Initials': 'S', 'LastName': 'Kusamura', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Peritoneal Surface Malignancies Unit, Italy.'}, {'ForeName': 'Norfarizan', 'Initials': 'N', 'LastName': 'Azmi', 'Affiliation': 'Fellow of European School of Peritoneal Surface Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Anesthesiology Unit, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Fumagalli', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Anesthesiology Unit, Italy.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Baratti', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Peritoneal Surface Malignancies Unit, Italy.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Guaglio', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Peritoneal Surface Malignancies Unit, Italy.'}, {'ForeName': 'Adalberto', 'Initials': 'A', 'LastName': 'Cavalleri', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Laboratory of Department of Preventive and Predictive Medicine, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Garrone', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Laboratory of Department of Preventive and Predictive Medicine, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Battaglia', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Peritoneal Surface Malignancies Unit, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Barretta', 'Affiliation': 'Department of Clinical Epidemiology and Trial Organization, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Deraco', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Peritoneal Surface Malignancies Unit, Italy. Electronic address: marcello.deraco@istitutotumori.mi.it.'}]",European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology,['10.1016/j.ejso.2019.06.022'] 306,31838780,Effectiveness of a music intervention on pruritus: an open randomized prospective study.,"BACKGROUND Pruritus is a common symptom in many skin diseases. Music interventions have demonstrated their efficacy in different symptoms or diseases such as pain, depression and anxiety. OBJECTIVE To evaluate the effects of a music intervention on pruritus. PATIENTS AND METHODS A randomized controlled trial was conducted from November 2018 to April 2019. Fifty inpatients with pruritus intensity ≥3/10 in various chronic skin diseases were randomized in a music group or an emollient group. The primary endpoint was the evolution of pruritus as measured by the Numerical Rating Scale before and one hour after the procedure. The secondary judgement criteria were the effects on patient anxiety, the impact of pruritus on the quality of life and patient satisfaction (NCT03701971). RESULTS Fifty patients with chronic pruritus were included, 62% were male, and the average age was 60.7 years. The most common diseases were psoriasis (N = 10), atopic dermatitis (N = 8) and contact eczema (N = 6). The average ItchyQol score was 64.8/110, showing a significant impact on quality of life. The intensity of pruritus decreased more significantly in the music intervention group than in the emollient group: 2.3 (SD 2.1) and 1.2 (SD 1.7), respectively (P < 0.05). There was a decrease in anxiety in both groups, with no statistical significant difference between groups. Among patients who received the music intervention, 64% reported feeling an improvement, 91% would recommend the music intervention, and 64% would like to continue this practice. DISCUSSION Pruritus management is complex and requires first-line aetiological treatment. Aetiological or symptomatic treatments do not always provide enough relief; it is useful to find other therapeutic options. The music intervention has shown interest in our study. Its repeated use over the long term will be interesting to evaluate. As in pain, music may work by activating inhibitory neural circuits. The use of music is a simple method to manage chronic pruritus.",2020,"The intensity of pruritus decreased more significantly in the music intervention group than in the emollient group: 2.3 (SD 2.1) and 1.2 (SD 1.7), respectively (p<0.05).","['November 2018 to April 2019', 'Fifty inpatients with pruritus intensity ≥3/10 in various chronic skin diseases', 'Fifty patients with chronic pruritus were included, 62% were male, the average age was 60.7 years', 'psoriasis (N=10), atopic dermatitis (N=8), contact eczema (N=6']","['Music interventions', 'music group or an emollient group', 'music intervention']","['anxiety', 'pruritus', 'intensity of pruritus', 'average ItchyQol score', 'evolution of pruritus as measured by the Numerical Rating Scale', 'patient anxiety, the impact of pruritus on the quality of life, and patient satisfaction (NCT03701971', 'quality of life']","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1290009', 'cui_str': 'Chronic disease of skin'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0011616', 'cui_str': 'Sensitivity, Contact'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0013983', 'cui_str': 'Emollients'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]",50.0,0.121684,"The intensity of pruritus decreased more significantly in the music intervention group than in the emollient group: 2.3 (SD 2.1) and 1.2 (SD 1.7), respectively (p<0.05).","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Demirtas', 'Affiliation': 'Dermatology department, University Hospital of Brest, Brest, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Houssais', 'Affiliation': 'Dermatology department, University Hospital of Brest, Brest, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tanniou', 'Affiliation': 'Delegation of Clinical Research and Innovation, University Hospital of Brest, Brest, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Misery', 'Affiliation': 'Dermatology department, University Hospital of Brest, Brest, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Brenaut', 'Affiliation': 'Dermatology department, University Hospital of Brest, Brest, France.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16149'] 307,31916605,Prevention of biliary fistula after partial hepatectomy by transcystic biliary drainage: randomized clinical trial.,"BACKGROUND Biliary fistula is one of the most common complications after hepatectomy. This study evaluated the effect of transcystic biliary drainage during hepatectomy on the occurrence of postoperative biliary fistula. METHODS This multicentre RCT was carried out from 2009 to 2016 in nine centres. Patients were randomized to transcystic biliary drainage or no transcystic drainage (control). Patients underwent hepatectomy (more than 2 segments) of non-cirrhotic livers. The primary endpoint was the occurrence of biliary fistula after surgery. Secondary endpoints were morbidity, postoperative mortality, duration of hospital stay, reoperation, readmission to hospital, and complications caused by catheters. Intention-to-treat and per-protocol analyses were performed. RESULTS A total of 310 patients were randomized. In intention-to-treat analysis, there were 158 patients in the transcystic group and 149 in the control group. Seven patients were removed from the per-protocol analysis owing to protocol deviations. The biliary fistula rate was 5·9 per cent in intention-to-treat and 6·0 per cent in per-protocol analyses. The rate was similar in the transcystic and control groups (5·7 versus 6·0 per cent; P = 1·000). There were no differences in terms of morbidity (49·4 versus 46·3 per cent; P = 0·731), mortality (2·5 versus 4·7 per cent; P = 0·367) and reoperations (4·4 versus 10·1 per cent; P = 1·000). Median duration of hospital stay was longer in the transcystic group (11 versus 10 days; P = 0·042). The biliary fistula risk was associated with the width and length of the hepatic cut surface. CONCLUSION This randomized trial did not demonstrate superiority of transcystic drainage during hepatectomy in preventing biliary fistula. The use of transcystic drainage during hepatectomy to prevent postoperative biliary fistula is not recommended. Registration number: NCT01469442 ( http://www.clinicaltrials.gov).",2020,"There were no differences in terms of morbidity (49·4 versus 46·3 per cent; P = 0·731), mortality (2·5 versus 4·7 per cent; P = 0·367) and reoperations (4·4 versus 10·1 per cent; P = 1·000).","['2009 to 2016 in nine centres', '158 patients in the transcystic group and 149 in the control group', 'biliary fistula after partial hepatectomy by transcystic biliary drainage', '310 patients were randomized']","['hepatectomy', 'transcystic biliary drainage or no transcystic drainage (control', 'transcystic drainage during hepatectomy', 'transcystic biliary drainage during hepatectomy']","['biliary fistula rate', 'occurrence of biliary fistula', 'Median duration of hospital stay', 'biliary fistula risk', 'morbidity', 'mortality', 'morbidity, postoperative mortality, duration of hospital stay, reoperation, readmission to hospital, and complications caused by catheters']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005417', 'cui_str': 'Biliary Fistula'}, {'cui': 'C0193398', 'cui_str': 'Partial hepatectomy (procedure)'}, {'cui': 'C0400745', 'cui_str': 'Biliary drainage (procedure)'}]","[{'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0400745', 'cui_str': 'Biliary drainage (procedure)'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0005417', 'cui_str': 'Biliary Fistula'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}]",158.0,0.238085,"There were no differences in terms of morbidity (49·4 versus 46·3 per cent; P = 0·731), mortality (2·5 versus 4·7 per cent; P = 0·367) and reoperations (4·4 versus 10·1 per cent; P = 1·000).","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Maulat', 'Affiliation': 'Department of Digestive Surgery and Liver Transplantation, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'J-M', 'Initials': 'JM', 'LastName': 'Regimbeau', 'Affiliation': 'Department of Digestive Surgery, Amiens University Hospital, Amiens, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Buc', 'Affiliation': 'Department of Digestive Surgery and Liver Transplantation, Hôtel Dieu, Clermont-Ferrand University Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Boleslawski', 'Affiliation': 'Department of Digestive Surgery and Liver Transplantation, Claude Huriez Hospital, Lille, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Belghiti', 'Affiliation': 'Department of Digestive Surgery and Liver Transplantation, Beaujon Hospital, Clichy, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hardwigsen', 'Affiliation': 'Department of Digestive Surgery, La Conception University Hospital, Marseille, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Vibert', 'Affiliation': 'Department of Digestive Surgery and Liver Transplantation, Centre Hépato-Biliaire, Paul Brousse Hospital, Villejuif, France.'}, {'ForeName': 'J-R', 'Initials': 'JR', 'LastName': 'Delpero', 'Affiliation': 'Department of Digestive Surgery, Paoli Calmettes Institute, Marseille, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Tournay', 'Affiliation': 'Department of Epidemiology and Clinical Research, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Arnaud', 'Affiliation': 'Department of Epidemiology and Clinical Research, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Suc', 'Affiliation': 'Department of Digestive Surgery and Liver Transplantation, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Pessaux', 'Affiliation': 'Department of Digestive Surgery, Strasbourg University Hospital, IRCAD, Strasbourg, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Muscari', 'Affiliation': 'Department of Digestive Surgery and Liver Transplantation, Toulouse University Hospital, Toulouse, France.'}]",The British journal of surgery,['10.1002/bjs.11405'] 308,32009610,The advantage of polyethylene glycol electrolyte solution combined with lactulose in patients with long interval preparation-to-colonoscopy.,"BACKGROUND/AIMS The main aim of the present study was to assess the efficacy of polyethylene glycol electrolyte (PEG) solution combined with lactulose in bowel preparation to find a new method for colonoscopy preparation to improve the quality of colonoscopy in patients with long interval preparation-to-colonoscopy (P-C). MATERIALS AND METHODS A prospective, randomized, endoscopist-blinded and placebo-controlled study was conducted. Three hundred sixty patients who were scheduled for colonoscopy were enrolled in the study. They were randomly divided into the PEG-lactulose group and the PEG-placebo group with 180 patients per arm. Two of the most common methods for estimating the quality of bowel preparation were the use of the Boston Bowel Preparation Scale and the measurement of the Bubble Scale and adenoma detection rate (ADR) as a secondary outcome of observation. RESULTS The PEG-lactulose group had a significant improvement in the quality of bowel preparation compared with the PEG-placebo group including colon cleanliness in interval P-C at 8 and 9 h (p<0.05) and bubble elimination in interval P-C at 5, 6, 7, 8, and 9 h (p<0.05). Compared with the PEG-placebo group, the ADR (23.3% vs. 15.0%, p<0.05) and the size (≤5 mm) of the adenoma (45.2% vs. 18.5%, p<0.05) increased in the PEG-lactulose group, and there were significant differences between the two groups. CONCLUSION PEG solution combined with lactulose can improve the quality of colonoscopy in patients with long interval P-C to allow the patients to select more flexible colonoscopy time. It is worth further popularizing in clinical practice.",2020,"The PEG-lactulose group had a significant improvement in the quality of bowel preparation compared with the PEG-placebo group including colon cleanliness in interval P-C at 8 and 9 h (p<0.05) and bubble elimination in interval P-C at 5, 6, 7, 8, and 9 h (p<0.05).","['patients with long interval preparation-to-colonoscopy', 'patients with long interval preparation-to-colonoscopy (P-C', 'Three hundred sixty patients who were scheduled for colonoscopy were enrolled in the study', 'group with 180 patients per arm']","['polyethylene glycol electrolyte solution combined with lactulose', 'polyethylene glycol electrolyte (PEG) solution combined with lactulose', 'placebo', 'PEG solution combined with lactulose', 'PEG-lactulose', 'PEG-placebo']","['Boston Bowel Preparation Scale and the measurement of the Bubble Scale and adenoma detection rate (ADR', 'quality of colonoscopy', 'quality of bowel preparation', 'ADR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0032483', 'cui_str': 'polyethylene oxide'}, {'cui': 'C3541941', 'cui_str': 'Electrolyte solutions'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0022957', 'cui_str': 'Lactulose'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C4302285', 'cui_str': 'Boston bowel preparation scale (assessment scale)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0222045'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0449207', 'cui_str': 'ADR (body structure)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure (procedure)'}]",360.0,0.131362,"The PEG-lactulose group had a significant improvement in the quality of bowel preparation compared with the PEG-placebo group including colon cleanliness in interval P-C at 8 and 9 h (p<0.05) and bubble elimination in interval P-C at 5, 6, 7, 8, and 9 h (p<0.05).","[{'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Yuanchao', 'Affiliation': ""Department of General Practice, the Shaanxi Provincial People's Hospital, Xi'an, Shaanxi, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xueping', 'Affiliation': ""Department of Clinical Medicine, Xi'an Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Tao', 'Affiliation': ""Department of Gastroenterology, DEPT I, Section 1, the Shaanxi Provincial People's Hospital, Xi'an, Shaanxi, China.""}, {'ForeName': 'Niu', 'Initials': 'N', 'LastName': 'Jianping', 'Affiliation': ""Department of Gastroenterology, DEPT I, Section 1, the Shaanxi Provincial People's Hospital, Xi'an, Shaanxi, China.""}, {'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Man', 'Affiliation': ""Department of Clinical Medicine, Xi'an Medical University, Xi'an, Shaanxi, China.""}]",The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology,['10.5152/tjg.2020.18888'] 309,31306389,Comparision of Low and High Volume of Resistance Training on Body Fat and Blood Biomarkers in Untrained Older Women: A Randomized Clinical Trial.,"ABSTRACT Cunha, PM, Tomeleri, CM, Nascimento, MA, Mayhew, JL, Fungari, E, Cyrino, LT, Barbosa, DS, Venturini, D, and Cyrino, ES. Comparision of low and high volume of resistance training on body fat and blood biomarkers in untrained older women: a randomized clinical trial. J Strength Cond Res 35(1): 1-8, 2021-The purpose of this study was to compare the effects of resistance training (RT) performed with 2 different volumes on body fat and blood biomarkers in untrained older women. Sixty-five physically independent older women (≥60 years) were randomly assigned to one of 3 groups: low-volume (LV) training group, high-volume (HV) training group, and a control group. Both training groups performed RT for 12 weeks, using 8 exercises of 10-15 repetitions maximum for each exercise. The low-volume group performed only a single set per exercise, whereas the HV group performed 3 sets. Anthropometric, body fat (%), trunk fat, triglycerides (TG), total cholesterol, low-density lipoprotein cholesterol (LDL-c), high-density lipoprotein cholesterol, very LDL-c (VLDL-c), glucose (GLU), C-reactive protein (CRP), and composite Z-score were measured. The HV group obtained greater improvements compared with the LV group (p < 0.05) for TG (LV = -10.5% vs. HV = -16.6%), VLDL-c (LV = -6.5% vs. HV = -14.8%), GLU (LV = -4.7% vs. HV = -11.1%), CRP (LV = -13.2% vs. HV = -30.8%), % body fat (LV = -2.4% vs. HV = -6.1%), and composite Z-score (LV = -0.13 ± 0.30 vs. HV = -0.57 ± 0.29). Trunk fat was reduced (p < 0.05) only in the HV group (-6.8%). We conclude that RT performed in higher volume seems to be the most appropriate strategy to reduce body fat (%), trunk fat, improve blood biomarkers, and reduce composite Z-score in older women.",2021,Trunk fat was reduced (p < 0.05) only in the HV group (-6.8%).,"['older women', 'Sixty-five physically independent older women (≥60 years', 'Untrained Older Women', 'untrained older women']","['J Strength Cond Res XX(X', 'Resistance Training', 'resistance training', 'resistance training (RT', 'low-volume (LV) training group, high-volume (HV) training group, and a control group']","['Cunha, PM, Tomeleri, CM, Nascimento, MA, Mayhew, JL, Fungari, E, Trindade, L, Barbosa, DS, Venturini, D, and Cyrino, ES', 'CRP', 'Anthropometric, body fat (%), trunk fat, triglycerides (TG), total cholesterol, low-density lipoprotein cholesterol (LDL-c), high-density lipoprotein cholesterol, very LDL-c (VLDL-c), glucose (GLU), C-reactive protein (CRP), and composite Z-score', 'Trunk fat', 'body fat and blood biomarkers', 'Body Fat and Blood Biomarkers', 'body fat (%), trunk fat, improve blood biomarkers']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0523560', 'cui_str': 'VLDL cholesterol measurement'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0005768'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",65.0,0.0164675,Trunk fat was reduced (p < 0.05) only in the HV group (-6.8%).,"[{'ForeName': 'Paolo M', 'Initials': 'PM', 'LastName': 'Cunha', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Londrina State University, Londrina, Puerto Rico, Brazil.'}, {'ForeName': 'Crisieli M', 'Initials': 'CM', 'LastName': 'Tomeleri', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Londrina State University, Londrina, Puerto Rico, Brazil.'}, {'ForeName': 'Matheus A', 'Initials': 'MA', 'LastName': 'Nascimento', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Londrina State University, Londrina, Puerto Rico, Brazil.'}, {'ForeName': 'Jerry L', 'Initials': 'JL', 'LastName': 'Mayhew', 'Affiliation': 'Exercise Science Program, Truman State University, Kirksville, Missouri; and.'}, {'ForeName': 'Edilaine', 'Initials': 'E', 'LastName': 'Fungari', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Londrina State University, Londrina, Puerto Rico, Brazil.'}, {'ForeName': 'Letícia T', 'Initials': 'LT', 'LastName': 'Cyrino', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Londrina State University, Londrina, Puerto Rico, Brazil.'}, {'ForeName': 'Décio S', 'Initials': 'DS', 'LastName': 'Barbosa', 'Affiliation': 'Clinical Analyses Laboratory, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Venturini', 'Affiliation': 'Clinical Analyses Laboratory, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Edilson S', 'Initials': 'ES', 'LastName': 'Cyrino', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Londrina State University, Londrina, Puerto Rico, Brazil.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003245'] 310,31238954,A gender synchronized family planning intervention for married couples in rural India: study protocol for the CHARM2 cluster randomized controlled trial evaluation.,"BACKGROUND Prior research from India demonstrates a need for family planning counseling that engages both women and men, offers complete family planning method mix, and focuses on gender equity and reduces marital sexual violence (MSV) to promote modern contraceptive use. Effectiveness of the three-session (two male-only sessions and one couple session) Counseling Husbands to Achieve Reproductive Health and Marital Equity (CHARM) intervention, which used male health providers to engage and counsel husbands on gender equity and family planning (GE + FP), was demonstrated by increased pill and condom use and a reduction in MSV. However, the intervention had limited reach to women and was therefore unable to expand access to highly effective long acting reversible contraceptives such as the intrauterine device (IUD). We developed a second iteration of the intervention, CHARM2, which retains the three sessions from the original CHARM but adds female provider- delivered counseling to women and offers a broader array of contraceptives including IUDs. This protocol describes the evaluation of CHARM2 in rural Maharashtra. METHODS A two-arm cluster randomized controlled trial will evaluate CHARM2, a gender synchronized GE + FP intervention. Eligible married couples (n = 1200) will be enrolled across 20 clusters in rural Maharashtra, India. Health providers will be gender-matched to deliver two GE + FP sessions to the married couples in parallel, and then a final session will be delivered to the couple together. We will conduct surveys on demographics as well as GE and FP indicators at baseline, 9-month, and 18-month follow-ups with both men and women, and pregnancy tests at each time point from women. In-depth interviews will be conducted with a subsample of couples (n = 50) and providers (n = 20). We will conduct several implementation and monitoring activities for purposes of assuring fidelity to intervention design and quality of implementation, including recruitment and tracking logs, provider evaluation forms, session observation forms, and participant satisfaction surveys. DISCUSSION We will complete the recruitment of participants and collection of baseline data by July 2019. Findings from this work will offer important insight for the expansion of the national family planning program and improving quality of care for India and family planning interventions globally. TRIAL REGISTRATION ClinicalTrial.gov, NCT03514914 .",2019,"Findings from this work will offer important insight for the expansion of the national family planning program and improving quality of care for India and family planning interventions globally. ","['subsample of couples (n\xa0=\u200950) and providers (n\xa0=\u200920', 'Eligible married couples (n\xa0=\u20091200) will be enrolled across 20 clusters in rural Maharashtra, India', 'married couples in rural India']","['three-session (two male-only sessions and one couple session', 'CHARM2, a gender synchronized GE\u2009+\u2009FP intervention', 'Counseling Husbands to Achieve Reproductive Health and Marital Equity (CHARM) intervention', 'synchronized family planning intervention']",[],"[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}]","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C0242664', 'cui_str': 'Husband (person)'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0009861', 'cui_str': 'Family Planning Services'}]",[],,0.0987769,"Findings from this work will offer important insight for the expansion of the national family planning program and improving quality of care for India and family planning interventions globally. ","[{'ForeName': 'Anvita', 'Initials': 'A', 'LastName': 'Dixit', 'Affiliation': 'Joint Doctoral Program in Public Health (Global Health track), University of California San Diego/San Diego State University, San Diego, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Averbach', 'Affiliation': 'Center on Gender Equity and Health, School of Medicine, University of California San Diego, 9500 Gilman Drive #0507, La Jolla, San Diego, CA, 92093-0507, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Yore', 'Affiliation': 'Center on Gender Equity and Health, School of Medicine, University of California San Diego, 9500 Gilman Drive #0507, La Jolla, San Diego, CA, 92093-0507, USA.'}, {'ForeName': 'Gennifer', 'Initials': 'G', 'LastName': 'Kully', 'Affiliation': 'Center on Gender Equity and Health, School of Medicine, University of California San Diego, 9500 Gilman Drive #0507, La Jolla, San Diego, CA, 92093-0507, USA.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Ghule', 'Affiliation': 'Center on Gender Equity and Health, School of Medicine, University of California San Diego, 9500 Gilman Drive #0507, La Jolla, San Diego, CA, 92093-0507, USA.'}, {'ForeName': 'Madhusudana', 'Initials': 'M', 'LastName': 'Battala', 'Affiliation': 'Population Council, Zone 5A, Ground Floor, India Habitat Center, Lodi Road, New Delhi, 110003, India.'}, {'ForeName': 'Shahina', 'Initials': 'S', 'LastName': 'Begum', 'Affiliation': 'Department of Biostatistics, ICMR-National Institute for Research in Reproductive Health, J.M Street, Parel, Mumbai, 400012, India.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Johns', 'Affiliation': 'Center on Gender Equity and Health, School of Medicine, University of California San Diego, 9500 Gilman Drive #0507, La Jolla, San Diego, CA, 92093-0507, USA.'}, {'ForeName': 'Florin', 'Initials': 'F', 'LastName': 'Vaida', 'Affiliation': 'Center on Gender Equity and Health, School of Medicine, University of California San Diego, 9500 Gilman Drive #0507, La Jolla, San Diego, CA, 92093-0507, USA.'}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Bharadwaj', 'Affiliation': 'Center on Gender Equity and Health, School of Medicine, University of California San Diego, 9500 Gilman Drive #0507, La Jolla, San Diego, CA, 92093-0507, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Wyss', 'Affiliation': 'Center on Gender Equity and Health, School of Medicine, University of California San Diego, 9500 Gilman Drive #0507, La Jolla, San Diego, CA, 92093-0507, USA.'}, {'ForeName': 'Niranjan', 'Initials': 'N', 'LastName': 'Saggurti', 'Affiliation': 'Population Council, Zone 5A, Ground Floor, India Habitat Center, Lodi Road, New Delhi, 110003, India.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Silverman', 'Affiliation': 'Center on Gender Equity and Health, School of Medicine, University of California San Diego, 9500 Gilman Drive #0507, La Jolla, San Diego, CA, 92093-0507, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Raj', 'Affiliation': 'Center on Gender Equity and Health, School of Medicine, University of California San Diego, 9500 Gilman Drive #0507, La Jolla, San Diego, CA, 92093-0507, USA. anraj@ucsd.edu.'}]",Reproductive health,['10.1186/s12978-019-0744-3'] 311,31751183,Right-to-left shunts in lowlanders with COPD traveling to altitude: a randomized controlled trial with dexamethasone.,"Right-to-left shunts (RLS) are prevalent in patients with chronic obstructive pulmonary disease (COPD) and might exaggerate oxygen desaturation, especially at altitude. The aim of this study was to describe the prevalence of RLS in patients with COPD traveling to altitude and the effect of preventive dexamethasone. Lowlanders with COPD [Global Initiative for Chronic Obstructive Lung Disease (GOLD) grades 1-2, oxygen saturation assessed by pulse oximetry ( S p O 2 ) >92%] were randomized to dexamethasone (4 mg bid) or placebo starting 24 h before ascent from 760 m and while staying at 3,100 m for 48 h. Saline-contrast echocardiography was performed at 760 m and after the first night at altitude. Of 87 patients (81 men, 6 women; mean ± SD age 57 ± 9 yr, forced expiratory volume in 1 s 89 ± 22% pred, S p O 2 95 ± 2%), 39 were assigned to placebo and 48 to dexamethasone. In the placebo group, 19 patients (49%) had RLS, of which 13 were intracardiac. In the dexamethasone group 23 patients (48%) had RLS, of which 11 were intracardiac ( P = 1.0 vs. dexamethasone). Eleven patients receiving placebo and 13 receiving dexamethasone developed new RLS at altitude ( P = 0.011 for both changes, P = 0.411 between groups). RLS prevalence at 3,100 m was 30 (77%) in the placebo and 36 (75%) in the dexamethasone group ( P = not significant). Development of RLS at altitude could be predicted at lowland by a higher resting pulmonary artery pressure, a lower arterial partial pressure of oxygen, and a greater oxygen desaturation during exercise but not by treatment allocation. Almost half of lowlanders with COPD revealed RLS near sea level, and this proportion significantly increased to about three-fourths when traveling to 3,100 m irrespective of dexamethasone prophylaxis. NEW & NOTEWORTHY The prevalence of intracardiac and intrapulmonary right-to-left shunts (RLS) at altitude in patients with chronic obstructive pulmonary disease (COPD) has not been studied so far. In a large cohort of patients with moderate COPD, our randomized trial showed that the prevalence of RLS increased from 48% at 760 m to 75% at 3,100 m in patients taking placebo. Preventive treatment with dexamethasone did not significantly reduce the altitude-induced recruitment of RLS. Development of RLS at 3,100 m could be predicted at 760 m by a higher resting pulmonary artery pressure and arterial partial pressure of oxygen and a more pronounced oxygen desaturation during exercise. Dexamethasone did not modify the RLS prevalence at 3,100 m.",2020,"11 patients receiving placebo and 13 dexamethasone developed new RLS at altitude (p=0.011 both changes, p=0.411 between groups).","['patients with COPD traveling to altitude', '87 patients (81 men, mean ±SD age 57 ±9 y, FEV 1 89 ±22 % pred, SpO 2 95 ±2 %) 39 were assigned to', 'Lowlanders with COPD, GOLD 1-2, oxygen saturation (SpO 2 ) >92', 'lowlanders with COPD traveling to altitude ', '11 patients receiving', 'patients with chronic obstructive pulmonary disease (COPD']","['Right-to-left shunts', 'Right-to-left shunts (RLS', 'placebo', 'dexamethasone', 'placebo, starting 24 h before ascent from 760 m and while staying at 3,100 m for 48 h. Saline contrast echocardiography']","['RLS prevalence', 'RLS near sea level', 'new RLS at altitude', 'oxygen desaturation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0040802', 'cui_str': 'Travel (event)'}, {'cui': 'C0002349', 'cui_str': 'Altitude'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}]","[{'cui': 'C0445232', 'cui_str': 'Right to left (qualifier value)'}, {'cui': 'C1442858', 'cui_str': 'Surgical fistula'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0013518', 'cui_str': 'Echocardiography, Contrast'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0036493', 'cui_str': 'Sea (environment)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0002349', 'cui_str': 'Altitude'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]",81.0,0.576509,"11 patients receiving placebo and 13 dexamethasone developed new RLS at altitude (p=0.011 both changes, p=0.411 between groups).","[{'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Lichtblau', 'Affiliation': 'Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Furian', 'Affiliation': 'Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Sayaka S', 'Initials': 'SS', 'LastName': 'Aeschbacher', 'Affiliation': 'Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Bisang', 'Affiliation': 'Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Ulan', 'Initials': 'U', 'LastName': 'Sheraliev', 'Affiliation': 'National Center for Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Maamed', 'Initials': 'M', 'LastName': 'Mademilov', 'Affiliation': 'National Center for Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Nuriddin H', 'Initials': 'NH', 'LastName': 'Marazhapov', 'Affiliation': 'National Center for Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Ulrich', 'Affiliation': 'Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Talant', 'Initials': 'T', 'LastName': 'Sooronbaev', 'Affiliation': 'National Center for Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Konrad E', 'Initials': 'KE', 'LastName': 'Bloch', 'Affiliation': 'Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Ulrich', 'Affiliation': 'Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich, Zurich, Switzerland.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00548.2019'] 312,31294619,Immunomodulatory effects of topical diphencyprone for the treatment of acute urban cutaneous leishmaniasis.,"BACKGROUND AND OBJECTIVE Efficacious and safe treatments are lacking for cutaneous leishmaniasis (CL). This study investigates the efficacy of adding diphencyprone immunotherapy to conventional meglumine antimoniate (MA) treatment for acute urban CL. METHODS This randomized controlled pilot study included 46 patients with acute CL. They were randomly allocated to receive either combination of diphencyprone immunotherapy with intralesional MA (intervention; N  = 23) or intralesional MA alone (control; N  = 23) weekly. The size and duration of lesions were measured at the baseline and after that at 4th, 8th, 12th, and 24th weeks. Data were analyzed in SPSS and p  < .05 was considered significant. RESULTS The groups showed no significant difference in duration of lesions, but number of injections was significantly higher in the control group compared with the intervention group ( p  < .001). Size and induration of lesions was significantly reduced in both groups during the course of study ( p  < .001). The intervention group showed significantly lower induration of lesions in 4th, 8th, and 12th week compared with controls ( p  < .05). CONCLUSION Combination of diphencyprone with MA resulted in earlier resolution of acute CL lesions with a relatively acceptable rate of adverse effects, compared with intralesional MA alone.",2021,Size and induration of lesions was significantly reduced in both groups during the course of study ( p  < .001).,"['acute urban cutaneous leishmaniasis', '46 patients with acute CL', 'acute urban CL']","['topical diphencyprone', 'conventional meglumine antimoniate (MA', 'intralesional MA', 'diphencyprone with MA', 'diphencyprone immunotherapy', 'diphencyprone immunotherapy with intralesional MA (intervention; N \u2009=\u200923) or intralesional MA alone (control; N \u2009=\u200923) weekly']","['Size and induration of lesions', 'earlier resolution of acute CL lesions', 'lower induration of lesions', 'duration of lesions, but number of injections', 'size and duration of lesions']","[{'cui': 'C0086541', 'cui_str': 'Oriental Sore'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0058379', 'cui_str': 'diphenylcyclopropenone'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1096768', 'cui_str': 'meglumine antimoniate'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0332534', 'cui_str': 'Induration (morphologic abnormality)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]",46.0,0.074675,Size and induration of lesions was significantly reduced in both groups during the course of study ( p  < .001).,"[{'ForeName': 'Yalda', 'Initials': 'Y', 'LastName': 'Nahidi', 'Affiliation': 'Cutaneous Leishmaniasis Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Mashayekhi Goyonlo', 'Affiliation': 'Cutaneous Leishmaniasis Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Pouran', 'Initials': 'P', 'LastName': 'Layegh', 'Affiliation': 'Cutaneous Leishmaniasis Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Faezeh', 'Initials': 'F', 'LastName': 'Taghavi', 'Affiliation': 'Cutaneous Leishmaniasis Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Najaf Najafi', 'Affiliation': 'Clinical Research Unit, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",The Journal of dermatological treatment,['10.1080/09546634.2019.1642997'] 313,31256250,Accelerated Skills Acquisition Protocol (ASAP) in optimizing robotic surgical simulation training: a prospective randomized study.,"PURPOSE To assess the efficacy of an accelerated proficiency-based training protocol in robotic simulation practice in delivering durable proficiency compared to conventional training methods. METHODS Novice medical students (n = 16) were randomized into either the accelerated skills acquisition protocol (ASAP) or conventional training protocol (CTP). Subjects were trained to proficiency on the da Vinci Skills Simulator (dVSS) by an expert trainer. Differences in the repetitions required to achieve proficiency in two simple and two complex virtual reality (VR) training tasks were assessed as the primary outcome measure. Transfer of the acquired skills to two other non-practiced tasks was assessed immediately and prospectively followed through to 3, 6 and 12 months in the two groups. Retention of the practiced tasks was assessed along the same timeframe. RESULTS Subjects in the ASAP group acquired proficiency significantly faster in three of the four training tasks: camera control (p = 0.0002), suture sponge (p < 0.0001), ring walk3 (p < 0.0001), and peg board (p = 0.6936). When assessing transfer of skills, there were no significant differences between the two groups: Ring rail 3 (p = 0.6807) and Tubes (p = 0.2240). When assessing retention of skills at 3, 6 and 12 months, for all 6 tasks, no significant differences were seen between the ASAP and CTP groups. CONCLUSION ASAP is proven to be an efficient approach for delivering proficiency in robotic VR simulation training. The results are durable when compared to conventional simulation training methods. The findings may have significant implications in the design of robotic VR simulation curricula.",2020,"When assessing retention of skills at 3, 6 and 12 months, for all 6 tasks, no significant differences were seen between the ASAP and CTP groups. ",['Novice medical students (n\u2009=\u200916'],"['accelerated proficiency-based training protocol', 'Accelerated Skills Acquisition Protocol (ASAP', 'accelerated skills acquisition protocol (ASAP) or conventional training protocol (CTP', 'da Vinci Skills Simulator (dVSS) by an expert trainer']",['suture sponge'],"[{'cui': 'C0038495', 'cui_str': 'Students, Medical'}]","[{'cui': 'C0521110', 'cui_str': 'Accelerated (contextual qualifier) (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0010734', 'cui_str': 'CRPPP'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C1705741', 'cui_str': 'Sponge (basic dose form)'}]",16.0,0.0239299,"When assessing retention of skills at 3, 6 and 12 months, for all 6 tasks, no significant differences were seen between the ASAP and CTP groups. ","[{'ForeName': 'Pratik M S', 'Initials': 'PMS', 'LastName': 'Gurung', 'Affiliation': 'Department of Urology, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Campbell', 'Affiliation': 'Department of Urology, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Bokai', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Jean V', 'Initials': 'JV', 'LastName': 'Joseph', 'Affiliation': 'Department of Urology, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Ahmed E', 'Initials': 'AE', 'LastName': 'Ghazi', 'Affiliation': 'Department of Urology, University of Rochester Medical Center, Rochester, NY, USA. ahmed_ghazi@urmc.rochester.edu.'}]",World journal of urology,['10.1007/s00345-019-02858-9'] 314,31256765,'Placement budgets' for supported employment: impact on employment rates in a multicentre randomised controlled trial.,"BACKGROUND The most effective rehabilitation model for job (re-)entry of people with mental illness is supported employment. A barrier to introducing supported employment into standard care is its temporally unlimited provision, which conflicts with health and social legislation in many European countries. AIMS To test the impact of different 'placement budgets', i.e. a predefined maximum time budget for job seeking until take-up of competitive employment. METHOD Participants (116) were randomly assigned to 25 h, 40 h or 55 h placement budgets in an intent-to-treat analysis. We applied the individual placement and support model over 24 months, following participants for 36 months. Primary outcome was employment in the labour market for at least 3 months. RESULTS The proportion of participants obtaining competitive employment was 55.1% in the 25 h group, 37.8% in the 40 h group and 35.8% in the 55 h group. In a Cox regression analysis, time to employment was slightly lower in the 25 h group relative to the 40 h (hazard ratio 1.78, 95% CI 0.88-3.57, P = 0.107) and 55 h groups (hazard ratio 1.74, 95% CI 0.86-3.49, P = 0.122), but this was not statistically significant. The vast majority of all participants who found a job did so within the first 12 months (80.4%). CONCLUSION A restricted time budget for job finding and placement does not affect the rate of successful employment. In accordance with legislation, a restriction of care provision seems justified and enhances the chances of supported employment being introduced in statutory services.",2020,"The vast majority of all participants who found a job did so within the first 12 months (80.4%). ","['job (re-)entry of people with mental illness', 'Participants (116']",[],"['proportion of participants obtaining competitive employment', 'rate of successful employment', 'time to employment', 'employment in the labour market for at least 3 months']","[{'cui': 'C0028811', 'cui_str': 'Occupations'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}]",[],"[{'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C1318228', 'cui_str': 'Market (environment)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",116.0,0.201813,"The vast majority of all participants who found a job did so within the first 12 months (80.4%). ","[{'ForeName': 'Wulf', 'Initials': 'W', 'LastName': 'Rössler', 'Affiliation': 'Professor, Department of Psychiatry, Psychotherapy and Psychosomatics, University of Zurich, Switzerland; Institute of Psychiatry, Laboratory of Neuroscience (LIM 27), University of Sao Paulo, Brazil; and Department of Psychiatry and Psychotherapy, Campus Charité Mitte, Charité - Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Wolfram', 'Initials': 'W', 'LastName': 'Kawohl', 'Affiliation': 'Senior Consultant, Psychiatrische Dienste Aargau AG, Klinik für Psychiatrie und Psychotherapie, Switzerland.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Nordt', 'Affiliation': 'Senior Researcher, Department of Psychiatry, Psychotherapy and Psychosomatics, University of Zurich, Switzerland.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Haker', 'Affiliation': 'Senior Researcher, Translational Neuromodeling Unit, Institute for Biomedical Engineering, University of Zurich and ETH Zurich, Switzerland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rüsch', 'Affiliation': 'Professor, Section of Public Mental Health, University of Ulm, Germany.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Hengartner', 'Affiliation': 'Senior Lecturer, Department of Applied Psychology, Zurich University of Applied Sciences, Switzerland.'}]",The British journal of psychiatry : the journal of mental science,['10.1192/bjp.2019.154'] 315,31878810,Efficacy of Recombinant Human Epidermal Growth Factor (Regen-D 150) in Healing Diabetic Foot Ulcers: A Hospital-Based Randomized Controlled Trial.,"To validate the efficacy of recombinant human epidermal growth factor (hEGH) in healing diabetic foot ulcers (DFUs) at biochemical and molecular levels. A total of 50 noninfected DFU subjects were recruited for the study and divided into 2 groups based on the treatment application on the subjects. Group 1: DFU subjects treated with hEGH gel-based product called Regen-D 150 (n = 27) and group 2: DFU subjects treated with alternative placebo as the control group (n = 23). Patients were observed for 30 days and punch biopsy was taken at days 0 and 14. Histologic analysis was done to study the matrix alignment, cellular infiltration, and differentiation of epithelial layers. Biochemical analysis was done to quantitatively estimate the amount of collagen and proteoglycans regenerated in the wound area. Complete healing of ulcers was observed in 21 (78%) subjects in group 1, whereas only 12 (52%) subjects among group 2 reported of complete healing of ulcer after completion of the study period of 30 days. Collagen and fibroblasts were significantly developed in group 1 when observed in the follow-up samples. Healing time of the wound among the group 1 subjects was significantly less than the group 2 subjects (45 ± 12 vs 72 ± 18 days, P < .0001) and even showed a better blood glucose level. Early and regular application of the hEGH on DFUs will lead to prevention of leg amputations and would serve to act as a major treatment therapy for healing of chronic wounds.",2020,Collagen and fibroblasts were significantly developed in group 1 when observed in the follow-up samples.,"['Healing Diabetic Foot Ulcers', 'healing diabetic foot ulcers (DFUs', '50 noninfected DFU subjects']","['hEGH gel-based product called Regen-D 150', 'Recombinant Human Epidermal Growth Factor (Regen-D 150', 'recombinant human epidermal growth factor (hEGH', 'hEGH', 'DFU subjects treated with alternative placebo']","['blood glucose level', 'complete healing of ulcer', 'Healing time', 'Collagen and fibroblasts', 'Complete healing of ulcers']","[{'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer (disorder)'}]","[{'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1509244', 'cui_str': 'nepidermin'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0016030', 'cui_str': 'Fibroblasts'}]",,0.0185808,Collagen and fibroblasts were significantly developed in group 1 when observed in the follow-up samples.,"[{'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Viswanathan', 'Affiliation': 'MV Hospital for Diabetes and Prof. M. Viswanathan Diabetes Research Centre, WHO Collaborating Centre for Research, Education and Training in Diabetes & IDF Centre for Excellence in Diabetes Care, Chennai, India.'}, {'ForeName': 'Udyama', 'Initials': 'U', 'LastName': 'Juttada', 'Affiliation': 'MV Hospital for Diabetes and Prof. M. Viswanathan Diabetes Research Centre, WHO Collaborating Centre for Research, Education and Training in Diabetes & IDF Centre for Excellence in Diabetes Care, Chennai, India.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Babu', 'Affiliation': 'Central Leather Research Institute (CLRI), Chennai, India.'}]",The international journal of lower extremity wounds,['10.1177/1534734619892791'] 316,31845139,"Effect on Bleeding Prevention of an Intravenous Proton Pump Inhibitor During the Fasting Period After Endoscopic Submucosal Dissection: a Prospective, Randomized, Double-Blind, Placebo-Controlled Trial.","BACKGROUND No consensus has been achieved on optimal perioperative strategies for patients undergoing endoscopic submucosal dissection (ESD). The aim of this study was to investigate the effects of an intravenous (IV) proton pump inhibitor (PPI) given during the fasting period after ESD on delayed bleeding following ESD. METHODS This study was designed as a prospective, randomized, double-blind, placebo-controlled trial in a single center. A total of 235 patients who underwent ESD for adenoma and early gastric cancer between March 2016 and September 2018 were randomized into a PPI group and placebo group. Patients were administrated intravenous pantoprazole 40 mg daily (PPI group) or placebo (placebo group) during the fasting period 48 h after ESD (from the day of ESD to the following day, 48 h). After oral feeding (48 h after ESD), oral PPI was given to both groups for 8 weeks. RESULTS Among 235 patients in the intention-to-treat (ITT) and 195 in the per-protocol (PP) analysis, there was no significant difference between the PPI and control groups in major bleeding (PPI vs. placebo; 3.3% vs. 1.7%, p = 0.27) or minor bleeding (PPI vs. placebo; 7.6% vs. 4.3%, p = 0.41) after ESD. There was no significant difference in age (p = 0.28), histology (p = 0.75), tumor size (p = 0.48), or procedure time (p = 0.49) between the two groups. The only independent risk factor for major delayed bleeding was the combined use of aspirin and antiplatelet agent (OR; 12.25, 95% CI; 1.06-141.19, p = 0.04). CONCLUSIONS Administration of routine IV PPI during the fasting period 48 h after ESD does not reduce delayed post-ESD bleeding.",2020,"There was no significant difference in age (p = 0.28), histology (p = 0.75), tumor size (p = 0.48), or procedure time (p = 0.49) between the two groups.","['235 patients in the intention-to-treat (ITT) and 195 in the per-protocol (PP) analysis', '235 patients who underwent ESD for adenoma and early gastric cancer between March 2016 and September 2018', 'patients undergoing endoscopic submucosal dissection (ESD']","['intravenous (IV) proton pump inhibitor (PPI', 'Placebo', 'Intravenous Proton Pump Inhibitor', 'PPI group and placebo', 'placebo', 'Endoscopic Submucosal Dissection', 'pantoprazole 40 mg daily (PPI group) or placebo (placebo', 'aspirin']","['tumor size', 'procedure time', 'minor bleeding', 'risk factor for major delayed bleeding', 'major bleeding', 'Bleeding Prevention', 'delayed post-ESD bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0349530', 'cui_str': 'Early gastric cancer (disorder)'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}, {'cui': 'C1126048', 'cui_str': 'pantoprazole 40 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]",235.0,0.377994,"There was no significant difference in age (p = 0.28), histology (p = 0.75), tumor size (p = 0.48), or procedure time (p = 0.49) between the two groups.","[{'ForeName': 'Jai Hoon', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Hanyang University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Youn Jeong', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Division of Infectious disease, Department of Internal medicine, College of Medicine, The Catholic University of Korea, Seoul, South Korea.'}, {'ForeName': 'Kang Nyeong', 'Initials': 'KN', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Hanyang University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Dae Won', 'Initials': 'DW', 'LastName': 'Jun', 'Affiliation': 'Department of Internal Medicine, Hanyang University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Dong Hee', 'Initials': 'DH', 'LastName': 'Koh', 'Affiliation': 'Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong-si, South Korea.'}, {'ForeName': 'Hang Lak', 'Initials': 'HL', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Hanyang University College of Medicine, Seoul, South Korea. alwayshang@hanyang.ac.kr.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-019-04466-9'] 317,31866839,A MEG Study of Acute Arbaclofen (STX-209) Administration.,"Several electrophysiological parameters, including the auditory evoked response component M50/M100 latencies and the phase synchrony of transient and steady-state gamma-band oscillations have been implicated as atypical (to various extents) in autism spectrum disorder (ASD). Furthermore, some hypotheses suggest that an underlying neurobiological mechanism for these observations might be atypical local circuit function indexed by atypical levels of inhibitory neurotransmitter, GABA. This study was a randomized, placebo-controlled, double-blind, escalating-dose, acute investigation conducted in 25 14-18 year-old adolescents with ASD. The study assessed the sensitivity of magnetoencephalography (MEG) and MEGAPRESS ""GABA"" magnetic resonance spectroscopy (MRS) to monitor dose-dependent acute effects, as well as seeking to define properties of the pre-drug ""baseline"" electrophysiological and GABA signatures that might predict responsiveness to the GABA-B agonist, arbaclofen (STX-209). Overall, GABA levels and gamma-band oscillatory activity showed no acute changes at either low (15 mg) or high (30 mg) dose. Evoked M50 response latency measures tended to shorten (normalize), but there was heterogeneity across the group in M50 latency response, with only a subset of participants ( n = 6) showing significant M50 latency shortening, and only at the 15 mg dose. Findings thus suggest that MEG M50 latency measures show acute effects of arbaclofen administration in select individuals, perhaps reflecting effective target engagement. Whether these subjects have a greater trend towards clinical benefit remains to be established. Finally, findings also provide preliminary support for the use of objective electrophysiological measures upon which to base inclusion for optimal enrichment of populations to be included in full-scale clinical trials of arbaclofen.",2019,"Several electrophysiological parameters, including the auditory evoked response component M50/M100 latencies and the phase synchrony of transient and steady-state gamma-band oscillations have been implicated as atypical (to various extents) in autism spectrum disorder (ASD).","['25 14-18 year-old adolescents with ASD', 'autism spectrum disorder (ASD']","['placebo', 'magnetoencephalography (MEG) and MEGAPRESS ""GABA"" magnetic resonance spectroscopy (MRS']","['Overall, GABA levels and gamma-band oscillatory activity', 'Evoked M50 response latency measures']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0024489', 'cui_str': 'Magnetoencephalography'}, {'cui': 'C0016904', 'cui_str': 'gamma-Aminobutyric Acid'}, {'cui': 'C0024487', 'cui_str': 'MR Spectroscopy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0016904', 'cui_str': 'gamma-Aminobutyric Acid'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1552644', 'cui_str': 'Greek letter gamma'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.136331,"Several electrophysiological parameters, including the auditory evoked response component M50/M100 latencies and the phase synchrony of transient and steady-state gamma-band oscillations have been implicated as atypical (to various extents) in autism spectrum disorder (ASD).","[{'ForeName': 'Timothy P L', 'Initials': 'TPL', 'LastName': 'Roberts', 'Affiliation': ""Lurie Family Foundations MEG Imaging Center, Department of Radiology, The Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Bloy', 'Affiliation': ""Lurie Family Foundations MEG Imaging Center, Department of Radiology, The Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Blaskey', 'Affiliation': ""Lurie Family Foundations MEG Imaging Center, Department of Radiology, The Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Kuschner', 'Affiliation': ""Lurie Family Foundations MEG Imaging Center, Department of Radiology, The Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Gaetz', 'Affiliation': ""Lurie Family Foundations MEG Imaging Center, Department of Radiology, The Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}, {'ForeName': 'Ayesha', 'Initials': 'A', 'LastName': 'Anwar', 'Affiliation': ""Lurie Family Foundations MEG Imaging Center, Department of Radiology, The Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Ku', 'Affiliation': ""Lurie Family Foundations MEG Imaging Center, Department of Radiology, The Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Dipiero', 'Affiliation': ""Lurie Family Foundations MEG Imaging Center, Department of Radiology, The Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Bennett', 'Affiliation': ""Department of Pediatrics, The Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}, {'ForeName': 'J Christopher', 'Initials': 'JC', 'LastName': 'Edgar', 'Affiliation': ""Lurie Family Foundations MEG Imaging Center, Department of Radiology, The Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}]",Frontiers in integrative neuroscience,['10.3389/fnint.2019.00069'] 318,31305232,Physical therapists' experiences of learning and delivering a complex behavioral medicine intervention to adolescents with pain.,"The objective was to study physical therapists' (PTs') experiences of learning and delivering a complex intervention, a tailored behavioral medicine treatment (BMT) targeting adolescents with pain in primary care. Method : An explorative study with qualitative approach, using content analysis. Three primary care PTs delivering the treatments in a randomized controlled study were interviewed regarding their views on the BMT. Results : The participating PTs considered learning about and delivering the BMT as challenging but rewarding. The biopsychosocial approach, tailoring of the treatment and dialogues with parents were identified as key aspects of the BMT program. The process of formulating a functional behavioral analysis was perceived as strenuous. The supervision of the PTs throughout the study was regarded as crucial and necessary for learning about and providing tailored BMT. Conclusion : Learning about and delivering BMT targeting adolescents with persistent pain is fruitful but laborious and demanding according to three PTs experienced with treatment of pediatric pain in primary care. Extensive education and long periods of supervision seem to be crucial for success and safe delivery according to protocol.",2021,Learning about and delivering BMT targeting adolescents with persistent pain is fruitful but laborious and demanding according to three PTs experienced with treatment of pediatric pain in primary care.,"['adolescents with pain', 'adolescents with pain in primary care']","['learning and delivering a complex behavioral medicine intervention', 'learning and delivering a complex intervention, a tailored behavioral medicine treatment (BMT']",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0004937', 'cui_str': 'Behavioral Medicine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],,0.0303647,Learning about and delivering BMT targeting adolescents with persistent pain is fruitful but laborious and demanding according to three PTs experienced with treatment of pediatric pain in primary care.,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Frygner-Holm', 'Affiliation': 'Department of Neuroscience, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Pernilla', 'Initials': 'P', 'LastName': 'Åsenlöf', 'Affiliation': 'Department of Neuroscience, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Gustaf', 'Initials': 'G', 'LastName': 'Ljungman', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, Akademiska Sjukhuset, Uppsala, Sweden.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Söderlund', 'Affiliation': 'School of Health Care and Social Welfare, Mälardalen University, Västerås, Sweden.'}]",Physiotherapy theory and practice,['10.1080/09593985.2019.1639232'] 319,31280694,"Culture-sensitive and standard pain neuroscience education improves pain, disability, and pain cognitions in first-generation Turkish migrants with chronic low back pain: a pilot randomized controlled trial.","Purpose : To compare the effectiveness of culture-sensitive and standard pain neuroscience education (PNE) on pain knowledge, pain intensity, disability, and pain cognitions in first-generation Turkish migrants with chronic low back pain (CLBP). Methods : Twenty-nine Turkish first-generation migrants with CLBP were randomly assigned to the culture-sensitive (n = 15) or standard PNE (n = 14) groups. Primary (pain knowledge, pain intensity, and disability) and secondary outcomes (pain beliefs, catastrophization, and fear of movement) were evaluated at baseline, immediately after the second session of PNE (week 1), and after 4 weeks. Results : There was a significant main effect of time in pain knowledge ( p < .001), pain intensity ( p = .03), disability ( p = .002), organic and psychological pain beliefs ( p = .002, p = .01), catastrophization ( p = .002), and fear of movement ( p = .02). However, no significant difference was found between groups in terms of all outcome measures ( p > .05). Conclusions : Both PNE programs resulted in improvements in knowledge of pain, pain intensity, perceived disability, and pain cognitions. Nevertheless, the superiority of the culture-sensitive PNE approach could not be proved. Therefore, maybe migrants who are living in the host country for longer length of time do not need culturally adapted therapies due to cultural integration, while these adaptations might be essential for the recent migrants or the autochthonous population in Turkey. Further research is required to investigate the effects of culture-sensitive PNE alone or in combination with physiotherapy interventions in recent migrants or Turkish natives with CLBP.",2021,"There was a significant main effect of time in pain knowledge ( p < .001), pain intensity ( p = .03), disability ( p = .002), organic and psychological pain beliefs ( p = .002, ","['first-generation Turkish migrants with chronic low back pain (CLBP', 'Twenty-nine Turkish first-generation migrants with CLBP', 'chronic low back pain']","['culture-sensitive (n\xa0=\xa015) or standard PNE', 'Culture-sensitive and standard pain neuroscience education', 'culture-sensitive and standard pain neuroscience education (PNE', 'culture-sensitive PNE alone or in combination with physiotherapy interventions']","['pain knowledge, pain intensity, disability, and pain cognitions', 'catastrophization', 'knowledge of pain, pain intensity, perceived disability, and pain cognitions', 'fear of movement', 'Primary (pain knowledge, pain intensity, and disability) and secondary outcomes (pain beliefs, catastrophization, and fear of movement', 'pain intensity', 'organic and psychological pain beliefs', 'disability', 'time in pain knowledge', 'pain, disability, and pain cognitions']","[{'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0554967', 'cui_str': 'Turkish (NMO) (ethnic group)'}, {'cui': 'C0026093', 'cui_str': 'Migrants'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}]","[{'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0563150', 'cui_str': 'Catastrophizing'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0751115,"There was a significant main effect of time in pain knowledge ( p < .001), pain intensity ( p = .03), disability ( p = .002), organic and psychological pain beliefs ( p = .002, ","[{'ForeName': 'Ceren', 'Initials': 'C', 'LastName': 'Orhan', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Dorine', 'Initials': 'D', 'LastName': 'Lenoir', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Ghent University, Ghent, Belgium.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Favoreel', 'Affiliation': 'Department of Physiotherapy, De Sleep Health Center, Ghent, Belgium.'}, {'ForeName': 'Eveline', 'Initials': 'E', 'LastName': 'Van Looveren', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Vesile', 'Initials': 'V', 'LastName': 'Yildiz Kabak', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Naziru Bashir', 'Initials': 'NB', 'LastName': 'Mukhtar', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Cagnie', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Meeus', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Ghent University, Ghent, Belgium.'}]",Physiotherapy theory and practice,['10.1080/09593985.2019.1639231'] 320,31218531,Effects of computerized cognitive training as add-on treatment to stimulants in ADHD: a pilot fMRI study.,"The neurofunctional effects of Cognitive training (CT) are poorly understood. Our main objective was to assess fMRI brain activation patterns in children with ADHD who received CT as an add-on treatment to stimulant medication. We included twenty children with ADHD from a clinical trial of stimulant medication and CT (10 in medication + CT and 10 in medication + non-active training). Between-group differences were assessed in performance and in brain activation during 3 fMRI paradigms of working memory (N-back: 0-back, 1-back, 2-back, 3-back), sustained attention (Sustained Attention Task - SAT: 2 s, 5 s and 8 s delays) and inhibitory control (Go/No-Go). We found significant group x time x condition interactions in working memory (WM) and sustained attention on brain activation. In N-back, decreases were observed in the BOLD signal change from baseline to endpoint with increasing WM load in the right insula, right putamen, left thalamus and left pallidum in the CT compared to the non-active group; in SAT - increases in the BOLD signal change from baseline to endpoint with increasing delays were observed in bilateral precuneus, right insula, bilateral associative visual cortex and angular gyrus, right middle temporal, precentral, postcentral, superior frontal and middle frontal gyri in the CT compared to the non-active group. CT in ADHD was associated with changes in activation in task-relevant parietal and striato-limbic regions of sustained attention and working memory. Changes in brain activity may precede behavioral performance modifications in working memory and sustained attention, but not in inhibitory control.",2020,CT in ADHD was associated with changes in activation in task-relevant parietal and striato-limbic regions of sustained attention and working memory.,"['children with ADHD who received', 'ADHD', 'twenty children with ADHD from a clinical trial of stimulant medication and CT (10 in medication + CT and 10 in medication + non-active training']","['CT', 'computerized cognitive training', 'Cognitive training (CT', 'inhibitory control (Go']","['working memory (N-back: 0-back, 1-back, 2-back, 3-back), sustained attention (Sustained Attention Task - SAT: 2\xa0s, 5\xa0s and', 'fMRI brain activation patterns', 'working memory (WM) and sustained attention on brain activation', 'performance and in brain activation', 'BOLD signal change', 'bilateral precuneus, right insula, bilateral associative visual cortex and angular gyrus, right middle temporal, precentral, postcentral, superior frontal and middle frontal gyri']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention, function (observable entity)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0021640', 'cui_str': 'Insula of Reil'}, {'cui': 'C0042817', 'cui_str': 'Visual Cortex'}, {'cui': 'C0152305', 'cui_str': 'Prelunate Gyrus'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0152297', 'cui_str': 'Middle frontal gyrus'}]",20.0,0.0320557,CT in ADHD was associated with changes in activation in task-relevant parietal and striato-limbic regions of sustained attention and working memory.,"[{'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'de Oliveira Rosa', 'Affiliation': 'Postgraduate Program in Psychiatry and Behavioral Sciences, Federal University of Rio Grande do Sul (UFRGS), Porto Alegre, Brazil. virginia.orosa@gmail.com.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Rosa Franco', 'Affiliation': 'Center for Biomedical Imaging and Neuromodulation, The Nathan S. Kline Institute for Psychiatric Research, Orangeburg, NY, USA.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Abrahão Salum Júnior', 'Affiliation': 'ADHD Outpatient Program, Hospital de Clinicas de Porto Alegre, Department of Psychiatry, Federal University of Rio Grande do Sul, Serviço de Psiquiatria. Ramiro Barcelos, 2350. Bairro Santa Cecília, Porto Alegre, RS, CEP: 90035-903, Brazil.'}, {'ForeName': 'Carlos Renato', 'Initials': 'CR', 'LastName': 'Moreira-Maia', 'Affiliation': 'ADHD Outpatient Program, Hospital de Clinicas de Porto Alegre, Department of Psychiatry, Federal University of Rio Grande do Sul, Serviço de Psiquiatria. Ramiro Barcelos, 2350. Bairro Santa Cecília, Porto Alegre, RS, CEP: 90035-903, Brazil.'}, {'ForeName': 'Flávia', 'Initials': 'F', 'LastName': 'Wagner', 'Affiliation': 'ADHD Outpatient Program, Hospital de Clinicas de Porto Alegre, Department of Psychiatry, Federal University of Rio Grande do Sul, Serviço de Psiquiatria. Ramiro Barcelos, 2350. Bairro Santa Cecília, Porto Alegre, RS, CEP: 90035-903, Brazil.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Simioni', 'Affiliation': 'Postgraduate Program in Psychiatry and Behavioral Sciences, Federal University of Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'de Fraga Bassotto', 'Affiliation': 'ADHD Outpatient Program, Hospital de Clinicas de Porto Alegre, Department of Psychiatry, Federal University of Rio Grande do Sul, Serviço de Psiquiatria. Ramiro Barcelos, 2350. Bairro Santa Cecília, Porto Alegre, RS, CEP: 90035-903, Brazil.'}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': 'R Moritz', 'Affiliation': 'ADHD Outpatient Program, Hospital de Clinicas de Porto Alegre, Department of Psychiatry, Federal University of Rio Grande do Sul, Serviço de Psiquiatria. Ramiro Barcelos, 2350. Bairro Santa Cecília, Porto Alegre, RS, CEP: 90035-903, Brazil.'}, {'ForeName': 'Cristiano', 'Initials': 'C', 'LastName': 'Schaffer Aguzzoli', 'Affiliation': 'Hospital São Lucas, Pontifical Catholic University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Buchweitz', 'Affiliation': 'BraIns, Brain Institute of Rio Grande do Sul, Pontifical Catholic University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Schmitz', 'Affiliation': 'ADHD Outpatient Program, Hospital de Clinicas de Porto Alegre, Department of Psychiatry, Federal University of Rio Grande do Sul, Serviço de Psiquiatria. Ramiro Barcelos, 2350. Bairro Santa Cecília, Porto Alegre, RS, CEP: 90035-903, Brazil.'}, {'ForeName': 'Katya', 'Initials': 'K', 'LastName': 'Rubia', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Luis Augusto', 'Initials': 'LA', 'LastName': 'Paim Rohde', 'Affiliation': 'ADHD Outpatient Program, Hospital de Clinicas de Porto Alegre, Department of Psychiatry, Federal University of Rio Grande do Sul, Serviço de Psiquiatria. Ramiro Barcelos, 2350. Bairro Santa Cecília, Porto Alegre, RS, CEP: 90035-903, Brazil.'}]",Brain imaging and behavior,['10.1007/s11682-019-00137-0'] 321,31894444,Pathways for HIV Prevention Behaviors Following a Home-Based Couples Intervention for Pregnant Women and Male Partners in Kenya.,"Pregnancy is a time of heightened HIV risk, but also a phase when a couple can prioritize family health. We conducted secondary analysis of a home-based intervention in rural Kenya to explore couple-level adherence to HIV prevention behaviors. The intervention included health education, relationship-building skills, and Couples HIV Testing and Counseling. Pregnant women were randomized to the intervention (n = 64) or standard care (n = 63) along with male partners. Of 96 couples, 82 (85.0%) were followed to 3 months postpartum, when 31.0% of couples reported perfect adherence to HIV prevention. In logistic regression, intervention condition couples had three-fold higher odds of perfect adherence (AOR = 3.07, 95% CI = 1.01-9.32). A structural equation model found the intervention had moderate effects on couple communication, large effects on couple efficacy to take action around HIV, which in turn improved HIV prevention behaviors (CFI = 0.969; TLI = 0.955; RMSEA = 0.049). Strengthening couple communication and efficacy may help prevent the spread of HIV to infants or partners around the time of pregnancy.",2020,"In logistic regression, intervention condition couples had three-fold higher odds of perfect adherence (AOR = 3.07, 95% CI = 1.01-9.32).","['rural Kenya to explore couple-level adherence to HIV prevention\xa0behaviors', 'Pregnant women', 'Pregnant Women and Male Partners in Kenya']","['Home-Based Couples Intervention', 'standard care']","['HIV prevention behaviors', 'health education, relationship-building skills, and Couples HIV Testing and Counseling']","[{'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0682323', 'cui_str': 'Companion'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0018701'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]",96.0,0.0433479,"In logistic regression, intervention condition couples had three-fold higher odds of perfect adherence (AOR = 3.07, 95% CI = 1.01-9.32).","[{'ForeName': 'Abigail M', 'Initials': 'AM', 'LastName': 'Hatcher', 'Affiliation': 'Division of HIV/AIDS, Department of Medicine, University of California, 995 Potrero Avenue, Building 80, San Francisco, CA, 94110, USA. hatchera@globalhealth.ucsf.edu.'}, {'ForeName': 'Lynae', 'Initials': 'L', 'LastName': 'Darbes', 'Affiliation': 'Department of Health Behavior and Biological Sciences, School of Nursing, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Kwena', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Pamela L', 'Initials': 'PL', 'LastName': 'Musoke', 'Affiliation': 'Department of Global Health and Obstetrics and Gynecology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Anna Joy', 'Initials': 'AJ', 'LastName': 'Rogers', 'Affiliation': 'Department of Global Health and Obstetrics and Gynecology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Owino', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Helova', 'Affiliation': 'Department of Health Care Organization and Policy, School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Jami L', 'Initials': 'JL', 'LastName': 'Anderson', 'Affiliation': 'Sparkman Center for Global Health, School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Oyaro', 'Affiliation': 'Research Care and Training Programme, Family AIDS Care and Educational Services, Kisumu, Kenya.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Bukusi', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Turan', 'Affiliation': 'Department of Health Care Organization and Policy, School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA.'}]",AIDS and behavior,['10.1007/s10461-019-02774-4'] 322,31867673,"Delivery of home-based post-partum contraception in rural Guatemalan women: feasibility, recruitment and retention in a cluster-randomized trial.","BACKGROUND Few cluster-randomized trials have been performed in rural Guatemala. Our objective was to describe the feasibility, recruitment and retention in our cluster-randomized trial. METHODS In our cluster-randomized trial, a range of contraceptives were brought to mothers' homes in rural Guatemala. RESULTS Of 173 women approached, 33 were excluded. Of the 140 eligible women, 127 (91%) consented to participate. Of the 87 women who should have been assessed for the primary outcome, three were lost to follow-up, which represents a retention rate of 97%. CONCLUSIONS Nurses who are both clinical providers and study staff can feasibly conduct research, which leads to high enrollment and retention rates.",2019,"In our cluster-randomized trial, a range of contraceptives were brought to mothers' homes in rural Guatemala. ","['rural Guatemalan women', ""mothers' homes in rural Guatemala"", '87 women who should have been assessed for the primary outcome', 'Of 173 women approached, 33 were excluded', '140 eligible women, 127 (91%) consented to participate']",['home-based post-partum contraception'],['retention rate'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0700589', 'cui_str': 'Fertility Control'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}]",173.0,0.401071,"In our cluster-randomized trial, a range of contraceptives were brought to mothers' homes in rural Guatemala. ","[{'ForeName': 'Margo S', 'Initials': 'MS', 'LastName': 'Harrison', 'Affiliation': 'University of Colorado, Anschutz Medical Campus, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Room 4211, Aurora, CO 80045, USA.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Bunge-Montes', 'Affiliation': 'Fundación para la Salud Integral de los Guatemaltecos, Quetzaltenango, Guatemala (FSIG), Calzada Roosevelt 6-25 zona 11 P.O.B 1188, Guatemala City.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Rivera', 'Affiliation': 'Fundación para la Salud Integral de los Guatemaltecos, Quetzaltenango, Guatemala (FSIG), Calzada Roosevelt 6-25 zona 11 P.O.B 1188, Guatemala City.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Jimenez-Zambrano', 'Affiliation': 'University of Colorado, Anschutz Medical Campus, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Room 4211, Aurora, CO 80045, USA.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Heinrichs', 'Affiliation': 'Denver Health, 777 Bannock St, Denver, CO 80204, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Scarbro', 'Affiliation': 'University of Colorado, Anschutz Medical Campus, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Room 4211, Aurora, CO 80045, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Juarez-Colunga', 'Affiliation': 'University of Colorado, Anschutz Medical Campus, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Room 4211, Aurora, CO 80045, USA.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Bolanos', 'Affiliation': 'Fundación para la Salud Integral de los Guatemaltecos, Quetzaltenango, Guatemala (FSIG), Calzada Roosevelt 6-25 zona 11 P.O.B 1188, Guatemala City.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Asturias', 'Affiliation': 'University of Colorado, Anschutz Medical Campus, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Room 4211, Aurora, CO 80045, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Berman', 'Affiliation': 'University of Colorado, Anschutz Medical Campus, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Room 4211, Aurora, CO 80045, USA.'}, {'ForeName': 'Jeanelle', 'Initials': 'J', 'LastName': 'Sheeder', 'Affiliation': 'University of Colorado, Anschutz Medical Campus, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Room 4211, Aurora, CO 80045, USA.'}]",International health,['10.1093/inthealth/ihz098'] 323,31738072,Improvement in women's cardiovascular functioning during cognitive-behavioral therapy for alcohol use disorder.,"The cardiovascular system is disrupted by chronic excessive alcohol use and often impaired in individuals with an alcohol use disorder (AUD). Less is known about cardiovascular recovery when an individual receives treatment for AUD. This observational study aimed to extend the growing body of evidence for cardiovascular biomarkers and intervention targets in the treatment of AUD. We examined cardiovascular function in 92 women before and after 12 weeks of cognitive-behavioral therapy (CBT) for AUD. Participants were recruited exclusively from a randomized clinical trial comparing group versus individual CBT treatment strategies (parent study); no control group of untreated, but treatment-seeking women was available. Demographic and drinking data were obtained from the parent study. Cardiovascular data were collected as part of this separate study, prior to and following the clinical trial. Mixed-model analyses revealed multiple within-person cardiovascular changes indicative of improving health from pre- to posttreatment, including reduced heart rate and vessel stiffness as well as increased heart rate variability and baroreflex sensitivity. These significant improvements remained when extent of drinking during treatment was included in the models, suggesting that active ingredients of AUD treatment may serve to benefit physical health over and above drinking reductions. Future studies should assess the time course of cardiovascular recovery during addiction treatment and the mechanisms by which evidence-based AUD treatments may benefit physical as well as mental health. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"These significant improvements remained when extent of drinking during treatment was included in the models, suggesting that active ingredients of AUD treatment may serve to benefit physical health over and above drinking reductions.","['individuals with an alcohol use disorder (AUD', ""women's cardiovascular functioning during cognitive-behavioral therapy for alcohol use disorder"", '92 women before and after 12 weeks of cognitive-behavioral therapy (CBT) for AUD']","['individual CBT treatment strategies (parent study); no control group of untreated, but treatment-seeking women was available']","['heart rate variability and baroreflex sensitivity', 'heart rate and vessel stiffness']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0007227', 'cui_str': 'Cardiovascular Physiology'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0206162', 'cui_str': 'Reflex, Baroreceptor'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}]",2019.0,0.0455963,"These significant improvements remained when extent of drinking during treatment was included in the models, suggesting that active ingredients of AUD treatment may serve to benefit physical health over and above drinking reductions.","[{'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Buckman', 'Affiliation': 'Department of Kinesiology and Health.'}, {'ForeName': 'Bronya', 'Initials': 'B', 'LastName': 'Vaschillo', 'Affiliation': 'Department of Kinesiology and Health.'}, {'ForeName': 'Evgeny G', 'Initials': 'EG', 'LastName': 'Vaschillo', 'Affiliation': 'Department of Kinesiology and Health.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Epstein', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Tam T', 'Initials': 'TT', 'LastName': 'Nguyen-Louie', 'Affiliation': 'SDSU/UCSD Joint Doctoral Program in Clinical Psychology.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Lesnewich', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Eddie', 'Affiliation': 'Massachusetts General Hospital.'}, {'ForeName': 'Marsha E', 'Initials': 'ME', 'LastName': 'Bates', 'Affiliation': 'Department of Kinesiology and Health.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000524'] 324,31852312,"Complex Wound Healing Outcomes for Outpatients Receiving Care via Telemedicine, Home Health, or Wound Clinic: A Randomized Controlled Trial.","Use of telemedicine has expanded rapidly in recent years, yet there are few comparative studies to determine its effectiveness in wound care. To provide experimental data in the field of telemedicine with regard to wound care, a pilot project named ""Domoplaies"" was publicly funded in France in 2011. A randomized, controlled trial was performed to measure the outcomes of patients with complex wounds who received home wound care from a local clinician guided by an off-site wound care expert via telemedicine, versus patients who received in-home or wound clinic visits with wound care professionals. The publicly funded network of nurses and physicians highly experienced in wound healing was used to provide wound care recommendations via telemedicine for the study. The healing rate at 6 months was slightly better for patients who received wound care via telemedicine (61/89; 68.5%) versus wound care professional at home (38/59; 64.4%) versus wound care clinic (22/35; 62.9%), but the difference was not significant ( P = .860833). The average time to healing for the 121/183 wounds that healed within 6 months was 66.8 ± 32.8 days for the telemedicine group, 69.3 ± 26.7 for the wound care professional at home group, and 55.8 ± 25.0 days for the wound care clinic group. Transportation costs for the telemedicine and home health care groups were significantly lower than the wound clinic group, and death rate was similar between all the 3 groups ( P < .01). Telemedicine performed by wound healing clinicians working in a network setting offered a safe option to remotely manage comorbid, complex wound care patients with reduced mobility.",2020,"Transportation costs for the telemedicine and home health care groups were significantly lower than the wound clinic group, and death rate was similar between all the 3 groups ( P < .01).","['Outpatients', 'patients with complex wounds who received home wound care from a local clinician guided by an off-site wound care expert via telemedicine, versus patients who received in-home or wound clinic visits with wound care professionals']","['telemedicine', 'Receiving Care via Telemedicine, Home Health, or Wound Clinic', 'Telemedicine']","['average time to healing', 'Transportation costs', 'death rate', 'Complex Wound Healing Outcomes', 'healing rate']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0886052', 'cui_str': 'Administers care to wound sites'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}]",,0.0417822,"Transportation costs for the telemedicine and home health care groups were significantly lower than the wound clinic group, and death rate was similar between all the 3 groups ( P < .01).","[{'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Téot', 'Affiliation': 'Montpellier University Hospital, Montpellier, France.'}, {'ForeName': 'Chloé', 'Initials': 'C', 'LastName': 'Geri', 'Affiliation': 'Hospital Home Wound Care Network, Montpellier, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lano', 'Affiliation': 'Hospital Home Wound Care Network, Montpellier, France.'}, {'ForeName': 'Marjorie', 'Initials': 'M', 'LastName': 'Cabrol', 'Affiliation': 'Hospital Home Wound Care Network, Montpellier, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Linet', 'Affiliation': 'Hospital Home Wound Care Network, Montpellier, France.'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Mercier', 'Affiliation': 'Montpellier University Hospital, Montpellier, France.'}]",The international journal of lower extremity wounds,['10.1177/1534734619894485'] 325,31255890,"Evaluation of ultrasound-guided transversalis fascia plane block for postoperative analgesia in cesarean section: A prospective, randomized, controlled clinical trial.","STUDY OBJECTIVE Cesarean Delivery (CD) is a commonly performed obstetric procedure. Adding a regional anesthesia technique to multimodal analgesia in CD, may improve the quality of postoperative analgesia. In this study we evaluated the efficacy of Transversalis Fascia Plane Block (TFPB) for postoperative analgesia management in CD. DESIGN Blinded, prospective, randomized study. SETTING Postoperative recovery room & ward, tertiary university hospital, Istanbul, Turkey, PATIENTS: Seventy-five patients (ASA II-III) scheduled to undergo Cesarean delivery were recruited. Following exclusion, 70 patients were randomized into two equal groups (block and control group). INTERVENTIONS Standard multimodal analgesia (routine paracetamol and tramadol PCA in addition to diclophenac sodium as rescue analgesia) was performed in Group C while TFPB block was also performed in the intervention (TFPB) group. MEASUREMENTS The primary outcome was tramadol consumption within the first 24 h. The secondary outcome was Numeric Rating Scale (NRS) scores during rest and movement/coughing. MAIN RESULTS Tramadol consumption in the first 24 h was 175 ± 72.32 mg in the control and 101.42 ± 51.45 mg in the TFPB group (p < 0.05). NRS was lower in Group TFPB during the first 3 h and at the 12th hour. There was no difference in NRS scores at other hours. CONCLUSION Bilateral ultrasound guided TFPB leads to effective analgesia and a decrease in analgesia requirement in first 24 h in patients undergoing CD.",2020,"MAIN RESULTS Tramadol consumption in the first 24 h was 175 ± 72.32 mg in the control and 101.42 ± 51.45 mg in the TFPB group (p < 0.05).","['Postoperative recovery room & ward, tertiary university hospital, Istanbul, Turkey, PATIENTS: Seventy-five patients (ASA II-III) scheduled to undergo Cesarean delivery were recruited', 'cesarean section', '70 patients']","['Transversalis Fascia Plane Block (TFPB', 'ultrasound-guided transversalis fascia plane block', 'Standard multimodal analgesia (routine paracetamol and tramadol PCA']","['analgesia requirement', 'NRS', 'quality of postoperative analgesia', 'tramadol consumption', 'Numeric Rating Scale (NRS) scores during rest and movement/coughing', 'NRS scores']","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0041400', 'cui_str': 'Turkey'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}]","[{'cui': 'C0225232', 'cui_str': 'Transversalis fascia structure'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0030625', 'cui_str': 'PCA'}]","[{'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",70.0,0.0617133,"MAIN RESULTS Tramadol consumption in the first 24 h was 175 ± 72.32 mg in the control and 101.42 ± 51.45 mg in the TFPB group (p < 0.05).","[{'ForeName': 'Talat Ercan', 'Initials': 'TE', 'LastName': 'Serifsoy', 'Affiliation': 'Maltepe University Faculty of Medicine, Department of Anesthesiology and Reanimation, Istanbul, Turkey.'}, {'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Tulgar', 'Affiliation': 'Maltepe University Faculty of Medicine, Department of Anesthesiology and Reanimation, Istanbul, Turkey. Electronic address: serkan.tulgar@maltepe.edu.tr.'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Selvi', 'Affiliation': 'Maltepe University Faculty of Medicine, Department of Anesthesiology and Reanimation, Istanbul, Turkey.'}, {'ForeName': 'Ozgur', 'Initials': 'O', 'LastName': 'Senturk', 'Affiliation': 'Maltepe University Faculty of Medicine, Department of Anesthesiology and Reanimation, Istanbul, Turkey.'}, {'ForeName': 'Erdin', 'Initials': 'E', 'LastName': 'Ilter', 'Affiliation': 'Maltepe University Faculty of Medicine, Department of Obstetrics and Gynecology, Istanbul, Turkey.'}, {'ForeName': 'Berna Haliloglu', 'Initials': 'BH', 'LastName': 'Peker', 'Affiliation': 'Maltepe University Faculty of Medicine, Department of Obstetrics and Gynecology, Istanbul, Turkey.'}, {'ForeName': 'Zeliha', 'Initials': 'Z', 'LastName': 'Ozer', 'Affiliation': 'Maltepe University Faculty of Medicine, Department of Anesthesiology and Reanimation, Istanbul, Turkey.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2019.06.025'] 326,31257951,Evaluating and reducing xerosis in competitive swimmers: an in vitro study and randomized controlled clinical trial.,"INTRODUCTION Xerosis is a common problem with significant sequelae in competitive swimmers, and it results from transepidermal water loss. This study evaluates moisture barriers for reducing xerosis in competitive swimmers. METHODS An artificial skin model was used to evaluate five products. Models were measured for changes in thickness and weight over 7 days. The optimal barrier was tested in a randomized controlled trial (RCT) of 20 swimmers. Skin moisture content was serially measured. Skin micrographs were scored in a blinded fashion. RESULTS The moisture barrier #1 treated skin model at day 7 maintained a mean thickness of 7.08 mm versus 2.38 mm for control ( p  = .0001). The mean weights of group 1 treated and control groups at day 7 were 40.1 and 8.65 g ( p  = .03). In the RCT, the group treated with moisture barrier #1 and the controls exhibited low moisture content and moderate xerosis scores at baseline. At week 3, moisture measurements for treated and control groups were 28.6% and 18.2% ( p  = .003). The mean xerosis scores for the treated and control groups were 8.5 and 12.9 ( p  = .0008). CONCLUSIONS Artificial skin preservation varied for five commercially available moisture barriers. Moisture barrier application improved moisture content and reduced xerosis in competitive swimmers.",2021,"The mean xerosis scores for the treated and control groups were 8.5 and 12.9 (p = 0.0008). ","['20 swimmers', 'competitive swimmers', 'Competitive Swimmers']",[],"['low moisture content and moderate xerosis scores', 'mean weights', 'moisture content and reduced xerosis', 'mean xerosis scores', 'moisture measurements', 'Skin moisture content']","[{'cui': 'C0450068', 'cui_str': 'Swimmer (person)'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0259817', 'cui_str': 'Xerosis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1123023', 'cui_str': 'Skin'}]",,0.0691119,"The mean xerosis scores for the treated and control groups were 8.5 and 12.9 (p = 0.0008). ","[{'ForeName': 'Kimball', 'Initials': 'K', 'LastName': 'Sheehan', 'Affiliation': 'Department of Dermatology, University of Virginia.'}, {'ForeName': 'Darrah', 'Initials': 'D', 'LastName': 'Sheehan', 'Affiliation': 'Department of Dermatology, University of Virginia.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Margaret Noland', 'Affiliation': 'Department of Dermatology, University of Virginia.'}]",The Journal of dermatological treatment,['10.1080/09546634.2019.1638882'] 327,31197697,Comparative Perioperative Outcomes by Esophagectomy Surgical Technique.,"INTRODUCTION Surgical resection is vital in the curative management of patients with esophageal cancer. However, a myriad of surgical procedures exists based on surgeon preference and training. We report on the perioperative outcomes based on esophagectomy surgical technique. METHODS A prospectively managed esophagectomy database was queried for patients undergoing esophagectomy from 1996 and 2016. Basic demographics, tumor characteristics, operative details, and post-operative outcomes were recorded and analyzed by comparison of transhiatal vs Ivor-lewis and minimally invasive (MIE) vs open procedures. RESULTS We identified 856 patients who underwent esophagectomy. Neoadjuvant therapy was administered in 543 patients (63.4%). There were 504 (58.8%) open esophagectomies and 302 (35.2%) MIE. There were 13 (1.5%) mortalities and this did not differ among techniques (p = 0.6). While there was no difference in overall complications between MIE and open, complications occurred less frequently in patients undergoing RAIL and MIE IVL compared to other techniques (p = 0.003). Pulmonary complications also occurred less frequently in RAIL and MIE IVL (p < 0.001). Anastomotic leaks were less common in patients who underwent IVL compared to trans-hiatal approaches (p = 0.03). MIE patients were more likely to receive neoadjuvant therapy (p = 0.001), have lower blood loss (p < 0.001), have longer operations (p < 0.001), and higher lymph node harvests (p < 0.001) compared to open patients. CONCLUSION Minimally invasive and robotic Ivor Lewis techniques demonstrated substantial benefits in post-operative complications. Oncologic outcomes similarly favor MIE IVL and RAIL.",2020,"MIE patients were more likely to receive neoadjuvant therapy (p = 0.001), have lower blood loss (p < 0.001), have longer operations (p < 0.001), and higher lymph node harvests (p < 0.001) compared to open patients. ","['856 patients who underwent esophagectomy', '543 patients (63.4', 'patients undergoing esophagectomy from 1996 and 2016', 'patients with esophageal cancer']","['Esophagectomy Surgical Technique', 'esophagectomy surgical technique', 'MIE IVL and RAIL', 'Neoadjuvant therapy']","['lower blood loss', 'higher lymph node harvests', 'overall complications', 'Anastomotic leaks', 'Basic demographics, tumor characteristics, operative details, and post-operative outcomes', 'Pulmonary complications']","[{'cui': 'C4517894', 'cui_str': '856 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}]","[{'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1705114', 'cui_str': 'Rail'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant Treatment'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic Leakage'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}]",,0.0418486,"MIE patients were more likely to receive neoadjuvant therapy (p = 0.001), have lower blood loss (p < 0.001), have longer operations (p < 0.001), and higher lymph node harvests (p < 0.001) compared to open patients. ","[{'ForeName': 'Kenneth L', 'Initials': 'KL', 'LastName': 'Meredith', 'Affiliation': 'Gastrointestinal Oncology, Florida State University College Of Medicine/Sarasota Memorial Health Care System, 1950 Arlington Street, Suite 101, Sarasota, FL, 34239, USA. kensurg@hotmail.com.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Maramara', 'Affiliation': 'Gastrointestinal Oncology, Florida State University College Of Medicine/Sarasota Memorial Health Care System, 1950 Arlington Street, Suite 101, Sarasota, FL, 34239, USA.'}, {'ForeName': 'Paige', 'Initials': 'P', 'LastName': 'Blinn', 'Affiliation': 'Gastrointestinal Oncology, Florida State University College Of Medicine/Sarasota Memorial Health Care System, 1950 Arlington Street, Suite 101, Sarasota, FL, 34239, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': 'Gastrointestinal Oncology, Florida State University College Of Medicine/Sarasota Memorial Health Care System, 1950 Arlington Street, Suite 101, Sarasota, FL, 34239, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Huston', 'Affiliation': 'Gastrointestinal Oncology, Florida State University College Of Medicine/Sarasota Memorial Health Care System, 1950 Arlington Street, Suite 101, Sarasota, FL, 34239, USA.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Shridhar', 'Affiliation': 'Radiation Oncology, University of Central Florida, Orlando, FL, USA.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-019-04269-y'] 328,29374054,Immune Biomarkers Predictive for Disease-Free Survival with Adjuvant Sunitinib in High-Risk Locoregional Renal Cell Carcinoma: From Randomized Phase III S-TRAC Study.,"Purpose: Adjuvant sunitinib therapy compared with placebo prolonged disease-free survival (DFS) in patients with locoregional high-risk renal cell carcinoma (RCC) in the S-TRAC trial (ClinicalTrials.gov number NCT00375674). A prospectively designed exploratory analysis of tissue biomarkers was conducted to identify predictors of treatment benefit. Experimental Design: Tissue blocks were used for immunohistochemistry (IHC) staining of programmed cell death ligand 1 (PD-L1), CD4, CD8, and CD68. DFS was compared between < versus ≥ median IHC parameter using the Kaplan-Meier method. For biomarkers with predictive potential, receiver operating characteristics curves were generated. Results: Baseline characteristics were similar in patients with ( n = 191) and without ( n = 419) IHC analysis. Among patients with IHC, longer DFS was observed in patients with tumor CD8 + T-cell density ≥ versus < median [median (95% CI), not reached (6.83-not reached) versus 3.47 years (1.73-not reached); hazard ratio (HR) 0.40 (95% CI, 0.20-0.81); P = 0.009] treated with sunitinib ( n = 101), but not with placebo ( n = 90). The sensitivity and specificity for CD8 + T-cell density in predicting DFS were 0.604 and 0.658, respectively. Shorter DFS was observed in placebo-treated patients with PD-L1 + versus PD-L1 - tumors (HR 1.75; P = 0.103). Among all patients with PD-L1 + tumors, DFS was numerically longer with sunitinib versus placebo (HR 0.58; P = 0.175). Conclusions: Greater CD8 + T-cell density in tumor tissue was associated with longer DFS with sunitinib but not placebo, suggesting predictive treatment effect utility. Further independent cohort validation studies are warranted. The prognostic value of PD-L1 expression in primary tumors from patients with high-risk nonmetastatic RCC should also be further explored. Clin Cancer Res; 24(7); 1554-61. ©2018 AACR .",2018,"Conclusions: Greater CD8 + T-cell density in tumor tissue was associated with longer DFS with sunitinib but not placebo, suggesting predictive treatment effect utility.","['patients with locoregional high-risk renal cell carcinoma (RCC', 'High-Risk Locoregional Renal Cell Carcinoma', 'primary tumors from patients with high-risk nonmetastatic RCC']","['Adjuvant Sunitinib', 'placebo', 'sunitinib']","['DFS', 'sensitivity and specificity for CD8 + T-cell density', 'CD8 + T-cell density in tumor tissue', 'disease-free survival (DFS', 'Shorter DFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]","[{'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample (specimen)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]",,0.150531,"Conclusions: Greater CD8 + T-cell density in tumor tissue was associated with longer DFS with sunitinib but not placebo, suggesting predictive treatment effect utility.","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'George', 'Affiliation': 'Duke Cancer Institute, Division of Oncology, Durham, North Carolina. daniel.george@duke.edu.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Martini', 'Affiliation': 'Pfizer Inc., La Jolla, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Staehler', 'Affiliation': 'Hospital of Munich, Department of Urology, Munich, Germany.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Department of Oncology, New York, New York.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Magheli', 'Affiliation': 'Charité Universitaetsmedizin Berlin, Department of Urology, Berlin, Germany.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Escudier', 'Affiliation': 'Institut Gustave Roussy, Department of Medical Oncology, Villejuif, France.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Gerletti', 'Affiliation': 'Pfizer S.r.L, Milan, Italy.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Pfizer Inc., La Jolla, California.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Casey', 'Affiliation': 'Pfizer Inc., Collegeville, Pennsylvania.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Laguerre', 'Affiliation': 'Centre Eugene Marquis, Medical Oncology, Rennes, France.'}, {'ForeName': 'Hardev S', 'Initials': 'HS', 'LastName': 'Pandha', 'Affiliation': 'University of Surrey, Department of Clinical and Experimental Medicine, Surrey, United Kingdom.'}, {'ForeName': 'Allan J', 'Initials': 'AJ', 'LastName': 'Pantuck', 'Affiliation': 'Ronald Reagan UCLA Medical Center, Department of Urology, Los Angeles, California.'}, {'ForeName': 'Anup', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Spire Roding Hospital, London, United Kingdom.'}, {'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Lechuga', 'Affiliation': 'Pfizer S.r.L, Milan, Italy.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Ravaud', 'Affiliation': 'Bordeaux University Hospital, Department of Medical Oncology, Bordeaux, France.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-17-2822'] 329,31760846,Effect of Cedar ( Ziziphus spina-christi ) topical solution in mild to moderate acne vulgaris: a randomized clinical study.,"BACKGROUND Acne is the most prevalent skin disease in the world and antibiotics as its standard treatments have limited and also adverse effects. Cedar ( Ziziphus spina-christi ) has medicinal properties like antibacterial activity and is used topically for treatment of some kinds of skin problems in Persian medicine. The aim of this study was to evaluation the efficacy of topical cedar solution of acne vulgaris. METHODS Eighty patients aged between 15-45 years with mild to moderate acne vulgaris were conducted in this randomized, double blind trial. The participants were allocated to receive the topical cedar solution plus clindamycin 1% or topical placebo plus 1% clindamycin solution for six weeks. Patients were evaluated at the beginning of the study, second, sixth and eighth weeks after intervention for the acne severity index (ASI) and total acne lesions counting (TLC). Data was analyzed by SPSS software with Mann-Whitney U test. RESULTS From 105 subjects 68 people completed the study (33 persons in cedar group and 35 persons in placebo group). The mean and standard deviation of the age was 26.1 ± 7.5 years and 22 subjects (32.4%) were male. TLC and ASI in the sixth and eighth weeks in cedar group were significantly less than in placebo group ( p  < 0.001). Topical cedar solution had no serious side effects. CONCLUSION The topical cedar solution plus clindamycin 1% was more effective and safe than placebo plus 1% clindamycin for the treatment of acne vulgaris.",2021,The topical cedar solution plus clindamycin 1% was more effective and safe than placebo plus 1% clindamycin for the treatment of acne vulgaris.,"['105 subjects 68 people completed the study (33 persons in cedar group and 35 persons in placebo group', 'Cedar ( Ziziphus spina-christi ', 'mild to moderate acne vulgaris', 'The mean and standard deviation of the age was 26.1\u2009±\u20097.5\u2009years and 22 subjects (32.4%) were male', 'Eighty patients aged between 15-45\u2009years with mild to moderate acne vulgaris', 'acne vulgaris']","['topical cedar solution', 'clindamycin', 'topical cedar solution plus clindamycin', 'Cedar ( Ziziphus spina-christi ) topical solution', 'placebo', 'topical cedar solution plus clindamycin 1% or topical placebo plus 1% clindamycin solution', 'Topical cedar solution']","['effective and safe', 'TLC and ASI', 'serious side effects', 'acne severity index (ASI) and total acne lesions counting (TLC']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1029148', 'cui_str': 'Ziziphus'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0001144', 'cui_str': 'Acne Vulgaris'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517709', 'cui_str': '32.4 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0008947', 'cui_str': 'Clindamycin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1029148', 'cui_str': 'Ziziphus'}, {'cui': 'C0991555', 'cui_str': 'Topical Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0040509', 'cui_str': 'Total Lung Capacity'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}]",80.0,0.419249,The topical cedar solution plus clindamycin 1% was more effective and safe than placebo plus 1% clindamycin for the treatment of acne vulgaris.,"[{'ForeName': 'Rasoul', 'Initials': 'R', 'LastName': 'Shakiba', 'Affiliation': 'Research Institute for Islamic and Complementary Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Nilforoushzadeh', 'Affiliation': 'Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fataneh', 'Initials': 'F', 'LastName': 'Hashem-Dabaghian', 'Affiliation': 'Research Institute for Islamic and Complementary Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Bagher', 'Initials': 'B', 'LastName': 'Minaii Zangii', 'Affiliation': 'Department of Histology, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ghobadi', 'Affiliation': 'Research Institute for Islamic and Complementary Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'Shirbeigi', 'Affiliation': 'Department of Traditional Medicine, School of Traditional Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Jale', 'Initials': 'J', 'LastName': 'Aliasl', 'Affiliation': 'Traditional Medicine Clinical Trial Research Center, Shahed University, Tehran, Iran.'}, {'ForeName': 'Mahdad', 'Initials': 'M', 'LastName': 'Shakiba', 'Affiliation': 'School of Pharmacy, International Campus, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Roshanak', 'Initials': 'R', 'LastName': 'Ghods', 'Affiliation': 'Research Institute for Islamic and Complementary Medicine, Iran University of Medical Sciences, Tehran, Iran.'}]",The Journal of dermatological treatment,['10.1080/09546634.2019.1692125'] 330,31180258,Efficacy of stem cell-conditioned medium vs. platelet-rich plasma as an adjuvant to ablative fractional CO 2 laser resurfacing for atrophic post-acne scars: a split-face clinical trial.,"OBJECTIVES To explore the impact of using topical stem cell-conditioned medium (SC-CM) after fractional carbon dioxide laser (FCL) vs. combined FCL and platelet-rich plasma (PRP) or FCL alone in treatment of atrophic acne scars. METHODS Thirty-three patients were randomly divided into two split-face groups. Group I ( n   =  17) received FCL plus topical SC-CM on one side or FCL plus saline on the other. Group II ( n   =  16) received FCL plus topical PRP or SC-CM. All patients had three monthly sessions. Clinical assessment was done at each visit, with a final assessment after 3 months. Skin biopsies were obtained for histological and quantitative molecular analysis after treatment. RESULTS No significant difference in clinical improvement of acne scars was observed between the FCL/SC-CM and FCL only sides ( p  = .63), while better and faster improvement was detected on FCL/PRP side compared to FCL/SC-CM side ( p  = .006). There was no significant difference in downtime or adverse effects between the treated sides in either group. Dermal collagen was increased and procollagen type I gene was upregulated in both FCL/PRP and FCL/SC-CM sides compared to FCL only sides ( p  = .001 and p  = .041, respectively). CONCLUSIONS Topical SC-CM could potentially enhance the efficacy of FCL. However, PRP seems to be a better alternative.",2021,"No significant difference in clinical improvement of acne scars was observed between the FCL/SC-CM and FCL only sides ( p  = .63), while better and faster improvement was detected on FCL/PRP side compared to FCL/SC-CM side ( p  = .006).","['atrophic post-acne scars', 'atrophic acne scars', 'Methods: Thirty-three patients']","['topical stem cell-conditioned medium (SC-CM', 'FCL plus topical PRP or SC-CM', 'Topical SC-CM', 'fractional carbon dioxide laser (FCL) vs. combined FCL and platelet-rich plasma (PRP) or FCL alone', 'stem cell-conditioned medium vs. platelet-rich plasma', 'laser resurfacing', 'FCL plus topical SC-CM on one side or FCL plus saline']","['Dermal collagen', 'downtime or adverse effects', 'clinical improvement of acne scars', 'procollagen type']","[{'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0423783', 'cui_str': 'Acne scar (disorder)'}, {'cui': 'C1274728', 'cui_str': 'Atrophic acne scar'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0162518', 'cui_str': 'Conditioned Medium'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C0392251', 'cui_str': 'CO2 Lasers'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0423783', 'cui_str': 'Acne scar (disorder)'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]",33.0,0.0330577,"No significant difference in clinical improvement of acne scars was observed between the FCL/SC-CM and FCL only sides ( p  = .63), while better and faster improvement was detected on FCL/PRP side compared to FCL/SC-CM side ( p  = .006).","[{'ForeName': 'Ensaf M', 'Initials': 'EM', 'LastName': 'Abdel-Maguid', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Assiut University Hospital, Assiut, Egypt.'}, {'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Awad', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Assiut University Hospital, Assiut, Egypt.'}, {'ForeName': 'Youssef S', 'Initials': 'YS', 'LastName': 'Hassan', 'Affiliation': 'Department of Plastic Surgery, Assiut University Hospital, Assiut, Egypt.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'El-Mokhtar', 'Affiliation': 'Department of Microbiology and Immunology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Heba Em', 'Initials': 'HE', 'LastName': 'El-Deek', 'Affiliation': 'Department of Pathology, Assiut University Hospital, Assiut, Egypt.'}, {'ForeName': 'Marwa Ma', 'Initials': 'MM', 'LastName': 'Mekkawy', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Assiut University Hospital, Assiut, Egypt.'}]",The Journal of dermatological treatment,['10.1080/09546634.2019.1630701'] 331,31484712,Sex differences by design and outcome in the Safety of Urate Elevation in PD (SURE-PD) trial.,"OBJECTIVE To investigate whether women and men with Parkinson disease (PD) differ in their biochemical and clinical responses to long-term treatment with inosine. METHODS The Safety of Urate Elevation in Parkinson's Disease (SURE-PD) trial enrolled 75 people with early PD and baseline serum urate below 6 mg/dL and randomized them to 3 double-blinded treatment arms: oral placebo or inosine titrated to produce mild (6.1-7.0 mg/dL) or moderate (7.1-8.0 mg/dL) serum urate elevation for up to 2 years. Parkinsonism, serum urate, and plasma antioxidant capacity were measured at baseline and repeatedly on treatment; CSF urate was assessed once, at 3 months. Here in secondary analyses results are stratified by sex. RESULTS Inosine produced an absolute increase in average serum urate from baseline that was 50% greater in women (3.0 mg/dL) than in men (2.0 mg/dL), consistent with expected lower baseline levels in women. Similarly, only among women was CSF urate significantly greater on mild or moderate inosine (+87% [ p < 0.001] and +98% [ p < 0.001], respectively) than on placebo (in contrast to men: +10% [ p = 0.6] and +14% [ p = 0.4], respectively). Women in the higher inosine dosing group showed a 7.0 Unified Parkinson's Disease Rating Scale (UPDRS) points/year lower rate of decline vs placebo ( p = 0.01). In women, slower rates of UPDRS change were associated with greater increases in serum urate ( r = -0.52; p = 0.001), and with greater increases in plasma antioxidant capacity ( r = -0.44; p = 0.006). No significant associations were observed in men. CONCLUSIONS Inosine produced greater increases in serum and CSF urate in women compared to men in the SURE-PD trial, consistent with the study's design and with preliminary evidence for slower clinical decline in early PD among women treated with urate-elevating doses of inosine. CLINICALTRIALSGOV IDENTIFIER NCT00833690. CLASSIFICATION OF EVIDENCE This study provides Class II evidence that inosine produced greater urate elevation in women than men and may slow PD progression in women.",2019,Women in the higher inosine dosing group showed a 7.0 Unified Parkinson's Disease Rating Scale (UPDRS) points/year lower rate of decline vs placebo ( p = 0.01).,"['women and men with Parkinson disease (PD', 'women than men and may slow PD progression in women', ""Parkinson's Disease (SURE-PD) trial enrolled 75 people with early PD and baseline serum urate below 6 mg/dL and randomized them to 3 double-blinded treatment arms""]","['placebo', 'oral placebo']","['CSF urate significantly greater on mild or moderate inosine', 'average serum urate', 'Parkinsonism, serum urate, and plasma antioxidant capacity', 'serum urate', 'serum and CSF urate', 'rates of UPDRS change', 'plasma antioxidant capacity', 'urate elevation', ""Unified Parkinson's Disease Rating Scale (UPDRS""]","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0935936', 'cui_str': 'Urate'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0935936', 'cui_str': 'Urate'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0021528', 'cui_str': 'Inosine'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0242422', 'cui_str': 'Parkinsonism'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0222045'}]",75.0,0.51516,Women in the higher inosine dosing group showed a 7.0 Unified Parkinson's Disease Rating Scale (UPDRS) points/year lower rate of decline vs placebo ( p = 0.01).,"[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Schwarzschild', 'Affiliation': ""From the Departments of Neurology (M.A.S., R.B., S.B., R.L., A.Y.H., G.B.) and Medicine (E.A.M.), Massachusetts General Hospital, Boston; University of Cincinnati (A.J.E.), OH; Rush University (C.G.G.), Chicago, IL; Michigan State University (J.L.G.), East Lansing; Struthers Parkinson's Center (S.A.P.), Minneapolis, MN; Boston University (M.H.S.-H.), MA; University of Rochester (A.R.), NY; University of Miami (J.M.H.), FL; Brigham and Women's Hospital (G.C.C.), Boston, MA; Yale University School of Medicine (D.S.R.), New Haven, CT; and Department of Nutrition (A.A.), Harvard School of Public Health, Boston, MA. michaels@helix.mgh.harvard.edu.""}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Macklin', 'Affiliation': ""From the Departments of Neurology (M.A.S., R.B., S.B., R.L., A.Y.H., G.B.) and Medicine (E.A.M.), Massachusetts General Hospital, Boston; University of Cincinnati (A.J.E.), OH; Rush University (C.G.G.), Chicago, IL; Michigan State University (J.L.G.), East Lansing; Struthers Parkinson's Center (S.A.P.), Minneapolis, MN; Boston University (M.H.S.-H.), MA; University of Rochester (A.R.), NY; University of Miami (J.M.H.), FL; Brigham and Women's Hospital (G.C.C.), Boston, MA; Yale University School of Medicine (D.S.R.), New Haven, CT; and Department of Nutrition (A.A.), Harvard School of Public Health, Boston, MA.""}, {'ForeName': 'Rachit', 'Initials': 'R', 'LastName': 'Bakshi', 'Affiliation': ""From the Departments of Neurology (M.A.S., R.B., S.B., R.L., A.Y.H., G.B.) and Medicine (E.A.M.), Massachusetts General Hospital, Boston; University of Cincinnati (A.J.E.), OH; Rush University (C.G.G.), Chicago, IL; Michigan State University (J.L.G.), East Lansing; Struthers Parkinson's Center (S.A.P.), Minneapolis, MN; Boston University (M.H.S.-H.), MA; University of Rochester (A.R.), NY; University of Miami (J.M.H.), FL; Brigham and Women's Hospital (G.C.C.), Boston, MA; Yale University School of Medicine (D.S.R.), New Haven, CT; and Department of Nutrition (A.A.), Harvard School of Public Health, Boston, MA.""}, {'ForeName': 'Shamik', 'Initials': 'S', 'LastName': 'Battacharyya', 'Affiliation': ""From the Departments of Neurology (M.A.S., R.B., S.B., R.L., A.Y.H., G.B.) and Medicine (E.A.M.), Massachusetts General Hospital, Boston; University of Cincinnati (A.J.E.), OH; Rush University (C.G.G.), Chicago, IL; Michigan State University (J.L.G.), East Lansing; Struthers Parkinson's Center (S.A.P.), Minneapolis, MN; Boston University (M.H.S.-H.), MA; University of Rochester (A.R.), NY; University of Miami (J.M.H.), FL; Brigham and Women's Hospital (G.C.C.), Boston, MA; Yale University School of Medicine (D.S.R.), New Haven, CT; and Department of Nutrition (A.A.), Harvard School of Public Health, Boston, MA.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Logan', 'Affiliation': ""From the Departments of Neurology (M.A.S., R.B., S.B., R.L., A.Y.H., G.B.) and Medicine (E.A.M.), Massachusetts General Hospital, Boston; University of Cincinnati (A.J.E.), OH; Rush University (C.G.G.), Chicago, IL; Michigan State University (J.L.G.), East Lansing; Struthers Parkinson's Center (S.A.P.), Minneapolis, MN; Boston University (M.H.S.-H.), MA; University of Rochester (A.R.), NY; University of Miami (J.M.H.), FL; Brigham and Women's Hospital (G.C.C.), Boston, MA; Yale University School of Medicine (D.S.R.), New Haven, CT; and Department of Nutrition (A.A.), Harvard School of Public Health, Boston, MA.""}, {'ForeName': 'Alberto J', 'Initials': 'AJ', 'LastName': 'Espay', 'Affiliation': ""From the Departments of Neurology (M.A.S., R.B., S.B., R.L., A.Y.H., G.B.) and Medicine (E.A.M.), Massachusetts General Hospital, Boston; University of Cincinnati (A.J.E.), OH; Rush University (C.G.G.), Chicago, IL; Michigan State University (J.L.G.), East Lansing; Struthers Parkinson's Center (S.A.P.), Minneapolis, MN; Boston University (M.H.S.-H.), MA; University of Rochester (A.R.), NY; University of Miami (J.M.H.), FL; Brigham and Women's Hospital (G.C.C.), Boston, MA; Yale University School of Medicine (D.S.R.), New Haven, CT; and Department of Nutrition (A.A.), Harvard School of Public Health, Boston, MA.""}, {'ForeName': 'Albert Y', 'Initials': 'AY', 'LastName': 'Hung', 'Affiliation': ""From the Departments of Neurology (M.A.S., R.B., S.B., R.L., A.Y.H., G.B.) and Medicine (E.A.M.), Massachusetts General Hospital, Boston; University of Cincinnati (A.J.E.), OH; Rush University (C.G.G.), Chicago, IL; Michigan State University (J.L.G.), East Lansing; Struthers Parkinson's Center (S.A.P.), Minneapolis, MN; Boston University (M.H.S.-H.), MA; University of Rochester (A.R.), NY; University of Miami (J.M.H.), FL; Brigham and Women's Hospital (G.C.C.), Boston, MA; Yale University School of Medicine (D.S.R.), New Haven, CT; and Department of Nutrition (A.A.), Harvard School of Public Health, Boston, MA.""}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Bwala', 'Affiliation': ""From the Departments of Neurology (M.A.S., R.B., S.B., R.L., A.Y.H., G.B.) and Medicine (E.A.M.), Massachusetts General Hospital, Boston; University of Cincinnati (A.J.E.), OH; Rush University (C.G.G.), Chicago, IL; Michigan State University (J.L.G.), East Lansing; Struthers Parkinson's Center (S.A.P.), Minneapolis, MN; Boston University (M.H.S.-H.), MA; University of Rochester (A.R.), NY; University of Miami (J.M.H.), FL; Brigham and Women's Hospital (G.C.C.), Boston, MA; Yale University School of Medicine (D.S.R.), New Haven, CT; and Department of Nutrition (A.A.), Harvard School of Public Health, Boston, MA.""}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Goetz', 'Affiliation': ""From the Departments of Neurology (M.A.S., R.B., S.B., R.L., A.Y.H., G.B.) and Medicine (E.A.M.), Massachusetts General Hospital, Boston; University of Cincinnati (A.J.E.), OH; Rush University (C.G.G.), Chicago, IL; Michigan State University (J.L.G.), East Lansing; Struthers Parkinson's Center (S.A.P.), Minneapolis, MN; Boston University (M.H.S.-H.), MA; University of Rochester (A.R.), NY; University of Miami (J.M.H.), FL; Brigham and Women's Hospital (G.C.C.), Boston, MA; Yale University School of Medicine (D.S.R.), New Haven, CT; and Department of Nutrition (A.A.), Harvard School of Public Health, Boston, MA.""}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Russell', 'Affiliation': ""From the Departments of Neurology (M.A.S., R.B., S.B., R.L., A.Y.H., G.B.) and Medicine (E.A.M.), Massachusetts General Hospital, Boston; University of Cincinnati (A.J.E.), OH; Rush University (C.G.G.), Chicago, IL; Michigan State University (J.L.G.), East Lansing; Struthers Parkinson's Center (S.A.P.), Minneapolis, MN; Boston University (M.H.S.-H.), MA; University of Rochester (A.R.), NY; University of Miami (J.M.H.), FL; Brigham and Women's Hospital (G.C.C.), Boston, MA; Yale University School of Medicine (D.S.R.), New Haven, CT; and Department of Nutrition (A.A.), Harvard School of Public Health, Boston, MA.""}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Goudreau', 'Affiliation': ""From the Departments of Neurology (M.A.S., R.B., S.B., R.L., A.Y.H., G.B.) and Medicine (E.A.M.), Massachusetts General Hospital, Boston; University of Cincinnati (A.J.E.), OH; Rush University (C.G.G.), Chicago, IL; Michigan State University (J.L.G.), East Lansing; Struthers Parkinson's Center (S.A.P.), Minneapolis, MN; Boston University (M.H.S.-H.), MA; University of Rochester (A.R.), NY; University of Miami (J.M.H.), FL; Brigham and Women's Hospital (G.C.C.), Boston, MA; Yale University School of Medicine (D.S.R.), New Haven, CT; and Department of Nutrition (A.A.), Harvard School of Public Health, Boston, MA.""}, {'ForeName': 'Sotirios A', 'Initials': 'SA', 'LastName': 'Parashos', 'Affiliation': ""From the Departments of Neurology (M.A.S., R.B., S.B., R.L., A.Y.H., G.B.) and Medicine (E.A.M.), Massachusetts General Hospital, Boston; University of Cincinnati (A.J.E.), OH; Rush University (C.G.G.), Chicago, IL; Michigan State University (J.L.G.), East Lansing; Struthers Parkinson's Center (S.A.P.), Minneapolis, MN; Boston University (M.H.S.-H.), MA; University of Rochester (A.R.), NY; University of Miami (J.M.H.), FL; Brigham and Women's Hospital (G.C.C.), Boston, MA; Yale University School of Medicine (D.S.R.), New Haven, CT; and Department of Nutrition (A.A.), Harvard School of Public Health, Boston, MA.""}, {'ForeName': 'Marie H', 'Initials': 'MH', 'LastName': 'Saint-Hilaire', 'Affiliation': ""From the Departments of Neurology (M.A.S., R.B., S.B., R.L., A.Y.H., G.B.) and Medicine (E.A.M.), Massachusetts General Hospital, Boston; University of Cincinnati (A.J.E.), OH; Rush University (C.G.G.), Chicago, IL; Michigan State University (J.L.G.), East Lansing; Struthers Parkinson's Center (S.A.P.), Minneapolis, MN; Boston University (M.H.S.-H.), MA; University of Rochester (A.R.), NY; University of Miami (J.M.H.), FL; Brigham and Women's Hospital (G.C.C.), Boston, MA; Yale University School of Medicine (D.S.R.), New Haven, CT; and Department of Nutrition (A.A.), Harvard School of Public Health, Boston, MA.""}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Rudolph', 'Affiliation': ""From the Departments of Neurology (M.A.S., R.B., S.B., R.L., A.Y.H., G.B.) and Medicine (E.A.M.), Massachusetts General Hospital, Boston; University of Cincinnati (A.J.E.), OH; Rush University (C.G.G.), Chicago, IL; Michigan State University (J.L.G.), East Lansing; Struthers Parkinson's Center (S.A.P.), Minneapolis, MN; Boston University (M.H.S.-H.), MA; University of Rochester (A.R.), NY; University of Miami (J.M.H.), FL; Brigham and Women's Hospital (G.C.C.), Boston, MA; Yale University School of Medicine (D.S.R.), New Haven, CT; and Department of Nutrition (A.A.), Harvard School of Public Health, Boston, MA.""}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Hare', 'Affiliation': ""From the Departments of Neurology (M.A.S., R.B., S.B., R.L., A.Y.H., G.B.) and Medicine (E.A.M.), Massachusetts General Hospital, Boston; University of Cincinnati (A.J.E.), OH; Rush University (C.G.G.), Chicago, IL; Michigan State University (J.L.G.), East Lansing; Struthers Parkinson's Center (S.A.P.), Minneapolis, MN; Boston University (M.H.S.-H.), MA; University of Rochester (A.R.), NY; University of Miami (J.M.H.), FL; Brigham and Women's Hospital (G.C.C.), Boston, MA; Yale University School of Medicine (D.S.R.), New Haven, CT; and Department of Nutrition (A.A.), Harvard School of Public Health, Boston, MA.""}, {'ForeName': 'Gary C', 'Initials': 'GC', 'LastName': 'Curhan', 'Affiliation': ""From the Departments of Neurology (M.A.S., R.B., S.B., R.L., A.Y.H., G.B.) and Medicine (E.A.M.), Massachusetts General Hospital, Boston; University of Cincinnati (A.J.E.), OH; Rush University (C.G.G.), Chicago, IL; Michigan State University (J.L.G.), East Lansing; Struthers Parkinson's Center (S.A.P.), Minneapolis, MN; Boston University (M.H.S.-H.), MA; University of Rochester (A.R.), NY; University of Miami (J.M.H.), FL; Brigham and Women's Hospital (G.C.C.), Boston, MA; Yale University School of Medicine (D.S.R.), New Haven, CT; and Department of Nutrition (A.A.), Harvard School of Public Health, Boston, MA.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Ascherio', 'Affiliation': ""From the Departments of Neurology (M.A.S., R.B., S.B., R.L., A.Y.H., G.B.) and Medicine (E.A.M.), Massachusetts General Hospital, Boston; University of Cincinnati (A.J.E.), OH; Rush University (C.G.G.), Chicago, IL; Michigan State University (J.L.G.), East Lansing; Struthers Parkinson's Center (S.A.P.), Minneapolis, MN; Boston University (M.H.S.-H.), MA; University of Rochester (A.R.), NY; University of Miami (J.M.H.), FL; Brigham and Women's Hospital (G.C.C.), Boston, MA; Yale University School of Medicine (D.S.R.), New Haven, CT; and Department of Nutrition (A.A.), Harvard School of Public Health, Boston, MA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology,['10.1212/WNL.0000000000008194'] 332,25376639,Racial differences in abnormal ambulatory blood pressure monitoring measures: Results from the Coronary Artery Risk Development in Young Adults (CARDIA) study.,"BACKGROUND Several ambulatory blood pressure monitoring (ABPM) measures have been associated with increased cardiovascular disease risk independent of clinic blood pressure (BP). African Americans have higher clinic BP compared with Whites but few data are available on racial differences in ABPM measures. METHODS We compared ABPM measures between African American (n = 178) and White (n = 103) participants at the Year 5 Coronary Artery Risk Development in Young Adults study visit. BP was measured during a study visit and the second and third measurements were averaged. ABPM was conducted over the following 24 hours. RESULTS Mean ± SD age of participants was 29.8 ± 3.8 years and 30.8 ± 3.5 years for African Americans and Whites, respectively. Mean daytime systolic BP (SBP) was 3.90 (SD 1.18) mm Hg higher among African Americans compared with Whites (P < 0.001) after age-gender adjustment and 1.71 (SD 1.03) mm Hg higher after multivariable adjustment including mean clinic SBP (P = 0.10). After multivariable adjustment including mean clinic SBP, nighttime SBP was 4.83 (SD 1.11) mm Hg higher among African Americans compared with Whites (P < 0.001). After multivariable adjustment, the African Americans were more likely than Whites to have nocturnal hypertension (prevalence ratio: 2.44, 95% CI: 0.99-6.05) and nondipping (prevalence ratio: 2.50, 95% CI: 1.39-4.48). The prevalence of masked hypertension among African Americans and Whites was 4.4% and 2.1%, respectively, (P = 0.49) and white coat hypertension was 3.3% and 3.9%, respectively (P = 0.99). Twenty-four hour BP variability on ABPM was higher among African Americans compared with Whites. CONCLUSIONS These data suggest racial differences in several ABPM measures exist.",2015,"After multivariable adjustment, the African Americans were more likely than Whites to have nocturnal hypertension (prevalence ratio: 2.44, 95% CI: 0.99-6.05) and nondipping (prevalence ratio: 2.50, 95% CI: 1.39-4.48).","['African Americans', 'Young Adults (CARDIA) study', 'Mean ± SD age of participants was 29.8 ± 3.8 years and 30.8 ± 3.5 years for African Americans and Whites, respectively', 'African American (n = 178) and White (n = 103) participants at the Year 5 Coronary Artery Risk Development in Young Adults study visit']",[],"['white coat hypertension', 'ABPM', 'Mean daytime systolic BP (SBP', 'mean clinic SBP, nighttime SBP', 'BP variability on ABPM', 'BP', 'clinic BP', 'nocturnal hypertension', 'clinic blood pressure (BP', 'mean clinic SBP']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0243107', 'cui_str': 'development'}]",[],"[{'cui': 'C0262534', 'cui_str': 'White Coat Syndrome'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",103.0,0.0484473,"After multivariable adjustment, the African Americans were more likely than Whites to have nocturnal hypertension (prevalence ratio: 2.44, 95% CI: 0.99-6.05) and nondipping (prevalence ratio: 2.50, 95% CI: 1.39-4.48).","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Muntner', 'Affiliation': 'Department of Epidemiology, University of Alabama at Birmingham, Birmingham, Alabama, USA; pmuntner@uab.edu.'}, {'ForeName': 'Cora E', 'Initials': 'CE', 'LastName': 'Lewis', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA;'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Diaz', 'Affiliation': 'Department of Medicine, Columbia University, New York, New York, USA;'}, {'ForeName': 'April P', 'Initials': 'AP', 'LastName': 'Carson', 'Affiliation': 'Department of Epidemiology, University of Alabama at Birmingham, Birmingham, Alabama, USA;'}, {'ForeName': 'Yongin', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA;'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Calhoun', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA;'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Yano', 'Affiliation': 'Department of Preventive Medicine, Northwestern University, Chicago, Illinois, USA;'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Viera', 'Affiliation': 'Department of Family Medicine, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Daichi', 'Initials': 'D', 'LastName': 'Shimbo', 'Affiliation': 'Department of Medicine, Columbia University, New York, New York, USA;'}]",American journal of hypertension,['10.1093/ajh/hpu193'] 333,31763512,"Everolimus Exposure as a Predictor of Toxicity in Renal Cell Cancer Patients in the Adjuvant Setting: Results of a Pharmacokinetic Analysis for SWOG S0931 (EVEREST), a Phase III Study (NCT01120249).","Background S0931 is assessing recurrence-free survival in renal cell carcinoma (RCC) patients randomized to receive everolimus (EVE) versus placebo for one year following nephrectomy. Due to a higher than expected dropout rate, we assessed EVE trough levels in the adjuvant setting to evaluate the relationship between EVE exposure and probability of toxicity. Methods Patients received 10 mg daily EVE for nine 6-week cycles. Pre-dose whole blood samples were collected pre-cycle 2 and pre-cycle 3 and analyzed for EVE. Patients with pre-cycle 2 and/or pre-cycle 3 EVE results were used in the analysis. Patients were segregated into quartiles (Q) based on EVE levels and logistic regression was used to model the most common adverse event outcomes using EVE trough as a predictor. Hazard and odds ratios were adjusted for age, BMI and performance status. Results A total of 467 patients were included in this analysis. Quartiles normalized to an EVE dose of 10 mg/day were < 9.0, 9.0-12.9, 12.9-22.8, and > 22.8 ng/mL, respectively. EVE trough levels increased with increasing age ( p  < 0.001). Furthermore, EVE trough levels were higher in men than women (19.4 versus 15.4 ng/mL, p  = 0.01). Risk of grade 2 + triglycerides was increased in Q2 and Q3 vs Q1 (OR = 2.08; p  = 0.02 and OR = 2.63; p  = 0.002). Risk of grade 2 + rash was increased in Q2 and Q4 vs Q1 (OR = 2.99; p  = 0.01 and OR = 2.90; p  = 0.02). There was also an increased risk of any grade 3 + tox in Q2 vs Q1 (OR = 1.71; p  = 0.05). Conclusions We identified significant gender and age-related differences in EVE trough levels in patients receiving adjuvant treatment for RCC. Furthermore, our analysis identified significant associations between EVE exposure and probability of toxicity.",2019,Risk of grade 2 + triglycerides was increased in Q2 and Q3 vs Q1 (OR = 2.08; p  = ,"['A total of 467 patients were included in this analysis', 'Renal Cell Cancer Patients in the Adjuvant Setting', 'renal cell carcinoma (RCC) patients', 'patients receiving adjuvant treatment for RCC']","['everolimus (EVE) versus placebo', 'Everolimus']","['Risk of grade 2\u200a+\u200atriglycerides', 'Furthermore, EVE trough levels', 'EVE trough levels', 'EVE exposure and probability of toxicity', 'Risk of grade 2\u200a+\u200arash']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517784', 'cui_str': '467 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0047006', 'cui_str': '(R,S)-N-ethyl-3,4-methylenedioxyamphetamine'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}]",467.0,0.188496,Risk of grade 2 + triglycerides was increased in Q2 and Q3 vs Q1 (OR = 2.08; p  = ,"[{'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Synold', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Plets', 'Affiliation': 'SWOG Statistical Center/Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Tangen', 'Affiliation': 'SWOG Statistical Center/Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Elisabeth I', 'Initials': 'EI', 'LastName': 'Heath', 'Affiliation': 'Barbara Ann Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA.'}, {'ForeName': 'Ganesh S', 'Initials': 'GS', 'LastName': 'Palapattu', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Mack', 'Affiliation': 'UC Davis Comprehensive Cancer Center, Sacramento, CA, USA.'}, {'ForeName': 'Mark N', 'Initials': 'MN', 'LastName': 'Stein', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.'}, {'ForeName': 'Maxwell V', 'Initials': 'MV', 'LastName': 'Meng', 'Affiliation': 'University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, A, USA.'}, {'ForeName': 'Primo', 'Initials': 'P', 'LastName': 'Lara', 'Affiliation': 'UC Davis Comprehensive Cancer Center, Sacramento, CA, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Vogelzang', 'Affiliation': 'Comprehensive Cancer Centers of Nevada, Las Vegas, NV, USA.'}, {'ForeName': 'Ian Murchie', 'Initials': 'IM', 'LastName': 'Thompson', 'Affiliation': 'The University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Ryan', 'Affiliation': 'Oregon Health & Science University, OHSU Knight Cancer Institute, Portland, OR, USA.'}]","Kidney cancer (Clifton, Va.)",['10.3233/KCA-180049'] 334,31864178,Long-term outcomes in patients with BRAF V600-mutant metastatic melanoma receiving dabrafenib monotherapy: Analysis from phase 2 and 3 clinical trials.,"BACKGROUND Previous analyses of BREAK-2 and BREAK-3 showed that durable outcomes lasting ≥3 years are achievable with dabrafenib in some patients with BRAF V600-mutant metastatic melanoma (MM); however, additional follow-up is needed to fully characterise the long-term impact of dabrafenib in these patients. METHODS BREAK-2 was a single-arm phase 2 study evaluating dabrafenib in treatment-naive or previously treated BRAF V600E/K-mutant MM. BREAK-3, a randomised (3:1) phase 3 study, assessed dabrafenib versus dacarbazine in previously untreated unresectable or metastatic BRAF V600E-mutant melanoma. Five-year analyses were performed. RESULTS All BREAK-2 patients (N = 92 [V600E, n = 76; V600K, n = 16]) discontinued treatment by the data cutoff. Median follow-up was 13.0 months. In BRAF V600E patients, 5-year progression-free survival (PFS) and overall survival (OS) were 11% and 20%, respectively. Subsequent immunotherapy was received by 22% of patients. In BREAK-3, median follow-up was 17.0 and 12.0 months in the dabrafenib (n = 187) and dacarbazine (n = 63) arms, respectively. Thirty-seven patients (59%) receiving dacarbazine crossed over to dabrafenib following disease progression as per protocol. Five-year PFS was 12% in the dabrafenib arm; all dacarbazine-arm patients progressed or were censored by 5 years. Dabrafenib improved PFS versus dacarbazine, regardless of baseline lactate dehydrogenase levels. Five-year OS rates were 24% and 22% in the dabrafenib and dacarbazine arms, respectively. Subsequent therapy in each arm included anti-CTLA-4 (dabrafenib [24%] and dacarbazine [24%]) and/or anti-PD-1 (8% and 2%) treatment. No new safety signals were observed. CONCLUSIONS AND RELEVANCE These data, representing extended follow-up for dabrafenib monotherapy, demonstrate that durable benefit lasting ≥5 years is achievable in a subset of patients. TRIAL REGISTRATION ClinicalTrials.gov (BREAK-2, NCT01153763; BREAK-3, NCT01227889).",2020,"Five-year OS rates were 24% and 22% in the dabrafenib and dacarbazine arms, respectively.","['previously untreated unresectable or metastatic BRAF V600E-mutant melanoma', 'patients with BRAF V600-mutant metastatic melanoma (MM', 'patients with BRAF V600-mutant metastatic melanoma receiving']","['dabrafenib versus dacarbazine', 'dabrafenib monotherapy', 'dacarbazine', 'dabrafenib in treatment-naive or previously treated BRAF V600E/K-mutant MM', 'dabrafenib']","['baseline lactate dehydrogenase levels', '5-year progression-free survival (PFS) and overall survival (OS']","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}]","[{'cui': 'C3467876', 'cui_str': 'dabrafenib'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement (procedure)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",37.0,0.387792,"Five-year OS rates were 24% and 22% in the dabrafenib and dacarbazine arms, respectively.","[{'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Hauschild', 'Affiliation': 'University Hospital Schleswig-Holstein, Kiel, Germany. Electronic address: ahauschild@dermatology.uni-kiel.de.'}, {'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Istituto Nazionale Tumori IRCCS Fondazione ""G. Pascale,"" Naples, Italy.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'University Hospital of Essen, Essen, Germany; German Cancer Consortium, Heidelberg, Germany.'}, {'ForeName': 'Jean Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Aix-Marseille University, Marseille, France.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Ribas', 'Affiliation': 'UCLA Jonsson Comprehensive Cancer Center, Los Angeles, CA, USA.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Kiecker', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dutriaux', 'Affiliation': 'Hôpital Saint-André, Bordeaux, France.'}, {'ForeName': 'Lev V', 'Initials': 'LV', 'LastName': 'Demidov', 'Affiliation': 'N.N. Blokhin Russian Cancer Research Center, Moscow, Russia.'}, {'ForeName': 'Céleste', 'Initials': 'C', 'LastName': 'Lebbé', 'Affiliation': 'APHP Dermatology and CIC Department, Hôpital Saint-Louis, INSERM U976, University Paris Diderot, Paris, France.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Maria Sklodowska-Curie Institute - Oncology Center, Warsaw, Poland.'}, {'ForeName': 'Christian U', 'Initials': 'CU', 'LastName': 'Blank', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Gutzmer', 'Affiliation': 'Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Millward', 'Affiliation': 'University of Western Australia, Sir Charles Gairdner Hospital, Perth, WA, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kefford', 'Affiliation': 'Westmead Hospital and Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Haas', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': ""D'Amelio"", 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Gasal', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Bijoyesh', 'Initials': 'B', 'LastName': 'Mookerjee', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Chapman', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.10.033'] 335,31748705,Genetic factors associated with elevation of uric acid after treatment with thiazide-like diuretic in patients with essential hypertension.,"We investigated changes in blood pressure (BP) and metabolic adverse effects, especially elevation of uric acid (UA), after treatment with a thiazide-like diuretic (TD) in patients with essential hypertension. Furthermore, the role of genetic factors in the elevation of UA by TD was assessed by a 500 K SNP DNA microarray. The subjects included 126 hypertensive patients (57 women and 69 men, mean age 59 ± 12 years) who registered for the GEANE (Gene Evaluation for ANtihypertensive Effects) study. After one month of the nontreatment period, TD, indapamide, angiotensin II receptor antagonist valsartan, and Ca channel blocker amlodipine were administered to all patients for 3 months each in a randomized crossover manner. BP, renal function, serum UA level, and electrolytes were measured at baseline and at the end of each treatment period. Single nucleotide polymorphisms (SNPs) associated with UA elevation after treatment with indapamide were investigated by a genome-wide association study (GWAS). Indapamide significantly decreased both office and home BP levels. Treatment with indapamide also significantly reduced the estimated glomerular filtration rate and serum potassium and increased serum UA. Patients whose UA level increased more than 1 mg/dl showed significantly higher baseline office SBP and plasma glucose and showed greater decline in renal function compared with those who showed less UA increase (<1 mg/dl). Some SNPs strongly associated with an increase in UA after treatment with indapamide were identified. This study is the first report on SNPs associated with UA elevation after TD treatment. This information may be useful for the prevention of adverse effects after treatment with TD.",2020,Patients whose UA level increased more than 1 mg/dl showed significantly higher baseline office SBP and plasma glucose and showed greater decline in renal function compared with those who showed less UA increase (<1 mg/dl).,"['patients with essential hypertension', '126 hypertensive patients (57 women and 69 men, mean age 59\u2009±\u200912 years) who registered for the GEANE (Gene Evaluation for ANtihypertensive Effects) study']","['thiazide-like diuretic (TD', 'indapamide', 'TD, indapamide, angiotensin II receptor antagonist valsartan, and Ca channel blocker amlodipine', 'thiazide-like diuretic', 'Indapamide']","['estimated glomerular filtration rate and serum potassium and increased serum UA', 'BP, renal function, serum UA level, and electrolytes', 'renal function', 'office and home BP levels', 'UA level', 'UA', 'blood pressure (BP) and metabolic adverse effects, especially elevation of uric acid (UA', 'baseline office SBP and plasma glucose']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085580', 'cui_str': 'Essential Hypertension'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0541746', 'cui_str': 'Thiazides'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C0021186', 'cui_str': 'Indapamide'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II Receptor Blockers'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0439799', 'cui_str': 'Channel (qualifier value)'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}]","[{'cui': 'C3811844'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0013832', 'cui_str': 'Electrolytes'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}]",57.0,0.0446698,Patients whose UA level increased more than 1 mg/dl showed significantly higher baseline office SBP and plasma glucose and showed greater decline in renal function compared with those who showed less UA increase (<1 mg/dl).,"[{'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Ohta', 'Affiliation': 'Division of Hypertension and Nephrology, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Kamide', 'Affiliation': 'Division of Hypertension and Nephrology, National Cerebral and Cardiovascular Center, Osaka, Japan. kamide@sahs.med.osaka-u.ac.jp.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Hanada', 'Affiliation': 'Research Institute, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Shigeto', 'Initials': 'S', 'LastName': 'Morimoto', 'Affiliation': 'Department of Geriatric Medicine, Kanazawa Medical University, Ishishikawa, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Nakahashi', 'Affiliation': 'Department of Geriatric Medicine, Kanazawa Medical University, Ishishikawa, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Takiuchi', 'Affiliation': 'Department of Cardiology, Higashi-Takarazuka Satoh Hospital, Hyogo, Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Ishimitsu', 'Affiliation': 'Department of Hypertension and Cardiorenal Medicine, Dokkyo University School of Medicine, Tochigi, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Tsuchihashi', 'Affiliation': 'Steel Memorial Yawata Hospital, Fukuoka, Japan.'}, {'ForeName': 'Masayoshi', 'Initials': 'M', 'LastName': 'Soma', 'Affiliation': 'Division of General Medicine, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Tomohiro Katsuya', 'Affiliation': 'Department of Geriatric and General Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Geriatric and General Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Rakugi', 'Affiliation': 'Department of Geriatric and General Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Oukura', 'Affiliation': 'Department of Integrated Medicine and Informatics, University Graduate School of Medicine, Ehime, Japan.'}, {'ForeName': 'Jitsuo', 'Initials': 'J', 'LastName': 'Higaki', 'Affiliation': 'Department of Integrated Medicine and Informatics, University Graduate School of Medicine, Ehime, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Matsuura', 'Affiliation': 'Saiseikai Kure Hospital, Hiroshima, Japan.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Shinagawa', 'Affiliation': 'Japanese Red Cross Nagasaki Atomic Bomb Hospital, Nagasaki, Japan.'}, {'ForeName': 'Yosikazu', 'Initials': 'Y', 'LastName': 'Miwa', 'Affiliation': 'Departments of Clinical Pharmacology, Kyushu University Graduate School of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Sasaguri', 'Affiliation': 'Departments of Clinical Pharmacology, Kyushu University Graduate School of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Michiya', 'Initials': 'M', 'LastName': 'Igase', 'Affiliation': 'Geriatric Medicine, Ehime University Graduate School of Medicine, Ehime, Japan.'}, {'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Miki', 'Affiliation': 'Geriatric Medicine, Ehime University Graduate School of Medicine, Ehime, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Takeda', 'Affiliation': 'Kyotokojohokenkai Hospital, Kyoto, Japan.'}, {'ForeName': 'Katsuhiro', 'Initials': 'K', 'LastName': 'Higashiura', 'Affiliation': 'Second Department of Internal Medicine, Sapporo Medical University School of Medicine, Hokkaido, Japan.'}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Shimamoto', 'Affiliation': 'Second Department of Internal Medicine, Sapporo Medical University School of Medicine, Hokkaido, Japan.'}, {'ForeName': 'Ritsuko', 'Initials': 'R', 'LastName': 'Katabuchi', 'Affiliation': 'National Fukuoka-Higashi Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Ueno', 'Affiliation': 'National Fukuoka-Higashi Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Naonaga', 'Initials': 'N', 'LastName': 'Hosomi', 'Affiliation': 'Department of Neurology, Hiroshima University Graduate School of Medicine, Hiroshima, Japan.'}, {'ForeName': 'Johji', 'Initials': 'J', 'LastName': 'Kato', 'Affiliation': 'Frontier Science Research Center, University of Miyazaki, Miyazaki, Japan.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Komai', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Kawasaki Medical School, Okayama, Japan.'}, {'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Kojima', 'Affiliation': 'National Hospital Organization Shizuoka Medical Center, Shizuoka, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Sase', 'Affiliation': 'Clinical Pharmacology, Juntendo University, Tokyo, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Iwashima', 'Affiliation': 'Division of Hypertension and Nephrology, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Fumiki', 'Initials': 'F', 'LastName': 'Yoshihara', 'Affiliation': 'Division of Hypertension and Nephrology, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Horio', 'Affiliation': 'Division of Hypertension and Nephrology, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Satoko', 'Initials': 'S', 'LastName': 'Nakamura', 'Affiliation': 'Division of Hypertension and Nephrology, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Nakahama', 'Affiliation': 'Division of Hypertension and Nephrology, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Miyata', 'Affiliation': 'Research Institute, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Yuhei', 'Initials': 'Y', 'LastName': 'Kawano', 'Affiliation': 'Division of Hypertension and Nephrology, National Cerebral and Cardiovascular Center, Osaka, Japan.'}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-019-0356-x'] 336,31756536,Tandem Autologous-Autologous versus Autologous-Allogeneic Hematopoietic Stem Cell Transplant for Patients with Multiple Myeloma: Long-Term Follow-Up Results from the Blood and Marrow Transplant Clinical Trials Network 0102 Trial.,"Allogeneic hematopoietic cell transplant (HCT) may improve long-term multiple myeloma (MM) control through the graft-versus-myeloma effect. The Blood and Marrow Transplant Clinical Trials Network 0102 trial was a biologic assignment trial comparing tandem autologous transplant (auto-auto) versus autologous followed by reduced-intensity allogeneic (auto-allo) transplant in patients with newly diagnosed MM with standard-risk (n = 625) or high-risk (n = 85; β 2 -microglobulin at diagnosis ≥ 4 mg/dL or deletion of chromosome 13 by conventional karyotyping) disease. Although the initial 3-year analysis showed no difference in progression-free survival (PFS) between arms in either risk group, we hypothesized that long-term follow-up may better capture the impact of the graft-versus-myeloma effect. Median follow-up of survivors was over 10 years. Among standard-risk patients there was no difference in PFS (hazard ratio [HR], 1.11; 95% confidence interval [CI], .93 to 1.35; P = .25) or OS (HR, 1.03; 95% CI, .82 to 1.28; P = .82). The 6-year PFS was 25% in the auto-auto arm versus 22% in the auto-allo arm (P = .32), and 6-year overall survival (OS) was 60% and 59%, respectively (P = .85). In the high-risk group, although there was no statistically significant difference in PFS (HR, .66; 95% CI, .41 to 1.07; P = .07) and OS (HR, 1.01; 95% CI, .60 to 1.71; P = .96), a reduction in 6-year risk of relapse of 77% versus 47% (P = .005) was reflected in better PFS of 13% versus 31% (P = .05) but similar OS, at 47% versus 51% (P = .69). Allogeneic HCT can lead to long-term disease control in patients with high-risk MM and needs to be explored in the context of modern therapy.",2020,"Among standard risk patients there was no difference in PFS (HR 1.11, 95% C.I. 0.93- 1.35, P=0.25) or OS (HR 1.03, 95% C.I. 0.82-1.28, P=0.82).","['Patients with Multiple Myeloma', 'patients with high risk MM', 'patients with newly diagnosed MM with standard (N=625) or high-risk (beta 2 microglobulin at diagnosis ≥ 4 mg/dl or deletion of chromosome 13 by conventional karyotyping) disease (N=85']","['Tandem Autologous-Autologous versus Autologous-Allogeneic Hematopoietic Stem Cell Transplantation', 'tandem autologous transplant (auto-auto) vs. autologous followed by reduced intensity allogeneic (auto-allo) transplantation', 'Allogeneic HCT', 'Allogeneic hematopoietic cell transplantation (HCT']","['6-year PFS', 'progression-free survival (PFS', '6-year risk of relapse', '6-year overall survival (OS', 'PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0201910', 'cui_str': 'Beta-2-microglobulin measurement (procedure)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C1442161', 'cui_str': 'Deletion (morphologic abnormality)'}, {'cui': 'C0008655', 'cui_str': 'Chromosome 13'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0022526', 'cui_str': 'Karyotype Analysis Methods'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}, {'cui': 'C0559189', 'cui_str': 'Autotransplants'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",625.0,0.209154,"Among standard risk patients there was no difference in PFS (HR 1.11, 95% C.I. 0.93- 1.35, P=0.25) or OS (HR 1.03, 95% C.I. 0.82-1.28, P=0.82).","[{'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Giralt', 'Affiliation': 'Adult Bone Marrow Transplant Service, Memorial Sloan Kettering Cancer Center, New York, New York. Electronic address: GiraltS@mskcc.org.'}, {'ForeName': 'Luciano J', 'Initials': 'LJ', 'LastName': 'Costa', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Maloney', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Amrita', 'Initials': 'A', 'LastName': 'Krishnan', 'Affiliation': 'Department of Hematology & Hematopoietic Cell Transplantation, City of Hope, Duarte, California.'}, {'ForeName': 'Mingwei', 'Initials': 'M', 'LastName': 'Fei', 'Affiliation': 'Center for International Blood and Marrow Transplant Research, Department of Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Joseph H', 'Initials': 'JH', 'LastName': 'Antin', 'Affiliation': 'Division of Hematologic Malignancies, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Brunstein', 'Affiliation': 'Division of Hematology, Oncology and Transplantation, Department of Medicine, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Geller', 'Affiliation': 'National Institutes of Health-National Heart, Lung, and Blood Institute Government Agency Partners, Bethesda, Maryland.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Goodman', 'Affiliation': 'VA Tennessee Valley HCS HSCT Program Nashville, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Parameswaran', 'Initials': 'P', 'LastName': 'Hari', 'Affiliation': 'Center for International Blood and Marrow Transplant Research, Department of Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Logan', 'Affiliation': 'Center for International Blood and Marrow Transplant Research, Department of Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin; Division of Biostatistics, Institute for Health and Equity, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lowsky', 'Affiliation': 'Division of Blood and Marrow Transplantation, Stanford University Medical, Stanford, California.'}, {'ForeName': 'Muzaffar H', 'Initials': 'MH', 'LastName': 'Qazilbash', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, Division of Cancer Medicine, M.D. Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Firoozeh', 'Initials': 'F', 'LastName': 'Sahebi', 'Affiliation': 'Department of Hematology & Hematopoietic Cell Transplantation, City of Hope, Duarte, California.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Somlo', 'Affiliation': 'Department of Hematology & Hematopoietic Cell Transplantation, City of Hope, Duarte, California.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Rowley', 'Affiliation': 'John Theurer Cancer Center at Hackensack UMC, Hackensack, New Jersey; Lombardi Comprehensive Cancer Center, MedStar Georgetown University Hospital, Washington, DC.'}, {'ForeName': 'Dan T', 'Initials': 'DT', 'LastName': 'Vogl', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Vesole', 'Affiliation': 'John Theurer Cancer Center at Hackensack UMC, Hackensack, New Jersey.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Pasquini', 'Affiliation': 'Center for International Blood and Marrow Transplant Research, Department of Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Stadtmauer', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania.'}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2019.11.018'] 337,31147972,Intravenous Dexmedetomidine Combined with Ultrasound-Guided Rectus Sheath Block for Open Gastrectomy: a Prospective Randomized Trial.,"PURPOSE To compare the incidences of positive hemodynamic response (HR > 100 beats min -1 or SBP > 160 mmHg) during abdominal exploration and moderate pain after surgery, when using dexmedetomidine infusion and rectus sheath block. METHODS One hundred patients undergoing open gastrectomy were randomized to receive rectus sheath block with ropivacaine (Group B, n = 25), initial loading dose of 0.6 μg kg -1 dexmedetomidine, followed by a continuous infusion of 0.2 μg kg -1  h -1 throughout surgery (Group D, n = 25), both rectus sheath block and dexmedetomidine (Group BD, n = 25), or neither rectus sheath block nor dexmedetomidine (Group C, n = 25). General anesthesia techniques were standardized. HR, SBP, and positive hemodynamic response at peritoneum incision (T PI ), 5 min (T AE-5 ), 10 min (T AE-10 ), and 15 min (T AE-15 ) after the start of abdominal exploration, and incidences of moderate postoperative pain were recorded. RESULTS Positive hemodynamic responses during abdominal exploration were more common in Groups B (82%) and C (74%) than in Groups D (14%) and BD (9%) (all P = 0.000). HR and SBP were lower in Groups D and BD, compared with those in Groups C and B (all P < 0.05). Compared with T PI , HR and SBP increased significantly in Groups B and C during abdominal exploration (all P < 0.05) , but not in Group BD (except HR at T AE-15 ). The incidences of moderate pain in Groups B and BD were noticeably lower than in Groups C and D at 1 h, 2 h, and 6 h after surgery (all P < 0.0083). CONCLUSION Dexmedetomidine infusion combined with rectus sheath block provided more hemodynamic stability during abdominal exploration and better analgesia after surgery.",2020,"RESULTS Positive hemodynamic responses during abdominal exploration were more common in Groups B (82%) and C (74%) than in Groups D (14%) and BD (9%)","['One hundred patients undergoing open gastrectomy', 'Open Gastrectomy']","['initial loading dose of 0.6\xa0μg\xa0kg -1 dexmedetomidine, followed by a continuous infusion of 0.2\xa0μg', 'rectus sheath block and dexmedetomidine', 'Dexmedetomidine infusion combined with rectus sheath block', '1 \xa0h -1 throughout surgery ', 'Dexmedetomidine Combined with Ultrasound-Guided Rectus Sheath Block', 'rectus sheath block nor dexmedetomidine', 'dexmedetomidine infusion and rectus sheath block', 'rectus sheath block with ropivacaine']","['positive hemodynamic response', 'HR, SBP, and positive hemodynamic response at peritoneum incision (T PI ), 5\xa0min (T AE-5 ), 10\xa0min (T AE-10 ), and 15\xa0min (T AE-15 ', 'moderate postoperative pain', 'T PI , HR and SBP', 'hemodynamic stability', 'moderate pain', 'HR and SBP']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C3714444', 'cui_str': 'Loading dose'}, {'cui': 'C4068883', 'cui_str': 'Zero point six'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion (qualifier value)'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0278139', 'cui_str': 'Moderate pain (finding)'}]",100.0,0.0376066,"RESULTS Positive hemodynamic responses during abdominal exploration were more common in Groups B (82%) and C (74%) than in Groups D (14%) and BD (9%)","[{'ForeName': 'Yonghua', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Changzheng Hospital, Second Military Medical University, No. 415 Fengyang Road, Shanghai, 200003, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, Changzheng Hospital, Second Military Medical University, No. 415 Fengyang Road, Shanghai, 200003, China.'}, {'ForeName': 'Jiafeng', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Changhai Hospital, Second Military Medical University, No. 168 Changhai Road, Shanghai, 200433, China.'}, {'ForeName': 'Liye', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Changzheng Hospital, Second Military Medical University, No. 415 Fengyang Road, Shanghai, 200003, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Changzheng Hospital, Second Military Medical University, No. 415 Fengyang Road, Shanghai, 200003, China.'}, {'ForeName': 'Xuerong', 'Initials': 'X', 'LastName': 'Miao', 'Affiliation': 'Department of Anesthesiology, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, No.225 Changhai Road, Shanghai, 200433, China. miaoxuerongdr@126.com.'}, {'ForeName': 'Hongbin', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': 'Department of Anesthesiology, Changzheng Hospital, Second Military Medical University, No. 415 Fengyang Road, Shanghai, 200003, China. jfjczyy@aliyun.com.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-019-04249-2'] 338,31119849,The therapeutic relationship in Cognitive Behaviour Therapy with depressed adolescents: A qualitative study of good-outcome cases.,"OBJECTIVES This paper aimed to explore client experiences of the therapeutic relationship among adolescents with good outcomes after receiving Cognitive Behaviour Therapy (CBT) for moderate to severe depression. DESIGN This was a qualitative study employing Interpretative Phenomenological Analysis (IPA). METHODS As part of a randomized clinical trial, 77 adolescents with moderate to severe depression were interviewed using a semi-structured interview, which was audio-recorded. Five of these interviews, with adolescents aged 14-18 years who completed CBT and had good outcomes, were purposively sampled and analysed using IPA. RESULTS The findings indicated that a positive therapeutic relationship was fostered with therapists who respected the adolescents' autonomy and sense of individuality, while offering experiences of emotional closeness and connection. This was achieved by balancing the dual roles of being 'friendly' and affable, with being a 'professional expert' thereby embodying a collaborative and egalitarian approach. CONCLUSIONS The therapeutic relationship in CBT can help to motivate adolescents to engage with cognitively and emotionally challenging tasks. By providing an understanding of what helps and hinders the development of a positive therapeutic relationship, the current findings offer important insight into how therapists can foster positive relationships with depressed adolescents. This knowledge will make it more likely that adolescents will engage in the treatment process and in turn experience greater therapeutic gains. PRACTITIONER POINTS Offers a detailed phenomenological analysis of what fostered a positive therapeutic relationship in good outcome CBT, and what was experienced as harmful from the adolescents' perspective. Provides support that the therapeutic relationship is crucial in CBT; a respectful and understanding relationship provides a platform for the adolescent to carry out CBT activities and tasks.",2020,"The findings indicated that a positive therapeutic relationship was fostered with therapists who respected the adolescents' autonomy and sense of individuality, while offering experiences of emotional closeness and connection.","['adolescents aged 14-18\xa0years who completed CBT and had good outcomes', '77 adolescents with moderate to severe depression', 'depressed adolescents', 'adolescents with good outcomes after receiving']","['CBT', 'Cognitive Behaviour Therapy', 'Cognitive Behaviour Therapy (CBT']",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]",[],77.0,0.0309412,"The findings indicated that a positive therapeutic relationship was fostered with therapists who respected the adolescents' autonomy and sense of individuality, while offering experiences of emotional closeness and connection.","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Wilmots', 'Affiliation': 'UCL and the Anna Freud National Centre for Children and Families, London, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Midgley', 'Affiliation': 'Child Attachment and Psychological Therapies Research Unit (ChAPTRe), UCL and the Anna Freud National Centre for Children and Families, London, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Thackeray', 'Affiliation': 'UCL and the Anna Freud National Centre for Children and Families, London, UK.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Reynolds', 'Affiliation': 'Charlie Waller Institute, School of Psychology and Clinical Language Sciences, University of Reading, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Loades', 'Affiliation': 'Department of Psychology, University of Bath, UK.'}]",Psychology and psychotherapy,['10.1111/papt.12232'] 339,31742366,A comparative study of the dose-dependent effects of low level and high intensity photobiomodulation (laser) therapy on pain and electrophysiological parameters in patients with carpal tunnel syndrome.,"BACKGROUND Carpal tunnel syndrome (CTS) is a common peripheral nerve disorder of the wrist. Nonsurgical treatments e.g. laser therapy may cause potential beneficial effects. AIM To compare the dose dependent effects of low level laser therapy (LLLT) and high intensity laser therapy (HILT) on pain and electrophysiology studies in patients with CTS. DESIGN Double-blind randomized controlled trial. SETTING Outpatient physiotherapy clinic. POPULATION Ninety-eight participants with CTS, aged between 20 to 60 years, were randomly assigned to five groups. METHODS All participants undertook four standard exercises, with one group serving as exercise-only controls. Patients were randomly allocated to either high or low fluence LLLT or high or low fluence HILT received over 5 sessions. All patients were assessed by visual analogue scale, median compound muscle action potential (CMAP) and sensory nerve conduction studies before and 3 weeks after the interventions. RESULTS VAS was significantly lower in all groups after 3 weeks (P<0.05). CMAP latency decreased in all groups. The interaction of group and time (5×2) was significant for pain (P<0.001), the latency of CMAP (P=0.001) and CMAP amplitude (P=0.02). The interaction of group and time was not significant for the CMAP conduction velocity, sensory nerve latency and amplitude (P>0.05). CONCLUSIONS HILT with a power of 1.6 W and low fluence of 8 J/cm 2 was superior in reduction of pain and improvement of the median motor nerve electrophysiological studies compared to LLLT and exercise-only control groups. CLINICAL REHABILITATION IMPACT LLLT and HILT in conjunction with exercise program are effective in reducing pain and improving median motor nerve conduction studies of the patients with CTS. It seems that high power and low fluence laser therapy is better than LLLT and exercise interventions to treat these patients.",2020,"The interaction of group and time (5×2) was significant for pain (P<0.001), the latency of CMAP (P=0.001) and CMAP amplitude (P=0.02).","['patients with carpal tunnel syndrome', 'Carpal tunnel syndrome (CTS', 'Ninety-eight participants with CTS, aged between 20 to 60 years', 'Outpatient physiotherapy clinic', 'patients with CTS']","['LLLT and exercise interventions', 'low level and high intensity photobiomodulation (laser) therapy', 'low level laser therapy (LLLT) and high intensity laser therapy (HILT', 'high or low fluence LLLT or high or low fluence', 'standard exercises, with one group serving as exercise-only controls']","['CMAP amplitude', 'pain', 'latency of CMAP', 'visual analogue scale, median compound muscle action potential (CMAP) and sensory nerve conduction studies', 'pain and electrophysiology studies', 'CMAP latency', 'pain and electrophysiological parameters', 'VAS', 'CMAP conduction velocity, sensory nerve latency and amplitude (P>0.05']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007286', 'cui_str': 'Amyotrophy, Thenar, Of Carpal Origin'}, {'cui': 'C4319627', 'cui_str': 'Ninety-eight'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C3839152', 'cui_str': 'Physiotherapy clinic'}]","[{'cui': 'C4019433', 'cui_str': 'LLLT'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0279027', 'cui_str': 'Low-Power Laser Therapy'}, {'cui': 'C1955835', 'cui_str': 'Laser Therapy'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0522028', 'cui_str': 'Muscle action potential, function (observable entity)'}, {'cui': 'C0430807', 'cui_str': 'Sensory nerve conduction study (procedure)'}, {'cui': 'C0013865', 'cui_str': 'Electrophysiology'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0234084', 'cui_str': 'Conduction rate of nerve cell and nerve fiber, function (observable entity)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0027740', 'cui_str': 'Nerve structure'}]",98.0,0.106738,"The interaction of group and time (5×2) was significant for pain (P<0.001), the latency of CMAP (P=0.001) and CMAP amplitude (P=0.02).","[{'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Ezzati', 'Affiliation': 'Neuroscience Research Center, Faculty of Medicine, Poorsina Hospital, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'E-Liisa', 'Initials': 'EL', 'LastName': 'Laakso', 'Affiliation': 'School of Allied Health Science, Griffith University, Gold Coast, Australia.'}, {'ForeName': 'Alia', 'Initials': 'A', 'LastName': 'Saberi', 'Affiliation': 'Neuroscience Research Center, Department of Neurology, Poursina Hospital, Guilan University of Medical Sciences, Rasht, Iran - Alia.saberi.1@gmail.com.'}, {'ForeName': 'Shahrokh', 'Initials': 'S', 'LastName': 'Yousefzadeh Chabok', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, Neuroscience Research Center, Poorsina Hospital, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Nasiri', 'Affiliation': 'Faculty of Medicine, Neuroscience Research Center, Poorsina Hospital, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Bakhshayesh Eghbali', 'Affiliation': 'Neuroscience Research Center, Department of Neurology, Poursina Hospital, Guilan University of Medical Sciences, Rasht, Iran.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.19.05835-0'] 340,29924221,Tazarotene gel with narrow-band UVB phototherapy: a synergistic combination in psoriasis.,"BACKGROUND Narrow-band UVB (NB-UVB) has been shown to be one of the most effective treatment modalities for psoriasis. Tazarotene, a known effective anti-psoriatic modality, when combined with NB-UVB may enhance the therapeutic success. OBJECTIVE To study clinical efficacy and safety of combination of NB-UVB with topical tazarotene 0.05% gel in psoriasis. METHOD Thirty patients with plaque psoriasis having symmetrical lesions were enrolled for 12 weeks. All patients were instructed to apply tazarotene gel on target plaque on left side of body once daily. In addition, the whole body was irradiated with NB-UVB twice weekly. Efficacy was assessed by target plaque scoring and number of treatment sessions for clearance. RESULT Our study resulted in 3 key findings: Firstly, therapeutic efficacy of NB-UVB was enhanced by addition of tazarotene. This enhanced efficacy was more apparent in decreasing scaling and thickness as compared to decrease in erythema. Secondly, combination therapy showed faster clearance of target plaques, with reduction in mean number of treatment sessions. Thirdly, mean cumulative NB-UVB dose needed to achieve clearance of target plaques was significantly reduced with combination therapy. STUDY LIMITATIONS The study was not randomized or controlled, but an open-label trial. The study period was relatively short, i.e., 12 weeks, without any follow-up period. CONCLUSION Tazarotene gel significantly enhances the therapeutic efficacy of NB-UVB irradiation with faster clearance and without serious side effects.",2018,Tazarotene gel significantly enhances the therapeutic efficacy of NB-UVB irradiation with faster clearance and without serious side effects.,"['Thirty patients with plaque psoriasis having symmetrical lesions were enrolled for 12 weeks', 'psoriasis']","['NB-UVB with topical tazarotene', 'tazarotene gel', 'Tazarotene', 'Tazarotene gel with narrow-band UVB phototherapy', 'Tazarotene gel']","['Efficacy', 'faster clearance of target plaques', 'therapeutic efficacy of NB-UVB', 'erythema', 'mean cumulative NB-UVB dose needed to achieve clearance of target plaques', 'therapeutic efficacy']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C0332516', 'cui_str': 'Symmetry'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0288792', 'cui_str': 'tazarotene'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C3854333', 'cui_str': 'Narrowing'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0454530', 'cui_str': 'Ultraviolet B therapy (procedure)'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]",30.0,0.0411554,Tazarotene gel significantly enhances the therapeutic efficacy of NB-UVB irradiation with faster clearance and without serious side effects.,"[{'ForeName': 'Surabhi', 'Initials': 'S', 'LastName': 'Dayal', 'Affiliation': 'Department of Dermatology, Venereology and Leprology, Pandit B.D. Sharma Post Graduate Institute of Medical Sciences, Rohtak, Haryana, India.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Kaura', 'Affiliation': 'Civil Hospital, Panchkula, Haryana, India.'}, {'ForeName': 'Priyadarshini', 'Initials': 'P', 'LastName': 'Sahu', 'Affiliation': 'Department of Dermatology, Venereology and Leprology, Pandit B.D. Sharma Post Graduate Institute of Medical Sciences, Rohtak, Haryana, India.'}, {'ForeName': 'Vijay Kumar', 'Initials': 'VK', 'LastName': 'Jain', 'Affiliation': 'Department of Dermatology, Venereology and Leprology, Pandit B.D. Sharma Post Graduate Institute of Medical Sciences, Rohtak, Haryana, India.'}]",Anais brasileiros de dermatologia,['10.1590/abd1806-4841.20186723'] 341,31746819,Balloon Eustachian Tuboplasty Combined With Tympanocentesis Is not Superior to Balloon Eustachian Tuboplasty in Chronic Otitis Media With Effusion-A Randomized Clinical Trial.,"OBJECTIVE Balloon Eustachian tuboplasty (BET) appears to be a promising therapeutic option for Eustachian tube dysfunction. However, data are lacking on its effect in adults with chronic otitis media with effusion (COME) and whether it should be combined with tympanocentesis. The aim of our study was to determine if there is a beneficial effect of BET combined with tympanocentesis compared with BET only and provide data on the effect of BET in adults with COME. STUDY DESIGN Randomized clinical trial. SETTING Tertiary referral hospital. PARTICIPANTS Adults with COME lasting more than 6 months after tympanostomy tube exclusion. Among 40 eligible ears, 30 were randomized to treatment. INTERVENTION BET (group 1) versus BET with concurrent tympanocentesis (group 2). MAIN OUTCOME MEASURES Tympanometry, Valsalva or Toynbee maneuver with tympanometry verification, Eustachian Tube Dysfunction Questionnaire, and pure-tone audiometry. RESULTS A total of 25 patients (14 ears in group 1 and 15 ears in group 2) were included in the analysis. No significant difference in the effect of treatment was found between the groups. When patients were evaluated as one group, after 2, 6, and 12 months, improvement was found in tympanometry in 55, 48, and 48%; in the ability to perform maneuvers in 55, 41, and 41%; in audiometry in 69, 62, and 59%; and in questionnaire scores in 76, 72, and 69%, respectively. CONCLUSIONS There was no beneficial outcome of tympanocentesis performed concurrently with BET and therefore it should not be routinely recommended. The success of therapy appears to be reduced compared with other pathologies caused by Eustachian tube dysfunction.",2020,No significant difference in the effect of treatment was found between the groups.,"['25 patients (14 ears in group 1 and 15 ears in group 2) were included in the analysis', 'adults with chronic otitis media with effusion (COME', 'Adults with COME lasting more than 6 months after tympanostomy tube exclusion', '40 eligible ears, 30 were randomized to treatment', 'Chronic Otitis Media With Effusion', 'Tertiary referral hospital', 'adults with COME']","['Tuboplasty Combined With Tympanocentesis', 'Eustachian Tuboplasty', 'BET', 'Balloon Eustachian tuboplasty (BET', 'Balloon Eustachian', 'BET combined with tympanocentesis', 'BET with concurrent tympanocentesis', 'Balloon']","['questionnaire scores', 'Tympanometry, Valsalva or Toynbee', 'maneuver with tympanometry verification, Eustachian Tube Dysfunction Questionnaire, and pure-tone audiometry', 'ability to perform maneuvers']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013443', 'cui_str': 'Vestibulocochlear Apparatus'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2242816', 'cui_str': 'Chronic non-suppurative otitis media with effusion'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0850121', 'cui_str': 'Ventilation tube'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C3266817', 'cui_str': 'Tympanocentesis'}, {'cui': 'C0198196', 'cui_str': 'Repair of eustachian tube (procedure)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0085853', 'cui_str': 'Tympanometry'}, {'cui': 'C0271468', 'cui_str': 'Eustachian tube disorder (disorder)'}, {'cui': 'C0004292', 'cui_str': 'Audiometry, Pure-Tone'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]",40.0,0.0997188,No significant difference in the effect of treatment was found between the groups.,"[{'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Formánková', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, University Hospital Ostrava.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Formánek', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, University Hospital Ostrava.'}, {'ForeName': 'Lukáš', 'Initials': 'L', 'LastName': 'Školoudík', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, University Hospital Hradec Kralove, Charles University, Faculty of Medicine in Hradec Kralove, Hradec Kralove.'}, {'ForeName': 'Karol', 'Initials': 'K', 'LastName': 'Zeleník', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, University Hospital Ostrava.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Tomášková', 'Affiliation': 'Epidemiological Studies Center, Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Chrobok', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, University Hospital Hradec Kralove, Charles University, Faculty of Medicine in Hradec Kralove, Hradec Kralove.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Komínek', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, University Hospital Ostrava.'}]","Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology",['10.1097/MAO.0000000000002518'] 342,29773662,"Validation of the 16-Gene Recurrence Score in Patients with Locoregional, High-Risk Renal Cell Carcinoma from a Phase III Trial of Adjuvant Sunitinib.","Purpose: Adjuvant sunitinib prolonged disease-free survival (DFS; HR, 0.76) in patients with locoregional high-risk renal cell carcinoma (RCC) in the S-TRAC trial (ClinicalTrials.gov NCT00375674). The 16-gene Recurrence Score (RS) assay was previously developed and validated to estimate risk for disease recurrence in patients with RCC after nephrectomy. This analysis further validated the prognostic value of RS assay in patients from S-TRAC and explored the association of RS results with prediction of sunitinib benefit. Patients and Methods: The analysis was prospectively designed with prespecified genes, algorithm, endpoints, and analytical methods. Primary RCC was available from 212 patients with informed consent; primary analysis focused on patients with T3 RCC. Gene expression was quantitated by RT-PCR. Time to recurrence (TTR), DFS, and renal cancer-specific survival (RCSS) were analyzed using Cox proportional hazards regression. Results: Baseline characteristics were similar between patients with and those without RS results, and between the sunitinib and placebo arms among patients with RS results. RS results predicted TTR, DFS, and RCSS in both arms, with the strongest results observed in the placebo arm. When high versus low RS groups were compared, HR for recurrence was 9.18 [95% confidence interval (CI), 2.15-39.24; P < 0.001) in the placebo arm; interaction of RS results with treatment was not significant. Conclusions: The strong prognostic performance of the 16-gene RS assay was confirmed in S-TRAC, and the RS assay is now supported by level IB evidence. RS results may help identify patients at high risk for recurrence who may derive higher absolute benefit from adjuvant therapy. Clin Cancer Res; 24(18); 4407-15. ©2018 AACR .",2018,"RS results predicted TTR, DFS, and RCSS in both arms, with the strongest results observed in the placebo arm.","['patients with locoregional high-risk renal cell carcinoma (RCC', 'patients with RCC after nephrectomy', '212 patients with informed consent; primary analysis focused on patients with T3 RCC', 'Patients with Locoregional, High-Risk Renal Cell Carcinoma from a Phase III Trial of Adjuvant Sunitinib']",['placebo'],"['Gene expression', 'Time to recurrence (TTR), DFS, and renal cancer-specific survival (RCSS', 'TTR, DFS, and RCSS', '16-gene Recurrence Score (RS) assay', 'HR for recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C0027695', 'cui_str': 'Nephrectomy'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0740457', 'cui_str': 'Cancer of Kidney'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}]",212.0,0.209126,"RS results predicted TTR, DFS, and RCSS in both arms, with the strongest results observed in the placebo arm.","[{'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Cleveland Clinic Taussig Cancer Institute, Cleveland, Ohio. rinib2@ccf.org.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Escudier', 'Affiliation': 'Institut Gustave Roussy (IGR), Department of Medical Oncology, Villejuif, France.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Martini', 'Affiliation': 'Pfizer Inc., La Jolla, California.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Magheli', 'Affiliation': 'Department of Urology, Charité Universitaetsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Christer', 'Initials': 'C', 'LastName': 'Svedman', 'Affiliation': 'Genomic Health Inc., Redwood City, California.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Lopatin', 'Affiliation': 'Genomic Health Inc., Redwood City, California.'}, {'ForeName': 'Dejan', 'Initials': 'D', 'LastName': 'Knezevic', 'Affiliation': 'Genomic Health Inc., Redwood City, California.'}, {'ForeName': 'Audrey D', 'Initials': 'AD', 'LastName': 'Goddard', 'Affiliation': 'Genomic Health Inc., Redwood City, California.'}, {'ForeName': 'Phillip G', 'Initials': 'PG', 'LastName': 'Febbo', 'Affiliation': 'Genomic Health Inc., Redwood City, California.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Pfizer Inc., San Francisco, California.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'Pfizer Inc., La Jolla, California.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Valota', 'Affiliation': 'Pfizer S.r.l., Milan, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Staehler', 'Affiliation': 'Department of Urology, Hospital of Munich, Munich, Germany.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Department of Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Ravaud', 'Affiliation': 'Department of Medical Oncology, Bordeaux University Hospital, Bordeaux, France.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-18-0323'] 343,31735969,Weight Loss Intervention Impact on the Physical Fitness Test Scores of Air Force Service Members.,"INTRODUCTION Overweight and obesity are a major public health concern in the United States, including among active duty military personnel. Approximately 51% of active duty personnel are classified as overweight and 15% are classified as obese. This may impact military readiness. The current study aimed to determine if a weight loss intervention impacted fitness test scores among Air Force personnel. MATERIALS AND METHODS From 2014 to 2016, 204 Air Force members with overweight/obesity were randomized into either a Self-paced or counselor-initiated arm in a weight loss program. Study procedures were approved by the Institutional Review Board of the 59th Medical Wing in San Antonio and were acknowledged by the Institutional Review Board at the University of Tennessee Health Science Center. Fitness test scores from before, during, and after the intervention were used to determine if the intervention resulted in improvements in overall fitness test ratings and scores on individual components of the test. RESULTS Participants who lost at least 5% of their weight had better fitness ratings during the intervention compared to individuals who did not lose 5%. However, in the overall sample, fitness ratings worsened from preintervention to during the intervention, and from during to postintervention. Participants with overweight had better aerobic scores pre- and postintervention as well as better abdominal circumference scores and better fitness test ratings preintervention, during the intervention and postintervention compared to participants with obesity. CONCLUSIONS Behavioral weight management interventions that achieve 5% weight loss may help improve military fitness test ratings.",2020,"Participants with overweight had better aerobic scores pre- and postintervention as well as better abdominal circumference scores and better fitness test ratings preintervention, during the intervention and postintervention compared to participants with obesity. ","['Participants with overweight', 'From 2014 to 2016, 204 Air Force members with overweight/obesity', 'Study procedures were approved by the Institutional Review Board of the 59th Medical Wing in San Antonio and were acknowledged by the Institutional Review Board at the University of Tennessee Health Science Center']","['weight loss intervention', 'Self-paced or counselor-initiated arm in a weight loss program']","['abdominal circumference scores and better fitness test ratings preintervention', 'fitness ratings', 'overall fitness test ratings and scores on individual components of the test', 'military fitness test ratings']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0205540', 'cui_str': 'Approved (qualifier value)'}, {'cui': 'C0086911', 'cui_str': 'Institutional Review Boards'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0039514', 'cui_str': 'Tennessee'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1571885', 'cui_str': 'Counselors'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}]","[{'cui': 'C1300813', 'cui_str': 'Abdominal circumference (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}]",204.0,0.022092,"Participants with overweight had better aerobic scores pre- and postintervention as well as better abdominal circumference scores and better fitness test ratings preintervention, during the intervention and postintervention compared to participants with obesity. ","[{'ForeName': 'Kinsey', 'Initials': 'K', 'LastName': 'Pebley', 'Affiliation': 'Department of Psychology, University of Memphis, Memphis, TN.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Beauvais', 'Affiliation': 'Brooke Army Medical Center, Joint Base San Antonio-Lackland Air Force Base, San Antonio, TX.'}, {'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'Gladney', 'Affiliation': 'Department of Neurology, University of Virginia School of Medicine, Charlottesville, VA.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Kocak', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Robert C Klesges', 'Initials': 'RCK', 'LastName': 'Klesges', 'Affiliation': 'Department of Public Health Sciences, Center for Addiction Prevention Research, University of Virginia School of Medicine, Charlottesville, VA.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Hare', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Phyllis A', 'Initials': 'PA', 'LastName': 'Richey', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Hryshko-Mullen', 'Affiliation': 'Department of Mental Health, Wilford Hall Ambulatory Surgical Center, Joint Base San Antonio-Lackland AFB, San Antonio, TX.'}, {'ForeName': 'G Wayne', 'Initials': 'GW', 'LastName': 'Talcott', 'Affiliation': 'Department of Public Health Sciences, Center for Addiction Prevention Research, University of Virginia School of Medicine, Charlottesville, VA.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Krukowski', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN.'}]",Military medicine,['10.1093/milmed/usz371'] 344,31852287,Intravaginal administration of isosorbide mononitrate for cervical ripening in prolonged pregnancy: a randomised clinical trial.,"Prolonged pregnancies are associated with foetal and neonatal complications. This study was performed to evaluate the efficacy of intravaginal isosorbide mononitrate (IMN) for cervical ripening in prolonged pregnancies. 122 pregnant women were recruited. Women were assigned to 25 µg sublingual misoprostol plus 40 mg isosorbide mononitrate or placebo. Statistical analysis was done using SPSS software (version 23) and T -test, Mann-Whitney and Chi-square test. p  ≤ .05 was considered significant. The mean time between beginning of cervical ripening to Bishop score >6 was significantly shorter in IMN plus misoprostol group when compared to misoprostol plus placebo group ( p  = .02). The mean time from beginning of cervical ripening to the beginning of active phase of Labour was comparable between two groups ( p  = .274). The misoprostol plus IMN group had significantly shorter interval from the beginning of cervical ripening to the time of delivery. Isosorbide mononitrate in combination with misoprostol has a promising effect on cervical ripening and progress in labour.IMPACT STATEMENT What is already known on this subject? Prolonged pregnancy is associated with foetal, neonatal, and maternal complications. Because of these complications, many obstetricians tend toward the induction of prolonged pregnancies to reduce perinatal morbidity and mortality. Isosorbide mononitrate is a nitric oxide donor agent which is used vaginally for cervical ripening in term pregnancies resulting in various outcomes. What do the results of this study add? Isosorbide mononitrate in combination with misoprostol had a greater effect on cervical ripening and progress in labour than misoprostol alone in prolonged pregnancies. What are the implications of these findings for clinical practice and/or further research? According to results of the current study; using isosorbide mononitrate in combination with misoprostol could enhance successful vaginal delivery in prolonged pregnancy. Evaluation of maternal satisfaction by using this protocol is recommended in future studies.",2020,The mean time between beginning of cervical ripening to Bishop score >6 was significantly shorter in IMN plus misoprostol group when compared to misoprostol plus placebo group ( p  = .02).,"['prolonged pregnancy', '122 pregnant women were recruited', 'prolonged pregnancies']","['misoprostol plus IMN', 'IMPACT', 'misoprostol', 'Isosorbide mononitrate', 'isosorbide mononitrate in combination with misoprostol', 'isosorbide mononitrate', 'IMN plus misoprostol', 'sublingual misoprostol plus 40\u2009mg isosorbide mononitrate or placebo', 'misoprostol plus placebo', 'intravaginal isosorbide mononitrate (IMN', 'Isosorbide']","['mean time', 'successful vaginal delivery', 'cervical ripening and progress in labour', 'mean time between beginning of cervical ripening to Bishop score >6', 'perinatal morbidity and mortality']","[{'cui': 'C0032993', 'cui_str': 'Pregnancy, Prolonged'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}]","[{'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0064079', 'cui_str': 'Isosorbide Mononitrate'}, {'cui': 'C4521982', 'cui_str': 'Sublingual'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442122', 'cui_str': 'Intravaginal (qualifier value)'}, {'cui': 'C0022251', 'cui_str': 'Isosorbide'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}, {'cui': 'C0600454', 'cui_str': 'Ripenings, Cervical'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C2225498', 'cui_str': 'Bishop score'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",122.0,0.214301,The mean time between beginning of cervical ripening to Bishop score >6 was significantly shorter in IMN plus misoprostol group when compared to misoprostol plus placebo group ( p  = .02).,"[{'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Mirteimouri', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Pourali', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Najaf Najafi', 'Affiliation': 'Department of Social Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Ghaffarian Omid', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology,['10.1080/01443615.2019.1669546'] 345,30523432,Obesity and mental health improvement following nutritional education focusing on gut microbiota composition in Japanese women: a randomised controlled trial.,"PURPOSE Gut microbiota composition was supposedly related to obesity and psychological factors. We examined the effects of a nutritional education intervention focusing on gut microbiota composition on obesity and psychological factors among obese women. METHODS Forty-four obese Japanese women aged 40 or older were randomly assigned to either an intervention group (n = 22) or control group (n = 22). The intervention consisted of a 20-min dietary lecture and a 10-min counselling session by registered dieticians, every 2 weeks for eight consecutive weeks. Body weight, height, waist circumference, food frequency, and gut microbiota composition were measured, and self-rated health and psychological factors were scored before and after the intervention. RESULTS All participants completed the 8 week program. After the intervention, dietary fibre intake (p < 0.01), frequency of vegetable consumption (p = 0.020), and frequency of milk and milk product consumption (p < 0.01) increased significantly in the intervention group compared with the control group. Body weight and body mass index (BMI; p < 0.001), waist circumference (p < 0.01), and the depression scale score (p < 0.01) decreased significantly, while significant improvements were found in self-rated health (p = 0.045) and microbiome diversity (p < 0.01). CONCLUSION Nutritional education focusing on gut microbiota composition may improve obesity and psychological factors in obese women.",2019,"After the intervention, dietary fibre intake (p < 0.01), frequency of vegetable consumption (p = 0.020), and frequency of milk and milk product consumption (p < 0.01) increased significantly in the intervention group compared with the control group.","['Forty-four obese Japanese women aged 40 or older', 'Japanese women', 'obese women']","['nutritional education', 'nutritional education intervention']","['waist circumference', 'Body weight, height, waist circumference, food frequency, and gut microbiota composition', 'Body weight and body mass index', 'depression scale score', 'frequency of milk and milk product consumption', 'dietary fibre intake', 'self-rated health', 'frequency of vegetable consumption', 'obesity and psychological factors', 'microbiome diversity']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0204934', 'cui_str': 'Nutritional education'}]","[{'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0474451', 'cui_str': 'Dietary fiber intake (observable entity)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0033898', 'cui_str': 'Psychological Factors'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}]",44.0,0.0311124,"After the intervention, dietary fibre intake (p < 0.01), frequency of vegetable consumption (p = 0.020), and frequency of milk and milk product consumption (p < 0.01) increased significantly in the intervention group compared with the control group.","[{'ForeName': 'Mayu', 'Initials': 'M', 'LastName': 'Uemura', 'Affiliation': 'Department of Public Health and Health Systems, Nagoya University Graduate School of Medicine, Nagoya, 466-8550, Japan. mayu-u@med.nagoya-u.ac.jp.'}, {'ForeName': 'Fumikazu', 'Initials': 'F', 'LastName': 'Hayashi', 'Affiliation': 'Department of Epidemiology, School of Medicine, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Ishioka', 'Affiliation': 'Department of Microbiology, School of Medicine, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Kunio', 'Initials': 'K', 'LastName': 'Ihara', 'Affiliation': 'Nagoya University Centre for Gene Research, Nagoya, Japan.'}, {'ForeName': 'Kazushi', 'Initials': 'K', 'LastName': 'Yasuda', 'Affiliation': 'Tosei General Hospital, Seto, Aichi, Japan.'}, {'ForeName': 'Kanako', 'Initials': 'K', 'LastName': 'Okazaki', 'Affiliation': 'Radiation Medical Science Centre for the Fukushima Health Management Survey, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Omata', 'Affiliation': 'Preparing Section for New Faculty of Medical Science/Anatomy, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Suzutani', 'Affiliation': 'Department of Microbiology, School of Medicine, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Hirakawa', 'Affiliation': 'Department of Public Health and Health Systems, Nagoya University Graduate School of Medicine, Nagoya, 466-8550, Japan.'}, {'ForeName': 'Chifa', 'Initials': 'C', 'LastName': 'Chiang', 'Affiliation': 'Department of Public Health and Health Systems, Nagoya University Graduate School of Medicine, Nagoya, 466-8550, Japan.'}, {'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Aoyama', 'Affiliation': 'Department of Public Health and Health Systems, Nagoya University Graduate School of Medicine, Nagoya, 466-8550, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Ohira', 'Affiliation': 'Department of Epidemiology, School of Medicine, Fukushima Medical University, Fukushima, Japan.'}]",European journal of nutrition,['10.1007/s00394-018-1873-0'] 346,31017076,Problem-solving intervention to prevent depression in non-professional caregivers: a randomized controlled trial with 8 years of follow-up.,"BACKGROUND Studies of psychological interventions for the prevention of depression have found significant effects in the short-term, but the long-term efficacy has yet to be determined. This study evaluated the 8-year effect of a randomized controlled trial for indicated prevention of depression in female caregivers. METHODS A total of 173 non-professional female caregivers with subclinical depressive symptoms not meeting criteria for a major depressive episode (MDE) were randomized to either a brief problem-solving intervention (n = 89) or usual-care control group (n = 84). Blinded evaluators conducted an assessment at the 8-year follow-up. The primary outcome was Depression Status, defined by diagnoses of MDE since the 1-year follow-up using the Structured Clinical Interview for the Disorders of the DSM-5. The secondary outcome was current Depressive Symptom Severity. Regression analyses were conducted to evaluate the effect of the intervention on the outcomes. RESULTS There were no significant differences in the Depression Status between the problem-solving (30.3%) and control groups (26.2%) (adjusted OR 1.25, 95% CI -0.58 to 2.69). Depressive Symptom Severity, however, was significantly lower in the problem-solving group compared to the control group at this follow-up, amounting to a small effect size of Cohen's d = 0.39 (adjusted B = -3.32, p = 0.018). CONCLUSIONS This is the first study to assess such a long-term follow-up of intervention of indicated prevention of depression. Results seem to indicate that the protective effect of the intervention became smaller over time during follow-up. Future research should replicate these results.",2020,"There were no significant differences in the Depression Status between the problem-solving (30.3%) and control groups (26.2%) (adjusted OR 1.25, 95% CI -0.58 to 2.69).","['173 non-professional female caregivers with subclinical depressive symptoms not meeting criteria for a major depressive episode (MDE', 'non-professional caregivers', 'female caregivers']","['brief problem-solving intervention (n = 89) or usual-care control group', 'Problem-solving intervention']","['Depressive Symptom Severity', 'Depression Status, defined by diagnoses of MDE since the 1-year follow-up using the Structured Clinical Interview for the Disorders of the DSM-5', 'Depression Status', 'current Depressive Symptom Severity']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0205211', 'cui_str': 'Subclinical (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0199182', 'cui_str': 'Taking health history'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}]",173.0,0.0760938,"There were no significant differences in the Depression Status between the problem-solving (30.3%) and control groups (26.2%) (adjusted OR 1.25, 95% CI -0.58 to 2.69).","[{'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'López', 'Affiliation': 'Department of Clinical Psychology and Psychobiology, University of Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Smit', 'Affiliation': 'Trimbos Institute, Netherlands Institute of Mental Health and Addiction, Utrecht, The Netherlands.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health research institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Otero', 'Affiliation': 'Department of Psychology, University of A Coruña, A Coruña, Spain.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Blanco', 'Affiliation': 'Department of Evolutive and Educational Psychology, University of Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Ángela', 'Initials': 'Á', 'LastName': 'Torres', 'Affiliation': 'Department of Psychiatry, Radiology, Public Health, Nursing and Medicine, University of Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Fernando L', 'Initials': 'FL', 'LastName': 'Vázquez', 'Affiliation': 'Department of Clinical Psychology and Psychobiology, University of Santiago de Compostela, Santiago de Compostela, Spain.'}]",Psychological medicine,['10.1017/S0033291719000916'] 347,27661466,"Changes in plasma levels of oxidized lipoproteins and lipoprotein subfractions with atazanavir-, raltegravir-, darunavir-based initial antiviral therapy and associations with common carotid artery intima-media thickness: ACTG 5260s.","BACKGROUND The role of oxidized lipoproteins (high-density [HDLox] and low-density [LDLox]) and total lipoprotein particle (Lp) number and size in HIV-related cardiovascular disease (CVD) is unclear. The goal of this study was to evaluate changes of these biomarkers and their associations with rate of carotid intima media thickness progression over 3 years (ΔCIMT) in chronic HIV infection. METHODS Prospective study of 234 HIV-infected antiretroviral treatment-naive participants without CVD who were randomized to receive tenofovir-emtricitabine plus atazanavir/ritonavir, darunavir/ritonavir or raltegravir (RAL) and achieved plasma HIV-1 RNA <50 copies/ml by week 24 and thereafter. Biomarker changes over 24, 48 or 96 weeks from baseline and pairwise treatment group comparisons were examined. Associations of these biomarkers with ΔCIMT were analysed with mixed effects linear regression. RESULTS HDLp number increased with both protease inhibitors (PIs) over 48 weeks, while LDLp number declined with RAL; Lp size did not change. Over 96 weeks, normalized HDLox declined with both PIs; LDLox increased in all groups. Few treatment group differences were observed across all biomarkers. Associations between ΔCIMT and oxidized lipoproteins at all time points were not apparent (P≥0.10). There was some evidence of slower ΔCIMT for higher HDLp number (P=0.06) and for lower LDLp number (P=0.08) measured at baseline. CONCLUSIONS Unexpectedly, LDLox increased modestly in all treatment groups after ART initiation. Associations of plasma HDLox and LDLox with ΔCIMT were not apparent. While plasma levels of abnormal lipoproteins have been shown to be associated with CVD outcomes, clear associations with sub-clinical atherosclerosis progression were not apparent in our study.",2017,"There was some evidence of slower ΔCIMT for higher HDLp number (P=0.06) and for lower LDLp number (P=0.08) measured at baseline. ",['234 HIV-infected antiretroviral treatment-naive participants without CVD'],"['oxidized lipoproteins', 'tenofovir-emtricitabine plus atazanavir/ritonavir, darunavir/ritonavir or raltegravir (RAL) and achieved plasma HIV-1 RNA']","['ΔCIMT and oxidized lipoproteins', 'LDLox', 'normalized HDLox', 'plasma levels of oxidized lipoproteins and lipoprotein subfractions with atazanavir-, raltegravir-, darunavir-based initial antiviral therapy', 'plasma HDLox and LDLox with ΔCIMT', 'HDLp number increased with both protease inhibitors (PIs']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1145759', 'cui_str': 'Atazanavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C1435444', 'cui_str': 'darunavir'}, {'cui': 'C1871526', 'cui_str': 'raltegravir'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}]","[{'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1145759', 'cui_str': 'Atazanavir'}, {'cui': 'C1871526', 'cui_str': 'raltegravir'}, {'cui': 'C1435444', 'cui_str': 'darunavir'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0280274', 'cui_str': 'Antiviral therapy (procedure)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1268897', 'cui_str': 'Product containing protease inhibitor'}]",234.0,0.15802,"There was some evidence of slower ΔCIMT for higher HDLp number (P=0.06) and for lower LDLp number (P=0.08) measured at baseline. ","[{'ForeName': 'Theodoros', 'Initials': 'T', 'LastName': 'Kelesidis', 'Affiliation': 'David Geffen School of Medicine at University of California - Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Thuy Tien T', 'Initials': 'TTT', 'LastName': 'Tran', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Todd T', 'Initials': 'TT', 'LastName': 'Brown', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Carlee', 'Initials': 'C', 'LastName': 'Moser', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Ribaudo', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Dube', 'Affiliation': 'Keck School of Medicine at the University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Otto O', 'Initials': 'OO', 'LastName': 'Yang', 'Affiliation': 'David Geffen School of Medicine at University of California - Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Grace A', 'Initials': 'GA', 'LastName': 'McComsey', 'Affiliation': 'Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Stein', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Currier', 'Affiliation': 'David Geffen School of Medicine at University of California - Los Angeles, Los Angeles, CA, USA.'}]",Antiviral therapy,['10.3851/IMP3093'] 348,30535796,"A pilot dose-response study of the acute effects of haskap berry extract (Lonicera caerulea L.) on cognition, mood, and blood pressure in older adults.","PURPOSE Haskap (Lonicera caerulea L. or blue honeysuckle) is a plant native to the low-lying wet areas and mountains of Siberia and northeastern Asia, but is now cultivated in Canada. The dark blue berries are rich in anthocyanins, particularly cyanidin-3-O-glucoside. Previously, anthocyanin-rich fruits have been observed to benefit cognitive performance during the immediate postprandial period following a single acute dose. However, no study has currently examined the potential for haskap berries to influence cognitive performance. Here, we investigate the acute cognitive benefits of an anthocyanin-rich haskap berry extract. METHODS A double-blind, counterbalanced, crossover intervention study compared the acute effects of three separate haskap berry extract doses, containing 100 mg, 200 mg, and 400 mg anthocyanins, with a sugar-matched placebo. Participants were an opportunity sample of 20 older adults, aged 62-81 years. Measures of cognition, mood, and blood pressure were recorded at baseline and 1.5 h postprandially. RESULTS Compared to placebo, the 400 mg dose elicited significantly lower diastolic blood pressure and heart rate. Both 200 mg and 400 mg doses elicited significantly higher word recall, with the 400 mg dose also significantly improving word recognition scores, on an episodic memory task. However, mood, working memory and executive function task results were more equivocal. CONCLUSIONS The findings provide evidence for improvements in episodic memory and blood pressure following acute supplementation with haskap berry extract, with higher doses appearing most effective. The cognitive findings concur with previous literature that suggests episodic memory effects, and not executive function effects, are most prevalent in older adults following anthocyanin-rich berry supplementation. The blood pressure outcome is consistent with a vasodilatory mechanism of action.",2019,"Both 200 mg and 400 mg doses elicited significantly higher word recall, with the 400 mg dose also significantly improving word recognition scores, on an episodic memory task.","['Participants were an opportunity sample of 20 older adults, aged 62-81\xa0years', 'older adults following anthocyanin-rich berry supplementation', 'older adults']","['haskap berry extract (Lonicera caerulea L', 'placebo', 'separate haskap berry extract doses, containing 100\xa0mg, 200\xa0mg, and 400\xa0mg anthocyanins, with a sugar-matched placebo', 'anthocyanin-rich haskap berry extract']","['higher word recall', 'diastolic blood pressure and heart rate', 'word recognition scores', 'episodic memory and blood pressure', 'blood pressure outcome', 'cognition, mood, and blood pressure', 'episodic memory task']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0003161', 'cui_str': 'Anthocyanins'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0005135', 'cui_str': 'Berries'}]","[{'cui': 'C0005135', 'cui_str': 'Berries'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0331065', 'cui_str': 'Honeysuckle'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0003161', 'cui_str': 'Anthocyanins'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",20.0,0.177766,"Both 200 mg and 400 mg doses elicited significantly higher word recall, with the 400 mg dose also significantly improving word recognition scores, on an episodic memory task.","[{'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Bell', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Earley Gate, Whiteknights, Reading, RG6 6AL, UK.'}, {'ForeName': 'Claire M', 'Initials': 'CM', 'LastName': 'Williams', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Earley Gate, Whiteknights, Reading, RG6 6AL, UK. claire.williams@reading.ac.uk.'}]",European journal of nutrition,['10.1007/s00394-018-1877-9'] 349,28650195,Mechanisms underlying mindfulness-based addiction treatment versus cognitive behavioral therapy and usual care for smoking cessation.,"OBJECTIVE To examine cognitive and affective mechanisms underlying mindfulness-based addiction treatment (MBAT) versus cognitive-behavioral therapy (CBT) and usual care (UC) for smoking cessation. METHOD Participants in the parent study from which data were drawn (N = 412; 54.9% female; 48.2% African American, 41.5% non-Latino White, 5.4% Latino, 4.9% other; 57.6% annual income <$30,000) were randomized to MBAT (n = 154), CBT (n = 155), or UC (n = 103). From quit date through 26 weeks postquit, participants completed measures of emotions, craving, dependence, withdrawal, self-efficacy, and attentional bias. Biochemically confirmed 7-day smoking abstinence was assessed at 4 and 26 weeks postquit. Although the parent study did not find a significant treatment effect on abstinence, mixed-effects regression models were conducted to examine treatment effects on hypothesized mechanisms, and indirect effects of treatments on abstinence were tested. RESULTS Participants receiving MBAT perceived greater volitional control over smoking and evidenced lower volatility of anger than participants in both other treatments. However, there were no other significant differences between MBAT and CBT. Compared with those receiving UC, MBAT participants reported lower anxiety, concentration difficulties, craving, and dependence, as well as higher self-efficacy for managing negative affect without smoking. Indirect effects of MBAT versus UC on abstinence occurred through each of these mechanisms. CONCLUSIONS Whereas several differences emerged between MBAT and UC, MBAT and CBT had similar effects on several of the psychosocial mechanisms implicated in tobacco dependence. Results help to shed light on similarities and differences between mindfulness-based and other active smoking cessation treatments. (PsycINFO Database Record",2017,"Whereas several differences emerged between MBAT and UC, MBAT and CBT had similar effects on several of the psychosocial mechanisms implicated in tobacco dependence.","['Participants in the parent study from which data were drawn (N = 412; 54.9% female; 48.2% African American, 41.5% non-Latino White, 5.4% Latino, 4.9% other; 57.6% annual income']","['MBAT versus UC', 'CBT', 'mindfulness-based addiction treatment (MBAT) versus cognitive-behavioral therapy (CBT) and usual care (UC', 'MBAT', 'mindfulness-based addiction treatment versus cognitive behavioral therapy and usual care for smoking cessation']","['lower anxiety, concentration difficulties, craving, and dependence', '7-day smoking abstinence', 'volatility of anger', 'emotions, craving, dependence, withdrawal, self-efficacy, and attentional bias']","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C1959569', 'cui_str': 'Volatility'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C4277667', 'cui_str': 'Attentional Bias'}]",30000.0,0.0216332,"Whereas several differences emerged between MBAT and UC, MBAT and CBT had similar effects on several of the psychosocial mechanisms implicated in tobacco dependence.","[{'ForeName': 'Claire Adams', 'Initials': 'CA', 'LastName': 'Spears', 'Affiliation': 'Division of Health Promotion and Behavior, Georgia State University School of Public Health.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Hedeker', 'Affiliation': 'Department of Public Health Sciences, University of Chicago.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, University of Texas MD Anderson Cancer Center.'}, {'ForeName': 'Cai', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Department of Biostatistics, University of Texas MD Anderson Cancer Center.'}, {'ForeName': 'Natalie K', 'Initials': 'NK', 'LastName': 'Anderson', 'Affiliation': 'Department of Psychology, Catholic University of America.'}, {'ForeName': 'Sean C', 'Initials': 'SC', 'LastName': 'Houchins', 'Affiliation': 'Department of Psychology, Catholic University of America.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Vinci', 'Affiliation': 'Department of Health Outcomes and Behavior, Moffitt Cancer Center.'}, {'ForeName': 'Diana Stewart', 'Initials': 'DS', 'LastName': 'Hoover', 'Affiliation': 'Department of Health Disparities Research, University of Texas MD Anderson Cancer Center.'}, {'ForeName': 'Jennifer Irvin', 'Initials': 'JI', 'LastName': 'Vidrine', 'Affiliation': 'Stephenson Cancer Center, University of Oklahoma Health Sciences Center.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Cinciripini', 'Affiliation': 'Department of Behavioral Science, University of Texas MD Anderson Cancer Center.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Waters', 'Affiliation': 'Department Medical and Clinical Psychology, Uniformed Services University of the Health Sciences.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Wetter', 'Affiliation': 'Department of Population Health Sciences, University of Utah.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000229'] 350,30963185,Evaluation of a new goal-directed training curriculum for point-of-care ultrasound in the emergency department: impact on physician self-confidence and ultrasound skills.,"PURPOSE Developing countries need effective and efficient training curriculum for the point-of-care ultrasound (POCUS) in the emergency department (ED). We have developed a new goal-directed training curriculum focusing on critical POCUS procedures used in ED. METHODS To evaluate the impact of the new POCUS curriculum on ED physicians' performance/self-confidence, we carried out a quasi-experimental trial at ED training center of Peking Union Medical College Hospital, in which we trained two groups of physicians using either traditional curriculum or the new goal-directed curriculum. We measured the confidence in performing Focused Assessment with Sonography in Trauma, thoracic, vascular, ultrasound-guided puncture, echocardiography and undifferentiated shock diagnostic ultrasound at baseline, training completion and 1 month after training. We also measured the performance skills at the time of training completion. The relative value of the new curriculum was evaluated by differences in the confidence and performance measurements, with control for baseline measurements and confounding characteristics in univariate analyses and multivariate linear regression models. RESULTS After training, both groups of trainees reported significantly increased self-confidence in performing POCUS as compared with baseline. Trainees with the new curriculum had statistically significant higher self-confidence increase and performance scores (p < 0.05), e.g., increase in confidence for diagnosis of undifferentiated shock at training completion = 3.14 vs. 1.85, 1 month after training = 2.22 vs. 1.56, for new and traditional curriculum, respectively. The new curriculum also resulted in a higher number of shock POCUS done within 1 month after training: 1.73 vs. 0, and higher overall performance scores: 165 vs. 113. The findings were robust when controlling for imbalanced baseline characteristics in multivariate regression models. CONCLUSION We conclude that a goal-directed, intensive but brief ED POCUS curriculum significantly increases trainee self-confidence, performance, and promote trainees to perform more procedures.",2021,"Trainees with the new curriculum had statistically significant higher self-confidence increase and performance scores (p < 0.05), e.g., increase in confidence for diagnosis of undifferentiated shock at training completion = 3.14 vs. 1.85, 1 month after training = 2.22 vs. 1.56, for new and traditional curriculum, respectively.","[""ED physicians' performance/self-confidence, we carried out a quasi-experimental trial at ED training center of Peking Union Medical College Hospital, in which we trained two groups of physicians using either traditional curriculum or the new goal-directed curriculum""]",[],"['trainee self-confidence, performance', 'self-confidence', 'performance skills', 'confidence for diagnosis of undifferentiated shock', 'self-confidence increase and performance scores']","[{'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0439787', 'cui_str': 'Out (qualifier value)'}, {'cui': 'C0557814', 'cui_str': 'Training center (environment)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}]",[],"[{'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0205618', 'cui_str': 'Undifferentiated (qualifier value)'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.116868,"Trainees with the new curriculum had statistically significant higher self-confidence increase and performance scores (p < 0.05), e.g., increase in confidence for diagnosis of undifferentiated shock at training completion = 3.14 vs. 1.85, 1 month after training = 2.22 vs. 1.56, for new and traditional curriculum, respectively.","[{'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Shi', 'Affiliation': 'Department of Emergency Medicine, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, No. 1 Shuai Fu Yuan, Dong Cheng District, Beijing, 100730, China.'}, {'ForeName': 'Jihai', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Emergency Medicine, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, No. 1 Shuai Fu Yuan, Dong Cheng District, Beijing, 100730, China. liujihai1977@aliyun.com.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Emergency Medicine, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, No. 1 Shuai Fu Yuan, Dong Cheng District, Beijing, 100730, China.'}, {'ForeName': 'Huadong', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Department of Emergency Medicine, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, No. 1 Shuai Fu Yuan, Dong Cheng District, Beijing, 100730, China.'}, {'ForeName': 'Xuezhong', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Emergency Medicine, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, No. 1 Shuai Fu Yuan, Dong Cheng District, Beijing, 100730, China.'}]",European journal of trauma and emergency surgery : official publication of the European Trauma Society,['10.1007/s00068-019-01126-0'] 351,30864532,Home treatment for acute mental healthcare: randomised controlled trial.,"BACKGROUND Home treatment has been proposed as an alternative to acute in-patient care for mentally ill patients. However, there is only moderate evidence in support of home treatment. AIMS To test whether and to what degree home treatment services would enable a reduction (substitution) of hospital use. METHOD A total of 707 consecutively admitted adult patients with a broad spectrum of mental disorders (ICD-10: F2-F6, F8-F9, Z) experiencing crises that necessitated immediate admission to hospital, were randomly allocated to either a service model including a home treatment alternative to hospital care (experimental group) or a conventional service model that lacked a home treatment alternative to in-patient care (control group) (trial registration at ClinicalTrials.gov: NCT02322437). RESULTS The mean number of hospital days per patient within 24 months after the index crisis necessitating hospital admission (primary outcome) was reduced by 30.4% (mean 41.3 v. 59.3, P<0.001) when a home treatment team was available (intention-to-treat analysis). Regarding secondary outcomes, average overall treatment duration (hospital days + home treatment days) per patient (mean 50.4 v. 59.3, P = 0.969) and mean number of hospital admissions per patient (mean 1.86 v. 1.93, P = 0.885) did not differ statistically significantly between the experimental and control groups within 24 months after the index crisis. There were no significant between-group differences regarding clinical and social outcomes (Health of the Nation Outcome Scales: mean 9.9 v. 9.7, P = 0.652) or patient satisfaction with care (Perception of Care questionnaire: mean 0.78 v. 0.80, P = 0.242). CONCLUSIONS Home treatment services can reduce hospital use among severely ill patients in acute crises and seem to result in comparable clinical/social outcomes and patient satisfaction as standard in-patient care.",2020,"There were no significant between-group differences regarding clinical and social outcomes (Health of the Nation Outcome Scales: mean 9.9 v. 9.7, P = 0.652) or patient satisfaction with care (Perception of Care questionnaire: mean 0.78 v. 0.80, P = 0.242). ","['707 consecutively admitted adult patients with a broad spectrum of mental disorders (ICD-10: F2-F6, F8-F9, Z) experiencing crises that necessitated immediate admission to hospital', 'severely ill patients in acute crises', 'mentally ill patients', 'acute mental healthcare']",['service model including a home treatment alternative to hospital care (experimental group) or a conventional service model that lacked a home treatment alternative to in-patient care (control group) (trial registration at ClinicalTrials.gov'],"['average overall treatment duration (hospital days + home treatment days) per patient', 'patient satisfaction with care (Perception of Care questionnaire', 'mean number of hospital admissions', 'mean number of hospital days']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C0231224', 'cui_str': 'Crisis (finding)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0025360', 'cui_str': 'Mentally Ill'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}]","[{'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0017313'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}]",707.0,0.0771763,"There were no significant between-group differences regarding clinical and social outcomes (Health of the Nation Outcome Scales: mean 9.9 v. 9.7, P = 0.652) or patient satisfaction with care (Perception of Care questionnaire: mean 0.78 v. 0.80, P = 0.242). ","[{'ForeName': 'Niklaus', 'Initials': 'N', 'LastName': 'Stulz', 'Affiliation': 'Head of Research, Integrated Psychiatric Services Winterthur - Zurcher Unterland; Senior Researcher (Former Head of Research), Psychiatric Services Aargau; and Research Associate, Department of Psychology, University of Berne, Switzerland.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Wyder', 'Affiliation': 'Research Associate, Psychiatric Services Aargau; and Former PhD Student, Department of Psychology, University of Berne, Switzerland.'}, {'ForeName': 'Lienhard', 'Initials': 'L', 'LastName': 'Maeck', 'Affiliation': 'Senior Physician, Psychiatric Services Aargau, Switzerland.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Hilpert', 'Affiliation': 'Deputy Head of Department, Psychiatric Services Aargau, Switzerland.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Lerzer', 'Affiliation': 'Deputy Head of Nursing Services, Psychiatric Services Aargau, Switzerland.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Zander', 'Affiliation': 'Senior Physician, Psychiatric Services Aargau, Switzerland.'}, {'ForeName': 'Wolfram', 'Initials': 'W', 'LastName': 'Kawohl', 'Affiliation': 'Head of Department, Psychiatric Services Aargau, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Grosse Holtforth', 'Affiliation': 'Associate Professor, Department of Psychology, University of Berne; and Head Researcher, Division of Psychosomatic Medicine, Department of Neurology, Inselspital, University Hospital Berne, Switzerland.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Schnyder', 'Affiliation': 'Emeritus Professor, University of Zurich, Switzerland.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Hepp', 'Affiliation': 'Medical Director, Integrated Psychiatric Services Winterthur - Zurcher Unterland, Switzerland.'}]",The British journal of psychiatry : the journal of mental science,['10.1192/bjp.2019.31'] 352,30448878,Consumption of a dark roast coffee blend reduces DNA damage in humans: results from a 4-week randomised controlled study.,"PURPOSE To determine the DNA protective effects of a standard coffee beverage in comparison to water consumption. METHODS The single-blind, randomised controlled study with parallel design included healthy women (n = 50) and men (n = 50) recruited from the general Central European population. The subjects were randomised in a coffee and a control group, with stratification for sex and body mass index. The study comprised two periods of 4 weeks: a preconditioning period, with daily consumption of at least 500 ml water but no coffee, nor tea, nor any other caffeine-containing product. During the subsequent intervention period the coffee group consumed 500 ml of freshly brewed dark roast coffee blend per day, the control group consumed water instead. On the last day of each period, blood was drawn and analysed by comet assay (single-cell gel electrophoresis) to assess the level of DNA damage (strand breakage). RESULTS At the end of the intervention period the mean level of DNA strand breaks in the coffee group has decreased in comparison to the control group [difference in means 0.23% TI (tail intensity), p = 0.028]. The mean change from baseline (delta value) was - 23% in the coffee group (p = 0.0012). Effects of coffee intake were similar for men and women. During intervention, neither group showed any significant change in body weight or calorie intake. CONCLUSIONS Our results indicate that regular consumption of a dark roast coffee blend has a beneficial protective effect on human DNA integrity in both, men and women.",2019,"At the end of the intervention period the mean level of DNA strand breaks in the coffee group has decreased in comparison to the control group [difference in means 0.23% TI (tail intensity), p = 0.028].","['humans', 'men and women', 'healthy women (n\u2009=\u200950) and men (n\u2009=\u200950) recruited from the general Central European population']","['preconditioning period, with daily consumption of at least 500\xa0ml water but no coffee, nor tea, nor any other caffeine-containing product', 'coffee group consumed 500\xa0ml of freshly brewed dark roast coffee blend per day, the control group consumed water instead']","['mean level of DNA strand breaks', 'body weight or calorie intake', 'level of DNA damage (strand breakage', 'DNA damage']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C1709632', 'cui_str': 'Precondition (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332582', 'cui_str': 'Dark color (qualifier value)'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0301647', 'cui_str': 'Strand breaks (finding)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0012860', 'cui_str': 'DNA Injury'}]",,0.0646729,"At the end of the intervention period the mean level of DNA strand breaks in the coffee group has decreased in comparison to the control group [difference in means 0.23% TI (tail intensity), p = 0.028].","[{'ForeName': 'Dorothea', 'Initials': 'D', 'LastName': 'Schipp', 'Affiliation': 'Statistical Consulting, Pirnaer Str. 1, 01824, Rosenthal-Bielatal, Germany. kontakt@ds-statistik.de.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Tulinska', 'Affiliation': 'Medical Faculty, Slovak Medical University, Bratislava, Slovakia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Sustrova', 'Affiliation': 'Medical Faculty, Slovak Medical University, Bratislava, Slovakia.'}, {'ForeName': 'Aurelia', 'Initials': 'A', 'LastName': 'Liskova', 'Affiliation': 'Medical Faculty, Slovak Medical University, Bratislava, Slovakia.'}, {'ForeName': 'Viera', 'Initials': 'V', 'LastName': 'Spustova', 'Affiliation': 'Medical Faculty, Slovak Medical University, Bratislava, Slovakia.'}, {'ForeName': 'Miroslava', 'Initials': 'M', 'LastName': 'Lehotska Mikusova', 'Affiliation': 'Medical Faculty, Slovak Medical University, Bratislava, Slovakia.'}, {'ForeName': 'Zora', 'Initials': 'Z', 'LastName': 'Krivosikova', 'Affiliation': 'Medical Faculty, Slovak Medical University, Bratislava, Slovakia.'}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Rausova', 'Affiliation': 'Faculty of Public Health, Slovak Medical University, Bratislava, Slovakia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Collins', 'Affiliation': 'Norgenotech AS, Skreia, Norway.'}, {'ForeName': 'Vaineta', 'Initials': 'V', 'LastName': 'Vebraite', 'Affiliation': 'Norgenotech AS, Skreia, Norway.'}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Volkovova', 'Affiliation': 'Norgenotech AS, Skreia, Norway.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Rollerova', 'Affiliation': 'Faculty of Public Health, Slovak Medical University, Bratislava, Slovakia.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Barancokova', 'Affiliation': 'Medical Faculty, Slovak Medical University, Bratislava, Slovakia.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Shaposhnikov', 'Affiliation': 'Norgenotech AS, Skreia, Norway.'}]",European journal of nutrition,['10.1007/s00394-018-1863-2'] 353,31009435,"Acute Effect of Drop-Set, Traditional, and Pyramidal Systems in Resistance Training on Neuromuscular Performance in Trained Adults.","ABSTRACT Costa, BDV, Ferreira, MEC, Gantois, P, Kassiano, W, Paes, ST, de Lima-Júnior, D, Cyrino, ES, and Fortes, LS. Acute effect of drop-set, traditional, and pyramidal systems in resistance training on neuromuscular performance in trained adults. J Strength Cond Res 35(4): 991-996, 2021-The aim of this study was to analyze the acute effects of resistance training (RT) systems on lower- and upper-limb performance in trained adults. Eighteen male young adults with experience in RT aged from 18 to 26 years underwent the 3 experimental conditions (drop-set [DS], decrescent pyramid [DP], and traditional [TR]). The subjects performed 2 exercises (bench press and leg press 45°). In the DS condition, they underwent 2 sets of 10 repetitions at 12RM, followed by 5 additional repetitions with an intensity of 15RM with 6-minute interval rest between sets. In the DP, it was performed 3 sets of 10 repetitions at 10RM, 12RM, and 15RM, respectively, and the rest interval was 3 minutes between sets. In the TR, the subjects performed 3 sets of 10 repetitions at 12RM with 3 minutes of rest between sets. Countermovement jump, peak power (Wpeak), and force (Fpeak) in the bench press were evaluated in the baseline, before, and 30 minutes after the experimental sessions. Countermovement jump performance decreased significantly only after the DS and DP conditions (-6.7 and -1.9%, respectively). The groups were significantly different in the post-intervention; the DS condition presented lower values when compared with the DP (p = 0.01) and TR (p = 0.001). According to Fpeak and Wpeak, only DS condition significantly decreased the performance (-3.8 and -4.1%, respectively). The results indicate the DS and DP conditions impair the neuromuscular performance of the lower limbs, whereas for upper limbs, only DS condition negatively affect upper-limb performance.",2021,The groups were significantly different in the post-intervention; the DS condition presented lower values when compared with the DP (p = 0.01) and TR (p = 0.001).,"['trained adults', 'Trained Adults', 'Eighteen male young adults with experience in RT aged from 18 to 26 years underwent the 3 experimental conditions (drop-set [DS], decrescent pyramid [DP], and traditional [TR']","['J Strength Cond Res XX(X', 'Drop-Set, Traditional, and Pyramidal Systems in Resistance Training', 'resistance training (RT) systems']","['Countermovement jump, peak power (Wpeak), and force (Fpeak', 'Countermovement jump performance', 'lower- and upper-limb performance', 'Costa, BDV, Ferreira, MEC, Gantois, P, Kassiano, W, Paes, ST, de Lima-Júnior, D, Cyrino, ES, and Fortes, LS', 'neuromuscular performance of the lower limbs, whereas for upper limbs, only DS condition negatively affect upper-limb performance', 'neuromuscular performance']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0262324', 'cui_str': 'Pyramid of medulla oblongata (body structure)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}]","[{'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0228060', 'cui_str': 'Pyramidal system structure'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}]",18.0,0.0250946,The groups were significantly different in the post-intervention; the DS condition presented lower values when compared with the DP (p = 0.01) and TR (p = 0.001).,"[{'ForeName': 'Bruna Daniella de Vasconcelos', 'Initials': 'BDV', 'LastName': 'Costa', 'Affiliation': 'Graduate Program in Physical Education of Federal University of Pernambuco (UFPE), Pernambuco, Brazil.'}, {'ForeName': 'Maria Elisa Caputo', 'Initials': 'MEC', 'LastName': 'Ferreira', 'Affiliation': 'Graduate Program in Physical Education of Federal University of Juiz de Fora (UFJF), Juiz de Fora, Brazil.'}, {'ForeName': 'Petrus', 'Initials': 'P', 'LastName': 'Gantois', 'Affiliation': 'Graduate Program in Physical Education of Federal University of Paraíba (UFPB), Paraíba, Brazil.'}, {'ForeName': 'Witalo', 'Initials': 'W', 'LastName': 'Kassiano', 'Affiliation': 'Federal University of Ceará (UFC), Ceará, Brazil; and.'}, {'ForeName': 'Santiago T', 'Initials': 'ST', 'LastName': 'Paes', 'Affiliation': 'Graduate Program in Physical Education of Federal University of Juiz de Fora (UFJF), Juiz de Fora, Brazil.'}, {'ForeName': 'Dalton', 'Initials': 'D', 'LastName': 'de Lima-Júnior', 'Affiliation': 'Graduate Program in Physical Education of Federal University of Pernambuco (UFPE), Pernambuco, Brazil.'}, {'ForeName': 'Edilson S', 'Initials': 'ES', 'LastName': 'Cyrino', 'Affiliation': 'Graduate Program in Physical Education of State University of Londrina (UEL), Londrina, Brazil.'}, {'ForeName': 'Leonardo de Sousa', 'Initials': 'LS', 'LastName': 'Fortes', 'Affiliation': 'Graduate Program in Physical Education of Federal University of Paraíba (UFPB), Paraíba, Brazil.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003150'] 354,31736460,"An assessment of rapamycin for weakening binge-eating memories via reconsolidation: a pre-registered, double-blind randomised placebo-controlled experimental study.","BACKGROUND Maladaptive learning linking environmental food cues to high-palatability food reward plays a central role in overconsumption in obesity and binge eating disorders. The process of memory reconsolidation offers a mechanism to weaken such learning, potentially ameliorating over-eating behaviour. Here we investigated whether putatively interfering with synaptic plasticity using the mammalian target of rapamycin (mTOR) inhibitor, rapamycin, could weaken retrieved chocolate reward memories through blockade of reconsolidation. METHODS Seventy five healthy volunteers with a tendency to binge eat chocolate were randomised to retrieve chocolate reward memory under 10 mg rapamycin (RET + RAP, active condition), or placebo (RET + PBO), or they received 10 mg rapamycin without subsequent retrieval (NO RET + RAP). Indices of chocolate reward memory strength were assessed one week pre and post manipulation and at one month follow-up. RESULTS Contrary to hypotheses, the RET + RAP group did not show any greater reduction than control groups on indices of motivational salience of chocolate cues, motivation to consume chocolate or liking of chocolate. Mild evidence of improvement in the RET + RAP group was found, but this was limited to reduced chocolate binge episodes and improved healthy food choices. CONCLUSIONS We did not find convincing evidence of comprehensive naturalistic chocolate reward memory reconsolidation blockade by rapamycin. The effects on chocolate bingeing and food choices may warrant further investigation. These limited positive findings may be attributable to insufficient interference with mTOR signalling with 10 mg rapamycin, or failure to destabilise chocolate memories during retrieval.",2021,"Contrary to hypotheses, the RET + RAP group did not show any greater reduction than control groups on indices of motivational salience of chocolate cues, motivation to consume chocolate or liking of chocolate.",['Seventy five healthy volunteers with a tendency to binge eat chocolate'],"['mTOR) inhibitor, rapamycin', 'retrieve chocolate reward memory under 10 mg rapamycin (RET + RAP, active condition), or placebo (RET + PBO), or they received 10 mg rapamycin without subsequent retrieval (NO RET + RAP', 'RET + RAP', 'placebo', 'rapamycin']","['chocolate binge episodes', 'motivational salience of chocolate cues, motivation to consume chocolate or liking of chocolate']","[{'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0008299', 'cui_str': 'Chocolate'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0008299', 'cui_str': 'Chocolate'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0543431', 'cui_str': 'ret (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332288', 'cui_str': 'Without (attribute)'}]","[{'cui': 'C0008299', 'cui_str': 'Chocolate'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",75.0,0.200643,"Contrary to hypotheses, the RET + RAP group did not show any greater reduction than control groups on indices of motivational salience of chocolate cues, motivation to consume chocolate or liking of chocolate.","[{'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Walsh', 'Affiliation': 'Clinical, Educational and Health Psychology, University College London, Gower Street, London, WC1E 6BT.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Iskandar', 'Affiliation': 'University College Hospital and University College Hospital at Westmoreland Street, London, UK.'}, {'ForeName': 'Sunjeev K', 'Initials': 'SK', 'LastName': 'Kamboj', 'Affiliation': 'Clinical, Educational and Health Psychology, University College London, Gower Street, London, WC1E 6BT.'}, {'ForeName': 'Ravi K', 'Initials': 'RK', 'LastName': 'Das', 'Affiliation': 'Clinical, Educational and Health Psychology, University College London, Gower Street, London, WC1E 6BT.'}]",Psychological medicine,['10.1017/S003329171900312X'] 355,31022103,Effects of Different Hand Widths on Plyometric Push-up Performance.,"ABSTRACT Nichols, IA and Szivak, TK. Effects of different hand widths on plyometric push-up performance. J Strength Cond Res 35(2S): S80-S83, 2021-The purpose of this study was to investigate the effects of hand width placement during the performance of plyometric push-ups. Ten male subjects (age: 24.14 ± 2.79 years, height: 178.14 ± 5.21 cm, and body mass: 91.55 ± 6.04 kg) performed 2 plyometric push-ups at 120, 150, and 170% of the subject's biacromial width (6 total push-ups) in a randomized order. Height (H), peak force (pF), peak power (pP), and rate of power development data were collected using a force plate. One-way repeated-measures analysis of variance showed no significant differences in performance measures across all hand widths. A secondary analysis using a mixed-effects linear regression model was performed due to the small sample size. Regression analysis showed a significant difference in pF (p < 0.05) between 120 and 170% hand widths. Study results suggest that although upper-body (UB) power output seems to be similar across varying hand widths, UB force development (pF) may be significantly affected by hand width during the plyometric push-up. Study results suggest that hand-width placement may impact plyometric performance measures and should be considered if the plyometric push-up is used to assess an individual's UB power. To the best of authors' knowledge, this is the first study to investigate the effects of varying hand widths on plyometric push-up performance.",2021,Regression analysis showed a significant difference in pF (p < 0.05) between 120 and 170% hand widths.,"['Ten male subjects (age: 24.14 ± 2.79 years, height: 178.14 ± 5.21 cm, and body mass: 91.55 ± 6.04 kg) performed 2']","['J Strength Cond Res XX(X', 'hand width placement', 'plyometric push-ups']","['Height (H), peak force (pF), peak power (pP), and rate of power development data', 'pF']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1719958', 'cui_str': 'Push'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}]",10.0,0.0272034,Regression analysis showed a significant difference in pF (p < 0.05) between 120 and 170% hand widths.,"[{'ForeName': 'Isaac A', 'Initials': 'IA', 'LastName': 'Nichols', 'Affiliation': 'Department of Exercise and Rehabilitation Sciences, School of Health Sciences, Merrimack College, North Andover, Massachusetts.'}, {'ForeName': 'Tunde K', 'Initials': 'TK', 'LastName': 'Szivak', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003155'] 356,30661255,The Nonsteroidal Farnesoid X Receptor Agonist Cilofexor (GS-9674) Improves Markers of Cholestasis and Liver Injury in Patients With Primary Sclerosing Cholangitis.,"Primary sclerosing cholangitis (PSC) represents a major unmet medical need. In a phase II double-blind, placebo-controlled study, we tested the safety and efficacy of cilofexor (formerly GS-9674), a nonsteroidal farnesoid X receptor agonist in patients without cirrhosis with large-duct PSC. Patients were randomized to receive cilofexor 100 mg (n = 22), 30 mg (n = 20), or placebo (n = 10) orally once daily for 12 weeks. All patients had serum alkaline phosphatase (ALP) > 1.67 × upper limit of normal and total bilirubin ≤ 2 mg/dL at baseline. Safety, tolerability, pharmacodynamic effects of cilofexor (serum C4 [7α-hydroxy-4-cholesten-3-one] and bile acids), and changes in liver biochemistry and serum fibrosis markers were evaluated. Overall, 52 patients were randomized (median age 43 years, 58% male, 60% with inflammatory bowel disease, 46% on ursodeoxycholic acid). Baseline median serum ALP and bilirubin were 348 U/L (interquartile range 288-439) and 0.7 mg/dL (0.5-1.0), respectively. Dose-dependent reductions in liver biochemistry were observed. At week 12, cilofexor 100 mg led to significant reductions in serum ALP (median reduction -21%; P = 0.029 versus placebo), gamma-glutamyl transferase (-30%; P < 0.001), alanine aminotransferase (ALT) (-49%; P = 0.009), and aspartate aminotransferase (-42%; P = 0.019). Cilofexor reduced serum C4 compared with placebo; reductions in bile acids were greatest with 100 mg. Relative reductions in ALP were similar between ursodeoxycholic acid-treated and untreated patients. At week 12, cilofexor-treated patients with a 25% or more relative reduction in ALP had greater reductions in serum alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, tissue inhibitor of metalloproteinase 1, C-reactive protein, and bile acids than nonresponders. Adverse events were similar between cilofexor and placebo-treated patients. Rates of grade 2 or 3 pruritus were 14% with 100 mg, 20% with 30 mg, and 40% with placebo. Conclusion: In this 12-week, randomized, placebo-controlled study, cilofexor was well tolerated and led to significant improvements in liver biochemistries and markers of cholestasis in patients with PSC.",2019,All patients had serum alkaline phosphatase (ALP) > 1.67 × upper limit of normal and total bilirubin ≤ 2 mg/dL at baseline.,"['52 patients were randomized (median age 43 years, 58% male, 60% with inflammatory bowel disease, 46% on ursodeoxycholic acid', 'patients without cirrhosis with large-duct PSC', 'Patients With Primary Sclerosing Cholangitis', 'patients with PSC']","['Nonsteroidal Farnesoid X Receptor Agonist Cilofexor (GS-9674', 'nonsteroidal farnesoid X receptor agonist', 'placebo', 'cilofexor', 'cilofexor (formerly GS-9674', 'ursodeoxycholic acid']","['gamma-glutamyl transferase', 'safety and efficacy', 'aspartate aminotransferase', 'Adverse events', 'serum alkaline phosphatase (ALP', 'bile acids', 'liver biochemistry', 'liver biochemistries and markers of cholestasis', 'ALP', 'Baseline median serum ALP and bilirubin', 'Cholestasis and Liver Injury', 'serum ALP', 'alanine aminotransferase (ALT', 'Rates of grade 2 or 3 pruritus', 'Safety, tolerability, pharmacodynamic effects of cilofexor (serum C4 [7α-hydroxy-4-cholesten-3-one] and bile acids), and changes in liver biochemistry and serum fibrosis markers', 'serum alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, tissue inhibitor of metalloproteinase 1, C-reactive protein, and bile acids']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0042105', 'cui_str': 'ursodesoxycholic acid'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0687028', 'cui_str': 'Duct (organ) structure'}, {'cui': 'C0566602', 'cui_str': 'Primary sclerosing cholangitis (disorder)'}]","[{'cui': 'C4707406', 'cui_str': 'Product containing farnesoid X receptor agonist'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042105', 'cui_str': 'ursodesoxycholic acid'}]","[{'cui': 'C0017040', 'cui_str': 'gammaglutamyltransferase'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036776', 'cui_str': 'Serum alkaline phosphatase measurement'}, {'cui': 'C0005390', 'cui_str': 'Bile Acids'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0008370', 'cui_str': 'Bile Duct Obstruction'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin IX alpha'}, {'cui': 'C0160390', 'cui_str': 'Injury of liver (disorder)'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0055520', 'cui_str': 'cholest-4-en-3-one'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0145947', 'cui_str': 'TIMP-1'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",52.0,0.370652,All patients had serum alkaline phosphatase (ALP) > 1.67 × upper limit of normal and total bilirubin ≤ 2 mg/dL at baseline.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Trauner', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Aliya', 'Initials': 'A', 'LastName': 'Gulamhusein', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Hameed', 'Affiliation': 'University of California, San Francisco School of Medicine, San Francisco, CA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Caldwell', 'Affiliation': 'University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Mitchell L', 'Initials': 'ML', 'LastName': 'Shiffman', 'Affiliation': 'Bon Secours Liver Institute, Richmond, VA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Landis', 'Affiliation': 'University of Washington School of Medicine, Seattle, WA.'}, {'ForeName': 'Bertus', 'Initials': 'B', 'LastName': 'Eksteen', 'Affiliation': 'Aspen Woods Clinic, Calgary, AB, Canada.'}, {'ForeName': 'Kosh', 'Initials': 'K', 'LastName': 'Agarwal', 'Affiliation': ""King's College, London, UK.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Muir', 'Affiliation': 'Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Rushbrook', 'Affiliation': 'Norfolk and Norwich University Hospital, Norfolk, UK.'}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Jen-Chieh', 'Initials': 'JC', 'LastName': 'Chuang', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Billin', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Chuhan', 'Initials': 'C', 'LastName': 'Chung', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'G Mani', 'Initials': 'GM', 'LastName': 'Subramanian', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Myers', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Bowlus', 'Affiliation': 'University of California Davis, Davis, CA.'}, {'ForeName': 'Kris V', 'Initials': 'KV', 'LastName': 'Kowdley', 'Affiliation': 'Liver Care Network and Organ Care Research, Swedish Medical Center, Seattle, WA.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30509'] 357,32083368,Dronedarone treatment following cardioversion in patients with atrial fibrillation/flutter: A post hoc analysis of the EURIDIS and ADONIS trials.,"INTRODUCTION The phase 3 EURIDIS and ADONIS studies evaluated dronedarone for atrial fibrillation (AF)/atrial flutter (AFL) recurrence in patients with nonpermanent AF. Here we assessed whether patient characteristics and/or treatment outcomes in these studies differed based on the need for cardioversion before randomization. METHODS Time to adjudicated first AF/AFL recurrence, symptomatic recurrence, cardiovascular hospitalization/death, and AF hospitalization, and safety were assessed by cardioversion status. RESULTS Of 1237 patients randomized (2:1 dronedarone:placebo), 364 required baseline cardioversion (dronedarone 243, placebo 121). Patients requiring cardioversion had a greater prevalence of cardiovascular comorbidities and shorter times to first AF/AFL recurrence compared with those not requiring cardioversion. Dronedarone was associated with longer median time to first AF/AFL recurrence vs placebo regardless of cardioversion status (cardioversion: 50 vs 15 days, hazard ratio [HR] 0.76; 95% confidence interval [CI], 0.59-0.97; P = .02; non-cardioversion: 150 vs 77 days, HR 0.76; 95% CI, 0.64-0.90; P < .01). Dronedarone was similarly associated with prolonged median time to symptomatic recurrence vs placebo in the cardioversion (347 vs 87 days, HR 0.65; 95% CI, 0.49-0.87) and non-cardioversion (288 vs 120 days, HR 0.74; 95% CI, 0.62-0.90) populations. Risk of cardiovascular hospitalization/death and first AF hospitalization was lower with dronedarone vs placebo regardless of cardioversion status, but differences were not statistically significant. The safety of dronedarone was similar in both groups. CONCLUSION Patients requiring baseline cardioversion represent a distinct population, having more underlying cardiovascular disease and experiencing a shorter time to AF/AFL recurrences. Dronedarone was associated with improved efficacy vs placebo regardless of cardioversion status.",2020,"Dronedarone was associated with longer median time to first AF/AFL recurrence vs placebo regardless of cardioversion status (cardioversion: 50 vs 15 days, hazard ratio [HR]","['patients with non-permanent AF', '1237 patients randomized (2:1', 'patients with atrial fibrillation']","['dronedarone:placebo', 'placebo', 'baseline cardioversion (dronedarone 243, placebo', 'dronedarone', 'Dronedarone']","['cardiovascular comorbidities and shorter times to first AF/AFL recurrence', 'prolonged median time to symptomatic recurrence', 'hazard ratio [HR', 'atrial fibrillation (AF)/atrial flutter (AFL) recurrence', 'longer median time to first AF/AFL recurrence', 'AFL recurrence, symptomatic recurrence, cardiovascular hospitalization/death, and AF hospitalization, and safety', 'Risk of cardiovascular hospitalization/death and first AF hospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]","[{'cui': 'C0766326', 'cui_str': 'dronedarone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013778', 'cui_str': 'Electrical Cardioversion'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",1237.0,0.281226,"Dronedarone was associated with longer median time to first AF/AFL recurrence vs placebo regardless of cardioversion status (cardioversion: 50 vs 15 days, hazard ratio [HR]","[{'ForeName': 'Munveer', 'Initials': 'M', 'LastName': 'Thind', 'Affiliation': 'Division of Cardiovascular Medicine, Lankenau Heart Institute, Wynnewood, Pennsylvania.'}, {'ForeName': 'Harry J', 'Initials': 'HJ', 'LastName': 'Crijns', 'Affiliation': 'Department of Cardiology, Maastricht University Medical Center and CARIM, Maastricht, Netherlands.'}, {'ForeName': 'Gerald V', 'Initials': 'GV', 'LastName': 'Naccarelli', 'Affiliation': 'Department of Medicine, Division of Cardiology, Penn State University College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Reiffel', 'Affiliation': 'Department of Medicine, Division of Cardiology, Vagelos College of Physicians and Surgeons, Columbia University, New York, New York.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Corp Dit Genti', 'Affiliation': 'Sanofi-Aventis, Paris, France.'}, {'ForeName': 'Mattias', 'Initials': 'M', 'LastName': 'Wieloch', 'Affiliation': 'Sanofi-Aventis, Paris, France.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Koren', 'Affiliation': 'Sanofi US Inc, Bridgewater, New Jersey.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Kowey', 'Affiliation': 'Division of Cardiovascular Medicine, Lankenau Heart Institute, Wynnewood, Pennsylvania.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.14405'] 358,30460609,Effects of vitamin D supplementation on androgens in men with low testosterone levels: a randomized controlled trial.,"PURPOSE It has been hypothesized that vitamin D is associated with androgen levels in men. We, therefore, aimed to evaluate whether vitamin D supplementation increases serum total testosterone (TT) levels in men with low TT levels at baseline. METHODS The Graz Vitamin D&TT-RCT is a single-center, double-blind, randomized placebo-controlled trial conducted between March 2013 and November 2017 at the endocrine outpatient clinic at the Medical University of Graz, Austria. One-hundred healthy men with serum TT levels < 10.4 nmol/l and 25-hydroxyvitamin D [25(OH)D] levels < 75 nmol/l participated in the trial. Subjects were randomized to receive 20,000 IU of vitamin D3/week (n = 50) or placebo (n = 50) for 12 weeks. Primary outcome was TT measured using mass spectrometry. Secondary outcomes were free testosterone, free androgen index, sex hormone-binding globulin, estradiol, follicle-stimulating hormone, luteinizing hormone, metabolic characteristics, and body composition. RESULTS Ninety-four men [mean age and 25(OH)D: 47 (± 12) years and 56.3 (± 18.3) nmol/l, respectively] completed the study. We found no significant treatment effect on serum TT or on the remaining secondary outcome variables. CONCLUSION Vitamin D treatment had no effect on serum TT levels in middle-aged healthy men with low TT levels.",2019,"We found no significant treatment effect on serum TT or on the remaining secondary outcome variables. ","['men with low testosterone levels', 'middle-aged healthy men with low TT levels', 'One-hundred healthy men with serum TT levels <\u200910.4\xa0nmol/l and 25-hydroxyvitamin D [25(OH)D] levels\u2009<\u200975\xa0nmol/l participated in the trial', 'men with low TT levels at baseline', 'men', 'Ninety-four men [mean age and 25(OH)D: 47 (±\u200912) years and 56.3 (±\u200918.3) nmol/l, respectively] completed the study', 'March 2013 and November 2017\xa0at the endocrine outpatient clinic at the Medical University of Graz, Austria']","['vitamin D', 'vitamin D supplementation', 'placebo', 'Vitamin D', 'vitamin D3/week (n\u2009=\u200950) or placebo']","['serum TT levels', 'serum total testosterone (TT) levels', 'free testosterone, free androgen index, sex hormone-binding globulin, estradiol, follicle-stimulating hormone, luteinizing hormone, metabolic characteristics, and body composition', 'TT measured using mass spectrometry']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1295654', 'cui_str': 'Decreased testosterone level'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439282', 'cui_str': 'nM'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0004348', 'cui_str': 'Austria'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0443483', 'cui_str': 'Free testosterone (substance)'}, {'cui': 'C0428629', 'cui_str': 'Free androgen index measurement'}, {'cui': 'C0202218', 'cui_str': 'Sex hormone binding globulin measurement (procedure)'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0023607', 'cui_str': 'Luteinizing Hormone'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0037813', 'cui_str': 'Spectrum Analysis, Mass'}]",100.0,0.779037,"We found no significant treatment effect on serum TT or on the remaining secondary outcome variables. ","[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Lerchbaum', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria. Elisabeth.lerchbaum@medunigraz.at.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Trummer', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Theiler-Schwetz', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Kollmann', 'Affiliation': 'Division of Gynecological Endocrinology and Reproductive Medicine, Department of Obstetrics and Gynecology, Medical University of Graz, Auenbruggerplatz 14, 8036, Graz, Austria.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Wölfler', 'Affiliation': 'Division of Gynecological Endocrinology and Reproductive Medicine, Department of Obstetrics and Gynecology, Medical University of Graz, Auenbruggerplatz 14, 8036, Graz, Austria.'}, {'ForeName': 'Annemieke C', 'Initials': 'AC', 'LastName': 'Heijboer', 'Affiliation': 'Endocrine Laboratory, Department of Clinical Chemistry, VU University Medical Center, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Pilz', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Obermayer-Pietsch', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria.'}]",European journal of nutrition,['10.1007/s00394-018-1858-z'] 359,30689402,Lenvatinib plus everolimus or pembrolizumab versus sunitinib in advanced renal cell carcinoma: study design and rationale.,"AIM Lenvatinib plus everolimus is approved for the treatment of advanced renal cell carcinoma (RCC) after one prior vascular endothelial growth factor-targeted therapy. Lenvatinib plus pembrolizumab demonstrated promising antitumor activity in a Phase I/II trial of RCC. METHODS We describe the rationale and design of the CLEAR study, a three-arm Phase III trial comparing lenvatinib plus everolimus and lenvatinib plus pembrolizumab versus sunitinib monotherapy for first-line treatment of RCC. Eligible patients must have advanced clear cell RCC and must not have received any prior systemic anticancer therapy. The primary end point is progression-free survival; secondary end points include objective response rate, overall survival, safety, health-related quality of life and pharmacokinetics. Biomarker evaluations are included as exploratory end points.",2019,"Lenvatinib plus pembrolizumab demonstrated promising antitumor activity in a Phase I/II trial of RCC. ","['advanced renal cell carcinoma (RCC', 'Eligible patients must have advanced clear cell RCC and must not have received any prior systemic anticancer therapy', 'advanced renal cell carcinoma']","['Lenvatinib plus everolimus or pembrolizumab versus sunitinib', 'Lenvatinib plus pembrolizumab', 'Lenvatinib plus everolimus', 'lenvatinib plus everolimus and lenvatinib plus pembrolizumab']","['antitumor activity', 'objective response rate, overall survival, safety, health-related quality of life and pharmacokinetics', 'progression-free survival']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2931852', 'cui_str': 'Clear-cell metastatic renal cell carcinoma'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C2986924', 'cui_str': 'lenvatinib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0564859,"Lenvatinib plus pembrolizumab demonstrated promising antitumor activity in a Phase I/II trial of RCC. ","[{'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Grünwald', 'Affiliation': 'Clinic for Hematology, Hemostasis, Oncology and Stem Cell Transplantation, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Experimental Cancer Medicine, Barts Cancer Institute, London, UK.'}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': 'Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Hutson', 'Affiliation': 'Urologic Oncology Program, Baylor University Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Camillo', 'Initials': 'C', 'LastName': 'Porta', 'Affiliation': 'University of Pavia & Division of Translational Oncology, IRCCS Istituti Clinici Scientifici Maugeri, Pavia, Italy.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Eto', 'Affiliation': 'Department of Urology, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'Weill Cornell Medicine, New York-Presbyterian, New York, NY, USA.'}, {'ForeName': 'Sun Young', 'Initials': 'SY', 'LastName': 'Rha', 'Affiliation': 'Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Cixin S', 'Initials': 'CS', 'LastName': 'He', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Corina E', 'Initials': 'CE', 'LastName': 'Dutcus', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Dutta', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Kalgi', 'Initials': 'K', 'LastName': 'Mody', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]","Future oncology (London, England)",['10.2217/fon-2018-0745'] 360,30844990,Upper-Body Resistance Exercise Reduces Time to Recover After a High-Volume Bench Press Protocol in Resistance-Trained Men.,"ABSTRACT Bartolomei, S, Totti, V, Griggio, F, Malerba, C, Ciacci, S, Semprini, G, and Di Michele, R. Upper-body resistance exercise reduces time to recover after a high-volume bench press protocol in resistance-trained men. J Strength Cond Res 35(2S): S180-S187, 2021-The aim of this study was to compare the effects of active and passive strategies on the recovery response after a high-volume bench press protocol. Twenty-five resistance-trained men (mean ± SD: age = 25.8 ± 3.6 years; body mass = 87.1 ± 12.1 kg; and height = 177.4 ± 4.9 cm) performed a high-volume bench press session (8 sets of 10 reps at 70% of 1 repetition maximum). Subsequently, they were randomly assigned to an active recovery (AR) group (n = 11) or to a passive recovery (PR) group (n = 14). Active recovery consisted of light bench press sessions performed 6 hours and 30 hours after the high-volume exercise protocol. Muscle performance (bench throw power [BTP] and isometric bench press [IBP]) and morphology (muscle thickness of pectoralis major [PECMT] and of triceps brachii [TRMT]) were measured before exercise (baseline [BL]), and at 15-minute (15P), 24-hour (24P), and 48-hour (48P) post-exercise. Post-exercise recovery of both maximal strength and power was accelerated in AR compared with PR. Both BTP and IBP were significantly (p < 0.001) reduced at 15P and 24P in PR, whereas changes were significant (p < 0.001) at 15P only in AR. PECMT was still significantly (p = 0.015) altered from BL at 48P in PR, whereas changes were significant (p < 0.001) at 15P only in AR. No significant interactions (p > 0.05) between PR and AR were detected for TRMT and muscle soreness. The present results indicate that AR enhances the recovery rate after high-volume exercise sessions and may be included in resistance training programs to optimize muscle adaptations.",2021,"Both BTP and IBP were significantly (p < 0.001) reduced at 15P and 24P in PR, whereas changes were significant (p < 0.001) at 15P only in AR.","['Resistance-Trained Men', 'Twenty-five resistance-trained men (mean ± SD: age = 25.8 ± 3.6 years; body mass = 87.1 ± 12.1 kg; and height = 177.4 ± 4.9 cm']","['J Strength Cond Res XX(X', 'active recovery (AR) group (n = 11) or to a passive recovery (PR']","['recovery rate', 'Muscle performance (bench throw power [BTP] and isometric bench press [IBP]) and morphology (muscle thickness of pectoralis major [PECMT] and of triceps brachii [TRMT', '15-minute (15P), 24-hour (24P), and 48-hour (48P) post-exercise', 'Bartolomei, S, Totti, V, Griggio, F, Malerba, C, Ciacci, S, Semprini, G, and Di Michele, R. Upper-body resistance exercise reduces time', 'BTP and IBP', 'TRMT and muscle soreness']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0560512', 'cui_str': 'Does throw (finding)'}, {'cui': 'C0454326', 'cui_str': 'Bench press (regime/therapy)'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C1268087', 'cui_str': 'Upper body'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0064368', 'cui_str': ""S-benzyl-O,O'-diisopropylphosphorothiolate""}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}]",,0.0470768,"Both BTP and IBP were significantly (p < 0.001) reduced at 15P and 24P in PR, whereas changes were significant (p < 0.001) at 15P only in AR.","[{'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Bartolomei', 'Affiliation': 'Department of Neuromotor and Biomedical Sciences, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Totti', 'Affiliation': ''}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Griggio', 'Affiliation': ''}, {'ForeName': 'Consuelo', 'Initials': 'C', 'LastName': 'Malerba', 'Affiliation': ''}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Ciacci', 'Affiliation': ''}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Semprini', 'Affiliation': ''}, {'ForeName': 'Rocco', 'Initials': 'R', 'LastName': 'Di Michele', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002960'] 361,30811543,Disseminating Tai Chi in the Community: Promoting Home Practice and Improving Balance.,"BACKGROUND AND OBJECTIVES Falls among older adults is a pressing public health challenge. Considerable research documents that longer tai chi courses can reduce falls and improve balance. However, longer courses can be challenging to implement. Our goal was to evaluate whether a short 6-week modified tai chi course could be effective at reducing falls risk if older adults designed a personal home practice plan to receive a greater tai chi ""dose"" during the 6 weeks. DESIGN A 3-city wait-listed randomized trial was conducted. Habituation Intention and Social Cognitive Theories framed the ""coaching"" strategy by which participants designed practice plans. RE-AIM and Treatment Fidelity Frameworks were used to evaluate implementation and dissemination issues. Three advisory groups advised the study on intervention planning, implementation, and evaluation. To measure effectiveness, we used Centers for Disease Control and Prevention recommended measures for falls risk including leg strength, balance, and mobility and gait. In addition, we measured balance confidence and executive function. RESULTS Program Implementation resulted in large class sizes, strong participant retention, high program fidelity and effectiveness. Participants reported practicing an average of 6 days a week and more than 25 min/day. Leg strength, tandem balance, mobility and gait, balance confidence, and executive function were significantly better for the experimental group than control group. CONCLUSION The tai chi short course resulted in substantial tai chi practice by older adults outside of class as well as better physical and executive function. The course reach, retention, fidelity, and implementation across 3 cities suggest strong potential for implementation and dissemination of the 6-week course.",2020,"Leg strength, tandem balance, mobility and gait, balance confidence, and executive function were significantly better for the experimental group than control group. ",['older adults'],['tai chi'],"['large class sizes, strong participant retention, high program fidelity and effectiveness', 'Leg strength, tandem balance, mobility and gait, balance confidence, and executive function', 'balance confidence and executive function', 'course reach, retention, fidelity, and implementation', 'falls risk including leg strength, balance, and mobility and gait', 'substantial tai chi practice']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0376403', 'cui_str': 'Taiji'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0557314', 'cui_str': 'Number of pupils in class (observable entity)'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}]",,0.0343028,"Leg strength, tandem balance, mobility and gait, balance confidence, and executive function were significantly better for the experimental group than control group. ","[{'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Chewning', 'Affiliation': 'Social and Administrative Sciences Division, School of Pharmacy.'}, {'ForeName': 'Kristine M', 'Initials': 'KM', 'LastName': 'Hallisy', 'Affiliation': 'Doctor of Physical Therapy Program, Department of Family Medicine and Community Health.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Mahoney', 'Affiliation': 'Division of Geriatrics, Department of Medicine, School of Medicine and Public Health.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Wilson', 'Affiliation': 'Social and Administrative Sciences Division, School of Pharmacy.'}, {'ForeName': 'Nisaratana', 'Initials': 'N', 'LastName': 'Sangasubana', 'Affiliation': 'Sonderegger Research Center, School of Pharmacy.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Gangnon', 'Affiliation': 'Population Health, Department of Population Health Sciences.'}]",The Gerontologist,['10.1093/geront/gnz006'] 362,30300051,Females Decrease Vertical Ground Reaction Forces Following 4-Week Jump-Landing Feedback Intervention Without Negative Affect on Vertical Jump Performance.,"CONTEXT High vertical ground reaction force (vGRF) when initiating ground contact during jump landing is one biomechanical factor that may increase risk of anterior cruciate ligament injury. Intervention programs have been developed to decrease vGRF to reduce injury risk, yet generating high forces is still critical for performing dynamic activities such as a vertical jump task. OBJECTIVE To evaluate if a jump-landing feedback intervention, cueing a decrease in vGRF, would impair vertical jump performance in a separate task (Vertmax). DESIGN Randomized controlled trial. Patients (or Other Participants): Forty-eight recreationally active females (feedback: n = 31; 19.63 [1.54] y, 1.6 [0.08] cm, 58.13 [7.84] kg and control: n = 15; 19.6 [1.68] y, 1.64 [0.05] cm, 60.11 [8.36] kg) participated in this study. INTERVENTION Peak vGRF during a jump landing and Vertmax were recorded at baseline and 4 weeks post. The feedback group participated in 12 sessions over the 4-week period consisting of feedback provided for 6 sets of 6 jumps off a 30-cm box. The control group was instructed to return to the lab 28 days following the baseline measurements. MAIN OUTCOME MEASURES Change scores (postbaseline) were calculated for peak vGRF and Vertmax. Group differences were evaluated for peak vGRF and Vertmax using a Mann-Whitney U test (P < .05). RESULTS There were no significant differences between groups at baseline (P > .05). The feedback group (-0.5 [0.3] N/kg) demonstrated a greater decrease in vGRF compared with the control group (0.01 [0.3] N/kg) (t(46) = -5.52, P < .001). There were no significant differences in change in Vertmax between groups (feedback = 0.9 [2.2] cm, control = 0.06 [2.1] cm; t(46) = 0.46, P = .64). CONCLUSIONS While the feedback intervention was effective in decreasing vGRF when landing from a jump, these participants did not demonstrate changes in vertical jump performance when assessed during a different task. Practitioners should consider implementing feedback intervention programs to reduce peak vGRF, without worry of diminished vertical jump performance.",2019,"There were no significant differences in change in Vert max between groups (feedback = 0.9 [2.2] cm, control = 0.06 [2.1] cm; t(46) = 0.46, P = .64). ","['Patients (or Other Participants', 'Forty-eight recreationally active females (feedback: n\u2009=\u200931; 19.63 [1.54]\xa0y, 1.6 [0.08]\xa0cm, 58.13', 'n\u2009=\u200915; 19.6 [1.68]\xa0y, 1.64 [0.05]\xa0cm, 60.11 [8.36]\xa0kg) participated in this study']","['jump-landing feedback intervention', '4-Week Jump-Landing Feedback Intervention', 'control']","['peak vGRF and Vert max ', 'vGRF', 'change in Vert max', 'vertical jump performance', 'Vertical Ground Reaction Forces', 'peak vGRF and Vert max using a Mann-Whitney U test', 'Vertical Jump Performance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C4517508', 'cui_str': '1.6 (qualifier value)'}, {'cui': 'C4517417', 'cui_str': 'Zero point zero eight'}, {'cui': 'C4517509', 'cui_str': '1.64 (qualifier value)'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0242927', 'cui_str': 'Mann-Whitney U Test'}]",,0.0656841,"There were no significant differences in change in Vert max between groups (feedback = 0.9 [2.2] cm, control = 0.06 [2.1] cm; t(46) = 0.46, P = .64). ","[{'ForeName': 'Hayley M', 'Initials': 'HM', 'LastName': 'Ericksen', 'Affiliation': ''}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Lefevre', 'Affiliation': ''}, {'ForeName': 'Brittney A', 'Initials': 'BA', 'LastName': 'Luc-Harkey', 'Affiliation': ''}, {'ForeName': 'Abbey C', 'Initials': 'AC', 'LastName': 'Thomas', 'Affiliation': ''}, {'ForeName': 'Phillip A', 'Initials': 'PA', 'LastName': 'Gribble', 'Affiliation': ''}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Pietrosimone', 'Affiliation': ''}]",Journal of sport rehabilitation,['10.1123/jsr.2018-0140'] 363,30776015,Simultaneous Aerobic Exercise and Memory Training Program in Older Adults with Subjective Memory Impairments.,,2019,,['Older Adults with Subjective Memory Impairments'],['Simultaneous Aerobic Exercise and Memory Training Program'],[],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0233794', 'cui_str': 'Memory Deficits'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0729377', 'cui_str': 'Memory Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",[],,0.0171119,,[],Journal of Alzheimer's disease : JAD,['10.3233/JAD-189014'] 364,30770421,Ultrasound-guided percutaneous peripheral nerve stimulation: neuromodulation of the suprascapular nerve and brachial plexus for postoperative analgesia following ambulatory rotator cuff repair. A proof-of-concept study.,"BACKGROUND AND OBJECTIVES Percutaneous peripheral nerve stimulation (PNS) is an analgesic modality involving the insertion of a lead through an introducing needle followed by the delivery of electric current. This modality has been reported to treat chronic pain as well as postoperative pain following knee and foot surgery. However, it remains unknown if this analgesic technique may be used in ambulatory patients following upper extremity surgery. The purpose of this proof-of-concept study was to investigate various lead implantation locations and evaluate the feasibility of using percutaneous brachial plexus PNS to treat surgical pain following ambulatory rotator cuff repair in the immediate postoperative period. METHODS Preoperatively, an electrical lead (SPR Therapeutics, Cleveland, Ohio) was percutaneously implanted to target the suprascapular nerve or brachial plexus roots or trunks using ultrasound guidance. Postoperatively, subjects received 5 min of either stimulation or sham in a randomized, double-masked fashion followed by a 5 min crossover period, and then continuous stimulation until lead removal postoperative days 14-28. RESULTS Leads (n=2) implanted at the suprascapular notch did not appear to provide analgesia, and subsequent leads (n=14) were inserted through the middle scalene muscle and placed to target the brachial plexus. Three subjects withdrew prior to data collection. Within the recovery room, stimulation did not decrease pain scores during the first 40 min of the remaining subjects with brachial plexus leads, regardless of which treatment subjects were randomized to initially. Seven of these 11 subjects required a single-injection interscalene nerve block for rescue analgesia prior to discharge. However, subsequent average resting and dynamic pain scores postoperative days 1-14 had a median of 1 or less on the Numeric Rating Scale, and opioid requirements averaged less than 1 tablet daily with active stimulation. Two leads dislodged during use and four fractured on withdrawal, but no infections, nerve injuries, or adverse sequelae were reported. CONCLUSIONS This proof-of-concept study demonstrates that ultrasound-guided percutaneous PNS of the brachial plexus is feasible for ambulatory shoulder surgery, and although analgesia immediately following surgery does not appear to be as potent as local anesthetic-based peripheral nerve blocks, the study suggests that this modality may provide analgesia and decrease opioid requirements in the days following rotator cuff repair. Therefore, it suggests that a subsequent, large, randomized clinical trial with an adequate control group is warranted to further investigate this therapy in the management of surgical pain in the immediate postoperative period. However, multiple technical issues remain to be resolved, such as the optimal lead location, insertion technique, and stimulating protocol, as well as preventing lead dislodgment and fracture. TRIAL REGISTRATION NUMBER NCT02898103.",2019,"Within the recovery room, stimulation did not decrease pain scores during the first 40 min of the remaining subjects with brachial plexus leads, regardless of which treatment subjects were randomized to initially.","['ambulatory rotator cuff repair', 'ambulatory patients following upper extremity surgery']","['percutaneous brachial plexus PNS', 'Ultrasound-guided percutaneous peripheral nerve stimulation', 'Percutaneous peripheral nerve stimulation (PNS']","['Numeric Rating Scale, and opioid requirements', 'no infections, nerve injuries, or adverse sequelae', 'pain scores']","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0006090', 'cui_str': 'Brachial Plexus'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0031119', 'cui_str': 'Peripheral Nerves'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0222045'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0161479', 'cui_str': 'Nerve injury (disorder)'}, {'cui': 'C0243088', 'cui_str': 'sequelae'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",14.0,0.107988,"Within the recovery room, stimulation did not decrease pain scores during the first 40 min of the remaining subjects with brachial plexus leads, regardless of which treatment subjects were randomized to initially.","[{'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Ilfeld', 'Affiliation': 'Department of Anesthesiology, University of California San Diego, San Diego, California, USA bilfeld@ucsd.edu.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Finneran', 'Affiliation': 'Department of Anesthesiology, University of California San Diego, San Diego, California, USA.'}, {'ForeName': 'Rodney A', 'Initials': 'RA', 'LastName': 'Gabriel', 'Affiliation': 'Department of Anesthesiology, University of California San Diego, San Diego, California, USA.'}, {'ForeName': 'Engy T', 'Initials': 'ET', 'LastName': 'Said', 'Affiliation': 'Department of Anesthesiology, University of California San Diego, San Diego, California, USA.'}, {'ForeName': 'Patrick L', 'Initials': 'PL', 'LastName': 'Nguyen', 'Affiliation': 'Department of Anesthesiology, University of California San Diego, San Diego, California, USA.'}, {'ForeName': 'Wendy B', 'Initials': 'WB', 'LastName': 'Abramson', 'Affiliation': 'Department of Anesthesiology, University of California San Diego, San Diego, California, USA.'}, {'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Khatibi', 'Affiliation': 'Department of Anesthesiology, University of California San Diego, San Diego, California, USA.'}, {'ForeName': 'Jacklynn F', 'Initials': 'JF', 'LastName': 'Sztain', 'Affiliation': 'Department of Anesthesiology, University of California San Diego, San Diego, California, USA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Swisher', 'Affiliation': 'Department of Anesthesiology, University of California San Diego, San Diego, California, USA.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Jaeger', 'Affiliation': 'Department of Anesthesiology, University of California San Diego, San Diego, California, USA.'}, {'ForeName': 'Dana C', 'Initials': 'DC', 'LastName': 'Covey', 'Affiliation': 'Departments of Orthopaedic Surgery, University of California San Diego, San Diego, California, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Meunier', 'Affiliation': 'Departments of Orthopaedic Surgery, University of California San Diego, San Diego, California, USA.'}, {'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Hentzen', 'Affiliation': 'Departments of Orthopaedic Surgery, University of California San Diego, San Diego, California, USA.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Robertson', 'Affiliation': 'Departments of Orthopaedic Surgery, University of California San Diego, San Diego, California, USA.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2018-100121'] 365,30222489,Comparing the Effects of SUREE Programs on People With Scapular Downward Rotation Syndrome: A Randomized Clinical Trial.,"CONTEXT Scapular downward rotation syndrome (SDRS) is an impaired alignment that causes shoulder and neck pain. Interventions may lead to the reduction of pain intensity and joint position error (JPE) and improved range of motion (ROM). OBJECTIVE To evaluate the effects of 6-week Scapular Upward Rotation and Elevation Exercises (SUREE) with and without visual feedback on pain, ROM, and JPE in people with SDRS. STUDY DESIGN Randomized control trial. SETTING Institutional practice. PARTICIPANTS Forty-two young and active subjects (22.61 [1.80] y; 27 males and 15 females) with unilateral SDRS randomly assigned into 3 groups (2 intervention groups and 1 control group). INTERVENTIONS SUREE without and with visual feedback programs. MAIN OUTCOME MEASURES Pain, neck-flexion and rotation ROMs, and JPE were measured using visual analog scale (score), double inclinometer method, universal goniometer method (degrees), and a dual digital inclinometer (degrees), respectively, before and after interventions. RESULTS The results showed statistically significant changes within the experimental groups in all variables except for the neck rotation ROM in the SUREE intervention without visual feedback (P < .05). However, there were no changes in the control group before and after the interventions in all dependent variables (P < .05). Also, there were no significant differences between both experimental groups concerning all dependent variables except for the rotation ROM (P < .05). CONCLUSION The results suggest that the 6-week SUREE with and without visual feedback programs result in decreased neck pain and improved flexion ROM and JPE during active neck motions in subjects with unilateral SDRS. However, the 6-week SUREE with visual feedback may improve the neck rotation ROM in subjects with unilateral SDRS. However, further studies are needed to confirm the results of this study.",2019,The results showed statistically significant changes within the experimental groups in all variables except for the neck rotation ROM in the SUREE intervention without visual feedback (P < .05).,"['subjects with unilateral SDRS', 'y; 27 males and 15 females) with unilateral SDRS', 'People With Scapular Downward Rotation Syndrome', 'Forty-two young and active subjects (22.61 [1.80', 'people with SDRS']","['6-week Scapular Upward Rotation and Elevation Exercises (SUREE) with and without visual feedback', 'SUREE Programs', 'SUREE without and with visual feedback programs']","['Pain, neck-flexion and rotation ROMs, and JPE were measured using visual analog scale (score), double inclinometer method, universal goniometer method (degrees), and a dual digital inclinometer (degrees', 'pain intensity and joint position error (JPE) and improved range of motion (ROM', 'neck rotation ROM', 'neck pain and improved flexion ROM and JPE', 'visual feedback', 'rotation ROM', 'pain, ROM, and JPE']","[{'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205104', 'cui_str': 'Down (qualifier value)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1282911', 'cui_str': 'Upward (qualifier value)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0445088', 'cui_str': 'Neck flexion (finding)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C4518350', 'cui_str': 'Neck rotation'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}]",42.0,0.0675326,The results showed statistically significant changes within the experimental groups in all variables except for the neck rotation ROM in the SUREE intervention without visual feedback (P < .05).,"[{'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Derakhshani', 'Affiliation': ''}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Letafatkar', 'Affiliation': ''}, {'ForeName': 'Zohre', 'Initials': 'Z', 'LastName': 'Khosrokiani', 'Affiliation': ''}]",Journal of sport rehabilitation,['10.1123/jsr.2018-0051'] 366,32408390,Does tamsulosin or mirabegron improve ureteral stent-related symptoms? A prospective placebo-controlled study.,"OBJECTIVE The main objective of this study was to evaluate the efficacy of tamsulosin or mirabegron on ureteral stent-related symptoms. PATIENTS AND METHODS This was a prospective, randomized, controlled, and single-blinded study. In total, 180 patients who had undergone ureterolithotripsy and ureteral stent insertion were included. Patients were randomly divided into three groups as follows: Group 1 was the control group taking placebo; group 2 was administered tamsulosin (0.4 mg) once a day; and group 3 received mirabegron (50 mg) once a day. The Turkish version of the ureteral stent symptom questionnaire was filled out after 4 weeks. RESULTS After excluding patients who were lost to follow-up, 161 patients were included in the final analysis. Analgesic usage doses were lower in the tamsulosin (5.1 ± 1.8) and mirabegron (4.5 ± 1.4) groups than in the control group (5.9 ± 2.1; P < .001). The urinary symptoms score was lower in tamsulosin group than it was in the control group (22.1 vs 27.8; P = .001); however, the other scores (body pain, general health, work performance, sexual matters, and other problems) were similar between the groups. CONCLUSIONS Tamsulosin improves only urinary symptoms due to the ureteral stent and decreases the need for analgesics. Mirabegron has no effect on ureteral stent-related symptoms, but it decreases analgesic need.",2021,Analgesic usage doses were lower in the tamsulosin (5.1 ± 1.8) and mirabegron (4.5 ± 1.4) groups than in the control group (5.9 ± 2.1; P < .001).,"['After excluding patients who were lost to follow-up, 161 patients were included in the final analysis', '180 patients who had undergone ureterolithotripsy and ureteral stent insertion were included']","['tamsulosin', 'Tamsulosin', 'mirabegron', 'placebo']","['urinary symptoms score', 'Analgesic usage doses', 'scores (body pain, general health, work performance, sexual matters, and other problems', 'Turkish version of the ureteral stent symptom questionnaire']","[{'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0864052', 'cui_str': 'Ureteral stent insertion'}]","[{'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C1286385', 'cui_str': 'Performance at work'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0041402', 'cui_str': 'Turkish language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0183518', 'cui_str': 'Ureteric stent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",180.0,0.0625317,Analgesic usage doses were lower in the tamsulosin (5.1 ± 1.8) and mirabegron (4.5 ± 1.4) groups than in the control group (5.9 ± 2.1; P < .001).,"[{'ForeName': 'Abdulmecit', 'Initials': 'A', 'LastName': 'Yavuz', 'Affiliation': 'Urology Department, Gelisim Private Hospital, Hatay, Turkey.'}, {'ForeName': 'Muhammet F', 'Initials': 'MF', 'LastName': 'Kilinc', 'Affiliation': 'Urology Department, Ankara Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Aydin', 'Affiliation': 'Urology Department, Samsun Training and Research Hospital, Samsun, Turkey.'}, {'ForeName': 'Yilmaz', 'Initials': 'Y', 'LastName': 'Ofluoglu', 'Affiliation': 'Urology Department, Medical Park Private Hospital, Trabzon, Turkey.'}, {'ForeName': 'Göksel', 'Initials': 'G', 'LastName': 'Bayar', 'Affiliation': 'Urology Department, Sancaktepe Martyr Prof Dr Ilhan Varank Training and Research Hospital, Istanbul, Turkey.'}]",Lower urinary tract symptoms,['10.1111/luts.12320'] 367,30482661,Comparative Effectiveness of Bladder-preserving Tri-modality Therapy Versus Radical Cystectomy for Muscle-invasive Bladder Cancer.,"INTRODUCTION There are limited randomized data comparing radical cystectomy (RC) with bladder-sparing tri-modality therapy (TMT) in the treatment of muscle-invasive bladder cancer (MIBC). Both strategies are thought to have similar survival outcomes with different morbidity profiles. We compare the effectiveness of TMT and RC using decision-analytic modeling and the endpoint of quality-adjusted life years (QALYs). PATIENTS AND METHODS Using a Markov model, we simulated the lifetime outcomes after TMT versus RC ± neoadjuvant chemotherapy for 67-year-old patients with clinical stage T2-T4aN0M0 MIBC. Model probabilities and utilities were extracted from the literature. The incremental effectiveness was reported in QALYs and sensitivity analyses were performed. RESULTS For all patients with MIBC, although the model showed identical survival, TMT was the most effective strategy with an incremental gain of 0.59 QALYs over RC (7.83 vs. 7.24 QALYs, respectively). When limiting the model to favorable, contemporary cohorts in both the TMT and RC strategies, TMT remained more effective with an incremental gain of 1.61 QALYs (9.37 vs. 7.76 QALYs, respectively). One-way sensitivity analyses demonstrated the model was sensitive to the quality of life parameters (ie, the utilities) for RC and TMT. When testing the 95% confidence interval of the RC utility parameter the model demonstrated an incremental gain with TMT from -0.54 to 4.23 QALYs. Probabilistic sensitivity analysis demonstrated that TMT was more effective than RC for 63% of model iterations. CONCLUSIONS This modeling study found that treatment of MIBC with organ-sparing TMT in appropriately-selected patients may result in a gain of QALYs relative to RC.",2019,"Probabilistic sensitivity analysis demonstrated that TMT was more effective than RC for 63% of model iterations. ","['Muscle-invasive Bladder Cancer', 'muscle-invasive bladder cancer (MIBC', '67-year-old patients with clinical stage T2-T4aN0M0 MIBC']","['TMT versus RC ± neoadjuvant chemotherapy', 'TMT', 'Bladder-preserving Tri-modality Therapy Versus Radical Cystectomy', 'MIBC with organ-sparing TMT', 'radical cystectomy (RC) with bladder-sparing tri-modality therapy (TMT']","['quality of life parameters', 'quality-adjusted life years (QALYs']","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205563', 'cui_str': 'Clinical staging (qualifier value)'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0065404', 'cui_str': 'Tri (L)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0194401', 'cui_str': 'Total resection of urinary bladder (procedure)'}]","[{'cui': 'C0034380'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0080071', 'cui_str': 'QALY'}]",,0.0536551,"Probabilistic sensitivity analysis demonstrated that TMT was more effective than RC for 63% of model iterations. ","[{'ForeName': 'Trevor J', 'Initials': 'TJ', 'LastName': 'Royce', 'Affiliation': 'Department of Radiation Oncology, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Adam S', 'Initials': 'AS', 'LastName': 'Feldman', 'Affiliation': 'Department of Urology, Massachusetts General Hospital, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Mossanen', 'Affiliation': 'Department of Urology, Massachusetts General Hospital, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Joanna C', 'Initials': 'JC', 'LastName': 'Yang', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'William U', 'Initials': 'WU', 'LastName': 'Shipley', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Pari V', 'Initials': 'PV', 'LastName': 'Pandharipande', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA; Institute for Technology Assessment, Massachusetts General Hospital, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Efstathiou', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA. Electronic address: jefstathiou@partners.org.'}]",Clinical genitourinary cancer,['10.1016/j.clgc.2018.09.023'] 368,31688612,Reducing Postoperative Call Volume Through Verbal Preoperative Education.,"OBJECTIVE To improve patient satisfaction and understanding of what to expect after chronic ear surgery and reduce call volume to an otology clinic at an academic tertiary referral center. STUDY DESIGN Quality improvement initiative. SETTING A single-academic tertiary referral center. PATIENTS One hundred and ten patients who underwent chronic ear surgery in March to May 2018. INTERVENTION Preoperative counseling over the phone 1 week before surgery. MAIN OUTCOME MEASURES Patient call volume to the clinic within a 2-week postoperative window, patient understanding, and satisfaction of perioperative course. RESULTS There was a significant increase in patient satisfaction (10.1% increase, 9.8 intervention vs. 8.9 no intervention, p = 0.0032) and in patient understanding of what to expect after surgery (6.7% increase, 9.5 intervention vs. 8.9 no intervention, p = 0.0275). There was a significant decrease in mean number of calls per patient to the clinic (57.6% decrease, 0.31 intervention vs. 0.72 no intervention, p = 0.0105) and in percentage of patients who made any number of calls to the clinic (20% intervention vs. 46%, no intervention, p = 0.00438). CONCLUSIONS Verbal preoperative counseling over the phone was effective in significantly reducing unnecessary call volume to the clinic and in improving patient satisfaction and overall understanding of what to expect after surgery.",2020,"There was a significant increase in patient satisfaction (10.1% increase, 9.8 intervention vs. 8.9 no intervention, p = 0.0032) and in patient understanding of what to expect after surgery (6.7% increase, 9.5 intervention vs. 8.9 no intervention, p = 0.0275).","['A single-academic tertiary referral center', 'One hundred and ten patients who underwent chronic ear surgery in March to May 2018']",['Verbal preoperative counseling'],"['patient satisfaction', 'mean number of calls per patient to the clinic']","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0013443', 'cui_str': 'Vestibulocochlear Apparatus'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0920638', 'cui_str': 'Preoperative counseling (procedure)'}]","[{'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]",110.0,0.0174545,"There was a significant increase in patient satisfaction (10.1% increase, 9.8 intervention vs. 8.9 no intervention, p = 0.0032) and in patient understanding of what to expect after surgery (6.7% increase, 9.5 intervention vs. 8.9 no intervention, p = 0.0275).","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Chern', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Columbia University Irving Medical Center.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Haynes', 'Affiliation': 'The Otology Group of Vanderbilt University, Department of Otolaryngology-Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Marc L', 'Initials': 'ML', 'LastName': 'Bennett', 'Affiliation': 'The Otology Group of Vanderbilt University, Department of Otolaryngology-Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, Tennessee.'}]","Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology",['10.1097/MAO.0000000000002470'] 369,30674695,Face and construct validity of TU-Delft epidural simulator and the value of real-time visualization.,"BACKGROUND AND OBJECTIVES Learning epidural anesthesia traditionally involves bedside teaching. Visualization aids or a simulator can help in acquiring motor skills, increasing patient safety and steepening the learning curve. We evaluated the face and construct validity of the TU-Delft Epidural Simulator and the effect of needle visualization. METHODS Sixty-eight anesthesiologists, anesthesia residents, and final-year medical students tested the epidural simulator. Participants performed six epidural simulations with and six without needle visualization. We tested face validity on a Likert scale questionnaire. We collected data with the simulator software (spinal taps, dura contacts, bone contacts, attempts, and time) and tested for correlation with the performer's experience (construct validity). A visualization aid was tested in a randomized crossover design. RESULTS Face validity as rated by the participants was above average, with a mean of 3.7 (2.0-4.8) on a 5-point scale. Construct validity was indicated by significantly more spinal taps (0.4 [0-4) vs 0.07 [0-2], p=0.04) and more dura contacts (0.58 [0-6] vs 0.37 [0-3], p=0.002) by the inexperienced group compared with the expert group. The visualization aid improved performance by reducing the number of bone contacts and the number of attempts, and by decreasing the procedure time. Prior visualization training reduced the total procedure time from 279 s (69-574) to 180 s (53-605) (p = 0.01) for the ""blind"" procedure. CONCLUSIONS The TU-Delft Epidural Simulator is a useful tool for teaching motor skills during epidural needle placement. Prior use of a visualization tool improves performance even without visual support during consequent simulations.",2019,"The visualization aid improved performance by reducing the number of bone contacts and the number of attempts, and by decreasing the procedure time.","['Sixty-eight anesthesiologists, anesthesia residents, and final-year medical students tested the epidural simulator']","['epidural simulations with and six without needle visualization', 'Prior visualization training']","['Construct validity', 'dura contacts', 'Likert scale questionnaire', 'number of bone contacts', 'total procedure time']","[{'cui': 'C0450387', 'cui_str': '68 (qualifier value)'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}]","[{'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",6.0,0.0341058,"The visualization aid improved performance by reducing the number of bone contacts and the number of attempts, and by decreasing the procedure time.","[{'ForeName': 'Nenad', 'Initials': 'N', 'LastName': 'Zivkovic', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Ganapathy', 'Initials': 'G', 'LastName': 'van Samkar', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Hermanns', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands h.hermanns@amc.nl.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Lirk', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Hollmann', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'van den Dobbelsteen', 'Affiliation': 'Technical Department of BioMechanical Engineering, Technical University of Delft, Delft, The Netherlands.'}, {'ForeName': 'Dennis J', 'Initials': 'DJ', 'LastName': 'van Gerwen', 'Affiliation': 'Technical Department of BioMechanical Engineering, Technical University of Delft, Delft, The Netherlands.'}, {'ForeName': 'Markus F', 'Initials': 'MF', 'LastName': 'Stevens', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2018-100161'] 370,30674696,"Effects of programmed intermittent thoracic paravertebral bolus of levobupivacaine on the spread of sensory block: a randomized, controlled, double-blind study.","BACKGROUND AND OBJECTIVES This randomized, controlled, double-blind trial compared the effectiveness of levobupivacaine delivery of a programmed intermittent paravertebral bolus with a continuous paravertebral infusion. METHODS Thirty-two consecutively enrolled patients who underwent unilateral video-assisted thoracic surgery were randomized to receive either a programmed intermittent paravertebral bolus of 10 mL of 0.2% levobupivacaine every 2 hours (Bolus group, n=16) or a continuous paravertebral infusion of 0.2% levobupivacaine at 5 mL/hour (Infusion group, n=16) after the operation. Postoperatively, after injection of 20 mL of 0.25% levobupivacaine through the paravertebral catheter, a mechanical infusion pump was set depending on the assigned group. The primary efficacy outcome was the number of anesthetized dermatomes 24 hours after the initial bolus of levobupivacaine. The secondary efficacy outcomes included the number of anesthetized dermatomes at other time points, pain at rest and coughing, additional analgesic use and patient acceptance of the analgesic technique. Arterial levobupivacaine concentration was measured to ensure safety. P<0.05 was considered statistically significant. RESULTS The mean (95% CI) number of anesthetized dermatomes 24 hours after the initial bolus of levobupivacaine was significantly larger among subjects receiving programmed intermittent bolus (n=16) compared with those receiving continuous infusion (n=16; 6.8 (5.7-7.9) vs 3.1 (2.0-4.2); p<0.001). The arterial levobupivacaine concentration did not reach a toxic level. CONCLUSIONS The programmed intermittent paravertebral bolus of levobupivacaine provided a wider dermatomal spread of sensory block than continuous paravertebral infusion with an identical hourly dose of levobupivacaine. TRIAL REGISTRATION NUMBER UMIN000022532.",2019,"The programmed intermittent paravertebral bolus of levobupivacaine provided a wider dermatomal spread of sensory block than continuous paravertebral infusion with an identical hourly dose of levobupivacaine. ",['Thirty-two consecutively enrolled patients who underwent unilateral video-assisted thoracic surgery'],"['levobupivacaine', 'programmed intermittent paravertebral bolus of 10\u2009mL of 0.2% levobupivacaine', 'continuous paravertebral infusion of 0.2% levobupivacaine']","['Arterial levobupivacaine concentration', 'spread of sensory block', 'number of anesthetized dermatomes at other time points, pain at rest and coughing, additional analgesic use and patient acceptance of the analgesic technique', 'arterial levobupivacaine concentration', 'number of anesthetized dermatomes 24\u2009hours']","[{'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0752151', 'cui_str': 'VATS'}]","[{'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0332261', 'cui_str': 'Spread (attribute)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1720436', 'cui_str': 'Anesthetized'}, {'cui': 'C0392338', 'cui_str': 'Dermatome (body structure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0234253', 'cui_str': 'Rest pain (finding)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0412784', 'cui_str': 'Analgesic technique (procedure)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}]",32.0,0.404802,"The programmed intermittent paravertebral bolus of levobupivacaine provided a wider dermatomal spread of sensory block than continuous paravertebral infusion with an identical hourly dose of levobupivacaine. ","[{'ForeName': 'Kumiko', 'Initials': 'K', 'LastName': 'Hida', 'Affiliation': 'Department of Anesthesiology, Nagasaki University School of Medicine, Nagasaki, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Murata', 'Affiliation': 'Department of Anesthesiology, Nagasaki University School of Medicine, Nagasaki, Japan hiroakimurata122@gmail.com.'}, {'ForeName': 'Taiga', 'Initials': 'T', 'LastName': 'Ichinomiya', 'Affiliation': 'Department of Anesthesiology, Nagasaki University School of Medicine, Nagasaki, Japan.'}, {'ForeName': 'Haruka', 'Initials': 'H', 'LastName': 'Inoue', 'Affiliation': 'Department of Anesthesiology, Nagasaki University School of Medicine, Nagasaki, Japan.'}, {'ForeName': 'Shuntaro', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Clinical Research Center, Nagasaki University Hospital, Nagasaki, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Hara', 'Affiliation': 'Department of Anesthesiology, Nagasaki University School of Medicine, Nagasaki, Japan.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2018-100021'] 371,31694576,"Induction techniques that reduce redistribution hypothermia: a prospective, randomized, controlled, single blind effectiveness study.","BACKGROUND While much effort has been devoted to correcting intraoperative hypothermia, less attention has been directed to preventing redistribution hypothermia. In this study, we compared three different anesthetic induction techniques to standard IV propofol inductions (control) in their effect on reducing redistribution hypothermia. METHODS Elective, afebrile patients, age 18 to 55 years, were randomly assigned to one of four groups (n = 50 each). Group ""INH/100"" was induced with 8% sevoflurane in 100% oxygen, Group ""INH/50"" with 8% sevoflurane in 50% oxygen and 50% nitrous oxide, Group ""PROP"" with 2.2 mg/kg propofol, and Group ""Phnl/PROP"" with 2.2 mg/kg propofol immediately preceded by 160 mcg phenylephrine. Patients were maintained with sevoflurane in 50% nitrous oxide and 50% oxygen in addition to opioid narcotic. Forced air warming was used. Core temperatures were recorded every 15 min after induction for 1 h. RESULTS Compared to control group PROP, the mean temperatures in groups INH/100, INH/50, and Phnl/PROP were higher 15, 30, 45 and 60 min after induction (p < 0.001 for all comparisons), averaging between 0.39 °C and 0.54 °C higher. In group PROP, 60% of patients had at least one temperature below 36.0 °C in the first hour whereas only 16% did in each of groups INH/100, INH/50, and Phnl/PROP (p < 0.0001 in each group compared to PROP). CONCLUSIONS In this effectiveness trial, inhalation inductions with sevoflurane or with prophylactic phenylephrine bolus prior to propofol induction reduced the magnitude of redistribution hypothermia by an average of 0.4 to 0.5 °C in patients aged 18 to 55 years. TRIAL REGISTRATION Retrospectively registered on clinical-trials.gov as NCT02331108 , November 20, 2014.",2019,"Core temperatures were recorded every 15 min after induction for 1 h. RESULTS Compared to control group PROP, the mean temperatures in groups INH/100, INH/50, and Phnl/PROP were higher 15, 30, 45 and 60 min after induction (p < 0.001 for all comparisons), averaging between 0.39 °C and 0.54 °C higher.","['Elective, afebrile patients, age 18 to 55\u2009years', 'patients aged 18 to 55\u2009years']","['nitrous oxide and 50% oxygen in addition to opioid narcotic', 'phenylephrine', 'prophylactic phenylephrine', 'sevoflurane', 'standard IV propofol inductions (control', 'sevoflurane in 50% oxygen and 50% nitrous oxide, Group ""PROP"" with 2.2\u2009mg/kg propofol, and Group ""Phnl/PROP"" with 2.2\u2009mg/kg propofol']","['redistribution hypothermia', 'Core temperatures']","[{'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0277797', 'cui_str': 'Apyrexial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C0332620', 'cui_str': 'Redistribution (finding)'}, {'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}]",,0.0624361,"Core temperatures were recorded every 15 min after induction for 1 h. RESULTS Compared to control group PROP, the mean temperatures in groups INH/100, INH/50, and Phnl/PROP were higher 15, 30, 45 and 60 min after induction (p < 0.001 for all comparisons), averaging between 0.39 °C and 0.54 °C higher.","[{'ForeName': 'Jonathan V', 'Initials': 'JV', 'LastName': 'Roth', 'Affiliation': 'Department of Anesthesiology, Albert Einstein Medical Center, 5501 Old York Road, Philadelphia, PA, USA. jvroth1@aol.com.'}, {'ForeName': 'Leonard E', 'Initials': 'LE', 'LastName': 'Braitman', 'Affiliation': 'Office for Research and Technology Development, Albert Einstein Medical Center, 5501 Old York Road, Philadelphia, PA, USA.'}, {'ForeName': 'Lacy H', 'Initials': 'LH', 'LastName': 'Hunt', 'Affiliation': 'Office for Research and Technology Development, Albert Einstein Medical Center, 5501 Old York Road, Philadelphia, PA, USA.'}]",BMC anesthesiology,['10.1186/s12871-019-0866-8'] 372,30679332,Systemic dexmedetomidine is not as efficient as perineural dexmedetomidine in prolonging an ulnar nerve block.,"BACKGROUND We tested the joint hypotheses that both perineural and systemic dexmedetomidine prolong the duration of an ulnar nerve block (UNB) compared with ropivacaine alone and that systemic dexmedetomidine is noninferior compared with perineural dexmedetomidine in block prolongation. METHODS We performed bilateral UNBs in 22 healthy volunteers on two separate days. On the first day, each arm was randomized to either 4 mL ropivacaine 5 mg/mL+1 mL dexmedetomidine 100 µg/mL (Perineural) or 4 mL ropivacaine 5 mg/mL+1 mL saline (Systemic). On the subsequent treatment day, each arm was randomized to 1 mL of saline plus 4 mL of ropivacaine at either 7.5 mg/mL(HiRopi) or 5 mg/mL (NoDex). The primary outcome measure was the duration of sensory block assessed by mechanical discrimination. RESULTS Mean sensory block duration was longer in both the Perineural (14.4 hours, 95% CI 13.1 to 15.6) and Systemic treatments (9.2 hours, 95% CI 8.6 to 9.8) compared with the NoDex treatment (7.1 hours, 95% CI 6.6 to 7.6) (p<0.0001 for both). Systemic dexmedetomidine was inferior (not noninferior) compared with perineural dexmedetomidine, as the 95% CI of the difference (mean difference 5.2 hour, 95% CI 4.2 to 6.1) exceeded the noninferiority limit of 3.6 hour. Onset time did not differ among the groups. The other test modalities demonstrated similar block durations as the primary outcome. CONCLUSIONS Adding dexmedetomidine perineurally to ropivacaine doubles the duration of an UNB. Systemic dexmedetomidine also prolongs the duration of UNB, but has less of an effect compared with the perineural route. TRIAL REGISTRATION NUMBER NCT03222323.",2019,"Mean sensory block duration was longer in both the Perineural (14.4 hours, 95% CI 13.1 to 15.6) and Systemic treatments (9.2 hours, 95% CI 8.6 to 9.8) compared with the NoDex treatment (7.1 hours, 95% CI 6.6 to 7.6) (p<0.0001 for both).",['22 healthy volunteers on two separate days'],"['Systemic dexmedetomidine', 'ropivacaine', 'mL ropivacaine', 'mL+1\u2009mL saline', 'dexmedetomidine', 'ropivacaine 5\u2009mg/mL+1', 'saline plus 4\u2009mL of ropivacaine at either 7.5\u2009mg/mL(HiRopi) or 5\u2009mg/mL (NoDex', 'mL dexmedetomidine 100\u2009µg/mL (Perineural) or 4']","['duration of sensory block assessed by mechanical discrimination', 'duration of UNB', 'Mean sensory block duration', 'duration of an UNB', 'duration of an ulnar nerve block (UNB']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0394707', 'cui_str': 'Local anesthetic ulnar nerve block (procedure)'}]",22.0,0.418208,"Mean sensory block duration was longer in both the Perineural (14.4 hours, 95% CI 13.1 to 15.6) and Systemic treatments (9.2 hours, 95% CI 8.6 to 9.8) compared with the NoDex treatment (7.1 hours, 95% CI 6.6 to 7.6) (p<0.0001 for both).","[{'ForeName': 'Jakob Hessel', 'Initials': 'JH', 'LastName': 'Andersen', 'Affiliation': 'Department of Anesthesiology, Zealand University Hospital, Koege, Denmark hessel@dadlnet.dk.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Jaeger', 'Affiliation': 'Department of Anesthesiology, Rigshospitalet, Kobenhavn, Denmark.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Grevstad', 'Affiliation': 'Department of Anesthesiology, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Stine', 'Initials': 'S', 'LastName': 'Estrup', 'Affiliation': 'Department of Anesthesiology, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Geisler', 'Affiliation': 'Department of Anesthesiology, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Vilhelmsen', 'Affiliation': 'Department of Anesthesiology, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'Jorgen B', 'Initials': 'JB', 'LastName': 'Dahl', 'Affiliation': 'Department of Anesthesiology, Bispebjerg Hospital, Kobenhavn, Denmark.'}, {'ForeName': 'Gunnar Hellmund', 'Initials': 'GH', 'LastName': 'Laier', 'Affiliation': 'Production Research and Innovation, Region Zealand, Soroe, Denmark.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Ilfeld', 'Affiliation': 'Division of Regional Anesthesia and Acute Pain Medicine, Department of Anesthesiology, University of California, San Diego, La Jolla, USA.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Mathiesen', 'Affiliation': 'Department of Anesthesiology, Zealand University Hospital, Koege, Denmark.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2018-100089'] 373,30679333,Randomized controlled trial of a simplified adductor canal block performed for analgesia following total knee arthroplasty.,"BACKGROUND AND OBJECTIVES The objective of the study was to determine if injection of local anesthetic into the vastus medialis and sartorius muscles adjacent to the adductor canal produces sensory changes comparable with adductor canal block (ACB). This could result in a technically easier and potentially safer alternative to ACB. METHODS In this randomized controlled trial, patients received either ACB (n=20) or a simplified adductor canal (SAC) block performed using a new fenestrated nerve block needle (n=20). The time to perform each block as well as the number of attempts to position the needle were evaluated. A non-inferiority test was used to compare pain scores and opioid requirements for the ACB and the SAC block. RESULTS The SAC block was performed more rapidly, with fewer needle passes, and had a higher success rate than the ACB. Three block failures and two vessel punctures were observed in the ACB group, while none of these events occurred in SAC block patients. Analgesia and opioid consumption for patients treated with the SAC block were not inferior to ACB. CONCLUSION The SAC block is technically easier to perform and potentially safer than ACB. This procedure can be performed using easily visible ultrasound landmarks and has the potential for use among a wide range of healthcare providers. TRIAL REGISTRATION NUMBER NCT02786888.",2019,"The SAC block was performed more rapidly, with fewer needle passes, and had a higher success rate than the ACB.","['total knee arthroplasty', 'patients treated with the SAC block']","['simplified adductor canal (SAC) block performed using a new fenestrated nerve block needle', 'simplified adductor canal block', 'ACB', 'adductor canal block (ACB']","['Analgesia and opioid consumption', 'pain scores and opioid requirements']","[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0027741', 'cui_str': 'Nerve Blockade'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}]","[{'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",,0.121147,"The SAC block was performed more rapidly, with fewer needle passes, and had a higher success rate than the ACB.","[{'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Swenson', 'Affiliation': 'Department of Anesthesiology, University of Utah Health Sciences Center, Salt Lake City, Utah, USA.'}, {'ForeName': 'Jacob E', 'Initials': 'JE', 'LastName': 'Pollard', 'Affiliation': 'Department of Anesthesiology, University of Utah Health Sciences Center, Salt Lake City, Utah, USA.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Peters', 'Affiliation': 'Department of Orthopaedics, Adult Reconstruction Division, University of Utah Health Sciences Center, Salt Lake City, Utah, USA chris.peters@hsc.utah.edu.'}, {'ForeName': 'Mike B', 'Initials': 'MB', 'LastName': 'Anderson', 'Affiliation': 'Department of Orthopaedics, Adult Reconstruction Division, University of Utah Health Sciences Center, Salt Lake City, Utah, USA.'}, {'ForeName': 'Nathan L', 'Initials': 'NL', 'LastName': 'Pace', 'Affiliation': 'Department of Anesthesiology, University of Utah Health Sciences Center, Salt Lake City, Utah, USA.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2018-100070'] 374,31679018,"Effects of sleep on a high-heat capacity mattress on sleep stages, EEG power spectra, cardiac interbeat intervals and body temperatures in healthy middle-aged men‡.","STUDY OBJECTIVES This study deals with the question whether a slow (non-disturbing) reduction of core body temperature (CBT) during sleep increases sleep stage N3 and EEG slow wave energy (SWE) and leads to a slowing of heart rate in humans. PARTICIPANTS Thirty-two healthy male subjects with a mean ± SD age 46 ± 4 years and body mass index 25.2 ± 1.8 kg/m2. METHODS A high-heat capacity mattress (HM) was used to lower body temperatures in sleep and was compared to a conventional low-heat capacity mattress (LM) in a double-blinded fashion. Polysomnography was performed accompanied by measurements of skin-, core body- and mattress surface-temperatures, and heart rate. EEG power spectral analyses were carried out using Fast Fourier Transform. Interbeat intervals were derived from the electrocardiogram. RESULTS The HM led to a larger decline in CBT, mediated through higher heat conduction from the core via the proximal back skin onto the mattress together with reduced heart rate. These effects occurred together with a significant increase in sleep stage N3 and standardized slow wave energy (sSWE, 0.791-4.297 Hz) accumulated in NREM sleep. In the 2nd half of the night sSWE increase was significantly correlated with body temperature changes, for example with CBT decline in the same phase. CONCLUSIONS A HM subtly decreases CBT, leading to an increased amount of sleep stage N3 and of sSWE, as well as a slowing of heart rate.",2020,"These effects occurred together with a significant increase in sleep stage N3 and standardized slow wave energy (sSWE, 0.791-4.297Hz) accumulated in NREM sleep.",[],"['conventional low-heat capacity mattress', 'slow (non-disturbing) reduction of core body temperature (CBT']","['CBT decline', 'sleep stage N3 and standardized slow wave energy (sSWE, 0.791-4.297Hz) accumulated in NREM sleep', 'heart rate']",[],"[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0024940', 'cui_str': 'Mattresses'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0456240', 'cui_str': 'Core body temperature (observable entity)'}]","[{'cui': 'C0037319', 'cui_str': 'Sleep Stages'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0234451', 'cui_str': 'Sleep, Slow-Wave'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",,0.0270784,"These effects occurred together with a significant increase in sleep stage N3 and standardized slow wave energy (sSWE, 0.791-4.297Hz) accumulated in NREM sleep.","[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Herberger', 'Affiliation': 'Interdisciplinary Center of Sleep Medicine, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Kräuchi', 'Affiliation': 'Psychiatric University Clinics, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Glos', 'Affiliation': 'Interdisciplinary Center of Sleep Medicine, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Lederer', 'Affiliation': 'Advanced Sleep Research GmbH, Berlin, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Assmus', 'Affiliation': 'Interdisciplinary Center of Sleep Medicine, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Hein', 'Affiliation': 'Interdisciplinary Center of Sleep Medicine, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Penzel', 'Affiliation': 'Interdisciplinary Center of Sleep Medicine, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Fietze', 'Affiliation': 'Interdisciplinary Center of Sleep Medicine, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}]",Sleep,['10.1093/sleep/zsz271'] 375,30654026,An addiction-based mobile health weight loss intervention: protocol of a randomized controlled trial.,"BACKGROUND The notion of obesity as an addictive process is controversial. However, studies show that between 5.9 and 30.7% of adolescents with obesity report food or eating addiction. Few weight management interventions have tested techniques based on addiction medicine principles. METHODS This multi-center randomized control trial (RCT) is designed to test the effectiveness of a mobile health (mHealth) weight-loss intervention based on addiction principles, such as withdrawal and tolerance, in a sample of 180 adolescents (ages 14-18) recruited from four pediatric weight management clinics in Southern California. Akin to a Multiphase Optimization Strategy (MOST) design evaluating multicomponent behavioral interventions, we will compare the combination of an app + phone coaching (App+Coach) to app alone (App) and in-clinic multi-disciplinary (Clinic) intervention arms. The primary outcome is mean change in zBMI and %BMI p95 over 18 months. We hypothesize that youth who receive App+Coach will have a greater reduction in body weight over the 18-month study period at a lower cost than standard of care models. Secondary outcomes include adherence to treatment regimen, intervention satisfaction, effect of the intervention on metabolic factors and activity level. We will also explore potential moderators of intervention effectiveness such as addictive eating habits, self-regulation and executive functioning. CONCLUSIONS New and creative approaches are needed to address pediatric obesity. If successful, this RCT may provide an innovative and cost-effective mHealth approach, based on addiction methods, for weight loss among adolescents with overweight and obesity.",2019,"We will also explore potential moderators of intervention effectiveness such as addictive eating habits, self-regulation and executive functioning. ","['adolescents with obesity report food or eating addiction', '180 adolescents (ages 14-18) recruited from four pediatric weight management clinics in Southern California', 'adolescents with overweight and obesity']","['App+Coach', 'mobile health (mHealth) weight-loss intervention', 'app + phone coaching (App+Coach) to app alone (App) and in-clinic multi-disciplinary (Clinic) intervention']","['mean change in zBMI and %BMI p95', 'adherence to treatment regimen, intervention satisfaction, effect of the intervention on metabolic factors and activity level', 'body weight']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",180.0,0.108278,"We will also explore potential moderators of intervention effectiveness such as addictive eating habits, self-regulation and executive functioning. ","[{'ForeName': 'Alaina P', 'Initials': 'AP', 'LastName': 'Vidmar', 'Affiliation': ""Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, Department of Pediatrics, Children's Hospital Los Angeles and Keck School of Medicine of USC, Los Angeles, CA, United States. Electronic address: avidmar@chla.usc.edu.""}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Salvy', 'Affiliation': 'Department of Medicine, Cedars-Sinai Medical Center, Research Center for Health Equity Samuel Oschin Comprehensive Cancer Institute, Los Angeles, CA, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pretlow', 'Affiliation': 'eHealth International Inc., Seattle, WA, United States.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Mittelman', 'Affiliation': ""Department of Pediatrics, Division of Endocrinology at the UCLA Children's Discovery and Innovation Institute, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, United States.""}, {'ForeName': 'Choo Phei', 'Initials': 'CP', 'LastName': 'Wee', 'Affiliation': 'CTSI Biostatics Core, Saban Research Institute, Los Angeles, CA, United States.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Fink', 'Affiliation': ""Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, Department of Pediatrics, Children's Hospital Los Angeles and Keck School of Medicine of USC, Los Angeles, CA, United States.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Steven Fox', 'Affiliation': 'Department of Pharmaceutical and Health Economics, School of Pharmacy of the University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Raymond', 'Affiliation': ""Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, Department of Pediatrics, Children's Hospital Los Angeles and Keck School of Medicine of USC, Los Angeles, CA, United States.""}]",Contemporary clinical trials,['10.1016/j.cct.2019.01.008'] 376,32107269,"Electroacupuncture for treatment-resistant insomnia: study protocol for a randomised, controlled, assessor-blinded, pilot clinical trial.","INTRODUCTION A considerable number of insomnia patients experience sleep disturbance even with long-term use of hypnotic medication. Previous studies have indicated that electroacupuncture (EA) could be an efficacious treatment for managing insomnia. However, few trials have been conducted to evaluate the effectiveness and safety of EA for treatment-resistant insomnia. This pilot study aims to explore the feasibility and preliminary effectiveness and safety of EA as an adjunct treatment for treatment-resistant insomnia. METHODS AND ANALYSIS This is a multicentre, randomised, usual care controlled and assessor-blinded pilot study protocol. Fifty patients presenting with sleep problems who have been taking hypnotic medication for more than 3 months will be randomly allocated to either an EA group or a usual care group at a 1:1 ratio. The EA group will undergo 12 EA treatment sessions twice a week for 6 weeks whereas the usual care group will not receive EA treatment. All the participants will receive a brochure containing educational information on sleep hygiene. The primary outcome will be the measured mean change of the total score of the Insomnia Severity Index from the baseline to week 7. The secondary outcome regarding sleep quality will be measured using the Pittsburgh Sleep Quality Index, a sleep diary and actigraphy. Moreover, we will assess the quality of life, the direct and indirect cost of treating insomnia for economic evaluation. After 4 weeks, the subjects will visit the research sites for a follow-up assessment. ETHICS AND DISSEMINATION Ethical approval of this study protocol was established by the institutional review boards of the each involved study site. All potential subjects will be provided written informed consent. The results of this study will be accessible in peer-reviewed publications and be presented at academic conference. TRIAL REGISTRATION NUMBER KCT0003235.",2020,The primary outcome will be the measured mean change of the total score of the Insomnia Severity Index from the baseline to week 7.,['Fifty patients presenting with sleep problems who have been taking hypnotic medication for more than 3 months'],"['Electroacupuncture', 'usual care group will not receive EA treatment', 'EA', 'brochure containing educational information', 'electroacupuncture (EA', 'EA group or a usual care']","['mean change of the total score of the Insomnia Severity Index', 'quality of life', 'sleep quality will be measured using the Pittsburgh Sleep Quality Index, a sleep diary and actigraphy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0020591', 'cui_str': 'Hypnotics'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}, {'cui': 'C0034380'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}]",50.0,0.115802,The primary outcome will be the measured mean change of the total score of the Insomnia Severity Index from the baseline to week 7.,"[{'ForeName': 'Jung-Hwa', 'Initials': 'JH', 'LastName': 'Lim', 'Affiliation': 'Department of Neuropsychiatry, School of Korean Medicine, Pusan National University, Yangsan-si, Gyeongsanganm-do, Korea (the Republic of).'}, {'ForeName': 'Kyung-Ok', 'Initials': 'KO', 'LastName': 'Kim', 'Affiliation': 'Department of Oriental Neuropsychiatry, Dongshin University College of Korean Medicine, Gwangju, Korea (the Republic of).'}, {'ForeName': 'Sang-Ho', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Neuropsychiatry of Korean Medicine, Pohang Korean Medicine Hospital, Daegu Haany University College of Oriental Medicine, Pohang-si, Gyeongsangbuk-do, Korea (the Republic of).'}, {'ForeName': 'Chang-Wan', 'Initials': 'CW', 'LastName': 'Kang', 'Affiliation': 'Division of Industrial Convergence System Engineering, Dong Eui University, Busan, Busan, Korea (the Republic of).'}, {'ForeName': 'Bo-Kyung', 'Initials': 'BK', 'LastName': 'Kim', 'Affiliation': 'Department of Neuropsychiatry, School of Korean Medicine, Pusan National University, Yangsan-si, Gyeongsanganm-do, Korea (the Republic of) npjolie@hanmail.net.'}]",BMJ open,['10.1136/bmjopen-2019-034239'] 377,29536428,Culturally Adapted CBTI for Chinese Insomnia Patients: a One-Arm Pilot Trial.,"PURPOSE Insomnia is a common mental disorder with severe consequences. Cognitive-behavioral therapy for insomnia (CBTI) has been proved effective against insomnia, but most of the research is limited to Western countries. This trial objective is to develop a Chinese culture-adapted CBTI program and assess its efficacy. METHOD An 8-week culturally adapted CBTI program was developed that included mixed group and individual session and culturally adapted relaxation and cognitive restructuring treatment components. A one-arm clinical trial was conducted at a public hospital between March 2016 and January 2017. Seventy-two Chinese adults (15 males, 57 females; mean age, 50 years) with insomnia disorder underwent the culturally adapted CBTI program. Sleep diaries and self-report scales, as well as polysomnography (PSG, for a subgroup only), were used to assess qualitative and quantitative measures of sleep, mental health status, and quality of life at baseline, post-treatment, and 4-month follow-up. RESULTS Pre-post analyses showed significant changes in sleep diary sleep onset latency (SOL), wake after sleep onset (WASO), and total sleep time of respectively - 37.03 min (CI, - 48.90 to - 25.16), - 28.16 min (CI, - 40.22 to - 16.10), and + 27.49 min (CI, 10.51 to 44.47). Self-reported sleep quality, mental health, and quality of life improved compared to baseline. The self-reported outcomes were mainly stable at follow-up. PSG outcomes globally failed to show improvement. CONCLUSION The design of a CBTI program adapted to Chinese population was achieved. Culturally adapted CBTI showed promising results. More rigorously designed studies are needed to ensure efficacy.",2018,"Self-reported sleep quality, mental health, and quality of life improved compared to baseline.","['insomnia (CBTI', 'Chinese Insomnia Patients', 'Seventy-two Chinese adults (15 males, 57 females; mean age, 50\xa0years', 'public hospital between March 2016 and January 2017']","['culturally adapted CBTI program', 'Cognitive-behavioral therapy', 'Chinese culture-adapted CBTI program']","['qualitative and quantitative measures of sleep, mental health status, and quality of life', 'Sleep diaries and self-report scales', 'Self-reported sleep quality, mental health, and quality of life', 'sleep diary sleep onset latency (SOL), wake after sleep onset (WASO), and total sleep time']","[{'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0220814', 'cui_str': 'culture'}]","[{'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",72.0,0.054554,"Self-reported sleep quality, mental health, and quality of life improved compared to baseline.","[{'ForeName': 'Yoann', 'Initials': 'Y', 'LastName': 'Birling', 'Affiliation': ""Guang'an Men Hospital, Beijing, 100053, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Guang'an Men Hospital, Beijing, 100053, China. wjmd@263.net.""}, {'ForeName': 'Guixia', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': ""Guang'an Men Hospital, Beijing, 100053, China.""}, {'ForeName': 'Enlai', 'Initials': 'E', 'LastName': 'Wu', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, 100049, China.'}, {'ForeName': 'Zhidan', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, 100049, China.'}, {'ForeName': 'Yunshu', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': ""Guang'an Men Hospital, Beijing, 100053, China.""}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, 100049, China.'}]",International journal of behavioral medicine,['10.1007/s12529-017-9710-z'] 378,31691621,"Effectiveness of the short-term use of Cimicifuga racemosa in the endothelial function of postmenopausal women: a double-blind, randomized, controlled trial.","Objective: This study aimed to assess the effects of daily use of Cimicifuga racemosa on endothelial function through flow-mediated dilation of the brachial artery, when used for 28 days by healthy postmenopausal women. Methods: The double-blind, randomized, placebo-controlled study included two groups of postmenopausal women ( n  = 31 each). The subjects were clinically assessed and flow-mediated dilation of the brachial artery was measured before and after 28 days of treatment. Patients received dry extract corresponding to 160 mg C. racemosa (extract with 4 mg of triterpene glycosides) or placebo. Results: Mean age, time since menopause, and body mass index in the two groups were similar. The measurements of flow-mediated dilation of the brachial artery, pre and post treatment, respectively, showed a significant increase in patients who used C. racemosa ( p  = 0.006), unlike patients who used placebo, who did not present changes in the outcome of flow-mediated dilation of the brachial artery after 28 days of use ( p  ≥ 0.05). When comparing the number of women in both groups who showed an increase in flow-mediated dilation, a significant difference was found in the measurements of the treated group after the use of the medication ( p  = 0.018). Conclusions: Daily use of 160 mg C. racemosa extract by postmenopausal women for 28 days beneficially influences endothelial function by promoting elasticity of the brachial artery.",2020,"The measurements of flow-mediated dilation of the brachial artery, pre and post treatment, respectively, showed a significant increase in patients who used C. racemosa ( p  = 0.006), unlike patients who used placebo, who did not present changes in the outcome of flow-mediated dilation of the brachial artery after 28 days of use ( p  ≥ 0.05).","['160', 'postmenopausal women', '28\u2009days by healthy postmenopausal women', 'two groups of postmenopausal women ( n \u2009=\u200931 each']","['dry extract corresponding to 160', 'mg C. racemosa (extract with 4\u2009mg of triterpene glycosides) or placebo', 'Cimicifuga racemosa', 'placebo', 'short-term use of Cimicifuga racemosa']","['outcome of flow-mediated dilation of the brachial artery', 'flow-mediated dilation', 'flow-mediated dilation of the brachial artery', 'Mean age, time since menopause, and body mass index', 'endothelial function']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1720167', 'cui_str': 'Dry extract (qualifier value)'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0041113', 'cui_str': 'Triterpenes'}, {'cui': 'C0007158', 'cui_str': 'Cardiotonic Steroids'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0885226', 'cui_str': 'Cimicifuga racemosa'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}]","[{'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0006087', 'cui_str': 'Brachial Artery'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0567312', 'cui_str': 'Menopause present (finding)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.342591,"The measurements of flow-mediated dilation of the brachial artery, pre and post treatment, respectively, showed a significant increase in patients who used C. racemosa ( p  = 0.006), unlike patients who used placebo, who did not present changes in the outcome of flow-mediated dilation of the brachial artery after 28 days of use ( p  ≥ 0.05).","[{'ForeName': 'E S', 'Initials': 'ES', 'LastName': 'Fernandes', 'Affiliation': 'Department of Obstetrics and Gynecology, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'M F S', 'Initials': 'MFS', 'LastName': 'Celani', 'Affiliation': 'Department of Obstetrics and Gynecology, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fistarol', 'Affiliation': 'Department of Obstetrics and Gynecology, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Geber', 'Affiliation': 'Department of Obstetrics and Gynecology, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}]",Climacteric : the journal of the International Menopause Society,['10.1080/13697137.2019.1682542'] 379,23681505,Efficacy and safety of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder and recent methylphenidate use.,"INTRODUCTION Lisdexamfetamine dimesylate (LDX) is a long-acting prodrug stimulant for the treatment of attention-deficit/hyperactivity disorder (ADHD). Post hoc subgroup analyses were performed from two studies in children with ADHD to compare the efficacy of LDX in participants who had received prior methylphenidate (MPH) treatment with that of the overall study populations. METHODS Study 1 (7-week; open-label design) and study 2 (randomized, double-blind, placebo-controlled, crossover, laboratory school design) enrolled children aged 6-12 years with ADHD and baseline ADHD Rating Scale IV (ADHD-RS-IV) total score ≥28. Both studies excluded children whose prestudy ADHD treatment provided effective control of ADHD symptoms with an acceptable safety profile. Post hoc efficacy analyses were performed in children who had received MPH within 6 months of study enrollment. Efficacy measures included the following scales: ADHD-RS-IV, Clinical Global Impressions-Improvement (CGI-I), Expression and Emotion Scale for Children (EESC), Behavior Rating Inventory of Executive Function (BRIEF), Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP), and Permanent Product Measure of Performance (PERMP). RESULTS In studies 1 and 2, 83/318 (26%) and 67/129 (52%) participants, respectively, had received MPH within 6 months and were not adequately controlled on current medication with acceptable tolerability; most of these participants had received long-acting MPH. In prior MPH participants, efficacy assessments demonstrated improvements from baseline (study 1) and versus placebo (study 2) that were comparable with those seen in the respective overall study population. Safety profiles were consistent with long-acting stimulant use. CONCLUSION In two studies, children who had received prior MPH treatment improved during treatment with LDX and experienced similar improvements in their symptoms as the overall study populations. For children with ADHD who were previously treated with MPH, LDX may, therefore, be an efficacious treatment option.",2013,"In prior MPH participants, efficacy assessments demonstrated improvements from baseline (study 1) and versus placebo (study 2) that were comparable with those seen in the respective overall study population.","['For children with ADHD', 'children aged 6-12 years with ADHD and baseline ADHD Rating Scale IV', 'children with attention-deficit/hyperactivity disorder and recent methylphenidate use', 'participants who had received prior methylphenidate (MPH) treatment with that of the overall study populations']","['LDX', 'placebo', 'MPH, LDX', 'Lisdexamfetamine dimesylate (LDX', 'lisdexamfetamine dimesylate']","['EESC), Behavior Rating Inventory of Executive Function (BRIEF), Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP), and Permanent Product Measure of Performance ', 'Efficacy and safety', 'scales: ADHD-RS-IV, Clinical Global Impressions-Improvement (CGI-I), Expression and Emotion Scale for Children']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C1739826', 'cui_str': 'lisdexamfetamine dimesylate'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0222045'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",,0.177532,"In prior MPH participants, efficacy assessments demonstrated improvements from baseline (study 1) and versus placebo (study 2) that were comparable with those seen in the respective overall study population.","[{'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Jain', 'Affiliation': 'R/D Clinical Research, Inc, 461 This Way, Lake Jackson, TX 77566, USA. jaintexas@gmail.com'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Babcock', 'Affiliation': ''}, {'ForeName': 'Teodor', 'Initials': 'T', 'LastName': 'Burtea', 'Affiliation': ''}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Dirks', 'Affiliation': ''}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Adeyi', 'Affiliation': ''}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Scheckner', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lasser', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Renna', 'Affiliation': ''}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Duncan', 'Affiliation': ''}]",Advances in therapy,['10.1007/s12325-013-0027-2'] 380,24777691,Safety and efficacy of colesevelam HCl in the treatment of elderly patients.,"BACKGROUND AND OBJECTIVES Colesevelam significantly lowers cholesterol in patients with hypercholesterolemia, and both cholesterol and hemoglobin A1C (A1C) in patients with type 2 diabetes mellitus (T2DM). The purpose of this post hoc analysis was to evaluate the efficacy and safety/tolerability of colesevelam in older (≥65 years) and younger (<65 years) adults. METHODS We conducted post hoc analyses of pooled clinical trial data from seven phase II and III randomized, double-blind, placebo-controlled, primary hyperlipidemia and T2DM clinical trials. The hyperlipidemia safety/tolerability analysis included seven studies (≥65 years, n = 154; <65 years, n = 381); the efficacy analysis utilized one study with sufficient patients in both age groups for meaningful comparison. The T2DM analyses included four studies (safety/tolerability: ≥65 years, n = 249; <65 years, n = 880) or three studies (efficacy). In the hyperlipidemia studies, patients received colesevelam 1.5-4.5 g/day or placebo, alone or with a statin, for 4 weeks to 6 months. In the T2DM studies, colesevelam 3.75 g/day or placebo was added to existing antidiabetes therapies for 16 or 26 weeks. Low-density lipoprotein cholesterol (LDL-C), A1C, and adverse events were assessed. RESULTS In the hyperlipidemia analysis, colesevelam versus placebo produced similar mean reductions from baseline in LDL-C in older (-16.6 vs. +0.5 %) and younger (-13.7 vs. +0.4 %) patients. In the T2DM analysis, older and younger patients had similar reductions from baseline in A1C (treatment difference -0.59 and -0.54 %, respectively; both p < 0.001) and LDL-C (-14.7 and -15.5 %, respectively; both p < 0.001) with colesevelam. In both analyses, adverse event incidence was generally similar between subgroups. In the T2DM analysis, hypoglycemia was slightly more frequent with colesevelam versus placebo in older patients (5.8 vs. 2.3 %); no reports of hypoglycemia were considered serious adverse events. CONCLUSIONS In primary hyperlipidemia and in T2DM, colesevelam appeared to be generally as safe, well tolerated, and efficacious in patients aged ≥65 years as in those aged <65 years.",2014,"In primary hyperlipidemia and in T2DM, colesevelam appeared to be generally as safe, well tolerated, and efficacious in patients aged ≥65 years as in those aged <65 years.","['≥65\xa0years, n\xa0=\xa0249; <65\xa0years, n\xa0=\xa0880) or three studies (efficacy', 'seven studies (≥65\xa0years, n\xa0=\xa0154; <65\xa0years, n\xa0=\xa0381', 'older (≥65\xa0years) and younger (<65\xa0years) adults', 'patients aged ≥65\xa0years as in those aged <65\xa0years', 'patients with hypercholesterolemia, and both cholesterol and hemoglobin A1C (A1C) in patients with type 2 diabetes mellitus (T2DM', 'elderly patients']","['placebo, alone or with a statin', 'placebo', 'colesevelam HCl']","['Low-density lipoprotein cholesterol (LDL-C), A1C, and adverse events', 'efficacy and safety/tolerability', 'hypoglycemia', 'adverse event incidence', 'Safety and efficacy', 'hyperlipidemia safety/tolerability', 'LDL-C', 'safety/tolerability']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C4708787', 'cui_str': '381 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0541154', 'cui_str': 'Colesevelam hydrochloride'}]","[{'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipemia'}]",,0.186424,"In primary hyperlipidemia and in T2DM, colesevelam appeared to be generally as safe, well tolerated, and efficacious in patients aged ≥65 years as in those aged <65 years.","[{'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Gavin', 'Affiliation': 'Healing Our Village, Inc., 145 Bayberry Run, Fayetteville, GA, 30214, USA, jrgavin3@yahoo.com.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Ford', 'Affiliation': ''}, {'ForeName': 'Kenneth E', 'Initials': 'KE', 'LastName': 'Truitt', 'Affiliation': ''}]",Drugs & aging,['10.1007/s40266-014-0174-4'] 381,30622317,Nebivolol reduces short-term blood pressure variability more potently than irbesartan in patients with intradialytic hypertension.,"Increased blood pressure (BP) variability (BPV) is associated with high cardiovascular risk in hemodialysis. Studies on the effects of antihypertensive drugs on BPV in hemodialysis are scarce. This study examines the effects of nebivolol and irbesartan on short-term BPV in patients with intradialytic hypertension. This randomized-cross-over study included 38 patients (age: 60.4 ± 11.1 years, male: 65.8%) with intradialytic hypertension (intradialytic-SBP increase ≥ 10 mmHg at ≥4 over 6 consecutive sessions). After the baseline evaluation, participants were randomized to nebivolol 5 mg and subsequently irbesartan 150 mg, or vice versa, with a two-week wash-out period before initiation of the second drug. Patients underwent three respective 24 h-ABPM sessions starting before a midweek-session. We calculated the standard deviation (SD), weighted SD (wSD), coefficient of variation (CV), and average real variability (ARV) of BP with validated formulas. The post-hemodialysis and 24 h-SBP and DBP levels were significantly lower after treatment with both drugs. The systolic-BPV indices were marginally lower after nebivolol but not after irbesartan compared to baseline (SD: baseline 15.70 ± 4.69; nebivolol 14.45 ± 3.37, p = 0.090; irbesartan 15.39 ± 3.85, p = 0.706; wSD: 14.62 ± 4.36 vs 13.40 ± 3.07, p = 0.053 vs 14.36 ± 3.47, p = 0.805, respectively). The diastolic-BPV indices decreased with nebivolol and increased with irbesartan, resulting in significant differences between the two drugs (SD: baseline 10.56 ± 2.50; nebivolol 9.75 ± 2.12; irbesartan 10.84 ± 1.98, between-drug p = 0.014; wSD: baseline 9.86 ± 2.12; nebivolol 9.34 ± 2.01; irbesartan 10.25 ± 2.01, between-drug p = 0.029). The diastolic-BPV during intradialytic and day-time periods was marginally lower with nebivolol than with irbesartan. During nighttime, the BPV indices were unchanged with either drug. The short-term BPV was reduced after nebivolol but not after irbesartan treatment in patients with intradialytic hypertension. These findings suggest that sympathetic-overdrive may be a major factor that affects BPV in intradialytic hypertension patients.",2019,"The systolic-BPV indices were marginally lower after nebivolol but not after irbesartan compared to baseline (SD: baseline 15.70 ± 4.69; nebivolol 14.45 ± 3.37, p = 0.090; irbesartan 15.39 ± 3.85, p = 0.706; wSD: 14.62 ± 4.36 vs 13.40 ± 3.07, p = 0.053 vs 14.36 ± 3.47, p = 0.805, respectively).","['38 patients (age: 60.4\u2009±\u200911.1 years, male: 65.8%) with intradialytic hypertension (intradialytic-SBP increase\u2009≥\u200910\u2009mmHg at ≥4 over 6 consecutive sessions', 'intradialytic hypertension patients', 'patients with intradialytic hypertension']","['Nebivolol', 'nebivolol', 'nebivolol and irbesartan', 'nebivolol 5\u2009mg and subsequently irbesartan 150\u2009mg, or vice versa']","['blood pressure (BP) variability (BPV', 'diastolic-BPV indices', 'BPV indices', 'SBP and DBP levels', 'short-term BPV', 'diastolic-BPV during intradialytic and day-time periods', 'standard deviation (SD), weighted SD (wSD), coefficient of variation (CV), and average real variability (ARV) of BP with validated formulas', 'systolic-BPV indices']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}]","[{'cui': 'C0068475', 'cui_str': 'nebivolol'}, {'cui': 'C0288171', 'cui_str': 'irbesartan'}, {'cui': 'C1306211', 'cui_str': 'nebivolol 5 MG'}, {'cui': 'C0986849', 'cui_str': 'irbesartan 150 MG'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0531207', 'cui_str': 'bpV(phen)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1948053', 'cui_str': 'Time periods (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",38.0,0.0273608,"The systolic-BPV indices were marginally lower after nebivolol but not after irbesartan compared to baseline (SD: baseline 15.70 ± 4.69; nebivolol 14.45 ± 3.37, p = 0.090; irbesartan 15.39 ± 3.85, p = 0.706; wSD: 14.62 ± 4.36 vs 13.40 ± 3.07, p = 0.053 vs 14.36 ± 3.47, p = 0.805, respectively).","[{'ForeName': 'Charalampos', 'Initials': 'C', 'LastName': 'Loutradis', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Bikos', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Vassilios', 'Initials': 'V', 'LastName': 'Raptis', 'Affiliation': 'Pieria Hemodialysis Unit, Katerini, Greece.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Afkou', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Tzanis', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Pyrgidis', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Stylianos', 'Initials': 'S', 'LastName': 'Panagoutsos', 'Affiliation': 'Department of Nephrology, General Hospital of Alexandroupolis, Alexandroupolis, Greece.'}, {'ForeName': 'Ploumis', 'Initials': 'P', 'LastName': 'Pasadakis', 'Affiliation': 'Department of Nephrology, General Hospital of Alexandroupolis, Alexandroupolis, Greece.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Balaskas', 'Affiliation': 'Section of Nephrology and Hypertension, 1st Department of Medicine, AHEPA Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Pantelis', 'Initials': 'P', 'LastName': 'Zebekakis', 'Affiliation': 'Section of Nephrology and Hypertension, 1st Department of Medicine, AHEPA Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Vassilios', 'Initials': 'V', 'LastName': 'Liakopoulos', 'Affiliation': 'Section of Nephrology and Hypertension, 1st Department of Medicine, AHEPA Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Aikaterini', 'Initials': 'A', 'LastName': 'Papagianni', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Gianfranco', 'Initials': 'G', 'LastName': 'Parati', 'Affiliation': 'Istituto Auxologico Italiano, IRCCS, Department of Cardiovascular, Neural and Metabolic Sciences, S.Luca Hospital, Milan, Italy.'}, {'ForeName': 'Pantelis', 'Initials': 'P', 'LastName': 'Sarafidis', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece. psarafidis11@yahoo.gr.'}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-018-0194-2'] 382,31677046,The EffectiveNess of LIfestyle with Diet and Physical Activity Education ProGram Among Prehypertensives and Stage 1 HyperTENsives in an Urban Community Setting (ENLIGHTEN) Study.,"This study aims to determine the effectiveness of a monthly lifestyle education program, which included advice on nutritional changes and physical activity enhancement in the reduction of blood pressure and selected biochemical and anthropometric parameters among pre-hypertensive and stage 1 hypertensive participants in Manila, Philippines. Participants resided in two barangays (districts), in Manila, Philippines, and each barangay was assigned to either the intervention or attention-control group. The intervention group received monthly lectures on cardiovascular disease and organized classes on diet and exercise, while the attention-control group received monthly lectures on non-cardiovascular topics, with verbal advice that healthy diet and exercise are important. The primary outcome was systolic blood pressure, with secondary outcomes of BMI, waist circumference, and laboratory measures. Linear mixed effects models with an interaction between intervention group and time were used to estimate the 6-month change in each group. At 6 months, systolic blood pressure was lower in the intervention group compared to the attention-control group (- 12.7 mmHg (95% CI [- 14.5, - 10.9]) vs. - 0.24 mmHg (95% CI [- 1.87, 1.43]), p-value < 0.001). Waist circumference (p < 0.001), BMI (p < 0.001), and total cholesterol (p = 0.049) were also lower. However, no statistically significant difference in fasting glucose was observed between the two groups (p = 0.740). This study showed that participants receiving a non-pharmacological intervention, specifically a low-cost diet and active lifestyle education program, experienced a greater decrease in blood pressure, BMI, waist circumference, and total cholesterol than the attention-control group. Educational programs such as in ENLIGHTEN show promise for a developing country with limited resources to improve hypertension levels, and ultimately cardiovascular health. ENLIGHTEN deserves further study in randomized trials.",2020,"However, no statistically significant difference in fasting glucose was observed between the two groups (p = 0.740).","['pre-hypertensive and stage 1 hypertensive participants in Manila, Philippines', 'Prehypertensives and Stage 1 HyperTENsives in an Urban Community Setting (ENLIGHTEN) Study', 'participants receiving a non-pharmacological intervention, specifically a low-cost diet and active lifestyle education program']","['monthly lectures on cardiovascular disease and organized classes on diet and exercise, while the attention-control group received monthly lectures on non-cardiovascular topics, with verbal advice that healthy diet and exercise', 'LIfestyle with Diet and Physical Activity Education ProGram', 'intervention or attention-control group', 'monthly lifestyle education program']","['blood pressure, BMI, waist circumference, and total cholesterol', 'blood pressure and selected biochemical and anthropometric parameters', 'systolic blood pressure, with secondary outcomes of BMI, waist circumference, and laboratory measures', 'total cholesterol', 'Waist circumference', 'fasting glucose', 'BMI', 'systolic blood pressure']","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]",,0.0292947,"However, no statistically significant difference in fasting glucose was observed between the two groups (p = 0.740).","[{'ForeName': 'Julieta', 'Initials': 'J', 'LastName': 'Gabiola', 'Affiliation': 'Division of Primary Care and Population Health, Stanford University School of Medicine, 1265 Welch Road, MC 5475, Stanford, CA, 94305, USA.'}, {'ForeName': 'Dante', 'Initials': 'D', 'LastName': 'Morales', 'Affiliation': 'Manila Doctors Hospital, Manila, Philippines.'}, {'ForeName': 'Olive', 'Initials': 'O', 'LastName': 'Quizon', 'Affiliation': 'Manila Doctors Hospital, Manila, Philippines.'}, {'ForeName': 'Ronald Ian', 'Initials': 'RI', 'LastName': 'Cadiz', 'Affiliation': 'Manila Doctors Hospital, Manila, Philippines.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Feliciano', 'Affiliation': 'Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Roberto L', 'Initials': 'RL', 'LastName': 'Ruiz', 'Affiliation': 'Manila Doctors Hospital, Manila, Philippines.'}, {'ForeName': 'Christine Joy', 'Initials': 'CJ', 'LastName': 'Aguatis', 'Affiliation': 'Manila Doctors Hospital, Manila, Philippines.'}, {'ForeName': 'Teresita', 'Initials': 'T', 'LastName': 'Mararac', 'Affiliation': 'Manila Doctors Hospital, Manila, Philippines.'}, {'ForeName': 'Jenssy', 'Initials': 'J', 'LastName': 'Rojina', 'Affiliation': 'Oregon Health and Science University School of Medicine, Portland, OR, USA.'}, {'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Garcia', 'Affiliation': 'Quantitative Sciences Unit, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Hedlin', 'Affiliation': 'Quantitative Sciences Unit, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Cullen', 'Affiliation': 'Center for Population Health Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Latha', 'Initials': 'L', 'LastName': 'Palaniappan', 'Affiliation': 'Division of Primary Care and Population Health, Stanford University School of Medicine, 1265 Welch Road, MC 5475, Stanford, CA, 94305, USA. lathap@stanford.edu.'}]",Journal of community health,['10.1007/s10900-019-00764-0'] 383,28364446,"Randomized, Prospective Study of the Impact of a Sleep Health Program on Firefighter Injury and Disability.","Study Objectives Firefighters' schedules include extended shifts and long work weeks which cause sleep deficiency and circadian rhythm disruption. Many firefighters also suffer from undiagnosed sleep disorders, exacerbating fatigue. We tested the hypothesis that a workplace-based Sleep Health Program (SHP) incorporating sleep health education and sleep disorders screening would improve firefighter health and safety compared to standard practice. Design Prospective station-level randomized, field-based intervention. Setting US fire department. Participants 1189 firefighters. Interventions Sleep health education, questionnaire-based sleep disorders screening, and sleep clinic referrals for respondents who screened positive for a sleep disorder. Measurements and Results Firefighters were randomized by station. Using departmental records, in an intention-to-treat analysis, firefighters assigned to intervention stations which participated in education sessions and had the opportunity to complete sleep disorders screening reported 46% fewer disability days than those assigned to control stations (1.4 ± 5.9 vs. 2.6 ± 8.5 days/firefighter, respectively; p = .003). There were no significant differences in departmental injury or motor vehicle crash rates between the groups. In post hoc analysis accounting for intervention exposure, firefighters who attended education sessions were 24% less likely to file at least one injury report during the study than those who did not attend, regardless of randomization (OR [95% CI] 0.76 [0.60, 0.98]; χ2 = 4.56; p = .033). There were no significant changes pre- versus post-study in self-reported sleep or sleepiness in those who participated in the intervention. Conclusions A firefighter workplace-based SHP providing sleep health education and sleep disorders screening opportunity can reduce injuries and work loss due to disability in firefighters.",2017,"There were no significant changes pre- versus post-study in self-reported sleep or sleepiness in those who participated in the intervention. ","['respondents who screened positive for a sleep disorder', 'Participants\n\n\n1189 firefighters']","['Sleep Health Program', 'Interventions\n\n\nSleep health education, questionnaire-based sleep disorders screening, and sleep clinic referrals', 'workplace-based Sleep Health Program (SHP) incorporating sleep health education and sleep disorders screening']","['departmental injury or motor vehicle crash rates', 'sleep or sleepiness', 'Firefighter Injury and Disability']","[{'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}, {'cui': 'C0221459', 'cui_str': 'Fire and Rescue Personnel'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0018701'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0175845', 'cui_str': 'Motor Vehicles'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0221459', 'cui_str': 'Fire and Rescue Personnel'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",,0.0438442,"There were no significant changes pre- versus post-study in self-reported sleep or sleepiness in those who participated in the intervention. ","[{'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Sullivan', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, and the Sleep Health Institute, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Conor S', 'Initials': 'CS', 'LastName': ""O'Brien"", 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, and the Sleep Health Institute, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Barger', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, and the Sleep Health Institute, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Shantha M W', 'Initials': 'SM', 'LastName': 'Rajaratnam', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, and the Sleep Health Institute, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Czeisler', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, and the Sleep Health Institute, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Lockley', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, and the Sleep Health Institute, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Sleep,['10.1093/sleep/zsw001'] 384,23838841,"Safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple rising doses of empagliflozin in patients with type 2 diabetes mellitus.","INTRODUCTION This study examined the safety, tolerability, pharmacokinetics, and pharmacodynamics of empagliflozin, a potent and highly selective sodium glucose cotransporter 2 (SGLT2) inhibitor, in patients with type 2 diabetes mellitus (T2DM). METHODS A total of 48 patients with T2DM were randomized to receive one of four doses of empagliflozin (2.5, 10, 25, or 100 mg qd) or placebo over 8 days. In every dose group, nine patients received active drug and three received placebo. The primary endpoint was safety and tolerability. Pharmacokinetic and pharmacodynamic parameters were measured as secondary endpoints. RESULTS Empagliflozin was rapidly absorbed, reaching peak levels 1.5-3.0 h after dosing and showed a biphasic decline. The mean terminal elimination half-life ranged from 10 to 19 h. Increases in exposure (area under the plasma concentration-time curve [AUC] and maximum concentration of analyte in plasma [C max]) were approximately proportional with dose. Empagliflozin increased the rate and total amount of glucose excreted in urine compared to placebo. After administration of a single dose of empagliflozin, cumulative amounts of glucose excreted in urine over 24 h ranged from 46.3 to 89.8 g, compared with 5.84 g with placebo. Similar results were seen after multiple doses. Fasting plasma glucose levels decreased by 17.2-25.8% with empagliflozin and by 12.7% with placebo. The frequency of adverse events was 33.3-66.7% with empagliflozin and 41.7% with placebo. There were no changes in urine volume or micturition frequency under the controlled study conditions. CONCLUSION Overall, pharmacokinetic assessments demonstrated a dose-proportional increase in drug exposure and support once-daily dosing. Elevated urinary glucose excretion was observed with all doses. Multiple once-daily oral doses of empagliflozin (2.5-100 mg) reduced plasma glucose and were well tolerated in patients with T2DM. EudraCT (2007-000654-32).",2013,Fasting plasma glucose levels decreased by 17.2-25.8% with empagliflozin and by 12.7% with placebo.,"['patients with type 2 diabetes mellitus (T2DM', '48 patients with T2DM', 'patients with type 2 diabetes mellitus', 'patients with T2DM']","['EudraCT', 'Empagliflozin', 'empagliflozin', 'placebo']","['plasma glucose', 'safety and tolerability', 'Elevated urinary glucose excretion', 'exposure (area under the plasma concentration-time curve [AUC] and maximum concentration of analyte in plasma [C max', 'Safety, tolerability, pharmacokinetics, and pharmacodynamics', 'Fasting plasma glucose levels', 'urine volume or micturition frequency', 'safety, tolerability, pharmacokinetics, and pharmacodynamics', 'frequency of adverse events', 'cumulative amounts of glucose excreted in urine', 'mean terminal elimination half-life', 'rate and total amount of glucose excreted', 'Pharmacokinetic and pharmacodynamic parameters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0443354', 'cui_str': 'Analyte (substance)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1287298', 'cui_str': 'UO - Urine output'}, {'cui': 'C0042023', 'cui_str': 'Increased frequency of urination (finding)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0042037'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",48.0,0.121138,Fasting plasma glucose levels decreased by 17.2-25.8% with empagliflozin and by 12.7% with placebo.,"[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Heise', 'Affiliation': 'Profil Institut für Stoffwechselforschung GmbH, Hellersbergstrasse 9, 41460, Neuss, Germany, tim.heise@profil.com.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Seman', 'Affiliation': ''}, {'ForeName': 'Sreeraj', 'Initials': 'S', 'LastName': 'Macha', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Marquart', 'Affiliation': ''}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Pinnetti', 'Affiliation': ''}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Woerle', 'Affiliation': ''}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Dugi', 'Affiliation': ''}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-013-0030-2'] 385,30222495,Comparative Effects of Tensioning and Sliding Neural Mobilization on Static Postural Control and Lower Limb Hop Testing in Football Players.,"CONTEXT Sliding and tensioning neural mobilization are used to restore normal function of the nervous system, but they impose different stresses on it. Particularly, sliding induces greater nerve excursion than tensioning. Conceivably, they might impact nervous system function differently. OBJECTIVE To compare the effects of tensioning neural mobilization versus sliding neural mobilization of the dominant lower limb on static postural control and hop testing. DESIGN Randomized, parallel and double blinded trial. SETTING/PARTICIPANTS Thirty-seven football players. INTERVENTION(S) Participants were randomized into 2 groups: sliding neural mobilization (n = 18) or tensioning neural mobilization (n = 19) targeting the tibial nerve. MAIN OUTCOME MEASURES Static postural sway was assessed with a force plate and functional performance with hop tests. Measurements were taken at baseline, after the intervention, and at 30-minute follow-up. RESULTS There was a significant effect of time for the center of pressure total displacement and velocity (P < .05), for the single-leg hop test (P < .05), the 6-m timed hop test (P < .05), and the cross-over hop test (P < .05), but no significant effect of the intervention. CONCLUSIONS Sliding and tensioning neural mobilization improved postural control and hop testing in football players, and improvements remained 30 minutes after the intervention. Additional research examining the influence of neural mobilization on sensory motor impairments, postural control, and functional performance is needed.",2019,"There was a significant effect of time for the center of pressure total displacement and velocity (P < .05), for the single-leg hop test (P < .05), the 6-m timed hop test (P < .05), and the cross-over hop test (P < .05), but no significant effect of the intervention. ","['Football Players', 'Thirty-seven football players']","['Sliding and tensioning neural mobilization', 'Tensioning and Sliding Neural Mobilization', 'tensioning neural mobilization versus sliding neural mobilization', 'sliding neural mobilization (n\u2009=\u200918) or tensioning neural mobilization (n\u2009=\u200919) targeting the tibial nerve']","['pressure total displacement and velocity', 'Static postural sway']","[{'cui': 'C0336986', 'cui_str': 'Football'}, {'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}]","[{'cui': 'C0332246', 'cui_str': 'Sliding (qualifier value)'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0040186', 'cui_str': 'Tibial Nerve'}]","[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}]",,0.0502038,"There was a significant effect of time for the center of pressure total displacement and velocity (P < .05), for the single-leg hop test (P < .05), the 6-m timed hop test (P < .05), and the cross-over hop test (P < .05), but no significant effect of the intervention. ","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ferreira', 'Affiliation': ''}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Bebiano', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Raro', 'Affiliation': ''}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Martins', 'Affiliation': ''}, {'ForeName': 'Anabela G', 'Initials': 'AG', 'LastName': 'Silva', 'Affiliation': ''}]",Journal of sport rehabilitation,['10.1123/jsr.2017-0374'] 386,30335712,Web-Based Exercise Program Increases Cervical Strength in Adolescent Athletes.,"ABSTRACT Wilson, JC, Levek, C, Daoud, AK, Brewer, M, Brooks, K, Sochanska, A, Randall, M, and Provance, AJ. Web-based exercise program increases cervical strength in adolescent athletes. J Strength Cond Res 35(4): 1149-1155, 2021-This cohort study aimed to evaluate the efficacy of a web-based 6-week cervical strengthening program on cervical strength in adolescent athletes. It was hypothesized that subjects completing the program would demonstrate significant increase in cervical muscle strength compared with baseline strength. Eighty-three high school soccer athlete subjects were recruited from 2 local nationally competitive soccer clubs. Teams were assigned to either control or intervention groups to minimize information crossover. Fifty subjects were recruited to the intervention group (29 male, 21 female; average age 15.1 years). Thirty-three subjects were recruited to the control group (21 male, 12 female; average age 15.1 years). Intervention group subjects completed a web-based progressive cervical strengthening program over 6 weeks. Cervical strength in flexion, extension, right and left lateral flexion (LLF) was measured in Newton (N) of force at 3 time points during the competitive season for both control and intervention groups. Intervention group subjects significantly increased cervical strength [mean difference (95% confidence interval)] in LLF [24.1 (15.9-32.4)], extension [27.9 (18.4-37.5)], right lateral flexion [18.8 (11.6-26.1)], and flexion [mean ratio: 1.2 (1.1-1.2)] at follow-up testing; whereas control subjects did not see significant changes in strength. A web-based progressive cervical strengthening program improves cervical muscular strength in a population of adolescent athletes over a period of 6 weeks. Such a program could be used by researchers in future studies evaluating the influence on concussion risk and by practitioners as a means of reducing sport-related head and neck injuries.",2021,"Intervention group participants significantly increased cervical strength [mean difference (95% confidence interval)] in LLF [24.1 (15.9-32.4)], extension [27.9 (18.4-37.5)], right lateral flexion [18.8 (11.6-26.1)], and flexion [mean ratio: 1.2 (1.1-1.2)] at follow-up testing; whereas control participants did not see significant changes in strength.","['Eighty-three high school soccer athlete subjects were recruited from 2 local nationally competitive soccer clubs', 'adolescent athletes', 'Fifty subjects were recruited to the intervention group (29 male, 21 female; average age 15.1 years', 'Adolescent Athletes', 'Thirty-three subjects were recruited to the control group (21 male, 12 female; average age 15.1 years']","['Web-Based Exercise Program', 'web-based 6-week cervical strengthening program', 'J Strength Cond Res XX(X', 'web-based progressive cervical strengthening program', 'Web-based exercise program', 'progressive cervical strengthening program']","['cervical muscular strength', 'strength', 'right lateral flexion', 'Wilson, JC, Levek, C, Daoud, AK, Brewer, M, Brooks, K, Sochanska, A, Randall, M, and Provance, AJ', 'cervical muscle strength', 'cervical strength', 'Cervical strength in flexion, extension, right and left lateral flexion (LLF']","[{'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}]","[{'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0450415', 'cui_str': 'Lateral to the right (qualifier value)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0402217', 'cui_str': 'Brewer (occupation)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0439791', 'cui_str': 'Lateral flexion, function (observable entity)'}]",33.0,0.0252415,"Intervention group participants significantly increased cervical strength [mean difference (95% confidence interval)] in LLF [24.1 (15.9-32.4)], extension [27.9 (18.4-37.5)], right lateral flexion [18.8 (11.6-26.1)], and flexion [mean ratio: 1.2 (1.1-1.2)] at follow-up testing; whereas control participants did not see significant changes in strength.","[{'ForeName': 'Julie C', 'Initials': 'JC', 'LastName': 'Wilson', 'Affiliation': ""Orthopedics Institute, Children's Hospital Colorado, Aurora, Colorado.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Levek', 'Affiliation': 'Department of Pediatrics, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Ariel K', 'Initials': 'AK', 'LastName': 'Daoud', 'Affiliation': ""Orthopedics Institute, Children's Hospital Colorado, Aurora, Colorado.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Brewer', 'Affiliation': ""Orthopedics Institute, Children's Hospital Colorado, Aurora, Colorado.""}, {'ForeName': 'Katelyn', 'Initials': 'K', 'LastName': 'Brooks', 'Affiliation': ""Orthopedics Institute, Children's Hospital Colorado, Aurora, Colorado.""}, {'ForeName': 'Ada', 'Initials': 'A', 'LastName': 'Sochanska', 'Affiliation': ""Orthopedics Institute, Children's Hospital Colorado, Aurora, Colorado.""}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Randall', 'Affiliation': ""Orthopedics Institute, Children's Hospital Colorado, Aurora, Colorado.""}, {'ForeName': 'Aaron J', 'Initials': 'AJ', 'LastName': 'Provance', 'Affiliation': ""Orthopedics Institute, Children's Hospital Colorado, Aurora, Colorado.""}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002907'] 387,30325791,"Effects of Prolonging Eccentric Phase Duration in Parallel Back-Squat Training to Momentary Failure on Muscle Cross-Sectional Area, Squat One Repetition Maximum, and Performance Tests in University Soccer Players.","ABSTRACT Shibata, K, Takizawa, K, Nosaka, K, and Mizuno, M. Effects of prolonging eccentric phase duration in parallel back-squat training to momentary failure on muscle cross sectional area, squat one repetition maximum, and performance tests in university soccer players. J Strength Cond Res 35(3): 668-674, 2021-This study aimed to compare 2 squat training programs repeated until momentary failure with different eccentric phase duration (2 seconds vs. 4 seconds) on the changes in muscle cross-sectional area, squat 1 repetition maximum (1RM), squat jump (SJ), and countermovement jump (CMJ) height, agility (T-test), and Yo-Yo intermittent recovery test (YY-IR2). Male university soccer players (19.9 ± 0.9 years, 172.2 ± 3.8 cm, 66.1 ± 6.6 kg) were randomly assigned to one of the 2 groups; CON for 2 seconds and ECC for 4 seconds (C2/E4, n = 11) or CON for 2 seconds and ECC for 2 seconds (C2/E2, n = 11). They performed parallel back-squat exercises twice a week for 6 weeks using 75% 1RM weight to momentary failure in each set for 3 sets with each protocol. Outcome measurements were taken before (Pre) and after 3 (Mid; 1RM, SJ, and CMJ only), and at 6 weeks (Post). One repetition maximum increased more (p < 0.05) for C2/E2 (Pre: 95.9 ± 12.2 kg, Mid: 108.2 ± 15.4 kg, Post: 113.6 ± 14.8 kg) than C2/E4 (95.5 ± 12.9 kg, 102.7 ± 15.6 kg, 105.5 ± 14.9 kg, respectively). Cross-sectional area (50% of the thigh length: 3.5 ± 2.8%), SJ (6.7 ± 8.9%) and CMJ height (6.3 ± 8.6%) increased similarly between C2/E2 and C2/E4, but no significant changes in T-test or YY-IR2 were evident in either group. These results suggest that increasing the ECC phase duration during squat exercises does not produce greater training effects when compared with a shorter ECC phase-duration program with momentary failure.",2021,"One repetition maximum increased more (p < 0.05) for C2/E2 (Pre: 95.9 ± 12.2 kg, Mid: 108.2 ± 15.4 kg, Post: 113.6 ± 14.8 kg) than C2/E4 (95.5 ± 12.9 kg, 102.7 ± 15.6 kg, 105.5 ± 14.9 kg, respectively).","['university soccer players', 'Male university soccer players (19.9 ± 0.9 years, 172.2 ± 3.8 cm, 66.1 ± 6.6 kg', 'University Soccer Players']","['J Strength Cond Res XX(X', 'CON', 'squat training programs repeated until momentary failure with different eccentric phase duration', 'CON for 2 seconds and ECC']","['Shibata, K, Takizawa, K, Nosaka, K, and Mizuno, M. Effects', 'T-test or YY-IR2', 'changes in muscle cross-sectional area, squat 1 repetition maximum (1RM), squat jump (SJ), and countermovement jump (CMJ) height, agility (T-test), and Yo-Yo intermittent recovery test (YY-IR2', 'Muscle Cross-Sectional Area, Squat One Repetition Maximum, and Performance Tests', 'CMJ height']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517823', 'cui_str': '6.6 (qualifier value)'}]","[{'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C4077283', 'cui_str': '(67Ga)ECC'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4076913', 'cui_str': ""bis(2-(2'-benzothienyl)pyridinato-N,C3')iridium(III) (acetylacetonate)""}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}]",,0.0384999,"One repetition maximum increased more (p < 0.05) for C2/E2 (Pre: 95.9 ± 12.2 kg, Mid: 108.2 ± 15.4 kg, Post: 113.6 ± 14.8 kg) than C2/E4 (95.5 ± 12.9 kg, 102.7 ± 15.6 kg, 105.5 ± 14.9 kg, respectively).","[{'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Shibata', 'Affiliation': 'Strength and Conditioning Laboratory, Department of Sustainable Agriculture, College of Agriculture, Food and Environment Sciences, Rakuno Gakuen University, Ebetsu, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Takizawa', 'Affiliation': 'Institute of Physical Development Research, Sapporo, Japan.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Nosaka', 'Affiliation': 'School of Exercise and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia; and.'}, {'ForeName': 'Masao', 'Initials': 'M', 'LastName': 'Mizuno', 'Affiliation': 'Department of Human Developmental Sciences, Faculty of Education, Hokkaido University, Sapporo, Japan.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002838'] 388,30289873,Examination of Physical Fitness Parameters Between Professional and Amateur Greek Soccer Players During the Transition Period.,"ABSTRACT Bekris, E, Pidoulas, G, Pidoulas, P, Gissis, I, Katis, A, and Komsis, S. Examination of physical fitness parameters between professional and amateur Greek soccer players during the transition period. J Strength Cond Res 35(3): 776-781, 2021-The aim of the study was to compare physical fitness parameters between professional and amateur soccer players of different levels. The sample consisted of 381 soccer players divided in 4 experimental groups: first division professional players (n = 115), second division professional players (n = 70), third division semiprofessional players (n = 93), and amateur soccer players (n = 103). Players were tested for several physiological parameters at the end of the transition period. Analysis of variance showed significantly lower body fat and increased maximum oxygen consumption (V̇o2max) and velocity of maximum oxygen consumption (vV̇o2max) values for first division professional players compared with the other experimental groups (p < 0.05). Similarly, first division professional players showed higher performance during squat jump and countermovement jump test compared with the other experimental groups (p < 0.05). Significant differences on flexibility test were observed between amateur players and the other group (p < 0.05). The results of the study indicated that Greek soccer players at the highest level overcome in almost all the underexamination physiological parameters probably because of less absence from training and better implementation of training programs during the transition period.",2021,Significant differences on flexibility test were observed between amateur players and the other group (p < 0.05).,"['first division professional players', 'professional and amateur soccer players of different levels', '381 soccer players divided in 4 experimental groups: first division professional players (n = 115), second division professional players (n = 70), third division semiprofessional players (n = 93), and amateur soccer players (n = 103']","['J Strength Cond Res XX(X', 'V[Combining']","['Dot Above]O2max) and velocity of maximum oxygen consumption (vV[Combining Dot Above]O2max) values', 'maximum oxygen consumption', 'flexibility test', 'higher performance during squat jump and countermovement jump test', 'Bekris, E, Pidoulas, G, Pidoulas, P, Gissis, I, Katis, A, and Komsis, S. Examination of physical fitness parameters']","[{'cui': 'C1293097', 'cui_str': 'Division - action (qualifier value)'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4708787', 'cui_str': '381 (qualifier value)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}]",[],"[{'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0202038,Significant differences on flexibility test were observed between amateur players and the other group (p < 0.05).,"[{'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Bekris', 'Affiliation': 'Department of Physical Education and Sport Science, National and Kapodistrian University of Athens, Athens, Greece; and.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Pidoulas', 'Affiliation': 'Department of Physical Education and Sport Science, National and Kapodistrian University of Athens, Athens, Greece; and.'}, {'ForeName': 'Pantelis', 'Initials': 'P', 'LastName': 'Pidoulas', 'Affiliation': 'Department of Physical Education and Sport Science, National and Kapodistrian University of Athens, Athens, Greece; and.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Gissis', 'Affiliation': 'Neuromechanics Laboratory, Department of Physical Education and Sport Science, Serres, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Katis', 'Affiliation': 'Neuromechanics Laboratory, Department of Physical Education and Sport Science, Serres, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Stergios', 'Initials': 'S', 'LastName': 'Komsis', 'Affiliation': 'Neuromechanics Laboratory, Department of Physical Education and Sport Science, Serres, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002770'] 389,30363038,Progressive Workload Periodization Maximizes Effects of Nordic Hamstring Exercise on Muscle Injury Risk Factors.,"ABSTRACT Severo-Silveira, L, Dornelles, MP, Lima-e-Silva, FX, Marchiori, CL, Medeiros, TM, Pappas, E, and Baroni, BM. Progressive workload periodization maximizes effects of Nordic hamstring exercise on muscle injury risk factors. J Strength Cond Res 35(4): 1006-1013, 2021-This study aimed to investigate the effect of 2 different Nordic hamstring exercise (NHE) training programs (constant workload vs. progressive workload) on multiple risk factors for hamstring strain injury in high competitive level athletes. Twenty-one premier league rugby union players (∼26 years) were randomized into 1 of 2 experimental groups and completed an 8-week NHE training program: constant training group (CTG) or progressive training group (PTG). Knee flexor/extensor strength and biceps femoris long head (BFLH) muscle architecture were assessed through isokinetic dynamometry and ultrasonography, respectively, before and after the training programs. Increased hamstring concentric (Δ = 8%, p = 0.004, d = 0.42) and eccentric (Δ = 7%, p = 0.041, d = 0.39) peak torques, as well as H:Q conventional (Δ = 7%, p = 0.015, d = 0.54) and functional (Δ = 6%, p = 0.026, d = 0.62) ratios were observed in the follow-up compared with baseline for the PTG group only. Nordic hamstring exercise training significantly increased BFLH muscle thickness (CTG: Δ = 7%, p = 0.001, d = 0.60; PTG: Δ = 7%, p < 0.001, d = 0.54) and fascicle length (CTG: Δ = 8%, p < 0.001, d = 0.29; PTG: Δ = 10%, p < 0.001, d = 0.35) in both groups. Training adaptations on hamstring peak torque (concentric and eccentric) and H:Q ratio (conventional and functional) ""likely favor"" PTG, whereas changes in BFLH fascicle length ""possibly favor"" PTG. In conclusion, only PTG enhanced hamstring strength; both NHE training programs increased BFLH muscle thickness and fascicle length, but progressive training generated greater changes on fascicle length than constant training. Medical/coaching staff should be aware that NHE with adequate training periodization with workload progression to maximize its benefits.",2021,"Increased hamstring concentric (Δ = 8%, p = 0.004, d = 0.42) and eccentric (Δ = 7%, p = 0.041, d = 0.39) peak torques, as well as H:Q conventional (Δ = 7%, p = 0.015, d = 0.54) and functional (Δ = 6%, p = 0.026, d = 0.62) ratios were observed in the follow-up compared with baseline for the PTG group only.","['hamstring strain injury in high competitive level athletes', 'Twenty-one premier league rugby union players (∼26 years']","['Knee flexor/extensor strength and biceps femoris long head ', 'Nordic hamstring exercise', 'NHE training program: constant training group (CTG) or progressive training group (PTG', 'J Strength Cond Res XX(X', 'Nordic hamstring exercise (NHE) training programs (constant workload vs. progressive workload', 'Nordic hamstring exercise training', 'Nordic Hamstring Exercise']","['Increased hamstring concentric', 'BFLH muscle thickness and fascicle length', 'fascicle length', 'Muscle Injury Risk Factors', 'peak torques', 'Severo-Silveira, L, Dornelles, MP, Lima-e-Silva, FX, Marchiori, CL, Medeiros, TM, Pappas, E, and Baroni, BM', 'muscle injury risk factors', 'BFLH muscle thickness', 'hamstring peak torque (concentric and eccentric) and H:Q ratio (conventional and functional']","[{'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}]","[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0439744', 'cui_str': 'Concentric (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0410256', 'cui_str': 'Injury of muscle (disorder)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",,0.0133278,"Increased hamstring concentric (Δ = 8%, p = 0.004, d = 0.42) and eccentric (Δ = 7%, p = 0.041, d = 0.39) peak torques, as well as H:Q conventional (Δ = 7%, p = 0.015, d = 0.54) and functional (Δ = 6%, p = 0.026, d = 0.62) ratios were observed in the follow-up compared with baseline for the PTG group only.","[{'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Severo-Silveira', 'Affiliation': 'Federal University of Health Sciences of Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil; and.'}, {'ForeName': 'Maurício P', 'Initials': 'MP', 'LastName': 'Dornelles', 'Affiliation': 'Federal University of Health Sciences of Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil; and.'}, {'ForeName': 'Felipe X', 'Initials': 'FX', 'LastName': 'Lima-E-Silva', 'Affiliation': 'Federal University of Health Sciences of Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil; and.'}, {'ForeName': 'César L', 'Initials': 'CL', 'LastName': 'Marchiori', 'Affiliation': 'Federal University of Health Sciences of Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil; and.'}, {'ForeName': 'Thales M', 'Initials': 'TM', 'LastName': 'Medeiros', 'Affiliation': 'Federal University of Health Sciences of Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil; and.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Pappas', 'Affiliation': 'University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Bruno M', 'Initials': 'BM', 'LastName': 'Baroni', 'Affiliation': 'Federal University of Health Sciences of Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil; and.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002849'] 390,30200193,"Favorable Effects of a Ketogenic Diet on Physical Function, Perceived Energy, and Food Cravings in Women with Ovarian or Endometrial Cancer: A Randomized, Controlled Trial.","Ketogenic diets (KDs) are gaining attention as a potential adjuvant therapy for cancer, but data are limited for KDs' effects on quality of life. We hypothesized that the KD would (1) improve mental and physical function, including energy levels, (2) reduce hunger, and (3) diminish sweet and starchy food cravings in women with ovarian or endometrial cancer. Participants were randomized to a KD (70:25:5 energy from fat, protein, and carbohydrate) or the American Cancer Society diet (ACS: high-fiber, lower-fat). Questionnaires were administered at baseline and after 12 weeks on the assigned diet to assess changes in mental and physical health, perceived energy, appetite, and food cravings. We assessed both between-group differences and within-group changes using ANCOVA and paired t -tests, respectively. After 12 weeks, there was a significant between-group difference in adjusted physical function scores ( p < 0.05), and KD participants not receiving chemotherapy reported a significant within-group reduction in fatigue ( p < 0.05). There were no significant between-group differences in mental function, hunger, or appetite. There was a significant between-group difference in adjusted cravings for starchy foods and fast food fats at 12 weeks ( p < 0.05 for both), with the KD group demonstrating less frequent cravings than the ACS. In conclusion, in women with ovarian or endometrial cancer, a KD does not negatively affect quality of life and in fact may improve physical function, increase energy, and diminish specific food cravings. This trial was registered at ClinicalTrials.gov as NCT03171506.",2018,"After 12 weeks, there was a significant between-group difference in adjusted physical function scores ( p < 0.05), and KD participants not receiving chemotherapy reported a significant within-group reduction in fatigue ( p < 0.05).","['women with ovarian or endometrial cancer', 'Women with Ovarian or Endometrial Cancer']","['Ketogenic Diet', 'Ketogenic diets (KDs', 'KD (70:25:5 energy from fat, protein, and carbohydrate) or the American Cancer Society diet (ACS: high-fiber, lower-fat']","['mental function, hunger, or appetite', 'Physical Function, Perceived Energy, and Food Cravings', 'fatigue', 'changes in mental and physical health, perceived energy, appetite, and food cravings', 'adjusted cravings for starchy foods and fast food fats', 'frequent cravings', 'adjusted physical function scores', 'mental and physical function, including energy levels, (2) reduce hunger, and (3) diminish sweet and starchy food cravings']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}]","[{'cui': 'C0259972', 'cui_str': 'Ketogenic Diet'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0002455', 'cui_str': 'American Cancer Society'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0563143', 'cui_str': 'Mental function'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0872380', 'cui_str': 'Food craving'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0452492', 'cui_str': 'Starchy food (substance)'}, {'cui': 'C0344355', 'cui_str': 'Convenience Foods'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205216', 'cui_str': 'Decreased (qualifier value)'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}]",,0.137463,"After 12 weeks, there was a significant between-group difference in adjusted physical function scores ( p < 0.05), and KD participants not receiving chemotherapy reported a significant within-group reduction in fatigue ( p < 0.05).","[{'ForeName': 'Caroline W', 'Initials': 'CW', 'LastName': 'Cohen', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL 35294, USA. cwyoder@uab.edu.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Fontaine', 'Affiliation': 'Department of Health Behavior, University of Alabama at Birmingham, Birmingham, AL 35294, USA. kfontai1@uab.edu.'}, {'ForeName': 'Rebecca C', 'Initials': 'RC', 'LastName': 'Arend', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL 35294, USA. rarend@uabmc.edu.'}, {'ForeName': 'Taraneh', 'Initials': 'T', 'LastName': 'Soleymani', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL 35294, USA. tsoleymani@hotmail.com.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Gower', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL 35294, USA. bgower@uab.edu.'}]",Nutrients,['10.3390/nu10091187'] 391,31677181,Effect of clomiphene citrate treatment on the Sertoli cells of dysmetabolic obese men with low testosterone levels.,"BACKGROUND Clomiphene citrate (CC) has been shown to restore the hypothalamic-pituitary-gonadal (HPG) axis by increasing testosterone (T) levels to physiological levels in patients with dysmetabolic conditions such as obesity, metabolic syndrome and type 2 diabetes mellitus (T2DM). However, the data are unclear regarding the effects on Sertoli cell (SC) function. AIM To study SC function by assessing Inhibin B (IB) and anti-Mullerian hormone (AMH) levels at baseline and after 3 months of CC treatment. MATERIALS AND METHODS This is an ancillary study of a cross-over, randomised, double-blind, placebo-controlled trial performed to evaluate androgen response to CC treatment in dysmetabolic obese subjects with low T levels treated with metformin. We evaluated SC function by assessing IB and AMH levels at baseline and after 3 months of each treatment in ten dysmetabolic obese subjects with low T levels. In all subjects, the influence of the clinical characteristics, metabolic and hormonal baseline parameters on SC and Leydig (LC) function, evaluated respectively with AMH, IB, follicle-stimulating hormone (FSH) and T levels, was tested. RESULTS No significant changes were observed for IB and AMH concentrations after each treatment period. Whereas T and oestradiol (E2) levels were shown to be significantly higher in the CC plus metformin phase (CC/Met) only. No clinical, metabolic or hormonal parameters showed significant effects on serum AMH at baseline or after treatments. However, baseline T, dihydrotestosterone (DHT) and E2 positively affected IB levels during CC/Met therapy (P = .003, P = .038 and P = .049, respectively). Baseline leptin and FSH had a negative (P = 031) and positive (P = .048) respectively role on T levels during CC/Met, as they were statistically significant compared to the placebo period (Plac/Met). CONCLUSION Unlike the LC activity, CC was unable to influence SC function, as shown by the lack of IB and AMH serum modifications, thus suggesting an intrinsic nonreversible defect of SC cells in patients with dysmetabolic conditions.",2020,"No clinical, metabolic or hormonal parameters showed significant effects on serum AMH at baseline or after treatments.","['Sertoli cellsof dysmetabolic obese men with low testosterone levels', 'dysmetabolic obese subjects with low T levels treated with', 'patients with dysmetabolic conditions such as obesity, metabolic syndrome and type 2 diabetes mellitus (T2DM', 'ten dysmetabolic obese subjects with low T levels', 'patients with dysmetabolic conditions']","['Clomiphene citrate (CC', 'clomiphene citrate treatment', 'metformin', 'placebo']","['serum AMH', 'IB and AMH levels', 'T levels', 'T and estradiol (E2) levels', 'Baseline leptin, and FSH', 'IB and AMH concentrations', 'LC activity', 'baseline T, dihydrotestosterone (DHT) andE2 positively affected IB levels', 'Inhibin B (IB) and Anti-Mullerian Hormone (AMH) levels', 'clinical characteristics, metabolic and hormonal baseline parameters on SC and Leydig (LC) function, evaluated respectively with AMH, IB, FSH and T levels']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1295654', 'cui_str': 'Decreased testosterone level'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C0546859', 'cui_str': 'Clomiphene Citrate'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0038148', 'cui_str': 'Dihydrotestosterone'}, {'cui': 'C0971174', 'cui_str': 'inhibin B'}, {'cui': 'C4048548', 'cui_str': 'Anti-Mullerian hormone level'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.0632596,"No clinical, metabolic or hormonal parameters showed significant effects on serum AMH at baseline or after treatments.","[{'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Pelusi', 'Affiliation': 'Endocrinology Unit and Center for Applied Biomedical Research, Department of Medical & Surgical Sciences (DIMEC), Alma Mater Studiorum University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Flaminia', 'Initials': 'F', 'LastName': 'Fanelli', 'Affiliation': 'Endocrinology Unit and Center for Applied Biomedical Research, Department of Medical & Surgical Sciences (DIMEC), Alma Mater Studiorum University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Baccini', 'Affiliation': 'Endocrinology Unit and Center for Applied Biomedical Research, Department of Medical & Surgical Sciences (DIMEC), Alma Mater Studiorum University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Triggiani', 'Affiliation': 'Interdisciplinary Department of Medicine, Internal Medicine, Geriatrics, Endocrinology and Rare Diseases, University of Bari, Bari, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Bartolomeo', 'Affiliation': 'Department of Biomedical Science and Human Oncology, University of Bari, Bari, Italy.'}, {'ForeName': 'Matteo Domenico', 'Initials': 'MD', 'LastName': 'Carbone', 'Affiliation': 'Institute of Clinical and Hormonal Research, Foggia, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'De Pergola', 'Affiliation': 'Nutrition Outpatient Clinic, Clinical Oncology Unit, University of Bari, Bari, Italy.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Di Dalmazi', 'Affiliation': 'Endocrinology Unit and Center for Applied Biomedical Research, Department of Medical & Surgical Sciences (DIMEC), Alma Mater Studiorum University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Uberto', 'Initials': 'U', 'LastName': 'Pagotto', 'Affiliation': 'Endocrinology Unit and Center for Applied Biomedical Research, Department of Medical & Surgical Sciences (DIMEC), Alma Mater Studiorum University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Pasquali', 'Affiliation': 'Endocrinology Unit and Center for Applied Biomedical Research, Department of Medical & Surgical Sciences (DIMEC), Alma Mater Studiorum University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Vito Angelo', 'Initials': 'VA', 'LastName': 'Giagulli', 'Affiliation': 'Outpatients Clinic of Endocrinology and Metabolic Disease, Conversano Hospital, Bari, Italy.'}]",Clinical endocrinology,['10.1111/cen.14122'] 392,29589111,Effects of resistance training on MRI-derived epicardial fat volume and arterial stiffness in women with obesity: a randomized pilot study.,"AIM To date, few studies have analyzed the effects of exercise on cardiac adipose tissue. Overall, exercise programs did not meet the recommendations for significant weight loss, the utilization of resistance training was minimal, and the conclusions derived from these studies have diminished exercise as a strategy for cardiac fat loss. PURPOSE The objective of this pilot study was to analyze the effects of 3-week high-intensity, moderate-volume muscular endurance resistance training (RT) on cardiac fat and arterial stiffness. METHODS A total of 11 young females with obesity, BMI = 34.13 (± 3.16) kg/m 2 (n = 5 control, n = 6 intervention) completed the study. Absolute strength was assessed using one repetition maximum test (1RM) for bench press (BP) and leg press (LP), and relative strength was calculated using body weight (BW) as BP-to-BW and LP-to-BW ratio. Magnetic resonance was used to quantify epicardial and paracardial adipose tissue (EAT and PAT) volume, and applanation tonometry was used to assess arterial stiffness by estimating pulse wave velocity (PWV). RESULTS EAT and PAT volumes (ml) showed significant interaction effects (p = 0.037 and p = 0.031), and very large changes (d > 1) of EAT (p = 0.006) and PAT (p = 0.036) in the intervention group. In addition, strength was significantly improved, including BP (p = 0.003), LP (p = 0.001), BP-to-BW ratio (p = 0.001), and LP-to-BW ratio (p = 0.002), while no changes were found in PWV. CONCLUSIONS High-intensity, moderate-volume RT, designed to enhance muscular endurance following the recommendations reduces EAT and PAT volumes, improves physical fitness in females with obesity, and has no negative effects on arterial stiffness.",2018,"RESULTS EAT and PAT volumes (ml) showed significant interaction effects (p = 0.037 and p = 0.031), and very large changes (d > 1) of EAT (p = 0.006) and PAT (p = 0.036) in the intervention group.","['females with obesity', '11 young females with obesity, BMI\u2009=\u200934.13 (±\u20093.16) kg/m 2 (n\u2009=\u20095 control, n\u2009=\u20096 intervention) completed the study', 'women with obesity']","['resistance training', '3-week high-intensity, moderate-volume muscular endurance resistance training (RT', 'Magnetic resonance']","['cardiac fat and arterial stiffness', 'physical fitness', 'Absolute strength', 'interaction effects', 'repetition maximum test (1RM) for bench press (BP) and leg press (LP), and relative strength', 'BP', 'epicardial and paracardial adipose tissue (EAT and PAT) volume, and applanation tonometry', 'LP', 'BP-to-BW ratio']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}]","[{'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0454326', 'cui_str': 'Bench press (regime/therapy)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0442016', 'cui_str': 'Epicardial (qualifier value)'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0030587', 'cui_str': 'Paroxysmal atrial tachycardia (disorder)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0430862', 'cui_str': 'Applanation tonometry (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",11.0,0.0316204,"RESULTS EAT and PAT volumes (ml) showed significant interaction effects (p = 0.037 and p = 0.031), and very large changes (d > 1) of EAT (p = 0.006) and PAT (p = 0.036) in the intervention group.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Fernandez-del-Valle', 'Affiliation': 'Department of Applied Health, Southern Illinois University Edwardsville, Vadalabene Center, Edwardsville, IL, 62026, USA. marfern@siue.edu.'}, {'ForeName': 'Joaquin U', 'Initials': 'JU', 'LastName': 'Gonzales', 'Affiliation': 'Department of Kinesiology and Sport Management, Texas Tech University, 3204 Main St, Lubbock, TX, 79409, USA.'}, {'ForeName': 'Shelby', 'Initials': 'S', 'LastName': 'Kloiber', 'Affiliation': 'Department of Kinesiology and Sport Management, Texas Tech University, 3204 Main St, Lubbock, TX, 79409, USA.'}, {'ForeName': 'Sunanda', 'Initials': 'S', 'LastName': 'Mitra', 'Affiliation': 'Department of Electrical and Computer Engineering, Texas Tech University, 1012 Boston Ave, Lubbock, TX, 79409, USA.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Klingensmith', 'Affiliation': 'Department of Electrical and Computer Engineering, Southern Illinois University Edwardsville, 30 Circle Drive, Edwardsville, IL, 62026, USA.'}, {'ForeName': 'Eneko', 'Initials': 'E', 'LastName': 'Larumbe-Zabala', 'Affiliation': 'Clinical Research Institute, Texas Tech University Health Sciences Center, 3601 4th Street, Lubbock, TX, 79430, USA.'}]",European journal of applied physiology,['10.1007/s00421-018-3852-9'] 393,30040009,"Effects of Kinesio Taping on the Relief of Delayed Onset Muscle Soreness: A Randomized, Placebo-Controlled Trial.","OBJECTIVE The purpose of this study was to examine the effects of Kinesio taping (KT) on delayed onset muscle soreness. DESIGN Randomized controlled study. SETTING Clinical laboratory. PARTICIPANTS Fifty-four nonathletic volunteers were assigned randomly to KT (n = 27) and placebo KT (n = 27) groups. INTERVENTIONS The intense exercise protocol consisted of 100 consecutive drop jumps from a 0.60-m-high platform. Kinesio tape was applied with the fan technique on the quadriceps muscles in the KT group. The placebo KT group received the Kinesio tape with no technique and tension. MAIN OUTCOME MEASURE Muscle soreness, maximal isometric quadriceps muscle strength, vertical jump height, and blood analyses (creatine kinase, lactate dehydrogenase, myoglobin, and C-reactive protein) were measured preexercise, immediately postexercise, 48 hours postexercise, and 72 hours postexercise. RESULTS There was a significant effect of time in all outcome measures (P < .05) except serum C-reactive protein level (P > .05). The intensity of muscle soreness was significantly lower in the KT group relative to the placebo KT group at 72 hours postexercise (P = .01). The serum creatine kinase level was significantly higher in the KT group compared with the placebo KT group at 72 hours postexercise (P = .01). There were no statistically significant differences between groups for the other outcome measures (P > .05). CONCLUSIONS These findings indicate that KT intervention following the intense exercise protocol reduced muscle soreness. However, it had no effect on maximal quadriceps isometric strength and vertical jump height or serum lactate dehydrogenase, myoglobin, and C-reactive protein levels. Furthermore, KT application after intense exercise also increased serum creatine kinase levels.",2019,There was a significant effect of time in all outcome measures (P < .05) except serum C-reactive protein level (P > .05).,['Fifty-four nonathletic volunteers'],"['Placebo', 'Kinesio tape', 'placebo KT', 'KT', 'KT intervention', 'Kinesio tape with no technique and tension', 'Kinesio taping (KT', 'Kinesio Taping']","['serum C-reactive protein level', 'serum creatine kinase level', 'maximal quadriceps isometric strength and vertical jump height or serum lactate dehydrogenase, myoglobin, and C-reactive protein levels', 'serum creatine kinase levels', 'Muscle soreness, maximal isometric quadriceps muscle strength, vertical jump height, and blood analyses (creatine kinase, lactate dehydrogenase, myoglobin, and C-reactive protein', 'intensity of muscle soreness', 'muscle soreness', 'Relief of Delayed Onset Muscle Soreness']","[{'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0233494', 'cui_str': 'Tension (finding)'}]","[{'cui': 'C1277266', 'cui_str': 'Serum C reactive protein level'}, {'cui': 'C1275731', 'cui_str': 'Serum creatine kinase level'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C1278052', 'cui_str': 'Serum lactate dehydrogenase measurement'}, {'cui': 'C0027078', 'cui_str': 'Myoglobin'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0005768'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C0022917', 'cui_str': 'L-Lactate Dehydrogenase'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}]",54.0,0.123835,There was a significant effect of time in all outcome measures (P < .05) except serum C-reactive protein level (P > .05).,"[{'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Hazar Kanik', 'Affiliation': ''}, {'ForeName': 'Seyit', 'Initials': 'S', 'LastName': 'Citaker', 'Affiliation': ''}, {'ForeName': 'Canan', 'Initials': 'C', 'LastName': 'Yilmaz Demirtas', 'Affiliation': ''}, {'ForeName': 'Neslihan', 'Initials': 'N', 'LastName': 'Celik Bukan', 'Affiliation': ''}, {'ForeName': 'Bulent', 'Initials': 'B', 'LastName': 'Celik', 'Affiliation': ''}, {'ForeName': 'Gurkan', 'Initials': 'G', 'LastName': 'Gunaydin', 'Affiliation': ''}]",Journal of sport rehabilitation,['10.1123/jsr.2018-0040'] 394,29939900,High-Intensity Interval vs. Continuous Endurance Training: Preventive Effects on Hormonal Changes and Physiological Adaptations in Prediabetes Patients.,"ABSTRACT Safarimosavi, S, Mohebbi, H, and Rohani, H. High-intensity interval vs. continuous endurance training: Preventive effects on hormonal changes and physiological adaptations in prediabetes patients. J Strength Cond Res 35(3): 731-738, 2021-The aim of this study was to examine the effects of a 12-week high-intensity interval training (HIIT) intervention, or an isocaloric continuous endurance training (CET) intervention on insulin resistance indices and change in irisin and preptin in patients with prediabetes. Thirty-two prediabetic male patients (age = 38.7 ± 4; body mass index = 26.9 ± 1.4 kg·m-2; and V̇o2peak = 2.49 ± 0.22 L·min-1) were randomly assigned into 3 training groups (N = 8). These groups were matched based on the required energy expenditure (EE) for completing each protocol: (a) HIIT (10 × 60 seconds at 90% peak oxygen uptake [V̇o2peak], 1: 1 work to recovery at 50 W), (b) CET at an intensity equivalent to maximal fat oxidation (Fatmax) (CETFAT) (pedaling for a duration that expends an equivalent EE to an HIIT session [E ≈ HIIT]), (c) CET at an intensity equivalent to anaerobic threshold (CETAT) (E ≈ HIIT), and (d) the control group (CON): continued to perform their daily activities. After intervention, blood glucose levels were significantly (p < 0.05) lower in the HIIT group compared with CETAT group. Exercise training improved the insulin resistance index by 35, 28, and 37% in CETFAT, CETAT, and HIIT groups, respectively. Irisin concentrations in the HIIT and CETAT groups was significantly (p < 0.05) decreased compared with the pre-training values. Also, HIIT and CETFAT resulted in significant (p < 0.05) changes in preptin concentration compared with baseline. This study demonstrated that both HIIT and CETFAT protocols had similar effects on the insulin resistance index of prediabetic patients. Also, the intensity and type of exercise were effective factors in changing irisin and preptin concentrations.",2021,Irisin concentrations in the HIIT and CETAT groups was significantly (p < 0.05) decreased compared with the pre-training values.,"['patients with prediabetes', 'Thirty-two prediabetic male patients (age = 38.7 ± 4; body mass index = 26.9 ± 1.4 kg·m; and V[Combining Dot Above]O2peak = 2.49 ± 0.22 L·min', 'prediabetic patients', 'Prediabetes Patients', 'prediabetes patients']","['High-Intensity Interval vs. Continuous Endurance Training', 'V[Combining', 'J Strength Cond Res XX(X', 'anaerobic threshold (CETAT', 'HIIT and CETFAT', 'Exercise training', 'Dot Above]O2peak', 'isocaloric continuous endurance training (CET) intervention', 'high-intensity interval training (HIIT) intervention']","['Hormonal Changes and Physiological Adaptations', 'preptin concentration', 'insulin resistance indices and change in irisin and preptin', 'Irisin concentrations', 'Safarimosavi, S, Mohebbi, H, and Rohani, H. High-intensity interval', 'blood glucose levels', 'insulin resistance index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C4708661', 'cui_str': '2.49'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}]","[{'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0001400', 'cui_str': 'Adaptations, Physiologic'}, {'cui': 'C1100366', 'cui_str': 'proinsulin-like growth factor II E-peptide (69-102)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}]",32.0,0.0278581,Irisin concentrations in the HIIT and CETAT groups was significantly (p < 0.05) decreased compared with the pre-training values.,"[{'ForeName': 'Saleh', 'Initials': 'S', 'LastName': 'Safarimosavi', 'Affiliation': 'Faculty of Physical Education and Sport Sciences, Department of Exercise Physiology, University of Guilan, Rasht, Iran; and.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Mohebbi', 'Affiliation': 'Faculty of Physical Education and Sport Sciences, Department of Exercise Physiology, University of Guilan, Rasht, Iran; and.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Rohani', 'Affiliation': 'Department of Exercise Physiology, Sport Sciences Research Institute, Tehran, Iran.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002709'] 395,30024484,Prior Knowledge of the Grading Criteria Increases Functional Movement Screen Scores in Youth Soccer Players.,"ABSTRACT Bryson, A, Arthur, R, and Easton, C. Prior knowledge of the grading criteria increases Functional Movement Screen scores in youth soccer players. J Strength Cond Res 35(3): 762-768, 2021-We sought to determine whether familiarity with the grading criteria of the Functional Movement Screen (FMS) impacted the outcome score in elite youth soccer players. Thirty-two trained male youth soccer players (aged 17 ± 1 years) participated in a randomized control trial. Subjects were randomly assigned to evenly sized control and experimental groups, who each completed the FMS on 2 separate occasions. Subjects in the experimental group were provided the FMS grading criteria between their first and second screens. Time-synchronized video footage was used to grade the FMS using standardized criteria. Structured interviews were then conducted with selected subjects (n = 4) in the experimental group to establish athletes' perception of the FMS. The experimental group had a large increase in overall FMS score from the first to the second screen in comparison with the control group (Δ2.0 ± 1.0, p < 0.001, d = 1.3). Scores for the deep squat, hurdle step, and rotary stability tests components of the FMS all increased in the experimental group in comparison with the control group (p < 0.05). Thematic analysis of the interview data suggested that the subjects in the experimental group improved their understanding between good and poor technique during the FMS. These findings support the notion that FMS scores are influenced by awareness of the grading criteria. As a consequence, the FMS may not be suitable for objectively predicting injury in youth soccer players.",2021,"Scores for the deep squat, hurdle step, and rotary stability tests components of the FMS all increased in the experimental group in comparison with the control group (p < 0.05).","['youth soccer players', 'Youth Soccer Players', 'elite youth soccer players', 'Thirty-two trained male youth soccer players (aged 17 ± 1 years']","['J Strength Cond Res XX(X', 'Functional Movement Screen (FMS']","['overall FMS score', 'Functional Movement Screen scores', 'deep squat, hurdle step, and rotary stability tests components of the FMS']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]",32.0,0.0176392,"Scores for the deep squat, hurdle step, and rotary stability tests components of the FMS all increased in the experimental group in comparison with the control group (p < 0.05).","[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Bryson', 'Affiliation': 'Institute for Clinical Exercise and Health Science, University of the West of Scotland, Hamilton, United Kingdom; and.'}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Arthur', 'Affiliation': 'Institute for Clinical Exercise and Health Science, University of the West of Scotland, Hamilton, United Kingdom; and.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Easton', 'Affiliation': 'Institute for Clinical Exercise and Health Science, University of the West of Scotland, Hamilton, United Kingdom; and.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002724'] 396,31642953,"Randomized, controlled trial of fesoterodine fumarate for overactive bladder in Parkinson's disease.","AIMS To evaluate short-term efficacy and safety of fesoterodine fumarate in Parkinson's disease (PD) patients with overactive bladder (OAB) symptoms. METHODS This is a randomized, double-blind, placebo-controlled study. It also has an open-label extension phase. From May 2016 to May 2018, 63 patients were randomized to receive fesoterodine 4 mg or placebo for 4 weeks. At the end of 4 weeks of randomization phase, patients were received fesoterodine fumarate 4 mg daily for another 4 weeks at the open-label extension phase. The change in the mean number of micturition episodes per 24 h period was the primary outcome measure of the study. RESULTS The number of micturition episodes per 24 h period significantly improved with the use of fesoterodine fumarate in the double-blind phase (p < 0.001). Also the mean number of nocturia and urgency episodes decreased in the fesoterodine group. In the open-label phase, the mean number of micturition, urgency and urgency urinary incontinence episodes were improved significantly. The number of nocturia episodes did not change in the open-label phase. Cognitive functions were stable after 4 weeks of fesoterodine 4 mg treatment. CONCLUSIONS OAB symptoms were significantly improved in older adults with PD under fesoterodine fumarate treatment, and this advantage continued in the open-label portion in the short term. In this randomized controlled study, the cognitive functions of the participants were not affected by fesoterodine 4 mg treatment compared with placebo.",2020,The number of micturition episodes per 24 h period significantly improved with the use of fesoterodine fumarate in the double-blind phase (p < 0.001).,"[""Parkinson's disease (PD) patients with overactive bladder (OAB) symptoms"", 'From May 2016 to May 2018, 63 patients', 'older adults with PD under', ""overactive bladder in Parkinson's disease""]","['placebo', 'fesoterodine', 'fesoterodine 4\xa0mg or placebo', 'fesoterodine fumarate']","['Cognitive functions', 'mean number of nocturia and urgency episodes', 'mean number of micturition episodes', 'number of nocturia episodes', 'number of micturition episodes', 'OAB symptoms', 'mean number of micturition, urgency and urgency urinary incontinence episodes']","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2343853', 'cui_str': 'fesoterodine'}, {'cui': 'C2343854', 'cui_str': 'Fesoterodine Fumarate'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0028734', 'cui_str': 'Nycturia'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}]",63.0,0.284208,The number of micturition episodes per 24 h period significantly improved with the use of fesoterodine fumarate in the double-blind phase (p < 0.001).,"[{'ForeName': 'Tarik', 'Initials': 'T', 'LastName': 'Yonguc', 'Affiliation': 'Department of Urology, Health Sciences University, Bozyaka Training and Research Hospital, Izmir, Turkey. tyonguc@gmail.com.'}, {'ForeName': 'Ertugrul', 'Initials': 'E', 'LastName': 'Sefik', 'Affiliation': 'Department of Urology, Health Sciences University, Bozyaka Training and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Ipek', 'Initials': 'I', 'LastName': 'Inci', 'Affiliation': 'Department of Neurology, Health Sciences University, Bozyaka Training and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Ozge Yılmaz', 'Initials': 'OY', 'LastName': 'Kusbeci', 'Affiliation': 'Department of Neurology, Health Sciences University, Bozyaka Training and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Serdar', 'Initials': 'S', 'LastName': 'Celik', 'Affiliation': 'Department of Urology, Health Sciences University, Bozyaka Training and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Mehmet Erhan', 'Initials': 'ME', 'LastName': 'Aydın', 'Affiliation': 'Department of Urology, Health Sciences University, Bozyaka Training and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Salih', 'Initials': 'S', 'LastName': 'Polat', 'Affiliation': 'Department of Urology, Amasya University Sabuncuoglu Serefeddin Training and Research Hospital, Amasya, Turkey.'}]",World journal of urology,['10.1007/s00345-019-02981-7'] 397,29781935,Balance Training Reduces Postural Sway and Improves Sport-specific Performance in Visually Impaired Cross-Country Skiers.,"ABSTRACT Kurz, A, Lauber, B, Franke, S, and Leukel, C. Balance training reduces postural sway and improves sport-specific performance in visually impaired cross-country skiers. J Strength Cond Res 35(1): 247-252, 2021-Balance training is highly effective in reducing sport injuries and causes improvements in postural stability and rapid force production. So far, the positive effects of balance training have been described for healthy athletes. In the present experiments, we questioned whether athletes with disabilities of the visual system can also benefit from balance training. Fourteen visually impaired cross-country skiers participated in this randomized controlled study. The intervention group (N = 7) completed 8 sessions of balance training over a period of 4 weeks (2 times per week), whereas a waiting control group (N = 7) received no training during that time. After training, postural sway was significantly reduced in the intervention group but not in the waiting control group. In addition, sport-specific performance, which was assessed by a standardized Cooper's 12-minute test on roller skis or rollerblades, increased in the intervention group. The change in postural sway from the premeasurement to the postmeasurement correlated with the change in sport-specific performance in all subjects. Our results indicate that balance training is useful for improving postural stability and sport-specific performance in visually impaired cross-country skiers. We propose that balance training should therefore be implemented as part of the training routine in athletes with disabilities of the visual system.",2021,Our results indicate that balance training is useful for improving postural stability and sport-specific performance in visually impaired cross-country skiers.,"['healthy athletes', 'athletes with disabilities of the visual system', 'Fourteen visually impaired cross-country skiers', 'Visually Impaired Cross-Country Skiers']","['J Strength Cond Res XX(X', 'balance training', 'Balance Training', 'no training during that time']","['postural stability and sport-specific performance', 'Postural Sway and Improves Sport-specific Performance', 'postural sway', 'postural stability and rapid force production', 'postural sway and improves sport-specific performance']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0425040', 'cui_str': 'Skier (finding)'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0033268'}]",14.0,0.0321626,Our results indicate that balance training is useful for improving postural stability and sport-specific performance in visually impaired cross-country skiers.,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kurz', 'Affiliation': 'Department of Sport Science, University of Freiburg, Breisgau, Germany.'}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Lauber', 'Affiliation': 'Department of Sport Science, University of Freiburg, Breisgau, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Franke', 'Affiliation': 'Department of Sport Science, University of Freiburg, Breisgau, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Leukel', 'Affiliation': 'Department of Sport Science, University of Freiburg, Breisgau, Germany.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002597'] 398,30161088,"Effects of 6-Week Static Stretching of Knee Extensors on Flexibility, Muscle Strength, Jump Performance, and Muscle Endurance.","ABSTRACT Ikeda, N and Ryushi, T. Effects of 6-week static stretching of knee extensors on flexibility, muscle strength, jump performance, and muscle endurance. J Strength Cond Res 35(3): 715-723, 2021-The purpose of this study was to evaluate the changes in flexibility and muscular performance after stretching training for 6 weeks. Twelve healthy young men were assigned to a stretching group and 13 to a control group. The subjects of the stretching group performed static stretching of knee extensors for 6 weeks. Knee flexion range of motion (KFROM), leg extension strength, rate of force development (RFD) in leg extension, jump performance (squat and countermovement jump height, and index of rebound jump), and strength decrement index of 50 repetitions of isokinetic knee extension (muscle endurance) were measured before and after the interventions. In the stretching group, KFROM significantly increased from 145.2 ± 17.3 to 158.7 ± 6.3° (p < 0.05), whereas RFD significantly improved from 10,173 ± 2,401 to 11,883 ± 2,494 N·s-1 (p < 0.05). By contrast, leg extension strength and jump performance of each jump type did not improve significantly. Furthermore, muscle endurance decreased significantly. All variables remained unchanged in the control group. In conclusion, 6 weeks of stretching training of knee extensors improved KFROM and RFD in leg extension, but not leg extension strength and jump performance; moreover, muscle endurance decreased. These findings indicate that this stretching training protocol can be used by athletes in sports who require high flexibility and those who require high-power exertion.",2021,"Knee flexion range of motion (KFROM), leg extension strength, rate of force development (RFD) in leg extension, jump performance (squat and countermovement jump height, and index of rebound jump), and strength decrement index of 50 repetitions of isokinetic knee extension (muscle endurance) were measured before and after the interventions.",['Twelve healthy young men'],"['J Strength Cond Res XX(X', '6-Week Static Stretching of Knee Extensors', 'stretching group performed static stretching of knee extensors']","['Flexibility, Muscle Strength, Jump Performance, and Muscle Endurance', 'KFROM', 'flexibility and muscular performance', 'flexibility, muscle strength, jump performance, and muscle endurance', 'leg extension strength and jump performance', 'KFROM and RFD in leg extension, but not leg extension strength and jump performance', 'Knee flexion range of motion (KFROM), leg extension strength, rate of force development (RFD) in leg extension, jump performance (squat and countermovement jump height, and index of rebound jump), and strength decrement index of 50 repetitions of isokinetic knee extension (muscle endurance', 'RFD', 'muscle endurance']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C2927794', 'cui_str': 'RFD'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}]",12.0,0.0145259,"Knee flexion range of motion (KFROM), leg extension strength, rate of force development (RFD) in leg extension, jump performance (squat and countermovement jump height, and index of rebound jump), and strength decrement index of 50 repetitions of isokinetic knee extension (muscle endurance) were measured before and after the interventions.","[{'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Ikeda', 'Affiliation': 'Faculty of Sport Sciences, Waseda University, Tokorozawa, Saitama, Japan; and.'}, {'ForeName': 'Tomoo', 'Initials': 'T', 'LastName': 'Ryushi', 'Affiliation': 'Faculty of Sports & Health Sciences, Daito Bunka University, Higashi-matsuyama, Saitama, Japan.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002819'] 399,31536654,"Long-term, prolonged-release tacrolimus-based immunosuppression in de novo kidney transplant recipients: 5-year prospective follow-up of the ADHERE study patients.","The objectives of this study were to assess long-term graft survival, patient survival, renal function, and acute rejections in de novo kidney transplant recipients, treated with once-daily prolonged-release tacrolimus-based therapy. The study was a 5-year non-interventional prospective follow-up of patients from the ADHERE study, a Phase IV 12-month open-label assessment of patients randomized to receive prolonged-release tacrolimus in combination with mycophenolate mofetil (MMF) (Arm 1) or sirolimus (Arm 2). From 838 patients in the randomized study, 587 were included in the long-term follow-up, of whom 510 completed the study at year 5. At 1 year post-transplant, graft and patient survival rates were 93.0% and 97.8%, respectively, and at 5 years were 84.0% and 90.8%, respectively. Cox proportional hazards analysis showed no association between graft loss, initial randomized treatment arm, donor age, donor type, or sex. The 5-year acute rejection-free survival rate was 77.4%, and biopsy-confirmed acute rejection-free survival rate was 86.0%. Renal function remained stable over the follow-up period: mean ± SD eGFR 4-variable modification diet in renal disease formula (MDRD4) was 52.3 ± 21.6 ml/min/1.73 m 2 at 6 months and 52.5 ± 23.0 ml/min/1.73 m 2 at 5 years post-transplant. These findings support the role of long-term once-daily prolonged-release tacrolimus-based immunosuppression, in combination with sirolimus or MMF, for renal transplant recipients in routine clinical practice.",2020,"The objectives of this study were to assess long-term graft survival, patient survival, renal function, and acute rejections in de novo kidney transplant recipients, treated with once-daily prolonged-release tacrolimus-based therapy.",['de novo kidney transplant recipients'],"['prolonged-release tacrolimus in combination with mycophenolate mofetil (MMF) (Arm 1) or sirolimus', 'tacrolimus-based immunosuppression', 'tacrolimus-based therapy']","['long-term graft survival, patient survival, renal function, and acute rejections']","[{'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}]","[{'cui': 'C4544856', 'cui_str': 'Prolonged-release (release characteristic)'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0021080', 'cui_str': 'Immunosuppression (Physiology)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}]",,0.0321247,"The objectives of this study were to assess long-term graft survival, patient survival, renal function, and acute rejections in de novo kidney transplant recipients, treated with once-daily prolonged-release tacrolimus-based therapy.","[{'ForeName': 'Oleg', 'Initials': 'O', 'LastName': 'Rummo', 'Affiliation': 'Republican Scientific and Practical Center (RSPC) for Organ and Tissue Transplantation, Minsk, Belarus.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Carmellini', 'Affiliation': 'Department of Medical, Surgical and Neuroscience, Policlinico Santa Maria alle Scotte, University of Siena, Siena, Italy.'}, {'ForeName': 'Nassim', 'Initials': 'N', 'LastName': 'Kamar', 'Affiliation': 'Department of Nephrology and Organ Transplantation, CHU Rangueil, Université Paul Sabatier Toulouse, Toulouse Cedex 9, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Durrbach', 'Affiliation': 'Nephrology Service, Centre Hospitalier de Bicetre, Le Kremlin Bicetre, France.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Mousson', 'Affiliation': 'Department of Nephrology-Transplantation, University Hospital Dijon, Dijon, France.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Caputo', 'Affiliation': 'UOC Nephrology 2, Dialysis and Transplantation, ARNAS Civico Palermo, Palermo, Italy.'}, {'ForeName': 'Zoltan', 'Initials': 'Z', 'LastName': 'Mathe', 'Affiliation': 'Transplantation and Surgery Clinic, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Maarten H L', 'Initials': 'MHL', 'LastName': 'Christiaans', 'Affiliation': 'Department of Internal Medicine/Division of Nephrology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Dirk R J', 'Initials': 'DRJ', 'LastName': 'Kuypers', 'Affiliation': 'Department of Nephrology, and Renal Transplantation, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Klempnauer', 'Affiliation': 'General, Visceral and Transplantation Surgery, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Swapneel', 'Initials': 'S', 'LastName': 'Anaokar', 'Affiliation': 'Astellas Pharma Europe Ltd, Chertsey, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hurst', 'Affiliation': 'Astellas Pharma Europe Ltd, Chertsey, UK.'}, {'ForeName': 'Gbenga', 'Initials': 'G', 'LastName': 'Kazeem', 'Affiliation': 'Astellas Pharma Europe Ltd, Chertsey, UK.'}, {'ForeName': 'Nasrullah', 'Initials': 'N', 'LastName': 'Undre', 'Affiliation': 'Astellas Pharma Europe Ltd, Chertsey, UK.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Lehner', 'Affiliation': 'General, Visceral and Transplantation Surgery, Hannover Medical School, Hannover, Germany.'}]",Transplant international : official journal of the European Society for Organ Transplantation,['10.1111/tri.13527'] 400,29927891,Using Sprint Velocity Decrement to Enhance Acute Sprint Performance.,"ABSTRACT Cochrane, DJ and Monaghan, D. Using sprint velocity decrement to enhance acute sprint performance. J Strength Cond Res 35(2): 442-448, 2021-Acute sled towing has the capability to elicit a potentiation. Currently, sled loading is determined from body mass (BM) percent. However, it may be more relevant to use a percentage of maximal sprint reduction to determine an individual's load. The purpose of this study was to determine if individualizing sled loads at 35 and 55% reduction in velocity would improve 20-m sprint performance. In addition, electromyography (EMG) was assessed to determine if any sprint-related improvements in velocity were due to changes in neural excitation. Twelve senior club male rugby union players performed familiarization and 2 sled towing sessions using a randomized, cross-over, and counterbalanced design. Testing sessions involved: baseline unresisted 20-m sprints, resisted sprint (35 and 55% reduction in velocity), and unresisted 20-m sprints at 2, 4, 6, 8, 12, and 16 minutes. The sled load to reduce maximal velocity by 35% significantly improved 20-m velocity (p <0.05, effect size [ES] = 0.21) compared with the heavier sled load (55% reduction in maximum velocity). A significant decline in sprint velocity occurred at 12 minutes (p < 0.01, ES = -0.61) and 16 minutes (p < 0.01, ES = -0.45) compared with baseline velocity. Other time intervals reported trivial small nonsignificant changes in sprint velocity (p >0.05). There was no significant change in EMG. Reducing sprint velocity provides an alternate method to determining sprint loading. Nonetheless, a greater range of reduced sprint velocity is required to assess if it is more effective than using BM percent procedure.",2021,"The sled load to reduce maximal velocity by 35% significantly improved 20-m velocity (p <0.05, effect size [ES] = 0.21) compared with the heavier sled load (55% reduction in maximum velocity).",['Twelve senior club male rugby union players performed'],"['J Strength Cond Res XX(X', 'electromyography (EMG', 'familiarization and 2 sled towing sessions']","['20-m velocity', 'individualizing sled loads', 'maximal velocity', 'acute sprint performance', 'EMG', 'sprint velocity', '20-m sprint performance', 'Acute Sprint Performance']","[{'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C1141000', 'cui_str': 'Sled, device (physical object)'}]","[{'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0336980', 'cui_str': 'Sledding'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}]",,0.0683675,"The sled load to reduce maximal velocity by 35% significantly improved 20-m velocity (p <0.05, effect size [ES] = 0.21) compared with the heavier sled load (55% reduction in maximum velocity).","[{'ForeName': 'Darryl J', 'Initials': 'DJ', 'LastName': 'Cochrane', 'Affiliation': 'School of Sport, Exercise and Nutrition, Massey University, Palmerston North, New Zealand.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Monaghan', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002707'] 401,29985223,Jump Training in Rugby Union Players: Barbell or Hexagonal Bar?,"ABSTRACT Weakley, JJS, Till, K, Read, DB, Leduc, C, Roe, GAB, Phibbs, PJ, Darrall-Jones, J, and Jones, B. Jump training in rugby union players: barbell or hexagonal bar?. J Strength Cond Res 35(3): 754-761, 2021-The countermovement jump (CMJ) is an exercise that can develop athletic performance. Using the conventional barbell (BAR) and hexagonal barbell (HEX) while jumping, the intensity can be increased. However, the bar that provides greater adaptations is unknown. Therefore, this study aimed to assess changes in loaded and unloaded CMJ with either a BAR or HEX across a 4-week mesocycle in rugby union players. Twenty-nine subjects were strength-matched and randomized into 2 groups. Subjects completed 3 sets of CMJ at 20% of 1 repetition maximum back squat, 3 times per week for 4 weeks, using either a BAR or HEX. Subjects completed an unloaded CMJ on a force plate before and after, whereas the highest peak concentric velocity during the jump squat was recorded in the first and last training sessions using a linear position transducer. Magnitude-based inferences assessed meaningful changes within- and between-groups. Possibly greater improvements in unloaded CMJ were found in the HEX group in jump height (effect size ± 90% confidence intervals: 0.27 ± 0.27), relative peak (0.21 ± 0.23), and mean power (0.32 ± 0.36). In addition, likely to very likely greater improvements were observed in the HEX group in peak velocity (0.33 ± 0.27), relative mean power (0.53 ± 0.30), mean force (0.47 ± 0.27), and 100-ms impulse (0.60 ± 0.48). Similar raw changes in jump squat peak velocity occurred (0.20-0.25 m·s-1), despite the likely greater ES occurring with the BAR (0.32 ± 0.26). These results indicate that training with the HEX leads to superior unloaded CMJ adaptations. In addition, practitioners should use either the HEX or BAR when aiming to enhance loaded jump ability.",2021,"Possibly greater improvements in unloaded CMJ were found in the HEX group in jump height (effect size ± 90% confidence intervals: 0.27 ± 0.27), relative peak (0.21 ± 0.23), and mean power (0.32 ± 0.36).","['rugby union players', 'Twenty-nine subjects were strength-matched and randomized into 2 groups']","['HEX', 'J Strength Cond Res XX(X', '2018-The countermovement jump (CMJ', 'unloaded CMJ', 'BAR or HEX', 'Jump Training', 'conventional barbell (BAR) and hexagonal barbell (HEX']","['Weakley, JJS, Till, K, Read, DB, Leduc, C, Roe, GAB, Phibbs, PJ, Darrall-Jones, J, and Jones, B. Jump training', 'jump squat peak velocity', 'highest peak concentric velocity', 'unloaded CMJ']","[{'cui': 'C0035945', 'cui_str': 'Rugby'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0993613', 'cui_str': 'Bar (basic dose form)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439744', 'cui_str': 'Concentric (qualifier value)'}]",29.0,0.0161079,"Possibly greater improvements in unloaded CMJ were found in the HEX group in jump height (effect size ± 90% confidence intervals: 0.27 ± 0.27), relative peak (0.21 ± 0.23), and mean power (0.32 ± 0.36).","[{'ForeName': 'Jonathon J S', 'Initials': 'JJS', 'LastName': 'Weakley', 'Affiliation': 'Institute for Sport, Physical Activity and Leisure, Leeds Beckett University, Leeds, West Yorkshire, United Kingdom.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Till', 'Affiliation': 'Institute for Sport, Physical Activity and Leisure, Leeds Beckett University, Leeds, West Yorkshire, United Kingdom.'}, {'ForeName': 'Dale B', 'Initials': 'DB', 'LastName': 'Read', 'Affiliation': 'Institute for Sport, Physical Activity and Leisure, Leeds Beckett University, Leeds, West Yorkshire, United Kingdom.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Leduc', 'Affiliation': 'Institute for Sport, Physical Activity and Leisure, Leeds Beckett University, Leeds, West Yorkshire, United Kingdom.'}, {'ForeName': 'Gregory A B', 'Initials': 'GAB', 'LastName': 'Roe', 'Affiliation': 'Institute for Sport, Physical Activity and Leisure, Leeds Beckett University, Leeds, West Yorkshire, United Kingdom.'}, {'ForeName': 'Padraic J', 'Initials': 'PJ', 'LastName': 'Phibbs', 'Affiliation': 'Institute for Sport, Physical Activity and Leisure, Leeds Beckett University, Leeds, West Yorkshire, United Kingdom.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Darrall-Jones', 'Affiliation': 'Institute for Sport, Physical Activity and Leisure, Leeds Beckett University, Leeds, West Yorkshire, United Kingdom.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Jones', 'Affiliation': 'Institute for Sport, Physical Activity and Leisure, Leeds Beckett University, Leeds, West Yorkshire, United Kingdom.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002742'] 402,29890086,Azithromycin for Early Pseudomonas Infection in Cystic Fibrosis. The OPTIMIZE Randomized Trial.,"RATIONALE New isolation of Pseudomonas aeruginosa (Pa) is generally treated with inhaled antipseudomonal antibiotics such as tobramycin inhalation solution (TIS). A therapeutic approach that complements traditional antimicrobial therapy by reducing the risk of pulmonary exacerbation and inflammation may ultimately prolong the time to Pa recurrence. OBJECTIVES To test the hypothesis that the addition of azithromycin to TIS in children with cystic fibrosis and early Pa decreases the risk of pulmonary exacerbation and prolongs the time to Pa recurrence. METHODS The OPTIMIZE (Optimizing Treatment for Early Pseudomonas aeruginosa Infection in Cystic Fibrosis) trial was a multicenter, double-blind, randomized, placebo-controlled, 18-month trial in children with CF, 6 months to 18 years of age, with early Pa. Azithromycin or placebo was given 3× weekly with standardized TIS. MEASUREMENTS AND MAIN RESULTS The primary endpoint was the time to pulmonary exacerbation requiring antibiotics and the secondary endpoint was the time to Pa recurrence, in addition to other clinical and safety outcomes. A total of 221 participants (111 placebo, 110 azithromycin) out of a planned 274 were enrolled. Enrollment was stopped early by the NHLBI because the trial had reached the prespecified interim boundary for efficacy. The risk of pulmonary exacerbation was reduced by 44% in the azithromycin group as compared with the placebo group (hazard ratio, 0.56; 95% confidence interval, 0.37-0.83; P = 0.004). Weight increased by 1.27 kg in the azithromycin group compared with the placebo group (95% confidence interval, 0.01-2.52; P = 0.046). No significant differences were seen in microbiological or other clinical or safety endpoints. CONCLUSIONS Azithromycin was associated with a significant reduction in the risk of pulmonary exacerbation and a sustained improvement in weight, but had no impact on microbiological outcomes in children with early Pa. Clinical trial registered with clinicaltrials.gov (NCT02054156).",2018,"Weight increased by 1.27 kg in the azithromycin group compared with the placebo group (95% confidence interval, 0.01-2.52; P = 0.046).","['Early Pseudomonas aeruginosa Infection in Cystic Fibrosis', 'children with CF, 6 months to 18 years of age, with early Pa', '221 participants (111 placebo, 110 azithromycin) out of a planned 274 were enrolled', 'was given 3× weekly with standardized TIS', 'children with cystic fibrosis', 'Cystic Fibrosis']","['placebo', 'Azithromycin', 'azithromycin', 'tobramycin inhalation solution (TIS', 'Azithromycin or placebo']","['microbiological outcomes', 'microbiological or other clinical or safety endpoints', 'risk of pulmonary exacerbation and prolongs the time to Pa recurrence', 'time to pulmonary exacerbation requiring antibiotics', 'Weight', 'risk of pulmonary exacerbation', 'time to Pa recurrence, in addition to other clinical and safety outcomes']","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0033808', 'cui_str': 'Flavimonas'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0040341', 'cui_str': 'Tobramycin'}, {'cui': 'C1154181', 'cui_str': 'Inhalation Solution'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]",274.0,0.656618,"Weight increased by 1.27 kg in the azithromycin group compared with the placebo group (95% confidence interval, 0.01-2.52; P = 0.046).","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Mayer-Hamblett', 'Affiliation': '1 Department of Pediatrics and.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Retsch-Bogart', 'Affiliation': '4 Department of Pediatrics, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Kloster', 'Affiliation': ""2 Seattle Children's Hospital, Seattle, Washington.""}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Accurso', 'Affiliation': '5 Department of Pediatrics, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Rosenfeld', 'Affiliation': '1 Department of Pediatrics and.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Albers', 'Affiliation': '7 Department of Pediatrics, Saint Louis University School of Medicine, Saint Louis, Missouri.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Black', 'Affiliation': ""8 Children's Mercy Hospital, Kansas City, Missouri.""}, {'ForeName': 'Perry', 'Initials': 'P', 'LastName': 'Brown', 'Affiliation': ""9 St. Luke's Regional Medical Center, Boise, Idaho.""}, {'ForeName': 'AnneMarie', 'Initials': 'A', 'LastName': 'Cairns', 'Affiliation': '10 Maine Medical Center, Portland, Maine.'}, {'ForeName': 'Stephanie D', 'Initials': 'SD', 'LastName': 'Davis', 'Affiliation': '11 Indiana University Hospital, Indianapolis, Indiana.'}, {'ForeName': 'Gavin R', 'Initials': 'GR', 'LastName': 'Graff', 'Affiliation': '13 Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Gwendolyn S', 'Initials': 'GS', 'LastName': 'Kerby', 'Affiliation': '5 Department of Pediatrics, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Orenstein', 'Affiliation': ""15 UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Buckingham', 'Affiliation': ""2 Seattle Children's Hospital, Seattle, Washington.""}, {'ForeName': 'Bonnie W', 'Initials': 'BW', 'LastName': 'Ramsey', 'Affiliation': '1 Department of Pediatrics and.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201802-0215OC'] 403,29590008,Health-Related Quality-of-Life Analysis From KEYNOTE-045: A Phase III Study of Pembrolizumab Versus Chemotherapy for Previously Treated Advanced Urothelial Cancer.,"Purpose In the phase III KEYNOTE-045 study ( ClinicalTrials.gov identifier: NCT02256436), pembrolizumab significantly prolonged overall survival compared with investigator's choice of chemotherapy in patients with previously treated advanced urothelial cancer. Here, we report the results of health-related quality-of-life (HRQoL) analyses from the KEYNOTE-045 trial. Patients and Methods Patients were randomly assigned 1:1 to pembrolizumab 200 mg or investigator's choice of docetaxel 75 mg/m 2 , paclitaxel 175 mg/m 2 , or vinflunine 320 mg/m 2 administered intravenously every 3 weeks. Key prespecified HRQoL analyses were time to deterioration (TTD) and mean change from baseline to week 15 in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 global health status/quality-of-life score. Results Of 542 patients who were randomly assigned, 519 were included in HRQoL analyses (pembrolizumab, n = 266; chemotherapy, n = 253). HRQoL compliance was > 95% at baseline and approximately 88% at week 15 for both groups. Pembrolizumab prolonged TTD in global health status/quality-of-life score compared with chemotherapy (median, 3.5 months v 2.3 months; hazard ratio, 0.72; nominal one-sided P = .004). Mean (95% CI) change from baseline to week 15 in global health status/quality-of-life score was 0.69 (-2.40 to 3.77) with pembrolizumab and -8.36 (-11.84 to -4.89) with chemotherapy (mean difference, 9.05 points; 95% CI, 4.61 to 13.50; nominal two-sided P < .001). Conclusion Pembrolizumab prolonged TTD in HRQoL compared with chemotherapy. Patients who were treated with pembrolizumab had stable or improved global health status/quality of life, whereas those who were treated with investigator's choice of chemotherapy experienced declines in global health status/quality of life. Combined with efficacy and safety outcomes, these data support pembrolizumab as standard of care for patients with platinum-refractory advanced urothelial cancer.",2018,"Pembrolizumab prolonged TTD in global health status/quality-of-life score compared with chemotherapy (median, 3.5 months v 2.3 months; hazard ratio, 0.72; nominal one-sided P = .004).","['patients with previously treated advanced urothelial cancer', 'Previously Treated Advanced Urothelial Cancer', '542 patients who were randomly assigned, 519 were included in HRQoL analyses (pembrolizumab, n = 266; chemotherapy, n = 253', 'patients with platinum-refractory advanced urothelial cancer']","['chemotherapy', ""pembrolizumab 200 mg or investigator's choice of docetaxel 75 mg/m 2 , paclitaxel 175 mg/m 2 , or vinflunine 320 mg/m 2 administered intravenously every 3 weeks"", 'pembrolizumab', 'Pembrolizumab Versus Chemotherapy']","['global health status/quality of life', 'global health status/quality-of-life score', 'Cancer Quality of Life Questionnaire C30 global health status/quality-of-life score', 'Pembrolizumab prolonged TTD in global health status/quality-of-life score', 'HRQoL compliance', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0672663', 'cui_str': 'vinflunine'}, {'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",542.0,0.250662,"Pembrolizumab prolonged TTD in global health status/quality-of-life score compared with chemotherapy (median, 3.5 months v 2.3 months; hazard ratio, 0.72; nominal one-sided P = .004).","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Vaughn', 'Affiliation': 'David J. Vaughn, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA; Joaquim Bellmunt and Toni K. Choueiri, Dana-Farber Cancer Institute, Boston, MA; Yves Fradet, CHU de Québec-Université Laval, Quebec City, Quebec, Canada; Jae Lyun Lee, Asan Medical Center and University of Ulsan College of Medicine, Seoul, Republic of Korea; Lawrence Fong, University of California, San Francisco, San Francisco; David I. Quinn, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nicholas J. Vogelzang, Comprehensive Cancer Centers of Nevada, Las Vegas, NV; Miguel A. Climent, Fundación Instituto Valenciano de Oncología, Valencia, Spain; Daniel P. Petrylak, Smilow Cancer Hospital, Yale University, New Haven, CT; Andrea Necchi, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan; Cora N. Sternberg, San Camillo and Forlanini Hospitals, Rome, Italy; Winald Gerritsen, Radboud University Medical Center, Nijmegen; Ronald de Wit, Erasmus University Medical Center Cancer Institute, Rotterdam, the Netherlands; Howard Gurney, Westmead Hospital and Macquarie University, Sydney, New South Wales, Australia; Stephane Culine, Hôpital Saint-Louis, Paris, France; Yabing Mai, Haojie Li, and Rodolfo F. Perini, Merk & Co., Inc., Kenilworth, NJ; and Dean F. Bajorin, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Bellmunt', 'Affiliation': 'David J. Vaughn, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA; Joaquim Bellmunt and Toni K. Choueiri, Dana-Farber Cancer Institute, Boston, MA; Yves Fradet, CHU de Québec-Université Laval, Quebec City, Quebec, Canada; Jae Lyun Lee, Asan Medical Center and University of Ulsan College of Medicine, Seoul, Republic of Korea; Lawrence Fong, University of California, San Francisco, San Francisco; David I. Quinn, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nicholas J. Vogelzang, Comprehensive Cancer Centers of Nevada, Las Vegas, NV; Miguel A. Climent, Fundación Instituto Valenciano de Oncología, Valencia, Spain; Daniel P. Petrylak, Smilow Cancer Hospital, Yale University, New Haven, CT; Andrea Necchi, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan; Cora N. Sternberg, San Camillo and Forlanini Hospitals, Rome, Italy; Winald Gerritsen, Radboud University Medical Center, Nijmegen; Ronald de Wit, Erasmus University Medical Center Cancer Institute, Rotterdam, the Netherlands; Howard Gurney, Westmead Hospital and Macquarie University, Sydney, New South Wales, Australia; Stephane Culine, Hôpital Saint-Louis, Paris, France; Yabing Mai, Haojie Li, and Rodolfo F. Perini, Merk & Co., Inc., Kenilworth, NJ; and Dean F. Bajorin, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Fradet', 'Affiliation': 'David J. Vaughn, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA; Joaquim Bellmunt and Toni K. Choueiri, Dana-Farber Cancer Institute, Boston, MA; Yves Fradet, CHU de Québec-Université Laval, Quebec City, Quebec, Canada; Jae Lyun Lee, Asan Medical Center and University of Ulsan College of Medicine, Seoul, Republic of Korea; Lawrence Fong, University of California, San Francisco, San Francisco; David I. Quinn, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nicholas J. Vogelzang, Comprehensive Cancer Centers of Nevada, Las Vegas, NV; Miguel A. Climent, Fundación Instituto Valenciano de Oncología, Valencia, Spain; Daniel P. Petrylak, Smilow Cancer Hospital, Yale University, New Haven, CT; Andrea Necchi, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan; Cora N. Sternberg, San Camillo and Forlanini Hospitals, Rome, Italy; Winald Gerritsen, Radboud University Medical Center, Nijmegen; Ronald de Wit, Erasmus University Medical Center Cancer Institute, Rotterdam, the Netherlands; Howard Gurney, Westmead Hospital and Macquarie University, Sydney, New South Wales, Australia; Stephane Culine, Hôpital Saint-Louis, Paris, France; Yabing Mai, Haojie Li, and Rodolfo F. Perini, Merk & Co., Inc., Kenilworth, NJ; and Dean F. Bajorin, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Jae Lyun', 'Initials': 'JL', 'LastName': 'Lee', 'Affiliation': 'David J. Vaughn, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA; Joaquim Bellmunt and Toni K. Choueiri, Dana-Farber Cancer Institute, Boston, MA; Yves Fradet, CHU de Québec-Université Laval, Quebec City, Quebec, Canada; Jae Lyun Lee, Asan Medical Center and University of Ulsan College of Medicine, Seoul, Republic of Korea; Lawrence Fong, University of California, San Francisco, San Francisco; David I. Quinn, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nicholas J. Vogelzang, Comprehensive Cancer Centers of Nevada, Las Vegas, NV; Miguel A. Climent, Fundación Instituto Valenciano de Oncología, Valencia, Spain; Daniel P. Petrylak, Smilow Cancer Hospital, Yale University, New Haven, CT; Andrea Necchi, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan; Cora N. Sternberg, San Camillo and Forlanini Hospitals, Rome, Italy; Winald Gerritsen, Radboud University Medical Center, Nijmegen; Ronald de Wit, Erasmus University Medical Center Cancer Institute, Rotterdam, the Netherlands; Howard Gurney, Westmead Hospital and Macquarie University, Sydney, New South Wales, Australia; Stephane Culine, Hôpital Saint-Louis, Paris, France; Yabing Mai, Haojie Li, and Rodolfo F. Perini, Merk & Co., Inc., Kenilworth, NJ; and Dean F. Bajorin, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Fong', 'Affiliation': 'David J. Vaughn, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA; Joaquim Bellmunt and Toni K. Choueiri, Dana-Farber Cancer Institute, Boston, MA; Yves Fradet, CHU de Québec-Université Laval, Quebec City, Quebec, Canada; Jae Lyun Lee, Asan Medical Center and University of Ulsan College of Medicine, Seoul, Republic of Korea; Lawrence Fong, University of California, San Francisco, San Francisco; David I. Quinn, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nicholas J. Vogelzang, Comprehensive Cancer Centers of Nevada, Las Vegas, NV; Miguel A. Climent, Fundación Instituto Valenciano de Oncología, Valencia, Spain; Daniel P. Petrylak, Smilow Cancer Hospital, Yale University, New Haven, CT; Andrea Necchi, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan; Cora N. Sternberg, San Camillo and Forlanini Hospitals, Rome, Italy; Winald Gerritsen, Radboud University Medical Center, Nijmegen; Ronald de Wit, Erasmus University Medical Center Cancer Institute, Rotterdam, the Netherlands; Howard Gurney, Westmead Hospital and Macquarie University, Sydney, New South Wales, Australia; Stephane Culine, Hôpital Saint-Louis, Paris, France; Yabing Mai, Haojie Li, and Rodolfo F. Perini, Merk & Co., Inc., Kenilworth, NJ; and Dean F. Bajorin, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Vogelzang', 'Affiliation': 'David J. Vaughn, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA; Joaquim Bellmunt and Toni K. Choueiri, Dana-Farber Cancer Institute, Boston, MA; Yves Fradet, CHU de Québec-Université Laval, Quebec City, Quebec, Canada; Jae Lyun Lee, Asan Medical Center and University of Ulsan College of Medicine, Seoul, Republic of Korea; Lawrence Fong, University of California, San Francisco, San Francisco; David I. Quinn, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nicholas J. Vogelzang, Comprehensive Cancer Centers of Nevada, Las Vegas, NV; Miguel A. Climent, Fundación Instituto Valenciano de Oncología, Valencia, Spain; Daniel P. Petrylak, Smilow Cancer Hospital, Yale University, New Haven, CT; Andrea Necchi, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan; Cora N. Sternberg, San Camillo and Forlanini Hospitals, Rome, Italy; Winald Gerritsen, Radboud University Medical Center, Nijmegen; Ronald de Wit, Erasmus University Medical Center Cancer Institute, Rotterdam, the Netherlands; Howard Gurney, Westmead Hospital and Macquarie University, Sydney, New South Wales, Australia; Stephane Culine, Hôpital Saint-Louis, Paris, France; Yabing Mai, Haojie Li, and Rodolfo F. Perini, Merk & Co., Inc., Kenilworth, NJ; and Dean F. Bajorin, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Climent', 'Affiliation': 'David J. Vaughn, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA; Joaquim Bellmunt and Toni K. Choueiri, Dana-Farber Cancer Institute, Boston, MA; Yves Fradet, CHU de Québec-Université Laval, Quebec City, Quebec, Canada; Jae Lyun Lee, Asan Medical Center and University of Ulsan College of Medicine, Seoul, Republic of Korea; Lawrence Fong, University of California, San Francisco, San Francisco; David I. Quinn, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nicholas J. Vogelzang, Comprehensive Cancer Centers of Nevada, Las Vegas, NV; Miguel A. Climent, Fundación Instituto Valenciano de Oncología, Valencia, Spain; Daniel P. Petrylak, Smilow Cancer Hospital, Yale University, New Haven, CT; Andrea Necchi, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan; Cora N. Sternberg, San Camillo and Forlanini Hospitals, Rome, Italy; Winald Gerritsen, Radboud University Medical Center, Nijmegen; Ronald de Wit, Erasmus University Medical Center Cancer Institute, Rotterdam, the Netherlands; Howard Gurney, Westmead Hospital and Macquarie University, Sydney, New South Wales, Australia; Stephane Culine, Hôpital Saint-Louis, Paris, France; Yabing Mai, Haojie Li, and Rodolfo F. Perini, Merk & Co., Inc., Kenilworth, NJ; and Dean F. Bajorin, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Petrylak', 'Affiliation': 'David J. Vaughn, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA; Joaquim Bellmunt and Toni K. Choueiri, Dana-Farber Cancer Institute, Boston, MA; Yves Fradet, CHU de Québec-Université Laval, Quebec City, Quebec, Canada; Jae Lyun Lee, Asan Medical Center and University of Ulsan College of Medicine, Seoul, Republic of Korea; Lawrence Fong, University of California, San Francisco, San Francisco; David I. Quinn, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nicholas J. Vogelzang, Comprehensive Cancer Centers of Nevada, Las Vegas, NV; Miguel A. Climent, Fundación Instituto Valenciano de Oncología, Valencia, Spain; Daniel P. Petrylak, Smilow Cancer Hospital, Yale University, New Haven, CT; Andrea Necchi, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan; Cora N. Sternberg, San Camillo and Forlanini Hospitals, Rome, Italy; Winald Gerritsen, Radboud University Medical Center, Nijmegen; Ronald de Wit, Erasmus University Medical Center Cancer Institute, Rotterdam, the Netherlands; Howard Gurney, Westmead Hospital and Macquarie University, Sydney, New South Wales, Australia; Stephane Culine, Hôpital Saint-Louis, Paris, France; Yabing Mai, Haojie Li, and Rodolfo F. Perini, Merk & Co., Inc., Kenilworth, NJ; and Dean F. Bajorin, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': 'David J. Vaughn, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA; Joaquim Bellmunt and Toni K. Choueiri, Dana-Farber Cancer Institute, Boston, MA; Yves Fradet, CHU de Québec-Université Laval, Quebec City, Quebec, Canada; Jae Lyun Lee, Asan Medical Center and University of Ulsan College of Medicine, Seoul, Republic of Korea; Lawrence Fong, University of California, San Francisco, San Francisco; David I. Quinn, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nicholas J. Vogelzang, Comprehensive Cancer Centers of Nevada, Las Vegas, NV; Miguel A. Climent, Fundación Instituto Valenciano de Oncología, Valencia, Spain; Daniel P. Petrylak, Smilow Cancer Hospital, Yale University, New Haven, CT; Andrea Necchi, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan; Cora N. Sternberg, San Camillo and Forlanini Hospitals, Rome, Italy; Winald Gerritsen, Radboud University Medical Center, Nijmegen; Ronald de Wit, Erasmus University Medical Center Cancer Institute, Rotterdam, the Netherlands; Howard Gurney, Westmead Hospital and Macquarie University, Sydney, New South Wales, Australia; Stephane Culine, Hôpital Saint-Louis, Paris, France; Yabing Mai, Haojie Li, and Rodolfo F. Perini, Merk & Co., Inc., Kenilworth, NJ; and Dean F. Bajorin, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Necchi', 'Affiliation': 'David J. Vaughn, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA; Joaquim Bellmunt and Toni K. Choueiri, Dana-Farber Cancer Institute, Boston, MA; Yves Fradet, CHU de Québec-Université Laval, Quebec City, Quebec, Canada; Jae Lyun Lee, Asan Medical Center and University of Ulsan College of Medicine, Seoul, Republic of Korea; Lawrence Fong, University of California, San Francisco, San Francisco; David I. Quinn, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nicholas J. Vogelzang, Comprehensive Cancer Centers of Nevada, Las Vegas, NV; Miguel A. Climent, Fundación Instituto Valenciano de Oncología, Valencia, Spain; Daniel P. Petrylak, Smilow Cancer Hospital, Yale University, New Haven, CT; Andrea Necchi, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan; Cora N. Sternberg, San Camillo and Forlanini Hospitals, Rome, Italy; Winald Gerritsen, Radboud University Medical Center, Nijmegen; Ronald de Wit, Erasmus University Medical Center Cancer Institute, Rotterdam, the Netherlands; Howard Gurney, Westmead Hospital and Macquarie University, Sydney, New South Wales, Australia; Stephane Culine, Hôpital Saint-Louis, Paris, France; Yabing Mai, Haojie Li, and Rodolfo F. Perini, Merk & Co., Inc., Kenilworth, NJ; and Dean F. Bajorin, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Winald', 'Initials': 'W', 'LastName': 'Gerritsen', 'Affiliation': 'David J. Vaughn, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA; Joaquim Bellmunt and Toni K. Choueiri, Dana-Farber Cancer Institute, Boston, MA; Yves Fradet, CHU de Québec-Université Laval, Quebec City, Quebec, Canada; Jae Lyun Lee, Asan Medical Center and University of Ulsan College of Medicine, Seoul, Republic of Korea; Lawrence Fong, University of California, San Francisco, San Francisco; David I. Quinn, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nicholas J. Vogelzang, Comprehensive Cancer Centers of Nevada, Las Vegas, NV; Miguel A. Climent, Fundación Instituto Valenciano de Oncología, Valencia, Spain; Daniel P. Petrylak, Smilow Cancer Hospital, Yale University, New Haven, CT; Andrea Necchi, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan; Cora N. Sternberg, San Camillo and Forlanini Hospitals, Rome, Italy; Winald Gerritsen, Radboud University Medical Center, Nijmegen; Ronald de Wit, Erasmus University Medical Center Cancer Institute, Rotterdam, the Netherlands; Howard Gurney, Westmead Hospital and Macquarie University, Sydney, New South Wales, Australia; Stephane Culine, Hôpital Saint-Louis, Paris, France; Yabing Mai, Haojie Li, and Rodolfo F. Perini, Merk & Co., Inc., Kenilworth, NJ; and Dean F. Bajorin, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Gurney', 'Affiliation': 'David J. Vaughn, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA; Joaquim Bellmunt and Toni K. Choueiri, Dana-Farber Cancer Institute, Boston, MA; Yves Fradet, CHU de Québec-Université Laval, Quebec City, Quebec, Canada; Jae Lyun Lee, Asan Medical Center and University of Ulsan College of Medicine, Seoul, Republic of Korea; Lawrence Fong, University of California, San Francisco, San Francisco; David I. Quinn, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nicholas J. Vogelzang, Comprehensive Cancer Centers of Nevada, Las Vegas, NV; Miguel A. Climent, Fundación Instituto Valenciano de Oncología, Valencia, Spain; Daniel P. Petrylak, Smilow Cancer Hospital, Yale University, New Haven, CT; Andrea Necchi, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan; Cora N. Sternberg, San Camillo and Forlanini Hospitals, Rome, Italy; Winald Gerritsen, Radboud University Medical Center, Nijmegen; Ronald de Wit, Erasmus University Medical Center Cancer Institute, Rotterdam, the Netherlands; Howard Gurney, Westmead Hospital and Macquarie University, Sydney, New South Wales, Australia; Stephane Culine, Hôpital Saint-Louis, Paris, France; Yabing Mai, Haojie Li, and Rodolfo F. Perini, Merk & Co., Inc., Kenilworth, NJ; and Dean F. Bajorin, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Quinn', 'Affiliation': 'David J. Vaughn, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA; Joaquim Bellmunt and Toni K. Choueiri, Dana-Farber Cancer Institute, Boston, MA; Yves Fradet, CHU de Québec-Université Laval, Quebec City, Quebec, Canada; Jae Lyun Lee, Asan Medical Center and University of Ulsan College of Medicine, Seoul, Republic of Korea; Lawrence Fong, University of California, San Francisco, San Francisco; David I. Quinn, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nicholas J. Vogelzang, Comprehensive Cancer Centers of Nevada, Las Vegas, NV; Miguel A. Climent, Fundación Instituto Valenciano de Oncología, Valencia, Spain; Daniel P. Petrylak, Smilow Cancer Hospital, Yale University, New Haven, CT; Andrea Necchi, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan; Cora N. Sternberg, San Camillo and Forlanini Hospitals, Rome, Italy; Winald Gerritsen, Radboud University Medical Center, Nijmegen; Ronald de Wit, Erasmus University Medical Center Cancer Institute, Rotterdam, the Netherlands; Howard Gurney, Westmead Hospital and Macquarie University, Sydney, New South Wales, Australia; Stephane Culine, Hôpital Saint-Louis, Paris, France; Yabing Mai, Haojie Li, and Rodolfo F. Perini, Merk & Co., Inc., Kenilworth, NJ; and Dean F. Bajorin, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Culine', 'Affiliation': 'David J. Vaughn, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA; Joaquim Bellmunt and Toni K. Choueiri, Dana-Farber Cancer Institute, Boston, MA; Yves Fradet, CHU de Québec-Université Laval, Quebec City, Quebec, Canada; Jae Lyun Lee, Asan Medical Center and University of Ulsan College of Medicine, Seoul, Republic of Korea; Lawrence Fong, University of California, San Francisco, San Francisco; David I. Quinn, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nicholas J. Vogelzang, Comprehensive Cancer Centers of Nevada, Las Vegas, NV; Miguel A. Climent, Fundación Instituto Valenciano de Oncología, Valencia, Spain; Daniel P. Petrylak, Smilow Cancer Hospital, Yale University, New Haven, CT; Andrea Necchi, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan; Cora N. Sternberg, San Camillo and Forlanini Hospitals, Rome, Italy; Winald Gerritsen, Radboud University Medical Center, Nijmegen; Ronald de Wit, Erasmus University Medical Center Cancer Institute, Rotterdam, the Netherlands; Howard Gurney, Westmead Hospital and Macquarie University, Sydney, New South Wales, Australia; Stephane Culine, Hôpital Saint-Louis, Paris, France; Yabing Mai, Haojie Li, and Rodolfo F. Perini, Merk & Co., Inc., Kenilworth, NJ; and Dean F. Bajorin, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'David J. Vaughn, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA; Joaquim Bellmunt and Toni K. Choueiri, Dana-Farber Cancer Institute, Boston, MA; Yves Fradet, CHU de Québec-Université Laval, Quebec City, Quebec, Canada; Jae Lyun Lee, Asan Medical Center and University of Ulsan College of Medicine, Seoul, Republic of Korea; Lawrence Fong, University of California, San Francisco, San Francisco; David I. Quinn, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nicholas J. Vogelzang, Comprehensive Cancer Centers of Nevada, Las Vegas, NV; Miguel A. Climent, Fundación Instituto Valenciano de Oncología, Valencia, Spain; Daniel P. Petrylak, Smilow Cancer Hospital, Yale University, New Haven, CT; Andrea Necchi, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan; Cora N. Sternberg, San Camillo and Forlanini Hospitals, Rome, Italy; Winald Gerritsen, Radboud University Medical Center, Nijmegen; Ronald de Wit, Erasmus University Medical Center Cancer Institute, Rotterdam, the Netherlands; Howard Gurney, Westmead Hospital and Macquarie University, Sydney, New South Wales, Australia; Stephane Culine, Hôpital Saint-Louis, Paris, France; Yabing Mai, Haojie Li, and Rodolfo F. Perini, Merk & Co., Inc., Kenilworth, NJ; and Dean F. Bajorin, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Yabing', 'Initials': 'Y', 'LastName': 'Mai', 'Affiliation': 'David J. Vaughn, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA; Joaquim Bellmunt and Toni K. Choueiri, Dana-Farber Cancer Institute, Boston, MA; Yves Fradet, CHU de Québec-Université Laval, Quebec City, Quebec, Canada; Jae Lyun Lee, Asan Medical Center and University of Ulsan College of Medicine, Seoul, Republic of Korea; Lawrence Fong, University of California, San Francisco, San Francisco; David I. Quinn, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nicholas J. Vogelzang, Comprehensive Cancer Centers of Nevada, Las Vegas, NV; Miguel A. Climent, Fundación Instituto Valenciano de Oncología, Valencia, Spain; Daniel P. Petrylak, Smilow Cancer Hospital, Yale University, New Haven, CT; Andrea Necchi, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan; Cora N. Sternberg, San Camillo and Forlanini Hospitals, Rome, Italy; Winald Gerritsen, Radboud University Medical Center, Nijmegen; Ronald de Wit, Erasmus University Medical Center Cancer Institute, Rotterdam, the Netherlands; Howard Gurney, Westmead Hospital and Macquarie University, Sydney, New South Wales, Australia; Stephane Culine, Hôpital Saint-Louis, Paris, France; Yabing Mai, Haojie Li, and Rodolfo F. Perini, Merk & Co., Inc., Kenilworth, NJ; and Dean F. Bajorin, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Haojie', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'David J. Vaughn, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA; Joaquim Bellmunt and Toni K. Choueiri, Dana-Farber Cancer Institute, Boston, MA; Yves Fradet, CHU de Québec-Université Laval, Quebec City, Quebec, Canada; Jae Lyun Lee, Asan Medical Center and University of Ulsan College of Medicine, Seoul, Republic of Korea; Lawrence Fong, University of California, San Francisco, San Francisco; David I. Quinn, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nicholas J. Vogelzang, Comprehensive Cancer Centers of Nevada, Las Vegas, NV; Miguel A. Climent, Fundación Instituto Valenciano de Oncología, Valencia, Spain; Daniel P. Petrylak, Smilow Cancer Hospital, Yale University, New Haven, CT; Andrea Necchi, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan; Cora N. Sternberg, San Camillo and Forlanini Hospitals, Rome, Italy; Winald Gerritsen, Radboud University Medical Center, Nijmegen; Ronald de Wit, Erasmus University Medical Center Cancer Institute, Rotterdam, the Netherlands; Howard Gurney, Westmead Hospital and Macquarie University, Sydney, New South Wales, Australia; Stephane Culine, Hôpital Saint-Louis, Paris, France; Yabing Mai, Haojie Li, and Rodolfo F. Perini, Merk & Co., Inc., Kenilworth, NJ; and Dean F. Bajorin, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Rodolfo F', 'Initials': 'RF', 'LastName': 'Perini', 'Affiliation': 'David J. Vaughn, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA; Joaquim Bellmunt and Toni K. Choueiri, Dana-Farber Cancer Institute, Boston, MA; Yves Fradet, CHU de Québec-Université Laval, Quebec City, Quebec, Canada; Jae Lyun Lee, Asan Medical Center and University of Ulsan College of Medicine, Seoul, Republic of Korea; Lawrence Fong, University of California, San Francisco, San Francisco; David I. Quinn, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nicholas J. Vogelzang, Comprehensive Cancer Centers of Nevada, Las Vegas, NV; Miguel A. Climent, Fundación Instituto Valenciano de Oncología, Valencia, Spain; Daniel P. Petrylak, Smilow Cancer Hospital, Yale University, New Haven, CT; Andrea Necchi, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan; Cora N. Sternberg, San Camillo and Forlanini Hospitals, Rome, Italy; Winald Gerritsen, Radboud University Medical Center, Nijmegen; Ronald de Wit, Erasmus University Medical Center Cancer Institute, Rotterdam, the Netherlands; Howard Gurney, Westmead Hospital and Macquarie University, Sydney, New South Wales, Australia; Stephane Culine, Hôpital Saint-Louis, Paris, France; Yabing Mai, Haojie Li, and Rodolfo F. Perini, Merk & Co., Inc., Kenilworth, NJ; and Dean F. Bajorin, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Dean F', 'Initials': 'DF', 'LastName': 'Bajorin', 'Affiliation': 'David J. Vaughn, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA; Joaquim Bellmunt and Toni K. Choueiri, Dana-Farber Cancer Institute, Boston, MA; Yves Fradet, CHU de Québec-Université Laval, Quebec City, Quebec, Canada; Jae Lyun Lee, Asan Medical Center and University of Ulsan College of Medicine, Seoul, Republic of Korea; Lawrence Fong, University of California, San Francisco, San Francisco; David I. Quinn, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nicholas J. Vogelzang, Comprehensive Cancer Centers of Nevada, Las Vegas, NV; Miguel A. Climent, Fundación Instituto Valenciano de Oncología, Valencia, Spain; Daniel P. Petrylak, Smilow Cancer Hospital, Yale University, New Haven, CT; Andrea Necchi, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan; Cora N. Sternberg, San Camillo and Forlanini Hospitals, Rome, Italy; Winald Gerritsen, Radboud University Medical Center, Nijmegen; Ronald de Wit, Erasmus University Medical Center Cancer Institute, Rotterdam, the Netherlands; Howard Gurney, Westmead Hospital and Macquarie University, Sydney, New South Wales, Australia; Stephane Culine, Hôpital Saint-Louis, Paris, France; Yabing Mai, Haojie Li, and Rodolfo F. Perini, Merk & Co., Inc., Kenilworth, NJ; and Dean F. Bajorin, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'de Wit', 'Affiliation': 'David J. Vaughn, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA; Joaquim Bellmunt and Toni K. Choueiri, Dana-Farber Cancer Institute, Boston, MA; Yves Fradet, CHU de Québec-Université Laval, Quebec City, Quebec, Canada; Jae Lyun Lee, Asan Medical Center and University of Ulsan College of Medicine, Seoul, Republic of Korea; Lawrence Fong, University of California, San Francisco, San Francisco; David I. Quinn, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nicholas J. Vogelzang, Comprehensive Cancer Centers of Nevada, Las Vegas, NV; Miguel A. Climent, Fundación Instituto Valenciano de Oncología, Valencia, Spain; Daniel P. Petrylak, Smilow Cancer Hospital, Yale University, New Haven, CT; Andrea Necchi, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan; Cora N. Sternberg, San Camillo and Forlanini Hospitals, Rome, Italy; Winald Gerritsen, Radboud University Medical Center, Nijmegen; Ronald de Wit, Erasmus University Medical Center Cancer Institute, Rotterdam, the Netherlands; Howard Gurney, Westmead Hospital and Macquarie University, Sydney, New South Wales, Australia; Stephane Culine, Hôpital Saint-Louis, Paris, France; Yabing Mai, Haojie Li, and Rodolfo F. Perini, Merk & Co., Inc., Kenilworth, NJ; and Dean F. Bajorin, Memorial Sloan Kettering Cancer Center, New York, NY.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.2017.76.9562'] 404,31403367,Efficacy and safety of a new 10% topical minoxidil versus 5% topical minoxidil and placebo in the treatment of male androgenetic alopecia: a trichoscopic evaluation.,"INTRODUCTION Androgenetic alopecia is a stressful condition for males. Minoxidil 2% and 5% have been FDA approved for treatment of this condition. In literature, all studies have compared minoxidil 5% with 2%. Although other concentrations (2% to 12.5%) are available nowadays, we believe our study is the first to compare 10% versus 5% topical minoxidil in treatment of AGA. OBJECTIVE To compare the efficacy and safety of 5% topical minoxidil with 10% topical minoxidil and placebo in AGA treatment. MATERIALS AND METHODS 36-weeks, double-blinded, placebo-controlled, randomized trial. A total of 90 men with AGA. First group have applied 5% minoxidil solution, second group applied 10% minoxidil solution; or third placebo group. Efficacy was evaluated clinically and trichoscopically. RESULTS After 36 weeks of therapy; 5% topical minoxidil (0.47 ± 0.26) (0.59 ± 0.64) was significantly superior to 10% topical minoxidil (0.05 ± 0.13) (0.45 ± 0.74) and placebo (0.01 ± 0.05) (-0.03 ± 0.08) in terms of change from baseline in total vertex and frontal hair mean count respectively. Pull test change to negative in minoxidil 5%: (37%) patients after 6 month treatment, Minoxidil 10% group (37.5%) patients changed and in placebo group all patients after 6 month were the same (0%) change. No reported sexual dysfunction in all three groups. CONCLUSION Five percent of topical minoxidil was moderately superior to 10% topical minoxidil and placebo in increasing hair regrowth opposite to the expected, the irritation was marked for 10% topical minoxidil. Psychosocial stress after 10% usage were worsen by the shedding, irritation compared to their high expectation in comparison to 5% usage.",2021,"5%topical minoxidil was moderately superior to10%topical minoxidil and placebo in increasing hair regrowth opposite to the expected,the irritation was marked for10%topical minoxidil.","['males', 'male androgenetic alopecia']","['minoxidil and placebo', 'minoxidil with10%topical minoxidil and placebo', 'placebo', 'Minoxidil', 'minoxidil solution;or third placebo', 'new 10% topical minoxidil', '5%topical minoxidil', 'minoxidil solution', 'minoxidil']","['sexual dysfunction', 'Efficacy', 'Efficacy and safety', 'total vertex and frontal hair mean count respectively']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0162311', 'cui_str': 'Pattern Baldness'}]","[{'cui': 'C0026196', 'cui_str': 'Minoxidil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0549622', 'cui_str': 'Sexual disorder (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0230003', 'cui_str': 'Vertex structure'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}]",,0.0303639,"5%topical minoxidil was moderately superior to10%topical minoxidil and placebo in increasing hair regrowth opposite to the expected,the irritation was marked for10%topical minoxidil.","[{'ForeName': 'Soheir', 'Initials': 'S', 'LastName': 'Ghonemy', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Abeer', 'Initials': 'A', 'LastName': 'Alarawi', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Hagar', 'Initials': 'H', 'LastName': 'Bessar', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}]",The Journal of dermatological treatment,['10.1080/09546634.2019.1654070'] 405,29570579,Moderate Load Resisted Sprints Do Not Improve Subsequent Sprint Performance in Varsity-Level Sprinters.,"ABSTRACT Thompson, K, Whinton, AK, Ferth, S, Spriet, LL, and Burr, JF. Moderate load resisted sprints do not improve subsequent sprint performance in varsity-level sprinters. J Strength Cond Res 35(1): 72-77, 2021-Resisted sprint training (RST) is commonly used for performance enhancement in athletics and team sports to develop acceleration ability. Evidence suggests that RST may be effective as a short-term intervention to improve successive sprints. Although these improvements have been measured in team sport athletes, limited research has considered the acute effects of RST training in sprint-trained athletes. Therefore, the aim of the current study was to determine whether performing RST with varsity-level sprinters using sled-equivalent resistive loads of ∼45% body mass results in a potentiation effect, leading to improvements in subsequent maximal sprint performance over 0-5 m and 0-20 m. Competitive sprinters (n = 20) were randomly assigned to perform a pre/post maximal 20-m sprint separated by either 3 resisted (RST group) or unresisted (URS group) sprints. The RST or URS protocol was performed on 4 occasions separated by at least 7 days. No significant differences were observed between the RST and URS groups comparing changes in sprint times over 0-5 m (URS Δ <0.01 ± 0.03 seconds, RST Δ <0.01 ± 0.03 seconds) and 0-20 m (URS Δ 0.013 ± 0.04 seconds, RST Δ <0.01 ± 0.04 seconds). We conclude that resisted sprints using sled-equivalent loads of 45% body mass are ineffective at inducing a potentiating effect on subsequent sprint performance in varsity-level sprinters. In this population of trained athletes, greater loads may be necessary to induce a potentiating effect.",2021,"No significant differences were observed between the RST and URS groups comparing changes in sprint times over 0-5 m (URS Δ = <0.01 s ± 0.03 s, RST Δ = <0.01 s ± 0.03 s) and 0-20 m (URS Δ = 0.013 s ± 0.04 s, RST Δ = <0.01 s ± 0.04 s).",['Competitive sprinters (n=20'],"['Resisted sprint training (RST', 'pre/post maximal 20 m sprint separated by either 3 resisted (RST group) or un-resisted (URS group) sprints', 'RST']","['Subsequent Sprint Performance', 'sprint times', 'subsequent maximal sprint performance']",[],"[{'cui': 'C0454374', 'cui_str': 'Sprint training (regime/therapy)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}]",,0.0737639,"No significant differences were observed between the RST and URS groups comparing changes in sprint times over 0-5 m (URS Δ = <0.01 s ± 0.03 s, RST Δ = <0.01 s ± 0.03 s) and 0-20 m (URS Δ = 0.013 s ± 0.04 s, RST Δ = <0.01 s ± 0.04 s).","[{'ForeName': 'Kyle M A', 'Initials': 'KMA', 'LastName': 'Thompson', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Alanna K', 'Initials': 'AK', 'LastName': 'Whinton', 'Affiliation': ''}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Ferth', 'Affiliation': ''}, {'ForeName': 'Lawrence L', 'Initials': 'LL', 'LastName': 'Spriet', 'Affiliation': ''}, {'ForeName': 'Jamie F', 'Initials': 'JF', 'LastName': 'Burr', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002524'] 406,31586424,"A randomized, double-blind trial investigating the efficacy of caspofungin versus amphotericin B deoxycholate in the treatment of invasive candidiasis in neonates and infants younger than 3 months of age.","OBJECTIVES Investigate the efficacy of caspofungin in participants <3 months of age with invasive Candida infection (ICI). METHODS This multicentre, randomized, double-blind, comparator-controlled, Phase 2 study (protocol MK0991-064; NCT01945281) enrolled participants <3 months of age with culture-confirmed ICI within 96 h of study entry. Participants were randomly assigned 2:1 to once-daily intravenous 2 mg/kg caspofungin or intravenous 1 mg/kg amphotericin B deoxycholate (dAMB). The primary endpoint was fungal-free survival (FFS) 2 weeks after treatment in the full-analysis-set (FAS) population, defined as participants with culture-confirmed ICI who received ≥1 dose of therapy. Planned enrolment was 90 participants. RESULTS Fifty-one participants were enrolled; 49 received treatment (caspofungin, n=33; dAMB, n=16); 2 additional participants did not have confirmed infections at study entry. The study was terminated after ∼ 3.5 years because of low enrolment. Forty-seven participants were included in the FAS population (caspofungin, n=31; dAMB, n=16). FFS rate at 2 weeks after treatment was 71.0% (22/31) in the caspofungin arm and 68.8% (11/16) in the dAMB arm [difference, stratified by weight, - 0.9% (95% CI, - 24.3%-27.7%)]. Adverse events developed in 84.8% (28/33) of participants in the caspofungin arm and 100% (16/16) in the dAMB arm. CONCLUSIONS Among neonates and infants with confirmed ICI, FFS at 2 weeks was similar in the caspofungin and dAMB treatment arms. A smaller proportion of participants who received caspofungin experienced adverse events.",2020,"Adverse events developed in 84.8% (28/33) of participants in the caspofungin arm and 100% (16/16) in the dAMB arm. ","['Fifty-one participants were enrolled; 49 received treatment (caspofungin, n=33; dAMB, n=16); 2 additional participants did not have confirmed infections at study entry', 'invasive candidiasis in neonates and infants younger than 3\u2009months of age', 'Phase 2 study (protocol MK0991-064; NCT01945281) enrolled participants <3\u2009months of age with culture-confirmed ICI within 96\u2009h of study entry', 'participants <3\u2009months of age with invasive Candida infection (ICI', 'Forty-seven participants were included in the FAS population (caspofungin, n=31; dAMB, n=16']","['daily intravenous 2\u2009mg/kg caspofungin or intravenous 1\u2009mg/kg amphotericin B deoxycholate (dAMB', 'caspofungin versus amphotericin B deoxycholate', 'caspofungin']","['Adverse events', 'FFS rate', 'adverse events', 'fungal-free survival (FFS']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0537894', 'cui_str': 'Caspofungin'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0537895', 'cui_str': 'MK0991'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0006840', 'cui_str': 'Moniliasis'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0537894', 'cui_str': 'Caspofungin'}, {'cui': 'C0051761', 'cui_str': 'D-AmB cpd'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",51.0,0.624103,"Adverse events developed in 84.8% (28/33) of participants in the caspofungin arm and 100% (16/16) in the dAMB arm. ","[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Firdose Lambey', 'Initials': 'FL', 'LastName': 'Nakwa', 'Affiliation': 'Chris Hani Baragwanath Academic Hospital, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Fábio', 'Initials': 'F', 'LastName': 'Araujo Motta', 'Affiliation': 'Hospital Pequeno Príncipe, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Dorr', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Leah J', 'Initials': 'LJ', 'LastName': 'Anderson', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Kartsonis', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz398'] 407,29389691,Effect of Ischemic Preconditioning on Maximal Swimming Performance.,"ABSTRACT Williams, N, Russell, M, Cook, CJ, and Kilduff, LP. Effect of ischemic preconditioning on maximal swimming performance. J Strength Cond Res 35(1): 221-226, 2021-The effect of ischemic preconditioning (IPC) on swimming performance was examined. Using a randomized, crossover design, national- and international-level swimmers (n = 20; 14 men, 6 women) participated in 3 trials (Con, IPC-2h, and IPC-24h). Lower-body IPC (4 × 5-minute bilateral blood flow restriction at 160-228 mm Hg and 5-minute reperfusion) was used 2 hours (IPC-2h) or 24 hours (IPC-24h) before a self-selected (100 m, n = 15; 200 m, n = 5) swimming time trial (TT). The Con trial used a sham intervention (15 mm Hg) 2 hours before exercise. All trials required a 40-minute standardized precompetition swimming warm-up (followed by 20-minute rest; replicating precompetition call room procedures) 1 hour before TT. Capillary blood (pH, blood gases, and lactate concentrations) was taken immediately before and after IPC, before TT and after TT. No effects on TT for 100 m (P = 0.995; IPC-2h: 64.94 ± 8.33 seconds; IPC-24h: 64.67 ± 8.50 seconds; Con: 64.94 ± 8.24 seconds), 200 m (P = 0.405; IPC-2h: 127.70 ± 10.66 seconds; IPC-24h: 129.26 ± 12.99 seconds; Con: 130.19 ± 10.27 seconds), or combined total time (IPC-2h: 84.27 ± 31.52 seconds; IPC-24h: 79.87 ± 29.72 seconds; Con: 80.55 ± 31.35 seconds) were observed after IPC. Base excess (IPC-2h: -13.37 ± 8.90 mmol·L-1; Con: -13.35 ± 7.07 mmol·L-1; IPC-24h: -16.53 ± 4.65 mmol·L-1), pH (0.22 ± 0.08; all conditions), bicarbonate (IPC-2h: -11.66 ± 3.52 mmol·L-1; Con: -11.62 ± 5.59 mmol·L-1; IPC-24h: -8.47 ± 9.02 mmol·L-1), total carbon dioxide (IPC-2h: -12.90 ± 3.92 mmol·L-1; Con: -11.55 ± 7.61 mmol·L-1; IPC-24h: 9.90 ± 8.40 mmol·L-1), percentage oxygen saturation (IPC-2h: -0.16 ± 1.86%; Con: +0.20 ± 1.93%; IPC-24h: +0.47 ± 2.10%), and blood lactate (IPC-2h: +12.87 ± 3.62 mmol·L-1; Con: +12.41 ± 4.02 mmol·L-1; IPC-24h: +13.27 ± 3.81 mmol·L-1) were influenced by swimming TT (P < 0.001), but not condition (all P > 0.05). No effect of IPC was seen when applied 2 or 24 hours before swimming TT on any indices of performance or physiological measures recorded.",2021,No effects on TT for 100 m (P=0.995; IPC-2h: 64.94±8.33 s; IPC-24h:,"['National-and International-level swimmers (n=20; 14 males, 6 females) participated in three trials (Con, IPC-2h, IPC-24h']","['IPC-24h', '40-min standardized pre-competition swimming warm-up (followed by 20-min rest; replicating pre-competition call room procedures) 1h before TT', 'IPC', 'ischemic preconditioning (IPC', 'Ischemic Preconditioning', 'bicarbonate (IPC-2h: -11.66±3.52 mmol⋅L; Con: -11.62±5.59 mmol⋅L; IPC-24h: -8.47±9.02 mmol⋅L), total carbon dioxide (IPC-2h: -12.90±3.92 mmol⋅L; Con: -11.55±7.61 mmol⋅L; IPC-24h']","['Maximal Swimming Performance', 'percentage oxygen saturation', 'blood lactate (IPC-2h: +12.87±3.62 mmol⋅L', 'Capillary blood (pH, blood gases and lactate concentrations']","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0450068', 'cui_str': 'Swimmer (person)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0005367', 'cui_str': 'Hydrogen Carbonates'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood (substance)'}, {'cui': 'C0005800', 'cui_str': 'Blood Gas Analysis'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0974222,No effects on TT for 100 m (P=0.995; IPC-2h: 64.94±8.33 s; IPC-24h:,"[{'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Williams', 'Affiliation': 'Applied Sports Technology Exercise and Medicine Research Center (A-STEM), Swansea University, Swansea, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Russell', 'Affiliation': 'School of Social and Health Sciences, Leeds Trinity University, Leeds, United Kingdom; and.'}, {'ForeName': 'Christian J', 'Initials': 'CJ', 'LastName': 'Cook', 'Affiliation': 'Welsh Institute for Performance Solutions, Swansea, UK.'}, {'ForeName': 'Liam P', 'Initials': 'LP', 'LastName': 'Kilduff', 'Affiliation': 'Applied Sports Technology Exercise and Medicine Research Center (A-STEM), Swansea University, Swansea, United Kingdom.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002485'] 408,29489719,Vertical and Horizontal Asymmetries Are Related to Slower Sprinting and Jump Performance in Elite Youth Female Soccer Players.,"ABSTRACT Bishop, C, Read, P, McCubbine, J, and Turner, A. Vertical and horizontal asymmetries are related to slower sprinting and jump performance in elite youth female soccer players. J Strength Cond Res 35(1): 56-63, 2021-Interlimb asymmetries have been shown to be greater during vertical jumping compared with horizontal jumping. Notable interlimb differences have also been established at an early age in male youth soccer players. Furthermore, given the multiplanar nature of soccer, establishing between-limb differences from multiple jump tests is warranted. At present, a paucity of data exists regarding asymmetries in youth female soccer players and their effects on physical performance. The aims of this study were to quantify interlimb asymmetries from unilateral jump tests and examine their effects on speed and jump performance. Nineteen elite youth female soccer players performed a single-leg countermovement jump (SLCMJ), single, triple, and crossover hops for distance, and a 20-m sprint test. Test reliability was good to excellent (intraclass correlation coefficient = 0.81-0.99) and variability acceptable (coefficient of variation = 1.74-5.42%). A 1-way analysis of variance highlighted larger asymmetries from the SLCMJ compared with all other jump tests (p < 0.05). Pearson's correlations portrayed significant relationships between vertical asymmetries from the SLCMJ and slower sprint times (r = 0.49-0.59). Significant negative relationships were also found between horizontal asymmetries during the triple hop test and horizontal jump performance (r = -0.47 to -0.58) and vertical asymmetries during the SLCMJ and vertical jump performance (r = -0.47 to -0.53). The results from this study highlight that the SLCMJ seems to be the most appropriate jump test for identifying between-limb differences with values ∼12% showing negative associations with sprint times. Furthermore, larger asymmetries are associated with reduced jump performance and would appear to be direction specific. Practitioners can use this information as normative data to be mindful of when quantifying interlimb asymmetries and assessing their potential impact on physical performance in youth female soccer players.",2021,A one-way ANOVA highlighted larger asymmetries from the SLCMJ compared to all other jump tests (p < 0.05).,"['youth female soccer players', 'Elite Youth Female Soccer Players', 'Nineteen elite youth female soccer players', 'male youth soccer players']","['SLCMJ', 'single leg countermovement jump (SLCMJ), single, triple, and crossover hops for distance and a 20 m sprint test']","['speed and jump performance', 'vertical asymmetries during the SLCMJ and vertical jump performance', 'Test reliability', 'horizontal jump performance']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C4018995', 'cui_str': 'Hop'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]","[{'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}]",,0.0188087,A one-way ANOVA highlighted larger asymmetries from the SLCMJ compared to all other jump tests (p < 0.05).,"[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bishop', 'Affiliation': 'London Sport Institute, School of Science and Technology, Middlesex University, London, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Read', 'Affiliation': 'Athlete Health and Performance Research Center, Aspetar Orthopaedic and Sports Medicine Hospital, Doha, Qatar; and.'}, {'ForeName': 'Jermaine', 'Initials': 'J', 'LastName': 'McCubbine', 'Affiliation': 'Arsenal Football Club Training Ground, St. Albans, United Kingdom.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Turner', 'Affiliation': 'London Sport Institute, School of Science and Technology, Middlesex University, London, United Kingdom.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002544'] 409,29481453,Self-selected Rest Interval Improves Vertical Jump Postactivation Potentiation.,"ABSTRACT do Carmo, EC, De Souza, EO, Roschel, H, Kobal, R, Ramos, H, Gil, S, and Tricoli, V. Self-selected rest interval improves vertical jump postactivation potentiation. J Strength Cond Res 35(1): 91-96, 2021-This study compared the effects of self-selected rest interval (SSRI) and fixed rest interval (FRI) strategies on postactivation potentiation (PAP) in countermovement jump (CMJ) performance. Twelve strength-trained men (age: 25.4 ± 3.6 years; body mass: 78.8 ± 10.5 kg; height: 175 ± 7.0 cm; half-squat 1 repetition maximum: 188.7 ± 33.4 kg) performed 3 experimental conditions: (a) FRI: CMJ test; 4-minute rest interval; 5 repetition maximum (5RM) back squat; 4-minute rest interval; and CMJ test, (b) SSRI: CMJ test; 4-minute rest interval; 5RM back squat; SSRI; and CMJ test, and (c) control: CMJ test; 8-minute rest interval and CMJ test. In SSRI, subjects were instructed to rest until they felt fully recovered and able to exercise at maximal intensity based on the perceived readiness scale. Significant changes in pre-post CMJ performance were observed in the SSRI condition (38.2 ± 4.6 cm vs. 40.5 ± 4.4 cm; p = 0.08; confidence interval [CI]: 0.72-3.82 cm; effect size [ES] = 0.93). There were significant differences in post-CMJ performance when SSRI was compared with FRI (40.5 ± 4.4 cm vs. 37.7 ± 5.1 cm; p = 0.02; CI: 0.43-5.08; ES = 1.13) and control (40.5 ± 4.4 cm vs. 37.4 ± 5.7 cm; p = 0.01; CI: 0.66-5.61; ES = 1.35). The average rest interval length for the SSRI condition was 5:57 ± 2:44 min:sec (CI: 4:24-7:30). Our results suggest that the use of SSRI was an efficient and practical strategy to elicit PAP on CMJ height in strength-trained individuals.",2021,There were significant differences in post CMJ performance when SSRI was compared to FRI (40.5 ± 4.4 cm vs 37.7 ± 5.1 cm; p = 0.02; CI 0.43 to 5.08; ES = 1.13) and C (40.5 ± 4.4 cm vs. 37.4 ± 5.7 cm; p = 0.01; CI: 0.66 to 5.61; ES = 1.35).,"[""Twelve strength-trained male's (age: 25.4 ± 3.6 years; body mass: 78.8 ± 10.5 kg; height: 175 ± 7.0 cm; half-squat 1RM: 188.7 ± 33.4 kg) performed three experimental conditions: 1""]","['self-selected rest interval and fixed rest interval strategies', 'fixed rest interval (FRI: CMJ test; 4-min rest interval; 5RM back squat; 4-min rest interval; CMJ test), 2) self-selected rest interval (SSRI: CMJ test; 4-min rest interval; 5RM back squat; SSRI; CMJ test), and 3) control (C: CMJ test; 8-min rest interval; CMJ test']","['pre-post CMJ performance', 'average rest interval length', 'post CMJ performance', 'countermovement jump (CMJ) performance']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}]",,0.0631036,There were significant differences in post CMJ performance when SSRI was compared to FRI (40.5 ± 4.4 cm vs 37.7 ± 5.1 cm; p = 0.02; CI 0.43 to 5.08; ES = 1.13) and C (40.5 ± 4.4 cm vs. 37.4 ± 5.7 cm; p = 0.01; CI: 0.66 to 5.61; ES = 1.35).,"[{'ForeName': 'Everton C', 'Initials': 'EC', 'LastName': 'do Carmo', 'Affiliation': 'School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Eduardo O', 'Initials': 'EO', 'LastName': 'De Souza', 'Affiliation': 'Department of Health Sciences and Human Performance, The University of Tampa, Tampa, Florida; and.'}, {'ForeName': 'Hamilton', 'Initials': 'H', 'LastName': 'Roschel', 'Affiliation': 'School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ronaldo', 'Initials': 'R', 'LastName': 'Kobal', 'Affiliation': 'NAR-Nucleus of High Performance in Sport, São Paulo, Brazil.'}, {'ForeName': 'Henrique', 'Initials': 'H', 'LastName': 'Ramos', 'Affiliation': 'School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Saulo', 'Initials': 'S', 'LastName': 'Gil', 'Affiliation': 'School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Valmor', 'Initials': 'V', 'LastName': 'Tricoli', 'Affiliation': 'School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002519'] 410,32025341,Immunization with full-length Plasmodium falciparum merozoite surface protein 1 is safe and elicits functional cytophilic antibodies in a randomized first-in-human trial.,"A vaccine remains a priority in the global fight against malaria. Here, we report on a single-center, randomized, double-blind, placebo and adjuvant-controlled, dose escalation phase 1a safety and immunogenicity clinical trial of full-length Plasmodium falciparum merozoite surface protein 1 (MSP1) in combination with GLA-SE adjuvant. Thirty-two healthy volunteers were vaccinated at least three times with MSP1 plus adjuvant, adjuvant alone, or placebo (24:4:4) to evaluate the safety and immunogenicity. MSP1 was safe, well tolerated and immunogenic, with all vaccinees sero-converting independent of the dose. The MSP1-specific IgG and IgM titers persisted above levels found in malaria semi-immune humans for at least 6 months after the last immunization. The antibodies were variant- and strain-transcending and stimulated respiratory activity in granulocytes. Furthermore, full-length MSP1 induced memory T-cells. Our findings encourage challenge studies as the next step to evaluate the efficacy of full-length MSP1 as a vaccine candidate against falciparum malaria (EudraCT 2016-002463-33).",2020,"MSP1 was safe, well tolerated and immunogenic, with all vaccinees sero-converting independent of the dose.",['Thirty-two healthy volunteers'],"['placebo', 'MSP1 plus adjuvant, adjuvant alone, or placebo', 'GLA-SE adjuvant', 'MSP1']","['MSP1-specific IgG and IgM titers', 'safe, well tolerated and immunogenic', 'safety and immunogenicity']","[{'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0169904', 'cui_str': 'PFM-PSCP'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4276833', 'cui_str': 'glucopyranosyl lipid-A'}]","[{'cui': 'C0169904', 'cui_str': 'PFM-PSCP'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0020861', 'cui_str': 'IgM'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",32.0,0.114859,"MSP1 was safe, well tolerated and immunogenic, with all vaccinees sero-converting independent of the dose.","[{'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Blank', 'Affiliation': '1Klinische Pharmakologie und Pharmakoepidemiologie, Universitätsklinikum Heidelberg, Im Neuenheimer Feld 410, 69120 Heidelberg, Germany.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Fürle', 'Affiliation': '2Center of Infectious Diseases, Parasitology, Universitätsklinikum Heidelberg, Im Neuenheimer Feld 324, 69120 Heidelberg, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Jäschke', 'Affiliation': '2Center of Infectious Diseases, Parasitology, Universitätsklinikum Heidelberg, Im Neuenheimer Feld 324, 69120 Heidelberg, Germany.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Mikus', 'Affiliation': '1Klinische Pharmakologie und Pharmakoepidemiologie, Universitätsklinikum Heidelberg, Im Neuenheimer Feld 410, 69120 Heidelberg, Germany.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Lehmann', 'Affiliation': '3Koordinierungszentrum für Klinische Studien (KKS), Universitätsklinikum Heidelberg, Im Neuenheimer Feld 130.3, 69120 Heidelberg, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Hüsing', 'Affiliation': '3Koordinierungszentrum für Klinische Studien (KKS), Universitätsklinikum Heidelberg, Im Neuenheimer Feld 130.3, 69120 Heidelberg, Germany.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Heiss', 'Affiliation': 'PEPperPRINT GmbH, Rischerstrasse 12, 69123 Heidelberg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Giese', 'Affiliation': '5Institut für Immunologie, Universitätsklinikum Heidelberg und Deutsches Zentrum für Infektionsforschung (DZIF) Standort Heidelberg, Im Neuenheimer Feld 305, 69120 Heidelberg, Germany.'}, {'ForeName': 'Darrick', 'Initials': 'D', 'LastName': 'Carter', 'Affiliation': '6PAI Life Sciences, 1616 Eastlake Ave E, Suite 550, Seattle, WA 98102 USA.'}, {'ForeName': 'Ernst', 'Initials': 'E', 'LastName': 'Böhnlein', 'Affiliation': 'Sumaya Biotech GmbH & Co. KG, Im Neuenheimer Feld 582, 69120 Heidelberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lanzer', 'Affiliation': '2Center of Infectious Diseases, Parasitology, Universitätsklinikum Heidelberg, Im Neuenheimer Feld 324, 69120 Heidelberg, Germany.'}, {'ForeName': 'Walter E', 'Initials': 'WE', 'LastName': 'Haefeli', 'Affiliation': '1Klinische Pharmakologie und Pharmakoepidemiologie, Universitätsklinikum Heidelberg, Im Neuenheimer Feld 410, 69120 Heidelberg, Germany.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Bujard', 'Affiliation': 'Sumaya Biotech GmbH & Co. KG, Im Neuenheimer Feld 582, 69120 Heidelberg, Germany.'}]",NPJ vaccines,['10.1038/s41541-020-0160-2'] 411,31209595,Anticoagulants and cancer mortality in the Finnish randomized study of screening for prostate cancer.,"PURPOSE Anticoagulants may reduce mortality of cancer patients, though the evidence remains controversial. We studied the association between different anticoagulants and cancer death. METHODS All anticoagulant use during 1995-2015 was analyzed among 75,336 men in the Finnish Randomized Study of Screening for Prostate Cancer. Men with prevalent cancer were excluded. Multivariable Cox regression was performed to compare risk of death from any cancer and disease-specific death from 9 specific cancer types between (1) anticoagulant users overall and (2) warfarin users compared to anticoagulant non-users and (3) warfarin or (4) low-molecular-weight heparins (LMWH) compared to users of other anticoagulants. Medication use was analyzed as time-dependent variable to minimize immortal time bias. 1-, 2- and 3-year lag-time analyses were performed. RESULTS During a median follow-up of 17.2 years, a total of 27,233 men died of whom 8033 with cancer as the primary cause of death. In total, 32,628 men (43%) used anticoagulants. Any anticoagulant use was associated with an increased risk of cancer death (HR = 2.50, 95% CI 2.37-2.64) compared to non-users. Risk was similar independent of the amount, duration, or intensity of use. The risk increase was observed both among warfarin and LMWH users, although not as strong in warfarin users. Additionally, cancer-specific risks of death were similar to overall cancer mortality in all anticoagulant categories. CONCLUSION Our study does not support reduced cancer mortality among anticoagulant users. Future studies on drug use and cancer mortality should be adjusted for anticoagulants as they are associated with significantly higher risk of cancer death.",2019,"Any anticoagulant use was associated with an increased risk of cancer death (HR = 2.50, 95% CI 2.37-2.64) compared to non-users.","['32,628 men (43%) used anticoagulants', '75,336 men in the Finnish Randomized Study of Screening for Prostate Cancer', 'cancer patients', 'Men with prevalent cancer']",[],"['cancer mortality', 'death', 'overall cancer mortality', 'risk of cancer death', 'Anticoagulants and cancer mortality']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}]",32628.0,0.135541,"Any anticoagulant use was associated with an increased risk of cancer death (HR = 2.50, 95% CI 2.37-2.64) compared to non-users.","[{'ForeName': 'P T T', 'Initials': 'PTT', 'LastName': 'Kinnunen', 'Affiliation': 'School of Medicine, University of Tampere, Tampere, Finland. Kinnunen.Pete.T@student.uta.fi.'}, {'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'Murtola', 'Affiliation': 'School of Medicine, University of Tampere, Tampere, Finland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Talala', 'Affiliation': 'Finnish Cancer Registry, Helsinki, Finland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Taari', 'Affiliation': 'Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'T L J', 'Initials': 'TLJ', 'LastName': 'Tammela', 'Affiliation': 'School of Medicine, University of Tampere, Tampere, Finland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Auvinen', 'Affiliation': 'Department of Epidemiology, University of Tampere, Tampere, Finland.'}]",Cancer causes & control : CCC,['10.1007/s10552-019-01195-x'] 412,28787504,Effects of Improvisational Music Therapy vs Enhanced Standard Care on Symptom Severity Among Children With Autism Spectrum Disorder: The TIME-A Randomized Clinical Trial.,"Importance Music therapy may facilitate skills in areas affected by autism spectrum disorder (ASD), such as social interaction and communication. Objective To evaluate effects of improvisational music therapy on generalized social communication skills of children with ASD. Design, Setting, and Participants Assessor-blinded, randomized clinical trial, conducted in 9 countries and enrolling children aged 4 to 7 years with ASD. Children were recruited from November 2011 to November 2015, with follow-up between January 2012 and November 2016. Interventions Enhanced standard care (n = 182) vs enhanced standard care plus improvisational music therapy (n = 182), allocated in a 1:1 ratio. Enhanced standard care consisted of usual care as locally available plus parent counseling to discuss parents' concerns and provide information about ASD. In improvisational music therapy, trained music therapists sang or played music with each child, attuned and adapted to the child's focus of attention, to help children develop affect sharing and joint attention. Main Outcomes and Measures The primary outcome was symptom severity over 5 months, based on the Autism Diagnostic Observation Schedule (ADOS), social affect domain (range, 0-27; higher scores indicate greater severity; minimal clinically important difference, 1). Prespecified secondary outcomes included parent-rated social responsiveness. All outcomes were also assessed at 2 and 12 months. Results Among 364 participants randomized (mean age, 5.4 years; 83% boys), 314 (86%) completed the primary end point and 290 (80%) completed the last end point. Over 5 months, participants assigned to music therapy received a median of 19 music therapy, 3 parent counseling, and 36 other therapy sessions, compared with 3 parent counseling and 45 other therapy sessions for those assigned to enhanced standard care. From baseline to 5 months, mean ADOS social affect scores estimated by linear mixed-effects models decreased from 14.08 to 13.23 in the music therapy group and from 13.49 to 12.58 in the standard care group (mean difference, 0.06 [95% CI, -0.70 to 0.81]; P = .88), with no significant difference in improvement. Of 20 exploratory secondary outcomes, 17 showed no significant difference. Conclusions and Relevance Among children with autism spectrum disorder, improvisational music therapy, compared with enhanced standard care, resulted in no significant difference in symptom severity based on the ADOS social affect domain over 5 months. These findings do not support the use of improvisational music therapy for symptom reduction in children with autism spectrum disorder. Trial Registration isrctn.org Identifier: ISRCTN78923965.",2017,"Conclusions and Relevance Among children with autism spectrum disorder, improvisational music therapy, compared with enhanced standard care, resulted in no significant difference in symptom severity based on the ADOS social affect domain over 5 months.","['Spectrum Disorder', 'children with ASD', '9 countries and enrolling children aged 4 to 7 years with ASD', 'children with autism spectrum disorder', 'Children were recruited from November 2011 to November 2015, with follow-up between January 2012 and November 2016', '364 participants randomized (mean age, 5.4 years; 83% boys), 314 (86%) completed the primary end point and 290 (80%) completed the last end point', 'Children With Autism']","['improvisational music therapy', 'music therapy received a median of 19 music therapy, 3 parent counseling, and 36 other therapy sessions, compared with 3 parent counseling and 45 other therapy sessions', 'Interventions\n\n\nEnhanced standard care (n\u2009=\u2009182) vs enhanced standard care plus improvisational music therapy', 'Improvisational Music Therapy', 'Music therapy', ""improvisational music therapy, trained music therapists sang or played music with each child, attuned and adapted to the child's focus of attention""]","['mean ADOS social affect scores', 'parent-rated social responsiveness', 'generalized social communication skills', 'symptom severity over 5 months, based on the Autism Diagnostic Observation Schedule (ADOS), social affect domain', 'Symptom Severity']","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}]","[{'cui': 'C0026868', 'cui_str': 'Music Therapy'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0586937', 'cui_str': 'Music therapist (occupation)'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C3541951', 'cui_str': 'Domain'}]",364.0,0.0868879,"Conclusions and Relevance Among children with autism spectrum disorder, improvisational music therapy, compared with enhanced standard care, resulted in no significant difference in symptom severity based on the ADOS social affect domain over 5 months.","[{'ForeName': 'Lucja', 'Initials': 'L', 'LastName': 'Bieleninik', 'Affiliation': 'GAMUT-The Grieg Academy Music Therapy Research Centre, Uni Research Health, Uni Research, Bergen, Norway.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Geretsegger', 'Affiliation': 'GAMUT-The Grieg Academy Music Therapy Research Centre, Uni Research Health, Uni Research, Bergen, Norway.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Mössler', 'Affiliation': 'GAMUT-The Grieg Academy Music Therapy Research Centre, Uni Research Health, Uni Research, Bergen, Norway.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Assmus', 'Affiliation': 'GAMUT-The Grieg Academy Music Therapy Research Centre, Uni Research Health, Uni Research, Bergen, Norway.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Thompson', 'Affiliation': 'Melbourne Conservatorium of Music, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Gattino', 'Affiliation': 'Department of Communication and Psychology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Cochavit', 'Initials': 'C', 'LastName': 'Elefant', 'Affiliation': 'School for Creative Arts Therapies, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Gottfried', 'Affiliation': 'Music Therapy Program, David-Yelin College, Jerusalem, Israel.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Igliozzi', 'Affiliation': 'IRCCS Stella Maris Foundation, Pisa, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Muratori', 'Affiliation': 'IRCCS Stella Maris Foundation, Pisa, Italy.'}, {'ForeName': 'Ferdinando', 'Initials': 'F', 'LastName': 'Suvini', 'Affiliation': 'IRCCS Stella Maris Foundation, Pisa, Italy.'}, {'ForeName': 'Jinah', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Jeonju University, Jeonju, South Korea.'}, {'ForeName': 'Mike J', 'Initials': 'MJ', 'LastName': 'Crawford', 'Affiliation': 'Centre for Psychiatry, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Odell-Miller', 'Affiliation': 'Anglia Ruskin University, Cambridge, United Kingdom.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Oldfield', 'Affiliation': 'Anglia Ruskin University, Cambridge, United Kingdom.'}, {'ForeName': 'Órla', 'Initials': 'Ó', 'LastName': 'Casey', 'Affiliation': 'Anglia Ruskin University, Cambridge, United Kingdom.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Finnemann', 'Affiliation': 'Anglia Ruskin University, Cambridge, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Carpente', 'Affiliation': 'Rebecca Center for Music Therapy at Molloy College, Rockville Centre, New York.'}, {'ForeName': 'A-La', 'Initials': 'AL', 'LastName': 'Park', 'Affiliation': 'Personal Social Services Research Unit, LSE Health and Social Care, The London School of Economics and Political Science, London, United Kingdom.'}, {'ForeName': 'Enzo', 'Initials': 'E', 'LastName': 'Grossi', 'Affiliation': 'Villa Santa Maria Institute, Tavernerio, Italy.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gold', 'Affiliation': 'GAMUT-The Grieg Academy Music Therapy Research Centre, Uni Research Health, Uni Research, Bergen, Norway.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2017.9478'] 413,28746244,The Effect of Unicycle Riding Course on Trunk Strength and Trunk Stability Functions in Children.,"Kocjan, A and Sarabon, N. The effect of unicycle riding course on trunk strength and trunk stability functions in children. J Strength Cond Res 34(12): 3560-3568, 2020-The aim of the study was to assess the effect of unicycling on trunk strength and timing of automatic stability actions of the selected trunk muscles (multifidus, obliquus externus, and erector spine). Twenty healthy 12-year-old children (12 boys, 8 girls; age 12.1 ± 0.2 years; body height 1.57 ± 0.05 m; body mass 52.8 ± 10.6 kg) were assigned to experimental and control group. Experimental group performed a supervised 12-session course of unicycling. Trunk strength was measured with a multipurpose diagnostic machine in frontal and sagittal planes in standing position. Trunk reflex responses and anticipatory actions were assessed through unexpected loading over the hands and rapid shoulder flexion, respectively. After the intervention, strength increased significantly (p < 0.01) in the experimental group in all analyzed positions. A significant interaction effect was observed during trunk extension (p < 0.01) and lateral flexion exertions (p < 0.03). Postural reflex latency improved significantly (p < 0.001) in the experimental group with a significant interaction effect in all analyzed muscles (p < 0.001). Anticipatory postural adaptations improved significantly (p ≤ 0.05) in multifidus and obliquus externus of the experimental group only. Unicycling proved to be an effective and funny tool to develop proximal stability and strength, which prevents low back pain and improves the efficiency of energy transfer between body segments. To improve the efficiency of physical education classes, unicycling should be considered a useful tool to increase trunk strength and stability among prepubertal children.",2020,"Anticipatory postural adaptations improved significantly (p < 0.05) in multifidus and obliquus externus of the experimental group only. ","['children', 'prepubertal children', 'Twenty healthy 12-year-old children (12 boys, 8 girls; age 12.1 ± 0.2 yrs; body height 1.57 ± 0.05 m; body mass 52.8 ± 10.6 kg']",['unicycle riding course'],"['Anticipatory postural adaptations', 'Trunk reflex responses and anticipatory actions', 'strength', 'Postural reflex latency', 'Trunk strength', 'trunk strength and trunk stability functions', 'lateral flexion exertions']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0005890', 'cui_str': 'Body Height'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]","[{'cui': 'C0336818', 'cui_str': 'Unicycle, device (physical object)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}]","[{'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0234154', 'cui_str': 'Postural reflex (observable entity)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439791', 'cui_str': 'Lateral flexion, function (observable entity)'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}]",20.0,0.0307376,"Anticipatory postural adaptations improved significantly (p < 0.05) in multifidus and obliquus externus of the experimental group only. ","[{'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Kocjan', 'Affiliation': 'University of Primorska, Faculty of Education, Koper, Slovenia.'}, {'ForeName': 'Nejc', 'Initials': 'N', 'LastName': 'Sarabon', 'Affiliation': 'Department of Health Study, University of Primorska, Andrej Marusic Institute, Koper, Slovenia; and.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002151'] 414,29278576,Electrical Stimulation of the Antagonist Muscle During Cycling Exercise Interval Training Improves Oxygen Uptake and Muscle Strength.,"ABSTRACT Hashida, R, Takano, Y, Matsuse, H, Kudo, M, Bekki, M, Omoto, M, Nago, T, Kawaguchi, T, Torimura, T, and Shiba, N. Electrical stimulation of the antagonist muscle during cycling exercise interval training improves oxygen uptake and muscle strength. J Strength Cond Res 35(1): 111-117, 2021-A hybrid training system (HTS) is a resistance exercise method that combines voluntary concentric muscle contractions and electrically stimulated eccentric muscle contractions. We devised an exercise technique using HTS on cycle ergometer (HCE). The purpose of this study was to compare cardiorespiratory function and muscle strength when cycling exercise is combined with electrical stimulation over an extended period. Twenty-nine healthy young men were divided into an HCE group (n = 14) and a volitional cycle ergometer (VCE alone) group (n = 15). All subjects performed 30-minute cycling exercise interval training sessions 3 times a week for 6 weeks. The V̇o2peak of both groups significantly increased compared with the pretraining period (HCE group: from 31.3 ± 4.4 [ml·kg-1·min-1] pretraining to 37.6 ± 6.7 [ml·kg-1·min-1] post-training [p = 0.0024] and VCE group: from 34.0 ± 7.1 [ml·kg-1·min-1] pretraining to 38.4 ± 8.2 [ml·kg-1·min-1] [p = 0.0057]). After the training, there was no significant difference of changes in V̇o2peak between the HCE and the VCE groups (p = 0.7107). In the VCE group, the maximal isokinetic torque of knee extension (60°·s-1) post-training did not significantly increase compared with the pretraining period (VCE group: from 2.4 ± 0.5 [N·m·kg-1] pretraining to 2.5 ± 0.4 [N·m·kg-1] [p = 0.4543]). By contrast, in the HCE group, the maximal isokinetic torque of knee extension (60°·s-1) post-training significantly increased compared with pretraining period (HCE group: from 2.5 ± 0.3 [N·m·kg-1] pretraining to 2.8 ± 0.3 [N·m·kg-1] [p < 0.0001]). The change in knee extension torque was significantly greater for the HCE group than for the VCE group (p = 0.0307). In conclusion, cardiopulmonary function and knee extension strength were improved by the use of HCE.",2021,"After the training, there was no significant difference of changes in VO2peak between the HCE and the VCE groups (P=0.7107).",['Twenty-nine healthy young men'],"['VCE group (volitional cycle ergometer alone', 'VCE', 'hybrid training system (HTS', 'Cycling Exercise Interval Training', 'exercise technique using HTS', 'HCE']","['changes in VO2peak', 'maximal isokinetic torque of knee extension', 'cardiopulmonary function and knee extension strength', 'Oxygen Uptake and Muscle Strength', 'knee extension torque']","[{'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0062144', 'cui_str': 'HCE'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",,0.0170528,"After the training, there was no significant difference of changes in VO2peak between the HCE and the VCE groups (P=0.7107).","[{'ForeName': 'Ryuki', 'Initials': 'R', 'LastName': 'Hashida', 'Affiliation': 'Division of Rehabilitation, Kurume University Hospital, Kurume, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Takano', 'Affiliation': 'Department of Physical Therapy, School of Health Sciences, International University Health and Welfare, Enokizu, Okawa, Japan; and.'}, {'ForeName': 'Hiroo', 'Initials': 'H', 'LastName': 'Matsuse', 'Affiliation': 'Division of Rehabilitation, Kurume University Hospital, Kurume, Japan.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': 'Division of Rehabilitation, Kurume University Hospital, Kurume, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Bekki', 'Affiliation': 'Division of Rehabilitation, Kurume University Hospital, Kurume, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Omoto', 'Affiliation': 'Division of Rehabilitation, Kurume University Hospital, Kurume, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Nago', 'Affiliation': 'Division of Rehabilitation, Kurume University Hospital, Kurume, Japan.'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Kawaguchi', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Japan.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Torimura', 'Affiliation': 'Department of Physical Therapy, School of Health Sciences, International University Health and Welfare, Enokizu, Okawa, Japan; and.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Shiba', 'Affiliation': 'Division of Rehabilitation, Kurume University Hospital, Kurume, Japan.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002393'] 415,29239988,Effect of Boards in Small-Sided Street Soccer Games on Movement Pattern and Physiological Response in Recreationally Active Young Men.,"Randers, MB, Brix, J, Hagman, M, Nielsen, JJ, and Krustrup, P. Effect of boards in small-sided street soccer games on movement pattern and physiological response in recreationally active young men. J Strength Cond Res 34(12): 3530-3537, 2020-This study investigated whether street soccer might be proposed as an alternative to recreational small-sided games on grass as a health-enhancing activity and, specifically, the effects of the boards surrounding the pitch. Eleven recreationally active young men (28.4 ± 4.2 SD years, 19.9 ± 4.2% body fat, and 47.7 ± 6.0 ml·min·kg), after familiarization, completed one to 2 sessions of 20 × 13-m 3v3 street soccer games with boards (WBs) and one to 2 sessions without boards (WOBs) in a randomized order. Movement pattern was measured using global positioning system, and heart rate recordings, blood sampling, and rating of perceived exertion (RPE) scales were used to evaluate exercise intensity and physiological strain. Total number of accelerations (19%) and player load (18%) were higher (p ≤ 0.005) in WB than in WOB, whereas total distance covered (12%), high-speed running (59%), and peak speed (11%) were lower (p ≤ 0.003) in WB than in WOB. Moreover, HRmean was higher in WB than in WOB (85.7 ± 5.4 vs. 81.3 ± 8.2% HRmax, p = 0.012, ES = 0.64), whereas time with HR > 90% HRmax did not differ between WB and WOB (42 ± 34 vs. 32 ± 30%, p = 0.243, ES = 0.32). Plasma ammonia increased more in WB than in WOB, with no differences found in mean and peak blood lactate. Rating of perceived exertion was higher after WB than after WOB (7.1 ± 1.0 vs. 5.5 ± 1.2, p < 0.001, ES = 1.39). In conclusion, intensity was sufficiently high in both game formats to expect short- and long-term health improvements as a result of regular participation. Boards affected movement pattern and physiological demands, producing higher number of accelerations, player load, average heart rate, plasma ammonia, and RPE but lower total distance, number of intense runs, and peak speed.",2020,"Total number of accelerations (19%) and Player Load (18%) were higher (p < 0.05) in WB than in WOB, whereas total distance covered (12%), high-speed running (59%) and peak speed (11%) were lower (p < 0.05) in WB than in WOB.","['Eleven recreationally active young males (28.4±4.2 (±SD) yrs, 19.9±4.2% body fat, 47.7±6.0 mlminkg), after familiarization, completed one to two sessions of 20x13-m 3v3 street soccer games with', 'Recreationally Active Young Men']",['boards (WB) and one to two sessions without boards (WOB'],"['time with HR>90%HRmax', 'total distance', 'peak speed', 'Player Load', 'mean and peak blood lactate', 'Movement Pattern and Physiological Response', 'Total number of accelerations', 'Plasma ammonia', 'high-speed running', 'number of accelerations, Player Load, average heart rate, plasma ammonia, and rating of perceived exertion, but lower total distance, number of intense runs and peak speed', 'GPS and heart rate recordings, blood sampling and RPE scales', 'RPE']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442658', 'cui_str': 'Street (environment)'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]",[],"[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0002607', 'cui_str': 'Ammonia'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0005834', 'cui_str': 'Blood Specimen Collection'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0222045'}]",,0.0643282,"Total number of accelerations (19%) and Player Load (18%) were higher (p < 0.05) in WB than in WOB, whereas total distance covered (12%), high-speed running (59%) and peak speed (11%) were lower (p < 0.05) in WB than in WOB.","[{'ForeName': 'Morten B', 'Initials': 'MB', 'LastName': 'Randers', 'Affiliation': 'Copenhagen Center for Team Sport and Health, Department of Nutrition, Exercise and Sports, Section of Integrative Physiology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Brix', 'Affiliation': 'Copenhagen Center for Team Sport and Health, Department of Nutrition, Exercise and Sports, Section of Integrative Physiology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hagman', 'Affiliation': 'Copenhagen Center for Team Sport and Health, Department of Nutrition, Exercise and Sports, Section of Integrative Physiology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Nielsen', 'Affiliation': 'Copenhagen Center for Team Sport and Health, Department of Nutrition, Exercise and Sports, Section of Integrative Physiology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Krustrup', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Sport and Health Sciences Cluster (SHSC), University of Southern Denmark, Odense, Denmark; and.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002401'] 416,29136682,Exploring the cancer caregiver's journey through web-based Meaning-Centered Psychotherapy.,"OBJECTIVE Psychosocial interventions are historically underutilized by cancer caregivers, but support programs delivered flexibly over the Internet address multiple barriers to care. We adapted Meaning-Centered Psychotherapy for cancer caregivers, an in-person psychotherapeutic intervention intended to augment caregivers' sense of meaning and purpose and ameliorate burden, for delivery in a self-administered web-based program, the Care for the Cancer Caregiver (CCC) Workshop. The present study evaluated the feasibility, acceptability, and preliminary effects of this program. METHODS Eighty-four caregivers were randomized to the CCC Workshop or waitlist control arm. Quantitative assessments of meaning, burden, anxiety, depression, benefit finding, and spiritual well-being were conducted preintervention (T1), within 2-weeks postintervention (T2), and 2- to 3-month follow-up (T3). In-depth semistructured interviews were conducted with a subset of participants. RESULTS Forty-two caregivers were randomized to the CCC Workshop. Attrition was moderate at T2 and T3, with caregiver burden and bereavement as key causes of drop-out. At T2 and T3, some observed mean change scores and effect sizes were consistent with hypothesized trends (eg, meaning in caregiving, benefit finding, and depressive symptomatology), though no pre-post significant differences emerged between groups. However, a longitudinal mixed-effects model found significant differential increases in benefit finding in favor of the CCC arm. CONCLUSIONS The CCC Workshop was feasible and acceptable. Based on effect sizes reported here, a larger study will likely establish the efficacy of the CCC Workshop, which has the potential to address unmet needs of caregivers who underutilize in-person supportive care services.",2018,"Quantitative assessments of meaning, burden, anxiety, depression, benefit finding, and spiritual well-being were conducted preintervention (T1), within 2-weeks postintervention (T2), and 2- to 3-month follow-up (T3).","['Forty-two caregivers', 'Eighty-four caregivers']",['CCC Workshop or waitlist control arm'],"['Quantitative assessments of meaning, burden, anxiety, depression, benefit finding, and spiritual well-being', 'meaning in caregiving, benefit finding, and depressive symptomatology']","[{'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C4319623', 'cui_str': '84 (qualifier value)'}]","[{'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",84.0,0.0869347,"Quantitative assessments of meaning, burden, anxiety, depression, benefit finding, and spiritual well-being were conducted preintervention (T1), within 2-weeks postintervention (T2), and 2- to 3-month follow-up (T3).","[{'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Applebaum', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'Buda', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Schofield', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Farberov', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'N D', 'Initials': 'ND', 'LastName': 'Teitelbaum', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Evans', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Cowens-Alvarado', 'Affiliation': 'American Cancer Society, Atlanta, GA, USA.'}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Cannady', 'Affiliation': 'American Cancer Society, Atlanta, GA, USA.'}]",Psycho-oncology,['10.1002/pon.4583'] 417,28902112,Efficacy of Repeated Cold Water Immersion on Recovery After a Simulated Rugby Union Protocol.,"Barber, S, Pattison, J, Brown, F, and Hill, J. Efficacy of repeated cold water immersion on recovery after a simulated rugby union protocol. J Strength Cond Res 34(12): 3523-3529, 2020-Training and athletic competition frequently results in exercise-induced muscle damage (EIMD). The purpose of this study was to investigate the efficacy of repeated cold water immersion (CWI) on recovery after a simulated rugby union match. Sixteen male, club-level rugby players were matched for body mass and randomly assigned to either a CWI group or control (CON) group. After the simulated rugby match, the CWI group underwent 2 × 5-minute immersions at a temperature of 10° C separated by 2.5 minutes seated at room temperature, whereas the CON group remained seated for 15 minutes. Creatine kinase (CK), perceived muscle soreness, counter movement jump (CMJ), and maximal voluntary isometric contraction (MVIC) of the knee extensors were measured pre-exercise, postexercise, 24 and 48 hours after exercise. Large effect sizes were observed for muscle soreness at 24 and 48 hours after exercise with lower soreness values observed in the CWI group. Large effect sizes were observed for CMJ at all time points and at 24 and 48 hours post for MVIC with improved recovery of muscle function observed in the CWI group compared with the CON group. Last, a moderate effect size was observed for CK immediately after exercise, followed by large effect sizes at 24 and 48 hours after exercise, with CK concentration blunted in the CWI group. Overall, these findings provide some support for the use of CWI to enhance recovery from EIMD after a simulated rugby union match.",2020,"Creatine kinase (CK), perceived muscle soreness, counter movement jump (CMJ) and maximal voluntary isometric contraction (MVIC) of the knee extensors were measured pre-exercise, post-exercise, 24 h and 48 h following exercise.","['Sixteen male, club level rugby players']","['CWI group or control (CON', 'repeated cold water immersion (CWI', 'CON', 'Repeated Cold Water Immersion']","['CK concentration blunted', 'muscle damage (EIMD', 'muscle soreness', 'Creatine kinase (CK), perceived muscle soreness, counter movement jump (CMJ) and maximal voluntary isometric contraction (MVIC) of the knee extensors', 'recovery of muscle function']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C4708833', 'cui_str': 'Cold water'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C0677601', 'cui_str': 'Counter (physical object)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0022205', 'cui_str': 'Isometric Contraction'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231484', 'cui_str': 'Muscular activity'}]",16.0,0.0603736,"Creatine kinase (CK), perceived muscle soreness, counter movement jump (CMJ) and maximal voluntary isometric contraction (MVIC) of the knee extensors were measured pre-exercise, post-exercise, 24 h and 48 h following exercise.","[{'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Barber', 'Affiliation': ""School of Sport, Health and Applied Science, St. Mary's University, Twickenham, United Kingdom.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Pattison', 'Affiliation': ''}, {'ForeName': 'Freddy', 'Initials': 'F', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Hill', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002239'] 418,29481448,Reduced Electromyographic Fatigue Threshold After Performing a Cognitive Fatiguing Task.,"ABSTRACT Ferris, JR, Tomlinson, MA, Ward, TN, Pepin, ME, and Malek, MH. Reduced electromyographic fatigue threshold after performing a cognitive fatiguing task. J Strength Cond Res 35(1): 267-274, 2021-Cognitive fatigue tasks performed before exercise may reduce exercise capacity. The electromyographic fatigue threshold (EMGFT) is the highest exercise intensity that can be maintained without significant increase in the electromyography (EMG) amplitude vs. time relationship. To date, no studies have examined the effect of cognitive fatigue on the estimation of the EMGFT. The purpose of this study, therefore, was to determine whether cognitive fatigue before performing exercise reduces the estimated EMGFT. Eight healthy college-aged men were recruited from a university student population and visited the laboratory on multiple occasions. In a randomized order, subjects performed either the cognitive fatigue task (AX continuous performance test) for 60 minutes on one visit (experimental condition) or watched a video on trains for 60 minutes on the other visit (control condition). After each condition, subjects performed the incremental single-leg knee-extensor ergometry test while the EMG amplitude was recorded from the rectus femoris muscle and heart rate was monitored throughout. Thereafter, the EMGFT was calculated for each subject for each visit and compared using paired samples t-test. For exercise outcomes, there were no significant mean differences for maximal power output between the 2 conditions (control: 51 ± 5 vs. fatigue: 50 ± 3 W), but there was a significant decrease in EMGFT between the 2 conditions (control: 31 ± 3 vs. fatigue: 24 ± 2 W; p = 0.013). Moreover, maximal heart rate was significantly different between the 2 conditions (control: 151 ± 5 vs. fatigue: 132 ± 6; p = 0.027). These results suggest that performing the cognitive fatiguing task reduces the EMGFT with a corresponding reduction in maximal heart rate response.",2021,These results suggest that performing the cognitive fatiguing task reduces the EMGFT with a corresponding reduction in maximal heart rate response.,['Eight healthy college-aged men were recruited from a university student population and visited the laboratory on multiple occasions'],['cognitive fatigue task (AX Continuous Performance Test; AX-CPT'],"['electromyographic fatigue threshold (EMGFT', 'EMGFT', 'maximal heart rate response', 'maximal power output', 'maximal heart rate', 'exercise capacity', 'Electromyographic Fatigue']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4329232', 'cui_str': 'Continuous Performance Task'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C1997337', 'cui_str': 'Speed of heart rate response'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",8.0,0.0211316,These results suggest that performing the cognitive fatiguing task reduces the EMGFT with a corresponding reduction in maximal heart rate response.,"[{'ForeName': 'Justine R', 'Initials': 'JR', 'LastName': 'Ferris', 'Affiliation': 'Physical Therapy Program, Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University, Detroit, Michigan; and.'}, {'ForeName': 'Mary A', 'Initials': 'MA', 'LastName': 'Tomlinson', 'Affiliation': 'Physical Therapy Program, Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University, Detroit, Michigan; and.'}, {'ForeName': 'Tayler N', 'Initials': 'TN', 'LastName': 'Ward', 'Affiliation': 'Physical Therapy Program, Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University, Detroit, Michigan; and.'}, {'ForeName': 'Marie E', 'Initials': 'ME', 'LastName': 'Pepin', 'Affiliation': 'Physical Therapy Program, Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University, Detroit, Michigan; and.'}, {'ForeName': 'Moh H', 'Initials': 'MH', 'LastName': 'Malek', 'Affiliation': 'Physical Therapy Program, Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University, Detroit, Michigan; and.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002490'] 419,31607603,"The effect of increased inoculum on oral rotavirus vaccine take among infants in Dhaka, Bangladesh: A double-blind, parallel group, randomized, controlled trial.","BACKGROUND Oral, live-attenuated rotavirus vaccines suffer from impaired immunogenicity and efficacy in low-income countries. Increasing the inoculum of vaccine might improve vaccine response, but this approach has been inadequately explored in low-income countries. METHODS We performed a double-blind, parallel group, randomized controlled trial from June 2017 through June 2018 in the urban Mirpur slum of Dhaka, Bangladesh to compare vaccine take (primary outcome) among healthy infants randomized to receive either the standard dose or double the standard dose of oral Rotarix (GlaxoSmithKline) vaccine at 6 and 10 weeks of life. Infants with congenital malformations, birth or enrollment weight <2000 gm, known immunocompromising condition, enrollment in another vaccine trial, or other household member enrolled in the study were excluded. Infants were randomized using random permuted blocks. Vaccine take was defined as detection of post-vaccination fecal vaccine shedding by real-time reverse transcription polymerase chain reaction with sequence confirmation or plasma rotavirus-specific immunoglobulin A (RV-IgA) seroconversion 4 weeks following the second dose. RESULTS 220 infants were enrolled and randomized (110 per group). 97 standard-dose and 92 high-dose infants completed the study per-protocol. For the primary outcome, no significant difference was observed between groups: vaccine take occurred in 62 (67%) high-dose infants versus 69 (71%) standard-dose infants (RR 0.92, 95% CI 0.67-1.24). However, in post-hoc analysis, children with confirmed vaccine replication had significantly increased RV-IgA responses, independent of the intervention. No significant adverse events related to study participation were detected. CONCLUSIONS Administration of double the standard dose of an oral, live-attenuated rotavirus vaccine (Rotarix) did not improve vaccine take among infants in urban Dhaka, Bangladesh. However, improved immunogenicity in children with vaccine replication irrespective of initial inoculum provides further evidence for the need to promote in-host replication and improved gut health to improve oral vaccine response in low-income settings. ClinicalTrials.gov: NCT02992197.",2020,"For the primary outcome, no significant difference was observed between groups: vaccine take occurred in 62 (67%) high-dose infants versus 69 (71%) standard-dose infants (RR 0.92, 95% CI 0.67-1.24).","['infants in urban Dhaka, Bangladesh', 'June 2017 through June 2018 in the urban Mirpur slum of Dhaka, Bangladesh to compare vaccine take (primary outcome) among healthy infants', 'Infants with congenital malformations, birth or enrollment weight <2000\u202fgm, known immunocompromising condition, enrollment in another vaccine trial, or other household member enrolled in the study were excluded', '220 infants were enrolled and randomized (110 per group', 'infants in Dhaka, Bangladesh']","['standard dose or double the standard dose of oral Rotarix (GlaxoSmithKline) vaccine', 'live-attenuated rotavirus vaccine (Rotarix']","['vaccine take', 'RV-IgA responses']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0037345', 'cui_str': 'Slums'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0000768', 'cui_str': 'Birth Defects'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0085393', 'cui_str': 'Immunosuppressed Host'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1528012', 'cui_str': 'Rotarix'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus Vaccines'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}]",220.0,0.749609,"For the primary outcome, no significant difference was observed between groups: vaccine take occurred in 62 (67%) high-dose infants versus 69 (71%) standard-dose infants (RR 0.92, 95% CI 0.67-1.24).","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Lee', 'Affiliation': 'UVM Vaccine Testing Center and Department of Pediatrics, University of Vermont Larner College of Medicine, Burlington, VT 05405, USA. Electronic address: blee7@uvm.edu.'}, {'ForeName': 'Dorothy M', 'Initials': 'DM', 'LastName': 'Dickson', 'Affiliation': 'UVM Vaccine Testing Center and Department of Microbiology and Molecular Genetics, University of Vermont Larner College of Medicine, Burlington, VT 05405, USA.'}, {'ForeName': 'Masud', 'Initials': 'M', 'LastName': 'Alam', 'Affiliation': 'Centre for Vaccine Science and Parasitology Lab, International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka 1212, Bangladesh.'}, {'ForeName': 'Sajia', 'Initials': 'S', 'LastName': 'Afreen', 'Affiliation': 'Centre for Vaccine Science and Parasitology Lab, International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka 1212, Bangladesh.'}, {'ForeName': 'Abdul', 'Initials': 'A', 'LastName': 'Kader', 'Affiliation': 'Centre for Vaccine Science and Parasitology Lab, International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka 1212, Bangladesh.'}, {'ForeName': 'Faria', 'Initials': 'F', 'LastName': 'Afrin', 'Affiliation': 'Centre for Vaccine Science and Parasitology Lab, International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka 1212, Bangladesh.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Ferdousi', 'Affiliation': 'Centre for Vaccine Science and Parasitology Lab, International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka 1212, Bangladesh.'}, {'ForeName': 'Christina F', 'Initials': 'CF', 'LastName': 'Damon', 'Affiliation': 'UVM Vaccine Testing Center and Department of Microbiology and Molecular Genetics, University of Vermont Larner College of Medicine, Burlington, VT 05405, USA.'}, {'ForeName': 'Soyeon K', 'Initials': 'SK', 'LastName': 'Gullickson', 'Affiliation': 'UVM Vaccine Testing Center and Department of Microbiology and Molecular Genetics, University of Vermont Larner College of Medicine, Burlington, VT 05405, USA.'}, {'ForeName': 'Monica M', 'Initials': 'MM', 'LastName': 'McNeal', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA; Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Bak', 'Affiliation': 'UVM Vaccine Testing Center and Department of Microbiology and Molecular Genetics, University of Vermont Larner College of Medicine, Burlington, VT 05405, USA.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Tolba', 'Affiliation': 'UVM Vaccine Testing Center and Department of Microbiology and Molecular Genetics, University of Vermont Larner College of Medicine, Burlington, VT 05405, USA.'}, {'ForeName': 'Marya P', 'Initials': 'MP', 'LastName': 'Carmolli', 'Affiliation': 'UVM Vaccine Testing Center and Department of Microbiology and Molecular Genetics, University of Vermont Larner College of Medicine, Burlington, VT 05405, USA.'}, {'ForeName': 'Mami', 'Initials': 'M', 'LastName': 'Taniuchi', 'Affiliation': 'Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia, Charlottesville, VA 22908, USA.'}, {'ForeName': 'Rashidul', 'Initials': 'R', 'LastName': 'Haque', 'Affiliation': 'Centre for Vaccine Science and Parasitology Lab, International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka 1212, Bangladesh.'}, {'ForeName': 'Beth D', 'Initials': 'BD', 'LastName': 'Kirkpatrick', 'Affiliation': 'UVM Vaccine Testing Center and Department of Microbiology and Molecular Genetics, University of Vermont Larner College of Medicine, Burlington, VT 05405, USA.'}]",Vaccine,['10.1016/j.vaccine.2019.09.088'] 420,28826616,"Updated analysis of CALGB (Alliance) 100104 assessing lenalidomide versus placebo maintenance after single autologous stem-cell transplantation for multiple myeloma: a randomised, double-blind, phase 3 trial.","BACKGROUND In the CALGB (Alliance) 100104 study, lenalidomide versus placebo after autologous stem-cell transplantation (ASCT) was investigated for patients with newly diagnosed myeloma. That study showed improved time to progression and overall survival and an increase in second primary malignancies for lenalidomide at a median follow-up of 34 months. Here we report an updated intention-to-treat analysis of CALGB (Alliance) 100104 at a median follow-up of 91 months. METHODS Patients were eligible for this randomised, double-blind, placebo-controlled, phase 3 trial if they had symptomatic disease requiring treatment; had received, at most, two induction regimens; and had achieved stable disease or better in the first 100 days after ASCT. We randomly assigned patients to either lenalidomide or placebo groups using permuted block randomisation, with a fixed block size of six. Randomisation was stratified by three factors: normal or elevated β2 microglobulin concentration at registration (≤2·5 mg/L vs >2·5 mg/L), previous use or non-use of thalidomide during induction therapy, and previous use or non-use of lenalidomide during induction therapy. The starting dose was two capsules (10 mg) per day, escalated to three capsules (15 mg) per day after 3 months. The primary endpoint was time to progression (time of progressive disease or death from any cause), with intention-to-treat analysis. This study is registered with ClinicalTrials.gov, identifier NCT00114101. New patients are no longer being recruited, but some patients remain on treatment and in follow-up. FINDINGS Between April 14, 2005, and July 2, 2009, 460 patients were randomly assigned to receive either lenalidomide (n=231) or placebo (n=229). After three interim analyses, the study was unblinded at a median follow-up of 18 months, at which point 86 (67%) of 128 patients without progressive disease in the placebo group chose to cross over to the lenalidomide group. The median follow-up for the updated survival analysis, as of Oct 19, 2016, was 91 months (IQR 83·6-103·1). The median time to progression was 57·3 months (95% CI 44·2-73·3) for the lenalidomide group and 28·9 months (23·0-36·3) for the placebo group (hazard ratio 0·57, 95% CI 0·46-0·71; p<0·0001). The most common grade 3-4 adverse events were neutropenia (116 [50%] patients in the lenalidomide group and 41 [18%] patients in the placebo group) and thrombocytopenia (34 [15%] patients in the lenalidomide group and 12 [5%] patients in the placebo group). 18 (8%) haematological and 14 (6%) solid tumour second primary malignancies were diagnosed after randomisation and before disease progression in the lenalidomide group, compared with three (1%) haematological and nine (4%) solid tumour second primary malignancies in the placebo group. Three haematological and five solid tumour second primary malignancies in the placebo group were in the crossover subgroup. INTERPRETATION Despite an increase in haematological adverse events and second primary malignancies, lenalidomide maintenance therapy after ASCT significantly improved time to progression and could be considered a standard of care. FUNDING The National Cancer Institute.",2017,"The median time to progression was 57·3 months (95% CI 44·2-73·3) for the lenalidomide group and 28·9 months (23·0-36·3) for the placebo group (hazard ratio 0·57, 95% CI 0·46-0·71; p<0·0001).","['460 patients', 'patients in the lenalidomide group and 41', '128 patients without progressive disease in the', 'Patients were eligible', 'patients with newly diagnosed myeloma', 'Between April 14, 2005, and July 2, 2009', 'multiple myeloma']","['placebo', 'thalidomide', 'lenalidomide or placebo', 'lenalidomide versus placebo', 'autologous stem-cell transplantation (ASCT', 'lenalidomide', 'placebo maintenance after single autologous stem-cell transplantation']","['median time to progression', 'haematological adverse events', 'time to progression (time of progressive disease or death from any cause), with intention-to-treat analysis', 'neutropenia', 'time to progression and overall survival', 'thrombocytopenia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}]",460.0,0.75969,"The median time to progression was 57·3 months (95% CI 44·2-73·3) for the lenalidomide group and 28·9 months (23·0-36·3) for the placebo group (hazard ratio 0·57, 95% CI 0·46-0·71; p<0·0001).","[{'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Holstein', 'Affiliation': 'University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Sin-Ho', 'Initials': 'SH', 'LastName': 'Jung', 'Affiliation': 'Alliance Statistics and Data Center, Duke University, Durham, NC, USA.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Richardson', 'Affiliation': 'Dana-Farber/Partners CancerCare, Boston, MA, USA.'}, {'ForeName': 'Craig C', 'Initials': 'CC', 'LastName': 'Hofmeister', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, OH, USA.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Hurd', 'Affiliation': 'Wake Forest Baptist Medical Center, Winston-Salem, NC, USA.'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Hassoun', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Giralt', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Stadtmauer', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Weisdorf', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Vij', 'Affiliation': 'Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Jan S', 'Initials': 'JS', 'LastName': 'Moreb', 'Affiliation': 'University of Florida Health, Gainesville, FL, USA.'}, {'ForeName': 'Natalie S', 'Initials': 'NS', 'LastName': 'Callander', 'Affiliation': 'University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'van Besien', 'Affiliation': 'Weill Medical College of Cornell University, New York, NY, USA.'}, {'ForeName': 'Teresa G', 'Initials': 'TG', 'LastName': 'Gentile', 'Affiliation': 'State University of New York Upstate Medical University, Syracuse, NY, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Isola', 'Affiliation': 'Mount Sinai School of Medicine, New York, NY, USA.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Maziarz', 'Affiliation': 'Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Asad', 'Initials': 'A', 'LastName': 'Bashey', 'Affiliation': 'Blood and Marrow Transplant Program at Northside Hospital, Atlanta, GA, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Landau', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Martin', 'Affiliation': 'University of California at San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Muzaffar H', 'Initials': 'MH', 'LastName': 'Qazilbash', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Rodriguez', 'Affiliation': 'Wake Forest Baptist Medical Center, Winston-Salem, NC, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'McClune', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Schlossman', 'Affiliation': 'Dana-Farber/Partners CancerCare, Boston, MA, USA.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Smith', 'Affiliation': 'Alliance for Clinical Trials in Oncology, Chicago, IL, USA; Loyola University, Chicago, IL, USA.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Hars', 'Affiliation': 'Alliance Statistics and Data Center, Duke University, Durham, NC, USA.'}, {'ForeName': 'Kouros', 'Initials': 'K', 'LastName': 'Owzar', 'Affiliation': 'Alliance Statistics and Data Center, Duke University, Durham, NC, USA.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'Alliance Statistics and Data Center, Duke University, Durham, NC, USA.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Boyd', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Schultz', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Wilson', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Parameswaran', 'Initials': 'P', 'LastName': 'Hari', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Marcelo C', 'Initials': 'MC', 'LastName': 'Pasquini', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'Horowitz', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI, USA; Blood and Marrow Transplant Clinical Trials Network, Rockville, MD, USA.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Shea', 'Affiliation': 'UNC Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Devine', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, OH, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Linker', 'Affiliation': 'University of California at San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Kenneth C', 'Initials': 'KC', 'LastName': 'Anderson', 'Affiliation': 'Dana-Farber/Partners CancerCare, Boston, MA, USA.'}, {'ForeName': 'Philip L', 'Initials': 'PL', 'LastName': 'McCarthy', 'Affiliation': 'Roswell Park Cancer Institute, Buffalo, NY, USA. Electronic address: philip.mccarthy@roswellpark.org.'}]",The Lancet. Haematology,['10.1016/S2352-3026(17)30140-0'] 421,29389694,Acute Effects of Ballistic vs. Passive Static Stretching Involved in a Prematch Warm-up on Vertical Jump and Linear Sprint Performance in Soccer Players.,"ABSTRACT López Mariscal, S, Sánchez Garcia, V, Fernández-García, JC, and Sáez de Villarreal, E. Acute effects of ballistic vs. passive static stretching involved in a prematch warm-up on vertical jump and linear sprint performance in soccer players. J Strength Cond Res 35(1): 147-153, 2021-The purpose of this study was to compare the effects of introducing passive static and ballistic stretching in a standard soccer match warm-up. The variables addressed were the counter movement jump (CMJ), Abalakov jump, and the 40-m linear sprint. The sample was composed of 33 male subjects, divided into 2 age groups. U16 and adult players formed the groups, to cross check whether there were differences between them. Each group was further subdivided into 2 groups regarding the type of stretching carried out during the stretching phase. Before the warm-up, the tests previously described were assessed. In the experimental phase, standard stretching was carried out, consisting of an initial phase in which players had to execute continuous running; a general phase in which players had to make articulate moves; a technical phase in which players had to execute exercises with the ball; a 5 vs. 5 small-sided game was carried out during the tactical phase; and in the final phase, activation exercises and sprints were carried out by the players. Eventually, the same variables were assessed again once the warm-up was finished. There were no statistically significant differences between the 2 types of stretching included in the prematch warm-up. It can be concluded that ballistic and passive static stretching (<10 seconds) did not cause, under these circumstances, any effect in the assessed variables related to soccer performance (linear sprint, CMJ, and Abalakov). This has to be considered by coaches when devising soccer-related warm-ups.",2021,There were no statistically significant differences between the two types of stretching included in the pre-match warm-up.,"['Soccer Players', '33 male subjects, divided in two age groups']","['Ballistic vs Passive Static Stretching', 'execute exercises with the ball; a 5 vs. 5 small sided game', 'passive static and ballistic stretching']","['soccer performance (linear sprint, CMJ and Abalakov', 'Counter Movement Jump (CMJ), Abalakov jump and the 40 m linear sprint']","[{'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}]","[{'cui': 'C1257942', 'cui_str': 'Ballistics'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C1720872', 'cui_str': 'Ballistic Stretching'}]","[{'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0677601', 'cui_str': 'Counter (physical object)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}]",33.0,0.0139685,There were no statistically significant differences between the two types of stretching included in the pre-match warm-up.,"[{'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'López Mariscal', 'Affiliation': 'Section of Physical Education and Sport, Department of Sport and Informatics, Pablo de Olavide University, Sevilla, Spain.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Sánchez Garcia', 'Affiliation': 'Section of Physical Education and Sport, Department of Sport and Informatics, Pablo de Olavide University, Sevilla, Spain.'}, {'ForeName': 'José C', 'Initials': 'JC', 'LastName': 'Fernández-García', 'Affiliation': 'Department of Sport Science, University of Malaga, Malaga, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Sáez de Villarreal', 'Affiliation': 'Section of Physical Education and Sport, Department of Sport and Informatics, Pablo de Olavide University, Sevilla, Spain.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002477'] 422,29297147,"One-Year Cardiovascular Prognosis of the Randomized, Controlled, Short-Term Heart Rate Variability Biofeedback Among Patients with Coronary Artery Disease.","PURPOSE Heart rate variability biofeedback (HRV-BF) is an effective psychophysiological intervention, with short-term effects of increased autonomic nervous system homeostasis, strengthened baroreflex sensitivity, and decreased hostility in patients with coronary artery disease (CAD). The study examined the 1-year HRV-BF effect on cardiovascular prognosis of these patients. METHODS Of 222 patients with CAD referred by cardiologists, 210 were screened and randomly assigned to the HRV-BF and control groups. All patients received psychophysiological assessment and completed psychological questionnaires at pre- and post-interventions and 1-year follow-up. The cardiovascular prognosis primary endpoints included hospital readmission, emergency revisits, and mortality. RESULTS The HRV-BF group had fewer all-cause readmissions (12.00 vs. 25.42%) and all-cause emergency visits (13.33 vs. 35.59%) than the control group. The low-frequency HRV in the HRV-BF group increased at post-intervention and 1-year follow-up compared with that at pre-intervention. Although no significant interaction effect was found in the standard deviation of the normal-to-normal intervals (F = 2.96, p = 0.055), it increased by 26.68% from pre- to post-intervention and 15.77% from pre-intervention to follow-up in the HRV-BF group. However, it decreased by 3.60% from pre- to post-intervention and increased by 1.99% from pre-intervention to follow-up in the control group. Depression and hostility scores decreased significantly at post-intervention and 1-year follow-up only in the HRV-BF group. CONCLUSIONS The long-term HRV-BF effect was confirmed by improved cardiovascular prognosis, increased cardiac autonomic homeostasis and baroreflex sensitivity, and decreased depression and hostility. HRV-BF is an effective psychophysiological intervention with short- and long-term effects in cardiac rehabilitation programs.",2018,"Depression and hostility scores decreased significantly at post-intervention and 1-year follow-up only in the HRV-BF group. ","['222 patients with CAD referred by cardiologists, 210 were screened and randomly assigned to the HRV-BF and control groups', 'Patients with Coronary Artery Disease', 'patients with coronary artery disease (CAD']","['Heart rate variability biofeedback (HRV-BF', 'psychophysiological assessment and completed psychological questionnaires at pre- and post-interventions and 1-year follow-up']","['cause readmissions', 'cause emergency visits', 'standard deviation of the normal-to-normal intervals', 'low-frequency HRV', 'cardiovascular prognosis, increased cardiac autonomic homeostasis and baroreflex sensitivity, and decreased depression and hostility', 'Depression and hostility scores', 'hospital readmission, emergency revisits, and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0175906', 'cui_str': 'Cardiologists'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0033325', 'cui_str': 'Prognosis'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0206162', 'cui_str': 'Reflex, Baroreceptor'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0020039', 'cui_str': 'Hostility'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",222.0,0.0277309,"Depression and hostility scores decreased significantly at post-intervention and 1-year follow-up only in the HRV-BF group. ","[{'ForeName': 'Li-Ching', 'Initials': 'LC', 'LastName': 'Yu', 'Affiliation': 'Department of Psychology, College of Humanities and Social Sciences, Kaohsiung Medical University, 100, Shih-Chuan 1st Road, Kaohsiung, 80708, Taiwan.'}, {'ForeName': 'I-Mei', 'Initials': 'IM', 'LastName': 'Lin', 'Affiliation': 'Department of Psychology, College of Humanities and Social Sciences, Kaohsiung Medical University, 100, Shih-Chuan 1st Road, Kaohsiung, 80708, Taiwan. psyiml@kmu.edu.tw.'}, {'ForeName': 'Sheng-Yu', 'Initials': 'SY', 'LastName': 'Fan', 'Affiliation': 'Institute of Gerontology, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Chin-Lung', 'Initials': 'CL', 'LastName': 'Chien', 'Affiliation': 'Department of Psychology, College of Humanities and Social Sciences, Kaohsiung Medical University, 100, Shih-Chuan 1st Road, Kaohsiung, 80708, Taiwan.'}, {'ForeName': 'Tsung-Hsien', 'Initials': 'TH', 'LastName': 'Lin', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.'}]",International journal of behavioral medicine,['10.1007/s12529-017-9707-7'] 423,31628248,"The MOSEXY trial: mobile phone intervention for sexual health in youth-a pragmatic randomised controlled trial to evaluate the effect of a smartphone application on sexual health in youth in Stockholm, Sweden.","An estimated 350 million cases of STIs occur globally each year. In Sweden, Chlamydia is the most common STI with approximately 30 000 cases annually, disproportionally affecting youth. National surveys report low condom use among youth. Smartphone coverage is high among this tech-savvy group. In collaboration with youth, we developed an interactive smartphone application comprising games, peer experiences and information snippets to promote condom use. OBJECTIVES To evaluate in a randomised controlled trial, the effectiveness of this smartphone application to improve condom use among youth in Stockholm, Sweden. METHODS This two-arm, individually randomised controlled trial was implemented through the Youth Health Clinics (YHC) in Stockholm, Sweden. Youth aged 18-23 years, who owned a smartphone and had ≥2 sexual partners during the past 6 months were eligible. The intervention delivered the interactive elements described above over 180 days. The control group received a 'dummy' application. Both groups received standard of care at the YHC. The primary outcome was proportion of consistent (100%) self-reported condom use at 6 months. Secondary outcomes included self-reported number of partners, occurrence of STIs/pregnancy and STI tests during the study period. An intention-to-treat approach was used. RESULTS 214 and 219 youth were randomised to the intervention and control groups, respectively. Consistent condom use was reported for 32/214 (15.0%) in the intervention group and for 35/219 (16.0%) in the control group (OR 0.9, 95% CI 0.5 to 1.6). No significant differences in secondary outcomes were seen. CONCLUSION We were unable to detect an effect of the intervention. Future research should focus on targeting different subgroups within the overall risk group, with tailored mHealth interventions. The potential for such interventions in settings where sexual health services are unavailable should be evaluated. TRIAL REGISTRATION NUMBER ISRCTN13212899.",2021,"Consistent condom use was reported for 32/214 (15.0%) in the intervention group and for 35/219 (16.0%) in the control group (OR 0.9, 95% CI 0.5 to 1.6).","['Youth aged 18-23 years, who owned a smartphone and had ≥2 sexual partners during the past 6 months were eligible', 'youth in Stockholm, Sweden', 'Youth Health Clinics (YHC) in Stockholm, Sweden', 'National surveys report low condom use among youth', 'sexual health in youth in Stockholm, Sweden', '214 and 219 youth']","[""dummy' application"", 'smartphone application', 'standard of care at the YHC']","['self-reported number of partners, occurrence of STIs/pregnancy and STI tests', 'proportion of consistent (100%) self-reported condom use']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0036911', 'cui_str': 'Sexual Partners'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C4517648', 'cui_str': '219 (qualifier value)'}]","[{'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",219.0,0.171375,"Consistent condom use was reported for 32/214 (15.0%) in the intervention group and for 35/219 (16.0%) in the control group (OR 0.9, 95% CI 0.5 to 1.6).","[{'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Nielsen', 'Affiliation': 'Womens and Childrens Health, Karolinska Institutet, Stockholm, Sweden anna.nielsen.1@ki.se.'}, {'ForeName': 'Ayesha', 'Initials': 'A', 'LastName': 'De Costa', 'Affiliation': 'Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Gemzell-Danielsson', 'Affiliation': 'Womens and Childrens Health, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Marrone', 'Affiliation': 'Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Boman', 'Affiliation': 'Department of Clinical Microbiology, Umea Universitet Medicinska fakulteten, Umea, Sweden.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Salazar', 'Affiliation': 'Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Vinod', 'Initials': 'V', 'LastName': 'Diwan', 'Affiliation': 'Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.'}]",Sexually transmitted infections,['10.1136/sextrans-2019-054027'] 424,32412388,The factor structure of the Working Alliance Inventory short-form in youth psychotherapy: an empirical investigation.,"Objective: The Working Alliance Inventory short form (WAI-S) is one of the most commonly used alliance measures with adolescents. Yet, its factor structure has received minimal attention in the youth alliance literature. This study investigated the factor structure of the WAI-S in psychotherapy for adolescent depression and explored its measurement invariance across time, therapeutic approaches and patients' and therapists' perspectives. The existence of method effects associated with the negatively worded items of the scale was also assessed. Method: The setting of this study is the IMPACT trial, a randomized controlled trial assessing the effects of three therapeutic interventions in the treatment of adolescent depression. The WAI-S was completed at 6, 12 and 36 weeks after randomization by 338 adolescents and 159 therapists. Data were analysed using confirmatory factor analysis. Results: The hypothesized Bond-Task-Goal alliance structure was not supported and a general, one-factor model was found to be more psychometrically valid. The existence of a method effect and measurement invariance across time and treatment arms were also found. Conclusions: While the distinction between the specific alliance dimensions is conceptually and clinically interesting, at an empirical level the alliance features of the WAI-S in youth psychotherapy remain strongly intercorrelated.",2021,"The hypothesized Bond-Task-Goal alliance structure was not supported and a general, one-factor model was found to be more psychometrically valid.","['338 adolescents and 159 therapists', 'adolescent depression', 'youth psychotherapy']",['Working Alliance Inventory short form (WAI-S'],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]",[],338.0,0.071215,"The hypothesized Bond-Task-Goal alliance structure was not supported and a general, one-factor model was found to be more psychometrically valid.","[{'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Cirasola', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Midgley', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fonagy', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Martin', 'Affiliation': 'Child Attachment and Psychological Therapies Research Unit (ChAPTRe), Anna Freud National Centre for Children and Families, London, UK.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2020.1765041'] 425,31886591,Effect of a pharmacist-led intervention on adherence among patients with a first-time prescription for a cardiovascular medicine: a randomized controlled trial in Norwegian pharmacies.,"OBJECTIVE To examine whether a pharmacist-led intervention improves medication adherence among patients who have filled a first-time prescription for a cardiovascular medicine. METHODS Design: Unblinded randomized controlled trial. SETTING 67 Norwegian pharmacies, October 2014-June 2015. PARTICIPANTS 1480 adults with a first-time prescription for a cardiovascular medicine. INTERVENTION Participants in the intervention group received two consultations with a pharmacist 1-2 and 3-5 weeks after filling the prescription. Participants in the control group received care according to usual practice. MAIN OUTCOME MEASURE The primary outcome was self-reported adherence as measured by the 8-item Morisky Medication Adherence Scale (MMAS-8), at 7 and 18 weeks after filling the prescription. Adherence from baseline to week 52 was estimated using data from the Norwegian Prescription Database (NPD). KEY FINDINGS Data from MMAS-8 showed that 91.3% of the patients in the intervention group were adherent after 7 weeks versus 86.8% in the control group (4.5% difference, 95% CI 0.8-8.2, P = 0.017). The corresponding proportions were 88.7% versus 83.7% after 18 weeks (5.0% difference, 95% CI 0.8-9.2, P = 0.021). NPD data (n = 1294) showed no significant difference in adherence after 52 weeks (95% CI -2.0 to 7.8, P = 0.24). However, adherence among statin users (n = 182) was 66.5% in the intervention group versus 57.4% among new statin users in the general population (n = 1500) (difference 9.1%, 95% CI 1.5-16.0, P = 0.019). CONCLUSION The main outcome measure indicates that a short, structured pharmacist-led intervention may increase medication adherence for patients starting on chronic cardiovascular medication. However, these findings could not be confirmed by the NPD data analysis.",2020,"(difference 9.1%, 95% CI 1.5-16.0, P = 0.019). ","['Design', '67 Norwegian pharmacies, October 2014-June 2015', 'patients who have filled a first-time prescription for a cardiovascular medicine', 'patients with a first-time prescription for a cardiovascular medicine', '1480 adults with a first-time prescription for a cardiovascular medicine']","['pharmacist-led intervention', 'care according to usual practice']","['adherence', 'medication adherence', 'self-reported adherence as measured by the 8-item Morisky Medication Adherence Scale (MMAS-8']","[{'cui': 'C0337812', 'cui_str': 'Norwegians (ethnic group)'}, {'cui': 'C0031322', 'cui_str': 'Pharmacies'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0222045'}]",1480.0,0.216021,"(difference 9.1%, 95% CI 1.5-16.0, P = 0.019). ","[{'ForeName': 'Ragnar', 'Initials': 'R', 'LastName': 'Hovland', 'Affiliation': 'Apokus, National Centre for Development of Pharmacy Practice, Oslo, Norway.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Bremer', 'Affiliation': 'Apokus, National Centre for Development of Pharmacy Practice, Oslo, Norway.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Frigaard', 'Affiliation': 'Apokus, National Centre for Development of Pharmacy Practice, Oslo, Norway.'}, {'ForeName': 'Solveig', 'Initials': 'S', 'LastName': 'Henjum', 'Affiliation': 'Norwegian Pharmacy Association, Oslo, Norway.'}, {'ForeName': 'Per Kristian', 'Initials': 'PK', 'LastName': 'Faksvåg', 'Affiliation': 'Norwegian Pharmacy Association, Oslo, Norway.'}, {'ForeName': 'Erik Magnus', 'Initials': 'EM', 'LastName': 'Saether', 'Affiliation': 'Oslo Economics, Oslo, Norway.'}, {'ForeName': 'Ivar Sønbø', 'Initials': 'IS', 'LastName': 'Kristiansen', 'Affiliation': 'Oslo Economics, Oslo, Norway.'}]",The International journal of pharmacy practice,['10.1111/ijpp.12598'] 426,28623849,"Population Pharmacokinetics/Pharmacodynamics of 3,4-Diaminopyridine Free Base in Patients With Lambert-Eaton Myasthenia.","Lambert-Eaton myasthenia (LEM) is a rare autoimmune disorder associated with debilitating muscle weakness. There are limited treatment options and 3,4-diaminopyridine (3,4-DAP) free base is an investigational orphan drug used to treat LEM-related weakness. We performed a population pharmacokinetic/pharmacodynamic (PK/PD) analysis using 3,4-DAP and metabolite concentrations collected from a phase II study in patients with LEM. The Triple Timed Up & Go (3TUG) assessment, which measures lower extremity weakness, was the primary outcome measure. A total of 1,270 PK samples (49 patients) and 1,091 3TUG data points (32 randomized patients) were included in the PK/PD analysis. A two-compartment and one-compartment model for parent and metabolite, respectively, described the PK data well. Body weight and serum creatinine partially explained the variability in clearance for the final PK model. A fractional inhibitory maximum effect (E max ) model characterized the exposure-response relationship well. The PK/PD model was applied to identify a suggested dosing approach for 3,4-DAP free base.",2017,"The Triple Timed Up & Go (3TUG) assessment, which measures lower extremity weakness, was the primary outcome measure.","['Patients With Lambert-Eaton Myasthenia', 'patients with LEM', 'A total of 1,270 PK samples (49 patients) and 1,091 3TUG data points (32 randomized patients) were included in the PK/PD analysis']","['Lambert-Eaton myasthenia (LEM', '3,4-Diaminopyridine', '3,4-diaminopyridine']",['Body weight and serum creatinine'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0947912'}, {'cui': 'C0115922', 'cui_str': 'leukocyte pyrogen'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0947912'}, {'cui': 'C0115922', 'cui_str': 'leukocyte pyrogen'}, {'cui': 'C0046948', 'cui_str': '3,4-Pyridinediamine'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}]",32.0,0.049487,"The Triple Timed Up & Go (3TUG) assessment, which measures lower extremity weakness, was the primary outcome measure.","[{'ForeName': 'Nilay', 'Initials': 'N', 'LastName': 'Thakkar', 'Affiliation': 'Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Guptill', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Aleš', 'Affiliation': 'Jacobus Pharmaceutical Company, Inc., Plainsboro, New Jersey, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jacobus', 'Affiliation': 'Jacobus Pharmaceutical Company, Inc., Plainsboro, New Jersey, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Jacobus', 'Affiliation': 'Jacobus Pharmaceutical Company, Inc., Plainsboro, New Jersey, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Peloquin', 'Affiliation': 'College of Pharmacy and Emerging Pathogens Institute, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cohen-Wolkowiez', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gonzalez', 'Affiliation': 'Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",CPT: pharmacometrics & systems pharmacology,['10.1002/psp4.12218'] 427,29309387,Positive Pressure Ventilation Improves Exercise Performance and Attenuates the Fall of Postexercise Inspiratory Muscular Strength in Rower Athletes.,"ABSTRACT Gonçalves, TR and Soares, PP. Positive pressure ventilation improves exercise performance and attenuates the fall of postexercise inspiratory muscular strength in rower athletes. J Strength Cond Res 35(1): 253-259, 2021-Positive pressure ventilation (PPV) can increase exercise performance in cyclists, but its effects are unclear in other exercise modes, especially those using large muscle mass. The aim of this study was to compare the exercise performance and postexercise inspiratory muscles' strength with and without PPV (NO-PPV) during rowing. Nine male rowers (19 ± 1 year) participated in 3 experimental days (M1, M2, and M3) separated by 1 week. In M1, rowers performed a 2,000-m test (2k) on a rowing ergometer to obtain average power (W2k). In M2 and M3, the rowers performed 4 minutes' workouts at 55, 65, 75, and 85% W2k, respectively, separated by 1 minute of recovery, with PPV and NO-PPV application in randomized order. Blood lactate (La) was measured during intervals. After submaximal exercises, with 10 minutes of ""cool down,"" the rowers performed a maximal performance test of 4 minutes (4-minute all-out rowing). Traveled distance was computed and correlated with maximal inspiratory pressure (MIP) changes from pretest to posttest (∆). Positive pressure ventilation application increased the traveled distance in relation to NO-PPV exercise (1,210.7 ± 45.5 vs. 1,199.8 ± 43.4 m, p ≤ 0.05). The ∆MIP (cmH2O) was lower in PPV as compared to NO-PPV exercise (-19.1 ± 10.2 vs. -26.3 ± 7.9 cmH2O, p ≤ 0.05). The [La] showed no significant difference between PPV and NO-PPV exercises (p > 0.05). Therefore, the PPV during whole-body rowing exercise improved the exercise performance and attenuated the inspiratory postexercise fatigue. These findings suggest that inspiratory muscles' strength plays a role during high-intensity exercise with large muscle mass.",2021,"PPV application increased the traveled distance in relation to NO-PPV exercise (1210.7 ± 45.5 vs. 1199.8 ± 43.4 m, p < 0.05).","[""rower's athletes"", 'Nine male rowers (19 ± 1 years) participated in three experimental days (M1, M2, and M3) separated by one week']","[""post-exercise inspiratory muscles' strength with and without PPV (NO-PPV"", 'Positive pressure ventilation', 'Positive pressure ventilation (PPV', 'rowing ergometer to obtain average power (W2k']","['maximal inspiratory pressure (MIP) changes', 'PPV and NO-PPV exercises', 'exercise performance', 'Blood lactate (Lac', 'ΔMIP (cmH2O']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C1442452', 'cui_str': 'One week'}]","[{'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C3266857', 'cui_str': 'Positive-Pressure Ventilation'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}]","[{'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0439476', 'cui_str': 'cmH2O'}]",9.0,0.0376611,"PPV application increased the traveled distance in relation to NO-PPV exercise (1210.7 ± 45.5 vs. 1199.8 ± 43.4 m, p < 0.05).","[{'ForeName': 'Thiago R', 'Initials': 'TR', 'LastName': 'Gonçalves', 'Affiliation': 'Department of Physiology and Pharmacology, Laboratory of Experimental and Applied Exercise Physiology, Fluminense Federal University, Niterói, Brazil.'}, {'ForeName': 'Pedro Paulo da S', 'Initials': 'PPDS', 'LastName': 'Soares', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002420'] 428,29065052,Energy Drink Doses of Caffeine and Taurine Have a Null or Negative Effect on Sprint Performance.,"Jeffries, O, Hill, J, Patterson, SD, and Waldron, M. Energy drink doses of caffeine and taurine have a null or negative effect on sprint performance. J Strength Cond Res 34(12): 3475-3481, 2020-This study investigated the effects of caffeine and taurine coingestion on repeat-sprint cycling performance and associated physiological and perceptual responses. In a double-blind, cross-over, repeated measures study, 11 male subjects (age 21 ± 2 years; stature 178 ± 7 cm; body mass 80 ± 13 kg) completed 10 × 6-second sprints on a cycle ergometer, each separated by 24 seconds, one hour after ingesting: caffeine (80 mg) and taurine (1 g), equivalent to the amount observed in popular commercial energy drinks, or placebo (maltodextrin ∼1 g) in a gelatine capsule. Performance was measured on a cycle ergometer, whereas blood lactate concentration (B[la]), rating of perceived exertion (RPE), and heart rate (HR) were measured at baseline (pre-exercise) and after sprints 5 and 10. Magnitude-based inferences revealed likely, trivial differences in peak power and unclear, trivial intersprint fatigue index after ingestion of the caffeine and taurine supplement. Intrasprint fatigue was greater in the caffeine and taurine condition at sprint 10 (likely, small) and possibly smaller in sprints 6-9. The caffeine and taurine supplement had a likely large effect on HR at baseline (effect size = 0.94) and increases in B[la] after sprints 5 (likely small) and 10 (possibly small). There was no effect of the supplement on RPE (unclear, trivial). Administration of caffeine and taurine at doses equivalent to commercial energy drinks did not improve repeat-sprint cycling performance and seemed to induce greater fatigue within selected sprints, particularly at the end of the trial. This undesirable performance effect occurs in parallel with increased HR and glycolytic metabolic bi-products.",2020,"Administration of caffeine and taurine at doses equivalent to commercial energy drinks did not improve repeat-sprint cycling performance and appeared to induce greater fatigue within selected sprints, particularly at the end of the trial.",['11 male participants (age 21 ± 2 years; stature 178 ± 7 cm; body mass 80 ± 13 kg'],"['caffeine and taurine co-ingestion', 'Caffeine', 'caffeine and taurine', 'caffeine and taurine supplement', 'caffeine (80 mg) and taurine (1 g), equivalent to the amount observed in popular commercial energy drinks, or placebo (maltodextrin ∼1 g) in a gelatine capsule']","['repeat-sprint cycling performance', 'cycle ergometer, whilst blood lactate concentration (B[la]), rating of perceived exertion (RPE) and heart rate (HR', 'peak power and unclear, trivial inter-sprint fatigue index', 'repeat-sprint cycling performance and associated physiological and perceptual responses', 'Intra-sprint fatigue', 'B[la']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0039350', 'cui_str': 'Taurine'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C3179078', 'cui_str': 'Energy Drinks'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}]",11.0,0.218222,"Administration of caffeine and taurine at doses equivalent to commercial energy drinks did not improve repeat-sprint cycling performance and appeared to induce greater fatigue within selected sprints, particularly at the end of the trial.","[{'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Jeffries', 'Affiliation': ""School of Sport, Health and Applied Science, St Mary's University, Twickenham, United Kingdom; and.""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Hill', 'Affiliation': ""School of Sport, Health and Applied Science, St Mary's University, Twickenham, United Kingdom; and.""}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Patterson', 'Affiliation': ""School of Sport, Health and Applied Science, St Mary's University, Twickenham, United Kingdom; and.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Waldron', 'Affiliation': ""School of Sport, Health and Applied Science, St Mary's University, Twickenham, United Kingdom; and.""}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002299'] 429,29016474,Cardiac Autonomic and Blood Pressure Responses to an Acute Bout of Kettlebell Exercise.,"ABSTRACT Wong, A, Nordvall, M, Walters-Edwards, M, Lastova, K, Francavillo, G, Tripken, J, Summerfield, L, and Sanchez-Gonzalez, M. Cardiac autonomic and blood pressure responses to an acute bout of kettlebell exercise. J Strength Cond Res 35(2S): S173-S179, 2021-Kettlebell (KB) training has become an extremely popular exercise program for improving both muscle strength and aerobic fitness. However, the cardiac autonomic modulation and blood pressure (BP) responses induced by an acute KB exercise session are currently unknown. Understanding the impact of this exercise modality on the postexercise autonomic modulation and BP would facilitate appropriate exercise prescription in susceptible populations. This study evaluated the effects of an acute session of KB exercise on heart rate variability and BP responses in healthy individuals. Seventeen (male = 10 and female = 7) healthy subjects completed either a KB or nonexercise control trial in randomized order. Heart rate variability and BP measurements were collected at baseline, 3, 10, and 30 minutes after each trial. There were significant increases (p < 0.01) in heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (nLF/nHF) for 30 minutes after the KB trial, whereas no changes from baseline were observed after the control trial. There were also significant decreases (p < 0.01) in markers of vagal tone (RMMSD and nHF) for 30 minutes as well as (p < 0.01) systolic BP and diastolic BP at 10 and 30 minutes after the KB trial, whereas no changes from baseline were observed after the control trial. Our findings indicate that KB exercise increases sympathovagal balance for 30 minutes postintervention, which is concurrent with an important hypotensive effect. Further research is warranted to evaluate the potential clinical application of KB training in populations that might benefit from postexercise hypotension, such as hypertensives.",2021,"There were significant increases (P < 0.01) in heart rate, markers of sympathetic activity (nLF) and sympathovagal balance (nLF/nHF) for 30 min after the trial KB trial, while no changes from baseline were observed after the control trial.","['healthy individuals', 'Seventeen (M=10, F=7) healthy subjects completed either a', 'Acute Bout of Kettlebell Exercise']","['KB exercise', 'KB training', 'KB or non-exercise control', 'Kettlebell (KB) training']","['heart rate variability (HRV) and BP responses', 'markers of vagal tone (RMMSD, nHF', 'systolic BP and diastolic BP', 'heart rate, markers of sympathetic activity (nLF) and sympathovagal balance (nLF/nHF', 'cardiac autonomic modulation and blood pressure (BP) responses', 'HRV and BP measurements', 'Cardiac Autonomic and Blood Pressure Responses', 'sympathovagal balance']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response (observable entity)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",,0.131644,"There were significant increases (P < 0.01) in heart rate, markers of sympathetic activity (nLF) and sympathovagal balance (nLF/nHF) for 30 min after the trial KB trial, while no changes from baseline were observed after the control trial.","[{'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Health and Human Performance, Marymount University, Arlington, Virginia; and.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nordvall', 'Affiliation': 'Department of Health and Human Performance, Marymount University, Arlington, Virginia; and.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Walters-Edwards', 'Affiliation': 'Department of Health and Human Performance, Marymount University, Arlington, Virginia; and.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Lastova', 'Affiliation': 'Department of Health and Human Performance, Marymount University, Arlington, Virginia; and.'}, {'ForeName': 'Gwendolyn', 'Initials': 'G', 'LastName': 'Francavillo', 'Affiliation': 'Department of Health and Human Performance, Marymount University, Arlington, Virginia; and.'}, {'ForeName': 'Liane', 'Initials': 'L', 'LastName': 'Summerfield', 'Affiliation': 'Department of Health and Human Performance, Marymount University, Arlington, Virginia; and.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Sanchez-Gonzalez', 'Affiliation': 'Division of Clinical and Translational Research, Larkin Community Hospital, South Miami, Florida.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002279'] 430,31584721,Randomized Controlled Trial of the Marriage Checkup: Depression Outcomes.,"The association between relationship functioning and depressive symptoms is well established. This study examined the effects of the Marriage Checkup, a brief two-session Assessment and Feedback relationship intervention, on depressive symptoms. Two hundred and nine married couples participated in the Marriage Checkup and were randomized into Treatment (N = 108) and Waitlist-Control Conditions (N = 101). Compared to the control condition, intervention participants reported significant improvements in depressive symptoms (d = 0.55), with an even greater effect for those who were reporting more severe baseline depression symptoms (d = 0.67). These outcomes are comparable to those within long-term individual psychotherapy, couple therapy, and pharmacology trials, making this the briefest intervention to date to demonstrate significant improvements in depressive symptoms. Clinical implications are discussed.",2020,"Compared to the control condition, intervention participants reported significant improvements in depressive symptoms (d = 0.55), with an even greater effect for those who were reporting more severe baseline depression symptoms (d = 0.67).",['Two hundred and nine married couples participated in the Marriage Checkup'],"['Marriage Checkup, a brief two-session Assessment and Feedback relationship intervention']","['depressive symptoms', 'severe baseline depression symptoms']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}]","[{'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0402276,"Compared to the control condition, intervention participants reported significant improvements in depressive symptoms (d = 0.55), with an even greater effect for those who were reporting more severe baseline depression symptoms (d = 0.67).","[{'ForeName': 'Tatiana D', 'Initials': 'TD', 'LastName': 'Gray', 'Affiliation': 'Clark University.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Hawrilenko', 'Affiliation': 'VA Puget Sound Healthcare System.'}, {'ForeName': 'James V', 'Initials': 'JV', 'LastName': 'Cordova', 'Affiliation': 'Clark University.'}]",Journal of marital and family therapy,['10.1111/jmft.12411'] 431,27401564,Population Pharmacokinetics of Fluconazole in Premature Infants with Birth Weights Less than 750 Grams.,"Fluconazole is an effective agent for prophylaxis of invasive candidiasis in premature infants. The objective of this study was to characterize the population pharmacokinetics (PK) and dosing requirements of fluconazole in infants with birth weights of <750 g. As part of a randomized clinical trial, infants born at <750 g birth weight received intravenous (i.v.) or oral fluconazole at 6 mg/kg of body weight twice weekly. Fluconazole plasma concentrations from samples obtained by either scheduled or scavenged sampling were measured using a liquid chromatography-tandem mass spectrometry assay. Population PK analysis was conducted using NONMEM 7.2. Population PK parameters were allometrically scaled by body weight. Covariates were evaluated by univariable screening followed by multivariable assessment. Fluconazole exposures were simulated in premature infants using the final PK model. A population PK model was developed from 141 infants using 604 plasma samples. Plasma fluconazole PK were best described by a one-compartment model with first-order elimination. Only serum creatinine was an independent predictor for clearance in the final model. The typical population parameter estimate for oral bioavailability in the final model was 99.5%. Scavenged samples did not bias the parameter estimates and were as informative as scheduled samples. Simulations indicated that the study dose maintained fluconazole troughs of >2,000 ng/ml in 80% of simulated infants at week 1 and 59% at week 4 of treatment. Developmental changes in fluconazole clearance are best predicted by serum creatinine in this population. A twice-weekly dose of 6 mg/kg achieves appropriate levels for prevention of invasive candidiasis in extremely premature infants.",2016,Scavenged samples did not bias the parameter estimates and were as informative as scheduled samples.,"['premature infants using the final PK model', 'extremely premature infants', '141 infants using 604 plasma samples', 'infants with birth weights of <750 g', 'premature infants', 'Premature Infants with Birth Weights Less than 750 Grams', 'infants born at <750 g birth weight received']","['fluconazole', 'intravenous (i.v.) or oral fluconazole', 'Fluconazole']","['oral bioavailability', 'Fluconazole plasma concentrations']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C3494262', 'cui_str': 'Extremely Preterm Infants'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}]","[{'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0306005,Scavenged samples did not bias the parameter estimates and were as informative as scheduled samples.,"[{'ForeName': 'Jeremiah D', 'Initials': 'JD', 'LastName': 'Momper', 'Affiliation': 'University of California, San Diego, La Jolla, California, USA.'}, {'ForeName': 'Edmund V', 'Initials': 'EV', 'LastName': 'Capparelli', 'Affiliation': 'University of California, San Diego, La Jolla, California, USA.'}, {'ForeName': 'Kelly C', 'Initials': 'KC', 'LastName': 'Wade', 'Affiliation': ""Children's Hospital of Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Kantak', 'Affiliation': ""Children's Hospital Medical Center of Akron, Akron, Ohio, USA.""}, {'ForeName': 'Ramasubbareddy', 'Initials': 'R', 'LastName': 'Dhanireddy', 'Affiliation': 'University of Tennessee Health System, Memphis, Tennessee, USA.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Cummings', 'Affiliation': 'East Carolina University, Brody School of Medicine, Greenville, North Carolina, USA.'}, {'ForeName': 'Jonathan H', 'Initials': 'JH', 'LastName': 'Nedrelow', 'Affiliation': ""Cook Children's Medical Center, Fort Worth, Texas, USA.""}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Hudak', 'Affiliation': 'University of Florida College of Medicine, Jacksonville, Florida, USA.'}, {'ForeName': 'Gratias T', 'Initials': 'GT', 'LastName': 'Mundakel', 'Affiliation': 'Kings County Hospital, Brooklyn, New York, USA.'}, {'ForeName': 'Girija', 'Initials': 'G', 'LastName': 'Natarajan', 'Affiliation': 'Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Laughon', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'P Brian', 'Initials': 'PB', 'LastName': 'Smith', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA Duke Clinical Research Institute, Durham, North Carolina, USA brian.smith@duke.edu.'}, {'ForeName': 'Daniel K', 'Initials': 'DK', 'LastName': 'Benjamin', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA Duke Clinical Research Institute, Durham, North Carolina, USA.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.00963-16'] 432,28334684,Biochemical signaling by remote ischemic conditioning of the arm versus thigh: Is one raise of the cuff enough?,"Remote Ischemic Conditioning (RIC), induced by brief cycles of ischemia and reperfusion, protects vital organs from a prolonged ischemic insult. While several biochemical mediators have been implicated in RIC's mechanism of action, it remains unclear whether the localization or ""dose"" of RIC affects the extent of protective signaling. In this randomized crossover study of healthy individuals, we tested whether the number of cycles of RIC and its localization (arm versus thigh) determines biochemical signaling and cytoprotection. Subjects received either arm or thigh RIC and then were crossed over to receive RIC in the other extremity. Blood flow, tissue perfusion, concentrations of the circulating protective mediator nitrite, and platelet mitochondrial function were measured after each RIC cycle. We found that plasma nitrite concentration peaked after the first RIC cycle and remained elevated throughout RIC. This plasma nitrite conferred cytoprotection in an in vitro myocyte model of hypoxia/reoxygenation. Notably, though plasma nitrite returned to baseline at 24h, RIC conditioned plasma still mediated protection. Additionally, no difference in endpoints between RIC in thigh versus arm was found. These data demonstrate that localization and ""dose"" of RIC does not affect cytoprotection and further elucidate the mechanisms by which nitrite contributes to RIC-dependent protection.",2017,"Additionally, no difference in endpoints between RIC in thigh versus arm was found.",['healthy individuals'],"['thigh', 'Remote Ischemic Conditioning (RIC']","['plasma nitrite concentration', 'plasma nitrite', 'Blood flow, tissue perfusion, concentrations of the circulating protective mediator nitrite, and platelet mitochondrial function']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0039866', 'cui_str': 'Thigh'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0427757', 'cui_str': 'Dipstick test of nitrite concentration'}, {'cui': 'C0028137', 'cui_str': 'Nitrites'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0429877', 'cui_str': 'Tissue perfusion measure'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.0652611,"Additionally, no difference in endpoints between RIC in thigh versus arm was found.","[{'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Dezfulian', 'Affiliation': 'Safar Center for Resuscitation, University of Pittsburgh School of Medicine, Pittsburgh, PA 15261, USA; Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA 15261, USA; Vascular Medicine Institute, University of Pittsburgh School of Medicine, Pittsburgh, PA 15261, USA.'}, {'ForeName': 'Maia', 'Initials': 'M', 'LastName': 'Taft', 'Affiliation': 'Safar Center for Resuscitation, University of Pittsburgh School of Medicine, Pittsburgh, PA 15261, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Corey', 'Affiliation': 'Vascular Medicine Institute, University of Pittsburgh School of Medicine, Pittsburgh, PA 15261, USA; Department of Pharmacology & Chemical Biology, University of Pittsburgh School of Medicine, Pittsburgh, PA 15261, USA.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Hill', 'Affiliation': 'Vascular Medicine Institute, University of Pittsburgh School of Medicine, Pittsburgh, PA 15261, USA; Department of Pharmacology & Chemical Biology, University of Pittsburgh School of Medicine, Pittsburgh, PA 15261, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Krehel', 'Affiliation': 'Safar Center for Resuscitation, University of Pittsburgh School of Medicine, Pittsburgh, PA 15261, USA; Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA 15261, USA.'}, {'ForeName': 'Jon C', 'Initials': 'JC', 'LastName': 'Rittenberger', 'Affiliation': 'Applied Physiology Laboratory, Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA 15261, USA.'}, {'ForeName': 'Frank X', 'Initials': 'FX', 'LastName': 'Guyette', 'Affiliation': 'Applied Physiology Laboratory, Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA 15261, USA.'}, {'ForeName': 'Sruti', 'Initials': 'S', 'LastName': 'Shiva', 'Affiliation': 'Vascular Medicine Institute, University of Pittsburgh School of Medicine, Pittsburgh, PA 15261, USA; Applied Physiology Laboratory, Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA 15261, USA; Department of Pharmacology & Chemical Biology, University of Pittsburgh School of Medicine, Pittsburgh, PA 15261, USA. Electronic address: sss43@pitt.edu.'}]",Redox biology,['10.1016/j.redox.2017.03.010'] 433,28323305,Exercise to reduce work-related fatigue among employees: a randomized controlled trial.,"Objectives The present study evaluated the efficacy of an exercise intervention to reduce work-related fatigue (emotional exhaustion, overall fatigue, and need for recovery). The effects of exercise on self-efficacy, sleep, work ability, cognitive functioning and aerobic fitness (secondary outcomes) were also investigated. Methods Employees with high levels of work-related fatigue were randomly assigned to either a 6-week exercise intervention (EI; N=49) or a wait-list control group (WLC; N=47). All participants were measured pre- (T0) and post-intervention (T1). EI participants were also measured 6 (T2) and 12 weeks (T3) after the end of the intervention. Analyses were based on intention-to-treat (ITT) and per-protocol (PP). PP analyses only included EI participants (N=31) who completed the intervention and WLC participants (N= 35) who did not increase their exercise level during the wait period. Results Analyses of covariance (ANCOVA) revealed that, at T1, the EI group reported lower emotional exhaustion and overall fatigue than the WLC group, however, only according to PP analyses. Both according to ITT and PP analyses, EI participants showed higher sleep quality, work ability, and self-reported cognitive functioning at T1 compared to WLC participants. Intervention effects were maintained at T2 and T3. Conclusions The exercise intervention had enduring effects on work-related fatigue and broader indicators of employee well-being. This study demonstrates that, in case of work-related fatigue, exercise does constitute a powerful medicine for those who comply with the treatment.",2017,"Both according to ITT and PP analyses, EI participants showed higher sleep quality, work ability, and self-reported cognitive functioning at T1 compared to WLC participants.","['employees', 'Methods Employees with high levels of work-related fatigue', 'PP analyses only included EI participants (N=31) who completed the intervention and WLC participants (N= 35']","['6-week exercise intervention (EI; N=49) or a wait-list control group (WLC', 'Exercise', 'exercise intervention']","['exercise level', 'self-efficacy, sleep, work ability, cognitive functioning and aerobic fitness (secondary outcomes', 'emotional exhaustion and overall fatigue', 'sleep quality, work ability, and self-reported cognitive functioning', 'work-related fatigue (emotional exhaustion, overall fatigue, and need for recovery']","[{'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}]",,0.0583395,"Both according to ITT and PP analyses, EI participants showed higher sleep quality, work ability, and self-reported cognitive functioning at T1 compared to WLC participants.","[{'ForeName': 'Juriena D', 'Initials': 'JD', 'LastName': 'de Vries', 'Affiliation': 'Behavioural Science Institute, Radboud University, P.O. Box 9104, 6500 HE, Nijmegen, The Netherlands. j.devries@psych.ru.nl.'}, {'ForeName': 'Madelon L M', 'Initials': 'MLM', 'LastName': 'van Hooff', 'Affiliation': ''}, {'ForeName': 'Sabine A E', 'Initials': 'SAE', 'LastName': 'Geurts', 'Affiliation': ''}, {'ForeName': 'Michiel A J', 'Initials': 'MAJ', 'LastName': 'Kompier', 'Affiliation': ''}]","Scandinavian journal of work, environment & health",['10.5271/sjweh.3634'] 434,30035580,"Alternate versions of a fixed-choice, delay-discounting assessment for repeated-measures designs.","Delay discounting, reflected in the tendency to prefer immediate rewards over delayed rewards, is associated with most forms of problematic substance use. When assessed multiple times to examine within-individual changes, for example, following acute drug administration or an intervention, shifts in delay discounting simply because of repeated assessment is a concern, particularly when the assessment task is identical. This may be true for the Monetary Choice Questionnaire (MCQ), a widely used, fixed-item assessment of delay discounting. The present research examined possible within-individual difference/equivalence of MCQ indices at test/retest. This was contrasted with within-individual difference/equivalence when using an alternate version of the MCQ at retest, specifically developed to maintain the assessment structure and scoring of the original MCQ but with different choice items. Eighty-four participants completed delay discounting at test and retest with a 1-week interval; participants were randomized to complete the MCQ at both test and retest (MCQ/MCQ; n = 43) or complete the MCQ at test and an alternate version of the MCQ at retest (MCQ/MCQ-A; n = 41). Conventional hypothesis testing indicated no significant changes in delay discounting in the MCQ/MCQ condition or MCQ/MCQ-A condition. However, equivalence analysis, which is able to established whether scores are statistically equivalent, indicated that test/retest scores were not equivalent in some cases. Specifically, only 1 magnitude in the MCQ/MCQ condition was equivalent at test/retest, whereas 2 magnitudes in the MCQ/MCQ-A condition were equivalent at test/retest. (PsycINFO Database Record (c) 2018 APA, all rights reserved).",2018,Conventional hypothesis testing indicated no significant changes in delay discounting in the MCQ/MCQ condition or MCQ/MCQ-A condition.,[],[],['delay discounting'],[],[],"[{'cui': 'C3850035', 'cui_str': 'Intertemporal Decision Making'}]",84.0,0.030216,Conventional hypothesis testing indicated no significant changes in delay discounting in the MCQ/MCQ condition or MCQ/MCQ-A condition.,"[{'ForeName': 'Jinyi', 'Initials': 'J', 'LastName': 'Kuang', 'Affiliation': 'Social Norms Group.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Milhorn', 'Affiliation': 'Department of Health Education and Behavior.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Stuppy-Sullivan', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Soyeon', 'Initials': 'S', 'LastName': 'Jung', 'Affiliation': 'Department of Health Education and Behavior.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Yi', 'Affiliation': 'Department of Health Education and Behavior.'}]",Experimental and clinical psychopharmacology,['10.1037/pha0000211'] 435,27683185,Association Between Single Gene Polymorphisms and Bone Biomarkers and Response to Calcium and Vitamin D Supplementation in Young Adults Undergoing Military Training.,"Initial military training (IMT) is associated with increased stress fracture risk. In prior studies, supplemental calcium (Ca) and vitamin D provided daily throughout IMT reduced stress fracture incidence, suppressed parathyroid hormone (PTH), and improved measures of bone health compared with placebo. Data were analyzed from a randomized, double-blind, placebo-controlled trial to determine whether single-nucleotide polymorphisms (SNPs) in Ca and vitamin D-related genes were associated with circulating biomarkers of bone metabolism in young adults entering IMT, and whether responses to Ca and vitamin D supplementation were modulated by genotype. Associations between SNPs, including vitamin D receptor (VDR), vitamin D binding protein (DBP), and 1-alpha-hydroxylase (CYP27B1), and circulating biomarkers were measured in fasting blood samples from volunteers (n = 748) starting IMT. Volunteers were block randomized by race and sex to receive Ca (2000 mg) and vitamin D (1000 IU) or placebo daily throughout Army or Air Force IMT (7 to 9 weeks). Total Ca and vitamin D intakes were calculated as the sum of supplemental intake based on intervention compliance and dietary intake. Relationships between SNPs, Ca, and vitamin D intake tertile and change in biomarkers were evaluated in trial completers (n = 391). At baseline, the minor allele of a DBP SNP (rs7041) was positively associated with both 25OHD (B = 4.46, p = 1.97E-10) and 1,25(OH) 2 D 3 (B = 9.63, p < 0.001). Combined genetic risk score (GRS) for this SNP and a second SNP in the VDR gene (rs1544410) was inversely associated with baseline 25OHD (r = -0.28, p < 0.001) and response to Ca and vitamin D intake differed by GRS (p < 0.05). In addition, presence of the minor allele of a second VDR SNP (rs2228570) was associated with lower P1NP (B = -4.83, p = 0.04) and osteocalcin (B = -0.59, p = 0.03). These data suggest that VDR and DBP SNPs are associated with 25OHD status and bone turnover and those with the highest GRS require the greatest vitamin D intake to improve 25OHD during IMT. © 2016 American Society for Bone and Mineral Research.",2017,"At baseline, the minor allele of a DBP SNP (rs7041) was positively associated with both 25OHD","['Young Adults Undergoing Military Training', '© 2016 American Society for Bone and Mineral Research']","['placebo', 'supplemental calcium (Ca) and vitamin D', 'Calcium and Vitamin D Supplementation', 'Ca (2000\u2009mg) and vitamin D', 'Initial military training (IMT', 'placebo daily throughout Army or Air Force IMT']","['Relationships between SNPs, Ca, and vitamin D intake tertile and change in biomarkers', '25OHD', 'response to Ca and vitamin D intake', 'stress fracture risk', 'Combined genetic risk score (GRS', '25OHD status and bone turnover', 'vitamin D receptor (VDR), vitamin D binding protein (DBP), and 1-alpha-hydroxylase (CYP27B1), and circulating biomarkers', 'stress fracture incidence, suppressed parathyroid hormone (PTH), and improved measures of bone health', 'Total Ca and vitamin D intakes']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0035168'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0564439', 'cui_str': 'Vitamin D intake (observable entity)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0016664', 'cui_str': 'Fractures, Fatigue'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0108082', 'cui_str': 'Cholecalciferol Receptors'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0242210', 'cui_str': 'Binding Proteins'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0020364', 'cui_str': 'Hydroxylases'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.13657,"At baseline, the minor allele of a DBP SNP (rs7041) was positively associated with both 25OHD","[{'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Gaffney-Stomberg', 'Affiliation': 'United States (US) Army Research Institute of Environmental Medicine, Natick, MA, USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Lutz', 'Affiliation': 'United States (US) Army Research Institute of Environmental Medicine, Natick, MA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Shcherbina', 'Affiliation': 'Massachusetts Institute for Technology Lincoln Laboratory, Lexington, MA, USA.'}, {'ForeName': 'Darrell O', 'Initials': 'DO', 'LastName': 'Ricke', 'Affiliation': 'Massachusetts Institute for Technology Lincoln Laboratory, Lexington, MA, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Petrovick', 'Affiliation': 'Massachusetts Institute for Technology Lincoln Laboratory, Lexington, MA, USA.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Cropper', 'Affiliation': 'Lackland Air Force Base, San Antonio, TX, USA.'}, {'ForeName': 'Sonya J', 'Initials': 'SJ', 'LastName': 'Cable', 'Affiliation': 'Initial Military Training Center of Excellence, Fort Eustis, VA, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'McClung', 'Affiliation': 'United States (US) Army Research Institute of Environmental Medicine, Natick, MA, USA.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3008'] 436,32412917,Effect of Prescription Tongxin on Endothelial Progenitor Cells in Peripheral Blood.,"Context Coronary heart disease (CHD) refers to a disease where coronary atherosclerosis induces stenosis or obstruction of the blood vessels. Endothelial progenitor cells (EPCs) function to protect and repair the vascular endothelium, and their functional activity state reflects the ability of the body to repair vascular damage. In the peripheral blood of patients with CHD, the density of EPCs decreases, and the function of EPCs is low. Objective This study aimed to investigate the effects of a China Food and Drug Administration (CFDA)-approved prescription medicine, Tongxin, on the density and function of endothelial progenitor cells (EPCs) in peripheral blood. Design In this study, a randomized, single blind, parallel controlled clinical trial was used. The single blind subjects were subjects. Setting The study took place in the Cardiology and Emergency Departments at Shanghai Municipal Hospital of Traditional Chinese Medicine in Shanghai, China. Participants Participants were 48 patients with coronary heart disease at the hospital. Intervention Participants were randomly divided into 2 groups (n = 24 each): a control group and an intervention group. Both groups received routine drug treatments, such as platelet inhibitors, nitrates, β-receptor blockers, statins, angiotensin-converting-enzyme (ACE) inhibitors, angiotensin II receptor antagonists (ARBs), and calcium blockers. The control group was treated with the Shexiang Baoxin Pill, while the intervention group was treated with prescription Tongxin. The course of treatment was 3 months for both groups. Outcome Measures Changes in the density and function of EPCs in the peripheral blood of the 2 groups were measured at baseline and postintervention, and the clinical efficacy of the 2 treatments was statistically analyzed. Results The density of EPCs was significantly higher in both groups after 3 months of treatment, compared to the densities at baseline (P < .05). The change in density between baseline and postintervention was significantly greater for the intervention group than for the control group (P < .05). For the control group, the proliferative vitality [optical density (OD)] value of the EPCs was significantly higher than that at baseline from the fourth day of treatment (P < .05). In the intervention group, the OD value was significantly higher than that at baseline from the first day of treatment (P < .05). Furthermore, the intervention group's cells began to enter the logarithmic growth phase of increase from the fifth day of treatment, and the group's increase as significantly higher than the control group's from the fifth to the seventh dayof treatment (P < .05 for all 3 days). Moreover, the total effective rate was higher in the intervention group than in the control group (P < .05). Conclusions Prescription Tongxin can stimulate the release of EPCs from the bone marrow to the peripheral blood of patients with CHD, can significantly increase the proliferation of EPCs in the peripheral blood, and can improve the clinical symptoms of patients. Its curative effect was greater than that of the control treatment.",2021,"Moreover, the total effective rate was higher in the intervention group than in the control group (P < .05). ","['Participants\n\n\nParticipants were 48 patients with coronary heart disease at the hospital', 'Setting\n\n\nThe study took place in the Cardiology and Emergency Departments at Shanghai Municipal Hospital of Traditional Chinese Medicine in Shanghai, China', 'Peripheral Blood']","['Shexiang Baoxin Pill', 'Prescription Tongxin', 'prescription Tongxin', 'control group and an intervention group', 'China Food and Drug Administration (CFDA)-approved prescription medicine, Tongxin', 'routine drug treatments, such as platelet inhibitors, nitrates, β-receptor blockers, statins, angiotensin-converting-enzyme (ACE) inhibitors, angiotensin II receptor antagonists (ARBs), and calcium blockers']","['proliferative vitality [optical density (OD)] value of the EPCs', 'OD value', 'change in density', 'total effective rate', 'clinical efficacy', 'density and function of EPCs in the peripheral blood', 'Endothelial Progenitor Cells', 'density of EPCs', 'proliferation of EPCs', 'Endothelial progenitor cells (EPCs) function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0020013', 'cui_str': 'Municipal Hospitals'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}]","[{'cui': 'C2351547', 'cui_str': 'shexiang baoxin'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032188', 'cui_str': 'Platelet Inhibitors'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0022709', 'cui_str': 'Dipeptidyl carboxypeptidase I'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}]","[{'cui': 'C0334094', 'cui_str': 'Proliferation'}, {'cui': 'C0439164', 'cui_str': 'OD units'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}]",48.0,0.0159673,"Moreover, the total effective rate was higher in the intervention group than in the control group (P < .05). ","[{'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Xue-Qin', 'Initials': 'XQ', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': ''}, {'ForeName': 'Xiao-Zhen', 'Initials': 'XZ', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Yi-Sheng', 'Initials': 'YS', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Qi-Mao', 'Initials': 'QM', 'LastName': 'Feng', 'Affiliation': ''}, {'ForeName': 'Li-Hua', 'Initials': 'LH', 'LastName': 'Lu', 'Affiliation': ''}]",Alternative therapies in health and medicine,[] 437,31563517,"Pegilodecakin combined with pembrolizumab or nivolumab for patients with advanced solid tumours (IVY): a multicentre, multicohort, open-label, phase 1b trial.","BACKGROUND IL-10 has anti-inflammatory and CD8+ T-cell stimulating activities. Pegilodecakin (pegylated IL-10) is a first-in-class, long-acting IL-10 receptor agonist that induces oligoclonal T-cell expansion and has single-agent activity in advanced solid tumours. We assessed the safety and activity of pegilodecakin with anti-PD-1 monoclonal antibody inhibitors in patients with advanced solid tumours. METHODS We did a multicentre, multicohort, open-label, phase 1b trial (IVY) at 12 cancer research centres in the USA. Patients were assigned sequentially into cohorts. Here, we report on all enrolled patients from two cohorts treated with pegilodecakin combined with anti-PD-1 inhibitors. Eligible patients were aged at least 18 years with histologically or cytologically confirmed advanced malignant solid tumours refractory to previous therapies, and an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients with uncontrolled infectious diseases were excluded. Pegilodecakin was provided in single-use 3 mL vials and was self-administered subcutaneously by injection at home at 10 μg/kg or 20 μg/kg once per day in combination with pembrolizumab (2 mg/kg every 3 weeks or 200 mg every 3 weeks) or nivolumab (3 mg/kg every 2 weeks or 240 mg every 2 weeks or 480 mg every 4 weeks at the approved dosing), both of which were given intravenously at the study site. Patients received pembrolizumab or nivolumab with pegilodecakin until disease progression, toxicity necessitating treatment discontinuation, patient withdrawal of consent, or study end. The primary endpoints were safety and tolerability, assessed in all patients enrolled in the study who received any amount of study medication including at least one dose of pegilodecakin, and pharmacokinetics (previously published). Secondary endpoints included objective response by immune-related response criteria in all patients who were treated and had evaluable measurements. The study is active but no longer recruiting, and is registered with ClinicalTrials.gov, NCT02009449. FINDINGS Between Feb 13, 2015, and Sept 12, 2017, 111 patients were enrolled in the two cohorts. 53 received pegilodecakin plus pembrolizumab, and 58 received pegilodecakin plus nivolumab. 34 (31%) of 111 patients had non-small-cell lung cancer, 37 (33%) had melanoma, and 38 (34%) had renal cell carcinoma; one (<1%) patient had triple-negative breast cancer and one (<1%) had bladder cancer. Data cutoff was July 1, 2018. Median follow-up was 26·9 months (IQR 22·3-31·5) for patients with non-small-cell lung cancer, 33·0 months (29·2-35·1) for those with melanoma, and 22·7 months (20·9-27·0) for those with renal cell carcinoma. At least one treatment-related adverse event occurred in 103 (93%) of 111 patients. Grade 3 or 4 events occurred in 73 (66%) of 111 patients (35 [66%] of 53 in the pembrolizumab group and 38 [66%] of 58 in the nivolumab group), the most common of which were anaemia (12 [23%] in the pembrolizumab group and 16 [28%] in the nivolumab group), thrombocytopenia (14 [26%] in the pembrolizumab group and 12 [21%] in the nivolumab group), fatigue (11 [21%] in the pembrolizumab group and 6 [10%] in the nivolumab group) and hypertriglyceridaemia (three [6%] in the pembrolizumab group and eight [14%] in the nivolumab group). There were no fatal adverse events determined to be related to the study treatments. Of the patients evaluable for response, objective responses were 12 (43%) of 28 (non-small-cell lung cancer), three (10%) of 31 (melanoma), and 14 (40%) of 35 (renal cell carcinoma). INTERPRETATION In this patient population, pegilodecakin with anti-PD-1 monoclonal antibodies had a manageable toxicity profile and preliminary antitumour activity. Pegilodecakin with pembrolizumab or nivolumab could provide a new therapeutic opportunity for previously treated patients with renal cell carcinoma and non-small-cell carcinoma. FUNDING ARMO BioSciences, a wholly owned subsidiary of Eli Lilly and Company.",2019,"Grade 3 or 4 events occurred in 73 (66%) of 111 patients (35 [66%] of 53 in the pembrolizumab group and 38 [66%] of 58 in the nivolumab group), the most common of which were anaemia (12 [23%] in the pembrolizumab group and 16 [28%] in the nivolumab group), thrombocytopenia (14 [26%] in the pembrolizumab group and 12 [21%] in the nivolumab group), fatigue (11 [21%] in the pembrolizumab group and 6 [10%] in the nivolumab group) and hypertriglyceridaemia (three [6%] in the pembrolizumab group and eight [14%] in the nivolumab group).","['Patients with uncontrolled infectious diseases', '111 patients were enrolled in the two cohorts', 'patients with advanced solid tumours (IVY', 'patients evaluable for response, objective responses were 12 (43%) of 28 (non-small-cell lung cancer), three (10%) of 31 (melanoma), and 14 (40%) of 35 (renal cell carcinoma', 'previously treated patients with renal cell carcinoma and non-small-cell carcinoma', 'Eligible patients were aged at least 18 years with histologically or cytologically confirmed advanced malignant solid tumours refractory to previous therapies, and an Eastern Cooperative Oncology Group performance status of 0 or 1', '12 cancer research centres in the USA', 'patients with advanced solid tumours']","['pegilodecakin plus nivolumab', 'pembrolizumab', 'pegilodecakin combined with anti-PD-1 inhibitors', 'pembrolizumab or nivolumab with pegilodecakin', 'Pegilodecakin combined with pembrolizumab or nivolumab', 'pegilodecakin with anti-PD-1 monoclonal antibody inhibitors', 'nivolumab', 'pegilodecakin plus pembrolizumab', 'Pegilodecakin (pegylated IL-10', 'Pegilodecakin', 'Pegilodecakin with pembrolizumab or nivolumab']","['Grade 3 or 4 events', 'thrombocytopenia', 'anaemia', 'fatal adverse events', 'bladder cancer', 'non-small-cell lung cancer', 'objective response by immune-related response criteria', 'renal cell carcinoma', 'adverse event', 'safety and activity', 'hypertriglyceridaemia', 'fatigue', 'safety and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1273849', 'cui_str': 'Infectious Diseases Specialty'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0446290', 'cui_str': 'Ivy (organism)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1266002', 'cui_str': 'Non-small cell carcinoma'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1698088', 'cui_str': 'Malignant solid tumour'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0035168'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",111.0,0.307663,"Grade 3 or 4 events occurred in 73 (66%) of 111 patients (35 [66%] of 53 in the pembrolizumab group and 38 [66%] of 58 in the nivolumab group), the most common of which were anaemia (12 [23%] in the pembrolizumab group and 16 [28%] in the nivolumab group), thrombocytopenia (14 [26%] in the pembrolizumab group and 12 [21%] in the nivolumab group), fatigue (11 [21%] in the pembrolizumab group and 6 [10%] in the nivolumab group) and hypertriglyceridaemia (three [6%] in the pembrolizumab group and eight [14%] in the nivolumab group).","[{'ForeName': 'Aung', 'Initials': 'A', 'LastName': 'Naing', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, USA. Electronic address: anaing@mdanderson.org.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Wong', 'Affiliation': 'David Geffen School of Medicine, TRIO-US, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Infante', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN, USA.'}, {'ForeName': 'W Michael', 'Initials': 'WM', 'LastName': 'Korn', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Raid', 'Initials': 'R', 'LastName': 'Aljumaily', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN, USA; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Kyriakos P', 'Initials': 'KP', 'LastName': 'Papadopoulos', 'Affiliation': 'START Center for Cancer Care, San Antonio, TX, USA.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Autio', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Shubham', 'Initials': 'S', 'LastName': 'Pant', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, USA; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Bauer', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Drakaki', 'Affiliation': 'David Geffen School of Medicine, TRIO-US, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Naval G', 'Initials': 'NG', 'LastName': 'Daver', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Hung', 'Affiliation': 'ARMO BioSciences, Redwood City, CA, USA.'}, {'ForeName': 'Navneet', 'Initials': 'N', 'LastName': 'Ratti', 'Affiliation': 'ARMO BioSciences, Redwood City, CA, USA; Synthkine, Menlo Park, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'McCauley', 'Affiliation': 'ARMO BioSciences, Redwood City, CA, USA; Synthkine, Menlo Park, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Van Vlasselaer', 'Affiliation': 'ARMO BioSciences, Redwood City, CA, USA.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Verma', 'Affiliation': 'ARMO BioSciences, Redwood City, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ferry', 'Affiliation': 'Eli Lilly and Company, New York City, NY, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Oft', 'Affiliation': 'ARMO BioSciences, Redwood City, CA, USA; Synthkine, Menlo Park, USA.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Diab', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Edward B', 'Initials': 'EB', 'LastName': 'Garon', 'Affiliation': 'David Geffen School of Medicine, TRIO-US, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Nizar M', 'Initials': 'NM', 'LastName': 'Tannir', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30514-5'] 438,28089606,Parasacral transcutaneous electrical neural stimulation (PTENS) once a week for the treatment of overactive bladder in children: A randomized controlled trial.,"INTRODUCTION Overactive bladder (OAB) is the most prevalent voiding disorder in childhood, and its main manifestation is urinary urgency. In general, urotherapy and anticholinergics are the first choices of treatment. Parasacral Transcutaneous Electrical Neural Stimulation (PTENS) was introduced as an alternative for the treatment of detrusor overactivity in children, but treatment protocols described to date require several sessions per week or long-lasting sessions, making it difficult for the child to adhere to the treatment. Thus, this study aims to evaluate the effectiveness of PTENS in single weekly sessions in the treatment of OAB in children. STUDY DESIGN This prospective, randomized controlled trial included 16 children with OAB. Children were divided into two groups: CG (urotherapy and electrical stimulation placebo) and EG (urotherapy and PTENS). For both groups, therapy was delivered in 20 weekly sessions, of duration 20 min each. Placebo electrical stimulation was done in the scapular area. The children were evaluated prior to treatment (T1), at the end of the 20 sessions (T2), and 60 days after the completion of treatment (T3), with a 3-day voiding diary, visual analogue scale (VAS), Rome III diagnostic criteria, and the Bristol Scale. RESULTS The groups were similar in age, gender, and ethnicity. In the initial assessment, all children, in both groups, had urgency and incontinence, 50% in each group had constipation, and enuresis was present in seven children (87.5%) in the EG and six (75%) in the CG. No differences were found between the groups regarding the volumetric measurements made in the voiding diary, urinary frequency and constipation evaluated by the Rome III criteria and the Bristol Scale. Sixty days after treatment, a significant improvement was found in the EG group (p = 0.03) regarding urgency (Table), as well as an increase in dry nights in those presenting with enuresis (p = 0.03). No difference was noted regarding urinary incontinence (Table). At the end of 20 sessions and after 60 days of treatment, those responsible for the children in the EG perceived greater improvement in symptoms measured by the VAS (p = 0.05 and 0.04, respectively). CONCLUSIONS Our preliminary results demonstrate that PTENS performed in single weekly sessions is effective in treating the bladder for symptoms of urinary urgency and enuresis, and in the perception of those responsible for the children. Further studies with larger populations are needed to corroborate these results.",2017,"No differences were found between the groups regarding the volumetric measurements made in the voiding diary, urinary frequency and constipation evaluated by the Rome III criteria and the Bristol Scale.","['16 children with OAB', 'OAB in children', 'overactive bladder in children']","['Parasacral Transcutaneous Electrical Neural Stimulation (PTENS', 'Placebo electrical stimulation', 'PTENS', 'Parasacral transcutaneous electrical neural stimulation (PTENS', 'CG (urotherapy and electrical stimulation placebo) and EG (urotherapy and PTENS']","['3-day voiding diary, visual analogue scale (VAS), Rome III diagnostic criteria, and the Bristol Scale', 'voiding diary, urinary frequency and constipation evaluated by the Rome III criteria and the Bristol Scale', 'dry nights', 'urgency and incontinence', 'urinary incontinence (Table', 'constipation, and enuresis']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}]","[{'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0222045'}, {'cui': 'C0042023', 'cui_str': 'Increased frequency of urination (finding)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C1706074', 'cui_str': 'Table'}, {'cui': 'C0403670', 'cui_str': 'Urinary incontinence of non-organic origin (finding)'}]",16.0,0.0253862,"No differences were found between the groups regarding the volumetric measurements made in the voiding diary, urinary frequency and constipation evaluated by the Rome III criteria and the Bristol Scale.","[{'ForeName': 'Lidyanne Ilidia da Silva', 'Initials': 'LIDS', 'LastName': 'de Paula', 'Affiliation': 'Division of Urology, Department of Surgery, Federal University of Juiz de Fora (UFJF), MG, Brazil.'}, {'ForeName': 'Liliana Fajardo', 'Initials': 'LF', 'LastName': 'de Oliveira', 'Affiliation': 'Division of Urology, Department of Surgery, Federal University of Juiz de Fora (UFJF), MG, Brazil.'}, {'ForeName': 'Brysa Paiva', 'Initials': 'BP', 'LastName': 'Cruz', 'Affiliation': 'Division of Urology, Department of Surgery, Federal University of Juiz de Fora (UFJF), MG, Brazil.'}, {'ForeName': 'Dayana Maria', 'Initials': 'DM', 'LastName': 'de Oliveira', 'Affiliation': 'Division of Urology, Department of Surgery, Federal University of Juiz de Fora (UFJF), MG, Brazil.'}, {'ForeName': 'Laís Maini', 'Initials': 'LM', 'LastName': 'Miranda', 'Affiliation': 'Division of Urology, Department of Surgery, Federal University of Juiz de Fora (UFJF), MG, Brazil.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'de Moraes Ribeiro', 'Affiliation': 'Division of Urology, Department of Surgery, Federal University of Juiz de Fora (UFJF), MG, Brazil.'}, {'ForeName': 'Raphaela Ornellas', 'Initials': 'RO', 'LastName': 'Duque', 'Affiliation': 'Division of Urology, Department of Surgery, Federal University of Juiz de Fora (UFJF), MG, Brazil.'}, {'ForeName': 'André Avarese', 'Initials': 'AA', 'LastName': 'de Figueiredo', 'Affiliation': 'Division of Urology, Department of Surgery, Federal University of Juiz de Fora (UFJF), MG, Brazil.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'de Bessa', 'Affiliation': 'Division of Urology, Department of Surgery, State University of Feira de Santana (UEFS), BA, Brazil.'}, {'ForeName': 'José Murillo Bastos', 'Initials': 'JMB', 'LastName': 'Netto', 'Affiliation': 'Division of Urology, Department of Surgery, Federal University of Juiz de Fora (UFJF), MG, Brazil; Division of Urology, Department of Surgery, Hospital and Maternity Therezinha de Jesus da Faculdade de Ciências Médicas e da Saúde de Juiz de For a (HMTJ/Suprema), MG, Brazil. Electronic address: jose.murillo@ufjf.edu.br.'}]",Journal of pediatric urology,['10.1016/j.jpurol.2016.11.019'] 439,32412916,Binaural Beats Reduce Postoperative Morphine Consumption in Older adults After Total Knee Replacement Surgery.,"Context A reduction in the use of opioids by older adult patients could reduce unpleasant side effects for them. During general anesthesia, binaural beat (BB) listening has been found to reduce intraoperative fentanyl consumption as well as postoperative pain scores and discharge time. Auditory BBs are a perceptual phenomenon occurring when tones of 2 slightly different frequencies are presented simultaneously and separately to each ear. Objective The study intended to evaluate the ability of BBs, as a nonpharmacological premedication, to reduce postoperative morphine consumption in older adults undergoing total knee replacement surgery and to modify the levels of anxiety and feelings of pain that patients experience. Design The research team designed a prospective, single-center, randomized controlled study. Setting The study was conducted in the Orthopedic Department of the Santa Maria Maddalena Hospital (Volterra [Pisa], Italy). Participants Forty older adults at the hospital who were undergoing total knee joint replacement with spinal anesthesia participated in the study. Intervention The study included 2 groups (n = 20 each), one receiving BBs stimulation with frequencies of 256 Hz in one ear and 260 Hz in the opposite ear producing a BB of 4 Hz (intervention group), and the other receiving acoustical stimulation at 256 Hz in both ears (control group). BBs, or acoustical stimulation, were administered before the surgical procedure. Both acoustical stimuli, generated with the Gnaural program, were delivered through stereo headphones connected to a laptop in the preoperative holding area. Outcome Measures The study measured postoperative, cumulative, self-administered morphine consumption, in mg, through a patient-controlled analgesia device. Feelings of anxiety were also assessed using the State-Trait Anxiety Inventory, and feelings of pain were measured every 8 h during the first postoperative day using a numerical rating scale. Results Patients who received the intervention, consumed almost half of the dosage of morphine during the first postoperative day when compared with the control group's consumption, 5.75 mg ± 5.25 vs 11.85 mg ± 7.71, respectively. The consumption did not correlate to anxiety measures. Regarding pain perception, no differences between the groups were captured. Conclusions BB stimulation before surgery can be successfully used as a nonpharmacological treatment to reduce morphine consumption in older adults who undergo knee replacement. The use of a noninvasive, safe, and inexpensive BB intervention can result in a positive effect on patients' postoperative recovery.",2021,"Regarding pain perception, no differences between the groups were captured. ","['Participants\n\n\nForty older adults at the hospital who were undergoing total knee joint replacement with spinal anesthesia participated in the study', '2 groups (n = 20 each), one receiving BBs stimulation with frequencies of 256 Hz in one ear and 260 Hz in the opposite ear producing a BB of 4 Hz (intervention group), and the other receiving acoustical stimulation at 256 Hz in both ears (control group', 'older adults who undergo knee replacement', 'Orthopedic Department of the Santa Maria Maddalena Hospital (Volterra [Pisa], Italy', 'older adults undergoing total knee replacement surgery', 'Older adults', 'older adult patients', 'After Total Knee Replacement Surgery']","['general anesthesia, binaural beat (BB) listening', 'inexpensive BB intervention', 'morphine']","['Feelings of anxiety', 'BBs, or acoustical stimulation', 'anxiety and feelings of pain', 'State-Trait Anxiety Inventory, and feelings of pain', 'unpleasant side effects', 'postoperative pain scores and discharge time', 'pain perception', 'postoperative, cumulative, self-administered morphine consumption, in mg, through a patient-controlled analgesia device']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0376249', 'cui_str': 'Frequency'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0229300', 'cui_str': 'Both ears'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0587525', 'cui_str': 'Orthopedic department'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]",40.0,0.0762104,"Regarding pain perception, no differences between the groups were captured. ","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Tani', 'Affiliation': ''}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Vagheggini', 'Affiliation': ''}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Moretti', 'Affiliation': ''}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Del Colombo', 'Affiliation': ''}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Lehle', 'Affiliation': ''}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Campana', 'Affiliation': ''}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Labate', 'Affiliation': ''}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Tomaiuolo', 'Affiliation': ''}]",Alternative therapies in health and medicine,[] 440,32413002,Baseline and Clinical Factors Associated with Response to Amblyopia Treatment in a Randomized Clinical Trial.,"SIGNIFICANCE We sought to identify baseline and clinical factors that were predictive of the response to amblyopia treatment. We report that binocular amblyopia treatment may be especially effective for moderate amblyopia in orthotropic children. PURPOSE We previously reported results from the primary cohort (n = 28) enrolled in a randomized clinical trial (NCT02365090), which found that binocular amblyopia treatment was more effective than patching. Enrollment of an additional 20 children was pre-planned to provide the opportunity to examine factors that may be predictive of response to amblyopia treatment. METHODS Forty-eight children (4 to 10 years old) were enrolled, with 24 randomized to contrast-rebalanced binocular game treatment (1 hour a day, 5 days a week) and 24 to patching treatment (2 hours a day, 7 days a week). The primary outcome was change in amblyopic eye best-corrected visual acuity at the 2-week visit. Baseline factors examined were age at enrollment, visual acuity, stereoacuity, and suppression. Clinical factors were etiology, age at diagnosis, prior treatment, and ocular alignment. RESULTS At 2 weeks, visual acuity improvement was significantly greater with the binocular game than patching. Children with moderate amblyopia and orthotropia had more visual acuity improvement with binocular game play than did those with severe amblyopia. In addition, children who spent more time playing the binocular game had more improvement. We were not able to confidently identify any baseline or clinical factors that were associated with response to patching treatment. CONCLUSIONS Binocular amblyopia treatment was more effective among orthotropic children with moderate amblyopia than among children with microtropia or severe amblyopia.",2020,"At 2 weeks, visual acuity improvement was significantly greater with the binocular game than patching.","['orthotropic children with moderate amblyopia than among children with microtropia or severe amblyopia', 'Children with moderate amblyopia and orthotropia', 'Forty-eight children (4 to 10 years old']","['binocular amblyopia treatment', 'Binocular amblyopia treatment', 'contrast-rebalanced binocular game treatment']","['change in amblyopic eye best-corrected visual acuity', 'visual acuity, stereoacuity, and suppression', 'visual acuity improvement', 'time playing the binocular game']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0271356', 'cui_str': 'Microstrabismus'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1275505', 'cui_str': 'Stereoscopic acuity'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}]",48.0,0.177459,"At 2 weeks, visual acuity improvement was significantly greater with the binocular game than patching.","[{'ForeName': 'Eileen E', 'Initials': 'EE', 'LastName': 'Birch', 'Affiliation': ''}, {'ForeName': 'Reed M', 'Initials': 'RM', 'LastName': 'Jost', 'Affiliation': 'Retina Foundation of the Southwest, Dallas, Texas.'}, {'ForeName': 'Krista R', 'Initials': 'KR', 'LastName': 'Kelly', 'Affiliation': 'Retina Foundation of the Southwest, Dallas, Texas.'}, {'ForeName': 'Joel N', 'Initials': 'JN', 'LastName': 'Leffler', 'Affiliation': ""Children's Eye Care of North Texas, PA, Plano, Texas.""}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Dao', 'Affiliation': 'ABC Eyes Pediatric Ophthalmology, PA, Dallas, Texas.'}, {'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Beauchamp', 'Affiliation': 'ABC Eyes Pediatric Ophthalmology, PA, Dallas, Texas.'}]",Optometry and vision science : official publication of the American Academy of Optometry,['10.1097/OPX.0000000000001514'] 441,27943220,Population Pharmacokinetics and Exploratory Pharmacodynamics of Lorazepam in Pediatric Status Epilepticus.,"BACKGROUND Lorazepam is one of the preferred agents used for intravenous treatment of status epilepticus (SE). We combined data from two pediatric clinical trials to characterize the population pharmacokinetics of intravenous lorazepam in infants and children aged 3 months to 17 years with active SE or a history of SE. METHODS We developed a population pharmacokinetic model for lorazepam using the NONMEM software. We then assessed exploratory exposure-response relationships using the overall efficacy and safety study endpoints, and performed dosing simulations. RESULTS A total of 145 patients contributed 439 pharmacokinetic samples. The median (range) age and dose were 5.4 years (0.3-17.8) and 0.10 mg/kg (0.02-0.18), respectively. A two-compartment pharmacokinetic model with allometric scaling described the data well. In addition to total body weight (WT), younger age was associated with slightly higher weight-normalized clearance (CL). The following relationships characterized the typical values for the central compartment volume (V1), CL, peripheral compartment volume (V2), and intercompartmental CL (Q), using individual subject WT (kg) and age (years): V1 (L) = 0.879*WT; CL (L/h) = 0.115*(Age/4.7) 0.133 *WT 0.75 ; V2 (L) = 0.542*V1; Q (L/h) = 1.45*WT 0.75 . No pharmacokinetic parameters were associated with clinical outcomes. Simulations suggest uniform pediatric dosing (0.1 mg/kg, to a maximum of 4 mg) can be used to achieve concentrations of 50-100 ng/mL in children with SE, which have been previously associated with effective seizure control. CONCLUSIONS The population pharmacokinetics of lorazepam were successfully described using a sparse sampling approach and a two-compartment model in pediatric patients with active SE.",2017,No pharmacokinetic parameters were associated with clinical outcomes.,"['pediatric patients with active SE', 'infants and children aged 3\xa0months to 17\xa0years with active SE or a history of SE', 'Pediatric Status Epilepticus', '145 patients contributed 439 pharmacokinetic samples']","['Lorazepam', 'lorazepam']","['weight-normalized clearance (CL', 'central compartment volume (V1), CL, peripheral compartment volume (V2), and intercompartmental CL (Q']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0038220', 'cui_str': 'Status Epilepticus, Generalized'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0024002', 'cui_str': 'Lorazepam'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}]",,0.118065,No pharmacokinetic parameters were associated with clinical outcomes.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gonzalez', 'Affiliation': 'Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Chamberlain', 'Affiliation': ""Division of Emergency Medicine, Children's National Medical Center, Washington, DC, USA.""}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Guptill', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cohen-Wolkowiez', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Barrie', 'Initials': 'B', 'LastName': 'Harper', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Emmes Corporation, Rockville, MD, USA.'}, {'ForeName': 'Edmund V', 'Initials': 'EV', 'LastName': 'Capparelli', 'Affiliation': 'Department of Pediatrics and Skaggs School of Pharmacy, University of California, San Diego, 9500 Gilman Drive, La Jolla, CA, 92093-0831, USA. ecapparelli@ucsd.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical pharmacokinetics,['10.1007/s40262-016-0486-0'] 442,27483410,Improvement of High-Density Lipoprotein Function in Patients With Early Rheumatoid Arthritis Treated With Methotrexate Monotherapy or Combination Therapies in a Randomized Controlled Trial.,"OBJECTIVE Abnormal function of high-density lipoprotein (HDL) has been implicated as a potential mechanism for the increased incidence of cardiovascular (CV) disease in patients with rheumatoid arthritis (RA). This study was undertaken to evaluate changes in HDL function and HDL-associated proteins over 2 years of follow-up in patients with early RA receiving either methotrexate (MTX) monotherapy, MTX + etanercept (ETN) combination therapy, or MTX + sulfasalazine (SSZ) + hydroxychloroquine (HCQ) triple therapy in the Treatment of Early Aggressive Rheumatoid Arthritis (TEAR) trial. METHODS The antioxidant capacity of HDL, paraoxonase 1 (PON-1) activity, and levels of HDL-associated haptoglobin (Hp), HDL-associated apolipoprotein A-I (Apo A-I), and myeloperoxidase (MPO) were measured in 550 TEAR participants at 4 time points (time 0 [pretreatment] and at 24, 48, and 102 weeks of treatment). Repeated-measures analysis using mixed-effects linear models with an autoregressive covariate structure was performed to model the within-subject covariance over time. RESULTS Mixed-effects models, which were controlled for traditional CV risk factors, treatment regimen, prednisone use, and statin use, demonstrated significant associations between RA disease activity, measured using the Disease Activity Score in 28 joints, erythrocyte sedimentation rate, or C-reactive protein level, and the profile of HDL function over time. Specifically, decreases in RA disease activity over time were associated with increases in PON-1 activity and levels of HDL-associated Apo A-I, and decreases in the HDL inflammatory index and levels of MPO and HDL-associated Hp. CONCLUSION Reduced disease activity in patients with early RA treated with MTX monotherapy, MTX + ETN combination therapy, or MTX + SSZ + HCQ triple therapy in the TEAR trial was associated with improvements in the HDL function profile. Additional studies are warranted to evaluate abnormal HDL function as a potential mechanism and therapeutic target for CV risk in patients with RA.",2017,"The antioxidant capacity of HDL, paraoxonase 1 (PON-1) activity, and levels of HDL-associated haptoglobin (Hp), HDL-associated apolipoprotein A-I (Apo A-I), and myeloperoxidase (MPO) were measured in 550 TEAR participants at 4 time points (time 0 [pretreatment] and at 24, 48, and 102 weeks of treatment).","['patients with early RA treated with', 'patients with rheumatoid arthritis (RA', 'patients with early RA receiving either', 'Patients', 'patients with RA']","['MTX\u2009+\u2009SSZ\u2009+\u2009HCQ triple therapy', 'MTX monotherapy, MTX', 'high-density lipoprotein (HDL', 'methotrexate (MTX) monotherapy, MTX\u2009+\u2009etanercept (ETN) combination therapy, or MTX\u2009+\u2009sulfasalazine (SSZ)\u2009+\u2009hydroxychloroquine (HCQ) triple therapy', 'Methotrexate Monotherapy']","['RA disease activity', 'cardiovascular (CV) disease', 'PON-1 activity and levels of HDL-associated Apo A-I', 'HDL inflammatory index and levels of MPO and HDL-associated Hp', 'Disease Activity Score in 28 joints, erythrocyte sedimentation rate, or C-reactive protein level, and the profile of HDL function', 'antioxidant capacity of HDL, paraoxonase 1 (PON-1) activity, and levels of HDL-associated haptoglobin (Hp), HDL-associated apolipoprotein A-I (Apo A-I), and myeloperoxidase (MPO', 'HDL function profile', 'disease activity', 'High-Density Lipoprotein Function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}]","[{'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0036078', 'cui_str': 'Sulfasalazine'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0032639', 'cui_str': 'Pons Varolii'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0622790', 'cui_str': 'Apo A-I (Giessen)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0912079', 'cui_str': 'myelopoietin'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C1121571', 'cui_str': 'Paraoxonase 1'}, {'cui': 'C0919773', 'cui_str': 'Haptoglobin'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}]",550.0,0.0472934,"The antioxidant capacity of HDL, paraoxonase 1 (PON-1) activity, and levels of HDL-associated haptoglobin (Hp), HDL-associated apolipoprotein A-I (Apo A-I), and myeloperoxidase (MPO) were measured in 550 TEAR participants at 4 time points (time 0 [pretreatment] and at 24, 48, and 102 weeks of treatment).","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Charles-Schoeman', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Yuen', 'Initials': 'Y', 'LastName': 'Yin Lee', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Ani', 'Initials': 'A', 'LastName': 'Shahbazian', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Elashoff', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Curtis', 'Affiliation': 'University of Alabama at Birmingham.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Navarro-Millán', 'Affiliation': 'University of Alabama at Birmingham.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'University of Alabama at Birmingham.'}, {'ForeName': 'Lang', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'University of Alabama at Birmingham.'}, {'ForeName': 'Stacey S', 'Initials': 'SS', 'LastName': 'Cofield', 'Affiliation': 'University of Alabama at Birmingham.'}, {'ForeName': 'Larry W', 'Initials': 'LW', 'LastName': 'Moreland', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Paulus', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': ""O'Dell"", 'Affiliation': 'University of Nebraska Medical Center, Omaha.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Bathon', 'Affiliation': 'Columbia University, New York, New York.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Louis Bridges', 'Affiliation': 'University of Alabama at Birmingham.'}, {'ForeName': 'Srinivasa T', 'Initials': 'ST', 'LastName': 'Reddy', 'Affiliation': 'University of California, Los Angeles.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.39833'] 443,31752969,Delivery of home-based postpartum contraception in rural Guatemalan women: a cluster-randomized trial protocol.,"BACKGROUND Postpartum contraception is important to prevent unintended and closely spaced pregnancies following childbirth. METHODS This study is a cluster-randomized trial of communities in rural Guatemala where women receive ante- and postnatal care through a community-based nursing program. When nurses visit women for their postpartum visit in the intervention clusters, instead of providing only routine care that includes postpartum contraceptive education and counseling, the nurses will also bring a range of barrier, short-acting, and long-acting contraceptives that will be offered and administered in the home setting, after routine clinical care is provided. DISCUSSION A barrier to postpartum contraception is access to medications and devices. Our study removes some access barriers (distance, time, cost) by providing contraception in the home. We also trained community nurses to place implants, which are a type of long-acting reversible contraceptive method that was previously only available in the closest town which is about an hour away by vehicular travel. Therefore, our study examines how home-based delivery of routinely available contraceptives and the less routinely available implant may be associated with increased uptake of postpartum contraception within 3 months of childbirth. The potential implications of this study include that nurses may be able to be trained to safely provide contraceptives, including placing implants, in the home setting, and provision of home-based contraception may be an effective way of delivering an evidence-based intervention for preventing unintended and closely spaced pregnancies in the postpartum period. TRIAL REGISTRATION Clinicaltrials.gov, NCT04005391. Retrospectively registered on 1 July 2019.",2019,"When nurses visit women for their postpartum visit in the intervention clusters, instead of providing only routine care that includes postpartum contraceptive education and counseling, the nurses will also bring a range of barrier, short-acting, and long-acting contraceptives that will be offered and administered in the home setting, after routine clinical care is provided. ","['communities in rural Guatemala where women receive ante- and postnatal care through a community-based nursing program', 'rural Guatemalan women']",['home-based postpartum contraception'],[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0032782', 'cui_str': 'Postpartum Care'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0700589', 'cui_str': 'Fertility Control'}]",[],,0.184952,"When nurses visit women for their postpartum visit in the intervention clusters, instead of providing only routine care that includes postpartum contraceptive education and counseling, the nurses will also bring a range of barrier, short-acting, and long-acting contraceptives that will be offered and administered in the home setting, after routine clinical care is provided. ","[{'ForeName': 'Margo S', 'Initials': 'MS', 'LastName': 'Harrison', 'Affiliation': 'University of Colorado, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, Denver, CO, 80045, USA. margo.harrison@ucdenver.edu.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Bunge-Montes', 'Affiliation': 'Fundación para la Salud Integral de los Guatemaltecos (FSIG), Quetzaltenango, Guatemala.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Rivera', 'Affiliation': 'Fundación para la Salud Integral de los Guatemaltecos (FSIG), Quetzaltenango, Guatemala.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Jimenez-Zambrano', 'Affiliation': 'University of Colorado, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, Denver, CO, 80045, USA.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Heinrichs', 'Affiliation': 'Denver Health, Denver, CO, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Scarbro', 'Affiliation': 'University of Colorado, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, Denver, CO, 80045, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Juarez-Colunga', 'Affiliation': 'University of Colorado, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, Denver, CO, 80045, USA.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Bolanos', 'Affiliation': 'Fundación para la Salud Integral de los Guatemaltecos (FSIG), Quetzaltenango, Guatemala.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Asturias', 'Affiliation': 'University of Colorado, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, Denver, CO, 80045, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Berman', 'Affiliation': 'University of Colorado, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, Denver, CO, 80045, USA.'}, {'ForeName': 'Jeanelle', 'Initials': 'J', 'LastName': 'Sheeder', 'Affiliation': 'University of Colorado, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, Denver, CO, 80045, USA.'}]",Trials,['10.1186/s13063-019-3735-3'] 444,32415533,Introducing 'Predictive Parenting': A Feasibility Study of a New Group Parenting Intervention Targeting Emotional and Behavioral Difficulties in Children with Autism Spectrum Disorder.,"Parent-mediated interventions can reduce behavioral and emotional problems in children with ASD. This report discusses the development of the first group parent intervention targeting behaviors and anxiety in children with ASD, across the spectrum of cognitive and language ability. 'Predictive Parenting' was developed from the clinical observation (and emerging evidence base) that children with ASD struggle with 'prediction' and anticipating change. It integrates well-established parenting strategies within an ASD-specific framework. The concept was co-created with patient and public involvement panels of parents and adults with ASD. A feasibility study found the programme is acceptable and accessible. Qualitative feedback from participants was largely positive, and critiques were used to inform a larger, pilot randomized controlled trial of the intervention.",2021,"This report discusses the development of the first group parent intervention targeting behaviors and anxiety in children with ASD, across the spectrum of cognitive and language ability. '","['Children with Autism Spectrum Disorder', 'children with ASD', ""Introducing 'Predictive Parenting""]",['New Group Parenting Intervention'],['behavioral and emotional problems'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}, {'cui': 'C1292748', 'cui_str': 'Introduces'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0677660', 'cui_str': 'Emotional problems'}]",,0.0708181,"This report discusses the development of the first group parent intervention targeting behaviors and anxiety in children with ASD, across the spectrum of cognitive and language ability. '","[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Hallett', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK. Victoria.hallett@slam.nhs.uk.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Mueller', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Breese', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Hollett', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Beresford', 'Affiliation': 'Social Policy Research Unit, University of York, York, UK.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Irvine', 'Affiliation': 'Social Policy Research Unit, University of York, York, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Pickles', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Slonims', 'Affiliation': ""Newcomen Neurodevelopmental Centre, Children's Neurosciences, Evelina Children's Hospital, Guy's and St Thomas NHS Foundation, London, UK.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Scott', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Charman', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Simonoff', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04442-2'] 445,32413530,Cranberry capsules are not superior to placebo capsules in managing acute non-haemorrhagic radiation cystitis in prostate cancer patients: A phase III double blinded randomised placebo controlled clinical trial.,"PURPOSE Acute radiation cystitis affects the quality of life of many prostate cancer patients. A previous pilot study suggested that cranberry capsules may decrease some of the symptoms of acute radiation cystitis. Here we further test their effectiveness in a multicentre double blinded placebo-controlled clinical trial. MATERIAL AND METHODS A total of 108 prostate cancer patients were recruited at three New Zealand hospitals between September 2016 and January 2019. Out of this cohort, 101 patients provided datasets for analysis (51 men on cranberry capsules and 50 men on beetroot-containing placebo capsules). Patients took two capsules each morning during RT and for 2 weeks after completion of RT. Three measures were used to assess cystitis severity: modified RTOG, O'Leary interstitial cystitis scale and a sensitive novel radiation induced cystitis assessment scale (RICAS). Cystitis severity was scored at baseline and weekly thereafter during RT and for two weeks after completion of RT. Radiation protocols were stratified to conventional fractionation or hypo-fractionated radiation therapy (CHHiP) to the prostate or radiation to the prostate bed. RESULTS Cranberry capsules performed significantly worse than placebo capsules with respect to day time frequency and bladder control, using the more sensitive RICAS scale. No significant difference in cystitis severity was seen between patients receiving hypofractionation and those receiving conventional fractionation to the prostate gland. CONCLUSION Cranberry capsules were not superior to beetroot-containing placebo capsules in managing radiation cystitis in our prostate patient cohort. RICAS may be a useful tool for measuring radiation cystitis in future studies.",2020,"No significant difference in cystitis severity was seen between patients receiving hypofractionation and those receiving conventional fractionation to the prostate gland. ","['101 patients provided datasets for analysis (51 men on cranberry capsules and 50 men on beetroot-containing placebo capsules', 'many prostate cancer patients', 'prostate cancer patients', '108 prostate cancer patients were recruited at three New Zealand hospitals between September 2016 and January 2019']","['conventional fractionation or hypo-fractionated radiation therapy (CHHiP', 'Cranberry capsules', 'placebo capsules', 'RICAS', 'cranberry capsules', 'placebo']","['Cystitis severity', 'sensitive RICAS scale', 'symptoms of acute radiation cystitis', 'cystitis severity', ""cystitis severity: modified RTOG, O'Leary interstitial cystitis scale and a sensitive novel radiation induced cystitis assessment scale (RICAS""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0453112', 'cui_str': 'Beetroot'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0524811', 'cui_str': 'Dose Fractionation, Radiotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}]","[{'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0403637', 'cui_str': 'Acute radiation cystitis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0282488', 'cui_str': 'Ulcerative cystitis'}, {'cui': 'C0205314', 'cui_str': 'New'}]",108.0,0.254135,"No significant difference in cystitis severity was seen between patients receiving hypofractionation and those receiving conventional fractionation to the prostate gland. ","[{'ForeName': 'Patries M', 'Initials': 'PM', 'LastName': 'Herst', 'Affiliation': 'Department of Radiation Therapy, University of Otago, Wellington, New Zealand. Electronic address: patries.herst@otago.ac.nz.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Aumata', 'Affiliation': 'Radiation Oncology Department, Southern Blood and Cancer Centre, Dunedin Hospital, New Zealand.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Sword', 'Affiliation': 'Kathleen Kilgour Centre, Tauranga, New Zealand.'}, {'ForeName': 'Rowan', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Auckland Radiation Oncology, Epsom, New Zealand.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Purdie', 'Affiliation': ""Dean's Department, University of Otago, Wellington, New Zealand.""}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Costello', 'Affiliation': 'Radiation Oncology Department, Southern Blood and Cancer Centre, Dunedin Hospital, New Zealand.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.05.006'] 446,32414376,Implementation and adoption of a health insurance support tool in the electronic health record: a mixed methods analysis within a randomized trial.,"BACKGROUND In addition to delivering vital health care to millions of patients in the United States, community health centers (CHCs) provide needed health insurance outreach and enrollment support to their communities. We developed a health insurance enrollment tracking tool integrated within the electronic health record (EHR) and conducted a hybrid implementation-effectiveness trial in a CHC-based research network to assess tool adoption using two implementation strategies. METHODS CHCs were recruited from the OCHIN practice-based research network. Seven health center systems (23 CHC clinic sites) were recruited and randomized to receive basic educational materials alone (Arm 1), or these materials plus facilitation (Arm 2) during the 18-month study period, September 2016-April 2018. Facilitation consisted of monthly contacts with clinic staff and utilized audit and feedback and guided improvement cycles. We measured total and monthly tool utilization from the EHR. We conducted structured interviews of CHC staff to assess factors associated with tool utilization. Qualitative data were analyzed using an immersion-crystallization approach with barriers and facilitators identified using the Consolidated Framework for Implementation Research. RESULTS The majority of CHCs in both study arms adopted the enrollment tool. The rate of tool utilization was, on average, higher in Arm 2 compared to Arm 1 (20.0% versus 4.7%, p < 0.01). However, by the end of the study period, the rate of tool utilization was similar in both arms; and observed between-arm differences in tool utilization were largely driven by a single, large health center in Arm 2. Perceived relative advantage of the tool was the key factor identified by clinic staff as driving tool utilization. Implementation climate and leadership engagement were also associated with tool utilization. CONCLUSIONS Using basic education materials and low-intensity facilitation, CHCs quickly adopted an EHR-based tool to support critical outreach and enrollment activities aimed at improving access to health insurance in their communities. Though facilitation carried some benefit, a CHC's perceived relative advantage of the tool was the primary driver of decisions to implement the tool. TRIAL REGISTRATION ClinicalTrials.gov: NCT02355262, Posted February 4, 2015.",2020,"The rate of tool utilization was, on average, higher in Arm 2 compared to Arm 1 (20.0% versus 4.7%, p < 0.01).","['Seven health center systems (23 CHC clinic sites', 'CHCs were recruited from the OCHIN practice-based research network']","['health insurance enrollment tracking tool integrated within the electronic health record (EHR', 'basic educational materials alone']",['rate of tool utilization'],"[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1861453', 'cui_str': 'Pseudohyperkalemia Cardiff'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.135831,"The rate of tool utilization was, on average, higher in Arm 2 compared to Arm 1 (20.0% versus 4.7%, p < 0.01).","[{'ForeName': 'Brigit', 'Initials': 'B', 'LastName': 'Hatch', 'Affiliation': 'Oregon Health & Science University, 3405 SW Perimeter Court, Portland, OR, 97239, USA. adamusb@ohsu.edu.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Tillotson', 'Affiliation': 'OCHIN, 1881 SW Naito Parkway, Portland, OR, 97201, USA.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Huguet', 'Affiliation': 'Oregon Health & Science University, 3405 SW Perimeter Court, Portland, OR, 97239, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Marino', 'Affiliation': 'Oregon Health & Science University, 3405 SW Perimeter Court, Portland, OR, 97239, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Baron', 'Affiliation': 'Oregon Health & Science University, 3405 SW Perimeter Court, Portland, OR, 97239, USA.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Nelson', 'Affiliation': 'OCHIN, 1881 SW Naito Parkway, Portland, OR, 97201, USA.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Sumic', 'Affiliation': 'OCHIN, 1881 SW Naito Parkway, Portland, OR, 97201, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Cohen', 'Affiliation': 'Oregon Health & Science University, 3405 SW Perimeter Court, Portland, OR, 97239, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'E DeVoe', 'Affiliation': 'Oregon Health & Science University, 3405 SW Perimeter Court, Portland, OR, 97239, USA.'}]",BMC health services research,['10.1186/s12913-020-05317-z'] 447,32492705,Moderate-Intensity Exercise and High-Intensity Interval Training Affect Insulin Sensitivity Similarly in Obese Adults.,"OBJECTIVE We compared the effects of high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) on insulin sensitivity and other important metabolic adaptations in adults with obesity. METHODS Thirty-one inactive adults with obesity (age: 31 ± 6 years; body mass index: 33 ± 3 kg/m2) completed 12 weeks (4 sessions/week) of either HIIT (10 × 1-minute at 90%HRmax, 1-minute active recovery; n = 16) or MICT (45 minutes at 70%HRmax; n = 15). To assess the direct effects of exercise independent of weight/fat loss, participants were required to maintain body mass. RESULTS Training increased peak oxygen uptake by ~10% in both HIIT and MICT (P < 0.0001), and body weight/fat mass were unchanged. Peripheral insulin sensitivity (hyperinsulinemic-euglycemic clamp) was ~20% greater the day after the final exercise session compared to pretraining (P < 0.01), with no difference between HIIT and MICT. When trained participants abstained from exercise for 4 days, insulin sensitivity returned to pretraining levels in both groups. HIIT and MICT also induced similar increases in abundance of many skeletal muscle proteins involved in mitochondrial respiration and lipid and carbohydrate metabolism. Training-induced alterations in muscle lipid profile were also similar between groups. CONCLUSION Despite large differences in training intensity and exercise time, 12 weeks of HIIT and MICT induce similar acute improvements in peripheral insulin sensitivity the day after exercise, and similar longer term metabolic adaptations in skeletal muscle in adults with obesity. These findings support the notion that the insulin-sensitizing effects of both HIIT and MICT are mediated by factors stemming from the most recent exercise session(s) rather than adaptations that accrue with training.",2020,HIIT and MICT also induced similar increases in abundance of many skeletal muscle proteins involved in mitochondrial respiration and lipid and carbohydrate metabolism.,"['adults with obesity', 'obese adults', 'Thirty-one inactive adults with obesity (age: 31±6 years, BMI: 33±3 kg/m2) completed 12 weeks (4 sessions/week) of either HIIT (10x1-minute at 90%HRmax, 1-minute active recovery; n=16) or']","['MICT', 'high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT', 'HIIT and MICT', 'Moderate-intensity exercise and high-intensity interval training']","['muscle lipid profile', 'peak oxygen uptake', 'insulin sensitivity', 'Peripheral insulin sensitivity (hyperinsulinemic-euglycemic clamp', 'body weight/fat mass']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",31.0,0.0721815,HIIT and MICT also induced similar increases in abundance of many skeletal muscle proteins involved in mitochondrial respiration and lipid and carbohydrate metabolism.,"[{'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Ryan', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Schleh', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Cheehoon', 'Initials': 'C', 'LastName': 'Ahn', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Alison C', 'Initials': 'AC', 'LastName': 'Ludzki', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Jenna B', 'Initials': 'JB', 'LastName': 'Gillen', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Pallavi', 'Initials': 'P', 'LastName': 'Varshney', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Douglas W', 'Initials': 'DW', 'LastName': 'Van Pelt', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Pitchford', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Chenevert', 'Affiliation': 'Department of Radiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Gioscia-Ryan', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Suzette M', 'Initials': 'SM', 'LastName': 'Howton', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rode', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Scott L', 'Initials': 'SL', 'LastName': 'Hummel', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Charles F', 'Initials': 'CF', 'LastName': 'Burant', 'Affiliation': 'Division of Metabolism, Endocrinology, and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Little', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Okanagan Campus, Kelowna, British Columbia, Canada.'}, {'ForeName': 'Jeffrey F', 'Initials': 'JF', 'LastName': 'Horowitz', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa345'] 448,32425361,"Efficacy and safety of Lianhuaqingwen capsules, a repurposed Chinese herb, in patients with coronavirus disease 2019: A multicenter, prospective, randomized controlled trial.","Background Coronavirus disease 2019 (Covid-19) has resulted in a global outbreak. Few existing targeted medications are available. Lianhuaqingwen (LH) capsule, a repurposed marketed Chinese herb product, has been proven effective for influenza. Purpose To determine the safety and efficacy of LH capsule in patients with Covid-19. Methods We did a prospective multicenter open-label randomized controlled trial on LH capsule in confirmed cases with Covid-19. Patients were randomized to receive usual treatment alone or in combination with LH capsules (4 capsules, thrice daily) for 14 days. The primary endpoint was the rate of symptom (fever, fatigue, coughing) recovery. Results We included 284 patients (142 each in treatment and control group) in the full-analysis set. The recovery rate was significantly higher in treatment group as compared with control group (91.5% vs . 82.4%, p = 0.022). The median time to symptom recovery was markedly shorter in treatment group (median: 7 vs . 10 days, p < 0.001). Time to recovery of fever (2 vs . 3 days), fatigue (3 vs . 6 days) and coughing (7 vs . 10 days) was also significantly shorter in treatment group (all p < 0.001). The rate of improvement in chest computed tomographic manifestations (83.8% vs . 64.1%, p < 0.001) and clinical cure (78.9% vs . 66.2%, p = 0.017) was also higher in treatment group. However, both groups did not differ in the rate of conversion to severe cases or viral assay findings (both p > 0.05). No serious adverse events were reported. Conclusion In light of the safety and effectiveness profiles, LH capsules could be considered to ameliorate clinical symptoms of Covid-19.",2021,"The rate of improvement in chest computed tomographic manifestations (83.8% vs. 64.1%, P <0.001) and clinical cure (78.9% vs. 66.2%, P= 0.017) was also higher in treatment group.","['patients with Covid-19', '284 patients (142 each in treatment and control group) in the full-analysis set', 'Patients with Coronavirus disease 2019']","['LH capsule', 'Lianhuaqingwen Capsules, a repurposed Chinese Herb', 'usual treatment alone or in combination with LH capsules']","['Efficacy and Safety', 'rate of improvement in chest computed tomographic manifestations', 'coughing', 'Time to recovery of fever', 'fatigue', 'rate of symptom (fever, fatigue, coughing) recovery', 'rate of conversion to severe cases or viral assay findings', 'clinical cure', 'safety and efficacy', 'serious adverse events', 'median time to symptom recovery', 'recovery rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C3852361', 'cui_str': 'lianhuaqingwen'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0019240', 'cui_str': 'Herb'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",284.0,0.213016,"The rate of improvement in chest computed tomographic manifestations (83.8% vs. 64.1%, P <0.001) and clinical cure (78.9% vs. 66.2%, P= 0.017) was also higher in treatment group.","[{'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Hu', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Zhangzhidong Road No. 99, Wuhan 430060, Hubei province, China.'}, {'ForeName': 'Wei-Jie', 'Initials': 'WJ', 'LastName': 'Guan', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong province, 510120 PR China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Bi', 'Affiliation': 'Department of Gynaecology and Obstetrics, Wuhan Red Cross Hospital, 392 Hongkong Road, Wuhan 430015, Hubei province, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Nanchang University, Nanchang 330006, Jiangxi Province, China.'}, {'ForeName': 'Lanjuan', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'The First Affiliated Hospital of College of Medicine, Zhejiang province, China.'}, {'ForeName': 'Boli', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'The First Teaching Hospital of Tianjin University of traditional Chinese medicine.'}, {'ForeName': 'Qingquan', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Beijing Hospital of traditional Chinese medicine, Beijing, China.'}, {'ForeName': 'Yuanlin', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Zhongshan Hospital Affiliated Fudan University, Shanghai, China.'}, {'ForeName': 'Xingwang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Beijing Ditan Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhongping', 'Initials': 'Z', 'LastName': 'Duan', 'Affiliation': 'Youan Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Qingshan', 'Initials': 'Q', 'LastName': 'Zheng', 'Affiliation': 'Shanghai University of traditional Chinese medicine, Shanghai, China.'}, {'ForeName': 'Zifeng', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong province, 510120 PR China.'}, {'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong province, 510120 PR China.'}, {'ForeName': 'Mingfeng', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': ""Fuyang Second People's Hospital, Fuyang, China.""}, {'ForeName': 'Lianguo', 'Initials': 'L', 'LastName': 'Ruan', 'Affiliation': 'Wuhan Jinyintan Hospital, Wuhan, Hubei province, China.'}, {'ForeName': 'Chaomin', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Zhongshan Hospital Affiliated Fudan University, Shanghai, China.'}, {'ForeName': 'Yunting', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Zhangzhidong Road No. 99, Wuhan 430060, Hubei province, China.'}, {'ForeName': 'Zhen-Hua', 'Initials': 'ZH', 'LastName': 'Jia', 'Affiliation': 'Hebei Yiling Hospital, National Key Laboratory of Collateral Disease Research and Innovative Chinese Medicine, Shijiazhuang, Hebei province 050035 PR China.'}, {'ForeName': 'Nan-Shan', 'Initials': 'NS', 'LastName': 'Zhong', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong province, 510120 PR China.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2020.153242'] 449,27179104,Reduced CLEC9A expression in synovial tissue of psoriatic arthritis patients after adalimumab therapy.,"OBJECTIVES We aimed to investigate the early changes in expression of C-type lectin domain family 9, member A (CLEC9A), a C-type lectin that is specifically expressed by the CD141(+) dendritic cell subset that is involved in cross-presentation to CD8(+) T cells, by evaluating gene and/or protein expression in three different compartments [skin, synovial tissue (ST) and serum] after short-term adalimumab treatment in PsA patients compared with placebo. METHODS Patients with active PsA and psoriasis were randomized to receive adalimumab or placebo for 4 weeks. Synovial and skin biopsies were obtained before and after 4 weeks of treatment and serum samples 4 weeks, 12 weeks and 1 year after treatment. Skin and serum from healthy donors were used as control. CLEC9A expression was assessed by immunohistochemistry, double immunofluorescence using terminal deoxynucleotidyl transferase 2'-deoxyuridine 5'-triphosphate nick-end labelling (TUNEL), quantitative PCR and ELISA. RESULTS CLEC9A expression was significantly higher in psoriatic skin compared with healthy donor. In psoriatic skin and PsA ST, CLEC9A(+) cells were in close proximity to TUNEL(+) cells. SF CLEC9A levels were significantly lower compared with paired PsA serum. Adalimumab treatment did not affect CLEC9A serum level and skin expression. However, ST CLEC9A protein expression was significantly decreased after adalimumab treatment compared with the placebo group while CLEC9A gene expression remained unchanged. There was a positive correlation between T cell numbers and ST CLEC9A protein expression. CD141(+) cell numbers and chemokine (C motif) receptor 1 expression were not affected with adalimumab treatment. CONCLUSION Altogether, the present study suggests that the downregulation of synovial CLEC9A might be associated with a novel mechanism by which anti-TNF therapy might reduce CD8-mediated inflammation in PsA patients.",2016,"CD141(+) cell numbers and chemokine (C motif) receptor 1 expression were not affected with adalimumab treatment. ","['Patients with active PsA and psoriasis', 'psoriatic arthritis patients after adalimumab therapy']","['adalimumab or placebo', 'placebo', 'Adalimumab']","[""terminal deoxynucleotidyl transferase 2'-deoxyuridine 5'-triphosphate nick-end labelling (TUNEL), quantitative PCR and ELISA"", 'CLEC9A expression', 'CD141(+) cell numbers and chemokine (C motif) receptor 1 expression', 'CLEC9A serum level and skin expression', 'Synovial and skin biopsies', 'ST CLEC9A protein expression', 'CLEC9A gene expression', 'SF CLEC9A levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}, {'cui': 'C4302634', 'cui_str': 'Adalimumab therapy'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0687124', 'cui_str': 'Terminal deoxynucleotidyl transferase stain'}, {'cui': 'C0057470', 'cui_str': 'deoxyuridine triphosphate'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0007584', 'cui_str': 'Cell Number'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0150866', 'cui_str': 'Biopsy of skin'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}]",,0.0283489,"CD141(+) cell numbers and chemokine (C motif) receptor 1 expression were not affected with adalimumab treatment. ","[{'ForeName': 'Maria I', 'Initials': 'MI', 'LastName': 'Ramos', 'Affiliation': 'Clinical Immunology and Rheumatology Department Experimental Immunology Department.'}, {'ForeName': 'Marcel B M', 'Initials': 'MB', 'LastName': 'Teunissen', 'Affiliation': 'Dermatology Department, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Boy', 'Initials': 'B', 'LastName': 'Helder', 'Affiliation': 'Clinical Immunology and Rheumatology Department Experimental Immunology Department.'}, {'ForeName': 'Saida', 'Initials': 'S', 'LastName': 'Aarrass', 'Affiliation': 'Clinical Immunology and Rheumatology Department Experimental Immunology Department.'}, {'ForeName': 'Maria J H', 'Initials': 'MJ', 'LastName': 'de Hair', 'Affiliation': 'Clinical Immunology and Rheumatology Department.'}, {'ForeName': 'Arno W', 'Initials': 'AW', 'LastName': 'van Kuijk', 'Affiliation': 'Clinical Immunology and Rheumatology Department.'}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Gerlag', 'Affiliation': 'Clinical Immunology and Rheumatology Department.'}, {'ForeName': 'Paul P', 'Initials': 'PP', 'LastName': 'Tak', 'Affiliation': 'Clinical Immunology and Rheumatology Department.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Lebre', 'Affiliation': 'Clinical Immunology and Rheumatology Department Experimental Immunology Department c.lebre@amc.uva.nl.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/kew204'] 450,26811126,Drinkers' memory bias for alcohol picture cues in explicit and implicit memory tasks.,"BACKGROUND Alcohol cues can bias attention and elicit emotional reactions, especially in drinkers. Yet, little is known about how alcohol cues affect explicit and implicit memory processes, and how memory for alcohol cues is affected by acute alcohol intoxication. METHODS Young adult participants (N=161) were randomly assigned to alcohol, placebo, or control beverage conditions. Following beverage consumption, they were shown neutral, emotional and alcohol-related pictures cues. Participants then completed free recall and repetition priming tasks to test explicit and implicit memory, respectively, for picture cues. Average blood alcohol concentration for the alcohol group was 74±13mg/dl when memory testing began. Two mixed linear model analyses were conducted to examine the effects of beverage condition, picture cue type, and their interaction on explicit and implicit memory. RESULTS Picture cue type and beverage condition each significantly affected explicit recall of picture cues, whereas only picture cue type significantly influenced repetition priming. Individuals in the alcohol condition recalled significantly fewer pictures than those in other conditions, regardless of cue type. Both free recall and repetition priming were greater for emotional and alcohol-related cues compared to neutral picture cues. No interaction effects were detected. CONCLUSIONS Young adult drinkers showed enhanced explicit and implicit memory processing of alcohol cues compared to emotionally neutral cues. This enhanced processing for alcohol cues was on par with that seen for positive emotional cues. Acute alcohol intoxication did not alter this preferential memory processing for alcohol cues over neutral cues.",2016,Both free recall and repetition priming were greater for emotional and alcohol-related cues compared to neutral picture cues.,"['Young adult drinkers', 'Young adult participants (N=161']","['alcohol, placebo, or control beverage conditions']","['enhanced explicit and implicit memory processing of alcohol cues', 'explicit recall of picture cues', 'Average blood alcohol concentration']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0561768', 'cui_str': 'Implicit memory (observable entity)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C0684262', 'cui_str': 'Blood Alcohol Level'}]",161.0,0.0200569,Both free recall and repetition priming were greater for emotional and alcohol-related cues compared to neutral picture cues.,"[{'ForeName': 'Tam T', 'Initials': 'TT', 'LastName': 'Nguyen-Louie', 'Affiliation': 'Center of Alcohol Studies, 607 Allison Road, Rutgers University, Piscataway, NJ 08854, United States. Electronic address: ttn045@ucsd.edu.'}, {'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Buckman', 'Affiliation': 'Center of Alcohol Studies, 607 Allison Road, Rutgers University, Piscataway, NJ 08854, United States. Electronic address: jbuckman@rutgers.edu.'}, {'ForeName': 'Suchismita', 'Initials': 'S', 'LastName': 'Ray', 'Affiliation': 'Center of Alcohol Studies, 607 Allison Road, Rutgers University, Piscataway, NJ 08854, United States. Electronic address: shmita@rci.rutgers.edu.'}, {'ForeName': 'Marsha E', 'Initials': 'ME', 'LastName': 'Bates', 'Affiliation': 'Center of Alcohol Studies, 607 Allison Road, Rutgers University, Piscataway, NJ 08854, United States. Electronic address: mebates@rutgers.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2015.12.033'] 451,30548375,A qualitative evaluation of the effects of Metacognitive Reflection and Insight Therapy: 'Living more consciously'.,"OBJECTIVES Extensive research showed that one of the major difficulties that people with schizophrenia spectrum disorders are struggling with involves their ability to reflect on their own and others' mental activities, also defined as metacognition. Several new psychotherapies have been developed to assist patients (re)gain metacognitive capacity, including Metacognitive Reflection and Insight Therapy (MERIT). The current study investigated the client's subjective experience of psychotherapy, to determine whether service users found MERIT effective and whether these gains align with quantitative findings, which processes they considered responsible for these benefits, in which ways participants found MERIT similar or different from other interventions, and whether they experienced non-desirable factors and outcomes. DESIGN All participants who had participated in a randomized controlled trial investigating the efficacy of MERIT were offered a structured post-therapy interview by an independent assessor. Fourteen out of 18 (77%) participants, all of whom had completed therapy, responded. RESULTS Most participants (10/14) indicated that they had experienced the therapy as beneficial to their recovery, and in general contributed to their understanding of their own thinking, which maps closely onto the quantitative findings reported elsewhere. They mainly attributed these changes to their own active role in therapy, the intervention letting them vent and self-express, and forming an alliance with the therapist. CONCLUSIONS Participants reports of change map closely onto the quantitative findings from the randomized controlled trial. Findings are discussed in the frameworks of the metacognitive model of psychosis and the integrative intersubjective model of psychotherapy for psychosis emphasizing the role of the clients as active agent of change. PRACTITIONER POINTS The use of a systematic, qualitative interview at the conclusion of therapy may yield important information regarding process and outcome. Analysis of the interview revealed that clients' perceptions regarding change within themselves closely maps onto quantitative findings. MERIT may not be the appropriate intervention for all clients; some may prefer a more solution-oriented approach such as CBTp or Metacognition-Oriented Social Skills training. Self-expressing with a trained clinician may be therapeutic in itself.",2020,"Several new psychotherapies have been developed to assist patients (re)gain metacognitive capacity, including Metacognitive Reflection and Insight Therapy (MERIT).","['Fourteen out of 18 (77%) participants, all of whom had completed therapy, responded', 'All participants who had participated', 'people with schizophrenia spectrum disorders']",['Metacognitive Reflection'],[],"[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",[],[],,0.0559332,"Several new psychotherapies have been developed to assist patients (re)gain metacognitive capacity, including Metacognitive Reflection and Insight Therapy (MERIT).","[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'de Jong', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, The Netherlands.'}, {'ForeName': 'Ilanit', 'Initials': 'I', 'LastName': 'Hasson-Ohayon', 'Affiliation': 'Department of Psychology, Bar-Ilan University, Ramat-Gan, Israel.'}, {'ForeName': 'Rozanne', 'Initials': 'R', 'LastName': 'van Donkersgoed', 'Affiliation': 'Parnassia Dijk en Duin, Zaandam, The Netherlands.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Aleman', 'Affiliation': 'Department of Clinical Psychology and Experimental Psychopathology, Faculty of Behavioral Sciences, University of Groningen, The Netherlands.'}, {'ForeName': 'Gerdina Hendrika Maria', 'Initials': 'GHM', 'LastName': 'Pijnenborg', 'Affiliation': 'Department of Clinical Psychology and Experimental Psychopathology, Faculty of Behavioral Sciences, University of Groningen, The Netherlands.'}]",Psychology and psychotherapy,['10.1111/papt.12212'] 452,26614647,Immediate and Complex Cardiovascular Adaptation to an Acute Alcohol Dose.,"BACKGROUND The detrimental effects of chronic heavy alcohol use on the cardiovascular system are well established and broadly appreciated. Integrated cardiovascular response to an acute dose of alcohol has been less studied. This study examined the early effects of an acute dose of alcohol on the cardiovascular system, with particular emphasis on system variability and sensitivity. The goal was to begin to understand how acute alcohol disrupts dynamic cardiovascular regulatory processes prior to the development of cardiovascular disease. METHODS Healthy participants (N = 72, age 21 to 29) were randomly assigned to an alcohol, placebo, or no-alcohol control beverage condition. Beat-to-beat heart rate (HR) and blood pressure (BP) were assessed during a low-demand cognitive task prior to and following beverage consumption. Between-group differences in neurocardiac response to an alcohol challenge (blood alcohol concentration ~ 0.06 mg/dl) were tested. RESULTS The alcohol beverage group showed higher average HR, lower average stroke volume, lower HR variability and BP variability, and increased vascular tone baroreflex sensitivity after alcohol consumption. No changes were observed in the placebo group, but the control group showed slightly elevated average HR and BP after beverage consumption, possibly due to juice content. At the level of the individual, an active alcohol dose appeared to disrupt the typically tight coupling between cardiovascular processes. CONCLUSIONS A dose of alcohol quickly invoked multiple cardiovascular responses, possibly as an adaptive reaction to the acute pharmacological challenge. Future studies should assess how exposure to alcohol acutely disrupts or dissociates typically integrated neurocardiac functions.",2015,"No changes were observed in the placebo group, but the control group showed slightly elevated average HR and BP after beverage consumption, possibly due to juice content.","['Healthy participants (N\xa0=\xa072, age 21 to 29']","['alcohol', 'placebo', 'alcohol, placebo, or no-alcohol control beverage condition']","['average HR, lower average stroke volume, lower HR variability and BP variability, and increased vascular tone baroreflex sensitivity', 'average HR and BP', 'Beat-to-beat heart rate (HR) and blood pressure (BP', 'neurocardiac response']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0038455', 'cui_str': 'Stroke Volume'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0206162', 'cui_str': 'Reflex, Baroreceptor'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",,0.0345724,"No changes were observed in the placebo group, but the control group showed slightly elevated average HR and BP after beverage consumption, possibly due to juice content.","[{'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Buckman', 'Affiliation': 'Center of Alcohol Studies, Rutgers, The State University of New Jersey, Piscataway, New Jersey.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Eddie', 'Affiliation': 'Center of Alcohol Studies, Rutgers, The State University of New Jersey, Piscataway, New Jersey.'}, {'ForeName': 'Evgeny G', 'Initials': 'EG', 'LastName': 'Vaschillo', 'Affiliation': 'Center of Alcohol Studies, Rutgers, The State University of New Jersey, Piscataway, New Jersey.'}, {'ForeName': 'Bronya', 'Initials': 'B', 'LastName': 'Vaschillo', 'Affiliation': 'Center of Alcohol Studies, Rutgers, The State University of New Jersey, Piscataway, New Jersey.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Garcia', 'Affiliation': 'Center of Alcohol Studies, Rutgers, The State University of New Jersey, Piscataway, New Jersey.'}, {'ForeName': 'Marsha E', 'Initials': 'ME', 'LastName': 'Bates', 'Affiliation': 'Center of Alcohol Studies, Rutgers, The State University of New Jersey, Piscataway, New Jersey.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.12912'] 453,26461929,Predictive Value of Initial Cervical Length for Subsequent Cervical Length Shortening in Women with a Prior Preterm Birth.,"OBJECTIVE The objective of this study was to estimate the predictive value of the initial cervical length (CL) for later CL shortening in women at high risk for recurrent spontaneous preterm birth (SPTB). Materials and METHODS We conducted a secondary analysis of a multicenter randomized trial of high-risk women with CL screening scheduled at least every 2 weeks from 16(0/7) to 22(6/7) weeks. Primary outcome was CL < 25 mm or SPTB before follow-up CL; the risk of this outcome was analyzed by initial CL at 16(0/7) to 21(6/7) weeks using multivariable logistic regression and receiver operator curves. RESULTS A total of 786 women were identified in the parent trial; 197 (25.0%) developed CL shortening < 23 weeks, 3 (0.4%) delivered within 2 weeks of initial CL measurement (< 24 weeks), and 586 (74.6%) maintained CL ≥ 25 mm. The covariate-adjusted receiver operator characteristics curve had moderate predictive value (area under the curve = 0.748) but did not reveal a clinically useful CL cutoff. Evaluation of selected CL cutoffs demonstrated that an initial CL ≥39 mm had the greatest negative predictive value (85.1%). No CL cutoff existed above which there was no CL shortening, although at ≥ 39 mm only two patients (1.1%) shortened within 2 weeks as compared with 32 (7.1%) patients whose initial CL was < 39 mm (p < 0.001). CONCLUSION In high-risk patients whose initial CL is ≥ 39 mm, CL shortening or delivery is uncommon in the following 2 weeks. Patients with initial CL above this threshold may require less frequent surveillance.",2016,The covariate-adjusted receiver operator characteristics curve had moderate predictive value (area under the curve = 0.748) but did not reveal a clinically useful CL cutoff.,"['high-risk women with CL screening scheduled at least every 2 weeks from 16(0/7) to 22(6/7) weeks', 'women at high risk for recurrent spontaneous preterm birth (SPTB', 'A total of 786 women were identified in the parent trial; 197 (25.0%) developed', 'Women with a Prior Preterm Birth']",['initial cervical length (CL'],"['CL shortening', 'CL\u2009<\u200925\u2009mm or SPTB']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}]","[{'cui': 'C1282927', 'cui_str': 'Shortened (qualifier value)'}]",786.0,0.316354,The covariate-adjusted receiver operator characteristics curve had moderate predictive value (area under the curve = 0.748) but did not reveal a clinically useful CL cutoff.,"[{'ForeName': 'Akila', 'Initials': 'A', 'LastName': 'Subramaniam', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Lorie M', 'Initials': 'LM', 'LastName': 'Harper', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Jeff M', 'Initials': 'JM', 'LastName': 'Szychowski', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Owen', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama.'}]",American journal of perinatology,['10.1055/s-0035-1564425'] 454,31057139,"Personally salient, emotionally negative task contexts provoke goal neglect in depression.","BACKGROUND Goal neglect refers to a dissociation between intended and actual action. Although commonly associated with frontal brain damage, this phenomenon is also characteristic of clinical depression. To date, tests of goal neglect typically require individuals to switch between subtasks populated with neutral stimuli. This study examined the impact of affective and personally salient stimulus contexts on goal neglect in clinical depression. METHODS Participants were randomly allocated to either positively or negatively-valenced versions of the Affective Six Elements Test (A-SET). We hypothesised that depressed individuals (n = 30) would exhibit an overall impairment in A-SET performance by neglecting entire subtasks and allocating suboptimal time to each task, relative to never-depressed peers (n = 30), with effects being strongest for the negatively-valenced version. RESULTS Findings showed that depressed individuals exhibited specific deficits, relative to controls on these measures in the negative A-SET only, with a magnitude comparable to that found in brain injured patients. CONCLUSIONS Individuals with depression are impaired in their ability to monitor performance and implement strategies that are optimal for the purpose of pursuing an overarching goal when the task context is negatively-valenced. Potential mechanisms are discussed.",2020,"RESULTS Findings showed that depressed individuals exhibited specific deficits, relative to controls on these measures in the negative A-SET only, with a magnitude comparable to that found in brain injured patients. ",['Participants'],[],['specific deficits'],[],[],"[{'cui': 'C0205369', 'cui_str': 'Specified'}]",30.0,0.0246317,"RESULTS Findings showed that depressed individuals exhibited specific deficits, relative to controls on these measures in the negative A-SET only, with a magnitude comparable to that found in brain injured patients. ","[{'ForeName': 'Aliza', 'Initials': 'A', 'LastName': 'Werner-Seidler', 'Affiliation': 'Medical Research Council Cognition and Brain Sciences Unit, University of Cambridge, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Dahm', 'Affiliation': 'Medical Research Council Cognition and Brain Sciences Unit, University of Cambridge, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Ann-Marie', 'Initials': 'AM', 'LastName': 'Golden', 'Affiliation': 'Medical Research Council Cognition and Brain Sciences Unit, University of Cambridge, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Manly', 'Affiliation': 'Medical Research Council Cognition and Brain Sciences Unit, University of Cambridge, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Dalgleish', 'Affiliation': 'Medical Research Council Cognition and Brain Sciences Unit, University of Cambridge, Cambridge, Cambridgeshire, UK.'}]",Psychological medicine,['10.1017/S0033291719000886'] 455,32417345,Randomized controlled trial to identify the optimal radiotherapy scheme for palliative treatment of incurable head and neck squamous cell carcinoma.,"BACKGROUND No randomized controlled trials (RCT) have yet identified the optimal palliative radiotherapy scheme in patients with incurable head and neck squamous cell carcinoma (HNSCC). We conducted RCT to compare two radiation schemes in terms of efficacy, toxicity and quality-of-life (QoL). MATERIALS AND METHODS Patients with locally-advanced HNSCC who were ineligible for radical treatment and those with limited metastatic disease were randomly assigned in 1:1 ratio to arm 1 (36 Gy in 6 fractions, twice a week) or arm 2 (50 Gy in 16 fractions, four times a week). RESULTS The trial was discontinued early because of slow accrual (34 patients enrolled). Objective response rates were 38.9% and 57.1% for arm 1 and 2 respectively (p = 0.476). The median time to loco-regional progression was not reached. The loco-regional control rates at 1 year was 57.4% and 69.3% in arm 1 and 2 (p = 0.450, HR = 0.56, 95%CI 0.12-2.58). One-year overall survival was 33.3% and 57.1%, with medians of 35.4 and 59.5 weeks, respectively (p = 0.215, HR = 0.55, 95%CI 0.21-1.43). Acute grade ≥3 toxicity was lower in arm 1 (16.7% versus 57.1%, p = 0.027), with the largest difference in grade 3 mucositis (5.6% versus 42.9%, p = 0.027). However, no significant deterioration in any of the patient-reported QoL-scales was found. CONCLUSION No solid conclusion could be made on this incomplete study which is closed early. Long-course radiotherapy did not show significantly better oncologic outcomes, but was associated with more acute grade 3 mucositis. No meaningful differences in QoL-scores were found. Therefore, the shorter schedule might be carefully advocated. However, this recommendation should be interpreted with great caution because of the inadequate statistical power.",2020,Objective response rates were 38.9% and 57.1% for arm 1 and 2 respectively (p=0.476).,"['patients with incurable head and neck squamous cell carcinoma (HNSCC', 'incurable head and neck squamous cell carcinoma', 'Patients with locally-advanced HNSCC who were ineligible for radical treatment and those with limited metastatic disease']",[],"['grade 3 mucositis', 'QoL-scores', 'efficacy, toxicity and quality-of-life (QoL', 'Acute grade ≥3 toxicity', 'median time to loco-regional progression', 'QoL-scales', 'overall survival', 'loco-regional control rates', 'acute grade 3 mucositis', 'oncologic outcomes', 'Objective response rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",[],"[{'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205478', 'cui_str': 'Oncologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",34.0,0.193028,Objective response rates were 38.9% and 57.1% for arm 1 and 2 respectively (p=0.476).,"[{'ForeName': 'Abrahim', 'Initials': 'A', 'LastName': 'Al-Mamgani', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands. Electronic address: a.almamgani@nki.nl.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Kessels', 'Affiliation': 'Department of Biometrics, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Cornelia G', 'Initials': 'CG', 'LastName': 'Verhoef', 'Affiliation': 'Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Navran', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Hamming-Vrieze', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Johannes H A M', 'Initials': 'JHAM', 'LastName': 'Kaanders', 'Affiliation': 'Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Roel J H M', 'Initials': 'RJHM', 'LastName': 'Steenbakkers', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Groningen, University of Groningen, the Netherlands.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tans', 'Affiliation': 'Department of Radiation Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Hoebers', 'Affiliation': 'Department of Radiation Oncology (MAASTRO Clinic), GROW - School for Oncology and Developmental Biology, Maastricht University Medical Center, The Netherlands.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Ong', 'Affiliation': 'Department of Radiation Oncology, Medisch Spectrum Twente, The Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'van Werkhoven', 'Affiliation': 'Department of Biometrics, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Johannes A', 'Initials': 'JA', 'LastName': 'Langendijk', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Groningen, University of Groningen, the Netherlands.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.05.020'] 456,32418078,"Postoperative Adjuvant Transarterial Infusion Chemotherapy with FOLFOX Could Improve Outcomes of Hepatocellular Carcinoma Patients with Microvascular Invasion: A Preliminary Report of a Phase III, Randomized Controlled Clinical Trial.","BACKGROUND Microvascular invasion (MVI) is a risk factor for tumor recurrence after hepatectomy in hepatocellular carcinoma (HCC) patients. OBJECTIVE This study aimed to investigate the efficacy and safety of postoperative adjuvant transarterial infusion chemotherapy (TAI) with the FOLFOX regimen for HCC patients with MVI. METHODS In this prospective, phase III, randomized, open-label, controlled clinical trial, HCC patients with histologically confirmed MVI were randomly assigned (1:1) after hepatectomy to receive either one to two cycles of adjuvant TAI (AT group) or follow-up without any adjuvant treatment (FU group). The primary endpoint was disease-free survival (DFS), while secondary endpoints were overall survival (OS) and safety. RESULTS Between June 2016 and April 2019, 127 patients were randomly assigned to the AT group (n = 63) or FU group (n = 64). Clinicopathological characteristics of the two groups were well-balanced. The 6-, 12-, and 18-month OS rates for the AT group were 100.0%, 97.7%, and 97.7%, respectively, and 94.5%, 89.6%, and 78.5% for the FU group, respectively. The 6-, 12-, and 18-month DFS rates for the AT and FU groups were 84.7%, 61.8%, and 58.7%, and 62.9%, 48.1%, and 38.6%, respectively. OS and DFS were significantly better in the AT group than in the FU group (p = 0.037 and 0.023, respectively). No patients in the AT group experienced grade 3 or more severe adverse events. CONCLUSIONS Adjuvant TAI after hepatectomy may bring survival benefits to HCC patients with MVI. TRIAL REGISTRATION Trial number: NCT03192618.",2020,"OS and DFS were significantly better in the AT group than in the FU group (p = 0.037 and 0.023, respectively).","['Between June 2016 and April 2019', 'Hepatocellular Carcinoma Patients with Microvascular Invasion', 'hepatocellular carcinoma (HCC) patients', 'HCC patients with histologically confirmed MVI', 'HCC patients with MVI', '127 patients']","['adjuvant TAI (AT group) or follow-up without any adjuvant treatment (FU group', 'FU', 'postoperative adjuvant transarterial infusion chemotherapy (TAI', 'FOLFOX']","['OS and DFS', 'OS rates', 'severe adverse events', 'survival benefits', 'efficacy and safety', 'DFS rates', 'overall survival (OS) and safety', 'disease-free survival (DFS']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0522522', 'cui_str': 'Transarterial approach'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",127.0,0.100369,"OS and DFS were significantly better in the AT group than in the FU group (p = 0.037 and 0.023, respectively).","[{'ForeName': 'Shaohua', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Mei', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Qiaoxuan', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Zhixing', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': ""State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Lianghe', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Yihong', 'Initials': 'Y', 'LastName': 'Ling', 'Affiliation': ""State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Minshan', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Lie', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': ""State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Wenping', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Yuhua', 'Initials': 'Y', 'LastName': 'Wen', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China. weiwei@sysucc.org.cn.""}, {'ForeName': 'Rongping', 'Initials': 'R', 'LastName': 'Guo', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China. guorp@sysucc.org.cn.""}]",Annals of surgical oncology,['10.1245/s10434-020-08601-8'] 457,32420649,Comparison of vortioxetine and sertraline for treatment of major depressive disorder in elderly patients: A double-blind randomized trial.,"WHAT IS KNOWN AND OBJECTIVE Major depressive disorder (MDD) is a complex disease and one of the leading contributors to disease burden throughout the world. In the current study, we explored the efficacy and tolerability of vortioxetine versus sertraline on symptoms of depression in elderly patients with MDD. METHODS Sixty patients diagnosed with MDD (based on DSM-5) and Hamilton Depression Rating Scale (HAM-D) score ≥ 19 were entered into a randomized double-blind study and were randomized to receive either vortioxetine (15 mg daily) or sertraline (75 mg daily) for six weeks. Patients were assessed using the HAM-D scale at baseline and weeks 3 and 6. Changes in HAM-D score, response rates, remission rate and time to response or remission were also compared between the two study groups. RESULTS AND DISCUSSION Fifty patients completed the trial after six weeks. General linear model repeated measures demonstrated no difference in trend of the two treatment groups (P = .897). There was no significantly different improvement in the HDRS scores from baseline to weeks 3 and 6, as well. Differences in response rate, remission rate, time to response and time to remission periods were not statistically significant. Finally, there was not any significantly difference between the two study groups in the frequency of adverse events. WHAT IS NEW AND CONCLUSION This study showed no significant differences in the efficacy and safety of vortioxetine in comparison with sertraline in order for it to be used safely for treatment of major depressive disorder in elderly patients.",2020,This study showed no significant differences in the efficacy and safety of vortioxetine in comparison with sertraline in order for it to be used safely for treatment of major depressive disorder in elderly patients.,"['elderly patients with MDD', 'Sixty patients diagnosed with MDD (based on DSM-5) and Hamilton Depression Rating Scale (HAM-D) score\xa0≥\xa019', 'major depressive disorder in elderly patients', 'Fifty patients completed the trial after six weeks']","['vortioxetine', 'vortioxetine and sertraline', 'sertraline']","['HAM-D scale', 'HDRS scores', 'frequency of adverse events', 'efficacy and tolerability', 'efficacy and safety', 'HAM-D score, response rates, remission rate and time to response or remission', 'response rate, remission rate, time to response and time to remission periods']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C3661282', 'cui_str': 'vortioxetine'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1840333', 'cui_str': 'Hypoparathyroidism, deafness, renal disease syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",60.0,0.192844,This study showed no significant differences in the efficacy and safety of vortioxetine in comparison with sertraline in order for it to be used safely for treatment of major depressive disorder in elderly patients.,"[{'ForeName': 'Firouzeh', 'Initials': 'F', 'LastName': 'Borhannejad', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Shariati', 'Affiliation': 'Mental Health Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Naderi', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Shalbafan', 'Affiliation': 'Mental Health Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amirhosein', 'Initials': 'A', 'LastName': 'Mortezaei', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Erfan', 'Initials': 'E', 'LastName': 'Sahebolzamani', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Atefe', 'Initials': 'A', 'LastName': 'Saeb', 'Affiliation': 'Mental Health Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyyed', 'Initials': 'S', 'LastName': 'Hosein Mortazavi', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Kamalzadeh', 'Affiliation': 'Mental Health Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Aqamolaei', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Ali Noorbala', 'Affiliation': 'Psychosomatic Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Namazi-Shabestari', 'Affiliation': 'Department of Geriatric, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Akhondzadeh', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}]",Journal of clinical pharmacy and therapeutics,['10.1111/jcpt.13177'] 458,25421470,Population pharmacokinetics of micafungin and its metabolites M1 and M5 in children and adolescents.,"The aim of this analysis was to identify therapeutic micafungin regimens for children that produce the same micafungin exposures known to be effective for the prevention and treatment of Candida infections in adults. Pediatric pharmacokinetic data from 229 patients between the ages of 4 months and <17 years were obtained from four phase I and two phase III clinical trials. Population pharmacokinetic models were used to simulate the proportion of children who had a steady-state area under the concentration-time curve at 24 hours (AUC24) of micafungin within the 10th to 90th percentile range observed in a population of adults receiving a dose of micafungin with established efficacy for invasive candidiasis (100 mg/day), i.e., 75 to 139 μg·h/ml. Simulated pediatric dosages of 0.5 to 5 mg/kg of body weight/day were explored. A two-compartment model was used that incorporated body weight as a predefined covariate for allometric scaling of the pharmacokinetic parameters. During construction of the model, aspartate aminotransferase and total bilirubin were also identified as covariates that had a significant effect on micafungin clearance. A dose of 2 mg/kg resulted in the highest proportion of children within the predefined micafungin AUC24 target range for invasive candidiasis. Cutoffs of 40 or 50 kg for weight-based dosing resulted in heavier children being appropriately dosed. Thus, dose regimens of 1, 2, and 3 mg/kg/day micafungin are appropriate for the prevention of invasive candidiasis, the treatment of invasive candidiasis, and the treatment of esophageal candidiasis, respectively, in children aged 4 months to <17 years.",2015,A dose of 2 mg/kg resulted in the highest proportion of children within the predefined micafungin AUC24 target range for invasive candidiasis.,"['children who had a steady-state area under the concentration-time curve at 24 hours (AUC24) of micafungin within the 10th to 90th percentile range observed in a population of adults receiving a dose of micafungin with established efficacy for invasive candidiasis (100 mg/day), i.e., 75 to 139 μg·h/ml', 'children and adolescents', 'children aged 4 months to <17 years', 'adults', '229 patients between the ages of 4 months and <17 years were obtained from four phase']",[],"['aspartate aminotransferase and total bilirubin', 'micafungin clearance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C1120386', 'cui_str': 'micafungin'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]",[],"[{'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0201913', 'cui_str': 'Bilirubin, total measurement (procedure)'}, {'cui': 'C1120386', 'cui_str': 'micafungin'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}]",229.0,0.0417469,A dose of 2 mg/kg resulted in the highest proportion of children within the predefined micafungin AUC24 target range for invasive candidiasis.,"[{'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Hope', 'Affiliation': 'Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, United Kingdom william.hope@liverpool.ac.uk.'}, {'ForeName': 'Atsunori', 'Initials': 'A', 'LastName': 'Kaibara', 'Affiliation': 'Astellas Pharma, Northbrook, Illinois, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Roy', 'Affiliation': 'Astellas Pharma, Northbrook, Illinois, USA.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Arrieta', 'Affiliation': ""Children's Hospital of Orange County, Division of Infectious Disease, Orange, California, USA.""}, {'ForeName': 'Nkechi', 'Initials': 'N', 'LastName': 'Azie', 'Affiliation': 'Astellas Pharma, Northbrook, Illinois, USA.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Kovanda', 'Affiliation': 'Astellas Pharma, Northbrook, Illinois, USA.'}, {'ForeName': 'Daniel K', 'Initials': 'DK', 'LastName': 'Benjamin', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.03736-14'] 459,27168455,Fermented Milk Consumption and Common Infections in Children Attending Day-Care Centers: A Randomized Trial.,"OBJECTIVES This multicenter, double-blind, randomized, placebo-controlled clinical trial investigated the effect of a fermented milk product containing the Lactobacillus casei National Collection of Microorganisms and Cell Cultures (CNCM) I-1518 strain on respiratory and gastrointestinal common infectious diseases (CIDs) in children attending day-care centers in Russia. METHODS Children ages 3 to 6 years received 100 g of a fermented milk product (n = 300) or a control product (n = 299) twice daily for 3 months, followed by a 1-month observation period. The primary outcome was the incidence of CIDs during the product consumption period. RESULTS There was no significant difference in the incidence of CIDs between the groups (N = 98 with fermented milk product vs N = 93 with control product). The overall number of CIDs (and no severe cases at all) in both study groups and in all 12 centers, however, was unexpectedly low resulting in underpowering of the study. No differences were found between the groups in the duration or severity of disease, duration of sick leave from day-care centers, parental missed working days, or in quality-of-life dimensions on the PedsQL questionnaire (P > 0.05).There was, however, a significantly lower incidence of the most frequently observed CID, rhinopharyngitis, in children consuming the fermented milk product compared with those consuming the control product (N = 81 vs N = 100, relative risk 0.82, 95% confidence interval 0.69-0.96, P = 0.017) when considering the entire study period. CONCLUSIONS Although no other significant differences were shown between the fermented milk and control product groups in this study, lower incidence of rhinopharyngitis may indicate a beneficial effect of this fermented milk product.",2016,There was no significant difference in the incidence of CIDs between the groups (N = 98 with fermented milk product vs N = 93 with control product).,"['Attending Day-Care Centers', 'children attending day-care centers in Russia', 'Children ages 3 to 6 years received 100 g of a', 'Children']","['fermented milk product (n\u200a=\u200a300) or a control product', 'fermented milk product containing the Lactobacillus casei National Collection of Microorganisms and Cell Cultures (CNCM) I-1518 strain', 'placebo']","['duration or severity of disease, duration of sick leave from day-care centers, parental missed working days, or in quality-of-life dimensions on the PedsQL questionnaire', 'incidence of CIDs', 'overall number of CIDs', 'incidence of CIDs during the product consumption period']","[{'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0175952', 'cui_str': 'Day care center (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035970', 'cui_str': 'Russian Federation (Europe)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C1257811', 'cui_str': 'Cultured Milk Products'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0022940', 'cui_str': 'Lactobacillus casei'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0445623', 'cui_str': 'Microorganism (organism)'}, {'cui': 'C0007585', 'cui_str': 'Cell Culture Techniques'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0175952', 'cui_str': 'Day care center (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.0759874,There was no significant difference in the incidence of CIDs between the groups (N = 98 with fermented milk product vs N = 93 with control product).,"[{'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Prodeus', 'Affiliation': '*Children\'s Clinical Hospital No. 9 named after G.N. Speransky of Moscow Healthcare Department, Moscow, Russia †Danone Nutricia Research, Centre de Recherche Daniel Carasso, Palaiseau, France ‡University Medicine, Johannes-Gutenberg-University, Mainz, Germany §Federal Budget Institution of Science ""Central Research Institute of Epidemiology"" of The Federal Service on Customers\' Rights Protection and Human Well-being Surveillance ||Federal Government Budget Institution ""Federal Scientific Clinical Center of Pediatric Hematology, Oncology and Immunology named after Dmitry Rogachev"" of the Ministry of Health of Russian Federation, Moscow, Russia.'}, {'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'Niborski', 'Affiliation': ''}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Schrezenmeir', 'Affiliation': ''}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Gorelov', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Shcherbina', 'Affiliation': ''}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Rumyantsev', 'Affiliation': ''}]",Journal of pediatric gastroenterology and nutrition,[] 460,31554765,Effect of Statin on Stroke Recurrence Prevention at Different Infarction Locations: A Post Hoc Analysis of The J-STARS Study.,"AIM Posterior circulation stroke (PCS) has different clinical features and prognosis compared with anterior circulation stroke (ACS), and whether the effect of statin therapy on stroke prevention differs according to infarction location remains unclear. This post hoc analysis of the J-STARS study aimed to compare the usefulness of statin at different infarction locations (i.e., ACS and PCS). METHODS In the J-STARS study, 1578 patients were randomly assigned to the pravastatin or control group. The subjects were divided into two subgroups (ACS and PCS groups) based on the arteries responsible for the infarction. Cox proportional hazards models were used to investigate whether the all stroke recurrence rate was different between the ACS and PCS groups. RESULTS The PCS group (n=499) had a significantly higher prevalence of diabetes than the ACS group (n=1022) (30.7% vs. 19.8%, P＜0.001). During the follow-up (4.9±1.4 years), the incidence of all stroke was significantly lower in the pravastatin group than in the control group among patients with PCS (adjusted hazard ratio [HR] 0.46, 95% confidence interval [CI] 0.25-0.83, P=0.009); however, the stroke recurrence rates were not significantly different between both groups among patients with ACS (adjusted HR 1.32, 95% CI 0.93-1.88,P=0.123). A significant interaction between the ACS and PCS groups in terms of pravastatin effects was noted (P=0.003 for interaction). CONCLUSIONS Pravastatin significantly reduced the recurrence rate of all stroke among patients with PCS. Thus, the effect of statin on the recurrence of stroke may differ according to infarction location.",2020,"During the follow-up (4.9±1.4 years), the incidence of all stroke was significantly lower in the pravastatin group than in the control group among patients with PCS (adjusted hazard ratio [HR] 0.46, 95% confidence interval [CI] 0.25-0.83, P=0.009); however, the stroke recurrence rates were not significantly different between both groups among patients with ACS (adjusted HR 1.32, 95% CI 0.93-1.88,P=0.123).","['at Different Infarction Locations', '1578 patients', 'patients with PCS']","['Statin', 'pravastatin', 'Pravastatin', 'statin therapy', 'PCS', 'Posterior circulation stroke (PCS', 'ACS', 'statin']","['Stroke Recurrence Prevention', 'stroke recurrence rate', 'incidence of all stroke', 'prevalence of diabetes', 'stroke recurrence rates', 'recurrence rate', 'pravastatin effects']","[{'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0085542', 'cui_str': 'Pravastatin'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0085542', 'cui_str': 'Pravastatin'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",1578.0,0.0441505,"During the follow-up (4.9±1.4 years), the incidence of all stroke was significantly lower in the pravastatin group than in the control group among patients with PCS (adjusted hazard ratio [HR] 0.46, 95% confidence interval [CI] 0.25-0.83, P=0.009); however, the stroke recurrence rates were not significantly different between both groups among patients with ACS (adjusted HR 1.32, 95% CI 0.93-1.88,P=0.123).","[{'ForeName': 'Tomohisa', 'Initials': 'T', 'LastName': 'Nezu', 'Affiliation': 'Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences.'}, {'ForeName': 'Naohisa', 'Initials': 'N', 'LastName': 'Hosomi', 'Affiliation': 'Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Kitagawa', 'Affiliation': ""Department of Neurology, Tokyo Women's Medical University School of Medicine.""}, {'ForeName': 'Yoji', 'Initials': 'Y', 'LastName': 'Nagai', 'Affiliation': 'Center for Clinical Research, Kobe University Hospital.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Nakagawa', 'Affiliation': 'Division of Medical Statistics, Translational Research Informatics Center, Foundation for Biomedical Research and Innovation.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Aoki', 'Affiliation': 'Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Kagimura', 'Affiliation': 'Division of Medical Statistics, Translational Research Informatics Center, Foundation for Biomedical Research and Innovation.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Maruyama', 'Affiliation': 'Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Origasa', 'Affiliation': 'Division of Biostatistics and Clinical Epidemiology, University of Toyama Graduate School of Medicine and Pharmaceutical Sciences.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Minematsu', 'Affiliation': 'National Cerebral and Cardiovascular Center.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Uchiyama', 'Affiliation': 'Clinical Research Center for Medicine, International University of Health and Welfare, Center for Brain and Cerebral Vessels, Sanno Hospital and Sanno Medical Center.'}, {'ForeName': 'Masayasu', 'Initials': 'M', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of atherosclerosis and thrombosis,['10.5551/jat.51391'] 461,25633713,Arming the Melanoma Sentinel Lymph Node through Local Administration of CpG-B and GM-CSF: Recruitment and Activation of BDCA3/CD141(+) Dendritic Cells and Enhanced Cross-Presentation.,"Melanoma-induced suppression of dendritic cells (DC) in the sentinel lymph node (SLN) interferes with the generation of protective antitumor immunity. In an effort to strengthen immune defense against metastatic spread, we performed a three-arm phase II study comprising 28 patients with stage I-II melanoma randomized to receive intradermal injections around the primary tumor excision site of saline or low-dose CpG-B, alone or combined with GM-CSF, before excision of the SLNs. After pathologic examination, 5 patients were diagnosed with stage III melanoma based on the presence of tumor cells in the SLNs. Combined CpG/GM-CSF administration resulted in enhanced maturation of all identifiable conventional (cDC) and plasmacytoid (pDC) DC subsets and selectively induced increased frequencies of SLN-resident BDCA3/CD141(+) cDC subsets that also expressed the C-type lectin receptor CLEC9A. Correlative in vivo analyses and in vitro studies provided evidence that these subsets were derived from BDCA3(+) cDC precursors in the blood that were recruited to the SLNs in a type I IFN-dependent manner and subsequently matured under the combined influence of CpG and GM-CSF. In line with their reported functional abilities, frequencies of in vivo CpG/GM-CSF-induced BDCA3/CD141(+) DCs correlated with increased ex vivo cross-presenting capacity of SLN suspensions. Combined local CpG/GM-CSF delivery thus supports protective antimelanoma immunity through concerted activation of pDC and cDC subsets and recruitment of BDCA3(+) cDC subsets with T cell-stimulatory and cross-priming abilities.",2015,Combined local CpG/GM-CSF delivery thus supports protective antimelanoma immunity through concerted activation of pDC and cDC subsets and recruitment of BDCA3(+) cDC,['28 patients with stage I-II melanoma randomized to receive'],"['BDCA3', 'Combined CpG/GM-CSF', 'Combined local CpG/GM-CSF', 'intradermal injections around the primary tumor excision site of saline or low-dose CpG-B, alone or combined with GM-CSF, before excision of the SLNs', 'BDCA3/CD141']","['frequencies of SLN-resident BDCA3/CD141(+) cDC', 'Dendritic Cells and Enhanced Cross-Presentation', 'enhanced maturation of all identifiable conventional (cDC) and plasmacytoid (pDC) DC subsets']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}]","[{'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0021489', 'cui_str': 'Intradermal injection (procedure)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1299802', 'cui_str': 'Excision of neoplasm'}, {'cui': 'C2945843', 'cui_str': 'Site of (attribute)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0007670', 'cui_str': 'CDC'}, {'cui': 'C0011306', 'cui_str': 'Dendritic Cells'}, {'cui': 'C1257986', 'cui_str': 'Cross-Presentation'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]",28.0,0.140432,Combined local CpG/GM-CSF delivery thus supports protective antimelanoma immunity through concerted activation of pDC and cDC subsets and recruitment of BDCA3(+) cDC,"[{'ForeName': 'Berbel J R', 'Initials': 'BJ', 'LastName': 'Sluijter', 'Affiliation': 'Department of Surgical Oncology, VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Mari F C M', 'Initials': 'MF', 'LastName': 'van den Hout', 'Affiliation': 'Department of Pathology, VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Bas D', 'Initials': 'BD', 'LastName': 'Koster', 'Affiliation': 'Department of Medical Oncology, VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Paul A M', 'Initials': 'PA', 'LastName': 'van Leeuwen', 'Affiliation': 'Department of Surgical Oncology, VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Famke L', 'Initials': 'FL', 'LastName': 'Schneiders', 'Affiliation': 'Department of Medical Oncology, VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Rieneke', 'Initials': 'R', 'LastName': 'van de Ven', 'Affiliation': 'Department of Medical Oncology, VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Barbara G', 'Initials': 'BG', 'LastName': 'Molenkamp', 'Affiliation': 'Department of Surgical Oncology, VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Vosslamber', 'Affiliation': 'Department of Pathology, VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Cornelis L', 'Initials': 'CL', 'LastName': 'Verweij', 'Affiliation': 'Department of Pathology, VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'M Petrousjka', 'Initials': 'MP', 'LastName': 'van den Tol', 'Affiliation': 'Department of Surgical Oncology, VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Alfons J M', 'Initials': 'AJ', 'LastName': 'van den Eertwegh', 'Affiliation': 'Department of Medical Oncology, VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Rik J', 'Initials': 'RJ', 'LastName': 'Scheper', 'Affiliation': 'Department of Pathology, VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Tanja D', 'Initials': 'TD', 'LastName': 'de Gruijl', 'Affiliation': 'Department of Medical Oncology, VU University Medical Center, Amsterdam, the Netherlands. td.degruijl@vumc.nl.'}]",Cancer immunology research,['10.1158/2326-6066.CIR-14-0165'] 462,32425134,Comparison of dynamic arterial and venous pressure between metal needles and plastic cannulas in incident hemodialysis patients with arteriovenous graft.,"BACKGROUND AND OBJECTS We hypothesized that plastic cannulae with 17-gauge inner needle compared to 16-gauge metal needles can have stable dynamic venous and arterial pressure maintaining prescribed blood flow safely during a hemodialysis treatment. DESIGN, SETTING, PARTICIPANTS, AND MEASUREMENTS A single-center, prospective, randomized, open-label clinical trial was conducted involving 16 incident hemodialysis patients who had arteriovenous graft placed as their first arteriovenous access. Subjects were randomized to metal needle group (n = 8) versus plastic cannula group (n = 8). We measured serial dynamic pre-pump arterial and venous pressure under five different blood pump flow rates (150, 200, 250, 300, and 350 mL/min). RESULTS The mean age of patients was 67.6 ± 8.5 (range: 51-81) years, and six patients (37.5%) were male. Patients with plastic cannula showed less negative arterial pre-pump pressures and lower venous pressures than those with metal needles at all prescribed blood flow rates, and the difference was statistically significant (P < 0.001). CONCLUSION The plastic cannula had more stable arterial and venous pressures at prescribed blood pump flow rates than those pressures of the metal needle in incident patients with arteriovenous graft during hemodialysis.",2021,"Patients with plastic cannula showed less negative arterial pre-pump pressures and lower venous pressures than those with metal needles at all prescribed blood flow rates, and the difference was statistically significant (P < 0.001). ","['16 incident hemodialysis patients who had arteriovenous graft placed as their first arteriovenous access', 'incident hemodialysis patients with arteriovenous graft', 'The mean age of patients was 67.6\u2009±\u20098.5 (range: 51-81)\u2009years, and six patients (37.5%) were male']","['dynamic arterial and venous pressure between metal needles and plastic cannulas', 'metal needle group (n\u2009=\u20098) versus plastic cannula']","['negative arterial pre-pump pressures and lower venous pressures', 'blood flow rates', 'stable arterial and venous pressures']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0729665', 'cui_str': 'Arteriovenous graft'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517742', 'cui_str': '37.5'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0042486', 'cui_str': 'Venous pressure'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0032167', 'cui_str': 'Plastic'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0042486', 'cui_str': 'Venous pressure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",16.0,0.0265089,"Patients with plastic cannula showed less negative arterial pre-pump pressures and lower venous pressures than those with metal needles at all prescribed blood flow rates, and the difference was statistically significant (P < 0.001). ","[{'ForeName': 'Sun Ryoung', 'Initials': 'SR', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Dongtan, Republic of Korea.'}, {'ForeName': 'Pyoungju', 'Initials': 'P', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea.'}, {'ForeName': 'Sohee', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': 'Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea.'}, {'ForeName': 'Cheolsu', 'Initials': 'C', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea.'}, {'ForeName': 'Narae', 'Initials': 'N', 'LastName': 'Joo', 'Affiliation': 'Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea.'}, {'ForeName': 'Jwa Kyung', 'Initials': 'JK', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea.'}, {'ForeName': 'Young Rim', 'Initials': 'YR', 'LastName': 'Song', 'Affiliation': 'Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea.'}, {'ForeName': 'Hyung Jik', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea.'}, {'ForeName': 'Sung Gyun', 'Initials': 'SG', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea.'}, {'ForeName': 'Hyung Seok', 'Initials': 'HS', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea.'}]",The journal of vascular access,['10.1177/1129729820916579'] 463,32416376,Accelerating prostate stereotactic ablative body radiotherapy: Efficacy and toxicity of a randomized phase II study of 11 versus 29 days overall treatment time (PATRIOT).,"BACKGROUND Prostate stereotactic ablative radiotherapy (SABR) regimens differ in time, dose, and fractionation. We report an update of a multicentre, Canadian randomized phase II study to investigate the impact of overall treatment time on quality of life (QOL), efficacy, and toxicity. METHODS Men with intermediate risk prostate cancer were randomized to 40 Gy in 5 fractions delivered every other day (EOD) versus once per week (QW). Primary outcome was proportion of patients experiencing a minimally clinically important change (MCIC) in acute bowel QOL using EPIC. Secondary outcomes were toxicity, biochemical failure (BF), other QOL domains, and the rate of salvage therapy. FINDINGS 152 men from 3 centers were randomized; the median follow-up was 62 months. Results are described for EOD versus QW. Acute bowel and urinary QOL was reported previously. Late changes in QOL were not significantly different between the two arms. There were 1 (1.3%) vs 3 (2.7%) late grade 3 + GI toxicities (p = 0.36) and 5 (6.7%) vs 2 (2.7%) late grade 3 GU toxicities (p = 0.44). Two and 5 patients had BF (5-year failure rate 3.0 vs 7.2%, p = 0.22); 0 and 4 patients received salvage therapy (p = 0.04). 5-Year OS and CSS was 95.8% and 98.6% with no difference between arms (p = 0.49, p = 0.15). 3 patients in the QW arm developed metastases. INTERPRETATION Although we previously reported that weekly prostate SABR had better bowel and urinary QOL compared to EOD, the updated results show no difference in late toxicity, QOL, BF, or PSA kinetics. Patients should be counseled that QW SABR reduces short-term toxicity compared to QW SABR.",2020,Late changes in QOL were not significantly different between the two arms.,"['152 men from 3 centers', 'Men with intermediate risk prostate cancer']","['Accelerating prostate stereotactic ablative body radiotherapy', 'salvage therapy', 'Prostate stereotactic ablative radiotherapy (SABR']","['late toxicity, QOL, BF, or PSA kinetics', 'Late changes in QOL', 'proportion of patients experiencing a minimally clinically important change (MCIC) in acute bowel QOL using EPIC', 'Acute bowel and urinary QOL', 'bowel and urinary QOL', 'metastases', 'BF (5-year failure rate', 'late grade 3 GU toxicities', 'toxicity, biochemical failure (BF), other QOL domains, and the rate of salvage therapy', '5-Year OS and CSS', 'quality of life (QOL), efficacy, and toxicity', 'late grade 3\xa0+\xa0GI toxicities']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C1273342', 'cui_str': 'Epithelial cell count'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0265338', 'cui_str': 'Coffin-Siris syndrome'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",152.0,0.180251,Late changes in QOL were not significantly different between the two arms.,"[{'ForeName': 'Yasir', 'Initials': 'Y', 'LastName': 'Alayed', 'Affiliation': 'Radiation Oncology Unit, Department of Medicine, College of Medicine and College of Medicine Research Center, King Saud University, Saudi Arabia; Oncology Center, King Saud University Medical City, Saudi Arabia; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Harvey', 'Initials': 'H', 'LastName': 'Quon', 'Affiliation': 'Tom Baker Cancer Centre, Calgary, Canada.'}, {'ForeName': 'Aldrich', 'Initials': 'A', 'LastName': 'Ong', 'Affiliation': 'CancerCare Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Cheung', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Chu', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Chung', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Vesprini', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Chowdhury', 'Affiliation': 'CancerCare Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Dilip', 'Initials': 'D', 'LastName': 'Panjwani', 'Affiliation': 'BC Cancer Agency, Abbotsford, Canada.'}, {'ForeName': 'Geordi', 'Initials': 'G', 'LastName': 'Pang', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Korol', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Davidson', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Ananth', 'Initials': 'A', 'LastName': 'Ravi', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Boyd', 'Initials': 'B', 'LastName': 'McCurdy', 'Affiliation': 'CancerCare Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Mamedov', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Deabreu', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Loblaw', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada; Institute of Health Policy Management and Evaluation, University of Toronto, Canada. Electronic address: andrew.loblaw@sunnybrook.ca.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.04.039'] 464,26317968,Physical changes in the home environment to reduce television viewing and sugar-sweetened beverage consumption among 5- to 12-year-old children: a randomized pilot study.,"This study evaluated the feasibility of a home-based intervention to reduce sugar-sweetened beverage intake and television viewing among children. Lower income parents of overweight children aged 5-12 years (n = 40) were randomized to a home environment intervention to reduce television viewing with locking devices and displace availability of sugar-sweetened beverages with home delivery of non-caloric beverages (n = 25), or to a no-intervention control group (n = 15) for 6 months. Data were collected at baseline and 6 months. After 6 months, television viewing hours per day was significantly lower in the intervention group compared with the control group (1.7 [SE = .02] vs. 2.6 [SE = .25] hours/day, respectively, P < .01). Sugar-sweetened beverage intake was marginally significantly lower among intervention group compared to control group children (0.21 [SE = .09] vs. 0.45 [SE = .10], respectively, P < .09). Body mass index (BMI) z-score was not significantly lower among intervention compared to control children. Among a lower income sample of children, a home-based intervention reduced television viewing, but not sugar-sweetened beverage intake or BMI z-score.",2016,"Sugar-sweetened beverage intake was marginally significantly lower among intervention group compared to control group children (0.21 [SE = .09] vs. 0.45 [SE = .10], respectively, P < .09).","['Lower income parents of overweight children aged 5-12 years (n\u2009=\u200940', 'children', '5- to 12-year-old children']","['home environment intervention to reduce television viewing with locking devices and displace availability of sugar-sweetened beverages with home delivery of non-caloric beverages (n\u2009=\u200925), or to a no-intervention control group', 'home-based intervention to reduce sugar-sweetened beverage intake and television viewing', 'television viewing and sugar-sweetened beverage consumption']","['television viewing hours per day', 'Body mass index (BMI) z-score', 'Sugar-sweetened beverage intake']","[{'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0039461', 'cui_str': 'Television'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0039461', 'cui_str': 'Television'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0556974', 'cui_str': 'hours/day (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}]",40.0,0.0476793,"Sugar-sweetened beverage intake was marginally significantly lower among intervention group compared to control group children (0.21 [SE = .09] vs. 0.45 [SE = .10], respectively, P < .09).","[{'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'French', 'Affiliation': 'Division of Epidemiology & Community Health, University of Minnesota, Minneapolis, Minnesota, USA. frenc001@umn.edu.'}, {'ForeName': 'N E', 'Initials': 'NE', 'LastName': 'Sherwood', 'Affiliation': 'HealthPartners Institute for Education and Research, Minneapolis, Minnesota, USA.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'JaKa', 'Affiliation': 'Division of Epidemiology & Community Health, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Haapala', 'Affiliation': 'Division of Epidemiology & Community Health, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'C B', 'Initials': 'CB', 'LastName': 'Ebbeling', 'Affiliation': ""New Balance Foundation Obesity Prevention Center, Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'D S', 'Initials': 'DS', 'LastName': 'Ludwig', 'Affiliation': ""New Balance Foundation Obesity Prevention Center, Boston Children's Hospital, Boston, Massachusetts, USA.""}]",Pediatric obesity,['10.1111/ijpo.12067'] 465,25524327,Effect of low-dose selenium on thyroid autoimmunity and thyroid function in UK pregnant women with mild-to-moderate iodine deficiency.,"PURPOSE Selenium is an essential trace mineral and a component of selenoproteins that are involved in the production of thyroid hormones and in regulating the immune response. We aimed to explore the effect of low-dose selenium supplementation on thyroid peroxidase antibody (TPO-Ab) concentration and thyroid function in pregnant women from a mild-to-moderate iodine-deficient population. METHODS Samples and data were from a secondary analysis of Selenium in PRegnancy INTervention (SPRINT), a double-blind, randomized, placebo-controlled study that recruited 230 women with singleton pregnancies from a UK antenatal clinic at 12 weeks of gestation. Women were randomized to receive 60 µg/day selenium or placebo until delivery. Serum thyroid peroxidase antibodies (TPO-Ab), thyrotropin (TSH) and free thyroxine (FT4) were measured at 12, 20 and 35 weeks and thyroglobulin antibodies (Tg-Ab) at 12 weeks. RESULTS 93.5% of participants completed the study. Se supplementation had no more effect than placebo in decreasing TPO-Ab concentration or the prevalence of TPO-Ab positivity during the course of pregnancy. In women who were either TPO-Ab or Tg-Ab negative at baseline (Thy-Ab(-ve)), TSH increased and FT4 decreased significantly throughout gestation (P < 0.001), with no difference between treatment groups. In women who were Thy-Ab(+ve) at baseline, TSH tended to decrease and was lower than placebo at 35 weeks (P = 0.050). FT4 fell more on Se than placebo supplementation and was significantly lower at 35 weeks (P = 0.029). CONCLUSIONS Low-dose selenium supplementation in pregnant women with mild-to-moderate deficiency had no effect on TPO-Ab concentration, but tended to change thyroid function in Thy-Ab(+ve) women.",2016,Se supplementation had no more effect than placebo in decreasing TPO-Ab concentration or the prevalence of TPO-Ab positivity during the course of pregnancy.,"['230 women with singleton pregnancies from a UK antenatal clinic at 12 weeks of gestation', 'pregnant women with mild-to-moderate deficiency', 'pregnant women from a mild-to-moderate iodine-deficient population', 'UK pregnant women with mild-to-moderate iodine deficiency']","['placebo', 'low-dose selenium supplementation', 'low-dose selenium', '60 µg/day selenium or placebo', 'Low-dose selenium supplementation', 'Selenium in PRegnancy INTervention (SPRINT']","['TPO-Ab concentration', 'TSH increased and FT4', 'Serum thyroid peroxidase antibodies (TPO-Ab), thyrotropin (TSH) and free thyroxine (FT4', 'thyroid autoimmunity and thyroid function', 'thyroid peroxidase antibody (TPO-Ab) concentration and thyroid function']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0342199', 'cui_str': 'Iodine deficiency syndrome (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0586553', 'cui_str': 'Raised TSH level'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1318460', 'cui_str': 'Measurement of thyroperoxidase antibody (procedure)'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0312452', 'cui_str': 'Free thyroxin (substance)'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C0004368', 'cui_str': 'Autoimmunity'}, {'cui': 'C0031843', 'cui_str': 'function'}]",230.0,0.152513,Se supplementation had no more effect than placebo in decreasing TPO-Ab concentration or the prevalence of TPO-Ab positivity during the course of pregnancy.,"[{'ForeName': 'Jinyuan', 'Initials': 'J', 'LastName': 'Mao', 'Affiliation': 'Department of Nutritional Sciences, Faculty of Health and Medical Sciences, University of Surrey, Guildford, GU2 7XH, UK.'}, {'ForeName': 'Victor J', 'Initials': 'VJ', 'LastName': 'Pop', 'Affiliation': 'Department of Clinical Health Psychology, Tilburg University, Tilburg, The Netherlands.'}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Bath', 'Affiliation': 'Department of Nutritional Sciences, Faculty of Health and Medical Sciences, University of Surrey, Guildford, GU2 7XH, UK.'}, {'ForeName': 'Huib L', 'Initials': 'HL', 'LastName': 'Vader', 'Affiliation': 'Clinical Laboratories, Máxima Medical Center Eindhoven, Veldhoven, The Netherlands.'}, {'ForeName': 'Christopher W G', 'Initials': 'CW', 'LastName': 'Redman', 'Affiliation': 'Nuffield Department of Obstetrics and Gynaecology, John Radcliffe Hospital, University of Oxford, Oxford, UK.'}, {'ForeName': 'Margaret P', 'Initials': 'MP', 'LastName': 'Rayman', 'Affiliation': 'Department of Nutritional Sciences, Faculty of Health and Medical Sciences, University of Surrey, Guildford, GU2 7XH, UK. m.rayman@surrey.ac.uk.'}]",European journal of nutrition,['10.1007/s00394-014-0822-9'] 466,25537835,Pharmacokinetics of diluted (U20) insulin aspart compared with standard (U100) in children aged 3-6 years with type 1 diabetes during closed-loop insulin delivery: a randomised clinical trial.,"AIMS/HYPOTHESIS The aim of this study was to compare the pharmacokinetics of two different concentrations of insulin aspart (B28Asp human insulin) in children aged 3-6 years with type 1 diabetes. METHODS Young children with type 1 diabetes underwent an open-label, randomised, two-period crossover study in a clinical research facility, 2-6 weeks apart. In random order, diluted (1:5 dilution with saline [154 mmol/l NaCl]; 20 U/ml) or standard strength (100 U/ml) insulin aspart was administered via an insulin pump as a meal bolus and then overnight by closed-loop insulin delivery as determined by a model predictive algorithm. Plasma insulin was measured every 30-60 min from 17:00 hours on day 1 to 8:00 hours on day 2. We measured the time-to-peak insulin concentration (tmax), insulin metabolic clearance rate (MCR(I)) and background insulin concentration (ins(c)) using compartmental modelling. RESULTS Eleven children (six male; age range 3.75-6.96 years, HbA1c 7.6% ± 1.3% [60 ± 14 mmol/mol], BMI standard deviation score 1.0 ± 0.8, duration of diabetes 2.2 ± 1.0 years, total daily dose 12.9 [10.6-16.5] U, fasting C-peptide concentration 5 [5-17.1] pmol/l; mean ± SD or median [interquartile range]) participated in the study. No differences between standard and diluted insulin were observed in terms of t max (59.2 ± 14.4 vs 61.6 ± 8.7) min for standard vs diluted, p = 0.59; MCR I (1.98 × 10(-2) ± 0.99 × 10(-2) vs 1.89 × 10(-2) ± 0.82 × 10(-2) 1/kg/min, p = 0.47), and ins c (34 [1-72] vs 23 [3-65] pmol/l, p = 0.66). However, t max showed less intersubject variability following administration of diluted aspart (SD 14.4 vs 8.7 min, p = 0.047). CONCLUSIONS/INTERPRETATION Diluting insulin aspart does not change its pharmacokinetics. However, it may result in less variable absorption and could be used in young children with type 1 diabetes undergoing closed-loop insulin delivery. TRIAL REGISTRATION Clinicaltrials.gov NCT01557634. FUNDING FUNDING was provided by the JDRF, 7th Framework Programme of the European Union, Wellcome Trust Strategic Award and the National Institute for Health Research Cambridge Biomedical Research Centre.",2015,"No differences between standard and diluted insulin were observed in terms of t max (59.2 ± 14.4 vs 61.6 ± 8.7) min for standard vs diluted, p = 0.59; MCR I (1.98 × 10(-2) ± 0.99 × 10(-2) vs 1.89 × 10(-2) ± 0.82 × 10(-2) 1/kg/min, p = 0.47), and ins c (34 [1-72] vs 23 [3-65] pmol/l, p = 0.66).","['Eleven children (six male; age range 3.75-6.96 years, HbA1c 7.6% ± 1.3% [60 ± 14 mmol/mol], BMI standard deviation score 1.0 ± 0.8, duration of diabetes 2.2 ± 1.0 years, total daily dose', 'children aged 3-6 years with type 1 diabetes during closed-loop insulin delivery', 'Young children with type 1 diabetes underwent an', 'children aged 3-6 years with type 1 diabetes', 'young children with type 1 diabetes undergoing closed-loop insulin delivery']","['Diluting insulin aspart', 'diluted (U20) insulin aspart compared with standard (U100', 'diluted (1:5 dilution with saline [154 mmol/l NaCl]; 20 U/ml) or standard strength (100 U/ml) insulin aspart was administered via an insulin pump', 'insulin aspart (B28Asp human insulin', 'open-label']","['standard and diluted insulin', 'Plasma insulin', 'time-to-peak insulin concentration (tmax), insulin metabolic clearance rate (MCR(I)) and background insulin concentration (ins(c)) using compartmental modelling']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517697', 'cui_str': 'Three point seven five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C0445022', 'cui_str': 'Loop (qualifier value)'}]","[{'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0079240', 'cui_str': 'Dilution Technics'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C2945590', 'cui_str': 'unit/mL'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0795635', 'cui_str': 'insulin (human)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0025515', 'cui_str': 'Metabolic Clearance Rate'}]",11.0,0.237881,"No differences between standard and diluted insulin were observed in terms of t max (59.2 ± 14.4 vs 61.6 ± 8.7) min for standard vs diluted, p = 0.59; MCR I (1.98 × 10(-2) ± 0.99 × 10(-2) vs 1.89 × 10(-2) ± 0.82 × 10(-2) 1/kg/min, p = 0.47), and ins c (34 [1-72] vs 23 [3-65] pmol/l, p = 0.66).","[{'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Ruan', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Elleri', 'Affiliation': ''}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Allen', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Tauschmann', 'Affiliation': ''}, {'ForeName': 'Malgorzata E', 'Initials': 'ME', 'LastName': 'Wilinska', 'Affiliation': ''}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Dunger', 'Affiliation': ''}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hovorka', 'Affiliation': ''}]",Diabetologia,['10.1007/s00125-014-3483-6'] 467,32120419,Controlled Release Dinoprostone Insert and Foley Compared to Foley Alone: A Randomized Pilot Trial.,"OBJECTIVE The aim of study is to compare, in a pilot study, combined dinoprostone vaginal insert and Foley catheter (DVI + Foley) with Foley alone (Foley) for cervical ripening and labor induction at term. STUDY DESIGN In this open-label pilot randomized controlled trial, women not in labor, with intact membranes, no prior uterine incision, an unfavorable cervix, gestational age ≥37 weeks, and a live, nonanomalous singleton fetus in cephalic presentation were randomly assigned, stratified by parity, to DVI + Foley or Foley. Oxytocin was used in both groups after cervical ripening. Primary outcome was time to vaginal delivery. RESULTS From April 2017 to January 2018, 100 women were randomized. Median (25-75th percentile) time to vaginal delivery for nulliparous women was 21.2 (16.6-38.0) hours with DVI + Foley ( n  = 26) compared with 31.3 (23.3-46.9) hours with Foley ( n  = 24) (Wilcoxon p  = 0.05). Median time to vaginal delivery for parous women was 17.1 (13.6-21.9) hours with DVI + Foley ( n  = 25) compared with 14.8 (12.7-19.5) hours with Foley ( n  = 25) (Wilcoxon p  = 0.21). Results were also analyzed to consider the competing risk of cesarean using cumulative incidence functions. CONCLUSION Compared with Foley alone, combined use of the dinoprostone vaginal insert and Foley for cervical ripening may shorten time to vaginal delivery for nulliparous but not parous women.",2020,Median time to vaginal delivery for parous women was 17.1 (13.6-21.9) hours with DVI + Foley ( n  = 25) compared with 14.8 (12.7-19.5) hours with Foley ( n  = 25) (,"['women not in labor, with intact membranes, no prior uterine incision, an unfavorable cervix, gestational age ≥37 weeks, and a live, nonanomalous singleton fetus in cephalic presentation', 'From April 2017 to January 2018, 100 women were randomized', 'nulliparous but not parous women']","['dinoprostone vaginal insert and Foley catheter (DVI\u2009+\u2009Foley) with Foley alone (Foley', 'dinoprostone vaginal insert and Foley for cervical ripening', 'Dinoprostone Insert and Foley Compared to Foley Alone', 'DVI\u2009+\u2009Foley or Foley', 'Oxytocin']","['Median time to vaginal delivery', 'time to vaginal delivery']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0426199', 'cui_str': 'Intact membranes (finding)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0007874', 'cui_str': 'Uterine Cervix'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0015965', 'cui_str': 'Fetus'}, {'cui': 'C2979973'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous (finding)'}]","[{'cui': 'C0012472', 'cui_str': 'prostaglandin E2 alpha'}, {'cui': 'C1719963', 'cui_str': 'Conventional release vaginal insert'}, {'cui': 'C0179804'}, {'cui': 'C0600454', 'cui_str': 'Ripenings, Cervical'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}]",100.0,0.185456,Median time to vaginal delivery for parous women was 17.1 (13.6-21.9) hours with DVI + Foley ( n  = 25) compared with 14.8 (12.7-19.5) hours with Foley ( n  = 25) (,"[{'ForeName': 'Rodney K', 'Initials': 'RK', 'LastName': 'Edwards', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oklahoma College of Medicine, Oklahoma City, Oklahoma.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Norris', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oklahoma College of Medicine, Oklahoma City, Oklahoma.'}, {'ForeName': 'Mitchell D', 'Initials': 'MD', 'LastName': 'West', 'Affiliation': 'Department of Obstetrics and Gynecology, Louisiana State University Health Sciences Center, Shreveport, Louisiana.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Zornes', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oklahoma College of Medicine, Oklahoma City, Oklahoma.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Loeffler', 'Affiliation': 'School of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'Peck', 'Affiliation': 'School of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}]",American journal of perinatology,['10.1055/s-0040-1705113'] 468,31550381,"Using Goal Setting and Attainment to Impact Indicators of Health Behavior Change among Young American Indian Women: The We RISE (Raising Income, Supporting Education) Study.","The purpose of the present study was to assess the association between setting and attaining goals and indicators of health behavior change (psychological general well-being index, self-efficacy, and health locus of control) among young American Indian mothers. A total of 60 women were randomized to either intervention or control. At the end of the 6-month intervention, goal attainment was not significantly associated with the three outcomes of interest. However, resource program contacts and goal track were associated with confidence in completing goals and health locus of control internality, respectively. Lessons learned and future research needs are discussed.",2019,"At the end of the 6-month intervention, goal attainment was not significantly associated with the three outcomes of interest.","['A total of 60 women', 'Young American Indian Women', 'young American Indian mothers']",['intervention or control'],"['health behavior change (psychological general well-being index, self-efficacy, and health locus of control']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0002460', 'cui_str': 'American Indians'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0018687'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C2939150', 'cui_str': 'General wellbeing (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023953', 'cui_str': 'Locus of Control'}]",60.0,0.0241732,"At the end of the 6-month intervention, goal attainment was not significantly associated with the three outcomes of interest.","[{'ForeName': 'Lacey A', 'Initials': 'LA', 'LastName': 'McCormack', 'Affiliation': ''}, {'ForeName': 'Rae', 'Initials': 'R', 'LastName': ""O'Leary"", 'Affiliation': ''}, {'ForeName': 'Alli', 'Initials': 'A', 'LastName': 'Moran', 'Affiliation': ''}, {'ForeName': 'Christine W', 'Initials': 'CW', 'LastName': 'Hockett', 'Affiliation': ''}]",American Indian and Alaska native mental health research (Online),['10.5820/aian.2602.2019.123'] 469,32416978,"Randomized, assessor-blinded trial comparing highly purified human menotropin and recombinant follicle-stimulating hormone in high responders undergoing intracytoplasmic sperm injection.","OBJECTIVE To evaluate the efficacy and safety of highly purified human menotropin (HP-hMG) and recombinant follicle-stimulating hormone (rFSH) for controlled ovarian stimulation in a population of patients predicted to be high responders. DESIGN Randomized, open-label, assessor-blinded, parallel-group, noninferiority trial. SETTING Fertility centers. PATIENT(S) A total of 620 women with serum antimüllerian hormone (AMH) ≥5 ng/mL. INTERVENTION(S) Controlled ovarian stimulation with HP-hMG or rFSH in a GnRH antagonist assisted reproductive technology (ART) cycle. Fresh transfer of a single blastocyst was performed unless ovarian response was excessive, in which all embryos were cryopreserved. Subjects could undergo subsequent frozen blastocyst transfer within 6 months of randomization. MAIN OUTCOME MEASURE(S) Ongoing pregnancy rate (OPR) after fresh transfer (primary endpoint), as well as cumulative live birth, ovarian hyperstimulation syndrome (OHSS), and pregnancy loss rates. RESULTS OPR/cycle start after fresh transfer was 35.5% with HP-hMG and 30.7% with rFSH (difference: 4.7%, 95% CI -2.7%, 12.1%); noninferiority was established. Compared to rFSH, HP-hMG was associated with significantly lower OHSS (21.4% vs. 9.7% respectively; difference: -11.7%, 95% CI -17.3%, -6.1%) and cumulative early pregnancy loss rates (25.5% vs. 14.5% respectively; difference: -11.0%, 95% CI -18.8%, -3.14%). Despite 43 more transfers in the rFSH group, cumulative live birth rates were similar with HP-hMG and rFSH at 50.6% and 51.5% respectively (difference: -0.8%, 95% CI -8.7%, 7.1%). CONCLUSION(S) In high responders, HP-hMG provided comparable efficacy to rFSH with fewer adverse events, including pregnancy loss, suggesting its optimized risk/benefit profile in this population. CLINICAL TRIAL REGISTRATION NUMBER NCT02554279 (clinicaltrials.gov).",2020,"Despite 43 more transfers in the rFSH group, cumulative live birth rates were similar with HP-hMG and rFSH at 50.6% and 51.5% respectively (difference:","['high responders undergoing intracytoplasmic sperm injection', '620 women with serum antimüllerian hormone (AMH) ≥5', 'Fertility centers']","['HP-hMG or rFSH', 'highly purified human menotropin (HP-hMG) and recombinant follicle-stimulating hormone (rFSH', 'purified human menotropin and recombinant follicle-stimulating hormone', 'rFSH']","['cumulative early pregnancy loss rates', 'pregnancy loss', 'OHSS', 'Ongoing pregnancy rate (OPR', 'efficacy and safety', 'subsequent frozen blastocyst transfer', 'cumulative live birth rates', 'cumulative live birth, ovarian hyperstimulation syndrome (OHSS), and pregnancy loss rates']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C4708788', 'cui_str': '620'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0025326', 'cui_str': 'human menopausal gonadotrophin'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}]","[{'cui': 'C3830362', 'cui_str': 'Early Pregnancy Loss'}, {'cui': 'C0156543', 'cui_str': 'Pregnancy with abortive outcome'}, {'cui': 'C0085083', 'cui_str': 'Ovarian hyperstimulation syndrome'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0936221', 'cui_str': 'Blastocyst Transfer'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}]",620.0,0.661804,"Despite 43 more transfers in the rFSH group, cumulative live birth rates were similar with HP-hMG and rFSH at 50.6% and 51.5% respectively (difference:","[{'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Witz', 'Affiliation': 'Houston Fertility Institute, Houston, Texas.'}, {'ForeName': 'Gaurang S', 'Initials': 'GS', 'LastName': 'Daftary', 'Affiliation': 'Ferring Pharmaceuticals, Inc., Parsippany, New Jersey.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Doody', 'Affiliation': 'Center for Assisted Reproduction, Bedford, Texas.'}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Park', 'Affiliation': 'Carolina Conceptions, Raleigh, North Carolina.'}, {'ForeName': 'Yodit', 'Initials': 'Y', 'LastName': 'Seifu', 'Affiliation': 'Ferring Pharmaceuticals, Inc., Parsippany, New Jersey.'}, {'ForeName': 'Vladimir I', 'Initials': 'VI', 'LastName': 'Yankov', 'Affiliation': 'Ferring Pharmaceuticals, Inc., Parsippany, New Jersey.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Heiser', 'Affiliation': 'Ferring Pharmaceuticals, Inc., Parsippany, New Jersey. Electronic address: Patrick.Heiser@ferring.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Fertility and sterility,['10.1016/j.fertnstert.2020.03.029'] 470,32416981,Are narcotic pain medications necessary after discharge following thyroidectomy and parathyroidectomy?,"BACKGROUND The aim of this study was to determine whether patients undergoing thyroidectomy and parathyroidectomy have similar postoperative pain if managed with an opioid-sparing regimen versus an opioid-containing regimen. We hypothesized that an opioid-sparing regimen would provide equivalent analgesia. METHODS We performed a prospective, randomized trial (clinicaltrials.govNCT03640247) comparing non-narcotic and narcotic postoperative pain regimens after discharge. Patients ≥18 y undergoing thyroidectomy or parathyroidectomy were eligible for inclusion. Patients were excluded if they were taking a narcotic. Patients in the nonnarcotic arm of the study received acetaminophen, alternating with ibuprofen, and patients in the narcotic arm received the same medications plus a narcotic. RESULTS Of 126 patients, 64 patients were in the nonnarcotic group and 62 were in the narcotic group. The mean age was 54 ± 14 y, and 108 (86%) patients were female. Median pain scores were similar on postoperative day #0 (narcotic group 7 versus nonnarcotic group 7.5), postoperative day #1 (narcotic group 6 versus nonnarcotic group 6), postoperative day #2 (narcotic group 5 versus nonnarcotic group 5), postoperative day #3 (narcotic group 4 versus nonnarcotic group 4), postoperative day #4 (narcotic group 3 versus nonnarcotic 3) and postoperative day #5 (narcotic group 2.5 versus nonnarcotic group 2, all P > .1). A total of 31 (50%) patients in the narcotic group did not take a narcotic. A total of 8 (12.5%) patients in the nonnarcotic group and of 31 (50%) patients in the narcotic group took a median total of 2 narcotic tablets. CONCLUSION An opioid-sparing pain medication regimen provides effective analgesia for most patients after thyroidectomy and parathyroidectomy.",2021,"Median pain scores were similar on postoperative day #0 (narcotic group 7 versus nonnarcotic group 7.5), postoperative day #1 (narcotic group 6 versus nonnarcotic group 6), postoperative day #2 (narcotic group 5 versus nonnarcotic group 5), postoperative day #3 (narcotic group 4 versus nonnarcotic group 4), postoperative day #4 (narcotic group 3 versus nonnarcotic 3) and postoperative day #5 (narcotic group 2.5 versus nonnarcotic group 2, all P > .1).","['64 patients were in the nonnarcotic group and 62 were in the narcotic group', 'non-narcotic and narcotic postoperative pain regimens after discharge', 'Patients ≥18 y undergoing thyroidectomy or parathyroidectomy were eligible for inclusion', 'The mean age was 54 ± 14 y, and 108 (86%) patients were female', 'patients undergoing', '126 patients']","['opioid-sparing regimen versus an opioid-containing regimen', 'acetaminophen, alternating with ibuprofen', 'narcotic arm received the same medications plus a narcotic', 'thyroidectomy and parathyroidectomy', 'opioid-sparing pain medication regimen', 'opioid-sparing regimen']",['Median pain scores'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0079989', 'cui_str': 'Parathyroidectomy'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0470256', 'cui_str': '126'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0079989', 'cui_str': 'Parathyroidectomy'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",64.0,0.0398099,"Median pain scores were similar on postoperative day #0 (narcotic group 7 versus nonnarcotic group 7.5), postoperative day #1 (narcotic group 6 versus nonnarcotic group 6), postoperative day #2 (narcotic group 5 versus nonnarcotic group 5), postoperative day #3 (narcotic group 4 versus nonnarcotic group 4), postoperative day #4 (narcotic group 3 versus nonnarcotic 3) and postoperative day #5 (narcotic group 2.5 versus nonnarcotic group 2, all P > .1).","[{'ForeName': 'Justin T', 'Initials': 'JT', 'LastName': 'Brady', 'Affiliation': 'MetroHealth Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Angelina', 'Initials': 'A', 'LastName': 'Dreimiller', 'Affiliation': 'MetroHealth Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Miller-Spalding', 'Affiliation': 'MetroHealth Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Gesang', 'Affiliation': 'MetroHealth Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Ashwini R', 'Initials': 'AR', 'LastName': 'Sehgal', 'Affiliation': 'MetroHealth Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'McHenry', 'Affiliation': 'MetroHealth Medical Center, Cleveland, OH, USA. Electronic address: cmchenry@metrohealth.org.'}]",Surgery,['10.1016/j.surg.2020.03.027'] 471,32417348,Concurrent cisplatin and dose escalation with intensity-modulated radiotherapy (IMRT) versus conventional radiotherapy for locally advanced head and neck squamous cell carcinomas (HNSCC): GORTEC 2004-01 randomized phase III trial.,"BACKGROUND Concurrent chemoradiotherapy (CRT) is the standard of care (SoC) in locally advanced (LA) head and neck squamous cell carcinomas (HNSCC). This trial was designed to test whether dose-escalated IMRT and cisplatin could improve locoregional control without increasing complications over 3D-radiotherapy. METHODS Patients were randomized between 70 Gy/35F in 7 weeks with 3D-RT (Arm A) versus 75 Gy/35F with IMRT (Arm B). Both arms received 50 Gy in 25 fractions followed by a sequential boost of 20 Gy/10F in Arm A and 25 Gy/10F to gross tumor volume in Arm B, as well as 3 cycles of cisplatin at 100 mg/m2 during RT. The primary endpoint was locoregional progression (LRP). RESULTS 188 patients were randomized: 85% oropharynx and 73% stage IVa. P16 status was documented for 137 oropharyngeal tumors with P16+ in 53 (39%) patients; and 90% were smokers. Median follow-up was 60.5 months. Xerostomia was markedly decreased in arm B (p < 0.0001). The 1-year grade ≥2 xerostomia (RTOG criteria) was 63% vs 23% and 3-year 45% vs 11% in arms A and B, respectively. Xerostomia LENT-SOMA scale was also reduced in arm B. Dose-escalated IMRT did not reduce LRP with an adjusted HR of 1.13 [95%CI = 0.64-1.98] (p = 0.68). Survival was not different (adjusted HR: 1.19 [95%CI = 0.78-1.81], p = 0.42). No interaction between p16 and treatment effect was found. CONCLUSION Dose-escalated IMRT did not improve LRC in LA-HNSCC patients treated with concomitant CRT over standard 3D-RT. This trial reinforces the evidence showing IMRT reduces xerostomia in LA-HNSCC treated with radiotherapy. Clinicaltrial.gov: NCT00158678.",2020,"CONCLUSION Dose-escalated IMRT did not improve LRC in LA-HNSCC patients treated with concomitant CRT over standard 3D-RT.","['locally advanced (LA) head and neck squamous cell carcinomas (HNSCC', '188 patients were randomized: 85% oropharynx and 73% stage IVa', 'patients', 'locally advanced head and neck squamous cell carcinomas (HNSCC']","['Concurrent chemoradiotherapy (CRT', 'radiotherapy', 'Concurrent cisplatin and Dose escalation with Intensity-modulated radiotherapy (IMRT', 'cisplatin', 'conventional radiotherapy', 'IMRT and cisplatin', '75Gy/35F with IMRT']","['1-year grade ≥ 2 xerostomia (RTOG criteria', 'Xerostomia LENT-SOMA scale', 'Survival', 'P16 status', 'Xerostomia', 'locoregional progression (LRP', 'xerostomia']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0441773', 'cui_str': 'Stage IVa'}]","[{'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C1512814', 'cui_str': 'Intensity modulated radiation therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0702216', 'cui_str': 'Soma'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0249880', 'cui_str': 'Cdk4-Associated Protein p16'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",188.0,0.356655,"CONCLUSION Dose-escalated IMRT did not improve LRC in LA-HNSCC patients treated with concomitant CRT over standard 3D-RT.","[{'ForeName': 'Yungan', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France. Electronic address: yungan.tao@gustaveroussy.fr.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Auperin', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France; INSERM 1018, Villefjuif, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Blanchard', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Alfonsi', 'Affiliation': 'Institut Sainte Catherine, Avignon, France.'}, {'ForeName': 'Xu-Shan', 'Initials': 'XS', 'LastName': 'Sun', 'Affiliation': 'Hopital Nord Franche-Comté de Montbéliard & CHRU de Besançon, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Rives', 'Affiliation': 'Institut Claudius Regaud, Toulouse, France.'}, {'ForeName': 'Yoann', 'Initials': 'Y', 'LastName': 'Pointreau', 'Affiliation': 'Centre Jean Bernard, Le Mans, France.'}, {'ForeName': 'Joël', 'Initials': 'J', 'LastName': 'Castelli', 'Affiliation': 'Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Graff', 'Affiliation': 'Institut Claudius Regaud, Toulouse, France; Centre Alexis Vautrin, Nancy, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Wong Hee Kam', 'Affiliation': 'AP-HM Hôpital de la Timone, Marseille, France.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Thariat', 'Affiliation': 'Centre Antoine Lacassagne, Nice, France; Centre francois Baclesse, Caen, France.'}, {'ForeName': 'Ovidiu', 'Initials': 'O', 'LastName': 'Veresezan', 'Affiliation': 'Centre Henri Becquerel, Rouen, France.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Heymann', 'Affiliation': 'Clinique Sainte Anne, Strasbourg, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Renard-Oldrini', 'Affiliation': 'Centre Alexis Vautrin, Nancy, France.'}, {'ForeName': 'Cédrik', 'Initials': 'C', 'LastName': 'Lafond', 'Affiliation': 'Centre Jean Bernard, Le Mans, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Cornely', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France.'}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Casiraghi', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Boisselier', 'Affiliation': 'Centre Eugène Marquis, Rennes, France; Institut du Cancer de Montpellier, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Lapeyre', 'Affiliation': 'Centre Alexis Vautrin, Nancy, France; Centre Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Biau', 'Affiliation': 'Centre Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bourhis', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France; CHUV Lausanne, Switzerland. Electronic address: jean.bourhis@chuv.ch.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.05.021'] 472,32417564,Sham Surgery Studies in Orthopaedic Surgery May Just Be a Sham: A Systematic Review of Randomized Placebo-Controlled Trials.,"PURPOSE To determine the limitations of randomized sham surgery-controlled trials in orthopaedic sports medicine and fidelity of the trials' conclusions. METHODS Randomized placebo surgery-controlled trials in orthopaedic sports medicine were included in this Preferred Reporting Items for Systematic Reviews and Meta-Analyses-guided systematic review. Several aspects of investigation design and conduct were analyzed: genetic analysis for propensity to placebo response, equipoise of informed consent process, geography of trial subjects, percentage of eligible subjects willing to be randomized, changes from protocol publication to results publication, and perioperative complications. RESULTS Seven sham surgery-controlled trials (845 subjects [370 knees, 449 shoulders, 26 elbows]; 5 from Europe, 1 from North America, and 1 from Australia; all superiority model, efficacy design) were analyzed. There were consistent methodologic deficiencies across studies. No studies reported genetic analysis of susceptibility to placebo response. Three studies (43%) were underpowered. Crossover rates ranged from 8% to 36%, which led to un-blinding in up to 100% of subjects. There were low enrollment rates of eligible subjects (up to 57% refused randomization). Follow-up was short term (2 years or less in all but one study). Complication rates ranged from 0% to 12.5%, with complications occurring in both groups (no significant difference between groups in any study). CONCLUSIONS Randomized sham-controlled studies in orthopaedic sports medicine have significant methodologic deficiencies that may invalidate their conclusions. Randomized trial design (with or without placebo control) may be optimized through the inclusion of per-protocol analysis, blinding index, equivalence or noninferiority trial design, and a nontreatment group. LEVEL OF EVIDENCE Level II Systematic Review of Level II studies.",2020,"Complication rates ranged from 0% to 12.5% with complications occurring in both groups (no significant difference between groups in any study). ","['orthopedic sports medicine', 'Seven sham surgery-controlled trials (845 subjects [370 knees, 449 shoulders, 26 elbows]; five Europe, one North America, one Australia', 'Orthopedic Surgery']","['Placebo', 'placebo']",['Complication rates'],"[{'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0038040', 'cui_str': 'Medicine, Sport'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}]",845.0,0.715691,"Complication rates ranged from 0% to 12.5% with complications occurring in both groups (no significant difference between groups in any study). ","[{'ForeName': 'Kyle R', 'Initials': 'KR', 'LastName': 'Sochacki', 'Affiliation': 'Houston Methodist Orthopedic and Sports Medicine, Houston, Texas, U.S.A.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Mather', 'Affiliation': 'Department of Orthopaedic Surgery, Duke University School of Medicine, Durham, North Carolina, U.S.A.'}, {'ForeName': 'Benedict U', 'Initials': 'BU', 'LastName': 'Nwachukwu', 'Affiliation': 'Hospital for Special Surgery, New York, New York, U.S.A.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dong', 'Affiliation': 'Houston Methodist Orthopedic and Sports Medicine, Houston, Texas, U.S.A.'}, {'ForeName': 'Shane J', 'Initials': 'SJ', 'LastName': 'Nho', 'Affiliation': 'Section of Young Adult Hip Surgery, Division of Sports Medicine, Department of Orthopedic Surgery, Rush University Medical Center, Chicago, Illinois, U.S.A.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Cote', 'Affiliation': 'UConn Musculoskeletal Institute at UConn Health, Farmington, Connecticut, U.S.A.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Harris', 'Affiliation': 'Houston Methodist Orthopedic and Sports Medicine, Houston, Texas, U.S.A.. Electronic address: joshuaharrismd@gmail.com.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2020.05.001'] 473,25414048,No evidence of disease activity: indirect comparisons of oral therapies for the treatment of relapsing-remitting multiple sclerosis.,"INTRODUCTION No head-to-head trials have compared the efficacy of the oral therapies, fingolimod, dimethyl fumarate and teriflunomide, in multiple sclerosis. Statistical modeling approaches, which control for differences in patient characteristics, can improve indirect comparisons of the efficacy of these therapies. METHODS No evidence of disease activity (NEDA) was evaluated as the proportion of patients free from relapses and 3-month confirmed disability progression (clinical composite), free from gadolinium-enhancing T1 lesions and new or newly enlarged T2 lesions (magnetic resonance imaging composite), or free from all disease measures (overall composite). For each measure, the efficacy of fingolimod was estimated by analyzing individual patient data from fingolimod phase 3 trials using methodologies from studies of other oral therapies. These data were then used to build binomial regression models, which adjusted for differences in baseline characteristics between the studies. Models predicted the indirect relative risk of achieving NEDA status for fingolimod versus dimethyl fumarate or teriflunomide in an average patient from their respective phase 3 trials. RESULTS The estimated relative risks of achieving NEDA status for fingolimod versus placebo in a pooled fingolimod trial population were numerically greater (i.e., fingolimod more efficacious) than the estimated relative risks for dimethyl fumarate or teriflunomide versus placebo in each respective trial population. In indirect comparisons, the predicted relative risks for all composite measures were better for fingolimod than comparator when tested against the trial populations of those treated with dimethyl fumarate (relative risk, clinical: 1.21 [95% confidence interval 1.06-1.39]; overall: 1.67 [1.08-2.57]), teriflunomide 7 mg (clinical: 1.22 [1.02-1.46]; overall: 2.01 [1.38-2.93]) and teriflunomide 14 mg (clinical: 1.14 [0.96-1.36]; overall: 1.61 [1.12-2.31]). CONCLUSION Our modeling approach suggests that fingolimod therapy results in a higher probability of NEDA than dimethyl fumarate and teriflunomide therapy when phase 3 trial data are indirectly compared and differences between trials are adjusted for.",2014,"In indirect comparisons, the predicted relative risks for all composite measures were better for fingolimod than comparator when tested against the trial populations of those treated with dimethyl fumarate (relative risk, clinical: 1.21 [95% confidence interval 1.06-1.39]; overall: 1.67 [1.08-2.57]), teriflunomide 7 mg (clinical: 1.22 [1.02-1.46]; overall: 2.01 [1.38-2.93]) and teriflunomide 14 mg (clinical: 1.14 [0.96-1.36]; overall: 1.61 [1.12-2.31]). ",['relapsing-remitting multiple sclerosis'],['placebo'],"['disease activity (NEDA', 'efficacy of fingolimod']","[{'cui': 'C0751967', 'cui_str': 'Multiple Sclerosis, Relapsing-Remitting'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}]",,0.186888,"In indirect comparisons, the predicted relative risks for all composite measures were better for fingolimod than comparator when tested against the trial populations of those treated with dimethyl fumarate (relative risk, clinical: 1.21 [95% confidence interval 1.06-1.39]; overall: 1.67 [1.08-2.57]), teriflunomide 7 mg (clinical: 1.22 [1.02-1.46]; overall: 2.01 [1.38-2.93]) and teriflunomide 14 mg (clinical: 1.14 [0.96-1.36]; overall: 1.61 [1.12-2.31]). ","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Nixon', 'Affiliation': 'Novartis Pharma AG, Postfach, 4002, Basel, Switzerland, richard.nixon@novartis.com.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Bergvall', 'Affiliation': ''}, {'ForeName': 'Davorka', 'Initials': 'D', 'LastName': 'Tomic', 'Affiliation': ''}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Sfikas', 'Affiliation': ''}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Cutter', 'Affiliation': ''}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Giovannoni', 'Affiliation': ''}]",Advances in therapy,['10.1007/s12325-014-0167-z'] 474,25135394,Medical Costs of Oral Anticoagulants vs Warfarin for Atrial Fibrillation Patients with Different Stroke Risks.,"INTRODUCTION The Apixaban for the Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE), Randomized Evaluation of Long-term Anticoagulation Therapy (RE-LY), and Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET-AF) trials demonstrated that the oral anticoagulants (OACs), apixaban, dabigatran, and rivaroxaban, respectively, are efficacious for stroke prevention among nonvalvular atrial fibrillation (NVAF) patients. Based on clinical trial results this study evaluated medical costs of clinical events associated with use of individual OACs relative to those of warfarin in NVAF patients with moderate and high stroke risk. METHODS Rates for primary and secondary efficacy and safety outcomes (i.e., clinical events) among NVAF patients with CHADS2 = 2 and ≥3 were determined from the three OAC trials. One-year incremental costs among patients with clinical events from a US payer perspective were obtained from the literature and inflation adjusted to 2010 costs. Medical costs for clinical events associated with each OAC vs. warfarin were estimated and compared. RESULTS For NVAF patients with moderate stroke risk (CHADS2 = 2) differences in clinical event medical costs vs. warfarin were -$298, -$143, and +$117 per patient year for apixaban, dabigatran (150 mg), and rivaroxaban, respectively (negative numbers indicate cost reduction). For NVAF patients with high stroke risk (CHADS2 ≥ 3) differences in clinical event medical costs vs. warfarin were -$697, +$2, and -$100 for apixaban, dabigatran (150 mg), and rivaroxaban, respectively. CONCLUSIONS Medical cost differences associated with OACs vs. warfarin vary according to stroke risk. Of the three OACs, apixaban demonstrated consistent medical cost reductions vs. warfarin for NVAF patients with moderate and high stroke risks.",2013,"Of the three OACs, apixaban demonstrated consistent medical cost reductions vs. warfarin for NVAF patients with moderate and high stroke risks.","['Atrial Fibrillation', 'NVAF patients with moderate and high stroke risk', 'Atrial Fibrillation Patients with Different Stroke Risks', 'NVAF patients with moderate and high stroke risks', 'patients with CHADS2\xa0=\xa02 and ≥3 were determined from the three OAC trials', 'nonvalvular atrial fibrillation (NVAF) patients']","['NVAF', 'Oral Anticoagulants vs Warfarin', 'Oral Direct Factor Xa Inhibition', 'warfarin', 'Rivaroxaban', 'Vitamin K Antagonism', 'oral anticoagulants (OACs), apixaban, dabigatran, and rivaroxaban', 'Apixaban', 'rivaroxaban', 'OACs vs. warfarin', 'OAC vs. warfarin']",['clinical event medical costs vs. warfarin'],"[{'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1277291', 'cui_str': 'Stroke risk'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0015520', 'cui_str': 'Factor 10A'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0042879', 'cui_str': 'Vitamin K measurement (procedure)'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]",,0.0612315,"Of the three OACs, apixaban demonstrated consistent medical cost reductions vs. warfarin for NVAF patients with moderate and high stroke risks.","[{'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Deitelzweig', 'Affiliation': 'Ochsner Medical Center, New Orleans, LA, USA, sdeitelzweig@ochsner.org.'}, {'ForeName': 'Alpesh', 'Initials': 'A', 'LastName': 'Amin', 'Affiliation': ''}, {'ForeName': 'Yonghua', 'Initials': 'Y', 'LastName': 'Jing', 'Affiliation': ''}, {'ForeName': 'Dinara', 'Initials': 'D', 'LastName': 'Makenbaeva', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wiederkehr', 'Affiliation': ''}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Graham', 'Affiliation': ''}]",Cardiology and therapy,['10.1007/s40119-013-0020-5'] 475,25135811,Effect of topical loteprednol on intraocular pressure after selective laser trabeculoplasty for open-angle glaucoma.,"INTRODUCTION To determine whether there is a statistically significant difference in the decrease in intraocular pressure (IOP) after selective laser trabeculoplasty (SLT) between patients receiving a 5-7 days co-administration of loteprednol versus no loteprednol over the course of 1 year. METHODS We conducted a retrospective chart review to evaluate use of loteprednol in patients aged 30-85 years undergoing SLT for open-angle glaucoma at our center over a 3-year period. RESULTS Three hundred and eighteen eyes from 313 patients who underwent a 360° SLT treatment between January 2008 and August 2011 were included in the analysis. Patients who received loteprednol showed a mean reduction of 2.5 (±SE 0.3) mmHg or 11.8% (±1.5%) in IOP versus a mean reduction of 3.2 (±0.6) mmHg or 14.9% (±2.5%) in those not treated with loteprednol. This difference showed a trend toward lower IOP without loteprednol, but this was not statistically significant (p = 0.29). CONCLUSION Postoperative use of loteprednol does not appear to significantly affect IOP in patients undergoing SLT. A randomized double-blinded study in a larger group of patients would be required to clarify this issue. Until such information is available, we recommend that individual clinical judgment be used regarding whether to use topical steroids in patients undergoing SLT.",2013,"This difference showed a trend toward lower IOP without loteprednol, but this was not statistically significant (p = 0.29). ","['open-angle glaucoma', 'patients aged 30-85\xa0years undergoing SLT for open-angle glaucoma at our center over a 3-year period', 'Three hundred and eighteen eyes from 313 patients who underwent a 360° SLT treatment between January 2008 and August 2011 were included in the analysis', 'patients undergoing SLT']","['loteprednol versus no loteprednol', 'topical loteprednol', 'selective laser trabeculoplasty', 'loteprednol', 'selective laser trabeculoplasty (SLT']","['intraocular pressure', 'intraocular pressure (IOP']","[{'cui': 'C0017612', 'cui_str': 'Glaucoma, Compensated'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205136', 'cui_str': 'Over (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0772364', 'cui_str': 'Loteprednol'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C1271447', 'cui_str': 'SLT - selective laser trabeculoplasty'}]","[{'cui': 'C0021888', 'cui_str': 'Ocular Tension'}]",,0.17219,"This difference showed a trend toward lower IOP without loteprednol, but this was not statistically significant (p = 0.29). ","[{'ForeName': 'Ronald L', 'Initials': 'RL', 'LastName': 'Rebenitsch', 'Affiliation': 'University of Missouri-Kansas City School of Medicine, Kansas City, MO, USA, lrebenitsch@gmail.com.'}, {'ForeName': 'Eric N', 'Initials': 'EN', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Nick R', 'Initials': 'NR', 'LastName': 'Binder', 'Affiliation': ''}, {'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Jani', 'Affiliation': ''}, {'ForeName': 'Aaron J', 'Initials': 'AJ', 'LastName': 'Bonham', 'Affiliation': ''}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Krishna', 'Affiliation': ''}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Pikey', 'Affiliation': ''}]",Ophthalmology and therapy,['10.1007/s40123-013-0018-z'] 476,25135812,Behavior of intraocular pressure after intravitreal injection of triamcinolone acetonide among egyptians.,"PURPOSE To evaluate the changes in intraocular pressure (IOP) after intravitreal injection of triamcinolone acetonide for the management of diabetic macular edema (DME). METHODS The study design is a prospective, interventional, two-arm, dose-response study. Nineteen patients with bilateral DME were included, one eye for every patient underwent intravitreal injection of 4 mg triamcinolone acetonide (group A, 19 eyes), and the other eye of the same patient underwent intravitreal injection of 8 mg triamcinolone acetonide (group B, 19 eyes); the selection as to which eye was to receive either dose was random. The patients were followed up for 6 months after injection; complete ophthalmological examination and optical coherent topography were done. RESULTS Intravitreal triamcinolone acetonide was effective in reduction of DME in group A in the first 3 months only, while in group B with high dose (8 mg) the improvement continued for 6 months after injection. Significant IOP rise was observed in both groups with an incidence of 68.1% and 73.7% in groups A and B, respectively. IOP-lowering drugs were used to control IOP; however, one patient in each group needed glaucoma filtration surgery in both eyes after intractable glaucoma with failure of medical treatment. CONCLUSION Although intravitreal injection of triamcinolone acetonide is very effective in managing DME and with lower cost than other modalities, the rise in IOP and the burden of glaucoma are major concerns. High corticosteroid responder is an individualized reaction irrespective of the intravitreal triamcinolone acetonide dose used.",2013,"RESULTS Intravitreal triamcinolone acetonide was effective in reduction of DME in group A in the first 3 months only, while in group B with high dose (8 mg) the improvement continued for 6 months after injection.","['Nineteen patients with bilateral DME', 'diabetic macular edema (DME']","['glaucoma filtration surgery', 'triamcinolone acetonide']","['Significant IOP rise', 'reduction of DME', 'intraocular pressure (IOP']","[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0641456', 'cui_str': 'DMES'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}]","[{'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0242673', 'cui_str': 'Surgery, Filtration'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone Acetonide'}]","[{'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0641456', 'cui_str': 'DMES'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}]",19.0,0.025317,"RESULTS Intravitreal triamcinolone acetonide was effective in reduction of DME in group A in the first 3 months only, while in group B with high dose (8 mg) the improvement continued for 6 months after injection.","[{'ForeName': 'Ehab M', 'Initials': 'EM', 'LastName': 'Ghoneim', 'Affiliation': 'Ophthalmology Department, Suez Canal University Hospital, Ismailia, Egypt, ehabghoneim@hotmail.com.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Abd El Ghany', 'Affiliation': ''}]",Ophthalmology and therapy,['10.1007/s40123-013-0017-0'] 477,25156975,"A Randomized, Controlled Treatment Trial of Eyelid-Warming Therapies in Meibomian Gland Dysfunction.","AIM The main treatment for meibomian gland dysfunction (MGD), a major cause of dry eye, is eyelid warming. Lack of compliance is the main reason for treatment failure. This has led to the development of eyelid-warming devices that are safe, effective and convenient. To obtain robust evidence demonstrating their efficacy, the authors conducted a 3-arm randomized clinical study. METHODS The authors conducted a 3-month assessor-blinded, randomized, controlled trial of patients from the Singapore National Eye Centre experiencing at least one of eight dry eye symptoms 'often' or 'all the time'. Patients who wore contact lenses, had an active infection or known diagnosis of thyroid dysfunction and rheumatoid arthritis were excluded from the study. MGD participants were randomly assigned to warm towel (n = 25), EyeGiene(®) (Eyedetec Medical Inc., Danville, CA, USA) (n = 25) and Blephasteam(®) (Spectrum Thea Pharmaceuticals LTD, Macclesfield, UK) (n = 25) treatments. The primary efficacy and safety outcomes included the proportions of participants with improved symptoms and changes in best corrected visual acuity (BCVA), respectively. Other outcomes included tear break up time (TBUT), Schirmer test, corneal fluorescein dye staining and number of visibly occluded meibomian gland (MG) orifices. RESULTS The study population was 53.5 ± 11.1 years old and predominantly Chinese. For severity of symptom after 3 months of treatment, 78.3% Blephasteam(®) participants reported improvement compared to 45.5% warm towel participants (p = 0.023). The corresponding proportions for improvement in the frequency of symptoms were 82.6% and 50.0%, respectively (p = 0.020). The proportions of improvement of symptoms in EyeGiene(®) patients were not significantly different from warm towel intervention. At 1 month of treatment, the crude odds ratio of improvement of severity of irritation for Blephasteam(®) compared to control was 3.0 (95% CI 0.88-10.18). However, the odds ratio adjusted by age was 5.67 (1.30-24.66). The lid-warming treatments did not significantly change the TBUT, Schirmer test results or number of visibly occluded MGs in the study period. All treatment modalities did not worsen BCVA after 3 months. CONCLUSION Blephasteam(®) is more effective than warm towel for MGD treatment, with warm towel and EyeGiene(®) being comparable effective. Older age might predict for treatment efficacy. All studied therapies were safe for visual acuity (VA) for 3 months of treatment.",2014,"The lid-warming treatments did not significantly change the TBUT, Schirmer test results or number of visibly occluded MGs in the study period.","['Patients who wore contact lenses, had an active infection or known diagnosis of thyroid dysfunction and rheumatoid arthritis were excluded from the study', 'MGD participants', '11.1\xa0years old and predominantly Chinese', 'Meibomian Gland Dysfunction', 'The study population was 53.5\xa0±', ""patients from the Singapore National Eye Centre experiencing at least one of eight dry eye symptoms 'often' or 'all the time""]","['EyeGiene(®) (Eyedetec Medical Inc., Danville, CA, USA', 'Eyelid-Warming Therapies', 'Blephasteam(®', 'Blephasteam(®) (Spectrum Thea Pharmaceuticals LTD, Macclesfield, UK']","['crude odds ratio of improvement of severity of irritation for Blephasteam(®', 'TBUT, Schirmer test results or number of visibly occluded MGs', 'tear break up time (TBUT), Schirmer test, corneal fluorescein dye staining and number of visibly occluded meibomian gland (MG) orifices', 'frequency of symptoms', 'proportions of participants with improved symptoms and changes in best corrected visual acuity (BCVA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009836', 'cui_str': 'Contact Lenses'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C2609421', 'cui_str': 'Thyroid dysfunction (SMQ)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C1275684', 'cui_str': 'MGD-Meibomian gland dysfunction'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0314719', 'cui_str': 'Dry eyes (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0015426', 'cui_str': 'Eyelids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0543468', 'cui_str': 'Thea'}]","[{'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0441723', 'cui_str': 'Irritation (qualifier value)'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test (procedure)""}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1947917', 'cui_str': 'Occluded (qualifier value)'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0060520', 'cui_str': 'Fluorescein'}, {'cui': 'C0013343', 'cui_str': 'Dyes'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C0025181', 'cui_str': 'Tarsal Glands'}, {'cui': 'C0436350', 'cui_str': 'Symptom frequency (observable entity)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}]",,0.173783,"The lid-warming treatments did not significantly change the TBUT, Schirmer test results or number of visibly occluded MGs in the study period.","[{'ForeName': 'Hui Shan', 'Initials': 'HS', 'LastName': 'Sim', 'Affiliation': 'Duke-National University of Singapore Graduate Medical School, Singapore, Singapore.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Petznick', 'Affiliation': 'Singapore Eye Research Institute, Singapore, Singapore.'}, {'ForeName': 'Sylvaine', 'Initials': 'S', 'LastName': 'Barbier', 'Affiliation': 'Duke-National University of Singapore Graduate Medical School, Singapore, Singapore.'}, {'ForeName': 'Jen Hong', 'Initials': 'JH', 'LastName': 'Tan', 'Affiliation': 'Ngee Ann Polytechnic, Singapore, Singapore.'}, {'ForeName': 'U Rajendra', 'Initials': 'UR', 'LastName': 'Acharya', 'Affiliation': 'Ngee Ann Polytechnic, Singapore, Singapore.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Yeo', 'Affiliation': 'Singapore Eye Research Institute, Singapore, Singapore. sharon.yeo.w.j@seri.com.sg.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Tong', 'Affiliation': 'Duke-National University of Singapore Graduate Medical School, Singapore, Singapore.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology and therapy,['10.1007/s40123-014-0025-8'] 478,25135387,"Systemic ropivacaine diminishes pain sensitization processes: a randomized, double-blinded, placebo-controlled, crossover study in healthy volunteers.","INTRODUCTION Ropivacaine is a local anesthetic widely used for regional anesthesia. One of its advantages is low toxicity at plasma concentrations reached systemically during continuous peripheral or central nervous block. The objective of this study was to test the effect of systemic ropivacaine on pain, hyperalgesia, dynamic allodynia, and flare response. METHODS This randomized, double-blinded, placebo-controlled, crossover study was carried out in at the Clinical Trials Centre, University of Zurich, Switzerland. Twenty healthy male volunteers were included in the study. Exclusion criteria were contraindications or hypersensitivity to local anesthetics, vulnerable subjects (intellectually or mental impaired), drug, alcohol or nicotine abuse, known peripheral neuropathies, diabetes mellitus and/or congestive heart disease. Ropivacaine and saline were infused intravenously during a subcutaneous electrical stimulation. The stimulation software adjusted the stimulus strength according to the rating on a numeric rating scale (NRS; 0-10) maintaining a NRS of 5. Areas of punctate hyperalgesia, dynamic allodynia, and flare response were measured before and after the infusion. RESULTS The area of hyperalgesia increased significantly with saline (303 ± 380%, P < 0.05) and ropivacaine (186 ± 137%, P < 0.05). The area of allodynia (253 ± 299%, P < 0.05) and flare response (112 ± 24%, P < 0.05) increased only during the placebo infusion. CONCLUSION The results of this study imply that systemic ropivacaine may diminish pain sensitization processes.",2014,"The area of hyperalgesia increased significantly with saline (303 ± 380%, P < 0.05) and ropivacaine (186 ± 137%, P ","['Exclusion criteria were contraindications or hypersensitivity to local anesthetics, vulnerable subjects (intellectually or mental impaired), drug, alcohol or nicotine abuse, known peripheral neuropathies, diabetes mellitus and/or congestive heart disease', 'Twenty healthy male volunteers', 'at the Clinical Trials Centre, University of Zurich, Switzerland', 'healthy volunteers']","['placebo', 'Systemic ropivacaine', 'systemic ropivacaine', 'ropivacaine', 'Ropivacaine', 'Ropivacaine and saline']","['pain sensitization processes', 'pain, hyperalgesia, dynamic allodynia, and flare response', 'area of hyperalgesia', 'area of allodynia', 'punctate hyperalgesia, dynamic allodynia, and flare response', 'flare response']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1301624', 'cui_str': 'Contraindications'}, {'cui': 'C3544362', 'cui_str': 'Hypersensitivity (SMQ)'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C2363943', 'cui_str': 'Nicotine abuse'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure (disorder)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3838777', 'cui_str': 'Sensitization process (qualifier value)'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesic Sensations'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0458247', 'cui_str': 'Allodynia'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205330', 'cui_str': 'Punctate (qualifier value)'}]",20.0,0.400809,"The area of hyperalgesia increased significantly with saline (303 ± 380%, P < 0.05) and ropivacaine (186 ± 137%, P ","[{'ForeName': 'Yéri', 'Initials': 'Y', 'LastName': 'Haller', 'Affiliation': 'Institute of Anaesthesiology, University Hospital of Zurich, Raemistrasse 100, 8091, Zurich, Switzerland.'}, {'ForeName': 'Andreas R', 'Initials': 'AR', 'LastName': 'Gantenbein', 'Affiliation': ''}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Willimann', 'Affiliation': ''}, {'ForeName': 'Donat R', 'Initials': 'DR', 'LastName': 'Spahn', 'Affiliation': ''}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Maurer', 'Affiliation': ''}]",Pain and therapy,['10.1007/s40122-013-0021-z'] 479,31290754,"Optimal dilation time for combined small endoscopic sphincterotomy and balloon dilation for common bile duct stones: A multicentre, single-blinded, randomised controlled trial.",,2019,,['common bile duct stones'],['small endoscopic sphincterotomy and balloon dilation'],[],"[{'cui': 'C0009438', 'cui_str': 'Common Bile Duct Gall Stones'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0085263', 'cui_str': 'Endoscopic Biliary Sphincterotomy'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}]",[],,0.358043,,"[{'ForeName': 'A Emre', 'Initials': 'AE', 'LastName': 'Yıldırım', 'Affiliation': 'Department of Gastroenterology, Gaziantep University School of Medicine, Gaziantep, Turkey.'}]",The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology,['10.5152/tjg.2019.240519'] 480,31921719,The Effect of Initial High vs. Low FiO 2 on Breathing Effort in Preterm Infants at Birth: A Randomized Controlled Trial.,"Background: Infants are currently stabilized at birth with initial low FiO 2 which increases the risk of hypoxia and suppression of breathing in the first minutes after birth. We hypothesized that initiating stabilization at birth with a high O 2 concentration, followed by titration, would improve breathing effort when compared to a low O 2 concentration, followed by titration. Methods: In a bi-center randomized controlled trial, infants <30 weeks gestation were stabilized at birth with an initial O 2 concentration of 30 or 100%, followed by oxygen titration. Primary outcome was minute volume of spontaneous breathing. We also assessed tidal volumes, mean inspiratory flow rate (MIFR) and respiratory rate with a respiratory function monitor in the first 5 min after birth, and evaluated the duration of mask ventilation in the first 10 min after birth. Pulse oximetry was used to measure heart rate and SpO 2 values in the first 10 min. Hypoxemia was defined as SpO 2 < 25th percentile and hyperoxemia as SpO 2 >95%. 8-iso-prostaglandin F2α (8iPGF2α) was measured to assess oxidative stress in cord blood and 1 and 24 h after birth. Results: Fifty-two infants were randomized and recordings were obtained in 44 infants (100% O 2 -group: n = 20, 30% O 2 -group: n = 24). Minute volumes were significantly higher in the 100% O 2 -group (146.34 ± 112.68 mL/kg/min) compared to the 30% O 2 -group (74.43 ± 52.19 mL/kg/min), p = 0.014. Tidal volumes and MIFR were significantly higher in the 100% O 2 -group, while the duration of mask ventilation given was significantly shorter. Oxygenation in the first 5 min after birth was significantly higher in infants in the 100% O 2 -group [85 (64-93)%] compared to the 30% O 2 -group [58 (46-67)%], p < 0.001. The duration of hypoxemia was significantly shorter in the 100% O 2 -group, while the duration of hyperoxemia was not different between groups. There was no difference in oxidative stress marker 8iPGF2α between the groups. Conclusion: Initiating stabilization of preterm infants at birth with 100% O 2 led to higher breathing effort, improved oxygenation, and a shorter duration of mask ventilation as compared to 30% O 2 , without increasing the risk for hyperoxia or oxidative stress. Clinical Trial Registration: This study was registered in www.trialregister.nl, with registration number NTR6878.",2019,"Tidal volumes and MIFR were significantly higher in the 100% O 2 -group, while the duration of mask ventilation given was significantly shorter.","['Preterm Infants at Birth', 'Results: Fifty-two infants']","['8-iso-prostaglandin F2α (8iPGF2α', 'Initial High vs. Low FiO 2']","['Oxygenation', 'oxidative stress marker 8iPGF2α', 'minute volume of spontaneous breathing', 'Hypoxemia', 'tidal volumes, mean inspiratory flow rate (MIFR) and respiratory rate with a respiratory function monitor', 'heart rate and SpO 2 values', 'higher breathing effort, improved oxygenation, and a shorter duration of mask ventilation', 'Minute volumes', 'duration of hyperoxemia', 'risk of hypoxia and suppression of breathing', 'duration of mask ventilation', 'Tidal volumes and MIFR', 'duration of hypoxemia', 'oxidative stress']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0911936', 'cui_str': 'iso(VL)'}, {'cui': 'C0356622', 'cui_str': 'Prostaglandins, oxytocics'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0428679', 'cui_str': 'Minute volume (observable entity)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0040210', 'cui_str': 'Tidal Volume'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}]",52.0,0.182462,"Tidal volumes and MIFR were significantly higher in the 100% O 2 -group, while the duration of mask ventilation given was significantly shorter.","[{'ForeName': 'Janneke', 'Initials': 'J', 'LastName': 'Dekker', 'Affiliation': 'Department of Neonatology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Martherus', 'Affiliation': 'Department of Neonatology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Lopriore', 'Affiliation': 'Department of Neonatology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Giera', 'Affiliation': 'Center Proteomics Metabolomics, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Erin V', 'Initials': 'EV', 'LastName': 'McGillick', 'Affiliation': 'The Ritchie Centre, Hudson Institute for Medical Research, Melbourne, VIC, Australia.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Hutten', 'Affiliation': ""Department of Neonatology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.""}, {'ForeName': 'Ruud W', 'Initials': 'RW', 'LastName': 'van Leuteren', 'Affiliation': ""Department of Neonatology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.""}, {'ForeName': 'Anton H', 'Initials': 'AH', 'LastName': 'van Kaam', 'Affiliation': ""Department of Neonatology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.""}, {'ForeName': 'Stuart B', 'Initials': 'SB', 'LastName': 'Hooper', 'Affiliation': 'The Ritchie Centre, Hudson Institute for Medical Research, Melbourne, VIC, Australia.'}, {'ForeName': 'Arjan B', 'Initials': 'AB', 'LastName': 'Te Pas', 'Affiliation': 'Department of Neonatology, Leiden University Medical Center, Leiden, Netherlands.'}]",Frontiers in pediatrics,['10.3389/fped.2019.00504'] 481,25135699,"Transcorneal electrical stimulation in patients with retinal artery occlusion: a prospective, randomized, sham-controlled pilot study.","INTRODUCTION The purpose of this study was to investigate the safety and efficacy of transcorneal electrical stimulation (TES) in patients suffering from retinal artery occlusion (RAO). METHODS Twelve patients with central and one patient with branch RAO (age 25-84 years, median 74 years) were enrolled in this prospective, randomized, sham-controlled study. RAO was diagnosed 10 days to 17 months prior to study participation. Patients were treated with TES (5 ms positive followed by 5 ms negative biphasic pulses at 20 Hz; applied with DTL electrodes) for 30 min once a week for 6 consecutive weeks. Patients were randomly assigned to TES with 0 mA (sham, n = 3), 66% (n = 5) or 150% (n = 5) of the patient's individual electrical phosphene threshold (EPT) at 20 Hz. Best corrected visual acuity, ophthalmology examination and EPT (at 3, 6, 9, 20, 40, 60, and 80 Hz) were determined at baseline and at eight follow-up visits over 17 weeks. During four visits (week 1, 5, 9, and 17) kinetic and static visual fields as well as full-field and multifocal electroretinography were measured. The method of restricted maximum likelihood (P < 0.05, Tukey-Kramer) was used to estimate the development of parameters under treatment. RESULTS TES was tolerated well; no ocular or systemic adverse events were observed except for foreign-body sensation after TES (n = 3). During the study period the slopes of the scotopic a-wave increased significantly (high-intensity flash white 10 cd.s/m(2); P = 0.03) in the 150% treatment group. All other parameters in all other groups remained statistically unchanged. CONCLUSIONS Although TES was tolerated well, statistically significant improvements were found only for specific a-wave slopes. This is in contradiction to previous smaller, uncontrolled reports. Further studies with larger sample sizes and longer duration might, however, show additional significant effects.",2013,"RESULTS TES was tolerated well; no ocular or systemic adverse events were observed except for foreign-body sensation after TES (n = 3).","['patients suffering from retinal artery occlusion (RAO', 'patients with retinal artery occlusion', 'Twelve patients with central and one patient with branch RAO', 'age 25-84\xa0years, median 74\xa0years']","['TES with 0\xa0mA', 'transcorneal electrical stimulation (TES', 'TES (5\xa0ms positive followed by 5\xa0ms negative biphasic pulses at 20\xa0Hz; applied with DTL electrodes', 'TES', ""patient's individual electrical phosphene threshold (EPT"", 'Transcorneal electrical stimulation']","['tolerated well; no ocular or systemic adverse events', 'safety and efficacy', 'Best corrected visual acuity, ophthalmology examination and EPT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035302', 'cui_str': 'Retinal Artery Occlusion'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205384', 'cui_str': 'Branching (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]","[{'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0205184', 'cui_str': 'Biphasic (qualifier value)'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0013812', 'cui_str': 'Electrode, device (physical object)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C0031624', 'cui_str': 'Phosphenes'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0039512', 'cui_str': 'Teniposide'}]","[{'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0039512', 'cui_str': 'Teniposide'}]",12.0,0.0394069,"RESULTS TES was tolerated well; no ocular or systemic adverse events were observed except for foreign-body sensation after TES (n = 3).","[{'ForeName': 'Lubka', 'Initials': 'L', 'LastName': 'Naycheva', 'Affiliation': 'Centre for Ophthalmology, Schleichstr. 12-16, 72076, Tübingen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schatz', 'Affiliation': ''}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Willmann', 'Affiliation': ''}, {'ForeName': 'Karl Ulrich', 'Initials': 'KU', 'LastName': 'Bartz-Schmidt', 'Affiliation': ''}, {'ForeName': 'Eberhart', 'Initials': 'E', 'LastName': 'Zrenner', 'Affiliation': ''}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Röck', 'Affiliation': ''}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Gekeler', 'Affiliation': ''}]",Ophthalmology and therapy,['10.1007/s40123-013-0012-5'] 482,25135037,Effects of a single session group intervention for pain management in chronic pain patients: a pilot study.,"INTRODUCTION Behavioral and psychological interventions are key components of treating chronic pain. However, there are logistical barriers to providing such treatments, including a lack of psychological staff to provide such interventions and limited ability of patients with chronic pain to attend multiple sessions. As other areas of mental health have shown promise in providing single session interventions for various conditions, this pilot study hypothesized that a single group session for chronic pain patients could be helpful in decreasing patient pain catastrophizing. The five content areas addressed in the group were termed understanding, accepting, calming, balancing, and coping. METHODS A pilot study was undertaken. Chronic pain patients were given a pre-group assessment, including the Pain Catastrophizing Scale with a follow-up assessment administered 3 months later. RESULTS Fifty-three patients were studied. Results showed a significant decrease in overall pain catastrophizing scores at follow-up. A clear majority of patients also reported that the group was helpful and should be offered to other pain patients. CONCLUSION This study suggests that a single session group can be a helpful intervention for patients with chronic pain.",2013,Results showed a significant decrease in overall pain catastrophizing scores at follow-up.,"['Chronic pain patients', 'patients with chronic pain', 'chronic pain patients', 'Fifty-three patients were studied']",['single session group intervention'],"['overall pain catastrophizing scores', 'Pain Catastrophizing Scale']","[{'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}]",53.0,0.0419082,Results showed a significant decrease in overall pain catastrophizing scores at follow-up.,"[{'ForeName': 'Ted', 'Initials': 'T', 'LastName': 'Jones', 'Affiliation': 'Behavioral Medicine Institute, Pain Consultants of East Tennessee, 1128 E. Weisgarber Road, Suite 100, Knoxville, TN, 37909, USA, tjones@painconsultants.com.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Lookatch', 'Affiliation': ''}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Moore', 'Affiliation': ''}]",Pain and therapy,['10.1007/s40122-013-0012-0'] 483,25135823,Treatment of Asymptomatic Carriers of Plasmodium falciparum with Artemether-Lumefantrine: Impact on the Prevalence of Anemia.,"INTRODUCTION An investigation of whether treatment of asymptomatic carriers of Plasmodium falciparum with artemether-lumefantrine (AL), in addition to the routine treatment of symptomatic cases with AL, could improve the prevalence of anemia in 18 villages in Burkina Faso. METHODS This was a single-center, controlled, parallel, cluster-randomized study to evaluate the effect of systematic treatment of P. falciparum asymptomatic carriers at a community level on hemoglobin (Hb) levels and anemic status of children (<5 years) and adults during four screening campaigns carried out over a 12-month period, compared with no treatment of asymptomatic carriers. RESULTS The change in Hb level in all asymptomatic carriers aged >6 months from Day 1 to Day 28 of the first campaign was +0.53 g/dl (from 11.81 to 12.33 g/dl) in the intervention arm vs. -0.21 g/dl (from 12.06 to 11.86 g/dl) in the control arm (P < 0.001). During the same period, the proportion of asymptomatic carriers aged >6 months to <5 years with anemia in the intervention arm decreased by 31.1% (from 75.7% to 44.6%), compared with a decrease of 4.7% (from 76.3% to 71.6%) in the control arm. Over 12 months, the proportion of asymptomatic carriers with anemia (mild, moderate, or severe) was reduced in both arms. CONCLUSION Systematic screening and treatment of asymptomatic carriers of P. falciparum with AL at the community level can reduce the prevalence of anemia in children in the short term (28 days), although the effect was not maintained at 12 months.",2013,"Systematic screening and treatment of asymptomatic carriers of P. falciparum with AL at the community level can reduce the prevalence of anemia in children in the short term (28 days), although the effect was not maintained at 12 months.","['Asymptomatic Carriers of Plasmodium falciparum with Artemether-Lumefantrine', 'asymptomatic carriers of Plasmodium falciparum with artemether', '18 villages in Burkina Faso', 'P. falciparum asymptomatic carriers at a community level on hemoglobin (Hb) levels and anemic status of children (<5\xa0years) and adults during four screening campaigns carried out over a 12-month period, compared with no treatment of asymptomatic carriers']",['lumefantrine (AL'],"['proportion of asymptomatic carriers with anemia (mild, moderate, or severe', 'change in Hb level', 'Prevalence of Anemia']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0560175', 'cui_str': 'Carrier State'}, {'cui': 'C0032150', 'cui_str': 'Plasmodium falciparum'}, {'cui': 'C0936150', 'cui_str': 'artemether / lumefantrine'}, {'cui': 'C0052429', 'cui_str': 'artemether'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0006409', 'cui_str': 'Upper Volta'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0531104', 'cui_str': 'lumefantrine'}]","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0560175', 'cui_str': 'Carrier State'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",,0.0688485,"Systematic screening and treatment of asymptomatic carriers of P. falciparum with AL at the community level can reduce the prevalence of anemia in children in the short term (28 days), although the effect was not maintained at 12 months.","[{'ForeName': 'Alfred B', 'Initials': 'AB', 'LastName': 'Tiono', 'Affiliation': 'Centre National de Recherche et de Formation sur le Paludisme, Ministère de la Santé, O1BP 2208, Ouagadougou, Burkina Faso, t.alfred@fasonet.bf.'}, {'ForeName': 'Alphonse', 'Initials': 'A', 'LastName': 'Ouédraogo', 'Affiliation': ''}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Remy', 'Affiliation': ''}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Hamed', 'Affiliation': ''}]",Infectious diseases and therapy,['10.1007/s40121-013-0005-7'] 484,25135585,Topical isopropyl unoprostone for retinitis pigmentosa: microperimetric results of the phase 2 clinical study.,"INTRODUCTION The purpose of this study was to determine whether topical 0.15% isopropyl unoprostone (IU), a BK-channel activator, could improve or maintain the central retinal sensitivity in patients with middle- to late-stage retinitis pigmentosa (RP). IU was approved for glaucoma and ocular hypertension in 1994. The drug re-profiling strategy is one of the effective ways to develop safe drugs for patients with RP. METHODS A randomized, double-blind, and placebo-controlled phase II safety/efficacy trial was conducted. One hundred and nine patients with middle- to late-stage RP having a visual acuity of ≥0.5 were studied at six ophthalmological centers in Japan. The treatments of IU/day were divided into three groups: placebo group; two-drop group; and four-drop group for 24 weeks. The primary outcome measure was changes in the retinal sensitivity from baseline in the central 2° determined by MP-1 microperimetry (MP-1, Nidek, Japan). The secondary outcomes were changes in best-correct visual acuity, contrast sensitivity, retinal sensitivity of the central 10° by MP-1, mean deviation (MD) by a Humphrey field analyzer (HFA; Carl Zeiss Meditec, Dublin, CA, USA) 10-2, and the Visual Functioning Questionnaire 25 (VFQ-25) questionnaire scores. RESULTS There was a tendency for a dose-dependent responsiveness in retinal sensitivity in the central 2°, MD, and total VFQ-25 score after 24 weeks of IU instillation by a simple linear regression analysis. A stratified analysis showed a significant dose-dependent responsiveness of the 2° central retinal sensitivity in more advanced patients (P = 0.028). The number of patients having a ≥4 dB decrease in the primary outcome measure was significantly fewer in the four-drop group than in the placebo group (P = 0.02). No adverse reactions were observed. CONCLUSIONS A higher dose of IU can delay progression of the central retinal sensitivity decrease through an improvement of retinal sensitivity.",2012,"There was a tendency for a dose-dependent responsiveness in retinal sensitivity in the central 2°, MD, and total VFQ-25 score after 24 weeks of IU instillation by a simple linear regression analysis.","['One hundred and nine patients with middle- to late-stage RP having a visual acuity of ≥0.5 were studied at six ophthalmological centers in Japan', 'patients with middle- to late-stage retinitis pigmentosa (RP', 'patients with RP', 'retinitis pigmentosa']","['Topical isopropyl unoprostone', 'placebo', 'topical 0.15% isopropyl unoprostone (IU), a BK-channel activator']","['central retinal sensitivity', 'adverse reactions', 'retinal sensitivity from baseline in the central 2° determined by MP-1 microperimetry (MP-1, Nidek, Japan', 'changes in best-correct visual acuity, contrast sensitivity, retinal sensitivity of the central 10° by MP-1, mean deviation (MD) by a Humphrey field analyzer (HFA; Carl Zeiss Meditec, Dublin, CA, USA) 10-2, and the Visual Functioning Questionnaire 25 (VFQ-25) questionnaire scores', 'total VFQ-25 score', 'retinal sensitivity']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C1279941', 'cui_str': 'Late stage (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2013096', 'cui_str': 'OPHTHALMOLOGICALS'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0035334', 'cui_str': 'Pigmentary Retinopathy'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0527038', 'cui_str': 'isopropyl unoprostone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4068886', 'cui_str': '0.15 (qualifier value)'}, {'cui': 'C0288250', 'cui_str': 'Large-Conductance Calcium-Activated Potassium Channels'}]","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity (observable entity)'}, {'cui': 'C0009928', 'cui_str': 'Visual Contrast Sensitivity'}, {'cui': 'C1828170', 'cui_str': 'Visual field index - mean deviation (observable entity)'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0179038', 'cui_str': 'Analyzer'}, {'cui': 'C0454777', 'cui_str': 'Dublin (geographic location)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",109.0,0.400602,"There was a tendency for a dose-dependent responsiveness in retinal sensitivity in the central 2°, MD, and total VFQ-25 score after 24 weeks of IU instillation by a simple linear regression analysis.","[{'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Ophthalmology and Visual Science, Chiba University Graduate School of Medicine, Chiba, Japan, shuyama@faculty.chiba-u.jp.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Sugawara', 'Affiliation': ''}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Murakami', 'Affiliation': ''}, {'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Nakazawa', 'Affiliation': ''}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Nao-I', 'Affiliation': ''}, {'ForeName': 'Shigeki', 'Initials': 'S', 'LastName': 'Machida', 'Affiliation': ''}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Wada', 'Affiliation': ''}, {'ForeName': 'Yukihiko', 'Initials': 'Y', 'LastName': 'Mashima', 'Affiliation': ''}, {'ForeName': 'Yozo', 'Initials': 'Y', 'LastName': 'Myake', 'Affiliation': ''}]",Ophthalmology and therapy,['10.1007/s40123-012-0005-9'] 485,24158787,Everolimus plus exemestane in postmenopausal patients with HR(+) breast cancer: BOLERO-2 final progression-free survival analysis.,"INTRODUCTION Effective treatments for hormone-receptor-positive (HR(+)) breast cancer (BC) following relapse/progression on nonsteroidal aromatase inhibitor (NSAI) therapy are needed. Initial Breast Cancer Trials of OraL EveROlimus-2 (BOLERO-2) trial data demonstrated that everolimus and exemestane significantly prolonged progression-free survival (PFS) versus placebo plus exemestane alone in this patient population. METHODS BOLERO-2 is a phase 3, double-blind, randomized, international trial comparing everolimus (10 mg/day) plus exemestane (25 mg/day) versus placebo plus exemestane in postmenopausal women with HR(+) advanced BC with recurrence/progression during or after NSAIs. The primary endpoint was PFS by local investigator review, and was confirmed by independent central radiology review. Overall survival, response rate, and clinical benefit rate were secondary endpoints. RESULTS Final study results with median 18-month follow-up show that median PFS remained significantly longer with everolimus plus exemestane versus placebo plus exemestane [investigator review: 7.8 versus 3.2 months, respectively; hazard ratio = 0.45 (95% confidence interval 0.38-0.54); log-rank P < 0.0001; central review: 11.0 versus 4.1 months, respectively; hazard ratio = 0.38 (95% confidence interval 0.31-0.48); log-rank P < 0.0001] in the overall population and in all prospectively defined subgroups, including patients with visceral metastases, [corrected] and irrespective of age. The incidence and severity of adverse events were consistent with those reported at the interim analysis and in other everolimus trials. CONCLUSION The addition of everolimus to exemestane markedly prolonged PFS in patients with HR(+) advanced BC with disease recurrence/progression following prior NSAIs. These results further support the use of everolimus plus exemestane in this patient population. ClinicalTrials.gov #NCT00863655.",2013,"RESULTS Final study results with median 18-month follow-up show that median PFS remained significantly longer with everolimus plus exemestane versus placebo plus exemestane [investigator review: 7.8 versus 3.2 months, respectively; hazard ratio = 0.45 (95% confidence interval 0.38-0.54); log-rank P < 0.0001; central review: 11.0 versus 4.1 months, respectively; hazard ratio = 0.38 (95% confidence interval 0.31-0.48); log-rank P < 0.0001] in the overall population and in all prospectively defined subgroups, including patients with visceral metastases, [corrected] and irrespective of age.","['patients with HR(+) advanced BC with disease recurrence/progression following prior NSAIs', 'hormone-receptor-positive (HR', 'Initial Breast Cancer Trials of OraL', 'postmenopausal patients with HR(+) breast cancer', 'postmenopausal women with HR(+) advanced BC with recurrence/progression during or after NSAIs']","['Everolimus plus exemestane', 'everolimus', 'nonsteroidal aromatase inhibitor (NSAI) therapy', 'placebo plus exemestane', 'everolimus plus exemestane', 'exemestane', 'everolimus and exemestane']","['median PFS', 'Overall survival, response rate, and clinical benefit rate', 'incidence and severity of adverse events', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.638382,"RESULTS Final study results with median 18-month follow-up show that median PFS remained significantly longer with everolimus plus exemestane versus placebo plus exemestane [investigator review: 7.8 versus 3.2 months, respectively; hazard ratio = 0.45 (95% confidence interval 0.38-0.54); log-rank P < 0.0001; central review: 11.0 versus 4.1 months, respectively; hazard ratio = 0.38 (95% confidence interval 0.31-0.48); log-rank P < 0.0001] in the overall population and in all prospectively defined subgroups, including patients with visceral metastases, [corrected] and irrespective of age.","[{'ForeName': 'Denise A', 'Initials': 'DA', 'LastName': 'Yardley', 'Affiliation': 'Sarah Cannon Research Institute and Tennessee Oncology, PLLC, Nashville, TN, 37203, USA, dyardley@tnonc.com.'}, {'ForeName': 'Shinzaburo', 'Initials': 'S', 'LastName': 'Noguchi', 'Affiliation': ''}, {'ForeName': 'Kathleen I', 'Initials': 'KI', 'LastName': 'Pritchard', 'Affiliation': ''}, {'ForeName': 'Howard A', 'Initials': 'HA', 'LastName': 'Burris', 'Affiliation': ''}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Baselga', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gnant', 'Affiliation': ''}, {'ForeName': 'Gabriel N', 'Initials': 'GN', 'LastName': 'Hortobagyi', 'Affiliation': ''}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Campone', 'Affiliation': ''}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Pistilli', 'Affiliation': ''}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Piccart', 'Affiliation': ''}, {'ForeName': 'Bohuslav', 'Initials': 'B', 'LastName': 'Melichar', 'Affiliation': ''}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Petrakova', 'Affiliation': ''}, {'ForeName': 'Francis P', 'Initials': 'FP', 'LastName': 'Arena', 'Affiliation': ''}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Erdkamp', 'Affiliation': ''}, {'ForeName': 'Wael A', 'Initials': 'WA', 'LastName': 'Harb', 'Affiliation': ''}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Feng', 'Affiliation': ''}, {'ForeName': 'Ayelet', 'Initials': 'A', 'LastName': 'Cahana', 'Affiliation': ''}, {'ForeName': 'Tetiana', 'Initials': 'T', 'LastName': 'Taran', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lebwohl', 'Affiliation': ''}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': ''}]",Advances in therapy,['10.1007/s12325-013-0060-1'] 486,24477670,Type 2 diabetes mellitus management and body mass index: experiences with initiating insulin detemir in the a1chieve study.,"INTRODUCTION This sub-analysis of the A1chieve study aimed to examine the safety and efficacy of insulin detemir (IDet) initiation over 24 weeks in relation to baseline body mass index (BMI) in people with type 2 diabetes mellitus (T2DM). METHODS A1chieve was a 24-week non-interventional study to assess the safety and efficacy of insulin analogs in routine practice. This sub-analysis included insulin-naïve patients who initiated IDet therapy based on their physicians' decision. Patients were stratified according to baseline BMI (Group I, <25.0 kg/m(2); Group II, 25.0 to <30.0 kg/m(2); Group III, 30.0 to <35.0 kg/m(2); Group IV ≥35.0 kg/m(2)). Safety and efficacy variables were assessed over 24 weeks. RESULTS Overall, 10,650 insulin-naïve patients were included (3,045 patients in Group I, 4,186 patients in Group II, 2,365 patients in Group III, and 1,054 patients in Group IV). Four serious adverse drug reactions (SADRs) were reported. From baseline to Week 24, there was no statistically significant difference in the proportion of patients reporting overall hypoglycemia in Group I (4.0% vs. 4.4%), while a significant decrease in Group II (4.8% vs. 4.0%, p = 0.0335) and significant increases in Groups III and IV (3.3% vs. 5.4% and 3.4% vs. 7.0%, respectively, p < 0.001) were noted. The mean body weight increased from baseline to Week 24 in Group I (60.7 ± 8.4 vs. 61.8 ± 8.5 kg) and reduced in Groups II, III, and IV (74.5 ± 9.2 vs. 74.2 ± 9.2 kg, 87.4 ± 10.3 vs. 86.0 ± 9.8 kg, and 102.2 ± 14.3 vs. 100.1 ± 14.2 kg, respectively; all p < 0.001). Significant improvements were noted in glycemic parameters, systolic blood pressure, and lipids over 24 weeks, irrespective of baseline BMI status. CONCLUSION IDet therapy was associated with improved glycemic control and a low number of SADRs. Greater weight loss was observed with higher BMI.",2014,"From baseline to Week 24, there was no statistically significant difference in the proportion of patients reporting overall hypoglycemia in Group I (4.0% vs. 4.4%), while a significant decrease in Group II (4.8% vs. 4.0%, p = 0.0335) and significant increases in Groups III and IV (3.3% vs. 5.4% and 3.4% vs. 7.0%, respectively, p < 0.001) were noted.","[""insulin-naïve patients who initiated IDet therapy based on their physicians' decision"", 'people with type 2 diabetes mellitus (T2DM']","['insulin analogs', 'detemir', 'insulin detemir', 'insulin']","['Safety and efficacy variables', 'Four serious adverse drug reactions (SADRs', 'safety and efficacy', 'proportion of patients reporting overall hypoglycemia', 'glycemic control and a low number of SADRs', 'Greater weight loss', 'glycemic parameters, systolic blood pressure, and lipids over 24\xa0weeks, irrespective of baseline BMI status', 'mean body weight']","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0537270', 'cui_str': 'insulin detemir'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",10650.0,0.043663,"From baseline to Week 24, there was no statistically significant difference in the proportion of patients reporting overall hypoglycemia in Group I (4.0% vs. 4.4%), while a significant decrease in Group II (4.8% vs. 4.0%, p = 0.0335) and significant increases in Groups III and IV (3.3% vs. 5.4% and 3.4% vs. 7.0%, respectively, p < 0.001) were noted.","[{'ForeName': 'Mohammed E', 'Initials': 'ME', 'LastName': 'Khamseh', 'Affiliation': 'Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences, Tehran, Iran, khamseh.m@iums.ac.ir.'}, {'ForeName': 'Vinay', 'Initials': 'V', 'LastName': 'Prusty', 'Affiliation': ''}, {'ForeName': 'Zafar', 'Initials': 'Z', 'LastName': 'Latif', 'Affiliation': ''}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Gonzalez-Galvez', 'Affiliation': ''}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Dieuzeide', 'Affiliation': ''}, {'ForeName': 'Alexey', 'Initials': 'A', 'LastName': 'Zilov', 'Affiliation': ''}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-014-0054-2'] 487,24962057,The efficacy of combined herbal extracts gel preparation in the prevention of postsurgical hypertrophic scar formation.,"INTRODUCTION The objective of preventing surgical scar formation is to improve the quality of life for patients. Many medical products have been used in preventing hypertrophic scarring but an optimal treatment method has not been established yet. At the present, there are several studies demonstrating the potential of herbs in scar prevention. The purpose of this study was to evaluate the efficacy of combined herbal extracts gel (CHG) in the prevention of surgical scar formation. METHODS All the patients who underwent bilaterally symmetric surgical procedures were selected using inclusion and exclusion criteria and were then treated with both the CHG (CHG group) and placebo gel. Each gel was applied on separate scars twice daily for 12 weeks. The scars were photographed and evaluated using Patient and Observer Scar Assessment Scale (PSAS and OSAS, respectively). RESULTS The CHG-treated scars showed lower median PSAS scores than the placebo group in color, stiffness, thickness, irregularity, and overall scores, with statistically significant difference at 12 weeks. For OSAS, the scars in the CHG group showed lower median scores than the placebo group in pigmentation, thickness, and overall scores at 12 weeks. The median OSAS scores in vascularity, relief, and pliability differed from placebo group and were statistically significant at 8 weeks. No side effects were observed in either group. CONCLUSION The CHG might be effective in the prevention of surgical scarring.",2014,"For OSAS, the scars in the CHG group showed lower median scores than the placebo group in pigmentation, thickness, and overall scores at 12 weeks.","['patients who underwent bilaterally symmetric surgical procedures', 'patients']","['CHG', 'CHG (CHG group) and placebo gel', 'placebo', 'combined herbal extracts gel (CHG', 'combined herbal extracts gel preparation']","['quality of life', 'postsurgical hypertrophic scar formation', 'median scores', 'side effects', 'color, stiffness, thickness, irregularity, and overall scores', 'Patient and Observer Scar Assessment Scale (PSAS and OSAS, respectively', 'median OSAS scores in vascularity, relief, and pliability', 'median PSAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C1527601', 'cui_str': '(alphaMe)Chg'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0376667', 'cui_str': 'Herbal'}]","[{'cui': 'C0034380'}, {'cui': 'C0162810', 'cui_str': 'Scars, Hypertrophic'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",,0.0321369,"For OSAS, the scars in the CHG group showed lower median scores than the placebo group in pigmentation, thickness, and overall scores at 12 weeks.","[{'ForeName': 'Apirag', 'Initials': 'A', 'LastName': 'Chuangsuwanich', 'Affiliation': 'Division of Plastic Surgery, Department of Surgery, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, 10700, Thailand, apirag@gmail.com.'}, {'ForeName': 'Krit', 'Initials': 'K', 'LastName': 'Jongjamfa', 'Affiliation': ''}]",Dermatology and therapy,['10.1007/s13555-014-0055-0'] 488,24232442,"Differential, but not opponent, effects of L -DOPA and citalopram on action learning with reward and punishment.","RATIONALE Decision-making involves two fundamental axes of control namely valence, spanning reward and punishment, and action, spanning invigoration and inhibition. We recently exploited a go/no-go task whose contingencies explicitly decouple valence and action to show that these axes are inextricably coupled during learning. This results in a disadvantage in learning to go to avoid punishment and in learning to no-go to obtain a reward. The neuromodulators dopamine and serotonin are likely to play a role in these asymmetries: Dopamine signals anticipation of future rewards and is also involved in an invigoration of motor responses leading to reward, but it also arbitrates between different forms of control. Conversely, serotonin is implicated in motor inhibition and punishment processing. OBJECTIVE To investigate the role of dopamine and serotonin in the interaction between action and valence during learning.Methods We combined computational modeling with pharmacological manipulation in 90 healthy human volunteers, using levodopa and citalopram to affect dopamine and serotonin, respectively. RESULTS We found that, after administration of levodopa,action learning was less affected by outcome valence when compared with the placebo and citalopram groups. This highlights in this context a predominant effect of levodopa in controlling the balance between different forms of control.Citalopram had distinct effects, increasing participants'tendency to perform active responses independent of outcome valence, consistent with a role in decreasing motor inhibition. CONCLUSIONS Our findings highlight the rich complexities of the roles played by dopamine and serotonin during instrumental learning.",2014,"We found that, after administration of levodopa,action learning was less affected by outcome valence when compared with the placebo and citalopram groups.",['90 healthy human volunteers'],"['Citalopram', 'placebo', 'levodopa and citalopram', 'dopamine and serotonin', 'citalopram', 'levodopa', 'L -DOPA and citalopram']",['action learning with reward and punishment'],"[{'cui': 'C0020155', 'cui_str': 'Human Volunteers'}]","[{'cui': 'C0008845', 'cui_str': 'Citalopram'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}]","[{'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0034119', 'cui_str': 'Punishment'}]",90.0,0.0169462,"We found that, after administration of levodopa,action learning was less affected by outcome valence when compared with the placebo and citalopram groups.","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Guitart-Masip', 'Affiliation': ''}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Economides', 'Affiliation': ''}, {'ForeName': 'Quentin J M', 'Initials': 'QJ', 'LastName': 'Huys', 'Affiliation': ''}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Frank', 'Affiliation': ''}, {'ForeName': 'Rumana', 'Initials': 'R', 'LastName': 'Chowdhury', 'Affiliation': ''}, {'ForeName': 'Emrah', 'Initials': 'E', 'LastName': 'Duzel', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dayan', 'Affiliation': ''}, {'ForeName': 'Raymond J', 'Initials': 'RJ', 'LastName': 'Dolan', 'Affiliation': ''}]",Psychopharmacology,[] 489,24888255,Distinct Prandial and Basal Glucose-Lowering Effects of Insulin Degludec/Insulin Aspart (IDegAsp) at Steady State in Subjects with Type 1 Diabetes Mellitus.,"INTRODUCTION/AIM Insulin degludec/insulin aspart (IDegAsp) is a soluble co-formulation of long-acting and short-acting insulin analogs. The primary objective of this study was to investigate the pharmacodynamic response of once-daily IDegAsp dosing in patients with type 1 diabetes. Pharmacokinetic response, as well as safety and tolerability, were assessed as secondary objectives. METHODOLOGY This was a single-center, open-label, single-arm study. Twenty-two subjects received once-daily insulin degludec (IDeg) (0.42 U/kg) for five consecutive days [with separate bolus insulin aspart (IAsp) as needed for safety and glycemic control], to achieve clinical steady state of the basal component. On Day 6, they received a single injection of IDegAsp (0.6 U/kg, comprising 0.42 U/kg IDeg and 0.18 U/kg IAsp). Pharmacodynamic response was assessed using a 30-h euglycemic glucose clamp, with blood glucose stabilized at a target of 5.5 mmol/L. RESULTS The glucose infusion rate profile showed a rapid onset of action and a distinct peak due to IAsp, followed by a separate, flat and stable basal glucose-lowering effect due to the IDeg component. Modeling data suggested that the pharmacodynamic profile of IDegAsp was retained with twice-daily dosing (allowing for coverage of two main meals daily). IDegAsp was well tolerated and no safety issues were identified in this trial. CONCLUSIONS In conclusion, the IAsp component of IDegAsp has a fast onset of appearance and a peak covering the prandial phase, while the IDeg component has a flat and an evenly distributed pharmacokinetic profile over 24 h. IDegAsp is the first co-formulation of a basal insulin analog with an ultra-long duration of action and a mealtime insulin analog in a single soluble injection. These properties translate into clinically relevant benefits, including improved glycemic control and reduction in hypoglycemia.",2014,"IDegAsp was well tolerated and no safety issues were identified in this trial. ","['Subjects with Type 1 Diabetes Mellitus', 'patients with type 1 diabetes']","['separate bolus insulin aspart (IAsp', 'insulin aspart', 'Insulin Degludec/Insulin Aspart (IDegAsp']","['Pharmacokinetic response', 'hypoglycemia', 'Pharmacodynamic response', 'pharmacodynamic response', 'safety and tolerability']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",22.0,0.0308083,"IDegAsp was well tolerated and no safety issues were identified in this trial. ","[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Heise', 'Affiliation': 'Profil Institute for Metabolic Research, Hellersbergstr. 9, 41460, Neuss, Germany, tim.heise@profil.com.'}, {'ForeName': 'Leszek', 'Initials': 'L', 'LastName': 'Nosek', 'Affiliation': ''}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Roepstorff', 'Affiliation': ''}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Chenji', 'Affiliation': ''}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Klein', 'Affiliation': ''}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Haahr', 'Affiliation': ''}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-014-0070-2'] 490,24888256,Sitagliptin Improves the Impaired Acute Insulin Response during a Meal Tolerance Test in Japanese Patients with Type 2 Diabetes Mellitus: A Small-Scale Real-World Study.,"INTRODUCTION Several studies have shown that dipeptidyl peptidase-4 (DPP-4) inhibitors improve insulin secretion during oral glucose tolerance tests. However, the effects of DPP-4 inhibitors on impaired acute insulin responses in the postprandial state in real-world settings are unknown. Therefore, we evaluated the effects of sitagliptin on the acute insulin responses in Japanese patients with type 2 diabetes mellitus (T2DM) using meal tolerance tests. METHODS Twenty-one patients with T2DM were given a test meal (460 kcal), and plasma glucose and insulin were measured at 0, 30, 60, 120, and 180 min after the meal. The insulinogenic index of all of these patients was below 43.2. The postprandial profiles were assessed at baseline and after 3 months of treatment with 50 mg/day sitagliptin after a meal (n = 11) or were untreated (control group; n = 10). This study was a prospective, open-label, non-blinded, non-randomized, clinical study. RESULTS Sitagliptin significantly decreased the plasma glucose levels at 60, 120, and 180 min, and significantly increased the plasma insulin levels at 0 and 30 min. There were no significant changes in glucose or insulin in the control group. The insulinogenic index increased significantly in the sitagliptin group compared with the control group (+16.7 vs. +0.1, P < 0.005). However, homeostasis model assessment of insulin resistance and the insulin sensitivity index were not significant different between the two groups. CONCLUSION Administration of sitagliptin at 50 mg/day after a meal improved the impaired acute insulin response and suppressed postprandial hyperglycemia. Whereas the study is rather small and the design is suboptimal as it is not randomized and not blinded, these results suggest that sitagliptin is effective in Japanese patients with T2DM, many of whom display impaired acute insulin responses after a meal.",2014,"The insulinogenic index increased significantly in the sitagliptin group compared with the control group (+16.7 vs. +0.1, P < 0.005).","['Twenty-one patients with T2DM', 'Japanese Patients with Type 2 Diabetes Mellitus', 'Japanese patients with type 2 diabetes mellitus (T2DM) using meal tolerance tests', 'Japanese patients with T2DM']","['DPP-4 inhibitors', 'dipeptidyl peptidase-4 (DPP-4) inhibitors', 'sitagliptin', 'Sitagliptin']","['plasma glucose and insulin', 'Acute Insulin Response', 'homeostasis model assessment of insulin resistance and the insulin sensitivity index', 'glucose or insulin', 'postprandial profiles', 'insulinogenic index', 'plasma glucose levels', 'acute insulin response and suppressed postprandial hyperglycemia', 'acute insulin responses', 'plasma insulin levels']","[{'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0201777', 'cui_str': 'Tolerance test (procedure)'}]","[{'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3653297', 'cui_str': 'Dipeptidyl peptidase 4 (DPP-4) inhibitors'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}]","[{'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C1855520', 'cui_str': 'Hyperglycemia, Postprandial'}, {'cui': 'C1276042', 'cui_str': 'Plasma insulin measurement'}]",21.0,0.0228144,"The insulinogenic index increased significantly in the sitagliptin group compared with the control group (+16.7 vs. +0.1, P < 0.005).","[{'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Ohkura', 'Affiliation': 'Division of Cardiovascular Medicine, Endocrinology and Metabolism, Department of Molecular Medicine and Therapeutics, Tottori University Faculty of Medicine, Yonago, Tottori, Japan, ohkura@med.tottori-u.ac.jp.'}, {'ForeName': 'Youhei', 'Initials': 'Y', 'LastName': 'Fujioka', 'Affiliation': ''}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Sumi', 'Affiliation': ''}, {'ForeName': 'Risa', 'Initials': 'R', 'LastName': 'Nakanishi', 'Affiliation': ''}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Shiochi', 'Affiliation': ''}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': ''}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Matsuzawa', 'Affiliation': ''}, {'ForeName': 'Shoichiro', 'Initials': 'S', 'LastName': 'Izawa', 'Affiliation': ''}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Ohkura', 'Affiliation': ''}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Kato', 'Affiliation': ''}, {'ForeName': 'Shin-Ichi', 'Initials': 'S', 'LastName': 'Taniguchi', 'Affiliation': ''}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': ''}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-014-0071-1'] 491,24318416,"Triple-Blind, Prospective, Internally Controlled Comparative Study Between AbobotulinumtoxinA and OnabotulinumtoxinA for the Treatment of Facial Rhytids.","INTRODUCTION OnabotulinumtoxinA (ONA; Botox, Allergan, Irvine, CA) was discovered for cosmetic use in the mid-1980s for which it was FDA approved in April 2002. AbobotulinumtoxinA (ABO; Dysport, Valeant Pharmaceuticals International, Inc, Montreal, Quebec) was FDA approved in April 2009 for therapeutic and esthetic uses. The most recent studies make a comparison between the two formulations; however, information is still lacking in comparison studies. In this study, we compare efficacy and safety of a single treatment of two preparations of botulinum toxin A in patients with moderate to severe rhytids in the glabellar and crow's feet areas. METHODS A total of 85 patients with moderate to severe wrinkles in either the glabellar or crow's feet area, or both, were given a single injection on day 0, with ABO and ONA injected on opposite sides of the face. Follow-up assessments were done at 2 weeks, 1 month, 3 months, 4 months, and 5 months. The study end points were onset of action, change in degree of wrinkles, patient satisfaction, duration of effect, and adverse effects. RESULTS Results of onset of improvement with ABO vs. ONA in the glabellar and crow's feet regions show higher percentage of patients with earlier onset improvement with ABO. Evaluator assessment showed ABO lasted longer after 3 months in a significant number of patients in both areas, 83% with ABO vs. 48% with ONA at 4 months in the glabellar area, and 65% with ABO vs. 47% with ONA at 4 months in the crow's feet area. CONCLUSION Time to improvement showed earlier onset and longer duration of improvement in a higher percentage of individuals with ABO when compared with ONA. ABO provides a safe and effective alternative in a dose ratio of 2.5:1 and 3:1 in the glabellar and crow's feet area, respectively.",2013,"Evaluator assessment showed ABO lasted longer after 3 months in a significant number of patients in both areas, 83% with ABO vs. 48% with ONA at 4 months in the glabellar area, and 65% with ABO vs. 47% with ONA at 4 months in the crow's feet area. ","['Facial Rhytids', ""85 patients with moderate to severe wrinkles in either the glabellar or crow's feet area"", ""patients with moderate to severe rhytids in the glabellar and crow's feet areas""]","['ABO and ONA', 'AbobotulinumtoxinA and OnabotulinumtoxinA', 'botulinum toxin A', 'AbobotulinumtoxinA', 'OnabotulinumtoxinA (ONA; Botox, Allergan, Irvine, CA']","['efficacy and safety', 'onset of action, change in degree of wrinkles, patient satisfaction, duration of effect, and adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0037301', 'cui_str': 'Skin Wrinkling'}, {'cui': 'C0442019', 'cui_str': 'Glabellar (qualifier value)'}, {'cui': 'C0277939', 'cui_str': ""Crow's feet (finding)""}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C2719424', 'cui_str': 'abobotulinumtoxinA'}, {'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}, {'cui': 'C0006055', 'cui_str': 'Botulin'}, {'cui': 'C0700702', 'cui_str': 'Botox'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0037301', 'cui_str': 'Skin Wrinkling'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",85.0,0.0261414,"Evaluator assessment showed ABO lasted longer after 3 months in a significant number of patients in both areas, 83% with ABO vs. 48% with ONA at 4 months in the glabellar area, and 65% with ABO vs. 47% with ONA at 4 months in the crow's feet area. ","[{'ForeName': 'Ramtin', 'Initials': 'R', 'LastName': 'Kassir', 'Affiliation': 'Park Avenue Plastic Surgery and Dermatology, 799 Park Avenue, New York, NY, 10021, USA, drkassir@drkassir.com.'}, {'ForeName': 'Aparanjita', 'Initials': 'A', 'LastName': 'Kolluru', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kassir', 'Affiliation': ''}]",Dermatology and therapy,['10.1007/s13555-013-0033-y'] 492,24252714,Motivational interviewing and intimate partner violence: a randomized trial.,"PURPOSE To determine if motivational interviewing (MI) improves self-efficacy (primary outcome), depressive symptoms (secondary outcome), and stage-of-readiness-to-change (secondary outcome) among women in abusive relationships. METHODS Randomized controlled trial among women who experienced intimate partner violence in a current relationship over the past 12 months. Subjects were recruited from two family planning clinics (December 2007 to May 2010). The intervention included an initial face-to-face session and three telephone sessions administered 1-, 2-, and 4-months postenrollment, each using MI to identify personal goals. Controls were referred to community-based resources. Outcomes were measured by self-administered questionnaires before randomization and 6 months later. Modified intent-to-treat analyses of completed participants were conducted using multivariate analysis of variance for continuous outcomes and polytomous logistic regression for categorical outcomes. RESULTS Three hundred six eligible women were enrolled (recruitment rate = 64%); 204 completed the 6-month follow-up (completion rate = 67%). Depressive symptoms decreased to a greater extent in MI than referral women (P = .07). Self-efficacy and stage-of-readiness-to-change increased more in MI than referral women, but these differences were not statistically significant. CONCLUSIONS With a lower than projected sample size, our findings did not achieve statistical significance at the 5% level but suggest a beneficial effect of the MI intervention on reducing depressive symptoms.",2014,Depressive symptoms decreased to a greater extent in MI than referral women (P = .07).,"['women who experienced intimate partner violence in a current relationship over the past 12 months', 'Three hundred six eligible women were enrolled (recruitment rate\xa0= 64%); 204 completed the 6-month follow-up (completion rate\xa0= 67', 'and intimate partner violence', 'Subjects were recruited from two family planning clinics (December 2007 to May 2010']","['initial face-to-face session and three telephone sessions administered', 'MI intervention', 'Motivational interviewing', 'motivational interviewing (MI']","['self-efficacy (primary outcome), depressive symptoms (secondary outcome), and stage-of-readiness-to-change (secondary outcome', 'Depressive symptoms', 'depressive symptoms', 'Self-efficacy and stage-of-readiness-to-change increased more in MI']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C3840184', 'cui_str': 'Family planning clinic'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",306.0,0.126608,Depressive symptoms decreased to a greater extent in MI than referral women (P = .07).,"[{'ForeName': 'Audrey F', 'Initials': 'AF', 'LastName': 'Saftlas', 'Affiliation': 'Department of Epidemiology, University of Iowa, Iowa City, IA. Electronic address: audrey-saftlas@uiowa.edu.'}, {'ForeName': 'Karisa K', 'Initials': 'KK', 'LastName': 'Harland', 'Affiliation': 'Department of Occupational and Environmental Health, Injury Prevention Research Center, University of Iowa, Iowa City, IA; Department of Emergency Medicine, University of Iowa Hospitals and Clinics, Iowa City, IA.'}, {'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Wallis', 'Affiliation': 'Department of Epidemiology, University of Iowa, Iowa City, IA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Cavanaugh', 'Affiliation': 'Department of Biostatistics, University of Iowa, Iowa City, IA.'}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Dickey', 'Affiliation': 'Department of Occupational and Environmental Health, Planned Parenthood of the Heartland, Des Moines, IA.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Peek-Asa', 'Affiliation': 'Department of Occupational and Environmental Health, Injury Prevention Research Center, University of Iowa, Iowa City, IA.'}]",Annals of epidemiology,['10.1016/j.annepidem.2013.10.006'] 493,24643869,Clinical and biochemical assessment of maintenance treatment in chronic recurrent seborrheic dermatitis: randomized controlled study.,"INTRODUCTION Few studies have investigated the long-term effects of a maintenance regimen in the prevention of relapses in scalp seborrheic dermatitis (SD), in particular following biomarker changes. MATERIALS AND METHODS A new shampoo containing beta-glycyrrhetinic acid (18βGA) in addition to cyclopiroxolamine (CPO) and zinc pyrithione (ZP) was tested in 67 subjects suffering from SD with moderate to severe erythema and itching in a biphasic study. After a first common intensive treatment phase (investigational product thrice a week × 2 weeks), subjects randomly received the investigational product once a week × 8 weeks (maintenance) or a neutral shampoo (discontinuation) in a comparative, parallel group maintenance phase. Efficacy was assessed clinically (overall clinical dandruff score, erythema, overall efficacy, self-evaluation), biochemically and microbiologically by quantitative polymerase chain reaction (qPCR), high performance liquid chromatography (HPLC) or enzyme-linked immunoabsorbent assay (ELISA) analysis of scale samples (Malassezia species (restricta and globosa), cohesion proteins (plakoglobins), inflammation (Interleukin (IL)-8, IL-1RA/IL-1α) and pruritus (histamine, cathepsin S) markers). RESULTS During the intensive treatment phase, SD improved significantly (p < 0.0001) with a decrease in clinical signs as well as Malassezia species, cohesion proteins, inflammation and pruritus markers. During the maintenance phase, the improvement persisted in the 'maintenance' group only, with a significant intergroup difference. A consistently positive relationship was found between dandruff, itching, erythema and Malassezia populations, histamine levels and IL-1RA/IL-1α ratio. CONCLUSION The effectiveness of this maintenance regimen was objectively demonstrated at the clinical, biochemical and microbiological level. Correlations between clinical signs and biomarkers could provide clues to explain the resolution of SD and confirm the interest of biomarkers for SD treatment assessment.",2014,"During the intensive treatment phase, SD improved significantly (p < 0.0001) with a decrease in clinical signs as well as Malassezia species, cohesion proteins, inflammation and pruritus markers.","['67 subjects suffering from SD with moderate to severe erythema and itching in a biphasic study', 'chronic recurrent seborrheic dermatitis', 'scalp seborrheic dermatitis (SD']","['cyclopiroxolamine (CPO) and zinc pyrithione (ZP', 'shampoo containing beta-glycyrrhetinic acid (18βGA', 'neutral shampoo (discontinuation', 'investigational product once a week']","['Efficacy', 'Malassezia species, cohesion proteins, inflammation and pruritus markers', 'dandruff, itching, erythema and Malassezia populations, histamine levels and IL-1RA/IL-1α ratio', 'clinical dandruff score, erythema, overall efficacy, self-evaluation), biochemically and microbiologically by quantitative polymerase chain reaction (qPCR), high performance liquid chromatography (HPLC) or enzyme-linked immunoabsorbent assay (ELISA) analysis of scale samples (Malassezia species (restricta and globosa), cohesion proteins (plakoglobins), inflammation (Interleukin (IL)-8, IL-1RA/IL-1α) and pruritus (histamine, cathepsin S) markers']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0205184', 'cui_str': 'Biphasic (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0036508', 'cui_str': 'Seborrhea'}, {'cui': 'C0036270', 'cui_str': 'Scalp'}]","[{'cui': 'C0078792', 'cui_str': 'zinc pyrithione'}, {'cui': 'C1554936', 'cui_str': 'Shampoo - dosing instruction imperative'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0017986', 'cui_str': 'enoxolone'}, {'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}]","[{'cui': 'C0024541', 'cui_str': 'Pityrosporum'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0423775', 'cui_str': 'Scurfiness of skin (finding)'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1168027', 'cui_str': 'Histamine level'}, {'cui': 'C1704264', 'cui_str': 'IL-1 Inhibitor, Urine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2936633', 'cui_str': 'Self-Evaluation'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0032520', 'cui_str': 'PCR'}, {'cui': 'C0008562', 'cui_str': 'Chromatography, High Speed Liquid'}, {'cui': 'C3541394', 'cui_str': 'Enzymes'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0222045'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0019588', 'cui_str': 'Histamine'}, {'cui': 'C0054874', 'cui_str': 'cathepsin S'}]",67.0,0.0891739,"During the intensive treatment phase, SD improved significantly (p < 0.0001) with a decrease in clinical signs as well as Malassezia species, cohesion proteins, inflammation and pruritus markers.","[{'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Turlier', 'Affiliation': 'Service Exploration Clinique, Hôtel Dieu, Toulouse, France, virginie.turlier@pierre-fabre.com.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Viode', 'Affiliation': ''}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Durbise', 'Affiliation': ''}, {'ForeName': 'Adeline', 'Initials': 'A', 'LastName': 'Bacquey', 'Affiliation': ''}, {'ForeName': 'Ophélie', 'Initials': 'O', 'LastName': 'LeJeune', 'Affiliation': ''}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Oliveira Soares', 'Affiliation': ''}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lauze', 'Affiliation': ''}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Villeneuve', 'Affiliation': ''}, {'ForeName': 'Amandine', 'Initials': 'A', 'LastName': 'Rouquier', 'Affiliation': ''}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Casas', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Redoules', 'Affiliation': ''}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Mengeaud', 'Affiliation': ''}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Schmitt', 'Affiliation': ''}]",Dermatology and therapy,['10.1007/s13555-014-0047-0'] 494,24297647,Cellulite and focused extracorporeal shockwave therapy for non-invasive body contouring: a randomized trial.,"INTRODUCTION Focused extracorporeal shockwave therapy (ESWT) has been demonstrated to improve wound healing and skin regeneration such as in burn wounds and scars. We hypothesized that the combination of focused ESWT and a daily gluteal muscle strength program is superior to SHAM-ESWT and gluteal muscle strength training in moderate to severe cellulite. METHODS This was a single-center, double-blinded, randomized-controlled trial. For allocation of participants, a 1:1 ratio randomization was performed using opaque envelopes for the concealment of allocation. Eligible patients were females aged 18-65 years with cellulite. The primary outcome parameter was the photo-numeric Cellulite Severity Scale (CSS) determined by two blinded, independent assessors. The intervention group (group A) received six sessions of focused ESWT (2,000 impulses, 0.35 mJ/mm(2), every 1-2 weeks) at both gluteal and thigh regions plus specific gluteal strength exercise training. The control group (group B) received six sessions of SHAM-ESWT plus specific gluteal strength exercise training. RESULTS The CSS in group A was 10.9 ± 3.8 (mean ± SE) before intervention and 8.3 ± 4.1 after 12 weeks (P = 0.001, 2.53 improvement, 95% confidence interval (CI) 1.43-3.62). The CSS in group B was 10.0 ± 3.8 before intervention and 10.1 ± 3.8 after 12 weeks (P = 0.876, 95% CI 1.1-0.97). The change of the CSS in group A versus group B was significantly different (P = 0.001, -24.3 effect size, 95% CI -36.5 to -12.1). CONCLUSION The combination of non-invasive, focused ESWT (0.35 mJ/mm(2), 2,000 impulses, 6 sessions) in combination with gluteal strength training was superior to gluteal strength training and SHAM-ESWT in moderate to severe cellulite in terms of the CSS in a 3-month perspective. Long-term results have to be evaluated in terms of the sustainability of these effects.",2013,"4.1 after 12 weeks (P = 0.001, 2.53 improvement, 95% confidence interval (CI) 1.43-3.62).","['non-invasive body contouring', 'Eligible patients were females aged 18-65\xa0years with cellulite']","['gluteal strength training was superior to gluteal strength training and SHAM-ESWT', 'extracorporeal shockwave therapy (ESWT', 'six sessions of focused ESWT (2,000 impulses, 0.35\xa0mJ/mm(2), every 1-2\xa0weeks) at both gluteal and thigh regions plus specific gluteal strength exercise training', 'extracorporeal shockwave therapy', 'SHAM-ESWT plus specific gluteal strength exercise training']",['photo-numeric Cellulite Severity Scale (CSS'],"[{'cui': 'C0205303', 'cui_str': 'Non-invasive (qualifier value)'}, {'cui': 'C2224569', 'cui_str': 'Body Lift Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0424624', 'cui_str': 'Cellulite'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}, {'cui': 'C0443235', 'cui_str': 'Impulse (qualifier value)'}, {'cui': 'C4517451', 'cui_str': 'Zero point three five'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0039866', 'cui_str': 'Thigh'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0424624', 'cui_str': 'Cellulite'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}]",,0.128099,"4.1 after 12 weeks (P = 0.001, 2.53 improvement, 95% confidence interval (CI) 1.43-3.62).","[{'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Knobloch', 'Affiliation': 'SportPraxis, Heiligerstr. 3, Hannover, Germany, professor.knobloch@sportpraxis-knobloch.de.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Joest', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Krämer', 'Affiliation': ''}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Vogt', 'Affiliation': ''}]",Dermatology and therapy,['10.1007/s13555-013-0039-5'] 495,24619816,Evaluation of a Pseudoceramide Moisturizer in Patients with Mild-to-Moderate Atopic Dermatitis.,"INTRODUCTION To evaluate the efficacy and safety of a pseudoceramide-containing moisturizer as maintenance therapy in patients with mild-to-moderate atopic dermatitis (AD). METHODS This was a prospective, single-arm, open-label clinical trial of a twice-daily application of a pseudoceramide-containing moisturizer for 4 weeks as maintenance therapy in 40 patients with stable, mild-to-moderate AD in a tropical climate. Clinical and skin barrier assessment was done at week 0, week 2 and week 4. Any adverse effects were also recorded during the study period. RESULTS The objective scoring atopic dermatitis decreased from 29.1 [interquartile range (IQR) 21.9-33.7] at week 0 to 22.0 (IQR 21.2-27.8) at week 4 (p < 0.001). There was no detectable difference in transepidermal water loss after 4 weeks; however, stratum corneum (SC) hydration was significantly increased from 39.7 (IQR 35.3-46.4) at week 0 to 49.2 (IQR 41.2-54.6) after 4 weeks (p < 0.001). Both Dermatology Life Quality Index and patient-oriented eczema measure showed significant improvement at week 4 (p < 0.001). The moisturizer was well tolerated with no serious adverse events recorded. CONCLUSION After 4 weeks of barrier maintenance therapy with a pseudoceramide moisturizer, there was a significant improvement in disease severity, SC hydration and quality of life in both pediatric and adult patients with mild-to-moderate AD.",2014,Both Dermatology Life Quality Index and patient-oriented eczema measure showed significant improvement at week 4 (p < 0.001).,"['40 patients with stable, mild-to-moderate AD in a tropical climate', 'patients with mild-to-moderate atopic dermatitis (AD', 'Patients with Mild-to-Moderate Atopic Dermatitis']","['pseudoceramide-containing moisturizer', 'Pseudoceramide Moisturizer']","['disease severity, SC hydration and quality of life', 'objective scoring atopic dermatitis', 'efficacy and safety', 'stratum corneum (SC) hydration', 'adverse effects', 'Clinical and skin barrier assessment', 'transepidermal water loss']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0041183', 'cui_str': 'Tropical Climate'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}]","[{'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0034380'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0221921', 'cui_str': 'Stratum corneum structure'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0043047', 'cui_str': 'Water'}]",40.0,0.0411657,Both Dermatology Life Quality Index and patient-oriented eczema measure showed significant improvement at week 4 (p < 0.001).,"[{'ForeName': 'Amelie Clementine', 'Initials': 'AC', 'LastName': 'Seghers', 'Affiliation': 'National Skin Center, 1 Mandalay Road, Novena, Singapore.'}, {'ForeName': 'Sophie Chan', 'Initials': 'SC', 'LastName': 'Cai', 'Affiliation': ''}, {'ForeName': 'Madeleine Sheun Ling', 'Initials': 'MS', 'LastName': 'Ho', 'Affiliation': ''}, {'ForeName': 'Yoke Chin', 'Initials': 'YC', 'LastName': 'Giam', 'Affiliation': ''}, {'ForeName': 'Lucinda', 'Initials': 'L', 'LastName': 'Tan', 'Affiliation': ''}, {'ForeName': 'Carina Marie', 'Initials': 'CM', 'LastName': 'Grönhagen', 'Affiliation': ''}, {'ForeName': 'Mark Boon Yang', 'Initials': 'MB', 'LastName': 'Tang', 'Affiliation': ''}]",Dermatology and therapy,['10.1007/s13555-014-0048-z'] 496,24595638,Impact of dronedarone treatment on healthcare resource utilization in patients with atrial fibrillation/flutter.,"BACKGROUND The ATHENA (A Placebo-Controlled, Double-Blind, Parallel Arm Trial to Assess the Efficacy of Dronedarone 400 mg bid for the Prevention of Cardiovascular Hospitalization or Death from Any Cause in Patients with Atrial Fibrillation/Atrial Flutter) trial demonstrated a significant reduction (26%) in the rate of first cardiovascular (CV) hospitalization in dronedarone-treated patients with paroxysmal or persistent atrial fibrillation/flutter (AF/AFL). ATHENA was the first trial to demonstrate a CV outcomes benefit, specifically reduced CV hospitalizations, with an antiarrhythmic drug. The objective of this study was to assess the impact of dronedarone treatment on healthcare resource utilization among real-world patients with AF/AFL in United States clinical practice. METHODS This retrospective cohort study used claims data from the MarketScan® databases (Truven Health, Durham, NC, USA) to identify patients with ≥2 concurrent de novo pharmacy claims for dronedarone (≥180 days' total supply) between June 2009 and March 2011, and with an AF/AFL diagnosis and no heart failure-related hospitalization during the 12 months preceding the initial (index) dronedarone claim. Annualized inpatient and outpatient resource utilization were compared between the pre-index (baseline) and post-index (follow-up) periods. RESULTS In total, 5,656 AF/AFL patients were prescribed dronedarone for ≥6 months and were followed for mean (standard deviation) 11.9 (4.7) months. Reductions in mean numbers of annualized all-cause, CV- and AF-related hospitalizations (~40-45%), and emergency department visits (~30-45%) were realized. These benefits were offset by increases in office visits (~10-30%) and AF-related prescription claims (74%) after dronedarone initiation. The sub-cohort of patients switching to dronedarone from Prior Rhythm-Control therapy (n=2,080) showed similar reductions in hospital and emergency department events. CONCLUSIONS This study suggests that dronedarone use in real-world practice, as in the ATHENA trial, results in substantial reductions in hospital admissions, both in first-line and second-line antiarrhythmic treatment settings.",2014,mg bid for the Prevention of Cardiovascular Hospitalization or Death from Any Cause in Patients with Atrial Fibrillation/Atrial Flutter) trial demonstrated a significant reduction (26%) in the rate of first cardiovascular (CV) hospitalization in dronedarone-treated patients with paroxysmal or persistent atrial fibrillation/flutter (AF/AFL).,"['patients with atrial fibrillation/flutter', 'Patients with Atrial Fibrillation/Atrial Flutter', 'real-world patients with AF/AFL in United States clinical practice', 'treated patients with paroxysmal or persistent atrial fibrillation/flutter (AF/AFL']","['Placebo', 'dronedarone from Prior Rhythm-Control therapy', 'dronedarone', 'Dronedarone 400']","['rate of first cardiovascular (CV) hospitalization', 'Cardiovascular Hospitalization or Death', 'Annualized inpatient and outpatient resource utilization', 'office visits', 'emergency department visits', 'healthcare resource utilization', 'hospital and emergency department events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0004239', 'cui_str': 'Auricular Flutter'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205311', 'cui_str': 'Paroxysmal (qualifier value)'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0766326', 'cui_str': 'dronedarone'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}]","[{'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0028900', 'cui_str': 'Office Visits'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",5656.0,0.0917472,mg bid for the Prevention of Cardiovascular Hospitalization or Death from Any Cause in Patients with Atrial Fibrillation/Atrial Flutter) trial demonstrated a significant reduction (26%) in the rate of first cardiovascular (CV) hospitalization in dronedarone-treated patients with paroxysmal or persistent atrial fibrillation/flutter (AF/AFL).,"[{'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Kim', 'Affiliation': 'Warren Alpert Medical School of Brown University and Lifespan Cardiovascular Institute, 593 Eddy Street, APC 739, Providence, RI, USA, mkim4@lifespan.org.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Mehul', 'Initials': 'M', 'LastName': 'Jhaveri', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Koren', 'Affiliation': ''}]",Advances in therapy,['10.1007/s12325-014-0108-x'] 497,24474552,Cardio- and cerebrovascular responses to the energy drink Red Bull in young adults: a randomized cross-over study.,"PURPOSE Energy drinks are beverages containing vasoactive metabolites, usually a combination of caffeine, taurine, glucuronolactone and sugars. There are concerns about the safety of energy drinks with some countries banning their sales. We determined the acute effects of a popular energy drink, Red Bull, on cardiovascular and hemodynamic variables, cerebrovascular parameters and microvascular endothelial function. METHODS Twenty-five young non-obese and healthy subjects attended two experimental sessions on separate days according to a randomized crossover study design. During each session, primary measurements included beat-to-beat blood pressure measurements, impedance cardiography and transcranial Doppler measurements for at least 20 min baseline and for 2 h following the ingestion of either 355 mL of the energy drink or 355 mL of tap water; the endothelial function test was performed before and two hours after either drink. RESULTS Unlike the water control load, Red Bull consumption led to increases in both systolic and diastolic blood pressure (p < 0.005), associated with increased heart rate and cardiac output (p < 0.05), with no significant changes in total peripheral resistance and without diminished endothelial response to acetylcholine; consequently, double product (reflecting myocardial load) was increased (p < 0.005). Red Bull consumption also led to increases in cerebrovascular resistance and breathing frequency (p < 0.005), as well as to decreases in cerebral blood flow velocity (p < 0.005) and end-tidal carbon dioxide (p < 0.005). CONCLUSION Our results show an overall negative hemodynamic profile in response to ingestion of the energy drink Red Bull, in particular an elevated blood pressure and double product and a lower cerebral blood flow velocity.",2014,"Red Bull consumption also led to increases in cerebrovascular resistance and breathing frequency (p < 0.005), as well as to decreases in cerebral blood flow velocity (p < 0.005) and end-tidal carbon dioxide (p < 0.005). ","['Twenty-five young non-obese and healthy subjects', 'young adults']","['caffeine, taurine, glucuronolactone and sugars']","['beat-to-beat blood pressure measurements, impedance cardiography and transcranial Doppler measurements', 'heart rate and cardiac output', 'cerebrovascular resistance and breathing frequency', 'cerebral blood flow velocity', 'elevated blood pressure and double product and a lower cerebral blood flow velocity', 'cardiovascular and hemodynamic variables, cerebrovascular parameters and microvascular endothelial function', 'endothelial response', 'endothelial function test', 'end-tidal carbon dioxide', 'total peripheral resistance', 'Cardio- and cerebrovascular responses', 'systolic and diastolic blood pressure']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0039350', 'cui_str': 'Taurine'}, {'cui': 'C0061446', 'cui_str': 'glucuronolactone'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}]","[{'cui': 'C0005824', 'cui_str': 'Blood pressure taking (procedure)'}, {'cui': 'C0007185', 'cui_str': 'Plethysmography, Impedance, Transthoracic'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0497247', 'cui_str': 'Finding of increased blood pressure (finding)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C1258192', 'cui_str': 'Total Peripheral Resistance'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}]",25.0,0.0789028,"Red Bull consumption also led to increases in cerebrovascular resistance and breathing frequency (p < 0.005), as well as to decreases in cerebral blood flow velocity (p < 0.005) and end-tidal carbon dioxide (p < 0.005). ","[{'ForeName': 'Erik K', 'Initials': 'EK', 'LastName': 'Grasser', 'Affiliation': 'Laboratory of Integrative Cardiovascular and Metabolic Physiology, Division of Physiology, Department of Medicine, University of Fribourg, Chemin du Musée 5, 1700, Fribourg, Switzerland, erikkonrad.grasser@unifr.ch.'}, {'ForeName': 'Gayathri', 'Initials': 'G', 'LastName': 'Yepuri', 'Affiliation': ''}, {'ForeName': 'Abdul G', 'Initials': 'AG', 'LastName': 'Dulloo', 'Affiliation': ''}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Montani', 'Affiliation': ''}]",European journal of nutrition,['10.1007/s00394-014-0661-8'] 498,24415271,Zofenopril plus hydrochlorothiazide and irbesartan plus hydrochlorothiazide in previously treated and uncontrolled diabetic and non-diabetic essential hypertensive patients.,"INTRODUCTION In most treated patients with hypertension, a two or more drug combination is required to achieve adequate blood pressure (BP) control. In our study we assessed whether the combination of zofenopril + hydrochlorothiazide (HCTZ) was at least as effective as irbesartan + HCTZ in essential hypertensives with at least one additional cardiovascular risk factor, uncontrolled by a previous monotherapy. METHODS After a 2-week placebo washout, 361 treated hypertensive patients [office sitting diastolic BP (DBP), ≥90 mmHg], aged 18-75 years, were randomized double blind to 18-week treatment with zofenopril 30 mg plus HCTZ 12.5 mg or irbesartan 150 mg plus HCTZ 12.5 mg once daily, in an international, multicenter study. After the first 6 and 12 weeks, zofenopril and irbesartan doses could be doubled in non-normalized subjects. The primary study end point was the office sitting DBP reduction after 18 weeks of treatment. Secondary end points included office systolic BP (SBP), ambulatory BP and high sensitivity C-reactive protein (hs-CRP). RESULTS The between-treatment difference for office DBP averaged to +1.0 (95% CI -0.4, +0.8) mmHg (P = 0.150), the upper limit of the 95% confidence interval being inferior to the protocol-defined non-inferiority limit (3 mmHg). In the subset of patients with valid ambulatory BP, no difference in 24-h average DBP [n = 181; 6.7 (8.7, 4.6) zofenopril + HCTZ vs. 6.3 (8.8, 3.7) mmHg irbesartan + HCTZ, P = 0.810] and SBP reductions [11.7 (15.4, 8.0) vs. 12.6 (17.2, 8.0) mmHg, P = 0.758] were observed between the two treatment groups. hs-CRP was reduced by zofenopril + HCTZ [-0.52 (-1.05, 0.01) mg/L], while it was increased by irbesartan plus HCTZ [0.97 (0.29, 1.65) mg/L, P = 0.001 between treatments]. CONCLUSION In previously monotherapy-treated, uncontrolled patients with hypertension, zofenopril 30-60 mg + HCTZ 12.5 mg is as effective as irbesartan 150-300 mg plus HCTZ 12.5 mg, with the added value of a potential protective effect against vascular inflammation.",2014,"The between-treatment difference for office DBP averaged to +1.0 (95% CI -0.4, +0.8) mmHg (P = 0.150), the upper limit of the 95% confidence interval being inferior to the protocol-defined non-inferiority limit (3 mmHg).","['previously treated and uncontrolled diabetic and non-diabetic essential hypertensive patients', '361 treated hypertensive patients [office sitting diastolic BP (DBP), ≥90\xa0mmHg], aged 18-75\xa0years']","['zofenopril 30-60\xa0mg\xa0+\xa0HCTZ', 'placebo', 'zofenopril 30\xa0mg plus HCTZ 12.5\xa0mg or irbesartan 150\xa0mg plus HCTZ', 'HCTZ', 'zofenopril\xa0+\xa0HCTZ ', 'zofenopril\xa0+\xa0hydrochlorothiazide (HCTZ', 'Zofenopril plus hydrochlorothiazide and irbesartan plus hydrochlorothiazide', 'zofenopril']","['SBP reductions', 'office systolic BP (SBP), ambulatory BP and high sensitivity C-reactive protein (hs-CRP', 'office sitting DBP reduction', '24-h average DBP', 'office DBP', 'hs-CRP', 'adequate blood pressure (BP) control']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0205224', 'cui_str': 'Essential (qualifier value)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0078836', 'cui_str': 'zofenopril'}, {'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4517544', 'cui_str': '12.5 (qualifier value)'}, {'cui': 'C0986849', 'cui_str': 'irbesartan 150 MG'}, {'cui': 'C0288171', 'cui_str': 'irbesartan'}]","[{'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",361.0,0.0330466,"The between-treatment difference for office DBP averaged to +1.0 (95% CI -0.4, +0.8) mmHg (P = 0.150), the upper limit of the 95% confidence interval being inferior to the protocol-defined non-inferiority limit (3 mmHg).","[{'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Agabiti-Rosei', 'Affiliation': 'Division of Medicine and Surgery, Spedali Civili and University of Brescia, Brescia, Italy.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Manolis', 'Affiliation': ''}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Zava', 'Affiliation': ''}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Omboni', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Advances in therapy,['10.1007/s12325-013-0090-8'] 499,24132613,Incretin therapy for type 2 diabetes in Spain: a cost-effectiveness analysis of liraglutide versus sitagliptin.,"INTRODUCTION Treatment with glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors, which target the incretin axis, has the potential to improve glycemic control in type 2 diabetes patients without the weight gain associated with traditional therapies. To evaluate the relative cost-effectiveness of incretin therapies, the present study aimed to compare the long-term clinical and cost implications associated with liraglutide and sitagliptin in type 2 diabetes patients in Spain. METHODS Data were taken from a randomized, controlled trial (NCT00700817) in which adults with type 2 diabetes failing metformin monotherapy were randomly allocated to receive either liraglutide 1.2 mg or sitagliptin 100 mg daily in addition to metformin. Long-term projections of clinical outcomes and direct costs (2012 EUR) based on observed treatment effects were made using a published and validated type 2 diabetes model. Costs were taken from published sources. Future costs and clinical benefits were discounted at 3% annually. Sensitivity analyses were performed. RESULTS Liraglutide was associated with improved discounted life expectancy (14.05 versus 13.91 years) and quality-adjusted life expectancy [9.04 versus 8.87 quality-adjusted life years (QALYs)] compared to sitagliptin. Improved clinical outcomes were driven by improved glycemic control, leading to reduced incidence of diabetes-related complications, including renal disease, cardiovascular disease, ophthalmic and diabetic foot complications. Liraglutide was associated with increased direct costs of EUR 2,297, yielding an incremental cost-effectiveness ratio of EUR 13,266 per QALY gained versus sitagliptin. CONCLUSIONS Liraglutide was projected to improve life expectancy, quality-adjusted life expectancy and reduce incidence of diabetes-related complication. Liraglutide is likely to be cost-effective versus sitagliptin from a healthcare payer perspective in Spain.",2013,"Liraglutide was associated with increased direct costs of EUR 2,297, yielding an incremental cost-effectiveness ratio of EUR 13,266 per QALY gained versus sitagliptin. ","['type 2 diabetes patients in Spain', 'type 2 diabetes patients without the weight gain associated with traditional therapies', 'type 2 diabetes in Spain', 'adults with type 2 diabetes failing metformin monotherapy']","['liraglutide 1.2\xa0mg or sitagliptin 100\xa0mg daily in addition to metformin', 'Liraglutide', 'liraglutide versus sitagliptin', 'glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors', 'liraglutide and sitagliptin', 'Incretin therapy']","['renal disease, cardiovascular disease, ophthalmic and diabetic foot complications', 'Future costs and clinical benefits', 'incremental cost-effectiveness ratio of EUR', 'quality-adjusted life expectancy', 'discounted life expectancy', 'life expectancy, quality-adjusted life expectancy']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C3650840', 'cui_str': 'Traditional therapy (regime/therapy)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C1812980', 'cui_str': 'sitagliptin 100 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl-Peptidase 4 Inhibitors'}, {'cui': 'C1562292', 'cui_str': 'Glucose-Dependent Insulin-Releasing Hormone'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0206172', 'cui_str': 'Diabetic Foot'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}]",,0.028429,"Liraglutide was associated with increased direct costs of EUR 2,297, yielding an incremental cost-effectiveness ratio of EUR 13,266 per QALY gained versus sitagliptin. ","[{'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Mezquita Raya', 'Affiliation': 'Clinica San Pedro, Hospital Torrecardenas, Almería, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pérez', 'Affiliation': ''}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ramírez de Arellano', 'Affiliation': ''}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Briones', 'Affiliation': ''}, {'ForeName': 'Barnaby', 'Initials': 'B', 'LastName': 'Hunt', 'Affiliation': ''}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Valentine', 'Affiliation': ''}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-013-0044-9'] 500,24658882,High flexion knee arthroplasty: the relationship between rotational angles and flexion angle after total knee arthroplasty.,"The current patients required high flexion total knee arthroplasty (TKA). We hypothesized the patients who would get the high rotational angle just after TKA could gain high flexion knee 1 year after TKA. Sixty-three patients (average age: 70.6 years) were examined. In order to examine between the intraoperative rotational angles and the gained flexion angles after TKA, the patients were divided into two groups: the H group (more than 120°) and the L groups (less than 120°) by the gained flexion angles. The relationship between the flexion angles at 1 year after surgery and the intraoperative rotational angle had no significant correlation. But the rotational angles in the L group tended to be higher than the ones in the H group, and at only 30°, the L group gained significantly more rotational angle than the H group. These results might show that a tighter rotational stability induces a gain of higher flexion knee after TKA.",2014,The relationship between the flexion angles at 1 year after surgery and the intraoperative rotational angle had no significant correlation.,"['Sixty-three patients (average age: 70.6\xa0years', 'total knee arthroplasty', 'High flexion knee arthroplasty']",[],"['high flexion total knee arthroplasty (TKA', 'rotational angle']","[{'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0445237', 'cui_str': 'Rotational (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}]",,0.0185635,The relationship between the flexion angles at 1 year after surgery and the intraoperative rotational angle had no significant correlation.,"[{'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Deie', 'Affiliation': 'Institute of Biomechanical and Health Sciences, Laboratory of Musculoskeletal Functional Research and Regeneration, Hiroshima University, 1-2-3 Kasumi, Minami-ku, Hiroshima, Japan, 734-8553, snm3@hiroshima-u.ac.jp.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Nakasa', 'Affiliation': ''}, {'ForeName': 'Goki', 'Initials': 'G', 'LastName': 'Kamei', 'Affiliation': ''}, {'ForeName': 'Atsuo', 'Initials': 'A', 'LastName': 'Nakamae', 'Affiliation': ''}, {'ForeName': 'Mitsuo', 'Initials': 'M', 'LastName': 'Ochi', 'Affiliation': ''}]",Current reviews in musculoskeletal medicine,['10.1007/s12178-014-9215-1'] 501,24535625,"Safety, pharmacokinetics, and pharmacodynamics of single and multiple luseogliflozin dosing in healthy Japanese males: a randomized, single-blind, placebo-controlled trial.","INTRODUCTION Luseogliflozin, a sodium glucose cotransporter 2 inhibitor, inhibits reabsorption of glucose in the proximal renal tubule. It was developed for the treatment of type 2 diabetes mellitus. METHODS For this first human study of luseogliflozin, randomized, single-blind, placebo-controlled, single ascending dose (1-25 mg) and multiple ascending dose (5 or 10 mg/day, 7 days) trials were conducted in healthy male Japanese subjects to investigate safety, pharmacokinetics, and pharmacodynamics. RESULTS There were no serious adverse events, adverse events leading to discontinuation, or episodes of hypoglycemia. After administration of a single oral dose of luseogliflozin, its maximum plasma level (C max) and area under the concentration-time curve increased in a dose-dependent manner, and no food effects were observed on pharmacokinetics. The mean time taken to reach C max (T max) ranged from 0.667 to 2.25 h. The mean plasma half-life of luseogliflozin (T 1/2) after multiple dosing for 7 days ranged from 9.14 to 10.7 h, and no detectable accumulation of luseogliflozin was observed. Urinary glucose excretion increased in a dose-dependent manner, ranging from 18.9 to 70.9 g (single-dose study). CONCLUSION Luseogliflozin was well tolerated and showed favorable pharmacokinetic and pharmacodynamic profiles in healthy male Japanese subjects.",2014,The mean time taken to reach C max (T max) ranged from 0.667 to 2.25 h.,"['healthy male Japanese subjects', 'healthy Japanese males']","['single and multiple luseogliflozin', 'luseogliflozin', 'placebo', 'Luseogliflozin']","['serious adverse events, adverse events leading to discontinuation, or episodes of hypoglycemia', 'mean time taken to reach C max (T max', 'mean plasma half-life of luseogliflozin', 'maximum plasma level (C max) and area under the concentration-time curve', 'Urinary glucose excretion', 'Safety, pharmacokinetics, and pharmacodynamics']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C2933904', 'cui_str': '1,5-anhydro-1-(5-(4-ethoxybenzyl)-2-methoxy-4-methylphenyl)-1-thioglucitol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C2933904', 'cui_str': '1,5-anhydro-1-(5-(4-ethoxybenzyl)-2-methoxy-4-methylphenyl)-1-thioglucitol'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}]",,0.0384865,The mean time taken to reach C max (T max) ranged from 0.667 to 2.25 h.,"[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Sasaki', 'Affiliation': 'Division of Diabetes and Endocrinology, The Jikei University Graduate School of Medical Research, 3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo, 105-8461, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Seino', 'Affiliation': ''}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Fukatsu', 'Affiliation': ''}, {'ForeName': 'Soichi', 'Initials': 'S', 'LastName': 'Sakai', 'Affiliation': ''}, {'ForeName': 'Yoshishige', 'Initials': 'Y', 'LastName': 'Samukawa', 'Affiliation': ''}]",Advances in therapy,['10.1007/s12325-014-0102-3'] 502,24293132,"The fixed-dose combination of olmesartan/amlodipine was superior in central aortic blood pressure reduction compared with perindopril/amlodipine: a randomized, double-blind trial in patients with hypertension.","INTRODUCTION Central blood pressure (BP), an important measure of cardiovascular risk, has been shown to be effectively reduced by calcium channel blockade with amlodipine (AML) plus renin-angiotensin system blockade by the angiotensin-converting enzyme inhibitor, perindopril (PER). The aim of the SEVITENSION study was to compare the central effects of PER/AML against renin-angiotensin system blockade with the angiotensin II receptor blocker olmesartan (OLM) plus AML. METHODS In this multicenter, parallel group, non-inferiority study, patients received AML 10 mg during a 2- to 4-week run-in before randomization to 24 weeks of double-blind treatment with the fixed-dose combination of OLM/AML 40/10 mg or PER/AML 8/10 mg. Hydrochlorothiazide was added at Weeks 4, 8, or 12 in patients with inadequate BP control. The primary efficacy variable was the absolute change in central systolic BP (CSBP) from baseline to the final examination, measured by radial artery applanation tonometry and analyzed by parametric analysis of covariance. Secondary variables included 24-h ambulatory and seated BP measurements as well as BP normalization. RESULTS Of 600 patients enrolled, 486 were randomized (244 to OLM/AML 40/10 mg, 242 to PER/AML 8/10 mg). The reduction in CSBP was larger with OLM/AML (14.5 ± 0.83 mmHg) than with PER/AML (10.4 ± 0.84 mmHg). The between-group difference was -4.2 ± 1.18 mmHg with 95% confidence intervals (-6.48 to -1.83 mmHg) within the predefined non-inferiority margin (2 mmHg). An integrated superiority test confirmed that OLM/AML was superior to PER/AML (p < 0.0001) in reducing CSBP. The superiority of OLM/AML over PER/AML was also established for the majority of secondary efficacy variables; at the final examination, 75.6% of OLM/AML recipients achieved BP normalization (mean seated systolic BP/diastolic BP <140/90 mmHg) compared with 57.5% of PER/AML recipients (p < 0.0001). CONCLUSION The combination of OLM/AML was superior to PER/AML in reducing CSBP and other efficacy measures, including a significantly higher rate of BP normalization.",2013,An integrated superiority test confirmed that OLM/AML was superior to PER/AML (p < 0.0001) in reducing CSBP.,"['patients with hypertension', '600 patients enrolled, 486 were randomized (244 to']","['OLM/AML 40/10 mg or PER/AML', 'OLM/AML', 'amlodipine', 'olmesartan/amlodipine', 'angiotensin II receptor blocker olmesartan (OLM) plus AML', 'Hydrochlorothiazide', 'AML', 'perindopril/amlodipine']","['CSBP', '24-h ambulatory and seated BP measurements as well as BP normalization', 'absolute change in central systolic BP (CSBP', 'rate of BP normalization', 'radial artery applanation tonometry', 'central aortic blood pressure reduction', 'BP normalization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4517660', 'cui_str': 'Two hundred and forty-four'}]","[{'cui': 'C0327004', 'cui_str': 'Olm'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C1098320', 'cui_str': 'olmesartan'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II Receptor Blockers'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}, {'cui': 'C0136123', 'cui_str': 'Perindopril'}]","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C1283233', 'cui_str': 'Seating'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0162857', 'cui_str': 'Radial Artery'}, {'cui': 'C0430862', 'cui_str': 'Applanation tonometry (procedure)'}, {'cui': 'C0456180', 'cui_str': 'Aortic Blood Pressure'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",600.0,0.273227,An integrated superiority test confirmed that OLM/AML was superior to PER/AML (p < 0.0001) in reducing CSBP.,"[{'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Ruilope', 'Affiliation': 'Hypertension Unit, Hospital 12 de Octubre, 28041, Madrid, Spain, ruilope@ad-hocbox.com.'}, {'ForeName': 'Angie', 'Initials': 'A', 'LastName': 'Schaefer', 'Affiliation': ''}]",Advances in therapy,['10.1007/s12325-013-0076-6'] 503,24282104,Effects of switching from insulin glargine or detemir to insulin degludec in patients with type 1 diabetes mellitus.,"INTRODUCTION Insulin degludec is a new, ultra-long-acting basal insulin. The aim of this study was to analyze the changes of basal insulin dose and blood glucose profile in basal-bolus therapy of type 1 diabetes mellitus (T1DM) at the switching of basal insulin from insulin glargine or detemir to insulin degludec. METHODS Sixteen patients with T1DM were enrolled. The patients underwent continuous glucose monitoring before and after the switching of insulin glargine or detemir to degludec. Ten patients treated with insulin glargine or detemir twice daily, were switched to insulin degludec with 80-90% of the prior insulin dose. The remaining six patients treated with insulin glargine once daily, were switched to insulin degludec without down titration. The changes of daily insulin dose and glycated hemoglobin (HbA1c) were also examined for 12 weeks after switching to insulin degludec. RESULTS In the patients switched from twice-daily basal insulin, no significant difference was found between before and after switching in the blood glucose profile. In the once-daily group, blood glucose levels showed a tendency to decrease after switching to the degludec treatment. During the study period, total daily insulin dose (TDD) and total daily basal insulin dose (TBD) decreased significantly in the twice-daily group, and TDD and TBD showed a tendency to decrease after switching to degludec in the once-daily group. In both groups, the changes of HbA1c were not significantly different. CONCLUSION It is possible to achieve similar glycemic control with once-daily injection and lower doses of insulin degludec in patients with T1DM who have been treated with insulin glargine or detemir.",2013,"In the once-daily group, blood glucose levels showed a tendency to decrease after switching to the degludec treatment.","['patients with T1DM who have been treated with', 'Sixteen patients with T1DM were enrolled', 'patients with type 1 diabetes mellitus', 'type 1 diabetes mellitus (T1DM']","['insulin glargine or detemir', 'switching from insulin glargine', 'insulin glargine', 'insulin glargine or detemir to degludec']","['changes of daily insulin dose and glycated hemoglobin (HbA1c', 'basal insulin dose and blood glucose profile', 'blood glucose levels', 'blood glucose profile', 'changes of HbA1c', 'total daily insulin dose (TDD) and total daily basal insulin dose (TBD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0011854', 'cui_str': 'Diabetes Mellitus, Type 1'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",16.0,0.0256157,"In the once-daily group, blood glucose levels showed a tendency to decrease after switching to the degludec treatment.","[{'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Kusunoki', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Hyogo, 663-8501, Japan, ykusu@hyo-med.ac.jp.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Katsuno', 'Affiliation': ''}, {'ForeName': 'Kana', 'Initials': 'K', 'LastName': 'Miyakoshi', 'Affiliation': ''}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ikawa', 'Affiliation': ''}, {'ForeName': 'Rie', 'Initials': 'R', 'LastName': 'Nakae', 'Affiliation': ''}, {'ForeName': 'Fumihiro', 'Initials': 'F', 'LastName': 'Ochi', 'Affiliation': ''}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Tokuda', 'Affiliation': ''}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Akagami', 'Affiliation': ''}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Murai', 'Affiliation': ''}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Miuchi', 'Affiliation': ''}, {'ForeName': 'Tomoya', 'Initials': 'T', 'LastName': 'Hamaguchi', 'Affiliation': ''}, {'ForeName': 'Jun-Ichiro', 'Initials': 'J', 'LastName': 'Miyagawa', 'Affiliation': ''}, {'ForeName': 'Mitsuyoshi', 'Initials': 'M', 'LastName': 'Namba', 'Affiliation': ''}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-013-0048-5'] 504,24604395,Efficacy and Safety of Vildagliptin as Add-on to Metformin in Japanese Patients with Type 2 Diabetes Mellitus.,"INTRODUCTION The objective of this study was to evaluate the efficacy and safety of vildagliptin, a potent dipeptidyl peptidase-4 inhibitor, as an add-on to metformin in Japanese patients with type 2 diabetes mellitus (T2DM). METHODS This multicenter, 12-week, randomized, double-blind, placebo-controlled, parallel-arm study compared vildagliptin 50 mg bid with placebo in T2DM patients who were inadequately controlled [glycosylated hemoglobin (HbA1c) 7.0-10.0%] on a stable daily dose of metformin monotherapy (250 mg bid or 500 mg bid). RESULTS A total of 139 patients were randomized to receive either vildagliptin (n = 69) or placebo (n = 70). Patient demographics were comparable between the groups at baseline. After 12 weeks of treatment, adjusted mean change in HbA1c was -1.1% in the vildagliptin group (baseline 8.0%) and -0.1% in the placebo group (baseline 8.0%), with a between-treatment difference of -1.0% (P < 0.001). Vildagliptin showed a similar reduction in HbA1c of -1.1% for both the subpopulations of patients receiving metformin 250 mg bid or 500 mg bid (P < 0.001 vs. baseline). Significantly more patients in the vildagliptin group achieved an HbA1c target of ≤6.5% (30.9%) and <7.0% (64.1%) compared with the placebo group (P < 0.001). The between-treatment difference in adjusted mean change in fasting plasma glucose was -1.6 mmol/L (P < 0.001) in favor of vildagliptin. Patients in the vildagliptin and placebo groups reported comparable incidences of adverse events (44.1% vs. 41.4%). No deaths or hypoglycemic events were reported in the study. CONCLUSIONS Vildagliptin 50 mg bid added to metformin improved glycemic control without any tolerability issues and hypoglycemia in Japanese patients with T2DM inadequately controlled on metformin monotherapy.",2014,Vildagliptin showed a similar reduction in HbA1c of -1.1% for both the subpopulations of patients receiving metformin 250 mg bid or 500 mg bid (P < 0.001 vs. baseline).,"['Japanese Patients with Type 2 Diabetes Mellitus', 'Japanese patients with T2DM inadequately controlled on metformin monotherapy', 'A total of 139 patients', 'Japanese patients with type 2 diabetes mellitus (T2DM', 'T2DM patients who were inadequately controlled [glycosylated hemoglobin (HbA1c) 7.0-10.0%] on a stable daily dose of']","['placebo', 'metformin', 'vildagliptin 50', 'Vildagliptin', 'Metformin', 'vildagliptin', 'metformin monotherapy', 'vildagliptin and placebo']","['fasting plasma glucose', 'tolerability issues and hypoglycemia', 'efficacy and safety', 'deaths or hypoglycemic events', 'mean change in HbA1c', 'Efficacy and Safety', 'adverse events']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1570906', 'cui_str': 'vildagliptin'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",139.0,0.0632727,Vildagliptin showed a similar reduction in HbA1c of -1.1% for both the subpopulations of patients receiving metformin 250 mg bid or 500 mg bid (P < 0.001 vs. baseline).,"[{'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Odawara', 'Affiliation': 'The Third Department of Internal Medicine, Tokyo Medical University, Tokyo, Japan, odawara@tokyo-med.ac.jp.'}, {'ForeName': 'Izumi', 'Initials': 'I', 'LastName': 'Hamada', 'Affiliation': ''}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Suzuki', 'Affiliation': ''}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-014-0059-x'] 505,24510375,Albiglutide Does Not Prolong QTc Interval in Healthy Subjects: A Thorough ECG Study.,"INTRODUCTION Albiglutide, a selective once-weekly glucagon-like peptide-1 receptor agonist, is being developed for the treatment of type 2 diabetes mellitus. Albiglutide's effect on cardiac repolarization (QTc interval) was assessed in a randomized, double-blind, placebo-controlled, parallel-group study in healthy subjects with a nested crossover comparison for moxifloxacin. METHODS Subjects were randomized to albiglutide (n = 85) or placebo (n = 89) and received injections of 30 mg albiglutide or placebo on Days 1 and 8 and 50 mg albiglutide or placebo on Days 15, 22, 29, and 36. In the placebo group, moxifloxacin was administered on Day -1 in half the subjects and on Day 40 in the other half. Blood samples for albiglutide plasma concentration were drawn on Days 4 and 39 and serial ECGs were extracted from continuous recordings on Days -2 (baseline), -1, 4, 39, and 40. RESULTS Demographics were generally similar between albiglutide and placebo subjects: mean age was 29 years and BMI 25 kg/m(2). Mean change-from-baseline QTcI (∆QTcI, which was corrected for individual heart rate) on Day 4 after a single dose of albiglutide 30 mg and on Day 39 after repeat dosing with albiglutide 50 mg once weekly was similar to the placebo response. The placebo-corrected ΔQTcI (ΔΔQTcI) on both albiglutide doses was small with the largest ΔΔQTcI of 1.1 ms (upper bound of 90% CI 3.8 ms) on Day 4 and -0.6 ms (upper bound of CI 1.8 ms) on Day 39. Moxifloxacin caused the largest mean effect on ΔΔQTcI of 10.9 ms and the lower bound of the CI was above 5 ms at all preselected timepoints, thereby demonstrating assay sensitivity. Albiglutide was well tolerated and there were no clinically relevant differences in safety data between albiglutide and placebo. CONCLUSION Albiglutide at doses up to 50 mg in healthy subjects did not prolong the QTc interval.",2014,"Albiglutide was well tolerated and there were no clinically relevant differences in safety data between albiglutide and placebo. ","['Healthy Subjects', 'Subjects were randomized to albiglutide (n\xa0=\xa085) or', 'healthy subjects with a nested crossover comparison for']","['placebo-corrected ΔQTcI (ΔΔQTcI', 'placebo', 'injections of 30\xa0mg albiglutide or placebo on Days 1 and 8 and 50\xa0mg albiglutide or placebo', 'moxifloxacin', 'Moxifloxacin']","['cardiac repolarization (QTc interval', 'QTc interval', 'ΔΔQTcI']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C2607479', 'cui_str': 'albiglutide'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C2607479', 'cui_str': 'albiglutide'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}]","[{'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",,0.276857,"Albiglutide was well tolerated and there were no clinically relevant differences in safety data between albiglutide and placebo. ","[{'ForeName': 'Borje', 'Initials': 'B', 'LastName': 'Darpo', 'Affiliation': ""Department of Clinical Sciences, Karolinska Institute, Division of Cardiovascular Medicine, Danderyd's Hospital, Stockholm, Sweden, borje.darpo@telia.com.""}, {'ForeName': 'Meijian', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Matthews', 'Affiliation': ''}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhi', 'Affiliation': ''}, {'ForeName': 'Malcolm A', 'Initials': 'MA', 'LastName': 'Young', 'Affiliation': ''}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Perry', 'Affiliation': ''}, {'ForeName': 'Rickey R', 'Initials': 'RR', 'LastName': 'Reinhardt', 'Affiliation': ''}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-014-0055-1'] 506,24984785,"Results from a pooled analysis of two European, randomized, placebo-controlled, phase 3 studies of ATX-101 for the pharmacologic reduction of excess submental fat.","BACKGROUND The injectable adipocytolytic drug ATX-101 is the first nonsurgical treatment for the reduction of submental fat (SMF) to undergo comprehensive clinical evaluation. This study aimed to confirm the efficacy and safety of ATX-101 for SMF reduction through a post hoc pooled analysis of two large phase 3 studies. METHODS Patients with unwanted SMF were randomized to receive 1 or 2 mg/cm(2) of ATX-101 or a placebo injected into their SMF during a maximum of four treatment sessions spaced approximately 28 days apart, with a 12-week follow-up period. The proportions of patients with reductions in SMF of one point or more on the Clinician-Reported SMF Rating Scale (CR-SMFRS) and the proportions of patients satisfied with the appearance of their face and chin [Subject Self-Rating Scale (SSRS) score ≥4] were reported overall and in subgroups. Other efficacy measures included improvements in the Patient-Reported SMF Rating Scale (PR-SMFRS), calliper measurements of SMF thickness, and assessment of skin laxity [Skin Laxity Rating Scale (SLRS)]. Adverse events and laboratory test results were recorded. RESULTS Significantly greater proportions of the patients had improvements in clinician-reported measures (≥1-point improvement in CR-SMFRS: 58.8 and 63.8 % of the patients who received ATX-101 1 and 2 mg/cm(2), respectively, and 28.6 % of the placebo recipients; p < 0.001 for both ATX-101 doses vs. placebo) and patient-reported measures (≥1-point improvement in PR-SMFRS: 60.0 and 63.1 % of the patients who received ATX-101 1 and 2 mg/cm(2), respectively, vs. 34.3 % of the placebo recipients; p < 0.001 for both), analyzed alone or in combination, with ATX-101 versus placebo. These improvements correlated moderately with patient satisfaction regarding face and chin appearance (SSRS score ≥4: 60.8 and 65.4 % of the patients who received ATX-101 1 and 2 mg/cm(2), respectively, vs. 29.0 % of the placebo recipients; p < 0.001 for both). In this study, ATX-101 was effective irrespective of gender, age, or body mass index. Reduction in SMF with ATX-101 was confirmed by calliper measurements (p < 0.001 for both doses vs. placebo) and generally did not lead to worsening of skin laxity (SLRS improved or was unchanged: 91.3 and 90.5 % of the patients who received ATX-101 1 and 2 mg/cm(2), respectively, and 91.6 % of the placebo recipients). Adverse events were mostly transient, mild to moderate in intensity, and localized to the treatment area. CONCLUSION The findings show ATX-101 to be an effective and well-tolerated pharmacologic treatment for SMF reduction.",2014,"Reduction in SMF with ATX-101 was confirmed by calliper measurements (p < 0.001 for both doses vs. placebo) and generally did not lead to worsening of skin laxity (SLRS improved or was unchanged: 91.3 and 90.5 % of the patients who received ATX-101 1 and 2 mg/cm(2), respectively, and 91.6 % of the placebo recipients).",['Patients with unwanted SMF'],"['placebo', 'ATX-101 or a placebo', 'ATX-101']","['patient satisfaction regarding face and chin appearance', 'Adverse events', 'SMF Rating Scale (CR-SMFRS', 'SMF Rating Scale (PR-SMFRS), calliper measurements of SMF thickness, and assessment of skin laxity [Skin Laxity Rating Scale (SLRS', 'PR-SMFRS', 'appearance of their face and chin [Subject Self-Rating Scale (SSRS) score ≥4', 'worsening of skin laxity (SLRS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0008114', 'cui_str': 'Mentum'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0222045'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0010495', 'cui_str': 'Dermatolysis'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}]",,0.149745,"Reduction in SMF with ATX-101 was confirmed by calliper measurements (p < 0.001 for both doses vs. placebo) and generally did not lead to worsening of skin laxity (SLRS improved or was unchanged: 91.3 and 90.5 % of the patients who received ATX-101 1 and 2 mg/cm(2), respectively, and 91.6 % of the placebo recipients).","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'McDiarmid', 'Affiliation': 'McDiarmid-Hall Clinic, Derriford, Plymouth, UK.'}, {'ForeName': 'Jesus Benito', 'Initials': 'JB', 'LastName': 'Ruiz', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Lippert', 'Affiliation': ''}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Hartisch', 'Affiliation': ''}, {'ForeName': 'Blanka', 'Initials': 'B', 'LastName': 'Havlickova', 'Affiliation': ''}]",Aesthetic plastic surgery,['10.1007/s00266-014-0364-9'] 507,24371021,Methylphenidate hydrochloride modified-release in adults with attention deficit hyperactivity disorder: a randomized double-blind placebo-controlled trial.,"INTRODUCTION Treatment options for adults with attention deficit hyperactivity disorder (ADHD) are limited. The study was conducted to confirm the clinically effective and safe dose of methylphenidate hydrochloride modified-release (MPH-LA) in adults with ADHD and evaluate the maintenance of effect of MPH-LA. METHODS The study consisted of three treatment phases. The double-blind dose-confirmation phase: 9-week double-blind period (3-week titration period, 6-week fixed dose) with randomization to MPH-LA 40, 60, or 80 mg/day or placebo. The real-life dose-optimization phase: a 5-week re-titration period to optimal dose; and the double-blind maintenance of effect phase, a 6-month double-blind randomized placebo-controlled maintenance of effect phase. The three co-primary endpoints were change in Diagnostic and Statistical Manual of Mental Disorders-IV ADHD Rating Scale (DSM-IV ADHD RS) and Sheehan Disability Scale (SDS) total scores from baseline to end of 9-week confirmation phase and the percentage of treatment failures during the 6-month maintenance of effect phase. RESULTS 725 of 863 screened patients were randomized to 40 (N = 181), 60 (N = 182), or 80 mg (N = 181) MPH-LA or placebo (N = 181), and 584 (80.6%) completed. 489 (83.7%) of completers were re-randomized to the double-blinded maintenance of effect phase and 235 (48.1%) of them completed. Improvement from baseline in DSM-IV ADHD RS (P < 0.0001 for all comparisons) and SDS (40 mg, P = 0.0003; 60 mg, P = 0.0176; 80 mg, P < 0.0001) total scores was significantly greater vs. placebo for all MPH-LA doses. Treatment failure rate was significantly lower with MPH-LA (21.3%) versus placebo (49.6%) during the 6-month maintenance of effect phase. Safety profile was consistent with the profile for MPH-LA in children; percentage of serious adverse events was comparable between all MPH-LA arms (1.3%) and placebo (1.5%), while percentage of adverse events was higher in MPH-LA arms. CONCLUSION MPH-LA provided and maintained significant symptomatic and functional improvement in adult ADHD patients.",2014,Treatment failure rate was significantly lower with MPH-LA (21.3%) versus placebo (49.6%) during the 6-month maintenance of effect phase.,"['adults with attention deficit hyperactivity disorder (ADHD', 'adults with ADHD', 'adult ADHD patients', '725 of 863 screened patients', 'adults with attention deficit hyperactivity disorder']","['MPH-LA', 'placebo', 'Methylphenidate hydrochloride', 'methylphenidate hydrochloride modified-release (MPH-LA', 'MPH-LA or placebo']","['total scores', 'DSM-IV ADHD RS (P', 'serious adverse events', 'change in Diagnostic and Statistical Manual of Mental Disorders-IV ADHD Rating Scale (DSM-IV ADHD RS) and Sheehan Disability Scale (SDS) total scores', 'adverse events', 'Treatment failure rate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0700545', 'cui_str': 'Methylphenidate Hydrochloride'}, {'cui': 'C4544813', 'cui_str': 'Modified-release'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0222045'}, {'cui': 'C4720840', 'cui_str': 'Sheehan disability scale'}, {'cui': 'C0162643'}]",863.0,0.42517,Treatment failure rate was significantly lower with MPH-LA (21.3%) versus placebo (49.6%) during the 6-month maintenance of effect phase.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Huss', 'Affiliation': 'Child and Adolescent Psychiatry, University of Medicine, Mainz, Germany, michael.huss@unimedizin-mainz.de.'}, {'ForeName': 'Ylva', 'Initials': 'Y', 'LastName': 'Ginsberg', 'Affiliation': ''}, {'ForeName': 'Torbjorn', 'Initials': 'T', 'LastName': 'Tvedten', 'Affiliation': ''}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Arngrim', 'Affiliation': ''}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Philipsen', 'Affiliation': ''}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Carter', 'Affiliation': ''}, {'ForeName': 'Chien-Wei', 'Initials': 'CW', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Vinod', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': ''}]",Advances in therapy,['10.1007/s12325-013-0085-5'] 508,24163113,"Dipeptidyl peptidase-4 inhibition in patients with type 2 diabetes treated with saxagliptin, sitagliptin, or vildagliptin.","INTRODUCTION Saxagliptin, sitagliptin, and vildagliptin are dipeptidyl peptidase-4 (DPP-4) inhibitors widely approved for use in patients with type 2 diabetes. Using a crossover design, the present study compared trough levels of DPP-4 inhibition provided by these agents in a single cohort of patients with type 2 diabetes. METHODS This was a randomized, placebo-controlled, open-label, five-period crossover study. Eligible patients were 18-65 years of age, either treatment-naïve or off prior antihyperglycemic agent therapy for at least 6 or 12 weeks (depending on the prior therapy), and had glycated hemoglobin (HbA1C) ≥6.5% and ≤10.0%. In separate study periods, patients received 5 mg saxagliptin q.d. (saxa-5), 100 mg sitagliptin q.d. (sita-100), 50 mg vildagliptin q.d. (vilda-50-q.d.), 50 mg vildagliptin b.i.d. (vilda-50-b.i.d.), or placebo for 5 days. The primary endpoint was trough %DPP-4 inhibition, derived by comparing DPP-4 activity 24 h after the Day-5 morning dose with predose activity in the same period and analyzed using a linear mixed-effects model with fixed-effects terms for treatment and period. RESULTS Mean (range) baseline HbA1C was 7.4% (6.4-9.0%; N = 22). Least-squares (LS) mean trough %DPP-4 inhibition was 73.5%, 91.7%, 28.9%, 90.6%, and 3.5% after saxa-5, sita-100, vilda-50-q.d., vilda-50-b.i.d., and placebo, respectively. In patients treated with sita-100, the LS-mean difference in trough %DPP-4 inhibition was 18.2% greater than with saxa-5 (p < 0.001), 62.9% greater than with vilda-50-q.d. (p < 0.001), 1.1% greater than with vilda-50-b.i.d. (p = 0.128), and 87.8% greater than with placebo (p < 0.001). Mean %DPP-4 inhibition was nearly maximal at 12 h postdose regardless of active treatment. Thus, these between-group comparisons at trough primarily reflected differences in duration of action. Adverse events reported during the study were transient and mild or moderate in intensity. CONCLUSION Once daily treatment with sitagliptin provided trough DPP-4 inhibition significantly greater than saxagliptin or vildagliptin administered once daily, and similar to that provided by vildagliptin administered twice daily.",2013,"Once daily treatment with sitagliptin provided trough DPP-4 inhibition significantly greater than saxagliptin or vildagliptin administered once daily, and similar to that provided by vildagliptin administered twice daily.","['Eligible patients were 18-65\xa0years of age, either treatment-naïve or off prior antihyperglycemic agent therapy for at least 6 or 12\xa0weeks (depending on the prior therapy), and had glycated hemoglobin (HbA1C) ≥6.5% and ≤10.0', 'patients with type 2 diabetes', 'patients with type 2 diabetes treated with']","['saxagliptin, sitagliptin, or vildagliptin', 'placebo', 'Saxagliptin, sitagliptin, and vildagliptin are dipeptidyl peptidase-4 (DPP-4) inhibitors', 'Dipeptidyl peptidase-4 inhibition', 'vildagliptin', 'saxagliptin', 'saxagliptin or vildagliptin']","['trough DPP-4 inhibition', 'Least-squares (LS) mean trough %DPP-4 inhibition', 'Adverse events', 'trough %DPP-4 inhibition', 'duration of action', 'Mean %DPP-4 inhibition', 'Mean (range) baseline HbA1C']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1611934', 'cui_str': 'saxagliptin'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C1570906', 'cui_str': 'vildagliptin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3653297', 'cui_str': 'Dipeptidyl peptidase 4 (DPP-4) inhibitors'}, {'cui': 'C0081937', 'cui_str': 'Dipeptidyl-Peptidase IV'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}]",,0.158946,"Once daily treatment with sitagliptin provided trough DPP-4 inhibition significantly greater than saxagliptin or vildagliptin administered once daily, and similar to that provided by vildagliptin administered twice daily.","[{'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Tatosian', 'Affiliation': 'Merck & Co., Inc., One Merck Drive, P.O. Box 100, Whitehouse Station, NJ, 08889-0100, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Schaeffer', 'Affiliation': ''}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Gaibu', 'Affiliation': ''}, {'ForeName': 'Serghei', 'Initials': 'S', 'LastName': 'Popa', 'Affiliation': ''}, {'ForeName': 'Aubrey', 'Initials': 'A', 'LastName': 'Stoch', 'Affiliation': ''}, {'ForeName': 'Ronald B', 'Initials': 'RB', 'LastName': 'Langdon', 'Affiliation': ''}, {'ForeName': 'Eunkyung A', 'Initials': 'EA', 'LastName': 'Kauh', 'Affiliation': ''}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-013-0045-8'] 509,24072665,OnabotulinumtoxinA is effective in patients with urinary incontinence due to neurogenic detrusor overactivity [corrected] regardless of concomitant anticholinergic use or neurologic etiology.,"INTRODUCTION To evaluate the efficacy and safety of onabotulinumtoxinA for the treatment of neurogenic detrusor overactivity (NDO) in subpopulations of etiology (multiple sclerosis [MS] or spinal cord injury [SCI]) and concomitant anticholinergics (use/non-use). METHODS Data were pooled from two double-blind, placebo-controlled, pivotal, phase 3 studies including a total of 691 patients with ≥ 14 urinary incontinence (UI) episodes/week due to MS (n = 381) or SCI (n = 310). Patients received intradetrusor injections of onabotulinumtoxinA 200U (n = 227), 300U (n = 223), or placebo (n = 241). Change from baseline at week 6 in UI episodes/week (primary endpoint), urodynamics, quality of life (QOL), and adverse events (AEs) were assessed. RESULTS Significant and similar reductions in UI episodes were observed regardless of etiology or anticholinergic use: at week 6, mean weekly decreases of -22.6 and -19.6 were seen in MS and SCI patients, respectively, and -20.3 and -22.5 in anticholinergic users and non-users, respectively, treated with onabotulinumtoxinA 200U. The 300U dose did not add to the clinical efficacy in any subpopulation. Similar proportions of patients achieved ≥ 50% or 100% reductions in UI episodes in all subgroups. Improvements in maximum cystometric capacity, maximum detrusor pressure during first involuntary detrusor contraction, and QOL were significant in both etiologies and were independent of anticholinergic use. The most common AEs in all groups were urinary tract infection and urinary retention. CONCLUSION Regardless of concomitant anticholinergic use or etiology, onabotulinumtoxinA significantly improved UI symptoms, urodynamics, and QOL in patients with UI due to NDO. OnabotulinumtoxinA was well tolerated in all groups.",2013,"RESULTS Significant and similar reductions in UI episodes were observed regardless of etiology or anticholinergic use: at week 6, mean weekly decreases of -22.6","['patients with UI due to NDO', 'controlled, pivotal, phase 3 studies including a total of 691 patients with ≥ 14 urinary incontinence (UI) episodes/week due to MS (n = 381) or SCI (n = 310', 'patients with urinary incontinence']","['onabotulinumtoxinA', 'OnabotulinumtoxinA', 'placebo']","['maximum cystometric capacity, maximum detrusor pressure during first involuntary detrusor contraction, and QOL', 'efficacy and safety', 'urodynamics, quality of life (QOL), and adverse events (AEs', 'UI symptoms, urodynamics, and QOL', 'urinary tract infection and urinary retention']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4708787', 'cui_str': '381 (qualifier value)'}]","[{'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0429809', 'cui_str': 'Maximum cystometric capacity (observable entity)'}, {'cui': 'C0429766', 'cui_str': 'Detrusor pressure (observable entity)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C0034380'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0080274', 'cui_str': 'Urinary Retention'}]",691.0,0.0354033,"RESULTS Significant and similar reductions in UI episodes were observed regardless of etiology or anticholinergic use: at week 6, mean weekly decreases of -22.6","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ginsberg', 'Affiliation': 'Department of Urology, University of Southern California Institute of Urology, 1441 Eastlake Avenue, NOR 7416, Los Angeles, CA, 90033-9178, USA, ginsberg@ccnt.usc.edu.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Cruz', 'Affiliation': ''}, {'ForeName': 'Sender', 'Initials': 'S', 'LastName': 'Herschorn', 'Affiliation': ''}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Gousse', 'Affiliation': ''}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Keppenne', 'Affiliation': ''}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Aliotta', 'Affiliation': ''}, {'ForeName': 'Karl-Dietrich', 'Initials': 'KD', 'LastName': 'Sievert', 'Affiliation': ''}, {'ForeName': 'Mitchell F', 'Initials': 'MF', 'LastName': 'Brin', 'Affiliation': ''}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Jenkins', 'Affiliation': ''}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Thompson', 'Affiliation': ''}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Lam', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Heesakkers', 'Affiliation': ''}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Haag-Molkenteller', 'Affiliation': ''}]",Advances in therapy,['10.1007/s12325-013-0054-z'] 510,24062147,Dose-finding study of landiolol hydrochloride: a short-acting β1-blocker for controlling heart rate during coronary computed-tomography angiography in Japan.,"INTRODUCTION Coronary computed-tomography angiography (CCTA) has high diagnostic performance, but it sometimes does not allow evaluation because of artifacts. Currently, the use of a β-blocker is recommended to prevent motion artifacts, but the β-blocker (metoprolol, propranolol, etc.) commonly used has a slow onset and long duration of action. Landiolol hydrochloride is an intravenous β1-blocker with a very short half-life. We investigated the efficacy and optimal dose of this drug for reduction of heart rate in patients undergoing CCTA. METHODS Eighty-seven subjects with ischemic heart disease were divided into three groups to receive landiolol hydrochloride at a dose of 0.125 (Group L), 0.25 (Group M), or 0.5 mg/kg (Group H). CCTA was performed at 3-7 min after administration, and heart rate, blood pressure, and image quality were assessed. RESULTS Heart rate decreased rapidly after completion of landiolol hydrochloride administration in all groups, with a heart rate reduction of 15.55 ± 6.56% in Group L, 16.48 ± 7.80% in Group M, and 21.49 ± 6.13% in Group H (Group L vs Group H, P = 0.0008; Group M vs Group H, P = 0.0109). Since there was no significant difference in heart rate during imaging among the three groups, although there was a significant difference between groups L and H and groups M and H in terms of percent change in heart rate, coronary stenosis was diagnosable in all groups with no significant difference. CONCLUSION Landiolol hydrochloride showed a rapid onset and short β-blocking effect, and was most effective at a dose of 0.5 mg/kg. However, the diagnosable proportion had no significant differences among the three groups in CCTA. Therefore, the clinically recommended dose was 0.125 mg/kg or less, considering the heart rate of patients with suspected coronary stenosis during CCTA.",2013,"Since there was no significant difference in heart rate during imaging among the three groups, although there was a significant difference between groups L and H and groups M and H in terms of percent change in heart rate, coronary stenosis was diagnosable in all groups with no significant difference. ","['Japan', 'Eighty-seven subjects with ischemic heart disease', 'patients undergoing CCTA']","['Landiolol hydrochloride', 'Coronary computed-tomography angiography (CCTA', 'CCTA', 'landiolol hydrochloride']","['Heart rate', 'heart rate, blood pressure, and image quality', 'heart rate', 'rapid onset and short β-blocking effect', 'heart rate reduction', 'heart rate, coronary stenosis']","[{'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C4517895', 'cui_str': 'Eighty-seven'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0905464', 'cui_str': 'landiolol'}, {'cui': 'C1536105', 'cui_str': 'Angiography, CT'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0242231', 'cui_str': 'Coronary Artery Stenosis'}]",87.0,0.0364789,"Since there was no significant difference in heart rate during imaging among the three groups, although there was a significant difference between groups L and H and groups M and H in terms of percent change in heart rate, coronary stenosis was diagnosable in all groups with no significant difference. ","[{'ForeName': 'Masaharu', 'Initials': 'M', 'LastName': 'Hirano', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, 6-7-1, Nishi-shinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan, m-hirano@tokyo-med.ac.jp.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Hara', 'Affiliation': ''}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Ikari', 'Affiliation': ''}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Jinzaki', 'Affiliation': ''}, {'ForeName': 'Misako', 'Initials': 'M', 'LastName': 'Iino', 'Affiliation': ''}, {'ForeName': 'Chikuma', 'Initials': 'C', 'LastName': 'Hamada', 'Affiliation': ''}, {'ForeName': 'Sachio', 'Initials': 'S', 'LastName': 'Kuribayashi', 'Affiliation': ''}]",Advances in therapy,['10.1007/s12325-013-0053-0'] 511,23870044,"Effect of conjugated linoleic acid and vitamin E on glycemic control, body composition, and inflammatory markers in overweight type2 diabetics.","BACKGROUND The healthy properties of conjugated linoleic acid (CLA) such as weight loss, reducing cardiovascular risk factors and inflammation have been reported. The trans-10, cis-12 CLA isomer is related to increasing insulin resistance, but the effects of cis-9, trans-11 isomer is not clear. The aim of this study was to investigate the effects of CLA with and without Vitamin E on body weight, body composition, glycemic index, inflammatory and coagulation factors, lipid profile, serum leptin and adiponectin, malondialdehyde (MDA), and blood pressure in type2 diabetes. METHODS 56 patients with type2 diabetes were included in 8 week double-blind control trial that used metformin. They randomly divided into three groups: CLA + VitE, CLA + VitE placebo, CLA placebo + VitE placebo. All variables, anthropometric measurements, and body composition were evaluated at the beginning and the end of study. Statistical analysis and analysis of dietary data were performed using SPSS and nutritionist IV software, respectively. RESULTS There were not any significant differences in variable changes among three groups. However, there was a trend to increase in MDA and decrease in apoB100 among CLA consumers. CONCLUSION The results of this study showed that administration of CLA supplementation for 8 weeks does not affect any indicators of metabolic control in overweight type2 diabetic patients.",2013,There were not any significant differences in variable changes among three groups.,"['overweight type2 diabetics', '56 patients with type2 diabetes', 'overweight type2 diabetic patients']","['metformin', 'conjugated linoleic acid and vitamin E', 'conjugated linoleic acid (CLA', 'CLA with and without Vitamin E', 'CLA supplementation', 'CLA + VitE, CLA + VitE placebo, CLA placebo + VitE placebo']","['MDA', 'metabolic control', 'body weight, body composition, glycemic index, inflammatory and coagulation factors, lipid profile, serum leptin and adiponectin, malondialdehyde (MDA), and blood pressure', 'glycemic control, body composition, and inflammatory markers', 'anthropometric measurements, and body composition']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1257880', 'cui_str': 'Linoleic Acids, Conjugated'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C1167912', 'cui_str': 'Coagulation factor assay'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",56.0,0.128001,There were not any significant differences in variable changes among three groups.,"[{'ForeName': 'Zhaleh', 'Initials': 'Z', 'LastName': 'Shadman', 'Affiliation': 'Cellular and Molecular Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Hedayati@endocrine.ac.ir.'}, {'ForeName': 'Forough Azam', 'Initials': 'FA', 'LastName': 'Taleban', 'Affiliation': ''}, {'ForeName': 'Navid', 'Initials': 'N', 'LastName': 'Saadat', 'Affiliation': ''}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hedayati', 'Affiliation': ''}]",Journal of diabetes and metabolic disorders,['10.1186/2251-6581-12-42'] 512,23939394,Downregulation of CPPED1 expression improves glucose metabolism in vitro in adipocytes.,"We have previously demonstrated that the expression of calcineurin-like phosphoesterase domain containing 1 (CPPED1) decreases in adipose tissue (AT) after weight reduction. However, the function of CPPED1 in AT is unknown. Therefore, we investigated whether the change in CPPED1 expression is connected to changes in adipocyte glucose metabolism. First, we confirmed that the expression of CPPED1 decreased after weight loss in subcutaneous AT. Second, the expression of CPPED1 did not change during adipocyte differentiation. Third, CPPED1 knockdown with small interfering RNA increased expression of genes involved in glucose metabolism (adiponectin, adiponectin receptor 1, and GLUT4) and improved insulin-stimulated glucose uptake. To conclude, CPPED1 is a novel molecule involved in AT biology, and CPPED1 is involved in glucose uptake in adipocytes.",2013,"Third, CPPED1 knockdown with small interfering RNA increased expression of genes involved in glucose metabolism (adiponectin, adiponectin receptor 1, and GLUT4) and improved insulin-stimulated glucose uptake.",[],['CPPED1'],"['glucose metabolism (adiponectin, adiponectin receptor 1, and GLUT4) and improved insulin-stimulated glucose uptake']",[],[],"[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C1955918', 'cui_str': 'Receptors, Adiponectin'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]",,0.0257622,"Third, CPPED1 knockdown with small interfering RNA increased expression of genes involved in glucose metabolism (adiponectin, adiponectin receptor 1, and GLUT4) and improved insulin-stimulated glucose uptake.","[{'ForeName': 'Maija', 'Initials': 'M', 'LastName': 'Vaittinen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, Department of Clinical Nutrition, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Kaminska', 'Affiliation': ''}, {'ForeName': 'Pirjo', 'Initials': 'P', 'LastName': 'Käkelä', 'Affiliation': ''}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Eskelinen', 'Affiliation': ''}, {'ForeName': 'Marjukka', 'Initials': 'M', 'LastName': 'Kolehmainen', 'Affiliation': ''}, {'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Pihlajamäki', 'Affiliation': ''}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Uusitupa', 'Affiliation': ''}, {'ForeName': 'Leena', 'Initials': 'L', 'LastName': 'Pulkkinen', 'Affiliation': ''}]",Diabetes,['10.2337/db13-0830'] 513,23888255,Clinical efficacy of a cosmetic treatment by Crescina(®) human follicle stem cell on healthy males with androgenetic alopecia.,"INTRODUCTION Androgenetic alopecia (AGA) is the most common cause of hair loss among males, characterized by progressive thinning of the scalp hairs and defined by various patterns. The main factors underling hair loss in AGA are genetic predisposition and increased sensitivity of the hair follicles to androgens, leading to a shortening of the anagen phase. In the present study, the authors investigated the efficacy of a commercially available cosmetic lotion, Crescina(®) HFSC (human follicle stem cell; Labo Cosprophar AG, Basel, Switzerland), in promoting hair growth and in decreasing hair loss. METHODS A placebo-controlled, randomized trial was carried out on healthy males suffering from alopecia grade II to IV. Anagen rate and hair resistance to traction (pull test) were assessed after 2 and 4 months of treatment using phototricogram and pull test technique. RESULTS Crescina(®) HFSC applied for 4 months was effective in promoting hair growth and in decreasing hair loss. After 2 and 4 months of treatment, the anagen rate was increased by 29.6% and 46.8%, respectively [corrected]. Hair resistance to traction was decreased by 29.6% and 46.8%, respectively. CONCLUSIONS The present study demonstrated the positive effect of Crescina(®) HFSC in modulating the activity of the hair follicle and promoting hair growth.",2013,"Hair resistance to traction was decreased by 29.6% and 46.8%, respectively. ","['healthy males suffering from alopecia grade II to IV', 'healthy males with androgenetic alopecia']","['commercially available cosmetic lotion, Crescina(®) HFSC', 'placebo', 'Crescina(®', 'cosmetic treatment by Crescina(®) human follicle stem cell', 'Crescina(®) HFSC', 'HFSC']","['hair loss', 'hair growth', 'Anagen rate and hair resistance to traction (pull test', 'Hair resistance to traction', 'anagen rate']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0162311', 'cui_str': 'Pattern Baldness'}]","[{'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C0544341', 'cui_str': 'Lotion (basic dose form)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}]","[{'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0232407', 'cui_str': 'Hair growth, function (observable entity)'}, {'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0040597', 'cui_str': 'Traction'}, {'cui': 'C0580846', 'cui_str': 'Does pull (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",,0.0405425,"Hair resistance to traction was decreased by 29.6% and 46.8%, respectively. ","[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Buonocore', 'Affiliation': 'Laboratory of Pharmaco-Biochemistry, Nutrition and Nutraceutical of Wellness, Department of Biology and Biotechnology ""L. Spallanzani,"", University of Pavia, via Ferrata 9, 27100 Pavia, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Nobile', 'Affiliation': ''}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Michelotti', 'Affiliation': ''}, {'ForeName': 'Fulvio', 'Initials': 'F', 'LastName': 'Marzatico', 'Affiliation': ''}]",Dermatology and therapy,['10.1007/s13555-013-0021-2'] 514,23888258,A new minimally invasive mesotherapy technique for facial rejuvenation.,"INTRODUCTION This study describes a pivotal clinical trial of a new minimally invasive mesotherapy technique for facial rejuvenation. METHODS The authors utilized two formulations: formulation A with hyaluronic acid, vitamins, amino acids, minerals, coenzymes, and antioxidant substances; formulation B with hyaluronic acid and idebenone. Fifty participants were enrolled in the study and divided in two groups. Group 1 (50-65 years) treated with formulation A. Group 2 (35-50 years) treated with formulation B. The groups underwent four sessions of mesotherapy involving multiple injections. Treatment was conducted at 15 day intervals. All participants had pre- and posttreatment photographs. Punch biopsies were taken from randomly selected participants, baseline and after 6 weeks, and stained for interleukin (IL)-6, IL-1β, matrix metalloproteinase (MMP)-1, and collagen 1. Clinical evaluation was based on the Global Aesthetic Scale (GAIS) and on the Wrinkle Severity Rating Scale (WSRS). RESULTS The results produced were statistically analyzed and resulted in a significant and long-lasting effect on facial rejuvenation. Evaluation of photographs at 0, 1, and 2 months revealed significant clinical improvement: brightness, texture, and firmness of the skin. The analysis of the GAIS and WSRS scores in the two groups demonstrated statistically significant results after 2 months. The biopsies taken from randomly selected participants at baseline and after 3 months showed a decrease in IL-1β, IL-6, and MMP1, and an increase in collagen 1. CONCLUSION The new minimally invasive mesotherapy technique described can improve the clinical appearance of the skin in different age groups.",2013,"Evaluation of photographs at 0, 1, and 2 months revealed significant clinical improvement: brightness, texture, and firmness of the skin.","['Fifty participants were enrolled in the study and divided in two groups', 'facial rejuvenation']","['mesotherapy', 'formulation B', 'hyaluronic acid, vitamins, amino acids, minerals, coenzymes, and antioxidant substances; formulation B with hyaluronic acid and idebenone']","['IL-1β, IL-6, and MMP1, and an increase in collagen 1', 'Global Aesthetic Scale (GAIS) and on the Wrinkle Severity Rating Scale (WSRS', 'facial rejuvenation', 'clinical improvement: brightness, texture, and firmness of the skin', 'GAIS and WSRS scores']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0035016', 'cui_str': 'Rejuvenation'}]","[{'cui': 'C2242515', 'cui_str': 'Mesotherapy'}, {'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0009235', 'cui_str': 'Cofactors, Enzyme'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0123163', 'cui_str': 'idebenone'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0222045'}, {'cui': 'C0037301', 'cui_str': 'Skin Wrinkling'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0035016', 'cui_str': 'Rejuvenation'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449582', 'cui_str': 'With texture (attribute)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",50.0,0.0334724,"Evaluation of photographs at 0, 1, and 2 months revealed significant clinical improvement: brightness, texture, and firmness of the skin.","[{'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Savoia', 'Affiliation': 'Promoitalia Group S.p.A, Pozzuoli, Naples Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Landi', 'Affiliation': ''}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Baldi', 'Affiliation': ''}]",Dermatology and therapy,['10.1007/s13555-012-0018-2'] 515,23821355,Experience with vildagliptin in patients ≥75 years with type 2 diabetes and moderate or severe renal impairment.,"INTRODUCTION Patients with type 2 diabetes (T2DM) are at increased risk for renal impairment (RI) and, in addition, there is an age-related decline in renal function. At the same time, T2DM treatment is more complex and treatment options are more limited in elderly patients as well as patients with RI, with the patient population ≥75 years with moderate or severe RI posing unique challenges, in particular, the high risk and more severe consequences of hypoglycemia. It was, therefore, of interest to assess the efficacy and tolerability of the dipeptidyl peptidase-4 inhibitor vildagliptin in patients with T2DM ≥75 years who also have moderate or severe RI. METHODS In this sub-analysis of data derived from a previously described randomized, double-blind, parallel-group, 24-week study, 105 patients (50 randomized to vildagliptin 50 mg qd and 55 to placebo) ≥75 years (mean age ~78 years) with T2DM and moderate or severe RI (mean baseline estimated glomerular filtration rate ~35 ml/min/1.73 m(2)) were included. RESULTS The adjusted mean change in glycated hemoglobin (HbA1c) with vildagliptin was -1.0% from a baseline of 7.8% (between-group difference -0.8%; p < 0.001). This improvement in glycemic control was not associated with an increased risk of hypoglycemia; the rate of confirmed hypoglycemia was 0.49 events per patient-year with vildagliptin and 0.96 events per patient-year with placebo (not significant). Weight remained stable with vildagliptin treatment. Adverse events (AEs) (58.0% vs. 72.7%), serious AEs (14.0% vs. 16.4%), discontinuations due to AEs (4.0% vs. 9.1%) and deaths (0% vs. 5.5%) were reported at a comparable or lower frequency in patients receiving vildagliptin versus patients receiving placebo. CONCLUSION In this uniquely fragile elderly population ≥75 years with T2DM and moderate or severe RI, vildagliptin was well tolerated and efficacious, with no increase in the rate of hypoglycemia compared to placebo despite the marked improvement in glycemic control.",2013,This improvement in glycemic control was not associated with an increased risk of hypoglycemia; the rate of confirmed hypoglycemia was 0.49 events per patient-year with vildagliptin and 0.96 events per patient-year with placebo (not significant).,"['≥75\xa0years (mean age', '105 patients (50 randomized to', 'patients ≥75\xa0years with type 2 diabetes and moderate or severe renal impairment', 'Patients with type 2 diabetes (T2DM', '35', 'patients with T2DM ≥75\xa0years who also have moderate or severe RI']","['vildagliptin', 'dipeptidyl peptidase-4 inhibitor vildagliptin', 'placebo', 'vildagliptin 50\xa0mg\xa0qd and 55 to placebo']","['risk of hypoglycemia; the rate of confirmed hypoglycemia', 'deaths', 'Adverse events (AEs', 'T2DM and moderate or severe RI', 'Weight', 'glycemic control', 'rate of hypoglycemia', 'glycated hemoglobin (HbA1c) with vildagliptin', 'efficacy and tolerability', 'glomerular filtration rate', 'serious AEs']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}]","[{'cui': 'C1570906', 'cui_str': 'vildagliptin'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl-Peptidase 4 Inhibitors'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2240780', 'cui_str': 'vildagliptin 50 MG'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C1570906', 'cui_str': 'vildagliptin'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}]",105.0,0.047094,This improvement in glycemic control was not associated with an increased risk of hypoglycemia; the rate of confirmed hypoglycemia was 0.49 events per patient-year with vildagliptin and 0.96 events per patient-year with placebo (not significant).,"[{'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Schweizer', 'Affiliation': 'Novartis Pharma AG, Postfach, 4002, Basel, Switzerland, anja.schweizer@novartis.com.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Dejager', 'Affiliation': ''}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-013-0027-x'] 516,21881905,Increased variability of motor cortical excitability to transcranial magnetic stimulation in migraine: a new clue to an old enigma.,"Increased, decreased or normal excitability to transcranial magnetic stimulation (TMS) has been reported in the motor (M1) and visual cortices of patients with migraine. Light deprivation (LD) has been reported to modulate M1 excitability in control subjects (CS). Still, effects of LD on M1 excitability compared to exposure to environmental light exposure (EL) had not been previously described in patients with migraine (MP). To further our knowledge about differences between CS and MP, regarding M1 excitability and effects of LD on M1 excitability, we opted for a novel approach by extending measurement conditions. We measured motor thresholds (MTs) to TMS, short-interval intracortical inhibition, and ratios between motor-evoked potential amplitudes and supramaximal M responses in MP and CS on two different days, before and after LD or EL. Motor thresholds significantly increased in MP in LD and EL sessions, and remained stable in CS. There were no significant between-group differences in other measures of TMS. Short-term variation of MTs was greater in MP compared to CS. Fluctuation in excitability over hours or days in MP is an issue that, until now, has been relatively neglected. The results presented here will help to reconcile conflicting observations.",2012,There were no significant between-group differences in other measures of TMS.,"['patients with migraine (MP', 'migraine']","['transcranial magnetic stimulation (TMS', 'transcranial magnetic stimulation', 'Light deprivation (LD']","['normal excitability', 'motor thresholds (MTs) to TMS, short-interval intracortical inhibition, and ratios between motor-evoked potential amplitudes and supramaximal M responses', 'M1 excitability', 'TMS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}]","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0282617', 'cui_str': 'Evoked Potentials, Motor'}]",,0.0367391,There were no significant between-group differences in other measures of TMS.,"[{'ForeName': 'Adriana B', 'Initials': 'AB', 'LastName': 'Conforto', 'Affiliation': 'Instituto Israelita de Ensino e Pesquisa, Hospital Israelita Albert Einstein, Av. Albert Einstein, 627/2SS, Morumbi, São Paulo, SP, 05652-900, Brazil. adriana.conforto@gmail.com'}, {'ForeName': 'Mariana S', 'Initials': 'MS', 'LastName': 'Moraes', 'Affiliation': ''}, {'ForeName': 'Edson', 'Initials': 'E', 'LastName': 'Amaro', 'Affiliation': ''}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Young', 'Affiliation': ''}, {'ForeName': 'Lais A', 'Initials': 'LA', 'LastName': 'Lois', 'Affiliation': ''}, {'ForeName': 'André L', 'Initials': 'AL', 'LastName': 'Gonçalves', 'Affiliation': ''}, {'ForeName': 'Mario F P', 'Initials': 'MF', 'LastName': 'Peres', 'Affiliation': ''}]",The journal of headache and pain,['10.1007/s10194-011-0379-4'] 517,23660289,Intra-arterial infusion of a glycoprotein IIb/IIIa antagonist for the treatment of thromboembolism during coil embolization of intracranial aneurysm: a comparison of abciximab and tirofiban.,"BACKGROUND AND PURPOSE Abciximab and tirofiban are commonly used for the treatment of thromboembolisms that form during coiling of intracranial aneurysms; however, it is not known which of these inhibitors is safer and more effective. We report the safety and the recanalization rates for intra-arterial abciximab and intra-arterial tirofiban infusion for the treatment of thromboembolisms that form during coiling. MATERIALS AND METHODS Between March 2004 and April 2011, 346 intracranial aneurysms were treated with coiling. Thromboembolisms developed in 22 of these patients and were treated by use of intra-arterial tirofiban (n = 11) or abciximab (n = 11) infusion. RESULTS In the abciximab group, the thromboembolisms were completely (n = 1) or partially (n = 7) resolved in 8 cases (72.7%) at the time of the final control angiography. Complete (n = 9) or partial (n = 2) resolution was achieved in all cases at the time of follow-up angiography (<3 days after the procedure). In the tirofiban group, thromboembolisms were completely (n = 4) or partially (n = 6) resolved in 10 cases (90.9%) at the time of the final control angiography. Complete (n = 9) or partial (n = 2) resolution was observed in all cases at the time of the follow-up angiography. There were no statistically significant differences between the 2 groups with respect to thrombus resolution (final angiography, P = .311; follow-up angiography, P = .707). No hemorrhagic complications developed in either group. CONCLUSIONS These results suggest that tirofiban is more effective than abciximab for the immediate resolution of thromboembolisms, with no statistical significance. Both intra-arterial tirofiban and abciximab exhibited similar safety and recanalization rates.",2013,"There were no statistically significant differences between the 2 groups with respect to thrombus resolution (final angiography, P = .311; follow-up angiography, P = .707).","['thromboembolism during coil embolization of intracranial aneurysm', 'Between March 2004 and April 2011, 346 intracranial aneurysms were treated with coiling']","['Abciximab and tirofiban', 'glycoprotein IIb/IIIa antagonist', 'abciximab and intra-arterial tirofiban infusion', 'abciximab and tirofiban', 'abciximab', 'tirofiban']","['hemorrhagic complications', 'safety and recanalization rates', 'recanalization rates', 'thromboembolisms', 'Thromboembolisms', 'thrombus resolution']","[{'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil (physical object)'}, {'cui': 'C0472410', 'cui_str': 'Embolization of intracranial aneurysm (procedure)'}, {'cui': 'C0007766', 'cui_str': 'Intracranial Aneurysm'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0288672', 'cui_str': 'abciximab'}, {'cui': 'C0247025', 'cui_str': 'tirofiban'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0694634', 'cui_str': 'Intra-arterial (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034771', 'cui_str': 'Recanalization (morphologic abnormality)'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}]",346.0,0.0386984,"There were no statistically significant differences between the 2 groups with respect to thrombus resolution (final angiography, P = .311; follow-up angiography, P = .707).","[{'ForeName': 'H W', 'Initials': 'HW', 'LastName': 'Jeong', 'Affiliation': 'Department of Diagnostic Radiology, Busan Paik Hospital, Inje University, Busan, Korea.'}, {'ForeName': 'S-C', 'Initials': 'SC', 'LastName': 'Jin', 'Affiliation': ''}]",AJNR. American journal of neuroradiology,['10.3174/ajnr.A3501'] 518,23093347,Effects of a single injection of teriparatide on bone turnover markers in postmenopausal women.,"UNLABELLED This study investigated the effects of a single administration of teriparatide on bone turnover markers in postmenopausal women. Teriparatide caused a transient increase in bone resorption and inhibition of bone formation followed by a subsequent increase in bone formation and a decrease in resorption that lasted at least 1 week. INTRODUCTION This study aims to investigate the effects of a single subcutaneous administration of teriparatide on bone turnover markers to elucidate why once weekly intermittent administration of teriparatide is effective on osteoporosis. METHODS Pharmacokinetics and calcium metabolism and bone turnover parameters were measured in 30 postmenopausal women after two doses of teriparatide (28.2 or 56.5 μg injection) or placebo in a randomized, double-blind, placebo-controlled study. RESULTS Teriparatide plasma concentration increased in a dose-dependent manner, and the maximum concentration was achieved 1 h after injection. Serum levels of calcium and phosphorus were transiently increased and decreased after teriparatide injection, respectively. Calcium metabolism returned to baseline levels 24 h later. Two days after injection, the serum level of 1,25-dihydroxy vitamin D was increased by ~80 % from baseline for both doses of teriparatide. Serum levels of osteocalcin and procollagen type I N-terminal propeptide decreased during the first 24 h followed by a ~10 % increase for 14 days. The serum level of cross-linked N-telopeptide (NTX) of type I collagen increased during the first 24 h followed by a 10 to 12 % dose-dependent suppression from baseline for 14 days. Urinary cross-linked C-telopeptide of type I collagen changes occurred in the same direction as serum NTX, but not dose dependently. CONCLUSION A single administration of teriparatide caused an immediate, transient increase in bone resorption and inhibited bone formation followed by an increase in bone formation and decrease in resorption for ≥1 week. These findings may provide proof for the effect of a once-weekly regimen of teriparatide on bone turnover.",2013,Serum levels of osteocalcin and procollagen type I N-terminal propeptide decreased during the first 24 h followed by a ~10 % increase for 14 days.,"['postmenopausal women', '30 postmenopausal women after two doses of', '28.2 or 56.5\xa0μg injection) or']","['Teriparatide', 'teriparatide', 'placebo']","['Urinary cross-linked C-telopeptide of type I collagen changes', 'maximum concentration', 'Serum levels of osteocalcin and procollagen type I N-terminal propeptide', 'serum level of cross-linked N-telopeptide (NTX) of type', 'I collagen', 'bone formation', 'bone turnover markers', 'Teriparatide plasma concentration', 'bone resorption and inhibition of bone formation', 'Serum levels of calcium and phosphorus', 'Calcium metabolism', 'serum level of 1,25-dihydroxy vitamin D', 'bone resorption and inhibited bone formation']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C0041457', 'cui_str': 'Procollagen Type I'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1868706', 'cui_str': 'N-telopeptide'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0029433', 'cui_str': 'Ossification'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0005974', 'cui_str': 'Osteoclastic Bone Loss'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]",30.0,0.170868,Serum levels of osteocalcin and procollagen type I N-terminal propeptide decreased during the first 24 h followed by a ~10 % increase for 14 days.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Shiraki', 'Affiliation': 'Department of Internal Medicine, Research Institute and Practice for Involutional Diseases, 1610-1 Meisei, Misato, Azumino, Nagano, 399-8101, Japan. ripid@fc4.so-net.ne.jp'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Sugimoto', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Nakamura', 'Affiliation': ''}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-012-2159-7'] 519,22965294,The use and efficacy of continuous glucose monitoring in type 1 diabetes treated with insulin pump therapy: a randomised controlled trial.,"AIMS/HYPOTHESIS The aim of this multicentre, randomised, controlled crossover study was to determine the efficacy of adding continuous glucose monitoring (CGM) to insulin pump therapy (CSII) in type 1 diabetes. METHODS Children and adults (n = 153) on CSII with HbA(1c) 7.5-9.5% (58.5-80.3 mmol/mol) were randomised to (CGM) a Sensor On or Sensor Off arm for 6 months. After 4 months' washout, participants crossed over to the other arm for 6 months. Paediatric and adult participants were separately electronically randomised through the case report form according to a predefined randomisation sequence in eight secondary and tertiary centres. The primary outcome was the difference in HbA(1c) levels between arms after 6 months. RESULTS Seventy-seven participants were randomised to the On/Off sequence and 76 to the Off/On sequence; all were included in the primary analysis. The mean difference in HbA(1c) was -0.43% (-4.74 mmol/mol) in favour of the Sensor On arm (8.04% [64.34 mmol/mol] vs 8.47% [69.08 mmol/mol]; 95% CI -0.32%, -0.55% [-3.50, -6.01 mmol/mol]; p < 0.001). Following cessation of glucose sensing, HbA(1c) reverted to baseline levels. Less time was spent with sensor glucose <3.9 mmol/l during the Sensor On arm than in the Sensor Off arm (19 vs 31 min/day; p = 0.009). The mean number of daily boluses increased in the Sensor On arm (6.8 ± 2.5 vs 5.8 ± 1.9, p < 0.0001), together with the frequency of use of the temporary basal rate (0.75 ± 1.11 vs 0.26 ± 0.47, p < 0.0001) and manual insulin suspend (0.91 ± 1.25 vs 0.70 ± 0.75, p < 0.018) functions. Four vs two events of severe hypoglycaemia occurred in the Sensor On and Sensor Off arm, respectively (p = 0.40). CONCLUSIONS/INTERPRETATION Continuous glucose monitoring was associated with decreased HbA(1c) levels and time spent in hypoglycaemia in individuals with type 1 diabetes using CSII. More frequent self-adjustments of insulin therapy may have contributed to these effects.",2012,Less time was spent with sensor glucose <3.9 mmol/l during the Sensor On arm than in the Sensor Off arm (19 vs 31 min/day; p = 0.009).,"['type 1 diabetes treated with', 'Seventy-seven participants', 'Children and adults (n\u2009=\u2009153) on CSII with HbA(1c) 7.5-9.5% (58.5-80.3 mmol/mol', 'type 1 diabetes', 'Paediatric and adult participants']","['continuous glucose monitoring', 'CGM', 'insulin pump therapy', 'continuous glucose monitoring (CGM) to insulin pump therapy (CSII']","['frequency of use of the temporary basal rate', 'severe hypoglycaemia', 'HbA(1c) levels and time spent in hypoglycaemia', 'HbA(1c) levels', 'mean difference in HbA(1c', 'mean number of daily boluses', 'manual insulin suspend']","[{'cui': 'C0011854', 'cui_str': 'Diabetes Mellitus, Type 1'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1705537', 'cui_str': 'Suspended'}]",77.0,0.123473,Less time was spent with sensor glucose <3.9 mmol/l during the Sensor On arm than in the Sensor Off arm (19 vs 31 min/day; p = 0.009).,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Battelino', 'Affiliation': ""UMC-University Children's Hospital, Faculty of Medicine, University of Ljubljana, Bohoričeva 20, Ljubljana, Slovenia. tadej.battelino@mf.uni-lj.si""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Conget', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Olsen', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Schütz-Fuhrmann', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hommel', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hoogma', 'Affiliation': ''}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Schierloh', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Sulli', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bolinder', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetologia,['10.1007/s00125-012-2708-9'] 520,22935960,N-Acetylcysteine inhibits platelet-monocyte conjugation in patients with type 2 diabetes with depleted intraplatelet glutathione: a randomised controlled trial.,"AIMS/HYPOTHESIS The aim of this study was to determine whether oral dosing with N-acetylcysteine (NAC) increases intraplatelet levels of the antioxidant, glutathione (GSH), and reduces platelet-monocyte conjugation in blood from patients with type 2 diabetes. METHODS In this placebo-controlled randomised crossover study, the effect of oral NAC dosing on platelet-monocyte conjugation and intraplatelet GSH was investigated in patients with type 2 diabetes (eligibility criteria: men or post-menopausal women with well-controlled diabetes (HbA(1c) < 10%), not on aspirin or statins). Patients (n = 14; age range 43-79 years, HbA(1c) = 6.9 ± 0.9% [52.3 ± 10.3 mmol/mol]) visited the Highland Clinical Research Facility, Inverness, UK on day 0 and day 7 for each arm of the study. Blood was sampled before and 2 h after oral administration of placebo or NAC (1,200 mg) on day 0 and day 7. Patients received placebo or NAC capsules for once-daily dosing on the intervening days. The order of administration of NAC and placebo was allocated by a central office and all patients and research staff involved in the study were blinded to the allocation until after the study was complete and the data fully analysed. The primary outcome for the study was platelet-monocyte conjugation. RESULTS Oral NAC reduced platelet-monocyte conjugation (from 53.1 ± 4.5% to 42.5 ± 3.9%) at 2 h after administration and the effect was maintained after 7 days of dosing. Intraplatelet GSH was raised in individuals with depleted GSH and there was a negative correlation between baseline intraplatelet GSH and platelet-monocyte conjugation. There were no adverse events. CONCLUSIONS/INTERPRETATION The NAC-induced normalisation of intraplatelet GSH, coupled with a reduction in platelet-monocyte conjugation, suggests that NAC might help to reduce atherothrombotic risk in type 2 diabetes. FUNDING Chief Scientist Office (CZB/4/622), Scottish Funding Council, Highlands & Islands Enterprise and European Regional Development Fund. TRIAL REGISTRATION isrctn.org ISRCTN89304265.",2012,Intraplatelet GSH was raised in individuals with depleted GSH and there was a negative correlation between baseline intraplatelet GSH and platelet-monocyte conjugation.,"['2 diabetes with', 'patients with type', 'patients with type 2 diabetes', 'Patients (n = 14; age range 43-79 years, HbA(1c) = 6.9 ± 0.9% [52.3 ± 10.3 mmol/mol]) visited the Highland Clinical Research Facility, Inverness, UK on day 0 and day 7 for each arm of the study', 'patients with type 2 diabetes (eligibility criteria: men or post-menopausal women with well-controlled diabetes (HbA(1c) < 10%), not on aspirin or statins']","['placebo', 'NAC and placebo', 'N-Acetylcysteine', 'placebo or NAC', 'depleted intraplatelet glutathione', 'N-acetylcysteine (NAC', 'placebo or NAC capsules', 'oral NAC']","['antioxidant, glutathione (GSH', 'atherothrombotic risk', 'platelet-monocyte conjugation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C4517519', 'cui_str': 'Ten point three'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0454911', 'cui_str': 'Highland (geographic location)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0360714', 'cui_str': 'Statins'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}]",,0.226845,Intraplatelet GSH was raised in individuals with depleted GSH and there was a negative correlation between baseline intraplatelet GSH and platelet-monocyte conjugation.,"[{'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Treweeke', 'Affiliation': 'Free Radical Research Facility, Department of Diabetes & Cardiovascular Science, University of the Highlands & Islands, Centre for Health Science, Inverness IV2 3JH, UK.'}, {'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'Winterburn', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Mackenzie', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Barrett', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Barr', 'Affiliation': ''}, {'ForeName': 'G F', 'Initials': 'GF', 'LastName': 'Rushworth', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Dransfield', 'Affiliation': ''}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'MacRury', 'Affiliation': ''}, {'ForeName': 'I L', 'Initials': 'IL', 'LastName': 'Megson', 'Affiliation': ''}]",Diabetologia,['10.1007/s00125-012-2685-z'] 521,23205334,A pilot study to investigate the efficacy of tobramycin-dexamethasone ointment in promoting wound healing.,"INTRODUCTION The standard postsurgical treatment of wounds after dermatologic procedures is currently limited. Topical corticosteroids have been used successfully in postoperative management of ophthalmologic surgeries that involve the skin of the eyelid. In particular, tobramycin 0.3%/dexamethasone 0.1% ophthalmic ointment is considered the ""gold standard"" of steroid-antibiotic fixed combinations and is marketed worldwide as an agent used to control postsurgical inflammation and prevent postsurgical infection. The purpose of this study is to evaluate both the efficacy and safety of tobramycin-dexamethasone ointment for the postsurgical management of Mohs or dermatologic surgery in comparison to white petrolatum. METHODS The authors employed a half-scar study in which patients who underwent skin cancer removal surgery were given tobramycin-dexamethasone ointment and white petrolatum to apply to each half of their wound for 2 weeks. The study was double blinded, and physicians and the patients independently evaluated the scars for cosmetic appearance at 2 and 6 weeks postoperatively. The evaluation criteria included judging which side of the wound looked better based on color, thickness, and discomfort. RESULTS Eighteen patients were enrolled, of which 13 patients completed the three phases of the study. After 6 weeks the wounds did not show a statistically significant difference in color, thickness, or discomfort on either side. CONCLUSION Results obtained to date suggest that the application of tobramycin-dexamethasone ointment to wounds after dermatologic surgery does not promote better wound healing than white petrolatum. These findings indicate that a topical steroid and antibiotic ointment may not be an effective intervention in improving postoperative outcomes in dermatologic surgeries.",2012,"After 6 weeks the wounds did not show a statistically significant difference in color, thickness, or discomfort on either side. ","['patients who underwent skin cancer removal surgery', 'Eighteen patients were enrolled, of which 13 patients completed the three phases of the study']","['tobramycin-dexamethasone ointment', 'Topical corticosteroids', 'tobramycin 0.3%/dexamethasone 0.1% ophthalmic ointment']","['efficacy and safety', 'color, thickness, or discomfort on either side', 'wound healing']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007114', 'cui_str': 'Cancer of Skin'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0040341', 'cui_str': 'Tobramycin'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0028912', 'cui_str': 'Salves'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0304651', 'cui_str': 'Ophthalmic Ointment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}]",18.0,0.0313094,"After 6 weeks the wounds did not show a statistically significant difference in color, thickness, or discomfort on either side. ","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Andrew', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX 75390 USA.'}, {'ForeName': 'Gwendolyn', 'Initials': 'G', 'LastName': 'Luecke', 'Affiliation': ''}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Dozier', 'Affiliation': ''}, {'ForeName': 'Dayna G', 'Initials': 'DG', 'LastName': 'Diven', 'Affiliation': ''}]",Dermatology and therapy,['10.1007/s13555-012-0012-8'] 522,22776860,Effect of denosumab on bone mineral density and biochemical markers of bone turnover: 8-year results of a phase 2 clinical trial.,"UNLABELLED In a phase 2 study, continued denosumab treatment for up to 8 years was associated with continued gains in bone mineral density and persistent reductions in bone turnover markers. Denosumab treatment was well tolerated throughout the 8-year study. INTRODUCTION The purpose of this study is to present the effects of 8 years of continued denosumab treatment on bone mineral density (BMD) and bone turnover markers (BTM) from a phase 2 study. METHODS In the 4-year parent study, postmenopausal women with low BMD were randomized to receive placebo, alendronate, or denosumab. After 2 years, subjects were reallocated to continue, discontinue, or discontinue and reinitiate denosumab; discontinue alendronate; or maintain placebo for two more years. The parent study was then extended for 4 years where all subjects received denosumab. RESULTS Of the 262 subjects who completed the parent study, 200 enrolled in the extension, and of these, 138 completed the extension. For the subjects who received 8 years of continued denosumab treatment, BMD at the lumbar spine (N = 88) and total hip (N = 87) increased by 16.5 and 6.8 %, respectively, compared with their parent study baseline, and by 5.7 and 1.8 %, respectively, compared with their extension study baseline. For the 12 subjects in the original placebo group, 4 years of denosumab resulted in BMD gains comparable with those observed during the 4 years of denosumab in the parent study. Reductions in BTM were sustained over the course of continued denosumab treatment. Reductions also were observed when the placebo group transitioned to denosumab. Adverse event profile was consistent with previous reports and an aging cohort. CONCLUSION Continued denosumab treatment for 8 years was associated with progressive gains in BMD, persistent reductions in BTM, and was well tolerated.",2013,"CONCLUSION Continued denosumab treatment for 8 years was associated with progressive gains in BMD, persistent reductions in BTM, and was well tolerated.","['200 enrolled in the extension, and of these, 138 completed the extension', '262 subjects who completed the parent study', 'postmenopausal women with low BMD']","['placebo', 'discontinue, or discontinue and reinitiate denosumab; discontinue alendronate; or maintain placebo', 'denosumab', 'placebo, alendronate, or denosumab', 'Denosumab']","['bone mineral density (BMD) and bone turnover markers (BTM', 'BTM', 'tolerated', 'progressive gains in BMD', 'bone turnover markers', 'bone mineral density', 'BMD gains', 'bone mineral density and biochemical markers of bone turnover']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Marker'}]",200.0,0.0548728,"CONCLUSION Continued denosumab treatment for 8 years was associated with progressive gains in BMD, persistent reductions in BTM, and was well tolerated.","[{'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'McClung', 'Affiliation': 'Oregon Osteoporosis Center, 5050 NE Hoyt Street, Suite 626, Portland, OR 97213, USA. mmcclung@orost.com'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Lewiecki', 'Affiliation': ''}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Geller', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Bolognese', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Peacock', 'Affiliation': ''}, {'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Weinstein', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Ding', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Rockabrand', 'Affiliation': ''}, {'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Wagman', 'Affiliation': ''}, {'ForeName': 'P D', 'Initials': 'PD', 'LastName': 'Miller', 'Affiliation': ''}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-012-2052-4'] 523,32421814,"Isolating the role of time in bed restriction in the treatment of insomnia: a randomized, controlled, dismantling trial comparing sleep restriction therapy with time in bed regularization.","STUDY OBJECTIVES Sleep restriction therapy (SRT) is one of the most effective treatments for insomnia. Restriction of time in bed (TIB) is assumed to be the central mechanism through which SRT improves sleep consolidation and reduces insomnia symptoms. This hypothesis has never been directly tested. We designed a randomized, controlled, dismantling trial in order to isolate the role of TIB restriction in driving both clinical and polysomnographic sleep outcomes. METHODS Participants aged 25-55 who met diagnostic criteria for insomnia disorder were block-randomized (1:1) to 4 weeks of SRT or time in bed regularization (TBR), a treatment that involves the prescription of a regular but not reduced TIB. The primary outcome was assessed with the insomnia severity index (ISI) at baseline, 4-, and 12-weeks post-randomization. Secondary outcomes included sleep continuity (assessed via polysomnography, actigraphy, and diary) and quality of life. We performed intention-to-treat analyses using linear mixed models. RESULTS Fifty-six participants (39 females, mean age = 40.78 ± 9.08) were assigned to SRT (n = 27) or TBR (n = 29). Daily monitoring of sleep via diaries and actigraphy confirmed large group differences in TIB (d range = 1.63-1.98). At 4-weeks post-randomization, the adjusted mean difference for the ISI was -4.49 (d = -1.40) and -4.35 at 12 weeks (d = -1.36), indicating that the SRT group reported reduced insomnia severity relative to TBR. Robust treatment effects in favor of SRT were also found for objective and self-reported sleep continuity variables (d range = 0.40-0.92) and sleep-related quality of life (d = 1.29). CONCLUSIONS For the first time, we demonstrate that TIB restriction is superior to the regularization of TIB on its own. Our results underscore the centrality of the restriction component in reducing insomnia symptoms and consolidating sleep.",2020,"Robust treatment effects in favour of SRT were also found for objective and self-reported sleep continuity variables (d range=0.40-0.92) and sleep-related quality of life (d=1.29). ","['Fifty-six participants (39 females, mean age=40.78±9.08) were assigned to SRT (n=27) or TBR (n=29', 'Participants aged 25-55 who met DSM-5 diagnostic criteria for insomnia disorder', 'insomnia']","['Sleep restriction therapy (SRT', 'SRT or time in bed regularisation (TBR', 'SRT']","['sleep continuity (assessed via polysomnography, actigraphy, and diary) and quality of life', 'Restriction of time in bed (TIB', 'insomnia severity index (ISI', 'sleep-related quality of life', 'insomnia symptoms and consolidating sleep', 'insomnia severity relative to TBR', 'objective and self-reported sleep continuity variables']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C2584987', 'cui_str': 'Sleep restriction therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C2584987', 'cui_str': 'Sleep restriction therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0456391', 'cui_str': 'Continuities'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",56.0,0.102752,"Robust treatment effects in favour of SRT were also found for objective and self-reported sleep continuity variables (d range=0.40-0.92) and sleep-related quality of life (d=1.29). ","[{'ForeName': 'Leonie Franziska', 'Initials': 'LF', 'LastName': 'Maurer', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Colin Alexander', 'Initials': 'CA', 'LastName': 'Espie', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ximena', 'Initials': 'X', 'LastName': 'Omlin', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Matthew James', 'Initials': 'MJ', 'LastName': 'Reid', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Sharman', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Gavriloff', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Emsley', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Simon David', 'Initials': 'SD', 'LastName': 'Kyle', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}]",Sleep,['10.1093/sleep/zsaa096'] 524,31927569,The effect of cognitive and behavioral therapy for insomnia on week-to-week changes in sleepiness and sleep parameters in patients with comorbid insomnia and sleep apnea: a randomized controlled trial.,"STUDY OBJECTIVES While cognitive and behavioral therapy for insomnia (CBTi) is an effective treatment in patients with comorbid moderate and severe obstructive sleep apnea (OSA), there is concern that the bedtime restriction component of CBTi might dangerously exacerbate daytime sleepiness in such patients. We examined randomized controlled trial data to investigate the effect of OSA severity, and pretreatment daytime sleepiness on week-to-week changes in daytime sleepiness and sleep parameters during CBTi and no-treatment control. METHODS One hundred and forty-five patients with untreated physician-diagnosed OSA (apnea-hypopnea index ≥15) and psychologist-diagnosed insomnia (ICSD-3) were randomized to a 4-week CBTi program (n = 72) or no-treatment control (n = 73). The Epworth sleepiness scale (ESS) and sleep diaries were completed during pretreatment, weekly CBTi sessions, and posttreatment. Effects of OSA severity, pretreatment daytime sleepiness, and intervention group on weekly changes in daytime sleepiness and sleep parameters were investigated. RESULTS The CBTi group reported a 15% increase in ESS scores following the first week of bedtime restriction (M change = 1.3 points, 95% CI = 0.1-2.5, p = 0.031, Cohen's d = 0.27) which immediately returned to pretreatment levels for all subsequent weeks, while sleep parameters gradually improved throughout CBTi. There were no differences in changes in daytime sleepiness during treatment between CBTi and control groups or OSA-severity groups. Higher pretreatment ESS scores were associated with a greater ESS reduction during CBTi. CONCLUSIONS CBTi appears to be a safe and effective treatment in the presence of comorbid moderate and severe OSA. Nevertheless, patients living with comorbid insomnia and sleep apnea and treated with CBTi should be monitored closely for increased daytime sleepiness during the initial weeks of bedtime restriction therapy. CLINICAL TRIAL REGISTRATION Treating comorbid insomnia with obstructive sleep apnoea (COMISA) study: A new treatment strategy for patients with combined insomnia and sleep apnoea, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id = 365184 Australian New Zealand Clinical Trials Registry: ACTRN12613001178730. Universal Trial Number: U1111-1149-4230.",2020,"There were no differences in changes in daytime sleepiness during treatment between CBTi and control groups, or OSA-severity groups.","['145 patients with untreated physician-diagnosed OSA (Apnea-hypopnea index≥15) and psychologist-diagnosed insomnia (ICSD-3', 'insomnia patients with co-morbid moderate and severe sleep apnea', 'patients with co-morbid moderate and severe obstructive sleep apnea (OSA']","['CBTi program', 'cognitive and behavioral therapy', 'CBTi']","['sleepiness and sleep parameters', 'Epworth sleepiness scale (ESS) and sleep diaries', 'daytime sleepiness', 'daytime sleepiness and sleep parameters', 'OSA-severity, pre-treatment daytime sleepiness', 'OSA severity, and pre-treatment daytime sleepiness', 'ESS scores']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing (finding)'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0037315', 'cui_str': 'Sleep Hypopnea'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3541276', 'cui_str': 'ESS - Epworth Sleepiness Scale'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",145.0,0.0147282,"There were no differences in changes in daytime sleepiness during treatment between CBTi and control groups, or OSA-severity groups.","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Sweetman', 'Affiliation': 'Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Bedford Park, Australia.'}, {'ForeName': 'R Doug', 'Initials': 'RD', 'LastName': 'McEvoy', 'Affiliation': 'Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Bedford Park, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': 'Institute for Social Science Research (ISSR), University of Queensland, Indooroopilly, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Catcheside', 'Affiliation': 'Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Bedford Park, Australia.'}, {'ForeName': 'Nick A', 'Initials': 'NA', 'LastName': 'Antic', 'Affiliation': 'Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Bedford Park, Australia.'}, {'ForeName': 'Ching Li', 'Initials': 'CL', 'LastName': 'Chai-Coetzer', 'Affiliation': 'Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Bedford Park, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Douglas', 'Affiliation': 'Thoracic Program, The Prince Charles Hospital, Brisbane, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': ""O'Grady"", 'Affiliation': 'Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Bedford Park, Australia.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Dunn', 'Affiliation': 'Thoracic Program, The Prince Charles Hospital, Brisbane, Australia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Robinson', 'Affiliation': 'Thoracic Program, The Prince Charles Hospital, Brisbane, Australia.'}, {'ForeName': 'Denzil', 'Initials': 'D', 'LastName': 'Paul', 'Affiliation': 'Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Bedford Park, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Williamson', 'Affiliation': 'College of Education Psychology and Social Work, Flinders University, Bedford Park, Australia.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Lack', 'Affiliation': 'Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Bedford Park, Australia.'}]",Sleep,['10.1093/sleep/zsaa002'] 525,23779062,"A randomized, double-blind study of repeated incobotulinumtoxinA (Xeomin(®)) in cervical dystonia.","IncobotulinumtoxinA (Xeomin(®), NT 201), a preparation without accessory (complexing) proteins, has shown comparable efficacy and safety to onabotulinumtoxinA in treating cervical dystonia (CD). This study evaluated the efficacy and safety of repeated incobotulinumtoxinA injections in subjects with CD. Following a ≤20-week placebo-controlled, randomized, double-blind, single-dose main period, subjects could enter a ≤68-week prospective, randomized, double-blind, repeated-dose, flexible-interval (minimum 6 weeks) extension period with 240 U or 120 U of incobotulinumtoxinA (≤5 injections). Outcome measures included the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) and adverse events (AEs). Of 219 subjects completing the main period, 214 were randomized in the extension period to receive incobotulinumtoxinA 240 U (n = 111) or 120 U (n = 103); 169 subjects completed the extension period, with 90 receiving five injection sessions. Both doses of incobotulinumtoxinA provided statistically significant and clinically relevant improvements in mean TWSTRS-Total, -Severity, -Disability, and -Pain scores, from each injection session to respective 4-week follow-up visits. The most frequently reported AE was dysphagia (240 U: 23.4 %; 120 U: 12.6 %), which did not result in any study withdrawals. There was no impact of injection interval on the incidence of AEs (post hoc analysis). A major limitation of this study was the fixed dose design requested by regulatory authorities, which does not reflect clinical practice. However, repeated incobotulinumtoxinA injections (240 or 120 U; flexible intervals) provided sustained efficacy and were well tolerated, with no unexpected safety risks following repeated injections. The incidence of AEs was similar in subjects requiring repeated injections at shorter intervals (≤12 weeks) compared with those treated using longer intervals (>12 weeks).",2013,"Both doses of incobotulinumtoxinA provided statistically significant and clinically relevant improvements in mean TWSTRS-Total, -Severity, -Disability, and -Pain scores, from each injection session to respective 4-week follow-up visits.","['cervical dystonia', '219 subjects completing the main period, 214 were randomized in the extension period to receive', 'n\xa0=\xa0111) or 120\xa0U (n\xa0=\xa0103); 169 subjects completed the extension period, with 90 receiving five injection sessions', 'subjects with CD']","['onabotulinumtoxinA', 'placebo', 'incobotulinumtoxinA injections', 'incobotulinumtoxinA', 'IncobotulinumtoxinA (Xeomin(®), NT 201), a preparation without accessory (complexing) proteins', 'incobotulinumtoxinA 240\xa0U']","['incidence of AEs', 'efficacy and safety', 'mean TWSTRS-Total, -Severity, -Disability, and -Pain scores', 'Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) and adverse events (AEs', 'dysphagia']","[{'cui': 'C0949445', 'cui_str': 'Cervical Dystonia'}, {'cui': 'C4517648', 'cui_str': '219 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2930113', 'cui_str': 'incobotulinumtoxinA'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C2744602', 'cui_str': 'Xeomin'}, {'cui': 'C1688539', 'cui_str': 'NT 201'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0303357', 'cui_str': 'U-240 radioisotope'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0222045'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}]",214.0,0.533636,"Both doses of incobotulinumtoxinA provided statistically significant and clinically relevant improvements in mean TWSTRS-Total, -Severity, -Disability, and -Pain scores, from each injection session to respective 4-week follow-up visits.","[{'ForeName': 'Virgilio Gerald H', 'Initials': 'VG', 'LastName': 'Evidente', 'Affiliation': 'Movement Disorders Center of Arizona, 9590 E. Ironwood Square Drive, #225, Scottsdale, AZ, 85258, USA, vevidente@movementdisorders.us.'}, {'ForeName': 'Hubert H', 'Initials': 'HH', 'LastName': 'Fernandez', 'Affiliation': ''}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'LeDoux', 'Affiliation': ''}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Brashear', 'Affiliation': ''}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Grafe', 'Affiliation': ''}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Hanschmann', 'Affiliation': ''}, {'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Comella', 'Affiliation': ''}]","Journal of neural transmission (Vienna, Austria : 1996)",['10.1007/s00702-013-1048-3'] 526,23700194,Safety and tolerability of sitagliptin in type 2 diabetes: pooled analysis of 25 clinical studies.,"INTRODUCTION In a previous pooled analysis of 19 double-blind clinical studies conducted by Merck, which included data available as of July 2009 on 10,246 patients with type 2 diabetes (T2DM), treatment with sitagliptin was shown to be generally well tolerated compared with treatment with control agents. As the sitagliptin clinical development program continues, additional studies with sitagliptin have been completed. The present analysis updates the safety and tolerability assessment of sitagliptin by examining pooled data from 25 double-blind clinical studies. METHODS The present analysis included data from 14,611 patients in 25 studies with T2DM who received either sitagliptin 100 mg/day (n = 7,726; sitagliptin group) or a comparator agent (n = 6,885; non-exposed group). These studies represent all randomized, double-blind trials conducted by Merck that included patients treated with the usual clinical dose of sitagliptin (100 mg/day) for between 12 weeks and 2 years, and for which results were available as of December 2011. These studies assessed sitagliptin, versus comparator agents, taken as monotherapy, initial combination therapy with metformin or pioglitazone, or as add-on combination therapy with other antihyperglycemic agents (metformin, pioglitazone, a sulfonylurea ± metformin, insulin ± metformin, or metformin + pioglitazone or rosiglitazone). Patient-level data from each study were used to evaluate between-group differences in the exposure-adjusted incidence rates of adverse events (AEs). RESULTS Overall incidence rates of AEs and drug-related AEs were higher in the non-exposed group compared with the sitagliptin group. Incidence rates of specific AEs were generally similar between the two groups, except for higher incidence rates of hypoglycemia related to the greater use of a sulfonylurea and diarrhea related to the greater use of metformin in the non-exposed group, and of constipation in the sitagliptin group. Treatment with sitagliptin was not associated with an increased risk of major adverse cardiovascular events, malignancy, or pancreatitis. CONCLUSION In this updated pooled safety analysis of data from 14,611 patients with T2DM, sitagliptin 100 mg/day was generally well tolerated in clinical trials of up to 2 years in duration.",2013,"RESULTS Overall incidence rates of AEs and drug-related AEs were higher in the non-exposed group compared with the sitagliptin group.","['14,611 patients in 25 studies with T2DM who received either', 'type 2 diabetes', '10,246 patients with type 2 diabetes (T2DM), treatment with', '100\xa0mg/day) for between 12\xa0weeks and 2\xa0years, and for which results were available as of December 2011', '14,611 patients with T2DM']","['sitagliptin 100\xa0mg/day (n\xa0=\xa07,726; sitagliptin group) or a comparator agent (n\xa0', 'metformin', 'sitagliptin', 'antihyperglycemic agents (metformin, pioglitazone, a sulfonylurea\xa0±\xa0metformin, insulin\xa0±\xa0metformin, or metformin\xa0+\xa0pioglitazone or rosiglitazone', 'metformin or pioglitazone']","['risk of major adverse cardiovascular events, malignancy, or pancreatitis', 'Safety and tolerability', 'Incidence rates of specific AEs', 'incidence rates of AEs and drug-related AEs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C1812980', 'cui_str': 'sitagliptin 100 MG'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea Compounds'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0289313', 'cui_str': 'rosiglitazone'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",10246.0,0.0929462,"RESULTS Overall incidence rates of AEs and drug-related AEs were higher in the non-exposed group compared with the sitagliptin group.","[{'ForeName': 'Samuel S', 'Initials': 'SS', 'LastName': 'Engel', 'Affiliation': 'Merck Sharp & Dohme Corp., Whitehouse Station, NJ, USA, samuel.engel@merck.com.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Round', 'Affiliation': ''}, {'ForeName': 'Gregory T', 'Initials': 'GT', 'LastName': 'Golm', 'Affiliation': ''}, {'ForeName': 'Keith D', 'Initials': 'KD', 'LastName': 'Kaufman', 'Affiliation': ''}, {'ForeName': 'Barry J', 'Initials': 'BJ', 'LastName': 'Goldstein', 'Affiliation': ''}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-013-0024-0'] 527,22986920,"Linagliptin increases incretin levels, lowers glucagon, and improves glycemic control in type 2 diabetes mellitus.","INTRODUCTION Linagliptin is a xanthine-based dipeptidyl peptidase (DPP)-4 inhibitor that is now available in numerous countries worldwide for the treatment of type 2 diabetes mellitus (T2DM). The aim of this study was to evaluate further the mechanisms underlying the improvements in glycemic control observed with linagliptin. The effects of linagliptin on DPP-4, pharmacodynamic parameters, and glycemic control versus placebo were assessed in patients with inadequately controlled T2DM. METHODS Patients in this phase 2a, multicenter, randomized, double-blind, placebo-controlled study received placebo (n = 40) or linagliptin 5 mg (n = 40). Sitagliptin 100 mg (n = 41) once daily for 4 weeks was included for exploratory purposes. Primary endpoints for linagliptin versus placebo: change from baseline to day 28 in 24-h weighted mean glucose (WMG) and intact glucagon-like peptide (GLP)-1 area under the time-effect curve between 0 and 2 h (AUEC(0-2h)) following meal tolerance test on day 28. RESULTS Linagliptin increased intact GLP-1 AUEC(0-2h) (+18.1 pmol/h/L) and lowered 24-h WMG (-1.1 mmol/L) versus placebo (both P < 0.0001) after 28 days. Intact glucose-dependent insulinotropic polypeptide increased in line with GLP-1 (+91.4 pmol/h/L increase vs. placebo; P < 0.0001). Glycated hemoglobin (-0.22%; P = 0.0021), fasting plasma glucose (-0.6 mmol/L; P = 0.0283), and glucose (AUEC(0-3h)) (-5.9 mmol/h/L; P < 0.0001) improved significantly with linagliptin versus placebo. Most adverse events were mild; hypoglycemia or serious adverse events were not reported. Sustained DPP-4 inhibition (≥80%) throughout the treatment period was accompanied by significant reductions in glucagon starting at day 1 of linagliptin administration. CONCLUSION Linagliptin was well tolerated and effectively inhibited plasma DPP-4 activity in patients with T2DM, producing immediate improvements in incretin levels, glucagon suppression, and glycemic control that were maintained throughout the study period.",2012,"Glycated hemoglobin (-0.22%; P = 0.0021),","['patients with T2DM', 'type 2 diabetes mellitus', 'patients with inadequately controlled T2DM', 'Patients in this phase 2a, multicenter']","['Linagliptin', 'placebo', 'Sitagliptin', 'linagliptin']","['intact GLP-1 AUEC(0-2h', 'Intact glucose-dependent insulinotropic polypeptide', 'incretin levels, lowers glucagon, and improves glycemic control', 'plasma DPP-4 activity', 'Glycated hemoglobin', 'fasting plasma glucose', 'Sustained DPP-4 inhibition', '24-h weighted mean glucose (WMG) and intact glucagon-like peptide (GLP)-1 area under the time-effect curve between 0 and 2\xa0h (AUEC(0-2h)) following meal tolerance test on day 28', 'lowered 24-h WMG', 'mild; hypoglycemia or serious adverse events', 'DPP-4, pharmacodynamic parameters, and glycemic control', 'incretin levels, glucagon suppression, and glycemic control']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}]","[{'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C1305923', 'cui_str': 'Polypeptides'}, {'cui': 'C1562292', 'cui_str': 'Glucose-Dependent Insulin-Releasing Hormone'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0201777', 'cui_str': 'Tolerance test (procedure)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}]",,0.238263,"Glycated hemoglobin (-0.22%; P = 0.0021),","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rauch', 'Affiliation': 'Boehringer Ingelheim, Ingelheim, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Graefe-Mody', 'Affiliation': ''}, {'ForeName': 'Carolyn F', 'Initials': 'CF', 'LastName': 'Deacon', 'Affiliation': ''}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Ring', 'Affiliation': ''}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': ''}, {'ForeName': 'Hans-Juergen', 'Initials': 'HJ', 'LastName': 'Woerle', 'Affiliation': ''}, {'ForeName': 'Klaus A', 'Initials': 'KA', 'LastName': 'Dugi', 'Affiliation': ''}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Heise', 'Affiliation': ''}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-012-0010-y'] 528,21932014,Phase II placebo-controlled study of nepafenac ophthalmic suspension 0.1% for postoperative inflammation and ocular pain associated with cataract surgery in Japanese patients.,"OBJECTIVE This study aimed to examine the efficacy and safety of nepafenac ophthalmic suspension compared to placebo in the management of postoperative inflammation and ocular pain in Japanese patients undergoing cataract surgery. METHODS This was a multicenter, randomized, double-masked, placebo-controlled clinical study. Patients received nepafenac or placebo TID beginning 1 day before cataract surgery and continuing on the day of surgery for 14 days. One additional drop was administered on the day of surgery. The primary efficacy variables were the percentage of patients cured at postoperative day 14 visit (cure defined as aqueous cells score + aqueous flare score = 0) and the percentage of patients who were pain free at all postoperative visits. RESULTS The cure rate on day 14 after surgery was 71.4% (75/105) in the nepafenac group and 28.6% (30/105) in the placebo group, showing a significant difference in cure rate between groups. The nepafenac group demonstrated higher cure rates than those in the placebo group, with a significant difference in cure rate on days 7 and 14 postoperatively. The ocular pain-free rate was 96.2% (102/106) in the nepafenac group and 67.6% (71/105) in the placebo group, showing a significant difference between groups. Concerning adverse events (AEs), 26 AEs were reported in 21 subjects (19.6%) in the nepafenac group and 31 AEs were reported in 24 subjects (22.4%) in the placebo group. CONCLUSION Nepafenac ophthalmic suspension is a nonsteroidal anti-inflammatory drug effective in the prevention of postoperative inflammation and ocular pain associated with cataract surgery.",2011,"The nepafenac group demonstrated higher cure rates than those in the placebo group, with a significant difference in cure rate on days 7 and 14 postoperatively.","['Japanese patients', 'Japanese patients undergoing cataract surgery']","['placebo', 'Nepafenac ophthalmic suspension', 'nepafenac or placebo TID', 'nepafenac', 'nepafenac ophthalmic suspension']","['efficacy and safety', 'postoperative inflammation and ocular pain', 'percentage of patients cured at postoperative day\xa014 visit (cure defined as aqueous cells score\u2009+\u2009aqueous flare score', 'ocular pain-free rate', 'cure rates', 'cure rate']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3530973', 'cui_str': 'nepafenac Ophthalmic Suspension [Ilevro]'}, {'cui': 'C0961209', 'cui_str': 'nepafenac'}, {'cui': 'C0908863', 'cui_str': 'TIDS'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0151827', 'cui_str': 'Eye pain'}, {'cui': 'C0438113', 'cui_str': 'Patient cured (finding)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0524490', 'cui_str': 'Aqueous Flare'}]",,0.303482,"The nepafenac group demonstrated higher cure rates than those in the placebo group, with a significant difference in cure rate on days 7 and 14 postoperatively.","[{'ForeName': 'Jiro', 'Initials': 'J', 'LastName': 'Numaga', 'Affiliation': 'Department of Ophthalmology, Tokyo Metropolitan Geriatric Hospital, 35-2 Sakae-cho, Itabashi-ku, Tokyo, 173-0015, Japan, jnumaga@mub.biglobe.ne.jp.'}]",Journal of ophthalmic inflammation and infection,['10.1007/s12348-011-0036-8'] 529,31693129,Phase III Randomized Trial of Bisphosphonates as Adjuvant Therapy in Breast Cancer: S0307.,"BACKGROUND Adjuvant bisphosphonates, when given in a low-estrogen environment, can decrease breast cancer recurrence and death. Treatment guidelines include recommendations for adjuvant bisphosphonates in postmenopausal patients. SWOG/Alliance/Canadian Cancer Trials Group/ECOG-ACRIN/NRG Oncology study S0307 compared the efficacy of three bisphosphonates in early-stage breast cancer. METHODS Patients with stage I-III breast cancer were randomly assigned to 3 years of intravenous zoledronic acid, oral clodronate, or oral ibandronate. The primary endpoint was disease-free survival (DFS) with overall survival as a secondary outcome. All statistical tests were two-sided. RESULTS A total of 6097 patients enrolled. Median age was 52.7 years. Prior to being randomly assigned, 73.2% patients indicated preference for oral vs intravenous formulation. DFS did not differ across arms in a log-rank test (P = .49); 5-year DFS was 88.3% (zoledronic acid: 95% confidence interval [CI] = 86.9% to 89.6%), 87.6% (clodronate: 95% CI = 86.1% to 88.9%), and 87.4% (ibandronate: 95% CI = 85.6% to 88.9%). Additionally, 5-year overall survival did not differ between arms (log rank P = .50) and was 92.6% (zoledronic acid: 95% CI = 91.4% to 93.6%), 92.4% (clodronate: 95% CI = 91.2% to 93.5%), and 92.9% (ibandronate: 95% CI = 91.5% to 94.1%). Bone as first site of recurrence did not differ between arms (P = .93). Analyses based on age and tumor subtypes showed no treatment differences. Grade 3/4 toxicity was 8.8% (zoledronic acid), 8.3% (clodronate), and 10.5% (ibandronate). Osteonecrosis of the jaw was highest for zoledronic acid (1.26%) compared with clodronate (0.36%) and ibandronate (0.77%). CONCLUSIONS We found no evidence of differences in efficacy by type of bisphosphonate, either in overall analysis or subgroups. Despite an increased rate of osteonecrosis of the jaw with zoledronic acid, overall toxicity grade differed little across arms. Given that patients expressed preference for oral formulation, efforts to make oral agents available in the United States should be considered.",2020,"Osteonecrosis of the Jaw (ONJ) was highest for zoledronic acid (1.26%), compared to clodronate (0.36%) and ibandronate (0.77%). ","['Patients with stage I-III breast cancer', '6,097 patients enrolled', 'breast cancer', 'Median age was 52.7 years', 'early stage breast cancer', 'postmenopausal patients']","['clodronate', 'bisphosphonate', 'zoledronic acid', 'intravenous zoledronic acid, oral clodronate, or oral ibandronate', 'bisphosphonates']","['Osteonecrosis of the Jaw (ONJ', 'breast cancer recurrence and death', 'Grade 3/4 toxicity', 'disease-free survival (DFS) with overall survival (OS', 'DFS', '5-year', 'rate of ONJ with zoledronic acid, overall toxicity grade']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}]","[{'cui': 'C0162357', 'cui_str': 'Clodronate'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonates'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0379199', 'cui_str': 'Ibandronate'}]","[{'cui': 'C0029445', 'cui_str': 'Osteonecrosis'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}]",,0.212636,"Osteonecrosis of the Jaw (ONJ) was highest for zoledronic acid (1.26%), compared to clodronate (0.36%) and ibandronate (0.77%). ","[{'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Gralow', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Barlow', 'Affiliation': 'SWOG Statistical Center, Seattle, WA.'}, {'ForeName': 'Alexander H G', 'Initials': 'AHG', 'LastName': 'Paterson', 'Affiliation': 'Tom Baker Cancer Centre, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Jieling L', 'Initials': 'JL', 'LastName': ""M'iao"", 'Affiliation': 'SWOG Statistical Center, Seattle, WA.'}, {'ForeName': 'Danika L', 'Initials': 'DL', 'LastName': 'Lew', 'Affiliation': 'SWOG Statistical Center, Seattle, WA.'}, {'ForeName': 'Alison T', 'Initials': 'AT', 'LastName': 'Stopeck', 'Affiliation': 'Stony Brook Cancer Center, Stony Brook University Cancer Center, Stony Brook, NY.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hayes', 'Affiliation': 'University of Michigan, Ann Arbor, MI (DFH, CHVP); Columbia University, New York, NY.'}, {'ForeName': 'Dawn L', 'Initials': 'DL', 'LastName': 'Hershman', 'Affiliation': ''}, {'ForeName': 'Mark M', 'Initials': 'MM', 'LastName': 'Schubert', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Clemons', 'Affiliation': 'Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Catherine H', 'Initials': 'CH', 'LastName': 'Van Poznak', 'Affiliation': ''}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Dees', 'Affiliation': 'University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Ingle', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Carla I', 'Initials': 'CI', 'LastName': 'Falkson', 'Affiliation': 'University of Alabama, Birmingham, AL.'}, {'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'Elias', 'Affiliation': 'University of Colorado, Denver, CO.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Messino', 'Affiliation': 'Cancer Care of WNC, Greenville, NC.'}, {'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Margolis', 'Affiliation': 'Beaumont NCORP/William Beaumont Hospital, Royal Oak, MI.'}, {'ForeName': 'Shaker R', 'Initials': 'SR', 'LastName': 'Dakhil', 'Affiliation': 'Wichita NCORP, Wichita, KS.'}, {'ForeName': 'Helen K', 'Initials': 'HK', 'LastName': 'Chew', 'Affiliation': 'University of California at Davis, Sacramento, CA.'}, {'ForeName': 'Kim Z', 'Initials': 'KZ', 'LastName': 'Dammann', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Abrams', 'Affiliation': 'Cancer Therapy and Evaluation Program, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Livingston', 'Affiliation': 'University of Arizona, Tucson, AZ.'}, {'ForeName': 'Gabriel N', 'Initials': 'GN', 'LastName': 'Hortobagyi', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}]",Journal of the National Cancer Institute,['10.1093/jnci/djz215'] 530,23011680,Are changes in bone mineral density different between groups of early rheumatoid arthritis patients treated according to a tight control strategy with or without prednisone if osteoporosis prophylaxis is applied?,"UNLABELLED Addition of 10 mg prednisone daily to a methotrexate-based tight control strategy does not lead to bone loss in early rheumatoid arthritis (RA) patients receiving preventive treatment for osteoporosis. A small increase in lumbar bone mineral density (BMD) during the first year of treatment was recorded, regardless of use of glucocorticoids. INTRODUCTION This study aims to describe effects on BMD of treatment according to EULAR guidelines with a methotrexate-based tight control strategy including 10 mg prednisone daily versus the same strategy without prednisone in early RA patients who received preventive therapy for osteoporosis. METHODS Early RA patients were included in the CAMERA-II trial: a randomized, placebo-controlled, double-blind 2-year trial, in which effects of addition of 10 mg prednisone daily to a methotrexate-based tight control strategy were studied. All patients received calcium, vitamin D and bisphosphonates. Disease activity was assessed every 4 weeks. Radiographs of hands and feet and dual-energy X-ray absorptiometry of lumbar spine and left hip were performed at baseline and after 1 and 2 years of treatment. RESULTS BMD increased significantly over time in both treatment groups at the lumbar spine with a mean of 2.6% during the first year (p<0.001), but not at the hip; at none of the time points did BMD differ significantly between the prednisone and placebo group. Higher age and lower weight at baseline and higher disease activity scores during the trial, but not glucocorticoid therapy, were associated with lower BMD at both the lumbar spine and the hip in mixed-model analyses. CONCLUSION Addition of 10 mg prednisone daily to a methotrexate-based tight control strategy does not lead to bone loss in early RA patients on bisphosphonates. A small increase in lumbar BMD during the first year of treatment was found, regardless of use of glucocorticoids.",2013,"A small increase in lumbar bone mineral density (BMD) during the first year of treatment was recorded, regardless of use of glucocorticoids. ","['Early RA patients', 'early RA patients who received preventive therapy for osteoporosis', 'early rheumatoid arthritis patients', 'early rheumatoid arthritis (RA) patients receiving preventive treatment for osteoporosis', 'early RA patients on bisphosphonates']","['prednisone daily to a methotrexate-based tight control strategy', 'placebo', 'prednisone', 'methotrexate-based tight control strategy', 'calcium, vitamin D and bisphosphonates']","['disease activity scores', 'bone loss', 'BMD', 'bone mineral density', 'Disease activity', 'lumbar bone mineral density (BMD', 'lumbar BMD']","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonates'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0453911', 'cui_str': 'Tights (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonates'}]","[{'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}]",,0.12506,"A small increase in lumbar bone mineral density (BMD) during the first year of treatment was recorded, regardless of use of glucocorticoids. ","[{'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'van der Goes', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, University Medical Center Utrecht, PO Box 85500, 3508, GA, Utrecht, The Netherlands. m.c.vandergoes@umcutrecht.nl'}, {'ForeName': 'J W G', 'Initials': 'JW', 'LastName': 'Jacobs', 'Affiliation': ''}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Jurgens', 'Affiliation': ''}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Bakker', 'Affiliation': ''}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'van der Veen', 'Affiliation': ''}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'van der Werf', 'Affiliation': ''}, {'ForeName': 'P M J', 'Initials': 'PM', 'LastName': 'Welsing', 'Affiliation': ''}, {'ForeName': 'J W J', 'Initials': 'JW', 'LastName': 'Bijlsma', 'Affiliation': ''}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-012-2073-z'] 531,32423730,CPAP Effects on Oxygen Delivery in One-Lung Ventilation During Minimally Invasive Surgical Ablation for Atrial Fibrillation in The Supine Position.,"OBJECTIVE In minimally invasive surgical ablation for atrial fibrillation during video-assisted thoracoscopy surgery, one-lung ventilation (OLV) with a double- lumen tube is commonly employed. In contrast with the majority of thoracic procedures, the patient lies supine; thus, the protective effect of gravity is lost and intrapulmonary shunt remains high. To decrease intrapulmonary shunt and to increase oxygenation, many strategies are utilized: high inspiratory fraction of oxygen (F I O 2 ), positive end-expiratory pressure on the ventilated lung, and continuous positive airway pressure (CPAP) on the deflated lung. DESIGN The authors performed a prospective, single- center, randomized study to evaluate the effect of additional CPAP in the nonventilated lung on oxygen delivery during surgical ablation for atrial fibrillation via video-assisted thoracoscopy in the supine position. SETTING University hospital Centro Cardiologico Monzino IRCCS, Milano, Italy. PARTICIPANTS Twenty-two patients scheduled for minimally invasive surgical ablation for atrial fibrillation. INTERVENTIONS The patients underwent pressure-controlled ventilation, adjusting inspiratory pressure to obtain a tidal volume of 7 mL/kg while keeping F I O 2 constantly 1.0, a respiratory rate to maintain arterial partial pressure of carbon dioxide (PaCO 2 ) between 35 and 40 mmHg, and positive end-expiratory pressure of 5 cmH 2 O. During OLV, inspiratory pressure was reduced to obtain a tidal volume of 5 mL/kg, maintaining F I O 2 of 1.0, a respiratory rate to maintain PaCO 2 between 35 and 40 mmHg with capnothorax of 10 cmH 2 O. The patients were then randomized into the CPAP group (CPAP 10 cmH 2 0 on deflated lung) and NO CPAP group. Inotropic agents (dopamine or dobutamine) were used if cardiac index fell below 1.5 L/min/m 2 . MEASUREMENTS AND MAIN RESULTS Twenty-two patients were enrolled, randomized, and completed the study. Median age was 62 years. The difference in arterial partial pressure of oxygen between the 2 groups was shy of significance, p = 0.16. Cardiac index progressively increased during OLV until the end of the procedure in both groups (p < 0.01) and was maintained above 1.5 mL/min/m 2 during the whole study time. Arterial oxygen content remained stable during the entire procedure in both groups (p = 0.27). Oxygen delivery index (DO 2 I) increased significantly during the procedure (p < 0.01); nevertheless, the difference in DO 2 I between the CPAP and NO CPAP group was nonsignificant (p = 0.61). Intrapulmonary shunt (Q s /Q t ) increased during OLV (p < 0.01 for the time effect) and remained high until total lung ventilation was reintroduced. No difference in Q s /Q t was observed between the CPAP and NO CPAP groups (p = 0.98). Similarly, mean pulmonary artery pressure increased significantly during OLV and remained high at the end of the procedure in both groups (time effect p < 0.01). CONCLUSIONS During OLV for atrial fibrillation surgical ablation in the supine position, CPAP on the deflated lung seemed to be ineffective to reduce Q s /Q t or to increase arterial partial pressure of oxygen and DO 2 I, provided cardiac output was maintained above 1.5 L/min/m 2 .",2020,"The difference in arterial partial pressure of oxygen between the 2 groups was shy of significance, p = 0.16.","['One-Lung Ventilation', 'Twenty-two patients scheduled for minimally invasive surgical ablation for atrial fibrillation', 'University hospital Centro Cardiologico Monzino IRCCS, Milano, Italy', 'Twenty-two patients', 'Median age was 62 years']","['additional CPAP', 'CPAP group (CPAP 10 cmH 2 0 on deflated lung) and NO CPAP', 'video-assisted thoracoscopy surgery, one-lung ventilation (OLV', 'pressure-controlled ventilation, adjusting inspiratory pressure to obtain a tidal volume of 7 mL/kg while keeping F I O 2 constantly 1.0, a respiratory rate to maintain arterial partial pressure of carbon dioxide (PaCO 2 ) between 35 and 40 mmHg, and positive end-expiratory pressure of 5 cmH 2 O', 'CPAP', 'Inotropic agents (dopamine or dobutamine', 'minimally invasive surgical ablation']","['Arterial oxygen content', 'Cardiac index', 'Oxygen delivery index', 'Q s /Q', 'mean pulmonary artery pressure', 'arterial partial pressure of oxygen and DO 2 I, provided cardiac output', 'Oxygen Delivery', 'arterial partial pressure of oxygen']","[{'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0949658', 'cui_str': 'Primary familial hypertrophic cardiomyopathy'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C2923055', 'cui_str': 'Video assisted thoracoscopy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C0564626', 'cui_str': 'Pressure controlled ventilation'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0428190', 'cui_str': 'Measurement of arterial partial pressure of carbon dioxide'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0304509', 'cui_str': 'Inotropic agent'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0012963', 'cui_str': 'Dobutamine'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0523806', 'cui_str': 'Oxygen measurement'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index'}, {'cui': 'C0429622', 'cui_str': 'Oxygen delivery'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}]",22.0,0.0544509,"The difference in arterial partial pressure of oxygen between the 2 groups was shy of significance, p = 0.16.","[{'ForeName': 'Camilla', 'Initials': 'C', 'LastName': ""L'Acqua"", 'Affiliation': 'Department of Anesthesia and Intensive Care, Centro Cardiologico Monzino IRCCS, Milano, Italy. Electronic address: Camilla.lacqua@gmail.com.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Meli', 'Affiliation': ""Department of Medical Surgical Pathophysiology and Organ Transplantation, Universita' Degli Studi Di Milano Statale, Milano, Italy.""}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Rondello', 'Affiliation': 'Department of Anesthesia and Intensive Care, Centro Cardiologico Monzino IRCCS, Milano, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Polvani', 'Affiliation': 'Department of Cardiac Surgery, Centro Cardiologico Monzino IRCCS, Milano, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Salvi', 'Affiliation': 'Department of Anesthesia and Intensive Care, Centro Cardiologico Monzino IRCCS, Milano, Italy.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.03.064'] 532,32422285,Randomized trial of topical periocular castor oil treatment for blepharitis.,"PURPOSE To evaluate the effects of topical castor oil application to the eyelids on ocular surface and tear film parameters in patients with blepharitis. METHODS Twenty-six participants (14 females, 12 males; mean ± SD age, 38 ± 21 years) with clinical signs of blepharitis were enrolled in a prospective, investigator-masked, randomized, paired-eye trial. A 100% cold pressed castor oil formulation (Lotus Garden Botanicals, Biddeford, ME, USA) was applied to the eyelids of one eye (randomized), twice daily for 4 weeks. Ocular surface characteristics, symptoms, and tear film parameters were assessed at baseline and day 28. RESULTS Baseline measurements did not differ between treated and control eyes (all p > 0.05). A significant reduction in OSDI symptomology score was observed following the four-week treatment period (p = 0.001). Clinical improvements in eyelid margin thickening, telangiectasia, eyelash matting, madarosis, cylindrical dandruff, and lid wiper epitheliopathy were limited to treated eyes (all p < 0.01), while greater decreases in staphylococcal and seborrheic eyelash crusting were observed in treated than control eyes (both p < 0.05). No adverse events were reported during the treatment period. CONCLUSION Topical castor oil application effected significant improvements in ocular surface signs and symptoms in patients with blepharitis. The favourable therapeutic profile would suggest that castor oil demonstrates promise as a potential treatment for blepharitis, and support the conduct of further efficacy trials with longer follow up. TRIAL REGISTRATION NUMBER ACTRN12618000856213.",2021,"RESULTS Baseline measurements did not differ between treated and control eyes (all p > 0.05).","['Twenty-six participants (14 females, 12 males; mean\u202f±\u202fSD age, 38\u202f±\u202f21 years) with clinical signs of blepharitis', 'patients with blepharitis', 'blepharitis']","['topical castor oil application', 'cold pressed castor oil formulation (Lotus Garden Botanicals, Biddeford, ME, USA', 'topical periocular castor oil treatment', 'castor oil']","['staphylococcal and seborrheic eyelash crusting', 'Ocular surface characteristics, symptoms, and tear film parameters', 'OSDI symptomology score', 'ocular surface and tear film parameters', 'adverse events', 'ocular surface signs and symptoms', 'eyelid margin thickening, telangiectasia, eyelash matting, madarosis, cylindrical dandruff, and lid wiper epitheliopathy']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0005741', 'cui_str': 'Blepharitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0007343', 'cui_str': 'Castor Oil'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0330839', 'cui_str': 'Lotus'}, {'cui': 'C0868963', 'cui_str': 'Gardening'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0015422', 'cui_str': 'Structure of eyelash'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0449588', 'cui_str': 'Surface characteristics'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0015426', 'cui_str': 'Eyelid structure'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0205400', 'cui_str': 'Thickened'}, {'cui': 'C0039446', 'cui_str': 'Telangiectasis'}, {'cui': 'C0271321', 'cui_str': 'Madarosis of eyelid'}, {'cui': 'C0205114', 'cui_str': 'Cylindrical'}, {'cui': 'C0221244', 'cui_str': 'Seborrheic dermatitis of scalp'}]",26.0,0.0298868,"RESULTS Baseline measurements did not differ between treated and control eyes (all p > 0.05).","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Muntz', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Sandford', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand; Tauranga Eye Specialists, Tauranga, New Zealand.'}, {'ForeName': 'Marna', 'Initials': 'M', 'LastName': 'Claassen', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand; Department of Optometry and Vision Science, New Zealand National Eye Centre, The University of Auckland, New Zealand.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Curd', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand; Department of Optometry and Vision Science, New Zealand National Eye Centre, The University of Auckland, New Zealand.'}, {'ForeName': 'Alice K', 'Initials': 'AK', 'LastName': 'Jackson', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand; Department of Optometry and Vision Science, New Zealand National Eye Centre, The University of Auckland, New Zealand.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Watters', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand.'}, {'ForeName': 'Michael T M', 'Initials': 'MTM', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand.'}, {'ForeName': 'Jennifer P', 'Initials': 'JP', 'LastName': 'Craig', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand. Electronic address: jp.craig@auckland.ac.nz.'}]",The ocular surface,['10.1016/j.jtos.2020.05.007'] 533,22549506,A randomized controlled trial comparing two types of pneumatic compression for breast cancer-related lymphedema treatment in the home.,"PURPOSE Pneumatic compression devices (PCDs) are used in the home setting as adjunctive treatment for lymphedema after acute treatment in a clinical setting. PCDs range in complexity from simple to technologically advanced. The objective of this prospective, randomized study was to determine whether an advanced PCD (APCD) provides better outcomes as measured by arm edema and tissue water reductions compared to a standard PCD (SPCD) in patients with arm lymphedema after breast cancer treatment. METHODS Subjects were randomized to an APCD (Flexitouch system, HCPCS E0652) or SPCD (Bio Compression 2004, HCPCS E0651) used for home treatment 1 h/day for 12 weeks. Pressure settings were 30 mmHg for the SPCD and upper extremity treatment program (UE01) with standard pressure for the APCD. Thirty-six subjects (18 per group) with unilateral upper extremity lymphedema with at least 5% arm edema volume at the time of enrollment, completed treatments over the 12-week period. Arm volumes were determined from arm girth measurements and suitable model calculations, and tissue water was determined based on measurements of the arm tissue dielectric constant (TDC). RESULTS The APCD-treated group experienced an average of 29% reduction in edema compared to a 16% increase in the SPCD group. Mean changes in TDC values were a 5.8% reduction for the APCD group and a 1.9% increase for the SPCD group. CONCLUSION This study suggests that for the home maintenance phase of treatment of arm lymphedema secondary to breast cancer therapy, the adjuvant treatment with an APCD provides better outcomes than with a SPCD.",2012,"Mean changes in TDC values were a 5.8% reduction for the APCD group and a 1.9% increase for the SPCD group. ","['patients with arm lymphedema after breast cancer treatment', 'breast cancer-related lymphedema treatment in the home', 'Thirty-six subjects (18 per group) with unilateral upper extremity lymphedema with at least 5% arm', 'Subjects']","['advanced PCD (APCD', 'standard PCD (SPCD', 'Pneumatic compression devices (PCDs', 'APCD (Flexitouch system, HCPCS E0652) or SPCD ', 'pneumatic compression']","['edema', 'edema volume', 'Mean changes in TDC values']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}]","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0269241,"Mean changes in TDC values were a 5.8% reduction for the APCD group and a 1.9% increase for the SPCD group. ","[{'ForeName': 'Caroline E', 'Initials': 'CE', 'LastName': 'Fife', 'Affiliation': 'Department of Internal Medicine, Division of Cardiology, University of Texas Health Science Center, Memorial Hermann Center for Wound Care and Lymphedema Management, 6431 Fannin, MSB 1.247, Houston, TX 77030, USA. Caroline.E.Fife@uth.tmc.edu'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Davey', 'Affiliation': ''}, {'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Maus', 'Affiliation': ''}, {'ForeName': 'Renie', 'Initials': 'R', 'LastName': 'Guilliod', 'Affiliation': ''}, {'ForeName': 'Harvey N', 'Initials': 'HN', 'LastName': 'Mayrovitz', 'Affiliation': ''}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-012-1455-2'] 534,23801770,Global small bowel motility: assessment with dynamic MR imaging.,"PURPOSE To assess the repeatability in human volunteers of software-quantified small bowel motility captured with magnetic resonance (MR) imaging and to test the ability to detect changes in motility induced by pharmacologic agents. MATERIALS AND METHODS The study was approved by the Royal Free Research Ethics Committee, and all subjects gave full written informed consent. Twenty-one healthy volunteers (14 men, seven women; mean age, 28 years) underwent cine MR imaging with a three-dimensional balanced turbo field-echo sequence to capture small bowel motility. Volume blocks (15 cm thick) were acquired every second during a 20-second breath hold. A randomized, blinded, placebo-controlled crossover study of either 0.5 mg neostigmine or saline (n = 11) or 20 mg intravenous butylscopolamine or saline (n = 10) was performed with motility MR imaging at baseline and repeated at a mean of 4 weeks (range, 2-7 weeks). Two readers independently drew regions of interest around the small bowel, and motility was quantified by using a registration algorithm that provided a global motility metric in arbitrary units. Repeatability of the motility measurements at baseline was assessed by using Bland-Altman and within-subject coefficient of variation measures. Changes in mean motility measurements after drug administration were compared with those after placebo administration by using paired t testing. RESULTS The repeatability between baseline measurements of motility was high; the Bland-Altman mean difference was -0.0025 (range, 0.28-0.4), the 95% limit of agreement was ±0.044 arbitrary units (au), and the within-subject coefficient of variation was 4.9%. Measured motility with neostigmine (mean, 0.39 au) was significantly higher than that with placebo (mean, 0.34 au; P < .001), whereas that with butylscopolamine (mean, 0.13 au) was significantly lower than that with placebo (mean, 0.30 au; P < .001). CONCLUSION Quantification of small bowel motility with use of MR imaging in healthy volunteers is repeatable and sensitive to changes induced by means of pharmacologic manipulation. SUPPLEMENTAL MATERIAL http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.13130151/-/DC1.",2013,"The repeatability between baseline measurements of motility was high; the Bland-Altman mean difference was -0.0025 (range, 0.28-0.4), the 95% limit of agreement was ±0.044 arbitrary units (au), and the within-subject coefficient of variation was 4.9%.","['mean age, 28 years) underwent', 'Twenty-one healthy volunteers (14 men, seven women', 'human volunteers', 'healthy volunteers']","['placebo', 'butylscopolamine or saline', 'neostigmine or saline', 'cine MR imaging with a three-dimensional balanced turbo field-echo sequence to capture small bowel motility', 'magnetic resonance (MR) imaging', 'dynamic MR imaging', 'butylscopolamine']","['Repeatability of the motility measurements', 'Global small bowel motility', 'Measured motility with neostigmine', 'mean motility measurements']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0020155', 'cui_str': 'Human Volunteers'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006519', 'cui_str': 'butylscopolamine bromide'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0232618', 'cui_str': 'Small bowel motility, function (observable entity)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}]","[{'cui': 'C1510470', 'cui_str': 'Motility (observable entity)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0232618', 'cui_str': 'Small bowel motility, function (observable entity)'}, {'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",21.0,0.088782,"The repeatability between baseline measurements of motility was high; the Bland-Altman mean difference was -0.0025 (range, 0.28-0.4), the 95% limit of agreement was ±0.044 arbitrary units (au), and the within-subject coefficient of variation was 4.9%.","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Menys', 'Affiliation': 'Centre for Medical Imaging, University College London, 3rd Floor East, 250 Euston Rd, London NW1 2PG, England; GI Physiology Unit, University College London Hospital, London, England.'}, {'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Taylor', 'Affiliation': ''}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Emmanuel', 'Affiliation': ''}, {'ForeName': 'Asia', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': ''}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Plumb', 'Affiliation': ''}, {'ForeName': 'Freddy', 'Initials': 'F', 'LastName': 'Odille', 'Affiliation': ''}, {'ForeName': 'Ahsan', 'Initials': 'A', 'LastName': 'Alam', 'Affiliation': ''}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Halligan', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Atkinson', 'Affiliation': ''}]",Radiology,['10.1148/radiol.13130151'] 535,23737536,Image noise reduction algorithm for digital subtraction angiography: clinical results.,"PURPOSE To test the hypothesis that an image noise reduction algorithm designed for digital subtraction angiography (DSA) in interventional neuroradiology enables a reduction in the patient entrance dose by a factor of 4 while maintaining image quality. MATERIALS AND METHODS This clinical prospective study was approved by the local ethics committee, and all 20 adult patients provided informed consent. DSA was performed with the default reference DSA program, a quarter-dose DSA program with modified acquisition parameters (to reduce patient radiation dose exposure), and a real-time noise-reduction algorithm. Two consecutive biplane DSA data sets were acquired in each patient. The dose-area product (DAP) was calculated for each image and compared. A randomized, blinded, offline reading study was conducted to show noninferiority of the quarter-dose image sets. Overall, 40 samples per treatment group were necessary to acquire 80% power, which was calculated by using a one-sided α level of 2.5%. RESULTS The mean DAP with the quarter-dose program was 25.3% ± 0.8 of that with the reference program. The median overall image quality scores with the reference program were 9, 13, and 12 for readers 1, 2, and 3, respectively. These scores increased slightly to 12, 15, and 12, respectively, with the quarter-dose program imaging chain. CONCLUSION In DSA, a change in technique factors combined with a real-time noise-reduction algorithm will reduce the patient entrance dose by 75%, without a loss of image quality.",2013,"The median overall image quality scores with the reference program were 9, 13, and 12 for readers 1, 2, and 3, respectively.",['20 adult patients provided informed consent'],"['Image noise reduction algorithm', 'DSA', 'digital subtraction angiography (DSA']","['median overall image quality scores', 'mean DAP', 'dose-area product (DAP']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0002045'}, {'cui': 'C0002979', 'cui_str': 'Angiography, Digital Subtraction'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0525921', 'cui_str': 'alpha,beta-diacryloxypropionic acid'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]",20.0,0.0416675,"The median overall image quality scores with the reference program were 9, 13, and 12 for readers 1, 2, and 3, respectively.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Söderman', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet and Department of Neuroradiology, Karolinska University Hospital, Stockholm 17176, Sweden; Department of Hospital Physics, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Staffan', 'Initials': 'S', 'LastName': 'Holmin', 'Affiliation': ''}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Andersson', 'Affiliation': ''}, {'ForeName': 'Charlotta', 'Initials': 'C', 'LastName': 'Palmgren', 'Affiliation': ''}, {'ForeName': 'Draženko', 'Initials': 'D', 'LastName': 'Babic', 'Affiliation': ''}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Hoornaert', 'Affiliation': ''}]",Radiology,['10.1148/radiol.13121262'] 536,32060506,Impact of a 4-hour Introductory eFAST Training Intervention Among Ultrasound-Naïve U.S. Military Medics.,"INTRODUCTION Advances in the portability of ultrasound have allowed it to be increasingly employed at the point of care in austere settings. Battlefield constraints often limit the availability of medical officers throughout the operational environment, leading to increased interest in whether highly portable ultrasound devices can be employed by military medics to enhance their provision of combat casualty care. Data evaluating optimal training for effective medic employment of ultrasound is limited however. This prospective observational cohort study's primary objective was to assess the impact of a 4-hour introductory training intervention on ultrasound-naïve military medic participants' knowledge/performance of the eFAST application. MATERIALS AND METHODS Conventional U.S. Army Medics, all naïve to ultrasound, were recruited from across JBLM. Volunteer participants underwent baseline eFAST knowledge assessment via a 50-question multiple-choice exam. Participants were then randomized to receive either conventional, expert-led classroom didactic training or didactic training via an online, asynchronously available platform. All participants then underwent expert-led, small group hands-on training and practice. Participants' eFAST performance was then assessed with both live and phantom models, followed by a post-course knowledge exam. Concurrently, emergency medicine (EM) resident physician volunteers, serving as standard criterion for trained personnel, underwent the same OSCE assessments, followed by a written exam to assess their baseline eFAST knowledge. Primary outcome measures included (1) post-course knowledge improvement, (2) eFAST exam technical adequacy, and (3) eFAST exam OSCE score. Secondary outcome measures were time to exam completion and diagnostic accuracy rate for hemoperitoneum and hemopericardium. These outcome measures were then compared across medic cohorts and to those of the EM resident physician cohort. RESULTS A total of 34 medics completed the study. After 4 hours of ultrasound training, overall eFAST knowledge among the 34 medics improved from a baseline mean of 27% on the pretest to 83% post-test. For eFAST exam performance, the medics scored an average of 20.8 out of a maximum of 22 points on the OSCE. There were no statistically significant differences between the medics who received asynchronous learning versus traditional classroom-based learning, and the medics demonstrated comparable performance to previously trained EM resident physicians. CONCLUSIONS A 4-hour introductory eFAST training intervention can effectively train conventional military medics to perform the eFAST exam. Online, asynchronously available platforms may effectively mitigate some of the resource requirement burden associated with point-of-care ultrasound training. Future studies evaluating medic eFAST performance on real-world battlefield trauma patients are needed. Skill and knowledge retention must also be assessed for this degradable skill to determine frequency of refresher training when not regularly performed.",2020,"There were no statistically significant differences between the medics who received asynchronous learning versus traditional classroom-based learning, and the medics demonstrated comparable performance to previously trained EM resident physicians. ","['A total of 34 medics completed the study', 'Volunteer participants underwent baseline eFAST knowledge assessment via a 50-question multiple-choice exam', 'Conventional U.S. Army Medics, all naïve to ultrasound, were recruited from across JBLM']","['4-hour Introductory eFAST Training Intervention', 'asynchronous learning', 'conventional, expert-led classroom didactic training or didactic training via an online, asynchronously available platform', '4-hour introductory training intervention', 'introductory eFAST training intervention']","['time to exam completion and diagnostic accuracy rate for hemoperitoneum and hemopericardium', 'overall eFAST knowledge', '1) post-course knowledge improvement, (2) eFAST exam technical adequacy, and (3) eFAST exam OSCE score']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}]","[{'cui': 'C1292426', 'cui_str': '4 hours (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439581', 'cui_str': 'Asynchronous (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0019065', 'cui_str': 'Hemoperitoneum'}, {'cui': 'C0019064', 'cui_str': 'Hemopericardium'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C4704780', 'cui_str': 'Extended Focused Assessment with Sonography for Trauma'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0579016,"There were no statistically significant differences between the medics who received asynchronous learning versus traditional classroom-based learning, and the medics demonstrated comparable performance to previously trained EM resident physicians. ","[{'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Monti', 'Affiliation': 'Henry M. Jackson Foundation for the Advancement of Military Medicine, Madigan Army Medical Center, 9040 Jackson Avenue, Joint Base Lewis-McChord, Washington 98431.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Perreault', 'Affiliation': 'Department of Emergency Medicine, Madigan Army Medical Center, 9040 Jackson Avenue, Joint Base Lewis-McChord, Washington 98431.'}]",Military medicine,['10.1093/milmed/usaa014'] 537,32061387,The effect of early measles vaccination on morbidity and growth: A randomised trial from Guinea-Bissau.,"BACKGROUND Measles vaccine (MV) has beneficial non-specific effects protecting against non-measles infections in some situations. Within a trial of the effect of MV on mortality, we assessed effects of early MV on the secondary outcomes consultations and growth, overall, and by sex and exposure to campaigns with oral polio vaccine (OPV). MATERIALS AND METHODS Children were randomly assigned to MV at 4.5 + 9 months or MV at 9 months as recommended. At enrolment and 9 months children had their mid-upper-arm-circumference (MUAC) and weight measured. Consultations (out/inpatient) were registered at monthly home visits. Weight-for-age and MUAC-for-age Z-scores were obtained using the WHO growth reference and compared by group in linear regression models. Consultation rates between enrolment and 9 months were compared in Cox proportional hazards models, providing consultation Hazard Ratios (HRs) for early MV versus no early MV. We tested whether the effect of early MV was modified by OPV campaigns by splitting observation time at exposure to OPV campaigns. RESULTS Among 3548 children enrolled between 2012 and 2015, early MV had no effect on MUAC-for-age (mean difference comparing early MV vs. no MV -0.01, 95% CI -0.06-0.04), weight-for-age (mean difference -0.03, 95% CI -0.07-0.02) or rates of consultations (HR = 1.03, 95% CI 0.92-1.16). The rate of consultations for children enrolled was lower after exposure to OPV campaigns (HR = 0.81, 95% CI 0.71-0.92). The effect of MV differed before exposure to OPV campaigns (HR = 1.12, 95% CI 0.98-1.29) and after OPV campaigns (HR = 0.83, 95% CI 0.67-1.03) (test for interaction: p = 0.03). Associations did not differ by sex. CONCLUSION Early MV had no overall effect on consultation rates and growth between enrolment and 9 months of age. However, early MV tended to have beneficial effects for children subsequently exposed to OPV campaigns. As beneficial effects were observed in subgroups, the results should be interpreted with caution. CLINICAL TRIALS REGISTRATION NCT01644721.",2020,"The rate of consultations for children enrolled was lower after exposure to OPV campaigns (HR = 0.81, 95% CI 0.71-0.92).","['Children', '3548 children enrolled between 2012 and 2015, early MV']","['MV', 'oral polio vaccine (OPV', 'vaccine (MV']","['morbidity and growth', 'Consultation rates', 'rate of consultations']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0032371', 'cui_str': 'Poliomyelitis Infection'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0032375', 'cui_str': 'Sabin Vaccine'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]",3548.0,0.237296,"The rate of consultations for children enrolled was lower after exposure to OPV campaigns (HR = 0.81, 95% CI 0.71-0.92).","[{'ForeName': 'Mette Møller', 'Initials': 'MM', 'LastName': 'Steiniche', 'Affiliation': 'Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau; Research Center for Vitamins and Vaccines (CVIVA), Statens Serum Institut, Copenhagen S, Denmark.'}, {'ForeName': 'Sanne Marie', 'Initials': 'SM', 'LastName': 'Thysen', 'Affiliation': 'Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau; Research Center for Vitamins and Vaccines (CVIVA), Statens Serum Institut, Copenhagen S, Denmark; Center for Global Health (GloHAU), Department of Public Health, Aarhus University, Aarhus C, Denmark.'}, {'ForeName': 'Aksel Karl Georg', 'Initials': 'AKG', 'LastName': 'Jensen', 'Affiliation': 'Research Center for Vitamins and Vaccines (CVIVA), Statens Serum Institut, Copenhagen S, Denmark; Section of Biostatistics, University of Copenhagen, Copenhagen K, Denmark.'}, {'ForeName': 'Amabelia', 'Initials': 'A', 'LastName': 'Rodrigues', 'Affiliation': 'Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau.'}, {'ForeName': 'Cesario', 'Initials': 'C', 'LastName': 'Martins', 'Affiliation': 'Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau.'}, {'ForeName': 'Dan Wolf', 'Initials': 'DW', 'LastName': 'Meyrowitsch', 'Affiliation': 'Global Health Section, Department of Public Health, University of Copenhagen, Copenhagen K, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Aaby', 'Affiliation': 'Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau.'}, {'ForeName': 'Ane Bærent', 'Initials': 'AB', 'LastName': 'Fisker', 'Affiliation': 'Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau; Research Center for Vitamins and Vaccines (CVIVA), Statens Serum Institut, Copenhagen S, Denmark; OPEN, Institute of Clinical Research, University of Southern Denmark/Odense University Hospital, Odense C, Denmark. Electronic address: a.fisker@bandim.org.'}]",Vaccine,['10.1016/j.vaccine.2020.01.096'] 538,31536819,Combined resection-recession in true divergence excess sensory exotropia.,"PURPOSE To assess the effect of combined resection and recession on the same lateral rectus muscle in patients with true divergence excess sensory exotropia. METHODS Patients were divided into two groups. One group of patients underwent combined resection-recession of the lateral rectus muscle in one eye (LR group); the other group, with exodeviation of >40 Δ for distance underwent additional ipsilateral medial rectus resection (LR + MR group). Postoperative measurements were taken at 1 week, 1 month, and 3 months. RESULTS Eleven patients were included in the study (mean age, 23.5 ± 6.7 years): 7 in the LR group and 4 in the LR + MR group. For the LR group, mean preoperative deviation was 35.7 Δ ± 3.5 Δ at distance and 16.3 Δ ± 3.9 Δ at near. The mean near-distance disparity (NDD) was 11.4 Δ  ± 2.7 Δ . The mean lateral rectus recession was 8.6 ± 1.1 mm: the mean resection, 4.3 ± 0.5 mm. At 3 months, mean deviation at distance was 8.3 Δ ± 2.1 Δ ; at near, 3.1 Δ ± 1.6 Δ (P = 0.01). The NDD was 5.7 Δ ± 2.7 Δ (P = 0.01). For the LR + MR group, mean preoperative deviations at distance was 65.0 Δ ± 12.9 Δ ; at near, 35.0 Δ ± 12.2 Δ . The mean NDD was 30.0 Δ ± 4.0 Δ . Mean lateral rectus recession was 9.5 ± 1.8 mm; the mean resection, 4.8 ± 0.8 mm. The mean medial rectus resection was 5.5 ± 0.6 mm. At 3 months, mean deviation at distance was 8.3 Δ ± 2.1 Δ ; at near, 3.1 Δ ± 1.6 Δ (P = 0.06). The NDD was 5.7 Δ ± 2.7 Δ (P = 0.06). CONCLUSIONS In our study combined resection and recession of the same lateral rectus muscle in patients with divergence excess sensory exotropia significantly reduced the NDD, with no adverse outcomes.",2019,"The mean lateral rectus recession was 8.6 ± 1.1 mm: the mean resection, 4.3 ± 0.5 mm.","['Eleven patients were included in the study (mean age, 23.5 ± 6.7 years): 7 in the LR group and 4 in the LR+MR group', 'Patients were divided into two groups', 'patients with true divergence excess sensory exotropia']","['Combined resection-recession', 'combined resection-recession of the lateral rectus muscle in one eye (LR group); the other group, with exodeviation of >40 Δ for distance underwent additional ipsilateral medial rectus resection (LR+MR group', 'combined resection and recession']","['mean lateral rectus recession', 'mean medial rectus resection', 'Mean lateral rectus recession', 'mean near-distance disparity (NDD', 'mean preoperative deviation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0205238', 'cui_str': 'True (qualifier value)'}, {'cui': 'C1409057', 'cui_str': 'Divergence excess'}, {'cui': 'C1276000', 'cui_str': 'Sensory exotropia'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0333047', 'cui_str': 'Recession (morphologic abnormality)'}, {'cui': 'C0582821', 'cui_str': 'Lateral rectus muscle structure (body structure)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4551670', 'cui_str': 'Exodeviation'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}, {'cui': 'C0395297', 'cui_str': 'Medial rectus resection (procedure)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0395310', 'cui_str': 'Lateral rectus recession (procedure)'}, {'cui': 'C0395297', 'cui_str': 'Medial rectus resection (procedure)'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}]",40.0,0.0250946,"The mean lateral rectus recession was 8.6 ± 1.1 mm: the mean resection, 4.3 ± 0.5 mm.","[{'ForeName': 'Karthika', 'Initials': 'K', 'LastName': 'Bhaskaran', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Adarsh Kumar', 'Initials': 'AK', 'LastName': 'Shashni', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India. Electronic address: drpsharma57@yahoo.com.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Saxena', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Phuljhele', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}]",Journal of AAPOS : the official publication of the American Association for Pediatric Ophthalmology and Strabismus,['10.1016/j.jaapos.2019.06.009'] 539,32057574,A randomized phase II trial to compare safety and immunogenicity of the MVA-BN smallpox vaccine at various doses in adults with a history of AIDS.,"Traditional replicating smallpox vaccines are associated with serious safety concerns in the general population and are contraindicated in immunocompromised individuals. However, this very population remains at greatest risk for severe complications following viral infections, making vaccine prevention particularly relevant. MVA-BN was developed as a non-replicating smallpox vaccine that is potentially safer for people who are immunocompromised. In this phase II trial, 3 MVA-BN dosing regimens were evaluated for safety, tolerability, and immunogenicity in persons with HIV (PWH) who had a history of AIDS. Following randomization, 87 participants who were predominately male and African American received either 2 standard doses on weeks 0 and 4 in the standard dose (SD) group (N = 27), 2 double-standard doses on the same schedule in the double dose (DD) group (N = 29), or 3 standard doses on weeks 0, 4 and 12 in the booster dose (BD) group (N = 31). No safety concerns were identified, and injection site pain was the most commonly reported solicited adverse event (AE) in all groups (66.7%), with no meaningful differences between groups. The incidence of severe (Grade 3) AEs was low across groups and no serious AEs or AEs of special interest considered related to study vaccine were reported. Doubling the standard MVA-BN dose had no significant effect on induction of neutralizing antibodies, with 100% seroconversion and comparable GMTs at week 6 in the SD and DD groups (78.9 and 100.3, respectively). A booster dose significantly increased peak neutralizing titers in the BD group (GMT: 281.1), which remained elevated at 12 months (GMT: 45.3) compared to the SD (GMT: 6.2) and DD (GMT: 10.6) groups. However, based on the immune response previously reported for healthy participants, a third dose (booster) does not appear necessary, even for immunocompromised participants. Clinical Trial Registry Number: NCT02038881.",2020,"A booster dose significantly increased peak neutralizing titers in the BD group (GMT: 281.1), which remained elevated at 12 months (GMT: 45.3) compared to the SD (GMT: 6.2) and DD (GMT: 10.6) groups.","['people who are immunocompromised', 'healthy participants', 'persons with HIV (PWH) who had a history of AIDS', '87 participants who were predominately male and African American', 'adults with a history of AIDS']",['MVA-BN smallpox vaccine'],"['safety, tolerability, and immunogenicity', 'peak neutralizing titers', 'induction of neutralizing antibodies']","[{'cui': 'C0085393', 'cui_str': 'Immunosuppressed Host'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0332251', 'cui_str': 'Predominate (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C2939181', 'cui_str': 'Motor vehicle traffic accident (event)'}, {'cui': 'C0037355', 'cui_str': 'Smallpox Vaccine'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}]",3.0,0.0833935,"A booster dose significantly increased peak neutralizing titers in the BD group (GMT: 281.1), which remained elevated at 12 months (GMT: 45.3) compared to the SD (GMT: 6.2) and DD (GMT: 10.6) groups.","[{'ForeName': 'Edgar Turner', 'Initials': 'ET', 'LastName': 'Overton', 'Affiliation': 'Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Lawrence', 'Affiliation': 'Division of Infectious Diseases, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Jack T', 'Initials': 'JT', 'LastName': 'Stapleton', 'Affiliation': 'Division of Infectious Diseases, Departments of Internal Medicine, Microbiology & Immunology, University of Iowa Carver College of Medicine and Iowa City Veterans Administration Healthcare, Iowa City, IA, USA.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Weidenthaler', 'Affiliation': 'Bavarian Nordic GmbH, Fraunhoferstrasse 13, 82152 Martinsried, Germany. Electronic address: Heinz.Weidenthaler@bavarian-nordic.com.'}, {'ForeName': 'Darja', 'Initials': 'D', 'LastName': 'Schmidt', 'Affiliation': 'Bavarian Nordic GmbH, Fraunhoferstrasse 13, 82152 Martinsried, Germany.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Koenen', 'Affiliation': 'Bavarian Nordic GmbH, Fraunhoferstrasse 13, 82152 Martinsried, Germany.'}, {'ForeName': 'Günter', 'Initials': 'G', 'LastName': 'Silbernagl', 'Affiliation': 'Bavarian Nordic GmbH, Fraunhoferstrasse 13, 82152 Martinsried, Germany.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Nopora', 'Affiliation': 'Bavarian Nordic GmbH, Fraunhoferstrasse 13, 82152 Martinsried, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Chaplin', 'Affiliation': 'Bavarian Nordic A/S, Hejreskovvej 10A, DK-3490 Kvistgård, Denmark.'}]",Vaccine,['10.1016/j.vaccine.2020.01.058'] 540,21208675,Targeting dietary fat or glycemic load in the treatment of obesity and type 2 diabetes: a randomized controlled trial.,"AIMS To compare the effects of lifestyle modification programs that prescribe low-glycemic load (GL) vs. low-fat diets in a randomized trial. METHODS Seventy-nine obese adults with type 2 diabetes received low-fat or low-GL dietary instruction, delivered in 40-week lifestyle modification programs with identical goals for calorie intake and physical activity. Changes in weight, HbA(1c), and other metabolic parameters were compared at weeks 20 and 40. RESULTS Weight loss did not differ between groups at week 20 (low-fat: -5.7±3.7%; low-GL: -6.7±4.4%, p=.26) or week 40 (low-fat: -4.5±7.5%; low-GL: -6.4±8.2%, p=.28). Adjusting for changes in antidiabetic medications, subjects on the low-GL diet had larger reductions in HbA(1c) than those on the low-fat diet at week 20 (low-fat: -0.3±0.6%; low-GL: -0.7±0.6%, p=.01), and week 40 (low-fat: -0.1±1.2%; low-GL: -0.8±1.3%; p=.01). Groups did not differ significantly on any other metabolic outcomes (p≥.06). CONCLUSIONS Results suggest that targeting GL, rather than dietary fat, in a low-calorie diet can significantly enhance the effect of weight loss on HbA(1c) in patients with type 2 diabetes.",2011,"Groups did not differ significantly on any other metabolic outcomes (p≥.06). ","['Seventy-nine obese adults with type 2 diabetes received', 'obesity and type 2 diabetes', 'patients with type 2 diabetes']","['Targeting dietary fat or glycemic load', 'low-fat or low-GL dietary instruction, delivered in 40-week lifestyle modification programs with identical goals for calorie intake and physical activity', 'lifestyle modification programs that prescribe low-glycemic load (GL) vs. low-fat diets']","['weight loss on HbA(1c', 'Changes in weight, HbA(1c), and other metabolic parameters', 'metabolic outcomes', 'Weight loss']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0012171', 'cui_str': 'Dietary Fats'}, {'cui': 'C4042927', 'cui_str': 'Glycemic Load'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",79.0,0.0225604,"Groups did not differ significantly on any other metabolic outcomes (p≥.06). ","[{'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Fabricatore', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania School of Medicine, United States. fabricat@mail.med.upenn.edu'}, {'ForeName': 'T A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': ''}, {'ForeName': 'C B', 'Initials': 'CB', 'LastName': 'Ebbeling', 'Affiliation': ''}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Thomas', 'Affiliation': ''}, {'ForeName': 'V A', 'Initials': 'VA', 'LastName': 'Stallings', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Schwartz', 'Affiliation': ''}, {'ForeName': 'D S', 'Initials': 'DS', 'LastName': 'Ludwig', 'Affiliation': ''}]",Diabetes research and clinical practice,['10.1016/j.diabres.2010.12.016'] 541,21243486,Direction and magnitude of nicotine effects on the fMRI BOLD response are related to nicotine effects on behavioral performance.,"Considerable variability across individuals has been reported in both the behavioral and fMRI blood oxygen level-dependent (BOLD) response to nicotine. We aimed to investigate (1) whether there is a heterogeneous effect of nicotine on behavioral and BOLD responses across participants and (2) if heterogeneous BOLD responses are associated with behavioral performance measures. In this double-blind, placebo-controlled, cross-over study, 41 healthy participants (19 smokers)--drawn from a larger population-based sample--performed a visual oddball task after acute challenge with 1 mg nasal nicotine. fMRI data and reaction time were recorded during performance of the task. Across the entire group of subjects, we found increased activation in the anterior cingulate cortex, middle frontal gyrus, superior temporal gyrus, post-central gyrus, planum temporal and frontal pole in the nicotine condition compared with the placebo condition. However, follow-up analyses of this difference in activation between the placebo and nicotine conditions revealed that some participants showed an increase in activation while others showed a decrease in BOLD activation from the placebo to the nicotine condition. A reduction of BOLD activation from placebo to nicotine was associated with a decrease in reaction time and reaction time variability and vice versa, suggesting that it is the direction of BOLD response to nicotine which is related to task performance. We conclude that the BOLD response to nicotine is heterogeneous and that the direction of response to nicotine should be taken into account in future pharmaco-fMRI research on the central action of nicotine.",2011,"A reduction of BOLD activation from placebo to nicotine was associated with a decrease in reaction time and reaction time variability and vice versa, suggesting that it is the direction of BOLD response to nicotine which is related to task performance.",['41 healthy participants (19 smokers)--drawn from a larger population-based sample--performed a visual oddball task after acute challenge with 1 mg'],"['nasal nicotine', 'placebo', 'nicotine']","['activation', 'behavioral and BOLD responses', 'BOLD activation', 'behavioral performance', 'reaction time and reaction time variability', 'fMRI data and reaction time', 'anterior cingulate cortex, middle frontal gyrus, superior temporal gyrus, post-central gyrus, planum temporal and frontal pole']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}]","[{'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0152309', 'cui_str': 'Gyrus Temporalis Superior'}, {'cui': 'C0152302', 'cui_str': 'Gyrus Postcentralis'}, {'cui': 'C2936787', 'cui_str': 'Planum'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0149546', 'cui_str': 'Structure of frontal pole'}]",41.0,0.0676992,"A reduction of BOLD activation from placebo to nicotine was associated with a decrease in reaction time and reaction time variability and vice versa, suggesting that it is the direction of BOLD response to nicotine which is related to task performance.","[{'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Warbrick', 'Affiliation': 'Department of Psychiatry, Heinrich-Heine University, Düsseldorf, Germany. t.warbrick@fz-juelich.de'}, {'ForeName': 'Arian', 'Initials': 'A', 'LastName': 'Mobascher', 'Affiliation': ''}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Brinkmeyer', 'Affiliation': ''}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Musso', 'Affiliation': ''}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Stoecker', 'Affiliation': ''}, {'ForeName': 'N Jon', 'Initials': 'NJ', 'LastName': 'Shah', 'Affiliation': ''}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Vossel', 'Affiliation': ''}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Winterer', 'Affiliation': ''}]",Psychopharmacology,['10.1007/s00213-010-2145-8'] 542,32057576,Safety and immunogenicity of novel modified vaccinia Ankara-vectored RSV vaccine: A randomized phase I clinical trial.,"Respiratory disease caused by RSV infection is recognized as a severe public health issue in infants, young children and elderly with no specific treatment option. Vaccination may be the most effective strategy to combat this highly infectious virus although no vaccine has been approved. The novel vaccine candidate MVA-BN-RSV encodes RSV surface proteins F and G (subtypes A, B) as well as internal proteins N and M2 in the MVA-BN viral vector backbone to provide broad protection against RSV. This was a first in human study to investigate safety, reactogenicity and immunogenicity of MVA-BN-RSV. Sixty-three participants were allocated to 3 groups: adult (18-49 years) low (1 × 10 7 TCID 50 ) or high (1 × 10 8 TCID 50 ) dose and older adult (50-65 years) high dose. Participants in each group were randomized in a 6:1 ratio to receive 2 doses of MVA-BN-RSV or placebo 4 weeks apart and were monitored for 30 weeks. All participants completed the study, receiving both doses. No serious AEs or AEs of special interest were reported. The most common AEs were injection site pain (56% in the combined high dose groups, 17% in the low dose group). MVA-BN-RSV induced robust T cell responses covering all 5 inserts with fold increases ranging from 1.8 to 3.8. Higher and broader responses were observed in the high dose groups (83% responders to at least 3 peptide pools in the combined high dose groups compared to 63% in the low dose group). Moderate but consistent humoral responses were observed against A and B RSV subtypes (up to approximately 2-fold increases in the high dose groups). No differences were observed between the adult and the older adult groups in safety, reactogenicity or immunogenicity. The study demonstrated that the well tolerated MVA-BN-RSV vaccine candidate induces broad cellular and humoral immune responses, warranting further development.",2020,MVA-BN-RSV induced robust T cell responses covering all 5 inserts with fold increases ranging from 1.8 to 3.8.,"['infants, young children and elderly with no specific treatment option', 'Sixty-three participants were allocated to 3 groups: adult (18-49\xa0years) low']","['MVA-BN-RSV', 'novel modified vaccinia Ankara-vectored RSV vaccine', 'MVA-BN-RSV or placebo']","['robust T cell responses', 'Safety and immunogenicity', 'safety, reactogenicity or immunogenicity', 'injection site pain', 'humoral responses']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C2939181', 'cui_str': 'Motor vehicle traffic accident (event)'}, {'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0042214', 'cui_str': 'Vaccinia'}, {'cui': 'C0887894', 'cui_str': 'RSV Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain (disorder)'}]",63.0,0.078061,MVA-BN-RSV induced robust T cell responses covering all 5 inserts with fold increases ranging from 1.8 to 3.8.,"[{'ForeName': 'Nathaly', 'Initials': 'N', 'LastName': 'Samy', 'Affiliation': 'Bavarian Nordic GmbH, Fraunhoferstrasse 13, 82152 Martinsried, Germany.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Reichhardt', 'Affiliation': 'Bavarian Nordic GmbH, Fraunhoferstrasse 13, 82152 Martinsried, Germany.'}, {'ForeName': 'Darja', 'Initials': 'D', 'LastName': 'Schmidt', 'Affiliation': 'Bavarian Nordic GmbH, Fraunhoferstrasse 13, 82152 Martinsried, Germany.'}, {'ForeName': 'Liddy M', 'Initials': 'LM', 'LastName': 'Chen', 'Affiliation': 'Bavarian Nordic Inc, 3025 Carrington Mill Boulevard, Morrisville, NC 27560, United States.'}, {'ForeName': 'Günter', 'Initials': 'G', 'LastName': 'Silbernagl', 'Affiliation': 'Bavarian Nordic GmbH, Fraunhoferstrasse 13, 82152 Martinsried, Germany.'}, {'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Vidojkovic', 'Affiliation': 'Bavarian Nordic GmbH, Fraunhoferstrasse 13, 82152 Martinsried, Germany.'}, {'ForeName': 'Thomas Ph', 'Initials': 'TP', 'LastName': 'Meyer', 'Affiliation': 'Bavarian Nordic GmbH, Fraunhoferstrasse 13, 82152 Martinsried, Germany.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Jordan', 'Affiliation': 'Bavarian Nordic GmbH, Fraunhoferstrasse 13, 82152 Martinsried, Germany.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Adams', 'Affiliation': 'Bavarian Nordic GmbH, Fraunhoferstrasse 13, 82152 Martinsried, Germany.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Weidenthaler', 'Affiliation': 'Bavarian Nordic GmbH, Fraunhoferstrasse 13, 82152 Martinsried, Germany. Electronic address: Heinz.Weidenthaler@bavarian-nordic.com.'}, {'ForeName': 'Daria', 'Initials': 'D', 'LastName': 'Stroukova', 'Affiliation': 'Bavarian Nordic GmbH, Fraunhoferstrasse 13, 82152 Martinsried, Germany.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'De Carli', 'Affiliation': 'Bavarian Nordic GmbH, Fraunhoferstrasse 13, 82152 Martinsried, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Chaplin', 'Affiliation': 'Bavarian Nordic A/S, Hejreskovvej 10A, DK-3490 Kvistgård, Denmark.'}]",Vaccine,['10.1016/j.vaccine.2020.01.055'] 543,32141831,Considering the first randomized trial of peroral endoscopic myotomy versus surgical myotomy for achalasia.,,2020,,[],['peroral endoscopic myotomy'],[],[],"[{'cui': 'C0185181', 'cui_str': 'Myotomy'}]",[],,0.0262965,,"[{'ForeName': 'Cem', 'Initials': 'C', 'LastName': 'Şimşek', 'Affiliation': 'Department of Gastroenterology, Hacettepe University School of Medicine, Ankara, Turkey.'}]",The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology,['10.5152/tjg.2020.250220'] 544,32431238,Extraversion as a Moderator of the Efficacy of Self-Esteem Maintenance Strategies.,"Four experiments explored how extraversion's connection with self-esteem may depend on specific self-enhancement strategies. Participants' self-esteem threatening feedback indicating that they had performed poorly on a vocabulary or emotional intelligence test. In Experiment 1, participants ( N = 80) were randomly assigned to either a control condition (no self-enhancement) or a downward social comparison condition. The procedures for Experiments 2 ( N = 470) and 3 ( N = 514) were similar, adding a self-serving attribution condition (Experiments 2 and 3) and Basking-in-Reflected-Glory (BIRG) condition (Experiment 3). Across the experiments, extraversion was more related to self-esteem under downward social comparison versus other conditions. BIRGing produced higher self-esteem in Experiment 3 across extraversion levels. Experiment 4 ( N = 355) focused on downward social comparison versus control, and provided evidence that an increased perception of being similar to the comparison targets may partially explain extraversion's self-esteem link. Theoretical implications concerning both extraversion and self-enhancement are discussed.",2021,BIRGing produced higher self-esteem in Experiment 3 across extraversion levels.,['participants ( N = 80'],['control condition (no self-enhancement) or a downward social comparison condition'],['self-esteem'],[],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0205104', 'cui_str': 'Down'}]","[{'cui': 'C0036597', 'cui_str': 'Self-esteem'}]",514.0,0.011076,BIRGing produced higher self-esteem in Experiment 3 across extraversion levels.,"[{'ForeName': 'Thomas I', 'Initials': 'TI', 'LastName': 'Vaughan-Johnston', 'Affiliation': ""Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'MacGregor', 'Affiliation': 'The Ohio State University, Columbus, USA.'}, {'ForeName': 'Leandre R', 'Initials': 'LR', 'LastName': 'Fabrigar', 'Affiliation': ""Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Lyndsay E', 'Initials': 'LE', 'LastName': 'Evraire', 'Affiliation': 'University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Wasylkiw', 'Affiliation': 'Mount Allison University, Sackville, New Brunswick, Canada.'}]",Personality & social psychology bulletin,['10.1177/0146167220921713'] 545,31521518,The impact of intranasal fluticasone on patients with obstructive sleep apnea: a prospective study.,"INTRODUCTION Obstructive sleep apnea is the most common type of sleep apnea, which is caused by complete or partial obstructions of the upper airway. Nasal obstruction is also considered as one of the independent risk factors of obstructive sleep apnea. OBJECTIVE Patients with obstructive sleep apnea. METHODS We enrolled patients with obstructive sleep apnea from June to December 2015 and treated them with intranasal corticosteroid spray for four weeks. Several parameters were obtained before and after the treatment, including Nasal Obstruction Symptom Evaluation scores, Pittsburgh Sleep Quality Index questionnaire and Epworth Sleepiness Scale questionnaire. RESULTS Fifty patients completed questionnaires prior to and following the intranasal fluticasone treatments. The average age was 39.7 ± 15.6 y, with a male to female ratio of 3:2. The post-treatment Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, and Nasal Obstruction Symptom Evaluation scores all indicated a decrease compared to pre-treatment scores, from 10.4 to 8.74, 7.86 to 6.66 and 9.08 to 6.48, respectively. A significant decrease was observed in the Nasal Obstruction Symptom Evaluation ≥10 group in all three categories, but not in the Nasal Obstruction Symptom Evaluation <10 group. CONCLUSIONS Intranasal fluticasone treatment may be useful for patients with nasal obstruction-related obstructive sleep apnea to improve sleep quality and limit daytime dysfunction.",2021,"The post-treatment Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, and Nasal Obstruction Symptom Evaluation scores all indicated a decrease compared to pre-treatment scores, from 10.4 to 8.74, 7.86 to 6.66 and 9.08 to 6.48, respectively.","['enrolled patients with obstructive sleep apnea from June to December 2015 and treated them with', 'patients with nasal obstruction-related obstructive sleep apnea', 'The average age was 39.7\u202f±\u202f15.6\u202fy, with a male to female ratio of 3:2', 'Patients with obstructive sleep apnea', 'patients with obstructive sleep apnea']","['fluticasone', 'intranasal fluticasone', 'intranasal corticosteroid spray']","['Nasal Obstruction Symptom Evaluation scores, Pittsburgh Sleep Quality Index questionnaire and Epworth Sleepiness Scale questionnaire', 'Nasal Obstruction Symptom', 'post-treatment Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, and Nasal Obstruction Symptom Evaluation scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0027429', 'cui_str': 'Nasal Airway Obstruction'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]","[{'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C4521772', 'cui_str': 'Spray'}]","[{'cui': 'C0027429', 'cui_str': 'Nasal Airway Obstruction'}, {'cui': 'C3494438', 'cui_str': 'Symptom Evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3541276', 'cui_str': 'ESS - Epworth Sleepiness Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",50.0,0.0106789,"The post-treatment Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, and Nasal Obstruction Symptom Evaluation scores all indicated a decrease compared to pre-treatment scores, from 10.4 to 8.74, 7.86 to 6.66 and 9.08 to 6.48, respectively.","[{'ForeName': 'Yuan-Yun', 'Initials': 'YY', 'LastName': 'Tam', 'Affiliation': 'Taoyuan General Hospital, Department of Otorhinolaryngology - Head and Neck Surgery, Ministry of Health and Welfare, Taoyuan City, Taiwan.'}, {'ForeName': 'I-Hung', 'Initials': 'IH', 'LastName': 'Shao', 'Affiliation': 'Chang Gung University, Linkou Chang Gung Memorial Hospital, Department of Surgery, Division of Urology, Taoyuan City, Taiwan.'}, {'ForeName': 'Chia-Chen', 'Initials': 'CC', 'LastName': 'Wu', 'Affiliation': 'Chang Gung University, Linkou Chang Gung Memorial Hospital, Department of Otorhinolaryngology - Head and Neck Surgery, Taoyuan City, Taiwan.'}, {'ForeName': 'Ming-Li', 'Initials': 'ML', 'LastName': 'Hsieh', 'Affiliation': 'Chang Gung University, Linkou Chang Gung Memorial Hospital, Department of Surgery, Division of Urology, Taoyuan City, Taiwan. Electronic address: h0810@cgmh.org.tw.'}]",Brazilian journal of otorhinolaryngology,['10.1016/j.bjorl.2019.07.007'] 546,31369124,Factorial Mendelian randomization: using genetic variants to assess interactions.,"BACKGROUND Factorial Mendelian randomization is the use of genetic variants to answer questions about interactions. Although the approach has been used in applied investigations, little methodological advice is available on how to design or perform a factorial Mendelian randomization analysis. Previous analyses have employed a 2 × 2 approach, using dichotomized genetic scores to divide the population into four subgroups as in a factorial randomized trial. METHODS We describe two distinct contexts for factorial Mendelian randomization: investigating interactions between risk factors, and investigating interactions between pharmacological interventions on risk factors. We propose two-stage least squares methods using all available genetic variants and their interactions as instrumental variables, and using continuous genetic scores as instrumental variables rather than dichotomized scores. We illustrate our methods using data from UK Biobank to investigate the interaction between body mass index and alcohol consumption on systolic blood pressure. RESULTS Simulated and real data show that efficiency is maximized using the full set of interactions between genetic variants as instruments. In the applied example, between 4- and 10-fold improvement in efficiency is demonstrated over the 2 × 2 approach. Analyses using continuous genetic scores are more efficient than those using dichotomized scores. Efficiency is improved by finding genetic variants that divide the population at a natural break in the distribution of the risk factor, or else divide the population into more equal-sized groups. CONCLUSIONS Previous factorial Mendelian randomization analyses may have been underpowered. Efficiency can be improved by using all genetic variants and their interactions as instrumental variables, rather than the 2 × 2 approach.",2020,"In the applied example, between 4- and 10-fold improvement in efficiency is demonstrated over the 2 × 2 approach.",[],[],['efficiency'],[],[],"[{'cui': 'C0013682', 'cui_str': 'Efficiency'}]",,0.0318697,"In the applied example, between 4- and 10-fold improvement in efficiency is demonstrated over the 2 × 2 approach.","[{'ForeName': 'Jessica M B', 'Initials': 'JMB', 'LastName': 'Rees', 'Affiliation': 'Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Christopher N', 'Initials': 'CN', 'LastName': 'Foley', 'Affiliation': 'MRC Biostatistics Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Burgess', 'Affiliation': 'Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}]",International journal of epidemiology,['10.1093/ije/dyz161'] 547,19386052,Protective effect of interval exercise on psychophysiological stress reactivity in children.,"Two studies determined whether interval exercise reduces children's stress reactivity. For Experiment 1 children completed interval exercise (n=14) or watched TV (n=14) for 25 min. After 20 min rest children completed a speech task. Speech-induced diastolic blood pressure (DBP) reactivity was dampened in the exercise group (p<.05). For Experiment 2 children (n=22) completed interval exercise-speech and TV-speech conditions on separate days. Physical activity was assessed by accelerometry and aerobic fitness estimated by submaximal exercise. DBP, systolic BP, and heart rate (HR) reactivity to the speech stressor were dampened (p<.05) after exercise compared to TV watching. Fitness was positively associated with HR reactivity. Interval exercise that mimics usual patterns of physically active play dampens cardiovascular reactivity to interpersonal stress.",2009,Speech-induced diastolic blood pressure (DBP) reactivity was dampened in the exercise group (p<.05).,['children'],['interval exercise'],"['HR reactivity', 'Physical activity', 'Speech-induced diastolic blood pressure (DBP) reactivity', 'psychophysiological stress reactivity', 'interval exercise-speech and TV-speech conditions', 'DBP, systolic BP, and heart rate (HR) reactivity', ""children's stress reactivity""]","[{'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",,0.027488,Speech-induced diastolic blood pressure (DBP) reactivity was dampened in the exercise group (p<.05).,"[{'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Roemmich', 'Affiliation': 'Division of Behavioral Medicine, Department of Pediatrics, University at Buffalo School of Medicine and Biomedical Sciences, Buffalo, New York 14214-3000, USA. roemmich@buffalo.edu'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Lambiase', 'Affiliation': ''}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Salvy', 'Affiliation': ''}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Horvath', 'Affiliation': ''}]",Psychophysiology,['10.1111/j.1469-8986.2009.00808.x'] 548,32427792,Comparison of Silicone Sheets and Paper Tape for the Management of Postoperative Scars: A Randomized Comparative Study.,"OBJECTIVE To compare the effectiveness of silicone sheets and paper tape in the prevention of postoperative cesarean section scars. METHODS Patients undergoing horizontal cesarean section were included in this randomized controlled trial. Surgical wounds were divided into two halves. Patients randomly applied silicone sheets or paper tape to each side of their wound as assigned for 3 months. Wounds were assessed at 1, 3, 6, and 12 months after surgery. Researchers used the objective Vancouver Scar Scale (VSS) to evaluate the scars and the subjective visual analog scale (VAS) to evaluate itch, pain, and scar appearance. RESULTS No significant differences between the silicone sheet and paper tape groups were noted at postoperative follow-ups with respect to VSS scores. The silicone sheet group had significantly better VAS scores for scar appearance than the paper tape group at 6 (6.81 ± 1.47 vs 6.19 ± 1.62, P = .03) and 12 (6.88 ± 2.01 vs 6.2 ± 2.08, P = .04) months' follow-up, respectively. CONCLUSIONS The silicone sheet group showed statistically significant differences in comparison with the paper tape group in terms of scar appearance as determined by the VAS. However, the differences were too small to be clinically meaningful.",2020,No significant differences between the silicone sheet and paper tape groups were noted at postoperative follow-ups with respect to VSS scores.,"['Postoperative Scars', 'Patients undergoing horizontal cesarean section']","['silicone sheets or paper tape', 'Silicone Sheets and Paper Tape', 'silicone sheets and paper tape']","['subjective visual analog scale (VAS) to evaluate itch, pain, and scar appearance', 'scar appearance', 'VAS scores for scar appearance', 'objective Vancouver Scar Scale (VSS']","[{'cui': 'C0334150', 'cui_str': 'Surgical scar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0439643', 'cui_str': 'Sheets'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0228907,No significant differences between the silicone sheet and paper tape groups were noted at postoperative follow-ups with respect to VSS scores.,"[{'ForeName': 'Ying-Sheng', 'Initials': 'YS', 'LastName': 'Lin', 'Affiliation': 'Ying-Sheng Lin, MD, MPH, is a resident; Pei-San Ting, MSc, is a research assistant; and Kuei-Chang Hsu, MD, is Attending Physician, Division of Plastic and Reconstructive Surgery, Kaohsiung Veterans General Hospital, Taiwan. Acknowledgments: The authors appreciate the support and cooperation of the patients in this study, who were referred by Dr Wen-Shiung Liou, Dr Fu-Nan Cho, Dr San-Nung Chen, Dr Kuan-Hao Tsui, and Dr Ju-Yueh Li in the Department of Obstetrics and Gynecology. A version of this article was presented at the Annual Meeting of the American Society of Plastic Surgery in Los Angeles, California, in September 2016. The authors have disclosed no financial relationships related to this article. Submitted March 28, 2017; accepted in revised form December 19, 2017.'}, {'ForeName': 'Pei-San', 'Initials': 'PS', 'LastName': 'Ting', 'Affiliation': ''}, {'ForeName': 'Kuei-Chang', 'Initials': 'KC', 'LastName': 'Hsu', 'Affiliation': ''}]",Advances in skin & wound care,['10.1097/01.ASW.0000661932.67974.7d'] 549,31687932,A randomised trial of sheathless versus conventional access for transradial interventions.,,2021,,[],[],[],[],[],[],,0.192769,,"[{'ForeName': 'Dirk Jan', 'Initials': 'DJ', 'LastName': 'van der Heijden', 'Affiliation': 'Department of Cardiology, Haaglanden Medical Center, The Hague, the Netherlands.'}, {'ForeName': 'Maarten A H', 'Initials': 'MAH', 'LastName': 'van Leeuwen', 'Affiliation': ''}, {'ForeName': 'Stijn L', 'Initials': 'SL', 'LastName': 'Brinckman', 'Affiliation': ''}, {'ForeName': 'Maribel I', 'Initials': 'MI', 'LastName': 'Madera Cambero', 'Affiliation': ''}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Aipassa', 'Affiliation': ''}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Vart', 'Affiliation': ''}, {'ForeName': 'Robert-Jan M', 'Initials': 'RM', 'LastName': 'van Geuns', 'Affiliation': ''}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-19-00380'] 550,17653588,Minimally invasive video-assisted thyroidectomy for small follicular thyroid nodules.,"Minimal access surgery in the thyroid compartment has evolved considerably over the past 10 years and now takes many forms. This study examined the feasibility and reliability of minimally invasive thyroid surgery for the management of small benign thyroid lesions. A total of 68 patients with small thyroid nodules admitted to the Oncology Center of Mansoura University, Egypt, were enrolled in this prospective randomized trial. Patients were allotted to one of two procedures: minimally invasive video-assisted thyroidectomy (MIVAT) or minimally invasive open thyroidectomy using the Sofferman technique of strap muscle transection. Exclusion criteria were nodules > 4 cm, presence of thyroiditis, and thyroid gland volume > 20 ml. Preoperative diagnosis, operating time, blood loss, postoperative pain, complications, and cosmetic outcome were all evaluated. The MIVAT group included 35 patients, and the Sofferman group included 33 patients. The main preoperative pathology was a benign follicular lesion (70.5%), and the main postoperative final pathology was follicular adenoma (54.4%). The two groups were comparable regarding age, sex, and extent of thyroid surgery. Operating time was significantly longer in the MIVAT group (115.4 +/- 33.5 minutes) compared to the Sofferman group (65.6 +/- 23.7 minutes). The postoperative course was significantly less painful in the MIVAT group (p < 0.05). Although patients in the MIVAT group had smaller incisions (p < 0.05), the cosmetic outcome in the two groups was comparable. No long-term complication was encountered in either group. Two distinct approaches of minimally invasive thyroidectomy are now available and can be performed safely in selected patients. Despite some MIVAT advantages of less postoperative pain and slightly better cosmesis, minimally invasive open thyroidectomy offers an advantage of less operating time with comparable cosmetic results.",2007,"Although patients in the MIVAT group had smaller incisions (p < 0.05), the cosmetic outcome in the two groups was comparable.","['group included 35 patients, and the Sofferman group included 33 patients', 'small benign thyroid lesions', '68 patients with small thyroid nodules admitted to the Oncology Center of Mansoura University, Egypt', 'small follicular thyroid nodules']","['Minimally invasive video-assisted thyroidectomy', 'MIVAT', 'minimally invasive thyroid surgery', 'minimally invasive thyroidectomy', 'minimally invasive video-assisted thyroidectomy (MIVAT) or minimally invasive open thyroidectomy using the Sofferman technique of strap muscle transection']","['postoperative course', 'smaller incisions', 'cosmetic outcome', 'Preoperative diagnosis, operating time, blood loss, postoperative pain, complications, and cosmetic outcome', 'Operating time']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0154141', 'cui_str': 'Toxic uninodular goiter with thyrotoxic crisis (disorder)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0013715', 'cui_str': 'Arab Republic of Egypt'}, {'cui': 'C0439682', 'cui_str': 'Follicular (qualifier value)'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0183631', 'cui_str': 'Strap, device (physical object)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0152060', 'cui_str': 'Transection (procedure)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C1318968', 'cui_str': 'Preoperative diagnosis'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",68.0,0.0182179,"Although patients in the MIVAT group had smaller incisions (p < 0.05), the cosmetic outcome in the two groups was comparable.","[{'ForeName': 'Mohamed A F', 'Initials': 'MAF', 'LastName': 'Hegazy', 'Affiliation': 'Department of Surgical Oncology, Mansoura University Hospital, El Gomhoria St., Mansoura, Egypt. mhegazy68@yahoo.com.'}, {'ForeName': 'Ashraf A', 'Initials': 'AA', 'LastName': 'Khater', 'Affiliation': 'Department of Surgical Oncology, Mansoura University Hospital, El Gomhoria St., Mansoura, Egypt.'}, {'ForeName': 'Ahmed E', 'Initials': 'AE', 'LastName': 'Setit', 'Affiliation': 'Department of Surgical Oncology, Mansoura University Hospital, El Gomhoria St., Mansoura, Egypt.'}, {'ForeName': 'Mahmoud A', 'Initials': 'MA', 'LastName': 'Amin', 'Affiliation': 'Department of General Surgery, Mansoura University Hospital, El Gomhoria St., Mansoura, Egypt.'}, {'ForeName': 'Sherif Z', 'Initials': 'SZ', 'LastName': 'Kotb', 'Affiliation': 'Department of Surgical Oncology, Mansoura University Hospital, El Gomhoria St., Mansoura, Egypt.'}, {'ForeName': 'Mohamed A El', 'Initials': 'MAE', 'LastName': 'Shafei', 'Affiliation': 'Department of Surgical Oncology, Mansoura University Hospital, El Gomhoria St., Mansoura, Egypt.'}, {'ForeName': 'Tamer F', 'Initials': 'TF', 'LastName': 'Yousef', 'Affiliation': 'Department of Surgical Oncology, Mansoura University Hospital, El Gomhoria St., Mansoura, Egypt.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Hussein', 'Affiliation': 'Department of Surgical Oncology, Mansoura University Hospital, El Gomhoria St., Mansoura, Egypt.'}, {'ForeName': 'Yousef K', 'Initials': 'YK', 'LastName': 'Shabana', 'Affiliation': 'Department of Otorhinolaryngology, Mansoura University Hospital, El Gomhoria St., Mansoura, Egypt.'}, {'ForeName': 'Ola T Abdel', 'Initials': 'OTA', 'LastName': 'Dayem', 'Affiliation': 'Departments of Anesthesia and Intensive Care, Mansoura University Hospital, El Gomhoria St., Mansoura, Egypt.'}]",World journal of surgery,['10.1007/s00268-007-9147-7'] 551,17647055,"Effect of red chili consumption on postoperative symptoms during the post-hemorrhoidectomy period: randomized, double-blind, controlled study.","The aim of this study was to determine whether there was any relation between consumption of chilies and postoperative symptoms after hemorrhoidectomy in patients with grade III or IV hemorrhoidal disease. A total of 60 patients were randomly assigned to receive antibiotics and analgesics alone (control patients) or daily consumption of 3 g of chili powder along with identical antibiotics and analgesics (chili group). The evaluation of symptoms-pain, anal burning, pruritus, bleeding-during the postoperative period was assessed by means of patients' self-questionnaires. A global score for evaluating each postoperative symptom was compared between the two groups at the 1-week follow-up. No significant difference in age, sex distribution, or grade of disease was noted between the two groups at baseline. The incidence of post-hemorrhoidectomy symptoms was higher in the group consuming chilies during the first postoperative week. The global score for postoperative pain (14.60 for the chili group vs. 7.97 for the control group, p < 0.001) and for anal burning (12.90 for the chili group vs. 7.82 for the control group, p < 0.0001) were significant. Although bleeding (6.95 in the control group and 7.57 in the chili group, p < 0.81) and pruritus (8.06 in the control group and 8.75 in the chili group, p < 0.69) were more common in the chili group, the difference did not achieve statistical significance. This study shows that consumption of 3 g of red chilies per day during the postoperative period after hemorrhoidectomy increases the intensity of typical postoperative symptoms, stool frequency, and the consumption of analgesics.",2007,The incidence of post-hemorrhoidectomy symptoms was higher in the group consuming chilies during the first postoperative week.,"['60 patients', 'patients with grade III or IV hemorrhoidal disease']","['antibiotics and analgesics alone (control patients) or daily consumption of 3 g of chili powder along with identical antibiotics and analgesics (chili group', 'red chili consumption']","['anal burning', 'global score for postoperative pain', 'intensity of typical postoperative symptoms, stool frequency, and the consumption of analgesics', 'consumption of chilies and postoperative symptoms', 'age, sex distribution, or grade of disease', 'pruritus', 'bleeding', 'incidence of post-hemorrhoidectomy symptoms', 'symptoms-pain, anal burning, pruritus, bleeding', 'postoperative symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0475622', 'cui_str': 'Chili powder'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}]","[{'cui': 'C2939124', 'cui_str': 'Anal (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0036878', 'cui_str': 'Sex Distribution'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",60.0,0.0713745,The incidence of post-hemorrhoidectomy symptoms was higher in the group consuming chilies during the first postoperative week.,"[{'ForeName': 'Pravin J', 'Initials': 'PJ', 'LastName': 'Gupta', 'Affiliation': 'Gupta Nursing Home, Laxminagar, Nagpur, 440022, India. drpjg_ngp@sancharnet.in.'}]",World journal of surgery,['10.1007/s00268-007-9148-6'] 552,17510766,Pain after open preperitoneal repair versus Lichtenstein repair: a randomized trial.,"BACKGROUND The open preperitoneal approach in inguinal hernia repair might have the benefit of a mesh in the preferred space without the disadvantages of an endoscopic procedure. METHODS A total of 172 patients with primary inguinal hernia were randomized to undergo the open preperitoneal Kugel or the standard open anterior Lichtenstein procedure in a teaching hospital. The main outcome measures were operating variables, visual analog scale (VAS) pain scores, and consumed analgesics during the first 2 weeks postoperatively and at 3 months, neurological examination, and complications. RESULTS In the Lichtenstein group the operation took longer (54 min versus 41 min; p < .001). There were no clinically important differences in VAS pain score or number of analgesics during the first 2 weeks postoperatively. In the Kugel group the mean VAS pain score at 3 months was less (0.3 versus 0.9; p = .002), as was the proportion of patients reporting pain (21 versus 40%; p = .007). Pain was merely described as neuropathic, especially in the Lichtenstein group. With the anterior repair significantly more nerves were encountered, numbness reported, and cutaneous sensory changes found with neurological examination (all p < .001). CONCLUSIONS For those surgeons preferring an open approach, the Kugel procedure is a feasible alternative for the standard Lichtenstein procedure and is associated with less chronic pain at three months. Most likely the neuropathic pain and numbness with the Lichtenstein technique are results of more nerves at risk with the anterior approach.",2007,In the Lichtenstein group the operation took longer (54 min versus 41 min; p < .001).,['172 patients with primary inguinal hernia'],"['preperitoneal repair versus Lichtenstein repair', 'open preperitoneal Kugel or the standard open anterior Lichtenstein procedure']","['proportion of patients reporting pain', 'operating variables, visual analog scale (VAS) pain scores, and consumed analgesics during the first 2 weeks postoperatively and at 3 months, neurological examination, and complications', 'Pain', 'mean VAS pain score', 'VAS pain score or number of analgesics', 'chronic pain', 'neurological examination']","[{'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0019294', 'cui_str': 'Hernia, Inguinal'}]","[{'cui': 'C0442170', 'cui_str': 'Preperitoneal approach (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0027853', 'cui_str': 'Neurological Examination'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}]",172.0,0.0996587,In the Lichtenstein group the operation took longer (54 min versus 41 min; p < .001).,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Nienhuijs', 'Affiliation': 'Department of Surgery, Canisius-Wilhelmina Hospital, Nijmegen, The Netherlands. s.nienhuijs@hccnet.nl.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Staal', 'Affiliation': 'University Medical Centre St. Radboud, PO Box 9015, 6500, GS, Nijmegen, The Netherlands.'}, {'ForeName': 'Mariël', 'Initials': 'M', 'LastName': 'Keemers-Gels', 'Affiliation': 'Department of Surgery, Canisius-Wilhelmina Hospital, Nijmegen, The Netherlands.'}, {'ForeName': 'Camiel', 'Initials': 'C', 'LastName': 'Rosman', 'Affiliation': 'Department of Surgery, Canisius-Wilhelmina Hospital, Nijmegen, The Netherlands.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Strobbe', 'Affiliation': 'Department of Surgery, Canisius-Wilhelmina Hospital, Nijmegen, The Netherlands.'}]",World journal of surgery,['10.1007/s00268-007-9090-7'] 553,32434291,Effect of preoperative dexmedetomidine nebulization on the hemodynamic response to laryngoscopy and intubation: a randomized control trial.,"BACKGROUND Dexmedetomidine, an alpha-2 agonist, has been used for attenuation of hemodynamic response to laryngoscopy but not through the nebulized route. We evaluated the effects of preoperative dexmedetomidine nebulization on the hemodynamic response to laryngoscopy and intubation and examined the intraoperative anesthetic-analgesic requirements and recovery outcomes. METHODS Overall, 120 American Society of Anesthesiologists I & II adult patients (of either gender) undergoing elective surgeries and requiring tracheal intubation, were randomized to receive nebulized dexmedetomidine (1 µg/kg in 3-4 ml of 0.9% saline) or 0.9% saline (3-4 ml), 30 min before anesthesia induction. Heart rate (HR) and non-invasive systolic blood pressure (SBP) were monitored for 10 min following laryngoscopy. RESULTS After laryngoscopy, linear mixed effect modelling showed significantly lower trend of increase in HR in the dexmedetomidine group versus saline (P = 0.012); however, there was no difference in the SBP changes between the two groups (P = 0.904). Induction dose of propofol (P < 0.001), intraoperative fentanyl consumption (P = 0.007), and isoflurane requirements (P = 0.013) were significantly lower in the dexmedetomidine group. There was no difference in the 2 h incidence of postoperative nausea and vomiting (PONV) (P = 0.612) or sore-throat (P = 0.741). CONCLUSIONS Nebulized dexmedetomidine at 1 µg/kg attenuated the increase in HR but not SBP following laryngoscopy and reduced the intraoperative anesthetic and analgesic consumption. There was no effect on early PONV, sore-throat, or increase in incidence of adverse effects. Nebulized dexmedetomidine may represent a favorable alternative to the intravenous route in short duration surgeries.",2021,"There was no difference in the 2-hr postoperative nausea and vomiting (PONV) (P = 0.61) or sore-throat (P = 0.74). ","['120 ASA I & II adult patients, of either gender, undergoing elective surgeries requiring tracheal intubation']","['nebulized dexmedetomidine (1 µg/kg in 3-4 ml of 0.9% saline) or 0.9% saline', 'Dexmedetomidine', 'Nebulized dexmedetomidine', 'dexmedetomidine nebulization', 'preoperative dexmedetomidine nebulization', 'propofol', 'dexmedetomidine']","['2-hr postoperative nausea and vomiting (PONV', 'Heart rate and non-invasive systolic blood pressures', 'early PONV, sore-throat or increase in incidence of adverse effects', 'systolic blood pressure changes', 'intraoperative anesthetic and analgesic consumption', 'heart rate', 'isoflurane requirements', 'intraoperative fentanyl consumption', 'sore-throat', 'hemodynamic response', 'systolic blood pressures']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428881', 'cui_str': 'Non-invasive systolic arterial pressure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0022180', 'cui_str': 'Isoflurane'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}]",120.0,0.289014,"There was no difference in the 2-hr postoperative nausea and vomiting (PONV) (P = 0.61) or sore-throat (P = 0.74). ","[{'ForeName': 'Satyajeet', 'Initials': 'S', 'LastName': 'Misra', 'Affiliation': 'Department of Anesthesiology & Critical Care, All India Institute of Medical Sciences, Bhubaneswar, India.'}, {'ForeName': 'Bikram Kishore', 'Initials': 'BK', 'LastName': 'Behera', 'Affiliation': 'Department of Anesthesiology & Critical Care, All India Institute of Medical Sciences, Bhubaneswar, India.'}, {'ForeName': 'Jayanta Kumar', 'Initials': 'JK', 'LastName': 'Mitra', 'Affiliation': 'Department of Anesthesiology & Critical Care, All India Institute of Medical Sciences, Bhubaneswar, India.'}, {'ForeName': 'Alok Kumar', 'Initials': 'AK', 'LastName': 'Sahoo', 'Affiliation': 'Department of Anesthesiology & Critical Care, All India Institute of Medical Sciences, Bhubaneswar, India.'}, {'ForeName': 'Sritam Swarup', 'Initials': 'SS', 'LastName': 'Jena', 'Affiliation': 'Department of Anesthesiology & Critical Care, All India Institute of Medical Sciences, Bhubaneswar, India.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Srinivasan', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences, Bhubaneswar, India.'}]",Korean journal of anesthesiology,['10.4097/kja.20153'] 554,17061753,Recruitment of black women with type 2 diabetes into a self-management intervention trial.,"The purpose of this study was to evaluate the relationship of recruitment methods to enrollment status in Black women with type 2 diabetes screened for entry into a randomized clinical trial (RCT). Using a cross-sectional study design with convenience sampling procedures, data were collected on recruitment methods to which the women responded (N=236). Results demonstrated that the RCT had a moderate overall recruitment rate of 46% and achieved only 84% of its projected accrual goal (N=109). Chi-square analysis demonstrated that enrollment outcomes varied significantly according to recruitment methods (P=.05). Recruitment methods such as community health fairs (77.8%), private practice referrals (75.0%), participant referrals (61.5%), community clinic referrals (44.6%), community advertising and marketing (40.9%), and chart review (40.4%) demonstrated variable enrollment yields. Results confirm previous findings that indicate that Black Americans may be successfully recruited into research studies at moderate rates when traditional recruitment methods are enhanced and integrated with more culturally sensitive methods. Lessons learned are considered.",2006,Chi-square analysis demonstrated that enrollment outcomes varied significantly according to recruitment methods (P=.05).,"['black women with type 2 diabetes into a self-management intervention trial', 'Black Americans', 'Black women with type 2 diabetes screened for entry into a randomized clinical trial (RCT', 'community health fairs (77.8%), private practice referrals (75.0%), participant referrals (61.5%), community clinic referrals (44.6%), community advertising and marketing (40.9%), and chart review (40.4%) demonstrated variable enrollment yields']",['RCT'],['moderate overall recruitment rate'],"[{'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C2911689', 'cui_str': 'Fair'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0587907', 'cui_str': 'Community clinic (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0024826', 'cui_str': 'Marketing'}, {'cui': 'C0541653', 'cui_str': 'Chart review'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}]",[],"[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}]",,0.255634,Chi-square analysis demonstrated that enrollment outcomes varied significantly according to recruitment methods (P=.05).,"[{'ForeName': 'Kelley', 'Initials': 'K', 'LastName': 'Newlin', 'Affiliation': 'Yale University School of Nursing, 100 Church Street South, New Haven, CT 06520, USA. kelley.newlin@yale.edu'}, {'ForeName': ""Gail D'Eramo"", 'Initials': 'GD', 'LastName': 'Melkus', 'Affiliation': ''}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Jefferson', 'Affiliation': ''}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Langerman', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Womack', 'Affiliation': ''}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Chyun', 'Affiliation': ''}]",Ethnicity & disease,[] 555,17250745,Retracted: Do patients profit from physostigmine in recovery from desflurane anaesthesia?,"BACKGROUND Physostigmine is the drug of choice in the central anticholinergic syndrome, but has also been used in post-operative mental derangement secondary to sedatives and volatile anaesthetics. The aim of this double-blind, randomized, prospective study was to determine whether physostigmine alters recovery after desflurane anaesthesia. METHODS One hundred patients undergoing urologic or surgical procedures were enrolled to receive either NaCl 0.9% (n = 50) or 2 mg of physostigmine (n = 50) at the end of general anaesthesia with propofol, fentanyl, cisatracurium and desflurane. Times to extubation, stating name, birthday and place of residence, and obeying commands such as eye opening and hand squeezing were noted. Haemodynamics, Aldrete and pain scores, the analgesic requirements, and any adverse side-effects were documented until the 1st post-operative day. RESULTS Demographic, peri-operative data including duration of anaesthesia, surgery and postanaesthetic care unit (PACU) stay, and consumption of anaesthetics were comparable in both groups. No significant difference between the groups was found for extubation time or other emergence parameters. Patients undergoing anaesthesia >150 min showed after receiving physostigmine significantly (P < 0.05) faster spontaneous breathing (2.6 +/- 3.1 vs. placebo 5.0 +/- 4.2 min) and extubation time (6.2 +/- 3.7 vs. placebo 8.8 +/- 5.0 min). Women showed significantly shorter extubation times (5.5 +/- 3.4 min) and eye opening (5.5 +/- 2.6 min) with physostigmine than placebo (7.7 +/- 4.5 and 7.8 +/- 4.0 min). The incidence of post-operative nausea and vomiting (PONV) was significantly higher after physostigmine than placebo, whereas shivering occurred more often after placebo. CONCLUSION Physostigmine does not alter desflurane-based anaesthesia compared with placebo. An option is to use physostigmine in patients with a duration of anaesthesia >150 min who profit in earlier return to spontaneous breathing and shorter extubation time.",2007,"The incidence of post-operative nausea and vomiting (PONV) was significantly higher after physostigmine than placebo, whereas shivering occurred more often after placebo. ","['patients with a duration of anaesthesia >150 min who profit in earlier return to spontaneous breathing and shorter extubation time', 'One hundred patients undergoing urologic or surgical procedures']","['Physostigmine', 'placebo', 'placebo 8.8 ', 'NaCl', 'propofol, fentanyl, cisatracurium and desflurane', 'physostigmine']","['extubation time', 'eye opening', 'incidence of post-operative nausea and vomiting (PONV', 'shivering', 'Haemodynamics, Aldrete and pain scores, the analgesic requirements, and any adverse side-effects', 'spontaneous breathing', 'shorter extubation times', 'duration of anaesthesia, surgery and postanaesthetic care unit (PACU) stay, and consumption of anaesthetics', 'Times to extubation, stating name, birthday and place of residence, and obeying commands such as eye opening and hand squeezing']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C0031849', 'cui_str': 'Physostigmine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4517882', 'cui_str': '8.8 (qualifier value)'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1096766', 'cui_str': 'Cisatracurium'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}]","[{'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0036973', 'cui_str': 'Shiverings'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002932', 'cui_str': 'Anesthetic Drugs'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]",100.0,0.139076,"The incidence of post-operative nausea and vomiting (PONV) was significantly higher after physostigmine than placebo, whereas shivering occurred more often after placebo. ","[{'ForeName': 'K D', 'Initials': 'KD', 'LastName': 'Röhm', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Klinikum Ludwigshafen, Ludwigshafen, Germany. k.d.roehm@web.de'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Riechmann', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Boldt', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Schöllhorn', 'Affiliation': ''}, {'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Piper', 'Affiliation': ''}]",Acta anaesthesiologica Scandinavica,[] 556,31845142,"Clinical Value of Multi-Slice Spiral CT Angiography, Colon Imaging, and Image Fusion in the Preoperative Evaluation of Laparoscopic Complete Mesocolic Excision for Right Colon Cancer: a Prospective Randomized Trial.","PURPOSE To evaluate the clinical value of CT angiography (CTA), CT colonography (CTC), and image fusion in the preoperative evaluation of laparoscopic complete mesocolic excision (CME) for right colon cancer. METHODS In this randomized prospective study, 80 patients undergoing laparoscopic CME for right colon cancer were randomly divided into two groups: image fusion [the original images were reconstructed using CTA and CTC, then fused into three-dimensional images of the blood vessels and intestines (n = 40)] and control (without CTA and CTC reconstruction before surgery). All patients underwent plain and enhanced abdominal CT before surgery. RESULTS In the image fusion group, the gastrocolic trunk of Henle was present in 33 cases, and its branches originated from the colon vein, right gastroepiploic vein, and superior anterior pancreaticoduodenal vein. Among these patients, 5 exhibited the right gastroepiploic vein and superior anterior pancreaticoduodenal vein; 21 exhibited a gastrointestinal trunk consisting of 2 or 3 branches of the right gastroepiploic vein, right colon vein, and middle colon vein; and 7 exhibited 3 or 4 gastro-pancreatic and colon trunks consisting of the right colon vein, middle colon vein, right gastroepiploic vein, and superior anterior pancreaticoduodenal vein. The correspondence with the anatomy actually observed during surgery was 100%. Compared with the conventional CT group, the duration of the operation in the image fusion group was shorter, with reduced intraoperative bleeding, and more lymph node dissection. There were no significant differences in the incidence of complications and length of hospital stay between the two groups (p > 0.05). CONCLUSIONS For laparoscopic CME for right colon cancer, CTA, CTC, and image fusion were effective preoperative evaluation methods, which avoided some unseen dangers in the operation process and led to better therapeutic outcomes.",2020,"There were no significant differences in the incidence of complications and length of hospital stay between the two groups (p > 0.05). ","['80 patients undergoing', 'Right Colon Cancer', 'for right colon cancer']","['plain and enhanced abdominal CT', 'Laparoscopic Complete Mesocolic Excision', 'laparoscopic complete mesocolic excision (CME', 'Multi-Slice Spiral CT Angiography, Colon Imaging, and Image Fusion', 'conventional CT', 'control (without CTA and CTC reconstruction before surgery', 'CT angiography (CTA), CT colonography (CTC', 'laparoscopic CME']","['reduced intraoperative bleeding, and more lymph node dissection', 'incidence of complications and length of hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305188', 'cui_str': 'Right colon structure'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0860888', 'cui_str': 'CT Scan, Spiral'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1536105', 'cui_str': 'Angiography, CT'}, {'cui': 'C0935912', 'cui_str': 'CT Colonography'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0079027', 'cui_str': 'Hemorrhage, Surgical'}, {'cui': 'C0242382', 'cui_str': 'Lymph Node Dissection'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",80.0,0.0196454,"There were no significant differences in the incidence of complications and length of hospital stay between the two groups (p > 0.05). ","[{'ForeName': 'Linjie', 'Initials': 'L', 'LastName': 'Bian', 'Affiliation': ""Department of Radiology, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, 68 Zhongshan Road, Jiangsu, 214002, People's Republic of China.""}, {'ForeName': 'Danping', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': ""Department of Radiology, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, 68 Zhongshan Road, Jiangsu, 214002, People's Republic of China.""}, {'ForeName': 'Yigang', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Department of General Surgery, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, 68 Zhongshan Road, Jiangsu, 214002, People's Republic of China. wuxichen2512@njmu.edu.cn.""}, {'ForeName': 'Zhuiyang', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ""Department of Radiology, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, 68 Zhongshan Road, Jiangsu, 214002, People's Republic of China.""}, {'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'Ni', 'Affiliation': ""Department of Radiology, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, 68 Zhongshan Road, Jiangsu, 214002, People's Republic of China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Radiology, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, 68 Zhongshan Road, Jiangsu, 214002, People's Republic of China.""}, {'ForeName': 'Jiazen', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': ""Department of General Surgery, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, 68 Zhongshan Road, Jiangsu, 214002, People's Republic of China.""}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-019-04460-1'] 557,32034028,"Effects of switching from a dipeptidyl peptidase-4 inhibitor to luseogliflozin on nocturnal blood pressure in patients with type 2 diabetes: protocol for a multicentre, prospective, randomised, open-label, blinded endpoint parallel-group comparison study.","INTRODUCTION Nocturnal hypertension is clinically important for patients with type 2 diabetes (T2D), considering its strong correlation with cardiovascular events. We aim to test the hypothesis that the sodium-glucose cotransporter 2 inhibitor, luseogliflozin, ameliorates nocturnal hypertension more effectively than a dipeptidyl peptidase (DPP)-4 inhibitor in patients with T2D. METHODS AND ANALYSIS This study is a multicentre, prospective, randomised, open-label, blinded endpoint parallel-group trial. Sixty participants with T2D and hypertension who have been treated with a DPP-4 inhibitor for more than 4 weeks and who have a glycated haemoglobin A1c (HbA1c) level of 6.0%-9.0% will be randomised based on age, body mass index (BMI) and HbA1c to continue taking their DPP-4 inhibitor or to switch to luseogliflozin 2.5 mg once daily for 8 weeks. Twenty-four-hour ambulatory blood pressure monitoring (ABPM) will be performed twice at baseline and at the end of the study. All participants will continue their diet and exercise therapy, and the doses of concomitant medications will not be adjusted during the study. The primary endpoint is the effect of luseogliflozin on the mean change in systolic blood pressure (SBP) during the night, as measured by ABPM. The secondary endpoints are mean change in diastolic blood pressure (DBP) during the night, 24 hours of SBP and DBP, daytime SBP and DBP, pulse rate, BP M-value, trough SBP and DBP for 1 hour before the next dose, and other laboratory parameters. The sample size was calculated for a two-sided test at 90% power for the detection of a difference between treatments. ETHICS AND DISSEMINATION The Ethics Review Board of Hokkaido University Hospital has approved the protocol. The results will be disseminated in peer-reviewed journals and at scientific conferences. TRIAL REGISTRATION NUMBERS The University Hospital Medical Information Network (UMIN000031451); Japan Registry of Clinical Trials (jRCTs011180019); Pre-results.",2020,"The sample size was calculated for a two-sided test at 90% power for the detection of a difference between treatments. ","['patients with T2D.\nMETHODS AND', 'patients with type 2 diabetes (T2D', 'Sixty participants with T2D and hypertension who have been treated with a DPP-4 inhibitor for more than 4 weeks and who have a glycated haemoglobin A1c (HbA1c) level of 6.0%-9.0% will be randomised based on age, body mass index (BMI) and HbA1c to continue taking their', 'patients with type 2 diabetes']","['sodium-glucose cotransporter 2 inhibitor, luseogliflozin', 'luseogliflozin', 'dipeptidyl peptidase-4 inhibitor to luseogliflozin', 'DPP-4 inhibitor or to switch to luseogliflozin 2.5\u2009mg once daily for 8 weeks']","['mean change in diastolic blood pressure (DBP) during the night, 24 hours of SBP and DBP, daytime SBP and DBP, pulse rate, BP M-value, trough SBP and DBP for 1\u2009hour before the next dose, and other laboratory parameters', 'ambulatory blood pressure monitoring (ABPM', 'mean change in systolic blood pressure (SBP', 'nocturnal blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2933904', 'cui_str': '1,5-anhydro-1-(5-(4-ethoxybenzyl)-2-methoxy-4-methylphenyl)-1-thioglucitol'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl-Peptidase 4 Inhibitors'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0232117', 'cui_str': 'Pulse Rate'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0242876', 'cui_str': 'Blood Pressure Monitoring, Ambulatory'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",60.0,0.0678005,"The sample size was calculated for a two-sided test at 90% power for the detection of a difference between treatments. ","[{'ForeName': 'Reina', 'Initials': 'R', 'LastName': 'Kameda', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nomoto', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Kyu Yong', 'Initials': 'KY', 'LastName': 'Cho', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Kawata', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Kazuno', 'Initials': 'K', 'LastName': 'Omori', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Takeuchi', 'Affiliation': 'Sapporo Diabetes and Thyroid Clinic, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'So', 'Initials': 'S', 'LastName': 'Nagai', 'Affiliation': 'Division of Diabetes and Endocrinology, Department of Medicine, Sapporo Medical Centre, NTT East Corporation, Sapporo, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Kurihara', 'Affiliation': 'Kurihara Clinic, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Aoki', 'Affiliation': 'Aoki Clinic, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Akinobu', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Atsumi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Miyoshi', 'Affiliation': 'Division of Diabetes and Obesity, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Hokkaido, Japan hmiyoshi@med.hokudai.ac.jp.'}]",BMJ open,['10.1136/bmjopen-2019-034883'] 558,31845141,Laparoscopic Versus Open Emergent Sigmoid Resection for Perforated Diverticulitis.,"BACKGROUND Potential advantages of laparoscopic sigmoidectomy for perforated diverticulitis are still under consideration. This study is designed to determine if emergent laparoscopic sigmoidectomy for perforated diverticulitis is associated with outcomes comparable to the traditional open approach. METHODS The American College of Surgeons-National-Surgical-Quality-Improvement-Program (ACS-NSQIP) database was queried for laparoscopic and open emergent sigmoidectomy cases for perforated diverticulitis from 2012 through 2017. Using propensity score weights, 30-day outcomes between laparoscopic and open approaches were compared in two ways: one with converted cases as a separate group and another with converted cases combined with the laparoscopic-completed group (intention-to-treat). RESULTS A total of 3756 cases met inclusion criteria-282 laparoscopic-completed, 175 laparoscopic-converted-to-open, and 3299 open. The laparoscopic-completed approach had significantly better outcomes than open and laparoscopic-converted cases. When combining laparoscopic-completed and laparoscopic-converted cases (intention-to-treat), the laparoscopic approach still had significantly fewer complications per patient, less unplanned intubation (p = 0.01), and acute renal failure (p = 0.005) than the open group. Laparoscopic groups had longer operating times and shorter hospital length of stay than the open group. Subgroup analysis comparing laparoscopic and open Hartmann's procedure and primary anastomosis with and without diverting stoma also showed favorable outcomes for the laparoscopic group. CONCLUSIONS Laparoscopic emergent sigmoid resection for perforated diverticulitis is associated with favorable outcomes compared to the open approach. Hartmann's procedure is still common and conversion rate is high. Training efforts that increase adoption of minimally invasive surgery and decrease conversion rates are justified. Randomized trials comparing laparoscopic and open approaches may allow further critical assessment of these findings.",2020,Laparoscopic groups had longer operating times and shorter hospital length of stay than the open group.,"['The American College of Surgeons-National-Surgical-Quality-Improvement-Program (ACS-NSQIP) database was queried for laparoscopic and open emergent sigmoidectomy cases for perforated diverticulitis from 2012 through 2017', '3756 cases met inclusion criteria-282 laparoscopic-completed, 175 laparoscopic-converted-to-open, and 3299 open']","['Laparoscopic', 'Laparoscopic emergent sigmoid resection', 'laparoscopic-completed group (intention-to-treat', 'Laparoscopic Versus Open Emergent Sigmoid Resection', ""laparoscopic and open Hartmann's procedure and primary anastomosis with and without diverting stoma"", 'laparoscopic sigmoidectomy', 'laparoscopic']","['unplanned intubation', 'longer operating times and shorter hospital length of stay', 'acute renal failure']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C3543841', 'cui_str': 'Query'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0192866', 'cui_str': 'Sigmoid colectomy (procedure)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0544794', 'cui_str': 'Perforated diverticulitis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4517605', 'cui_str': '175'}]","[{'cui': 'C0227391', 'cui_str': 'Sigmoid'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0400084', 'cui_str': 'Hartmann operation, rectal resection (procedure)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C1955856', 'cui_str': 'Surgical Stoma'}, {'cui': 'C0192866', 'cui_str': 'Sigmoid colectomy (procedure)'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C3854173', 'cui_str': 'Pre-renal acute kidney injury'}]",175.0,0.0810537,Laparoscopic groups had longer operating times and shorter hospital length of stay than the open group.,"[{'ForeName': 'Yongjin F', 'Initials': 'YF', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, St Joseph Mercy Hospital, 4201 Varsity Dr suite a, Ann Arbor, MI, 48108, USA.'}, {'ForeName': 'Rebecca F', 'Initials': 'RF', 'LastName': 'Brown', 'Affiliation': 'Department of Surgery, St Joseph Mercy Hospital, 4201 Varsity Dr suite a, Ann Arbor, MI, 48108, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Battaglia', 'Affiliation': 'Biostatistics and Epidemiology Methods Consulting, BEMC, LLC, Ann Arbor, MI, 48108, USA.'}, {'ForeName': 'Robert K', 'Initials': 'RK', 'LastName': 'Cleary', 'Affiliation': 'Department of Surgery, St Joseph Mercy Hospital, 4201 Varsity Dr suite a, Ann Arbor, MI, 48108, USA. Robert.Cleary@stjoeshealth.org.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-019-04490-9'] 559,32032231,"Maximal Strength, Muscle Activation, and Bar Velocity Comparisons Between Squatting With a Traditional or Safety Squat Bar.","ABSTRACT Vantrease, WC, Townsend, JR, Sapp, PA, Henry, RN, and Johnson, KD. Maximal strength, muscle activation, and bar velocity comparisons between squatting with a traditional or safety squat bar. J Strength Cond Res 35(2S): S1-S5, 2021-The purpose of this study was to compare strength, muscle activation, and bar velocity between the traditional (TRAD) and safety squat bar (SSB) back squat. Thirty-two men (21.94 ± 3.1 years, 1.78 ± 0.8 m, 81.7 ± 10.1 kg) volunteered to complete this randomized, crossover-design study. Subjects completed 2 separate 1 repetition maximum (1RM) sessions using either the TRAD or SSB. Subsequently, subjects completed 1 session of 3 repetitions at 65 and 85% of their 1RM for each squat condition (SSB & TRAD). Peak muscle activation of 7 muscles from the lower body and trunk was recorded through surface electromyography (EMG), and mean velocity (MV) was recorded by a linear transducer. Electromyography and MV were analyzed by a 2 × 2 (bar × load) repeated-measures analysis of variance. A Pearson correlation was used to determine the relationship of 1RM load between bars. Squat 1RM was significantly higher (p < 0.001; 11.6%) for TRAD (144.7 kg) compared with SSB (128.8 kg), and a strong correlation (r = 0.94) was observed between 1RM values of each bar. A significant main effect was seen in EMG (p < 0.001) and MV for load (p < 0.001). No significant bar × load interaction was observed between conditions for any EMG or bar velocity measure (p > 0.05). The SSB produces similar muscle activation and bar velocities compared with the TRAD at relative intensities. However, absolute loads should be adjusted when changing squat bars during a training cycle.",2021,No significant bar × load interaction was observed between conditions for any EMG or bar velocity measure (p > 0.05).,"['Thirty-two men (21.94 ± 3.1 years, 1.78 ± 0.8 m, 81.7 ± 10.1 kg) volunteered']",['J Strength Cond Res XX(X'],"['load interaction', 'Electromyography and MV', 'surface electromyography (EMG), and mean velocity (MV', 'muscle activation and bar velocities', 'Vantrease, WC, Townsend, JR, Sapp, PA, Henry, RN, and Johnson, KD', 'EMG or bar velocity measure', 'EMG', 'Maximal strength, muscle activation, and bar velocity comparisons', 'Squat 1RM', 'Maximal Strength, Muscle Activation, and Bar Velocity Comparisons', 'strength, muscle activation, and bar velocity between the traditional (TRAD) and safety squat bar (SSB) back squat']","[{'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517683', 'cui_str': '3.1 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]",[],"[{'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0430815', 'cui_str': 'Surface Electromyography'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0993613', 'cui_str': 'Bar (basic dose form)'}, {'cui': 'C0582517', 'cui_str': 'henry (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0312957,No significant bar × load interaction was observed between conditions for any EMG or bar velocity measure (p > 0.05).,"[{'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Vantrease', 'Affiliation': 'Exercise and Nutrition Science Graduate Program, Lipscomb University, Nashville, Tennessee.'}, {'ForeName': 'Jeremy R', 'Initials': 'JR', 'LastName': 'Townsend', 'Affiliation': ''}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Sapp', 'Affiliation': ''}, {'ForeName': 'Ruth N', 'Initials': 'RN', 'LastName': 'Henry', 'Affiliation': ''}, {'ForeName': 'Kent D', 'Initials': 'KD', 'LastName': 'Johnson', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003541'] 560,14504728,Do different mattresses affect the quality of cardiopulmonary resuscitation?,"OBJECTIVE To determine the effect of different mattresses on cardiopulmonary resuscitation performance and establish whether emergency deflation of an inflatable mattress improves the quality of resuscitation. DESIGN AND SETTING Randomised controlled cross-over trial performed in a general ICU PARTICIPANTS: Critical care staff from a general ICU. INTERVENTIONS Cardiopulmonary resuscitation on a manikin on the floor or on a bed with a standard foam mattress and inflated and deflated pressure redistributing mattresses. Maximal compression force was measured at different bed heights. MEASUREMENTS AND RESULTS Compression depth, duty cycle and rate and percentage correct expired air ventilation were recorded on a manikin. Compression depth was significantly lower on the foam (35.2 mm), inflated (37.2 mm) and deflated mattress (39.1 mm) than the floor (44.2 mm). There were no clinically important differences in duty cycle or compression rate. The quality of ventilation was poor on all surfaces. Maximal compression force declined as bed height increased. CONCLUSIONS Resuscitation performance is adversely affected when performed on a bed (irrespective of mattress type) compared to the floor. There were no differences between the inflated and deflated mattresses, although the deflation process did not adversely affect performance. This study does not support the routine deflation of an inflated mattress during resuscitation and questions the potential benefits from using a backboard. The finding that bed height affects maximal compression forces, challenges the recommendation that cardiopulmonary resuscitation be performed with the bed at middle-thigh level and requires further investigation.",2003,"Compression depth was significantly lower on the foam (35.2 mm), inflated (37.2 mm) and deflated mattress (39.1 mm) than the floor (44.2 mm).",[],[],"['quality of ventilation', 'Compression depth', 'Maximal compression force', 'quality of resuscitation', 'duty cycle or compression rate', 'Compression depth, duty cycle and rate and percentage correct expired air ventilation']",[],[],"[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0419049', 'cui_str': 'Expired air ventilation (procedure)'}]",,0.0241229,"Compression depth was significantly lower on the foam (35.2 mm), inflated (37.2 mm) and deflated mattress (39.1 mm) than the floor (44.2 mm).","[{'ForeName': 'Gavin D', 'Initials': 'GD', 'LastName': 'Perkins', 'Affiliation': 'Department of Intensive Care Medicine, Birmingham Heartlands Hospital, Birmingham, B9\xa05SS, UK. Gavin.Perkins@heartsol.wmids.nhs.uk.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Benny', 'Affiliation': 'Leicester Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Giles', 'Affiliation': 'Department of Intensive Care Medicine, Birmingham Heartlands Hospital, Birmingham, B9\xa05SS, UK.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Gao', 'Affiliation': 'Department of Intensive Care Medicine, Birmingham Heartlands Hospital, Birmingham, B9\xa05SS, UK.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Tweed', 'Affiliation': 'Leicester Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.'}]",Intensive care medicine,['10.1007/s00134-003-2014-6'] 561,31767474,Local and regional treatment response by 18 FDG-PET-CT-scans 4 weeks after concurrent hypofractionated chemoradiotherapy in locally advanced NSCLC.,"BACKGROUND AND PURPOSE To investigate associations of early post-treatment 18 Fluorodeoxyglucose-positron-emission-tomography (FDG-PET)-scans with local (LF), regional (RF), distant failure (DF) and overall survival (OS) in locally advanced non-small cell lung cancer (LA-NSCLC)-patients treated with concurrent chemoradiotherapy. MATERIALS AND METHODS Forty-seven stage IIIA-B NSCLC-patients included in a randomized phase II-trial (NTR2230) received 66 Gy (24x2.75 Gy) with low dose Cisplatin +/- Cetuximab. FDG-PET-scans were performed at baseline and 4 weeks post-treatment (range, 1.6-10.1). SUV max , SUV mean , metabolic tumor volume (MTV), total lesion glycolysis (TLG) and gross tumor volume were calculated separately for the primary tumor and the involved lymph nodes to generate baseline, post-treatment, and relative response metrics defined as (metric pre -metric post )/metric pre . Univariable cox regression analyses were performed to investigate associations between PET-metrics and outcomes. RESULTS Metrics resulted from the post-treatment scan and relative response were associated with outcome, but baseline metrics were not. Primary tumor metrics were stronger associated with all outcomes than lymph node metrics. Both the volumetric (TLG/MTV) and intensity (SUV max /SUV mean ) PET-metrics were associated with OS. The intensity metrics were associated with LF, while the volumetric PET-metrics were associated with RF/DF. This was in contrast to the nodal metrics, demonstrating only an association between RF and the relative response of TLG/MTV. No preference was found between PET volumetric and intensity metrics associated with outcome. CONCLUSION Early post-treatment PET-metrics are associated with treatment outcome in LA-NSCLC patients treated with chemoradiotherapy. Both volumetric and intensity PET-metrics are useful, but more for the primary tumor than for lymph nodes.",2020,Primary tumor metrics were stronger associated with all outcomes than lymph node metrics.,"['Forty-seven stage IIIA-B NSCLC-patients', 'locally advanced non-small cell lung cancer (LA-NSCLC)-patients treated with concurrent chemoradiotherapy', 'LA-NSCLC patients treated with', 'locally advanced NSCLC']","['66\u202fGy (24x2.75\u202fGy) with low dose Cisplatin\u202f', 'PET-CT-scans', 'hypofractionated chemoradiotherapy', 'Cetuximab', 'chemoradiotherapy']","['PET volumetric and intensity metrics', 'Fluorodeoxyglucose-positron-emission-tomography (FDG-PET)-scans with local (LF), regional (RF), distant failure (DF) and overall survival (OS', 'volumetric (TLG/MTV) and intensity (SUV max /SUV', 'SUV max , SUV mean , metabolic tumor volume (MTV), total lesion glycolysis (TLG) and gross tumor volume']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0457162', 'cui_str': 'Stage IIIa'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C1699633', 'cui_str': 'Positron Emission Tomography Computed Tomography'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}]","[{'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0445383', 'cui_str': 'Volumetric (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C4553797', 'cui_str': 'Fluorodeoxyglucose'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0441633'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475276', 'cui_str': 'Tumor Volume'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0017952', 'cui_str': 'Glycolysis'}, {'cui': 'C0475645', 'cui_str': 'Gross tumor volume (observable entity)'}]",18.0,0.113764,Primary tumor metrics were stronger associated with all outcomes than lymph node metrics.,"[{'ForeName': 'Judi N A', 'Initials': 'JNA', 'LastName': 'van Diessen', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'La Fontaine', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Michel M', 'Initials': 'MM', 'LastName': 'van den Heuvel', 'Affiliation': 'Department of Thoracic Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'van Werkhoven', 'Affiliation': 'Department of Biometrics, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Walraven', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Wouter V', 'Initials': 'WV', 'LastName': 'Vogel', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands; Department of Nuclear Medicine, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'José S A', 'Initials': 'JSA', 'LastName': 'Belderbos', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Jan-Jakob', 'Initials': 'JJ', 'LastName': 'Sonke', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands. Electronic address: j.sonke@nki.nl.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2019.10.008'] 562,32034912,Acoustic closed-loop stimulation during sleep improves consolidation of reward-related memory information in healthy children but not in children with attention-deficit hyperactivity disorder.,"STUDY OBJECTIVES Slow oscillations (SO) during slow-wave sleep foster the consolidation of declarative memory. Children with attention-deficit hyperactivity disorder (ADHD) display deficits in the sleep-associated consolidation of declarative memory, possibly due to an altered function of SO. The present study aimed at enhancing SO activity using closed-looped acoustic stimulation during slow-wave sleep in children with ADHD. METHODS A total of 29 male children (14 with ADHD; aged 8-12 years) participated in a double-blind, placebo-controlled study trial. Children spent two experimental nights in a sleep lab, one stimulation night and one sham night. A declarative learning task (word-pair learning) with a reward condition was used as a primary outcome. Secondary outcome variables were a procedural memory (serial reaction time) and working memory (WM; n-back) task. Encoding of declarative and procedural memory took place in the evening before sleep. After sleep, the retrieval took place followed by the n-back task. RESULTS The stimulation successfully induced SO activity during sleep in children with and without ADHD. After stimulation, only healthy children performed better on high-rewarded memory items (primary outcome). In contrast, there were indications that only children with ADHD benefitted from the stimulation with respect to procedural as well as WM performance (secondary outcome). CONCLUSIONS We were able to show that the acoustic closed-loop stimulation can be applied to enhance SO activity in children with and without ADHD. Our data indicate that SO activity during sleep interacts with subsequent memory performance (primary outcome: rewarded declarative memory; secondary outcome: procedural and WM) in children with and without ADHD.",2020,"Children with ADHD display deficits in the sleep-associated consolidation of declarative memory, possibly due to an altered function of SO.","['children with and without ADHD', 'children with ADHD', 'healthy children but not in children with ADHD', 'Twenty nine male children (14 with ADHD; aged 8-12 yrs']","['declarative learning task (word-pair learning', 'placebo', 'closed-looped acoustic stimulation', 'Acoustic closed-loop stimulation']","['procedural memory (serial reaction time) and working memory (n-back) task', 'SO activity', 'declarative memory, secondary outcome: procedural and working memory']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0870221', 'cui_str': 'Boys'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001164', 'cui_str': 'Stimulation, Auditory'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0561782', 'cui_str': 'Procedural memory (observable entity)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",29.0,0.082638,"Children with ADHD display deficits in the sleep-associated consolidation of declarative memory, possibly due to an altered function of SO.","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Prehn-Kristensen', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, Center for Integrative Psychiatry, School of Medicine, Christian-Albrechts-University, Kiel, Germany.'}, {'ForeName': 'Hong-Viet V', 'Initials': 'HV', 'LastName': 'Ngo', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Lentfer', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, Center for Integrative Psychiatry, School of Medicine, Christian-Albrechts-University, Kiel, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Berghäuser', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, Center for Integrative Psychiatry, School of Medicine, Christian-Albrechts-University, Kiel, Germany.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Brandes', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, Center for Integrative Psychiatry, School of Medicine, Christian-Albrechts-University, Kiel, Germany.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Schulze', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, Center for Integrative Psychiatry, School of Medicine, Christian-Albrechts-University, Kiel, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Göder', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Center for Integrative Psychiatry, School of Medicine, Christian-Albrechts-University, Kiel, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Mölle', 'Affiliation': 'Center of Brain, Behavior and Metabolism, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Lioba', 'Initials': 'L', 'LastName': 'Baving', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, Center for Integrative Psychiatry, School of Medicine, Christian-Albrechts-University, Kiel, Germany.'}]",Sleep,['10.1093/sleep/zsaa017'] 563,31502032,Holmium laser enucleation of the prostate versus thulium laser enucleation of the prostate for the treatment of large-volume prostates > 80 ml: 18-month follow-up results.,"PURPOSE To compare the perioperative and functional outcomes of holmium laser enucleation of the prostate (HoLEP) and thulium laser enucleation of the prostate (ThuLEP) for the treatment of large-volume benign prostatic hyperplasia (BPH) (> 80 ml). METHODS A total of 116 consecutive patients with BPH were randomized to be treated surgically with either HoLEP (n = 58) or ThuLEP (n = 58), following the classical three-lobe enucleation technique. Follow-up was assessed at 1, 3, 6, 12 and 18 months after surgery. RESULTS At 18 months, the lower urinary tract symptom index was improved significantly in both groups compared with the baseline values. The operative time (78.4 ± 8.0 vs. 71.4 ± 6.4 min) and enucleation time (61.2 ± 5.4 vs. 56.4 ± 8.4 min) were significantly shorter for ThuLEP compared to HoLEP (both p < 0.001). There were no significant differences between the two groups regarding morcellation time, resected weight, hemoglobin decrease, catheter time and hospital stay (p > 0.05). The HoLEP and ThuLEP groups had equivalent International Prostate Symptom Scores (3 [3-3] vs. 3 [3-3], p = 0.776), quality of life (1 [1-2] vs. 2 [1-2], p = 0.809), Qmax (25.3 ± 4.8 ml/s vs. 24.7 ± 4.4 ml/s, p = 0.470), postvoid residual urine (PVR) (6.1 [2.6-20.8] vs. 7.7 [3.1-22.8] ml, p = 0.449) and PSA (0.84 ± 0.32 vs. 0.90 ± 0.34 ml, p = 0.309) at 18 months postoperatively. CONCLUSION Both HoLEP and ThuLEP relieve lower urinary tract symptoms in a comparable way with high efficacy and safety. ThuLEP was statistically superior to HoLEP in operation time and enucleation time, although the differences were clinically negligible.",2020,"There were no significant differences between the two groups regarding morcellation time, resected weight, hemoglobin decrease, catheter time and hospital stay (p > 0.05).","['large-volume prostates\u2009', 'large-volume benign prostatic hyperplasia (BPH) (>\u200980\xa0ml', '116 consecutive patients with BPH']","['Holmium laser enucleation of the prostate versus thulium laser enucleation', 'HoLEP', 'classical three-lobe enucleation technique', 'holmium laser enucleation of the prostate (HoLEP) and thulium laser enucleation of the prostate (ThuLEP', 'HoLEP and ThuLEP', 'ThuLEP']","['quality of life', 'postvoid residual urine (PVR', 'operative time', 'equivalent International Prostate Symptom Scores', 'enucleation time', 'urinary tract symptoms', 'lower urinary tract symptom index', 'operation time and enucleation time', 'morcellation time, resected weight, hemoglobin decrease, catheter time and hospital stay']","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C1704272', 'cui_str': 'Benign Prostatic Hyperplasia'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005001', 'cui_str': 'Benign enlargement of prostate'}]","[{'cui': 'C1955839', 'cui_str': 'Holmium Lasers'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0040066', 'cui_str': 'Thulium'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0443177', 'cui_str': 'Classical (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1293635', 'cui_str': 'Laser enucleation of the prostate'}]","[{'cui': 'C0034380'}, {'cui': 'C0278024', 'cui_str': 'Residual urine'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0042027'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0574785', 'cui_str': 'Lower Urinary Tract Symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C4042900', 'cui_str': 'Morcellation'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low (finding)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",116.0,0.0255013,"There were no significant differences between the two groups regarding morcellation time, resected weight, hemoglobin decrease, catheter time and hospital stay (p > 0.05).","[{'ForeName': 'Junjie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Xiangya Hospital, Central South University, Changsha, 410008, Hunan, China.'}, {'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Ou', 'Affiliation': 'Department of Urology, Xiangya Hospital, Central South University, Changsha, 410008, Hunan, China.'}, {'ForeName': 'Xiaobo', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Xiangya Hospital, Central South University, Changsha, 410008, Hunan, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'Department of Urology, Xiangya Hospital, Central South University, Changsha, 410008, Hunan, China.'}, {'ForeName': 'Ruizhe', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Xiangya Hospital, Central South University, Changsha, 410008, Hunan, China.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Mo', 'Affiliation': 'Department of Urology, Xiangya Hospital, Central South University, Changsha, 410008, Hunan, China.'}, {'ForeName': 'Lingxiao', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Urology, Xiangya Hospital, Central South University, Changsha, 410008, Hunan, China.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'Department of Urology, The Second Xiangya Hospital of Central South University, Changsha, 410011, Hunan, China.'}, {'ForeName': 'Shusuan', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': 'Department of Urology, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medical, Central South University, Changsha, 410013, Hunan, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': 'Department of Respiratory Medicine, Xiangya Hospital, Central South University, Changsha, 410008, Hunan, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Department of Urology, Xiangya Hospital, Central South University, Changsha, 410008, Hunan, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Xiangya Hospital, Central South University, Changsha, 410008, Hunan, China. wanglong@csu.edu.cn.'}]",World journal of urology,['10.1007/s00345-019-02945-x'] 564,14557857,Alcohol withdrawal severity is decreased by symptom-orientated adjusted bolus therapy in the ICU.,"OBJECTIVE To examine the effect of bolus vs. continuous infusion adjustment on severity and duration of alcohol withdrawal syndrome (AWS), the medication requirements for AWS treatment, and the effect on ICU stay in surgical intensive care unit (ICU) patients. DESIGN AND SETTING Prospective randomized, double-blind controlled trial in a surgical ICU. PATIENTS 44 patients who developed AWS after admission to the ICU. INTERVENTIONS Patients were randomized to either (a). a continuous infusion course of intravenous flunitrazepam (agitation), intravenous clonidine (sympathetic hyperactivity), and intravenous haloperidol (productive psychotic symptoms) if needed (infusion-titrated group), or (b). the same medication (flunitrazepam, clonidine, or haloperidol) bolus adjusted in response to the development of the signs and symptoms of AWS (bolus-titrated group). MEASUREMENTS AND RESULTS The administration of ""as-needed"" medication was determined using a validated measure of the severity of AWS (Clinical Institute of Withdrawal Assessment). Although the severity of AWS did not differ between groups initially, it significantly worsened over time in the infusion-titrated group. This required a higher amount of flunitrazepam, clonidine, and haloperidol. ICU treatment was significantly shorter in the bolus-titrated group (median difference 6 days) due to a lower incidence of pneumonia (26% vs. 43%). CONCLUSIONS We conclude that symptom-orientated bolus-titrated therapy decreases the severity and duration of AWS and of medication requirements, with clinically relevant benefits such as fewer days of ventilation, lower incidence of pneumonia, and shorter ICU stay.",2003,"ICU treatment was significantly shorter in the bolus-titrated group (median difference 6 days) due to a lower incidence of pneumonia (26% vs. 43%). ","['surgical intensive care unit (ICU) patients', '44 patients who developed AWS after admission to the ICU']","['flunitrazepam, clonidine, or haloperidol', 'flunitrazepam (agitation), intravenous clonidine (sympathetic hyperactivity', 'flunitrazepam, clonidine, and haloperidol', 'haloperidol']","['severity and duration of alcohol withdrawal syndrome (AWS', 'pneumonia', 'incidence of pneumonia, and shorter ICU stay', 'Alcohol withdrawal severity', 'severity of AWS', 'severity and duration of AWS and of medication requirements']","[{'cui': 'C1690590', 'cui_str': 'Surgical intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]","[{'cui': 'C0016296', 'cui_str': 'Flunitrazepam'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0424295', 'cui_str': 'Increased purposeful goal-directed activity'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0236663', 'cui_str': 'Alcohol withdrawal syndrome (disorder)'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]",44.0,0.0202125,"ICU treatment was significantly shorter in the bolus-titrated group (median difference 6 days) due to a lower incidence of pneumonia (26% vs. 43%). ","[{'ForeName': 'Claudia D', 'Initials': 'CD', 'LastName': 'Spies', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, Campus Charité Mitte, Schumannstrasse 20/21, 10117, Berlin, Germany. claudia.spies@charite.de.'}, {'ForeName': 'Hilke E', 'Initials': 'HE', 'LastName': 'Otter', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, Campus Charité Mitte, Schumannstrasse 20/21, 10117, Berlin, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Hüske', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, Campus Charité Mitte, Schumannstrasse 20/21, 10117, Berlin, Germany.'}, {'ForeName': 'Pranav', 'Initials': 'P', 'LastName': 'Sinha', 'Affiliation': 'Institute of Clinical Chemistry, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Neumann', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, Campus Charité Mitte, Schumannstrasse 20/21, 10117, Berlin, Germany.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Rettig', 'Affiliation': 'School of Medicine, University of Connecticut, Conn., USA.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Lenzenhuber', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin , Berlin, Germany.'}, {'ForeName': 'Wolfgang J', 'Initials': 'WJ', 'LastName': 'Kox', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, Campus Charité Mitte, Schumannstrasse 20/21, 10117, Berlin, Germany.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Sellers', 'Affiliation': 'Departments of Pharmacology, Medicine, and Psychiatry, University of Toronto, Toronto, Ont., Canada.'}]",Intensive care medicine,['10.1007/s00134-003-2033-3'] 565,31502862,Evaluating the effect of Family Integrated Care on maternal stress and anxiety in neonatal intensive care units.,"Objective : To identify how Family Integrated Care (FICare) affected maternal stress and anxiety. Study Design : This secondary analysis of the FICare cluster randomised controlled trial included infants born between 1 April 2013 and 31 August 2015 at ≤33 weeks' gestation. Mothers completed the PSS:NICU and STAI questionnaires at enrolment and study day 21. Results : 1383 mothers completed the surveys at one or both time-points. The mean PSS:NICU and STAI scores at day 21 were significantly lower in the FICare mothers than controls (PSS:NICU mean [standard deviation] FICare 2.32 [0.75], control 2.48 [0.78], p = 0.0005; STAI FICare 70.8 [20.0], control 74.2 [19.6], p = 0.0004). The sights and sounds, looks and behaviour, and parental role PSS:NICU subscales and the state and trait STAI subscales were all significantly different between FIC are and controls at day 21. The magnitude of change in all stress and anxiety subscales was greater in the FICare group than controls. These differences remained significant after adjustment for confounders with the greatest change in the parental role (least-squares mean [95% confidence interval] FICare -0.65 [-0.72, 0.57], control -0.31 [-0.38, -0.24], p < 0.0001) and state anxiety subscales. Conclusion : FICare is effective at reducing NICU-related maternal stress and anxiety.",2021,The mean PSS:NICU and STAI scores at day 21 were significantly lower in the FICare mothers than controls (PSS:NICU mean [standard deviation],"[""infants born between 1 April 2013 and 31 August 2015 at ≤33 weeks' gestation"", 'neonatal intensive care units', '1383 mothers completed the surveys at one or both time-points']","['Family Integrated Care (FICare', 'Family Integrated Care']","['stress and anxiety subscales', 'maternal stress and anxiety', 'sights and sounds, looks and behaviour, and parental role PSS:NICU subscales and the state and trait STAI subscales', 'state anxiety subscales', 'mean PSS:NICU and STAI scores']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",1383.0,0.0718728,The mean PSS:NICU and STAI scores at day 21 were significantly lower in the FICare mothers than controls (PSS:NICU mean [standard deviation],"[{'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Cheng', 'Affiliation': 'Department of Paediatrics, Sinai Health System , Toronto, Ontario, Canada.'}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'Franck', 'Affiliation': 'Family Health Care Nursing, University of California San Francisco , San Francisco, CA, USA.'}, {'ForeName': 'Xiang Y', 'Initials': 'XY', 'LastName': 'Ye', 'Affiliation': 'Maternal-Infant Care Research Centre, Mount Sinai Hospital , Toronto, Ontario, Canada.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Hutchinson', 'Affiliation': 'Maternal-Infant Care Research Centre, Mount Sinai Hospital , Toronto, Ontario, Canada.'}, {'ForeName': 'Shoo K', 'Initials': 'SK', 'LastName': 'Lee', 'Affiliation': 'Department of Paediatrics, Sinai Health System , Toronto, Ontario, Canada.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Paediatrics, Sinai Health System , Toronto, Ontario, Canada.'}]",Journal of reproductive and infant psychology,['10.1080/02646838.2019.1659940'] 566,32436182,Lower serum bicarbonate is associated with an increased risk of acute kidney injury.,"BACKGROUND Lower serum bicarbonate levels are associated with an increased risk of kidney disease progression. Whether lower serum bicarbonate levels are associated with an increased risk of developing acute kidney injury (AKI) is unclear. METHODS We included 8393 patients from the Systolic Blood Pressure Intervention Trial (SPRINT) that had baseline serum bicarbonate levels and complete data available. AKI was a predetermined adjudicated adverse event that was determined by hospital admission and discharge records with AKI as a recorded diagnosis. Serum bicarbonate was examined in clinically significant cutoffs ≤ 24, 25-28 and > 28 mEq/L, with 25-28 mEq/L as the reference group. Cox proportional hazard models were used to examine the association between serum bicarbonate and development of AKI. RESULTS The mean (SD) age, estimated glomerular filtration rate (eGFR), and serum bicarbonate level at baseline were 68 (9) years, 77 (23) ml/min/1.73m 2 and 26.3 (2.6) mEq/L, respectively. Participants with serum bicarbonate levels ≤ 24 mEq/L were more likely to be male and to have lower baseline eGFR. After a median follow-up time of 3.3 years, 293 participants developed AKI. More patients in the lower bicarbonate group developed AKI (6.1% vs 2.8% in the 25-28 mEq/L and 2.1% in the > 28 mEq/L). A bicarbonate level ≤ 24 mEq/L was associated with a significantly increased risk of AKI compared to those with a bicarbonate level of 25-28 mEq/L after full adjustment (HR 1.42, 95% CI 1.1-1.8). CONCLUSION Lower serum bicarbonate levels are an independent risk factor for the development of AKI.",2021,More patients in the lower bicarbonate group developed AKI (6.1% vs 2.8% in the 25-28 mEq/L and 2.1% in the > ,"['8393 patients from the Systolic Blood Pressure Intervention Trial (SPRINT) that had baseline serum bicarbonate levels and complete data available', 'Participants with serum bicarbonate levels']",['bicarbonate'],"['AKI', 'Serum bicarbonate', 'risk of AKI', 'Lower serum bicarbonate levels', 'mean (SD) age, estimated glomerular filtration rate (eGFR), and serum bicarbonate level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]","[{'cui': 'C0005367', 'cui_str': 'Bicarbonate'}]","[{'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]",8393.0,0.0971515,More patients in the lower bicarbonate group developed AKI (6.1% vs 2.8% in the 25-28 mEq/L and 2.1% in the > ,"[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Kendrick', 'Affiliation': 'Univeristy of Colorado Anschutz Medical Campus, Aurora, CO, 80045, USA. Jessica.Kendrick@cuanschutz.edu.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': 'Univeristy of Colorado Anschutz Medical Campus, Aurora, CO, 80045, USA.'}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'You', 'Affiliation': 'Univeristy of Colorado Anschutz Medical Campus, Aurora, CO, 80045, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Jovanovich', 'Affiliation': 'Univeristy of Colorado Anschutz Medical Campus, Aurora, CO, 80045, USA.'}]",Journal of nephrology,['10.1007/s40620-020-00747-8'] 567,14647891,Prone ventilation following witnessed pulmonary aspiration: the effect on oxygenation.,"OBJECTIVE Pulmonary aspiration is a significant cause of admission to the ITU and is associated with significant morbidity and mortality. Aspiration in the supine position produces posterior collapse/consolidation, similar to that seen in ALI/ARDS patients. Prone positioning has been shown to improve oxygenation in ALI/ARDS, but no studies have been performed on pulmonary aspiration. DESIGN A prospective crossover study. SETTING Twelve-bed ITU. PATIENTS AND PARTICIPANTS Eleven patients admitted to ITU with respiratory failure secondary to witnessed pulmonary aspiration requiring ventilation and an FIO(2) >0.50 after 12 h. INTERVENTIONS Patients were placed in a prone position for 8 h and then turned supine for 8 h. Prone positioning was repeated if the FIO(2) remained >0.50. Ventilator settings were not altered in the study period. MEASUREMENTS AND RESULTS Arterial blood gas analysis was performed every 2 h. The PaO(2)/FIO(2) gradient was calculated. Oxygenation improved on turning prone, with a significant increase in the PaO(2)/FIO(2) ratio ( P<0.01). There was a fall in this gradient on return to the supine position. There was a significant improvement in oxygenation on turning prone for the second period ( P<0.01). Overall, there was a significant improvement in the PaO(2)/FIO(2) ratio in the final supine position when compared to the first ( P<0.05). CONCLUSION This study demonstrates a significant improvement in oxygenation in the prone position in pulmonary aspiration. Early prone positioning in patients with pulmonary aspiration requiring ventilation may improve oxygenation by altering V/Q relationships similarly to ARDS, but also may aid drainage of secretions, opening up alveoli and preventing progression to established pneumonitis.",2003,"Oxygenation improved on turning prone, with a significant increase in the PaO(2)/FIO(2) ratio ( P<0.01).","['Eleven patients admitted to ITU with respiratory failure secondary to witnessed pulmonary aspiration requiring ventilation and an FIO(2) >0.50 after 12 h', 'pulmonary aspiration', 'Twelve-bed ITU', 'patients with pulmonary aspiration requiring ventilation']",[],"['Oxygenation', 'PaO(2)/FIO(2) ratio', 'oxygenation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit (procedure)'}, {'cui': 'C3889105', 'cui_str': 'Respiratory failure (SMQ)'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0700198', 'cui_str': 'Pulmonary aspiration (finding)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]",[],"[{'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",11.0,0.0244305,"Oxygenation improved on turning prone, with a significant increase in the PaO(2)/FIO(2) ratio ( P<0.01).","[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Easby', 'Affiliation': 'Critical Care Service, The James Cook University Hospital, Middlesbrough, TS4 3BW, UK.'}, {'ForeName': 'Babu K', 'Initials': 'BK', 'LastName': 'Abraham', 'Affiliation': 'Critical Care Service, The James Cook University Hospital, Middlesbrough, TS4 3BW, UK.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Bonner', 'Affiliation': 'Critical Care Service, The James Cook University Hospital, Middlesbrough, TS4 3BW, UK. Steve.Bonner@btinternet.com.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Graham', 'Affiliation': 'Critical Care Service, The James Cook University Hospital, Middlesbrough, TS4 3BW, UK.'}]",Intensive care medicine,['10.1007/s00134-003-1983-9'] 568,32498755,Effects of slow- v. fast-digested protein supplementation combined with mixed power training on muscle function and functional capacities in older men.,"Ageing leads to a progressive loss of muscle function (MF) and quality (MQ: muscle strength (MS)/lean muscle mass (LM)). Power training and protein (PROT) supplementation have been proposed as efficient interventions to improve MF and MQ. Discrepancies between results appear to be mainly related to the type and/or dose of proteins used. The present study aimed at determining whether or not mixed power training (MPT) combined with fast-digested PROT (F-PROT) leads to greater improvements in MF and MQ in elderly men than MPT combined with slow-digested PROT (S-PROT) or MPT alone. Sixty elderly men (age 69 (sd 7) years; BMI 18-30 kg/m2) were randomised into three groups: (1) placebo + MPT (PLA; n 19); (2) F-PROT + MPT (n 21) and (3) S-PROT + MPT (n 20) completed the intervention. LM, handgrip and knee extensor MS and MQ, functional capacity, serum metabolic markers, skeletal muscle characteristics, dietary intake and total energy expenditure were measured. The interventions consisted in 12 weeks of MPT (3 times/week; 1 h/session) combined with a supplement (30 g:10 g per meal) of F-PROT (whey) or S-PROT (casein) or a placebo. No difference was observed among groups for age, BMI, number of steps and dietary intake pre- and post-intervention. All groups improved significantly their LM, lower limb MS/MQ, functional capacity, muscle characteristics and serum parameters following the MPT. Importantly, no difference between groups was observed following the MPT. Altogether, adding 30 g PROT/d to MPT, regardless of the type, does not provide additional benefits to MPT alone in older men ingesting an adequate (i.e. above RDA) amount of protein per d.",2021,"No difference was observed among groups for age, BMI, number of steps and dietary intake pre- and post-intervention.","['Sixty elderly men (Age:69±7years; BMI:18-30kg.m-2', 'elderly men than MPT combined with slow-digested PROT (S-PROT) or MPT alone']","['MPT (3-times/week;1h/session) combined with a supplement (30g: 10g per meal) of F-PROT (whey) or S-PROT (casein) or a Placebo', 'Placebo+MPT (PLA; n=19); 2) F-PROT+MPT', 'S-PROT+MPT', 'not mixed power training (MPT) combined with fast-digested PROT (F-PROT', 'Power training and protein (PROT) supplementation']","['LM, and lower limb MS/MQ, functional capacity, muscle characteristics and serum parameters', 'LM, handgrip and knee extensor MS and MQ, functional capacity, serum metabolic markers, skeletal muscle characteristics, dietary intake and total energy expenditure']","[{'cui': 'C0524337', 'cui_str': 'Elderly man'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0429629', 'cui_str': 'Total energy expenditure'}]",60.0,0.0199228,"No difference was observed among groups for age, BMI, number of steps and dietary intake pre- and post-intervention.","[{'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Dulac', 'Affiliation': 'Département de Biologie, Faculté des sciences, Université du Québec à Montréal, Montréal, QC, Canada, H2X 1Y4.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Pion', 'Affiliation': 'Département de Biologie, Faculté des sciences, Université du Québec à Montréal, Montréal, QC, Canada, H2X 1Y4.'}, {'ForeName': 'F C', 'Initials': 'FC', 'LastName': 'Lemieux', 'Affiliation': ""Département des sciences de l'activité physique, Faculté des sciences, Université du Québec à Montréal, Montréal, QC, Canada, H2X 1Y4.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Pinheiro Carvalho', 'Affiliation': ""Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal, QC, Canada, H3W 1W6.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'El Hajj Boutros', 'Affiliation': ""Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal, QC, Canada, H3W 1W6.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bélanger', 'Affiliation': ""Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal, QC, Canada, H3W 1W6.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Gaudreau', 'Affiliation': 'Department of Medicine, University of Montreal, Montréal, QC, Canada, H3G 2M1.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chevalier', 'Affiliation': 'Department of Medicine, McGill University Health Centre-Research Institute, McGill University, Montréal, QC, Canada, H3H 2L9.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Morais', 'Affiliation': 'Department of Medicine, McGill University Health Centre-Research Institute, McGill University, Montréal, QC, Canada, H3H 2L9.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Noirez', 'Affiliation': ""Département des sciences de l'activité physique, Faculté des sciences, Université du Québec à Montréal, Montréal, QC, Canada, H2X 1Y4.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Gouspillou', 'Affiliation': ""Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal, QC, Canada, H3W 1W6.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Aubertin-Leheudre', 'Affiliation': ""Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal, QC, Canada, H3W 1W6.""}]",The British journal of nutrition,['10.1017/S0007114520001932'] 569,23326865,"Effect of aliskiren on proteinuria in non-diabetic chronic kidney disease: a double-blind, crossover, randomised, controlled trial.","AIM To evaluate the proteinuria-lowering effect of a renin inhibitor (aliskiren), compared to placebo and to an angiotensin-converting enzyme inhibitor (perindopril), in patients with non-diabetic chronic kidney disease. METHODS A randomised, double-blind, crossover trial was performed in 14 patients with nondiabetic chronic kidney disease with 24-h mean proteinuria of 2.01 g (95% CI, 1.36–2.66) and estimated creatinine clearance of 93±6.8 ml/min. The study consisted of five treatment periods. The patients were randomly assigned to receive aliskiren (150 mg), aliskiren (300 mg), perindopril (5 mg), perindopril (10 mg) or placebo. RESULTS Aliskiren and perindopril reduced proteinuria. These effects were dose-dependent. Furthermore, 24-h proteinuria was reduced by 23% (mean 95% CI; 2–44) by treatment with aliskiren (150 mg), by 36% (95% CI, 17–55; P<0.001) with aliskiren (300 mg), by 7.1% (95% CI, 11–26) with perindopril (5 mg) and by 25% (95% CI, 11–39; P<0.05) with perindopril (10 mg), compared to placebo. No significant difference was found between the effects of aliskiren and perindopril. CONCLUSIONS Aliskiren significantly reduced proteinuria. The antiproteinuric effect is probably similar to that of perindopril, for equivalent hypotensive dosages. The renin inhibitor provides a promising alternative approach for the treatment of patients with chronic proteinuric non-diabetic kidney disease.",2012,"Furthermore, 24-h proteinuria was reduced by 23% (mean 95% CI; 2–44) by treatment with aliskiren (150 mg), by 36% (95% CI, 17–55; P<0.001) with aliskiren (300 mg), by 7.1% (95% CI, 11–26) with perindopril (5 mg) and by 25% (95% CI, 11–39; P<0.05) with perindopril (10 mg), compared to placebo.","['14 patients with nondiabetic chronic kidney disease with 24-h mean proteinuria of 2.01 g (95% CI, 1.36–2.66) and estimated creatinine clearance of 93±6.8 ml/min', 'patients with chronic proteinuric non-diabetic kidney disease', 'patients with non-diabetic chronic kidney disease', 'non-diabetic chronic kidney disease']","['renin inhibitor', 'Aliskiren', 'placebo', 'perindopril', 'aliskiren', 'renin inhibitor (aliskiren', 'angiotensin-converting enzyme inhibitor (perindopril']","['proteinuria', '24-h proteinuria', 'antiproteinuric effect']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0011881', 'cui_str': 'Diabetic Nephropathy'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C3653375', 'cui_str': 'Renin-inhibitors'}, {'cui': 'C1120110', 'cui_str': 'aliskiren'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0136123', 'cui_str': 'Perindopril'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}]","[{'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",14.0,0.483734,"Furthermore, 24-h proteinuria was reduced by 23% (mean 95% CI; 2–44) by treatment with aliskiren (150 mg), by 36% (95% CI, 17–55; P<0.001) with aliskiren (300 mg), by 7.1% (95% CI, 11–26) with perindopril (5 mg) and by 25% (95% CI, 11–39; P<0.05) with perindopril (10 mg), compared to placebo.","[{'ForeName': 'Sławomir', 'Initials': 'S', 'LastName': 'Lizakowski', 'Affiliation': 'Department of Nephrology, Transplantology and Internal Medicine, Medical University of Gdańsk, Gdańsk, Poland. slizak@gumed.edu.pl'}, {'ForeName': 'Leszek', 'Initials': 'L', 'LastName': 'Tylicki', 'Affiliation': ''}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Renke', 'Affiliation': ''}, {'ForeName': 'Przemysław', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': ''}, {'ForeName': 'Zbigniew', 'Initials': 'Z', 'LastName': 'Heleniak', 'Affiliation': ''}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Sławińska-Morawska', 'Affiliation': ''}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Aleksandrowicz', 'Affiliation': ''}, {'ForeName': 'Wieslawa', 'Initials': 'W', 'LastName': 'Łysiak-Szydłowska', 'Affiliation': ''}, {'ForeName': 'Bolesław', 'Initials': 'B', 'LastName': 'Rutkowski', 'Affiliation': ''}]",International urology and nephrology,[] 570,32438531,Intermittent Fasting Does Not Uniformly Impact Genes Involved in Circadian Regulation in Women with Obesity.,"OBJECTIVE This study aimed to examine the effects of intermittent fasting (IF) on mRNA levels of peripheral clock genes in skeletal muscle and subcutaneous adipose tissue (SAT) in women with obesity. METHODS Women were randomized to one of two IF protocols and provided with all foods at 100% or 70% of calculated weekly energy requirements for 8 weeks. Breakfast was consumed before a 24-hour fast, which was initiated on three nonconsecutive days per week. Muscle and SAT biopsies were performed at 8 am after an overnight fast at baseline and at week 8 on a refed day and again following a 24-hour fast at week 8 for analysis of the mRNA levels of key genes involved in circadian regulation. RESULTS A group-by-time interaction was observed in Per2 in muscle (F = 3.497, P = 0.044) and SAT (F = 6.686, P = 0.008), but significance was lost upon post hoc adjustment. A time effect was observed in Rorα in muscle, which was decreased by refeeding in both groups (F = 7.225, P = 0.003). CONCLUSIONS There was no universal effect of IF to alter peripheral clocks, which may be partly because of the alignment of the fasting/feeding cycle with the biological clock. Optimizing intermittent fasting protocols could be important to prevent circadian misalignment in humans.",2020,"RESULTS A group-by-time interaction was observed in Per2 in muscle (F = 3.497, P = 0.044) and SAT (F = 6.686, P = 0.008), but significance was lost upon post hoc adjustment.","['women with obesity', 'Women with Obesity', 'Women']",['intermittent fasting (IF'],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C4704881', 'cui_str': 'Intermittent Fasting'}]",[],,0.0900366,"RESULTS A group-by-time interaction was observed in Per2 in muscle (F = 3.497, P = 0.044) and SAT (F = 6.686, P = 0.008), but significance was lost upon post hoc adjustment.","[{'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Adelaide Medical School, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Amy T', 'Initials': 'AT', 'LastName': 'Hutchison', 'Affiliation': 'Adelaide Medical School, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Wittert', 'Affiliation': 'Adelaide Medical School, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Campbell H', 'Initials': 'CH', 'LastName': 'Thompson', 'Affiliation': 'Adelaide Medical School, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Lange', 'Affiliation': 'Adelaide Medical School, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Adelaide Medical School, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Leonie K', 'Initials': 'LK', 'LastName': 'Heilbronn', 'Affiliation': 'Adelaide Medical School, University of Adelaide, Adelaide, South Australia, Australia.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22775'] 571,32140989,The CABI Trial: an Unblinded Parallel Group Randomised Controlled Feasibility Trial of Long-Course Antibiotic Therapy (28 Days) Compared with Short Course (≤ 10 Days) in the Prevention of Relapse in Adults Treated for Complicated Intra-Abdominal Infection.,"PURPOSE Relapse after complicated intra-abdominal infection (cIAI) remains common after treatment. The optimal antibiotic treatment duration for cIAIs is uncertain, especially in cases where source control is not achieved. We hypothesised that in patients with cIAIs, regardless of source control intervention, there would be a lower relapse rate with long-course antibiotics (28 days) compared with short course (≤ 10 days). We piloted a trial comparing ≤ 10-day with 28-day antibiotic treatment for cIAI. METHODS A randomised controlled unblinded feasibility trial was conducted. Eligible participants were adult patients with a cIAI that were diagnosed ≤ 6 days prior to screening. Randomisation was to long-course (28 days) or short-course (≤10 days) antibiotic therapy. Choice of antibiotics was determined by the clinical team. Participants were followed up for 90 days. Primary outcomes were willingness of participants to be randomised and feasibility of trial procedures. RESULTS In total, 172 patients were screened, 84/172 (48.8%) were eligible, and 31/84 (36.9%) were randomised. Patients were assigned to either the short-course arm (18/31, 58.0%) or the long-course arm (13/31, 41.9%). One patient in the short-course arm withdrew after randomisation. In the short-course arm, 4/17 (23.5%) were treated for a cIAI relapse vs 0/13 (0.0%) relapses in the long-course arm. Protocol violations included deviations from protocol-assigned antibiotic duration and interruptions to antibiotic therapy. CONCLUSIONS This feasibility study identified opportunities to increase recruitment in a full trial. This study demonstrates completion of a randomised controlled trial to further evaluate if the optimum antibiotic duration for cIAIs is feasible. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03265834.",2021,"Patients were assigned to either the short-course arm (18/31, 58.0%) or the long-course arm (13/31, 41.9%).","['172 patients were screened, 84/172 (48.8%) were eligible, and 31/84 (36.9%) were randomised', 'Eligible participants were adult patients with a cIAI that were diagnosed ≤\u20096\xa0days prior to screening']",['Long-Course Antibiotic Therapy (28\xa0Days'],"['relapse rate', 'cIAI relapse']","[{'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}]",172.0,0.359235,"Patients were assigned to either the short-course arm (18/31, 58.0%) or the long-course arm (13/31, 41.9%).","[{'ForeName': 'Shadia', 'Initials': 'S', 'LastName': 'Ahmed', 'Affiliation': 'Microbiology Department, Old Medical School, Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust, Leeds, LS1 3EX, UK. shadiaahmed@nhs.net.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Brown', 'Affiliation': 'Microbiology Department, Old Medical School, Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust, Leeds, LS1 3EX, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pettinger', 'Affiliation': 'Microbiology Department, Old Medical School, Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust, Leeds, LS1 3EX, UK.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Vargas-Palacios', 'Affiliation': 'University of Leeds, Leeds, LS3 1EX, UK.'}, {'ForeName': 'Dermot', 'Initials': 'D', 'LastName': 'Burke', 'Affiliation': 'Microbiology Department, Old Medical School, Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust, Leeds, LS1 3EX, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Kirby', 'Affiliation': 'Microbiology Department, Old Medical School, Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust, Leeds, LS1 3EX, UK.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-020-04545-2'] 572,32504715,Rehabilitation Posture Does Not Affect the Outcome of Arthroscopically Treated Acromioclavicular Dislocation.,"PURPOSE To assess the effect of the patient's posture (erect or supine) during rehabilitation sessions on pain, function, and the coracoclavicular (CC) distance after arthroscopic treatment of acromioclavicular joint dislocation. METHODS Sixty patients with acute type III or V acromioclavicular dislocation injuries were randomly allocated into 2 groups according to their posture during the rehabilitation phase: supine rehabilitation group (SRG) or erect rehabilitation group (ERG). Arthroscopic stabilization with a suspensory fixation device was used in all patients. The visual analog scale (VAS) score was assessed on the first postoperative day and at 1, 3, and 6 months postoperatively. The Constant-Murley score (CMS) was recorded preoperatively and at 3, 6, 12, and 24 months postoperatively. The CC distance was assessed preoperatively; on the first postoperative day; and at 6, 12, and 24 months postoperatively. RESULTS No significant differences were found between the 2 groups in terms of the VAS score, CMS, and CC distance changes. A significant improvement over the follow-up phase was identified in the VAS score and CMS in both groups. The CC distance in both groups was significantly reduced from preoperatively (29.34 mm in the ERG and 28.65 mm in the SRG) to the first postoperative day (10.44 mm and 10.11 mm, respectively). However, a statistically significant re-widening of the CC distance (P < .001) occurred within the first 6 months after surgery (13.55 mm in the ERG and 13.50 mm in the SRG) and at 12 months (15.51 mm and 15.80 mm, respectively). CONCLUSIONS The patient's posture during early postoperative rehabilitation does not affect the CC distance changes. LEVEL OF EVIDENCE Level I, randomized prospective comparative study.",2020,"No significant differences were found between the two groups in terms of the VAS, CMS scores, and CC distance changes.","['Sixty patients with acute AC dislocation injury types, III and V']","['Arthroscopic stabilization with a suspensory fixation device', ""patient's posture (erect or supine"", 'posture during the rehabilitation phase (Supine Rehabilitation Group; SRG, or Erect Rehabilitation Group; ERG']","['coracoclavicular (CC) distance', 'Constant-Murley Score (CMS', 'CC distance', 'Visual Analogue Scale (VAS', 'coracoclavicular distance changes', 'VAS, CMS scores, and CC distance changes', 'pain, function and the CC (Coracoclavicular) distance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0012691', 'cui_str': 'Dislocation'}, {'cui': 'C0449499', 'cui_str': 'Type of injury'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0441254', 'cui_str': 'Fixation device'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013867', 'cui_str': 'Electroretinography'}]","[{'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",60.0,0.018762,"No significant differences were found between the two groups in terms of the VAS, CMS scores, and CC distance changes.","[{'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Ibrahim', 'Affiliation': 'Orthopedic Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Saleh', 'Initials': 'S', 'LastName': 'Gameel', 'Affiliation': 'Orthopedic Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Abdelghafar', 'Affiliation': 'Orthopedic Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Tarek Mohamed', 'Initials': 'TM', 'LastName': 'Ghandour', 'Affiliation': 'Orthopedic Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt. Electronic address: tarekghndr@yahoo.com.'}, {'ForeName': 'Begad M', 'Initials': 'BM', 'LastName': 'Samy Abbas', 'Affiliation': 'Physical Medicine, Rheumatology and Rehabilitation Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2020.05.043'] 573,31858835,Training Inhibitory Control Induced Robust Neural Changes When Behavior Is Affected: A Follow-up Study Using Cognitive Event-Related Potentials.,"Cognitive training results in significant, albeit modest, improvements in specific cognitive functions across a range of mental illnesses. Inhibitory control, defined as the ability to stop the execution of an automatic reaction or a planned motor behavior, is known to be particularly important for the regulation of health behaviors, including addictive behaviors. For example, several studies have indicated that inhibitory training can lead to reduced alcohol consumption or a loss of weight/reduced energy intake. However, the exact neurocognitive mechanisms that underlie such behavioral changes induced by training are still matter of debate. In the present study, we investigated the long-term impact (ie, at 1 week posttraining) of an inhibitory training program (composed of 4 consecutive daily training sessions of 20 minutes each) on the performance of a Go/No-go task. Healthy participants were randomly assigned to 1 of 3 designated groups: (1) an Inhibition Training (IT) group that received training based on a hybrid flanker Go/No-go task; (2) a group that received a noninhibition-based (ie, episodic memory; EM) training; and (3) a No-Training (NT) group to control for test-retest effects. Each group underwent 3 sessions of a Go/No-go task concomitant with the recording of event-related potentials. Our results revealed a specific impact of the Inhibitory Training on the Go/No-go task, indexed by a faster process compared with the other 2 groups. This effect was neurophysiologically indexed by a faster N2 component on the difference NoGo-Go waveform. Importantly, effects at both the behavioral and at the neural level were still readily discernible 1 week posttraining. Thus, our data clearly corroborate the notion that cognitive training is effective, while also indicating that it may persist over time.",2020,"Our results revealed a specific impact of the Inhibitory Training on the Go/No-go task, indexed by a faster process compared with the other 2 groups.",['Healthy participants'],"['Inhibition Training (IT) group that received training based on a hybrid flanker', 'noninhibition-based (ie, episodic memory; EM) training; and (3) a No-Training (NT', 'Go/No-go task concomitant with the recording of event-related potentials', 'inhibitory training program', 'Cognitive training']","['Neural Changes', 'specific cognitive functions']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0282171', 'cui_str': 'Potentials, Event-Related'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}]",,0.0162187,"Our results revealed a specific impact of the Inhibitory Training on the Go/No-go task, indexed by a faster process compared with the other 2 groups.","[{'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Schroder', 'Affiliation': ""Laboratoire de Psychologie Médicale et d'Addictologie, ULB Neuroscience Institute (UNI), CHU Brugmann-Université Libre de Bruxelles (U.L.B.), Brussels, Belgium.""}, {'ForeName': 'Macha', 'Initials': 'M', 'LastName': 'Dubuson', 'Affiliation': ""Laboratoire de Psychologie Médicale et d'Addictologie, ULB Neuroscience Institute (UNI), CHU Brugmann-Université Libre de Bruxelles (U.L.B.), Brussels, Belgium.""}, {'ForeName': 'Clémence', 'Initials': 'C', 'LastName': 'Dousset', 'Affiliation': ""Laboratoire de Psychologie Médicale et d'Addictologie, ULB Neuroscience Institute (UNI), CHU Brugmann-Université Libre de Bruxelles (U.L.B.), Brussels, Belgium.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Mortier', 'Affiliation': ""Laboratoire de Psychologie Médicale et d'Addictologie, ULB Neuroscience Institute (UNI), CHU Brugmann-Université Libre de Bruxelles (U.L.B.), Brussels, Belgium.""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Kornreich', 'Affiliation': ""Laboratoire de Psychologie Médicale et d'Addictologie, ULB Neuroscience Institute (UNI), CHU Brugmann-Université Libre de Bruxelles (U.L.B.), Brussels, Belgium.""}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Campanella', 'Affiliation': ""Laboratoire de Psychologie Médicale et d'Addictologie, ULB Neuroscience Institute (UNI), CHU Brugmann-Université Libre de Bruxelles (U.L.B.), Brussels, Belgium.""}]",Clinical EEG and neuroscience,['10.1177/1550059419895146'] 574,30777901,Comparison of dexmedetomidine and benzodiazepine for intraoperative sedation in elderly patients: a randomized clinical trial.,"BACKGROUND AND OBJECTIVES Elderly individuals have a greater sensitivity to sedation, and the most commonly used drugs for sedation are benzodiazepines, which exhibit some complication. Therefore, this study aimed to compare the use of dexmedetomidine and midazolam regarding proper sedation and postoperative complications in elderly individuals who require intraoperative sedation. METHODS This study was a parallel-randomized clinical trial, which included 120 patients aged >70 years undergoing regional anesthesia and sedation. The exclusion criteria consisted of bradycardia, heart failure, respiratory failure, a Glasgow Coma Scale ≤14, liver failure and refusal to participate. Patients were divided into two groups: the first group received midazolam (MDZ), while the second group received dexmedetomidine (DEX). The doses were titrated to achieve an intraoperative Richmond Agitation-Sedation Scale (RASS) score between -3 and -1. Incidences of complications were recorded. RESULTS During a 120 min follow-up, the depth of sedation (RASS score) revealed variations less often in the DEX group (p=0.002). Patients in the DEX group (n=67) had lower rates of intraoperative complications (19.4% vs 73.6%, p<0.001). Intraoperatively, the incidence rates of psychomotor agitation (15.1% vs 1.5%, p=0.005), arterial hypotension (28.3% vs 3.0%, p<0.001) and respiratory depression (73.6% vs 0%, p<0.001) were higher in the MDZ group (n=53). During postanesthesia care, the incidence rates of shivering (p<0.001), residual sedation (p=0.04) and use of supplemental oxygen (p<0.001) were significantly lower in the DEX group. CONCLUSIONS The use of DEX for sedation during surgery provides better control over the depth of sedation and produces fewer complications in elderly individuals. TRIAL REGISTRATION NUMBER NCT02878837.",2019,"During postanesthesia care, the incidence rates of shivering (p<0.001), residual sedation (p=0.04) and use of supplemental oxygen (p<0.001) were significantly lower in the DEX group. ","['120 patients aged >70\u2009years undergoing regional anesthesia and sedation', 'elderly individuals who require intraoperative sedation', 'Elderly individuals', 'elderly individuals', 'elderly patients']","['dexmedetomidine (DEX', 'DEX', 'MDZ', 'dexmedetomidine and benzodiazepine', 'midazolam (MDZ', 'dexmedetomidine and midazolam']","['intraoperative Richmond Agitation-Sedation Scale (RASS) score', 'depth of sedation (RASS score', 'rates of intraoperative complications', 'arterial hypotension', 'respiratory depression', 'incidence rates of psychomotor agitation', 'bradycardia, heart failure, respiratory failure, a Glasgow Coma Scale ≤14, liver failure and refusal to participate', 'Incidences of complications', 'incidence rates of shivering (p<0.001), residual sedation (p=0.04) and use of supplemental oxygen']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0002911', 'cui_str': 'Anesthesia, Regional'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0021890', 'cui_str': 'Peroperative Complications'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0235063', 'cui_str': 'Respiratory Depression'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3887612', 'cui_str': 'Restlessness'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C3889105', 'cui_str': 'Respiratory failure (SMQ)'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale (assessment scale)'}, {'cui': 'C0085605', 'cui_str': 'Hepatic Failure'}, {'cui': 'C1136454', 'cui_str': 'Refusal to Participate'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0036973', 'cui_str': 'Shiverings'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]",120.0,0.200622,"During postanesthesia care, the incidence rates of shivering (p<0.001), residual sedation (p=0.04) and use of supplemental oxygen (p<0.001) were significantly lower in the DEX group. ","[{'ForeName': 'João Manoel', 'Initials': 'JM', 'LastName': 'Silva-Jr', 'Affiliation': 'Department of Anesthesiology, Hospital Servidor Público Estadual-Instituto de Assistência Médica ao Servidor Público Estadual, São Paulo, Brazil joao.s@globo.com.'}, {'ForeName': 'Henrique T', 'Initials': 'HT', 'LastName': 'Katayama', 'Affiliation': 'Department of Anesthesiology, Hospital Servidor Público Estadual-Instituto de Assistência Médica ao Servidor Público Estadual, São Paulo, Brazil.'}, {'ForeName': 'Fernando A M', 'Initials': 'FAM', 'LastName': 'Nogueira', 'Affiliation': 'Department of Anesthesiology, Hospital Servidor Público Estadual-Instituto de Assistência Médica ao Servidor Público Estadual, São Paulo, Brazil.'}, {'ForeName': 'Tatiane B', 'Initials': 'TB', 'LastName': 'Moura', 'Affiliation': 'Department of Anesthesiology, Hospital Servidor Público Estadual-Instituto de Assistência Médica ao Servidor Público Estadual, São Paulo, Brazil.'}, {'ForeName': 'Thiago L', 'Initials': 'TL', 'LastName': 'Alves', 'Affiliation': 'Department of Anesthesiology, Hospital Servidor Público Estadual-Instituto de Assistência Médica ao Servidor Público Estadual, São Paulo, Brazil.'}, {'ForeName': 'Barbara W', 'Initials': 'BW', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Anesthesiology, Hospital Servidor Público Estadual-Instituto de Assistência Médica ao Servidor Público Estadual, São Paulo, Brazil.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2018-100120'] 575,31907828,Evidence for Relationship Between Early Dumping and Postprandial Hypoglycemia After Roux-en-Y Gastric Bypass.,"BACKGROUND Early dumping and post-bariatric hypoglycemia (PBH) are often addressed as two separate postprandial complications after Roux-en-Y gastric bypass (RYGB). The aim of the study was to evaluate the occurrence of early dumping in RYGB-operated individuals with PBH with and without treatment intervention. METHODS Eleven RYGB-operated women with documented PBH each underwent a baseline liquid mixed meal test (MMT) followed by five MMTs preceded by treatment with: acarbose 50 mg for 1 week, sitagliptin 100 mg for 1 week, verapamil 120 mg for 1 week, liraglutide 1.2 mg for 3 weeks, and pasireotide 300 μg as a single dose. Repetitive venous blood sampling and continuous electrocardiogram recordings were performed at fasting and during a 3-h postprandial period. RESULTS During the baseline MMT, there was a significant increase in HR (from 65 ± 2 to 90 ± 4 bpm, p < 0.0001) within 30 min after meal intake, while hypoglycemia occurred in the later postprandial period. The HR increase was accompanied by significant increases in serum albumin, plasma norepinephrine, blood glucose, serum insulin, and plasma GLP-1 concentrations. The postprandial HR changes were positively correlated with the changes in insulin and GLP-1 concentrations. Treatment with acarbose and pasireotide both reduced HR, plasma norepinephrine, and serum insulin, and pasireotide also decreased plasma GLP-1. CONCLUSIONS RYGB-operated individuals with PBH also have large early postprandial HR increases, hemoconcentration, and sympathetic activation, consistent with early dumping. Moreover, hormone excursions associated with PBH appear to be related to measures of early dumping, suggesting a causal relationship between early dumping and PBH. TRIAL REGISTRATION NCT02527993.",2020,"Treatment with acarbose and pasireotide both reduced HR, plasma norepinephrine, and serum insulin, and pasireotide also decreased plasma GLP-1. ","['RYGB-operated individuals with PBH with and without treatment intervention', 'Eleven RYGB-operated women with documented PBH each underwent a']","['acarbose 50\xa0mg for 1\xa0week, sitagliptin 100\xa0mg for 1\xa0week, verapamil', 'liraglutide', 'acarbose and pasireotide', 'baseline liquid mixed meal test (MMT']","['postprandial HR changes', 'Repetitive venous blood sampling and continuous electrocardiogram recordings', 'hemoconcentration, and sympathetic activation', 'insulin and GLP-1 concentrations', 'Postprandial Hypoglycemia', 'hypoglycemia', 'HR', 'HR, plasma norepinephrine, and serum insulin, and pasireotide also decreased plasma GLP-1', 'serum albumin, plasma norepinephrine, blood glucose, serum insulin, and plasma GLP-1 concentrations']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1301725', 'cui_str': 'Documented'}]","[{'cui': 'C0982924', 'cui_str': 'Acarbose 50 MG'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1812980', 'cui_str': 'sitagliptin 100 MG'}, {'cui': 'C0042523', 'cui_str': 'Verapamil'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0050393', 'cui_str': 'Acarbose'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0046370', 'cui_str': 'MMT'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0190979', 'cui_str': 'Venesection'}, {'cui': 'C0199562', 'cui_str': 'Continuous electrocardiogram (procedure)'}, {'cui': 'C0854379', 'cui_str': 'Haemoconcentration'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0271710', 'cui_str': 'Postprandial Hypoglycemia'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum (procedure)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}]",11.0,0.0160128,"Treatment with acarbose and pasireotide both reduced HR, plasma norepinephrine, and serum insulin, and pasireotide also decreased plasma GLP-1. ","[{'ForeName': 'Caroline C', 'Initials': 'CC', 'LastName': 'Øhrstrøm', 'Affiliation': 'Department of Medicine, Zealand University Hospital, Lykkebækvej 1, 4600, Køge, Denmark. carolinechristfort@hotmail.com.'}, {'ForeName': 'Dorte', 'Initials': 'D', 'LastName': 'Worm', 'Affiliation': 'Department of Medicine, Amager Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Urd Lynge', 'Initials': 'UL', 'LastName': 'Kielgast', 'Affiliation': 'Department of Medicine, Zealand University Hospital, Lykkebækvej 1, 4600, Køge, Denmark.'}, {'ForeName': 'Jens Juul', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences and Novo Nordisk Foundation Center for Basic Metabolic Research, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Dorte L', 'Initials': 'DL', 'LastName': 'Hansen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}]",Obesity surgery,['10.1007/s11695-020-04387-6'] 576,31439531,Comparison of topical treatment methods used in recurrent anterior epistaxis: a randomized clinical trial.,"INTRODUCTION Recurrent epistaxis is a common medical problem faced by ENT specialists, emergency physicians, and pediatricians. The facts that many treatment modalities are being searched and no single treatment method is universally accepted yet support this information. OBJECTIVE We aimed to compare the clinical efficacy of topical antiseptic ointment, topical decongestant ointment and chemical cauterization treatments, which are frequently used in recurrent anterior epistaxis, both singly and in combination. MATERIAL-METHODS Between August 2017 and February 2018, 137 patients who were diagnosed with recurrent anterior epistaxis were randomly divided into 5 groups. group I received topical antiseptic ointment, group II received topical decongestant ointment, group III received chemical cauterization, group IV received topical antiseptic ointment + chemical cauterization and group V received topical decongestant ointment + chemical cauterization treatment. All patients were phoned 2 weeks and 1 month after the treatment and questioned about the presence (failure) or absence (success) of at least 1 episode of epistaxis. Patients with comorbid diseases were excluded. Treatment success was statistically analysed. RESULTS There was no significant difference (p > 0.05) between the groups in the success rate at 15th day after treatment. Group IV and group V had higher success rates at 30th day after treatment compared with group I and group II (p < 0.05). In group III 30th day treatment success was not different from the other 4 groups (p > 0.05). CONCLUSION Although the number of patients who improved with chemical cauterization (group III) was higher in our study, no significant difference was observed in single treatment modalities (group I‒III) at 14th day and 30th day after treatment. Although no statistically significant difference was observed between combined treatments (group IVV) and single treatments (group I‒III) in the 2nd week after treatment, combined treatments were significantly more effective in the 1st month.",2021,"In group III 30th day treatment success was not different from the other 4 groups (p > 0.05). ","['Between August 2017 and February 2018, 137 patients who were diagnosed with recurrent anterior epistaxis', 'Patients with comorbid diseases', 'recurrent anterior epistaxis']","['chemical cauterization', 'topical antiseptic ointment\u202f+\u202fchemical cauterization and group V received topical decongestant ointment\u202f+\u202fchemical cauterization treatment', 'topical decongestant ointment', 'topical antiseptic ointment, topical decongestant ointment and chemical cauterization treatments', 'topical antiseptic ointment']","['success rates', 'success rate']","[{'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0339815', 'cui_str': 'Anterior epistaxis (disorder)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0220806', 'cui_str': 'Chemical (substance)'}, {'cui': 'C0007471', 'cui_str': 'Cauterization'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C3540796', 'cui_str': 'Antiseptic throat preparations'}, {'cui': 'C0028912', 'cui_str': 'Salves'}, {'cui': 'C0441855', 'cui_str': 'Group V (qualifier value)'}, {'cui': 'C0282374', 'cui_str': 'Decongestants'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],137.0,0.024268,"In group III 30th day treatment success was not different from the other 4 groups (p > 0.05). ","[{'ForeName': 'Hasan Emre', 'Initials': 'HE', 'LastName': 'Koçak', 'Affiliation': 'Bakırköy Dr. Sadi Konuk Training and Research Hospital, Department of Otorhinolaryngology, Head and Neck Surgery, Istanbul, Turkey. Electronic address: drhekbb@gmail.com.'}, {'ForeName': 'Zeki Tolga', 'Initials': 'ZT', 'LastName': 'Bilece', 'Affiliation': 'Bakırköy Dr. Sadi Konuk Training and Research Hospital, Department of Otorhinolaryngology, Head and Neck Surgery, Istanbul, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Keskin', 'Affiliation': 'Bakırköy Dr. Sadi Konuk Training and Research Hospital, Department of Otorhinolaryngology, Head and Neck Surgery, Istanbul, Turkey.'}, {'ForeName': 'Hüseyin Avni', 'Initials': 'HA', 'LastName': 'Ulusoy', 'Affiliation': 'Bakırköy Dr. Sadi Konuk Training and Research Hospital, Department of Otorhinolaryngology, Head and Neck Surgery, Istanbul, Turkey.'}, {'ForeName': 'Arzu Karaman', 'Initials': 'AK', 'LastName': 'Koç', 'Affiliation': 'Bakırköy Dr. Sadi Konuk Training and Research Hospital, Department of Otorhinolaryngology, Head and Neck Surgery, Istanbul, Turkey.'}, {'ForeName': 'Kamil Hakan', 'Initials': 'KH', 'LastName': 'Kaya', 'Affiliation': 'Bakırköy Dr. Sadi Konuk Training and Research Hospital, Department of Otorhinolaryngology, Head and Neck Surgery, Istanbul, Turkey.'}]",Brazilian journal of otorhinolaryngology,['10.1016/j.bjorl.2019.07.002'] 577,32495667,"Efficacy of functional magnetic stimulation in improving upper extremity function after stroke: a randomized, single-blind, controlled study.","OBJECTIVE To clarify the efficacy of functional magnetic stimulation (FMS) in improving hemiplegic upper extremity function in patients with sub-acute stroke. METHODS In this randomized controlled trial, 40 sub-acute stroke patients with hemiplegia were recruited from inpatient wards in the Department of Rehabilitation and randomly assigned to two groups. In the FMS group, magnetic stimulation was applied to extensor muscle groups of the affected upper extremity. In the low-frequency repetitive transcranial magnetic stimulation (LF-rTMS) group, stimulation was applied to the contralesional primary motor cortex. All patients received occupational therapy. Hand and upper extremity motor function was evaluated using the Fugl-Meyer Assessment for upper extremity (FMA-UE), and the Barthel Index (BI) evaluated daily living abilities. RESULTS The FMA-UE and BI scores were significantly increased in both groups following stimulation. Furthermore, a significant between-group difference was observed in both FMA-UE and BI scores after 2 weeks of therapy. In the FMS group, 6 of 19 patients regained wrist and finger extension abilities, but only 2 patients regained equivalent motor skills in the LF-rTMS group. CONCLUSIONS FMS improves paretic upper extremity function and leads to better recovery of motor activity than LF-rTMS. FMS may be a novel modality to improve motor function.",2020,"Hand and upper extremity motor function was evaluated using the Fugl-Meyer Assessment for upper extremity (FMA-UE), and the Barthel Index (BI) evaluated daily living abilities. ","['40 sub-acute stroke patients with hemiplegia were recruited from inpatient wards in the Department of Rehabilitation and randomly assigned to two groups', 'patients with sub-acute stroke', 'upper extremity function after stroke']","['occupational therapy', 'low-frequency repetitive transcranial magnetic stimulation (LF-rTMS', 'functional magnetic stimulation', 'functional magnetic stimulation (FMS']","['wrist and finger extension abilities', 'FMA-UE and BI scores', 'paretic upper extremity function', 'equivalent motor skills', 'Barthel Index (BI) evaluated daily living abilities']","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",40.0,0.025792,"Hand and upper extremity motor function was evaluated using the Fugl-Meyer Assessment for upper extremity (FMA-UE), and the Barthel Index (BI) evaluated daily living abilities. ","[{'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, The First Hospital of Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Xuncan', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, The First Hospital of Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Yinxing', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, The First Hospital of Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Guoxing', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, The First Hospital of Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, The First Hospital of Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Xueru', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Jiang', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Zhenlan', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, The First Hospital of Jilin University, Changchun, Jilin, China.'}]",The Journal of international medical research,['10.1177/0300060520927881'] 578,32249509,Center-Based Group and Home-Based Individual Exercise Programs Have Similar Impacts on Gait and Balance in People With Multiple Sclerosis: A Randomized Trial.,"BACKGROUND Group and home-based exercises to improve function in people with multiple sclerosis (MS) are common but have little underpinning evidence. OBJECTIVE To determine the comparative effectiveness of a center-based group versus home-based individual 8-week exercise program to improve gait and balance in people with MS. DESIGN Prospective, randomized controlled trial. SETTING Community center-based and home-based exercise program. PARTICIPANTS Fifty people with MS were randomized and completed allocated intervention (n = 26 center, n = 24 home), 47 completed post-assessment and 44 follow-up assessment. METHODS The center- and home-based groups completed an 8-week progressive functional and balance training exercise program. The center-based groups of four to six were supervised by a physiotherapist. The home-based group was provided with telephone support. MAIN OUTCOME MEASUREMENTS The primary outcome was gait speed (10-meter walk test). Secondary outcomes were gait endurance (6-minute walk test) and balance (Berg Balance Scale). Outcome assessments were conducted at baseline, immediately postintervention and at 8-week follow-up. RESULTS There was no statistically significant difference between groups in gait speed post training, with a mean difference of 0.01 m/s, 95% CI -0.36 to 0.37. There were no group effects, time effects, or interactions for gait speed, endurance, or balance. In both groups, gait speed improved to a level that met minimal clinically important differences. CONCLUSIONS Gait speed, endurance, and balance did not statistically improve in either group; however, gait speed changes met minimally important differences.",2021,,['people with Multiple Sclerosis'],['Center-based group and home-based individual exercise programs'],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0203986', 'cui_str': 'Individual exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.0842804,,"[{'ForeName': 'Katrina Louise', 'Initials': 'KL', 'LastName': 'Williams', 'Affiliation': 'Division of Physiotherapy, School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Nancy Louise', 'Initials': 'NL', 'LastName': 'Low Choy', 'Affiliation': 'School of Physiotherapy, Australian Catholic University (McAuley Campus), Brisbane, Australia.'}, {'ForeName': 'Sandra Gail', 'Initials': 'SG', 'LastName': 'Brauer', 'Affiliation': 'Division of Physiotherapy, School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia.'}]","PM & R : the journal of injury, function, and rehabilitation",['10.1002/pmrj.12377'] 579,32224318,Perspectives on the model-based approach to proton therapy trials: A retrospective study of a lung cancer randomized trial.,"PURPOSE The goal of this study was to assess whether a model-based approach applied retrospectively to a completed randomized controlled trial (RCT) would have significantly altered the selection of patients of the original trial, using the same selection criteria and endpoint for testing the potential clinical benefit of protons compared to photons. METHODS AND MATERIALS A model-based approach, based on three widely used normal tissue complication probability (NTCP) models for radiation pneumonitis (RP), was applied retrospectively to a completed non-small cell lung cancer RCT (NCT00915005). It was assumed that patients were selected by the model-based approach if their expected ΔNTCP value was above a threshold of 5%. The endpoint chosen matched that of the original trial, the first occurrence of severe (grade ≥3) RP. RESULTS Our analysis demonstrates that NTCP differences between proton and photon therapy treatments may be too small to support a model-based trial approach for lung cancer using RP as the normal tissue endpoint. The analyzed lung trial showed that less than 19% (32/165) of patients enrolled in the completed trial would have been enrolled in a model-based trial, prescribing photon therapy to all other patients. The number of patients enrolled was also found to be dependent on the type of NTCP model used for evaluating RP, with the three models enrolling 3%, 13% or 19% of patients. This result does show limitations in NTCP models which would affect the success of a model-based trial approach. No conclusion regarding the development of RP in patients randomized by the model-based approach could statistically be made. CONCLUSIONS Uncertainties in the outcome models to predict NTCP are the inherent drawback of a model-based approach to clinical trials. The impact of these uncertainties on enrollment in model-based trials depends on the predicted difference between the two treatment arms and on the set threshold for patient stratification. Our analysis demonstrates that NTCP differences between proton and photon therapy treatments may be too small to support a model-based trial approach for specific treatment sites, such as lung cancer, depending on the chosen normal tissue endpoint.",2020,"No conclusion regarding the development of RP in patients randomized by the model-based approach could statistically be made. ",[],[],[],[],[],[],,0.0324994,"No conclusion regarding the development of RP in patients randomized by the model-based approach could statistically be made. ","[{'ForeName': 'Aimee L', 'Initials': 'AL', 'LastName': 'McNamara', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital & Harvard Medical School, Boston, USA. Electronic address: amcnamara2@mgh.harvard.edu.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Hall', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital & Harvard Medical School, Boston, USA.'}, {'ForeName': 'Nadya', 'Initials': 'N', 'LastName': 'Shusharina', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital & Harvard Medical School, Boston, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ajdari', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital & Harvard Medical School, Boston, USA.'}, {'ForeName': 'Radhe', 'Initials': 'R', 'LastName': 'Mohan', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'Zhongxing', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Paganetti', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital & Harvard Medical School, Boston, USA.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.02.022'] 580,21373300,Pain treatment in post-traumatic hip fracture in the elderly: regional block vs. systemic non-steroidal analgesics.,"BACKGROUND This prospective, randomized double-blind study, conducted over 19 months in a tertiary care ED, sought to determine if a fascia-iliaca regional anesthetic block provides better and safer pain relief than does parenteral analgesia. AIMS This study also aimed to determine the effectiveness of parenteral NSAID analgesia for acute hip fractures. METHODS Patients >65 years old presenting at an adult ED with acute hip fractures were randomized upon presentation to the ED into two groups (A and B) using numbers generated by the EPI-INFO™ (Atlanta, GA: Centers for Disease Control and Prevention) program. The randomization list was kept by one of the authors who did not interact with the patients. Two groups of patients were to receive either (A) a fascia-iliaca block with bupivacaine and parenteral saline injection, or (B) the same block with saline and an IV NSAID injection. Upon admission to the study, vital signs such as blood pressure, mean blood pressure (MAP), heart rate (HR), respiratory rate (RR) and pain-intensity measurements [using the Visual Analogue Scale (VAS)] were obtained and repeated at 15 min, 2 h and at8 h. The occurrence of complications was registered. RESULTS One hundred seventy-five patients were randomized, and 21 were excluded from participation. The remaining 154 patients were grouped as: group A (n = 62) or group B (n = 92). The mean pain level on admission to the ED for all patients, assessed with the VAS, was 8.21 ± 0.91 (CI 95%: 6.43-9.99); in group A the VAS was 7.6 ± 0.22 and in group B 8.5 ± 0.72 (p = 0.411). At 15-min evaluation, values were: group A 6.24 ± 0.17 and group B 2.9 ± 0.16 (p < 0.001). At the 2-h assessment, values were: group A 1.78 ± 0.11 and group B 2.3 ± 1.16 (p = 0.764). At 8 h the VAS for group A was 2.03 ± 0.12 and for group B 4.4 ± 0.91 (p = 0.083). CONCLUSION THIS STUDY DEMONSTRATES THAT: (1) parenteral NSAIDs are very effective as analgesics after hip fractures in elderly patients, (2) fascia-iliaca regional blocks are nearly as effective for up to about 8 h after administration and (3) regional fascia-iliaca blocks effectively control post-hip fracture pain. (4) Fascia iliaca regional block has a rapid onset.",2010,"At 8 h the VAS for group A was 2.03 ± 0.12 and for group B 4.4 ± 0.91 (p = 0.083). ","['One hundred seventy-five patients were randomized, and 21 were excluded from participation', 'conducted over 19\xa0months in a tertiary care ED', 'acute hip fractures', 'post-traumatic hip fracture in the elderly', 'Patients >65 years old presenting at an adult ED with acute hip fractures']","['EPI-INFO™', 'fascia-iliaca block with bupivacaine and parenteral saline injection, or (B) the same block with saline and an IV NSAID injection', 'parenteral NSAID analgesia', 'Pain treatment']","['mean pain level', 'blood pressure, mean blood pressure (MAP), heart rate (HR), respiratory rate (RR) and pain-intensity measurements [using the Visual Analogue Scale (VAS']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0267963', 'cui_str': 'Pancreatic Insufficiency'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C4522267', 'cui_str': 'Parenteral (intended site)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",175.0,0.0507343,"At 8 h the VAS for group A was 2.03 ± 0.12 and for group B 4.4 ± 0.91 (p = 0.083). ","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Godoy Monzón', 'Affiliation': ''}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Vazquez', 'Affiliation': ''}, {'ForeName': 'José R', 'Initials': 'JR', 'LastName': 'Jauregui', 'Affiliation': ''}, {'ForeName': 'Kenneth V', 'Initials': 'KV', 'LastName': 'Iserson', 'Affiliation': ''}]",International journal of emergency medicine,['10.1007/s12245-010-0234-4'] 581,32493662,Continuous Magnesium Infusion to Prevent Atrial Fibrillation After Cardiac Surgery: A Sequential Matched Case-Controlled Pilot Study.,"OBJECTIVE The authors aimed to test whether a bolus of magnesium followed by continuous intravenous infusion might prevent the development of atrial fibrillation (AF) after cardiac surgery. DESIGN Sequential, matched, case-controlled pilot study. SETTING Tertiary university hospital. PARTICIPANTS Matched cohort of 99 patients before and intervention cohort of 99 consecutive patients after the introduction of a continuous magnesium infusion protocol. INTERVENTIONS The magnesium infusion protocol consisted of a 10 mmol loading dose of magnesium sulphate followed by a continuous infusion of 3 mmol/h over a maximum duration of 96 hours or until intensive care unit discharge. MEASUREMENTS AND MAIN RESULTS The study groups were balanced except for a lower cardiac index in the intervention cohort. The mean duration of magnesium infusion was 27.93 hours (95% confidence interval [CI]: 24.10-31.76 hours). The intervention group had greater serum peak magnesium levels: 1.72 mmol/L ± 0.34 on day 1, 1.32 ± 0.36 on day 2 versus 1.01 ± 1.14 and 0.97 ± 0.13, respectively, in the control group (p < 0.01). Atrial fibrillation occurred in 25 patients (25.3%) in the intervention group and 40 patients (40.4%) in the control group (odds ratio 0.49, 95% CI, 0.27-0.92; p = 0.023). On a multivariate Cox proportional hazards model, the hazard ratio for the development of AF was significantly less in the intervention group (hazard ratio 0.45, 95% CI, 0.26-0.77; p = 0.004). CONCLUSION The magnesium delivery strategy was associated with a decreased incidence of postoperative AF in cardiac surgery patients. These findings provide a rationale and preliminary data for the design of future randomized controlled trials.",2020,"The intervention group had greater serum peak magnesium levels: 1.72 mmol/L ± 0.34 on day 1, 1.32 ± 0.36 on day 2 versus 1.01 ± 1.14 and 0.97 ± 0.13, respectively, in the control group (p < 0.01).","['cardiac surgery patients', 'Tertiary university hospital', 'Matched cohort of 99 patients before and intervention cohort of 99 consecutive patients after the introduction of a continuous magnesium infusion protocol']","['magnesium sulphate', 'Continuous Magnesium Infusion', 'magnesium']","['Atrial Fibrillation', 'hazard ratio for the development of AF', 'serum peak magnesium levels', 'Atrial fibrillation', 'atrial fibrillation (AF', 'mean duration of magnesium infusion']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0202125', 'cui_str': 'Magnesium measurement, serum'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]",99.0,0.324668,"The intervention group had greater serum peak magnesium levels: 1.72 mmol/L ± 0.34 on day 1, 1.32 ± 0.36 on day 2 versus 1.01 ± 1.14 and 0.97 ± 0.13, respectively, in the control group (p < 0.01).","[{'ForeName': 'Eduardo A', 'Initials': 'EA', 'LastName': 'Osawa', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia; Department of Cardiology, Heart Institute (InCor), Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Salvatore L', 'Initials': 'SL', 'LastName': 'Cutuli', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Fondazione Policlinico Universitario A. Gemelli, Universita Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cioccari', 'Affiliation': 'Department of Intensive Care Medicine, University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bitker', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Peck', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Young', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Hessels', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia; Department of Critical Care, University of Groningen, University Medical Center, Groningen, The Netherlands.'}, {'ForeName': 'Fumitaka', 'Initials': 'F', 'LastName': 'Yanase', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia; Australian and New Zealand Intensive Care Research Centre, Monash University, School of Public Health and Preventive Medicine, Melbourne, Australia.'}, {'ForeName': 'Julia T', 'Initials': 'JT', 'LastName': 'Fukushima', 'Affiliation': 'Department of Cardiology, Heart Institute (InCor), Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ludhmila A', 'Initials': 'LA', 'LastName': 'Hajjar', 'Affiliation': 'Department of Cardiology, Heart Institute (InCor), Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Siven', 'Initials': 'S', 'LastName': 'Seevanayagam', 'Affiliation': 'Department of Cardiac Surgery, Austin Hospital, Heidelberg, Melbourne, Australia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Matalanis', 'Affiliation': 'Department of Cardiac Surgery, Austin Hospital, Heidelberg, Melbourne, Australia.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Eastwood', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia; Centre for Integrated Critical Care, School of Medicine, The University of Melbourne, Melbourne, Australia. Electronic address: rinaldo.Bellomo@austin.org.au.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.04.006'] 582,32505383,"Treatment of endometriosis-associated pain with linzagolix, an oral gonadotropin-releasing hormone-antagonist: a randomized clinical trial.","OBJECTIVE To study the effect of a new investigational oral gonadotropin-releasing hormone antagonist, linzagolix, on endometriosis-associated pain (EAP). DESIGN A multinational, parallel group, randomized, placebo-controlled, double-blind, dose-ranging trial. SETTING Clinical centers. PATIENT(S) Women aged 18-45 years with surgically confirmed endometriosis and moderate-to-severe EAP. INTERVENTION(S) The interventions were 50, 75, 100, or 200 mg linzagolix (or matching placebo) administered once daily for 24 weeks. MAIN OUTCOME MEASURE(S) The primary endpoint was the number of responders (≥30% reduction in overall pelvic pain) after 12 weeks. Other endpoints included dysmenorrhea, non-menstrual pelvic pain, serum estradiol, amenorrhea, quality of life (QoL) measures, and bone mineral density (BMD). RESULT(S) Compared with placebo, doses ≥ 75 mg resulted in a significantly greater proportion of responders for overall pelvic pain at 12 weeks (34.5%, 61.5%, 56.4%, and 56.3% for placebo, 75, 100, and 200 mg, respectively). A similar pattern was seen for dysmenorrhea and non-menstrual pelvic pain. The effects were maintained or increased at 24 weeks. Serum estradiol was suppressed, QoL improved, and the rate of amenorrhea increased in a dose-dependent fashion. Mean BMD loss (spine) at 24 weeks was <1% at doses of 50 and 75 mg and increased in a dose-dependent fashion up to 2.6% for 200 mg. BMD of femoral neck and total hip showed a similar pattern. CONCLUSION(S) Linzagolix significantly reduced EAP and improved QoL at doses of 75-200 mg and decreased BMD dose-dependently. CLINICAL TRIAL REGISTRATION NUMBER NCT02778399.",2020,"Compared with placebo, doses ≥ 75 mg resulted in a significantly greater proportion of responders for overall pelvic pain at 12 weeks (34.5%, 61.5%, 56.4%, and 56.3% for placebo, 75, 100, and 200 mg, respectively).","['Clinical centers', 'Women aged 18-45 years with surgically confirmed endometriosis and moderate-to-severe EAP']","['oral gonadotropin-releasing hormone-antagonist', 'linzagolix (or matching placebo', 'gonadotropin-releasing hormone antagonist, linzagolix', 'placebo']","['EAP and improved QoL', 'Mean BMD loss (spine', 'BMD of femoral neck and total hip', 'proportion of responders for overall pelvic pain', 'number of responders', 'rate of amenorrhea', 'overall pelvic pain', 'dysmenorrhea, non-menstrual pelvic pain, serum estradiol, amenorrhea, quality of life (QoL) measures, and bone mineral density (BMD', 'dysmenorrhea and non-menstrual pelvic pain', 'Serum estradiol']","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0002453', 'cui_str': 'Amenorrhea'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.615483,"Compared with placebo, doses ≥ 75 mg resulted in a significantly greater proportion of responders for overall pelvic pain at 12 weeks (34.5%, 61.5%, 56.4%, and 56.3% for placebo, 75, 100, and 200 mg, respectively).","[{'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Donnez', 'Affiliation': ""Société de recherche pour l'infertilité, Catholic University of Louvain, Leuven, Belgium.""}, {'ForeName': 'Hugh S', 'Initials': 'HS', 'LastName': 'Taylor', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Robert N', 'Initials': 'RN', 'LastName': 'Taylor', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Akin', 'Affiliation': 'Austin Area Obstetrics Gynecology and Fertility, Austin, Texas.'}, {'ForeName': 'Tatyana F', 'Initials': 'TF', 'LastName': 'Tatarchuk', 'Affiliation': 'Department of Endocrine Gynecology, Institute of Pediatrics, Obstetrics and Gynecology of the NAMS of Ukraine, Kiev, Ukraine.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Wilk', 'Affiliation': 'Vita Longa Sp. z o.o, Katowice, Poland.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Gotteland', 'Affiliation': 'ObsEva S.A, Geneva, Switzerland.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Lecomte', 'Affiliation': 'ObsEva S.A, Geneva, Switzerland.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Bestel', 'Affiliation': 'ObsEva S.A, Geneva, Switzerland. Electronic address: elke.bestel@obseva.ch.'}]",Fertility and sterility,['10.1016/j.fertnstert.2020.02.114'] 583,32519676,Spelling Errors and Shouting Capitalization Lead to Additive Penalties to Trustworthiness of Online Health Information: Randomized Experiment With Laypersons.,"BACKGROUND The written format and literacy competence of screen-based texts can interfere with the perceived trustworthiness of health information in online forums, independent of the semantic content. Unlike in professional content, the format in unmoderated forums can regularly hint at incivility, perceived as deliberate rudeness or casual disregard toward the reader, for example, through spelling errors and unnecessary emphatic capitalization of whole words (online shouting). OBJECTIVE This study aimed to quantify the comparative effects of spelling errors and inappropriate capitalization on ratings of trustworthiness independently of lay insight and to determine whether these changes act synergistically or additively on the ratings. METHODS In web-based experiments, 301 UK-recruited participants rated 36 randomized short stimulus excerpts (in the format of information from an unmoderated health forum about multiple sclerosis) for trustworthiness using a semantic differential slider. A total of 9 control excerpts were compared with matching error-containing excerpts. Each matching error-containing excerpt included 5 instances of misspelling, or 5 instances of inappropriate capitalization (shouting), or a combination of 5 misspelling plus 5 inappropriate capitalization errors. Data were analyzed in a linear mixed effects model. RESULTS The mean trustworthiness ratings of the control excerpts ranged from 32.59 to 62.31 (rating scale 0-100). Compared with the control excerpts, excerpts containing only misspellings were rated as being 8.86 points less trustworthy, those containing inappropriate capitalization were rated as 6.41 points less trustworthy, and those containing the combination of misspelling and capitalization were rated as 14.33 points less trustworthy (P<.001 for all). Misspelling and inappropriate capitalization show an additive effect. CONCLUSIONS Distinct indicators of incivility independently and additively penalize the perceived trustworthiness of online text independently of lay insight, eliciting a medium effect size.",2020,The mean trustworthiness ratings of the control excerpts ranged from 32.59 to 62.31 (rating scale 0-100).,['301 UK-recruited participants rated 36'],"['inappropriate capitalization (shouting), or a combination of 5 misspelling plus 5 inappropriate capitalization errors', 'spelling errors and inappropriate capitalization', 'randomized short stimulus excerpts (in the format of information from an unmoderated health forum about multiple sclerosis) for trustworthiness using a semantic differential slider']",['mean trustworthiness ratings'],"[{'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}]","[{'cui': 'C3542467', 'cui_str': 'Inappropriate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0036611', 'cui_str': 'Differential, Semantic'}, {'cui': 'C1005353', 'cui_str': 'Trachemys'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0768117,The mean trustworthiness ratings of the control excerpts ranged from 32.59 to 62.31 (rating scale 0-100).,"[{'ForeName': 'Harry J', 'Initials': 'HJ', 'LastName': 'Witchel', 'Affiliation': 'Department of Neuroscience, Brighton and Sussex Medical School, Brighton, United Kingdom.'}, {'ForeName': 'Georgina A', 'Initials': 'GA', 'LastName': 'Thompson', 'Affiliation': 'Department of Neuroscience, Brighton and Sussex Medical School, Brighton, United Kingdom.'}, {'ForeName': 'Christopher I', 'Initials': 'CI', 'LastName': 'Jones', 'Affiliation': 'Department of Primary Care and Public Health, Brighton and Sussex Medical School, Brighton, United Kingdom.'}, {'ForeName': 'Carina E I', 'Initials': 'CEI', 'LastName': 'Westling', 'Affiliation': 'Faculty of Media and Communication, Bournemouth University, Bournemouth, United Kingdom.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Romero', 'Affiliation': 'Dalton Maag Ltd, London, United Kingdom.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Nicotra', 'Affiliation': 'Dalton Maag Ltd, London, United Kingdom.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Maag', 'Affiliation': 'Dalton Maag Ltd, London, United Kingdom.'}, {'ForeName': 'Hugo D', 'Initials': 'HD', 'LastName': 'Critchley', 'Affiliation': 'Department of Neuroscience, Brighton and Sussex Medical School, Brighton, United Kingdom.'}]",Journal of medical Internet research,['10.2196/15171'] 584,32520897,"Dynamic impact of transfusion ratios on outcomes in severely injured patients: Targeted machine learning analysis of the Pragmatic, Randomized Optimal Platelet and Plasma Ratios randomized clinical trial.","BACKGROUND Massive transfusion protocols to treat postinjury hemorrhage are based on predefined blood product transfusion ratios followed by goal-directed transfusion based on patient's clinical evolution. However, it remains unclear how these transfusion ratios impact patient outcomes over time from injury. METHODS The Pragmatic, Randomized Optimal Platelet and Plasma Ratios (PROPPR) is a phase 3, randomized controlled trial, across 12 Level I trauma centers in North America. From 2012 to 2013, 680 severely injured patients required massive transfusion. We used semiparametric machine learning techniques and causal inference methods to augment the intent-to-treat analysis of PROPPR, estimating the dynamic relationship between transfusion ratios and outcomes: mortality and hemostasis at different timepoints during the first 24 hours after admission. RESULTS In the intention-to-treat analysis, the 1:1:1 group tended to have decreased mortality, but with no statistical significance. For patients in whom hemostasis took longer than 2 hours, the 1:1:1 ratio was associated with a higher probability of hemostasis, statistically significant from the 4 hour on. In the per-protocol, actual-transfusion-ratios-received analysis, during four successive time intervals, no significant association was found between the actual ratios and mortality. When comparing patient groups who received both high plasma/PRBC and high platelet/PRBC ratios to the group of low ratios in both, the relative risk of achieving hemostasis was 2.49 (95% confidence interval, 1.19-5.22) during the third hour after admission, suggesting a significant beneficial impact of higher transfusion ratios of plasma and platelets on hemostasis. CONCLUSION Our results suggest that the impact of transfusion ratios on hemostasis is dynamic. Overall, the transfusion ratios had no significant impact on mortality over time. However, receiving higher ratios of platelets and plasma relative to red blood cells hastens hemostasis in subjects who have yet to achieve hemostasis within 3 hours after hospital admission. LEVEL OF EVIDENCE Therapeutic IV.",2020,"Overall, the transfusion ratios had no significant impact on mortality over time.","['680 severely injured patients required massive transfusion', 'Severely Injured Patients', '12 level-I trauma centers in North America']",['Transfusion Ratios'],"['relative risk of achieving hemostasis', 'mortality', 'probability of hemostasis', 'actual ratios and mortality']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0028405', 'cui_str': 'North America'}]","[{'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",680.0,0.326126,"Overall, the transfusion ratios had no significant impact on mortality over time.","[{'ForeName': 'Minh', 'Initials': 'M', 'LastName': 'Nguyen', 'Affiliation': 'From the Division of Epidemiology and Biostatistics (M.N., J.C., A.H.), School of Public Health, University of California, Berkeley; Department of Anesthesia and Perioperative Care (R.P.), Department of Surgery (L.Z.K., R.C.), School of Medicine, University of California, San Francisco, California; Division of Acute Care Surgery, Department of Surgery (E.E.F.), Medical School, Center for Translational Injury Research, Department of Surgery (C.E.W., J.B.H.), Center for Translational Injury Research, Medical School, University of Texas Health Science Center, Houston, Texas; Division of Trauma, Critical Care and Acute Care Surgery, School of Medicine (M.S.), Oregon Health & Science University, Portland, Oregon; and Department of Surgery, School of Medicine (M.C.), University of Colorado, Boulder, Colorado.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Pirracchio', 'Affiliation': ''}, {'ForeName': 'Lucy Z', 'Initials': 'LZ', 'LastName': 'Kornblith', 'Affiliation': ''}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Callcut', 'Affiliation': ''}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Fox', 'Affiliation': ''}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Wade', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schreiber', 'Affiliation': ''}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Holcomb', 'Affiliation': ''}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Coyle', 'Affiliation': ''}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Hubbard', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002819'] 585,31454561,Mobile health and supervised rehabilitation versus mobile health alone in breast cancer survivors: Randomized controlled trial.,"BACKGROUND Survival rates in cancer are increasing exponentially, with a corresponding increase/influence in disability-adjusted life-years. Efforts should be made to explore the optimal balance between unsupervised/distance-based and supervised/onsite approaches to cancer care. OBJECTIVE This study aimed to compare the clinical efficacy of the BENECA mobile Health (mHealth) lifestyle application combined with a supervised rehabilitation program (BENECA and supervised rehabilitation) versus the BENECA mHealth lifestyle application alone on quality of life (QoL) and functional outcomes of breast cancer survivors. METHODS This randomized controlled trial included 80 survivors of breast cancer diagnosed at stage I-IIIA, who completed adjuvant therapy and were overweight or obese at diagnosis. Participants were randomly allocated (ratio 1:1, 3 waves) to BENECA mHealth and rehabilitation for 2months (n=40) or BENECA mHealth and usual care (BENECA mHealth alone; n=40). Participants completed a questionnaire at baseline (T1), 8-weeks post-intervention (T2) and 6-month follow-up (T3). The primary outcome was QoL assessed with the EORT QLQ-C30. Secondary outcomes included upper-limb functionality and body composition. Statistical (between-group analyses of covariance) and clinical effects were analyzed by intention to treat. RESULTS Both groups showed improved outcomes, but global QoL was significantly better with BENECA mHealth and rehabilitation than BENECA mHealth alone (mean difference, 12.76; 95% confidence interval 4.85; 20.67; P=0.004), with a moderate-to-large effect size (d=72). The proportion of participants reporting reliable clinical improvement on global QoL at T2 was higher with BENECA mHealth and rehabilitation than BENECA mHealth alone (57.5% vs 26.3%, P=0.008). Improvement in subjective and objective upper-limb functionality was also higher with BENECA mHealth and rehabilitation. CONCLUSIONS The BENECA mHealth lifestyle application with a supervised rehabilitation program had a statistically and clinically significant effect on QoL and upper-limb functionality in breast cancer survivors and is a unique and important promising new approach.",2020,The BENECA mHealth lifestyle application with a supervised rehabilitation program had a statistically and clinically significant effect on QoL and upper-limb functionality in breast cancer survivors and is a unique and important promising new approach.,"['breast cancer survivors', '80 survivors of breast cancer diagnosed at stage I-IIIA, who completed adjuvant therapy and were overweight or obese at diagnosis']","['supervised rehabilitation program', 'BENECA mobile Health (mHealth) lifestyle application combined with a supervised rehabilitation program (BENECA and supervised rehabilitation', 'BENECA mHealth and rehabilitation for 2 months (n=40) or BENECA mHealth and usual care (BENECA mHealth alone', 'Mobile health and supervised rehabilitation versus mobile health alone']","['QoL assessed with the EORT QLQ-C30', 'quality of life (QoL) and functional outcomes', 'global QoL', 'QoL and upper-limb functionality', 'upper-limb functionality and body composition', 'subjective and objective upper-limb functionality']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0016712', 'cui_str': ""Freund's Adjuvant""}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0034380'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}]",80.0,0.132467,The BENECA mHealth lifestyle application with a supervised rehabilitation program had a statistically and clinically significant effect on QoL and upper-limb functionality in breast cancer survivors and is a unique and important promising new approach.,"[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Lozano-Lozano', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Avda. de la Ilustración, 60, 18016 Granada, Spain; Sport and Health Joint University Institute (iMUDS), Granada, Spain; Biohealth Research Institute in Granada (ibs.GRANADA), Granada, Spain; ""Cuídate"" Support Unit for Oncology Patients (UAPO-Cuídate), Granada, Spain.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Martín-Martín', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Avda. de la Ilustración, 60, 18016 Granada, Spain; Sport and Health Joint University Institute (iMUDS), Granada, Spain; Biohealth Research Institute in Granada (ibs.GRANADA), Granada, Spain; ""Cuídate"" Support Unit for Oncology Patients (UAPO-Cuídate), Granada, Spain.'}, {'ForeName': 'Noelia', 'Initials': 'N', 'LastName': 'Galiano-Castillo', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Avda. de la Ilustración, 60, 18016 Granada, Spain; Sport and Health Joint University Institute (iMUDS), Granada, Spain; Biohealth Research Institute in Granada (ibs.GRANADA), Granada, Spain; ""Cuídate"" Support Unit for Oncology Patients (UAPO-Cuídate), Granada, Spain. Electronic address: noeliagaliano@ugr.es.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Fernández-Lao', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Avda. de la Ilustración, 60, 18016 Granada, Spain; Sport and Health Joint University Institute (iMUDS), Granada, Spain; Biohealth Research Institute in Granada (ibs.GRANADA), Granada, Spain; ""Cuídate"" Support Unit for Oncology Patients (UAPO-Cuídate), Granada, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Cantarero-Villanueva', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Avda. de la Ilustración, 60, 18016 Granada, Spain; Sport and Health Joint University Institute (iMUDS), Granada, Spain; Biohealth Research Institute in Granada (ibs.GRANADA), Granada, Spain; ""Cuídate"" Support Unit for Oncology Patients (UAPO-Cuídate), Granada, Spain.'}, {'ForeName': 'Isabel B', 'Initials': 'IB', 'LastName': 'López-Barajas', 'Affiliation': '""San Cecilio"" University Hospital, Oncology Unit, Granada, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Arroyo-Morales', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Avda. de la Ilustración, 60, 18016 Granada, Spain; Sport and Health Joint University Institute (iMUDS), Granada, Spain; Biohealth Research Institute in Granada (ibs.GRANADA), Granada, Spain; ""Cuídate"" Support Unit for Oncology Patients (UAPO-Cuídate), Granada, Spain.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2019.07.007'] 586,31894238,Developing preliminary blood metabolomics-based biomarkers of insufficient sleep in humans.,"STUDY OBJECTIVE Identify small molecule biomarkers of insufficient sleep using untargeted plasma metabolomics in humans undergoing experimental insufficient sleep. METHODS We conducted a crossover laboratory study where 16 normal-weight participants (eight men; age 22 ± 5 years; body mass index < 25 kg/m2) completed three baseline days (9 hours sleep opportunity per night) followed by 5-day insufficient (5 hours sleep opportunity per night) and adequate (9 hours sleep opportunity per night) sleep conditions. Energy balanced diets were provided during baseline, with ad libitum energy intake provided during the insufficient and adequate sleep conditions. Untargeted plasma metabolomics analyses were performed using blood samples collected every 4 hours across the final 24 hours of each condition. Biomarker models were developed using logistic regression and linear support vector machine (SVM) algorithms. RESULTS The top-performing biomarker model was developed by linear SVM modeling, consisted of 65 compounds, and discriminated insufficient versus adequate sleep with 74% overall accuracy and a Matthew's Correlation Coefficient of 0.39. The compounds in the top-performing biomarker model were associated with ATP Binding Cassette Transporters in Lipid Homeostasis, Phospholipid Metabolic Process, Plasma Lipoprotein Remodeling, and sphingolipid metabolism. CONCLUSION We identified potential metabolomics-based biomarkers of insufficient sleep in humans. Although our current biomarkers require further development and validation using independent cohorts, they have potential to advance our understanding of the negative consequences of insufficient sleep, improve diagnosis of poor sleep health, and could eventually help identify targets for countermeasures designed to mitigate the negative health consequences of insufficient sleep.",2020,"The compounds in the top performing biomarker model were associated with ATP Binding Cassette Transporters in Lipid Homeostasis, Phospholipid Metabolic Process, Plasma Lipoprotein Remodeling, and sphingolipid metabolism. ","['humans', 'humans undergoing experimental insufficient sleep', '16 normal weight participants (8 men; age 22 ± 5 years; body mass index < 25 kg/m2) completed three baseline days (9h sleep opportunity per night) followed by five day insufficient (5h sleep opportunity per night) and adequate (9h sleep opportunity per night) sleep conditions']",[],[],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0231180', 'cui_str': 'Insufficient'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",[],[],65.0,0.0196736,"The compounds in the top performing biomarker model were associated with ATP Binding Cassette Transporters in Lipid Homeostasis, Phospholipid Metabolic Process, Plasma Lipoprotein Remodeling, and sphingolipid metabolism. ","[{'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Depner', 'Affiliation': 'Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO.'}, {'ForeName': 'Dasha T', 'Initials': 'DT', 'LastName': 'Cogswell', 'Affiliation': 'Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Bisesi', 'Affiliation': 'Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO.'}, {'ForeName': 'Rachel R', 'Initials': 'RR', 'LastName': 'Markwald', 'Affiliation': 'Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO.'}, {'ForeName': 'Charmion', 'Initials': 'C', 'LastName': 'Cruickshank-Quinn', 'Affiliation': 'Skaggs School of Pharmacology, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Quinn', 'Affiliation': 'Skaggs School of Pharmacology, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Melanson', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Nichole', 'Initials': 'N', 'LastName': 'Reisdorph', 'Affiliation': 'Skaggs School of Pharmacology, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Kenneth P', 'Initials': 'KP', 'LastName': 'Wright', 'Affiliation': 'Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO.'}]",Sleep,['10.1093/sleep/zsz321'] 587,31473598,"Lack of effects of evidence-based, individualised counselling on medication use in insured patients with mild hypertension in China: a randomised controlled trial.","OBJECTIVE To evaluate whether evidence-based, individualised (EBI) counselling regarding hypertension and the treatment would affect medication use in insured patients with mild hypertension in China. METHODS We conducted a parallel-group, randomised controlled trial in two primary care centres in Shenzhen, a metropolitan city in China. Patients with mild primary hypertension, 10-year risk of cardiovascular diseases (CVDs) lower than 20% and no history of CVDs were recruited and randomly allocated to two groups. EBI plus general counselling was provided to the intervention group and general counselling alone to the control group. EBI counselling included information on the 10-year CVD risk and treatment benefit in terms of absolute risk reduction estimated for each individual and information on average side effects and costs of antihypertensive drugs. The outcomes included use of antihypertensive drugs and adherence to the treatment at 6-month follow-up, with the former being primary outcome. RESULTS Two hundred and ten patients were recruited, with 103 and 107 allocated to the intervention and control groups, respectively. At baseline, 62.4% of the patients were taking antihypertensive drugs that were all covered by health insurance. At the end of 6-month follow-up, there was no statistically significant difference in the rate of medication use between the intervention group and the control group (65.0% vs 57.9%; OR=1.35, 95% CI: 0.77 to 2.36). The difference in adherence rate between the two groups was not statistically significant either (43.7% vs 40.2%; OR=1.15, 95% CI 0.67 to 2.00]). The results were robust in sensitivity analyses that used different cutoffs to define the two outcomes. CONCLUSIONS The EBI counselling by health educators other than the caring physicians had little impact on treatment choices and drug-taking behaviours in insured patients with mild primary hypertension in this study. It remains unclear whether EBI counselling would make a difference in uninsured patients, especially when conducted by the caring physicians. TRIAL REGISTRATION NUMBER ChiCTR-TRC-14004169.",2020,"At the end of 6-month follow-up, there was no statistically significant difference in the rate of medication use between the intervention group and the control group (65.0% vs 57.9%; OR=1.35, 95% CI: 0.77 to 2.36).","['insured patients with mild primary hypertension', 'two primary care centres in Shenzhen, a metropolitan city in China', 'insured patients with mild hypertension in China', 'Two hundred and ten patients were recruited, with 103 and 107 allocated to the intervention and control groups, respectively', 'Patients with mild primary hypertension, 10-year risk of cardiovascular diseases (CVDs) lower than 20% and no history of CVDs']","['individualised (EBI) counselling', 'individualised counselling']","['adherence rate', 'rate of medication use', '10-year CVD risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0085580', 'cui_str': 'Essential Hypertension'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0332122', 'cui_str': 'No history of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",210.0,0.163999,"At the end of 6-month follow-up, there was no statistically significant difference in the rate of medication use between the intervention group and the control group (65.0% vs 57.9%; OR=1.35, 95% CI: 0.77 to 2.36).","[{'ForeName': 'Mengyang', 'Initials': 'M', 'LastName': 'Di', 'Affiliation': 'Department of Medicine, Rhode Island Hospital, Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Mao', 'Affiliation': 'Department of Epidemiology, School of Public Health, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Zuyao', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Division of Epidemiology, School of Public Health and Primary Care, Chinese University of Hong Kong, New Territories, Hong Kong.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Ding', 'Affiliation': 'Longgang Center for Disease Control and Prevention, Shenzhen, China.'}, {'ForeName': 'Qu', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Longgang Center for Disease Control and Prevention, Shenzhen, China.'}, {'ForeName': 'Shuiming', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Longgang Center for Disease Control and Prevention, Shenzhen, China.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': ""Central City Community Healthcare Centre, Longgang People's Hospital, Shenzhen, China.""}, {'ForeName': 'Kunhua', 'Initials': 'K', 'LastName': 'Jiang', 'Affiliation': ""Ziwei Garden Community Healthcare Centre, Longgang People's Hospital, Shenzhen, China.""}, {'ForeName': 'Jinling', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Division of Epidemiology, School of Public Health and Primary Care, Chinese University of Hong Kong, New Territories, Hong Kong jltang@cuhk.edu.hk.'}]",BMJ evidence-based medicine,['10.1136/bmjebm-2019-111197'] 588,31354055,Magnetic Resonance Imaging Pilot Study of Intravenous Glyburide in Traumatic Brain Injury.,"Pre-clinical studies of traumatic brain injury (TBI) show that glyburide reduces edema and hemorrhagic progression of contusions. We conducted a small Phase II, three-institution, randomized placebo-controlled trial of subjects with TBI to assess the safety and efficacy of intravenous (IV) glyburide. Twenty-eight subjects were randomized and underwent a 72-h infusion of IV glyburide or placebo, beginning within 10 h of trauma. Of the 28 subjects, 25 had Glasgow Coma Scale (GCS) scores of 6-10, and 14 had contusions. There were no differences in adverse events (AEs) or severe adverse events (ASEs) between groups. The magnetic resonance imaging (MRI) percent change at 72-168 h from screening/baseline was compared between the glyburide and placebo groups. Analysis of contusions (7 per group) showed that lesion volumes (hemorrhage plus edema) increased 1036% with placebo versus 136% with glyburide ( p  = 0.15), and that hemorrhage volumes increased 11.6% with placebo but decreased 29.6% with glyburide ( p  = 0.62). Three diffusion MRI measures of edema were quantified: mean diffusivity (MD), free water (FW), and tissue MD (MDt), corresponding to overall, extracellular, and intracellular water, respectively. The percent change with time for each measure was compared in lesions ( n  = 14) versus uninjured white matter ( n  = 24) in subjects receiving placebo ( n  = 20) or glyburide ( n  = 18). For placebo, the percent change in lesions for all three measures was significantly different compared with uninjured white matter (analysis of variance [ANOVA], p  < 0.02), consistent with worsening of edema in untreated contusions. In contrast, for glyburide, the percent change in lesions for all three measures was not significantly different compared with uninjured white matter. Further study of IV glyburide in contusion TBI is warranted.",2020,There were no differences in adverse events (AEs) or severe adverse events (ASEs) between groups.,"['Traumatic Brain Injury', 'subjects with TBI', 'Twenty-eight subjects']","['glyburide or placebo', 'glyburide', 'intravenous (IV) glyburide', 'placebo', 'Intravenous Glyburide', 'glyburide and placebo']","['adverse events (AEs) or severe adverse events (ASEs', 'lesion volumes (hemorrhage plus edema', 'hemorrhage volumes', 'mean diffusivity (MD), free water (FW), and tissue MD (MDt), corresponding to overall, extracellular, and intracellular water, respectively', 'Glasgow Coma Scale (GCS) scores', 'worsening of edema', 'safety and efficacy']","[{'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C4283787', 'cui_str': '28'}]","[{'cui': 'C0017628', 'cui_str': 'glibenclamide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0521119', 'cui_str': 'Extracellular (qualifier value)'}, {'cui': 'C0178719', 'cui_str': 'Intracellular (qualifier value)'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",28.0,0.435742,There were no differences in adverse events (AEs) or severe adverse events (ASEs) between groups.,"[{'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Eisenberg', 'Affiliation': 'Department of Neurosurgery, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Martha E', 'Initials': 'ME', 'LastName': 'Shenton', 'Affiliation': ""Departments of Psychiatry and Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Ofer', 'Initials': 'O', 'LastName': 'Pasternak', 'Affiliation': ""Departments of Psychiatry and Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'J Marc', 'Initials': 'JM', 'LastName': 'Simard', 'Affiliation': 'Department of Neurosurgery, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Okonkwo', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Aldrich', 'Affiliation': 'Department of Neurosurgery, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'He', 'Affiliation': 'Department of Family Medicine and Public Health, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Department of Family Medicine and Public Health, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Erik G', 'Initials': 'EG', 'LastName': 'Hayman', 'Affiliation': 'Department of Neurosurgery, University of Maryland School of Medicine, Baltimore, Maryland.'}]",Journal of neurotrauma,['10.1089/neu.2019.6538'] 589,32440816,"Omega-3 fatty acids reduce post-operative risk of deep vein thrombosis and pulmonary embolism after surgery for elderly patients with proximal femoral fractures: a randomized placebo-controlled, double-blind clinical trial.","BACKGROUND Elderly patients with proximal femoral fractures face elevated risk of post-operative deep vein thrombosis and pulmonary embolism, due to the lack of suitable treatment plans after surgery and hospital discharge. This study aimed to investigate the effect of omega-3 fatty acid supplementation in the above-described clinical setting. METHODS Five hundred and seven elderly patients (> 60 years of age) suffering from proximal femoral fractures were recruited. After exclusion, 452 eligible patients were assigned in a random manner to receive either omega-3 fatty acids at the daily dose of 1000 mg or placebo, via oral administration for a period of 30 days after surgery. At the end of intervention, the incidences of pulmonary embolism, deep vein thrombosis, and other related complications were compared between the two study groups. RESULTS Incidences of pulmonary embolism as well as deep vein thrombosis, including events leading to fatality, were significantly reduced by the 30-day omega-3 fatty acid intervention. But other related complications, such as haematoma evacuation, post-operative wound bleed, wound infection with frank pus, and other bleed events that required transfusion, were not affected after omega-3 fatty acid consumption. CONCLUSION Daily supplementation of omega-3 fatty acids decreases the risk of pulmonary embolism as well as symptomatic deep vein thrombosis, after surgery among elderly patients with proximal femoral fractures, without causing elevated risk of bleeding episodes.",2020,"RESULTS Incidences of pulmonary embolism as well as deep vein thrombosis, including events leading to fatality, were significantly reduced by the 30-day omega-3 fatty acid intervention.","['elderly patients with proximal femoral fractures', '452 eligible patients', 'Elderly patients with proximal femoral fractures', 'Five hundred and seven elderly patients (> 60 years of age) suffering from proximal femoral fractures were recruited']","['omega-3 fatty acids', 'Omega-3 fatty acids', 'omega-3 fatty acids at the daily dose of 1000 mg or placebo', 'omega-3 fatty acid supplementation', 'placebo']","['risk of pulmonary embolism', 'incidences of pulmonary embolism, deep vein thrombosis, and other related complications', 'deep vein thrombosis']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015802', 'cui_str': 'Fracture of femur'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",507.0,0.273138,"RESULTS Incidences of pulmonary embolism as well as deep vein thrombosis, including events leading to fatality, were significantly reduced by the 30-day omega-3 fatty acid intervention.","[{'ForeName': 'Xinying', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'Department of Nursing, Cangzhou Central Hospital, Xinhua West Road, Cangzhou, 061000, Hebei, China.'}, {'ForeName': 'Rufu', 'Initials': 'R', 'LastName': 'Jia', 'Affiliation': 'Department of Nursing, Cangzhou Central Hospital, Xinhua West Road, Cangzhou, 061000, Hebei, China. Hlbzxy2@163.com.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesia of West Hospital, Cangzhou Central Hospital, Xinhua West Road, Cangzhou, 061000, Hebei, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesia of West Hospital, Cangzhou Central Hospital, Xinhua West Road, Cangzhou, 061000, Hebei, China.'}, {'ForeName': 'Zhijing', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesia of West Hospital, Cangzhou Central Hospital, Xinhua West Road, Cangzhou, 061000, Hebei, China.'}]",International orthopaedics,['10.1007/s00264-020-04610-0'] 590,32171812,Suberythemic and erythemic doses of a 308-nm excimer laser treatment of stable vitiligo in combination with topical tacrolimus: A randomized controlled trial.,,2020,,[],"['308-nm excimer laser treatment', 'topical tacrolimus']",[],[],"[{'cui': 'C0392265', 'cui_str': 'Lasers, Excimer'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}]",[],,0.160899,,"[{'ForeName': 'Jung Min', 'Initials': 'JM', 'LastName': 'Bae', 'Affiliation': ""Department of Dermatology, St Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea.""}, {'ForeName': 'Soo Hyun', 'Initials': 'SH', 'LastName': 'Kwon', 'Affiliation': 'Department of Dermatology, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Hyun Jeong', 'Initials': 'HJ', 'LastName': 'Ju', 'Affiliation': ""Department of Dermatology, St Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea.""}, {'ForeName': 'Hee Young', 'Initials': 'HY', 'LastName': 'Kang', 'Affiliation': 'Department of Dermatology, Ajou University School of Medicine, Suwon, Korea. Electronic address: hykang@ajou.ac.kr.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.03.009'] 591,7524255,Retracted: Influence of volume replacement with different HES-solutions on microcirculatory blood flow in cardiac surgery.,"A variety of hydroxyethyl starch HES preparations with different molecular weight average (Mw) and molar substitution (MS) is available for volume replacement during acute normovolemic haemodilution (ANH). Particularly with regard to microcirculation, the ideal solution for volume therapy has not been found. The influence of four different HES preparations on macro- and microcirculation was investigated in 40 patients scheduled for elective aorto-coronary bypass grafting and undergoing ANH (preoperative withdrawn blood: 10 ml.kg-1): 1) 6% HES with Mw of 450,000 dalton and MS of 0.7; 2) 6% HES with Mw of 200,000 dalton and MS of 0.5; 3) 6% HES with Mw of 200,000 dalton and MS of 0.62; 4) 6% HES with Mw of 40,000 dalton and MS of 0.5. A 5th group without ANH served as a control (10 patients in each group). In addition to systemic haemodynamics and various laboratory parameters, skin capillary blood flow was measured by laser Doppler flowmetry. Laser Doppler flow (LDF) was monitored simultaneously at the patient's forehead and forearm. Changes in systemic haemodynamics were similar in all ANH-patients. Systemic vascular resistance (SVR) was lowest after infusion of HES 200/0.5. The most pronounced increase in plasma viscosity was in patients of group 1 (450/0.7) (P < 0.05) and plasma viscosity remained highest during the entire investigation period in these patients. After ANH, skin capillary blood flow measured at the forehead decreased in all patients except in patients of group 2 (200/0.5: max. +18%). Group 3 (200/0.62) showed the highest decrease in forehead-LDF. During CPB, forehead-LDF decreased significantly in groups 3 (200/0.62) and 4 (40/0.5).(ABSTRACT TRUNCATED AT 250 WORDS)",1994,"After ANH, skin capillary blood flow measured at the forehead decreased in all patients except in patients of group 2 (200/0.5: max.","['cardiac surgery', '40 patients scheduled for elective aorto-coronary bypass grafting and undergoing ANH (preoperative withdrawn blood: 10 ml.kg-1']","['Laser Doppler flow (LDF', 'HES preparations', 'HES-solutions', 'hydroxyethyl starch HES preparations']","['skin capillary blood flow', 'systemic haemodynamics', 'microcirculatory blood flow', 'plasma viscosity', 'systemic haemodynamics and various laboratory parameters, skin capillary blood flow', 'molecular weight average (Mw) and molar substitution (MS', 'Systemic vascular resistance (SVR', 'forehead-LDF', 'macro- and microcirculation']","[{'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0005768'}]","[{'cui': 'C0430489', 'cui_str': 'Laser doppler (procedure)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0020352', 'cui_str': 'hydroxyethylstarch'}]","[{'cui': 'C0221919', 'cui_str': 'Structure of capillary of skin'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C1287278', 'cui_str': 'Finding of plasma viscosity (finding)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C1258192', 'cui_str': 'Total Peripheral Resistance'}, {'cui': 'C0016540', 'cui_str': 'Forehead'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}]",40.0,0.031148,"After ANH, skin capillary blood flow measured at the forehead decreased in all patients except in patients of group 2 (200/0.5: max.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Boldt', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Justus-Liebig-University Giessen, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Zickmann', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Rapin', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hammermann', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Dapper', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Hempelmann', 'Affiliation': ''}]",Acta anaesthesiologica Scandinavica,[] 592,32506733,Methylene blue vs methyl aminolevulinate photodynamic therapy in combination with oral terbinafine in the treatment of severe dermatophytic toenail onychomycosis: Short- and long-term effects.,"BACKGROUND Photodynamic therapy (PDT) kills target microorganisms via reactive oxygen species (ROS) production. PDT seems to be a good alternative treatment option for onychomycosis. OBJECTIVE To compare the efficacy of combined therapies based on oral terbinafine (TN) plus adjunctive PDT mediated by methylene blue (MB) (TN + MB/PDT) or methyl aminolevulinate (MAL) (TN + MAL/PDT) in the treatment of onychomycosis. METHODS Twenty patients affected by severe dermatophyte onychomycosis in the nails of the big toe (>60% disease involvement of target nail) received oral TN for 12 weeks and concomitantly were randomly allocated to receive nine sessions, separated by 2-week intervals, of urea (40%) plus a PDT protocol mediated by MB (TN + MB/PDT: group I) or mediated by MAL (TN + MAL/PDT: group II). Clinical and mycological efficacy was evaluated at 16-, 40- and 52-week follow-up. RESULTS Both protocols showed a significant decrease in Onychomycosis Severity Index (OSI) scores (P < .05), from 24.2 ± 4.6 to 0.7 ± 0.6 (group I)) and from 18.5 ± 10.1 to 2.1 ± 2.0 (group II). No side effects or complications were reported in any of the combinations used. Mycological cure rates were significantly higher during the last third of the evaluated period of time, reaching 100% and 90% in group I and group II, respectively, at the 52-week follow-up. In both modalities, complete cure was achieved in 70% of the patients at the 52-week follow-up. CONCLUSIONS TN + MB/PDT and TN + MAL/PDT show similar outcomes in the treatment of toenails with severe onychomycosis. PDT is an effective method to accelerate the TN-mediated healing process.",2020,"Both protocols showed a significant decrease in Onychomycosis Severity Index (OSI) scores (p<0.05), from 24.2±4.6 to 0.7±0.6 (group I)) and from 18.5±10.1 to 2.1±2.0 (group II).","['toenails with severe onychomycosis', 'severe dermatophytic toenail onychomycosis', 'Twenty patients affected by severe dermatophyte onychomycosis in the nails of the big toe (>60% disease involvement of target nail) received oral TN for 12 weeks and concomitantly']","['PDT protocol mediated by MB (TN+MB/PDT: group I) or mediated by MAL (TN+MAL/PDT', 'Photodynamic therapy (PDT', 'TN+MB/PDT and TN+MAL/PDT', 'terbinafine', 'PDT', 'Methylene blue vs. methyl aminolevulinate photodynamic therapy', 'terbinafine (TN) plus adjunctive PDT mediated by methylene blue (MB) (TN+MB/PDT) or methyl aminolevulinate (MAL) (TN+MAL/PDT']","['Onychomycosis Severity Index (OSI) scores', 'Mycological cure rates', 'complete cure', 'Clinical and mycological efficacy', 'side effects or complications']","[{'cui': 'C0222007', 'cui_str': 'Toenails'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040261', 'cui_str': 'Onychomycosis'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0011635', 'cui_str': 'Arthrodermataceae'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0018534', 'cui_str': 'Hallux structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0076110', 'cui_str': 'terbinafine'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C1134467', 'cui_str': 'methyl 5-aminolevulinate'}, {'cui': 'C0600157', 'cui_str': 'Aminolevulinate'}, {'cui': 'C0076110', 'cui_str': 'terbinafine'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0040261', 'cui_str': 'Onychomycosis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205467', 'cui_str': 'Mycologic'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",20.0,0.0247545,"Both protocols showed a significant decrease in Onychomycosis Severity Index (OSI) scores (p<0.05), from 24.2±4.6 to 0.7±0.6 (group I)) and from 18.5±10.1 to 2.1±2.0 (group II).","[{'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Alberdi', 'Affiliation': 'Private clinic of Dr. Alberdi, Madrid, Spain.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Gómez', 'Affiliation': 'Institute of Physical Chemistry Rocasolano, CSIC, Madrid, Spain.'}]",Mycoses,['10.1111/myc.13125'] 593,32507624,Beetroot juice supplementation increases concentric and eccentric muscle power output. Original investigation.,"OBJECTIVES Beetroot juice (BJ) supplementation has been reported to enhance skeletal muscle contractile function; however, it is currently unclear whether BJ supplementation elicits comparable improvements in power output during different types of skeletal muscle contractions. The purpose of the current study was to assess the effect of BJ supplementation on power output during concentric (CON) and eccentric (ECC) muscle contractions during a half-squat. DESIGN In a randomized, double-blind placebo-controlled crossover design, eighteen adult males (age: 22.8±4.9y) completed two experimental testing sessions 2.5h following the acute ingestion of 140mL nitrate-rich BJ concentrate or a placebo. METHODS Each experimental session comprised four sets of eight all-out half-squat repetitions with each set completed with a different moment intertia (0.025, 0.050, 0.075 and 0.100kg·m -2 ). RESULTS Compared to placebo, BJ supplementation increased mean power output (MP) during the CON (ES: 0.61-1.01) and ECC (ES: 0.54-0.89; all p<0.05) movement phases to a similar extent. Moreover, comparable increases in peak power output (PP) during the CON (ES: 0.86-1.24) and ECC (ES: 0.6-1.08; all p<0.05) movement phases were observed following BJ supplementation. CONCLUSION Acute BJ supplementation increased mean and peak lower limb power output in the concentric and eccentric movement phases of a half-squat. These findings improve understanding of the effects of BJ supplementation on skeletal muscle contractile function and might have implications for enhancing sports performance in events where muscle power output is a key performance determinant.",2021,"Compared to placebo, BJ supplementation increased mean power output (MP) during the CON (ES: 0.61-1.01) and ECC (ES: 0.54-0.89; all p<0.05) movement phases to a similar extent.",['eighteen adult males (age: 22.8±4.9y'],"['140mL nitrate-rich BJ concentrate or a placebo', 'Beetroot juice (BJ) supplementation', 'BJ supplementation', 'placebo, BJ supplementation', 'Beetroot juice supplementation', 'Acute BJ supplementation', 'placebo']","['peak power output (PP', 'mean and peak lower limb power output', 'mean power output (MP', 'concentric and eccentric muscle power output', 'power output during concentric (CON) and eccentric (ECC) muscle contractions']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C1562259', 'cui_str': 'Eccentric muscle contraction'}]",18.0,0.17935,"Compared to placebo, BJ supplementation increased mean power output (MP) during the CON (ES: 0.61-1.01) and ECC (ES: 0.54-0.89; all p<0.05) movement phases to a similar extent.","[{'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Rodríguez-Fernández', 'Affiliation': 'Faculty of Health Sciences, University Isabel I, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Castillo', 'Affiliation': 'Faculty of Health Sciences, University Isabel I, Spain. Electronic address: danicasti5@gmail.com.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Raya-González', 'Affiliation': 'Faculty of Health Sciences, University Isabel I, Spain.'}, {'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'Domínguez', 'Affiliation': 'Faculty of Health Sciences, University Isabel I, Spain.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Bailey', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, United Kingdom.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.05.018'] 594,32525517,Association of Weight-Adjusted Caffeine and β-Blocker Use With Ophthalmology Fellow Performance During Simulated Vitreoretinal Microsurgery.,"Importance Vitreoretinal surgery can be technically challenging and is limited by physiologic characteristics of the surgeon. Factors that improve accuracy and precision of the vitreoretinal surgeon are invaluable to surgical performance. Objectives To establish weight-adjusted cutoffs for caffeine and β-blocker (propranolol) intake and to determine their interactions in association with the performance of novice vitreoretinal microsurgeons. Design, Settings, and Participants This single-blind cross-sectional study of 15 vitreoretinal surgeons who had less than 2 years of surgical experience was conducted from September 19, 2018, to September 25, 2019, at a dry-laboratory setting. Five simulations were performed daily for 2 days. On day 1, performance was assessed after sequential exposure to placebo, low-dose caffeine (2.5 mg/kg), high-dose caffeine (5.0 mg/kg), and high-dose propranolol (0.6 mg/kg). On day 2, performance was assessed after sequential exposure to placebo, low-dose propranolol (0.2 mg/kg), high-dose propranolol (0.6 mg/kg), and high-dose caffeine (5.0 mg/kg). Interventions Surgical simulation tasks were repeated 30 minutes after masked ingestion of placebo, caffeine, or propranolol pills during the 2 days. Main Outcomes and Measures An Eyesi surgical simulator was used to assess surgical performance, which included surgical score (range, 0 [worst] to 700 [best]), task completion time, intraocular trajectory, and tremor rate (range, 0 [worst] to 100 [best]). The nonparametric Friedman test followed by Dunn-Bonferroni post hoc test was applied for multiple comparisons. Results Of 15 vitreoretinal surgeons, 9 (60%) were male, with a mean (SD) age of 29.6 (1.4) years and mean (SD) body mass index (calculated as weight in kilograms divided by height in meters squared) of 23.15 (2.9). Compared with low-dose propranolol, low-dose caffeine was associated with a worse total surgical score (557.0 vs 617.0; difference, -53.0; 95% CI, -99.3 to -6.7; P = .009), a lower antitremor maneuver score (55.0 vs 75.0; difference, -12.0; 95% CI, -21.2 to -2.8; P = .009), longer intraocular trajectory (2298.6 vs 2080.7 mm; difference, 179.3 mm; 95% CI, 1.2-357.3 mm; P = .048), and increased task completion time (14.9 minutes vs 12.7 minutes; difference, 2.3 minutes; 95% CI, 0.8-3.8 minutes; P = .048). Postcaffeine treatment with propranolol was associated with performance improvement; however, surgical performance remained inferior compared with low-dose propranolol alone for total surgical score (570.0 vs 617.0; difference, -51.0; 95% CI, -77.6 to -24.4; P = .01), tremor-specific score (50.0 vs 75.0; difference, -16.0; 95% CI, -31.8 to -0.2; P = .03), and intraocular trajectory (2265.9 mm vs 2080.7 mm; difference, 166.8 mm; 95% CI, 64.1-269.6 mm; P = .03). Conclusions and Relevance The findings suggest that performance of novice vitreoretinal surgeons was worse after receiving low-dose caffeine alone but improved after receiving low-dose propranolol alone. Their performance after receiving propranolol alone was better than after the combination of propranolol and caffeine. These results may be helpful for novice vitreoretinal surgeons to improve microsurgical performance.",2020,"Postcaffeine treatment with propranolol was associated with performance improvement; however, surgical performance remained inferior compared with low-dose propranolol alone for total surgical score (570.0 vs 617.0; difference, -51.0; 95% CI, -77.6 to -24.4; P = .01), tremor-specific score (50.0 vs 75.0; difference, -16.0; 95% CI, -31.8 to -0.2; P = .03), and intraocular trajectory (2265.9 mm vs 2080.7 mm; difference, 166.8 mm; 95% CI, 64.1-269.6 mm; P = .03). ","['15 vitreoretinal surgeons, 9 (60%) were male, with a mean (SD) age of 29.6 (1.4) years and mean (SD) body mass index (calculated as weight in kilograms divided by height in meters squared) of 23.15 (2.9', '15 vitreoretinal surgeons who had less than 2 years of surgical experience was conducted from September 19, 2018, to September 25, 2019, at a dry-laboratory setting']","['placebo, low-dose propranolol', 'Postcaffeine', 'placebo, low-dose caffeine', 'propranolol and caffeine', 'caffeine', 'placebo, caffeine, or propranolol pills', 'caffeine and β-blocker (propranolol', 'propranolol']","['intraocular trajectory', 'surgical performance, which included surgical score (range, 0', 'lower antitremor maneuver score', 'total surgical score', 'task completion time', 'tremor-specific score', 'longer intraocular trajectory', 'task completion time, intraocular trajectory, and tremor rate (range, 0 [worst] to 100 [best']","[{'cui': 'C1720040', 'cui_str': 'Retinal surgeon'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C4517641', 'cui_str': '2.9'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C3217257', 'cui_str': 'Propranolol Pill'}]","[{'cui': 'C1522223', 'cui_str': 'Intraocular route'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",5.0,0.394633,"Postcaffeine treatment with propranolol was associated with performance improvement; however, surgical performance remained inferior compared with low-dose propranolol alone for total surgical score (570.0 vs 617.0; difference, -51.0; 95% CI, -77.6 to -24.4; P = .01), tremor-specific score (50.0 vs 75.0; difference, -16.0; 95% CI, -31.8 to -0.2; P = .03), and intraocular trajectory (2265.9 mm vs 2080.7 mm; difference, 166.8 mm; 95% CI, 64.1-269.6 mm; P = .03). ","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Roizenblatt', 'Affiliation': 'Department of Ophthalmology, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Vitor', 'Initials': 'V', 'LastName': 'Dias Gomes Barrios Marin', 'Affiliation': 'Department of Ophthalmology, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alex Treiger', 'Initials': 'AT', 'LastName': 'Grupenmacher', 'Affiliation': 'Department of Ophthalmology, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Muralha', 'Affiliation': 'Department of Ophthalmology, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Faber', 'Affiliation': 'Department of Neurology and Neurosurgery, Neuroengineering and Neurocognition Laboratory, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Jiramongkolchai', 'Affiliation': 'Johns Hopkins University School of Medicine, The Wilmer Eye Institute, Baltimore, Maryland.'}, {'ForeName': 'Peter Louis', 'Initials': 'PL', 'LastName': 'Gehlbach', 'Affiliation': 'Johns Hopkins University School of Medicine, The Wilmer Eye Institute, Baltimore, Maryland.'}, {'ForeName': 'Michel Eid', 'Initials': 'ME', 'LastName': 'Farah', 'Affiliation': 'Department of Ophthalmology, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rubens', 'Initials': 'R', 'LastName': 'Belfort', 'Affiliation': 'Department of Ophthalmology, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Maia', 'Affiliation': 'Department of Ophthalmology, Universidade Federal de São Paulo, São Paulo, Brazil.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.1971'] 595,31482294,Metabolic changes with degarelix vs leuprolide plus bicalutamide in patients with prostate cancer: a randomized clinical study.,"PURPOSE In a mouse model, degarelix generated the least metabolic consequences via low follicle-stimulating hormone (FSH) levels compared with orchiectomy and leuprolide after 4 months of androgen deprivation therapy (ADT). Here, we comparatively investigated the influence of ADT with degarelix or leuprolide on the development of metabolic syndrome in patients with prostate cancer (PCa). METHODS Patients with hormone-naive PCa were recruited. Eligible patients were randomized (1:1) to monthly degarelix or monthly leuprolide for 6 months. Key trial variables were monitored monthly. The primary endpoint was changes in fasting blood sugar (FBS). Secondary endpoints were changes in body weight, abdominal circumference, lipid profiles, and hemoglobin A1c (HbA1c) and FSH levels. Computed tomography was performed to measure subcutaneous and visceral fat areas before and after 6 months of ADT. Data were analyzed using the χ 2 test, Student's t test, and analysis of variance. RESULTS From the 100 patients registered, 85 completed the trial (degarelix: 40 patients; leuprolide: 45 patients). Mean increases in FBS did not differ between the two arms. Similarly, there were no differences between the arms in mean increases in body weight, abdominal circumference, lipid profiles, HbA1c, or subcutaneous and visceral fat areas. Follicle-stimulating hormone levels were significantly lower in the degarelix arm than in the leuprolide arm (p < 0.05). CONCLUSIONS Lipid and glucose metabolism did not differ significantly between the arms, while FSH levels were significantly lower in the degarelix arm.",2020,"Lipid and glucose metabolism did not differ significantly between the arms, while FSH levels were significantly lower in the degarelix arm.","['patients with prostate cancer (PCa', 'Eligible patients', 'patients with prostate cancer', '100 patients registered, 85 completed the trial (degarelix: 40 patients', 'Patients with hormone-naive PCa were recruited']","['androgen deprivation therapy (ADT', 'orchiectomy and leuprolide', 'leuprolide', 'degarelix or monthly leuprolide', 'ADT with degarelix or leuprolide', 'degarelix vs leuprolide plus bicalutamide', 'degarelix']","['metabolic syndrome', 'Follicle-stimulating hormone levels', 'body weight, abdominal circumference, lipid profiles, HbA1c, or subcutaneous and visceral fat areas', 'FSH levels', 'FBS', 'changes in body weight, abdominal circumference, lipid profiles, and hemoglobin A1c (HbA1c) and FSH levels', 'Lipid and glucose metabolism', 'least metabolic consequences via low follicle-stimulating hormone (FSH) levels', 'fasting blood sugar (FBS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0585825', 'cui_str': 'Patient registered (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1455035', 'cui_str': 'degarelix'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}]","[{'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0029189', 'cui_str': 'Orchidectomy'}, {'cui': 'C0085272', 'cui_str': 'Leuprolide'}, {'cui': 'C1455035', 'cui_str': 'degarelix'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0285590', 'cui_str': 'bicalutamide'}]","[{'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement (procedure)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference (observable entity)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}]",85.0,0.051307,"Lipid and glucose metabolism did not differ significantly between the arms, while FSH levels were significantly lower in the degarelix arm.","[{'ForeName': 'Harutake', 'Initials': 'H', 'LastName': 'Sawazaki', 'Affiliation': 'Department of Urology, Tama-hokubu Medical Center, 1-7-1 Aobacho, Higashimurayama, Tokyo, 189-8511, Japan. harutake_sawazaki@tokyo-hmt.jp.'}, {'ForeName': 'Daiji', 'Initials': 'D', 'LastName': 'Araki', 'Affiliation': 'Department of Urology, Tama-hokubu Medical Center, 1-7-1 Aobacho, Higashimurayama, Tokyo, 189-8511, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Kitamura', 'Affiliation': 'Department of Urology, National Defense Medical College, Tokorozawa, Japan.'}, {'ForeName': 'Kota', 'Initials': 'K', 'LastName': 'Yagi', 'Affiliation': 'Department of Urology, National Defense Medical College, Tokorozawa, Japan.'}]",World journal of urology,['10.1007/s00345-019-02937-x'] 596,31451566,Falls and Cognitive Training 2 (FaCT2) study protocol: a randomised controlled trial exploring cognitive training to reduce risk of falls in at-risk older adults.,"BACKGROUND The primary cause of traumatic injury in older adults is fall. Recent reports suggest that cognitive function contributes significantly to fall risk. Therefore, by targeting cognitive function for intervention, we could potentially reduce the incidence of fall and injury. PRIMARY OBJECTIVE To explore the effectiveness of a 16-week cognitive training (CT) intervention to reduce risk and incidence of fall in community-dwelling older adults at risk for fall. OUTCOMES Primary outcome is number of falls over a 16-week period (ascertained by fall calendar method). Secondary outcomes include: change fall risk as indicated by improvement in 10 m walk and 90 s balance tests. DESIGN/METHODS The design is a two-group randomised controlled trial. Eligible participants are older adults (aged 65-85) residing in the community who are at risk for fall based on physical performance testing. Following completion of 1-week run-in phase, participants are randomly allocated (1:2) to either a group that is assigned to attention control or to the group that receives CT intervention for a total of 16 weeks. Participants are followed for an additional 4 weeks after intervention. Mann-Whitney U test and Student's t-test will be used to examine between-group differences using intention-to-treat analyses. DISCUSSION Limited evidence supports the potential of CT to improve cognition and gait, but no published study has evaluated whether such an intervention would reduce incidence of fall. The present trial is designed to provide initial answers to this question. CT may also improve functioning important in other activities (eg, driving), reducing overall risk of injury in elders. TRIAL REGISTRATION NUMBER NCT03190460.",2020,"CT may also improve functioning important in other activities (eg, driving), reducing overall risk of injury in elders. ","['older adults', 'at-risk older adults', 'community-dwelling older adults at risk for fall', 'Eligible participants are older adults (aged 65-85) residing in the community who are at risk for fall based on physical performance testing']","['CT', 'cognitive training', 'attention control or to the group that receives CT intervention', 'cognitive training (CT) intervention']","['number of falls over a 16-week period (ascertained by fall calendar method', ' change fall risk as indicated by improvement in 10 m walk and 90\u2009s balance tests', 'risk of falls']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2607857'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0575126', 'cui_str': 'Falls occurrence'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C1516147', 'cui_str': 'Calendar'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.0797019,"CT may also improve functioning important in other activities (eg, driving), reducing overall risk of injury in elders. ","[{'ForeName': 'Hilaire J', 'Initials': 'HJ', 'LastName': 'Thompson', 'Affiliation': 'Biobehavioral Nursing and Health Informatics, University of Washington Seattle Campus, Seattle, Washington, USA hilairet@uw.edu.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'McGough', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington Seattle Campus, Seattle, Washington, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Demiris', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}]",Injury prevention : journal of the International Society for Child and Adolescent Injury Prevention,['10.1136/injuryprev-2019-043332'] 597,32437191,Child skills training for attention-deficit/hyperactivity disorder (ADHD): A randomized controlled trial of structured dyadic behavior therapy (SDBT).,"This pilot study examined structured dyadic behavior therapy (SDBT) as a novel, child skills training intervention for attention-deficit/hyperactivity disorder (ADHD). The purpose of this study was to (a) pilot the feasibility of SDBT, a manualized, child skills training intervention, (b) determine the potential clinical benefits of SDBT as an independent psychotherapy for ADHD, and (c) examine parents' intervention acceptability. Children of 8-12 years of age with ADHD-combined type ( N = 34) were randomly assigned to either SDBT or an ""attention control"" condition receiving child-centered dyadic therapy (CCDT). SDBT targeted high-frequency behavioral and social demands often challenging for children with ADHD. CCDT provided nondirective, experiential psychotherapy without any contingency management methods. Descriptive data revealed a high level of treatment attendance and completion (90%) for both conditions. General linear modeling techniques (multivariate analysis of variance) examined group differences in ADHD outcomes. Results indicated statistically significant differences between the two groups, with greater ADHD symptom reduction for SDBT (Wilks' λ = .61), F (3, 30) = 6.36, p = .002, η p ² = .39. SDBT also demonstrated clinically meaningful changes, with ADHD symptom severity reduced below categorical levels of functional impairment. Despite superior behavioral outcomes for SDBT, intervention acceptability did not significantly differ for the two psychotherapies. Results support SDBT as a feasible, clinically promising, and acceptable intervention for ADHD. Parent satisfaction ratings suggest dyadic therapies may benefit participants beyond symptom reduction. Implications for intervention portability and treating ADHD without direct adult participation are discussed. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"Results indicated statistically significant differences between the two groups, with greater ADHD symptom reduction for SDBT","['attention-deficit/hyperactivity disorder (ADHD', 'Children of 8-12 years of age with ADHD-combined type ( N = 34', 'children with ADHD']","['SDBT or an ""attention control"" condition receiving child-centered dyadic therapy (CCDT', 'SDBT', 'child skills training intervention', 'structured dyadic behavior therapy (SDBT', 'Child skills training']",[],"[{'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0204525', 'cui_str': 'Individual psychotherapy'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],34.0,0.0342802,"Results indicated statistically significant differences between the two groups, with greater ADHD symptom reduction for SDBT","[{'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Curtis', 'Affiliation': 'Department of Pediatrics.'}, {'ForeName': 'Corey L', 'Initials': 'CL', 'LastName': 'Heath', 'Affiliation': 'Department of Pediatrics.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Hogan', 'Affiliation': 'Pediatric Medical Group.'}]","Psychotherapy (Chicago, Ill.)",['10.1037/pst0000294'] 598,31435732,Laparoscopy versus robotic-assisted pyeloplasty in children: preliminary results of a pilot prospective randomized controlled trial.,"PURPOSE The aim of this randomized controlled trial (RCT) is to compare the outcomes of conventional laparoscopic pyeloplasty (LP) versus robotic-assisted laparoscopic pyeloplasty (RALP) in the treatment of ureteropelvic junction obstruction (UPJO) in children. METHODS A total of 53 patients with UPJO were randomized as LP (Group 1, n: 27) and RALP (Group 2, n: 26). Redo cases and patients with anatomical abnormalities were excluded. Urinary ultrasound was performed at postoperative 3, 6 and 12 months; whereas, diuretic renal scintigraphy was performed at 1 year. Failure was defined as progressive hydronephrosis on ultrasound, decline in renal function, or symptom relapse. All parameters were statistically compared. RESULTS The mean age of the patients was 55.53 ± 57.25 months. There were no statistical differences between the groups in terms of patient gender, body mass index, laterality, preoperative renal function, renal pelvis antero-posterior diameter and presence of crossing vessel. Mean total operative time in LP group was longer than RALP (139 min vs 105 min, respectively, p = 0.001). The hospital stay was similar between the two groups. After a mean follow-up of 12.43 ± 5.34 months, the complication and success rates were found comparable. Only two patients required re-do pyeloplasty in LP group. The mean total cost of RALP procedure was approximately four times higher than LP. CONCLUSIONS This is the first RCT comparing LP and RALP in pediatric population. Both LP and RALP are safe and effective in children with comparable success and complication rates. Operative time was longer for LP; whereas, total cost was higher for RALP.",2020,"There were no statistical differences between the groups in terms of patient gender, body mass index, laterality, preoperative renal function, renal pelvis antero-posterior diameter and presence of crossing vessel.","['children', '53 patients with UPJO', 'ureteropelvic junction obstruction (UPJO) in children', 'pediatric population']","['LP and RALP', 'Laparoscopy versus robotic-assisted pyeloplasty', 'RALP', 'LP', 'diuretic renal scintigraphy', 'conventional laparoscopic pyeloplasty (LP) versus robotic-assisted laparoscopic pyeloplasty (RALP']","['progressive hydronephrosis on ultrasound, decline in renal function, or symptom relapse', 'hospital stay', 'Mean total operative time', 'total cost', 'mean total cost of RALP procedure', 'patient gender, body mass index, laterality, preoperative renal function, renal pelvis antero-posterior diameter and presence of crossing vessel', 'complication and success rates', 'Operative time']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521619', 'cui_str': 'Pelvi-ureteric junction obstruction'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0554139', 'cui_str': 'Reconstruction of ureteropelvic junction (procedure)'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C0034606', 'cui_str': 'Gamma Camera Imaging'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0812509', 'cui_str': 'Laparoscopic pyeloplasty'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0020295', 'cui_str': 'Hydronephrosis'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332304', 'cui_str': 'Laterality (attribute)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0227666', 'cui_str': 'Kidney Pelvis'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",,0.0536008,"There were no statistical differences between the groups in terms of patient gender, body mass index, laterality, preoperative renal function, renal pelvis antero-posterior diameter and presence of crossing vessel.","[{'ForeName': 'Mesrur Selcuk', 'Initials': 'MS', 'LastName': 'Silay', 'Affiliation': 'Department of Pediatric Urology, Istanbul Gelisim University & Istanbul Memorial Hospital, Istanbul, Turkey. selcuksilay@gmail.com.'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Danacioglu', 'Affiliation': 'Department of Urology, Istanbul Medeniyet University, Istanbul, Turkey.'}, {'ForeName': 'Kerem', 'Initials': 'K', 'LastName': 'Ozel', 'Affiliation': 'Department of Pediatric Surgery, Istanbul Medeniyet University, Istanbul, Turkey.'}, {'ForeName': 'M Ihsan', 'Initials': 'MI', 'LastName': 'Karaman', 'Affiliation': 'Department of Urology, Istanbul Medeniyet University, Istanbul, Turkey.'}, {'ForeName': 'Turhan', 'Initials': 'T', 'LastName': 'Caskurlu', 'Affiliation': 'Department of Urology, Istanbul Medeniyet University, Istanbul, Turkey.'}]",World journal of urology,['10.1007/s00345-019-02910-8'] 599,32134802,PHASE 2 STUDY OF THE SAFETY AND EFFICACY OF BRIMONIDINE DRUG DELIVERY SYSTEM (BRIMO DDS) GENERATION 1 IN PATIENTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION.,"PURPOSE To evaluate the safety and efficacy of Brimonidine Drug Delivery System (Brimo DDS), a biodegradable intravitreal implant, in the treatment of geographic atrophy (GA) secondary to age-related macular degeneration. METHODS Phase 2, randomized, multicenter, double-masked, 24-month study. Study eyes were treated (Day 1; Month 6 retreatment) with Brimo DDS 132 µg (n = 49), Brimo DDS 264 µg (n = 41), or sham procedure (n = 23). The primary timepoint for efficacy analysis was Month 12. RESULTS Mean GA area growth at Month 12 was 1.78 mm2, 1.59 mm2, and 2.19 mm2 in the Brimo DDS 132 µg, 264 µg, and sham groups, respectively. Geographic atrophy area growth was consistently smaller with Brimo DDS 132 and 264 µg than sham; between-group differences were significant (P ≤ 0.032) at Month 3. In patients with baseline lesion area ≥6 mm2 (two-thirds of patients), GA lesion area and effective radius growth was reduced with Brimo DDS 132 and 264 µg at Month 12 (P ≤ 0.050 vs. sham). Treatment-related adverse events were usually injection procedure-related. CONCLUSION Brimo DDS demonstrated a favorable safety profile and reduced GA lesion area growth at Month 3. Lesion growth at Month 12 was reduced in patients with baseline GA lesion area ≥6 mm2. The results support Phase 3 development.",2021,Geographic atrophy area growth was consistently smaller with Brimo DDS 132 and 264 µg than sham; between-group differences were significant (P ≤ 0.032) at Month 3.,['geographic atrophy (GA) secondary to age-related macular degeneration'],"['Brimonidine Drug Delivery System (Brimo DDS', 'Brimo']","['GA lesion area and effective radius growth', 'Lesion growth', 'BRIMO DDS', 'Mean GA area growth', 'safety and efficacy', 'favorable safety profile and reduced GA lesion area growth', 'Geographic atrophy area growth']","[{'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0242383', 'cui_str': 'Maculopathy, Age-Related'}]","[{'cui': 'C0525227', 'cui_str': 'brimonidine'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0107173', 'cui_str': 'Brimos'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C1306504', 'cui_str': 'Radius (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0107173', 'cui_str': 'Brimos'}, {'cui': 'C0010980', 'cui_str': 'Dapsone'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}]",,0.0740045,Geographic atrophy area growth was consistently smaller with Brimo DDS 132 and 264 µg than sham; between-group differences were significant (P ≤ 0.032) at Month 3.,"[{'ForeName': 'Baruch D', 'Initials': 'BD', 'LastName': 'Kuppermann', 'Affiliation': 'Gavin Herbert Eye Institute, University of California Irvine, Irvine, California.'}, {'ForeName': 'Sunil S', 'Initials': 'SS', 'LastName': 'Patel', 'Affiliation': 'West Texas Retina, Abilene, Texas.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Boyer', 'Affiliation': 'Retina-Vitreous Associates Medical Group, Los Angeles, California.'}, {'ForeName': 'Albert J', 'Initials': 'AJ', 'LastName': 'Augustin', 'Affiliation': 'Department of Ophthalmology, Staedtisches Klinikum Karlsruhe, Karlsruhe, Germany.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Freeman', 'Affiliation': 'Jacobs Retina Center, University of California San Diego, San Diego, California; and.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Kerr', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Guo', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Schneider', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'López', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002789'] 600,32502795,Comparison of underwater gait training and overground gait training for improving the walking and balancing ability of patients with severe hemiplegic stroke: A randomized controlled pilot trial.,"BACKGROUND Walking training is an essential intervention to improve the function in stroke patients. However, only a limited number of gait training strategies are available for stroke patients with relatively severe disabilities. RESEARCH QUESTION Is underwater gait training or overground gait training more effective in severe stroke patients? METHODS A total of 21 patients with severe hemiplegic stroke were randomly assigned to the experimental and control groups. All participants (n = 21) received 60-minute sessions of general physical therapy, 5 times a week for a period of 12 weeks. Additionally, the experimental and control groups underwent underwater and overground walking training, respectively, for 30 min twice times a week for 12 weeks. Postural assessment for stroke score, center of pressure path length and velocity, step time and step length difference, and walking velocity were measured before and after the 12-week training. RESULTS Both groups showed a significant decrease in the center of pressure path length and velocity after the intervention compared to the values before the intervention (p < .05). However, there was no significant difference in the center of pressure path length and velocity changes after training between the two groups (p > .05). In the walking variables, the step length difference changes after training between the two groups showed a significant difference (p < .05). In the experimental group, the step length difference increased after the intervention compared to that before the intervention (+4.55 cm), whereas that of the control group decreased (-1.25 cm). SIGNIFICANCE In severe stroke patients, underwater gait training can be effective for improving balancing ability, but it may be less effective on the improvement of gait function than overground walking. CLINICAL TRIAL REGISTRATION NUMBER KCT0002587 (https://cris.nih.go.kr).",2020,"However, there was no significant difference in the center of pressure path length and velocity changes after training between the two groups (p > .05).","['21 patients with severe hemiplegic stroke', 'stroke patients', 'severe stroke patients', 'stroke patients with relatively severe disabilities', 'patients with severe hemiplegic stroke']","['Walking training', 'underwater gait training', '60-minute sessions of general physical therapy', 'underwater and overground walking training', 'underwater gait training and overground gait training', 'underwater gait training or overground gait training']","['center of pressure path length and velocity', 'Postural assessment for stroke score, center of pressure path length and velocity, step time and step length difference, and walking velocity', 'gait function', 'center of pressure path length and velocity changes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",21.0,0.0299419,"However, there was no significant difference in the center of pressure path length and velocity changes after training between the two groups (p > .05).","[{'ForeName': 'Nan-Hyang', 'Initials': 'NH', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, Graduate School of Daejeon University, Republic of Korea. Electronic address: kimnan1004@hanmail.net.'}, {'ForeName': 'Hoon-Young', 'Initials': 'HY', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, Graduate School of Daejeon University, Republic of Korea. Electronic address: phy9234@naver.com.'}, {'ForeName': 'Jin-Kyu', 'Initials': 'JK', 'LastName': 'Son', 'Affiliation': 'Department of Physical Therapy, College of Health and Medical Science, Daejeon University, Republic of Korea. Electronic address: thswlsrb1004@naver.com.'}, {'ForeName': 'Young', 'Initials': 'Y', 'LastName': 'Moon', 'Affiliation': 'Department of Physical Therapy, Graduate School of Daejeon University, Republic of Korea. Electronic address: moyo2ng@naver.com.'}, {'ForeName': 'Jun-Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medical Technology, College of Health and Medical Science, Daejeon University, Republic of Korea. Electronic address: jhlee@dju.kr.'}, {'ForeName': 'Yong-Jun', 'Initials': 'YJ', 'LastName': 'Cha', 'Affiliation': 'Department of Physical Therapy, College of Health and Medical Science, Daejeon University, Republic of Korea. Electronic address: cha0874@dju.kr.'}]",Gait & posture,['10.1016/j.gaitpost.2020.05.022'] 601,32506513,Use of metabolic syndrome severity to assess treatment with vitamin E and pioglitazone for non-alcoholic steatohepatitis.,"BACKGROUND AND AIM Non-alcoholic steatohepatitis (NASH), which can lead to liver failure, requires liver biopsies to follow and is difficult to treat. Our goal was to assess metabolic syndrome (MetS) severity as a predictor of treatment success and a marker of response. METHODS We assessed data from the Pioglitazone, Vitamin E, or Placebo for NASH Study, in which individuals with biopsy-confirmed NASH were randomized to receive pioglitazone, vitamin E, or placebo for 96 weeks. We assessed associations of a sex-specific and race/ethnicity-specific MetS severity Z-score (MetS-Z) at baseline and 48 weeks with biopsy-determined endpoint of NASH resolution at 96 weeks. RESULTS Baseline MetS-Z was inversely associated with odds of NASH resolution (odds ratio [OR] per 1 SD of MetS-Z: 0.47, 95% confidence interval [CI] 0.28, 0.79). Decrease in MetS-Z during initial 48-week intervention was greatest for pioglitazone treatment (effect size: -0.31, 95% CI -0.15, -0.48) and for vitamin E tended toward being greater for those with versus without NASH resolution (-0.18 vs -0.05). Overall, 48-week change in MetS-Z was associated with NASH resolution (OR per 1-SD change: 0.53, 95% CI 0.33, 0.85), although this was attenuated in models that included transaminases, which remained linked to treatment success (OR by change-in-aspartate aminotransferase Z-score: 0.38, 95% CI 0.19, 0.76). CONCLUSIONS Individuals with more severe metabolic derangement at baseline were less likely to exhibit NASH resolution, suggesting that individuals may have a threshold of MetS severity beyond which successful treatment is unlikely. As an integrated marker of metabolic abnormalities, MetS-Z was correlated with successful treatment, although transaminases were a more consistent marker of NASH resolution.",2021,"As an integrated marker of metabolic abnormalities, MetS-Z was correlated with successful treatment, though transaminases were a more consistent marker of NASH resolution.","['Non-alcoholic Steatohepatitis', 'individuals with biopsy-confirmed NASH']","['pioglitazone', 'Vitamin-E and Pioglitazone', 'pioglitazone, vitamin-E or placebo', 'Pioglitazone, Vitamin-E or Placebo NASH Study (PIVENS']","['NASH resolution', 'MetS-Z', 'metabolic syndrome (MetS) severity']","[{'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}]","[{'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.680429,"As an integrated marker of metabolic abnormalities, MetS-Z was correlated with successful treatment, though transaminases were a more consistent marker of NASH resolution.","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Gurka', 'Affiliation': 'Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Jasmine A', 'Initials': 'JA', 'LastName': 'Mack', 'Affiliation': 'Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Chi', 'Affiliation': 'Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'DeBoer', 'Affiliation': 'Department of Pediatrics, Division of Pediatric Endocrinology, University of Virginia, Charlottesville, Virginia, USA.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15131'] 602,32512513,The effects of repetitive transcranial magnetic stimulation on cue-induced craving in male patients with heroin use disorder.,"BACKGROUND Craving is a central feature of addiction. Early evidence suggests that repetitive transcranial magnetic stimulation is effective in reducing cue induced craving for patients with opioid use disorder (OUD). However, trials in large populations of patients with OUDs are lacking. METHODS We randomly assigned 118 male heroin patients into three groups (i.e., 10 Hz rTMS, 1 Hz rTMS and a wait-list control group) from two addiction rehabilitation centers. rTMS was applied to the left dorsolateral prefrontal cortex (DLPFC) for 20 daily consecutive sessions. FINDINGS Results showed that 10 Hz rTMS and 1 Hz rTMS were both effective in reducing cue-induced craving scores in heroin users when compared to the wait list group. The treatment effects lasted for up to 60 days after rTMS treatment cessation. INTERPRETATION Our results suggest that rTMS applied to the DLPFC is effective in reducing craving severity in heroin use disorder patients. Our results also suggest that such treatment effects can last for up to 60 days after treatment cessation.",2020,"FINDINGS Results showed that 10 Hz rTMS and 1 Hz rTMS were both effective in reducing cue-induced craving scores in heroin users when compared to the wait list group.","['male patients with heroin use disorder', '118 male heroin patients into three groups (i.e., 10', 'heroin use disorder patients', 'patients with opioid use disorder (OUD']","['repetitive transcranial magnetic stimulation', 'rTMS', 'Hz rTMS, 1\u202fHz rTMS and a wait-list control group) from two addiction rehabilitation centers']","['cue-induced craving scores', 'craving severity']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011892', 'cui_str': 'Heroin'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}]","[{'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",118.0,0.0241904,"FINDINGS Results showed that 10 Hz rTMS and 1 Hz rTMS were both effective in reducing cue-induced craving scores in heroin users when compared to the wait list group.","[{'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; School of Psychology, Nanjing Normal University, Nanjing, Jiangsu, China; Co-innovation Center of Neuroregeneration, Nantong University, Nantong, Jiangsu, China; Ningbo Key Laboratory of Sleep Medicine, Ningbo Kangning Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Xiwen', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Yale Center for Analytical Sciences, School of Public Health, Yale University, New Haven, CT, U.S.A.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; School of Psychology, Nanjing Normal University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Qingming', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; School of Psychology, Nanjing Normal University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, U.S.A.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, U.S.A.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Luo', 'Affiliation': 'Research Center of Brain and Cognitive Neuroscience, Liaoning Normal University, Dalian, China; Key Laboratory of Brain and Cognitive Neurosience, Liaoning Province, China. Electronic address: luowb@lnnu.edu.cn.'}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, University of Toronto, Toronto, Ont., Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Ti-Fei', 'Initials': 'TF', 'LastName': 'Yuan', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Co-innovation Center of Neuroregeneration, Nantong University, Nantong, Jiangsu, China. Electronic address: ytf0707@126.com.'}]",EBioMedicine,['10.1016/j.ebiom.2020.102809'] 603,32512517,Association between cellular HIV-1 DNA level and mortality in HIV-1 infected African adults starting ART with high CD4 counts.,"BACKGROUND High HIV-1 DNA levels in peripheral blood mononuclear cells (PBMC) were associated with a higher risk of severe morbidity and a faster decline in CD4 count in ART-naive patients. We report the association between HIV-1 DNA and mortality in HIV-infected adults in a trial of early ART in West Africa. METHODS In the Temprano trial, HIV-infected adults were randomly assigned to start ART immediately or defer ART. After trial termination, HIV-1 DNA was measured in whole blood samples frozen at baseline. We analyzed the association between baseline PBMC HIV-1 DNA and long-term mortality. FINDINGS 2019 patients were followed for 9253 patient-years (median 4.9 years). At baseline, the median CD4 count was 462/mm 3 [IQR 368-571], the median plasma HIV-1 RNA 4.7 log 10 copies/ml [IQR 4.0-5.2], and the median HIV-1 DNA 2.9 log 10 copies/million PBMC [IQR 2.5-3.3]. During follow-up, 86 participants died. In univariate analysis, the hazard ratio [HR] of death was 2.67 (95% CI, 1.68-4.22) for patients with HIV-1 DNA ≥3 log 10 copies/million PBMC vs. others, and 2.10 (95% CI, 1.38-3.21) for patients with HIV-1 RNA ≥5 log10 copies/ml vs. others. In multivariate Cox regression analysis, HIV-1 DNA levels ≥3 log 10 copies/million PBMC were strongly associated mortality (adjusted HR = 2.09, 95% CI 1.24-3.52, p= 0.005) while the association between baseline plasma HIV-1 RNA and mortality was not significant. INTERPRETATION In these African adults who started ART with high CD4 counts, HIV-1 DNA was a strong independent predictor of death. The HIV reservoir still plays a prognostic role in the early ART era. FUNDING This trial was supported by the French National Agency for AIDS and viral hepatitis research (ANRS, Paris, France; Grants ANRS 12136, 12224 and 12253).",2020,"At baseline, the median CD4 count was 462/mm 3 [IQR 368-571], the median plasma HIV-1 RNA 4.7 log 10 copies/ml [IQR 4.0-5.2], and the median HIV-1 DNA 2.9 log 10 copies/million PBMC [IQR 2.5-3.3].","['HIV-infected adults in a trial of early ART in West Africa', '2019 patients were followed for 9253 patient-years (median 4.9 years', 'HIV-infected adults', 'HIV-1 infected African adults starting ART with high CD4 counts']",[],"['median plasma HIV-1 RNA', 'hazard ratio [HR] of death', 'HIV-1 DNA and mortality', 'HIV-1 DNA', 'mortality', 'median CD4 count', 'baseline plasma HIV-1 RNA and mortality', 'CD4 count']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0001747', 'cui_str': 'Western Africa'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}]",[],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0486948', 'cui_str': 'Human immunodeficiency virus 1 DNA'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",2019.0,0.300537,"At baseline, the median CD4 count was 462/mm 3 [IQR 368-571], the median plasma HIV-1 RNA 4.7 log 10 copies/ml [IQR 4.0-5.2], and the median HIV-1 DNA 2.9 log 10 copies/million PBMC [IQR 2.5-3.3].","[{'ForeName': 'Jean Baptiste', 'Initials': 'JB', 'LastName': ""N'takpe"", 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire. Electronic address: jean-baptiste.ntakpe@u-bordeaux.fr.""}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Gabillard', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': 'Raoul', 'Initials': 'R', 'LastName': 'Moh', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; Département de Dermatologie et Maladies Infectieuses, Université Felix Houphouët Boigny, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Gardiennet', 'Affiliation': 'AP-HP, CHU Necker Enfants Malades, EA 7327 Université Paris Descartes, Paris, France.'}, {'ForeName': 'Arlette', 'Initials': 'A', 'LastName': 'Emieme', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; CeDReS, CHU de Treichville, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Anani', 'Initials': 'A', 'LastName': 'Badje', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': 'Gérard M', 'Initials': 'GM', 'LastName': 'Kouame', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': ""Thomas-d'Aquin"", 'Initials': 'TD', 'LastName': 'Toni', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; CeDReS, CHU de Treichville, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Karcher', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': 'Jérome Le', 'Initials': 'JL', 'LastName': 'Carrou', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Ménan', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; CeDReS, CHU de Treichville, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Danel', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': 'Serge P', 'Initials': 'SP', 'LastName': 'Eholie', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; Département de Dermatologie et Maladies Infectieuses, Université Felix Houphouët Boigny, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Rouzioux', 'Affiliation': ""PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; AP-HP, CHU Necker Enfants Malades, EA 7327 Université Paris Descartes, Paris, France.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Anglaret', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}]",EBioMedicine,['10.1016/j.ebiom.2020.102815'] 604,32523035,Who's a good boy? Effects of dog and owner body weight on veterinarian perceptions and treatment recommendations.,"BACKGROUND Weight bias against persons with obesity impairs health care delivery and utilization and contributes to poorer health outcomes. Despite rising rates of pet obesity (including among dogs), the potential for weight bias in veterinary settings has not been examined. SUBJECTS/METHODS In two online, 2 × 2 experimental studies, the effects of dog and owner body weight on perceptions and treatment recommendations were investigated in 205 practicing veterinarians (Study 1) and 103 veterinary students (Study 2). In both studies, participants were randomly assigned to view one of four vignettes of a dog and owners with varying weight statuses (lean vs. obesity). Dependent measures included emotion/liking ratings toward the dog and owners; perceived causes of the dog's weight; and treatment recommendations and compliance expectations. Other clinical practices, such as terms to describe excess weight in dogs, were also assessed. RESULTS Veterinarians and students both reported feeling more blame, frustration, and disgust toward dogs with obesity and their owners than toward lean dogs and their owners (p values < 0.001). Interactions between dog and owner body weight emerged for perceived causes of obesity, such that owners with obesity were perceived as causing the dog with obesity's weight, while lean owners were perceived as causing the lean dog's weight. Participants were pessimistic about treatment compliance from owners of the dog with obesity, and weight loss treatment was recommended for the dog with obesity when presenting with a medical condition ambiguous in its relationship to weight. Veterinarians and students also reported use of stigmatizing terms to describe excess weight in dogs. CONCLUSIONS Findings from this investigation, with replication, have implications for training and practice guidelines in veterinary medicine.",2020,"In two online, 2 × 2 experimental studies, the effects of dog and owner body weight on perceptions and treatment recommendations were investigated in 205 practicing veterinarians (Study 1) and 103 veterinary students (Study 2).",['205 practicing veterinarians (Study 1) and 103 veterinary students (Study 2'],[],"[""emotion/liking ratings toward the dog and owners; perceived causes of the dog's weight; and treatment recommendations and compliance expectations""]","[{'cui': 'C0242856', 'cui_str': 'Veterinarian'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0042614', 'cui_str': 'veterinary'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",[],"[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0012984', 'cui_str': 'Canis lupus familiaris'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}]",205.0,0.0204946,"In two online, 2 × 2 experimental studies, the effects of dog and owner body weight on perceptions and treatment recommendations were investigated in 205 practicing veterinarians (Study 1) and 103 veterinary students (Study 2).","[{'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Pearl', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. rpearl@pennmedicine.upenn.edu.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Bach', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Leonard', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Michel', 'Affiliation': 'Department of Clinical Sciences and Advanced Medicine, University of Pennsylvania School of Veterinary Medicine, Philadelphia, PA, USA.'}]",International journal of obesity (2005),['10.1038/s41366-020-0622-7'] 605,32525222,Effects of bilateral transcranial direct current stimulation on working memory and global cognition in older patients with remitted major depression: A pilot randomized clinical trial.,"OBJECTIVES To assess the effects of a 10-day course of bilateral anodal transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC) on working memory and global cognition in elderly participants with remitted major depressive disorder at 14 days (primary outcome) and 90 days (secondary outcome) post intervention. DESIGN Randomized double blind controlled trial (clinicaltrials.gov # NCT02212366). SETTING Community dwelling outpatient setting. PARTICIPANTS Sixty or older with previous single or recurrent episodes of major depression currently in full remission. INTERVENTION A 10 day course of active or sham bilateral DLPFC anodal tDCS. MEASUREMENTS (a) Working memory assessed by a computerized N back task, and (b) global cognition assessed by a standard paper and pencil neuropsychological test battery. RESULTS Thirty-three participants, (mean (SD) age = 66. 5 (5.7) year) were enrolled, out of which 18 (mean (SD) age = 66. 3 (5.8) year) were randomized to active tDCS and 15 (mean (SD) age = 66. 7 (5.8) years) to sham tDCS. All randomized participants except one from the sham group -completed the tDCS course. There were no differences between the groups on working memory performance or global cognition at 14 or 90 days post intervention. Both groups showed promising changes in working memory and global cognition over time. CONCLUSIONS tDCS was well tolerated in older patients with remitted MDD, however, as compared to the sham group, it did not improve working memory or global cognition. Future studies should investigate tDCS with alternative parameters to enhance cognition in this population.",2020,There were no differences between the groups on working memory performance or global cognition at 14 or 90 days post intervention.,"['elderly participants with remitted major depressive disorder at 14\u2009days (primary outcome) and 90\u2009days (secondary outcome) post intervention', 'Thirty-three participants, (mean (SD) age\xa0', 'Community dwelling outpatient setting', 'older patients with remitted MDD', '60 or older with previous single or recurrent episodes of major depression currently in full remission', 'Older Patients with Remitted Major Depression', '5 (5.7) year) were enrolled, out of which 18 (mean (SD) age\xa0=\xa066']","['Bilateral Transcranial Direct Current Stimulation', 'active or sham bilateral DLPFC anodal tDCS', 'tDCS', 'bilateral anodal transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC', 'active tDCS']","['working memory performance or global cognition', 'working memory or global cognition', '1) working memory assessed by a computerized N back task, and 2) global cognition assessed by a standard paper and pencil neuropsychological test battery', 'Working Memory and Global Cognition', 'working memory and global cognition']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1269683', 'cui_str': 'Major depressive disorder'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0154409', 'cui_str': 'Recurrent major depressive episodes'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0441059', 'cui_str': 'Pencil'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}]",,0.222182,There were no differences between the groups on working memory performance or global cognition at 14 or 90 days post intervention.,"[{'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Geriatric Psychiatry Division, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Judah', 'Initials': 'J', 'LastName': 'Batist', 'Affiliation': 'Geriatric Psychiatry Division, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Zaid', 'Initials': 'Z', 'LastName': 'Ghazala', 'Affiliation': 'Geriatric Psychiatry Division, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Reza M', 'Initials': 'RM', 'LastName': 'Zomorrodi', 'Affiliation': 'Geriatric Psychiatry Division, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Brooks', 'Affiliation': 'Geriatric Psychiatry Division, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Goodman', 'Affiliation': 'Geriatric Psychiatry Division, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Geriatric Psychiatry Division, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Geriatric Psychiatry Division, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Geriatric Psychiatry Division, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Tarek K', 'Initials': 'TK', 'LastName': 'Rajji', 'Affiliation': 'Geriatric Psychiatry Division, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}]",International journal of geriatric psychiatry,['10.1002/gps.5361'] 606,32531302,Wound eversion versus planar closure for wounds on the face or neck: A randomized split-wound comparative effectiveness trial.,,2020,,['Wounds on the Face or Neck'],['Wound Eversion Versus Planar Closure'],[],"[{'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}]","[{'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0015211', 'cui_str': 'Eversion'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]",[],,0.024742,,"[{'ForeName': 'Claire C', 'Initials': 'CC', 'LastName': 'Alexanian', 'Affiliation': 'Department of Dermatology, University of California, Davis, Sacramento, California; Georgetown University School of Medicine, Washington, DC.'}, {'ForeName': 'Anne R', 'Initials': 'AR', 'LastName': 'Zhuang', 'Affiliation': 'Department of Dermatology, University of California, Davis, Sacramento, California.'}, {'ForeName': 'Milene K', 'Initials': 'MK', 'LastName': 'Crispin', 'Affiliation': 'Department of Dermatology, University of California, Davis, Sacramento, California.'}, {'ForeName': 'April W', 'Initials': 'AW', 'LastName': 'Armstrong', 'Affiliation': 'Department of Dermatology, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Eisen', 'Affiliation': 'Department of Dermatology, University of California, Davis, Sacramento, California. Electronic address: deisen123@gmail.com.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.06.013'] 607,32540337,Consolidation cetuximab after concurrent triplet radiochemotherapy+cetuximab in patients with advanced head and neck cancer: A randomized phase II study.,"BACKGROUND AND PURPOSE Preclinical data suggest that cetuximab should be continued after end of concurrent radiotherapy+cetuximab due to its efficacy against residual tumor cells in the irradiated tumor bed. Based on this concept the phase II add-on cetuximab (AOC) study was designed. MATERIALS AND METHODS Altogether 63 patients with advanced head and neck cancer were treated with radiochemotherapy (70 Gy, cisplatin 40 mg/m 2 weekly) in combination with concurrent cetuximab (loading dose 400 mg/m 2 , then 250 mg/m 2 weekly). Thereafter patients were randomized to cetuximab consolidation (500 mg/m 2 biweekly × 6) or no further treatment. The primary endpoint was the 2-year locoregional control (LRC) rate. As translational research endpoints serum markers were analyzed before and during treatment and CT-based quantitative image analysis (radiomics) was performed. RESULTS Median follow-up was 24 months. The 2-year LRC rates were 67.9% and 67.7% in the treatment arms with and without consolidation cetuximab, respectively. Higher than median levels of three serum markers were negatively associated with the 2-year LRC rate in the overall patient cohort: Osteopontin, IL8 and FasL2 (p ≤ 0.05). A radiomics model consisting of two radiomics features could be built showing that higher entropy and higher complexity of tumor Hounsfield unit distribution indicates worse LRC (concordance index 0.66). No correlation was found between biological and imaging markers. CONCLUSIONS There was no evidence that consolidation cetuximab would improve the 2-year LRC rate. Prognostic biological and imaging markers could be identified for the overall patient cohort. Studies with larger patient numbers are needed to correlate biological and imaging markers.",2020,"Higher than median levels of three serum markers were negatively associated with the 2-year LRC rate in the overall patient cohort: Osteopontin, IL8 and FasL2 (p≤0.05).","['Altogether 63 patients with advanced head and neck cancer', 'patients with advanced head and neck cancer']","['radiochemotherapy + cetuximab', 'radiochemotherapy (70 Gy, cisplatin 40mg/m2 weekly) in combination with concurrent cetuximab', 'Consolidation cetuximab', 'radiotherapy + cetuximab', 'cetuximab consolidation']","['2-year LRC rates', '2-year LRC rate', '2-year locoregional control (LRC) rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}]","[{'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",63.0,0.0261113,"Higher than median levels of three serum markers were negatively associated with the 2-year LRC rate in the overall patient cohort: Osteopontin, IL8 and FasL2 (p≤0.05).","[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Riesterer', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland; Center for Radiation Oncology KSA-KSB, Cantonal Hospital Aarau, Switzerland. Electronic address: oliver.riesterer@ksa.ch.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Pruschy', 'Affiliation': 'Laboratory for Molecular Radiobiology, University of Zurich, Switzerland.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Bender', 'Affiliation': 'Laboratory for Molecular Radiobiology, University of Zurich, Switzerland.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Laboratory for Molecular Radiobiology, University of Zurich, Switzerland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Bogowicz', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Tanadini-Lang', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Stieb', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Kaja', 'Initials': 'K', 'LastName': 'Bertogg', 'Affiliation': 'Clinical Trials Center, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Weber', 'Affiliation': 'Clinical Trials Center, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Ikenberg', 'Affiliation': 'Institute of Pathology and Molecular Pathology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Huber', 'Affiliation': 'Department of Otorhinolaryngology, University Hospital Zurich, University of Zurich, Switzerland; Department of Otorhinolaryngology, Cantonal Hospital St. Gallen, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Schmid', 'Affiliation': 'Otorhinolaryngology Clinic Bethanien, Zurich, Switzerland.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Bredell', 'Affiliation': 'Clinic for Oral and Maxillofacial Surgery, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Veit-Haibach', 'Affiliation': 'Department of Nuclear Medicine, University Hospital Zurich, Switzerland; Department of Diagnostic and Interventional Radiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Rordorf', 'Affiliation': 'Department of Medical Oncology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Held', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, Department of Biostatistics, University of Zurich, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Glanzmann', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland; Department of Radiation Oncology, Cantonal Hospital Lucerne, Switzerland.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Studer', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland; Department of Radiation Oncology, Cantonal Hospital Lucerne, Switzerland.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.06.011'] 608,32542879,The Adjunctive Effect of Intravenous Magnesium Sulfate in Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Randomized Controlled Clinical Trial.,,2021,It relaxes bronchial smooth muscles through its calcium channel blocking properties and inhibitory effects on the release of acetylcholine from neuromuscular junctions.,"['Chronic Obstructive Pulmonary Disease (COPD', 'Acute Exacerbation of COPD']","['Magnesium', 'Intravenous Magnesium Sulfate', 'Intravenous (IV) magnesium sulfate (MgS04']",['Acute exacerbation of COPD (AECOPD'],"[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}]","[{'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}]",,0.0879475,It relaxes bronchial smooth muscles through its calcium channel blocking properties and inhibitory effects on the release of acetylcholine from neuromuscular junctions.,"[{'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Vafadar Moradi', 'Affiliation': 'From the, Faculty of Medicine, Emam Reza Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Pishbin', 'Affiliation': 'From the, Faculty of Medicine, Emam Reza Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Seyed Reza', 'Initials': 'SR', 'LastName': 'Habibzadeh', 'Affiliation': 'From the, Faculty of Medicine, Emam Reza Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Talebi Doluee', 'Affiliation': 'From the, Faculty of Medicine, Emam Reza Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Soltanifar', 'Affiliation': 'and the, Faculty of Medicine, Tehran University of Medical Sciences, Tahran, Iran.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14050'] 609,32546211,Effect of hypothermic perfusion on phacoemulsification in cataract patients complicated with uveitis: a randomised trial.,"BACKGROUND To evaluate the effectiveness and safety of hypothermic perfusion in the phacoemulsification of cataract caused by uveitis. METHODS This was a prospective, single-masked, randomised, controlled clinical trial. One hundred and six patients with uveitis-associated cataract underwent phacoemulsification with perfusion fluid temperature at 4 °C (treatment group) or 24 °C (control group). Anterior chamber inflammation grade, corneal endothelial cell count, corneal thickness, macular fovea thickness, and intraocular pressure (IOP) were observed on the 1st day and 7th day after operation. RESULTS The aqueous flare score was 0.83 ± 0.76 in the 4 °C group, which was lower than that in the 24 °C group (1.51 ± 1.02, p = 0.006) on the first day after operation. The aqueous cells score was lower in the 4 °C group (0.17 ± 0.38) than that in the 24 °C group (0.62 ± 0.94, p = 0.025). The mean corneal thickness of incision in the 4 °C group (907.66 ± 85.37 μm) was thinner than that in the 24 °C group (963.75 ± 103.81 μm, p = 0.005). Corneal endothelial cells density, macular fovea thickness, or percentage of transiently increased IOP showed no difference between the two groups (p > 0.05). There was no significant difference in all the main outcome parameters between the two groups on the 7th day after operation (p > 0.05). CONCLUSIONS Hypothermic perfusion in the phacoemulsification of uveitis-associated cataract is safe, and it can effectively inhibit anterior chamber inflammation and reduce the incisional corneal edema in the early postoperative stage. TRIAL REGISTRATION The study was registered with the Chinese Clinical Trial Registry. (http://www.chictr.org.cn/, Registration Number: ChiCTR1800016145).",2020,"Corneal endothelial cells density, macular fovea thickness, or percentage of transiently increased IOP showed no difference between the two groups (p > 0.05).","['One hundred and six patients with uveitis-associated cataract underwent', 'cataract patients complicated with uveitis']","['phacoemulsification with perfusion fluid temperature', 'hypothermic perfusion']","['aqueous cells score', 'mean corneal thickness of incision', 'incisional corneal edema', 'Anterior chamber inflammation grade, corneal endothelial cell count, corneal thickness, macular fovea thickness, and intraocular pressure (IOP', 'aqueous flare score', 'Corneal endothelial cells density, macular fovea thickness, or percentage of transiently increased IOP']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}]","[{'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}]","[{'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0429493', 'cui_str': 'Corneal thickness'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0010037', 'cui_str': 'Corneal edema'}, {'cui': 'C1096278', 'cui_str': 'Anterior chamber inflammation'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0016622', 'cui_str': 'Structure of fovea centralis'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0423281', 'cui_str': 'Anterior chamber flare'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0234708', 'cui_str': 'Raised intraocular pressure'}]",106.0,0.0548939,"Corneal endothelial cells density, macular fovea thickness, or percentage of transiently increased IOP showed no difference between the two groups (p > 0.05).","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Wenjuan', 'Initials': 'W', 'LastName': 'Wan', 'Affiliation': 'The First Affiliated Hospital of Chongqing Medical University, Chongqing Key Laboratory of Ophthalmology and Chongqing Eye Institute, Chongqing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xun', 'Affiliation': 'Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Xiong', 'Affiliation': 'Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Binge', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'The Second affiliated hospital of Baotou medical college, Baotou, Inner Mongolia Autonomous Region, China.'}, {'ForeName': 'Yongguo', 'Initials': 'Y', 'LastName': 'Xiang', 'Affiliation': 'Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Zhouyu', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ji', 'Affiliation': 'The First Affiliated Hospital of Chongqing Medical University, Chongqing Key Laboratory of Ophthalmology and Chongqing Eye Institute, Chongqing, China.'}, {'ForeName': 'Peizeng', 'Initials': 'P', 'LastName': 'Yang', 'Affiliation': 'The First Affiliated Hospital of Chongqing Medical University, Chongqing Key Laboratory of Ophthalmology and Chongqing Eye Institute, Chongqing, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Hu', 'Affiliation': 'Chongqing Medical University, Chongqing, China. 42222@qq.com.'}]",BMC ophthalmology,['10.1186/s12886-020-01507-9'] 610,32557384,The Influence of Laparoscopic Sleeve Gastrectomy on Body Composition and Fat Distribution in Obese Caucasian Men and Women.,"BACKGROUND The aim of the study was to assess changes in body composition in patients subjected to laparoscopic sleeve gastrectomy (LSG). METHODS Changes in body composition following LSG were determined in a group of 155 patients with obesity (117 women and 38 men), with dual-energy X-ray absorptiometry (DXA). Whole body fat mass (FM) and lean body mass (LBM) were determined, and abdominal fat mass (AbdF) was assessed within the region extending from the top of the pubic bone up to the line between 12th thoracic and 1st lumbar vertebras. RESULTS Over the period of 12 months following LSG, body mass index decreased by 28.2 ± 9.0% (p < 0.001). The reduction of body weight by 35.4 ± 12.6 kg (p < 0.001) was the result of a decrease in FM by 23.9 ± 8.9 kg (p < 0.001) and LBM by 10.5 ± 3.8 kg (p < 0.001). AbdF decreased from 13.2 ± 3.1 to 8.2 ± 2.7 kg (p < 0.001), but abdominal fat to total fat mass ratio increased from 24.9 ± 4.7 to 28.0 ± 5.8% (p < 0.001). The loss of AbdF was more pronounced in men than in women. The rate of FM loss was attenuated with patients' age. CONCLUSIONS Over the period of 12 months following LSG, the reduction of FM was more than twice as much as decrease of LBM. The loss of AbdF was slower than a loss of peripheral subcutaneous fat.",2020,The reduction of body weight by 35.4 ± 12.6 kg (p < 0.001) was the result of a decrease in FM by 23.9 ± 8.9 kg (p < 0.001) and LBM by 10.5 ± 3.8 kg (p < 0.001).,"['patients subjected to', '155 patients with obesity (117 women and 38 men), with dual-energy X-ray absorptiometry (DXA', 'Obese Caucasian Men and Women']","['Laparoscopic Sleeve Gastrectomy', 'laparoscopic sleeve gastrectomy (LSG']","['rate of FM loss', 'FM', 'body mass index', 'reduction of body weight', 'body composition', 'abdominal fat to total fat mass ratio', 'LBM', 'loss of AbdF', 'Body Composition and Fat Distribution', 'Whole body fat mass (FM) and lean body mass (LBM', 'reduction of FM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1563742', 'cui_str': 'Fat, Abdominal'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1264679', 'cui_str': 'Mass ratio'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}]",155.0,0.0416692,The reduction of body weight by 35.4 ± 12.6 kg (p < 0.001) was the result of a decrease in FM by 23.9 ± 8.9 kg (p < 0.001) and LBM by 10.5 ± 3.8 kg (p < 0.001).,"[{'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Tałałaj', 'Affiliation': 'Department of Geriatrics, Internal Medicine and Metabolic Bone Diseases, Centre of Postgraduate Medical Education, Orłowski Hospital, Czerniakowska 231, 00-416, Warsaw, Poland. marektalalaj@op.pl.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Bogołowska-Stieblich', 'Affiliation': 'Department of Geriatrics, Internal Medicine and Metabolic Bone Diseases, Centre of Postgraduate Medical Education, Orłowski Hospital, Czerniakowska 231, 00-416, Warsaw, Poland.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Wąsowski', 'Affiliation': 'Department of Geriatrics, Internal Medicine and Metabolic Bone Diseases, Centre of Postgraduate Medical Education, Orłowski Hospital, Czerniakowska 231, 00-416, Warsaw, Poland.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Binda', 'Affiliation': 'Department of General, Oncological and Digestive Tract Surgery, Centre of Postgraduate Medical Education, Orłowski Hospital, Czerniakowska 231, 00-416, Warsaw, Poland.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Jaworski', 'Affiliation': 'Department of General, Oncological and Digestive Tract Surgery, Centre of Postgraduate Medical Education, Orłowski Hospital, Czerniakowska 231, 00-416, Warsaw, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Wrzosek', 'Affiliation': 'Department of Biochemistry and Pharmacogenomics, Faculty of Pharmacy, Medical University of Warsaw, Banacha 1, 02-097, Warsaw, Poland.'}, {'ForeName': 'Wiesław', 'Initials': 'W', 'LastName': 'Tarnowski', 'Affiliation': 'Department of General, Oncological and Digestive Tract Surgery, Centre of Postgraduate Medical Education, Orłowski Hospital, Czerniakowska 231, 00-416, Warsaw, Poland.'}]",Obesity surgery,['10.1007/s11695-020-04766-z'] 611,32553881,Efficacy and safety of weekly rifapentine and isoniazid for tuberculosis prevention in Chinese silicosis patients: a randomized controlled trial.,"OBJECTIVE The aim was to evaluate the efficacy, safety and completion rate of 3-month, once-weekly rifapentine and isoniazid for tuberculosis (TB) prevention among Chinese silicosis patients. METHODS Male silicosis patients without human immunodeficiency virus infection, aged 18 years to 65 years, with or without latent TB infection, were randomized 1:1 to receive rifapentine/isoniazid under direct observation (3RPT/INH group) or were untreated (observation group). Active TB incidence was compared between the two groups with 37 months of follow-up. Safety profile and complete rates were evaluated. RESULTS A total of 1227 adults with silicosis were screened; 513 eligible participants were enrolled and assigned to 3RPT/INH (n = 254) vs. observation (n = 259). Twenty-eight participants were diagnosed with active TB, and 9 and 19 in the 3RPT/INH group and observation groups, respectively. In the intention-to-treat analysis, the cumulative active TB rate was 3.5% (9/254) in the 3RPT/INH group and 7.3% (19/259) in the observation group (log rank p 0.055). On per protocol analysis, the cumulative active TB rates were 0.7% (1/139) and 7.3% (19/259), respectively (log rank p 0.01). Owing to an unexpected high frequency of adverse events (70.4%) and Grade 3 or 4 AEs (7.9%), the completion rate of the 3RPT/INH regimen was 54.7% (139/254). Twenty-six (10.8%) participants had flu-like systemic drug reactions; five (2.1%) experienced hepatotoxicity. DISCUSSION Weekly rifapentine/isoniazid prophylaxis prevented active TB among Chinese people with silicosis when taken, irrespective of LTBI screening; efficacy was reduced by lack of compliance. The regimen must be used with caution because of the high rates of adverse effects. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov number: NCT02430259.",2021,"Twenty-six (10.8%) participants had flu-like systemic drug reactions; five (2.1%) experienced hepatotoxicity. ","['Chinese silicosis patients', 'Twenty-eight participants were diagnosed with active TB, 9 and 19 in the 3RPT/INH group and observation groups, respectively', 'Male silicosis patients without human immunodeficiency virus infection, aged 18\xa0years to 65\xa0years, with or without latent TB infection', 'n=254) vs observation (n=259', '1,227 adults with silicosis were screened; 513 eligible participants']","['3RPT/INH', 'rifapentine/isoniazid under direct observation (3RPT/INH group) or were untreated (observation group', 'rifapentine and isoniazid', 'rifapentine/isoniazid prophylaxis']","['Active TB incidence', 'completion rate', 'Safety profile and complete rates', 'Efficacy and safety', 'efficacy, safety and completion rate', 'flu-like systemic drug reactions', 'cumulative active TB rate', 'adverse events', 'cumulative active TB rates', 'active TB', 'hepatotoxicity']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0037116', 'cui_str': 'Pneumoconiosis due to silica'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1609538', 'cui_str': 'Inactive tuberculosis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0073372', 'cui_str': 'rifapentine'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}]",1227.0,0.444171,"Twenty-six (10.8%) participants had flu-like systemic drug reactions; five (2.1%) experienced hepatotoxicity. ","[{'ForeName': 'Qiao-Ling', 'Initials': 'QL', 'LastName': 'Ruan', 'Affiliation': 'Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai 200040, China; National Clinical Research Centre for Aging and Medicine, Huashan Hospital, Fudan University, Shanghai 200040, China.'}, {'ForeName': 'Xi-Tian', 'Initials': 'XT', 'LastName': 'Huang', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Qing-Luan', 'Initials': 'QL', 'LastName': 'Yang', 'Affiliation': 'Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai 200040, China.'}, {'ForeName': 'Xue-Feng', 'Initials': 'XF', 'LastName': 'Liu', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai 200040, China; National Clinical Research Centre for Aging and Medicine, Huashan Hospital, Fudan University, Shanghai 200040, China.'}, {'ForeName': 'Ke-Chuan', 'Initials': 'KC', 'LastName': 'Pan', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Yao-Jie', 'Initials': 'YJ', 'LastName': 'Shen', 'Affiliation': 'Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai 200040, China; State Key Laboratory of Genetic Engineering, School of Life Science, Fudan University, Shanghai 200438, China.'}, {'ForeName': 'Li-Min', 'Initials': 'LM', 'LastName': 'Cai', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Ling', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Jin-Jing', 'Initials': 'JJ', 'LastName': 'Hong', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Xiao-Dan', 'Initials': 'XD', 'LastName': 'Wang', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Chun-Lian', 'Initials': 'CL', 'LastName': 'Ma', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Guan-Qing', 'Initials': 'GQ', 'LastName': 'Peng', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Xiu-Zhen', 'Initials': 'XZ', 'LastName': 'Wang', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Jin-Chao', 'Initials': 'JC', 'LastName': 'Mao', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Tian-Zhou', 'Initials': 'TZ', 'LastName': 'Wu', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Miao-Yao', 'Initials': 'MY', 'LastName': 'Lin', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Ling-Yun', 'Initials': 'LY', 'LastName': 'Shao', 'Affiliation': 'Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai 200040, China; National Clinical Research Centre for Aging and Medicine, Huashan Hospital, Fudan University, Shanghai 200040, China. Electronic address: lingyun26@fudan.edu.cn.'}, {'ForeName': 'Wen-Hong', 'Initials': 'WH', 'LastName': 'Zhang', 'Affiliation': 'Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai 200040, China; National Clinical Research Centre for Aging and Medicine, Huashan Hospital, Fudan University, Shanghai 200040, China; Key Laboratory of Medical Molecular Virology (MOE/MOH) and Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, Shanghai 200032, China; State Key Laboratory of Genetic Engineering, School of Life Science, Fudan University, Shanghai 200438, China. Electronic address: zhangwenhong@fudan.edu.cn.'}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2020.06.008'] 612,32560970,Development of children born from freeze-only versus fresh embryo transfer: follow-up of a randomized controlled trial.,"OBJECTIVE To compare the longer-term development outcomes in children born after freeze-only versus fresh embryo transfer (ET) in women with an ovulatory cycle. DESIGN Long-term follow-up study (NCT04099784) of babies born alive after the first ET in a randomized controlled trial (RCT) comparing ongoing pregnancy and live birth rates after use of a freeze-only versus fresh ET strategy (NCT02471573). SETTING Private clinic. PATIENT(S) Of 391 couples randomized to each treatment group in the RCT, 132 (97 singleton/35 twins) and 123 (95 singleton/28 twins) in the freeze-only and fresh ET groups had live birth; 113 parents (86%) from the freeze-only group (147 babies) and 99 (80%) from the fresh ET group (120 babies) returned questionnaires for this follow-up study. INTERVENTION(S) Use of a freeze-only or fresh ET strategy after controlled ovarian hyperstimulation with a follicle-stimulating hormone/gonadotropin-releasing antagonist protocol. MAIN OUTCOME MEASURE(S) Developmental status at ≥2 years after birth, determined using the Developmental Red Flags and Ages & Stages Third Edition (ASQ-3) Questionnaires. RESULT(S) Mean age of children at the end of follow-up was 37 months. Height (95.0 ± 6.1 vs. 95.7 ± 5.6 cm) and weight (14.9 ± 2.6 vs. 14.8 ± 2.6 kg) were similar in the freeze-only and fresh ET groups (results were similar when singletons and twins were analyzed separately). Overall, ASQ-3 scores for problem solving were significantly better in the freeze-only versus fresh ET group (overall: 53.6 ± 8.4 vs. 51.1 ± 10.2), with no significant between-group difference when singletons (52.3 ± 10.1 vs. 51.0 ± 9.9) and twins (55.0 ± 5.5 vs. 51.4 ± 11.1) were analyzed separately. Fine motor skills scores were numerically higher (with P values approaching statistical significance) in the freeze-only versus fresh ET group in the overall analysis (47.8 ± 11.6 vs. 44.9 ± 12.6) and twins (49.85 ± 8.72 vs. 43.93 ± 12.71), but not singletons (46.0 ± 13.4 vs. 45.4 ± 12.6). The overall proportion of children with abnormal ASQ-3 (6.8% vs. 8.3%) or abnormal Red Flags (5.4% vs. 6.7%) findings in the freeze-only and fresh ET groups was low and did not differ significantly between groups. CONCLUSION(S) These data provide physicians with additional information on which to base decisions about the relative merits of different approaches to infertility treatment. There do not appear to be any grounds for concern about worse outcomes after use of a freeze-only strategy. However, additional studies comparing childhood development after a freeze-only strategy, fresh ET, and natural cycles are needed before firm conclusions can be drawn.",2020,"Fine motor skills scores were numerically higher (with P values approaching statistical significance) in the freeze-only versus fresh ET group in the overall analysis (47.8 ± 11.6 vs. 44.9 ± 12.6) and twins (49.85 ± 8.72 vs. 43.93 ± 12.71), but not singletons (46.0 ± 13.4 vs. 45.4 ± 12.6).","['children born after', 'women with an ovulatory cycle', 'children born from', '132 (97 singleton/35 twins) and 123 (95 singleton/28 twins) in the freeze-only and fresh ET groups had live birth; 113 parents (86%) from the freeze-only group (147 babies) and 99 (80%) from the fresh ET group (120 babies) returned questionnaires for this follow-up study', '391 couples randomized to each treatment group in the RCT', 'Private clinic', 'babies born alive after the first ET']","['freeze-only or fresh ET strategy', 'freeze-only versus fresh embryo transfer (ET', 'freeze-only versus fresh embryo transfer']","['Developmental Red Flags and Ages & Stages Third Edition (ASQ-3) Questionnaires', 'Fine motor skills scores', 'overall proportion of children with abnormal ASQ-3', 'abnormal Red Flags', 'Overall, ASQ-3 scores for problem solving']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory'}, {'cui': 'C0041427', 'cui_str': 'Twin sibling'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0440732', 'cui_str': 'Fresh embryo'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}]","[{'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0440732', 'cui_str': 'Fresh embryo'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}]","[{'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C5200790', 'cui_str': 'Flags'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0441796', 'cui_str': 'Third edition'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}]",391.0,0.0738169,"Fine motor skills scores were numerically higher (with P values approaching statistical significance) in the freeze-only versus fresh ET group in the overall analysis (47.8 ± 11.6 vs. 44.9 ± 12.6) and twins (49.85 ± 8.72 vs. 43.93 ± 12.71), but not singletons (46.0 ± 13.4 vs. 45.4 ± 12.6).","[{'ForeName': 'Lan Ngoc', 'Initials': 'LN', 'LastName': 'Vuong', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam; IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam; HOPE Research Center, My Duc Hospital, Ho Chi Minh City, Vietnam. Electronic address: lanvuong@ump.edu.vn.'}, {'ForeName': 'Trung Thien', 'Initials': 'TT', 'LastName': 'Ly', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nghia An', 'Initials': 'NA', 'LastName': 'Nguyen', 'Affiliation': 'Department of Pediatrics, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Loc Minh Tai', 'Initials': 'LMT', 'LastName': 'Nguyen', 'Affiliation': 'HOPE Research Center, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Xuyen Thi Ha', 'Initials': 'XTH', 'LastName': 'Le', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Tien Khac', 'Initials': 'TK', 'LastName': 'Le', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Khanh Tuan Quoc', 'Initials': 'KTQ', 'LastName': 'Le', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Thanh Van', 'Initials': 'TV', 'LastName': 'Le', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Minh Hoang Nhat', 'Initials': 'MHN', 'LastName': 'Nguyen', 'Affiliation': 'HOPE Research Center, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Vinh Quang', 'Initials': 'VQ', 'LastName': 'Dang', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam; HOPE Research Center, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Norman', 'Affiliation': 'Robinson Research Institute and Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia; Fertility SA, Adelaide, South Australia, Australia.'}, {'ForeName': 'Ben Willem', 'Initials': 'BW', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, School of Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Tuong Manh', 'Initials': 'TM', 'LastName': 'Ho', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam; HOPE Research Center, My Duc Hospital, Ho Chi Minh City, Vietnam.'}]",Fertility and sterility,['10.1016/j.fertnstert.2020.04.041'] 613,32567433,Glycemic variability in type 2 diabetes mellitus and acute coronary syndrome: liraglutide compared with insulin glargine: a pilot study.,"OBJECTIVE To explore the glucagon-like peptide-1 analogue liraglutide in the hospital setting in patients with type 2 diabetes mellitus (T2DM) and acute coronary syndrome and to evaluate the safety and efficacy and its impact on hospitalization and short-term glycemic variability (GV). METHODS A 12-week, open-label, prospective, randomized pilot clinical study with parallel groups that compared liraglutide (group 1) with glargine (group 2) and its impact on glycemic control and GV. RESULTS Thirteen patients were included. During hospitalization, mean glucose was 164.75 mg/dL (standard deviation [SD] 19.94) in group 1 and 166.69 mg/dL (38.22) in group 2. GV determined by CV and SD was 20.98 (7.68) vs. 25.48 (7.19) and 34.37 (13.05) vs. 43.56 (19.53) in groups 1 and 2, respectively. Group 1 prandial insulin requirements during hospitalization were lower compared with group 2. Follow-up A1c in group 1 was 6.9% (-1.51%) and 6.5% in group 2 (-1.27). GV after discharge and hypoglycemia were lower in group 1 compared with group 2. CONCLUSIONS Liraglutide seems to reduce GV in the acute phase of acute coronary syndrome, and patients achieved optimal control with a low incidence of hypoglycemia. These results support the need to explore liraglutide in a larger multicenter trial. Trial registration: The study was approved by the National Medical Ethics Committee of Spain. The study was registered at European Clinical Trials Database (EudraCT): 2014003298-40.",2020,"GV after discharge and hypoglycemia were lower in group 1 compared with group 2. ","['patients with type 2 diabetes mellitus (T2DM) and acute coronary syndrome', 'Thirteen patients were included', 'type 2 diabetes mellitus and acute coronary syndrome']","['glargine', 'liraglutide', 'Liraglutide', 'glucagon-like peptide-1 analogue liraglutide', 'insulin glargine']","['GV determined by CV and SD', 'GV after discharge and hypoglycemia', 'Glycemic variability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}]","[{'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}]",13.0,0.0629473,"GV after discharge and hypoglycemia were lower in group 1 compared with group 2. ","[{'ForeName': 'Maria Isabel', 'Initials': 'MI', 'LastName': 'Del Olmo-García', 'Affiliation': 'Hospital Universitario La Fe (Valencia), Valenciana, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hervás Marín', 'Affiliation': 'Unidad Bioestadistica, Instituto de Investigación Sanitaria IIS La Fe (Valencia), Valenciana, Spain.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Caudet Esteban', 'Affiliation': 'Hospital Universitario La Fe (Valencia), Valenciana, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ballesteros Martin-Portugués', 'Affiliation': 'Hospital Universitario La Fe (Valencia), Valenciana, Spain.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Cerveró Rubio', 'Affiliation': 'Hospital Universitario La Fe (Valencia), Valenciana, Spain.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Arnau Vives', 'Affiliation': 'Hospital Universitario La Fe (Valencia), Valenciana, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Catalá Gregori', 'Affiliation': 'Unidad Mixta Investigacion Endocrinología, Nutrición y Dietética, IIS La Fe, Valenciana, Spain.'}, {'ForeName': 'Maite', 'Initials': 'M', 'LastName': 'Penalba Martínez', 'Affiliation': 'Hospital Universitario La Fe (Valencia), Valenciana, Spain.'}, {'ForeName': 'Juan Francisco', 'Initials': 'JF', 'LastName': 'Merino-Torres', 'Affiliation': 'Hospital Universitario La Fe (Valencia), Valenciana, Spain.'}]",The Journal of international medical research,['10.1177/0300060520926063'] 614,32567438,Brief cycles of lower-limb occlusion accelerate recovery kinetics in soccer players.,"Objective: The aim of this study was to assess the effect of intermittent vascular occlusion (IVO) on recovery following simulated soccer physical demand test in soccer players. Methods: Twelve soccer players completed the Loughborough Intermittent Shuttle Test (LIST) in two conditions placebo (PLA) and IVO followed by intermittent lower-limb occlusion. Physical performance (Squat jump: SJ, countermovement jump: CMJ, maximal voluntary contraction: MVC, and 20 m sprint: SP), muscle damage parameters (creatine kinase: CK, Lactate dehydrogenase: LDH), inflammatory parameter (C-reactive protein: CRP), and perceived muscle soreness (DOMS) were assessed before, immediately after (0 h), and 24 h, 48 h, and 72 h following the exercise. Results: Following the LIST, a decrease was observed in all Physical performance within 48 h in PLA condition (p < 0.05), compared to PLA treatment, IVO treatment attenuated the decrease of SJ and CMJ at 24 h and at 48 h and for MVC and SP within 48 h after the LIST (p < 0.05). CK and LDH levels increased within 24 h post-exercise in both conditions (p < 0.05), but with a lower level in IVO compared to PLA condition (p < 0.05). Likewise, DOMS values were significantly lower with IVO condition compared to PLA condition immediately and at 24 h after exercise. Conclusion: The results of the present study suggest that the application of IVO after simulated soccer physical demand test accelerated recovery kinetics in soccer players.",2021,"CK and LDH levels increased within 24h post exercise in both conditions (p<0.05), but with a lower level in IVO compared to PLA condition (p<0.05).","['Twelve soccer players completed the', 'soccer players']","['Loughborough Intermittent Shuttle Test (LIST) in two conditions placebo (PLA) and IVO followed by intermittent lower limb occlusion', 'intermittent vascular occlusion (IVO']","['Likewise, DOMS values', 'SJ and CMJ', 'CK and LDH levels', 'Physical performance (Squat jump: SJ, countermovement jump: CMJ, maximal voluntary contraction: MVC, and 20 meters sprint: SP), muscle damage parameters (creatine kinase: CK, Lactate dehydrogenase: LDH), inflammatory parameter (C-reactive protein: CRP) and perceived muscle soreness (DOMS', 'Physical performance']","[{'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0430518', 'cui_str': 'Shuttle test'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1096458', 'cui_str': 'Vascular occlusion'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}]","[{'cui': 'C0013007', 'cui_str': 'Methyldimethoxyamphetamine'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}]",,0.0603503,"CK and LDH levels increased within 24h post exercise in both conditions (p<0.05), but with a lower level in IVO compared to PLA condition (p<0.05).","[{'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Daab', 'Affiliation': 'UR15JS01: Education, Motricité, Sport Et Santé (EM2S), High Institute of Sport and Physical Education, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Mohamed Amine', 'Initials': 'MA', 'LastName': 'Bouzid', 'Affiliation': 'UR15JS01: Education, Motricité, Sport Et Santé (EM2S), High Institute of Sport and Physical Education, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Lajri', 'Affiliation': 'UR15JS01: Education, Motricité, Sport Et Santé (EM2S), High Institute of Sport and Physical Education, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Mustapha', 'Initials': 'M', 'LastName': 'Bouchiba', 'Affiliation': 'UR15JS01: Education, Motricité, Sport Et Santé (EM2S), High Institute of Sport and Physical Education, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Haithem', 'Initials': 'H', 'LastName': 'Rebai', 'Affiliation': 'UR15JS01: Education, Motricité, Sport Et Santé (EM2S), High Institute of Sport and Physical Education, University of Sfax, Sfax, Tunisia.'}]",The Physician and sportsmedicine,['10.1080/00913847.2020.1785260'] 615,32030615,Bariatric Support Groups Predicts Long-term Weight Loss.,"BACKGROUND Support groups are an integral part of bariatric surgery (BS) programs yet there is limited evidence for an association between support group attendance and BS weight outcomes. SETTINGS University Hospital, Spain. OBJECTIVES This study examined the effect of support group attendance on weight loss (WL) at short- and long-term follow-up (FU) following BS. METHODS Participants were 531 (mean body mass index (BMI) = 45.8 (5.4) kg/m 2 ; mean age 45.9 (11.1) years, 76.4% females) who underwent BS (Roux-en-Y gastric bypass (RYGB): 233 (43.8%); sleeve gastrectomy (SG): 298 (56.2%)) in our clinic. The bariatric support group program (BSGP) consisted of two subprograms: Novel-BSGP (N-BSGP; first 12 months after surgery) and Experienced-BSGP (E-BSGP; FU between 12 months 5 years after BS). RESULTS Three hundred and twenty-three (60.8%) and 129 (24.3%) participants attended at least one session of N-BSGP and E-BSGP, respectively. Linear regression analyses showed that number of sessions attended during year 1 predicted percent total body WL (%TBWL (β = 0.381, p < 0.001)) and percent excess WL (%EWL (β = 0.928, p < 0.001)) at one year and number of sessions attended during years 2-5 were positively related to %TBWL and %EWL achieved at 5 years (%EWL: β = 0.162 (p = 0.014) and %TBWL: β = 0.378 (p = 0.013)) respectively. CONCLUSION We observed a significant beneficial effect of a post-surgical support group program on short- and long-term body WL after BS.",2020,We observed a significant beneficial effect of a post-surgical support group program on short- and long-term body WL after BS.,"['Three hundred and twenty-three (60.8%) and 129 (24.3', '5.4) kg/m 2 ; mean age 45.9 (11.1) years, 76.4% females) who underwent BS (Roux-en-Y gastric bypass (RYGB): 233 (43.8%); sleeve gastrectomy (SG): 298 (56.2%)) in our clinic', 'University Hospital, Spain', 'Participants were 531 (mean body mass index (BMI)\u2009=\u200945.8']",['Novel-BSGP (N-BSGP'],"['weight loss (WL', 'total body WL']","[{'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",[],"[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",531.0,0.0427205,We observed a significant beneficial effect of a post-surgical support group program on short- and long-term body WL after BS.,"[{'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Andreu', 'Affiliation': 'Obesity Unit, Hospital Clinic Barcelona, Villarroel 170, 08036, Barcelona, Spain.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Jimenez', 'Affiliation': 'Obesity Unit, Hospital Clinic Barcelona, Villarroel 170, 08036, Barcelona, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Vidal', 'Affiliation': 'Obesity Unit, Hospital Clinic Barcelona, Villarroel 170, 08036, Barcelona, Spain.'}, {'ForeName': 'Ainitze', 'Initials': 'A', 'LastName': 'Ibarzabal', 'Affiliation': 'Obesity Unit, Hospital Clinic Barcelona, Villarroel 170, 08036, Barcelona, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'De Hollanda', 'Affiliation': 'Obesity Unit, Hospital Clinic Barcelona, Villarroel 170, 08036, Barcelona, Spain.'}, {'ForeName': 'Lilliam', 'Initials': 'L', 'LastName': 'Flores', 'Affiliation': 'Obesity Unit, Hospital Clinic Barcelona, Villarroel 170, 08036, Barcelona, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Cañizares', 'Affiliation': 'Obesity Unit, Hospital Clinic Barcelona, Villarroel 170, 08036, Barcelona, Spain.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Molero', 'Affiliation': 'Obesity Unit, Hospital Clinic Barcelona, Villarroel 170, 08036, Barcelona, Spain.'}, {'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'Moizé', 'Affiliation': 'Obesity Unit, Hospital Clinic Barcelona, Villarroel 170, 08036, Barcelona, Spain. vmoize@clinic.cat.'}]",Obesity surgery,['10.1007/s11695-020-04434-2'] 616,32439189,The Use of Topical Nitroglycerin to Facilitate Radial Arterial Catheter Insertion in Children: A Randomized Controlled Trial.,"OBJECTIVES To determine whether the use of topical nitroglycerin patch increases radial artery diameter and facilitate cannulation in children. DESIGN Randomized controlled trial. SETTING Cairo University Hospital. PARTICIPANTS Children aged 2 to 8 years old scheduled for cardiac surgery. INTERVENTION In the nitroglycerin group (n = 20), a gauze-covered, half-sized nitroglycerin patch (5 mg) was applied at the site of radial pulsation 1 hour before induction of anesthesia. In the control group (n = 20), a gauze pad was applied to the bare skin at the site of radial pulsation with no intervention. MEASUREMENTS AND MAIN RESULTS The primary outcome was the diameter of the radial artery in both limbs using ultrasonography. Other outcomes included the degree of arterial palpability, number of arterial punctures, and incidence of successful first puncture cannulation. The radial artery diameter increased after 30 minutes and 60 minutes compared with the baseline value in the nitroglycerin group in both limbs, whereas no change was reported in the radial artery diameter in the control group. The nitroglycerin group showed a greater incidence of successful first cannulation trial, a fewer number of trials, and a shorter cannulation time compared with the control group. There were no significant hypotensive episodes in any patient. CONCLUSION Local application of a half-sized, 5 mg nitroglycerin patch for 60 minutes in children increased the radial artery diameter bilaterally, increased the rate of first trial success, and decreased the time needed for arterial cannulation without significant hypotensive episodes.",2020,"The radial artery diameter increased after 30 minutes and 60 minutes compared with the baseline value in the nitroglycerin group in both limbs, whereas no change was reported in the radial artery diameter in the control group.","['Cairo University Hospital', 'Children', 'Children ages 2 to 8 years old scheduled for cardiac surgery', 'children']","['topical nitroglycerin patch', 'nitroglycerin patch', 'Topical Nitroglycerin', 'nitroglycerin', 'gauze-covered, half-sized nitroglycerin patch']","['radial artery diameter', 'time needed for arterial cannulation', 'shorter cannulation time', 'degree of arterial palpability, number of arterial punctures, and incidence of successful first puncture cannulation', 'incidence of successful first cannulation trial', 'radial artery diameter bilaterally', 'diameter of the radial artery in both limbs using ultrasonography', 'rate of first trial success', 'hypotensive episodes']","[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0699222', 'cui_str': 'Nitroglycerin Transdermal System'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C0590323', 'cui_str': 'Gauzes'}, {'cui': 'C0439844', 'cui_str': 'Covered'}]","[{'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0189586', 'cui_str': 'Puncture of artery'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0520541', 'cui_str': 'Hypotensive episode'}]",,0.261277,"The radial artery diameter increased after 30 minutes and 60 minutes compared with the baseline value in the nitroglycerin group in both limbs, whereas no change was reported in the radial artery diameter in the control group.","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hasanin', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Amel', 'Initials': 'A', 'LastName': 'Aboelela', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Mostafa', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt. Electronic address: maha.mostafa@cu.edu.eg.'}, {'ForeName': 'Rehab Mohamed', 'Initials': 'RM', 'LastName': 'Mansour', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Kareem', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.04.035'] 617,31471739,Narrow-band imaging assisted cystoscopy in the follow-up of patients with transitional cell carcinoma of the bladder: a randomized study in comparison with white light cystoscopy.,"PURPOSE To evaluate the diagnostic accuracy of a second look narrow-band imaging (NBI) cystoscopy in the follow-up of patients with NMIBC as compared to a second white light cystoscopy (WLI). PATIENTS AND METHODS From August 2013 to October 2014, 600 patients with history of non-muscle invasive bladder cancer (NMIBC), who presented for follow-up cystoscopy at an academic outpatient clinic, were randomized to flexible WLI-cystoscopy plus second look NBI-cystoscopy (n = 300) or flexible WLI-cystoscopy plus second look WLI-cystoscopy (n = 300) in the same session. We analysed the detection rate of bladder tumours in second look cystoscopy as primary endpoint. In addition, we evaluated recurrence rates before study enrolment and after transurethral resection (TUR-BT) in each group. RESULTS In 600 patients with a history of NMIBC, 78 out of 300 patients (26%) with WLI-NBI-cystoscopy and 70 out of 300 patients (23%) with WLI-WLI-cystoscopy were diagnosed with cancer recurrence (p = 0.507). Overall, WLI-NBI detected 404 and WLI-WLI 234 lesions, respectively. The second look cystoscopy detected 57 additional cancer lesions: 45 tumours in 18 patients with WLI-NBI and 12 tumours in 9 patients with WLI-WLI (p = 0.035). After initial examination without tumour detection an improvement was determined by the second cystoscopy in 3 patients (75 vs. 78 pat.) with WLI-NBI and in only one patient (69 vs. 70 pat.) with WLI-WLI (p = 0.137). Second look cystoscopy did not influence the detection of carcinoma in situ in both groups (p = 0.120). After TUR-BT the median recurrence-free survival was 4 months in 57 recurring patients (73%) in the group with WLI-NBI- and 6 months in 56 patients (80%) with WLI-WLI-cystoscopy (p = 0.373), respectively. CONCLUSION Our study showed no differences in per-patient tumour detection between WLI and NBI. Although NBI has significant benefits for detecting individual lesions overlooked by WLI-cystoscopy, this did not positively affect recurrence-free survival after transurethral resection.",2020,Second look cystoscopy did not influence the detection of carcinoma in situ in both groups (p = 0.120).,"['600 patients with a history of NMIBC, 78 out of 300 patients', '18 patients with WLI-NBI and 12 tumours in 9 patients with WLI-WLI (p\u2009=\u20090.035', 'patients with transitional cell carcinoma of the bladder', 'patients with NMIBC as compared to a second white light cystoscopy (WLI', 'From August 2013 to October 2014, 600 patients with history of non-muscle invasive bladder cancer (NMIBC), who presented for follow-up cystoscopy at an academic outpatient clinic']","['transurethral resection (TUR-BT', 'Narrow-band imaging assisted cystoscopy', 'white light cystoscopy', 'flexible WLI-cystoscopy plus second look NBI-cystoscopy (n\u2009=\u2009300) or flexible WLI-cystoscopy plus second look WLI-cystoscopy', 'second look narrow-band imaging (NBI) cystoscopy']","['median recurrence-free survival', 'cancer recurrence', 'detection rate of bladder tumours', 'recurrence-free survival', 'detection of carcinoma', 'recurrence rates']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C4517405', 'cui_str': '0.035'}, {'cui': 'C0007138', 'cui_str': 'Carcinoma, Transitional Cell'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0563228', 'cui_str': 'White light (physical force)'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}]","[{'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C3494253', 'cui_str': 'Narrowband Imaging'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}, {'cui': 'C0563228', 'cui_str': 'White light (physical force)'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3854333', 'cui_str': 'Narrowing'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0007097', 'cui_str': 'Epithelioma'}]",600.0,0.0533585,Second look cystoscopy did not influence the detection of carcinoma in situ in both groups (p = 0.120).,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tschirdewahn', 'Affiliation': 'Department of Urology, University Hospital Essen, University of Duisburg-Essen, Duisburg, Germany.'}, {'ForeName': 'N N', 'Initials': 'NN', 'LastName': 'Harke', 'Affiliation': 'Department of Urology, University Hospital Essen, University of Duisburg-Essen, Duisburg, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Hirner', 'Affiliation': 'Department of Urology, University Hospital Essen, University of Duisburg-Essen, Duisburg, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Stagge', 'Affiliation': 'Outpatient Clinic Praxisklinik für Urologie Rhein/Ruhr, Schulstr. 11, 45468, Mülheim an der Ruhr, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hadaschik', 'Affiliation': 'Department of Urology, University Hospital Essen, University of Duisburg-Essen, Duisburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Eisenhardt', 'Affiliation': 'Department of Urology, University Hospital Essen, University of Duisburg-Essen, Duisburg, Germany. a.eisenhardt@pur-r.de.'}]",World journal of urology,['10.1007/s00345-019-02926-0'] 618,32495663,Multiple-dose versus single-dose gonadotropin-releasing hormone agonist after first in vitro fertilization failure associated with luteal phase deficiency: A randomized controlled trial.,"OBJECTIVE To evaluate the efficacy and safety of multiple- versus single-dose gonadotropin-releasing hormone agonist (GnRH-a) addition to luteal phase support (LPS), in patients with a first in vitro fertilization (IVF) failure associated with luteal phase deficiency (LPD). METHODS Eighty patients with a first IVF failure associated with LPD were randomly assigned into single-dose and multiple-dose GnRH-a groups. In the second IVF attempt, patients in the single-dose group were given standard LPS plus a single dose of GnRH-a 6 days after oocyte retrieval. Patients in the multiple-dose group received standard LPS plus 14 daily injections of GnRH-a. Children conceived were followed up for 2 years. RESULTS Pregnancy (67.5% vs. 42.5%), clinical pregnancy (50.0% vs. 22.5%), and live birth rates (42.5% vs. 20.0%) were significantly higher in the multiple-dose versus single-dose GnRH-a group. Patients in the multiple-dose GnRH-a group had significantly higher progesterone levels 14 days after oocyte recovery (35.9 vs. 21.4 ng/mL). No significant difference existed in the status at birth or developmental and behavior assessments of 2-year-old children conceived in both groups. CONCLUSIONS Daily addition of GnRH-a to standard LPS can achieve better pregnancy outcomes with a sustained safety profile in patients with a first IVF failure associated with LPD.",2020,"No significant difference existed in the status at birth or developmental and behavior assessments of 2-year-old children conceived in both groups. ","['patients with a first in vitro fertilization (IVF) failure associated with luteal phase deficiency (LPD', 'vitro fertilization failure associated with luteal phase deficiency', 'patients with a first IVF failure associated with LPD', 'Eighty patients with a first IVF failure associated with LPD']","['multiple- versus single-dose gonadotropin-releasing hormone agonist (GnRH-a) addition to luteal phase support (LPS', 'standard LPS plus 14 daily injections of GnRH-a', 'standard LPS', 'Multiple-dose versus single-dose gonadotropin-releasing hormone agonist']","['live birth rates', 'status at birth or developmental and behavior assessments of 2-year-old children', 'efficacy and safety', 'progesterone levels', 'clinical pregnancy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0404576', 'cui_str': 'Luteal phase defect'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C3816958', 'cui_str': '80'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0024153', 'cui_str': 'Menstrual Cycle, Luteal Phase'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}]","[{'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C1160858', 'cui_str': 'Behavior assessment'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0428409', 'cui_str': 'Progesterone level'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]",80.0,0.0718243,"No significant difference existed in the status at birth or developmental and behavior assessments of 2-year-old children conceived in both groups. ","[{'ForeName': 'Danni', 'Initials': 'D', 'LastName': 'Qu', 'Affiliation': 'Medical Center for Human Reproduction, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Medical Center for Human Reproduction, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.'}]",The Journal of international medical research,['10.1177/0300060520926026'] 619,9773139,Retracted: Influence of dopexamine hydrochloride on haemodynamics and regulators of circulation in patients undergoing major abdominal surgery.,"BACKGROUND Catecholaminergic support is often used to improve haemodynamics in patients undergoing major abdominal surgery. Dopexamine is a synthetic vasoactive catecholamine with beneficial microcirculatory properties. METHODS The influence of perioperative administration of dopexamine on cardiorespiratory data and important regulators of macro- and microcirculation were studied in 30 patients undergoing Whipple pancreaticduodenectomy. The patients received randomized and blinded either 2 micrograms.kg-1.min-1 of dopexamine (n = 15) or placebo (n = 15, control group). The infusion was started after induction of anaesthesia and continued until the morning of the first postoperative day. Endothelin-1 (ET-1), vasopressin, atrial natriuretic peptide (ANP), and catecholamine plasma levels were measured from arterial blood samples. Measurements were carried out after induction of anaesthesia, 2 h after onset of surgery, at the end of surgery, 2 h after surgery, and on the morning of the first postoperative day. RESULTS Cardiac index (CI) increased significantly in the dopexamine group (from 2.61 +/- 0.41 to 4.57 +/- 0.78 l.min-1.m-2) and remained elevated until the morning of the first postoperative day. Oxygen delivery index (DO2I) and oxygen consumption index (VO2I) were also significantly increased in the dopexamine group (DO2I: from 416 +/- 91 to 717 +/- 110 ml/m2.m2; VO2I: from 98 +/- 25 to 157 +/- 22 ml/m2.m2), being significantly higher than in the control group. pHi remained stable only in the dopexamine patients, indicating adequate splanchnic perfusion. Vasopressive regulators of circulation increased significantly only in the untreated control patients (vasopressin: from 4.37 +/- 1.1 to 35.9 +/- 12.1 pg/ml; ET-1: from 2.88 +/- 0.91 to 6.91 +/- 1.20 pg/ml). CONCLUSION Patients undergoing major abdominal surgery may profit from prophylactic perioperative administration of dopexamine hydrochloride in the form of improved haemodynamics and oxygenation as well as beneficial influence on important regulators of organ blood flow.",1998,Oxygen delivery index (DO2I) and oxygen consumption index (VO2I) were also significantly increased in the dopexamine group (DO2I: from 416 +/-,"['Patients undergoing major abdominal surgery', 'patients undergoing major abdominal surgery', '30 patients undergoing Whipple pancreaticduodenectomy']","['dopexamine', 'dopexamine hydrochloride', 'placebo', 'Dopexamine']","['Vasopressive regulators of circulation', 'adequate splanchnic perfusion', 'haemodynamics and regulators of circulation', 'Cardiac index (CI', 'Oxygen delivery index (DO2I) and oxygen consumption index (VO2I', 'Endothelin-1 (ET-1), vasopressin, atrial natriuretic peptide (ANP), and catecholamine plasma levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0058702', 'cui_str': 'dopexamine'}, {'cui': 'C0770936', 'cui_str': 'Dopexamine hydrochloride'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index (observable entity)'}, {'cui': 'C0429622', 'cui_str': 'Oxygen delivery (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0201849', 'cui_str': 'Antidiuretic hormone measurement (procedure)'}, {'cui': 'C0027481', 'cui_str': 'Atriopeptins'}, {'cui': 'C0007412', 'cui_str': 'Sympathins'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",30.0,0.0374645,Oxygen delivery index (DO2I) and oxygen consumption index (VO2I) were also significantly increased in the dopexamine group (DO2I: from 416 +/-,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Boldt', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Klinikum der Stadt Ludwigshafen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Papsdorf', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Piper', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Padberg', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Hempelmann', 'Affiliation': ''}]",Acta anaesthesiologica Scandinavica,[] 620,32493523,Protein and carbohydrate distribution among the meals: effect on metabolic parameters of patients with type 2 diabetes: a single-blinded randomised controlled trial.,"Studies have revealed that the timing of macronutrient ingestion may influence body weight and glucose tolerance. We aimed to examine the effect of high protein v. high carbohydrate intake at the evening meal on metabolic parameters of patients with type 2 diabetes. This is a single-blinded, parallel, randomised controlled trial. Ninety-six patients with type 2 diabetes, aged 32-65 years with a mean BMI of 28·5 (sd 3·4) kg/m2, were randomly assigned into one of these three groups: standard evening meal (ST), high-carbohydrate evening meal (HC) and high-protein evening meal (HP). Then, the patients were followed for 10 weeks. HbA1c, fasting blood glucose, fasting insulin, insulin resistance, TAG, LDL-cholesterol, VLDL-cholesterol, diastolic blood pressure, body weight, body fat percentage and waist circumference decreased significantly in all three groups (P < 0·05). HbA1c showed more improvement in the ST compared with the HP group (-0·45 (sd 0·36) v. -0·26 (sd 0·36)). Reductions in BMI and body weight were significantly higher in the ST compared with the HP group (P < 0·05). Reductions in total cholesterol, non-HDL-cholesterol and systolic blood pressure were significant in all groups, except for the HP group. Non-HDL-cholesterol:HDL-cholesterol remained unchanged in all groups. The results of the present study revealed that even distribution of carbohydrates and protein among meals compared with reducing carbohydrates and increasing protein at dinner may have a more beneficial effect on glycaemic control of patients with type 2 diabetes.",2021,Reductions in BMI and body weight were significantly higher in the ST compared with the HP group (P < 0.05).,"['96 patients with type 2 diabetes, aged 32-65 years with a mean body mass index (BMI) of 28.5 ± 3.4 kg/m2', 'patients with type 2 diabetes', 'patients with type']","['high protein versus high carbohydrate intake', 'Standard evening meal (ST), High carbohydrate evening meal (HC), and High protein evening meal (HP']","['body weight and glucose tolerance', 'BMI and body weight', 'HbA1c, fasting blood glucose (FBG), fasting insulin, insulin resistance, triglyceride, low-density lipoprotein cholesterol (LDL-C), very-low-density lipoprotein cholesterol (VLDL-C), diastolic blood pressure, body weight, body fat percentage, and waist circumference', 'metabolic parameters', 'total cholesterol, non-high-density lipoprotein cholesterol (non-HDL-C), and systolic blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0585040', 'cui_str': 'Evening meal'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023826', 'cui_str': 'VLDL cholesterol'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",96.0,0.0232922,Reductions in BMI and body weight were significantly higher in the ST compared with the HP group (P < 0.05).,"[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Nouripour', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, 71348-14336, Iran.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Mazloom', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, 71348-14336, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Fararouei', 'Affiliation': 'Department of Epidemiology, School of Health, Shiraz University of Medical Sciences, Shiraz, 71348-14336, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Zamani', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Endocrinology and Metabolism Research Center, Shiraz University of Medical Sciences, Shiraz, 71936-13311, Iran.'}]",The British journal of nutrition,['10.1017/S0007114520001944'] 621,32508218,The Effects of Algebraic Equation Solving Intervention for Students With Mathematics Learning Difficulties.,"The purpose of this study was to examine the effects of algebraic equation solving intervention for sixth graders with mathematics learning difficulties (MD). A total of 48 students with MD were randomly assigned to either the algebraic equation solving intervention, Mystery Math ( n = 24) or control condition ( n = 24). The multicomponent intervention was based on the principles of explicit instruction and focused on improving conceptual and procedural knowledge of algebraic equation solving using concrete manipulatives. Students in the intervention group received instruction in pairs, 30 min per session, 3 sessions per week for 5 weeks (i.e., 15 sessions). The results indicated that the main effect of intervention was significant for 2 proximal measures of mathematics vocabulary, and conceptual and procedural understanding of algebraic equation solving with large effect sizes. However, the main effect of intervention was not significant for distal measures of comprehensive pre-algebra skills and whole-number computations. The findings demonstrate that grade-level standards can be successfully taught to students with MD. Implications for practice are discussed.",2021,"However, the main effect of intervention was not significant for distal measures of comprehensive pre-algebra skills and whole-number computations.","['sixth graders with mathematics learning difficulties (MD', 'Students With Mathematics Learning Difficulties', '48 students with MD']","['Algebraic Equation Solving Intervention', 'algebraic equation solving intervention, Mystery Math ( n = 24) or control condition', 'algebraic equation solving intervention']","['2 proximal measures of mathematics vocabulary, and conceptual and procedural understanding of algebraic equation solving']","[{'cui': 'C0205440', 'cui_str': 'Sixth'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0424939', 'cui_str': 'Learning difficulties'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}]",48.0,0.0172868,"However, the main effect of intervention was not significant for distal measures of comprehensive pre-algebra skills and whole-number computations.","[{'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Namkung', 'Affiliation': 'University of Nebraska-Lincoln, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Bricko', 'Affiliation': 'University of Nebraska-Lincoln, USA.'}]",Journal of learning disabilities,['10.1177/0022219420930814'] 622,32511726,Intraindividual variability in sleep schedule: effects of an internet-based cognitive-behavioral therapy for insomnia program and its relation with symptom remission.,"STUDY OBJECTIVES Sleep schedule consistency is fundamental to cognitive-behavioral therapy for insomnia (CBT-I), although there is limited evidence suggesting whether it predicts treatment response. This analysis tested whether: (1) an Internet-based CBT-I program affects intraindividual variability (IIV) in sleep schedule and (2) sleep schedule IIV predicts insomnia symptom remission. METHODS This secondary analysis compares participants (N = 303) randomized to an Internet-based CBT-I program (SHUTi-Sleep Healthy Using the Internet) or Internet-based patient education (PE). Participants reported daily bedtimes and rising times on 10 online sleep diaries collected over 2 weeks at baseline and 9-week post-intervention assessment. Participants completed the Insomnia Severity Index (ISI) at post-assessment and 6-month follow-up; symptom remission was defined by ISI < 8. Mixed effects location scale modeling was used to examine the effect of SHUTi on bedtime and rising time IIV; a novel two-staged analysis examined the effect of bedtime and rising time IIV on insomnia symptom remission. RESULTS At post-assessment, SHUTi participants reported about 30% less bedtime and 32% less rising time variability compared to PE (ps < 0.03). Bedtime and rising time IIV was not independently associated with likelihood of insomnia symptom remission at the subsequent time point (ps > 0.18), nor did sleep schedule IIV moderate treatment response (ps > 0.12). CONCLUSIONS Findings demonstrate that an Internet-delivered CBT-I program can effectively increase users' sleep schedule consistency relative to an educational control. This consistency, however, was not related to treatment outcome when defined by insomnia symptom remission, suggesting that enforcing rigid sleep schedules for patients may not be necessary for treatment success. CLINICAL TRIAL REGISTRATION NCT00328250.",2020,"IIV was not independently associated with likelihood of insomnia symptom remission at the subsequent time point (ps>.18), nor did sleep schedule IIV moderate treatment response (ps>.12). ",[],"['Internet-based CBT-I program (SHUTi - Sleep Healthy Using the Internet) or Internet-based patient education (PE', 'Internet-Based Cognitive-Behavioral Therapy', 'SHUTi']","['daily bedtimes and rising times on ten online sleep diaries', 'insomnia symptom remission', 'rising time variability', 'Insomnia Severity Index (ISI', 'symptom remission', 'Bedtime and rising time']",[],"[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}]",303.0,0.0636908,"IIV was not independently associated with likelihood of insomnia symptom remission at the subsequent time point (ps>.18), nor did sleep schedule IIV moderate treatment response (ps>.12). ","[{'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Shaffer', 'Affiliation': 'Center for Behavioral Health and Technology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Hedeker', 'Affiliation': 'Department of Public Health Sciences, University of Chicago, Chicago, IL.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Morin', 'Affiliation': 'Department of Psychology, Laval University, Québec, QC, Canada.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Ingersoll', 'Affiliation': 'Center for Behavioral Health and Technology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Thorndike', 'Affiliation': 'Pear Therapeutics, Inc, Boston, MA.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Ritterband', 'Affiliation': 'Center for Behavioral Health and Technology, University of Virginia, Charlottesville, VA.'}]",Sleep,['10.1093/sleep/zsaa115'] 623,32521358,Protocol for a partially nested randomised controlled trial to evaluate the effectiveness of the scleroderma patient-centered intervention network COVID-19 home-isolation activities together (SPIN-CHAT) program to reduce anxiety among at-risk scleroderma patients.,"OBJECTIVE Contagious disease outbreaks and related restrictions can lead to negative psychological outcomes, particularly in vulnerable populations at risk due to pre-existing medical conditions. No randomised controlled trials (RCTs) have tested interventions to reduce mental health consequences of contagious disease outbreaks. The primary objective of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Trial is to evaluate the effect of a videoconference-based program on symptoms of anxiety. Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction. METHODS The SPIN-CHAT Trial is a pragmatic RCT that will be conducted using the SPIN-COVID-19 Cohort, a sub-cohort of the SPIN Cohort. Eligible participants will be SPIN-COVID-19 Cohort participants without a positive COVID-19 test, with at least mild anxiety (PROMIS Anxiety 4a v1.0 T-score ≥ 55), not working from home, and not receiving current counselling or psychotherapy. We will randomly assign 162 participants to intervention groups of 7 to 10 participants each or waitlist control. We will use a partially nested RCT design to reflect dependence between individuals in training groups but not in the waitlist control. The SPIN-CHAT Program includes activity engagement, education on strategies to support mental health, and mutual participant support. Intervention participants will receive the 4-week (3 sessions per week) SPIN-CHAT Program via videoconference. The primary outcome is PROMIS Anxiety 4a score immediately post-intervention. ETHICS AND DISSEMINATION The SPIN-CHAT Trial will test whether a brief videoconference-based intervention will improve mental health outcomes among at-risk individuals during contagious disease outbreak.",2020,"Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction. ","['Eligible participants will be SPIN-COVID-19 Cohort participants without a positive COVID-19 test, with at least mild anxiety (PROMIS Anxiety 4a v1.0 T-score\u202f≥\u202f55), not working from home, and not receiving current counselling or psychotherapy', '162 participants to intervention groups of 7 to 10 participants each or', 'at-risk scleroderma patients']","['Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities', 'videoconference-based intervention', 'scleroderma patient-centered intervention network COVID-19 home-isolation activities together (SPIN-CHAT) program', 'Together (SPIN-CHAT', 'waitlist control', 'videoconference-based program']","['symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction', 'PROMIS Anxiety 4a score immediately post-intervention', 'mental health outcomes', 'symptoms of anxiety']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0231401', 'cui_str': 'Mild anxiety'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0006019', 'cui_str': 'Boredom'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",162.0,0.100017,"Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction. ","[{'ForeName': 'Brett D', 'Initials': 'BD', 'LastName': 'Thombs', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada; Department of Medicine, McGill University, Montreal, Quebec, Canada; Department of Psychology, McGill University, Montreal, Quebec, Canada; Department of Educational and Counselling Psychology, McGill University, Montreal, Quebec, Canada; Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada. Electronic address: brett.thombs@mcgill.ca.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Kwakkenbos', 'Affiliation': 'Department of Clinical Psychology, Behavioural Science Institute, Radboud University, Nijmegen, the Netherlands.'}, {'ForeName': 'Marie-Eve', 'Initials': 'ME', 'LastName': 'Carrier', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Bourgeault', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Tao', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Harb', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Gagarine', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Rice', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychology, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bustamante', 'Affiliation': 'Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Ellis', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Delaney', 'Initials': 'D', 'LastName': 'Duchek', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Parash Mani', 'Initials': 'PM', 'LastName': 'Bhandari', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Dipika', 'Initials': 'D', 'LastName': 'Neupane', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Carboni-Jiménez', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Henry', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Krishnan', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Levis', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada; Centre for Prognosis Research, School of Primary, Community and Social Care, Keele University, Staffordshire, UK.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'He', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Turner', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Benedetti', 'Affiliation': 'Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada; Department of Medicine, McGill University, Montreal, Quebec, Canada; Respiratory Epidemiology and Clinical Research Unit, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Culos-Reed', 'Affiliation': 'Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada; Department of Oncology, Cumming School of Medicine, Calgary, Canada; Department of Psychosocial Resources, Tom Baker Cancer Centre, Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Ghassan', 'Initials': 'G', 'LastName': 'El-Baalbaki', 'Affiliation': 'Department of Psychology, Université du Québec à Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Hebblethwaite', 'Affiliation': 'Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Bartlett', 'Affiliation': 'Department of Medicine, McGill University, Montreal, Quebec, Canada; Research Institute, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dyas', 'Affiliation': 'Scleroderma Foundation Michigan Chapter, Southfield, MI, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Patten', 'Affiliation': ""Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada; Hotchkiss Brain Institute and O'Brien Institute for Public Health, University of Calgary, Calgary, Alberta, Canada.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Varga', 'Affiliation': 'Northwestern Scleroderma Program, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110132'] 624,32524145,Clinical Efficacy of Ultrasound-Mediated Transdermal Lidocaine and Capsaicin Delivery for the Treatment of Allodynia Caused by Herpes Zoster.,"OBJECTIVE To investigate the efficacy of ultrasound-mediated drug delivery for allodynia caused by herpes zoster. DESIGN Unblinded randomized controlled study with two treatment groups and an additional control group. SUBJECTS Patients hospitalized with allodynia caused by herpes zoster were enrolled. METHODS Patients were randomly assigned to three groups: ultrasound-mediated transdermal drug delivery (group U), lidocaine intradermal injection (group I), or control group (group C). The primary outcome was pain intensity associated with allodynia, assessed with the visual analog scale (VAS) while brushing the skin with clothing after treatment stimulated allodynia. The secondary outcomes included an emotional functioning score (ES), average gabapentin consumption, and incidence of adverse events of each group. RESULTS Sixty patients were enrolled in the study, but two of them failed to complete the treatment process. Therefore, 58 patients were included in the final analysis. All groups had lower VAS and ES scores after treatment compared with baseline. The VAS scores in groups U and I decreased significantly more than in group C (P < 0.05). Mean VAS scores in group U on days 1, 2, and 3 were lower than in group C (P < 0.01). ES was significantly lower in group U compared with groups I and C after treatment (P < 0.001). Average gabapentin consumption and incidence of adverse events in group C were higher than in the other two groups. CONCLUSIONS In this study of treatment of allodynia caused by herpetic zoster, ultrasound-mediated lidocaine and capsaicin delivery provided better pain relief and improved emotional functioning compared with intradermal blockade with local anesthetics.",2020,ES was significantly lower in group U compared with groups I and C after treatment (P < 0.001).,"['Allodynia Caused by Herpes Zoster', '58 patients were included in the final analysis', 'Patients', 'Sixty patients', 'Patients hospitalized with allodynia caused by herpes zoster were enrolled']","['Ultrasound-Mediated Transdermal Lidocaine and Capsaicin Delivery', 'lidocaine intradermal injection', 'ultrasound-mediated drug delivery', 'ultrasound-mediated transdermal drug delivery', 'lidocaine and capsaicin']","['pain intensity associated with allodynia, assessed with the visual analog scale (VAS', 'ES', 'Average gabapentin consumption and incidence of adverse events', 'pain relief and improved emotional functioning', 'Mean VAS scores', 'VAS and ES scores', 'emotional functioning score (ES), average gabapentin consumption, and incidence of adverse events of each group', 'VAS scores']","[{'cui': 'C0458247', 'cui_str': 'Allodynia'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0019360', 'cui_str': 'Herpes zoster'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0021489', 'cui_str': 'Intradermal injection'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0458247', 'cui_str': 'Allodynia'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",60.0,0.0551121,ES was significantly lower in group U compared with groups I and C after treatment (P < 0.001).,"[{'ForeName': 'Yue-E', 'Initials': 'YE', 'LastName': 'Dai', 'Affiliation': ""Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Shao-Xing', 'Initials': 'SX', 'LastName': 'Liu', 'Affiliation': ""Department of Anesthesiology, Chengdu Second People's Hospital, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Ye', 'Affiliation': ""Department of Pain Management, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Yun-Xia', 'Initials': 'YX', 'LastName': 'Zuo', 'Affiliation': ""Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu, Sichuan, People's Republic of China.""}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa137'] 625,32520623,Mineralocorticoid Receptor Antagonists for Hypertension Management in Advanced Chronic Kidney Disease: BLOCK-CKD Trial.,"Spironolactone, a steroidal mineralocorticoid receptor antagonist, is recommended as add-on therapy for treatment-resistant/uncontrolled hypertension. However, caution is advised in patients with advanced chronic kidney disease (CKD) due to an increased risk for hyperkalemia. KBP-5074 is a nonsteroidal mineralocorticoid receptor antagonist under investigation for the treatment of treatment-resistant and uncontrolled hypertension in patients with moderate-to-severe CKD. BLOCK-CKD is a phase 2, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of KBP-5074, on top of current therapy, in patients with stage 3B/4 CKD (estimated glomerular filtration rate ≥15 and ≤44 mL/[min·1.73 m 2 ]) and resistant hypertension (trough cuff seated systolic blood pressure ≥140 mm Hg, despite treatment with maximally tolerated doses of 2 or more antihypertensive medicines with complementary mechanisms). Patients (n=240) will be randomized 1:1:1 to once-daily treatment with KBP-5074 0.25 mg, KBP-5074 0.5 mg, or placebo, stratified by estimated glomerular filtration rate (≥30 versus <30 mL/[min·1.73 m 2 ]) and systolic blood pressure (≥160 versus <160 mm Hg). Approximately 30% of enrolled patients should have an estimated glomerular filtration rate of 15 to 29 mL/(min·1.73 m 2 ). The primary efficacy analysis is the change in trough cuff seated systolic blood pressure from baseline to day 84 for the KBP-5074 doses compared with placebo. Changes in urinary albumin-creatinine ratio will be assessed along with changes in serum potassium/incidence of hyperkalemia and changes in estimated glomerular filtration rate and serum creatinine. BLOCK-CKD will determine whether the addition of KBP-5074 will effectively lower blood pressure without an increased risk of hyperkalemia in patients who are not candidates for steroidal mineralocorticoid receptor antagonists due to advanced CKD. Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT03574363.",2020,BLOCK-CKD will determine whether the addition of KBP-5074 will effectively lower blood pressure without an increased risk of hyperkalemia in patients who are not candidates for steroidal mineralocorticoid receptor antagonists due to advanced CKD.,"['patients who are not candidates for steroidal mineralocorticoid receptor antagonists due to advanced CKD', 'patients with stage 3B/4 CKD (estimated glomerular filtration rate ≥15 and ≤44 mL/[min·1.73 m 2 ]) and resistant hypertension (trough cuff seated systolic blood pressure ≥140 mm\u2009Hg, despite treatment with maximally tolerated doses of 2 or more antihypertensive medicines with complementary mechanisms', 'Patients (n=240', 'Advanced Chronic Kidney Disease', 'patients with moderate-to-severe CKD', 'patients with advanced chronic kidney disease (CKD']","['KBP-5074', 'Spironolactone', 'KBP-5074 0.25 mg, KBP-5074 0.5 mg, or placebo', 'Mineralocorticoid Receptor Antagonists', 'placebo']","['blood pressure', 'urinary albumin-creatinine ratio', 'systolic blood pressure', 'glomerular filtration rate', 'trough cuff seated systolic blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0745130', 'cui_str': 'Resistant hypertensive disorder'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0082584', 'cui_str': 'FK-506-Binding Protein'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0486293', 'cui_str': 'Albumin/creatinine ratio measurement'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}]",240.0,0.422527,BLOCK-CKD will determine whether the addition of KBP-5074 will effectively lower blood pressure without an increased risk of hyperkalemia in patients who are not candidates for steroidal mineralocorticoid receptor antagonists due to advanced CKD.,"[{'ForeName': 'George', 'Initials': 'G', 'LastName': 'Bakris', 'Affiliation': 'From the Department of Medicine, American Heart Association Comprehensive Hypertension Center, The University of Chicago Medicine, IL (G.B.).'}, {'ForeName': 'Y Fred', 'Initials': 'YF', 'LastName': 'Yang', 'Affiliation': 'KBP Biosciences, Princeton, NJ (Y.F.Y.).'}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': 'Department of Medicine, University of Michigan School of Medicine, Ann Arbor (B.P.).'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.15199'] 626,32538682,Modified transperitoneal versus retroperitoneal laparoscopic radical nephroureterectomy in the management of upper urinary tract urothelial carcinoma: Best practice in a single center with updated results.,"OBJECTIVE Radical nephroureterectomy remains the gold standard for the surgical treatment of upper urinary tract urothelial carcinoma (UTUC). Based on previous research, we prospectively compared the advantages of transperitoneal laparoscopic radical nephroureterectomy (TLNU) with a three-port technique in a single position versus retroperitoneal laparoscopic radical nephroureterectomy (RLNU). METHODS We evaluated 48 patients diagnosed with UTUC at our institution from January 2015 to October 2019. The patients underwent either TLNU (n = 24) or RLNU (n = 24). We randomly assigned the patients to each technique group based on their body mass index because our experience has shown that the body mass index is the main interfering factor for this surgery. The baseline characteristics and perioperative outcomes were compared between the groups. RESULTS We found no significant differences in the baseline characteristics, time until recovery of intestinal function, or postoperative hospital stay between the two groups. However, the TLNU group had a shorter operation time and better postoperative pain control than the RLNU group. CONCLUSION Modified TLNU is associated with a shorter operative time and less severe postoperative pain compared with RLNU. Both techniques are safe and reliable with adequate management, and their therapeutic effects are comparable in other aspects.",2020,"We found no significant differences in the baseline characteristics, time until recovery of intestinal function, or postoperative hospital stay between the two groups.","['48 patients diagnosed with UTUC at our institution from January 2015 to October 2019', 'upper urinary tract urothelial carcinoma', 'upper urinary tract urothelial carcinoma (UTUC']","['Radical nephroureterectomy', 'Modified TLNU', 'transperitoneal laparoscopic radical nephroureterectomy (TLNU', 'Modified transperitoneal versus retroperitoneal laparoscopic radical nephroureterectomy', 'retroperitoneal laparoscopic radical nephroureterectomy (RLNU', 'TLNU', 'RLNU']","['severe postoperative pain', 'shorter operation time and better postoperative pain control', 'baseline characteristics, time until recovery of intestinal function, or postoperative hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1508753', 'cui_str': 'Urinary system structure'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}, {'cui': 'C1282910', 'cui_str': 'Upper'}]","[{'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0027732', 'cui_str': 'Nephroureterectomy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205501', 'cui_str': 'Transperitoneal approach'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0035359', 'cui_str': 'Retroperitoneal'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",48.0,0.042489,"We found no significant differences in the baseline characteristics, time until recovery of intestinal function, or postoperative hospital stay between the two groups.","[{'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Ye', 'Affiliation': 'Department of Urology, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Zhong', 'Affiliation': 'Department of Urology, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Department of Urology, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Jiannan', 'Initials': 'J', 'LastName': 'Ren', 'Affiliation': 'Department of Urology, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Xiao', 'Affiliation': 'Department of Urology, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xiong', 'Affiliation': 'Department of Urology, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}]",The Journal of international medical research,['10.1177/0300060520928788'] 627,32534724,The Effectiveness of a Time Management Workshop on Job Stress of Nurses Working in Emergency Departments: An Experimental Study.,"INTRODUCTION One of the main risk factors for poor health is a high level of job stress. Time management skills can greatly reduce job stress. The current study aimed to evaluate the effectiveness of a one-time management training workshop on job stress among nurses working in emergency departments. METHODS This randomized experimental study was carried out with 80 nurses working in emergency departments affiliated with a university of medical sciences. The intervention was an 8-hour workshop on time management. Pre- and posttest data were collected by demographic questionnaire and an occupational stress inventory before and 1 month after intervention. Data were analyzed using descriptive, chi-square, t test, Fisher exact, and analysis of covariance statistics. RESULTS The mean of job stress in the intervention group increased after the intervention (186.22, SD = 22.97) from baseline (182.52, SD = 34.39) compared with the mean of job stress in the control group (204.42, SD = 22.42) and (204.35, SD = 22.45). The control group had a significantly higher job stress score before the intervention (t = -3.37, P = 0.001). There was no statistically significant difference between the intervention and control group in job stress scores after intervention (t = -3.56, P = 0.77). DISCUSSION The time management skills training program did not reduce the moderate-high levels of job stress of nurses in emergency departments. Addressing other sources of job stress, besides time management, is needed.",2020,"There was no statistically significant difference between the intervention and control group in job stress scores after intervention (t = -3.56, P = 0.77). ","['80 nurses working in emergency departments affiliated with a university of medical sciences', 'nurses working in emergency departments', 'Job Stress of Nurses Working in Emergency Departments']","['one-time management training workshop', 'Time Management Workshop']","['job stress score', 'job stress scores', 'job stress', 'mean of job stress', 'moderate-high levels of job stress']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}]","[{'cui': 'C0556514', 'cui_str': 'Time management training'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0206209', 'cui_str': 'Time Management'}]","[{'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",80.0,0.0212648,"There was no statistically significant difference between the intervention and control group in job stress scores after intervention (t = -3.56, P = 0.77). ","[{'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Karbakhsh Ravari', 'Affiliation': ''}, {'ForeName': 'Jamileh', 'Initials': 'J', 'LastName': 'Farokhzadian', 'Affiliation': ''}, {'ForeName': 'Monirsadat', 'Initials': 'M', 'LastName': 'Nematollahi', 'Affiliation': ''}, {'ForeName': 'Sakineh', 'Initials': 'S', 'LastName': 'Miri', 'Affiliation': ''}, {'ForeName': 'Golnaz', 'Initials': 'G', 'LastName': 'Foroughameri', 'Affiliation': ''}]",Journal of emergency nursing,['10.1016/j.jen.2020.03.013'] 628,32556606,"Magnetic Tracking and Electrocardiography-Guided Tip Confirmation System Versus Fluoroscopy for Placement of Peripherally Inserted Central Catheters: A Randomized, Noninferiority Comparison.","PURPOSE To determine whether the use of a magnetic tracking and electrocardiography-guided catheter tip confirmation system (TCS) is safe and noninferior to fluoroscopy concerning positioning accuracy of a peripheral inserted central catheter (PICC). METHODS In this prospective, randomized, single-center study, adult patients scheduled for PICC insertion were assigned 1:1 either to TCS or fluoroscopy. The primary objective was a noninferiority comparison of correct PICC tip position confirmed by X-ray obtained immediately after catheter insertion. Time needed for PICC insertion and insertion-related complications up to 14 days after the procedure were secondary outcomes to be assessed for superiority. RESULTS A total of 210 patients (62.3 ± 14.4 years, 63.8% male) were included at a single German center between June 2016 and October 2017. Correct PICC tip position was achieved in 84 of 103 TCS (82.4%) and 103 of 104 fluoroscopy patients (99.0%). One-sided 95% lower confidence limit on the difference between proportions was -23.1%. Thus, noninferiority of TCS was not established (p > 0.99). Insertion of PICC took longer with TCS compared to fluoroscopy (8.4 ± 3.7 min vs. 5.0 ± 2.7 min, p < 0.001). Incidence of complications within a mean follow-up of 5.0 ± 2.3 days did not differ significantly between groups. CONCLUSION Noninferiority of TCS to fluoroscopy in the incidence of correct PICC tip position was not reached. Ancillary benefit of TCS over fluoroscopy including less radiation exposure and lower resource requirements may nonetheless justify the use of TCS. The study is registered with Clinical.Trials.gov (Identifier: NCT02929368).",2020,"CONCLUSION Noninferiority of TCS to fluoroscopy in the incidence of correct PICC tip position was not reached.","['210 patients (62.3\u2009±\u200914.4\xa0years, 63.8% male) were included at a single German center between June 2016 and October 2017', 'adult patients scheduled for PICC insertion']","['Magnetic Tracking and Electrocardiography-Guided Tip Confirmation System', 'TCS or fluoroscopy', 'TCS', 'magnetic tracking and electrocardiography-guided catheter tip confirmation system (TCS', 'Inserted Central Catheters']","['Time needed for PICC insertion and insertion-related complications', 'Correct PICC tip position', 'Incidence of complications']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}]","[{'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0521091', 'cui_str': 'Confirmation of'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0221799', 'cui_str': 'Intravascular guiding catheter'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0444299', 'cui_str': 'Catheter tip'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",210.0,0.174291,"CONCLUSION Noninferiority of TCS to fluoroscopy in the incidence of correct PICC tip position was not reached.","[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Mack', 'Affiliation': 'Department of Radiology, Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Nißler', 'Affiliation': 'Department of Radiology, Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kasikci', 'Affiliation': 'Department of Radiology, Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Malouhi', 'Affiliation': 'Department of Radiology, Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Aschenbach', 'Affiliation': 'Department of Radiology, Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Teichgräber', 'Affiliation': 'Department of Radiology, Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany. ulf.teichgraeber@med.uni-jena.de.'}]",Cardiovascular and interventional radiology,['10.1007/s00270-020-02551-0'] 629,32573054,Acute effects of a very low nicotine content cigarette on laboratory smoking lapse: Impacts of nicotine metabolism and nicotine dependence.,"Reducing cigarette nicotine content to nonaddictive levels facilitates smoking cessation; however, very low nicotine content cigarettes (VLNCs) may not be equally effective across heterogeneous smokers. We evaluated the impact of acute VLNC smoking versus control (sham puffs) on craving, withdrawal and smoking lapse behaviour and whether genetically influenced differences in nicotine metabolism and individual differences in nicotine dependence moderate observed effects. Thirty-three overnight-abstinent smokers (15 slow vs. 17 normal nicotine metabolizers; 17 low vs. 16 high nicotine dependence) smoked a 0.05-mg nicotine VLNC during one session and took sham VLNC puffs during another session, in a counterbalanced order. Craving and withdrawal were assessed before and after smoking and sham puffing. Next, participants completed the McKee Smoking Lapse Task, which measures ability to resist smoking and quantity of ad libitum smoking. VLNC (vs. sham) reduced craving and withdrawal, increased ability to resist smoking and reduced ad libitum smoking. VLNC-induced reduction in craving for positive reinforcement was greater in slow (vs. normal) metabolizers. Nicotine metabolism did not moderate any other VLNC responses. High-dependence (vs. low-dependence) participants engaged in greater ad lib smoking across VLNC and sham conditions. Nicotine dependence did not moderate VLNC responses. VLNC reduced craving, withdrawal and smoking lapse behaviour. Individual differences in nicotine metabolism and dependence had a minimal impact on VLNC responses; however, VLNCs were less effective at reducing craving for positive reinforcement among normal (vs. slow) metabolizers. These findings suggest that desirable VLNC effects may extend across heterogeneous groups of smokers.",2021,"VLNC (vs. sham) reduced craving and withdrawal, increased ability to resist smoking and reduced ad libitum smoking.",['Thirty-three overnight-abstinent smokers (15 slow vs. 17 normal nicotine metabolizers; 17 low vs. 16 high nicotine dependence) smoked a 0.05-mg'],"['nicotine VLNC', 'VLNC', 'low nicotine content cigarette']","['laboratory smoking lapse', 'craving, withdrawal and smoking lapse behaviour', 'craving and withdrawal, increased ability to resist smoking and reduced ad libitum smoking', 'McKee Smoking Lapse Task, which measures ability to resist smoking and quantity of ad libitum smoking', 'Craving and withdrawal', 'Nicotine metabolism', 'craving for positive reinforcement', 'VLNC reduced craving, withdrawal and smoking lapse behaviour']","[{'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028043', 'cui_str': 'Nicotine dependence'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C4517411', 'cui_str': '0.05'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0032741', 'cui_str': 'Positive reinforcement'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",,0.0256903,"VLNC (vs. sham) reduced craving and withdrawal, increased ability to resist smoking and reduced ad libitum smoking.","[{'ForeName': 'Hera E', 'Initials': 'HE', 'LastName': 'Schlagintweit', 'Affiliation': 'Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Rachel F', 'Initials': 'RF', 'LastName': 'Tyndale', 'Affiliation': 'Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Hendershot', 'Affiliation': 'Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}]",Addiction biology,['10.1111/adb.12930'] 630,32573927,Exenatide extended release in patients with type 1 diabetes with and without residual insulin production.,"AIMS To test whether a long-acting GLP-1 receptor agonist would improve glucose control in patients with type 1 diabetes (T1D) and to determine whether the presence of residual beta cell function would affect the response. In addition, we sought to determine whether the drug would affect beta cell function. METHODS We performed a randomized placebo-controlled trial of exenatide extended release (ER) in participants with T1D with and without detectable levels of C-peptide. Seventy-nine participants were randomized to exenatide ER 2 mcg weekly, or placebo, stratified by the presence or absence of detectable C-peptide levels. The primary outcome was the difference in glycated haemoglobin (HbA1c) levels at 24 weeks. Participants were followed for another 6 months off study drug. RESULTS At week 24, the time of the primary outcome, the least squares (LS) mean HbA1c level was 7.76% (95% confidence interval [CI] 7.42, 8.10) in the exenatide ER group versus 8.0% (95% CI 7.64, 8.35) in the placebo group (P = 0.08). At week 12 the LS mean HbA1c levels were 7.71% (95% CI 7.37, 8.05) in the exenatide ER group versus 8.05% (95% CI 7.7, 8.4) in the placebo group (P = 0.01). The improvement at week 12 was driven mainly by those with detectable levels of C-peptide. Those treated with exenatide ER lost weight at 12 and 24 weeks compared to those treated with placebo (P <0.001 and P = 0.007). The total insulin dose was lower, but not when corrected for body weight, and was not affected by residual insulin production. Adverse events were more frequent with exenatide ER, but hypoglycaemia was not increased. CONCLUSION Treatment with exenatide ER may have short-term benefits in some individuals with T1D who are overweight or who have detectable levels of C-peptide, but short-term improvements were not sustained.",2020,Those treated with exenatide ER lost weight at 12 and 24 weeks compared to placebo (p < 0.001 and p = 0.007).,"['patients with Type 1 diabetes (T1D', 'participants with T1D with and without detectable levels of C-peptide', 'Seventy-nine participants', 'patients with Type 1 diabetes with and without residual insulin production']","['exenatide ER 2 mcg weekly or placebo', 'Exenatide ER', 'Glucagon-like peptide-1 receptor agonists (GLP1RA', 'exenatide ER', 'placebo']","['Adverse events', 'hypoglycemia', 'HbA1c level', 'total dose of insulin', 'HbA1c levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]",79.0,0.485484,Those treated with exenatide ER lost weight at 12 and 24 weeks compared to placebo (p < 0.001 and p = 0.007).,"[{'ForeName': 'Kevan C', 'Initials': 'KC', 'LastName': 'Herold', 'Affiliation': 'Departments of Immunobiology, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Reynolds', 'Affiliation': 'Biostatics, Yale University, New Haven, Connecticut.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dziura', 'Affiliation': 'Internal Medicine (Endocrinology), Yale University, New Haven, Connecticut.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Baidal', 'Affiliation': 'Department of Medicine (Endocrinology), University of Miami, Miami, Florida.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Gaglia', 'Affiliation': 'Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Gitelman', 'Affiliation': 'Department of Pediatrics (Endocrinology), University of California, San Francisco, California.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Gottlieb', 'Affiliation': 'Barbara Davis Diabetes Center, University of Colorado, Anschutz, Colorado.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Marks', 'Affiliation': 'Department of Medicine (Endocrinology), University of Miami, Miami, Florida.'}, {'ForeName': 'Louis H', 'Initials': 'LH', 'LastName': 'Philipson', 'Affiliation': 'Department of Medicine (Endocrinology), The University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Rodica', 'Initials': 'R', 'LastName': 'Pop-Busui', 'Affiliation': 'Department of Medicine (Endocrinology), The University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Ruth S', 'Initials': 'RS', 'LastName': 'Weinstock', 'Affiliation': 'Department of Medicine (Endocrinology), SUNY Upstate Medical University, Syracuse, New York.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14121'] 631,32574761,HAWK and HARRIER: Ninety-Six-Week Outcomes from the Phase 3 Trials of Brolucizumab for Neovascular Age-Related Macular Degeneration.,"PURPOSE To report the 96-week outcomes from HAWK and HARRIER. DESIGN Phase 3, prospective, randomized, double-masked, multicenter studies comparing efficacy and safety of brolucizumab 3 mg (HAWK only) and 6 mg with aflibercept 2 mg in eyes with neovascular age-related macular degeneration (nAMD). PARTICIPANTS Treatment-naïve eyes with nAMD were randomized 1:1:1 to brolucizumab 3 mg (n = 358), brolucizumab 6 mg (n = 360), aflibercept 2 mg (n = 360; HAWK) or 1:1 to brolucizumab 6 mg (n = 370), aflibercept 2 mg (n = 369; HARRIER). METHODS After 3 monthly loading doses, brolucizumab patients received every (q)-12-week (w) dosing, possibly adjusting to q8w dosing if disease activity was present at predefined disease activity assessment (DAA) visits. Aflibercept was dosed in a fixed q8w regimen. Visual and anatomic parameters were assessed throughout. Primary end point was at week 48 (48w), confirmed at 96w. MAIN OUTCOME MEASURES Mean best-corrected visual acuity (BCVA) change from baseline, proportion of patients on an q12w regimen, retinal thickness, retinal fluid changes, and safety, all to 96w. RESULTS Mean change (least squares [LS] mean ± standard error) in BCVA from baseline to 96w in HAWK was 5.6±0.79 Early Treatment Diabetic Retinopathy Study (ETDRS) letters for brolucizumab 3 mg, 5.90±0.78 letters for brolucizumab 6 mg, and 5.3±0.78 letters for aflibercept and in HARRIER was 6.1±0.73 letters for brolucizumab 6 mg and 6.6 ± 0.73 letters for aflibercept. Greater central subfield thickness reductions were observed with brolucizumab 6 mg versus aflibercept in HAWK (LS mean, -174.8 μm vs. -148.7 μm; 95% confidence interval for treatment difference, -46.2 to -5.9 μm; P = 0.0115) and HARRIER (LS mean, -197.7 μm vs. -155.1 μm; 95% confidence interval for treatment difference, -62.0 to -23.3 μm; P < 0.0001). The proportions of eyes with intraretinal fluid and/or subretinal fluid (IRF/SRF) at 96w in HAWK were 31% (P = 0.0688) and 24% (P = 0.0002) for brolucizumab 3 mg and 6 mg and 37% for aflibercept, whereas in HARRIER, they were 24% for brolucizumab 6 mg (P < 0.0001) and 39% for aflibercept. At 92w (last DAA), a 45.4% and 38.6% probability was observed for brolucizumab 6 mg patients of maintaining an q12w treatment regimen in HAWK and HARRIER, respectively. Brolucizumab exhibited an overall well-tolerated safety profile. CONCLUSIONS Visual outcomes from 48w to 96w confirm the efficacy achieved at 48w. Brolucizumab demonstrated greater fluid resolution compared with aflibercept. The q12w potential for brolucizumab observed at 48w was maintained to 96w.",2021,"Greater central subfield thickness (CST) reductions were observed with brolucizumab 6mg vs aflibercept in HAWK (LS mean; -174.8 vs -148.7 μm; 95% CI for treatment difference -46.2, -5.9; p=0.0115) and HARRIER (LS mean; -197.7 vs -155.1 μm; 95% CI for treatment difference, -62.0, -23.3; p<0.0001).","['neovascular age-related macular degeneration', 'eyes with neovascular AMD (nAMD) PARTICIPANTS: Treatment naive eyes with nAMD']","['brolucizumab 3mg', 'aflibercept', 'Aflibercept', 'brolucizumab', 'brolucizumab 6mg (n=370) or aflibercept 2mg (n=369) [HARRIER', 'HAWK and HARRIER', 'Brolucizumab', 'brolucizumab 6mg (n=360) or aflibercept 2mg (n=360) [HAWK']","['Visual and anatomical parameters', 'proportion of eyes with intraretinal fluid and/or subretinal fluid (IRF/SRF', 'Mean change (LS mean ±SE) in BCVA (ETDRS letters', 'efficacy and safety', 'overall well-tolerated safety profile', 'Greater central subfield thickness (CST) reductions', 'Mean best corrected visual acuity (BCVA) change from baseline, proportion of patients on q12w, retinal thickness, retinal fluid changes, and safety', 'fluid resolution']","[{'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0017921', 'cui_str': 'Generalized glycogenosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4550124', 'cui_str': 'brolucizumab'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0324380', 'cui_str': 'Harrier dog'}, {'cui': 'C0325553', 'cui_str': 'Hawk'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C4531067', 'cui_str': 'Intraretinal fluid'}, {'cui': 'C1720732', 'cui_str': 'Subretinal fluid'}, {'cui': 'C0063613', 'cui_str': 'insulin resistance factor (uremia)'}, {'cui': 'C0037668', 'cui_str': 'Somatotropin releasing factor'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}]",,0.0754469,"Greater central subfield thickness (CST) reductions were observed with brolucizumab 6mg vs aflibercept in HAWK (LS mean; -174.8 vs -148.7 μm; 95% CI for treatment difference -46.2, -5.9; p=0.0115) and HARRIER (LS mean; -197.7 vs -155.1 μm; 95% CI for treatment difference, -62.0, -23.3; p<0.0001).","[{'ForeName': 'Pravin U', 'Initials': 'PU', 'LastName': 'Dugel', 'Affiliation': 'Retinal Consultants of Arizona, Phoenix, Arizona. Electronic address: pdugel@gmail.com.'}, {'ForeName': 'Rishi P', 'Initials': 'RP', 'LastName': 'Singh', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Koh', 'Affiliation': 'Eye & Retina Surgeons, Singapore, Republic of Singapore.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Ogura', 'Affiliation': 'Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Weissgerber', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Kinfemichael', 'Initials': 'K', 'LastName': 'Gedif', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Jaffe', 'Affiliation': 'Duke Eye Center, Durham, North Carolina.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Tadayoni', 'Affiliation': 'Lariboisiere & Saint Louis Hospitals, Universite de Paris, Paris, France.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Schmidt-Erfurth', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Frank G', 'Initials': 'FG', 'LastName': 'Holz', 'Affiliation': 'University of Bonn, Bonn, Germany.'}]",Ophthalmology,['10.1016/j.ophtha.2020.06.028'] 632,32576049,MENSTRUAL DISORDERS AND ANDROGEN-RELATED TRAITS IN YOUNG WOMEN WITH TYPE 1 DIABETES MELLITUS: A CLINICAL STUDY.,"Objective. To investigate possible causes of menstrual disorders and androgen-related traits in young women with T1DM. Patients and Methods. Fifty-three women with T1DM (duration 8.0±5.6 years), 41 women with PCOS and 51 controls matched for age (19.4±4.3 vs. 21.2±2.7 vs. 20.8±3.1 years, p>0.05) and BMI (22.2±2.7 vs. 21.9±2.0 vs. 21.4±1.9 kg/m2, p>0.05) were prospectively recruited. Results. Two women (3.8%) in the T1DM group had not experienced menarche (at 15.5 and 16.6 years); of the rest, 23.5% had oligomenorrhea, 32.1% hirsutism, 45.3% acne. The age at menarche was delayed in the T1DM group compared to controls (12.7±1.3 vs. 12.0±1.0 years, p=0.004), while no difference was observed with the PCOS group (12.4±1.2 years). There were no differences in total testosterone (0.43±0.14 vs. 0.39±0.14 ng/ml, p>0.05), DHEA-S (269±112 vs. 238±106 μg/dl, p>0.05) or Δ4-androstenedione (2.4±1.3 vs. 1.9±0.5 ng/ml, p>0.05) concentrations between T1DM and controls. However, patients with T1DM had lower SHBG concentrations than controls (61±17 vs. 83±18.1 nmol/l, p=0.001), which were even lower in the PCOS group (39.5±12.9 nmol/, p=0.001 compared with T1DM). FAI (free androgen index) was higher in the PCOS group compared with both other groups (T1DM vs. PCOS vs. controls: 2.53±0.54 vs 7.88±1.21 vs. 1.6±0.68, p<0.001). FAI was higher in patients with T1DM compared to controls, too (p=0.038). There was no difference in DHEA-S concentrations between T1DM and PCOS patients (269±112 vs. 297±100 μg/dl, p>0.05). Conclusions. Menstrual disorders and androgen-related traits in young women with T1DM may be attributed to an increase in androgen bioavailability due to decreased SHBG concentrations.",2020,"FAI was higher in patients with T1DM compared to controls, too (p=0.038).","['TRAITS IN YOUNG WOMEN WITH TYPE 1 DIABETES MELLITUS', 'Fifty-three women with T1DM (duration 8.0±5.6 years), 41 women with PCOS and 51 controls matched for age (19.4±4.3 vs. 21.2±2.7 vs. 20.8±3.1 years, p>0.05) and BMI (22.2±2.7 vs. 21.9±2.0 vs. 21.4±1.9 kg/m2, p>0.05) were prospectively recruited', 'young women with T1DM']",[],"['lower SHBG concentrations', 'FAI (free androgen index', 'total testosterone', 'DHEA-S concentrations', 'FAI']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0428629', 'cui_str': 'Free androgen index measurement'}, {'cui': 'C0202227', 'cui_str': 'Testosterone measurement, total'}, {'cui': 'C0057277', 'cui_str': 'Dehydroepiandrosterone sulfate'}]",53.0,0.0903609,"FAI was higher in patients with T1DM compared to controls, too (p=0.038).","[{'ForeName': 'Stavroula A', 'Initials': 'SA', 'LastName': 'Paschou', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, First Department of Pediatrics and University Research Institute on Maternal and Child Health and Precision Medicine, ""Aghia Sophia"" Children\'s Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Andromachi', 'Initials': 'A', 'LastName': 'Vryonidou', 'Affiliation': 'Department of Diabetes and Endocrinology, Hellenic Red Cross Hospital, Athens, Greece.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Melissourgou', 'Affiliation': 'Department of Diabetes and Endocrinology, Hellenic Red Cross Hospital, Athens, Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Kosteria', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, First Department of Pediatrics and University Research Institute on Maternal and Child Health and Precision Medicine, ""Aghia Sophia"" Children\'s Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Dimitrios G', 'Initials': 'DG', 'LastName': 'Goulis', 'Affiliation': 'Unit of Reproductive Endocrinology, First Department of Obstetrics and Gynecology, Medical School, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'George P', 'Initials': 'GP', 'LastName': 'Chrousos', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, First Department of Pediatrics and University Research Institute on Maternal and Child Health and Precision Medicine, ""Aghia Sophia"" Children\'s Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Kanaka-Gantenbein', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, First Department of Pediatrics and University Research Institute on Maternal and Child Health and Precision Medicine, ""Aghia Sophia"" Children\'s Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}]",Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists,['10.4158/EP-2020-0153'] 633,32579483,Protective effect of dexmedetomidine infusion combined with epidural blockade on postoperative complications after surgery: A prospective randomized controlled clinical trial.,"OBJECTIVES This prospective, randomized, controlled study aimed to explore the efficacy of dexmedetomidine combined with epidural blockade on postoperative recovery of elderly patients after radical resection for colorectal cancer. METHODS Ninety-six elderly patients who underwent radical resection for colorectal cancer were randomly divided into the following four groups: dexmedetomidine, epidural blockade (ropivacaine), combined (dexmedetomidine + epidural blockade), and control (0.9% saline). The Mini-Mental State Examination (MMSE), Visual Analog Scale (VAS), and Ramsay scores at 48 hours, and time to first activity, length of hospital stay, and postoperative complication rates at 3 months were assessed. RESULTS Twelve hours after surgery, Ramsay scores were higher in the combined compared with the control and epidural blockade groups. Twenty-four hours after surgery, MMSE scores were higher in the combined compared with the other groups. The combined group showed the lowest VAS scores except at 48 hours. Time to first activity and length of hospital stay were significantly shorter in the combined compared with the other groups. There was no difference in total postoperative complication rates among the groups. CONCLUSIONS A combination of intraoperative dexmedetomidine infusion and epidural blockade could mitigate pain after surgery, improve cognitive dysfunction in early surgery, and facilitate recovery.",2020,"There was no difference in total postoperative complication rates among the groups. ","['elderly patients after radical resection for colorectal cancer', 'for colorectal cancer', 'Ninety-six elderly patients who underwent', 'after surgery']","['dexmedetomidine combined with epidural blockade', 'dexmedetomidine, epidural blockade (ropivacaine), combined (dexmedetomidine\u2009+\u2009epidural blockade), and control (0.9% saline', 'dexmedetomidine infusion combined with epidural blockade', 'radical resection', 'intraoperative dexmedetomidine infusion and epidural blockade']","['MMSE scores', 'lowest VAS scores', 'cognitive dysfunction', 'postoperative complications', 'total postoperative complication rates', 'Time to first activity and length of hospital stay', 'Mini-Mental State Examination (MMSE), Visual Analog Scale (VAS), and Ramsay scores at 48 hours, and time to first activity, length of hospital stay, and postoperative complication rates', 'Ramsay scores']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]","[{'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439586', 'cui_str': '48 hours'}]",96.0,0.113406,"There was no difference in total postoperative complication rates among the groups. ","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Xuqin', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': 'Department of Anesthesiology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Zhirong', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhong', 'Affiliation': 'Department of Anesthesiology, Fudan University Shanghai Cancer Center, Shanghai, China.'}]",The Journal of international medical research,['10.1177/0300060520930168'] 634,32495671,Clinical effectiveness of position management and manual rotation of the fetal position with a U-shaped birth stool for vaginal delivery of a fetus in a persistent occiput posterior position.,"OBJECTIVE To examine the effects of position management, manual rotation of the fetal position, and using a U-shaped birth stool in primiparous women with a fetus in a persistent occiput posterior position. METHODS This was a prospective pilot study of women who delivered at Gansu Provincial Maternity and Child-care Hospital between January and June 2018. The women were divided into the position management ([PM] position management, manual rotation of fetal position, use of a U-shaped birth stool at different stages, and routine nursing) and control groups (position selected by women and routine nursing). RESULTS There were 196 women in the PM group and 188 in the control group. There were no significant differences in maternal age, gestational weeks, newborn weight, and the neonatal asphyxia rate between the PM and control groups. The duration of labor was shorter in the PM group than in the control group. Pain and blood loss 2 hours after delivery and the episiotomy rate were significantly lower in the PM group than in the control group. CONCLUSION Applying position management, manual rotation of the fetal position, and using a U-shaped birth stool should be considered for women with a fetus in a persistent occiput posterior position.",2020,"Pain and blood loss 2 hours after delivery and the episiotomy rate were significantly lower in the PM group than in the control group. ","['196 women in the PM group and 188 in the control group', 'women who delivered at Gansu Provincial Maternity and Child-care Hospital between January and June 2018', 'primiparous women with a fetus in a persistent occiput posterior position']","['position management and manual rotation of the fetal position with a U-shaped birth stool', 'position management ([PM] position management, manual rotation of fetal position, use of a U-shaped birth stool at different stages, and routine nursing) and control groups (position selected by women and routine nursing', 'position management, manual rotation of the fetal position, and using a U-shaped birth stool']","['maternal age, gestational weeks, newborn weight, and the neonatal asphyxia rate', 'duration of labor', 'Pain and blood loss 2 hours after delivery and the episiotomy rate']","[{'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008067', 'cui_str': 'Puericulture'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0856256', 'cui_str': 'Occiput posterior'}, {'cui': 'C0733755', 'cui_str': 'Position'}]","[{'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C1286298', 'cui_str': 'Position of fetus'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C1443305', 'cui_str': 'Birthing stool'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0024915', 'cui_str': 'Maternal age'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0004045', 'cui_str': 'Asphyxia, in liveborn infant'}, {'cui': 'C0566679', 'cui_str': 'Duration of labor'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}]",,0.0261708,"Pain and blood loss 2 hours after delivery and the episiotomy rate were significantly lower in the PM group than in the control group. ","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Perinatal Center, Gansu Provincial Maternity and Child-care Hospital, Lanzhou, China.'}, {'ForeName': 'Tongying', 'Initials': 'T', 'LastName': 'Yi', 'Affiliation': 'Delivery Room, Gansu Provincial Maternity and Child-care Hospital, Lanzhou, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': 'Perinatal Center, Gansu Provincial Maternity and Child-care Hospital, Lanzhou, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Ministry of Science and Technology Development, Gansu Provincial Maternity and Child-care Hospital, Lanzhou, China.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Perinatal Center, Gansu Provincial Maternity and Child-care Hospital, Lanzhou, China.'}, {'ForeName': 'Yufang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesia Surgery, Gansu Provincial Maternity and Child-care Hospital, Lanzhou, China.'}, {'ForeName': 'Qingmei', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': 'Prenatal Diagnosis Center, Gansu Provincial Maternity and Child-care Hospital, Lanzhou, China.'}, {'ForeName': 'Xiaojuan', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'Prenatal Diagnosis Center, Gansu Provincial Maternity and Child-care Hospital, Lanzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics, Gansu Provincial Maternity and Child-care Hospital, Lanzhou, China.'}, {'ForeName': 'Zhaoyan', 'Initials': 'Z', 'LastName': 'Meng', 'Affiliation': 'Department of Obstetrics, Gansu Provincial Maternity and Child-care Hospital, Lanzhou, China.'}]",The Journal of international medical research,['10.1177/0300060520924275'] 635,32139550,Substantial and sustained improvement of serrated polyp detection after a simple educational intervention: results from a prospective controlled trial.,"OBJECTIVE Serrated polyps (SPs) are an important cause of postcolonoscopy colorectal cancers (PCCRCs), which is likely the result of suboptimal SP detection during colonoscopy. We assessed the long-term effect of a simple educational intervention focusing on optimising SP detection. DESIGN An educational intervention, consisting of two 45 min training sessions (held 3 years apart) on serrated polyp detection, was given to endoscopists from 9 Dutch hospitals. Hundred randomly selected and untrained endoscopists from other hospitals were selected as control group. Our primary outcome measure was the proximal SP detection rate (PSPDR) in trained versus untrained endoscopists who participated in our faecal immunochemical test (FIT)-based population screening programme. RESULTS Seventeen trained and 100 untrained endoscopists were included, who performed 11 305 and 51 039 colonoscopies, respectively. At baseline, PSPDR was equal between the groups (9.3% vs 9.3%). After training, the PSPDR of trained endoscopists gradually increased to 15.6% in 2018. This was significantly higher than the PSPDR of untrained endoscopists, which remained stable around 10% (p=0.018). All below-average (ie, PSPDR ≤6%) endoscopists at baseline improved their PSPDR after training session 1, as did 57% of endoscopists with average PSPDR (6%-12%) at baseline. The second training session further improved the PSPDR in 44% of endoscopists with average PSPDR after the first training. CONCLUSION A simple educational intervention was associated with substantial long-term improvement of PSPDR in a prospective controlled trial within FIT-based population screening. Widespread implementation of such interventions might be an easy way to improve SP detection, which may ultimately result in fewer PCCRCs. TRIAL REGISTRATION NUMBER NCT03902899.",2020,"The second training session further improved the PSPDR in 44% of endoscopists with average PSPDR after the first training. ","['Seventeen trained and 100 untrained endoscopists were included, who performed 11\u2009305 and 51\u2009039 colonoscopies, respectively', 'Hundred randomly selected and untrained endoscopists from other hospitals were selected as control group']",['simple educational intervention'],"['PSPDR of trained endoscopists', 'proximal SP detection rate (PSPDR', 'PSPDR']","[{'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4517703', 'cui_str': 'Three hundred and five'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}]",0.0,0.0346153,"The second training session further improved the PSPDR in 44% of endoscopists with average PSPDR after the first training. ","[{'ForeName': 'Arne G C', 'Initials': 'AGC', 'LastName': 'Bleijenberg', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Monique E', 'Initials': 'ME', 'LastName': 'van Leerdam', 'Affiliation': 'Department of Gastroenterology and Hepatology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Marloes', 'Initials': 'M', 'LastName': 'Bargeman', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medical Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Jan Jacob', 'Initials': 'JJ', 'LastName': 'Koornstra', 'Affiliation': 'Department of Gastroenterology and Hepatology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Yasmijn J', 'Initials': 'YJ', 'LastName': 'van Herwaarden', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Manon Cw', 'Initials': 'MC', 'LastName': 'Spaander', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Sanduleanu', 'Affiliation': 'Department of Gastroenterology and Hepatology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Barbara A J', 'Initials': 'BAJ', 'LastName': 'Bastiaansen', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Erik J', 'Initials': 'EJ', 'LastName': 'Schoon', 'Affiliation': 'Department of Gastroenterology and Hepatology, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Lelyveld', 'Affiliation': 'Department of Gastroenterology and Hepatology, Saint Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Evelien', 'Initials': 'E', 'LastName': 'Dekker', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands e.dekker@amsterdamumc.nl.'}, {'ForeName': 'Joep E G', 'Initials': 'JEG', 'LastName': 'IJspeert', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}]",Gut,['10.1136/gutjnl-2019-319804'] 636,32515696,"Effect of emergent carotid stenting during endovascular therapy for acute anterior circulation stroke patients with tandem occlusion: A multicenter, randomized, clinical trial (TITAN) protocol.","BACKGROUND AND HYPOTHESIS There is no consensus on the optimal endovascular management of the extracranial internal carotid artery steno-occlusive lesion in patients with acute ischemic stroke due to tandem occlusion. We hypothesized that intracranial mechanical thrombectomy plus emergent internal carotid artery stenting (and at least one antiplatelet therapy) is superior to intracranial mechanical thrombectomy alone in patients with acute tandem occlusion. STUDY DESIGN TITAN is an investigator-initiated, multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) study. Eligibility requires a diagnosis of acute ischemic stroke, pre-stroke modified Rankin Scale (mRS)≤2 (no upper age limit), National Institutes of Health Stroke Scale (NIHSS)≥6, Alberta Stroke Program Early Computed Tomography Score (ASPECTS)≥6, and tandem occlusion on the initial catheter angiogram. Tandem occlusion is defined as large vessel occlusion (intracranial internal carotid artery , M1 and/or M2 segment) and extracranial severe internal carotid artery stenosis ≥90% (NASCET) or complete occlusion. Patients are randomized in two balanced parallel groups (1:1) to receive either intracranial mechanical thrombectomy plus internal carotid artery stenting (and at least one antiplatelet therapy) or intracranial mechanical thrombectomy alone within 8 h of stroke onset. Up to 432 patients are randomized after tandem occlusion confirmation on angiogram. STUDY OUTCOMES The primary outcome measure is complete reperfusion rate at the end of endovascular procedure, assessed as a modified Thrombolysis in Cerebral Infarction (mTICI) 3, and ≥4 point decrease in NIHSS at 24 h. Secondary outcomes include infarct growth, recurrent clinical ischemic event in the ipsilateral carotid territory, type and dose of antiplatelet therapy used, mRS at 90 (±15) days and 12 (±1) months. Safety outcomes are procedural complications, stent patency, intracerebral hemorrhage, and death. Economics analysis includes health-related quality of life, and costs utility comparison, especially with the need or not of endarterectomy. DISCUSSION TITAN is the first randomized trial directly comparing two types of treatment in patients with acute ischemic stroke due to anterior circulation tandem occlusion, and especially assessing the safety and efficacy of emergent internal carotid artery stenting associated with at least one antiplatelet therapy in the acute phase of stroke reperfusion. TRIAL REGISTRATION ClinicalTrials.gov NCT03978988.",2021,"Tandem occlusion is defined as large vessel occlusion (intracranial internal carotid artery , M1 and/or M2 segment) and extracranial severe internal carotid artery stenosis ≥90% (NASCET) or complete occlusion.","['432 patients', 'patients with acute ischemic stroke due to anterior circulation tandem occlusion', 'patients with acute tandem occlusion', 'patients with acute ischemic stroke due to tandem occlusion', 'acute anterior circulation stroke patients with tandem occlusion']","['endovascular therapy', 'intracranial mechanical thrombectomy plus emergent internal carotid artery stenting (and at least one antiplatelet therapy', 'intracranial mechanical thrombectomy plus internal carotid artery stenting (and at least one antiplatelet therapy) or intracranial mechanical thrombectomy alone', 'emergent carotid stenting']","['complete reperfusion rate at the end of endovascular procedure, assessed as a modified Thrombolysis in Cerebral Infarction (mTICI) 3, and ≥4 point decrease in NIHSS', 'procedural complications, stent patency, intracerebral hemorrhage, and death', 'infarct growth, recurrent clinical ischemic event in the ipsilateral carotid territory, type and dose of antiplatelet therapy used, mRS at 90 (±15) days and 12 (±1) months']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0007276', 'cui_str': 'Internal carotid artery structure'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0850458', 'cui_str': 'Carotid stent'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C2936204', 'cui_str': 'Intravascular Techniques'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1141861', 'cui_str': 'Procedural complication'}, {'cui': 'C0449591', 'cui_str': 'Stent patency'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",,0.118466,"Tandem occlusion is defined as large vessel occlusion (intracranial internal carotid artery , M1 and/or M2 segment) and extracranial severe internal carotid artery stenosis ≥90% (NASCET) or complete occlusion.","[{'ForeName': 'François', 'Initials': 'F', 'LastName': 'Zhu', 'Affiliation': 'Department of Diagnostic and Therapeutic Neuroradiology, Université de Lorraine, Nancy University Hospital, Nancy, France.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Hossu', 'Affiliation': 'CIC 1433, Technological Innovation, IADI, INSERM U1254, Nancy University Hospital, Université de Lorraine, Nancy, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Soudant', 'Affiliation': 'CIC 1433 Clinical Epidemiology, Nancy University Hospital, Université de Lorraine, Nancy, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Richard', 'Affiliation': 'CIC 1433 Plurithematic, Nancy University Hospital, Université de Lorraine, Nancy, France.'}, {'ForeName': 'Hamza', 'Initials': 'H', 'LastName': 'Achit', 'Affiliation': 'CIC 1433 Clinical Epidemiology, Nancy University Hospital, Université de Lorraine, Nancy, France.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Beguinet', 'Affiliation': 'CIC 1433 Clinical Epidemiology, Nancy University Hospital, Université de Lorraine, Nancy, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Costalat', 'Affiliation': 'Department of Interventional Neuroradiology, CHRU Gui de Chauliac, Montpellier, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Arquizan', 'Affiliation': 'Department of Neurology, CHRU Gui de Chauliac, Montpellier, France.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Consoli', 'Affiliation': 'Department of Diagnostic and Interventional Neuroradiology, Foch Hospital, Versailles Saint-Quentin en Yvelines University, Suresnes, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Lapergue', 'Affiliation': 'Department of Neurology, Foch Hospital, Versailles Saint-Quentin en Yvelines University, Suresnes, France.'}, {'ForeName': 'Aymeric', 'Initials': 'A', 'LastName': 'Rouchaud', 'Affiliation': 'Department of Interventional Neuroradiology, CHU Dupuytren, Limoges, France.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Macian-Montoro', 'Affiliation': 'Department of Neurology, CHU Dupuytren, Limoges, France.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Biondi', 'Affiliation': 'Department of Neuroradiology and Endovascular Therapy, Besançon University Hospital, Besancon, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Moulin', 'Affiliation': 'Department of Neurology, Besançon University Hospital, Besancon, France.'}, {'ForeName': 'Gaultier', 'Initials': 'G', 'LastName': 'Marnat', 'Affiliation': 'Department of Neuroradiology, University Hospital of Bordeaux, Bordeaux, France.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Sibon', 'Affiliation': 'Department of Neurology, Stroke Center, University Hospital of Bordeaux, Bordeaux, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Paya', 'Affiliation': 'Department of Neuroradiology, Rennes University Hospital, Rennes, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Vannier', 'Affiliation': 'Department of Neurology, Rennes University Hospital, Rennes, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Cognard', 'Affiliation': 'Department of Neuroradiology, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Viguier', 'Affiliation': 'Department of Neurology, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Mazighi', 'Affiliation': 'Department of Interventional Neuroradiology, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Obadia', 'Affiliation': 'Department of Neurology, Stroke Unit, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'Wagih B', 'Initials': 'WB', 'LastName': 'Hassen', 'Affiliation': 'Department of Neuroradiology, Saint-Anne Hospital, Paris, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Turc', 'Affiliation': 'Department of Neurology, Stroke Unit, Saint-Anne Hospital, Paris, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Clarençon', 'Affiliation': 'Department of Neuroradiology, Pitié-Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Samson', 'Affiliation': 'Department of Neurology, Stroke Unit, Pitié-Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Dumas-Duport', 'Affiliation': 'Department of Neuroradiology, Nantes University Hospital, Nantes, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Preterre', 'Affiliation': 'Department of Neurology, Nantes University Hospital, Nantes, France.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Barbier', 'Affiliation': 'Department of Neuroradiology, Caen University Hospital, Caen, France.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Boulanger', 'Affiliation': 'Department of Neurology, Caen University Hospital, Caen, France.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Janot', 'Affiliation': 'Department of Neuroradiology, Tours University Hospital, Lille, France.'}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Annan', 'Affiliation': 'Department of Neurology, Tours University Hospital, Lille, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bricout', 'Affiliation': 'Department of Neuroradiology, Lille University Hospital, Lille, France.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Henon', 'Affiliation': 'Department of Neurology, Lille University Hospital, Lille, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Soize', 'Affiliation': 'Department of Neuroradiology, Reims University Hospital, Lille, France.'}, {'ForeName': 'Solène', 'Initials': 'S', 'LastName': 'Moulin', 'Affiliation': 'Department of Neurology, Reims University Hospital, Lille, France.'}, {'ForeName': 'Marc-Antoine', 'Initials': 'MA', 'LastName': 'Labeyrie', 'Affiliation': 'Department of Neuroradiology, Lariboisière Hospital, Paris, France.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Reiner', 'Affiliation': 'Department of Neurology, Lariboisière Hospital, Paris, France.'}, {'ForeName': 'Raoul', 'Initials': 'R', 'LastName': 'Pop', 'Affiliation': 'Department of Neuroradiology, Strasbourg University Hospital, Strasbourg, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Wolff', 'Affiliation': 'Department of Neurology, Stroke Unit, Strasbourg University Hospital, Strasbourg, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Ognard', 'Affiliation': 'Department of Neuroradiology, Brest University Hospital, Brest, France.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Timsit', 'Affiliation': 'Department of Neurology, Brest University Hospital, Brest, France.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Reyre', 'Affiliation': 'Department of Neuroradiology, Marseille University Hospital, Marseille, France.'}, {'ForeName': 'Charline', 'Initials': 'C', 'LastName': 'Perot', 'Affiliation': 'Department of Neurology, Marseille University Hospital, Marseille, France.'}, {'ForeName': 'Chrysanthi', 'Initials': 'C', 'LastName': 'Papagiannaki', 'Affiliation': 'Department of Neuroradiology, Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Triquenot-Bagan', 'Affiliation': 'Department of Neurology, Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Bracard', 'Affiliation': 'Department of Diagnostic and Therapeutic Neuroradiology, Université de Lorraine, Nancy University Hospital, Nancy, France.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Anxionnat', 'Affiliation': 'Department of Diagnostic and Therapeutic Neuroradiology, Université de Lorraine, Nancy University Hospital, Nancy, France.'}, {'ForeName': 'Anne-Laure', 'Initials': 'AL', 'LastName': 'Derelle', 'Affiliation': 'Department of Diagnostic and Therapeutic Neuroradiology, Université de Lorraine, Nancy University Hospital, Nancy, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Tonnelet', 'Affiliation': 'Department of Diagnostic and Therapeutic Neuroradiology, Université de Lorraine, Nancy University Hospital, Nancy, France.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Liao', 'Affiliation': 'Department of Diagnostic and Therapeutic Neuroradiology, Université de Lorraine, Nancy University Hospital, Nancy, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Schmitt', 'Affiliation': 'Department of Diagnostic and Therapeutic Neuroradiology, Université de Lorraine, Nancy University Hospital, Nancy, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Planel', 'Affiliation': 'Department of Diagnostic and Therapeutic Neuroradiology, Université de Lorraine, Nancy University Hospital, Nancy, France.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Guillemin', 'Affiliation': 'CIC 1433 Clinical Epidemiology, Nancy University Hospital, Université de Lorraine, Nancy, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Gory', 'Affiliation': 'Department of Diagnostic and Therapeutic Neuroradiology, Université de Lorraine, Nancy University Hospital, Nancy, France.'}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493020929948'] 637,32519569,Randomised clinical study of the impact of routine preoperative Doppler ultrasound for the outcome of autologous arteriovenous fistulas for haemodialysis.,"BACKGROUND Arteriovenous fistulas are the gold standard of vascular accesses in haemodialysis; however, they have a considerable primary failure rate. This study evaluated the comparative reliability of routine preoperative Doppler ultrasound with an isolated physical examination of autologous arteriovenous fistulas within the Single Health System of Brazil and analysed the potential clinical benefit, improvement in primary failure rates and its economic impact. METHODS A non-blind randomised clinical study group of patients undergoing a vessel mapping with preoperative Doppler ultrasound (ultrasound group) and a control group who had undergone only a physical examination (clinical group) before the vascular procedures was performed. The role of the arteriovenous fistula in dialysis and possible alterations was evaluated in both the groups and followed up for 6 months. RESULTS Of the initial 248 eligible patients, there was a randomisation of 230 patients, 228 of whom were submitted for surgery, 114 in each group. In the clinical group, a significantly higher rate of primary failure was recorded, with 13.6% versus 4.4% in the ultrasound group ( p = 0.002). The Kaplan-Meier curve with log-rank analysis showed a significantly higher primary patency in the ultrasound group ( p = 0.042). Regarding the cost-effectiveness of the use of Doppler ultrasound, there was no increase in the final cost compared to the physical examination (US$1.28/fistula day × US$1.29/fistula day). CONCLUSION It was concluded that Doppler ultrasound contributed to the reduction of primary failure, leading to a significantly superior primary patency of arteriovenous fistulas, and no increase in the final cost. This justifies its routine preoperative use in the Single Health System. Registration number RBR-474xhn (http://www.ensaiosclinicos.gov.br).",2021,The Kaplan-Meier curve with log-rank analysis showed a significantly higher primary patency in the ultrasound group ( p = 0.042).,"['230 patients, 228 of whom were submitted for surgery, 114 in each group', 'patients undergoing a vessel mapping with preoperative Doppler ultrasound (ultrasound group) and a control group who had undergone only a physical examination (clinical group) before the vascular procedures was performed', 'autologous arteriovenous fistulas for haemodialysis', '248 eligible patients']","['routine preoperative Doppler ultrasound', 'Doppler ultrasound', 'routine preoperative Doppler ultrasound with an isolated physical examination of autologous arteriovenous fistulas']","['Registration number RBR-474xhn ( http://www.ensaiosclinicos.gov.br ', 'final cost', 'primary patency', 'rate of primary failure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0303405', 'cui_str': 'Indium-114'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0162481', 'cui_str': 'Doppler ultrasound'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0162481', 'cui_str': 'Doppler ultrasound'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",,0.0279572,The Kaplan-Meier curve with log-rank analysis showed a significantly higher primary patency in the ultrasound group ( p = 0.042).,"[{'ForeName': 'Jocefábia Reika Alves', 'Initials': 'JRA', 'LastName': 'Lopes', 'Affiliation': 'Department of Vascular Surgery, Centro Universitário Saúde ABC, Santo André, Brazil.'}, {'ForeName': 'Ana Lígia de Barros', 'Initials': 'ALB', 'LastName': 'Marques', 'Affiliation': 'Department of Endocrinology, Federal University of Maranhão, Imperatriz, Brazil.'}, {'ForeName': 'João Antonio', 'Initials': 'JA', 'LastName': 'Correa', 'Affiliation': 'Department of Vascular Surgery, Centro Universitário Saúde ABC, Santo André, Brazil.'}]",The journal of vascular access,['10.1177/1129729820927273'] 638,32525564,Thromboembolic events after high-intensity training during cisplatin-based chemotherapy for testicular cancer: Case reports and review of the literature.,"The randomized ""Testicular cancer and Aerobic and Strength Training trial"" (TAST-trial) aimed to evaluate the effect of high-intensity interval training (HIIT) on cardiorespiratory fitness during cisplatin-based chemotherapy (CBCT) for testicular cancer (TC). Here, we report on an unexpected high number of thromboembolic (TE) events among patients randomized to the intervention arm, and on a review of the literature on TE events in TC patients undergoing CBCT. Patients aged 18 to 60 years with a diagnosis of metastatic germ cell TC, planned for 3 to 4 CBCT cycles, were randomized to a 9 to 12 weeks exercise intervention, or to a single lifestyle counseling session. The exercise intervention included two weekly HIIT sessions, each with 2 to 4 intervals of 2 to 4 minutes at 85% to 95% of peak heart rate. The study was prematurely discontinued after inclusion of 19 of the planned 94 patients, with nine patients randomized to the intervention arm and 10 to the control arm. Three patients in the intervention arm developed TE complications; two with pulmonary embolism and one with myocardial infarction. All three patients had clinical stage IIA TC. No TE complications were observed among patients in the control arm. Our observations indicate that high-intensity aerobic training during CBCT might increase the risk of TE events in TC patients, leading to premature closure of the TAST-trial.",2020,No TE complications were observed among patients in the control arm.,"['Patients aged 18-60\u2009years with a diagnosis of metastatic germ cell TC, planned for 3-4 CBCT cycles', 'testicular cancer (TC', 'testicular cancer', 'TC patients undergoing CBCT']","['cisplatin-based chemotherapy (CBCT', 'exercise intervention, or to a single lifestyle counseling session', 'high-intensity interval training (HIIT', 'cisplatin-based chemotherapy']","['TE complications', 'risk of TE events', 'thromboembolic (TE) events', 'Thromboembolic events', 'cardiorespiratory fitness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0017471', 'cui_str': 'Germ cell'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0153594', 'cui_str': 'Malignant tumor of testis'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}]",9.0,0.0580454,No TE complications were observed among patients in the control arm.,"[{'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Thorsen', 'Affiliation': 'National Advisory Unit on Late Effects after Cancer Treatment, Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Hege S', 'Initials': 'HS', 'LastName': 'Haugnes', 'Affiliation': 'Department of Oncology, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Sophie D', 'Initials': 'SD', 'LastName': 'Fosså', 'Affiliation': 'National Advisory Unit on Late Effects after Cancer Treatment, Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Brydøy', 'Affiliation': 'Department of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Torgrim', 'Initials': 'T', 'LastName': 'Tandstad', 'Affiliation': 'Clinic of Oncology, St. Olavs Hospital, Trondheim, Norway.'}, {'ForeName': 'Torbjørn', 'Initials': 'T', 'LastName': 'Wisløff', 'Affiliation': 'Institute of Clinical Medicine, University of Tromsø - The Arctic University, Tromsø, Norway.'}, {'ForeName': 'Gunhild M', 'Initials': 'GM', 'LastName': 'Gjerset', 'Affiliation': 'National Advisory Unit on Late Effects after Cancer Treatment, Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Edvardsen', 'Affiliation': 'Department of Pulmonary Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Karl-Otto', 'Initials': 'KO', 'LastName': 'Larsen', 'Affiliation': 'Department of Pulmonary Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Per Morten', 'Initials': 'PM', 'LastName': 'Sandset', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Carola E', 'Initials': 'CE', 'LastName': 'Henriksson', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Truls', 'Initials': 'T', 'LastName': 'Raastad', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sports Sciences, Oslo, Norway.'}, {'ForeName': 'Helene F S', 'Initials': 'HFS', 'LastName': 'Negaard', 'Affiliation': 'Department of Oncology, Oslo University Hospital, Oslo, Norway.'}]",International journal of cancer,['10.1002/ijc.33151'] 639,32529884,Acupuncture at LR3 and KI3 shows a control effect on essential hypertension and targeted action on cerebral regions related to blood pressure regulation: a resting state functional magnetic resonance imaging study.,"OBJECTIVE The aim of this study was to investigate the effects of acupuncture at LR3 and KI3 on hypertension at different time points and on related cerebral regions using resting-state functional magnetic resonance imaging (rs-fMRI). METHODS We randomly divided 29 subjects into two groups: Group A (receiving acupuncture at LR3 + KI3; 15 subjects) and group B (receiving acupuncture at LR3 and a sham location not corresponding to any traditional acupuncture point; 14 subjects). Acupuncture was performed. Blood pressure (BP) changes were recorded and analyzed using SPSS 20.0 statistical software. We used a 3.0T MRI scanner and standard GE 8 channel head coil to collect whole brain fMRI data in both groups. Data analysis and processing was based on the R2009a MATLAB platform. REST 1.8 software was used to analyze the whole brain amplitude of low-frequency fluctuation (ALFF). RESULTS After acupuncture, a statistically significant reduction in BP at different time points was observed in group A. In group B, a statistically significant reduction was found only in diastolic blood pressure (DBP) and was not sustained. Acupuncture at LR3 + KI3 specifically affected brain areas involved in BP regulation, as well as those involved in auditory sense, speech, vision, movement and sensation. CONCLUSION Acupuncture at LR3 + KI3 showed positive immediate and long-term effects on BP, particularly systolic blood pressure (SBP). After ALFF analysis, we concluded that LR3 + KI3 activates brain areas related to BP regulation. In addition, after acupuncture at LR3 + KI3, a highly targeted effect was observed in brain areas associated with BP. In addition, extracerebral areas involving vision, motion control, cognition and hearing were activated, which could potentially contribute to the mitigation of hypertensive complications in patients in an advanced stage of the disease.",2021,"After acupuncture, a statistically significant reduction in BP at different time points was observed in group A. In group B, a statistically significant reduction was found only in diastolic blood pressure (DBP) and was not sustained.",[],"['acupuncture', 'acupuncture at LR3\u2009+\u2009KI3; 15 subjects) and group B (receiving acupuncture at LR3 and a sham location not corresponding to any traditional acupuncture', 'Acupuncture']","['positive immediate and long-term effects on BP, particularly systolic blood pressure (SBP', 'BP', 'Blood pressure (BP) changes', 'diastolic blood pressure (DBP']",[],"[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0450768', 'cui_str': 'LR3'}, {'cui': 'C0450663', 'cui_str': 'KI3'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0023983', 'cui_str': 'Effects, Longterm'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",29.0,0.0278318,"After acupuncture, a statistically significant reduction in BP at different time points was observed in group A. In group B, a statistically significant reduction was found only in diastolic blood pressure (DBP) and was not sustained.","[{'ForeName': 'Jiping', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'School of the Tradition Chinese Medicine, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Taibiao', 'Initials': 'T', 'LastName': 'Lyu', 'Affiliation': 'Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yicheng', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yanjie', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Weinan Vocational and Technical College, Weinan, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'School of the Tradition Chinese Medicine, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Qu', 'Affiliation': 'School of the Tradition Chinese Medicine, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Zhinan', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'School of the Tradition Chinese Medicine, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Xiaowen', 'Initials': 'X', 'LastName': 'Cai', 'Affiliation': 'School of the Tradition Chinese Medicine, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Chunzhi', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'Clinical Medical College of Acupuncture and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'School of the Tradition Chinese Medicine, Southern Medical University, Guangzhou, China.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1177/0964528420920282'] 640,32533519,Assessment of the Effect of Perioperative Venous Lidocaine on the Intensity of Pain and IL-6 Concentration After Laparoscopic Gastroplasty.,"BACKGROUND AND OBJECTIVES Opioids are associated with sedation and respiratory depression. The primary objective of this study was to assess pain intensity after gastric bypass with lidocaine. The secondary objective was to assess the IL-6 concentration, consumption of morphine, time to morphine request, time to extubation, and side effects. METHODS Sixty patients aged 18 to 60 years, with ASA (American Society of Anesthesiologists) scores of 2 or 3, who underwent bariatric surgery were allocated to two groups. Patients in group 1 were administered lidocaine (1.5 mg/kg) 5 min before the induction of anesthesia, and group 2 was administered 0.9% saline solution in an equal volume. Subsequently, lidocaine (2 mg/kg/h) or 0.9% saline was infused during the entire surgical procedure. Anesthesia was performed with fentanyl (5 μg/kg), propofol, rocuronium, and sevoflurane. Postoperative patient-controlled analgesia was provided with morphine. The following were evaluated: pain intensity, IL-6, 24-h consumption of morphine, time to the morphine request, time to extubation, and adverse effects. RESULTS The lidocaine group had a lower pain intensity than the saline group for up to 1 h, with no differences between groups in IL-6 and time to extubation. The lidocaine group consumed less morphine within 24 h, had a longer time until the first supplemental morphine request, and had a lower incidence of nausea. CONCLUSIONS Lidocaine reduced the intensity of early postoperative pain, incidence of nausea, and consumption of morphine within 24 h and increased time to the first morphine request, without reducing the plasma concentrations of IL-6.",2020,"The lidocaine group had a lower pain intensity than the saline group for up to 1 h, with no differences between groups in IL-6 and time to extubation.","['Sixty patients aged 18 to 60\xa0years, with ASA (American Society of Anesthesiologists) scores of 2 or 3, who underwent bariatric surgery']","['Lidocaine', 'lidocaine', 'fentanyl', 'propofol, rocuronium, and sevoflurane', 'Perioperative Venous Lidocaine', 'morphine']","['IL-6 concentration, consumption of morphine, time to morphine request, time to extubation, and side effects', 'intensity of early postoperative pain, incidence of nausea, and consumption of morphine', 'pain intensity', 'Intensity of Pain and IL-6 Concentration', 'plasma concentrations of IL-6', 'nausea', 'IL-6 and time to extubation', 'pain intensity, IL-6, 24-h consumption of morphine, time to the morphine request, time to extubation, and adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",60.0,0.170427,"The lidocaine group had a lower pain intensity than the saline group for up to 1 h, with no differences between groups in IL-6 and time to extubation.","[{'ForeName': 'Caio Marcio Barros', 'Initials': 'CMB', 'LastName': 'de Oliveira', 'Affiliation': 'Universidade Federal do Maranhão, São Luís, Brazil.'}, {'ForeName': 'Lais Maria Gaspar', 'Initials': 'LMG', 'LastName': 'Coelho', 'Affiliation': 'Universidade Federal do Maranhão, São Luís, Brazil.'}, {'ForeName': 'José Aparecido', 'Initials': 'JA', 'LastName': 'Valadão', 'Affiliation': 'Universidade Federal do Maranhão, São Luís, Brazil.'}, {'ForeName': 'Ed Carlos Rey', 'Initials': 'ECR', 'LastName': 'Moura', 'Affiliation': 'Universidade Federal do Maranhão, São Luís, Brazil.'}, {'ForeName': 'Antônio Augusto Moura', 'Initials': 'AAM', 'LastName': 'da Silva', 'Affiliation': 'Universidade Federal do Maranhão, São Luís, Brazil.'}, {'ForeName': 'Roclides Castro', 'Initials': 'RC', 'LastName': 'de Lima', 'Affiliation': 'Universidade Federal do Maranhão, São Luís, Brazil.'}, {'ForeName': 'Milena Karina Coló', 'Initials': 'MKC', 'LastName': 'Brunialti', 'Affiliation': 'Universidade Federal de São Paulo, Rua Botucatu 593, São Paulo, 04023-900, Brazil.'}, {'ForeName': 'Reinaldo', 'Initials': 'R', 'LastName': 'Salomão', 'Affiliation': 'Universidade Federal de São Paulo, Rua Botucatu 593, São Paulo, 04023-900, Brazil.'}, {'ForeName': 'Plinio', 'Initials': 'P', 'LastName': 'da Cunha Leal', 'Affiliation': 'Universidade Federal do Maranhão, São Luís, Brazil.'}, {'ForeName': 'Rioko Kimiko', 'Initials': 'RK', 'LastName': 'Sakata', 'Affiliation': 'Universidade Federal de São Paulo, Rua Botucatu 593, São Paulo, 04023-900, Brazil. rsakata@unifesp.br.'}]",Obesity surgery,['10.1007/s11695-020-04748-1'] 641,32534080,Photographic assessment of postsurgical facial scars epidermally sutured with rapidly absorbable polyglactin 910 or nylon: A randomized clinical trial.,"BACKGROUND Surgeons use absorbable and nonabsorbable sutures for epidermal wound closure. No large, randomized studies have compared the effect of these suture types on facial scar appearance. OBJECTIVE To assess postsurgical facial scar appearance using either rapidly absorbable polyglactin 910 or nylon for epidermal closure. METHODS Randomized, blinded, split-scar clinical trial. A total of 105 patients with facial wounds resulting from Mohs micrographic surgery excisions were randomly assigned for epidermal closure with rapidly absorbable 5-0 polyglactin 910 (Vicryl Rapide) on one half of the repair and 5-0 nylon (Ethilon) on the other half. Two physicians (1 dermatologist and 1 plastic surgeon), unaware of the original suture location, examined photographs of each healed wound at 6 months after surgery and graded the appearance of each half of the scar using the visual analog scale, wound evaluation scale, and Stony Brook Scar Evaluation Scale. RESULTS At 6 months, there was no significant difference in the combined mean (standard deviation) visual analog scale scores (83.1 [14.2] and 83.0 [13.7]), Stony Brook Scar Evaluation Scale scores (4.3 [0.9] and 4.4 [0.9]), or wound evaluation scale scores (5.3 [1.1] and 5.2 [1.1]) for rapidly absorbable polyglactin 910 versus nylon (P = .72, .57, and .21, respectively). LIMITATIONS Single institution. CONCLUSIONS Both rapidly absorbable polyglactin 910 and nylon sutures placed through the epidermis resulted in an equivalent photographic appearance of facial scars at 6 months after surgery.",2020,Both rapidly-absorbable polyglactin 910 and nylon sutures placed through epidermis resulted in an equivalent photographic appearance of facial scars at six-months postoperatively.,['105 patients with facial wounds resulting from MMS excisions'],"['rapidly-absorbable polyglactin 910 or nylon', 'absorbable and non-absorbable sutures', 'epidermal closure using rapidly-absorbable 5-0 polyglactin 910 (Vicryl Rapide™) on one half of the repair, and 5-0 nylon (Ethilon™) on the other half', 'Photographic assessment of post-surgical facial scars epidermally sutured with rapidly-absorbable polyglactin 910 or nylon']","['equivalent photographic appearance of facial scars', 'visual analog scale (VAS), wound evaluation scale (WES), and Stony Brook scar evaluation scale (SBSES', 'WES scores', 'combined mean (SD) VAS scores', 'facial scar appearance']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0025706', 'cui_str': 'Methylmesilate'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0032495', 'cui_str': 'Polygalactin 910'}, {'cui': 'C0028736', 'cui_str': 'Nylon'}, {'cui': 'C0461628', 'cui_str': 'Non-absorbable suture'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0947694', 'cui_str': 'Vicryl'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205863', 'cui_str': 'Ethilon'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2229249', 'cui_str': 'Scar of face'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}]","[{'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C2229249', 'cui_str': 'Scar of face'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",105.0,0.110754,Both rapidly-absorbable polyglactin 910 and nylon sutures placed through epidermis resulted in an equivalent photographic appearance of facial scars at six-months postoperatively.,"[{'ForeName': 'Benvon', 'Initials': 'B', 'LastName': 'Moran', 'Affiliation': ""Department of Dermatology and Skin Science, University of British Columbia, Vancouver, Canada; Division of Dermatology, Queen's University, Kingston, Ontario, Canada. Electronic address: benvon.moran@queensu.ca.""}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Humphrey', 'Affiliation': 'Department of Dermatology and Skin Science, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Seal', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Berkowitz', 'Affiliation': 'Sauder School of Business, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Zloty', 'Affiliation': 'Department of Dermatology and Skin Science, University of British Columbia, Vancouver, Canada.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.06.016'] 642,32541643,"Effects of Valsartan on Restenosis in Patients with Arteriosclerosis Obliterans of the Lower Extremities Undergoing Interventional Therapy: A Prospective, Randomized, Single-Blind Trial.","BACKGROUND The aim of this study was to further clarify the effects of valsartan on restenosis in patients with arteriosclerosis obliterans of the lower extremities. MATERIAL AND METHODS Patients with arteriosclerosis obliterans of the lower extremities undergoing continuous stent implantation in the superficial femoral artery were enrolled and randomly divided into an ARB group and a control group. Patients in the ARB group received valsartan orally in a single-blind manner and were followed up for 6 months. An evaluation was performed based on the criteria for clinical efficacies designed by the Committee of Vascular Disease, Chinese Association of Integrative Medicine. The total clinical effective rate was calculated, and ankle brachial index (ABI) of the patients was assessed. The concentrations of interleukin-6 (IL-6) and high-sensitivity C-reactive protein (hs-CRP) were measured using enzyme-linked immunosorbent assay. The in-stent restenosis of patients was examined by angiography. RESULTS One patient in the control group died due to acute cerebral hemorrhage 4 months after enrollment, and 1 patient was lost to follow-up due to acute myocardial infarction during follow-up 5 months after enrollment. Age, sex, Fontaine stage, and underlying diseases were comparable between the 2 groups. Hs-CRP (3.93±1.43) and IL-6 (11.26±2.29) levels were significant different in the ARB group compared with the control group. The postoperative follow-up showed that ABI was 0.98±0.20 in the ARB group and 0.62±0.48 in the control group. CONCLUSIONS Valsartan inhibited the increase in hs-CRP and IL-6 levels, improved clinical efficacies, increased ABI, and decreased the restenosis rate after the interventional therapy in patients with arteriosclerosis obliterans of the lower extremities.",2020,Hs-CRP (3.93±1.43) and IL-6 (11.26±2.29) levels were significant different in the ARB group compared with the control group.,"['patients with arteriosclerosis obliterans of the lower extremities', 'Patients with Arteriosclerosis Obliterans of the Lower Extremities Undergoing Interventional Therapy', 'Patients with arteriosclerosis obliterans of the lower extremities undergoing continuous stent implantation in the superficial femoral artery']","['valsartan', 'Valsartan', 'ARB']","['total clinical effective rate', 'acute myocardial infarction', 'clinical efficacies, increased ABI', 'hs-CRP and IL-6 levels', 'ABI', 'restenosis rate', 'acute cerebral hemorrhage', 'ankle brachial index (ABI', 'Hs-CRP (3.93±1.43) and IL-6 (11.26±2.29) levels', 'concentrations of interleukin-6 (IL-6) and high-sensitivity C-reactive protein (hs-CRP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003850', 'cui_str': 'Arteriosclerosis'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0447106', 'cui_str': 'Superficial femoral artery'}]","[{'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1328319', 'cui_str': 'Ankle brachial pressure index'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0416997,Hs-CRP (3.93±1.43) and IL-6 (11.26±2.29) levels were significant different in the ARB group compared with the control group.,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yao', 'Affiliation': 'Department of Cardiology, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine of Hebei Province, Cangzhou, Hebei, China (mainland).'}, {'ForeName': 'Lixin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Interventional Vascular Surgery, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine of Hebei Province, Cangzhou, Hebei, China (mainland).'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine of Hebei Province, Cangzhou, Hebei, China (mainland).'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine of Hebei Province, Cangzhou, Hebei, China (mainland).'}, {'ForeName': 'Nana', 'Initials': 'N', 'LastName': 'Feng', 'Affiliation': 'Department of Cardiology, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine of Hebei Province, Cangzhou, Hebei, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.919977'] 643,32548904,Evaluation of the Efficacy of Ultrapulsed CO 2 Laser in Chronic Wounds.,"BACKGROUND AND OBJECTIVES Chronic wound repair is a major problem in wound treatment. Recently, several studies have suggested that carbon dioxide (CO 2 ) laser can be used to improve the healing of chronic wounds. The aim of the present study was to preliminarily investigate the efficacy of laser debridement in treating chronic wound through a comparison of traditional instrument/surgical debridement with the ultrapulsed CO 2 laser debridement in terms of wound healing, wound infection control, and wound blood perfusion. STUDY DESIGN/MATERIALS AND METHODS Patients with chronic wound admitted to the Wound Repair Clinic at The Affiliated Hospital of Southwest Medical University (Luzhou, China) between February 2019 and May 2019 were enrolled. They were randomly divided into two groups. The patients in one group were treated with traditional sharp instrument/surgical debridement (RT group; number of wounds: 28), while the patients in the other group were treated with ultrapulsed CO 2 laser debridement (LT group; number of wounds: 26). An intergroup comparison was performed based on parameters, such as wound healing, wound infection control, and changes in wound blood perfusion. RESULTS The wound healing rate and the total time to achieve healing were significantly better in the LT group versus the RT group at 7, 14, 21, and 28 days after treatment. The wound exudation scores were significantly higher in the LT group versus the RT group at 7, 14, and 28 days after treatment. The positive rate of pre-debridement bacterial culture was significantly lower in the LT group versus the RD group at 14 and 28 days after treatment. The percentage of wound perfusion/normal periwound skin perfusion was significantly higher in the LT group versus the RT group at 1, 7, and 14 days after treatment. CONCLUSION For the treatment of chronic refractory wounds, the ultrapulsed CO 2 laser exhibits higher accuracy, more effectively controls wound infection, promotes an increase in wound blood perfusion, and achieves faster wound healing compared with traditional sharp instrument/surgical debridement. Lasers Surg. Med. © 2020 Wiley Periodicals LLC.",2021,"The percentage of wound perfusion/normal periwound skin perfusion was significantly higher in the LT group versus the RT group at 1, 7, and 14 days after treatment. ","['Patients with chronic wound admitted to the Wound Repair Clinic at The Affiliated Hospital of Southwest Medical University (Luzhou, China) between February 2019 and May 2019 were enrolled', 'Chronic Wounds']","['laser debridement', 'ultrapulsed CO 2 laser debridement', 'traditional sharp instrument/surgical debridement (RT', 'Ultrapulsed CO 2 Laser', 'carbon dioxide (CO 2 ) laser']","['wound healing, wound infection control, and changes in wound blood perfusion', 'wound exudation scores', 'wound healing, wound infection control, and wound blood perfusion', 'wound healing rate and the total time to achieve healing', 'positive rate of pre-debridement bacterial culture', 'wound healing', 'percentage of wound perfusion/normal periwound skin perfusion', 'wound blood perfusion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0336668', 'cui_str': 'Sharp instrument'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0311437', 'cui_str': 'Exudation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0430402', 'cui_str': 'Bacterial culture'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]",,0.0252332,"The percentage of wound perfusion/normal periwound skin perfusion was significantly higher in the LT group versus the RT group at 1, 7, and 14 days after treatment. ","[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Jiang', 'Affiliation': 'Department of Plastic and Burn Surgery, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, 646000, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Tang', 'Affiliation': 'Department of Plastic and Burn Surgery, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, 646000, China.'}, {'ForeName': 'Danyu', 'Initials': 'D', 'LastName': 'Zheng', 'Affiliation': 'Department of Plastic and Burn Surgery, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, 646000, China.'}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Plastic and Burn Surgery, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, 646000, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Plastic and Burn Surgery, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, 646000, China.'}, {'ForeName': 'Ruxi', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Department of Plastic and Burn Surgery, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, 646000, China.'}, {'ForeName': 'Ligang', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Plastic and Burn Surgery, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, 646000, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': 'Department of Plastic and Burn Surgery, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, 646000, China.'}]",Lasers in surgery and medicine,['10.1002/lsm.23283'] 644,32561941,A randomized in vitro evaluation of transient and permanent cardiac implantable electronic device malfunctions following direct exposure up to 10 Gy.,"BACKGROUND AND PURPOSE High-dose 6‑MV radiotherapy may cause cardiac implantable electronic devices (CIEDs) to malfunction. To assess CIED malfunctions resulting from direct exposure up to 10 Gy, 100 pacemakers (PMs) and 40 implantable cardioverter-defibrillators (ICDs) were evaluated. MATERIALS AND METHODS CIEDs underwent baseline interrogation. In ICDs, antitachycardia therapies were disabled via the programmer while the detection windows were left enabled. A computed tomography (CT) scan was performed to build the corresponding treatment plan. CIEDs were ""blinded"" and randomized to receive single doses of either 2, 5, or, 10 Gy via a 6-MV linear accelerator (linac) in a water phantom. Twenty-two wireless telemetry-enabled CIEDs underwent a real-time session, and their function was recorded by the video camera in the bunker. The CIEDs were interrogated after exposure and once monthly for 6 months. RESULTS During exposure, regardless of dose, 90.9% of the CIEDs recorded electromagnetic interference, with 6 ICDs (27.3%) reporting pacing inhibition and inappropriate arrhythmia detections. After exposure, a backup reset was observed in 1 PM (0.7% overall, 1% among PMs), while 7 PMs (5% overall, 7% among PMs) reported battery issues (overall immediate malfunction rate was 5.7%). During follow-up, 4 PMs (2.9% overall; 4% among PMs) and 1 ICD (0.7% overall; 2.5% among ICDs) reported abnormal battery depletion, and 1 PM (0.7% overall; 1% among PMs) reported a backup reset (overall late malfunction rate was 4.3%). CONCLUSION Apart from transient electromagnetic interference, last-generation CIEDs withstood direct 6‑MV exposure up to 10 Gy. Permanent battery or software errors occurred immediately or later only in less recent CIEDs.",2021,"During exposure, regardless of dose, 90.9% of the CIEDs recorded electromagnetic interference, with 6 ICDs (27.3%) reporting pacing inhibition and inappropriate arrhythmia detections.",[],"['A\xa0computed tomography (CT) scan', '6‑MV radiotherapy', 'transient and permanent cardiac implantable electronic device malfunctions']","['pacing inhibition and inappropriate arrhythmia detections', 'electromagnetic interference', 'Permanent battery or software errors', 'abnormal battery depletion']",[],"[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C1504465', 'cui_str': 'Device malfunction'}]","[{'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C1504600', 'cui_str': 'Electromagnetic interference'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}]",,0.0740967,"During exposure, regardless of dose, 90.9% of the CIEDs recorded electromagnetic interference, with 6 ICDs (27.3%) reporting pacing inhibition and inappropriate arrhythmia detections.","[{'ForeName': 'Maria Daniela', 'Initials': 'MD', 'LastName': 'Falco', 'Affiliation': 'Department of Radiation Oncology, ""SS. Annunziata"" Hospital, ""G. D\'Annunzio"" University, Via De\' Vestini, 66100, Chieti, Italy. mdanielafalco@hotmail.com.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Genovesi', 'Affiliation': 'Department of Radiation Oncology, ""SS. Annunziata"" Hospital, ""G. D\'Annunzio"" University, Via De\' Vestini, 66100, Chieti, Italy.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Caravatta', 'Affiliation': 'Department of Radiation Oncology, ""SS. Annunziata"" Hospital, ""G. D\'Annunzio"" University, Via De\' Vestini, 66100, Chieti, Italy.'}, {'ForeName': 'Clelia', 'Initials': 'C', 'LastName': 'Di Carlo', 'Affiliation': 'Department of Radiation Oncology, ""SS. Annunziata"" Hospital, ""G. D\'Annunzio"" University, Via De\' Vestini, 66100, Chieti, Italy.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Bliakharskaia', 'Affiliation': ""Department of Clinical Medicine, Public Health, Life and Environmental Sciences, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Appignani', 'Affiliation': 'Intensive Cardiac Care Unit, ""SS. Annunziata"" Hospital, Chieti, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Faustino', 'Affiliation': 'Arrhythmology Unit, ""SS. Annunziata"" Hospital, Chieti, Italy.'}, {'ForeName': 'Nanda', 'Initials': 'N', 'LastName': 'Furia', 'Affiliation': 'Arrhythmology Unit, ""SS. Annunziata"" Hospital, Chieti, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Di Girolamo', 'Affiliation': 'Arrhythmology Unit, ""SS. Annunziata"" Hospital, Chieti, Italy.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-020-01651-7'] 645,32564051,Treatment of Temporomandibular Joint Disorders by Ultrashort Wave and Extracorporeal Shock Wave: A Comparative Study.,"BACKGROUND This study was carried out to compare the therapeutic efficacy of extracorporeal shock wave (ESW) and ultrashort wave (UW) for temporomandibular joint disorder (TMD). MATERIAL AND METHODS A total of 80 patients with myofascial pain and TMD were enrolled in this study. The subjects were randomized to receive ESW or UW treatments. Patients in the ESW group received 1 ESW treatment for 4 weeks and patients in the US group were given US treatment once a day for 5 days per week for 4 weeks. The pain was measured using visual analog scale (VAS) and mouth opening was determined as pain-free maximum mouth opening (MMO) before and 4 weeks after the treatments. Other parameters assessed included functional indexes of temporomandibular joint such as mandibular movement (MM), joint noise (JN), joint press (JP), and disability index (DI). RESULTS After therapy, VAS, MMO, MM, JN, JP, and DI in ESW group, and VAS in UW group were significantly improved (P<0.05) as compared to before therapy. VAS, MMO, and the functional indexes of temporomandibular joint in the ESW group were significantly better than those in the UW group (1.79 vs. 2.00, 3.23 vs. 2.03, 1.79 vs. 2.41, 1.45 vs. 2.27, 1.55 vs. 2.59, and 3.30 vs. 4.79, respectively. P<0.05). CONCLUSIONS ESW significantly reduces pain and improves the functional indexes of temporomandibular joint and mouth opening limit for TMD patients as compared with UW therapy.",2020,CONCLUSIONS ESW significantly reduces pain and improves the functional indexes of temporomandibular joint and mouth opening limit for TMD patients as compared with UW therapy.,"['temporomandibular joint disorder (TMD', '80 patients with myofascial pain and TMD']","['extracorporeal shock wave (ESW) and ultrashort wave (UW', 'ESW', 'Ultrashort Wave and Extracorporeal Shock Wave']","['VAS, MMO, MM, JN, JP, and DI', 'functional indexes of temporomandibular joint such as mandibular movement (MM), joint noise (JN), joint press (JP), and disability index (DI', 'visual analog scale (VAS) and mouth opening was determined as pain-free maximum mouth opening (MMO', 'pain', 'functional indexes of temporomandibular joint and mouth opening limit', 'VAS, MMO, and the functional indexes of temporomandibular joint']","[{'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0553642', 'cui_str': 'Myofascial pain'}]","[{'cui': 'C0442087', 'cui_str': 'Extracorporeal'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0277829', 'cui_str': 'Noises in joint'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0039493', 'cui_str': 'Temporomandibular joint structure'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]",80.0,0.0591111,CONCLUSIONS ESW significantly reduces pain and improves the functional indexes of temporomandibular joint and mouth opening limit for TMD patients as compared with UW therapy.,"[{'ForeName': 'Wenyan', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Rehabilitation, The First Hospital of Shanxi Medical University, Taiyuan, Shanxi, China (mainland).'}, {'ForeName': 'Junying', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Rehabilitation, The First Hospital of Shanxi Medical University, Taiyuan, Shanxi, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.923461'] 646,32444166,Effective support following recurrent pregnancy loss: a randomized controlled feasibility and acceptability study.,"RESEARCH QUESTION Is it feasible to perform a future definitive trial to determine the effectiveness of the positive reappraisal coping intervention (PRCI) in improving the psychological well-being of women with recurrent pregnancy loss (RPL) during the early stages of a new pregnancy? DESIGN This mixed method study aimed to establish the feasibility of conducting a multicentre randomized controlled trial (RCT) to definitively test the effects of the PRCI on the psychological well-being of women with RPL. Participants (n = 75) were recruited to the study and at the point of a positive pregnancy test, 47 were randomized into two study groups. The intervention group received the PRCI and weekly questionnaire assessment (Hospital Anxiety and Depression Scale and Weekly Record Keeping Form [WRK]) to monitor psychological well-being; the control group received the same questionnaires. Nested within the RCT was a qualitative process evaluation (QPE) exploring participants' subjective experience of study methods and the intervention. The study was conducted over a two-year period between 2014 and 2016. RESULTS This study successfully gathered knowledge about the feasibility aspects of conducting a future multicentre definitive study to determine the effects of the PRCI on the psychological well-being of women with RPL. Participants were receptive to its use and the intervention appeared to convey benefits with no apparent downside. CONCLUSIONS The study concluded that a definitive RCT of the PRCI is possible and that the model of care already has the potential to be made more widely available as a safe, low-cost, convenient and easily deliverable intervention to provide much-needed support to a vulnerable patient population.",2020,"Participants were receptive to its use and the intervention appeared to convey benefits with no apparent downside. ","['women with recurrent pregnancy loss (RPL) during the early stages of a new pregnancy', 'Participants (n\u202f=\u202f75) were recruited to the study and at the point of a positive pregnancy test, 47 were randomized into two study groups', 'two-year period between 2014 and 2016', 'women with RPL']","['positive reappraisal coping intervention (PRCI', 'PRCI and weekly questionnaire assessment (Hospital Anxiety and Depression Scale and Weekly Record Keeping Form [WRK]) to monitor psychological well-being; the control group received the same questionnaires', 'PRCI']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0156740', 'cui_str': 'Pregnancy in habitual aborter'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0240802', 'cui_str': 'Pregnancy test positive'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],75.0,0.0546913,"Participants were receptive to its use and the intervention appeared to convey benefits with no apparent downside. ","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bailey', 'Affiliation': 'University Hospitals Southampton NHS Foundation Trust, Princess Anne Hospital, Coxford Road, Southampton SO16 5YA, UK; Faculty of Health Sciences, University of Southampton, University Road, Southampton SO17 1BJ, UK. Electronic address: sarahl.bailey@soton.ac.uk.'}, {'ForeName': 'Jacky', 'Initials': 'J', 'LastName': 'Boivin', 'Affiliation': 'School of Psychology, Cardiff University, 70 Park Place, Cardiff Wales CF10 3AT, UK.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheong', 'Affiliation': 'Faculty of Medicine, University of Southampton, University Road, Southampton SO17 1BJ, UK; Complete Fertility Centre, Princess Anne Hospital, Coxford Road, Southampton SO16 5YA, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bailey', 'Affiliation': 'Faculty of Health Sciences, University of Southampton, University Road, Southampton SO17 1BJ, UK.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Kitson-Reynolds', 'Affiliation': 'Faculty of Health Sciences, University of Southampton, University Road, Southampton SO17 1BJ, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Macklon', 'Affiliation': 'Faculty of Medicine, University of Southampton, University Road, Southampton SO17 1BJ, UK; Complete Fertility Centre, Princess Anne Hospital, Coxford Road, Southampton SO16 5YA, UK.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.01.022'] 647,32447635,Weight Loss and Eating Pattern 7 Years After Sleeve Gastrectomy: Experience of a Bariatric Center of Excellence.,"PURPOSE Report the analysis from a single center series of consecutive primary sleeve gastrectomy (SG) on the factors affecting weight loss at long term. MATERIALS AND METHODS Patients submitted to primary SG with a follow-up of 7 years were screened. Weight loss was evaluated with %excess weight loss (%EWL) and %excess BMI loss (%BMIL). Weight regain (WR) was defined as in increase of 25% of the obtained %EWL and insufficient weight loss (IWL) as loss < 50% EWL. Eating behaviors were evaluated with 7 days record (7dR). All the variables potentially affecting the weight loss were cross-matched for correlation. The study population was divided in three groups: group A (WR), group B (IWL), and group C (sustained weight loss) for comparative analysis. RESULTS A total of 86 patients (21 M/65 F) with a preoperative BMI of 47.08 ± 6.15 kg/m 2 were evaluated. Cumulative 7 years weight loss was as follows: 61.66 ± 22.69% EWL and 32 ± 9% EBMIL. A total of 4.6% had an IWL while 27.9% a WR. The analysis showed a significant difference among the daily calories and fats consuming, number of meals, physical activity, grazing/sweet eating habits, and adherence to follow-up (p < 0.05) between groups A and C. Cox hazard demonstrated a significant risk (p < 0.05) to WR in case of adherence to follow-up shorter than 48 months, high daily calories, and fats intake (hazard ratio (HR) range 5-9). Eight patients (9.3%) had a surgical revision. CONCLUSION Our data demonstrated that long-term results (7 years) of SG are strongly related to eating habits and patient's behaviors.",2020,"A and C. Cox hazard demonstrated a significant risk (p < 0.05) to WR in case of adherence to follow-up shorter than 48 months, high daily calories, and fats intake (hazard ratio (HR) range 5-9).","['86 patients (21 M/65 F) with a preoperative BMI of 47.08\u2009±\u20096.15\xa0kg/m 2 were evaluated', 'Patients submitted to primary SG with a follow-up of 7\xa0years were screened']","['Sleeve Gastrectomy', 'consecutive primary sleeve gastrectomy (SG']","['Weight regain (WR', 'Weight loss', 'surgical revision', 'BMI loss', 'Eating behaviors', 'Weight Loss and Eating Pattern 7\xa0Years', 'weight loss', 'daily calories and fats consuming, number of meals, physical activity, grazing/sweet eating habits, and adherence to follow-up']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",86.0,0.0202136,"A and C. Cox hazard demonstrated a significant risk (p < 0.05) to WR in case of adherence to follow-up shorter than 48 months, high daily calories, and fats intake (hazard ratio (HR) range 5-9).","[{'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Iossa', 'Affiliation': 'Department of Medical-Surgical Sciences and Biotechnologies, Division of General Surgery and Bariatric Centre of Excellence, University of Rome ""La Sapienza"", Rome, Italy. angelo.iossa@gmail.com.'}, {'ForeName': 'Ilenia', 'Initials': 'I', 'LastName': 'Coluzzi', 'Affiliation': 'Department of Medical-Surgical Sciences and Biotechnologies, Division of General Surgery and Bariatric Centre of Excellence, University of Rome ""La Sapienza"", Rome, Italy.'}, {'ForeName': 'Isabella Bianca', 'Initials': 'IB', 'LastName': 'Giannetta', 'Affiliation': 'Department of Medical-Surgical Sciences and Biotechnologies, Division of General Surgery and Bariatric Centre of Excellence, University of Rome ""La Sapienza"", Rome, Italy.'}, {'ForeName': 'Gianfranco', 'Initials': 'G', 'LastName': 'Silecchia', 'Affiliation': 'Department of Medical-Surgical Sciences and Biotechnologies, Division of General Surgery and Bariatric Centre of Excellence, University of Rome ""La Sapienza"", Rome, Italy.'}]",Obesity surgery,['10.1007/s11695-020-04699-7'] 648,32447638,"Effects of Whole-Body Electromyostimulation Associated with Dynamic Exercise on Functional Capacity and Heart Rate Variability After Bariatric Surgery: a Randomized, Double-Blind, and Sham-Controlled Trial.","PURPOSE Bariatric surgery is the most effective treatment for morbid obesity. In association with dietary restrictions, the ability to exercise in the immediate post-surgical phase is limited. In this context, whole-body electromyostimulation (WB-EMS), strategy that stimulates various muscle groups, in conjunction with physical exercise, holds promise for improving functional capacity, and cardiac autonomic control, following surgery. The purpose of this study was to analyze whether a rehabilitation program consisting of WB-EMS with 30 exercise training sessions following bariatric surgery significantly improves functional capacity, body mass and heart rate variability (HRV). METHODS Randomized, double-blind, and sham-controlled trial. Twenty obesity patients were randomized into the WB-EMS (n = 10) and sham (n = 10) groups. On average, 7 days after surgery, individuals underwent a six-minute walk test (6MWT), HRV, and body composition analysis at rest. The next day, patients initiated an exercise training protocol, five times per week, over 6 weeks. Walking distance changes (post-pre = ΔWD) obtained by 6MWT and HRV indices were determined following the intervention. RESULTS Only WB-EMSG significantly increased WD and body mass index (BMI) after the intervention (p = 0.002) and ΔWD was significantly higher in this group when compared with sham (p = 0.04). Moreover, both groups demonstrated an improvement in key measures of HRV after the intervention. CONCLUSION An exercise training intervention initiated shortly after bariatric surgery improved functional capacity and cardiac autonomic tone. Improvements in functional capacity and BMI following exercise training were greater with the addition of WB-EMS but did not promote additional improvements in HRV beyond that realized with exercise training alone.",2020,Improvements in functional capacity and BMI following exercise training were greater with the addition of WB-EMS but did not promote additional improvements in HRV beyond that realized with exercise training alone.,['Twenty obesity patients'],"['WB-EMS', 'exercise training intervention', 'Whole-Body Electromyostimulation Associated with Dynamic Exercise', 'exercise training protocol']","['functional capacity and BMI', '6MWT and HRV indices', 'WD and body mass index (BMI', 'HRV', 'functional capacity, body mass and heart rate variability (HRV', 'Functional Capacity and Heart Rate Variability', 'functional capacity and cardiac autonomic tone', 'Walking distance changes']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",20.0,0.380533,Improvements in functional capacity and BMI following exercise training were greater with the addition of WB-EMS but did not promote additional improvements in HRV beyond that realized with exercise training alone.,"[{'ForeName': 'Paula Angélica', 'Initials': 'PA', 'LastName': 'Ricci', 'Affiliation': 'Cardiopulmonary Physical Therapy Laboratory, Federal University of Sao Carlos- UFSCar, Rod. Washington Luis, km 235, São Carlos, SP, CEP: 13565-905, Brazil.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Di Thommazo-Luporini', 'Affiliation': 'Cardiopulmonary Physical Therapy Laboratory, Federal University of Sao Carlos- UFSCar, Rod. Washington Luis, km 235, São Carlos, SP, CEP: 13565-905, Brazil.'}, {'ForeName': 'Soraia Pilon', 'Initials': 'SP', 'LastName': 'Jürgensen', 'Affiliation': 'Cardiopulmonary Physical Therapy Laboratory, Federal University of Sao Carlos- UFSCar, Rod. Washington Luis, km 235, São Carlos, SP, CEP: 13565-905, Brazil.'}, {'ForeName': 'Larissa Delgado', 'Initials': 'LD', 'LastName': 'André', 'Affiliation': 'Cardiopulmonary Physical Therapy Laboratory, Federal University of Sao Carlos- UFSCar, Rod. Washington Luis, km 235, São Carlos, SP, CEP: 13565-905, Brazil.'}, {'ForeName': 'Guilherme Focchi', 'Initials': 'GF', 'LastName': 'Haddad', 'Affiliation': 'Gastro Vita (Medical Specialities Center), Araraquara, SP, Brazil.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Arena', 'Affiliation': 'Department of Physical Therapy, College of Applied Health Sciences, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Borghi-Silva', 'Affiliation': 'Cardiopulmonary Physical Therapy Laboratory, Federal University of Sao Carlos- UFSCar, Rod. Washington Luis, km 235, São Carlos, SP, CEP: 13565-905, Brazil. audrey@ufscar.br.'}]",Obesity surgery,['10.1007/s11695-020-04724-9'] 649,32512314,Women's unmet needs in early labour: Qualitative analysis of free-text survey responses in the M@NGO trial of caseload midwifery.,"OBJECTIVE to analyse women's experiences of early labour care in caseload midwifery in Australia. DESIGN this study sits within a multi-site randomised controlled trial of caseload midwifery versus standard care. Participant surveys were conducted at 6-weeks and 6-months after birth. Free-text responses about experiences of care were subject to critical thematic analysis in NVivo 11 software. SETTING two urban Australian hospitals in different states. PARTICIPANTS women 18 years and over, with a singleton pregnancy, less than 24 weeks' pregnant, not planning a caesarean section or already booked with a care provider; were eligible to participate in the trial. INTERVENTIONS participants were randomised to caseload midwifery or standard care for antenatal, labour and birth and postpartum care. MEASUREMENTS AND FINDINGS The 6-week survey response rate was 58% (n = 1,019). The survey included five open questions about women's experiences of pregnancy, labour and birth, and postnatal care. Nine-hundred and one respondents (88%) provided free text comments which were coded to generate 10 categories. The category of early labour contained data from 84 individual participants (caseload care n = 44; standard care n = 40). Descriptive themes were: (1) needing permission; (2) doing the 'wrong' thing; and (3) being dismissed. Analytic themes were: (1) Seeking: women wanting to be ""close to those who know what's going on""; and (2) Shielding: midwives defending resources and normal birth. KEY CONCLUSIONS Regardless of model of care, early labour care was primarily described in negative terms. This could be attributed to reporting bias, because women who were neutral about early labour care may not comment. Nevertheless, the findings demonstrate a gap in knowledge about early labour care in caseload midwifery models. IMPLICATIONS FOR PRACTICE Maternity services that offer caseload midwifery are ideally placed to evaluate how early labour home visiting impacts women's experiences of early labour.",2020,"IMPLICATIONS FOR PRACTICE Maternity services that offer caseload midwifery are ideally placed to evaluate how early labour home visiting impacts women's experiences of early labour.","['two urban Australian hospitals in different states', 'Nine-hundred and one respondents (88%) provided free text comments which were coded to generate 10 categories', '84 individual participants (caseload care n\xa0=\xa044; standard care n\xa0=\xa040', ""Women's unmet needs in early labour"", ""women's experiences of early labour care in caseload midwifery in Australia"", ""women 18 years and over, with a singleton pregnancy, less than 24 weeks' pregnant, not planning a caesarean section or already booked with a care provider; were eligible to participate in the trial""]","['caseload midwifery versus standard care', 'caseload midwifery or standard care for antenatal, labour and birth and postpartum care']","['pregnancy, labour and birth, and postnatal care']","[{'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0282411', 'cui_str': 'Editorial Comment'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1171200', 'cui_str': 'Labor care'}, {'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}]","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}]",,0.0808094,"IMPLICATIONS FOR PRACTICE Maternity services that offer caseload midwifery are ideally placed to evaluate how early labour home visiting impacts women's experiences of early labour.","[{'ForeName': 'Jyai', 'Initials': 'J', 'LastName': 'Allen', 'Affiliation': 'Mater Research Institute-The University of Queensland, Brisbane, Queensland, Australia; School of Nursing and Midwifery, Griffith University, Meadowbrook, Queensland, Australia. Electronic address: jyai.allen@griffith.edu.au.'}, {'ForeName': 'Bec', 'Initials': 'B', 'LastName': 'Jenkinson', 'Affiliation': 'Mater Research Institute-The University of Queensland, Brisbane, Queensland, Australia. Electronic address: bec.jenkinson@mater.uq.edu.au.'}, {'ForeName': 'Sally K', 'Initials': 'SK', 'LastName': 'Tracy', 'Affiliation': ""Midwifery and Women's Health Research Unit, University of Sydney, Royal Hospital for Women, Randwick, New South Wales, Australia. Electronic address: sally.tracy@sydney.edu.au.""}, {'ForeName': 'Donna L', 'Initials': 'DL', 'LastName': 'Hartz', 'Affiliation': ""Midwifery and Women's Health Research Unit, University of Sydney, Royal Hospital for Women, Randwick, New South Wales, Australia; College of Nursing and Midwifery, Charles Darwin University, Sydney Campus, New South Wales, Australia. Electronic address: donna.hartz@cdu.edu.au.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tracy', 'Affiliation': ""Department of Paediatrics and Child health Westmead Children's Clinical School, The University of Sydney, Westmead, New South Wales, Australia; Westmead Neonatal Intensive Care Unit, Westmead Hospital, Western Sydney Local Health District, New South Wales, Australia. Electronic address: mark.tracy@sydney.edu.au.""}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Kildea', 'Affiliation': 'Mater Research Institute-The University of Queensland, Brisbane, Queensland, Australia; Molly Wardaguga Research Centre, College of Nursing and Midwifery, Charles Darwin University, Queensland, Australia. Electronic address: sue.kildea@cdu.edu.au.'}]",Midwifery,['10.1016/j.midw.2020.102751'] 650,32519957,Polidocanol versus phenol in oil injection sclerotherapy in treatment of internal hemorrhoids: A randomized controlled trial.,"BACKGROUND/AIMS Management of Haemorrhoids is suboptimal and is largely based on traditional practices in the Indian population. Though injection sclerotherapy is a well-accepted treatment modality in early grade haemorrhoids, there is no consensus on the effectiveness of the drugs used for sclerotherapy. The study was done to compare the safety and efficacy of a standard sclerosant (polidocanol) and the conventionally used phenol in oil in bleeding grade-1 and 2 internal haemorrhoids. MATERIALS AND METHODS All patients with grade-1 and 2 hemorrhoids, were selected and randomised into two groups, 3% polidocanol and 5% phenol group. All patients were followed-up for three months and observed for ""free of bleeding"" or ""persistent bleeding."" Pain, pruritus and patient satisfaction following the procedure was also assessed. RESULTS A total of 150 patients were enrolled, 75 in each group. At the end of the first sclerotherapy session with polidocanol, 60.6% of patients versus 38.1% in phenol group had stopped per rectal bleeding (p=0.009). After the second sclerotherapy session, 94.7% of patients in the polidocanol group and 84% of patients in the phenol group were treated successfully. Polidocanol group required significantly fewer treatment sessions than the phenol group (1.39±0.49 vs. 1.62±0.49; p=0.035), and the total volume of injected sclerosant was also less (3.30±0.96 mL vs. 4.86±1.46 mL; p=0.001). The patient satisfaction was 87% in polidocanol group versus 73% in phenol group (p=0.040). CONCLUSION 3% polidocanol is safe and more effective than 5% phenol in oil when used as injection sclerotherapy in the treatment of first and second-degree internal hemorrhoids.",2020,"The patient satisfaction was 87% in polidocanol group versus 73% in phenol group (p=0.040). ","['All patients with grade-1 and 2 hemorrhoids', 'A total of 150 patients were enrolled, 75 in each group', 'internal hemorrhoids']","['polidocanol and 5% phenol group', 'polidocanol', 'standard sclerosant (polidocanol', 'Polidocanol versus phenol in oil injection sclerotherapy', 'injection sclerotherapy', 'Polidocanol']","['Pain, pruritus and patient satisfaction', 'total volume of injected sclerosant', 'patient satisfaction', 'safety and efficacy', 'free of bleeding"" or ""persistent bleeding', 'stopped per rectal bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0019112', 'cui_str': 'Hemorrhoids'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0265034', 'cui_str': 'Internal hemorrhoids'}]","[{'cui': 'C0071330', 'cui_str': 'polidocanol'}, {'cui': 'C0031428', 'cui_str': 'Phenols'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0036426', 'cui_str': 'Sclerosing agent'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0036435', 'cui_str': 'Injection of sclerosing agent'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0036426', 'cui_str': 'Sclerosing agent'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0018932', 'cui_str': 'Hematochezia'}]",150.0,0.0796908,"The patient satisfaction was 87% in polidocanol group versus 73% in phenol group (p=0.040). ","[{'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Mishra', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India.'}, {'ForeName': 'Ashok Kumar', 'Initials': 'AK', 'LastName': 'Sahoo', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India.'}, {'ForeName': 'Thirthar Palanivelu', 'Initials': 'TP', 'LastName': 'Elamurugan', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India.'}, {'ForeName': 'Sadasivan', 'Initials': 'S', 'LastName': 'Jagdish', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India.'}]",The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology,['10.5152/tjg.2020.19276'] 651,32521736,"The Effect of Escitalopram on Central Serotonergic and Dopaminergic Systems in Patients with Cervical Dystonia, and Its Relationship with Clinical Treatment Effects: A Double-Blind Placebo-Controlled Trial.","Purpose: The pathophysiology of cervical dystonia (CD) is thought to be related to changes in dopamine and serotonin levels in the brain. We performed a double-blind trial with escitalopram (selective serotonin reuptake inhibitor; SSRI) in patients with CD. Here, we report on changes in dopamine D 2/3 receptor (D2/3R), dopamine transporter (DAT) and serotonin transporter (SERT) binding potential (BP ND ) after a six-week treatment course with escitalopram or placebo. Methods: CD patients had [123I]FP-CIT SPECT (I-123 fluoropropyl carbomethoxy-3 beta-(4-iodophenyltropane) single-photon emission computed tomography) scans, to quantify extrastriatal SERT and striatal DAT, and [123I]IBZM SPECT (I-123 iodobenzamide SPECT) scans to quantify striatal D2/3R BPND before and after six weeks of treatment with either escitalopram or placebo. Treatment effect was evaluated with the Clinical Global Impression scale for dystonia, jerks and psychiatric symptoms, both by physicians and patients. Results: In both patients treated with escitalopram and placebo there were no significant differences after treatment in SERT, DAT or D2/3R BP ND . Comparing scans after treatment with escitalopram (n = 8) to placebo (n = 8) showed a trend ( p = 0.13) towards lower extrastriatal SERT BPND in the SSRI group (median SERT occupancy of 64.6%). After treatment with escitalopram, patients who reported a positive effect on dystonia or psychiatric symptoms had significantly higher SERT occupancy compared to patients who did not experience an effect. Conclusion: Higher extrastriatal SERT occupancy after treatment with escitalopram is associated with a trend towards a positive subjective effect on dystonia and psychiatric symptoms in CD patients.",2020,"In both patients treated with escitalopram and placebo there were no significant differences after treatment in SERT, DAT or D2/3R BP ND .","['patients with CD', 'Patients with Cervical Dystonia, and Its Relationship with Clinical Treatment Effects', 'cervical dystonia (CD', 'CD patients']","['Placebo', '123I]FP-CIT SPECT (I-123 fluoropropyl carbomethoxy-3 beta-(4-iodophenyltropane) single-photon emission computed tomography) scans', 'escitalopram', 'escitalopram or placebo', 'escitalopram (selective serotonin reuptake inhibitor; SSRI', 'Escitalopram', 'placebo']","['SERT, DAT or D2/3R BP ND ', 'Clinical Global Impression scale for dystonia, jerks and psychiatric symptoms', 'Central Serotonergic and Dopaminergic Systems', 'dystonia and psychiatric symptoms', 'dystonia or psychiatric symptoms', 'SERT occupancy', 'extrastriatal SERT BPND', 'extrastriatal SERT occupancy', 'dopamine D 2/3 receptor (D2/3R), dopamine transporter (DAT) and serotonin transporter (SERT) binding potential (BP ND ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0949445', 'cui_str': 'Cervical Dystonia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008864', 'cui_str': 'Citrulline'}, {'cui': 'C0040399', 'cui_str': 'Single photon emission computerized tomography'}, {'cui': 'C3495673', 'cui_str': 'IODIDE ION I-123'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}]","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C3639708', 'cui_str': 'Clinical global impression scale'}, {'cui': 'C0013421', 'cui_str': 'Dystonia'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0114838', 'cui_str': 'Dopamine Transporter'}, {'cui': 'C0170657', 'cui_str': 'Serotonin Transporter'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}]",,0.388244,"In both patients treated with escitalopram and placebo there were no significant differences after treatment in SERT, DAT or D2/3R BP ND .","[{'ForeName': 'Evelien', 'Initials': 'E', 'LastName': 'Zoons', 'Affiliation': 'Department of Neurology, Zaans Medisch Centrum, 1502 DV Zaandam, The Netherlands.'}, {'ForeName': 'Marina A J', 'Initials': 'MAJ', 'LastName': 'Tijssen', 'Affiliation': 'Department of Neurology, University Medical Centre, 9713 GZ Groningen, The Netherlands.'}, {'ForeName': 'Yasmine E M', 'Initials': 'YEM', 'LastName': 'Dreissen', 'Affiliation': 'Department of Neurosurgery, Amsterdam University Medical Centre, location Academic Medical Centre, 1100 DD Amsterdam, The Netherlands.'}, {'ForeName': 'Marenka', 'Initials': 'M', 'LastName': 'Smit', 'Affiliation': 'Department of Neurology, University Medical Centre, 9713 GZ Groningen, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Booij', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, location Academic Medical Centre, 1100 DD Amsterdam, The Netherlands.'}]",Biomolecules,['10.3390/biom10060880'] 652,32686643,Long term oral appliance therapy decreases stress symptoms in patients with upper airway resistance syndrome.,"STUDY OBJECTIVES To evaluate the long-term effects of a mandibular advancement device (MAD) on stress symptoms and cognitive function in patients with upper airway resistance syndrome (UARS) compared with placebo. METHODS This study was a randomized placebo-controlled clinical trial. Thirty UARS patients were randomized into 2 groups: placebo and MAD groups. UARS criteria were the presence of sleepiness (Epworth Sleepiness Scale ≥ 10) and/or fatigue (Modified Fatigue Impact Scale ≥ 38) associated with an apnea-hypopnea index ≤ 5 events/h and a respiratory disturbance index > 5 events/h of sleep, and/or flow limitation in more than 30% of total sleep time. All patients completed the Rey Auditory-Verbal Learning Test, the Logical Memory test, the Stroop Color Test, the Trail Making Test, the Digit Symbol Substitution Test, and Inventory of Stress Symptoms. Cognition protocol was defined based on the most used neuropsychological tests in the literature. Evaluations were performed before and after 1.5 years of treatment. RESULTS Mean adherence to placebo and to MAD was 6.6 ± 2.6 and 6.1 ± 2.4 h/night, respectively. Side effects reported by MAD group were minor and short-term. There was no statistically significant difference in Rey Auditory-Verbal Learning Test, Logical Memory test, Stroop Color Test, Trail Making Test, and Digit Symbol Substitution Test before and after 1.5 years of treatment in both groups. Inventory of Stress Symptoms score decreased at the alert phase and the resistance phase after 1.5 years of MAD treatment compared to the placebo. CONCLUSIONS Mandibular advancement devices were effective in decreasing stress symptoms in UARS patients after 1.5 years of treatment. CLINICAL TRIAL REGISTRATION Registry: ClinicalTrials.gov; Name: Efficacy of Oral Appliance for Upper Airway Resistance Syndrome; URL: https://clinicaltrials.gov/ct2/show/record/NCT02636621; Identifier: NTC02636621.",2020,"There was no statistically significant difference in RAVLT, Logical Memory Test, Stroop Color Test, Trail Making Test, Digit Symbol Substitution Test before and after 1.5 years of treatment in both groups.","['UARS patients after 1.5-years of treatment', 'Thirty UARS patients', 'Upper Airway Resistance Syndrome', 'patients with upper airway resistance syndrome', 'patients with UARS compared with placebo']","['Placebo', 'mandibular advancement device (MAD', 'appliance therapy', 'placebo and MAD', 'Oral Appliance', 'MAD', 'placebo']","['stress symptoms and cognitive function', 'RAVLT, Logical Memory Test, Stroop Color Test, Trail Making Test, Digit Symbol Substitution Test', 'stress symptoms', 'ISSL score', 'Rey Auditory-Verbal Learning Test (RAVLT), the Logical Memory Test, the Stroop Color Test, the Trail Making Test, the Digit Symbol Substitution Test and Inventory of Stress Symptoms (ISSL', 'Side effects', 'Mean adherence', 'presence of sleepiness (Epworth Sleepiness Scale ≥ 10) and/or fatigue (Modified Fatigue Impact Scale ≥ 38) associated with an apnea/hypopnea index (AHI) ≤ 5 and a respiratory disturbance index (RDI) > 5 events/hour of sleep, and/or flow limitation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1319384', 'cui_str': 'Upper airway resistance syndrome'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2091299', 'cui_str': 'Mandibular Advancement Devices'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4505058', 'cui_str': 'Rey Auditory Verbal Learning Test'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0040604', 'cui_str': 'Trail making test'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2733557', 'cui_str': 'Fatigue impact scale'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]",30.0,0.120518,"There was no statistically significant difference in RAVLT, Logical Memory Test, Stroop Color Test, Trail Making Test, Digit Symbol Substitution Test before and after 1.5 years of treatment in both groups.","[{'ForeName': 'Luciana B M', 'Initials': 'LBM', 'LastName': 'de Godoy', 'Affiliation': 'Departamento de Psicobiologia, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ksdy M M', 'Initials': 'KMM', 'LastName': 'Sousa', 'Affiliation': 'Departamento de Psicobiologia, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Luciana de Oliveira', 'Initials': 'LO', 'LastName': 'Palombini', 'Affiliation': 'Departamento de Psicobiologia, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Dalva', 'Initials': 'D', 'LastName': 'Poyares', 'Affiliation': 'Departamento de Psicobiologia, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Cibele', 'Initials': 'C', 'LastName': 'Dal-Fabbro', 'Affiliation': 'Instituto do Sono, São Paulo, Brazil.'}, {'ForeName': 'Thais M', 'Initials': 'TM', 'LastName': 'Guimarães', 'Affiliation': 'Departamento de Psicobiologia, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Tufik', 'Affiliation': 'Departamento de Psicobiologia, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Sonia M', 'Initials': 'SM', 'LastName': 'Togeiro', 'Affiliation': 'Departamento de Psicobiologia, Universidade Federal de São Paulo, São Paulo, Brazil.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8698'] 653,32525235,Continuation Sessions of Mindfulness-Based Cognitive Therapy (MBCT-C) vs. Treatment as Usual in Late-Life Depression and Anxiety: An Open-Label Extension Study.,"OBJECTIVES Mindfulness-based cognitive therapy (MBCT) is a novel treatment for depression. Our published randomized controlled trial shows that MBCT improves symptoms of late-life depression (LLD) and anxiety (LLA). We now examine whether continuation sessions of MBCT (MBCT-C) can prevent LLD/LLA symptom recurrence. METHODS/DESIGN Following an 8-week MBCT intervention, we compared patients who attended open-label weekly 1-hour MBCT-C for another 26 weeks (n = 10) vs those who did not (n = 17) for change in depressive and anxiety symptoms. RESULTS While there were no significant differences between groups on depressive or anxiety symptom severities between 8- and 34- weeks (Cohen's d = 0.045), we observed a small clinical effect of MBCT-C on symptoms of anxiety (d = 0.29). CONCLUSIONS These preliminary results suggest that MBCT-C may be somewhat beneficial for symptoms of LLA, but not for LLD. Healthcare providers should consider what is clinically feasible before investing time and resources into MBCT-C in older adults with depression and/or anxiety.",2020,"While there were no significant differences between groups on depressive or anxiety symptom severities between 8- and 34- weeks (Cohen's d = 0.045), we observed a small clinical effect of MBCT-C on symptoms of anxiety (d = 0.29). ","['Late-Life Depression and Anxiety', 'Older Adults', 'older adults with depression and/or anxiety']","['MBCT', 'MBCT intervention', 'Mindfulness-Based Cognitive Therapy (MBCT-C', 'MBCT (MBCT-C', 'Mindfulness-Based Cognitive Therapy (MBCT']","['depressive or anxiety symptom severities', 'symptoms of anxiety', 'symptoms of late-life depression (LLD) and anxiety (LLA']","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.0552697,"While there were no significant differences between groups on depressive or anxiety symptom severities between 8- and 34- weeks (Cohen's d = 0.045), we observed a small clinical effect of MBCT-C on symptoms of anxiety (d = 0.29). ","[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Dikaios', 'Affiliation': 'McGill Meditation and Mind-Body Medicine Research Clinic (MMMM-RC) and GeriPARTy Research Group, Jewish General Hospital, Montreal, Canada.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Escobar', 'Affiliation': 'McGill Meditation and Mind-Body Medicine Research Clinic (MMMM-RC) and GeriPARTy Research Group, Jewish General Hospital, Montreal, Canada.'}, {'ForeName': 'Marouane', 'Initials': 'M', 'LastName': 'Nassim', 'Affiliation': 'McGill Meditation and Mind-Body Medicine Research Clinic (MMMM-RC) and GeriPARTy Research Group, Jewish General Hospital, Montreal, Canada.'}, {'ForeName': 'Chien-Lin', 'Initials': 'CL', 'LastName': 'Su', 'Affiliation': 'Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Quebec, Canada.'}, {'ForeName': 'Susana G', 'Initials': 'SG', 'LastName': 'Torres-Platas', 'Affiliation': 'McGill Meditation and Mind-Body Medicine Research Clinic (MMMM-RC) and GeriPARTy Research Group, Jewish General Hospital, Montreal, Canada.'}, {'ForeName': 'Soham', 'Initials': 'S', 'LastName': 'Rej', 'Affiliation': 'McGill Meditation and Mind-Body Medicine Research Clinic (MMMM-RC) and GeriPARTy Research Group, Jewish General Hospital, Montreal, Canada.'}]",International journal of geriatric psychiatry,['10.1002/gps.5360'] 654,32530518,"Programmed intermittent epidural bolus vs. patient-controlled epidural analgesia for maintenance of labour analgesia: a two-centre, double-blind, randomised study†.","The programmed intermittent epidural bolus technique has shown superiority to continuous epidural infusion techniques, with or without patient-controlled epidural analgesia for pain relief, reduced motor block and patient satisfaction. Many institutions still use patient-controlled epidural analgesia without a background infusion, and a comparative study between programmed intermittent epidural bolus and patient-controlled epidural analgesia without a background infusion has not yet been performed. We performed a randomised, two-centre, double-blind, controlled trial of these two techniques. The primary outcome was the incidence of breakthrough pain requiring a top-up dose by an anaesthetist. Secondary outcomes included: motor block; pain scores; patient satisfaction; local anaesthetic consumption; and obstetric and neonatal outcomes. We recruited 130 nulliparous women who received initial spinal analgesia, and then epidural analgesia was initiated and maintained with either programmed intermittent epidural bolus or patient-controlled epidural analgesia using ropivacaine 0.12% with sufentanil 0.75 µg·ml -1 . The programmed intermittent epidural bolus group had a programmed bolus of 10 ml every hour, with on-demand patient-controlled epidural analgesia boluses of 5 ml with a 20 min lockout, and the patient-controlled epidural analgesia group had a 5 ml bolus with a 12 min lockout interval; the potential maximum volume per hour was the same in both groups. The patients in the programmed intermittent epidural bolus group had less frequent breakthrough pain compared with the patient-controlled epidural analgesia group, 7 (10.9%) vs. 38 (62.3%; p < 0.0001), respectively. There was a significant difference in motor block (modified Bromage score ≤ 4) frequency between groups, programmed intermittent epidural bolus group 1 (1.6%) vs. patient-controlled epidural analgesia group 8 (13.1%); p = 0.015. The programmed intermittent epidural bolus group had greater local anaesthetic consumption with fewer patient-controlled epidural analgesia boluses. Patient satisfaction scores and obstetric or neonatal outcomes were not different between groups. In conclusion, we found that a programmed intermittent epidural bolus technique using 10 ml programmed boluses and 5 ml patient-controlled epidural analgesia boluses was superior to a patient-controlled epidural analgesia technique using 5 ml boluses and no background infusion.",2020,"The patients in the programmed intermittent epidural bolus group had less frequent breakthrough pain compared with the patient-controlled epidural analgesia group, 7 (10.9%) vs. 38 (62.3%; p < 0.0001), respectively.",['130 nulliparous women who received'],"['initial spinal analgesia, and then epidural analgesia was initiated and maintained with either programmed intermittent epidural bolus or patient-controlled epidural analgesia using ropivacaine 0.12% with sufentanil 0.75\xa0µg·ml -1 ', 'Programmed intermittent epidural bolus vs. patient-controlled epidural analgesia']","['motor block; pain scores; patient satisfaction; local anaesthetic consumption; and obstetric and neonatal outcomes', 'motor block', 'local anaesthetic consumption', 'Patient satisfaction scores and obstetric or neonatal outcomes', 'incidence of breakthrough pain requiring a top-up dose by an anaesthetist', 'frequent breakthrough pain']","[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1963862', 'cui_str': 'Spinal analgesia'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C1301707', 'cui_str': 'Patient controlled epidural analgesia'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C4517426', 'cui_str': '0.12'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C4068882', 'cui_str': '0.75'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1135120', 'cui_str': 'Breakthrough pain'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}]",130.0,0.136129,"The patients in the programmed intermittent epidural bolus group had less frequent breakthrough pain compared with the patient-controlled epidural analgesia group, 7 (10.9%) vs. 38 (62.3%; p < 0.0001), respectively.","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Roofthooft', 'Affiliation': 'Department of Anaesthesiology, GZA Sint Augustinus Hospital, Antwerp, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Barbé', 'Affiliation': 'Department of Anaesthesiology, University Hospitals Leuven, Belgium.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Schildermans', 'Affiliation': 'Department of Anaesthesiology, University Hospitals Leuven, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cromheecke', 'Affiliation': 'Department of Anaesthesiology, ZNA Middelheim Hospital, Antwerp, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Devroe', 'Affiliation': 'Department of Cardiovascular Sciences, KU Leuven, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Fieuws', 'Affiliation': 'Department of I-Biostat, KU Leuven, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rex', 'Affiliation': 'Department of Cardiovascular Sciences, KU Leuven, Belgium.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Wong', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Van de Velde', 'Affiliation': 'Department of Cardiovascular Sciences, KU Leuven, Belgium.'}]",Anaesthesia,['10.1111/anae.15149'] 655,32526606,Choosing vaginal birth after caesarean section: Motivating factors.,"OBJECTIVES to examine the factors that motivate women who have had a previous caesarean section to consider planning a vaginal birth. DESIGN a qualitative descriptive study with thematic analysis, drawing on interviews with women participating in a two arm, un-blinded randomised controlled trial (RCT) of midwifery continuity of care for increasing the proportion of women planning VBAC. SETTING A Maternity Unit attached to a district hospital in an outer metropolitan area of Sydney, Australia. PARTICIPANTS a purposive sample of 18 women participating in an RCT who had experienced previous caesarean section and had no contraindications for vaginal birth. FINDINGS These women were committed to natural birth and drew on their previous experience of caesarean section to highlight the downside of recovery post caesarean section. Decision making for these women was complex. During the decision-making process, women individualised the information provided to balance risk and chance within the context of their own circumstance. Supportive healthcare providers were important in motivating women towards vaginal birth and midwives were identified as being more supportive than obstetricians. CONCLUSIONS Recovery post caesarean section is an important consideration that is under emphasised in the informed consent process. There is opportunity for midwives to contribute proactively in promoting vaginal birth for women who have experienced a previous caesarean section. IMPLICATIONS FOR PRACTICE women should be assisted to make informed choices with balanced information that includes recovery from surgical birth. Models of care that include a significant role for midwives and strategies that proactively encourage vaginal birth for women after previous caesarean section are needed.",2020,"Supportive healthcare providers were important in motivating women towards vaginal birth and midwives were identified as being more supportive than obstetricians. ","['A Maternity Unit attached to a district hospital in an outer metropolitan area of Sydney, Australia', 'a purposive sample of 18 women participating in an RCT who had experienced previous caesarean section and had no contraindications for vaginal birth', 'motivate women who have had a previous caesarean section to consider planning a vaginal birth', 'women who have experienced a previous caesarean section']",[],[],"[{'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0020006', 'cui_str': 'District hospital'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0269733', 'cui_str': 'Previous caesarean section'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]",[],[],18.0,0.0830958,"Supportive healthcare providers were important in motivating women towards vaginal birth and midwives were identified as being more supportive than obstetricians. ","[{'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Davis', 'Affiliation': 'University of Canberra and ACT Government Health Directorate, Faculty of Health, Bruce, 2617, ACT, Australia. Electronic address: Deborah.davis@canberra.edu.au.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'S Homer', 'Affiliation': 'Maternal and Child Health Program, Burnet Institute, Melbourne, Australia; Centre for Midwifery, Child and Family Health, Faculty of Health, University of Technology Sydney, Australia.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Clack', 'Affiliation': 'Centre for Midwifery, Child and Family Health, Faculty of Health, University of Technology Sydney, Australia.'}, {'ForeName': 'Sabera', 'Initials': 'S', 'LastName': 'Turkmani', 'Affiliation': 'Centre for Midwifery, Child and Family Health, Faculty of Health, University of Technology Sydney, Australia.'}, {'ForeName': 'Maralyn', 'Initials': 'M', 'LastName': 'Foureur', 'Affiliation': 'Centre for Midwifery, Child and Family Health, Faculty of Health, University of Technology Sydney, Australia; Hunter New England Local Health District & University of Newcastle, NSW, Australia.'}]",Midwifery,['10.1016/j.midw.2020.102766'] 656,32536440,Effect of Mozart K.448 on interictal epileptiform discharges in children with epilepsy: A randomized controlled pilot study.,"BACKGROUND Epilepsy is a common pediatric neurologic disease in Thailand. However, the mainstay antiepileptic pharmacotherapies can induce severe side effects. While the benefit of playing Mozart K.448 music has been studied as an alternative, supplementary, nonpharmacologic treatment for epilepsy, the literature features limited few randomized controlled trial studies of children. OBJECTIVE We aimed to study the effect of Mozart K.448 for two pianos on interictal epileptiform discharges (IEDs), quantitative electroencephalogram (qEEG), and heart rate variability (HRV) in patients with epilepsy. METHODS We employed a single-blinded randomized trial design with a placebo control. The treatment group listened to the first 8 min of Mozart K.448 for two pianos during EEG recording. The control group underwent an EEG recording of the same duration in a quiet environment. Interictal epileptiform discharges were manually counted for 8 min before, during, and after the song was plated. Quantitative electroencephalogram and HRV were analyzed in each period. RESULT A total of 32 patients aged 0-18 years were enrolled. There were 12 patients in the music group and 14 patients in the control group; 67% of the patients in the former exhibited significantly decreased IEDs while listening to the music compared with 42% of the patients in the quiet group (RR [Relative Risk Reduction]: 0.72, p-value: <0.001, 95% confidence interval [CI]: 0.69-0.74). During music exposure, qEEG demonstrated an increase in the delta/theta to alpha/beta ratio relative to that of controls (median in music: +3% and control: -6%, p-value: 0.520). Heart rate variability analyses showed a decrease in the ratio of low frequency to high frequency (LF/HF), which represents parasympathetic activity during music exposure (decrease of 34%, p-value: 0.382). CONCLUSION The present study showed that Mozart K.448 reduced the number of IEDs in children with epilepsy and that Mozart K.448 could enhance parasympathetic activity. However, possibly because of the small study population, statistical significance was not reached. Our study revealed the considerable potential of music in the treatment of pediatric epilepsy.",2021,"Heart rate variability analyses showed a decrease in the ratio of low frequency to high frequency (LF/HF), which represents parasympathetic activity during music exposure (decrease of 34%, p-value: 0.382). ","['pediatric epilepsy', 'patients with epilepsy', '32 patients aged 0-18\u202fyears were enrolled', 'children with epilepsy']","['placebo', 'Mozart K.448']","['interictal epileptiform discharges', 'number of IEDs', 'Quantitative electroencephalogram and HRV', 'parasympathetic activity during music exposure', 'interictal epileptiform discharges (IEDs), quantitative electroencephalogram (qEEG), and heart rate variability (HRV', 'severe side effects', 'parasympathetic activity', 'Interictal epileptiform discharges', 'delta/theta to alpha/beta ratio relative', 'IEDs while listening to the music']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}]",32.0,0.224274,"Heart rate variability analyses showed a decrease in the ratio of low frequency to high frequency (LF/HF), which represents parasympathetic activity during music exposure (decrease of 34%, p-value: 0.382). ","[{'ForeName': 'Tanitnun', 'Initials': 'T', 'LastName': 'Paprad', 'Affiliation': 'Division of Pediatric Neurology, Department of Pediatrics, King Chulalongkorn Memorial Hospital/Thai Red Cross Society, Thailand.'}, {'ForeName': 'Montida', 'Initials': 'M', 'LastName': 'Veeravigrom', 'Affiliation': 'Division of Pediatric Neurology, Department of Pediatrics, King Chulalongkorn Memorial Hospital/Thai Red Cross Society, Thailand; Division of Pediatric Neurology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Thailand. Electronic address: montida.v@chula.ac.th.'}, {'ForeName': 'Tayard', 'Initials': 'T', 'LastName': 'Desudchit', 'Affiliation': 'Division of Pediatric Neurology, Department of Pediatrics, King Chulalongkorn Memorial Hospital/Thai Red Cross Society, Thailand; Division of Pediatric Neurology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Thailand.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107177'] 657,32550188,Adverse effects of honey on low-density lipoprotein cholesterol and adiponectin concentrations in patients with type 2 diabetes: a randomized controlled cross-over trial.,"Background Due to phenolic and fructose content, honey may be a suitable sweetener for patients with type 2 diabetes. However, its effect on oxidative and inflammatory status of diabetes patients is not clear. We aimed to investigate the effect of natural honey on some of oxidative, inflammatory, and anti-inflammatory markers of patients with type 2 diabetes. Methods In a randomized controlled cross-over trial, 43 patients with type 2 diabetes were allocated to isocaloric conditions with either dietary recommendations (control) or natural honey (50 g/day) plus dietary recommendations (honey) for 8 weeks with one month washout period in between. Serum lipids, malondialdehyde (MDA), total antioxidant capacity (TAC), high-sensitivity C-reactive protein (hs-CRP), and adiponectin levels were measured at baseline and the end of each sequence. Results Malondialdehyde (10.9%, P = 0.01), hs-C reactive protein (10.6%, P = 0.003), and adiponectin (7.1%, P < 0.001) concentrations significantly decreased in honey condition. Low-density lipoprotein cholesterol (LDL-C) (16.8%, P < 0.001) significantly decreased in control and high-density lipoprotein cholesterol (HDL-C) significantly increased in both conditions. Between-group differences were only statistically significant for adiponectin (P = 0.005) and LDL-C (P = 0.005). Conclusions Consumption of 50 g/day honey had adverse effects on LDL-C and adiponectin levels in patients with type 2 diabetes. Honey may need to be consumed with caution in type 2 diabetes patients.",2020,"Results Malondialdehyde (10.9%, P = 0.01), hs-C reactive protein (10.6%, P = 0.003), and adiponectin (7.1%, P < 0.001) concentrations significantly decreased in honey condition.","['type 2 diabetes patients', 'diabetes patients', '43 patients with type 2 diabetes', 'patients with type 2 diabetes']",['isocaloric conditions with either dietary recommendations (control) or natural honey (50 g/day) plus dietary recommendations (honey'],"['control and high-density lipoprotein cholesterol (HDL-C', 'adiponectin', 'Serum lipids, malondialdehyde (MDA), total antioxidant capacity (TAC), high-sensitivity C-reactive protein (hs-CRP), and adiponectin levels', 'hs-C reactive protein', 'Low-density lipoprotein cholesterol (LDL-C', 'LDL-C', 'low-density lipoprotein cholesterol and adiponectin concentrations', 'LDL-C and adiponectin levels']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0019906', 'cui_str': 'Honey'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",43.0,0.134278,"Results Malondialdehyde (10.9%, P = 0.01), hs-C reactive protein (10.6%, P = 0.003), and adiponectin (7.1%, P < 0.001) concentrations significantly decreased in honey condition.","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Sadeghi', 'Affiliation': 'School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Razi Blvd, Shiraz, Iran.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Akhlaghi', 'Affiliation': 'School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Razi Blvd, Shiraz, Iran.'}, {'ForeName': 'Saedeh', 'Initials': 'S', 'LastName': 'Salehi', 'Affiliation': 'School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Razi Blvd, Shiraz, Iran.'}]",Journal of diabetes and metabolic disorders,['10.1007/s40200-020-00518-z'] 658,32553471,Tubal flushing with oil-based or water-based contrast at hysterosalpingography for infertility: long-term reproductive outcomes of a randomized trial.,"OBJECTIVE To determine the impact of oil-based versus water-based contrast on pregnancy and live birth rates ≤5 years after hysterosalpingography (HSG) in infertile women. DESIGN A 5-year follow-up study of a multicenter randomized trial. SETTING Hospitals. PATIENT(S) Infertile women with an ovulatory cycle, 18-39 years of age, and having a low risk of tubal pathology. INTERVENTION(S) Use of oil-based versus water-based contrast during HSG. MAIN OUTCOME MEASURE(S) Ongoing pregnancy, live births, time to ongoing pregnancy, second ongoing pregnancy. RESULT(S) A total of 1,119 women were randomly assigned to HSG with oil-based contrast (n = 557) or water-based contrast (n = 562). After 5 years, 444 of 555 women in the oil group (80.0%) and 419 of 559 women in the water group (75.0%) had an ongoing pregnancy (relative risk [RR] 1.07; 95% confidence interval [CI] 1.00-1.14), and 415 of 555 women in the oil group (74.8%) and 376 of 559 women in the water group (67.3%) had live births (RR 1.11; 95% CI 1.03-1.20). In the oil group, 228 pregnancies (41.1%) were conceived naturally versus 194 (34.7%) pregnancies in the water group (RR 1.18; 95% CI 1.02-1.38). The time to ongoing pregnancy was significantly shorter in the oil group versus the water group (10.0 vs. 13.7 months; hazard ratio, 1.25; 95% CI 1.09-1.43). No difference was found in the occurrence of a second ongoing pregnancy. CONCLUSION(S) During a 5-year time frame, ongoing pregnancy and live birth rates are higher after tubal flushing with oil-based contrast during HSG compared with water-based contrast. More pregnancies are naturally conceived and time to ongoing pregnancy is shorter after HSG with oil-based contrast. CLINICAL TRIAL REGISTRATION NUMBER Netherlands Trial Register (NTR) 3270 and NTR6577(www.trialregister.nl).",2020,"The time to ongoing pregnancy was significantly shorter in the oil group versus the water group (10.0 vs. 13.7 months; hazard ratio, 1.25; 95% CI 1.09-1.43).","['infertile women', 'A total of 1,119 women', '\n\n\nInfertile women with an ovulatory cycle, 18-39 years of age, and having a low risk of tubal pathology', 'Hospitals']","['hysterosalpingography (HSG', 'Tubal flushing with oil-based or water-based contrast at hysterosalpingography', 'oil-based versus water-based contrast during HSG', 'oil-based versus water-based contrast', 'HSG with oil-based contrast (n = 557) or water-based contrast']","['time to ongoing pregnancy', 'ongoing pregnancy', 'occurrence of a second ongoing pregnancy', 'live births', '5-year time frame, ongoing pregnancy and live birth rates']","[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}, {'cui': 'C4285925', 'cui_str': 'Tubal flushing'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332168', 'cui_str': 'Time frame'}]",1119.0,0.17144,"The time to ongoing pregnancy was significantly shorter in the oil group versus the water group (10.0 vs. 13.7 months; hazard ratio, 1.25; 95% CI 1.09-1.43).","[{'ForeName': 'Joukje', 'Initials': 'J', 'LastName': 'van Rijswijk', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands. Electronic address: j.vanrijswijk@amsterdamumc.nl.'}, {'ForeName': 'Nienke', 'Initials': 'N', 'LastName': 'van Welie', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Dreyer', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Clarabelle T', 'Initials': 'CT', 'LastName': 'Pham', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, Victoria, Australia.'}, {'ForeName': 'Harold R', 'Initials': 'HR', 'LastName': 'Verhoeve', 'Affiliation': 'Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis, Amsterdam; the Netherlands.'}, {'ForeName': 'Annemieke', 'Initials': 'A', 'LastName': 'Hoek', 'Affiliation': 'Department of Reproductive Medicine and Gynaecology, University of Groningen, University Medical Centre Groningen, Hanzeplein, the Netherlands.'}, {'ForeName': 'Jan Peter', 'Initials': 'JP', 'LastName': 'de Bruin', 'Affiliation': 'Department of Obstetrics and Gynaecology, Jeroen Bosch Hospital, Hertogenbosch, the Netherlands.'}, {'ForeName': 'Annemiek W', 'Initials': 'AW', 'LastName': 'Nap', 'Affiliation': 'Department of Obstetrics and Gynaecology, Rijnstate Hospital, Arnhem, the Netherlands.'}, {'ForeName': 'Machiel H A', 'Initials': 'MHA', 'LastName': 'van Hooff', 'Affiliation': 'Department of Obstetrics and Gynaecology, Franciscus Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'Mariëtte', 'Initials': 'M', 'LastName': 'Goddijn', 'Affiliation': 'Centre for Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Angelo B', 'Initials': 'AB', 'LastName': 'Hooker', 'Affiliation': 'Department of Obstetrics and Gynaecology, Zaans Medical Centre, Zaandam, the Netherlands.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Bourdrez', 'Affiliation': 'Department of Obstetrics and Gynaecology, VieCuri Medical Centre, Venlo, the Netherlands.'}, {'ForeName': 'Angelique J C M', 'Initials': 'AJCM', 'LastName': 'van Dongen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hospital Gelderse Vallei, Ede, the Netherlands.'}, {'ForeName': 'Ilse A J', 'Initials': 'IAJ', 'LastName': 'van Rooij', 'Affiliation': 'Department of Obstetrics and Gynaecology, Elisabeth-TweeSteden Hospital, Tilburg, the Netherlands.'}, {'ForeName': 'Henrike G M', 'Initials': 'HGM', 'LastName': 'van Rijnsaardt-Lukassen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Albert Schweitzer Hospital, Dordrecht, the Netherlands.'}, {'ForeName': 'Ron J T', 'Initials': 'RJT', 'LastName': 'van Golde', 'Affiliation': 'Department of Obstetrics and Gynaecology, Maastricht UMC, Maastricht, the Netherlands.'}, {'ForeName': 'Cathelijne F', 'Initials': 'CF', 'LastName': 'van Heteren', 'Affiliation': 'Department of Obstetrics and Gynaecology, Canisius Wilhelmina Hospital, Nijmegen, the Netherlands.'}, {'ForeName': 'Marie J', 'Initials': 'MJ', 'LastName': 'Pelinck', 'Affiliation': 'Department of Obstetrics and Gynaecology, Scheper Hospital, Emmen, the Netherlands.'}, {'ForeName': 'Annette E J', 'Initials': 'AEJ', 'LastName': 'Duijn', 'Affiliation': 'Vrouwenkliniek Zuidoost, Amsterdam, the Netherlands.'}, {'ForeName': 'Mesrure', 'Initials': 'M', 'LastName': 'Kaplan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Röpcke-Zweers Hospital, Hardenberg, the Netherlands.'}, {'ForeName': 'Cornelis B', 'Initials': 'CB', 'LastName': 'Lambalk', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Velja', 'Initials': 'V', 'LastName': 'Mijatovic', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Ben W J', 'Initials': 'BWJ', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Clayton, Victoria, Australia.'}]",Fertility and sterility,['10.1016/j.fertnstert.2020.03.022'] 659,32554999,Hip Resurfacing Compared with 28-mm Metal-on-Metal Total Hip Replacement: A Randomized Study with 15 Years of Follow-up.,"BACKGROUND Bone stock conservation, hip anatomy preservation, and greater stability are among the promoted advantages of hip resurfacing (HR). However, the disappointing failure of some implants nearly led to its abandonment. The aim of this study was to compare clinical scores and revision and complication rates after HR with those after total hip arthroplasty (THA). METHODS Two hundred and three hips were randomized to 28-mm metal-on-metal (MoM) THA (99 hips) or to HR (104 hips). Main outcome measures compared between groups were the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, the revision rate, and the complication rates. The radiographic findings were also assessed. RESULTS After a mean follow-up of 15 years (range, 14 to 16 years), 9 (4.4%) of the 203 patients were lost to follow-up and 15 (7.4%) had died. The Kaplan-Meier survivorship, with revision for any reason as the end point, was 89.2% (95% confidence interval [CI], 82.3% to 96.1%) for HR and 94.2% (95% CI, 89.3% to 99.1%) for THA (p = 0.292). The reasons for revision included infection (3 patients), recurrent dislocation (1 patient), and adverse reaction to metal debris (ARMD) (1 patient) in the THA group and ARMD (2 patients) and femoral head loosening (7 patients) in the HR group. With aseptic revision as the end point, the Kaplan-Meier survivorship was significantly higher in the THA group (97.4% versus 89.2%; p = 0.033). No dislocation occurred in the HR group compared with 4 in the THA group (p = 0.058). Both groups achieved a similar mean WOMAC score (10.7 in the HR group and 8.8 in the THA group; p = 0.749), Forgotten Joint Score (87.1 and 85.3, respectively; p = 0.410), University of California Los Angeles (UCLA) activity score (6.3 and 6.4, respectively; p = 0.189), and overall joint perception (p = 0.251). CONCLUSIONS The specific HR and MoM 28-mm THA implants used in this study showed good long-term survival and function. The overall rates of complications and revisions were similar in both groups but were of different types. As it provides better femoral bone preservation and biomechanical reconstruction, HR may continue to have a role in selected patients when performed by experienced surgeons and using validated implants. LEVEL OF EVIDENCE Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"With aseptic revision as the end point, the Kaplan-Meier survivorship was significantly higher in the THA group (97.4% versus 89.2%; p = 0.033).","['Two hundred and three hips', '15 Years of Follow-up']","['THA', '28-mm metal-on-metal (MoM', '28-mm Metal-on-Metal Total Hip Replacement', 'Hip Resurfacing', 'total hip arthroplasty (THA']","['University of California Los Angeles (UCLA) activity score', 'overall rates of complications and revisions', 'mean WOMAC score', 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, the revision rate, and the complication rates', 'recurrent dislocation (1 patient), and adverse reaction to metal debris (ARMD', 'Kaplan-Meier survivorship', 'clinical scores and revision and complication rates', 'died', 'good long-term survival and function', 'overall joint perception', 'Forgotten Joint Score', 'No dislocation']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}]","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0158100', 'cui_str': 'Recurrent dislocation of joint'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0440266', 'cui_str': 'Debris'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C4759288', 'cui_str': 'Forgotten Joint Score'}, {'cui': 'C0012691', 'cui_str': 'Dislocation'}]",203.0,0.128028,"With aseptic revision as the end point, the Kaplan-Meier survivorship was significantly higher in the THA group (97.4% versus 89.2%; p = 0.033).","[{'ForeName': 'Pascal-André', 'Initials': 'PA', 'LastName': 'Vendittoli', 'Affiliation': 'Surgery Department, Hôpital Maisonneuve-Rosemont, Montreal University, Montréal, Québec, Canada.'}, {'ForeName': 'Maged', 'Initials': 'M', 'LastName': 'Shahin', 'Affiliation': 'Surgery Department, Hôpital Maisonneuve-Rosemont, Montreal University, Montréal, Québec, Canada.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Rivière', 'Affiliation': 'MSK Lab-Imperial College London, London, United Kingdom.'}, {'ForeName': 'Alain Guy', 'Initials': 'AG', 'LastName': 'Roy', 'Affiliation': 'Surgery Department, Hôpital Maisonneuve-Rosemont, Montreal University, Montréal, Québec, Canada.'}, {'ForeName': 'Janie', 'Initials': 'J', 'LastName': 'Barry', 'Affiliation': 'Surgery Department, Hôpital Maisonneuve-Rosemont, Montreal University, Montréal, Québec, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lavigne', 'Affiliation': 'Surgery Department, Hôpital Maisonneuve-Rosemont, Montreal University, Montréal, Québec, Canada.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.20.00030'] 660,32560639,Combination of Ranibizumab with macular laser for macular edema secondary to branch retinal vein occlusion: one-year results from a randomized controlled double-blind trial.,"BACKGROUND It is not clear whether macular laser combined with anti-vascular endothelial growth factor (VEGF) can reduce the number of anti-VEGF injections in the treatment of macular edema (ME) secondary to branch retinal vein occlusion (BRVO). Our study aimed to investigate the effects of intravitreal ranibizumab with or without macular laser for ME secondary to BRVO and its associated number of anti-VEGF injections. METHODS This is a prospective, randomized, double-blind, monocentric trial.80 patients were enrolled and 64 patients fulfilled the study requirements. All patients received a minimum of 3 initial monthly ranibizumab injections, pro re nata (PRN) dosing thereafter VA and CRT stabilization criteria-driven PRN treatment. Laser was given 7 days after third ranibizumab injection in ranibizumab with laser group. The follow-up time of this study was 1 year. Best corrected visual acuity (BCVA) improvement, central retinal thickness (CRT) reduction and number of injections of patients were compared between two groups. T-test, non-parametric Wilcoxon test and chis-square tests were adopted for between-group comparisons. RESULTS Thirty patients received intravitreal ranibizumab 0.5 mg alone and 34 patients received intravitreal ranibizumab 0.5 mg with macular laser. At 52 week, BCVA increased significantly and CRT decreased significantly in both groups (P < 0.001). However, there was no significant difference in BCVA improvement with baseline BCVA adjusted (p = 0.5226), and in the CRT reduction (P = 0.4552) between two groups after 52 weeks. There was also no significant difference in the number of injections between the two groups. (P = 0.0756). There was also no significant difference between ischemic and non-ischemic groups in BCVA improvement, CRT reduction and number of injections (P > 0.05). CONCLUSIONS Our study suggests that ranibizumab combined with macular laser is effective in the treatment of ME secondary to BRVO after 1 year of treatment with 3 + PRN regimen. However, combination of macular grid photocoagulation showed no beneficial anatomical or functional effect during follow-up period, nor did it reduce the number of ranibizumab injections, either in ischemic group or non-ischemic group. We suggest that there is no need to combine macular grid photocoagulation in the treatment of ME secondary to BRVO in the future. TRIAL REGISTRATION Clinical Trials NCT03054766. https://register.clinicaltrials.gov.Prospectively registered.",2020,"At 52 week, BCVA increased significantly and CRT decreased significantly in both groups (P < 0.001).","['monocentric trial.80 patients were enrolled and 64 patients fulfilled the study requirements', 'macular edema secondary to branch retinal vein occlusion']","['macular grid photocoagulation', 'intravitreal ranibizumab 0.5\u2009mg with macular laser', 'ranibizumab', 'Ranibizumab with macular laser', 'ranibizumab injection in ranibizumab with laser group', 'ranibizumab injections, pro re nata (PRN', 'intravitreal ranibizumab', 'macular laser combined with anti-vascular endothelial growth factor (VEGF']","['BCVA improvement, CRT reduction and number of injections', 'BCVA improvement', 'BCVA increased significantly and CRT', 'Best corrected visual acuity (BCVA) improvement, central retinal thickness (CRT) reduction and number of injections', 'beneficial anatomical or functional effect', 'CRT reduction', 'number of injections', 'T-test, non-parametric Wilcoxon test and chis-square tests']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0339505', 'cui_str': 'Venous retinal branch occlusion'}]","[{'cui': 'C1302035', 'cui_str': 'Grid photocoagulation'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C4050112', 'cui_str': 'ranibizumab Injection'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0067792', 'cui_str': 'N-acetyltryptophanamide'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205120', 'cui_str': 'Square'}]",,0.264013,"At 52 week, BCVA increased significantly and CRT decreased significantly in both groups (P < 0.001).","[{'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Song', 'Affiliation': ""Department of Ophthalmology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.""}, {'ForeName': 'Xiaobing', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': ""Department of Ophthalmology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People's Republic of China. yuxiaobing1214@163.com.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': ""Department of Ophthalmology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.""}, {'ForeName': 'Xiaoya', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': ""Department of Ophthalmology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Dai', 'Affiliation': ""Department of Ophthalmology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.""}]",BMC ophthalmology,['10.1186/s12886-020-01498-7'] 661,32562721,Lower Adenoma Miss Rate of Computer-Aided Detection-Assisted Colonoscopy vs Routine White-Light Colonoscopy in a Prospective Tandem Study.,"BACKGROUND AND AIMS Up to 30% of adenomas might be missed during screening colonoscopy-these could be polyps that appear on-screen but are not recognized by endoscopists or polyps that are in locations that do not appear on the screen at all. Computer-aided detection (CADe) systems, based on deep learning, might reduce rates of missed adenomas by displaying visual alerts that identify precancerous polyps on the endoscopy monitor in real time. We compared adenoma miss rates of CADe colonoscopy vs routine white-light colonoscopy. METHODS We performed a prospective study of patients, 18-75 years old, referred for diagnostic, screening, or surveillance colonoscopies at a single endoscopy center of Sichuan Provincial People's Hospital from June 3, 2019 through September 24, 2019. Same day, tandem colonoscopies were performed for each participant by the same endoscopist. Patients were randomly assigned to groups that received either CADe colonoscopy (n=184) or routine colonoscopy (n=185) first, followed immediately by the other procedure. Endoscopists were blinded to the group each patient was assigned to until immediately before the start of each colonoscopy. Polyps that were missed by the CADe system but detected by endoscopists were classified as missed polyps. False polyps were those continuously traced by the CADe system but then determined not to be polyps by the endoscopists. The primary endpoint was adenoma miss rate, which was defined as the number of adenomas detected in the second-pass colonoscopy divided by the total number of adenomas detected in both passes. RESULTS The adenoma miss rate was significantly lower with CADe colonoscopy (13.89%; 95% CI, 8.24%-19.54%) than with routine colonoscopy (40.00%; 95% CI, 31.23%-48.77%, P<.0001). The polyp miss rate was significantly lower with CADe colonoscopy (12.98%; 95% CI, 9.08%-16.88%) than with routine colonoscopy (45.90%; 95% CI, 39.65%-52.15%) (P<.0001). Adenoma miss rates in ascending, transverse, and descending colon were significantly lower with CADe colonoscopy than with routine colonoscopy (ascending colon 6.67% vs 39.13%; P=.0095; transverse colon 16.33% vs 45.16%; P=.0065; and descending colon 12.50% vs 40.91%, P=.0364). CONCLUSIONS CADe colonoscopy reduced the overall miss rate of adenomas by endoscopists using white-light endoscopy. Routine use of CADe might reduce the incidence of interval colon cancers. chictr.org.cn study no: ChiCTR1900023086.",2020,"The polyp miss rate significantly lower with CADe colonoscopy (12.98%; 95% CI, 9.08%-16.88%) than with routine colonoscopy (45.90%; 95% CI, 39.65%-52.15%) (P<.0001).","[""patients, 18-75 years old, referred for diagnostic, screening, or surveillance colonoscopies at a single endoscopy center of Sichuan Provincial People's Hospital from June 3, 2019 through September 24, 2019""]","['CADe colonoscopy', 'Computer-aided Detection-Assisted Colonoscopy vs Routine White-Light Colonoscopy', 'CADe colonoscopy (n=184) or routine colonoscopy', 'CADe colonoscopy vs routine white-light colonoscopy', 'CADe']","['adenoma miss rate', 'Adenoma miss rates in ascending, transverse, and descending colon', 'incidence of interval colon cancers']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0563228', 'cui_str': 'White light'}]","[{'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0227389', 'cui_str': 'Descending colon structure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}]",,0.0444084,"The polyp miss rate significantly lower with CADe colonoscopy (12.98%; 95% CI, 9.08%-16.88%) than with routine colonoscopy (45.90%; 95% CI, 39.65%-52.15%) (P<.0001).","[{'ForeName': 'Pu', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Peixi', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Jeremy R', 'Initials': 'JR', 'LastName': 'Glissen Brown', 'Affiliation': 'Center for Advanced Endoscopy, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Tyler M', 'Initials': 'TM', 'LastName': 'Berzin', 'Affiliation': 'Center for Advanced Endoscopy, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Guanyu', 'Initials': 'G', 'LastName': 'Zhou', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Lei', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Xiaogang', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Liangping', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China. Electronic address: xiaoxun001@outlook.com.""}]",Gastroenterology,['10.1053/j.gastro.2020.06.023'] 662,32567869,Longitudinal effects of psychotherapy with transgender and nonbinary clients: A randomized controlled pilot trial.,"Minority stress has been determined to contribute to some mental health concerns for transgender, nonbinary, and gender nonconforming individuals, yet little is known regarding interventions to decrease the effects of minority stress. The purpose of this pilot study was to assess the feasibility and relative effectiveness of two interventions developed for work with transgender clients. Transgender individuals ( N = 20) were recruited to participate in a randomized controlled trial comparing two psychotherapy interventions for transgender adults seeking psychotherapy for a variety of concerns: (a) transgender affirmative psychotherapy (TA) and (b) Building Awareness of Minority Stressors + Transgender Affirmative psychotherapy. Gender-related stress and resilience were assessed before, immediately after, and 6 months following the intervention; psychological distress and working alliance were assessed at these three time points as well as weekly during the intervention. Feasibility and acceptability of the study and psychotherapy interventions were supported. Exploratory analyses indicate improvement in both groups based on general outcome measures; targeted outcome measures indicate a trend of improvement for internalized stigma and nonaffirmation experiences. Results from this study support further evaluation of both treatment arms in a larger randomized controlled trial. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,Exploratory analyses indicate improvement in both groups based on general outcome measures; targeted outcome measures indicate a trend of improvement for internalized stigma and nonaffirmation experiences.,"['Transgender individuals ( N = 20', 'and nonbinary clients']","['psychotherapy interventions for transgender adults seeking psychotherapy for a variety of concerns: (a) transgender affirmative psychotherapy (TA) and (b) Building Awareness of Minority Stressors + Transgender Affirmative psychotherapy', 'psychotherapy with transgender']","['psychological distress and working alliance', 'internalized stigma and nonaffirmation experiences', 'feasibility and relative effectiveness', 'Feasibility and acceptability']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008942', 'cui_str': 'Clients'}]","[{'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0558141', 'cui_str': 'Transsexual'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",20.0,0.0655726,Exploratory analyses indicate improvement in both groups based on general outcome measures; targeted outcome measures indicate a trend of improvement for internalized stigma and nonaffirmation experiences.,"[{'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Budge', 'Affiliation': 'Department of Counseling Psychology.'}, {'ForeName': 'Morgan T', 'Initials': 'MT', 'LastName': 'Sinnard', 'Affiliation': 'Department of Counseling Psychology.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Hoyt', 'Affiliation': 'Department of Counseling Psychology.'}]","Psychotherapy (Chicago, Ill.)",['10.1037/pst0000310'] 663,32453275,TAS2R38 Haplotype Predicts 24-Hour Urinary Sodium Excretion in Patients With Heart Failure and Their Family Caregivers.,"BACKGROUND Adherence to a low-sodium diet is essential to self-care of heart failure (HF). Genetic determinants of preference for high-sodium foods may impede adherence but have not been well-studied. OBJECTIVE Our purpose was to examine if TAS2R38 haplotype predicted salt taste sensitivity and dietary sodium intake among patients with HF. METHOD This pilot study used baseline data from a large interventional randomized control trial to support adherence to a low-sodium diet in patients with HF and their family caregivers. Participants were tested for salt taste sensitivity and provided a 24-hour urinary sodium sample and a blood sample for DNA analysis at baseline. Fungiform papillae were counted. χ2 Test and 1-way analysis of variance were used to compare haplotype groups. Linear regression was performed to examine predictors of salt taste sensitivity and 24-hour urinary sodium excretion, controlling for age, gender, ethnicity, smoking status, and fungiform papillae density. RESULTS There were 42 patients with HF and their family caregivers (age, 64.6 ± 13.4 years, 46.5% male, 97.7% white, and 90.7% nonsmoker). Pronine-alanine-valine homozygous haplotype predicted lower urinary sodium excretion (b = -1780.59, t41 = -2.18, P = .036), but genotype was not a significant predictor of salt taste sensitivity. CONCLUSIONS The results of our study partially supported our hypothesis that PAV homozygous haplotype predicts 24-hour urinary sodium excretion. With our small sample size, more research is needed. Understanding genetic influences on taste can lead to development of educational interventions tailored to patients with HF and their family caregivers to better support dietary adherence.",2021,"Pronine-alanine-valine homozygous haplotype predicted lower urinary sodium excretion (b = -1780.59, t41 = -2.18, P = .036), but genotype was not a significant predictor of salt taste sensitivity. ","['patients with HF', '42 patients with HF and their family caregivers (age, 64.6 ± 13.4 years, 46.5% male, 97.7% white, and 90.7% nonsmoker', 'Patients With Heart Failure and Their Family Caregivers', 'patients with HF and their family caregivers']",['low-sodium diet'],"['salt taste sensitivity and 24-hour urinary sodium excretion, controlling for age, gender, ethnicity, smoking status, and fungiform papillae density', 'urinary sodium excretion', '24-hour urinary sodium excretion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517558', 'cui_str': '13.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}]","[{'cui': 'C0012169', 'cui_str': 'Low sodium diet'}]","[{'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0226968', 'cui_str': 'Structure of fungiform papillae of tongue'}, {'cui': 'C0178587', 'cui_str': 'Density'}]",42.0,0.028638,"Pronine-alanine-valine homozygous haplotype predicted lower urinary sodium excretion (b = -1780.59, t41 = -2.18, P = .036), but genotype was not a significant predictor of salt taste sensitivity. ","[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Gia', 'Initials': 'G', 'LastName': 'Mudd-Martin', 'Affiliation': ''}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Estus', 'Affiliation': ''}, {'ForeName': 'Terry A', 'Initials': 'TA', 'LastName': 'Lennie', 'Affiliation': ''}, {'ForeName': 'Misook L', 'Initials': 'ML', 'LastName': 'Chung', 'Affiliation': ''}]",The Journal of cardiovascular nursing,['10.1097/JCN.0000000000000692'] 664,32453835,A brief sleep focused psychoeducation program for sleep-related outcomes in new mothers: a randomized controlled trial.,"STUDY OBJECTIVES Poor sleep is commonly problematic during pregnancy and postpartum and is associated with depression. This trial investigated the efficacy of prenatal brief, group sleep psychoeducation in improving postpartum maternal sleep, and depression. METHODS A total of 215 healthy expectant first-time mothers were cluster randomized (1:1) to receive either a 2 × 1.5 h psychoeducation intervention and a set of booklets, or a set of booklets only. Participants completed questionnaires during pregnancy (pre-intervention), and 6 weeks and 4 months postpartum. A post hoc subset of questionnaires was collected at 10 months postpartum. The primary hypothesis was the intervention group would have improved postpartum sleep quality, and reduced levels of insomnia symptoms, fatigue, and daytime sleepiness compared to the control group. Secondary outcomes included depression, anxiety, and stress. RESULTS Linear mixed model analyses failed to confirm a group by time interaction on primary or secondary outcomes across all time points. There was no effect of the intervention on outcomes at 6 weeks, or 10 months postpartum. A significant time by group interaction was found at 4 months, favoring the intervention for sleep quality (p = 0.03) and insomnia symptoms (p = 0.03), but not fatigue or daytime sleepiness. CONCLUSIONS Prenatal sleep psychoeducation did not produce a sustained effect on maternal sleep throughout the postpartum period. There was little evidence of benefits on depressive symptoms. CLINICAL TRIAL REGISTRATION ACTRN12611000859987.",2020,"A significant time by group interaction was found at four months, favouring the intervention for sleep quality (p = 0.03) and insomnia symptoms (p = 0.03), but not fatigue or daytime sleepiness. ","['new mothers', '215 healthy expectant first-time mothers']","['prenatal brief, group sleep psychoeducation', 'Prenatal sleep psychoeducation', '2 x 1.5hr psychoeducation intervention', 'psychoeducation program']","['postpartum maternal sleep and depression', 'fatigue or daytime sleepiness', 'maternal sleep', 'depression, anxiety and stress', 'insomnia symptoms', 'postpartum sleep quality', 'sleep quality', 'depressive symptoms', 'levels of insomnia symptoms, fatigue and daytime sleepiness']","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",215.0,0.0839392,"A significant time by group interaction was found at four months, favouring the intervention for sleep quality (p = 0.03) and insomnia symptoms (p = 0.03), but not fatigue or daytime sleepiness. ","[{'ForeName': 'Liora', 'Initials': 'L', 'LastName': 'Kempler', 'Affiliation': 'School of Psychology, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Louise A', 'Initials': 'LA', 'LastName': 'Sharpe', 'Affiliation': 'School of Psychology, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Nathaniel S', 'Initials': 'NS', 'LastName': 'Marshall', 'Affiliation': 'Sleep and Circadian Research Group (CIRUS) and NeuroSleep Centre of Research Excellence, Woolcock Institute of Medical Research, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Delwyn J', 'Initials': 'DJ', 'LastName': 'Bartlett', 'Affiliation': 'Sleep and Circadian Research Group (CIRUS) and NeuroSleep Centre of Research Excellence, Woolcock Institute of Medical Research, University of Sydney, Sydney, Australia.'}]",Sleep,['10.1093/sleep/zsaa101'] 665,32524888,Elective replacement of peripheral intravenous cannulas in neonates.,"BACKGROUND Newborns admitted to neonatal units often require vascular access. Peripheral intravenous cannulas allow essential medication, fluids, and/or parenteral nutrition to be delivered. Peripheral intravenous cannulas are often associated with complications, such as extravasation, infiltration, phlebitis, leakage, spontaneous dislodgement, and catheter-associated blood stream infection. METHODS A secondary analysis of a randomized controlled trial evaluating standard replacement versus elective replacement (72-96 h) of peripheral intravenous cannula was conducted in a tertiary-level neonatal unit in Melbourne, Australia. The main outcome of this analysis was to assess the risk of combined adverse events associated with elective replacement of peripheral intravenous cannula. A cost analysis of the intervention was also conducted. RESULTS Combined adverse outcomes noted per infant were 48 (87.27%) in the standard replacement group versus 44 (75.86%) in the elective replacement group (RR 0.87; 95% CI 0.71-1.04, p = 0.15). In terms of combined adverse outcome per 1000 intravenous hours, there was a significant risk ratio of 0.81 in the elective group compared with the standard group (95% CI 0.65-0.98, p = 0.04). Gestation (adjusted odds ratio (AOR) 0.58; 95% CI 0.35-0.96, p = 0.03), male gender (AOR 4.65; 95% CI 1.07-20.28, p = 0.04), elective replacement (AOR 0.12; 95% CI 0.03-0.68, p = 0.01), and the total number of re-sites (AOR 27.84; 95% CI 4.61-168.18, p < 0.001) were significant risk factors associated with adverse events. There were also significantly higher costs involved with elective replacement. CONCLUSION Elective replacement of peripheral intravenous cannulas was not shown to reduce the risk of combined adverse events. Elective peripheral intravenous cannula replacement also incurred a higher cost.",2021,"Gestation (adjusted odds ratio (AOR) 0.58; 95% CI 0.35-0.96, p = 0.03), male gender (AOR 4.65; 95% CI 1.07-20.28, p = 0.04), elective replacement (AOR 0.12; 95% CI 0.03-0.68, p = 0.01), and the total number of re-sites (AOR 27.84; 95% CI 4.61-168.18, p < 0.001) were significant risk factors associated with adverse events.","['neonates', 'Newborns admitted to neonatal units often require vascular access', '72-96 h) of peripheral intravenous cannula was conducted in a tertiary-level neonatal unit in Melbourne, Australia']","['Elective replacement of peripheral intravenous cannulas', 'Elective peripheral intravenous cannula replacement', 'standard replacement versus elective replacement']","['total number of re-sites', 'elective replacement', 'risk of combined adverse events', 'risk of combined adverse events associated with elective replacement of peripheral intravenous cannula', 'risk ratio']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",,0.27204,"Gestation (adjusted odds ratio (AOR) 0.58; 95% CI 0.35-0.96, p = 0.03), male gender (AOR 4.65; 95% CI 1.07-20.28, p = 0.04), elective replacement (AOR 0.12; 95% CI 0.03-0.68, p = 0.01), and the total number of re-sites (AOR 27.84; 95% CI 4.61-168.18, p < 0.001) were significant risk factors associated with adverse events.","[{'ForeName': 'Darien Daojuin', 'Initials': 'DD', 'LastName': 'Liew', 'Affiliation': 'Department of Paediatrics, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': ""Monash Newborn, Monash Children's Hospital, Melbourne, VIC, Australia.""}, {'ForeName': 'Li Yen', 'Initials': 'LY', 'LastName': 'Chin', 'Affiliation': ""Monash Newborn, Monash Children's Hospital, Melbourne, VIC, Australia.""}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Davies-Tuck', 'Affiliation': 'The Ritchie Centre, Hudson Institute of Medical Research, Melbourne, VIC, Australia.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Malhotra', 'Affiliation': 'Department of Paediatrics, Monash University, Melbourne, VIC, Australia.'}]",The journal of vascular access,['10.1177/1129729820927235'] 666,32326749,Acceptability and feasibility of a Japanese version of STrAtegies for RelaTives (START-J): A manualized coping strategy program for family caregivers of relatives living with dementia.,"The rising older population in Japan is associated with a rise in cases of dementia. Support for the increased number of family caregivers of people living with dementia is crucial, as caring may negatively affect a family caregiver's health. This study seeks to evaluate the feasibility and applicability of a recently developed Japanese version of START (STrAtegies for RelaTives). START is a psychosocial coping intervention program developed in the United Kingdom that has been shown to improve caregivers' mood and quality of life in a randomized controlled trial. We made changes to START (e.g., idioms, linguistic nuance, and providing care insurance information suited for Japan) to make it culturally appropriate. Fourteen Japanese female family caregivers of relatives with mild dementia (n = 10) or mild cognitive impairment (n = 4) were referred to the study, but six were excluded owing to illness and busyness. This single-arm study had a before-after trial evaluating psychological outcomes including depression, anxiety, quality of life, and subjective care burden. The acceptance retention and satisfaction rate suggest the feasibility and acceptability of the START program; 8/14 (>55%) eligible, prospective participants consented and were included in this study, all (8/8) of whom completed all START sessions. The mean program satisfaction score was 30.25 (standard deviation = 2.25) out of a potential 32. The results suggest that it is feasible and acceptable to deliver START in Japanese and based on the results of analysis using a linear mixed model, there is initial indication that the intervention improved family caregivers' quality of life, depressive symptoms, and care burden.",2021,"The acceptance retention and satisfaction rate suggest the feasibility and acceptability of the START program; 8/14 (>55%) eligible, prospective participants consented and were included in this study, all (8/8) of whom completed all START sessions.","['family caregivers of relatives living with dementia', 'RelaTives (START-J', 'Fourteen Japanese female family caregivers of relatives with mild dementia (n\u2009=\u200910) or mild cognitive impairment (n\u2009=\u20094) were referred to the study, but six were excluded owing to illness and busyness', 'RelaTives']","['manualized coping strategy program', 'Japanese version']","[""family caregivers' quality of life, depressive symptoms, and care burden"", 'mean program satisfaction score', 'depression, anxiety, quality of life, and subjective care burden', 'acceptance retention and satisfaction rate']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0557089', 'cui_str': 'Relatives surviving - finding'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3494623', 'cui_str': 'Mild dementia'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]","[{'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}]","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",14.0,0.0494264,"The acceptance retention and satisfaction rate suggest the feasibility and acceptability of the START program; 8/14 (>55%) eligible, prospective participants consented and were included in this study, all (8/8) of whom completed all START sessions.","[{'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Kashimura', 'Affiliation': 'Department of Medical Psychology, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Rapaport', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Nomura', 'Affiliation': 'Department of Medical Psychology, Nippon Medical School, Tokyo, Japan; Dementia Centre, Nippon Medical School Musashi Kosugi Hospital, Kawasaki, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Ishiwata', 'Affiliation': 'Department of Neurology, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Amane', 'Initials': 'A', 'LastName': 'Tateno', 'Affiliation': 'Department of Psychiatry, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Akane', 'Initials': 'A', 'LastName': 'Nogami', 'Affiliation': 'Department of Neurology, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Yamashita', 'Affiliation': 'Research Team for Social Participation and Community Health, Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan.'}, {'ForeName': 'Tomoya', 'Initials': 'T', 'LastName': 'Kawanishi', 'Affiliation': 'Department of Clinical Psychology, Graduate School of Education, Naruto University of Education, Tokushima, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Kawashima', 'Affiliation': 'Department of Psycho-Social Studies, School of Arts and Letters, Meiji University, Tokyo, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Kitamura', 'Affiliation': 'Dementia Centre, Nippon Medical SchoolMusashi Kosugi Hospital, Kawasaki, Japan.'}, {'ForeName': 'Gill', 'Initials': 'G', 'LastName': 'Livingston', 'Affiliation': 'Division of Psychiatry, University College London, London, UK; Camden and Islington NHS Foundation Trust, London, UK.'}]","Dementia (London, England)",['10.1177/1471301220919938'] 667,32529940,Effectiveness of transparent film dressing for peripheral intravenous catheter.,"BACKGROUND The intravenous applications are the most common type of such interventions. It is underlined that in cases where the peripheral intravenous catheter is not properly secured in place, even a minor movement inside the vein would result in injury of vein. OBJECTIVE The insertion of peripheral intravenous catheter is a common practice. This is a randomized controlled prospective study aiming at investigating the effectiveness of use of transparent film dressing for peripheral intravenous catheter. METHODS The universe of this study included inpatients in the Internal Diseases clinic of a University Hospital, and the sample included a total of 110 peripheral intravenous catheters that were calculated by power analysis. The patient identification form, the peripheral venous catheter and treatment information form, and the visual infusion phlebitis identification scale were used to collect data. The forms were completed by the investigators on the basis of daily observations. The data were assessed by the percentage, chi-square test, and logistic regression analysis via the software SPSS 20.00. RESULTS The individuals in the study group and the control group included in the sample are comparable in terms of gender, having/not having a chronic disease, the site of peripheral intravenous catheter, use of antibiotics, intravenous fluid therapy, and mean age. There were no statistically significant differences between the groups. There was a significant relationship between the dwell time for the catheter and development of any complications and the groups. CONCLUSION The use of transparent film dressing for insertion of peripheral intravenous catheter can be recommended as it increases the dwell time for the catheter and reduces incidence of complications.",2021,"There was a significant relationship between the dwell time for the catheter and development of any complications and the groups. ","['individuals in the study group and the control group included in the sample are comparable in terms of gender, having/not having a chronic disease, the site of peripheral intravenous catheter, use of antibiotics, intravenous fluid therapy, and mean age', 'peripheral intravenous catheter', 'inpatients in the Internal Diseases clinic of a University Hospital, and the sample included a total of 110 peripheral intravenous catheters that were calculated by power analysis']",['transparent film dressing'],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0179768', 'cui_str': 'Peripheral intravenous catheter'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0770788', 'cui_str': 'Transparent dressing'}]",[],110.0,0.0473162,"There was a significant relationship between the dwell time for the catheter and development of any complications and the groups. ","[{'ForeName': 'Selma', 'Initials': 'S', 'LastName': 'Atay', 'Affiliation': 'Nursing Department at Faculty of Health Science, Çanakkale Onsekiz Mart University, Canakkale, Turkey.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Yilmaz Kurt', 'Affiliation': 'Nursing Department at Faculty of Health Science, Çanakkale Onsekiz Mart University, Canakkale, Turkey.'}]",The journal of vascular access,['10.1177/1129729820927238'] 668,32531798,"Long-term safety of certolizumab pegol in plaque psoriasis: pooled analysis over 3 years from three phase III, randomized, placebo-controlled studies.","BACKGROUND Certolizumab pegol (CZP) is an Fc-free, PEGylated anti-tumour necrosis factor biologic. OBJECTIVES To report 3-year safety data from three phase III trials of CZP in adults with plaque psoriasis. METHODS Data were pooled from CIMPASI-1 (NCT02326298), CIMPASI-2 (NCT02326272) and CIMPACT (NCT02346240). Included patients had moderate-to-severe plaque psoriasis of ≥ 6 months' duration; had been randomized to CZP 200 mg every 2 weeks (Q2W) (400 mg at weeks 0, 2 and 4) or CZP 400 mg Q2W; and had received at least one dose of CZP with up to 144 weeks of exposure. Treatment-emergent adverse events (TEAEs) were classified using MedDRA v18·1. Reported incidence rates (IRs) are incidence of new cases per 100 patient-years (PY). RESULTS Over 144 weeks, 995 patients received at least one dose of CZP (exposure: 2231·3 PY); 731 and 728 received at least one dose of CZP 200 mg Q2W (1211·4 PY) and/or 400 mg Q2W (1019·9 PY), respectively. The IR [95% confidence interval (CI)] of TEAEs was 144·9 (135·3-155·0) for all patients, 134·1 (123·2-145·7) for CZP 200 mg Q2W and 158·3 (145·5-171·9) for CZP 400 mg Q2W. The IR (95% CI) of serious TEAEs for all patients was 7·5 (6·4-8·8); the IRs were 6·7 (5·2-8·3) and 8·7 (6·9-10·8) for CZP 200 mg and 400 mg Q2W, respectively. Overall, 3·2% of patients reported serious infections (2·2% within each of the CZP 200 and 400 mg Q2W groups). Overall, there was one case of active tuberculosis, 16 malignancies in 14 patients and seven deaths (two considered treatment-related). The cumulative IR of TEAEs did not increase over time. CONCLUSIONS No new safety signals were identified compared with previously reported data. Risk did not increase with longer or higher CZP exposure.",2021,3.2% patients reported serious infections (2.2% within each of the CZP 200 and 400 mg Q2W groups).,"['Plaque Psoriasis', 'Included patients: had moderate to severe PSO ≥6 months', 'adults with plaque psoriasis (PSO', '995 patients received ≥1 dose CZP (exposure: 2,231.3 PY); 731 and 728 received']","['Placebo', 'CZP 400 mg Q2W', 'Certolizumab Pegol', 'CZP', 'Certolizumab pegol (CZP', '≥1 dose CZP 200 mg Q2W']","['serious infections', 'Cumulative IR of TEAEs']","[{'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1872109', 'cui_str': 'certolizumab pegol'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1872109', 'cui_str': 'certolizumab pegol'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4026841', 'cui_str': 'certolizumab pegol 200 MG'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",995.0,0.282486,3.2% patients reported serious infections (2.2% within each of the CZP 200 and 400 mg Q2W groups).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, OR, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Paul', 'Affiliation': 'Paul Sabatier University, Toulouse, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'van de Kerkhof', 'Affiliation': 'Radboud University, Nijmegen, the Netherlands.'}, {'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Warren', 'Affiliation': 'Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, The University of Manchester, Manchester, UK.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Gottlieb', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'Langley', 'Affiliation': 'Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Brock', 'Affiliation': 'UCB Pharma, Slough, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Arendt', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Boehnlein', 'Affiliation': 'UCB Pharma, Monheim, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lebwohl', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",The British journal of dermatology,['10.1111/bjd.19314'] 669,32552707,Correlation of binocular refractive error and calculation of intraocular Lens power for the second eye.,"BACKGROUND Reducing refractive error has always been a tricky problem. The aim of this study was to verify the correlation between binocular refractive error (RE) after sequential cataract surgery and explore an individualized calculation method of intraocular lens (IOL) for the second eye. METHODS This was a prospective study. One hundred eighty-eight affected eyes in 94 age-related cataract patients who underwent sequential cataract surgery in the Department of Ophthalmology, Tangdu Hospital, China, were recruited. Complete case data were included for a correlation analysis of binocular RE. Data obtained in patients with RE values greater than 0.50 diopters (D) in the first eye were extracted and the patients divided randomly into two groups: Group A and B. In the adjustment group, group A, we modified the IOL power for the second eyes as 50% of the RE of the first eye. In group B, the control group, there was no modification. The mean absolute refractive error (MARE) values of the second eyes were evaluated one month after surgery. RESULTS The correlation coefficient of the binocular RE after sequential cataract surgery was 0.760 (P < 0.001). After the IOL power of the second eyes was adjusted, the MARE of the second eyes was 0.57 ± 0.41 D, while the MARE of the first eyes was 1.18 ± 0.85 D, and the difference was statistically significant (P < 0.001). CONCLUSIONS Binocular REs were positively correlated after sequential cataract surgery. The RE of the second eye can be reduced by adjusting the IOL power based on 50% of the postoperative RE of the first eye.",2020,The correlation coefficient of the binocular RE after sequential cataract surgery was 0.760 (P < 0.001).,"['One hundred eighty-eight affected eyes in 94 age-related cataract patients who underwent sequential cataract surgery in the Department of Ophthalmology, Tangdu Hospital, China, were recruited', 'patients with RE values greater than 0.50 diopters (D) in the first eye']",['sequential cataract surgery and explore an individualized calculation method of intraocular lens (IOL'],"['binocular refractive error (RE', 'IOL power', 'mean absolute refractive error (MARE) values', 'binocular RE']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0034951', 'cui_str': 'Disorder of refraction'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439484', 'cui_str': 'Diopters'}]","[{'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C1441506', 'cui_str': 'Calculation technique'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}]","[{'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0034951', 'cui_str': 'Disorder of refraction'}, {'cui': 'C0429521', 'cui_str': 'Intraocular lens power'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",188.0,0.0263921,The correlation coefficient of the binocular RE after sequential cataract surgery was 0.760 (P < 0.001).,"[{'ForeName': 'Pengcheng', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': ""Xi'an Fourth Hospital, Shaanxi Eye Hospital, Affiliated Xi'an Fourth Hospital, Northwestern Polytechnical University, Xi'an, 710004, Shaanxi Province, China.""}, {'ForeName': 'Yuhuan', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Ophthalmology, Tangdu Hospital, Fourth Military Medical University, Xi'an, 710038, Shaanxi Province, China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': ""Xi'an Fourth Hospital, Shaanxi Eye Hospital, Affiliated Xi'an Fourth Hospital, Northwestern Polytechnical University, Xi'an, 710004, Shaanxi Province, China. yan2128ts@hotmail.com.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Ophthalmology, Tangdu Hospital, Fourth Military Medical University, Xi'an, 710038, Shaanxi Province, China.""}, {'ForeName': 'Weijia', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': 'Department of Ophthalmology, University of Heidelberg, 69120, Heidelberg, Germany.'}]",BMC ophthalmology,['10.1186/s12886-020-01496-9'] 670,32554693,What predicts poor outcome after successful thrombectomy in late time windows?,"BACKGROUND Thrombectomy for acute ischemic stroke treatment leads to improved outcomes, but many patients do not achieve a good outcome despite successful reperfusion. We determined predictors of poor outcome after successful thrombectomy (TICI 2b-3) with an emphasis on modifiable factors. METHODS Patients from the randomized DEFUSE 3 trial who underwent thrombectomy with TICI 2b-3 revascularization were included. Primary outcome was a poor outcome at 90 days (modified Rankin Scale score 3-6). RESULTS 70 patients were included. Poor outcome patients were older (73.5 vs 66.5 years; P=0.01), more likely to be female (68% vs 39%; P=0.02), had higher NIHSS scores (20 vs 13; P<0.001), and had poor cerebral perfusion collaterals (hypoperfusion intensity ratio) (median 0.45 vs 0.38; P=0.03). Following thrombectomy, poor outcome patients had larger 24 hour' core infarctions (median 59.5 vs 29.9 mL; P=0.01), more core infarction growth (median 33.6 vs 13.4 mL; P<0.001), and more mild (65% vs 50%; P=0.02) and severe (18% vs 0%; P=0.01) reperfusion hemorrhage. In a logistic regression analysis, the presence of any reperfusion hemorrhage (OR 3.3 [95% CI, 1.67 to 5]; P=0.001), age (OR 1.1 [95% CI, 1.03 to 1.11], P=0.004), higher NIHSS (OR 1.25 [95% CI, 1.07 to 1.41], P=0.002), and time from imaging to femoral artery puncture (OR 5 [95% CI, 1.16 to 16.67], P=0.03) independently predicted poor outcomes. CONCLUSIONS In late time windows, both mild and severe reperfusion hemorrhage were associated with poor outcomes. Older age, higher NIHSS, and increased time from imaging to arterial puncture were also associated with poor outcomes despite successful revascularization. TRIAL REGISTRATION https://clinicaltrials.gov/ct2/show/NCT02586415.",2021,"Poor outcome patients were older (73.5 vs 66.5 years; P=0.01), more likely to be female (68% vs 39%; P=0.02), had higher NIHSS scores (20 vs 13; P<0.001), and had poor cerebral perfusion collaterals (hypoperfusion intensity ratio) (median 0.45 vs 0.38; P=0.03).","['Patients from the randomized DEFUSE 3 trial who underwent thrombectomy with TICI 2b-3 revascularization were included', '70 patients were included']",[],"['poor cerebral perfusion collaterals (hypoperfusion intensity ratio', ""larger 24\u2009hour' core infarctions"", 'poor outcome at 90\u2009days (modified Rankin Scale score 3-6', 'mild and severe reperfusion hemorrhage', 'time from imaging to femoral artery puncture', 'higher NIHSS', 'reperfusion hemorrhage', 'core infarction growth', 'NIHSS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C1275670', 'cui_str': 'Collateral branch of vessel'}, {'cui': 'C0442856', 'cui_str': 'Hypoperfusion'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}]",70.0,0.21079,"Poor outcome patients were older (73.5 vs 66.5 years; P=0.01), more likely to be female (68% vs 39%; P=0.02), had higher NIHSS scores (20 vs 13; P<0.001), and had poor cerebral perfusion collaterals (hypoperfusion intensity ratio) (median 0.45 vs 0.38; P=0.03).","[{'ForeName': 'Jeremy J', 'Initials': 'JJ', 'LastName': 'Heit', 'Affiliation': 'Department of Radiology, Stanford University, Stanford, California, USA jheit@stanford.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mlynash', 'Affiliation': 'Department of Neurology, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Soren', 'Initials': 'S', 'LastName': 'Christensen', 'Affiliation': 'Department of Neurology, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Kemp', 'Affiliation': 'Department of Neurology, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Maarten G', 'Initials': 'MG', 'LastName': 'Lansberg', 'Affiliation': 'Department of Neurology, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Marks', 'Affiliation': 'Department of Radiology, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Olivot', 'Affiliation': 'Vascular Neurology, Stroke Department, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'Albers W', 'Initials': 'AW', 'LastName': 'Gregory', 'Affiliation': 'Department of Neurology, Stanford University, Stanford, California, USA.'}]",Journal of neurointerventional surgery,['10.1136/neurintsurg-2020-016125'] 671,32683460,Kirschner wire versus Herbert screw fixation for the treatment of unstable scaphoid waist fracture nonunion using corticocancellous iliac bone graft: randomized clinical trial.,"PURPOSE The study compared the impact of the Kirschner wires versus Herbert screw fixation on the rate of union, time to union, correction of deformity, and clinical outcome in adults with unstable scaphoid waist fracture nonunions without avascular necrosis. METHODS We prospectively randomized 122 patients to undergo corticocancellous iliac bone grafting and internal fixation either with multiple Kirschner wires or Herbert screw. Radiographs, clinical outcome measures (pain, range of motion, and grip strength), and the Quick DASH score were taken pre- and post-operatively. RESULTS The rate of the scaphoid union in the Kirschner wire group was 91% versus 88% in the Herbert group. No difference was detected between the two groups with respect to the time to union, deformity correction, pain analysis, range of motion, grip strength, return to work, and complications. CONCLUSION Using of multiple Kirschner wires as a fixation method for unstable scaphoid waist fracture nonunion that was treated by open reduction and corticocancellous iliac bone grafting had a shorter operative time and lower cost as compared with the Herbert screw fixation. Herbert screw fixation was technically more demanding in terms of technique than K-wires. However, because of easy application of Kirschner wires, and low cost, especially in developing countries, it may be a good alternative to Herbert screw.",2020,"No difference was detected between the two groups with respect to the time to union, deformity correction, pain analysis, range of motion, grip strength, return to work, and complications. ","['unstable scaphoid waist fracture nonunion using corticocancellous iliac bone graft', 'adults with unstable scaphoid waist fracture nonunions without avascular necrosis', '122 patients to undergo']","['multiple Kirschner wires', 'Herbert screw fixation', 'corticocancellous iliac bone grafting and internal fixation either with multiple Kirschner wires or Herbert screw', 'Kirschner wires versus Herbert screw fixation', 'Kirschner wire versus Herbert screw fixation']","['Radiographs, clinical outcome measures (pain, range of motion, and grip strength), and the Quick DASH score', 'rate of the scaphoid union', 'rate of union, time to union, correction of deformity, and clinical outcome', 'time to union, deformity correction, pain analysis, range of motion, grip strength, return to work, and complications']","[{'cui': 'C0443343', 'cui_str': 'Unstable status'}, {'cui': 'C0448063', 'cui_str': 'Entire waist of scaphoid bone'}, {'cui': 'C0016665', 'cui_str': 'Fracture, ununited'}, {'cui': 'C0020889', 'cui_str': 'Bone structure of ilium'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027543', 'cui_str': 'Avascular necrosis of bone'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0086510', 'cui_str': 'K-wire'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0020889', 'cui_str': 'Bone structure of ilium'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}]","[{'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0223724', 'cui_str': 'Bone structure of scaphoid'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",122.0,0.0353334,"No difference was detected between the two groups with respect to the time to union, deformity correction, pain analysis, range of motion, grip strength, return to work, and complications. ","[{'ForeName': 'Galal', 'Initials': 'G', 'LastName': 'Hegazy', 'Affiliation': 'Orthopedic Department, Faculty of Medicine, AL-Azhar University, Nasr City, Cairo, 11884, Egypt. glalhegazy@azhar.edu.eg.'}, {'ForeName': 'Ehab', 'Initials': 'E', 'LastName': 'Alshal', 'Affiliation': 'Orthopedic Department, Faculty of Medicine, AL-Azhar University, Assiut, 71524, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdelaal', 'Affiliation': 'Orthopedic Department, Faculty of Medicine, AL-Azhar University, Nasr City, Cairo, 11884, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdelaziz', 'Affiliation': 'Orthopedic Department, Faculty of Medicine, AL-Azhar University, Nasr City, Cairo, 11884, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Moawad', 'Affiliation': 'Orthopedic Department, Faculty of Medicine, AL-Azhar University, Nasr City, Cairo, 11884, Egypt.'}, {'ForeName': 'Yasser M', 'Initials': 'YM', 'LastName': 'Saqr', 'Affiliation': 'Orthopedic Department, Faculty of Medicine, Port Said University, Port Said, 11884, Egypt.'}, {'ForeName': 'Ibrahem', 'Initials': 'I', 'LastName': 'El-Sebaey', 'Affiliation': 'Orthopedic Department, Faculty of Medicine, AL-Azhar University, Nasr City, Cairo, 11884, Egypt.'}, {'ForeName': 'Mokhtar', 'Initials': 'M', 'LastName': 'Abdelazeem', 'Affiliation': 'Orthopedic Department, Faculty of Medicine, AL-Azhar University, Nasr City, Cairo, 11884, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'El-Barody', 'Affiliation': 'Radiodiagnosis Department, South Egypt Cancer Institute, Assiut University, Assiut, 71524, Egypt.'}]",International orthopaedics,['10.1007/s00264-020-04730-7'] 672,32567654,"Impact of Succinct Training on Open Cricothyrotomy Performance: A Randomized, Prospective, Observational Study of U.S. Army First Responders.","INTRODUCTION Primary airway failure has become the second most common cause of potentially survivable battlefield fatality. Cricothyrotomy is taught to all U.S. military providers as a means of securing an airway in extremis. However, retrospective studies show that cricothyrotomy failure rates for U.S. military first responders performing the procedure in combat is 33%. Our hypothesis was that these rates could be improved. MATERIALS AND METHODS We conducted a randomized, prospective, observational study to evaluate the effects of inexpensive, succinct training on open cricothyrotomy performance by studying two unique U.S. Army First Responder participant groups. One participant group consisted of regular U.S. Army Medics (68 Ws). The second group was Special Operations Combat Medics. We evaluated both groups' baseline ability to correctly perform a cricothyrotomy and then randomly assigned individuals within each group to either a training or practice group. RESULTS The training group had a higher proportion of success and performed the cricothyrotomy faster than the practice group with 68 Ws group appearing to benefit most from training: their procedural success rates increased by an average of 23%, and their average time-to-correct-placement decreased by 21 seconds-a 33% improvement over baseline. CONCLUSION With one manikin, a qualified trainer, and $35 worth of expendable supplies, 10 medics could be trained in the procedure in just 2-3 hours. Our study suggests that this simple intervention has the potential to significantly improve U.S. Army First Responders' ability to correctly perform an open cricothyrotomy and drastically decrease the time needed to perform this lifesaving procedure correctly, possibly saving one in four potentially survivable combat casualties suffering from airway compromise.",2020,"The training group had a higher proportion of success and performed the cricothyrotomy faster than the practice group with 68 Ws group appearing to benefit most from training: their procedural success rates increased by an average of 23%, and their average time-to-correct-placement decreased by 21 seconds-a 33% improvement over baseline. ",[],"['training or practice group', 'regular U.S. Army Medics', 'Cricothyrotomy', 'Succinct Training', 'inexpensive, succinct training']","['procedural success rates', 'Open Cricothyrotomy Performance', 'average time-to-correct-placement']",[],"[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0030450', 'cui_str': 'Paramedical Personnel'}, {'cui': 'C0396429', 'cui_str': 'Cricothyroidotomy'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0396429', 'cui_str': 'Cricothyroidotomy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",,0.0179072,"The training group had a higher proportion of success and performed the cricothyrotomy faster than the practice group with 68 Ws group appearing to benefit most from training: their procedural success rates increased by an average of 23%, and their average time-to-correct-placement decreased by 21 seconds-a 33% improvement over baseline. ","[{'ForeName': 'Kurtis L', 'Initials': 'KL', 'LastName': 'Muller', 'Affiliation': 'Special Warfare Medical Group (Airborne) 1975 Combat Medic Rd, Fort Bragg NC 28310.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Facciolla', 'Affiliation': '1st Special Forces Command (Airborne) 1625 Reilly Rd, Fort Bragg, NC 28310.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Monti', 'Affiliation': 'Madigan Army Medical Center 9040A Jackson Ave, Joint Base Lewis-McChord, WA 98431.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Cronin', 'Affiliation': 'Madigan Army Medical Center 9040A Jackson Ave, Joint Base Lewis-McChord, WA 98431.'}]",Military medicine,['10.1093/milmed/usaa035'] 673,32563960,Cost-effectiveness of preoperative magnetic resonance imaging to optimize surgery in ductal carcinoma in situ of the breast.,"PURPOSE Complete surgical excision is the main factor for successful breast-conserving surgery in patients with ductal carcinoma in situ (DCIS) of the breast. Preoperative magnetic resonance imaging (MRI) may allow surgery optimization in this indication. From an economic standpoint, systematic preoperative MRI is associated with an extra cost, which may be offset by a decrease in the number of re-interventions. We performed an economic evaluation alongside IRCIS randomised controlled trial (NCT01112254) to determine whether systematic preoperative MRI in DCIS is a cost-effective strategy. METHODS 360 patients were included in IRCIS trial. Costs were assessed from the French national health insurance perspective. Resource use was prospectively collected during a 6-month period after randomisation. We estimated the mean cost per averted re-intervention. RESULTS Despite extra costs due to MRI and additional biopsies, difference in total costs between arms was not statistically significant (mean cost of €9980 in MRI arm and €9682 in no MRI arm, cost difference: €298 [CI95% : -470; 1063]). There was a non-significant decrease in the rate of re-hospitalisations for positive or close margins (20% in MRI arm versus 27% in No MRI arm, difference -7% [CI95% : -17; 3]). At a willingness to pay of €500 to avert a re-intervention, the probability that MRI strategy is cost-effective was 93%. CONCLUSION Systematic preoperative MRI in patients with DCIS of the breast may be a cost-effective strategy. However, the modest clinical benefit associated with such a strategy limits the interest for this procedure in routine practice given the current MRI techniques.",2020,"Despite extra costs due to MRI and additional biopsies, difference in total costs between arms was not statistically significant (mean cost of €9980 in MRI arm and €9682 in no MRI arm, cost difference:","['360 patients were included in IRCIS trial', '€298', 'ductal carcinoma in situ of the breast', 'patients with ductal carcinoma in situ (DCIS) of the breast']","['Preoperative magnetic resonance imaging (MRI', 'preoperative magnetic resonance imaging']","['total costs', 'mean cost per averted re-intervention', 'rate of re-hospitalisations']","[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007124', 'cui_str': 'Intraductal carcinoma, noninfiltrating'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",360.0,0.132549,"Despite extra costs due to MRI and additional biopsies, difference in total costs between arms was not statistically significant (mean cost of €9980 in MRI arm and €9682 in no MRI arm, cost difference:","[{'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Kandel', 'Affiliation': ""Gustave Roussy, Service de Biostatistique et d'Epidémiologie, Villejuif, F-94805, France; CESP, Fac. de médecine, Univ. Paris-Sud, Fac. de médecine, UVSQ, INSERM, Université Paris-Saclay, Villejuif, 94805, France.""}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Dunant', 'Affiliation': ""Gustave Roussy, Service de Biostatistique et d'Epidémiologie, Villejuif, F-94805, France.""}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Balleyguier', 'Affiliation': 'Gustave Roussy, Department of Medical Imaging, 114 rue Edouard Vaillant, Villejuif, F-94805, France. Electronic address: corinne.balleyguier@gustaveroussy.fr.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Bonastre', 'Affiliation': ""Gustave Roussy, Service de Biostatistique et d'Epidémiologie, Villejuif, F-94805, France; CESP, Fac. de médecine, Univ. Paris-Sud, Fac. de médecine, UVSQ, INSERM, Université Paris-Saclay, Villejuif, 94805, France.""}]",European journal of radiology,['10.1016/j.ejrad.2020.109058'] 674,31885339,Transurethral holmium laser resection and transurethral electrocision combined with intravesical epirubicin within 24 hours postoperatively for treatment of bladder cancer.,"OBJECTIVE To investigate the efficacy and safety of transurethral holmium laser resection (THOLR) and transurethral electrocision (TUR) combined with intravesical epirubicin within 24 hours postoperatively for treatment of non-muscular invasive bladder cancer. METHODS A total of 218 consecutive patients who were newly diagnosed with bladder cancer were enrolled in this prospective study from July 2014 to December 2017. The patients were randomly divided into THOLR and TUR groups. All patients received intravesical epirubicin (30 mg dissolved in 5% glucose solution) within 24 hours postoperatively. The operation time, blood loss, rate of obturator reflex, hospitalization time, catheterization time, complications, and recurrence were analyzed. RESULTS Operation, hospitalization, and catheterization times were significantly greater in the TUR group than in the THOLR group. The rates of blood loss and intraoperative obturator reflex were also significantly greater in the TUR group. There were no significant differences in complications, recurrence rate survival, or recurrence-free survival between the two groups, with the exception of bladder perforation rate. CONCLUSIONS THOLR and TUR combined with intravesical epirubicin within 24 hours postoperatively were both safe and effective for treatment of bladder tumor; however, patients who undergo THOLR might experience more rapid recovery.",2020,"There were no significant differences in complications, recurrence rate survival, or recurrence-free survival between the two groups, with the exception of bladder perforation rate. ","['218 consecutive patients who were newly diagnosed with bladder cancer were enrolled in this prospective study from July 2014 to December 2017', 'non-muscular invasive bladder cancer', 'bladder cancer']","['transurethral holmium laser resection (THOLR) and transurethral electrocision (TUR) combined with intravesical epirubicin', 'TUR', 'THOLR and TUR combined with intravesical epirubicin', 'Transurethral holmium laser resection and transurethral electrocision combined with intravesical epirubicin', 'intravesical epirubicin']","['Operation, hospitalization, and catheterization times', 'efficacy and safety', 'operation time, blood loss, rate of obturator reflex, hospitalization time, catheterization time, complications, and recurrence', 'complications, recurrence rate survival, or recurrence-free survival', 'rates of blood loss and intraoperative obturator reflex']","[{'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}]","[{'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0442124', 'cui_str': 'Intravesical approach'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182021', 'cui_str': 'Obturator'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]",218.0,0.0160123,"There were no significant differences in complications, recurrence rate survival, or recurrence-free survival between the two groups, with the exception of bladder perforation rate. ","[{'ForeName': 'Jiawei', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Urology, The Affiliated Zhangjiagang Hospital of Soochow University, Zhangjiagang, jiangsu, China.'}, {'ForeName': 'Yagang', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': 'Department of Urology, The Affiliated Zhangjiagang Hospital of Soochow University, Zhangjiagang, jiangsu, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Shen', 'Affiliation': 'Department of Urology, The Affiliated Zhangjiagang Hospital of Soochow University, Zhangjiagang, jiangsu, China.'}, {'ForeName': 'Hongxing', 'Initials': 'H', 'LastName': 'Gu', 'Affiliation': 'Department of Urology, The Affiliated Zhangjiagang Hospital of Soochow University, Zhangjiagang, jiangsu, China.'}, {'ForeName': 'Haiyong', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, The Affiliated Zhangjiagang Hospital of Soochow University, Zhangjiagang, jiangsu, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': 'Department of Urology, The Affiliated Zhangjiagang Hospital of Soochow University, Zhangjiagang, jiangsu, China.'}, {'ForeName': 'Huidong', 'Initials': 'H', 'LastName': 'Miao', 'Affiliation': 'Department of Urology, The Affiliated Zhangjiagang Hospital of Soochow University, Zhangjiagang, jiangsu, China.'}]",The Journal of international medical research,['10.1177/0300060519887267'] 675,32573426,Rapid and sustained improvements in patient-reported signs and symptoms with ixekizumab in biologic-naive and TNF-inadequate responder patients with psoriatic arthritis.,"OBJECTIVES To analyse the onset and sustainability of patient-reported improvements in symptoms of psoriatic arthritis (PsA) following treatment with ixekizumab (IXE) up to Week 108. METHODS In patients with active PsA, either naive to biological DMARDs (SPIRIT-P1) or having inadequate response or intolerance to 1 or 2 prior TNF-inhibitors (TNFi‑experienced; SPIRIT-P2), we analysed the change from baseline in joint pain visual analogue scale (VAS; 0-100 scale), patient global assessment (PatGA VAS; 0-100 scale), fatigue numerical rating scale (NRS; 0 [no fatigue] to 10 [worst imaginable]), and Health Assessment Questionnaire-Disability Index (HAQ-DI; 0-3), up to Week 108. RESULTS IXE-treated patients compared to placebo reported rapid and statistically significant improvement in pain VAS, PatGA, and HAQ-DI as early as Week 1 and this benefit was sustained or increased through Week 108. Fatigue scores improved in IXE-treated patients compared to placebo in both studies; results were statistically significant at Week 24 only in SPIRIT-P2. Improvements in fatigue with IXE were sustained over 2 years. The improvements observed in these patient-reported outcomes (PROs) were consistent in biologic-naive or TNFi-experienced patients. CONCLUSIONS Patients treated with IXE versus PBO achieved significantly greater improvements and showed faster onset of improvements in patient-reported outcomes measuring symptoms and impact of PsA. Responses were sustained over 2 years and were generally consistent regardless of prior TNFi experience.",2021,Fatigue scores improved in IXE-treated patients compared to placebo in both studies; results were statistically significant at Week 24 only in SPIRIT-P2.,[],"['ixekizumab (IXE', 'IXE versus PBO', 'placebo']","['fatigue with IXE', 'Fatigue scores', 'joint pain visual analogue scale (VAS; 0-100 scale), patient global assessment (PatGA VAS; 0-100 scale), fatigue numerical rating scale (NRS; 0', 'pain VAS, PatGA, and HAQ-DI', 'Health Assessment Questionnaire-Disability Index']",[],"[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0511214,Fatigue scores improved in IXE-treated patients compared to placebo in both studies; results were statistically significant at Week 24 only in SPIRIT-P2.,"[{'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Orbai', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA. aorbai1@jhmi.edu.'}, {'ForeName': 'Dafna D', 'Initials': 'DD', 'LastName': 'Gladman', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Goto', 'Affiliation': 'Osaka City General Hospital, Osaka, Japan.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Birt', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Gellett', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Chen-Yen', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Tore K', 'Initials': 'TK', 'LastName': 'Kvien', 'Affiliation': 'Diakonhjemmet Hospital, Oslo, Norway.'}]",Clinical and experimental rheumatology,[] 676,32576287,"A randomized single-dose, two-period crossover bioequivalence study of two fixed-dose Paracetamol/Orphenadrine combination preparations in healthy volunteers under fasted condition.","BACKGROUND Paracetamol/Orphenadrine is a fixed dose combination containing 35 mg orphenadrine and 450 mg paracetamol. It has analgesic and muscle relaxant properties and is widely available as generics. This study is conducted to investigate the relative bioavailability and bioequivalence between one fixed dose paracetamol/orphenadrine combination test preparation and one fixed dose paracetamol/orphenadrine combination reference preparation in healthy volunteers under fasted condition for marketing authorization in Malaysia. METHOD This is a single-center, single-dose, open-label, randomized, 2-treatment, 2-sequence and 2-period crossover study with a washout period of 7 days. Paracetamol/Orphenadrine tablets were administered after a 10-h fast. Blood samples for pharmacokinetic analysis were collected at scheduled time intervals prior to and up to 72 h after dosing. Blood samples were centrifuged, and separated plasma were kept frozen (- 15 °C to - 25 °C) until analysis. Plasma concentrations of orphenadrine and paracetamol were quantified using liquid-chromatography-tandem mass spectrometer using diphenhydramine as internal standard. The pharmacokinetic parameters AUC 0-∞ , AUC 0-t and C max were determined using plasma concentration time profile for both preparations. Bioequivalence was assessed according to the ASEAN guideline acceptance criteria for bioequivalence which is the 90% confidence intervals of AUC 0-∞ , AUC 0-t and C max ratio must be within the range of 80.00-125.00%. RESULTS There were 28 healthy subjects enrolled, and 27 subjects completed this trial. There were no significant differences observed between the AUC 0-∞ , AUC 0-t and C max of both test and reference preparations in fasted condition. The 90% confidence intervals for the ratio of AUC 0-t (100.92-111.27%), AUC 0-∞ (96.94-108.08%) and C max (100.11-112.50%) for orphenadrine (n = 25); and AUC 0-t (94.29-101.83%), AUC 0-∞ (94.77-101.68%) and C max (87.12-101.20%) for paracetamol (n = 27) for test preparation over reference preparation were all within acceptable bioequivalence range of 80.00-125.00%. CONCLUSION The test preparation is bioequivalent to the reference preparation and can be used interchangeably. TRIAL REGISTRATION NMRR- 17-1266-36,001; registered and approved on 12 September 2017.",2020,"There were no significant differences observed between the AUC 0-∞ , AUC 0-t and C max of both test and reference preparations in fasted condition.","['healthy volunteers under fasted condition', 'healthy volunteers under fasted condition for marketing authorization in Malaysia', '28 healthy subjects enrolled, and 27 subjects completed this trial']","['diphenhydramine', 'Orphenadrine tablets', 'Paracetamol/Orphenadrine combination preparations', 'paracetamol/orphenadrine', 'Paracetamol', 'paracetamol', 'Paracetamol/Orphenadrine', 'paracetamol/orphenadrine combination reference preparation', 'orphenadrine and 450\u2009mg paracetamol']","['AUC 0-∞ , AUC 0-t and C max', 'relative bioavailability and bioequivalence', 'Plasma concentrations of orphenadrine and paracetamol', 'ratio of AUC 0-t', 'pharmacokinetic parameters AUC 0-∞ , AUC 0-t and C max']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0024826', 'cui_str': 'Marketing'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0012522', 'cui_str': 'Diphenhydramine'}, {'cui': 'C0029309', 'cui_str': 'Orphenadrine'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C3844104', 'cui_str': '450'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0039789', 'cui_str': 'Equivalencies, Therapeutic'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0029309', 'cui_str': 'Orphenadrine'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",28.0,0.0943713,"There were no significant differences observed between the AUC 0-∞ , AUC 0-t and C max of both test and reference preparations in fasted condition.","[{'ForeName': 'Kit Yee', 'Initials': 'KY', 'LastName': 'Cheah', 'Affiliation': 'Clinical Research Ward, Clinical Trial Unit, Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Hospital Ampang, Ampang, Selangor, Malaysia. kityeecheah@hotmail.com.'}, {'ForeName': 'Kar Yee', 'Initials': 'KY', 'LastName': 'Mah', 'Affiliation': 'Clinical Research Ward, Clinical Trial Unit, Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Hospital Ampang, Ampang, Selangor, Malaysia.'}, {'ForeName': 'Lai Hui', 'Initials': 'LH', 'LastName': 'Pang', 'Affiliation': 'Clinical Research Ward, Clinical Trial Unit, Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Hospital Ampang, Ampang, Selangor, Malaysia.'}, {'ForeName': 'Shi Min', 'Initials': 'SM', 'LastName': 'Ng', 'Affiliation': 'Clinical Research Ward, Clinical Trial Unit, Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Hospital Ampang, Ampang, Selangor, Malaysia.'}, {'ForeName': 'Jia Woei', 'Initials': 'JW', 'LastName': 'Wong', 'Affiliation': 'Pharmacy-Attest Research Sdn Bhd BA/BE Centre, George Town, Pulau Pinang, Malaysia.'}, {'ForeName': 'Siew Siew', 'Initials': 'SS', 'LastName': 'Tan', 'Affiliation': 'Pharmacy-Attest Research Sdn Bhd BA/BE Centre, George Town, Pulau Pinang, Malaysia.'}, {'ForeName': 'Hong Zhe', 'Initials': 'HZ', 'LastName': 'Tan', 'Affiliation': 'Pharmacy-Attest Research Sdn Bhd BA/BE Centre, George Town, Pulau Pinang, Malaysia.'}, {'ForeName': 'Kah Hay', 'Initials': 'KH', 'LastName': 'Yuen', 'Affiliation': 'Pharmacy-Attest Research Sdn Bhd BA/BE Centre, George Town, Pulau Pinang, Malaysia.'}]",BMC pharmacology & toxicology,['10.1186/s40360-020-00416-3'] 677,32578478,Inclusion of resistance routines in a hypoxia training program does not interfere with prevention of acute mountain sickness.,"OBJECTIVES Acclimatization strategies have been shown to be the best solutions to avoid acute mountain sickness. In this context, we have designed a protocol performed in hypoxia that includes resistance routines in combination with classical endurance training exercises with mountain trekking at mid altitude. METHODS Thirty-two volunteers preparing different mountain expeditions participated in the study distributed into two groups. One group trained at 2000 m, while another group trained at 4500-5800 m of simulated altitude in a hypoxic chamber. Acute mountain sickness was monitored by answering the Lake Louise Scale questionnaire during 2 sleeping sessions at 4800 m of simulated altitude at the beginning and at the end of the study. At the same time, oxygen saturation was determined in both groups to monitor physiologic adaptation. Data were also collected from the base camps in each expedition before ascension. RESULTS Acute mountain sickness incidence in the hypoxic group decreased from 100% at the beginning to 12% of individuals at the end of the training period, and it was 25% at the base camps of expeditions. On the other hand, the control group passed from 100% to 88% of individuals at the end of the intervention and 70% at the base camps. At the same time, acute mountain sickness severity was mild in the experimental group compared to moderate-severe in the control group. These data were supported by the oxygen saturation values, indicating adequate adaptation changes for altitude in the hypoxic group. CONCLUSION The inclusion of resistance workouts in combination with endurance exercises, all performed in hypoxic conditions, does not interfere with an optimal adaptation to altitude and to prevent acute mountain sickness.",2021,"At the same time, acute mountain sickness severity was mild in the experimental group compared to moderate-severe in the control group.","['with mountain trekking at mid altitude', 'Thirty-two volunteers preparing different mountain expeditions participated in the study, distributed into 2 groups']","['classical endurance training exercises', 'Hypoxia Training Program']","['Acute mountain sickness', 'Lake Louise Scale questionnaire', 'acute mountain sickness severity', 'oxygen saturation', 'Acute mountain sickness incidence']","[{'cui': 'C0442533', 'cui_str': 'Mountain'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0002349', 'cui_str': 'Altitude'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0015315', 'cui_str': 'Expeditions'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0238284', 'cui_str': 'Acute mountain sickness'}, {'cui': 'C0337049', 'cui_str': 'Lake'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",32.0,0.0122975,"At the same time, acute mountain sickness severity was mild in the experimental group compared to moderate-severe in the control group.","[{'ForeName': 'Aritz', 'Initials': 'A', 'LastName': 'Urdampilleta', 'Affiliation': 'ElikaEsport®. Nutrition, Innovation and Sport, Barcelona, Spain.'}, {'ForeName': 'Patxi', 'Initials': 'P', 'LastName': 'León-Guereño', 'Affiliation': 'Department of Psychology, University of Deusto, Bilbao, Spain.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Calleja-González', 'Affiliation': 'Department of Physical Education and Sports, University of Basque Country (UPV-EHU), Vitoria, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Roche', 'Affiliation': 'Department of Applied Biology-Nutrition, Institute of Bioengineering, University Miguel Hernandez (Elche). Alicante Institute for Health and Biomedical Research (ISABIAL), Alicante, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Mielgo-Ayuso', 'Affiliation': 'Department of Biochemistry, Molecular Biology and Physiology, Faculty of Physical Therapy, University of Valladolid, Soria, Spain.'}]",The Physician and sportsmedicine,['10.1080/00913847.2020.1786344'] 678,32574384,Long-term follow-up of human papillomavirus type replacement among young pregnant Finnish females before and after a community-randomised HPV vaccination trial with moderate coverage.,"Large scale human papillomavirus (HPV) vaccination against the most oncogenic high-risk human papillomavirus (HPV) types 16/18 is rapidly reducing their incidence. However, attempts at assessing if this leads to an increase of nonvaccine targeted HPV types have been hampered by several limitations, such as the inability to differentiate secular trends. We performed a population-based serological survey of unvaccinated young women over 12 years. The women were under 23-years-old, residents from 33 communities which participated in a community-randomised trial (CRT) with approximately 50% vaccination coverage. Serum samples were retrieved pre-CRT and post-CRT implementation. Seropositivity to 17 HPV types was assessed. HPV seroprevalence ratios (PR) comparing the postvaccination to prevaccination era were estimated by trial arm. This was also assessed among the sexual risk-taking core group, where type replacement may occur more rapidly. In total, 8022 serum samples from the population-based Finnish Maternity Cohort were retrieved. HPV types 16/18 showed decreased seroprevalence among the unvaccinated in communities only after gender-neutral vaccination (PR 16/18A = 0.8, 95% CI 0.7-0.9). HPV6/11 and HPV73 were decreased after gender-neutral vaccination (PR 6/11A = 0.8, 95% CI 0.7-0.9, PR 73A = 0.7, 95% CI 0.6-0.9, respectively) and girls-only vaccination (PR 6/11B = 0.8, 95% CI 0.7-0.9, PR 73B = 0.9, 95% CI 0.8-1.0). HPV68 alone was increased but only after girls-only vaccination (PR 68B = 1.3, 95% CI 1.0-1.7, PR core68B = 2.8, 95% CI 1.2-6.3). A large-scale, long-term follow-up found no type replacement in the communities with the strongest reduction of vaccine HPV types. Limited evidence for an increase in HPV68 was restricted to girls-only vaccinated communities and may have been due to secular trends (ClinicalTrials.gov number: NCT00534638).",2020,"HPV types 16/18 showed decreased seroprevalence among the unvaccinated in communities only after gender-neutral vaccination (PR 16/18A  = 0.8, 95% CI 0.7-0.9).","['young pregnant Finnish females', '8022 serum samples from the population-based Finnish Maternity Cohort were retrieved in total', 'women were under 23-years-old, residents from 33 communities which participated in a community-randomised trial (CRT) with approximately 50% vaccination coverage', 'unvaccinated young women over 12 years']",['human papillomavirus (HPV) type replacement'],"['HPV6/11 and HPV73', 'HPV68 alone', 'HPV seroprevalence ratios (PR', 'HPV68']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0016134', 'cui_str': 'Finnish language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1550100', 'cui_str': 'Serum specimen'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4505148', 'cui_str': 'Vaccination Coverage'}]","[{'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0600367', 'cui_str': 'Seroprevalence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0730048,"HPV types 16/18 showed decreased seroprevalence among the unvaccinated in communities only after gender-neutral vaccination (PR 16/18A  = 0.8, 95% CI 0.7-0.9).","[{'ForeName': 'Penelope', 'Initials': 'P', 'LastName': 'Gray', 'Affiliation': 'Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Kann', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ville N', 'Initials': 'VN', 'LastName': 'Pimenoff', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Indira', 'Initials': 'I', 'LastName': 'Adhikari', 'Affiliation': 'Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Eriksson', 'Affiliation': 'Research and Development, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Heljä-Marja', 'Initials': 'HM', 'LastName': 'Surcel', 'Affiliation': 'Faculty of Medicine, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Simopekka', 'Initials': 'S', 'LastName': 'Vänskä', 'Affiliation': 'Department of Infectious Disease Control and Vaccination, Inst. for Health & Welfare, Helsinki, Finland.'}, {'ForeName': 'Joakim', 'Initials': 'J', 'LastName': 'Dillner', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Faust', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Lehtinen', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.'}]",International journal of cancer,['10.1002/ijc.33169'] 679,32574478,Single-Sided Deafness-Outcomes of Three Interventions for Profound Unilateral Sensorineural Hearing Loss: A Randomized Clinical Trial.,"OBJECTIVE A comparison of three interventions for profound unilateral sensorineural hearing loss. STUDY DESIGN Prospective, crossover randomized clinical trial. PARTICIPANTS Fifteen participants with profound unilateral sensorineural hearing loss. INTERVENTIONS Three potential technical interventions were compared: Bone Conduction Device on softband, Contralateral Routing of Signal (CROS), and Remote Microphone . Each intervention was randomly trialed for a period of 3 weeks, separated by a 1 week washout period. OUTCOME MEASURES Speech in noise recognition test performed under four conditions (lateral noise poorer ear, lateral noise better ear, speech poorer ear, speech better ear). Standardized questionnaires (Abbreviated Profile of Hearing Aid Benefit, Bern Benefit in Single Sided Deafness Questionnaire, and Speech, Spatial, and Other Qualities 12) were used to evaluate amplification benefit at baseline and following each intervention. RESULTS The use of remote microphone provided the best results in the speech recognition in noise test. A benefit in some signal-to-noise ratios was presented of the CROS over bone conduction device on softband in the Speech Poor Ear condition. On questionnaires of benefit, participants did not rate a particular intervention as significantly better than any other. Following the study, CROS was the intervention preferred by the 8 of 15 participants (53%). The majority of participants (80%) chose to continue with an intervention rather than no treatment. CONCLUSION The use of all interventions resulted in increased performance in speech recognition in noise and rated higher on subjective benefits in comparison with baseline. People with SSD are a heterogeneous population when considering perceived difficulties. Future research should focus on segmenting the population of SSD depending on factors such as etiology, high frequency loss in the better ear, and age of acquired loss for the poorer ear. This stratification may possibly increase the benefit for the patient in terms of more individual-based clinical routines.",2020,The use of all interventions resulted in increased performance in speech recognition in noise and rated higher on subjective benefits in comparison with baseline.,"['Fifteen participants with profound unilateral sensorineural hearing loss', 'Profound Unilateral Sensorineural Hearing Loss']",[],"['Bone Conduction Device on softband, Contralateral Routing of Signal (CROS), and Remote Microphone ', 'Speech in noise recognition test performed under four conditions (lateral noise poorer ear, lateral noise better ear, speech poorer ear, speech better ear', 'performance in speech recognition']","[{'cui': 'C0439808', 'cui_str': 'Profound'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0018784', 'cui_str': 'Sensorineural hearing loss'}]",[],"[{'cui': 'C0005935', 'cui_str': 'Bone conduction'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C1709026', 'cui_str': 'Microphone'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",15.0,0.0614705,The use of all interventions resulted in increased performance in speech recognition in noise and rated higher on subjective benefits in comparison with baseline.,"[{'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Fogels', 'Affiliation': 'Division of Audiology, Department of Health and Rehabilitation, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Sweden.'}, {'ForeName': 'Radi', 'Initials': 'R', 'LastName': 'Jönsson', 'Affiliation': 'Department of Otorhinolaryngology, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Sadeghi', 'Affiliation': 'Division of Audiology, Department of Health and Rehabilitation, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Sweden.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Flynn', 'Affiliation': 'Better Health, Healthcare and Treatment Global Impact Cluster, Research and Innovation, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Traci', 'Initials': 'T', 'LastName': 'Flynn', 'Affiliation': 'School of Humanities and Social Science, Faculty of Education and Arts, University of New Castle, Australia.'}]","Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology",['10.1097/MAO.0000000000002633'] 680,32460997,An international randomized phase III trial of pulse actinomycin-D versus multi-day methotrexate for the treatment of low risk gestational trophoblastic neoplasia; NRG/GOG 275.,"OBJECTIVES Methotrexate and actinomycin-D are both effective first-line drugs for low-risk (WHO score 0-6) Gestational Trophoblastic Neoplasia (GTN) with considerable debate about which is more effective, less toxic, and better tolerated. The primary trial objective was to test if treatment with multi-day methotrexate (MTX) was inferior to pulse actinomycin-D (ACT-D). Secondary objectives included evaluation of severity and frequency of adverse events, and impact on quality of life (QOL). METHODS This was a prospective international cooperative group randomized phase III two arm non-inferiority study (Clinical Trials Identifier: (NCT01535053). The control arm was ACT-D; the experimental arm was multi-day MTX regimen (institutional preference of 5 or 8 day). Outcome measures included complete response rate, recurrence rate, toxicity, and QOL as measured by FACT-G and FACIT supplemental items. RESULTS The complete response rates for multi-day methotrexate and pulse actinomycin-D were 88% (23/26 patients) and 79% (22/28 patients) (p = NS) respectively, there were two recurrences in each arm, and 100% of patients survived. Significant toxicity was minimal, but mouth sores (mucositis), and eye pain were significantly more common in the MTX arm (p = 0.001 and 0.01 respectively). Quality of life showed no significant difference in overall quality of life, body image, sexual function, or treatment related side effects. The study was closed for low accrual rate (target 384, actual accrual 57), precluding statistical analysis of the primary objective. CONCLUSIONS The complete response rate for multi-day methotrexate was higher than actinomycin-D, but did not reach statistical significance. The multi-day MTX regimens were associated with significantly more mucositis and were significantly less convenient.",2020,"The complete response rate for multi-day methotrexate was higher than actinomycin-D, but did not reach statistical significance.",['low risk gestational trophoblastic neoplasia; NRG/GOG 275'],"['pulse actinomycin-D (ACT-D', 'pulse actinomycin-D versus multi-day methotrexate', 'MTX', 'multi-day methotrexate (MTX', 'Methotrexate and actinomycin-D']","['complete response rates', 'mouth sores (mucositis), and eye pain', 'mucositis', 'evaluation of severity and frequency of adverse events, and impact on quality of life (QOL', 'Significant toxicity', 'overall quality of life, body image, sexual function, or treatment related side effects', 'complete response rate, recurrence rate, toxicity, and QOL as measured by FACT-G and FACIT supplemental items', 'complete response rate']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C1135868', 'cui_str': 'Gestational trophoblastic neoplasia'}, {'cui': 'C4517676', 'cui_str': '275'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0010934', 'cui_str': 'Dactinomycin'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0149745', 'cui_str': 'Ulcer of mouth'}, {'cui': 'C0151827', 'cui_str': 'Pain in eye'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.121683,"The complete response rate for multi-day methotrexate was higher than actinomycin-D, but did not reach statistical significance.","[{'ForeName': 'Julian C', 'Initials': 'JC', 'LastName': 'Schink', 'Affiliation': 'Cancer Treatment Centers of America, Comprehensive Care and Research Center, Chicago, IL, USA. Electronic address: Julian.schink@CTCA-hope.com.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Filiaci', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA. Electronic address: FiliaciV@NRGOncology.org.'}, {'ForeName': 'Helen Q', 'Initials': 'HQ', 'LastName': 'Huang', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA. Electronic address: HuangH@NRGOncology.org.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Tidy', 'Affiliation': 'Sheffield Teaching Hospitals, NHS Trust, Royal Hallamshire Hospital, Glossop Rd, Sheffield S10 2JF, UK. Electronic address: John.Tidy@sth.nhs.uk.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Winter', 'Affiliation': 'Sheffield Teaching Hospitals, NHS Trust, Royal Hallamshire Hospital, Glossop Rd, Sheffield S10 2JF, UK. Electronic address: matthew.winter@sth.nhs.uk.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Carter', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, 641 Lexington Avenue, New York, NY, USA. Electronic address: carterj@mskcc.org.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Anderson', 'Affiliation': 'Northwestern University, Chicago, IL, USA. Electronic address: naanders@nm.org.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Moxley', 'Affiliation': 'Oklahoma University Health Science Center, Oklahoma City, OK, USA. Electronic address: Katherine-Moxley@ouhsc.edu.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Yabuno', 'Affiliation': 'Saitama Medical University International Medical Center, Saitama, Japan. Electronic address: yabunoakira@yahoo.co.jp.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Taylor', 'Affiliation': 'Gynecologic Oncology, Magee-Womens Hospital of University of Pittsburgh Medical Center, Pittsburgh, PA, USA. Electronic address: taylorse@upmc.edu.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Kushnir', 'Affiliation': ""Gynecologic Oncology, Women's Cancer Center of Nevada, Las Vegas, NV, USA. Electronic address: ckushnir@wccenter.com.""}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Horowitz', 'Affiliation': 'Harvard Medical School, Massachusetts General Hospital, Boston, MA, USA. Electronic address: nhorowitz@partners.org.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Miller', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA. Electronic address: david.miller@utsouthwestern.edu.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.05.013'] 681,32467522,"Pain Score Assessment Using Single-Dose IV Ketorolac Only, After External Dacryocystorhinostomy: A Randomized Double/Triple-Blind Placebo-Controlled Trial.","PURPOSE To assess efficacy of intravenous (IV) ketorolac for postoperative pain control after external dacryocystorhinostomy. METHOD Fifty-five patients from January to April 2019 were randomized, to a double-blind prospective interventional study. Intervention arm received IV ketorolac (60 mg/2 ml) immediately post-op, control received IV saline bolus. Pain assessment was done with numerical rating scale pre- and postinjection (day 0) and on day 1. Requirement for analgesics and antiemetics was recorded. RESULTS Total 55 patients (11 men and 44 women) with mean age 49.93 ± 16.29 years were included in the study. Twenty-four (43.6%) patients received IV ketorolac and 31 (56.4%) received placebo. Mann-Whitney U test showed mean rank score for pain scale was significantly lower in intervention arm versus control arm, assessed postinjection (16.69 vs. 36.76 respectively, p = .000) and at day 1 (21.08 vs. 33.35 respectively, p = .003). CONCLUSION IV ketorolac significantly lowers self-reported pain score following external dacryocystorhinostomy with reduced requirement of analgesic and antiemetic medications.",2021,"Mann-Whitney U test showed mean rank score for pain scale was significantly lower in intervention arm versus control arm, assessed postinjection (16.69 vs. 36.76 respectively, p = .000) and at day 1 (21.08 vs. 33.35 respectively, p = .003). ","['Total 55 patients (11 men and 44 women) with mean age 49.93 ± 16.29 years were included in the study', 'Fifty-five patients from January to April 2019']","['Placebo', 'intravenous (IV) ketorolac', 'External Dacryocystorhinostomy', 'IV ketorolac', 'ketorolac', 'placebo']","['mean rank score for pain scale', 'postoperative pain control', 'Pain Score Assessment', 'Pain assessment', 'lowers self-reported pain score']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0010931', 'cui_str': 'Dacryocystorhinostomy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",55.0,0.486885,"Mann-Whitney U test showed mean rank score for pain scale was significantly lower in intervention arm versus control arm, assessed postinjection (16.69 vs. 36.76 respectively, p = .000) and at day 1 (21.08 vs. 33.35 respectively, p = .003). ","[{'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Fellow, Sadguru Netra Chikitsalaya.'}, {'ForeName': 'Narendra', 'Initials': 'N', 'LastName': 'Patidar', 'Affiliation': 'Consultant and Head, Orbit and Oculoplasty, Sadguru Netra Chikitsalaya.'}, {'ForeName': 'Harshdeep Singh', 'Initials': 'HS', 'LastName': 'Gabba', 'Affiliation': 'Fellow, Sadguru Netra Chikitsalaya.'}, {'ForeName': 'Devindra', 'Initials': 'D', 'LastName': 'Sood', 'Affiliation': 'Head Academics & Research and Training, Sadguru Netra Chikitsalaya.'}, {'ForeName': 'Parimal', 'Initials': 'P', 'LastName': 'Piush', 'Affiliation': 'Consultant, Orbit and Oculoplasty, Sadguru Netra Chikitsalaya, Chitrakoot, Madhya Pradesh, India.'}]",Ophthalmic plastic and reconstructive surgery,['10.1097/IOP.0000000000001730'] 682,32532581,"Effects of Using an Endotracheal Tube Introducer for Intubation During Mechanical Chest Compressions of a Manikin: Randomized, Prospective, Crossover Study.","BACKGROUND Airway management methods during out-of-hospital cardiac arrest remain controversial. OBJECTIVES This study aimed to compare the impact of using an endotracheal tube introducer with a Macintosh laryngoscope on the first-pass success rates of final-year medical students on a manikin during continuous chest compressions with a mechanical compression device. METHODS Fifty-two final-year students of the faculty of medicine performed endotracheal intubations on a manikin using the Macintosh laryngoscope with and without the endotracheal tube introducer during chest compressions. First-pass success rates, the times of endotracheal intubations, the second endotracheal intubation attempt success rates, and the difficulty level of each method according to the participants' perceptions were measured. RESULTS First-pass success rates did not differ using an endotracheal tube introducer as an adjunct to a Macintosh laryngoscope. Second endotracheal intubation attempt success rates also did not differ by endotracheal tube introducer use. The usage of an endotracheal tube introducer required significantly longer endotracheal intubation time than using only a Macintosh laryngoscope. The perception of difficulty was significantly lower with endotracheal tube introducer use. CONCLUSION The use of an endotracheal tube introducer as an adjunct to a Macintosh laryngoscope is not associated with higher first-pass success rates during mechanical chest compressions in adult simulations performed by final-year medical students. © 2020 Elsevier Inc.",2020,"RESULTS First-pass success rates did not differ using an endotracheal tube introducer as an adjunct to a Macintosh laryngoscope.",['Fifty-two final-year students of the faculty of'],"['endotracheal tube introducer with a Macintosh laryngoscope', 'medicine performed endotracheal intubations on a manikin using the Macintosh laryngoscope with and without the endotracheal tube introducer during chest compressions', 'endotracheal tube introducer', 'Endotracheal Tube Introducer for Intubation']","['perception of difficulty', 'times of endotracheal intubations, the second endotracheal intubation attempt success rates', 'endotracheal intubation time']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}]","[{'cui': 'C0179390', 'cui_str': 'Bougie'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0205436', 'cui_str': 'Second'}]",,0.0210338,"RESULTS First-pass success rates did not differ using an endotracheal tube introducer as an adjunct to a Macintosh laryngoscope.","[{'ForeName': 'Asim Enes', 'Initials': 'AE', 'LastName': 'Ozbek', 'Affiliation': 'Department of Emergency Medicine, University of Health Sciences Kocaeli Derince Training and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Huseyin Cahit', 'Initials': 'HC', 'LastName': 'Halhalli', 'Affiliation': 'Department of Emergency Medicine, University of Health Sciences Kocaeli Derince Training and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Emergency Medicine, Kocaeli University School of Medicine, Kocaeli, Turkey.'}, {'ForeName': 'Emrah', 'Initials': 'E', 'LastName': 'Celik', 'Affiliation': 'Department of Emergency Medicine, University of Health Sciences Kocaeli Derince Training and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Ozerol', 'Affiliation': 'Department of Emergency Medicine, University of Health Sciences Kocaeli Derince Training and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Şancı', 'Affiliation': 'Department of Emergency Medicine, University of Health Sciences Kocaeli Derince Training and Research Hospital, Kocaeli, Turkey.'}]",The Journal of emergency medicine,['10.1016/j.jemermed.2020.04.056'] 683,32535161,Urethra-Sparing Stereotactic Body Radiation Therapy for Prostate Cancer: Quality Assurance of a Randomized Phase 2 Trial.,"PURPOSE To present the radiation therapy quality assurance results from a prospective multicenter phase 2 randomized trial of short versus protracted urethra-sparing stereotactic body radiation therapy (SBRT) for localized prostate cancer. METHODS AND MATERIALS Between 2012 and 2015, 165 patients with prostate cancer from 9 centers were randomized and treated with SBRT delivered either every other day (arm A, n = 82) or once a week (arm B, n = 83); 36.25 Gy in 5 fractions were prescribed to the prostate with (n = 92) or without (n = 73) inclusion of the seminal vesicles (SV), and the urethra planning-risk volume received 32.5 Gy. Patients were treated either with volumetric modulated arc therapy (VMAT; n = 112) or with intensity modulated radiation therapy (IMRT; n = 53). Deviations from protocol dose constraints, planning target volume (PTV) homogeneity index, PTV Dice similarity coefficient, and number of monitor units for each treatment plan were retrospectively analyzed. Dosimetric results of VMAT versus IMRT and treatment plans with versus without inclusion of SV were compared. RESULTS At least 1 major protocol deviation occurred in 51 patients (31%), whereas none was observed in 41. Protocol violations were more frequent in the IMRT group (P < .001). Furthermore, the use of VMAT yielded better dosimetric results than IMRT for urethra planning-risk volume D 98% (31.1 vs 30.8 Gy, P < .0001), PTV D 2% (37.9 vs 38.7 Gy, P < .0001), homogeneity index (0.09 vs 0.10, P < .0001), Dice similarity coefficient (0.83 vs 0.80, P < .0001), and bladder wall V 50% (24.5% vs 33.5%, P = .0001). To achieve its goals volumetric modulated arc therapy required fewer monitor units than IMRT (2275 vs 3378, P <.0001). The inclusion of SV in the PTV negatively affected the rectal wall V 90% (9.1% vs 10.4%, P = .0003) and V 80% (13.2% vs 15.7%, P = .0003). CONCLUSIONS Protocol deviations with potential impact on tumor control or toxicity occurred in 31% of patients in this prospective clinical trial. Protocol deviations were more frequent with IMRT. Prospective radiation therapy quality assurance protocols should be strongly recommended for SBRT trials to minimize potential protocol deviations.",2020,"To achieve its goals VMAT required less MU than IMRT (2275 vs. 3378, p<0.0001).","['Between 2012 and 2015, 165 PCa patients from nine centers', 'localized prostate cancer (PCa', 'prostate cancer']","['radiotherapy quality assurance (RTQA', 'IMRT', 'Urethra-sparing stereotactic body radiotherapy', 'SBRT', 'VMAT vs. IMRT', 'protracted urethra-sparing stereotactic body radiotherapy (SBRT', 'VMAT']","['PTV homogeneity index (HI), PTV Dice similarity coefficient (DSC), and number of monitor units (MU', 'toxicity', 'DSC']","[{'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1512814', 'cui_str': 'Intensity modulated radiation therapy'}, {'cui': 'C0041967', 'cui_str': 'Urethral'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}, {'cui': 'C3489631', 'cui_str': 'Intensity-Modulated Arc Therapy'}]","[{'cui': 'C0454199', 'cui_str': 'Planning target volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",165.0,0.0661156,"To achieve its goals VMAT required less MU than IMRT (2275 vs. 3378, p<0.0001).","[{'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Jaccard', 'Affiliation': 'Radiation Oncology, University Hospital of Geneva, Geneva, Switzerland. Electronic address: maud.jaccard@hcuge.ch.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Zilli', 'Affiliation': 'Radiation Oncology, University Hospital of Geneva, Geneva, Switzerland; Faculty of Medicine, Geneva University, Geneva, Switzerland.'}, {'ForeName': 'Angèle', 'Initials': 'A', 'LastName': 'Dubouloz', 'Affiliation': 'Radiation Oncology, University Hospital of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Lluís', 'Initials': 'L', 'LastName': 'Escude', 'Affiliation': 'Radiation Oncology, Teknon Oncologic Institute, Barcelona, Spain.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Jorcano', 'Affiliation': 'Radiation Oncology, Teknon Oncologic Institute, Barcelona, Spain.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Linthout', 'Affiliation': 'Onze-Lieve-Vrouwziekenhuis, Aalst, Belgium.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Bral', 'Affiliation': 'Onze-Lieve-Vrouwziekenhuis, Aalst, Belgium.'}, {'ForeName': 'Wilko', 'Initials': 'W', 'LastName': 'Verbakel', 'Affiliation': 'Radiation Oncology Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bruynzeel', 'Affiliation': 'Radiation Oncology Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Björkqvist', 'Affiliation': 'Department of Oncology and Radiotherapy, Turku University Hospital, Turku, Finland; Department of Medical Physics, Division of Medical Imaging, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Minn', 'Affiliation': 'Department of Oncology and Radiotherapy, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Lev', 'Initials': 'L', 'LastName': 'Tsvang', 'Affiliation': 'Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Zvi', 'Initials': 'Z', 'LastName': 'Symon', 'Affiliation': 'Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Lencart', 'Affiliation': 'Faculty of Medicine, Geneva University, Geneva, Switzerland.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Oliveira', 'Affiliation': 'Portuguese Institut of Oncology, Porto, Portugal.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Ozen', 'Affiliation': 'Neolife Medical Center, Istanbul, Turkey.'}, {'ForeName': 'Ufuk', 'Initials': 'U', 'LastName': 'Abacioglu', 'Affiliation': 'Neolife Medical Center, Istanbul, Turkey.'}, {'ForeName': 'Juan María', 'Initials': 'JM', 'LastName': 'Pérez-Moreno', 'Affiliation': 'Hospital Universitario Sanchinarro, Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Rubio', 'Affiliation': 'Hospital Universitario Sanchinarro, Madrid, Spain.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Rouzaud', 'Affiliation': 'Radiation Oncology, University Hospital of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Miralbell', 'Affiliation': 'Radiation Oncology, University Hospital of Geneva, Geneva, Switzerland; Faculty of Medicine, Geneva University, Geneva, Switzerland; Radiation Oncology, Teknon Oncologic Institute, Barcelona, Spain.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.06.002'] 684,32535786,The Protective Effects of Butorphanol on Pulmonary Function of Patients with Obesity Undergoing Laparoscopic Bariatric Surgery: a Double-Blind Randomized Controlled Trial.,"BACKGROUND Obesity is a risk factor for postoperative pulmonary complications (PPCs). Recent studies have reported the pulmonary protective role of the kappa opioid receptor (KOR). Butorphanol is a narcotic with strong KOR agonist action, and the role in pulmonary protection is uncertain. Here, we hypothesized that butorphanol exerts protective effects on pulmonary function in patients with obesity undergoing laparoscopic bariatric surgery. METHODS Patients with a body mass index ≥ 30 kg/m 2 scheduled for laparoscopic bariatric surgery were randomized to receive butorphanol or normal saline. Butorphanol was administered as an initial loading dose of 10 μg/kg at 5 min before induction followed by 5 μg/(kg h) during surgery. The primary outcome was arterial-alveolar oxygen tension ratio (a/A ratio). Secondary outcomes included other pulmonary variables, biomarkers reflecting pulmonary injury, and incidence of PPCs within 7 days after surgery. RESULTS Patients in the butorphanol group had a significantly higher a/A ratio at 1 h after the operation began (68 ± 7 vs. 55 ± 8, P < 0.001), end of the operation (73 ± 8 vs. 59 ± 7, P < 0.001), and 1 h after extubation (83 ± 9 vs. 70 ± 5, P < 0.001) compared with those in the control group. In addition, in the butorphanol group, dead space to tidal volume ratios were significantly lower than those in the control group at the same time points (all P < 0.001). In the control group, the levels of biomarkers reflecting pulmonary injury were significantly higher than those in the butorphanol group at 3 h, 6 h, 12 h, and 24 h postoperatively (P < 0.001). The incidence of PPCs was similar in both groups. CONCLUSION Butorphanol administration protected pulmonary function by improving oxygenation and reducing dead space ventilation in patients with obesity undergoing laparoscopic bariatric surgery. Butorphanol may therefore provide clinical benefits in patients with obesity.",2020,"In the control group, the levels of biomarkers reflecting pulmonary injury were significantly higher than those in the butorphanol group at 3 h, 6 h, 12 h, and 24 h postoperatively (P < 0.001).","['m 2 scheduled for laparoscopic bariatric surgery', 'Patients with a body mass index ≥', 'patients with obesity undergoing laparoscopic bariatric surgery', 'patients with obesity', 'Patients with Obesity Undergoing Laparoscopic Bariatric Surgery']","['butorphanol', 'Butorphanol', 'butorphanol or normal saline']","['Pulmonary Function', 'arterial-alveolar oxygen tension ratio (a/A ratio', 'pulmonary variables, biomarkers reflecting pulmonary injury, and incidence of PPCs within 7\xa0days after surgery', 'dead space ventilation', 'pulmonary function', 'dead space to tidal volume ratios', 'incidence of PPCs', 'levels of biomarkers reflecting pulmonary injury']","[{'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0006491', 'cui_str': 'Butorphanol'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0273115', 'cui_str': 'Injury of lung'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.433438,"In the control group, the levels of biomarkers reflecting pulmonary injury were significantly higher than those in the butorphanol group at 3 h, 6 h, 12 h, and 24 h postoperatively (P < 0.001).","[{'ForeName': 'Xiu-Li', 'Initials': 'XL', 'LastName': 'Wang', 'Affiliation': 'Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Zeng', 'Affiliation': ""Department of Anesthesiology, Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, Sichuan, China.""}, {'ForeName': 'Xiao-Xiao', 'Initials': 'XX', 'LastName': 'Li', 'Affiliation': 'Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Xing-He', 'Initials': 'XH', 'LastName': 'Wang', 'Affiliation': 'Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China. w15996933165@163.com.'}]",Obesity surgery,['10.1007/s11695-020-04755-2'] 685,32563188,"GnRH agonist and hCG (dual trigger) versus hCG trigger for final follicular maturation: a double-blinded, randomized controlled study.","STUDY QUESTION Does co-administration of GnRH agonist and Human chorionic gonadotropin (hCG; dual trigger) in IVF cycles improve the number of mature oocytes and pregnancy outcome compared to hCG alone? SUMMARY ANSWER Using the dual trigger for final follicular maturation increases the number of oocytes, mature oocytes and number of blastocysts (total and top-quality) compared to triggering with hCG alone. WHAT IS KNOWN ALREADY hCG is used at the end of controlled ovarian hyperstimulation as a surrogate LH surge to induce final oocyte maturation. Recently, based on retrospective studies, the co-administration of GnRH agonist and hCG for final oocyte maturation (dual trigger) has been suggested to improve IVF outcome and pregnancy rates. STUDY DESIGN, SIZE, DURATION A single center, randomized controlled, double-blinded clinical trial between May 2016 and June 2018 analyzed by intention to treat (ITT). PARTICIPANTS/MATERIALS, SETTINGS, METHODS One hundred and fifty-five normal responder patients were randomized either to receive hCG or dual trigger for final oocyte maturation. Data on patients age, BMI, AMH, number of oocytes retrieved, number of metaphase 2 (MII) oocytes, zygotes and blastocysts, clinical pregnancy rate and live birth rate were assessed and compared between the dual trigger group and the hCG group. We performed a planned interim analysis after the recruitment of 50% of the patients. Based on the totality of outcomes at the interim analysis we decided to discontinue further recruitment. MAIN RESULTS AND THE ROLE OF CHANCE One hundred and fifty-five patients were included in the study. The age (36 years versus 35.3 years P = NS), BMI (24 kg/m2 versus 23.7 kg/m2) and the AMH (20.1 pmol/l versus 22.4 pmol/l) were comparable between the two groups. Based on ITT analysis, the number of eggs retrieved (11.1 versus 13.4, P = 0.002), the MII oocytes (8.6 versus 10.3, P = 0.009), total number of blastocysts (2.9 versus 3.9, P = 0.01) and top-quality blastocysts transferred (44.7% versus 64.9%; P = 0.003) were significantly higher in the dual trigger group compared to the hCG group. The clinical pregnancy rate (24.3% versus 46.1%, OR 2.65 (1.43-1.93), P = 0.009) and the live birth rate per transfer (22% versus 36.2%, OR= 1.98 (1.05-3.75), P = 0.03) were significantly higher in the dual trigger group compared to the hCG group. LIMITATIONS, REASONS FOR CAUTION None. WIDER IMPLICATIONS OF THE FINDINGS The enhanced response observed with the dual trigger might lead to better IVF outcomes were it used more widely. STUDY FUNDING/COMPETING INTEREST(S) The study was funded by TRIO Fertility. There are no conflicts of interest to declare. TRIAL REGISTRATION NUMBER ClinicalTrials.gov identifier: NCT02703584. DATE OF TRIAL REGISTRATION March 2016. DATE OF FIRST PATIENT'S ENROLLMENT May 2016.",2020,"Based on ITT analysis, the number of eggs retrieved (11.1 versus 13.4, P = 0.002), the MII oocytes (8.6 versus 10.3, P = 0.009), total number of blastocysts (2.9 versus 3.9, P = 0.01) and top-quality blastocysts transferred (44.7% versus 64.9%; P = 0.003) were significantly higher in the dual trigger group compared to the hCG group.","['One hundred and fifty-five normal responder patients', 'One hundred and fifty-five patients were included in the study', 'May 2016 and June 2018 analyzed by intention to treat (ITT', 'The age (36 years versus 35.3 years P = NS), BMI (24 kg/m2 versus 23.7 kg/m2) and the AMH (20.1 pmol/l versus 22.4 pmol/l']","['GnRH agonist and Human chorionic gonadotropin (hCG', 'hCG', 'GnRH agonist and hCG (dual trigger) versus hCG', 'GnRH agonist and hCG']","['number of oocytes, mature oocytes and number of blastocysts (total and top-quality', 'total number of blastocysts', 'clinical pregnancy rate', 'BMI, AMH, number of oocytes retrieved, number of metaphase 2 (MII) oocytes, zygotes and blastocysts, clinical pregnancy rate and live birth rate', 'IVF outcome and pregnancy rates', 'live birth rate per transfer', 'MII oocytes']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0162874', 'cui_str': 'Amharic language'}, {'cui': 'C0439284', 'cui_str': 'pmol/L'}]","[{'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}]","[{'cui': 'C0449803', 'cui_str': 'Number of oocytes'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1281743', 'cui_str': 'Blastocyst structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0162874', 'cui_str': 'Amharic language'}, {'cui': 'C1621812', 'cui_str': 'Metaphase'}, {'cui': 'C0043544', 'cui_str': 'Structure of zygote'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}]",155.0,0.308413,"Based on ITT analysis, the number of eggs retrieved (11.1 versus 13.4, P = 0.002), the MII oocytes (8.6 versus 10.3, P = 0.009), total number of blastocysts (2.9 versus 3.9, P = 0.01) and top-quality blastocysts transferred (44.7% versus 64.9%; P = 0.003) were significantly higher in the dual trigger group compared to the hCG group.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Haas', 'Affiliation': 'TRIO Fertility, Toronto, ON, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bassil', 'Affiliation': 'TRIO Fertility, Toronto, ON, Canada.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Samara', 'Affiliation': 'TRIO Fertility, Toronto, ON, Canada.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Zilberberg', 'Affiliation': 'TRIO Fertility, Toronto, ON, Canada.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mehta', 'Affiliation': 'TRIO Fertility, Toronto, ON, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Orvieto', 'Affiliation': 'IVF Unit, Department of Obstetrics and Gynecology, Chaim Sheba Medical Center, Tel-Hashomer, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'R F', 'Initials': 'RF', 'LastName': 'Casper', 'Affiliation': 'TRIO Fertility, Toronto, ON, Canada.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa107'] 686,32562573,"Genetic Variation in PEAR1, Cardiovascular Outcomes and Effects of Aspirin in a Healthy Elderly Population.","The platelet endothelial aggregation receptor-1 (PEAR1) rs12041331 variant has been identified as a genetic determinant of platelet aggregation in response to antiplatelet therapies, including aspirin. However, association with atherothrombotic cardiovascular events is less clear, with limited evidence from large trials. Here, we tested association of rs12041331 with cardiovascular events and aspirin use in a randomized trial population of healthy older individuals. We undertook post hoc analysis of 13,547 participants of the ASPirin in Reducing Events in the Elderly (ASPREE) trial, median age 74 years. Participants had no previous diagnosis of atherothrombotic cardiovascular disease at enrollment, and were randomized to either 100 mg daily low-dose aspirin or placebo for median 4.7 years follow-up. We used Cox proportional hazard regression to model the relationship between rs12041331 and the ASPREE primary cardiovascular disease (CVD) end point, and composites of major adverse cardiovascular events (MACE) and ischemic stroke (STROKE); and bleeding events; major hemorrhage (MHEM) and intracranial bleeding (ICB). We performed whole-population analysis using additive and dominant inheritance models, then stratified by treatment group. Interaction effects between genotypes and treatment group were examined. We observed no statistically significant association (P < 0.05) in the population, or by treatment group, between rs12041331 and cardiovascular or bleeding events in either model. We also found no significant interaction effects between rs12041331-A and treatment group, for CVD (P = 0.65), MACE (P = 0.32), STROKE (P = 0.56), MHEM (P = 0.59), or ICB (P = 0.56). The genetic variant PEAR1 rs12041331 is not associated with cardiovascular events in response to low-dose aspirin in a healthy elderly population.",2020,The genetic variant PEAR1 rs12041331 is not associated with cardiovascular events in response to low-dose aspirin in a healthy elderly population.,"['healthy older individuals', 'Participants had no previous diagnosis of atherothrombotic cardiovascular disease at enrolment', 'healthy elderly population', 'N=13,547 participants of the ASPirin in Reducing Events in the Elderly (ASPREE) trial, median age 74 years']","['aspirin', 'aspirin or placebo']","['cardiovascular disease endpoint (CVD), and composites of major adverse cardiovascular events (MACE) and ischaemic stroke (STROKE); and bleeding events; major hemorrhage (MHEM) and intracranial bleeding (ICB', 'Interaction effects', 'rs12041331 and cardiovascular or bleeding events']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332132', 'cui_str': 'Prior diagnosis'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}]",13547.0,0.0373115,The genetic variant PEAR1 rs12041331 is not associated with cardiovascular events in response to low-dose aspirin in a healthy elderly population.,"[{'ForeName': 'Joshua P', 'Initials': 'JP', 'LastName': 'Lewis', 'Affiliation': 'Department of Medicine, Program for Personalized and Genomic Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Moeen', 'Initials': 'M', 'LastName': 'Riaz', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Xie', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Polekhina', 'Affiliation': 'Department of Medicine, Program for Personalized and Genomic Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Nelson', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Tonkin', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Murray', 'Affiliation': 'Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare, Minneapolis, Minnesota, USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Alan R', 'Initials': 'AR', 'LastName': 'Shuldiner', 'Affiliation': 'Department of Medicine, Program for Personalized and Genomic Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lacaze', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1959'] 687,32567065,Effectiveness of the WeChat-based smoking cessation intervention ('WeChat WeQuit' program) in China: study protocol for a randomized controlled trial.,"BACKGROUND AND AIMS Since its first release in 2011, WeChat (Chinese pinyin: Wei Xin) has been widely used to promote health. As the most popular all-in-one social media application providing free instant messaging, voice, text, pictures, videos and location information exchange via smartphone, WeChat holds promise for delivering smoking cessation services to a large number of people at low unit cost in China, a country with more than 300 million smokers. This protocol is for a study that aims to assess the efficacy of a WeChat-based smoking cessation intervention ('WeChat WeQuit') for treatment-seeking smokers in China. DESIGN In this two-arm randomized controlled trial (RCT), the control group will receive only a digital version of a booklet of 'Happy Quit'. The intervention group will also receive the 2 weeks pre- and 12 weeks post-quit 'WeChat WeQuit' intervention. Both groups will be followed-up to 26 weeks (6 months) after quit day. SETTING This on-line trial has no restrictions on setting or location. PARTICIPANTS Chinese-speaking current smokers (have smoked ≥100 cigarettes in their life-time and currently smoke cigarettes) aged 18+ years willing to make a quit attempt within 1 month (n = 2000) will be recruited by on- and off-line advertising. Potential participants will register their interest by sending WeChat messages or text messages, or making a voice call. MEASUREMENTS The primary outcome measure is self-reported 26-week continuous smoking abstinence with biological verification [test by clinic visit: expired carbon monoxide concentration <10 parts per million (p.p.m.) or by mailing cotinine urine dipsticks: urine cotinine <200 ng/ml]. Secondary outcome measures include: 7-day point prevalence abstinence at weeks 1, 4, 8, 12, 16, 20 and 26 after-quit day; self-reported 12-week continuous smoking abstinence and 26-week continuous smoking abstinence; reductions in number of cigarettes smoked per day; and rates of participation in and completion of the smoking-cessation program. CONCLUSIONS If the 'WeChat WeQuit' program is found to be effective, it will be an accessible, affordable and widely implementable intervention to help cigarette smokers to quit. The potential public health impact of its expansion into underserved regions or communities is considerable.",2021,"In this two-arm randomized controlled trial (RCT), the control group will receive only a digital version of a booklet of ""Happy Quit"".","['Chinese-speaking current smokers (smoked ≥ 100 cigarettes in the lifetime and currently smokes cigarettes) aged 18+, willing to make a quit attempt within 1 month (n = 2000) will be recruited by on-line and off-line advertising', 'treatment seeking smokers in China']","['WeChat-based smoking cessation intervention (""WeChat WeQuit', 'WeChat-based Smoking Cessation intervention (""WeChat WeQuit"" program']","[' 7-day point prevalence abstinence', 'continuous smoking abstinence and 26-week continuous smoking abstinence; reductions in number of cigarettes smoked per day; and rates of participation in and completion of smoking-cessation program', 'self-reported 26-week continuous smoking abstinence with biological verification (test by clinic visit: expired carbon monoxide concentration < 10 ppm or by mailing cotinine urine dipsticks: urine cotinine < 200 ng/ml']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0001690', 'cui_str': 'Advertising as Topic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0010194', 'cui_str': 'Cotinine'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0441090', 'cui_str': 'Dipstick'}, {'cui': 'C1697737', 'cui_str': 'Urine cotinine test'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]",,0.0682711,"In this two-arm randomized controlled trial (RCT), the control group will receive only a digital version of a booklet of ""Happy Quit"".","[{'ForeName': 'Yanhui', 'Initials': 'Y', 'LastName': 'Liao', 'Affiliation': 'Department of Psychiatry, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Zhejiang, Hangzhou, China.'}, {'ForeName': 'Yunfei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Psychiatry, the Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Yueheng', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Psychiatry, the Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'McNeill', 'Affiliation': ""Addictions Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Jinsong', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Department of Psychiatry, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Zhejiang, Hangzhou, China.'}]","Addiction (Abingdon, England)",['10.1111/add.15166'] 688,32567996,Analysis of subjective perception and influencing factors of different inclusive education models among prelingually deaf children with a cochlear implant.,"OBJECTIVE We aimed to explore the educational outcome and influencing factors of ongoing verbal rehabilitation training together with inclusive education among prelingually deaf children with a cochlear implant. METHODS Prelingually deaf children who underwent cochlear implantation, rehabilitation, and had inclusive education placement were randomly divided into two groups: one group received continuous verbal rehabilitation training under inclusive education status; the other group did not receive this training. Speech discrimination scores were determined. RESULTS Among 60 included children, subjectively perceived academic adaptability, peer relations, initiative communication, and teacher's involvement under inclusive education, as well as speech discrimination scores, were all significantly different between groups. Continuous verbal rehabilitation training influenced the subjective perception of children and resulted in higher speech discrimination scores and more positive subjective perception. Subjective perception was not significantly correlated with chronological age, sex, age at the time of cochlear implantation, or duration of inclusive education. CONCLUSION Ongoing verbal rehabilitation training within inclusive education can largely improve the education placement outcomes of prelingually deaf children with cochlear implants.",2020,Ongoing verbal rehabilitation training within inclusive education can largely improve the education placement outcomes of prelingually deaf children with cochlear implants.,"['prelingually deaf children with cochlear implants', 'Prelingually deaf children who underwent cochlear implantation, rehabilitation, and had inclusive education placement', 'prelingually deaf children with a cochlear implant']","['continuous verbal rehabilitation training under inclusive education status; the other group did not receive this training', 'verbal rehabilitation training', 'Continuous verbal rehabilitation training']","['Speech discrimination scores', 'positive subjective perception', 'Subjective perception', ""subjectively perceived academic adaptability, peer relations, initiative communication, and teacher's involvement under inclusive education, as well as speech discrimination scores"", 'higher speech discrimination scores']","[{'cui': 'C0525064', 'cui_str': 'Hearing Impaired Persons'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009199', 'cui_str': 'Cochlear prosthesis'}, {'cui': 'C0302559', 'cui_str': 'Implantation of cochlear prosthetic device'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0557305', 'cui_str': 'Educated at mainstream school'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0557305', 'cui_str': 'Educated at mainstream school'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0429202', 'cui_str': 'Speech discrimination score'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0557305', 'cui_str': 'Educated at mainstream school'}, {'cui': 'C0205250', 'cui_str': 'High'}]",60.0,0.0144398,Ongoing verbal rehabilitation training within inclusive education can largely improve the education placement outcomes of prelingually deaf children with cochlear implants.,"[{'ForeName': 'Xiao-Feng', 'Initials': 'XF', 'LastName': 'Qiao', 'Affiliation': ""Department of Otorhinolaryngology, Shanxi Provincial People's Hospital Affiliated to Shanxi Medical University, Taiyuan, China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Ren', 'Affiliation': 'Shanxi University of Chinese Medicine, Taiyuan, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Otorhinolaryngology, Shanxi Provincial People's Hospital Affiliated to Shanxi Medical University, Taiyuan, China.""}, {'ForeName': 'Tong-Li', 'Initials': 'TL', 'LastName': 'Li', 'Affiliation': ""Department of Otorhinolaryngology, Shanxi Provincial People's Hospital Affiliated to Shanxi Medical University, Taiyuan, China.""}, {'ForeName': 'Redentor S', 'Initials': 'RS', 'LastName': 'Mariano', 'Affiliation': 'Jose Rizal University, Mandaluyong City, Philippines.'}]",The Journal of international medical research,['10.1177/0300060520929855'] 689,32564459,"Single- vs multiple-layer wound closure for flank incisions: results of a prospective, randomised, double-blinded multicentre study.","OBJECTIVE To compare the incidence of postoperative flank bulges between patients with multiple-layer closure and single superficial-layer closure after retroperitoneal surgery via open flank incision in the SIngle versus MUltiple-LAyer wound Closure for flank incision (SIMULAC) trial. PATIENTS AND METHODS The study was a randomised controlled, patient- and assessor-blinded, multicentre trial. Between May 2015 and February 2017, 225 patients undergoing flank incisions were randomised 1:1 to a multiple-layer closure (SIMULAC-I) or a single superficial-layer closure (SIMULAC-II) group. The primary outcome was the occurrence of a flank bulge 6 months after surgery. RESULTS Overall, 177 patients (90 in SIMULAC-I, 87 in SIMULAC-II) were eligible for final assessment. The cumulative incidence of a flank bulge was significantly higher in the SIMULAC-II group (51.7%) compared to the SIMULAC-I group [34.4%; odds ratio (OR) 2.04, 95% confidence interval (CI) 1.11-3.73; P = 0.02]. Rate of severe postoperative complications (4.4% SIMULAC-I vs 10.3% SIMULAC-II; P = 0.21) or hernia (6.7% SIMULAC-I vs 10.3% SIMULAC-II; P = 0.59) was similar between the groups. There was no difference in pain (visual analogue scale) and the requirement for pain medication at 6 months postoperatively. Quality of life assessed with the European Quality of Life 5 Dimensions Questionnaire was higher in the SIMULAC-I group compared to the SIMULAC-II group at 6 months postoperatively, with a (median range) score of 80 (30-100) vs 75 (5-100) (P = 0.012). CONCLUSION The overall risk of a flank bulge after flank incision is high. Multiple-layer closure after flank incision should be performed as a standard procedure.",2021,"Quality of life assessed with the EQ-5D was higher in the SIMULAC-I group compared to the SIMULAC-II group 6 months postoperatively (80 [30-100] vs. 75 [5-100]; P = 0.012). ","['patients with multiple-layer closure and single superficial-layer closure after retroperitoneal surgery via open flank incision', '177 patients (90 SIMULAC-I, 87 SIMULAC-II) were eligible for final assessment', 'Between May 2015 and February 2017, 225 patients undergoing flank incision']","['Single-layered versus multiple-layered wound closure for flank incision', 'multiple-layered closure (SIMULAC-I) and a single superficial layered closure (SIMULAC-II) group']","['overall risk of a flank bulge', 'Rate of severe postoperative complications', 'occurrence of a flank bulge 6 months after surgery', 'pain (visual analogue scale', 'cumulative incidence of a flank bulge', 'hernia', 'Quality of life assessed with the EQ-5D']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0035359', 'cui_str': 'Retroperitoneal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0198492', 'cui_str': 'Incision of flank'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4517652', 'cui_str': '225'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}, {'cui': 'C0198492', 'cui_str': 'Incision of flank'}, {'cui': 'C1293123', 'cui_str': 'Layered closure - action'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0230171', 'cui_str': 'Structure of lateral region of abdomen'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",225.0,0.134905,"Quality of life assessed with the EQ-5D was higher in the SIMULAC-I group compared to the SIMULAC-II group 6 months postoperatively (80 [30-100] vs. 75 [5-100]; P = 0.012). ","[{'ForeName': 'Maximilian C', 'Initials': 'MC', 'LastName': 'Kriegmair', 'Affiliation': 'Department of Urology and Urosurgery, University Hospital Manheim, Mannheim, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Younsi', 'Affiliation': 'Department of Urology and Urosurgery, University Hospital Manheim, Mannheim, Germany.'}, {'ForeName': 'Kiriaki', 'Initials': 'K', 'LastName': 'Hiller', 'Affiliation': 'Department of Urology and Urosurgery, University Hospital Manheim, Mannheim, Germany.'}, {'ForeName': 'Conrad', 'Initials': 'C', 'LastName': 'Leitsmann', 'Affiliation': 'Department of Urology, University Hospital Göttingen, Göttingen, Germany.'}, {'ForeName': 'Karl F', 'Initials': 'KF', 'LastName': 'Kowalewski', 'Affiliation': 'Department of Urology and Urosurgery, University Hospital Manheim, Mannheim, Germany.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Siegel', 'Affiliation': 'Department of Urology and Urosurgery, University Hospital Manheim, Mannheim, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Rothamel', 'Affiliation': 'Urological Hospital Munich-Planegg, Planegg, Germany.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ritter', 'Affiliation': 'Department of Urology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Bolenz', 'Affiliation': 'Department of Urology, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kriegmair', 'Affiliation': 'Urological Hospital Munich-Planegg, Planegg, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Trojan', 'Affiliation': 'Department of Urology, University Hospital Göttingen, Göttingen, Germany.'}, {'ForeName': 'Maurice S', 'Initials': 'MS', 'LastName': 'Michel', 'Affiliation': 'Department of Urology and Urosurgery, University Hospital Manheim, Mannheim, Germany.'}]",BJU international,['10.1111/bju.15148'] 690,32565534,Use of Various Doses of S-Ketamine in Treatment of Depression and Pain in Cervical Carcinoma Patients with Mild/Moderate Depression After Laparoscopic Total Hysterectomy.,"BACKGROUND This study investigated the effects of various doses of S-ketamine on depression and pain management of cervical carcinoma patients with mild/moderate depression. MATERIAL AND METHODS This randomized, double-blind, controlled study included 417 cervical carcinoma patients who received laparoscopic modified radical hysterectomy from April 2015 to July 2018 and who also had mild/moderate depression symptoms based on HAMD-17 scores (8~24). All patients were randomized into 4 groups: 1) the control group, 2) the racemic ketamine group, 3) the high-dose S-ketamine group; and 4) the low-dose S-ketamine group. Pain was assessed using the Visual Analogue Score (VAS), and depression was assessed using theHAMD-17 score. Serum levels of BDNF and 5-HT were measured. RESULTS The 4 groups of patients showed no significant differences in operation time, bleeding volume, hospitalization duration, or complications. The high-dose S-ketamine group showed significantly lower VAS and HAMD-17 scores than all other groups at 1 day and 3 days postoperatively, but no differences were observed in the low-dose S-ketamine group and the racemic ketamine group. The high-dose S-ketamine group showed significantly higher serum BDNF and 5-HT levels at 1 day and 3 days after surgery. However, 1 week after surgery, no difference was observed in any of the treatment groups. CONCLUSIONS At subanesthetic dose, both 0.5 mg/kg and 0.25 mg/kg S-ketamine improved short-term depression and pain for cervical carcinoma patients after surgery, and the effects were better than with the same dose of racemic ketamine.",2020,"The high-dose S-ketamine group showed significantly lower VAS and HAMD-17 scores than all other groups at 1 day and 3 days postoperatively, but no differences were observed in the low-dose S-ketamine group and the racemic ketamine group.","['cervical carcinoma patients after surgery', 'cervical carcinoma patients with mild/moderate depression', 'from April 2015 to July 2018 and who also had mild/moderate depression symptoms based on HAMD-17 scores (8~24', 'Cervical Carcinoma Patients with Mild/Moderate Depression', '417 cervical carcinoma patients who received']","['racemic ketamine group, 3) the high-dose S-ketamine group; and 4) the low-dose S-ketamine', 'racemic ketamine', 'ketamine', 'laparoscopic modified radical hysterectomy', 'S-ketamine', 'S-Ketamine']","['short-term depression and pain', 'serum BDNF and 5-HT levels', 'Pain', 'Depression and Pain', 'Visual Analogue Score (VAS), and depression', 'Serum levels of BDNF and 5-HT', 'VAS and HAMD-17 scores', 'depression and pain management', 'operation time, bleeding volume, hospitalization duration, or complications']","[{'cui': 'C0302592', 'cui_str': 'Carcinoma of cervix'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0588007', 'cui_str': 'Moderate depression'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C5191297', 'cui_str': '417'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C2825616', 'cui_str': 'esketamine'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0559248', 'cui_str': 'Modified radical'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",417.0,0.0808004,"The high-dose S-ketamine group showed significantly lower VAS and HAMD-17 scores than all other groups at 1 day and 3 days postoperatively, but no differences were observed in the low-dose S-ketamine group and the racemic ketamine group.","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, Ninth People's Hospital of Suzhou, Suzhou, Jiangsu, China (mainland).""}, {'ForeName': 'Yajun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, Xishan People's Hospital, Wuxi, Jiangsu, China (mainland).""}, {'ForeName': 'Xudong', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, Changzhou Traditional Chinese Medicine Hospital, Changzhou, Jiangsu, China (mainland).'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Peng', 'Affiliation': ""Department of Anesthesiology, Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine (TCM), Shanghai, China (mainland).""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, Shanghai Gongli Hospital, Second Military Medical University, Shanghai, China (mainland).'}, {'ForeName': 'Peirong', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': ""Department of Anesthesiology, Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine (TCM), Shanghai, China (mainland).""}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.922028'] 691,32569102,Effects of Massage on Post-Operative Pain in Infants with Complex Congenital Heart Disease.,"BACKGROUND Pain management is an essential component of care for pediatric patients following surgery. Massage reduces self-reported post-operative pain in adults with heart disease but has received little attention in post-operative pediatric patients with congenital heart disease (CCHD). OBJECTIVES To evaluate the effectiveness of massage compared to a rest period on post-operative pain scores and physiologic responses in infants with CCHD. METHODS We used a two-group randomized clinical trial design with a sample of 60 infants with CCHD between 1 day and 12 months of age following their first cardiothoracic surgery. Both groups received standard post-operative care. Group 1 received a daily 30-minute restriction of non-essential caregiving (Quiet Time), and Group 2 received a daily 30-minute massage. Interventions continued for seven consecutive days. Pain was measured 6 times daily using the Face, Legs, Activity, Cry, Consolability Pain Assessment Tool (FLACC). Average daily doses of analgesics were recorded. Heart rates (HR), respiratory rates (RR), and oxygen saturations (SpO2) were recorded continuously. Daily averages and pre- and post- intervention FLACC scores and physiologic responses were analyzed using descriptive statistics, GLMM repeated measures, latent growth models, and/or regression discontinuity analysis. Fentanyl-equivalent narcotic values were used as a time-varying covariate. RESULTS Adjusted pain scores were lower for the massage group on all days except day 7. Overall there were no group effects on level of pain or differential rate of change in pain. However, the massage group had lower daily pain scores with small to medium effect size differences, largest at days 4, 5 and 6, and lower average daily HR and RR. There was little difference between groups in SpO2. Infants demonstrated immediate effects of massage, with HR and RR decreasing and oxygen saturations increasing. DISCUSSION This study provides beginning evidence that post-operative massage may reduce pain and improve physiologic parameters in infants with congenital heart disease. This non-pharmacological adjunct to pain management may provide a particular benefit for this population by reducing demand on the cardiorespiratory system.",2020,"However, the massage group had lower daily pain scores with small to medium effect size differences, largest at days 4, 5 and 6, and lower average daily HR and RR.","['infants with CCHD', 'adults with heart disease', 'pediatric patients with congenital heart disease (CCHD', 'infants with congenital heart disease', 'pediatric patients following surgery', '60 infants with CCHD between 1 day and 12 months of age following their first cardiothoracic surgery', 'Infants with Complex Congenital Heart Disease']","['standard post-operative care', 'daily 30-minute restriction of non-essential caregiving (Quiet Time), and Group 2 received a daily 30-minute massage', 'Fentanyl-equivalent narcotic values', 'Massage']","['Daily averages and pre- and post- intervention FLACC scores and physiologic responses', 'Heart rates (HR), respiratory rates (RR), and oxygen saturations (SpO2', 'Pain', 'Face, Legs, Activity, Cry, Consolability Pain Assessment Tool (FLACC', 'immediate effects of massage, with HR and RR decreasing and oxygen saturations increasing', 'daily pain scores', 'Adjusted pain scores', 'level of pain or differential rate of change in pain']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1274037', 'cui_str': 'Cardiothoracic surgery'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205224', 'cui_str': 'Essential'}, {'cui': 'C0439654', 'cui_str': 'Quiet'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0231837', 'cui_str': 'Slow respiration'}, {'cui': 'C0852710', 'cui_str': 'Oxygen saturation increased'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",60.0,0.174636,"However, the massage group had lower daily pain scores with small to medium effect size differences, largest at days 4, 5 and 6, and lower average daily HR and RR.","[{'ForeName': 'Tondi M', 'Initials': 'TM', 'LastName': 'Harrison', 'Affiliation': ""The Ohio State University College of Nursing, Columbus, Ohio University of Wisconsin-Madison School of Nursing, Madison, Wisconsin Nationwide Children's Hospital, Columbus, Ohio Nationwide Children's Hospital, Columbus, Ohio COPC Ohio Center for Pediatrics, Dublin, Ohio The Ohio State University College of Nursing, Columbus, Ohio Nationwide Children's Hospital, Columbus, Ohio Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Duffey', 'Affiliation': ''}, {'ForeName': 'Corrie', 'Initials': 'C', 'LastName': 'Frey', 'Affiliation': ''}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bailey', 'Affiliation': ''}, {'ForeName': 'Marliese Dion', 'Initials': 'MD', 'LastName': 'Nist', 'Affiliation': ''}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Renner', 'Affiliation': ''}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Fitch', 'Affiliation': ''}]",Nursing research,['10.1097/NNR.0000000000000459'] 692,32574587,"Efficacy and safety of dupilumab with concomitant topical corticosteroids in children 6 to 11 years old with severe atopic dermatitis: A randomized, double-blinded, placebo-controlled phase 3 trial.","BACKGROUND Children with severe atopic dermatitis (AD) have limited treatment options. OBJECTIVE We report the efficacy and safety of dupilumab + topical corticosteroids (TCS) in children aged 6-11 years with severe AD inadequately controlled with topical therapies. METHODS In this double-blind, 16-week, phase 3 trial (NCT03345914), 367 patients were randomized 1:1:1 to 300 mg dupilumab every 4 weeks (300 mg q4w), a weight-based regimen of dupilumab every 2 weeks (100 mg q2w, baseline weight <30 kg; 200 mg q2w, baseline weight ≥30 kg), or placebo; with concomitant medium-potency TCS. RESULTS Both the q4w and q2w dupilumab + TCS regimens resulted in clinically meaningful and statistically significant improvement in signs, symptoms, and quality of life (QOL) versus placebo + TCS in all prespecified endpoints. For q4w, q2w, and placebo, 32.8%, 29.5%, and 11.4% of patients, respectively, achieved Investigator's Global Assessment scores of 0 or 1; 69.7%, 67.2%, and 26.8% achieved ≥75% improvement in Eczema Area and Severity Index scores; and 50.8%, 58.3%, and 12.3% achieved ≥4-point reduction in worst itch score. Response to therapy was weight-dependent: optimal dupilumab doses for efficacy and safety were 300 mg q4w in children <30 kg and 200 mg q2w in children ≥30 kg. Conjunctivitis and injection-site reactions were more common with dupilumab + TCS than with placebo + TCS. LIMITATIONS Short-term 16-week treatment period; severe AD only. CONCLUSION Dupilumab + TCS is efficacious and well tolerated in children with severe AD, significantly improving signs, symptoms, and QOL.",2020,"Both the q4w and q2w dupilumab+TCS regimens resulted in clinically meaningful and statistically significant improvement in signs, symptoms, and quality of life (QoL) versus placebo+TCS in all prespecified endpoints.","['children aged 6-11 years with severe AD inadequately controlled with topical therapies', 'Children with severe atopic dermatitis (AD', '367 patients', 'children with severe AD', 'children 6 to 11 years old with severe atopic dermatitis']","['Dupilumab+TCS', 'dupilumab with concomitant topical corticosteroids', 'placebo; with concomitant medium-potency TCS', 'dupilumab+TCS', 'dupilumab + topical corticosteroids (TCS', 'placebo']","['signs, symptoms, and quality of life (QoL', 'Eczema Area and Severity Index scores', 'Efficacy and safety', 'efficacy and safety', 'Conjunctivitis and injection-site reactions', ""Investigator's Global Assessment scores""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}]","[{'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009763', 'cui_str': 'Conjunctivitis'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}]",367.0,0.54447,"Both the q4w and q2w dupilumab+TCS regimens resulted in clinically meaningful and statistically significant improvement in signs, symptoms, and quality of life (QoL) versus placebo+TCS in all prespecified endpoints.","[{'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Paller', 'Affiliation': ""Northwestern University Feinberg School of Medicine, Chicago, Illinois; Ann and Robert H. Lurie Children's Hospital, Chicago, Illinois.""}, {'ForeName': 'Elaine C', 'Initials': 'EC', 'LastName': 'Siegfried', 'Affiliation': ""Saint Louis University, St. Louis, Missouri; Cardinal Glennon Children's Hospital, St. Louis, Missouri.""}, {'ForeName': 'Diamant', 'Initials': 'D', 'LastName': 'Thaçi', 'Affiliation': 'Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wollenberg', 'Affiliation': 'Ludwig-Maximilian University, Munich, Germany.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Cork', 'Affiliation': 'University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Arkwright', 'Affiliation': 'Lydia Becker Institute of Immunology and Inflammation, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Gooderham', 'Affiliation': ""Probity Medical Research, Peterborough, Ontario, Canada; SKiN Centre for Dermatology, Peterborough, Ontario, Canada; Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Beck', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Boguniewicz', 'Affiliation': 'National Jewish Health, Denver, Colorado; University of Colorado School of Medicine, Denver, Colorado.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Sher', 'Affiliation': 'Peninsula Research Associates, Rolling Hills Estates.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Weisman', 'Affiliation': 'Advanced Medical Research, PC, Atlanta, California.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': ""O'Malley"", 'Affiliation': 'Sanofi, Cambridge, Massachusetts.'}, {'ForeName': 'Naimish', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'Sanofi, Cambridge, Massachusetts.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Hardin', 'Affiliation': 'Sanofi, Cambridge, Massachusetts.'}, {'ForeName': 'Neil M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown New York.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Ruddy', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown New York.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown New York.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Davis', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown New York.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Kamal', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown New York.'}, {'ForeName': 'Faisal A', 'Initials': 'FA', 'LastName': 'Khokhar', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown New York.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Weinreich', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown New York.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Yancopoulos', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown New York.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Beazley', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown New York.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Bansal', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown New York.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Shumel', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown New York. Electronic address: Brad.shumel@regeneron.com.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.06.054'] 693,32584199,Human and novel coronavirus infections in children: a review.,"Coronaviruses, seven of which are known to infect humans, can cause a spectrum of clinical presentations ranging from asymptomatic infection to severe illness and death. Four human coronaviruses (hCoVs)-229E, HKU1, NL63 and OC43-circulate globally, commonly infect children and typically cause mild upper respiratory tract infections. Three novel coronaviruses of zoonotic origin have emerged during the past two decades: severe acute respiratory syndrome coronavirus (SARS-CoV-1), Middle East respiratory syndrome coronavirus (MERS-CoV) and the recently discovered severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which is the cause of the ongoing coronavirus disease 2019 (COVID-19) pandemic. These novel coronaviruses are known to cause severe illness and death predominantly in older adults and those with underlying comorbidities. Consistent with what has been observed during the outbreaks of SARS and MERS, children with COVID-19 are more likely to be asymptomatic or to have mild-to-moderate illness, with few deaths reported in children globally thus far. Clinical symptoms and laboratory and radiological abnormalities in children have been similar to those reported in adults but are generally less severe. A rare multisystem inflammatory syndrome in children (MIS-C) which has resulted in critical illness and some deaths has recently been described. Clinical trials for therapeutics and vaccine development should include paediatric considerations. Children may play an important role in the transmission of infection and outbreak dynamics and could be a key target population for effective measures to control outbreaks. The unintended consequences of the unprecedented scale and duration of pandemic control measures for children and families around the world should be carefully examined. Abbreviations: 2019-nCoV, 2019 novel coronavirus; ADEM, acute demyelinating encephalomyelitis; AAP, American Academy of Pediatrics; ACE-2, angiotensin-converting enzyme 2; ARDS, acute respiratory distress syndrome; BCG, bacillus Calmette-Guérin; BNP, brain natriuretic peptide; CDC, Centers for Disease Control and Prevention; CRP, C-reactive protein; CSF, cerebrospinal fluid; COVID-19, coronavirus disease 2019; CT, computed tomography; CXR, chest X-ray; DOL, day of life; hCoV, human coronavirus; ICU, intensive care unit; IL, interleukin; IVIG, intravenous immunoglobulin; KD, Kawasaki disease; LDH, lactate dehydrogenase; MERS, Middle East respiratory syndrome; MERS-CoV, Middle East respiratory syndrome coronavirus; MEURI, monitored emergency use of unregistered and experimental interventions; MIS-C, multi-system inflammatory syndrome in children; PCR, polymerase chain reaction; PICU, paediatric intensive care unit; RNA, ribonucleic acid; RCT, randomised-controlled trial; RSV, respiratory syncytial virus; SARS, severe acute respiratory syndrome; SARS-CoV-1, severe acute respiratory syndrome coronavirus 1; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; TNF-alpha, tumour necrosis factor alpha; UK United Kingdom; UNICEF, United Nations Children's Fund; USA, United States of America; WHO, World Health Organization.",2021,"Three novel coronaviruses of zoonotic origin have emerged during the past two decades: severe acute respiratory syndrome coronavirus (SARS-CoV-1), Middle East respiratory syndrome coronavirus (MERS-CoV) and the recently discovered severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which is the cause of the ongoing coronavirus disease 2019 (COVID-19) pandemic.","['children (MIS-C', 'children and families', 'children']",[],['Clinical symptoms and laboratory and radiological abnormalities'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0015576', 'cui_str': 'Family'}]",[],"[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}]",,0.0673214,"Three novel coronaviruses of zoonotic origin have emerged during the past two decades: severe acute respiratory syndrome coronavirus (SARS-CoV-1), Middle East respiratory syndrome coronavirus (MERS-CoV) and the recently discovered severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which is the cause of the ongoing coronavirus disease 2019 (COVID-19) pandemic.","[{'ForeName': 'Nipunie', 'Initials': 'N', 'LastName': 'Rajapakse', 'Affiliation': 'Division of Pediatric Infectious Diseases, Department of Pediatric and Adolescent Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Devika', 'Initials': 'D', 'LastName': 'Dixit', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics and Internal Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.'}]",Paediatrics and international child health,['10.1080/20469047.2020.1781356'] 694,32584211,Predictors and moderators of treatment dropout in cognitive-behavioral and psychodynamic therapies for panic disorder.,"Introduction: Panic disorder patients who drop out of treatment typically do not remit from their disorder. How patient-level moderators influence dropping out of one panic-focused treatment over another has never been examined, nor in non-CBT treatments. Method: 200 patients with panic disorder with or without agoraphobia were randomized to receive cognitive-behavioral therapy (CBT), panic-focused psychodynamic psychotherapy (PFPP), or applied relaxation training (ART) across two sites. Therapy was twice a week for 12 weeks. A two-step variable search method was applied to identify potential prognostic predictors and moderators of patient dropout. Survival models predicting hazard of session-by-session dropout tested the resulting variables. Results: Across treatments, unemployment and higher psychosocial disability on the Sheehan Disability Scale predicted increased risk of dropout, while patients with higher anxiety sensitivity were more likely to complete treatment. Patients who reported experiencing childhood abuse had heightened dropout in ART, but not CBT or PFPP. Men were especially likely to complete PFPP. Session 2 expectancies and patient-rated alliance predicted lower dropout only in CBT. Conclusions: Patient-level factors may influence both whether patients will complete any treatment, and whether they continue in a particular panic-focused therapy. Moderators of dropout (e.g., abuse history) may inform treatment decisions for specific patients. Trial registration: ClinicalTrials.gov identifier: NCT00353470.",2021,"Across treatments, unemployment and higher psychosocial disability on the Sheehan Disability Scale predicted increased risk of dropout, while patients with higher anxiety sensitivity were more likely to complete treatment.","['panic disorder', '200 patients with panic disorder with or without agoraphobia', 'Patients who reported experiencing childhood abuse had heightened dropout in ART, but not CBT or PFPP', 'Panic disorder patients who drop out of treatment typically do not remit from their disorder']","['cognitive-behavioral therapy (CBT), panic-focused psychodynamic psychotherapy (PFPP), or applied relaxation training (ART', 'cognitive-behavioral and psychodynamic therapies']",['anxiety sensitivity'],"[{'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0442803', 'cui_str': 'Heightened'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C1261382', 'cui_str': 'Psychodynamic psychotherapy'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",200.0,0.0162106,"Across treatments, unemployment and higher psychosocial disability on the Sheehan Disability Scale predicted increased risk of dropout, while patients with higher anxiety sensitivity were more likely to complete treatment.","[{'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Keefe', 'Affiliation': 'Weill Medical College of Cornell University, New York, NY, USA.'}, {'ForeName': 'Dianne L', 'Initials': 'DL', 'LastName': 'Chambless', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Jacques P', 'Initials': 'JP', 'LastName': 'Barber', 'Affiliation': 'Adelphi University, Garden City, NY, USA.'}, {'ForeName': 'Barbara L', 'Initials': 'BL', 'LastName': 'Milrod', 'Affiliation': 'Weill Medical College of Cornell University, New York, NY, USA.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2020.1784487'] 695,32444220,A Phase II Randomized Clinical Trial of the Safety and Efficacy of Intravenous Umbilical Cord Blood Infusion for Treatment of Children with Autism Spectrum Disorder.,"OBJECTIVE To evaluate whether umbilical cord blood (CB) infusion is safe and associated with improved social and communication abilities in children with autism spectrum disorder (ASD). STUDY DESIGN This prospective, randomized, placebo-controlled, double-blind study included 180 children with ASD, aged 2-7 years, who received a single intravenous autologous (n = 56) or allogeneic (n = 63) CB infusion vs placebo (n = 61) and were evaluated at 6 months postinfusion. RESULTS CB infusion was safe and well tolerated. Analysis of the entire sample showed no evidence that CB was associated with improvements in the primary outcome, social communication (Vineland Adaptive Behavior Scales-3 [VABS-3] Socialization Domain), or the secondary outcomes, autism symptoms (Pervasive Developmental Disorder Behavior Inventory) and vocabulary (Expressive One-Word Picture Vocabulary Test). There was also no overall evidence of differential effects by type of CB infused. In a subanalysis of children without intellectual disability (ID), allogeneic, but not autologous, CB was associated with improvement in a larger percentage of children on the clinician-rated Clinical Global Impression-Improvement scale, but the OR for improvement was not significant. Children without ID treated with CB showed significant improvements in communication skills (VABS-3 Communication Domain), and exploratory measures including attention to toys and sustained attention (eye-tracking) and increased alpha and beta electroencephalographic power. CONCLUSIONS Overall, a single infusion of CB was not associated with improved socialization skills or reduced autism symptoms. More research is warranted to determine whether CB infusion is an effective treatment for some children with ASD.",2020,"Children without ID treated with CB showed significant improvements in communication skills (VABS-3 Communication Domain), and exploratory measures including attention to toys and sustained attention (eye-tracking) and increased alpha and beta electroencephalographic power. ","['Children with Autism Spectrum Disorder', 'children with ASD', 'children with autism spectrum disorder (ASD', '180 children with ASD, aged 2-7\xa0years, who received a single intravenous autologous (n\xa0=\xa056) or allogeneic (n\xa0=\xa063']","['CB', 'CB infusion vs placebo', 'Intravenous Umbilical Cord Blood Infusion', 'CB infusion', 'umbilical cord blood (CB) infusion', 'placebo']","['socialization skills or reduced autism symptoms', 'social communication (Vineland Adaptive Behavior Scales-3 [VABS-3] Socialization Domain), or the secondary outcomes, autism symptoms (Pervasive Developmental Disorder Behavior Inventory) and vocabulary (Expressive One-Word Picture Vocabulary Test', 'communication skills (VABS-3 Communication Domain), and exploratory measures including attention to toys and sustained attention (eye-tracking) and increased alpha and beta electroencephalographic power', 'safe and well tolerated']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}]","[{'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0037447', 'cui_str': 'Socialization'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0582680', 'cui_str': 'Vineland adaptive behavior scales'}, {'cui': 'C0077962', 'cui_str': 'VAB-III protocol'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0042927', 'cui_str': 'Vocabulary Tests'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040565', 'cui_str': 'Toy'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0330390', 'cui_str': 'Beta'}]",180.0,0.486169,"Children without ID treated with CB showed significant improvements in communication skills (VABS-3 Communication Domain), and exploratory measures including attention to toys and sustained attention (eye-tracking) and increased alpha and beta electroencephalographic power. ","[{'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Dawson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC; Marcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC. Electronic address: geraldine.dawson@duke.edu.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Sun', 'Affiliation': 'Marcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Baker', 'Affiliation': 'Marcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Compton', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Deaver', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Franz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Heilbron', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Brianna', 'Initials': 'B', 'LastName': 'Herold', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Horrigan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Howard', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Kosinski', 'Affiliation': 'Marcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Major', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Murias', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Page', 'Affiliation': 'Marcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Vinod K', 'Initials': 'VK', 'LastName': 'Prasad', 'Affiliation': 'Marcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Sabatos-DeVito', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Sanfilippo', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Linmarie', 'Initials': 'L', 'LastName': 'Sikich', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Simmons', 'Affiliation': 'Marcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Song', 'Affiliation': 'Marcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC; Duke Brain Imaging and Analysis Center, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Saritha', 'Initials': 'S', 'LastName': 'Vermeer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Waters-Pick', 'Affiliation': 'Marcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Troy', 'Affiliation': 'Marcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Kurtzberg', 'Affiliation': 'Marcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.03.011'] 696,32472263,"Functional outcome after corrective osteotomy for malunion of the distal radius: a randomised, controlled, double-blind trial.","PURPOSE The purpose of this randomised, controlled, double-blind trial was to evaluate functional outcome during the first year after corrective osteotomy for malunited distal radius fractures, with or without filling the osteotomy void. METHOD Patients were randomised to receive a HydroSet bone substitute or no graft. Cortical contact was maintained and stabilisation of the osteotomy was carried out with a DiPhos R- or RM Plate. To evaluate subjective functional outcome, the Patient-Rated Wrist Evaluation (PRWE), the Quick Disabilities of the Arm, Shoulder and Hand Questionnaire (Q-DASH), the Canadian Occupational Performance Measure (COPM) and the RAND-36 were used. Moreover, range of motion and grip strength were measured by blinded evaluators. Evaluations were made pre-operatively and three, six and 12 months post-operatively. RESULTS There were no significant differences between the groups at any time point post-operatively with respect to any of the PROMs that were used or range of motion or grip strength (p > 0.05). In both groups, there was a significant improvement at the 12-month follow-up compared with pre-operatively for the PRWE, the Q-DASH and the COPM satisfaction scores. The RAND-36 revealed no significant differences except for two domains, in which there was an improvement in the treatment group (p < 0.05). For grip strength and for range of motion in all movement directions, except dorsal extension, there was a significant improvement in both groups (p < 0.05). CONCLUSION There is no significant difference in functional outcome during the first year after corrective open-wedge distal radius osteotomy, where cortical contact is maintained, regardless of whether or not bone substitute to fill the void is used.",2020,There were no significant differences between the groups at any time point post-operatively with respect to any of the PROMs that were used or range of motion or grip strength (p > 0.05).,"['malunion of the distal radius', 'Patients']","['HydroSet bone substitute or no graft', 'corrective osteotomy']","['range of motion or grip strength', 'functional outcome', 'Patient-Rated Wrist Evaluation (PRWE), the Quick Disabilities of the Arm, Shoulder and Hand Questionnaire ', 'range of motion and grip strength', 'COPM satisfaction scores', 'Canadian Occupational Performance Measure (COPM']","[{'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0243003', 'cui_str': 'Bone Substitute'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}]","[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2585956', 'cui_str': 'Canadian occupational performance measure'}]",,0.070651,There were no significant differences between the groups at any time point post-operatively with respect to any of the PROMs that were used or range of motion or grip strength (p > 0.05).,"[{'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Andreasson', 'Affiliation': 'Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. Ingrid.f.andreasson@vgregion.se.'}, {'ForeName': 'Gunilla', 'Initials': 'G', 'LastName': 'Kjellby-Wendt', 'Affiliation': 'Department of Occupational Therapy and Physiotherapy, Sahlgrenska University Hospital, Mölndalsvägen 31, SE-431 80, Mölndal, Sweden.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Fagevik Olsén', 'Affiliation': 'Department of Occupational Therapy and Physiotherapy, Sahlgrenska University Hospital, Mölndalsvägen 31, SE-431 80, Mölndal, Sweden.'}, {'ForeName': 'Ylva', 'Initials': 'Y', 'LastName': 'Aurell', 'Affiliation': 'Department of Radiology, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ullman', 'Affiliation': 'Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Jón', 'Initials': 'J', 'LastName': 'Karlsson', 'Affiliation': 'Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",International orthopaedics,['10.1007/s00264-020-04605-x'] 697,32565318,Impact of Sequencing of Androgen Suppression and Radiation Therapy on Testosterone Recovery in Localized Prostate Cancer.,"PURPOSE We performed a secondary analysis of a phase 3 randomized trial to determine the influence of sequencing of radiation therapy and androgen deprivation therapy (ADT) on posttreatment testosterone recovery and implications of testosterone recovery on subsequent relapse. METHODS AND MATERIALS Patients with localized prostate cancer with Gleason score ≤7, clinical stage T1b to T3a, and prostate-specific antigen <30 ng/mL were randomized to neoadjuvant and concurrent ADT for 6 months starting 4 months before prostate radiation therapy (NHT arm) or concurrent and adjuvant ADT for 6 months starting simultaneously with radiation therapy (CAHT arm). Full testosterone recovery (FTR) was defined as recovery of testosterone to >10.5 nmol/L in patients with baseline ≥10.5 nmol/L or to baseline level in patients with baseline <10.5 nmol/L. Restricted mean survival time (RMST) since ADT initiation to supracastrate testosterone level (>1.7 nmol/L), and to FTR was compared between the arms using a truncation time point of 36 months. RESULTS The adjusted difference in RMST to supracastrate testosterone between the CAHT and NHT arm was 1.5 months (95% confidence interval [CI], 0.5-2.5; P = .005). No difference was noted in RMST to FTR between the arms (18.7 vs 18.5 months, adjusted difference: 0.5; 95% CI, -1.4 to 2.4; P = .61). There was no evidence of heterogeneity of treatment effect (interaction P = .76) on risk of relapse over subgroups stratified by testosterone recovery to supracastrate level at 15 months after start of ADT. Based on a multistate Markov model, no independent effect of time to FTR on risk of subsequent relapse was observed (adjusted hazard ratio: 1.02; 95% CI, 0.96-1.08). CONCLUSIONS Patients should be counseled that an additional 12 months on average is needed for FTR to occur after treatment with prostate radiation therapy and 6 months of ADT. This is independent of the sequencing of ADT and radiation therapy. Furthermore, recovery of testosterone does not appear to affect the risk of subsequent relapse.",2020,There was no evidence of heterogeneity of treatment effect (interaction p=0.76) on risk of relapse over subgroups stratified by testosterone recovery to supra-castrate level at 15 months after start of ADT.,"['Localized prostate cancer patients with Gleason', 'Localized Prostate Cancer']","['neoadjuvant and concurrent ADT', 'prostate radiotherapy (NHT arm) or concurrent and adjuvant ADT', 'Androgen Suppression and Radiotherapy', 'radiotherapy and ADT', 'prostate radiotherapy']","['RMST to FTR', 'mean survival time (RMST) since ADT initiation to supra-castrate testosterone level', 'RMST to supra-castrate testosterone', 'risk of subsequent relapse', 'risk of relapse', 'Full testosterone recovery (FTR', 'score ≤7, clinical stage T1b-T3a, and prostate-specific antigen', 'recovery of testosterone']","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0948317', 'cui_str': 'Radiotherapy to prostate'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0086595', 'cui_str': 'Mean Survival Time'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205563', 'cui_str': 'Clinical stage finding'}, {'cui': 'C0475385', 'cui_str': 'Tumor stage T1b'}, {'cui': 'C0475390', 'cui_str': 'Tumor stage T3a'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}]",,0.251948,There was no evidence of heterogeneity of treatment effect (interaction p=0.76) on risk of relapse over subgroups stratified by testosterone recovery to supra-castrate level at 15 months after start of ADT.,"[{'ForeName': 'Soumyajit', 'Initials': 'S', 'LastName': 'Roy', 'Affiliation': 'Radiation Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland; Division of Radiation Oncology, The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada; Department of Radiology, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Grimes', 'Affiliation': 'Division of Radiation Oncology, The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada.'}, {'ForeName': 'Libni', 'Initials': 'L', 'LastName': 'Eapen', 'Affiliation': 'Division of Radiation Oncology, The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada; Department of Radiology, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Spratt', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Malone', 'Affiliation': 'Division of Radiation Oncology, The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Craig', 'Affiliation': 'Division of Radiation Oncology, The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada.'}, {'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Morgan', 'Affiliation': 'Division of Radiation Oncology, The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada; Department of Radiology, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Malone', 'Affiliation': 'Division of Radiation Oncology, The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada; Department of Radiology, University of Ottawa, Ottawa, Ontario, Canada. Electronic address: smalone@toh.ca.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.06.017'] 698,32565319,Efficacy of Dose-Escalated Chemoradiation on Complete Tumor Response in Patients with Locally Advanced Rectal Cancer (RECTAL-BOOST): A Phase 2 Randomized Controlled Trial.,"PURPOSE Pathologic complete tumor response after chemoradiation in patients with locally advanced rectal cancer (LARC) is associated with a favorable prognosis and allows organ-sparing treatment strategies. In the RECTAL-BOOST trial, we aimed to investigate the effect of an external radiation boost to the tumor before chemoradiation on pathologic or sustained clinical complete tumor response in LARC. METHODS AND MATERIALS This multicenter, nonblinded, phase 2 randomized controlled trial followed the trials-within-cohorts design, which is a pragmatic trial design allowing cohort participants to be randomized for an experimental intervention. Patients in the intervention group are offered the intervention (and can either accept or refuse this), whereas patients in the control group are not notified about the randomization. Participants of a colorectal cancer cohort referred for chemoradiation of LARC to either of 2 radiation therapy centers were eligible. Patients were randomized to no boost or an external radiation boost (5 × 3 Gy) without concurrent chemotherapy, directly followed by standard pelvic chemoradiation (25 × 2 Gy with concurrent capecitabine). The primary outcome was pathologic complete response (ie, ypT0N0) in patients with planned surgery at 12 weeks, or, as surrogate for pathologic complete response, a 2-year sustained clinical complete response for patients treated with an organ preservation strategy. Analyses were intention to treat. The study was registered with ClinicalTrials.gov, number NCT01951521. RESULTS Between September 2014 and July 2018, 128 patients were randomized. Fifty-one of the 64 (79.7%) patients in the intervention group accepted and received a boost. Compared with the control group, fewer patients in the intervention group had a cT4 stage and a low rectal tumor (31.3% vs 17.2% and 56.3% vs 45.3%, respectively), and more patients had a cN2 stage (59.4% vs 70.3%, respectively). Rate of pathologic or sustained clinical complete tumor response was similar between the groups: 23 of 64 (35.9%; 95% confidence interval [CI], 24.3-48.9) in the intervention group versus 24 of 64 (37.5%; 95% CI, 25.7-50.5) in the control group (odds ratio [OR] = 0.94; 95% CI, 0.46-1.92). Near-complete or complete tumor regression was more common in the intervention group (34 of 49; 69.4%) than in the control group (24 of 53; 45.3%; (OR = 2.74, 95% CI 1.21-6.18). Grade ≥3 acute toxicity was comparable: 6 of 64 (9.4%) in the intervention group versus 5 of 64 (7.8%) in the control group (OR = 1.22; 95% CI, 0.35-4.22). CONCLUSIONS Dose escalation with an external radiation therapy boost to the tumor before neoadjuvant chemoradiation did not increase the pathologic or sustained clinical complete tumor response rate in LARC.",2020,"Compared with the control group, fewer patients in the intervention group had a cT4-stage and a low rectal tumour (31.3% versus 17.2% and 56.3% versus 45.3% respectively), and more patients had a cN2-stage (59.4% versus 70.3% respectively).","['patients with locally advanced rectal cancer (RECTAL-BOOST', 'Between Sept 2014 and July 2018, 128 patients were randomised', 'patients with locally advanced rectal cancer', 'Participants of a colorectal cancer cohort referred for chemoradiation of LARC to either of two radiotherapy centres were eligible']","['external radiation boost', 'external radiotherapy', 'external radiation boost (5 x 3 Gy) without concurrent chemotherapy directly followed by standard pelvic chemoradiation (25 x 2 Gy with concurrent capecitabine', 'dose-escalated chemoradiation']","['Rate of pathological or sustained clinical complete tumour response', 'pathological complete response (pCR, i.e. ypT0N0', 'cN2-stage', 'complete tumour response', 'cT4-stage and a low rectal tumour', 'Grade >3 acute toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C2919491', 'cui_str': 'Boost radiation therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",128.0,0.233842,"Compared with the control group, fewer patients in the intervention group had a cT4-stage and a low rectal tumour (31.3% versus 17.2% and 56.3% versus 45.3% respectively), and more patients had a cN2-stage (59.4% versus 70.3% respectively).","[{'ForeName': 'Alice M', 'Initials': 'AM', 'LastName': 'Couwenberg', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Utrecht, Utrecht, the Netherlands. Electronic address: A.M.Couwenberg@umcutrecht.nl.'}, {'ForeName': 'Johannes P M', 'Initials': 'JPM', 'LastName': 'Burbach', 'Affiliation': 'Department of Surgery, Medical Center Leeuwarden, the Netherlands.'}, {'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'Berbee', 'Affiliation': 'Department of Radiation Oncology (MAASTRO), GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Miangela M', 'Initials': 'MM', 'LastName': 'Lacle', 'Affiliation': 'Department of Pathology, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Arensman', 'Affiliation': 'Department of Pathology, Meander Medical Centre, Amersfoort, the Netherlands.'}, {'ForeName': 'Mihaela G', 'Initials': 'MG', 'LastName': 'Raicu', 'Affiliation': 'Department of Pathology, St. Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Frank J', 'Initials': 'FJ', 'LastName': 'Wessels', 'Affiliation': 'Department of Radiology, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Verdult', 'Affiliation': 'Department of Radiology, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'Roodhart', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Onne', 'Initials': 'O', 'LastName': 'Reerink', 'Affiliation': 'Department of Radiation Oncology, Insala Clinic, Zwolle, The Netherlands.'}, {'ForeName': 'Sieske', 'Initials': 'S', 'LastName': 'Hoendervangers', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Buijsen', 'Affiliation': 'Department of Radiation Oncology (MAASTRO), GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Heike I', 'Initials': 'HI', 'LastName': 'Grabsch', 'Affiliation': ""Department of Pathology, GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands; Pathology and Data Analytics, Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, United Kingdom.""}, {'ForeName': 'Apollo', 'Initials': 'A', 'LastName': 'Pronk', 'Affiliation': 'Department of Surgery, Diakonessenhuis, Utrecht, The Netherlands.'}, {'ForeName': 'Esther C J', 'Initials': 'ECJ', 'LastName': 'Consten', 'Affiliation': 'Department of Surgery, Meander Medical Center, Amersfoort, The Netherlands; Department of Surgery, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Anke B', 'Initials': 'AB', 'LastName': 'Smits', 'Affiliation': 'Department of Surgery, St. Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Joost T', 'Initials': 'JT', 'LastName': 'Heikens', 'Affiliation': 'Department of Surgery, Hospital Rievierenland, Tiel, The Netherlands.'}, {'ForeName': 'Ane L', 'Initials': 'AL', 'LastName': 'Appelt', 'Affiliation': ""Radiotherapy Research Group, Leeds Institute of Medicine at St James's, University of Leeds, Leeds, United Kingdom; Leeds Cancer Centre, St James University Hospital, Leeds, United Kingdom.""}, {'ForeName': 'Wilhelmina M U', 'Initials': 'WMU', 'LastName': 'van Grevenstein', 'Affiliation': 'Department of Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Helena M', 'Initials': 'HM', 'LastName': 'Verkooijen', 'Affiliation': 'Imaging Division, University Medical Center Utrecht, Utrecht, The Netherlands; Faculty of Medicine, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Martijn P W', 'Initials': 'MPW', 'LastName': 'Intven', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Utrecht, Utrecht, the Netherlands.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.06.013'] 699,32572490,Patient adherence with a smartphone app for patient-reported outcomes in rheumatoid arthritis.,"OBJECTIVES Electronic patient-reported outcomes (ePROs) transmitted digitally allow patients to communicate with their clinicians and track the activity of chronic diseases, such as RA. Several ePRO smartphone apps have been developed in rheumatology, yet few data have been reported regarding patient adherence. We developed a PRO app for RA and assessed adherence over 6 months. METHODS We developed an app to deliver daily assessments to participants (RA App v.1.0). The app was tested as part of a randomized controlled trial examining potential clinical benefits. The current analyses focus on the adherence to the ePRO app for patients randomized to receive the app. We recruited RA patients from an academic rheumatology practice in the USA. Patients randomized to receive the app received daily notifications regarding ePROs. We examined adherence to the PRO questionnaires over the 6-month study and examined factors related to adherence. RESULTS Seventy-eight patients received the app and have data included in these analyses: 63 (80.7%) were female, mean age was 55.2 years, 71% had attended college or beyond, and the mean Clinical Disease Activity Index at baseline was 9.7 (low disease activity). Median adherence to the daily questions was 79% (interquartile range 48-90%). Significant predictors of increased adherence were age ≥65 (P = 0.03) and low baseline Clinical Disease Activity Index (P = 0.02). CONCLUSION We developed and tested an ePRO app for RA over a 6-month study. Adherence to the app was strong. There was correlation between older age and better disease control and increased adherence. TRIAL REGISTRATION ClinicalTrials.gov, https://clinicaltrials.gov/, NCT02822521.",2021,"Significant predictors of increased adherence were age ≥65 (P = 0.03) and low baseline Clinical Disease Activity Index (P = 0.02). ","['RA patients from an academic rheumatology practice in the USA', 'Seventy-eight patients received the app and have data included in these analyses: 63 (80.7%) were female, mean age was 55.2\u2009years, 71% had attended college or beyond, and the mean Clinical Disease Activity Index at baseline was 9.7 (low disease activity']",['daily notifications regarding ePROs'],"['low baseline Clinical Disease Activity Index', 'Median adherence', 'PRO questionnaires']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0422202', 'cui_str': 'Notifications'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.175824,"Significant predictors of increased adherence were age ≥65 (P = 0.03) and low baseline Clinical Disease Activity Index (P = 0.02). ","[{'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Colls', 'Affiliation': ""Division of Rheumatology, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Yvonne C', 'Initials': 'YC', 'LastName': 'Lee', 'Affiliation': 'Division of Rheumatology, Northwestern University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': ""Division of Rheumatology, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Corrigan', 'Affiliation': ""Division of Rheumatology, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Fengxin', 'Initials': 'F', 'LastName': 'Lu', 'Affiliation': ""Division of Rheumatology, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Marquez-Grap', 'Affiliation': ""Division of Rheumatology, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Murray', 'Affiliation': ""Division of Rheumatology, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Dong H', 'Initials': 'DH', 'LastName': 'Suh', 'Affiliation': ""Division of Rheumatology, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Solomon', 'Affiliation': ""Division of Rheumatology, Brigham and Women's Hospital, Boston, MA.""}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa202'] 700,32497304,Changes in knee adduction moment wearing a variable-stiffness shoe correlate with changes in pain and mechanically stimulated cartilage oligomeric matrix levels.,"This study aimed to determine if changes in knee adduction moment (KAM) after 6 months of variable-stiffness shoe wear are associated with changes in symptoms or serum levels of cartilage oligomeric matrix protein (COMP) following a mechanical stimulus in subjects with medial knee osteoarthritis (OA). Twenty-five subjects were enrolled in the study and assigned a variable-stiffness shoe, and 19 subjects completed the 6-month follow-up. At baseline and follow-up subjects underwent gait analysis in control and variable-stiffness shoes, completed Western Ontario and McMaster Universities (WOMAC) questionnaires, and serum COMP concentrations were measured immediately before, 3.5 and 5.5 hours after a 30-minute walking activity. Relationships between changes in KAM (first peak and impulse) and changes in (a) COMP levels in response to the 30-minute walking activity and (b) WOMAC scores from baseline to 6-month follow-up were assessed by Pearson correlation coefficients. Changes in first peak KAM were associated with changes in COMP levels 5.5 hours postactivity from baseline to follow-up (R = .564, P = .045). Subjects with greater reductions in KAM had larger decreases in COMP (expressed as a percent of preactivity levels) at follow-up. Subjects with greater reductions in KAM impulse had significantly greater improvements in WOMAC Pain (R = -.56, P = .015) and Function (R = -.52, P = .028) scores at follow-up. The study results demonstrated the magnitude of reduction in the KAM wearing a variable-stiffness shoe is associated with decreases in mechanically stimulated COMP levels and pain/function. This work suggests that interactions between COMP and joint loading during walking should be further investigated in future studies of treatment outcomes in OA.",2021,"Subjects with greater reductions in KAM impulse had significantly greater improvements in WOMAC Pain (R = -.56, P = .015) and Function (R = -.52, P = .028) scores at follow-up.","['Twenty-five subjects were enrolled in the study and assigned a variable-stiffness shoe, and 19 subjects completed the 6-month follow-up', 'subjects with medial knee osteoarthritis (OA']",['KAM'],"['COMP levels', 'COMP', 'knee adduction moment (KAM', 'KAM (first peak and impulse) and changes in (a) COMP levels in response to the 30-minute walking activity and (b) WOMAC scores', 'Western Ontario and McMaster Universities (WOMAC) questionnaires, and serum COMP concentrations', 'WOMAC Pain']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0036988', 'cui_str': 'Shoes'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231457', 'cui_str': 'Adduction'}]","[{'cui': 'C0601900', 'cui_str': 'COMP (Cartilage Oligomeric Matrix Protein)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231457', 'cui_str': 'Adduction'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",25.0,0.0232041,"Subjects with greater reductions in KAM impulse had significantly greater improvements in WOMAC Pain (R = -.56, P = .015) and Function (R = -.52, P = .028) scores at follow-up.","[{'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Erhart-Hledik', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University, Stanford, California.'}, {'ForeName': 'Gordhan B', 'Initials': 'GB', 'LastName': 'Mahtani', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University, Stanford, California.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Asay', 'Affiliation': 'VA Palo Alto Health Care System, Palo Alto, California.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Migliore', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University, Stanford, California.'}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Nguyen', 'Affiliation': 'VA Palo Alto Health Care System, Palo Alto, California.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Andriacchi', 'Affiliation': 'VA Palo Alto Health Care System, Palo Alto, California.'}, {'ForeName': 'Constance R', 'Initials': 'CR', 'LastName': 'Chu', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University, Stanford, California.'}]",Journal of orthopaedic research : official publication of the Orthopaedic Research Society,['10.1002/jor.24770'] 701,32574009,"A Double-Blind, Comparative Clinical Study of Newly Formulated Retinol Serums vs Tretinoin Cream in Escalating Doses: A Method for Rapid Retinization With Minimized Irritation.","OBJECTIVE The goal of this 12 week, double-blinded, controlled, clinical study was to compare the efficacy, tolerability, and consumer acceptance of three novel retinol serums to tretinoin. METHOD Forty-five photoaged females ages 35-65, Fitzpatrick skin types I-IV, with moderate wrinkling were enrolled in the 12-week study. A step-up protocol for increasing the dose of retinol serum (0.25%, 0.5%, 1.0%) or tretinoin cream (0.025%, 0.05%, and 0.1%) in combination with a test moisturizer or currently marketed dermatologist-recommended moisturizing cream was used. Overall severity of investigator graded photodamage, subject assessed photodamage, and tolerability criteria were evaluated using a 5-point ordinal scale at weeks 4, 8, and 12. Facial photography occurred at each visit and TEWL was measured at baseline and week 12. Histologic evaluation of punch biopsies was completed on baseline and week 12 samples. RESULTS After 12 weeks of use, both retinol serum and tretinoin demonstrated parity across investigator and subject assessment measurements as well as diagnostic measures including TEWL. Retinol serum subjects showed significant week 4 improvement in visual skin smoothness compared to tretinoin subjects (P=0.031). There was highly significant improvement in skin dryness with the retinol serum (P<0.001) not seen in the tretinoin group. Histologic analysis of baseline and 12-week punch biopsies demonstrated newly formed collagen and greater epidermal thickening in retinol serum subjects compared to tretinoin treated subjects. CONCLUSION Retinol serum (0.25%, 0.5%, 1.0%) was safe and effective with equivalent/or better performance and tolerability than tretinoin creams. J Drugs Dermatol. 2020;19(6): doi:10.36849/JDD.2020.5085.",2020,There was highly significant improvement in skin dryness with the retinol serum (P<0.001) not seen in the tretinoin group.,"['Escalating Doses', 'Forty-five photoaged females ages 35-65, Fitzpatrick skin types I-IV, with moderate wrinkling were enrolled in the 12-week study']","['tretinoin', 'tretinoin cream', 'retinol serum and tretinoin', 'Newly Formulated Retinol Serums vs Tretinoin Cream']","['Overall severity of investigator graded photodamage, subject assessed photodamage, and tolerability criteria', 'retinol serum', 'diagnostic measures including TEWL', 'Histologic evaluation of punch biopsies', 'efficacy, tolerability, and consumer acceptance', 'Retinol serum', 'visual skin smoothness', 'skin dryness', 'Facial photography', 'safe and effective with equivalent/or better performance and tolerability']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C1252062', 'cui_str': 'Tretinoin Topical Cream'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0184924', 'cui_str': 'Punch biopsy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0151908', 'cui_str': 'Dry skin'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",,0.0450016,There was highly significant improvement in skin dryness with the retinol serum (P<0.001) not seen in the tretinoin group.,"[{'ForeName': 'Zoe Diana', 'Initials': 'ZD', 'LastName': 'Draelos', 'Affiliation': ''}, {'ForeName': 'R Scott', 'Initials': 'RS', 'LastName': 'Peterson', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.2020.10.36849/JDD.2020.5085'] 702,32574011,New Polymeric Once-Daily Tazarotene 0.045% Lotion Formulation for Moderate-to-Severe Acne: Pooled Phase 3 Pediatric Analysis.,"BACKGROUND Acne vulgaris affects approximately 85% of adolescents. Topical tazarotene is efficacious and safe for acne treatment but irritation limits its use. The objective was to evaluate efficacy, safety, and tolerability of a new tazarotene 0.045% lotion formulation in patients aged 10-13 and 14-17 years with moderate-to-severe acne. METHODS In two phase 3, double-blind, vehicle-controlled 12-week studies, patients with moderate-to-severe acne (N=1,614) were randomized (1:1) to receive tazarotene 0.045% lotion or vehicle once-daily. Efficacy assessments included changes from baseline in inflammatory/noninflammatory lesions and treatment success (≥2-grade reduction in Evaluator's Global Severity Score [EGSS] and a clear/almost clear score). Quality of life (QoL) and adverse events (AEs) were also assessed. RESULTS Patients aged 10-13 years (n=136) and 14-17 years (n=548) were pooled. At week 12, mean percent reductions in inflammatory and noninflammatory lesion counts were significantly greater with tazarotene versus vehicle in both age groups (least-squares mean inflammatory 10-13 years: -55.6 vs -37.0%; 14-17 years: -53.3 vs -41.2%; noninflammatory 10-13 years: -47.7 vs -28.2%; 14-17 years: -52.7 vs -32.9%; P<0.01 all). More patients achieved treatment success with tazarotene versus vehicle in both age groups (P<0.05, both). There were no significant differences between tazarotene-treated age groups in lesion counts or treatment success. Acne-QoL scores at week 12 in both age groups were numerically improved in most domains with tazarotene 0.045% lotion versus vehicle. Most treatment-emergent AEs with tazarotene or vehicle were of mild or moderate severity in both age groups. CONCLUSIONS Tazarotene 0.045% lotion was efficacious and well tolerated in pediatric patients with moderate-to-severe acne. J Drugs Dermatol. 2020;19(6): doi:10.36849/JDD.2020.4959.",2020,Acne-QoL scores at week 12 in both age groups were numerically improved in most domains with tazarotene 0.045% lotion versus vehicle.,"['Moderate-to-Severe Acne', 'patients aged 10-13 and 14-17 years with moderate-to-severe acne', 'Patients aged 10-13 years (n=136) and 14-17 years (n=548) were pooled', 'patients with moderate-to-severe acne (N=1,614', 'pediatric patients with moderate-to-severe acne']","['New Polymeric Once-Daily Tazarotene 0.045% Lotion Formulation', 'tazarotene 0.045% lotion formulation', 'tazarotene 0.045% lotion or vehicle once-daily', 'Topical tazarotene', 'tazarotene', 'Tazarotene 0.045% lotion']","['efficacious and well tolerated', 'efficacy, safety, and tolerability', ""inflammatory/noninflammatory lesions and treatment success (≥2-grade reduction in Evaluator's Global Severity Score [EGSS] and a clear/almost clear score"", 'inflammatory and noninflammatory lesion counts', 'Acne-QoL scores', 'lesion counts or treatment success', 'Quality of life (QoL) and adverse events (AEs']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0288792', 'cui_str': 'tazarotene'}, {'cui': 'C4517410', 'cui_str': '0.045'}, {'cui': 'C0544341', 'cui_str': 'Lotion'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C3215236', 'cui_str': 'Tazarotene-containing product in cutaneous dose form'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442743', 'cui_str': 'Noninflammatory'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1614.0,0.0993488,Acne-QoL scores at week 12 in both age groups were numerically improved in most domains with tazarotene 0.045% lotion versus vehicle.,"[{'ForeName': 'Lawrence F', 'Initials': 'LF', 'LastName': 'Eichenfield', 'Affiliation': ''}, {'ForeName': 'Emil A', 'Initials': 'EA', 'LastName': 'Tanghetti', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Guenin', 'Affiliation': ''}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'Radhakrishnan', 'Initials': 'R', 'LastName': 'Pillai', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.2020.10.36849/JDD.2020.4959'] 703,32576042,SHORT-TERM VERSUS 6-WEEK PREDNISONE IN THE TREATMENT OF SUBACUTE THYROIDITIS: A RANDOMIZED CONTROLLED TRIAL.,"Objective : Moderate-to-severe subacute thyroiditis is clinically managed with 6-8 weeks of glucocorticoid therapy. However, no studies have evaluated short-term prednisone treatment for subacute thyroiditis. Methods : This 24-week, prospective, single-blind, randomized controlled study enrolled patients (aged 18-70) with subacute thyroiditis who were hospitalized between August 2013 and December 2014. Patients with moderate-to-severe symptoms were randomly assigned to receive either 30 mg/d prednisone for 1 week, followed by 1 week of nonsteroidal anti-inflammatory drugs, or the conventional 6-week prednisone therapy. The primary endpoint was intergroup differences in treatment efficacy at the end of treatment course. Secondary endpoints included between-group differences in post-withdrawal adverse effect parameters and thyroid function at weeks 6, 12, and 24. Results : We screened 96 patients, randomized 52 participants, and 50 completed the study. Efficacy and recurrence rates were not significantly different at withdrawal in both groups ( P=0.65 ). At treatment discontinuation, parathyroid hormone (28.8 vs 38.9 pg/mL, p=0.011 ) and systolic blood pressure (113.9 vs 122.4 mmHg, p=0.023 ) were significantly lower in the experimental group than in the control group. There were no significant intergroup differences in other secondary endpoints at withdrawal and in thyroid function at weeks 6, 12, and 24. Conclusions : Fewer side effects of glucocorticoids and similar efficacy and recurrence rates were observed with short-term prednisone compared with in the 6-week treatment for subacute thyroiditis. Short-term prednisone with a better safety profile may be an alternative strategy for ameliorating moderate-to-severe symptoms of subacute thyroiditis.",2020,"There were no significant intergroup differences in other secondary endpoints at withdrawal and in thyroid function at weeks 6, 12, and 24. ","['Patients with moderate-to-severe symptoms', '96 patients, randomized 52 participants, and 50 completed the study', 'enrolled patients (aged 18-70) with subacute thyroiditis who were hospitalized between August 2013 and December 2014']","['30 mg/d prednisone', 'prednisone', 'nonsteroidal anti-inflammatory drugs, or the conventional 6-week prednisone therapy', 'glucocorticoid therapy', 'glucocorticoids']","['Efficacy and recurrence rates', 'treatment efficacy', 'post-withdrawal adverse effect parameters and thyroid function', 'systolic blood pressure', 'efficacy and recurrence rates', 'parathyroid hormone']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0040149', 'cui_str': 'Subacute thyroiditis'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]","[{'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0744425', 'cui_str': 'Glucocorticoid therapy'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}]",52.0,0.0775229,"There were no significant intergroup differences in other secondary endpoints at withdrawal and in thyroid function at weeks 6, 12, and 24. ","[{'ForeName': 'Lian', 'Initials': 'L', 'LastName': 'Duan', 'Affiliation': 'From: Department of Endocrinology, The Third Affiliated Hospital of Chongqing Medical University (Jie er Hospital), Chongqing, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Xiaojuan', 'Initials': 'X', 'LastName': 'Tan', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Xiang', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Rufei', 'Initials': 'R', 'LastName': 'Shen', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Hongting', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Third Military Medical University, Chongqing, China.'}]",Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists,['10.4158/EP-2020-0096'] 704,32443179,A polling experiment on public opinion on the future expansion of Medicare and Medicaid.,"OBJECTIVE To conduct a polling experiment to understand the possible framing effects that drive constituents' views around Medicare For All (MFA) and Medicaid Buy-In (MBI). DATA SOURCES AND STUDY SETTING Five thousand and fifty-one US adults aged 18 and older were recruited to participate in an online poll conducted between September 12, 2018, and September 26, 2018. STUDY DESIGN Participants were randomized to receive one of four polls: (a) a poll measuring respondent approval for MFA, with the name of the proposal stated with a description; (b) a poll measuring approval for MFA, with only a description of the proposal; (c) a poll measuring approval for MBI, with the name stated with a description; or (d) a poll measuring approval for MBI, with only a description. PRINCIPAL FINDINGS Including the names ""Medicare For All"" and ""Medicaid Buy-In"" increases approval by 3.4 (from 32.7 percent to 36.1 percent) and 5.0 (from 50.1 percent to 55.1 percent) percentage points, respectively. Support varies by age, where MBI is most strongly supported by Millennials, while Baby Boomers and those older than 65 are more likely to support MFA. CONCLUSIONS Constituents are more likely to support a proposal when given the names of the proposal. Approval is also higher for health policies that are framed as expansions of existing policies than as new programs.",2020,"Support varies by age, where MBI is most strongly supported by Millennials, while Baby Boomers and those older than 65 are more likely to support MFA. ","['Participants', 'Five thousand and fifty-one US adults aged 18 and older were recruited to participate in an online poll conducted between September 12, 2018, and September 26, 2018']","['poll measuring respondent approval for MFA, with the name of the proposal stated with a description; (b) a poll measuring approval for MFA, with only a description of the proposal; (c) a poll measuring approval for MBI, with the name stated with a description; or (d) a poll measuring approval for MBI, with only a description']",[],"[{'cui': 'C4319610', 'cui_str': '5000'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}]",[],5051.0,0.0357672,"Support varies by age, where MBI is most strongly supported by Millennials, while Baby Boomers and those older than 65 are more likely to support MFA. ","[{'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Karra', 'Affiliation': 'Frederick S. Pardee School of Global Studies, Boston University, Boston, Massachusetts, USA.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Sandoe', 'Affiliation': 'Graduate School of Arts and Sciences, Harvard University, Cambridge, Massachusetts, USA.'}]",Health services research,['10.1111/1475-6773.13295'] 705,32444980,Randomized prospective trial of fractionated stereotactic radiosurgery with chemotherapy versus chemotherapy alone for bevacizumab-resistant high-grade glioma.,"PURPOSE Outcomes for patients with recurrent high-grade glioma (HGG) progressing on bevacizumab (BEV) are dismal. Fractionated stereotactic radiosurgery (FSRS) has been shown to be feasible and safe when delivered in this setting, but prospective evidence is lacking. This single-institution randomized trial compared FSRS plus BEV-based chemotherapy versus BEV-based chemotherapy alone for BEV-resistant recurrent malignant glioma. MATERIALS AND METHODS HGG patients on BEV with tumor progression after 2 previous treatments were randomized to 1) FSRS plus BEV-based chemotherapy or 2) BEV-based chemotherapy with irinotecan, etoposide, temozolomide, or carboplatin. FSRS was delivered as 32 Gy (8 Gy × 4 fractions within 2 weeks) to the gross target volume and 24 Gy (6 Gy × 4 fractions) to the clinical target volume (fluid-attenuated inversion recovery abnormality). The primary endpoints were local control (LC) at 2 months and progression-free survival (PFS). RESULTS Of the 35 patients enrolled, 29 had glioblastoma (WHO IV) and 6 had anaplastic glioma (WHO III). The median number of prior recurrences was 3. Patients treated with FSRS had significantly improved PFS (5.1 vs 1.8 months, P < .001) and improved LC at 2 months (82% [14/17] vs 27% [4/15], P = .002). The overall median survival was 6.6 months (7.2 months with FSRS vs 4.8 months with chemotherapy alone, P = .11). CONCLUSIONS FSRS combined with BEV-based chemotherapy in recurrent HGG patients progressing on BEV is feasible and improves LC and PFS when compared to treatment with BEV-based chemotherapy alone.",2020,"Patients treated with FSRS had significantly improved PFS (5.1 vs 1.8 months, P < .001) and improved LC at 2 months (82% [14/17] vs 27% [4/15], P = .002).","['6 had anaplastic glioma (WHO III', '35 patients enrolled, 29 had glioblastoma (WHO IV) and', 'HGG patients on BEV with tumor progression after 2 previous treatments', 'resistant high-grade glioma', 'patients with recurrent high-grade glioma (HGG) progressing on']","['Fractionated stereotactic radiosurgery (FSRS', 'FSRS plus BEV-based chemotherapy or 2) BEV-based chemotherapy with irinotecan, etoposide, temozolomide, or carboplatin', 'bevacizumab (BEV', 'fractionated stereotactic radiosurgery with chemotherapy versus chemotherapy', 'FSRS combined with BEV-based chemotherapy', 'FSRS plus BEV-based chemotherapy versus BEV-based chemotherapy alone', 'FSRS', 'bevacizumab']","['median number of prior recurrences', 'local control (LC) at 2\xa0months and progression-free survival (PFS', 'PFS', 'overall median survival']","[{'cui': 'C0205618', 'cui_str': 'Undifferentiated'}, {'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0555198', 'cui_str': 'Glioma, malignant, no ICD-O subtype'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0178874', 'cui_str': 'Tumor progression'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0085203', 'cui_str': 'Radiosurgery'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",35.0,0.0793639,"Patients treated with FSRS had significantly improved PFS (5.1 vs 1.8 months, P < .001) and improved LC at 2 months (82% [14/17] vs 27% [4/15], P = .002).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bergman', 'Affiliation': 'Department of Radiation Oncology, Henry Ford Health System, 2799 W Grand Blvd, Detroit, MI, 48202, USA.'}, {'ForeName': 'Ankit', 'Initials': 'A', 'LastName': 'Modh', 'Affiliation': 'Department of Radiation Oncology, Henry Ford Health System, 2799 W Grand Blvd, Detroit, MI, 48202, USA.'}, {'ForeName': 'Lonni', 'Initials': 'L', 'LastName': 'Schultz', 'Affiliation': 'Department of Neurosurgery, Henry Ford Health System, 2799 W Grand Blvd, Detroit, MI, 48202, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Snyder', 'Affiliation': 'Department of Neurosurgery, Henry Ford Health System, 2799 W Grand Blvd, Detroit, MI, 48202, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Mikkelsen', 'Affiliation': 'Department of Neurosurgery, Henry Ford Health System, 2799 W Grand Blvd, Detroit, MI, 48202, USA.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Shah', 'Affiliation': 'Department of Radiation Oncology, Henry Ford Health System, 2799 W Grand Blvd, Detroit, MI, 48202, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Ryu', 'Affiliation': 'Department of Radiation Oncology, Stony Brook University Hospital, 101 Nicolls Road, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'M Salim', 'Initials': 'MS', 'LastName': 'Siddiqui', 'Affiliation': 'Department of Radiation Oncology, Henry Ford Health System, 2799 W Grand Blvd, Detroit, MI, 48202, USA.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Walbert', 'Affiliation': 'Department of Neurosurgery, Henry Ford Health System, 2799 W Grand Blvd, Detroit, MI, 48202, USA. twalber1@hfhs.org.'}]",Journal of neuro-oncology,['10.1007/s11060-020-03526-4'] 706,32446951,Dexamethasone for the Prevention of a Pain Flare After Palliative Radiation Therapy for Painful Bone Metastases: The Multicenter Double-Blind Placebo-Controlled 3-Armed Randomized Dutch DEXA Study.,"PURPOSE After radiation therapy for painful bone metastases, up to 44% of patients report a pain flare (PF). Our study compared 2 dose schedules of dexamethasone versus placebo to prevent PF. METHODS AND MATERIALS This double-blind, randomized, placebo-controlled trial allocated patients with painful bone metastases from solid tumors randomly to receive 8 mg dexamethasone before radiation therapy followed by 3 daily doses (group A), 8 mg dexamethasone followed by 3 doses of placebo (group B), or 4 doses of placebo (group C). Patients reported worst pain scores, study medication side effects, and opioid intake before treatment and thereafter daily for 14 days and on day 28. PF was defined as at least a 2-point increase on a 0 to 10 pain scale with no decrease in opioid intake or a 25% or greater increase in opioid intake with no decrease in pain score, followed by a return to baseline or lower. The primary analysis was by intention to treat with patients who had missing data classified as having a PF. RESULTS From January 2012 to April 2016, 295 patients were randomized. PF incidence was 38% for group A, 27% for group B, and 39% for group C (P = .07). Although patients in group B had the lowest PF incidence, a relatively high percentage did not return to baseline pain levels, indicating pain progression. The mean duration of PF was 2.1 days for group A, 4.5 days for group B, and 3.3 days for group C (P = .0567). Dexamethasone postponed PF occurrence; in group A 52% occurred on days 2 to 5 versus 73% in group B and 99% in group C (P = .02). Patients in group A reported lower mean pain scores on days 2 to 5 than those in group B or C (P < .001). Side effects were similar. CONCLUSIONS There was insufficient evidence that dexamethasone reduced the incidence of radiation-induced PF. However, dexamethasone postponed the occurrence of PF and led to lower mean pain scores on days 2 to 5.",2020,Patients in group A reported lower mean pain scores on days 2-5 than in B or C (p<0.001).,"['patients with painful bone metastases from solid tumors randomly to receive A: 8 mg', 'painful bone metastases', 'From January 2012 to April 2016, 295 patients were randomized', 'painful bone metastases up to 44% of patients report a pain flare (PF']","['radiotherapy', 'dexamethasone', 'dexamethasone before radiotherapy', 'Dexamethasone', 'palliative radiotherapy', 'placebo']","['mean duration of PF', 'PF incidence', 'incidence of radiation-induced PF', 'Side effects', 'mean pain scores', 'opioid intake', 'PF', 'pain score', 'worst pain scores, study medication side effects and opioid intake', 'PF occurrence', 'lowest PF-incidence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0153690', 'cui_str': 'Secondary malignant neoplasm of bone'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",295.0,0.596742,Patients in group A reported lower mean pain scores on days 2-5 than in B or C (p<0.001).,"[{'ForeName': 'Yvette M', 'Initials': 'YM', 'LastName': 'van der Linden', 'Affiliation': 'Department of Radiotherapy, Leiden University Medical Centre, Leiden, the Netherlands; Centre of Expertise in Palliative Care, Leiden University Medical Centre, Leiden, the Netherlands. Electronic address: ymvanderlinden@lumc.nl.'}, {'ForeName': 'Paulien G', 'Initials': 'PG', 'LastName': 'Westhoff', 'Affiliation': 'Department of Radiotherapy, University Medical Centre Utrecht, Utrecht, the Netherlands; Department of Radiotherapy, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Stellato', 'Affiliation': 'Department of Biostatistics, Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'van Baardwijk', 'Affiliation': 'MAASTRO, Maastricht, the Netherlands.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'de Vries', 'Affiliation': 'Department of Radiotherapy, National Cancer Institute, Amsterdam, the Netherlands; Department of Radiotherapy, Erasmus Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Ong', 'Affiliation': 'Department of Radiotherapy, Medical Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Ruud', 'Initials': 'R', 'LastName': 'Wiggenraad', 'Affiliation': 'Department of Radiotherapy, Haaglanden Medical Centre, The Hague, the Netherlands.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Bakri', 'Affiliation': 'Department of Radiotherapy, Reinier de Graaf Hospital, Delft, the Netherlands.'}, {'ForeName': 'Gerda', 'Initials': 'G', 'LastName': 'Wester', 'Affiliation': 'Radiotherapy Group Arnhem, Arnhem, the Netherlands.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'de Pree', 'Affiliation': 'Department of Radiotherapy, Erasmus Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Lieneke', 'Initials': 'L', 'LastName': 'van Veelen', 'Affiliation': 'ZRTI, Vlissingen, the Netherlands.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Budiharto', 'Affiliation': 'Department of Radiotherapy, Catharina Hospital, Eindhoven, the Netherlands.'}, {'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'Schippers', 'Affiliation': 'Bernard Verbeeten Institute, Tilburg, the Netherlands.'}, {'ForeName': 'Anna K L', 'Initials': 'AKL', 'LastName': 'Reyners', 'Affiliation': 'Department of Medical Oncology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'de Graeff', 'Affiliation': 'Department of Medical Oncology, University Medical Centre Utrecht, Utrecht, the Netherlands.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.05.007'] 707,32447767,"Efficacy and safety of Jessner's solution peel in comparison with salicylic acid 30% peel in the management of patients with acne vulgaris and postacne hyperpigmentation with skin of color: a randomized, double-blinded, split-face, controlled trial.","OBJECTIVE Antibiotics and retinoids have been used for acne vulgaris for decades. Though effective, each has its own drawbacks. Chemical peels have been used for treatment of acne vulgaris with inadequate clinical evidence. We sought to determine the efficacy and safety of Jessner's solution (JS) in comparison with salicylic acid (SA) 30% in the management of acne vulgaris and postacne hyperpigmentation in patients with colored skin. METHODS A total of 36 subjects (94.5% Fitzpatick Type IV-V) were recruited in this randomized double-blinded, split-face, controlled trial. Each side of the face was randomly assigned for treatment with either JS or SA. Subjects were treated once fortnightly for a total of three sessions. Lesion counting, Michaelsson acne score (MAS), photographs, and postacne hyperpigmentation index (PAHPI) were used to objectively assess the improvement. Complications were assessed during each visit. Statistical analysis was conducted using SPSS v22.0. Significance was set at P = 0.05. RESULTS At the end of therapy, significant reduction in inflammatory, noninflammatory lesions, MAS, and PAHPI scores (P < 0.001, respectively) were noted in comparison to baseline. Mixed model analysis revealed no significant outcome difference between the two groups. Patients who reported good and very good outcome were 76.4% (JS) and 85.3% (SA). Burning, stinging sensation, and exfoliation were the common complications reported. Postinflammatory hyperpigmentation was reported only once in the JS arm. CONCLUSION Both JS and SA were equally effective in the treatment of acne vulgaris and reducing postacne hyperpigmentation in patients with colored skin.",2020,Both JS and SA were equally effective in the treatment of acne vulgaris and reducing postacne hyperpigmentation in patients with colored skin.,"['patients with colored skin', 'patients with acne vulgaris and postacne hyperpigmentation with skin of color', '36 subjects (94.5% Fitzpatick Type IV-V']","['salicylic acid (SA', ""Jessner's solution (JS"", 'JS or SA', ""Jessner's solution peel"", 'salicylic acid 30% peel']","['Burning, stinging sensation, and exfoliation', 'Lesion counting, Michaelsson acne score (MAS), photographs, and postacne hyperpigmentation index (PAHPI', 'postacne hyperpigmentation', 'Complications', 'inflammatory, noninflammatory lesions, MAS, and PAHPI scores', 'Postinflammatory hyperpigmentation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0441732', 'cui_str': 'Type 4'}]","[{'cui': 'C0036079', 'cui_str': 'Salicylic Acid'}, {'cui': 'C0064150', 'cui_str': ""Jessner's solution""}, {'cui': 'C0237849', 'cui_str': 'Peeling of skin'}]","[{'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0677500', 'cui_str': 'Stinging'}, {'cui': 'C0040439', 'cui_str': 'Exfoliation of teeth'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0442743', 'cui_str': 'Noninflammatory'}, {'cui': 'C0333616', 'cui_str': 'Postinflammatory hyperpigmentation'}]",36.0,0.238022,Both JS and SA were equally effective in the treatment of acne vulgaris and reducing postacne hyperpigmentation in patients with colored skin.,"[{'ForeName': 'Kang N', 'Initials': 'KN', 'LastName': 'How', 'Affiliation': 'Dermatology Unit, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'Poh Y', 'Initials': 'PY', 'LastName': 'Lim', 'Affiliation': 'Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra, Serdang, Malaysia.'}, {'ForeName': 'Wan Syazween Lyana', 'Initials': 'WSL', 'LastName': 'Wan Ahmad Kammal', 'Affiliation': 'Dermatology Unit, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'Norashikin', 'Initials': 'N', 'LastName': 'Shamsudin', 'Affiliation': 'Dermatology Unit, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}]",International journal of dermatology,['10.1111/ijd.14948'] 708,32454259,An Unsuccessful Randomized Trial of Percutaneous vs Endoscopic Drainage of Suspected Malignant Hilar Obstruction.,"Percutaneous transhepatic biliary drainage (PTBD) and endoscopic retrograde cholangiopancreatography (ERCP) are widely accepted but competing approaches for the management of malignant obstruction at the hilum of the liver. ERCP is favored in the United States on the basis of high success rates for non-hilar indications, the perceived safety and superior tissue sampling capability of ERCP relative to PTBD, and the avoidance of external drains that are undesirable to patients. A recent randomized controlled trial (RCT) comparing the 2 modalities in patients with resectable hilar cholangiocarcinoma was terminated prematurely because of higher mortality in the PTBD group. 1 In contrast, most observational data suggest that PTBD is superior for achieving complete drainage. 2-6 Because the preferred procedure remains uncertain, we aimed to compare PTBD and ERCP as the primary intervention in patients with cholestasis due to malignant hilar obstruction (MHO).",2020,,['Suspected Malignant Hilar Obstruction'],['Percutaneous vs Endoscopic Drainage'],[],"[{'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0205150', 'cui_str': 'Hilar'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",[],,0.0860146,,"[{'ForeName': 'B Joseph', 'Initials': 'BJ', 'LastName': 'Elmunzer', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, Charleston, South Carolina. Electronic address: elmunzer@musc.edu.'}, {'ForeName': 'Zachary L', 'Initials': 'ZL', 'LastName': 'Smith', 'Affiliation': 'Division of Gastroenterology and Liver Disease, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Tarnasky', 'Affiliation': 'Division of Gastroenterology, Methodist Dallas Medical Center, Dallas, Texas.'}, {'ForeName': 'Andrew Y', 'Initials': 'AY', 'LastName': 'Wang', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Yachimski', 'Affiliation': 'Division of Gastroenterology, Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Banovac', 'Affiliation': 'Division of Interventional Radiology, Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Buscaglia', 'Affiliation': 'Division of Gastroenterology, Stony Brook University, Stony Brook, New York.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Buxbaum', 'Affiliation': 'Division of Gastroenterology, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Amitabh', 'Initials': 'A', 'LastName': 'Chak', 'Affiliation': 'Division of Gastroenterology and Liver Disease, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Bradford', 'Initials': 'B', 'LastName': 'Chong', 'Affiliation': 'Division of Gastroenterology, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Coté', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Peter V', 'Initials': 'PV', 'LastName': 'Draganov', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Kulwinder', 'Initials': 'K', 'LastName': 'Dua', 'Affiliation': 'Division of Gastroenterology, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Durkalski', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Geller', 'Affiliation': 'Division of Interventional Radiology, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Laith H', 'Initials': 'LH', 'LastName': 'Jamil', 'Affiliation': 'Division of Gastroenterology, Cedars Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Rajesh N', 'Initials': 'RN', 'LastName': 'Keswani', 'Affiliation': 'Division of Gastroenterology, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Mouen A', 'Initials': 'MA', 'LastName': 'Khashab', 'Affiliation': 'Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, Maryland.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Law', 'Affiliation': 'Division of Gastroenterology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Simon K', 'Initials': 'SK', 'LastName': 'Lo', 'Affiliation': 'Division of Gastroenterology, Cedars Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'McCarthy', 'Affiliation': 'Division of Gastroenterology, Ohio State University, Columbus, Ohio.'}, {'ForeName': 'J Bayne', 'Initials': 'JB', 'LastName': 'Selby', 'Affiliation': 'Division of Interventional Radiology, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Vikesh K', 'Initials': 'VK', 'LastName': 'Singh', 'Affiliation': 'Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, Maryland.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Taylor', 'Affiliation': 'Division of Gastroenterology, Saint Louis University, St Louis, Missouri.'}, {'ForeName': 'Field F', 'Initials': 'FF', 'LastName': 'Willingham', 'Affiliation': 'Division of Digestive Diseases, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Spitzer', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Lydia D', 'Initials': 'LD', 'LastName': 'Foster', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.05.035'] 709,32458035,Simultaneous single-stage versus two-staged bilateral total knee arthroplasty: a prospective comparative study.,"PURPOSE The study aims to prospectively compare peri-operative morbidity and mortality of simultaneous single-stage bilateral total knee arthroplasty (SS BLTKA) with two-staged bilateral total knee arthroplasty (TS BLTKA) performed within 12 months of the first surgery. We hypothesized that SS BLTKA is as safe as TS BLTKA. METHODS Patients with a minimum follow-up of 12 months were included in this study. Oxford knee score and quality of life index SF12 was compared between the 2 groups at six weeks and six month follow-up. RESULTS SS BLTKA included 250 patients and TS BLTKA included 210 patients. The minimum time interval between two operations was three weeks (mean 1.6 months, range 3 weeks-12 months). There was no significant difference between the 2 groups in peri-operative mortality, surgical site infection, major peri-operative complications. There was no difference between the 2 groups in the Oxford knee score and quality of life index SF12 at 6-month follow-up. There was no difference in the range of knee flexion between the 2 groups at six months. Post-operative haemoglobin drop was significantly more in SS BLTKA patients and consequently, blood transfusion requirement was significantly higher in SS BLTKA. There was a significantly higher length of hospital stay and duration of surgery in TS BLTKA group. CONCLUSION There does not appear to be a difference in complication rates between the 2 groups. SS BLTKA seems to be a logical choice if both knees have severe osteoarthritis. Patients with severe cardiopulmonary compromise were excluded, and a unilateral procedure may be preferred in them.",2020,There was no difference between the 2 groups in the Oxford knee score and quality of life index SF12 at 6-month follow-up.,"['Patients with severe cardiopulmonary compromise', 'Patients with a minimum follow-up of 12\xa0months', '250 patients and TS BLTKA included 210 patients']","['Simultaneous single-stage versus two-staged bilateral total knee arthroplasty', 'simultaneous single-stage bilateral total knee arthroplasty (SS BLTKA) with two-staged bilateral total knee arthroplasty (TS BLTKA']","['blood transfusion requirement', 'length of hospital stay and duration of surgery', 'complication rates', 'peri-operative mortality, surgical site infection, major peri-operative complications', 'minimum time interval', 'Oxford knee score and quality of life index SF12', 'range of knee flexion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319559', 'cui_str': '210'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index'}, {'cui': 'C0576095', 'cui_str': 'Range of knee flexion'}]",250.0,0.0426341,There was no difference between the 2 groups in the Oxford knee score and quality of life index SF12 at 6-month follow-up.,"[{'ForeName': 'Tarun', 'Initials': 'T', 'LastName': 'Goyal', 'Affiliation': 'Department of Orthopaedics, All India Institute of Medical Sciences, Bathinda, Punjab, 151001, India. goyal.tarun@gmail.com.'}, {'ForeName': 'Md Quamar', 'Initials': 'MQ', 'LastName': 'Azam', 'Affiliation': 'Department of Trauma Surgery, All India Institute of Medical Sciences, Rishikesh, India.'}, {'ForeName': 'Anjum', 'Initials': 'A', 'LastName': 'Syed', 'Affiliation': 'Department of Radiodiagnosis, All India Institute of Medical Sciences, Rishikesh, India.'}, {'ForeName': 'Souvik', 'Initials': 'S', 'LastName': 'Paul', 'Affiliation': 'Department of Orthopaedics, All India Institute of Medical Sciences, Rishikesh, India.'}]",International orthopaedics,['10.1007/s00264-020-04642-6'] 710,32459651,A Wearable Technology Delivering a Web-Based Diabetes Prevention Program to People at High Risk of Type 2 Diabetes: Randomized Controlled Trial.,"BACKGROUND Intensive lifestyle interventions are effective in reducing the risk of type 2 diabetes, but the implementation of learnings from landmark studies is expensive and time consuming. The availability of digital lifestyle interventions is increasing, but evidence of their effectiveness is limited. OBJECTIVE This randomized controlled trial (RCT) aimed to test the feasibility of a web-based diabetes prevention program (DPP) with step-dependent feedback messages versus a standard web-based DPP in people with prediabetes. METHODS We employed a two-arm, parallel, single-blind RCT for people at high risk of developing diabetes. Patients with a hemoglobin A 1c (HbA 1c ) level of 39-47 mmol/mol were recruited from 21 general practices in London. The intervention integrated a smartphone app delivering a web-based DPP course with SMS texts incorporating motivational interviewing techniques and step-dependent feedback messages delivered via a wearable device over 12 months. The control group received the wearable technology and access to the web-based DDP but not the SMS texts. As this was a feasibility study, the primary aim was to estimate potential sample size at different stages of the study, including the size of the target study population and the proportion of participants who consented, were randomized, and completed follow-up. We also measured the main outcomes for a full-scale RCT, namely, change in weight and physical activity at 6- and 12-month follow-ups, and secondary outcomes, including changes in the HbA 1c level, blood pressure, waist circumference, waist-to-hip ratio, and lipid levels. RESULTS We enrolled 200 participants: 98 were randomized to the intervention and 102 were randomized to the control group. The follow-up rate was higher in the control group (87/102, 85.3%) than in the intervention group (69/98, 70%) at 12 months. There was no treatment effect on weight at 6 months (mean difference 0.15; 95% CI -0.93 to 1.23) or 12 months (mean difference 0.07 kg; 95% CI -1.29 to 1.44) or for physical activity levels at 6 months (mean difference -382.90 steps; 95% CI -860.65 to 94.85) or 12 months (mean difference 92.64 steps; 95% CI -380.92 to 566.20). We did not observe a treatment effect on the secondary outcomes measured at the 6-month or 12-month follow-up. For the intervention group, the mean weight was 92.33 (SD 15.67) kg at baseline, 91.34 (SD 16.04) kg at 6 months, and 89.41 (SD 14.93) kg at 12 months. For the control group, the mean weight was 92.59 (SD 17.43) kg at baseline, 91.71 (SD 16.48) kg at 6 months, and 91.10 (SD 15.82) kg at 12 months. In the intervention group, the mean physical activity was 7308.40 (SD 4911.93) steps at baseline, 5008.76 (SD 2733.22) steps at 6 months, and 4814.66 (SD 3419.65) steps at 12 months. In the control group, the mean physical activity was 7599.28 (SD 3881.04) steps at baseline, 6148.83 (SD 3433.77) steps at 6 months, and 5006.30 (SD 3681.1) steps at 12 months. CONCLUSIONS This study demonstrates that it is feasible to successfully recruit and retain patients in an RCT of a web-based DPP. TRIAL REGISTRATION ClinicalTrials.gov NCT02919397; http://clinicaltrials.gov/ct2/show/NCT02919397.",2020,We did not observe a treatment effect on the secondary outcomes measured at 6-month or 12-month follow-up.,"['people with pre-diabetes', 'People at High Risk of Type 2 Diabetes', 'We enrolled 200 participants: 98', 'people at high risk of developing diabetes', 'Patients with a hemoglobin A1c (HbA1c) level of 39-47 mmol/mol were recruited from 21 general practices in London']","['smartphone app delivering a web-based DPP course with SMS texts incorporating motivational interviewing techniques and step-dependent feedback messages delivered via a wearable device over 12 months', 'Wearable Technology Delivering a Web-Based Diabetes Prevention Program', 'web-based diabetes prevention program (DPP) with step-dependent feedback messages versus a standard web-based DPP']","['weight', 'PA levels', 'change in HbA1c, blood pressure, waist circumference, waist-to-hip ratio, and lipid levels', 'full-scale RCT, namely, change in weight and physical activity (PA']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0023973', 'cui_str': 'London'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C4076391', 'cui_str': 'Motivational interviewing technique'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C4505348', 'cui_str': 'Wearable Technology'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",200.0,0.204808,We did not observe a treatment effect on the secondary outcomes measured at 6-month or 12-month follow-up.,"[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Staite', 'Affiliation': ""Institute of Psychiatry, Psychology and Neurosciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bayley', 'Affiliation': ""Institute of Psychiatry, Psychology and Neurosciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Ebaa', 'Initials': 'E', 'LastName': 'Al-Ozairi', 'Affiliation': 'Faculty of Medicine, Department of Medicine & Dasman Diabetes Institute, Kuwait University, Al Kuwayt, Kuwait.'}, {'ForeName': 'Kurtis', 'Initials': 'K', 'LastName': 'Stewart', 'Affiliation': ""Institute of Psychiatry, Psychology and Neurosciences, King's College London, London, United Kingdom.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hopkins', 'Affiliation': ""King's College Hospital NHS Foundation Trust, King's Health Partners, London, United Kingdom.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rundle', 'Affiliation': ""South Thames Cleft Service, St Thomas' Hospital, London, United Kingdom.""}, {'ForeName': 'Neel', 'Initials': 'N', 'LastName': 'Basudev', 'Affiliation': 'Health Innovation Network, London, United Kingdom.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mohamedali', 'Affiliation': ""Institute of Psychiatry, Psychology and Neurosciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Khalida', 'Initials': 'K', 'LastName': 'Ismail', 'Affiliation': ""Institute of Psychiatry, Psychology and Neurosciences, King's College London, London, United Kingdom.""}]",JMIR mHealth and uHealth,['10.2196/15448'] 711,32487881,Design of a Study to Measure Patient-Perspectives in Adverse Event Reporting (the PPAR Study): Supplementary Study to the ASPIRe Trial.,"OBJECTIVES The primary objective of this study is to compare patient versus physician rankings of adverse event (AE) and adverse symptom (AS) severity after pelvic reconstructive surgery. Secondary objectives include to estimate the association between patient rankings of AEs/ASs with decision-making and quality-of-life outcomes and to determine whether patient perspective about AE/AS changes over time. METHODS This is a supplementary study, Patient-Perspectives in Adverse Event Reporting (PPAR), to the index trial, ASPIRe (Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design). During the trial, AEs/ASs will be assessed by physicians longitudinally every 6 months, which includes a determination of the AE/AS grade severity. For PPAR, additional patient perspective will be measured for 19 predetermined AEs/ASs at the time of identification and again at 12 and 36 months postoperatively. Decision-making and quality-of-life questionnaires will be collected at these time points. The primary outcome, the overall interrater agreement between patient and physician rankings for AE/AS severity, will be determined using a repeated-measures concordance correlation coefficient. RESULTS To date, the index trial has completed enrollment, and follow-up is ongoing. CONCLUSIONS The PPAR methods for incorporating patient perspective in the measurement of AEs/ASs to determine their agreement with physician ranking, long-term relevance, and impact on treatment decision making and quality of life are described. This will contribute to improved measurements of AEs/ASs in future research with the goal of improving patient counseling and informing expectations and treatment decision making.",2021,"The primary outcome, the overall interrater agreement between patient and physician rankings for AE/",['after pelvic reconstructive surgery'],['ASPIRe (Apical Suspension Repair for Vault Prolapse'],"['patient rankings of AEs/ASs with decision-making and quality-of-life outcomes', 'overall interrater agreement between patient and physician rankings for AE', 'adverse event (AE) and adverse symptom (AS) severity', 'Decision-making and quality-of-life questionnaires', 'patient perspective about AE/AS changes over time']","[{'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0524865', 'cui_str': 'Reconstruction - action'}]","[{'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0699794', 'cui_str': 'Rank'}, {'cui': 'C0324145', 'cui_str': 'Equus asinus'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.128049,"The primary outcome, the overall interrater agreement between patient and physician rankings for AE/","[{'ForeName': 'Vivian W', 'Initials': 'VW', 'LastName': 'Sung', 'Affiliation': 'From the Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Menefee', 'Affiliation': 'Division of Female Pelvic Medicine & Reconstructive Surgery, Department of Reproductive Medicine, UC San Diego Health System, San Diego, CA.'}, {'ForeName': 'Gena', 'Initials': 'G', 'LastName': 'Dunivan', 'Affiliation': 'Division of Urogynecology, Department of Obstetrics and Gynecology, University of New Mexico, Albuquerque, NM.'}, {'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Richter', 'Affiliation': 'Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Moalli', 'Affiliation': 'Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh Medical Center, Pittsburgh, PA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Weidner', 'Affiliation': 'Division of Urogynecology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Uduak Umoh', 'Initials': 'UU', 'LastName': 'Andy', 'Affiliation': 'Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Pennsylvania Health System, Philadelphia, PA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Jelovsek', 'Affiliation': ''}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Mazloomdoost', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Whitworth', 'Affiliation': 'RTI International, Research Triangle Park, NC.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': 'RTI International, Research Triangle Park, NC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Female pelvic medicine & reconstructive surgery,['10.1097/SPV.0000000000000845'] 712,32579812,Effect on Patient Safety of a Resident Physician Schedule without 24-Hour Shifts.,"BACKGROUND The effects on patient safety of eliminating extended-duration work shifts for resident physicians remain controversial. METHODS We conducted a multicenter, cluster-randomized, crossover trial comparing two schedules for pediatric resident physicians during their intensive care unit (ICU) rotations: extended-duration work schedules that included shifts of 24 hours or more (control schedules) and schedules that eliminated extended shifts and cycled resident physicians through day and night shifts of 16 hours or less (intervention schedules). The primary outcome was serious medical errors made by resident physicians, assessed by intensive surveillance, including direct observation and chart review. RESULTS The characteristics of ICU patients during the two work schedules were similar, but resident physician workload, described as the mean (±SD) number of ICU patients per resident physician, was higher during the intervention schedules than during the control schedules (8.8±2.8 vs. 6.7±2.2). Resident physicians made more serious errors during the intervention schedules than during the control schedules (97.1 vs. 79.0 per 1000 patient-days; relative risk, 1.53; 95% confidence interval [CI], 1.37 to 1.72; P<0.001). The number of serious errors unitwide were likewise higher during the intervention schedules (181.3 vs. 131.5 per 1000 patient-days; relative risk, 1.56; 95% CI, 1.43 to 1.71). There was wide variability among sites, however; errors were lower during intervention schedules than during control schedules at one site, rates were similar during the two schedules at two sites, and rates were higher during intervention schedules than during control schedules at three sites. In a secondary analysis that was adjusted for the number of patients per resident physician as a potential confounder, intervention schedules were no longer associated with an increase in errors. CONCLUSIONS Contrary to our hypothesis, resident physicians who were randomly assigned to schedules that eliminated extended shifts made more serious errors than resident physicians assigned to schedules with extended shifts, although the effect varied by site. The number of ICU patients cared for by each resident physician was higher during schedules that eliminated extended shifts. (Funded by the National Heart, Lung, and Blood Institute; ROSTERS ClinicalTrials.gov number, NCT02134847.).",2020,"The number of serious errors unitwide were likewise higher during the intervention schedules (181.3 vs. 131.5 per 1000 patient-days; relative risk, 1.56; 95% CI, 1.43 to 1.71).",['pediatric resident physicians during their intensive care unit (ICU) rotations'],[],"['number of serious errors unitwide', 'errors', 'serious errors', 'serious medical errors made by resident physicians, assessed by intensive surveillance, including direct observation and chart review']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0376531', 'cui_str': 'Errors, Medical'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0541653', 'cui_str': 'Chart evaluation by healthcare professional'}]",,0.0840156,"The number of serious errors unitwide were likewise higher during the intervention schedules (181.3 vs. 131.5 per 1000 patient-days; relative risk, 1.56; 95% CI, 1.43 to 1.71).","[{'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Landrigan', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Shadab A', 'Initials': 'SA', 'LastName': 'Rahman', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Sullivan', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vittinghoff', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Barger', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Sanderson', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Kenneth P', 'Initials': 'KP', 'LastName': 'Wright', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Conor S', 'Initials': 'CS', 'LastName': ""O'Brien"", 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Qadri', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'St Hilaire', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Ann C', 'Initials': 'AC', 'LastName': 'Halbower', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Segar', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'McGuire', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Vitiello', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Horacio O', 'Initials': 'HO', 'LastName': 'de la Iglesia', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Sue E', 'Initials': 'SE', 'LastName': 'Poynter', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Pearl L', 'Initials': 'PL', 'LastName': 'Yu', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Phyllis C', 'Initials': 'PC', 'LastName': 'Zee', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Lockley', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Stone', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Czeisler', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1900669'] 713,32446245,"Me, myself, bye: regional alterations in glutamate and the experience of ego dissolution with psilocybin.","There is growing interest in the therapeutic utility of psychedelic substances, like psilocybin, for disorders characterized by distortions of the self-experience, like depression. Accumulating preclinical evidence emphasizes the role of the glutamate system in the acute action of the drug on brain and behavior; however this has never been tested in humans. Following a double-blind, placebo-controlled, parallel group design, we utilized an ultra-high field multimodal brain imaging approach and demonstrated that psilocybin (0.17 mg/kg) induced region-dependent alterations in glutamate, which predicted distortions in the subjective experience of one's self (ego dissolution). Whereas higher levels of medial prefrontal cortical glutamate were associated with negatively experienced ego dissolution, lower levels in hippocampal glutamate were associated with positively experienced ego dissolution. Such findings provide further insights into the underlying neurobiological mechanisms of the psychedelic, as well as the baseline, state. Importantly, they may also provide a neurochemical basis for therapeutic effects as witnessed in ongoing clinical trials.",2020,"There is growing interest in the therapeutic utility of psychedelic substances, like psilocybin, for disorders characterized by distortions of the self-experience, like depression.",[],"['psilocybin', 'placebo']","['medial prefrontal cortical glutamate', 'hippocampal glutamate']",[],"[{'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}]",,0.0862072,"There is growing interest in the therapeutic utility of psychedelic substances, like psilocybin, for disorders characterized by distortions of the self-experience, like depression.","[{'ForeName': 'N L', 'Initials': 'NL', 'LastName': 'Mason', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands. natasha.mason@maastrichtuniversity.nl.'}, {'ForeName': 'K P C', 'Initials': 'KPC', 'LastName': 'Kuypers', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Müller', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Reckweg', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'D H Y', 'Initials': 'DHY', 'LastName': 'Tse', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'S W', 'Initials': 'SW', 'LastName': 'Toennes', 'Affiliation': 'Institute of Legal Medicine, University of Frankfurt, Kennedyallee 104, D-60596, Frankfurt/Main, Germany.'}, {'ForeName': 'N R P W', 'Initials': 'NRPW', 'LastName': 'Hutten', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'J F A', 'Initials': 'JFA', 'LastName': 'Jansen', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Maastricht University Medical Center+ (MUMC+), Maastricht, the Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Stiers', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Feilding', 'Affiliation': 'The Beckley Foundation, Beckley Park, Oxford, OX3 9SY, UK.'}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Ramaekers', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands. j.ramaekers@maastrichtuniversity.nl.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0718-8'] 714,32446842,Randomized Safety and Feasibility Trial of Ultra-Rapid Cooling Anesthesia for Intravitreal Injections.,"PURPOSE To test the safety and preliminary efficacy of rapid, nonpharmacologic anesthesia via cooling for intravitreal injections. DESIGN Single-center, randomized phase 1 dose-ranging safety study (ClinicalTrials.gov identifier, NCT02872012). PARTICIPANTS Adults 18 years of age or older with a diagnosis of exudative macular degeneration or diabetic macular edema requiring bilateral anti-vascular endothelial growth factor therapy were included. METHODS A handheld device was developed to provide anesthesia via cooling to a focal area on the surface of the eye before intravitreal treatment (IVT). In 22 patients undergoing bilateral IVT, 1 eye was randomized to receive standard of care (SOC) lidocaine-based anesthesia and the other eye received cooling-anesthesia at 1 of 5 different temperatures and cooling times. Subjective pain was assessed via the visual analog scale (VAS; range, 1-10) at 2 time points: (1) immediately after IVT and (2) 4 hours after IVT. Treated eyes were assessed for ocular safety 24 hours after IVT. MAIN OUTCOME MEASURES We determined the occurrence of adverse events in eyes treated with cooling anesthesia. Mean VAS pain scores immediately after IVT and 4 hours after IVT in eyes receiving cooling anesthesia were compared with eyes receiving SOC. RESULTS A total of 44 eyes were treated, 22 with cooling anesthesia and 22 with SOC. No dose-related toxicity was found with cooling anesthesia. Mild, transient adverse events were recorded in 32% of patients treated with cooling anesthesia versus 44% of patients receiving SOC. The mean±standard error of the mean (SEM) VAS pain scores immediately after intravitreal injection were 2.3 ± 0.4 for patients receiving SOC and 2.2 ± 0.6 in patients receiving -10° C cooling anesthesia (P = 0.8). Mean±SEM pain scores 4 hours after injection were 1.6 ± 0.4 for SOC and 1.2 ± 0.5 in the combined -10° C arms (P = 0.56). Total mean±SEM procedure time was 124 ± 5 seconds for patients treated with cooling anesthesia versus 395 ± 40 seconds for SOC (P < 0.0001). CONCLUSIONS Ultra-rapid cooling of the eye for anesthesia was well tolerated, with -10° C treatment resulting in comparable levels of anesthesia to SOC with a reduction in procedure time.",2020,"Mild, transient adverse events were recorded in 32% of patients treated with cooling anesthesia versus 44% of patients receiving SOC.","['22 patients undergoing', 'A total of 44 eyes were treated, 22 with cooling anesthesia and 22 with SOC', 'eyes treated with cooling anesthesia', 'Adults 18 years of age or older with a diagnosis of exudative macular degeneration or diabetic macular edema requiring bilateral anti-vascular endothelial growth factor therapy were included']","['standard of care (SOC) lidocaine-based anesthesia and the other eye received cooling-anesthesia', 'Ultra-Rapid Cooling Anesthesia', 'bilateral IVT', 'cooling anesthesia']","['Mild, transient adverse events', 'Mean VAS pain scores', 'Mean±SEM pain scores', 'toxicity', 'mean±standard error of the mean (SEM) VAS pain scores', 'Total mean±SEM procedure time', 'Subjective pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C2237660', 'cui_str': 'Wet Macular Degeneration'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C4727875', 'cui_str': 'Anti-vascular endothelial growth factor therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0699094', 'cui_str': 'Xylocaine'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",22.0,0.0922038,"Mild, transient adverse events were recorded in 32% of patients treated with cooling anesthesia versus 44% of patients receiving SOC.","[{'ForeName': 'Cagri G', 'Initials': 'CG', 'LastName': 'Besirli', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, W. K. Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan. Electronic address: cbesirli@med.umich.edu.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Smith', 'Affiliation': 'Department of Ophthalmology, Byers Eye Institute, Stanford University School of Medical, Palo Alto, California; iRenix Medical, Inc., Palo Alto, California.'}, {'ForeName': 'David N', 'Initials': 'DN', 'LastName': 'Zacks', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, W. K. Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Gardner', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, W. K. Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Pipe', 'Affiliation': 'Department of Mechanical Engineering, University of Michigan, Ann Arbor, Michigan; Department of Electrical Engineering and Computer Science, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Musch', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, W. K. Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan; Department of Epidemiology, School of Public Health, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Anjali R', 'Initials': 'AR', 'LastName': 'Shah', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, W. K. Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan.'}]",Ophthalmology. Retina,['10.1016/j.oret.2020.04.001'] 715,32447634,Gut Microbial Predictors of Type 2 Diabetes Remission Following Bariatric Surgery.,"PURPOSE Distinct anatomical rearrangements of the gastrointestinal tract achieved by various types of bariatric surgery cause changes in nutrient intake and gut microbiota. The contribution of such gut microbiota changes to remission of type 2 diabetes (T2D) remains unclear. AIM We examined gut microbiota changes following banded Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) in a randomised study, in relation to T2D remission. MATERIALS AND METHODS Whole-metagenome shotgun sequencing was carried out on paired stool samples at pre- and 1-year post-surgery collected from 44 participants with T2D randomised to banded Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG). Taxonomic composition and predicted functional potential of the gut bacteria were identified using HUMANn2, and annotated using MetaCyc. Five-day dietary records (analysed using FoodWorks v8.0), body weight and diabetes status were recorded at both time points. RESULTS RYGB participants had higher percentage excess weight loss than SG (p = 0.01), even though dietary intake was similar at 1-year post-surgery. Similar proportions achieved diabetes remission (HbA1c < 48 mmol/mol without medications) after either RYGB (68%) or SG (59%). RYGB resulted in increased abundances of Firmicutes and Proteobacteria, while SG resulted in increased Bacteroidetes. Pre-surgery, an increased abundance of Eubacteriaceae (p = 0.01) and Alistipes putredinis (p = 0.01) was observed in those who went on to remit from T2D post-surgery. Following surgery, Lachnospiraceae (p = 0.04) and Roseburia (p = 0.01) species were more abundant in those who had achieved T2D remission. CONCLUSIONS Specific stool bacterial taxa may signal likelihood of T2D remission after bariatric surgery which is potentially mediated by increases in Lachnospiraceae and Roseburia.",2020,"Pre-surgery, an increased abundance of Eubacteriaceae (p = 0.01) and Alistipes putredinis (p = 0.01) was observed in those who went on to remit from T2D post-surgery.","['Type 2 Diabetes Remission Following Bariatric Surgery', '44 participants with T2D randomised to']",['banded Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG'],"['body weight and diabetes status', 'abundances of Firmicutes and Proteobacteria, while SG resulted in increased Bacteroidetes', 'diabetes remission', 'Alistipes putredinis', 'abundance of Eubacteriaceae', 'Taxonomic composition and predicted functional potential of the gut bacteria', 'percentage excess weight loss']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0751985', 'cui_str': 'Proteobacteria'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1490417', 'cui_str': 'Alistipes'}, {'cui': 'C1210566', 'cui_str': 'Eubacteriaceae'}, {'cui': 'C0008903', 'cui_str': 'classification'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",44.0,0.0200876,"Pre-surgery, an increased abundance of Eubacteriaceae (p = 0.01) and Alistipes putredinis (p = 0.01) was observed in those who went on to remit from T2D post-surgery.","[{'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Davies', 'Affiliation': 'Department of Medicine, Faculty of medical and health sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': ""O'Sullivan"", 'Affiliation': 'Maurice Wilkins Centre, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Lindsay D', 'Initials': 'LD', 'LastName': 'Plank', 'Affiliation': 'Department of Surgery, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Rinki', 'Initials': 'R', 'LastName': 'Murphy', 'Affiliation': 'Department of Medicine, Faculty of medical and health sciences, University of Auckland, Auckland, New Zealand. r.murphy@auckland.ac.nz.'}]",Obesity surgery,['10.1007/s11695-020-04684-0'] 716,32453139,"Tanezumab for chronic low back pain: a randomized, double-blind, placebo- and active-controlled, phase 3 study of efficacy and safety.","ABSTRACT This randomized, double-blind, phase 3 study (56-week treatment; 24-week follow-up) assessed tanezumab in patients with chronic low back pain and history of inadequate response to standard-of-care analgesics (NCT02528253). Patients received placebo, subcutaneous tanezumab (5 or 10 mg every 8 weeks), or oral tramadol prolonged-release (100-300 mg/day). Primary endpoint was change in low back pain intensity (LBPI) at week 16 for tanezumab vs placebo. Key secondary endpoints were proportion of patients with ≥50% decrease in LBPI at week 16, change in Roland Morris Disability Questionnaire at week 16, and change in LBPI at week 2 for tanezumab vs placebo. Adverse events and joint safety were assessed through weeks 56 and 80, respectively. Tanezumab 10 mg met the primary endpoint by significantly improving LBPI at week 16 vs placebo; least squares (LS) mean (95% CI) difference = -0.40 (-0.76 to -0.04; P = 0.0281). Tanezumab 10 mg significantly improved all key secondary endpoints. Tanezumab 5 mg did not meet the primary endpoint (LS mean [95% CI] treatment difference vs placebo = -0.30 [-0.66 to 0.07; P = 0.1117]), preventing formal testing of key secondary endpoints for this dose. The proportion of patients with ≥50% improvement in LBPI at week 16 was 37.4% in the placebo group, 43.3% in the tanezumab 5 mg group (Odds ratio [95% CI] vs placebo = 1.28 [0.97 to 1.70; P = 0.0846]), and 46.3% in the tanezumab 10 mg group (Odds ratio [95% CI] vs placebo = 1.45 [1.09 to 1.91; P = 0.0101]). Prespecified joint safety events were more frequent with tanezumab 10 mg (2.6%) than tanezumab 5 mg (1.0%), tramadol (0.2%), or placebo (0%). Seven patients, all in the tanezumab 10 mg group (1.4%), underwent total joint replacement. In conclusion, tanezumab 10 mg significantly improved pain and function vs placebo in patients with difficult-to-treat chronic low back pain. Tanezumab was associated with a low rate of joint safety events, some requiring joint replacement.",2020,Tanezumab 5mg did not meet the primary endpoint (LS mean [95% CI] treatment difference versus placebo = -0.30,"['patients with chronic low back pain (CLBP) and history of inadequate response to standard-of-care analgesics (NCT02528253', 'chronic low back pain', 'patients with difficult-to-treat CLBP']","['Tanezumab', 'tramadol', 'placebo, subcutaneous tanezumab', 'tanezumab', 'placebo']","['LBPI', 'Roland Morris Disability Questionnaire (RMDQ', 'Low Back Pain Intensity (LBPI', 'pain and function', 'low rate of joint safety events', 'Adverse events and joint safety', 'efficacy and safety', 'Prespecified joint safety events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C2346819', 'cui_str': 'tanezumab'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.615278,Tanezumab 5mg did not meet the primary endpoint (LS mean [95% CI] treatment difference versus placebo = -0.30,"[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Markman', 'Affiliation': 'Translational Pain Research Program, Department of Neurosurgery, University of Rochester Medical Center, Rochester, NY, United States.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Bolash', 'Affiliation': 'Departments of Pain Management and Evidence Based Pain Research, Cleveland Clinic, Cleveland, OH, United States.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': 'McAlindon', 'Affiliation': 'Division of Rheumatology, Allergy & Immunology, Tufts Medical Center, Boston, OH, United States.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Kivitz', 'Affiliation': 'Altoona Center for Clinical Research, Duncansville, PA, United States.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Pombo-Suarez', 'Affiliation': 'Rheumatology Service, Rheumatology Service, Hospital Clinico Universitario Santiago, Santiago de Compostela, Spain.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Ohtori', 'Affiliation': 'Department of Orthopaedic Surgery, Chiba University, Chiba, Japan.'}, {'ForeName': 'Frank W', 'Initials': 'FW', 'LastName': 'Roemer', 'Affiliation': 'Department of Radiology, Boston University, Boston, MA, United States.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Li', 'Affiliation': 'Pfizer Inc, Collegeville, PA, United States. Dr. Li is now with the Eisai Inc, Woodcliff Lake, NJ, United States).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Viktrup', 'Affiliation': 'Eli Lilly & Company, Indianapolis, IN, United States.'}, {'ForeName': 'Candace', 'Initials': 'C', 'LastName': 'Bramson', 'Affiliation': 'Pfizer Inc, Groton, CT, United States.'}, {'ForeName': 'Christine R', 'Initials': 'CR', 'LastName': 'West', 'Affiliation': 'Pfizer Inc, Groton, CT, United States.'}, {'ForeName': 'Kenneth M', 'Initials': 'KM', 'LastName': 'Verburg', 'Affiliation': 'Pfizer Inc, Groton, CT, United States.'}]",Pain,['10.1097/j.pain.0000000000001928'] 717,32454191,Patient Perceptions in a Nonblinded Randomized Trial of Radiation Therapy Technologies: A Novel Survey Study Exploring Therapeutic Misconception.,"PURPOSE Therapeutic misconception is the tendency for a clinical trial participant to overlook the scientific objective of a clinical trial and instead believe that an experimental intervention is intended for personal therapeutic benefit. We sought to evaluate this tendency in the setting of a clinical trial of a new radiation therapy technology. METHODS Patients with left-sided, node positive breast cancer enrolled in a randomized clinical trial evaluating intensity modulated radiation therapy with deep inspiration breath hold (IMRT-DIBH) versus 3-dimensional conformal radiation therapy (3DCRT). Patients who enrolled completed surveys at baseline, after randomization, and upon completion of radiation therapy to evaluate expectations, satisfaction, and experiences. RESULTS Forty women participated in the survey study, with 20 in each arm. Most participants endorsed the perception that participation in the trial might result in better treatment than the current standard treatment (77%) and more medical attention than being off trial (54%). At baseline, most women (74%) believed that a new treatment technology is superior than an established one. Before randomization, 43% of participants believed IMRT-DIBH would be more effective than standard treatment with 3DCRT, none believed that 3DCRT would be more effective, 23% believed that they would be the same, and 34% did not know. None believed that IMRT-DIBH would cause worse long-term side effects, whereas 37% thought that 3DCRT would. Most (71%) reported that they would choose to be treated with IMRT-DIBH; none would have elected 3DCRT if given a choice. Nearly half (44%) in the 3DCRT arm wished that they had been assigned to the IMRT-DIBH arm; none in the IMRT-DIBH arm expressed a wish for crossover. CONCLUSIONS Most participants reported the perception that trial participation would result in better treatment and more medical attention than off trial, hallmarks of therapeutic misconception. Our observations provide empirical evidence of a fixed belief in the superiority of new technology and highlight the importance of adjusting expectations through informed consent to mitigate therapeutic misconception.",2020,"Nearly half (44%) in the 3DCRT arm wished that they had been assigned to the IMRT-DIBH arm; none in the IMRT-DIBH arm expressed a wish for crossover. ","['35 women surveyed', 'Patients with breast cancer enrolled']","['3DCRT', 'Radiotherapy Technologies', 'intensity modulated radiotherapy with deep inspiration breath hold (IMRT-DIBH) versus 3-dimensional conformal radiotherapy (3DCRT']",['medical attention'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0600521', 'cui_str': 'Conformal radiotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0235744', 'cui_str': 'Interrupted breathing'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",35.0,0.156869,"Nearly half (44%) in the 3DCRT arm wished that they had been assigned to the IMRT-DIBH arm; none in the IMRT-DIBH arm expressed a wish for crossover. ","[{'ForeName': 'Dean A', 'Initials': 'DA', 'LastName': 'Shumway', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Motomura', 'Affiliation': 'Center for Law and the Biosciences and Stanford Program in Neuroscience and Society, Stanford Law School, Stanford, California.'}, {'ForeName': 'Kent A', 'Initials': 'KA', 'LastName': 'Griffith', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Hayman', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Lori J', 'Initials': 'LJ', 'LastName': 'Pierce', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Reshma', 'Initials': 'R', 'LastName': 'Jagsi', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan. Electronic address: rjagsi@med.umich.edu.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.05.021'] 718,32457427,Early cessation of a randomised study in acute graft versus host disease: upfront mesenchymal stromal cells with corticosteroids versus corticosteroids alone.,,2020,,[],['corticosteroids versus corticosteroids alone'],[],[],"[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]",[],,0.0355741,,"[{'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Purtill', 'Affiliation': 'Department of Haematology, Fiona Stanley Hospital, Perth, WA, Australia. Duncan.purtill@health.wa.gov.au.'}, {'ForeName': 'Melita', 'Initials': 'M', 'LastName': 'Cirillo', 'Affiliation': 'Department of Haematology, Royal Perth Hospital, Perth, WA, Australia.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Fogarty', 'Affiliation': 'Cell and Tissue Therapies WA, Royal Perth Hospital, Perth, WA, Australia.'}, {'ForeName': 'Dino', 'Initials': 'D', 'LastName': 'Tan', 'Affiliation': 'Cell and Tissue Therapies WA, Royal Perth Hospital, Perth, WA, Australia.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Cooney', 'Affiliation': 'Department of Haematology, Fiona Stanley Hospital, Perth, WA, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Wright', 'Affiliation': 'Department of Haematology, Fiona Stanley Hospital, Perth, WA, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Cannell', 'Affiliation': 'Department of Haematology, Fiona Stanley Hospital, Perth, WA, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Herrmann', 'Affiliation': 'Department of Haematology, Royal Perth Hospital, Perth, WA, Australia.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Sturm', 'Affiliation': 'Cell and Tissue Therapies WA, Royal Perth Hospital, Perth, WA, Australia.'}]",Bone marrow transplantation,['10.1038/s41409-020-0955-9'] 719,32458362,Biliopancreatic Limb Length in One Anastomosis Gastric Bypass: Which Is the Best?,"BACKGROUND The use of one anastomosis gastric bypass (OAGB) is rapidly spreading. Concerns about biliary reflux and malabsorption with consequent nutritional deficits exist, so studies on biliopancreatic limb (BPL) adequate length in OAGB are required to balance excess weight loss in percentage (% EWL), resolution of comorbidities, and nutritional deficit. The purpose was to evaluate, at 2 years after OAGB, the effects of BPL length on weight loss, resolution of comorbidity, and nutritional deficiencies in patients. METHODS From January 2015 to January 2017, 180 patients were collected into three groups based BPL length: group A, 150 cm; group B, 180 cm; and group C, 200 cm. Aims were to compare %EWL, co-morbidity resolution rates, nutritional parameters, and morbidity/mortality in the three groups. RESULTS The total number of patients was 180: 60 for each group. One hundred seventy-two (95%) patients attended the 1-year follow-up (group A = 58; group B = 58, group C = 56). One hundred fifty-seven (87%) patients attended the 2-year follow-up (group A = 52 (87%); group B = 53 (88%); group C = 52 (87%)). There was no statistically significant difference in %EWL, %TWL, T2DM, and hypertension resolution rates among the groups. About vitamin deficiency, differences were not statistically significant. Iron and ferritin deficiency rate were statistically significant only between A and C groups. CONCLUSIONS According to our evidence, standardization of BPL length shorter than 200 cm is suggested, potentially minimizing malnutrition-related outcomes. Our study seems to show that a BPL of 150-180 cm is safe and effective in terms of EWL and comorbidity improvement with low malnutrition effects even in BMI > 50.",2020,"There was no statistically significant difference in %EWL, %TWL, T2DM, and hypertension resolution rates among the groups.","['From January 2015 to January 2017, 180 patients', 'One hundred seventy-two (95%) patients attended the 1-year follow-up (group A\u2009=\u200958; group B\u2009=\u200958, group C\u2009=\u200956', 'One Anastomosis Gastric Bypass', 'patients']",['anastomosis gastric bypass (OAGB'],"['weight loss, resolution of comorbidity, and nutritional deficiencies', 'Biliopancreatic Limb Length', 'Iron and ferritin deficiency rate', 'EWL, %TWL, T2DM, and hypertension resolution rates', 'EWL, co-morbidity resolution rates, nutritional parameters, and morbidity/mortality']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}]","[{'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C1261315', 'cui_str': 'Limb length'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",180.0,0.0341174,"There was no statistically significant difference in %EWL, %TWL, T2DM, and hypertension resolution rates among the groups.","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Pizza', 'Affiliation': 'Division of Surgery, Hospital ""A. Rizzoli"", Lacco Ameno, Naples, Italy. Francesco_pizza@libero.it.'}, {'ForeName': 'Francesco Saverio', 'Initials': 'FS', 'LastName': 'Lucido', 'Affiliation': 'Division of General, Mininvasive and Bariatric Surgery, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': ""D'Antonio"", 'Affiliation': 'Division of Surgery, Hospital ""A. Rizzoli"", Lacco Ameno, Naples, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Tolone', 'Affiliation': 'Division of General, Mininvasive and Bariatric Surgery, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Gambardella', 'Affiliation': 'Division of General, Mininvasive and Bariatric Surgery, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': ""Dell'Isola"", 'Affiliation': 'Department of Infectious Diseases, AORN ""Dei Colli"", Naples, Italy.'}, {'ForeName': 'Ludovico', 'Initials': 'L', 'LastName': 'Docimo', 'Affiliation': 'Division of General, Mininvasive and Bariatric Surgery, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Marvaso', 'Affiliation': 'Division of Surgery, Hospital ""A. Rizzoli"", Lacco Ameno, Naples, Italy.'}]",Obesity surgery,['10.1007/s11695-020-04687-x'] 720,32460584,Holistic Nursing in Practice: Mindfulness-Based Yoga as an Intervention to Manage Stress and Burnout.,"PURPOSE Effects of a mindfulness-based (MB) yoga practice on stress, burnout, and indicators of well-being among nurses and health care professionals (HCPs). DESIGN A randomized controlled trial, 80 HCPs assigned to either MB yoga intervention or control group. METHOD The MB yoga intervention group ( n  = 41) attended weekly yoga classes and practiced yoga independently. The control group ( n  = 39) did not receive the yoga intervention. Study participants completed pre- and postintervention questionnaires, instruments included (a) Perceived Stress Scale; (b) Maslach Burnout Inventory; (c) Vitality subscale of the Medical Outcomes Study Short Form-36; (d) Global Sleep Quality item, (e) Mindfulness Awareness Survey, and (f) subscale of the Brief Serenity Scale. Diurnal salivary cortisol and blood pressure were assessed pre and postintervention. RESULTS Significant improvements ( p  < .01) noted in MB yoga compared with control for self-reported factors, including stress (Perceived Stress Scale), burnout (Maslach Burnout Inventory), vitality (Medical Outcomes Study Short Form-36), sleep (GSQ), serenity/inner haven (IH), and mindfulness (Mindfulness Awareness Survey). Diurnal cortisol slopes and blood pressure were not significantly improved. CONCLUSION The MB yoga intervention had a statistically significant effect on the health and well-being of nurses and HCPs, most specifically for measures of stress; perceived stress, burnout, vitality, sleep quality, serenity, and mindfulness.",2021,"RESULTS Significant improvements ( p  < .01) noted in MB yoga compared with control for self-reported factors, including stress (Perceived Stress Scale), burnout (Maslach Burnout Inventory), vitality (Medical Outcomes Study Short Form-36), sleep (GSQ), serenity/inner haven (IH), and mindfulness (Mindfulness Awareness Survey).",[],"['yoga intervention', 'MB yoga intervention or control group', 'mindfulness-based (MB) yoga practice', 'MB yoga intervention', 'MB yoga intervention group ( n \u2009=\u200941) attended weekly yoga classes and practiced yoga independently']","['pre- and postintervention questionnaires, instruments included (a) Perceived Stress Scale; (b) Maslach Burnout Inventory; (c) Vitality subscale of the Medical Outcomes Study Short Form-36; (d) Global Sleep Quality item, (e) Mindfulness Awareness Survey, and (f) subscale of the Brief Serenity Scale', 'health and well-being of nurses and HCPs, most specifically for measures of stress; perceived stress, burnout, vitality, sleep quality, serenity, and mindfulness', 'MB yoga', 'Diurnal cortisol slopes and blood pressure', 'Diurnal salivary cortisol and blood pressure', 'stress (Perceived Stress Scale), burnout (Maslach Burnout Inventory), vitality (Medical Outcomes Study Short Form-36), sleep (GSQ), serenity/inner haven (IH), and mindfulness (Mindfulness Awareness Survey']",[],"[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205102', 'cui_str': 'Internal'}]",80.0,0.0182787,"RESULTS Significant improvements ( p  < .01) noted in MB yoga compared with control for self-reported factors, including stress (Perceived Stress Scale), burnout (Maslach Burnout Inventory), vitality (Medical Outcomes Study Short Form-36), sleep (GSQ), serenity/inner haven (IH), and mindfulness (Mindfulness Awareness Survey).","[{'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Hilcove', 'Affiliation': '24140HonorHealth Scottsdale Shea Medical Center.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Marceau', 'Affiliation': '24140HonorHealth Scottsdale Shea Medical Center.'}, {'ForeName': 'Prachi', 'Initials': 'P', 'LastName': 'Thekdi', 'Affiliation': '7864Arizona State University.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Larkey', 'Affiliation': '7864Arizona State University.'}, {'ForeName': 'Melanie A', 'Initials': 'MA', 'LastName': 'Brewer', 'Affiliation': '24140HonorHealth Scottsdale Shea Medical Center.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Jones', 'Affiliation': 'Rhodes University; 26697Stellenbosch University.'}]",Journal of holistic nursing : official journal of the American Holistic Nurses' Association,['10.1177/0898010120921587'] 721,32580164,REducing SEDENTary Behavior Among Mild to Moderate Cognitively Impaired Assisted Living Residents: A Pilot Randomized Controlled Trial (RESEDENT Study).,"Older adults in assisted living spend most of their day in sedentary behaviors, which may be detrimental to cognitive function. The primary purpose of this pilot study was to assess the feasibility of using a prompting device to reduce sitting time with light walking among older adults with mild to moderate cognitive impairment residing in an assisted living setting. A secondary purpose was to examine the effectiveness of the intervention on the residents' cognitive function, physical function, and quality of life. The participants (n = 25, mean age = 86.7 [5.3] years) were assigned in clusters into a two-arm 10-week single-site pilot randomized controlled trial. The intervention group was prompted with a watch to interrupt sedentary behaviors and partake in 10 min of light physical activity (i.e., walking) three times a day after a meal. The assessments included hip-worn accelerometers (Actical) and diaries, the Alzheimer's disease assessment scale-cognitive, Timed Up and Go, and the short-form 36 health survey. Adherence was high, as there were no dropouts, and over 70% of the participants completed over 80% of the prescribed physical activity bouts. Significant effects favoring the intervention were shown for all outcomes.",2020,Significant effects favoring the intervention were shown for all outcomes.,"['participants (n = 25, mean age = 86.7 [5.3] years', 'Mild to Moderate Cognitively Impaired Assisted Living Residents', 'older adults with mild to moderate cognitive impairment residing in an assisted living setting', 'Older adults']",['light walking'],"[""hip-worn accelerometers (Actical) and diaries, the Alzheimer's disease assessment scale-cognitive, Timed Up and Go, and the short-form 36 health survey"", ""residents' cognitive function, physical function, and quality of life"", 'Adherence']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}]","[{'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.0952938,Significant effects favoring the intervention were shown for all outcomes.,"[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Dillon', 'Affiliation': ''}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Prapavessis', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2019-0440'] 722,32453449,Collaborative care for primary care treatment of late-life depression in Singapore: Randomized controlled trial.,"BACKGROUND The effectiveness and portability of the collaborative care model in the primary care treatment of depression has not been demonstrated in many randomized controlled trials in healthcare settings across the world. We determined the effectiveness of collaborative care management of elderly depression in the primary care setting in Singapore. METHOD Eligible participants with depressive symptoms were randomized to 6-month duration usual care (UC, N = 112) or collaborative care (CC, N = 102). Outcome measures were HDRS-17, GDS, BDI and SF-12 MCS QOL measured at 3, 6, and 12-month, care satisfaction at 6-month, and also measured on 120 participants who refused referral (non-receipt of care, NC). Primary outcome was HDRS-17 measure of depression severity, response and remission at 6-month. RESULTS HDRS scores in CC group compared to UC group were reduced more at 6-month (1.5 points difference in change from baseline), and also at 3 and 12-month, with similar observations of differences for GDS and BDI. There was significantly greater improvement for both CC and UC groups compared to NC group. The CC group was about 1.5 times more likely to show HDRS treatment response and remission, and more than two times likely to show GDS treatment response and remission than the UC and NC groups, as well as better quality of life improvement (P < .001) and better care satisfaction (P < .001). CONCLUSION Collaborative care is effective for primary care treatment of older persons with depression and is portable in diverse health care settings.",2020,"RESULTS HDRS scores in CC group compared to UC group were reduced more at 6-month","['older persons with depression', 'Primary Care Treatment of Late-Life Depression in Singapore', 'Eligible participants with depressive symptoms', 'elderly depression in the primary care setting in Singapore']","['collaborative care management', 'six-month duration usual care (UC, N\xa0=\xa0112) or collaborative care']","['care satisfaction', 'GDS treatment response and remission', 'HDRS scores', 'HDRS-17, GDS, BDI and SF-12 MCS QOL measured at 3-month, 6-month and 12-month, care satisfaction', 'quality of life improvement', 'HDRS-17 measure of depression severity, response and remission at 6-month', 'HDRS treatment response and remission']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1840333', 'cui_str': 'Hypoparathyroidism, deafness, renal disease syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0036221', 'cui_str': 'Mast cell sarcoma'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",120.0,0.0983118,"RESULTS HDRS scores in CC group compared to UC group were reduced more at 6-month","[{'ForeName': 'Tze Pin', 'Initials': 'TP', 'LastName': 'Ng', 'Affiliation': 'Department of Psychological Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Ma S Z', 'Initials': 'MSZ', 'LastName': 'Nyunt', 'Affiliation': 'Department of Psychological Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': 'Department of Psychological Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Department of Psychological Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Calvin S L', 'Initials': 'CSL', 'LastName': 'Fones', 'Affiliation': 'Department of Psychological Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Soo Meng', 'Initials': 'SM', 'LastName': 'Ko', 'Affiliation': 'Department of Psychological Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}]",International journal of geriatric psychiatry,['10.1002/gps.5353'] 723,32468396,Anxiety and Depression Reduction as Distal Outcomes of a College Transition Readiness Program for Adults with Autism.,"Young adults with autism spectrum disorder (ASD) experience increased rates of anxiety and depression which can impact academic success. The Stepped Transition in Education Program for Students with ASD (STEPS) applies cognitive-behavioral principles to help young adults with ASD improve their adjustment to postsecondary education. We aimed to determine if STEPS had an effect on anxiety and depression. Treatment-seeking adults with ASD (n = 32; Mage = 19.74) were randomized to STEPS or transition as usual (TAU; i.e., waitlist control group). STEPS participants evinced significantly greater declines in depressive symptoms from pre-treatment to post-treatment compared to the waitlist. Anxiety symptoms did not significantly change. Results suggest that transition support for young people with ASD may improve mental health.",2021,STEPS participants evinced significantly greater declines in depressive symptoms from pre-treatment to post-treatment compared to the waitlist.,"['Students with ASD (STEPS) applies cognitive-behavioral principles to help young adults with ASD', 'Treatment-seeking adults with ASD (n\u2009=\u200932; Mage\u2009=\u200919.74', 'Young adults with autism spectrum disorder', 'Adults with Autism', 'young people with ASD']","['STEPS', 'College Transition Readiness Program']","['Anxiety symptoms', 'Anxiety and Depression Reduction', 'mental health', 'rates of anxiety and depression', 'anxiety and depression', 'depressive symptoms']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.0373388,STEPS participants evinced significantly greater declines in depressive symptoms from pre-treatment to post-treatment compared to the waitlist.,"[{'ForeName': 'Nicole N', 'Initials': 'NN', 'LastName': 'Capriola-Hall', 'Affiliation': 'Center for Youth Development and Intervention, The University of Alabama, Box 870348, Tuscaloosa, AL, 35487-0348, USA. nncapriola@crimson.ua.edu.'}, {'ForeName': 'Alexis M', 'Initials': 'AM', 'LastName': 'Brewe', 'Affiliation': 'Center for Youth Development and Intervention, The University of Alabama, Box 870348, Tuscaloosa, AL, 35487-0348, USA.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Golt', 'Affiliation': 'Center for Youth Development and Intervention, The University of Alabama, Box 870348, Tuscaloosa, AL, 35487-0348, USA.'}, {'ForeName': 'Susan W', 'Initials': 'SW', 'LastName': 'White', 'Affiliation': 'Center for Youth Development and Intervention, The University of Alabama, Box 870348, Tuscaloosa, AL, 35487-0348, USA.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04549-6'] 724,32473640,"Omega-3 fatty acid exposure with a low-fat diet in patients with past hypertriglyceridemia-induced acute pancreatitis; an exploratory, randomized, open-label crossover study.","BACKGROUND Omega-3 fatty acids (OM3-FAs) are recommended with a low-fat diet for severe hypertriglyceridemia (SHTG), to reduce triglycerides and acute pancreatitis (AP) risk. A low-fat diet may reduce pancreatic lipase secretion, which is required to absorb OM3-ethyl esters (OM3-EEs), but not OM3-carboxylic acids (OM3-CAs). METHODS In this exploratory, randomized, open-label, crossover study, 15 patients with SHTG and previous AP were instructed to take OM3-CA (2 g or 4 g) and OM3-EE 4 g once daily for 4 weeks, while adhering to a low-fat diet. On day 28 of each treatment phase, a single dose was administered in the clinic with a liquid low-fat meal, to assess 24-h plasma exposure. Geometric least-squares mean ratios were used for between-treatment comparisons of baseline (day 0)-adjusted area under the plasma concentration versus time curves (AUC 0-24 ) and maximum plasma concentrations (C max ) for eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). RESULTS Before initiating OM3-FA treatment, mean baseline fasting plasma EPA + DHA concentrations (nmol/mL) were 723 for OM3-CA 2 g, 465 for OM3-CA 4 g and 522 for OM3-EE 4 g. At week 4, mean pre-dose fasting plasma EPA + DHA concentrations increased by similar amounts (+ 735 - + 768 nmol/mL) for each treatment. During the 24-h exposure assessment (day 28), mean plasma EPA + DHA increased from pre-dose to the maximum achieved concentration by + 32.7%, + 45.8% and + 3.1% with single doses of OM3-CA 2 g, OM3-CA 4 g and OM3-EE 4 g, respectively. Baseline-adjusted AUC 0-24 was 60% higher for OM3-CA 4 g than for OM3-EE 4 g and baseline-adjusted C max was 94% higher (both non-significant). CONCLUSIONS Greater 24-h exposure of OM3-CA versus OM3-EE was observed for some parameters when administered with a low-fat meal at the clinic on day 28. However, increases in pre-dose fasting plasma EPA + DHA over the preceding 4-week dosing period were similar between treatments, leading overall to non-significant differences in baseline (day 0)-adjusted AUC 0-24 and C max EPA + DHA values. It is not clear why the greater 24-h exposure of OM3-CA versus OM3-EE observed with a low-fat meal did not translate into significantly higher pre-dose fasting levels of DHA + EPA with longer-term use. TRIAL REGISTRATION ClinicalTrials.gov, NCT02189252, Registered 23 June 2014.",2020,"Baseline-adjusted AUC 0-24 was 60% higher for OM3-CA 4 g than for OM3-EE 4 g and baseline-adjusted C max was 94% higher (both non-significant). ","['15 patients with SHTG and previous AP', 'patients with past hypertriglyceridemia-induced acute pancreatitis']","['Omega-3 fatty acid exposure with a low-fat diet', 'Omega-3 fatty acids (OM3-FAs', 'OM3-EE 4\u2009g once daily for 4\u2009weeks, while adhering to a low-fat diet', 'OM3-CA', 'OM3-CA versus OM3-EE']","['DHA concentrations', 'mean plasma EPA\u2009+\u2009DHA', 'maximum plasma concentrations (C max ) for eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA', 'pre-dose fasting plasma EPA\u2009+\u2009DHA', 'mean baseline fasting plasma EPA\u2009+\u2009DHA concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0001339', 'cui_str': 'Acute pancreatitis'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0439565', 'cui_str': 'Pre-dose'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",15.0,0.0470296,"Baseline-adjusted AUC 0-24 was 60% higher for OM3-CA 4 g than for OM3-EE 4 g and baseline-adjusted C max was 94% higher (both non-significant). ","[{'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Dunbar', 'Affiliation': 'Cardiometabolic and Lipid Clinic, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, USA. r.l.dunbar@gmail.com.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gaudet', 'Affiliation': 'Lipidology Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Saguenay, QC, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Davidson', 'Affiliation': 'University of Chicago Pritzker School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Rensfeldt', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Nilsson', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Kvarnström', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Oscarsson', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}]",Lipids in health and disease,['10.1186/s12944-020-01295-7'] 725,32487184,Fatigue following radiotherapy of low-risk early breast cancer - a randomized controlled trial of intraoperative electron radiotherapy versus standard hypofractionated whole-breast radiotherapy: the COSMOPOLITAN trial (NCT03838419).,"BACKGROUND Fatigue is one of the most common and distressing side-effects of breast cancer radiotherapy. According to current guidelines, accelerated partial breast irradiation (APBI) may be considered as an alternative treatment option for women with early-stage low-risk breast cancer. One method for APBI is single-dose intraoperative radiotherapy (IORT) applied directly to the tumor bed during breast conserving surgery (BCS). The COSMOPOLITAN trial therefore aims to analyze the intensity of fatigue following single-shot IORT with electrons (IOERT) compared to conventional hypofractionated whole breast irradiation (WBI) in low risk early breast cancer patients. METHODS This trial is conducted as a multicenter, prospective, randomized, two-arm phase II study comparing the intensity of fatigue in early-stage breast cancer (cT1cN0cM0, tumor size < 2,5 cm, ER pos. Her2neu neg., age > 50 years) treated either with WBI or APBI after BCS. Secondary outcomes investigated are tumor control, overall survival (OS), disease-free survival (DFS), acute and chronic toxicity, quality of life (QoL) and cosmesis. A total of 202 patients will be randomized into two arms: Patients in arm A will receive WBI (40.05 Gy, 15 fractions) after surgical resection, while patients in arm B will receive IOERT (21 Gy to the 90%-isodose) during BCS. Fatigue will be assessed 12 weeks post surgery with the help of the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale. DISCUSSION The present trial aims to evaluate treatment response to compare single-shot intraoperative electron APBI to conventional WBI following BCS in early-stage low risk breast cancer patients. Fatigue is selected as the primary, patient-reported endpoint due its major clinical relevance. TRIAL REGISTRATION The study is prospectively registered on February 12th, 2019: Clinicaltrials.gov, NCT03838419. ""Intraoperative Electron Radiotherapy for Low-risk Early Breast Cancer (COSMOPOLITAN)"". STUDY STATUS Ongoing study. Start of recruitment was December 2019.",2020,"Fatigue will be assessed 12 weeks post surgery with the help of the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale. ","['low risk early breast cancer patients', 'women with early-stage low-risk breast cancer', 'low-risk early breast cancer', 'early-stage low risk breast cancer patients', '202 patients']","['radiotherapy', 'conventional hypofractionated whole breast irradiation (WBI', 'Intraoperative Electron Radiotherapy', 'intraoperative radiotherapy (IORT', 'WBI or APBI', 'intraoperative electron radiotherapy versus standard hypofractionated whole-breast radiotherapy', 'single-shot intraoperative electron APBI to conventional WBI following BCS', 'IOERT', 'single-shot IORT with electrons (IOERT', 'accelerated partial breast irradiation (APBI']","['Chronic Illness Therapy (FACIT) Fatigue Scale', 'tumor control, overall survival (OS), disease-free survival (DFS), acute and chronic toxicity, quality of life (QoL) and cosmesis', 'Fatigue']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0013852', 'cui_str': 'Electron'}, {'cui': 'C0338240', 'cui_str': 'Intraoperative radiation therapy'}, {'cui': 'C3896696', 'cui_str': 'Accelerated partial breast irradiation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}]","[{'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",202.0,0.13722,"Fatigue will be assessed 12 weeks post surgery with the help of the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale. ","[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Forster', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Jäkel', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Sati', 'Initials': 'S', 'LastName': 'Akbaba', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Krug', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Krempien', 'Affiliation': 'Department of Radiation Oncology, Helios Hospital Berlin-Buch, Berlin, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Uhl', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Matthias Felix', 'Initials': 'MF', 'LastName': 'Häfner', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'König', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Stefan Alexander', 'Initials': 'SA', 'LastName': 'Koerber', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Semi', 'Initials': 'S', 'LastName': 'Harrabi', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Bernhardt', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Rouven', 'Initials': 'R', 'LastName': 'Behnisch', 'Affiliation': 'Institute of Medical Biometry and Informatics, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Krisam', 'Affiliation': 'Institute of Medical Biometry and Informatics, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Hennigs', 'Affiliation': 'Department of Gynecology and Obstetrics, Heidelberg University, 69115, Heidelberg, Germany.'}, {'ForeName': 'Christof', 'Initials': 'C', 'LastName': 'Sohn', 'Affiliation': 'Department of Gynecology and Obstetrics, Heidelberg University, 69115, Heidelberg, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Heil', 'Affiliation': 'Department of Gynecology and Obstetrics, Heidelberg University, 69115, Heidelberg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Debus', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Hörner-Rieber', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany. juliane.hoerner-rieber@med.uni-heidelberg.de.'}]","Radiation oncology (London, England)",['10.1186/s13014-020-01581-9'] 726,32488745,Primary Roux-en-Y Gastric Bypass Results in Greater Weight Loss at 15-Year Follow-Up Compared with Secondary Roux-en-Y Gastric Bypass After Failure of Gastric Band or Mason McLean Vertical Gastroplasty.,"PURPOSE The aim of the study is to compare the outcomes of patients treated with secondary Roux-en-Y gastric bypass (RYGB) after adjustable gastric banding (AGB) or vertical banded gastroplasty (VBG) with those of patients having primary RYGB. MATERIALS AND METHODS Patients undergoing secondary RYGB after AGB or VBG between 1997 and 2004 with a minimal follow-up of 15 years were matched using a propensity score (according to gender, age, BMI, duration of follow-up) with comparable patients who underwent primary RYGB. RESULTS The mean follow-up was 16.50 years in the secondary RYGB group (N = 32) versus 16.33 years in the primary RYGB group (N = 32). Early postoperative complications rate was 6.25% in the secondary RYGBs versus 9.38% in the primary RYGBs (P = 1). Late postoperative complications and additional surgical procedures were 56.25% and 37.5% in the secondary and primary RYGB group, respectively (P = 0.21). Long-term (at 16-20 years) %TWL and %EWL were significantly lower (P < 0.01 and P = 0.013, respectively) after secondary RYGB (%TWL = 7.56%; %EWL = 17.15%) than after primary RYGB (%TWL = 24.51%; %EWL = 55.61%). Remission of obesity-related comorbidities was comparable (P > 0.05). Gastroesophageal reflux was more frequent after secondary RGYB-43.75% versus 25%, P < 0.05. Quality of life-Morehead-Ardelt II score (0.02 in secondary RYGB versus 0.69 in primary RYGB, P = 0.13), general self-assessment of health status and weight satisfaction were comparable. CONCLUSION Secondary RYGB after AGB or VBG is less efficient at weight loss, GERD remission and energy expenditure at 15 years after conversion. However, it is as effective for improvement/resolution of obesity-related comorbidities and is associated with similar QoL scores.",2020,"Gastroesophageal reflux was more frequent after secondary RGYB-43.75% versus 25%, P < 0.05.","['patients treated with secondary Roux-en-Y gastric bypass (RYGB) after adjustable gastric banding (AGB) or vertical banded gastroplasty (VBG) with those of patients having primary RYGB', 'Patients undergoing secondary RYGB after AGB or VBG between 1997 and 2004 with a minimal follow-up of 15\xa0years were matched using a propensity score (according to gender, age, BMI, duration of follow-up) with comparable patients who underwent primary RYGB']",['Secondary Roux-en-Y Gastric Bypass'],"['Late postoperative complications and additional surgical procedures', 'Weight Loss', 'Quality of life-Morehead-Ardelt II score', 'Early postoperative complications rate', 'Gastroesophageal reflux', 'general self-assessment of health status and weight satisfaction', 'weight loss, GERD remission and energy expenditure', 'Remission of obesity-related comorbidities']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C1960832', 'cui_str': 'Partitioning of stomach using band'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0017193', 'cui_str': 'Gastroplasty'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0730225', 'cui_str': '1997'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2718044', 'cui_str': 'Propensity Score'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]",,0.0211827,"Gastroesophageal reflux was more frequent after secondary RGYB-43.75% versus 25%, P < 0.05.","[{'ForeName': 'Jean Hubert', 'Initials': 'JH', 'LastName': 'Etienne', 'Affiliation': 'Digestive Surgery and Liver Transplantation Unit, Centre Hospitalier Universitaire de Nice, Archet II Hospital, Nice, 151 Route Saint Antoine de Ginestière, BP 3079, Nice Cedex 3, France.'}, {'ForeName': 'Niccolo', 'Initials': 'N', 'LastName': 'Petrucciani', 'Affiliation': 'Digestive Surgery and Liver Transplantation Unit, Centre Hospitalier Universitaire de Nice, Archet II Hospital, Nice, 151 Route Saint Antoine de Ginestière, BP 3079, Nice Cedex 3, France.'}, {'ForeName': 'Mailys', 'Initials': 'M', 'LastName': 'Goetschy', 'Affiliation': 'Institute of Demography, University of Strasbourg, Strasbourg, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Gugenheim', 'Affiliation': 'Digestive Surgery and Liver Transplantation Unit, Centre Hospitalier Universitaire de Nice, Archet II Hospital, Nice, 151 Route Saint Antoine de Ginestière, BP 3079, Nice Cedex 3, France.'}, {'ForeName': 'Anne Sophie', 'Initials': 'AS', 'LastName': 'Schneck', 'Affiliation': 'Digestive Surgery Unit, Centre Hospitalier Universitaire de Guadeloupe, Pointe-à Pitre, Les Abymes, Guadeloupe, France.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Iannelli', 'Affiliation': 'Digestive Surgery and Liver Transplantation Unit, Centre Hospitalier Universitaire de Nice, Archet II Hospital, Nice, 151 Route Saint Antoine de Ginestière, BP 3079, Nice Cedex 3, France. iannelli.a@chu-nice.fr.'}]",Obesity surgery,['10.1007/s11695-020-04728-5'] 727,32683645,Biomarkers of platelet activation and cardiovascular risk in the DAPT trial.,"Prolonged use of dual antiplatelet therapy (DAPT) post-percutaneous coronary intervention (PCI) has been shown to reduce the risk of major adverse cardiovascular events (MACE), but with increased bleeding. It remains unknown whether biomarkers of platelet activation may be useful for identifying patients at increased risk of MACE. The DAPT study was a randomized trial of 12 versus 30 months of DAPT in patients who underwent PCI. Serum biomarkers [myeloid-related protein (MRP)-8/14, P-selectin, soluble CD-40 ligand (sCD40L)] were assessed in 1399 patients early post-PCI. On-treatment platelet reactivity index (PRI) using VASP phosphorylation was assessed in 443 patients randomized to continued DAPT at 1 year. MACE was defined as CV death, MI, or ischemic stroke. Multivariable models were adjusted for baseline characteristics, index event, and stent type. A stepwise increase in the risk of MACE was observed with increasing tertiles of both MRP-8/14 and P-selectin (p-trend = 0.04 for both). After multivariable adjustment, the adjusted HR (95% CI) for MACE in patients in the top tertile was 1.94 (1.14-3.30) for MRP-8/14 and 1.62 (0.99-2.64) for P-selectin. In contrast, baseline sCD40L was not associated with CV risk. Among patients randomized to continued DAPT, higher on-treatment platelet reactivity was not significantly associated with risk of MACE (p-trend = 0.32; adj-HR T3 vs. T1 1.54, 95% CI 0.20-12.18) or bleeding (P-trend = 0.17; adj-HR 0.25, 95% CI 0.05-1.21). MRP-8/14 and soluble P-selectin may be useful for identifying patients at increased risk of MACE after PCI. The utility of on-treatment platelet function testing requires further study.Clinical Trial Registration https://www.clinicaltrials.gov . Unique identifier NCT00977938.",2021,"Among patients randomized to continued DAPT, higher on-treatment platelet reactivity was not significantly associated with risk of MACE (p-trend = 0.32; adj-HR T3 vs. T1 1.54, 95% CI 0.20-12.18) or bleeding (P-trend = 0.17; adj-HR 0.25, 95% CI 0.05-1.21).","['443 patients randomized to continued DAPT at 1\xa0year', '1399 patients early post-PCI', 'patients who underwent PCI']","['dual antiplatelet therapy (DAPT) post-percutaneous coronary intervention (PCI', 'MACE', 'DAPT']","['Serum biomarkers [myeloid-related protein (MRP)-8/14, P-selectin, soluble CD-40 ligand (sCD40L', 'CV death, MI, or ischemic stroke', 'bleeding', 'risk of MACE', 'treatment platelet reactivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439677', 'cui_str': 'Myeloid'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0134835', 'cui_str': 'Lymphocyte antigen CD62'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",443.0,0.105176,"Among patients randomized to continued DAPT, higher on-treatment platelet reactivity was not significantly associated with risk of MACE (p-trend = 0.32; adj-HR T3 vs. T1 1.54, 95% CI 0.20-12.18) or bleeding (P-trend = 0.17; adj-HR 0.25, 95% CI 0.05-1.21).","[{'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Berg', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. dberg1@bwh.harvard.edu.""}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Yeh', 'Affiliation': 'Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mauri', 'Affiliation': 'Medtronic, Minneapolis, MN, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Morrow', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Dean J', 'Initials': 'DJ', 'LastName': 'Kereiakes', 'Affiliation': 'The Christ Hospital Heart and Vascular Center, The Lindner Research Center, Cincinnati, OH, USA.'}, {'ForeName': 'Donald E', 'Initials': 'DE', 'LastName': 'Cutlip', 'Affiliation': 'Division of Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Gao', 'Affiliation': 'Baim Clinical Research Institute, Boston, MA, USA.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Jarolim', 'Affiliation': ""Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Alan D', 'Initials': 'AD', 'LastName': 'Michelson', 'Affiliation': ""Center for Platelet Research Studies, Dana-Farber/Boston Children's Cancer and Blood Disorders Center, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Frelinger', 'Affiliation': ""Center for Platelet Research Studies, Dana-Farber/Boston Children's Cancer and Blood Disorders Center, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Abby L', 'Initials': 'AL', 'LastName': 'Cange', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': ""O'Donoghue"", 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}]",Journal of thrombosis and thrombolysis,['10.1007/s11239-020-02221-5'] 728,32588891,Risk of Secondary Traumatic Stress in Treating Traumatized Military Populations: Results from the PTSD Clinicians Exchange.,"INTRODUCTION This study examined risk factors for secondary traumatic stress (STS) in behavioral health clinicians and whether access to the Post-Traumatic Stress Disorder (PTSD) Clinicians Exchange website mitigated STS risk. METHODS A diverse sample of clinicians (N = 605) treating traumatized military populations in Department of Veterans Affairs (VA), Department of Defense, and community practice settings were randomized to a newsletter-only control group or the exchange group. The exchange website included resources for treating PTSD and promoting clinician well-being. Online surveys were administered at 0-, 6-, and 12-months postrandomization. Regression analyses were used to examine the link among risk factors, exchange access, and STS. RESULTS Baseline clinician demographics, experience, total caseload, appeal of evidence-based practices (EBPs), and likelihood of adopting EBPs if required were not linked with STS at the 12-month assessment period. Providing care at the VA, more burnout, less compassion satisfaction, greater trauma caseload, less openness to new EBPs, and greater divergence from EBP procedures were linked with greater STS. Only burnout and divergence were associated with STS after accounting for other significant STS risk factors. Exchange and control group clinicians reported similar STS levels after accounting for burnout and divergence. CONCLUSIONS Given that burnout was linked with STS, future intervention may use techniques targeting burnout and STS (eg, emotion regulation strategies). Research exploring the link between divergence from EBPs and STS may inform EBP dissemination efforts and STS interventions. Finally, results highlight the need for research optimizing STS intervention efficacy among clinicians treating military populations.",2020,"Exchange and control group clinicians reported similar STS levels after accounting for burnout and divergence. ","['Treating Traumatized Military Populations', 'A diverse sample of clinicians (N\xa0=\xa0605) treating traumatized military populations in Department of Veterans Affairs (VA), Department of Defense, and community practice settings']",[],"['Baseline clinician demographics, experience, total caseload, appeal of evidence-based practices (EBPs), and likelihood of adopting EBPs', 'STS levels']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0009462', 'cui_str': 'Community'}]",[],"[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1510541', 'cui_str': 'Evidence-Based Practice'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0425382', 'cui_str': 'Adopted'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]",605.0,0.0367443,"Exchange and control group clinicians reported similar STS levels after accounting for burnout and divergence. ","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Penix', 'Affiliation': 'Military Psychiatry Branch, Walter Reed Army Institute of Research, 503 Robert Grant Avenue, Silver Spring, MD 20910.'}, {'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Clarke-Walper', 'Affiliation': 'Military Psychiatry Branch, Walter Reed Army Institute of Research, 503 Robert Grant Avenue, Silver Spring, MD 20910.'}, {'ForeName': 'Felicia L', 'Initials': 'FL', 'LastName': 'Trachtenberg', 'Affiliation': 'New England Research Institutes, Inc., 480 Pleasant Street, Watertown, MA 02472.'}, {'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Magnavita', 'Affiliation': 'New England Research Institutes, Inc., 480 Pleasant Street, Watertown, MA 02472.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Simon', 'Affiliation': 'Palo Alto Veterans Institute for Research, 3801 Miranda Avenue, Palo Alto, CA 94304.'}, {'ForeName': 'Kile', 'Initials': 'K', 'LastName': 'Ortigo', 'Affiliation': 'Dissemination and Training Division, National Center for PTSD, 795 Willow Road, Menlo Park, CA 94025.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Coleman', 'Affiliation': 'New England Research Institutes, Inc., 480 Pleasant Street, Watertown, MA 02472.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Marceau', 'Affiliation': 'New England Research Institutes, Inc., 480 Pleasant Street, Watertown, MA 02472.'}, {'ForeName': 'Josef I', 'Initials': 'JI', 'LastName': 'Ruzek', 'Affiliation': 'Dissemination and Training Division, National Center for PTSD, 795 Willow Road, Menlo Park, CA 94025.'}, {'ForeName': 'Raymond C', 'Initials': 'RC', 'LastName': 'Rosen', 'Affiliation': 'New England Research Institutes, Inc., 480 Pleasant Street, Watertown, MA 02472.'}, {'ForeName': 'Joshua E', 'Initials': 'JE', 'LastName': 'Wilk', 'Affiliation': 'Military Psychiatry Branch, Walter Reed Army Institute of Research, 503 Robert Grant Avenue, Silver Spring, MD 20910.'}]",Military medicine,['10.1093/milmed/usaa078'] 729,32591310,Machine-Learning-Based In-Hospital Mortality Prediction for Transcatheter Mitral Valve Repair in the United States.,"BACKGROUND Transcatheter mitral valve repair (TMVR) utilization has increased significantly in the United States over the last years. Yet, a risk-prediction tool for adverse events has not been developed. We aimed to generate a machine-learning-based algorithm to predict in-hospital mortality after TMVR. METHODS Patients who underwent TMVR from 2012 through 2015 were identified using the National Inpatient Sample database. The study population was randomly divided into a training set (n = 636) and a testing set (n = 213). Prediction models for in-hospital mortality were obtained using five supervised machine-learning classifiers. RESULTS A total of 849 TMVRs were analyzed in our study. The overall in-hospital mortality was 3.1%. A naïve Bayes (NB) model had the best discrimination for fifteen variables, with an area under the receiver-operating curve (AUC) of 0.83 (95% CI, 0.80-0.87), compared to 0.77 for logistic regression (95% CI, 0.58-0.95), 0.73 for an artificial neural network (95% CI, 0.55-0.91), and 0.67 for both a random forest and a support-vector machine (95% CI, 0.47-0.87). History of coronary artery disease, of chronic kidney disease, and smoking were the three most significant predictors of in-hospital mortality. CONCLUSIONS We developed a robust machine-learning-derived model to predict in-hospital mortality in patients undergoing TMVR. This model is promising for decision-making and deserves further clinical validation.",2021,The overall in-hospital mortality was 3.1%.,"['A total of 849 TMVRs', 'Patients who underwent TMVR from 2012 through 2015 were identified using the National Inpatient Sample database', 'patients undergoing TMVR']","['machine-learning-based algorithm', 'Transcatheter mitral valve', 'repair']",['hospital mortality'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]","[{'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0026264', 'cui_str': 'Mitral valve structure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}]",849.0,0.053033,The overall in-hospital mortality was 3.1%.,"[{'ForeName': 'Dagmar F', 'Initials': 'DF', 'LastName': 'Hernandez-Suarez', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, University of Puerto Rico School of Medicine, San Juan, PR, USA. Electronic address: dagmar.hernandez@upr.edu.'}, {'ForeName': 'Sagar', 'Initials': 'S', 'LastName': 'Ranka', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, University of Kansas School of Medicine, Kansas City, KS, USA.'}, {'ForeName': 'Yeunjung', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Azeem', 'Initials': 'A', 'LastName': 'Latib', 'Affiliation': 'Division of Cardiology, Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Wiley', 'Affiliation': 'Division of Cardiology, Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY, USA.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Lopez-Candales', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Duane S', 'Initials': 'DS', 'LastName': 'Pinto', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Maday C', 'Initials': 'MC', 'LastName': 'Gonzalez', 'Affiliation': 'Division of Cardiology, Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY, USA.'}, {'ForeName': 'Harish', 'Initials': 'H', 'LastName': 'Ramakrishna', 'Affiliation': 'Division of Cardiovascular and Thoracic Anesthesiology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Sanina', 'Affiliation': 'Division of Cardiology, Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY, USA.'}, {'ForeName': 'Brenda G', 'Initials': 'BG', 'LastName': 'Nieves-Rodriguez', 'Affiliation': 'Center for Collaborative Research in Health Disparities, University of Puerto Rico School of Medicine, San Juan, PR, USA.'}, {'ForeName': 'Jovaniel', 'Initials': 'J', 'LastName': 'Rodriguez-Maldonado', 'Affiliation': 'Center for Collaborative Research in Health Disparities, University of Puerto Rico School of Medicine, San Juan, PR, USA.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Feliu Maldonado', 'Affiliation': 'Center for Collaborative Research in Health Disparities, University of Puerto Rico School of Medicine, San Juan, PR, USA.'}, {'ForeName': 'Israel J', 'Initials': 'IJ', 'LastName': 'Rodriguez-Ruiz', 'Affiliation': 'Center for Collaborative Research in Health Disparities, University of Puerto Rico School of Medicine, San Juan, PR, USA.'}, {'ForeName': 'Istoni', 'Initials': 'I', 'LastName': ""da Luz Sant'Ana"", 'Affiliation': 'Center for Collaborative Research in Health Disparities, University of Puerto Rico School of Medicine, San Juan, PR, USA.'}, {'ForeName': 'Karlo A', 'Initials': 'KA', 'LastName': 'Wiley', 'Affiliation': 'College of Agriculture and Life Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Cox-Alomar', 'Affiliation': 'Division of Cardiology, Department of Medicine, Louisiana State University, New Orleans, LA, USA.'}, {'ForeName': 'Pedro A', 'Initials': 'PA', 'LastName': 'Villablanca', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Abiel', 'Initials': 'A', 'LastName': 'Roche-Lima', 'Affiliation': 'Center for Collaborative Research in Health Disparities, University of Puerto Rico School of Medicine, San Juan, PR, USA.'}]",Cardiovascular revascularization medicine : including molecular interventions,['10.1016/j.carrev.2020.06.017'] 730,32593555,Effectiveness of a brief advance directive intervention in primary care: a randomized clinical trial.,"OBJECTIVE To measure the effectiveness of a brief intervention aimed at increasing interest in and use of advanced directives (AD) among primary care patients. METHODS Randomized controlled trial. In the intervention arm, patients were given brief oral information and a leaflet on AD by General Practitioners (GPs), in the control group were briefly informed about the study's purpose. Outcome variables were the proportion of patients who expressed interest in AD and those who completed one. Covariates were sex, age, education, race, Charlson comorbidity index (CCI), religion, and possession of financial will. RESULTS Overall, 332 patients were recruited; 58 in the intervention and 36 in the control group expressed interest in AD (p = 0.033) and 18 (5.4 %) made an AD (nine in each group). Variables associated with interest were Caucasian race (odds ratio [OR], 1.88), the intervention (OR, 1.86), and CCI extreme scores (OR, 0.36). Variables associated with AD completion were primary education/no schooling (OR, 5.69) and fewer children (OR, 0.57). CONCLUSIONS A brief oral and written intervention delivered by GP significantly increased interest in AD and achieved a completion rate of 5.4 %, without differences with the control group. PRACTICE IMPLICATIONS AD interventions should focus on individuals already likely to be motivated.",2021,"CONCLUSIONS A brief oral and written intervention delivered by GP significantly increased interest in AD and achieved a completion rate of 5.4 %, without differences with the control group. ","['primary care', 'primary care patients']",['brief advance directive intervention'],"['CCI extreme scores', 'completion rate']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4546361', 'cui_str': 'Charlson Comorbidity Index'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",332.0,0.0561145,"CONCLUSIONS A brief oral and written intervention delivered by GP significantly increased interest in AD and achieved a completion rate of 5.4 %, without differences with the control group. ","[{'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Rando-Matos', 'Affiliation': ""Centre d'Atenció Primària Florida Nord, Direcció d'Atenció Primària Costa de Ponent, Catalan Health Institute (ICS), L'Hospitalet de Llobregat, Barcelona, Spain; University Institute in Primary Care Research Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain; Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), Spain. Electronic address: yrando@ambitcp.catsalut.net.""}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Vives-Argilagós', 'Affiliation': ""Centre d'Atenció Primària Florida Nord, Direcció d'Atenció Primària Costa de Ponent, Catalan Health Institute (ICS), L'Hospitalet de Llobregat, Barcelona, Spain. Electronic address: 22793ava@gmail.com.""}, {'ForeName': 'Estrella', 'Initials': 'E', 'LastName': 'Rodero-Pérez', 'Affiliation': ""Centre d'Atenció Primària Florida Nord, Direcció d'Atenció Primària Costa de Ponent, Catalan Health Institute (ICS), L'Hospitalet de Llobregat, Barcelona, Spain. Electronic address: 24698erp@gmail.com.""}, {'ForeName': 'Lluís', 'Initials': 'L', 'LastName': 'Solsona-Díaz', 'Affiliation': ""Centre d'Atenció Primària Florida Nord, Direcció d'Atenció Primària Costa de Ponent, Catalan Health Institute (ICS), L'Hospitalet de Llobregat, Barcelona, Spain. Electronic address: lsolsona@ambitcp.catsalut.net.""}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Ballvé-Moreno', 'Affiliation': ""Centre d'Atenció Primària Florida Nord, Direcció d'Atenció Primària Costa de Ponent, Catalan Health Institute (ICS), L'Hospitalet de Llobregat, Barcelona, Spain; Universitat de Barcelona, Barcelona, Spain. Electronic address: ballvejl@gmail.com.""}, {'ForeName': 'Noemí', 'Initials': 'N', 'LastName': 'Moreno-Farrés', 'Affiliation': ""Centre d'Atenció Primària Florida Nord, Direcció d'Atenció Primària Costa de Ponent, Catalan Health Institute (ICS), L'Hospitalet de Llobregat, Barcelona, Spain. Electronic address: nmoreno@ambitcp.catsalut.net.""}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Sorando-Alastruey', 'Affiliation': ""Centre d'Atenció Primària Florida Nord, Direcció d'Atenció Primària Costa de Ponent, Catalan Health Institute (ICS), L'Hospitalet de Llobregat, Barcelona, Spain. Electronic address: rsorando@ambitcp.catsalut.net.""}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Adroer-Martori', 'Affiliation': ""Centre d'Atenció Primària Florida Nord, Direcció d'Atenció Primària Costa de Ponent, Catalan Health Institute (ICS), L'Hospitalet de Llobregat, Barcelona, Spain. Electronic address: madroer@ambitcp.catsalut.net.""}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Sanfeliu-Soto', 'Affiliation': ""Centre d'Atenció Primària Florida Nord, Direcció d'Atenció Primària Costa de Ponent, Catalan Health Institute (ICS), L'Hospitalet de Llobregat, Barcelona, Spain. Electronic address: nsanfeliu@ambitcp.catsalut.net.""}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Almeda-Ortega', 'Affiliation': ""University Institute in Primary Care Research Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain; Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), Spain; Unitat de Suport a la Recerca Costa de Ponent, Direcció d'Atenció Primària Costa de Ponent, Catalan Health Institute (ICS), Cornellà de Llobregat, Barcelona, Spain. Electronic address: jalmeda@ambitcp.catsalut.net.""}]",Patient education and counseling,['10.1016/j.pec.2020.06.018'] 731,32467054,Severe perioperative morbidity after robot-assisted versus conventional laparoscopy in gynecologic oncology: Results of the randomized ROBOGYN-1004 trial.,"OBJECTIVE In gynecologic oncology, minimally invasive surgery using conventional laparoscopy (CL) decreases the incidence of severe morbidity compared to open surgery. In 2005, robot-assisted laparoscopy (RL) was approved for use in gynecology in the US. This study aimed to assess whether RL is superior to CL in terms of morbidity incidence. METHODS ROBOGYN-1004 (ClinicalTrials.gov, NCT01247779) was a multicenter, phase III, superiority randomized trial that compared RL and CL in patients with gynecologic cancer requiring minimally invasive surgery. Patients were recruited between 2010 and 2015. The primary endpoint was incidence of severe perioperative morbidity (severe complications during or 6 months after surgery). RESULTS Overall, 369 of 385 patients were included in the as-treated analysis: 176 and 193 underwent RL and CL, respectively. The median operating time for RL was 190 (range, 75-432) minutes and for CL was 145 (33-407) minutes (p < 0.001). The blood loss volumes for the corresponding procedures were 100 (0-2500) and 50 (0-1000) mL (p = 0.003), respectively. The overall rates of conversion to open surgery for the corresponding procedures were 7% (10/176) and 5% (10/193), respectively (p = 0.52). Severe perioperative morbidity occurred in 28% (49/176) and 21% (41/192) of patients who underwent RL and CL, respectively (p = 0.15). At a median follow-up of 25.1 months (range, 0.6-78.2), no significant differences in overall and disease-free survival were observed between the groups. CONCLUSIONS RL was not found superior to CL with regard to the incidence of severe perioperative morbidity in patients with gynecologic cancer. In addition, RL involved a longer operating time than CL.",2020,"CONCLUSIONS RL was not found superior to CL with regard to the incidence of severe perioperative morbidity in patients with gynecologic cancer.","['Patients were recruited between 2010 and 2015', 'patients with gynecologic cancer requiring minimally invasive surgery', 'gynecologic oncology', 'patients with gynecologic cancer', '369 of 385 patients were included in the as-treated analysis']","['conventional laparoscopy (CL', 'RL and CL', 'robot-assisted laparoscopy (RL', 'robot-assisted versus conventional laparoscopy', 'RL']","['Severe perioperative morbidity', 'median operating time for RL', 'severe perioperative morbidity (severe complications', 'overall and disease-free survival', 'severe perioperative morbidity', 'severe morbidity', 'overall rates of conversion to open surgery', 'blood loss volumes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0699889', 'cui_str': 'Female reproductive neoplasm malignant NOS'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C1321164', 'cui_str': 'Gynecological oncology'}, {'cui': 'C4517751', 'cui_str': '385'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C3494226', 'cui_str': 'Conversion to an Open Procedure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",385.0,0.185524,"CONCLUSIONS RL was not found superior to CL with regard to the incidence of severe perioperative morbidity in patients with gynecologic cancer.","[{'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Narducci', 'Affiliation': 'Oscar Lambret Cancer Center, Lille, France. Electronic address: f-narducci@o-lambret.fr.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Bogart', 'Affiliation': 'Oscar Lambret Cancer Center, Lille, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hebert', 'Affiliation': 'Tours University Hospital, Tours, France.'}, {'ForeName': 'Tristan', 'Initials': 'T', 'LastName': 'Gauthier', 'Affiliation': 'Limoges University Hospital, Limoges, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Collinet', 'Affiliation': 'Lille University Hospital, Lille, France.'}, {'ForeName': 'Jean Marc', 'Initials': 'JM', 'LastName': 'Classe', 'Affiliation': ""Institut de Cancérologie de l'Ouest, Nantes, France.""}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Lecuru', 'Affiliation': 'Georges-Pompidou University Hospital, Paris, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Delest', 'Affiliation': 'Polyclinique Bordeaux Nord Aquitaine, Bordeaux, France.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Motton', 'Affiliation': 'Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Conri', 'Affiliation': 'Bordeaux University Hospital, Bordeaux, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ferrer', 'Affiliation': 'Nimes University Hospital, Nimes, France.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Marchal', 'Affiliation': 'CRAN, UMR 7039, Université de Lorraine, CNRS Institut de Cancérologie de Lorraine Vandoeuvre-les-Nancy, France.'}, {'ForeName': 'Gwenael', 'Initials': 'G', 'LastName': 'Ferron', 'Affiliation': 'Institut Claudius Regaud Cancer Center, Toulouse, France.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Probst', 'Affiliation': 'Oscar Lambret Cancer Center, Lille, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Thery', 'Affiliation': 'Oscar Lambret Cancer Center, Lille, France.'}, {'ForeName': 'Marie-Cécile', 'Initials': 'MC', 'LastName': 'Le Deley', 'Affiliation': 'Oscar Lambret Cancer Center, Lille, France; Université Paris-Saclay, Université Paris-Sud, UVSQ, CESP, INSERM, Villejuif, France.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Lefebvre', 'Affiliation': 'Oscar Lambret Cancer Center, Lille, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Francon', 'Affiliation': 'Institut Paoli Calmettes Cancer Center, Marseille, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Leblanc', 'Affiliation': 'Oscar Lambret Cancer Center, Lille, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lambaudie', 'Affiliation': 'Institut Paoli Calmettes Cancer Center, Marseille, France.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.05.010'] 732,32473974,"Bimekizumab for patients with moderate to severe plaque psoriasis: 60-week results from BE ABLE 2, a randomized, double-blinded, placebo-controlled, phase 2b extension study.","BACKGROUND Dual neutralization of both interleukin 17A and 17F with the monoclonal antibody bimekizumab may have greater efficacy in psoriasis than neutralization of interleukin 17A alone. OBJECTIVE To provide longer-term efficacy and safety data for bimekizumab from a phase 2b extension study in patients with moderate to severe psoriasis (BE ABLE 2). METHODS After the 12-week initial study (BE ABLE 1), patients who had a 90% improvement in Psoriasis Area and Severity Index (PASI 90) at week 12 received bimekizumab 64, 160, or 320 mg for an additional 48 weeks (60 weeks in total). The primary objective was safety. RESULTS Across all dose groups (N = 217), initial PASI 90 responders generally maintained high levels of efficacy through week 60: PASI 90, 80% to 100%; 100% improvement in PASI, 69% to 83%; Investigator's Global Assessment score 0 or 1, 78% to 100% (all nonresponder imputation). Incidence of serious treatment-emergent adverse events was 15/217 (6.9%). No cases of inflammatory bowel disease, major adverse cardiovascular events, or suicidal ideation or behavior were reported. LIMITATIONS Low numbers in the bimekizumab 64 mg group (n = 15). The majority of 60-week data reported here are primarily for the week 12 PASI 90 responders only. CONCLUSION Bimekizumab response rates were maintained through week 60. A substantial proportion of patients achieved complete skin clearance. Bimekizumab was generally well tolerated.",2020,"Across all dose groups (N = 217), initial PASI90 responders generally maintained high levels of efficacy through week 60: PASI90, 80-100%; PASI100, 69-83%; Investigator's Global Assessment 0/1, 78-100% (all non-responder imputation).","['patients with moderate-to-severe plaque psoriasis', 'patients who had a Psoriasis Area and Severity Index (PASI) 90 response at week 12 received', 'patients with moderate-to-severe psoriasis (BE ABLE 2, NCT03010527']","['Bimekizumab', 'bimekizumab', 'PASI90', 'placebo']","['tolerated', 'complete skin clearance', 'safety', 'Bimekizumab response rates', 'Incidence of serious treatment-emergent adverse events', 'inflammatory bowel disease, MACE, or suicidal ideation/behavior']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]","[{'cui': 'C4519734', 'cui_str': 'bimekizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4519734', 'cui_str': 'bimekizumab'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.165099,"Across all dose groups (N = 217), initial PASI90 responders generally maintained high levels of efficacy through week 60: PASI90, 80-100%; PASI100, 69-83%; Investigator's Global Assessment 0/1, 78-100% (all non-responder imputation).","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, Oregon. Electronic address: ablauvelt@oregonmedicalresearch.com.'}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Papp', 'Affiliation': 'Probity Medical Research and K. Papp Clinical Research, Waterloo, and University of Toronto, Toronto, Ontario.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Merola', 'Affiliation': ""Harvard Medical School, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Alice B', 'Initials': 'AB', 'LastName': 'Gottlieb', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Cross', 'Affiliation': 'UCB Biosciences Inc, Raleigh, North Carolina.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Madden', 'Affiliation': 'UCB Biosciences Inc, Raleigh, North Carolina.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'UCB Biosciences Inc, Raleigh, North Carolina.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Cioffi', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Christopher E M', 'Initials': 'CEM', 'LastName': 'Griffiths', 'Affiliation': 'Salford Royal Hospital, University of Manchester, Manchester NIHR Biomedical Research Centre, Manchester, United Kingdom.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.05.105'] 733,32475312,"Modest Sodium Reduction Increases Circulating Short-Chain Fatty Acids in Untreated Hypertensives: A Randomized, Double-Blind, Placebo-Controlled Trial.","High-sodium diet may modulate the gut microbiome. Given the circulating short-chain fatty acids (SCFAs) are microbial in origin, we tested the hypothesis that the modest sodium reduction would alter circulating SCFA concentrations among untreated hypertensives, and the changes would be associated with reduced blood pressure and improved cardiovascular phenotypes. A total of 145 participants (42% blacks, 19% Asian, and 34% females) were included from a randomized, double-blind, placebo-controlled cross-over trial of sodium reduction with slow sodium or placebo tablets, each for 6 weeks. Targeted circulating SCFA profiling was performed in paired serum samples, which were collected at the end of each period, so as all outcome measures. Sodium reduction increased all 8 SCFAs, among which the increases in 2-methylbutyrate, butyrate, hexanoate, isobutyrate, and valerate were statistically significant ( P s<0.05). Also, increased SCFAs were associated with decreased blood pressure and improved arterial compliance. There were significant sex differences of SCFAs in response to sodium reduction ( P s<0.05). When stratified by sex, the increases in butyrate, hexanoate, isobutyrate, isovalerate, and valerate were significant in females only ( P s<0.05), not in males ( P s>0.05). In females, changes in isobutyrate, isovalerate, and 2-methylbutyrate were inversely associated with reduced blood pressures ( P s<0.05). Increased valerate was associated with decreased carotid-femoral pulse wave velocity ( P =0.040). Our results show that dietary sodium reduction increases circulating SCFAs, supporting that dietary sodium may influence the gut microbiome in humans. There is a sex difference in SCFA response to sodium reduction. Moreover, increased SCFAs are associated with decreased blood pressures and improved arterial compliance. Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT00152074.",2020,Increased valerate was associated with decreased carotid-femoral pulse wave velocity ( P =0.040).,"['145 participants (42% blacks, 19% Asian, and 34% females', 'Untreated Hypertensives']","['placebo-controlled cross-over trial of sodium reduction with slow sodium or placebo tablets', 'Modest Sodium Reduction Increases Circulating Short-Chain Fatty Acids', 'Placebo', 'High-sodium diet']","['blood pressures and improved arterial compliance', 'Sodium reduction', 'SCFA response', 'blood pressures', '2-methylbutyrate, butyrate, hexanoate, isobutyrate, and valerate', 'circulating SCFA concentrations', 'blood pressure and improved cardiovascular phenotypes', 'carotid-femoral pulse wave velocity', 'blood pressure and improved arterial compliance', 'butyrate, hexanoate, isobutyrate, isovalerate, and valerate']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0452340', 'cui_str': 'High sodium diet'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0046367', 'cui_str': '2-methylbutyrate'}, {'cui': 'C0006521', 'cui_str': 'Butyrates'}, {'cui': 'C0121652', 'cui_str': 'hexanoate'}, {'cui': 'C0042280', 'cui_str': 'Pentanoates'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}]",145.0,0.135264,Increased valerate was associated with decreased carotid-femoral pulse wave velocity ( P =0.040).,"[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'From the Department of Medicine, Georgia Prevention Institute, Medical College of Georgia, Augusta University, Augusta, GA (L.C., Y.D., Y.H., G.A.H., H.Z.).'}, {'ForeName': 'Feng J', 'Initials': 'FJ', 'LastName': 'He', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom (F.J.H., C.W.).'}, {'ForeName': 'Yanbin', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'From the Department of Medicine, Georgia Prevention Institute, Medical College of Georgia, Augusta University, Augusta, GA (L.C., Y.D., Y.H., G.A.H., H.Z.).'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'From the Department of Medicine, Georgia Prevention Institute, Medical College of Georgia, Augusta University, Augusta, GA (L.C., Y.D., Y.H., G.A.H., H.Z.).'}, {'ForeName': 'Changqiong', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom (F.J.H., C.W.).'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Harshfield', 'Affiliation': 'From the Department of Medicine, Georgia Prevention Institute, Medical College of Georgia, Augusta University, Augusta, GA (L.C., Y.D., Y.H., G.A.H., H.Z.).'}, {'ForeName': 'Haidong', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'From the Department of Medicine, Georgia Prevention Institute, Medical College of Georgia, Augusta University, Augusta, GA (L.C., Y.D., Y.H., G.A.H., H.Z.).'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.14800'] 734,32475360,"Vitamin D 3 reduces risk of cardiovascular and liver diseases by lowering homocysteine levels: double-blinded, randomised, placebo-controlled trial.","The objective of this study was to evaluate the effect of vitamin D3 on total homocysteine (tHcy) and C-reactive protein (CRP) levels and liver and kidney function tests in overweight women with vitamin D deficiency. Therefore, a randomised, double-blind placebo, controlled clinical trial was conducted on 100 eligible women. Subjects were randomly divided into two groups: the placebo (n 50) and the vitamin D (n 50) which received 1250 µg vitamin D3 per week for 2 months. The participants' 25-hydroxyvitamin D (25(OH)D), tHcy, CRP, alanine aminotransferase (ALT), aspartate aminotransferase (AST), urea, creatinine and estimated glomerular filtration rate (eGFR) were measured and compared before and after treatment. Results showed that the tHcy, CRP, AST, ALT and eGFR levels after the 2nd month of vitamin D3 intervention were significantly (P < 0·001) decreased and the 25(OH)D, urea and creatinine levels were significantly (P < 0·001) increased in the treatment group. In the placebo group, no significant changes were identified throughout the follow-up period. In conclusion, vitamin D3 intervention with a treatment dose of 1250 µg/week for at least 2 months may help in lowering Hcy and CRP levels and may improve liver function tests, which in turn might help in minimising the risk of CVD and liver diseases among overweight women but negatively affect kidney function.",2021,"Results showed that the tHcy, CRP, AST, ALT, and eGFR levels after the second month of vitamin D3 intervention were significantly (p < 0.001) decreased and the 25(OH)D, urea, and creatinine levels were significantly (p < 0.001) increased in the treatment group.","['overweight women with vitamin D deficiency', 'one hundred eligible women']","['Vitamin D', 'placebo', 'vitamin D3 intervention', 'vitamin D', 'vitamin D3', '50,000 IU vitamin D3']","['tHcy, CRP, AST, ALT, and eGFR levels', 'risk of cardiovascular and liver diseases', '25(OH)D, urea, and creatinine levels', 'total homocysteine (tHcy) and C-reactive protein (CRP) levels and liver and kidney function tests', 'lowering homocysteine and CRP levels', '25- hydroxyvitamin D (25 (OH)D), tHcy, CRP, aspartate and alanine aminotransferases (AST, ALT), urea, creatinine and estimated glomerular filtration rate (eGFR', 'liver function tests']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0201975', 'cui_str': 'Creatinine measurement'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0085845', 'cui_str': 'Aspartate'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0023901', 'cui_str': 'Hepatic function panel'}]",100.0,0.469588,"Results showed that the tHcy, CRP, AST, ALT, and eGFR levels after the second month of vitamin D3 intervention were significantly (p < 0.001) decreased and the 25(OH)D, urea, and creatinine levels were significantly (p < 0.001) increased in the treatment group.","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Al-Bayyari', 'Affiliation': 'Department of Nutrition and Food Technology, Faculty of Al-Huson University College, Al-Balqa Applied University, Al-Salt, 19117, Jordan.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hailat', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Human Medicine, Michigan State University, East Lansing, MI48824, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Subih', 'Affiliation': 'Department of Nutrition and Food Technology, Faculty of Agriculture, Jordan University of Science and Technology, Irbid, 22110, Jordan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Alkhalidy', 'Affiliation': 'Department of Nutrition and Food Technology, Faculty of Agriculture, Jordan University of Science and Technology, Irbid, 22110, Jordan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Eaton', 'Affiliation': 'Department of Integrated Physiology and Health Sciences, Alma College, Alma, MI48801, USA.'}]",The British journal of nutrition,['10.1017/S0007114520001890'] 735,32489807,Very Early Versus Early Percutaneous Coronary Intervention in Patients with Decreased e-GFR after Successful Fibrinolytic Therapy.,"Background Pharmacoinvasive strategy (PIS) is the alternative approach to primary percutaneous coronary intervention (PCI) if PCI capable center isn't available especially in the developing countries. Our objective of the current study was to investigate the incidence of contrast induced nephropathy (CIN), the occurrence of no reflow phenomenon and major adverse cardiac events (MACE) in patients with decreased estimated glomerular filtration rate (e-GFR) after successful fibrinolytic therapy in order to assess the benefit from very early PCI strategy (within 3-12 hours) or early PCI strategy (within 12-24 hours). Methods This randomized clinical trial included 420 patients with STEMI. All participants were classified randomly into two groups according to the time of intervention; Group I patients were subjected to very early PCI (within 3-12 hours) and Group II patients were subjected to early PCI (within 12-24 hours) after receiving successful fibrinolytic therapy. Results The incidence of CIN in Group I was slightly higher than Group II (23 patients [10.7%] versus 19 patients [9.3%]) respectively, with no statistically significant difference between the two groups (P value = 0.625). The incidence of no-reflow phenomenon (TIMI 0-2 flow) after the procedure was higher in Group II, while TIMI 3 flow (normal flow) was significantly higher in Group I than Group II (184 [85.6%] vs. 153 [74.6%], respectively) with P value = 0.044. There was no statistically significant difference between the two groups regarding mortality and MACE. Conclusion The incidence of CIN was nearly equal in very early PCI (within 3-12 hours) versus early PCI (within 12-24 hours); however, the incidence of no-reflow phenomenon was significantly higher in patients subjected to early PCI (within 12-24 hours).",2020,"The incidence of no-reflow phenomenon (TIMI 0-2 flow) after the procedure was higher in Group II, while TIMI 3 flow (normal flow) was significantly higher in Group I than Group II (184 [85.6%] vs. 153 [74.6%], respectively) with P value = 0.044.","['patients with decreased estimated glomerular filtration rate (e-GFR) after successful', 'Patients with Decreased e-GFR after Successful Fibrinolytic Therapy', '420 patients with STEMI']","['fibrinolytic therapy', 'successful fibrinolytic therapy', '\n\n\nPharmacoinvasive strategy (PIS']","['mortality and MACE', 'incidence of CIN', 'incidence of no-reflow phenomenon (TIMI 0-2 flow', 'incidence of no-reflow phenomenon']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0040044', 'cui_str': 'Thrombolytic therapy'}, {'cui': 'C4517774', 'cui_str': '420'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}]","[{'cui': 'C0040044', 'cui_str': 'Thrombolytic therapy'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0232347', 'cui_str': 'No reflow vascular flow'}]",420.0,0.0315396,"The incidence of no-reflow phenomenon (TIMI 0-2 flow) after the procedure was higher in Group II, while TIMI 3 flow (normal flow) was significantly higher in Group I than Group II (184 [85.6%] vs. 153 [74.6%], respectively) with P value = 0.044.","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Khalfallah', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medicine, Tanta University, EG.'}, {'ForeName': 'Randa', 'Initials': 'R', 'LastName': 'Abdelmageed', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medicine, Tanta University, EG.'}, {'ForeName': 'Amany', 'Initials': 'A', 'LastName': 'Allaithy', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medicine, Tanta University, EG.'}]",Global heart,['10.5334/gh.794'] 736,32601120,Deep brain stimulation in early-stage Parkinson disease: Five-year outcomes.,"OBJECTIVE To report 5-year outcomes from the subthalamic nucleus (STN) deep brain stimulation (DBS) in early-stage Parkinson disease (PD) pilot clinical trial. METHODS The pilot was a prospective, single-blind clinical trial that randomized patients with early-stage PD (Hoehn & Yahr II off medications) to receive bilateral STN DBS plus optimal drug therapy (ODT) vs ODT alone (IDEG050016, NCT0282152, IRB040797). Participants who completed the 2-year trial participated in this observational follow-up study, which included annual outpatient visits through 5 years. This analysis includes 28 patients who were taking PD medications for 6 months to 4 years at enrollment. Outcomes were analyzed using both proportional odds logistic regression and linear mixed effects models. RESULTS Early STN DBS + ODT participants required lower levodopa equivalent daily doses ( p = 0.04, β = -240 mg, 95% confidence interval [CI] -471 to -8) and had 0.06 times the odds of requiring polypharmacy at 5 years compared to early ODT participants ( p = 0.01, odds ratio [OR] 0.06, 95% CI 0.00 to 0.65). The odds of having worse rest tremor for early STN DBS + ODT participants were 0.21 times those of early ODT participants ( p < 0.001, OR 0.21, 95% CI 0.09 to 0.45). The safety profile was similar between groups. CONCLUSIONS These results suggest that early DBS reduces the need for and complexity of PD medications while providing long-term motor benefit over standard medical therapy. Further investigation is warranted, and the Food and Drug Administration has approved the conduct of a prospective, multicenter, pivotal clinical trial of DBS in early-stage PD (IDEG050016). CLASSIFICATION OF EVIDENCE This study provides Class II evidence that DBS implanted in early-stage PD decreases the risk of disease progression and polypharmacy compared to optimal medical therapy alone.",2020,"RESULTS Early STN DBS+ODT subjects required lower levodopa equivalent daily doses (P=0.04, β = -240mg, 95%CI: -471 to -8) and had 0.06 times the odds of requiring polypharmacy at five years compared to early ODT subjects (P=0.01, OR=0.06, 95%CI: 0.00 to 0.65).","['Subjects who completed the two-year trial participated in this observational follow-up study which included annual outpatient visits through five years', ""Early-Stage Parkinson's Disease"", '28 subjects who were taking PD medications six months-four years at enrollment', ""early-stage Parkinson's disease (PD""]","['subthalmic nucleus (STN) deep brain stimulation (DBS', 'bilateral STN DBS plus optimal drug therapy (ODT) versus ODT']",['safety profile'],"[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}]","[{'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.127564,"RESULTS Early STN DBS+ODT subjects required lower levodopa equivalent daily doses (P=0.04, β = -240mg, 95%CI: -471 to -8) and had 0.06 times the odds of requiring polypharmacy at five years compared to early ODT subjects (P=0.01, OR=0.06, 95%CI: 0.00 to 0.65).","[{'ForeName': 'Mallory L', 'Initials': 'ML', 'LastName': 'Hacker', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD. Mallory.Hacker@vumc.org.'}, {'ForeName': 'Maxim', 'Initials': 'M', 'LastName': 'Turchan', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Heusinkveld', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.'}, {'ForeName': 'Amanda D', 'Initials': 'AD', 'LastName': 'Currie', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Millan', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Molinari', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.'}, {'ForeName': 'Peter E', 'Initials': 'PE', 'LastName': 'Konrad', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Davis', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.'}, {'ForeName': 'Fenna T', 'Initials': 'FT', 'LastName': 'Phibbs', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hedera', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Cannard', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Charles', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.'}]",Neurology,['10.1212/WNL.0000000000009946'] 737,32469406,Effect of the Timing of Antiretroviral Treatment Initiation on Outcomes in Children Living With Human Immunodeficiency Virus Admitted With Severe Acute Malnutrition.,"BACKGROUND Delays in early infant diagnosis and antiretroviral treatment (ART) initiation in developing countries frequently result in malnutrition at initial presentation with associated higher mortality and delayed immune recovery. The optimal timing of ART initiation is yet to be established. METHODS Eighty-two children admitted with HIV and severe acute malnutrition (SAM) between July 2012 and December 2015 were enrolled. Patients were randomized to initiate ART within 14 days from admission (early arm) or delay ART initiation until nutritional recovery and >14 days after admission (delayed arm). All patients received a standardized treatment and feeding protocol and were followed to 48 weeks. RESULTS The mean age of the patients at baseline was 23.3 months (standard deviation [SD], 27.9; range, 1.6-129 months). The mean time from admission to ART initiation was 5.6 days (SD, 4.4) in the early arm and 23 days (SD, 5.8) in the delayed arm (P < .001). There was no significant difference in mortality (P = .62), virologic response (P = .53), and anthropometric response (P = .57) between the 2 groups at 48 weeks. However, the rates of change in CD4, viral load, weight for age z score, and height for age z score occurred earlier and favored the delayed arm at early time points but were not significant at 24 and 48 months. CONCLUSIONS Despite initial improved responses in the delayed arm, lack of difference in outcome at 48 weeks supports a pragmatic approach with earlier ART initiation in children living with HIV admitted with SAM.In this randomised controlled study of ART initiation in children admitted with HIV and severe acute malnutrition (SAM), despite initial improved responses in the delayed arm, lack of difference in outcome at 48 weeks supports a pragmatic approach with earlier ART initiation in children living with HIV admitted with SAM. CLINICAL TRIALS REGISTRATION PACTR 21609001751384.",2021,"There was no significant difference in mortality (P = .62), virologic response (P = .53), and anthropometric response (P = .57) between the 2 groups at 48 weeks.","['children living with HIV admitted with SAM', 'Eighty-two children admitted with HIV and severe acute malnutrition (SAM) between July 2012 and December 2015 were enrolled', 'Children Living With', 'Human Immunodeficiency Virus Admitted With Severe Acute Malnutrition', 'children admitted with HIV and severe acute malnutrition (SAM', 'children living with HIV admitted with SAM.In']",['Antiretroviral Treatment Initiation'],"['mean time from admission to ART initiation', 'rates of change in CD4, viral load, weight for age z score, and height for age z score', 'virologic response', 'mortality', 'anthropometric response']","[{'cui': 'C0553288', 'cui_str': 'Lives with children'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",82.0,0.233894,"There was no significant difference in mortality (P = .62), virologic response (P = .53), and anthropometric response (P = .57) between the 2 groups at 48 weeks.","[{'ForeName': 'Moherndran', 'Initials': 'M', 'LastName': 'Archary', 'Affiliation': 'Paediatric Unit, King Edward VIII Hospital, Durban, South Africa.'}, {'ForeName': 'Benn', 'Initials': 'B', 'LastName': 'Sartorius', 'Affiliation': 'School of Nursing and Public Health, College of Health Sciences, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'La Russa', 'Affiliation': 'Department of Pediatrics, College of Physicians and Surgeons, Columbia University, New York, New York, USA.'}, {'ForeName': 'Thobekile', 'Initials': 'T', 'LastName': 'Sibaya', 'Affiliation': 'Department of Paediatrics and Child Health, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Micheal', 'Initials': 'M', 'LastName': 'Healy', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, Columbia University, New York, New York, USA.'}, {'ForeName': 'Raziya A', 'Initials': 'RA', 'LastName': 'Bobat', 'Affiliation': 'Paediatric Unit, King Edward VIII Hospital, Durban, South Africa.'}]",Journal of the Pediatric Infectious Diseases Society,['10.1093/jpids/piaa054'] 738,32580920,Clinical behavior of posterior fixed partial dentures with a biologically oriented preparation technique: A 5-year randomized controlled clinical trial.,"STATEMENT OF PROBLEM Evidence of the behavior of the periodontal tissues around anterior teeth restored with the biologically oriented preparation technique (BOPT) is available. However, outcomes of this technique in posterior teeth restored with fixed partial dentures (FPDs) are lacking. PURPOSE The purpose of this randomized controlled clinical trial was to evaluate the clinical, mechanical, and biological behavior of posterior 3-unit FPDs placed on teeth prepared with BOPT. MATERIAL AND METHODS Forty participants received a 3-unit zirconia FPD in the posterior region of the mandible or maxilla. Twenty FPDs were placed on teeth prepared with BOPT (study group) and 20 on teeth with a horizontal chamfer finishing line (control group). Follow-up examinations were performed 1, 3, and 5 years after treatment to evaluate periodontal responses around the prepared teeth by means of the following parameters: plaque index, gingival index, probing depth, and marginal stability (MS). Mechanical behavior was also assessed, as were any complications. RESULTS After the 5-year follow-up, 57.9% of the control group and 35% of the BOPT group presented a plaque index of 1. The gingival index was 1 in 68.4% of the control group and 30% of the BOPT group after the follow-up period. In the analysis of probing depth, 26.3% of teeth in the control group had pockets of more than 3 mm in depth, whereas the BOPT group had only 10%. Marginal stability appeared in 100% of the BOPT group, whereas only 10.5% of the control group exhibited gingival stability. Complications during the follow-up period were similar, 20% in the control group and 15% in the BOPT group. CONCLUSIONS Posterior FPDs prepared by using BOPT had a good clinical response over a 5-year follow-up, with a low gingival index, a small increase in pocket depth, and a 100% marginal stability of the surrounding tissues. High survival rates after 5 years indicated that the technique produced predictable outcomes.",2020,"Complications during the follow-up period were similar, 20% in the control group and 15% in the BOPT group. ","['Twenty FPDs were placed on teeth prepared with BOPT (study group) and 20 on teeth with a horizontal chamfer finishing line (control group', 'in the posterior region of the mandible or maxilla', 'Forty participants received a']","['Posterior FPDs', 'BOPT', 'posterior fixed partial dentures with a biologically oriented preparation technique', '3-unit zirconia FPD']","['Marginal stability', 'plaque index, gingival index, probing depth, and marginal stability (MS', 'gingival stability', 'Mechanical behavior', 'Complications', 'High survival rates', 'gingival index', 'plaque index']","[{'cui': 'C0011461', 'cui_str': 'Fixed Partial Denture'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0205460', 'cui_str': 'Biologic'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0011461', 'cui_str': 'Fixed Partial Denture'}, {'cui': 'C0205460', 'cui_str': 'Biologic'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}]","[{'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",20.0,0.0844149,"Complications during the follow-up period were similar, 20% in the control group and 15% in the BOPT group. ","[{'ForeName': 'Rubén', 'Initials': 'R', 'LastName': 'Agustín-Panadero', 'Affiliation': 'Adjunct Professor, Department of Stomatology, Faculty of Medicine and Dentistry, Valencia University, Spain.'}, {'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Serra-Pastor', 'Affiliation': 'Associate Professor, Department of Stomatology, Faculty of Medicine and Dentistry, Valencia University, Spain. Electronic address: blanca.serrapastor@gmail.com.'}, {'ForeName': 'Ignazio', 'Initials': 'I', 'LastName': 'Loi', 'Affiliation': 'Private practice, Cagliari, Italy.'}, {'ForeName': 'M Jesús', 'Initials': 'MJ', 'LastName': 'Suárez', 'Affiliation': 'Adjunct Professor, Department of Dental Prosthesis, Faculty of Dentistry, Complutense University, Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Pelaez', 'Affiliation': 'Associate Professor, Department of Dental Prosthesis, Faculty of Dentistry, Complutense University, Madrid, Spain.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Solá-Ruíz', 'Affiliation': 'Adjunct Professor, Department of Stomatology, Faculty of Medicine and Dentistry, Valencia University, Spain.'}]",The Journal of prosthetic dentistry,['10.1016/j.prosdent.2020.03.031'] 739,32482641,"Effects of enhanced STI partner notification counselling and provider-assisted partner services on partner referral and the incidence of STI diagnosis in Cape Town, South Africa: randomised controlled trial.","OBJECTIVES We investigated the effects of an enhanced partner notification (PN) counselling intervention with the offer of provider-assisted referral among people diagnosed with STI in a Cape Town public clinic. METHODS Participants were adults diagnosed with STI at a community clinic. After the standard STI consultation, participants were randomly allocated in a 1:1:1 ratio to (1) 'HE': 20 min health education; (2) 'RR': 45 min risk reduction skills counselling; or (3) 'ePN': 45 min enhanced partner notification communication skills counselling and the offer of provider-assisted referral. The primary outcome was the incidence of repeat STI diagnoses during the 12 months after recruitment, and the secondary outcome was participants' reports 2 weeks after diagnosis of notifying recent partners. Incidence rate ratios (IRRs) were used to compare the incidence rates between arms using a Poisson regression model. RESULTS The sample included 1050 participants, 350 per group, diagnosed with STI between June 2014 and August 2017. We reviewed 1048 (99%) participant records, and identified 136 repeat STI diagnoses in the ePN arm, 138 in the RR arm and 141 in the HE arm. There was no difference in the annual incidence of STI diagnosis between the ePN and HE arms (IRR: 1.0; 95% CI 0.7 to 1.3), or between the RR and HE arms (IRR: 0.9; 95% CI 0.7 to 1.2). There was a greater chance of a partner being notified in the ePN condition compared with the HE condition, 64.3% compared with 53.8%, but no difference between the RR and HE arms. CONCLUSIONS PN counselling and education with provider-assisted services has the potential to change the behaviour of people diagnosed with STIs, increasing the number of partners they notify by more than 10%. However, these changes in behaviour did not lead to a reduction of repeat STI diagnoses. TRIAL REGISTRATION NUMBER PACTR201606001682364.",2021,"CONCLUSIONS PN counselling and education with provider-assisted services has the potential to change the behaviour of people diagnosed with STIs, increasing the number of partners they notify by more than 10%.","['people diagnosed with STI in a Cape Town public clinic', 'Participants were adults diagnosed with STI at a community clinic', 'Cape Town, South Africa', 'The sample included 1050 participants, 350 per group, diagnosed with STI between June 2014 and August 2017', '1048 (99%) participant records, and identified 136 repeat STI diagnoses in the ePN arm, 138 in the RR arm and 141 in the HE arm']","['enhanced STI partner notification counselling and provider-assisted partner services', 'enhanced partner notification (PN) counselling intervention', ""HE': 20\u2009min health education; (2) 'RR': 45\u2009min risk reduction skills counselling; or (3) 'ePN': 45\u2009min enhanced partner notification communication skills counselling and the offer of provider-assisted referral""]","['annual incidence of STI diagnosis', 'incidence of repeat STI diagnoses', 'partner referral and the incidence of STI diagnosis', 'Incidence rate ratios (IRRs']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0587907', 'cui_str': 'Community clinic'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517528', 'cui_str': '1050'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0014614', 'cui_str': 'Ethyl nitrophenyl benzene thiophosphonate'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4517572', 'cui_str': '141'}]","[{'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0079990', 'cui_str': 'Partner Notification'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0014614', 'cui_str': 'Ethyl nitrophenyl benzene thiophosphonate'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}]","[{'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",1050.0,0.267624,"CONCLUSIONS PN counselling and education with provider-assisted services has the potential to change the behaviour of people diagnosed with STIs, increasing the number of partners they notify by more than 10%.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mathews', 'Affiliation': 'Health Systems Research Unit, South African Medical Research Council, Tygerberg, South Africa cathy.mathews@mrc.ac.za.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Lombard', 'Affiliation': 'Biostatistics Unit, South Africa Medical Research Council, Tygerberg, South Africa.'}, {'ForeName': 'Moira', 'Initials': 'M', 'LastName': 'Kalichman', 'Affiliation': 'Institute for Collaboration on Health, Intervention, and Policy, University of Connecticut, Storrs, Connecticut, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dewing', 'Affiliation': 'Health Systems Research Unit, South African Medical Research Council, Tygerberg, South Africa.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Banas', 'Affiliation': 'Health Systems Research Unit, South African Medical Research Council, Tygerberg, South Africa.'}, {'ForeName': 'Sekelwa', 'Initials': 'S', 'LastName': 'Dumile', 'Affiliation': 'Health Systems Research Unit, South African Medical Research Council, Tygerberg, South Africa.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Mdlikiva', 'Affiliation': 'Health Systems Research Unit, South African Medical Research Council, Tygerberg, South Africa.'}, {'ForeName': 'Thembinkosi', 'Initials': 'T', 'LastName': 'Mdlikiva', 'Affiliation': 'Health Systems Research Unit, South African Medical Research Council, Tygerberg, South Africa.'}, {'ForeName': 'Karen Ann', 'Initials': 'KA', 'LastName': 'Jennings', 'Affiliation': 'City Health Department of Cape Town Municipality, Cape Town, South Africa.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Daniels', 'Affiliation': 'City Health Department of Cape Town Municipality, Cape Town, South Africa.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Berteler', 'Affiliation': 'City of Cape Town IS&T Department, City of Cape Town, Cape Town, Western Cape, South Africa.'}, {'ForeName': 'Seth C', 'Initials': 'SC', 'LastName': 'Kalichman', 'Affiliation': 'Institute for Collaboration on Health, Intervention, and Policy, University of Connecticut, Storrs, Connecticut, USA.'}]",Sexually transmitted infections,['10.1136/sextrans-2020-054499'] 740,32482174,Using the axillary reverse mapping technique to screen breast cancer patients with a high risk of lymphedema.,"BACKGROUND Preventing breast cancer-related lymphedema (BCRL) by preserving upper lymphatic drainage is still controversial. Our study aimed to use the axillary reverse mapping (ARM) technique in patients who underwent axillary surgery to analyse the correlation between postoperative residual ARM nodes and the occurrence of lymphedema, select candidates at high risk of developing lymphedema, and analyse the oncologic safety of ARM nodes. METHODS Patients undergoing sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) from October 2015 to February 2016 at the Peking University People's Hospital Breast Center were prospectively recruited for the study. ARM was performed in all patients before surgery. ARM nodes were separated from SLNB and ALND specimens. Data were collected on the identification of ARM nodes before surgery, number of residual ARM nodes after surgery, nodal status, crossover rate, and correlation between residual ARM nodes and the occurrence of lymphedema. RESULTS The analysis included 78 patients. Of the 53 patients who underwent SLNB, crossover between ARM nodes and breast sentinel lymph nodes (SLNs) was seen in 22 specimens. The incidence of ARM node metastasis was 1.89% (1/53) and 25% (9/36) in the SLNB and ALND groups, respectively. The number of positive axillary lymph nodes was associated with the involvement of ARM nodes (P = 0.036). The incidence of residual ARM nodes was significantly higher in the SLNB group than in the ALND group (67.6% vs. 37.9%, P = 0.016). The incidence of lymphedema was significantly higher in the ALND group than in the SLNB group (33.3% vs. 5.4%, P = 0.003). CONCLUSIONS For SLNB, the ARM technique can help to resect SLNs more accurately. However, we do not recommend using the ARM technique to preserve ARM nodes in patients undergoing ALND due to oncologic safety issues. Nevertheless, we can predict patients undergoing axillary surgery who are more likely to have a high risk of lymphedema by assessing residual ARM nodes. TRIAL REGISTRATION This study was registered on ClinicalTrials.gov in February 2016. The clinical trial registration number is NCT02691624.",2020,The number of positive axillary lymph nodes was associated with the involvement of ARM nodes (P = 0.036).,"['patients undergoing axillary surgery who are more likely to have a high risk of lymphedema by assessing residual ARM nodes', '78 patients', ""Patients undergoing sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) from October 2015 to February 2016 at the Peking University People's Hospital Breast Center were prospectively recruited for the study"", 'patients who underwent axillary surgery', 'screen breast cancer patients with a high risk of lymphedema', '53 patients who underwent SLNB, crossover between ARM nodes and breast sentinel lymph nodes (SLNs) was seen in 22 specimens']","['ALND', 'axillary reverse mapping (ARM) technique', 'SLNB', 'axillary reverse mapping technique']","['number of positive axillary lymph nodes', 'incidence of lymphedema', 'incidence of residual ARM nodes', 'incidence of ARM node metastasis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0281182', 'cui_str': 'Screening for malignant neoplasm of breast'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0677944', 'cui_str': 'Sentinel node'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0729594', 'cui_str': 'Axillary lymph node group'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",,0.0594634,The number of positive axillary lymph nodes was associated with the involvement of ARM nodes (P = 0.036).,"[{'ForeName': 'Siyao', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Breast Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': ""Nuclear Medicine Department, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': ""Breast Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Houpu', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': ""Breast Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': ""Breast Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Siyuan', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Breast Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': ""Breast Center, Peking University People's Hospital, Beijing, China. liumiao@pkuph.edu.cn.""}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Breast Center, Peking University People's Hospital, Beijing, China. shuwang@pkuph.edu.cn.""}]",World journal of surgical oncology,['10.1186/s12957-020-01886-9'] 741,32585700,Long-term efficacy and tolerability of lemborexant compared with placebo in adults with insomnia disorder: results from the phase 3 randomized clinical trial SUNRISE 2.,"STUDY OBJECTIVES To assess long-term efficacy and safety of lemborexant (LEM), a novel dual orexin receptor antagonist, versus placebo in adults with insomnia disorder. METHODS This was a 12-month, global, multicenter, randomized, double-blind, parallel-group phase 3 study comprising a 6-month placebo-controlled period (reported here) followed by a 6-month active-treatment-only period (reported separately). A total of 949 participants with insomnia (age ≥18 years) were randomized, received treatment with an oral dose of placebo or LEM (5 mg [LEM5] or 10 mg [LEM10]) and were analyzed. Sleep onset and sleep maintenance endpoints were analyzed from daily electronic sleep diary data. Treatment-emergent adverse events (TEAEs) were monitored throughout the study. RESULTS Decreases from baseline in patient-reported (subjective) sleep onset latency and subjective wake after sleep onset, and increases from baseline in subjective sleep efficiency, were significantly greater with LEM5 and LEM10 versus placebo. Significant benefits over placebo were observed at the end of month 6, and at most time points assessed over the 6-month period, indicating long-term sustained efficacy of LEM. A significantly greater percentage of sleep onset responders and sleep maintenance responders were observed with LEM treatment versus placebo. Participants treated with LEM reported a significant improvement in quality of sleep after 6 months versus placebo. The majority of TEAEs were mild or moderate. There was a low rate of serious TEAEs and no deaths. CONCLUSIONS LEM5 and LEM10 provided significant benefit on sleep onset and sleep maintenance in individuals with insomnia disorder versus placebo, and was well tolerated. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, NCT02952820; ClinicalTrialsRegister.eu, EudraCT Number 2015-001463-39.",2020,"CONCLUSIONS LEM5 and LEM10 provided significant benefit on sleep onset and sleep maintenance in individuals with insomnia disorder versus placebo, and was well tolerated.","['949 participants with insomnia (age ≥18 years', 'adults with insomnia disorder', 'individuals with insomnia disorder versus']","['placebo or LEM (5 mg [LEM5] or 10 mg [LEM10', 'LEM', 'LEM5 and LEM10', 'lemborexant (LEM', 'lemborexant', 'placebo']","['quality of sleep', 'percentage of sleep onset responders and sleep maintenance responders', 'subjective sleep efficiency', 'sleep onset and sleep maintenance', 'tolerated', 'Sleep onset and sleep maintenance endpoints', 'low rate of serious TEAEs and no deaths']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",949.0,0.47688,"CONCLUSIONS LEM5 and LEM10 provided significant benefit on sleep onset and sleep maintenance in individuals with insomnia disorder versus placebo, and was well tolerated.","[{'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Kärppä', 'Affiliation': 'Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Yardley', 'Affiliation': 'Eisai Co., Ltd., Hatfield, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Pinner', 'Affiliation': 'Eisai Co., Ltd., Hatfield, UK.'}, {'ForeName': 'Gleb', 'Initials': 'G', 'LastName': 'Filippov', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Zammit', 'Affiliation': 'Clinilabs Drug Development Corporation, New York, NY.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Moline', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Perdomo', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Ishikawa', 'Affiliation': 'Eisai Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Kubota', 'Affiliation': 'Eisai Co., Ltd., Tokyo, Japan.'}]",Sleep,['10.1093/sleep/zsaa123'] 742,32483678,Treatment of avascular osteonecrosis of femoral head by core decompression and platelet-rich plasma: a prospective not controlled study.,"PURPOSE Core decompression is a surgical option since the 1960s for hip osteonecrosis treatment. This technique promotes bone repair by reducing intramedullary pressure, but this is not often enough to stop the progression of necrosis. The aim of this study was to associate core decompression with the regenerative stimulus provided by platelet-rich plasma (PRP) and compare our results with other regenerative techniques. METHODS Femoral head osteonecrosis was prospectively evaluated in 30 hips (22 patients, 15-60 years) treated by core decompression and PRP graft. Patients presented monolateral or bilateral osteonecrosis in stage I-IIA-IIB according to Arlet and Ficat classification. The outcome was assessed by changes in Harris Hip Score (HHS) and the need for total hip replacement (THA). RESULTS The mean preoperative HHS was 64 points, at two years from surgery was roughly 84 points. Sixteen of 30 hips showed osteonecrosis progression of the femoral head and were converted to THA. At the five year follow-up, the survival rate was 100% for patients at stage I, 67% for stage IIA, and 0% for stage IIB and was 68% and 32% for idiopathic and secondary osteonecrosis, respectively. CONCLUSION Core decompression combined with PRP could be indicated as a treatment for the I and IIA stages of osteonecrosis, as it significantly reduces joint pain and delays THA. This procedure should be avoided in AVNFH related to cortisone therapy because only a few benefits have been proven. It also has the advantage of being technically simple, minimally invasive, and free from complications.",2020,"At the five year follow-up, the survival rate was 100% for patients at stage I, 67% for stage IIA, and 0% for stage IIB and was 68% and 32% for idiopathic and secondary osteonecrosis, respectively. ","['avascular osteonecrosis of femoral head by core decompression and platelet-rich plasma', 'Femoral head osteonecrosis was prospectively evaluated in 30 hips (22 patients, 15-60\xa0years) treated by core decompression and PRP graft', 'Patients presented monolateral or bilateral osteonecrosis in stage I-IIA-IIB according to Arlet and Ficat classification']",['PRP'],"['Harris Hip Score (HHS) and the need for total hip replacement (THA', 'osteonecrosis progression', 'mean preoperative HHS', 'joint pain and delays THA', 'survival rate']","[{'cui': 'C0410480', 'cui_str': 'Avascular necrosis of the head of femur'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0015813', 'cui_str': 'Structure of head of femur'}, {'cui': 'C0029445', 'cui_str': 'Bone necrosis'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}]","[{'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0029445', 'cui_str': 'Bone necrosis'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.0353426,"At the five year follow-up, the survival rate was 100% for patients at stage I, 67% for stage IIA, and 0% for stage IIB and was 68% and 32% for idiopathic and secondary osteonecrosis, respectively. ","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Grassi', 'Affiliation': 'Clinical Orthopedics, Department of Clinical and Molecular Science, School of Medicine, Università Politecnica delle Marche, via Tronto 10/A, 60126, Torrette di Ancona, Italy. marco.grassi7@gmail.com.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Salari', 'Affiliation': 'Clinical Orthopedics, Department of Clinical and Molecular Science, School of Medicine, Università Politecnica delle Marche, via Tronto 10/A, 60126, Torrette di Ancona, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Massetti', 'Affiliation': 'Clinical Orthopedics, Department of Clinical and Molecular Science, School of Medicine, Università Politecnica delle Marche, via Tronto 10/A, 60126, Torrette di Ancona, Italy.'}, {'ForeName': 'Giuseppe F', 'Initials': 'GF', 'LastName': 'Papalia', 'Affiliation': 'Clinical Orthopedics, Department of Clinical and Molecular Science, School of Medicine, Università Politecnica delle Marche, via Tronto 10/A, 60126, Torrette di Ancona, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gigante', 'Affiliation': 'Clinical Orthopedics, Department of Clinical and Molecular Science, School of Medicine, Università Politecnica delle Marche, via Tronto 10/A, 60126, Torrette di Ancona, Italy.'}]",International orthopaedics,['10.1007/s00264-020-04628-4'] 743,32583297,The Role of Ursodeoxycholic Acid (UDCA) in Cholelithiasis Management After One Anastomosis Gastric Bypass (OAGB) for Morbid Obesity: Results of a Monocentric Randomized Controlled Trial.,"INTRODUCTION Bariatric surgery leads to rapid weight loss, a well-known risk factor for gallstone formation. Postoperative biliary complication rate requiring cholecystectomy is between 0.9 and 7.5% after laparoscopic sleeve gastrectomy and between 6 and 50% after laparoscopic gastric bypass. Several authors recommended ursodeoxycholic acid (UDCA) administration to reduce gallstone formation after diet-induced weight reduction. The aim of this randomized monocentric study is to evaluate gallstone incidence after prophylactic administration of UDCA in patients undergoing one anastomosis gastric bypass (OAGB). METHODS Patients undergoing OAGB were prospectively randomized into 2 groups: the UDCA group receiving oral UDCA 600 mg/days for 6 months in the immediate postoperative days, and the control group not administered with UDCA. Each group included 95 patients. Abdominal ultrasound, clinical evaluation, and quality of life scoring with Gastrointestinal Quality of Life Index (GIQLI) were performed postoperatively in all patients at 3, 6, and 12 months. RESULTS At 12 months of postoperative follow-up, 4 (4.2%) and 24 patients (25.2%) showed gallstones in the UDCA group and control group, respectively (p < 0.05). Among those who developed gallstones, 8 (28.6%) cases were symptomatic whereas 20 (71.4%) did not show any symptom. No statistically significant difference in GIQLI score between the two groups was found. CONCLUSION OAGB, as other malabsorbent procedures, appears to have higher rate of cholelithiasis than purely restrictive procedures. In our prospective randomized controlled study, a regular postoperative UDCA intake during the first 6 months seems to significantly reduce cholelithiasis incidence after OAGB, with no case of intolerance reported. Further studies are needed to assess this issue.",2020,"No statistically significant difference in GIQLI score between the two groups was found. ","['Cholelithiasis Management', 'Morbid Obesity', 'Patients undergoing OAGB', 'patients undergoing one anastomosis gastric bypass (OAGB']","['Anastomosis Gastric Bypass (OAGB', 'ursodeoxycholic acid (UDCA', 'laparoscopic sleeve gastrectomy', 'laparoscopic gastric bypass', 'Ursodeoxycholic Acid (UDCA', 'UDCA group receiving oral UDCA', 'UDCA', 'control group not administered with UDCA']","['gallstone incidence', 'gallstone formation', 'GIQLI score', 'Abdominal ultrasound, clinical evaluation, and quality of life scoring with Gastrointestinal Quality of Life Index (GIQLI', 'gallstones', 'Postoperative biliary complication rate requiring cholecystectomy']","[{'cui': 'C0008350', 'cui_str': 'Biliary calculus'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}]","[{'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}, {'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C4039248', 'cui_str': 'Laparoscopic bypass of stomach'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0008350', 'cui_str': 'Biliary calculus'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}]",,0.0262239,"No statistically significant difference in GIQLI score between the two groups was found. ","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Pizza', 'Affiliation': 'Department of Surgery, Hospital ""A. Rizzoli"", Lacco Ameno, Naples, Italy. Francesco_pizza@libero.it.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': ""D'Antonio"", 'Affiliation': 'Division of General and Emergency Surgery, AslNapoli2nord, Frattamaggiore, Naples, Italy.'}, {'ForeName': 'Francesco Saverio', 'Initials': 'FS', 'LastName': 'Lucido', 'Affiliation': 'Division of General, Mininvasive and Bariatric Surgery, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Tolone', 'Affiliation': 'Division of General, Mininvasive and Bariatric Surgery, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Gianmattia', 'Initials': 'G', 'LastName': 'Del Genio', 'Affiliation': 'Division of General, Mininvasive and Bariatric Surgery, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': ""Dell'Isola"", 'Affiliation': 'Department of Infectious Diseases, AORN ""Dei Colli"" Naples, Naples, Italy.'}, {'ForeName': 'Ludovico', 'Initials': 'L', 'LastName': 'Docimo', 'Affiliation': 'Division of General, Mininvasive and Bariatric Surgery, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Gambardella', 'Affiliation': 'Division of General, Mininvasive and Bariatric Surgery, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}]",Obesity surgery,['10.1007/s11695-020-04801-z'] 744,32583298,Impact of Routine and Long-Term Follow-Up on Weight Loss after Bariatric Surgery.,"BACKGROUND Weight loss after bariatric surgery varies among patients. Patients who do not complete long-term follow-up are considered to loose less weight than those with regular follow-up visits. OBJECTIVE To evaluate the influence of patients' follow-up compliance on long-term excess weight loss (%EWL) and total weight loss (%TWL) after bariatric surgery, comparing results between gastric bypass (GB) and sleeve gastrectomy (SG). METHODS Patients with up to 5 years of follow-up data after bariatric surgery were included in this retrospective analysis. Patients were divided in 2 groups: those in group 1 who had attended every scheduled postoperative appointment and those in group 2 who had been lost to follow-up before 1 year and were later contacted by telephone. %EWL and %TWL were compared to determine the possible relationship between type of surgery and regularity of the follow-up. RESULTS A total of 385 patients were included. A significant difference in EWL was observed at 5 years in the SG group (78% for group 1 versus 39% for group 2; p = 0.02) and GB group (75% for group 1 versus 62% for group 2; p = 0.01). No significant differences between surgeries were found when comparing long-term EWL in group 1 patients 77% for SG versus 75% for GB. For group 2 patients, GB achieved greater EWL than SG; p = 0.005. %TWL patients in group 2 showed significant differences in all periods of study (p < 0.05). CONCLUSION Bariatric surgery patients who attended all scheduled follow-up appointments experienced significantly greater long-term EWL and TWL than those who did not. GB has apparent increased benefits for weight loss in long-term follow-up when compared with SG for patients who did not attend long-term follow-up. Therefore, continued long-term follow-up of bariatric patients should be encouraged to increase postoperative weight loss results.",2020,No significant differences between surgeries were found when comparing long-term EWL in group 1 patients 77% for SG versus 75% for GB.,"['Patients were divided in 2 groups: those in group 1 who had attended every scheduled postoperative appointment and those in group 2 who had been lost to follow-up before 1\xa0year and were later contacted by telephone', 'A total of 385 patients were included', 'Patients with up to 5\xa0years of follow-up data after bariatric surgery', 'patients', 'after Bariatric Surgery', 'Patients who do not complete long-term follow-up are considered to loose less weight than those with regular follow-up visits']","['gastric bypass (GB) and sleeve gastrectomy (SG', 'GB', 'Routine and Long-Term Follow-Up']","['total weight loss', 'weight loss', 'EWL', 'Weight Loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517751', 'cui_str': '385'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205407', 'cui_str': 'Loose'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}]","[{'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",385.0,0.0227792,No significant differences between surgeries were found when comparing long-term EWL in group 1 patients 77% for SG versus 75% for GB.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lujan', 'Affiliation': 'Department General Surgery, Bariatric and Metabolic Surgery, Clínica Universidad de Navarra, Avenida Pio XII 36, 31008, Pamplona, Navarra, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Tuero', 'Affiliation': 'Department General Surgery, Bariatric and Metabolic Surgery, Clínica Universidad de Navarra, Avenida Pio XII 36, 31008, Pamplona, Navarra, Spain.'}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Landecho', 'Affiliation': 'Department of Internal Medicine, Clínica Universidad de Navarra, Pamplona, Navarra, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Moncada', 'Affiliation': 'Department of Anesthesiology, Clínica Universidad de Navarra, Pamplona, Navarra, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'A Cienfuegos', 'Affiliation': 'Department General Surgery, Bariatric and Metabolic Surgery, Clínica Universidad de Navarra, Avenida Pio XII 36, 31008, Pamplona, Navarra, Spain.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Rotellar', 'Affiliation': 'Department General Surgery, Bariatric and Metabolic Surgery, Clínica Universidad de Navarra, Avenida Pio XII 36, 31008, Pamplona, Navarra, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Silva', 'Affiliation': 'Department of Endocrinology, Clínica Universidad de Navarra, Pamplona, Navarra, Spain.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Lapuente', 'Affiliation': 'Department General Surgery, Bariatric and Metabolic Surgery, Clínica Universidad de Navarra, Avenida Pio XII 36, 31008, Pamplona, Navarra, Spain.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Martínez', 'Affiliation': 'Department General Surgery, Bariatric and Metabolic Surgery, Clínica Universidad de Navarra, Avenida Pio XII 36, 31008, Pamplona, Navarra, Spain.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Frühbeck', 'Affiliation': 'Department of Endocrinology, Clínica Universidad de Navarra, Pamplona, Navarra, Spain.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Valenti', 'Affiliation': 'Department General Surgery, Bariatric and Metabolic Surgery, Clínica Universidad de Navarra, Avenida Pio XII 36, 31008, Pamplona, Navarra, Spain. vvalenti@unav.es.'}]",Obesity surgery,['10.1007/s11695-020-04788-7'] 745,32583300,A Comprehensive Approach for the Prevention of Nausea and Vomiting Following Sleeve Gastrectomy: a Randomized Controlled Trial.,"BACKGROUND Postoperative nausea and vomiting (PONV) following sleeve gastrectomy (SG) is a common occurrence. The effect of specific interventions in PONV prevention within enhanced recovery pathways remains unclear. The aim of this study was to evaluate the impact of a comprehensive approach for the prevention of PONV on patient outcomes and hospital resource utilization. METHODS A prospective randomized trial was conducted for patients undergoing SG. The intervention group received aprepitant and transdermal scopolamine preoperatively followed by ondansetron and dexamethasone intraoperatively, with total intravenous anesthesia. The control group received inhalational anesthetic and two intraoperative antiemetics without preoperative prophylaxis. The primary endpoint was a PONV-related delay in hospital discharge. RESULTS Eighty-three patients completed the study (41 in the intervention and 42 in the control group). Eighty-nine percent of patients were discharged home on the first postoperative day. Four patients in the control group and none in the intervention group experienced a PONV-related delay in discharge (9.5% vs 0, p = 0.119). Intervention patients reported significantly lower PONV scores at all in-hospital time points examined (p = 0.0392 for verbal scores and p < 0.0001 for Rhodes Index) and significantly higher self-rated quality of recovery at 24 h (Quality of Recovery-15 instrument, p < 0.05). CONCLUSIONS A multilevel approach to PONV leads to significantly lower severity of PONV and improved self-reported quality of recovery, compared with control. PONV-related readmissions, ED visits, and discharge delays were uncommon within the overall enhanced recovery cohort.",2020,"Intervention patients reported significantly lower PONV scores at all in-hospital time points examined (p = 0.0392 for verbal scores and p < 0.0001 for Rhodes Index) and significantly higher self-rated quality of recovery at 24 h (Quality of Recovery-15 instrument, p < 0.05). ","['patients undergoing SG', 'Eighty-three patients completed the study (41 in the intervention and 42 in the control group']","['aprepitant and transdermal scopolamine preoperatively followed by ondansetron and dexamethasone', 'Sleeve Gastrectomy', 'sleeve gastrectomy (SG', 'inhalational anesthetic and two intraoperative antiemetics without preoperative prophylaxis']","['PONV-related readmissions, ED visits, and discharge delays', 'Nausea and Vomiting', 'PONV-related delay in discharge', 'PONV scores', 'self-rated quality of recovery', 'PONV-related delay in hospital discharge']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0036442', 'cui_str': 'Scopolamine'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",,0.127697,"Intervention patients reported significantly lower PONV scores at all in-hospital time points examined (p = 0.0392 for verbal scores and p < 0.0001 for Rhodes Index) and significantly higher self-rated quality of recovery at 24 h (Quality of Recovery-15 instrument, p < 0.05). ","[{'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Spaniolas', 'Affiliation': 'Department of Surgery, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, 11794, USA. konstantinos.spaniolas@stonybrookmedicine.edu.'}, {'ForeName': 'Lizhou', 'Initials': 'L', 'LastName': 'Nie', 'Affiliation': 'Department of Family, Population & Preventive Medicine, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'Daryn', 'Initials': 'D', 'LastName': 'Moller', 'Affiliation': 'Department of Anesthesiology, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'Talar', 'Initials': 'T', 'LastName': 'Tatarian', 'Affiliation': 'Department of Surgery, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Hesketh', 'Affiliation': 'Department of Surgery, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Family, Population & Preventive Medicine, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Docimo', 'Affiliation': 'Department of Surgery, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bates', 'Affiliation': 'Department of Surgery, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'Tong J', 'Initials': 'TJ', 'LastName': 'Gan', 'Affiliation': 'Department of Anesthesiology, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Pryor', 'Affiliation': 'Department of Surgery, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, 11794, USA.'}]",Obesity surgery,['10.1007/s11695-020-04795-8'] 746,32594370,Efficacy of low or standard rituximab-based protocols and comparison to Ponticelli's regimen in membranous nephropathy.,"BACKGROUND Patients (pts) with primary Membranous nephropathy (MN) have an autoimmune disease caused by autoantibodies against podocyte antigens and 60-80% of them have antibodies directed against the M-type phospholipase A2 receptor (PLA2R). Immunosuppressive treatment is recommended in high-medium risk pts. Recently the use of rituximab (RTX), has emerged as an important therapeutic option in pts with primary MN. The appropriate cumulative dose of RTX in PMN pts is still uncertain, and favorable outcomes even with low-dose of RTX has been described. We compared efficacy and safety of 3 different treatment regimens: low-dose RTX (Protocol 1, one dose of RTX 375 mg/m 2 ), standard RTX protocol (Protocol 2, four weekly doses of rituximab 375 mg/m 2 ) and Ponticelli's regimen. METHODS 42 pts with primary MN and nephrotic syndrome were assigned to Protocol 1 (14 pts) or Protocol 2 (14 pts). All patients were followed for 24 months after RTX. Fourteen pts, matched for age and baseline serum creatinine (sCr) and proteinuria, treated with Ponticelli's regimen were examined as controls. RESULTS At 24 months, a significant improvement in proteinuria levels was observed in pts treated with Protocol 1 (7.5 ± 4.8 at T0; 0.21 ± 0.15 at T24, p < 0.01), Protocol 2 (5.1 ± 1.41 g/24 at T0; 0.35 ± 0.39 at T24 p < 0.01) and controls (8.27 ± 4.78 T0; 2.2 ± 1.9 g/24 h at T24, p < 0.01). No differences in clinical response (p = 0.53) was observed comparing the 3 groups. CONCLUSIONS Our data suggest that the RTX is a promising alternative to Ponticelli's regimen even at low-doses. This makes RTX a cost-effective treatment of primary MN in the short and medium terms.",2021,"No differences in clinical response (p = 0.53) was observed comparing the 3 groups. ","['pts with primary MN', '42 pts with primary MN and nephrotic syndrome', 'membranous nephropathy', ""Fourteen pts, matched for age and baseline serum creatinine (sCr) and proteinuria, treated with Ponticelli's regimen were examined as controls"", 'Patients (pts) with primary Membranous nephropathy (MN']","[""low or standard rituximab-based protocols and comparison to Ponticelli's regimen"", ""rituximab 375\xa0mg/m 2 ) and Ponticelli's regimen"", 'rituximab (RTX', 'RTX', 'Immunosuppressive treatment']","['efficacy and safety', 'clinical response', 'proteinuria levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0017665', 'cui_str': 'Membranous glomerulonephritis'}, {'cui': 'C0027726', 'cui_str': 'Nephrotic syndrome'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0323735,"No differences in clinical response (p = 0.53) was observed comparing the 3 groups. ","[{'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Fenoglio', 'Affiliation': 'CMID-Nephrology and Dialysis Unit (ERK-Net Member), Coordinating Center of the Network for Rare Diseases of Piedmont and Aosta Valley, University of Turin and San Giovanni Bosco Hospital, Piazza del Donatore di Sangue 3, 10054, Turin, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Baldovino', 'Affiliation': 'CMID-Nephrology and Dialysis Unit (ERK-Net Member), Coordinating Center of the Network for Rare Diseases of Piedmont and Aosta Valley, University of Turin and San Giovanni Bosco Hospital, Piazza del Donatore di Sangue 3, 10054, Turin, Italy.'}, {'ForeName': 'Savino', 'Initials': 'S', 'LastName': 'Sciascia', 'Affiliation': 'CMID-Nephrology and Dialysis Unit (ERK-Net Member), Coordinating Center of the Network for Rare Diseases of Piedmont and Aosta Valley, University of Turin and San Giovanni Bosco Hospital, Piazza del Donatore di Sangue 3, 10054, Turin, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'De Simone', 'Affiliation': 'CMID-Nephrology and Dialysis Unit (ERK-Net Member), Coordinating Center of the Network for Rare Diseases of Piedmont and Aosta Valley, University of Turin and San Giovanni Bosco Hospital, Piazza del Donatore di Sangue 3, 10054, Turin, Italy.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Del Vecchio', 'Affiliation': 'CMID-Nephrology and Dialysis Unit (ERK-Net Member), Coordinating Center of the Network for Rare Diseases of Piedmont and Aosta Valley, University of Turin and San Giovanni Bosco Hospital, Piazza del Donatore di Sangue 3, 10054, Turin, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Ferro', 'Affiliation': 'CMID-Nephrology and Dialysis Unit (ERK-Net Member), Coordinating Center of the Network for Rare Diseases of Piedmont and Aosta Valley, University of Turin and San Giovanni Bosco Hospital, Piazza del Donatore di Sangue 3, 10054, Turin, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Quattrocchio', 'Affiliation': 'CMID-Nephrology and Dialysis Unit (ERK-Net Member), Coordinating Center of the Network for Rare Diseases of Piedmont and Aosta Valley, University of Turin and San Giovanni Bosco Hospital, Piazza del Donatore di Sangue 3, 10054, Turin, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Naretto', 'Affiliation': 'CMID-Nephrology and Dialysis Unit (ERK-Net Member), Coordinating Center of the Network for Rare Diseases of Piedmont and Aosta Valley, University of Turin and San Giovanni Bosco Hospital, Piazza del Donatore di Sangue 3, 10054, Turin, Italy.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Roccatello', 'Affiliation': 'CMID-Nephrology and Dialysis Unit (ERK-Net Member), Coordinating Center of the Network for Rare Diseases of Piedmont and Aosta Valley, University of Turin and San Giovanni Bosco Hospital, Piazza del Donatore di Sangue 3, 10054, Turin, Italy. dario.roccatello@unito.it.'}]",Journal of nephrology,['10.1007/s40620-020-00781-6'] 747,32613229,The iCanCope pain self-management application for adolescents with juvenile idiopathic arthritis: a pilot randomized controlled trial.,"OBJECTIVES To evaluate the feasibility and preliminary effectiveness of iCanCope with Pain (iCanCope), a smartphone-based pain self-management program, in adolescents with JIA. iCanCope featured symptom tracking, goal-setting, pain coping skills and social support. METHODS A two-arm pilot randomized controlled trial was used to evaluate the iCanCope app compared with a version with symptom tracking only. Primary (feasibility) outcomes were: participant accrual/attrition rates, success of app deployment, acceptability and adherence. Secondary (preliminary effectiveness) outcomes were: pain intensity, pain-related activity limitations and health-related quality of life. Outcomes were assessed at baseline and 8 weeks. Adherence was defined as the proportion of completed symptom reports: 'low' (≤24%); 'low-moderate' (25-49%); 'high-moderate' (50-75%); or 'high' (76-100%). Linear mixed models were applied for preliminary effectiveness analyses as per intention-to-treat. RESULTS Adolescents (N = 60) were recruited from three paediatric rheumatology centres. Rates of accrual and attrition were 82 and 13%, respectively. Both apps were deployed with high success (over 85%) and were rated as highly acceptable. Adherence was similar for both groups, with most participants demonstrating moderate-to-high adherence. Both groups exhibited a clinically meaningful reduction in pain intensity (≥1 point) that did not statistically differ between groups. There were no significant changes in activity limitations or health-related quality of life. CONCLUSION The iCanCope pilot randomized controlled trial was feasible to implement in a paediatric rheumatology setting. Both apps were deployed successfully, with high acceptability, and were associated with moderate-to-high adherence. Preliminary reductions in pain intensity warrant a future trial to evaluate effectiveness of iCanCope in improving health outcomes in adolescents with JIA. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT02764346.",2021,"There were no significant changes in activity limitations or health-related quality of life. ","['Adolescents (N\u2009=\u200960) were recruited from three paediatric rheumatology centres', 'adolescents with JIA', 'adolescents with juvenile idiopathic arthritis']","['iCanCope pain self-management application', 'iCanCope with Pain (iCanCope', 'smartphone-based pain self-management program', 'iCanCope']","['pain intensity, pain-related activity limitations and health-related quality of life', 'iCanCope featured symptom tracking, goal-setting, pain coping skills and social support', 'Rates of accrual and attrition', 'pain intensity', 'participant accrual/attrition rates, success of app deployment, acceptability and adherence', 'health outcomes', 'activity limitations or health-related quality of life', 'Adherence']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1621271', 'cui_str': 'Pediatric rheumatology'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C3495559', 'cui_str': 'Juvenile chronic arthritis'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.197165,"There were no significant changes in activity limitations or health-related quality of life. ","[{'ForeName': 'Chitra', 'Initials': 'C', 'LastName': 'Lalloo', 'Affiliation': 'Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Harris', 'Affiliation': 'Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario.'}, {'ForeName': 'Amos S', 'Initials': 'AS', 'LastName': 'Hundert', 'Affiliation': 'Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Berard', 'Affiliation': ""Division of Rheumatology, Children's Hospital London Health Sciences Centre, London, Ontario.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Cafazzo', 'Affiliation': 'Institute of Health Policy, Management & Evaluation, University of Toronto, Toronto, Ontario.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Connelly', 'Affiliation': ""Division of Developmental and Behavioural Health, Children's Mercy Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Feldman', 'Affiliation': 'Division of Rheumatology, The Hospital for Sick Children, Toronto, Ontario.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Houghton', 'Affiliation': ""Division of Rheumatology, BC Children's Hospital, Vancouver, British Columbia.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Huber', 'Affiliation': 'Division of Rheumatology, IWK Health Centre, Halifax, Nova Scotia.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Laxer', 'Affiliation': 'Division of Rheumatology, The Hospital for Sick Children, Toronto, Ontario.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Luca', 'Affiliation': ""Section of Pediatric Rheumatology, Alberta Children's Hospital, Calgary, Alberta.""}, {'ForeName': 'Heinrike', 'Initials': 'H', 'LastName': 'Schmeling', 'Affiliation': ""Section of Pediatric Rheumatology, Alberta Children's Hospital, Calgary, Alberta.""}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Spiegel', 'Affiliation': 'Division of Rheumatology, The Hospital for Sick Children, Toronto, Ontario.'}, {'ForeName': 'Lori B', 'Initials': 'LB', 'LastName': 'Tucker', 'Affiliation': ""Division of Rheumatology, BC Children's Hospital, Vancouver, British Columbia.""}, {'ForeName': 'Quynh', 'Initials': 'Q', 'LastName': 'Pham', 'Affiliation': 'Institute of Health Policy, Management & Evaluation, University of Toronto, Toronto, Ontario.'}, {'ForeName': 'Cleo C', 'Initials': 'CC', 'LastName': 'Davies-Chalmers', 'Affiliation': 'Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario.'}, {'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Stinson', 'Affiliation': 'Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa178'] 748,32581042,Serum interleukin-6 and C-reactive protein are associated with survival in melanoma patients receiving immune checkpoint inhibition.,"BACKGROUND Inflammatory mediators, including acute phase reactants and cytokines, have been reported to be associated with clinical efficacy in patients with melanoma and other cancers receiving immune checkpoint inhibitors (ICI). Analyses of patient sera from three large phase II/III randomized ICI trials, one of which included a chemotherapy arm, were performed to assess whether baseline levels of C-reactive protein (CRP), interleukin-6 (IL-6) or neutrophil/lymphocyte (N/L) ratios were prognostic or predictive. PATIENTS AND METHODS Baseline and on-treatment sera were analyzed by multiplex protein assays from immunotherapy-naïve patients with metastatic melanoma randomized 1:1 on the Checkmate-064 phase II trial of sequential administration of nivolumab followed by ipilimumab or the reverse sequence. Baseline sera, and peripheral blood mononuclear cells using automated cell counting, were analyzed from treatment-naïve patients who were BRAF wild-type and randomly allocated 1:1 to receive nivolumab or dacarbazine on the phase III Checkmate-066 trial, and from treatment-naïve patients allocated 1:1:1 to receive nivolumab, ipilimumab or both ipilimumab and nivolumab on the phase III Checkmate-067 trial. RESULTS Higher baseline levels of IL-6 and the N/L ratio, and to a lesser degree, CRP were associated with shorter survival in patients receiving ICI or chemotherapy. Increased on-treatment levels of IL-6 in patients on the Checkmate-064 study were also associated with shorter survival. IL-6 levels from patients on Checkmate-064, Checkmate-066 and Checkmate-067 were highly correlated with levels of CRP and the N/L ratio. CONCLUSION IL-6, CRP and the N/L ratio are prognostic factors with higher levels associated with shorter overall survival in patients with metastatic melanoma receiving ICI or chemotherapy in large randomized trials. In a multi-variable analysis of the randomized phase III Checkmate-067 study, IL-6 was a significant prognostic factor for survival.",2020,"RESULTS Higher baseline levels of IL-6 and the N/L ratio, and to a lesser degree, CRP were associated with shorter survival in patients receiving ICI or chemotherapy.","['melanoma patients receiving immune checkpoint inhibition', 'Baseline and on-treatment sera were analyzed by multiplex protein assays from immunotherapy-naïve patients with metastatic melanoma randomized 1:1 on the Checkmate-064 phase II trial of sequential administration of', 'patients with metastatic melanoma receiving', 'patients with melanoma and other cancers receiving immune checkpoint inhibitors (ICI', 'naïve patients who were BRAF wild-type']","['nivolumab, ipilimumab or both ipilimumab and nivolumab', 'nivolumab followed by ipilimumab', 'nivolumab or dacarbazine', 'ICI or chemotherapy']","['baseline levels of C-reactive protein (CRP), interleukin-6 (IL-6) or neutrophil/lymphocyte (N/L) ratios', 'IL-6 levels', 'overall survival', 'IL-6', 'shorter survival']","[{'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]",,0.152016,"RESULTS Higher baseline levels of IL-6 and the N/L ratio, and to a lesser degree, CRP were associated with shorter survival in patients receiving ICI or chemotherapy.","[{'ForeName': 'Andressa S', 'Initials': 'AS', 'LastName': 'Laino', 'Affiliation': 'Perlmutter Cancer Center, NYU Langone Health, New York, New York, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Woods', 'Affiliation': 'Department of Medicine, University of Colorado Denver-Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Vassallo', 'Affiliation': 'Perlmutter Cancer Center, NYU Langone Health, New York, New York, USA.'}, {'ForeName': 'Xiaozhong', 'Initials': 'X', 'LastName': 'Qian', 'Affiliation': 'Bristol-Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': 'Bristol-Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Wind-Rotolo', 'Affiliation': 'Bristol-Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Weber', 'Affiliation': 'Perlmutter Cancer Center, NYU Langone Health, New York, New York, USA Jeffrey.Weber@nyulangone.org.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2020-000842'] 749,32592481,Early Combined Immunosuppression May Be More Effective for Reducing Complications in Isolated Colonic- vs Ileal-Dominant Crohn Disease.,"BACKGROUND We assessed whether differential efficacy of early combined immunosuppression (ECI) in comparison with conventional management (CM) is present in patients with Crohn disease (CD) according to disease location. METHODS In this posthoc analysis of the Randomized Evaluation of an Algorithm for Crohn's Treatment trial, the effect of ECI vs CM modified by disease location (isolated-colonic vs ileal-dominant) in terms of time to first complication (hospitalization, surgery, or disease-related complications-presence of a new abscess, fistula, or stricture; serious worsening of disease activity; extraintestinal manifestations) was analyzed using a marginal Cox proportional hazard model to account for cluster randomization. Factors adjusted included practice size, country, and other covariates selected in a backward logistic regression analysis with the first composition as outcome and P < 0.10. RESULTS Of the 1969 patients with CD, 435 had isolated colonic CD (ECI n = 257, CM n = 178) and 1534 had ileal CD (ECI n = 817, CM n = 717). Over 24 months there was a significant differential impact for ECI vs CM for reducing the risk of a CD-related complication between patients with colonic CD and ileal CD (colonic CD hazard ratio [HR] = 0.51; 95% CI, 0.30-0.85 vs ileal CD HR = 0.79; 95% CI, 0.57-1.10; P = 0.033). No difference was identified between ECI vs CM for reducing the risk of surgery (colonic HR = 0.52 vs ileal HR = 0.74; P = 0.468) or hospitalization (colonic HR = 0.77 vs ileal HR = 0.83; P = 0.806). CONCLUSIONS In this posthoc analysis of the Randomized Evaluation of an Algorithm for Crohn's Treatment trial, symptom-based ECI was associated with greater efficacy for reducing the risk of CD-related complications in patients with colonic disease location relative to ileal disease location.",2021,No difference was identified between ECI vs CM for reducing the risk of surgery (colonic HR = 0.52,"['1969 patients with CD, 435 had isolated colonic CD (ECI n = 257, CM n = 178) and 1534 had ileal CD (ECI n = 817, CM n = 717', 'patients with colonic disease location relative to ileal disease location', 'patients with Crohn disease (CD) according to disease location']","['ECI', 'conventional management (CM', 'Immunosuppression', 'early combined immunosuppression (ECI']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0020885', 'cui_str': 'Ileal structure'}, {'cui': 'C0009373', 'cui_str': 'Disorder of colon'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0020875', 'cui_str': 'Ileal Diseases'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",[],,0.071335,No difference was identified between ECI vs CM for reducing the risk of surgery (colonic HR = 0.52,"[{'ForeName': 'Parambir S', 'Initials': 'PS', 'LastName': 'Dulai', 'Affiliation': 'Division of Gastroenterology, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Vipul', 'Initials': 'V', 'LastName': 'Jairath', 'Affiliation': 'Robarts Clinical Trials Inc, London, Ontario, Canada.'}, {'ForeName': 'Guangyong', 'Initials': 'G', 'LastName': 'Zou', 'Affiliation': 'Robarts Clinical Trials Inc, London, Ontario, Canada.'}, {'ForeName': 'Larry W', 'Initials': 'LW', 'LastName': 'Stitt', 'Affiliation': 'Robarts Clinical Trials Inc, London, Ontario, Canada.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Khanna', 'Affiliation': 'Robarts Clinical Trials Inc, London, Ontario, Canada.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'Division of Gastroenterology, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Feagan', 'Affiliation': 'Robarts Clinical Trials Inc, London, Ontario, Canada.'}, {'ForeName': 'Siddharth', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Division of Gastroenterology, University of California San Diego, La Jolla, California.'}]",Inflammatory bowel diseases,['10.1093/ibd/izaa168'] 750,32601665,Implementation of health education interventions at Dutch music schools.,"A randomized controlled trial was conducted comparing the effects of a biopsychosocial course (PRESTO-Play) vs. physical activity promotion (PRESTO-Fit) to reduce disability related to musculoskeletal disorders in music students. The current study provides an external validation and a formative and process evaluation, allowing for a better interpretation of results. First, a group of experts was asked to complete a structured evaluation of design and content of the trial. Second, quantitative and qualitative data were analysed from different stakeholders (students, therapists and conservatory staff) using questionnaires, logs, field notes and emails to evaluate fidelity, dose delivered, dose received, reach and context. Results are presented descriptively. Two authors independently identified key responses that were merged into themes. Although no difference in disability was found between interventions, closer evaluation revealed that participants in PRESTO-Play reported that they learned about prevention of physical complaints and were more satisfied with course contents compared with PRESTO-Fit. Study design and contents of the interventions were found to be valid, with an appropriate dose delivered. Feedback from students and logs suggested that behavioural change and psychosocial principles in PRESTO-Play might have not been implemented optimally. Only moderate fidelity in both groups and too little contrast between interventions could have influenced results. Low attendance rates and a presumed lack of generalization further decreased possible effectiveness. Context greatly influenced implementation. Implementing a future health course with closer collaboration with the institution could optimize accessibility and communication, encourage attendance and enhance motivation for behavioural change.",2021,"Although no difference in disability was found between interventions, closer evaluation revealed that participants in PRESTO-Play reported that they learned about prevention of physical complaints and were more satisfied with course contents compared with PRESTO-Fit.","['Dutch music schools', 'music students']","['biopsychosocial course (PRESTO-Play) vs. physical activity promotion (PRESTO-Fit', 'health education interventions']","['Low attendance rates', 'disability']","[{'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",2.0,0.0518353,"Although no difference in disability was found between interventions, closer evaluation revealed that participants in PRESTO-Play reported that they learned about prevention of physical complaints and were more satisfied with course contents compared with PRESTO-Fit.","[{'ForeName': 'Vera A E', 'Initials': 'VAE', 'LastName': 'Baadjou', 'Affiliation': 'Department of Rehabilitation Medicine, Adelante Centre of Expertise in Rehabilitation and Audiology, zandbergsweg 111, 6432 CC, Hoensbroek, The Netherlands.'}, {'ForeName': 'Bronwen J', 'Initials': 'BJ', 'LastName': 'Ackermann', 'Affiliation': 'Discipline of Biomedical Science, School of Medical Sciences, Sydney University, Sydney, Australia.'}, {'ForeName': 'Jeanine A M C F', 'Initials': 'JAMCF', 'LastName': 'Verbunt', 'Affiliation': 'Department of Rehabilitation Medicine, Adelante Centre of Expertise in Rehabilitation and Audiology, zandbergsweg 111, 6432 CC, Hoensbroek, The Netherlands.'}, {'ForeName': 'Marjon D F', 'Initials': 'MDF', 'LastName': 'van Eijsden-Besseling', 'Affiliation': 'Department of Rehabilitation Medicine, Care and Public Health Research Institute, Maastricht University, Universiteitssingel 40, 6229 ER, Postal Box 616, 6200 Maastricht, The Netherlands.'}, {'ForeName': 'Rob A', 'Initials': 'RA', 'LastName': 'de Bie', 'Affiliation': 'Department of Epidemiology, Musculoskeletal Group, Care And Public Health Research Institute, Maastricht University, Universiteitssingel 40, 6229 ER, Postal Box 616, 6200 Maastricht, The Netherlands.'}, {'ForeName': 'Rob J E M', 'Initials': 'RJEM', 'LastName': 'Smeets', 'Affiliation': 'Department of Rehabilitation Medicine, Care and Public Health Research Institute, Maastricht University, Universiteitssingel 40, 6229 ER, Postal Box 616, 6200 Maastricht, The Netherlands.'}]",Health promotion international,['10.1093/heapro/daaa050'] 751,32601670,Development of a Novel Mind-Body Activity and Pain Management Program for Older Adults With Cognitive Decline.,"BACKGROUND AND OBJECTIVES Chronic pain (CP) and cognitive decline (CD) often co-occur in older adults, which can reinforce a ""disability spiral."" Early interventions teaching pain coping skills and gradual increases in activity (walking) are needed to promote overall well-being and potentially delay further decline of cognition and daily functioning. The goal of this mixed-methods study was to guide the development of two mind-body activity programs for CP and CD which focus on increasing walking using time goals (Active Brains) or step count reinforced by a Fitbit (Active Brains-Fitbit). RESEARCH DESIGN AND METHODS Older adults with CP and CD (N = 23) participated in a one-time focus group (four total) and completed measures of physical, emotional, and cognitive functioning. Qualitative analyses identified population-specific needs, preferences, and perceptions of proposed program skills. Quantitative analysis compared clinical characteristics to population norms and explored intercorrelations among treatment targets. RESULTS Thematic analyses revealed six main themes: (1) challenges living with CP and (2) CD, (3) current walking, (4) technology (Fitbit) to increase walking, (5) perceptions of proposed program skills (e.g., mind-body, pain, and increased walking), and (6) program barriers and facilitators. Quantitative analyses showed that (a) participants had physical function below reference values and (b) higher self-efficacy correlated with higher cognitive, emotional, and physical functioning. DISCUSSION AND IMPLICATIONS Focus group participants were enthusiastic about the proposed program skills. Current work includes open pilot testing, qualitative interviews, and a small randomized controlled trial to optimize the programs and methodology in preparation for efficacy testing against an educational control.",2021,"Quantitative analyses showed that: (1) participants had physical function below reference values, and (2) higher self-efficacy correlated with higher cognitive, emotional, and physical functioning. ","['older adults with cognitive decline', 'older adults', 'Older adults with CP and CD (N = 23']",['novel mind-body activity and pain management program'],"['challenges living with CP and (2) CD, (3) current walking, (4) technology (Fitbit) to increase walking, (5) perceptions of proposed program skills (e.g., mind-body, pain, increased walking), and (6) program barriers and facilitators', 'activity (walking', 'cognitive, emotional, and physical functioning']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",23.0,0.0267041,"Quantitative analyses showed that: (1) participants had physical function below reference values, and (2) higher self-efficacy correlated with higher cognitive, emotional, and physical functioning. ","[{'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'Mace', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Melissa V', 'Initials': 'MV', 'LastName': 'Gates', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Breanna', 'Initials': 'B', 'LastName': 'Bullard', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Ethan G', 'Initials': 'EG', 'LastName': 'Lester', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Ilyssa H', 'Initials': 'IH', 'LastName': 'Silverman', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Yakeel T', 'Initials': 'YT', 'LastName': 'Quiroz', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Vranceanu', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, Boston.'}]",The Gerontologist,['10.1093/geront/gnaa084'] 752,32613664,"Comparison of Er,Cr:YSGG laser to minimally invasive surgical technique in the treatment of intrabony defects: Six-month results of a multicenter, randomized, controlled study.","BACKGROUND The purpose of this publication is to report on the six-month clinical results and patient-reported outcomes (PROs) comparing the surgical use of the erbium, chromium-doped: yttrium, scandium, gallium, and garnet (Er,Cr:YSGG) laser (ERL) and minimally invasive surgical technique (MIST) for the treatment of intrabony defects in subjects with generalized periodontitis stage III, grade B. METHODS Fifty-three adults (29 females and 24 males; aged 19 to 73 years) with 79 intrabony defects were randomized following scaling and root planing (SRP) to receive ERL monotherapy (n = 27) or MIST (n = 26). Recession, probing depth (PD), clinical attachment level (CAL), treatment time, and PROs were assessed and compared for each treatment group. Clinical measurements were recorded at baseline, 4 to 6 weeks following SRP, and 6 months following surgical therapy. RESULTS The following primary and secondary outcome variables were non-inferior with the following margins: CAL with a non-inferiority margin of 0.6 mm (p = 0.05), PD with a non-inferiority margin of 0.5 mm (p = 0.05). Recession with a non-inferiority margin of 0.4 mm (p = 0.05). Faster procedure times were found for ERL (16.39 ± 6.21 minutes) versus MIST (20.17 ± 5.62 minutes), p = 0.0002. In the first 2 to 3 days of post-therapeutic diary outcomes, subjects reported less bruising, facial swelling, and use of ice pack for the ERL group. CONCLUSIONS This is the first multicenter, randomized, masked, and controlled study demonstrating the ERL is not inferior to MIST in terms of clinical outcomes but is superior in PROs for the surgical treatment of intrabony defects.",2021,",Cr:YSGG laser is not inferior to MIST in terms of clinical outcomes but is superior in PROs for the surgical treatment of intrabony defects.","['subjects with generalized periodontitis stage III, grade B.\nMETHODS\n\n\nFifty-three adult subjects (29 females and 24 males; 19 to 73 years) with 79 intrabony defects']","['MIST', 'scaling and root planing (SRP) to receive ERL monotherapy', 'YSGG laser to minimally invasive surgical technique', 'Er,Cr', 'Er,Cr:YSGG laser (ERL) and minimally invasive surgical technique (MIST']","['bruising, facial swelling, and use of Ice pack', 'non-inferior with the following margins', 'Recession (REC), probing depth (PD), clinical attachment level (CAL), treatment time, and PROs']","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C0879167', 'cui_str': 'Yttrium-Scandium-Gallium Garnet Lasers'}]","[{'cui': 'C0009938', 'cui_str': 'Contusion'}, {'cui': 'C0151602', 'cui_str': 'Facial swelling'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0181264', 'cui_str': 'Ice bag'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0333047', 'cui_str': 'Recession'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}]",53.0,0.0953649,",Cr:YSGG laser is not inferior to MIST in terms of clinical outcomes but is superior in PROs for the surgical treatment of intrabony defects.","[{'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Clem', 'Affiliation': 'Private practice, Fullerton, CA.'}, {'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'Heard', 'Affiliation': 'A McGuire Institute Study, Private Practice-Based Clinical Research Network, Houston, TX.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McGuire', 'Affiliation': 'A McGuire Institute Study, Private Practice-Based Clinical Research Network, Houston, TX.'}, {'ForeName': 'E Todd', 'Initials': 'ET', 'LastName': 'Scheyer', 'Affiliation': 'A McGuire Institute Study, Private Practice-Based Clinical Research Network, Houston, TX.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Richardson', 'Affiliation': 'A McGuire Institute Study, Private Practice-Based Clinical Research Network, Houston, TX.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Toback', 'Affiliation': 'A McGuire Institute Study, Private Practice-Based Clinical Research Network, Houston, TX.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Gwaltney', 'Affiliation': 'Private practice, Westerly, RI.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Gunsolley', 'Affiliation': 'Department of Periodontics, Virginia Commonwealth School of Dentistry, Richmond, VA.'}]",Journal of periodontology,['10.1002/JPER.20-0028'] 753,32616158,Association of Statin Use With Disability-Free Survival and Cardiovascular Disease Among Healthy Older Adults.,"BACKGROUND There is clinical uncertainty regarding the benefits and harms of prescribing statins in healthy subjects ≥70 years of age. OBJECTIVES The aim of this study was to examine the association among statins, dementia-free and disability-free survival, and cardiovascular disease (CVD) among healthy older adults using data from the ASPREE (Aspirin in Reducing Events in the Elderly) trial. METHODS ASPREE was a randomized trial of 19,114 community-dwelling persons in Australia and the United States ≥65 years of age and free of documented CVD, dementia, and disability. Data were collected for those ≥70 years of age, and participants who took statins at baseline were compared with those who did not using Cox proportional hazards regression with inverse probability weighting. The primary outcome, referred to as ""disability-free survival,"" was a composite of all-cause mortality, dementia, or persistent physical disability. Other outcomes included the individual components of the composite outcome, major adverse cardiovascular events, fatal CVD, myocardial infarction, and stroke. RESULTS Of the 18,096 included participants (median age 74.2 years, 56.0% women), 5,629 took statins at baseline. Over a median follow-up period of 4.7 years, baseline statin use was not associated with disability-free survival or with the risk for all-cause mortality or dementia. However, it was associated with lower risks for physical disability and all cardiovascular outcomes. CONCLUSIONS Among healthy community-dwelling adults ≥70 years of age, statin use may be beneficial for preventing physical disability and CVD but not beneficial for prolonging disability-free survival or avoiding death or dementia. Future clinical trials are needed to confirm these findings.",2020,"Over a median follow-up period of 4.7 years, baseline statin use was not associated with disability-free survival or with the risk for all-cause mortality or dementia.","['19,114 community-dwelling persons in Australia and the United States ≥65\xa0years of age and free of documented CVD, dementia, and disability', 'Of the 18,096 included participants (median age 74.2 years, 56.0% women), 5,629 took statins at baseline', 'Healthy Older Adults', 'healthy older adults', 'healthy community-dwelling adults\xa0≥70 years', 'healthy subjects\xa0≥70 years of age']",['ASPREE (Aspirin'],"['individual components of\xa0the\xa0composite outcome, major adverse cardiovascular events, fatal CVD, myocardial infarction, and stroke', 'physical disability and all cardiovascular outcomes', 'disability-free survival', 'statins, dementia-free and disability-free survival, and cardiovascular disease (CVD', 'referred to as ""disability-free survival,"" was a composite of all-cause mortality, dementia, or persistent physical disability']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}]",19114.0,0.159088,"Over a median follow-up period of 4.7 years, baseline statin use was not associated with disability-free survival or with the risk for all-cause mortality or dementia.","[{'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia. Electronic address: zhen.zhou@utas.edu.au.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Ofori-Asenso', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia; Copenhagen Centre for Regulatory Science, Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Curtis', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Breslin', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Murray', 'Affiliation': 'Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Division of Geriatrics, Department of Medicine, Hennepin HealthCare, Minneapolis, Minnesota; University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Ernst', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, University of Iowa, Iowa City, Iowa; Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia; School of Public Health, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Lockery', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Woods', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Tonkin', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.05.016'] 754,32604068,"Changes in Strength, Mobility, and Body Composition Following Self-Selected Exercise in Older Adults.","The purpose of this trial was to examine the effects of self-selected exercise intensities plus either whey protein or placebo supplementation on vital signs, body composition, bone mineral density, muscle strength, and mobility in older adults. A total of 101 participants aged 55 years and older (males [n = 34] and females [n = 67]) were evaluated before and after 12 weeks of self-selected, free-weight resistance exercise plus 30 min of self-paced walking three times per week. The participants were randomized into two groups: whey protein (n = 46) or placebo (n = 55). Three-way mixed factorial analyses of variance were used to test for mean differences for each variable. The 12 weeks of self-selected, self-paced exercise intensities improved resting heart rate, fat-free mass, percent body fat, handgrip strength, bench press strength, leg press strength, and all mobility measurements (p < .05) in males and females despite supplementation status. This suggests that additional protein in well-fed healthy older adults does not enhance the benefit of exercise.",2020,"The 12 weeks of self-selected, self-paced exercise intensities improved resting heart rate, fat-free mass, percent body fat, handgrip strength, bench press strength, leg press strength, and all mobility measurements (p < .05) in males and females despite supplementation status.","['101 participants aged 55 years and older (males [n = 34] and females [n = 67', 'Older Adults', 'older adults', 'fed healthy older adults']","['free-weight resistance exercise plus 30 min of self-paced walking three times per week', 'whey protein', 'self-selected exercise intensities plus either whey protein or placebo supplementation', 'placebo']","['vital signs, body composition, bone mineral density, muscle strength, and mobility', 'Strength, Mobility, and Body Composition', 'resting heart rate, fat-free mass, percent body fat, handgrip strength, bench press strength, leg press strength, and all mobility measurements']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",101.0,0.0477965,"The 12 weeks of self-selected, self-paced exercise intensities improved resting heart rate, fat-free mass, percent body fat, handgrip strength, bench press strength, leg press strength, and all mobility measurements (p < .05) in males and females despite supplementation status.","[{'ForeName': 'Ashley A', 'Initials': 'AA', 'LastName': 'Herda', 'Affiliation': ''}, {'ForeName': 'Brianna D', 'Initials': 'BD', 'LastName': 'McKay', 'Affiliation': ''}, {'ForeName': 'Trent J', 'Initials': 'TJ', 'LastName': 'Herda', 'Affiliation': ''}, {'ForeName': 'Pablo B', 'Initials': 'PB', 'LastName': 'Costa', 'Affiliation': ''}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Stout', 'Affiliation': ''}, {'ForeName': 'Joel T', 'Initials': 'JT', 'LastName': 'Cramer', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2019-0468'] 755,32615837,"Efficacy of a vaginal tablet as a Persian medicine product on vulvovaginal candidiasis: a double-blind, randomised, placebo-controlled trial.","Context: In Persian medicine, topical ingredients such as Rosa damascena Mill. (Rosaceae), are usually recommended for the treatment of uterine diseases. Scientific evaluation of these historical documents can be valuable for finding new potential use in conventional medicine. Objective: This clinical trial was performed to determine whether the use of the 'ward' vaginal tablet, which contains Rosa damascena, Punica granatum L. (Punicaceae), Querqus infectoria Oliv. (Fagaceae), Myrtus communis L. (Myrtaceae) and Nardostachys jatamansi (D.Don) DC. (Caprifoliaceae) could alleviate the symptoms of vulvovaginal candidiasis. Materials and methods: A parallel double-blinded placebo-controlled study was done. Eighteen to fifty-year-old women with vulvovaginal candidiasis were divided into the 'ward' and placebo groups, 46 individuals in each group. The 'ward' group received the 'ward' vaginal tablet containing 200 mg of dried extract. Placebo group received a placebo (composed of corn starch and lactose). One tablet was applied through the vagina for 7 consecutive nights. Results: Two weeks after medication administration, the vaginal discharge sample of patients was re-cultured; 29 patients (63.045%) in the 'ward' group and 6 (13.04%) patients in the placebo group had negative culture ( p  < 0.001). All clinical symptoms including itching, irritation, and vaginal discharge were significantly reduced in the 'ward' group compared with the placebo group following the intervention and the follow up ( p  < 0.05). Discussion and conclusions: The findings suggest the 'ward' vaginal tablet could ameliorate vulvovaginal candidiasis. Future larger studies are recommended due to compare the therapeutic effect of the 'ward' vaginal tablet with common treatments.",2020,"All clinical symptoms including itching, irritation, and vaginal discharge were significantly reduced in the 'ward' group compared with the placebo group following the intervention and the follow up ( p  < 0.05).","['Eighteen to fifty-year-old women with vulvovaginal candidiasis', 'groups, 46 individuals in each group']","['Placebo', 'vaginal tablet', 'placebo (composed of corn starch and lactose', ""ward' vaginal tablet containing 200\u2009mg of dried extract"", 'placebo']","['Fagaceae), Myrtus communis L. (Myrtaceae) and Nardostachys jatamansi (D.Don) DC', 'vaginal discharge sample', 'vulvovaginal candidiasis', 'symptoms of vulvovaginal candidiasis', 'itching, irritation, and vaginal discharge', 'negative culture']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0700345', 'cui_str': 'Candidal vulvovaginitis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042264', 'cui_str': 'Vaginal tablet'}, {'cui': 'C1384515', 'cui_str': 'corn starch'}, {'cui': 'C0022949', 'cui_str': 'Lactose'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1720167', 'cui_str': 'Dry extract'}]","[{'cui': 'C0950075', 'cui_str': 'Family Fagaceae'}, {'cui': 'C3853725', 'cui_str': 'Myrtus communis whole extract'}, {'cui': 'C1021351', 'cui_str': 'Nardostachys'}, {'cui': 'C0227791', 'cui_str': 'Vaginal discharge'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0700345', 'cui_str': 'Candidal vulvovaginitis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0010453', 'cui_str': 'Culture'}]",,0.311822,"All clinical symptoms including itching, irritation, and vaginal discharge were significantly reduced in the 'ward' group compared with the placebo group following the intervention and the follow up ( p  < 0.05).","[{'ForeName': 'Somayyeh', 'Initials': 'S', 'LastName': 'Khalilzadeh', 'Affiliation': 'Department of Persian Medicine, School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Eftkhar', 'Affiliation': 'Department of Obstetrics and Gynecology, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'Shirbeigi', 'Affiliation': 'Department of Persian Medicine, School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Tabarrai', 'Affiliation': 'Department of Persian Medicine, School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Tayebeh', 'Initials': 'T', 'LastName': 'Toliyat', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shamim', 'Initials': 'S', 'LastName': 'Fayazmanesh', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Ghasemi', 'Affiliation': 'Medical Mycology of Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Safar', 'Initials': 'S', 'LastName': 'Shamohammadi', 'Affiliation': 'Razi Hospital Laboratory, Faculty member in medicine, Tehran University of Medical Sciences, Tehran, Iran.'}]",Pharmaceutical biology,['10.1080/13880209.2020.1784236'] 756,32602148,Antacid Monotherapy Is More Effective in Relieving Epigastric Pain Than in Combination With Lidocaine: A Randomized Double-blind Clinical Trial.,,2020,"This was a double-blind, randomized clinical trial comparing three different solutions for the treatment of adults with epigastric pain or dyspepsia presenting to the emergency department (ED).","['Royal Melbourne Hospital, a tertiary, adult-only, inner-city center in Melbourne with 75,000 annual ED visits', 'adults with epigastric pain or dyspepsia presenting to the emergency department (ED']","['Antacid monotherapy', 'lidocaine']",['epigastric pain'],"[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0557849', 'cui_str': 'Inner city'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0232493', 'cui_str': 'Epigastric pain'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]","[{'cui': 'C0003138', 'cui_str': 'Antacid'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0232493', 'cui_str': 'Epigastric pain'}]",,0.679809,"This was a double-blind, randomized clinical trial comparing three different solutions for the treatment of adults with epigastric pain or dyspepsia presenting to the emergency department (ED).","[{'ForeName': 'Jaimee', 'Initials': 'J', 'LastName': 'Warren', 'Affiliation': 'From the, Emergency Department, Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Blake', 'Initials': 'B', 'LastName': 'Cooper', 'Affiliation': 'From the, Emergency Department, Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Jermakoff', 'Affiliation': 'From the, Emergency Department, Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Knott', 'Affiliation': 'From the, Emergency Department, Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14069'] 757,32602162,Convergent cross-sectional and longitudinal evidence for gaming-cue specific posterior parietal dysregulations in early stages of internet gaming disorder.,"Exaggerated reactivity to drug-cues and emotional dysregulations represent key symptoms of early stages of substance use disorders. The diagnostic criteria for (Internet) gaming disorder strongly resemble symptoms for substance-related addictions. However, previous cross-sections studies revealed inconsistent results with respect to neural cue reactivity and emotional dysregulations in these populations. To this end, the present fMRI study applied a combined cross-sectional and longitudinal design in regular online gamers (n = 37) and gaming-naïve controls (n = 67). To separate gaming-associated changes from predisposing factors, gaming-naive subjects were randomly assigned to 6 weeks of daily Internet gaming or a non-gaming condition. At baseline and after the training, subjects underwent an fMRI paradigm presenting gaming-related cues and non-gaming-related emotional stimuli. Cross-sectional comparisons revealed gaming-cue specific enhanced valence attribution and neural reactivity in a parietal network, including the posterior cingulate in regular gamers as compared to gaming naïve-controls. Longitudinal analysis revealed that 6 weeks of gaming elevated valence ratings as well as neural cue-reactivity in a similar parietal network, specifically the posterior cingulate in previously gaming-naïve controls. Together, the longitudinal design did not reveal supporting evidence for altered emotional processing of non-gaming associated stimuli in regular gamers whereas convergent evidence for increased emotional and neural reactivity to gaming-associated stimuli was observed. Findings suggest that exaggerated neural reactivity in posterior parietal regions engaged in default mode and automated information processing already occur during early stages of regular gaming and probably promote continued engagement in gaming behavior.",2021,"Longitudinal analysis revealed that 6 weeks of gaming elevated valence ratings as well as neural cue-reactivity in a similar parietal network, specifically the posterior cingulate in previously gaming-naïve controls.",['regular online gamers (n = 37) and gaming-naïve controls (n = 67'],"['daily Internet gaming or a non-gaming condition', 'fMRI paradigm presenting gaming-related cues and non-gaming-related emotional stimuli']",[],"[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]",[],67.0,0.0398672,"Longitudinal analysis revealed that 6 weeks of gaming elevated valence ratings as well as neural cue-reactivity in a similar parietal network, specifically the posterior cingulate in previously gaming-naïve controls.","[{'ForeName': 'Fangwen', 'Initials': 'F', 'LastName': 'Yu', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, Key Laboratory for NeuroInformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Rayna', 'Initials': 'R', 'LastName': 'Sariyska', 'Affiliation': 'Institute of Psychology and Education, Ulm University, Ulm, Baden-Württemberg, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Lachmann', 'Affiliation': 'Institute of Psychology and Education, Ulm University, Ulm, Baden-Württemberg, Germany.'}, {'ForeName': 'Qianqian', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, Key Laboratory for NeuroInformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reuter', 'Affiliation': 'Department of Psychology, University of Bonn, Bonn, North Rhine-Westphalia, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Weber', 'Affiliation': 'Center for Economics and Neuroscience, University of Bonn, Bonn, North Rhine-Westphalia, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Trautner', 'Affiliation': 'Center for Economics and Neuroscience, University of Bonn, Bonn, North Rhine-Westphalia, Germany.'}, {'ForeName': 'Shuxia', 'Initials': 'S', 'LastName': 'Yao', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, Key Laboratory for NeuroInformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Montag', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, Key Laboratory for NeuroInformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Becker', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, Key Laboratory for NeuroInformation, University of Electronic Science and Technology of China, Chengdu, China.'}]",Addiction biology,['10.1111/adb.12933'] 758,32604436,The Effectiveness of Psycho-Educational and Cognitive-Behavioral Counseling on Female Sexual Dysfunction.,"INTRODUCTION Sexual function is a multidimensional phenomenon that is affected by many biological and psychological factors. Cognitive-behavioral sex therapies are among the most common nonpharmacological approaches to psychosexual problems. The purpose of the present study was to investigate the effectiveness of psychoeducational and cognitive-behavioral counseling on female sexual dysfunction. METHODS The present study was a clinical trial with intervention and control groups. The study population consisted of women referring to the general clinic of a governmental hospital in Iran. After completing the demographic questionnaire and Female Sexual Function Index (FSFI), those who obtained the cutoff score ≤ 28 were contacted and invited to participate in the study. Convenience sampling method was used and 35 subjects were randomly allocated for each group. Eight counseling sessions were held for the intervention group (two/week/1.5 hour). Post-test was taken from both groups after 1 month, and the results were statistically analyzed by PASW Statistics for Windows, Version 18 (SPSS Inc., Chicago, IL, USA). RESULTS The total mean scores of FSFI and the subscales of sexual desire, arousal, orgasm, and satisfaction were significantly higher in the intervention group than in the control group after the intervention. In addition, postintervention pain mean scores in the intervention group were significantly lower than in the control group ( p  < 0.05). CONCLUSION The results of the present study indicate that psychoeducational cognitive-behavioral counseling is effective in improving female sexual function. It is recommended to compare the effects of psychoeducational cognitive-behavioral counseling on sexual dysfunctions of couples and with a larger sample size in future research.",2020,"The total mean scores of FSFI and the subscales of sexual desire, arousal, orgasm, and satisfaction were significantly higher in the intervention group than in the control group after the intervention.","['35 subjects', 'Female Sexual Dysfunction', 'women referring to the general clinic of a governmental hospital in Iran', 'female sexual dysfunction']","['Psycho-Educational and Cognitive-Behavioral Counseling', 'psychoeducational and cognitive-behavioral counseling', 'psychoeducational cognitive-behavioral counseling']","['total mean scores of FSFI and the subscales of sexual desire, arousal, orgasm, and satisfaction', 'demographic questionnaire and Female Sexual Function Index (FSFI', 'PASW Statistics for Windows, Version 18 (SPSS Inc., Chicago, IL, USA', 'postintervention pain mean scores']","[{'cui': 'C1112442', 'cui_str': 'Female sexual dysfunction'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C4546207', 'cui_str': 'Behavioral counseling'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023618', 'cui_str': 'Libido'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0029260', 'cui_str': 'Sexual orgasm'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",35.0,0.0133763,"The total mean scores of FSFI and the subscales of sexual desire, arousal, orgasm, and satisfaction were significantly higher in the intervention group than in the control group after the intervention.","[{'ForeName': 'Firoozeh', 'Initials': 'F', 'LastName': 'Mirzaee', 'Affiliation': 'Razi Nursing and Midwifery Faculty, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Ahmadi', 'Affiliation': 'Razi Nursing and Midwifery Faculty, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Zangiabadi', 'Affiliation': 'Razi Nursing and Midwifery Faculty, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Moghaddameh', 'Initials': 'M', 'LastName': 'Mirzaee', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Kerman University of Medical Sciences, Kerman, Iran.'}]",Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia,['10.1055/s-0040-1712483'] 759,32619240,Cognitive effects of split and continuous sleep schedules in adolescents differ according to total sleep opportunity.,"STUDY OBJECTIVES We compared the basic cognitive functions of adolescents undergoing split (nocturnal sleep + daytime nap) and continuous nocturnal sleep schedules when total sleep opportunity was either below or within the recommended range (i.e. 6.5 or 8 h). METHODS Adolescent participants (age: 15-19 year) in the 8-h split (n = 24) and continuous (n = 29) sleep groups were compared with 6.5-h split and continuous sleep groups from a previous study (n = 58). These protocols involved two baseline nights (9-h time-in-bed [TIB]), 5 nights of sleep manipulation, 2 recovery nights (9-h TIB), followed by a second cycle of sleep manipulation (3 nights) and recovery (2 nights). Cognitive performance, subjective sleepiness, and mood were evaluated daily; sleep was assessed using polysomnography. RESULTS Splitting 6.5 h of sleep with a mid-afternoon nap offered a boost to cognitive function compared to continuous nocturnal sleep. However, when total TIB across 24 h increased to 8 h, the split and continuous sleep groups performed comparably in tests evaluating vigilance, working memory, executive function, processing speed, subjective sleepiness, and mood. CONCLUSIONS In adolescents, the effects of split sleep on basic cognitive functions vary by the amount of total sleep obtained. As long as the total sleep opportunity across 24 h is within the recommended range, students may fulfill sleep requirements by adopting a split sleep schedule consisting of a shorter period of nocturnal sleep combined with a mid-afternoon nap, without significant impact on basic cognitive functions. CLINICAL TRIAL REGISTRATION NCT04044885.",2020,"However, when total TIB across 24 h increased to 8 h, the split and continuous sleep groups performed comparably in tests evaluating vigilance, working memory, executive function, processing speed, subjective sleepiness and mood. ","['Adolescents Differ', 'adolescents undergoing', 'Adolescent participants (age: 15-19 y) in the 8-h split (n = 24) and continuous (n = 29) sleep groups']","['Split and Continuous Sleep Schedules', 'split (nocturnal sleep + daytime nap) and continuous nocturnal sleep schedules', 'split sleep']","['tests evaluating vigilance, working memory, executive function, processing speed, subjective sleepiness and mood', 'Cognitive performance, subjective sleepiness, and mood were evaluated daily; sleep', 'total TIB']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0067518', 'cui_str': 'N-(4-aminophenethyl)spiroperidol'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.0146999,"However, when total TIB across 24 h increased to 8 h, the split and continuous sleep groups performed comparably in tests evaluating vigilance, working memory, executive function, processing speed, subjective sleepiness and mood. ","[{'ForeName': 'June C', 'Initials': 'JC', 'LastName': 'Lo', 'Affiliation': 'Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Ruth L F', 'Initials': 'RLF', 'LastName': 'Leong', 'Affiliation': 'Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Alyssa S C', 'Initials': 'ASC', 'LastName': 'Ng', 'Affiliation': 'Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'S Azrin', 'Initials': 'SA', 'LastName': 'Jamaluddin', 'Affiliation': 'Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Ju Lynn', 'Initials': 'JL', 'LastName': 'Ong', 'Affiliation': 'Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Shohreh', 'Initials': 'S', 'LastName': 'Ghorbani', 'Affiliation': 'Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'TeYang', 'Initials': 'T', 'LastName': 'Lau', 'Affiliation': 'Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Nicholas I Y N', 'Initials': 'NIYN', 'LastName': 'Chee', 'Affiliation': 'Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Joshua J', 'Initials': 'JJ', 'LastName': 'Gooley', 'Affiliation': 'Neuroscience and Behavioral Disorders Program, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Michael W L', 'Initials': 'MWL', 'LastName': 'Chee', 'Affiliation': 'Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}]",Sleep,['10.1093/sleep/zsaa129'] 760,32609756,Participation in adherence clubs and on-time drug pickup among HIV-infected adults in Zambia: A matched-pair cluster randomized trial.,"BACKGROUND Current models of HIV service delivery, with frequent facility visits, have led to facility congestion, patient and healthcare provider dissatisfaction, and suboptimal quality of services and retention in care. The Zambian urban adherence club (AC) is a health service innovation designed to improve on-time drug pickup and retention in HIV care through off-hours facility access and pharmacist-led group drug distribution. Similar models of differentiated service delivery (DSD) have shown promise in South Africa, but observational analyses of these models are prone to bias and confounding. We sought to evaluate the effectiveness and implementation of ACs in Zambia using a more rigorous study design. METHODS AND FINDINGS Using a matched-pair cluster randomized study design (ClinicalTrials.gov: NCT02776254), 10 clinics were randomized to intervention (5 clinics) or control (5 clinics). At each clinic, between May 19 and October 27, 2016, a systematic random sample was assessed for eligibility (HIV+, age ≥ 14 years, on ART >6 months, not acutely ill, CD4 count not <200 cells/mm3) and willingness to participate in an AC. Clinical and antiretroviral drug pickup data were obtained through the existing electronic medical record. AC meeting attendance data were collected at intervention facilities prospectively through October 28, 2017. The primary outcome was time to first late drug pickup (>7 days late). Intervention effect was estimated using unadjusted Kaplan-Meier survival curves and a Cox proportional hazards model to derive an adjusted hazard ratio (aHR). Medication possession ratio (MPR) and implementation outcomes (adoption, acceptability, appropriateness, feasibility, and fidelity) were additionally evaluated as secondary outcomes. Baseline characteristics were similar between 571 intervention and 489 control participants with respect to median age (42 versus 41 years), sex (62% versus 66% female), median time since ART initiation (4.8 versus 5.0 years), median CD4 count at study enrollment (506 versus 533 cells/mm3), and baseline retention (53% versus 55% with at least 1 late drug pickup in previous 12 months). The rate of late drug pickup was lower in intervention participants compared to control participants (aHR 0.26, 95% CI 0.15-0.45, p < 0.001). Median MPR was 100% in intervention participants compared to 96% in control participants (p < 0.001). Although 18% (683/3,734) of AC group meeting visits were missed, on-time drug pickup (within 7 days) still occurred in 51% (350/683) of these missed visits through alternate means (use of buddy pickup or early return to the facility). Qualitative evaluation suggests that the intervention was acceptable to both patients and providers. While patients embraced the convenience and patient-centeredness of the model, preference for traditional adherence counseling and need for greater human resources influenced intervention appropriateness and feasibility from the provider perspective. The main limitations of this study were the small number of clusters, lack of viral load data, and relatively short follow-up period. CONCLUSIONS ACs were found to be an effective model of service delivery for reducing late ART drug pickup among HIV-infected adults in Zambia. Drug pickup outside of group meetings was relatively common and underscores the need for DSD models to be flexible and patient-centered if they are to be effective. TRIAL REGISTRATION ClinicalTrials.gov NCT02776254.",2020,Median MPR was 100% in intervention participants compared to 96% in control participants (p < 0.001).,"['At each clinic, between May 19 and October 27, 2016, a systematic random sample was assessed for eligibility (HIV+, age ≥ 14 years, on ART >6 months, not acutely ill, CD4 count not <200 cells/mm3) and willingness to participate in an AC', 'Zambian urban adherence club (AC', '489 control participants with respect to median age (42 versus 41 years), sex (62% versus 66% female', 'HIV-infected adults in Zambia', '10 clinics were randomized to intervention (5 clinics) or control (5 clinics']",['differentiated service delivery (DSD'],"['rate of late drug pickup', 'median time since ART initiation', 'Median MPR', 'unadjusted Kaplan-Meier survival curves', 'time to first late drug pickup', 'median CD4 count', 'Medication possession ratio (MPR) and implementation outcomes (adoption, acceptability, appropriateness, feasibility, and fidelity']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0439243', 'cui_str': 'uL'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",10.0,0.184599,Median MPR was 100% in intervention participants compared to 96% in control participants (p < 0.001).,"[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Roy', 'Affiliation': 'University of California, San Francisco, San Fancisco, California, United States of America.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Bolton-Moore', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Izukanji', 'Initials': 'I', 'LastName': 'Sikazwe', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Mpande', 'Initials': 'M', 'LastName': 'Mukumbwa-Mwenechanya', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Efronson', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Chanda', 'Initials': 'C', 'LastName': 'Mwamba', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Somwe', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Estella', 'Initials': 'E', 'LastName': 'Kalunkumya', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Mwansa', 'Initials': 'M', 'LastName': 'Lumpa', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Jake', 'Initials': 'J', 'LastName': 'Pry', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Wilbroad', 'Initials': 'W', 'LastName': 'Mutale', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ehrenkranz', 'Affiliation': 'Bill and Melinda Gates Foundation, Seattle, Washington, United States of America.'}, {'ForeName': 'David V', 'Initials': 'DV', 'LastName': 'Glidden', 'Affiliation': 'University of California, San Francisco, San Fancisco, California, United States of America.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Padian', 'Affiliation': 'University of California, Berkeley, Berkeley, California, United States of America.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Topp', 'Affiliation': 'James Cook University, Townsville, Queensland, Australia.'}, {'ForeName': 'Elvin', 'Initials': 'E', 'LastName': 'Geng', 'Affiliation': 'University of California, San Francisco, San Fancisco, California, United States of America.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Holmes', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland, United States of America.'}]",PLoS medicine,['10.1371/journal.pmed.1003116'] 761,32616589,Vitamin C to Pregnant Smokers Persistently Improves Infant Airway Function to 12 Months of Age: A Randomised Trial.,"BACKGROUND Vitamin C (500 mg·day -1 ) supplementation for pregnant smokers has been reported to increase newborn pulmonary function and infant forced expiratory flows (FEFs) at 3 months of age. Its effect on airway function through 12 months of age has not been reported. OBJECTIVE To assess whether vitamin C supplementation to pregnant smokers is associated with a sustained increased airway function in their infants through 12 months of age. METHODS This is a prespecified secondary outcome of a randomised, double-blind, placebo-controlled trial that randomised 251 pregnant smokers between 13 and 23 weeks of gestation: 125 to 500 mg·day -1 vitamin C and 126 to placebo. Smoking cessation counselling was provided. FEFs performed at 3 and 12 months of age were analysed by repeated measures analysis of covariance. RESULTS FEFs were performed in 222 infants at 3 months and 202 infants at 12 months of age. The infants allocated to vitamin C had significantly increased FEFs over the first year of life compared to those allocated to placebo. The overall increased flows were: 40.2 mL·sec -1 for FEF 75 (adjusted 95% CI for difference 6.6 to 73.8; p=0.025); 58.3 mL·sec -1 for FEF 50 (95% CI 10.9 to 105.8; p=0.0081); and 55.1 mL·sec -1 for FEF 25-75 (95% CI, 9.7 to 100.5; p=0.013). CONCLUSIONS In offspring of pregnant smokers randomised to vitamin C versus placebo, vitamin C during pregnancy was associated with a small but significantly increased airway function at 3 and 12 months of age, suggesting a potential shift to a higher airway function trajectory curve. Continued follow-up is underway.",2020,The infants allocated to vitamin C had significantly increased FEFs over the first year of life compared to those allocated to placebo.,"['Pregnant Smokers', 'pregnant smokers', '222 infants at 3\u2005months and 202 infants at 12\u2005months of age', '251 pregnant smokers between 13 and 23\u2005weeks of gestation: 125 to 500\u2005mg·day -1 vitamin C and 126 to']","['Vitamin C (500\u2005mg·day -1 ) supplementation', 'Vitamin C', 'vitamin C versus placebo, vitamin C', 'vitamin C', 'vitamin C supplementation', 'placebo']","['newborn pulmonary function and infant forced expiratory flows (FEFs', 'FEFs', 'airway function']","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0470256', 'cui_str': '126'}]","[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4524018', 'cui_str': 'Vitamin C supplementation'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C3804964', 'cui_str': 'Forced expiratory flow'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",251.0,0.569629,The infants allocated to vitamin C had significantly increased FEFs over the first year of life compared to those allocated to placebo.,"[{'ForeName': 'Cindy T', 'Initials': 'CT', 'LastName': 'McEvoy', 'Affiliation': 'Department of Pediatrics, Oregon Health & Science University, Portland, OR, USA mcevoyc@ohsu.edu.'}, {'ForeName': 'Lyndsey E', 'Initials': 'LE', 'LastName': 'Shorey-Kendrick', 'Affiliation': 'Division of Neuroscience, Oregon National Primate Research Center, Beaverton, OR, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Milner', 'Affiliation': 'Department of Pediatrics, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Schilling', 'Affiliation': 'Department of Pediatrics, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Tiller', 'Affiliation': 'Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Vuylsteke', 'Affiliation': 'Department of Pediatrics, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Scherman', 'Affiliation': 'Department of Pediatrics, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Jackson', 'Affiliation': 'PeaceHealth Southwest Medical Center, Vancouver, WA, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Haas', 'Affiliation': 'Department of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Harris', 'Affiliation': 'Department of Pediatrics, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Byung S', 'Initials': 'BS', 'LastName': 'Park', 'Affiliation': 'Oregon Health & Science University-Portland State University, School of Public Health and Knight Cancer Institute, Portland, OR, USA.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Vu', 'Affiliation': 'Department of Medical Informatics and Clinical Epidemiology, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Dale F', 'Initials': 'DF', 'LastName': 'Kraemer', 'Affiliation': 'Department of Medical Informatics and Clinical Epidemiology, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gonzales', 'Affiliation': 'Division of Pulmonary & Critical Care Medicine, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Bunten', 'Affiliation': 'Vancouver Clinic, Vancouver, WA, USA.'}, {'ForeName': 'Eliot R', 'Initials': 'ER', 'LastName': 'Spindel', 'Affiliation': 'Division of Neuroscience, Oregon National Primate Research Center, Beaverton, OR, USA.'}, {'ForeName': 'Cynthia D', 'Initials': 'CD', 'LastName': 'Morris', 'Affiliation': 'Department of Medical Informatics and Clinical Epidemiology, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Tepper', 'Affiliation': 'Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, USA.'}]",The European respiratory journal,['10.1183/13993003.02208-2019'] 762,32619561,"ERGO2: A Prospective, Randomized Trial of Calorie-Restricted Ketogenic Diet and Fasting in Addition to Reirradiation for Malignant Glioma.","PURPOSE ERGO2 is the first randomized clinical trial on a calorically restricted ketogenic diet (KD) and intermittent fasting (KD-IF) in addition to reirradiation for recurrent malignant gliomas. METHODS AND MATERIALS Fifty patients were randomized 1:1 to reirradiation combined with either a calorically unrestricted diet or KD-IF. The KD-IF schedule included 3 days of KD (21-23 kcal/kg/d), followed by 3 days of fasting and again 3 days of KD. Primary endpoint was progression-free survival (PFS) at 6 months (PFS6). Secondary endpoints were PFS, local PFS, overall survival (OS), frequency of epileptic seizures, rate of ketosis and quality of life. RESULTS Four patients quit the trial before treatment and 3 patients stopped KD-IF prematurely. Of the 20 patients who completed KD-IF, 17 patients developed ketosis at day 6 and glucose levels declined significantly. KD-IF was well-tolerated with a modest weight loss of -2.1 ± 1.8 kg. No severe adverse events attributable to the diet occurred. PFS6 was not significantly different between the 2 groups (KD-IF: 20%; calorically unrestricted diet: 16%). Similarly, no difference in PFS, local PFS6, or OS was observable. Explorative analysis revealed that patients in the KD-IF group who had a glucose level of less than the median (83.5 mg/dL) on day 6 had significantly longer PFS and OS compared with those above the median (P < .05). CONCLUSIONS KD-IF is feasible and effective in inducing ketosis in heavily pretreated patients with recurrent glioma. However, the short schedule reported here failed to increase the efficacy of reirradiation. CLINICALTRIALS. GOV NUMBER NCT01754350.",2020,"PFS6 was not significantly different between the two groups (KD-IF: 20%, SD: 16%).","['50 Patients', 'heavily pretreated patients with recurrent glioma', 'malignant glioma']","['calorie restricted ketogenic diet and fasting in addition to re-irradiation', 're-irradiation combined with either calorically unrestricted diet (SD) or KD-IF', 'ERGO2', 'calorically restricted ketogenic diet (KD) and intermittent fasting (KD-IF']","['ketosis at day 6 and glucose levels', 'progression-free survival (PFS) rate at 6 months (PFS6', 'severe adverse events', 'PFS, local PFS, overall survival (OS), frequency of epileptic seizures, rate of ketosis and quality of life', 'PFS6', 'PFS, local PFS6 and OS', 'PFS and OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C0555198', 'cui_str': 'Glioma, malignant, no ICD-O subtype'}]","[{'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4042794', 'cui_str': 'Re Irradiation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C4704881', 'cui_str': 'Intermittent Fasting'}]","[{'cui': 'C0022638', 'cui_str': 'Ketosis'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",50.0,0.0608039,"PFS6 was not significantly different between the two groups (KD-IF: 20%, SD: 16%).","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Voss', 'Affiliation': 'Dr Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; University Cancer Center Frankfurt, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; German Cancer Consortium, Partner Site Frankfurt, and German Cancer Research Center, Heidelberg, Germany; Frankfurt Cancer Institute, Frankfurt, Germany. Electronic address: martin.voss@kgu.de.'}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'Wagner', 'Affiliation': 'University Cancer Center Frankfurt, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; German Cancer Consortium, Partner Site Frankfurt, and German Cancer Research Center, Heidelberg, Germany; Frankfurt Cancer Institute, Frankfurt, Germany; Institute of Neuroradiology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'von Mettenheim', 'Affiliation': 'Dr Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; University Cancer Center Frankfurt, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; German Cancer Consortium, Partner Site Frankfurt, and German Cancer Research Center, Heidelberg, Germany; Frankfurt Cancer Institute, Frankfurt, Germany.'}, {'ForeName': 'Patrick N', 'Initials': 'PN', 'LastName': 'Harter', 'Affiliation': 'University Cancer Center Frankfurt, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; German Cancer Consortium, Partner Site Frankfurt, and German Cancer Research Center, Heidelberg, Germany; Frankfurt Cancer Institute, Frankfurt, Germany; Institute of Neurology (Edinger-Institute), University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Katharina J', 'Initials': 'KJ', 'LastName': 'Wenger', 'Affiliation': 'University Cancer Center Frankfurt, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; German Cancer Consortium, Partner Site Frankfurt, and German Cancer Research Center, Heidelberg, Germany; Frankfurt Cancer Institute, Frankfurt, Germany; Institute of Neuroradiology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Kea', 'Initials': 'K', 'LastName': 'Franz', 'Affiliation': 'University Cancer Center Frankfurt, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; German Cancer Consortium, Partner Site Frankfurt, and German Cancer Research Center, Heidelberg, Germany; Frankfurt Cancer Institute, Frankfurt, Germany; Department of Neurosurgery, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Bojunga', 'Affiliation': 'Department of Medicine 1, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Vetter', 'Affiliation': 'Dr Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; University Cancer Center Frankfurt, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; German Cancer Consortium, Partner Site Frankfurt, and German Cancer Research Center, Heidelberg, Germany; Frankfurt Cancer Institute, Frankfurt, Germany.'}, {'ForeName': 'Ruediger', 'Initials': 'R', 'LastName': 'Gerlach', 'Affiliation': 'Department of Neurosurgery, HELIOS Hospital Erfurt, Erfurt, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Glatzel', 'Affiliation': 'Department of Radiation Oncology, HELIOS Hospital Erfurt, Erfurt, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Paulsen', 'Affiliation': 'Department of Radiation Oncology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Hattingen', 'Affiliation': 'University Cancer Center Frankfurt, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; German Cancer Consortium, Partner Site Frankfurt, and German Cancer Research Center, Heidelberg, Germany; Frankfurt Cancer Institute, Frankfurt, Germany; Institute of Neuroradiology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Baehr', 'Affiliation': 'Dr Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; University Cancer Center Frankfurt, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; German Cancer Consortium, Partner Site Frankfurt, and German Cancer Research Center, Heidelberg, Germany; Frankfurt Cancer Institute, Frankfurt, Germany.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Ronellenfitsch', 'Affiliation': 'Dr Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; University Cancer Center Frankfurt, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; German Cancer Consortium, Partner Site Frankfurt, and German Cancer Research Center, Heidelberg, Germany; Frankfurt Cancer Institute, Frankfurt, Germany.'}, {'ForeName': 'Emmanouil', 'Initials': 'E', 'LastName': 'Fokas', 'Affiliation': 'University Cancer Center Frankfurt, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; German Cancer Consortium, Partner Site Frankfurt, and German Cancer Research Center, Heidelberg, Germany; Frankfurt Cancer Institute, Frankfurt, Germany; Department of Radiotherapy and Oncology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Detlef', 'Initials': 'D', 'LastName': 'Imhoff', 'Affiliation': 'University Cancer Center Frankfurt, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; German Cancer Consortium, Partner Site Frankfurt, and German Cancer Research Center, Heidelberg, Germany; Frankfurt Cancer Institute, Frankfurt, Germany; Department of Radiotherapy and Oncology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Joachim P', 'Initials': 'JP', 'LastName': 'Steinbach', 'Affiliation': 'Dr Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; University Cancer Center Frankfurt, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; German Cancer Consortium, Partner Site Frankfurt, and German Cancer Research Center, Heidelberg, Germany; Frankfurt Cancer Institute, Frankfurt, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Rödel', 'Affiliation': 'University Cancer Center Frankfurt, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; German Cancer Consortium, Partner Site Frankfurt, and German Cancer Research Center, Heidelberg, Germany; Frankfurt Cancer Institute, Frankfurt, Germany; Department of Radiotherapy and Oncology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Rieger', 'Affiliation': 'Dr Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; Interdisciplinary Division of Neuro-Oncology, University Hospital Tübingen, Tübingen, Germany.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.06.021'] 763,32627589,"Effectiveness of social media (Facebook), targeted mailing, and in-person solicitation for the recruitment of young adult in a diabetes self-management clinical trial.","BACKGROUND/AIMS Research is needed to identify promising recruitment strategies to reach and engage diverse young adults in diabetes clinical research. The aim of this study was to examine the relative strengths and weaknesses of three recruitment strategies used in a diabetes self-management clinical trial: social media advertising (Facebook), targeted mailing, and in-person solicitation of clinic patients. METHODS Strategies were compared in terms of (1) cost-effectiveness (i.e. cost of recruitment/number of enrolled participants), (2) ability to yield participants who would not otherwise be reached by alternative strategies, and (3) likelihood of participants recruited through each strategy to adhere to study procedures. We further explored the appeal (overall and among age and gender subgroups) of social media advertisement features. RESULTS In-person recruitment of clinic patients was overall the most cost-effective strategy. However, differences in demographic, clinical, and psychosocial characteristics of participants recruited via different strategies suggest that the combination of these approaches yielded a more diverse sample than would any one strategy alone. Once successfully enrolled, there was no difference in study completion and intervention adherence between individuals recruited by the three recruitment strategies. CONCLUSIONS Ultimately, the utility of a recruitment strategy is defined by its ability to effectively attract people representative of the target population who are willing to enroll in and complete the study. Leveraging a variety of recruitment strategies appears to produce a more representative sample of young adults, including those who are less engaged in diabetes care.",2020,"Once successfully enrolled, there was no difference in study completion and intervention adherence between individuals recruited by the three recruitment strategies. ","['to yield participants who would not otherwise be reached by alternative strategies, and (3) likelihood of participants recruited through each strategy to adhere to study procedures']","['social media (Facebook), targeted mailing, and in-person solicitation']","['cost-effectiveness (i.e. cost of recruitment/number of enrolled participants), (2) ability']","[{'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",3.0,0.147519,"Once successfully enrolled, there was no difference in study completion and intervention adherence between individuals recruited by the three recruitment strategies. ","[{'ForeName': 'Sarah-Jeanne', 'Initials': 'SJ', 'LastName': 'Salvy', 'Affiliation': 'Research Center for Health Equity, Cedars-Sinai Medical Center, West Hollywood, CA, USA.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Carandang', 'Affiliation': 'University of California at San Diego, San Diego, CA, USA.'}, {'ForeName': 'Cheryl Lp', 'Initials': 'CL', 'LastName': 'Vigen', 'Affiliation': 'Chan Division of Occupational Science and Occupational Therapy, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Concha-Chavez', 'Affiliation': 'Northern Arizona University, Phoenix, AZ, USA.'}, {'ForeName': 'Paola A', 'Initials': 'PA', 'LastName': 'Sequeira', 'Affiliation': 'Los Angeles Department of Health Services, Los Angeles, CA, USA.'}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'Blanchard', 'Affiliation': 'Chan Division of Occupational Science and Occupational Therapy, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Diaz', 'Affiliation': 'Chan Division of Occupational Science and Occupational Therapy, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Raymond', 'Affiliation': ""Children's Hospital Los Angeles, Los Angeles, CA, USA.""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Pyatak', 'Affiliation': 'Chan Division of Occupational Science and Occupational Therapy, University of Southern California, Los Angeles, CA, USA.'}]","Clinical trials (London, England)",['10.1177/1740774520933362'] 764,32628146,The ISCHEMIA trial: Implications for non-invasive imaging.,"Coronary artery disease (CAD) is highly prevalent and constitutes the single most common cause of death worldwide. However, the diagnosis of CAD remains challenging. There are two ways to approach the diagnosis of CAD, namely (1) by a functional non-invasive stress test to detect ischemia (stress echocardiography, stress cardiovascular magnetic resonance, single-photon emission computed tomography, positron emission tomography) or (2) by imaging for stenosis visualization (coronary computed tomography angiography or invasive coronary angiography). There are also two approaches for treatment: medical treatment and revascularization. The International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial investigated the outcome differences of patients who had moderate to severe ischemia on stress testing and who, after CT angiography, had ruled out left main stenosis and demonstrated at least 1 coronary artery stenosis exceeding 50%. The patients were randomized to an initially conservative treatment versus immediate revascularization. No difference in hard outcomes was found, but angina relief was more effective in the revascularization group. In this article, we explore the implications of the ISCHEMIA trial for non-invasive testing in suspected CAD.",2020,"No difference in hard outcomes was found, but angina relief was more effective in the revascularization group.","['patients who had moderate to severe ischemia on stress testing and who, after CT angiography, had ruled out left main stenosis and demonstrated at least 1 coronary artery stenosis exceeding 50']","['Medical and Invasive Approaches (ISCHEMIA', 'imaging for stenosis visualization (coronary computed tomography angiography or invasive coronary angiography', 'initially conservative treatment versus immediate revascularization']",['angina relief'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0242231', 'cui_str': 'Coronary artery stenosis'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]","[{'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}]",,0.049503,"No difference in hard outcomes was found, but angina relief was more effective in the revascularization group.","[{'ForeName': 'Amina', 'Initials': 'A', 'LastName': 'Rakisheva', 'Affiliation': 'Department of Cardiology, Friedrich Alexander University Erlangen-Nürnberg (FAU); Erlangen-Germany.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Marwan', 'Affiliation': 'Department of Cardiology, Friedrich Alexander University Erlangen-Nürnberg (FAU); Erlangen-Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Achenbach', 'Affiliation': 'Department of Cardiology, Friedrich Alexander University Erlangen-Nürnberg (FAU); Erlangen-Germany.'}]",Anatolian journal of cardiology,['10.14744/AnatolJCardiol.2020.82428'] 765,32623088,Effectiveness of Intramuscular Electrical Stimulation on Postsurgical Nociceptive Pain for Patients Undergoing Open Pancreaticoduodenectomy: A Randomized Clinical Trial.,"BACKGROUND After pylorus-preserving pancreaticoduodenectomy (PPPD), incision and suture of the abdominal muscles cause inflammatory changes and elicit somatic pain that deteriorates the quality of life. There have been no previous reports on needle electrical twitch obtaining intramuscular stimulation (NETOIMS) in abdominal open operation; this study aimed to apply NETOIMS for postoperative somatic pain in patients undergoing PPPD as a new treatment modality for pain control. METHODS Between June 2018 and January 2019, 44 patients who underwent PPPD were randomly assigned to a control group and the NETOIMS group. The NETOIMS group received NETOIMS in the transverse abdominis muscle under ultrasound guidance right after operation under general anesthesia. The pain score (visual analog scale), peak cough flow (PCF), and gait speed were repetitively measured from 1 day before operation to 2 weeks after discharge as scheduled. Data were analyzed by the linear mixed model and repeated-measures analysis of variance. RESULTS Of the 44 patients recruited, data from 38 patients were finally analyzed. The pain scores were significantly lower in the NETOIMS group after PPPD (p = 0.01). Although the PCF at each measuring time point did not show inter-group difference (p = 0.20), improvement of PCF from the second day after operation to discharge was greater (p = 0.02) and gait speed improved significantly faster (p < 0.01) in the NETOIMS group than in the control group. CONCLUSIONS NETOIMS helps in rapid reduction of postoperative somatic pain developed after PPPD and in improvement of PCF and gait speed.",2020,"Although the PCF at each measuring time point did not show inter-group difference (P = 0.20), improvement of PCF from the second day of surgery to discharge was greater (P = 0.02) and gait speed improved significantly faster (P < 0.01) in the NETOIMS group than in the control group. ","['44 patients recruited, data of 38 patients were finally analyzed', 'Patients Undergoing Open Pancreaticoduodenectomy', 'after surgery under general anesthesia', 'Between June 2018 and January 2019, 44 patients who underwent PPPD', 'patients undergoing PPPD as a new treatment modality for pain control']","['transverse abdominis muscle under ultrasound guidance right', 'Intramuscular Electrical Stimulation']","['pain scores', 'gait speed', 'PCF and gait speed', 'Postsurgical Nociceptive Pain', 'improvement of PCF', 'pain score (visual analog scale, VAS), peak cough flow (PCF), and gait speed']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C3178766', 'cui_str': 'Nociceptive Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",38.0,0.0740017,"Although the PCF at each measuring time point did not show inter-group difference (P = 0.20), improvement of PCF from the second day of surgery to discharge was greater (P = 0.02) and gait speed improved significantly faster (P < 0.01) in the NETOIMS group than in the control group. ","[{'ForeName': 'Jinyoung', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Rehabilitation Institute of Neuromuscular Disease, Department of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyung Sun', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Pancreatobiliary Cancer Clinic, Department of Surgery, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jung Hyun', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Rehabilitation Institute of Neuromuscular Disease, Department of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yoon Ghil', 'Initials': 'YG', 'LastName': 'Park', 'Affiliation': 'Rehabilitation Institute of Neuromuscular Disease, Department of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sanghoon', 'Initials': 'S', 'LastName': 'Shin', 'Affiliation': 'Gangnam Severance Hospital, Department Rehabilitation Medicine, Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jae Eun', 'Initials': 'JE', 'LastName': 'Park', 'Affiliation': 'Gangnam Severance Hospital, Department Rehabilitation Medicine, Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sangwon', 'Initials': 'S', 'LastName': 'Hwang', 'Affiliation': 'Gangnam Severance Hospital, Department Rehabilitation Medicine, Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'So Young', 'Initials': 'SY', 'LastName': 'Jun', 'Affiliation': 'Pancreatobiliary Cancer Clinic, Department of Surgery, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Joon Seong', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Pancreatobiliary Cancer Clinic, Department of Surgery, Yonsei University College of Medicine, Seoul, Republic of Korea. Electronic address: jspark330@yuhs.ac.'}]",Journal of the American College of Surgeons,['10.1016/j.jamcollsurg.2020.06.008'] 766,32628030,Leveraging goals to incentivize healthful behaviors across adulthood.,"Despite abundant evidence for the benefits of physical activity on aging trajectories, older Americans remain largely inactive. The present study was designed to examine age differences in responsiveness to financial incentives to increase walking. Grounded in socioemotional selectivity theory, we examined the effectiveness of financial incentives that varied in prosociality. Three types of incentives were presented to community-residing adults 18-92 years of age ( N = 450). Participants were randomly assigned to 1 of 5 conditions: personal, loved one, charity, choice, or a no-incentive control group. Average daily step counts were measured using pedometers during a baseline week, during the incentivized period, and after the incentivized period ended. Overall, financial incentives significantly increased walking compared to a control group. Whereas personal incentives were effective regardless of age, incentives to earn for charities were starkly more effective in older adults than younger adults. Moreover, 1 week after the incentivized period ended, older participants were more likely to maintain increased step counts, whereas younger people reverted to baseline step counts. Findings suggest that financial incentives can increase walking in a wide age range and that charitable incentives may be especially effective in health interventions targeting older adults. The importance of aligning incentives with age-related goals is discussed. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"Overall, financial incentives significantly increased walking compared to a control group.","['Three types of incentives were presented to community-residing adults 18-92 years of age ( N = 450', 'older adults than younger adults']","['5 conditions: personal, loved one, charity, choice, or a no-incentive control group']",['Average daily step counts'],"[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0024028', 'cui_str': 'Love'}, {'cui': 'C0007962', 'cui_str': 'Charities'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",,0.0370805,"Overall, financial incentives significantly increased walking compared to a control group.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Raposo', 'Affiliation': 'Department of Psychology, Stanford University.'}, {'ForeName': 'Candice L', 'Initials': 'CL', 'LastName': 'Hogan', 'Affiliation': 'Department of Psychology, Stanford University.'}, {'ForeName': 'Jessica T', 'Initials': 'JT', 'LastName': 'Barnes', 'Affiliation': 'Department of Psychology, Stanford University.'}, {'ForeName': 'Teja', 'Initials': 'T', 'LastName': 'Chemudupati', 'Affiliation': 'Department of Psychology, Stanford University.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Carstensen', 'Affiliation': 'Department of Psychology, Stanford University.'}]",Psychology and aging,['10.1037/pag0000428'] 767,32624375,Effectiveness of ginger on pain following periodontal surgery - A randomized cross-over clinical trial.,"BACKGROUND Ibuprofen is one of the generally prescribed Non-steroidal anti-inflammatory drugs (NSAIDs) for postoperative pain after periodontal surgery, but are contraindicated in certain patients. Ginger, which is the rhizome of Zingiber officinale, being a common herbal drug having anti-inflammatory as well as analgesic activities can be an efficient substitute for synthetic agents like Ibuprofen. OBJECTIVES To compare the effectiveness of ibuprofen and dried ginger powder on pain and gingival inflammation following open flap debridement. MATERIALS AND METHODS Ten systemically healthy individuals with chronic generalized periodontitis were selected for this single-blinded randomized cross-over clinical trial and underwent open flap debridement in at least two quadrants. Each quadrant was randomly allocated to receive either Ibuprofen (400 mg) or Ginger powder capsules (400 mg) thrice daily for three days. Subjects were requested to note down the pain score on the Visual Analogue Scale (VAS) provided in a printed format, for the first eight hours after surgery and on the following two days, and gingival inflammation was assessed after one week, using Modified Gingival Index (MGI). RESULT The difference in the VAS score and MGI between the two groups was not of statistical significance. CONCLUSION Effectiveness of ginger powder for the management of pain and gingival inflammation following open flap debridement is comparable to that of ibuprofen.",2021,Effectiveness of ginger powder for the management of pain and gingival inflammation following open flap debridement is comparable to that of ibuprofen.,['Ten systemically healthy individuals with chronic generalized periodontitis'],"['ibuprofen', 'ibuprofen and dried ginger powder', 'Ginger powder capsules', 'Ibuprofen', 'ginger', 'ginger powder', 'open flap debridement']","['pain and gingival inflammation', 'pain score on the Visual Analogue Scale (VAS', 'VAS score and MGI', 'pain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0162751', 'cui_str': 'Ginger'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}]",10.0,0.224003,Effectiveness of ginger powder for the management of pain and gingival inflammation following open flap debridement is comparable to that of ibuprofen.,"[{'ForeName': 'Pallavi', 'Initials': 'P', 'LastName': 'Menon', 'Affiliation': 'Department of Periodontics, Amrita School of Dentistry, Kochi, Amrita Vishwa Vidyapeetham, India. Electronic address: menon.pallavi.92@gmail.com.'}, {'ForeName': 'Jayachandran', 'Initials': 'J', 'LastName': 'Perayil', 'Affiliation': 'Department of Periodontics, Amrita School of Dentistry, Kochi, Amrita Vishwa Vidyapeetham, India.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Fenol', 'Affiliation': 'Department of Periodontics, Amrita School of Dentistry, Kochi, Amrita Vishwa Vidyapeetham, India.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Rajan Peter', 'Affiliation': 'Department of Periodontics, Amrita School of Dentistry, Kochi, Amrita Vishwa Vidyapeetham, India.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lakshmi', 'Affiliation': 'Department of Periodontics, Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'Reshma', 'Initials': 'R', 'LastName': 'Suresh', 'Affiliation': 'Department of Periodontics, Amrita School of Dentistry, Kochi, Amrita Vishwa Vidyapeetham, India.'}]",Journal of Ayurveda and integrative medicine,['10.1016/j.jaim.2020.05.003'] 768,32624429,Effect of Prior Formal Education on Successful Thoracic Epidural Placement By Anesthesia Residents.,"OBJECTIVE Catheter placement for thoracic epidural analgesia (TEA) is technically challenging; however, methods for teaching this technique to anesthesia residents have not been well-studied. The present study aimed to determine optimal teaching methods for proficient TEA catheter placement by comparing video-based formal resident education with traditional bedside training by attending physicians. DESIGN Prospective, randomized study. SETTING Large academic hospital, single institution. PARTICIPANTS The study comprised 76 postgraduate year 3 and 4 anesthesiology residents (38 intervention, 38 control). INTERVENTIONS Formal education included an instructional video on proper TEA technique. MEASUREMENTS AND MAIN RESULTS Measures of proficiency in TEA catheter placement included the time needed to complete the procedure successfully and the success of placement as indicated by patient confirmation. Residents who received formal video instruction had similar success in catheter placement and similar procedure times compared with the traditionally trained residents. The overall success rate was 99.2%, with faculty intervention required in only 17% of cases. More experienced residents (ie, having placed more epidural catheters) were faster at TEA catheter placement. CONCLUSIONS Formal video education for TEA catheter placement provided no additional improvement of resident proficiency compared with traditional training at a high-volume academic center. The success rate was very high in this group of residents; however, experiences at other institutions may vary. Future studies are needed to determine optimum teaching strategies for TEA.",2020,Residents who received formal video instruction had similar success in catheter placement and similar procedure times compared with the traditionally trained residents.,"['Large academic hospital, single institution', 'The study comprised 76 postgraduate year 3 and 4 anesthesiology residents (38 intervention, 38 control', 'Successful Thoracic Epidural Placement By Anesthesia Residents']","['Prior Formal Education', 'Formal education included an instructional video on proper TEA technique', 'TEA catheter placement', 'proficient TEA catheter placement by comparing video-based formal resident education with traditional bedside training', 'Catheter placement for thoracic epidural analgesia (TEA', 'formal video instruction']","['time needed to complete the procedure successfully and the success of placement', 'success rate', 'overall success rate']","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0883301', 'cui_str': 'Catheter placement'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.072334,Residents who received formal video instruction had similar success in catheter placement and similar procedure times compared with the traditionally trained residents.,"[{'ForeName': 'Yar Luan', 'Initials': 'YL', 'LastName': 'Yeap', 'Affiliation': 'Department of Anesthesia, Indiana University School of Medicine, Indianapolis, IN. Electronic address: yyeap@iupui.edu.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Randolph', 'Affiliation': 'Anesthesia Consultants Of Indianapolis, Indianapolis, IN.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Lemmon', 'Affiliation': 'Department of Anesthesia, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Miles D', 'Initials': 'MD', 'LastName': 'Mann', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Stewart', 'Affiliation': 'Department of Anesthesia, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Wolfe', 'Affiliation': 'Department of Anesthesia, Indiana University School of Medicine, Indianapolis, IN.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.06.023'] 769,32635933,Stepped-wedge cluster randomised trial of a smoking cessation counselling training programme for midwives treating women with functional health illiteracy and low socioeconomic status (PROMISE): a study protocol.,"BACKGROUND In the Netherlands, midwives are required to use the 'V-MIS' (Minimal Intervention Strategy for Midwives) smoking cessation counselling protocol to help pregnant women quit smoking. This counselling protocol is often poorly implemented in midwifery practices. It may also be less suitable for pregnant woman with low socioeconomic status or functional health illiteracy. We created an adapted version of the V-MIS protocol that is intended to facilitate implementation in midwifery practices: PROMISE (PROtocol for growing up smokefree using a Minimal smoking cessation Intervention Strategy in the Early stages of life). For this adapted protocol, midwives use carbon monoxide meters, storyboard leaflets, and specific communication techniques for women with functional health illiteracy. They will receive a face-to-face training in using these materials and communication techniques. METHODS The effectiveness and implementation of PROMISE will be tested in a stepped-wedge cluster randomised controlled trial. We will randomise clusters of midwifery practices and departments in hospitals. We will then train them, subsequently, at regular intervals ('steps'). At each step, practices that will receive training cross over from the control condition to the experimental condition. We will measure how well the PROMISE protocol has been implemented by assessing the rate of pregnant women that received detailed smoking cessation counselling from their midwives (primary outcome). Our secondary target group is pregnant women with functional health illiteracy and low socioeconomic status. Among them, we will assess smoking status and health-related outcome before and after pregnancy. DISCUSSION The PROMISE smoking cessation counselling protocol is intended to help midwives, OB-GYNs, and other obstetrics professionals to support pregnant women with smoking cessation. TRIAL REGISTRATION Dutch Trial Registry: NTR 6305/NL6158 . Registered on 20 December 2016.",2020,"The PROMISE smoking cessation counselling protocol is intended to help midwives, OB-GYNs, and other obstetrics professionals to support pregnant women with smoking cessation. ","['midwives treating women with functional health illiteracy and low socioeconomic status (PROMISE', 'pregnant women with functional health illiteracy and low socioeconomic status', 'pregnant women that received detailed smoking cessation counselling from their midwives (primary outcome', 'women with functional health illiteracy', 'pregnant women with smoking cessation', 'pregnant woman with low socioeconomic status or functional health illiteracy', 'midwifery practices and departments in hospitals']","[""MIS' (Minimal Intervention Strategy for Midwives) smoking cessation counselling protocol"", 'smoking cessation counselling training programme']",[],"[{'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0020899', 'cui_str': 'Illiteracy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],,0.125279,"The PROMISE smoking cessation counselling protocol is intended to help midwives, OB-GYNs, and other obstetrics professionals to support pregnant women with smoking cessation. ","[{'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Bommelé', 'Affiliation': 'Trimbos Institute, The Netherlands Expertise Centre for Tobacco Control, Utrecht, the Netherlands. jbommele@trimbos.nl.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Springvloet', 'Affiliation': 'Trimbos Institute, The Netherlands Expertise Centre for Tobacco Control, Utrecht, the Netherlands.'}, {'ForeName': 'Naïma', 'Initials': 'N', 'LastName': 'Abouri', 'Affiliation': 'Pharos, Utrecht, the Netherlands.'}, {'ForeName': 'Karianne', 'Initials': 'K', 'LastName': 'Djoyoadhiningrat-Hol', 'Affiliation': 'Lung Foundation Netherlands, Amersfoort, the Netherlands.'}, {'ForeName': 'Margriet', 'Initials': 'M', 'LastName': 'van Laar', 'Affiliation': 'Trimbos Institute, The Netherlands Expertise Centre for Tobacco Control, Utrecht, the Netherlands.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Blankers', 'Affiliation': 'Trimbos Institute, The Netherlands Expertise Centre for Tobacco Control, Utrecht, the Netherlands.'}]",Trials,['10.1186/s13063-020-04555-0'] 770,32629078,Knowledge-Based Assessment of Focal Dose Escalation Treatment Plans in Prostate Cancer.,"PURPOSE In a randomized focal dose escalation radiation therapy trial for prostate cancer (FLAME), up to 95 Gy was prescribed to the tumor in the dose-escalated arm, with 77 Gy to the entire prostate in both arms. As dose constraints to organs at risk had priority over dose escalation and suboptimal planning could occur, we investigated how well the dose to the tumor was boosted. We developed an anatomy-based prediction model to identify plans with suboptimal tumor dose and performed replanning to validate our model. METHODS AND MATERIALS We derived dose-volume parameters from planned dose distributions of 539 FLAME trial patients in 4 institutions and compared them between both arms. In the dose-escalated arm, we determined overlap volume histograms and derived features representing patient anatomy. We predicted tumor D98% with a linear regression on anatomic features and performed replanning on 21 plans. RESULTS In the dose-escalated arm, the median tumor D50% and D98% were 93.0 and 84.7 Gy, and 99% of the tumors had a dose escalation greater than 82.4 Gy (107% of 77 Gy). In both arms organs at risk constraints were met. Five out of 73 anatomic features were found to be predictive for tumor D98%. Median predicted tumor D98% was 4.4 Gy higher than planned D98%. Upon replanning, median tumor D98% increased by 3.0 Gy. A strong correlation between predicted increase in D98% and realized increase upon replanning was found (ρ = 0.86). CONCLUSIONS Focal dose escalation in prostate cancer was feasible with a dose escalation to 99% of the tumors. Replanning resulted in an increased tumor dose that correlated well with the prediction model. The model was able to identify tumors on which a higher boost dose could be planned. The model has potential as a quality assessment tool in focal dose escalated treatment plans.",2020,Replanning resulted in an increased tumor dose that correlated well with the prediction model.,"['539 [X] patients in 4 institutions and compared them between both arms', 'prostate cancer']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]",[],[],,0.0291957,Replanning resulted in an increased tumor dose that correlated well with the prediction model.,"[{'ForeName': 'Marcel A', 'Initials': 'MA', 'LastName': 'van Schie', 'Affiliation': 'Netherlands Cancer Institute, Radiation Oncology, Amsterdam, The Netherlands. Electronic address: m.v.schie@nki.nl.'}, {'ForeName': 'Tomas M', 'Initials': 'TM', 'LastName': 'Janssen', 'Affiliation': 'Netherlands Cancer Institute, Radiation Oncology, Amsterdam, The Netherlands.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Eekhout', 'Affiliation': 'Netherlands Cancer Institute, Radiation Oncology, Amsterdam, The Netherlands.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Walraven', 'Affiliation': 'Netherlands Cancer Institute, Radiation Oncology, Amsterdam, The Netherlands.'}, {'ForeName': 'Floris J', 'Initials': 'FJ', 'LastName': 'Pos', 'Affiliation': 'Netherlands Cancer Institute, Radiation Oncology, Amsterdam, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'de Ruiter', 'Affiliation': 'Netherlands Cancer Institute, Radiation Oncology, Amsterdam, The Netherlands.'}, {'ForeName': 'Alexis N T J', 'Initials': 'ANTJ', 'LastName': 'Kotte', 'Affiliation': 'University Medical Center Utrecht, Radiation Oncology, Utrecht, The Netherlands.'}, {'ForeName': 'Evelyn M', 'Initials': 'EM', 'LastName': 'Monninkhof', 'Affiliation': 'University Medical Center Utrecht, Radiation Oncology, Utrecht, The Netherlands.'}, {'ForeName': 'Linda G W', 'Initials': 'LGW', 'LastName': 'Kerkmeijer', 'Affiliation': 'University Medical Center Utrecht, Radiation Oncology, Utrecht, The Netherlands; Radboud University Medical Center, Radiation Oncology, Nijmegen, The Netherlands.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Draulans', 'Affiliation': 'University Hospitals Leuven, Radiation Oncology, Leuven, Belgium.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'de Roover', 'Affiliation': 'University Hospitals Leuven, Radiation Oncology, Leuven, Belgium.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Haustermans', 'Affiliation': 'University Hospitals Leuven, Radiation Oncology, Leuven, Belgium.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Kunze-Busch', 'Affiliation': 'Radboud University Medical Center, Radiation Oncology, Nijmegen, The Netherlands.'}, {'ForeName': 'Robert Jan', 'Initials': 'RJ', 'LastName': 'Smeenk', 'Affiliation': 'Radboud University Medical Center, Radiation Oncology, Nijmegen, The Netherlands.'}, {'ForeName': 'Uulke A', 'Initials': 'UA', 'LastName': 'van der Heide', 'Affiliation': 'Netherlands Cancer Institute, Radiation Oncology, Amsterdam, The Netherlands.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.06.072'] 771,32632732,Adapted ERAS Pathway Versus Standard Care in Patients Undergoing Emergency Small Bowel Surgery: a Randomized Controlled Trial.,"BACKGROUND Emergency laparotomy for small bowel pathologies comprises a significant number of all emergency surgeries. Application of evidence-based adapted enhanced recovery after surgery (ERAS) protocol can potentially improve the perioperative outcome in these procedures. AIMS To determine the feasibility, safety, and efficacy of adapted ERAS pathway in emergency small bowel surgery. METHODOLOGY This was a single-center, prospective, open-labeled, superiority, randomized controlled trial. Patients suspected to have small bowel pathology by the emergency surgical team were randomized preoperatively into standard care and adapted ERAS group. Patients with American Society of Anesthesiologist class ≥ 3, polytrauma patients with associated other intra-abdominal organ injuries, duodenal ulcer perforations, patients presenting with refractory shock, and pregnant patients were excluded. Primary outcome parameter was the length of hospitalization (LOH). Morbidity and other functional recovery parameters were also assessed. RESULTS Thirty-five patients were included in the adapted ERAS and standard care group. The laboratory and demographic variables were comparable. Patients in the ERAS group had significantly earlier recovery (days) in terms of first fluid diet (1.48 ± 0.18, p < 0.001), solid diet (2.11 ± 0.17, p < 0.001), time to first flatus (1.25 ± 0.24, p < 0.001), and first stool (1.8 ± 0.27, p < 0.001). Postoperative nausea, vomiting (RR 0.69, p = 0.19), pulmonary complications (RR 0.38, p = 0.16), superficial (RR 0.79, p = 0.33), and deep surgical site infections (RR 0.65, p = 0.39) were similar. Compared with the standard care group, ERAS group had significantly shorter LOH (8 ± 0.38 vs. 10.83 ± 0.42; Mean difference, 2.83 ± 0.56; p < 0.001). CONCLUSION Adapted ERAS pathways are feasible, safe, and significantly reduces the LOH in select patients undergoing emergency small bowel surgery.",2020,"CONCLUSION Adapted ERAS pathways are feasible, safe, and significantly reduces the LOH in select patients undergoing emergency small bowel surgery.","['Patients with American Society of Anesthesiologist class ≥\u20093, polytrauma patients with associated other intra-abdominal organ injuries, duodenal ulcer perforations, patients presenting with refractory shock, and pregnant patients were excluded', 'Patients Undergoing Emergency Small Bowel Surgery', 'Patients suspected to have small bowel pathology by the emergency surgical team', 'Thirty-five patients were included in the adapted ERAS and standard care group', 'patients undergoing emergency small bowel surgery']","['Adapted ERAS Pathway Versus Standard Care', 'standard care and adapted ERAS', 'ERAS']","['time to first flatus', 'feasibility, safety, and efficacy', 'shorter LOH', 'Morbidity and other functional recovery parameters', 'pulmonary complications', 'length of hospitalization (LOH', 'deep surgical site infections', 'earlier recovery', 'Postoperative nausea, vomiting']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0026771', 'cui_str': 'Multiple injuries'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1512911', 'cui_str': 'Intraabdominal route'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0740401', 'cui_str': 'Duodenal ulcer with perforation'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0349412', 'cui_str': 'Refractory shock'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0192571', 'cui_str': 'Operative procedure on small intestine'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",35.0,0.126187,"CONCLUSION Adapted ERAS pathways are feasible, safe, and significantly reduces the LOH in select patients undergoing emergency small bowel surgery.","[{'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Saurabh', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, 605006, India.'}, {'ForeName': 'Sathasivam', 'Initials': 'S', 'LastName': 'Sureshkumar', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, 605006, India.'}, {'ForeName': 'Subair', 'Initials': 'S', 'LastName': 'Mohsina', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, 605006, India.'}, {'ForeName': 'Thulasingam', 'Initials': 'T', 'LastName': 'Mahalakshmy', 'Affiliation': 'Department of Preventive Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, 605006, India.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Kundra', 'Affiliation': 'Anesthesia and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, 605006, India.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Kate', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, 605006, India. drvikramkate@gmail.com.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-020-04684-6'] 772,32631211,Perceived male partner attitudes toward the female condom predict female university students' use of the female condom.,"Female and male condoms are the only methods that prevent both sexually transmitted infections (STIs), including HIV, and unintended pregnancy. Despite continuing high STI rates, few studies investigate factors predicting whether women initiating female condom (FC) use sustain use. Using data from a randomized trial, we examined predictors of sustained FC use at five-month follow-up (FU2) among female university students in South Africa who participated in either a one-session, information-only, group-delivered Minimal Intervention or a two-session, group-delivered Enhanced Intervention . In the final multiple logistic regression model, believing one's partner holds positive attitudes toward the FC (aOR = 1.40; p = 0.028), and greater FC use for vaginal sex at previous assessment (aOR) = 1.19; p = 0.008) were associated with greater odds of FC use at FU2. Excluding number of FC-protected occasions at FU1 from the analysis, discussing FC use with partner (aOR = 2.89; p = 0.071) and believing one's partner holds positive attitudes toward the FC (aOR = 1.63; p < 0.001) were associated with greater odds of use at FU2. The FC empowers women to protect themselves from both STIs and unintended pregnancy, but targeted interventions are needed to address men's negative attitudes toward the device. Engaging men as FC champions to support and promote FC use, along with marketing campaigns targeted to men, may expand FC coverage and enhance uptake.",2020,"The FC empowers women to protect themselves from both STIs and unintended pregnancy, but targeted interventions are needed to address men's negative attitudes toward the device.","[""Perceived male partner attitudes toward the female condom predict female university students' use of the female condom"", 'female university students in South Africa who participated in either a one-session, information-only, group-delivered', 'Female and male condoms']","['sustained FC use at five-month follow-up (FU2', 'Minimal Intervention or a two-session, group-delivered Enhanced Intervention ']",[],"[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0221829', 'cui_str': 'Female condom'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],1.0,0.0216513,"The FC empowers women to protect themselves from both STIs and unintended pregnancy, but targeted interventions are needed to address men's negative attitudes toward the device.","[{'ForeName': 'Joanne E', 'Initials': 'JE', 'LastName': 'Mantell', 'Affiliation': 'Department of Psychiatry, Division of Gender, Sexuality and HIV, HIV Center for Clinical and Behavioral Studies, New York State Psychiatric Institute and Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Exner', 'Affiliation': 'Department of Psychiatry, Division of Gender, Sexuality and HIV, HIV Center for Clinical and Behavioral Studies, New York State Psychiatric Institute and Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Bai', 'Affiliation': 'Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Cheng-Shiun', 'Initials': 'CS', 'LastName': 'Leu', 'Affiliation': 'Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Mags', 'Initials': 'M', 'LastName': 'Beksinska', 'Affiliation': 'MRU (MatCH Research Unit), Department of Obstetrics & Gynaecology, The University of the Witwatersrand, Durban, South Africa.'}, {'ForeName': 'Zonke', 'Initials': 'Z', 'LastName': 'Mabude', 'Affiliation': 'MRU (MatCH Research Unit), Department of Obstetrics & Gynaecology, The University of the Witwatersrand, Durban, South Africa.'}, {'ForeName': 'Susie', 'Initials': 'S', 'LastName': 'Hoffman', 'Affiliation': 'Department of Psychiatry, Division of Gender, Sexuality and HIV, HIV Center for Clinical and Behavioral Studies, New York State Psychiatric Institute and Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Smit', 'Affiliation': 'MRU (MatCH Research Unit), Department of Obstetrics & Gynaecology, The University of the Witwatersrand, Durban, South Africa.'}]",International journal of STD & AIDS,['10.1177/0956462420912986'] 773,32628771,Biopsy outperforms reflectance confocal microscopy in diagnosing and subtyping basal cell carcinoma: results and experiences from a randomized controlled multicentre trial.,"BACKGROUND Reflectance confocal microscopy (RCM) is a noninvasive method for skin assessment, allowing entire lesion evaluation up to the papillary dermis. RCM is a potentially attractive alternative to punch biopsy (PB) in basal cell carcinoma (BCC). OBJECTIVES To determine the diagnostic accuracy of RCM vs. PB in diagnosing and subtyping BCC, and to study patient satisfaction and preferences. METHODS Patients with a clinically suspected primary BCC were randomized between RCM and biopsy. Conventional surgical excision or follow-up were used as reference. Sensitivity and specificity for BCC diagnosis and subtyping were calculated for both methods. BCC subtype was stratified based on clinical relevance: aggressive (infiltrative/micronodular) vs. nonaggressive (superficial/nodular) histopathological subtype and superficial vs. nonsuperficial BCC. Data on patient satisfaction and preferences were collected using a questionnaire and a contingent valuation method. RESULTS Sensitivity for BCC diagnosis was high and similar for both methods (RCM 99·0% vs. biopsy 99·0%; P = 1·0). Specificity for BCC diagnosis was lower for RCM (59·1% vs. 100·0%; P < 0·001). Sensitivity for aggressive BCC subtypes was lower for RCM (33·3% vs. 77·3%; P = 0·003). Sensitivity for nonsuperficial BCC was not significantly different (RCM 88·9% vs. biopsy 91·0%; P = 0·724). Patient satisfaction and preferences were good and highly comparable for both methods. CONCLUSIONS Biopsy outperforms RCM in diagnosing and subtyping clinically suspected primary BCC. This outcome does not support routine clinical implementation of RCM, as a replacement for PBs in this patient group.",2021,"Specificity for BCC diagnosis was lower with RCM (59.1% versus 100.0%, p<0.001).",['Patients with a clinically suspected primary BCC'],"['RCM', 'Biopsy Outperforms Reflectance Confocal Microscopy', 'Reflectance confocal microscopy (RCM', 'Conventional surgical excision', 'RCM and biopsy']","['diagnostic accuracy of RCM', 'Sensitivity and specificity for BCC diagnosis and subtyping', 'patient satisfaction and preferences', 'Sensitivity for non-superficial BCC', 'Specificity for BCC diagnosis', 'Sensitivity for BCC diagnosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0007117', 'cui_str': 'Basal cell carcinoma'}]","[{'cui': 'C0242842', 'cui_str': 'Confocal Microscopy'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0728940', 'cui_str': 'Excision'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0242842', 'cui_str': 'Confocal Microscopy'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0007117', 'cui_str': 'Basal cell carcinoma'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0862889', 'cui_str': 'Superficial basal cell carcinoma'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}]",,0.112967,"Specificity for BCC diagnosis was lower with RCM (59.1% versus 100.0%, p<0.001).","[{'ForeName': 'W', 'Initials': 'W', 'LastName': 'Woliner-van der Weg', 'Affiliation': 'Departments of, Department of, Dermatology, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Peppelman', 'Affiliation': 'Departments of, Department of, Dermatology, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Y S', 'Initials': 'YS', 'LastName': 'Elshot', 'Affiliation': 'Department of Dermatology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Visch', 'Affiliation': 'Department of Dermatology, Rijnstate Hospital, Arnhem, the Netherlands.'}, {'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Crijns', 'Affiliation': 'Department of Dermatology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'H A C', 'Initials': 'HAC', 'LastName': 'Alkemade', 'Affiliation': 'Department of Dermatology, Canisius Wilhelmina Hospital, Nijmegen, the Netherlands.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Bronkhorst', 'Affiliation': 'Department of, Health Evidence, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Adang', 'Affiliation': 'Department of, Health Evidence, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Amir', 'Affiliation': 'Department of, Pathology, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'M J P', 'Initials': 'MJP', 'LastName': 'Gerritsen', 'Affiliation': 'Departments of, Department of, Dermatology, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'P E J', 'Initials': 'PEJ', 'LastName': 'van Erp', 'Affiliation': 'Departments of, Department of, Dermatology, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'S F K', 'Initials': 'SFK', 'LastName': 'Lubeek', 'Affiliation': 'Departments of, Department of, Dermatology, Radboud University Medical Centre, Nijmegen, the Netherlands.'}]",The British journal of dermatology,['10.1111/bjd.19381'] 774,32632364,Videogame intervention to encourage HIV testing and counseling among adolescents.,"Background Adolescents in the United States account for one-fifth of new HIV cases, and have the highest rate of undiagnosed HIV, with more than half (51%) not knowing their status. It is a crucial public health concern to help equip youth with the information and autonomy to minimize their risk and know their status. Serious videogames are emerging as valuable tools for health and behavior change in adolescents, and have potential to engage this population and increase their use of HIV testing and counseling (HTC). The purpose of this study was to: (I) modify an original serious game targeting risk reduction and HIV prevention developed by the play2PREVENT Lab and create a new serious game that focuses on HTC; (II) evaluate its feasibility and acceptability; (III) pilot-test the assessment measures that are subsequently being used in a large randomized controlled trial. Methods Three focus groups with adolescents, aged 14-17 (n=13, mean age =15), informed artwork and storylines for PlayTest! After the game was completed, a pilot test was conducted using a one-group pretest-posttest design to collect data on: (I) participants' gameplay satisfaction and experience; (II) the validity of the project's assessments. Twenty-six participants, aged 15-16 were enrolled from a local after-school program. Participants played PlayTest! twice weekly for three weeks. Data were collected on behavior, intentions, knowledge, perceived susceptibility, and attitudes related to HTC at baseline, post-gameplay (three weeks), and follow-up (six weeks). Results For the focus groups used in the game development, four major themes emerged: (I) adolescents have strong misperceptions about HTC, including who should get tested and what the test entails; (II) adolescents have incorrect knowledge about how HIV is contracted, spread, and treated; (III) adolescents are supportive of their peers getting tested for HIV, but are not likely to get tested themselves; (IV) while the majority of adolescents know where to get tested for HIV, social stigma, misperceptions around HTC, and fear of having a positive diagnosis keep them from seeking it. For the pilot study, overall, participant experience with the game was highly favorable. The assessments were sensitive enough to capture changes in our target variables: intentions (P=0.037) and knowledge (P=0.025) related to HTC at follow-up. Conclusions The PlayTest! game provides promising results regarding using an engaging and evidence-informed videogame intervention to promote HTC in adolescents.",2020,"The assessments were sensitive enough to capture changes in our target variables: intentions (P=0.037) and knowledge (P=0.025) related to HTC at follow-up. ","['groups with adolescents, aged 14-17 (n=13, mean age =15), informed artwork and storylines for PlayTest', 'Twenty-six participants, aged 15-16 were enrolled from a local after-school program', 'adolescents', 'Participants played PlayTest']",['Videogame intervention'],"['behavior, intentions, knowledge, perceived susceptibility, and attitudes related to HTC']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0032214', 'cui_str': 'Play'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]",26.0,0.0406421,"The assessments were sensitive enough to capture changes in our target variables: intentions (P=0.037) and knowledge (P=0.025) related to HTC at follow-up. ","[{'ForeName': 'Tyra', 'Initials': 'T', 'LastName': 'Pendergrass', 'Affiliation': 'Yale Center for Health and Learning Games, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Hieftje', 'Affiliation': 'Department of Kinesiology and Physical Education, McGill University, Montreal, Canada.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Duncan', 'Affiliation': 'Yale Center for Health and Learning Games, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Fiellin', 'Affiliation': 'Yale Center for Health and Learning Games, Yale School of Medicine, New Haven, CT, USA.'}]",mHealth,['10.21037/mhealth.2020.01.05'] 775,32634486,Team clinic: Expansion of a multidisciplinary care model for adolescents with type 1 diabetes.,"BACKGROUND Adolescent and young adults (AYA) with Type 1 Diabetes (T1D) experience more difficulty with glycemic control than patients in all other age groups. The shared medical appointment (SMA) model has been effective in multiple healthcare populations, but the feasibility and effectiveness of SMA in AYA patients with T1D is unclear. METHODS This research leverages the team's multidisciplinary expertise to develop an engaging intervention toolkit and test the implementation of the Team Clinic care model for the treatment of T1D among middle school adolescents in a large urban children's hospital serving an economically, racially and ethnically diverse population. In Phase 1, the team will manualize the Team Clinic care model into an engaging, age-appropriate educational and intervention toolkit. In Phase 2, the team will conduct a randomized clinical trial to test the feasibility and usability of the toolkit from the provider perspective (team member satisfaction; clinical efficiency; compliance with American Diabetes Association, American Association of Diabetes Educators, and California Children's Services standards; and payor-level cost data) and the preliminary efficacy of the intervention toolkit on patient- and family-level outcomes (attendance, acceptability/satisfaction with care, patient-level cost data, diabetes outcomes, diabetes family conflict, diabetes distress, and depression). DISCUSSION AYA patients with T1D often receive care in clinics and institutions with limited resources and time. This research tests the feasibility and efficacy of an innovative and potentially cost-effective SMA model to address the unique needs of underserved populations, while meeting national and state clinical standards. Trial registration The study is registered with ClinicalTrials.gov (Protocol Record: NCT04190368).",2020,"This research tests the feasibility and efficacy of an innovative and potentially cost-effective SMA model to address the unique needs of underserved populations, while meeting national and state clinical standards.","['Adolescent and young adults (AYA) with Type 1 Diabetes (T1D) experience more difficulty with glycemic control than patients in all other age groups', 'adolescents with type 1 diabetes', 'patients with T1D often receive care in clinics and institutions with limited resources and time', ""middle school adolescents in a large urban children's hospital serving an economically, racially and ethnically diverse population""]",[],"['patient- and family-level outcomes (attendance, acceptability/satisfaction with care, patient-level cost data, diabetes outcomes, diabetes family conflict, diabetes distress, and depression']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0233542', 'cui_str': 'Family conflict'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.0267749,"This research tests the feasibility and efficacy of an innovative and potentially cost-effective SMA model to address the unique needs of underserved populations, while meeting national and state clinical standards.","[{'ForeName': 'Sarah-Jeanne', 'Initials': 'SJ', 'LastName': 'Salvy', 'Affiliation': 'Research Center for Health Equity, Cedars-Sinai Medical Center, United States of America.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Ruelas', 'Affiliation': 'Keck School of Medicine, University of Southern California, United States of America.'}, {'ForeName': 'Shideh', 'Initials': 'S', 'LastName': 'Majidi', 'Affiliation': 'School of Medicine, University of Colorado Anschutz Medical Campus, United States of America.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Thomas', 'Affiliation': 'Booster Shot Media, United States of America.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Ashwal', 'Affiliation': 'Booster Shot Media, United States of America.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Reid', 'Affiliation': ""The Vision Center, Children's Hospital Los Angeles, United States of America.""}, {'ForeName': 'D Steven', 'Initials': 'DS', 'LastName': 'Fox', 'Affiliation': 'School of Pharmacy, University of Southern California, United States of America.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'McClain', 'Affiliation': 'School of Social Work, University of Southern California, United States of America.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Raymond', 'Affiliation': ""Center for Endocrinology, Diabetes, & Metabolism, Children's Hospital Los Angeles, United States of America. Electronic address: jraymond@chla.usc.edu.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106079'] 776,32641236,Adherence to postoperative thromboprophylactic medication among gynecologic oncology patients: A subanalysis.,"INTRODUCTION Venous thromboembolism (VTE) is a major cause of morbidity and mortality among gynecologic cancer patients, especially in the immediate postoperative period. We sought to identify patterns related with patient non-adherence to postoperative prophylactic anticoagulation. METHODS Participant data (N = 400) were reviewed from a previously conducted randomized controlled trial comparing the safety and efficacy of prophylactic postoperative anticoagulation with enoxaparin versus apixaban among gynecologic oncology patients. Variables hypothesized to be related to medication adherence were pre-selected by the study authors, and adherence was defined as missing ≤2 days of medication (4 pills or 2 injections) in 28 days postoperatively. For univariate comparisons and multivariate modeling, the threshold for statistical significance was set at p < .05. RESULTS Non-adherence (N = 64) was associated with lower quality of life (QOL) score, history of anxiety disorder, decreased medication satisfaction, taking more medications at baseline, higher baseline heart rate, fewer total intraoperative procedures, not undergoing radical hysterectomy and/or lymph node dissection, not meeting 2-week postoperative milestones, and 28-day emergency department (ED) visit or readmission. African American race, lower mental QOL, difficulty remembering to take medication, and 28-day ED visit or readmission were predictive of non-adherence in a multivariate model. Patients taking enoxaparin versus apixaban more frequently attributed non-adherence to pain or bruising (25.0% vs. 3.1%, P = .01). CONCLUSION Our findings provide new insights into factors associated with medication adherence that are particularly relevant to gynecologic oncology patients after surgery. Preoperative interventions to identify patients with these risk factors for more intensive followup of postoperative anticoagulation regimen may help increase medication adherence.",2020,"Non-adherence (N = 64) was associated with lower quality of life (QOL) score, history of anxiety disorder, decreased medication satisfaction, taking more medications at baseline, higher baseline heart rate, fewer total intraoperative procedures, not undergoing radical hysterectomy and/or lymph node dissection, not meeting 2-week postoperative milestones, and 28-day emergency department (ED) visit or readmission.","['gynecologic cancer patients', 'Participant data (N\xa0=\xa0400', 'gynecologic oncology patients']","['enoxaparin', 'prophylactic postoperative anticoagulation with enoxaparin versus apixaban']","['mental QOL, difficulty remembering to take medication, and 28-day ED visit or readmission', 'lower quality of life (QOL) score, history of anxiety disorder, decreased medication satisfaction, taking more medications at baseline, higher baseline heart rate, fewer total intraoperative procedures, not undergoing radical hysterectomy and/or lymph node dissection, not meeting 2-week postoperative milestones, and 28-day emergency department (ED) visit or readmission', 'adherence to pain or bruising', 'medication adherence']","[{'cui': 'C0699889', 'cui_str': 'Female reproductive neoplasm malignant NOS'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C1321164', 'cui_str': 'Gynecological oncology'}]","[{'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C1290952', 'cui_str': 'Taking medication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0243164', 'cui_str': 'peroperative procedures'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",400.0,0.05271,"Non-adherence (N = 64) was associated with lower quality of life (QOL) score, history of anxiety disorder, decreased medication satisfaction, taking more medications at baseline, higher baseline heart rate, fewer total intraoperative procedures, not undergoing radical hysterectomy and/or lymph node dissection, not meeting 2-week postoperative milestones, and 28-day emergency department (ED) visit or readmission.","[{'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Ross', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine Anschutz Medical Campus, Aurora, CO, USA. Electronic address: megan.ross@cuanschutz.edu.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Glickman', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Alyse', 'Initials': 'A', 'LastName': 'Brennecke', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tayebnejad', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Saketh R', 'Initials': 'SR', 'LastName': 'Guntupalli', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine Anschutz Medical Campus, Aurora, CO, USA.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.06.505'] 777,32641379,Impact of Acarbose on Incident Diabetes and Regression to Normoglycemia in People With Coronary Heart Disease and Impaired Glucose Tolerance: Insights From the ACE Trial.,"OBJECTIVE We examined the impact of acarbose, an α-glucosidase inhibitor, on incident diabetes and regression to normoglycemia in 6,522 Acarbose Cardiovascular Evaluation (ACE) trial participants in China who had impaired glucose tolerance (IGT) and coronary heart disease (CHD). RESEARCH DESIGN AND METHODS Participants were randomly assigned to acarbose or placebo and followed with four monthly fasting plasma glucose (FPG) tests and annual oral glucose tolerance tests. Incident diabetes was defined as two successive diagnostic FPG levels ≥7 mmol/L or 2-h plasma glucose (PG) levels ≥11.1 mmol/L while taking study medication or a masked adjudicated confirmation of this diagnosis. Regression to normoglycemia was defined as FPG <6.1 mmol/L and 2-h PG <7.8 mmol/L. Intention-to-treat and on-treatment analyses were conducted using Poisson regression models, overall and for subgroups (age, sex, CHD type, HbA 1c , FPG, 2-h PG, BMI, estimated glomerular filtration rate, for IGT alone, for IGT + impaired fasting glucose, and for use of thiazides, ACE inhibitors [ACEis]/angiotensin receptor blockers [ARBs], β-blockers, calcium channel blockers, or statins). RESULTS Incident diabetes was less frequent with acarbose compared with placebo (3.2 and 3.8 per 100 person-years, respectively; rate ratio 0.82 [95% CI 0.71, 0.94], P = 0.005), with no evidence of differential effects within the predefined subgroups after accounting for multiple testing. Regression to normoglycemia occurred more frequently in those randomized to acarbose compared with placebo (16.3 and 14.1 per 100 person-years, respectively; 1.16 [1.08, 1.25], P < 0.0001). This effect was greater in participants not taking an ACEi or ARB (1.36 [1.21, 1.53], P interaction = 0.0006). The likelihood of remaining in normoglycemic regression did not differ between the acarbose and placebo groups ( P = 0.41). CONCLUSIONS Acarbose reduced the incidence of diabetes and promoted regression to normoglycemia in Chinese people with IGT and CHD.",2020,"The likelihood of remaining in normoglycemic regression did not differ between the acarbose and placebo groups ( P = 0.41). ","['Chinese people with IGT and CHD', 'Participants', 'People With Coronary Heart Disease and Impaired Glucose Tolerance', '6,522 Acarbose Cardiovascular Evaluation trial participants in China who had impaired glucose tolerance (IGT) and coronary heart disease (CHD']","['acarbose', 'acarbose or placebo and followed with four monthly fasting plasma glucose (FPG) tests and annual oral glucose tolerance tests', 'Acarbose', 'placebo']","['likelihood of remaining in normoglycemic regression', 'diagnostic FPG levels ≥7 mmol/L or 2-h plasma glucose', 'Regression to normoglycemia', 'PG) levels']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0050393', 'cui_str': 'Acarbose'}, {'cui': 'C0948955', 'cui_str': 'Cardiovascular evaluation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0050393', 'cui_str': 'Acarbose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0580545', 'cui_str': 'Blood glucose normal'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}]",,0.176977,"The likelihood of remaining in normoglycemic regression did not differ between the acarbose and placebo groups ( P = 0.41). ","[{'ForeName': 'Hertzel C', 'Initials': 'HC', 'LastName': 'Gerstein', 'Affiliation': 'Department of Medicine and Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada gerstein@mcmaster.ca.'}, {'ForeName': 'Ruth L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'Diabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, U.K.'}, {'ForeName': 'Charles A B', 'Initials': 'CAB', 'LastName': 'Scott', 'Affiliation': 'Diabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, U.K.'}, {'ForeName': 'Shishi', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Diabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, U.K.'}, {'ForeName': 'Jaakko', 'Initials': 'J', 'LastName': 'Tuomilehto', 'Affiliation': 'Department of Public Health Solutions, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Rydén', 'Affiliation': 'Department of Medicine K2, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-2046'] 778,32631157,Tenecteplase versus alteplase after acute ischemic stroke at high age.,"BACKGROUND Stroke prevalence is increasing with age. Alteplase is the only agent approved for thrombolytic treatment for patients with ischemic stroke, including patients ≥80 years. In the present study, the aim was to compare efficacy and safety of tenecteplase and alteplase in patients ≥80 years. METHODS Data from the Norwegian Tenecteplase Stroke Trial, a randomized controlled trial comparing alteplase and tenecteplase, were assessed. RESULTS Of the 273 patients ≥80 years included, mean age was 85.5 years.In the intention-to-treat analyses, 43.1% receiving tenecteplase and 39.9% receiving alteplase reached excellent functional outcome (modified Rankin Scale score 0-1) after 3 months (odds ratio (OR) 1.14, 95% confidence interval (CI) 0.70-1.85, p=0.59). No significant differences among patients in the two treatment groups regarding frequency of symptomatic intracranial hemorrhage during the first 48 h were identified (11 (8.5%) in the tenecteplase group, 10 (7.0%) in the alteplase group, OR 1.23, 95% CI 0.50-3.00, p 0.65). Death within 3 months occurred in 18 patients (14.3%) in the tenecteplase group and in 21 (15.3%) in the alteplase group (p 0.84). After excluding stroke mimics, the proportion of patients with excellent functional outcome was 44.1% in the tenecteplase group and 34.4% in the alteplase group (OR 1.50 CI 0.90-2.52, p 0.12). CONCLUSION No differences in the efficacy and safety of tenecteplase versus alteplase in patients ≥80 years were identified. TRIAL REGISTRATION Clinicaltrials.gov (NCT01949948).",2021,"No significant differences among patients in the two treatment groups regarding frequency of symptomatic intracranial hemorrhage during the first 48 h were identified (11 (8.5%) in the tenecteplase group, 10 (7.0%) in the alteplase group, OR 1.23, 95% CI 0.50-3.00, p 0.65).","['patients with ischemic stroke, including patients ≥80 years', '≥80 years included, mean age was 85.5 years', 'patients ≥80 years were identified', '273 patients', 'Data from the Norwegian Tenecteplase Stroke Trial', 'patients ≥80 years']","['Alteplase', 'tenecteplase and alteplase', 'Tenecteplase versus alteplase']","['efficacy and safety', 'proportion of patients with excellent functional outcome', 'Death', 'frequency of symptomatic intracranial hemorrhage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0872913', 'cui_str': 'Tenecteplase'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0872913', 'cui_str': 'Tenecteplase'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}]",273.0,0.114169,"No significant differences among patients in the two treatment groups regarding frequency of symptomatic intracranial hemorrhage during the first 48 h were identified (11 (8.5%) in the tenecteplase group, 10 (7.0%) in the alteplase group, OR 1.23, 95% CI 0.50-3.00, p 0.65).","[{'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Thommessen', 'Affiliation': 'Department of Neurology, Division of Medicine, Akershus University Hospital, Lorenskog, Norway.'}, {'ForeName': 'Halvor', 'Initials': 'H', 'LastName': 'Næss', 'Affiliation': 'Department of Neurology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Logallo', 'Affiliation': 'Department of Neurosurgery, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Kvistad', 'Affiliation': 'Department of Neurology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Waje-Andreassen', 'Affiliation': 'Department of Neurology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Hege', 'Initials': 'H', 'LastName': 'Ihle-Hansen', 'Affiliation': 'Department of Internal Medicine, Bærum Hospital, Drammen, Norway.'}, {'ForeName': 'Håkon', 'Initials': 'H', 'LastName': 'Ihle-Hansen', 'Affiliation': 'Department of Internal Medicine, Bærum Hospital, Drammen, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Thomassen', 'Affiliation': 'Department of Neurology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Morten Rønning', 'Affiliation': 'Department of Neurology, Division of Medicine, Akershus University Hospital, Lorenskog, Norway.'}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493020938306'] 779,32634624,Effects of Screening Compliance on Long-term Reductions in All-Cause and Colorectal Cancer Mortality.,"BACKGROUND & AIMS Randomized trials have shown that biennial fecal occult blood test (FOBT) screening reduces mortality from colorectal cancer (CRC), but not overall mortality. Differences in benefit for men vs women, and by age, are unknown. We sought to evaluate long-term reduction in all-cause and CRC-specific mortality in men and women who comply with offered screening, and in different age groups, using individual participant data from 2 large randomized trials of biennial FOBT screening, compared with an intention to treat analysis. METHODS We updated the CRC and all-cause mortality from the Danish CRC screening trial (n = 61,933) through 30 years of follow up and pooled individual participant data with individual 30-year follow-up data from the Minnesota Colon Cancer Control trial (n = 46,551). We compared the biennial screening groups to usual care (controls) in individuals 50-80 years old using Kaplan Meier estimates of relative risks and risk differences, adjusted for study differences in age, sex, and compliance. RESULTS Through 30 years of follow up, there were 33,478 (71.9%) and 33,479 (72.2%) total deaths and 1023 (2.2%) and 1146 (2.5%) CRC deaths in the biennial screening (n = 46,553) and control groups (n = 46,358), respectively. Among compliers, biennial FOBT screening significantly reduced CRC mortality by 16% (relative risk [RR], 0.84; 95% CI, 0.74-0.96) and all-cause mortality by 2% (RR, 0.98; 95% CI, 0.97-0.99). Among compliers, the reduction in CRC mortality was larger for men (RR, 0.75; 95% CI, 0.62-0.90) than women (RR, 0.91; 95% CI, 0.75-1.09). The largest reduction in CRC mortality was in compliant men 60-69 years old (RR, 0.59; 95% CI, 0.42-0.81) and women 70 years and older (RR, 0.53; 95% CI, 0.30-0.94). CONCLUSIONS Long-term CRC mortality outcomes of screening among compliers using biennial FOBT are sustained, with a statistically significant reduction in all-cause mortality. The reduction in CRC mortality is greater in men than women-the benefit in women lags that of men by about 10 years.",2021,"Among compliers, the reduction in CRC mortality was larger for men (RR, 0.75; 95% CI, 0.62-0.90) than women (RR, 0.91; 95% CI, 0.75-1.09).","['men and women who comply with offered screening, and in different age groups']","['biennial screening groups to usual care (controls', 'biennial FOBT screening']","['total deaths', 'CRC mortality', 'CRC deaths', 'cause mortality', 'Colorectal Cancer Mortality']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0201811', 'cui_str': 'Screening for occult blood in feces'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",61933.0,0.195055,"Among compliers, the reduction in CRC mortality was larger for men (RR, 0.75; 95% CI, 0.62-0.90) than women (RR, 0.91; 95% CI, 0.75-1.09).","[{'ForeName': 'Aasma', 'Initials': 'A', 'LastName': 'Shaukat', 'Affiliation': 'Division of Gastroenterology, Minneapolis Veterans Affairs Healthcare System Minneapolis, Minnesota; Department of Medicine, University of Minnesota School of Medicine, Minneapolis, Minnesota; Division of Environmental Health Sciences, University of Minnesota School of Public Health, Minneapolis, Minnesota. Electronic address: shaukat@umn.edu.'}, {'ForeName': 'Lasse', 'Initials': 'L', 'LastName': 'Kaalby', 'Affiliation': 'Open Patient Data Explorative Network, Odense University Hospital and University of Southern Denmark, Odense, Denmark; Department of Clinical Research, University of Southern Denmark, Odense, Denmark; Department of Surgery, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Baatrup', 'Affiliation': 'Open Patient Data Explorative Network, Odense University Hospital and University of Southern Denmark, Odense, Denmark; Department of Clinical Research, University of Southern Denmark, Odense, Denmark; Department of Surgery, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Kronborg', 'Affiliation': 'Open Patient Data Explorative Network, Odense University Hospital and University of Southern Denmark, Odense, Denmark; Department of Clinical Research, University of Southern Denmark, Odense, Denmark; Department of Surgery, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Duval', 'Affiliation': 'Cardiovascular Division, University of Minnesota Medical School, Minneapolis, Minnesota.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Shyne', 'Affiliation': 'Division of Biostatistics, University of Minnesota School of Public Health, Minneapolis, Minnesota.'}, {'ForeName': 'Jack S', 'Initials': 'JS', 'LastName': 'Mandel', 'Affiliation': 'Division of Environmental Health Sciences, University of Minnesota School of Public Health, Minneapolis, Minnesota.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Church', 'Affiliation': 'Division of Environmental Health Sciences, University of Minnesota School of Public Health, Minneapolis, Minnesota.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.06.019'] 780,32640882,Atrial fibrillation trial to evaluate real-world procedures for their utility in helping to lower stroke events: A randomized clinical trial.,"BACKGROUND Enhancing detection of unrecognized atrial fibrillation among acute ischemic stroke patients is crucial for secondary stroke prevention. AIM To evaluate whether the detection rate of new atrial fibrillation in acute ischemic stroke patients without known atrial fibrillation could be improved by doing serial 12-lead electrocardiograms once daily for five days, compared with conventional 24-h Holter monitoring (24-h Holter). METHODS We conducted a randomized clinical trial to compare the detection rates of paroxysmal atrial fibrillation between serial electrocardiograms versus 24-h Holter from October 2015 to October 2018 at six hospitals. Eligible participants were acute ischemic stroke patients with aged ≥65 years, with neither atrial fibrillation history nor any presence of atrial fibrillation on baseline electrocardiogram at admission. The primary outcome was newly detected electrocardiogram in the serial electrocardiograms and 24-h Holter group. RESULTS Among 826 patients, baseline characteristics were similar between both groups. In the intention-to-treat analysis, there was no statistical difference between serial electrocardiograms versus 24-Holter to detect atrial fibrillation (8.4% vs. 6.9%; adjusted odds ratio 1.17, 95% confidence interval 0.69-2.01). Stepwise multivariate logistic regression revealed age ≥80 years and history of heart failure were associated with detection of paroxysmal atrial fibrillation whereas patients with lacunar infarction had lower odds for detection of paroxysmal atrial fibrillation. CONCLUSIONS Serial electrocardiograms had comparable detection rate of paroxysmal atrial fibrillation compared with 24-h Holter and might be a viable alternative to 24-h Holter as a first-line approach to survey for potential paroxysmal atrial fibrillation among elderly patients with acute ischemic stroke. Clinical Trial Registration: URL https://clinicaltrials.gov/ct2/show/NCT02578979Unique Identifiers: NCT02578979.",2021,"Stepwise multivariate logistic regression revealed age ≥80 years and history of heart failure were associated with detection of paroxysmal atrial fibrillation whereas patients with lacunar infarction had lower odds for detection of paroxysmal atrial fibrillation. ","['elderly patients with acute ischemic stroke', 'from October 2015 to October 2018 at six hospitals', 'acute ischemic stroke patients', 'Eligible participants were acute ischemic stroke patients with aged ≥65 years, with neither atrial fibrillation history nor any presence of atrial fibrillation on baseline electrocardiogram at admission', 'acute ischemic stroke patients without known atrial fibrillation']",['serial electrocardiograms versus 24-h Holter'],"['newly detected electrocardiogram in the serial electrocardiograms and 24-h Holter group', 'detection rates of paroxysmal atrial fibrillation', 'detection of paroxysmal atrial fibrillation', 'atrial fibrillation', 'detection rate of paroxysmal atrial fibrillation']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205309', 'cui_str': 'Known'}]","[{'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}]","[{'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]",,0.248161,"Stepwise multivariate logistic regression revealed age ≥80 years and history of heart failure were associated with detection of paroxysmal atrial fibrillation whereas patients with lacunar infarction had lower odds for detection of paroxysmal atrial fibrillation. ","[{'ForeName': 'Wen-Yi', 'Initials': 'WY', 'LastName': 'Huang', 'Affiliation': 'Department of Neurology, 56081Chang Gung University College of Medicine, Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, 56081Chang Gung University College of Medicine, Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Sheng-Feng', 'Initials': 'SF', 'LastName': 'Sung', 'Affiliation': 'Division of Neurology, Department of Internal Medicine, Ditmanson Medical Foundation, Chia-Yi Christian Hospital, Chiayi, Taiwan.'}, {'ForeName': 'Sung-Chun', 'Initials': 'SC', 'LastName': 'Tang', 'Affiliation': 'Stroke Center and Department of Neurology, 38006National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Kuo-Hsuan', 'Initials': 'KH', 'LastName': 'Chang', 'Affiliation': 'Department of Neurology, 56081Chang Gung University College of Medicine, Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Yung-Sung', 'Initials': 'YS', 'LastName': 'Huang', 'Affiliation': 'Division of Neurology, Department of Internal Medicine, Buddhist Dalin Tzu Chi General Hospital, Chiayi, Taiwan.'}, {'ForeName': 'Jiann-Der', 'Initials': 'JD', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, 56081Chang Gung University College of Medicine, Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Tsong-Hai', 'Initials': 'TH', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, 56081Chang Gung University College of Medicine, Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Jiann-Shing', 'Initials': 'JS', 'LastName': 'Jeng', 'Affiliation': 'Stroke Center and Department of Neurology, 38006National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Chang-Min', 'Initials': 'CM', 'LastName': 'Chung', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, 56081Chang Gung University College of Medicine, Chang Gung Memorial Hospital, Chiayi Branch, Chiayi, Taiwan.'}, {'ForeName': 'Yi-Ling', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': 'Institute of Population Health Sciences, 50115National Health Research Institutes, Miaoli County, Taiwan.'}, {'ForeName': 'Tsung-Ta', 'Initials': 'TT', 'LastName': 'Hsieh', 'Affiliation': 'Department of Neurology, 56081Chang Gung University College of Medicine, Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Ovbiagele', 'Affiliation': 'Department of Neurology, University of California, San Francisco, CA, USA.'}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493020938297'] 781,32640940,Impact of Goal-Directed Therapy on Delayed Ischemia After Aneurysmal Subarachnoid Hemorrhage: Randomized Controlled Trial.,"BACKGROUND AND PURPOSE Delayed cerebral ischemia (DCI) is the most important cause for a poor clinical outcome after a subarachnoid hemorrhage. The aim of this study was to assess whether goal-directed hemodynamic therapy (GDHT), as compared to standard clinical care, reduces the rate of DCI after subarachnoid hemorrhage. METHODS We conducted a prospective randomized controlled trial. Patients >18 years of age with an aneurysmal subarachnoid hemorrhage were enrolled and randomly assigned to standard therapy or GDHT. Advanced hemodynamic monitoring and predefined GDHT algorithms were applied in the GDHT group. The primary end point was the occurrence of DCI. Functional outcome was assessed using the Glasgow Outcome Scale (GOS) 3 months after discharge. RESULTS In total, 108 patients were randomized to the control (n=54) or GDHT group (n=54). The primary outcome (DCI) occurred in 13% of the GDHT group and in 32% of the control group patients (odds ratio, 0.324 [95% CI, 0.11-0.86]; P =0.021). Even after adjustment for confounding parameters, GDHT was found to be superior to standard therapy (hazard ratio, 2.84 [95% CI, 1.18-6.86]; P =0.02). The GOS was assessed 3 months after discharge in 107 patients; it showed more patients with a low disability (GOS 5, minor or no deficits) than patients with higher deficits (GOS 1-4) in the GDHT group compared with the control group (GOS 5, 66% versus 44%; GOS 1-4, 34% versus 56%; P =0.025). There was no significant difference in mortality between the groups. CONCLUSIONS GDHT reduced the rate of DCI after subarachnoid hemorrhage with a better functional outcome (GOS=5) 3 months after discharge. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01832389.",2020,"Even after adjustment for confounding parameters, GDHT was found to be superior to standard therapy (hazard ratio, 2.84 [95% CI, 1.18-6.86]; P =0.02).","['108 patients', 'After Aneurysmal Subarachnoid Hemorrhage', 'Patients >18 years of age with an aneurysmal subarachnoid hemorrhage']","['standard therapy or GDHT', 'GDHT', 'goal-directed hemodynamic therapy (GDHT', 'Goal-Directed Therapy']","['rate of DCI after subarachnoid hemorrhage', 'GOS', 'Glasgow Outcome Scale (GOS', 'occurrence of DCI', 'mortality', 'Delayed Ischemia']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751530', 'cui_str': 'Subarachnoid Hemorrhage, Aneurysmal'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1271494', 'cui_str': 'Goal directed therapy'}]","[{'cui': 'C4761225', 'cui_str': 'Delayed cerebral ischaemia'}, {'cui': 'C0038525', 'cui_str': 'Subarachnoid hemorrhage'}, {'cui': 'C0701887', 'cui_str': 'Glasgow outcome scale'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]",108.0,0.182296,"Even after adjustment for confounding parameters, GDHT was found to be superior to standard therapy (hazard ratio, 2.84 [95% CI, 1.18-6.86]; P =0.02).","[{'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Anetsberger', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Gempt', 'Affiliation': 'Department of Neurosurgery (J.G., F.R., B.M., Y.-M.R., M.W.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Blobner', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Ringel', 'Affiliation': 'Department of Neurosurgery (J.G., F.R., B.M., Y.-M.R., M.W.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Bogdanski', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heim', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Schneider', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Meyer', 'Affiliation': 'Department of Neurosurgery (J.G., F.R., B.M., Y.-M.R., M.W.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Schmid', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Yu-Mi', 'Initials': 'YM', 'LastName': 'Ryang', 'Affiliation': 'Department of Neurosurgery (J.G., F.R., B.M., Y.-M.R., M.W.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Wostrack', 'Affiliation': 'Department of Neurosurgery (J.G., F.R., B.M., Y.-M.R., M.W.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Schneider', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Ehrhardt', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Jungwirth', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}]",Stroke,['10.1161/STROKEAHA.120.029279'] 782,32647051,Effect of High-Intensity Interval Training on Glycemic Control in Adults With Type 1 Diabetes and Overweight or Obesity: A Randomized Controlled Trial With Partial Crossover.,"OBJECTIVE To study the effect of 12 weeks of high-intensity interval training (HIIT) on glycemic control in adults with type 1 diabetes and overweight or obesity. RESEARCH DESIGN AND METHODS Thirty inactive adults with type 1 diabetes who had BMI ≥25 kg/m 2 and HbA 1c ≥7.5% were randomized to 12 weeks of either HIIT exercise intervention consisting of 4 × 4-min HIIT (85-95% peak heart rate) performed thrice weekly or usual care control. In a partial crossover design, the control group subsequently performed the 12-week HIIT intervention. The primary end point was the change in HbA 1c from baseline to 12 weeks. Glycemic and cardiometabolic outcomes were measured at 0, 12, and 24 weeks. RESULTS Participants were aged 44 ± 10 years with diabetes duration 19 ± 11 years and BMI 30.1 ± 3.1 kg/m 2 . HbA 1c decreased from 8.63 ± 0.66% at baseline to 8.10 ± 1.04% at 12 weeks in the HIIT intervention group ( P = 0.01); however, this change was not significantly different from the control group (HIIT -0.53 ± 0.61%, control -0.14 ± 0.48%, P = 0.08). In participants who undertook at least 50% of the prescribed HIIT intervention, the HbA 1c reduction was significantly greater than control (HIIT -0.64 ± 0.64% [ n = 9], control -0.14 ± 0.48% [ n = 15], P = 0.04). There were no differences in insulin dose, hypoglycemia on continuous glucose monitoring, blood pressure, blood lipids, body weight, or body composition between groups. CONCLUSIONS Overall, there was no significant reduction in HbA 1c with a 12-week HIIT intervention in adults with type 1 diabetes. However, glycemic control may improve for people who undertake HIIT with greater adherence.",2020,"HbA 1c decreased from 8.63 ± 0.66% at baseline to 8.10 ± 1.04% at 12 weeks in the HIIT intervention group ( P = 0.01); however, this change was not significantly different from the control group (HIIT -0.53 ± 0.61%, control -0.14 ± 0.48%, P = 0.08).","['Adults With Type 1 Diabetes and Overweight or Obesity', 'adults with type 1 diabetes', 'Thirty inactive adults with type 1 diabetes who had BMI ≥25 kg/m 2 and HbA 1c ≥7.5', 'adults with type 1 diabetes and overweight or obesity', 'Participants were aged 44 ± 10 years with diabetes duration 19 ± 11 years and BMI 30.1 ± 3.1 kg/m 2 ']","['HIIT exercise intervention consisting of 4 × 4-min HIIT (85-95% peak heart rate) performed thrice weekly or usual care control', 'high-intensity interval training (HIIT', 'High-Intensity Interval Training']","['change in HbA 1c', 'Glycemic and cardiometabolic outcomes', 'HbA 1c reduction', 'insulin dose, hypoglycemia on continuous glucose monitoring, blood pressure, blood lipids, body weight, or body composition', 'HbA 1c']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4517683', 'cui_str': '3.1'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]",30.0,0.0504138,"HbA 1c decreased from 8.63 ± 0.66% at baseline to 8.10 ± 1.04% at 12 weeks in the HIIT intervention group ( P = 0.01); however, this change was not significantly different from the control group (HIIT -0.53 ± 0.61%, control -0.14 ± 0.48%, P = 0.08).","[{'ForeName': 'Angela S', 'Initials': 'AS', 'LastName': 'Lee', 'Affiliation': 'Department of Endocrinology, Diabetes Centre, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Johnson', 'Affiliation': 'Faculty of Health Sciences, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Margaret J', 'Initials': 'MJ', 'LastName': 'McGill', 'Affiliation': 'Department of Endocrinology, Diabetes Centre, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Overland', 'Affiliation': 'Department of Endocrinology, Diabetes Centre, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Luo', 'Affiliation': 'Department of Endocrinology, Diabetes Centre, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Callum J', 'Initials': 'CJ', 'LastName': 'Baker', 'Affiliation': 'Central Clinical School, Charles Perkins Centre, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Martinez-Huenchullan', 'Affiliation': 'Central Clinical School, Charles Perkins Centre, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jencia', 'Initials': 'J', 'LastName': 'Wong', 'Affiliation': 'Department of Endocrinology, Diabetes Centre, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Flack', 'Affiliation': 'Diabetes Centre, Bankstown-Lidcombe Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Twigg', 'Affiliation': 'Department of Endocrinology, Diabetes Centre, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia stephen.twigg@sydney.edu.au.'}]",Diabetes care,['10.2337/dc20-0342'] 783,32647053,Effects of Liraglutide on Cardiovascular Outcomes in Type 2 Diabetes Patients With and Without Baseline Metformin Use: Post Hoc Analyses of the LEADER Trial.,,2020,,['Type 2 Diabetes Patients With and'],['Liraglutide'],['Cardiovascular Outcomes'],"[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0347564,,"[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Crowley', 'Affiliation': 'Division of Endocrinology, Metabolism, and Nutrition, Department of Medicine, Duke University School of Medicine, Durham, NC matthew.crowley@duke.edu.'}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Anastasia-Stefania', 'Initials': 'AS', 'LastName': 'Alexopoulos', 'Affiliation': 'Division of Endocrinology, Metabolism, and Nutrition, Department of Medicine, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Thomas Jon', 'Initials': 'TJ', 'LastName': 'Jensen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Rasmussen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Hans A', 'Initials': 'HA', 'LastName': 'Saevereid', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery, St. Michael's Hospital and University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC.'}]",Diabetes care,['10.2337/dc20-0437'] 784,32641079,Association between recipient survival and blood donor age after blood transfusion in a surgery intensive care unit: a multicenter randomized controlled trial study protocol.,"BACKGROUND Blood from younger individuals has been shown to improve physiological function in recipients in laboratory research, and many proteins from human peripheral blood show antisenescence capabilities. Thus, researchers have questioned whether blood from young donors is superior to blood from older donors. Blood transfusion is a key supportive therapy for trauma patients, and recent studies have reported the influence of blood donor age on recipient patient prognosis. Although some retrospective results found that blood from young donors improves survival, no influence of blood donor age was observed on outcomes in other study groups. The reasons for this discrepancy are complicated, but the fact that data were not obtained from randomized controlled trial (RCT) data should be considered. The current protocol and analysis method provide a feasible RCT design to evaluate the prognosis of severely ill surgery patients who were transfused with blood products from blood donors of different ages. METHODS The current study is a pragmatic multicenter RCT (open, parallel-group, non-masked, superiority trial). Recruited surgery intensive care unit patients will be randomized into three groups and transfused with blood products from male donors of different ages (< 25, 25-45, and > 45 years). Survival time will be measured within 28 days. The survival characteristics, possible interaction between variables, and potential factors associated with death will be analyzed by Kaplan-Meier analysis, two-way ANOVA, and Cox proportional hazards model, respectively. TRIAL REGISTRATION ChiCTR: ChiCTR190002. Registered on 22 March 2019. http://www.chictr.org.cn/showproj.aspx?proj=36867 .",2020,"Although some retrospective results found that blood from young donors improves survival, no influence of blood donor age was observed on outcomes in other study groups.","['trauma patients', 'from male donors of different ages (<\u200925, 25-45, and\u2009>\u200945\u2009years', 'Recruited surgery intensive care unit patients', 'severely ill surgery patients who were transfused with blood products from blood donors of different ages']",['transfused with blood products'],"['Survival time', 'survival']","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0456388', 'cui_str': 'Blood product'}, {'cui': 'C0005795', 'cui_str': 'Blood donor'}]","[{'cui': 'C0456388', 'cui_str': 'Blood product'}]","[{'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.182186,"Although some retrospective results found that blood from young donors improves survival, no influence of blood donor age was observed on outcomes in other study groups.","[{'ForeName': 'Xianfei', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': ""School of Medicine, Northwest University, Xi'an, 710069, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liao', 'Affiliation': 'Department of Transfusion Medicine, Third Affiliated Hospital of Guangxi Medical University, Nanning, 530031, China.'}, {'ForeName': 'Xiaoshuang', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""Department of Transfusion Medicine, Xijing Hospital, The Fourth Military Medical University, Xi'an, 710032, China.""}, {'ForeName': 'Jinmei', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Department of Transfusion Medicine, Xijing Hospital, The Fourth Military Medical University, Xi'an, 710032, China.""}, {'ForeName': 'Chenxing', 'Initials': 'C', 'LastName': 'Da', 'Affiliation': ""Department of Endocrinology, Shaanxi Corps Hospital, Chinese People's Armed Police Forces, Xi'an, 710054, China.""}, {'ForeName': 'Zhijun', 'Initials': 'Z', 'LastName': 'Tan', 'Affiliation': ""Department of Statistics, Fourth Military Medical University, Xi'an, 710032, China.""}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Feng', 'Affiliation': ""Department of Digestive Surgery, Xijing Hospital, Xi'an, 710032, China.""}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Yin', 'Affiliation': ""Department of Transfusion Medicine, Xijing Hospital, The Fourth Military Medical University, Xi'an, 710032, China.""}, {'ForeName': 'Dongjian', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Transfusion Medicine, 908th Hospital of PLA, Yingtan, 335000, China. dearwdj@163.com.'}, {'ForeName': 'Xingbin', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': ""Department of Transfusion Medicine, Xijing Hospital, The Fourth Military Medical University, Xi'an, 710032, China. hxbyqh@163.com.""}]",Trials,['10.1186/s13063-020-04452-6'] 785,32641081,Effect of preoperative immunonutrition on outcomes of colon cancer surgery: study protocol for a randomized controlled trial.,"BACKGROUND Current guidelines recommend the prescription of immune-enriched oral nutritional supplements for malnourished patients before major gastrointestinal surgery. However, the benefit of preoperative immunonutrition is still controversial. This randomized controlled trial aims to evaluate the effect of preoperative immunonutrition on the outcomes of surgery for colon cancer. METHODS/DESIGN Patients with primary colon cancer will be included as study participants after screening. They will be randomly assigned (in a ratio of 1:1) to receive preoperative immunonutrition added to the normal diet (experimental arm) or consume normal diet alone (control arm). Patients in the experimental arm will receive oral supplementation (400 mL/day) with arginine and ω-3 fatty acids for 7 days before elective surgery. The primary endpoint is the rate of infectious complications, while the secondary endpoints are postoperative complication rate, change in body weight, length of hospital stay, and nature of fecal microbiome. The authors hypothesize that the rate of infectious complications would be 13% in the experimental arm and 30% in the control arm. With a two-sided alpha of 0.05 and a power of 0.8, the sample size is calculated as 176 patients (88 per arm). DISCUSSION Although there have been many studies demonstrating significant benefits of preoperative immunonutrition, these were limited by a small sample size and potential publication bias. Despite the recommendation of immunonutrition before surgery in nutritional guidelines, its role in reduction of rate of infectious complications is still controversial. This trial is expected to provide evidence for the benefits of administration of preoperative immunonutrition in patients with colon cancer. TRIAL REGISTRATION Clinical Research Information Service KCT0003770 . Registered on 15 April 2019.",2020,"The primary endpoint is the rate of infectious complications, while the secondary endpoints are postoperative complication rate, change in body weight, length of hospital stay, and nature of fecal microbiome.","['colon cancer surgery', 'Patients with primary colon cancer will be included as study participants after screening', '176 patients (88 per arm', 'malnourished patients before major gastrointestinal surgery', 'patients with colon cancer']","['oral supplementation', 'arginine and ω-3 fatty acids', 'preoperative immunonutrition added to the normal diet (experimental arm) or consume normal diet alone (control arm', 'preoperative immunonutrition']","['postoperative complication rate, change in body weight, length of hospital stay, and nature of fecal microbiome', 'rate of infectious complications']","[{'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0524722', 'cui_str': 'Gastrointestinal surgery'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.261072,"The primary endpoint is the rate of infectious complications, while the secondary endpoints are postoperative complication rate, change in body weight, length of hospital stay, and nature of fecal microbiome.","[{'ForeName': 'Soo Young', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Chonnam National University Hwasun Hospital and Medical School, 322 Seoyang-ro Hwasun-eup, Hwasun-gun, Jeonnam, 58128, South Korea.'}, {'ForeName': 'Seung-Seop', 'Initials': 'SS', 'LastName': 'Yeom', 'Affiliation': 'Department of Surgery, Chonnam National University Hwasun Hospital and Medical School, 322 Seoyang-ro Hwasun-eup, Hwasun-gun, Jeonnam, 58128, South Korea.'}, {'ForeName': 'Chang Hyun', 'Initials': 'CH', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Chonnam National University Hwasun Hospital and Medical School, 322 Seoyang-ro Hwasun-eup, Hwasun-gun, Jeonnam, 58128, South Korea.'}, {'ForeName': 'Hyeong Rok', 'Initials': 'HR', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Chonnam National University Hwasun Hospital and Medical School, 322 Seoyang-ro Hwasun-eup, Hwasun-gun, Jeonnam, 58128, South Korea. drkhr@jnu.ac.kr.'}]",Trials,['10.1186/s13063-020-04544-3'] 786,32641090,Impacts of chest compression cycle length and real-time feedback with a CPRmeter® on chest compression quality in out-of-hospital cardiac arrest: study protocol for a multicenter randomized controlled factorial plan trial.,"BACKGROUND With a survival rate of 6 to 11%, out-of-hospital cardiac arrest (OHCA) remains a healthcare challenge with room for improvement in morbidity and mortality. The guidelines emphasize the highest possible quality of cardiopulmonary resuscitation (CPR) and chest compressions (CC). It is essential to minimize CC interruptions, and therefore increase the chest compression fraction (CCF), as this is an independent factor for survival. Survival is significantly and positively correlated with the suitability of CCF targets, CC frequency, CC depth, and brief predefibrillation pause. CC guidance improves adherence to recommendations and allows closer alignment with the CC objectives. The possibility of improving CCF by lengthening the time between two CC relays and the effect of real-time feedback on the quality of the CC must be investigated. METHODS Using a 2 × 2 factorial design in a multicenter randomized trial, two hypotheses will be tested simultaneously: (i) a 4-min relay rhythm improves the CCF (reducing the no-flow time) compared to the currently recommended 2-min relay rate, and (ii) a guiding tool improves the quality of CC. Primary outcomes (i) CCF and (ii) correct compression score will be recorded by a real-time feedback device. Five hundred adult nontraumatic OHCAs will be included over 2 years. Patients will be randomized in a 1:1:1:1 distribution receiving advanced CPR as follows: 2-min blind, 2 min with guidance, 4-min blind, or 4 min with guidance. Secondary outcomes are the depth, frequency, and release of CC; length (care, no-flow, and low-flow); rate of return of spontaneous circulation; characteristics of advanced CPR; survival at hospital admission; survival and neurological state on days 1 and 30 (or intensive care discharge); and dosage of neuron-specific enolase on days 1 and 3. DISCUSSION This study will contribute to assessing the impact of real-time feedback on CC quality in practical conditions of OHCA resuscitation. It will also provide insight into the feasibility of extending the relay rhythm between two rescuers from the currently recommended 2 to 4 min. TRIAL REGISTRATION ClinicalTrials.gov, NCT03817892 . Registered on 28 January 2019.",2020,"Survival is significantly and positively correlated with the suitability of CCF targets, CC frequency, CC depth, and brief predefibrillation pause.","['Five hundred adult nontraumatic OHCAs', 'out-of-hospital cardiac arrest']","['chest compression cycle length and real-time feedback with a CPRmeter®', 'CC guidance']","['chest compression quality', 'suitability of CCF targets, CC frequency, CC depth, and brief predefibrillation pause', 'Survival', 'Primary outcomes (i) CCF and (ii) correct compression score will be recorded by a real-time feedback device', 'depth, frequency, and release of CC; length (care, no-flow, and low-flow); rate of return of spontaneous circulation; characteristics of advanced CPR; survival at hospital admission; survival and neurological state on days 1 and 30 (or intensive care discharge); and dosage of neuron-specific enolase on days 1 and 3', 'survival rate']","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}]","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0202144', 'cui_str': 'Neuron-specific enolase measurement'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",2.0,0.0745678,"Survival is significantly and positively correlated with the suitability of CCF targets, CC frequency, CC depth, and brief predefibrillation pause.","[{'ForeName': 'Clément', 'Initials': 'C', 'LastName': 'Buléon', 'Affiliation': 'UNICAEN, CHU de Caen Normandie, Pôle Réanimations-Anesthésie-SAMU, Normandie University, 14000, Caen, France. buleon-c@chu-caen.fr.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Parienti', 'Affiliation': 'UNICAEN, CHU de Caen Normandie, Unité de Biostatistiques et de Recherche Clinique, Normandie University, 14000, Caen, France.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Morilland-Lecoq', 'Affiliation': 'UNICAEN, CHU de Caen Normandie, Unité de Biostatistiques et de Recherche Clinique, Normandie University, 14000, Caen, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Halbout', 'Affiliation': 'UNICAEN, CHU de Caen Normandie, Pôle Réanimations-Anesthésie-SAMU, Normandie University, 14000, Caen, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Cesaréo', 'Affiliation': 'Department of Emergency Medicine, SAMU 69, Hospital Edouard Herriot, University Hospital of Lyon, Lyon, France.'}, {'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Dubien', 'Affiliation': 'Department of Emergency Medicine, SAMU 69, Hospital Edouard Herriot, University Hospital of Lyon, Lyon, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Jardel', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, SAMU 76, Rouen University Hospital, Rouen Cedex, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Boyer', 'Affiliation': 'SAMU Amiens, CHU Amiens-Picardie, Amiens, France.'}, {'ForeName': 'Kévin', 'Initials': 'K', 'LastName': 'Husson', 'Affiliation': 'Emergency Medicine Department and SAMU 59, Lille University Hospital, Lille, France.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Andriamirado', 'Affiliation': ""Emergency Department, Centre Hospitalier d'Evreux, Evreux, France.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Benet', 'Affiliation': 'Emergency Department, Centre Hospitalier du Havre, Le Havre, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Morel-Marechal', 'Affiliation': ""Emergency Department, Centre Hospitalier d'Elbeuf Louviers Val-de-Reuil, Elbeuf, France.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Aubrion', 'Affiliation': 'UNICAEN, CHU de Caen Normandie, Pôle Réanimations-Anesthésie-SAMU, Normandie University, 14000, Caen, France.'}, {'ForeName': 'Catalin', 'Initials': 'C', 'LastName': 'Muntean', 'Affiliation': 'Emergency Department, Centre Hospitalier de Cherbourg, Cherbourg, France.'}, {'ForeName': 'Erwan', 'Initials': 'E', 'LastName': 'Dupire', 'Affiliation': 'Emergency Department, Centre Hospitalier de Valenciennes, Valenciennes, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Roupie', 'Affiliation': 'UNICAEN, CHU de Caen Normandie, Pôle Réanimations-Anesthésie-SAMU, Normandie University, 14000, Caen, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Hubert', 'Affiliation': 'University Lille, EA 2694 - Santé Publique: Épidémiologie et Qualité des Soins, F-59000, Lille, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Vilhelm', 'Affiliation': 'University Lille, EA 2694 - Santé Publique: Épidémiologie et Qualité des Soins, F-59000, Lille, France.'}, {'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Gueugniaud', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, SAMU 76, Rouen University Hospital, Rouen Cedex, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04536-3'] 787,32641094,"Evaluating interventions to improve test, treat, and track (T3) malaria strategy among over-the-counter medicine sellers (OTCMS) in some rural communities of Fanteakwa North district, Ghana: study protocol for a cluster randomized controlled trial.","BACKGROUND The World Health Organization initiated test, treat, and track (T3) malaria strategy to support malaria-endemic countries in their efforts to achieve universal coverage with diagnostic testing, antimalarial treatment, and strengthening surveillance systems. Unfortunately, T3 is not adopted by over-the-counter medicine sellers (OTCMS) where many patients with malaria-like symptoms first seek treatment. Sub-Saharan African countries are considering introducing and scaling up RDTs in these outlets to reduce malaria burden. In this context, this study is aimed at improving implementation of the T3 among OTCMS using a number of intervention tools that could be scaled-up easily at the national level. METHODS/DESIGN The interventions will be evaluated using a two-arm, cluster randomized trial across 8 rural communities (4 clusters per arm), in two adjacent districts (Fanteakwa North and Fanteakwa South districts) of Ghana. A total of 8 OTCMS in the intervention arm and 5 OTCMS in the control arm in the selected communities will participate in the study. In the intervention arm only, subsidized malaria rapid diagnostic test (mRDT) kits will be introduced after the OTCMS have been trained on how to use the kit appropriately. Supervision, technical assistance, feedbacks, and collection of data will be provided on a regular basis at the participating medicine stores. The primary outcome is the proportion of children under 10 years with fever or suspected to have malaria visiting OTCMS and tested (using mRDT) before treatment. Secondary outcomes will include adherence to national malaria treatment guidelines and recommended mRDT retail price. Outcomes will be measured using mainly a household survey supplemented by mystery client survey and a surveillance register on malaria tests conducted by the OTCMS during patient consultations. Data collected will be double entered and verified using Microsoft Access 2010 (Microsoft Inc., Redmond, Washington) and analyzed using STATA version 11.0. DISCUSSION The trial will provide evidence on the combined effectiveness of provider and community interventions in improving adherence to the T3 initiative among OTCMS in rural Ghana. ETHICAL CLEARANCE NMIMR-IRB CPN 086/18-19 TRIAL REGISTRATION: ISRCTN registry ISRCTN77836926 . Registered on 4 November 2019.",2020,"In the intervention arm only, subsidized malaria rapid diagnostic test (mRDT) kits will be introduced after the OTCMS have been trained on how to use the kit appropriately.","['some rural communities of Fanteakwa North district, Ghana', '8 rural communities (4 clusters per arm), in two adjacent districts (Fanteakwa North and Fanteakwa South districts) of Ghana']","['track (T3) malaria strategy among over-the-counter medicine sellers (OTCMS', 'provider and community interventions', 'subsidized malaria rapid diagnostic test (mRDT) kits', 'OTCMS']","['adherence to national malaria treatment guidelines and recommended mRDT retail price', 'proportion of children under 10\u2009years with fever or suspected to have malaria visiting OTCMS and tested (using mRDT']","[{'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0017516', 'cui_str': 'Ghana'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}]","[{'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0013231', 'cui_str': 'Drugs, Non-Prescription'}, {'cui': 'C0042462', 'cui_str': 'Vendors'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0430022', 'cui_str': 'Diagnostic procedure'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0430022', 'cui_str': 'Diagnostic procedure'}, {'cui': 'C0080045', 'cui_str': 'Prices'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0013231', 'cui_str': 'Drugs, Non-Prescription'}, {'cui': 'C0042462', 'cui_str': 'Vendors'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",8.0,0.164506,"In the intervention arm only, subsidized malaria rapid diagnostic test (mRDT) kits will be introduced after the OTCMS have been trained on how to use the kit appropriately.","[{'ForeName': 'Olajoju Temidayo', 'Initials': 'OT', 'LastName': 'Soniran', 'Affiliation': 'Noguchi Memorial Institute for Medical Research, College of Health Sciences, University of Ghana, Legon, Accra, Ghana.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Abuaku', 'Affiliation': 'Noguchi Memorial Institute for Medical Research, College of Health Sciences, University of Ghana, Legon, Accra, Ghana. babuaku@noguchi.ug.edu.gh.'}, {'ForeName': 'Collins Stephen', 'Initials': 'CS', 'LastName': 'Ahorlu', 'Affiliation': 'Noguchi Memorial Institute for Medical Research, College of Health Sciences, University of Ghana, Legon, Accra, Ghana.'}]",Trials,['10.1186/s13063-020-04509-6'] 788,32641096,Protocol for a randomized controlled trial to assess two procedures of vaginal native tissue repair for pelvic organ prolapse at the time of the questioning on vaginal prosthesis: the TAPP trial.,"BACKGROUND Native tissue cystocele repair has been the cornerstone of prolapse surgery, especially since the learned societies warned clinicians and patients about serious mesh-related complications. Surgical techniques mainly consist in anterior colporraphy and vaginal patch plastron. However, success rates of native tissue cystocele repair are heterogeneous, depending on the design of studies and definition of outcomes. To date, high-quality data comparing vaginal native tissue procedures are still lacking. METHODS Herein we aimed to describe the design of the first randomized controlled trial (TAPP) comparing anterior colporraphy (plication of the muscularis and adventitial layers of the vaginal wall) and vaginal patch plastron (bladder support anchored on the tendinous arch of the pelvic fascia by lateral sutures) techniques. Our aim is to assess the effectiveness of vaginal native tissue repair at 1 year for cystocele with a combined definition of success-anatomic and functional. The primary endpoint will be the success rate 1 year after surgery with a composite of objective and subjective measures (Aa and Ba points < 0 from POP-Q (Pelvic Organ Prolapse Quantification System) and a negative answer to question 3 of Pelvic Floor Distress Inventory and no need for additional treatment). DISCUSSION A prospective study has found a success rate at 35% for anterior colporraphy based on a combined definition, both anatomic and functional, as recently recommended. However, the definition of anatomic was strict (POP-Q< 2), while it seems that the best definition of anatomic success is ""no prolapse among the hymen"", that is to say Aa and Ba points from the POP-Q classification < 0. We hypothesize that vaginal patch plastron will have a better anatomic and functional success comparatively to anterior colporraphy because native tissue is added, as it corrects both median and lateral cystoceles thanks to bilateral paravaginal suspension. TRIAL REGISTRATION CHU LIMOGES is the sponsor of this research (n°87RI18_0013). This research is supported by the French Department of Health (PHRC 2018-A03476-49) and will be conducted with the support of DGOS (PHRC interregional - GIRCI SOHO). The study protocol was approved by the Human Subjects Protection Review Board (Comité de Protection des Personnes) on May 16, 2019. The trial is registered in the ClinicalTrials.gov registry ( NCT03875989 ).",2020,Our aim is to assess the effectiveness of vaginal native tissue repair at 1 year for cystocele with a combined definition of success-anatomic and functional.,"['Human Subjects Protection Review Board (Comité de Protection des Personnes) on May 16, 2019']","['anterior colporraphy (plication of the muscularis and adventitial layers of the vaginal wall) and vaginal patch plastron (bladder support', 'vaginal native tissue repair']",['success rate 1\u2009year after surgery with a composite of objective and subjective measures (Aa and Ba points\u2009<\u20090 from POP-Q (Pelvic Organ Prolapse Quantification System) and a negative answer to question 3 of Pelvic Floor Distress Inventory and no need for additional treatment'],"[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0011702', 'cui_str': '4-(4-Amino-4-Carboxybutyl)-1-(5-Amino-5-Carboxypentyl)-3,5-bis(3-Amino-3-Carboxypropyl)pyridinium'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0225358', 'cui_str': 'Muscularis propria'}, {'cui': 'C0447612', 'cui_str': 'Vaginal wall'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.141485,Our aim is to assess the effectiveness of vaginal native tissue repair at 1 year for cystocele with a combined definition of success-anatomic and functional.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lacorre', 'Affiliation': 'Department of Gynecology and Obstetrics, CHU Limoges, 8 avenue Dominique Larrey, 87042, Limoges Cedex, France. aymlacorre@hotmail.fr.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Vidal', 'Affiliation': 'Pôle Femme Mère Couple, Hôpital Paule de Viguier, CHU Purpan, 330 avenue de Grande Bretagne, 31059, Toulouse, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Campagne-Loiseau', 'Affiliation': 'Department of Gynecology and Obstetrics, CHU Clermont-Ferrand Estaing, 1 place Lucie Aubrac, 63100, Clermont-Ferrand, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Marin', 'Affiliation': 'Institute of Neurological Epidemiology and Tropical Neurology, Faculté de Médecine de Limoges, 2 rue du Docteur Marcland, 87025, Limoges, France.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Aubard', 'Affiliation': 'Department of Gynecology and Obstetrics, CHU Limoges, 8 avenue Dominique Larrey, 87042, Limoges Cedex, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Siegerth', 'Affiliation': 'Department of Gynecology and Obstetrics, Hôpital de Tulle, 3 place Maschat, 19000, Tulle, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mesnard', 'Affiliation': 'Department of Gynecology and Obstetrics, Hôpital de Brive-La-Gaillarde, 3 boulevard Dr Verlhac, 19100, Brive-La-Gaillarde, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Chantalat', 'Affiliation': 'Department of Gynecology and Obstetrics, CHU Toulouse Rangueil, 1 avenue du Professeur Jean Poulhès, 31400, Toulouse, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hocke', 'Affiliation': ""Department of Gynecology and Obstetrics, CHU Bordeaux Pellegrin, Centre Aliénor d'Aquitaine, Place Amélie Raba Léon, 33076, Bordeaux, France.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Gauthier', 'Affiliation': 'Department of Gynecology and Obstetrics, CHU Limoges, 8 avenue Dominique Larrey, 87042, Limoges Cedex, France.'}]",Trials,['10.1186/s13063-020-04512-x'] 789,32641097,The implementation and utility of patient screening logs in a multicentre randomised controlled oncology trial.,"BACKGROUND The utility of patient screening logs and their impact on improving trial recruitment rates are unclear. We conducted a retrospective exploratory analysis of screening data collected within a multicentre randomised controlled trial investigating chemotherapy for upper tract urothelial carcinoma. METHODS Participating centres maintained a record of patients meeting basic screening criteria stipulated in the trial protocol, submitting logs regularly to the clinical trial coordinating centre (CTC). Sites recorded the number of patients ineligible, not approached, declined and randomised. The CTC monitored proportions of eligible patients, approach rate (proportion of eligible patients approached) and acceptance rate (proportion recruited of those approached). Data were retrospectively analysed to identify patterns of screening activity and correlation with recruitment. RESULTS Data were collected between May 2012 and August 2016, during which time 71 sites were activated-a recruitment period of 2768 centre months. A total of 1138 patients were reported on screening logs, with 2300 requests for logs sent by the CTC and 47% of expected logs received. A total of 758 patients were reported as ineligible, 36 eligible patients were not approached and 207 declined trial participation. The approach rate was 91% (344/380), and the acceptance rate was 40% (137/344); these rates remained consistent throughout the data collection. The main reason patients provided for declining (99/207, 48%) was not wanting to receive chemotherapy. There was a moderately strong correlation (r = 0.47) between the number reported on screening logs and the number recruited per site. Considerable variation in data between centres was observed, and 54/191 trial participants (28%) enrolled during this period were not reported on logs. CONCLUSIONS Central collection of screening logs can identify reasons for patients declining trial participation and help monitor trial activity at sites; however, obtaining complete data can be challenging. There was a correlation between the number of patients reported on logs and recruitment; however, this was likely confounded by sites' available patient population. The use of screening logs may not be appropriate for all trials, and their use should be carefully considered in relation to the associated workload. No evidence was found that central collection of screening logs improved recruitment rates in this study, and their continued use warrants further investigation. TRIAL REGISTRATION ISRCTN98387754 . Registered on 31 January 2012.",2020,"No evidence was found that central collection of screening logs improved recruitment rates in this study, and their continued use warrants further investigation. ","['A total of 758 patients were reported as ineligible, 36 eligible patients were not approached and 207 declined trial participation', 'A total of 1138 patients were reported on screening logs, with 2300 requests for logs sent by the CTC and 47% of expected logs received', '54/191 trial participants (28%) enrolled during this period were not reported on logs', 'upper tract urothelial carcinoma', 'Participating centres maintained a record of patients meeting basic screening criteria stipulated in the trial protocol, submitting logs regularly to the clinical trial coordinating centre (CTC']",['chemotherapy'],"['approach rate', 'acceptance rate']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0686900', 'cui_str': 'Request for'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C2355580', 'cui_str': 'Record of'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}]",1138.0,0.424434,"No evidence was found that central collection of screening logs improved recruitment rates in this study, and their continued use warrants further investigation. ","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lewis', 'Affiliation': 'Clinical Trials and Statistics Unit at the Institute of Cancer Research (ICR-CTSU), London, SM2 5NG, UK. Rebecca.Lewis@icr.ac.uk.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Todd', 'Affiliation': 'Clinical Trials and Statistics Unit at the Institute of Cancer Research (ICR-CTSU), London, SM2 5NG, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Newton', 'Affiliation': 'Clinical Trials and Statistics Unit at the Institute of Cancer Research (ICR-CTSU), London, SM2 5NG, UK.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Jones', 'Affiliation': 'Institute of Cancer Sciences, Beatson West of Scotland Cancer Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Wilson', 'Affiliation': 'Population Health Sciences, Bristol Medical School, Bristol, UK.'}, {'ForeName': 'Jenny L', 'Initials': 'JL', 'LastName': 'Donovan', 'Affiliation': 'Population Health Sciences, Bristol Medical School, Bristol, UK.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Bryan', 'Affiliation': 'Institute of Cancer & Genomic Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Birtle', 'Affiliation': 'Royal Preston Hospital, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'Clinical Trials and Statistics Unit at the Institute of Cancer Research (ICR-CTSU), London, SM2 5NG, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04559-w'] 790,32641101,"Generate-Boost: study protocol for a prospective, multicenter, randomized controlled, double-blinded phase II trial to evaluate efficacy and safety of bortezomib in patients with severe autoimmune encephalitis.","BACKGROUND Autoimmune encephalitis is a new spectrum of autoimmune disorders of the central nervous system (CNS), which are characterized by pathogenic autoantibodies against neuronal surface antigens. Clinical presentations range from acute to subacute encephalopathy with neurological and psychiatric symptoms, and life-threatening autonomic dysfunction in severe cases. There exist no approved therapies nor is data available from controlled clinical trials. Patients are usually treated with diverse combinations of immunotherapy. However, effect of immunotherapy on antibody-producing cells and thus on levels of pathogenic autoantibodies is insufficient. Therefore, therapeutic response is sometimes prolonged with necessity of long-time intensive care treatment and also irreversible deficits occur in severe cases. This trial will investigate the efficacy and safety of bortezomib, a proteasome inhibitor known to selectively deplete plasma cells, in patients with severe autoimmune encephalitis who have been treated with rituximab with insufficient response. METHODS Generate-Boost is an investigator-initiated, multicenter, double-blinded, randomized controlled phase II trial which will be conducted in specialized neurological hospitals within the GENERATE (GErman NEtwork for Research on AuToimmune Encephalitis) network in Germany. Adult patients with severe autoimmune encephalitis (modified Rankin scale, mRS ≥ 3), autoantibodies against neuronal surface antigens, and pretreatment with rituximab are eligible for study participation. Fifty patients will be randomized 1:1 and undergo up to 3 cycles (each 21 days with 4 s. c. applications) of bortezomib or placebo. All patients will receive concomitant medication with dexamethasone, acyclovir and co-trimoxazole. The primary efficacy endpoint is the mRS score 17 weeks after first treatment application. Secondary endpoints are neurocognitive function, antibody titers, markers of neuronal cell damage, length of ICU/hospital stay, and mRS and Glasgow coma scale scores throughout the trial up to week 17. General and bortezomib-specific adverse events are monitored continuously. DISCUSSION The expected outcome of the study is to obtain first reliable data on a hypothesis-driven therapeutic option in severe and difficult-to-treat autoimmune encephalitis. If treatment with bortezomib is beneficial in these cases, this will be the basis for implementation in the current guidelines. TRIAL REGISTRATION Clinicaltrials.gov , NCT03993262 . Registered June 20, 2019; German Clinical Trials Register, DRKS00017497.",2020,"Adult patients with severe autoimmune encephalitis (modified Rankin scale, mRS ≥ 3)","['specialized neurological hospitals within the GENERATE (GErman NEtwork for Research on AuToimmune Encephalitis) network in Germany', 'Fifty patients', 'patients with severe autoimmune encephalitis who have been treated with rituximab with insufficient response', 'Adult patients with severe autoimmune encephalitis (modified Rankin scale, mRS\u2009≥\u20093', 'patients with severe autoimmune encephalitis']","['dexamethasone, acyclovir and co-trimoxazole', 'bortezomib', 'bortezomib or placebo', 'immunotherapy']","['neurocognitive function, antibody titers, markers of neuronal cell damage, length of ICU/hospital stay, and mRS and Glasgow coma scale scores', 'efficacy and safety', 'mRS score']","[{'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0393639', 'cui_str': 'Autoimmune encephalitis'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0001367', 'cui_str': 'Acyclovir'}, {'cui': 'C0041044', 'cui_str': 'sulfamethoxazole and trimethoprim'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",50.0,0.263428,"Adult patients with severe autoimmune encephalitis (modified Rankin scale, mRS ≥ 3)","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Wickel', 'Affiliation': 'Section of Translational Neuroimmunology, Hans Berger Department of Neurology, Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany.'}, {'ForeName': 'Ha-Yeun', 'Initials': 'HY', 'LastName': 'Chung', 'Affiliation': 'Section of Translational Neuroimmunology, Hans Berger Department of Neurology, Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Platzer', 'Affiliation': 'Center of Clinical Studies, Jena University Hospital, Jena, 07747, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lehmann', 'Affiliation': 'Center of Clinical Studies, Jena University Hospital, Jena, 07747, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Prüss', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE) Berlin and Department of Neurology and Experimental Neurology, Charité - Universitätsmedizin Berlin, 10117, Berlin, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Leypoldt', 'Affiliation': 'Neuroimmunology, Institute of Clinical chemistry and Department of Neurology, University Hospital Schleswig-Holstein and Christian-Albrechts-University, Kiel, 24105, Kiel, Germany.'}, {'ForeName': 'Albrecht', 'Initials': 'A', 'LastName': 'Günther', 'Affiliation': 'Section of Translational Neuroimmunology, Hans Berger Department of Neurology, Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Scherag', 'Affiliation': 'Center of Clinical Studies, Jena University Hospital, Jena, 07747, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Geis', 'Affiliation': 'Section of Translational Neuroimmunology, Hans Berger Department of Neurology, Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany. Christian.Geis@med.uni-jena.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04516-7'] 791,32646746,Physiological factors determining downhill vs uphill running endurance performance.,"OBJECTIVES Recent studies investigated the determinants of trail running performance (i.e., combining uphill (UR) and downhill running sections (DR)), while the possible specific physiological factors specifically determining UR vs DR performances (i.e., isolating UR and DR) remain presently unknown. This study aims to determine the cardiorespiratory responses to outdoor DR vs UR time-trial and explore the determinants of DR and UR performance in highly trained runners. DESIGN Randomized controlled trial. METHODS Ten male highly-trained endurance athletes completed 5-km DR and UR time-trials (average grade: ±8%) and were tested for maximal oxygen uptake, lower limb extensor maximal strength, local muscle endurance, leg musculotendinous stiffness, vertical jump ability, explosivity/agility and sprint velocity. Predictors of DR and UR performance were investigated using correlation and commonality regression analyses. RESULTS Running velocity was higher in DR vs UR time-trial (20.4±1.0 vs 12.0±0.5km·h -1 , p<0.05) with similar average heart rate (95±2% vs 94±2% maximal heart rate; p>0.05) despite lower average V̇O 2 (85±8% vs 89±7% V̇O 2max ; p<0.05). Velocity at V̇O 2max (vV̇O 2max ) body mass index (BMI) and maximal extensor strength were significant predictors of UR performance (r 2 =0.94) whereas vV̇O 2max , leg musculotendinous stiffness and maximal extensor strength were significant predictors of DR performance (r 2 =0.84). CONCLUSIONS Five-km UR and DR running performances are both well explained by three independent predictors. If two predictors are shared between UR and DR performances (vV̇O 2max and maximal strength), their relative contribution is different and, importantly, the third predictor appears very specific to the exercise modality (BMI for UR vs leg musculotendinous stiffness for DR).",2021,"(vV̇O 2max ) body mass index (BMI) and maximal extensor strength were significant predictors of UR performance (r 2 =0.94) whereas vV̇O 2max , leg musculotendinous stiffness and maximal extensor strength were significant predictors of DR performance (r 2 =0.84). ","['Ten male highly-trained endurance athletes completed 5-km DR and UR time-trials (average grade: ±8%) and were tested for', 'highly trained runners']",['combining uphill (UR) and downhill running sections (DR'],"['UR and DR running performances', 'Running velocity', 'vV̇O 2max ) body mass index (BMI) and maximal extensor strength', 'vV̇O 2max , leg musculotendinous stiffness and maximal extensor strength', 'UR and DR performances (vV̇O 2max and maximal strength', 'Velocity at V̇O 2max', 'average heart rate', 'UR performance', 'DR and UR performance', 'maximal oxygen uptake, lower limb extensor maximal strength, local muscle endurance, leg musculotendinous stiffness, vertical jump ability, explosivity/agility and sprint velocity']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0035953', 'cui_str': 'Running'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",10.0,0.0353636,"(vV̇O 2max ) body mass index (BMI) and maximal extensor strength were significant predictors of UR performance (r 2 =0.94) whereas vV̇O 2max , leg musculotendinous stiffness and maximal extensor strength were significant predictors of DR performance (r 2 =0.84). ","[{'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Lemire', 'Affiliation': 'University of Strasbourg, Faculty of Medicine, Translational Medicine Federation (FMTS), UR 3072, France; University of Strasbourg, Faculty of Sport Sciences, France. Electronic address: marcel.lemire@unistra.fr.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Hureau', 'Affiliation': 'University of Strasbourg, Faculty of Medicine, Translational Medicine Federation (FMTS), UR 3072, France; University of Strasbourg, Faculty of Sport Sciences, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Favret', 'Affiliation': 'University of Strasbourg, Faculty of Medicine, Translational Medicine Federation (FMTS), UR 3072, France; University of Strasbourg, Faculty of Sport Sciences, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Geny', 'Affiliation': 'University of Strasbourg, Faculty of Medicine, Translational Medicine Federation (FMTS), UR 3072, France; University Hospitals of Strasbourg, Physiology and Functional Explorations Department, Civil Hospital, France.'}, {'ForeName': 'Blah Y L', 'Initials': 'BYL', 'LastName': 'Kouassi', 'Affiliation': 'University of Strasbourg, Faculty of Medicine, Translational Medicine Federation (FMTS), UR 3072, France; University of Strasbourg, Faculty of Sport Sciences, France.'}, {'ForeName': 'Mourad', 'Initials': 'M', 'LastName': 'Boukhari', 'Affiliation': 'University of Strasbourg, Faculty of Sport Sciences, France.'}, {'ForeName': 'Evelyne', 'Initials': 'E', 'LastName': 'Lonsdorfer', 'Affiliation': 'University of Strasbourg, Faculty of Medicine, Translational Medicine Federation (FMTS), UR 3072, France; University Hospitals of Strasbourg, Physiology and Functional Explorations Department, Civil Hospital, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Remetter', 'Affiliation': 'University of Strasbourg, Faculty of Medicine, Translational Medicine Federation (FMTS), UR 3072, France; University Hospitals of Strasbourg, Physiology and Functional Explorations Department, Civil Hospital, France.'}, {'ForeName': 'Stéphane P', 'Initials': 'SP', 'LastName': 'Dufour', 'Affiliation': 'University of Strasbourg, Faculty of Medicine, Translational Medicine Federation (FMTS), UR 3072, France; University of Strasbourg, Faculty of Sport Sciences, France.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.06.004'] 792,32656738,Dynamic Eye Tracking as a Predictor and Outcome Measure of Social Skills Intervention in Adolescents and Adults with Autism Spectrum Disorder.,"To evaluate an eye tracking task as a predictor and outcome measure of treatment response for autism spectrum disorder (ASD) social skills interventions, adolescents and young adults with ASD completed the eye tracking task before, immediately after, and two months after completing Social Cognition and Interaction Training for Autism (SCIT-A). The study compared SCIT-A participants (n = 20) to participants with ASD who received treatment as usual (TAU; n = 21). Overall, increased visual attention to faces and background objects and decreased attention to hands playing with toys at baseline were associated with improved social functioning immediately following intervention, suggesting this eye tracking task may reliably predict ASD social intervention outcomes.",2021,"Overall, increased visual attention to faces and background objects and decreased attention to hands playing with toys at baseline were associated with improved social functioning immediately following intervention, suggesting this eye tracking task may reliably predict ASD social intervention outcomes.","['Adolescents and Adults with Autism Spectrum Disorder', 'autism spectrum disorder (ASD) social skills interventions, adolescents and young adults with ASD']",['Social Skills Intervention'],"['visual attention to faces and background objects and decreased attention to hands playing with toys', 'social functioning']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0589102', 'cui_str': 'Visual attention'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0040565', 'cui_str': 'Toy'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}]",,0.0620067,"Overall, increased visual attention to faces and background objects and decreased attention to hands playing with toys at baseline were associated with improved social functioning immediately following intervention, suggesting this eye tracking task may reliably predict ASD social intervention outcomes.","[{'ForeName': 'Rachel K', 'Initials': 'RK', 'LastName': 'Greene', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Parish-Morris', 'Affiliation': ""Center for Autism Research, Children's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.""}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Sullivan', 'Affiliation': 'Carolina Institute for Developmental Disabilities, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Kinard', 'Affiliation': 'Carolina Institute for Developmental Disabilities, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Maya G', 'Initials': 'MG', 'LastName': 'Mosner', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Turner-Brown', 'Affiliation': 'TEACCH Autism Program, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Penn', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Wiesen', 'Affiliation': 'The Odum Institute, The University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Ashley A', 'Initials': 'AA', 'LastName': 'Pallathra', 'Affiliation': 'Center for Neurobiology and Behavior, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Brodkin', 'Affiliation': 'Center for Neurobiology and Behavior, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Schultz', 'Affiliation': ""Center for Autism Research, Children's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.""}, {'ForeName': 'Gabriel S', 'Initials': 'GS', 'LastName': 'Dichter', 'Affiliation': 'Carolina Institute for Developmental Disabilities, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA. dichter@med.unc.edu.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04594-1'] 793,32641142,Efficacy and safety of the extracorporeal shockwave therapy in patients with postherpetic neuralgia: study protocol of a randomized controlled trial.,"BACKGROUND Postherpetic neuralgia (PHN) is one of the most common types of chronic neuropathic pain, which seriously affects quality of the life because of pain severity and poor response to the currently available treatments. The main strategies for PHN management are medication and invasive interventional therapies; however, these approaches have many adverse effects, so it is important to find another effective and safe treatment for PHN. METHODS A single-center, single-blind randomized clinical trial will evaluate 98 study participants randomized in a 1:1 ratio into control and experimental groups. The control group will receive conventional treatment including medication therapy and invasive interventional therapy. The experimental group will receive extracorporeal shockwave therapy (ESWT) in addition to conventional therapy. The primary outcome is pain intensity assessed on a visual analogue scale (VAS); the secondary outcomes are the following: quality of life assessed by the 36-Item Short-Form Health Survey (SF-36), psychological state for anxiety and depression measured by the Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS), and sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI). Assessors blinded to the randomization will collect data during the intervention period at baseline and weeks 1, 4, and 12. The plasma levels of tumor necrosis factor-α and interleukin-6 will be assessed before and after ESWT to explore the biochemical mechanisms of ESWT in the treatment of PHN. DISCUSSION This randomized controlled trial will evaluate the effectiveness and safety of ESWT in patients with PHN and thus will provide clinical evidence for its use in the management of PHN and explore the potential biochemical mechanisms of this treatment. TRIAL REGISTRATION www.ChiCTR.org.cn , identifier: ChiCTR1900025828. Registered on 10 September 2019.",2020,"Assessors blinded to the randomization will collect data during the intervention period at baseline and weeks 1, 4, and 12.","['patients with postherpetic neuralgia', 'patients with PHN']","['ESWT', 'extracorporeal shockwave therapy (ESWT', 'conventional treatment including medication therapy and invasive interventional therapy', 'extracorporeal shockwave therapy']","['pain intensity assessed on a visual analogue scale (VAS); the secondary outcomes are the following: quality of life assessed by the 36-Item Short-Form Health Survey (SF-36), psychological state for anxiety and depression measured by the Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS), and sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI', 'Efficacy and safety', 'plasma levels of tumor necrosis factor-α and interleukin-6']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032768', 'cui_str': 'Postherpetic neuralgia'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",98.0,0.0776759,"Assessors blinded to the randomization will collect data during the intervention period at baseline and weeks 1, 4, and 12.","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""Department of Pain Management, West China Hospital, Sichuan University, Guoxuexiang No. 37, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Ruihao', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': ""Department of Pain Management, West China Hospital, Sichuan University, Guoxuexiang No. 37, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Fuguo', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': ""Department of Pain Management, West China Hospital, Sichuan University, Guoxuexiang No. 37, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Weng', 'Affiliation': ""Department of Pain Management, West China Hospital, Sichuan University, Guoxuexiang No. 37, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Ye', 'Affiliation': ""Department of Pain Management, West China Hospital, Sichuan University, Guoxuexiang No. 37, Chengdu, 610041, People's Republic of China. zerodq_hx@163.com.""}, {'ForeName': 'Pingliang', 'Initials': 'P', 'LastName': 'Yang', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Chengdu Medical College, Xindu, 610500, Sichuan, People's Republic of China. pingliangyang@163.com.""}]",Trials,['10.1186/s13063-020-04564-z'] 794,32651711,Safety of one-stage bilateral total knee arthroplasty -one surgeon sequential vs. two surgeons simultaneous: a randomized controlled study.,"PURPOSE This study aimed to examine the complications by comparing two surgeons simultaneous bilateral total knee arthroplasty (two-surgeon bilateral TKA) to one surgeon sequential bilateral total knee arthroplasty (single-surgeon bilateral TKA). METHODS Two hundred forty-six participants were prospectively randomized into two groups: two-surgeon bilateral TKA and single-surgeon bilateral TKA. While two surgeons performed simultaneous total knee arthroplasty in the two-surgeon bilateral TKA group, one surgeon performed sequentially in the single-surgeon bilateral TKA group. Ninety-day major, and minor complications rate, operative time, estimated blood loss (EBL) and patient-reported outcome measures were analysed. RESULTS The two surgeons operated in two-surgeon bilateral TKA group 246 knees in 123 patients, while the single surgeon operated in single-surgeon bilateral TKA group 246 knees of 123 patients. The median operating time was 120 (range 70-151) minutes in the two-surgeon bilateral TKA group and 140 (range 75-190) minutes in the single-surgeon bilateral TKA group (p < 0.001). The median EBL was higher in the two-surgeon bilateral TKA group (p < 0.001). The 90-day complications were two major complications (1.6%) in the two-surgeon bilateral TKA group and 11 (8.9%) in the single-surgeon bilateral TKA group (p = 0.01). CONCLUSION Two-surgeon simultaneous bilateral TKA is a safe method with lower complication rates compared with single-surgeon sequential bilateral TKA and can be preferred for experienced teams. However, peri- and post-operative care is required to decrease the risk of bleeding, particularly in patients undergoing two-surgeon simultaneous bilateral TKA. TRIAL REGISTRATION This study was retrospectively registered in a public trials registry ( https://clinicaltrials.gov/ , NCT04299516).",2020,The median EBL was higher in the two-surgeon bilateral TKA group (p < 0.001).,"['group 246 knees of 123 patients', 'Two hundred forty-six participants']","['two-surgeon bilateral TKA and single-surgeon bilateral TKA', 'single surgeon operated in single-surgeon bilateral TKA', 'surgeons simultaneous bilateral total knee arthroplasty (two-surgeon bilateral TKA', 'one-stage bilateral total knee arthroplasty\xa0-one surgeon sequential vs. two surgeons simultaneous', 'surgeon sequential bilateral total knee arthroplasty (single-surgeon bilateral TKA']","['complication rates', '90-day complications', 'minor complications rate, operative time, estimated blood loss (EBL', 'median EBL', 'risk of bleeding', 'median operating time', 'simultaneous total knee arthroplasty']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]",246.0,0.188458,The median EBL was higher in the two-surgeon bilateral TKA group (p < 0.001).,"[{'ForeName': 'Gökçer', 'Initials': 'G', 'LastName': 'Uzer', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, İskender Paşa Mh Adnan Menderes Bulvarı, Adnan Menderes Blv., Fatih, 34093, İstanbul, Turkey.'}, {'ForeName': 'Orkhan', 'Initials': 'O', 'LastName': 'Aliyev', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, İskender Paşa Mh Adnan Menderes Bulvarı, Adnan Menderes Blv., Fatih, 34093, İstanbul, Turkey.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Yıldız', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, İskender Paşa Mh Adnan Menderes Bulvarı, Adnan Menderes Blv., Fatih, 34093, İstanbul, Turkey. yildizfatih@hotmail.com.'}, {'ForeName': 'Nurdan', 'Initials': 'N', 'LastName': 'Güngören', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, İskender Paşa Mh Adnan Menderes Bulvarı, Adnan Menderes Blv., Fatih, 34093, İstanbul, Turkey.'}, {'ForeName': 'Nurzat', 'Initials': 'N', 'LastName': 'Elmalı', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, İskender Paşa Mh Adnan Menderes Bulvarı, Adnan Menderes Blv., Fatih, 34093, İstanbul, Turkey.'}, {'ForeName': 'İbrahim', 'Initials': 'İ', 'LastName': 'Tuncay', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, İskender Paşa Mh Adnan Menderes Bulvarı, Adnan Menderes Blv., Fatih, 34093, İstanbul, Turkey.'}]",International orthopaedics,['10.1007/s00264-020-04704-9'] 795,32652544,Long-term efficacy of certolizumab pegol for the treatment of plaque psoriasis: 3-year results from two randomized phase III trials (CIMPASI-1 and CIMPASI-2).,"BACKGROUND Certolizumab pegol (CZP) is an Fc-free, PEGylated anti-tumour necrosis factor biologic. OBJECTIVES To report the 3-year efficacy of CZP in plaque psoriasis, pooled from the CIMPASI-1 (NCT02326298) and CIMPASI-2 (NCT02326272) phase III trials. METHODS Adults with moderate-to-severe psoriasis for ≥ 6 months were randomized 2 : 2 : 1 to CZP 200 mg, CZP 400 mg or placebo, every 2 weeks (Q2W) for up to 48 weeks. Patients entering the open-label period (weeks 48-144) from double-blinded CZP initially received CZP 200 mg Q2W. Patients not achieving ≥ 50% improvement in Psoriasis Area and Severity Index (PASI 50) at week 16 entered an open-label CZP 400 mg Q2W escape arm (weeks 16-144). Dose adjustments based on PASI response were permitted during open-label treatment. Outcomes included PASI 75, PASI 90 and Physician's Global Assessment (PGA) 0/1 responder rates, based on a logistic regression model (missing data imputed using Markov Chain Monte Carlo methodology). RESULTS In total, 186 patients were randomized to CZP 200 mg Q2W and 175 to CZP 400 mg Q2W. At week 48, PASI 75/90 was achieved by 72·7%/51·3% of patients randomized to CZP 200 mg and 84·4%/62·7% randomized to CZP 400 mg. Patients entering the open-label period at week 48, from blinded treatment, received CZP 200 mg Q2W. At week 144, PASI 75/90 was achieved by 70·6%/48·7% patients randomized to CZP 200 mg and 72·9%/42·7% randomized to CZP 400 mg. At week 16, 72 placebo-randomized patients entered the CZP 400 mg Q2W escape arm; 75.7%/58.5% achieved PASI 75/90 at week 144. CONCLUSIONS Both CZP 200 mg and 400 mg Q2W demonstrated sustained, durable efficacy, with numerically higher responses for some outcomes with 400 mg Q2W.",2021,"At Week 48, PASI 75/90 was achieved by 72.7%/51.3% CZP 200 mg-randomised and 84.4%/62.7% CZP 400 mg-randomised patients.","['Plaque Psoriasis', 'Adults with moderate to severe PSO for ≥6 months', '186 patients']","['CZP 400 mg Q2W', 'Certolizumab Pegol', 'CZP 200 mg Q2W', 'CZP', 'Certolizumab pegol (CZP', 'CZP 200 mg Q2W. Patients not achieving Week 16 PASI 50 entered an open-label CZP 400 mg Q2W escape', 'CZP 200 mg, CZP 400 mg, placebo']","['PASI\xa075, PASI\xa090, and PGA 0/1 responder rates', 'Psoriasis Area and Severity Index (PASI) response', 'durable efficacy']","[{'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1872109', 'cui_str': 'certolizumab pegol'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C4026841', 'cui_str': 'certolizumab pegol 200 MG'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",186.0,0.321058,"At Week 48, PASI 75/90 was achieved by 72.7%/51.3% CZP 200 mg-randomised and 84.4%/62.7% CZP 400 mg-randomised patients.","[{'ForeName': 'K B', 'Initials': 'KB', 'LastName': 'Gordon', 'Affiliation': 'Department of Dermatology, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Warren', 'Affiliation': 'Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, The University of Manchester, Manchester, UK.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Gottlieb', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, OR, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Thaçi', 'Affiliation': 'Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Leonardi', 'Affiliation': 'Central Dermatology and Saint Louis University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Poulin', 'Affiliation': 'Centre de Recherche Dermatologique du Québec Métropolitain, Québec, QC, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Boehnlein', 'Affiliation': 'UCB Pharma, Monheim, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Brock', 'Affiliation': 'UCB Pharma, Slough, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ecoffet', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf and Skinflammation® Center, Hamburg, Germany.'}]",The British journal of dermatology,['10.1111/bjd.19393'] 796,32653031,Oral intermittent vitamin D substitution: influence of pharmaceutical form and dosage frequency on medication adherence: a randomized clinical trial.,"BACKGROUND To assess adherence to and preference for vitamin D substitution with different pharmaceutical forms and frequencies of administration. METHODS A focus group of stakeholders aimed at preparing the design of an interventional, randomized, cross-over study with 2 × 2 groups obtaining monthly or weekly vitamin D products in liquid or solid form for 3 months each. Dosage corresponds to cumulated amount of recommended 800 IU daily (5.600 IU weekly / 24.000 IU monthly). Main inclusion criteria were a vitamin D serum value < 50 nmol/l and age ≥ 18 years. Primary endpoint was adherence, secondary endpoints were preferences and vitamin D serum levels. RESULTS The focus group reached consensus for preference of a monthly administration of solid forms to adults. Full datasets were obtained from 97 participants. Adherence was significantly higher with monthly (79.5-100.0%) than weekly (66.4-98.1%) administration. Vitamin D levels increased significantly (p < 0.001) in all participants. An optimal value of > 75 nmol/l was achieved by 32% after 3 months and by 50% after 6 months. Preferred formulation was solid form (tablets, capsules) for 71% of participants, and preferred dosage frequency was monthly for 39% of participants. CONCLUSIONS Monthly oral vitamin D in solid form lead to the highest adherence, and is preferred by the participants. However, only one third of study participants achieved values in the optimal range of > 75 nmol/l cholecalciferol using weekly or monthly administration providing an average daily cholecalciferol dose of 800 IU. TRIAL REGISTRATION NCT03121593 | SNCTP000002251 . Registered 30. May 2017,. Prospectively registered.",2020,Adherence was significantly higher with monthly (79.5-100.0%) than weekly (66.4-98.1%) administration.,['Main inclusion criteria were a vitamin D serum value <\u200950\u2009nmol/l and age\u2009≥\u200918\u2009years'],['Oral intermittent vitamin D substitution'],"['Vitamin D levels', 'preferences and vitamin D serum levels', 'Adherence', 'medication adherence']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439282', 'cui_str': 'nmol/L'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",,0.251136,Adherence was significantly higher with monthly (79.5-100.0%) than weekly (66.4-98.1%) administration.,"[{'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Rothen', 'Affiliation': 'Pharmaceutical Care Research Group, Department of Pharmaceutical Sciences, University of Basel, Petersplatz 14, Postfach 2148, CH-4001, Basel, Switzerland. jp.rothen@unibas.ch.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Rutishauser', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, University Hospital, Basel, Switzerland.'}, {'ForeName': 'Philipp N', 'Initials': 'PN', 'LastName': 'Walter', 'Affiliation': 'Solothurn Hospitals, Institute for Laboratory Medicine, Olten, Switzerland.'}, {'ForeName': 'Kurt E', 'Initials': 'KE', 'LastName': 'Hersberger', 'Affiliation': 'Pharmaceutical Care Research Group, Department of Pharmaceutical Sciences, University of Basel, Petersplatz 14, Postfach 2148, CH-4001, Basel, Switzerland.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Arnet', 'Affiliation': 'Pharmaceutical Care Research Group, Department of Pharmaceutical Sciences, University of Basel, Petersplatz 14, Postfach 2148, CH-4001, Basel, Switzerland.'}]",BMC pharmacology & toxicology,['10.1186/s40360-020-00430-5'] 797,32656706,Development of a new risk model for a prognostic prediction after transcatheter aortic valve replacement.,"BACKGROUND Current guidelines for transcatheter aortic valve replacement (TAVR) recommend that TAVR should be performed in patients with a life expectancy > 1 year. However, it is challenging to estimate the patients' life expectancy because it is related to various factors, including frailty and nutritional status. HYPOTHESIS A new risk model can estimate the prognosis of patients after TAVR. METHODS We randomly divided 388 patients with aortic stenosis (AS) undergoing TAVR from October 2009 to August 2016 into two groups (2:1 ratio; training cohort, 259; validation cohort, 129). Using 94 baseline factors in the training cohort, we developed possible scoring models by the Cox proportional hazard regression model with the overall survival as the endpoint. Then, cross-validated 5-year C-statistics were calculated to assess the accuracy of the model. RESULTS Of 94 baseline factors, 12 factors were finally identified (5-year C-statistics in the training cohort: 0.709)-age, gender, body mass index, left ventricular ejection fraction, % vital capacity, forced expiratory volume 1.0 (s) %, albumin, hemoglobin, creatine, platelet, creatine kinase, and prothrombin time-international normalized ratio. The cross-validated 1-, 3-, and 5-year C-statistics in the validation cohort were 0.792, 0.758, and 0.778, respectively. Furthermore, calibration plots in the validation cohort revealed that 5-year survival is well predicted (r = 0.962). CONCLUSIONS The new survival prediction model after TAVR could provide appropriate guidance during decision making regarding the TAVR implementation.",2021,"Furthermore, calibration plots in the validation cohort revealed that 5-year survival is well predicted (r = 0.962). ","['patients with a\xa0life expectancy\u2009>\u20091\xa0year', '388 patients with aortic stenosis (AS) undergoing TAVR from October 2009 to August 2016 into two groups (2:1 ratio; training cohort, 259; validation cohort, 129']","['transcatheter aortic valve replacement (TAVR', 'transcatheter aortic valve replacement']","['5-year survival', 'body mass index, left ventricular ejection fraction, % vital capacity, forced expiratory volume 1.0 (s) %, albumin, hemoglobin, creatine, platelet, creatine kinase, and prothrombin time-international normalized ratio']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}]","[{'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0042834', 'cui_str': 'Vital capacity'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}]",388.0,0.0323344,"Furthermore, calibration plots in the validation cohort revealed that 5-year survival is well predicted (r = 0.962). ","[{'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Maeda', 'Affiliation': 'Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Kuratani', 'Affiliation': 'Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Kyongsun', 'Initials': 'K', 'LastName': 'Pak', 'Affiliation': 'Division of Biostatistics, Center for Clinical Research, National Center for Child Health and Development, Setagaya, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Shimamura', 'Affiliation': 'Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Isamu', 'Initials': 'I', 'LastName': 'Mizote', 'Affiliation': 'Department of Cardiology, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Miyagawa', 'Affiliation': 'Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Toda', 'Affiliation': 'Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Sakata', 'Affiliation': 'Division of Biostatistics, Center for Clinical Research, National Center for Child Health and Development, Setagaya, Japan.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Sawa', 'Affiliation': 'Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita, Osaka, 565-0871, Japan. sawa-p@surg1.med.osaka-u.ac.jp.'}]",General thoracic and cardiovascular surgery,['10.1007/s11748-020-01436-w'] 798,32656729,"Liraglutide Augments Weight Loss After Laparoscopic Sleeve Gastrectomy: a Randomised, Double-Blind, Placebo-Control Study.","PURPOSE Both laparoscopic sleeve gastrectomy (LSG) and liraglutide cause a significant weight loss. We evaluated the effect of liraglutide in comparison with placebo on total weight loss (TWL) and excess body weight loss (EWL) and when added in initial weight loss period after LSG in obese individuals. MATERIAL AND METHODS Participants with BMI > 30 kg/m 2 undergoing LSG were randomised to receive either liraglutide (subcutaneous) in increasing does of 0.6 mg/day until maximum tolerated dose of 3.0 mg (L-L group) or placebo (L-P group) from 6 weeks post-operative until 6 months. Weight, BMI, %TWL, %EWL, HbA1c, fasting plasma glucose, HOMA-IR, resolution of type 2 diabetes mellitus, hypertension, dyslipidaemia, sleep apnea and quality of life were evaluated. Primary end point was %TWL and % EWL at post-operative 6 months. RESULTS Thirty participants underwent LSG, and 23 were randomised to receive liraglutide (n = 12) or placebo (n = 11).The mean dose of liraglutide in L-L group was 1.41 ± 0.49 mg/day. Patients in L-L group had %TWL of 28.2 ± 5.7 and %EWL of 58.7 ± 14.3 as compared with 23.2 ± 6.2 (p = 0.116) and 44.5 ± 8.6 (p = 0.043) in L-P group at 24 weeks, respectively. BMI decreased by 11.7 ± 3.5 in L-L group compared with 9.5 ± 4.0 in L-P group (p = 0.287). All patients with diabetes or pre-diabetes had resolution of dysglycemia in the L-L group as compared with 50% in L-P group. However, there was no significant difference in resolution of other obesity-related comorbidities between two groups at 24-week follow-up. CONCLUSION Liraglutide added early after LSG significantly augments weight loss from LSG in obese individuals. TRIAL REGISTRATION The study protocol was registered at clinical trials.gov.in with NCT: 04325581.",2021,"However, there was no significant difference in resolution of other obesity-related comorbidities between two groups at 24-week follow-up. ","['Thirty participants underwent', 'obese individuals', 'Participants with BMI >\u200930\xa0kg', 'm 2 undergoing LSG']","['laparoscopic sleeve gastrectomy (LSG) and liraglutide', 'Placebo', 'liraglutide', 'Laparoscopic Sleeve Gastrectomy', 'Liraglutide', 'liraglutide (subcutaneous', 'LSG', 'placebo']","['resolution of dysglycemia', 'total weight loss (TWL) and excess body weight loss (EWL', 'Weight Loss', 'Weight, BMI, %TWL, %EWL, HbA1c, fasting plasma glucose, HOMA-IR, resolution of type 2 diabetes mellitus, hypertension, dyslipidaemia, sleep apnea and quality of life', 'BMI', 'weight loss', 'resolution of other obesity-related comorbidities']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C1960636', 'cui_str': 'Dysglycemia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439175', 'cui_str': '% of total'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0348480', 'cui_str': 'Other obesity'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]",30.0,0.171454,"However, there was no significant difference in resolution of other obesity-related comorbidities between two groups at 24-week follow-up. ","[{'ForeName': 'Uttam', 'Initials': 'U', 'LastName': 'Thakur', 'Affiliation': 'Department of Gastro-intestinal Surgery, PGIMER, Chandigarh, Chandigarh, India.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Bhansali', 'Affiliation': 'Department of Endocrinology, PGIMER, Chandigarh, Room-1011, Nehru Hospital Extension Block, Chandigarh, 160012, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Department of Gastro-intestinal Surgery, PGIMER, Chandigarh, Chandigarh, India.'}, {'ForeName': 'Ashu', 'Initials': 'A', 'LastName': 'Rastogi', 'Affiliation': 'Department of Endocrinology, PGIMER, Chandigarh, Room-1011, Nehru Hospital Extension Block, Chandigarh, 160012, India. ashuendo@gmail.com.'}]",Obesity surgery,['10.1007/s11695-020-04850-4'] 799,32648022,"Short-term, but not acute, intake of New Zealand blackcurrant extract improves insulin sensitivity and free-living postprandial glucose excursions in individuals with overweight or obesity.","Impaired postprandial glucose handling and low-grade systemic inflammation are risk factors for developing insulin resistance in individuals with overweight or obesity. Acute ingestion of anthocyanins improves postprandial glucose responses to a single carbohydrate-rich meal under strictly controlled conditions. PURPOSE Examine whether acute and short-term supplementation with anthocyanin-rich New Zealand blackcurrant (NZBC) extract can improve postprandial glucose responses to mixed-macronutrient meals. METHODS Twenty-five overweight (BMI > 25 kg m 2 ) sedentary individuals participated in one of the following double-blinded, randomised controlled trials: (1) ingestion of 600 mg NZBC extract or placebo prior to consumption of a high-carbohydrate, high-fat liquid meal (n = 12); (2) 8-days supplementation with NZBC extract (600 mg day -1 ) or placebo, with insulin sensitivity and markers of inflammation assessed on day-7, and free-living postprandial glucose (continuous glucose monitoring) assessed on day-8 (n = 13). RESULTS A single dose of NZBC extract had no effect on 3 h postprandial glucose, insulin or triglyceride responses. However, in response to short-term NZBC extract supplementation insulin sensitivity was improved (+ 22%; P = 0.011), circulating C-reactive protein concentrations decreased (P = 0.008), and free-living postprandial glucose responses to both breakfast and lunch meals were reduced (- 9% and - 8%, respectively; P < 0.05), compared to placebo. CONCLUSION These novel results indicate that repeated intake, rather than a single dose of NZBC extract, is required to induce beneficial effects on insulin sensitivity and postprandial glucose handling in individuals with overweight or obesity. Continuous glucose monitoring enabled an effect of NZBC extract to be observed under free-living conditions and highlights the potential of anthocyanin-rich supplements as a viable strategy to reduce insulin resistance.",2021,Impaired postprandial glucose handling and low-grade systemic inflammation are risk factors for developing insulin resistance in individuals with overweight or obesity.,"['Twenty-five', 'overweight', 'individuals with overweight or obesity']","['placebo, with insulin sensitivity and markers of inflammation assessed on day-7, and free-living postprandial glucose (continuous glucose monitoring) assessed on day-8 (n\u2009=\u200913', 'anthocyanins', 'NZBC extract', 'anthocyanin-rich New Zealand blackcurrant (NZBC) extract', 'NZBC extract or placebo prior to consumption of a high-carbohydrate, high-fat liquid meal (n\u2009=\u200912); (2) 8-days supplementation with NZBC extract']","['insulin sensitivity and free-living postprandial glucose excursions', 'circulating C-reactive protein concentrations', 'free-living postprandial glucose responses to both breakfast and lunch meals', '3\xa0h postprandial glucose, insulin or triglyceride responses', 'NZBC extract supplementation insulin sensitivity', 'postprandial glucose responses']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0453277', 'cui_str': 'Blackcurrants'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0453277', 'cui_str': 'Blackcurrants'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]",,0.180277,Impaired postprandial glucose handling and low-grade systemic inflammation are risk factors for developing insulin resistance in individuals with overweight or obesity.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nolan', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Brett', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Strauss', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'C E', 'Initials': 'CE', 'LastName': 'Stewart', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'S O', 'Initials': 'SO', 'LastName': 'Shepherd', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK. S.Shepherd@ljmu.ac.uk.'}]",European journal of nutrition,['10.1007/s00394-020-02329-7'] 800,32644875,Effects of Estradiol Dose and Serum Estradiol Levels on Metabolic Measures in Early and Late Postmenopausal Women in the REPLENISH Trial.,"Background: To identify the association of estradiol (E2) dose and serum E2 levels with metabolic measures in early (<6 years) compared with late (≥10 years) postmenopausal women from the REPLENISH trial. Material and Methods: This is a post hoc analysis of a multicenter randomized clinical trial in the United States. Four doses of TX-001HR, an oral combination of E2 and progesterone (P4), and placebo were tested. This analysis included a total of 1,216 early and 297 late postmenopausal women. Linear mixed-effects models tested the association of E2 dose and serum E2 levels with changes in metabolic parameters; total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglyceride (TG), and glucose (GLUC) levels from six visits over 12 months, adjusted for the serum P4 level. Results: A higher E2 dose was significantly associated with lower TC ( p  = 0.02) and LDL-C ( p  = 0.002) and higher HDL-C ( p  = 0.04) levels in early, but not late, postmenopause. With longer time since menopause, the inverse association of E2 dose with TC and LDL-C and positive association with HDL-C were attenuated (interaction p  < 0.05). Higher serum E2 levels were significantly associated with lower TC ( p  = 0.004), LDL-C ( p  = 0.0001), and fasting blood GLUC ( p  = 0.003) and higher TG ( p  = 0.002) levels in early postmenopause. Conclusion: E2 dose differentially affects metabolic measures among early compared with late postmenopausal women. No significant main effect of the serum P4 level was found. As the metabolic parameters studied are risk factors for cardiovascular events, these results support the timing hypothesis of E2 therapy and its cardiovascular benefits.",2020,"Higher serum E2 levels were significantly associated with lower TC ( p  = 0.004), LDL-C ( p  = 0.0001), and fasting blood GLUC ( p  = 0.003) and higher TG ( p  = 0.002) levels in early postmenopause. ","['early (<6 years) compared with late (≥10 years', 'Early and Late Postmenopausal Women', 'postmenopausal women', 'late postmenopausal women', '1,216 early and 297 late postmenopausal women']","['Estradiol Dose and Serum Estradiol Levels', 'TX-001HR, an oral combination of E2 and progesterone (P4), and placebo']","['fasting blood GLUC', 'serum P4 level', 'association of estradiol (E2) dose and serum E2 levels with metabolic measures', 'LDL-C', 'Higher serum E2 levels', 'metabolic measures', 'metabolic parameters; total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglyceride (TG), and glucose (GLUC) levels']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C4279222', 'cui_str': 'TX-001HR'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",1216.0,0.0619169,"Higher serum E2 levels were significantly associated with lower TC ( p  = 0.004), LDL-C ( p  = 0.0001), and fasting blood GLUC ( p  = 0.003) and higher TG ( p  = 0.002) levels in early postmenopause. ","[{'ForeName': 'Intira', 'Initials': 'I', 'LastName': 'Sriprasert', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Howard N', 'Initials': 'HN', 'LastName': 'Hodis', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Bernick', 'Affiliation': 'TherapeuticsMD, Boca Raton, Florida, USA.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Mirkin', 'Affiliation': 'TherapeuticsMD, Boca Raton, Florida, USA.'}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Mack', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.'}]",Journal of women's health (2002),['10.1089/jwh.2019.8238'] 801,32646482,Effect of dietary myo-inositol supplementation on the insulin resistance and the prevention of gestational diabetes mellitus: study protocol for a randomized controlled trial.,"BACKGROUND Gestational diabetes mellitus (GDM) is defined as impaired glucose tolerance with onset or first recognition during pregnancy, which is characterized by an increased insulin resistance. Gestational diabetes mellitus is associated with pregnancy-related maternal and fetal morbidity (both antenatal and perinatal). Myo-inositol has been suggested to improve insulin resistance in women with polycystic ovary syndrome. The aim of this study is to examine the impact of myo-inositol supplementation during pregnancy on the incidence of gestational diabetes mellitus. METHODS We will conduct a single-center, open-label, randomized controlled trial. A total of 160 healthy pregnant women with singleton pregnancy at 11-13 +6 weeks of gestation will be randomly allocated in two groups: intervention group (N = 80) and control group (N = 80). The intervention group will receive myo-inositol and folic acid (4000 mg myo-inositol and 400 mcg folic acid daily) from 11 to 13 +6 weeks of gestation until 26-28 weeks of gestation, while the control group will receive folic acid alone (400 mcg folic acid daily) for the same period of time as intervention group. The primary outcome will be gestational diabetes incidence rate at 26-28 weeks of gestation, according to the results of a 75 g oral glucose tolerance test held at 26-28 weeks of gestation. The secondary outcomes will include fasting blood glucose levels, glycated hemoglobin levels, insulin resistance level (evaluated by homeostasis model assessment of insulin resistance and Matsuda Index), and incidence rate of diet-treated gestational diabetes and diabetes requiring insulin therapy at 26-28 weeks of gestation. DISCUSSION This trial will provide evidence for the effectiveness of myo-inositol supplementation during pregnancy in reducing the incidence of gestational diabetes mellitus. TRIAL REGISTRATION ISRCTN registry: ISRCTN16142533 . Registered on 9 March 2017.",2020,A total of 160 healthy pregnant women with singleton pregnancy at 11-13 +6 weeks of gestation will be randomly allocated in two groups: intervention group (N = 80) and control group (N = 80).,"['gestational diabetes mellitus', '160 healthy pregnant women with singleton pregnancy at 11-13 +6 weeks of gestation', 'women with polycystic ovary syndrome', 'Gestational diabetes mellitus', 'Gestational diabetes mellitus (GDM']","['myo-inositol and folic acid (4000\u2009mg myo-inositol and 400\xa0mcg folic acid daily', 'folic acid alone', 'dietary myo-inositol supplementation', 'myo-inositol supplementation']","['insulin resistance', 'fasting blood glucose levels, glycated hemoglobin levels, insulin resistance level (evaluated by homeostasis model assessment of insulin resistance and Matsuda Index), and incidence rate of diet-treated gestational diabetes and diabetes requiring insulin therapy', 'gestational diabetes incidence rate']","[{'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}]","[{'cui': 'C0021547', 'cui_str': 'Inositol'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C3842327', 'cui_str': '4000'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}]",160.0,0.176481,A total of 160 healthy pregnant women with singleton pregnancy at 11-13 +6 weeks of gestation will be randomly allocated in two groups: intervention group (N = 80) and control group (N = 80).,"[{'ForeName': 'George', 'Initials': 'G', 'LastName': 'Asimakopoulos', 'Affiliation': 'First Department of Obstetrics and Gynecology, National and Kapodistrian University of Athens, Alexandra Hospital, 80 Vasilissis Sofias Avenue, Athens, Greece. asimakopoulos.geo5@gmail.com.'}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Pergialiotis', 'Affiliation': 'First Department of Obstetrics and Gynecology, National and Kapodistrian University of Athens, Alexandra Hospital, 80 Vasilissis Sofias Avenue, Athens, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Anastasiou', 'Affiliation': 'Endocrine Section - Diabetes Centre, Alexandra Hospital, 80 Vasilissis Sofias Avenue, Athens, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Antsaklis', 'Affiliation': 'First Department of Obstetrics and Gynecology, National and Kapodistrian University of Athens, Alexandra Hospital, 80 Vasilissis Sofias Avenue, Athens, Greece.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Theodora', 'Affiliation': 'First Department of Obstetrics and Gynecology, National and Kapodistrian University of Athens, Alexandra Hospital, 80 Vasilissis Sofias Avenue, Athens, Greece.'}, {'ForeName': 'Evangelia', 'Initials': 'E', 'LastName': 'Vogiatzi', 'Affiliation': 'Endocrine Section - Diabetes Centre, Alexandra Hospital, 80 Vasilissis Sofias Avenue, Athens, Greece.'}, {'ForeName': 'Aggela', 'Initials': 'A', 'LastName': 'Kallergi', 'Affiliation': 'Endocrine Section - Diabetes Centre, Alexandra Hospital, 80 Vasilissis Sofias Avenue, Athens, Greece.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sindos', 'Affiliation': 'First Department of Obstetrics and Gynecology, National and Kapodistrian University of Athens, Alexandra Hospital, 80 Vasilissis Sofias Avenue, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Loutradis', 'Affiliation': 'First Department of Obstetrics and Gynecology, National and Kapodistrian University of Athens, Alexandra Hospital, 80 Vasilissis Sofias Avenue, Athens, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Daskalakis', 'Affiliation': 'First Department of Obstetrics and Gynecology, National and Kapodistrian University of Athens, Alexandra Hospital, 80 Vasilissis Sofias Avenue, Athens, Greece.'}]",Trials,['10.1186/s13063-020-04561-2'] 802,32656994,A Factorial Experiment to Optimize Remotely Delivered Behavioral Treatment for Obesity: Results of the Opt-IN Study.,"OBJECTIVE Intensive behavioral obesity treatments face scalability challenges, but evidence is lacking about which treatment components could be cut back without reducing weight loss. The Optimization of Remotely Delivered Intensive Lifestyle Treatment for Obesity (Opt-IN) study applied the Multiphase Optimization Strategy to develop an entirely remotely delivered, technology-supported weight-loss package to maximize the amount of weight loss attainable for ≤$500. METHODS Six-month weight loss was examined among adults (N = 562) with BMI ≥ 25 who were randomly assigned to conditions in a factorial experiment crossing five dichotomous treatment components set to either low/high (12 vs. 24 coaching calls) or off/on (primary care provider reports, text messaging, meal replacements, and buddy training). RESULTS About 84.3% of participants completed the final assessment. The treatment package yielding maximum weight loss for ≤$500 included 12 coaching calls, buddy training, and primary care provider progress reports; produced average weight loss of 6.1 kg, with 57.1% losing ≥5% and 51.8% losing ≥7%; and cost $427 per person. The most expensive candidate-treatment component (24 vs. 12 coaching calls) was screened out of the optimized treatment package because it did not increase weight loss. CONCLUSIONS Systematically testing each treatment component's effect on weight loss made it possible to eliminate more expensive but less impactful components, yielding an optimized, resource-efficient obesity treatment for evaluation in a randomized controlled trial.",2020,"Systematically testing each treatment component's effect on weight loss made it possible to eliminate more expensive but less impactful components, yielding an optimized, resource-efficient obesity treatment for evaluation in a randomized controlled trial.","['Obesity', 'Six-month weight loss was examined among adults (N\u2009=\u2009562) with BMI\u2009≥\u200925 who']","['dichotomous treatment components set to either low/high (12 vs. 24 coaching calls) or off/on (primary care provider reports, text messaging, meal replacements, and buddy training']","['average weight loss', 'weight loss']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",562.0,0.0217213,"Systematically testing each treatment component's effect on weight loss made it possible to eliminate more expensive but less impactful components, yielding an optimized, resource-efficient obesity treatment for evaluation in a randomized controlled trial.","[{'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Spring', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Angela F', 'Initials': 'AF', 'LastName': 'Pfammatter', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Sara H', 'Initials': 'SH', 'LastName': 'Marchese', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Stump', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Pellegrini', 'Affiliation': 'Department of Exercise Science, University of South Carolina, Columbia, South Carolina, USA.'}, {'ForeName': 'H Gene', 'Initials': 'HG', 'LastName': 'McFadden', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Hedeker', 'Affiliation': 'Department of Public Health Sciences, The University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Juned', 'Initials': 'J', 'LastName': 'Siddique', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Jordan', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Collins', 'Affiliation': 'The Methodology Center, Pennsylvania State University, University Park, Pennsylvania, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22915'] 803,32653577,Evaluation of platelet-rich plasma as a treatment for androgenetic alopecia: A randomized controlled trial.,"BACKGROUND Platelet-rich plasma (PRP) shows promise as an androgenetic alopecia (AGA) treatment. OBJECTIVE To conduct a randomized placebo-controlled split-scalp study to investigate the effects of PRP on hair regrowth and thickness. METHODS Two 7.6-cm × 7.6-cm squares were tattooed on the scalps of 35 study participants with AGA. Areas were randomly assigned to intradermal injection with PRP or saline. Participants received 3 monthly treatment sessions with evaluation 3 months after the final treatment. RESULTS Hair density in the PRP-treated area was significantly increased compared with baseline at all visits. At the final assessment, hair density in PRP-treated areas increased from 151 ± 39.82 hairs/cm 2 at baseline to 170.96 ± 37.14 hairs/cm 2 , a mean increase of approximately 20 hairs/cm 2 (P < .05). However, hair density in placebo-treated areas also increased from 151.04 ± 41.99 hairs/cm 2 to 166.72 ± 37.13 hairs/cm 2 (P < .05). There was no significant difference in hair density change between the 2 groups (P > .05). No serious adverse events were reported. LIMITATIONS Possible PRP diffusion due to split-scalp study design as well as microinjections causing microinjury to both sides. CONCLUSION PRP may have benefit in increasing hair density.",2020,"At the final assessment, hair density in PRP-treated areas increased from 151 ± 39.82 hairs/cm 2 at baseline to 170.96 ± 37.14 hairs/cm 2 , a mean increase of approximately 20 hairs/cm 2 (p < 0.05).","['35 study participants with AGA had two 7.6-centimeter x 7.6-centimeter squares tattooed on their scalps', 'androgenetic alopecia']","['intradermal injection with PRP or saline', 'platelet-rich plasma', 'placebo']","['hair regrowth and thickness', 'hair density in PRP-treated areas', 'serious adverse events', 'Hair density', 'hair density', 'hair density change']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}, {'cui': 'C0475210', 'cui_str': 'cm'}, {'cui': 'C0439479', 'cui_str': 'sq. cm'}, {'cui': 'C0039343', 'cui_str': 'Tattooing'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}]","[{'cui': 'C0021489', 'cui_str': 'Intradermal injection'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",35.0,0.0990235,"At the final assessment, hair density in PRP-treated areas increased from 151 ± 39.82 hairs/cm 2 at baseline to 170.96 ± 37.14 hairs/cm 2 , a mean increase of approximately 20 hairs/cm 2 (p < 0.05).","[{'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Shapiro', 'Affiliation': 'Ronald O. Perelman Department of Dermatology, New York University Grossman School of Medicine, New York, New York. Electronic address: Jerry.Shapiro@nyulangone.org.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Ho', 'Affiliation': 'Ronald O. Perelman Department of Dermatology, New York University Grossman School of Medicine, New York, New York.'}, {'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Sukhdeo', 'Affiliation': 'Pilaris Dermatology, New York, New York.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yin', 'Affiliation': 'Ronald O. Perelman Department of Dermatology, New York University Grossman School of Medicine, New York, New York.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Lo Sicco', 'Affiliation': 'Ronald O. Perelman Department of Dermatology, New York University Grossman School of Medicine, New York, New York.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.07.006'] 804,32660657,Daily mycoprotein consumption for 1 week does not affect insulin sensitivity or glycaemic control but modulates the plasma lipidome in healthy adults: a randomised controlled trial.,"Mycoprotein consumption has been shown to improve acute postprandial glycaemic control and decrease circulating cholesterol concentrations. We investigated the impact of incorporating mycoprotein into the diet on insulin sensitivity (IS), glycaemic control and plasma lipoprotein composition. Twenty healthy adults participated in a randomised, parallel-group trial in which they consumed a 7 d fully controlled diet where lunch and dinner contained either meat/fish (control group, CON) or mycoprotein (MYC) as the primary source of dietary protein. Oral glucose tolerance tests were performed pre- and post-intervention, and 24 h continuous blood glucose monitoring was applied throughout. Fasting plasma samples were obtained pre- and post-intervention and were analysed using quantitative, targeted NMR-based metabonomics. There were no changes within or between groups in blood glucose or serum insulin responses, nor in IS or 24 h glycaemic profiles. No differences between groups were found for 171 of the 224 metabonomic targets. Forty-five lipid concentrations of different lipoprotein fractions (VLDL, LDL, intermediate-density lipoprotein and HDL) remained unchanged in CON but showed a coordinated decrease (7-27 %; all P < 0·05) in MYC. Total plasma cholesterol, free cholesterol, LDL-cholesterol, HDL2-cholesterol, DHA and n-3 fatty acids decreased to a larger degree in MYC (14-19 %) compared with CON (3-11 %; P < 0·05). Substituting meat/fish for mycoprotein twice daily for 1 week did not modulate whole-body IS or glycaemic control but resulted in changes to plasma lipid composition, the latter primarily consisting of a coordinated reduction in circulating cholesterol-containing lipoproteins.",2021,"There were no changes within or between groups in blood glucose or serum insulin responses, nor in IS (Cederholm; 51±3 to 51±3 and 54±3 to 53±3 mg.","['healthy adults', 'Twenty healthy adults']","['Mycoprotein consumption', '7 d fully-controlled diet where lunch and dinner contained either meat/fish (CON) or mycoprotein (MYC']","['Fasting plasma samples', 'lipoprotein fractions (VLDL, LDL, IDL and HDL', 'Total plasma cholesterol, free-C, LDL-C, HDL2-C, DHA and omega-3 fatty acids', 'blood glucose or serum insulin responses', 'acute postprandial glycaemic control and decrease circulating cholesterol concentrations', 'Oral glucose tolerance tests', 'insulin sensitivity or glycaemic control', 'insulin sensitivity (IS), glycaemic control and plasma lipoprotein composition']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C2347312', 'cui_str': 'Mycoprotein'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C4048877', 'cui_str': 'Supper'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0016163', 'cui_str': 'Fish'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0523559', 'cui_str': 'IDL cholesterol measurement'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0858034', 'cui_str': 'Plasma cholesterol'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1847987', 'cui_str': 'Huntington disease-like 2'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0583325', 'cui_str': 'Plasma lipoprotein measurement'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",20.0,0.0269796,"There were no changes within or between groups in blood glucose or serum insulin responses, nor in IS (Cederholm; 51±3 to 51±3 and 54±3 to 53±3 mg.","[{'ForeName': 'Mariana O C', 'Initials': 'MOC', 'LastName': 'Coelho', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter,ExeterEX1 2LU, UK.'}, {'ForeName': 'Alistair J', 'Initials': 'AJ', 'LastName': 'Monteyne', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter,ExeterEX1 2LU, UK.'}, {'ForeName': 'Marlou L', 'Initials': 'ML', 'LastName': 'Dirks', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter,ExeterEX1 2LU, UK.'}, {'ForeName': 'Tim J A', 'Initials': 'TJA', 'LastName': 'Finnigan', 'Affiliation': 'Marlow Foods Ltd., StokesleyTS9 7AB, UK.'}, {'ForeName': 'Francis B', 'Initials': 'FB', 'LastName': 'Stephens', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter,ExeterEX1 2LU, UK.'}, {'ForeName': 'Benjamin T', 'Initials': 'BT', 'LastName': 'Wall', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter,ExeterEX1 2LU, UK.'}]",The British journal of nutrition,['10.1017/S0007114520002524'] 805,32660667,Effect of oral or intragastric delivery of the bitter tastant quinine on food intake and appetite sensations: a randomised crossover trial.,"Stimulation of gastrointestinal taste receptors affects eating behaviour. Intraduodenal infusion of tastants leads to increased satiation and reduced food intake, whereas intraileal infusion of tastants does not affect eating behaviour. Currently, it is unknown whether oral- or intragastric administration of tastants induces a larger effect on eating behaviour. This study investigated the effects of oral- and/or intragastric administration of quinine on food intake, appetite sensations and heart rate variability (HRV). In a blinded randomised crossover trial, thirty-two healthy volunteers participated in four interventions with a 1-week washout: oral placebo and intragastric placebo (OPGP), oral quinine and intragastric placebo (OQGP), oral placebo and intragastric quinine (OPGQ) and oral quinine and intragastric quinine (OQGQ). On test days, 150 min after a standardised breakfast, subjects ingested a capsule containing quinine or placebo and were sham-fed a mixture of quinine or placebo orally. At 50 min after intervention, subjects received an ad libitum meal to measure food intake. Visual analogue scales for appetite sensations were collected, and HRV measurements were performed at regular intervals. Oral and/or intragastric delivery of the bitter tastant quinine did not affect food intake (OPGP: 3273·6 (sem 131·8) kJ, OQGP: 3072·7 (sem 132·2) kJ, OPGQ: 3289·0 (sem 132·6) kJ and OQGQ: 3204·1 (sem 133·1) kJ, P = 0·069). Desire to eat and hunger decreased after OQGP and OPGQ compared with OPGP (P < 0·001 and P < 0·05, respectively), whereas satiation, fullness and HRV did not differ between interventions. In conclusion, sole oral sham feeding with and sole intragastric delivery of quinine decreased desire to eat and hunger, without affecting food intake, satiation, fullness or HRV.",2021,"Desire to eat and hunger decreased after OQGP and OPGQ compared with OPGP (p<.001 and p<.05, respectively), whereas satiation, fullness and HRV did not differ between interventions.",['32 healthy volunteers participated in four interventions with a one-week washout: oral'],"['OQGQ', 'placebo/intragastric placebo (OPGP), oral quinine/intragastric placebo (OQGP), oral placebo/intragastric quinine (OPGQ), and oral quinine/intragastric quinine (OQGQ', 'OPGQ', 'OPGP', 'ad libitum meal to measure food intake', 'bitter tastant quinine', 'capsule containing quinine or placebo and were sham-fed a mixture of quinine or placebo']","['Desire to eat and hunger', 'food intake OPGP', 'food intake, appetite sensations, and heart rate variability (HRV', 'Visual analogue scales for appetite sensations', 'satiation, fullness and HRV', 'desire to eat and hunger, without affecting food intake, satiation, fullness, or HRV', 'food intake and appetite sensations']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0034417', 'cui_str': 'Quinine'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0235290', 'cui_str': 'Taste bitter'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}]","[{'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",32.0,0.383977,"Desire to eat and hunger decreased after OQGP and OPGQ compared with OPGP (p<.001 and p<.05, respectively), whereas satiation, fullness and HRV did not differ between interventions.","[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Klaassen', 'Affiliation': 'Food Innovation and Health, Centre for Healthy Eating and Food Innovation, Maastricht University, 5911 AAVenlo, The Netherlands.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Keszthelyi', 'Affiliation': 'Division of Gastroenterology-Hepatology, Department of Internal Medicine, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University Medical Centre, 6202AZ Maastricht, The Netherlands.'}, {'ForeName': 'Annick M E', 'Initials': 'AME', 'LastName': 'Alleleyn', 'Affiliation': 'Division of Gastroenterology-Hepatology, Department of Internal Medicine, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University Medical Centre, 6202AZ Maastricht, The Netherlands.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Wilms', 'Affiliation': 'Division of Gastroenterology-Hepatology, Department of Internal Medicine, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University Medical Centre, 6202AZ Maastricht, The Netherlands.'}, {'ForeName': 'Aalt', 'Initials': 'A', 'LastName': 'Bast', 'Affiliation': 'Food Innovation and Health, Centre for Healthy Eating and Food Innovation, Maastricht University, 5911 AAVenlo, The Netherlands.'}, {'ForeName': 'Adrian A M', 'Initials': 'AAM', 'LastName': 'Masclee', 'Affiliation': 'Division of Gastroenterology-Hepatology, Department of Internal Medicine, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University Medical Centre, 6202AZ Maastricht, The Netherlands.'}, {'ForeName': 'Freddy J', 'Initials': 'FJ', 'LastName': 'Troost', 'Affiliation': 'Food Innovation and Health, Centre for Healthy Eating and Food Innovation, Maastricht University, 5911 AAVenlo, The Netherlands.'}]",The British journal of nutrition,['10.1017/S0007114520002536'] 806,32660675,Combined anthocyanins and bromelain supplement improves endothelial function and skeletal muscle oxygenation status in adults: a double-blind placebo-controlled randomised crossover clinical trial.,"Anthocyanins and bromelain have gained significant attention due to their antioxidative and anti-inflammatory properties. Both have been shown to improve endothelial function, blood pressure (BP) and oxygen utility capacity in humans; however, the combination of these two and the impacts on endothelial function, BP, total antioxidant capacity (TAC) and oxygen utility capacity have not been previously investigated. The purpose of this study was to investigate the impacts of a combined anthocyanins and bromelain supplement (BE) on endothelial function, BP, TAC, oxygen utility capacity and fatigability in healthy adults. Healthy adults (n 18, age 24 (sd 4) years) received BE or placebo in a randomised crossover design. Brachial artery flow-mediated dilation (FMD), BP, TAC, resting heart rate, oxygen utility capacity and fatigability were measured pre- and post-BE and placebo intake. The BE group showed significantly increased FMD, reduced systolic BP and improved oxygen utility capacity compared with the placebo group (P < 0·05). Tissue saturation and oxygenated Hb significantly increased following BE intake, while deoxygenated Hb significantly decreased (P < 0·05) during exercise. Additionally, TAC was significantly increased following BE intake (P < 0·05). There were no significant differences for resting heart rate, diastolic BP or fatigability index. These results suggest that BE intake is an effective nutritional therapy for improving endothelial function, BP, TAC and oxygen utility capacity, which may be beneficial to support vascular health in humans.",2021,Tissue saturation and oxygenated hemoglobin significantly increased following BE intake while deoxygenated hemoglobin significantly decreased (p<0.05) during exercise.,"['adults', 'healthy adults', 'Healthy adults (n=18, age 24±4) received']","['Anthocyanins and bromelain', 'BE or placebo', 'combined anthocyanins and bromelain supplement (BE', 'TAC', 'Combined anthocyanins and bromelain supplement', 'placebo']","['endothelial function, BP, TAC, oxygen utility capacity, and fatigability', 'resting heart rate, diastolic BP, or fatigability index', 'endothelial function, BP TAC, and oxygen utility capacity', 'deoxygenated hemoglobin', 'FMD, reduced systolic BP, and improved oxygen utility capacity', 'Brachial artery flow-mediated dilation (FMD), BP, TAC, resting heart rate, oxygen utility capacity, and fatigability', 'endothelial function, BP, total antioxidant capacity (TAC), and oxygen utility capacity', 'Tissue saturation and oxygenated hemoglobin', 'endothelial function, blood pressure (BP), and oxygen utility capacity', 'endothelial function and skeletal muscle oxygenation status']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0006217', 'cui_str': 'Bromelains'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0231230', 'cui_str': 'Fatigability'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0277885', 'cui_str': 'Decreased systolic arterial pressure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.183709,Tissue saturation and oxygenated hemoglobin significantly increased following BE intake while deoxygenated hemoglobin significantly decreased (p<0.05) during exercise.,"[{'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Pekas', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska Omaha, Omaha, NE 68182, USA.'}, {'ForeName': 'Jeonghwa', 'Initials': 'J', 'LastName': 'Shin', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska Omaha, Omaha, NE 68182, USA.'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Headid', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska Omaha, Omaha, NE 68182, USA.'}, {'ForeName': 'Won-Mok', 'Initials': 'WM', 'LastName': 'Son', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska Omaha, Omaha, NE 68182, USA.'}, {'ForeName': 'Gwenael', 'Initials': 'G', 'LastName': 'Layec', 'Affiliation': 'Department of Kinesiology, University of Massachusetts Amherst, Amherst, MA01003, USA.'}, {'ForeName': 'Santosh K', 'Initials': 'SK', 'LastName': 'Yadav', 'Affiliation': 'Department of Cellular & Integrative Physiology, University of Nebraska Medical Center, Omaha, NE68198, USA.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Scott', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska Omaha, Omaha, NE 68182, USA.'}, {'ForeName': 'Song-Young', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska Omaha, Omaha, NE 68182, USA.'}]",The British journal of nutrition,['10.1017/S0007114520002548'] 807,32648534,Patient opinion of analgesia during external cephalic version at term in singleton pregnancy.,"To assess the opinion and the level of satisfaction of patients concerning analgesia during external cephalic version (ECV), we present the results of a survey of 120 women undergoing ECV at term during a randomised controlled trial (July 2012 to February 2013) comparing remifentanil and nitrous oxide. Overall, 110 (91.7%) women said they would repeat the procedure and 111 (92.5%) that they would recommend it to another pregnant woman, with no significant differences by type of analgesia. The administration and sense of comfort were rated better in the remifentanil group ( p  < .01). In conclusion, the use of analgesia during ECV is associated with a high rate of willingness among women to repeat the procedure and recommend it to other pregnant women.Impact statement What is already known on this subject? ECV is commonly a painful manoeuvre for the woman. This pain triggers maternal reactive abdominal muscle contraction and involuntary abdominal tensing, reducing the likelihood of successful version and causing some women to reject the technique. What do the results of this study add? The use of analgesia during ECV is associated with a high rate of willingness among women to repeat the procedure and recommend it to other pregnant women. The sense of comfort during ECV was also significantly better in the remifentanil group, probably because of its greater analgesic power and greater comfort during its administration. What are the implications of these findings for clinical practice and/or further research? ECV should be carried out under analgesia, when available, not only to decrease pain but also to encourage wider adoption of the technique and enable more women to benefit from it.",2020,The administration and sense of comfort were rated better in the remifentanil group ( p  < .01).,['120 women undergoing ECV at term during a randomised controlled trial (July 2012 to February 2013) comparing'],"['remifentanil and nitrous oxide', 'external cephalic version (ECV', 'remifentanil', 'ECV']",['pain'],"[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0410877', 'cui_str': 'External cephalic version'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0410877', 'cui_str': 'External cephalic version'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}]",120.0,0.0546024,The administration and sense of comfort were rated better in the remifentanil group ( p  < .01).,"[{'ForeName': 'Leire', 'Initials': 'L', 'LastName': 'Rodríguez', 'Affiliation': 'Obstetrics and Gynecology Department, Biocruces Bizkaia Health Research Institute, Cruces University Hospital, Bizkaia, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Osuna', 'Affiliation': 'Obstetrics and Gynecology Department, Biocruces Bizkaia Health Research Institute, Cruces University Hospital, Bizkaia, Spain.'}, {'ForeName': 'José I', 'Initials': 'JI', 'LastName': 'Pijoan', 'Affiliation': 'Clinical Epidemiology Unit, Biocruces Bizkaia Health Research Institute, Cruces University Hospital, Bizkaia, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Cobos', 'Affiliation': 'Obstetrics and Gynecology Department, Biocruces Bizkaia Health Research Institute, Cruces University Hospital, Bizkaia, Spain.'}, {'ForeName': 'María M', 'Initials': 'MM', 'LastName': 'Centeno', 'Affiliation': 'Obstetrics and Gynecology Department, Biocruces Bizkaia Health Research Institute, Cruces University Hospital, Bizkaia, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Serna', 'Affiliation': 'Anesthesia Department, Biocruces Bizkaia Health Research Institute, Cruces University Hospital, Bizkaia, Spain.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Jiménez', 'Affiliation': 'Anesthesia Department, Biocruces Bizkaia Health Research Institute, Cruces University Hospital, Bizkaia, Spain.'}, {'ForeName': 'Izaskun', 'Initials': 'I', 'LastName': 'Artola', 'Affiliation': 'Obstetrics and Gynecology Department, Biocruces Bizkaia Health Research Institute, Cruces University Hospital, Bizkaia, Spain.'}, {'ForeName': 'Iñigo', 'Initials': 'I', 'LastName': 'Melchor', 'Affiliation': 'Obstetrics and Gynecology Department, Biocruces Bizkaia Health Research Institute, Cruces University Hospital, Bizkaia, Spain.'}, {'ForeName': 'Txantón', 'Initials': 'T', 'LastName': 'Martínez-Astorquiza', 'Affiliation': 'Obstetrics and Gynecology Department, Biocruces Bizkaia Health Research Institute, Cruces University Hospital, Bizkaia, Spain.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Melchor', 'Affiliation': 'Obstetrics and Gynecology Department, Biocruces Bizkaia Health Research Institute, Cruces University Hospital, Bizkaia, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Burgos', 'Affiliation': 'Obstetrics and Gynecology Department, Biocruces Bizkaia Health Research Institute, Cruces University Hospital, Bizkaia, Spain.'}]",Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology,['10.1080/01443615.2019.1647522'] 808,32649961,The effect of platelet-rich plasma on female androgenetic alopecia: A randomized controlled trial.,"BACKGROUND Platelet-rich plasma (PRP) may be a useful treatment for androgenetic alopecia (AGA), although objective studies are needed. OBJECTIVE To determine whether PRP injections improve female AGA. METHOD Prospective randomized controlled trial of 30 women diagnosed with AGA. Patients received subdermal scalp injections of Eclipse system PRP or placebo saline at weeks 0, 4, and 8. Outcome measures were changes in hair density (hair/cm 2 ), hair caliber (mm), and blinded global photographic assessment (improved or not improved) at week 24. RESULTS Blinded global photographic assessment indicated that 57% of patients receiving PRP versus 7% of patients receiving saline improved at week 24 from baseline (P < .01). Compared to baseline, there was improvement in mean density in the PRP group versus the placebo group at week 8 (+71.1 vs -26.7 hairs/cm 2 ; P < .01) and week 24 (+105.9 vs -52.4 hairs/cm 2 ; P < .01). Compared to baseline, there was improvement in mean caliber in the PRP group versus the placebo group at week 8 (+0.0043 vs -0.0034 mm; P < .01) and week 24 (+0.0053 vs -0.0060 mm; P < .01). Adverse effects included headache, scalp tightness, swelling, redness, and postinjection bleeding. LIMITATIONS Two patients lost to follow-up. CONCLUSIONS PRP with the Eclipse system is a safe and effective intervention for female AGA.",2020,"Compared to baseline, there was improvement in mean caliber in the PRP group vs. the placebo group at week 8 (+0.0043 vs. -0.0034 mm, p<0.01) and week 24 (+0.0053 vs. -0.0060 mm, p<0.01).","['30 females diagnosed with AGA', 'female androgenetic alopecia', 'androgenetic alopecia (AGA']","['subdermal scalp injections of Eclipse system PRP or placebo saline', 'PRP injections', 'platelet-rich plasma', 'placebo']","['mean caliber', 'headache, scalp tightness, swelling, redness, and post-injection bleeding', 'mean density', 'changes in hair density (hair/cm 2 ), hair caliber (mm), and blinded global photographic assessment']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}]","[{'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",30.0,0.356908,"Compared to baseline, there was improvement in mean caliber in the PRP group vs. the placebo group at week 8 (+0.0043 vs. -0.0034 mm, p<0.01) and week 24 (+0.0053 vs. -0.0060 mm, p<0.01).","[{'ForeName': 'Danielle P', 'Initials': 'DP', 'LastName': 'Dubin', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: DPDubin121@gmail.com.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Lin', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Hayley M', 'Initials': 'HM', 'LastName': 'Leight', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Aaron S', 'Initials': 'AS', 'LastName': 'Farberg', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York; Arkansas Dermatology, Little Rock, Arkansas.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Torbeck', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Burton', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Khorasani', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.06.1021'] 809,32652987,Does a home-based interview with a chronically ill patient help medical students become more patient-centred? A randomised controlled trial.,"BACKGROUND While patient-centred care improves patient outcomes, studies have shown that medical students become less patient-centred with time, so it is crucial to devise interventions that prevent this. We sought to determine whether first-year medical students who had a structured home-based interview with a chronically ill patient became more patient-centred than those who had a sham intervention. METHODS This randomised controlled trial assigned first-year students from the University of Bern, Switzerland, to either an interview with a chronically ill patient at the patient's home or to a sham comparator. We used the PPOS-D12 questionnaire to measure students' levels of patient-centredness at baseline, and changes in these levels during their longitudinal primary care clerkship. RESULTS A total of 317 students participated. Patient-centred attitudes increased during the study. A home-based interview with a chronically ill patient had no additional effect. Being female and having been exposed to patients before medical school were associated with being more patient-centred at baseline. Students were less patient-centred than their General Practitioner teachers. CONCLUSIONS A structured, home-based interview with a chronically ill patient did not change students' patient-centred attitudes, so cannot be recommended as a way to influence those attitudes. However, patient-centred attitudes increased during the students' first year of study, possibly because of their longitudinal primary care clerkship. TRIAL REGISTRATION Clinicaltrials.gov reference: NCT03722810 , registered 29th October 2018.",2020,"CONCLUSIONS A structured, home-based interview with a chronically ill patient did not change students' patient-centred attitudes, so cannot be recommended as a way to influence those attitudes.","['317 students participated', ""year students from the University of Bern, Switzerland, to either an interview with a chronically ill patient at the patient's home or to a sham comparator"", 'first-year medical students who had a structured home-based interview with a chronically ill patient became more patient-centred than those who had a sham intervention']",[],['Patient-centred attitudes'],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0008715', 'cui_str': 'Chronically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",317.0,0.0668715,"CONCLUSIONS A structured, home-based interview with a chronically ill patient did not change students' patient-centred attitudes, so cannot be recommended as a way to influence those attitudes.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Harris', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland. michael.harris@biham.unibe.ch.'}, {'ForeName': 'Anna-Lea', 'Initials': 'AL', 'LastName': 'Camenzind', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Fankhauser', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Streit', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hari', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}]",BMC medical education,['10.1186/s12909-020-02136-y'] 810,32653895,Optimizing behavior therapy for youth with Tourette's disorder.,"Tourette's Disorder (TD) is characterized by tics that cause distress and impairment. While treatment guidelines recommend behavior therapy as a first-line intervention, patients with TD may exhibit limited therapeutic response. Given the need to improve treatment outcomes, this study examined the efficacy of augmenting behavior therapy with D-cycloserine (DCS) to reduce tic severity in a placebo-controlled quick-win/fast-fail trial. Twenty youth with TD completed a baseline assessment to characterize tic severity, premonitory urges, medical history, and psychiatric comorbidity. Youth were randomly assigned to receive a single session of habit reversal training (HRT) augmented by either 50 mg of DCS or placebo. Two bothersome tics on the Hopkins Motor/Vocal Tic Scale (HM/VTS) were targeted for treatment during HRT. One week after the HRT session, youth completed a posttreatment assessment to evaluate change in the severity of bothersome tics. All assessments were completed by independent evaluators masked to treatment group. There was a Treatment Group by Time Interaction in favor of DCS-augmented HRT (p < 0.01), controlling for baseline tic severity, tic medication, and attention deficit hyperactivity disorder. Follow-up comparisons revealed small group differences at the treatment visit (d = 0.27), with the DCS group exhibiting slightly greater severity for targeted tics. There was a large group difference at posttreatment, in which the DCS group exhibited lower severity for targeted tics (d = 1.30, p < 0.001) relative to the placebo group. Findings demonstrate the preliminary enhancement of tic severity reductions by augmenting HRT with DCS compared with placebo augmentation.",2020,"There was a Treatment Group by Time Interaction in favor of DCS-augmented HRT (p < 0.01), controlling for baseline tic severity, tic medication, and attention deficit hyperactivity disorder.","[""youth with Tourette's disorder"", 'Twenty youth with TD completed a baseline assessment to characterize tic severity, premonitory urges, medical history, and psychiatric comorbidity']","['placebo', 'habit reversal training (HRT) augmented by either 50\u2009mg of DCS or placebo', 'DCS', 'behavior therapy with D-cycloserine (DCS']","['Hopkins Motor/Vocal Tic Scale (HM/VTS', 'targeted tics', 'severity of bothersome tics']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0040517', 'cui_str': ""Gilles de la Tourette's syndrome""}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0040188', 'cui_str': 'Tic disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0751901', 'cui_str': 'Tic, Vocal'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040188', 'cui_str': 'Tic disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",20.0,0.322576,"There was a Treatment Group by Time Interaction in favor of DCS-augmented HRT (p < 0.01), controlling for baseline tic severity, tic medication, and attention deficit hyperactivity disorder.","[{'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'McGuire', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA. jfmcguire@jhmi.edu.'}, {'ForeName': 'Nathaniel', 'Initials': 'N', 'LastName': 'Ginder', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Kesley', 'Initials': 'K', 'LastName': 'Ramsey', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Joey Ka-Yee', 'Initials': 'JK', 'LastName': 'Essoe', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Ricketts', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'McCracken', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Piacentini', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0762-4'] 811,32661681,Effects of hesperidin in orange juice on blood and pulse pressures in mildly hypertensive individuals: a randomized controlled trial (Citrus study).,"PURPOSE To assess the sustained and acute effects, as well as the influence of sustained consumption on the acute effects, of orange juice (OJ) with a natural hesperidin content and hesperidin-enriched OJ (EOJ) on blood (BP) and pulse (PP) pressures in pre- and stage-1 hypertensive individuals. METHODS In a randomized, parallel, double-blind, placebo-controlled trial, participants (n = 159) received 500 mL/day of control drink, OJ, or EOJ for 12 weeks. Two dose-response studies were performed at baseline and after 12 weeks. RESULTS A single EOJ dose (500 mL) reduced systolic BP (SBP) and PP, with greater changes after sustained treatment where a decrease in diastolic BP (DBP) also occurred (P < 0.05). SBP and PP decreased in a dose-dependent manner relative to the hesperidin content of the beverages throughout the 12 weeks (P < 0.05). OJ and EOJ decreased homocysteine levels at 12 weeks versus the control drink (P < 0.05). After 12 weeks of EOJ consumption, four genes related to hypertension (PTX3, NLRP3, NPSR1 and NAMPT) were differentially expressed in peripheral blood mononuclear cells (P < 0.05). CONCLUSION Hesperidin in OJ reduces SBP and PP after sustained consumption, and after a single dose, the chronic consumption of EOJ enhances its postprandial effect. Decreases in systemic and transcriptomic biomarkers were concomitant with BP and PP changes. EOJ could be a useful co-adjuvant tool for BP and PP management in pre- and stage-1 hypertensive individuals.",2021,OJ and EOJ decreased homocysteine levels at 12 weeks versus the control drink (P < 0.05).,"['mildly hypertensive individuals', 'participants (n\u2009=\u2009159) received', 'pre- and stage-1 hypertensive individuals']","['500\xa0mL/day of control drink, OJ, or EOJ', 'EOJ', 'orange juice (OJ) with a natural hesperidin content and hesperidin-enriched OJ (EOJ', 'hesperidin', 'placebo']","['OJ and EOJ decreased homocysteine levels', 'hypertension (PTX3, NLRP3, NPSR1 and NAMPT', 'peripheral blood mononuclear cells', 'systemic and transcriptomic biomarkers', 'diastolic BP (DBP', 'reduced systolic BP (SBP) and PP', 'blood and pulse pressures', 'blood (BP) and pulse (PP) pressures', 'SBP and PP']","[{'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}]","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439446', 'cui_str': 'mL/24h'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0019392', 'cui_str': 'Hesperidin'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C2242817', 'cui_str': 'Homocysteine measurement'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C1571622', 'cui_str': 'nicotinamide phosphoribosyltransferase, human'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}]",,0.134296,OJ and EOJ decreased homocysteine levels at 12 weeks versus the control drink (P < 0.05).,"[{'ForeName': 'Rosa M', 'Initials': 'RM', 'LastName': 'Valls', 'Affiliation': 'Functional Nutrition, Oxidation, and Cardiovascular Diseases Group (NFOC-Salut), Universitat Rovira i Virgili, Facultat de Medicina i Ciències de La Salut, Reus, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Pedret', 'Affiliation': 'Functional Nutrition, Oxidation, and Cardiovascular Diseases Group (NFOC-Salut), Universitat Rovira i Virgili, Facultat de Medicina i Ciències de La Salut, Reus, Spain. anna.pedret@eurecat.org.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Calderón-Pérez', 'Affiliation': 'Functional Nutrition, Oxidation, and Cardiovascular Diseases Group (NFOC-Salut), Universitat Rovira i Virgili, Facultat de Medicina i Ciències de La Salut, Reus, Spain.'}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Llauradó', 'Affiliation': 'Functional Nutrition, Oxidation, and Cardiovascular Diseases Group (NFOC-Salut), Universitat Rovira i Virgili, Facultat de Medicina i Ciències de La Salut, Reus, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pla-Pagà', 'Affiliation': 'Functional Nutrition, Oxidation, and Cardiovascular Diseases Group (NFOC-Salut), Universitat Rovira i Virgili, Facultat de Medicina i Ciències de La Salut, Reus, Spain.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Companys', 'Affiliation': 'Functional Nutrition, Oxidation, and Cardiovascular Diseases Group (NFOC-Salut), Universitat Rovira i Virgili, Facultat de Medicina i Ciències de La Salut, Reus, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Moragas', 'Affiliation': 'Departament de Medicina i Cirurgia, Universitat Rovira i Virgili, Reus, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Martín-Luján', 'Affiliation': 'Departament de Medicina i Cirurgia, Universitat Rovira i Virgili, Reus, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Ortega', 'Affiliation': ""Institut Universitari d'Investigació en Atenció Primària-IDIAP Jordi Gol, Tarragona, Spain.""}, {'ForeName': 'Montse', 'Initials': 'M', 'LastName': 'Giralt', 'Affiliation': 'Functional Nutrition, Oxidation, and Cardiovascular Diseases Group (NFOC-Salut), Universitat Rovira i Virgili, Facultat de Medicina i Ciències de La Salut, Reus, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Romeu', 'Affiliation': 'Functional Nutrition, Oxidation, and Cardiovascular Diseases Group (NFOC-Salut), Universitat Rovira i Virgili, Facultat de Medicina i Ciències de La Salut, Reus, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Rubió', 'Affiliation': 'Functional Nutrition, Oxidation, and Cardiovascular Diseases Group (NFOC-Salut), Universitat Rovira i Virgili, Facultat de Medicina i Ciències de La Salut, Reus, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Mayneris-Perxachs', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Av. de La Universitat, 1, 43204, Reus, Spain.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Canela', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Centre for Omic Sciences, Reus, Spain.'}, {'ForeName': 'Francesc', 'Initials': 'F', 'LastName': 'Puiggrós', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Av. de La Universitat, 1, 43204, Reus, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Caimari', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Av. de La Universitat, 1, 43204, Reus, Spain.'}, {'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Del Bas', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Av. de La Universitat, 1, 43204, Reus, Spain.'}, {'ForeName': 'Lluís', 'Initials': 'L', 'LastName': 'Arola', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Av. de La Universitat, 1, 43204, Reus, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Solà', 'Affiliation': 'Functional Nutrition, Oxidation, and Cardiovascular Diseases Group (NFOC-Salut), Universitat Rovira i Virgili, Facultat de Medicina i Ciències de La Salut, Reus, Spain.'}]",European journal of nutrition,['10.1007/s00394-020-02279-0'] 812,32649851,Jin Shin Jyutsu® Self-Help Reduces Nurse Stress: A Randomized Controlled Study.,"Purpose: The purpose of this research was to explore the impact of Jin Shin Jyutsu (JSJ) Self-Help on personal stress and the caring efficacy of nurses. Design: A randomized, controlled comparison study, with crossover design was conducted. Method: Stress and caring efficacy were measured via surveys at baseline, posteducation, and again 30 to 40 days after completion of the JSJ educational intervention. Self-reported stress was the primary endpoint as measured with the validated Personal and Organizational Quality Assessment-Revised 4 Scale (POQA-R4) survey. Caring Efficacy was measured using the Coates Caring Efficacy Scale. Findings: A total of 41 nurses consented and completed the study; 18 were in the education group and 23 were in the control group. Changes in stress were sustained in the education group for the POQA-R4. Changes observed in the control group were not sustained. Statistical differences were observed when comparing education and control from baseline to final surveys for measures of emotional vitality and buoyancy. Increases in nursing caring efficacy were observed in both groups. Scores were consistently higher in the education group. Statistically significant differences were observed from baseline to final measure for the education group. Conclusions: Results show JSJ as a viable option for stress reduction in nurses.",2021,Statistical differences were observed when comparing education and control from baseline to final surveys for measures of emotional vitality and buoyancy.,['41 nurses consented and completed the study; 18 were in the education group and 23 were in the control group'],"['Jin Shin Jyutsu (JSJ', 'JSJ', 'JSJ educational intervention', 'Jin Shin Jyutsu®']","['Self-Help Reduces Nurse Stress', 'validated Personal and Organizational Quality Assessment-Revised 4 Scale (POQA-R4) survey', 'Coates Caring Efficacy Scale', 'Caring Efficacy', 'nursing caring efficacy']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0150375', 'cui_str': 'Group education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0230444', 'cui_str': 'Shin structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0029246', 'cui_str': 'Organizations'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0028678', 'cui_str': 'nursing'}]",41.0,0.0257006,Statistical differences were observed when comparing education and control from baseline to final surveys for measures of emotional vitality and buoyancy.,"[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Millspaugh', 'Affiliation': 'Atlantic Health System/Morristown Medical Center.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Errico', 'Affiliation': 'Atlantic Health System/Morristown Medical Center.'}, {'ForeName': 'Sunnie', 'Initials': 'S', 'LastName': 'Mortimer', 'Affiliation': 'Atlantic Health System/Morristown Medical Center.'}, {'ForeName': 'Mildred Ortu', 'Initials': 'MO', 'LastName': 'Kowalski', 'Affiliation': 'Atlantic Health System/Morristown Medical Center.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Chiu', 'Affiliation': 'Atlantic Health System/Morristown Medical Center.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Reifsnyder', 'Affiliation': 'Atlantic Health System/Morristown Medical Center.'}]",Journal of holistic nursing : official journal of the American Holistic Nurses' Association,['10.1177/0898010120938922'] 813,32658399,"Cerumenolytic Efficacy of 2.5% Sodium Bicarbonate Versus Docusate Sodium: A Randomized, Controlled Trial.","OBJECTIVES To evaluate the efficacy of 2.5% sodium bicarbonate and docusate sodium in patients with complete occlusion of the ear canal from impacted cerumen. STUDY DESIGN Randomized controlled trial. METHOD We enrolled patients with unilateral complete cerumen occlusion of the ear canal that was unable to be removed using suction. Either 2.5% sodium bicarbonate or docusate sodium was applied and allowed to sit for 15 minutes. The ear canal was then cleaned under a microscope for up to 3 minutes until the tympanic membrane was completely visible. A second attempt with the same agent was performed in subjects in whom the first application was unsuccessful. The outcomes were compared between the two groups in terms of cleaning, the success rate, time taken to clean the canal, and adverse events. RESULTS There were 91 participants enrolled in this study. The mean age of the participants was 48.0 years. The patients' demographic did not differ between the two groups. At the end of the treatment, the tympanic membrane was completely visible in 41 (91.11%) subjects treated with 2.5% sodium bicarbonate and 38 (82.61%) subjects treated with docusate sodium, with a 1.10 success ratio between the two groups (95% CI: 0.94-1.29, p = 0.23). The mean successful suctioning time was 103.61 seconds using 2.5% sodium bicarbonate and 124.13 using docusate sodium. The mean difference was 20.52 seconds (95% CI: -10.55-51.59). CONCLUSION 2.5% sodium bicarbonate demonstrated non-inferior efficacy and safety compared with docusate sodium. We recommend using this agent in clinical practice. TRIAL REGISTRATION Clinicaltrials.in.th/TCTR20160803001.",2020,"The outcomes were compared between the two groups in terms of cleaning, the success rate, time taken to clean the canal, and adverse events. ","['patients with complete occlusion of the ear canal from impacted cerumen', 'enrolled patients with unilateral complete cerumen occlusion of the ear canal that was unable to be removed using suction', '91 participants enrolled in this study']","['sodium bicarbonate or docusate sodium', 'sodium bicarbonate and docusate sodium', 'Sodium Bicarbonate Versus Docusate Sodium', 'sodium bicarbonate', 'docusate sodium']","['success rate, time taken to clean the canal, and adverse events', 'Cerumenolytic Efficacy', 'mean successful suctioning time', 'tympanic membrane', 'inferior efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0013444', 'cui_str': 'External auditory canal structure'}, {'cui': 'C0021092', 'cui_str': 'Impacted cerumen'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0740486', 'cui_str': 'Cerumen'}, {'cui': 'C0566415', 'cui_str': 'Unable to feed self'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0243237', 'cui_str': 'docusate sodium'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2936339', 'cui_str': 'Wax Solvent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0041445', 'cui_str': 'Tympanic membrane structure'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",91.0,0.0416517,"The outcomes were compared between the two groups in terms of cleaning, the success rate, time taken to clean the canal, and adverse events. ","[{'ForeName': 'Patorn', 'Initials': 'P', 'LastName': 'Piromchai', 'Affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine.'}, {'ForeName': 'Chanticha', 'Initials': 'C', 'LastName': 'Laohakittikul', 'Affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine.'}, {'ForeName': 'Sirichoke', 'Initials': 'S', 'LastName': 'Khunnawongkrit', 'Affiliation': 'Manufacturing Unit, Pharmacy Department, Srinagarind Hospital, Khon Kaen University, Thailand.'}, {'ForeName': 'Somchai', 'Initials': 'S', 'LastName': 'Srirompotong', 'Affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine.'}]","Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology",['10.1097/MAO.0000000000002672'] 814,32654554,Carbidopa for Afferent Baroreflex Failure in Familial Dysautonomia: A Double-Blind Randomized Crossover Clinical Trial.,"Afferent lesions of the arterial baroreflex occur in familial dysautonomia. This leads to excessive blood pressure variability with falls and frequent surges that damage the organs. These hypertensive surges are the result of excess peripheral catecholamine release and have no adequate treatment. Carbidopa is a selective DOPA-decarboxylase inhibitor that suppresses catecholamines production outside the brain. To learn whether carbidopa can inhibit catecholamine-induced hypertensive surges in patients with severe afferent baroreflex failure, we conducted a double-blind randomized crossover trial in which patients with familial dysautonomia received high dose carbidopa (600 mg/day), low-dose carbidopa (300 mg/day), or matching placebo in 3 4-week treatment periods. Among the 22 patients enrolled (13 females/8 males), the median age was 26 (range, 12-59 years). At enrollment, patients had hypertensive peaks to 164/116 (range, 144/92 to 213/150 mm Hg). Twenty-four hour urinary norepinephrine excretion, a marker of peripheral catecholamine release, was significantly suppressed on both high dose and low dose carbidopa, compared with placebo ( P =0.0075). The 2 co-primary end points of the trial were met. The SD of systolic BP variability was reduced at both carbidopa doses (low dose: 17±4; high dose: 18±5 mm Hg) compared with placebo (23±7 mm Hg; P =0.0013), and there was a significant reduction in the systolic BP peaks on active treatment ( P =0.0015). High- and low-dose carbidopa were similarly effective and well tolerated. This study provides class Ib evidence that carbidopa can reduce blood pressure variability in patients with congenital afferent baroreflex failure. Similar beneficial effects are observed in patients with acquired baroreflex lesions.",2020,"Twenty-four hour urinary norepinephrine excretion, a marker of peripheral catecholamine release, was significantly suppressed on both high dose and low dose carbidopa, compared with placebo ( P =0.0075).","['patients had hypertensive peaks to 164/116 (range, 144/92 to 213/150 mm Hg', 'patients with congenital afferent baroreflex failure', 'Familial Dysautonomia', 'familial dysautonomia', '22 patients enrolled (13 females/8 males), the median age was 26 (range, 12-59 years', 'patients with familial dysautonomia', 'patients with severe afferent baroreflex failure', 'patients with acquired baroreflex lesions']","['placebo', 'carbidopa', 'High- and low-dose carbidopa', 'Carbidopa']","['SD of systolic BP variability', 'effective and well tolerated', 'systolic BP peaks', 'blood pressure variability']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0205115', 'cui_str': 'Afferent'}, {'cui': 'C0206162', 'cui_str': 'Baroreceptor reflex'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0013364', 'cui_str': 'Familial dysautonomia'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006982', 'cui_str': 'Carbidopa'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",22.0,0.236703,"Twenty-four hour urinary norepinephrine excretion, a marker of peripheral catecholamine release, was significantly suppressed on both high dose and low dose carbidopa, compared with placebo ( P =0.0075).","[{'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Norcliffe-Kaufmann', 'Affiliation': 'From the Department of Neurology, NYU Dysautonomia Center, New York University School of Medicine.'}, {'ForeName': 'Jose-Alberto', 'Initials': 'JA', 'LastName': 'Palma', 'Affiliation': 'From the Department of Neurology, NYU Dysautonomia Center, New York University School of Medicine.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Martinez', 'Affiliation': 'From the Department of Neurology, NYU Dysautonomia Center, New York University School of Medicine.'}, {'ForeName': 'Horacio', 'Initials': 'H', 'LastName': 'Kaufmann', 'Affiliation': 'From the Department of Neurology, NYU Dysautonomia Center, New York University School of Medicine.'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.15267'] 815,32660833,The effect of astaxanthin supplementation on performance and fat oxidation during a 40 km cycling time trial.,"OBJECTIVES This study aimed to investigate whether supplementation with 12 mg⋅day -1 astaxanthin for 7 days can improve exercise performance and metabolism during a 40 km cycling time trial. DESIGN A randomised, double-blind, crossover design was employed. METHODS Twelve recreationally trained male cyclists (VO 2peak : 56.5 ± 5.5 mL⋅kg -1 ⋅min -1 , W max : 346.8  ± 38.4 W) were recruited. Prior to each experimental trial, participants were supplemented with either 12 mg⋅day -1 astaxanthin or an appearance-matched placebo for 7 days (separated by 14 days of washout). On day 7 of supplementation, participants completed a 40 km cycling time trial on a cycle ergometer, with indices of exercise metabolism measured throughout. RESULTS Time to complete the 40 km cycling time trial was improved by 1.2 ± 1.7% following astaxanthin supplementation, from 70.76 ± 3.93 min in the placebo condition to 69.90 ± 3.78 min in the astaxanthin condition (mean improvement = 51 ± 71 s, p = 0.029, g = 0.21). Whole-body fat oxidation rates were also greater (+0.09 ± 0.13 g⋅min -1 , p = 0.044, g = 0.52), and the respiratory exchange ratio lower (-0.03 ± 0.04, p = 0.024, g = 0.60) between 39-40 km in the astaxanthin condition. CONCLUSIONS Supplementation with 12 mg⋅day -1 astaxanthin for 7 days provided an ergogenic benefit to 40 km cycling time trial performance in recreationally trained male cyclists and enhanced whole-body fat oxidation rates in the final stages of this endurance-type performance event.",2021,Whole-body fat oxidation rates were also greater (+0.09 ± 0.13,"['Twelve recreationally trained male cyclists (VO 2peak : 56.5 ± 5.5 mL⋅kg -1 ⋅min -1 , W max : 346.8\u202f ± 38.4 W) were recruited', 'recreationally trained male cyclists']","['12 mg⋅day -1 astaxanthin', '12 mg⋅day -1 astaxanthin or an appearance-matched placebo', 'astaxanthin supplementation']","['respiratory exchange ratio', 'exercise performance and metabolism', 'Whole-body fat oxidation rates', 'Time to complete the 40 km cycling time trial', 'performance and fat oxidation']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]","[{'cui': 'C0052565', 'cui_str': 'astaxanthin'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",12.0,0.540191,Whole-body fat oxidation rates were also greater (+0.09 ± 0.13,"[{'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Brown', 'Affiliation': 'Department of Higher Education Sport, Loughborough College, United Kingdom. Electronic address: danny.brown@loucoll.ac.uk.'}, {'ForeName': 'Ashley R', 'Initials': 'AR', 'LastName': 'Warner', 'Affiliation': 'Department of Sport, Health and Exercise Science, University of Hull, United Kingdom.'}, {'ForeName': 'Sanjoy K', 'Initials': 'SK', 'LastName': 'Deb', 'Affiliation': 'School of Life Sciences, University of Westminster, United Kingdom.'}, {'ForeName': 'Lewis A', 'Initials': 'LA', 'LastName': 'Gough', 'Affiliation': 'School of Health Sciences, Birmingham City University, United Kingdom.'}, {'ForeName': 'S Andy', 'Initials': 'SA', 'LastName': 'Sparks', 'Affiliation': 'Sport Nutrition and Performance Research Group, Department of Sport and Physical Activity, Edge Hill University, United Kingdom.'}, {'ForeName': 'Lars R', 'Initials': 'LR', 'LastName': 'McNaughton', 'Affiliation': 'Sport Nutrition and Performance Research Group, Department of Sport and Physical Activity, Edge Hill University, United Kingdom; Department of Sport and Movement Studies, University of Johannesburg, South Africa.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.06.017'] 816,32662323,A randomized controlled trial of a smartphone-based application for the treatment of anxiety.,"Abstract Introduction: Generalized anxiety disorder (GAD) is prevalent among college students. Smartphone-based interventions may be a low-cost treatment method. Method: College students with self-reported GAD were randomized to receive smartphone-based guided self-help ( n  = 50), or no treatment ( n  = 50). Post-treatment and six-month follow-up outcomes included the Depression Anxiety Stress Scales-Short Form Stress Subscale (DASS Stress), the Penn State Worry Questionnaire (PSWQ-11), and the State-Trait Anxiety Inventory-Trait (STAI-T), as well as diagnostic status assessed by the GAD-Questionnaire, 4th edition. Results: From pre- to post-treatment, participants who received guided self-help (vs. no treatment) experienced significantly greater reductions on the DASS Stress ( d  = -0.408) and a greater probability of remission from GAD ( d  = -0.445). There was no significant between-group difference in change on the PSWQ-11 ( d  = -0.208) or STAI-T ( d  = -0.114). From post to six-month follow-up there was no significant loss of gains on DASS Stress scores ( d  = -0.141) and of those who had remitted, 78.6% remained remitted. Yet rates of remitted participants no longer differed significantly between conditions at follow-up ( d  = -0.229). Conclusion: Smartphone-based interventions may be efficacious in treating some aspects of GAD. Methods for improving symptom reduction and long-term outcome are discussed.",2021,"From post to six-month follow-up there was no significant loss of gains on DASS Stress scores ( d  = -0.141) and of those who had remitted, 78.6% remained remitted.","['college students', 'Method: College students with self-reported GAD']","['Smartphone-based interventions', 'smartphone-based guided self-help ( n \u2009=\u200950), or no treatment', 'smartphone-based application']","['probability of remission from GAD', 'DASS Stress scores', 'PSWQ-11', 'Depression Anxiety Stress Scales-Short Form Stress Subscale (DASS Stress), the Penn State Worry Questionnaire (PSWQ-11), and the State-Trait Anxiety Inventory-Trait (STAI-T), as well as diagnostic status assessed by the GAD-Questionnaire, 4th edition', 'DASS Stress']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C2959752', 'cui_str': 'Penn State worry questionnaire'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}]",,0.0274946,"From post to six-month follow-up there was no significant loss of gains on DASS Stress scores ( d  = -0.141) and of those who had remitted, 78.6% remained remitted.","[{'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Newman', 'Affiliation': 'Department of Psychology, the Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Jacobson', 'Affiliation': 'Department of Psychology, the Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Gavin N', 'Initials': 'GN', 'LastName': 'Rackoff', 'Affiliation': 'Department of Psychology, the Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Megan Jones', 'Initials': 'MJ', 'LastName': 'Bell', 'Affiliation': 'Headspace, Inc., San Francisco, CA, USA.'}, {'ForeName': 'C Barr', 'Initials': 'CB', 'LastName': 'Taylor', 'Affiliation': 'Department of Psychiatry, Stanford University, Stanford, CA, USA.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2020.1790688'] 817,32666240,Locking compression plate fixation versus intramedullary nailing of humeral shaft fractures: which one is better? A single-centre prospective randomized study.,"PURPOSE To compare the radiological and clinical outcomes of interlocking nail (ILN) and locking plate fixation (LCP) for humeral shaft fractures. METHODS A total of 63 patients with displaced humeral shaft fractures between October 2014 and January 2017 were evaluated prospectively. They were divided randomly into two as LCP fixation (group 1) and interlocking nail (ILN) (group 2). Functional outcomes were evaluated using the Disabilities of the Arm, Shoulder, and Hand (DASH), American Shoulder and Elbow Surgeons (ASES), the University of California at Los Angeles (UCLA) shoulder scores, and Short Form-36 (SF-36) questionnaires, and pain was assessed with visual analogue scale (VAS). RESULTS After fracture callus was radiologically observed, DASH, ASES, and UCLA scores as well as SF-36 questionnaires and VAS results were noted to have no significant difference between the two groups (p = 0.109, p = 0.082, p = 0.146, p = 0.322, and p = 0.175, respectively). At the last follow-up (post-operative 24 months), the UCLA score was significantly better in group 1 (p = 0.034), whereas VAS result was significantly worse in group 2 (p = 0.017). DASH, ASES scores, and SF-36 questionnaires had no difference (p = 0.193, p = 0.088, p = 0.289). Other parameters revealed no significant differences. Fracture consolidation was observed at a mean of four months in both groups (3 to 7 months in group 1 and 3 to 8 months in group 2) (p = 0.189). Four patients in group 1 and five patients in group 2 underwent surgery for nonunion (p = 0.725). Post-operative radial nerve palsy was seen in one patient in group 2. Two patients in group 1 with superficial infection were treated with antibiotics, and they recovered. CONCLUSIONS Regarding our results, the LCP group had significantly better shoulder function than the ILN group, whereas the ILN group had significantly less pain, with similar complication rates. Therefore, both procedures are favourable surgical options for patients with humeral shaft fractures.",2020,Fracture consolidation was observed at a mean of four months in both groups (3 to 7 months in group 1 and 3 to 8 months in group 2) (p = 0.189).,"['humeral shaft fractures', 'patients with humeral shaft fractures', '63 patients with displaced humeral shaft fractures between October 2014 and January 2017 were evaluated prospectively']","['LCP fixation', 'LCP', 'interlocking nail (ILN) and locking plate fixation (LCP', 'interlocking nail (ILN', 'Locking compression plate fixation versus intramedullary nailing']","['VAS result', 'UCLA score', 'shoulder function', 'Disabilities of the Arm, Shoulder, and Hand (DASH), American Shoulder and Elbow Surgeons (ASES), the University of California at Los Angeles (UCLA) shoulder scores, and Short Form-36 (SF-36) questionnaires, and pain was assessed with visual analogue scale (VAS', 'DASH, ASES scores, and SF-36 questionnaires', 'DASH, ASES, and UCLA scores', 'Fracture consolidation', 'pain', 'SF-36 questionnaires and VAS results']","[{'cui': 'C0588210', 'cui_str': 'Bone structure of shaft of humerus'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}]","[{'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}]",63.0,0.0209717,Fracture consolidation was observed at a mean of four months in both groups (3 to 7 months in group 1 and 3 to 8 months in group 2) (p = 0.189).,"[{'ForeName': 'Yavuz', 'Initials': 'Y', 'LastName': 'Akalın', 'Affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital, Department of Orthopaedics and Traumatology, University of Health Sciences, 16310, Yıldırım, Bursa, Turkey. dryakalin@yahoo.com.'}, {'ForeName': 'İsmail Gökhan', 'Initials': 'İG', 'LastName': 'Şahin', 'Affiliation': 'Turkish Ministry of Health, Edirne Sultan 1. Murat Devlet Hastanesi, Department of Orthopaedics and Traumatology, 22100, Edirne, Turkey.'}, {'ForeName': 'Nazan', 'Initials': 'N', 'LastName': 'Çevik', 'Affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital, Department of Orthopaedics and Traumatology, University of Health Sciences, 16310, Yıldırım, Bursa, Turkey.'}, {'ForeName': 'Burak Olcay', 'Initials': 'BO', 'LastName': 'Güler', 'Affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital, Department of Orthopaedics and Traumatology, University of Health Sciences, 16310, Yıldırım, Bursa, Turkey.'}, {'ForeName': 'Özgür', 'Initials': 'Ö', 'LastName': 'Avci', 'Affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital, Department of Orthopaedics and Traumatology, University of Health Sciences, 16310, Yıldırım, Bursa, Turkey.'}, {'ForeName': 'Alpaslan', 'Initials': 'A', 'LastName': 'Öztürk', 'Affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital, Department of Orthopaedics and Traumatology, University of Health Sciences, 16310, Yıldırım, Bursa, Turkey.'}]",International orthopaedics,['10.1007/s00264-020-04696-6'] 818,32662833,"Which Chronic Low Back Pain Patients Respond Favorably to Yoga, Physical Therapy, and a Self-care Book? Responder Analyses from a Randomized Controlled Trial.","PURPOSE To identify baseline characteristics of adults with chronic low back pain (cLBP) that predict response (i.e., a clinically important improvement) and/or modify treatment effect across three nonpharmacologic interventions. DESIGN Secondary analysis of a randomized controlled trial. SETTING Academic safety net hospital and seven federally qualified community health centers. SUBJECTS Adults with cLBP (N = 299). METHODS We report patient characteristics that were predictors of response and/or modified treatment effect across three 12-week treatments: yoga, physical therapy [PT], and a self-care book. Using preselected characteristics, we used logistic regression to identify predictors of ""response,"" defined as a ≥30% improvement in the Roland Morris Disability Questionnaire. Then, using ""response"" as our outcome, we identified baseline characteristics that were treatment effect modifiers by testing for statistical interaction (P < 0.05) across two comparisons: 1) yoga-or-PT vs self-care and 2) yoga vs PT. RESULTS Overall, 39% (116/299) of participants were responders, with more responders in the yoga-or-PT group (42%) than the self-care (23%) group. There was no difference in proportion responding to yoga (48%) vs PT (37%, odds ratio [OR] = 1.5, 95% confidence interval = 0.88 - 2.6). Predictors of response included having more than a high school education, a higher income, employment, few depressive symptoms, lower perceived stress, few work-related fear avoidance beliefs, high pain self-efficacy, and being a nonsmoker. Effect modifiers included use of pain medication and fear avoidance beliefs related to physical activity (both P = 0.02 for interaction). When comparing yoga or PT with self-care, a greater proportion were responders among those using pain meds (OR = 5.3), which differed from those not taking pain meds (OR = 0.94) at baseline. We also found greater treatment response among those with lower (OR = 7.0), but not high (OR = 1.3), fear avoidance beliefs around physical activity. CONCLUSIONS Our findings revealed important subgroups for whom referral to yoga or PT may improve cLBP outcomes.",2021,Effect modifiers included use of pain medication and fear avoidance beliefs related to physical activity (both P = 0.02 for interaction).,"['Adults with cLBP (N\u2009=\u2009299', 'adults with chronic low back pain (cLBP', 'Academic safety net hospital and seven federally qualified community health centers']","['yoga-or-PT vs self-care and 2) yoga vs PT', 'yoga, physical therapy [PT']","['pain medication and fear avoidance beliefs related to physical activity', 'cLBP outcomes', 'proportion responding to yoga']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C3661443', 'cui_str': 'Safety-net Hospitals'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}]",,0.10913,Effect modifiers included use of pain medication and fear avoidance beliefs related to physical activity (both P = 0.02 for interaction).,"[{'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Roseen', 'Affiliation': 'Department of Family Medicine, Boston University School of Medicine and Boston Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Gerlovin', 'Affiliation': 'Slone Epidemiology Center, Boston University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Felson', 'Affiliation': 'Clinical Epidemiology Research and Training Unit, Boston University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Delitto', 'Affiliation': 'School of Health and Rehabilitation Sciences, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Sherman', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, Washington, USA.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Saper', 'Affiliation': 'Department of Family Medicine, Boston University School of Medicine and Boston Medical Center, Boston, Massachusetts, USA.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa153'] 819,32665218,"Robotic versus laparoscopic ventral hernia repair: multicenter, blinded randomized controlled trial.","OBJECTIVE To determine whether robotic ventral hernia repair is associated with fewer days in the hospital 90 days after surgery compared with laparoscopic repair. DESIGN Pragmatic, blinded randomized controlled trial. SETTING Multidisciplinary hernia clinics in Houston, USA. PARTICIPANTS 124 patients, deemed appropriate candidates for elective minimally invasive ventral hernia repair, consecutively presenting from April 2018 to February 2019. INTERVENTIONS Robotic ventral hernia repair (n=65) versus laparoscopic ventral hernia repair (n=59). MAIN OUTCOME MEASURES The primary outcome was number of days in hospital within 90 days after surgery. Secondary outcomes included emergency department visits, operating room time, wound complications, hernia recurrence, reoperation, abdominal wall quality of life, and costs from the healthcare system perspective. Outcomes were pre-specified before data collection began and analyzed as intention to treat. RESULTS Patients from both groups were similar at baseline. Ninety day follow-up was completed in 123 (99%) patients. No evidence was seen of a difference in days in hospital between the two groups (median 0 v 0 days; relative rate 0.90, 95% confidence interval 0.37 to 2.19; P=0.82). For secondary outcomes, no differences were noted in emergency department visits, wound complications, hernia recurrence, or reoperation. However, robotic repair had longer operative duration (141 v 77 min; mean difference 62.89, 45.75 to 80.01; P≤0.001) and increased healthcare costs ($15 865 (£12 746; €14 125) v $12 955; cost ratio 1.21, 1.07 to 1.38; adjusted absolute cost difference $2767, $910 to $4626; P=0.004). Among patients with robotic ventral hernia repair, two had an enterotomy compared none with laparoscopic repair. The median one month postoperative improvement in abdominal wall quality of life was 3 with robotic ventral hernia repair compared with 15 following laparoscopic repair. CONCLUSION This study found no evidence of a difference in 90 day postoperative hospital days between robotic and laparoscopic ventral hernia repair. However, robotic repair increased operative duration and healthcare costs. TRIAL REGISTRATION Clinicaltrials.gov NCT03490266.",2020,"However, robotic repair had longer operative duration (141 v 77 min; mean difference 62.89, 45.75 to 80.01; P≤0.001) and increased healthcare costs ($15 865 (£12 746; €14 125) v $12 955; cost ratio 1.21, 1.07 to 1.38; adjusted absolute cost difference $2767, $910 to $4626; P=0.004).","['patients with robotic ventral hernia repair, two had an enterotomy compared none with laparoscopic repair', '124 patients, deemed appropriate candidates for elective minimally invasive ventral hernia repair, consecutively presenting from April 2018 to February 2019', 'Multidisciplinary hernia clinics in Houston, USA', 'n=59']","['laparoscopic ventral hernia repair', 'Robotic versus laparoscopic ventral hernia repair', 'robotic ventral hernia repair', 'Robotic ventral hernia repair', 'laparoscopic repair', 'robotic and laparoscopic ventral hernia repair']","['abdominal wall quality of life', 'healthcare costs', 'emergency department visits, operating room time, wound complications, hernia recurrence, reoperation, abdominal wall quality of life, and costs from the healthcare system perspective', 'operative duration and healthcare costs', 'operative duration', 'number of days in hospital within 90 days after surgery', 'emergency department visits, wound complications, hernia recurrence, or reoperation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0019334', 'cui_str': 'Repair of ventral hernia'}, {'cui': 'C0192579', 'cui_str': 'Incision of intestine'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0019334', 'cui_str': 'Repair of ventral hernia'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0836916', 'cui_str': 'Abdominal wall structure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",,0.631683,"However, robotic repair had longer operative duration (141 v 77 min; mean difference 62.89, 45.75 to 80.01; P≤0.001) and increased healthcare costs ($15 865 (£12 746; €14 125) v $12 955; cost ratio 1.21, 1.07 to 1.38; adjusted absolute cost difference $2767, $910 to $4626; P=0.004).","[{'ForeName': 'Oscar A', 'Initials': 'OA', 'LastName': 'Olavarria', 'Affiliation': 'Department of Surgery, Lyndon B. Johnson General Hospital, McGovern Medical School at UTHealth, Houston, TX 77026, USA oscarolavarria@hotmail.com.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Bernardi', 'Affiliation': 'Department of Surgery, Lyndon B. Johnson General Hospital, McGovern Medical School at UTHealth, Houston, TX 77026, USA.'}, {'ForeName': 'Shinil K', 'Initials': 'SK', 'LastName': 'Shah', 'Affiliation': 'Department of Surgery, Lyndon B. Johnson General Hospital, McGovern Medical School at UTHealth, Houston, TX 77026, USA.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Wilson', 'Affiliation': 'Department of Surgery, Lyndon B. Johnson General Hospital, McGovern Medical School at UTHealth, Houston, TX 77026, USA.'}, {'ForeName': 'Shuyan', 'Initials': 'S', 'LastName': 'Wei', 'Affiliation': 'Department of Surgery, Lyndon B. Johnson General Hospital, McGovern Medical School at UTHealth, Houston, TX 77026, USA.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pedroza', 'Affiliation': 'Department of Pediatrics, McGovern Medical School at UTHealth, Houston, TX, USA.'}, {'ForeName': 'Elenir B', 'Initials': 'EB', 'LastName': 'Avritscher', 'Affiliation': 'Department of Pediatrics, McGovern Medical School at UTHealth, Houston, TX, USA.'}, {'ForeName': 'Michele M', 'Initials': 'MM', 'LastName': 'Loor', 'Affiliation': 'Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Tien C', 'Initials': 'TC', 'LastName': 'Ko', 'Affiliation': 'Department of Surgery, Lyndon B. Johnson General Hospital, McGovern Medical School at UTHealth, Houston, TX 77026, USA.'}, {'ForeName': 'Lillian S', 'Initials': 'LS', 'LastName': 'Kao', 'Affiliation': 'Department of Surgery, Lyndon B. Johnson General Hospital, McGovern Medical School at UTHealth, Houston, TX 77026, USA.'}, {'ForeName': 'Mike K', 'Initials': 'MK', 'LastName': 'Liang', 'Affiliation': 'Department of Surgery, Lyndon B. Johnson General Hospital, McGovern Medical School at UTHealth, Houston, TX 77026, USA.'}]",BMJ (Clinical research ed.),['10.1136/bmj.m2457'] 820,32664282,"Changes in Metabolites During an Oral Glucose Tolerance Test in Early and Mid-Pregnancy: Findings from the PEARLS Randomized, Controlled Lifestyle Trial.","The oral glucose tolerance test (OGTT) is used to diagnose gestational and other types of diabetes. We examined metabolite changes during an OGTT, and how a comprehensive diet and physical activity intervention may influence these changes in a population of overweight/obese Hispanic pregnant women. Integration of changes in metabolites during an OGTT may help us gain preliminary insights into how glucose metabolism changes during pregnancy. Among women from the Pregnancy and EARly Lifestyle improvement Study (PEARLS), we measured metabolites during a multipoint OGTT (fasting, 30, 60 and 120 min) at early and mid-pregnancy. Metabolite levels were measured by liquid chromatography-mass spectrometry in plasma samples in the lifestyle intervention ( n = 13) and control ( n = 16) arms of the study. A total of 65 candidate metabolites were selected that displayed changes during an OGTT in previous studies. Paired and unpaired t -tests were used to examine differences in Δfast-120 min: (1) at early and mid-pregnancy; and (2) by intervention assignment. We applied principal component analysis (PCA) to identify those metabolites that differed by intervention assignment and OGTT time points. Most of the characteristic changes in metabolites post-OGTT were similar at both gestational time points. PCA identified characteristic metabolite patterns associated with OGTT time points at both early and mid-pregnancy. These metabolites included ketone bodies, tryptophan, acyl carnitines, polyunsaturated fatty acids, and biomarkers related to bile acid, urea cycle, arginine, and proline metabolism. PCA identified distinct Δfast-120 min in fatty acid, acyl carnitine, bile acid, ketone body, and amino acid levels at mid- compared to early pregnancy. Participants in the intervention group did not display mean decreases in Δfast-120 min of several long-chain acyl carnitines that were observed in the control group. These findings provide preliminary insight into metabolites, whose role in increased insulin resistance during pregnancy, should be explored further in future studies.",2020,Participants in the intervention group did not display mean decreases in Δfast-120 min of several long-chain acyl carnitines that were observed in the control group.,"['population of overweight/obese Hispanic pregnant women', 'Early and Mid-Pregnancy']",['comprehensive diet and physical activity intervention'],"['Metabolite levels', 'fatty acid, acyl carnitine, bile acid, ketone body, and amino acid levels', 'oral glucose tolerance test (OGTT']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0368608', 'cui_str': 'Acylcarnitine'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C0022631', 'cui_str': 'Ketone body'}, {'cui': 'C1328436', 'cui_str': 'Amino acid level'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]",,0.0276949,Participants in the intervention group did not display mean decreases in Δfast-120 min of several long-chain acyl carnitines that were observed in the control group.,"[{'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'Haslam', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, 655 Huntington Ave, Boston, MA 02115, USA.'}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Liang', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, 655 Huntington Ave, Boston, MA 02115, USA.'}, {'ForeName': 'Marijulie', 'Initials': 'M', 'LastName': 'Martinez', 'Affiliation': 'Center for Clinical Research and Health Promotion, University of Puerto Rico Medical Sciences Campus, San Juan, PR 00936-5067, Puerto Rico.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Palacios', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, 11200 SW 8th Street AHC5, Miami, FL 33199, USA.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Trak-Fellermeier', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, 11200 SW 8th Street AHC5, Miami, FL 33199, USA.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Franks', 'Affiliation': 'Lund University Diabetes Centre, CRC, SUS Malmö, Jan Waldenströms gata 35, House 91:12, SE-214 28 Malmö, Sweden.'}, {'ForeName': 'Kaumudi', 'Initials': 'K', 'LastName': 'Joshipura', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, 655 Huntington Ave, Boston, MA 02115, USA.'}, {'ForeName': 'Shilpa N', 'Initials': 'SN', 'LastName': 'Bhupathiraju', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA.""}]",Metabolites,['10.3390/metabo10070284'] 821,32654802,Atezolizumab plus Bevacizumab Versus Sunitinib for Patients with Untreated Metastatic Renal Cell Carcinoma and Sarcomatoid Features: A Prespecified Subgroup Analysis of the IMmotion151 Clinical Trial.,"Patients with metastatic renal cell carcinoma with sarcomatoid features (sRCC) have a poor prognosis and have shown limited responsiveness to inhibition of the VEGF pathway. We conducted a prespecified analysis of the randomised, phase 3 IMmotion151 trial in previously untreated patients with advanced or metastatic RCC to assess the effectiveness of atezolizumab + bevacizumab versus sunitinib in a subgroup of patients with sarcomatoid features. Patients whose tumour had any component of sarcomatoid features were included and received atezolizumab + bevacizumab (n = 68) or sunitinib (n = 74). Baseline characteristics were similar between the groups. Median progression-free survival was significantly longer in the group receiving atezolizumab + bevacizumab overall (8.3 vs 5.3 mo; hazard ratio [HR] 0.52 95% confidence interval [CI] 0.34-0.79) and in the subset of patients with PD-L1-positive tumours (8.6 vs 5.6 mo; HR 0.45, 95% CI 0.26-0.77). More patients receiving atezolizumab + bevacizumab achieved an objective response (49% vs 14%), including complete responses (10% vs 3%), and reported greater symptom improvements versus sunitinib. Safety was consistent with the known profiles of each drug and with that reported in the overall safety-evaluable population of IMmotion151. This analysis supports enhanced activity of atezolizumab + bevacizumab in patients with sRCC. PATIENT SUMMARY: In this report, we looked at patients with a specific type of kidney cancer (tumours with sarcomatoid features) that has been hard to treat. A treatment with two drugs (atezolizumab and bevacizumab) appeared to help patients live longer without the disease getting worse than another drug (sunitinib) that is often used. Patients who took the two drugs also said they were better able to carry out their everyday activities than patients who took sunitinib. The combination of these two drugs may work better in patients with this type of advanced kidney cancer.",2021,"More patients receiving atezolizumab + bevacizumab achieved an objective response (49% vs 14%), including complete responses (10% vs 3%), and reported greater symptom improvements versus sunitinib.","['patients with a specific type of kidney cancer (tumours with sarcomatoid features', 'patients with sRCC', 'Patients with Untreated Metastatic Renal Cell Carcinoma and Sarcomatoid Features', 'in a subgroup of patients with sarcomatoid features', 'Patients with metastatic renal cell carcinoma with sarcomatoid features (sRCC', 'previously untreated patients with advanced or metastatic RCC', 'patients with this type of advanced kidney cancer', 'Patients whose tumour had any component of sarcomatoid features']","['sunitinib', 'two drugs (atezolizumab and bevacizumab', 'Atezolizumab plus Bevacizumab Versus Sunitinib', 'atezolizumab\u2009+\u2009bevacizumab versus sunitinib', 'atezolizumab\u2009+\u2009bevacizumab']","['objective response', 'complete responses', 'everyday activities', 'Median progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0740457', 'cui_str': 'Malignant tumor of kidney'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C4721698', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.23841,"More patients receiving atezolizumab + bevacizumab achieved an objective response (49% vs 14%), including complete responses (10% vs 3%), and reported greater symptom improvements versus sunitinib.","[{'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA. Electronic address: brian.rini@vumc.org.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Barts Cancer Institute and the Royal Free Hospital, Queen Mary University of London, London, UK.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'McDermott', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Escudier', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Frede', 'Initials': 'F', 'LastName': 'Donskov', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hawkins', 'Affiliation': 'The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Bracarda', 'Affiliation': 'Azienda Ospedaliera S. Maria, Terni, Italy.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Bedke', 'Affiliation': 'University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'De Giorgi', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, IRCCS, Meldola, Italy.'}, {'ForeName': 'Camillo', 'Initials': 'C', 'LastName': 'Porta', 'Affiliation': 'IRCCS San Matteo University Hospital Foundation, Pavia, Italy.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Ravaud', 'Affiliation': 'CHU Hopitaux de Bordeaux - Hôpital Saint-André, Bordeaux, France.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Parnis', 'Affiliation': 'Ashford Cancer Centre Research, Kurralta Park, SA, Australia.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Grande', 'Affiliation': 'MD Anderson Cancer Center Madrid, Madrid, Spain.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Mahrukh', 'Initials': 'M', 'LastName': 'Huseni', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Susheela', 'Initials': 'S', 'LastName': 'Carroll', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Sufan', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Schiff', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Atkins', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Washington, DC, USA.'}]",European urology,['10.1016/j.eururo.2020.06.021'] 822,32661106,Hyperglycemia But Not Hyperinsulinemia Is Favorable for Exercise in Type 1 Diabetes: A Pilot Study.,"OBJECTIVE To distinguish the effects of hyperglycemia and hyperinsulinemia on exercise-induced increases in R d and endogenous glucose production (EGP) in type 1 diabetes. RESEARCH DESIGN AND METHODS We studied six participants without diabetes and six participants with type 1 diabetes on three visits in random order for the following: euglycemia, low insulin (EuLoI); euglycemia, high insulin (EuHiI); and hyperglycemia, low insulin (HyLoI). Glucose fluxes were measured using [6,6- 2 H 2 ] glucose before, during, and after 60 min of exercise. RESULTS R d increased ( P < 0.01) with exercise within groups, while peak R d during exercise was lower ( P < 0.01) in participants with type 1 diabetes than participants without diabetes during all visits. In type 1 diabetes participants, EGP increased ( P < 0.001) with exercise during EuLoI and HyLoI but not during EuHiI. This demonstrates that hyperinsulinemia, but not hyperglycemia, blunts the compensatory exercise-induced increase in EGP in type 1 diabetes. CONCLUSIONS The data from this pilot study indicate that 1 ) exercise-induced compensatory increase in EGP was inhibited in participants with type 1 diabetes with hyperinsulinemia but not with hyperglycemia; 2 ) in contrast, in participants without diabetes, exercise-induced increase in EGP was inhibited only during combined hyperinsulinemia and hyperglycemia. Taken together, these results suggest that low insulin coupled with euglycemia or modest hyperglycemia appear to be the most favorable milieu for type 1 diabetes during exercise.",2020,"In type 1 diabetes participants, EGP increased ( P < 0.001) with exercise during EuLoI and HyLoI but not during EuHiI.","['type 1 diabetes', 'participants with type 1 diabetes with hyperinsulinemia but not with hyperglycemia; 2 ', 'We studied six participants without diabetes and six participants with type 1 diabetes on three visits in random order for the following: euglycemia, low insulin (EuLoI); euglycemia, high insulin (EuHiI); and hyperglycemia, low insulin (HyLoI']",[],"['R d and endogenous glucose production (EGP', 'compensatory increase in EGP', 'Hyperglycemia', 'Glucose fluxes', 'EGP']","[{'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0205452', 'cui_str': '6'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0861023', 'cui_str': 'Insulin low'}]",[],"[{'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0903677', 'cui_str': 'TACSTD1 protein, human'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",6.0,0.031498,"In type 1 diabetes participants, EGP increased ( P < 0.001) with exercise during EuLoI and HyLoI but not during EuHiI.","[{'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Romeres', 'Affiliation': 'Department of Information Engineering, University of Padova, Padova, Italy.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Olson', 'Affiliation': 'Division of Endocrinology, Center of Diabetes Technology, University of Virginia School of Medicine, Charlottesville, VA.'}, {'ForeName': 'Rickey', 'Initials': 'R', 'LastName': 'Carter', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Cobelli', 'Affiliation': 'Department of Information Engineering, University of Padova, Padova, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Dalla Man', 'Affiliation': 'Department of Information Engineering, University of Padova, Padova, Italy.'}, {'ForeName': 'Ananda', 'Initials': 'A', 'LastName': 'Basu', 'Affiliation': 'Division of Endocrinology, Center of Diabetes Technology, University of Virginia School of Medicine, Charlottesville, VA basu.rita@virginia.edu.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Basu', 'Affiliation': 'Division of Endocrinology, Center of Diabetes Technology, University of Virginia School of Medicine, Charlottesville, VA basu.rita@virginia.edu.'}]",Diabetes care,['10.2337/dc20-0611'] 823,32661108,Effect of Afrezza on Glucose Dynamics During HCL Treatment.,"OBJECTIVE A major obstacle in optimizing the performance of closed-loop automated insulin delivery systems has been the delay in insulin absorption and action that results from the subcutaneous (SC) route of insulin delivery leading to exaggerated postmeal hyperglycemic excursions. We aimed to investigate the effect of Afrezza inhaled insulin with ultrafast-in and -out action profile on improving postprandial blood glucose control during hybrid closed-loop (HCL) treatment in young adults with type 1 diabetes. RESEARCH DESIGN AND METHODS We conducted an inpatient, three-way, randomized crossover standardized meal study to assess the efficacy and safety of Afrezza at a low (A L ) and a high (A H ) dose as compared with a standard SC rapid-acting insulin (aspart) premeal bolus during Diabetes Assistant (DiAs) HCL treatment. Participants received two sequential meals on three study days, and premeal insulin bolus was determined based on home insulin-to-carbohydrate ratio for each meal (rounded up to the closest available Afrezza cartridge dose for A H and down for A L ). The primary efficacy outcome was the peak postprandial plasma glucose (PPG) level calculated by pooling data for up to 4 h after the start of each meal. Secondary outcomes included hyperglycemic, hypoglycemic, and euglycemic venous glucose metrics. RESULTS The mean ± SD PPG for the rapid-acting insulin control arm and A H was similar (185 ± 50 mg/dL vs. 195 ± 46 mg/dL, respectively; P = 0.45), while it was higher for meals using A L (208 ± 54 mg/dL, P = 0.04). The A H achieved significantly lower early PPG level than the control arm (30 min; P < 0.001), and improvement in PPG waned at later time points (120 and 180 min; P = 0.02) coinciding with the end of Afrezza glucodynamic action. CONCLUSIONS Afrezza (A H ) premeal bolus reduced the early glycemic excursion and improved PPG during HCL compared with aspart premeal bolus. The improvement in PPG was not sustained after the end of Afrezza glucodynamic action at 120 min.",2020,"The A H achieved significantly lower early PPG level than the control arm (30 min; P < 0.001), and improvement in PPG waned at later time points (120 and 180 min; P = 0.02) coinciding with the end of Afrezza glucodynamic action. ",['young adults with type 1 diabetes'],"['Afrezza', 'hybrid closed-loop (HCL', 'Afrezza inhaled insulin with ultrafast-in and -out action profile', 'standard SC rapid-acting insulin (aspart) premeal bolus during Diabetes Assistant (DiAs) HCL treatment', 'premeal insulin bolus was determined based on home insulin-to-carbohydrate ratio for each meal (rounded up to the closest available Afrezza cartridge dose for A H and down for A L ']","['early PPG level', 'PPG', 'postprandial blood glucose control', 'mean ± SD PPG', 'efficacy and safety', 'early glycemic excursion and improved PPG', 'hyperglycemic, hypoglycemic, and euglycemic venous glucose metrics', 'peak postprandial plasma glucose (PPG) level']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C3834216', 'cui_str': 'Afrezza'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0023443', 'cui_str': 'Hairy cell leukemia'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0179630', 'cui_str': 'Cartridge'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0049716', 'cui_str': ""6-thioguanosine 5'-diphosphate""}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}]",,0.101007,"The A H achieved significantly lower early PPG level than the control arm (30 min; P < 0.001), and improvement in PPG waned at later time points (120 and 180 min; P = 0.02) coinciding with the end of Afrezza glucodynamic action. ","[{'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Galderisi', 'Affiliation': 'Department of Pediatrics, Yale School of Medicine, New Haven, CT alfonso.galderisi@yale.edu alfonso.galderisi@unipd.it.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Cohen', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Calhoun', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Kraemer', 'Affiliation': 'Department of Pediatrics, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Breton', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Weinzimer', 'Affiliation': 'Department of Pediatrics, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Eda', 'Initials': 'E', 'LastName': 'Cengiz', 'Affiliation': 'Department of Pediatrics, Yale School of Medicine, New Haven, CT.'}]",Diabetes care,['10.2337/dc20-0091'] 824,32667858,A Specific Mobile Health Application for Older HIV-Infected Patients: Usability and Patient's Satisfaction.,"Background: HIV infection is an increasingly complex chronic disease associated with numerous medical, psychological, and social problems. The life expectancy of affected patients has increased considerably. Medical apps could also play a role in prevention and management of comorbid conditions in the HIV-infected population. Objectives: To determine the usefulness of an app designed specifically for HIV-infected patients aged 60 years or older and to assess changes in patient satisfaction, adherence to treatment, and quality of health care. Methods: A randomized clinical trial was conducted, including 100 patients (50 per group): (1) an experimental group comprising patients using the app + routine medical care (app group) and (2) with routine medical care (control group). The usability of the app and patient satisfaction were evaluated in the app group at week 48. Quality of life, adherence to treatment, and clinical parameters were compared between both groups at 48 weeks, as well as the number of face-to-face visits. Results: We found that 52.2% and 73.8% of patients in the app group used the app at weeks 24 and 48, respectively. Patients used the app for a mean of 23.7 (±2.84) days over the 48 weeks. The most visited screens were health counseling and medical records (24.8% and 22.2%, respectively). At week 48, 85.2% of patients thought that the app was useful and 91.4% would recommend the app to friends or relatives. The app was well valued by participants (4.79 [±0.21] of 5.00) and 64.6% thought that the app improved their health care.",2021,The app was well valued by participants (4.79 [±0.21] of 5.00) and 64.6% thought that the app improved their health care.,"['100 patients (50 per group): (1) an experimental group comprising patients using the app + routine medical care (app group) and (2) with routine medical care (control group', 'Older HIV-Infected Patients', 'HIV-infected patients aged 60 years or older']",[],"['Quality of life, adherence to treatment, and clinical parameters', 'patient satisfaction, adherence to treatment, and quality of health care', 'usability of the app and patient satisfaction', 'life expectancy']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}]",100.0,0.0348329,The app was well valued by participants (4.79 [±0.21] of 5.00) and 64.6% thought that the app improved their health care.,"[{'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Puig', 'Affiliation': 'Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Echeverría', 'Affiliation': 'Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Lluch', 'Affiliation': 'Professor of Phychosocial and Mental Health Nursing, School of Nursing, Faculty of Medicine and Health Sciences, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Herms', 'Affiliation': 'Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Estany', 'Affiliation': 'Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bonjoch', 'Affiliation': 'Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain.'}, {'ForeName': 'Arelly', 'Initials': 'A', 'LastName': 'Ornelas', 'Affiliation': 'Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'París', 'Affiliation': 'Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain.'}, {'ForeName': 'Cora', 'Initials': 'C', 'LastName': 'Loste', 'Affiliation': 'Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Sarquella', 'Affiliation': 'Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain.'}, {'ForeName': 'Bonaventura', 'Initials': 'B', 'LastName': 'Clotet', 'Affiliation': 'Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain.'}, {'ForeName': 'Eugènia', 'Initials': 'E', 'LastName': 'Negredo', 'Affiliation': 'Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2020.0098'] 825,32660725,Pregnancy and neonatal outcomes 42 months after application of hyaluronic acid gel following dilation and curettage for miscarriage in women who have experienced at least one previous curettage: follow-up of a randomized controlled trial.,"OBJECTIVE To study whether intrauterine application of auto-crosslinked polymers of hyaluronic acid (ACP) gel after dilation and curettage (D&C) improves reproductive outcomes. DESIGN Follow-up of a prospective randomized trial. SETTING University and university-affiliated teaching hospitals. PATIENT(S) Women with a miscarriage at <14 weeks' gestation with at least one previous D&C were randomized to D&C plus ACP gel (intervention) or D&C alone (control). A hysteroscopy was performed after 8-12 weeks, and if intrauterine adhesion (IUAs) were encountered, adhesiolysis was executed. INTERVENTION(S) Participants received a questionnaire 30 months after treatment. MAIN OUTCOME MEASURE(S) Ongoing pregnancy and outcome of subsequent pregnancies. RESULT(S) Ongoing pregnancies were recorded in 74.6% (50/67) of the intervention group versus 67.2% (43/64) of the control group, and in, respectively, 94.3% (50/53) versus 71.7% (43/60) in the women wishing to conceive. The median times to conception leading to a live birth were, respectively, 21.9 versus 36.1 months. Reduced menstrual blood loss was reported in 7.5% (5/67) versus 20.3% (13/64) and dysmenorrhea in 14.9% (10/67) versus 34.4% (22/64), respectively. CONCLUSION(S) Application of ACP gel following D&C performed after miscarriage seems to have a favorable effect on subsequent reproductive outcomes in women with at least one previous D&C. Given the fact that the study was not powered for reproductive outcomes, the data should be interpreted with caution. The effect may be underestimated due to routine removal of IUAs. DUTCH CLINICAL TRIAL REGISTRY NUMBER NTR 3120.",2020,"Ongoing pregnancies were recorded in 74.6% (50/67) of the intervention group versus 67.2% (43/64) of the control group, and in, respectively, 94.3% (50/53) versus 71.7% (43/60) in the women wishing to conceive.","['University and university-affiliated teaching hospitals', ""\n\n\nWomen with a miscarriage at <14 weeks' gestation with at least one previous D&C"", 'women who have experienced at least one previous curettage', 'women with at least one previous D&C']","['hyaluronic acid (ACP) gel after dilation and curettage (D&C', 'ACP gel', 'hyaluronic acid gel', 'D&C plus ACP gel (intervention) or D&C alone (control', 'dilation and curettage']","['menstrual blood loss', 'median times to conception leading to a live birth', 'dysmenorrhea']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0012358', 'cui_str': 'Dilation and curettage of uterus'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0010468', 'cui_str': 'Curettage'}]","[{'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0012358', 'cui_str': 'Dilation and curettage of uterus'}, {'cui': 'C0968234', 'cui_str': 'auto-cross-linked polysaccharide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0694689', 'cui_str': 'Menstrual blood'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}]",,0.185464,"Ongoing pregnancies were recorded in 74.6% (50/67) of the intervention group versus 67.2% (43/64) of the control group, and in, respectively, 94.3% (50/53) versus 71.7% (43/60) in the women wishing to conceive.","[{'ForeName': 'Angelo B', 'Initials': 'AB', 'LastName': 'Hooker', 'Affiliation': 'Department of Obstetrics and Gynecology, Zaans Medical Center, Zaandam, the Netherlands; Department of Obstetrics and Gynecology, Amsterdam University Medical Center, Vrije Universiteit Medical Center, Amsterdam, the Netherlands. Electronic address: hooker.a@zaansmc.n.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'de Leeuw', 'Affiliation': 'Department of Obstetrics and Gynecology, Amsterdam University Medical Center, Vrije Universiteit Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Jos W R', 'Initials': 'JWR', 'LastName': 'Twisk', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam University Medical Center, Vrije Universiteit Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Hans A M', 'Initials': 'HAM', 'LastName': 'Brölmann', 'Affiliation': 'Department of Obstetrics and Gynecology, Amsterdam University Medical Center, Vrije Universiteit Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Judith A F', 'Initials': 'JAF', 'LastName': 'Huirne', 'Affiliation': 'Department of Obstetrics and Gynecology, Amsterdam University Medical Center, Vrije Universiteit Medical Center, Amsterdam, the Netherlands.'}]",Fertility and sterility,['10.1016/j.fertnstert.2020.04.021'] 826,32662069,Qigong for the treatment of depressive symptoms: Preliminary evidence of neurobiological mechanisms.,"OBJECTIVES Qigong has been shown to effectively reduce depressive symptoms in older adults with chronic physical illness. Here, we sought to evaluate the effects of qigong on serotonin, cortisol, and Brain-derived Neurotropic Factors (BDNF) levels and test their roles as potential mediators of the effects of qigong on depressive symptoms. METHODS Thirty older adults with chronic physical illness participated in a randomized clinical trial. They were randomly assigned to a qigong group (n = 14) or a control group for cognitive training of executive function and memory (n = 16). The participants provided blood and saliva samples at baseline and post-intervention. Levels of cortisol were measured from the salvia samples, and serotonin and BDNF were measured from the blood samples. RESULTS Consistent with the study findings presented in the primary outcome paper, a significant Group × Time interaction effect emerged on depressive symptoms, explained by greater reductions in the qigong group than the control group. Qigong participants had significantly larger increases in serotonin and BDNF, and decreases in cortisol levels, compared with control group participants. Moreover, treatment-related changes in cortisol levels (but not serotonin or BDNF) fully mediated the beneficial effects of qigong on depressive symptoms. CONCLUSION The findings provide preliminary evidence that treatment-related changes in cortisol may mediate the benefits of qigong on depressive symptoms. Given the limitation of small sample size of the present study, future studies with larger sample sizes and more extended follow-up assessment are warranted to determine the reliability of these findings.",2020,"Qigong participants had significantly larger increases in serotonin and BDNF, and decreases in cortisol levels, compared with control group participants.","['older adults with chronic physical illness', 'Thirty older adults with chronic physical illness', 'depressive symptoms']","['Qigong', 'qigong group (n\xa0=\xa014) or a control group for cognitive training of executive function and memory']","['Levels of cortisol', 'cortisol levels', 'serotonin, cortisol, and BDNF levels', 'serotonin and Brain-derived Neurotropic Factors (BDNF', 'serotonin and BDNF', 'depressive symptoms']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]","[{'cui': 'C0282077', 'cui_str': 'Qigong'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",30.0,0.0837699,"Qigong participants had significantly larger increases in serotonin and BDNF, and decreases in cortisol levels, compared with control group participants.","[{'ForeName': 'Erin Yiqing', 'Initials': 'EY', 'LastName': 'Lu', 'Affiliation': 'Neuropsychiatric Rehabilitation Laboratory, Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Kowloon, Hong Kong SAR.'}, {'ForeName': 'Posen', 'Initials': 'P', 'LastName': 'Lee', 'Affiliation': 'Department of Occupational Therapy, I-Shou University, Kaohsiung City, Taiwan.'}, {'ForeName': 'Shuhe', 'Initials': 'S', 'LastName': 'Cai', 'Affiliation': 'Department of Orthopedic Rehabilitation, Fujian University of Traditional Chinese Medicine Subsidiary Rehabilitation Hospital, Fuzhou, Fujian, China.'}, {'ForeName': 'Wendy Wing Yan', 'Initials': 'WWY', 'LastName': 'So', 'Affiliation': 'Neuropsychiatric Rehabilitation Laboratory, Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Kowloon, Hong Kong SAR.'}, {'ForeName': 'Bacon Fung Leung', 'Initials': 'BFL', 'LastName': 'Ng', 'Affiliation': 'Department of Chinese Medicine, Hospital Authority, Hong Kong SAR.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Jensen', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Wai Ming', 'Initials': 'WM', 'LastName': 'Cheung', 'Affiliation': 'Faculty of Education, The University of Hong Kong, Pokfulam Road, Hong Kong SAR.'}, {'ForeName': 'Hector W H', 'Initials': 'HWH', 'LastName': 'Tsang', 'Affiliation': 'Neuropsychiatric Rehabilitation Laboratory, Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Kowloon, Hong Kong SAR.'}]",International journal of geriatric psychiatry,['10.1002/gps.5380'] 827,32662184,Effects of caregiver dementia training in caregiver-patient dyads: A randomized controlled study.,"OBJECTIVES Caregivers for people with dementia (PWD) have reported needing emotional and social support, improved coping strategies, and better information about the illness and available support services. In this study, we aimed to determine the effectiveness of an Australian multicomponent community-based training program that we adapted and implemented in a non-medical Dutch health care setting. METHODS AND DESIGN A randomized controlled trial was performed: 142 dyads of cohabiting caregivers and PwD were randomized to control (care as usual) or intervention (training program) groups and outcomes were compared. Programs lasted 1 week, comprised 14 sessions, and were delivered by specialist staff. We included 16 groups of two to six caregivers. The primary outcome was care-related quality of life (CarerQol-7D) at 3 months. The main secondary outcomes for caregivers were self-rated burden, health and mood symptoms, and for PwD were neuropsychiatric symptoms, quality of life, and agitation. RESULTS No significant difference was observed for the primary outcome. However, caregivers experienced fewer role limitations due to physical function (adjusted mean difference, 13.04; 95% confidence interval [95%CI], 3.15-22.93), emotional function (13.52; 95%CI, 3.76-23.28), and pain reduction (9.43; 95%CI, 1.00-17.86). Positive outcomes identified by qualitative analysis included better acceptance and coping and improved knowledge of dementia and available community services and facilities. CONCLUSION Quantitative analysis showed that the multicomponent course did not affect care-related quality of life but did have a positive effect on experienced role limitations and pain. Qualitative analysis showed that the course met the needs of participating dyads.",2020,"However, caregivers experienced fewer role limitations due to physical function (adjusted mean difference, 13.04; 95% confidence interval [95%CI], 3.15-22.93), emotional function (13.52; 95%CI, 3.76-23.28), and pain reduction (9.43; 95%CI, 1.00-17.86).","['Caregiver-Patient Dyads', 'Caregivers for people with dementia (PWD', '142 dyads of cohabiting caregivers and PwD', '16 groups of two to six caregivers']","['control (care as usual) or intervention (training program', 'Australian multicomponent community-based training program', 'Caregiver Dementia Training']","['emotional function', 'care-related quality of life (CarerQol-7D', 'pain reduction', 'self-rated burden, health and mood symptoms, and for PwD were neuropsychiatric symptoms, quality of life, and agitation', 'acceptance and coping and improved knowledge of dementia and available community services and facilities']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0009482', 'cui_str': 'Community Services'}]",142.0,0.20068,"However, caregivers experienced fewer role limitations due to physical function (adjusted mean difference, 13.04; 95% confidence interval [95%CI], 3.15-22.93), emotional function (13.52; 95%CI, 3.76-23.28), and pain reduction (9.43; 95%CI, 1.00-17.86).","[{'ForeName': 'Elizabeth G', 'Initials': 'EG', 'LastName': 'Birkenhäger-Gillesse', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Wilco P', 'Initials': 'WP', 'LastName': 'Achterberg', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Sarah I M', 'Initials': 'SIM', 'LastName': 'Janus', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Boudewijn J', 'Initials': 'BJ', 'LastName': 'Kollen', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Sytse U', 'Initials': 'SU', 'LastName': 'Zuidema', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}]",International journal of geriatric psychiatry,['10.1002/gps.5378'] 828,32665179,"Efficacy of Ultrasound-Guided Transversus Thoracic Muscle Plane Block on Postoperative Opioid Consumption After Cardiac Surgery: A Prospective, Randomized, Double-Blind Study.","OBJECTIVES The postoperative analgesic efficacy of transversus thoracic muscle plane block (TTMPB) has not yet been evaluated sufficiently. This randomized controlled study evaluated the effect of TTMPB on postoperative opioid consumption in patients undergoing cardiac surgery. DESIGN Prospective, randomized, double-blind study. SETTINGS Single institution, academic university hospital. PARTICIPANTS Forty-eight adult patients having cardiac surgery with median sternotomy. INTERVENTIONS Patients were randomly assigned to receive preoperative ultrasound-guided TTMPB with either 20 mL of 0.25% bupivacaine or saline bilaterally. Postoperative analgesia was administered intravenously in the 2 groups 4 times a day with 1000 mg of paracetamol and patient-controlled analgesia with fentanyl. MEASUREMENTS AND MAIN RESULTS The primary outcome was opioid consumption in the first 24 hours. Secondary outcomes included postoperative pain scores, first analgesic requirement time, rescue analgesia, intensive care discharge time, and side effects. Compared with the control group (median 465 µg, interquartile range 415-585), the transversus thoracic muscle plane (TTMP) group (median 255 µg, interquartile range 235-305) had reduced postoperative 24-hour opioid consumption (p < 0.001). Pain scores were significantly lower in the TTMP group compared with the control group up to 12 hours after surgery both at rest and active movement (p < 0.001). Compared with the TTMP group, the proportion of postoperative nausea and pruritus was statistically higher in the control group (p < 0.001). CONCLUSIONS A single preoperative TTMPB provided effective analgesia and decreased opioid requirements in patients undergoing cardiac surgery.",2020,Pain scores were significantly lower in the TTMP group compared with the control group up to 12 hours after surgery both at rest and active movement (p < 0.001).,"['Single institution, academic university hospital', 'patients undergoing cardiac surgery', 'Forty-eight adult patients having cardiac surgery with median sternotomy']","['TTMP', 'paracetamol and patient-controlled analgesia with fentanyl', 'preoperative ultrasound-guided TTMPB with either 20 mL of 0.25% bupivacaine or saline bilaterally', 'transversus thoracic muscle plane block (TTMPB', 'TTMPB', 'Ultrasound-Guided Transversus Thoracic Muscle Plane Block']","['transversus thoracic muscle plane', 'postoperative opioid consumption', 'postoperative pain scores, first analgesic requirement time, rescue analgesia, intensive care discharge time, and side effects', 'postoperative 24-hour opioid consumption', 'opioid consumption', 'Postoperative Opioid Consumption', 'proportion of postoperative nausea and pruritus', 'postoperative analgesic efficacy', 'Pain scores', 'opioid requirements']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1282959', 'cui_str': 'Median sternotomy'}]","[{'cui': 'C0224337', 'cui_str': 'Skeletal muscle structure of thorax'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0224337', 'cui_str': 'Skeletal muscle structure of thorax'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",48.0,0.568675,Pain scores were significantly lower in the TTMP group compared with the control group up to 12 hours after surgery both at rest and active movement (p < 0.001).,"[{'ForeName': 'Muhammed Enes', 'Initials': 'ME', 'LastName': 'Aydin', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey; Clinical Research, Development and Design Application and Research Center, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ahiskalioglu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey; Clinical Research, Development and Design Application and Research Center, Ataturk University School of Medicine, Erzurum, Turkey. Electronic address: aliahiskalioglu@hotmail.com.'}, {'ForeName': 'Irem', 'Initials': 'I', 'LastName': 'Ates', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Ibrahim Hakki', 'Initials': 'IH', 'LastName': 'Tor', 'Affiliation': 'Department of Anesthesiology and Reanimation, University of Health Sciences School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Ferhat', 'Initials': 'F', 'LastName': 'Borulu', 'Affiliation': 'Department of Cardiovascular Surgery, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Ozlem Dilara', 'Initials': 'OD', 'LastName': 'Erguney', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Mine', 'Initials': 'M', 'LastName': 'Celik', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey; Clinical Research, Development and Design Application and Research Center, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Nazim', 'Initials': 'N', 'LastName': 'Dogan', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.06.044'] 829,32669450,Ixekizumab Improves Functioning and Health in the Treatment of Radiographic Axial Spondyloarthritis: Week 52 Results from 2 Pivotal Studies.,"OBJECTIVE This study evaluated the effect of ixekizumab (IXE) on self-reported functioning and health in patients with radiographic axial spondyloarthritis (r-axSpA) who were either biological disease-modifying antirheumatic drug (bDMARD)-naïve or failed at least 1 tumor necrosis factor inhibitor (TNFi). METHODS In 2 multicenter, randomized, double-blind, placebo-controlled, and active-controlled (bDMARD-naïve only) trials, patients with r-axSpA were randomly assigned to receive 80 mg of IXE [every 2 weeks (Q2W) or every 4 weeks (Q4W)], placebo (PBO), or adalimumab (ADA; bDMARD-naïve only). After 16 weeks, patients who received PBO or ADA were rerandomized to receive IXE (Q2W or Q4W) up to Week 52. Functioning and health were measured by the generic 36-item Short Form Health Survey (SF-36) and the disease-specific Assessment of Spondyloarthritis international Society Health Index (ASAS HI). Societal health utility was assessed by the 5-level EuroQol-5 Dimension (EQ-5D-5L). RESULTS At Week 16, both doses of IXE in bDMARD-naïve and TNFi-experienced patients resulted in larger improvement in SF-36, ASAS HI, and EQ-5D-5L versus placebo. For SF-36, the largest improvements were seen for the domains of bodily pain, physical function, and role physical. A larger proportion of patients reaching improvement in ASAS HI ≥ 3 as well as an achievement of ASAS HI good health status was reported in patients treated with IXE. Improvements were maintained through Week 52. CONCLUSION IXE significantly improved functioning and health as assessed by both generic and disease-specific measures, as well as societal health utility values in patients with r-axSpA, as measured by SF-36, ASAS HI, and EQ-5D-5L at Week 16, and improvements were sustained through 52 weeks.",2021,"For SF-36, the largest improvements were seen for the domains of bodily pain, physical function, and role physical.","['Radiographic Axial Spondyloarthritis', 'patients with radiographic axial spondyloarthritis (r-axSpA) who were either biologic disease modifying antirheumatic drugs naïve (bDMARD-naïve) or failed at least 1 tumor necrosis factor inhibitor (TNFi']","['placebo or adalimumab', 'placebo, or adalimumab (bDMARD-naïve only', 'ixekizumab (Q2W or Q4W', 'ixekizumab', 'Ixekizumab', 'placebo']","['bodily pain, physical function, and role physical', 'European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L', 'societal health utility values', 'generic Short Form Health Survey 36-item (SF-36) and the diseasespecific ASAS Health Index (ASAS HI', 'ASAS HI ≥3, ASAS HI good health status', 'Functioning and health', 'functioning and health', 'SF-36, ASAS HI, and EQ-5D-5L versus placebo', 'SF-36, ASAS HI, and EQ-5D-5L', 'Societal health utility']","[{'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C3537192', 'cui_str': 'TNF Antagonists'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C3489764', 'cui_str': 'ixekizumab'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",,0.28825,"For SF-36, the largest improvements were seen for the domains of bodily pain, physical function, and role physical.","[{'ForeName': 'Uta', 'Initials': 'U', 'LastName': 'Kiltz', 'Affiliation': 'U. Kiltz, MD, J. Braun, MD, PhD, Rheumazentrum Ruhrgebiet, Herne, and Ruhr-Universität Bochum, Bochum, Germany; uta.kiltz@elisabethgruppe.de.'}, {'ForeName': 'James Cheng-Chung', 'Initials': 'JC', 'LastName': 'Wei', 'Affiliation': 'J. Cheng-Chung Wei, MD, PhD, Institute of Medicine, Chung Shan Medical University, Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'D. van der Heijde, MD, PhD, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'van den Bosch', 'Affiliation': 'F. van den Bosch, MD, PhD, Department of Internal Medicine and Pediatrics, Ghent University, VIB Center for Inflammation Research, Ghent, Belgium.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Walsh', 'Affiliation': 'J.A. Walsh, MD, University of Utah School of Medicine and Salt Lake City Veterans Affairs Medical Center, Salt Lake City, Utah, USA.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Boonen', 'Affiliation': 'A. Boonen, MD, PhD, Rheumatology, Maastricht University Medical Center, and Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Lianne S', 'Initials': 'LS', 'LastName': 'Gensler', 'Affiliation': 'L.S. Gensler, MD, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Hunter', 'Affiliation': 'T. Hunter, PhD, H. Carlier, MD, Y. Dong, PhD, X. Li, PhD, R. Bolce, MSN, Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Carlier', 'Affiliation': 'T. Hunter, PhD, H. Carlier, MD, Y. Dong, PhD, X. Li, PhD, R. Bolce, MSN, Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'T. Hunter, PhD, H. Carlier, MD, Y. Dong, PhD, X. Li, PhD, R. Bolce, MSN, Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Xiaoqi', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'T. Hunter, PhD, H. Carlier, MD, Y. Dong, PhD, X. Li, PhD, R. Bolce, MSN, Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Bolce', 'Affiliation': 'T. Hunter, PhD, H. Carlier, MD, Y. Dong, PhD, X. Li, PhD, R. Bolce, MSN, Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Strand', 'Affiliation': 'V. Strand, MD, Stanford University School of Medicine, Palo Alto, California, USA.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Braun', 'Affiliation': 'U. Kiltz, MD, J. Braun, MD, PhD, Rheumazentrum Ruhrgebiet, Herne, and Ruhr-Universität Bochum, Bochum, Germany.'}]",The Journal of rheumatology,['10.3899/jrheum.200093'] 830,32678054,The effect of dexmedetomidine on vasopressor requirements in patients with septic shock: a subgroup analysis of the Sedation Practice in Intensive Care Evaluation [SPICE III] Trial.,"BACKGROUND Septic shock is associated with decreased vasopressor responsiveness. Experimental data suggest that central alpha2-agonists like dexmedetomidine (DEX) increase vasopressor responsiveness and reduce catecholamine requirements in septic shock. However, DEX may also cause hypotension and bradycardia. Thus, it remains unclear whether DEX is hemodynamically safe or helpful in this setting. METHODS In this post hoc subgroup analysis of the Sedation Practice in Intensive Care Evaluation (SPICE III) trial, an international randomized trial comparing early sedation with dexmedetomidine to usual care in critically patients receiving mechanical ventilation, we studied patients with septic shock admitted to two tertiary ICUs in Australia and Switzerland. The primary outcome was vasopressor requirements in the first 48 h after randomization, expressed as noradrenaline equivalent dose (NEq [μg/kg/min] = noradrenaline + adrenaline + vasopressin/0.4). RESULTS Between November 2013 and February 2018, 417 patients were recruited into the SPICE III trial at both sites. Eighty-three patients with septic shock were included in this subgroup analysis. Of these, 44 (53%) received DEX and 39 (47%) usual care. Vasopressor requirements in the first 48 h were similar between the two groups. Median NEq dose was 0.03 [0.01, 0.07] μg/kg/min in the DEX group and 0.04 [0.01, 0.16] μg/kg/min in the usual care group (p = 0.17). However, patients in the DEX group had a lower NEq/MAP ratio, indicating lower vasopressor requirements to maintain the target MAP. Moreover, on adjusted multivariable analysis, higher dexmedetomidine dose was associated with a lower NEq/MAP ratio. CONCLUSIONS In critically ill patients with septic shock, patients in the DEX group received similar vasopressor doses in the first 48 h compared to the usual care group. On multivariable adjusted analysis, dexmedetomidine appeared to be associated with lower vasopressor requirements to maintain the target MAP. TRIAL REGISTRATION The SPICE III trial was registered at ClinicalTrials.gov ( NCT01728558 ).",2020,Vasopressor requirements in the first 48 h were similar between the two groups.,"['critically ill patients with septic shock, patients in the', 'Intensive Care Evaluation [SPICE\xa0III', 'septic shock', 'patients with septic shock', 'Eighty-three patients with septic shock', 'Between November 2013 and February 2018, 417 patients were recruited into the SPICE III trial at both sites', 'critically patients receiving mechanical ventilation, we studied patients with septic shock admitted to two tertiary ICUs in Australia and Switzerland']","['dexmedetomidine (DEX', 'dexmedetomidine', 'DEX']","['catecholamine requirements', 'hypotension and bradycardia', 'Vasopressor requirements', 'vasopressor responsiveness', 'vasopressor requirements', 'lower NEq/MAP ratio']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0037910', 'cui_str': 'Spice'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C5191297', 'cui_str': '417'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0007412', 'cui_str': 'Catecholamine'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",83.0,0.380463,Vasopressor requirements in the first 48 h were similar between the two groups.,"[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cioccari', 'Affiliation': 'Department of Intensive Care, Austin Hospital, The University of Melbourne, Melbourne, Australia. luca.cioccari@insel.ch.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Luethi', 'Affiliation': 'Department of Intensive Care, Austin Hospital, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bailey', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Shehabi', 'Affiliation': 'Critical Care and Perioperative Services, School of Clinical Sciences, Monash University, Monash Health, Melbourne, Australia.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Howe', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Anna S', 'Initials': 'AS', 'LastName': 'Messmer', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Helena K', 'Initials': 'HK', 'LastName': 'Proimos', 'Affiliation': 'Department of Intensive Care, Austin Hospital, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Peck', 'Affiliation': 'Department of Intensive Care, Austin Hospital, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Young', 'Affiliation': 'Department of Intensive Care, Austin Hospital, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Eastwood', 'Affiliation': 'Department of Intensive Care, Austin Hospital, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Tobias M', 'Initials': 'TM', 'LastName': 'Merz', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Takala', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Stephan M', 'Initials': 'SM', 'LastName': 'Jakob', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Department of Intensive Care, Austin Hospital, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Critical care (London, England)",['10.1186/s13054-020-03115-x'] 831,32669717,Investigation of the safety and feasibility of AAV1/SERCA2a gene transfer in patients with chronic heart failure supported with a left ventricular assist device - the SERCA-LVAD TRIAL.,"The SERCA-LVAD trial was a phase 2a trial assessing the safety and feasibility of delivering an adeno-associated vector 1 carrying the cardiac isoform of the sarcoplasmic reticulum calcium ATPase (AAV1/SERCA2a) to adult chronic heart failure patients implanted with a left ventricular assist device. The SERCA-LVAD trial was one of a program of AAV1/SERCA2a cardiac gene therapy trials including CUPID1, CUPID 2 and AGENT trials. Enroled subjects were randomised to receive a single intracoronary infusion of 1 × 10 13 DNase-resistant AAV1/SERCA2a particles or a placebo solution in a double-blinded design, stratified by presence of neutralising antibodies to AAV. Elective endomyocardial biopsy was performed at 6 months unless the subject had undergone cardiac transplantation, with myocardial samples assessed for the presence of exogenous viral DNA from the treatment vector. Safety assessments including ELISPOT were serially performed. Although designed as a 24 subject trial, recruitment was stopped after five subjects had been randomised and received infusion due to the neutral result from the CUPID 2 trial. Here we describe the results from the 5 patients at 3 years follow up, which confirmed that viral DNA was delivered to the failing human heart in 2 patients receiving gene therapy with vector detectable at follow up endomyocardial biopsy or cardiac transplantation. Absolute levels of detectable transgene DNA were low, and no functional benefit was observed. There were no safety concerns in this small cohort. This trial identified some of the challenges of performing gene therapy trials in this LVAD patient cohort which may help guide future trial design.",2020,"Absolute levels of detectable transgene DNA were low, and no functional benefit was observed.","['adult chronic heart failure patients implanted with a left ventricular assist device', 'patients with chronic heart failure supported with a left ventricular assist device - the SERCA-LVAD TRIAL']","['Elective endomyocardial biopsy', 'sarcoplasmic reticulum calcium ATPase (AAV1/SERCA2a', 'single intracoronary infusion of 1\u2009×\u200910 13 DNase-resistant AAV1/SERCA2a particles or a placebo solution', 'AAV1/SERCA2a gene transfer', 'failing human heart in 2 patients receiving gene therapy with vector detectable at follow up endomyocardial biopsy or cardiac transplantation']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0085842', 'cui_str': 'Ventricular assist device'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0189785', 'cui_str': 'Endomyocardial biopsy'}, {'cui': 'C0916181', 'cui_str': 'Calcium-Transporting ATPases, Sarcoplasmic Reticulum'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0595454', 'cui_str': 'Intracoronary route'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0011519', 'cui_str': 'Deoxyribonuclease I'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}]",[],,0.220029,"Absolute levels of detectable transgene DNA were low, and no functional benefit was observed.","[{'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Lyon', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK. a.lyon@imperial.ac.uk.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Babalis', 'Affiliation': 'Imperial Clinical Trials Unit (ICTU), School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Morley-Smith', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hedger', 'Affiliation': 'NIHR Cardiovascular Biomedical Research Unit, Royal Brompton and Harefield Hospitals NHS Trust, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Suarez Barrientos', 'Affiliation': 'NIHR Cardiovascular Biomedical Research Unit, Royal Brompton and Harefield Hospitals NHS Trust, London, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Foldes', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'L S', 'Initials': 'LS', 'LastName': 'Couch', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Chowdhury', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Tzortzis', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'N S', 'Initials': 'NS', 'LastName': 'Peters', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Rog-Zielinska', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'H-Y', 'Initials': 'HY', 'LastName': 'Yang', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Welch', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'C T', 'Initials': 'CT', 'LastName': 'Bowles', 'Affiliation': 'NIHR Cardiovascular Biomedical Research Unit, Royal Brompton and Harefield Hospitals NHS Trust, London, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rahman Haley', 'Affiliation': 'NIHR Cardiovascular Biomedical Research Unit, Royal Brompton and Harefield Hospitals NHS Trust, London, UK.'}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Bell', 'Affiliation': 'Department of Histopathology, Royal Brompton and Harefield Hospitals NHS Trust, Freiburg, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rice', 'Affiliation': 'Department of Histopathology, Royal Brompton and Harefield Hospitals NHS Trust, Freiburg, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Sasikaran', 'Affiliation': 'Imperial Clinical Trials Unit (ICTU), School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Johnson', 'Affiliation': 'Imperial Clinical Trials Unit (ICTU), School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Falaschetti', 'Affiliation': 'Imperial Clinical Trials Unit (ICTU), School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Parameshwar', 'Affiliation': 'Royal Papworth Hospital NHS Trust, Cambridge, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lewis', 'Affiliation': 'Royal Papworth Hospital NHS Trust, Cambridge, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tsui', 'Affiliation': 'Royal Papworth Hospital NHS Trust, Cambridge, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Simon', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Pepper', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Rudy', 'Affiliation': 'Celladon Corporation, San Diego, CA, USA.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Zsebo', 'Affiliation': 'Celladon Corporation, San Diego, CA, USA.'}, {'ForeName': 'K T', 'Initials': 'KT', 'LastName': 'Macleod', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Terracciano', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Hajjar', 'Affiliation': 'Phospholamban Foundation, Amsterdam, Netherlands.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Banner', 'Affiliation': 'NIHR Cardiovascular Biomedical Research Unit, Royal Brompton and Harefield Hospitals NHS Trust, London, UK.'}, {'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'Harding', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}]",Gene therapy,['10.1038/s41434-020-0171-7'] 832,32669026,Arthroscopic confirmation of femoral button deployment avoids post-operative X-ray in ACL reconstruction.,"BACKGROUND Anterior cruciate ligament reconstruction (ACLR) with cortical fixation adjustable-loop devices are associated with high potential risk of button malpositioning or interposition of the soft tissue between lateral femoral cortex and the button. Surgeons usually use X-rays to check and avoid button malposition and soft tissue interposition. Arthroscopic visualization of button position through the lateral gutter has been described. With this technique, it is possible for identification and correction of femoral button malalignment in the setting of soft tissue interposition and it could avoid the use of post-operative X-ray. METHODS A total of 193 ACLR were included and patients were randomized into two groups. The first series (Group A) of 112 patients who sustained an ACLR with post-operative X-ray to assess the position of the femoral button and the second series (Group B) of 81 patients who sustained an ACLR with an arthroscopic exploration of the button followed by post-operative X-ray. RESULTS On the post-operative radiographs, tissue interposition between the button and femoral cortex was found in nine cases of 112 in Group A (8%) and in zero case of 81 in Group B (0%). In six cases (7,4%) in Group B, there was a soft tissue interposition between the button and femoral cortex as visualized by arthroscopic confirmation and before post-operative X-ray; in all these cases, the soft tissue was removed, and the button was in contact with the bone in all X-ray made in the Group B. CONCLUSIONS This technique allows for identification and correction of femoral button malalignment in the setting of soft tissue interposition and reduces the use of post-operative X-ray.",2021,"In 6 cases (7,4%) in the Group B there was a soft tissue interposition between the button and femoral cortex as visualized by arthroscopic confirmation and before post operative X-ray; in all these cases the soft tissue was removed, and the button was in contact with the bone in all X-ray made in the group B. Conclusions: This technique could allows identification and correction of femoral button malalignment in the setting of soft tissue interposition and could reduce the use of postoperative x-ray.","['A total of 193 ACLR', '112 patients who sustained an ACLR with post operative X-ray to assess the position of the femoral button and the second series (Group B) of 81 patients who sustained an ACLR with an arthroscopic exploration of the button followed by post operative X-ray']","['Arthroscopic Confirmation of Femoral Button Deployment Avoids Post Operative X-ray in ACL Reconstruction', 'Anterior cruciate ligament reconstruction (ACLR) with cortical fixation adjustable-loop devices']",['soft tissue interposition'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0453985', 'cui_str': 'Button'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C1280903', 'cui_str': 'Exploration procedure'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0521091', 'cui_str': 'Confirmation of'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0453985', 'cui_str': 'Button'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0225317', 'cui_str': 'Soft tissue'}]",193.0,0.0175416,"In 6 cases (7,4%) in the Group B there was a soft tissue interposition between the button and femoral cortex as visualized by arthroscopic confirmation and before post operative X-ray; in all these cases the soft tissue was removed, and the button was in contact with the bone in all X-ray made in the group B. Conclusions: This technique could allows identification and correction of femoral button malalignment in the setting of soft tissue interposition and could reduce the use of postoperative x-ray.","[{'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Matassi', 'Affiliation': 'Orthopaedic Clinic, University of Florence, AOU Careggi, Florence, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Sani', 'Affiliation': 'Orthopaedic Clinic, University of Florence, AOU Careggi, Florence, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Innocenti', 'Affiliation': 'Orthopaedic Clinic, University of Florence, AOU Careggi, Florence, Italy.'}, {'ForeName': 'Niccolò', 'Initials': 'N', 'LastName': 'Giabbani', 'Affiliation': 'Orthopaedic Clinic, University of Florence, AOU Careggi, Florence, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Civinini', 'Affiliation': 'Orthopaedic Clinic, University of Florence, AOU Careggi, Florence, Italy.'}]",The Physician and sportsmedicine,['10.1080/00913847.2020.1796469'] 833,32675536,Five Year Follow-up of a Randomized Controlled Trial of Laparoscopic Repair of Very Large Hiatus Hernia With Sutures Versus Absorbable Versus Nonabsorbable Mesh.,"OBJECTIVE To determine whether absorbable or nonabsorbable mesh repair of large hiatus hernias is followed by less recurrences at late follow-up compared to sutured repair. SUMMARY OF BACKGROUND DATA Radiological recurrences have been reported in up to 30% of patients after repair of large hiatus hernias, and mesh repair has been proposed as a solution. Earlier trials have revealed mixed outcomes and early outcomes from a trial reported previously revealed no short-term advantages for mesh repair. METHODS Multicentre prospective double-blind randomized controlled trial of 3 methods of hiatus hernia repair; sutures versus absorbable mesh versus nonabsorbable mesh. Primary outcome - hernia recurrence assessed by barium meal X-ray and endoscopy at 3-4 years. Secondary outcomes - clinical symptom scores at 2, 3, and 5 years. RESULTS 126 patients were enrolled - 43 sutures, 41 absorbable mesh, and 42 nonabsorbable mesh. Clinical outcomes were obtained at 5 years in 89.9%, and objective follow-up was obtained in 72.3%. A recurrent hernia (any size) was identified in 39.3% after suture repair, 56.7% - absorbable mesh, and 42.9% - nonabsorbable mesh (P = 0.371). Clinical outcomes were similar at 5 years, except chest pain, diarrhea, and bloat symptoms which were more common after repair with absorbable mesh. CONCLUSIONS No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh. The longer-term results from this trial do not support mesh repair for large hiatus hernias.",2020,"No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh.","['126 patients were enrolled - 43 sutures, 41 absorbable mesh, and 42 nonabsorbable mesh']","['hiatus hernia repair; sutures versus absorbable mesh versus nonabsorbable mesh', 'Laparoscopic Repair of Very Large Hiatus Hernia With Sutures Versus Absorbable Versus Nonabsorbable Mesh', 'absorbable or nonabsorbable mesh repair']","['chest pain, diarrhea, and bloat symptoms', 'clinical symptom scores at 2, 3, and 5 years', 'recurrent hernia', 'hernia recurrence assessed by barium meal X-ray and endoscopy']","[{'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0450155', 'cui_str': 'Nonabsorbable mesh'}]","[{'cui': 'C0014857', 'cui_str': 'Repair of paraesophageal diaphragmatic hernia'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0450155', 'cui_str': 'Nonabsorbable mesh'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0450093', 'cui_str': 'Very large'}, {'cui': 'C0376710', 'cui_str': 'Sliding hiatus hernia'}]","[{'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1291077', 'cui_str': 'Abdominal bloating'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0412103', 'cui_str': 'Barium meal'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]",126.0,0.479725,"No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh.","[{'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Watson', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Thompson', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Devitt', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Aly', 'Affiliation': 'University of Melbourne Department of Surgery, Austin Hospital, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Irvine', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Simon D', 'Initials': 'SD', 'LastName': 'Woods', 'Affiliation': 'Cabrini Hospital, Malvern, Victoria, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Gan', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Game', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Glyn G', 'Initials': 'GG', 'LastName': 'Jamieson', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}]",Annals of surgery,['10.1097/SLA.0000000000003734'] 834,32676780,"Combined use of tranexamic acid and rivaroxaban in posterior lumbar interbody fusion safely reduces blood loss and transfusion rates without increasing the risk of thrombosis-a prospective, stratified, randomized, controlled trial.","PURPOSE This prospective, stratified, randomized, single-blind, placebo-controlled multicentre study investigated the safety and effectiveness of reducing blood loss and preventing venous thromboembolism (VTE) during posterior lumbar interbody fusion (PLIF) in patients with stenosis or spondylolisthesis using the combination of tranexamic acid (TXA) and rivaroxaban. METHODS The Autar score was evaluated in patients after admission. Patients with an Autar score ≤ 10 were randomized to group A or B. Group A was the placebo-controlled group. Patients in group B were treated with 1 g TXA via intravenous injection and 1 g TXA for external use. Patients with an Autar score > 10 were randomized to group C or D. Patients in group C were treated with 10-mg rivaroxaban qd for 35 days after surgery. Patients in group D received the same treatment as those in group B intra-operatively and as those in group C post-operatively. RESULTS A total of 599 patients from eight hospitals participated in this clinical trial. The total blood loss, intra-operative blood loss, and drainage volume were reduced by the administration of TXA (group A vs group B, P < 0.01; group C vs group D, P < 0.01), and the blood transfusion rate was also decreased (group A vs group B, P < 0.01; group C vs group D, P < 0.01). There were no significant differences (P > 0.05) in the VTE incidence rates among group A and group B. In patients with high-risk thrombosis, the number of patients with VTE was only three and seven after the application of rivaroxaban. Epidural haematoma was not discovered in any patients in our trial. CONCLUSION The combined application of tranexamic acid and rivaroxaban significantly reduced the amount of blood loss and the transfusion rate during PLIF surgery and avoided an increase in the probability of thrombosis and the occurrence of epidural haematoma. TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION ChiCTR-1800016430 2018-06-01.",2020,"The combined application of tranexamic acid and rivaroxaban significantly reduced the amount of blood loss and the transfusion rate during PLIF surgery and avoided an increase in the probability of thrombosis and the occurrence of epidural haematoma. ","['Patients with an Autar score\u2009>\u200910', '599 patients from eight hospitals participated in this clinical trial', 'Patients with an Autar score\u2009≤\u200910', 'patients with high-risk thrombosis', 'patients with stenosis or spondylolisthesis using the combination of']","['tranexamic acid and rivaroxaban', 'TXA', 'posterior lumbar interbody fusion (PLIF', 'tranexamic acid (TXA) and rivaroxaban', '10-mg rivaroxaban', 'rivaroxaban', 'TXA via intravenous injection and 1\xa0g TXA', 'placebo']","['VTE incidence rates', 'blood loss and preventing venous thromboembolism (VTE', 'blood transfusion rate', 'Epidural haematoma', 'probability of thrombosis', 'blood loss and transfusion rates', 'total blood loss, intra-operative blood loss, and drainage volume', 'blood loss and the transfusion rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0038016', 'cui_str': 'Spondylolisthesis'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0021494', 'cui_str': 'Intravenous injection'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0238154', 'cui_str': 'Epidural hemorrhage'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",599.0,0.107914,"The combined application of tranexamic acid and rivaroxaban significantly reduced the amount of blood loss and the transfusion rate during PLIF surgery and avoided an increase in the probability of thrombosis and the occurrence of epidural haematoma. ","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Spine Surgery, Qilu Hospital, Shandong University, 107, West Culture Road, Lixia District, Jinan, China.'}, {'ForeName': 'Yanming', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Spine Surgery, Affiliated Hospital of Jining Medical University, 89 Guhuai Road, Jining, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Spine Surgery, Binzhou Medical University Hospital, 661 Huanghe 2nd Road, Binzhou, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'Department of Spine Surgery, Shandong Provincial Qianfoshan Hospital, 16766 Jingshi Road, Jinan, China.'}, {'ForeName': 'Tingjin', 'Initials': 'T', 'LastName': 'Guan', 'Affiliation': 'Department of Spine Surgery, The First Hospital of Zibo City, 4, East Emeishan Road, Boshan District, Zibo, China.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Yue', 'Affiliation': ""Department of Spine Surgery, Dezhou People's Hospital, 1166, Dongfanghong West Road, Decheng District, Dezhou, China.""}, {'ForeName': 'Haipeng', 'Initials': 'H', 'LastName': 'Xue', 'Affiliation': 'Department of Spine Surgery, Shandong Provincial Hospital of Traditional Chinese Medicine, 16369 Jingshi Road, Jinan, China.'}, {'ForeName': 'Hongming', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Spine Surgery, Linyi Central Hospital, 17, Jiankang Road, Yishui County, Linyi, China.'}, {'ForeName': 'Guangjun', 'Initials': 'G', 'LastName': 'Jiao', 'Affiliation': 'Department of Spine Surgery, Qilu Hospital, Shandong University, 107, West Culture Road, Lixia District, Jinan, China.'}, {'ForeName': 'Wenliang', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Spine Surgery, Qilu Hospital, Shandong University, 107, West Culture Road, Lixia District, Jinan, China.'}, {'ForeName': 'Hongliang', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Spine Surgery, Qilu Hospital, Shandong University, 107, West Culture Road, Lixia District, Jinan, China.'}, {'ForeName': 'Haichun', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Spine Surgery, Qilu Hospital, Shandong University, 107, West Culture Road, Lixia District, Jinan, China.'}, {'ForeName': 'Chunyang', 'Initials': 'C', 'LastName': 'Meng', 'Affiliation': 'Department of Spine Surgery, Affiliated Hospital of Jining Medical University, 89 Guhuai Road, Jining, China.'}, {'ForeName': 'Zhaozhong', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Spine Surgery, Binzhou Medical University Hospital, 661 Huanghe 2nd Road, Binzhou, China.'}, {'ForeName': 'Yunzhen', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Spine Surgery, Qilu Hospital, Shandong University, 107, West Culture Road, Lixia District, Jinan, China. qilucyz@yeah.net.'}]",International orthopaedics,['10.1007/s00264-020-04699-3'] 835,32678879,"CODEL: phase III study of RT, RT + TMZ, or TMZ for newly diagnosed 1p/19q codeleted oligodendroglioma. Analysis from the initial study design.","BACKGROUND We report the analysis involving patients treated on the initial CODEL design. METHODS Adults (>18) with newly diagnosed 1p/19q World Health Organization (WHO) grade III oligodendroglioma were randomized to radiotherapy (RT; 5940 centigray ) alone (arm A); RT with concomitant and adjuvant temozolomide (TMZ) (arm B); or TMZ alone (arm C). Primary endpoint was overall survival (OS), arm A versus B. Secondary comparisons were performed for OS and progression-free survival (PFS), comparing pooled RT arms versus TMZ-alone arm. RESULTS Thirty-six patients were randomized equally. At median follow-up of 7.5 years, 83.3% (10/12) TMZ-alone patients progressed, versus 37.5% (9/24) on the RT arms. PFS was significantly shorter in TMZ-alone patients compared with RT patients (hazard ratio [HR] = 3.12; 95% CI: 1.26, 7.69; P = 0.014). Death from disease progression occurred in 3/12 (25%) of TMZ-alone patients and 4/24 (16.7%) on the RT arms. OS did not statistically differ between arms (comparison underpowered). After adjustment for isocitrate dehydrogenase (IDH) status (mutated/wildtype) in a Cox regression model utilizing IDH and RT treatment status as covariables (arm C vs pooled arms A + B), PFS remained shorter for patients not receiving RT (HR = 3.33; 95% CI: 1.31, 8.45; P = 0.011), but not OS ((HR = 2.78; 95% CI: 0.58, 13.22, P = 0.20). Grade 3+ adverse events occurred in 25%, 42%, and 33% of patients (arms A, B, and C). There were no differences between arms in neurocognitive decline comparing baseline to 3 months. CONCLUSIONS TMZ-alone patients experienced significantly shorter PFS than patients treated on the RT arms. The ongoing CODEL trial has been redesigned to compare RT + PCV versus RT + TMZ.",2021,"Arm A versus B. Secondary comparisons were performed for OS and progression-free survival (PFS), comparing pooled RT arms versus TMZ-alone arm. ","['newly-diagnosed\xa01p/19q', 'Thirty-six patients', 'patients treated on\xa0the initial CODEL design', 'Adults (>18) with newly-diagnosed 1p/19q WHO grade III oligodendroglioma were randomized to RT (5940 cGy) alone (Arm A']","['TMZ', 'RT with concomitant and adjuvant temozolomide (TMZ) (Arm B); or TMZ', 'RT, RT + Temozolomide (TMZ), or TMZ', 'RT+PCV versus RT+TMZ']","['PFS', 'OS', 'Grade 3+ adverse events', 'OS and progression-free survival (PFS', 'neurocognitive decline', 'Death from disease progression', 'overall survival (OS']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0028945', 'cui_str': 'Oligodendroglioma, no ICD-O subtype'}, {'cui': 'C0556645', 'cui_str': 'cGy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",36.0,0.0848083,"Arm A versus B. Secondary comparisons were performed for OS and progression-free survival (PFS), comparing pooled RT arms versus TMZ-alone arm. ","[{'ForeName': 'Kurt A', 'Initials': 'KA', 'LastName': 'Jaeckle', 'Affiliation': 'Department of Neurology, Mayo Clinic Florida, Jacksonville, Florida, USA.'}, {'ForeName': 'Karla V', 'Initials': 'KV', 'LastName': 'Ballman', 'Affiliation': 'Alliance Statistics and Data Center, Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'van den Bent', 'Affiliation': 'Brain Tumor Center, Erasmus MC Cancer Center, Erasmus University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Giannini', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Evanthia', 'Initials': 'E', 'LastName': 'Galanis', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Brown', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Jenkins', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'J Gregory', 'Initials': 'JG', 'LastName': 'Cairncross', 'Affiliation': 'Department of Clinical Neurosciences, Arnie Charbonneau Cancer Institute, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Wick', 'Affiliation': 'Neurologische Klinik, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weller', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Kenneth D', 'Initials': 'KD', 'LastName': 'Aldape', 'Affiliation': 'Department of Neuropathology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Jesse G', 'Initials': 'JG', 'LastName': 'Dixon', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'S Keith', 'Initials': 'SK', 'LastName': 'Anderson', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Jane H', 'Initials': 'JH', 'LastName': 'Cerhan', 'Affiliation': 'Departments of Psychiatry and Psychology, Houston, Texas, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Wefel', 'Affiliation': 'Departments of Neuro-Oncology and Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Klein', 'Affiliation': 'Department of Medical Psychology, VU University Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Grossman', 'Affiliation': 'Department of Oncology, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schiff', 'Affiliation': 'Department of Neurology, University of Virginia, Charlottesville, Virginia, USA.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Raizer', 'Affiliation': 'Department of Neurology, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Dhermain', 'Affiliation': 'Department of Radiation Therapy, Gustave Roussy Cancer Institute, Villejuif, France.'}, {'ForeName': 'Donald G', 'Initials': 'DG', 'LastName': 'Nordstrom', 'Affiliation': 'Medical Oncology, France Abben Cancer Center, Spencer, Iowa, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Flynn', 'Affiliation': 'Medical Oncology, Minnesota Oncology, Northfield, Minnesota, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Vogelbaum', 'Affiliation': 'Department of Neurosurgery, Cleveland Clinic, Cleveland, Ohio, USA.'}]",Neuro-oncology,['10.1093/neuonc/noaa168'] 836,32680754,"Efficacy of Adductor Canal Block Combined With Additional Analgesic Methods for Postoperative Analgesia in Total Knee Arthroplasty: A Prospective, Double-Blind, Randomized Controlled Study.","BACKGROUND The aim of this study is to evaluate the efficacy of adductor canal block (ACB) combined with additional analgesic methods in total knee arthroplasty (TKA) and investigate whether blocking the sensory nerves that are distributed in the posterior and lateral aspect of knee could improve postoperative pain control. METHODS Two hundred scheduled patients for TKA were randomly allocated into 4 groups: Group A received ACB combined with iPACK (interspace between the popliteal artery and capsule of the knee) block and lateral femoral cutaneous nerve block (LFCNB); Group B received ACB combined with iPACK block; Group C received ACB combined with LFCNB; and Group D received ACB only. Postoperative pain score was the main primary outcome. Secondary outcomes included the morphine consumption and analgesic duration. Other outcomes included knee range of motion, quadriceps strength, ambulation, Knee Society Score, Western Ontario and McMaster Universities Osteoarthritis Index physical function, timed up and go (TUG) test, and complications. RESULTS Groups A, B, and C had lower postoperative pain scores within 12 hours at rest and 8 hours with activity than Group D (P < .05). In addition, Group A had lower morphine consumption than both Group C (P < .05) and Group D (P < .01). Group A had the longest analgesic duration (19.21 ± 3.22 hours) among all groups. There were no significant differences among the groups in terms of mobility and complication after surgery. CONCLUSION Combining ACB with both iPACK and LFCNB is an effective method for decreasing early postoperative pain in TKA without increasing the complications or affecting the early rehabilitation.",2020,"In addition, Group A had lower morphine consumption than both Group C (P < .05) and Group D (P < .01).","['total knee arthroplasty (TKA', 'Total Knee Arthroplasty', 'Two hundred scheduled patients for TKA']","['ACB combined with iPACK (interspace between the popliteal artery and capsule of the knee) block and lateral femoral cutaneous nerve block (LFCNB); Group B received ACB combined with iPACK block', 'Adductor Canal Block Combined With Additional Analgesic Methods', 'adductor canal block (ACB) combined with additional analgesic methods', 'ACB combined with LFCNB', 'iPACK and LFCNB']","['mobility and complication', 'knee range of motion, quadriceps strength, ambulation, Knee Society Score, Western Ontario and McMaster Universities Osteoarthritis Index physical function, timed up and go (TUG) test, and complications', 'longest analgesic duration', 'postoperative pain scores', 'morphine consumption', 'early postoperative pain', 'morphine consumption and analgesic duration', 'Postoperative pain score']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032649', 'cui_str': 'Structure of popliteal artery'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0394740', 'cui_str': 'Local anesthetic lateral femoral cutaneous nerve block'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0576094', 'cui_str': 'Knee joint - range of movement'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",200.0,0.219531,"In addition, Group A had lower morphine consumption than both Group C (P < .05) and Group D (P < .01).","[{'ForeName': 'Donghai', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""Department of Orthopaedic Surgery, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Alqwbani', 'Affiliation': ""Department of Orthopaedic Surgery, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Qiuru', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopaedic Surgery, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Ren', 'Initials': 'R', 'LastName': 'Liao', 'Affiliation': ""Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Orthopaedic Surgery, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Pengde', 'Initials': 'P', 'LastName': 'Kang', 'Affiliation': ""Department of Orthopaedic Surgery, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}]",The Journal of arthroplasty,['10.1016/j.arth.2020.06.060'] 837,32687220,Empathy as a buffer: How empathy moderates the emotional effects on Preschoolers' sharing.,"This study experimentally investigated how empathy moderated the influence of external emotional stimuli on preschoolers' subsequent sharing behaviour. Children aged 4-6 (N = 218) were randomly presented with one of the video clips that elicited sad, happy, or neutral emotion, and were then asked to play a dictator game with puppet partners. Results revealed that compared to the neutral condition, children with higher empathy increased sharing after induced happiness but did not change sharing after induced sadness; by contrast, children with lower empathy decreased sharing after induced sadness. It appears that empathy may enhance the positive effect of happiness while reducing the negative effect of sadness on sharing behaviour. These findings provide experimental evidence in early childhood to support approaches that emphasize the role of immediate emotions in moral decision-making; critically, such emotional effects vary with individual differences in dispositional empathy.",2021,"Results revealed that compared to the neutral condition, children with higher empathy increased sharing after induced happiness but did not change sharing after induced sadness; by contrast, children with lower empathy decreased sharing after induced sadness.","['Children aged 4-6 (N\xa0=\xa0218', ""preschoolers' subsequent sharing behaviour""]","['video clips that elicited sad, happy, or neutral emotion, and were then asked to play a dictator game with puppet partners', 'external emotional stimuli']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0034125', 'cui_str': 'Puppets'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]",[],218.0,0.0222539,"Results revealed that compared to the neutral condition, children with higher empathy increased sharing after induced happiness but did not change sharing after induced sadness; by contrast, children with lower empathy decreased sharing after induced sadness.","[{'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Guo', 'Affiliation': 'Department of Psychology, School of Social Sciences, Tsinghua University, Beijing, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Psychology, School of Social Sciences, Tsinghua University, Beijing, China.'}]","British journal of psychology (London, England : 1953)",['10.1111/bjop.12466'] 838,33066130,"Designing an Effective Front-of-Package Warning Label for Food and Drinks High in Added Sugar, Sodium, or Saturated Fat in Colombia: An Online Experiment.","Policies to require warnings on the front of food and drinks high in nutrients of concern (e.g., added sugar, sodium, or saturated fat) are becoming increasingly common as an obesity prevention strategy. Colombia, a country with growing prevalence of obesity, is considering implementing a similar policy. The objective of this study was to assess perceptions and reactions to different warning designs. We conducted a randomized experiment in an online panel of adults age > 18y ( n = 1997). Participants were randomized to view one of four labels: a control label (barcode), an octagon warning, a circle warning, and a triangle warning. Participants viewed their randomly assigned label on a series of products and answered questions (continuous outcomes ranged from 1-4). Compared to the control, all warnings led to higher perceived message effectiveness (increase in mean from 1.79 in the control to 2.59-2.65 in the warning conditions, p < 0.001), a higher percentage of participants who correctly identified products high in nutrients of concern (from 48% in the control condition to 84-89% in the warning conditions, p < 0.001), and reduced intentions to purchases these products (decrease in mean from 2.59 to 1.99-2.01 in the warning conditions, p < 0.001). Relative to the control, warnings performed similarly across education levels, suggesting this policy would be equitable in Colombia. Looking at differences by warning type, the pattern of results suggested that the octagon warnings performed best. After viewing all label types, 49% of participants selected the octagon warning as the one that most discouraged them from consuming products high in nutrients of concern, while 21% and 27% selected the circle and triangle warning. Colombian policymakers should consider the octagon warning as part of a front-of-package labeling policy to help consumers identify and reduce consumption of foods and drinks high in nutrients of concern.",2020,"Compared to the control, all warnings led to higher perceived message effectiveness (increase in mean from 1.79 in the control to 2.59-2.65 in the warning conditions, p < 0.001), a higher percentage of participants who correctly identified products high in nutrients of concern (from 48% in the control condition to 84-89% in the warning conditions, p < 0.001), and reduced intentions to purchases these products (decrease in mean from 2.59 to 1.99-2.01 in the warning conditions, p < 0.001).",['online panel of adults age '],"['control label (barcode), an octagon warning, a circle warning, and a triangle warning']",['message effectiveness'],"[{'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231706', 'cui_str': 'Circling gait'}, {'cui': 'C0205119', 'cui_str': 'Triangular'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0350172,"Compared to the control, all warnings led to higher perceived message effectiveness (increase in mean from 1.79 in the control to 2.59-2.65 in the warning conditions, p < 0.001), a higher percentage of participants who correctly identified products high in nutrients of concern (from 48% in the control condition to 84-89% in the warning conditions, p < 0.001), and reduced intentions to purchases these products (decrease in mean from 2.59 to 1.99-2.01 in the warning conditions, p < 0.001).","[{'ForeName': 'Lindsey Smith', 'Initials': 'LS', 'LastName': 'Taillie', 'Affiliation': 'Carolina Population Center and Department of Nutrition, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC 27599, USA.'}, {'ForeName': 'Marissa G', 'Initials': 'MG', 'LastName': 'Hall', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, Lineberger Comprehensive Cancer Center, Carolina Population Center, University of North Carolina, Chapel Hill, NC 27599, USA.'}, {'ForeName': 'Luis Fernando', 'Initials': 'LF', 'LastName': 'Gómez', 'Affiliation': 'Facultad de Medicina, Pontificia Universidad Javeriana, 110231 Bogotá, Colombia.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Higgins', 'Affiliation': 'Carolina Population Center, University of North Carolina, Chapel Hill, NC 27516, USA.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Bercholz', 'Affiliation': 'Carolina Population Center, University of North Carolina, Chapel Hill, NC 27516, USA.'}, {'ForeName': 'Nandita', 'Initials': 'N', 'LastName': 'Murukutla', 'Affiliation': 'Vital Strategies, New York, NY 27599, USA.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Mora-Plazas', 'Affiliation': 'Departamento de Nutrición Humana, Universidad Nacional de Colombia, 11001 Bogotá, Colombia.'}]",Nutrients,['10.3390/nu12103124'] 839,32671684,"Efficacy of Tiotropium/Olodaterol Compared with Tiotropium as a First-Line Maintenance Treatment in Patients with COPD Who Are Naïve to LAMA, LABA and ICS: Pooled Analysis of Four Clinical Trials.","INTRODUCTION The efficacy of tiotropium/olodaterol compared with tiotropium in patients with chronic obstructive pulmonary disease (COPD) has been demonstrated in a large clinical programme. Currently, randomised controlled trial (RCT) data on dual bronchodilation as first-line maintenance therapy are limited. In this post hoc analysis of pooled data from four RCTs, we compared the efficacy of tiotropium/olodaterol versus tiotropium as maintenance therapy in patients with COPD who were not receiving maintenance treatment with long-acting muscarinic antagonists (LAMAs), long-acting β 2 -agonists (LABAs) or inhaled corticosteroids (ICS) (""maintenance naïve"") at study entry. METHODS TONADO ®  1/2 (52 weeks) and OTEMTO ®  1/2 (12 weeks) were phase III RCTs in patients with COPD. TONADO 1/2 and OTEMTO 1/2 enrolled patients with post-bronchodilator forced expiratory volume in 1 s (FEV 1 ) < 80% predicted (lower limit FEV 1  ≥ 30% in OTEMTO 1/2 only). We examined the effect of tiotropium/olodaterol 5/5 µg versus tiotropium 5 µg on trough FEV 1 response, St. George's Respiratory Questionnaire (SGRQ) total score and Transition Dyspnoea Index (TDI) focal score at 12 weeks in four pooled studies. RESULTS The pooled analysis included 1078 maintenance-naïve patients. There were significant improvements with tiotropium/olodaterol versus tiotropium in trough FEV 1 [0.056 L; 95% confidence interval (CI) 0.033, 0.079; P < 0.0001], SGRQ score (- 1.780; 95% CI - 3.126 to - 0.434; P = 0.0096) and TDI score (0.409; 95% CI 0.077, 0.741; P = 0.0158) at week 12. For patients receiving tiotropium/olodaterol, the odds of achieving a minimal clinically important difference from baseline in any of the analysed outcomes (FEV 1 ≥ 0.1 L, SGRQ ≥ 4.0 points or TDI ≥ 1.0 point) were higher versus tiotropium. CONCLUSIONS In patients who were maintenance naïve at baseline, treatment initiation with tiotropium/olodaterol resulted in greater improvements in lung function, health status and dyspnoea severity compared with tiotropium alone, without compromising patient safety. These results support the use of dual bronchodilation with tiotropium/olodaterol as first-line maintenance treatment in patients with COPD. TRIAL REGISTRATION ClinicalTrials.gov: TONADO ® 1 and 2 (NCT01431274 and NCT01431287, registered 8 September 2011) and OTEMTO ® 1 and 2 (NCT01964352 and NCT02006732, registered 14 October 2013).",2020,"There were significant improvements with tiotropium/olodaterol versus tiotropium in trough FEV 1 [0.056 L; 95% confidence interval (CI) 0.033, 0.079; P < 0.0001], SGRQ score (- 1.780; 95% CI - 3.126 to - 0.434; P = 0.0096) and TDI score (0.409; 95% CI 0.077, 0.741; P = 0.0158) at week 12.","['1078 maintenance-naïve patients', 'patients with COPD', '1/2 enrolled patients with post-bronchodilator forced expiratory volume in 1\xa0s (FEV 1 )\u2009<\u200980% predicted (lower limit FEV 1 \u2009≥\u200930% in OTEMTO\xa01/2 only', 'patients with COPD who were not receiving maintenance treatment with long-acting muscarinic antagonists (LAMAs), long-acting β 2 -agonists (LABAs) or inhaled corticosteroids (ICS) (""maintenance naïve"") at study entry', 'patients with chronic obstructive pulmonary disease (COPD', 'Patients with COPD']","['tiotropium/olodaterol\xa05/5\xa0µg versus tiotropium', 'ICS', 'Tiotropium/Olodaterol', 'tiotropium/olodaterol', 'tiotropium/olodaterol versus tiotropium', 'Tiotropium', 'tiotropium']","['lung function, health status and dyspnoea severity', 'SGRQ score', 'TDI score', ""trough FEV 1 response, St. George's Respiratory Questionnaire (SGRQ) total score and Transition Dyspnoea Index (TDI) focal score""]","[{'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C2934193', 'cui_str': 'olodaterol'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205976', 'cui_str': 'Toluene di-isocyanate-containing product'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205234', 'cui_str': 'Focal'}]",,0.220967,"There were significant improvements with tiotropium/olodaterol versus tiotropium in trough FEV 1 [0.056 L; 95% confidence interval (CI) 0.033, 0.079; P < 0.0001], SGRQ score (- 1.780; 95% CI - 3.126 to - 0.434; P = 0.0096) and TDI score (0.409; 95% CI 0.077, 0.741; P = 0.0158) at week 12.","[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Buhl', 'Affiliation': 'Pulmonary Department, Johannes Gutenberg Universitat Mainz, Mainz, Germany. Roland.Buhl@unimedizin-mainz.de.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'de la Hoz', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Wenqiong', 'Initials': 'W', 'LastName': 'Xue', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Gary T', 'Initials': 'GT', 'LastName': 'Ferguson', 'Affiliation': 'Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA.'}]",Advances in therapy,['10.1007/s12325-020-01411-0'] 840,32673446,Evaluation of the Potential for QTc Prolongation With Repeated Oral Doses of Fedratinib in Patients With Advanced Solid Tumors.,"The impact of repeated daily 500-mg fedratinib (an oral selective Janus kinase [JAK] 2 inhibitor) on QTc and other electrocardiogram (ECG) parameters was assessed in 60 patients with advanced solid tumors. Patients received placebo on day 1 and fedratinib 500 mg daily for 14 days. Concentration-QTc analysis was performed with change-from-baseline QTc corrected by Fridericia's formula (ΔQTcF) as the dependent variable. Fedratinib median time to maximum plasma concentration (C max ) was observed 3 hours postdose on day 15. The largest difference between means for fedratinib and placebo was 0.5 bpm (90%CI, -2.75 to 3.72 bpm) for heart rate (3 hours postdose) and 4.3 milliseconds (90%CI, 1.04-7.60 milliseconds) for QTcF (4 hours postdose). The estimated slope of the fedratinib concentration-QTcF relationship was shallow and not statistically significant: -0.0005 milliseconds per ng/mL (90%CI, -0.00145 to 0.00050 milliseconds per ng/mL). Predicted fedratinib placebo-corrected ΔQTcF was 0.6 milliseconds (90%CI, -1.80 to 2.93 milliseconds) at the geometric mean of the observed C max (3615 ng/mL). Fedratinib did not affect PR or QRS intervals. No patients had QTcF > 60 milliseconds, and no patients experienced QTcF ≥ 500 milliseconds. Fedratinib did not cause clinically relevant ECG effects or QTc prolongation. Safety findings were consistent with the known safety profile.",2021,Fedratinib did not cause clinically relevant ECG effects or QTc prolongation.,"['Patients With Advanced Solid Tumors', '60 patients with advanced solid tumors']","['placebo-corrected ΔQTcF', 'placebo']","['Fedratinib median time to maximum plasma concentration (C max ', 'heart rate', 'QTc and other electrocardiogram (ECG) parameters', 'fedratinib concentration-QTcF relationship', 'PR or QRS intervals']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}]","[{'cui': 'C3886623', 'cui_str': 'Fedratinib'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0520880', 'cui_str': 'QRS interval'}]",60.0,0.275115,Fedratinib did not cause clinically relevant ECG effects or QTc prolongation.,"[{'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Ogasawara', 'Affiliation': 'Bristol Myers Squibb, Summit, New Jersey, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Sanofi, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Yin', 'Affiliation': 'Sanofi, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Borje', 'Initials': 'B', 'LastName': 'Darpo', 'Affiliation': 'ERT, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Carayannopoulos', 'Affiliation': 'Bristol Myers Squibb, Summit, New Jersey, USA.'}, {'ForeName': 'Hongqi', 'Initials': 'H', 'LastName': 'Xue', 'Affiliation': 'ERT, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Palmisano', 'Affiliation': 'Bristol Myers Squibb, Summit, New Jersey, USA.'}, {'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Krishna', 'Affiliation': 'Bristol Myers Squibb, Summit, New Jersey, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.850'] 841,32681453,Probiotics Supplementation on Cardiac Remodeling Following Myocardial Infarction: a Single-Center Double-Blind Clinical Study.,"Adverse cardiac remodeling after myocardial infarction (MI) can lead to the syndrome of heart failure (HF). Recently, changes in gut microbiota composition (dysbiosis) have appeared as a novel candidate that may be linked to the development of CR and HF. The aim of this trial was to evaluate the effects of probiotics administration on attenuating CR in patients with MI. A single-center double-blind placebo-controlled stratified randomized clinical study was conducted in 44 subjects with MI who underwent percutaneous coronary intervention (PCI). Patients were randomly assigned to take, with lunch, either a probiotic capsule containing 1.6 × 10 9 colony-forming unit (CFU) of bacteria (treatment group) or capsules contained inulin (control group) over 3 months. CR biomarkers (including serum procollagen III, transforming growth factor beta (TGF-β), trimethylamine N-oxide (TMAO), and matrix metallopeptidase 9 (MMP-9)) were assessed. Echocardiography results were measured at baseline and after the intervention. Significant decreases were seen in serum TGF-β concentrations (- 8.0 ± 2.1 vs. - 4.01 ± 1.8 pg/mL, p = 0.001) and TMAO levels (- 17.43 ± 10.20 vs. - 4.54 ± 8.7 mmol/L, p = 0.043), and there were no differences were seen in MMP-9 (- 4.1 ± 0.12 vs. - 4.01 + 0.15 nmol/mL, p = 0.443) and procollagen III levels (- 1.35 ± 0.70 vs. 0.01 + 0.3 mg/L, p = 0.392) subsequent to probiotics supplementation compared with the placebo group. Improvements in echocardiographic indices were also greater in the probiotics group as compared with that in the control group, but not at a significant level. Regression analysis revealed that baseline left ventricular ejection fraction (LVEF), and changes of procollagen III, predicted 62% of the final LVEF levels. Probiotics administration may have a beneficial effect on the cardiac remodeling process in patients with myocardial infarction. Iranian Registry of Clinical Trials (IRCT): IRCT20121028011288N15.",2021,Significant decreases were seen in serum,"['patients with MI', 'patients with myocardial infarction', 'Myocardial Infarction', 'Iranian Registry of Clinical Trials (IRCT', '44 subjects with MI who underwent percutaneous coronary intervention (PCI']","['Probiotics', 'Probiotics Supplementation', 'probiotics administration', 'probiotic capsule containing 1.6\u2009×\u200910 9 colony-forming unit (CFU) of bacteria (treatment group) or capsules contained inulin (control group) over 3\xa0months', 'placebo']","['CR biomarkers (including serum procollagen III, transforming growth factor beta (TGF-β), trimethylamine N-oxide (TMAO), and matrix metallopeptidase 9 (MMP-9', 'Cardiac Remodeling', 'serum', 'procollagen III levels', 'baseline left ventricular ejection fraction (LVEF), and changes of procollagen III', 'TGF-β concentrations', 'echocardiographic indices', 'TMAO levels', 'MMP-9']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0040690', 'cui_str': 'Platelet Transforming Growth Factor'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C2736430', 'cui_str': 'Matrix metallopeptidase 9'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",44.0,0.212706,Significant decreases were seen in serum,"[{'ForeName': 'Jalal', 'Initials': 'J', 'LastName': 'Moludi', 'Affiliation': 'School of Nutrition Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran. jmoludi@yahoo.com.'}, {'ForeName': 'Somaieh', 'Initials': 'S', 'LastName': 'Saiedi', 'Affiliation': 'Nutrition Research Center, Faculty of Nutrition, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Ebrahimi', 'Affiliation': 'Maragheh University of Medical Sciences, Maragheh, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Alizadeh', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Sciences, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran. mdalizadeh@gmail.com.'}, {'ForeName': 'Yaser', 'Initials': 'Y', 'LastName': 'Khajebishak', 'Affiliation': 'Maragheh University of Medical Sciences, Maragheh, Iran.'}, {'ForeName': 'Sevda Saleh', 'Initials': 'SS', 'LastName': 'Ghadimi', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Sciences, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Journal of cardiovascular translational research,['10.1007/s12265-020-10052-1'] 842,33067310,Impact of oral corticosteroids on respiratory outcomes in acute preschool wheeze: a randomised clinical trial.,"OBJECTIVE To determine if administration of oral prednisolone to preschool children with acute wheeze alters respiratory outcomes. DESIGN Double-blind, randomised, placebo-controlled equivalence trial. SETTING Three hospitals in New Zealand. PATIENTS 477 children aged 24-59 months with acute wheeze associated with respiratory illness. INTERVENTIONS 2 mg/kg (maximum 40 mg) oral prednisolone or similar placebo, once daily for 3 days. MAIN OUTCOME MEASURES Primary outcome was change in Preschool Respiratory Assessment Measure (PRAM) score 24 hours after intervention. Secondary outcomes included PRAM score at 4 hours, length of emergency department and inpatient stays, admission and representation rates, time to return to normal activities and use of additional oral prednisolone or intravenous medications. Analysis was by intention-to-treat. RESULTS There was no difference between groups for change in PRAM score at 24 hours (difference between means -0.39, 95% CI -0.84 to 0.06, p=0.09). Absolute PRAM score was lower in the prednisolone group at 4 hours (median (IQR) 1 (0-2) vs 2 (0-3), p=0.01) and 24 hours (0 (0-1) vs 0 (0-1), p=0.01), when symptoms had resolved for most children regardless of initial treatment. Admission rate, requirement for additional oral prednisolone and use of intravenous medication were lower in the prednisolone group, although there were no differences between groups for time taken to return to normal activities or rates of representation within 7 days. CONCLUSION Oral prednisolone does not alter respiratory outcomes at 24 hours or beyond in preschool children presenting with acute wheeze.",2021,"CONCLUSION Oral prednisolone does not alter respiratory outcomes at 24 hours or beyond in preschool children presenting with acute wheeze.","['acute preschool wheeze', 'Three hospitals in New Zealand', 'preschool children presenting with acute wheeze', 'preschool children with acute wheeze alters respiratory outcomes', '477 children aged 24-59 months with acute wheeze associated with respiratory illness']","['oral corticosteroids', 'placebo', 'oral prednisolone or similar placebo', 'prednisolone', 'oral prednisolone']","['PRAM score at 4 hours, length of emergency department and inpatient stays, admission and representation rates, time to return to normal activities and use of additional oral prednisolone or intravenous medications', 'respiratory outcomes', 'time taken to return to normal activities or rates of representation', 'change in Preschool Respiratory Assessment Measure (PRAM) score', 'Absolute PRAM score', 'Admission rate, requirement for additional oral prednisolone and use of intravenous medication', 'PRAM score']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0358513', 'cui_str': 'Prednisolone-containing product in oral dose form'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}]","[{'cui': 'C0549075', 'cui_str': 'Respiratory assessment'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1292426', 'cui_str': '4 hours'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0420512', 'cui_str': 'Inpatient stay'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0358513', 'cui_str': 'Prednisolone-containing product in oral dose form'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}]",477.0,0.727444,"CONCLUSION Oral prednisolone does not alter respiratory outcomes at 24 hours or beyond in preschool children presenting with acute wheeze.","[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Wallace', 'Affiliation': 'Department of Paediatrics, Waikato Hospital, Hamilton, New Zealand.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Sinclair', 'Affiliation': 'Department of Paediatrics: Child and Youth Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Shepherd', 'Affiliation': 'Department of Paediatrics: Child and Youth Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Neutze', 'Affiliation': 'Department of Paediatrics: Child and Youth Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Trenholme', 'Affiliation': 'Department of Paediatrics: Child and Youth Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Eunicia', 'Initials': 'E', 'LastName': 'Tan', 'Affiliation': 'Emergency Department, Middlemore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Brabyn', 'Affiliation': 'Emergency Department, Waikato Hospital, Hamilton, New Zealand.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Bonisch', 'Affiliation': ""Children's Emergency Department, Starship Children's Health, Auckland, New Zealand.""}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Grey', 'Affiliation': 'Department of Paediatrics: Child and Youth Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Johnson', 'Affiliation': 'Departments of Paediatrics, Emergency Medicine, and Pharmacology and Physiology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'McNamara', 'Affiliation': 'Department of Paediatrics: Child and Youth Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'John M D', 'Initials': 'JMD', 'LastName': 'Thompson', 'Affiliation': 'Department of Paediatrics: Child and Youth Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Innes', 'Initials': 'I', 'LastName': 'Asher', 'Affiliation': 'Department of Paediatrics: Child and Youth Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Stuart R', 'Initials': 'SR', 'LastName': 'Dalziel', 'Affiliation': 'Department of Paediatrics: Child and Youth Health, The University of Auckland, Auckland, New Zealand s.dalziel@auckland.ac.nz.'}]",Archives of disease in childhood,['10.1136/archdischild-2020-318971'] 843,33074283,Association of Medicaid-Focused or Commercial Medicaid Managed Care Plan Type With Outpatient and Acute Care.,"Importance Enrollment in Medicaid managed care plans has increased rapidly, particularly in national commercial insurance plans. Whether the type of managed care plan is associated with the use of health services for Medicaid beneficiaries is unknown. Objective To compare the use of outpatient and acute care between Medicaid enrollees randomly assigned to a national commercial managed care plan or a local Medicaid-focused managed care plan. Design, Setting, and Participants This natural experiment of a cohort of Medicaid enrollees randomly assigned to 2 managed care plans in a Northeastern US state was conducted from June 30, 2009, to June 30, 2013. Statistical analysis was performed from September 1, 2019, to August 30, 2020. Interventions Assignment to a Medicaid-focused insurance plan or a commercial managed care plan. Main Outcomes and Measures Outpatient visits, emergency department visits, and total inpatient and ambulatory care-sensitive hospitalizations. Results A total of 8010 patients were included in the analysis: 4737 were assigned to a Medicaid-focused plan (2795 female [59.0%]; mean [SD] age, 17.8 [3.2] years) and 3273 to a commercial managed care plan (1915 female [58.5%]; mean [SD] age, 17.9 [3.3] years). Those randomly assigned to the Medicaid-focused plan had a mean (SD) of 6.67 (9.18) annual outpatient visits per person, and those assigned to the commercial plan had a mean (SD) of 8.36 (11.77) annual outpatient visits per person (adjusted absolute difference, 1.72 [95% CI, 1.31-2.13]; 22% relative difference). The increased use of outpatient visits in the commercial plan was associated with an increase in specialty care visits (mean [SD], 2.34 [6.31] visits in Medicaid-focused plan vs 3.75 [9.32] visits in commerical plan; adjusted absolute difference, 1.43 visits [95% CI, 1.25-1.56 visits]; 61% relative difference). Mean (SD) annual emergency department visits were 0.49 (1.39) per person in the Medicaid-focused plan and 0.51 (1.40) in the commercial plan (adjusted absolute difference, 0.02 [95% CI, -0.02 to 0.05]). Mean (SD) annual inpatient admissions were 0.067 (0.45) per person in the Medicaid-focused plan and 0.069 (0.53) in the commercial plan (adjusted absolute difference, 0.003 [95% CI, -0.01 to 0.02]). Plan assignment was not significantly associated with ambulatory care-sensitive admissions. Results were consistent in instrumental variables analyses that accounted for disenrollment and switching. Conclusions and Relevance Compared with Medicaid managed care enrollees assigned to a Medicaid-focused plan, those assigned to a commercial plan had more outpatient visits, particularly for specialty care, but had similar rates of emergency department visits and hospitalizations. These findings suggest that the type of managed care plan may be associated with health services use and spending among Medicaid beneficiaries and that random assignment may help states understand how well different plans perform for enrollees.",2020,"The increased use of outpatient visits in the commercial plan was associated with an increase in specialty care visits (mean [SD], 2.34","['mean [SD] age, 17.8 [3.2] years) and 3273 to a commercial managed care plan (1915 female [58.5%]; mean [SD] age, 17.9 [3.3] years', 'A total of 8010 patients were included in the analysis: 4737 were assigned to a Medicaid-focused plan (2795 female [59.0', 'cohort of Medicaid enrollees randomly assigned to 2 managed care plans in a Northeastern US state was conducted from June 30, 2009, to June 30, 2013']","['national commercial managed care plan or a local Medicaid-focused managed care plan', 'Medicaid-focused insurance plan or a commercial managed care plan']","['Mean (SD) annual inpatient admissions', 'specialty care visits', 'Mean (SD) annual emergency department visits', 'Measures\n\n\nOutpatient visits, emergency department visits, and total inpatient and ambulatory care-sensitive hospitalizations']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086583', 'cui_str': 'Managed Care'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517688', 'cui_str': '3.3'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0086583', 'cui_str': 'Managed Care'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",8010.0,0.0869955,"The increased use of outpatient visits in the commercial plan was associated with an increase in specialty care visits (mean [SD], 2.34","[{'ForeName': 'Shailender', 'Initials': 'S', 'LastName': 'Swaminathan', 'Affiliation': 'Leveraging Evidence for Access and Development, Krea University, Sricity, India.'}, {'ForeName': 'Chima D', 'Initials': 'CD', 'LastName': 'Ndumele', 'Affiliation': 'Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Gordon', 'Affiliation': 'Department of Health Law, Policy, and Management, Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Yoojin', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Department of Health Services, Policy and Practice, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Amal N', 'Initials': 'AN', 'LastName': 'Trivedi', 'Affiliation': 'Department of Health Services, Policy and Practice, Brown University, Providence, Rhode Island.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.5408'] 844,33070152,"""Fenofibrate as an adjuvant to phototherapy in pathological unconjugated hyperbilirubinemia in neonates: a randomized control trial.""","BACKGROUND Despite widespread phototherapy usage, many new-born infants remain in need of other invasive lines of therapy, such as intravenous immunoglobulins and exchange transfusions. OBJECTIVE Assessment of the efficacy and the safety of adding fenofibrate to phototherapy for the treatment of pathological jaundice in full-term infants. DESIGN/METHODS We conducted a double blinded randomized control study on 180 full-term infants with pathological unconjugated hyperbilirubinemia admitted to the NICU at Mansoura University Children's Hospital. They were randomly assigned to receive either oral fenofibrate 10 mg/kg/day for 1 day or 2 days or placebo in addition to phototherapy. The primary outcome was total serum bilirubin values after 12, 24, 36, 48, and 72 h from intervention. Secondary outcomes were total duration of treatment, need for exchange transfusions and intravenous immunoglobulin, exclusive breast-feeding on discharge, and adverse effects of fenofibrate. This study was registered at www.clinicaltrials.gov (NCT04418180). RESULTS A total of 180 full-term infants were included, 60 in each group. Infants in group I and II showed significant reduction of bilirubin levels at 36, 48, and 72 h from intervention compared to group III, respectively. Fenofibrate administration was associated with significantly shorter duration of phototherapy, shorter hospital stay, and higher frequency of exclusive breast-feeding compared to phototherapy alone. CONCLUSION(S) Fenofibrate as an adjuvant to phototherapy in term neonate with pathological jaundice is well tolerated and associated with significant reduction of serum bilirubin levels, a shorter duration of phototherapy, shorter hospital stay and higher frequency of exclusive breast-feeding, without significant adverse effects in either the single or double dosage.",2021,"I and II showed significant reduction of bilirubin levels at 36, 48, and 72 h from intervention compared to group III, respectively.","[""180 full-term infants with pathological unconjugated hyperbilirubinemia admitted to the NICU at Mansoura University Children's Hospital"", 'pathological jaundice in full-term infants', 'A total of 180 full-term infants were included, 60 in each group', 'pathological unconjugated hyperbilirubinemia in neonates']","['Fenofibrate', 'fenofibrate to phototherapy', 'placebo', 'oral fenofibrate']","['shorter duration of phototherapy, shorter hospital stay, and higher frequency of exclusive breast-feeding', 'total duration of treatment, need for exchange transfusions and intravenous immunoglobulin, exclusive breast-feeding on discharge, and adverse effects of fenofibrate', 'bilirubin levels', 'total serum bilirubin values', 'serum bilirubin levels']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C4551581', 'cui_str': 'Term baby'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0268306', 'cui_str': 'Unconjugated hyperbilirubinemia'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0022346', 'cui_str': 'Jaundice'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}]","[{'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0015236', 'cui_str': 'Exchange transfusion'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C0344395', 'cui_str': 'Bilirubin measurement'}, {'cui': 'C1278039', 'cui_str': 'Serum total bilirubin measurement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0428441', 'cui_str': 'Serum bilirubin measurement'}]",180.0,0.341387,"I and II showed significant reduction of bilirubin levels at 36, 48, and 72 h from intervention compared to group III, respectively.","[{'ForeName': 'Mohammad Hosny', 'Initials': 'MH', 'LastName': 'Awad', 'Affiliation': ""Department of pediatrics, Mansoura University Children's Hospital, Mansoura, Egypt. mo7amed_hosny@hotmail.com.""}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Amer', 'Affiliation': 'Department of pediatrics, Insurance Hospital, Ministry of health, Mansoura, Egypt.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Hafez', 'Affiliation': ""Department of pediatrics, Mansoura University Children's Hospital, Mansoura, Egypt.""}, {'ForeName': 'Islam', 'Initials': 'I', 'LastName': 'Nour', 'Affiliation': ""Department of pediatrics, Mansoura University Children's Hospital, Mansoura, Egypt.""}, {'ForeName': 'AbdElaziz', 'Initials': 'A', 'LastName': 'Shabaan', 'Affiliation': ""Department of pediatrics, Mansoura University Children's Hospital, Mansoura, Egypt.""}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-00861-2'] 845,33070154,"The effects of inhibition of fatty acid amide hydrolase (FAAH) by JNJ-42165279 in social anxiety disorder: a double-blind, randomized, placebo-controlled proof-of-concept study.","JNJ-42165279 is a selective inhibitor of fatty acid amide hydrolase (FAAH), the enzyme responsible for the degradation of fatty acid amides (FAA) including anandamide (AEA), palmitoylethanolamide (PEA), and N-oleoylethanolamide (OEA). We assessed the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of treatment with JNJ-42165279 in subjects with social anxiety disorder (SAD). This was a multicenter, double-blind, placebo-controlled study randomizing subjects to 12 weeks of treatment with either JNJ-42165279 (25 mg daily) or placebo (PBO). The primary endpoint was the change in the Liebowitz Social Anxiety Scale (LSAS) total score from baseline to end of study. Secondary endpoints included the Hamilton Anxiety Scale (HAM-A), Hamilton Depression Rating Scale (HDRS 17 ), and the Clinical Global Impression-Improvement (CGI-I). Samples were collected for plasma concentration of AEA, PEA, OEA, and JNJ-42165279. A total of 149 subjects were enrolled with a mean baseline LSAS total score of 102.6 (SD 16.84). The mean change from baseline (SD) in LSAS total score at week 12 was numerically greater for JNJ-42165279: -29.4 (27.47) compared to PBO: -22.4 (23.57) but not significant. The percentage of subjects with ≥30% improvement from baseline in the LSAS total score was significantly higher for JNJ-42165279 (42.4%) compared to PBO (23.6%) (p value = 0.04). The percentage of subjects with a CGI-I score of much or very much improved was also significantly higher for JNJ-42165279 (44.1%) than for PBO (23.6%) (p value = 0.02). The drug was well tolerated. JNJ-42165279 appears to elicit an anxiolytic effect in subjects with SAD although trough concentrations with 25 mg once daily appeared to be insufficient to completely inhibit FAAH activity which may have led to suboptimal efficacy. ClinicalTrials.gov Identifier: NCT02432703.",2021,The percentage of subjects with ≥30% improvement from baseline in the LSAS total score was significantly higher for JNJ-42165279 (42.4%) compared to PBO (23.6%) (p value = 0.04).,"['A total of 149 subjects were enrolled with a mean baseline LSAS total score of 102.6 (SD 16.84', 'social anxiety disorder', 'subjects with social anxiety disorder (SAD', 'subjects with SAD']","['placebo', 'JNJ-42165279', 'fatty acid amide hydrolase (FAAH', 'placebo (PBO']","['Liebowitz Social Anxiety Scale (LSAS) total score', 'anxiolytic effect', 'efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics', 'tolerated', 'plasma concentration of AEA, PEA, OEA, and JNJ-42165279', 'LSAS total score', 'Hamilton Anxiety Scale (HAM-A), Hamilton Depression Rating Scale (HDRS 17 ), and the Clinical Global Impression-Improvement (CGI-I', 'mean change from baseline (SD) in LSAS total score']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C5139852', 'cui_str': 'JNJ-42165279'}, {'cui': 'C0531004', 'cui_str': 'fatty acid amide hydrolase'}]","[{'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3179404', 'cui_str': 'Anti-Anxiety Effects'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002482', 'cui_str': 'Amide'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0211726', 'cui_str': 'anandamide'}, {'cui': 'C0069964', 'cui_str': 'palmidrol'}, {'cui': 'C1454896', 'cui_str': 'oleoylethanolamide'}, {'cui': 'C5139852', 'cui_str': 'JNJ-42165279'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C1840333', 'cui_str': 'Hypoparathyroidism, deafness, renal disease syndrome'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",149.0,0.0684413,The percentage of subjects with ≥30% improvement from baseline in the LSAS total score was significantly higher for JNJ-42165279 (42.4%) compared to PBO (23.6%) (p value = 0.04).,"[{'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Schmidt', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium. mschmid4@its.jnj.com.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Liebowitz', 'Affiliation': 'The Medical Research Network, New York, NY, USA.'}, {'ForeName': 'Murray B', 'Initials': 'MB', 'LastName': 'Stein', 'Affiliation': 'University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Grunfeld', 'Affiliation': 'Peninsula Therapeutic & Research Group, Frankston, VIC, Australia.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Van Hove', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'W Kyle', 'Initials': 'WK', 'LastName': 'Simmons', 'Affiliation': 'Janssen Research & Development, La Jolla, CA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Van Der Ark', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Palmer', 'Affiliation': 'Janssen Research & Development, La Jolla, CA, USA.'}, {'ForeName': 'Ziad S', 'Initials': 'ZS', 'LastName': 'Saad', 'Affiliation': 'Janssen Research & Development, La Jolla, CA, USA.'}, {'ForeName': 'Darrel J', 'Initials': 'DJ', 'LastName': 'Pemberton', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Van Nueten', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Wayne C', 'Initials': 'WC', 'LastName': 'Drevets', 'Affiliation': 'Janssen Research & Development, La Jolla, CA, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00888-1'] 846,33078479,Prescription Medication Use in Older Adults Without Major Cardiovascular Disease Enrolled in the Aspirin in Reducing Events in the Elderly (ASPREE) Clinical Trial.,"BACKGROUND Efforts to minimize medication risks among older adults include avoidance of potentially inappropriate medications. Contemporary analysis of medication use in community-dwelling older people compared with the general population is lacking. PARTICIPANTS A total of 19,114 community-dwelling adults in Australia and the United States aged 70 years or older (65 years or older for U.S. minorities) without histories of major cardiovascular disease, cognitive impairment, or disability participated in a randomized, placebo-controlled trial of aspirin: ASPirin in Reducing Events in the Elderly study. Measurements Prescribed baseline medications obtained by self-report and medical record review were grouped by World Health Organization Anatomic and Therapeutic Chemical category. Potentially inappropriate medications were defined using a modified American Geriatrics Society Beers Criteria. Polypharmacy was defined as 5 or more medications, and hyperpolypharmacy defined as 10 or more medications. Cross-sectional descriptive statistics and adjusted odds ratios were computed. RESULTS The median number of prescription medications per participant was three, regardless of age. Women had a higher medication prevalence. Cardiovascular drugs (primarily antihypertensives) were the most commonly reported (64%). Overall, 39% of the cohort reported taking at least one potentially inappropriate medication, with proton-pump inhibitors being the most commonly reported (21.2% of cohort). Of the cohort, 27% had polypharmacy, and 2% hyperpolypharmacy. Age 75 years or older, less than 12 years of education, hypertension, diabetes mellitus, chronic kidney disease, frailty, gastrointestinal complaint, and depressive symptoms were associated with an increased likelihood of potentially inappropriate medications and polypharmacy. For almost all medication classes, prevalence was equivalent or lower than the general older population. CONCLUSION Overall medication burden and polypharmacy are low in older adults free of major cardiovascular disease, disability, and cognitive impairment. The prevalence of potentially inappropriate medications is higher than previously reported and similar to more vulnerable populations as a result of the introduction of proton-pump inhibitors to the American Geriatrics Society Beers Criteria. Longitudinal follow-up is required to further understand the balance of benefits and risks for potentially inappropriate medications and polypharmacy in community-dwelling older people.",2020,Women had a higher medication prevalence.,"['older adults', 'A total of 19,114 community-dwelling adults in Australia and the United States aged 70\xa0years or older (65 years or older for U.S. minorities) without histories of major cardiovascular disease, cognitive impairment, or disability participated in a randomized', 'community-dwelling older people', 'Age\xa075\xa0years or older, less than 12\xa0years of education, hypertension, diabetes mellitus, chronic kidney disease, frailty, gastrointestinal complaint, and depressive symptoms were associated with an increased likelihood of potentially inappropriate medications and polypharmacy', 'Older Adults Without Major Cardiovascular Disease']","['Aspirin', 'placebo', 'aspirin: ASPirin']","['Elderly (ASPREE', 'median number of prescription medications']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",19114.0,0.072949,Women had a higher medication prevalence.,"[{'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Lockery', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Ernst', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, The University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Broder', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Suzanne G', 'Initials': 'SG', 'LastName': 'Orchard', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Murray', 'Affiliation': 'Hennepin Healthcare Research Institute, Hennepin Healthcare, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Nigel P', 'Initials': 'NP', 'LastName': 'Stocks', 'Affiliation': 'Discipline of General Practice, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Liew', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Woods', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pharmacotherapy,['10.1002/phar.2461'] 847,33075197,Sinecatechins ointment as a potential novel treatment for usual type vulval intraepithelial neoplasia: a single-centre double-blind randomised control study.,"OBJECTIVE To compare the safety and efficacy of 10% sinecatechins (Veregen ® ) ointment against placebo in the treatment of usual type vulvar intraepithelial neoplasia (uVIN). DESIGN A Phase II double-blind randomised control trial. SETTING A tertiary gynaecological oncology referral centre. POPULATION All women diagnosed with primary and recurrent uVIN. METHODS Eligible patients were randomised 1:1 to receive either sinecatechins or placebo ointment (applied three times daily for 16 weeks) and were followed up at 2, 4, 8, 16, 32 and 52 weeks. MAIN OUTCOME MEASURES The primary outcome measure, recorded at 16 and 32 weeks, was histological response (HR). Secondary outcome measures included clinical (CR) response, toxicity, quality of life and pain scores. RESULTS There was no observed difference in HR between the two arms. However, of the 26 patients who were randomised, all 13 patients who received sinecatechins showed either complete (n = 5) or partial (n = 8) CR, when best CR was evaluated. In placebo group, three patients had complete CR, two had partial CR, six had stable disease and two were lost to follow up. Patients in the sinecatechins group showed a statistically significant improvement in best observed CR as compared with the placebo group (P = 0.002). There was no difference in toxicity reported in either group. CONCLUSION Although we did not observe a difference in HR between the two treatment arms, we found that 10% sinecatechins application is safe and shows promise in inducing clinical resolution of uVIN lesions and symptom improvement, thus warranting further investigation in a larger multicentre study. TWEETABLE ABSTRACT A randomised control study indicating that sinecatechins ointment may be a novel treatment for uVIN.",2021,Patients in the sinecatechins group showed a statistically significant improvement in best observed CR as compared to the placebo group (P=0.002).,"['usual type vulval intraepithelial neoplasia', 'Eligible patients', '26 patients who were randomised, all 13 patients who received sinecatechins showed either complete (n=5) or partial (n=8) CR', 'usual type vulvar intraepithelial neoplasia (uVIN', 'All women diagnosed with primary and recurrent uVIN', 'A tertiary gynaecological oncology referral center']","['10% sinecatechins (Veregen®) ointment against placebo', 'placebo', 'Sinecatechins ointment', 'sinecatechins or placebo ointment']","['HR', 'safety and efficacy', 'histological response (HR', 'clinical (CR) response, toxicity, quality of life and pain scores', 'CR', 'toxicity']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0346210', 'cui_str': 'Dysplasia of vulva'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960121', 'cui_str': 'Sinecatechins'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0495107', 'cui_str': 'Vulval intraepithelial neoplasia grade 2'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C1321164', 'cui_str': 'Gynecological oncology'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C1960121', 'cui_str': 'Sinecatechins'}, {'cui': 'C1816306', 'cui_str': 'Veregen'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.68127,Patients in the sinecatechins group showed a statistically significant improvement in best observed CR as compared to the placebo group (P=0.002).,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Yap', 'Affiliation': 'Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Slade', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Goddard', 'Affiliation': 'Pan Birmingham Gynaecological Cancer Centre, City Hospital, Birmingham, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Dawson', 'Affiliation': 'Department of Microbiology & Infection, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ganesan', 'Affiliation': ""Department of Histopathology, Birmingham Women's NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Velangi', 'Affiliation': 'Department of Dermatology, Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Sahu', 'Affiliation': 'Department of Obstetrics and Gynaecology, The Shrewsbury and Telford Hospital NHS Trust, Shrewsbury, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Kaur', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hughes', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Luesley', 'Affiliation': 'Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16574'] 848,32671449,Effect of Tumescent Lidocaine and Epinephrine Infiltration on Blood Loss in Inferior Pedicle Wise-Pattern Breast Reduction: A Prospective Randomized Study.,"The idea of infiltrating epinephrine-containing solution in reduction mammoplasty with the aim of reducing blood loss dates back to 1985. Although its use is fairly common among surgeons, scientific evidence supporting such use has been feeble and inconsistent. Therefore, we aimed to investigate the effects of tumescent infiltration of lidocaine- and epinephrine-containing solution on blood loss in reduction mammoplasty. A prospective, randomized, double-blinded study is planned. Forty patients admitted to our clinic for mammary hypertrophy are randomly assigned to experiment and control groups, each of a size of 20 patients. Control group underwent conventional Wise-pattern, inferior pedicle breast reduction, whereas experiment group received tumescent fluid infiltration 20 min prior to making of the incisions. Data including age, body mass index (BMI), comorbidities, operative time, length of hospitalization along with preoperative, postoperative 2nd and 12th hour complete blood counts are recorded for each patient and compared between groups. Data analysis showed no significant difference between groups in terms of age, BMI, comorbidities or preoperative hematocrit levels. Operative time and hospitalization were significantly shorter in experiment group (p < 0.05*). The drop in hematocrit level in both the 2nd (4.93 ± 2.44% to 15.53 ± 7.17%) and 12th hour (9.4 ± 6.79 compared to 21.28 ± 10.15) was lower in the experiment group (p < 0.01*). A multiple variate analysis incorporating preoperative, postoperative 2nd and 12th hour hematocrit levels demonstrated a significant reduction in blood loss with the use of tumescent infiltration (Wilks' lambda F = 12.84, p < 0.01*). Multiple regression analysis revealed age, BMI, comorbidities, preoperative hematocrit levels and hospitalization did not affect postoperative blood loss (p > 0.05). Duration of operation, however, seemed to affect amount of blood loss postoperatively (p < 0.05*). With outcomes obtained from this study, it is clearly shown that tumescent infiltration significantly reduces blood loss in Wise-pattern, inferior pedicle breast reduction. Furthermore, tumescent infiltration is also shown to decrease operative time and length of hospital stay. EBM LEVEL II: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .",2021,Operative time and hospitalization were significantly shorter in experiment group (p < 0.05*).,"['Forty patients admitted to our clinic for mammary hypertrophy', 'Inferior Pedicle Wise-Pattern Breast Reduction']","['lidocaine- and epinephrine-containing solution', 'epinephrine-containing solution', 'conventional Wise-pattern, inferior pedicle breast reduction, whereas experiment group received tumescent fluid infiltration 20\xa0min prior to making of the incisions', 'Tumescent Lidocaine and Epinephrine Infiltration']","['age, body mass index (BMI), comorbidities, operative time, length of hospitalization along with preoperative, postoperative 2nd and 12th hour complete blood counts', 'BMI, comorbidities, preoperative hematocrit levels and hospitalization', 'hematocrit level', 'operative time and length of hospital stay', 'age, BMI, comorbidities or preoperative hematocrit levels', 'postoperative blood loss', 'blood loss', 'Blood Loss', 'Operative time and hospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0020565', 'cui_str': 'Hypertrophy of breast'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0456605', 'cui_str': 'Pedicle'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0191922', 'cui_str': 'Reduction mammoplasty'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0456605', 'cui_str': 'Pedicle'}, {'cui': 'C0191922', 'cui_str': 'Reduction mammoplasty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0184898', 'cui_str': 'Incision'}]","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0009555', 'cui_str': 'Complete blood count'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",40.0,0.0504864,Operative time and hospitalization were significantly shorter in experiment group (p < 0.05*).,"[{'ForeName': 'Alper Burak', 'Initials': 'AB', 'LastName': 'Uslu', 'Affiliation': 'Department of Plastic, Reconstructive and Aesthetic Surgery, Karaman State Hospital, Universite Mahallesi 1984 Str. Number 1, 70200, Karaman, Turkey. dr.alperburakuslu@hotmail.com.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01859-z'] 849,33066081,Leukocyte Activation and Antioxidative Defense Are Interrelated and Moderately Modified by n-3 Polyunsaturated Fatty Acid-Enriched Eggs Consumption-Double-Blind Controlled Randomized Clinical Study.,"This placebo-controlled, double-blind, randomized, interventional study investigated the effects of low/intermediate doses of n-3 polyunsaturated fatty acids (PUFAs) on the endothelial function, markers of leukocyte activation, and oxidative status following dietary intake of n-3 PUFA-enriched hen eggs in young healthy individuals. Twenty young healthy adults of both sexes who consumed n-3 PUFA-enriched hen eggs (two eggs per day, for three weeks, total of approximately 407 mg/day n-3 PUFAs) or regular eggs (two eggs per day for three weeks, total of approximately 75 mg/day n-3 PUFAs) participated in this study. Skin microvascular endothelium-independent and endothelium-dependent vasodilation were assessed by laser Doppler flowmetry. Serum lipid profile and content of free fatty acids, markers of leukocyte activation, biochemical parameters of oxidative stress, as well as antioxidative enzymes serum activity were measured before and after respective dietary protocol. The results of this study revealed significant differences in the markers of leukocyte activation (such as CD11a/LFA-1) and antioxidative defense, which are related to increased intake of n-3 PUFAs, providing the evidence that consumption of nutritionally enriched hen eggs may affect physiological processes related to oxidative balance. The absence of significant changes in microvascular reactivity following supplementation with a low-intermediate dose of n-3 PUFAs, unlike in our previous studies where functional eggs contained ~1 g of n-3 PUFA, suggests the existence of a dose-dependent effect.",2020,"Serum lipid profile and content of free fatty acids, markers of leukocyte activation, biochemical parameters of oxidative stress, as well as antioxidative enzymes serum activity were measured before and after respective dietary protocol.","['young healthy individuals', 'Twenty young healthy adults of both sexes who consumed n-3 PUFA-enriched hen eggs (two eggs per day, for three weeks, total of approximately 407 mg/day n-3 PUFAs) or regular eggs (two eggs per day for three weeks, total of approximately 75 mg/day n-3 PUFAs) participated in this study']","['n-3 PUFA-enriched hen eggs', 'n-3 polyunsaturated fatty acids (PUFAs', 'placebo']","['endothelial function, markers of leukocyte activation, and oxidative status', 'Skin microvascular endothelium-independent and endothelium-dependent vasodilation', 'Serum lipid profile and content of free fatty acids, markers of leukocyte activation, biochemical parameters of oxidative stress, as well as antioxidative enzymes serum activity', 'microvascular reactivity']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0440466', 'cui_str': ""Hen's egg""}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C4082109', 'cui_str': 'Three weeks'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0440466', 'cui_str': ""Hen's egg""}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",20.0,0.195935,"Serum lipid profile and content of free fatty acids, markers of leukocyte activation, biochemical parameters of oxidative stress, as well as antioxidative enzymes serum activity were measured before and after respective dietary protocol.","[{'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Mihalj', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Stupin', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Nikolina', 'Initials': 'N', 'LastName': 'Kolobarić', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Ivana Tartaro', 'Initials': 'IT', 'LastName': 'Bujak', 'Affiliation': 'Radiation Chemistry and Dosimetry Laboratory, Division of Materials Chemistry, IRB, 10000 Zagreb, Croatia.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Matić', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Zlata', 'Initials': 'Z', 'LastName': 'Kralik', 'Affiliation': 'Department of Animal Production and Biotechnology, Faculty of Agrobiotechnical Sciences, Vladimira Preloga 1, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Jukić', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Stupin', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Drenjančević', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}]",Nutrients,['10.3390/nu12103122'] 850,33066107,Effects of Bifidobacterium animalis Subsp. lactis (BPL1) Supplementation in Children and Adolescents with Prader-Willi Syndrome: A Randomized Crossover Trial.,"Prader-Willi syndrome (PWS) is a rare genetic disorder characterized by a wide range of clinical manifestations, including obesity, hyperphagia, and behavioral problems. Bifidobacterium animalis subsp. lactis strain BPL1 has been shown to improve central adiposity in adults with simple obesity. To evaluate BPL1's effects in children with PWS, we performed a randomized crossover trial among 39 patients (mean age 10.4 years). Participants were randomized to placebo-BPL1 ( n = 19) or BPL1-placebo ( n = 20) sequences and underwent a 12-week period with placebo/BPL1 treatments, a 12-week washout period, and a 12-week period with the crossover treatment. Thirty-five subjects completed the study. The main outcome was changes in adiposity, measured by dual-energy X-ray absorptiometry. Secondary outcomes included lipid and glucose metabolism, hyperphagia, and mental health symptoms. Generalized linear modeling was applied to assess differences between treatments. While BPL1 did not modify total fat mass compared to placebo, BPL1 decreased abdominal adiposity in a subgroup of patients older than 4.5 years ( n = 28). BPL1 improved fasting insulin concentration and insulin sensitivity. Furthermore, we observed modest improvements in some mental health symptoms. A follow-up trial with a longer treatment period is warranted to determine whether BPL1 supplementation can provide a long-term therapeutic approach for children with PWS (ClinicalTrials.gov NCT03548480).",2020,"While BPL1 did not modify total fat mass compared to placebo, BPL1 decreased abdominal adiposity in a subgroup of patients older than 4.5 years ( n = 28).","['Children and Adolescents with Prader-Willi Syndrome', 'children with PWS', '39 patients (mean age 10.4 years', 'adults with simple obesity', 'Thirty-five subjects completed the study']","['lactis strain', 'BPL1-placebo', 'lactis (BPL1) Supplementation', 'placebo/BPL1 treatments', 'placebo-BPL1', 'BPL1', 'placebo, BPL1', 'BPL1 supplementation']","['fasting insulin concentration and insulin sensitivity', 'abdominal adiposity', 'total fat mass', 'lipid and glucose metabolism, hyperphagia, and mental health symptoms', 'mental health symptoms', 'central adiposity', 'changes in adiposity, measured by dual-energy X-ray absorptiometry']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0032897', 'cui_str': 'Prader-Willi syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191376', 'cui_str': '10.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0451819', 'cui_str': 'Simple obesity'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0020505', 'cui_str': 'Overeating'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4551560', 'cui_str': 'Central obesity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}]",39.0,0.241297,"While BPL1 did not modify total fat mass compared to placebo, BPL1 decreased abdominal adiposity in a subgroup of patients older than 4.5 years ( n = 28).","[{'ForeName': 'Montse', 'Initials': 'M', 'LastName': 'Amat-Bou', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, 08950 Barcelona, Spain.'}, {'ForeName': 'Sonika', 'Initials': 'S', 'LastName': 'Garcia-Ribera', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, 08950 Barcelona, Spain.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Climent', 'Affiliation': 'Archer Daniels Midland Co-Biopolis, 46980 Valencia, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Piquer-Garcia', 'Affiliation': 'Department of Endocrinology and Nutrition, Germans Trias i Pujol Research Institute, 08916 Barcelona, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Corripio', 'Affiliation': ""Service of Pediatric Endocrinology, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT, Universitat Autònoma de Barcelona, 08208 Sabadell, Spain.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sanchez-Infantes', 'Affiliation': 'Department of Endocrinology and Nutrition, Germans Trias i Pujol Research Institute, 08916 Barcelona, Spain.'}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Villalta', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, 08950 Barcelona, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Elias', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, 08950 Barcelona, Spain.'}, {'ForeName': 'Josep C', 'Initials': 'JC', 'LastName': 'Jiménez-Chillarón', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, 08950 Barcelona, Spain.'}, {'ForeName': 'Empar', 'Initials': 'E', 'LastName': 'Chenoll', 'Affiliation': 'Archer Daniels Midland Co-Biopolis, 46980 Valencia, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ramón', 'Affiliation': 'Archer Daniels Midland Co-Biopolis, 46980 Valencia, Spain.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Ibañez', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, 08950 Barcelona, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Ramon-Krauel', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, 08950 Barcelona, Spain.'}, {'ForeName': 'Carles', 'Initials': 'C', 'LastName': 'Lerin', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, 08950 Barcelona, Spain.'}]",Nutrients,['10.3390/nu12103123'] 851,33067919,Effectiveness of a low-dose mindfulness-based intervention for alleviating distress in young unemployed adults.,"While the effectiveness of mindfulness-based interventions (MBIs) with respect to distress has been widely researched, unemployed individuals, who often suffer from high levels of distress, have largely been neglected in MBI research. The present study aimed to investigate the effects of a low-dose MBI on distress in a sample of young unemployed adults. The sample included 239 young unemployed adults enrolled for a 6-week long employability-related training camp. Participants were allocated into an intervention group that received weekly 1-hour mindfulness training over 4 weeks, and a control group. Dispositional mindfulness, distress and well-being were assessed in the entire sample prior to the start and upon completion of the mindfulness training. A mixed model ANCOVA showed that distress was inversely and significantly predicted by baseline levels of mindfulness and well-being. After accounting for the baseline levels of mindfulness and well-being, a significant effect of the mindfulness intervention was evident. This result shows that a low-dose MBI can decrease distress in a sample of young unemployed adults and its effectiveness is positively associated with initial levels of dispositional mindfulness and well-being.",2021,"Dispositional mindfulness, distress and well-being were assessed in the entire sample prior to the start and upon completion of the mindfulness training.","['239 young unemployed adults enrolled for a six-week long employability-related training camp', 'young unemployed adults', 'Young Unemployed Adults']","['mindfulness-based interventions (MBIs', 'Low-dose Mindfulness-based Intervention', 'low-dose MBI']","['distress', 'Dispositional mindfulness, distress and well-being']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C2985547', 'cui_str': 'Scintimammography'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",239.0,0.0182494,"Dispositional mindfulness, distress and well-being were assessed in the entire sample prior to the start and upon completion of the mindfulness training.","[{'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Roemer', 'Affiliation': 'School of Psychology, University of Waikato, Hamilton, New Zealand.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Sutton', 'Affiliation': 'School of Psychology, University of Waikato, Hamilton, New Zealand.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Grimm', 'Affiliation': 'New Zealand Defence Force, Wellington, New Zealand.'}, {'ForeName': 'Oleg N', 'Initials': 'ON', 'LastName': 'Medvedev', 'Affiliation': 'School of Psychology, University of Waikato, Hamilton, New Zealand.'}]",Stress and health : journal of the International Society for the Investigation of Stress,['10.1002/smi.2997'] 852,33073847,"Survival, Dependency, and Health-Related Quality of Life in Patients With Ruptured Intracranial Aneurysm: 10-Year Follow-up of the United Kingdom Cohort of the International Subarachnoid Aneurysm Trial.","BACKGROUND Previous analyses of the International Subarachnoid Aneurysm Trial (ISAT) cohort have reported on clinical outcomes after treatment of a ruptured intracranial aneurysm with either neurosurgical clipping or endovascular coiling. OBJECTIVE To evaluate the long-term quality-adjusted life years (QALYs) gained of endovascular coiling compare to neurosurgical clipping in the UK cohort of ISAT. METHODS Between September 12, 1994 and May 1, 2002, patients with ruptured intracranial aneurysms who were assumed treatment equipoise were randomly allocated to either neurosurgical clipping or endovascular coiling. We followed-up 1644 patients in 22 UK neurosurgical centers for a minimum of 10 yr. Health-related quality of life (HRQoL) was collected through yearly questionnaires, measured by utilities calculated from the EQ-5D-3L. We compared HRQoL between the 2 treatment groups over a period of 10 yr. In all, 1-yr, 5-yr, and 10-yr QALYs were estimated by combining utility and survival information. RESULTS Higher average utility values were found in the endovascular group throughout the follow-up period, with mean differences between groups statistically significant in most years. The 10-yr QALYs were estimated to be 6.68 (95% CI: 6.45-6.90) in the coiling group and 6.32 (95% CI: 6.10-6.55) in the clipping group, respectively, a significant mean difference of 0.36 (95% CI: 0.04-0.66). A third of this mean QALYs gain was estimated to derive solely from HRQoL differences. CONCLUSION HRQoL after treatment of a ruptured intracranial aneurysm was better after endovascular coiling compared to neurosurgical clipping, which contributed significantly to the QALYs gained over a 10-yr period.",2021,"CONCLUSION HRQoL after treatment of a ruptured intracranial aneurysm was better after endovascular coiling compared to neurosurgical clipping, which contributed significantly to the QALYs gained over a 10-yr period.","['Patients With Ruptured Intracranial Aneurysm', 'patients with ruptured intracranial aneurysms who were assumed treatment equipoise', 'Between September 12, 1994 and May 1, 2002', '1644 patients in 22 UK neurosurgical centers for a minimum of 10 yr']","['endovascular coiling compare to neurosurgical clipping', 'neurosurgical clipping or endovascular coiling']","['Health-related quality of life (HRQoL', 'Survival, Dependency, and Health-Related Quality of Life', 'mean QALYs gain', 'average utility values', 'long-term quality-adjusted life years']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0007766', 'cui_str': 'Intracranial aneurysm'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0702057', 'cui_str': 'Equipoise'}, {'cui': 'C0205099', 'cui_str': 'Central'}]",[],"[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",,0.179777,"CONCLUSION HRQoL after treatment of a ruptured intracranial aneurysm was better after endovascular coiling compared to neurosurgical clipping, which contributed significantly to the QALYs gained over a 10-yr period.","[{'ForeName': 'Xinyang', 'Initials': 'X', 'LastName': 'Hua', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Gray', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Wolstenholme', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Clarke', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Molyneux', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Richard S C', 'Initials': 'RSC', 'LastName': 'Kerr', 'Affiliation': 'Department of Neurosurgery, John Radcliffe Hospital, Oxford, United Kingdom.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Clarke', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Sneade', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Rivero-Arias', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}]",Neurosurgery,['10.1093/neuros/nyaa454'] 853,33077017,"Cellular dehydration acutely degrades mood mainly in women: a counterbalanced, crossover trial.","It is unclear if mild-to-moderate dehydration independently affects mood without confounders like heat exposure or exercise. This study examined the acute effect of cellular dehydration on mood. Forty-nine adults (55 % female, age 39 (sd 8) years) were assigned to counterbalanced, crossover trials. Intracellular dehydration was induced with 2-h (0·1 ml/kg per min) 3 % hypertonic saline (HYPER) infusion or 0·9 % isotonic saline (ISO) as a control. Plasma osmolality increased in HYPER (pre 285 (sd 3), post 305 (sd 4) mmol/kg; P < 0·05) but remained unchanged in ISO (pre 285 (sd 3), post 288 (sd 3) mmol/kg; P > 0·05). Mood was assessed with the short version of the Profile of Mood States Questionnaire (POMS). The POMS sub-scale (confusion-bewilderment, depression-dejection, fatigue-inertia) increased in HYPER compared with ISO (P < 0·05). Total mood disturbance score (TMD) assessed by POMS increased from 10·3 (sd 0·9) to 16·6 (sd 1·7) in HYPER (P < 0·01), but not in ISO (P > 0·05). When TMD was stratified by sex, the increase in the HYPER trial was significant in females (P < 0·01) but not in males (P > 0·05). Following infusion, thirst and copeptin (surrogate for vasopressin) were also higher in females than in males (21·3 (sd 2·0), 14·1 (sd 1·4) pmol/l; P < 0·01) during HYPER. In conclusion, cellular dehydration acutely degraded specific aspects of mood mainly in women. The mechanisms underlying sex differences may be related to elevated thirst and vasopressin.",2020,"Following infusion, thirst and copeptin (surrogate for vasopressin) were also higher in females than in males (21·3 (sd 2·0),","['Forty-nine adults (55 % female, age 39 (sd 8) years', 'Cellular dehydration acutely degrades mood mainly in women']",['hypertonic saline (HYPER) infusion or 0·9 % isotonic saline (ISO'],"['ISO', 'POMS sub-scale (confusion-bewilderment, depression-dejection, fatigue-inertia', 'Intracellular dehydration', 'Profile of Mood States Questionnaire (POMS', 'Total mood disturbance score (TMD) assessed by POMS', 'Plasma osmolality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]","[{'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2939186', 'cui_str': 'Disturbance in mood'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0860721', 'cui_str': 'Plasma osmolality'}]",49.0,0.109317,"Following infusion, thirst and copeptin (surrogate for vasopressin) were also higher in females than in males (21·3 (sd 2·0),","[{'ForeName': 'HyunGyu', 'Initials': 'H', 'LastName': 'Suh', 'Affiliation': 'Arizona State University, College of Health Solutions, Hydration Science Lab, Phoenix, AZ85004, USA.'}, {'ForeName': 'Harris R', 'Initials': 'HR', 'LastName': 'Lieberman', 'Affiliation': 'Newton, MA, USA.'}, {'ForeName': 'Lisa T', 'Initials': 'LT', 'LastName': 'Jansen', 'Affiliation': 'Division of Endocrinology, New Balance Foundation Obesity Prevention Center, Boston, MA02215, USA.'}, {'ForeName': 'Abigail T', 'Initials': 'AT', 'LastName': 'Colburn', 'Affiliation': 'Arizona State University, College of Health Solutions, Hydration Science Lab, Phoenix, AZ85004, USA.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Adams', 'Affiliation': 'Department of Health and Human Performance, College of Charleston, Charleston, SC29424, USA.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'Seal', 'Affiliation': 'Arizona State University, College of Health Solutions, Hydration Science Lab, Phoenix, AZ85004, USA.'}, {'ForeName': 'Cory L', 'Initials': 'CL', 'LastName': 'Butts', 'Affiliation': 'Department of Exercise & Nutrition Sciences, Weber State University, Ogden, UT84408-2805, USA.'}, {'ForeName': 'Tracie M', 'Initials': 'TM', 'LastName': 'Kirkland', 'Affiliation': 'Department of Nursing, University of Southern California, Los Angeles, CA90033, USA.'}, {'ForeName': 'Olle', 'Initials': 'O', 'LastName': 'Melander', 'Affiliation': 'Division of Hypertension and Cardiovascular Disease, Lund University, 221 00 Malmø, Sweden.'}, {'ForeName': 'Tiphaine', 'Initials': 'T', 'LastName': 'Vanhaecke', 'Affiliation': 'Health, Hydration & Nutrition Science Department, Danone Research, 91120Palaiseau, France.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Dolci', 'Affiliation': 'Health, Hydration & Nutrition Science Department, Danone Research, 91120Palaiseau, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Lemetais', 'Affiliation': 'Health, Hydration & Nutrition Science Department, Danone Research, 91120Palaiseau, France.'}, {'ForeName': 'Erica T', 'Initials': 'ET', 'LastName': 'Perrier', 'Affiliation': 'Health, Hydration & Nutrition Science Department, Danone Research, 91120Palaiseau, France.'}, {'ForeName': 'Stavros A', 'Initials': 'SA', 'LastName': 'Kavouras', 'Affiliation': 'Arizona State University, College of Health Solutions, Hydration Science Lab, Phoenix, AZ85004, USA.'}]",The British journal of nutrition,['10.1017/S0007114520003475'] 854,33085094,"A single, clinically relevant dose of the GABA B agonist baclofen impairs visuomotor learning.","KEY POINTS Baclofen is a GABA B agonist prescribed as a treatment for spasticity in stroke, brain injury and multiple sclerosis patients, who are often undergoing concurrent motor rehabilitation. Decreasing GABAergic inhibition is a key feature of motor learning and so there is a possibility that GABA agonist drugs, such as baclofen, could impair these processes, potentially impacting rehabilitation. Here, we examined the effect of 10 mg of baclofen, in 20 young healthy individuals, and found that the drug impaired retention of visuomotor learning with no significant effect on motor sequence learning. Overall baclofen did not alter transcranial magnetic stimulation-measured GABA B inhibition, although the change in GABA B inhibition correlated with aspects of visuomotor learning retention. Further work is needed to investigate whether taking baclofen impacts motor rehabilitation in patients. ABSTRACT The GABA B agonist baclofen is taken daily as a treatment for spasticity by millions of stroke, brain injury and multiple sclerosis patients, many of whom are also undergoing motor rehabilitation. However, decreases in GABA are suggested to be a key feature of human motor learning, which raises questions about whether drugs increasing GABAergic activity may impair motor learning and rehabilitation. In this double-blind, placebo-controlled study, we investigated whether a single 10 mg dose of the GABA B agonist baclofen impaired motor sequence learning and visuomotor learning in 20 young healthy participants of both sexes. Participants trained on visuomotor and sequence learning tasks using their right hand. Transcranial magnetic stimulation (TMS) measures of corticospinal excitability, GABA A (short-interval intracortical inhibition , 2.5 ms) and GABA B (long-interval intracortical inhibition , 150 ms) receptor activation were recorded from left M1. Behaviourally, baclofen caused a significant reduction of visuomotor aftereffect (F 1,137.8  = 6.133, P = 0.014) and retention (F 1,130.7  = 4.138, P = 0.044), with no significant changes to sequence learning. There were no overall changes to TMS measured GABAergic inhibition with this low dose of baclofen. This result confirms the causal importance of GABA B inhibition in mediating visuomotor learning and suggests that chronic baclofen use could negatively impact aspects of motor rehabilitation.",2021,"Behaviourally, baclofen caused a significant reduction of visuomotor aftereffect (F(1,137.8) = 6.133, p = 0.014) and retention (F(1,130.7) =","['20 young healthy individuals', '20 young healthy participants of both sexes', 'patients']","['Baclofen', 'placebo', 'GABA B agonist baclofen', 'Transcranial magnetic stimulation (TMS']","['visuomotor aftereffect', 'sequence learning', 'visuomotor learning', 'Overall baclofen', 'motor sequence learning', 'TMS-measured GABA B inhibition', 'corticospinal excitability, GABA A (SICI 2.5ms ) and GABA B (LICI 150ms ) receptor activation', 'motor sequence learning and visuomotor learning']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0004609', 'cui_str': 'Baclofen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0004609', 'cui_str': 'Baclofen'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}]",20.0,0.0721447,"Behaviourally, baclofen caused a significant reduction of visuomotor aftereffect (F(1,137.8) = 6.133, p = 0.014) and retention (F(1,130.7) =","[{'ForeName': 'Ainslie', 'Initials': 'A', 'LastName': 'Johnstone', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, FMRIB, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ioana', 'Initials': 'I', 'LastName': 'Grigoras', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, FMRIB, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Petitet', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, FMRIB, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Liliana P', 'Initials': 'LP', 'LastName': 'Capitão', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Charlotte J', 'Initials': 'CJ', 'LastName': 'Stagg', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, FMRIB, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}]",The Journal of physiology,['10.1113/JP280378'] 855,32681995,Randomized Study Comparing a Reusable Morcellator with a Resectoscope in the Hysteroscopic Treatment of Uterine Polyps: The RESMO Study.,"STUDY OBJECTIVE To compare a reusable hysteroscopic morcellator and standard resectoscopes in the hysteroscopic management of uterine polyps. DESIGN Single-center randomized prospective single-blind trial (resectoscope-morcellator study). SETTING Centre Médico-chirurgical Obstétrique teaching hospital, Strasbourg University Hospitals, France. PATIENTS All patients presenting with a single endometrial polyp of size 1 cm or larger. INTERVENTIONS After consent, the patients were randomized into 2 groups: hysteroscopic morcellation (HM) group or standard resection (SR) group. Office-based review hysteroscopy was performed 6 weeks to 8 weeks after surgery. Primary end point: time of morcellation or resection. SECONDARY OUTCOMES total operating time (minutes), volume of fluid used (mL), fluid deficit (mL), number of morcellator or resectoscope insertions, operator comfort (visual analog scale: 0 to 10) and quality of vision (0 to 5), perioperative complications, completeness of resection, need to convert to another technique, pain assessment (visual analog scale), and length of hospitalization. At review hysteroscopy, we noted whether the resection or morcellation had been effective and if synechiae were present or absent. Statistical analyses followed Bayesian methods. MEASUREMENTS AND MAIN RESULTS Ninety patients were randomized: 45 in the HM group and 45 in the SR group. The average size of polyps at hysteroscopy was 13.3 mm. Morcellation time was lower than resection time (6.1 minutes vs 9 minutes; p [HM < SR] = .996). This also applied to total operating time (12.7 minutes vs 15.6 minutes; p [HM < SR] = .985), number of device insertions (1.50 vs 6; p [HM < SR] > .999), volume of fluid used (766.9 mL vs 1118.9 mL; p [HM < SR] = .994), and fluid deficit (60.2 mL vs 169.8 mL; p [HM < SR] = .989). Operator comfort was better in the HM group (8.4 vs 7.4; p [HM > SR] = .999) as was visualization (4 vs 3.7; p [HM > SR] = .911, highly probable). Operative complications were higher in the SR group (5 vs 0; p [HM < SR] = .989]. One patient in the SR group died after surgery owing to an anesthetic complication (anaphylactic shock complicated by pulmonary embolism). No differences were noted between the groups for pain assessment, length of hospitalization, and outcome on review hysteroscopy. CONCLUSION The reusable morcellator is quicker, uses less fluid with less deficit and fewer introductory maneuvers, and offers better comfort and visualization than the resectoscope while being as effective for the hysteroscopic treatment of uterine polyps.",2021,Operative complications were higher in the SR group [5 vs 0; P(HM='}, {'cui': 'C0475210', 'cui_str': 'cm'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0182966', 'cui_str': 'Resectoscope'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4042900', 'cui_str': 'Morcellation'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449971', 'cui_str': 'Volume of fluid used'}, {'cui': 'C0182966', 'cui_str': 'Resectoscope'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0439812', 'cui_str': 'Completeness'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",90.0,0.0507971,Operative complications were higher in the SR group [5 vs 0; P(HM0.05 for both), but both were found to increase over the duration of follow-up (0.07 [0.03-0.12]; P =0.001 and 0.5 m/s [0.4-0.6]; P <0.001 for reactive hyperemia index and pulse wave velocity, respectively). ACE inhibitors improve endothelial function in high-risk adolescents as they transition through puberty. The longer-term protective effects of this intervention at this early age remain to be determined. Registration- URL: https://www.clinicaltrials.gov; Unique identifier NCT01581476.",2020,"Neither reactive hyperemia index nor pulse wave velocity were affected by either treatment ( P >0.05 for both), but both were found to increase over the duration of follow-up (0.07 [0.03-0.12]; P =0.001 and 0.5 m/s [0.4-0.6]; P <0.001 for reactive hyperemia index and pulse wave velocity, respectively).","['adolescents with type 1 diabetes (AdDIT [Adolescent Type 1 Diabetes cardio-renal Intervention Trial', 'Adolescents With Type 1 Diabetes', 'high-risk adolescents', '215 lower-risk individuals', '158 high-risk participants']","['ACE inhibitors', 'placebo', 'ACE inhibitors and/or statins', 'ACE (angiotensin-converting enzyme) inhibitors and statins', 'Inhibitors and Statins', 'ACE (Angiotensin-Converting Enzyme']","['flow-mediated dilation', 'Endothelial function (flow-mediated dilation and reactive hyperemia index) and arterial stiffness (carotid-femoral pulse wave velocity', 'albumin-creatinine ratio', 'endothelial dysfunction', 'reactive hyperemia index nor pulse wave velocity', 'endothelial function']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0022709', 'cui_str': 'Dipeptidyl carboxypeptidase I'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}, {'cui': 'C0486293', 'cui_str': 'Albumin/creatinine ratio measurement'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}]",158.0,0.579727,"Neither reactive hyperemia index nor pulse wave velocity were affected by either treatment ( P >0.05 for both), but both were found to increase over the duration of follow-up (0.07 [0.03-0.12]; P =0.001 and 0.5 m/s [0.4-0.6]; P <0.001 for reactive hyperemia index and pulse wave velocity, respectively).","[{'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Chiesa', 'Affiliation': 'From the Institute of Cardiovascular Science, University College London, United Kingdom (S.T.C., J.E.D.).'}, {'ForeName': 'M Loredana', 'Initials': 'ML', 'LastName': 'Marcovecchio', 'Affiliation': 'Department of Paediatrics (M.L.M., D.B.D.), University of Cambridge, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Benitez-Aguirre', 'Affiliation': ""Institute of Endocrinology and Diabetes, The Children's Hospital at Westmead, University of Sydney, Camperdown, Australia (P.B.-A., K.C.D.).""}, {'ForeName': 'Fergus J', 'Initials': 'FJ', 'LastName': 'Cameron', 'Affiliation': 'Department of Paediatrics, University of Melbourne, Australia (F.J.C.).'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Craig', 'Affiliation': ""School of Women's and Children's Health, University of New South Wales, Australia (M.E.C.).""}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Couper', 'Affiliation': ""Departments of Endocrinology and Diabetes, Women's and Children's Hospital, Robinson Research Institute, University of Adelaide, Australia (J.J.C.).""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Davis', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Perth (E.A.D., T.W.J.).'}, {'ForeName': 'R Neil', 'Initials': 'RN', 'LastName': 'Dalton', 'Affiliation': ""Guy's and St Thomas' National Health Service Foundation Trust, London, United Kingdom (R.N.D.).""}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Daneman', 'Affiliation': 'Department of Paediatrics, The Hospital for Sick Children, University of Toronto, ON, Canada (D.D., F.H.M.).'}, {'ForeName': 'Kim C', 'Initials': 'KC', 'LastName': 'Donaghue', 'Affiliation': ""Institute of Endocrinology and Diabetes, The Children's Hospital at Westmead, University of Sydney, Camperdown, Australia (P.B.-A., K.C.D.).""}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Jones', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Perth (E.A.D., T.W.J.).'}, {'ForeName': 'Farid H', 'Initials': 'FH', 'LastName': 'Mahmud', 'Affiliation': 'Department of Paediatrics, The Hospital for Sick Children, University of Toronto, ON, Canada (D.D., F.H.M.).'}, {'ForeName': 'Sally M', 'Initials': 'SM', 'LastName': 'Marshall', 'Affiliation': 'Institute of Cellular Medicine (Diabetes), Faculty of Clinical Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (S.M.M.).'}, {'ForeName': 'H Andrew W', 'Initials': 'HAW', 'LastName': 'Neil', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology, and Metabolism, University of Oxford, United Kingdom (H.A.W.N.).'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Dunger', 'Affiliation': 'Department of Paediatrics (M.L.M., D.B.D.), University of Cambridge, United Kingdom.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Deanfield', 'Affiliation': 'From the Institute of Cardiovascular Science, University College London, United Kingdom (S.T.C., J.E.D.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.15721'] 881,33100049,Effects of Intensive Systolic Blood Pressure Control on All-Cause Hospitalizations.,"Intensive blood pressure control decreases the rate of cardiovascular events by >25% compared with standard blood pressure control. We sought to determine whether the decrease in cardiovascular events seen with intensive blood pressure control is associated with an increased rate of other causes of hospitalization. This is a post hoc analysis of SPRINT (Systolic Blood Pressure Intervention Trial) in 9361 adult participants with hypertension and elevated cardiovascular risk. Participants were randomly assigned to an intensive or standard systolic blood pressure goal (<120 or <140 mm Hg, respectively). The primary outcome was hospitalization rates per 100 person-years for hospitalizations not associated with SPRINT primary events. After excluding hospitalizations linked to SPRINT primary events, there were 4678 participants with a rate of 19.70 hospitalizations per 100 person-years, compared with 4683 participants with a rate of 19.65 ( P =0.37). Equivalence testing shows that these hospitalization rates were statistically equivalent at the P =0.05 level. Of those with hospitalizations, >1 hospitalization was seen in 38.8% of intensive arm participants and 41.9% of standard arm participants ( P =0.08). The mean cumulative count of nonprimary event hospitalizations was comparable between the two arms. The most common causes of hospitalization were cardiovascular (23.6%) followed by injuries, including bone and joint therapeutic procedures (15.7%), infections (12.0%), and nervous systems disorders (10.7%). No categories of hospitalization were statistically more common in the intensive arm compared with the standard arm. Thus, the decrease in cardiovascular events seen with intensive blood pressure control is not associated with an increased rate of other causes of hospitalization. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT01206062.",2020,Intensive blood pressure control decreases the rate of cardiovascular events by >25% compared with standard blood pressure control.,"['9361 adult participants with hypertension and elevated cardiovascular risk', '4678 participants with a rate of 19.70 hospitalizations per 100 person-years, compared with 4683 participants with a rate of 19.65 ( P =0.37']","['intensive or standard systolic blood pressure goal', 'Intensive Systolic Blood Pressure Control']","['hospitalization rates', 'bone and joint therapeutic procedures', 'categories of hospitalization', 'nervous systems disorders', 'mean cumulative count of nonprimary event hospitalizations', 'cardiovascular events', 'hospitalization rates per 100 person-years for hospitalizations not associated with SPRINT primary events', 'rate of cardiovascular events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517454', 'cui_str': '0.37'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0948995', 'cui_str': 'Bone and joint therapeutic procedures'}, {'cui': 'C0027765', 'cui_str': 'Disorder of nervous system'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]",9361.0,0.192607,Intensive blood pressure control decreases the rate of cardiovascular events by >25% compared with standard blood pressure control.,"[{'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Rocco', 'Affiliation': 'From the Departments of Internal Medicine (M.V.R., B.I.F., A.T.H.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Comeau', 'Affiliation': 'Biostatistics and Data Science (M.E.C., M.C.M., C.D.L.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Miranda C', 'Initials': 'MC', 'LastName': 'Marion', 'Affiliation': 'Biostatistics and Data Science (M.E.C., M.C.M., C.D.L.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Barry I', 'Initials': 'BI', 'LastName': 'Freedman', 'Affiliation': 'From the Departments of Internal Medicine (M.V.R., B.I.F., A.T.H.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Amret T', 'Initials': 'AT', 'LastName': 'Hawfield', 'Affiliation': 'From the Departments of Internal Medicine (M.V.R., B.I.F., A.T.H.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Carl D', 'Initials': 'CD', 'LastName': 'Langefeld', 'Affiliation': 'Biostatistics and Data Science (M.E.C., M.C.M., C.D.L.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.15868'] 882,33106874,OrderRex clinical user testing: a randomized trial of recommender system decision support on simulated cases.,"OBJECTIVE To assess usability and usefulness of a machine learning-based order recommender system applied to simulated clinical cases. MATERIALS AND METHODS 43 physicians entered orders for 5 simulated clinical cases using a clinical order entry interface with or without access to a previously developed automated order recommender system. Cases were randomly allocated to the recommender system in a 3:2 ratio. A panel of clinicians scored whether the orders placed were clinically appropriate. Our primary outcome included the difference in clinical appropriateness scores. Secondary outcomes included total number of orders, case time, and survey responses. RESULTS Clinical appropriateness scores per order were comparable for cases randomized to the order recommender system (mean difference -0.11 order per score, 95% CI: [-0.41, 0.20]). Physicians using the recommender placed more orders (median 16 vs 15 orders, incidence rate ratio 1.09, 95%CI: [1.01-1.17]). Case times were comparable with the recommender system. Order suggestions generated from the recommender system were more likely to match physician needs than standard manual search options. Physicians used recommender suggestions in 98% of available cases. Approximately 95% of participants agreed the system would be useful for their workflows. DISCUSSION User testing with a simulated electronic medical record interface can assess the value of machine learning and clinical decision support tools for clinician usability and acceptance before live deployments. CONCLUSIONS Clinicians can use and accept machine learned clinical order recommendations integrated into an electronic order entry interface in a simulated setting. The clinical appropriateness of orders entered was comparable even when supported by automated recommendations.",2020,"Physicians using the recommender placed more orders (median 16 vs 15 orders, incidence rate ratio 1.09, 95%CI: [1.01-1.17]).",['43 physicians entered orders for 5 simulated clinical cases using a clinical order entry interface with or without access to a previously developed automated order recommender system'],['machine learning-based order recommender system'],"['clinical appropriateness scores', 'total number of orders, case time, and survey responses']","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",,0.0423634,"Physicians using the recommender placed more orders (median 16 vs 15 orders, incidence rate ratio 1.09, 95%CI: [1.01-1.17]).","[{'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Division of Hospital Medicine, Department of Medicine, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Rachael C', 'Initials': 'RC', 'LastName': 'Aikens', 'Affiliation': 'Program in Biomedical Informatics, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Hom', 'Affiliation': 'Division of Hospital Medicine, Department of Medicine, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Shieh', 'Affiliation': 'Division of Hospital Medicine, Department of Medicine, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Chiang', 'Affiliation': 'Department of Medicine, Center for Biomedical Informatics Research, Stanford University, Stanford, California, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Morales', 'Affiliation': 'Department of Computer Science, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Saini', 'Affiliation': 'Department of Computer Science, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Musen', 'Affiliation': 'Department of Medicine, Center for Biomedical Informatics Research, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Baiocchi', 'Affiliation': 'Department of Epidemiology and Public Health, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Russ', 'Initials': 'R', 'LastName': 'Altman', 'Affiliation': 'Departments of Bioengineering, Genetics, Medicine, and Biomedical Data Science, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Goldstein', 'Affiliation': 'Geriatrics Research Education and Clinical Center, Veteran Affairs Palo Alto Health Care System, Palo Alto, California, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Asch', 'Affiliation': 'Primary Care and Population Health, Department of Medicine, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Jonathan H', 'Initials': 'JH', 'LastName': 'Chen', 'Affiliation': 'Division of Hospital Medicine, Department of Medicine, Stanford University, Stanford, California, USA.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocaa190'] 883,33106892,Safety and efficacy of sucroferric oxyhydroxide in pediatric patients with chronic kidney disease.,"BACKGROUND Pediatric patients with advanced chronic kidney disease (CKD) are often prescribed oral phosphate binders (PBs) for the management of hyperphosphatemia. However, available PBs have limitations, including unfavorable tolerability and safety. METHODS This phase 3, multicenter, randomized, open-label study investigated safety and efficacy of sucroferric oxyhydroxide (SFOH) in pediatric and adolescent subjects with CKD and hyperphosphatemia. Subjects were randomized to SFOH or calcium acetate (CaAc) for a 10-week dose titration (stage 1), followed by a 24-week safety extension (stage 2). Primary efficacy endpoint was change in serum phosphorus from baseline to the end of stage 1 in the SFOH group. Safety endpoints included treatment-emergent adverse events (TEAEs). RESULTS Eighty-five subjects (2-18 years) were randomized and treated (SFOH, n = 66; CaAc, n = 19). Serum phosphorus reduction from baseline to the end of stage 1 in the overall SFOH group (least squares [LS] mean ± standard error [SE]) was - 0.488 ± 0.186 mg/dL; p = 0.011 (post hoc analysis). Significant reductions in serum phosphorus were observed in subjects aged ≥ 12 to ≤ 18 years (LS mean ± SE - 0.460 ± 0.195 mg/dL; p = 0.024) and subjects with serum phosphorus above age-related normal ranges at baseline (LS mean ± SE - 0.942 ± 0.246 mg/dL; p = 0.005). Similar proportions of subjects reported ≥ 1 TEAE in the SFOH (75.8%) and CaAc (73.7%) groups. Withdrawal due to TEAEs was more common with CaAc (31.6%) than with SFOH (18.2%). CONCLUSIONS SFOH effectively managed serum phosphorus in pediatric patients with a low pill burden and a safety profile consistent with that reported in adult patients.",2021,Significant reductions in serum phosphorus were observed in subjects aged ≥ 12 to ≤ 18 years (LS mean ± SE - 0.460 ± 0.195 mg/dL; p = 0.024) and subjects with serum phosphorus above age-related normal ranges at baseline (LS mean ± SE - 0.942 ± 0.246 mg/dL; p = 0.005).,"['pediatric patients with chronic kidney disease', 'pediatric patients', 'Pediatric patients with advanced chronic kidney disease (CKD', 'pediatric and adolescent subjects with CKD and hyperphosphatemia', 'Eighty-five subjects (2-18\xa0years']","['SFOH or calcium acetate (CaAc', 'sucroferric oxyhydroxide', 'sucroferric oxyhydroxide (SFOH', 'oral phosphate binders (PBs']","['Serum phosphorus reduction', 'Safety and efficacy', 'unfavorable tolerability and safety', 'serum phosphorus', 'treatment-emergent adverse events (TEAEs']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0085681', 'cui_str': 'Hyperphosphatemia'}, {'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C3696416', 'cui_str': 'sucroferric oxyhydroxide'}, {'cui': 'C0717537', 'cui_str': 'calcium acetate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0179302', 'cui_str': 'Binder'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",85.0,0.0439703,Significant reductions in serum phosphorus were observed in subjects aged ≥ 12 to ≤ 18 years (LS mean ± SE - 0.460 ± 0.195 mg/dL; p = 0.024) and subjects with serum phosphorus above age-related normal ranges at baseline (LS mean ± SE - 0.942 ± 0.246 mg/dL; p = 0.005).,"[{'ForeName': 'Larry A', 'Initials': 'LA', 'LastName': 'Greenbaum', 'Affiliation': ""Division of Pediatric Nephrology, Emory University School of Medicine and Children's Healthcare of Atlanta, 2015 Uppergate Drive NE, Atlanta, GA, 30322, USA. lgreen6@emory.edu.""}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Jeck', 'Affiliation': 'KfH Pediatric Kidney Center and Department of Pediatrics II, Philipps-University, Marburg, Germany.'}, {'ForeName': 'Günter', 'Initials': 'G', 'LastName': 'Klaus', 'Affiliation': 'KfH Pediatric Kidney Center and Department of Pediatrics II, Philipps-University, Marburg, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Fila', 'Affiliation': 'CHU Hôpital Arnaud de Villeneuve, Montpellier, France.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Stoica', 'Affiliation': 'Institutul Clinic Fundeni, Bucharest, Romania.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Fathallah-Shaykh', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Paredes', 'Affiliation': ""Nicklaus Children's Hospital, Miami, FL, USA.""}, {'ForeName': 'Larysa', 'Initials': 'L', 'LastName': 'Wickman', 'Affiliation': ""C.S Mott Children's Hospital, Michigan Medicine, Ann Arbor, MI, USA.""}, {'ForeName': 'Raoul', 'Initials': 'R', 'LastName': 'Nelson', 'Affiliation': 'University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Rita D', 'Initials': 'RD', 'LastName': 'Swinford', 'Affiliation': 'The University of Texas Medical School at Houston, Houston, TX, USA.'}, {'ForeName': 'Carolyn Larkins', 'Initials': 'CL', 'LastName': 'Abitbol', 'Affiliation': 'University of Miami - Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Balgradean', 'Affiliation': 'UMF \'Carol Davila\' Spitalul Clinic de Urgenţă pentru copii ""Maria Sklodowska Curie"", Bucharest, Romania.'}, {'ForeName': 'Augustina', 'Initials': 'A', 'LastName': 'Jankauskiene', 'Affiliation': 'Vilnius University hospital Santaros klinikos, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Amandine', 'Initials': 'A', 'LastName': 'Perrin', 'Affiliation': 'Vifor Pharma Management Ltd., Glattbrugg, Switzerland.'}, {'ForeName': 'Milica', 'Initials': 'M', 'LastName': 'Enoiu', 'Affiliation': 'Vifor Pharma Management Ltd., Glattbrugg, Switzerland.'}, {'ForeName': 'Sun-Young', 'Initials': 'SY', 'LastName': 'Ahn', 'Affiliation': ""Children's National Hospital, The George Washington University, Washington, DC, USA.""}]","Pediatric nephrology (Berlin, Germany)",['10.1007/s00467-020-04805-y'] 884,33108030,One-year aerobic interval training in outpatients with schizophrenia: A randomized controlled trial.,"Although aerobic interval training (AIT) is recognized to attenuate the risk of cardiovascular disease (CVD) and premature mortality, it appears that it rarely arrives at patients' doorsteps. Thus, this study investigated 1-year effects and feasibility of AIT delivered with adherence support in collaborative care of outpatients with schizophrenia. Forty-eight outpatients (28 men, 35 [31-38] (mean [95% confidence intervals]) years; 20 women, 36 [30-41] years) with schizophrenia spectrum disorders (ICD-10) were randomized to either a collaborative care group provided with municipal transportation service and training supervision (walking/running 4 × 4 minutes at ~90% of peak heart rate; HR peak ) 2 d wk -1 at the clinic (TG) or a control group (CG) given 2 introductory AIT sessions and advised to continue training. Directly assessed peak oxygen uptake ( V ˙ O 2 peak ) increased in the TG after 3 months (2.3 [0.6-4.4] mL kg -1  min -1 , Cohen's d = 0.33[-4.63 to 4.30], P = 0.04), 6 months (2.7 [0.5-4.8] mL kg -1  min -1 , Cohen's d = 0.42[-4.73 to 4.11], P = 0.02) and 1 year (4.6 [2.3-6.8] mL kg -1  min -1 , Cohen's d = 0.70[-4.31 to 4.10], P < 0.001) compared to the CG. One-year cardiac effects revealed higher HR peak (7 [2-11] b min -1 , Cohen's d = 0.34[-8.48 to 8.65], P = 0.01), while peak stroke volume tended to be higher (0.9 [-0.2 to 2.0] mL b -1 , Cohen's d = 0.35[-1.62 to 2.01], P = 0.11) in the TG compared to the CG. Conventional risk factors (body weight, waist circumference, blood pressure, and lipids/glucose) remained unaltered in both groups. One-year AIT adherence rates were 15/25 (TG; different from CG: P < 0.001) and 0/23 (CG). AIT was successfully included in long-term collaborative care of outpatients with schizophrenia and yielded improved V ˙ O 2 peak , advocating this model for aerobic capacity improvement and CVD risk reduction in future treatment.",2020,One-year AIT adherence rates were 15/25 (TG; different from CG: P < 0.001) and 0/23 (CG).,"['years; 20 women, 36 [30-41] years) with schizophrenia spectrum disorders (ICD-10', 'outpatients with schizophrenia and yielded improved V', 'outpatients with schizophrenia', 'Forty-eight outpatients (28 men, 35 [31-38] (mean [95% confidence intervals']","['collaborative care group provided with municipal transportation service and training supervision (walking/running 4\xa0×\xa04\xa0minutes at ~90% of peak heart rate; HR peak ) 2\xa0d\xa0wk -1 at the clinic (TG) or a control group (CG) given 2 introductory AIT sessions and advised to continue training', 'aerobic interval training', 'aerobic interval training (AIT']","['Conventional risk factors (body weight, waist circumference, blood pressure, and lipids/glucose', 'aerobic capacity improvement and CVD risk reduction', 'One-year AIT adherence rates', 'peak oxygen uptake ( V', 'peak stroke volume', 'HR peak']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1828381', 'cui_str': 'Recommendation - action'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}]",48.0,0.0540508,One-year AIT adherence rates were 15/25 (TG; different from CG: P < 0.001) and 0/23 (CG).,"[{'ForeName': 'Mathias Forsberg', 'Initials': 'MF', 'LastName': 'Brobakken', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Nygård', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Ismail Cüneyt', 'Initials': 'IC', 'LastName': 'Güzey', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Morken', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Solveig Klaebo', 'Initials': 'SK', 'LastName': 'Reitan', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Jørn', 'Initials': 'J', 'LastName': 'Heggelund', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Einar', 'Initials': 'E', 'LastName': 'Vedul-Kjelsaas', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Wang', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13808'] 885,33109892,"Response to Article ""A Comparison of Hypertonic Saline (HTS) and Mannitol on Intraoperative Brain Relaxation in Patients with Raised Intracranial Pressure During Supratentorial Tumors Resection: A Randomized Control Trial"".",,2020,,"['Patients with Raised Intracranial Pressure', 'During Supratentorial Tumors Resection']",['Hypertonic Saline (HTS) and Mannitol'],['Intraoperative Brain Relaxation'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0151740', 'cui_str': 'Raised intracranial pressure'}, {'cui': 'C0038874', 'cui_str': 'Neoplasms, Supratentorial'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}]",,0.0925056,,"[{'ForeName': 'Hrishikesh', 'Initials': 'H', 'LastName': 'Sarkar', 'Affiliation': 'Senior Consultant, Neurosurgery, Department of Neurosciences, Kokilaben Dhirubhai Ambani Hospital, Mumbai, Maharashtra, India.'}]",Neurology India,['10.4103/0028-3886.299166'] 886,33109893,"In Reply to the Response to Article ""A Comparison of Hypertonic Saline (HTS) and Mannitol on Intraoperative Brain Relaxation in Patients with Raised Intracranial Pressure during Supratentorial Tumors Resection: A Randomized Control Trial"".",,2020,,['Patients with Raised Intracranial Pressure during Supratentorial Tumors Resection'],['Hypertonic Saline (HTS) and Mannitol'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0151740', 'cui_str': 'Raised intracranial pressure'}, {'cui': 'C0038874', 'cui_str': 'Neoplasms, Supratentorial'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}]",[],,0.0764808,,"[{'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Jangra', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Ankush', 'Initials': 'A', 'LastName': 'Singla', 'Affiliation': 'Department of Anaesthesia, Adesh Medical College, Bhathinda, Punjab, India.'}, {'ForeName': 'Preethy J', 'Initials': 'PJ', 'LastName': 'Mathew', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}]",Neurology India,['10.4103/0028-3886.299135'] 887,33068157,Six months vitamin K treatment does not affect systemic arterial calcification or bone mineral density in diabetes mellitus 2.,"PURPOSE Vitamin K-dependent proteins are involved in (patho)physiological calcification of the vasculature and the bones. Type 2 diabetes mellitus (DM2) is associated with increased arterial calcification and increased fractures. This study investigates the effect of 6 months vitamin K2 supplementation on systemic arterial calcification and bone mineral density (BMD) in DM2 patients with a history of cardiovascular disease (CVD). METHODS In this pre-specified, post hoc analysis of a double-blind, randomized, controlled clinical trial, patients with DM2 and CVD were randomized to a daily, oral dose of 360 µg vitamin K2 or placebo for 6 months. CT scans were made at baseline and follow-up. Arterial calcification mass was quantified in several large arterial beds and a total arterial calcification mass score was calculated. BMD was assessed in all non-fractured thoracic and lumbar vertebrae. RESULTS 68 participants were randomized, 35 to vitamin K2 (33 completed follow-up) and 33 to placebo (27 completed follow-up). The vitamin K group had higher arterial calcification mass at baseline [median (IQR): 1694 (812-3584) vs 1182 (235-2445)] for the total arterial calcification mass). Six months vitamin K supplementation did not reduce arterial calcification progression (β [95% CI]: - 0.02 [- 0.10; 0.06] for the total arterial calcification mass) or slow BMD decline (β [95% CI]: - 2.06 [- 11.26; 7.30] Hounsfield units for all vertebrae) when compared to placebo. CONCLUSION Six months vitamin K supplementation did not halt progression of arterial calcification or decline of BMD in patients with DM2 and CVD. Future clinical trials may want to pre-select patients with very low vitamin K status and longer follow-up time might be warranted. This trial was registered at clinicaltrials.gov as NCT02839044.",2021,Six months vitamin K supplementation did not reduce arterial calcification progression (β [95% CI]: - 0.02,"['68 participants were randomized, 35 to', 'patients with DM2 and CVD', 'DM2 patients with a history of cardiovascular disease (CVD', 'Type 2 diabetes mellitus (DM2']","['vitamin K2 or placebo', 'vitamin K2', 'vitamin K', 'vitamin K supplementation', 'placebo', 'vitamin K treatment', 'vitamin K2 supplementation']","['systemic arterial calcification or bone mineral density', 'systemic arterial calcification and bone mineral density (BMD', 'arterial calcification and increased fractures', 'arterial calcification mass', 'Arterial calcification mass', 'total arterial calcification mass) or slow BMD decline', 'progression of arterial calcification or decline of BMD', 'arterial calcification progression', 'BMD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1300562', 'cui_str': 'dm2'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0455539', 'cui_str': 'H/O: cardiovascular disease'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0065936', 'cui_str': 'menatetrenone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042878', 'cui_str': 'Vitamin K'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C1168153', 'cui_str': 'Arterial calcification'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",68.0,0.769215,Six months vitamin K supplementation did not reduce arterial calcification progression (β [95% CI]: - 0.02,"[{'ForeName': 'Jonas W', 'Initials': 'JW', 'LastName': 'Bartstra', 'Affiliation': 'Department of Radiology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Fieke', 'Initials': 'F', 'LastName': 'Draaisma', 'Affiliation': 'Department of Radiology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Sabine R', 'Initials': 'SR', 'LastName': 'Zwakenberg', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Nikolas', 'Initials': 'N', 'LastName': 'Lessmann', 'Affiliation': 'Diagnostic Image Analysis Group, Department of Radiology and Nuclear Medicine, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Jelmer M', 'Initials': 'JM', 'LastName': 'Wolterink', 'Affiliation': 'Department of Applied Mathematics, Technical Medical Centre, University of Twente, Enschede, The Netherlands.'}, {'ForeName': 'Yvonne T', 'Initials': 'YT', 'LastName': 'van der Schouw', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Pim A', 'Initials': 'PA', 'LastName': 'de Jong', 'Affiliation': 'Department of Radiology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Joline W J', 'Initials': 'JWJ', 'LastName': 'Beulens', 'Affiliation': 'Department of Epidemiology and Data Science, Amsterdam University Medical Centers, Location VUmc, Amsterdam Public Health and Amsterdam Cardiovascular Sciences Research Institutes, Postbox 7057, 1007 MB, Amsterdam, The Netherlands. j.beulens@amsterdamumc.nl.'}]",European journal of nutrition,['10.1007/s00394-020-02412-z'] 888,33068165,Higher rate of complications with uncemented compared to cemented total hip arthroplasty for displaced intracapsular hip fractures: A randomised controlled trial of 50 patients.,"BACKGROUND The primary aim of this study was to compare the functional outcome of uncemented with cemented total hip arthroplasty (THA) for displaced intracapsular hip fractures. The secondary aims were to assess length of surgery, blood loss, complications and revision rate between the two groups. METHODS A prospective double-blind randomised control trial was conducted. Fifty patients with an intracapsular hip fracture meeting the inclusion criteria were randomised to either an uncemented (n = 25) or cemented (n = 25) THA. There were no differences (p > 0.45) in age, gender, health status or preinjury hip function between the groups. The Oxford hip score (OHS), Harris Hip score (HHS), EuroQol 5-dimensional (EQ5D), timed get up-and-go (TUG), pain and patient satisfaction were used to assess outcome. These were assessed at 4, 12 and 72 months after surgery, apart from the TUG which as only assessed as 6 months. RESULTS The study was terminated early due to the significantly (n = 8, p = 0.004) higher rate of intraoperative complications in the uncemented group: three fractures of the proximal femur and five conversions to a cemented acetabular component. There were no significant (p ≥ 0.09) differences in the functional measures (OHS, HSS, EQ5D, TUG and pain) or patient satisfaction between the groups. There was no difference in operative time (p = 0.75) or blood loss (p = 0.66) between the groups. There were two early revisions prior to 3 months post-operatively in the uncemented group and none in the cemented group, but this was not significant (log rank p = 0.16). CONCLUSION There was a high rate of intraoperative complications, which may be due to poor bone quality in this patient group. There were no ergonomic or functional advantages demonstrated between uncemented and cemented THA. Cemented THA should remain as the preferred choice for the treatment of intracapsular hip fractures for patients that meet the criteria for this procedure.",2021,There was no difference in operative time (p = 0.75) or blood loss (p = 0.66) between the groups.,"['displaced intracapsular hip fractures', 'Fifty patients with an\xa0intracapsular hip fracture meeting the inclusion criteria were randomised to either an uncemented (n\u2009=\u200925) or cemented (n\u2009=\u200925', '50 patients']","['Cemented THA', 'cemented total hip arthroplasty', 'uncemented with cemented total hip arthroplasty (THA']","['length of surgery, blood loss, complications and revision rate', 'operative time', 'Oxford hip score (OHS), Harris Hip score (HHS), EuroQol 5-dimensional', 'ergonomic or functional advantages', 'EQ5D), timed get up-and-go (TUG), pain and patient satisfaction', 'functional measures (OHS, HSS, EQ5D, TUG and pain) or patient satisfaction', 'rate of intraoperative complications', 'blood loss']","[{'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}]","[{'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1998079', 'cui_str': 'Oxford hip score'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0086246', 'cui_str': 'Human Engineering'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018522', 'cui_str': 'Hallermann-Streiff syndrome'}, {'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}]",50.0,0.0973662,There was no difference in operative time (p = 0.75) or blood loss (p = 0.66) between the groups.,"[{'ForeName': 'N D', 'Initials': 'ND', 'LastName': 'Clement', 'Affiliation': 'Department of Orthopaedics and Trauma, The Royal Infirmary of Edinburgh, Little France, Edinburgh, EH16 4SA, UK. nickclement@doctors.org.uk.'}, {'ForeName': 'Marietta', 'Initials': 'M', 'LastName': 'van der Linden', 'Affiliation': 'Centre for Health Activity and Rehabilitation Research, Queen Margaret University, Edinburgh, EH21 6UU, UK.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Keating', 'Affiliation': 'Department of Orthopaedics and Trauma, The Royal Infirmary of Edinburgh, Little France, Edinburgh, EH16 4SA, UK.'}]",European journal of orthopaedic surgery & traumatology : orthopedie traumatologie,['10.1007/s00590-020-02808-x'] 889,33077004,Targeted gown and glove use to prevent Staphylococcus aureus acquisition in community-based nursing homes: A pilot study.,"OBJECTIVE To test the feasibility of targeted gown and glove use by healthcare personnel caring for high-risk nursing-home residents to prevent Staphylococcus aureus acquisition in short-stay residents. DESIGN Uncontrolled clinical trial. SETTING This study was conducted in 2 community-based nursing homes in Maryland. PARTICIPANTS The study included 322 residents on mixed short- and long-stay units. METHODS During a 2-month baseline period, all residents had nose and inguinal fold swabs taken to estimate S. aureus acquisition. The intervention was iteratively developed using a participatory human factors engineering approach. During a 2-month intervention period, healthcare personnel wore gowns and gloves for high-risk care activities while caring for residents with wounds or medical devices, and S. aureus acquisition was measured again. Whole-genome sequencing was used to assess whether the acquisition represented resident-to-resident transmission. RESULTS Among short-stay residents, the methicillin-resistant S. aureus acquisition rate decreased from 11.9% during the baseline period to 3.6% during the intervention period (odds ratio [OR], 0.28; 95% CI, 0.08-0.92; P = .026). The methicillin-susceptible S. aureus acquisition rate went from 9.1% during the baseline period to 4.0% during the intervention period (OR, 0.41; 95% CI, 0.12-1.42; P = .15). The S. aureus resident-to-resident transmission rate decreased from 5.9% during the baseline period to 0.8% during the intervention period. CONCLUSIONS Targeted gown and glove use by healthcare personnel for high-risk care activities while caring for residents with wounds or medical devices, regardless of their S. aureus colonization status, is feasible and potentially decreases S. aureus acquisition and transmission in short-stay community-based nursing-home residents.",2021,"The S. aureus resident-to-resident transmission rate decreased from 5.9% during the baseline period to 0.8% during the intervention period. ","['2 community-based nursing homes in Maryland', '322 residents on mixed short- and long-stay units', 'community-based nursing homes', 'high-risk nursing-home residents']",['healthcare personnel wore gowns and gloves for high-risk care activities while caring'],"['transmission rate', 'methicillin-susceptible S. aureus acquisition rate', 'methicillin-resistant S. aureus acquisition rate']","[{'cui': 'C0009471', 'cui_str': 'Nursing, Community Health'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C4517712', 'cui_str': '322'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}]","[{'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0181064', 'cui_str': 'Gown'}, {'cui': 'C0206069', 'cui_str': 'Glove'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0025643', 'cui_str': 'methicillin'}, {'cui': 'C0231204', 'cui_str': 'Susceptible'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C1955827', 'cui_str': 'Methicillin-Resistant'}]",322.0,0.0521733,"The S. aureus resident-to-resident transmission rate decreased from 5.9% during the baseline period to 0.8% during the intervention period. ","[{'ForeName': 'Alison D', 'Initials': 'AD', 'LastName': 'Lydecker', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Patience A', 'Initials': 'PA', 'LastName': 'Osei', 'Affiliation': 'Armstrong Institute Center for Health Care Human Factors, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Pineles', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'J Kristie', 'Initials': 'JK', 'LastName': 'Johnson', 'Affiliation': 'Department of Pathology, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Jacquelyn', 'Initials': 'J', 'LastName': 'Meisel', 'Affiliation': 'Center for Bioinformatics and Computational Biology, University of Maryland, College Park, Maryland.'}, {'ForeName': 'O Colin', 'Initials': 'OC', 'LastName': 'Stine', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Magder', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Ayse P', 'Initials': 'AP', 'LastName': 'Gurses', 'Affiliation': 'Armstrong Institute Center for Health Care Human Factors, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Hebden', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Cagla', 'Initials': 'C', 'LastName': 'Oruc', 'Affiliation': 'Armstrong Institute Center for Health Care Human Factors, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Lona', 'Initials': 'L', 'LastName': 'Mody', 'Affiliation': 'Division of Geriatric and Palliative Care Medicine, University of Michigan Medical School, Ann Arbor, Michigan.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Jacobs Slifka', 'Affiliation': 'Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Nimalie D', 'Initials': 'ND', 'LastName': 'Stone', 'Affiliation': 'Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Mary-Claire', 'Initials': 'MC', 'LastName': 'Roghmann', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland.'}]",Infection control and hospital epidemiology,['10.1017/ice.2020.1219'] 890,33078318,"Reducing Seroma Formation and Its Sequelae After Mastectomy by Closure of the Dead Space: A Multi-center, Double-Blind Randomized Controlled Trial (SAM-Trial).","BACKGROUND Seroma is a common complication after mastectomy, with an incidence of 3% to 85%. Seroma is associated with pain, delayed wound healing, and additional outpatient clinic visits, leading potentially to repeated seroma aspiration or even surgical interventions. This study aimed to assess the effect of flap fixation using sutures or tissue glue in preventing seroma formation and its sequelae. METHODS Between June 2014 and July 2018, 339 patients with an indication for mastectomy or modified radical mastectomy were enrolled in this randomized controlled trial in the Netherlands. Patients were randomly allocated to one of the three following arms: conventional wound closure (CON, n = 115), flap fixation using sutures (FFS, n = 111) or flap fixation using tissue glue (FFG, n = 113). The primary outcome was the need for seroma aspiration. The secondary outcomes were additional outpatient department visits, surgical-site infection, shoulder function and mobility, cosmesis, skin-dimpling, and postoperative pain scores. RESULTS Flap fixation after mastectomy leads to fewer seroma aspirations than conventional wound closure (CON 17.5% vs FFS 7.3% vs FFG 10.8%; p = 0.057), with a significant difference between flap fixation with sutures and conventional wound closure (odds ratio [OR], 0.37; 95% confidence interval [CI], 0.16-0.89; p = 0.025). Flap fixation has no significant negative effect on surgical-site infections, shoulder function and mobility, cosmesis, skin-dimpling, or postoperative pain. CONCLUSION Flap fixation using sutures leads to a significant reduction in aspirations of post-mastectomy seromas. The authors strongly advise surgeons to use sutures for flap fixation in patients undergoing mastectomy. (ClinicalTrials.gov no. NCT03305757). PREREGISTRATION The trial was registered after enrollment of the first participant. However, no specific explanation exists for this except that through the years more importance has been given to central trial registration. Our research team can ensure that after enrollment of the first participant, no changes were made to the trial, analysis plan, and/or study design.",2021,"Flap fixation has no significant negative effect on surgical-site infections, shoulder function and mobility, cosmesis, skin-dimpling, or postoperative pain. ","['Between June 2014 and July 2018', 'patients undergoing mastectomy', '339 patients with an indication for mastectomy or modified radical mastectomy']","['flap fixation using sutures or tissue glue', 'conventional wound closure (CON, n\u2009=\u2009115), flap fixation using sutures (FFS, n\u2009=\u2009111) or flap fixation using tissue glue (FFG, n\u2009=\u2009113', 'Flap fixation']","['seroma aspirations', 'pain, delayed wound healing, and additional outpatient clinic visits', 'flap fixation with sutures and conventional wound closure', 'need for seroma aspiration', 'surgical-site infections, shoulder function and mobility, cosmesis, skin-dimpling, or postoperative pain', 'Seroma Formation and Its Sequelae', 'additional outpatient department visits, surgical-site infection, shoulder function and mobility, cosmesis, skin-dimpling, and postoperative pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}]","[{'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0017780', 'cui_str': 'Glue'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C4517538', 'cui_str': '111'}]","[{'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0151692', 'cui_str': 'Impaired wound healing'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0243088', 'cui_str': 'sequels'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",339.0,0.27414,"Flap fixation has no significant negative effect on surgical-site infections, shoulder function and mobility, cosmesis, skin-dimpling, or postoperative pain. ","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'de Rooij', 'Affiliation': 'Department of Surgery, Zuyderland Medical Center, Sittard, The Netherlands. l.derooij@zuyderland.nl.'}, {'ForeName': 'S M J', 'Initials': 'SMJ', 'LastName': 'van Kuijk', 'Affiliation': 'Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'R W Y', 'Initials': 'RWY', 'LastName': 'Granzier', 'Affiliation': 'Department of Surgery, Zuyderland Medical Center, Sittard, The Netherlands.'}, {'ForeName': 'K F H', 'Initials': 'KFH', 'LastName': 'Hintzen', 'Affiliation': 'Department of Surgery, Zuyderland Medical Center, Sittard, The Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Heymans', 'Affiliation': 'Department of Surgery, Zuyderland Medical Center, Sittard, The Netherlands.'}, {'ForeName': 'L L B', 'Initials': 'LLB', 'LastName': 'Theunissen', 'Affiliation': 'Department of Surgery, Zuyderland Medical Center, Sittard, The Netherlands.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'von Meyenfeldt', 'Affiliation': 'Department of Surgery, Albert Schweitzer Hospital, Dordrecht, The Netherlands.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'van Essen', 'Affiliation': 'Department of Surgery, St. Jans Gasthuis Hospital, Weert, The Netherlands.'}, {'ForeName': 'E R M', 'Initials': 'ERM', 'LastName': 'van Haaren', 'Affiliation': 'Department of Surgery, Zuyderland Medical Center, Sittard, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Janssen', 'Affiliation': 'Department of Surgery, Zuyderland Medical Center, Sittard, The Netherlands.'}, {'ForeName': 'Y L J', 'Initials': 'YLJ', 'LastName': 'Vissers', 'Affiliation': 'Department of Surgery, Zuyderland Medical Center, Sittard, The Netherlands.'}, {'ForeName': 'G L', 'Initials': 'GL', 'LastName': 'Beets', 'Affiliation': 'Department of Surgery, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van Bastelaar', 'Affiliation': 'Department of Surgery, Zuyderland Medical Center, Sittard, The Netherlands.'}]",Annals of surgical oncology,['10.1245/s10434-020-09225-8'] 891,33078961,System providing automated feedback improves task learning outcomes during child restraint system (CRS) installations.,"OBJECTIVES The objective was to build and test an automated, interactive educational system to teach adults how to install a child restraint system (CRS) into a vehicle seat. METHODS The automated feedback system (AFS) consisted of a mockup vehicle fixture, convertible CRS, and doll. Sensors were implemented into the equipment so that forward-facing (FF) CRS installation errors could be detected. An interactive display monitor guided users through the CRS installation process and alerted them when steps were done incorrectly. Sixty adult volunteers were recruited and randomized into either the treatment group or the control group. The treatment group used the AFS to guide them through a practice installation. The control group also completed a practice installation using the same equipment fixture without the feedback feature turned on; they only had standard printed instruction manuals to guide their tasks. Then, participants from both groups completed a second CRS installation in a real vehicle with standard instruction manuals only. The frequencies and types of errors in all the installations were evaluated by a Child Passenger Safety Technician (CPST). Error rates were compared between the treatment and control groups using lower-tailed t-tests and Pearson's chi-square tests. Error rates were evaluated considering minor and serious errors together and also considering serious errors alone. RESULTS Compared to the control group, participants who trained with the AFS exhibited fewer overall errors (minor and serious) in their fixture installations (p < 0.0001) as well as their follow-up vehicle installations (p < 0.0001). Specifically, participants in the treatment group had fewer errors in choosing an installation method, locking the seat belt (SB), tightening the SB or lower anchors (LA), and tightening the harness (p = 0.0002, p = 0.0003, p = 0.0084, and p = 0.0098, respectively, compared to control group during follow-up vehicle installations). The treatment group also performed significantly better than the control group when only serious errors were considered. CONCLUSIONS An automated feedback system is an effective way to teach basic CRS installation skills to users.",2020,"Compared to the control group, participants who trained with the AFS exhibited fewer overall errors (minor and serious) in their fixture installations (p < 0.0001) as well as their follow-up vehicle installations (p < 0.0001).","['Sixty adult volunteers', 'child restraint system (CRS) installations']","['System providing automated feedback', 'practice installation using the same equipment fixture without the feedback feature turned on; they only had standard printed instruction manuals to guide their tasks']","['overall errors', 'Error rates', 'errors in choosing an installation method, locking the seat belt (SB), tightening the SB or lower anchors (LA), and tightening the harness', 'task learning outcomes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C2718030', 'cui_str': 'Child Restraint Systems'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0541749', 'cui_str': 'Does turn'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0036498', 'cui_str': 'Seat belt'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C3873748', 'cui_str': 'Harness'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",60.0,0.0470091,"Compared to the control group, participants who trained with the AFS exhibited fewer overall errors (minor and serious) in their fixture installations (p < 0.0001) as well as their follow-up vehicle installations (p < 0.0001).","[{'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Mansfield', 'Affiliation': 'Injury Biomechanics Research Center, School of Health and Rehabilitation Sciences, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Bolte', 'Affiliation': 'Injury Biomechanics Research Center, School of Health and Rehabilitation Sciences, The Ohio State University, Columbus, Ohio.'}]",Traffic injury prevention,['10.1080/15389588.2020.1829607'] 892,33083903,"Metasul vs Cerasul bearings: a prospective, randomized study at a mean eighteen years.","BACKGROUND The aims of our study were to compare the clinical, radiographic outcomes and survivals between second-generation metal-on-metal (Metasul) and ceramic-on-ceramic (Cerasul) bearings at a very long-term follow-up. METHODS A prospective, randomized study was originally performed on a consecutive series of 250 cementless, 28-mm head and primary total hip arthroplasties between 1999 and 2002. For each bearing (Metasul or Cerasul), 125 THAs were initially included. All cases were evaluated both clinically and radiographically, and survival was assessed, considering revisions for aseptic loosening or for any reason as the end points for failure. RESULTS At a mean 18-year follow-up, clinical and radiographic outcomes were similar. Harris Hip Score increased 30% in the Metasul group and 32% in the Cerasul group (p = 0.6). Survival free of aseptic loosening was higher for Cerasul (100%), than for Metasul (94% [CI 88-99.9]) (p = 0.04). Survival free of any revision was 91% ([CI 84-98%]) for Cerasul and 91% ([CI 84-98%]) for Metasul. Fractures of Cerasul insert occurred in four cases (3%) at a mean 12.5 ± 3.3 years (range, 6 to 17 years). CONCLUSION At 18 years, Cerasul demonstrated higher survivorship than Metasul considering aseptic loosening as an end point. However, Cerasul liners had high rate of fracture because of its sandwich design (thin ceramic liner into polyethylene). These implants are no more available on the market.",2020,"Survival free of aseptic loosening was higher for Cerasul (100%), than for Metasul (94% [CI 88-99.9]) (p = 0.04).","['mean eighteen years', 'consecutive series of 250 cementless, 28-mm head and primary total hip arthroplasties between 1999 and 2002']","['second-generation metal-on-metal (Metasul) and ceramic-on-ceramic (Cerasul) bearings', 'Metasul vs Cerasul bearings']","['Harris Hip Score', 'Fractures of Cerasul insert', 'Survival free of any revision', 'Survival free of aseptic loosening']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}]","[{'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0232920', 'cui_str': 'Sterile'}, {'cui': 'C0333050', 'cui_str': 'Loosening'}]",125.0,0.0378618,"Survival free of aseptic loosening was higher for Cerasul (100%), than for Metasul (94% [CI 88-99.9]) (p = 0.04).","[{'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Andeol', 'Affiliation': 'Hospices Civils de Lyon, Hôpital Lyon Sud, Service de Chirurgie Orthopédique et Traumatologique, 165 Chemin du Grand Revoyet, 69495, Pierre Bénite Cedex, France.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Viste', 'Affiliation': 'Hospices Civils de Lyon, Hôpital Lyon Sud, Service de Chirurgie Orthopédique et Traumatologique, 165 Chemin du Grand Revoyet, 69495, Pierre Bénite Cedex, France. anthony.viste@chu-lyon.fr.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Desmarchelier', 'Affiliation': 'Hospices Civils de Lyon, Hôpital Lyon Sud, Service de Chirurgie Orthopédique et Traumatologique, 165 Chemin du Grand Revoyet, 69495, Pierre Bénite Cedex, France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Lerat', 'Affiliation': 'Hospices Civils de Lyon, Hôpital Lyon Sud, Service de Chirurgie Orthopédique et Traumatologique, 165 Chemin du Grand Revoyet, 69495, Pierre Bénite Cedex, France.'}, {'ForeName': 'Michel-Henri', 'Initials': 'MH', 'LastName': 'Fessy', 'Affiliation': 'Hospices Civils de Lyon, Hôpital Lyon Sud, Service de Chirurgie Orthopédique et Traumatologique, 165 Chemin du Grand Revoyet, 69495, Pierre Bénite Cedex, France.'}]",International orthopaedics,['10.1007/s00264-020-04855-9'] 893,33085857,Efficacy of Tocilizumab in Patients Hospitalized with Covid-19.,"BACKGROUND The efficacy of interleukin-6 receptor blockade in hospitalized patients with coronavirus disease 2019 (Covid-19) who are not receiving mechanical ventilation is unclear. METHODS We performed a randomized, double-blind, placebo-controlled trial involving patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, hyperinflammatory states, and at least two of the following signs: fever (body temperature >38°C), pulmonary infiltrates, or the need for supplemental oxygen in order to maintain an oxygen saturation greater than 92%. Patients were randomly assigned in a 2:1 ratio to receive standard care plus a single dose of either tocilizumab (8 mg per kilogram of body weight) or placebo. The primary outcome was intubation or death, assessed in a time-to-event analysis. The secondary efficacy outcomes were clinical worsening and discontinuation of supplemental oxygen among patients who had been receiving it at baseline, both assessed in time-to-event analyses. RESULTS We enrolled 243 patients; 141 (58%) were men, and 102 (42%) were women. The median age was 59.8 years (range, 21.7 to 85.4), and 45% of the patients were Hispanic or Latino. The hazard ratio for intubation or death in the tocilizumab group as compared with the placebo group was 0.83 (95% confidence interval [CI], 0.38 to 1.81; P = 0.64), and the hazard ratio for disease worsening was 1.11 (95% CI, 0.59 to 2.10; P = 0.73). At 14 days, 18.0% of the patients in the tocilizumab group and 14.9% of the patients in the placebo group had had worsening of disease. The median time to discontinuation of supplemental oxygen was 5.0 days (95% CI, 3.8 to 7.6) in the tocilizumab group and 4.9 days (95% CI, 3.8 to 7.8) in the placebo group (P = 0.69). At 14 days, 24.6% of the patients in the tocilizumab group and 21.2% of the patients in the placebo group were still receiving supplemental oxygen. Patients who received tocilizumab had fewer serious infections than patients who received placebo. CONCLUSIONS Tocilizumab was not effective for preventing intubation or death in moderately ill hospitalized patients with Covid-19. Some benefit or harm cannot be ruled out, however, because the confidence intervals for efficacy comparisons were wide. (Funded by Genentech; ClinicalTrials.gov number, NCT04356937.).",2020,"CONCLUSIONS Tocilizumab was not effective for preventing intubation or death in moderately ill hospitalized patients with Covid-19.","['Patients Hospitalized with Covid-19', 'We enrolled 243 patients; 141 (58%) were men, and 102 (42%) were women', 'patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, hyperinflammatory states, and at least two of the following signs: fever (body temperature >38°C), pulmonary infiltrates, or the need for supplemental oxygen in order to maintain an oxygen saturation greater than 92', 'hospitalized patients with coronavirus disease 2019 (Covid-19) who are not receiving', 'moderately ill hospitalized patients with Covid-19', 'The median age was 59.8 years (range, 21.7 to 85.4), and 45% of the patients were Hispanic or Latino']","['mechanical ventilation', 'Tocilizumab', 'placebo', 'interleukin-6 receptor blockade', 'tocilizumab']","['intubation or death, assessed in a time-to-event analysis', 'clinical worsening and discontinuation of supplemental oxygen', 'worsening of disease', 'serious infections', 'hazard ratio for disease worsening', 'still receiving supplemental oxygen', 'median time to discontinuation of supplemental oxygen', 'hazard ratio for intubation or death', 'intubation or death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0235896', 'cui_str': 'Lung infiltration'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C5191366', 'cui_str': '21.7'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0063717', 'cui_str': 'Lymphocyte antigen CD126'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",243.0,0.755769,"CONCLUSIONS Tocilizumab was not effective for preventing intubation or death in moderately ill hospitalized patients with Covid-19.","[{'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Stone', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Frigault', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Naomi J', 'Initials': 'NJ', 'LastName': 'Serling-Boyd', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Ana D', 'Initials': 'AD', 'LastName': 'Fernandes', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Harvey', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Andrea S', 'Initials': 'AS', 'LastName': 'Foulkes', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Nora K', 'Initials': 'NK', 'LastName': 'Horick', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Healy', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Ruta', 'Initials': 'R', 'LastName': 'Shah', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Ana Maria', 'Initials': 'AM', 'LastName': 'Bensaci', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Ann E', 'Initials': 'AE', 'LastName': 'Woolley', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Nikiforow', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Lin', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Sagar', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Schrager', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Huckins', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Axelrod', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Pincus', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Fleisher', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Chana A', 'Initials': 'CA', 'LastName': 'Sacks', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dougan', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Crystal M', 'Initials': 'CM', 'LastName': 'North', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Yuan-Di', 'Initials': 'YD', 'LastName': 'Halvorsen', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Tara K', 'Initials': 'TK', 'LastName': 'Thurber', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Zeina', 'Initials': 'Z', 'LastName': 'Dagher', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Scherer', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Rachel S', 'Initials': 'RS', 'LastName': 'Wallwork', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Arthur Y', 'Initials': 'AY', 'LastName': 'Kim', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Schoenfeld', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Pritha', 'Initials': 'P', 'LastName': 'Sen', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Tomas G', 'Initials': 'TG', 'LastName': 'Neilan', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Cory A', 'Initials': 'CA', 'LastName': 'Perugino', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Sebastian H', 'Initials': 'SH', 'LastName': 'Unizony', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Deborah S', 'Initials': 'DS', 'LastName': 'Collier', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Matza', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Janeth M', 'Initials': 'JM', 'LastName': 'Yinh', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Bowman', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Meyerowitz', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Amna', 'Initials': 'A', 'LastName': 'Zafar', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Zsofia D', 'Initials': 'ZD', 'LastName': 'Drobni', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Marcy B', 'Initials': 'MB', 'LastName': 'Bolster', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Kohler', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': ""D'Silva"", 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Dau', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Lockwood', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Cubbison', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Brittany N', 'Initials': 'BN', 'LastName': 'Weber', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Mansour', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2028836'] 894,33108624,Telmisartan Plus S-Amlodipine Single-Pill Combination Therapy is Safe and Effective in Patients with Hypertension from Large-Scale Nationwide Surveillance Data in Korea (NOVEL) Study.,"INTRODUCTION We investigate the safety and efficacy of telmisartan plus S-amlodipine single-pill combination in a real-world population. METHODS A total of 44,715 patients who had hypertension and received a telmisartan/S-amlodipine single-pill combination at least once were included for safety and efficacy evaluation from 2852 primary to tertiary hospitals in Korea from August 2013 to December 2019. They were followed up for 3-6 months in terms of safety and efficacy of blood pressure (BP) lowering. RESULTS A total of 44,715 patients were included for safety analysis and 41,579 for efficacy analysis. Mean duration of taking the drug was 175.86 ± 48.45 days. A total of 28,096 (62.8%) patients were on telmisartan 40 mg plus S-amlodipine 2.5 mg combination followed by 80/2.5 mg (8664, 19.4%) and 40/5 mg of the drug (7136, 16.0%). Adverse events, total adverse drug reactions, and serious adverse drug reactions were found in 808 patients (1.81%), 352 (0.79%), and 1 (0.002%), respectively. Dizziness and headache were most common (134 [0.30%] and 81 [0.18%]) among all adverse events. Total edema and leg edema were rarely reported, 38 (0.08%) and 25 (0.06%), respectively. Systolic BP (SBP) and diastolic BP (DBP) was lowered from 143.1 ± 16.1/88.1 ± 11.8 mmHg to 129.6 ± 11.4/80.1 ± 9.0 mmHg (difference - 13.5/- 7.9 mmHg, P < 0.0001 for both). Target BP goal attainment rate defined as SBP < 140 mmHg and DBP < 90 mmHg was 74.6% (95% confidence interval [CI] 74.2-75.0) and BP response rate (defined as SBP < 140 mmHg or ≥ 20 mmHg reduction; DBP < 90 mmHg or ≥ 10 mmHg reduction) was 94.5% (95% CI 94.3-94.7). CONCLUSION Telmisartan plus S-amlodipine single-pill combination was safe and effective in patients with hypertension in a large real-world population.",2021,"Total edema and leg edema were rarely reported, 38 (0.08%) and 25 (0.06%), respectively.","['Patients with Hypertension from Large-Scale Nationwide Surveillance Data in Korea (NOVEL) Study', 'patients with hypertension in a large real-world population', '44,715 patients who had hypertension and received a', 'A total of 28,096 (62.8%) patients were on', '44,715 patients', 'from 2852 primary to tertiary hospitals in Korea from August 2013 to December 2019']","['telmisartan plus S-amlodipine single-pill combination', 'telmisartan/S-amlodipine single-pill combination', 'Telmisartan plus S-amlodipine single-pill combination', 'telmisartan 40\xa0mg plus S-amlodipine', 'Telmisartan Plus S-Amlodipine Single-Pill Combination Therapy']","['Total edema and leg edema', 'Adverse events, total adverse drug reactions, and serious adverse drug reactions', 'safety and efficacy of blood pressure (BP) lowering', 'safety and efficacy', 'Target BP goal attainment rate', 'BP response rate', 'safety and efficacy evaluation', 'Systolic BP (SBP) and diastolic BP (DBP', 'Dizziness and headache']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0990502', 'cui_str': 'telmisartan 40 MG'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0235886', 'cui_str': 'Leg edema'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0018681', 'cui_str': 'Headache'}]",44715.0,0.107475,"Total edema and leg edema were rarely reported, 38 (0.08%) and 25 (0.06%), respectively.","[{'ForeName': 'Sang-Ho', 'Initials': 'SH', 'LastName': 'Jo', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang-si, Gyeonggi-do, South Korea.'}, {'ForeName': 'Sung-Ji', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Department of Medicine, Cardiovascular Imaging Center, Samsung Medical Center, Heart Vascular Stroke Institute, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Geu-Ru', 'Initials': 'GR', 'LastName': 'Hong', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Yonsei University Severance Hospital, Seoul, South Korea.'}, {'ForeName': 'Sang Wook', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Cardiovascular-Arrhythmia Center, Chung-Ang University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Chang-Gyu', 'Initials': 'CG', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Korea University Guro Hospital, Seoul, South Korea. parkcg@kumc.or.kr.'}]",Advances in therapy,['10.1007/s12325-020-01533-5'] 895,33081982,"A plant-based meal affects thalamus perfusion differently than an energy- and macronutrient-matched conventional meal in men with type 2 diabetes, overweight/obese, and healthy men: A three-group randomized crossover study.","BACKGROUND & AIMS Reward circuitry in the brain plays a key role in weight regulation. We tested the effects of a plant-based meal on these brain regions. METHODS A randomized crossover design was used to test the effects of two energy- and macronutrient-matched meals: a vegan (V-meal) and a conventional meat (M-meal) on brain activity, gastrointestinal hormones, and satiety in participants with type 2 diabetes (T2D; n = 20), overweight/obese participants (O; n = 20), and healthy controls (H; n = 20). Brain perfusion was measured, using arterial spin labeling functional brain imaging; satiety was assessed using a visual analogue scale; and plasma concentrations of gut hormones were determined at 0 and 180 min. Repeated-measures ANOVA was used for statistical analysis. Bonferroni correction for multiple comparisons was applied. The Hedge's g statistic was used to measure the effect size for means of paired difference between the times (180-0 min) and meal types (M-V meal) for each group. RESULTS Thalamus perfusion was the highest in patients with T2D and the lowest in overweight/obese individuals (p = 0.001). Thalamus perfusion decreased significantly after ingestion of the M-meal in men with T2D (p = 0.04) and overweight/obese men (p = 0.004), and it decreased significantly after ingestion of the V-meal in healthy controls (p < 0.001; Group x Meal x Time: F = 3.4; p = 0.035). The effect size was -0.41 (95% CI, -1.14 to 0.31; p = 0.26) for men with diabetes; -0.72 (95% CI, -1.48 to 0.01; p = 0.05) for overweight/obese men; and 0.82 (95% CI, 0.09 to 1.59; p = 0.03) for healthy men. Postprandial secretion of active GLP-1 increased after the V-meal compared with the M-meal by 42% (95% CI 25-62%; p = 0.003) in men with T2D and by 41% (95% CI 24-61%; p = 0.002) in healthy controls. Changes in thalamus perfusion after ingestion of both test meals correlated with changes in satiety (r = +0.68; p < 0.01), fasting plasma insulin (r = +0.40; p < 0.01), C-peptide (r = +0.48; p < 0.01) and amylin (r = +0.55; p < 0.01), and insulin secretion at 5 mmol/l (r = +0.77; p < 0.05). CONCLUSIONS The higher postprandial GLP-1 secretion after the V-meal in men with T2D, with concomitant greater satiety and changes in thalamus perfusion, suggest a potential use of plant-based meals in addressing the key pathophysiologic mechanisms of food intake regulation. Trial registration ClinicalTrials.gov number, NCT02474147.",2021,"Thalamus perfusion decreased significantly after ingestion of the M-meal in men with T2D (p = 0.04) and overweight/obese men (p = 0.004), and it decreased significantly after ingestion of the V-meal in healthy controls (p < 0.001; Group x Meal x Time: F = ","['men with type 2 diabetes, overweight/obese, and healthy men', 'participants with type 2 diabetes (T2D; n\xa0=\xa020), overweight/obese participants (O; n\xa0=\xa020), and healthy controls (H; n\xa0=\xa020', 'men with diabetes;\xa0-0.72']","['plant-based meal', 'energy- and macronutrient-matched conventional meal', 'energy- and macronutrient-matched meals: a vegan (V-meal) and a conventional meat (M-meal']","['brain activity, gastrointestinal hormones, and satiety', 'visual analogue scale; and plasma concentrations of gut hormones', 'satiety', 'fasting plasma insulin', 'Thalamus perfusion', 'Brain perfusion', 'insulin secretion', 'higher postprandial GLP-1 secretion', 'Postprandial secretion of active GLP-1']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4517475', 'cui_str': '0.72'}]","[{'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0344353', 'cui_str': 'Vegan'}, {'cui': 'C0025017', 'cui_str': 'Meat'}]","[{'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0017182', 'cui_str': 'Gastrointestinal hormone'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0205177', 'cui_str': 'Active'}]",,0.0847429,"Thalamus perfusion decreased significantly after ingestion of the M-meal in men with T2D (p = 0.04) and overweight/obese men (p = 0.004), and it decreased significantly after ingestion of the V-meal in healthy controls (p < 0.001; Group x Meal x Time: F = ","[{'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Kahleova', 'Affiliation': 'Institute for Clinical and Experimental Medicine, Prague, Czech Republic; Physicians Committee for Responsible Medicine, Washington, DC, USA. Electronic address: hkahleova@pcrm.org.'}, {'ForeName': 'Jaroslav', 'Initials': 'J', 'LastName': 'Tintera', 'Affiliation': 'Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Lenka', 'Initials': 'L', 'LastName': 'Thieme', 'Affiliation': 'Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Veleba', 'Affiliation': 'Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Klementova', 'Affiliation': 'Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Kudlackova', 'Affiliation': 'Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Malinska', 'Affiliation': 'Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Olena', 'Initials': 'O', 'LastName': 'Oliyarnyk', 'Affiliation': 'Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Irena', 'Initials': 'I', 'LastName': 'Markova', 'Affiliation': 'Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Haluzik', 'Affiliation': 'Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Pavlovicova', 'Affiliation': 'Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hill', 'Affiliation': 'Institute of Endocrinology, Prague, Czech Republic.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Tura', 'Affiliation': 'Metabolic Unit, CNR Institute of Neuroscience, Padua, Italy.'}, {'ForeName': 'Terezie', 'Initials': 'T', 'LastName': 'Pelikanova', 'Affiliation': 'Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.10.005'] 896,33081983,Effect of nutritional support in patients with lower respiratory tract infection: Secondary analysis of a randomized clinical trial.,"BACKGROUND In polymorbid patients with bronchopulmonary infection, malnutrition is an independent risk factor for mortality. There is a lack of interventional data investigating whether providing nutritional support during the hospital stay in patients at risk for malnutrition presenting with lower respiratory tract infection lowers mortality. METHODS For this secondary analysis of a randomized clinical trial (EFFORT), we analyzed data of a subgroup of patients with confirmed lower respiratory tract infection from an initial cohort of 2028 patients. Patients at nutritional risk (Nutritional Risk Screening [NRS] score ≥3 points) were randomized to receive protocol-guided individualized nutritional support to reach protein and energy goals (intervention group) or standard hospital food (control group). The primary endpoint of this analysis was all-cause 30-day mortality. RESULTS We included 378 of 2028 EFFORT patients (mean age 74.4 years, 24% with COPD) into this analysis. Compared to usual care hospital nutrition, individualized nutritional support to reach caloric and protein goals showed a similar beneficial effect of on the risk of mortality in the subgroup of respiratory tract infection patients as compared to the main EFFORT trial (odds ratio 0.47 [95%CI 0.17 to 1.27, p = 0.136] vs 0.65 [95%CI 0.47 to 0.91, p = 0.011]) with no evidence of a subgroup effect (p for interaction 0.859). Effects were also similar among different subgroups based on etiology and type of respiratory tract infection and for other secondary endpoints. CONCLUSION This subgroup analysis from a large nutrition support trial suggests that patients at nutritional risk as assessed by NRS 2002 presenting with bronchopulmonary infection to the hospital likely have a mortality benefit from individualized inhospital nutritional support. The small sample size and limited statistical power calls for larger nutritional studies focusing on this highly vulnerable patient population. CLINICAL TRIAL REGISTRATION Registered under ClinicalTrials.gov Identifier no. NCT02517476.",2021,p = 0.011]) with no evidence of a subgroup effect (p for interaction 0.859).,"['Patients at nutritional risk (Nutritional Risk Screening [NRS] score ≥3 points', '378 of 2028 EFFORT patients (mean age 74.4 years, 24% with COPD) into this analysis', 'patients with confirmed lower respiratory tract infection from an initial cohort of 2028 patients', 'patients with lower respiratory tract infection', 'patients at risk for malnutrition presenting with lower respiratory tract infection lowers mortality']","['protocol-guided individualized nutritional support to reach protein and energy goals (intervention group) or standard hospital food (control group', 'nutritional support']","['etiology and type of respiratory tract infection', 'cause 30-day mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1268620', 'cui_str': 'At risk for nutritional problem'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0184549', 'cui_str': 'At risk for imbalanced nutrition, less than body requirements'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",2028.0,0.157558,p = 0.011]) with no evidence of a subgroup effect (p for interaction 0.859).,"[{'ForeName': 'Annic', 'Initials': 'A', 'LastName': 'Baumgartner', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; Medical Faculty of the University of Basel, Switzerland.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Hasenboehler', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; Medical Faculty of the University of Basel, Switzerland.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Cantone', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; Medical Faculty of the University of Basel, Switzerland.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Hersberger', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; Medical Faculty of the University of Basel, Switzerland.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Bargetzi', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; Medical Faculty of the University of Basel, Switzerland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bargetzi', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; Medical Faculty of the University of Basel, Switzerland.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Kaegi-Braun', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Tribolet', 'Affiliation': 'Internal Medicine, Spital Lachen, Switzerland; Department of Health Professions, Bern University of Applied Sciences, Bern, Switzerland.'}, {'ForeName': 'Filomena', 'Initials': 'F', 'LastName': 'Gomes', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; The New York Academy of Sciences, New York City, NY, USA.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Hoess', 'Affiliation': 'Internal Medicine, Kantonsspital Muensterlingen, Switzerland.'}, {'ForeName': 'Vojtech', 'Initials': 'V', 'LastName': 'Pavlicek', 'Affiliation': 'Internal Medicine, Kantonsspital Muensterlingen, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Bilz', 'Affiliation': 'Internal Medicine & Endocrinology/Diabetes, Kantonsspital St.Gallen, Switzerland.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Sigrist', 'Affiliation': 'Internal Medicine & Endocrinology/Diabetes, Kantonsspital St.Gallen, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Brändle', 'Affiliation': 'Internal Medicine & Endocrinology/Diabetes, Kantonsspital St.Gallen, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Henzen', 'Affiliation': 'Internal Medicine, Kantonsspital Luzern, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Thomann', 'Affiliation': 'Department of Internal Medicine, Buergerspital Solothurn, Switzerland.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Rutishauser', 'Affiliation': 'Internal Medicine, Kantonsspital Baselland, Switzerland.'}, {'ForeName': 'Drahomir', 'Initials': 'D', 'LastName': 'Aujesky', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rodondi', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland; Institute of Primary Health Care (BIHAM), University of Bern, Switzerland.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Donzé', 'Affiliation': ""Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland; Division of General Internal Medicine, Brigham and Women's Hospital, Boston, MA, USA; Department of Medicine, Neuchâtel Hospital Network, Neuchâtel, Switzerland.""}, {'ForeName': 'Zeno', 'Initials': 'Z', 'LastName': 'Stanga', 'Affiliation': 'Division of Diabetology, Endocrinology, Nutritional Medicine & Metabolism, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Mueller', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; Medical Faculty of the University of Basel, Switzerland.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Schuetz', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; Medical Faculty of the University of Basel, Switzerland. Electronic address: schuetzph@gmail.com.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.10.009'] 897,33086438,Ustekinumab is effective and safe for ulcerative colitis through 2 years of maintenance therapy.,"BACKGROUND The ongoing UNIFI long-term extension evaluates subcutaneous ustekinumab for moderate-to-severe ulcerative colitis (UC) from weeks 44 through 220. AIMS To assess efficacy (through week 92) and safety (through week 96) during the long-term extension METHODS: Overall, 399 responders to intravenous ustekinumab induction and who were randomised to maintenance therapy were treated in the long-term extension (115 received subcutaneous placebo, 141 received ustekinumab 90 mg every 12 weeks [q12w], and 143 received ustekinumab 90 mg q8w). Placebo treatment was discontinued at unblinding after week 44. Partial Mayo scores were collected every 12 weeks and at each dosing visit after unblinding. Safety was evaluated throughout. RESULTS Among all patients randomised in maintenance, symptomatic remission rates (stool frequency = 0/1; rectal bleeding = 0) at week 92 were, 64.5% and 67.6% in the ustekinumab q12w and q8w groups, respectively. Among randomised patients treated in the long-term extension, 78.7% and 83.2% of patients receiving q12w and q8w, respectively, attained symptomatic remission at week 92; >95% of patients in symptomatic remission at week 92 were corticosteroid-free. Both ustekinumab groups maintained efficacy through week 92. From weeks 44 to 96, adverse events (AEs) per hundred patient-years (PY) of follow-up for combined ustekinumab vs placebo were: 255.68 vs 267.93; serious AEs, 9.34 vs 12.69; malignancies (including non-melanoma skin cancers), 0.93 vs 1.49; and serious infections, 2.33 vs 2.99. One patient with multiple comorbidities who received one ustekinumab dose after dose adjusting from placebo experienced a fatal cardiac arrest. CONCLUSIONS The efficacy of ustekinumab in patients with UC was sustained through 92 weeks. No new safety signals were observed (ClinicalTrials.gov number, NCT02407236).",2020,"Among all patients randomised in maintenance, symptomatic remission rates (stool frequency = 0/1; rectal bleeding = 0) at week 92 were, 64.5% and 67.6% in the ustekinumab q12w and q8w groups, respectively.","['moderate-to-severe ulcerative colitis (UC) from weeks 44 through 220', 'patients with UC']","['subcutaneous placebo', 'Ustekinumab', 'ustekinumab', 'placebo', 'ustekinumab 90\xa0mg every 12\xa0weeks [q12w], and 143 received ustekinumab 90\xa0mg q8w', 'Placebo']","['Safety', 'serious infections', 'Partial Mayo scores', 'symptomatic remission rates', 'fatal cardiac arrest', 'new safety signals', 'symptomatic remission']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517573', 'cui_str': '143'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]",,0.361164,"Among all patients randomised in maintenance, symptomatic remission rates (stool frequency = 0/1; rectal bleeding = 0) at week 92 were, 64.5% and 67.6% in the ustekinumab q12w and q8w groups, respectively.","[{'ForeName': 'Remo', 'Initials': 'R', 'LastName': 'Panaccione', 'Affiliation': 'Calgary, AB, Canada.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Danese', 'Affiliation': 'Milan, Italy.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'La Jolla, CA, USA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': ""O'Brien"", 'Affiliation': 'Spring House, PA, USA.'}, {'ForeName': 'Yiying', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Spring House, PA, USA.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Spring House, PA, USA.'}, {'ForeName': 'Omoniyi J', 'Initials': 'OJ', 'LastName': 'Adedokun', 'Affiliation': 'Spring House, PA, USA.'}, {'ForeName': 'Ilia', 'Initials': 'I', 'LastName': 'Tikhonov', 'Affiliation': 'Spring House, PA, USA.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Targan', 'Affiliation': 'Los Angeles, CA, USA.'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Abreu', 'Affiliation': 'Miami, FL, USA.'}, {'ForeName': 'Tadakazu', 'Initials': 'T', 'LastName': 'Hisamatsu', 'Affiliation': 'Tokyo, Japan.'}, {'ForeName': 'Ellen J', 'Initials': 'EJ', 'LastName': 'Scherl', 'Affiliation': 'New York, NY, USA.'}, {'ForeName': 'Rupert W', 'Initials': 'RW', 'LastName': 'Leong', 'Affiliation': 'Concord, NSW, Australia.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Rowbotham', 'Affiliation': 'Auckland, New Zealand.'}, {'ForeName': 'Ramesh P', 'Initials': 'RP', 'LastName': 'Arasaradnam', 'Affiliation': 'Coventry, UK.'}, {'ForeName': 'Bruce E', 'Initials': 'BE', 'LastName': 'Sands', 'Affiliation': 'New York, NY, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Marano', 'Affiliation': 'Spring House, PA, USA.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.16119'] 898,33091586,Cognitive behavioral therapy for insomnia to enhance cognitive function and reduce the rate of Aβ deposition in older adults with symptoms of insomnia: A single-site randomized pilot clinical trial protocol.,"Lifestyle interventions to increase exercise and improve diet have been the focus of recent clinical trials to potentially prevent Alzheimer's disease (AD). However, despite the strong links between sleep disruptions, cognitive decline, and AD, sleep enhancement has yet to be targeted as a lifestyle intervention to prevent AD. A recent meta-analysis suggests that approximately 15% of AD may be prevented by an efficacious intervention aimed to reduce sleep disturbances and sleep disorders. Chronic insomnia is the most frequent sleep disorder occurring in at least 40% of older adults. Individuals with insomnia are more likely to be diagnosed with Alzheimer's Disease (AD) and demonstrate decline in cognitive function at long-term follow-up. AD is characterized by the accumulation of amyloid-β (Aβ) plaques and tau tangles in the brain, and growing evidence shows impaired sleep contributes to the accumulation of Aβ. An intervention aimed at improving insomnia may be a critical opportunity for primary prevention to slow cognitive decline and potentially delay the onset of AD. Cognitive behavioral therapy for insomnia (CBT-I) is an efficacious treatment for insomnia, but the use of CBT-I to improve cognitive function and potentially reduce the rate of Aβ accumulation has never been examined. Therefore, the objective of the proposed study is to examine the efficacy of CBT-I on improving cognitive function in older adults with symptoms of insomnia. An exploratory aim is to assess the effect of CBT-I on rate of Aβ accumulation.",2020,Individuals with insomnia are more likely to be diagnosed with Alzheimer's Disease (AD),"[""Individuals with insomnia are more likely to be diagnosed with Alzheimer's Disease (AD"", 'older adults with symptoms of insomnia']","['CBT-I', 'Cognitive behavioral therapy']","['rate of Aβ deposition', 'Chronic insomnia', 'cognitive function']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.0637426,Individuals with insomnia are more likely to be diagnosed with Alzheimer's Disease (AD),"[{'ForeName': 'Catherine F', 'Initials': 'CF', 'LastName': 'Siengsukon', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, United States of America. Electronic address: csiengsukon@kumc.edu.'}, {'ForeName': 'Eryen', 'Initials': 'E', 'LastName': 'Nelson', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Cierra', 'Initials': 'C', 'LastName': 'Williams-Cooke', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Ludwig', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Eber Silveira', 'Initials': 'ES', 'LastName': 'Beck', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Vidoni', 'Affiliation': ""University of Kansas Alzheimer's Disease Center, Fairway, KS, United States of America.""}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Mahnken', 'Affiliation': ""University of Kansas Alzheimer's Disease Center, Fairway, KS, United States of America; Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, KS, United States of America.""}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Stevens', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Drerup', 'Affiliation': 'Sleep Disorders Clinic, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Bruce', 'Affiliation': 'Department of Biomedical and Health Informatics, University of Missouri - Kansas City School of Medicine, Kansas City, MO, United States of America.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Burns', 'Affiliation': ""University of Kansas Alzheimer's Disease Center, Fairway, KS, United States of America.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106190'] 899,33094208,Minimizing Glucose Excursions (GEM) With Continuous Glucose Monitoring in Type 2 Diabetes: A Randomized Clinical Trial.,"This study aimed to compare conventional medication management of type 2 diabetes (T2D) to medication management in conjunction with a lifestyle intervention using continuous glucose monitoring to minimize glucose excursions. Thirty adults (63% female; mean age, 53.3 years) who were diagnosed with T2D for less than 11 years (mean, 5.6 years), had glycated A 1c (HbA 1c ) ≥ 7.0% (51 mmol/mol) (mean 8.8%, [73 mmol/mol]), and were not using insulin, were randomly assigned in a 1:2 ratio to routine care (RC) or 4 group sessions of glycemic excursion minimization plus real-time CGM (GEM CGM ). Assessments at baseline and 5 months included a physical exam, metabolic and lipid panels, a review of diabetes medications, and psychological questionnaires. For the week following assessments, participants wore a blinded activity monitor and completed 3 days of 24-hour dietary recall. A subgroup also wore a blinded CGM. GEM CGM participants significantly improved HbA 1c (from 8.9% to 7.6% [74-60 mmol/mol] compared with 8.8% to 8.7% [73-72 mmol/mol] for RC ( P  = .03). Additionally, GEM CGM reduced the need for diabetes medication ( P  = .01), reduced carbohydrate consumption ( P  = .009), and improved diabetes knowledge ( P  = .001), quality of life ( P  = .01) and diabetes distress ( P  = .02), and trended to more empowerment ( P  = .05) without increasing dietary fat, lipids, or hypoglycemia. Confirming our prior research, GEM CGM appears to be a safe, effective lifestyle intervention option for adults with suboptimally controlled T2D who do not take insulin.",2020,"Additionally, GEM CGM reduced the need for diabetes medication ( P  = .01), reduced carbohydrate consumption ( P  = .009), and improved diabetes knowledge ( P  = .001), quality of life ( P  = .01) and diabetes distress ( P  = .02), and trended to more empowerment ( P  = .05) without increasing dietary fat, lipids, or hypoglycemia.","['adults with suboptimally controlled T2D who do not take insulin', 'Type 2 Diabetes', 'Thirty adults (63% female; mean age, 53.3 years) who were diagnosed with T2D for less than 11 years (mean, 5.6 years), had glycated A 1c (HbA 1c )\u2005≥\u20057.0% (51 mmol/mol) (mean 8.8%, [73 mmol/mol]), and were not using insulin']","['GEM CGM', 'routine care (RC) or 4 group sessions of glycemic excursion minimization plus real-time CGM (GEM CGM ']","['diabetes knowledge', 'diabetes distress', 'physical exam, metabolic and lipid panels, a review of diabetes medications, and psychological questionnaires', 'HbA 1c', 'need for diabetes medication', 'dietary fat, lipids, or hypoglycemia', 'reduced carbohydrate consumption', 'quality of life', 'Minimizing Glucose Excursions (GEM']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4517794', 'cui_str': '5.6'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C4517882', 'cui_str': '8.8'}, {'cui': 'C0445107', 'cui_str': 'Not used'}]","[{'cui': 'C0445501', 'cui_str': 'Gem'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0200382', 'cui_str': 'Lipid panel'}, {'cui': 'C0699752', 'cui_str': 'Review of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0012171', 'cui_str': 'Dietary fat'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0445501', 'cui_str': 'Gem'}]",30.0,0.0359699,"Additionally, GEM CGM reduced the need for diabetes medication ( P  = .01), reduced carbohydrate consumption ( P  = .009), and improved diabetes knowledge ( P  = .001), quality of life ( P  = .01) and diabetes distress ( P  = .02), and trended to more empowerment ( P  = .05) without increasing dietary fat, lipids, or hypoglycemia.","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Cox', 'Affiliation': 'University of Virginia School of Medicine, Center for Behavioral Medicine Research, Charlottesville, Virginia.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Banton', 'Affiliation': 'University of Virginia School of Medicine, Center for Behavioral Medicine Research, Charlottesville, Virginia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Moncrief', 'Affiliation': 'University of Virginia School of Medicine, Center for Behavioral Medicine Research, Charlottesville, Virginia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Conaway', 'Affiliation': 'University of Virginia School of Medicine, Public Health Sciences, Charlottesville, VA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Diamond', 'Affiliation': 'University of Virginia School of Medicine, Center for Behavioral Medicine Research, Charlottesville, Virginia.'}, {'ForeName': 'Anthony L', 'Initials': 'AL', 'LastName': 'McCall', 'Affiliation': 'University of Virginia School of Medicine, Endocrinology and Metabolism, Charlottesville, VA.'}]",Journal of the Endocrine Society,['10.1210/jendso/bvaa118'] 900,33095030,"Randomized, Placebo-controlled Trial of Inhaled Treprostinil for Patients at Risk for Acute Respiratory Distress Syndrome.","Rationale: Inhaled treprostinil may improve oxygenation and have additional antiinflammatory effects in early acute hypoxemic respiratory failure, potentially preventing or reducing the severity of acute respiratory distress syndrome (ARDS). Objectives: To determine whether administration of inhaled treprostinil to patients at risk for ARDS is feasible, safe, and efficacious. Methods: We performed a double-blind, placebo-controlled, single-center randomized pilot trial at a quaternary care academic medical center. Patients with acute hypoxemia due to pneumonia or signs of low-pressure pulmonary edema with a unilateral or bilateral infiltrate on chest imaging and a 4 L/min supplemental oxygen requirement not requiring positive pressure ventilation were evaluated. Randomized patients received study drug or placebo (2:1 ratio). Treatment was initiated at 6 breaths every 4 hours and titrated up to 12 breaths. Subjects were maintained on treatment for 7 days and then tapered off over a period of 4 days. Study drug was stopped if positive pressure ventilation was required (invasive or noninvasive). Results: Fourteen patients were enrolled over a period of 31 months. Baseline characteristics were not significantly different between treatment groups with respect to age, sex, race, Acute Physiologic Assessment and Chronic Health Evaluation score, lung injury prediction score, or baseline mean oxygen saturation as measured by pulse oximetry (Sp O 2 ):fraction of inspired oxygen (Fi O 2 ) ratio. Trends in daily baseline and 30-minute postdose Sp O 2 :Fi O 2 ratio for all treatment points were not significantly different between placebo and treprostinil. Four patients required positive pressure ventilation in the treprostinil group versus one in the placebo group. Conclusions: Inhaled treprostinil administration is feasible in patients at risk for ARDS but was not associated with improvement in the Sp O 2 :Fi O 2 ratio relative to placebo. Drug-associated adverse events were not severe nor unexpected based on the known adverse effect profile of inhaled treprostinil. The clinical benefit of this intervention is unclear at this time in the absence of larger studies.Clinical trial registered with Clinicaltrials.gov (NCT02370095).",2021,"Baseline characteristics were not significantly different between treatment groups with respect to age, gender, race, APACHE score, LIPS score or baseline mean SaO2/FiO2 ratio.","['early acute hypoxemic respiratory failure', 'quaternary care academic medical center', 'Patients with acute hypoxemia due to pneumonia or signs of low-pressure pulmonary edema with a unilateral or bilateral infiltrate on chest imaging and a ≥ 4 liter per minute supplemental oxygen requirement but not requiring positive pressure ventilation', 'patients at risk for ARDS', 'Fourteen patients were enrolled over a period of 31 months', 'Patients at Risk for Acute Respiratory Distress Syndrome']","['Inhaled Treprostinil', 'placebo', 'inhaled treprostinil', 'treprostinil', 'Placebo']","['SaO2/FiO2 ratio', 'positive pressure ventilation']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C4039867', 'cui_str': 'Acute hypoxemic respiratory failure'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0034063', 'cui_str': 'Pulmonary edema'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C1531652', 'cui_str': 'Chest imaging'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C1145760', 'cui_str': 'Treprostinil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}]",14.0,0.73009,"Baseline characteristics were not significantly different between treatment groups with respect to age, gender, race, APACHE score, LIPS score or baseline mean SaO2/FiO2 ratio.","[{'ForeName': 'H James', 'Initials': 'HJ', 'LastName': 'Ford', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, and.'}, {'ForeName': 'Wayne H', 'Initials': 'WH', 'LastName': 'Anderson', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, and.'}, {'ForeName': 'Blair', 'Initials': 'B', 'LastName': 'Wendlandt', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, and.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bice', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, and.'}, {'ForeName': 'Agathe', 'Initials': 'A', 'LastName': 'Ceppe', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, and.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Lanier', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, and.'}, {'ForeName': 'Shannon S', 'Initials': 'SS', 'LastName': 'Carson', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, and.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.202004-374OC'] 901,33095934,"The effect of rational-emotive education on irrational thinking, subjective wellbeing and self-efficacy of typically developing students and social acceptance of disabled students.","AIM This study aimed to assess the effects of rational-emotive education on the rational thinking, subjective well-being and self-efficacy of typical students and their levels of social acceptance of disabled students in mainstream classrooms. BACKGROUND Rational-emotive education exercises can be important for eliminating typical students' problem behaviours, such as poor acceptance of disabled classmates, in mainstream classrooms. METHOD The study was conducted between 25 October 2017 and 17 January 2018 at two middle schools located in Ankara, Turkey. A quasi-experimental design and nonequivalent control group were used. The research sample consisted of 212 typical students and 16 disabled students from the middle schools. A socio-demographic questionnaire and the Irrational Beliefs Scale for Adolescents, Adolescent Subjective Well-being Scale, General Self-Efficacy Scale and Social Acceptance Scale were used to collect data. Students in the intervention group participated in a 12-week rational-emotive education programme. RESULTS The results showed that, for the students who took part in the rational emotive-education programme, there was a significant increase in subjective well-being, self-efficacy and social acceptance of peers with special needs, and a significant reduction in irrational beliefs, compared to those in the control group (p < 0.001). Social Validity Questionnaire, which was completed by the parents of the students with special needs to assess the social validity and the effects of the intervention, indicated that the rational-emotive education programme provided a positive classroom atmosphere, which positively affected the disabled students. CONCLUSIONS The study results supported previous findings on rational-emotive education, which has been adopted in Turkey and in the world as a humanistic approach. Rational-emotive education can be used in mental and school health nursing to increase social acceptance of the disabled students, and to eliminate their social-emotional problems, and to create a positive classroom atmosphere for all students.",2020,"The results showed that, for the students who took part in the rational emotive-education program, there was a significant increase in subjective well-being, self-efficacy, and social acceptance towards peers with special needs, and a significant reduction in irrational beliefs as compared to those in the control group (p<.001).","['212 typically developing students and 16 disabled students in the middle schools', 'mainstream classrooms', 'typical students and their levels of social acceptance toward disabled students in mainstream classrooms', 'October 25, 2017 and January 17, 2018 at two middle schools located in Ankara, Turkey', 'disabled students']","['Rational-Emotive Education', 'rational-emotive education', 'Rational-Emotive Education program']","['Socio-Demographic Questionnaire, Irrational Beliefs Scale for Adolescents, Adolescent Subjective Wellbeing Scale, General Self-Efficacy Scale, and Social Acceptance Scale', 'irrational thinking, subjective wellbeing, and self-efficacy', 'irrational beliefs', 'Social Validity Questionnaire', 'subjective well-being, self-efficacy, and social acceptance', 'rational thinking, subjective wellbeing, and self-efficacy']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0024500', 'cui_str': 'Mainstreaming (Education)'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0542058', 'cui_str': 'Irrational'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}]",212.0,0.0131742,"The results showed that, for the students who took part in the rational emotive-education program, there was a significant increase in subjective well-being, self-efficacy, and social acceptance towards peers with special needs, and a significant reduction in irrational beliefs as compared to those in the control group (p<.001).","[{'ForeName': 'Esma', 'Initials': 'E', 'LastName': 'Kabasakal', 'Affiliation': 'Faculty of Health Science, Ankara Yıldırım Beyazıt University, Ankara, Turkey.'}, {'ForeName': 'Oya Nuran', 'Initials': 'ON', 'LastName': 'Emiroğlu', 'Affiliation': 'Faculty of Nursing, Hacettepe University, Ankara, Türkey.'}]","Child: care, health and development",['10.1111/cch.12819'] 902,33095994,Transmission of Oscillatory Volumes into the Preterm Lung during Noninvasive High-Frequency Ventilation.,"Rationale: There is increasing evidence for a clinical benefit of noninvasive high-frequency oscillatory ventilation (nHFOV) in preterm infants. However, it is still unknown whether the generated oscillations are effectively transmitted to the alveoli. Objectives: To assess magnitude and regional distribution of oscillatory volumes (V Osc ) at the lung level. Methods: In 30 prone preterm infants enrolled in a randomized crossover trial comparing nHFOV with nasal continuous positive airway pressure, electrical impedance tomography recordings were performed. During nHFOV, the smallest amplitude to achieve visible chest wall vibration was used, and the frequency was set at 8 hertz. Measurements and Main Results: Thirty consecutive breaths during artifact-free tidal ventilation were extracted for each of the 228 electrical impedance tomography recordings. After application of corresponding frequency filters, Vt and V Osc were calculated. There was a signal at 8 and 16 Hz during nHFOV, which was not detectable during nasal continuous positive airway pressure, corresponding to the set oscillatory frequency and its second harmonic. During nHFOV, the mean (SD) V Osc /Vt ratio was 0.20 (0.13). Oscillations were more likely to be transmitted to the non-gravity-dependent (mean difference [95% confidence interval], 0.041 [0.025-0.058]; P  < 0.001) and right-sided lung (mean difference [95% confidence interval], 0.040 [0.019-0.061]; P  < 0.001) when compared with spontaneous Vt. Conclusions: In preterm infants, V Osc during nHFOV are transmitted to the lung. Compared with the regional distribution of tidal breaths, oscillations preferentially reach the right and non-gravity-dependent lung. These data increase our understanding of the physiological processes underpinning nHFOV and may lead to further refinement of this novel technique.",2021,"Oscillations were more likely to be transmitted to the non-gravity-dependent [mean difference (95% CI): 0.041 (0.025 to 0.058); p<0.001] and right-sided lung [mean difference (95% CI): 0.040 (0.019 to 0.061); p<0.001] when compared with spontaneous V T . ","['30 prone preterm infants enrolled', 'preterm infants']","['noninvasive high-frequency oscillatory ventilation (nHFOV', 'nHFOV with nasal continuous positive airway pressure (nCPAP), electrical impedance tomography (EIT) recordings']",['tidal volumes (V T ) and V Osc'],"[{'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0419017', 'cui_str': 'High frequency oscillatory ventilation'}, {'cui': 'C1258045', 'cui_str': 'nCPAP Ventilation'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}]","[{'cui': 'C0040210', 'cui_str': 'Tidal volume'}]",30.0,0.0586295,"Oscillations were more likely to be transmitted to the non-gravity-dependent [mean difference (95% CI): 0.041 (0.025 to 0.058); p<0.001] and right-sided lung [mean difference (95% CI): 0.040 (0.019 to 0.061); p<0.001] when compared with spontaneous V T . ","[{'ForeName': 'Vincent D', 'Initials': 'VD', 'LastName': 'Gaertner', 'Affiliation': 'Newborn Research, Department of Neonatology, University Hospital and University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Andreas D', 'Initials': 'AD', 'LastName': 'Waldmann', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Rostock University Medical Center, Rostock, Germany.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Davis', 'Affiliation': ""Newborn Research Centre and Neonatal Services, The Royal Women's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Bassler', 'Affiliation': 'Newborn Research, Department of Neonatology, University Hospital and University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'Springer', 'Affiliation': ""Department of Neonatology, University Children's Hospital, Tübingen, Germany; and.""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Thomson', 'Affiliation': 'The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Tingay', 'Affiliation': 'The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Christoph M', 'Initials': 'CM', 'LastName': 'Rüegger', 'Affiliation': 'Newborn Research, Department of Neonatology, University Hospital and University of Zürich, Zürich, Switzerland.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202007-2701OC'] 903,33097178,Comment on: Posterior Capsule Opacification With Two Hydrophobic Acrylic Intraocular Lenses: 3-Year Results of a Randomized Trial.,,2021,,[],['Posterior Capsule Opacification With Two Hydrophobic Acrylic Intraocular Lenses'],[],[],"[{'cui': 'C1444680', 'cui_str': 'Posterior capsule opacification'}, {'cui': 'C0598629', 'cui_str': 'Hydrophobicity'}, {'cui': 'C0440181', 'cui_str': 'Acrylic dental material'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}]",[],,0.0696872,,"[{'ForeName': 'Raimo', 'Initials': 'R', 'LastName': 'Tuuminen', 'Affiliation': 'Helsinki, Finland; Kotka, Finland.'}, {'ForeName': 'Jose I', 'Initials': 'JI', 'LastName': 'Belda', 'Affiliation': 'Alicante, Spain.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.08.017'] 904,33098171,Influence of surgical technique and timing of primary repair on interarch relationship in UCLP: A randomized clinical trial.,"OBJECTIVE To compare dental arch relationships in children with unilateral cleft lip and palate (UCLP) between two surgical techniques for repair of cleft lip/palate and two ages of palate repair. SETTINGS AND SAMPLE Dental models were taken for a group of 448 subjects at a mean age of 7 years and were evaluated by means of the Goslon Yardstick. The patients studied consisted of an initial group of 673 infants with complete UCLP randomized into 8 study groups according to lip repair procedures (Millard versus Spina techniques); palate repair procedures (von Langenbeck versus Furlow techniques); and palate repair timing (early: 9 to 12 months versus late: 15-18 months). METHODS Four surgeons performed all surgeries. Dependent variables included the following: lip repair technique, palate repair technique, age at time of palate repair and surgeon; with sex as an independent variable. The data were analysed using a general linear model (P < .05). RESULTS There were no significant differences for occlusal index scores as a function of lip or palate surgical technique, palatal repair timing and sex. Significant differences were found for occlusal index scores as a function of the surgeon. CONCLUSION Dental arch relationships were not influenced by lip and palatal repair techniques or patient age at palatal repair. The surgeon was the major factor that influenced the dental arch relationship outcome.",2021,"There were no significant differences for occlusal index scores as a function of lip or palate surgical technique, palatal repair timing and sex.","['448 subjects at a mean age of 7 years and were evaluated by means of the Goslon Yardstick', 'patients studied consisted of an initial group of 673 infants with complete UCLP randomized into 8 study groups according to', 'UCLP', 'Four surgeons performed all surgeries', 'children with unilateral cleft lip and palate (UCLP) between two surgical techniques for repair of cleft lip/palate and two ages of palate repair']","['surgical technique and timing of primary repair', 'lip repair procedures (Millard versus Spina techniques); palate repair procedures (von Langenbeck versus Furlow techniques); palate repair timing (early: 9 to 12 months versus late: 15 to 18 months']","['function of lip or palate surgical technique, palatal repair timing and sex', 'occlusal index scores', 'lip repair technique, palate repair technique, age at time of palate repair, and surgeon; with sex as an independent variable']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0158651', 'cui_str': 'Complete unilateral cleft lip'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0158646', 'cui_str': 'Cleft palate with cleft lip'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0192070', 'cui_str': 'Repair of cleft lip'}, {'cui': 'C0337358', 'cui_str': 'Repair of palate'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0192038', 'cui_str': 'Repair of lip'}, {'cui': 'C0337358', 'cui_str': 'Repair of palate'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0192038', 'cui_str': 'Repair of lip'}, {'cui': 'C0337358', 'cui_str': 'Repair of palate'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",673.0,0.0839157,"There were no significant differences for occlusal index scores as a function of lip or palate surgical technique, palatal repair timing and sex.","[{'ForeName': 'Terumi Okada', 'Initials': 'TO', 'LastName': 'Ozawa', 'Affiliation': 'Department of Orthodontics, Hospital of Rehabilitation of Craniofacial Anomalies, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'Jeniffer de Cassia Rillo', 'Initials': 'JCR', 'LastName': 'Dutka', 'Affiliation': 'Department of Speech-Language and Audiology, Bauru Dental School and Hospital for Rehabilitation of Craniofacial Anomalies, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Garib', 'Affiliation': 'Department of Orthodontics, Hospital of Rehabilitation of Craniofacial Anomalies, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'Rita C M C', 'Initials': 'RCMC', 'LastName': 'Lauris', 'Affiliation': 'Department of Orthodontics, Hospital of Rehabilitation of Craniofacial Anomalies, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'Araci Malagodi', 'Initials': 'AM', 'LastName': 'Almeida', 'Affiliation': 'Department of Orthodontics, Hospital of Rehabilitation of Craniofacial Anomalies, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'Telma Vidotto de Sousa', 'Initials': 'TVS', 'LastName': 'Brosco', 'Affiliation': 'Department of Plastic Surgery, Hospital for Rehabilitation of Craniofacial Anomalies, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'José Roberto P', 'Initials': 'JRP', 'LastName': 'Lauris', 'Affiliation': 'Department of Orthodontics, Bauru Dental School and Hospital for Rehabilitation of Craniofacial Anomalies, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'Calogero', 'Initials': 'C', 'LastName': 'Dolce', 'Affiliation': 'University of Florida College of Dentistry, Gainesville, FL, USA.'}, {'ForeName': 'Maria Inês', 'Initials': 'MI', 'LastName': 'Pegoraro-Krook', 'Affiliation': 'Department of Speech-Language and Audiology, Bauru Dental School and Hospital for Rehabilitation of Craniofacial Anomalies, University of São Paulo, Bauru, Brazil.'}]",Orthodontics & craniofacial research,['10.1111/ocr.12435'] 905,33099015,"Intervention to promote physical activation and improve sleep and response feeding in infants for preventing obesity early in life, the baby-act trial: Rationale and design.","Infant obesity is increasing in the US, particularly among Hispanics. Rapid weight gain during infancy increases the risk of obesity later in life and could be prevented through multi-modal interventions addressing multiple risk factors through population-level programs. OBJECTIVES 1) determine the extent to which the intervention, compared with the usual care control condition, improves healthy weight gain and specific behaviors (physical activity, sleep, diet) in the first year of life and 2) evaluate the cost of the intervention as a modification of the current WIC standard of care. METHODS The lifestyle intervention focuses on age-appropriate infant physical activation, healthy sleep and sedentary patterns, and response feeding, by improving parenting skills delivered through a combination of technology (web-platform and text messages) and phone counseling. It is being tested among caregivers of infant participants of the Puerto Rico WIC program through a cluster-randomized controlled trial in 14 WIC clinics in San Juan starting in pregnancy until the infant is 12 months of age. The main outcome is infant rate of weight gain at 12 months; secondary outcomes include objectively measured hours of infant movement, sedentary behaviors and sleep, diet quality score and response feeding behaviors. We are also recording fees, time and personnel involved in the intervention development, maintenance and dissemination. CONCLUSIONS If successful, the intervention could be incorporated as a 'best practice' through WIC policy as a means to strengthen obesity prevention efforts to improve minority health and eliminate health disparities among Hispanics and possibly other at-risk groups beyond the childhood period. Clinicaltrials.gov registration: NCT03517891.",2020,"OBJECTIVES 1) determine the extent to which the intervention, compared with the usual care control condition, improves healthy weight gain and specific behaviors (physical activity, sleep, diet) in the first year of life and 2) evaluate the cost of the intervention as a modification of the current WIC standard of care. ",['caregivers of infant participants of the Puerto Rico WIC program through a cluster-randomized controlled trial in 14 WIC clinics in San Juan starting in pregnancy until the infant is 12\u202fmonths of age'],"['healthy sleep and sedentary patterns, and response feeding, by improving parenting skills delivered through a combination of technology (web-platform and text messages) and phone counseling']","['infant rate of weight gain at 12\u202fmonths; secondary outcomes include objectively measured hours of infant movement, sedentary behaviors and sleep, diet quality score and response feeding behaviors', 'Rapid weight gain', 'healthy weight gain and specific behaviors (physical activity, sleep, diet']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}, {'cui': 'C4277516', 'cui_str': 'Special Supplemental Nutrition Program for Women, Infants, and Children (U.S.)'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",14.0,0.0627379,"OBJECTIVES 1) determine the extent to which the intervention, compared with the usual care control condition, improves healthy weight gain and specific behaviors (physical activity, sleep, diet) in the first year of life and 2) evaluate the cost of the intervention as a modification of the current WIC standard of care. ","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Campos', 'Affiliation': 'Dental and Craniofacial Genomics Core, Endocrinology Section School of Medicine, University of Puerto Rico, San Juan 00936-5067, Puerto Rico. Electronic address: maribel.campos@upr.edu.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Pomeroy', 'Affiliation': 'Clinical Research Center, Marshfield Clinic Research Institute, Marshfield Clinic Health System, Marshfield, WI, USA. Electronic address: pomeroyj@marshfieldclinic.org.'}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Mays', 'Affiliation': 'Biomedical Informatics Core, Puerto Rico Clinical and Translational Research Consortium, San Juan, Puerto Rico. Electronic address: mary.mays@upr.edu.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lopez', 'Affiliation': 'Sports and Leisure Management program and Adapted Physical Education program, School of Education, Metropolitan University, San Juan Puerto Rico. Electronic address: lopeza1@suagm.edu.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Palacios', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, Miami USA. Electronic address: cristina.palacios@fiu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106185'] 906,33100818,Electrostatic Precipitation in Low Pressure Laparoscopic Hysterectomy and Myomectomy.,"Background and Objective The purpose of this study was to evaluate the impact of using electrostatic precipitation to manage the surgical plume during low pressure laparoscopic gynecologic procedures. Methods This was a prospective, blinded, randomized controlled study of women with a clinical indication for laparoscopic hysterectomy (n = 30) or myomectomy (n = 5). Patients were randomized to either use electrostatic precipitation (EP) during the procedure, or not (No EP, hysterectomy group only). Results Low pressure surgery could be undertaken in 87% of hysterectomy cases (13/15) when using EP to manage the surgical plume, compared to only 53% (8/15) in the No EP group. Overall average rating of the visual field was excellent with EP vs fair for No EP. Average CO 2 consumption was reduced by 29% when using EP (16.7L vs 23.5L, p = 0.152). The average number of procedural pauses to vent smoke was lower with EP than the No EP group (1.5 per case vs. 3.7 per case, p = 0.005). Average procedure duration for the EP vs No EP group was 40.5 min vs. 46.9 min ( p  =   0.987). There were no measurable differences between groups for body temperature, end-tidal CO 2 , and discharge pain scores. In myomectomy, all five cases could be performed at low pressure, with an excellent visual field rating. Conclusion Electrostatic precipitation enhances low pressure laparoscopic hysterectomy and myomectomy. This was achieved by minimizing interruptions to surgery and exchange of CO 2 ; providing a clear visual field throughout the procedure; and eliminating surgical smoke at the site of origin.",2020,"The average number of procedural pauses to vent smoke was lower with EP than the No EP group (1.5 per case vs. 3.7 per case, p = 0.005).","['Low Pressure Laparoscopic Hysterectomy and Myomectomy', 'women with a clinical indication for laparoscopic hysterectomy (n\u2009=\u200930) or myomectomy (n\u2009=\u20095']","['Electrostatic precipitation', 'Electrostatic Precipitation', 'electrostatic precipitation (EP) during the procedure, or not (No EP, hysterectomy group only', 'electrostatic precipitation']","['average number of procedural pauses to vent smoke', 'Average CO 2 consumption', 'Average procedure duration', 'Overall average rating of the visual field', 'body temperature, end-tidal CO 2 , and discharge pain scores']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy'}, {'cui': 'C0195309', 'cui_str': 'Uterine myomectomy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}]","[{'cui': 'C0376534', 'cui_str': 'Electrostatics'}, {'cui': 'C0032932', 'cui_str': 'Precipitation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.0901288,"The average number of procedural pauses to vent smoke was lower with EP than the No EP group (1.5 per case vs. 3.7 per case, p = 0.005).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Levine', 'Affiliation': 'Department of Obstetrics and Gynecology, Mercy Hospital, 621 S. New Ballas Rd, St. Louis, Missouri.'}, {'ForeName': 'Gregory F', 'Initials': 'GF', 'LastName': 'Petroski', 'Affiliation': 'Biostatistics & Research Design Unit, University of Missouri - Columbia School of Medicine, 182C Galena Hall, Columbia, Missouri.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Haertling', 'Affiliation': 'Mercy Research, 3231 S. National Ave., Ste 210, Springfield, Missouri.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Beaudoin', 'Affiliation': 'Mercy Research, 615 S. New Ballas Rd, Ste 2010, St. Louis, Missouri.'}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/JSLS.2020.00051'] 907,33103789,TACO-BEL-3: a feasibility study and a retrospective audit of diuretics for patients receiving blood transfusion at ten hospitals.,"BACKGROUND AND OBJECTIVES Transfusion-associated circulatory overload (TACO) is the leading cause of transfusion-related morbidity and mortality. A recently completed pilot trial randomized patients to pre-transfusion furosemide versus placebo but had a slower than expected enrollment rate. We sought to determine whether the lack of recruitment was due to a paucity of eligible patients or excessively restrictive eligibility criteria. MATERIALS AND METHODS At 10 sites, eligible patients were retrospectively identified by first screening blood bank databases over one month for all transfusion episodes meeting trial inclusion criteria, defined as non-surgical patients receiving single RBC unit transfusions. The age threshold was decreased from 65 to 50 years. The first 10 patients meeting inclusion criteria then underwent detailed chart review for the exclusion criteria. The incidence of TACO and furosemide use was also recorded. RESULTS At the 10 sites, 11 969 red cell units were transfused over 1 month and 1356 met the inclusion criteria. Of the 100 charts reviewed, 60 (60%) had no exclusion criteria. Active bleeding was the most common reason for ineligibility. There were 813 eligible transfusion episodes. Of the eligible patients, 17 (28·3%) had evidence of congestive heart failure, and furosemide was prescribed in 24 (40%). Despite the use of a lower age threshold, three cases of TACO were detected with an incidence of 3%. CONCLUSION A large number of transfusion episodes met eligibility criteria. With a 3% incidence of TACO, 50% decrease through the use pre-transfusion furosemide and a target consent rate of 30%, a definitive trial of approximately 3000 patients could be completed within 1 year.",2021,"Of the 100 charts reviewed, 60 (60%) had no exclusion criteria.","['patients receiving blood transfusion at ten hospitals', 'At 10 sites, eligible patients were retrospectively identified by first screening blood bank databases over one month for all transfusion episodes meeting trial inclusion criteria, defined as non-surgical patients receiving single RBC unit transfusions', 'Of the 100 charts reviewed, 60 (60%) had no exclusion criteria', '10 patients meeting inclusion criteria then underwent detailed chart review for the exclusion criteria', 'eligible patients or excessively restrictive eligibility criteria', '813 eligible transfusion episodes']","['transfusion furosemide versus placebo', 'diuretics', 'TACO-BEL-3']","['congestive heart failure', 'Active bleeding', 'incidence of TACO and furosemide use']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0005770', 'cui_str': 'Blood Banks'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0541653', 'cui_str': 'Chart evaluation by healthcare professional'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}]","[{'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}]","[{'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",11969.0,0.156831,"Of the 100 charts reviewed, 60 (60%) had no exclusion criteria.","[{'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Khandelwal', 'Affiliation': 'Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Yulia', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Cserti-Gazdewich', 'Affiliation': 'Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Muntadhar', 'Initials': 'M', 'LastName': 'Al Moosawi', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Armali', 'Affiliation': 'Education and Safety in Transfusion (QUEST) Research Program, University of Toronto Quality in Utilization, Toronto, ON, Canada.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Arnold', 'Affiliation': 'Hamilton General Hospital, Hamilton, ON, Canada.'}, {'ForeName': 'Jeannie', 'Initials': 'J', 'LastName': 'Callum', 'Affiliation': 'Laboratory Medicine Program, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Dallas', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Lani', 'Initials': 'L', 'LastName': 'Lieberman', 'Affiliation': 'Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Pavenski', 'Affiliation': 'Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Rioux-Massé', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Montreal, PQ, Canada.""}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Shehata', 'Affiliation': 'Laboratory Medicine Program, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Shih', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Pendergrast', 'Affiliation': 'Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.'}]",Vox sanguinis,['10.1111/vox.12994'] 908,33118206,A brief positive psychological intervention prior to a potentially stressful task facilitates more challenge-like cardiovascular reactivity in high trait anxious individuals.,"When confronted with stress, anxious individuals tend to evaluate the demands of an upcoming encounter as higher than the available resources, thus, indicating threat evaluations. Conversely, evaluating available resources as higher than the demands signals challenge. Both types of evaluations have been related to specific cardiovascular response patterns with higher cardiac output relative to peripheral resistance indicating challenge and higher peripheral resistance relative to cardiac output signaling threat. The aim of this research was to evaluate whether a brief positive psychological exercise (best possible selves intervention) prior to a potentially stress-evoking task shifted the cardiovascular profile in trait anxious individuals from a threat to a challenge type. We randomly assigned 74 participants to either a best possible selves or a control exercise prior to performing a sing a song stress task and assessed their level of trait anxiety. Cardiac output (CO) and total peripheral resistance (TPR) were continuously recorded through baseline, preparation, stress task, and recovery, respectively, as well as self-reported affect. Trait anxiety was related to higher CO in the best possible selves group and lower CO in the control group. While high trait anxious individuals in the control group showed increasing TPR reactivity, they exhibited a nonsignificant change in the best possible selves group. Moreover, in the latter group a stress-related decrease in positive affect in high trait anxious participants was prevented. Findings suggest that concentrating on strengths and positive assets prior to a potentially stressful encounter could trigger a more adaptive coping in trait anxious individuals.",2021,Trait anxiety was related to higher CO in the best possible selves group and lower CO in the control group.,"['trait anxious individuals from a threat to a challenge type', 'high trait anxious individuals']","['positive psychological intervention', 'control exercise prior to performing a sing a song stress task', 'positive psychological exercise (best possible selves intervention']","['TPR reactivity', 'Cardiac output (CO) and total peripheral resistance (TPR', 'Trait anxiety']","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0234857', 'cui_str': 'Singing'}, {'cui': 'C0872005', 'cui_str': 'Songs'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",74.0,0.0288945,Trait anxiety was related to higher CO in the best possible selves group and lower CO in the control group.,"[{'ForeName': 'Andreas R', 'Initials': 'AR', 'LastName': 'Schwerdtfeger', 'Affiliation': 'Health Psychology Unit, Institute of Psychology, University of Graz, Graz, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rominger', 'Affiliation': 'Health Psychology Unit, Institute of Psychology, University of Graz, Graz, Austria.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Weber', 'Affiliation': 'Health Psychology Unit, Institute of Psychology, University of Graz, Graz, Austria.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Aluani', 'Affiliation': 'Health Psychology Unit, Institute of Psychology, University of Graz, Graz, Austria.'}]",Psychophysiology,['10.1111/psyp.13709'] 909,33119790,Regional vitamin C in Bier block reduces the incidence of CRPS-1 following distal radius fracture surgery.,"BACKGROUND Systemic vitamin C supplementation after wrist fracture has been suggested to reduce the incidence of complex regional pain syndrome (CRPS). This study aimed to evaluate the effect of regional vitamin C in Bier block in the early phase of fracture on CRPS occurrence following surgery for distal radius fractures. METHODS Seventy-four patients with isolated extra-articular distal radius fracture with the plan of fixation under Bier block were enrolled. Patients were assigned randomly into two groups: receiving either 500 mg vitamin C or sterile water as a Bier block adjuvant. Both groups received 500 mg of oral vitamin C for six weeks. The patients were evaluated for CRPS signs and symptoms at 2, 4, 6, and 12 weeks post-surgery. RESULTS The overall incidence of CRPS 12 weeks after surgery in the vitamin C group was significantly less than the controls (22.9% vs 45.5%, p = 0.04). Logistic regression analysis showed that the only significant contribution in predicting the incidence of CRPS came from the intervention variable (OR 0.26, CI95% 0.08-0.85; P = 0.027). CONCLUSIONS The findings suggest that adding vitamin C 500 mg to the local anesthetic in Bier block significantly reduces the incidence of CRPS following distal radius fractures.",2021,"The overall incidence of CRPS 12 weeks after surgery in the vitamin C group was significantly less than the controls (22.9% vs 45.5%, p = 0.04).","['Seventy-four patients with isolated extra-articular distal radius fracture with the plan of fixation under Bier block were enrolled', 'distal radius fracture surgery']","['Regional vitamin C', '500\xa0mg of oral vitamin C', '500\xa0mg vitamin C or sterile water as a Bier block adjuvant', 'regional vitamin C', 'vitamin C']","['overall incidence of CRPS', 'incidence of CRPS']","[{'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205135', 'cui_str': 'Extra-articular'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0580806', 'cui_str': 'Local anesthetic intravenous regional block'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0359299', 'cui_str': 'sterile water'}, {'cui': 'C0580806', 'cui_str': 'Local anesthetic intravenous regional block'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0458219', 'cui_str': 'Complex regional pain syndrome'}]",74.0,0.0662965,"The overall incidence of CRPS 12 weeks after surgery in the vitamin C group was significantly less than the controls (22.9% vs 45.5%, p = 0.04).","[{'ForeName': 'Mahzad', 'Initials': 'M', 'LastName': 'Alimian', 'Affiliation': 'Department of Anesthesiology, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Sobhani Eraghi', 'Affiliation': 'Department of Orthopaedics Surgery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyyed Alireza', 'Initials': 'SA', 'LastName': 'Chavoshizadeh', 'Affiliation': 'Department of Anesthesiology, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Masood', 'Initials': 'M', 'LastName': 'Mohseni', 'Affiliation': 'Department of Anesthesiology, Iran University of Medical Sciences, Tehran, Iran. Masood.mohseni@gmail.com.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Mousavi', 'Affiliation': 'Department of Sports Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Movassaghi', 'Affiliation': 'Department of Anesthesiology, Iran University of Medical Sciences, Tehran, Iran.'}]",European journal of orthopaedic surgery & traumatology : orthopedie traumatologie,['10.1007/s00590-020-02821-0'] 910,33119861,"Switching to Biosimilar SDZ-ADL in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: 48-Week Efficacy, Safety and Immunogenicity Results From the Phase III, Randomized, Double-Blind ADMYRA Study.","BACKGROUND Sandoz adalimumab SDZ-ADL (GP-2017) is an approved adalimumab biosimilar with similar efficacy and comparable safety and immunogenicity to reference adalimumab (ref-ADL) as confirmed by analytical, pharmacokinetic and confirmatory studies. ADMYRA, a phase III double-blind study, was conducted with an aim to generate efficacy, safety and immunogenicity comparability data in patients with moderate-to-severe rheumatoid arthritis (RA) having inadequate response to disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX). The study also evaluated an aspect of 'switching' reference product to the biosimilar in terms of efficacy, safety and immunogenicity up to Week 48. METHODS Eligible patients (N = 353) were randomized 1:1 to receive subcutaneous (sc) SDZ-ADL 40 mg (n = 177) or ref-ADL (n = 176) every other week from Week 0 to Week 24. At Week 24, all patients with at least a moderate response by Disease Activity Score-28 including high-sensitivity C-reactive protein (DAS28-CRP) in the SDZ-ADL group continued SDZ-ADL (n = 159), and in the ref-ADL group were switched to SDZ-ADL (n = 166), treated for up to 46 weeks. The primary endpoint was change in DAS28-CRP from baseline at Week 12. Other efficacy endpoints included proportion of patients with European League Against Rheumatism (EULAR) response, EULAR remission, Boolean remission, safety and immunogenicity. RESULTS The DAS28-CRP score changes from baseline at Week 12 were similar between SDZ-ADL (- 2.16) and ref-ADL (- 2.18) with a mean difference (95% CI) of 0.02 (- 0.24 to 0.27), which was within the pre-specified equivalence margin of ± 0.6. After switching treatment from ref-ADL to SDZ-ADL, the mean DAS28-CRP change was similar between the SDZ-ADL and 'ref-ADL/switched SDZ-ADL' group (- 3.09 vs - 3.05). The proportion of patients with good/moderate EULAR response was 69.2%/29.0% in the SDZ-ADL group and 68.0%/29.6% in the 'ref-ADL/switched SDZ-ADL' group. The proportion of patients in EULAR remission was 51.4% and 54.4% and in Boolean remission was 16.8% and 21.6% for SDZ-ADL and 'ref-ADL/switched SDZ-ADL' groups, respectively. The secondary endpoints were similar across the treatment groups. The incidence of adverse events (AEs) and injection-site reactions were low and similar between SDZ-ADL and 'ref-ADL/switched SDZ-ADL' groups (AEs 70.6% vs 68.8%, injection-site reactions 4.0% vs 6.3%), and most of these patients experienced AEs of mild or moderate severity. Antidrug antibodies were detected in 24.2% and 25.6% of patients treated with SDZ-ADL and 'ref-ADL/switched SDZ-ADL', respectively, from baseline to Week 48, of which 72.5% in SDZ-ADL and 79.1% in 'ref-ADL/switched SDZ-ADL' groups were neutralizing. CONCLUSIONS In patients with moderate-to-severe RA who had an inadequate response to DMARDs, SDZ-ADL demonstrated a similar efficacy and a comparable safety and immunogenicity profile to ref-ADL. Efficacy was sustained after switching from ref-ADL to SDZ-ADL with no impact on safety (NCT02744755).",2020,"The incidence of adverse events (AEs) and injection-site reactions were low and similar between SDZ-ADL and 'ref-ADL/switched SDZ-ADL' groups (AEs 70.6% vs 68.8%, injection-site reactions 4.0% vs 6.3%), and most of these patients experienced AEs of mild or moderate severity.","['patients with moderate-to-severe rheumatoid arthritis (RA) having inadequate response to disease-modifying anti-rheumatic drugs (DMARDs) including', 'Patients with Moderate-to-Severe Active Rheumatoid Arthritis', 'Eligible patients (N\u2009=\u2009353']","['Biosimilar SDZ-ADL', 'methotrexate (MTX', 'Sandoz adalimumab SDZ-ADL (GP-2017', 'subcutaneous (sc) SDZ-ADL 40\xa0mg (n\u2009=\u2009177) or ref-ADL', 'SDZ-ADL']","['proportion of patients in EULAR remission', 'efficacy, safety and immunogenicity', 'change in DAS28-CRP', 'proportion of patients with good/moderate EULAR response', 'efficacy, safety and immunogenicity comparability data', 'Antidrug antibodies', 'incidence of adverse events (AEs) and injection-site reactions', 'mean DAS28-CRP change', 'Efficacy', 'proportion of patients with European League Against Rheumatism (EULAR) response, EULAR remission, Boolean remission, safety and immunogenicity', 'DAS28-CRP score changes', 'Boolean remission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003191', 'cui_str': 'Antirheumatic agent'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0009326', 'cui_str': 'Collagen disease'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",353.0,0.0911073,"The incidence of adverse events (AEs) and injection-site reactions were low and similar between SDZ-ADL and 'ref-ADL/switched SDZ-ADL' groups (AEs 70.6% vs 68.8%, injection-site reactions 4.0% vs 6.3%), and most of these patients experienced AEs of mild or moderate severity.","[{'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Wiland', 'Affiliation': 'Department of Rheumatology and Internal Medicine, Medical University, Wroclaw, Poland. pwiland1@gmail.com.'}, {'ForeName': 'Sławomir', 'Initials': 'S', 'LastName': 'Jeka', 'Affiliation': 'Department of Rheumatology and Connective Tissue Diseases, University Hospital No. 2, Collegium Medicum UMK, Bydgoszcz, Poland.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Dokoupilová', 'Affiliation': 'MEDICAL PLUS s.r.o., University of Veterinary and Pharmaceutical sciences, Faculty of Pharmacy, Uherske Hradiste, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Brandt-Jürgens', 'Affiliation': 'Rheumatology Private Practice, Berlin, Germany.'}, {'ForeName': 'Juan Manuel', 'Initials': 'JM', 'LastName': 'Miranda Limón', 'Affiliation': 'RM Pharma Specialists, Mexico City, Mexico.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Cantalejo Moreira', 'Affiliation': 'Unidad de Reumatología, Hospital Universitario de Fuenlabrada, Fuenlabrada, Madrid, Spain.'}, {'ForeName': 'Raul Veiga', 'Initials': 'RV', 'LastName': 'Cabello', 'Affiliation': 'Hospital Central de la Defensa, Glorieta Ejército, 1, 28047, Madrid, Spain.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Jauch-Lembach', 'Affiliation': 'Global Clinical Development, Biopharmaceuticals, Hexal AG (A Sandoz Company), Holzkirchen, Germany.'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Thakur', 'Affiliation': 'Global Clinical Development, Biopharmaceuticals, Hexal AG (A Sandoz Company), Holzkirchen, Germany.'}, {'ForeName': 'Halimuniyazi', 'Initials': 'H', 'LastName': 'Haliduola', 'Affiliation': 'Global Clinical Development, Biopharmaceuticals, Hexal AG (A Sandoz Company), Holzkirchen, Germany.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Brueckmann', 'Affiliation': 'Global Medical Affairs, Biopharmaceutical, Hexal AG (A Sandoz Company), Holzkirchen, Germany.'}, {'ForeName': 'Norman B', 'Initials': 'NB', 'LastName': 'Gaylis', 'Affiliation': 'Arthritis and Rheumatic Disease Specialties, Aventura, FL, USA.'}]","BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy",['10.1007/s40259-020-00447-6'] 911,33121346,"A phase 1, randomized, placebo-controlled study to evaluate the safety and immunogenicity of an mRNA-based RSV prefusion F protein vaccine in healthy younger and older adults.","Respiratory Syncytial Virus (RSV) causes lower respiratory tract infections that can be severe and sometimes fatal. The risk for severe RSV infection is highest in infants and older adults. A safe and effective RSV vaccine for older adults represents a serious unmet medical need due to higher morbidity and mortality in this age group. In this randomized, partially double-blind, placebo-controlled, phase 1 dose-escalation study, we evaluated the safety, tolerability and immunogenicity of an investigational messenger ribonucleic acid (mRNA) vaccine encoding the RSV fusion protein (F) stabilized in the prefusion conformation. The study was conducted in healthy younger adults (ages ≥18 and ≤49 years) and healthy older adults (ages ≥60 and ≤79 years). Participants received mRNA-1777 (V171) or placebo as a single intramuscular dose. For each dose level, three sentinel participants were administered open-label mRNA-1777 (V171). Seventy-two younger adults were randomized and administered 25, 100, or 200 µg mRNA-1777 (V171) or placebo, and 107 older adults were randomized and administered 25, 100, 200 or 300 µg mRNA-1777 (V171) or placebo. Primary objectives were safety and tolerability and secondary objectives included humoral and cell-mediated immunogenicity. All dose levels of mRNA-1777 (V171) were generally well tolerated and no serious adverse events related to the vaccine were reported. Immunization with mRNA-1777 (V171) elicited a humoral immune response as measured by increases in RSV neutralizing antibody titers, serum antibody titers to RSV prefusion F protein, D25 competing antibody titers to RSV prefusion F protein, and cell-mediated immune responses to RSV-F peptides.",2021,All dose levels of mRNA-1777 (V171) were generally well tolerated and no serious adverse events related to the vaccine were reported.,"['older adults', 'healthy younger adults (ages ≥18 and ≤49\xa0years) and healthy older adults (ages ≥60 and ≤79\xa0years', 'healthy younger and older adults', ' and 107 older adults', 'infants and older adults', 'Seventy-two younger adults']","['mRNA-based RSV prefusion F protein vaccine', 'investigational messenger ribonucleic acid (mRNA) vaccine', 'placebo', 'mRNA-1777 (V171) or placebo']","['tolerated and no serious adverse events', 'safety, tolerability and immunogenicity', 'safety and tolerability and secondary objectives included humoral and cell-mediated immunogenicity', 'safety and immunogenicity']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4319632', 'cui_str': '72'}]","[{'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}]",3.0,0.190719,All dose levels of mRNA-1777 (V171) were generally well tolerated and no serious adverse events related to the vaccine were reported.,"[{'ForeName': 'Antonios O', 'Initials': 'AO', 'LastName': 'Aliprantis', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Shaw', 'Affiliation': 'Moderna, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Griffin', 'Affiliation': 'QPharm, Herston, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Farinola', 'Affiliation': 'CMAX, Adelaide, Australia.'}, {'ForeName': 'Radha A', 'Initials': 'RA', 'LastName': 'Railkar', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Sachs', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Christine J', 'Initials': 'CJ', 'LastName': 'Swenson', 'Affiliation': 'Moderna, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Moderna, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Kara S', 'Initials': 'KS', 'LastName': 'Cox', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Spellman', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Colleen J', 'Initials': 'CJ', 'LastName': 'Winstead', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Smolenov', 'Affiliation': 'Moderna, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Eseng', 'Initials': 'E', 'LastName': 'Lai', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Tal', 'Initials': 'T', 'LastName': 'Zaks', 'Affiliation': 'Moderna, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Espeseth', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Panther', 'Affiliation': 'Moderna, Inc., Cambridge, MA, USA.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2020.1829899'] 912,33123968,"Myelopreservation with Trilaciclib in Patients Receiving Topotecan for Small Cell Lung Cancer: Results from a Randomized, Double-Blind, Placebo-Controlled Phase II Study.","INTRODUCTION Multilineage myelosuppression is an acute toxicity of cytotoxic chemotherapy, resulting in serious complications and dose modifications. Current therapies are lineage specific and administered after chemotherapy damage has occurred. Trilaciclib is a cyclin-dependent kinase 4/6 inhibitor that is administered prior to chemotherapy to preserve hematopoietic stem and progenitor cells and immune system function during chemotherapy (myelopreservation). METHODS In this randomized, double-blind, placebo-controlled phase II trial, patients with previously treated extensive-stage small cell lung cancer (ES-SCLC) were randomized to receive intravenous trilaciclib 240 mg/m 2 or placebo before topotecan 1.5 mg/m 2 on days 1-5 of each 21-day cycle. Primary endpoints were duration of severe neutropenia (DSN) in cycle 1 and occurrence of severe neutropenia (SN). Additional endpoints were prespecified to further assess the effect of trilaciclib on myelopreservation, safety, patient-reported outcomes (PROs), and antitumor efficacy. RESULTS Thirty-two patients received trilaciclib, and 29 patients received placebo. Compared with placebo, administration of trilaciclib prior to topotecan resulted in statistically significant and clinically meaningful decreases in DSN in cycle 1 (mean [standard deviation] 2 [3.9] versus 7 [6.2] days; adjusted one-sided P < 0.0001) and occurrence of SN (40.6% versus 75.9%; adjusted one-sided P = 0.016), with numerical improvements in additional neutrophil, red blood cell, and platelet measures. Patients receiving trilaciclib had fewer grade ≥ 3 hematologic adverse events than patients receiving placebo, particularly neutropenia (75.0% versus 85.7%) and anemia (28.1% versus 60.7%). Myelopreservation benefits extended to improvements in PROs, specifically in those related to fatigue. Antitumor efficacy was comparable between treatment arms. CONCLUSIONS Compared with placebo, the addition of trilaciclib prior to topotecan for the treatment of patients with previously treated ES-SCLC improves the patient experience of receiving chemotherapy, as demonstrated by a reduction in chemotherapy-induced myelosuppression, improved safety profile, improved quality of life and no detrimental effects on antitumor efficacy. TRIAL REGISTRATION ClinicalTrials.gov: NCT02514447.",2021,"3 hematologic adverse events than patients receiving placebo, particularly neutropenia (75.0% versus 85.7%) and anemia (28.1% versus 60.7%).","['Patients Receiving Topotecan for Small Cell Lung Cancer', 'patients with previously treated extensive-stage small cell lung cancer (ES-SCLC']","['trilaciclib', 'placebo', 'intravenous trilaciclib 240\xa0mg/m 2 or placebo before topotecan 1.5\xa0mg/m 2', 'Myelopreservation with Trilaciclib', 'Placebo']","['occurrence of SN', 'duration of severe neutropenia (DSN) in cycle 1 and occurrence of severe neutropenia (SN', 'myelopreservation, safety, patient-reported outcomes (PROs), and antitumor efficacy', 'antitumor efficacy', 'anemia', 'safety profile, improved quality of life', 'neutropenia', '3 hematologic adverse events', 'Antitumor efficacy', 'additional neutrophil, red blood cell, and platelet measures', 'grade\u2009≥', 'DSN']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0146224', 'cui_str': 'Topotecan'}, {'cui': 'C0149925', 'cui_str': 'Small cell carcinoma of lung'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0278726', 'cui_str': 'Small cell lung cancer extensive stage'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0146224', 'cui_str': 'Topotecan'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0011195', 'cui_str': 'Déjérine-Sottas disease'}]",,0.542584,"3 hematologic adverse events than patients receiving placebo, particularly neutropenia (75.0% versus 85.7%) and anemia (28.1% versus 60.7%).","[{'ForeName': 'Lowell L', 'Initials': 'LL', 'LastName': 'Hart', 'Affiliation': 'Medical Oncology, Florida Cancer Specialists, Fort Myers, FL, USA. lhart@flcancer.com.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Ferrarotto', 'Affiliation': 'Department of Thoracic and Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Zoran G', 'Initials': 'ZG', 'LastName': 'Andric', 'Affiliation': 'Medical Oncology Department, Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia.'}, {'ForeName': 'J Thaddeus', 'Initials': 'JT', 'LastName': 'Beck', 'Affiliation': 'Department of Medical Oncology and Hematology, Highlands Oncology Group, Rogers, MI, USA.'}, {'ForeName': 'Janakiraman', 'Initials': 'J', 'LastName': 'Subramanian', 'Affiliation': ""Department of Medicine, Saint Luke's Hospital, Kansas City, MO, USA.""}, {'ForeName': 'Davorin Z', 'Initials': 'DZ', 'LastName': 'Radosavljevic', 'Affiliation': 'Institute for Oncology and Radiology of Serbia, Belgrade, Serbia.'}, {'ForeName': 'Bojan', 'Initials': 'B', 'LastName': 'Zaric', 'Affiliation': 'Faculty of Medicine, Institute for Pulmonary Diseases of Vojvodina, University of Novi Sad, Sremska Kamenica, Serbia.'}, {'ForeName': 'Wahid T', 'Initials': 'WT', 'LastName': 'Hanna', 'Affiliation': 'Hematology/Oncology, University of Tennessee Graduate School of Medicine, Knoxville, TN, USA.'}, {'ForeName': 'Raid', 'Initials': 'R', 'LastName': 'Aljumaily', 'Affiliation': 'Stephenson Cancer Center, University of Oklahoma, Oklahoma City, OK, USA.'}, {'ForeName': 'Taofeek K', 'Initials': 'TK', 'LastName': 'Owonikoko', 'Affiliation': 'Department of Hematology and Medical Oncology, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Verhoeven', 'Affiliation': 'Department of Medical Oncology, AZ Klina Brasschaat, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': 'G1 Therapeutics, Inc., Research Triangle Park, NC, USA.'}, {'ForeName': 'Shannon R', 'Initials': 'SR', 'LastName': 'Morris', 'Affiliation': 'G1 Therapeutics, Inc., Research Triangle Park, NC, USA.'}, {'ForeName': 'Joyce M', 'Initials': 'JM', 'LastName': 'Antal', 'Affiliation': 'G1 Therapeutics, Inc., Research Triangle Park, NC, USA.'}, {'ForeName': 'Maen A', 'Initials': 'MA', 'LastName': 'Hussein', 'Affiliation': 'Department of Oncology, Florida Cancer Specialists, Leesburg, FL, USA.'}]",Advances in therapy,['10.1007/s12325-020-01538-0'] 913,33128325,Trial of Rivaroxaban in AntiPhospholipid Syndrome (TRAPS): Two-year outcomes after the study closure.,"BACKGROUND Trial of Rivaroxaban in AntiPhospholipid Syndrome was a prospective randomized, open-label, noninferiority study conducted in 14 centers in Italy. Rivaroxaban was compared with warfarin for the prevention of thromboembolic events, major bleeding, and vascular death in high-risk, triple-positive patients with antiphospholipid syndrome. OBJECTIVE The aim of this paper is to report the events during the 2-year follow-up after the study closure. METHODS On January 28, 2018, the trial was prematurely stopped by adjudication and safety committee for an excess of events in the rivaroxaban group. Randomized patients were advised on trial results and those randomized to rivaroxaban were solicited to switch to warfarin. All 14 participating centers were asked and accepted to follow their patients for clinical events. This report describes the rate of events that occurred between January 28, 2018, and January 28, 2020. RESULTS Of 120 randomized patients, 115 were available for follow-up. Outcome events were two in six (33.3%) patients who remained on direct oral anticoagulants (DOACs) and six in 109 (5.7%) patients on warfarin (hazard ratio [HR] 6.9; 95% confidence interval [CI] 1.4-34.5, P = .018). The two patients on DOACs (one taking dabigatran and one taking rivaroxaban) suffered from thromboembolic events, whereas of the six patients with composite outcomes on warfarin, three had thromboembolic events (HR for thrombosis 13.3; 95% CI 2.2-79.9, P = .005). CONCLUSION These data further support the use of warfarin in high-risk patients with antiphospholipid syndrome.",2021,"Rivaroxaban was compared to warfarin for the prevention of thromboembolic events, major bleeding, and vascular death in high-risk triple-positive patients with antiphospholipid syndrome. ","['120 randomized patients', '14 centres in Italy', 'AntiPhospholipid Syndrome (TRAPS', 'high-risk patients with APS']","['rivaroxaban', 'Rivaroxaban', 'warfarin']","['thromboembolic events, major bleeding, and vascular death', 'thromboembolic events']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0085278', 'cui_str': 'Antiphospholipid syndrome'}, {'cui': 'C1275126', 'cui_str': 'TNF receptor-associated periodic fever syndrome (TRAPS)'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",120.0,0.0654754,"Rivaroxaban was compared to warfarin for the prevention of thromboembolic events, major bleeding, and vascular death in high-risk triple-positive patients with antiphospholipid syndrome. ","[{'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Pengo', 'Affiliation': 'Thrombosis Research Laboratory, Department of Cardiac Thoracic and Vascular Sciences, and Public Health, University of Padova, Padova, Italy.'}, {'ForeName': 'Ariela', 'Initials': 'A', 'LastName': 'Hoxha', 'Affiliation': 'Internal Medicine, San Bortolo Hospital, Vicenza, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Andreoli', 'Affiliation': 'Rheumatology and Clinical Immunology ASST-Spedali Civili di Brescia, Department of Clinical and Experimental Science, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Tincani', 'Affiliation': 'Rheumatology and Clinical Immunology ASST-Spedali Civili di Brescia, Department of Clinical and Experimental Science, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Silvestri', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Prisco', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Tiziana', 'Initials': 'T', 'LastName': 'Fierro', 'Affiliation': 'Section of Internal and Cardiovascular Medicine, Department of Medicine, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Gresele', 'Affiliation': 'Section of Internal and Cardiovascular Medicine, Department of Medicine, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Cafolla', 'Affiliation': 'Department of Translational and Precision Medicine and Hematology, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'De Micheli', 'Affiliation': 'UOS Haemostasis and Thrombosis - Internal Medicine, ASST, Lecco, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Ghirarduzzi', 'Affiliation': 'Angiology Unit, Department of Internal Medicine, Santa Maria Nuova Hospital, Reggio Emilia, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Tosetto', 'Affiliation': 'Hematology Department, San Bortolo Hospital, Vicenza, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Falanga', 'Affiliation': 'Department of Immunohematology and Transfusion Medicine and Hemostasis and Thrombosis Center, Hospital Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Martinelli', 'Affiliation': ""A. Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Testa', 'Affiliation': 'Hemostasis and Thrombosis Center, Laboratory Medicine Department, Azienda Socio-Sanitaria Territoriale, Cremona, Italy.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Barcellona', 'Affiliation': 'Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Gerosa', 'Affiliation': 'Clincal Rheumatology Unit, Research Center for Adult and Pediatric Diseases, Department of Clinical Sciences and Community Health, ASST Pini-CTO, University of Milan, Milan, Italy.'}, {'ForeName': 'Gentian', 'Initials': 'G', 'LastName': 'Denas', 'Affiliation': 'Thrombosis Research Laboratory, Department of Cardiac Thoracic and Vascular Sciences, and Public Health, University of Padova, Padova, Italy.'}]",Journal of thrombosis and haemostasis : JTH,['10.1111/jth.15158'] 914,33087584,Music Can Reduce the Need for Pharmacologic Conscious Sedation During Invasive Coronary Angiography.,"OBJECTIVES Opiates and benzodiazepines are commonly used during invasive coronary angiography (ICA) to address pain and anxiety. In the United States (US), these medications are used in more than 90% of such cases. The utility of these medications during ICA has not been addressed by the scientific societies. The goals of this study were to evaluate the impact of music on the use of opiates and benzodiazepines and levels of pain and anxiety in patients undergoing ICA. METHODS In this prospective pilot study, a total of 72 subjects undergoing elective ICA were randomized to receive planned pharmacologic standard conscious sedation (SCS), including opiates and/or benzodiazepines pre-ICA vs music plus opiates and/or benzodiazepines as needed. Pain and anxiety levels, as well as use of SCS medications, were monitored during the periprocedural period. RESULTS Baseline characteristics, including rates of anxiety, depression, and other psychiatric disorders, were similar between the SCS and music groups. The levels of pain and anxiety were relatively low and similar between the two cohorts during the peri-ICA period. There was a trend toward less frequent use of SCS medications in the music group (62.2% in the SCS group vs 40.0% in the music group; P=.06) and significantly less use of midazolam per case in the music group (0.68 mg in the SCS group vs 0.37 mg in the music group; P=.048). SCS medication use also differed significantly between the two operators. CONCLUSIONS Listening to patient-selected music during the peri-ICA period may reduce the need for pharmacologic conscious sedation without adversely affecting pain and anxiety levels.",2020,There was a trend toward less frequent use of SCS medications in the music group (62.2% in the SCS group vs 40.0% in the music group; P=.06) and significantly less use of midazolam per case in the music group (0.68 mg in the SCS group vs 0.37 mg in the music group; P=.048).,"['72 subjects undergoing elective ICA', 'patients undergoing ICA']","['benzodiazepines', 'planned pharmacologic standard conscious sedation (SCS), including opiates and/or benzodiazepines pre-ICA vs music plus opiates and/or benzodiazepines', 'invasive coronary angiography (ICA', 'SCS', 'midazolam']","['pain and anxiety', 'pain and anxiety levels', 'Pain and anxiety levels', 'SCS medications', 'rates of anxiety, depression, and other psychiatric disorders', 'Pharmacologic Conscious Sedation', 'levels of pain and anxiety']","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0079159', 'cui_str': 'Conscious sedation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0079159', 'cui_str': 'Conscious sedation'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",72.0,0.0630958,There was a trend toward less frequent use of SCS medications in the music group (62.2% in the SCS group vs 40.0% in the music group; P=.06) and significantly less use of midazolam per case in the music group (0.68 mg in the SCS group vs 0.37 mg in the music group; P=.048).,"[{'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Ebrahimi', 'Affiliation': 'Veterans Affairs Greater Los Angeles Healthcare System, 11301 Wilshire Blvd, mail code 111E, Los Angeles, CA 90073 USA. Ebrahimi@ucla.edu.'}, {'ForeName': 'A Laurie', 'Initials': 'AL', 'LastName': 'Shroyer', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dennis', 'Affiliation': ''}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Currier', 'Affiliation': ''}, {'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Lendvai Wischik', 'Affiliation': ''}]",The Journal of invasive cardiology,[] 915,33093013,Myofunctional Therapy App for Severe Apnea-Hypopnea Sleep Obstructive Syndrome: Pilot Randomized Controlled Trial.,"BACKGROUND Myofunctional therapy has demonstrated efficacy in treating sleep-disordered breathing. We assessed the clinical use of a new mobile health (mHealth) app that uses a smartphone to teach patients with severe obstructive sleep apnea-hypopnea syndrome (OSAHS) to perform oropharyngeal exercises. OBJECTIVE We conducted a pilot randomized trial to evaluate the effects of the app in patients with severe OSAHS. METHODS Forty patients with severe OSAHS (apnea-hypoxia index [AHI]>30) were enrolled prospectively and randomized into an intervention group that used the app for 90 sessions or a control group. Anthropometric measures, Epworth Sleepiness Scale (0-24), Pittsburgh Sleep Quality Index (0-21), Iowa Oral Performance Instrument (IOPI) scores, and oxygen desaturation index were measured before and after the intervention. RESULTS After the intervention, 28 patients remained. No significant changes were observed in the control group; however, the intervention group showed significant improvements in most metrics. AHI decreased by 53.4% from 44.7 (range 33.8-55.6) to 20.88 (14.02-27.7) events/hour (P<.001). The oxygen desaturation index decreased by 46.5% from 36.31 (27.19-43.43) to 19.4 (12.9-25.98) events/hour (P=.003). The IOPI maximum tongue score increased from 39.83 (35.32-45.2) to 59.06 (54.74-64.00) kPa (P<.001), and the IOPI maximum lip score increased from 27.89 (24.16-32.47) to 44.11 (39.5-48.8) kPa (P<.001). The AHI correlated significantly with IOPI tongue and lip improvements (Pearson correlation coefficient -0.56 and -0.46, respectively; both P<.001). The Epworth Sleepiness Scale score decreased from 10.33 (8.71-12.24) to 5.37 (3.45-7.28) in the app group (P<.001), but the Pittsburgh Sleep Quality Index did not change significantly. CONCLUSIONS Orofacial exercises performed using an mHealth app reduced OSAHS severity and symptoms, and represent a promising treatment for OSAHS. TRIAL REGISTRATION Spanish Registry of Clinical Studies AWGAPN-2019-01, ClinicalTrials.gov NCT04438785; https://clinicaltrials.gov/ct2/show/NCT04438785.",2020,IOPI maximum tongue score increased from 39.83 (35.32-45.2) to 59.06,"['Severe Apnea-Hypopnea Sleep Obstructive Syndrome', 'Forty patients with severe OSAHS (apnea-hypoxia index [AHI] >30', 'patients with severe obstructive sleep apnea-hypopnea syndrome (OSAHS', 'patients with severe OSAHS']","['Myofunctional Therapy App', 'Myofunctional therapy']","['Oxygen desaturation index', 'IOPI maximum tongue score', 'IOPI tongue and lip improvements', 'AHI', 'Pittsburgh Sleep Quality Index', 'IOPI maximum lip score', 'Epworth Sleepiness Scale score', 'Anthropometric measures, Epworth Sleepiness Scale (0-24), Pittsburgh Sleep Quality Index (0-21), and Iowa Oral Performance Instrument (IOPI) scores, and oxygen desaturation index']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4285910', 'cui_str': 'Obstructive sleep apnea hypopnea syndrome'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C0600516', 'cui_str': 'Oral Myotherapy'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C4706348', 'cui_str': 'ESS (Epworth Sleepiness Scale) score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}]",40.0,0.0974474,IOPI maximum tongue score increased from 39.83 (35.32-45.2) to 59.06,"[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': ""O'Connor-Reina"", 'Affiliation': 'Otorhinolaryngology Department, Hospital Quironsalud Marbella, Marbella, Spain.'}, {'ForeName': 'Jose Maria', 'Initials': 'JM', 'LastName': 'Ignacio Garcia', 'Affiliation': 'Pulmonology Department, Hospital Quironsalud Marbella, Marbella, Spain.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Rodriguez Ruiz', 'Affiliation': 'Pulmonology Department, Hospital Quironsalud Marbella, Marbella, Spain.'}, {'ForeName': 'Maria Del Carmen', 'Initials': 'MDC', 'LastName': 'Morillo Dominguez', 'Affiliation': 'Pulmonology Department, Hospital Quironsalud Marbella, Marbella, Spain.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Ignacio Barrios', 'Affiliation': 'Pulmonology Department, Hospital Quironsalud Marbella, Marbella, Spain.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Baptista Jardin', 'Affiliation': 'Otorhinolaryngology Department, Clinica Universitaria de Navarra, Pamplona, Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Casado Morente', 'Affiliation': 'Otorhinolaryngology Department, Hospital Quironsalud Marbella, Marbella, Spain.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Garcia Iriarte', 'Affiliation': 'Otorhinolaryngology Department, Hospital Universitario Virgen de Valme, Sevilla, Spain.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Plaza', 'Affiliation': 'Otorhinolaryngogy Department, Hospital Universitario de Fuenlabrada, Universidad Rey Juan Carlos, Madrid, Spain.'}]",JMIR mHealth and uHealth,['10.2196/23123'] 916,33096271,Pain sensitivity and autonomic nervous system parameters as predictors of dry eye symptoms after LASIK.,"PURPOSE Differences in pain processing and autonomic function among patients have been implicated in the development of chronic pain after surgery. This study was designed to evaluate whether pain and autonomic metrics predict severity of chronic dry eye (DE) symptoms after LASIK, as there is increasing evidence that DE symptoms may be manifestations of persistent post-operative ocular pain. METHODS Secondary analysis of prospective randomized clinical trial. Patients were treated with either pregabalin or placebo. As no significant differences in DE symptoms were detected by treatment allocation at six months, all participants were grouped together for the present analyses. Subjects were evaluated pre-LASIK with regard to evoked pain sensitivity (utilizing quantitative sensory testing), autonomic metrics and DE and ocular pain symptoms (via validated questionnaires). Measures of DE and ocular pain were assessed post-LASIK, and the Dry Eye Questionnaire 5 (DEQ5) score 6-months after surgery was the primary outcome of interest. RESULTS 43 individuals were randomized to pregabalin (n = 21) or placebo (n = 22). 42 completed the 6-month visit. Several baseline autonomic metrics correlated with 6-month post-operative DEQ5 scores, including lower systolic (r -0.37, p = 0.02) and diastolic blood pressure (r -0.32, p = 0.04). Ocular pain at 6 months was also negatively correlated with blood pressure (r -0.31, p = 0.047). The presence of painful aftersensations was a significant predictor of chronic DE symptoms at 6 months (mean DEQ5 scores: 8.0 ± 1.9 versus 5.0 ± 5.0, p = 0.009). CONCLUSIONS Heightened parasympathetic tone and prolonged pain sensitivity measured prior to surgery predicted greater DE symptom severity 6 months after LASIK. TRIAL REGISTRATION NCT02701764.",2021,"Heightened parasympathetic tone and prolonged pain sensitivity measured prior to surgery predicted greater DE symptom severity 6 months after LASIK. ","['43 individuals', 'dry eye symptoms after LASIK']","['pregabalin', 'placebo', 'pregabalin or placebo']","['DE and ocular pain', 'Ocular pain', 'blood pressure', 'Heightened parasympathetic tone and prolonged pain sensitivity', 'lower systolic', 'evoked pain sensitivity (utilizing quantitative sensory testing), autonomic metrics and DE and ocular pain symptoms (via validated questionnaires', 'DE symptoms', 'chronic DE symptoms', 'Dry Eye Questionnaire 5 (DEQ5) score 6-months', 'diastolic blood pressure']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0752094', 'cui_str': 'Laser assisted in situ keratomileusis'}]","[{'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0151827', 'cui_str': 'Pain in eye'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0442803', 'cui_str': 'Heightened'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0430838', 'cui_str': 'Quantitative sensory test'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",43.0,0.287792,"Heightened parasympathetic tone and prolonged pain sensitivity measured prior to surgery predicted greater DE symptom severity 6 months after LASIK. ","[{'ForeName': 'Alexandra E', 'Initials': 'AE', 'LastName': 'Levitt', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Galor', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami, Miami, FL, USA; Department of Ophthalmology, Miami Veterans Administration Medical Center, Miami, FL, USA. Electronic address: agalor@med.miami.edu.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Small', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami, Miami, FL, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Feuer', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Felix', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, University of Miami, Miami, FL, USA; Research Service, Miami Veterans Administration Medical Center, Miami, FL, USA.'}]",The ocular surface,['10.1016/j.jtos.2020.10.004'] 917,33107209,The effect of cardiac rehabilitation program on functional capacity and waist to hip ratio in patients with coronary artery disease: A clinical trial.,"AIMS This study aimed to determine the impact of cardiac rehabilitation programs on functional capacity and waist to hip ratio in coronary artery disease (CAD) patients. METHODS In this clinical trial study 70 CAD patients were selected using purposive sampling and based on inclusion criteria. The intervention consisted of a 12-week training and exercise program included walking sessions at home at least three times a week. The 6-min walk test (6MWT) was conducted to measure the functional capacity and waist to hip ratio (WHR), as the anthropometric index, in both groups before and after the intervention. Data were analyzed in SPSS 21 using independent t test, paired t test, and Chi-square test. RESULTS The mean distance traveled in the 6MWT was 297.30 m and 283.55 in intervention and control groups respectively before the intervention. After the intervention, this distance was 509.03 and 389.91 m in intervention and control groups respectively, suggesting a significant difference between the two groups (p < .001). The mean WHR was 0.8648 and 0.8403 in intervention and in control respectively before the intervention. After the intervention, this value became 0.7985 and 0.8555 in intervention and control groups respectively and showed significant difference (p < .001). CONCLUSIONS The cardiac rehabilitation program improved the ability of patients in the 6MWT and enhanced their functional capacity and reduced the mean WHR, which in turn evinces the improvement of the anthropometric index and mitigation of risk factors in CAD patients. So, healthcare providers can deploy such rehabilitation programs to empower patients, alleviate disease complications, and reduce individual and social costs of cardiovascular diseases.",2021,The mean distance traveled in the 6MWT was 297.30 m and 283.55 in intervention and control groups respectively before the intervention.,"['70 CAD patients were selected using purposive sampling and based on inclusion criteria', 'coronary artery disease (CAD) patients', 'patients with coronary artery disease']","['12-week training and exercise program included walking sessions', 'cardiac rehabilitation program', 'cardiac rehabilitation programs']","['mean WHR', 'mean distance traveled', 'functional capacity and waist to hip ratio (WHR', '6-min walk test (6MWT', 'anthropometric index and mitigation of risk factors', 'functional capacity and waist to hip ratio']","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0040802', 'cui_str': 'Travel'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]",70.0,0.0260125,The mean distance traveled in the 6MWT was 297.30 m and 283.55 in intervention and control groups respectively before the intervention.,"[{'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Sahabazi Deh Sokhteh', 'Affiliation': 'Nursing and Midwifery School, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Pishkar', 'Affiliation': 'Faculty member of Nursing and Midwifery School, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Rafizadeh', 'Affiliation': 'Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Yaghoubinia', 'Affiliation': 'Community Nursing Research Center, Zahedan University of Medical Sciences, Zahedan, Iran.'}]",Japan journal of nursing science : JJNS,['10.1111/jjns.12386'] 918,33105390,Blood Flow Restriction Combined with Electrical Stimulation Attenuates Thigh Muscle Disuse Atrophy.,"PURPOSE This study aimed to investigate the effects of blood flow restriction (BFR) combined with electrical muscle stimulation (EMS) on skeletal muscle mass and strength during a period of limb disuse. METHODS Thirty healthy participants (22 ± 3 yr; 23 ± 3 kg·m-2) were randomly assigned to control (CON; n = 10), BFR alone (BFR; n = 10), or BFR combined with EMS (BFR + EMS; n = 10). All participants completed unloading of a single leg for 14 d, with no treatment (CON), or while treated with either BFR or BFR + EMS (twice daily, 5 d·wk-1). BFR treatment involved arterial three cycles of 5-min occlusion using suprasystolic pressure, each separated by 5 min of reperfusion. EMS (6 s on, 15 s off; 200 μs; 60 Hz; 15% maximal voluntary contraction [MVC]) was applied continuously throughout the three BFR cycles. Quadriceps muscle mass (whole-thigh lean mass via dual-energy x-ray absorptiometry and vastus lateralis [VL] muscle thickness via ultrasound) and strength (via knee extension MVC) were assessed before and after the 14-d unloading period. RESULTS After limb unloading, whole-thigh lean mass decreased in the control group (-4% ± 1%, P < 0.001) and BFR group (-3% ± 2%, P = 0.001), but not in the BFR + EMS group (-0.3% ± 3%, P = 0.8). VL muscle thickness decreased in the control group (-4% ± 4%, P = 0.005) and was trending toward a decrease in the BFR group (-8% ± 11%, P = 0.07) and increase in the BFR + EMS group (+5% ± 10%, P = 0.07). Knee extension MVC decreased over time (P < 0.005) in the control group (-18% ± 15%), BFR group (-10% ± 13%), and BFR + EMS group (-18% ± 15%), with no difference between groups (P > 0.5). CONCLUSION Unlike BFR performed in isolation, BFR + EMS represents an effective interventional strategy to attenuate the loss of muscle mass during limb disuse, but it does not demonstrate preservation of strength.",2021,"VL muscle thickness decreased in the control group (-4 ± 4%; p = 0.005), and was trending toward a decrease in the BFR group (-8 ± 11%; p = 0.07) and increase in the BFR+EMS group (+5 ± 10%; p = 0.07).",['Thirty healthy participants (22 ± 3 years; 23 ± 3 kg·m'],"['no treatment (CON), or while treated with either BFR, or BFR+EMS', 'blood flow restriction (BFR) combined with electrical muscle stimulation (EMS', 'BFR combined with EMS (BFR+EMS', 'BFR alone', 'Blood Flow Restriction Combined with Electrical Stimulation']","['Quadriceps muscle mass (whole thigh lean mass via DEXA and Vastus Lateralis (VL) muscle thickness via ultrasound) and strength (via knee-extension maximal voluntary contraction (MVC', 'Knee-extension MVC', 'skeletal muscle mass and strength', 'VL muscle thickness', 'thigh lean mass']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}]",30.0,0.0235988,"VL muscle thickness decreased in the control group (-4 ± 4%; p = 0.005), and was trending toward a decrease in the BFR group (-8 ± 11%; p = 0.07) and increase in the BFR+EMS group (+5 ± 10%; p = 0.07).","[{'ForeName': 'Joshua T', 'Initials': 'JT', 'LastName': 'Slysz', 'Affiliation': 'The University of Guelph, Guelph, Ontario, CANADA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Boston', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'King', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Pignanelli', 'Affiliation': ''}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Power', 'Affiliation': ''}, {'ForeName': 'Jamie F', 'Initials': 'JF', 'LastName': 'Burr', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002544'] 919,33111977,The Effects of Clinical and Home-based Physiotherapy Programs in Secondary Head and Neck Lymphedema.,"OBJECTIVES/HYPOTHESIS To determine the effects of complex decongestive physiotherapy (CDP) and home programs on external lymphedema, staging of lymphedema, fibrosis, and three-dimensional (3D) surface scanning and volume evaluation in head and neck lymphedema. STUDY DESIGN A prospective randomized controlled study. METHODS Twenty-one patients were randomly divided into three groups: CDP (n:7), home program (n:7), and control (n:7). Assessment methods were applied at baseline and 4 weeks later for all groups. MD. Anderson Cancer Center Head and Neck Lymphedema Protocol was implemented to evaluate head and neck external lymphedema, staging of lymphedema, and fibrosis. A 3D scanner and a software were used to determine and calculate the volume of the head and neck region via 3D surface scanning. Head and neck external lymphedema and fibrosis assessment criteria were performed to evaluate visible soft tissue edema and the degree of stiffness. RESULTS The severity and volume of lymphedema decreased in the CDP program group (P < .05). Besides, external lymphedema and fibrosis at submental region were decreased in both CDP program and home program groups (P < .05). CONCLUSIONS While the benefits of home program are limited, a CDP program may be more effective in the management of lymphedema and fibrosis in patients diagnosed with head and neck cancer. The clinical trial registration number: NCT04286698, date: 02/25/2020, retrospectively registered. LEVEL OF EVIDENCE 4 Laryngoscope, 131:E1550-E1557, 2021.",2021,The severity and volume of lymphedema decreased in the CDP program group (P < .05).,"['Secondary Head and Neck Lymphedema', 'patients diagnosed with head and neck cancer', 'head and neck lymphedema', 'Twenty-one patients']","['complex decongestive physiotherapy (CDP', 'CDP (n:7), home program (n:7), and control (n:7', 'Clinical and Home-based Physiotherapy Programs']","['external lymphedema and fibrosis at submental region', 'severity and volume of lymphedema']","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C3715213', 'cui_str': '21'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0931905', 'cui_str': 'Submental triangle structure'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",21.0,0.0228025,The severity and volume of lymphedema decreased in the CDP program group (P < .05).,"[{'ForeName': 'Kadirhan', 'Initials': 'K', 'LastName': 'Ozdemir', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Izmir Bakircay University, Izmir, Turkey.'}, {'ForeName': 'Ilke', 'Initials': 'I', 'LastName': 'Keser', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Gazi University, Ankara, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Duzlu', 'Affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine, Gazi University, Ankara, Turkey.'}, {'ForeName': 'Ozge P', 'Initials': 'OP', 'LastName': 'Erpolat', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine, Gazi University, Ankara, Turkey.'}, {'ForeName': 'Uluc', 'Initials': 'U', 'LastName': 'Saranli', 'Affiliation': 'Department of Computer Engineering, Faculty of Engineering, Middle East Technical University, Ankara, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Tutar', 'Affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine, Gazi University, Ankara, Turkey.'}]",The Laryngoscope,['10.1002/lary.29205'] 920,33113161,Effect of hyoscine-N-butylbromide on labor duration among nullipara in a southwestern Nigerian teaching hospital: A randomized controlled trial.,"OBJECTIVE To assess the effectiveness of hyoscine-N-butylbromide on the duration of the first stage of labor among nulliparous women. METHODS A randomized double-blind placebo-controlled study among 126 nulliparous women admitted in the active phase of labor to a teaching hospital in Sagamu, Nigeria, from January to August 2018. Based on the inclusion criteria, women were recruited and randomized to the study or control group, and given intravenous hyoscine-N-butylbromide 20 mg (1 mL) or sterile water (1 mL), respectively, during the active phase. Labor progress and outcomes were compared between the groups. RESULTS The mean ± SD duration of active phase of first stage of labor was significantly shorter in the hyoscine-N-butylbromide group (324.9 ± 134.6 min) than in the control group (392.7 ± 119.6 min) (P = 0.004). The rate of cervical dilatation was 1.4 ± 0.8 cm/h in the hyoscine-N-butylbromide group and 1.0 ± 0.5 cm/h in the control group (P = 0.004). There were no significant differences in fetal heart rate, maternal vital signs, or Apgar scores between the two groups. CONCLUSION Hyoscine-N-butylbromide was found to be effective in shortening the duration of the first stage of labor without adverse outcomes for mother or neonate. The trial was registered with the Pan African Clinical trials Registry (PACTR), protocol number: PACTR201808146688942 (https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3532).",2021,Hyoscine-N-butylbromide was found to be effective in shortening the duration of the first stage of labor without adverse outcomes for mother or neonate.,"['nulliparous women', '126 nulliparous women admitted in the active phase of labor to a teaching hospital in Sagamu, Nigeria, from January to August 2018', 'labor duration among nullipara in a southwestern Nigerian teaching hospital']","['hyoscine-N-butylbromide 20\xa0mg (1\xa0mL) or sterile water', 'placebo', 'hyoscine-N-butylbromide', 'Hyoscine-N-butylbromide']","['fetal heart rate, maternal vital signs, or Apgar scores', 'mean\xa0±\xa0SD duration of active phase of first stage of labor', 'rate of cervical dilatation']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0566679', 'cui_str': 'Duration of labor'}, {'cui': 'C0028641', 'cui_str': 'Nulliparity'}, {'cui': 'C1556089', 'cui_str': 'Nigerians'}]","[{'cui': 'C0006519', 'cui_str': 'Scopolamine butylbromide'}, {'cui': 'C0359299', 'cui_str': 'sterile water'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018811', 'cui_str': 'Fetal heart rate'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0022871', 'cui_str': 'First stage of labor'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}]",126.0,0.242392,Hyoscine-N-butylbromide was found to be effective in shortening the duration of the first stage of labor without adverse outcomes for mother or neonate.,"[{'ForeName': 'Adeniyi K', 'Initials': 'AK', 'LastName': 'Akiseku', 'Affiliation': 'Department of Obstetrics and Gynaecology, Olabisi Onabanjo University, Ago Iwoye, Nigeria.'}, {'ForeName': 'Olusoji E', 'Initials': 'OE', 'LastName': 'Jagun', 'Affiliation': 'Department of Obstetrics and Gynaecology, Olabisi Onabanjo University Teaching Hospital, Sagamu, Nigeria.'}, {'ForeName': 'Adebayo A', 'Initials': 'AA', 'LastName': 'Akadri', 'Affiliation': 'Department of Obstetrics and Gynaecology, Babcock University Teaching Hospital, Ilishan-Remo, Nigeria.'}, {'ForeName': 'John O', 'Initials': 'JO', 'LastName': 'Imaralu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Babcock University Teaching Hospital, Ilishan-Remo, Nigeria.'}, {'ForeName': 'Adetola O', 'Initials': 'AO', 'LastName': 'Olatunji', 'Affiliation': 'Department of Obstetrics and Gynaecology, Olabisi Onabanjo University Teaching Hospital, Sagamu, Nigeria.'}, {'ForeName': 'Adewale O', 'Initials': 'AO', 'LastName': 'Sule-Odu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Olabisi Onabanjo University Teaching Hospital, Sagamu, Nigeria.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13444'] 921,33113295,SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19.,"BACKGROUND Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (Covid-19), which is most frequently mild yet can be severe and life-threatening. Virus-neutralizing monoclonal antibodies are predicted to reduce viral load, ameliorate symptoms, and prevent hospitalization. METHODS In this ongoing phase 2 trial involving outpatients with recently diagnosed mild or moderate Covid-19, we randomly assigned 452 patients to receive a single intravenous infusion of neutralizing antibody LY-CoV555 in one of three doses (700 mg, 2800 mg, or 7000 mg) or placebo and evaluated the quantitative virologic end points and clinical outcomes. The primary outcome was the change from baseline in the viral load at day 11. The results of a preplanned interim analysis as of September 5, 2020, are reported here. RESULTS At the time of the interim analysis, the observed mean decrease from baseline in the log viral load for the entire population was -3.81, for an elimination of more than 99.97% of viral RNA. For patients who received the 2800-mg dose of LY-CoV555, the difference from placebo in the decrease from baseline was -0.53 (95% confidence interval [CI], -0.98 to -0.08; P = 0.02), for a viral load that was lower by a factor of 3.4. Smaller differences from placebo in the change from baseline were observed among the patients who received the 700-mg dose (-0.20; 95% CI, -0.66 to 0.25; P = 0.38) or the 7000-mg dose (0.09; 95% CI, -0.37 to 0.55; P = 0.70). On days 2 to 6, the patients who received LY-CoV555 had a slightly lower severity of symptoms than those who received placebo. The percentage of patients who had a Covid-19-related hospitalization or visit to an emergency department was 1.6% in the LY-CoV555 group and 6.3% in the placebo group. CONCLUSIONS In this interim analysis of a phase 2 trial, one of three doses of neutralizing antibody LY-CoV555 appeared to accelerate the natural decline in viral load over time, whereas the other doses had not by day 11. (Funded by Eli Lilly; BLAZE-1 ClinicalTrials.gov number, NCT04427501.).",2021,"On days 2 to 6, the patients who received LY-CoV555 had a slightly lower severity of symptoms than those who received placebo.","['outpatients with recently diagnosed mild or moderate Covid-19, we randomly assigned 452 patients to receive a', 'Outpatients with Covid-19']","['placebo', 'single intravenous infusion of neutralizing antibody LY-CoV555']","['severity of symptoms', 'viral load', 'Covid-19-related hospitalization or visit to an emergency department']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]",452.0,0.572537,"On days 2 to 6, the patients who received LY-CoV555 had a slightly lower severity of symptoms than those who received placebo.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Nirula', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Heller', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Gottlieb', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Boscia', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Morris', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Huhn', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Cardona', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Bharat', 'Initials': 'B', 'LastName': 'Mocherla', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Stosor', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Imad', 'Initials': 'I', 'LastName': 'Shawa', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Adams', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Van Naarden', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Kenneth L', 'Initials': 'KL', 'LastName': 'Custer', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Durante', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Oakley', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Schade', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Janelle', 'Initials': 'J', 'LastName': 'Sabo', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Dipak R', 'Initials': 'DR', 'LastName': 'Patel', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Klekotka', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Skovronsky', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2029849'] 922,33124762,The evaluation of the correct use and ease-of use of the ELLIPTA DPI in children with asthma.,"RATIONALE Asthma studies show many children use inhalers incorrectly even after instruction. For two age groups of children with asthma, we determined the proportions who used the once-daily ELLIPTA dry-powder inhaler (DPI) correctly, and who found it easy to use. METHODS This was a multicenter, single-arm, stratified, open-label, placebo study (NCT03478657). Children aged 5-7 and 8-11 years were trained in, and required to demonstrate, correct placebo ELLIPTA DPI use at their first clinic visit. The inhaler was used at home once daily for 28 ± 2 days. On returning to the clinic, children were randomized to an age-appropriate, ease-of-use questionnaire that had been developed and validated previously, and which rated the inhaler as ""easy"" or ""hard"" to use. Following questionnaire completion, children were then asked to demonstrate correct inhaler use. Correct use and ease-of use were assessed in each age group (co-primary endpoints) and overall (secondary endpoints). RESULTS Of 222 enrolled children, 221 completed the study. Among children aged 5-7 years, 92% (n = 81/88) demonstrated correct ELLIPTA use on their first attempt, compared with 93% (n = 124/133) aged 8-11 years. Of these children, 98% (5-7 years: n = 79/81; 8-11 years: n = 121/124) rated the inhaler easy to use. Overall, 93% (n = 205/221) demonstrated correct inhaler use on their first attempt, and 98% (n = 200/205) rated it easy to use. CONCLUSION ELLIPTA DPI was used correctly and easily by most children on their first attempt without additional training.",2021,"Overall, 93% (n = 205/221) demonstrated correct inhaler use on their first attempt, and 98% (n = 200/205) rated it easy to use. ","['Of 222', 'children with asthma', 'children aged 5-7 years, 92% (n = 81/88) demonstrated correct ELLIPTA use on their first attempt, compared to 93% (n = 124/133) aged 8-11 years', 'Children aged 5-7 and 8-11 years', 'enrolled children, 221 completed the study']","['ELLIPTA DPI', 'placebo ELLIPTA DPI']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1967611', 'cui_str': 'Dry powder inhaler'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],222.0,0.0380348,"Overall, 93% (n = 205/221) demonstrated correct inhaler use on their first attempt, and 98% (n = 200/205) rated it easy to use. ","[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Halverson', 'Affiliation': 'Allergy and Asthma Specialists, P.A., Minneapolis, Minnesota, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Liem', 'Affiliation': 'Joel Liem Medicine Professional Corporation, Windsor, Ontario, Canada.'}, {'ForeName': 'Logan', 'Initials': 'L', 'LastName': 'Heyes', 'Affiliation': 'GlaxoSmithKline plc, Stockley Park, UK.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Preece', 'Affiliation': 'GlaxoSmithKline plc, Stockley Park, UK.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Bareille', 'Affiliation': 'GlaxoSmithKline plc, Stevenage, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Rees', 'Affiliation': 'GlaxoSmithKline plc, Stockley Park, UK.'}, {'ForeName': 'Renu', 'Initials': 'R', 'LastName': 'Jain', 'Affiliation': 'GlaxoSmithKline plc, North Carolina, USA.'}, {'ForeName': 'Richard H', 'Initials': 'RH', 'LastName': 'Stanford', 'Affiliation': 'GlaxoSmithKline plc, North Carolina, USA.'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Lenney', 'Affiliation': 'GlaxoSmithKline plc, London, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Collison', 'Affiliation': 'GlaxoSmithKline plc, North Carolina, USA.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'GlaxoSmithKline plc, London, UK.'}]",Pediatric pulmonology,['10.1002/ppul.25149'] 923,33126555,"Impact of Physical Activity and Weight Loss on Fat Mass, Glucose Metabolism, and Inflammation in Older African Americans with Osteoarthritis.","(1) Background: There are currently very few interventions performed within a community setting that compare the effects of physical activity (PA) versus PA plus weight loss on cancer and chronic disease risk in older African Americans. Therefore, we investigated the impact of an 8 week (24 session) PA intervention compared to a PA plus weight loss intervention on fat mass, glucose metabolism, and markers of inflammation in older, overweight and obese African Americans. (2) Methods: Subjects were randomized to a PA ( n = 83) or PA plus weight loss ( n = 72) intervention that met three times weekly for 8 weeks. At baseline and post-intervention, anthropometrics, body composition, systemic inflammation (high-sensitivity C-reactive protein, tumor necrosis factor-α, and interleukin 6), fasting glucose, insulin and homeostasis model assessment-insulin resistance (HOMA-IR) were determined. (3) Results: Subjects had a mean age of 67 years (SD = 5.3) and were mostly women (88%). The PA plus weight loss group lost more total and visceral fat than the PA group (-4.0% vs. +0.6% and -4.1% vs. +3.7%, respectively, p < 0.01 for both). Changes in inflammation and glucose metabolism were similar between groups post-intervention. Within the PA plus weight loss group only, serum insulin and HOMA-IR decreased significantly. (4) Conclusions: PA combined with weight loss can decrease total and visceral fat mass and improve insulin sensitivity, confirming that these cancer- and chronic disease-related risk factors are influenced by relatively modest lifestyle changes in the short term.",2020,"At baseline and post-intervention, anthropometrics, body composition, systemic inflammation (high-sensitivity C-reactive protein, tumor necrosis factor-α, and interleukin 6), fasting glucose, insulin and homeostasis model assessment-insulin resistance (HOMA-IR) were determined.","['Older African Americans with Osteoarthritis', 'older, overweight and obese African Americans', 'Subjects had a mean age of 67 years (SD = 5.3) and were mostly women (88', 'older African Americans']","['Physical Activity and Weight Loss', 'PA', 'physical activity (PA) versus PA plus weight loss', 'PA plus weight loss intervention']","['anthropometrics, body composition, systemic inflammation (high-sensitivity C-reactive protein, tumor necrosis factor-α, and interleukin 6), fasting glucose, insulin and homeostasis model assessment-insulin resistance (HOMA-IR', 'inflammation and glucose metabolism', 'total and visceral fat mass and improve insulin sensitivity', 'total and visceral fat', 'serum insulin and HOMA-IR', 'Fat Mass, Glucose Metabolism, and Inflammation']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]",,0.0259348,"At baseline and post-intervention, anthropometrics, body composition, systemic inflammation (high-sensitivity C-reactive protein, tumor necrosis factor-α, and interleukin 6), fasting glucose, insulin and homeostasis model assessment-insulin resistance (HOMA-IR) were determined.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McLeod', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL 60612, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Schiffer', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, USA.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Castellanos', 'Affiliation': 'Department of Medicine, University of Illinois at Chicago, Chicago, IL 60612, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'DeMott', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Olender', 'Affiliation': 'Department of Medicine, University of Illinois at Chicago, Chicago, IL 60612, USA.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Fitzgibbon', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Hughes', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, USA.'}, {'ForeName': 'Giamila', 'Initials': 'G', 'LastName': 'Fantuzzi', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL 60612, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tussing-Humphreys', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL 60612, USA.'}]",Nutrients,['10.3390/nu12113299'] 924,33128725,Validation of the Ankylosing Spondylitis Quality of Life assessment tool in patients with non-radiographic axial spondyloarthritis.,"PURPOSE To evaluate the psychometric performance of the Ankylosing Spondylitis Quality of Life (ASQoL) scale in patients with non-radiographic axial spondyloarthritis (nr-axSpA) to assess its appropriateness as an outcome measure in future clinical studies. METHODS Patients with active axSpA from a Phase III, randomized, double-blind, placebo-controlled trial (RAPID-axSpA, NCT01087762) were included (N = 325). Modified New York (mNY) classification criteria were used to classify patients as having ankylosing spondylitis or nr-axSpA; those with nr-axSpA were further categorized based on objective signs of inflammation. Psychometric properties of the ASQoL were assessed/documented using a mixture of modern psychometric methods and classical test theory methods. These included exploratory factor analysis and item response theory models to assess the domain structure, test the utility of a single domain relative to subdomains, assess bias, and generate statistics to guide an empirical scoring algorithm. The reliability and validity of scores were evaluated via internal consistency, test-retest reliability, concurrent validity, and known-groups validity. Score responsiveness was assessed via anchor-based clinically meaningful change, supplemented with empirical cumulative distribution function visualizations. RESULTS The ASQoL data were defined by four domains. However, a four-domain solution was found to be inferior to a bifactor solution in which the four domains were included within a total domain. Scoring statistics supported a unit-weighted total score. Within the nr-axSpA population with objective signs of inflammation, the ASQoL mean score had adequate reliability, validity, and ability to detect clinically meaningful change. CONCLUSIONS Our findings suggest that the ASQoL is an appropriate outcome measure in interventional clinical trials in patients with nr-axSpA.",2021,"Within the nr-axSpA population with objective signs of inflammation, the ASQoL mean score had adequate reliability, validity, and ability to detect clinically meaningful change. ","['patients with non-radiographic axial spondyloarthritis (nr-axSpA', 'patients with nr-axSpA', 'Patients with active axSpA from a Phase III', 'patients with non-radiographic axial spondyloarthritis']","['Modified New York (mNY', 'placebo', 'ASQoL']","['psychometric performance of the Ankylosing Spondylitis Quality of Life (ASQoL) scale', 'Score responsiveness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3889038', 'cui_str': 'Non-radiographic axial spondyloarthritis'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]","[{'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.181763,"Within the nr-axSpA population with objective signs of inflammation, the ASQoL mean score had adequate reliability, validity, and ability to detect clinically meaningful change. ","[{'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Hoepken', 'Affiliation': 'UCB Pharma, Alfred-Nobel-Strasse 10, 40789, Monheim am Rhein, Germany. Bengt.Hoepken@ucb.com.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Serrano', 'Affiliation': 'Pharmerit International, Bethesda, MD, USA.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Harris', 'Affiliation': 'UCB Pharma, Hong Kong, China.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Hwang', 'Affiliation': 'McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Reveille', 'Affiliation': 'McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-020-02686-0'] 925,33096006,Women and men with coronary heart disease respond similarly to different aerobic exercise training modalities: a pooled analysis of prospective randomized trials.,"We aimed to compare cardiopulmonary exercise test (CPET) parameters, cardiac adaptations, and proportion of responders after different aerobic training programs amongst women and men with coronary heart disease (CHD). Patients with CHD were evaluated with a CPET and echocardiography before and after 3 months of aerobic exercise training. Peak oxygen uptake exercise training response was assessed according to the median peak oxygen uptake change for post- versus pretraining in the whole cohort (stratification non/low responders (NLR) vs. high-responders) and normalized for lean body mass (LBM). Eighty-three CHD patients were included (19 women, 64 men; 27 patients with interval, 19 with continuous, and 37 with combination exercises). Peak oxygen uptake, peak workload normalized for LBM, pulmonary variables (i.e., ventilation and oxygen uptake efficiency slope), and O 2 pulse were significantly lower in women versus men. These parameters improved similarly with training in both sexes ( p < 0.05). There were no differences in the proportion of NLR among women and men with CHD (7/19 (37%) vs. 35/64 (55%), p = 0.1719). Left ventricular ejection fraction and mean peak early diastolic mitral annulus velocity improved similarly with training in both sexes ( p < 0.05). Women and men with CHD have a similar exercise training response regarding key CPET and echocardiographic parameters. The proportion of responders is similar. ClinicalTrials.gov: NCT03414996, NCT02048696, NCT03443193. Novelty: Cardiopulmonary adaptations to exercise training are similar among CHD men and women. Proportion of peak oxygen uptake for non/low/high responders is similar in CHD men and women. Left ventricular systolic and diastolic function improved similarly after exercise training in CHD men and women.",2020,Left ventricular ejection fraction and mean peak early diastolic mitral annulus velocity improved similarly with training in both sexes (p<0.05).,"['CHD men and women', 'Patients with CHD', 'Women and men with coronary heart disease respond similarly to different', 'Women and men with CHD', 'Eighty three CHD patients were included (19 women, 64 men), (27 patients with interval, 19 with continuous and 37 with a combination', 'women and men with coronary heart disease (CHD']","['aerobic exercise training modalities', 'aerobic training programs', 'exercise training', 'cardiopulmonary exercise test (CPET', 'aerobic exercise training']","[""women LV systolic (LVEF) and diastolic (e') function"", 'V̇O2 peak, peak work load normalized for LBM, pulmonary (i.e. ventilation and OUES) and O2 pulse', 'Left ventricular ejection fraction and mean peak early diastolic mitral annulus velocity', 'V̇O2 peak exercise training response', 'proportion of NLRes']","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0225947', 'cui_str': 'Structure of anulus fibrosus of mitral orifice'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]",83.0,0.0452063,Left ventricular ejection fraction and mean peak early diastolic mitral annulus velocity improved similarly with training in both sexes (p<0.05).,"[{'ForeName': 'Lukas-Daniel', 'Initials': 'LD', 'LastName': 'Trachsel', 'Affiliation': 'Cardiovascular Prevention and Rehabilitation (ÉPIC) Center, Montreal Heart Institute, Université de Montréal, Montreal, QC H1T 1N6, Canada.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Boidin', 'Affiliation': 'Cardiovascular Prevention and Rehabilitation (ÉPIC) Center, Montreal Heart Institute, Université de Montréal, Montreal, QC H1T 1N6, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Henri', 'Affiliation': 'Department of Medicine, Faculty of Medicine, Université de Montréal, Montreal, QC H3T 1J4, Canada.'}, {'ForeName': 'Annik', 'Initials': 'A', 'LastName': 'Fortier', 'Affiliation': 'Montreal Health Innovations Coordinating Center, Montreal Heart Institute, Montreal, QC H1T 1C8, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lalongé', 'Affiliation': 'Cardiovascular Prevention and Rehabilitation (ÉPIC) Center, Montreal Heart Institute, Université de Montréal, Montreal, QC H1T 1N6, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Juneau', 'Affiliation': 'Cardiovascular Prevention and Rehabilitation (ÉPIC) Center, Montreal Heart Institute, Université de Montréal, Montreal, QC H1T 1N6, Canada.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Nigam', 'Affiliation': 'Cardiovascular Prevention and Rehabilitation (ÉPIC) Center, Montreal Heart Institute, Université de Montréal, Montreal, QC H1T 1N6, Canada.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Gayda', 'Affiliation': 'Cardiovascular Prevention and Rehabilitation (ÉPIC) Center, Montreal Heart Institute, Université de Montréal, Montreal, QC H1T 1N6, Canada.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2020-0650'] 926,33096333,Effectiveness of guided internet-based interventions in the indicated prevention of depression in green professions (PROD-A): Results of a pragmatic randomized controlled trial.,"BACKGROUND Major Depressive Disorder (MDD) has a major impact on public health. Reduction of depression burden in general population is of greatest importance and might be achieved by implementation of depression prevention measures into routine care. We evaluate an online prevention measure as part of a national project aiming to reduce depression in the occupational group of green professions. METHODS This two-armed pragmatic RCT (n = 360) evaluates the effectiveness of a tailored internet-based intervention (IMI) program compared to enhanced treatment as usual. The IMI program entailed access to one of six guided IMIs each focusing on different symptom areas (depressive mood with optional comorbid diabetes, perceived stress, insomnia, panic and agoraphobia and harmful alcohol consumption). Eligible were entrepreneurs, spouses, family members and pensioners in green professions with adequate insurance status and at least subthreshold depression (PHQ≥5). Primary outcome was depressive symptom severity (QIDS-SR16) at 9-weeks post-treatment (T1). Various secondary outcomes were assessed at T1. RESULTS A small effect of depression reduction (d=-0.28, 95%-CI: -0.50 to -0.07) was found at T1 favouring the IMI program (β=-0.22, 95%-CI: -0.41 to -0.02, p=.033). Categorical analysis indicated a reduced risk of potential MDD with NNTB=28.11. Adherence to the IMI program at T1 was exceptionally low. LIMITATIONS Results are limited to green professions and representativeness might be restricted by self-selection of participants. CONCLUSION Depression burden in green professions can be reduced by this online prevention measure. Yet, short-term effectiveness is restricted by low adherence rates. TRIAL REGISTRATION German Clinical Trial Registration: DRKS00014000. Registered: 09 April 2018.",2021,"A small effect of depression reduction (d=-0.28, 95%-CI: -0.50 to -0.07) was found at T1 favouring the IMI program (β=-0.22, 95%-CI: -0.41 to -0.02, p=.033).","['green professions (PROD-A', 'Eligible were entrepreneurs, spouses, family members and pensioners in green professions with adequate insurance status and at least subthreshold depression (PHQ≥5', 'Major Depressive Disorder (MDD']","['guided internet-based interventions', 'tailored internet-based intervention (IMI) program']","['stress, insomnia, panic and agoraphobia and harmful alcohol consumption', 'risk of potential MDD', 'depressive symptom severity (QIDS-SR16', 'depression reduction']","[{'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0070319', 'cui_str': 'Cytochrome p450 CYP2B1 enzyme'}, {'cui': 'C0162409', 'cui_str': 'Spouse'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0376629', 'cui_str': 'Insurance Status'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.107642,"A small effect of depression reduction (d=-0.28, 95%-CI: -0.50 to -0.07) was found at T1 favouring the IMI program (β=-0.22, 95%-CI: -0.41 to -0.02, p=.033).","[{'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Braun', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, University of Ulm, Ulm, Germany. Electronic address: lina.braun@uni-ulm.de.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Titzler', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Friedrich-Alexander-University of Erlangen-Nürnberg, Erlangen, Germany; GET.ON Institute, Berlin, Germany.'}, {'ForeName': 'Yannik', 'Initials': 'Y', 'LastName': 'Terhorst', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, University of Ulm, Ulm, Germany; Department of Research Methods, Institute of Psychology and Education, University of Ulm, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Freund', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Friedrich-Alexander-University of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Janika', 'Initials': 'J', 'LastName': 'Thielecke', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Friedrich-Alexander-University of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'David Daniel', 'Initials': 'DD', 'LastName': 'Ebert', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Friedrich-Alexander-University of Erlangen-Nürnberg, Erlangen, Germany; GET.ON Institute, Berlin, Germany; Department of Clinical, Neuro- & Developmental Psychology, VU University Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Baumeister', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, University of Ulm, Ulm, Germany.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.066'] 927,33097941,Quantitative and semi-quantitative assessment of synovitis on MRI and the relationship with symptoms in symptomatic knee osteoarthritis.,"OBJECTIVES Synovitis in symptomatic knee OA (KOA) is common and is associated with joint symptoms. Optimal synovial measurement on MRI is, however, unclear. Our aims were to examine the relationship between MRI measures of synovitis and knee symptoms in symptomatic KOA. METHODS Data from a randomized, multicentre, placebo-controlled trial (UK-VIDEO) of vitamin-D therapy in symptomatic KOA were utilized. Participants reported knee symptoms using WOMAC at baseline and annually. On contrast-enhanced (CE) MRI, synovial thickness was measured using established, semi-quantitative methods whilst synovial tissue volume (STV) was assessed as absolute STV (aSTV) and relative to the width of femoral condyle (rSTV). STV of the infrapatellar region was also assessed. Associations between synovial measures and symptoms were analysed using multiple linear regression modelling. RESULTS No linear association was observed between knee symptoms and synovitis thickness scores. Whole-joint aSTV (0.88, 95% CI: 0.17, 1.59) and infrapatellar aSTV (5.96, 95% CI: 1.22, 10.7) were positively associated with knee pain. Whole-joint rSTV had a stronger association with pain (7.96, 95% CI: 2.60, 13.33) and total scores (5.63, 95% CI: 0.32, 10.94). Even stronger associations were found for infrapatellar rSTV with pain (55.47, 95% CI: 19.99, 90.96), function (38.59, 95% CI: 2.1, 75.07) and total scores (41.64, 95% CI: 6.56, 76.72). CONCLUSIONS Whole-joint and site-specific infrapatellar STV measures on CE-MRI were associated with knee pain, respectively. Volumes relative to the size of the femoral condyle may be promising outcome measures in KOA trials.",2021,"Whole-joint and site-specific infrapatellar STV measures on CE-MRI were associated with knee pain, respectively.","['symptomatic knee osteoarthritis', 'symptomatic knee OA (KOA']","['vitamin-D therapy', 'placebo']","['contrast-enhanced (CE) MRI, synovial thickness', 'infrapatellar aSTV', 'infrapatellar rSTV with pain', 'total scores', 'knee symptoms using WOMAC', 'knee pain', 'knee symptoms and synovitis thickness scores', 'absolute STV (aSTV) and relative to the width of femoral condyle (rSTV', 'pain']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0164662', 'cui_str': 'Stavudine'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0039103', 'cui_str': 'Synovitis'}, {'cui': 'C0039099', 'cui_str': 'Synovial membrane'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0582800', 'cui_str': 'Condyle of femur'}]",,0.175211,"Whole-joint and site-specific infrapatellar STV measures on CE-MRI were associated with knee pain, respectively.","[{'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Perry', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, Oxford, UK.'}, {'ForeName': 'Xiaotian', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, Oxford, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'van Santen', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, Oxford, UK.'}, {'ForeName': 'Nigel K', 'Initials': 'NK', 'LastName': 'Arden', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, Oxford, UK.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kluzek', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, Oxford, UK.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa619'] 928,33101194,Hormone Replacement Versus Natural Cycle Protocols of Endometrial Preparation for Frozen Embryo Transfer.,"Research question Endometrial preparation is one of the most important steps for ensuring frozen embryo transfer success. However, there is no clear evidence that identifies an optimal endometrial preparation protocol for frozen embryo transfer. In addition, in studies that assessed which were the optimal endometrial preparation protocols, few analyzed the stage and the number of embryos. This study compared the pregnancy outcomes and perinatal obstetric complications of patients who were transferred two cleavage-stage (day 2 or day 3) frozen embryos with the natural cycle and those with the hormone replacement therapy cycle. Design This study was a secondary analysis of data from a multicentre randomized controlled trial designed to compare the pregnancy and perinatal outcomes after frozen versus fresh embryo transfer. In this study, a total of 908 patients who were transferred two cleavage-stage (day 2 or day 3) embryos in the original trial were analyzed. Pregnancy outcomes and perinatal obstetric complications after the natural cycle and the hormone replacement therapy cycle were compared. Result We found the endometrium in the natural group was significantly thicker than the hormone replacement therapy cycle group ( p <0.01). The implantation rate (42.6% vs 37.3% p =0.049) showed a significant difference between the natural cycle group and the hormone replacement therapy cycle group. Compared to the natural cycle group, the hormone replacement therapy cycle group was associated with an increased risk of caesarean section (72.3% vs 84.5, p =0.009). Conclusion The natural cycle protocol yielded thicker endometria, a higher implantation rate and a lower risk of caesarean section than the hormone replacement therapy protocol in the transfer of two cleavage-stage frozen embryos. The natural cycle protocol was the better endometrial preparation protocol for frozen embryo transfer.",2020,"Compared to the natural cycle group, the hormone replacement therapy cycle group was associated with an increased risk of caesarean section (72.3% vs 84.5, p =0.009). ","['908 patients who were transferred two cleavage-stage (day\xa02\xa0or\xa0day\xa03) embryos in the original trial were analyzed', 'patients who were transferred two cleavage-stage (day\xa02\xa0or\xa0day\xa03) frozen embryos with the natural cycle and those with the hormone replacement therapy cycle']","['frozen versus fresh embryo transfer', 'Hormone Replacement']","['pregnancy outcomes and perinatal obstetric complications', 'risk of caesarean section', 'implantation rate', 'implantation rate and a lower risk of caesarean section', 'Pregnancy outcomes and perinatal obstetric complications']","[{'cui': 'C1321660', 'cui_str': 'Fosamprenavir calcium'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0010813', 'cui_str': 'Cytokinesis'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0440733', 'cui_str': 'Frozen embryo'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy'}]","[{'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0440732', 'cui_str': 'Fresh embryo'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy'}]","[{'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0178292', 'cui_str': 'Complication of pregnancy, childbirth and/or the puerperium'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}]",908.0,0.088604,"Compared to the natural cycle group, the hormone replacement therapy cycle group was associated with an increased risk of caesarean section (72.3% vs 84.5, p =0.009). ","[{'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Ze', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Xiaoshu', 'Initials': 'X', 'LastName': 'Gong', 'Affiliation': 'Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Wenqing', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Yuhua', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University, Jinan, China.'}]",Frontiers in endocrinology,['10.3389/fendo.2020.546532'] 929,33099648,Intravenous immunoglobulins as first-line treatment in idiopathic inflammatory myopathies: a pilot study.,"OBJECTIVES We explored efficacy and safety of IVIg as first-line treatment in patients with an idiopathic inflammatory myopathy. METHODS In this investigator-initiated phase 2 open-label study, we included 20 adults with a newly diagnosed, biopsy-proven idiopathic inflammatory myopathy, and a disease duration of less than 9 months. Patients with IBM and prior use of immunosuppressants were excluded. The standard treatment regimen consisted of IVIg (Privigen) monotherapy for 9 weeks: a loading dose (2 g/kg body weight) and two subsequent maintenance doses (1 g/kg body weight) with a 3-week interval. The primary outcome was the number of patients with at least moderate improvement on the 2016 ACR/EULAR Total Improvement Score. Secondary outcomes included time to improvement, the number of patients requiring rescue medication and serious adverse events. RESULTS We included patients with DM (n = 9), immune-mediated necrotizing myopathy (n = 6), non-specific myositis/overlap myositis (n = 4) and anti-synthetase syndrome (n = 1). One patient was excluded from analyses because of minimal weakness resulting in a ceiling effect. Eight patients (8/19 = 42.0%; Clopper-Pearson 95% CI: 19.6, 64.6) had at least moderate improvement by 9 weeks. Of these, six reached improvement by 3 weeks. Seven patients required rescue medication due to insufficient efficacy and prematurely ended the study. Three serious adverse events occurred, of which one was pulmonary embolism. CONCLUSION First-line IVIg monotherapy led to at least moderate improvement in nearly half of patients with a fast clinical response in the majority of responders. TRIAL REGISTRATION Netherlands Trial Register identifier, NTR6160.",2021,"Three serious adverse events occurred, of which one was pulmonary embolism. ","['patients with DM (n\u2009=\u20099), immune-mediated necrotizing myopathy (n\u2009=\u20096), non-specific myositis/overlap myositis (n\u2009=\u20094) and anti-synthetase syndrome (n\u2009=\u20091', '9\u2009weeks', '20 adults with a newly diagnosed, biopsy-proven idiopathic inflammatory myopathy, and a disease duration of less than 9\u2009months', 'Patients with IBM and prior use of immunosuppressants were excluded', 'idiopathic inflammatory myopathies', 'patients with an idiopathic inflammatory myopathy']","['IVIg (Privigen', 'monotherapy', 'Intravenous immunoglobulins']","['time to improvement, the number of patients requiring rescue medication and serious adverse events', 'number of patients with at least moderate improvement on the 2016 ACR/EULAR Total Improvement Score', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0026848', 'cui_str': 'Disorder of muscle'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0027121', 'cui_str': 'Myositis'}, {'cui': 'C0185027', 'cui_str': 'Imbrication'}, {'cui': 'C0023689', 'cui_str': 'Ligase'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0751356', 'cui_str': 'Idiopathic inflammatory myopathy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0238190', 'cui_str': 'Inclusion body myositis'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C2342400', 'cui_str': 'Privigen'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",20.0,0.0560137,"Three serious adverse events occurred, of which one was pulmonary embolism. ","[{'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Lim', 'Affiliation': 'Department of Neurology, Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, The Netherlands.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Eftimov', 'Affiliation': 'Department of Neurology, Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, The Netherlands.'}, {'ForeName': 'Camiel', 'Initials': 'C', 'LastName': 'Verhamme', 'Affiliation': 'Department of Neurology, Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Brusse', 'Affiliation': 'Department of Neurology, Erasmus UMC, Rotterdam, The Netherlands.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Hoogendijk', 'Affiliation': 'Department of Neurology, Brain Centre Rudolf Magnus, UMC Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Christiaan G J', 'Initials': 'CGJ', 'LastName': 'Saris', 'Affiliation': 'Department of Neurology, Radboud UMC, Donders Institute for Brain Cognition and Behaviour, Nijmegen, The Netherlands.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Raaphorst', 'Affiliation': 'Department of Neurology, Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, The Netherlands.'}, {'ForeName': 'Rob J', 'Initials': 'RJ', 'LastName': 'De Haan', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Ivo N', 'Initials': 'IN', 'LastName': 'van Schaik', 'Affiliation': 'Department of Neurology, Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, The Netherlands.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Aronica', 'Affiliation': 'Department of (Neuro)Pathology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'de Visser', 'Affiliation': 'Department of Neurology, Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, The Netherlands.'}, {'ForeName': 'Anneke J', 'Initials': 'AJ', 'LastName': 'van der Kooi', 'Affiliation': 'Department of Neurology, Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, The Netherlands.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa459'] 930,33106028,Medium-Term Results of Corticosteroid Injections for Morton's Neuroma.,"BACKGROUND The objective of this study was to evaluate the medium-term results of corticosteroid injections for Morton's neuroma. METHODS This was a prospective follow-up study of a previous randomized controlled trial (RCT). Forty-five neuromas in 36 patients were injected with a single corticosteroid injection either with or without ultrasound guidance. As the results of the RCT showed no difference in outcomes between techniques, the data were pooled for the purpose of this study. Questionnaires were sent out and responses were collected via mail or telephone interview. Results were available in 42 out of 45 neuromas. There was a sex split of 68% female/32% male with a mean age of 62.6 years (SD, 12 years). RESULTS At mean follow-up of 4.8 years (SD, 0.91 years), the original corticosteroid injection remained effective in 36% ( n = 16) of the patients. In these cases, the visual analog scale (VAS) pain score ( P < .001) and Manchester-Oxford Foot Questionnaire Index (MOxFQ Index) ( P = .001) remained significantly better than preintervention scores. The remaining cases underwent either a further injection or surgery. Fifty-five percent of the 11 neuromas that received a second injection continued to be asymptomatic in the medium term. Overall, 44% ( n = 20) of the initial cohort underwent surgical excision by the medium-term follow-up. The VAS score, MOxFQ Index, and satisfaction scale score across all groups were not significantly different. CONCLUSION Corticosteroid injections for Morton's neuroma remained effective in over a third of cases for up to almost 5 years. A positive outcome at 1 year following a corticosteroid injection was reasonably predictive of a prolonged effect from the injection. LEVEL OF EVIDENCE Level II, prospective comparative study.",2021,Corticosteroid injections for Morton's neuroma remained effective in over a third of cases for up to almost 5 years.,"[""Morton's Neuroma"", 'Forty-five neuromas in 36 patients', 'sex split of 68% female/32% male with a mean age of 62.6 years (SD, 12 years']","['corticosteroid injection', 'Corticosteroid Injections', 'corticosteroid injection either with or without ultrasound guidance', 'Corticosteroid injections', 'corticosteroid injections']","['Manchester-Oxford Foot Questionnaire Index (MOxFQ Index', 'VAS score, MOxFQ Index, and satisfaction scale score', 'visual analog scale (VAS) pain score']","[{'cui': 'C0311337', 'cui_str': ""Morton's neuroma""}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0027858', 'cui_str': 'Neuroma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}]",36.0,0.0273226,Corticosteroid injections for Morton's neuroma remained effective in over a third of cases for up to almost 5 years.,"[{'ForeName': 'Melinda Yun Ting', 'Initials': 'MYT', 'LastName': 'Hau', 'Affiliation': 'Trauma and Orthopaedic Surgery, University Hospitals of Leicester, Leicester, UK.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Thomson', 'Affiliation': 'Trauma and Orthopaedic Surgery, University Hospitals of Leicester, Leicester, UK.'}, {'ForeName': 'Randeep', 'Initials': 'R', 'LastName': 'Aujla', 'Affiliation': 'Trauma and Orthopaedic Surgery, University Hospitals of Leicester, Leicester, UK.'}, {'ForeName': 'Devendra', 'Initials': 'D', 'LastName': 'Madhadevan', 'Affiliation': 'Trauma and Orthopaedic Surgery, Royal Berkshire Hospital, Reading, UK.'}, {'ForeName': 'Maneesh', 'Initials': 'M', 'LastName': 'Bhatia', 'Affiliation': 'Trauma and Orthopaedic Surgery, University Hospitals of Leicester, Leicester, UK.'}]",Foot & ankle international,['10.1177/1071100720966332'] 931,33107803,Pulmonary Metastasectomy for Colorectal Cancer: Randomized Controlled Trial.,,2021,,['Colorectal Cancer'],[],[],"[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]",[],[],,0.182709,,"[{'ForeName': 'Norman R', 'Initials': 'NR', 'LastName': 'Williams', 'Affiliation': 'Clinical and Interventional Trials Unit and.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Treasure', 'Affiliation': 'Clinical Operational Research Unit, University College London, Gower Street, London WC1E 6BT, England.'}, {'ForeName': 'Fergus', 'Initials': 'F', 'LastName': 'Macbeth', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, Wales.'}]",Radiology,['10.1148/radiol.2020202862'] 932,33104822,Effect of compression fracture on trabecular bone score at lumbar spine.,"Bone mineral density (BMD) may be increased due to vertebral compression fractures (VCF). Our study showed trabecular bone scores (TBS) was less affected than BMD by fractured vertebrae. The TBS of most compression fractures, including old and recent VCF with mild or moderate deformity and old VCF with severe deformity, could still be used in predicting fracture risk. INTRODUCTION Trabecular bone score (TBS), a noninvasive tool estimating bone microarchitecture, provides complementary information to lumbar spine bone mineral density (BMD). Lumbar spine BMD might be increased due to both degenerative disease and vertebral compression fractures (VCF). Lumbar spine TBS has been confirmed not influenced by osteoarthrosis, but the effects of VCF are still not been well evaluated. This study aimed to investigate whether lumbar spine TBS was affected by fractured vertebrae. METHODS We studied postmenopausal women and men above 50 years old who underwent DXA between January 1, 2017, and May 31, 2019. By calculating the difference of BMD and TBS between L1 and the mean of L2-3, the study compared the difference of values between the control group and fracture group to determine the effects of fractured vertebrae on BMD and TBS. RESULTS A total of 377 participants were enrolled with 202 in the control group (157 females; age: 68.06 ± 6.47 years) and 175 in the fracture group (147 females; age: 71.71 ± 9.44 years). The mean BMD of the L1 vertebrae in the fracture group was significantly higher than that in the control group (p < 0.0001). There was no significant difference between the mean differences of TBS between L1 and the means of L2-3 vertebrae in the control group and the most compression fractures, including old and recent VCF with mild or moderate deformity and old VCF with severe deformity. CONCLUSION Lumbar spine TBS, unlike BMD, is less affected by fractured vertebrae. The TBS of most compression fractures, including old and recent VCF with mild or moderate deformity and old VCF with severe deformity, could still be used in predicting fracture risk.",2021,"There was no significant difference between the mean differences of TBS between L1 and the means of L2-3 vertebrae in the control group and the most compression fractures, including old and recent VCF with mild or moderate deformity and old VCF with severe deformity. ","['postmenopausal women and men above 50 years old who underwent DXA between January 1, 2017, and May 31, 2019', 'lumbar spine', '377 participants were enrolled with 202 in the control group (157 females; age: 68.06\xa0±\xa06.47 years) and 175 in the fracture group (147 females; age: 71.71\xa0±\xa09.44 years']",['compression fracture'],"['BMD and TBS', 'Bone mineral density (BMD', 'lumbar spine TBS', 'mean BMD of the L1 vertebrae', 'lumbar spine bone mineral density (BMD', 'trabecular bone score', 'trabecular bone scores (TBS', 'Trabecular bone score (TBS']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0262431', 'cui_str': 'Compression fracture of vertebral column'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0222660', 'cui_str': 'Trabecular substance of bone'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}]",377.0,0.0242367,"There was no significant difference between the mean differences of TBS between L1 and the means of L2-3 vertebrae in the control group and the most compression fractures, including old and recent VCF with mild or moderate deformity and old VCF with severe deformity. ","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Hsu', 'Affiliation': 'Department of Medical Imaging, Chi Mei Medical Center, No. 901, Zhonghua Rd., Yongkang Dist., Tainan City, 710, Taiwan.'}, {'ForeName': 'T-J', 'Initials': 'TJ', 'LastName': 'Hsieh', 'Affiliation': 'Department of Medical Imaging, Chi Mei Medical Center, No. 901, Zhonghua Rd., Yongkang Dist., Tainan City, 710, Taiwan. tsyhjyi.hsieh@gmail.com.'}, {'ForeName': 'C-H', 'Initials': 'CH', 'LastName': 'Ho', 'Affiliation': 'Department of Medical Research, Chi Mei Medical Center, Yongkang, Tainan, Taiwan.'}, {'ForeName': 'C-H', 'Initials': 'CH', 'LastName': 'Lin', 'Affiliation': 'Department of Medical Imaging, Chi Mei Medical Center, No. 901, Zhonghua Rd., Yongkang Dist., Tainan City, 710, Taiwan.'}, {'ForeName': 'C K-H', 'Initials': 'CK', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Imaging, Chi Mei Medical Center, No. 901, Zhonghua Rd., Yongkang Dist., Tainan City, 710, Taiwan.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-020-05707-3'] 933,33111988,"Repeated delivery of chlorhexidine chips for the treatment of peri-implantitis: A multicenter, randomized, comparative clinical trial.","BACKGROUND Peri-implantitis is a challenging condition to manage and is frequently treated using non-surgical debridement. The local delivery of antimicrobial agents has demonstrated benefit in mild to moderate cases of peri-implantitis. This study compared the safety and efficacy of chlorhexidine gluconate 2.5 mg chip (CHX chips) as an adjunctive treatment to subgingival debridement in patients afflicted with peri-implantitis. METHODS A multicenter, randomized, single-blind, two-arm, parallel Phase-3 study was conducted. Peri-implantitis patients with implant pocket depths (IPD) of 5-8 mm underwent subgingival implant surface debridement followed by repeated bi-weekly supragingival plaque removal and chlorhexidine chips application (ChxC group) for 12 weeks, or similar therapy but without application of ChxC (control group). All patients were followed for 24 weeks. Plaque and gingival indices were measured at every visit whereas IPD, recession, and bleeding on probing were assessed at 8, 12, 16, 24 week. RESULTS A total of 290 patients were included: 146 in the ChxC group and 144 in the control. At 24 weeks, a significant reduction in IPD (P = 0.01) was measured in the ChxC group (1.76 ± 1.13 mm) compared with the control group (1.54 ± 1.13 mm). IPD reduction of ≥2 mm was found in 59% and 47.2% of the implants in the ChxC and control groups, respectively (P = 0.03). Changes in gingival recession (0.29 ± 0.68 mm versus 0.15 ± 0.55 mm, P = 0.015) and relative attachment gain (1.47 ± 1.32 mm and 1.39 ± 1.27 mm, P = 0.0017) were significantly larger in the ChxC group. Patients in the ChxC group that were < 65 years exhibited significantly better responses (P < 0.02); likewise, non-smokers had similarly better response (P < 0.02). Both protocols were well tolerated, and no severe treatment-related adverse events were recorded throughout the study. CONCLUSIONS Patients with peri-implantitis that were treated with an intensive treatment protocol of bi-weekly supragingival plaque removal and local application of chlorhexidine chips had greater mean IPD reduction and greater percentile of sites with IPD reduction of ≥2 mm as compared with bi-weekly supra-gingival plaque removal.",2021,"IPD reduction of ≥2 mm was found in 59% and 47.2% of the implants in the ChxC and control groups, respectively (p = 0.03).","['290 patients were included: 146 in the ChxC group and 144 in the control', 'periimplantitis', 'patients afflicted with periimplantitis', 'Periimplantitis patients with implant pocket depths (IPD) of 5-8 mm underwent', 'Patients with periimplantitis']","['chlorhexidine chips', 'Chlorhexidine gluconate 2.5 mg chip (CHX chips', 'sub-gingival implant surface debridement followed by repeated bi-weekly supra-gingival plaque removal and Chlorhexidine chips application (ChxC group) for 12 weeks, or similar therapy but without application of ChxC (control group', 'Chlorhexidine chips']","['IPD reduction of ≥2 mm', 'mean IPD reduction', 'tolerated, and no severe treatment-related adverse events', 'safety and efficacy', 'Plaque and gingival indices', 'Changes in gingival recession', 'relative attachment gain', 'IPD']","[{'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2936258', 'cui_str': 'Dental peri-implantitis'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0057856', 'cui_str': 'iproplatin'}, {'cui': 'C2608961', 'cui_str': 'chlorhexidine gluconate 2.5 MG'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]",290.0,0.0614733,"IPD reduction of ≥2 mm was found in 59% and 47.2% of the implants in the ChxC and control groups, respectively (p = 0.03).","[{'ForeName': 'Eli E', 'Initials': 'EE', 'LastName': 'Machtei', 'Affiliation': 'Department of Periodontology, School of Graduate Dentistry, Faculty of Medicine, Technion (I.I.T.), Rambam health care campus, Haifa, Israel.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Romanos', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, Stony Brook, New York, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Kang', 'Affiliation': 'Division of Periodontics, Section of Oral, Diagnostic and Rehabilitation Sciences, College of Dental Medicine, Columbia University, New York, USA.'}, {'ForeName': 'Suncica', 'Initials': 'S', 'LastName': 'Travan', 'Affiliation': 'Department of Periodontics and Oral Medicine, University of Michigan School of Dentistry, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': 'Department of Periodontics, Justus-Liebig University, Giessen & Avadent, Bad Homburg, Germany.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Papathanasiou', 'Affiliation': 'Department of Periodontology, Tufts University School of Dental Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Tatarakis', 'Affiliation': 'Center for Oral Clinical Research, Barts & The Royal London School of Medicine and Dentistry, Institute of Dentistry, Queen Mary University of London (QMUL), London, UK.'}, {'ForeName': 'Moshik', 'Initials': 'M', 'LastName': 'Tandlich', 'Affiliation': 'Department of Periodontology, the Hebrew University-Hadassah Faculty of Dental Medicine, Jerusalem, Israel.'}, {'ForeName': 'Leila H', 'Initials': 'LH', 'LastName': 'Liberman', 'Affiliation': 'Central Texas Veterans Health Care System, Texas, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Horwitz', 'Affiliation': 'Department of Periodontology, School of Graduate Dentistry, Faculty of Medicine, Technion (I.I.T.), Rambam health care campus, Haifa, Israel.'}, {'ForeName': 'Seyed Hossein', 'Initials': 'SH', 'LastName': 'Bassir', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, Stony Brook, New York, USA.'}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Myneni', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, Stony Brook, New York, USA.'}, {'ForeName': 'Harlan J', 'Initials': 'HJ', 'LastName': 'Shiau', 'Affiliation': 'Department of Advanced Oral Sciences and Therapeutics, School of Dentistry, University of Maryland, Maryland, USA.'}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Shapira', 'Affiliation': 'Department of Periodontology, the Hebrew University-Hadassah Faculty of Dental Medicine, Jerusalem, Israel.'}, {'ForeName': 'Nikos', 'Initials': 'N', 'LastName': 'Donos', 'Affiliation': 'Center for Oral Clinical Research, Barts & The Royal London School of Medicine and Dentistry, Institute of Dentistry, Queen Mary University of London (QMUL), London, UK.'}, {'ForeName': 'Athena', 'Initials': 'A', 'LastName': 'Papas', 'Affiliation': 'Division of Oral Medicine, Tufts University School of Dental Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Meyle', 'Affiliation': 'Department of Periodontics, Justus-Liebig University, Giessen & Avadent, Bad Homburg, Germany.'}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'Giannobile', 'Affiliation': 'Division of Periodontology, Department of Oral Medicine Infection and Immunity, Harvard School of Dental Medicine, Harvard University, Boston, Massachusetts, USA.'}, {'ForeName': 'Panos N', 'Initials': 'PN', 'LastName': 'Papapanou', 'Affiliation': 'Division of Periodontics, Section of Oral, Diagnostic and Rehabilitation Sciences, College of Dental Medicine, Columbia University, New York, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Kim', 'Affiliation': 'Division of Periodontology, Department of Oral Medicine Infection and Immunity, Harvard School of Dental Medicine, Harvard University, Boston, Massachusetts, USA.'}]",Journal of periodontology,['10.1002/JPER.20-0353'] 934,33118432,Drug-Coated Balloon Angioplasty Compared With Uncoated Balloons in the Treatment of Infrapopliteal Artery Lesions (AcoArt II-BTK).,"PURPOSE To compare the safety and efficacy of drug-coated balloon (DCB) vs uncoated balloon angioplasty in the treatment of de novo and restenotic infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI). MATERIALS AND METHODS The prospective, multicenter, randomized study AcoArt II-BTK study ( ClinicalTrials.gov identifier NCT02137577) enrolled 120 patients who were randomly assigned to angioplasty with either a DCB (n=61; mean age 70.7±7.4 years; 36 men) or a conventional balloon catheter (n=59; mean age 70.8±9.0 years; 36 men). There were no significant differences observed in baseline clinical or target lesion characteristics between the groups. The target lesion length was 169.95±86.35 mm in the DCB group vs 179.93±80.16 mm in the control group, and approximately three-quarters of the lesions were chronic occlusions. Primary patency was assessed by angiography at 6 months, and mortality and clinically-driven target lesion revascularization (CD-TLR) were evaluated at 12 months. RESULTS Primary patency at 6 months was 75.0% in the DCB group and 28.3% in the control group (p<0.001), while late lumen loss was 0.43±0.62 mm for DCBs vs 0.99±0.55 mm for controls (p<0.001). Freedom from CD-TLR at 12 months was 91.5% in the DCB group vs 76.8% in the controls (p=0.03); there was no significant difference in mortality (1.7% DCB vs 3.6% controls; p=0.53). CONCLUSION This study demonstrated that the Litos/Tulip DCBs are safe and effective in treating infrapopliteal lesions, with improved angiographic and clinical outcomes vs plain balloon angioplasty. The DCBs demonstrated significantly higher primary patency with fewer CD-TLRs than conventional angioplasty. The safety of the DCBs was noninferior to that of the uncoated balloons after 1 year of follow-up.",2021,The safety of the DCBs was noninferior to that of the uncoated balloons after 1 year of follow-up.,"['n=59; mean age 70.8±9.0 years; 36 men', '120 patients who were randomly assigned to angioplasty with either a DCB (n=61; mean age 70.7±7.4 years; 36 men) or a', 'patients with chronic limb-threatening ischemia (CLTI']","['Drug-Coated Balloon Angioplasty', 'Litos/Tulip DCBs', 'drug-coated balloon (DCB) vs uncoated balloon angioplasty', 'Uncoated Balloons', 'DCB', 'conventional balloon catheter', 'plain balloon angioplasty']","['baseline clinical or target lesion characteristics', 'safety and efficacy', 'target lesion length', 'late lumen loss', 'mortality and clinically-driven target lesion revascularization (CD-TLR', 'mortality']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0002996', 'cui_str': 'Balloon Angioplasty'}, {'cui': 'C0331680', 'cui_str': 'Tulipa'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0441127', 'cui_str': 'Balloon dilatation catheter'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",120.0,0.0762924,The safety of the DCBs was noninferior to that of the uncoated balloons after 1 year of follow-up.,"[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Jia', 'Affiliation': 'Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Baixi', 'Initials': 'B', 'LastName': 'Zhuang', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'The First Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Yongquan', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jiwei', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xinwu', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': ""The Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Xiangchen', 'Initials': 'X', 'LastName': 'Dai', 'Affiliation': 'Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Zhaoyu', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Shengjing Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Bi', 'Affiliation': 'The Second Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Changwei', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Shenming', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Liistro', 'Affiliation': 'Cardiovascular Department, San Donato Hospital, Arezzo, Italy.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': 'Chinese PLA General Hospital, Beijing, China.'}]",Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists,['10.1177/1526602820969681'] 935,33118433,Satisfactory Long-term Outcomes of Thoracic Endovascular Aortic Repair With a Bare Stent for Acute Complicated Type B Aortic Dissections.,"PURPOSE To compare the clinical outcomes after thoracic endovascular aortic repair (TEVAR) with a bare stent to those after TEVAR alone in patients with complicated acute type B aortic dissection (cATBAD). MATERIALS AND METHODS A prospective, randomized trial was conducted at 2 medical centers in China between 2010 and 2013. Patients with cATBAD were randomly assigned to receive TEVAR with a bare stent (n=42) or TEVAR only (n=42). Patients were scheduled to undergo computed tomography angiography at 3, 6, and 12 months and then annually to 5 years. The primary endpoint was all-cause mortality at 5 years; secondary outcomes were a composite of complications (endoleak, stent-graft-induced new entry, aortic rupture, and secondary intervention) and aortic remodeling at 1 and 5 years. RESULTS All-cause death occurred in 1 (2.4%) patient in the TEVAR with bare stent group (lung cancer) and 5 patients (11.9%) in the TEVAR group (4 aorta-related) during the 5-year follow-up (log-rank p=0.025). The 1- and 5-year rates of complications and secondary interventions did not differ between the groups. Patients in the TEVAR with bare stent group had higher increases in the thoracic true lumen diameter (19.7±3.6 vs 17.0±6.2 mm, p=0.018) and abdominal true lumen diameter (13.7±4.8 vs 7.2±6.1 mm, p<0.001) and a higher incidence of complete false lumen thrombosis (80.9% vs 47.6%, p=0.005) at the 1-year follow-up. However, no between-group differences in the changes of aortic remodeling parameters were observed between the 1- and 5-year follow-up periods. CONCLUSION The addition of a distal bare stent to a thoracic stent-graft during TEVAR was associated with significantly improved long-term survival in cATBAD patients vs TEVAR only, likely due to the prevention of true lumen collapse and improvement of complete false lumen thrombosis of the dissected aorta.",2021,The 1- and 5-year rates of complications and secondary interventions did not differ between the groups.,"['2 medical centers in China between 2010 and 2013', 'patients with complicated acute type B aortic dissection (cATBAD', 'Patients with cATBAD', 'Acute Complicated Type B Aortic Dissections']","['Thoracic Endovascular Aortic Repair With a Bare Stent', 'TEVAR alone', 'thoracic endovascular aortic repair (TEVAR', 'TEVAR', 'TEVAR with a bare stent (n=42) or TEVAR', 'computed tomography angiography']","['long-term survival', 'cause mortality', 'aortic remodeling parameters', 'All-cause death', 'composite of complications (endoleak, stent-graft-induced new entry, aortic rupture, and secondary intervention) and aortic remodeling at 1 and 5 years', 'complete false lumen thrombosis', '1- and 5-year rates of complications and secondary interventions', 'thoracic true lumen diameter', 'abdominal true lumen diameter']","[{'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0340647', 'cui_str': 'Dissection of distal aorta'}]","[{'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1504464', 'cui_str': 'Endoleak'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0003496', 'cui_str': 'Aortic rupture'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205237', 'cui_str': 'False'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0205238', 'cui_str': 'True'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}]",,0.0747711,The 1- and 5-year rates of complications and secondary interventions did not differ between the groups.,"[{'ForeName': 'Yaowang', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': ""Department of Cardiology, Shenzhen People's Hospital, 2nd Clinical Medical College of Jinan University, First Affiliated Hospital of South University of Science and Technology, Shenzhen, Guangdong, People's Republic of China.""}, {'ForeName': 'Shaohong', 'Initials': 'S', 'LastName': 'Dong', 'Affiliation': ""Department of Cardiology, Shenzhen People's Hospital, 2nd Clinical Medical College of Jinan University, First Affiliated Hospital of South University of Science and Technology, Shenzhen, Guangdong, People's Republic of China.""}, {'ForeName': 'Jianfan', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': ""Department of Cardiology, Guangdong General Hospital, Guangdong Academy of Sciences, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Weijie', 'Initials': 'W', 'LastName': 'Bei', 'Affiliation': ""Department of Cardiology, Shenzhen People's Hospital, 2nd Clinical Medical College of Jinan University, First Affiliated Hospital of South University of Science and Technology, Shenzhen, Guangdong, People's Republic of China.""}, {'ForeName': 'Qiyun', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, Shenzhen People's Hospital, 2nd Clinical Medical College of Jinan University, First Affiliated Hospital of South University of Science and Technology, Shenzhen, Guangdong, People's Republic of China.""}, {'ForeName': 'Xinli', 'Initials': 'X', 'LastName': 'Pang', 'Affiliation': ""Department of Cardiology, Shenzhen People's Hospital, 2nd Clinical Medical College of Jinan University, First Affiliated Hospital of South University of Science and Technology, Shenzhen, Guangdong, People's Republic of China.""}, {'ForeName': 'Huadong', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, Shenzhen People's Hospital, 2nd Clinical Medical College of Jinan University, First Affiliated Hospital of South University of Science and Technology, Shenzhen, Guangdong, People's Republic of China.""}]",Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists,['10.1177/1526602820966991'] 936,33118456,Parent Ethical Concerns About Patient Feedback Measures to Improve Pediatric Clinical Care.,"There are limited studies evaluating parental willingness to complete patient feedback measures to improve pediatric clinical care. Parents were randomly assigned to read a vignette that varied by parent satisfaction and type of feedback measure. Parents were generally willing to participate in the hypothetical research study aimed to improve their child's clinical care. Parents in the dissatisfied condition invited to participate in a potentially identifiable interview, compared to an anonymous survey, reported they would be less likely to respond honestly and more likely to feel obligated to participate. Researchers aiming to improve pediatric clinical care should be encouraged to use patient feedback measures that collect potentially identifiable information; however, researchers must consider the potential impact of parent satisfaction on feedback.",2021,"Parents in the dissatisfied condition invited to participate in a potentially identifiable interview, compared to an anonymous survey, reported they would be less likely to respond honestly and more likely to feel obligated to participate.",[],[],[],[],[],[],,0.0178364,"Parents in the dissatisfied condition invited to participate in a potentially identifiable interview, compared to an anonymous survey, reported they would be less likely to respond honestly and more likely to feel obligated to participate.","[{'ForeName': 'Paulina S', 'Initials': 'PS', 'LastName': 'Lim', 'Affiliation': '14751University of Wisconsin-Milwaukee, Milwaukee, WI, USA.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Lang', 'Affiliation': '14751University of Wisconsin-Milwaukee, Milwaukee, WI, USA.'}, {'ForeName': 'W Hobart', 'Initials': 'WH', 'LastName': 'Davies', 'Affiliation': '14751University of Wisconsin-Milwaukee, Milwaukee, WI, USA.'}]",Journal of empirical research on human research ethics : JERHRE,['10.1177/1556264620969327'] 937,33113007,Addition of dexamethasone to manage acute phase responses following initial zoledronic acid infusion.,"Acute phase response (APR), including myalgia, influenza-like symptoms, headache, arthralgia, and pyrexia, is the most common adverse reaction to initial zoledronic acid infusion. Dexamethasone plus acetaminophen is effective in significantly reducing the incidence and severity of APR. INTRODUCTION Acute phase response (APR), including myalgia, influenza-like symptoms, headache, arthralgia, and pyrexia, is due to immunomodulatory actions and is the most common adverse reaction to zoledronic acid (ZOL). The aims of our study were to compare the differences between acetaminophen and dexamethasone plus acetaminophen on the incidence and severity of APRs and to clarify the clinical factors related to APR with initial ZOL infusion. METHODS Patients with osteoporosis receiving their first ZOL infusion (N = 96) were assigned into two groups and given either acetaminophen (58 patients, control group) or acetaminophen plus dexamethasone (38 patients, study group). APRs were assessed through telephone interviews 2 weeks later post-infusion. Clinical, demographic, and serologic data were recorded. RESULTS There was a significant increase in the incidence and severity of any APR in the control group than the study group (67% vs. 34%, p = 0.003; 0.69 ± 0.50 vs. 0.34 ± 0.48, p = 0.001). Among the APRs, only myalgia incidence and score were significantly higher in the control group than in the study group. Multivariate analysis demonstrated that previous use of osteoporosis medication and participation in the study group was negatively related to the occurrence of any APR or myalgia. Advanced age was shown to significantly increase myalgia. Study group participants had significantly reduced severity of myalgia. The adherence for redosing ZOL was significantly higher in the study group. CONCLUSION Dexamethasone plus acetaminophen is effective in significantly reducing the incidence and severity of APR, especially myalgia, and increasing adherence following initial ZOL infusion.",2021,"Among the APRs, only myalgia incidence and score were significantly higher in the control group than in the study group.",['Patients with osteoporosis receiving their first ZOL infusion (N = 96'],"['acetaminophen', 'zoledronic acid (ZOL', 'Dexamethasone plus acetaminophen', 'dexamethasone', 'zoledronic acid infusion', 'acetaminophen and dexamethasone plus acetaminophen', 'acetaminophen plus dexamethasone']","['Acute phase response (APR), including myalgia, influenza-like symptoms, headache, arthralgia, and pyrexia', 'incidence and severity of any APR', 'incidence and severity of APR, especially myalgia', 'adherence for redosing ZOL', 'severity of myalgia', 'myalgia', 'occurrence of any APR or myalgia', 'myalgia incidence and score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0001349', 'cui_str': 'Acute phase reaction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0392171', 'cui_str': 'Influenza-like symptoms'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",96.0,0.0339458,"Among the APRs, only myalgia incidence and score were significantly higher in the control group than in the study group.","[{'ForeName': 'F-P', 'Initials': 'FP', 'LastName': 'Chen', 'Affiliation': 'Keelung Osteoporosis Prevention and Treatment Center, Chang Gung Memorial Hospital, Keelung, 204, Taiwan. fangping@cgmh.org.tw.'}, {'ForeName': 'T-S', 'Initials': 'TS', 'LastName': 'Fu', 'Affiliation': 'Keelung Osteoporosis Prevention and Treatment Center, Chang Gung Memorial Hospital, Keelung, 204, Taiwan.'}, {'ForeName': 'Y-C', 'Initials': 'YC', 'LastName': 'Lin', 'Affiliation': 'Keelung Osteoporosis Prevention and Treatment Center, Chang Gung Memorial Hospital, Keelung, 204, Taiwan.'}, {'ForeName': 'Y-J', 'Initials': 'YJ', 'LastName': 'Lin', 'Affiliation': 'Research Service Center for Health Information, Chang Gung University, Tao-Yuan, 259, Taiwan.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-020-05653-0'] 938,33114566,Visual Function and Macular Carotenoid Changes in Eyes with Retinal Drusen-An Open Label Randomized Controlled Trial to Compare a Micronized Lipid-Based Carotenoid Liquid Supplementation and AREDS-2 Formula.,"PURPOSE To compare the changes in visual and ocular parameters in individuals with retinal drusen who were treated with two commercially available nutritional supplements. METHODS An open-label, single-center, randomized, parallel-treatment with an observational control group design was utilized. The treatment groups included individuals with fine retinal drusen sub-clinical age-related macular degeneration (AMD), while the control group consisted of ocular normal individuals. The treatment groups were randomly assigned to the micronized lipid-based carotenoid supplement, Lumega-Z (LM), or the PreserVision Age-Related Eye Disease Study 2 (AREDS-2) soft gel (PV). Visual performance was evaluated using the techniques of visual acuity, dark adaptation recovery and contrast sensitivity, at baseline, three months, and six months. Additionally, the macular pigment optical density (MPOD) was measured. The control group was not assigned any carotenoid supplement. The right eye and left eye results were analyzed separately. RESULTS Seventy-nine participants were recruited for this study, of which 68 qualified and 56 participants had useable reliable data. Of the individuals who completed this study, 25 participants belonged to the LM group, 16 belonged to the PV group, and 15 to the control group. The LM group demonstrated statistically significant improvements in contrast sensitivity function (CSF) in both eyes at six months ( p < 0.001). The LM group displayed a positive linear trend with treatment time in CSF ( p < 0.001), with benefits visible after just three months of supplementation. Although there was a trend showing improvement in CSF in the PV group, the change was not significant after a Bonferroni-corrected p -value of p < 0.00625. Visual acuity, dark adaptation recovery and MPOD did not significantly improve in either treatment groups. CONCLUSION The LM group demonstrated greater and faster benefits in visual performance as measured by CSF when compared to the PV group. This trial has been registered at clinicaltrials.gov (NCT03946085).",2020,The LM group demonstrated statistically significant improvements in contrast sensitivity function (CSF) in both eyes at six months ( p < 0.001).,"['individuals with fine retinal drusen sub-clinical age-related macular degeneration (AMD), while the control group consisted of ocular normal individuals', '25 participants belonged to the LM group, 16 belonged to the PV group, and 15 to the control group', 'Seventy-nine participants were recruited for this study, of which 68 qualified and 56 participants had useable reliable data', 'individuals with retinal drusen who were treated with two commercially available nutritional supplements', 'Eyes with Retinal Drusen']","['Micronized Lipid-Based Carotenoid Liquid Supplementation and AREDS-2 Formula', 'micronized lipid-based carotenoid supplement, Lumega-Z (LM), or the PreserVision Age-Related Eye Disease Study 2 (AREDS-2) soft gel (PV', 'LM']","['visual acuity, dark adaptation recovery and contrast sensitivity', 'visual performance', 'Visual acuity, dark adaptation recovery and MPOD', 'macular pigment optical density (MPOD', 'contrast sensitivity function (CSF', 'CSF', 'Visual performance', 'Visual Function and Macular Carotenoid Changes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0035312', 'cui_str': 'Retinal drusen'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007271', 'cui_str': 'Carotinoid'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0015397', 'cui_str': 'Disorder of eye'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C2586580', 'cui_str': 'PreserVision'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0010985', 'cui_str': 'Dark adaptation'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C3850163', 'cui_str': 'Macular Pigment'}, {'cui': 'C0439164', 'cui_str': 'OD units'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0007271', 'cui_str': 'Carotinoid'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",79.0,0.0697274,The LM group demonstrated statistically significant improvements in contrast sensitivity function (CSF) in both eyes at six months ( p < 0.001).,"[{'ForeName': 'Pinakin Gunvant', 'Initials': 'PG', 'LastName': 'Davey', 'Affiliation': 'College of Optometry, Western University of Health Sciences, Pomona, CA 91766, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Henderson', 'Affiliation': 'Eye Clinic of Austin, Austin, TX 78731, USA.'}, {'ForeName': 'Drake W', 'Initials': 'DW', 'LastName': 'Lem', 'Affiliation': 'College of Optometry, Western University of Health Sciences, Pomona, CA 91766, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Weis', 'Affiliation': 'Eye Clinic of Austin, Austin, TX 78731, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Amonoo-Monney', 'Affiliation': 'College of Optometry, Western University of Health Sciences, Pomona, CA 91766, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Evans', 'Affiliation': 'VectorVision/Guardion Health Sciences, San Diego, CA 92128, USA.'}]",Nutrients,['10.3390/nu12113271'] 939,33114585,The Anabolic Response to Dietary Protein Is Not Limited by the Maximal Stimulation of Protein Synthesis in Healthy Older Adults: A Randomized Crossover Trial.,"We have recently demonstrated in young adults that an anabolic response with mixed meal protein intake above ~35 g/meal, previously recognized as an ""optimal"" protein dose, was further stimulated. However, it is unknown if this applies to older adults. We therefore examined anabolic response to a mixed meal containing either 35 g (MOD, moderate amount of protein) or 70 g (HIGH, high amount of protein) in a randomized cross-over metabolic study in older adults ( n = 8). Primed continuous infusions of L-[ 2 H 5 ] phenylalanine and L-[ 2 H 2 ]tyrosine were performed to determine whole-body protein kinetics and muscle protein fractional synthesis rate (MPS) in basal fasted and fed states. Whole-body protein kinetics (NB, net protein balance; PS, protein synthesis; PB, protein breakdown) and MPS was expressed as changes from the baseline post-absorptive state. Consistent with our previous findings in young adults, both feedings resulted in a positive NB, with HIGH being more positive than MOD. Furthermore, NB (expressed as g protein∙240 min) increased linearly with an increasing amount of protein intake, expressed relative to lean body mass. The positive NB was achieved due mainly to the suppression of PB in both MOD and to a greater extent HIGH, while PS was only increased in HIGH. Consistent with the whole-body data, MPS was significantly higher in HIGH than MOD. Plasma concentrations of essential amino acids and insulin were greater in HIGH vs. MOD. We conclude that in the context of mixed meals, whole-body anabolic response linearly increases with increasing protein intake primarily through the suppression of PB, and MPS was further stimulated with protein intake above the previously considered ""optimal"" protein dose in older adults.",2020,Plasma concentrations of essential amino acids and insulin were greater in HIGH vs. MOD.,"['young adults that an anabolic response with mixed meal protein intake above ~35', 'Healthy Older Adults', 'older adults', 'older adults ( n = 8']","['L', 'phenylalanine and L', 'mixed meal containing either 35 g (MOD, moderate amount of protein) or 70 g (HIGH, high amount of protein']","['Plasma concentrations of essential amino acids and insulin', 'whole-body protein kinetics and muscle protein fractional synthesis rate (MPS']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0002845', 'cui_str': 'Anabolic steroid'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002525', 'cui_str': 'Essential amino acid'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0026832', 'cui_str': 'Muscle Protein'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",,0.0139623,Plasma concentrations of essential amino acids and insulin were greater in HIGH vs. MOD.,"[{'ForeName': 'Sanghee', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Lee Gil Ya Cancer and Diabetes Institute, Gachon University, Incheon 21999, Korea.'}, {'ForeName': 'Jiwoong', 'Initials': 'J', 'LastName': 'Jang', 'Affiliation': 'Lee Gil Ya Cancer and Diabetes Institute, Gachon University, Incheon 21999, Korea.'}, {'ForeName': 'Myung Dong', 'Initials': 'MD', 'LastName': 'Choi', 'Affiliation': 'Department of Human Movement Science, Oakland University, Rochester, MI 48309, USA.'}, {'ForeName': 'Yun-A', 'Initials': 'YA', 'LastName': 'Shin', 'Affiliation': 'Department of Prescription & Rehabilitation of Exercise, Dankook University, Cheonan 31116, Korea.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Schutzler', 'Affiliation': 'Center for Translational Research in Aging and Longevity, Department of Geriatrics, Donald W. Reynolds Institute on Aging, University of Arkansas for Medical Sciences, Little Rock, AR 72205, USA.'}, {'ForeName': 'Gohar', 'Initials': 'G', 'LastName': 'Azhar', 'Affiliation': 'Center for Translational Research in Aging and Longevity, Department of Geriatrics, Donald W. Reynolds Institute on Aging, University of Arkansas for Medical Sciences, Little Rock, AR 72205, USA.'}, {'ForeName': 'Arny A', 'Initials': 'AA', 'LastName': 'Ferrando', 'Affiliation': 'Center for Translational Research in Aging and Longevity, Department of Geriatrics, Donald W. Reynolds Institute on Aging, University of Arkansas for Medical Sciences, Little Rock, AR 72205, USA.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Wolfe', 'Affiliation': 'Center for Translational Research in Aging and Longevity, Department of Geriatrics, Donald W. Reynolds Institute on Aging, University of Arkansas for Medical Sciences, Little Rock, AR 72205, USA.'}, {'ForeName': 'Il-Young', 'Initials': 'IY', 'LastName': 'Kim', 'Affiliation': 'Lee Gil Ya Cancer and Diabetes Institute, Gachon University, Incheon 21999, Korea.'}]",Nutrients,['10.3390/nu12113276'] 940,33143121,The Effect of Soluble Fiber Dextrin on Subjective and Physiological Markers of Appetite: A Randomized Trial.,"Obesity is a leading public health problem throughout the world. The development of foods that increase satiety and reduce food may aid weight management. This study determined the effect of consuming soluble fiber dextrin (SFD) on appetite, appetitive hormones, breath hydrogen and food intake in adults. Forty-three participants completed this study. For each treatment, 50% of the SFD was provided in liquid form as part of breakfast and 50% in solid form as a morning snack. Appetite questionnaires, blood and breath samples were collected immediately before breakfast and at regular intervals during the test session. The participants consumed an ad libitum lunch meal, afternoon snack and dinner meal, and the amount eaten was recorded. Following dinner, participants left the laboratory but were required to keep a diet diary for the remainder of the day. Breath hydrogen concentration was significantly higher following the consumption of SFD compared to control ( p < 0.05). There was no observed overall treatment effect of consuming SFD on GLP-1 (Glucagon-Like-Peptide-1), ghrelin, CCK-8 (Cholecystokinin) or PYY 3-36 (Petptide YY) ( p > 0.05). Moreover, consuming foods containing SFD had no effect on subjective appetite or food intake ( p > 0.05). Consuming foods containing SFD increased breath hydrogen but did not influence food intake, appetite or appetitive hormones. However, the limitations of this study may have individually or collectively masked an effect of SFD on food intake and appetite.",2020,There was no observed overall treatment effect of consuming SFD on GLP-1,"['adults', 'Forty-three participants completed this study']","['consuming soluble fiber dextrin (SFD', 'Soluble Fiber Dextrin']","['Appetite questionnaires, blood and breath samples', 'appetite, appetitive hormones, breath hydrogen and food intake', 'Glucagon-Like-Peptide-1), ghrelin, CCK-8 (Cholecystokinin', 'subjective appetite or food intake', 'food intake, appetite or appetitive hormones', 'breath hydrogen', 'GLP-1', 'Subjective and Physiological Markers of Appetite', 'Breath hydrogen concentration']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C3661727', 'cui_str': 'Soluble fiber'}, {'cui': 'C0011808', 'cui_str': 'Dextrins'}]","[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0037167', 'cui_str': 'Sincalide'}, {'cui': 'C0008328', 'cui_str': 'Cholecystokinin'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",43.0,0.0769797,There was no observed overall treatment effect of consuming SFD on GLP-1,"[{'ForeName': 'Christine H', 'Initials': 'CH', 'LastName': 'Emilien', 'Affiliation': 'Department of Food Science and Human Nutrition, Iowa State University, Ames, IA 50011, USA.'}, {'ForeName': 'Walter H', 'Initials': 'WH', 'LastName': 'Hsu', 'Affiliation': 'Department of Biomedical Sciences, Iowa State University, Ames, IA 50011, USA.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Hollis', 'Affiliation': 'Department of Food Science and Human Nutrition, Iowa State University, Ames, IA 50011, USA.'}]",Nutrients,['10.3390/nu12113341'] 941,33151321,"Intense Simulation-Based Surgical Education for Manual Small-Incision Cataract Surgery: The Ophthalmic Learning and Improvement Initiative in Cataract Surgery Randomized Clinical Trial in Kenya, Tanzania, Uganda, and Zimbabwe.","Importance Cataracts account for 40% of cases of blindness globally, with surgery the only treatment. Objective To determine whether adding simulation-based cataract surgical training to conventional training results in improved acquisition of surgical skills among trainees. Design, Setting, and Participants A multicenter, investigator-masked, parallel-group, randomized clinical educational-intervention trial was conducted at 5 university hospital training institutions in Kenya, Tanzania, Uganda, and Zimbabwe from October 1, 2017, to September 30, 2019, with a follow-up of 15 months. Fifty-two trainee ophthalmologists were assessed for eligibility (required no prior cataract surgery as primary surgeon); 50 were recruited and randomized. Those assessing outcomes of surgical competency were masked to group assignment. Analysis was performed on an intention-to-treat basis. Interventions The intervention group received a 5-day simulation-based cataract surgical training course, in addition to standard surgical training. The control group received standard training only, without a placebo intervention; however, those in the control group received the intervention training after the initial 12-month follow-up period. Main Outcomes and Measures The primary outcome measure was overall surgical competency at 3 months, which was assessed with a validated competency assessment rubric. Secondary outcomes included surgical competence at 1 year and quantity and outcomes (including visual acuity and posterior capsule rupture) of cataract surgical procedures performed during a 1-year period. Results Among the 50 participants (26 women [52.0%]; mean [SD] age, 32.3 [4.6] years), 25 were randomized to the intervention group, and 25 were randomized to the control group, with 1 dropout. Forty-nine participants were included in the final intention-to-treat analysis. Baseline characteristics were balanced. The participants in the intervention group had higher scores at 3 months compared with the participants in the control group, after adjusting for baseline assessment rubric score. The participants in the intervention group were estimated to have scores 16.6 points (out of 40) higher (95% CI, 14.4-18.7; P < .001) at 3 months than the participants in the control group. The participants in the intervention group performed a mean of 21.5 cataract surgical procedures in the year after the training, while the participants in the control group performed a mean of 8.5 cataract surgical procedures (mean difference, 13.0; 95% CI, 3.9-22.2; P < .001). Posterior capsule rupture rates (an important complication) were 7.8% (42 of 537) for the intervention group and 26.6% (54 of 203) for the control group (difference, 18.8%; 95% CI, 12.3%-25.3%; P < .001). Conclusions and Relevance This randomized clinical trial provides evidence that intense simulation-based cataract surgical education facilitates the rapid acquisition of surgical competence and maximizes patient safety. Trial Registration Pan-African Clinical Trial Registry, number PACTR201803002159198.",2021,"Posterior capsule rupture rates (an important complication) were 7.8% (42 of 537) for the intervention group and 26.6% (54 of 203) for the control group (difference, 18.8%; 95% CI, 12.3%-25.3%; P < .001). ","['Fifty-two trainee ophthalmologists were assessed for eligibility (required no prior cataract surgery as primary surgeon); 50 were recruited and randomized', '50 participants (26 women [52.0%]; mean [SD] age, 32.3 [4.6] years', 'trainees', 'Forty-nine participants were included in the final intention-to-treat analysis']","['standard training only, without a placebo intervention', 'Intense Simulation-Based Surgical Education for Manual Small-Incision Cataract Surgery', '5-day simulation-based cataract surgical training course, in addition to standard surgical training', 'intervention training', 'simulation-based cataract surgical training to conventional training']","['surgical competence at 1 year and quantity and outcomes (including visual acuity and posterior capsule rupture) of cataract surgical procedures performed during a 1-year period', 'overall surgical competency', 'Posterior capsule rupture rates', 'acquisition of surgical skills']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C1704292', 'cui_str': 'Ophthalmologist'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1535895', 'cui_str': 'Posterior capsule rupture'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",49.0,0.223161,"Posterior capsule rupture rates (an important complication) were 7.8% (42 of 537) for the intervention group and 26.6% (54 of 203) for the control group (difference, 18.8%; 95% CI, 12.3%-25.3%; P < .001). ","[{'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Dean', 'Affiliation': 'International Centre for Eye Health, Clinical Research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Gichuhi', 'Affiliation': 'Department of Ophthalmology, University of Nairobi, Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Buchan', 'Affiliation': 'International Centre for Eye Health, Clinical Research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Makupa', 'Affiliation': 'Kilimanjaro Christian Medical Centre, Moshi, Tanzania.'}, {'ForeName': 'Agrippa', 'Initials': 'A', 'LastName': 'Mukome', 'Affiliation': 'Department of Ophthalmology, Parirenyatwa Hospitals, University of Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'Juliet', 'Initials': 'J', 'LastName': 'Otiti-Sengeri', 'Affiliation': 'Department of Ophthalmology, Makerere University School of Medicine, Kampala, Uganda.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Arunga', 'Affiliation': 'International Centre for Eye Health, Clinical Research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Subhashis', 'Initials': 'S', 'LastName': 'Mukherjee', 'Affiliation': 'Bristol Eye Hospital, Bristol, United Kingdom.'}, {'ForeName': 'Min J', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': 'Tropical Epidemiology Group, Faculty of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Lloyd', 'Initials': 'L', 'LastName': 'Harrison-Williams', 'Affiliation': 'Makeni Regional Hospital, Bombali, Sierra Leone.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'MacLeod', 'Affiliation': 'Tropical Epidemiology Group, Faculty of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Cook', 'Affiliation': 'Division of Ophthalmology, Groote Schuur Hospital, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Burton', 'Affiliation': 'International Centre for Eye Health, Clinical Research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.4718'] 942,33151330,Cost-effectiveness of digital cognitive behavioral therapy (Sleepio) for insomnia: a Markov simulation model in the United States.,"STUDY OBJECTIVES To examine the cost-effectiveness and potential net monetary benefit (NMB) of a fully automated digital cognitive behavioral therapy (CBT) intervention for insomnia compared with no insomnia treatment in the United States (US). Similar relative comparisons were made for pharmacotherapy and clinician-delivered CBT (individual and group). METHODS We simulated a Markov model of 100,000 individuals using parameters calibrated from the literature including direct (treatment) and indirect costs (e.g. insomnia-related healthcare expenditure and lost workplace productivity). Health utility estimates were converted into quality-adjusted life years (QALYs) and one QALY was worth $50,000. Simulated individuals were randomized equally to one of five arms (digital CBT, pharmacotherapy, individual CBT, group CBT, or no insomnia treatment). Sensitivity was assessed by bootstrapping the calibrated parameters. Cost estimates were expressed in 2019 US dollars. RESULTS Digital CBT was cost beneficial when compared with no insomnia treatment and had a positive NMB of $681.06 (per individual over 6 months). Bootstrap sensitivity analysis demonstrated that the NMB was positive in 94.7% of simulations. Relative to other insomnia treatments, digital CBT was the most cost-effective treatment because it generated the smallest incremental cost-effectiveness ratio (-$3,124.73). CONCLUSIONS Digital CBT was the most cost-effective insomnia treatment followed by group CBT, pharmacotherapy, and individual CBT. It is financially prudent and beneficial from a societal perspective to utilize automated digital CBT to treat insomnia at a population scale.",2021,"RESULTS Digital CBT was cost-beneficial when compared with no insomnia treatment and had a positive net monetary benefit of $681.06 (per individual over 6-months).","['insomnia', 'insomnia compared with no insomnia treatment in the United States (US']","['digital CBT (Sleepio', 'fully automated digital cognitive behavioral therapy (CBT) intervention', 'CBT, pharmacotherapy, individual CBT, group CBT or no insomnia treatment']","['Cost estimates', 'cost-effectiveness', 'Sensitivity']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",100000.0,0.0263307,"RESULTS Digital CBT was cost-beneficial when compared with no insomnia treatment and had a positive net monetary benefit of $681.06 (per individual over 6-months).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Darden', 'Affiliation': 'Carey Business School, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Colin A', 'Initials': 'CA', 'LastName': 'Espie', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jenna R', 'Initials': 'JR', 'LastName': 'Carl', 'Affiliation': 'Big Health Inc., London, UK.'}, {'ForeName': 'Alasdair L', 'Initials': 'AL', 'LastName': 'Henry', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Kanady', 'Affiliation': 'Big Health Inc., London, UK.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Krystal', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Miller', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}]",Sleep,['10.1093/sleep/zsaa223'] 943,33148481,Interaction of serum calcium and folic acid treatment on first stroke in hypertensive males.,"BACKGROUND & AIMS The role of serum calcium on the risk of stroke is still uncertain. We aimed to evaluate the effect of serum calcium on first stroke risk, and on the efficacy of folic acid treatment in prevention of first stroke among hypertensive patients. METHODS Our analyses included a total of 19,644 eligible hypertensive adults from the China Stroke Primary Prevention Trial (CSPPT). In the CSPPT, a total of 20,702 hypertensive patients were randomly assigned to a double-blind, daily treatment with either 10 mg enalapril and 0.8 mg folic acid or 10 mg enalapril alone. The primary outcome was a first stroke. RESULTS Over a median of 4.5 years, among those not receiving folic acid, a significantly higher risk of first stroke was found in hypertensive males with baseline albumin-corrected serum calcium ≥2.43 mmol/L (median) (vs. <2.43 mmol/L; 6.5% vs. 2.3%; adjusted HR, 2.47; 95% CI: 1.72, 3.55). For those with enalapril and folic acid treatment, compared with the enalapril only group, the risk of first stroke was reduced from 6.5% to 3.0% (adjusted HR, 0.49; 95% CI: 0.35, 0.68) in hypertensive males with baseline albumin-corrected serum calcium ≥2.43 mmol/L, whereas there was no significant effect among hypertensive males with baseline albumin-corrected serum calcium <2.43 mmol/L. However, among hypertensive females, serum calcium did not significantly affect the first stroke risk and the efficacy of folic acid in prevention of first stroke. CONCLUSIONS Among Chinese hypertensive males, those with elevated serum calcium levels had increased risk of first stroke, and this risk was reduced by 51% with folic acid treatment.",2021,"However, among hypertensive females, serum calcium did not significantly affect the first stroke risk and the efficacy of folic acid in prevention of first stroke. ","['hypertensive males', '20,702 hypertensive patients', 'Chinese hypertensive males', 'hypertensive patients', '19,644 eligible hypertensive adults from the China Stroke Primary Prevention Trial (CSPPT']","['folic acid', 'folic acid treatment', 'enalapril and folic acid', 'serum calcium and folic acid treatment', 'serum calcium', 'enalapril and 0.8\xa0mg folic acid or 10\xa0mg enalapril alone', 'enalapril']","['first stroke', 'risk of first stroke']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0033144', 'cui_str': 'Primary prevention'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C4517481', 'cui_str': '0.8'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",20702.0,0.0502796,"However, among hypertensive females, serum calcium did not significantly affect the first stroke risk and the efficacy of folic acid in prevention of first stroke. ","[{'ForeName': 'Hongxu', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China; National Clinical Research Center for Kidney Disease, Guangzhou 510515, China; State Key Laboratory for Organ Failure Research, Guangdong Provincial Key Laboratory of Renal Failure Research, Guangzhou 510515, China; Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou 510515, China; Institute for Biomedicine, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China; National Clinical Research Center for Kidney Disease, Guangzhou 510515, China; State Key Laboratory for Organ Failure Research, Guangdong Provincial Key Laboratory of Renal Failure Research, Guangzhou 510515, China; Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou 510515, China.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China; National Clinical Research Center for Kidney Disease, Guangzhou 510515, China; State Key Laboratory for Organ Failure Research, Guangdong Provincial Key Laboratory of Renal Failure Research, Guangzhou 510515, China; Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou 510515, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing 100034, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing 100034, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Liang', 'Affiliation': 'Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China; National Clinical Research Center for Kidney Disease, Guangzhou 510515, China; State Key Laboratory for Organ Failure Research, Guangdong Provincial Key Laboratory of Renal Failure Research, Guangzhou 510515, China; Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou 510515, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Nie', 'Affiliation': 'Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China; National Clinical Research Center for Kidney Disease, Guangzhou 510515, China; State Key Laboratory for Organ Failure Research, Guangdong Provincial Key Laboratory of Renal Failure Research, Guangzhou 510515, China; Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou 510515, China.'}, {'ForeName': 'Binyan', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Institute for Biomedicine, Anhui Medical University, Hefei 230032, China; Shenzhen Evergreen Medical Institute, Shenzhen 518057, China.'}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Population, Family and Reproductive Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD 21205-2179, USA.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huo', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing 100034, China.'}, {'ForeName': 'Fan Fan', 'Initials': 'FF', 'LastName': 'Hou', 'Affiliation': 'Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China; National Clinical Research Center for Kidney Disease, Guangzhou 510515, China; State Key Laboratory for Organ Failure Research, Guangdong Provincial Key Laboratory of Renal Failure Research, Guangzhou 510515, China; Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou 510515, China.'}, {'ForeName': 'Xiping', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China; National Clinical Research Center for Kidney Disease, Guangzhou 510515, China; State Key Laboratory for Organ Failure Research, Guangdong Provincial Key Laboratory of Renal Failure Research, Guangzhou 510515, China; Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou 510515, China. Electronic address: xipingxu126@126.com.'}, {'ForeName': 'Xianhui', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China; National Clinical Research Center for Kidney Disease, Guangzhou 510515, China; State Key Laboratory for Organ Failure Research, Guangdong Provincial Key Laboratory of Renal Failure Research, Guangzhou 510515, China; Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou 510515, China. Electronic address: pharmaqin@126.com.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.10.033'] 944,33152354,Preclinical neurorehabilitation with environmental enrichment confers cognitive and histological benefits in a model of pediatric asphyxial cardiac arrest.,"Pediatric asphyxial cardiac arrest (ACA) often leaves children with physical, cognitive, and emotional disabilities that affect overall quality of life, yet rehabilitation is neither routinely nor systematically provided. Environmental enrichment (EE) is considered a preclinical model of neurorehabilitation and thus we sought to investigate its efficacy in our established model of pediatric ACA. Male Sprague-Dawley rat pups (post-natal day 16-18) were randomly assigned to ACA (9.5 min) or Sham injury. After resuscitation, the rats were assigned to 21 days of EE or standard (STD) housing during which time motor, cognitive, and anxiety-like (i.e., affective) outcomes were assessed. Hippocampal CA 1 cells were quantified on post-operative day-22. Both ACA + STD and ACA + EE performed worse on beam-balance vs. Sham controls (p < 0.05) and did not differ from one another overall (p > 0.05); however, a single day analysis on the last day of testing revealed that the ACA + EE group performed better than the ACA + STD group (p < 0.05) and did not differ from the Sham controls (p > 0.05). Both Sham groups performed better than ACA + STD (p < 0.05) but did not differ from ACA + EE (p > 0.05) in the open field test. Spatial learning and declarative memory were improved and CA 1 neuronal loss was attenuated in the ACA + EE vs. ACA + STD group (p < 0.05). Collectively, the data suggest that providing rehabilitation after pediatric ACA can reduce histopathology and improve motor and cognitive ability.",2021,Both Sham groups performed better than ACA + STD (p < 0.05) but did not differ from ACA + EE (p > 0.05) in the open field test.,"['Male Sprague-Dawley rat pups (post-natal day 16-18', 'Pediatric asphyxial cardiac arrest (ACA) often leaves children with physical, cognitive, and emotional disabilities']","['Environmental enrichment (EE', 'ACA']","['motor and cognitive ability', 'CA 1 neuronal loss', 'Spatial learning and declarative memory']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0034715', 'cui_str': 'Sprague-Dawley rat'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0454729', 'cui_str': 'Natal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]","[{'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}]","[{'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0582587', 'cui_str': 'Visual learning'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",,0.0463264,Both Sham groups performed better than ACA + STD (p < 0.05) but did not differ from ACA + EE (p > 0.05) in the open field test.,"[{'ForeName': 'Mioara D', 'Initials': 'MD', 'LastName': 'Manole', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Pediatrics, University of Pittsburgh, Pittsburgh, PA, United States of America. Electronic address: manomd@upmc.edu.'}, {'ForeName': 'Marcus J A', 'Initials': 'MJA', 'LastName': 'Hook', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; University of Bath, Claverton Down, Bath BA2 7AY, UK.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Nicholas', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Pediatrics, University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Brittany P', 'Initials': 'BP', 'LastName': 'Nelson', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Pediatrics, University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Adanna C', 'Initials': 'AC', 'LastName': 'Liu', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Quinn C', 'Initials': 'QC', 'LastName': 'Stezoski', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Rowley', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Pediatrics, University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Cheng', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Physical Medicine & Rehabilitation, University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Alexander', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Critical Care, Medicine University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Eleni H', 'Initials': 'EH', 'LastName': 'Moschonas', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Physical Medicine & Rehabilitation, University of Pittsburgh, Pittsburgh, PA, United States of America; Center for Neuroscience, University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Corina O', 'Initials': 'CO', 'LastName': 'Bondi', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Physical Medicine & Rehabilitation, University of Pittsburgh, Pittsburgh, PA, United States of America; Center for Neuroscience, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Neurobiology, University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Kline', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Physical Medicine & Rehabilitation, University of Pittsburgh, Pittsburgh, PA, United States of America; Center for Neuroscience, University of Pittsburgh, Pittsburgh, PA, United States of America; Center for the Neural Basis of Cognition, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Critical Care, Medicine University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Psychology, University of Pittsburgh, Pittsburgh, PA, United States of America. Electronic address: klineae@upmc.edu.'}]",Experimental neurology,['10.1016/j.expneurol.2020.113522'] 945,33153313,Age Is Not a Barrier: Older Adults With Cancer Derive Similar Benefit in a Randomized Controlled Trial of a Remote Symptom Monitoring Intervention Compared With Younger Adults.,"This study investigated a remote symptom monitoring intervention to examine if older participants with cancer received a similar magnitude of benefit compared with younger adults with cancer. We analyzed a longitudinal symptom monitoring intervention for 358 participants beginning a new course of chemotherapy treatment in community and academic oncology practices. The study design was a randomized control trial; participants were randomized to the intervention or usual care, the intervention was delivered during daily automated coaching. Older adults with moderate and severe symptoms derived similar benefit as those adults younger than 60 years of age, adherence to the study protocol which involved daily calls was high. There was no significant difference between the 2 age categories; on average, older adult participants made 88% of expected daily calls and younger adult participants made 90% of expected daily calls. Our results challenge the perception that older adults are unwilling or unable to use a technological tool such as interactive voice response and suggest that patient utilization may be guided by other factors, such as ease of use and perceived benefit from the intervention.",2020,"There was no significant difference between the 2 age categories; on average, older adult participants made 88% of expected daily calls and younger adult participants made 90% of expected daily calls.","['older adults', 'older participants with cancer', 'Older adults with moderate and severe symptoms', '358 participants beginning a new course of chemotherapy treatment in community and academic oncology practices', 'younger adults with cancer']","['intervention or usual care, the intervention was delivered during daily automated coaching', 'Remote Symptom Monitoring Intervention', 'remote symptom monitoring intervention']",[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0436345', 'cui_str': 'Symptom severe'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]",[],358.0,0.0886538,"There was no significant difference between the 2 age categories; on average, older adult participants made 88% of expected daily calls and younger adult participants made 90% of expected daily calls.","[{'ForeName': 'Lorinda A', 'Initials': 'LA', 'LastName': 'Coombs', 'Affiliation': 'School of Nursing, University of North Carolina at Chapel Hill, NC USA.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Ellington', 'Affiliation': 'University of Utah College of Nursing, Salt Lake City, UT, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Fagerlin', 'Affiliation': 'Department of Population Health Sciences, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Kathi', 'Initials': 'K', 'LastName': 'Mooney', 'Affiliation': 'University of Utah College of Nursing, Salt Lake City, UT, USA.'}]",Cancer control : journal of the Moffitt Cancer Center,['10.1177/1073274820968878'] 946,33111247,Exercise Enhances the Effect of Bariatric Surgery in Markers of Cardiac Autonomic Function.,"BACKGROUND Bariatric surgery improves cardiovascular health, which might be partly ascribed to beneficial alterations in the autonomic nervous system. However, it is currently unknown whether benefits from surgery on cardiac autonomic regulation in post-bariatric patients can be further improved by adjuvant therapies, namely exercise. We investigated the effects of a 6-month exercise training program on cardiac autonomic responses in women undergoing bariatric surgery. METHODS Sixty-two women eligible for bariatric surgery were randomly allocated to either standard of care (control) or an exercise training intervention. At baseline (PRE) and 3 (POST3) and 9 (POST9) months after surgery, we assessed chronotropic response to exercise (CR%; i.e., percentage change in heart rate from rest to peak exercise) and heart rate recovery (HRR30s, HRR60s, and HRR120s; i.e., decay of heart rate at 30, 60, and 120 s post exercise) after a maximal exercise test. RESULTS Between-group absolute changes revealed higher CR% (Δ = 8.56%, CI95% 0.22-19.90, P = 0.04), HRR30s (Δ = 12.98 beat/min, CI95% 4.29-21.67, P = 0.01), HRR60s (Δ = 22.95 beat/min, CI95% 11.72-34.18, P = 0.01), and HRR120s (Δ = 34.54 beat/min, CI95% 19.91-49.17, P < 0.01) in the exercised vs. non-exercised group. CONCLUSIONS Our findings demonstrate that exercise training enhanced the benefits of bariatric surgery on cardiac autonomic regulation. These results highlight the relevance of exercise training as a treatment for post-bariatric patients, ensuring optimal cardiovascular outcomes.",2021,"RESULTS Between-group absolute changes revealed higher CR% (Δ = 8.56%, CI95% 0.22-19.90, P = 0.04), HRR30s (Δ = 12.98 beat/min, CI95% 4.29-21.67, P = 0.01), HRR60s (Δ = 22.95 beat/min, CI95% 11.72-34.18, P = 0.01), and HRR120s (Δ = 34.54 beat/min, CI95% 19.91-49.17, P < 0.01) in the exercised vs. non-exercised group. ","['women undergoing bariatric surgery', 'Sixty-two women eligible for bariatric surgery']","['exercise training program', 'Bariatric Surgery', 'exercise training', 'standard of care (control) or an exercise training intervention']","['cardiac autonomic regulation', 'HRR30s', 'CR', 'chronotropic response to exercise (CR%; i.e., percentage change in heart rate from rest to peak exercise) and heart rate recovery (HRR30s, HRR60s, and HRR120s; i.e., decay of heart rate', 'HRR60s', 'cardiovascular health', 'HRR120s', 'cardiac autonomic responses']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C4517835', 'cui_str': '62'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",62.0,0.0582273,"RESULTS Between-group absolute changes revealed higher CR% (Δ = 8.56%, CI95% 0.22-19.90, P = 0.04), HRR30s (Δ = 12.98 beat/min, CI95% 4.29-21.67, P = 0.01), HRR60s (Δ = 22.95 beat/min, CI95% 11.72-34.18, P = 0.01), and HRR120s (Δ = 34.54 beat/min, CI95% 19.91-49.17, P < 0.01) in the exercised vs. non-exercised group. ","[{'ForeName': 'Saulo', 'Initials': 'S', 'LastName': 'Gil', 'Affiliation': 'Applied Physiology & Nutrition Research Group; Laboratory of Assessment and Conditioning in Rheumatology; Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Tiago', 'Initials': 'T', 'LastName': 'Peçanha', 'Affiliation': 'Applied Physiology & Nutrition Research Group; Laboratory of Assessment and Conditioning in Rheumatology; Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Wagner S', 'Initials': 'WS', 'LastName': 'Dantas', 'Affiliation': 'Applied Physiology & Nutrition Research Group; Laboratory of Assessment and Conditioning in Rheumatology; Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Igor Hisashi', 'Initials': 'IH', 'LastName': 'Murai', 'Affiliation': 'Applied Physiology & Nutrition Research Group; Laboratory of Assessment and Conditioning in Rheumatology; Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Carlos Alberto Abujabra', 'Initials': 'CAA', 'LastName': 'Merege-Filho', 'Affiliation': 'Applied Physiology & Nutrition Research Group; Laboratory of Assessment and Conditioning in Rheumatology; Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Ana Lúcia', 'Initials': 'AL', 'LastName': 'de Sá-Pinto', 'Affiliation': 'Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Rosa Maria Rodrigues', 'Initials': 'RMR', 'LastName': 'Pereira', 'Affiliation': 'Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'de Cleva', 'Affiliation': 'Department of Digestive Surgery, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Marco Aurélio', 'Initials': 'MA', 'LastName': 'Santo', 'Affiliation': 'Department of Digestive Surgery, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Diego Augusto Nunes', 'Initials': 'DAN', 'LastName': 'Rezende', 'Affiliation': 'Applied Physiology & Nutrition Research Group; Laboratory of Assessment and Conditioning in Rheumatology; Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Kirwan', 'Affiliation': 'Integrated Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Gualano', 'Affiliation': 'Applied Physiology & Nutrition Research Group; Laboratory of Assessment and Conditioning in Rheumatology; Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Hamilton', 'Initials': 'H', 'LastName': 'Roschel', 'Affiliation': 'Applied Physiology & Nutrition Research Group; Laboratory of Assessment and Conditioning in Rheumatology; Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil. hars@usp.br.'}]",Obesity surgery,['10.1007/s11695-020-05053-7'] 947,33112363,Effectiveness of Home-Based Mobile Guided Cardiac Rehabilitation as Alternative Strategy for Nonparticipation in Clinic-Based Cardiac Rehabilitation Among Elderly Patients in Europe: A Randomized Clinical Trial.,"Importance Although nonparticipation in cardiac rehabilitation is known to increase cardiovascular mortality and hospital readmissions, more than half of patients with coronary artery disease in Europe are not participating in cardiac rehabilitation. Objective To assess whether a 6-month guided mobile cardiac rehabilitation (MCR) program is an effective therapy for elderly patients who decline participation in cardiac rehabilitation. Design, Setting, and Participants Patients were enrolled in this parallel multicenter randomized clinical trial from November 11, 2015, to January 3, 2018, and follow-up was completed on January 17, 2019, in a secondary care system with 6 cardiac institutions across 5 European countries. Researchers assessing primary outcome were masked for group assignment. A total of 4236 patients were identified with a recent diagnosis of acute coronary syndrome, coronary revascularization, or surgical or percutaneous treatment for valvular disease, or documented coronary artery disease, of whom 996 declined to start cardiac rehabilitation. Subsequently, 179 patients who met the inclusion and exclusion criteria consented to participate in the European Study on Effectiveness and Sustainability of Current Cardiac Rehabilitation Programmes in the Elderly trial. Data were analyzed from January 21 to October 11, 2019. Interventions Six months of home-based cardiac rehabilitation with telemonitoring and coaching based on motivational interviewing was used to stimulate patients to reach exercise goals. Control patients did not receive any form of cardiac rehabilitation throughout the study period. Main Outcomes and Measures The primary outcome parameter was peak oxygen uptake (Vo2peak) after 6 months. Results Among 179 patients randomized (145 male [81%]; median age, 72 [range, 65-87] years), 159 (89%) were eligible for primary end point analysis. Follow-up at 1 year was completed for 151 patients (84%). Peak oxygen uptake improved in the MCR group (n = 89) at 6 and 12 months (1.6 [95% CI, 0.9-2.4] mL/kg-1/min-1 and 1.2 [95% CI, 0.4-2.0] mL/kg-1/min-1, respectively), whereas there was no improvement in the control group (n = 90) (+0.2 [95% CI, -0.4 to 0.8] mL/kg-1/min-1 and +0.1 [95% CI, -0.5 to 0.7] mL/kg-1/min-1, respectively). Changes in Vo2peak were greater in the MCR vs control groups at 6 months (+1.2 [95% CI, 0.2 to 2.1] mL/kg-1/min-1) and 12 months (+0.9 [95% CI, 0.05 to 1.8] mL/kg-1/min-1). The incidence of adverse events was low and did not differ between the MCR and control groups. Conclusions and Relevance These results suggest that a 6-month home-based MCR program for patients 65 years or older with coronary artery disease or a valvular intervention was safe and beneficial in improving Vo2peak when compared with no cardiac rehabilitation. Trial Registration trialregister.nl Identifier: NL5168.",2021,"Peak oxygen uptake improved in the MCR group (n = 89) at 6 and 12 months (1.6 [95% CI, 0.9-2.4] mL/kg-1/min-1 and 1.2 [95% CI, 0.4-2.0] mL/kg-1/min-1, respectively), whereas there was no improvement in the control group (n = 90) (+0.2 [95% CI, -0.4 to 0.8] mL/kg-1/min-1 and +0.1 [95% CI, -0.5 to 0.7] mL/kg-1/min-1, respectively).","['Participants\n\n\nPatients were enrolled in this parallel multicenter randomized clinical trial from November 11, 2015, to January 3, 2018, and follow-up was completed on January 17, 2019, in a secondary care system with 6 cardiac institutions across 5 European countries', 'patients 65 years or older with coronary artery disease or a', '179 patients who met the inclusion and exclusion criteria consented to participate in the European Study on Effectiveness and Sustainability of Current Cardiac Rehabilitation Programmes in the Elderly trial', 'patients with coronary artery disease in Europe', '179 patients randomized (145 male [81%]; median age, 72 [range, 65-87] years), 159 (89%) were eligible for primary end point analysis', 'Elderly Patients in Europe', 'elderly patients who decline participation in cardiac rehabilitation', '4236 patients were identified with a recent diagnosis of acute coronary syndrome, coronary revascularization, or surgical or percutaneous treatment for valvular disease, or documented coronary artery disease, of whom 996 declined to start cardiac rehabilitation']","['Home-Based Mobile Guided Cardiac Rehabilitation', 'valvular intervention', 'telemonitoring and coaching based on motivational interviewing', 'guided mobile cardiac rehabilitation (MCR) program']","['Changes in Vo2peak', 'Peak oxygen uptake', 'cardiovascular mortality and hospital readmissions', 'peak oxygen uptake (Vo2peak', 'incidence of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0026265', 'cui_str': 'Mitral valve disorder'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",4236.0,0.13279,"Peak oxygen uptake improved in the MCR group (n = 89) at 6 and 12 months (1.6 [95% CI, 0.9-2.4] mL/kg-1/min-1 and 1.2 [95% CI, 0.4-2.0] mL/kg-1/min-1, respectively), whereas there was no improvement in the control group (n = 90) (+0.2 [95% CI, -0.4 to 0.8] mL/kg-1/min-1 and +0.1 [95% CI, -0.5 to 0.7] mL/kg-1/min-1, respectively).","[{'ForeName': 'Johan A', 'Initials': 'JA', 'LastName': 'Snoek', 'Affiliation': 'Isala Heart Center, Zwolle, the Netherlands.'}, {'ForeName': 'Eva I', 'Initials': 'EI', 'LastName': 'Prescott', 'Affiliation': 'Department of Cardiology, Bispebjerg Frederiksberg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Astrid E', 'Initials': 'AE', 'LastName': 'van der Velde', 'Affiliation': 'Isala Heart Center, Zwolle, the Netherlands.'}, {'ForeName': 'Thijs M H', 'Initials': 'TMH', 'LastName': 'Eijsvogels', 'Affiliation': 'Radboud Institute for Health Sciences, Department of Physiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Nicolai', 'Initials': 'N', 'LastName': 'Mikkelsen', 'Affiliation': 'Department of Cardiology, Bispebjerg Frederiksberg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Leonie F', 'Initials': 'LF', 'LastName': 'Prins', 'Affiliation': 'Diagram, Zwolle, the Netherlands.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Bruins', 'Affiliation': ''}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Meindersma', 'Affiliation': 'Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'José R', 'Initials': 'JR', 'LastName': 'González-Juanatey', 'Affiliation': 'Department of Cardiology, Hospital Clínico Universitario de Santiago, Instituto de Investigación Sanitaria, CIBER CV, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Peña-Gil', 'Affiliation': 'Department of Cardiology, Hospital Clínico Universitario de Santiago, Instituto de Investigación Sanitaria, CIBER CV, Madrid, Spain.'}, {'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'González-Salvado', 'Affiliation': 'Department of Cardiology, Hospital Clínico Universitario de Santiago, Instituto de Investigación Sanitaria, CIBER CV, Madrid, Spain.'}, {'ForeName': 'Feriel', 'Initials': 'F', 'LastName': 'Moatemri', 'Affiliation': 'Department of Cardiac Rehabilitation, Assistance Publique Hopitaux de Paris, Paris, France.'}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Iliou', 'Affiliation': 'Department of Cardiac Rehabilitation, Assistance Publique Hopitaux de Paris, Paris, France.'}, {'ForeName': 'Thimo', 'Initials': 'T', 'LastName': 'Marcin', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Prisca', 'Initials': 'P', 'LastName': 'Eser', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Wilhelm', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Arnoud W J', 'Initials': 'AWJ', 'LastName': ""Van't Hof"", 'Affiliation': 'Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (CARIM), Maastricht, the Netherlands.'}, {'ForeName': 'Ed P', 'Initials': 'EP', 'LastName': 'de Kluiver', 'Affiliation': 'Isala Heart Center, Zwolle, the Netherlands.'}]",JAMA cardiology,['10.1001/jamacardio.2020.5218'] 948,33118901,Assessing the challenges to women's access and implementation of text messages for nutrition behaviour change in rural Tanzania.,"OBJECTIVE This process evaluation aimed to understand factors affecting the implementation of a government-sponsored short message service (SMS) programme for delivering nutrition information to rural populations, including message access, acceptability and putting messages into action. DESIGN The study was nested within a larger randomised controlled trial. Cross-sectional data collection included structured surveys and in-depth interviews. Data were analysed for key trends and themes using Stata and ATLAS.ti software. SETTING The study took place in Tanzania's Mtwara region. PARTICIPANTS Surveys were conducted with 205 women and 93 men already enrolled in the randomised controlled trial. A sub-set of 30 women and 14 men participated in the in-depth interviews. RESULTS Among women relying on a spouse's phone, sharing arrangements impeded regular SMS access; men were commonly away from home, forgot to share SMS or did not share them in women's preferred way. Phone-owning women faced challenges related to charging their phones and defective handsets. Once SMS were delivered, most participants viewed them as trustworthy and comprehensible. However, economic conditions limited the feasibility of applying certain recommendations, such as feeding meat to toddlers. A sub-set of participants concurrently enrolled in an interpersonal counselling (IPC) intervention indicated that the SMS provided reminders of lessons learned during the IPC; yet, the SMS did not help participants contextualise information and overcome the challenges of putting that information into practice. CONCLUSIONS The challenges to accessing and implementing SMS services highlighted here suggest that such platforms may work well as one component of a comprehensive nutrition intervention, yet not as an isolated effort.",2021,"A sub-set of participants concurrently enrolled in an interpersonal counselling (IPC) intervention indicated that the SMS provided reminders of lessons learned during the IPC; yet, the SMS did not help participants contextualise information and overcome the challenges of putting that information into practice. ","['30 women and 14 men participated in the in-depth interviews', 'Surveys were conducted with 205 women and 93 men already enrolled in the randomised controlled trial', 'rural Tanzania']","['government-sponsored short message service (SMS) programme', 'interpersonal counselling (IPC) intervention']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}]","[{'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],205.0,0.100166,"A sub-set of participants concurrently enrolled in an interpersonal counselling (IPC) intervention indicated that the SMS provided reminders of lessons learned during the IPC; yet, the SMS did not help participants contextualise information and overcome the challenges of putting that information into practice. ","[{'ForeName': 'Jessica D', 'Initials': 'JD', 'LastName': 'Rothstein', 'Affiliation': 'Headquarters Nutrition Division, Helen Keller International, Washington, DC, USA.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Klemm', 'Affiliation': 'Headquarters Nutrition Division, Helen Keller International, Washington, DC, USA.'}, {'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Niyeha', 'Affiliation': 'Tanzania Country Office, Helen Keller International, Dar es Salaam, Tanzania.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Smith', 'Affiliation': 'Tanzania Country Office, Helen Keller International, Dar es Salaam, Tanzania.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Nordhagen', 'Affiliation': 'Global Alliance for Improved Nutrition, Geneva, Switzerland.'}]",Public health nutrition,['10.1017/S1368980020003742'] 949,33119363,Promoting collaborative psychiatric care decision-making in community mental health centers: Insights from a patient-centered comparative effectiveness trial.,"OBJECTIVE Mental health service-users face important medication decisions; yet not all are active participants in the decision-making process. Little is known about which technology-supported interventions might effectively promote collaborative decision-making in psychiatric care. We compared the effectiveness of two technology-supported collaborative care decision-making approaches. METHOD We used a cluster-randomized design with a mixed-methods approach. Participants were Medicaid-enrolled adults receiving psychiatric care in participating community mental health centers. Measurement-based care used computerized systematic symptom and medication screenings to inform provider decision-making. Person-centered care supported participants in completing computerized Health Reports and preparing to work with providers on collaborative decision-making about psychiatric care. Primary study outcomes included the patient experience of medication management and shared decision-making during psychiatric care. Analyses examined the impact of both approaches and explored moderating variables. We used qualitative methods to understand participation and implementation experiences. RESULTS Across 14 sites 2,363 participants enrolled (1,162 in measurement-based care, 1,201 in person-centered care). We observed statistically significant improvements in patient experience of medication management scores for both study arms; however, the clinical significance of this change was minor. We found no significant changes for shared decision-making. Qualitative interviews revealed a range of factors associated usefulness of intervention assessment, provider-service-user communication, and site-level logistics. CONCLUSIONS AND IMPLICATIONS FOR PRACTICE We observed modest positive findings related to our patient-centered outcomes. We identified important implementation facilitators and barriers that can inform the implementation of future comparative effectiveness patient-centered research. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,We found no significant changes for shared decision-making.,"['Participants were Medicaid-enrolled adults receiving psychiatric care in participating community mental health centers', 'community mental health centers', 'Across 14 sites 2,363 participants enrolled (1,162 in measurement-based care, 1,201 in person-centered care']",[],"['patient experience of medication management and shared decision-making during psychiatric care', 'patient experience of medication management scores']","[{'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0204523', 'cui_str': 'Psychiatric therapeutic procedure'}, {'cui': 'C0009474', 'cui_str': 'CMHC'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}]",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0204523', 'cui_str': 'Psychiatric therapeutic procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",2363.0,0.0605796,We found no significant changes for shared decision-making.,"[{'ForeName': 'Kim L', 'Initials': 'KL', 'LastName': 'MacDonald-Wilson', 'Affiliation': 'University of Pittsburgh Medical Center.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Williams', 'Affiliation': 'Center for High-Value Health Care.'}, {'ForeName': 'Cara E', 'Initials': 'CE', 'LastName': 'Nikolajski', 'Affiliation': 'Center for High-Value Health Care.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'McHugo', 'Affiliation': 'Geisel School of Medicine.'}, {'ForeName': 'Chaeryon', 'Initials': 'C', 'LastName': 'Kang', 'Affiliation': 'Department of Biostatistics.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Deegan', 'Affiliation': 'Pat Deegan and Associates, LLC.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Carpenter-Song', 'Affiliation': 'Geisel School of Medicine.'}, {'ForeName': 'Jane N', 'Initials': 'JN', 'LastName': 'Kogan', 'Affiliation': 'Center for High-Value Health Care.'}]",Psychiatric rehabilitation journal,['10.1037/prj0000455'] 950,33122393,Small Amounts of Dietary Medium-Chain Fatty Acids Protect Against Insulin Resistance During Caloric Excess in Humans.,"Medium-chain fatty acids (MCFAs) have in rodents been shown to have protective effects on glucose homeostasis during high-fat overfeeding. In this study, we investigated whether dietary MCFAs protect against insulin resistance induced by a hypercaloric high-fat diet in humans. Healthy, lean men ingested a eucaloric control diet and a 3-day hypercaloric high-fat diet (increase of 75% in energy, 81-83% energy [E%] from fat) in randomized order. For one group ( n = 8), the high-fat diet was enriched with saturated long-chain FAs (LCSFA-HFD), while the other group ( n = 9) ingested a matched diet, but with ∼30 g (5E%) saturated MCFAs (MCSFA-HFD) in substitution for a corresponding fraction of the saturated long-chain fatty acids (LCFAs). A hyperinsulinemic-euglycemic clamp with femoral arteriovenous balance and glucose tracer was applied after the control and hypercaloric diets. In LCSFA-HFD, whole-body insulin sensitivity and peripheral insulin-stimulated glucose disposal were reduced. These impairments were prevented in MCSFA-HFD, accompanied by increased basal fatty acid oxidation, maintained glucose metabolic flexibility, increased nonoxidative glucose disposal related to lower starting glycogen content, and increased glycogen synthase activity, together with increased muscle lactate production. In conclusion, substitution of a small amount of dietary LCFAs with MCFAs rescues insulin action in conditions of lipid-induced energy excess.",2021,"These impairments were prevented in MCSFA-HFD, accompanied by increased basal FA oxidation, maintained glucose metabolic flexibility, increased non-oxidative glucose disposal related to lower starting glycogen content and increased glycogen synthase activity, together with increased muscle lactate production.","['Healthy, lean men ingested a', 'humans', 'Humans']","['hyperinsulinemic-euglycemic clamp with femoral arteriovenous balance and glucose tracer', 'Medium-chain fatty acids (MCFAs', 'high-fat diet was enriched with saturated long-chain FAs (LCSFA-HFD), while the other group (n=9) ingested a matched diet, but with ∼30 g (5E%) saturated MCFAs (MCSFA-HFD', 'dietary MCFAs', 'Dietary Medium-Chain Fatty Acids Protect Against Insulin Resistance', 'eucaloric control diet and a three-day hypercaloric high-fat diet']","['basal FA oxidation, maintained glucose metabolic flexibility, increased non-oxidative glucose disposal', 'glycogen synthase activity', 'body insulin sensitivity and peripheral insulin-stimulated glucose disposal', 'muscle lactate production']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0450109', 'cui_str': 'Arteriovenous'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0522094', 'cui_str': 'Medium chain fatty acid'}, {'cui': 'C0521974', 'cui_str': 'High fat diet'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0017932', 'cui_str': 'Glycogen (starch) synthase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}]",,0.0199802,"These impairments were prevented in MCSFA-HFD, accompanied by increased basal FA oxidation, maintained glucose metabolic flexibility, increased non-oxidative glucose disposal related to lower starting glycogen content and increased glycogen synthase activity, together with increased muscle lactate production.","[{'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Lundsgaard', 'Affiliation': 'Section of Molecular Physiology, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Fritzen', 'Affiliation': 'Section of Molecular Physiology, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Sjøberg', 'Affiliation': 'Section of Molecular Physiology, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Kleinert', 'Affiliation': 'Section of Molecular Physiology, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Richter', 'Affiliation': 'Section of Molecular Physiology, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Kiens', 'Affiliation': 'Section of Molecular Physiology, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark bkiens@nexs.ku.dk.'}]",Diabetes,['10.2337/db20-0582'] 951,33126534,"The Metabolic Effects of Cynara Supplementation in Overweight and Obese Class I Subjects with Newly Detected Impaired Fasting Glycemia: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial.","Impaired fasting glucose (IFG) is a condition that precedes diabetes and increases the risk of developing it. Studies support the hypoglycemic effect of Cynara scolymus (Cs) extracts due to the content of chlorogenic acid, which is a potent inhibitor of glucose 6-phosphate translocase and of dicaffeoylquinic acid derivatives that modulate the activity of alpha-glucosidase. Given this background, we investigated whether a new highly standardized Cs extract could improve glycemic control, insulin sensitivity and other metabolic parameters (total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C) Triglycerides, Apolipo protein B (ApoB), Apolipo protein A (ApoA), waist circumference, visceral adipose tissue (VAT) by dual-energy X-ray absorptiometry (DXA) in overweight subjects with newly diagnosed IFG. Fifty-four subjects (females/males 26/28, mean ± SD age 51.5 ± 6.2) were randomly assigned to the supplemented group ( n = 27) and placebo ( n = 27). After multiple testing correction, statistically significant interactions between time and group were observed for the primary endpoint glycemia (β = 0.36, p < 0.0001) and for the secondary endpoints HDL (β = -0.10, p < 0.0001), total cholesterol/HDL (β = 0.27, p < 0.0001), LDL (β = 0.15, p = 0.005), LDL/HDL (β = 0.23, p = 0.001), insulin (β = 1.28, p = 0.04), glycated hemoglobin (β = 0.21, p = 0.0002), A1c-derived average glucose (β = 0.34, p = 0.0002), ApoB (β = 6.00, p = 0.01), ApoA (β = -4.50, p = 0.04), ApoB/ApoA (β = 0.08, p = 0.003), waist circumference (β = 1.89, p = 0.05), VATβ = 222.37, p = 0.005). In conclusion, these results confirm that Cs supplementation has a significant effect on metabolic parameters in IFG patients.",2020,"p = 0.04), glycated hemoglobin (β = 0.21, p = 0.0002), A1c-derived average glucose (β = 0.34, p = 0.0002), ApoB (β = 6.00, p = 0.01),","['Fifty-four subjects (females/males 26/28, mean ± SD age 51.5 ± 6.2', 'overweight subjects with newly diagnosed IFG', 'IFG patients', 'Overweight and Obese Class I Subjects with Newly Detected Impaired Fasting Glycemia']","['placebo', 'Placebo', 'Cynara Supplementation']","['total cholesterol/HDL', 'Impaired fasting glucose (IFG', 'waist circumference', 'primary endpoint glycemia', 'glycemic control, insulin sensitivity and other metabolic parameters (total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C) Triglycerides, Apolipo protein B (ApoB), Apolipo protein A (ApoA), waist circumference, visceral adipose tissue (VAT) by dual-energy X-ray absorptiometry (DXA', 'metabolic parameters', 'glycated hemoglobin']","[{'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1272092', 'cui_str': 'Impaired fasting glycaemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3853264', 'cui_str': 'Obese class I'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0771144', 'cui_str': 'Cynara Preparation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C1272092', 'cui_str': 'Impaired fasting glycaemia'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0377800', 'cui_str': 'protein B'}, {'cui': 'C0038164', 'cui_str': 'Protein A'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",54.0,0.147889,"p = 0.04), glycated hemoglobin (β = 0.21, p = 0.0002), A1c-derived average glucose (β = 0.34, p = 0.0002), ApoB (β = 6.00, p = 0.01),","[{'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Rondanelli', 'Affiliation': 'IRCCS Mondino Foundation, 27100 Pavia, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Riva', 'Affiliation': 'Research and Development Unit, Indena, 20139 Milan, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Petrangolini', 'Affiliation': 'Research and Development Unit, Indena, 20139 Milan, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Allegrini', 'Affiliation': 'Research and Development Unit, Indena, 20139 Milan, Italy.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Bernardinelli', 'Affiliation': 'Department of Brain and Behavioral Science, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Fazia', 'Affiliation': 'Department of Brain and Behavioral Science, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Peroni', 'Affiliation': 'Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ""Istituto Santa Margherita"", University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Gasparri', 'Affiliation': 'Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ""Istituto Santa Margherita"", University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Nichetti', 'Affiliation': 'Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ""Istituto Santa Margherita"", University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Milena Anna', 'Initials': 'MA', 'LastName': 'Faliva', 'Affiliation': 'Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ""Istituto Santa Margherita"", University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Naso', 'Affiliation': 'Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ""Istituto Santa Margherita"", University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Perna', 'Affiliation': 'Department of Biology, Sakhir Campus, College of Science, University of Bahrain, Sakheer P.O. Box 32038, Bahrain.'}]",Nutrients,['10.3390/nu12113298'] 952,33127585,"Prior Pain Exposure and Mere Possession of a Placebo Analgesic Predict Placebo Analgesia: Findings From a Randomized, Double-Blinded, Controlled Trial.","A recent study found that merely possessing a placebo analgesic reduces pain. The current study tested for a possible moderator of this effect. Specifically, does the mere possession of a placebo analgesic affect pain for individuals with and without immediate prior experience with the pain task? Healthy participants (N = 127) were randomized to prior pain (PP) condition or without prior pain (No-PP) condition. In the PP condition, participants first did a preliminary trial of a cold pressor test (CPT) to induce direct experience with this pain stimulus. Then they were randomized to possess an inert cream described as either an analgesic cream or an anti-itch cream (pain-irrelevant control object). Participants then completed the main CPT. In the No-PP condition, participants underwent identical procedures and randomization except that they did not do a preliminary CPT, thus having no immediate prior CPT pain experience. We found a significant prior pain experience and possession status interaction effect on placebo analgesia. Participants in the No-PP condition showed evidence of lower pain when they merely possessed an analgesic cream than an anti-itch cream. Such mere possession effect was not found in the PP condition. The impact of expectancy and emotion on the underlying process are discussed. PERSPECTIVE: This article presents a novel finding that prior pain exposure and mere possession of a placebo analgesic predicted placebo analgesia. It offers a novel perspective on the time course of placebo effect. It provides practical implications on potential pain intervention for clinicians and paradigm design for researchers of placebo study.",2021,Participants in the No-PP condition showed evidence of lower pain when they merely possessed an analgesic cream than an anti-itch cream.,['Healthy participants (N=127'],"['cold pressor test (CPT', 'placebo analgesic predicted placebo analgesia', 'prior pain (PP) condition or without prior pain (No-PP) condition', 'placebo analgesic', 'analgesic cream or an anti-itch cream (pain-irrelevant control object']","['lower pain', 'pain']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",127.0,0.337568,Participants in the No-PP condition showed evidence of lower pain when they merely possessed an analgesic cream than an anti-itch cream.,"[{'ForeName': 'Victoria Wai-Lan', 'Initials': 'VW', 'LastName': 'Yeung', 'Affiliation': 'Department of Applied Psychology, Lingnan University, Hong Kong. Electronic address: vickiyeung@ln.edu.hk.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Geers', 'Affiliation': 'Department of Psychology, University of Toledo, Toledo, Ohio.'}]",The journal of pain,['10.1016/j.jpain.2020.10.004'] 953,33130235,Effect of Intensive Urate Lowering With Combined Verinurad and Febuxostat on Albuminuria in Patients With Type 2 Diabetes: A Randomized Trial.,"RATIONALE & OBJECTIVE Hyperuricemia has been implicated in the development and progression of chronic kidney disease. Verinurad is a novel, potent, specific urate reabsorption inhibitor. We evaluated the effects on albuminuria of intensive urate-lowering therapy with verinurad combined with the xanthine oxidase inhibitor febuxostat in patients with hyperuricemia and type 2 diabetes mellitus (T2DM). STUDY DESIGN Phase 2, multicenter, prospective, randomized, double-blind, parallel-group, placebo-controlled trial. SETTING & PARTICIPANTS Patients 18 years or older with hyperuricemia, albuminuria, and T2DM. INTERVENTION Patients randomly assigned 1:1 to verinurad (9mg) plus febuxostat (80mg) or matched placebo once daily for 24 weeks. OUTCOMES The primary end point was change in urinary albumin-creatinine ratio (UACR) from baseline after 12 weeks' treatment. Secondary end points included safety and tolerability and effect on glomerular filtration. RESULTS 60 patients were enrolled (n=32, verinurad and febuxostat; n=28, placebo). UACRs after treatment with verinurad plus febuxostat were lower than after placebo at 1, 12, and 24 weeks: -38.6% (90% CI, -60.9% to-3.6%), -39.4% (90% CI, -61.8% to-3.8%), and-49.3% (90% CI, -68.2% to-19.0%), respectively. Serum urate levels after treatment with verinurad plus febuxostat were 59.6% and 63.7% lower than after placebo at 12 and 24 weeks, respectively. No clinically meaningful changes were observed in estimated glomerular filtration rate or serum creatinine or serum cystatin C concentrations. Verinurad plus febuxostat was well tolerated. LIMITATIONS Sample size and study duration were insufficient to evaluate definitive effects of verinurad plus febuxostat on UACR and glomerular filtration. Generalizability was limited by exclusion of patients with stages 4 and 5 chronic kidney disease. CONCLUSIONS Verinurad plus febuxostat reduced albuminuria and lowered serum urate concentrations in patients with T2DM, albuminuria, and hyperuricemia. Definitive assessment of their combined impact on preservation of kidney function awaits larger clinical studies. FUNDING This study was supported by AstraZeneca. TRIAL REGISTRATION Registered at ClinicalTrials.gov with study number NCT03118739.",2021,"No clinically meaningful changes were observed in estimated glomerular filtration rates (eGFR), serum creatinine, or serum cystatin C concentrations.","['60 patients were enrolled (n=32, verinurad and febuxostat; n=28', 'patients with T2DM, albuminuria, and hyperuricemia', 'Patients With Type 2 Diabetes', 'Patients aged ≥18 years with hyperuricemia, albuminuria, and T2DM', 'patients with hyperuricemia and type 2 diabetes mellitus (T2DM']","['febuxostat (80 mg) or matched placebo', 'placebo', 'Intensive Urate Lowering With Combined Verinurad and Febuxostat', 'intensive urate-lowering therapy with verinurad combined with the xanthine oxidase (XO) inhibitor febuxostat']","['Serum urate (sUA) levels', 'UACRs', 'safety and tolerability, and effect on kidney function', 'albuminuria and lowered sUA concentrations', 'tolerated', 'glomerular filtration rates (eGFR), serum creatinine, or serum cystatin C concentrations', 'change in urine albumin-to-creatinine ratio (UACR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4519235', 'cui_str': 'verinurad'}, {'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0740394', 'cui_str': 'Hyperuricemia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C4519235', 'cui_str': 'verinurad'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0043317', 'cui_str': 'Xanthine oxidase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042038', 'cui_str': 'Albumin urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",60.0,0.331098,"No clinically meaningful changes were observed in estimated glomerular filtration rates (eGFR), serum creatinine, or serum cystatin C concentrations.","[{'ForeName': 'Austin G', 'Initials': 'AG', 'LastName': 'Stack', 'Affiliation': 'Department of Nephrology, University Hospital Limerick & Health Research Institute, University of Limerick, Limerick, Ireland. Electronic address: austin.stack@ul.ie.'}, {'ForeName': 'Nalina', 'Initials': 'N', 'LastName': 'Dronamraju', 'Affiliation': 'AstraZeneca R&D, Gaithersburg, MD.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Parkinson', 'Affiliation': 'AstraZeneca R&D, Gothenburg, Sweden.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Johansson', 'Affiliation': 'AstraZeneca R&D, Gothenburg, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Johnsson', 'Affiliation': 'AstraZeneca R&D, Gothenburg, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Erlandsson', 'Affiliation': 'AstraZeneca R&D, Gothenburg, Sweden.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Terkeltaub', 'Affiliation': 'VAHCS and University of California, San Diego, CA.'}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2020.09.009'] 954,33131908,Dose-dependent reductions in plasma ceramides after anthocyanin supplementation are associated with improvements in plasma lipids and cholesterol efflux capacity in dyslipidemia: A randomized controlled trial.,"BACKGROUND & AIMS Plasma ceramides have been identified as novel risk factors for metabolic and cardiovascular diseases. We aimed to evaluate the effects of dietary anthocyanins on plasma ceramides and to disentangle whether the alterations in ceramides could be related with those in other cardiometabolic risk factors in the dyslipidemia. METHODS In a randomized double-blinded placebo-controlled trial, 176 eligible dyslipidemia subjects were randomly assigned into four groups receiving placebo, 40, 80, or 320 mg/day anthocyanins, respectively for 12 weeks. RESULTS A total of 169 subjects completed the study. After 12-week intervention, dietary anthocyanins dose-dependently reduced plasma concentrations of all six ceramide species in the dyslipidemia subjects (all P trend values < 0.05). Specifically, 320 mg/day anthocyanins effectively lowered plasma N-palmitoylsphingosine (Cer 16:0, mean change: -28.3 ± 41.2 versus 2.9 ± 38.2, nmol/L, P = 0.018) and N-tetracosanoylsphingosine (Cer 24:0, mean change: -157.1 ± 493.9 versus 10.7 ± 439.9, nmol/L, P = 0.002) compared with the placebo. The declines in plasma Cer 16:0 and Cer 24:0 were significantly correlated with the decreases in plasma non-high-density lipoprotein cholesterol (nonHDL-C, Spearman's r = 0.32, P = 0.040 for Cer 16:0; Spearman's r = 0.35, P = 0.026 for Cer 24:0), apolipoprotein B (Spearman's r = 0.33, P = 0.031 for Cer 16:0; Spearman's r = 0.48, P = 0.002 for Cer 24:0), and total cholesterol (Spearman's r = 0.34, P = 0.026 for Cer 16:0; Spearman's r = 0.31, P = 0.042 for Cer 24:0) after 12-week 320 mg/day anthocyanin administration. Besides, we found that anthocyanins at 320 mg/day also markedly enhanced cholesterol efflux capacity in the dyslipidemia, the changes of which were positively associated with the reductions in Cer 16:0 (Spearman's r = 0.42, P = 0.006) independent of HDL-C and apolipoprotein A-I. CONCLUSIONS Reductions in plasma Cer 16:0 and Cer 18:0 after 12-week anthocyanin intervention were dose-dependently associated with improvements in plasma lipids and cholesterol efflux capacity in the dyslipidemia. CLINICAL TRIAL REGISTRATION The study was registered at ClinicalTrials.gov with the identifier No. NCT03415503.",2021,"After 12-week intervention, dietary anthocyanins dose-dependently reduced plasma concentrations of all six ceramide species in the dyslipidemia subjects (all P trend values < 0.05).","['169 subjects completed the study', '176 eligible dyslipidemia subjects']","['anthocyanins', 'anthocyanin supplementation', 'placebo', 'dietary anthocyanins']","['plasma lipids and cholesterol efflux capacity', 'total cholesterol', 'plasma concentrations', 'plasma non-high-density lipoprotein cholesterol', 'plasma lipids and cholesterol efflux capacity in dyslipidemia', 'plasma N-palmitoylsphingosine', 'apolipoprotein B', 'cholesterol efflux capacity', 'plasma Cer']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}]","[{'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0386062', 'cui_str': 'N-palmitoylsphingosine'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0237504', 'cui_str': 'CER'}]",176.0,0.200688,"After 12-week intervention, dietary anthocyanins dose-dependently reduced plasma concentrations of all six ceramide species in the dyslipidemia subjects (all P trend values < 0.05).","[{'ForeName': 'Yimin', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'School of Public Health (Shenzhen), Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Provincial Key Laboratory of Food, Nutrition, and Health, Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Engineering Technology Center of Nutrition Transformation, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Huihui', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition, and Health, Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Engineering Technology Center of Nutrition Transformation, Sun Yat-sen University, Guangzhou, Guangdong, China; Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Zezhong', 'Initials': 'Z', 'LastName': 'Tian', 'Affiliation': 'School of Public Health (Shenzhen), Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Provincial Key Laboratory of Food, Nutrition, and Health, Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Engineering Technology Center of Nutrition Transformation, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition, and Health, Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Engineering Technology Center of Nutrition Transformation, Sun Yat-sen University, Guangzhou, Guangdong, China; Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'School of Public Health (Shenzhen), Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Provincial Key Laboratory of Food, Nutrition, and Health, Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Engineering Technology Center of Nutrition Transformation, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Kongyao', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'School of Public Health (Shenzhen), Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Provincial Key Laboratory of Food, Nutrition, and Health, Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Engineering Technology Center of Nutrition Transformation, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'School of Public Health (Shenzhen), Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Provincial Key Laboratory of Food, Nutrition, and Health, Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Engineering Technology Center of Nutrition Transformation, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Die', 'Initials': 'D', 'LastName': 'Fan', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition, and Health, Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Engineering Technology Center of Nutrition Transformation, Sun Yat-sen University, Guangzhou, Guangdong, China; Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xilin', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'School of Public Health (Shenzhen), Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Provincial Key Laboratory of Food, Nutrition, and Health, Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Engineering Technology Center of Nutrition Transformation, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Ling', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition, and Health, Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Engineering Technology Center of Nutrition Transformation, Sun Yat-sen University, Guangzhou, Guangdong, China; Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'School of Public Health (Shenzhen), Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Provincial Key Laboratory of Food, Nutrition, and Health, Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Engineering Technology Center of Nutrition Transformation, Sun Yat-sen University, Guangzhou, Guangdong, China. Electronic address: yangyan3@mail.sysu.edu.cn.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.10.014'] 955,33131909,The effect of a duodenal-jejunal bypass liner on lipid profile and blood concentrations of long chain polyunsaturated fatty acids.,"BACKGROUND & AIMS Duodenal-jejunal bypass liners (DJBLs) prevent absorption in the proximal small intestine, the site of fatty acid absorption. We sought to investigate the effects of a DJBL on blood concentrations of essential fatty acids (EFAs) and bioactive polyunsaturated fatty acids (PUFAs). METHODS Sub-study of a multicentre, randomised, controlled trial with two treatment groups. Patients aged 18-65 years with type-2 diabetes mellitus and body mass index 30-50 kg/m 2 were randomised to receive a DJBL for 12 months or best medical therapy, diet and exercise. Whole plasma PUFA concentrations were determined at baseline, 10 days, 6 and 11.5 months; data were available for n = 70 patients per group. RESULTS Weight loss was significantly greater in the DJBL group compared to controls after 11.5 months: total body weight loss 11.3 ± 5.3% versus 6.0 ± 5.7% (mean difference [95% CI] = 5.27% [3.75, 6.80], p < 0.001). Absolute concentrations of both EFAs, linoleic acid and α-linolenic acid, and their bioactive derivatives, arachidonic acid, eicosapentaenoic acid, docosapentaenoic acid and docosahexaenoic acid, were significantly lower in the DJBL group than in the control group at 6 and 11.5 months follow-up. Total serum cholesterol, LDL-cholesterol and HDL-cholesterol were also significantly lower in the DJBL group. CONCLUSION One year of DJBL therapy is associated with superior weight loss and greater reductions in total serum cholesterol and LDL-cholesterol, but also depletion of EFAs and their longer chain derivatives. DJBL therapy may need to be offset by maintaining an adequate dietary intake of PUFAs or by supplementation. TRIAL REGISTRATION ClinicalTrials.gov Identifier NCT02459561.",2021,"One year of DJBL therapy is associated with superior weight loss and greater reductions in total serum cholesterol and LDL-cholesterol, but also depletion of EFAs and their longer chain derivatives.","['70 patients per group', 'Patients aged 18-65 years with type-2 diabetes mellitus and body mass index 30-50\xa0kg/m 2']","['DJBL', 'DJBL for 12 months or best medical therapy, diet and exercise', 'Duodenal-jejunal bypass liners (DJBLs', 'duodenal-jejunal bypass liner']","['total serum cholesterol and LDL-cholesterol', 'total body weight loss', 'Total serum cholesterol, LDL-cholesterol and HDL-cholesterol', 'Whole plasma PUFA concentrations', 'superior weight loss', 'blood concentrations of essential fatty acids (EFAs) and bioactive polyunsaturated fatty acids (PUFAs', 'Absolute concentrations of both EFAs, linoleic acid and α-linolenic acid, and their bioactive derivatives, arachidonic acid, eicosapentaenoic acid, docosapentaenoic acid and docosahexaenoic acid', 'Weight loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3880361', 'cui_str': 'Duodenal-jejunal bypass liner'}]","[{'cui': 'C1445957', 'cui_str': 'Serum total cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated fatty acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0427728', 'cui_str': 'Blood concentration, dipstick - finding'}, {'cui': 'C0015686', 'cui_str': 'Fatty Acids, Essential'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0023749', 'cui_str': 'Linoleic acid'}, {'cui': 'C0051405', 'cui_str': 'alpha-Linolenic Acid'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0058624', 'cui_str': 'docosapentaenoic acid'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}]",,0.104392,"One year of DJBL therapy is associated with superior weight loss and greater reductions in total serum cholesterol and LDL-cholesterol, but also depletion of EFAs and their longer chain derivatives.","[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Glaysher', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, UK. Electronic address: michaelglaysher@me.com.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Ward', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Madhawi', 'Initials': 'M', 'LastName': 'Aldhwayan', 'Affiliation': 'Imperial College London, London, UK; Department of Community Health Sciences, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Aruchuna', 'Initials': 'A', 'LastName': 'Ruban', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'Christina Gabriele', 'Initials': 'CG', 'LastName': 'Prechtl', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'Helena L', 'Initials': 'HL', 'LastName': 'Fisk', 'Affiliation': 'School of Human Development & Health, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Navpreet', 'Initials': 'N', 'LastName': 'Chhina', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'Werd', 'Initials': 'W', 'LastName': 'Al-Najim', 'Affiliation': 'Imperial College London, London, UK; Diabetes Complications Research Centre, Conway Institute, School of Medicine and Medical Sciences, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Smith', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Klimowska-Nassar', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Johnson', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'Emmanuela', 'Initials': 'E', 'LastName': 'Falaschetti', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Goldstone', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'Alexander Dimitri', 'Initials': 'AD', 'LastName': 'Miras', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Byrne', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Calder', 'Affiliation': 'School of Human Development & Health, Faculty of Medicine, University of Southampton, Southampton, UK; NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton, UK.'}, {'ForeName': 'Julian P', 'Initials': 'JP', 'LastName': 'Teare', 'Affiliation': 'Imperial College London, London, UK.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.10.026'] 956,33138210,Impact on Dietary Intake of Two Levels of Technology-Assisted Personalized Nutrition: A Randomized Trial.,"Advances in web and mobile technologies have created efficiencies relating to collection, analysis and interpretation of dietary intake data. This study compared the impact of two levels of nutrition support: (1) low personalization, comprising a web-based personalized nutrition feedback report generated using the Australian Eating Survey ® (AES) food frequency questionnaire data; and (2) high personalization, involving structured video calls with a dietitian using the AES report plus dietary self-monitoring with text message feedback. Intake was measured at baseline and 12 weeks using the AES and diet quality using the Australian Recommended Food Score (ARFS). Fifty participants (aged 39.2 ± 12.5 years; Body Mass Index 26.4 ± 6.0 kg/m 2 ; 86.0% female) completed baseline measures. Significant ( p < 0.05) between-group differences in dietary changes favored the high personalization group for total ARFS (5.6 points (95% CI 1.3 to 10.0)) and ARFS sub-scales of meat (0.9 points (0.4 to 1.6)), vegetarian alternatives (0.8 points (0.1 to 1.4)), and dairy (1.3 points (0.3 to 2.3)). Additional significant changes in favor of the high personalization group occurred for proportion of energy intake derived from energy-dense, nutrient-poor foods (-7.2% (-13.8% to -0.5%)) and takeaway foods sub-group (-3.4% (-6.5% to 0.3%). Significant within-group changes were observed for 12 dietary variables in the high personalization group vs one variable for low personalization. A higher level of personalized support combining the AES report with one-on-one dietitian video calls and dietary self-monitoring resulted in greater dietary change compared to the AES report alone. These findings suggest nutrition-related web and mobile technologies in combination with personalized dietitian delivered advice have a greater impact compared to when used alone.",2020,"Significant ( p < 0.05) between-group differences in dietary changes favored the high personalization group for total ARFS (5.6 points (95% CI 1.3 to 10.0)) and ARFS sub-scales of meat (0.9 points (0.4 to 1.6)), vegetarian alternatives (0.8 points (0.1 to 1.4)), and dairy (1.3 points (0.3 to 2.3)).",['Fifty participants (aged 39.2\u2009±\u200912.5 years; Body Mass Index 26.4\u2009±\u20096.0 kg/m 2 ; 86.0% female'],"['nutrition support: (1) low personalization, comprising a web-based personalized nutrition feedback report generated using the Australian Eating Survey ® (AES) food frequency questionnaire data; and (2) high personalization, involving structured video calls with a dietitian using the AES report plus dietary self-monitoring with text message feedback', 'Technology-Assisted Personalized Nutrition']","['ARFS sub-scales of meat', 'proportion of energy intake', 'total ARFS', 'dietary changes']","[{'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0242739', 'cui_str': 'Nutritional support'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0882079,"Significant ( p < 0.05) between-group differences in dietary changes favored the high personalization group for total ARFS (5.6 points (95% CI 1.3 to 10.0)) and ARFS sub-scales of meat (0.9 points (0.4 to 1.6)), vegetarian alternatives (0.8 points (0.1 to 1.4)), and dairy (1.3 points (0.3 to 2.3)).","[{'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Rollo', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, The University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Haslam', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, The University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Clare E', 'Initials': 'CE', 'LastName': 'Collins', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, The University of Newcastle, Callaghan, NSW 2308, Australia.'}]",Nutrients,['10.3390/nu12113334'] 957,33141099,Effect of a Text Messaging-Based Educational Intervention on Cesarean Section Rates Among Pregnant Women in China: Quasirandomized Controlled Trial.,"BACKGROUND Consensus exists that appropriate regional cesarean rates should not exceed 15% of births, but China's cesarean rate exceeds 50% in some areas, prompting numerous calls for its reduction. At present, China's 2016 two-child policy has heightened the implications of national cesarean section trends. OBJECTIVE This study leveraged pervasive cellular phone access amongst Chinese citizens to test the effect of a low-cost and scalable prenatal advice program on cesarean section rates. METHODS Participants were pregnant women presenting for antenatal care at a clinic in Xi'an, China. Assignment was quasirandomized and utilized factorial assignment based on the expecting mother's birthday. Participants were assigned to one of the following four groups, with each receiving a different set of messages: (1) a comparison group that received only a few ""basic"" messages, (2) a group receiving messages primarily regarding care seeking, (3) a group receiving messages primarily regarding good home prenatal practices, and (4) a group receiving text messages of all groups. Messages were delivered throughout pregnancy and were tailored to each woman's gestational week. The main outcome was the rates of cesarean delivery reported in the intervention arms. Data analysts were blinded to treatment assignment. RESULTS In total, 2115 women completed the trial and corresponding follow-up surveys. In the unadjusted analysis, the group receiving all texts was associated with an odds ratio of 0.77 (P=.06), though neither the care seeking nor good home prenatal practice set yielded a relevant impact. Adjusting for potentially confounding covariates showed that the group with all texts sent together was associated with an odds ratio of 0.67 (P=.01). Notably, previous cesarean section evoked an odds ratio of 11.78 (P<.001), highlighting that having a cesarean section predicts future cesarean section in a subsequent pregnancy. CONCLUSIONS Sending pregnant women in rural China short informational messages with integrated advice regarding both care-seeking and good home prenatal practices appears to reduce women's likelihood of undergoing cesarean section. Reducing clear medical indications for cesarean section seems to be the strongest potential pathway of the effect. Cesarean section based on only maternal request did not seem to occur regularly in our study population. Preventing unnecessary cesarean section at present may have a long-term impact on future cesarean section rates. TRIAL REGISTRATION ClinicalTrials.gov NCT02037087; https://clinicaltrials.gov/ct2/show/NCT02037087. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) RR2-10.1136/bmjopen-2015-011016.",2020,"In the unadjusted analysis, the group receiving all texts was associated with an odds ratio of 0.77 (P=.06), though neither the care seeking nor good home prenatal practice set yielded a relevant impact.","['Pregnant Women in China', ""Participants were pregnant women presenting for antenatal care at a clinic in Xi'an, China"", '2115 women completed the trial and corresponding follow-up surveys', 'Sending pregnant women in rural']","['Text Messaging-Based Educational Intervention', 'low-cost and scalable prenatal advice program', 'China short informational messages with integrated advice regarding both care-seeking and good home prenatal practices', 'comparison group that received only a few ""basic"" messages, (2) a group receiving messages primarily regarding care seeking, (3) a group receiving messages primarily regarding good home prenatal practices, and (4) a group receiving text messages of all groups']","['rates of cesarean delivery', 'Cesarean Section Rates', 'cesarean section rates']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0007876', 'cui_str': 'Cesarean section'}]",2115.0,0.0904687,"In the unadjusted analysis, the group receiving all texts was associated with an odds ratio of 0.77 (P=.06), though neither the care seeking nor good home prenatal practice set yielded a relevant impact.","[{'ForeName': 'Yanfang', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': 'School of Medicine, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Heitner', 'Affiliation': 'Aceso Global, Washington, DC, United States.'}, {'ForeName': 'Changzheng', 'Initials': 'C', 'LastName': 'Yuan', 'Affiliation': ""The Children's Hospital and School of Public Health, Zhejiang University School of Medicine, Hangzhou, China.""}, {'ForeName': 'Yafei', 'Initials': 'Y', 'LastName': 'Si', 'Affiliation': 'School of Risk & Actuarial Studies and Centre of Excellence in Population Ageing Research (CEPAR), University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': ""School of Public Policy and Administration, Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': ""School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, China.""}, {'ForeName': 'Zhongliang', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': ""School of Public Policy and Administration, Xi'an Jiaotong University, Xi'an, China.""}]",JMIR mHealth and uHealth,['10.2196/19953'] 958,33142016,"Effect of Nintedanib on Lung Function in Patients With Systemic Sclerosis-Associated Interstitial Lung Disease: Further Analyses of a Randomized, Double-Blind, Placebo-Controlled Trial.","OBJECTIVE In the SENSCIS trial in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD), nintedanib reduced the rate of decline in forced vital capacity (FVC) over 52 weeks by 44% versus placebo. This study was undertaken to investigate the effects of nintedanib on categorical changes in FVC and other measures of ILD progression. METHODS In post hoc analyses, we assessed the proportions of subjects with categorical changes in FVC % predicted at week 52 and the time to absolute decline in FVC of ≥5% predicted or death and absolute decline in FVC of ≥10% predicted or death. RESULTS A total of 288 subjects received nintedanib and 288 subjects received placebo. At week 52, in subjects treated with nintedanib and placebo, respectively, 55.7% and 66.3% had any decline in FVC % predicted, 13.6% and 20.1% had a decline in FVC of >5% to ≤10% predicted, and 3.5% and 5.2% had a decline in FVC of >10% to ≤15% predicted; 34.5% and 43.8% had a decrease in FVC of ≥3.3% predicted (proposed minimal clinically important difference [MCID] for worsening of FVC), while 23.0% and 14.9% had an increase in FVC of ≥3.0% predicted (proposed MCID for improvement in FVC). Over 52 weeks, the hazard ratio (HR) for an absolute decline in FVC of ≥5% predicted or death with nintedanib versus placebo was 0.83 (95% confidence interval [95% CI] 0.66-1.06) (P = 0.14), and the HR for an absolute decline in FVC of ≥10% predicted was 0.64 (95% CI 0.43-0.95) (P = 0.029). CONCLUSION These results suggest that nintedanib has a clinically relevant benefit on the progression of SSc-ILD.",2021,"Over 52 weeks, the hazard ratio for an absolute decline in FVC ≥5% predicted or death with nintedanib versus placebo was 0.83 (95% CI: 0.66, 1.06) (P=0.14) and the hazard ratio for an absolute decline in FVC ≥10% predicted was 0.64 (95% CI: 0.43, 0.95); P=0.029. ","['subjects with systemic sclerosis-associated ILD (SSc-ILD', 'patients with systemic sclerosis-associated interstitial lung disease', '288 subjects received nintedanib and 288 received']","['nintedanib and placebo', 'placebo', 'nintedanib']","['lung function', 'FVC decline']","[{'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0036429', 'cui_str': 'Sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2930789', 'cui_str': 'nintedanib'}]","[{'cui': 'C2930789', 'cui_str': 'nintedanib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}]",288.0,0.283625,"Over 52 weeks, the hazard ratio for an absolute decline in FVC ≥5% predicted or death with nintedanib versus placebo was 0.83 (95% CI: 0.66, 1.06) (P=0.14) and the hazard ratio for an absolute decline in FVC ≥10% predicted was 0.64 (95% CI: 0.43, 0.95); P=0.029. ","[{'ForeName': 'Toby M', 'Initials': 'TM', 'LastName': 'Maher', 'Affiliation': 'National Heart and Lung Institute, Imperial College London and NIHR Clinical Research Facility, Royal Brompton Hospital, London, UK, and Keck School of Medicine, University of Southern California, Los Angeles.'}, {'ForeName': 'Maureen D', 'Initials': 'MD', 'LastName': 'Mayes', 'Affiliation': 'University of Texas McGovern Medical School, Houston.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kreuter', 'Affiliation': 'Thoraxklinik, University of Heidelberg, and the German Center for Lung Research, Heidelberg, Germany.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Volkmann', 'Affiliation': 'University of California, David Geffen School of Medicine, Los Angeles.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Aringer', 'Affiliation': 'University Medical Center and Faculty of Medicine Carl Gustav Carus, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Castellvi', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Cutolo', 'Affiliation': 'University of Genova, IRCCS San Martino Polyclinic Hospital, Genova, Italy.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Stock', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Schoof', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Margarida', 'Initials': 'M', 'LastName': 'Alves', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Raghu', 'Affiliation': 'University of Washington, Seattle.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41576'] 959,33159523,Phase-locked auditory stimulation of theta oscillations during rapid eye movement sleep.,"Auditory closed-loop stimulation is a non-invasive technique that has been widely used to augment slow oscillations during non-rapid eye movement sleep. Based on the principles of closed-loop stimulation, we developed a novel protocol for manipulating theta activity (3-7 Hz) in rapid eye movement (REM) sleep. Sixteen healthy young adults were studied in two overnight conditions: Stimulation and Sham. In the Stimulation condition, 1 s of 5 Hz amplitude-modulated white noise was delivered upon detection of two supra-threshold theta cycles throughout REM sleep. In the Sham condition, corresponding time points were marked but no stimulation was delivered. Auditory stimulation entrained EEG activity to 5 Hz and evoked a brief (~0.5 s) increase in theta power. Interestingly, this initial theta surge was immediately followed by a prolonged (~3 s) period of theta suppression. Stimulation also induced a prolonged (~2 s) increase in beta power. Our results provide the first demonstration that the REM sleep theta rhythm can be manipulated in a targeted manner via auditory stimulation. Accordingly, auditory stimulation might offer a fruitful avenue for investigating REM sleep electrophysiology and its relationship to behavior.",2021,Auditory stimulation entrained EEG activity to 5 Hz and evoked a brief (~0.5 s) increase in theta power.,['Sixteen healthy young adults'],['Auditory closed-loop stimulation'],['beta power'],"[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0330390', 'cui_str': 'Beta'}]",16.0,0.0496906,Auditory stimulation entrained EEG activity to 5 Hz and evoked a brief (~0.5 s) increase in theta power.,"[{'ForeName': 'Marcus O', 'Initials': 'MO', 'LastName': 'Harrington', 'Affiliation': 'Department of Psychology, University of York, Heslington, York, UK.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Ashton', 'Affiliation': 'Department of Psychology, University of York, Heslington, York, UK.'}, {'ForeName': 'Hong-Viet V', 'Initials': 'HV', 'LastName': 'Ngo', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Radboudumc, The Netherlands.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Cairney', 'Affiliation': 'Department of Psychology, University of York, Heslington, York, UK.'}]",Sleep,['10.1093/sleep/zsaa227'] 960,33114392,Vitamin D Supplementation during Winter: Effects on Stress Resilience in a Randomized Control Trial.,"Vitamin D status may be important for stress resilience. This study investigated the effects of vitamin D supplements during winter on biological markers of stress resilience such as psychophysiological activity, serotonin, and cortisol in a placebo-controlled, randomized clinical trial. Eighty-six participants were randomly assigned to the Intervention (vitamin D) or Control (placebo) groups. Before and after the intervention participants were exposed to an experimental stress procedure. Psychophysiological activity was measured during three main conditions: baseline, stress, and recovery. Fasting blood samples were taken in the morning and saliva samples were collected at seven different time points across 24 h. Prior to intervention both groups had normal/sufficient vitamin D levels. Both groups showed a normal pattern of psychophysiological responses to the experimental stress procedure (i.e., increased psychophysiological responses from resting baseline to stress-condition, and decreased psychophysiological responses from stress-condition to recovery; all p < 0.009). Post-intervention, the Intervention group showed increased vitamin D levels ( p < 0.001) and normal psychophysiological responses to the experimental stress procedure ( p < 0.001). Importantly, the Control group demonstrated a classic nadir in vitamin D status post-intervention (spring) ( p < 0.001) and did not show normal psychophysiological responses. Thus, physiologically the Control group showed a sustained stress response. No significant effects of vitamin D were found on serotonin and cortisol.",2020,"Post-intervention, the Intervention group showed increased vitamin D levels ( p < 0.001) and normal psychophysiological responses to the experimental stress procedure ( p < 0.001).",['Eighty-six participants'],"['vitamin D supplements', 'Intervention (vitamin D) or Control (placebo', 'Vitamin D Supplementation']","['normal psychophysiological responses', 'Psychophysiological activity', 'vitamin D', 'classic nadir in vitamin D status', 'sustained stress response', 'Fasting blood samples', 'serotonin and cortisol', 'normal pattern of psychophysiological responses', 'vitamin D levels', 'psychophysiological responses']","[{'cui': 'C3816958', 'cui_str': '80'}]","[{'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",86.0,0.0423443,"Post-intervention, the Intervention group showed increased vitamin D levels ( p < 0.001) and normal psychophysiological responses to the experimental stress procedure ( p < 0.001).","[{'ForeName': 'Anita L', 'Initials': 'AL', 'LastName': 'Hansen', 'Affiliation': 'Department of Psychosocial Science, University of Bergen, Christiesgt. 12, 5015 Bergen, Norway.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Ambroziak', 'Affiliation': 'Sand Ridge Secure Treatment Center (SRSTC), P.O. Box 0700, 1111 North Road, Mauston, WI 53948, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thornton', 'Affiliation': 'Sand Ridge Secure Treatment Center (SRSTC), P.O. Box 0700, 1111 North Road, Mauston, WI 53948, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Mundt', 'Affiliation': 'Sand Ridge Secure Treatment Center (SRSTC), P.O. Box 0700, 1111 North Road, Mauston, WI 53948, USA.'}, {'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Kahn', 'Affiliation': 'Sand Ridge Secure Treatment Center (SRSTC), P.O. Box 0700, 1111 North Road, Mauston, WI 53948, USA.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Dahl', 'Affiliation': 'Department of Seafood, Nutrition and Environmental State, Institute of Marine Research, P.O. Box 1870, Nordnes, 5817 Bergen, Norway.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Waage', 'Affiliation': 'Centre for Research and Education in Forensic Psychiatry, Haukeland University Hospital, 5021 Bergen, Norway.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Kattenbraker', 'Affiliation': 'Sand Ridge Secure Treatment Center (SRSTC), P.O. Box 0700, 1111 North Road, Mauston, WI 53948, USA.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Araujo', 'Affiliation': 'Department of Seafood, Nutrition and Environmental State, Institute of Marine Research, P.O. Box 1870, Nordnes, 5817 Bergen, Norway.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Murison', 'Affiliation': 'Department of Biological and Medical Psychology, University of Bergen, Jonas Lies vei 91, 5021 Bergen, Norway.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Rypdal', 'Affiliation': 'Centre for Research and Education in Forensic Psychiatry, Haukeland University Hospital, 5021 Bergen, Norway.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Grung', 'Affiliation': 'Department of Chemistry, University of Bergen, Allégaten 41, 5007 Bergen, Norway.'}]",Nutrients,['10.3390/nu12113258'] 961,33115598,"The effect of dietary nitrate and vitamin C on endothelial function, oxidative stress and blood lipids in untreated hypercholesterolemic subjects: A randomized double-blind crossover study.","BACKGROUND Vitamin C may enhance nitric oxide (NO) production through stepwise reduction of dietary nitrate (NO 3 ) to nitrite (NO 2 ) to NO. The combined effect of vitamin C and NO 3 supplementation is relatively unexplored in untreated hypercholesterolemia. AIMS We aimed to examine whether co-administration of vitamin C and nitrate for 4-weeks would improve endothelial function (primary outcome), plasma NO metabolites, oxidative stress, and blood lipids (secondary outcomes). METHODS Subjects 50-70 years of age with low density lipoprotein (LDL) > 130 mg/dL and RHI ≤2 were enrolled in this randomized double-blind crossover study. Subjects were assigned to two 4-week supplementation treatments starting with 70 ml of concentrated beetroot juice (CBJ) with 1000 mg of vitamin C (NC) or CBJ with matched placebo (N), then switched to alternate treatment following 2-week washout. The change in reactive hyperemia index (RHI), sum of plasma NO metabolites (NO 2  + NO 3 (NOx)), oxidized LDL (oxLDL), and serum lipids were assessed at baseline and at 4-weeks of each treatment period. RESULTS Eighteen subjects (11M:7F) completed all study visits. No significant treatment differences were observed in RHI change (N: 0.21 ± 0.12; NC: 0.20 ± 0.17; p = 0.99). Secondary analysis revealed that a subgroup of NC subjects who started with a baseline RHI of <1.67 (threshold value for ED) had greater improvements in RHI compared to subjects with RHI >1.67 (1.23 ± 0.15 to 1.96 ± 0.19; n = 8 vs. 1.75 ± 0.11 to 1.43 ± 0.10; n = 8; p = 0.02). Compared to N, NC experienced a significant increase in plasma NOx (N: 94.2 ± 15.5 μmol/L; NC: 128.7 ± 29.1 μmol/L; p = 0.01). Although there was no significant difference in oxLDL change between treatments (N: -1.08 ± 9.8 U/L; NC: -6.07 ± 9.14 U/L; p = 0.19), NC elicited significant reductions in LDL (N: 2.2 ± 2; NC: -10.7 ± 23; p = 0.049), triglycerides (N: 14.6 ± 43; NC: -43.7 ± 45; p = 0.03), and no change in serum high density lipoprotein. Within treatment group comparisons showed that only NC reduced oxLDL significantly from baseline to 4 weeks (p = 0.01). CONCLUSIONS No between intervention differences were observed in RHI. RHI only improved in NC subjects with ED at intervention baseline. Four weeks of NC enriched the NO pool and promoted reduction of blood lipids and oxidative stress in subjects with hypercholesterolemia. These preliminary findings highlight a supplementation strategy that may reduce the progression of atherosclerotic disease and deserves further attention in studies using flow mediated dilation methods. CLINICAL TRIAL REGISTRATION www.clinicaltrials.gov (NCT04283630).",2021,"Within treatment group comparisons showed that only NC reduced oxLDL significantly from baseline to 4 weeks (p = 0.01). ","['Subjects 50-70 years of age with low density lipoprotein (LDL)\xa0', '130', 'untreated hypercholesterolemic subjects', 'subjects with hypercholesterolemia', 'Eighteen subjects (11M:7F) completed all study visits']","['vitamin C and NO 3 supplementation', 'vitamin C and nitrate', 'supplementation treatments starting with 70\xa0ml of concentrated beetroot juice (CBJ) with 1000\xa0mg of vitamin C (NC) or CBJ with matched placebo', 'dietary nitrate and vitamin C']","['NO 3 (NOx)), oxidized LDL (oxLDL), and serum lipids', 'endothelial function (primary outcome), plasma NO metabolites, oxidative stress, and blood lipids (secondary outcomes', 'reactive hyperemia index (RHI), sum of plasma', 'plasma NOx', 'RHI', 'RHI change', 'oxLDL change', 'endothelial function, oxidative stress and blood lipids', 'serum high density lipoprotein', 'blood lipids and oxidative stress', 'NC reduced oxLDL']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",,0.517327,"Within treatment group comparisons showed that only NC reduced oxLDL significantly from baseline to 4 weeks (p = 0.01). ","[{'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Basaqr', 'Affiliation': 'Department of Pharmacology and Nutritional Sciences, College of Medicine, University of Kentucky, USA. Electronic address: reem.basaqr@uky.edu.'}, {'ForeName': 'Michealia', 'Initials': 'M', 'LastName': 'Skleres', 'Affiliation': 'Department of Pharmacology and Nutritional Sciences, College of Medicine, University of Kentucky, USA. Electronic address: michealia.skleres@uky.edu.'}, {'ForeName': 'Rani', 'Initials': 'R', 'LastName': 'Jayswal', 'Affiliation': 'Department of Biostatistics & Bioinformatics, University of Kentucky, USA. Electronic address: rani.jayswal@uky.edu.'}, {'ForeName': 'D Travis', 'Initials': 'DT', 'LastName': 'Thomas', 'Affiliation': 'Department of Athletic Training and Clinical Nutrition, College of Health Sciences, University of Kentucky, USA. Electronic address: dth225@uky.edu.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.10.012'] 962,33120238,Classification of renal tumour using convolutional neural networks to detect oncocytoma.,"PURPOSE To investigate the ability of convolutional neural networks (CNNs) to facilitate differentiation of oncocytoma from renal cell carcinoma (RCC) using non-invasive imaging technology. METHODS Data were collected from 369 patients between January 2015 and September 2018. True labelling of scans as benign or malignant was determined by subsequent histological findings post-surgery or ultrasound-guided percutaneous biopsy. The data included 20,000 2D CT images. Data were randomly divided into sets for training (70 %), validation (10 %) and independent testing (20 %, DataTest_1). A small dataset (DataTest_2) was used for additional validation of the training model. Data were divided into sets at the patient level, rather than by individual image. A modified version of the ResNet50V2 was used. Accuracy of detecting benign or malignant renal mass was evaluated by a 51 % majority vote of individual image classifications to determine the classification for each patient. RESULTS Test results from DataTest_1 indicate an area under the curve (AUC) of 0.973 with 93.3 % accuracy and 93.5 % specificity. Results from DataTest_2 indicate an AUC of 0.946 with 90.0 % accuracy and 98.0 % specificity when evaluation is performed image by image. There is no case in which multiple false negative images originate from the same patient. When evaluated with 51 % majority of scans for each patient, the accuracy rises to 100 % and the incidence of false negatives falls to zero. CONCLUSION CNNs and deep learning technology can classify renal tumour masses as oncocytoma with high accuracy. This diagnostic method could prevent overtreatment for patients with renal masses.",2020,True labelling of scans as benign or malignant was determined by subsequent histological findings post-surgery or ultrasound-guided percutaneous biopsy.,"['Data were collected from 369 patients between January 2015 and September 2018', 'patients with renal masses']","['convolutional neural networks (CNNs', 'CNNs and deep learning technology']","['Accuracy of detecting benign or malignant renal mass', 'accuracy rises', 'area under the curve (AUC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262613', 'cui_str': 'Renal mass'}]","[{'cui': 'C0242406', 'cui_str': 'Neural Networks (Anatomic)'}, {'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0262613', 'cui_str': 'Renal mass'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",369.0,0.020162,True labelling of scans as benign or malignant was determined by subsequent histological findings post-surgery or ultrasound-guided percutaneous biopsy.,"[{'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Pedersen', 'Affiliation': 'Department of People and Technology (DPT), Roskilde University Universitetsvej 1, 4000, Roskilde, Denmark. Electronic address: mikkped@ruc.dk.'}, {'ForeName': 'Michael Brun', 'Initials': 'MB', 'LastName': 'Andersen', 'Affiliation': 'Department of Radiology, Herlev-Gentofte University Hospital, Herlev Ringvej 75, 2700, Herlev, Denmark. Electronic address: michael.brun.andersen@regionh.dk.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Christiansen', 'Affiliation': 'Department of People and Technology (DPT), Roskilde University Universitetsvej 1, 4000, Roskilde, Denmark. Electronic address: henning@ruc.dk.'}, {'ForeName': 'Nessn H', 'Initials': 'NH', 'LastName': 'Azawi', 'Affiliation': 'Department of Urology, Zealand University Hospital, Roskilde, Department of Clinical Medicine, Copenhagen University, Sygehusvej 10, 4000, Roskilde, Denmark. Electronic address: nesa@regionsjaelland.dk.'}]",European journal of radiology,['10.1016/j.ejrad.2020.109343'] 963,33122573,Dexmedetomidine versus midazolam for sedation during endobronchial ultrasound-guided transbronchial needle aspiration: A randomised controlled trial.,"BACKGROUND Desaturation is a common complication of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). Dexmedetomidine (DEX), a commonly used sedative in intensive care, is associated with less respiratory depression compared with other sedatives. OBJECTIVE We compared DEX with midazolam (MDZ) when used as a sedative during EBUS-TBNA. DESIGN A randomised, parallel, double-blinded trial. SETTING A university-affiliated teaching hospital between June 2014 and July 2015. PATIENTS A total of 102 patients who underwent EBUS-TBNA were randomly allocated to two groups (48 DEX group, 54 MDZ group). INTERVENTIONS DEX group received 0.25 to 0.75 μg kg-1 h-1 (start with 0.5 μg kg-1 h-1, modulated in three steps from 0.25 to 0.75 μg kg-1 h-1) of DEX after a loading dose of 0.25 μg kg-1 h-1 for 10 min to maintain a Ramsay Sedation Scale (RSS) of 3 to 5. If the patient was agitated, 1 mg of MDZ bolus was used as a rescue drug. Patients in the MDZ group initially received 0.05 mg kg-1 of MDZ as a bolus. For maintenance and rescue, 1 mg of MDZ bolus was used. MAIN OUTCOME MEASURES The primary outcome was the presence of oxygen desaturation. Secondary outcomes were level of sedation (Ramsay Sedation Scale score), cough score, sedation and procedure satisfaction score. RESULTS The baseline characteristics of the patients, duration of EBUS-TBNA procedures and the use of rescue MDZ were not different between the groups. There was no significant difference in desaturation events between the DEX and MDZ groups (56.3 and 68.5%, respectively; P = 0.20). The level of sedation and the sedation satisfaction scores were similar between the two groups. However, cough score was significantly lower in the DEX group (41.9 vs. 53.4; P = 0.02). CONCLUSION The use of DEX during EBUS-TBNA was not superior to MDZ in terms of oxygen desaturation. TRIAL REGISTRATION Clinicaltrials.gov identifier: NCT02157818.",2021,"However, cough score was significantly lower in the DEX group (41.9 vs. 53.4; P = 0.02). ","['sedation during endobronchial ultrasound-guided transbronchial needle aspiration', 'A university-affiliated teaching hospital between June 2014 and July 2015 PATIENTS', '102 patients who underwent EBUS-TBNA']","['endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA', 'DEX', 'DEX and MDZ', 'Dexmedetomidine', 'DEX with midazolam (MDZ', 'midazolam', 'Dexmedetomidine (DEX', 'MDZ']","['presence of oxygen desaturation', 'cough score', 'desaturation events', 'level of sedation (Ramsay Sedation Scale score), cough score, sedation and procedure satisfaction score', 'level of sedation and the sedation satisfaction scores']","[{'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C3160856', 'cui_str': 'Endobronchial ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}, {'cui': 'C0181959', 'cui_str': 'Aspiration needle'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3160856', 'cui_str': 'Endobronchial ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}, {'cui': 'C0181959', 'cui_str': 'Aspiration needle'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0559295', 'cui_str': 'Ramsay sedation scale'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",102.0,0.397868,"However, cough score was significantly lower in the DEX group (41.9 vs. 53.4; P = 0.02). ","[{'ForeName': 'Junghyun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'From the Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University College of Medicine (JK, SMC, YSP, C-HL, S-ML, CGY,YWK, JL), Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, National Medical Center, Seoul, Republic of Korea (JK).'}, {'ForeName': 'Sun Mi', 'Initials': 'SM', 'LastName': 'Choi', 'Affiliation': ''}, {'ForeName': 'Young Sik', 'Initials': 'YS', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Chang-Hoon', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Sang-Min', 'Initials': 'SM', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Chul-Gyu', 'Initials': 'CG', 'LastName': 'Yoo', 'Affiliation': ''}, {'ForeName': 'Young Whan', 'Initials': 'YW', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Jinwoo', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001370'] 964,33123781,Otoplasty: Rasps or Puncture Needles? A Clinical Trial.,"BACKGROUND Up to 25% of otoplasties can lead to complications, indicating the need for technical refinement. Stenström's anterior auricular cartilage scoring is used in combination with Mustardé's technique to treat the antihelix deformity in several series, with good results. Both can be performed with different instruments such as rasps or puncture needles. OBJECTIVES This study aims to compare the use of puncture needles and rasps for anterior cartilage scoring in otoplasty. The association of Stenström and Mustardé were the basic technique. Anatomical and aesthetic endpoints were assessed. We also reviewed postoperative complications. METHODS Forty-two patients with prominent ears and no previous surgery were randomly assigned needle or rasps technique. They were operated on by the first-year plastic surgery resident in the years of 2014 and 2019. The patients were followed up and reviewed at days 2 and 15, as well as 1, 3 and 6 months postoperatively. The endpoints were evaluated through pre- and postoperative photographs by four experienced plastic surgeons unaware of the techniques used in each case. Patient satisfaction was searched by a ""yes"" or ""no"" question. Surgical time and postoperative edema were evaluated in 20 patients (2014 group). RESULTS There were no statistical differences between the groups in terms of overall results, symmetry, antihelix shape or cartilage fracture. Ninety-five percent of the patients were satisfied with the outcome. The needle technique resulted in less postoperative edema and shorter surgical time. CONCLUSION Anterior cartilage scoring used in combination with posterior mattress sutures to treat poorly formed antihelical fold has good and similar results when performed with rasps or puncture needles, even in unexperienced hands. The needle has the advantage of leading to a comparable surgical time and less postoperative edema, while not requiring any special surgical instrument. LEVEL OF EVIDENCE IV This journal requires that authors assign a level of evidence to each article. For a full description of these evidence-based medicine ratings, please refer to the table of contents or the online instructions to authors www.springer.com/00266 .",2021,"There were no statistical differences between the groups in terms of overall results, symmetry, antihelix shape or cartilage fracture.","['20 patients (2014 group', 'otoplasty', 'Forty-two patients with prominent ears and no previous surgery']","['puncture needles and rasps', 'IV', 'needle or rasps technique']","['postoperative edema and shorter surgical time', 'Surgical time and postoperative edema', 'overall results, symmetry, antihelix shape or cartilage fracture']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0868838', 'cui_str': 'Repair of external ear'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C1305420', 'cui_str': 'Prominent ear'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0995147', 'cui_str': 'Rasp'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0229308', 'cui_str': 'Antihelix structure'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C1564560', 'cui_str': 'Cartilage Fractures'}]",42.0,0.0359251,"There were no statistical differences between the groups in terms of overall results, symmetry, antihelix shape or cartilage fracture.","[{'ForeName': 'Eduardo Madalosso', 'Initials': 'EM', 'LastName': 'Zanin', 'Affiliation': 'Division of Plastic Surgery, Hospital de Clínicas de Porto Alegre, 2350, Ramiro Barcelos st, Porto Alegre-RS, 90035-007, Brazil. eduardo.zanin@gmail.com.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Maximiliano', 'Affiliation': 'Division of Plastic Surgery, Hospital de Clínicas de Porto Alegre, 2350, Ramiro Barcelos st, Porto Alegre-RS, 90035-007, Brazil.'}, {'ForeName': 'Antônio Carlos Pinto', 'Initials': 'ACP', 'LastName': 'Oliveira', 'Affiliation': 'Division of Plastic Surgery, Hospital de Clínicas de Porto Alegre, 2350, Ramiro Barcelos st, Porto Alegre-RS, 90035-007, Brazil.'}, {'ForeName': 'Nícolas Endrigo', 'Initials': 'NE', 'LastName': 'Arpini', 'Affiliation': 'Universidade Federal Do Rio Grande Do Sul Medical School, Porto Alegre-RS, Brazil.'}, {'ForeName': 'Daniele Walter', 'Initials': 'DW', 'LastName': 'Duarte', 'Affiliation': 'Division of Plastic Surgery, Hospital de Clínicas de Porto Alegre, 2350, Ramiro Barcelos st, Porto Alegre-RS, 90035-007, Brazil.'}, {'ForeName': 'Ciro Paz', 'Initials': 'CP', 'LastName': 'Portinho', 'Affiliation': 'Division of Plastic Surgery, Hospital de Clínicas de Porto Alegre, 2350, Ramiro Barcelos st, Porto Alegre-RS, 90035-007, Brazil.'}, {'ForeName': 'Marcus Vinicius Martins', 'Initials': 'MVM', 'LastName': 'Collares', 'Affiliation': 'Head of the Plastic Surgery Division, Hospital de Clínicas de Porto Alegre, Porto Alegre-RS, Brazil.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01972-z'] 965,33127365,Discontinuing Nasal Continuous Positive Airway Pressure in Infants ≤32 Weeks of Gestational Age: A Randomized Control Trial.,"OBJECTIVES To compare immediate cessation of nasal continuous positive airway pressure (NCPAP) vs a stepwise decrease in pressure on the duration of NCPAP therapy in infants born prematurely. STUDY DESIGN A single center study in infants 23 0 -32 6  weeks of gestational age. NCPAP was stopped either at 5 cm H 2 O (control) or 3 cm H 2 O after a stepwise pressure wean (wean) using defined stability and failure criteria. Primary outcome is total NCPAP days. RESULTS We enrolled 226 infants; 116 were randomly assigned to control and 110 to the wean group. There was no difference in the total NCPAP days between groups (median [25th, 75th percentiles] 16 [5, 36] vs 14 [7, 33] respectively). There were no differences between groups in secondary outcomes, including duration of hospital stay, critical care days, and oxygen supplementation. A higher proportion of control infants failed the initial attempt to discontinue NCPAP (43% vs 27%, respectively; P < .01) and required ≥2 attempts (20% vs 5%, respectively; P < .01). In addition, infants 23-27 weeks of gestational age in the wean group were 2.4-times more likely to successfully stop NCPAP at the first attempt (P = .02) vs controls. CONCLUSIONS Discontinuation of NCPAP after a gradual pressure wean to 3 cm H 2 O did not decrease the duration of NCPAP therapy compared with stopping from 5 cm H 2 O in infants ≤32 weeks of gestational age. However, weaning decreased failed initial attempts to stop NCPAP, particularly among infants <28 weeks of gestational age. TRIAL REGISTRATION Clinicaltrials.gov: NCT02064712.",2021,"There was no difference in the total NCPAP days between groups (median (25 th ,75 th centiles) 16 (5,36) vs 14 (7,33) respectively).","['We enrolled 226 infants; 116', 'infants 23 0 -32 6 weeks gestational age (GA', 'Weeks Gestational Age', 'infants born prematurely', 'Infants ≤32']","['NCPAP', 'nasal continuous positive airway pressure (NCPAP', 'Discontinuing Nasal Continuous Positive Airway Pressure']","['duration of hospital stay, critical care days and oxygen supplementation', 'duration of NCPAP therapy', 'total NCPAP days']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}]","[{'cui': 'C1258045', 'cui_str': 'nCPAP Ventilation'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}, {'cui': 'C1258045', 'cui_str': 'nCPAP Ventilation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",226.0,0.0528342,"There was no difference in the total NCPAP days between groups (median (25 th ,75 th centiles) 16 (5,36) vs 14 (7,33) respectively).","[{'ForeName': 'Venkatakrishna', 'Initials': 'V', 'LastName': 'Kakkilaya', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, University of Texas Southwestern Medical Center, Dallas, TX. Electronic address: venkat.kakkilaya@utsouthwestern.edu.'}, {'ForeName': 'Anson', 'Initials': 'A', 'LastName': 'Tang', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Sheron', 'Initials': 'S', 'LastName': 'Wagner', 'Affiliation': 'Parkland Health and Hospital System, Dallas, TX.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Ridpath', 'Affiliation': 'Parkland Health and Hospital System, Dallas, TX.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ibrahim', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'L Steven', 'Initials': 'LS', 'LastName': 'Brown', 'Affiliation': 'Parkland Health and Hospital System, Dallas, TX.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Rosenfeld', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, University of Texas Southwestern Medical Center, Dallas, TX.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.10.045'] 966,33128036,Meal replacement by formula diet reduces weight more than a lifestyle intervention alone in patients with overweight or obesity and accompanied cardiovascular risk factors-the ACOORH trial.,"BACKGROUND As formula diets have demonstrated to be effective in reducing weight, we hypothesised that in patients with overweight or obesity and accompanied cardiovascular risk factors, combining a liquid formula diet with a lifestyle intervention is superior in reducing weight and improving cardiovascular risk factors than lifestyle intervention alone. METHODS In this multicenter RCT 463 participants with overweight or obesity (BMI: 27-35 kg/m²; at least one additional co-morbidity of the metabolic syndrome) were randomised (1:2) into either a control group with lifestyle intervention only (CON, n = 155) or a lifestyle intervention group including a liquid meal replacement (INT, n = 308). Both groups used telemonitoring devices (scales and pedometers), received information on healthy diet and were instructed to increase physical activity. Telemonitoring devices automatically transferred data into a personalised online portal and acquired data were discussed. INT obtained a liquid meal replacement substituting three meals/day (~1200 kcal) within the first week. During weeks 2-4, participants replaced two meals/day and during weeks 5-26 only one meal/day was substituted (1300-1500 kcal/day). Follow-up was conducted after 52 weeks. Intention-to-treat analyses were performed. Primary outcome was weight change. Secondary outcomes comprised changes in cardiometabolic risk factors including body composition and laboratory parameters. RESULTS From the starting cohort 360 (78%, INT: n = 244; CON: n = 116) and 317 (68%, INT: n = 216; CON: n = 101) participants completed the 26-weeks intervention phase and the 52-weeks follow-up. The estimated treatment difference (ETD) between both groups was -3.2 kg [-4.0; -2.5] (P < 0.001) after 12 weeks and -1.8 kg [-2.8; -0.8] (P < 0.001) after 52 weeks. CONCLUSIONS A low-intensity lifestyle intervention combined with a liquid meal replacement is superior regarding weight reduction and improvement of cardiovascular risk factors than lifestyle intervention alone.",2021,P < 0.001) after 12 weeks and -1.8 kg,"['patients with overweight or obesity and accompanied cardiovascular risk factors', 'multicenter RCT 463 participants with overweight or obesity (BMI: 27-35\u2009kg/m²; at least one additional co-morbidity of the metabolic syndrome', 'patients with overweight or obesity and accompanied cardiovascular risk factors-the ACOORH trial', '101) participants completed the 26-weeks intervention phase and the 52-weeks follow-up']","['Meal replacement by formula diet', 'control group with lifestyle intervention only (CON, n\u2009=\u2009155) or a lifestyle intervention group including a liquid meal replacement', 'telemonitoring devices (scales and pedometers), received information on healthy diet']","['cardiovascular risk factors', 'weight change', 'changes in cardiometabolic risk factors including body composition and laboratory parameters']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",463.0,0.0479771,P < 0.001) after 12 weeks and -1.8 kg,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Halle', 'Affiliation': 'Department of Prevention, Rehabilitation and Sports Medicine, Klinikum rechts der Isar, Technical University of Munich (TUM), Munich, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Röhling', 'Affiliation': 'West-German Center of Diabetes and Health, Düsseldorf Catholic Hospital Group, Dusseldorf, Germany. martin.roehling@vkkd-kliniken.de.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Banzer', 'Affiliation': 'Department of Sports Medicine, Institute for Sports and Sport Science, University of Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Klaus Michael', 'Initials': 'KM', 'LastName': 'Braumann', 'Affiliation': 'Faculty of Psychology and Human Movement Sciences, Department of Sports and Movement Medicine, University of Hamburg, Hamburg, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Kempf', 'Affiliation': 'West-German Center of Diabetes and Health, Düsseldorf Catholic Hospital Group, Dusseldorf, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'McCarthy', 'Affiliation': 'Public Health Nutrition Research Group, London Metropolitan University, London, UK.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Schaller', 'Affiliation': 'Department of Prevention, Rehabilitation and Sports Medicine, Klinikum rechts der Isar, Technical University of Munich (TUM), Munich, Germany.'}, {'ForeName': 'Hans Georg', 'Initials': 'HG', 'LastName': 'Predel', 'Affiliation': 'Institute of Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Scholze', 'Affiliation': 'KARDIOS, Cardiologists in Berlin, Berlin, Germany.'}, {'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Führer-Sakel', 'Affiliation': 'Department of Endocrinology, Diabetes and Metabolism and Division of Laboratory Research, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Toplak', 'Affiliation': 'Department of Medicine, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Aloys', 'Initials': 'A', 'LastName': 'Berg', 'Affiliation': 'Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of clinical nutrition,['10.1038/s41430-020-00783-4'] 967,33128138,A comparative prospective study between stemmed versus an unstemmed tibial component in total knee arthroplasty in obese patients.,"BACKGROUND There is no consensus in the literature regarding the patients with obesity who do well with TKA, or this group is at risk of a variety of complications. Implant choices between the two types of implants which either long or standard stem can improve the likelihood that a patient with obesity will achieve high scores for function and quality of life after TKA. METHODS This prospective clinical study included 200 patients who were categorized into two groups: group (1) traditional (standard) unstemmed cemented tibial tray (n = 100 patients) and group (2) stemmed cemented tibial tray with the cementless press-fit stem (n = 100 patients). RESULTS The average follow-up was (7.6 ± 1 years) (range from 6.5 up to 10 years). The average age of the stemmed group was 55.69 ± 8.45 and for the unstemmed group was 57.3 ± 7.8. The average BMI for the stemmed patients was 38.84 ± 3.89, while for the standard (unstemmed) group was 40.0 ± 3.95. Functional results showed significant improvement in both groups but more in the stemmed group (LS) as the difference and change between pre and post were more significant at long stem (P > 0.001). CONCLUSION Based on our results, there were significant improvements in both groups either stemmed or unstemmed TKA but more in the stemmed group which had higher functional outcomes compared to the unstemmed group. LEVEL OF EVIDENCE IV.",2021,", there were significant improvements in both groups either stemmed or unstemmed TKA","['n\u2009=\u2009100 patients', 'total knee arthroplasty in obese patients', '200 patients who were categorized into two groups: group (1', 'patients with obesity who do well with']","['traditional (standard) unstemmed cemented tibial tray (n\u2009=\u2009100 patients) and group (2) stemmed cemented tibial tray with the cementless press-fit stem', 'unstemmed tibial component', 'TKA']","['functional outcomes', 'average BMI']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0184054', 'cui_str': 'Tray'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0441550', 'cui_str': 'Press-fit component fixation'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",200.0,0.0211977,", there were significant improvements in both groups either stemmed or unstemmed TKA","[{'ForeName': 'Mohamed Mansour', 'Initials': 'MM', 'LastName': 'Elzohairy', 'Affiliation': 'Faculty of Medicine, Zagazig University, Zagazig city, 4451, Ash Sharqia Governorate, Egypt. elzohairy.me@gmail.com.'}, {'ForeName': 'Sherif Mohamed', 'Initials': 'SM', 'LastName': 'Elaidy', 'Affiliation': 'Faculty of Medicine, Zagazig University, Zagazig city, 4451, Ash Sharqia Governorate, Egypt.'}, {'ForeName': 'Mohamed Elsadek', 'Initials': 'ME', 'LastName': 'Attia', 'Affiliation': 'Faculty of Medicine, Zagazig University, Zagazig city, 4451, Ash Sharqia Governorate, Egypt.'}]",European journal of orthopaedic surgery & traumatology : orthopedie traumatologie,['10.1007/s00590-020-02816-x'] 968,33131314,Factors Associated With Failure to Achieve the Intensive Blood Pressure Target in the Systolic Blood Pressure Intervention Trial (SPRINT).,"SPRINT (Systolic Blood Pressure Intervention Trial) found that randomization of nondiabetic participants at high cardiovascular risk to an intensive (systolic blood pressure [SBP] <120 mm Hg) versus standard (SBP <140 mm Hg) target resulted in 25% risk reduction in the first cardiovascular composite event (ie, cardiovascular death or nonfatal myocardial infarction, stroke, or hospitalization for heart failure) and a 27% risk reduction in all-cause mortality. In this post hoc analysis, we sought to determine the factors associated with failure to achieve the SBP target in 4678 SPRINT participants randomized to the intensive treatment group. Using a generalized estimating equation model, we assessed variables associated with failure to achieve the intensive SBP target as a repeated outcome collected during serial follow-up visits, including the occurrence of serious adverse events. In the multivariable model adjusted for baseline demographic, clinical, and laboratory variables, older age, higher SBP, underlying chronic kidney disease, higher number of antihypertensives, and moderate cognitive impairment at screening were associated with failure to achieve the intensive SBP target. Occurrence of a serious adverse event during the trial was associated with 20% higher odds of failure to achieve the SBP target. Participants of Hispanic ethnicity had 47% lower odds of failure to achieve the intensive SBP target relative to non-Hispanic Whites. Understanding barriers to achieving intensive SBP targets should allow clinicians to optimize management of hypertension in patients at high risk for cardiovascular disease.",2020,Participants of Hispanic ethnicity had 47% lower odds of failure to achieve the intensive SBP target relative to non-Hispanic Whites.,"['nondiabetic participants at high cardiovascular risk to an intensive (systolic blood pressure [SBP] <120 mm Hg', 'patients at high risk for cardiovascular disease']",[],"['cardiovascular composite event (ie, cardiovascular death or nonfatal myocardial infarction, stroke, or hospitalization for heart failure']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]",[],"[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",4678.0,0.0459267,Participants of Hispanic ethnicity had 47% lower odds of failure to achieve the intensive SBP target relative to non-Hispanic Whites.,"[{'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Wang', 'Affiliation': 'From the Division of Nephrology, Department of Medicine, Stanford University, Palo Alto, CA.'}, {'ForeName': 'Margaret R', 'Initials': 'MR', 'LastName': 'Stedman', 'Affiliation': 'From the Division of Nephrology, Department of Medicine, Stanford University, Palo Alto, CA.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'From the Division of Nephrology, Department of Medicine, Stanford University, Palo Alto, CA.'}, {'ForeName': 'Tara I', 'Initials': 'TI', 'LastName': 'Chang', 'Affiliation': 'From the Division of Nephrology, Department of Medicine, Stanford University, Palo Alto, CA.'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.16155'] 969,33135283,Assessing clinical education tools for expanded carrier screening.,"Expanded carrier screening (ECS) is increasingly offered to a broader population and raises challenges of how to best educate and counsel the volume of screened individuals. For this study, we compared three educational tools (brochure, video and comic) about ECS on knowledge and decision making. A convenience online sample of 151 pregnant women was randomized to one of three groups (Video, n = 42; Comic n = 54; Brochure n = 55). Knowledge scores were significantly higher for the comic group compared to the video or the brochure groups (p < .001). No significant differences in preparation for decision making, decisional conflict, or perceptions of shared decision making were identified between the study groups. This study suggests that a comic about ECS may improve patient attention and retention of information. The use of graphic narratives may enable individuals to better understand medical information in general.",2021,"No significant differences in preparation for decision making, decisional conflict, or perceptions of shared decision making were identified between the study groups.",['151 pregnant women'],"['ECS', 'Expanded carrier screening (ECS']","['preparation for decision making, decisional conflict, or perceptions of shared decision making', 'Knowledge scores', 'patient attention and retention of information']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",151.0,0.0424223,"No significant differences in preparation for decision making, decisional conflict, or perceptions of shared decision making were identified between the study groups.","[{'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Dugger', 'Affiliation': 'Graduate Program in Genetic Counseling, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Hannah S', 'Initials': 'HS', 'LastName': 'Anderson', 'Affiliation': 'ARUP Laboratories, Salt Lake City, UT, USA.'}, {'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'Miller', 'Affiliation': 'ARUP Laboratories, Salt Lake City, UT, USA.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Wong', 'Affiliation': 'College of Nursing, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Erin P', 'Initials': 'EP', 'LastName': 'Johnson', 'Affiliation': 'Department of Ob/Gyn, School of Medicine, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Rothwell', 'Affiliation': 'Department of Ob/Gyn, School of Medicine, University of Utah, Salt Lake City, UT, USA.'}]",Journal of genetic counseling,['10.1002/jgc4.1349'] 970,33138708,Efficacy and Safety of Pharmacotherapeutic Smoking Cessation Aids in Schizophrenia Spectrum Disorders: Subgroup Analysis of EAGLES.,"OBJECTIVE This study aimed to evaluate the efficacy and safety of varenicline, bupropion, and nicotine replacement therapy (NRT) among smokers with schizophrenia spectrum disorders in post hoc analyses of Evaluating Adverse Events in a Global Smoking Cessation Study data. METHODS Smokers with schizophrenia spectrum disorder (N=390) and without a psychiatric illness (control group, N=4,028) were randomly assigned to receive varenicline, bupropion, NRT patch, or placebo for 12 weeks. Outcomes included abstinence rates during treatment and follow-up, number needed to treat (NNT) for abstinence, incidence of neuropsychiatric adverse events (NPSAEs), and temporal relationship between NPSAEs and abstinence status. RESULTS Smokers with schizophrenia smoked more and had greater dependence and fewer prior trials of cessation pharmacotherapy at baseline. At each time point, smokers with schizophrenia assigned to varenicline had significantly greater odds of abstinence compared with their matched placebo group, with NNT comparable to the control group. Bupropion and NRT increased odds of abstinence; confidence intervals (CIs) included 1 for some comparisons, and NNT for smokers with schizophrenia was greater than for the control group. No treatment was associated with significantly more NPSAEs, compared with placebo, in either cohort. The estimated NPSAE rate was 5% (95% CI=3.0-7.7) for smokers with schizophrenia and 1% (95% CI=0.6-2.1) for the control group. Over one-third of NPSAEs occurred during partial or full abstinence, suggesting a multifactorial nature. CONCLUSIONS For smokers with schizophrenia, varenicline led to significantly higher abstinence rates, and NNT was comparable to the control group. A significant proportion of NPSAEs occurred during early abstinence. No treatment significantly increased NPSAE prevalence.",2021,"For smokers with schizophrenia, varenicline led to significantly higher abstinence rates, and NNT was comparable to the control group.","['Smokers with schizophrenia spectrum disorder (N=390) and without a psychiatric illness (control group, N=4,028', 'Schizophrenia Spectrum Disorders', 'smokers with schizophrenia spectrum disorders']","['varenicline', 'varenicline, bupropion, NRT patch, or placebo', 'Bupropion and NRT', 'placebo', 'varenicline, bupropion, and nicotine replacement therapy (NRT', 'Pharmacotherapeutic Smoking Cessation Aids']","['odds of abstinence', 'odds of abstinence; confidence intervals (CIs', 'efficacy and safety', 'abstinence rates during treatment and follow-up, number needed to treat (NNT) for abstinence, incidence of neuropsychiatric adverse events (NPSAEs), and temporal relationship between NPSAEs and abstinence status', 'proportion of NPSAEs', 'NPSAE prevalence', 'Efficacy and Safety', 'estimated NPSAE rate', 'abstinence rates, and NNT']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449235', 'cui_str': 'Temporal relationship'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",4028.0,0.11254,"For smokers with schizophrenia, varenicline led to significantly higher abstinence rates, and NNT was comparable to the control group.","[{'ForeName': 'A Eden', 'Initials': 'AE', 'LastName': 'Evins', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston (Evins, Maravic); Department of Psychiatry, Harvard Medical School, Boston (Evins); Department of Epidemiology and Public Health, University College London, London (West); Departments of Medicine, Biopharmaceutical Sciences, Psychiatry, and Clinical Pharmacy, University of California, San Francisco (Benowitz); Pfizer, New York (Russ, Lawrence, McRae); Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle (Heffner); Department of Psychiatry, University of California, San Diego (Anthenelli).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'West', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston (Evins, Maravic); Department of Psychiatry, Harvard Medical School, Boston (Evins); Department of Epidemiology and Public Health, University College London, London (West); Departments of Medicine, Biopharmaceutical Sciences, Psychiatry, and Clinical Pharmacy, University of California, San Francisco (Benowitz); Pfizer, New York (Russ, Lawrence, McRae); Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle (Heffner); Department of Psychiatry, University of California, San Diego (Anthenelli).'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Benowitz', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston (Evins, Maravic); Department of Psychiatry, Harvard Medical School, Boston (Evins); Department of Epidemiology and Public Health, University College London, London (West); Departments of Medicine, Biopharmaceutical Sciences, Psychiatry, and Clinical Pharmacy, University of California, San Francisco (Benowitz); Pfizer, New York (Russ, Lawrence, McRae); Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle (Heffner); Department of Psychiatry, University of California, San Diego (Anthenelli).'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Russ', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston (Evins, Maravic); Department of Psychiatry, Harvard Medical School, Boston (Evins); Department of Epidemiology and Public Health, University College London, London (West); Departments of Medicine, Biopharmaceutical Sciences, Psychiatry, and Clinical Pharmacy, University of California, San Francisco (Benowitz); Pfizer, New York (Russ, Lawrence, McRae); Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle (Heffner); Department of Psychiatry, University of California, San Diego (Anthenelli).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lawrence', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston (Evins, Maravic); Department of Psychiatry, Harvard Medical School, Boston (Evins); Department of Epidemiology and Public Health, University College London, London (West); Departments of Medicine, Biopharmaceutical Sciences, Psychiatry, and Clinical Pharmacy, University of California, San Francisco (Benowitz); Pfizer, New York (Russ, Lawrence, McRae); Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle (Heffner); Department of Psychiatry, University of California, San Diego (Anthenelli).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'McRae', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston (Evins, Maravic); Department of Psychiatry, Harvard Medical School, Boston (Evins); Department of Epidemiology and Public Health, University College London, London (West); Departments of Medicine, Biopharmaceutical Sciences, Psychiatry, and Clinical Pharmacy, University of California, San Francisco (Benowitz); Pfizer, New York (Russ, Lawrence, McRae); Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle (Heffner); Department of Psychiatry, University of California, San Diego (Anthenelli).'}, {'ForeName': 'Melissa Culhane', 'Initials': 'MC', 'LastName': 'Maravic', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston (Evins, Maravic); Department of Psychiatry, Harvard Medical School, Boston (Evins); Department of Epidemiology and Public Health, University College London, London (West); Departments of Medicine, Biopharmaceutical Sciences, Psychiatry, and Clinical Pharmacy, University of California, San Francisco (Benowitz); Pfizer, New York (Russ, Lawrence, McRae); Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle (Heffner); Department of Psychiatry, University of California, San Diego (Anthenelli).'}, {'ForeName': 'Jaimee L', 'Initials': 'JL', 'LastName': 'Heffner', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston (Evins, Maravic); Department of Psychiatry, Harvard Medical School, Boston (Evins); Department of Epidemiology and Public Health, University College London, London (West); Departments of Medicine, Biopharmaceutical Sciences, Psychiatry, and Clinical Pharmacy, University of California, San Francisco (Benowitz); Pfizer, New York (Russ, Lawrence, McRae); Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle (Heffner); Department of Psychiatry, University of California, San Diego (Anthenelli).'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Anthenelli', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston (Evins, Maravic); Department of Psychiatry, Harvard Medical School, Boston (Evins); Department of Epidemiology and Public Health, University College London, London (West); Departments of Medicine, Biopharmaceutical Sciences, Psychiatry, and Clinical Pharmacy, University of California, San Francisco (Benowitz); Pfizer, New York (Russ, Lawrence, McRae); Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle (Heffner); Department of Psychiatry, University of California, San Diego (Anthenelli).'}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.202000032'] 971,33140841,Experiences of induction of labor with a catheter - A prospective randomized controlled trial comparing the outpatient and inpatient setting.,"INTRODUCTION Approximately every fourth labor is induced. In Finland, when labor is induced, it is commonly carried out with a catheter in the inpatient (IP) setting. However, in uncomplicated, full-term pregnancies, induction of labor (IOL) in the outpatient (OP) setting is also possible. Nevertheless, there is only a limited amount of information about the experiences of IOL in OP setting. Our study compared the experiences of catheter IOL in OP and IP settings. MATERIAL AND METHODS We performed a prospective randomized study, including 113 women with uncomplicated full-term pregnancies with planned IOL. After catheter insertion, women were randomized into OP or IP settings: after dropouts, there were 53 women in the OP group and 54 in the IP. The experiences of IOL were evaluated with three sets of visual analog scale (VAS) questionnaires: the general experience questionnaire (eight questions), the concurrent induction experience questionnaire (1, 5, 9, 13 hours; nine questions) and the postpartum experience questionnaire (14 questions). RESULTS Both groups had low VAS scores, indicating good experiences of IOL. Women in the OP group were less satisfied (mean VAS difference Δ = 7.8, P = .015) and more anxious (Δ = 4.8, P = .008) than were women in the IP group. In the course of the IOL, all women became less satisfied (Δ = 8.4, P = .001), had more contraction pain (Δ = 8.9, P = .020) and had a higher frequency of contractions (Δ = 9.9, P = .004) but they were more relaxed and experienced less fear (Δ = 6.9, P = .036, Δ = 5.3, P = .001, respectively). There was no interaction between group and time. According to the postpartum experience questionnaire, both groups had a similar good general experience of IOL (P = .736) but the OP group had more fear (Δ = 9.5, P = .009) and was more anxious (Δ = 9.0, P = .007). Most of the women would choose catheter IOL in a subsequent pregnancy (OP 82.6%, IP 87.0%). CONCLUSIONS The women in the OP setting were less satisfied and more anxious than were the women in the IP setting. However, the differences were marginal and the general experience after IOL was good. IOL in an OP setting is thus a viable option in low-risk full-term pregnancies. Therefore, when using catheter IOL, both setting options should be available.",2021,"Women in the OP group were less satisfied (mean VAS difference Δ=7.8, P=0.015) and more anxious (Δ=4.8, P=0.008) than women in the IP group.",['113 women with uncomplicated full-term pregnancies with planned IOL'],[],"['frequency of contractions', 'visual analogue scale (VAS) questionnaires', 'low VAS scores', 'anxious', 'contraction pain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0232991', 'cui_str': 'Term pregnancy'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}]",[],"[{'cui': 'C0233126', 'cui_str': 'Frequency of uterine contraction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",113.0,0.0284907,"Women in the OP group were less satisfied (mean VAS difference Δ=7.8, P=0.015) and more anxious (Δ=4.8, P=0.008) than women in the IP group.","[{'ForeName': 'Henna', 'Initials': 'H', 'LastName': 'Haavisto', 'Affiliation': 'Department of Obstetrics and Gynecology, Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Päivi', 'Initials': 'P', 'LastName': 'Polo-Kantola', 'Affiliation': 'Department of Obstetrics and Gynecology, Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Anttila', 'Affiliation': 'Department of Obstetrics and Gynecology, Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Terhi', 'Initials': 'T', 'LastName': 'Kolari', 'Affiliation': 'Department of Biostatistics, University of Turku, Turku, Finland.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Ojala', 'Affiliation': 'Department of Obstetrics and Gynecology, Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Kirsi', 'Initials': 'K', 'LastName': 'Rinne', 'Affiliation': 'Department of Obstetrics and Gynecology, Turku University Hospital and University of Turku, Turku, Finland.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.14037'] 972,33142988,Effects of Advertising on Food Consumption Preferences in Children.,"(1) Background: Childhood obesity is a public health problem. The purpose of this study was to know if exposure to commercial messages which advertise food products exerts any effect on the short-term consumption preferences of 4- to 6-year-old children. (2) Methods: A double-blind and randomized experimental design. Sample consisted of 421 boys and girls from twelve schools in a city in Spain. (3) Results: In three of the four product pairs shown, the products advertised in the intervention were preferred. In the results of applying the model for the first product pair presented, sugared cereals, the predictive variable which best explains the behavior of the preferences expressed is gender (Odds Ratio 0.285 (0.19-0.42); p < 0.05). For the second pair, chocolate cookies, the family's nationality has a strong weight in the model. As regards the regression model calculated for the last pair (filled rolls), the predictive variable which showed having more influence was gender. Boys had a 1.39 times higher risk of selecting the advertised product than girls. (4) Conclusions: The persuasive effect of commercials has shown to be influential in a general, immediate, and significant way only in the case of products with wide brand awareness. This study reinforces the importance of advertising and emphasizes the need to initiate measures to control the content of TV commercials.",2020,"As regards the regression model calculated for the last pair (filled rolls), the predictive variable which showed having more influence was gender.","['4- to 6-year-old children', '421 boys and girls from twelve schools in a city in Spain', 'Children']",[],[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]",[],[],421.0,0.0578635,"As regards the regression model calculated for the last pair (filled rolls), the predictive variable which showed having more influence was gender.","[{'ForeName': 'José Antonio', 'Initials': 'JA', 'LastName': 'Ponce-Blandón', 'Affiliation': 'Red Cross Nursing School, University of Seville, 41009 Seville, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Pabón-Carrasco', 'Affiliation': 'Red Cross Nursing School, University of Seville, 41009 Seville, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Romero-Castillo', 'Affiliation': 'Red Cross Nursing School, University of Seville, 41009 Seville, Spain.'}, {'ForeName': 'Macarena', 'Initials': 'M', 'LastName': 'Romero-Martín', 'Affiliation': 'Red Cross Nursing School, University of Seville, 41009 Seville, Spain.'}, {'ForeName': 'Nerea', 'Initials': 'N', 'LastName': 'Jiménez-Picón', 'Affiliation': 'Red Cross Nursing School, University of Seville, 41009 Seville, Spain.'}, {'ForeName': 'María de Las Mercedes', 'Initials': 'MLM', 'LastName': 'Lomas-Campos', 'Affiliation': 'Faculty of Nursing, Physiotherapy and Podiatry, University of Seville, 41009 Seville, Spain.'}]",Nutrients,['10.3390/nu12113337'] 973,33151597,Effects of exenatide on microvascular reactivity in patients with type 2 diabetes and coronary artery disease: A randomized controlled study.,"OBJECTIVE We studied the effect of the GLP-1RA exenatide on skin microvascular function in patients with T2DM and CAD. METHODS Thirty-five patients with T2DM, CAD, and HbA1C 42-86 mmol/mol were randomized to treatment with exenatide or conventional non-GLP-1-based therapy for 12 weeks. Skin microvascular function was examined in the forearm by LDF and iontophoretic application of acetyl choline and SNP, and by PORH at baseline and after 12 weeks. Blood samples for fasting plasma glucose, HbA1C, and lipid profile were collected. RESULTS At 12 weeks, patients on exenatide showed reductions in HbA1C (from 63.5 ± 13 to 60.7 ± 14 mmol/mol, p = .065), body weight (from 92.6 ± 16 to 89 ± 16 kg, p < .001), and systolic blood pressure (from 141 ± 13 to 134 ± 16 mm Hg, p < .05) as compared to the conventionally treated group. There were no significant changes in skin microvascular function between or within the two groups at follow-up. CONCLUSIONS Three months' daily treatment with the GLP-1RA exenatide in T2DM patients with CAD showed no significant effects on skin microvascular function or blood glucose control, while this study confirms a reduction in body weight and blood pressure by exenatide, as compared to conventional antidiabetic drug treatment.",2021,"Three months daily treatment with the GLP-1RA exenatide in T2DM patients with CAD showed no significant effects on skin microvascular function or blood glucose control, while this study confirms a reduction in body weight and blood pressure by exenatide, as compared to conventional antidiabetic drug treatment.","['Thirty-five patients with T2DM, CAD and glycated hemoglobin (HbA1C) 42-86 mmol/mol', 'patients with type 2 diabetes (T2DM) and coronary artery disease (CAD', 'patients with type 2 diabetes and coronary artery disease']","['exenatide', 'GLP-1RA exenatide', 'acetyl choline and sodium nitroprusside', 'exenatide or conventional non-GLP-1 based therapy', 'glucagon-like peptide-1 receptor agonist (GLP-1RA) exenatide']","['Skin microvascular function', 'HbA1C', 'microvascular reactivity', 'skin microvascular function', 'skin microvascular function or blood glucose control', 'body weight', 'Blood samples for fasting plasma glucose, HbA1C and lipid profile', 'systolic blood pressure', 'body weight and blood pressure']","[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0037533', 'cui_str': 'Sodium nitroprusside'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",35.0,0.0164723,"Three months daily treatment with the GLP-1RA exenatide in T2DM patients with CAD showed no significant effects on skin microvascular function or blood glucose control, while this study confirms a reduction in body weight and blood pressure by exenatide, as compared to conventional antidiabetic drug treatment.","[{'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Östlund Papadogeorgos', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm, Sweden.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Kuhl', 'Affiliation': 'Division of Medicine, Department of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm, Sweden.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Shore', 'Affiliation': 'Diabetes and Vascular Medicine Research Centre, Institute of Biomedical and Clinical Science, Royal Devon and Exeter Hospital, College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kahan', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm, Sweden.'}, {'ForeName': 'Gun', 'Initials': 'G', 'LastName': 'Jörneskog', 'Affiliation': 'Division of Medicine, Department of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm, Sweden.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Kalani', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm, Sweden.'}]","Microcirculation (New York, N.Y. : 1994)",['10.1111/micc.12670'] 974,33161148,A Randomized Controlled Trial of an Exercise Maintenance Intervention in Men and Women After Cardiac Rehabilitation (ECO-PCR Trial).,"BACKGROUND Exercise maintenance interventions are needed for cardiac rehabilitation (CR) graduates to maintain moderate and vigorous-intensity physical activity (MVPA). We tested an exercise facilitator intervention (EFI) to promote exercise maintenance compared with usual care (UC) separately in men and women. METHODS This was a 3-site, randomized (1:1), parallel-group, superiority trial (ECO-PCR). CR graduates were stratified by site and sex and randomly allocated (concealed). EFI participants received a face-to-face introductory session, 5 small-group counseling teleconferences, and 3 personal calls from a trained facilitator over 50 weeks. In-person assessments were undertaken at baseline and 26 and 52 weeks after randomization. The primary outcome was weekly minutes of MVPA, measured by accelerometer. Secondary outcomes were exercise capacity, risk factors, quality of life, and enrollment in community-based exercise programs. Effects were tested with the use of linear mixed models. RESULTS A total of 449 CR graduates (135 women, 314 men) were randomised (n = 226 EFI, n = 223 UC). In the intention-to-treat analysis for men and for women, there were no significant effects for treatment or time on MVPA. In a planned secondary analysis that considered only those adherent to EFI (completed ≥ 66% of sessions; per-protocol), bouted MVPA (ie, in sustained bouts of ≥ 10 min) was higher in women in the EFI group (mean = 132.6 ± 135.2 min/wk at 52 weeks) compared with UC (111.8 ± 113.1; P = 0.013). Regarding secondary outcomes, in women, a treatment group main effect was observed for blood pressure (P = 0.011) and exercise capacity (P = 0.019; both per-protocol) favouring EFI; no other differences were observed. CONCLUSIONS In this trial of CR completers, an EFI showed promise for women, but was ineffective in men.",2020,"In the intent-to-treat analysis for men and for women, there were no significant effects for treatment or time on MVPA.","['men and women', 'men and women post-cardiac rehabilitation (ECO-PCR', '449 graduates (135 women, 314 men']","['face-to-face introductory session, 5 small-group counseling teleconferences, and 3 personal calls from a trained facilitator over 50 weeks', 'exercise facilitator intervention (EFI) to promote exercise maintenance compared to usual care (UC', 'exercise maintenance intervention']","['blood pressure', 'exercise capacity', 'bouted MVPA', 'weekly minutes of MVPA, measured by accelerometer', 'exercise capacity, risk factors, quality of life and enrolment in community-based exercise programs']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C2675227', 'cui_str': 'Endocrine-Cerebroosteodysplasia'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C4517566', 'cui_str': '135'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0237547', 'cui_str': 'Group counseling'}, {'cui': 'C0039450', 'cui_str': 'Teleconference'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",,0.227851,"In the intent-to-treat analysis for men and for women, there were no significant effects for treatment or time on MVPA.","[{'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Reid', 'Affiliation': 'University of Ottawa Heart Institute, Ottawa, Ontario, Canada; University of Ottawa, Ottawa, Ontario, Canada. Electronic address: breid@ottawaheart.ca.'}, {'ForeName': 'Evyanne A', 'Initials': 'EA', 'LastName': 'Wooding', 'Affiliation': 'University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Chris M', 'Initials': 'CM', 'LastName': 'Blanchard', 'Affiliation': 'Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Mahshid', 'Initials': 'M', 'LastName': 'Moghei', 'Affiliation': 'York University, Toronto, Ontario, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Harris', 'Affiliation': 'University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Guy-Anne', 'Initials': 'GA', 'LastName': 'Proulx', 'Affiliation': 'University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Prince', 'Affiliation': 'University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Kerri A', 'Initials': 'KA', 'LastName': 'Mullen', 'Affiliation': 'University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Gabriela Melo', 'Initials': 'GM', 'LastName': 'Ghisi', 'Affiliation': 'University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Murray', 'Initials': 'M', 'LastName': 'Krahn', 'Affiliation': 'University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Chessex', 'Affiliation': 'University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Pipe', 'Affiliation': 'University of Ottawa Heart Institute, Ottawa, Ontario, Canada; University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Mark', 'Affiliation': 'Shoebox, Ottawa, Ontario, Canada.'}, {'ForeName': 'Sherry L', 'Initials': 'SL', 'LastName': 'Grace', 'Affiliation': 'York University, Toronto, Ontario, Canada; University Health Network, University of Toronto, Toronto, Ontario, Canada.'}]",The Canadian journal of cardiology,['10.1016/j.cjca.2020.10.015'] 975,33169704,"Effect of carbon dioxide versus room air insufflation on post-colonoscopic pain: A prospective, randomized, controlled study.","BACKGROUND/AIMS Room air (RA) and carbon dioxide (CO2) are widely used to insufflate the colon to examine the mucosa in colonoscopy. Pain, discomfort, and bloating can be seen during and after colonoscopy secondary to bowel distention. This study aimed to investigate the effect of CO2 on post-procedure pain sensation (PPPS) in comparison with RA. MATERIALS AND METHODS Patients were randomly assigned to the RA and CO2 insufflation groups in a 1:1 ratio. The visual analog scale (VAS) was used to measure the pain before and after the colonoscopy. VAS score of 0 was accepted as the absence of pain and above 0 was accepted as the presence of pain. The primary outcome was to investigate the effect of CO2 insufflation on PPPS. Secondary outcomes were to investigate the other contributing factors affecting PPPS and the effect of CO2 on PPPS in patients with inflammatory bowel disease (IBD). RESULTS A total of 204 patients were enrolled in the study. No significant difference in PPPS was seen between the 2 groups at any point in time after the colonoscopy. Furthermore, there was no significant difference in pain sensation between the CO2 and RA groups in patients with IBD. When we investigated the other contributing factors to pain sensation, body-mass index (BMI) was found to be significant at 30 minutes and BMI and colonoscopy time were found to be significant at 6 hours afterwards. CONCLUSION We found no favorable effect of CO2 insufflation on PPPS in colonoscopy, including in patients with IBD.",2020,No significant difference in PPPS was seen between the 2 groups at any point in time after the colonoscopy.,"['Patients', '204 patients were enrolled in the study', 'patients with inflammatory bowel disease (IBD', 'post-colonoscopic pain', 'patients with IBD']","['CO2 insufflation', 'CO2', 'carbon dioxide versus room air insufflation', 'RA and CO2 insufflation', 'Room air (RA) and carbon dioxide (CO2']","['pain sensation', 'BMI and colonoscopy time', 'Pain, discomfort, and bloating', 'visual analog scale (VAS', 'VAS score', 'PPPS', 'effect of CO2 insufflation on PPPS', 'pain sensation, body-mass index (BMI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0001861', 'cui_str': 'Air'}]","[{'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}]",204.0,0.0274209,No significant difference in PPPS was seen between the 2 groups at any point in time after the colonoscopy.,"[{'ForeName': 'Feyza', 'Initials': 'F', 'LastName': 'Gündüz', 'Affiliation': 'Department of Gastroenterology, Marmara University School of Medicine, İstanbul, Turkey;Marmara University, Institute of Gastroenterology, İstanbul, Turkey.'}, {'ForeName': 'Haluk Tarık', 'Initials': 'HT', 'LastName': 'Kani', 'Affiliation': 'Department of Gastroenterology, Marmara University School of Medicine, İstanbul, Turkey.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Chang', 'Affiliation': 'Division of Gastroenterology, Inflammatory Bowel Disease Center, New York University Langone Health, New York, New York.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Akdeniz', 'Affiliation': 'Department of Medical Education, Marmara University, School of Medicine, İstanbul, Turkey.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Eren', 'Affiliation': 'Marmara University Institute of Gastroenterology, İstanbul, Turkey; Department of Medical Biology, Marmara University School of Medicine, İstanbul, Turkey.'}, {'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Yılmaz', 'Affiliation': 'Department of Gastroenterology, Marmara University School of Medicine, İstanbul, Turkey;Marmara University, Institute of Gastroenterology, İstanbul, Turkey.'}, {'ForeName': 'Yeşim Özen', 'Initials': 'YÖ', 'LastName': 'Alahdab', 'Affiliation': 'Department of Gastroenterology, Marmara University School of Medicine, İstanbul, Turkey;Marmara University, Institute of Gastroenterology, İstanbul, Turkey.'}]",The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology,['10.5152/tjg.2020.20596'] 976,33170444,Cognitive Behavioral Therapy Versus Usual Care Before Bariatric Surgery: One-Year Follow-Up Results of a Randomized Controlled Trial.,"BACKGROUND Although early results of bariatric surgery are beneficial for most patients, some patients regain weight later. Cognitive behavioral therapy (CBT) has been suggested as a way to improve patients' psychological health and maintaining weight loss in the longer term. The added value of preoperative CBT to bariatric surgery was examined. Pre- and posttreatment and 1-year follow-up data are presented. METHODS In a multi-center randomized controlled trial, CBT was compared to a treatment-as-usual (TAU) control group. Measurements were conducted pre- and posttreatment/pre-surgery (T0 and T1) and at 1-year post-surgery (T2). Patients in the intervention group received 10 individual, weekly sessions of preoperative CBT focused on modifying thoughts and behaviors regarding eating behavior, physical exercise, and postoperative life style. Outcome measures included weight change, eating behavior, eating disorders, depression, quality of life, and overall psychological health. RESULTS Though no significant differences between conditions were found per time point, in the CBT, condition scores on external eating, emotional eating, depressive symptoms, and psychological distress decreased significantly more over time between pre- (T0) and posttreatment (T1) pre-surgery compared to TAU. No significant time x condition differences were found at 1-year post-surgery (T2). CONCLUSIONS Compared to TAU, preoperative CBT showed beneficial effects on eating behavior and psychological symptoms only from pretreatment to posttreatment/pre-surgery, but not from pre-surgery to 1-year post-surgery. Preoperative CBT does not seem to contribute to better long-term outcomes post-surgery. Recent studies suggest that the optimal time to initiate psychological treatment may be early in the postoperative period, before significant weight regain has occurred. TRIAL REGISTRATION https://www.trialregister.nl Identifier: Trial NL3960.",2021,"Though no significant differences between conditions were found per time point, in the CBT, condition scores on external eating, emotional eating, depressive symptoms, and psychological distress decreased significantly more over time between pre- (T0) and posttreatment (T1) pre-surgery compared to TAU.",[],"['CBT', 'Cognitive Behavioral Therapy Versus Usual Care Before Bariatric Surgery', 'Cognitive behavioral therapy (CBT', 'TAU, preoperative CBT', '10 individual, weekly sessions of preoperative CBT focused on modifying thoughts and behaviors regarding eating behavior, physical exercise, and postoperative life style']","['CBT, condition scores on external eating, emotional eating, depressive symptoms, and psychological distress', 'weight loss', 'eating behavior and psychological symptoms', 'weight change, eating behavior, eating disorders, depression, quality of life, and overall psychological health']",[],"[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",,0.0558007,"Though no significant differences between conditions were found per time point, in the CBT, condition scores on external eating, emotional eating, depressive symptoms, and psychological distress decreased significantly more over time between pre- (T0) and posttreatment (T1) pre-surgery compared to TAU.","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Paul', 'Affiliation': 'PsyQ Department of Eating Disorders, Rotterdam, Netherlands.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'van der Heiden', 'Affiliation': 'Parnassia Psychiatric Institute, Kiwistraat 43, 2552 DH, The Hague, Netherlands.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'van Hoeken', 'Affiliation': 'Parnassia Psychiatric Institute, Kiwistraat 43, 2552 DH, The Hague, Netherlands.'}, {'ForeName': 'Mathijs', 'Initials': 'M', 'LastName': 'Deen', 'Affiliation': 'Parnassia Psychiatric Institute, Kiwistraat 43, 2552 DH, The Hague, Netherlands.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Vlijm', 'Affiliation': 'Parnassia Psychiatric Institute, Kiwistraat 43, 2552 DH, The Hague, Netherlands.'}, {'ForeName': 'René A', 'Initials': 'RA', 'LastName': 'Klaassen', 'Affiliation': 'Department of Surgery, Maasstad Hospital, Rotterdam, Netherlands.'}, {'ForeName': 'L Ulas', 'Initials': 'LU', 'LastName': 'Biter', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Rotterdam, Netherlands.'}, {'ForeName': 'Hans W', 'Initials': 'HW', 'LastName': 'Hoek', 'Affiliation': 'Parnassia Psychiatric Institute, Kiwistraat 43, 2552 DH, The Hague, Netherlands. w.hoek@parnassiagroep.nl.'}]",Obesity surgery,['10.1007/s11695-020-05081-3'] 977,33172346,Training-induced changes in anterior pelvic tilt: potential implications for hamstring strain injuries management.,"An association has been reported between dynamic anterior pelvic tilt (APT) and hamstring injuries; however, no research has examined if a training-based preventive intervention could alter APT. Therefore, the aim of the present study was to examine if a specific 6-week multimodal intervention, based on the theoretical influence of neighbouring joints and biomechanical interactions between muscles that are inserted to the pelvis, induced changes in APT, during walking gait, hamstring flexibility and trunk endurance. Thirty-five active healthy males volunteered for this single-blind controlled trial and were split into two groups based on baseline data: a control group (CG, n = 20, continued their normal physical activities), and an intervention group (IG, n = 15, performed the intervention programme for 18 sessions over 6 weeks). A significant (p = 0.001) decrease in the APT kinematics during gait, significant increase in the Active Knee Extension Test (p = 0.001), and a significant increase in trunk endurance performance for flexion (p = 0.001), extension (p = 0.001) and side bridge (p = 0.001) were observed, in IG after the 6-week programme, compared to CG.",2021,"A significant (p = 0.001) decrease in the APT kinematics during gait, significant increase in the Active Knee Extension Test (p = 0.001), and a significant increase in trunk endurance performance for flexion (p = 0.001), extension (p = 0.001) and side bridge (p = 0.001) were observed, in IG after the 6-week programme, compared to CG.","['hamstring strain injuries management', 'Thirty-five active healthy males']","['control group (CG, n =\xa020, continued their normal physical activities), and an intervention group (IG, n =\xa015, performed the intervention programme']","['trunk endurance performance for flexion', 'Active Knee Extension Test', 'side bridge', 'APT kinematics']","[{'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C1629036', 'cui_str': 'Pelvic declination'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}]",35.0,0.0154007,"A significant (p = 0.001) decrease in the APT kinematics during gait, significant increase in the Active Knee Extension Test (p = 0.001), and a significant increase in trunk endurance performance for flexion (p = 0.001), extension (p = 0.001) and side bridge (p = 0.001) were observed, in IG after the 6-week programme, compared to CG.","[{'ForeName': 'Jurdan', 'Initials': 'J', 'LastName': 'Mendiguchia', 'Affiliation': 'Department of Physical Therapy, ZENTRUM Rehab and Performance Center, Barañain, Spain.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Gonzalez De la Flor', 'Affiliation': 'Department of Physical Therapy and Sport Medicine, Hospital Universitario Quironsalud Madrid, Madrid, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Mendez-Villanueva', 'Affiliation': 'Qatar Football Association, Doha, Qatar.'}, {'ForeName': 'Jean-Benoît', 'Initials': 'JB', 'LastName': 'Morin', 'Affiliation': ""LAMHESS, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Edouard', 'Affiliation': 'Inter-university Laboratory of Human Movement Science (LIBM EA 7424), University of Lyon, University Jean Monnet, Saint Etienne, France.'}, {'ForeName': 'Mirian Aranzazu', 'Initials': 'MA', 'LastName': 'Garrues', 'Affiliation': 'Faculty of Medicine and Nursing, Physiology Department, University of the Basque Country, Biscay, Spain.'}]",Journal of sports sciences,['10.1080/02640414.2020.1845439'] 978,33180098,"Effect of Vitamin B12 Injection on the Vocal Performance of Professional Singers: A Randomized, Double-blind, Placebo-Controlled, Crossover Trial.","Importance One-third of singers and vocal professionals report experiencing a benefit from empirical vitamin B12 injections for improvement of mild singing-related symptoms (eg, reduced stamina, vocal fatigue, and effort). However, there is no objective evidence to support or refute these claims. Objective To assess the presence and magnitude of the effect of empirical vitamin B12 injection on the vocal performance of singers. Design, Setting, and Participants A randomized, double-blind, placebo-controlled, crossover trial was conducted from November 7, 2017, to November 30, 2018, at an academic voice center among 20 active adult singers without dysphonia but with mild vocal symptoms. Individuals with known or suspected vitamin B12 deficiency or active or recent vitamin B12 treatment were excluded. Analysis was on a per-protocol basis. Interventions Participants were randomized to receive an intramuscular (deltoid) injection of either vitamin B12 (1000 μg of cyanocobalmin) or placebo (0.9% sodium chloride). After a washout period of at least 4 weeks, participants were crossed over to receive the opposite injection. Both the investigators and participants were blinded to the order of injections. Main Outcomes and Measures The participants completed the Singing Voice Handicap Index-10 (SVHI-10), the Voice Fatigue Index (VFI), and the Evaluation of the Ability to Sing Easily (EASE) before each injection and at intervals of 1 hour, 3 hours, 24 hours, 72 hours, and 1 week after the injection. The primary time point assessment was 72 hours after injection, and the SVHI-10 score was the primary outcome measure. Results Twenty singers (10 men; median age, 22 years [range, 19-42 years]) were enrolled. The improvements after either placebo or vitamin B12 injections were comparable to each other. At 72 hours after the vitamin B12 injection, the median difference in the SVHI-10 score was 1 (95% CI, -1 to 2) compared with 3 (95% CI, 0-4) after placebo. The median difference between differences at 72 hours between placebo and vitamin B12 injections were 1.5 (95% CI, -2 to 5) for the SVHI-10, 1 (95% CI, -9 to 9) for the VFI, and -1 (95% CI, -3 to 2) for the EASE. The improvements after both injections failed to reach the estimated minimal clinically important difference. Of the 20 participants, 4 (20%) reached the estimated minimal clinically important difference in their SVHI-10 score after 72 hours for both vitamin B12 and placebo injections. Conclusions and Relevance This randomized, double-blind, placebo-controlled, crossover trial found that after empirical vitamin B12 injection to improve mild voice-related symptoms, the improvement in self-reported voice measures in singers shows no meaningful difference compared with placebo. Trial Registration ClinicalTrials.gov Identifier: NCT03437824.",2021,The improvements after either placebo or vitamin B12 injections were comparable to each other.,"['November 7, 2017, to November 30, 2018, at an academic voice center among 20 active adult singers without dysphonia but with mild vocal symptoms', 'Professional Singers', 'Results\n\n\nTwenty singers (10 men; median age, 22 years [range, 19-42 years]) were enrolled', 'Individuals with known or suspected vitamin B12 deficiency or active or recent vitamin B12 treatment were excluded']","['empirical vitamin B12 injection', 'vitamin B12 injection', 'Vitamin B12 Injection', 'placebo', 'intramuscular (deltoid) injection of either vitamin B12 (1000 μg of cyanocobalmin) or placebo (0.9% sodium chloride', 'placebo or vitamin B12 injections', 'Placebo', 'vitamin B12 injections']","['Singing Voice Handicap Index-10 (SVHI-10), the Voice Fatigue Index (VFI), and the Evaluation of the Ability to Sing Easily (EASE', 'vocal performance of singers', 'mild voice-related symptoms', 'SVHI-10 score', 'Vocal Performance']","[{'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0335076', 'cui_str': 'Singer'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0042847', 'cui_str': 'Cobalamin deficiency'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0184615', 'cui_str': 'Injection of vitamin B12'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0990166', 'cui_str': 'Sodium Chloride 0.154 MEQ/ML'}]","[{'cui': 'C0234857', 'cui_str': 'Singing'}, {'cui': 'C2985106', 'cui_str': 'Voice handicap index'}, {'cui': 'C0241700', 'cui_str': 'Vocal fatigue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C0335076', 'cui_str': 'Singer'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.759751,The improvements after either placebo or vitamin B12 injections were comparable to each other.,"[{'ForeName': 'Hagit', 'Initials': 'H', 'LastName': 'Shoffel-Havakuk', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Rabin Medical Center, Petach Tikva, Israel.'}, {'ForeName': 'Christian X', 'Initials': 'CX', 'LastName': 'Lava', 'Affiliation': 'USC Voice Center, Department of Otolaryngology-Head and Neck Surgery, University of Southern California, Los Angeles.'}, {'ForeName': 'Yonatan', 'Initials': 'Y', 'LastName': 'Reuven', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Rabin Medical Center, Petach Tikva, Israel.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Moog', 'Affiliation': 'USC Voice Center, Department of Otolaryngology-Head and Neck Surgery, University of Southern California, Los Angeles.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Odell', 'Affiliation': 'USC Voice Center, Department of Otolaryngology-Head and Neck Surgery, University of Southern California, Los Angeles.'}, {'ForeName': 'Lindsay S', 'Initials': 'LS', 'LastName': 'Reder', 'Affiliation': 'USC Voice Center, Department of Otolaryngology-Head and Neck Surgery, University of Southern California, Los Angeles.'}, {'ForeName': 'Edie R', 'Initials': 'ER', 'LastName': 'Hapner', 'Affiliation': 'UAB Voice Center, Otolaryngology, University of Alabama, Birmingham.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Johns', 'Affiliation': 'USC Voice Center, Department of Otolaryngology-Head and Neck Surgery, University of Southern California, Los Angeles.'}]",JAMA otolaryngology-- head & neck surgery,['10.1001/jamaoto.2020.4026'] 979,33130153,Cognitive Behavior Therapy Tailored to Anxiety Symptoms Improves Pediatric Functional Abdominal Pain Outcomes: A Randomized Clinical Trial.,"OBJECTIVES To evaluate the feasibility of a stepped care model, and establish the effect of a tailored cognitive behavioral therapy, the Aim to Decrease Anxiety and Pain Treatment (ADAPT), compared with standard medical treatment as usual on pain-related outcomes and anxiety. STUDY DESIGN Eligible patients between the ages of 9 and 14 years with functional abdominal pain disorders (n = 139) received enhanced usual care during their medical visit to a gastroenterologist. Those that failed to respond to enhanced usual care were randomized to receive either a tailored cognitive behavioral therapy (ADAPT) plus medical treatment as usual, or medical treatment as usual only. ADAPT dose (4 sessions of pain management or 6 sessions of pain and anxiety management) was based on presence of clinically significant anxiety. Outcomes included feasibility, based on recruitment and retention rates. Response to ADAPT plus medical treatment as usual vs medical treatment as usual on pain-related outcomes and anxiety measures was also investigated using a structural equation modeling equivalent of a MANCOVA. Anxiety levels and ADAPT dose as moderators of treatment effects were also explored. RESULTS Based on recruitment and retention rates, stepped care was feasible. Enhanced usual care was effective for only 8% of youth. Participants randomized to ADAPT plus medical treatment as usual showed significantly greater improvements in pain-related disability, but not pain levels, and greater improvements in anxiety symptoms compared with those randomized to medical treatment as usual only. Anxiety and ADAPT treatment dose did not moderate the effect of treatment on disability nor pain. CONCLUSIONS Tailoring care based on patient need may be optimal for maximizing the use of limited psychotherapeutic resources while enhancing care. TRIAL REGISTRATION ClinicalTrials.gov: NCT03134950.",2021,"Participants randomized to ADAPT+TAU showed significantly greater improvements in pain-related disability, but not pain levels, and greater improvements in anxiety symptoms compared with those randomized to TAU only.",['Eligible patients between the ages of 9 and 14 years with FAPD (n = 139) received'],"['tailored CBT (ADAPT) plus TAU, or TAU only', 'tailored cognitive behavioral therapy (CBT', 'ADAPT+TAU', 'Cognitive Behavior Therapy', 'ADAPT+TAU versus TAU', 'enhanced usual care (EUC', 'EUC']","['pain-related outcomes and anxiety measures', 'Pediatric Functional Abdominal Pain Outcomes', 'pain levels', 'anxiety symptoms', 'disability nor pain', 'feasibility, based on recruitment and retention rates', 'Anxiety levels', 'pain-related disability', 'Anxiety Symptoms', 'Anxiety and Pain Treatment (ADAPT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191072', 'cui_str': '139'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1609533', 'cui_str': 'Functional abdominal pain'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",,0.0698022,"Participants randomized to ADAPT+TAU showed significantly greater improvements in pain-related disability, but not pain levels, and greater improvements in anxiety symptoms compared with those randomized to TAU only.","[{'ForeName': 'Natoshia R', 'Initials': 'NR', 'LastName': 'Cunningham', 'Affiliation': 'Department of Family Medicine, Michigan State University, Grand Rapids, MI. Electronic address: natoshia@msu.edu.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kalomiris', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Peugh', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH; Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Farrell', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH; Division of Gastroenterology, Hepatology, and Nutrition, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Pentiuk', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH; Division of Gastroenterology, Hepatology, and Nutrition, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Mallon', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH; Division of Gastroenterology, Hepatology, and Nutrition, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Le', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Moorman', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Fussner', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Richa Aggarwal', 'Initials': 'RA', 'LastName': 'Dutta', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Susmita', 'Initials': 'S', 'LastName': 'Kashikar-Zuck', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH; Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.""}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.10.060'] 980,33130956,"SAKK 19/17: safety analysis of first-line durvalumab in patients with PD-L1 positive, advanced nonsmall cell lung cancer and a performance status of 2.","INTRODUCTION The safety of first-line (1L) durvalumab in patients with advanced nonsmall-cell lung cancer (NSCLC) and an Eastern Cooperative Oncology Group (ECOG) performance status of 2 (PS2) is unknown. This is an interim unplanned safety analysis of the study SAKK 19/17 for patients with metastatic NSCLC with programmed death-ligand 1 (PD-L1) expression in ≥ 25% of tumor cells and an ECOG PS2 treated with 1L durvalumab. This safety analysis was triggered by the SAKK data and safety monitoring board due to a high mortality rate observed after the recruitment of the first 21 patients. METHODS This single-arm phase II study recruited patients with metastatic NSCLC with PD-L1 in ≥ 25% and ECOG PS2. Patients received durvalumab 1500 mg every four weeks. The trial aims to recruit 48 patients in total. This report includes safety analyses only. Adverse events (AEs) were assessed using National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) Version 5.0. Efficacy data including the primary endpoint overall survival at 6 months and secondary endpoints (objective response rate, progression-free survival, and quality of life) will be reported at a later time point. RESULTS The data from 21 patients were available at this interim safety analysis. Among these, 13 deaths (13/21; 62%) were reported, including one treatment-related fatal colonic perforation at 9 months after treatment initiation (1/13; 8%). Twelve deaths were not treatment-related (12/13; 92%), and mostly attributed to tumor progression (10/13; 77%). Of note, seven deaths (7/13; 54%) occurred during the first 5 weeks (range 0.6-4.7 weeks) after treatment initiation. Four (4/7; 57%) were respiratory failures attributed to tumor progression. One of these patients (25%) had pre-existing COPD, and three (75%) had baseline dyspnea grade 2-3 related to the tumor. Grade ≥ 3 treatment-related AEs (TRAEs) included colonic perforation (grade 5), abdominal pain, and colitis (grade 3 each) in one patient, and fatigue (grade 3) in another. Other Grade ≥ 3 AEs unrelated to treatment were all of pulmonary origin: lung infections (19%), dyspnea (24%), cough (5%), and bronchial obstruction (5%). CONCLUSIONS 1L durvalumab in patients with ECOG PS2 and metastatic NSCLC with PD-L1 expression ≥ 25% resulted in an unexpectedly high number of fatal early events due to rapid tumor progression. We recommend to avoid treatment with 1 L durvalumab of patients who are highly symptomatic from the tumor, particularly those with respiratory symptoms. The study is continuing its accrual after an amendment excluding these patients.",2021,"Twelve deaths were not treatment-related (12/13; 92%), and mostly attributed to tumor progression (10/13; 77%).","['48 patients in total', 'patients with ECOG PS2 and metastatic NSCLC with PD-L1 expression', 'patients with metastatic NSCLC with programmed death-ligand 1 (PD-L1) expression in\u2009≥\u200925% of tumor cells and an ECOG PS2 treated with 1L durvalumab', 'patients with metastatic NSCLC with PD-L1 in\u2009≥\u200925% and ECOG PS2', 'patients who are highly symptomatic from the tumor, particularly those with respiratory symptoms', 'patients with PD-L1 positive, advanced nonsmall cell lung cancer and a performance status of 2', 'patients with advanced nonsmall-cell lung cancer (NSCLC) and an Eastern Cooperative Oncology Group (ECOG) performance status of 2 (PS2']","['first-line (1L) durvalumab', 'durvalumab']","['dyspnea', 'mortality rate', 'Grade\u2009≥\u20093 treatment-related AEs (TRAEs) included colonic perforation (grade 5), abdominal pain, and colitis', 'pre-existing COPD', 'baseline dyspnea grade 2-3 related to the tumor', 'bronchial obstruction', 'overall survival at 6\xa0months and secondary endpoints (objective response rate, progression-free survival, and quality of life', 'fatal colonic perforation', 'National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}]","[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0347646', 'cui_str': 'Perforation of colon'}, {'cui': 'C1705232', 'cui_str': 'Common terminology criteria for adverse events grade 5'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0009319', 'cui_str': 'Colitis'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0221725', 'cui_str': 'Obstruction of bronchus'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0028275', 'cui_str': 'Terminology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]",21.0,0.123342,"Twelve deaths were not treatment-related (12/13; 92%), and mostly attributed to tumor progression (10/13; 77%).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mark', 'Affiliation': 'Department of Medical Oncology/Hematology, Kantonsspital Graubünden, Loestrasse 170, 7000, Chur, Switzerland. michael.mark@ksgr.ch.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Froesch', 'Affiliation': 'Department of Medical Oncology, EOC-Istituto Oncologico della Svizzera Italiana, Bellinzona, Switzerland.'}, {'ForeName': 'Eric Innocents', 'Initials': 'EI', 'LastName': 'Eboulet', 'Affiliation': 'SAKK Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Addeo', 'Affiliation': 'Department of Oncology, Hôpitaux Universitaires de Genève, Geneva, Switzerland.'}, {'ForeName': 'Miklos', 'Initials': 'M', 'LastName': 'Pless', 'Affiliation': 'Department of Medical Oncology, Kantonsspital Winterthur, Winterthur, Switzerland.'}, {'ForeName': 'Sacha I', 'Initials': 'SI', 'LastName': 'Rothschild', 'Affiliation': 'Department of Medical Oncology, Universitätsspital Basel, Basel, Switzerland.'}, {'ForeName': 'Wolf-Dieter', 'Initials': 'WD', 'LastName': 'Janthur', 'Affiliation': 'Department of Medical Oncology, Kantonsspital Aarau, Aargau, Switzerland.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Burmeister', 'Affiliation': 'Department of Medical Oncology, Spital STS AG Thun/Onko-Netz, Thun, Switzerland.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Friedlaender', 'Affiliation': 'Department of Oncology, Hôpitaux Universitaires de Genève, Geneva, Switzerland.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Schneider', 'Affiliation': 'SAKK Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Metaxas', 'Affiliation': 'Department of Medical Oncology/Hematology, Kantonsspital Graubünden, Loestrasse 170, 7000, Chur, Switzerland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Joerger', 'Affiliation': 'Department of Medical Oncology, Kantonsspital St. Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Wannesson', 'Affiliation': 'Department of Medical Oncology, EOC-Istituto Oncologico della Svizzera Italiana, Bellinzona, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schwitter', 'Affiliation': 'Department of Medical Oncology/Hematology, Kantonsspital Graubünden, Loestrasse 170, 7000, Chur, Switzerland.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Baudoux', 'Affiliation': 'Department of Oncology, Hôpitaux Universitaires de Genève, Geneva, Switzerland.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Weindler', 'Affiliation': 'Department of Medical Oncology, Kantonsspital St. Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Biaggi-Rudolf', 'Affiliation': 'SAKK Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Früh', 'Affiliation': 'Department of Medical Oncology, Kantonsspital St. Gallen, St Gallen, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Cancer immunology, immunotherapy : CII",['10.1007/s00262-020-02757-8'] 981,33148955,The Optimal Dosing Regimen for Tranexamic Acid in Revision Total Hip Arthroplasty: A Multicenter Randomized Clinical Trial.,"BACKGROUND The purpose of this multicenter, randomized trial was to determine the optimal dosing regimen of tranexamic acid (TXA) to minimize perioperative blood loss in revision total hip arthroplasty. METHODS Six centers prospectively randomized 175 patients to 1 of 4 regimens: (1) 1-g intravenous (IV) TXA prior to incision (the single-dose IV group), (2) 1-g IV TXA prior to incision followed by 1-g IV TXA after arthrotomy wound closure (the double-dose IV group), (3) a combination of 1-g IV TXA prior to incision and 1-g intraoperative topical TXA (the combined IV and topical group), or (4) 3 doses totaling 1,950-mg oral TXA (the multidose oral group). Randomization was based on revision subgroups to ensure equivalent group distribution. An a priori power analysis (α = 0.05; β = 0.80) determined that 40 patients per group were required to identify a >1-g/dL difference in postoperative hemoglobin reduction between groups. Per-protocol analysis involved an analysis of variance, Fisher exact tests, and two 1-sided t tests for equivalence. Demographic and surgical variables were equivalent between groups. RESULTS No significant differences were found between TXA regimens when evaluating reduction in hemoglobin (3.4 g/dL for the single-dose IV group, 3.6 g/dL for the double-dose IV group, 3.5 g/dL for the combined IV and topical group, and 3.4 g/dL for the multidose oral group; p = 0.95), calculated blood loss (p = 0.90), or transfusion rates (14% for the single-dose IV group, 18% for the double-dose IV group, 17% for the combined group, and 17% for the multidose oral group; p = 0.96). Equivalence testing revealed that all possible pairings were statistically equivalent, assuming a >1-g/dL difference in hemoglobin reduction as clinically relevant. There was 1 venous thromboembolism, with no differences found between groups (p = 1.00). CONCLUSIONS All 4 TXA groups tested had equivalent blood-sparing properties in the setting of revision total hip arthroplasty, with a single venous thromboembolism reported in this high-risk population. Based on the equivalence between groups, surgeons should utilize whichever of the 4 investigated regimens is best suited for their practice and hospital setting. Given the transfusion rate in revision total hip arthroplasty despite TXA utilization, further work is required in this area. LEVEL OF EVIDENCE Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"No significant differences were found between TXA regimens when evaluating reduction in hemoglobin (3.4 g/dL for the single-dose IV group, 3.6 g/dL for the double-dose IV group, 3.5 g/dL for the combined IV and topical group, and 3.4 g/dL for the multidose oral group; p = 0.95), calculated blood loss (p = 0.90), or transfusion rates (14% for the single-dose IV group, 18% for the double-dose IV group, 17% for the combined group, and 17% for the multidose oral group; p = 0.96).","['revision total hip arthroplasty', 'Revision Total Hip Arthroplasty', 'Six centers prospectively randomized 175 patients to 1 of 4 regimens: (1']","['TXA prior to incision followed by 1-g IV TXA', 'Tranexamic Acid', 'tranexamic acid (TXA', 'TXA prior to incision and 1-g intraoperative topical TXA', 'TXA', '1-g intravenous (IV) TXA']","['postoperative hemoglobin reduction', 'calculated blood loss', 'transfusion rates', 'hemoglobin reduction', 'venous thromboembolism', 'hemoglobin']","[{'cui': 'C0186202', 'cui_str': 'Revision of total hip replacement'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}]",175.0,0.117843,"No significant differences were found between TXA regimens when evaluating reduction in hemoglobin (3.4 g/dL for the single-dose IV group, 3.6 g/dL for the double-dose IV group, 3.5 g/dL for the combined IV and topical group, and 3.4 g/dL for the multidose oral group; p = 0.95), calculated blood loss (p = 0.90), or transfusion rates (14% for the single-dose IV group, 18% for the double-dose IV group, 17% for the combined group, and 17% for the multidose oral group; p = 0.96).","[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Sershon', 'Affiliation': 'Department of Orthopedic Surgery, Anderson Orthopaedic Research Institute, Alexandria, Virginia.'}, {'ForeName': 'Yale A', 'Initials': 'YA', 'LastName': 'Fillingham', 'Affiliation': 'Department of Orthopedic Surgery, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Abdel', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Arthur L', 'Initials': 'AL', 'LastName': 'Malkani', 'Affiliation': 'Department of Orthopedic Surgery, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Schwarzkopf', 'Affiliation': 'Department of Orthopedic Surgery, New York University, New York, NY.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Padgett', 'Affiliation': 'Department of Orthopedic Surgery, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Vail', 'Affiliation': 'Department of Orthopedic Surgery, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Nam', 'Affiliation': 'Department of Orthopedic Surgery, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Nahhas', 'Affiliation': 'Department of Orthopedic Surgery, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Culvern', 'Affiliation': 'Department of Orthopedic Surgery, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Della Valle', 'Affiliation': 'Department of Orthopedic Surgery, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.20.00010'] 982,33148972,Kinetics of Muscle Carnosine Decay after β-Alanine Supplementation: A 16-wk Washout Study.,"PURPOSE This study aimed to describe the kinetics of carnosine washout in human skeletal muscle over 16 wk. METHODS Carnosine washout kinetics were studied in 15 young, physically active omnivorous men randomly assigned to take 6.4 g·d-1 of β-alanine (n = 11) or placebo (n = 4) for 8 wk. Muscle carnosine content (M-Carn) was determined before (PRE), immediately after (POST), and 4, 8, 12, and 16 wk after supplementation. High-intensity exercise tests were performed at these same time points. Linear and exponential models were fitted to the washout data, and the leave-one-out method was used to select the model with the best fit for M-Carn decay data. Repeated-measures correlation analysis was used to assess the association between changes in M-Carn and changes in performance. RESULTS M-Carn increased from PRE to POST in the β-alanine group only (+91.1% ± 29.1%; placebo, +0.04% ± 10.1%; P < 0.0001). M-Carn started to decrease after cessation of β-alanine supplementation and continued to decrease until week 16 (POST4, +59% ± 40%; POST8, +35% ± 39%; POST12, +18% ± 32%; POST16, -3% ± 24% of PRE M-Carn). From week 12 onward, M-Carn was no longer statistically different from PRE. Both linear and exponential models displayed very similar fit and could be used to describe carnosine washout, although the linear model presented a slightly better fit. The decay in M-Carn was mirrored by a similar decay in high-intensity exercise tolerance; M-Carn was moderately and significantly correlated with total mechanical work done (r = 0.505; P = 0.032) and time to exhaustion (r = 0.72; P < 0.001). CONCLUSIONS Carnosine washout takes 12-16 wk to complete, and it can be described either by linear or exponential curves. Changes in M-Carn seem to be mirrored by changes in high-intensity exercise tolerance. This information can be used to optimize β-alanine supplementation strategies.",2021,"From week 12 onwards, M-Carn was no longer statistically different from PRE.","['fifteen young, physically-active omnivorous men randomly assigned to take 6.4 g·d of']","['placebo', 'β-alanine Supplementation', 'β-alanine']","['decay in M-Carn', 'M-Carn increased from PRE to POST', 'Muscle carnosine content (M-Carn']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4517822', 'cui_str': '6.4'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0007267', 'cui_str': 'Carnosine'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}]",15.0,0.0251349,"From week 12 onwards, M-Carn was no longer statistically different from PRE.","[{'ForeName': 'Guilherme Carvalho', 'Initials': 'GC', 'LastName': 'Yamaguchi', 'Affiliation': 'Applied Physiology and Nutrition Research Group, School of Physical Education and Sport, Rheumatology Division, Faculdade de Medicina FMUSP, Universidade de São Paulo, São Paulo, SP, BRAZIL.'}, {'ForeName': 'Kleiner', 'Initials': 'K', 'LastName': 'Nemezio', 'Affiliation': 'Applied Physiology and Nutrition Research Group, School of Physical Education and Sport, Rheumatology Division, Faculdade de Medicina FMUSP, Universidade de São Paulo, São Paulo, SP, BRAZIL.'}, {'ForeName': 'Mariane Leichsenring', 'Initials': 'ML', 'LastName': 'Schulz', 'Affiliation': 'Departamento de Bioquímica, Instituto de Química, Universidade de São Paulo, São Paulo, SP, BRAZIL.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Natali', 'Affiliation': 'Applied Physiology and Nutrition Research Group, School of Physical Education and Sport, Rheumatology Division, Faculdade de Medicina FMUSP, Universidade de São Paulo, São Paulo, SP, BRAZIL.'}, {'ForeName': 'Jonatas Eduardo', 'Initials': 'JE', 'LastName': 'Cesar', 'Affiliation': 'Departamento de Genética e Biologia Evolutiva, Instituto de Biociências, Universidade de São Paulo, SP, BRAZIL.'}, {'ForeName': 'Luiz Augusto', 'Initials': 'LA', 'LastName': 'Riani', 'Affiliation': 'Applied Physiology and Nutrition Research Group, School of Physical Education and Sport, Rheumatology Division, Faculdade de Medicina FMUSP, Universidade de São Paulo, São Paulo, SP, BRAZIL.'}, {'ForeName': 'Lívia DE Souza', 'Initials': 'LS', 'LastName': 'Gonçalves', 'Affiliation': 'Applied Physiology and Nutrition Research Group, School of Physical Education and Sport, Rheumatology Division, Faculdade de Medicina FMUSP, Universidade de São Paulo, São Paulo, SP, BRAZIL.'}, {'ForeName': 'Gabriella Berwig', 'Initials': 'GB', 'LastName': 'Möller', 'Affiliation': 'Applied Physiology and Nutrition Research Group, School of Physical Education and Sport, Rheumatology Division, Faculdade de Medicina FMUSP, Universidade de São Paulo, São Paulo, SP, BRAZIL.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Sale', 'Affiliation': 'Musculoskeletal Physiology Research Group, Sport, Health and Performance Enhancement Research Centre, Nottingham Trent University, Nottingham, UNITED KINGDOM.'}, {'ForeName': 'Marisa Helena Gennari', 'Initials': 'MHG', 'LastName': 'DE Medeiros', 'Affiliation': 'Departamento de Bioquímica, Instituto de Química, Universidade de São Paulo, São Paulo, SP, BRAZIL.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Gualano', 'Affiliation': 'Applied Physiology and Nutrition Research Group, School of Physical Education and Sport, Rheumatology Division, Faculdade de Medicina FMUSP, Universidade de São Paulo, São Paulo, SP, BRAZIL.'}, {'ForeName': 'Guilherme Giannini', 'Initials': 'GG', 'LastName': 'Artioli', 'Affiliation': 'Applied Physiology and Nutrition Research Group, School of Physical Education and Sport, Rheumatology Division, Faculdade de Medicina FMUSP, Universidade de São Paulo, São Paulo, SP, BRAZIL.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002559'] 983,33155562,"""Can patients learn how to reduce their shoulder dislocation?"" A one-year follow-up of the randomized clinical trial between the Boss-Holzach-Matter self-assisted technique and the Spaso method.","OBJECTIVE The aim of this study was to assess the effectiveness and reproducibility of self-assisted Boss-Holzach-Matter (BHM) technique compared with the Spaso (Sp) method for shoulder dislocation. METHODS We conducted a follow-up at 1 year from the randomization of 60 patients with shoulder dislocation enrolled in the study ""Teaching patients to reduce a shoulder dislocation."" Half of these patients had been taught the self-assisted technique, whereas the other half had been treated by a physician's manipulative maneuver for reduction. We surveyed all the enrolled patients to describe recurrence rates and reproducibility for both the techniques without supervision as well as the number of emergency visits. RESULTS In total, 52 patients (age range: 18-44 years) answered the survey from the 60 patients enrolled in the study. The total rate of recurrence was 38.5% (20 patients). For the Sp group, 4 of the 30 patients were lost. There were 9 recurrent patients (30%), and 7 were treated in the emergency department (ED). For the BHM group, 4 of the 30 patients were lost. There were 11 recurrent patients (37%), and 2 were treated in the ED. The difference in self-reduction rates and ED visits for both the groups was statistically significant (p=0.025). CONCLUSION Teaching the BHM technique to the patients is effective and reproducible without direct supervision. It can decrease the number of visits to the ED and is a valid option to teach the patients at risk of recurrence when not being able to get immediate help. LEVEL OF EVIDENCE Level I, Therapeutic study.",2020,"The difference in self-reduction rates and ED visits for both the groups was statistically significant (p=0.025). ","['60 patients with shoulder dislocation enrolled in the study ""Teaching patients to reduce a shoulder dislocation', '52 patients (age range: 18-44 years) answered the survey from the 60 patients enrolled in the study']","['self-assisted Boss-Holzach-Matter (BHM) technique compared with the Spaso (Sp', 'Holzach-Matter self-assisted technique and the Spaso method']","['self-reduction rates and ED visits', 'total rate of recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037005', 'cui_str': 'Dislocation of shoulder joint'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",60.0,0.0330681,"The difference in self-reduction rates and ED visits for both the groups was statistically significant (p=0.025). ","[{'ForeName': 'Francesc A', 'Initials': 'FA', 'LastName': 'Marcano-Fernández', 'Affiliation': ""Department of Orthopedics, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3Pti, Universitat Autònoma de Barcelona. Sabadell, Spain.""}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Fillat-Gomà', 'Affiliation': ""Department of Orthopedics, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3Pti, Universitat Autònoma de Barcelona. Sabadell, Spain.""}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Balaguer-Castro', 'Affiliation': ""Department of Orthopedics, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3Pti, Universitat Autònoma de Barcelona. Sabadell, Spain.""}, {'ForeName': 'Ona', 'Initials': 'O', 'LastName': 'Ràfols-Perramon', 'Affiliation': ""Department of Orthopedics, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3Pti, Universitat Autònoma de Barcelona. Sabadell, Spain.""}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Serrano-Sanz', 'Affiliation': ""Department of Orthopedics, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3Pti, Universitat Autònoma de Barcelona. Sabadell, Spain.""}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Torner', 'Affiliation': ""Department of Orthopedics, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3Pti, Universitat Autònoma de Barcelona. Sabadell, Spain.""}]",Acta orthopaedica et traumatologica turcica,['10.5152/j.aott.2020.19017'] 984,33155565,Assessing the role of hip arthrography in the treatment decision making for children with Legg-Calvé-Perthes disease.,"OBJECTIVE The aim of this study was to determine the role of hip arthrography in the treatment decision making for children with Legg-Calvé-Perthes disease (LCPD). METHODS A total of 47 consecutive children with LCPD (42 boys, 5 girls; mean age=7.5 years; range=6-10 years) who underwent operative treatment were included in the study. The patient demographics, physical examination findings (pain and hip range of motion [ROM]), standard anteroposterior and Löwenstein lateral hip radiographs, and hip arthrography data were retrospectively collected. The arthrographies were performed immediately before the surgery under general anesthesia. The patients were staged according to the Catterall and Herring classifications and examined in terms of head-at-risk signs before the study. Four sets of patient files were established based on the aforementioned data, with each child in a randomized and blinded order. Ten consultant pediatric orthopedic surgeons randomly assessed the patient files on 4 separate occasions (Set 1 vs Set 2 and Set 3 vs Set 4), with a minimum time interval of 4 weeks. In the first and second sets, the demographic and clinical information, including the age, gender, hip ROM, and hip radiographs, were presented. In the third and fourth sets, hip arthrography was presented in addition to the data from Set 1 and Set 2. The observers were instructed to choose the best treatment options. The percent agreement (PA) and Gwet's AC1 statistics were used to establish a relative level of agreement among the observers. RESULTS The mean intra-observer reliabilities ranged from fair to moderate after adding the hip arthrography data (Gwet's AC1 = 0.36 for Set 1 vs Set 2 and 0.42 for Set 3 vs Set 4). The mean PA was 56.6% (range = 29.8% to 78.7%) with a Gwet's AC1 value of 0.51 (range: 0.21 to 0.77) between Set 1 and Set 3 (moderate intra-observer reliability). The decision for the treatment strategy was changed in 43.4% of the patients. For inter-observer reliability, Gwet's AC1 was computed as 0.48 (moderate reliability). The correlation between the intra-observer reliability and stage progression was not significant (p>0.05) for any of the subgroups. Thus, there is a negative correlation with the disease progression. CONCLUSION Hip arthrography seems to have a significant role in the treatment decision making for children with LCPD, especially in the advanced stages of the disease. LEVEL OF EVIDENCE Level IV, Therapeutic study.",2020,The correlation between the intra-observer reliability and stage progression was not significant (p>0.05) for any of the subgroups.,"['47 consecutive children with LCPD (42 boys, 5 girls; mean age=7.5 years; range=6-10 years) who underwent operative treatment were included in the study', 'children with Legg-Calvé-Perthes disease', 'children with Legg-Calvé-Perthes disease (LCPD', 'children with LCPD']",['hip arthrography'],"['patient demographics, physical examination findings (pain and hip range of motion [ROM]), standard anteroposterior and Löwenstein lateral hip radiographs, and hip arthrography data', 'intra-observer reliability and stage progression', 'mean intra-observer reliabilities', 'mean PA']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023234', 'cui_str': 'Coxa plana'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0003885', 'cui_str': 'Arthrography'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0576002', 'cui_str': 'Hip joint - range of movement'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0003885', 'cui_str': 'Arthrography'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",47.0,0.0265941,The correlation between the intra-observer reliability and stage progression was not significant (p>0.05) for any of the subgroups.,"[{'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Erkuş', 'Affiliation': 'Department of Orthopaedics and Traumatology, Tepecik Training and Research Hospital İzmir, Turkey.'}, {'ForeName': 'Önder', 'Initials': 'Ö', 'LastName': 'Kalenderer', 'Affiliation': 'Department of Orthopaedics and Traumatology, Tepecik Training and Research Hospital İzmir, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Turgut', 'Affiliation': 'Department of Orthopaedics and Traumatology, Tepecik Training and Research Hospital İzmir, Turkey.'}, {'ForeName': 'Tayfun', 'Initials': 'T', 'LastName': 'Bacaksız', 'Affiliation': 'Department of Orthopaedics and Traumatology, Akçakale State Hospital Şanlıurfa, Turkey.'}, {'ForeName': 'Özkan', 'Initials': 'Ö', 'LastName': 'Köse', 'Affiliation': 'Department of Orthopaedics and Traumatology, Antalya Training and Research Hospital Antalya, Turkey.'}, {'ForeName': 'Kıvanç', 'Initials': 'K', 'LastName': 'Yüksel', 'Affiliation': 'Department of Data Management and Biostatistics, Ege University, School of Medicine ARGEFAR, İzmir, Turkey.'}]",Acta orthopaedica et traumatologica turcica,['10.5152/j.aott.2020.19075'] 985,33164945,Continuous Subcutaneous Levodopa Delivery for Parkinson's Disease: A Randomized Study.,"BACKGROUND ND0612 is a continuous, subcutaneous levodopa/carbidopa delivery system in development for patients with Parkinson's disease (PD) experiencing motor fluctuationsObjective:Evaluate the efficacy and safety of two ND0612 dosing regimens in patients with PD. METHODS This was a 28-day open-label study (NCT02577523) in PD patients with ≥2.5 hours/day of OFF time despite optimized treatment. Patients were randomized to treatment with either a 24-hour infusion (levodopa/carbidopa dose of 720/90 mg) or a 14-hour 'waking-day' infusion (levodopa/carbidopa dose of 538/68 mg plus a morning oral dose of 150/15 mg). Supplemental oral doses of levodopa were permitted for patients in both groups if required. In-clinic assessments of OFF time (primary endpoint) and ON time with or without dyskinesia were determined by a blinded rater over 8 hours (normalized to 16 hours). RESULTS A total of 38 patients were randomized and 33 (87%) completed the study. Compared to baseline, OFF time for the overall population was reduced by a least squares (LS) mean[95% CI] of 2.0[- 3.3, - 0.7] hours (p = 0.003). ON time with no/mild dyskinesia (no troublesome dyskinesia) was increased from baseline by a LS mean of 3.3[2.0, 4.6] hours (p < 0.0001), and ON time with moderate/severe dyskinesia was reduced by a LS mean of 1.2[- 1.8, - 0.5] hours (p≤0.001). Reduction in OFF time was larger in the 24-hour group (- 2.8[- 4.6, - 0.9] hours; p = 0.004) than in the 14-hour group (- 1.3[- 3.1, 0.5] hours; p = 0.16). Complete resolution of OFF time was observed in 42% (n = 8) of patients in the 24-hour group. Infusion site reactions were the most common adverse event. CONCLUSION This study demonstrates the feasibility and safety of continuous subcutaneous delivery of levodopa as a treatment for PD and provides preliminary evidence of efficacy.",2021,Complete resolution of OFF time was observed in 42% (n = 8) of patients in the 24-hour group.,"[""Parkinson's Disease"", 'patients with PD', 'PD patients with ≥2.5 hours/day of OFF time despite optimized treatment', ""patients with Parkinson's disease (PD) experiencing motor fluctuationsObjective"", '38 patients were randomized and 33 (87% ) completed the study']","['levodopa', 'levodopa/carbidopa delivery system', ""24-hour infusion (levodopa/carbidopa dose of 720/90\u200amg) or a 14-hour 'waking-day' infusion (levodopa/carbidopa""]","['Complete resolution of OFF time', 'OFF time (primary endpoint) and ON time with or without dyskinesia', 'ON time with no/mild dyskinesia', 'efficacy and safety', 'Reduction in OFF time', 'OFF time', 'ON time with moderate/severe dyskinesia']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0556974', 'cui_str': 'hours/day'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0006982', 'cui_str': 'Carbidopa'}, {'cui': 'C0449914', 'cui_str': 'Delivery system'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",38.0,0.079001,Complete resolution of OFF time was observed in 42% (n = 8) of patients in the 24-hour group.,"[{'ForeName': 'C Warren', 'Initials': 'CW', 'LastName': 'Olanow', 'Affiliation': 'Clintrex Research Corp, Sarasota, FL, USA.'}, {'ForeName': 'Alberto J', 'Initials': 'AJ', 'LastName': 'Espay', 'Affiliation': ""James J and Joan A Gardner Center for Parkinson's disease and Movement Disorders, University of Cincinnati, Cincinnati, OH, USA.""}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Stocchi', 'Affiliation': 'University and Institute for Research and Medical Care IRCCS San Raffaele, Roma, Italy.'}, {'ForeName': 'Aaron L', 'Initials': 'AL', 'LastName': 'Ellenbogen', 'Affiliation': 'Michigan Institute for Neurological Disorders, Farmington Hills, MI, USA.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Leinonen', 'Affiliation': 'Clintrex Research Corp, Sarasota, FL, USA.'}, {'ForeName': 'Liat', 'Initials': 'L', 'LastName': 'Adar', 'Affiliation': 'NeuroDerm Ltd., Rehovot, Israel.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Case', 'Affiliation': 'NeuroDerm Ltd., Rehovot, Israel.'}, {'ForeName': 'Shir Fuchs', 'Initials': 'SF', 'LastName': 'Orenbach', 'Affiliation': 'NeuroDerm Ltd., Rehovot, Israel.'}, {'ForeName': 'Tami', 'Initials': 'T', 'LastName': 'Yardeni', 'Affiliation': 'NeuroDerm Ltd., Rehovot, Israel.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Oren', 'Affiliation': 'NeuroDerm Ltd., Rehovot, Israel.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Poewe', 'Affiliation': 'Department of Neurology, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of Parkinson's disease,['10.3233/JPD-202285'] 986,33160857,Repeatability of training-induced skeletal muscle adaptations in active young males.,"OBJECTIVES Measurements of protein content, enzymatic activity, and/or capillarization are frequently utilized as markers of skeletal muscle adaptation following exercise training. Whether changes in these markers of muscle adaptation are repeatable when individuals are repeatedly exposed to the same training stimulus is unknown. The purpose of this study was to test the repeatability of skeletal muscle adaptations to two identical training periods. METHODS Ten active young males (age: 22 ± 2 years; VO 2 max: 57 ± 7 ml/kg/min) were exposed to two identical four-week periods of supervised high-intensity interval running (4 × 4 min at 90-95% of HRmax interspersed with 3-min at 70-75% HRmax) separated by a 3-month wash-out period. Vastus lateralis biopsies were obtained before and after each training period for the measurement of protein content, enzyme activity, and capillary density. RESULTS Training-induced changes in citrate synthase (CS) maximal activity, protein content (PGC-1α, OXPHOS, and LDH-A), and capillary density were not repeatable within individuals (r = -0.52-0.15; ICCs: -0.42-0.04; CVs: 11-67%). Several OXPHOS complex subunits also demonstrated dissimilar group-level adaptations (period × time interaction effects, p < 0.05) with large differences (η p 2  > 0.4) between training periods. A large (η p 2  = 0.65) increase in capillary density was apparent irrespective of training period (main effect of time, p = 0.05). CONCLUSIONS An individual (or a group of individuals) may exhibit dissimilar skeletal muscle adaptations when re-exposed to the same training stimulus. Our findings challenge the utility of classifying of individuals as high/low responders using measurements of mitochondrial protein content, CS activity and/or capillary density following a single training period.",2021,"A large (η p 2  = 0.65) increase in capillary density was apparent irrespective of training period (main effect of time, p = 0.05). ","['Ten active young males (age: 22\u202f±\u202f2 years; VO 2 max: 57\u202f±\u202f7\u202fml/kg/min', 'active young males']",['supervised high-intensity interval running (4\u202f×\u202f4\u202fmin at 90-95% of HRmax interspersed with 3-min at 70-75% HRmax'],"['capillary density', 'mitochondrial protein content, CS activity and/or capillary density', 'citrate synthase (CS) maximal activity, protein content (PGC-1α, OXPHOS, and LDH-A), and capillary density']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0006901', 'cui_str': 'Structure of capillary blood vessel (organ)'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0949610', 'cui_str': 'Mitochondrial Protein'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0008855', 'cui_str': 'Citrate(si)-synthase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0024395', 'cui_str': 'Lactic acid dehydrogenase isoenzyme 5'}]",10.0,0.0368562,"A large (η p 2  = 0.65) increase in capillary density was apparent irrespective of training period (main effect of time, p = 0.05). ","[{'ForeName': 'Hashim', 'Initials': 'H', 'LastName': 'Islam', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, Canada.""}, {'ForeName': 'Jacob T', 'Initials': 'JT', 'LastName': 'Bonafiglia', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, Canada.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Del Giudice', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, Canada.""}, {'ForeName': 'Rishiga', 'Initials': 'R', 'LastName': 'Pathmarajan', 'Affiliation': 'Department of Kinesiology, University of Waterloo, Canada.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Simpson', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, Canada.""}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Quadrilatero', 'Affiliation': 'Department of Kinesiology, University of Waterloo, Canada.'}, {'ForeName': 'Brendon J', 'Initials': 'BJ', 'LastName': 'Gurd', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, Canada. Electronic address: gurdb@queensu.ca.""}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.10.016'] 987,33169175,Comparison of 5-year postoperative results between standard-length stems and short stems in one-stage bilateral total hip arthroplasty: a randomized controlled trial.,"PURPOSE Short stems have recently become popular in total hip arthroplasty. Previous studies aimed at elucidating the efficacy of short stems did not eliminate the influence of other factors aside from stem length. This study aimed to evaluate the usefulness of short stems compared with that of standard-length stems that have the same proximal morphology, surface coating, and material. METHODS This was a prospective randomized study comparing 5-year midterm outcomes in 29 patients who underwent one-stage bilateral total hip arthroplasty with short and standard-length stems inserted in each of the two femurs. Clinical, radiographical, and dual-energy X-ray absorptiometry outcomes were compared. RESULTS No significant differences were found in perioperative and radiographic characteristics (femoral neck anteversion, flare index, operation sequence, operation side, operation time, stem anteversion, and stem alignment). The number of joints with complications, appearance of radiopaque lines around the stems, or bone mineral density changed in stem regions 5 years postoperatively. However, greater micromotion of the stem was seen on the side of the short stem. Satisfactory improvement in hip function was seen on both sides. CONCLUSION Based on the 5-year midterm outcomes, both stems obtained satisfactory clinical outcomes despite the greater micromotion with short stems. Both stems attained bone ingrowth fixation. Moreover, the stems were not significantly different in terms of stress shielding; however, further long-term studies (> 5 years) are required to validate our findings related to stress shielding.",2021,"No significant differences were found in perioperative and radiographic characteristics (femoral neck anteversion, flare index, operation sequence, operation side, operation time, stem anteversion, and stem alignment).","['one-stage bilateral total hip arthroplasty', '29 patients who underwent one-stage bilateral total hip arthroplasty with short and standard-length stems inserted in each of the two femurs', 'total hip arthroplasty']",['standard-length stems and short stems'],"['Clinical, radiographical, and dual-energy X-ray absorptiometry outcomes', 'number of joints with complications, appearance of radiopaque lines around the stems, or bone mineral density', 'perioperative and radiographic characteristics (femoral neck anteversion, flare index, operation sequence, operation side, operation time, stem anteversion, and stem alignment', 'hip function']","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449813', 'cui_str': 'Number of joints'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0333053', 'cui_str': 'Anteversion'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",29.0,0.0259312,"No significant differences were found in perioperative and radiographic characteristics (femoral neck anteversion, flare index, operation sequence, operation side, operation time, stem anteversion, and stem alignment).","[{'ForeName': 'Masanobu', 'Initials': 'M', 'LastName': 'Hirao', 'Affiliation': 'Department of Orthopaedic Surgery, Medical Hospital of Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan.'}, {'ForeName': 'Kazumasa', 'Initials': 'K', 'LastName': 'Miyatake', 'Affiliation': 'Department of Orthopaedic Surgery, Medical Hospital of Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Koga', 'Affiliation': 'Department of Orthopaedic Surgery, Medical Hospital of Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan.'}, {'ForeName': 'Ryohei', 'Initials': 'R', 'LastName': 'Takada', 'Affiliation': 'Department of Orthopaedic Surgery, Medical Hospital of Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan.'}, {'ForeName': 'Gaku', 'Initials': 'G', 'LastName': 'Koyano', 'Affiliation': 'Department of Orthopaedic Surgery, Medical Hospital of Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Okawa', 'Affiliation': 'Department of Orthopaedic Surgery, Medical Hospital of Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Jinno', 'Affiliation': 'Department of Orthopaedic Surgery, Medical Hospital of Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan. jinnot@dokkyomed.ac.jp.'}]",European journal of orthopaedic surgery & traumatology : orthopedie traumatologie,['10.1007/s00590-020-02828-7'] 988,33174673,"Clinical effectiveness of metacognitive training as a transdiagnostic program in routine clinical settings: A prospective, multicenter, single-group study.","AIM To evaluate the clinical effectiveness of metacognitive training (MCT) as a transdiagnostic program, on a diverse population with mental disorders in routine Japanese day-care settings. METHODS This study employed a prospective, multicenter, single-group pre-post design. Participants diagnosed with various mental disorders received 10 MCT group sessions. We set transdiagnostic outcomes to assess quality of life, global functioning, cognitive insight, and depressive symptoms. At the end of the MCT, we also evaluated participants' satisfaction with treatment. Assessments were conducted at baseline (Pre), Week 5 (Mid), Week 10 (Post), and Week 14 (follow-up: FU). RESULTS Thirty-four participants enrolled in the study and received MCT (schizophrenia = 22, non-schizophrenia = 12). Intent-to-treat analyses revealed significant improvements in quality of life/global functioning during the intervention period, and further improvements were observed during the follow-up (all p < .05). The Pre-FU treatment effect sizes for quality of life and global functioning were small (Hedge's g = 0.44 and 0.47, respectively). Significant improvements were also found in depressive symptoms during both the intervention and follow-up periods (all p < .05), but not in cognitive insight. Overall, participants were highly satisfied with the MCT content and format. Scores on almost all outcomes (except for depression) at each assessment point were not significantly different between the schizophrenic and non-schizophrenic sub-groups. CONCLUSIONS Despite several limitations, mainly due to small sample size and having no control conditions, our results suggest that MCT for a diverse population with mental disorders is a potentially effective approach in improving quality of life/global functioning and other clinical outcomes in routine day-care settings.",2021,"Significant improvements were also found in depressive symptoms during both the intervention and follow-up periods (all p < .05), but not in cognitive insight.","['Participants diagnosed with various mental disorders', 'diverse population with mental disorders in routine Japanese day-care settings', 'routine clinical settings', 'Thirty-four participants enrolled in the study and received MCT (schizophrenia = 22, non-schizophrenia = 12']","['metacognitive training (MCT', 'MCT', 'metacognitive training']","['quality of life and global functioning', 'depressive symptoms', 'quality of life/global functioning', 'quality of life, global functioning, cognitive insight, and depressive symptoms']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0011017', 'cui_str': 'Day Care'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0233820', 'cui_str': 'Insight'}]",34.0,0.0532152,"Significant improvements were also found in depressive symptoms during both the intervention and follow-up periods (all p < .05), but not in cognitive insight.","[{'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Tanoue', 'Affiliation': 'School of Nursing, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Yoshinaga', 'Affiliation': 'School of Nursing, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan.'}, {'ForeName': 'Yuta', 'Initials': 'Y', 'LastName': 'Hayashi', 'Affiliation': 'Graduate School of Medicine and Veterinary Medicine, University of Miyazaki, Miyazaki, Japan.'}, {'ForeName': 'Ryotaro', 'Initials': 'R', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Clinical Psychology, Taisho University, Tokyo, Japan.'}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Ishigaki', 'Affiliation': 'Graduate School of Arts and Sciences, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Ishida', 'Affiliation': 'Division of Psychiatry, Department of Clinical Neuroscience, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan.'}]",Japan journal of nursing science : JJNS,['10.1111/jjns.12389'] 989,33171964,"The Effects of Non-Nutritive Artificial Sweeteners, Aspartame and Sucralose, on the Gut Microbiome in Healthy Adults: Secondary Outcomes of a Randomized Double-Blinded Crossover Clinical Trial.","Non-nutritive artificial sweeteners (NNSs) may have the ability to change the gut microbiota, which could potentially alter glucose metabolism. This study aimed to determine the effect of sucralose and aspartame consumption on gut microbiota composition using realistic doses of NNSs. Seventeen healthy participants between the ages of 18 and 45 years who had a body mass index (BMI) of 20-25 were selected. They undertook two 14-day treatment periods separated by a four-week washout period. The sweeteners consumed by each participant consisted of a standardized dose of 14% (0.425 g) of the acceptable daily intake (ADI) for aspartame and 20% (0.136 g) of the ADI for sucralose. Faecal samples collected before and after treatments were analysed for microbiome and short-chain fatty acids (SCFAs). There were no differences in the median relative proportions of the most abundant bacterial taxa (family and genus) before and after treatments with both NNSs. The microbiota community structure also did not show any obvious differences. There were no differences in faecal SCFAs following the consumption of the NNSs. These findings suggest that daily repeated consumption of pure aspartame or sucralose in doses reflective of typical high consumption have minimal effect on gut microbiota composition or SCFA production.",2020,There were no differences in the median relative proportions of the most abundant bacterial taxa (family and genus) before and after treatments with both NNSs.,"['Healthy Adults', 'Seventeen healthy participants between the ages of 18 and 45 years who had a body mass index (BMI) of 20-25 were selected']","['pure aspartame or sucralose', 'sucralose and aspartame consumption', 'Nutritive Artificial Sweeteners, Aspartame and Sucralose']","['faecal SCFAs', 'gut microbiota composition or SCFA production']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0003999', 'cui_str': 'Aspartame'}, {'cui': 'C0077046', 'cui_str': 'sucralose'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C3658237', 'cui_str': 'Artificial Sweeteners, Nutritive'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",17.0,0.152239,There were no differences in the median relative proportions of the most abundant bacterial taxa (family and genus) before and after treatments with both NNSs.,"[{'ForeName': 'Samar Y', 'Initials': 'SY', 'LastName': 'Ahmad', 'Affiliation': 'Richardson Centre for Functional Foods and Nutraceuticals, Department of Human Nutritional Sciences, University of Manitoba, 196 Innovation Drive, Winnipeg, MB R3T 2E1, Canada.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Friel', 'Affiliation': 'Richardson Centre for Functional Foods and Nutraceuticals, Department of Human Nutritional Sciences, University of Manitoba, 196 Innovation Drive, Winnipeg, MB R3T 2E1, Canada.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Mackay', 'Affiliation': 'Richardson Centre for Functional Foods and Nutraceuticals, Department of Human Nutritional Sciences, University of Manitoba, 196 Innovation Drive, Winnipeg, MB R3T 2E1, Canada.'}]",Nutrients,['10.3390/nu12113408'] 990,33175600,"Safety, reactogenicity, and immunogenicity of a 12-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine in healthy toddlers: results from a phase I, randomized trial.","As a stepping stone toward evaluation in infants, the safety and immunogenicity of an investigational 12-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (12vPHiD-CV) was assessed in toddlers. 12vPHiD-CV contains CRM 197 -conjugated capsular polysaccharides of serotypes 6A and 19A in addition to capsular polysaccharides of the 10 serotypes in PHiD-CV. In this phase I, double-blind, multicenter study (NCT01485406) conducted in Germany, 61 healthy toddlers aged 12-23 months previously primed with three PHiD-CV doses were randomized (1:1) to receive one dose of 12vPHiD-CV or PHiD-CV. Safety and reactogenicity of 12vPHiD-CV were assessed in terms of occurrence of grade 3 vaccination-related solicited and unsolicited adverse events (AEs) and vaccination-related serious AEs. Immune responses were evaluated 1 month post-vaccination. Grade 3 solicited local AEs (all considered vaccination-related) were reported for two (6.5%, redness) and three (9.7%, swelling) toddlers in the 12vPHiD-CV group and one (3.4%, swelling) in the PHiD-CV group. Grade 3 vaccination-related solicited general AEs were only reported in the PHiD-CV group. No grade 3 unsolicited or serious AEs were reported. For PHiD-CV serotypes, 100% of toddlers in both groups had antibody concentrations ≥0.2 µg/mL 1 month post-vaccination, and antibody geometric mean concentrations increased from pre-boosting. For serotypes 6A and 19A, antibody responses tended to be higher in the 12vPHiD-CV than the PHiD-CV group. A single dose of 12vPHiD-CV administered in toddlers was well tolerated and no safety concerns were identified. Immune responses were comparable to those induced by PHiD-CV when administered in toddlers previously primed with three doses of PHiD-CV.",2021,Immune responses were comparable to those induced by PHiD-CV when administered in toddlers previously primed with three doses of PHiD-CV.,"['61 healthy toddlers aged 12-23\xa0months previously primed with three PHiD-CV doses', 'healthy toddlers', 'toddlers']","['12-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine', '12vPHiD-CV or PHiD-CV', '12vPHiD-CV']","['tolerated and no safety concerns', 'antibody geometric mean concentrations', 'Safety, reactogenicity, and immunogenicity', 'Safety and reactogenicity of 12vPHiD-CV', 'grade 3 unsolicited or serious AEs', 'Grade 3 solicited local AEs', 'occurrence of grade 3 vaccination-related solicited and unsolicited adverse events (AEs) and vaccination-related serious AEs', 'Immune responses', 'safety and immunogenicity']","[{'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C1864445', 'cui_str': 'Histiocytosis-lymphadenopathy plus syndrome'}]","[{'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C0138826', 'cui_str': 'glpQ protein, Haemophilus influenzae'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C1864445', 'cui_str': 'Histiocytosis-lymphadenopathy plus syndrome'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}]",61.0,0.191257,Immune responses were comparable to those induced by PHiD-CV when administered in toddlers previously primed with three doses of PHiD-CV.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horn', 'Affiliation': 'Pediatric Office, Schönau Am Königssee, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Behre', 'Affiliation': 'Private Practice, Kehl, Germany.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Traskine', 'Affiliation': 'HPV, Hepatitis and Pneumococcal Vaccines, Clinical R&D, GSK, Wavre, Belgium.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Dobbelaere', 'Affiliation': 'HPV, Hepatitis and Pneumococcal Vaccines, Clinical R&D, GSK, Wavre, Belgium.'}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Borys', 'Affiliation': 'HPV, Hepatitis and Pneumococcal Vaccines, Clinical R&D, GSK, Wavre, Belgium.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2020.1810493'] 991,33176942,"Abuse liability assessment of the JUUL system in four flavors relative to combustible cigarette, nicotine gum and a comparator electronic nicotine delivery system among adult smokers.","BACKGROUND The abuse liability of the JUUL System (JS) in four flavors were evaluated compared to combustible cigarettes, nicotine gum, and a comparator electronic nicotine delivery system (ENDS) with pharmacokinetics (PK) and subjective effects. METHODS Adult smokers (N = 66; 50.0 % female; mean age = 41.1; 63.6 % white) completed a 7-arm within-subjects cross-over product-use study while confined to a clinical laboratory. Participants used JS in four flavors (Virginia Tobacco, Mango, Mint, Creme, [5.0 % nicotine; 59 mg/mL]), their usual brand (UB) cigarette, a comparator ENDS (VUSE Solo; 4.8 % nicotine, tobacco-flavor), and mint nicotine gum (4 mg) under controlled use conditions. After each product use, nicotine PK and subjective effects were assessed. RESULTS Maximum plasma nicotine levels (C max-BL ), rate of plasma nicotine rise, overall nicotine exposure (AUC 0-60-BL ), and subjective liking and satisfaction of JS were significantly lower than UB cigarettes. These parameters were generally greater for JS than nicotine gum; the comparator ENDS was somewhat lower but within the range of JS. Nicotine PK did not differ among the Mint, Mango, and Virginia Tobacco JS flavors. Mint and Mango were rated as more satisfying than Virginia Tobacco and Creme. CONCLUSIONS Controlled use of JS among adult smokers resulted in nicotine delivery, product liking, and satisfaction that were less than that of combustible cigarettes but generally greater than nicotine gum. These results support the conclusion that JS has lower abuse liability than combustible cigarettes, higher abuse liability than nicotine gum, and may provide sufficient nicotine delivery and satisfying effects to support substitution for combustible cigarettes among adult smokers.",2020,These parameters were generally greater for JS than nicotine gum; the comparator ENDS was somewhat lower but within the range of JS.,"['Adult smokers (N = 66; 50.0 % female; mean age = 41.1; 63.6 % white) completed a 7-arm within-subjects cross-over product-use study while confined to a clinical laboratory', 'adult smokers']","['Nicotine PK', 'usual brand (UB) cigarette, a comparator ENDS (VUSE Solo; 4.8 % nicotine, tobacco-flavor), and mint nicotine gum', 'JS']","['Maximum plasma nicotine levels (C max-BL ), rate of plasma nicotine rise, overall nicotine exposure (AUC 0-60-BL ), and subjective liking and satisfaction of JS']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C4517765', 'cui_str': '4.8'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C0452249', 'cui_str': 'Mint'}, {'cui': 'C0599654', 'cui_str': 'Nicotine Chewing Gum'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0202431', 'cui_str': 'Nicotine measurement'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",4.0,0.00946303,These parameters were generally greater for JS than nicotine gum; the comparator ENDS was somewhat lower but within the range of JS.,"[{'ForeName': 'Nicholas I', 'Initials': 'NI', 'LastName': 'Goldenson', 'Affiliation': 'Juul Labs, Inc., United States. Electronic address: nicholas.goldenson@juul.com.'}, {'ForeName': 'August R', 'Initials': 'AR', 'LastName': 'Buchhalter', 'Affiliation': 'PinneyAssociates, Inc., United States.'}, {'ForeName': 'Erik M', 'Initials': 'EM', 'LastName': 'Augustson', 'Affiliation': 'Juul Labs, Inc., United States.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Rubinstein', 'Affiliation': 'Juul Labs, Inc., United States.'}, {'ForeName': 'Jack E', 'Initials': 'JE', 'LastName': 'Henningfield', 'Affiliation': 'PinneyAssociates, Inc., United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108395'] 992,33180913,Pilot Trial of a Sleep-Promoting Intervention for Children With Type 1 Diabetes.,"OBJECTIVE To assess the feasibility and acceptability of an educational sleep-promoting intervention (Sleep Coach Jr.) for school-aged children (ages 5-9) with type 1 diabetes (T1D) and their parents. METHODS Parents and children (N = 39 dyads, mean child age = 8 years, 64% girls,) were randomized to either the Sleep Coach Jr. intervention, consisting of educational materials and three individual phone calls (N = 20), or the Standard Care condition (N = 19). Data were collected at enrollment and 3 months later. Children and parents wore actigraphy devices to obtain an objective measure of sleep characteristics, and parents completed questionnaire measures of sleep quality and psychosocial outcomes. Clinical data (i.e., hemoglobin A1c, glucose data) were obtained from children's medical records. RESULTS Feasibility and acceptability of the study were demonstrated to be high; all three sessions were completed by 80% of parents randomized to the Sleep Coach Jr. intervention, and 90% of parents completed follow-up data at 3 months. Parents reported high levels of satisfaction with the study and identified barriers to participation. No changes were observed in children's sleep or diabetes outcomes, but parental sleep quality and well-being improved. CONCLUSIONS A brief, behavioral sleep-promoting intervention is feasible and acceptable for school-aged children with T1D and their parents. A larger trial is needed to evaluate efficacy of the intervention.",2021,"RESULTS Feasibility and acceptability of the study were demonstrated to be high; all three sessions were completed by 80% of parents randomized to the Sleep Coach Jr. intervention, and 90% of parents completed follow-up data at 3 months.","['school-aged children (ages 5-9) with type 1 diabetes (T1D) and their parents', '39 dyads, mean child age ', 'Children With Type 1 Diabetes', 'school-aged children with T1D and their parents', 'Parents and children (N\u2009']","['Sleep Coach Jr. intervention, consisting of educational materials and three individual phone calls (N\u2009=\u200920), or the Standard Care condition', 'behavioral sleep-promoting intervention', 'Sleep-Promoting Intervention', 'educational sleep-promoting intervention (Sleep Coach Jr']","[""children's sleep or diabetes outcomes"", 'feasibility and acceptability', 'sleep quality and psychosocial outcomes', 'parental sleep quality and well-being improved']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",,0.0323601,"RESULTS Feasibility and acceptability of the study were demonstrated to be high; all three sessions were completed by 80% of parents randomized to the Sleep Coach Jr. intervention, and 90% of parents completed follow-up data at 3 months.","[{'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Jaser', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Bergner', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center.'}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Hamburger', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center.'}, {'ForeName': 'Shivani', 'Initials': 'S', 'LastName': 'Bhatia', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Lyttle', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center.'}, {'ForeName': 'Grace E', 'Initials': 'GE', 'LastName': 'Bell', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center.'}, {'ForeName': 'J Christopher', 'Initials': 'JC', 'LastName': 'Slaughter', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Malow', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center.'}, {'ForeName': 'Jill H', 'Initials': 'JH', 'LastName': 'Simmons', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center.'}]",Journal of pediatric psychology,['10.1093/jpepsy/jsaa105'] 993,33181890,Long-term safety and tolerability of adjunctive eslicarbazepine acetate in children with focal seizures.,"OBJECTIVE The objective of this study was to evaluate long-term safety and tolerability outcomes in two open-label extension (OLE) studies of adjunctive eslicarbazepine acetate (ESL) in children with focal seizures. METHODS Safety data from patients aged 4-17 years in OLEs of Studies 2093-208 and -305 were pooled and analyzed. Studies 208 and 305 were randomized, double-blind, placebo-controlled studies of adjunctive treatment with ESL in children with focal seizures refractory to treatment with 1-2 antiseizure drugs; patients could continue into uncontrolled OLEs (up to 5 years total duration). The OLEs evaluated the safety and tolerability of ESL (10-30 mg/kg/day; maximum 1200 mg/day). RESULTS The 1-year OLE and post-1-year OLE safety populations comprised 337 and 177 ESL-treated patients, respectively. The overall incidence of treatment-emergent adverse events (TEAEs) with ESL was 64.1% during the 1-year OLE and 52.5% during the post-1-year OLE. Nasopharyngitis, partial seizures, vomiting, pyrexia, headache, somnolence, and respiratory tract infection were the most frequently reported TEAEs during the 1-year OLE. The overall incidence of serious adverse events (AEs) was 8.9% during the 1-year OLE and 10.2% during the post-1-year OLE. Partial seizures (1.2%) and pneumonia (1.2%) were the most frequently reported serious AEs during the 1-year OLE. The overall incidence of TEAEs leading to discontinuation was 4.2% during the 1-year OLE and 0.6% during the post-1-year OLE. Partial seizures (1.5%) was the most frequently reported TEAE leading to discontinuation during the 1-year OLE. CONCLUSIONS Overall, long-term treatment with ESL was generally well tolerated in pediatric patients aged 4-17 years with focal seizures. TEAEs were comparable to those observed in adults with no new events of concern.",2020,The overall incidence of treatment-emergent adverse events (TEAEs) with ESL was 64.1% during the 1-year OLE and 52.5% during the post-1-year OLE.,"['children with focal seizures', 'patients aged 4-17\u202fyears in OLEs of Studies 2093-208 and -305 were pooled and analyzed', 'pediatric patients aged 4-17\u202fyears with focal seizures', 'children with focal seizures refractory to treatment with 1-2 antiseizure drugs; patients could continue into uncontrolled OLEs (up to 5\u202fyears total duration']","['ESL', 'placebo', 'adjunctive eslicarbazepine acetate', 'adjunctive eslicarbazepine acetate (ESL']","['pneumonia', 'overall incidence of serious adverse events (AEs', 'Nasopharyngitis, partial seizures, vomiting, pyrexia, headache, somnolence, and respiratory tract infection', 'safety and tolerability', 'overall incidence of TEAEs leading to discontinuation', '1-year OLE and post-1-year OLE safety populations', 'Partial seizures', 'overall incidence of treatment-emergent adverse events (TEAEs) with ESL']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]","[{'cui': 'C2725262', 'cui_str': 'Eslicarbazepine acetate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C2725262', 'cui_str': 'Eslicarbazepine acetate'}]",2093.0,0.10413,The overall incidence of treatment-emergent adverse events (TEAEs) with ESL was 64.1% during the 1-year OLE and 52.5% during the post-1-year OLE.,"[{'ForeName': 'Raman', 'Initials': 'R', 'LastName': 'Sankar', 'Affiliation': ""David Geffen School of Medicine, UCLA Mattel Children's Hospital, Los Angeles, CA, USA. Electronic address: rsankar@ucla.edu.""}, {'ForeName': 'Fenella J', 'Initials': 'FJ', 'LastName': 'Kirkham', 'Affiliation': 'University Hospital Southampton, Southampton, UK; UCL Great Ormond Street Institute of Child Health, London, UK. Electronic address: fenella.kirkham@ucl.ac.uk.'}, {'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Holmes', 'Affiliation': 'College of Medicine, University of Vermont, Burlington, VT, USA. Electronic address: gregory.holmes@med.uvm.edu.'}, {'ForeName': 'J Eric', 'Initials': 'JE', 'LastName': 'Pina-Garza', 'Affiliation': ""Centennial Children's Hospital, Nashville, TN, USA. Electronic address: jesus.pinagarza@hcahealthcare.com.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wheless', 'Affiliation': ""UTHSC Pediatric Neurology, Le Bonheur Children's Hospital, Memphis, TN, USA. Electronic address: jwheless@uthsc.edu.""}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Gama', 'Affiliation': 'BIAL - Portela & Cª, S.A., Coronado (S. Romão e S. Mamede), Portugal. Electronic address: Helena.gama@bial.com.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Moreira', 'Affiliation': 'BIAL - Portela & Cª, S.A., Coronado (S. Romão e S. Mamede), Portugal. Electronic address: joana.moreira@bial.com.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cantu', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Fort Lee, NJ, USA. Electronic address: David.Cantu@sunovion.com.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Tosiello', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA. Electronic address: rtosiello@comcast.net.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Blum', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA. Electronic address: davideblum@gmail.com.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Grinnell', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA. Electronic address: todd.grinnell@sunovion.com.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107458'] 994,33181893,Long-term efficacy and safety of cannabidiol (CBD) in children with treatment-resistant epilepsy: Results from a state-based expanded access program.,"INTRODUCTION An intermediate-sized, multicenter, expanded-access study was opened in 2015 through the support of the State of Georgia. This study provided children with treatment-resistant epilepsy (TRE) access to plant-derived highly purified cannabidiol (CBD; Epidiolex® in the US; Epidyolex® in the EU; 100 mg/mL oral solution). These children had failed to achieve seizure freedom with available treatment options and were ineligible to participate in randomized controlled trials that only included patients with Lennox-Gastaut and Dravet syndromes. METHODS Cannabidiol safety, changes in seizure type, frequency, and seizure-free days were evaluated for children aged 1-18 years (at time of consent) as an adjunctive treatment for 36 months. The study consisted of a two-month baseline period, a titration period, treatment period, and optional titration period, which occurred after ≥26 weeks of treatment. Cannabidiol treatment was administered up to a targeted dose of 25 mg/kg/day, with an optional secondary treatment up to 50 mg/kg/day. Daily seizure type, seizure frequency, and seizure-free days were recorded in a Web-based diary, and changes in these outcomes were recorded and analyzed for the duration of the study. The occurrence of adverse events (AEs) was also recorded. RESULTS The median percentage change in seizures for 45 patients in Months 3, 6, 12, 18, 24, and 36 showed a statistically significant (p < 0.001) reduction in major seizures (ranging from 54 to 72% at various time points) and all seizures (61-70%) compared with baseline. A mean increase in seizure-free days per 28 days was >5 in all treatment periods after Month 2, and an average increase of 7.52 (p < 0.001) seizure-free days per 28 days was observed at the end of follow-up compared with baseline. All patients experienced ≥1 AE. Children who transitioned to the optional secondary treatment (high-dose group) reported more AEs before increasing their dose to >25.0 mg/kg/day compared with the low-dose group. However, the average rate of AEs was significantly lower after moving to a high-dose regimen (p = 0.004). Twelve children reported 20 serious AEs, none of which were considered related to CBD. CONCLUSIONS This study supports CBD as an adjunctive treatment for children with TRE. Treatment was well tolerated in doses up to 50 mg/kg/day. Patients who did not achieve desired results at a dose of ≤25.0 mg/kg/day reported more AEs when CBD dose increased to >25.0 mg/kg/day. Decreases in major seizure frequency and an increase in seizure-free days compared with baseline were reported during treatment. This supports the efficacy and tolerability of CBD for mixed seizure etiologies.",2020,"A mean increase in seizure-free days per 28 days was >5 in all treatment periods after Month 2, and an average increase of 7.52 (p < 0.001) seizure-free days per 28 days was observed at the end of follow-up compared with baseline.","['children with TRE', 'children aged 1-18\u202fyears (at time of consent) as an adjunctive treatment for 36\u202fmonths', 'children with treatment-resistant epilepsy', 'patients with Lennox-Gastaut and Dravet syndromes', 'children with treatment-resistant epilepsy (TRE']","['CBD', 'cannabidiol (CBD']","['median percentage change in seizures', 'major seizure frequency', 'seizure type, frequency, and seizure-free days', 'average rate of AEs', 'occurrence of adverse events (AEs', 'seizure-free days', 'Daily seizure type, seizure frequency, and seizure-free days', 'efficacy and tolerability', 'major seizures']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238111', 'cui_str': 'Lennox-Gastaut syndrome'}, {'cui': 'C0751122', 'cui_str': 'Severe myoclonic epilepsy in infancy'}]","[{'cui': 'C0006863', 'cui_str': 'Cannabidiol'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1299590', 'cui_str': 'Seizure free'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C1319808', 'cui_str': 'Daily seizures'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.153858,"A mean increase in seizure-free days per 28 days was >5 in all treatment periods after Month 2, and an average increase of 7.52 (p < 0.001) seizure-free days per 28 days was observed at the end of follow-up compared with baseline.","[{'ForeName': 'Yong D', 'Initials': 'YD', 'LastName': 'Park', 'Affiliation': 'Augusta University, Augusta, GA, United States. Electronic address: YPARK@augusta.edu.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Linder', 'Affiliation': 'Augusta University, Augusta, GA, United States. Electronic address: dlinder@augusta.edu.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Pope', 'Affiliation': 'Augusta University, Augusta, GA, United States. Electronic address: jampope@umd.edu.'}, {'ForeName': 'J Robert', 'Initials': 'JR', 'LastName': 'Flamini', 'Affiliation': 'Panda Neurology, Atlanta, GA, United States. Electronic address: rflamini@comcast.net.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Moretz', 'Affiliation': 'Memorial Health University Medical Center, Savannah, GA, United States.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Diamond', 'Affiliation': 'Augusta University, Augusta, GA, United States. Electronic address: midiamond@augusta.edu.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Long', 'Affiliation': 'Augusta University, Augusta, GA, United States. Electronic address: salong@augusta.edu.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107474'] 995,31768697,Population pharmacokinetic modeling of PF-06439535 (a bevacizumab biosimilar) and reference bevacizumab (Avastin ® ) in patients with advanced non-squamous non-small cell lung cancer.,"PURPOSE The objectives of this analysis were to characterize the population pharmacokinetics (PK) of PF-06439535 (a bevacizumab biosimilar) and reference bevacizumab (Avastin ® ) sourced from the European Union (bevacizumab-EU) in patients with advanced non-squamous non-small cell lung cancer (NSCLC), and to quantify the difference in PK parameters between the two drug products via covariate analysis. METHODS Pooled PF-06439535 and bevacizumab-EU serum concentration data from a comparative clinical efficacy and safety study (NCT02364999) in patients with NSCLC (N = 719) were analyzed using a non-linear mixed-effects modeling approach. Patients received PF-06439535 plus chemotherapy or bevacizumab-EU plus chemotherapy every 21 days for 4-6 cycles, followed by monotherapy with PF-06439535 or bevacizumab-EU. PF-06439535 or bevacizumab-EU was administered intravenously at a dose of 15 mg/kg. Effects of patient and disease covariates, as well as the drug product (PF-06439535 versus bevacizumab-EU), on PK were investigated. RESULTS Overall, 8632 serum bevacizumab concentrations from 351 patients in the PF-06439535 group and 354 patients in the bevacizumab-EU group were included in the analysis. A two-compartment model adequately described the combined data. Clearance (CL) and central volume of distribution (V 1 ) estimates were 0.0113 L/h and 2.99 L for a typical 71-kg female patient with NSCLC administered bevacizumab-EU. CL and V 1 increased with body weight and were higher in males than females even after accounting for differences in body weight. The 95% confidence intervals for the effect of drug product on CL and V 1 encompassed unity. CONCLUSIONS The population PK of PF-06439535 and bevacizumab-EU were well characterized by a two-compartment model. Covariate analysis did not reveal any appreciable differences between PK parameters for PF-06439535 and bevacizumab-EU in patients with NSCLC. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, NCT02364999.",2020,"Covariate analysis did not reveal any appreciable differences between PK parameters for PF-06439535 and bevacizumab-EU in patients with NSCLC. ","['patients with advanced non-squamous non-small cell lung cancer (NSCLC', 'patients with NSCLC', '71-kg female patient with NSCLC', '351 patients in the PF-06439535 group and 354 patients in the', 'patients with NSCLC (N\u2009=\u2009719', 'patients with advanced non-squamous non-small cell lung cancer']","['PF-06439535 (a bevacizumab biosimilar) and reference bevacizumab (Avastin ® ', 'PF-06439535 or bevacizumab-EU', 'European Union (bevacizumab-EU', 'bevacizumab-EU', 'drug product (PF-06439535 versus bevacizumab-EU', 'PF-06439535 plus chemotherapy or bevacizumab-EU plus chemotherapy', 'PF-06439535 and bevacizumab-EU']","['CL and V 1 increased with body weight', 'Clearance (CL) and central volume of distribution (V 1 ) estimates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4324656', 'cui_str': 'Non-squamous non-small cell lung cancer'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C1135130', 'cui_str': 'Avastin'}, {'cui': 'C0015179', 'cui_str': 'European Community'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",,0.142115,"Covariate analysis did not reveal any appreciable differences between PK parameters for PF-06439535 and bevacizumab-EU in patients with NSCLC. ","[{'ForeName': 'Cheryl S W', 'Initials': 'CSW', 'LastName': 'Li', 'Affiliation': 'Clinical Pharmacology/Pharmacometrics, Pfizer Global Product Development, Pfizer Inc., 300 Technology Square, Cambridge, MA, 02140, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Sweeney', 'Affiliation': 'Clinical Pharmacology/Pharmacometrics, Pfizer Global Product Development, Pfizer Inc., Eastern Point Road, Groton, CT, 06340, USA. kevin.sweeney@pfizer.com.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Cronenberger', 'Affiliation': 'Clinical Pharmacology/Pharmacometrics, Pfizer Global Product Development, Pfizer Inc., 500 Arcola Road, Collegeville, PA, 19426, USA.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-019-03946-8'] 996,33187948,Do perioperative antibiotics reduce complications of mandibular third molar removal? A double-blind randomized controlled clinical trial.,"OBJECTIVE The aim of this study was to compare the effects of different antibiotic prophylaxis regimens versus placebo in relation to possible postoperative complications derived from the surgical extraction of impacted lower third molars. STUDY DESIGN The final study sample of this double-blind randomized controlled trial comprised 92 Caucasian volunteers. Patients were assigned to 3 groups by using a randomization table. Group 1 (n = 30) received 750 mg oral amoxicillin both before and after the surgery; group 2 (n = 32) received the same oral dose after surgery alone; and group 3 (n = 30) received placebo both before and after surgery. Infectious complications, postoperative pain, and inflammation intensity were measured. The requirement for and the timing of rescue medication were also measured. RESULTS Postoperative pain and inflammation intensity were significantly higher (P < .05) in group 3 than in groups 1 or 2 at 48 hours, 72 hours, and 1 week. A significantly higher proportion of group 3 required rescue medication (analgesics and rescue antibiotics) (P = .013) compared with groups 1 or 2. CONCLUSIONS Greater pain and inflammation were experienced by patients receiving placebo before lower third molar extraction than by those receiving antibiotics either before surgery or both before and after surgery. Other options, such as use of local antibiotics, should be considered to reduce the problems, including bacterial resistance, caused by overuse of systemic antibiotics.",2021,A significantly higher proportion of group 3 required rescue medication (analgesics and rescue antibiotics),['92 Caucasian volunteers'],"['750 mg oral amoxicillin', 'placebo']","['pain and inflammation', 'Infectious complications, postoperative pain, and inflammation intensity', 'Postoperative pain and inflammation intensity', 'rescue medication (analgesics and rescue antibiotics']","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]",92.0,0.61802,A significantly higher proportion of group 3 required rescue medication (analgesics and rescue antibiotics),"[{'ForeName': 'Maria Del Mar', 'Initials': 'MDM', 'LastName': 'Mariscal-Cazalla', 'Affiliation': 'Student, Department of Oral and Maxillofacial Surgery, University of Granada, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Manzano-Moreno', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, University of Granada, Spain. Electronic address: Fjmanza@ugr.es.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'García-Vázquez', 'Affiliation': 'Student, Department of Oral and Maxillofacial Surgery, University of Granada, Spain.'}, {'ForeName': 'Manuel F', 'Initials': 'MF', 'LastName': 'Vallecillo-Capilla', 'Affiliation': 'Professor, Department of Oral and Maxillofacial Surgery; Director, Oral Surgery and Implantology Masters Clinic, University of Granada, Spain.'}, {'ForeName': 'Maria Victoria', 'Initials': 'MV', 'LastName': 'Olmedo-Gaya', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, University of Granada, Spain.'}]","Oral surgery, oral medicine, oral pathology and oral radiology",['10.1016/j.oooo.2020.08.034'] 997,33188138,"Treatment of mild-to-moderate pelvic inflammatory disease with a short-course azithromycin-based regimen versus ofloxacin plus metronidazole: results of a multicentre, randomised controlled trial.","OBJECTIVE A multicentre, randomised non-inferiority trial compared the efficacy and safety of 14 days of ofloxacin and metronidazole (standard-of-care (SoC)) versus a single dose of intramuscular ceftriaxone followed by 5 days of azithromycin and metronidazole (intervention arm (IA)) in women with mild-to-moderate pelvic inflammatory disease (PID). METHODS Women with a clinical diagnosis of PID presenting at sexual health services were randomised to the SoC or IA arms. Treating clinicians and participants were not blinded to treatment allocation but the clinician performing the assessment of primary outcome was blinded. The primary outcome was clinical cure defined as ≥70% reduction in the modified McCormack pain score at day 14-21 after starting treatment. Secondary outcomes included adherence, tolerability and microbiological cure. RESULTS Of the randomised population 72/153 (47.1%) reached the primary end point in the SoC arm, compared with 68/160 (42.5%) in the IA (difference in cure 4.6% (95% CI -15.6% to 6.5%). Following exclusion of 86 women who were lost to follow-up, attended outside the day 14-21 follow-up period, or withdrew consent, 72/107 (67.3%) had clinical cure in the SoC arm compared with 68/120 (56.7%) in the IA, giving a difference in cure rate of 10.6% (95% CI -23.2% to 1.9%). We were unable to demonstrate non-inferiority of the IA compared with SoC arm. Women in the IA took more treatment doses compared with the SoC group (113/124 (91%) vs 75/117 (64%), p=0.0001), but were more likely to experience diarrhoea (61% vs 24%, p<0.0001). Of 288 samples available for analysis, Mycoplasma genitalium was identified in 10% (28/288), 58% (11/19) of which had baseline antimicrobial resistance-associated mutations. CONCLUSION A short-course azithromycin-based regimen is likely to be less effective than the standard treatment with ofloxacin plus metronidazole. The high rate of baseline antimicrobial resistance supports resistance testing in those with M. genitalium infection to guide appropriate therapy. TRIAL REGISTRATION NUMBER 2010-023254-36.",2021,The primary outcome was clinical cure defined as ≥70% reduction in the modified McCormack pain score at day 14-21 after starting treatment.,"['Women with a clinical diagnosis of PID presenting at sexual health services', 'women with mild-to-moderate pelvic inflammatory disease (PID', 'mild-to-moderate pelvic inflammatory disease with a short-course']","['ofloxacin and metronidazole (standard-of-care (SoC', 'intramuscular ceftriaxone', 'azithromycin and metronidazole (intervention arm (IA', 'ofloxacin plus metronidazole', 'azithromycin']","['baseline antimicrobial resistance-associated mutations', 'experience diarrhoea', 'efficacy and safety', 'clinical cure', 'cure rate', 'Mycoplasma genitalium', 'clinical cure defined as ≥70% reduction in the modified McCormack pain score', 'adherence, tolerability and microbiological cure']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0242172', 'cui_str': 'Female pelvic inflammatory disease'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0028902', 'cui_str': 'Ofloxacin'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0317872', 'cui_str': 'Mycoplasma genitalium'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}]",,0.496134,The primary outcome was clinical cure defined as ≥70% reduction in the modified McCormack pain score at day 14-21 after starting treatment.,"[{'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Dean', 'Affiliation': 'Department of Sexual Health and HIV, Brighton and Sussex University Hospitals NHS Trust, Brighton, E Sussex, UK gillian.dean2@nhs.net.'}, {'ForeName': 'Suneeta', 'Initials': 'S', 'LastName': 'Soni', 'Affiliation': 'Department of Sexual Health and HIV, Brighton and Sussex University Hospitals NHS Trust, Brighton, E Sussex, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Pitt', 'Affiliation': 'Antimicrobial Resistance and Healthcare Associated Infections (AMRHAI) Reference Unit, National Infection Service, Public Health England, London, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Ross', 'Affiliation': 'Whittall Street Clinic, University Hospital Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Sabin', 'Affiliation': 'Department of Medical Statistics and Epidemiology, University College London, London, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Whetham', 'Affiliation': 'Department of Sexual Health and HIV, Brighton and Sussex University Hospitals NHS Trust, Brighton, E Sussex, UK.'}]",Sexually transmitted infections,['10.1136/sextrans-2020-054468'] 998,33188141,"FDA Approval Summary: Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Injection for Subcutaneous Use in Patients with HER2-positive Breast Cancer.","On June 29, 2020, the FDA approved pertuzumab, trastuzumab, and hyaluronidase-zzxf subcutaneous injection (Phesgo) for the treatment of patients with HER2-positive early-stage and metastatic breast cancer. Patients should be selected for therapy based on an FDA-approved companion diagnostic test. Approval was primarily based on the FeDeriCa trial, a randomized, open-label, multicenter comparability study of pertuzumab, trastuzumab, and hyaluronidase-zzxf subcutaneous injection compared with intravenous pertuzumab and intravenous trastuzumab administered in the neoadjuvant and adjuvant settings with chemotherapy for the treatment of patients with early breast cancer. The pharmacokinetic endpoints were, first, to demonstrate that the exposure of subcutaneous pertuzumab was not inferior to that of intravenous pertuzumab, and then to demonstrate that the exposure of subcutaneous trastuzumab was not inferior to that of intravenous trastuzumab. The primary endpoints were met with the observed lower limit of the two-sided 90% confidence intervals above the prespecified noninferiority margins. The most common adverse reactions were alopecia, nausea, diarrhea, anemia, and asthenia. The totality of the evidence demonstrated comparability of the subcutaneous product to intravenous, allowing for extrapolation and approval of all breast cancer indications for which intravenous trastuzumab and pertuzumab are approved.",2021,"The most common adverse reactions were alopecia, nausea, diarrhea, anemia, and asthenia.","['patients with early breast cancer', 'patients with HER2-positive early stage and metastatic breast cancer', 'Patients with HER2-Positive Breast Cancer']","['pertuzumab, trastuzumab, and hyaluronidase-zzxf subcutaneous injection compared to intravenous (IV) pertuzumab and IV trastuzumab', 'Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf injection']","['alopecia, nausea, diarrhea, anemia, and asthenia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}]","[{'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0020197', 'cui_str': 'Hyaluronidase'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}]",,0.0264154,"The most common adverse reactions were alopecia, nausea, diarrhea, anemia, and asthenia.","[{'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Gao', 'Affiliation': 'Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland. jennifer.gao@fda.hhs.gov.'}, {'ForeName': 'Christy L', 'Initials': 'CL', 'LastName': 'Osgood', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Yutao', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Erik W', 'Initials': 'EW', 'LastName': 'Bloomquist', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Xiling', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Junshan', 'Initials': 'J', 'LastName': 'Qiu', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Jingyu', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Song', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Nam Atiqur', 'Initials': 'NA', 'LastName': 'Rahman', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Haw-Jyh', 'Initials': 'HJ', 'LastName': 'Chiu', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Tiffany K', 'Initials': 'TK', 'LastName': 'Ricks', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Rizvi', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Hou', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Willie', 'Initials': 'W', 'LastName': 'Wilson', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Abde M', 'Initials': 'AM', 'LastName': 'Abukhdeir', 'Affiliation': 'Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Seidman', 'Affiliation': 'Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Soma', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': 'Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Philip', 'Affiliation': 'Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Pierce', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Bhatnagar', 'Affiliation': 'Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Kluetz', 'Affiliation': 'Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pazdur', 'Affiliation': 'Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Beaver', 'Affiliation': 'Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Laleh', 'Initials': 'L', 'LastName': 'Amiri-Kordestani', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-3474'] 999,32668114,Timing of Initiation of Renal-Replacement Therapy in Acute Kidney Injury.,"BACKGROUND Acute kidney injury is common in critically ill patients, many of whom receive renal-replacement therapy. However, the most effective timing for the initiation of such therapy remains uncertain. METHODS We conducted a multinational, randomized, controlled trial involving critically ill patients with severe acute kidney injury. Patients were randomly assigned to receive an accelerated strategy of renal-replacement therapy (in which therapy was initiated within 12 hours after the patient had met eligibility criteria) or a standard strategy (in which renal-replacement therapy was discouraged unless conventional indications developed or acute kidney injury persisted for >72 hours). The primary outcome was death from any cause at 90 days. RESULTS Of the 3019 patients who had undergone randomization, 2927 (97.0%) were included in the modified intention-to-treat analysis (1465 in the accelerated-strategy group and 1462 in the standard-strategy group). Of these patients, renal-replacement therapy was performed in 1418 (96.8%) in the accelerated-strategy group and in 903 (61.8%) in the standard-strategy group. At 90 days, death had occurred in 643 patients (43.9%) in the accelerated-strategy group and in 639 (43.7%) in the standard-strategy group (relative risk, 1.00; 95% confidence interval [CI], 0.93 to 1.09; P = 0.92). Among survivors at 90 days, continued dependence on renal-replacement therapy was confirmed in 85 of 814 patients (10.4%) in the accelerated-strategy group and in 49 of 815 patients (6.0%) in the standard-strategy group (relative risk, 1.74; 95% CI, 1.24 to 2.43). Adverse events occurred in 346 of 1503 patients (23.0%) in the accelerated-strategy group and in 245 of 1489 patients (16.5%) in the standard-strategy group (P<0.001). CONCLUSIONS Among critically ill patients with acute kidney injury, an accelerated renal-replacement strategy was not associated with a lower risk of death at 90 days than a standard strategy. (Funded by the Canadian Institutes of Health Research and others; STARRT-AKI ClinicalTrials.gov number, NCT02568722.).",2020,"At 90 days, death had occurred in 643 patients (43.9%) in the accelerated-strategy group and in 639 (43.7%) in the standard-strategy group (relative risk, 1.00; 95% confidence interval [CI], 0.93 to 1.09; P = 0.92).","['critically ill patients with severe acute kidney injury', 'critically ill patients with acute kidney injury', 'Acute Kidney Injury', 'critically ill patients, many of whom receive renal-replacement therapy', '3019 patients who had undergone randomization, 2927 (97.0%) were included in the modified intention-to-treat analysis (1465 in the accelerated-strategy group and 1462 in the standard-strategy group']","['standard strategy (in which renal-replacement therapy', 'Renal-Replacement Therapy', 'accelerated strategy of renal-replacement therapy']","['Adverse events', 'death', 'death from any cause at 90 days', 'lower risk of death', 'renal-replacement therapy']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}]",3019.0,0.2899,"At 90 days, death had occurred in 643 patients (43.9%) in the accelerated-strategy group and in 639 (43.7%) in the standard-strategy group (relative risk, 1.00; 95% confidence interval [CI], 0.93 to 1.09; P = 0.92).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Bagshaw', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Wald', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Neill K J', 'Initials': 'NKJ', 'LastName': 'Adhikari', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Bruno R', 'Initials': 'BR', 'LastName': 'da Costa', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Dreyfuss', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Du', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Martin P', 'Initials': 'MP', 'LastName': 'Gallagher', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Gaudry', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Hoste', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lamontagne', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Joannidis', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Landoni', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Kathleen D', 'Initials': 'KD', 'LastName': 'Liu', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'McAuley', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Shay P', 'Initials': 'SP', 'LastName': 'McGuinness', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Javier A', 'Initials': 'JA', 'LastName': 'Neyra', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Alistair D', 'Initials': 'AD', 'LastName': 'Nichol', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'Ostermann', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Palevsky', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Pettilä', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Quenot', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Qiu', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Rochwerg', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Antoine G', 'Initials': 'AG', 'LastName': 'Schneider', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Orla M', 'Initials': 'OM', 'LastName': 'Smith', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Thomé', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Thorpe', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Suvi', 'Initials': 'S', 'LastName': 'Vaara', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Weir', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Amanda Y', 'Initials': 'AY', 'LastName': 'Wang', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Young', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Zarbock', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}]",The New England journal of medicine,['10.1056/NEJMoa2000741'] 1000,33137868,"The Impact of a Motor Imagery-Based Training Program on Agility, Speed, and Reaction Time in a Sample of Young Tennis Athletes during Ramadan Fasting: Insights and Implications from a Randomized, Controlled Experimental Trial.","The objective of this study was to explore whether a training program incorporating motor imagery could have an effect on physical performance outcomes in terms of agility, speed, and reaction time in a sample of tennis athletes who fasted during the month of Ramadan. Recruited subjects were 27 young male tennis players, randomly allocated to two groups: the imaging training group ( n = 13) and a control group ( n = 14). The study was designed as a randomized, controlled experimental study. The control group was engaged in watching videos concerning the history of the Olympic Games, whereas the motor imagery group followed a motor imagery-based training program. Physical performance outcomes were assessed during four sessions (one before Ramadan and three during Ramadan) by means of field tests. Our results revealed a drop in all performance outcomes measured in the middle and at the end of Ramadan for both groups ( p < 0.01). The effect of the group × time interaction ( p < 0.01) was reported for all physical performance outcomes measured for the two groups. This drop in performance was greater for the control group compared to the motor imagery group in the middle and at the end of Ramadan. This study showed that fasting during Ramadan reduced agility, speed, and reaction time performance for tennis players. A motor imagery-based training program could be an effective approach to reduce the effect of fasting during Ramadan and stabilize physical performance outcomes in terms of agility, speed, and reaction time for male tennis players.",2020,This drop in performance was greater for the control group compared to the motor imagery group in the middle and at the end of Ramadan.,"['Recruited subjects were 27 young male tennis players', 'tennis athletes who fasted during the month of Ramadan', 'tennis players', 'male tennis players', 'Young Tennis Athletes during Ramadan Fasting']","['watching videos concerning the history of the Olympic Games, whereas the motor imagery group followed a motor imagery-based training program', 'imaging training group', 'Motor Imagery-Based Training Program', 'training program incorporating motor imagery', 'motor imagery-based training program']","['agility, speed, and reaction time', 'Agility, Speed, and Reaction Time', 'agility, speed, and reaction time performance', 'Physical performance outcomes']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0039515', 'cui_str': 'Tennis'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",27.0,0.0349166,This drop in performance was greater for the control group compared to the motor imagery group in the middle and at the end of Ramadan.,"[{'ForeName': 'Sofien', 'Initials': 'S', 'LastName': 'Fekih', 'Affiliation': 'Higher Institute of Sport and Physical Education of Gafsa, Gafsa 2100, Tunisia.'}, {'ForeName': 'Mohamed Sami', 'Initials': 'MS', 'LastName': 'Zguira', 'Affiliation': 'Higher Institute of Sport and Physical Education of Gafsa, Gafsa 2100, Tunisia.'}, {'ForeName': 'Abdessalem', 'Initials': 'A', 'LastName': 'Koubaa', 'Affiliation': 'Higher Institute of Sport and Physical Education of Gafsa, Gafsa 2100, Tunisia.'}, {'ForeName': 'Imed', 'Initials': 'I', 'LastName': 'Ghariani', 'Affiliation': 'National Centre of Medicine and Science in Sport, Tunis 2000, Tunisia.'}, {'ForeName': 'Hamdi', 'Initials': 'H', 'LastName': 'Zguira', 'Affiliation': 'Higher Institute of Sport and Physical Education of Gafsa, Gafsa 2100, Tunisia.'}, {'ForeName': 'Nicola Luigi', 'Initials': 'NL', 'LastName': 'Bragazzi', 'Affiliation': 'Postgraduate School of Public Health, Department of Health Sciences (DISSAL), Genoa University, 16132 Genoa, Italy.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Jarraya', 'Affiliation': 'Research Laboratory: Education, Motricity, Sports and Health (EM2S, LR19JS01), Higher Institute of Sport and Physical Education of Sfax, University of Sfax, Sfax 3100, Tunisia.'}]",Nutrients,['10.3390/nu12113306'] 1001,33141092,A Mobile-Based Intervention for Dietary Behavior and Physical Activity Change in Individuals at High Risk for Type 2 Diabetes Mellitus: Randomized Controlled Trial.,"BACKGROUND Intensive lifestyle modifications have proved effective in preventing type 2 diabetes mellitus (T2DM), yet the efficiency and effectiveness of these modifications need to be improved. Emerging social media interventions are considered useful in promoting these lifestyles; nevertheless, few studies have investigated the effectiveness of combining them with behavior theory. OBJECTIVE This study aims to examine the effectiveness of a 6-month mobile-based intervention (DHealthBar, a WeChat applet) combined with behavioral theory compared with a printed intervention in improving dietary behaviors, physical activity, and intention to change these behaviors among populations at high risk for T2DM. METHODS Participants aged 23 to 67 years were recruited offline in Beijing, China, and were randomized into the intervention group or the control group, which received educational content via DHealthBar or a printed handbook, respectively. Educational materials were culturally tailored recommendations on improving dietary behaviors, physical activity, and intention to change based on the transtheoretical model. Participants in the intervention arm received push notifications twice per week on WeChat and had access to the educational content for the 6-month study period. Participants in the control arm received the same intervention content through printed materials. The outcomes of participants' behavior change, intention to change behavior, and anthropometric characteristics were collected via online measuring tools at baseline, 3 months, and 6 months. RESULTS In this study, 79 enrolled individuals completed baseline information collection (control: n=38 vs intervention: n=41), and 96% (76/79) completed the 6-month follow-up visit. Attrition rates did not differ significantly between the 2 groups (χ 2 1 =0.0, P=.61). Baseline equivalence was found. Participants in both groups reported a statistically significant decrease in energy intake at the 2 follow-up assessments compared with baseline (3 months, control: exp[β]=0.83, 95% CI 0.74-0.92 vs intervention: exp[β]=0.76, 95% CI 0.68-0.85; 6 months, control: exp[β]=0.87, 95% CI 0.78-0.96 vs intervention: exp[β]=0.57, 95% CI 0.51-0.64). At 6 months, a significantly larger decrease was observed in the intervention group in energy, fat, and carbohydrate intake, accompanied with a significantly larger increase in moderate-intensity physical activity compared with the control group (energy: exp[β]=0.66, 95% CI 0.56-0.77; fat: exp[β]=0.71, 95% CI 0.54-0.95; carbohydrates: exp[β]=0.83, 95% CI 0.66-1.03; moderate-intensity physical activity: exp[β]=2.05, 95% CI 1.23-3.44). After 6 months of the intervention, participants in the intervention group were more likely to be at higher stages of dietary behaviors (exp[β]=26.80, 95% CI 3.51-204.91) and physical activity (exp[β]=15.60, 95% CI 2.67-91.04) than the control group. CONCLUSIONS DHealthBar was initially effective in improving dietary behavior, physical activity, and intention to change these behaviors among populations who were at high risk of developing T2DM, with significant differences in the changes of outcomes over the 6-month intervention period. TRIAL REGISTRATION Chinese Clinical Trial Registry ChiCTR2000032323; https://tinyurl.com/y4h8q4uf.",2020,"Attrition rates did not differ significantly between the 2 groups (χ 2 1 =0.0, P=.61).","['populations at high risk for T2DM', 'Individuals at High Risk for Type 2 Diabetes Mellitus', '79 enrolled individuals completed baseline information collection (control: n=38 vs intervention: n=41), and 96% (76/79) completed the 6-month follow-up visit', 'Participants aged 23 to 67 years were recruited offline in Beijing, China']","['educational content via DHealthBar or a printed handbook, respectively', '6-month mobile-based intervention (DHealthBar, a WeChat applet) combined with behavioral theory compared with a printed intervention', 'push notifications twice per week on WeChat', 'Mobile-Based Intervention for Dietary Behavior and Physical Activity Change']","['dietary behavior, physical activity, and intention', ""participants' behavior change, intention to change behavior, and anthropometric characteristics"", 'dietary behaviors, physical activity, and intention to change based on the transtheoretical model', 'physical activity', 'moderate-intensity physical activity', 'energy intake', 'dietary behaviors', 'Attrition rates', 'energy, fat, and carbohydrate intake']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0596654', 'cui_str': 'Handbooks'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0422202', 'cui_str': 'Notifications'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",79.0,0.149961,"Attrition rates did not differ significantly between the 2 groups (χ 2 1 =0.0, P=.61).","[{'ForeName': 'Zidu', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Institute of Medical Information and Library, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Geng', 'Affiliation': 'School of Nursing, Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Kexin', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'Nursing Department, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Institute of Medical Information and Library, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'School of Nursing, Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Institute of Medical Information and Library, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",JMIR mHealth and uHealth,['10.2196/19869'] 1002,33150554,How isolation of key information and allowing clarifying questions may improve information quality and diagnostic accuracy at case handover in paediatrics.,"Handover between colleagues is a complex task. The problem is that handovers are often inadequate because they are not structured according to theoretically grounded guidelines. Based on the cognitive load theory, we suggest that allowing a clarifying dialogue and thereby optimizing germane cognitive load enhances the information quality and diagnostic accuracy at handover, but may prolong handover duration. We also expect that mentioning key information first and thus decreasing intrinsic cognitive load improves information quality and diagnostic accuracy. We developed two representative paediatric cases for presentation in a factorial 2 × 2 design. Sixth-year medical students (N = 80) were randomly assigned to one of four groups that differed with regard to how the case histories were delivered to them (chronological order versus key information mentioned first) and direction of information exchange (unidirectional versus a clarifying dialogue). The receivers of the handover were asked to write a report of the cases and suggest the best diagnosis. Dependent variables were information quality of the written report (Information score), quality of the diagnosis (Diagnostic accuracy score) and the time it took to deliver the written handover case report (Handover report duration). Seen through the lens of cognitive load theory, allowing a clarifying dialogue at handover, and thus optimizing the germane cognitive load, significantly increased the Information score (p < 0.0005), Diagnostic accuracy score (< 0.05) and Handover report duration (p < 0.001).",2021,"Dependent variables were information quality of the written report (Information score), quality of the diagnosis (Diagnostic accuracy score) and the time it took to deliver the written handover case report (Handover report duration).",['Sixth-year medical students (N\u2009=\u200980'],['case histories were delivered to them (chronological order versus key information mentioned first) and direction of information exchange (unidirectional versus a clarifying dialogue'],"['information quality of the written report (Information score), quality of the diagnosis (Diagnostic accuracy score) and the time it took to deliver the written handover case report (Handover report duration', 'Diagnostic accuracy score', 'Information score']","[{'cui': 'C0205440', 'cui_str': 'Sixth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C0085970', 'cui_str': 'Case Histories'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007320', 'cui_str': 'Case Reports'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",80.0,0.0245219,"Dependent variables were information quality of the written report (Information score), quality of the diagnosis (Diagnostic accuracy score) and the time it took to deliver the written handover case report (Handover report duration).","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Balslev', 'Affiliation': 'Department of Paediatrics, Viborg Regional Hospital, Viborg, Denmark. thomas.balslev@midt.rm.dk.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Muijtjens', 'Affiliation': 'Department of Educational Development and Research, Faculty of Health Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'de Grave', 'Affiliation': 'Department of Educational Development and Research, Faculty of Health Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Awneh', 'Affiliation': 'Department of Paediatrics, Viborg Regional Hospital, Viborg, Denmark.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van Merriënboer', 'Affiliation': 'Department of Educational Development and Research, Faculty of Health Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands.'}]",Advances in health sciences education : theory and practice,['10.1007/s10459-020-10001-2'] 1003,33150572,Neuromuscular Electrical Stimulation and High-Protein Supplementation After Subarachnoid Hemorrhage: A Single-Center Phase 2 Randomized Clinical Trial.,"INTRODUCTION Aneurysmal subarachnoid hemorrhage (SAH) survivors live with long-term residual physical and cognitive disability. We studied whether neuromuscular electrical stimulation (NMES) and high-protein supplementation (HPRO) in the first 2 weeks after SAH could preserve neuromotor and cognitive function as compared to standard of care (SOC) for nutrition and mobilization. METHODS SAH subjects with a Hunt Hess (HH) grade > 1,modified Fisher score > 1 and BMI < 40 kg/m 2 were randomly assigned to SOC or NMES + HPRO. NMES was delivered to bilateral quadricep muscles daily during two 30-min sessions along with HPRO (goal:1.8 g/kg/day) between post-bleed day (PBD) 0 and 14. Primary endpoint was atrophy in the quadricep muscle as measured by the percentage difference in the cross-sectional area from baseline to PBD14 on CT scan. All subjects underwent serial assessments of physical (short performance physical battery, SPPB) cognitive (Montreal Cognitive Assessment Scale, MoCA) and global functional recovery (modified Rankin Scale, mRS) at PBD 14, 42, and 90. RESULTS Twenty-five patients (SOC = 13, NMES + HPRO = 12) enrolled between December 2017 and January 2019 with no between-group differences in baseline characteristics (58 years old, 68% women, 50% HH > 3). Median duration of interventions was 12 days (range 9-14) with completion of 98% of NMES sessions and 83% of goal HPRO, and no reported serious adverse events. There was no difference in caloric intake between groups, but HPRO + NMES group received more protein (1.5 ± 0.5 g/kg/d v 0.9 ± 0.4 g/kg/d, P < 0.01). Muscle atrophy was less in NMES + HPRO than the SOC group (6.5 ± 4.1% vs 12.5 ± 6.4%, P 0.01). Higher atrophy was correlated with lower daily protein intake (ρ = - 0.45, P = 0.03) and lower nitrogen balance (ρ = 0.47, P  = 0.02); and worse 3 month SPPB (ρ = -  0.31, P = 0.1) and mRS (ρ = 0.4, P  = 0.04). NMES + HPRO patients had a better median [25%,75] SPPB (12[10, 12] v. 9 [4, 12], P = 0.01) and mRS (1[0,2] v.2[1, 3], P = 0.04) than SOC at PBD 90. CONCLUSIONS NMES + HPRO appears to be feasible and safe acutely after SAH and may reduce acute quadriceps muscle wasting with a lasting benefit on recovery after SAH.",2020,"Muscle atrophy was less in NMES + HPRO than the SOC group (6.5 ± 4.1% vs 12.5 ± 6.4%, P 0.01).","['Twenty-five patients (SOC\u2009=\u200913, NMES\u2009+\u2009HPRO\u2009=\u200912) enrolled between December 2017 and January 2019 with no between-group differences in baseline characteristics (58\xa0years old, 68% women, 50% HH\u2009>\u20093', 'SAH subjects with a Hunt Hess (HH) grade\u2009', 'After Subarachnoid Hemorrhage', '1,modified Fisher score\u2009>\u20091 and BMI\u2009<\u200940\xa0kg/m 2']","['NMES', 'Neuromuscular Electrical Stimulation and High-Protein Supplementation', 'neuromuscular electrical stimulation (NMES) and high-protein supplementation (HPRO']","['Higher atrophy', 'physical (short performance physical battery, SPPB) cognitive (Montreal Cognitive Assessment Scale, MoCA) and global functional recovery (modified Rankin Scale, mRS', 'Median duration of interventions', 'atrophy in the quadricep muscle', 'caloric intake', 'daily protein intake', 'Muscle atrophy', 'lower nitrogen balance', 'serious adverse events']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038525', 'cui_str': 'Subarachnoid hemorrhage'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0325045', 'cui_str': 'Martes pennanti'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0429631', 'cui_str': 'Nitrogen balance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0776419,"Muscle atrophy was less in NMES + HPRO than the SOC group (6.5 ± 4.1% vs 12.5 ± 6.4%, P 0.01).","[{'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Badjatia', 'Affiliation': 'Program in Trauma, University of Maryland School of Medicine, 22 S. Greene Street G7K19, Baltimore, MD, 21201, USA. nbadjatia@som.umaryland.edu.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Sanchez', 'Affiliation': 'Departments of Neurology, University of Maryland School of Medicine, Baltimore, USA.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Judd', 'Affiliation': 'Department of Clinical Nutrition, University of Maryland Medical Center, Baltimore, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Hausladen', 'Affiliation': 'Advanced Practice Provider Program, Neurocritical Care Unit, University of Maryland Medical Center, Baltimore, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hering', 'Affiliation': 'Advanced Practice Provider Program, Neurocritical Care Unit, University of Maryland Medical Center, Baltimore, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Motta', 'Affiliation': 'Program in Trauma, University of Maryland School of Medicine, 22 S. Greene Street G7K19, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Gunjan', 'Initials': 'G', 'LastName': 'Parikh', 'Affiliation': 'Program in Trauma, University of Maryland School of Medicine, 22 S. Greene Street G7K19, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Chang', 'Affiliation': 'Program in Trauma, University of Maryland School of Medicine, 22 S. Greene Street G7K19, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Morris', 'Affiliation': 'Program in Trauma, University of Maryland School of Medicine, 22 S. Greene Street G7K19, Baltimore, MD, 21201, USA.'}, {'ForeName': 'J Marc', 'Initials': 'JM', 'LastName': 'Simard', 'Affiliation': 'Department of Neurosurgery, University of Maryland School of Medicine, Baltimore, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sorkin', 'Affiliation': 'Department of Medicine, University of Maryland School of Medicine, Baltimore, USA.'}, {'ForeName': 'George F', 'Initials': 'GF', 'LastName': 'Wittenberg', 'Affiliation': 'Departments of Neurology, University of Maryland School of Medicine, Baltimore, USA.'}, {'ForeName': 'Alice S', 'Initials': 'AS', 'LastName': 'Ryan', 'Affiliation': 'Department of Medicine, University of Maryland School of Medicine, Baltimore, USA.'}]",Neurocritical care,['10.1007/s12028-020-01138-4'] 1004,33159256,Effect of mizoribine pulse therapy in adult membranous nephropathy.,"Membraneous nephropathy (MN) is one of the complicated kidney diseases associated with proteinuria. Mizoribine (MZR) is an emerging treatment option for nephrotic syndrome; however, its dosage and administration are yet lack of consensus. This study aims to evaluate the efficacy and safety of high-dose MZR pulse therapy for adult membraneous nephropathy. Sixty patients with membraneous nephropathy were recruited, and assigned to two treatment groups. One group received conventional treatment of steroid combining with cyclophosphamide (CPM), the other group received steroid combining with high-dose MZR pulse administration. Both groups were followed up for 1 year. Treatment efficacy and side effects were measured regularly. Fifty-nine patients completed the treatment courses. There was no significant difference in demographic and disease conditions prior to treatment between two treatment groups. Both groups showed significant decrease of urine proteins and increase of serum albumin levels after treatments with no severe side effects. After 6 months of treatment, MZR group has 71% reduction (compared to 74.4% reduction in CPM group) in urine protein compared to baseline after adjusting for age and gender. 89.7% of patients in CPM and 93.3% in MZR groups had partial/ complete remission after 12 months. This study demonstrated satisfactory safety and efficacy of high-dose mizoribine pulse administration combining with steroid treatment for adult patients with membranous nephropathy.",2021,"After 6 months of treatment, MZR group has 71% reduction (compared to 74.4% reduction in CPM group) in urine protein compared to baseline after adjusting for age and gender.","['Sixty patients with membraneous nephropathy', 'adult membraneous nephropathy', 'nephrotic syndrome', 'adult patients with membranous nephropathy', 'adult membranous nephropathy']","['high-dose MZR pulse therapy', 'MZR', 'mizoribine pulse administration combining with steroid treatment', 'steroid combining with high-dose MZR pulse administration', 'conventional treatment of steroid combining with cyclophosphamide (CPM', 'Mizoribine (MZR', 'mizoribine pulse therapy']","['efficacy and safety', 'serum albumin levels', 'partial/ complete remission', 'satisfactory safety and efficacy', 'Treatment efficacy and side effects', 'urine proteins', 'demographic and disease conditions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027726', 'cui_str': 'Nephrotic syndrome'}, {'cui': 'C0017665', 'cui_str': 'Membranous glomerulonephritis'}]","[{'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0128608', 'cui_str': 'Mizoribine'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0262923', 'cui_str': 'Urine protein test'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",60.0,0.0271305,"After 6 months of treatment, MZR group has 71% reduction (compared to 74.4% reduction in CPM group) in urine protein compared to baseline after adjusting for age and gender.","[{'ForeName': 'Xichao', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, Tianjin First Central Hospital, No.24 Fukang Road, Tianjin, 300192, China.'}, {'ForeName': 'Miaomiao', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Nephrology, Tianjin First Central Hospital, No.24 Fukang Road, Tianjin, 300192, China.'}, {'ForeName': 'Wenyu', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Nephrology, Tianjin First Central Hospital, No.24 Fukang Road, Tianjin, 300192, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Nephrology, Tianjin First Central Hospital, No.24 Fukang Road, Tianjin, 300192, China.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Nephrology, Tianjin First Central Hospital, No.24 Fukang Road, Tianjin, 300192, China.'}, {'ForeName': 'Wenxiu', 'Initials': 'W', 'LastName': 'Chang', 'Affiliation': 'Department of Nephrology, Tianjin First Central Hospital, No.24 Fukang Road, Tianjin, 300192, China. ccxichao@sina.com.'}]",International urology and nephrology,['10.1007/s11255-020-02680-y'] 1005,33165621,Effect of Hydroxychloroquine on Clinical Status at 14 Days in Hospitalized Patients With COVID-19: A Randomized Clinical Trial.,"Importance Data on the efficacy of hydroxychloroquine for the treatment of coronavirus disease 2019 (COVID-19) are needed. Objective To determine whether hydroxychloroquine is an efficacious treatment for adults hospitalized with COVID-19. Design, Setting, and Participants This was a multicenter, blinded, placebo-controlled randomized trial conducted at 34 hospitals in the US. Adults hospitalized with respiratory symptoms from severe acute respiratory syndrome coronavirus 2 infection were enrolled between April 2 and June 19, 2020, with the last outcome assessment on July 17, 2020. The planned sample size was 510 patients, with interim analyses planned after every 102 patients were enrolled. The trial was stopped at the fourth interim analysis for futility with a sample size of 479 patients. Interventions Patients were randomly assigned to hydroxychloroquine (400 mg twice daily for 2 doses, then 200 mg twice daily for 8 doses) (n = 242) or placebo (n = 237). Main Outcomes and Measures The primary outcome was clinical status 14 days after randomization as assessed with a 7-category ordinal scale ranging from 1 (death) to 7 (discharged from the hospital and able to perform normal activities). The primary outcome was analyzed with a multivariable proportional odds model, with an adjusted odds ratio (aOR) greater than 1.0 indicating more favorable outcomes with hydroxychloroquine than placebo. The trial included 12 secondary outcomes, including 28-day mortality. Results Among 479 patients who were randomized (median age, 57 years; 44.3% female; 37.2% Hispanic/Latinx; 23.4% Black; 20.1% in the intensive care unit; 46.8% receiving supplemental oxygen without positive pressure; 11.5% receiving noninvasive ventilation or nasal high-flow oxygen; and 6.7% receiving invasive mechanical ventilation or extracorporeal membrane oxygenation), 433 (90.4%) completed the primary outcome assessment at 14 days and the remainder had clinical status imputed. The median duration of symptoms prior to randomization was 5 days (interquartile range [IQR], 3 to 7 days). Clinical status on the ordinal outcome scale at 14 days did not significantly differ between the hydroxychloroquine and placebo groups (median [IQR] score, 6 [4-7] vs 6 [4-7]; aOR, 1.02 [95% CI, 0.73 to 1.42]). None of the 12 secondary outcomes were significantly different between groups. At 28 days after randomization, 25 of 241 patients (10.4%) in the hydroxychloroquine group and 25 of 236 (10.6%) in the placebo group had died (absolute difference, -0.2% [95% CI, -5.7% to 5.3%]; aOR, 1.07 [95% CI, 0.54 to 2.09]). Conclusions and Relevance Among adults hospitalized with respiratory illness from COVID-19, treatment with hydroxychloroquine, compared with placebo, did not significantly improve clinical status at day 14. These findings do not support the use of hydroxychloroquine for treatment of COVID-19 among hospitalized adults. Trial Registration ClinicalTrials.gov: NCT04332991.",2020,"Clinical status on the ordinal outcome scale at 14 days did not significantly differ between the hydroxychloroquine and placebo groups (median [IQR] score, 6 [4-7] vs 6 [4-7]; aOR, 1.02 [95% CI, 0.73 to 1.42]).","['Adults hospitalized with respiratory symptoms from severe acute respiratory syndrome coronavirus 2 infection were enrolled between April 2 and June 19, 2020, with the last outcome assessment on July 17, 2020', 'Hospitalized Patients With COVID-19', 'adults hospitalized with COVID-19', '479 patients', '479 patients who were randomized (median age, 57 years; 44.3% female; 37.2% Hispanic/Latinx; 23.4% Black; 20.1% in the intensive care unit; 46.8% receiving supplemental oxygen without positive pressure; 11.5% receiving noninvasive ventilation or nasal high-flow oxygen; and 6.7% receiving invasive mechanical ventilation or extracorporeal membrane oxygenation), 433 (90.4%) completed the primary outcome assessment at 14 days and the remainder had clinical status imputed', '510 patients, with interim analyses planned after every 102 patients were enrolled', '34 hospitals in the US', 'adults hospitalized with respiratory illness']","['placebo', 'hydroxychloroquine', 'Hydroxychloroquine']","['died', '28-day mortality', 'clinical status 14 days after randomization as assessed with a 7-category ordinal scale ranging from 1 (death) to 7 (discharged from the hospital and able to perform normal activities', 'clinical status', 'median duration of symptoms']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0085565', 'cui_str': 'Outcome Assessment (Health Care)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C4517655', 'cui_str': '23.4'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C4517800', 'cui_str': '510'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}]",12.0,0.655421,"Clinical status on the ordinal outcome scale at 14 days did not significantly differ between the hydroxychloroquine and placebo groups (median [IQR] score, 6 [4-7] vs 6 [4-7]; aOR, 1.02 [95% CI, 0.73 to 1.42]).","[{'ForeName': 'Wesley H', 'Initials': 'WH', 'LastName': 'Self', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Semler', 'Affiliation': 'Division of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Lindsay M', 'Initials': 'LM', 'LastName': 'Leither', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray, Utah.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Casey', 'Affiliation': 'Division of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Derek C', 'Initials': 'DC', 'LastName': 'Angus', 'Affiliation': 'Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Roy G', 'Initials': 'RG', 'LastName': 'Brower', 'Affiliation': 'Pulmonary and Critical Care Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Steven Y', 'Initials': 'SY', 'LastName': 'Chang', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, David Geffen School of Medicine at UCLA, Ronald Reagan-UCLA Medical Center, Los Angeles, California.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Collins', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Eppensteiner', 'Affiliation': 'Department of Surgery, Duke University, Durham, North Carolina.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Filbin', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Boston.'}, {'ForeName': 'D Clark', 'Initials': 'DC', 'LastName': 'Files', 'Affiliation': 'Section of Pulmonary, Critical Care, Allergy and Immunologic Disease, Department of Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Kevin W', 'Initials': 'KW', 'LastName': 'Gibbs', 'Affiliation': 'Section of Pulmonary, Critical Care, Allergy and Immunologic Disease, Department of Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Adit A', 'Initials': 'AA', 'LastName': 'Ginde', 'Affiliation': 'Department of Emergency Medicine, University of Colorado School of Medicine, Aurora.'}, {'ForeName': 'Michelle N', 'Initials': 'MN', 'LastName': 'Gong', 'Affiliation': 'Division of Epidemiology and Population Health, Department of Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, New York.'}, {'ForeName': 'Frank E', 'Initials': 'FE', 'LastName': 'Harrell', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, Tennessee.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Hayden', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Hough', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Oregon Health and Science University School of Medicine, Portland.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Johnson', 'Affiliation': 'Department of Emergency Medicine and Division of Pulmonary, Critical Care, and Sleep Medicine, University of Washington, Seattle.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Oregon Health and Science University School of Medicine, Portland.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Lindsell', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, Tennessee.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Matthay', 'Affiliation': 'Cardiovascular Research Institute, Departments of Medicine and Anesthesia, University of California, San Francisco.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Moss', 'Affiliation': 'Division of Pulmonary Sciences and Critical Care Medicine, University of Colorado School of Medicine, Aurora.'}, {'ForeName': 'Pauline K', 'Initials': 'PK', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor.'}, {'ForeName': 'Todd W', 'Initials': 'TW', 'LastName': 'Rice', 'Affiliation': 'Division of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Bryce R H', 'Initials': 'BRH', 'LastName': 'Robinson', 'Affiliation': 'Department of Surgery, University of Washington, Seattle.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Schoenfeld', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Nathan I', 'Initials': 'NI', 'LastName': 'Shapiro', 'Affiliation': 'Department of Emergency Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Jay S', 'Initials': 'JS', 'LastName': 'Steingrub', 'Affiliation': 'Department of Medicine, University of Massachusetts Medical School-Baystate, Springfield.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Ulysse', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Weissman', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Donald M', 'Initials': 'DM', 'LastName': 'Yealy', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'B Taylor', 'Initials': 'BT', 'LastName': 'Thompson', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Brown', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray, Utah.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Steingrub', 'Affiliation': ''}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Smithline', 'Affiliation': ''}, {'ForeName': 'Bogdan', 'Initials': 'B', 'LastName': 'Tiru', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tidswell', 'Affiliation': ''}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Kozikowski', 'Affiliation': ''}, {'ForeName': 'Sherell', 'Initials': 'S', 'LastName': 'Thornton-Thompson', 'Affiliation': ''}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'De Souza', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hou', 'Affiliation': ''}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Baron', 'Affiliation': ''}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Massaro', 'Affiliation': ''}, {'ForeName': 'Imoigele', 'Initials': 'I', 'LastName': 'Aisiku', 'Affiliation': ''}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Fredenburgh', 'Affiliation': ''}, {'ForeName': 'Raghu', 'Initials': 'R', 'LastName': 'Seethala', 'Affiliation': ''}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Johnsky', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Riker', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Seder', 'Affiliation': ''}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'May', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Baumann', 'Affiliation': ''}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Eldridge', 'Affiliation': ''}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lord', 'Affiliation': ''}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Shapiro', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Talmor', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'O’Mara', 'Affiliation': ''}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Kirk', 'Affiliation': ''}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Harrison', 'Affiliation': ''}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Kurt', 'Affiliation': ''}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Schermerhorn', 'Affiliation': ''}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Banner-Goodspeed', 'Affiliation': ''}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Boyle', 'Affiliation': ''}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Dubosh', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Filbin', 'Affiliation': ''}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Hibbert', 'Affiliation': ''}, {'ForeName': 'Blair', 'Initials': 'B', 'LastName': 'Parry', 'Affiliation': ''}, {'ForeName': 'Kendall', 'Initials': 'K', 'LastName': 'Lavin-Parsons', 'Affiliation': ''}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Pulido', 'Affiliation': ''}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Lilley', 'Affiliation': ''}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Lodenstein', 'Affiliation': ''}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Margolin', 'Affiliation': ''}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Brait', 'Affiliation': ''}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Galbraith', 'Affiliation': ''}, {'ForeName': 'Rebekah', 'Initials': 'R', 'LastName': 'Peacock', 'Affiliation': ''}, {'ForeName': 'Utsav', 'Initials': 'U', 'LastName': 'Nandi', 'Affiliation': ''}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Wachs', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Matthay', 'Affiliation': ''}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Kangelaris', 'Affiliation': ''}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Calfee', 'Affiliation': ''}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Yee', 'Affiliation': ''}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Hendey', 'Affiliation': ''}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Chang', 'Affiliation': ''}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Lim', 'Affiliation': ''}, {'ForeName': 'Nida', 'Initials': 'N', 'LastName': 'Qadir', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Tam', 'Affiliation': ''}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Beutler', 'Affiliation': ''}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Levitt', 'Affiliation': ''}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Wilson', 'Affiliation': ''}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Rogers', 'Affiliation': ''}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Vojnik', 'Affiliation': ''}, {'ForeName': 'Jonasel', 'Initials': 'J', 'LastName': 'Roque', 'Affiliation': ''}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Albertson', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Chenoweth', 'Affiliation': ''}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Adams', 'Affiliation': ''}, {'ForeName': 'Skyler', 'Initials': 'S', 'LastName': 'Pearson', 'Affiliation': ''}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Juarez', 'Affiliation': ''}, {'ForeName': 'Eyad', 'Initials': 'E', 'LastName': 'Almasri', 'Affiliation': ''}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Fayed', 'Affiliation': ''}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Hughes', 'Affiliation': ''}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Hillard', 'Affiliation': ''}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Huebinger', 'Affiliation': ''}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Vidales', 'Affiliation': ''}, {'ForeName': 'Bela', 'Initials': 'B', 'LastName': 'Patel', 'Affiliation': ''}, {'ForeName': 'Adit', 'Initials': 'A', 'LastName': 'Ginde', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Moss', 'Affiliation': ''}, {'ForeName': 'Amiran', 'Initials': 'A', 'LastName': 'Baduashvili', 'Affiliation': ''}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'McKeehan', 'Affiliation': ''}, {'ForeName': 'Lani', 'Initials': 'L', 'LastName': 'Finck', 'Affiliation': ''}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Higgins', 'Affiliation': ''}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Howell', 'Affiliation': ''}, {'ForeName': 'Ivor', 'Initials': 'I', 'LastName': 'Douglas', 'Affiliation': ''}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Haukoos', 'Affiliation': ''}, {'ForeName': 'Terra', 'Initials': 'T', 'LastName': 'Hiller', 'Affiliation': ''}, {'ForeName': 'Carolynn', 'Initials': 'C', 'LastName': 'Lyle', 'Affiliation': ''}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Cupelo', 'Affiliation': ''}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Caruso', 'Affiliation': ''}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Camacho', 'Affiliation': ''}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Gravitz', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Finigan', 'Affiliation': ''}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Griesmer', 'Affiliation': ''}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hyzy', 'Affiliation': ''}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Nelson', 'Affiliation': ''}, {'ForeName': 'Kelli', 'Initials': 'K', 'LastName': 'McDonough', 'Affiliation': ''}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Olbrich', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Kapoor', 'Affiliation': ''}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Nash', 'Affiliation': ''}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Willig', 'Affiliation': ''}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Ford', 'Affiliation': ''}, {'ForeName': 'Jayna', 'Initials': 'J', 'LastName': 'Gardner-Gray', 'Affiliation': ''}, {'ForeName': 'Mayur', 'Initials': 'M', 'LastName': 'Ramesh', 'Affiliation': ''}, {'ForeName': 'Montefiore', 'Initials': 'M', 'LastName': 'Moses', 'Affiliation': ''}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Ng Gong', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Aboodi', 'Affiliation': ''}, {'ForeName': 'Ayesha', 'Initials': 'A', 'LastName': 'Asghar', 'Affiliation': ''}, {'ForeName': 'Omowunmi', 'Initials': 'O', 'LastName': 'Amosu', 'Affiliation': ''}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Torres', 'Affiliation': ''}, {'ForeName': 'Savneet', 'Initials': 'S', 'LastName': 'Kaur', 'Affiliation': ''}, {'ForeName': 'Jen-Ting', 'Initials': 'JT', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Aluko', 'Initials': 'A', 'LastName': 'Hope', 'Affiliation': ''}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Lopez', 'Affiliation': ''}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Rosales', 'Affiliation': ''}, {'ForeName': 'Jee', 'Initials': 'J', 'LastName': 'Young You', 'Affiliation': ''}, {'ForeName': 'Jarrod', 'Initials': 'J', 'LastName': 'Mosier', 'Affiliation': ''}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Hypes', 'Affiliation': ''}, {'ForeName': 'Bhupinder', 'Initials': 'B', 'LastName': 'Natt', 'Affiliation': ''}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Borg', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Salvagio Campbell', 'Affiliation': ''}, {'ForeName': 'R Duncan', 'Initials': 'RD', 'LastName': 'Hite', 'Affiliation': ''}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Hudock', 'Affiliation': ''}, {'ForeName': 'Autumn', 'Initials': 'A', 'LastName': 'Cresie', 'Affiliation': ''}, {'ForeName': 'Faysal', 'Initials': 'F', 'LastName': 'Alhasan', 'Affiliation': ''}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Gomez-Arroyo', 'Affiliation': ''}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Duggal', 'Affiliation': ''}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Mehkri', 'Affiliation': ''}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Hastings', 'Affiliation': ''}, {'ForeName': 'Debasis', 'Initials': 'D', 'LastName': 'Sahoo', 'Affiliation': ''}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Abi Fadel', 'Affiliation': ''}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Gole', 'Affiliation': ''}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Shaner', 'Affiliation': ''}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Wimer', 'Affiliation': ''}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Meli', 'Affiliation': ''}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'King', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Terndrup', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Exline', 'Affiliation': ''}, {'ForeName': 'Sonal', 'Initials': 'S', 'LastName': 'Pannu', 'Affiliation': ''}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Robart', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Karow', 'Affiliation': ''}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hough', 'Affiliation': ''}, {'ForeName': 'Bryce', 'Initials': 'B', 'LastName': 'Robinson', 'Affiliation': ''}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Henning', 'Affiliation': ''}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Campo', 'Affiliation': ''}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Gundel', 'Affiliation': ''}, {'ForeName': 'Sakshi', 'Initials': 'S', 'LastName': 'Seghal', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Katsandres', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dean', 'Affiliation': ''}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': ''}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Krol', 'Affiliation': ''}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Jouzestani', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Huynh', 'Affiliation': ''}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Weissman', 'Affiliation': ''}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Yealy', 'Affiliation': ''}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Scholl', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Adams', 'Affiliation': ''}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'McVerry', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Angus', 'Affiliation': ''}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Schooler', 'Affiliation': ''}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'Clark', 'Initials': 'C', 'LastName': 'Files', 'Affiliation': ''}, {'ForeName': 'Chadwick', 'Initials': 'C', 'LastName': 'Miller', 'Affiliation': ''}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Gibbs', 'Affiliation': ''}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'LaRose', 'Affiliation': ''}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Flores', 'Affiliation': ''}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Koehler', 'Affiliation': ''}, {'ForeName': 'Caryn', 'Initials': 'C', 'LastName': 'Morse', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sanders', 'Affiliation': ''}, {'ForeName': 'Caitlyn', 'Initials': 'C', 'LastName': 'Langford', 'Affiliation': ''}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Nanney', 'Affiliation': ''}, {'ForeName': 'Masiku', 'Initials': 'M', 'LastName': 'MdalaGausi', 'Affiliation': ''}, {'ForeName': 'Phyllis', 'Initials': 'P', 'LastName': 'Yeboah', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Morris', 'Affiliation': ''}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Sturgill', 'Affiliation': ''}, {'ForeName': 'Sherif', 'Initials': 'S', 'LastName': 'Seif', 'Affiliation': ''}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Cassity', 'Affiliation': ''}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Dhar', 'Affiliation': ''}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'de Wit', 'Affiliation': ''}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Mason', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Goodwin', 'Affiliation': ''}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Hall', 'Affiliation': ''}, {'ForeName': 'Abbey', 'Initials': 'A', 'LastName': 'Grady', 'Affiliation': ''}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Chamberlain', 'Affiliation': ''}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Bledsoe', 'Affiliation': ''}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Leither', 'Affiliation': ''}, {'ForeName': 'Ithan', 'Initials': 'I', 'LastName': 'Peltan', 'Affiliation': ''}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Starr', 'Affiliation': ''}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Fergus', 'Affiliation': ''}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Aston', 'Affiliation': ''}, {'ForeName': 'Quinn', 'Initials': 'Q', 'LastName': 'Montgomery', 'Affiliation': ''}, {'ForeName': 'Rilee', 'Initials': 'R', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Mardee', 'Initials': 'M', 'LastName': 'Merrill', 'Affiliation': ''}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Armbruster', 'Affiliation': ''}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Harris', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Middleton', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Paine', 'Affiliation': ''}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Macy', 'Initials': 'M', 'LastName': 'Barrios', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Eppensteiner', 'Affiliation': ''}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Limkakeng', 'Affiliation': ''}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'McGowan', 'Affiliation': ''}, {'ForeName': 'Tedra', 'Initials': 'T', 'LastName': 'Porter', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bouffler', 'Affiliation': ''}, {'ForeName': 'J. Clancy', 'Initials': 'JC', 'LastName': 'Leahy', 'Affiliation': ''}, {'ForeName': 'Bennet', 'Initials': 'B', 'LastName': 'deBoisblanc', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Lammi', 'Affiliation': ''}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Happel', 'Affiliation': ''}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Lauto', 'Affiliation': ''}, {'ForeName': 'Wesley', 'Initials': 'W', 'LastName': 'Self', 'Affiliation': ''}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Casey', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Semler', 'Affiliation': ''}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Collins', 'Affiliation': ''}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Harrell', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lindsell', 'Affiliation': ''}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Rice', 'Affiliation': ''}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Stubblefield', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Gray', 'Affiliation': ''}, {'ForeName': 'Jakea', 'Initials': 'J', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Roth', 'Affiliation': ''}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Hays', 'Affiliation': ''}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Torr', 'Affiliation': ''}, {'ForeName': 'Arwa', 'Initials': 'A', 'LastName': 'Zakaria', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schoenfeld', 'Affiliation': ''}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Thompson', 'Affiliation': ''}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Hayden', 'Affiliation': ''}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Ringwood', 'Affiliation': ''}, {'ForeName': 'Cathryn', 'Initials': 'C', 'LastName': 'Oldmixon', 'Affiliation': ''}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Ulysse', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Morse', 'Affiliation': ''}, {'ForeName': 'Ariela', 'Initials': 'A', 'LastName': 'Muzikansky', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Fitzgerald', 'Affiliation': ''}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Whitaker', 'Affiliation': ''}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Lagakos', 'Affiliation': ''}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Brower', 'Affiliation': ''}, {'ForeName': 'Lora', 'Initials': 'L', 'LastName': 'Reineck', 'Affiliation': ''}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Aggarwal', 'Affiliation': ''}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Bienstock', 'Affiliation': ''}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Freemer', 'Affiliation': ''}, {'ForeName': 'Myron', 'Initials': 'M', 'LastName': 'Maclawiw', 'Affiliation': ''}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Weinmann', 'Affiliation': ''}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Morrison', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Gillespie', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kryscio', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Brodie', 'Affiliation': ''}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Zareba', 'Affiliation': ''}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Rompalo', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Boeckh', 'Affiliation': ''}, {'ForeName': 'Polly', 'Initials': 'P', 'LastName': 'Parsons', 'Affiliation': ''}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Christie', 'Affiliation': ''}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Hall', 'Affiliation': ''}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Horton', 'Affiliation': ''}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Zoloth', 'Affiliation': ''}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Dickert', 'Affiliation': ''}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Diercks', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.22240'] 1006,33189414,"Effectiveness of the PROMUFRA program in pre-frail, community-dwelling older people: A randomized controlled trial.","This study evaluated the effect of PROMUFRA program on physical frailty, kinanthropometric, muscle function and functional performance variables in pre-frail, community-dwelling older people. Participants (n = 50, 75 ± 7 years) were randomly assigned to two groups: intervention group (IG), and control group (CG). The IG performed multi-component exercise program, focused on high-intensity resistance training (HIRT) combined with self-massage for myofascial release (SMMR) for 12 weeks (2 d.wk -1 ). Two measurements were performed, at baseline and post-3 months. Participants (n = 43) were analyzed and significant differences were found in group-time interaction for muscle mass (p = 0.017), fat mass (p = 0.003), skeletal muscle mass index (p = 0.011), maximum isometric knee extension (p = 0.042), maximum dynamic knee extension (p = 0.001), maximum leg press (p < 0.001), Barthel Index (p = 0.039) and EuroQol 5-dimensions-3-levels (p = 0.012). We conclude that PROMUFRA program is an effective training method to achieve healthy improvements for the pre-frail community.",2021,"Participants (n = 43) were analyzed and significant differences were found in group-time interaction for muscle mass (p = 0.017), fat mass (p = 0.003), skeletal muscle mass index (p = 0.011), maximum isometric knee extension (p = 0.042), maximum dynamic knee extension (p = 0.001), maximum leg press (p < 0.001), Barthel Index (p = 0.039) and EuroQol 5-dimensions-3-levels (p = 0.012).","['50, 75\xa0±\xa07 years', 'Participants (n\xa0', 'pre-frail, community-dwelling older people']","['PROMUFRA program', 'intervention group (IG), and control group (CG', 'high-intensity resistance training (HIRT) combined with self-massage']","['maximum isometric knee extension', 'maximum dynamic knee extension', 'maximum leg press', 'skeletal muscle mass index', 'Barthel Index', 'EuroQol 5-dimensions-3-levels', 'physical frailty, kinanthropometric, muscle function and functional performance variables']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",43.0,0.0435037,"Participants (n = 43) were analyzed and significant differences were found in group-time interaction for muscle mass (p = 0.017), fat mass (p = 0.003), skeletal muscle mass index (p = 0.011), maximum isometric knee extension (p = 0.042), maximum dynamic knee extension (p = 0.001), maximum leg press (p < 0.001), Barthel Index (p = 0.039) and EuroQol 5-dimensions-3-levels (p = 0.012).","[{'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Barrachina-Igual', 'Affiliation': 'Doctoral School, Universidad Católica de Valencia San Vicente Mártir, C/ Ramiro de Maeztu, 14, 46900, Torrente, Valencia, Spain.'}, {'ForeName': 'Francisco M', 'Initials': 'FM', 'LastName': 'Martínez-Arnau', 'Affiliation': 'Department of Physiotherapy, Universitat de Valencia, C/ Ramiro de Maeztu, 14, 46900, Torrente, Valencia, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Pérez-Ros', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Podiatry, Universitat de Valencia, C/ Ramiro de Maeztu, 14, 46900, Torrente, Valencia, Spain; Nursing Department, Universidad Católica de Valencia San Vicente Mártir, C/ Ramiro de Maeztu, 14, 46900, Torrente, Valencia, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Flor-Rufino', 'Affiliation': 'Department of Physiotherapy, Universitat de Valencia, C/ Ramiro de Maeztu, 14, 46900, Torrente, Valencia, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Sanz-Requena', 'Affiliation': 'Radiology Department, Hospital Quironsalud Valencia, C/ Ramiro de Maeztu, 14, 46900, Torrente, Valencia, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Pablos', 'Affiliation': 'Department of Physical Activity and Sport Sciences, Universidad Católica de Valencia San Vicente Mártir, C/ Ramiro de Maeztu, 14, 46900, Torrente, Valencia, Spain. Electronic address: ana.pablos@ucv.es.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2020.10.014'] 1007,33200660,Effects of scanning parameters reduction in dental radiographs on image quality and diagnostic performance: A randomised controlled trial.,"OBJECTIVES To investigate the effect of reducing scanning parameters of digital dental panoramic tomogram (DPT) and lateral cephalometric (LC) radiographs on quality and diagnostic performance of the images. DESIGN Single-centre prospective two-arm parallel randomised controlled trial. SETTING Orthodontic Clinic, Faculty of Dentistry, Universiti Teknologi MARA, Selangor, Malaysia. PARTICIPANTS Adult orthodontic patients aged 18-35 years, indicated for DPT and LC, who were fit and healthy with a body mass index of 18.5-25.0, not contraindicated to radiographic examination, not pregnant, and did not have a history of facial or skeletal abnormalities or bone diseases were included. METHODS Thirty-eight adult orthodontic patients were randomised into control and intervention groups. DPT and LC radiographs in the control group were obtained using standard scanning parameters as prescribed by the manufacturer using Orthopantomograph® OP300 by Instrumentarium. Scanning parameters in the intervention group were reduced by 60% for DPT (60 kV, 3.2 mA) and 30% for LC (85 kV, 8 mA). A five-point rating scale was used for the assessment of image quality. Images were evaluated for diagnostic performance by detection of anatomical landmarks. Mann-Whitney test was performed to compare the quality and diagnostic performance of the images and the observer agreement was assessed using the intraclass correlation coefficient (ICC). RESULTS For image quality, the control group produced slightly lower median scores (DPT 2.0, LC 2.0) compared to the intervention group (DPT 2.0, LC 3.0). For diagnostic performance, both groups showed similar median scores (DPT 21.0, LC 32.0). The differences between control and intervention groups for both modalities were not statistically significant. The average scores for intra-observer agreement were excellent (ICC 0.917) and inter-observer agreement was good (ICC 0.822). CONCLUSION Minimising radiation exposure by reducing scanning parameters on digital DPT by 60% and LC by 30% on Intsrumentarium 300 OP did not affect the quality and diagnostic performance of the images. Thus, scanning parameters on digital DPT and LC should be reduced when taking radiographs.",2021,"RESULTS For image quality, the control group produced slightly lower median scores (DPT 2.0, LC 2.0) compared to the intervention group (DPT 2.0, LC 3.0).","['Orthodontic Clinic, Faculty of Dentistry, Universiti Teknologi MARA, Selangor, Malaysia', 'Adult orthodontic patients aged 18-35 years, indicated for DPT and LC, who were fit and healthy with a body mass index of 18.5-25.0, not contraindicated to radiographic examination, not pregnant, and did not have a history of facial or skeletal abnormalities or bone diseases were included', 'Thirty-eight adult orthodontic patients']",['digital dental panoramic tomogram (DPT) and lateral cephalometric (LC) radiographs'],"['intraclass correlation coefficient (ICC', 'median scores', 'image quality and diagnostic performance', 'DPT and LC radiographs', 'quality and diagnostic performance']","[{'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0011438', 'cui_str': 'Dentistry'}, {'cui': 'C0324975', 'cui_str': 'Dolichotis patagonum'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0442258', 'cui_str': 'Dental panoramic'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517611', 'cui_str': '18.5'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0232973', 'cui_str': 'Not pregnant'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0005940', 'cui_str': 'Disorder of bone'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0450361', 'cui_str': '38'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0442258', 'cui_str': 'Dental panoramic'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}]","[{'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0442258', 'cui_str': 'Dental panoramic'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}]",38.0,0.0632392,"RESULTS For image quality, the control group produced slightly lower median scores (DPT 2.0, LC 2.0) compared to the intervention group (DPT 2.0, LC 3.0).","[{'ForeName': 'Liyana', 'Initials': 'L', 'LastName': 'Ghazali', 'Affiliation': 'Centre for Paediatric Dentistry and Orthodontic Studies, Faculty of Dentistry, Universiti Teknologi MARA, Sungai Buloh, Selangor, Malaysia.'}, {'ForeName': 'Mohd Yusmiaidil Putera', 'Initials': 'MYP', 'LastName': 'Mohd Yusof', 'Affiliation': 'Centre for Oral and Maxillofacial Diagnostics and Medicine Studies, Faculty of Dentistry, Universiti Teknologi MARA, Sungai Buloh, Selangor, Malaysia.'}, {'ForeName': 'Noraina Hafizan', 'Initials': 'NH', 'LastName': 'Norman', 'Affiliation': 'Centre for Paediatric Dentistry and Orthodontic Studies, Faculty of Dentistry, Universiti Teknologi MARA, Sungai Buloh, Selangor, Malaysia.'}]",Journal of orthodontics,['10.1177/1465312520971641'] 1008,33200772,Comparative effects of telephone versus in-office behavioral counseling to improve HIV treatment outcomes among people living with HIV in a rural setting.,"With the expansion of telehealth services, there is a need for evidence-based treatment adherence interventions that can be delivered remotely to people living with HIV. Evidence-based behavioral health counseling can be delivered via telephone, as well as in-office services. However, there is limited research on counseling delivery formats and their differential outcomes. The purpose of this study was to conduct a head-to-head comparison of behavioral self-regulation counseling delivered by telephone versus behavioral self-regulation counseling delivered by in-office sessions to improve HIV treatment outcomes. Patients (N = 251) deemed at risk for discontinuing care and treatment failure living in a rural area of the southeastern USA were referred by their care provider. The trial implemented a Wennberg Randomized Preferential Design to rigorously test: (a) patient preference and (b) comparative effects on patient retention in care and treatment adherence. There was a clear patient preference for telephone-delivered counseling (69%) over in-office-delivered counseling (31%) and participants who received telephone counseling completed a greater number of sessions. There were few differences between the two intervention delivery formats on clinical appointment attendance, antiretroviral adherence, and HIV viral load. Overall improvements in health outcomes were not observed across delivery formats. Telephone-delivered counseling did show somewhat greater benefit for improving depression symptoms, whereas in-office services demonstrated greater benefits for reducing alcohol use. These results encourage offering most patients the choice of telephone and in-office behavioral health counseling and suggest that more intensive interventions may be needed to improve clinical outcomes for people living with HIV who may be at risk for discontinuing care or experiencing HIV treatment failure.",2021,"There were few differences between the two intervention delivery formats on clinical appointment attendance, antiretroviral adherence, and HIV viral load.","['people living with HIV in a rural setting', 'Patients (N = 251) deemed at risk for discontinuing care and treatment failure living in a rural area of the southeastern USA were referred by their care provider', 'people living with HIV who may be at risk for discontinuing care or experiencing HIV treatment failure']","['Telephone-delivered counseling', 'telephone versus in-office behavioral counseling', 'telephone counseling', 'behavioral self-regulation counseling delivered by telephone versus behavioral self-regulation counseling']","['health outcomes', 'depression symptoms', 'clinical appointment attendance, antiretroviral adherence, and HIV viral load', 'HIV treatment outcomes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0553514', 'cui_str': 'Referral source'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",251.0,0.0756517,"There were few differences between the two intervention delivery formats on clinical appointment attendance, antiretroviral adherence, and HIV viral load.","[{'ForeName': 'Seth C', 'Initials': 'SC', 'LastName': 'Kalichman', 'Affiliation': 'Institute for Collaboration on Health Intervention and Policy, University of Connecticut, Storrs, CT, USA.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Katner', 'Affiliation': 'Department of Medicine, Mercer University Medical School, Macon, GA, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Eaton', 'Affiliation': 'Institute for Collaboration on Health Intervention and Policy, University of Connecticut, Storrs, CT, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Banas', 'Affiliation': 'Department of Medicine, Mercer University Medical School, Macon, GA, USA.'}, {'ForeName': 'Marnie', 'Initials': 'M', 'LastName': 'Hill', 'Affiliation': 'Department of Medicine, Mercer University Medical School, Macon, GA, USA.'}, {'ForeName': 'Moira O', 'Initials': 'MO', 'LastName': 'Kalichman', 'Affiliation': 'Institute for Collaboration on Health Intervention and Policy, University of Connecticut, Storrs, CT, USA.'}]",Translational behavioral medicine,['10.1093/tbm/ibaa109'] 1009,33201119,Two Year Outcomes of Prehabilitation Among Obese Patients with Ventral Hernias: A Randomized Controlled Trial (NCT02365194).,"OBJECTIVE To determine if preoperative nutritional counseling and exercise (prehabilitation) improve outcomes in obese patients seeking ventral hernia repair (VHR)? SUMMARY BACKGROUND DATA Obesity and poor fitness are associated with complications following VHR. It is unknown if preoperative prehabilitation improves outcomes of obese patients seeking VHR. METHODS This is the 2-year follow-up of a blinded randomized controlled trial from 2015-2017 at a safety-net academic institution. Obese patients(BMI 30-40) seeking VHR were randomized to prehabilitation versus standard counseling. Elective VHR was performed once preoperative requirements were met: 7% total body weight loss or 6 months of counseling and no weight gain. Primary outcome was percentage of hernia-free and complication-free patients at 2-years. Complications included recurrence, re-operation, and mesh complications. Primary outcome was compared using chi-square. We hypothesize that prehabilitation in obese patients with VHR results in more hernia- and complication-free patients at 2-years. RESULTS Of the 118 randomized patients, 108(91.5%) completed a median(range) follow-up of 27.3(6.2-37.4) months. Baseline BMI (mean±SD) was similar between groups (36.8 ± 2.6 vs 37.0 ± 2.6). More patients in the prehabilitation group underwent emergency surgery (5 vs 1) or dropped out of the program (3 vs 1) compared to standard counseling (13.6% vs 3.4%, p = 0.094). Among patients who underwent surgery, there was no difference in major complications (10.2% vs 9.1%, p = 0.438). At 2-years, there was no difference in percentage of hernia-free and complication-free patients (72.9% versus 66.1%, p = 0.424, 1.14, 0.88-1.47). CONCLUSION There is no difference in 2-year outcomes of obese patients seeking VHR who undergo prehabilitation versus standard care. Prehabilitation may not be warranted in obese patients undergoing elective VHR. CLINICAL TRIAL REGISTRATION This trial was registered with clinicaltrials.gov (NCT02365194)Conflict of Interest and Source of Funding: This work was supported by grants awarded to Dr. Liang from the Center for Clinical and Translational Sciences [grant number UL1 TR000370] and the National Center for Advancing Translational Sciences [grant number KL2 TR000370]. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research or the National Institute of Health. The remaining authors have nothing to disclose. FUNDING Grants from the Center for Clinical and Translational Sciences [UL1 TR000370] and the National Center for Advancing Translational Sciences [KL2 TR000370].",2020,There is no difference in 2-year outcomes of obese patients seeking VHR who undergo prehabilitation versus standard care.,"['obese patients undergoing elective VHR', 'obese patients seeking ventral hernia repair (VHR', 'obese patients with VHR', 'obese patients seeking VHR', 'Obese patients(BMI 30-40) seeking VHR', '2015-2017 at a safety-net academic institution', 'Obese Patients with Ventral Hernias']","['preoperative nutritional counseling and exercise (prehabilitation', 'Prehabilitation', 'prehabilitation versus standard counseling', 'Elective VHR']","['emergency surgery', 'percentage of hernia-free and complication-free patients at 2-years', 'recurrence, re-operation, and mesh complications', 'Baseline BMI (mean±SD', 'major complications', 'percentage of hernia-free and complication']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0019334', 'cui_str': 'Repair of ventral hernia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0019326', 'cui_str': 'Hernia of anterior abdominal wall'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C5192101', 'cui_str': 'Prehabilitation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0019334', 'cui_str': 'Repair of ventral hernia'}]","[{'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",118.0,0.215257,There is no difference in 2-year outcomes of obese patients seeking VHR who undergo prehabilitation versus standard care.,"[{'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Bernardi', 'Affiliation': 'Surgery Department, McGovern Medical School at the University of Texas Health Science Center Houston, (Houston, TX).'}, {'ForeName': 'Oscar A', 'Initials': 'OA', 'LastName': 'Olavarria', 'Affiliation': 'Surgery Department, McGovern Medical School at the University of Texas Health Science Center Houston, (Houston, TX).'}, {'ForeName': 'Naila H', 'Initials': 'NH', 'LastName': 'Dhanani', 'Affiliation': 'Surgery Department, McGovern Medical School at the University of Texas Health Science Center Houston, (Houston, TX).'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Lyons', 'Affiliation': 'Surgery Department, McGovern Medical School at the University of Texas Health Science Center Houston, (Houston, TX).'}, {'ForeName': 'Julie L', 'Initials': 'JL', 'LastName': 'Holihan', 'Affiliation': 'Surgery Department, McGovern Medical School at the University of Texas Health Science Center Houston, (Houston, TX).'}, {'ForeName': 'Deepa V', 'Initials': 'DV', 'LastName': 'Cherla', 'Affiliation': 'Surgery Department, McGovern Medical School at the University of Texas Health Science Center Houston, (Houston, TX).'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Berger', 'Affiliation': 'Surgery Department, Baylor Medical School (Houston, TX).'}, {'ForeName': 'Tien C', 'Initials': 'TC', 'LastName': 'Ko', 'Affiliation': 'Surgery Department, McGovern Medical School at the University of Texas Health Science Center Houston, (Houston, TX).'}, {'ForeName': 'Lillian S', 'Initials': 'LS', 'LastName': 'Kao', 'Affiliation': 'Surgery Department, McGovern Medical School at the University of Texas Health Science Center Houston, (Houston, TX).'}, {'ForeName': 'Mike K', 'Initials': 'MK', 'LastName': 'Liang', 'Affiliation': 'Surgery Department, McGovern Medical School at the University of Texas Health Science Center Houston, (Houston, TX).'}]",Annals of surgery,['10.1097/SLA.0000000000004486'] 1010,33196606,Acute Running and Coronary Heart Disease Risk Markers in Male Cigarette Smokers and Nonsmokers: A Randomized Crossover Trial.,"PURPOSE Cigarette smoking is an independent risk factor for coronary heart disease and is associated with impaired postprandial metabolism. Acute exercise reduces postprandial lipemia and improves other coronary heart disease risk markers in nonsmokers. Less is known about responses in cigarette smokers. METHODS Twelve male cigarette smokers (mean ± SD; age = 23 ± 4 yr, body mass index = 24.9 ± 3.0 kg·m-2) and 12 male nonsmokers (age = 24 ± 4 yr, body mass index = 24.1 ± 2.0 kg·m-2) completed two, 2-d conditions (control and exercise) in a randomized crossover design. On day 1, participants rested for 9 h (0800-1700) in both conditions except a 60-min treadmill run (65% ± 7% peak oxygen uptake, 2.87 ± 0.54 MJ) was completed between 6.5 and 7.5 h (1430-1530) in the exercise condition. On day 2 of both conditions, participants rested and consumed two high-fat meals over 8 h (0900-1700) during which 13 venous blood samples and nine resting arterial blood pressure measurements were collected. RESULTS Smokers exhibited higher postprandial triacylglycerol and C-reactive protein than nonsmokers (main effect group effect size [Cohen's d] ≥ 0.94, P ≤ 0.034). Previous day running reduced postprandial triacylglycerol, insulin, and systolic and diastolic blood pressure (main effect condition d ≥ 0.28, P ≤ 0.044) and elevated postprandial nonesterified fatty acid and C-reactive protein (main effect condition d ≥ 0.41, P ≤ 0.044). Group-condition interactions were not apparent for any outcome across the total postprandial period (0-8 h; all P ≥ 0.089), but the exercise-induced reduction in postprandial triacylglycerol in the early postprandial period (0-4 h) was greater in nonsmokers than smokers (-21%, d = 0.43, vs -5%, d = 0.16, respectively; group-condition interaction P = 0.061). CONCLUSIONS Acute moderate-intensity running reduced postprandial triacylglycerol, insulin, and resting arterial blood pressure the day after exercise in male cigarette smokers and nonsmokers. These findings highlight the ability of acute exercise to augment the postprandial metabolic health of cigarette smokers and nonsmokers.",2021,"RESULTS Smokers exhibited higher postprandial triacylglycerol and C-reactive protein than non-smokers (main effect group effect size (Cohen's d)≥0.94, P≤0.034).","['age 23(4) years, BMI 24.9(3.0) kg/m) and 12 male non-smokers (24(4) years, 24.1(2.0) kg/m) completed two, 2-day conditions (control, exercise', 'male cigarette smokers and non-smokers', 'Male Cigarette Smokers and Nonsmokers', 'non-smokers', 'Twelve male cigarette smokers (mean(SD']","['Acute exercise', 'Acute Running and Coronary Heart Disease Risk Markers']","['postprandial metabolic health', 'postprandial triacylglycerol, insulin and systolic and diastolic blood pressure', 'postprandial triacylglycerol, insulin and resting arterial blood pressure', 'elevated postprandial non-esterified fatty acid and C-reactive protein', 'postprandial triacylglycerol', 'postprandial triacylglycerol and C-reactive protein', 'total postprandial period', 'CHD risk markers']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}]","[{'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C1277690', 'cui_str': 'Coronary heart disease risk'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1272641', 'cui_str': 'Systemic arterial pressure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1277690', 'cui_str': 'Coronary heart disease risk'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",12.0,0.0232111,"RESULTS Smokers exhibited higher postprandial triacylglycerol and C-reactive protein than non-smokers (main effect group effect size (Cohen's d)≥0.94, P≤0.034).","[{'ForeName': 'Tareq F', 'Initials': 'TF', 'LastName': 'Alotaibi', 'Affiliation': ''}, {'ForeName': 'Alice E', 'Initials': 'AE', 'LastName': 'Thackray', 'Affiliation': ''}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Roberts', 'Affiliation': ''}, {'ForeName': 'Turki M', 'Initials': 'TM', 'LastName': 'Alanazi', 'Affiliation': ''}, {'ForeName': 'Nicolette C', 'Initials': 'NC', 'LastName': 'Bishop', 'Affiliation': ''}, {'ForeName': 'Alex J', 'Initials': 'AJ', 'LastName': 'Wadley', 'Affiliation': ''}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'King', 'Affiliation': ''}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': ""O'Donnell"", 'Affiliation': 'School of Sport, Exercise and Health Sciences, National Centre for Sport and Exercise Medicine, Loughborough University, Loughborough, UNITED KINGDOM.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Steiner', 'Affiliation': ''}, {'ForeName': 'Sally J', 'Initials': 'SJ', 'LastName': 'Singh', 'Affiliation': ''}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Stensel', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002560'] 1011,33136770,Higher Peak Fat Oxidation During Rowing vs. Cycling in Active Men and Women.,"ABSTRACT Astorino, TA, Oriente, C, Peterson, J, Alberto, G, Castillo, EE, Vasquez-Soto, U, Ibarra, E, Guise, V, Castaneda, I, Marroquin, JR, Dargis, R, and Thum, JS. Higher peak fat oxidation during rowing vs. cycling in active men and women. J Strength Cond Res 35(1): 9-15, 2021-This study compared fat and carbohydrate oxidation (CHOOx) between progressive rowing and cycling. Initially, 22 active healthy adults (age = 27 ± 8 years) performed incremental cycling and rowing to volitional fatigue to assess maximal oxygen uptake (V̇o2max) and maximal heart rate (HRmax). The order of 2 subsequent sessions was randomized, performed 2 hours postmeal, and included a warm-up followed by three 8-minute stages of rowing or cycling at 60-65, 70-75, and 80-85 %HRmax. During exercise, power output was modified to maintain work rate in the desired range. Gas exchange data and blood samples were obtained to measure fat and CHOOx and blood lactate concentration. Fat oxidation (FOx) increased during exercise (p < 0.001) and there was a main effect of mode (p = 0.03) but no modeXintensity interaction (p = 0.33). Peak FOx was higher in response to rowing vs. cycling (0.23 ± 0.09 g·min-1 vs. 0.18 ± 0.07 g·min-1, p = 0.01). Carbohydrate oxidation increased during exercise (p < 0.001) but there was no effect of mode (p = 0.25) or modeXintensity interaction (p = 0.08). Blood lactate concentration was lower (p = 0.007) at the end of rowing vs. cycling (3.1 ± 1.0 mM vs. 3.9 ± 1.6 mM, d = 1.1). Prolonged rowing having equivalent calorie expenditure and intensity vs. cycling elicits higher peak FOx, which is likely attributed to greater muscle mass used during rowing.",2021,Fat oxidation (FOx) increased during exercise (p < 0.001) and there was a main effect of mode (p = 0.03) but no modeXintensity interaction (p = 0.33).,"['22 active healthy adults (age = 27 ± 8 years) performed', 'active men and women', 'Active Men and Women']","['fat and carbohydrate oxidation (CHOOx) between progressive rowing and cycling', 'incremental cycling and rowing to volitional fatigue to assess maximal oxygen uptake ', 'V[Combining']","['maximal heart rate (HRmax', 'Astorino, TA, Oriente, C, Peterson, J, Alberto, G, Castillo, EE, Vasquez-Soto, U, Ibarra, E, Guise, V, Castaneda, I, Marroquin, JR, Dargis, R, and Thum, JS', 'Fat oxidation (FOx', 'Higher peak fat oxidation', 'Higher Peak Fat Oxidation', 'Blood lactate concentration', 'Carbohydrate oxidation', 'fat and CHOOx and blood lactate concentration', 'Peak FOx']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}]",22.0,0.0690565,Fat oxidation (FOx) increased during exercise (p < 0.001) and there was a main effect of mode (p = 0.03) but no modeXintensity interaction (p = 0.33).,"[{'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Astorino', 'Affiliation': 'Department of Kinesiology, California State University, San Marcos, California.'}, {'ForeName': 'Chandler', 'Initials': 'C', 'LastName': 'Oriente', 'Affiliation': ''}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Peterson', 'Affiliation': ''}, {'ForeName': 'Giannina', 'Initials': 'G', 'LastName': 'Alberto', 'Affiliation': ''}, {'ForeName': 'Erica Elena', 'Initials': 'EE', 'LastName': 'Castillo', 'Affiliation': ''}, {'ForeName': 'Ulices', 'Initials': 'U', 'LastName': 'Vasquez-Soto', 'Affiliation': ''}, {'ForeName': 'Esmerelda', 'Initials': 'E', 'LastName': 'Ibarra', 'Affiliation': ''}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Guise', 'Affiliation': ''}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Castaneda', 'Affiliation': ''}, {'ForeName': 'Joel R', 'Initials': 'JR', 'LastName': 'Marroquin', 'Affiliation': ''}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Dargis', 'Affiliation': ''}, {'ForeName': 'Jacob S', 'Initials': 'JS', 'LastName': 'Thum', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003888'] 1012,33138061,"Whey Protein Drink Ingestion before Breakfast Suppressed Energy Intake at Breakfast and Lunch, but Not during Dinner, and Was Less Suppressed in Healthy Older than Younger Men.","Ageing is associated with changes in feeding behavior. We have reported that there is suppression of energy intake three hours after whey protein drink ingestion in young, but not older, men. This study aimed to determine these effects over a time period of 9 h. Fifteen younger (27 ± 1 years, 25.8 ± 0.7 kg/m 2 ) and 15 older (75 ± 2 years, 26.6 ± 0.8 kg/m 2 ) healthy men were studied on three occasions on which they received, in a randomized order, a 30 g/120 kcal, 70 g/280 kcal whey-protein, or control (~2 kcal) drink. Ad-libitum energy intake (sum of breakfast, lunch, and dinner) was suppressed in a protein load responsive fashion ( P = 0.001). Suppression was minimal at breakfast, substantial at lunch (~-16%, P = 0.001), no longer present by dinner, and was less in older than younger men (-3 ± 4% vs. -8 ± 4%, P = 0.027). Cumulative protein intake was increased in the younger and older men (+20% and +42%, P < 0.001). Visual analogue scale ratings of fullness were higher and desire to eat and prospective food consumption were lower after protein vs. control, and these effects were smaller in older vs. younger men (interaction effect P < 0.05). These findings support the use of whey-protein drink supplements in older people who aim to increase their protein intake without decreasing their overall energy intake.",2020,"Suppression was minimal at breakfast, substantial at lunch (~-16%, P = 0.001), no longer present by dinner, and was less in older than younger men (-3 ± 4% vs. -8 ± 4%, P = 0.027).","['9 h. Fifteen younger (27 ± 1 years, 25.8 ± 0.7 kg/m 2 ) and 15 older (75 ± 2 years, 26.6 ± 0.8 kg/m 2 ) healthy men', 'Healthy Older than Younger Men', 'older people']",[],"['desire to eat and prospective food consumption', 'Suppression', 'Cumulative protein intake', 'Visual analogue scale ratings of fullness']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}]",,0.0421774,"Suppression was minimal at breakfast, substantial at lunch (~-16%, P = 0.001), no longer present by dinner, and was less in older than younger men (-3 ± 4% vs. -8 ± 4%, P = 0.027).","[{'ForeName': 'Avneet', 'Initials': 'A', 'LastName': 'Oberoi', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Royal Adelaide Hospital, Adelaide, SA 5000, South-Australia, Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Giezenaar', 'Affiliation': 'Riddet Institute, Massey University, Palmerston North 9430, New Zealand.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Clames', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Royal Adelaide Hospital, Adelaide, SA 5000, South-Australia, Australia.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Bøhler', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Royal Adelaide Hospital, Adelaide, SA 5000, South-Australia, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Lange', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Royal Adelaide Hospital, Adelaide, SA 5000, South-Australia, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Royal Adelaide Hospital, Adelaide, SA 5000, South-Australia, Australia.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Jones', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Royal Adelaide Hospital, Adelaide, SA 5000, South-Australia, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Chapman', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Royal Adelaide Hospital, Adelaide, SA 5000, South-Australia, Australia.'}, {'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Soenen', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Royal Adelaide Hospital, Adelaide, SA 5000, South-Australia, Australia.'}]",Nutrients,['10.3390/nu12113318'] 1013,33141327,"Impact of a school-based water, sanitation and hygiene programme on children's independent handwashing and toothbrushing habits: a cluster-randomised trial.","OBJECTIVES To explore whether a school-based water, sanitation and hygiene programme, which includes group hygiene activities, contributes to the formation of independent handwashing and toothbrushing habits among Filipino children. METHODS In this cluster-randomised trial, twenty primary schools were randomly allocated to the intervention or control arm. Intervention schools received group handwashing facilities and implemented daily group handwashing and toothbrushing activities. A soap use to toilet event ratio was calculated to measure children's independent handwashing behaviour after toilet use, and dental plaque accumulation on Monday morning was measured as a proxy indicator for children's independent toothbrushing behaviour at home. RESULTS Four months after implementation, handwashing and toothbrushing behaviours did not significantly differ between intervention and control schools. The mean soap use in intervention schools and control schools was 0.41 g and 0.30 g per toilet event, respectively (p = 0.637). Compared to baseline, mean plaque scores reduced by 4.2% and 3.5% in intervention and control schools, respectively (p = 0.857). CONCLUSIONS Although health benefits have been established, school-based group handwashing and toothbrushing may not be sufficient to increase children's uptake of independent hygiene behaviours.",2020,"Compared to baseline, mean plaque scores reduced by 4.2% and 3.5% in intervention and control schools, respectively (p = 0.857). ","['twenty primary schools', ""children's independent handwashing and toothbrushing habits""]","['school-based water, sanitation and hygiene programme', 'group handwashing facilities and implemented daily group handwashing and toothbrushing activities']","['handwashing and toothbrushing behaviours', 'mean plaque scores']","[{'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",20.0,0.0493894,"Compared to baseline, mean plaque scores reduced by 4.2% and 3.5% in intervention and control schools, respectively (p = 0.857). ","[{'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Duijster', 'Affiliation': 'Department of Social Dentistry, Academic Centre for Dentistry Amsterdam, University of Amsterdam and VU Universiteit Amsterdam, Amsterdam, The Netherlands. D.Duijster@acta.nl.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Buxton', 'Affiliation': 'Disease Control Department, School of Hygiene and Tropical Medicine London, London, UK.'}, {'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Benzian', 'Affiliation': 'Department of Epidemiology and Health Promotion, WHO Collaborating Center for Quality Improvement and Evidence-based Dentistry, College of Dentistry, New York University, New York, USA.'}, {'ForeName': 'Jed', 'Initials': 'J', 'LastName': 'Dimaisip-Nabuab', 'Affiliation': 'Gesellschaft für Internationale Zusammenarbeit (GIZ), Metro Manila, Philippines.'}, {'ForeName': 'Bella', 'Initials': 'B', 'LastName': 'Monse', 'Affiliation': 'Gesellschaft für Internationale Zusammenarbeit (GIZ), Metro Manila, Philippines.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Volgenant', 'Affiliation': 'Department of Preventive Dentistry, Academic Centre for Dentistry Amsterdam, University of Amsterdam and VU Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Dreibelbis', 'Affiliation': 'Disease Control Department, School of Hygiene and Tropical Medicine London, London, UK.'}]",International journal of public health,['10.1007/s00038-020-01514-z'] 1014,33141477,A Comparison of Triamcinolone Acetonide Econazole Cream and Nystatin Suspension in Treatment of Otomycosis.,"OBJECTIVES/HYPOTHESIS To compare the efficacy and adverse effects of triamcinolone acetonide econazole cream and nystatin suspension in the treatment of otomycosis, and to determine the clinical features, predisposing factors, and etiology of otomycosis. STUDY DESIGN A prospective study. METHODS A prospective clinical trial was conducted on 786 patients diagnosed with otomycosis. The study population was randomly divided into two treatment groups of triamcinolone acetonide econazole cream (TAEC) and nystatin suspension in a 1:1 ratio. After clearing all fungal deposits in the external auditory canal, the antimycotic drugs were locally applied for at least 2 weeks. The efficacy and adverse effects were compared between the two antifungal reagents by statistical analysis. Meanwhile, patient clinical data were collected to find out the clinical features, predisposing factors, and etiology. RESULTS Pruritis was the most common symptom and Aspergillus niger was the leading fungal pathogen. There was high association (44.5%) of otomycosis with a history of unclean ear picking. The cure rate was 97.6% in the TAEC group and 73.5% in the nystatin group (P < .01). Treatment with TAEC resulted in 2.4% of patients complaining of discomforts (irritant dermatitis, otalgia, or headache) versus 59.8% of patients complaining discomforts treated with nystatin (P < .01). The residue rate of antifungals was 1.9% in the TAEC group and 89.9% in the nystatin group (P < .01) at the end of treatment. CONCLUSIONS Thoroughly cleaning of the external auditory canal followed by local use of TAEC under endotoscope is an effective, convenient, and well-tolerated treatment for otomycosis. LEVEL OF EVIDENCE 1 Laryngoscope, 131:E1640-E1646, 2021.",2021,The cure rate was 97.6% in the TAEC group and 73.5% in the nystatin group (P < .01).,['786 patients diagnosed with otomycosis'],"['triamcinolone acetonide econazole cream (TAEC) and nystatin suspension', 'nystatin', 'triamcinolone acetonide econazole cream and nystatin suspension', 'TAEC', 'Triamcinolone Acetonide Econazole Cream and Nystatin Suspension']","['complaining of discomforts (irritant dermatitis, otalgia, or headache', 'efficacy and adverse effects', 'cure rate', 'residue rate of antifungals']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0029895', 'cui_str': 'Otomycosis'}]","[{'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0013547', 'cui_str': 'Econazole'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0028741', 'cui_str': 'Nystatin'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}]","[{'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0162823', 'cui_str': 'Irritant contact dermatitis'}, {'cui': 'C0013456', 'cui_str': 'Otalgia'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0003308', 'cui_str': 'Antifungal-containing product'}]",786.0,0.0251331,The cure rate was 97.6% in the TAEC group and 73.5% in the nystatin group (P < .01).,"[{'ForeName': 'Qingguo', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Hanqi', 'Initials': 'H', 'LastName': 'Chu', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yanling', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Liyan', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Liangqiang', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Tianyou Hospital Affiliated to Wuhan University of Science & Technology, Wuhan, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Laboratory Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}]",The Laryngoscope,['10.1002/lary.29190'] 1015,33143203,The Impact of Micronutrient Fortified Foods on Cognitive Functioning among Low-Income Children: A Pilot and Feasibility Study.,"Brain development continues throughout childhood and requires micronutrients for optimal maturation, but studies have typically examined only a limited number of micronutrients and there has been inconsistent use of validated cognitive measures. This study evaluated the impact of providing low-income children with a daily fortified meal (570 kcal) in the form of a bar and shake containing >75% of the FDA Daily Values for all essential vitamins and minerals, as well as macronutrients (e.g., omega-3 and omega-6 fatty acids and protein), in an afterschool care setting (instead of the usual meal provided) on cognitive functioning. Students aged 8-12 were randomly assigned to intervention ( n = 19) or control ( n = 16) meals. Students completed the Stroop Color Word Task, Trail Making Test, and Conner's Continuous Performance Task (CPT) at baseline and 3 months post-intervention. Differences in cognitive scores were examined using 2 × 2 mixed model ANOVAs (Stroop and CPT) and ANCOVAs (Trail Making Test). Significant main effects of time indicated improvements in both intervention and control groups, but there were no significant main effects of group or group*time interactions. When the amount of meal consumed was examined, most results became non-significant, suggesting that overall meal consumption significantly impacted the observed results. Overall, this pilot study suggests that there may be limited additional benefits to short-term consumption of micronutrient fortified meals among low-income children in an afterschool care setting, and potential benefits observed may be directly related to the amount of food consumed.",2020,"Significant main effects of time indicated improvements in both intervention and control groups, but there were no significant main effects of group or group*time interactions.","['Low-Income Children', 'Students aged 8-12']","['Micronutrient Fortified Foods', 'daily fortified meal']","[""Stroop Color Word Task, Trail Making Test, and Conner's Continuous Performance Task (CPT"", 'Cognitive Functioning', 'overall meal consumption', 'cognitive scores']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0040604', 'cui_str': 'Trail making test'}, {'cui': 'C4329232', 'cui_str': 'AX-CPT'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0236265,"Significant main effects of time indicated improvements in both intervention and control groups, but there were no significant main effects of group or group*time interactions.","[{'ForeName': 'Juliana F W', 'Initials': 'JFW', 'LastName': 'Cohen', 'Affiliation': 'Department of Public Health and Nutrition, Merrimack College, 315 Turnpike Street, North Andover, MA 01845, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Sagar', 'Affiliation': 'Cognitive and Clinical Neuroimaging Core, McLean Hospital, Belmont, MA 02478, USA.'}, {'ForeName': 'Mary Kathryn', 'Initials': 'MK', 'LastName': 'Dahlgren', 'Affiliation': 'Cognitive and Clinical Neuroimaging Core, McLean Hospital, Belmont, MA 02478, USA.'}, {'ForeName': 'Laura B F', 'Initials': 'LBF', 'LastName': 'Kurdziel', 'Affiliation': 'Department of Psychology, Merrimack College, North Andover, MA 01845, USA.'}, {'ForeName': 'Staci A', 'Initials': 'SA', 'LastName': 'Gruber', 'Affiliation': 'Cognitive and Clinical Neuroimaging Core, McLean Hospital, Belmont, MA 02478, USA.'}]",Nutrients,['10.3390/nu12113351'] 1016,33143212,Effect of Phaseolus Vulgaris on Urinary Biochemical Parameters among Patients with Kidney Stones in Saudi Arabia.,"The study purpose was to investigate the effect of Phaseolus Vulgaris (PV) on urinary biochemical parameters among patients with kidney stones. We conducted a randomized controlled study among 60 patients with kidney stones (size < 10 mm) in the nephrology unit of both government and private hospitals, Al-Ahsa. Urinary volume, calcium, magnesium, potassium, oxalate, uric acid, and power of hydrogen (pH) were assessed before and after the intervention of giving 250 g of PV consumption as an extract thrice weekly (2.2 L to 2.5 L per week) for 6 weeks, which was compared with control. A 't' test was used with the significance at 5%. Mean score of age was 44.5 ± 10.16 in PV group and 43.73 ± 9.79 in control. Four (13.3%) and two (6.7%) had family history of kidney stones. Body mass Index (BMI) mean was 26.44 ± 2.7 and 26.36 ± 2.65 in pre and post-test, respectively, which were significant ( p = 0.01017). There were significant changes ( p = 0.000) in urine volume from 1962 ± 152.8 to 2005 ± 148.8, calcium 205.4 ± 11.99 to 198.4 ± 12.52, potassium 44.07 ± 3.66 to 52.15 ± 4.37, oxalate 37.12 ± 5.38 to 33.02 ± 5.71, and uric acid 6.88 ± 0.7 to 6.31 ± 0.58. In conclusion, PV is effective management for the patients with kidney stones as it increases the urinary volume and enhances the elimination of small kidney stones.",2020,"There were significant changes ( p = 0.000) in urine volume from 1962 ± 152.8 to 2005 ± 148.8, calcium 205.4 ± 11.99 to 198.4 ± 12.52, potassium 44.07 ± 3.66 to 52.15 ± 4.37, oxalate 37.12 ± 5.38 to 33.02 ± 5.71, and uric acid 6.88 ± 0.7 to 6.31 ± 0.58.","['Patients with Kidney Stones in Saudi Arabia', '60 patients with kidney stones (size < 10 mm) in the nephrology unit of both government and private hospitals, Al-Ahsa', 'patients with kidney stones']","['Phaseolus Vulgaris', 'Phaseolus Vulgaris (PV', 'PV']","['family history of kidney stones', 'Urinary Biochemical Parameters', 'urinary biochemical parameters', 'Urinary volume, calcium, magnesium, potassium, oxalate, uric acid, and power of hydrogen (pH', 'Body mass Index (BMI) mean']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0027712', 'cui_str': 'Nephrology'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0033173', 'cui_str': 'Private hospital'}]","[{'cui': 'C0973452', 'cui_str': 'Kidney Bean'}]","[{'cui': 'C1563033', 'cui_str': 'Family history of renal stone'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0029988', 'cui_str': 'Oxalate'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",60.0,0.0544148,"There were significant changes ( p = 0.000) in urine volume from 1962 ± 152.8 to 2005 ± 148.8, calcium 205.4 ± 11.99 to 198.4 ± 12.52, potassium 44.07 ± 3.66 to 52.15 ± 4.37, oxalate 37.12 ± 5.38 to 33.02 ± 5.71, and uric acid 6.88 ± 0.7 to 6.31 ± 0.58.","[{'ForeName': 'Sahbanathul Missiriya', 'Initials': 'SM', 'LastName': 'Jalal', 'Affiliation': 'Department of Nursing, College of Applied Medical Science, King Faisal University, Al-Ahsa 31982, Saudi Arabia.'}, {'ForeName': 'Abdulrahman Abdulhadi', 'Initials': 'AA', 'LastName': 'Alsultan', 'Affiliation': 'Department of Biomedical Sciences, College of Medicine, King Faisal University, Al-Ahsa 31982, Saudi Arabia.'}, {'ForeName': 'Hala Hazam', 'Initials': 'HH', 'LastName': 'Alotaibi', 'Affiliation': 'Department of Food and Nutrition Sciences, College of Agriculture and Food Sciences, King Faisal University, Al-Ahsa 31982, Saudi Arabia.'}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Mary', 'Affiliation': 'Department of Pediatrics, King Khalid Hospital, Najran 66262, Saudi Arabia.'}, {'ForeName': 'Abeer Abbas Ibrahim', 'Initials': 'AAI', 'LastName': 'Alabdullatif', 'Affiliation': 'Department of Nursing, College of Applied Medical Science, King Faisal University, Al-Ahsa 31982, Saudi Arabia.'}]",Nutrients,['10.3390/nu12113346'] 1017,33150388,Chemotherapy or allogeneic transplantation in high-risk Philadelphia chromosome-negative adult lymphoblastic leukemia.,"The need for allogeneic hematopoietic stem cell transplantation (allo-HSCT) in adults with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) with high-risk (HR) features and adequate measurable residual disease (MRD) clearance remains unclear. The aim of the ALL-HR-11 trial was to evaluate the outcomes of HR Ph- adult ALL patients following chemotherapy or allo-HSCT administered based on end-induction and consolidation MRD levels. Patients aged 15 to 60 years with HR-ALL in complete response (CR) and MRD levels (centrally assessed by 8-color flow cytometry) <0.1% after induction and <0.01% after early consolidation were assigned to receive delayed consolidation and maintenance therapy up to 2 years in CR. The remaining patients were allocated to allo-HSCT. CR was attained in 315/348 patients (91%), with MRD <0.1% after induction in 220/289 patients (76%). By intention-to-treat, 218 patients were assigned to chemotherapy and 106 to allo-HSCT. The 5-year (±95% confidence interval) cumulative incidence of relapse (CIR), overall survival (OS), and event-free survival probabilities for the whole series were 43% ± 7%, 49% ± 7%, and 40% ± 6%, respectively, with CIR and OS rates of 45% ± 8% and 59% ± 9% for patients assigned to chemotherapy and of 40% ± 12% and 38% ± 11% for those assigned to allo-HSCT, respectively. Our results show that avoiding allo-HSCT does not hamper the outcomes of HR Ph- adult ALL patients up to 60 years with adequate MRD response after induction and consolidation. Better postremission alternative therapies are especially needed for patients with poor MRD clearance. This trial was registered at www.clinicaltrials.gov as # NCT01540812.",2021,Our results show that avoiding allo-HSCT does not hamper the outcomes of HR Ph-neg adult ALL patients up to 60y with adequate MRD response after induction and consolidation.,"['218 patients were assigned to', 'patients with poor MRD clearance', 'Patients aged 15-60 years (y) with HR-ALL in complete response (CR) and MRD levels (centrally assessed by 8-color flow cytometry) <0.1% after induction and <0.01% after early consolidation', 'adults with Philadelphia chromosome-negative (Ph-neg) acute lymphoblastic leukemia (ALL) with high-risk (HR', 'High-Risk Philadelphia Chromosome-Negative Adult Lymphoblastic Leukemia']","['allo-HSCT', 'chemotherapy or allo-HSCT', 'delayed consolidation and maintenance therapy', 'Chemotherapy or Allogeneic Transplantation', 'chemotherapy and 106 to allo-HSCT', 'allogeneic hematopoietic stem cell transplantation (allo-HSCT']","['5-year (±95%CI) cumulative incidence of relapse (CIR), overall survival (OS) and event-free survival (EFS) probabilities', 'CIR and OS rates', 'CR']","[{'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumour'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0016263', 'cui_str': 'Flow cytometry'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C4517393', 'cui_str': '0.01'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3888511', 'cui_str': 'Philadelphia chromosome negative'}, {'cui': 'C0023448', 'cui_str': 'Lymphoid leukemia'}]","[{'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",218.0,0.0706388,Our results show that avoiding allo-HSCT does not hamper the outcomes of HR Ph-neg adult ALL patients up to 60y with adequate MRD response after induction and consolidation.,"[{'ForeName': 'Josep-Maria', 'Initials': 'JM', 'LastName': 'Ribera', 'Affiliation': ""Institut Català d'Oncologia-Hospital Germans Trias i Pujol, Josep Carreras Research Institute, Badalona, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Morgades', 'Affiliation': ""Institut Català d'Oncologia-Hospital Germans Trias i Pujol, Josep Carreras Research Institute, Badalona, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Juana', 'Initials': 'J', 'LastName': 'Ciudad', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Instituto de Biología Molecular y Celular del Cáncer (IBMCC), Centro de Investigación del Cáncer, Centro de Investigación Biomédica en Red de Cáncer (CIBERONC), Universidad de Salamanca-Centro Superior de Investigaciones Científicas (CSIC), Hospital Universitario, Salamanca, Spain.'}, {'ForeName': 'Pau', 'Initials': 'P', 'LastName': 'Montesinos', 'Affiliation': 'Department of Hematology, Hospital Universitario La Fe, Valencia, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Esteve', 'Affiliation': ""Department of Hematology, Hospital Clínic, Institut D'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Eulàlia', 'Initials': 'E', 'LastName': 'Genescà', 'Affiliation': ""Institut Català d'Oncologia-Hospital Germans Trias i Pujol, Josep Carreras Research Institute, Badalona, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Barba', 'Affiliation': ""Department of Hematology, Hospital Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Ribera', 'Affiliation': ""Institut Català d'Oncologia-Hospital Germans Trias i Pujol, Josep Carreras Research Institute, Badalona, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'García-Cadenas', 'Affiliation': 'Department of Hematology, Hospital de Sant Pau, Barcelona, Spain.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Moreno', 'Affiliation': 'Department of Hematology, Hospital Virgen de la Victoria, Málaga, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Martínez-Carballeira', 'Affiliation': 'Department of Hematology, Hospital Central de Asturias, Oviedo, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Torrent', 'Affiliation': ""Institut Català d'Oncologia-Hospital Germans Trias i Pujol, Josep Carreras Research Institute, Badalona, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Martínez-Sánchez', 'Affiliation': 'Department of Hematology, Hospital Doce de Octubre, Madrid, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Monsalvo', 'Affiliation': 'Department of Hematology, Hospital Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Gil', 'Affiliation': 'Department of Hematology, Hospital General, Alicante, Spain.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Tormo', 'Affiliation': 'Department of Hematology, Hospital Clínico, Instituto de Investigación INCLIVA, Valencia, Spain.'}, {'ForeName': 'María Teresa', 'Initials': 'MT', 'LastName': 'Artola', 'Affiliation': 'Department of Hematology, Hospital Universitario, Donostia, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Cervera', 'Affiliation': ""Institut Català d'Oncologia-Hospital Joan XXIII, Tarragona, Spain.""}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'González-Campos', 'Affiliation': 'Department of Hematology, Hospital Universitario Virgen del Rocío, Sevilla, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Rodríguez', 'Affiliation': 'Department of Hematology, Hospital Doctor Negrín, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Arancha', 'Initials': 'A', 'LastName': 'Bermúdez', 'Affiliation': 'Department of Hematology, Hospital Marqués de Valdecilla, Santander, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Novo', 'Affiliation': 'Department of Hematology, Hospital Son Espases, Palma de Mallorca, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Soria', 'Affiliation': 'Department of Hematology, Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Coll', 'Affiliation': ""Institut Català d'Oncologia-Hospital Josep Trueta, Girona, Spain.""}, {'ForeName': 'María-Luz', 'Initials': 'ML', 'LastName': 'Amigo', 'Affiliation': 'Department of Hematology, Hospital Morales Meseguer, Murcia, Spain.'}, {'ForeName': 'Aurelio', 'Initials': 'A', 'LastName': 'López-Martínez', 'Affiliation': 'Department of Hematology, Hospital Arnau de Vilanova, Valencia, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Fernández-Martín', 'Affiliation': 'Department of Hematology, Hospital Universitario Insular, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Josefina', 'Initials': 'J', 'LastName': 'Serrano', 'Affiliation': 'Department of Hematology, Hospital Reina Sofía, Córdoba, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Mercadal', 'Affiliation': ""Institut Català d'Oncologia-Hospital Duran i Reynals, L'Hospitalet de Llobregat, Spain.""}, {'ForeName': 'Antònia', 'Initials': 'A', 'LastName': 'Cladera', 'Affiliation': 'Department of Hematology, Hospital Son Llàtzer, Palma de Mallorca, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Giménez-Conca', 'Affiliation': 'Department of Hematology, Hospital Italiano, Buenos Aires, Argentina.'}, {'ForeName': 'María-Jesús', 'Initials': 'MJ', 'LastName': 'Peñarrubia', 'Affiliation': 'Department of Hematology, Hospital Clínico, Valladolid, Spain.'}, {'ForeName': 'Eugènia', 'Initials': 'E', 'LastName': 'Abella', 'Affiliation': 'Department of Hematology, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Vall-Llovera', 'Affiliation': 'Department of Hematology, Hospital Universitari Mútua, Terrassa, Spain.'}, {'ForeName': 'Jesús-María', 'Initials': 'JM', 'LastName': 'Hernández-Rivas', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Instituto de Biología Molecular y Celular del Cáncer (IBMCC), Centro de Investigación del Cáncer, Centro de Investigación Biomédica en Red de Cáncer (CIBERONC), Universidad de Salamanca-Centro Superior de Investigaciones Científicas (CSIC), Hospital Universitario, Salamanca, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Garcia-Guiñon', 'Affiliation': 'Department of Hematology, Hospital Arnau de Vilanova, Lleida, Spain.'}, {'ForeName': 'Juan-Miguel', 'Initials': 'JM', 'LastName': 'Bergua', 'Affiliation': 'Department of Hematology, Hospital San Pedro de Alcántara, Cáceres, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'de Rueda', 'Affiliation': 'Department of Hematology, Hospital Miguel Servet, Zaragoza, Spain.'}, {'ForeName': 'María-José', 'Initials': 'MJ', 'LastName': 'Sánchez-Sánchez', 'Affiliation': 'Department of Hematology, Hospital Lucus Augusti, Lugo, Spain.'}, {'ForeName': 'Alfons', 'Initials': 'A', 'LastName': 'Serrano', 'Affiliation': 'Department of Hematology, Hospital HM Sanchinarro, Madrid, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Calbacho', 'Affiliation': 'Department of Hematology, Hospital Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Alonso', 'Affiliation': 'Department of Hematology, Hospital Clínico, Santiago de Compostela, Spain.'}, {'ForeName': 'Jose-Ángel', 'Initials': 'JÁ', 'LastName': 'Méndez-Sánchez', 'Affiliation': 'Department of Hematology, Complejo Hospitalario, Ourense, Spain.'}, {'ForeName': 'Raimundo', 'Initials': 'R', 'LastName': 'García-Boyero', 'Affiliation': 'Department of Hematology, Hospital General, Castellón, Spain.'}, {'ForeName': 'Matxalen', 'Initials': 'M', 'LastName': 'Olivares', 'Affiliation': 'Department of Hematology, Hospital Universitario, Galdakao, Spain; and.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Barrena', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Instituto de Biología Molecular y Celular del Cáncer (IBMCC), Centro de Investigación del Cáncer, Centro de Investigación Biomédica en Red de Cáncer (CIBERONC), Universidad de Salamanca-Centro Superior de Investigaciones Científicas (CSIC), Hospital Universitario, Salamanca, Spain.'}, {'ForeName': 'Lurdes', 'Initials': 'L', 'LastName': 'Zamora', 'Affiliation': ""Institut Català d'Oncologia-Hospital Germans Trias i Pujol, Josep Carreras Research Institute, Badalona, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Granada', 'Affiliation': ""Institut Català d'Oncologia-Hospital Germans Trias i Pujol, Josep Carreras Research Institute, Badalona, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Lhermitte', 'Affiliation': 'Université de Paris, Institut Necker-Enfants Malades, Institut National de Recherche Médicale U1151, Laboratory of Onco-Hematology, Assistance Publique-Hôpitaux de Paris, Hôpital Necker Enfants-Malades, Paris, France.'}, {'ForeName': 'Evarist', 'Initials': 'E', 'LastName': 'Feliu', 'Affiliation': ""Institut Català d'Oncologia-Hospital Germans Trias i Pujol, Josep Carreras Research Institute, Badalona, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Orfao', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Instituto de Biología Molecular y Celular del Cáncer (IBMCC), Centro de Investigación del Cáncer, Centro de Investigación Biomédica en Red de Cáncer (CIBERONC), Universidad de Salamanca-Centro Superior de Investigaciones Científicas (CSIC), Hospital Universitario, Salamanca, Spain.'}]",Blood,['10.1182/blood.2020007311'] 1018,33152169,"Reduction of stent-associated morbidity by minimizing stent material: a prospective, randomized, single-blind superiority trial assessing a customized 'suture stent'.","OBJECTIVES To compare a customized 'suture stent' with a standard ureteric stent regarding stent-related symptoms, safety and efficacy. MATERIALS AND METHODS Patients with urolithiasis located proximal to the iliac vessel crossing, requiring stenting in preparation for secondary ureterorenoscopy (URS) were randomized to standard ureteric stenting or a suture stent. Secondary ureterorenoscopy was performed 2-6 weeks later. The Ureteral Stent Symptoms Questionnaire (USSQ) was completed after 1 week, on the day before URS and 2-6 weeks after stent removal. Stent efficacy and safety were systematically assessed. RESULTS A total of 88 patients were included in the analysis. The median (range) suture stent length was 10 (5-25) cm vs 26 cm for standard stents. Operation time was longer for insertion of the suture stent (24.0 vs 14.5 min; P < 0.001). Patients with a suture stent had a significantly lower USSQ urinary symptoms score 1 week after stent insertion, adjusted for baseline symptoms by subtracting scores from the final visit without indwelling stent (mean 7.1 vs 13.7, difference -6.6, 95% confidence interval [CI] -3.4 to -9.8; P < 0.001). Prior to secondary URS (after 2-6 weeks), baseline-adjusted urinary symptoms (mean 4.7 vs 12.2, difference -7.5, 95% CI -4.5 to -10.4; P < 0.001) and pain subscores (11.5 vs 17.6, difference -6.1, 95% CI -0.7 to -11.6; P = 0.004) were significantly lower in the suture stent group. All other USSQ subscores showed no significant differences. Adverse events occurred in 15 patients and were similarly frequent in the two groups. No significant differences were found between the groups regarding ureteric access during secondary URS. CONCLUSION Replacement of the distal part of ureteric stents by a suture can reduce stent-associated symptoms without restrictions regarding secondary stone removal or safety.",2020,"Operation time was longer for insertion of the Suture-Stent (24.0 vs. 14.5 min, p<0.001).","['Patients with urolithiasis located proximal to the iliac vessel crossing requiring stenting for preparation of secondary URS', 'Totally 88 patients were included to the analysis']","['minimizing stent material', 'standard ureteral stenting or a Suture-Stent', 'customized Suture-Stent with a standard ureteral stent regarding stent', 'customized ""Suture-Stent']","['baseline-adjusted urinary symptoms', 'Adverse events', 'Ureteral Stent Symptoms Questionnaire', 'ureteral access', 'Operation time', 'pain subscores', 'Median Suture-Stent length', 'USSQ-urinary symptoms score', 'Stent efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0451641', 'cui_str': 'Urolithiasis'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0729890', 'cui_str': 'Iliac vessel'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1522613', 'cui_str': 'Ureteral route'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0183518', 'cui_str': 'Ureteric stent'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0183518', 'cui_str': 'Ureteric stent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1522613', 'cui_str': 'Ureteral route'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0449462', 'cui_str': 'Length of stent'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",88.0,0.188238,"Operation time was longer for insertion of the Suture-Stent (24.0 vs. 14.5 min, p<0.001).","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Betschart', 'Affiliation': 'Department of Urology, Cantonal Hospital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Piller', 'Affiliation': 'Department of Urology, Cantonal Hospital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Zumstein', 'Affiliation': 'Department of Urology, Cantonal Hospital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Schmid', 'Affiliation': 'Department of Urology, Cantonal Hospital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Engeler', 'Affiliation': 'Department of Urology, Cantonal Hospital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Güsewell', 'Affiliation': 'Biostatistics, Clinical Trials Unit, Cantonal Hospital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Manolis', 'Initials': 'M', 'LastName': 'Pratsinis', 'Affiliation': 'Department of Urology, Cantonal Hospital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Abt', 'Affiliation': 'Department of Urology, Cantonal Hospital St. Gallen, St. Gallen, Switzerland.'}]",BJU international,['10.1111/bju.15290'] 1019,33152672,"Health economic design for cost, cost-effectiveness and simulation analyses in the HEALing Communities Study.","BACKGROUND The HEALing Communities Study (HCS) is designed to implement and evaluate the Communities That HEAL (CTH) intervention, a conceptually driven framework to assist communities in selecting and adopting evidence-based practices to reduce opioid overdose deaths. The goal of the HCS is to produce generalizable information for policy makers and community stakeholders seeking to implement CTH or a similar community intervention. To support this objective, one aim of the HCS is a health economics study (HES), the results of which will inform decisions around fiscal feasibility and sustainability relevant to other community settings. METHODS The HES is integrated into the HCS design: an unblinded, multisite, parallel arm, cluster randomized, wait list-controlled trial of the CTH intervention implemented in 67 communities in four U.S. states: Kentucky, Massachusetts, New York, and Ohio. The objectives of the HES are to estimate the economic costs to communities of implementing and sustaining CTH; estimate broader societal costs associated with CTH; estimate the cost-effectiveness of CTH for overdose deaths avoided; and use simulation modeling to evaluate the short- and long-term health and economic impact of CTH, including future overdose deaths avoided and quality-adjusted life years saved, and to develop a simulation policy tool for communities that seek to implement CTH or a similar community intervention. DISCUSSION The HCS offers an unprecedented opportunity to conduct health economics research on solutions to the opioid crisis and to increase understanding of the impact and value of complex, community-level interventions.",2020,"The HES is integrated into the HCS design: an unblinded, multisite, parallel arm, cluster randomized, wait list-controlled trial of the CTH intervention implemented in 67 communities in four U.S. states: Kentucky, Massachusetts, New York, and Ohio.","['67 communities in four U.S. states: Kentucky, Massachusetts, New York, and Ohio']","['CTH intervention', 'HCS', 'HEAL (CTH) intervention', 'CTH']",[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0022557', 'cui_str': 'Kentucky'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],,0.0271047,"The HES is integrated into the HCS design: an unblinded, multisite, parallel arm, cluster randomized, wait list-controlled trial of the CTH intervention implemented in 67 communities in four U.S. states: Kentucky, Massachusetts, New York, and Ohio.","[{'ForeName': 'Arnie P', 'Initials': 'AP', 'LastName': 'Aldridge', 'Affiliation': 'RTI International, 3040 East Cornwallis Road, RTP, NC, 27709, United States. Electronic address: aaldridge@rti.org.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Barbosa', 'Affiliation': 'RTI International, 3040 East Cornwallis Road, RTP, NC, 27709, United States.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Barocas', 'Affiliation': 'Boston Medical Center, One Boston Medical Center Pl, Boston, MA, 02118, United States; University of Pennsylvania School of Nursing, 418 Curie Blvd, Philadelphia, PA, 19104, United States.'}, {'ForeName': 'Joshua L', 'Initials': 'JL', 'LastName': 'Bush', 'Affiliation': 'University of Kentucky, College of Public Health, 111 Washington Ave., Lexington, KY, 40536, United States.'}, {'ForeName': 'Jagpreet', 'Initials': 'J', 'LastName': 'Chhatwal', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, 55 Fruit St, Boston, MA, 02114, United States.'}, {'ForeName': 'Kristin J', 'Initials': 'KJ', 'LastName': 'Harlow', 'Affiliation': 'The Ohio State University College of Public Health, 250 Cunz Hall, 1841 Neil Ave., Columbus, OH, 43210, United States.'}, {'ForeName': 'Ayaz', 'Initials': 'A', 'LastName': 'Hyder', 'Affiliation': 'The Ohio State University College of Public Health, 250 Cunz Hall, 1841 Neil Ave., Columbus, OH, 43210, United States.'}, {'ForeName': 'Benjamin P', 'Initials': 'BP', 'LastName': 'Linas', 'Affiliation': 'Boston Medical Center, One Boston Medical Center Pl, Boston, MA, 02118, United States.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'McCollister', 'Affiliation': 'University of Miami Miller School of Medicine, 1120 NW 14(th)Street, Suite 1019, Miami, FL, 33136, United States.'}, {'ForeName': 'Jake R', 'Initials': 'JR', 'LastName': 'Morgan', 'Affiliation': 'Boston University School of Public Health, 715 Albany St, Boston, MA, 02118, United States.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Murphy', 'Affiliation': 'Weill Cornell Medicine, 425 East 61(st)Street, Suite 301, New York, NY, 10065, United States.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Savitzky', 'Affiliation': 'Boston Medical Center, One Boston Medical Center Pl, Boston, MA, 02118, United States.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Schackman', 'Affiliation': 'Weill Cornell Medicine, 425 East 61(st)Street, Suite 301, New York, NY, 10065, United States.'}, {'ForeName': 'Eric E', 'Initials': 'EE', 'LastName': 'Seiber', 'Affiliation': 'The Ohio State University College of Public Health, 250 Cunz Hall, 1841 Neil Ave., Columbus, OH, 43210, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'E Starbird', 'Affiliation': 'Columbia University, New York, NY, 10027, United States; University of Pennsylvania School of Nursing, 418 Curie Blvd, Philadelphia, PA, 19104, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Villani', 'Affiliation': 'National Institute on Drug Abuse, 3WFN RM08A45, MSC 6025, 301 North Stonestreet Ave, Rockville, MD, 20852, United States.'}, {'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Zarkin', 'Affiliation': 'RTI International, 3040 East Cornwallis Road, RTP, NC, 27709, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108336'] 1020,33155057,Green Light Exposure Improves Pain and Quality of Life in Fibromyalgia Patients: A Preliminary One-Way Crossover Clinical Trial.,"OBJECTIVE Fibromyalgia is a functional pain disorder in which patients suffer from widespread pain and poor quality of life. Fibromyalgia pain and its impact on quality of life are not effectively managed with current therapeutics. Previously, in a preclinical rat study, we demonstrated that exposure to green light-emitting diodes (GLED) for 8 hours/day for 5 days resulted in antinociception and reversal of thermal and mechanical hypersensitivity associated with models of injury-related pain. Given the safety of GLED and the ease of its use, our objective is to administer GLED as a potential therapy to patients with fibromyalgia. DESIGN One-way crossover clinical trial. SETTING United States. METHOD We enrolled 21 adult patients with fibromyalgia recruited from the University of Arizona chronic pain clinic who were initially exposed to white light-emitting diodes and then were crossed over to GLED for 1 to 2 hours daily for 10 weeks. Data were collected by using paper surveys. RESULTS When patients were exposed to GLED, but not white light-emitting diodes, they reported a significant reduction in average pain intensity on the 10-point numeric pain scale. Secondary outcomes were assessed by using the EQ-5D-5L survey, Short-Form McGill Pain Questionnaire, and Fibromyalgia Impact Questionnaire and were also significantly improved in patients exposed to GLED. GLED therapy was not associated with any measured side effects in these patients. CONCLUSION Although the mechanism by which GLED elicits pain reduction is currently being studied, these results supporting its efficacy and safety merit a larger clinical trial.",2021,"Secondary outcomes were assessed by using the EQ-5D-5L survey, Short-Form McGill Pain Questionnaire, and Fibromyalgia Impact Questionnaire and were also significantly improved in patients exposed to GLED.","['United States', '21 adult patients with fibromyalgia recruited from the University of Arizona chronic pain clinic who were initially exposed to white light-emitting diodes and then were crossed over to', 'Fibromyalgia Patients', 'patients with fibromyalgia']","['GLED', 'Green Light Exposure', 'GLED therapy']","['EQ-5D-5L survey, Short-Form McGill Pain Questionnaire, and Fibromyalgia Impact Questionnaire', 'side effects', '10-point numeric pain scale', 'Fibromyalgia pain', 'quality of life', 'average pain intensity', 'antinociception and reversal of thermal and mechanical hypersensitivity', 'Pain and Quality of Life']","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0003787', 'cui_str': 'Arizona - US state'}, {'cui': 'C3839654', 'cui_str': 'Chronic pain clinic'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}]","[{'cui': 'C1306567', 'cui_str': 'Green light'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0457972', 'cui_str': 'Short form McGill pain questionnaire'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",21.0,0.0995394,"Secondary outcomes were assessed by using the EQ-5D-5L survey, Short-Form McGill Pain Questionnaire, and Fibromyalgia Impact Questionnaire and were also significantly improved in patients exposed to GLED.","[{'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Martin', 'Affiliation': 'Departments of Pharmacology, University of Arizona, Tucson, Arizona, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Porreca', 'Affiliation': 'Departments of Pharmacology, University of Arizona, Tucson, Arizona, USA.'}, {'ForeName': 'Elizabeth I', 'Initials': 'EI', 'LastName': 'Mata', 'Affiliation': 'College of Medicine, University of Arizona, Tucson, Arizona, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Salloum', 'Affiliation': 'College of Medicine, University of Arizona, Tucson, Arizona, USA.'}, {'ForeName': 'Vasudha', 'Initials': 'V', 'LastName': 'Goel', 'Affiliation': 'Department of Anesthesiology, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Gunnala', 'Affiliation': 'Departments of Pharmacology, University of Arizona, Tucson, Arizona, USA.'}, {'ForeName': 'Wiliam D S', 'Initials': 'WDS', 'LastName': 'Killgore', 'Affiliation': 'Psychiatry, University of Arizona, Tucson, Arizona, USA.'}, {'ForeName': 'Sejal', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Neurology, University of Arizona, Tucson, Arizona, USA.'}, {'ForeName': 'Felesia N', 'Initials': 'FN', 'LastName': 'Jones-MacFarland', 'Affiliation': 'Neurology, University of Arizona, Tucson, Arizona, USA.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Khanna', 'Affiliation': 'Departments of Pharmacology, University of Arizona, Tucson, Arizona, USA.'}, {'ForeName': 'Amol', 'Initials': 'A', 'LastName': 'Patwardhan', 'Affiliation': 'Departments of Pharmacology, University of Arizona, Tucson, Arizona, USA.'}, {'ForeName': 'Mohab M', 'Initials': 'MM', 'LastName': 'Ibrahim', 'Affiliation': 'Departments of Pharmacology, University of Arizona, Tucson, Arizona, USA.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa329'] 1021,33159658,"Pharmacokinetics, Safety and Tolerability of Once-Weekly Subcutaneous Semaglutide in Healthy Chinese Subjects: A Double-Blind, Phase 1, Randomized Controlled Trial.","INTRODUCTION Once-weekly (OW) subcutaneous (s.c.) semaglutide is an injectable glucagon-like peptide-1 (GLP-1) analogue approved for the treatment of type 2 diabetes. This trial was designed to assess the pharmacokinetics, safety and tolerability of OW s.c. semaglutide in healthy Chinese subjects. METHODS In this single-centre, randomised, double-blind, placebo-controlled trial, 36 healthy subjects were randomised to OW s.c. semaglutide 0.5 mg (n = 12), 1.0 mg (n = 12), or placebo (n = 12). Treatment (semaglutide or placebo) was blinded for the subjects, investigators and sponsor. The primary endpoint was steady-state semaglutide exposure, defined as the area under the curve over a dosing interval at steady state (AUC 0-168 h,SS ). RESULTS In total, 34 subjects completed the trial. The steady-state exposure of semaglutide was higher for subjects treated with 1.0 mg semaglutide (AUC 0-168 h,ss : 7961 nmol h/l and C max,ss : 55.9 nmol/l) compared to 0.5 mg semaglutide (AUC 0-168 h,ss : 4000 nmol h/l and C max,ss : 28.8 nmol/l). The total exposure of semaglutide increased in a dose-proportional manner in healthy Chinese subjects; the treatment ratio (1.0 mg/0.5 mg) [95% confidence interval] for AUC 0-168 h,SS was 1.99 [1.78; 2.23]. Treatment with OW s.c. semaglutide was well tolerated in healthy Chinese subjects. As expected for the GLP-1 receptor agonist class, the most common adverse events were gastrointestinal, and no new safety signals were identified. CONCLUSION The pharmacokinetics, safety and tolerability of OW s.c. semaglutide in healthy Chinese subjects were consistent with previous clinical pharmacology trials of OW s.c. semaglutide in other populations. The results suggest that no dose adjustment is necessary for semaglutide in Chinese patients with T2D. TRIAL REGISTRATION ClinicalTrials.gov, identifier NCT03288740.",2021,The total exposure of semaglutide increased in a dose-proportional manner in healthy Chinese subjects; the treatment ratio (1.0 mg/0.5 mg),"['Healthy Chinese Subjects', '34 subjects completed the trial', 'healthy Chinese subjects', '36 healthy subjects']","['Treatment (semaglutide or placebo', 'placebo', 'Once-Weekly Subcutaneous Semaglutide', 'semaglutide 0.5']","['steady-state semaglutide exposure, defined as the area under the curve over a dosing interval at steady state (AUC 0-168\xa0h,SS ', 'Pharmacokinetics, Safety and Tolerability', 'total exposure of semaglutide', 'steady-state exposure of semaglutide', 'pharmacokinetics, safety and tolerability of OW', 'pharmacokinetics, safety and tolerability']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}]",36.0,0.221703,The total exposure of semaglutide increased in a dose-proportional manner in healthy Chinese subjects; the treatment ratio (1.0 mg/0.5 mg),"[{'ForeName': 'Aixin', 'Initials': 'A', 'LastName': 'Shi', 'Affiliation': ""Clinical Trial Center, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People's Republic of China. aixins0302@126.com.""}, {'ForeName': 'Panpan', 'Initials': 'P', 'LastName': 'Xie', 'Affiliation': ""Clinical Trial Center, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.""}, {'ForeName': 'Lasse Lykke', 'Initials': 'LL', 'LastName': 'Nielsen', 'Affiliation': 'Novo Nordisk A/S, Bagsværd, Denmark.'}, {'ForeName': 'Trine Vang', 'Initials': 'TV', 'LastName': 'Skjøth', 'Affiliation': 'Novo Nordisk A/S, Bagsværd, Denmark.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'He', 'Affiliation': ""Clinical Trial Center, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.""}, {'ForeName': 'Sine Pfeiffer', 'Initials': 'SP', 'LastName': 'Haugaard', 'Affiliation': 'Novo Nordisk A/S, Bagsværd, Denmark.'}]",Advances in therapy,['10.1007/s12325-020-01548-y'] 1022,33202147,PAP Adherence and Nasal Resistance. A Randomized Controlled Trial of CPAPflex versus CPAP in World Trade Center Responders.,"Rationale: Continuous positive airway pressure (CPAP) adherence is often poor in obstructive sleep apnea (OSA) and may be influenced by nasal resistance. CPAP with a reduction of expiratory pressure (CPAPflex) may reduce discomfort in those with high nasal resistance and improve adherence in this subgroup. Objectives: To evaluate the association of positive airway pressure (PAP) treatment adherence to nasal resistance and examine if CPAPflex improves adherence over CPAP in subjects with high nasal resistance. Methods: A randomized double-blind crossover trial of 4 weeks each of CPAPflex versus CPAP in subjects exposed to World Trade Center dust with OSA stratified by nasal resistance, measured by 4-Phase Rhinomanometry. Results: Three hundred seventeen subjects with OSA (mean, apnea-hypopnea index with 4% O 2 desaturation for hypopnea = 17 ± 14/h) were randomized. Overall, PAP adherence was poor, but adherence to CPAP ( n  = 239; mean hours per night [95% confidence interval (CI)]), 1.97 h (1.68 to 2.26) was greater than adherence to CPAPflex ( n  = 249; 1.65 h [1.39 to 1.91]; difference of 0.31 h [0.03; 0.6]; P  < 0.05). Contrary to our hypothesis there was no correlation between nasal resistance and adherence to CPAP ( r  = 0.098; P  = not significant) or CPAPflex ( r  = 0.056; P  = not significant). There was no difference in adherence between CPAP and CPAPflex (mean Δ hours [95% CI]) in subjects with low resistance (0.33 h [-0.10 to 0.76]) or high nasal resistance (0.26 h [-0.14 to 0.66]). No significant differences were observed in any of the secondary outcomes between PAP modes. Conclusions: Contrary to expectations, our data do not show better adherence to CPAPflex than to CPAP in subjects with high or low nasal resistance and do show clinically insignificant better adherence overall with CPAP.Clinical trial registered with www.clinicaltrials.gov (NCT01753999).",2021,"There was no difference in adherence between CPAP and CPAP Flex (mean Δ hours (95% CI)) in subjects with low resistance (0.33h (-0.10, 0.76)) or high nasal resistance (0.26h (-0.14, 0.66)).","['in World Trade Center dust-exposed subjects with OSA stratified by nasal resistance measured by 4-Phase Rhinomanometry', 'subjects with high nasal resistance', '317 subjects with OSA (mean AHI4%=17±14/hr', 'obstructive sleep apnea (OSA']","['CPAP Flex', 'CPAP with reduction of expiratory pressure (CPAP Flex ', 'CPAP Flex versus CPAP', 'CPAP Flex vs CPAP']","['nasal resistance and adherence to CPAP', 'adherence to CPAP', 'PAP Adherence and Nasal Resistance', 'adherence between CPAP and CPAP Flex', 'Overall, PAP adherence', 'high nasal resistance']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0013330', 'cui_str': 'Dust'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0429208', 'cui_str': 'Nasal resistance'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0430615', 'cui_str': 'Rhinomanometry'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]","[{'cui': 'C0429208', 'cui_str': 'Nasal resistance'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205250', 'cui_str': 'High'}]",317.0,0.14355,"There was no difference in adherence between CPAP and CPAP Flex (mean Δ hours (95% CI)) in subjects with low resistance (0.33h (-0.10, 0.76)) or high nasal resistance (0.26h (-0.14, 0.66)).","[{'ForeName': 'Jag', 'Initials': 'J', 'LastName': 'Sunderram', 'Affiliation': 'Department of Medicine, Robert Wood Johnson Medical School, Rutgers University, New Brunswick, New Jersey.'}, {'ForeName': 'Indu', 'Initials': 'I', 'LastName': 'Ayappa', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, and.'}, {'ForeName': 'Shou-En', 'Initials': 'SE', 'LastName': 'Lu', 'Affiliation': 'Division of Occupational Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Division of Occupational Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Black', 'Affiliation': 'School of Public Health and.'}, {'ForeName': 'Akosua', 'Initials': 'A', 'LastName': 'Twumasi', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, and.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Sanders', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, and.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Harrison', 'Affiliation': 'Environmental and Occupational Health Sciences Institute, Rutgers Biomedical and Health Sciences, Rutgers University, Piscataway, New Jersey; and.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Udasin', 'Affiliation': 'School of Public Health and.'}, {'ForeName': 'Nishay', 'Initials': 'N', 'LastName': 'Chitkara', 'Affiliation': 'Environmental and Occupational Health Sciences Institute, Rutgers Biomedical and Health Sciences, Rutgers University, Piscataway, New Jersey; and.'}, {'ForeName': 'Rafael E', 'Initials': 'RE', 'LastName': 'de la Hoz', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, School of Medicine, New York University, New York, New York.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Carson', 'Affiliation': 'Department of Medicine, Robert Wood Johnson Medical School, Rutgers University, New Brunswick, New Jersey.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Rapoport', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, and.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.202009-1161OC'] 1023,33158079,Prospective Evaluation of Mango Fruit Intake on Facial Wrinkles and Erythema in Postmenopausal Women: A Randomized Clinical Pilot Study.,"Mangos are rich in β-carotene and other carotenoids, along with several phenolic acids that may provide oxidant defense and photoprotection to the skin. The objectives of this study are to investigate the effects of Ataulfo mango intake on the development of facial wrinkles and erythema. A randomized two-group parallel-arm study was conducted to assess 16 weeks of either 85 g or 250 g of mango intake in healthy postmenopausal women with Fitzpatrick skin type II or III. Facial photographs were captured at weeks 0, 8, and 16, and wrinkles at the lateral canthi and erythema at the cheeks were quantified. Skin carotenoid values were measured with reflection spectroscopy. Deep wrinkle severity decreased significantly in the 85 g group after 8 ( p = 0.007) and 16 ( p = 0.03) weeks compared to baseline measures. In contrast, those in the 250 g group showed an increase after 16 weeks in average wrinkle severity ( p = 0.049), average wrinkle length ( p = 0.007), fine wrinkle severity ( p = 0.02), and emerging wrinkle severity ( p = 0.02). Erythema in the cheeks increased with 85 g of mango intake ( p = 0.04). The intake of 85 g of mangos reduced wrinkles in fair-skinned postmenopausal women, while an intake of 250 g showed the opposite effect. Further studies feeding 85 g of mangos are warranted.",2020,Deep wrinkle severity decreased significantly in the 85 g group after 8 ( p = 0.007) and 16 ( p = 0.03) weeks compared to baseline measures.,"['Postmenopausal Women', 'healthy postmenopausal women with Fitzpatrick skin type II or III']","['Mango Fruit Intake', 'Ataulfo mango intake']","['facial wrinkles and erythema', 'Deep wrinkle severity', 'Erythema', 'fine wrinkle severity', 'Facial Wrinkles and Erythema', 'average wrinkle length', 'Skin carotenoid values', 'emerging wrinkle severity', 'average wrinkle severity']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0440284', 'cui_str': 'Mango fruit'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0330955', 'cui_str': 'Mangifera indica'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0007271', 'cui_str': 'Carotinoid'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0487652,Deep wrinkle severity decreased significantly in the 85 g group after 8 ( p = 0.007) and 16 ( p = 0.03) weeks compared to baseline measures.,"[{'ForeName': 'Vivien W', 'Initials': 'VW', 'LastName': 'Fam', 'Affiliation': 'Department of Nutrition, UC Davis, Davis, CA 95616, USA.'}, {'ForeName': 'Roberta R', 'Initials': 'RR', 'LastName': 'Holt', 'Affiliation': 'Department of Nutrition, UC Davis, Davis, CA 95616, USA.'}, {'ForeName': 'Carl L', 'Initials': 'CL', 'LastName': 'Keen', 'Affiliation': 'Department of Nutrition, UC Davis, Davis, CA 95616, USA.'}, {'ForeName': 'Raja K', 'Initials': 'RK', 'LastName': 'Sivamani', 'Affiliation': 'Department of Dermatology, UC Davis, Sacramento, CA 95816, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Hackman', 'Affiliation': 'Department of Nutrition, UC Davis, Davis, CA 95616, USA.'}]",Nutrients,['10.3390/nu12113381'] 1024,33158101,Effects of the Preschool-Based Family-Involving DAGIS Intervention on Family Environment: A Cluster Randomised Trial.,"Interventions promoting young children's healthy energy balance-related behaviours (EBRBs) should also examine changes in the family environment as this is an important determinant that may affect the effectiveness of the intervention. This study examines family environmental effects of the Increased Health and Wellbeing in Preschools (DAGIS) intervention study, and whether these effects differed when considering three parental educational level (PEL) groups. The DAGIS intervention was conducted in preschools and involving parents in Southern Finland from September 2017 to May 2018. It was designed as a randomised trial, clustered at preschool-level. Parents of 3-6-year-olds answered questionnaires recording PEL, parental role modelling for EBRBs, and the family environment measured as EBRBs availability and accessibility. Linear Mixed Models with Repeated Measures were used in order to detect intervention effects. Models included group by time interactions. When examining intervention effects separated by PEL groups, models with three-level interactions (group × time-points × PEL) were evaluated. There was an interaction effect for the availability of sugary everyday foods and drinks ( p = 0.002). The analyses showed that the control group increased availability ( p = 0.003), whereas in the intervention group no changes were detected ( p = 0.150). In the analysis separated by PEL groups, changes were found only for the accessibility of sugary treats at home; the high PEL control group increased the accessibility of sugary treats ( p = 0.022) (interaction effect: p = 0.027). Hence, results suggest that the DAGIS multicomponent intervention had a limited impact on determinants for children's healthy EBRBs, and no impact was found in the low PEL group.",2020,There was an interaction effect for the availability of sugary everyday foods and drinks ( p = 0.002).,"['preschools and involving parents in Southern Finland from September 2017 to May 2018', ""young children's healthy energy balance-related behaviours (EBRBs"", 'Family Environment']",['Preschool-Based Family-Involving DAGIS Intervention'],"['availability', 'EBRBs availability and accessibility', 'accessibility of sugary treats']","[{'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]",,0.0423531,There was an interaction effect for the availability of sugary everyday foods and drinks ( p = 0.002).,"[{'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Ray', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}, {'ForeName': 'Rejane', 'Initials': 'R', 'LastName': 'Figueiredo', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}, {'ForeName': 'Riikka', 'Initials': 'R', 'LastName': 'Pajulahti', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}, {'ForeName': 'Henna', 'Initials': 'H', 'LastName': 'Vepsäläinen', 'Affiliation': 'Department of Food and Nutrition, University of Helsinki, P.O. Box 66, FI-00014 Helsinki, Finland.'}, {'ForeName': 'Elviira', 'Initials': 'E', 'LastName': 'Lehto', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}, {'ForeName': 'Reetta', 'Initials': 'R', 'LastName': 'Lehto', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}, {'ForeName': 'Maijaliisa', 'Initials': 'M', 'LastName': 'Erkkola', 'Affiliation': 'Department of Food and Nutrition, University of Helsinki, P.O. Box 66, FI-00014 Helsinki, Finland.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Roos', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}]",Nutrients,['10.3390/nu12113387'] 1025,33164611,Upadacitinib monotherapy versus methotrexate monotherapy in methotrexate-naïve Japanese patients with rheumatoid arthritis: a sub-analysis of the Phase 3 SELECT-EARLY study.,"OBJECTIVE To assess upadacitinib monotherapy versus methotrexate (MTX) in MTX-naïve Japanese patients with rheumatoid arthritis (RA) from the Phase 3 SELECT-EARLY study. METHODS Japanese patients were randomized 2:1:1:1 to upadacitinib 7.5, 15, or 30 mg daily or MTX 7.5 mg/week (titrated to ≤15 mg/week). Efficacy endpoints included the proportion of patients reporting 20% improvement in American College of Rheumatology criteria (ACR20) at week 12 and change from baseline in modified Total Sharp Score (mTSS) at week 24. Other efficacy outcomes were also assessed at weeks 12 and/or 24. Safety was assessed over 24 weeks. RESULTS Of 138 Japanese patients enrolled, significantly more patients treated with upadacitinib 7.5 and 15 mg, but not 30 mg, reported ACR20 responses versus MTX at week 12. Significantly smaller changes from baseline in mTSS were observed with upadacitinib 15 and 30 mg, but not 7.5 mg, versus MTX at week 24. Upadacitinib demonstrated an acceptable safety profile; herpes zoster occurred in 3.6%, 7.4%, and 7.1% of patients treated with upadacitinib 7.5, 15, and 30 mg, respectively. CONCLUSION Similar to the global study population, upadacitinib demonstrated clinical efficacy superior to placebo in the Japanese subpopulation. Among upadacitinib-treated patients, herpes zoster was least common with 7.5 mg.",2021,"Upadacitinib demonstrated an acceptable safety profile; herpes zoster occurred in 3.6%, 7.4%, and 7.1% of patients treated with upadacitinib 7.5, 15, and 30 mg, respectively. ","['MTX-naïve Japanese patients with rheumatoid arthritis (RA', '138 Japanese patients', 'naïve Japanese patients with rheumatoid arthritis', 'Japanese patients']","['upadacitinib monotherapy versus methotrexate (MTX', 'methotrexate monotherapy', 'methotrexate', 'MTX', 'Upadacitinib monotherapy', 'placebo']","['Safety', 'acceptable safety profile; herpes zoster', 'herpes zoster', 'proportion of patients reporting 20% improvement in American College of Rheumatology criteria (ACR20']","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C4726929', 'cui_str': 'upadacitinib'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0019360', 'cui_str': 'Herpes zoster'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]",138.0,0.0482558,"Upadacitinib demonstrated an acceptable safety profile; herpes zoster occurred in 3.6%, 7.4%, and 7.1% of patients treated with upadacitinib 7.5, 15, and 30 mg, respectively. ","[{'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Rischmueller', 'Affiliation': 'The Queen Elizabeth Hospital and University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Blanco', 'Affiliation': 'Hospital Universitario Marques de Valdecilla, Cantabria, Spain.'}, {'ForeName': 'Ricardo M', 'Initials': 'RM', 'LastName': 'Xavier', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Yukitaka', 'Initials': 'Y', 'LastName': 'Ueki', 'Affiliation': 'Rheumatic and Collagen Disease Center, Sasebo Chuo Hospital, Sasebo, Nagasaki, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Atsumi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'AbbVie Inc., North Chicago, IL, United States.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Friedman', 'Affiliation': 'AbbVie Inc., North Chicago, IL, United States.'}, {'ForeName': 'Aileen L', 'Initials': 'AL', 'LastName': 'Pangan', 'Affiliation': 'AbbVie Inc., North Chicago, IL, United States.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Strand', 'Affiliation': 'Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, United States.'}, {'ForeName': 'Ronald F', 'Initials': 'RF', 'LastName': 'van Vollenhoven', 'Affiliation': 'Amsterdam University Medical Centers, Amsterdam, The Netherlands.'}]",Modern rheumatology,['10.1080/14397595.2020.1847776'] 1026,33165151,A Pilot Trial Examining the Merits of Combining Amantadine and Repetitive Transcranial Magnetic Stimulation as an Intervention for Persons With Disordered Consciousness After TBI.,"OBJECTIVE Report pilot findings of neurobehavioral gains and network changes observed in persons with disordered consciousness (DoC) who received repetitive transcranial magnetic stimulation (rTMS) or amantadine (AMA), and then rTMS+AMA. PARTICIPANTS Four persons with DoC 1 to 15 years after traumatic brain injury (TBI). DESIGN Alternate treatment-order, within-subject, baseline-controlled trial. MAIN MEASURES For group and individual neurobehavioral analyses, predetermined thresholds, based on mixed linear-effects models and conditional minimally detectable change, were used to define meaningful neurobehavioral change for the Disorders of Consciousness Scale-25 (DOCS) total and Auditory-Language measures. Resting-state functional connectivity (rsFC) of the default mode and 6 other networks was examined. RESULTS Meaningful gains in DOCS total measures were observed for 75% of treatment segments and auditory-language gains were observed after rTMS, which doubled when rTMS preceded rTMS+AMA. Neurobehavioral changes were reflected in rsFC for language, salience, and sensorimotor networks. Between networks interactions were modulated, globally, after all treatments. CONCLUSIONS For persons with DoC 1 to 15 years after TBI, meaningful neurobehavioral gains were observed after provision of rTMS, AMA, and rTMS+AMA. Sequencing and combining of treatments to modulate broad-scale neural activity, via differing mechanisms, merits investigation in a future study powered to determine efficacy of this approach to enabling neurobehavioral recovery.",2020,"RESULTS Meaningful gains in DOCS total measures were observed for 75% of treatment segments and auditory-language gains were observed after rTMS, which doubled when rTMS preceded rTMS+AMA.","['persons with disordered consciousness (DoC', 'Persons With Disordered Consciousness', 'Four persons with DoC 1 to 15 years after traumatic brain injury (TBI']","['Amantadine and Repetitive Transcranial Magnetic Stimulation', 'repetitive transcranial magnetic stimulation (rTMS) or amantadine (AMA']","['auditory-language gains', 'DOCS total measures', 'meaningful neurobehavioral change for the Disorders of Consciousness Scale-25 (DOCS) total and Auditory-Language measures', 'rsFC for language, salience, and sensorimotor networks', 'Resting-state functional connectivity (rsFC', 'meaningful neurobehavioral gains', 'Neurobehavioral changes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009791', 'cui_str': 'Consciousness related finding'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}]","[{'cui': 'C0002403', 'cui_str': 'Amantadine'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0009792', 'cui_str': 'Consciousness Disorders'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]",4.0,0.0175242,"RESULTS Meaningful gains in DOCS total measures were observed for 75% of treatment segments and auditory-language gains were observed after rTMS, which doubled when rTMS preceded rTMS+AMA.","[{'ForeName': 'Theresa L', 'Initials': 'TL', 'LastName': 'Bender Pape', 'Affiliation': 'The Department of Veterans Affairs (VA), Center for Innovation in Complex Chronic Healthcare & Research Service, Edward Hines Jr VA Hospital, Hines, Illinois (Drs Bender Pape, Herrold, Livengood, Guernon, Walsh, Kletzel, and Pacheco); Departments of Physical Medicine and Rehabilitation (Drs Bender Pape and Livengood), Neurological Surgery (Dr Rosenow), Radiology (Mr Higgins and Dr Parrish), and Psychiatry and Behavioral Sciences (Dr Herrold), Northwestern University Feinberg School of Medicine, Chicago, Illinois; Research Department, Marianjoy Rehabilitation Hospital-part of Northwestern Medicine, Wheaton, Illinois (Dr Guernon); Department of Psychiatry, Biostatistical Research Center, Division of Epidemiology and Biostatistics, University of Illinois at Chicago, Chicago (Drs R. Bhaumik and D. K. Bhaumik); Cooperative Studies Program Coordinating Center, Research Service, Edward Hines Jr VA Hospital, Hines, Illinois (Dr D. K. Bhaumik); Department of Clinical Research and Leadership, School of Medicine and Health Sciences, The George Washington University, Washington (Ms Weaver and Dr Mallinson); Department of Neurology, Edward Hines Jr VA Hospital, Hines, Illinois, and Department of Neurology, Loyola University Chicago Stritch School of Medicine, Maywood, Illinois (Dr Patil); Chicago Medical School, Rosalind Franklin University of Science and Medicine, and Department of Radiology and Nuclear Medicine, Captain James A Lovell Federal Health Care Center, North Chicago, Illinois (Dr Conneely).'}, {'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Herrold', 'Affiliation': ''}, {'ForeName': 'Sherri L', 'Initials': 'SL', 'LastName': 'Livengood', 'Affiliation': ''}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Guernon', 'Affiliation': ''}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Weaver', 'Affiliation': ''}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Higgins', 'Affiliation': ''}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Rosenow', 'Affiliation': ''}, {'ForeName': 'Elyse', 'Initials': 'E', 'LastName': 'Walsh', 'Affiliation': ''}, {'ForeName': 'Runa', 'Initials': 'R', 'LastName': 'Bhaumik', 'Affiliation': ''}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Pacheco', 'Affiliation': ''}, {'ForeName': 'Vijaya K', 'Initials': 'VK', 'LastName': 'Patil', 'Affiliation': ''}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Kletzel', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Conneely', 'Affiliation': ''}, {'ForeName': 'Dulal K', 'Initials': 'DK', 'LastName': 'Bhaumik', 'Affiliation': ''}, {'ForeName': 'Trudy', 'Initials': 'T', 'LastName': 'Mallinson', 'Affiliation': ''}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Parrish', 'Affiliation': ''}]",The Journal of head trauma rehabilitation,['10.1097/HTR.0000000000000634'] 1027,33160931,Is there a role of toothpastes in the development of recurrent aphthous stomatitis? A prospective controlled clinical trial with skin patch testing.,"OBJECTIVES The oral mucosa is exposed to a large number of antigenic agents contained in toothpastes. These agents are reported to stimulate recurrent aphthous stomatitis (RAS) pathogenesis, and toothpastes that do not contain probable allergenic substances reduced the number and frequency of aphthous ulcers. We aimed to determine whether the skin patch test (SPT) can be used to determine if toothpaste allergens play a role in the etiology of RAS. STUDY DESIGN Sixty-three patients with RAS and 47 healthy volunteers were skin patch tested with sodium lauryl sulfate, cocamidopropyl betaine, propylene glycol, aluminum chloride hexahydrate, menthol, triclosan, and titanium dioxide, which are present in most of the toothpastes. Fisher's exact test and the Yates chi-square test were used to compare categorical variables and patch test results between 2 groups. RESULTS The SPT was positive in 8 (22.2%) patients with RAS and 11 (23.4%) control subjects, and the difference between the groups was not statistically significant (P < .05). Sodium lauryl sulfate, titanium dioxide, and menthol were the most common positive allergens in both groups. CONCLUSIONS Allergens in toothpastes did not appear to stimulate the formation of RAS. However, in order to determine a clearer relationship, a study in a larger patient series employing intraoral patch testing with more toothpaste ingredients is suggested.",2021,"The SPT was positive in 8 (22.2%) patients with RAS and 11 (23.4%) control subjects, and the difference between the groups was not statistically significant (P < .05).",['Sixty-three patients with RAS and 47 healthy volunteers were skin patch tested with'],"['Sodium lauryl sulfate, titanium dioxide, and menthol', 'skin patch test (SPT', 'sodium lauryl sulfate, cocamidopropyl betaine, propylene glycol, aluminum chloride hexahydrate, menthol, triclosan, and titanium dioxide']",['formation of RAS'],"[{'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2931748', 'cui_str': 'Sutton disease 2'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030646', 'cui_str': 'Patch test'}]","[{'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0076733', 'cui_str': 'titanium dioxide'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0030646', 'cui_str': 'Patch test'}, {'cui': 'C0173050', 'cui_str': 'cocamidopropyl betaine'}, {'cui': 'C0033437', 'cui_str': 'Propanediols'}, {'cui': 'C0051512', 'cui_str': 'Aluminum chloride hexahydrate'}, {'cui': 'C0040958', 'cui_str': 'Triclosan'}]","[{'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C2931748', 'cui_str': 'Sutton disease 2'}]",63.0,0.044114,"The SPT was positive in 8 (22.2%) patients with RAS and 11 (23.4%) control subjects, and the difference between the groups was not statistically significant (P < .05).","[{'ForeName': 'Hatice', 'Initials': 'H', 'LastName': 'Kaya Ozden', 'Affiliation': 'Department of Dermatology, Kocaeli Derince Training and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Ayse Adin', 'Initials': 'AA', 'LastName': 'Selcuk', 'Affiliation': 'Department of Otorhinolaryngology, Bahcesehir University Medical Faculty, Goztepe, Istanbul, Turkey. Electronic address: adinselcuk@gmail.com.'}]","Oral surgery, oral medicine, oral pathology and oral radiology",['10.1016/j.oooo.2020.10.006'] 1028,33169863,Comparison of two vitamin D supplementation strategies in children with sickle cell disease: a randomized controlled trial.,"Previously, we showed that nearly 70% of children followed in our sickle cell disease (SCD) clinic were vitamin D- deficient and had low vitamin intake with poor use of supplements. We compared the change in serum 25-hydroxyvitamin D [25(OH)D], safety and clinical impact of two vitamin D supplementation regimens in children with SCD. Children (5-17 years, all genotypes) were randomized to a single bolus of vitamin D 3 (300 000 IU; n = 18) or placebo (n = 20). All children received a prescription for daily 1 000 IU vitamin D 3 . Serum 25(OH)D and calcium, urinary calcium/creatinine ratio, musculoskeletal pain, quality of life, haematology and bone markers were assessed at baseline and three months post intervention. Bolus administration led to a greater rise in 25(OH)D levels from baseline compared to placebo (20 ± 16 nmol/l vs. 2 ± 19 nmol/l; P = 0·003) and correction of vitamin D deficiency. No hypercalcaemia nor hypercalciuria occurred during the study, but more children in the bolus group experienced gastrointestinal symptoms within the first month (P = 0·04). There were no differences between groups for other outcomes. The use of a high-dose vitamin D bolus combined with daily 1 000 IU vitamin D 3 was more efficient in raising 25(OH)D levels than daily supplementation alone in children with SCD.",2021,Bolus administration led to a greater rise in 25(OH)D levels from baseline compared to placebo (20 ± 16 nmol/l vs. 2 ± 19 nmol/l; P = 0·003) and correction of vitamin D deficiency.,"['children with sickle cell disease', 'children with SCD', 'Children (5-17\xa0years, all genotypes']","['placebo', 'vitamin D supplementation regimens', 'vitamin D supplementation strategies', 'vitamin D']","['gastrointestinal symptoms', 'Serum 25(OH)D and calcium, urinary calcium/creatinine ratio, musculoskeletal pain, quality of life, haematology and bone markers', '25(OH)D levels', 'serum 25-hydroxyvitamin D [25(OH)D], safety and clinical impact', 'hypercalcaemia nor hypercalciuria']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0428613', 'cui_str': 'Calcium/creatinine ratio measurement'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274119', 'cui_str': 'Hematopathology'}, {'cui': 'C0181734', 'cui_str': 'Bone marker'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0020437', 'cui_str': 'Hypercalcemia'}, {'cui': 'C0020438', 'cui_str': 'Hypercalciuria'}]",,0.473195,Bolus administration led to a greater rise in 25(OH)D levels from baseline compared to placebo (20 ± 16 nmol/l vs. 2 ± 19 nmol/l; P = 0·003) and correction of vitamin D deficiency.,"[{'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Grégoire-Pelchat', 'Affiliation': 'Department of Nutrition, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Pastore', 'Affiliation': 'Research Center, Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Robitaille', 'Affiliation': 'Research Center, Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'LeMay', 'Affiliation': 'Research Center, Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Khamessan', 'Affiliation': 'Euro-Pharm International Canada Inc, Montreal, Quebec, Canada.'}, {'ForeName': 'Niina', 'Initials': 'N', 'LastName': 'Kleiber', 'Affiliation': 'Research Center, Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Nyalendo', 'Affiliation': 'Department of Clinical Biochemistry, Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Gagné', 'Affiliation': 'Department of Pediatrics, Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Alos', 'Affiliation': 'Research Center, Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada.'}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': 'Mailhot', 'Affiliation': 'Department of Nutrition, Université de Montréal, Montreal, Quebec, Canada.'}]",British journal of haematology,['10.1111/bjh.17119'] 1029,33172597,III. Detecting Treatment Effects in Clinical Trials With Different Indices of Pain Intensity Derived From Ecological Momentary Assessment.,"Pain intensity represents the primary outcome in most pain clinical trials. Identifying methods to measure aspects of pain that are most sensitive to treatment may facilitate discovery of effective interventions. In this third of 3 articles examining alternative indices of pain intensity derived from ecological momentary assessments (EMA), we compare treatment effects based on Average Pain, Maximum Pain, Minimum Pain, Pain Variability, Time in High Pain, Time in Low Pain, and Pain After Wake-Up. We also examine which indices contribute to Patient Global Impressions of Change (PGIC). Data came from 2 randomized, double-blind, placebo-controlled trials examining the efficacy of milnacipran for fibromyalgia treatment; 2,084 patients provided >1 million EMA pain intensity ratings over 24 (Study 1) or 26 (Study 2) treatment weeks. Pain Variability and Time in High Pain produced significantly smaller treatment effects than Average Pain; other pain indices showed effects that were numerically smaller, but not significantly different from Average Pain. Changes in all pain indices were significantly associated with PGIC, with improvements in Maximum Pain and in Pain Variability offering small incremental contributions to understanding PGIC over Average Pain. Results suggest that different pain indices could be used to detect treatment effects in pain clinical trials. PERSPECTIVE: Alternative summary measures of pain intensity derived from EMA may broaden the scope of outcomes useful in pain clinical trials. In this analysis of a pharmacological treatment for fibromyalgia, most pain summary measures indicated similar effects; improvements in Maximum Pain and Pain Variability contributed to understanding PGIC over Average Pain.",2021,"Changes in all pain indices were significantly associated with PGIC, with improvements in Maximum Pain and in Pain Variability offering small incremental contributions to understanding PGIC over Average Pain.","['fibromyalgia treatment; 2,084 patients provided >1 million EMA pain intensity ratings over 24 (Study 1) or 26 (Study 2) treatment weeks']","['milnacipran', 'placebo']","['Maximum Pain and in Pain Variability', 'pain indices', 'Pain Intensity', 'Patient Global Impressions of Change (PGIC', 'pain intensity', 'Pain intensity', 'Average Pain, Maximum Pain, Minimum Pain, Pain Variability, Time in High Pain, Time in Low Pain, and Pain', 'Maximum Pain and Pain Variability', 'Pain Variability and Time in High Pain']","[{'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C1533126', 'cui_str': 'milnacipran'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",2084.0,0.209846,"Changes in all pain indices were significantly associated with PGIC, with improvements in Maximum Pain and in Pain Variability offering small incremental contributions to understanding PGIC over Average Pain.","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schneider', 'Affiliation': 'Dornsife Center for Self-Report Science, University of Southern California, California. Electronic address: schneids@usc.edu.'}, {'ForeName': 'Doerte U', 'Initials': 'DU', 'LastName': 'Junghaenel', 'Affiliation': 'Dornsife Center for Self-Report Science, University of Southern California, California.'}, {'ForeName': 'Masakatsu', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': 'Dornsife Center for Self-Report Science, University of Southern California, California.'}, {'ForeName': 'Joan E', 'Initials': 'JE', 'LastName': 'Broderick', 'Affiliation': 'Dornsife Center for Self-Report Science, University of Southern California, California.'}, {'ForeName': 'Arthur A', 'Initials': 'AA', 'LastName': 'Stone', 'Affiliation': 'Dornsife Center for Self-Report Science, University of Southern California, California; Deparment of Psychology, University of Southern California, California.'}]",The journal of pain,['10.1016/j.jpain.2020.10.003'] 1030,33174080,Benefit-Risk or Risk-Benefit Trade-Offs? Another Look at Attribute Ordering Effects in a Pilot Choice Experiment.,"BACKGROUND Studies recommend randomising the order of attributes in discrete choice experiments (DCEs) to avoid bias; however, in a benefit-risk setting, this may increase the cognitive burden of respondents who compare the benefits and risks of treatments, or may affect their decision-making process. Based on these concerns, this paper explored attribute ordering effects in a benefit-risk DCE. METHOD Attribute ordering effects were explored in a large pilot DCE relating to the medical treatment of insomnia. Participants were randomised to one of three presentation orders: (1) benefits were presented before risks (BR); (2) risks were presented before benefits (RB); (3) all attributes were randomised (RN). For the RB and BR presentation orders, attributes were randomised within benefits and risks. Responses were assessed in three ways. First, variations in respondents' self-reported choice certainty were obtained. Second, variations in failure rates of stability and dominance tests were calculated. Third, a heteroscedastic error component model tested for differences in choice consistency across the three attribute orderings. RESULTS The final analysis included 156 respondents (RN: 54; BR: 49; RB: 53). No differences were found between the presentation orders with respect to stated choice certainty, or the proportion of respondents failing either the dominance or stability test. However, deterministic attribute grouping was associated with higher choice consistency. CONCLUSION To increase choice consistency, DCE attributes should be randomised within logical groups that may be further randomised to reduce the risk of ordering effects.",2021,"No differences were found between the presentation orders with respect to stated choice certainty, or the proportion of respondents failing either the dominance or stability test.",[],[],['failure rates of stability and dominance tests'],[],[],"[{'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1287621', 'cui_str': 'Eye dominance - finding'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",156.0,0.0632265,"No differences were found between the presentation orders with respect to stated choice certainty, or the proportion of respondents failing either the dominance or stability test.","[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Heidenreich', 'Affiliation': 'Evidera Inc., London, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Phillips-Beyer', 'Affiliation': 'Innovus Consulting, London, UK. innovusconsultingltd@gmail.com.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Flamion', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Ross', 'Affiliation': 'Evidera Inc., London, UK.'}, {'ForeName': 'Jaein', 'Initials': 'J', 'LastName': 'Seo', 'Affiliation': 'Evidera Inc., London, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Marsh', 'Affiliation': 'Evidera Inc., London, UK.'}]",The patient,['10.1007/s40271-020-00475-y'] 1031,33175291,Tiotropium/Olodaterol Delays Clinically Important Deterioration Compared with Tiotropium Monotherapy in Patients with Early COPD: a Post Hoc Analysis of the TONADO ® Trials.,"INTRODUCTION Since chronic obstructive pulmonary disease (COPD) is a heterogeneous condition, a composite endpoint of clinically important deterioration (CID) may provide a more holistic assessment of treatment efficacy. We compared long-acting muscarinic antagonist/long-acting β 2 -agonist combination therapy with tiotropium/olodaterol versus tiotropium alone using a composite endpoint for CID. CID was evaluated overall and in patients with low exacerbation history (at most one moderate exacerbation in the past year [not leading to hospitalisation]), Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2 patients and maintenance-naïve patients with COPD. We assessed whether early treatment optimisation is more effective with tiotropium/olodaterol versus tiotropium in delaying and reducing the risk of CID. METHODS Data were analysed from 2055 patients treated with either tiotropium/olodaterol 5/5 μg or tiotropium 5 μg (delivered via Respimat ® ) in two replicate, 52-week, parallel-group, double-blind studies (TONADO ®  1/2). CID was defined as a decline of at least 0.1 L from baseline in trough forced expiratory volume in 1 s, increase from baseline of at least 4 units in St. George's Respiratory Questionnaire score, or moderate/severe exacerbation. Time to first occurrence of one of these events was recorded as time to first CID. RESULTS Overall, treatment with tiotropium/olodaterol significantly increased the time to, and reduced the risk of, CID versus tiotropium (median time to CID 226 versus 169 days; hazard ratio [HR] 0.76 [95% confidence interval 0.68, 0.85]; P < 0.0001). Significant reductions were also observed in patients with low exacerbation history (241 versus 170; HR 0.73 [0.64, 0.83]; P < 0.0001), GOLD 2 patients (241 versus 169; 0.72 [0.61, 0.84]; P < 0.0001) and maintenance-naïve patients (233 versus 171; 0.75 [0.62, 0.91]; P = 0.0030). CONCLUSION In patients with COPD, including patients with low exacerbation history, GOLD 2 patients and maintenance-naïve patients, tiotropium/olodaterol reduced the risk of CID versus tiotropium. These results demonstrate the advantages of treatment optimisation with tiotropium/olodaterol over tiotropium monotherapy. TRIAL REGISTRATION ClinicalTrials.gov identifier: TONADO ® 1 and 2 (NCT01431274 and NCT01431287, registered 8 September 2011).",2021,"Significant reductions were also observed in patients with low exacerbation history (241 versus 170; HR 0.73 [0.64, 0.83]; P < 0.0001), GOLD 2 patients (241 versus 169; 0.72 [0.61, 0.84]; P < 0.0001) and maintenance-naïve patients (233 versus 171; 0.75 [0.62, 0.91]; P = 0.0030). ","['Data were analysed from 2055 patients treated with either', 'Patients with Early COPD']","['Tiotropium Monotherapy', 'tiotropium/olodaterol', 'tiotropium/olodaterol 5/5\xa0μg or tiotropium 5\xa0μg (delivered via Respimat ® ', 'tiotropium', 'tiotropium/olodaterol versus tiotropium', 'Tiotropium/Olodaterol']","['risk of, CID', 'CID', 'Respiratory Questionnaire score, or moderate/severe exacerbation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C2934193', 'cui_str': 'olodaterol'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",2.0,0.379732,"Significant reductions were also observed in patients with low exacerbation history (241 versus 170; HR 0.73 [0.64, 0.83]; P < 0.0001), GOLD 2 patients (241 versus 169; 0.72 [0.61, 0.84]; P < 0.0001) and maintenance-naïve patients (233 versus 171; 0.75 [0.62, 0.91]; P = 0.0030). ","[{'ForeName': 'Klaus F', 'Initials': 'KF', 'LastName': 'Rabe', 'Affiliation': 'LungenClinic Grosshansdorf, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany. k.f.rabe@lungenclinic.de.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Chalmers', 'Affiliation': 'Tayside Respiratory Research Group, University of Dundee, Dundee, UK.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Miravitlles', 'Affiliation': ""Pneumology Department, Hospital Universitari Vall d'Hebron, Vall d'Hebron Research Institute (VHIR), Barcelona, Spain.""}, {'ForeName': 'Janwillem W H', 'Initials': 'JWH', 'LastName': 'Kocks', 'Affiliation': 'General Practitioners Research Institute, Groningen, The Netherlands.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Tsiligianni', 'Affiliation': 'Health Planning Unit, Department of Social Medicine, Faculty of Medicine, University of Crete, Crete, Greece.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'de la Hoz', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Wenqiong', 'Initials': 'W', 'LastName': 'Xue', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Medicines Evaluation Unit (MEU), University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Gary T', 'Initials': 'GT', 'LastName': 'Ferguson', 'Affiliation': 'Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA.'}, {'ForeName': 'Jadwiga', 'Initials': 'J', 'LastName': 'Wedzicha', 'Affiliation': 'Respiratory Division, National Heart and Lung Institute, Imperial College London, London, UK.'}]",Advances in therapy,['10.1007/s12325-020-01528-2'] 1032,33176593,A randomised controlled trial of neuromuscular stimulation in non-operative venous disease improves clinical and symptomatic status.,"BACKGROUND This randomised controlled trial investigates the dosing effect of neuromuscular electrical stimulation (NMES) in patients with chronic venous disease (CVD). METHODS Seventy-six patients with CEAP C3-C5 were randomised to Group A (no NMES), B (30 minutes of NMES daily) or C (60 minutes of NMES daily). Primary outcome was percentage change in Femoral Vein Time Averaged Mean Velocity (TAMV) at 6 weeks. Clinical severity scores, disease-specific and generic quality of life (QoL) were assessed. RESULTS Seventy-six patients were recruited - mean age 60.8 (SD14.4) and 47:29 male. Six patients lost to follow-up. Percentage change in TAMV (p<0.001) was significantly increased in Groups B and C. Aberdeen Varicose Veins Questionnaire Score (-6.9, p=0.029) and Venous Clinical Severity Score (-4, p-0.003) improved in Group C, and worsened in Group A (+1, p=0.025). CONCLUSIONS Daily NMES usage increases flow parameters, with twice daily usage improving QoL and clinical severity at 6 weeks in CVD patients.",2021,"Percentage change in TAMV (p<0.001) was significantly increased in Groups B and C. Aberdeen Varicose Veins Questionnaire Score (-6.9, p=0.029) and Venous Clinical Severity Score (-4, p-0.003) improved in Group C, and worsened in Group A (+1, p=0.025). ","['Seventy-six patients with CEAP C3-C5', 'Seventy-six patients were recruited - mean age 60.8 (SD14.4) and 47:29 male', 'patients with chronic venous disease (CVD']","['neuromuscular electrical stimulation (NMES', 'neuromuscular stimulation']","['Aberdeen Varicose Veins Questionnaire Score', 'Clinical severity scores, disease-specific and generic quality of life (QoL', 'percentage change in Femoral Vein Time Averaged Mean Velocity (TAMV', 'Percentage change in TAMV', 'QoL and clinical severity', 'Venous Clinical Severity Score']","[{'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0235522', 'cui_str': 'Disorder of vein'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0454448', 'cui_str': 'Neuromuscular stimulation'}]","[{'cui': 'C0042345', 'cui_str': 'Phlebectasia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015809', 'cui_str': 'Femoral vein structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}]",76.0,0.297965,"Percentage change in TAMV (p<0.001) was significantly increased in Groups B and C. Aberdeen Varicose Veins Questionnaire Score (-6.9, p=0.029) and Venous Clinical Severity Score (-4, p-0.003) improved in Group C, and worsened in Group A (+1, p=0.025). ","[{'ForeName': 'Raveena', 'Initials': 'R', 'LastName': 'Ravikumar', 'Affiliation': 'Section of Vascular Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'Tristan Ra', 'Initials': 'TR', 'LastName': 'Lane', 'Affiliation': 'Section of Vascular Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'Adarsh', 'Initials': 'A', 'LastName': 'Babber', 'Affiliation': 'Section of Vascular Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Onida', 'Affiliation': 'Section of Vascular Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'Alun H', 'Initials': 'AH', 'LastName': 'Davies', 'Affiliation': 'Section of Vascular Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.'}]",Phlebology,['10.1177/0268355520968640'] 1033,33179263,Treatment Outcomes in Patients Treated With Galcanezumab vs Placebo: Post Hoc Analyses From a Phase 3 Randomized Study in Patients With Episodic Cluster Headache.,"BACKGROUND Cluster headache (CH) is a highly disabling primary headache disorder. To date, characterization of outcomes in the preventive treatment of episodic CH, including precise definitions of clinically meaningful attack frequency reduction and impact on acute treatment management, is lacking. METHODS This was a Phase 3, randomized, double-blind, placebo-controlled study in patients (men or women aged 18-65 years) diagnosed with episodic CH as defined by the International Classification of Headache Disorders-3 beta criteria. In this post hoc analysis, we evaluated the median time-to-first occurrence of ≥50, ≥75, or 100% reduction from baseline in CH attack frequency, and impact on acute medication use. An anchor-based assessment of clinically relevant attack frequency reduction using the Patient Global Impression of Improvement (PGI-I) scores at Week 4 was also assessed. RESULTS The median time-to-first occurrence of ≥50, ≥75, or 100% reduction from baseline in CH attacks was consistently shorter (9-10 days sooner) with galcanezumab vs placebo (median [95% confidence interval, 95% CI]: ≥50%, 5 days [4.0 to 7.0] vs 14 days [6.0 to 19.0]; ≥75%, 11 days [7.0 to 16.0] vs 21 days [13.0 to 26.0]; 100%, 22 days [16.0 to 37.0] vs 32 days [23.0 to 34.0]). Mean reduction from baseline in the overall frequency of weekly pooled acute medication use across Weeks 1-3 was significantly greater with galcanezumab vs placebo (11.0 vs 5.5; odds ratio, OR [95% CI]: 5.52 [1.02, 10.01]; P value = .017). Patients reporting ""much better"" on the PGI-I experienced a median weekly CH attack reduction of approximately 43% from baseline across Weeks 1-3. The overall odds of achieving an attack reduction threshold of 43% across Weeks 1-3 was significantly higher with galcanezumab vs placebo (Weeks 1-3: OR [95% CI], 2.60 [1.3 to 5.3]). CONCLUSIONS Faster median time-to-first occurrence of response rates, lower frequency of pooled acute medications use, and a greater proportion of patients achieving a response anchored by patient-reported improvement were observed for galcanezumab vs placebo.",2020,"The overall odds of achieving an attack reduction threshold of 43% across Weeks 1-3 was significantly higher with galcanezumab vs placebo (Weeks 1-3: OR [95% CI], 2.60 [1.3 to 5.3]). ","['Patients With Episodic Cluster Headache', 'patients (men or women aged 18-65\xa0years) diagnosed with episodic CH as defined by the International Classification of Headache Disorders-3 beta criteria']","['placebo', 'galcanezumab vs placebo', 'Galcanezumab vs Placebo']","['median time-to-first occurrence', 'CH attacks', 'overall odds of achieving an attack reduction', 'median weekly CH attack reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0393739', 'cui_str': 'Episodic cluster headache'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0393735', 'cui_str': 'Headache disorder'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4694273', 'cui_str': 'galcanezumab'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0009088', 'cui_str': 'Cluster headache'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]",,0.635537,"The overall odds of achieving an attack reduction threshold of 43% across Weeks 1-3 was significantly higher with galcanezumab vs placebo (Weeks 1-3: OR [95% CI], 2.60 [1.3 to 5.3]). ","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kudrow', 'Affiliation': 'California Medical Clinic for Headache, Santa Monica, CA, USA.'}, {'ForeName': 'J Scott', 'Initials': 'JS', 'LastName': 'Andrews', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Mallikarjuna', 'Initials': 'M', 'LastName': 'Rettiganti', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Oakes', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Bardos', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Charly', 'Initials': 'C', 'LastName': 'Gaul', 'Affiliation': 'Migraine and Headache Clinic, Koenigstein, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Riesenberg', 'Affiliation': 'Atlanta Center for Medical Research, Atlanta, GA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Wenzel', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Dulanji', 'Initials': 'D', 'LastName': 'Kuruppu', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Martinez', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}]",Headache,['10.1111/head.14011'] 1034,33180670,Efficacy of the AS04-adjuvanted HPV-16/18 vaccine in young Chinese women with oncogenic HPV infection at baseline: post-hoc analysis of a randomized controlled trial.,"Human papillomavirus (HPV) vaccines are efficacious against HPV infections and associated lesions in women HPV-naïve at vaccination. However, vaccine efficacy (VE) against oncogenic, high-risk HPV (HR-HPV) types in women infected with any other HR-HPV type at first vaccination (baseline) remains unclear. This post-hoc analysis of a phase II/III study (NCT00779766) evaluated AS04-adjuvanted HPV-16/18 (AS04-HPV-16/18) VE against HR-HPV type infection in 871 Chinese women aged 18-25 years over a 72-month follow-up period. Study participants were DNA-negative at baseline to HR-HPV type(s) considered for VE and DNA-positive to any other HR-HPV type. Initial serostatus was not considered. Baseline DNA prevalence was 14.6% for any HR-HPV type and 10.6% excluding HPV-16/18. In the total vaccinated cohort for efficacy, VE against 6-month and 12-month HPV-16/18 persistent infections (PIs) in women DNA-negative to HPV-16/18 but DNA-positive to any other HR-HPV type at baseline was 100.0% (95% Confidence Interval [CI]: 79.8-100.0) and 100.0% (95%CI: 47.2-100.0), respectively. VE against HPV-16/18 incident infections in women DNA-positive to one vaccine type but DNA-negative to the other one at baseline was 66.8% (95%CI: -18.9-92.5). VE against HPV-31/33/45 incident infections, in women DNA-positive to HPV-16/18 and DNA-negative to the considered HPV type at baseline was 71.0% (95%CI: 27.3-89.8). No HPV-16/18 PIs were observed in vaccinated women with non-vaccine HPV A7/A9 species cervical infection at baseline. These findings indicated that women with existing HR-HPV infection at vaccination might still benefit from the AS04-HPV-16/18 vaccine. However, this potential benefit needs further demonstration in the future.",2021,No HPV-16/18 PIs were observed in vaccinated women with non-vaccine HPV A7/A9 species cervical infection at baseline.,"['women DNA-positive to HPV-16/18 and DNA', 'young Chinese women with oncogenic HPV infection at baseline', '871 Chinese women aged 18-25\xa0years over a 72-month follow-up period']","['Human papillomavirus (HPV) vaccines', 'AS04-adjuvanted HPV-16/18 (AS04-HPV-16/18) VE against HR-HPV type infection', 'AS04-adjuvanted HPV-16/18 vaccine']","['Baseline DNA prevalence', 'vaccine efficacy (VE) against oncogenic, high-risk HPV (HR-HPV) types']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0343641', 'cui_str': 'Human papilloma virus infection'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",871.0,0.329418,No HPV-16/18 PIs were observed in vaccinated women with non-vaccine HPV A7/A9 species cervical infection at baseline.,"[{'ForeName': 'Shangying', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Department of Cancer Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiaoqian', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Cancer Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Fengcai', 'Initials': 'F', 'LastName': 'Zhu', 'Affiliation': 'Jiangsu Province Center for Disease Prevention and Control, Nanjing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Hong', 'Affiliation': 'Department of Gynaecology and Obstetrics, Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'Yuemei', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Jiangsu Province Center for Disease Prevention and Control, Nanjing, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Cancer Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Qinjing', 'Initials': 'Q', 'LastName': 'Pan', 'Affiliation': 'Department of Cancer Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Cancer Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Chengfu', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Lianshui Center for Disease Prevention and Control, Lianshui, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Jintan Center for Disease Prevention and Control, Jintan, China.'}, {'ForeName': 'Jiaxi', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Xuzhou Center for Disease Prevention and Control, Xuzhou, China.'}, {'ForeName': 'Jiahong', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Lianshui Center for Disease Prevention and Control, Lianshui, China.'}, {'ForeName': 'Yejiang', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Binhai Center for Disease Prevention and Control, Yancheng, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'Department of Cancer Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': 'Department of Cancer Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Karkada', 'Affiliation': 'GSK, Clinical Research & Development, Wavre, Belgium.'}, {'ForeName': 'Haiwen', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': 'Medical Department, GSK, Shanghai, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Bi', 'Affiliation': 'GSK, Clinical Research & Development, Wavre, Belgium.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Struyf', 'Affiliation': 'GSK, Wavre, Belgium at the Time This Analysis Was Performed. Current Affiliation: Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Fanghui', 'Initials': 'F', 'LastName': 'Zhao', 'Affiliation': 'Department of Cancer Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2020.1829411'] 1035,33183991,Orthodontists' and patients' perceptions regarding techniques to reduce the orthodontic treatment duration.,"BACKGROUND The purpose of this study was to evaluate patients' and orthodontists' perspectives on knowledge of techniques for reducing orthodontic treatment time and acceptance of these techniques. METHODS A total of 200 individuals were interviewed and equally divided into two groups: orthodontist group (62 female and 38 male; mean age, 38.07 years) and patient group (52 female and 48 male; mean age, 22.61 years; in the active stage of fixed orthodontic treatment). One questionnaire for each group was administered, including questions about the duration of orthodontic treatment and techniques used for treatment optimization, such as corticotomy, distraction osteogenesis, vibration, and laser therapy. The associations between variables were analyzed by the χ 2 test at a significance level of 5%. RESULTS Among orthodontists, 76% knew at least one technique to reduce the treatment duration, with corticotomy being the most frequently cited (66%); however, only 12% used one or more of these techniques. Laser therapy was the most frequently implemented technique (7%). Regarding the duration of orthodontic treatment, the mean time reported by orthodontists was 19 to 24 months, regardless of the technique or the experience of the orthodontist. Furthermore, 39% of patients expected their treatment to last for more than 24 months, with 50% accepting to undergo further procedures to reduce this duration. CONCLUSIONS Patients are willing to undergo additional procedures to reduce the treatment duration and to bear additional costs. However, despite their knowledge, orthodontists do not apply or offer these techniques to the patients.",2020,"A total of 200 individuals were interviewed and equally divided into two groups: orthodontist group (62 female and 38 male; mean age, 38.07 years) and patient group (52 female and 48 male; mean age, 22.61 years; in the active stage of fixed orthodontic treatment).","['A total of 200 individuals were interviewed and equally divided into two groups: orthodontist group (62 female and 38 male; mean age, 38.07\xa0years) and patient group (52 female and 48 male; mean age, 22.61\xa0years; in the active stage of fixed orthodontic treatment']",['Laser therapy'],[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0260083', 'cui_str': 'Orthodontist'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}]","[{'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}]",[],200.0,0.015387,"A total of 200 individuals were interviewed and equally divided into two groups: orthodontist group (62 female and 38 male; mean age, 38.07 years) and patient group (52 female and 48 male; mean age, 22.61 years; in the active stage of fixed orthodontic treatment).","[{'ForeName': 'Ana Cláudia de Castro Ferreira', 'Initials': 'ACCF', 'LastName': 'Conti', 'Affiliation': 'Full Professor, Orthodontic Department, University of North Paraná (UNOPAR), Londrina, PR, Brazil. Electronic address: accfconti@uol.com.br.'}, {'ForeName': 'Carolina Fernandes', 'Initials': 'CF', 'LastName': 'Mota Rodrigues', 'Affiliation': 'Former Undergraduate Student, Unisagrado, Bauru, SP, Brazil.'}, {'ForeName': 'Graziela Hernandes', 'Initials': 'GH', 'LastName': 'Volpato', 'Affiliation': 'PhD Student, UNOPAR University of North Paraná, Londrina, PR, Brazil.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'de Miranda Ladewig', 'Affiliation': 'Post-Doctoral Student, UNOPAR University of North Paraná, Londrina, PR, Brazil.'}, {'ForeName': 'Marcio Rodrigues de', 'Initials': 'MR', 'LastName': 'Almeida', 'Affiliation': 'Full Professor, Orthodontic Department, University of North Paraná (UNOPAR), Londrina, PR, Brazil.'}, {'ForeName': 'Renata Rodrigues de', 'Initials': 'RR', 'LastName': 'Almeida-Pedrin', 'Affiliation': 'Full Professor, Orthodontic Department, University of North Paraná (UNOPAR), Londrina, PR, Brazil.'}]",Journal of the World federation of orthodontists,['10.1016/j.ejwf.2020.10.002'] 1036,33184023,Effectiveness of a serious game on the self-concept of children with visual impairments: A randomized controlled trial.,"BACKGROUND Young children with visual impairments (VIs) are at high risk for mental disorders, due to victimization and subsequent social withdrawal. Children with VIs have been shown to have a poorer self-concept and lower general psychosocial well-being compared with peers without VIs. OBJECTIVE The objective of this study was to examine the effectiveness of a serious game to improve psychosocial outcomes in children with VIs. METHODS A randomized controlled trial was conducted to evaluate the effectiveness of the computer game See for children with VIs. The game was developed based on rational-emotive behavioral therapy principles, with the aim of addressing self-concept (academic, social, and general), psychosocial well-being (social inclusion, exclusion, and emotions), and coping strategies (approach, avoidance). Sixty-four children aged 6-8 years were randomized to the intervention group, who played the game, or a control group, who received care-as-usual (CAU). RESULTS Our results showed that children with VIs who played the serious game scored significantly higher on academic self-concept and social inclusion compared with the control group. Furthermore, children rated the game positively, suggesting the desirability, validity, and feasibility of the intervention. CONCLUSIONS The results provide preliminary evidence that a serious game can enhance psychosocial outcomes in children with VIs. This approach might also promote positive educational outcomes, such as academic achievement, and reduce the stigma of therapy for children with VIs. Implications and future directions are discussed.",2021,Our results showed that children with VIs who played the serious game scored significantly higher on academic self-concept and social inclusion compared with the control group.,"['Children with VIs', 'children with visual impairments', 'children with VIs', 'Young children with visual impairments (VIs', 'Sixty-four children aged 6-8 years']","['serious game', 'computer game See', 'control group, who received care-as-usual (CAU']","['psychosocial outcomes', 'academic self-concept and social inclusion']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042798', 'cui_str': 'Dim vision'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0870328', 'cui_str': 'Computer Games'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036594', 'cui_str': 'Self Concept'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]",64.0,0.045334,Our results showed that children with VIs who played the serious game scored significantly higher on academic self-concept and social inclusion compared with the control group.,"[{'ForeName': 'Pieternel', 'Initials': 'P', 'LastName': 'Lievense', 'Affiliation': 'Bartiméus, Doorn, the Netherlands. Electronic address: pilievense@bartimeus.nl.'}, {'ForeName': 'Victorita Stefania', 'Initials': 'VS', 'LastName': 'Vacaru', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Radboud University Nijmegen, the Netherlands. Electronic address: V.Vacaru@donders.ru.nl.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Kruithof', 'Affiliation': 'Bartiméus, Doorn, the Netherlands. Electronic address: ykruithof@bartimeus.nl.'}, {'ForeName': 'Natasja', 'Initials': 'N', 'LastName': 'Bronzewijker', 'Affiliation': 'Bartiméus, Doorn, the Netherlands. Electronic address: nbronzewijker@bartimeus.nl.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Doeve', 'Affiliation': 'Bartiméus, Doorn, the Netherlands. Electronic address: mdoeve@bartimeus.nl.'}, {'ForeName': 'Paula Sophia', 'Initials': 'PS', 'LastName': 'Sterkenburg', 'Affiliation': 'Bartiméus, Doorn, the Netherlands; Department of Clinical Child and Family Studies, Vrije Universiteit Amsterdam, The Netherlands & Amsterdam Public Health Research Institute (APH), Amsterdam, the Netherlands. Electronic address: p.s.sterkenburg@vu.nl.'}]",Disability and health journal,['10.1016/j.dhjo.2020.101017'] 1037,33165938,Eptinezumab Demonstrated Efficacy in Sustained Prevention of Episodic and Chronic Migraine Beginning on Day 1 After Dosing.,"OBJECTIVE To determine the onset of preventive efficacy with eptinezumab in patients with migraine. BACKGROUND Eptinezumab is a monoclonal antibody inhibiting calcitonin gene-related peptide approved as an intravenously administered treatment for the prevention of migraine. METHODS Patients who received eptinezumab 100 mg, eptinezumab 300 mg, or placebo in PROMISE7-1 (episodic migraine; 100 mg, n = 221; 300 mg, n = 222; placebo, n = 222) or PROMISE7-2 (chronic migraine; 100 mg, n = 356; 300 mg, n = 350; placebo, n = 366) were included. Testing of the percentage of patients with a migraine on day 1 after dosing was prespecified and alpha-controlled. In further exploration of this prespecified endpoint, a post hoc closed testing procedure, which controlled the false-positive (type 1) error rate, provided a statistically rigorous evaluation of migraine prevention onset. The procedure involved up to 84 tests of significance, all of which were performed in sequence until the first nonsignificant result. RESULTS For both studies, all tests for significance for eptinezumab 100 and 300 mg, from days 1-84 through day 1 alone, achieved nominal significance (P < .05), indicating that eptinezumab was fully effective beginning on day 1. Over each interval, the treatment effect was comparable to the effect over weeks 1-12. Mean changes from baseline in monthly migraine days for the primary endpoint period ranged from -3.9 to -4.9, -4.1 to -4.9, and -2.2 to -3.2 for eptinezumab 100, 300 mg, and placebo, respectively, in PROMISE7-1 and from -7.2 to -8.0, -7.9 to -8.2, and -4.3 to -5.6, respectively, in PROMISE7-2. The difference from placebo (95% confidence interval) in day 1 treatment effect was -2.2 (-4.1, -0.3) and -2.5 (-4.4, -0.6) days/month for eptinezumab 100 and 300 mg, respectively, in PROMISE7-1, and was -3.8 (-5.6, -2.0) and -4.0 (-5.8, -2.1) days/month for 100 and 300 mg, respectively, in PROMISE7-2. CONCLUSIONS The migraine preventive effect of eptinezumab is rapid and sustained in patients with episodic or chronic migraine, with onset of optimal preventive efficacy observed on the day following the initial dose.",2020,"The difference from placebo (95% confidence interval) in day 1 treatment effect was -2.2 (-4.1, -0.3) and -2.5 (-4.4, -0.6) days/month for eptinezumab 100 and 300 mg, respectively, in PROMISE-1, and was -3.8 (-5.6, -2.0) and -4.0 (-5.8, -2.1) days/month for 100 and 300 mg, respectively, in PROMISE-2. ","['Patients who received', 'patients with migraine', 'patients with episodic or chronic migraine']","['placebo', 'eptinezumab 100\xa0mg, eptinezumab 300\xa0mg, or placebo in PROMISE-1 (episodic migraine; 100\xa0mg, n\xa0=\xa0221; 300\xa0mg, n\xa0=\xa0222; placebo, n\xa0=\xa0222) or PROMISE-2 (chronic migraine; 100\xa0mg, n\xa0=\xa0356; 300\xa0mg, n\xa0=\xa0350; placebo', 'eptinezumab']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4694272', 'cui_str': 'eptinezumab'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C4517735', 'cui_str': '350'}]",[],366.0,0.120811,"The difference from placebo (95% confidence interval) in day 1 treatment effect was -2.2 (-4.1, -0.3) and -2.5 (-4.4, -0.6) days/month for eptinezumab 100 and 300 mg, respectively, in PROMISE-1, and was -3.8 (-5.6, -2.0) and -4.0 (-5.8, -2.1) days/month for 100 and 300 mg, respectively, in PROMISE-2. ","[{'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': 'Mayo Clinic Arizona, Mayo Clinic Arizona, Scottsdale, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Gottschalk', 'Affiliation': 'Yale Neurology, New Haven, CT, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Cady', 'Affiliation': 'Lundbeck Seattle BioPharmaceuticals, Inc., Bothell, WA, USA.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Hirman', 'Affiliation': 'Pacific Northwest Statistical Consulting, Inc., Woodinville, WA, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Lundbeck Seattle BioPharmaceuticals, Inc., Bothell, WA, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Snapinn', 'Affiliation': 'Lundbeck Seattle BioPharmaceuticals, Inc., Bothell, WA, USA.'}]",Headache,['10.1111/head.14007'] 1038,33165964,Levodopa Versus Dopamine Agonist after Subthalamic Stimulation in Parkinson's Disease.,"BACKGROUND No clinical trials have been specifically designed to compare medical treatments after surgery in Parkinson's disease (PD). OBJECTIVE Study's objective was to compare the efficacy and safety of levodopa versus dopamine agonist monotherapy after deep brain stimulation (DBS) in PD. METHODS Thirty-five surgical candidates were randomly assigned to receive postoperative monotherapy with either levodopa or dopamine agonist in a randomized, single-blind study. All patients were reevaluated in short- (3 months), mid- (6 months), and long-term (2.5 years) follow-up after surgery. The primary outcome measure was the change in the Non-Motor Symptoms Scale (NMSS) 3 months after surgery. Secondary outcome measures were the percentage of patients maintaining monotherapy, change in motor symptoms, and specific non-motor symptoms (NMS). Analysis was performed primarily in the intention-to-treat population. RESULTS Randomization did not significantly affect the primary outcome (difference in NMSS between treatment groups was 4.88 [95% confidence interval: -11.78-21.53, P = 0.566]). In short- and mid-term follow-up, monotherapy was safe and feasible in more than half of patients (60% in short- and 51.5% in mid-term follow-up), but it was more often possible for patients on levodopa. The ability to maintain dopamine agonist monotherapy was related to optimal contact location. In the long term, levodopa monotherapy was feasible only in a minority of patients (34.2%), whereas dopamine agonist monotherapy was not tolerated due to worsening of motor conditions or occurrence of impulse control disorders. CONCLUSIONS This trial provides evidence for simplifying pharmacological treatment after functional neurosurgery for PD. The reduction in dopamine receptor agonists should be attempted while monitoring for occurrence of NMSs, such as apathy and sleep disturbances. © 2020 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.",2021,"In the long term, levodopa monotherapy was feasible only in a minority of patients (34.2%), whereas dopamine agonist monotherapy was not tolerated due to worsening of motor conditions or occurrence of impulse control disorders. ","[""Parkinson's disease (PD"", ""Parkinson's Disease"", '2020', 'Thirty-five surgical candidates']","['dopamine agonist monotherapy', 'Levodopa Versus Dopamine Agonist', 'levodopa monotherapy', 'levodopa versus dopamine agonist monotherapy', 'levodopa or dopamine agonist', 'postoperative monotherapy']","['efficacy and safety', 'percentage of patients maintaining monotherapy, change in motor symptoms, and specific non-motor symptoms (NMS', 'change in the Non-Motor Symptoms Scale (NMSS', 'NMSS']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0027849', 'cui_str': 'Neuroleptic malignant syndrome'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",35.0,0.152072,"In the long term, levodopa monotherapy was feasible only in a minority of patients (34.2%), whereas dopamine agonist monotherapy was not tolerated due to worsening of motor conditions or occurrence of impulse control disorders. ","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Picillo', 'Affiliation': 'Department of Medicine, Surgery and Dentistry, Neuroscience Section, Centre for Neurodegenerative Diseases (CEMAND), University of Salerno, Salerno, Italy.'}, {'ForeName': 'Onanong', 'Initials': 'O', 'LastName': 'Phokaewvarangkul', 'Affiliation': ""Department of Medicine, Faculty of Medicine, Chulalongkorn Centre of Excellence for Parkinson's Disease & Related Disorders, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand.""}, {'ForeName': 'Yu-Yan', 'Initials': 'YY', 'LastName': 'Poon', 'Affiliation': ""Edmond J. Safra Program in Parkinson's Disease, Morton and Gloria Shulman Movement Disorders Clinic, Toronto Western Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Cameron C', 'Initials': 'CC', 'LastName': 'McIntyre', 'Affiliation': 'Department of Biomedical Engineering, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Sinem Balta', 'Initials': 'SB', 'LastName': 'Beylergil', 'Affiliation': 'Department of Biomedical Engineering, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Renato P', 'Initials': 'RP', 'LastName': 'Munhoz', 'Affiliation': ""Edmond J. Safra Program in Parkinson's Disease, Morton and Gloria Shulman Movement Disorders Clinic, Toronto Western Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Suneil K', 'Initials': 'SK', 'LastName': 'Kalia', 'Affiliation': 'Krembil Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Hodaie', 'Affiliation': 'Krembil Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Andres M', 'Initials': 'AM', 'LastName': 'Lozano', 'Affiliation': 'Krembil Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Fasano', 'Affiliation': ""Edmond J. Safra Program in Parkinson's Disease, Morton and Gloria Shulman Movement Disorders Clinic, Toronto Western Hospital, Toronto, Ontario, Canada.""}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.28382'] 1039,33168369,Surgical morbidities of sagittal split ramus osteotomy versus intraoral vertical ramus osteotomy for the correction of mandibular prognathism: a randomized clinical trial.,"The sagittal split ramus osteotomy (SSRO) and intraoral vertical ramus osteotomy (IVRO) are two common orthognathic procedures for the treatment of mandibular prognathism. This randomized clinical trial compared the surgical morbidities between SSRO and IVRO for patients with mandibular prognathism over the first 2 years postoperative. Ninety-eight patients (40 male, 58 female) with a mean age of 24.4±3.5 years underwent bilateral SSRO (98 sides) or IVRO (98 sides) as part or all of their orthognathic surgery. IVRO presented less short-term and long-term surgical morbidity in general. The SSRO group had a greater incidence of inferior alveolar nerve deficit at all follow-up time points (P< 0.01). There was more TMJ pain at 6 weeks (P= 0.047) and 3 months (P= 0.001) postoperative in the SSRO group. The SSRO group also presented more minor complications, which were related to titanium plate exposure and infection. There were no major complications for either technique in this study. Despite the need for intermaxillary fixation, IVRO appears to be associated with less surgical morbidity than SSRO when performed as a mandibular setback procedure to treat mandibular prognathism.",2020,There was more TMJ pain at 6 weeks (P= 0.047) and 3 months (P= 0.001) postoperative in the SSRO group.,"['mandibular prognathism', 'patients with mandibular prognathism over the first 2 years postoperative', 'Ninety-eight patients (40 male, 58 female) with a mean age of 24.4±3.5 years underwent bilateral SSRO (98 sides) or IVRO (98 sides) as part or all of their orthognathic surgery']","['sagittal split ramus osteotomy versus intraoral vertical ramus osteotomy', 'SSRO and IVRO', 'sagittal split ramus osteotomy (SSRO) and intraoral vertical ramus osteotomy (IVRO']","['TMJ pain', 'surgical morbidity', 'incidence of inferior alveolar nerve deficit', 'titanium plate exposure and infection', 'IVRO presented less short-term and long-term surgical morbidity']","[{'cui': 'C0399526', 'cui_str': 'Malocclusion, Angle class III'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C3178772', 'cui_str': 'Sagittal Split Ramus Osteotomy'}, {'cui': 'C0441987', 'cui_str': 'Side'}, {'cui': 'C0442119', 'cui_str': 'Intraoral approach'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0185624', 'cui_str': 'Orthognathic Surgery'}]","[{'cui': 'C3178772', 'cui_str': 'Sagittal Split Ramus Osteotomy'}, {'cui': 'C0442119', 'cui_str': 'Intraoral approach'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}]","[{'cui': 'C0155943', 'cui_str': 'Arthralgia of temporomandibular joint'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0162406', 'cui_str': 'Structure of inferior alveolar nerve'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0442119', 'cui_str': 'Intraoral approach'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205166', 'cui_str': 'Long'}]",98.0,0.0549962,There was more TMJ pain at 6 weeks (P= 0.047) and 3 months (P= 0.001) postoperative in the SSRO group.,"[{'ForeName': 'Y Y', 'Initials': 'YY', 'LastName': 'Leung', 'Affiliation': 'Oral and Maxillofacial Surgery, Faculty of Dentistry, The University of Hong Kong, Hong Kong. Electronic address: mikeyyleung@hku.hk.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Oral and Maxillofacial Surgery, Faculty of Dentistry, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'N S M', 'Initials': 'NSM', 'LastName': 'Wong', 'Affiliation': 'Oral and Maxillofacial Surgery, Faculty of Dentistry, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'D T S', 'Initials': 'DTS', 'LastName': 'Li', 'Affiliation': 'Oral and Maxillofacial Surgery, Faculty of Dentistry, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'S W', 'Initials': 'SW', 'LastName': 'Au', 'Affiliation': 'Oral and Maxillofacial Surgery, Faculty of Dentistry, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'W S', 'Initials': 'WS', 'LastName': 'Choi', 'Affiliation': 'Oral and Maxillofacial Surgery, Faculty of Dentistry, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Y-X', 'Initials': 'YX', 'LastName': 'Su', 'Affiliation': 'Oral and Maxillofacial Surgery, Faculty of Dentistry, The University of Hong Kong, Hong Kong.'}]",International journal of oral and maxillofacial surgery,['10.1016/j.ijom.2020.06.023'] 1040,33169543,Early plaque formation on PTFE membranes with expanded or dense surface structures applied in the oral cavity of human volunteers.,"OBJECTIVES This clinical randomized study aimed to evaluate the early plaque formation on nonresorbable polytetrafluoroethylene (PTFE) membranes having either a dense (d-PTFE) or an expanded (e-PTFE) microstructure and exposed to the oral cavity. MATERIAL AND METHODS Twelve individuals were enrolled in this study. In a split-mouth design, five test membranes (e-PTFE) with a dual-layer configuration and five control membranes (d-PTFE) were bonded on the buccal surfaces of posterior teeth of each subject. All study subjects refrained from toothbrushing during the study period. Specimens were detached from the teeth at 4 and 24 hr and subjected to viability counting, confocal microscopy, and scanning electron microscopy. Plaque samples were harvested from neighboring teeth at baseline, 4, and 24 hr, as control. Wilcoxon signed rank test was applied. RESULTS No bond failure of the membranes was reported. Between the early and late time points, viable bacterial counts increased on all membranes, with no difference between the test and control. The number of Staphylococcus spp. decreased on the tooth surfaces and increased on both membranes overtime, with a significant difference compared to teeth. The total biomass and average biofilm thickness of live and dead cells were significantly greater at the d-PTFE barriers after 4 hr. CONCLUSION This study demonstrated that the e-PTFE membrane was associated with a lesser degree of biofilm accumulation during the initial exposure compared to the d-PTFE membrane. The present experimental setup provides a valuable toolbox to study the in vivo behavior of different membranes used in guided bone regeneration (GBR).",2021,"Between the early and late time points, viable bacterial counts increased on all membranes, with no difference between the test and control.","['human volunteers', 'Twelve individuals were enrolled in this study']",['nonresorbable polytetrafluoroethylene (PTFE) membranes having either a dense (d-PTFE'],"['biofilm accumulation', 'number of Staphylococcus spp', 'viable bacterial counts', 'total biomass and average biofilm thickness of live and dead cells']","[{'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032611', 'cui_str': 'Polytetrafluoroethylene'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0439794', 'cui_str': 'Dense'}]","[{'cui': 'C0081786', 'cui_str': 'Biofilm'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0038170', 'cui_str': 'Staphylococcus'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0004618', 'cui_str': 'Bacterial count'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005535', 'cui_str': 'Biomass'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]",12.0,0.0256815,"Between the early and late time points, viable bacterial counts increased on all membranes, with no difference between the test and control.","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Turri', 'Affiliation': 'Department of Biomaterials, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Emina', 'Initials': 'E', 'LastName': 'Čirgić', 'Affiliation': 'Department of Orthodontics, University Clinics of Odontology, Public Dental Service, Region Västra Götaland, Gothenburg, Sweden.'}, {'ForeName': 'Furqan A', 'Initials': 'FA', 'LastName': 'Shah', 'Affiliation': 'Department of Biomaterials, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hoffman', 'Affiliation': 'Department of Biomaterials, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Omar', 'Affiliation': 'Vice Deanship for Postgraduate Studies and Scientific Research, College of Dentistry, Imam Abdulrahman bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Christer', 'Initials': 'C', 'LastName': 'Dahlin', 'Affiliation': 'Department of Biomaterials, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Trobos', 'Affiliation': 'Department of Biomaterials, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",Clinical and experimental dental research,['10.1002/cre2.344'] 1041,33172094,The Effectiveness of the Foodbot Factory Mobile Serious Game on Increasing Nutrition Knowledge in Children.,"The interactive and engaging nature of serious games (i.e., video games designed for educational purposes) enables deeper learning and facilitates behavior change; however, most do not specifically support the dissemination of national dietary guidelines, and there are limited data on their impact on child nutrition knowledge. The Foodbot Factory serious game mobile application was developed to support school children in learning about Canada's Food Guide; however, its impacts on nutrition knowledge have not been evaluated. The objective of this study was to determine if Foodbot Factory effectively improves children's knowledge of Canada's Food Guide, compared to a control group (control app). This study was a single-blinded, parallel, randomized controlled pilot study conducted among children ages 8-10 years attending Ontario Tech University day camps. Compared to the control group ( n = 34), children who used Foodbot Factory ( n = 39) had significant increases in overall nutrition knowledge (10.3 ± 2.9 to 13.5 ± 3.8 versus 10.2 ± 3.1 to 10.4 ± 3.2, p < 0.001), and in Vegetables and Fruits ( p < 0.001), Protein Foods ( p < 0.001), and Whole Grain Foods ( p = 0.040) sub-scores. No significant difference in knowledge was observed in the Drinks sub-score. Foodbot Factory has the potential to be an effective educational tool to support children in learning about nutrition.",2020,No significant difference in knowledge was observed in the Drinks sub-score.,"['Children', 'children ages 8-10 years attending Ontario Tech University day camps']",['Foodbot Factory Mobile Serious Game'],"['knowledge', 'Whole Grain Foods', 'Vegetables and Fruits', 'Protein Foods', 'overall nutrition knowledge']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}]","[{'cui': 'C0442614', 'cui_str': 'Factory'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0453858', 'cui_str': 'Protein food'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}]",,0.0474905,No significant difference in knowledge was observed in the Drinks sub-score.,"[{'ForeName': 'Hannah M', 'Initials': 'HM', 'LastName': 'Froome', 'Affiliation': 'Faculty of Health Sciences, Ontario Tech University, 2000 Simcoe Street North, Oshawa, ON L1G 0C5, Canada.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Townson', 'Affiliation': 'Faculty of Health Sciences, Ontario Tech University, 2000 Simcoe Street North, Oshawa, ON L1G 0C5, Canada.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Rhodes', 'Affiliation': 'Faculty of Education, Ontario Tech University, 2000 Simcoe Street North, Oshawa, ON L1G 0C5, Canada.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Franco-Arellano', 'Affiliation': 'Faculty of Health Sciences, Ontario Tech University, 2000 Simcoe Street North, Oshawa, ON L1G 0C5, Canada.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'LeSage', 'Affiliation': 'Faculty of Education, Ontario Tech University, 2000 Simcoe Street North, Oshawa, ON L1G 0C5, Canada.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Savaglio', 'Affiliation': 'Faculty of Business and Information Technology, Ontario Tech University, 2000 Simcoe Street North, Oshawa, ON L1G 0C5, Canada.'}, {'ForeName': 'Jacqueline Marie', 'Initials': 'JM', 'LastName': 'Brown', 'Affiliation': 'Faculty of Health Sciences, Ontario Tech University, 2000 Simcoe Street North, Oshawa, ON L1G 0C5, Canada.'}, {'ForeName': 'Janette', 'Initials': 'J', 'LastName': 'Hughes', 'Affiliation': 'Faculty of Education, Ontario Tech University, 2000 Simcoe Street North, Oshawa, ON L1G 0C5, Canada.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Kapralos', 'Affiliation': 'Faculty of Business and Information Technology, Ontario Tech University, 2000 Simcoe Street North, Oshawa, ON L1G 0C5, Canada.'}, {'ForeName': 'JoAnne', 'Initials': 'J', 'LastName': 'Arcand', 'Affiliation': 'Faculty of Health Sciences, Ontario Tech University, 2000 Simcoe Street North, Oshawa, ON L1G 0C5, Canada.'}]",Nutrients,['10.3390/nu12113413'] 1042,33175637,Safety and immunogenicity of a new Sabin inactivated poliovirus vaccine candidate produced on the PER.C6® cell-line: a phase 1 randomized controlled trial in adults.,"This first-in-human study (NCT03032588), conducted in Belgium, evaluated a new inactivated poliovirus vaccines (IPV) candidate based on Sabin poliovirus strains grown on the high-yield PER.C6® cell line. Healthy adults (N = 32) were randomized (1:1) to receive a single dose of PER.C6-based Sabin-IPV (sIPV, 15:35:112.5 DU/dose) or conventional Salk-IPV (cIPV, 40:8:32 DU/dose). Reactogenicity was assessed up to 7 days after vaccination, immunogenicity 28 days after vaccination, and safety up to 6 months after vaccination.Solicited adverse events (AEs) were mild to moderate, no changes of concern in vital signs or safety laboratory values were observed, and no severe AEs (SAEs) or vaccine-related unsolicited AEs were reported after vaccination. A trend to more frequent solicited AEs after sIPV than after cIPV administration was observed. Most participants had preexisting neutralizing antibodies against poliovirus types (titer ≥8), which were strongly boosted by sIPV. Post-vaccination geometric mean titers were high (≥12,000) and similar across the two vaccination groups. Only participants with very high preexisting antibody levels did not show a vaccine-induced response, defined in seropositive participants as a 4-fold titer increase. The 10 initially seronegative (titer <8) participants (n = 5 in each study group) seroconverted and all participants had seroprotective antibody levels post-vaccination. The antibodies elicited by sIPV neutralized both Sabin and Salk poliovirus strains.In conclusion, the PER.C6®-based sIPV was well tolerated and highly immunogenic in adults with preexisting antibodies to poliovirus.",2021,"Solicited adverse events (AEs) were mild to moderate, no changes of concern in vital signs or safety laboratory values were observed, and no severe AEs (SAEs) or vaccine-related unsolicited AEs were reported after vaccination.","['adults', 'Healthy adults (N\xa0=\xa032', 'adults with preexisting antibodies to poliovirus']","['new Sabin inactivated poliovirus vaccine candidate', 'PER.C6-based Sabin-IPV (sIPV, 15:35:112.5 DU/dose) or conventional Salk-IPV (cIPV, 40:8:32']","['Safety and immunogenicity', 'vital signs or safety laboratory values', 'Reactogenicity', 'seroprotective antibody levels post-vaccination']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0206435', 'cui_str': 'Human poliovirus'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0036106', 'cui_str': 'Salk Vaccine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",32.0,0.101606,"Solicited adverse events (AEs) were mild to moderate, no changes of concern in vital signs or safety laboratory values were observed, and no severe AEs (SAEs) or vaccine-related unsolicited AEs were reported after vaccination.","[{'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Leroux-Roels', 'Affiliation': 'Center for Vaccinology, Ghent University and Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Leroux-Roels', 'Affiliation': 'Center for Vaccinology, Ghent University and Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Georgi', 'Initials': 'G', 'LastName': 'Shukarev', 'Affiliation': 'Janssen Vaccines AG, Bern, Switzerland.'}, {'ForeName': 'Hanneke', 'Initials': 'H', 'LastName': 'Schuitemaker', 'Affiliation': 'Janssen Vaccines & Prevention B.V., Leiden, The Netherlands.'}, {'ForeName': 'Conor', 'Initials': 'C', 'LastName': 'Cahill', 'Affiliation': 'Takeda Pharmaceuticals, Zurich, Switzerland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'de Rooij', 'Affiliation': 'Takeda Pharmaceuticals, Zurich, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Struijs', 'Affiliation': 'Janssen Vaccines & Prevention B.V., Leiden, The Netherlands.'}, {'ForeName': 'Hester', 'Initials': 'H', 'LastName': 'van Zeeburg', 'Affiliation': 'DCPrime BV, Leiden the Netherlands.'}, {'ForeName': 'Jeanne-Marie', 'Initials': 'JM', 'LastName': 'Jacquet', 'Affiliation': 'Janssen Vaccines & Prevention B.V., Leiden, The Netherlands.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2020.1812315'] 1043,33175656,Durability of response to VGX-3100 treatment of HPV16/18 positive cervical HSIL.,"VGX-3100 is an investigational DNA-based immunotherapy being developed as an alternative to surgery and ablation for cervical High-Grade Squamous Intraepithelial Lesion (HSIL) with the aim of preserving reproductive health while treating precancerous disease. Response durability up to 1.5 y following dosing is now reported.Histologic regression and HPV16 and/or HPV 18 (HPV16/18) clearance were previously demonstrated in a randomized, placebo-controlled, double-blind trial and reported for 6 months after the last dose of VGX-3100 or placebo. The presence of HPV16/18, Pap smear diagnoses, and immunogenicity longer-term responses were assessed at 18 months after the last dose.91% (32/35) VGX-3100-treated women, whose cervical HSIL regressed and avoided excision at 6 months following study treatment completion, had no detectable HPV16/18 at 18 months following treatment completion. These results were comparable to those for women who received placebo and then later underwent surgery. For VGX-3100 recipients who regressed at 6 months following study treatment completion and avoided excision during the trial, Pap testing showed no HSIL recurrence at 18 months following VGX-3100 treatment. VGX-3100-induced cellular immune responses specific for HPV 16/18 E6/E7 remained higher than for placebo control recipients at 18 months.In women with cervical HSIL who responded to VGX-3100 and were able to avoid surgery, clinical outcomes were comparable to the placebo control group which underwent conventional surgical treatment. These findings extend the understanding of the durability of the treatment effect of VGX-3100 up to 1.5 y and support that VGX-3100 could be used as an alternative to surgery.",2021,VGX-3100-induced cellular immune responses specific for HPV 16/18 E6/E7 remained higher than for placebo control recipients at 18 months.,"['HPV16/18 positive cervical HSIL', 'women with cervical HSIL']","['VGX-3100', 'placebo', 'conventional surgical treatment', 'VGX-3100 or placebo']","['cervical HSIL regressed and avoided excision', 'Response durability', 'HSIL recurrence', 'presence of HPV16/18, Pap smear diagnoses, and immunogenicity longer-term responses', 'Histologic regression and HPV16 and/or HPV 18 (HPV16/18) clearance', 'VGX-3100-induced cellular immune responses specific']","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1512433', 'cui_str': 'Cervical high grade squamous intraepithelial lesion'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C2703096', 'cui_str': 'VGX-3100'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C1512433', 'cui_str': 'Cervical high grade squamous intraepithelial lesion'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0333875', 'cui_str': 'High-grade squamous intraepithelial lesion'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0079104', 'cui_str': 'Smear cervix'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0999807', 'cui_str': 'Human papillomavirus, type 18'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C2703096', 'cui_str': 'VGX-3100'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1817908', 'cui_str': 'Cellular Immune Response'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",,0.12244,VGX-3100-induced cellular immune responses specific for HPV 16/18 E6/E7 remained higher than for placebo control recipients at 18 months.,"[{'ForeName': 'Prakash K', 'Initials': 'PK', 'LastName': 'Bhuyan', 'Affiliation': 'Inovio Pharmaceuticals, Inc., Plymouth Meeting, PA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dallas', 'Affiliation': 'Inovio Pharmaceuticals, Inc., Plymouth Meeting, PA, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Kraynyak', 'Affiliation': 'Inovio Pharmaceuticals, Inc., Plymouth Meeting, PA, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Herring', 'Affiliation': 'Inovio Pharmaceuticals, Inc., Plymouth Meeting, PA, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Morrow', 'Affiliation': 'Inovio Pharmaceuticals, Inc., Plymouth Meeting, PA, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Boyer', 'Affiliation': 'Inovio Pharmaceuticals, Inc., Plymouth Meeting, PA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Duff', 'Affiliation': 'Inovio Pharmaceuticals, Inc., Plymouth Meeting, PA, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Inovio Pharmaceuticals, Inc., Plymouth Meeting, PA, USA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Weiner', 'Affiliation': 'Wistar Institute, Philadelphia, PA, USA.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2020.1823778'] 1044,33179323,Reversion From Chronic Migraine to Episodic Migraine in Patients Treated With Fremanezumab: Post Hoc Analysis From HALO CM Study.,"BACKGROUND Migraine preventive medications are used to reduce headache frequency, severity, and duration. In patients with chronic migraine (CM), reversion to episodic migraine (EM) is an important treatment goal. OBJECTIVE To evaluate the effect of fremanezumab on the rate of reversion from CM to EM. METHODS This phase 3, randomized, double-blind, placebo-controlled, parallel-group trial included a 28-day pretreatment period and a 3-month treatment period. Patients with CM received subcutaneous fremanezumab quarterly (675 mg at baseline) or monthly (675 mg at baseline; 225 mg at Weeks 4 and 8), or placebo. Post hoc analyses evaluated the proportion of patients who reverted from CM to EM, defined as either a reduction to an average of <15 headache days per month during the 3-month treatment period or a reduction to <15 headache days per month in all 3 months of the treatment period. RESULTS This analysis included data from 1088 CM patients (quarterly, n = 366; monthly, n = 365; placebo, n = 357). More fremanezumab-treated patients with CM reverted to EM using either the monthly average number of headache days criteria for reversion (quarterly: 50.5% [185/366], P = .108; monthly: 53.7% [196/365], P = .012; vs placebo: 44.5% [159/357]) or the monthly headache day count at Months 1, 2, and 3 criteria for reversion (quarterly: 31.2% [114/366], P = .008; monthly: 33.7% [123/365], P = .001; vs placebo: 22.4% [80/357]). Patients with CM who reported previous topiramate or onabotulinumtoxinA use, concomitant preventive medication use, or medication overuse were less likely to revert to EM. CONCLUSIONS Fremanezumab may offer the benefit of reversion from CM to EM, based on a reduction in the number of headache days over 3 months of treatment.",2020,"More fremanezumab-treated patients with CM reverted to EM using either the monthly average number of headache days criteria for reversion (quarterly: 50.5% [185/366], P = .108; monthly: 53.7% [196/365], P = .012; vs placebo: 44.5% [159/357]) or the monthly headache day count at Months 1, 2, and 3 criteria for reversion (quarterly: 31.2% [114/366], P = .008; monthly: 33.7% [123/365], P = .001; vs placebo: 22.4% [80/357]).","['patients with chronic migraine (CM), reversion to episodic migraine (EM', '1088 CM patients (quarterly, n\xa0=\xa0366; monthly, n\xa0=\xa0365; placebo, n\xa0=\xa0357', 'Patients with CM who reported previous topiramate or onabotulinumtoxinA use, concomitant preventive medication use, or medication overuse were less likely to revert to EM', 'Patients']","['Fremanezumab', 'placebo', 'fremanezumab', 'subcutaneous fremanezumab']",['monthly headache day count'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0076829', 'cui_str': 'topiramate'}, {'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3266697', 'cui_str': 'Medication overuse'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}]","[{'cui': 'C4549503', 'cui_str': 'fremanezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",,0.19887,"More fremanezumab-treated patients with CM reverted to EM using either the monthly average number of headache days criteria for reversion (quarterly: 50.5% [185/366], P = .108; monthly: 53.7% [196/365], P = .012; vs placebo: 44.5% [159/357]) or the monthly headache day count at Months 1, 2, and 3 criteria for reversion (quarterly: 31.2% [114/366], P = .008; monthly: 33.7% [123/365], P = .001; vs placebo: 22.4% [80/357]).","[{'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Cohen', 'Affiliation': 'Teva Pharmaceutical Industries Ltd., Frazer, PA, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Bibeau', 'Affiliation': 'Teva Pharmaceutical Industries Ltd., Frazer, PA, USA.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Galic', 'Affiliation': 'Teva Pharmaceutical Industries Ltd., Amsterdam, The Netherlands.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Seminerio', 'Affiliation': 'Teva Pharmaceutical Industries Ltd., Frazer, PA, USA.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Ramirez Campos', 'Affiliation': 'Teva Pharmaceutical Industries Ltd., Frazer, PA, USA.'}, {'ForeName': 'Rashmi B', 'Initials': 'RB', 'LastName': 'Halker Singh', 'Affiliation': 'Mayo Clinic, Phoenix, AZ, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ailani', 'Affiliation': 'MedStar Georgetown University Hospital, Washington, DC, USA.'}]",Headache,['10.1111/head.13997'] 1045,33181580,"A randomized, controlled trial of a β2-agonist in painful polyneuropathy.","ABSTRACT Experimental data have suggested that in neuropathic pain, tricyclic antidepressants may work solely through a β2-agonist action. The aim of this study was to test if the β2-agonist terbutaline relieves painful polyneuropathy. The study was a randomized, double-blind, placebo-controlled and active-controlled, 3-way, cross-over trial among patients with painful polyneuropathy. The treatment periods were of 5 weeks' duration and were preceded by 1 week for washout and 1 week for baseline observations. The patients received terbutaline (5-15 mg), imipramine (30-150 mg), or placebo in a random order. Drug doses depended on age and metabolizer status. The change in total pain recorded from ratings in diaries (numeric rating scale [NRS] 0-10) was the primary outcome, and the change in rating of specific pain symptoms (NRS 0-10), patient global impression of change, and sleep disturbance were secondary outcomes. Forty-seven patients were randomized. The median score for total pain changed from NRS 6.4 to 6.1 from baseline to week 5 on terbutaline with an average effect during the treatment period as compared with placebo of 0.13 (95% confidence interval -0.12 to 0.38, P = 0.32). The median score for total pain on imipramine changed from NRS 6.6 to 4.8 with an average effect as compared with placebo of -1.17 (95% confidence interval -1.42 to -0.92, P < 0.001). Secondary outcomes were also unaltered by terbutaline but improved by imipramine. The β2-agonist terbutaline has no effect in painful polyneuropathy. β2-agonism seems not to be an important mechanism of action of tricyclic antidepressants in neuropathic pain.",2021,Median score for total pain on imipramine changed from NRS 6.6 to 4.8 with an average effect as compared to placebo of -1.17,"['Forty-seven patients were randomized', 'patients with painful polyneuropathy', 'painful polyneuropathy']","['imipramine', 'β2-agonist terbutaline', 'placebo', 'terbutaline']","['rating of specific pain symptoms (NRS 0-10), patient global impression of change and sleep disturbance', 'total pain', 'painful polyneuropathy', 'Median score for total pain']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}]","[{'cui': 'C0020934', 'cui_str': 'Imipramine'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0039542', 'cui_str': 'Terbutaline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",47.0,0.547855,Median score for total pain on imipramine changed from NRS 6.6 to 4.8 with an average effect as compared to placebo of -1.17,"[{'ForeName': 'Mimmi', 'Initials': 'M', 'LastName': 'Gillving', 'Affiliation': 'Department of Neurology and Neurology Research Unit, Odense University Hospital and University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Dyveke', 'Initials': 'D', 'LastName': 'Demant', 'Affiliation': 'Department of Neurology and Neurology Research Unit, Odense University Hospital and University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Jakob V', 'Initials': 'JV', 'LastName': 'Holbech', 'Affiliation': 'Department of Neurology and Neurology Research Unit, Odense University Hospital and University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Sandra Sif', 'Initials': 'SS', 'LastName': 'Gylfadottir', 'Affiliation': 'Danish Pain Research Center, Department of Clinical Medicine, Aarhus University, and Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Flemming W', 'Initials': 'FW', 'LastName': 'Bach', 'Affiliation': 'Danish Pain Research Center, Department of Clinical Medicine, Aarhus University, and Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Troels S', 'Initials': 'TS', 'LastName': 'Jensen', 'Affiliation': 'Danish Pain Research Center, Department of Clinical Medicine, Aarhus University, and Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Nanna B', 'Initials': 'NB', 'LastName': 'Finnerup', 'Affiliation': 'Danish Pain Research Center, Department of Clinical Medicine, Aarhus University, and Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Søren H', 'Initials': 'SH', 'LastName': 'Sindrup', 'Affiliation': 'Department of Neurology and Neurology Research Unit, Odense University Hospital and University of Southern Denmark, Odense, Denmark.'}]",Pain,['10.1097/j.pain.0000000000002140'] 1046,33181328,Randomized controlled open label trial on the use of favipiravir combined with inhaled interferon beta-1b in hospitalized patients with moderate to severe COVID-19 pneumonia.,"OBJECTIVE To evaluate the therapeutic effectiveness of favipiravir combined with inhaled interferon beta-1b in adult patients hospitalized with moderate to severe COVID-19 pneumonia. METHODS A randomized, open-label controlled trial of oral favipiravir in adults hospitalized with moderate to severe COVID-19 pneumonia from June 22nd 2020 to August 13th 2020 was conducted. Patients were randomly assigned to receive either a combination of favipiravir with interferon beta-1b by inhalation aerosol or hydroxychloroquine (HCQ). The outcome endpoints included improvement in inflammatory markers, lower length of hospital stay (LOS), discharges and lower overall 14-day mortality. RESULTS A total of 89 patients underwent randomization with 49% (n = 44) assigned to favipiravir and 51% (n = 45) assigned HCQ. The overall mean age was 55 ± 14 years and 58% (n = 52) were males. There were no significant differences in the inflammatory biomarkers at hospital discharge between the two groups; C-reactive protein (p = 0.413), ferritin (p = 0.968), lactate dehydrogenase (p = 0.259) and interleukin 6 (p = 0.410). There were also no significant differences between the two groups with regards to the overall LOS (7 vs 7 days; p = 0.948), transfers to the ICU (18.2% vs 17.8%; p = 0.960), discharges (65.9% vs 68.9%; p = 0.764) and overall mortality (11.4% vs 13.3%; p = 0.778). CONCLUSIONS No differences in clinical outcomes were found between favipiravir plus inhaled interferon beta-1b and hydroxychloroquine in adults hospitalized with moderate to severe COVID-19 pneumonia.",2021,No differences in clinical outcomes were found between favipiravir plus inhaled interferon beta-1b and hydroxychloroquine in adults hospitalized with moderate to severe COVID-19 pneumonia.,"['89 patients underwent randomization with 49% (n\u2009=\u200944) assigned to', 'adult patients hospitalized with moderate to severe COVID-19 pneumonia', 'Hospitalized Patients with Moderate to Severe COVID-19 Pneumonia', 'adults hospitalized with moderate to severe COVID-19 pneumonia', 'The overall mean age was 55\u2009±\u200914 years and 58% (n\u2009=\u200952) were males', 'adults hospitalized with moderate to severe COVID-19 pneumonia from June 22 nd 2020 to August 13 th 2020 was conducted']","['favipiravir', 'hydroxychloroquine', 'oral favipiravir', 'Favipiravir Combined with Inhaled Interferon', 'favipiravir combined with inhaled interferon', 'HCQ', 'favipiravir with interferon beta-1b by inhalation aerosol or hydroxychloroquine (HCQ']","['lactate dehydrogenase', 'transfers to the ICU', 'improvement in inflammatory markers, lower length of hospital stay (LOS), discharges and lower overall 14-day mortality', 'inflammatory biomarkers at hospital discharge', 'overall mortality', 'therapeutic effectiveness', 'overall LOS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C1138226', 'cui_str': 'favipiravir'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0244713', 'cui_str': 'interferon beta-1b'}, {'cui': 'C0001712', 'cui_str': 'Aerosol'}]","[{'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",89.0,0.130415,No differences in clinical outcomes were found between favipiravir plus inhaled interferon beta-1b and hydroxychloroquine in adults hospitalized with moderate to severe COVID-19 pneumonia.,"[{'ForeName': 'Faryal', 'Initials': 'F', 'LastName': 'Khamis', 'Affiliation': 'Infection Diseases Unit, Department of Medicine, Royal Hospital, Muscat, Oman. Electronic address: khami001@gmail.com.'}, {'ForeName': 'Hanan', 'Initials': 'H', 'LastName': 'Al Naabi', 'Affiliation': 'Acute Medicine Unit, Department of Medicine, Royal Hospital, Muscat, Oman. Electronic address: Hananhamed4141@gmail.com.'}, {'ForeName': 'Adil', 'Initials': 'A', 'LastName': 'Al Lawati', 'Affiliation': 'Acute Medicine Unit, Department of Medicine, Royal Hospital, Muscat, Oman. Electronic address: dr.fadhlani@hotmail.com.'}, {'ForeName': 'Zaiyana', 'Initials': 'Z', 'LastName': 'Ambusaidi', 'Affiliation': 'Acute Medicine Unit, Department of Medicine, Royal Hospital, Muscat, Oman. Electronic address: z_ambusaidi@hotmail.com.'}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Al Sharji', 'Affiliation': 'Department of Nursing, Royal Hospital, Muscat, Oman. Electronic address: Hoodmood7@gmail.com.'}, {'ForeName': 'Umkulthum', 'Initials': 'U', 'LastName': 'Al Barwani', 'Affiliation': 'Department of Pharmacy, Royal Hospital, Muscat, Oman. Electronic address: umkulthum@yahoo.com.'}, {'ForeName': 'Nenad', 'Initials': 'N', 'LastName': 'Pandak', 'Affiliation': 'Infection Diseases Unit, Department of Medicine, Royal Hospital, Muscat, Oman. Electronic address: npandak@gmail.com.'}, {'ForeName': 'Zakariya', 'Initials': 'Z', 'LastName': 'Al Balushi', 'Affiliation': 'Infection Diseases Unit, Department of Medicine, Royal Hospital, Muscat, Oman. Electronic address: zak077@gmail.com.'}, {'ForeName': 'Maher', 'Initials': 'M', 'LastName': 'Al Bahrani', 'Affiliation': 'Department of Anesthesia and Critical Care, Royal Hospital, Muscat, Oman. Electronic address: dr.mjalbahrani@gmail.com.'}, {'ForeName': 'Issa', 'Initials': 'I', 'LastName': 'Al Salmi', 'Affiliation': 'Department of Nephrology, Royal Hospital, Muscat, Oman. Electronic address: isa.al.salmi@gmail.com.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Al-Zakwani', 'Affiliation': 'Department of Pharmacology & Clinical Pharmacy, College of Medicine & Clinical Pharmacy, Sultan Qaboos University, Muscat, Oman. Electronic address: ial_zakwani@yahoo.com.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.11.008'] 1047,33188552,Bergamot phytosome improved visceral fat and plasma lipid profiles in overweight and obese class I subject with mild hypercholesterolemia: A randomized placebo controlled trial.,"Bergamot has been traditionally used for the relief of diseases related to oxidative stress. Our aim was to investigate the effect of bergamot phytosome on visceral adipose tissue (VAT) and on metabolic profile, in overweight and obese subjects with mild hypercholesterolemia. A total of 64 participants were randomized into two groups for 12 weeks: a supplemented group (33 individuals, BMI 27 ± 3 kg/m 2 receiving 500 mg of bergamot phytosome, two daily tablets) and placebo group (31 subjects, BMI 28 ± 3 kg/m 2 , two daily tablets). As to the within differences, the parameters of VAT, total and LDL-cholesterol were significantly decreased in the bergamot phytosome group, but not in the placebo group. As to between-group differences, a statistically significant interaction between time and group, that is, the change in score over time differs between the two groups was observed 30 days after supplementation for VAT (p-value = .005), total cholesterol (p-value <.0002), and LDL (p = .004) in respect to placebo. The other parameters (glucose, insulin, Homeostasis Model Assessment, high-density lipoprotein cholesterol, triglycerides, fat free mass, fat mass) were not significant. In conclusion, this clinical study gives evidence that bergamot phytosome provides beneficial effects, such as decrease of VAT and modulation of metabolic alterations, after just 30 days of supplementation, resulting a very promising protection of cardiovascular health.",2021,"As to the within differences, the parameters of VAT, total and LDL-cholesterol were significantly decreased in the bergamot phytosome group, but not in the placebo group.","['overweight and obese subjects with mild hypercholesterolemia', '64 participants', 'overweight and obese class I subject with mild hypercholesterolemia']","['BMI 27\u2009±\u20093 kg/m 2 receiving 500\u2009mg of bergamot phytosome, two daily tablets) and placebo', 'placebo', 'bergamot phytosome']","['visceral adipose tissue (VAT', 'parameters of VAT, total and LDL-cholesterol', 'total cholesterol', 'LDL', 'visceral fat and plasma lipid profiles', 'parameters (glucose, insulin, Homeostasis Model Assessment, high-density lipoprotein cholesterol, triglycerides, fat free mass, fat mass']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C3853264', 'cui_str': 'Obese class I'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C3715207', 'cui_str': 'Bergamot orange extract'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",64.0,0.125485,"As to the within differences, the parameters of VAT, total and LDL-cholesterol were significantly decreased in the bergamot phytosome group, but not in the placebo group.","[{'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Rondanelli', 'Affiliation': 'IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Peroni', 'Affiliation': 'Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ""Istituto Santa Margherita"", University of Pavia, Pavia, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Riva', 'Affiliation': 'Research and Development Department, Indena SpA, Milan, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Petrangolini', 'Affiliation': 'Research and Development Department, Indena SpA, Milan, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Allegrini', 'Affiliation': 'Research and Development Department, Indena SpA, Milan, Italy.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Fazia', 'Affiliation': 'Department of Brain and Behavioral Science, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Bernardinelli', 'Affiliation': 'Department of Brain and Behavioral Science, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Naso', 'Affiliation': 'Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ""Istituto Santa Margherita"", University of Pavia, Pavia, Italy.'}, {'ForeName': 'Milena Anna', 'Initials': 'MA', 'LastName': 'Faliva', 'Affiliation': 'Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ""Istituto Santa Margherita"", University of Pavia, Pavia, Italy.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Tartara', 'Affiliation': 'Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ""Istituto Santa Margherita"", University of Pavia, Pavia, Italy.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Gasparri', 'Affiliation': 'Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ""Istituto Santa Margherita"", University of Pavia, Pavia, Italy.'}, {'ForeName': 'Vittoria', 'Initials': 'V', 'LastName': 'Infantino', 'Affiliation': 'Department of Public Health, Experimental and Forensic Medicine, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Perna', 'Affiliation': 'Department of Biology, University of Bahrain, College of Science, Sakhir, Bahrain.'}]",Phytotherapy research : PTR,['10.1002/ptr.6950'] 1048,33186516,"Safety and immunogenicity of a synthetic carbohydrate conjugate vaccine against Shigella flexneri 2a in healthy adult volunteers: a phase 1, dose-escalating, single-blind, randomised, placebo-controlled study.","BACKGROUND Shigella remains in the top four pathogens responsible for moderate to severe diarrhoea in children below 5 years of age. The shigella O-specific polysaccharide (O-SP) is a promising vaccine target. We developed a conjugate vaccine prototype incorporating a unique well defined synthetic oligosaccharide hapten, chemically designed for optimal antigenic, conformational, structural, and functional mimicry of the O-SP from Shigella flexneri 2a (SF2a). We aimed to assess the safety, tolerability, and immunogenicity of this original synthetic oligosaccharide-based vaccine candidate, SF2a-TT15, conceived to drive the antibody response towards the key protective determinants of the native lipopolysaccharide antigen, in a first-in-human phase 1 study. METHODS We did a first-in-human, dose-escalating, single-blind, observer-masked, randomised, placebo-controlled study at the Clinical Research Center of Tel Aviv Sourasky Medical Center (Israel). Participants were healthy adults aged 18-45 years with low titres of serum SF2a-specific IgG antibodies. 64 eligible participants were assigned to one of two cohorts. 32 participants in each of the two cohorts were randomly assigned via computer-generated algorithm in a stepwise manner to receive the 2 μg (cohort 1) and 10 μg oligosaccharide dose (cohort 2) of the SF2a-TT15 vaccine candidate non-adjuvanted or adjuvanted with aluminium hydroxide (alum) or matching placebos. The vaccine was administered as three single intramuscular injections into the arm, 28 days apart. The primary outcome was the incidence and severity of adverse events, which were assessed in the intention-to-treat safety population analysis including all participants who were randomly assigned and received at least one vaccine or placebo injection. The immunogenicity endpoints were secondary outcomes and were analysed in all participants who were randomly assigned, received all of the assigned injections before the time of the immunogenicity assessment, and provided blood samples for immunological follow-up (per-protocol immunogenicity analysis). The study is registered with ClinicalStudies.gov, NCT02797236 and is completed. FINDINGS Of 203 volunteers initially screened, 64 participants were enrolled between Sept 20, 2016, and Sept 26, 2017. In each of the two cohorts, 12 participants received the adjuvanted vaccine, 12 received the non-adjuvanted vaccine and eight received the matching placebo (four each). The SF2a-TT15 glycoconjugate was well tolerated at both doses. No serious or severe adverse events occurred. Overall, seven (88%) of eight to 12 (100%) of 12 in each group of volunteers had one adverse event or more after receiving the study agents with the majority of adverse events, 300 (98%) of 307, considered mild in intensity. Of the seven adverse events defined as moderate in severity, one (nausea) was suspected to be related to the vaccine candidate. At all post-immunisation days and for both oligosaccharide doses, whether adjuvanted or not, SF2a-TT15 induced significantly higher serum IgG anti-SF2a lipopolysaccharide geometric mean titres (GMTs) as compared with baseline or with the corresponding GMTs in placebo recipients (p<0·01). After one injection, the non-adjuvanted 10 μg oligosaccharide dose induced a 27-times increase in IgG GMT (5080 vs 189) and the non-adjuvanted 2 μg oligosaccharide dose induced a five-times increase (1411 vs 283), compared with baseline. Alum enhanced the specific IgG response at 2 μg oligosaccharide dose after the third injection (GMTs 3200 vs 1176, p=0.045). INTERPRETATION SF2a-TT15 was safe and well tolerated and induced high titres of anti-SF2a LPS IgG antibodies. These results support further evaluation of this original synthetic oligosaccharide-protein conjugate vaccine candidate for safety, immunogenicity, and protective efficacy in target populations. FUNDING The European Union Seventh Framework Programme.",2021,"INTERPRETATION SF2a-TT15 was safe and well tolerated and induced high titres of anti-SF2a LPS IgG antibodies.","['healthy adult volunteers', '203 volunteers initially screened, 64 participants were enrolled between Sept 20, 2016, and Sept 26, 2017', '64 eligible participants', 'children below 5 years of age', '32 participants in each of the two cohorts were', 'Participants were healthy adults aged 18-45 years with low titres of serum SF2a-specific IgG antibodies']","['adjuvanted vaccine, 12 received the non-adjuvanted vaccine and eight received the matching placebo', 'synthetic carbohydrate conjugate vaccine', 'randomly assigned via computer-generated algorithm in a stepwise manner to receive the 2 μg (cohort 1) and 10 μg oligosaccharide dose (cohort 2) of the SF2a-TT15 vaccine candidate non-adjuvanted or adjuvanted with aluminium hydroxide (alum) or matching placebos', 'placebo', 'vaccine or placebo injection']","['serum IgG anti-SF2a lipopolysaccharide geometric mean titres (GMTs', '27-times increase in IgG GMT', 'Safety and immunogenicity', 'incidence and severity of adverse events', 'specific IgG response', 'safety, tolerability, and immunogenicity', 'No serious or severe adverse events']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1265139', 'cui_str': 'Shigella flexneri, serovar 2a'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1265139', 'cui_str': 'Shigella flexneri, serovar 2a'}, {'cui': 'C0002371', 'cui_str': 'Aluminum Hydroxide'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0051979', 'cui_str': 'Anti-Immunoglobulin G antibody'}, {'cui': 'C1265139', 'cui_str': 'Shigella flexneri, serovar 2a'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}]",64.0,0.493768,"INTERPRETATION SF2a-TT15 was safe and well tolerated and induced high titres of anti-SF2a LPS IgG antibodies.","[{'ForeName': 'Dani', 'Initials': 'D', 'LastName': 'Cohen', 'Affiliation': 'School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: dancohen@tauex.tau.ac.il.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Atsmon', 'Affiliation': 'School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Clinical Research Center, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Artaud', 'Affiliation': 'Centre de Recherche Translationnelle-Coordination Clinique Institut Pasteur, Paris, France.'}, {'ForeName': 'Shiri', 'Initials': 'S', 'LastName': 'Meron-Sudai', 'Affiliation': 'School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Marie-Lise', 'Initials': 'ML', 'LastName': 'Gougeon', 'Affiliation': 'Unité Immunité Innée et Virus, Institut Pasteur, Paris, France.'}, {'ForeName': 'Anya', 'Initials': 'A', 'LastName': 'Bialik', 'Affiliation': 'School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Sophy', 'Initials': 'S', 'LastName': 'Goren', 'Affiliation': 'School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Asato', 'Affiliation': 'School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Ortal', 'Initials': 'O', 'LastName': 'Ariel-Cohen', 'Affiliation': 'School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Arava', 'Initials': 'A', 'LastName': 'Reizis', 'Affiliation': 'School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Dorman', 'Affiliation': 'School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Carla W G', 'Initials': 'CWG', 'LastName': 'Hoitink', 'Affiliation': 'Intravacc, Bilthoven, Netherlands.'}, {'ForeName': 'Janny', 'Initials': 'J', 'LastName': 'Westdijk', 'Affiliation': 'Intravacc, Bilthoven, Netherlands.'}, {'ForeName': 'Shai', 'Initials': 'S', 'LastName': 'Ashkenazi', 'Affiliation': ""Adelson School of Medicine, Ariel University and Schneider Children's Hospital, Petah Tikva, Israel.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Sansonetti', 'Affiliation': 'Unité de Pathogénie Microbienne Moléculaire, Institut Pasteur, INSERM U1202, Paris, France.'}, {'ForeName': 'Laurence A', 'Initials': 'LA', 'LastName': 'Mulard', 'Affiliation': 'Unité de Chimie des Biomolécules, Institut Pasteur, UMR3523, CNRS, Paris, France.'}, {'ForeName': 'Armelle', 'Initials': 'A', 'LastName': 'Phalipon', 'Affiliation': 'Unité de Pathogénie Microbienne Moléculaire, Institut Pasteur, INSERM U1202, Paris, France.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30488-6'] 1049,33188713,Pattern of progression in advanced hepatocellular carcinoma treated with ramucirumab.,"BACKGROUND & AIMS Radiological progression patterns to first-line sorafenib have been associated with post-progression and overall survival in advanced hepatocellular carcinoma, but these associations remain unknown for therapies in second- and later-line settings. This post hoc analysis of REACH and REACH-2 examined outcomes by radiological progression patterns in the second-line setting of patients with advanced hepatocellular carcinoma treated with ramucirumab or placebo. METHODS Patients with advanced hepatocellular carcinoma, Child-Pugh A and Eastern Cooperative Oncology Group Performance Status 0 or 1 with prior sorafenib were randomized to receive ramucirumab 8mg/kg or placebo every 2 weeks. Among 625 patients with ≥1 progression pattern (new extrahepatic lesion [including new macrovascular invasion], new intrahepatic lesion, extrahepatic growth or intrahepatic growth), data were analysed by trial and for pooled individual patient data for REACH-2 and REACH (alpha-fetoprotein ≥400 ng/mL). Cox models evaluated prognostic implications of progression patterns on overall and post-progression survival. RESULTS Post-progression survival was worse among those with new extrahepatic lesions in REACH (HR 2.33, 95% CI 1.51-3.60), REACH-2 (HR 1.49, 95% CI 0.72-3.08) and the pooled population (HR 1.75, 95% CI 1.12-2.74) compared to other progression patterns. Overall survival was also significantly reduced in those with new extrahepatic lesions across studies. Ramucirumab provided an overall survival benefit across progression patterns, including patients with new extrahepatic lesions (HR 0.56, 95% CI 0.39-0.80) in the pooled population. CONCLUSIONS The emergence of new extrahepatic lesions in the second-line setting is a poor prognostic factor for post-progression survival. The benefit of ramucirumab for overall survival was consistent across progression patterns.",2021,"RESULTS Post-progression survival was worse among those with new extrahepatic lesions in REACH (HR 2.33, 95%CI 1.51-3.60), REACH-2 (HR 1.49, 95%CI 0.72-3.08), and the pooled population (HR 1.75, 95%CI 1.12-2.74) compared to other progression patterns.","['Patients with advanced hepatocellular carcinoma, Child-Pugh A, and Eastern Cooperative Oncology Group performance status 0 or 1 with prior sorafenib', 'patients with advanced hepatocellular carcinoma treated with', 'advanced hepatocellular carcinoma treated with', '625 patients with ≥1 progression pattern (new extrahepatic lesion [including new macrovascular invasion', 'advanced hepatocellular carcinoma']","['Ramucirumab', 'ramucirumab or placebo', 'ramucirumab', 'ramucirumab 8mg/kg or placebo']","['Overall survival', 'overall survival benefit', 'progression survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C4050412', 'cui_str': 'Child-Pugh score'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4517838', 'cui_str': '625'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}]","[{'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",625.0,0.148507,"RESULTS Post-progression survival was worse among those with new extrahepatic lesions in REACH (HR 2.33, 95%CI 1.51-3.60), REACH-2 (HR 1.49, 95%CI 0.72-3.08), and the pooled population (HR 1.75, 95%CI 1.12-2.74) compared to other progression patterns.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Reig', 'Affiliation': 'Barcelona Clinic Liver Cancer Group, Liver Unit, Hospital Clínic of Barcelona. IDIBAPS. CIBERehd. University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Galle', 'Affiliation': 'Department of Internal Medicine, Mainz University Medical Center, Mainz, Germany.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': 'Departments of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Finn', 'Affiliation': 'Division of Hematology/Oncology, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Llovet', 'Affiliation': 'Mount Sinai Liver Cancer Program, Division of Liver Diseases, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Metti', 'Affiliation': 'Syneos Health, Pittsburgh, PA, USA.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Schelman', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Liang', 'Affiliation': 'Eli Lilly and Company, Branchburg, NJ, USA.'}, {'ForeName': 'Chunxiao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Ryan C', 'Initials': 'RC', 'LastName': 'Widau', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Abada', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Andrew X', 'Initials': 'AX', 'LastName': 'Zhu', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, USA.'}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.14731'] 1050,33212239,The Impact of Patient Self-Monitoring Via Electronic Medication Monitor and Mobile App Plus Remote Clinician Feedback on Adherence to Inhaled Corticosteroids: A Randomized Controlled Trial.,"BACKGROUND Poor adherence to inhaled corticosteroids (ICSs) and overuse of short-acting beta 2 -agonists (SABAs) are associated with increased asthma morbidity. OBJECTIVE To assess whether patient self-monitoring via electronic medication monitoring and smartphone application plus remote clinician feedback influences ICS and SABA use. METHODS Adults with uncontrolled asthma and prescribed ICS and SABA were enrolled in this 14-week study. Inhalers were fitted with electronic medication monitoring to track real-time usage. After a 14-day baseline, participants were randomly assigned to the treatment group where they received reminders and feedback on ICS and SABA use via a smartphone application and clinician phone calls, or control group without feedback. Linear mixed models compared the baseline percentage of SABA-free days and ICS adherence to the last 14 study days. RESULTS Participants (n = 100) had a mean age of 48.5 years, 80% were female, 68% white, and 80% privately insured. The percentage of SABA-free days increased significantly in the treatment group (19%; 95% CI, 12 to 26; P < .01) and nonsignificantly in the control group (6%, 95% CI, -3 to 16; P = .18), representing a 13% (95% CI, 1-26; P = .04) difference. ICS adherence changed minimally in the treatment group (-2%; 95% CI, -7 to 3; P = .40), but decreased significantly (-17%; 95% CI, -26 to -8; P < .01) in the control group, representing a 15% (95% CI, 4 to 25; P < .01) difference. CONCLUSIONS Patient self-monitoring via a digital platform plus remote clinician feedback maintained high baseline ICS adherence and decreased SABA use.",2021,"ICS adherence changed minimally in the treatment group (-2%, 95% CI: -7, 3; P = 0.40), but decreased significantly (-17%, 95% CI: -26, -8; P < 0.01) in the control group, representing a 15% (95% CI: 4, 25; P < 0.01) difference. ","['Adults with uncontrolled asthma and prescribed ICS and SABA were enrolled in this 14-week study', 'Participants (n=100) had a mean age of 48.5 years, 80% were female, 68% Caucasian and 80% privately insured']","['corticosteroids', 'patient self-monitoring via electronic medication monitor and mobile app plus remote clinician feedback', 'reminders and feedback on ICS and SABA use via a smartphone application and clinician phone calls, or control group without feedback', 'patient self-monitoring via electronic medication monitoring (EMM) and smartphone application plus remote clinician feedback', 'inhaled corticosteroids (ICS']","['percent of SABA-free days', 'ICS adherence']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0047120', 'cui_str': 'serotonin azidobenzamidine'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0047120', 'cui_str': 'serotonin azidobenzamidine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085421', 'cui_str': 'Medication monitoring'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0047120', 'cui_str': 'serotonin azidobenzamidine'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.251684,"ICS adherence changed minimally in the treatment group (-2%, 95% CI: -7, 3; P = 0.40), but decreased significantly (-17%, 95% CI: -26, -8; P < 0.01) in the control group, representing a 15% (95% CI: 4, 25; P < 0.01) difference. ","[{'ForeName': 'Giselle S', 'Initials': 'GS', 'LastName': 'Mosnaim', 'Affiliation': 'Division of Pulmonary, Allergy and Critical Care, Department of Medicine, NorthShore University HealthSystem, Evanston, Ill. Electronic address: Gmosnaim@northshore.org.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Stempel', 'Affiliation': 'Propeller Health, an Affiliate of ResMed, San Francisco, Calif.'}, {'ForeName': 'Candy', 'Initials': 'C', 'LastName': 'Gonzalez', 'Affiliation': 'Research Institute, NorthShore University HealthSystem, Evanston, Ill.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Adams', 'Affiliation': 'Research Institute, NorthShore University HealthSystem, Evanston, Ill.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'BenIsrael-Olive', 'Affiliation': 'Division of Pulmonary, Allergy and Critical Care, Department of Medicine, NorthShore University HealthSystem, Evanston, Ill.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Gondalia', 'Affiliation': 'ResMed, San Francisco, Calif.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Kaye', 'Affiliation': 'ResMed, San Francisco, Calif.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Shalowitz', 'Affiliation': 'Research Institute, NorthShore University HealthSystem, Evanston, Ill.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Szefler', 'Affiliation': ""Department of Pediatrics, Section of Allergy and Immunology and Pulmonary and Sleep Medicine, University of Colorado School of Medicine and the Breathing Institute, Children's Hospital Colorado, Aurora, Colo.""}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.10.064'] 1051,33213284,Impaired postprandial glucose and no improvement in other cardiometabolic responses or cognitive function by breaking up sitting with bodyweight resistance exercises: a randomised crossover trial.,"The effects of breaking up sitting with resistance exercise on cardiometabolic health and cognitive function in young healthy adults are unknown. This study evaluated the acute effects of breaking up sitting with bodyweight resistance exercise on postprandial glucose, lipids, blood pressure and cognitive function. A randomised crossover design was used. Twelve normal-weight participants aged 25 ± 6 years took part in two, 5 h conditions: (1) uninterrupted sitting (SIT), and (2) sitting with 3 min of bodyweight resistance exercise breaks every 30 min (REX). Dietary intake was standardised across conditions. Linear mixed models were used to compare outcomes between conditions. Postprandial glucose was significantly higher in the REX condition than in SIT (incremental area under the curve 346.3 [95% confidence interval: 233.9, 458.7] and 256.9 [144.4, 369.3] mmol/L∙5 h, respectively, p = 0.045). Blood pressure, lipids and cognitive function outcomes were not different between conditions (p ≥ 0.05). This study suggests that breaking up sitting with bodyweight resistance exercise does not benefit cardiometabolic health or cognitive function acutely in young healthy adults. The longer-term effects of breaking up sitting with resistance exercise warrants investigation to appropriately inform public health guidelines.",2021,"Postprandial glucose was significantly higher in the REX condition than in SIT (incremental area under the curve 346.3 [95% confidence interval: 233.9, 458.7] and 256.9 [144.4, 369.3] mmol/L∙5 h, respectively, p = 0.045).","['young healthy adults', 'Twelve normal-weight participants aged 25\xa0±\xa06\xa0years took part in two, 5\xa0h conditions: (1']","['breaking up sitting with resistance exercise', 'breaking up sitting with bodyweight resistance exercise', 'uninterrupted sitting (SIT), and (2) sitting with 3\xa0min of bodyweight resistance exercise breaks every 30\xa0min (REX']","['Postprandial glucose', 'postprandial glucose, lipids, blood pressure and cognitive function', 'cardiometabolic health and cognitive function', 'Blood pressure, lipids and cognitive function outcomes', 'cardiometabolic responses or cognitive function', 'Impaired postprandial glucose']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0456693', 'cui_str': '/30 min'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",,0.0336419,"Postprandial glucose was significantly higher in the REX condition than in SIT (incremental area under the curve 346.3 [95% confidence interval: 233.9, 458.7] and 256.9 [144.4, 369.3] mmol/L∙5 h, respectively, p = 0.045).","[{'ForeName': 'Opie P', 'Initials': 'OP', 'LastName': 'Charlett', 'Affiliation': 'Institute for Sport and Physical Activity Research, School of Sport Science and Physical Activity, University of Bedfordshire, Bedford, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Morari', 'Affiliation': 'Institute for Sport and Physical Activity Research, School of Sport Science and Physical Activity, University of Bedfordshire, Bedford, UK.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Bailey', 'Affiliation': 'Institute for Sport and Physical Activity Research, School of Sport Science and Physical Activity, University of Bedfordshire, Bedford, UK.'}]",Journal of sports sciences,['10.1080/02640414.2020.1847478'] 1052,33185838,The Influence of Weight-Related Self-Esteem and Symptoms of Depression on Shape and Weight Concerns and Weight-Loss 12 Months After Bariatric Surgery.,"INTRODUCTION While body image can improve following bariatric surgery, a portion of patients continue to experience concerns about weight and shape regardless of weight lost. Research is needed to identify risk factors for post-surgical weight and shape concerns given that body dissatisfaction may contribute to poor outcomes. AIMS To evaluate whether (1) change in weight-related self-esteem and symptoms of depression from pre- to 12-month post-surgery were associated with change in weight and shape concerns independent of weight-loss; (2) improvement in weight and shape concerns, symptoms of depression, and/or weight-related self-esteem predict greater weight-loss 12 months after bariatric surgery; and (3) improvements in weight-related self-esteem, symptoms of depression, weight concerns, or shape concerns predict weight loss. METHODS Fifty adults approved to receive bariatric surgery self-reported body mass index and completed validated measures of weight-related self-esteem, symptoms of depression, and weight and shape concerns pre- and 12-month post-surgery. RESULTS Improvements were observed for weight-related self-esteem, concerns over shape and weight, symptoms of depression, and body mass index from pre- to 12-month post-surgery. Improvement in weight-related self-esteem was associated with concomitant improvements in concerns over shape and weight, independent of weight loss. Improvement in symptoms of depression was associated with improvement in concerns over weight, but not shape. Finally, exploratory analyses indicated that improvements in weight-related self-esteem, and concerns over shape and weight, but not symptoms of depression were associated with improvement in weight-loss. CONCLUSIONS Weight-related self-esteem may represent an overlooked and important target throughout the bariatric surgery process that could enhance surgical outcomes.",2021,"RESULTS Improvements were observed for weight-related self-esteem, concerns over shape and weight, symptoms of depression, and body mass index from pre- to 12-month post-surgery.","['Fifty adults approved to receive bariatric surgery self-reported body mass index and completed validated measures of weight-related self-esteem, symptoms of depression, and weight and shape concerns pre- and 12-month post-surgery']",[],"['weight and shape concerns independent of weight-loss; (2) improvement in weight and shape concerns, symptoms of depression, and/or weight-related self-esteem predict greater weight-loss', 'weight loss', 'weight-related self-esteem, concerns over shape and weight, symptoms of depression, and body mass index', 'weight-related self-esteem', 'weight-related self-esteem, and concerns over shape and weight', 'weight-related self-esteem, symptoms of depression, weight concerns, or shape concerns predict weight loss', 'weight-related self-esteem and symptoms of depression', 'weight-loss', 'Weight-Related Self-Esteem and Symptoms of Depression on Shape and Weight Concerns and Weight-Loss 12\xa0Months']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",[],"[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0332291', 'cui_str': 'Independent of'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",50.0,0.0245208,"RESULTS Improvements were observed for weight-related self-esteem, concerns over shape and weight, symptoms of depression, and body mass index from pre- to 12-month post-surgery.","[{'ForeName': 'Ashley N', 'Initials': 'AN', 'LastName': 'Felske', 'Affiliation': 'Department of Psychology, University of Calgary, 2500 University Drive Dr., NW, Calgary, AB, T2N 1N4, Canada.'}, {'ForeName': 'Tamara M', 'Initials': 'TM', 'LastName': 'Williamson', 'Affiliation': 'Department of Psychology, University of Calgary, 2500 University Drive Dr., NW, Calgary, AB, T2N 1N4, Canada.'}, {'ForeName': 'Samantha R M', 'Initials': 'SRM', 'LastName': 'Scurrey', 'Affiliation': ""Department of Psychology, Memorial University of Newfoundland, 230 Elizabeth Ave, St. John's, NL, A1B 3X9, Canada.""}, {'ForeName': 'Jo Ann', 'Initials': 'JA', 'LastName': 'Telfer', 'Affiliation': 'Calgary Adult Bariatric Surgery Clinic, Alberta Health Services, Richmond Road Diagnostic and Treatment Centre, 1820 Richmond Road, SW, Calgary, AB, T2T 5C7, Canada.'}, {'ForeName': 'Tavis S', 'Initials': 'TS', 'LastName': 'Campbell', 'Affiliation': 'Department of Psychology, University of Calgary, 2500 University Drive Dr., NW, Calgary, AB, T2N 1N4, Canada.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Rash', 'Affiliation': ""Department of Psychology, Memorial University of Newfoundland, 230 Elizabeth Ave, St. John's, NL, A1B 3X9, Canada. jarash@mun.ca.""}]",Obesity surgery,['10.1007/s11695-020-05097-9'] 1053,33183883,Gut microbiota associations with diet in irritable bowel syndrome and the effect of low FODMAP diet and probiotics.,"BACKGROUND AND AIMS Diet is both a modulator of the gastrointestinal microbiota and an important therapy in irritable bowel syndrome (IBS). We aimed to comprehensively (i) identify diet-microbiota associations in adults with IBS consuming habitual diet; (ii) assess the impact of two nutritional interventions on the microbiota; and (iii) determine whether baseline microbiota can predict clinical response to diet or probiotic intervention. METHODS Data were analyzed from 95 individuals with IBS participating in a previously published 4-week 2x2 factorial design randomized controlled trial investigating the impact of the low FODMAP diet (LFD) and co-administration of a probiotic. Diet was assessed at four hierarchical levels and partial 16S rRNA gene sequencing was used to profile the microbiota. RESULTS There were numerous diet-microbiota associations especially at the nutrient level, including a negative association between protein and Bifidobacterium abundance (r s  = -0.358, p < 0.001). After correction for multiple testing, the significance for this association (q = 0.237) and all others was lost. Low FODMAP diet led to changes in abundance of major saccharolytic genera compared with sham diet, including higher Bacteroides (LFD 34.1% (15.7%) vs sham 23.3% (15.2%), q = 0.01) and lower Bifidobacterium (0.9% (1.0%) vs 2.1%, (2.5%) q = 0.029). Compared with placebo, probiotic supplementation led to higher Lactobacillus (probiotic 0.08% (0.1%) vs placebo 0.03% (0.2%), q < 0.001), and Streptococcus abundance (2.0% (2.2%) vs 0.6% (1.2%), q = 0.001). The probiotic treatment buffered the impact of the low FODMAP diet on Bifidobacterium. Baseline microbiota did not predict clinical response to either intervention. CONCLUSIONS Although diet modifies the gut microbiota, bivariate correlation analysis may only provide a limited explanation of the complex diet interactions with individual gut bacteria in IBS. Some diet interventions modify the microbiota in IBS. TRIAL REGISTRY ISRCTN (http://www.isrctn.com) Registered under ISRCTN registry identifier no.ISRCTN02275221.",2021,"Compared with placebo, probiotic supplementation led to higher Lactobacillus (probiotic 0.08% (0.1%) vs placebo 0.03% (0.2%), q < 0.001), and Streptococcus abundance (2.0% (2.2%) vs 0.6% (1.2%), q = 0.001).","['irritable bowel syndrome (IBS', 'adults with IBS consuming habitual diet', 'Data were analyzed from 95 individuals with IBS participating']","['low FODMAP diet and probiotics', 'Low FODMAP diet', 'low FODMAP diet (LFD) and co-administration of a probiotic', 'placebo, probiotic supplementation', 'low FODMAP diet']","['abundance of major saccharolytic genera', 'Streptococcus abundance', 'lower Bifidobacterium']","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C4728066', 'cui_str': 'Low FODMAP diet'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}]",95.0,0.0386556,"Compared with placebo, probiotic supplementation led to higher Lactobacillus (probiotic 0.08% (0.1%) vs placebo 0.03% (0.2%), q < 0.001), and Streptococcus abundance (2.0% (2.2%) vs 0.6% (1.2%), q = 0.001).","[{'ForeName': 'Heidi M', 'Initials': 'HM', 'LastName': 'Staudacher', 'Affiliation': ""King's College London, Department of Nutritional Sciences, London, United Kingdom.""}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Scholz', 'Affiliation': 'Research and Innovation Centre, Department of Food Quality and Nutrition, Nutrition and Nutrigenomics Group, Fondazione Edmund Mach, Trento, Italy.'}, {'ForeName': 'Miranda Ce', 'Initials': 'MC', 'LastName': 'Lomer', 'Affiliation': ""King's College London, Department of Nutritional Sciences, London, United Kingdom; Guy's and St Thomas' NHS Foundation Trust, Department of Gastroenterology, London, UK.""}, {'ForeName': 'Frances S', 'Initials': 'FS', 'LastName': 'Ralph', 'Affiliation': ""King's College London, Department of Nutritional Sciences, London, United Kingdom.""}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Irving', 'Affiliation': ""King's College London, Department of Nutritional Sciences, London, United Kingdom; Guy's and St Thomas' NHS Foundation Trust, Department of Gastroenterology, London, UK.""}, {'ForeName': 'James O', 'Initials': 'JO', 'LastName': 'Lindsay', 'Affiliation': 'Barts Health NHS Trust, Department of Gastroenterology, Royal London Hospital, London, UK; Queen Mary University of London, Centre for Immunobiology, London, UK.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Fava', 'Affiliation': 'Research and Innovation Centre, Department of Food Quality and Nutrition, Nutrition and Nutrigenomics Group, Fondazione Edmund Mach, Trento, Italy.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Tuohy', 'Affiliation': 'Research and Innovation Centre, Department of Food Quality and Nutrition, Nutrition and Nutrigenomics Group, Fondazione Edmund Mach, Trento, Italy.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Whelan', 'Affiliation': ""King's College London, Department of Nutritional Sciences, London, United Kingdom. Electronic address: kevin.whelan@kcl.ac.uk.""}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.10.013'] 1054,33186765,Clinical Outcomes in People with Difficult-to-Control Asthma Using Electronic Monitoring to Support Medication Adherence.,"BACKGROUND Nonadherence in difficult-to-control asthma can be identified using 7-day FeNO suppression testing where patients take additional fluticasone via Diskus with an Inhaler Compliance Assessment (INCA) acoustic monitoring device attached, and self-measure FeNO at home. However, this is inconvenient for patients attending a tertiary center and limited by FeNO meter availability. It is not known if this approach alters clinical outcomes. OBJECTIVES To examine patient acceptability and the effectiveness of replacing usual combination inhaled corticosteroid (ICS)/long-acting β 2 -agonist (LABA) therapy with a fluticasone/salmeterol Diskus 500+INCA for 28 days as the initial intervention, compared with the 7-day FeNO suppression test, and to explore clinical outcomes after INCA monitoring. METHODS A service evaluation of FeNO suppression testing was undertaken in clinical practice. RESULTS Twenty-one of 23 subjects offered replacement of their usual ICS/LABA with fluticasone/salmeterol+INCA as the initial intervention accepted and completed 28 days of monitoring. Fourteen (66.6%) patients reduced their FeNO by >42% (FeNO suppressors), accompanied by improvements in forced expiratory volume in 1 second, Asthma Control Questionnaire, and blood eosinophils, similar to the 7-day test (n = 74). Twenty-two of 62 (35.5%) FeNO suppressors progressed to biological therapy, compared with 24 of 33 (72.7%) nonsuppressors (P = .0006). FeNO suppressors taking maintenance prednisolone (n = 13) who did not receive biological therapy reduced the median baseline dose from 10 to 3 mg, with further reductions limited by adrenal suppression. CONCLUSION Replacing existing inhaled therapy with fluticasone/salmeterol+INCA for 28 days is acceptable to the majority of people with difficult-to-control asthma and identifies prior medication nonadherence. INCA monitoring coupled with clinical support potentially improves patient adherence and asthma control, preventing unnecessary progression to biological therapy.",2021,"FeNO suppressors progressed to biologic therapy, compared to 24/33 (72.7%) non suppressors (p=0.0006).","['patients attending a tertiary centre and limited by FeNO meter availability', 'people with difficult-to-control asthma using electronic monitoring to support medication adherence']","['fluticasone/salmeterol+INCA', 'FeNO suppressors taking maintenance prednisolone', 'biological therapy', 'replacing usual combination inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) therapy with a fluticasone/salmeterol Diskus 500+INCA', 'INCA']","['FEV1, ACQ and blood eosinophils', 'patient adherence and asthma control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0336646', 'cui_str': 'Electronic monitor'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]","[{'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0005527', 'cui_str': 'Biotherapy'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0939232', 'cui_str': 'salmeterol and fluticasone'}, {'cui': 'C0337871', 'cui_str': 'Inca'}]","[{'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0418105,"FeNO suppressors progressed to biologic therapy, compared to 24/33 (72.7%) non suppressors (p=0.0006).","[{'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Boddy', 'Affiliation': 'Department of Respiratory Medicine, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester, United Kingdom.'}, {'ForeName': 'Shamsa', 'Initials': 'S', 'LastName': 'Naveed', 'Affiliation': 'Department of Respiratory Medicine, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester, United Kingdom; Department of Respiratory Sciences, Institute for Lung Health, University of Leicester, Glenfield Hospital, Leicester, United Kingdom.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Craner', 'Affiliation': 'Department of Respiratory Medicine, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester, United Kingdom.'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Murphy', 'Affiliation': 'Department of Respiratory Medicine, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester, United Kingdom.'}, {'ForeName': 'Salman', 'Initials': 'S', 'LastName': 'Siddiqui', 'Affiliation': 'Department of Respiratory Medicine, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester, United Kingdom; Department of Respiratory Sciences, Institute for Lung Health, University of Leicester, Glenfield Hospital, Leicester, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bradding', 'Affiliation': 'Department of Respiratory Medicine, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester, United Kingdom; Department of Respiratory Sciences, Institute for Lung Health, University of Leicester, Glenfield Hospital, Leicester, United Kingdom. Electronic address: pb46@le.ac.uk.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.10.059'] 1055,33189179,Use of effective contraception following provision of the progestogen-only pill for women presenting to community pharmacies for emergency contraception (Bridge-It): a pragmatic cluster-randomised crossover trial.,"BACKGROUND Unless women start effective contraception after oral emergency contraception, they remain at risk of unintended pregnancy. Most women in the UK obtain emergency contraception from community pharmacies. We hypothesised that pharmacist provision of the progestogen-only pill as a bridging interim method of contraception with emergency contraception plus an invitation to a sexual and reproductive health clinic, in which all methods of contraception are available, would result in increased subsequent use of effective contraception. METHODS We did a pragmatic cluster-randomised crossover trial in 29 UK pharmacies among women receiving levonorgestrel emergency contraception. Women aged 16 years or older, not already using hormonal contraception, not on medication that could interfere with the progestogen-only pill, and willing to give contact details for follow-up were invited to participate. In the intervention group, women received a 3-month supply of the progestogen-only pill (75 μg desogestrel) plus a rapid access card to a participating sexual and reproductive health clinic. In the control group, pharmacists advised women to attend their usual contraceptive provider. The order in which each pharmacy provided the intervention or control was randomly assigned using a computer software algorithm. The primary outcome was the use of effective contraception (hormonal or intrauterine) at 4 months. This study is registered, ISRCTN70616901 (complete). FINDINGS Between Dec 19, 2017, and June 26, 2019, 636 women were recruited to the intervention group (316 [49·6%], mean age 22·7 years [SD 5·7]) or the control group (320 [50·3%], 22·6 years [5·1]). Three women (one in the intervention group and two in the control group) were excluded after randomisation. 4-month follow-up data were available for 406 (64%) participants, 25 were lost to follow-up, and two participants no longer wanted to participate in the study. The proportion of women using effective contraception was 20·1% greater (95% CI 5·2-35·0) in the intervention group (mean 58·4%, 48·6-68·2), than in the control group (mean 40·5%, 29·7-51·3 [adjusted for recruitment period, treatment group, and centre]; p=0·011).The difference remained significant after adjusting for age, current sexual relationship, and history of effective contraception use, and was robust to the effect of missing data (assuming missingness at random). No serious adverse events occurred. INTERPRETATION Provision of a supply of the progestogen-only pill with emergency contraception from a community pharmacist, along with an invitation to a sexual and reproductive health clinic, results in a clinically meaningful increase in subsequent use of effective contraception. Widely implemented, this practice could prevent unintended pregnancies after use of emergency contraception. FUNDING National Institute for Health Research (Health Technology Assessment Programme project 15/113/01).",2020,"No serious adverse events occurred. ","['29 UK pharmacies among women receiving levonorgestrel emergency contraception', 'Women aged 16 years or older, not already using hormonal contraception, not on medication that could interfere with the progestogen-only pill, and willing to give contact details for follow-up were invited to participate', 'women presenting to community pharmacies for emergency contraception (Bridge-It', 'Most women in the UK obtain emergency contraception from community pharmacies', 'Between Dec 19, 2017, and June 26, 2019', '636 women were recruited to the intervention group (316 [49·6%], mean age 22·7 years [SD 5·7]) or the control group (320 [50·3%], 22·6 years [5·1']","['progestogen-only pill with emergency contraception', '3-month supply of the progestogen-only pill (75 μg desogestrel) plus a rapid access card to a participating sexual and reproductive health clinic', 'progestogen-only pill']","['use of effective contraception (hormonal or intrauterine', 'proportion of women using effective contraception']","[{'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0558252', 'cui_str': 'Emergency contraception'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C2985296', 'cui_str': 'Hormonal contraception'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0420857', 'cui_str': 'Progestogen only oral contraceptive'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517711', 'cui_str': '320'}]","[{'cui': 'C0420857', 'cui_str': 'Progestogen only oral contraceptive'}, {'cui': 'C0558252', 'cui_str': 'Emergency contraception'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0057558', 'cui_str': 'Desogestrel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",636.0,0.116296,"No serious adverse events occurred. ","[{'ForeName': 'Sharon T', 'Initials': 'ST', 'LastName': 'Cameron', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Edinburgh, Edinburgh, UK; Chalmers Sexual and Reproductive Health, NHS Lothian, Edinburgh, UK. Electronic address: sharon.cameron@ed.ac.uk.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Glasier', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'McDaid', 'Affiliation': 'Institute for Social Science Research, The University of Queensland, Brisbane, QLD, Australia; MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Radley', 'Affiliation': 'Directorate of Public Health, NHS Tayside, Dundee, UK; Division of Cardiovascular Medicines and Diabetes, Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Baraitser', 'Affiliation': ""Department of Sexual Health, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Stephenson', 'Affiliation': ""Elizabeth Garrett Anderson Institute for Women's Health, University College London, London, UK.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gilson', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Battison', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Cowle', 'Affiliation': 'Boots UK, Edinburgh, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Forrest', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Goulao', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Johnstone', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Morelli', 'Affiliation': ""Department of Sexual Health, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Patterson', 'Affiliation': 'MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'McDonald', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Thenmalar', 'Initials': 'T', 'LastName': 'Vadiveloo', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31785-2'] 1056,33191450,Nab-paclitaxel plus S-1 versus nab-paclitaxel plus gemcitabine as first-line chemotherapy in patients with advanced pancreatic ductal adenocarcinoma: a randomized study.,"PURPOSE To investigate the efficacy and safety of nab-paclitaxel plus S-1 (nab-P/S) versus nab-paclitaxel plus gemcitabine (nab-P/G) as first-line chemotherapy in patients with advanced pancreatic ductal adenocarcinoma (PDAC). METHODS Treatment-naïve patients with advanced PDAC were equally randomized to receive nab-P/S or nab-P/G. The primary endpoint was the objective response rate (ORR). The secondary endpoints were ORR of the primary lesion, disease control rate, progression-free survival (PFS), overall survival (OS) and safety. The trial was registered at https://clinicaltrials.gov as NCT03636308. RESULTS A total of 110 patients were planned for enrollment, but the trial was prematurely closed because no better ORR was observed with nab-P/S among the first 40 patients assigned between 08/2018 and 06/2019. The ORR was numerically higher with nab-P/S versus nab-P/G (35.0% vs 25.0%, P = 0.49). The ORRs of the primary lesion for both arms were similar (30.0% and 25.0%, P = 0.72). Disease control rate was 70.0% in each arm. There was no significant difference in PFS and OS between the two arms (median PFS, 6.3 vs 5.7 months, P = 0.34; median OS, 10.2 vs 10.2 months, P = 0.92). Risks of hematological toxicity, liver injury and rash were significantly decreased in the nab-P/S arm. CONCLUSIONS A biweekly combination of nab-P/S yielded comparable efficacy with nab-P/G but improved safety profile. It may be a promising and convenient alternative as first-line and neoadjuvant settings for advanced PDAC.",2021,A biweekly combination of nab-P/S yielded comparable efficacy with nab-P/G but improved safety profile.,"['Treatment-naïve patients with advanced PDAC', '110 patients', 'patients with advanced pancreatic ductal adenocarcinoma', 'patients with advanced pancreatic ductal adenocarcinoma (PDAC']","['nab-P/S or nab-P/G', 'nab-paclitaxel plus S-1 (nab-P/S) versus nab-paclitaxel plus gemcitabine (nab-P/G', 'Nab-paclitaxel plus S-1 versus nab-paclitaxel plus gemcitabine']","['objective response rate (ORR', 'ORR of the primary lesion, disease control rate, progression-free survival (PFS), overall survival (OS) and safety', 'efficacy and safety', 'ORR', 'Disease control rate', 'safety profile', 'PFS and OS', 'ORRs of the primary lesion', 'Risks of hematological toxicity, liver injury and rash']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C4517536', 'cui_str': '110'}]","[{'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0160390', 'cui_str': 'Injury of liver'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}]",110.0,0.166564,A biweekly combination of nab-P/S yielded comparable efficacy with nab-P/G but improved safety profile.,"[{'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zong', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Fucheng Road 52, Haidian District, Beijing, 100142, China.'}, {'ForeName': 'Jiajia', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Fucheng Road 52, Haidian District, Beijing, 100142, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Peng', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Fucheng Road 52, Haidian District, Beijing, 100142, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Lu', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Fucheng Road 52, Haidian District, Beijing, 100142, China.'}, {'ForeName': 'Xicheng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Fucheng Road 52, Haidian District, Beijing, 100142, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Fucheng Road 52, Haidian District, Beijing, 100142, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Fucheng Road 52, Haidian District, Beijing, 100142, China. 13366152815@126.com.'}]",Journal of cancer research and clinical oncology,['10.1007/s00432-020-03442-0'] 1057,33200309,LSG vs MGB-OAGB: 5-Year Follow-up Data and Comparative Outcome of the Two Procedures over Long Term-Results of a Randomised Control Trial.,"BACKGROUND Bariatric surgery is a durable and effective way for the management of obesity and resolution of related comorbidities. The aim of this study is to evaluate the outcome of laparoscopic sleeve gastrectomy (LSG) and one-anastomosis gastric bypass (OAGB) over long term in a South Asian population. MATERIALS AND METHODS This is a prospective randomised trial comparing the outcome of 100 and 101 LSG and OAGB patients respectively after 5-year follow-up. This study is in continuity with previous published papers with 1- and 3-year follow-up. 71 LSG and 73 OAGB patients followed at 5 years. The results of these patients were analysed and compared in terms of %EWL, comorbidity resolution and quality of life (QoL) at 5 years. Bariatric analysis reporting and outcome system (BAROS) was used to assess the outcome of patients. RESULTS At 5-year follow-up, both LSG and OAGB patients performed well and patients had significant improvement in BMI (kg/m 2) . The mean preoperative BMI of LSG and OAGB patients was 44.89 ± 7.94 and 45.32 ± 8.24, and their mean BMI at 5 years was 33.41 ± 6.02, 30.80 ± 3.40 respectively. At 5 years, %EWL was 55.95 ± 27.01 and 65.28 ± 13.98 for LSG and OAGB patients respectively. The QoL score of LSG and OAGB patients was 1.86 ± 0.56 and 2.35 ± 0.41 while comorbidity score was 1.84 ± 0.68 and 2.24 ± 0.62 respectively at 5 years. CONCLUSIONS Both LSG and OAGB are effective bariatric procedures over long term with respect to weight loss, comorbidity resolution and improvement in QoL. OAGB is significantly better than LSG in all the three parameters at 5 years.",2021,"Both LSG and OAGB are effective bariatric procedures over long term with respect to weight loss, comorbidity resolution and improvement in QoL. OAGB is significantly better than LSG in all the three parameters at 5 years.","['a South Asian population', '100 and 101 LSG and OAGB patients respectively after 5-year follow-up']",['laparoscopic sleeve gastrectomy (LSG) and one-anastomosis gastric bypass (OAGB'],"['BMI', 'weight loss, comorbidity resolution and improvement in QoL. OAGB', 'QoL score', 'mean preoperative BMI', 'comorbidity resolution and quality of life (QoL', 'Bariatric analysis reporting and outcome system (BAROS']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",,0.0360337,"Both LSG and OAGB are effective bariatric procedures over long term with respect to weight loss, comorbidity resolution and improvement in QoL. OAGB is significantly better than LSG in all the three parameters at 5 years.","[{'ForeName': 'Mayank', 'Initials': 'M', 'LastName': 'Jain', 'Affiliation': 'Department of Minimal Access & Bariatric Surgery, Synergy Plus Hospital, NH2, Near Guru Ka Taal, Agra, Uttar Pradesh, 282007, India.'}, {'ForeName': 'Om', 'Initials': 'O', 'LastName': 'Tantia', 'Affiliation': 'Department of Minimal Access & Bariatric Surgery ILS Hospitals, DD-6, Sector 1, Salt Lake City, Kolkata, West Bengal, 700064, India. omtantia@gmail.com.'}, {'ForeName': 'Ghanshyam', 'Initials': 'G', 'LastName': 'Goyal', 'Affiliation': 'Department of Minimal Access & Bariatric Surgery ILS Hospitals, DD-6, Sector 1, Salt Lake City, Kolkata, West Bengal, 700064, India.'}, {'ForeName': 'Tamonas', 'Initials': 'T', 'LastName': 'Chaudhuri', 'Affiliation': 'Department of Minimal Access & Bariatric Surgery ILS Hospitals, DD-6, Sector 1, Salt Lake City, Kolkata, West Bengal, 700064, India.'}, {'ForeName': 'Shashi', 'Initials': 'S', 'LastName': 'Khanna', 'Affiliation': 'Department of Minimal Access & Bariatric Surgery ILS Hospitals, DD-6, Sector 1, Salt Lake City, Kolkata, West Bengal, 700064, India.'}, {'ForeName': 'Anshuman', 'Initials': 'A', 'LastName': 'Poddar', 'Affiliation': 'Department of Minimal Access & Bariatric Surgery ILS Hospitals, DD-6, Sector 1, Salt Lake City, Kolkata, West Bengal, 700064, India.'}, {'ForeName': 'Kajari', 'Initials': 'K', 'LastName': 'Majumdar', 'Affiliation': 'Department of Minimal Access & Bariatric Surgery ILS Hospitals, DD-6, Sector 1, Salt Lake City, Kolkata, West Bengal, 700064, India.'}, {'ForeName': 'Sonam', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Department of Minimal Access & Bariatric Surgery ILS Hospitals, DD-6, Sector 1, Salt Lake City, Kolkata, West Bengal, 700064, India.'}]",Obesity surgery,['10.1007/s11695-020-05119-6'] 1058,33201154,"Neoprene Knee Sleeves of Varying Tightness Augment Barbell Squat One Repetition Maximum Performance Without Improving Other Indices of Muscular Strength, Power, or Endurance.","ABSTRACT Machek, SB, Cardaci, TD, Wilburn, DT, Cholewinski, MC, Latt, SL, Harris, DR, and Willoughby, DS. Neoprene knee sleeves of varying tightness augment barbell squat one repetition maximum performance without improving other indices of muscular strength, power, or endurance. J Strength Cond Res 35(2S): S6-S15, 2021-Neoprene knee sleeves are commonly used by powerlifters and recreational users but are heavily under-researched. Furthermore, no data exist on whether knee sleeves of varying compressive tightness impact muscular performance similar to commonly used knee wraps, which are both generally effective and more so when increasingly constrictive. Fifteen resistance trained, knee sleeve naive, recreational weight lifting men (22.1 ± 4.1 years; 177.5 ± 5.9 cm; 87.8 ± 7.8 kg) visited the laboratory on 3 separate occasions one week apart, assigned in a randomized, crossover, and counterbalanced fashion to either a minimally supportive control sleeve (CS) condition, a manufacturer-recommended sizing neoprene knee sleeve (""normal"" sleeve; NS), or a one size smaller (than NS) neoprene knee sleeve (tighter sleeve [TS]). On each visit, subjects sequentially completed vertical jump (countermovement and squat jumps for both peak and mean power), one repetition maximum (1RM) barbell squat, and GymAware assessments (peak power, peak velocity, and dip) at 90% (reported) and 100% (tested) 1RM as well as one-leg extension (1RM, repetitions to failure, and total volume load at 75% 1RM) tests. All data were analyzed using one-way repeated measures analysis of variance at p < 0.05. Analysis revealed a significant condition effect on barbell squat 1RM (p = 0.003; η2 = 0.339), whereby both NS (p = 0.044; 166 ± 24 kg) and TS (p = 0.019; 166 ± 21 kg) outperformed CS (161 ± 22 kg), with no difference between neoprene sleeves. Conversely, no other tested parameters differed between knee sleeve conditions (p ≥ 0.05). The present results demonstrate that neoprene knee sleeves may function independent of tightness, relative to recommended sizing and ultimately unlike knee wraps. Furthermore, the singular benefits observed on barbell squat maximal strength potentially suggests an exercise-specific benefit yet to be fully elucidated.",2021,"Analysis revealed a significant condition effect on barbell squat 1RM (p = 0.003; η = 0.339), whereby both NS (p = 0.044; 166 ± 24 kg) and TS (p = 0.019; 166 ± 21 kg) outperformed CS (161 ± 22 kg), with no difference between neoprene sleeves.","['Fifteen resistance trained, knee sleeve naive, recreational weightlifting men (22.1 ± 4.1 years; 177.5 ± 5.9 cm; 87.8 ± 7.8 kg) visited the laboratory on 3 separate occasions one week apart']","['J Strength Cond Res XX(X', 'Varying Tightness Augment Barbell Squat One Repetition Maximum Performance', 'minimally supportive control sleeve (CS) condition, a manufacturer-recommended sizing neoprene knee sleeve (""normal"" sleeve; NS), or a one size smaller (than NS) neoprene knee sleeve (tighter sleeve [TS']","['Machek, SB, Cardaci, TD, Wilburn, DT, Cholewinski, MC, Latt, SL, Harris, DR, and Willoughby, DS', 'Muscular Strength, Power, or Endurance', 'repetition maximum (1RM) barbell squat, and GymAware assessments (peak power, peak velocity, and dip', 'barbell squat 1RM', 'muscular strength, power, or endurance']","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0183336', 'cui_str': 'Sleeve'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C1442452', 'cui_str': 'One week'}]","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0183336', 'cui_str': 'Sleeve'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0027673', 'cui_str': 'Neoprene'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}]","[{'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0037390', 'cui_str': 'Snuff tobacco'}]",15.0,0.0488826,"Analysis revealed a significant condition effect on barbell squat 1RM (p = 0.003; η = 0.339), whereby both NS (p = 0.044; 166 ± 24 kg) and TS (p = 0.019; 166 ± 21 kg) outperformed CS (161 ± 22 kg), with no difference between neoprene sleeves.","[{'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Machek', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Baylor University, Waco, Texas.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Cardaci', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Baylor University, Waco, Texas.'}, {'ForeName': 'Dylan T', 'Initials': 'DT', 'LastName': 'Wilburn', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Baylor University, Waco, Texas.'}, {'ForeName': 'Mitchell C', 'Initials': 'MC', 'LastName': 'Cholewinski', 'Affiliation': 'Department of Health, Human Performance, and Recreation, Baylor University, Waco, Texas.'}, {'ForeName': 'Scarlett Lin', 'Initials': 'SL', 'LastName': 'Latt', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Baylor University, Waco, Texas.'}, {'ForeName': 'Dillon R', 'Initials': 'DR', 'LastName': 'Harris', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Baylor University, Waco, Texas.'}, {'ForeName': 'Darryn S', 'Initials': 'DS', 'LastName': 'Willoughby', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Baylor University, Waco, Texas.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003869'] 1059,33201347,Serum 4β-hydroxycholesterol increases during fluconazole treatment.,"PURPOSE The antifungal drugs ketoconazole and itraconazole reduce serum concentrations of 4β-hydroxycholesterol, which is a validated marker for hepatic cytochrome P450 (CYP) 3A4 activity. We tested the effect of another antifungal triazole agent, fluconazole, on serum concentrations of different sterols and oxysterols within the cholesterol metabolism to see if this inhibitory reaction is a general side effect of azole antifungal agents. METHODS In a prospective, double-blind, placebo-controlled, two-way crossover design, we studied 17 healthy subjects (nine men, eight women) who received 400 mg fluconazole or placebo daily for 8 days. On day 1 before treatment and on day 8 after the last dose, fasting blood samples were collected. Serum cholesterol precursors and oxysterols were measured by gas chromatography-mass spectrometry-selected ion monitoring and expressed as the ratio to cholesterol (R_sterol). RESULTS Under fluconazole treatment, serum R_lanosterol and R_24,25-dihydrolanosterol increased significantly without affecting serum cholesterol or metabolic downstream markers of hepatic cholesterol synthesis. Serum R_4β-, R_24S-, and R_27-hydroxycholesterol increased significantly. CONCLUSION Fluconazole inhibits the 14α-demethylation of lanosterol and 24,25-dihydrolanosterol, regulated by CYP51A1, without reduction of total cholesterol synthesis. The increased serum level of R_4β-hydroxycholesterol under fluconazole treatment is in contrast to the reductions observed under ketoconazole and itraconazole treatments. The question, whether this increase is caused by induction of CYP3A4 or by inhibition of the catabolism of 4β-hydroxycholesterol, must be answered by mechanistic in vitro and in vivo studies comparing effects of various azole antifungal agents on hepatic CYP3A4 activity.",2021,"Fluconazole inhibits the 14α-demethylation of lanosterol and 24,25-dihydrolanosterol, regulated by CYP51A1, without reduction of total cholesterol synthesis.","['17 healthy subjects (nine men, eight women) who received 400\xa0mg', 'daily for 8\xa0days']","['itraconazole', 'ketoconazole and itraconazole', 'ketoconazole', 'fluconazole treatment', 'Fluconazole', 'fluconazole or placebo', 'placebo', 'fluconazole']","['Serum cholesterol precursors and oxysterols', 'total cholesterol synthesis', 'serum cholesterol or metabolic downstream markers of hepatic cholesterol synthesis', 'serum level of R_4β-hydroxycholesterol', 'serum R_lanosterol and R_24,25-dihydrolanosterol', 'Serum R_4β-, R_24S-, and R_27-hydroxycholesterol increased significantly', 'Serum 4β-hydroxycholesterol']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0022625', 'cui_str': 'Ketoconazole'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0587184', 'cui_str': 'Serum cholesterol measurement'}, {'cui': 'C4277571', 'cui_str': 'Oxysterol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0522506', 'cui_str': 'Downstream'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020339', 'cui_str': 'Hydroxycholesterols'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",17.0,0.0428714,"Fluconazole inhibits the 14α-demethylation of lanosterol and 24,25-dihydrolanosterol, regulated by CYP51A1, without reduction of total cholesterol synthesis.","[{'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Lütjohann', 'Affiliation': 'Institute of Clinical Chemistry and Clinical Pharmacology, University Hospital Bonn, Venusberg-Campus 1, 53127, Bonn, Germany. dieter.luetjohann@ukbonn.de.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Stellaard', 'Affiliation': 'Institute of Clinical Chemistry and Clinical Pharmacology, University Hospital Bonn, Venusberg-Campus 1, 53127, Bonn, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Kerksiek', 'Affiliation': 'Institute of Clinical Chemistry and Clinical Pharmacology, University Hospital Bonn, Venusberg-Campus 1, 53127, Bonn, Germany.'}, {'ForeName': 'Jörn', 'Initials': 'J', 'LastName': 'Lötsch', 'Affiliation': 'Institute of Clinical Pharmacology, Goethe-University Frankfurt, Theodor Stern Kai 7, 60590, Frankfurt, Germany.'}, {'ForeName': 'Bruno G', 'Initials': 'BG', 'LastName': 'Oertel', 'Affiliation': 'Institute of Clinical Pharmacology, Goethe-University Frankfurt, Theodor Stern Kai 7, 60590, Frankfurt, Germany.'}]",European journal of clinical pharmacology,['10.1007/s00228-020-03041-5'] 1060,33196302,Using contact-based education to destigmatize opioid use disorder among medical students.,"CONTEXT All first- and second-year (i.e., pre-clinical) medical students at a large, Midwestern medical school with three campuses were invited to participate in a two-arm, parallel educational study comparing the efficacy of two types of curricular interventions. Students at the main campus attended the modified contact-based education panel or the didactic lecture in person, while students at the two distance campuses attended the modified contact-based education or lecture remotely using the University's videoconferencing system. Impact: A total of 109 students participated in the study (average age 24.2 years ( SD  = 2.6), 64.2% female, 79.8% white, 56.0% second-year students, 67.9% attended on main campus, lecture = 52 participants, modified contact-based = 57 participants). Baseline responses were similar across groups. Following the session, participants in both interventions rated drug abuse (percent increase = 21.2%, p < .001) and prescription drug diversion (percent increase = 7.6%, p = .004) as more serious problems. Participants from both interventions expressed increased confidence in caring for patients with OUD (percent increase = 45.5%, p < .001) and increased interest in pursuing MAT training (percent increase = 21.5%, p = .04). Both curricular interventions were equally effective at reducing OUD stigma with a significant 8.2% decrease in total stigma scores and a large effect size ( p < .001, η p 2 = .34). Lastly, participants with lower post-assessment OUD stigma scores were more likely to indicate that they would pursue additional training to provide MAT ( p = .02). Lessons learned: Exposure to opioid-specific education with a focus on MAT and recovery, regardless of education type, positively affected opioid-related postgraduate intentions and reduced OUD stigma. Notably, these findings suggest that there are multiple efficacious techniques to reduce OUD stigma during preclinical training.",2021,"Following the session, participants in both interventions rated drug abuse (percent increase = 21.2%, p < .001) and prescription drug diversion (percent increase = 7.6%, ","['i.e., pre-clinical) medical students at a large, Midwestern medical school with three campuses', ""Students at the main campus attended the modified contact-based education panel or the didactic lecture in person, while students at the two distance campuses attended the modified contact-based education or lecture remotely using the University's videoconferencing system"", '109 students participated in the study (average age 24.2\u2009years ( SD \u2009=\u20092.6), 64.2% female, 79.8% white, 56.0% second-year students, 67.9% attended on main campus, lecture = 52 participants, modified contact-based = 57 participants', 'medical students']",[],"['serious problems', 'prescription drug diversion', 'OUD stigma', 'confidence in caring', 'total stigma scores', 'OUD stigma scores', 'interest in pursuing MAT training']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0036378', 'cui_str': 'Medical School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0205436', 'cui_str': 'Second'}]",[],"[{'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C3658253', 'cui_str': 'Controlled Substance Diversion'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0580931', 'cui_str': 'In care'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0066317', 'cui_str': 'methylallyl trisulfide'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",109.0,0.0379617,"Following the session, participants in both interventions rated drug abuse (percent increase = 21.2%, p < .001) and prescription drug diversion (percent increase = 7.6%, ","[{'ForeName': 'Sophia C', 'Initials': 'SC', 'LastName': 'Mort', 'Affiliation': 'Department of Medicine, Ohio University Heritage College of Osteopathic Medicine, Athens, Ohio, USA.'}, {'ForeName': 'Sebastián R', 'Initials': 'SR', 'LastName': 'Díaz', 'Affiliation': ""Dean's Office of Medical Education, Northeast Ohio Medical University College of Medicine, Rootstown, Ohio, USA.""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Beverly', 'Affiliation': 'Department of Primary Care, Ohio University Heritage College of Osteopathic Medicine, Athens, Ohio, USA.'}]",Teaching and learning in medicine,['10.1080/10401334.2020.1820869'] 1061,33196605,Exogenous Ketosis Impairs 30-min Time-Trial Performance Independent of Bicarbonate Supplementation.,"PURPOSE We recently demonstrated that coingestion of NaHCO3 to counteract ketoacidosis resulting from oral ketone ester (KE) intake improves mean power output during a 15-min time trial (TT) at the end of a 3-h cycling race by ~5%. This ergogenic effect occurred at a time when blood ketone levels were low, as ketosis was only induced during the initial ~2 h of the race. Therefore, in the current study, we investigated whether performance also increases if blood ketone levels are increased in the absence of ketoacidosis during high-intensity exercise. METHODS In a double-blind crossover design, 14 well-trained male cyclists completed a 30-min TT (TT30') followed by an all-out sprint at 175% of lactate threshold (SPRINT). Subjects were randomized to receive (i) 50 g KE, (ii) 180 mg·kg-1 body weight NaHCO3 (BIC), (iii) KE + BIC, or (iv) a control drink (CON). RESULTS KE ingestion increased blood d-ß-hydroxybutyrate to ~3-4 mM during the TT30' and SPRINT (P < 0.001 vs CON). In KE, blood pH and bicarbonate concomitantly dropped, causing 0.05 units lower pH and 2.6 mM lower bicarbonate in KE compared with CON during the TT30' and SPRINT (P < 0.001 vs CON). BIC coingestion resulted in 0.9 mM higher blood d-ß-hydroxybutyrate (P < 0.001 vs KE) and completely counteracted ketoacidosis during exercise (P > 0.05 vs CON). Mean power output during TT30' was similar between CON and BIC at 281 W, but was 1.5% lower in the KE conditions (main effect of KE: P = 0.03). Time to exhaustion in the SPRINT was ~64 s in CON and KE and increased by ~8% in the BIC conditions (main effect of BIC: P < 0.01). DISCUSSION Neutralization of acid-base disturbance by BIC coingestion is insufficient to counteract the slightly negative effect of KE intake during high-intensity exercise.",2021,BIC co-ingestion resulted in 0.9 mM higher blood D-ß-hydroxybutyrate (p<0.001 vs. KE) and completely counteracted ketoacidosis during exercise (p>0.05 vs. CON).,"['fourteen well-trained male cyclists', '50']","['oral ketone ester (KE) intake', 'g ketone ester (KE), ii) 180 mg⋅kg body weight NaHCO3 (BIC), iii', 'Bicarbonate Supplementation', 'control drink (CON']","['Mean power output during TT30', 'Time-to-exhaustion in SPRINT', 'blood ketone levels', 'blood pH and bicarbonate', 'blood D-ß-hydroxybutyrate']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0014898', 'cui_str': 'Ester'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C1271768', 'cui_str': 'Blood ketone level'}, {'cui': 'C0853363', 'cui_str': 'Blood pH'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}]",,0.161,BIC co-ingestion resulted in 0.9 mM higher blood D-ß-hydroxybutyrate (p<0.001 vs. KE) and completely counteracted ketoacidosis during exercise (p>0.05 vs. CON).,"[{'ForeName': 'Chiel', 'Initials': 'C', 'LastName': 'Poffé', 'Affiliation': 'Exercise Physiology Research Group, Department of Movement Sciences, KU Leuven, Leuven, BELGIUM.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Wyns', 'Affiliation': 'Bakala Academy-Athletic Performance Center, KU Leuven, Leuven, BELGIUM.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Ramaekers', 'Affiliation': 'Exercise Physiology Research Group, Department of Movement Sciences, KU Leuven, Leuven, BELGIUM.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hespel', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002552'] 1062,33198432,Intraoperative aerosol box use: does an educational visual aid reduce contamination?,"BACKGROUND The aerosol box was rapidly developed and disseminated to minimize viral exposure during aerosolizing procedures during the COVID-19 pandemic, yet users may not understand how to use and clean the device. This could potentially lead to increased viral exposure to subsequent patients and practitioners. We evaluated intraoperative contamination and aerosol box decontamination and the impact of a preoperative educational visual aid. METHODS Using a double-blinded randomized design, forty-four anesthesiology trainees and faculty completed a simulated anesthetic case using an aerosol box contaminated with a fluorescent marker; half of the subjects received a visual aid prior to the simulation. Intraoperative contamination was evaluated at 10 standardized locations using an ultraviolet (UV) light. Next, subjects were instructed to clean the aerosol box for use on the next patient. Following cleaning, the box was evaluated for decontamination using an UV light. RESULTS Median total contamination score was significantly reduced in the experimental group (5.0 vs. 10.0, P < 0.001). The aerosol box was completely cleaned by 36.4% of subjects in the experimental group compared to 4.5% in the control group (P = 0.009). CONCLUSIONS The use of a visual aid significantly decreased intraoperative contamination and improved box cleaning. Despite these findings, a potentially clinically significant amount of viral exposure may exist. Thorough evaluation of the risks and benefits of the aerosol box should be completed prior to use. If an aerosol box is used, a visual aid should be considered to remind practitioners how to best use and clean the box.",2021,"The aerosol box was completely cleaned by 36.4% of subjects in the experimental group compared to 4.5% in the control group (p = .009). ",[],[],"['intraoperative contamination and improved box cleaning', 'Intraoperative contamination', 'Median total contamination score']",[],[],"[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0355304,"The aerosol box was completely cleaned by 36.4% of subjects in the experimental group compared to 4.5% in the control group (p = .009). ","[{'ForeName': 'Garrett W', 'Initials': 'GW', 'LastName': 'Burnett', 'Affiliation': 'Department of Anesthesiology, Perioperative & Pain Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, Perioperative & Pain Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Fried', 'Affiliation': 'Department of Anesthesiology, Perioperative & Pain Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Ronak S', 'Initials': 'RS', 'LastName': 'Shah', 'Affiliation': 'Department of Anesthesiology, Perioperative & Pain Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology, Perioperative & Pain Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Katz', 'Affiliation': 'Department of Anesthesiology, Perioperative & Pain Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}]",Korean journal of anesthesiology,['10.4097/kja.20511'] 1063,33205991,Effectiveness of Adding a Mask Recommendation to Other Public Health Measures to Prevent SARS-CoV-2 Infection in Danish Mask Wearers : A Randomized Controlled Trial.,"BACKGROUND Observational evidence suggests that mask wearing mitigates transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is uncertain if this observed association arises through protection of uninfected wearers (protective effect), via reduced transmission from infected mask wearers (source control), or both. OBJECTIVE To assess whether recommending surgical mask use outside the home reduces wearers' risk for SARS-CoV-2 infection in a setting where masks were uncommon and not among recommended public health measures. DESIGN Randomized controlled trial (DANMASK-19 [Danish Study to Assess Face Masks for the Protection Against COVID-19 Infection]). (ClinicalTrials.gov: NCT04337541). SETTING Denmark, April and May 2020. PARTICIPANTS Adults spending more than 3 hours per day outside the home without occupational mask use. INTERVENTION Encouragement to follow social distancing measures for coronavirus disease 2019, plus either no mask recommendation or a recommendation to wear a mask when outside the home among other persons together with a supply of 50 surgical masks and instructions for proper use. MEASUREMENTS The primary outcome was SARS-CoV-2 infection in the mask wearer at 1 month by antibody testing, polymerase chain reaction (PCR), or hospital diagnosis. The secondary outcome was PCR positivity for other respiratory viruses. RESULTS A total of 3030 participants were randomly assigned to the recommendation to wear masks, and 2994 were assigned to control; 4862 completed the study. Infection with SARS-CoV-2 occurred in 42 participants recommended masks (1.8%) and 53 control participants (2.1%). The between-group difference was -0.3 percentage point (95% CI, -1.2 to 0.4 percentage point; P  = 0.38) (odds ratio, 0.82 [CI, 0.54 to 1.23]; P  = 0.33). Multiple imputation accounting for loss to follow-up yielded similar results. Although the difference observed was not statistically significant, the 95% CIs are compatible with a 46% reduction to a 23% increase in infection. LIMITATION Inconclusive results, missing data, variable adherence, patient-reported findings on home tests, no blinding, and no assessment of whether masks could decrease disease transmission from mask wearers to others. CONCLUSION The recommendation to wear surgical masks to supplement other public health measures did not reduce the SARS-CoV-2 infection rate among wearers by more than 50% in a community with modest infection rates, some degree of social distancing, and uncommon general mask use. The data were compatible with lesser degrees of self-protection. PRIMARY FUNDING SOURCE The Salling Foundations.",2021,"The recommendation to wear surgical masks to supplement other public health measures did not reduce the SARS-CoV-2 infection rate among wearers by more than 50% in a community with modest infection rates, some degree of social distancing, and uncommon general mask use.","['3030 participants were randomly assigned to the recommendation to wear masks, and 2994 were assigned to control; 4862 completed the study', 'Denmark, April and May 2020', 'Adults spending more than 3 hours per day outside the home without occupational mask use', 'Danish Mask Wearers ']","['Encouragement to follow social distancing measures for coronavirus disease 2019, plus either no mask recommendation or a recommendation to wear a mask when outside the home among other persons together with a supply of 50 surgical masks and instructions for proper use']","['SARS-CoV-2 infection in the mask wearer at 1 month by antibody testing, polymerase chain reaction (PCR), or hospital diagnosis', 'PCR positivity', 'infection', 'SARS-CoV-2 infection rate']","[{'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0556974', 'cui_str': 'hours/day'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}]","[{'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0181758', 'cui_str': 'Surgical face mask'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580327', 'cui_str': 'Antibody studies'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",3030.0,0.130204,"The recommendation to wear surgical masks to supplement other public health measures did not reduce the SARS-CoV-2 infection rate among wearers by more than 50% in a community with modest infection rates, some degree of social distancing, and uncommon general mask use.","[{'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Bundgaard', 'Affiliation': 'The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark (H.B., J.S.B., D.E.T., M.M.P., C.R.V., U.C.W., A.R.).'}, {'ForeName': 'Johan Skov', 'Initials': 'JS', 'LastName': 'Bundgaard', 'Affiliation': 'The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark (H.B., J.S.B., D.E.T., M.M.P., C.R.V., U.C.W., A.R.).'}, {'ForeName': 'Daniel Emil Tadeusz', 'Initials': 'DET', 'LastName': 'Raaschou-Pedersen', 'Affiliation': 'The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark (H.B., J.S.B., D.E.T., M.M.P., C.R.V., U.C.W., A.R.).'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'von Buchwald', 'Affiliation': 'Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark (C.V., T.T., H.U.).'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Todsen', 'Affiliation': 'Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark (C.V., T.T., H.U.).'}, {'ForeName': 'Jakob Boesgaard', 'Initials': 'JB', 'LastName': 'Norsk', 'Affiliation': 'Herlev & Gentofte Hospital, Copenhagen University Hospital, Herlev, Denmark (J.B.N., P.B.N., K.F., R.H., J.H.K., K.I.).'}, {'ForeName': 'Mia M', 'Initials': 'MM', 'LastName': 'Pries-Heje', 'Affiliation': 'The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark (H.B., J.S.B., D.E.T., M.M.P., C.R.V., U.C.W., A.R.).'}, {'ForeName': 'Christoffer Rasmus', 'Initials': 'CR', 'LastName': 'Vissing', 'Affiliation': 'The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark (H.B., J.S.B., D.E.T., M.M.P., C.R.V., U.C.W., A.R.).'}, {'ForeName': 'Pernille B', 'Initials': 'PB', 'LastName': 'Nielsen', 'Affiliation': 'Herlev & Gentofte Hospital, Copenhagen University Hospital, Herlev, Denmark (J.B.N., P.B.N., K.F., R.H., J.H.K., K.I.).'}, {'ForeName': 'Ulrik C', 'Initials': 'UC', 'LastName': 'Winsløw', 'Affiliation': 'The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark (H.B., J.S.B., D.E.T., M.M.P., C.R.V., U.C.W., A.R.).'}, {'ForeName': 'Kamille', 'Initials': 'K', 'LastName': 'Fogh', 'Affiliation': 'Herlev & Gentofte Hospital, Copenhagen University Hospital, Herlev, Denmark (J.B.N., P.B.N., K.F., R.H., J.H.K., K.I.).'}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Hasselbalch', 'Affiliation': 'Herlev & Gentofte Hospital, Copenhagen University Hospital, Herlev, Denmark (J.B.N., P.B.N., K.F., R.H., J.H.K., K.I.).'}, {'ForeName': 'Jonas H', 'Initials': 'JH', 'LastName': 'Kristensen', 'Affiliation': 'Herlev & Gentofte Hospital, Copenhagen University Hospital, Herlev, Denmark (J.B.N., P.B.N., K.F., R.H., J.H.K., K.I.).'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ringgaard', 'Affiliation': 'The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark (H.B., J.S.B., D.E.T., M.M.P., C.R.V., U.C.W., A.R.).'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Porsborg Andersen', 'Affiliation': 'Nordsjaellands Hospital, Hillerød, and Aalborg University Hospital, Aalborg, Denmark (M.P.A., C.T.).'}, {'ForeName': 'Nicole Bakkegård', 'Initials': 'NB', 'LastName': 'Goecke', 'Affiliation': 'Centre for Diagnostics, Technical University of Denmark, Kongens Lyngby, Denmark (N.B.G.).'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Trebbien', 'Affiliation': 'National Influenza Center, Statens Serum Institut, Copenhagen, Denmark (R.T.).'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Skovgaard', 'Affiliation': 'Technical University of Denmark, Kongens Lyngby, Denmark (K.S.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Benfield', 'Affiliation': 'Center of Research & Disruption of Infectious Diseases, Amager and Hvidovre Hospital, Copenhagen University Hospital, Hvidovre, Denmark (T.B.).'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Ullum', 'Affiliation': 'Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark (C.V., T.T., H.U.).'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Torp-Pedersen', 'Affiliation': 'Nordsjaellands Hospital, Hillerød, and Aalborg University Hospital, Aalborg, Denmark (M.P.A., C.T.).'}, {'ForeName': 'Kasper', 'Initials': 'K', 'LastName': 'Iversen', 'Affiliation': 'Herlev & Gentofte Hospital, Copenhagen University Hospital, Herlev, Denmark (J.B.N., P.B.N., K.F., R.H., J.H.K., K.I.).'}]",Annals of internal medicine,['10.7326/M20-6817'] 1064,33210285,A double-blind randomized trial on subendometrial injection of vasopressin to control bleeding in postpartum hysterectomy due to abnormally invasive placenta.,"OBJECTIVE To investigate the effect of subendometrial vasopressin injection in patients with abnormally invasive placenta (AIP), who underwent cesarean section and hysterectomy. METHODS This randomized double-blinded clinical trial was conducted on pregnant women diagnosed with AIP grade 4 and 5 by ultrasonography during cesarean section. Women were randomly divided into two equal groups including group 1 (vasopressin) and group 2 (control) who underwent 20 units of vasopressin and 20 cc normal saline injection, respectively. Vasopressin and placebo were injected subendometrially 1 cm medial to the uterine vessels into the lower uterine segment. The exclusion criteria include presence of myocardial infarction, cardiomyopathy, congestive heart failure, uncontrolled hypertension, chronic obstructive pulmonary disease, pelvic malignancy. The outcome of the study was total quantitative blood loss during the cesarean section. We estimated blood loss by measuring the blood volume in one of the suction bottles with addition for weight changes of mops, pads, and soaked linen savers. RESULTS Sixty patients were recruited into the study, 30 as the vasopressin group and 30 as the controls; with no excluded case. The amount of bleeding in the vasopressin group was significantly lower compared with that in the control group (P < 0.001). In the vasopressin group, 83.4% of patients had bleeding of less than 1.5 L, while only 3.3% of the control women had bleeding of less than 1.5 L (relative risk = 5). In addition, the number of injected packed cells was lower in the vasopressin group (P < 0.001). CONCLUSION It was shown that vasopressin injection can help prevent excess hemorrhage and the subsequent risks of anemia or blood transfusions during abdominal hysterectomy in women with AIP.",2021,"In addition, the number of injected packed cells was lower in the vasopressin group (P<0.001). ","['postpartum hysterectomy due to abnormally invasive placenta', 'women with AIP', 'Sixty patients were recruited into the study, 30 as the vasopressin group and 30 as the controls; with no excluded case', 'pregnant women diagnosed with AIP grade 4 and 5 by ultrasonography during cesarean section', 'patients with abnormally invasive placenta (AIP), who underwent cesarean section and hysterectomy']","['Vasopressin and placebo', 'subendometrial vasopressin injection', 'vasopressin', 'subendometrial injection of vasopressin', 'vasopressin injection', 'group 1 (vasopressin) and group 2 (control) who underwent 20 units of vasopressin and 20\xa0cc normal saline injection']","['number of injected packed cells', 'amount of bleeding', 'total quantitative blood loss', 'blood loss', 'bleeding']","[{'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4735297', 'cui_str': 'Vasopressin (USP) Injection'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C2316467', 'cui_str': 'Packed red blood cells'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}]",60.0,0.168748,"In addition, the number of injected packed cells was lower in the vasopressin group (P<0.001). ","[{'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Ghotbizadeh Vhdani', 'Affiliation': 'Maternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Najmeh', 'Initials': 'N', 'LastName': 'Nasiri Khormoji', 'Affiliation': 'Maternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Negar', 'Initials': 'N', 'LastName': 'Eftekhar', 'Affiliation': 'Anesthesia & Pain Department, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Deldar Pasikhani', 'Affiliation': 'Maternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sedigheh', 'Initials': 'S', 'LastName': 'Hantoushzadeh', 'Affiliation': 'Maternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Azin', 'Initials': 'A', 'LastName': 'Ghamari', 'Affiliation': 'Growth and Development Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Panahi', 'Affiliation': 'Maternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13440'] 1065,33211076,Efficacy and Safety of a Proposed Ranibizumab Biosimilar Product vs a Reference Ranibizumab Product for Patients With Neovascular Age-Related Macular Degeneration: A Randomized Clinical Trial.,"Importance Neovascular age-related macular degeneration is the leading cause of blindness in individuals 50 years or older. The availability of a ranibizumab biosimilar product (SB11) may facilitate access to an effective alternative to this treatment. Objective To demonstrate equivalence of efficacy, similar safety, and similar immunogenicity of SB11 compared with the reference ranibizumab. Design, Setting, and Participants This randomized, double-masked, parallel-group phase 3 equivalence study was conducted in 75 centers in 9 countries from March 14, 2018, to December 9, 2019, among 705 participants 50 years or older with neovascular age-related macular degeneration with active subfoveal choroidal neovascularization lesions. Analysis was performed on an intent-to-treat basis. Interventions Intravitreous injection of SB11 or ranibizumab, 0.5 mg, every 4 weeks through week 48. Main Outcomes and Measures Preplanned interim analysis after all participants completed the week 24 assessment of primary efficacy end points at week 8 for change from baseline in best-corrected visual acuity (BCVA) and week 4 for central subfield thickness (CST), with predefined equivalence margins for adjusted treatment differences of -3 letters to 3 letters for BCVA and -36 μm to 36 μm for CST. Results Baseline and disease characteristics among 705 randomized participants (403 women [57.2%]; mean [SD] age, 74.1 [8.5] years) were comparable between treatment groups (SB11, 351; ranibizumab, 354). Least-squares mean (SE) changes in BCVA from baseline at week 8 were 6.2 (0.5) letters in the SB11 group vs 7.0 (0.5) letters in the ranibizumab group, with an adjusted treatment difference of -0.8 letter (90% CI, -1.8 to 0.2 letters). Least-squares mean (SE) changes in CST from baseline at week 4 were -108 (5) μm in the SB11 group vs -100 (5) μm in the ranibizumab group, with an adjusted treatment difference of -8 μm (95% CI, -19 to 3 μm). Incidences of treatment-emergent adverse events (231 of 350 [66.0%] vs 237 of 354 [66.9%]), including serious treatment-emergent adverse events (44 of 350 [12.6%] vs 44 of 354 [12.4%]) and treatment-emergent adverse events leading to study drug discontinuation (8 of 350 [2.3%] vs 5 of 354 [1.4%]), were similar in the SB11 and ranibizumab groups. Immunogenicity was low, with a cumulative incidence of antidrug antibodies up to week 24 of 3.0% (10 of 330) in the SB11 group and 3.1% (10 of 327) in the ranibizumab group. Conclusions and Relevance These findings of equivalent efficacy and similar safety and immunogenicity profiles compared with ranibizumab support the use of SB11 for patients with neovascular age-related macular degeneration. Trial Registration ClinicalTrials.gov Identifier: NCT03150589.",2021,"Incidences of treatment-emergent adverse events (231 of 350 [66.0%] vs 237 of 354 [66.9%]), including serious treatment-emergent adverse events (44 of 350 [12.6%] vs 44 of 354 [12.4%]) and treatment-emergent adverse events leading to study drug discontinuation (8 of 350 [2.3%] vs 5 of 354 [1.4%]), were similar in the SB11 and ranibizumab groups.","['patients with neovascular age-related macular degeneration', 'individuals 50 years or older', '705 randomized participants (403 women [57.2%]; mean [SD] age, 74.1 [8.5] years', '75 centers in 9 countries from March 14, 2018, to December 9, 2019, among 705 participants 50 years or older with neovascular age-related macular degeneration with active subfoveal choroidal neovascularization lesions', 'Patients With Neovascular Age-Related Macular Degeneration']","['SB11 or ranibizumab', 'Ranibizumab Biosimilar Product vs a Reference Ranibizumab Product', 'ranibizumab', 'ranibizumab biosimilar product (SB11', 'SB11']","['serious treatment-emergent adverse events', 'Efficacy and Safety', 'Least-squares mean (SE) changes in BCVA', 'Immunogenicity', 'Incidences of treatment-emergent adverse events', 'best-corrected visual acuity (BCVA) and week 4 for central subfield thickness (CST', 'cumulative incidence of antidrug antibodies']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0442185', 'cui_str': 'Subfoveal'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]",705.0,0.40346,"Incidences of treatment-emergent adverse events (231 of 350 [66.0%] vs 237 of 354 [66.9%]), including serious treatment-emergent adverse events (44 of 350 [12.6%] vs 44 of 354 [12.4%]) and treatment-emergent adverse events leading to study drug discontinuation (8 of 350 [2.3%] vs 5 of 354 [1.4%]), were similar in the SB11 and ranibizumab groups.","[{'ForeName': 'Se Joon', 'Initials': 'SJ', 'LastName': 'Woo', 'Affiliation': 'Department of Ophthalmology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.'}, {'ForeName': 'Miroslav', 'Initials': 'M', 'LastName': 'Veith', 'Affiliation': 'Department of Ophthalmology, Third Faculty of Medicine, Charles University in Prague, Prague, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hamouz', 'Affiliation': 'Department of Ophthalmology, Third Faculty of Medicine, Charles University in Prague, Prague, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Ernest', 'Affiliation': 'Department of Ophthalmology, Central Military Hospital, Prague, Czech Republic.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Zalewski', 'Affiliation': 'Diagnostic and Microsurgery Center of the Eye LENS, Olsztyn, Poland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Studnicka', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine in Hradec Kralove, Charles University in Prague, Prague, Czech Republic.'}, {'ForeName': 'Attila', 'Initials': 'A', 'LastName': 'Vajas', 'Affiliation': 'Department of Ophthalmology, University of Debrecen, Debrecen, Hungary.'}, {'ForeName': 'Andras', 'Initials': 'A', 'LastName': 'Papp', 'Affiliation': 'Department of Ophthalmology, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Vogt', 'Initials': 'V', 'LastName': 'Gabor', 'Affiliation': 'Department of Ophthalmology, Medical Centre, Hungarian Defence Forces, Budapest, Hungary.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Luu', 'Affiliation': 'Retina Consultants of Southern Colorado, Colorado Springs.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Matuskova', 'Affiliation': 'Department of Ophthalmology, University Hospital Brno, Brno, Czech Republic.'}, {'ForeName': 'Young Hee', 'Initials': 'YH', 'LastName': 'Yoon', 'Affiliation': 'Department of Ophthalmology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Tamás', 'Initials': 'T', 'LastName': 'Pregun', 'Affiliation': 'Department of Ophthalmology, Bajcsy-Zsilinszky Hospital, Budapest, Hungary.'}, {'ForeName': 'Taehyung', 'Initials': 'T', 'LastName': 'Kim', 'Affiliation': 'Medical Team, Samsung Bioepis, Incheon, Korea.'}, {'ForeName': 'Donghoon', 'Initials': 'D', 'LastName': 'Shin', 'Affiliation': 'Medical Team, Samsung Bioepis, Incheon, Korea.'}, {'ForeName': 'Neil M', 'Initials': 'NM', 'LastName': 'Bressler', 'Affiliation': 'Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.5053'] 1066,33221618,Radiation dose reduction capabilities of a new C-arm system with optimized hard- and software.,"PURPOSE To assess the radiation dose reduction capabilities and the image quality of a new C-arm system in comparison to a standard C-arm system. METHOD Prospective, randomized, IRB approved two-arm trial design. 49 consecutive patients with primary or secondary liver cancer were treated with transarterial chemoembolization (TACE) on two different angiography units. 28 patients were treated on a conventional angiography unit B, 21 patients on unit A which provides improved hardware and optimized image processing algorithms. Dose area product (DAP) and fluoroscopy time were recorded. DSA image quality of all procedures was assessed on a four-rank-scale by two independent and blinded readers. RESULTS Both cohorts showed no significant differences with regard to patient characteristics, tumor burden and fluoroscopy time. The new system resulted in a statistically significant reduction of cumulative DAP of 72% compared to the old platform (median 76 vs. 269 Gy*cm2). Individually, Fluoro-DAP and DSA-DAP decreased by 48% and 77% (p = 0.012 and p < 0.01), respectively. No statistically significant differences in DSA image quality were found between the two imaging platforms. CONCLUSIONS The new C-arm system significantly reduced radiation exposure for TACE procedures without increased radiation time or negative impact on DSA image quality. The combination of optimized hardware and software yields the highest radiation dose reduction and is of utmost importance for patients and interventionalists.",2021,The new C-arm system significantly reduced radiation exposure for TACE procedures without increased radiation time or negative impact on DSA image quality.,"['49 consecutive patients with primary or secondary liver cancer', '28 patients']","['conventional angiography unit B, 21 patients on unit A which provides improved hardware and optimized image processing algorithms', 'transarterial chemoembolization (TACE']","['DSA image quality', 'patient characteristics, tumor burden and fluoroscopy time', 'cumulative DAP', 'Dose area product (DAP) and fluoroscopy time', 'Fluoro-DAP and DSA-DAP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}]","[{'cui': 'C0442842', 'cui_str': 'Conventional angiography'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0522522', 'cui_str': 'Transarterial approach'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}]","[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1449699', 'cui_str': 'Tumor Load'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",49.0,0.041164,The new C-arm system significantly reduced radiation exposure for TACE procedures without increased radiation time or negative impact on DSA image quality.,"[{'ForeName': 'Domagoj', 'Initials': 'D', 'LastName': 'Javor', 'Affiliation': 'Division of Cardiovascular and Interventional Radiology, Department of Biomedical Imaging and Image-guided Therapy, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. Electronic address: domagoj.javor@meduniwien.ac.at.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Moyses', 'Affiliation': 'Division of Cardiovascular and Interventional Radiology, Department of Biomedical Imaging and Image-guided Therapy, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Loewe', 'Affiliation': 'Division of Cardiovascular and Interventional Radiology, Department of Biomedical Imaging and Image-guided Therapy, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Ruediger E', 'Initials': 'RE', 'LastName': 'Schernthaner', 'Affiliation': 'Division of Cardiovascular and Interventional Radiology, Department of Biomedical Imaging and Image-guided Therapy, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}]",European journal of radiology,['10.1016/j.ejrad.2020.109367'] 1067,33189747,Limitations of Conventional Magnetic Resonance Imaging as a Predictor of Death or Disability Following Neonatal Hypoxic-Ischemic Encephalopathy in the Late Hypothermia Trial.,"OBJECTIVE To investigate if magnetic resonance imaging (MRI) is an accurate predictor for death or moderate-severe disability at 18-22 months of age among infants with neonatal encephalopathy in a trial of cooling initiated at 6-24 hours. STUDY DESIGN Subgroup analysis of infants ≥36 weeks of gestation with moderate-severe neonatal encephalopathy randomized at 6-24 postnatal hours to hypothermia or usual care in a multicenter trial of late hypothermia. MRI scans were performed per each center's practice and interpreted by 2 central readers using the Eunice Kennedy Shriver National Institute of Child Health and Human Development injury score (6 levels, normal to hemispheric devastation). Neurodevelopmental outcomes were assessed at 18-22 months of age. RESULTS Of 168 enrollees, 128 had an interpretable MRI and were seen in follow-up (n = 119) or died (n = 9). MRI findings were predominantly acute injury and did not differ by cooling treatment. At 18-22 months, death or severe disability occurred in 20.3%. No infant had moderate disability. Agreement between central readers was moderate (weighted kappa 0.56, 95% CI 0.45-0.67). The adjusted odds of death or severe disability increased 3.7-fold (95% CI 1.8-7.9) for each increment of injury score. The area under the curve for severe MRI patterns to predict death or severe disability was 0.77 and the positive and negative predictive values were 36% and 100%, respectively. CONCLUSIONS MRI injury scores were associated with neurodevelopmental outcome at 18-22 months among infants in the Late Hypothermia Trial. However, the results suggest caution when using qualitative interpretations of MRI images to provide prognostic information to families following perinatal hypoxia-ischemia. TRIAL REGISTRATION Clinicaltrials.gov: NCT00614744.",2021,The adjusted odds of death or severe disability increased 3.7-fold (95% confidence interval 1.8-7.9) for each increment of injury score.,"['Sub-group analysis of infants ≥ 36 weeks of gestation with moderate-severe neonatal encephalopathy randomized at 6-24 postnatal hours to hypothermia or usual care in a multicenter trial of late hypothermia', 'death or moderate-severe disability at 18-22 months of age among infants with neonatal encephalopathy in a trial of cooling initiated at 6-24 hours', '168 enrollees']","['Conventional Magnetic Resonance Imaging', 'magnetic resonance imaging (MRI']","['death or severe disability', 'adjusted odds of death or severe disability', 'Neurodevelopmental outcomes', 'MRI injury scores', 'moderate disability', 'Death or Disability']","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0235820', 'cui_str': 'Neonatal encephalopathy'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0206012', 'cui_str': 'Multicentre Trials'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C4319556', 'cui_str': '168'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]",,0.330788,The adjusted odds of death or severe disability increased 3.7-fold (95% confidence interval 1.8-7.9) for each increment of injury score.,"[{'ForeName': 'Abbot R', 'Initials': 'AR', 'LastName': 'Laptook', 'Affiliation': 'Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI. Electronic address: alaptook@wihri.org.'}, {'ForeName': 'Seetha', 'Initials': 'S', 'LastName': 'Shankaran', 'Affiliation': 'Department of Pediatrics, Wayne State University, Detroit, MI.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Barnes', 'Affiliation': 'Department of Radiology and Pediatrics, Stanford University School of Medicine, Palo Alto, CA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Rollins', 'Affiliation': 'Department of Radiology, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Barbara T', 'Initials': 'BT', 'LastName': 'Do', 'Affiliation': 'Biostatistics and Epidemiology Division, RTI International, Research Triangle Park, NC.'}, {'ForeName': 'Nehal A', 'Initials': 'NA', 'LastName': 'Parikh', 'Affiliation': ""Perinatal Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Hamrick', 'Affiliation': ""Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta, GA.""}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Hintz', 'Affiliation': ""Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto, CA.""}, {'ForeName': 'Jon E', 'Initials': 'JE', 'LastName': 'Tyson', 'Affiliation': 'Department of Pediatrics, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'Bell', 'Affiliation': 'Department of Pediatrics, University of Iowa, Iowa City, IA.'}, {'ForeName': 'Namasivayam', 'Initials': 'N', 'LastName': 'Ambalavanan', 'Affiliation': 'Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Ronald N', 'Initials': 'RN', 'LastName': 'Goldberg', 'Affiliation': 'Department of Pediatrics, Duke University, Durham, NC.'}, {'ForeName': 'Athina', 'Initials': 'A', 'LastName': 'Pappas', 'Affiliation': 'Department of Pediatrics, Wayne State University, Detroit, MI.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Huitema', 'Affiliation': 'Social, Statistical and Environmental Sciences Unit, RTI International, Rockville, MD.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pedroza', 'Affiliation': 'Department of Pediatrics, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Aasma S', 'Initials': 'AS', 'LastName': 'Chaudhary', 'Affiliation': 'Department of Pediatrics, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Angelita M', 'Initials': 'AM', 'LastName': 'Hensman', 'Affiliation': 'Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI.'}, {'ForeName': 'Abhik', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Social, Statistical and Environmental Sciences Unit, RTI International, Rockville, MD.'}, {'ForeName': 'Myra', 'Initials': 'M', 'LastName': 'Wyckoff', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': ""Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto, CA.""}, {'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'Walsh', 'Affiliation': ""Department of Pediatrics, Rainbow Babies & Children's Hospital, Case Western Reserve University, Cleveland, OH.""}, {'ForeName': 'Kristi L', 'Initials': 'KL', 'LastName': 'Watterberg', 'Affiliation': 'University of New Mexico Health Sciences Center, Albuquerque, NM.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Faix', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Truog', 'Affiliation': ""Department of Pediatrics, Children's Mercy Hospital and University of Missouri Kansas City School of Medicine, Kansas City, MO.""}, {'ForeName': 'Ronnie', 'Initials': 'R', 'LastName': 'Guillet', 'Affiliation': 'University of Rochester School of Medicine and Dentistry, Rochester, NY.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Sokol', 'Affiliation': 'Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Brenda B', 'Initials': 'BB', 'LastName': 'Poindexter', 'Affiliation': ""Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN; Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.""}, {'ForeName': 'Rosemary D', 'Initials': 'RD', 'LastName': 'Higgins', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, Pregnancy and Perinatology Branch, Bethesda, MD; George Mason University, Fairfax, VA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.11.015'] 1068,33190147,Effect of High-Dose Omega-3 Fatty Acids vs Corn Oil on Major Adverse Cardiovascular Events in Patients at High Cardiovascular Risk: The STRENGTH Randomized Clinical Trial.,"Importance It remains uncertain whether the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) reduce cardiovascular risk. Objective To determine the effects on cardiovascular outcomes of a carboxylic acid formulation of EPA and DHA (omega-3 CA) with documented favorable effects on lipid and inflammatory markers in patients with atherogenic dyslipidemia and high cardiovascular risk. Design, Setting, and Participants A double-blind, randomized, multicenter trial (enrollment October 30, 2014, to June 14, 2017; study termination January 8, 2020; last patient visit May 14, 2020) comparing omega-3 CA with corn oil in statin-treated participants with high cardiovascular risk, hypertriglyceridemia, and low levels of high-density lipoprotein cholesterol (HDL-C). A total of 13 078 patients were randomized at 675 academic and community hospitals in 22 countries in North America, Europe, South America, Asia, Australia, New Zealand, and South Africa. Interventions Participants were randomized to receive 4 g/d of omega-3 CA (n = 6539) or corn oil, which was intended to serve as an inert comparator (n = 6539), in addition to usual background therapies, including statins. Main Outcomes and Measures The primary efficacy measure was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization. Results When 1384 patients had experienced a primary end point event (of a planned 1600 events), the trial was prematurely halted based on an interim analysis that indicated a low probability of clinical benefit of omega-3 CA vs the corn oil comparator. Among the 13 078 treated patients (mean [SD] age, 62.5 [9.0] years; 35% women; 70% with diabetes; median low-density lipoprotein [LDL] cholesterol level, 75.0 mg/dL; median triglycerides level, 240 mg/dL; median HDL-C level, 36 mg/dL; and median high-sensitivity C-reactive protein level, 2.1 mg/L), 12 633 (96.6%) completed the trial with ascertainment of primary end point status. The primary end point occurred in 785 patients (12.0%) treated with omega-3 CA vs 795 (12.2%) treated with corn oil (hazard ratio, 0.99 [95% CI, 0.90-1.09]; P = .84). A greater rate of gastrointestinal adverse events was observed in the omega-3 CA group (24.7%) compared with corn oil-treated patients (14.7%). Conclusions and Relevance Among statin-treated patients at high cardiovascular risk, the addition of omega-3 CA, compared with corn oil, to usual background therapies resulted in no significant difference in a composite outcome of major adverse cardiovascular events. These findings do not support use of this omega-3 fatty acid formulation to reduce major adverse cardiovascular events in high-risk patients. Trial Registration ClinicalTrials.gov Identifier: NCT02104817.",2020,"A greater rate of gastrointestinal adverse events was observed in the omega-3 CA group (24.7%) compared with corn oil-treated patients (14.7%). ","['Patients at High Cardiovascular Risk', 'treated participants with high cardiovascular risk, hypertriglyceridemia, and low levels of high-density lipoprotein cholesterol (HDL-C', 'patients with atherogenic dyslipidemia and high cardiovascular risk', 'Among the 13\u202f078 treated patients (mean [SD] age, 62.5 [9.0] years; 35% women; 70% with diabetes; median low-density lipoprotein [LDL] cholesterol level, 75.0 mg/dL; median triglycerides level, 240 mg/dL; median HDL-C level, 36 mg/dL; and median high-sensitivity C-reactive protein level, 2.1 mg/L), 12\u202f633 (96.6%) completed the trial with ascertainment of primary end point status', 'high-risk patients', 'A total of 13\u202f078 patients were randomized at 675 academic and community hospitals in 22 countries in North America, Europe, South America, Asia, Australia, New Zealand, and South Africa', '1384 patients had experienced a primary end point event (of a planned 1600 events', 'enrollment October 30, 2014, to June 14, 2017; study termination January 8, 2020; last patient visit May 14, 2020) comparing']","['omega-3 CA (n\u2009=\u20096539) or corn oil, which was intended to serve as an inert comparator (n\u2009=\u20096539), in addition to usual background therapies, including statins', 'omega-3 fatty acid formulation', 'carboxylic acid formulation of EPA and DHA (omega-3 CA', 'High-Dose Omega-3 Fatty Acids vs Corn Oil', 'omega-3 CA vs the corn oil comparator', 'omega-3 CA', 'omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA', 'omega-3 CA with corn oil in statin']","['composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization', 'composite outcome of major adverse cardiovascular events', 'rate of gastrointestinal adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C4524040', 'cui_str': 'Atherogenic dyslipidaemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439268', 'cui_str': 'mg/L'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517854', 'cui_str': '675'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0037713', 'cui_str': 'South America'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C4517592', 'cui_str': '1600'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0010029', 'cui_str': 'Corn Oil'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0007066', 'cui_str': 'Carboxylic acid'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",13078.0,0.263921,"A greater rate of gastrointestinal adverse events was observed in the omega-3 CA group (24.7%) compared with corn oil-treated patients (14.7%). ","[{'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Nicholls', 'Affiliation': 'Monash Cardiovascular Research Centre, Victorian Heart Institute, Monash University, Melbourne, Australia.'}, {'ForeName': 'A Michael', 'Initials': 'AM', 'LastName': 'Lincoff', 'Affiliation': 'Cleveland Clinic Coordinating Center for Clinical Research, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Garcia', 'Affiliation': 'Cleveland Clinic Coordinating Center for Clinical Research, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Dianna', 'Initials': 'D', 'LastName': 'Bash', 'Affiliation': 'Cleveland Clinic Coordinating Center for Clinical Research, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Christie M', 'Initials': 'CM', 'LastName': 'Ballantyne', 'Affiliation': 'Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Barter', 'Affiliation': 'University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Davidson', 'Affiliation': 'University of Chicago, Chicago, Illinois.'}, {'ForeName': 'John J P', 'Initials': 'JJP', 'LastName': 'Kastelein', 'Affiliation': 'Academic Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Koenig', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'Division of Cardiology, University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Dariush', 'Initials': 'D', 'LastName': 'Mozaffarian', 'Affiliation': 'Friedman School of Nutrition Science and Policy, Tufts University, Boston, Massachusetts.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': 'Center for Cardiovascular Disease Prevention, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Kausik K', 'Initials': 'KK', 'LastName': 'Ray', 'Affiliation': 'Imperial College of London, London, United Kingdom.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Katona', 'Affiliation': 'AstraZeneca BioPharmaceuticals R&D, Late-stage Development, Cardiovascular, Renal and Metabolic, Gaithersburg, Maryland.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Himmelmann', 'Affiliation': 'AstraZeneca BioPharmaceuticals R&D, Late-stage Development, Cardiovascular, Renal and Metabolic, Gothenburg, Sweden.'}, {'ForeName': 'Larrye E', 'Initials': 'LE', 'LastName': 'Loss', 'Affiliation': 'AstraZeneca BioPharmaceuticals R&D, Late-stage Development, Cardiovascular, Renal and Metabolic, Gaithersburg, Maryland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Rensfeldt', 'Affiliation': 'AstraZeneca BioPharmaceuticals R&D, Late-stage Development, Cardiovascular, Renal and Metabolic, Gothenburg, Sweden.'}, {'ForeName': 'Torbjörn', 'Initials': 'T', 'LastName': 'Lundström', 'Affiliation': 'AstraZeneca BioPharmaceuticals R&D, Late-stage Development, Cardiovascular, Renal and Metabolic, Gothenburg, Sweden.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Agrawal', 'Affiliation': 'AstraZeneca BioPharmaceuticals R&D, Late-stage Development, Cardiovascular, Renal and Metabolic, Gothenburg, Sweden.'}, {'ForeName': 'Venu', 'Initials': 'V', 'LastName': 'Menon', 'Affiliation': 'Cleveland Clinic Coordinating Center for Clinical Research, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Wolski', 'Affiliation': 'Cleveland Clinic Coordinating Center for Clinical Research, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Nissen', 'Affiliation': 'Cleveland Clinic Coordinating Center for Clinical Research, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}]",JAMA,['10.1001/jama.2020.22258'] 1069,33191527,Prior exercise enhances skeletal muscle microvascular blood flow and mitigates microvascular flow impairments induced by a high-glucose mixed meal in healthy young men.,"KEY POINTS Exercise, insulin-infusion and low-glucose mixed-nutrient meal ingestion increases muscle microvascular blood flow which in part facilitates glucose delivery and disposal. In contrast, high-glucose ingestion impairs muscle microvascular blood flow which may contribute to impaired postprandial metabolism. We investigated the effects of prior cycling exercise on postprandial muscle microvascular blood flow responses to a high-glucose mixed-nutrient meal ingested 3 and 24 h post-exercise. Prior exercise enhanced muscle microvascular blood flow and mitigated microvascular impairments induced by a high-glucose mixed meal ingested 3 h post-exercise, and to a lesser extent 24 h post-exercise. High-glucose ingestion 3 h post-exercise leads to greater postprandial blood glucose, non-esterified fatty acids, and fat oxidation, and a delay in the insulin response to the meal compared to control. Effects of acute exercise on muscle microvascular blood flow persist well after the cessation of exercise which may be beneficial for conditions characterized by microvascular and glycaemic dysfunction. ABSTRACT Exercise, insulin-infusion and low-glucose mixed-nutrient meal ingestion lead to increased muscle microvascular blood flow (MBF), whereas high-glucose ingestion impairs MBF. We investigated whether prior cycling exercise could enhance postprandial muscle MBF and prevent MBF impairments induced by high-glucose mixed-nutrient meal ingestion. In a randomized cross-over design, eight healthy young men ingested a high-glucose mixed-nutrient meal (1.1 g glucose/kg body weight; 45% carbohydrate, 20% protein and 35% fat) after an overnight fast (no-exercise control) and 3 h and 24 h after moderate-intensity cycling exercise (1 h at 70-75% V ̇ O 2 peak ). Skeletal muscle MBF, measured directly by contrast-enhanced ultrasound, was lower at 60 min and 120 min postprandially compared to baseline in all conditions (P < 0.05), with a greater decrease occurring from 60 min to 120 min in the control (no-exercise) condition only (P < 0.001). Despite this meal-induced decrease, MBF was still markedly higher compared to control in the 3 h post-exercise condition at 0 min (pre-meal; 74%, P = 0.004), 60 min (112%, P = 0.002) and 120 min (223%, P < 0.001), and in the 24 h post-exercise condition at 120 min postprandially (132%, P < 0.001). We also report that in the 3 h post-exercise condition postprandial blood glucose, non-esterified fatty acids (NEFAs), and fat oxidation were substantially elevated, and the insulin response to the meal delayed compared to control. This probably reflects a combination of increased post-exercise exogenous glucose appearance, substrate competition, and NEFA-induced insulin resistance. We conclude that prior cycling exercise elicits long-lasting effects on muscle MBF and partially mitigates MBF impairments induced by high-glucose mixed-nutrient meal ingestion.",2021,"Skeletal muscle MBF, measured directly by contrast-enhanced ultrasound, was lower at 60 min and 120 min postprandially compared to baseline in all conditions (P ","['eight healthy young men ingested a high-glucose mixed-nutrient meal (1.1\xa0g glucose/kg body weight; 45% carbohydrate, 20% protein and 35% fat) after an', 'healthy young men']","['prior cycling exercise', 'overnight fast (no-exercise control) and 3\xa0h and 24\xa0h after moderate-intensity cycling exercise (1\xa0h at 70-75% V ̇', 'High-glucose ingestion 3\xa0h post-exercise', 'acute exercise']","['postprandial blood glucose, non-esterified fatty acids, and fat oxidation', 'postprandial muscle MBF and prevent MBF impairments', 'muscle microvascular blood flow and mitigated microvascular impairments', 'postprandial muscle microvascular blood flow responses', 'muscle microvascular blood flow', 'muscle microvascular blood flow (MBF', 'exercise condition postprandial blood glucose, non-esterified fatty acids (NEFAs), and fat oxidation', 'Skeletal muscle MBF', 'MBF']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0860803', 'cui_str': 'Glucose increased'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]","[{'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0860803', 'cui_str': 'Glucose increased'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0369212', 'cui_str': 'Esterified fatty acid'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}]",8.0,0.0190199,"Skeletal muscle MBF, measured directly by contrast-enhanced ultrasound, was lower at 60 min and 120 min postprandially compared to baseline in all conditions (P ","[{'ForeName': 'Lewan', 'Initials': 'L', 'LastName': 'Parker', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}, {'ForeName': 'Dale J', 'Initials': 'DJ', 'LastName': 'Morrison', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}, {'ForeName': 'Glenn D', 'Initials': 'GD', 'LastName': 'Wadley', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Shaw', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Betik', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Roberts-Thomson', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}, {'ForeName': 'Gunveen', 'Initials': 'G', 'LastName': 'Kaur', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}, {'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Keske', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}]",The Journal of physiology,['10.1113/JP280651'] 1070,33200413,Smartphone-Delivered Progressive Muscle Relaxation for the Treatment of Migraine in Primary Care: A Randomized Controlled Trial.,"OBJECTIVE Scalable, accessible forms of behavioral therapy for migraine prevention are needed. We assessed the feasibility and acceptability of progressive muscle relaxation (PMR) delivered by a smartphone application (app) in the Primary Care setting. METHODS This pilot study was a non-blinded, randomized, parallel-arm controlled trial of adults with migraine and 4+ headache days/month. Eligible participants spoke English and owned a smartphone. All participants were given the RELAXaHEAD app which includes an electronic headache diary. Participants were randomized to receive 1 of the 2 versions of the app-one with PMR and the other without PMR. The primary outcomes were measures of feasibility (adherence to the intervention and diary entries during the 90-day interval) and acceptability (satisfaction levels). We conducted exploratory analyses to determine whether there was a change in Migraine Disability Assessment Scale (MIDAS) scores or a change in headache days. RESULTS Of 139 participants (77 PMR, 62 control), 116 (83%) were female, mean age was 41.7 ± 12.8 years. Most patients 108/139 (78%) had moderate-severe disability. Using a 1-5 Likert scale, participants found the app easy to use (mean 4.2 ± 0.7) and stated that they would be happy to engage in the PMR intervention again (mean 4.3 ± 0.6). For the first 6 weeks, participants practiced PMR 2-4 days/week. Mean per session duration was 11.1 ± 8.3 minutes. Relative to the diary-only group, the PMR group showed a greater non-significant decline in mean MIDAS scores (-8.7 vs -22.7, P = .100) corresponding to a small-moderate mean effect size (Cohen's d = 0.38). CONCLUSION Smartphone-delivered PMR may be an acceptable, accessible form of therapy for migraine. Mean effects show a small-moderate mean effect size in disability scores.",2020,"Relative to the diary-only group, the PMR group showed a greater non-significant decline in mean MIDAS scores (-8.7 vs -22.7, P = .100) corresponding to a small-moderate mean effect size (Cohen's d = 0.38). ","['Eligible participants spoke English and owned a smartphone', 'adults with migraine and 4+ headache days/month', '139 participants (77 PMR, 62 control), 116 (83%) were female, mean age was 41.7\xa0±\xa012.8 years', 'Migraine in Primary Care']","['RELAXaHEAD', 'Smartphone-Delivered Progressive Muscle Relaxation', 'PMR and the other without PMR', 'progressive muscle relaxation (PMR) delivered by a smartphone application (app']","['disability scores', 'moderate-severe disability', 'feasibility (adherence to the intervention and diary entries during the 90-day interval) and acceptability (satisfaction levels', 'mean MIDAS scores', 'Migraine Disability Assessment Scale (MIDAS) scores']","[{'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0556971', 'cui_str': 'days/month'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517547', 'cui_str': '12.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C3854497', 'cui_str': 'Disability assessment scale'}]",139.0,0.0933415,"Relative to the diary-only group, the PMR group showed a greater non-significant decline in mean MIDAS scores (-8.7 vs -22.7, P = .100) corresponding to a small-moderate mean effect size (Cohen's d = 0.38). ","[{'ForeName': 'Mia T', 'Initials': 'MT', 'LastName': 'Minen', 'Affiliation': 'Department of Neurology, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Samrachana', 'Initials': 'S', 'LastName': 'Adhikari', 'Affiliation': 'Department of Population Health, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Padikkala', 'Affiliation': 'Center for Healthcare Innovation and Delivery Science, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Sumaiya', 'Initials': 'S', 'LastName': 'Tasneem', 'Affiliation': 'Center for Healthcare Innovation and Delivery Science, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Bagheri', 'Affiliation': 'Center for Healthcare Innovation and Delivery Science, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Goldberg', 'Affiliation': 'Department of Medicine Faculty Group Practices, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Powers', 'Affiliation': ""Behavioral Medicine, Headache Medicine, Clinical Psychology, Cincinnati Children's Hospital, Cincinnati, OH, USA.""}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'Montefiore Headache Center, Department of Neurology, Albert Einstein College of Medicine, New York, NY, USA.'}]",Headache,['10.1111/head.14010'] 1071,33200488,"The effects of curcumin intake on wound healing and metabolic status in patients with diabetic foot ulcer: A randomized, double-blind, placebo-controlled trial.","This study was conducted to determine the effects of curcumin intake on wound healing and metabolic status in patients with diabetic foot ulcer (DFU). The current randomized, double-blind, placebo-controlled trial was conducted among 60 patients with grade 3 DFU. Participants were randomly allocated into two groups (30 participants each group), received either 80 mg nanocurcumin daily for 12 weeks or placebo. Primary endpoints in this study were serum insulin levels and insulin resistance. Curcumin intake significantly decreased fasting plasma glucose (p = .02), insulin (p = .01), insulin resistance (p = .02), and significantly increased insulin sensitivity (p = .008) compared with the placebo. Moreover, curcumin intake led to a significant reduction in total- (p < .001), LDL-cholesterol (p < .001), and a significant increase in total antioxidant capacity (TAC) (p < .001) and total glutathione (GSH) (p = .01) compared with the placebo. However, there was no significant improvement in wound healing parameters. Overall, our study demonstrated that nanocurcumin intake in patients with DFU resulted in a significant improvement of glycemic control, total- and LDL-cholesterol, TAC, and GSH but did not affect the indicators of ulcer size.",2021,"Curcumin intake significantly decreased fasting plasma glucose (p = .02), insulin (p = .01), insulin resistance (p = .02), and significantly increased insulin sensitivity (p = .008) compared with the placebo.","['60 patients with grade 3 DFU', 'patients with DFU', 'patients with diabetic foot ulcer (DFU', 'patients with diabetic foot ulcer']","['80\u2009mg nanocurcumin daily for 12\u2009weeks or placebo', 'placebo', 'curcumin intake']","['wound healing parameters', 'serum insulin levels and insulin resistance', 'total antioxidant capacity (TAC', 'wound healing and metabolic status', 'total glutathione (GSH', 'LDL-cholesterol', 'insulin resistance', 'fasting plasma glucose', 'glycemic control, total- and LDL-cholesterol, TAC, and GSH', 'insulin sensitivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}]",60.0,0.355009,"Curcumin intake significantly decreased fasting plasma glucose (p = .02), insulin (p = .01), insulin resistance (p = .02), and significantly increased insulin sensitivity (p = .008) compared with the placebo.","[{'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Mokhtari', 'Affiliation': 'Department of Infectious Diseases, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Razzaghi', 'Affiliation': 'Department of Infectious Diseases, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Mansooreh', 'Initials': 'M', 'LastName': 'Momen-Heravi', 'Affiliation': 'Department of Infectious Diseases, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6957'] 1072,33200890,Phase 3 Trial of Interleukin-1 Trap Rilonacept in Recurrent Pericarditis.,"BACKGROUND Interleukin-1 has been implicated as a mediator of recurrent pericarditis. The efficacy and safety of rilonacept, an interleukin-1α and interleukin-1β cytokine trap, were studied previously in a phase 2 trial involving patients with recurrent pericarditis. METHODS We conducted a phase 3 multicenter, double-blind, event-driven, randomized-withdrawal trial of rilonacept in patients with acute symptoms of recurrent pericarditis (as assessed on a patient-reported scale) and systemic inflammation (as shown by an elevated C-reactive protein [CRP] level). Patients presenting with pericarditis recurrence while receiving standard therapy were enrolled in a 12-week run-in period, during which rilonacept was initiated and background medications were discontinued. Patients who had a clinical response (i.e., met prespecified response criteria) were randomly assigned in a 1:1 ratio to receive continued rilonacept monotherapy or placebo, administered subcutaneously once weekly. The primary efficacy end point, assessed with a Cox proportional-hazards model, was the time to the first pericarditis recurrence. Safety was also assessed. RESULTS A total of 86 patients with pericarditis pain and an elevated CRP level were enrolled in the run-in period. During the run-in period, the median time to resolution or near-resolution of pain was 5 days, and the median time to normalization of the CRP level was 7 days. A total of 61 patients underwent randomization. During the randomized-withdrawal period, there were too few recurrence events in the rilonacept group to allow for the median time to the first adjudicated recurrence to be calculated; the median time to the first adjudicated recurrence in the placebo group was 8.6 weeks (95% confidence interval [CI], 4.0 to 11.7; hazard ratio in a Cox proportional-hazards model, 0.04; 95% CI, 0.01 to 0.18; P<0.001 by the log-rank test). During this period, 2 of 30 patients (7%) in the rilonacept group had a pericarditis recurrence, as compared with 23 of 31 patients (74%) in the placebo group. In the run-in period, 4 patients had adverse events leading to the discontinuation of rilonacept therapy. The most common adverse events with rilonacept were injection-site reactions and upper respiratory tract infections. CONCLUSIONS Among patients with recurrent pericarditis, rilonacept led to rapid resolution of recurrent pericarditis episodes and to a significantly lower risk of pericarditis recurrence than placebo. (Funded by Kiniksa Pharmaceuticals; RHAPSODY ClinicalTrials.gov number, NCT03737110.).",2021,"Among patients with recurrent pericarditis, rilonacept led to rapid resolution of recurrent pericarditis episodes and to a significantly lower risk of pericarditis recurrence than placebo.","['86 patients with pericarditis pain and an elevated CRP level were enrolled in the run-in period', 'patients with acute symptoms of recurrent pericarditis (as assessed on a patient-reported scale) and systemic inflammation (as shown by an elevated C-reactive protein [CRP] level', 'patients with recurrent pericarditis', 'Recurrent Pericarditis', '61 patients underwent randomization', 'Patients presenting with pericarditis recurrence while receiving', 'Patients who had a clinical response (i.e., met prespecified response criteria']","['rilonacept monotherapy or placebo', 'placebo', 'standard therapy', 'rilonacept', 'Interleukin-1 Trap Rilonacept']","['Safety', 'median time to resolution or near-resolution of pain', 'pericarditis recurrence', 'median time to normalization of the CRP level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031046', 'cui_str': 'Pericarditis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0742906', 'cui_str': 'Elevated C-reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C2343589', 'cui_str': 'rilonacept'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031046', 'cui_str': 'Pericarditis'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",86.0,0.325434,"Among patients with recurrent pericarditis, rilonacept led to rapid resolution of recurrent pericarditis episodes and to a significantly lower risk of pericarditis recurrence than placebo.","[{'ForeName': 'Allan L', 'Initials': 'AL', 'LastName': 'Klein', 'Affiliation': 'From the Center for the Diagnosis and Treatment of Pericardial Diseases, Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland (A.L.K., P.C.); University Cardiology, Cardiovascular, and Thoracic Department, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino and University of Turin, Turin (M.I.), the Department of Biomedical and Clinical Science, University of Milan, Fatebenefratelli Hospital, Milan (A.B.), and the Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome (A.I.) - all in Italy; Pauley Heart Center, Virginia Commonwealth University, Richmond (A.A.); Kiniksa Pharmaceuticals, Lexington, MA (F.F., A.P., J.F.P.); the Cardiology Unit, University of Vermont Medical Center, Burlington (M.L.); the Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel (B.S.L.); the Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis (D.L.), and the Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester (S.A.L.) - both in Minnesota; the Monash Cardiovascular Research Centre, Victorian Heart Institute, Monash University, Clayton, VIC, Australia (S.J.N.); and Kiniksa Pharmaceuticals, Hamilton, Bermuda (A.W.).'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Imazio', 'Affiliation': 'From the Center for the Diagnosis and Treatment of Pericardial Diseases, Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland (A.L.K., P.C.); University Cardiology, Cardiovascular, and Thoracic Department, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino and University of Turin, Turin (M.I.), the Department of Biomedical and Clinical Science, University of Milan, Fatebenefratelli Hospital, Milan (A.B.), and the Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome (A.I.) - all in Italy; Pauley Heart Center, Virginia Commonwealth University, Richmond (A.A.); Kiniksa Pharmaceuticals, Lexington, MA (F.F., A.P., J.F.P.); the Cardiology Unit, University of Vermont Medical Center, Burlington (M.L.); the Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel (B.S.L.); the Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis (D.L.), and the Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester (S.A.L.) - both in Minnesota; the Monash Cardiovascular Research Centre, Victorian Heart Institute, Monash University, Clayton, VIC, Australia (S.J.N.); and Kiniksa Pharmaceuticals, Hamilton, Bermuda (A.W.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Cremer', 'Affiliation': 'From the Center for the Diagnosis and Treatment of Pericardial Diseases, Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland (A.L.K., P.C.); University Cardiology, Cardiovascular, and Thoracic Department, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino and University of Turin, Turin (M.I.), the Department of Biomedical and Clinical Science, University of Milan, Fatebenefratelli Hospital, Milan (A.B.), and the Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome (A.I.) - all in Italy; Pauley Heart Center, Virginia Commonwealth University, Richmond (A.A.); Kiniksa Pharmaceuticals, Lexington, MA (F.F., A.P., J.F.P.); the Cardiology Unit, University of Vermont Medical Center, Burlington (M.L.); the Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel (B.S.L.); the Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis (D.L.), and the Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester (S.A.L.) - both in Minnesota; the Monash Cardiovascular Research Centre, Victorian Heart Institute, Monash University, Clayton, VIC, Australia (S.J.N.); and Kiniksa Pharmaceuticals, Hamilton, Bermuda (A.W.).'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Brucato', 'Affiliation': 'From the Center for the Diagnosis and Treatment of Pericardial Diseases, Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland (A.L.K., P.C.); University Cardiology, Cardiovascular, and Thoracic Department, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino and University of Turin, Turin (M.I.), the Department of Biomedical and Clinical Science, University of Milan, Fatebenefratelli Hospital, Milan (A.B.), and the Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome (A.I.) - all in Italy; Pauley Heart Center, Virginia Commonwealth University, Richmond (A.A.); Kiniksa Pharmaceuticals, Lexington, MA (F.F., A.P., J.F.P.); the Cardiology Unit, University of Vermont Medical Center, Burlington (M.L.); the Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel (B.S.L.); the Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis (D.L.), and the Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester (S.A.L.) - both in Minnesota; the Monash Cardiovascular Research Centre, Victorian Heart Institute, Monash University, Clayton, VIC, Australia (S.J.N.); and Kiniksa Pharmaceuticals, Hamilton, Bermuda (A.W.).'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Abbate', 'Affiliation': 'From the Center for the Diagnosis and Treatment of Pericardial Diseases, Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland (A.L.K., P.C.); University Cardiology, Cardiovascular, and Thoracic Department, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino and University of Turin, Turin (M.I.), the Department of Biomedical and Clinical Science, University of Milan, Fatebenefratelli Hospital, Milan (A.B.), and the Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome (A.I.) - all in Italy; Pauley Heart Center, Virginia Commonwealth University, Richmond (A.A.); Kiniksa Pharmaceuticals, Lexington, MA (F.F., A.P., J.F.P.); the Cardiology Unit, University of Vermont Medical Center, Burlington (M.L.); the Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel (B.S.L.); the Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis (D.L.), and the Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester (S.A.L.) - both in Minnesota; the Monash Cardiovascular Research Centre, Victorian Heart Institute, Monash University, Clayton, VIC, Australia (S.J.N.); and Kiniksa Pharmaceuticals, Hamilton, Bermuda (A.W.).'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Fang', 'Affiliation': 'From the Center for the Diagnosis and Treatment of Pericardial Diseases, Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland (A.L.K., P.C.); University Cardiology, Cardiovascular, and Thoracic Department, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino and University of Turin, Turin (M.I.), the Department of Biomedical and Clinical Science, University of Milan, Fatebenefratelli Hospital, Milan (A.B.), and the Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome (A.I.) - all in Italy; Pauley Heart Center, Virginia Commonwealth University, Richmond (A.A.); Kiniksa Pharmaceuticals, Lexington, MA (F.F., A.P., J.F.P.); the Cardiology Unit, University of Vermont Medical Center, Burlington (M.L.); the Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel (B.S.L.); the Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis (D.L.), and the Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester (S.A.L.) - both in Minnesota; the Monash Cardiovascular Research Centre, Victorian Heart Institute, Monash University, Clayton, VIC, Australia (S.J.N.); and Kiniksa Pharmaceuticals, Hamilton, Bermuda (A.W.).'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Insalaco', 'Affiliation': 'From the Center for the Diagnosis and Treatment of Pericardial Diseases, Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland (A.L.K., P.C.); University Cardiology, Cardiovascular, and Thoracic Department, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino and University of Turin, Turin (M.I.), the Department of Biomedical and Clinical Science, University of Milan, Fatebenefratelli Hospital, Milan (A.B.), and the Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome (A.I.) - all in Italy; Pauley Heart Center, Virginia Commonwealth University, Richmond (A.A.); Kiniksa Pharmaceuticals, Lexington, MA (F.F., A.P., J.F.P.); the Cardiology Unit, University of Vermont Medical Center, Burlington (M.L.); the Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel (B.S.L.); the Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis (D.L.), and the Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester (S.A.L.) - both in Minnesota; the Monash Cardiovascular Research Centre, Victorian Heart Institute, Monash University, Clayton, VIC, Australia (S.J.N.); and Kiniksa Pharmaceuticals, Hamilton, Bermuda (A.W.).'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'LeWinter', 'Affiliation': 'From the Center for the Diagnosis and Treatment of Pericardial Diseases, Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland (A.L.K., P.C.); University Cardiology, Cardiovascular, and Thoracic Department, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino and University of Turin, Turin (M.I.), the Department of Biomedical and Clinical Science, University of Milan, Fatebenefratelli Hospital, Milan (A.B.), and the Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome (A.I.) - all in Italy; Pauley Heart Center, Virginia Commonwealth University, Richmond (A.A.); Kiniksa Pharmaceuticals, Lexington, MA (F.F., A.P., J.F.P.); the Cardiology Unit, University of Vermont Medical Center, Burlington (M.L.); the Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel (B.S.L.); the Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis (D.L.), and the Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester (S.A.L.) - both in Minnesota; the Monash Cardiovascular Research Centre, Victorian Heart Institute, Monash University, Clayton, VIC, Australia (S.J.N.); and Kiniksa Pharmaceuticals, Hamilton, Bermuda (A.W.).'}, {'ForeName': 'Basil S', 'Initials': 'BS', 'LastName': 'Lewis', 'Affiliation': 'From the Center for the Diagnosis and Treatment of Pericardial Diseases, Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland (A.L.K., P.C.); University Cardiology, Cardiovascular, and Thoracic Department, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino and University of Turin, Turin (M.I.), the Department of Biomedical and Clinical Science, University of Milan, Fatebenefratelli Hospital, Milan (A.B.), and the Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome (A.I.) - all in Italy; Pauley Heart Center, Virginia Commonwealth University, Richmond (A.A.); Kiniksa Pharmaceuticals, Lexington, MA (F.F., A.P., J.F.P.); the Cardiology Unit, University of Vermont Medical Center, Burlington (M.L.); the Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel (B.S.L.); the Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis (D.L.), and the Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester (S.A.L.) - both in Minnesota; the Monash Cardiovascular Research Centre, Victorian Heart Institute, Monash University, Clayton, VIC, Australia (S.J.N.); and Kiniksa Pharmaceuticals, Hamilton, Bermuda (A.W.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lin', 'Affiliation': 'From the Center for the Diagnosis and Treatment of Pericardial Diseases, Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland (A.L.K., P.C.); University Cardiology, Cardiovascular, and Thoracic Department, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino and University of Turin, Turin (M.I.), the Department of Biomedical and Clinical Science, University of Milan, Fatebenefratelli Hospital, Milan (A.B.), and the Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome (A.I.) - all in Italy; Pauley Heart Center, Virginia Commonwealth University, Richmond (A.A.); Kiniksa Pharmaceuticals, Lexington, MA (F.F., A.P., J.F.P.); the Cardiology Unit, University of Vermont Medical Center, Burlington (M.L.); the Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel (B.S.L.); the Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis (D.L.), and the Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester (S.A.L.) - both in Minnesota; the Monash Cardiovascular Research Centre, Victorian Heart Institute, Monash University, Clayton, VIC, Australia (S.J.N.); and Kiniksa Pharmaceuticals, Hamilton, Bermuda (A.W.).'}, {'ForeName': 'Sushil A', 'Initials': 'SA', 'LastName': 'Luis', 'Affiliation': 'From the Center for the Diagnosis and Treatment of Pericardial Diseases, Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland (A.L.K., P.C.); University Cardiology, Cardiovascular, and Thoracic Department, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino and University of Turin, Turin (M.I.), the Department of Biomedical and Clinical Science, University of Milan, Fatebenefratelli Hospital, Milan (A.B.), and the Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome (A.I.) - all in Italy; Pauley Heart Center, Virginia Commonwealth University, Richmond (A.A.); Kiniksa Pharmaceuticals, Lexington, MA (F.F., A.P., J.F.P.); the Cardiology Unit, University of Vermont Medical Center, Burlington (M.L.); the Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel (B.S.L.); the Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis (D.L.), and the Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester (S.A.L.) - both in Minnesota; the Monash Cardiovascular Research Centre, Victorian Heart Institute, Monash University, Clayton, VIC, Australia (S.J.N.); and Kiniksa Pharmaceuticals, Hamilton, Bermuda (A.W.).'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Nicholls', 'Affiliation': 'From the Center for the Diagnosis and Treatment of Pericardial Diseases, Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland (A.L.K., P.C.); University Cardiology, Cardiovascular, and Thoracic Department, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino and University of Turin, Turin (M.I.), the Department of Biomedical and Clinical Science, University of Milan, Fatebenefratelli Hospital, Milan (A.B.), and the Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome (A.I.) - all in Italy; Pauley Heart Center, Virginia Commonwealth University, Richmond (A.A.); Kiniksa Pharmaceuticals, Lexington, MA (F.F., A.P., J.F.P.); the Cardiology Unit, University of Vermont Medical Center, Burlington (M.L.); the Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel (B.S.L.); the Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis (D.L.), and the Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester (S.A.L.) - both in Minnesota; the Monash Cardiovascular Research Centre, Victorian Heart Institute, Monash University, Clayton, VIC, Australia (S.J.N.); and Kiniksa Pharmaceuticals, Hamilton, Bermuda (A.W.).'}, {'ForeName': 'Arian', 'Initials': 'A', 'LastName': 'Pano', 'Affiliation': 'From the Center for the Diagnosis and Treatment of Pericardial Diseases, Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland (A.L.K., P.C.); University Cardiology, Cardiovascular, and Thoracic Department, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino and University of Turin, Turin (M.I.), the Department of Biomedical and Clinical Science, University of Milan, Fatebenefratelli Hospital, Milan (A.B.), and the Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome (A.I.) - all in Italy; Pauley Heart Center, Virginia Commonwealth University, Richmond (A.A.); Kiniksa Pharmaceuticals, Lexington, MA (F.F., A.P., J.F.P.); the Cardiology Unit, University of Vermont Medical Center, Burlington (M.L.); the Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel (B.S.L.); the Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis (D.L.), and the Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester (S.A.L.) - both in Minnesota; the Monash Cardiovascular Research Centre, Victorian Heart Institute, Monash University, Clayton, VIC, Australia (S.J.N.); and Kiniksa Pharmaceuticals, Hamilton, Bermuda (A.W.).'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Wheeler', 'Affiliation': 'From the Center for the Diagnosis and Treatment of Pericardial Diseases, Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland (A.L.K., P.C.); University Cardiology, Cardiovascular, and Thoracic Department, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino and University of Turin, Turin (M.I.), the Department of Biomedical and Clinical Science, University of Milan, Fatebenefratelli Hospital, Milan (A.B.), and the Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome (A.I.) - all in Italy; Pauley Heart Center, Virginia Commonwealth University, Richmond (A.A.); Kiniksa Pharmaceuticals, Lexington, MA (F.F., A.P., J.F.P.); the Cardiology Unit, University of Vermont Medical Center, Burlington (M.L.); the Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel (B.S.L.); the Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis (D.L.), and the Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester (S.A.L.) - both in Minnesota; the Monash Cardiovascular Research Centre, Victorian Heart Institute, Monash University, Clayton, VIC, Australia (S.J.N.); and Kiniksa Pharmaceuticals, Hamilton, Bermuda (A.W.).'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Paolini', 'Affiliation': 'From the Center for the Diagnosis and Treatment of Pericardial Diseases, Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland (A.L.K., P.C.); University Cardiology, Cardiovascular, and Thoracic Department, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino and University of Turin, Turin (M.I.), the Department of Biomedical and Clinical Science, University of Milan, Fatebenefratelli Hospital, Milan (A.B.), and the Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome (A.I.) - all in Italy; Pauley Heart Center, Virginia Commonwealth University, Richmond (A.A.); Kiniksa Pharmaceuticals, Lexington, MA (F.F., A.P., J.F.P.); the Cardiology Unit, University of Vermont Medical Center, Burlington (M.L.); the Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel (B.S.L.); the Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis (D.L.), and the Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester (S.A.L.) - both in Minnesota; the Monash Cardiovascular Research Centre, Victorian Heart Institute, Monash University, Clayton, VIC, Australia (S.J.N.); and Kiniksa Pharmaceuticals, Hamilton, Bermuda (A.W.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2027892'] 1073,33210382,A Phase Ib Study of NUC-1031 in Combination with Cisplatin for the First-Line Treatment of Patients with Advanced Biliary Tract Cancer (ABC-08).,"BACKGROUND Cisplatin/gemcitabine is standard first-line treatment for patients with advanced biliary tract cancer (ABC). NUC-1031 (phosphoramidate transformation of gemcitabine) is designed to enhance efficacy by maximizing intratumoral active metabolites. METHODS Patients with untreated ABC, Eastern Cooperative Oncology Group performance status 0-1 received NUC-1031 (625 or 725 mg/m 2 ) and cisplatin (25 mg/m 2 ) on days 1 and 8, every 21 days. Primary objectives were safety and maximum tolerated dose; secondary objectives were objective response rate (ORR), pharmacokinetics, progression-free survival (PFS), and overall survival (OS). RESULTS Twenty-one patients (median age 61 years, n = 13 male; 17 cholangiocarcinoma, 2 ampullary, and 2 gallbladder cancer) received NUC-1031 625 mg/m 2 (n = 8 and expansion n = 7; median six cycles) or 725 mg/m 2 (n = 6; median 7.5 cycles). Treatment was well tolerated; most common treatment-emergent grade 3-4 adverse events occurring in more than one patient with 625 mg/m 2 NUC-1031 were increased gamma-glutamyl transferase (GGT), 40%; alanine aminotransferase, 20%; bilirubin, 13%; neutropenia, 27%; decreased white cell count, 20%; thrombocytopenia, 13%; nausea, 13%; diarrhea, 13%; fatigue, 13%; and thrombus, 20% and with 725 mg/m 2 , increased GGT, 67%, and fatigue, 33%. NUC-1031 725 mg/m 2 was selected as the recommended dose with cisplatin in ABC. ORR was 33% (one complete response, six partial responses), DCR was 76%, median PFS was 7.2 months (95% confidence interval [CI], 4.3-10.1), and median OS was 9.6 months (95% CI, 6.7-13.1). The median estimates of area under the plasma concentration-time curve from time 0 to last measurable time and maximum concentration were highest for NUC-1031 (218-324 μg•h/mL and 309-889 μg/mL, respectively) and lowest for di-fluoro-deoxycytidine (0.47-1.56 μg•h/mL and 0.284-0.522 μg/mL, respectively). CONCLUSION This is the first study reporting on the combination of NUC-1031 with cisplatin in ABC and demonstrated a favorable safety profile; 725 mg/m 2 NUC-1031 in combination with cisplatin is undergoing phase III trial evaluation in ABC. (ClinicalTrials.gov ID: NCT02351765; EudraCT ID: 2015-000100-26). IMPLICATIONS FOR PRACTICE The prognosis for patients with advanced biliary tract cancer (ABC) is approximately 1 year, and new treatment options are required. The cisplatin/gemcitabine combination is standard first-line treatment for patients with ABC. NUC-1031 is a phosphoramidate transformation of gemcitabine and is designed to enhance efficacy by maximizing intratumoral active metabolites. This phase Ib study (ABC-08) demonstrated a favorable safety profile of NUC-1031 in combination with cisplatin for the first-line treatment of patients with ABC, and 725 mg/m 2 NUC-1031 was recommended in combination with cisplatin for phase III trial evaluation; the NuTide:121 global randomized study is currently enrolling.",2021,"The median plasma AUC 0-24 and C max estimates were highest for NUC-1031 (218-324 μg•h/mL and 309-889 μg/mL, respectively) and lowest for dFdC (0.47-1.56 μg•h/mL and 0.284-0.522 μg/mL, respectively). ","['Twenty-one patients (median age 61\u2009years, n=13 male; 17 cholangiocarcinoma, 2 ampullary and 2 gallbladder cancer', 'patients with ABC', 'patients with ABC, and 725mg', 'patients with advanced biliary tract cancer (ABC', 'patients with advanced biliary tract cancer (ABC-08', 'Patients with untreated ABC, ECOG-PS 0-1 received']","['NUC-1031 with cisplatin', 'Cisplatin/gemcitabine', 'NUC-1031 (phosphoramidate transformation of gemcitabine', 'cisplatin/gemcitabine', 'cisplatin', 'ORR', 'NUC-1031', 'gemcitabine', 'NUC-1031 ', 'EudraCT']","['diarrhea', 'ORR, pharmacokinetics, PFS and OS (secondary', 'nausea', 'median plasma AUC 0-24 and C max estimates', 'tolerated', 'neutropenia']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocarcinoma'}, {'cui': 'C0153452', 'cui_str': 'Malignant tumor of gallbladder'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0750952', 'cui_str': 'Malignant tumor of biliary tract'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0430797', 'cui_str': 'Electrocorticogram'}]","[{'cui': 'C3640933', 'cui_str': 'NUC-1031'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0896246', 'cui_str': 'phosphoramidate'}, {'cui': 'C3714584', 'cui_str': 'Transformation'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}]",,0.0445132,"The median plasma AUC 0-24 and C max estimates were highest for NUC-1031 (218-324 μg•h/mL and 309-889 μg/mL, respectively) and lowest for dFdC (0.47-1.56 μg•h/mL and 0.284-0.522 μg/mL, respectively). ","[{'ForeName': 'Mairéad G', 'Initials': 'MG', 'LastName': 'McNamara', 'Affiliation': 'Division\u2009of Cancer Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bridgewater', 'Affiliation': 'University College London, London, United Kingdom.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Palmer', 'Affiliation': 'Clatterbridge Cancer Centre and Liverpool Experimental Cancer Medicine Centre, Liverpool, United Kingdom.'}, {'ForeName': 'Olusola', 'Initials': 'O', 'LastName': 'Faluyi', 'Affiliation': 'Clatterbridge Cancer Centre and Liverpool Experimental Cancer Medicine Centre, Liverpool, United Kingdom.'}, {'ForeName': 'Harpreet', 'Initials': 'H', 'LastName': 'Wasan', 'Affiliation': 'Imperial College London, London, United Kingdom.'}, {'ForeName': 'Alkesh', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Department of Pharmacy, The Christie NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Ryder', 'Affiliation': 'Manchester Clinical Trials Unit, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Safia', 'Initials': 'S', 'LastName': 'Barber', 'Affiliation': 'Manchester Clinical Trials Unit, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Chathunissa', 'Initials': 'C', 'LastName': 'Gnanaranjan', 'Affiliation': 'Barts Cancer Institute, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Essam', 'Initials': 'E', 'LastName': 'Ghazaly', 'Affiliation': 'Barts Cancer Institute, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'T R Jeff', 'Initials': 'TRJ', 'LastName': 'Evans', 'Affiliation': 'Beatson West of Scotland Cancer Centre, University of Glasgow, United Kingdom.'}, {'ForeName': 'Juan W', 'Initials': 'JW', 'LastName': 'Valle', 'Affiliation': 'Division\u2009of Cancer Sciences, University of Manchester, Manchester, United Kingdom.'}]",The oncologist,['10.1002/onco.13598'] 1074,33210016,"Baseline characteristics and age-related macular degeneration in participants of the ""ASPirin in Reducing Events in the Elderly"" (ASPREE)-AMD trial.","Purpose To describe the baseline participant characteristics in the ASPREE-AMD study, investigating the effect of aspirin on AMD incidence and progression. Methods Australian participants from the ASPirin in Reducing Events in the Elderly (ASPREE) trial, randomized to 100 mg aspirin daily or placebo, had non-mydriatic, digital color fundus images graded according to the Beckman AMD classification. Associations with AMD were determined for baseline characteristics and genetic risk variants. Results ASPREE-AMD sub-study enrolled 4993 participants with gradable macular images. Median age was 73.4 years (IQR, 71.5, 76.6), 52% were female, 10% had diabetes mellitus, 73% had hypertension, and 44% were former/current smokers. Early, intermediate and late AMD (detected in 20.6%, 16.1%, 1.1%, respectively), significantly associated with age, were also associated with increasing HDL levels: OR = 1.52 (95%CI, 1.26, 1.84), OR = 1.43 (1.17, 1.77) and OR = 1.96 (1.02, 3.76), respectively. Female sex was associated with early [OR = 1.37 (1.16, 1.62)], and intermediate [OR = 1.35 (1.12, 1.63)] AMD, as was previous regular use of aspirin, with OR = 1.46 (1.11, 1.92) and OR = 1.37 (1.01, 1.85), respectively. Current smoking had increased odds for late AMD, OR = 4.02 (1.42, 11.36). Genetic risk variant rs3750846 ( ARMS2/HTRA1 ) was associated with each AMD stage ( p  < 0.001), risk variants rs570618 and rs10922109 ( CFH) with intermediate and late AMD ( p  < 0.001), and rare variant rs147859257 ( C3 ) with late AMD ( p  < 0.001). The randomized groups were well balanced for all analyzed AMD risk factors. Conclusions Observed associations are typical of AMD. The ASPREE-AMD clinical trial provides a unique opportunity to determine the risks and benefits of low-dose aspirin for AMD incidence and progression in elderly population. Trial registration Australian New Zealand Clinical Trial Registry: ACTRN 12613000755730.",2020,"Current smoking had increased odds for late AMD, OR = ","['Female sex was associated with early [OR\xa0', '4993 participants with gradable macular images', 'Median age was 73.4 years (IQR, 71.5, 76.6), 52% were female, 10% had diabetes mellitus, 73% had hypertension, and 44% were former/current smokers']","['aspirin daily or placebo', 'ASPirin', 'aspirin']","['AMD incidence and progression', 'intermediate and late AMD']","[{'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017921', 'cui_str': 'Generalized glycogenosis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205087', 'cui_str': 'Late'}]",4993.0,0.0965807,"Current smoking had increased odds for late AMD, OR = ","[{'ForeName': 'Liubov D', 'Initials': 'LD', 'LastName': 'Robman', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre 99 Commercial Road, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Le Thi', 'Initials': 'LT', 'LastName': 'Phuong Thao', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre 99 Commercial Road, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Robyn H', 'Initials': 'RH', 'LastName': 'Guymer', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Department of Surgery (Ophthalmology), University of Melbourne, 32 Gisborne Street, East Melbourne, VIC, 3002, Australia.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre 99 Commercial Road, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Woods', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre 99 Commercial Road, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Lauren Ab', 'Initials': 'LA', 'LastName': 'Hodgson', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Department of Surgery (Ophthalmology), University of Melbourne, 32 Gisborne Street, East Melbourne, VIC, 3002, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Phung', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre 99 Commercial Road, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Galina A', 'Initials': 'GA', 'LastName': 'Makeyeva', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Department of Surgery (Ophthalmology), University of Melbourne, 32 Gisborne Street, East Melbourne, VIC, 3002, Australia.'}, {'ForeName': 'Y-Anh', 'Initials': 'YA', 'LastName': 'Le-Pham', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre 99 Commercial Road, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Suzanne G', 'Initials': 'SG', 'LastName': 'Orchard', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre 99 Commercial Road, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Jewhara', 'Initials': 'J', 'LastName': 'Suleiman', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre 99 Commercial Road, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Maguire', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre 99 Commercial Road, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Trevaks', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre 99 Commercial Road, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Ward', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre 99 Commercial Road, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Moeen', 'Initials': 'M', 'LastName': 'Riaz', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre 99 Commercial Road, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lacaze', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre 99 Commercial Road, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Elsdon', 'Initials': 'E', 'LastName': 'Storey', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre 99 Commercial Road, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Walter P', 'Initials': 'WP', 'LastName': 'Abhayaratna', 'Affiliation': 'College of Health and Medicine, The Australian National University, Canberra, ACT, 0200, Australia.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS, 7000, Australia.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Ernst', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, Department of Family Medicine, Carver College of Medicine, The University of Iowa, Iowa City, IA, 52242, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre 99 Commercial Road, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre 99 Commercial Road, Melbourne, VIC, 3004, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100667'] 1075,33208640,"Prospective, Blinded, Randomized Controlled Trial of Stemless Versus Stemmed Humeral Components in Anatomic Total Shoulder Arthroplasty: Results at Short-Term Follow-up.","BACKGROUND Stemless humeral components for anatomic total shoulder arthroplasty (aTSA) have several reported potential benefits compared with stemmed implants. However, we are aware of no Level-I, randomized controlled trials (RCTs) that have compared stemless implants with stemmed implants in patients managed with aTSA. We sought to directly compare the short-term clinical and radiographic outcomes of stemless and stemmed implants to determine if the stemless implant is noninferior to the stemmed implant. METHODS We performed a prospective, multicenter, single-blinded RCT comparing stemless and short-stemmed implants in patients managed with aTSA. Range-of-motion measurements and American Shoulder and Elbow Surgeons (ASES), Single Assessment Numeric Evaluation (SANE), and Constant scores were obtained at multiple time points. Device-related complications were recorded. Radiographic evaluation for evidence of loosening, fractures, dislocation, or other component complications was performed. Statistical analysis for noninferiority was performed at 2 years of follow-up for 3 primary end points: ASES score, absence of device-related complications, and radiographic signs of loosening. All other data were compared between cohorts at all time points as secondary measures. RESULTS Two hundred and sixty-five shoulders (including 176 shoulders in male patients and 89 shoulders in female patients) were randomized and received the allocated treatment. The mean age of the patients (and standard deviation) was 62.6 ± 9.3 years, and 99% of the shoulders had a primary diagnosis of osteoarthritis. At 2 years, the mean ASES score was 92.5 ± 14.9 for the stemless cohort and 92.2 ± 13.5 for the stemmed cohort (p value for noninferiority test, <0.0001), the proportion of shoulders without device-related complications was 92% (107 of 116) for the stemless cohort and 93% (114 of 123) for the stemmed cohort (p value for noninferiority test, 0.0063), and no shoulder in either cohort had radiographic signs of loosening. Range-of-motion measurements and ASES, SANE, and Constant scores did not differ significantly between cohorts at any time point within the 2-year follow-up. CONCLUSIONS At 2 years of follow-up, the safety and effectiveness of the stemless humeral implant were noninferior to those of the stemmed humeral implant in patients managed with aTSA for the treatment of osteoarthritis. These short-term results are promising given the potential benefits of stemless designs over traditional, stemmed humeral components. LEVEL OF EVIDENCE Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"Range-of-motion measurements and ASES, SANE, and Constant scores did not differ significantly between cohorts at any time point within the 2-year follow-up. ","['mean age of the patients (and standard deviation) was 62.6 ± 9.3 years, and 99% of the shoulders had a primary diagnosis of osteoarthritis', 'Anatomic Total Shoulder Arthroplasty', 'Two hundred and sixty-five shoulders (including 176 shoulders in male patients and 89 shoulders in female patients', 'patients managed with aTSA']","['aTSA', 'Stemless Versus Stemmed Humeral Components']","['proportion of shoulders without device-related complications', 'Range-of-motion measurements and American Shoulder and Elbow Surgeons (ASES), Single Assessment Numeric Evaluation (SANE), and Constant scores', 'radiographic signs of loosening', 'mean ASES score', 'ASES score, absence of device-related complications, and radiographic signs of loosening', 'safety and effectiveness', 'Range-of-motion measurements and ASES, SANE, and Constant scores']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0186657', 'cui_str': 'Total shoulder replacement'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}]","[{'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0186657', 'cui_str': 'Total shoulder replacement'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0333050', 'cui_str': 'Loosening'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.214757,"Range-of-motion measurements and ASES, SANE, and Constant scores did not differ significantly between cohorts at any time point within the 2-year follow-up. ","[{'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Wiater', 'Affiliation': 'Department of Orthopedic Surgery, William Beaumont Hospital, Beaumont Health, Royal Oak, Michigan.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Levy', 'Affiliation': 'Holy Cross Orthopedic Research Institute, Fort Lauderdale, Florida.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Wright', 'Affiliation': 'Orthopaedics Northeast, Parkview Orthopaedic Hospital, Fort Wayne, Indiana.'}, {'ForeName': 'Stephen F', 'Initials': 'SF', 'LastName': 'Brockmeier', 'Affiliation': 'Department of Orthopaedic Surgery, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Duquin', 'Affiliation': 'Department of Orthopaedic Surgery, Jacobs School of Medicine, University at Buffalo, The State University of New York, Buffalo, New York.'}, {'ForeName': 'Jonathan O', 'Initials': 'JO', 'LastName': 'Wright', 'Affiliation': 'Department of Orthopedic Surgery, William Beaumont Hospital, Beaumont Health, Royal Oak, Michigan.'}, {'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Codd', 'Affiliation': ""Department of Orthopaedic Surgery, University of Maryland Medical System and St Joseph's Hospital, Towson, Maryland.""}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.01478'] 1076,33208641,"Single-Shot Liposomal Bupivacaine Reduces Postoperative Narcotic Use Following Outpatient Rotator Cuff Repair: A Prospective, Double-Blinded, Randomized Controlled Trial.","BACKGROUND Liposomal bupivacaine (LB) theoretically is longer-acting compared with conventional bupivacaine. The purpose of this study was to compare conventional bupivacaine combined with dexamethasone (control group), LB combined with conventional bupivacaine (LB group), and LB combined with dexamethasone and conventional bupivacaine (LBD group) in a perineural interscalene nerve block during ambulatory arthroscopic rotator cuff repair to determine if LB decreased postoperative narcotic consumption and pain. The effect of supplemental dexamethasone on prolonging the analgesic effect of LB was also assessed. METHODS This was a prospective, double-blinded, randomized controlled trial of 76 consecutive patients who underwent outpatient arthroscopic rotator cuff repair. Patients were randomized into the 3 interscalene-block treatment groups: control group (n = 26), LB group (n = 24), and LBD group (n = 26). Outcome measures included pain measured with a visual analog scale (VAS; 0 to 10) and narcotic consumption measured in oral morphine milligram equivalents (MME). Both were measured daily on postoperative day 0 through postoperative day 4. RESULTS Generalized estimating equation modeling revealed that narcotic consumption across all time points (postoperative days 0 to 4) was significantly lower in the LB group compared with the control group (mean difference, -8.5 MME; 95% confidence interval, -15.4 to -1.6; p = 0.015). Narcotic consumption was significantly higher in the control group on postoperative days 2 and 3 compared with the LB group (p = 0.004 and p = 0.02, respectively) and the LBD group (p = 0.01 and p = 0.003, respectively). There was no difference in narcotic consumption between the LBD and LB groups on any postoperative day. VAS pain scores in all groups were similar across all postoperative days. CONCLUSIONS Among patients undergoing outpatient arthroscopic rotator cuff repair, the addition of LB to conventional bupivacaine in interscalene nerve blocks appeared to be effective in controlling postoperative pain. Because LB with and without dexamethasone decreased postoperative narcotic use, LB should be considered for use in preoperative interscalene nerve blocks to reduce the reliance on narcotics for pain management. LEVEL OF EVIDENCE Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"Narcotic consumption was significantly higher in the control group on postoperative days 2 and 3 compared with the LB group (p = 0.004 and p = 0.02, respectively) and the LBD group (p = 0.01 and p = 0.003, respectively).","['patients undergoing outpatient arthroscopic rotator cuff repair', '76 consecutive patients who underwent outpatient arthroscopic rotator cuff repair', 'Outpatient Rotator Cuff Repair']","['bupivacaine', 'conventional bupivacaine', 'LBD', 'Single-Shot Liposomal Bupivacaine', 'dexamethasone', 'Liposomal bupivacaine (LB', 'dexamethasone (control group), LB combined with conventional bupivacaine (LB group), and LB combined with dexamethasone and conventional bupivacaine (LBD group', 'supplemental dexamethasone']","['Narcotic consumption', 'postoperative narcotic consumption and pain', 'Postoperative Narcotic Use', 'narcotic consumption', 'pain measured with a visual analog scale (VAS; 0 to 10) and narcotic consumption measured in oral morphine milligram equivalents (MME', 'analgesic effect of LB', 'VAS pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0751783', 'cui_str': 'Lafora disease'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0360457', 'cui_str': 'Morphine-containing product in oral dose form'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}]",76.0,0.336994,"Narcotic consumption was significantly higher in the control group on postoperative days 2 and 3 compared with the LB group (p = 0.004 and p = 0.02, respectively) and the LBD group (p = 0.01 and p = 0.003, respectively).","[{'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Baessler', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Moor', 'Affiliation': 'Department of Medical and Population Health Sciences Research, Herbert Wertheim College of Medicine, Florida International University, Miami, Florida.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Conrad', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Creighton', 'Affiliation': 'EmergeOrtho Triad Region, Greensboro, North Carolina.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Badman', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.20.00225'] 1077,33208642,Usefulness of an Accelerometer-Based Portable Navigation System for Total Knee Arthroplasty: A Multicenter Prospective Randomized Controlled Trial.,"BACKGROUND An accelerometer-based portable navigation system was recently introduced to improve prosthetic alignment during total knee arthroplasty (TKA). The purpose of this multicenter prospective randomized controlled trial (RCT) was to evaluate the effects of this accelerometer-based portable navigation system for achieving more accurate alignment during TKA in the clinical setting. METHODS One hundred patients with primary varus osteoarthritis of the knee were enrolled in this prospective RCT conducted in 5 hospitals. A navigation system was utilized in 50 patients (navigation group), and a conventional intramedullary femoral guide and an extramedullary tibial guide were utilized in 50 patients (conventional group). At 6 months postoperatively, weight-bearing radiographs were obtained of the whole operative leg. An experienced surgeon who was blinded to the treatment assignments then measured the alignment to 1 decimal place with use of computer software. Power analysis showed that 41 knees were required in each group. RESULTS There were no complications as a result of the use of the accelerometer-based portable navigation system. Postoperative radiographs were obtained in 45 patients from each group. There were no significant differences in sex, age, height, body weight, body mass index, preoperative femorotibial angle, and operative time between groups. The absolute differences of the femoral prosthesis (p = 0.01), tibial prosthesis (p < 0.01), and hip-knee-ankle angle (p < 0.01) from a neutral mechanical axis were less in the navigation group compared with those in the conventional group. Alignment outliers (>2° away from the neutral mechanical axis) of the tibial prosthesis and hip-knee-ankle angle were less in the navigation group (9% and 27%, respectively) compared with those in the conventional group (31% and 49%; p = 0.01 and p = 0.04, respectively). CONCLUSIONS To our knowledge, this is the first multicenter prospective RCT to evaluate an accelerometer-based portable navigation system. An accelerometer-based portable navigation system provides more accurate prosthetic and limb alignment in the coronal plane than conventional techniques, without extended operative time or an increased rate of complications. The results of this study may help orthopaedic surgeons decide whether or not to use an accelerometer-based portable navigation system. LEVEL OF EVIDENCE Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"The absolute differences of the femoral prosthesis (p = 0.01), tibial prosthesis (p < 0.01), and hip-knee-ankle angle (p < 0.01) from a neutral mechanical axis were less in the navigation group compared with those in the conventional group.","['total knee arthroplasty (TKA', 'One hundred patients with primary varus osteoarthritis of the knee were enrolled in this prospective RCT conducted in 5 hospitals', '50 patients (navigation group', 'Total Knee Arthroplasty']","['accelerometer-based portable navigation system', 'conventional intramedullary femoral guide and an extramedullary tibial guide', 'Accelerometer-Based Portable Navigation System']","['sex, age, height, body weight, body mass index, preoperative femorotibial angle, and operative time', 'Postoperative radiographs', 'hip-knee-ankle angle', 'neutral mechanical axis', 'tibial prosthesis', 'tibial prosthesis and hip-knee-ankle angle', 'rate of complications', 'femoral prosthesis']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0443345', 'cui_str': 'Varus'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4075648', 'cui_str': 'Navigation system'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1512957', 'cui_str': 'Intramedullary route'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}]","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}]",100.0,0.0579581,"The absolute differences of the femoral prosthesis (p = 0.01), tibial prosthesis (p < 0.01), and hip-knee-ankle angle (p < 0.01) from a neutral mechanical axis were less in the navigation group compared with those in the conventional group.","[{'ForeName': 'Yukihide', 'Initials': 'Y', 'LastName': 'Minoda', 'Affiliation': 'Department of Orthopaedic Surgery, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Kazue', 'Initials': 'K', 'LastName': 'Hayakawa', 'Affiliation': 'Department of Orthopaedic Surgery, Fujita Health University, Toyoake, Aichi, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Hagio', 'Affiliation': 'Department of Orthopaedic Surgery, Osaka Minami Medical Center, Kawachinagano, Osaka, Japan.'}, {'ForeName': 'Natsuo', 'Initials': 'N', 'LastName': 'Konishi', 'Affiliation': 'Department of Orthopaedic Surgery, Akita Kousei Medical Center, Akita, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Tamaki', 'Affiliation': 'Department of Orthopaedic Surgery, Funabashi Orthopaedic Hospital, Funabashi, Chiba, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Iwakiri', 'Affiliation': 'Department of Orthopaedic Surgery, Shiraniwa Hospital, Ikoma, Nara, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.20.00387'] 1078,33208649,"Considering the Value of Imageless, Accelerometer-Based, Intraoperative Mini-Navigation Systems in Contemporary Primary Total Knee Arthroplasty: Commentary on an article by Yukihide Minoda, MD, PhD, et al.: ""Usefulness of an Accelerometer-Based Portable Navigation System for Total Knee Arthroplasty. A Multicenter Prospective Randomized Controlled Trial"".",,2020,,"['Total Knee Arthroplasty', 'Contemporary Primary Total Knee Arthroplasty']",['Accelerometer-Based Portable Navigation System'],[],"[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4075648', 'cui_str': 'Navigation system'}]",[],,0.0447297,,"[{'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Kurmis', 'Affiliation': 'Discipline of Medical Specialties, Division of Health Sciences, University of Adelaide, Adelaide, South Australia, Australia.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.20.01534'] 1079,33215715,Heightened sensitivity to the caregiving environment during adolescence: implications for recovery following early-life adversity.,"BACKGROUND Adolescence has been proposed to be a period of heightened sensitivity to environmental influence. If true, adolescence may present a window of opportunity for recovery for children exposed to early-life adversity. Recent evidence supports adolescent recalibration of stress response systems following early-life adversity. However, it is unknown whether similar recovery occurs in other domains of functioning in adolescence. METHODS We use data from the Bucharest Early Intervention Project - a randomized controlled trial of foster care for children raised in psychosocially depriving institutions - to examine the associations of the caregiving environment with reward processing, executive functioning, and internalizing and externalizing psychopathology at ages 8, 12, and 16 years, and evaluate whether these associations change across development. RESULTS Higher quality caregiving in adolescence was associated with greater reward responsivity and lower levels of internalizing and externalizing symptoms, after covarying for the early-life caregiving environment. The associations of caregiving with executive function and internalizing and externalizing symptoms varied by age and were strongest at age 16 relative to ages 8 and 12 years. This heightened sensitivity to caregiving in adolescence was observed in both children with and without exposure to early psychosocial neglect. CONCLUSIONS Adolescence may be a period of heightened sensitivity to the caregiving environment, at least for some domains of functioning. For children who experience early psychosocial deprivation, this developmental period may be a window of opportunity for recovery of some functions. Albeit correlational, these findings suggest that it may be possible to reverse or remediate some of the lasting effects of early-life adversity with interventions that target caregiving during adolescence.",2020,"Higher quality caregiving in adolescence was associated with greater reward responsivity and lower levels of internalizing and externalizing symptoms, after covarying for the early-life caregiving environment.",['varied by age and were strongest at age 16 relative to ages 8 and 12\xa0years'],[],"['reward responsivity and lower levels of internalizing and externalizing symptoms', 'caregiving with executive function and internalizing and externalizing symptoms']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",,0.128357,"Higher quality caregiving in adolescence was associated with greater reward responsivity and lower levels of internalizing and externalizing symptoms, after covarying for the early-life caregiving environment.","[{'ForeName': 'Natalie L', 'Initials': 'NL', 'LastName': 'Colich', 'Affiliation': 'Department of Psychology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Sheridan', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Humphreys', 'Affiliation': 'Department of Psychology and Human Development, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wade', 'Affiliation': 'Department of Applied Psychology and Human Development, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Florin', 'Initials': 'F', 'LastName': 'Tibu', 'Affiliation': 'Department of Health and Human Development, Stefan cel Mare University of Suceava, Romania.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Nelson', 'Affiliation': ""Boston Children's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Zeanah', 'Affiliation': 'Department of Psychiatry, Tulane University School of Medicine, New Orleans, LA, USA.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Fox', 'Affiliation': 'Department of Human Development and Quantitative Methodology, University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Katie A', 'Initials': 'KA', 'LastName': 'McLaughlin', 'Affiliation': 'Department of Psychology, Harvard University, Boston, MA, USA.'}]","Journal of child psychology and psychiatry, and allied disciplines",['10.1111/jcpp.13347'] 1080,33215762,Long-Term Safety and Clinical Effects of Nilotinib in Parkinson's Disease.,"BACKGROUND Nilotinib is US Food and Drug Administration-approved for leukemia, and this open-label study investigated the safety, tolerability, and potential clinical effects of nilotinib in medically optimized patients with Parkinson's disease. OBJECTIVES Safety and tolerability were the primary objectives, and clinical outcomes were exploratory. METHODS A total of 63 patients completed a 15-month phase 2, double-blind, placebo-controlled study and were rerandomized 1:1 into an open-label study of nilotinib 150 mg versus 300 mg for 12 months. RESULTS Nilotinib was safe and tolerated, and no adverse effects seemed to be related to the drug, and no differences in adverse events were observed between groups. Exploratory clinical outcomes showed that nilotinib 300 mg was remarkably stable from baseline to 27 months using partial and total Unified Parkinson's Disease Scale (UPDRS). Nilotinib 150 mg versus 300 mg, significantly declined using partial or the sum of UPDRS Parts I and II. There was no significant difference in nilotinib 150 mg versus 300 mg using UPDRS Part III (on levodopa) and total UPDRS Parts I to III. Subgroup analysis showed that late-start nilotinib 150 mg significantly worsened using the sum of UPDRS Parts II + III and total UPDRS Parts I to III compared with late-start nilotinib 300 mg. Quality of life using the Parkinson's Disease Questionnaire in nilotinib 150 mg significantly declined between 15 and 27 months compared with nilotinib 300 mg, and there was no change in cognition using the Montreal Cognitive Assessment between groups. CONCLUSIONS This study provides evidence that nilotinib is safe and tolerated in Parkinson's disease. The exploratory clinical data will inform an adequately powered larger study to evaluate the efficacy of nilotinib 300 mg in Parkinson's disease. © 2020 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.",2021,"Quality of life using the Parkinson's Disease Questionnaire in nilotinib 150 mg significantly declined between 15 and 27 months compared with nilotinib 300 mg, and there was no change in cognition using the Montreal Cognitive Assessment between groups. ","['63 patients', ""medically optimized patients with Parkinson's disease"", '2020', ""Parkinson's Disease""]","['nilotinib 150\u2009mg versus 300\u2009mg for 12\u2009months', 'placebo']","['cognition using the Montreal Cognitive Assessment', 'safe and tolerated', ""Quality of life using the Parkinson's Disease Questionnaire"", 'adverse events', 'UPDRS Parts II\u2009+\u2009III and total UPDRS Parts', ""partial and total Unified Parkinson's Disease Scale (UPDRS""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C2920193', 'cui_str': 'nilotinib 150 MG'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",63.0,0.0238923,"Quality of life using the Parkinson's Disease Questionnaire in nilotinib 150 mg significantly declined between 15 and 27 months compared with nilotinib 300 mg, and there was no change in cognition using the Montreal Cognitive Assessment between groups. ","[{'ForeName': 'Fernando L', 'Initials': 'FL', 'LastName': 'Pagan', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, District of Columbia, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Wilmarth', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, District of Columbia, USA.'}, {'ForeName': 'Yasar', 'Initials': 'Y', 'LastName': 'Torres-Yaghi', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, District of Columbia, USA.'}, {'ForeName': 'Michaeline L', 'Initials': 'ML', 'LastName': 'Hebron', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, District of Columbia, USA.'}, {'ForeName': 'Sanjana', 'Initials': 'S', 'LastName': 'Mulki', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, District of Columbia, USA.'}, {'ForeName': 'Dalila', 'Initials': 'D', 'LastName': 'Ferrante', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, District of Columbia, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Matar', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, District of Columbia, USA.'}, {'ForeName': 'Jaeil', 'Initials': 'J', 'LastName': 'Ahn', 'Affiliation': 'Department of Biostatistics, Bioinformatics and Biomathematics, Georgetown University Medical Center, Washington, District of Columbia, USA.'}, {'ForeName': 'Charbel', 'Initials': 'C', 'LastName': 'Moussa', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, District of Columbia, USA.'}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.28389'] 1081,33225810,The effect of custom carbon ankle-foot orthosis alignment on roll-over shape and center of pressure velocity.,"BACKGROUND Maintaining an optimal rolling of the foot over the ground is thought to increase the stability and efficiency of pathologic gait. Ankle-foot orthoses are often prescribed to improve gait mechanics in individuals with lower extremity injuries; however, their design may compromise how the foot rolls over the ground. OBJECTIVES The aim of this study was to investigate the effects of the sagittal plane ankle-foot orthosis alignment on roll-over shape and center of pressure velocity in individuals with lower limb reconstructions. STUDY DESIGN Randomized cross-over study with a control group comparison. METHODS In total, 12 individuals with lower limb reconstruction who used a custom carbon ankle-foot orthosis and 12 uninjured controls underwent gait analysis. Ankle-foot orthosis users were tested in their clinically-provided ankle-foot orthosis alignment, with an alignment that was 3° more plantarflexed, and with an alignment that was 3° more dorsiflexed. Components of roll-over shape and center of pressure velocity were calculated from heel strike on the ankle-foot orthosis limb to contralateral heel strike. RESULTS Roll-over shape radius was not affected by 3° changes to alignment and was not significantly different from controls. Aligning the ankle-foot orthosis in more dorsiflexion than clinically provided resulted in a smaller peak center of pressure velocity that occurred later in stance. CONCLUSION Individuals using custom carbon ankle-foot orthoses can accommodate 3° alterations in the dorsiflexion or plantarflexion alignment.",2021,"RESULTS Roll-over shape radius was not affected by 3° changes to alignment and was not significantly different from controls.","['individuals with lower limb reconstructions', 'individuals with lower extremity injuries', '12 individuals with lower limb reconstruction who used a custom carbon ankle-foot orthosis and 12 uninjured controls underwent gait analysis']","['custom carbon ankle-foot orthosis alignment', 'sagittal plane ankle-foot orthosis alignment', 'custom carbon ankle-foot orthoses']","['pressure velocity', 'gait mechanics', 'roll-over shape and center of pressure velocity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C1283250', 'cui_str': 'Foot orthosis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0558820', 'cui_str': 'Examination of gait'}]","[{'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C1283250', 'cui_str': 'Foot orthosis'}, {'cui': 'C0935598', 'cui_str': 'Sagittal plane'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0543436', 'cui_str': 'Does roll over'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0205099', 'cui_str': 'Central'}]",12.0,0.0643265,"RESULTS Roll-over shape radius was not affected by 3° changes to alignment and was not significantly different from controls.","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Russell Esposito', 'Affiliation': 'DoD-VA Extremity Trauma and Amputation Center of Excellence, San Antonio, TX, USA.'}, {'ForeName': 'Mitchell D', 'Initials': 'MD', 'LastName': 'Ruble', 'Affiliation': 'Center for the Intrepid, Brooke Army Medical Center, San Antonio, TX, USA.'}, {'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Ikeda', 'Affiliation': 'DoD-VA Extremity Trauma and Amputation Center of Excellence, San Antonio, TX, USA.'}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Wilken', 'Affiliation': 'Center for the Intrepid, Brooke Army Medical Center, San Antonio, TX, USA.'}]",Prosthetics and orthotics international,['10.1177/0309364620971407'] 1082,33220855,"Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial.","BACKGROUND Older adults (aged ≥70 years) are at increased risk of severe disease and death if they develop COVID-19 and are therefore a priority for immunisation should an efficacious vaccine be developed. Immunogenicity of vaccines is often worse in older adults as a result of immunosenescence. We have reported the immunogenicity of a novel chimpanzee adenovirus-vectored vaccine, ChAdOx1 nCoV-19 (AZD1222), in young adults, and now describe the safety and immunogenicity of this vaccine in a wider range of participants, including adults aged 70 years and older. METHODS In this report of the phase 2 component of a single-blind, randomised, controlled, phase 2/3 trial (COV002), healthy adults aged 18 years and older were enrolled at two UK clinical research facilities, in an age-escalation manner, into 18-55 years, 56-69 years, and 70 years and older immunogenicity subgroups. Participants were eligible if they did not have severe or uncontrolled medical comorbidities or a high frailty score (if aged ≥65 years). First, participants were recruited to a low-dose cohort, and within each age group, participants were randomly assigned to receive either intramuscular ChAdOx1 nCoV-19 (2·2 × 10 10 virus particles) or a control vaccine, MenACWY, using block randomisation and stratified by age and dose group and study site, using the following ratios: in the 18-55 years group, 1:1 to either two doses of ChAdOx1 nCoV-19 or two doses of MenACWY; in the 56-69 years group, 3:1:3:1 to one dose of ChAdOx1 nCoV-19, one dose of MenACWY, two doses of ChAdOx1 nCoV-19, or two doses of MenACWY; and in the 70 years and older, 5:1:5:1 to one dose of ChAdOx1 nCoV-19, one dose of MenACWY, two doses of ChAdOx1 nCoV-19, or two doses of MenACWY. Prime-booster regimens were given 28 days apart. Participants were then recruited to the standard-dose cohort (3·5-6·5 × 10 10 virus particles of ChAdOx1 nCoV-19) and the same randomisation procedures were followed, except the 18-55 years group was assigned in a 5:1 ratio to two doses of ChAdOx1 nCoV-19 or two doses of MenACWY. Participants and investigators, but not staff administering the vaccine, were masked to vaccine allocation. The specific objectives of this report were to assess the safety and humoral and cellular immunogenicity of a single-dose and two-dose schedule in adults older than 55 years. Humoral responses at baseline and after each vaccination until 1 year after the booster were assessed using an in-house standardised ELISA, a multiplex immunoassay, and a live severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) microneutralisation assay (MNA 80 ). Cellular responses were assessed using an ex-vivo IFN-γ enzyme-linked immunospot assay. The coprimary outcomes of the trial were efficacy, as measured by the number of cases of symptomatic, virologically confirmed COVID-19, and safety, as measured by the occurrence of serious adverse events. Analyses were by group allocation in participants who received the vaccine. Here, we report the preliminary findings on safety, reactogenicity, and cellular and humoral immune responses. This study is ongoing and is registered with ClinicalTrials.gov, NCT04400838, and ISRCTN, 15281137. FINDINGS Between May 30 and Aug 8, 2020, 560 participants were enrolled: 160 aged 18-55 years (100 assigned to ChAdOx1 nCoV-19, 60 assigned to MenACWY), 160 aged 56-69 years (120 assigned to ChAdOx1 nCoV-19: 40 assigned to MenACWY), and 240 aged 70 years and older (200 assigned to ChAdOx1 nCoV-19: 40 assigned to MenACWY). Seven participants did not receive the boost dose of their assigned two-dose regimen, one participant received the incorrect vaccine, and three were excluded from immunogenicity analyses due to incorrectly labelled samples. 280 (50%) of 552 analysable participants were female. Local and systemic reactions were more common in participants given ChAdOx1 nCoV-19 than in those given the control vaccine, and similar in nature to those previously reported (injection-site pain, feeling feverish, muscle ache, headache), but were less common in older adults (aged ≥56 years) than younger adults. In those receiving two standard doses of ChAdOx1 nCoV-19, after the prime vaccination local reactions were reported in 43 (88%) of 49 participants in the 18-55 years group, 22 (73%) of 30 in the 56-69 years group, and 30 (61%) of 49 in the 70 years and older group, and systemic reactions in 42 (86%) participants in the 18-55 years group, 23 (77%) in the 56-69 years group, and 32 (65%) in the 70 years and older group. As of Oct 26, 2020, 13 serious adverse events occurred during the study period, none of which were considered to be related to either study vaccine. In participants who received two doses of vaccine, median anti-spike SARS-CoV-2 IgG responses 28 days after the boost dose were similar across the three age cohorts (standard-dose groups: 18-55 years, 20 713 arbitrary units [AU]/mL [IQR 13 898-33 550], n=39; 56-69 years, 16 170 AU/mL [10 233-40 353], n=26; and ≥70 years 17 561 AU/mL [9705-37 796], n=47; p=0·68). Neutralising antibody titres after a boost dose were similar across all age groups (median MNA 80 at day 42 in the standard-dose groups: 18-55 years, 193 [IQR 113-238], n=39; 56-69 years, 144 [119-347], n=20; and ≥70 years, 161 [73-323], n=47; p=0·40). By 14 days after the boost dose, 208 (>99%) of 209 boosted participants had neutralising antibody responses. T-cell responses peaked at day 14 after a single standard dose of ChAdOx1 nCoV-19 (18-55 years: median 1187 spot-forming cells [SFCs] per million peripheral blood mononuclear cells [IQR 841-2428], n=24; 56-69 years: 797 SFCs [383-1817], n=29; and ≥70 years: 977 SFCs [458-1914], n=48). INTERPRETATION ChAdOx1 nCoV-19 appears to be better tolerated in older adults than in younger adults and has similar immunogenicity across all age groups after a boost dose. Further assessment of the efficacy of this vaccine is warranted in all age groups and individuals with comorbidities. FUNDING UK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midlands NIHR Clinical Research Network, and AstraZeneca.",2021,"Neutralising antibody titres after a boost dose were similar across all age groups (median MNA 80 at day 42 in the standard-dose groups: 18-55 years, 193 [IQR 113-238], n=39; 56-69 years, 144 [119-347], n=20; and ≥70 years, 161 [73-323], n=47; p=0·40).","['older adults than in younger adults', 'adults aged 70 years and older', 'Older adults (aged ≥70 years', 'adults older than 55 years', '560 participants were enrolled: 160 aged 18-55 years (100 assigned to ChAdOx1 nCoV-19, 60 assigned to MenACWY), 160 aged 56-69 years (120 assigned to ChAdOx1 nCoV-19: 40 assigned to MenACWY), and 240 aged 70 years and older (200 assigned to ChAdOx1 nCoV-19: 40 assigned to MenACWY', 'Participants were eligible if they did not have severe or uncontrolled medical comorbidities or a high frailty score (if aged ≥65 years', 'young adults', 'older adults', '280 (50%) of 552 analysable participants were female', 'Between May 30 and Aug 8, 2020', 'all age groups and individuals with comorbidities', 'older adults (aged ≥56 years) than younger adults', 'n=24; 56-69 years: 797 SFCs [383-1817], n=29; and ≥70 years: 977 SFCs [458-1914], n=48', 'Participants were then recruited to the standard-dose cohort (3·5-6·5', 'young and old adults (COV002', 'healthy adults aged 18 years and older were enrolled at two UK clinical research facilities, in an age-escalation manner, into 18-55 years, 56-69 years, and 70 years and older immunogenicity subgroups']","['intramuscular ChAdOx1 nCoV-19 (2·2', 'ChAdOx1 nCoV-19 or two doses of MenACWY', 'control vaccine, MenACWY', 'ChAdOx1 nCoV-19 vaccine', 'ChAdOx1 nCoV-19, one dose of MenACWY, two doses of ChAdOx1 nCoV-19, or two doses of MenACWY', 'ChAdOx1 nCoV-19', 'vaccine, median anti-spike SARS-CoV-2 IgG responses', 'vaccine']","['Immunogenicity', 'T-cell responses', 'number of cases of symptomatic, virologically confirmed COVID-19, and safety, as measured by the occurrence of serious adverse events', 'Local and systemic reactions', 'Neutralising antibody titres', 'systemic reactions', 'Safety and immunogenicity', 'Humoral responses', 'neutralising antibody responses', 'adverse events', 'safety, reactogenicity, and cellular and humoral immune responses', 'safety and humoral and cellular immunogenicity']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C2003457', 'cui_str': 'MenACWY'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4521536', 'cui_str': 'US Military enlisted E7'}, {'cui': 'C5191377', 'cui_str': '458'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C2003457', 'cui_str': 'MenACWY'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}]","[{'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0020967', 'cui_str': 'Humoral Immunity'}]",560.0,0.415156,"Neutralising antibody titres after a boost dose were similar across all age groups (median MNA 80 at day 42 in the standard-dose groups: 18-55 years, 193 [IQR 113-238], n=39; 56-69 years, 144 [119-347], n=20; and ≥70 years, 161 [73-323], n=47; p=0·40).","[{'ForeName': 'Maheshi N', 'Initials': 'MN', 'LastName': 'Ramasamy', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK. Electronic address: maheshi.ramasamy@paediatrics.ox.ac.uk.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Minassian', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK.'}, {'ForeName': 'Katie J', 'Initials': 'KJ', 'LastName': 'Ewer', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Flaxman', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK.'}, {'ForeName': 'Pedro M', 'Initials': 'PM', 'LastName': 'Folegatti', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Owens', 'Affiliation': 'NIHR Clinical Research Facility, University Hospital Southampton NHS Trust, Southampton, UK.'}, {'ForeName': 'Merryn', 'Initials': 'M', 'LastName': 'Voysey', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Parvinder K', 'Initials': 'PK', 'LastName': 'Aley', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Angus', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Babbage', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Belij-Rammerstorfer', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Berry', 'Affiliation': 'NIHR Clinical Research Facility, University Hospital Southampton NHS Trust, Southampton, UK.'}, {'ForeName': 'Sagida', 'Initials': 'S', 'LastName': 'Bibi', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Mustapha', 'Initials': 'M', 'LastName': 'Bittaye', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Cathie', 'Affiliation': 'Paediatric Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Chappell', 'Affiliation': 'NIHR Clinical Research Facility, University Hospital Southampton NHS Trust, Southampton, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Charlton', 'Affiliation': 'National Infection Service, Public Health England, Porton Down, Salisbury, UK.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Cicconi', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Clutterbuck', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Colin-Jones', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Dold', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Katherine R W', 'Initials': 'KRW', 'LastName': 'Emary', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sofiya', 'Initials': 'S', 'LastName': 'Fedosyuk', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Fuskova', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Gbesemete', 'Affiliation': 'NIHR Clinical Research Facility, University Hospital Southampton NHS Trust, Southampton, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Green', 'Affiliation': 'Clinical Biomanufacturing Facility, University of Oxford, Oxford, UK.'}, {'ForeName': 'Bassam', 'Initials': 'B', 'LastName': 'Hallis', 'Affiliation': 'National Infection Service, Public Health England, Porton Down, Salisbury, UK.'}, {'ForeName': 'Mimi M', 'Initials': 'MM', 'LastName': 'Hou', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Jenkin', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK.'}, {'ForeName': 'Carina C D', 'Initials': 'CCD', 'LastName': 'Joe', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Kelly', 'Affiliation': 'AstraZeneca BioPharmaceuticals Research and Development, Washington, DC, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kerridge', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Lawrie', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Lelliott', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'May N', 'Initials': 'MN', 'LastName': 'Lwin', 'Affiliation': 'NIHR Clinical Research Facility, University Hospital Southampton NHS Trust, Southampton, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Makinson', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK.'}, {'ForeName': 'Natalie G', 'Initials': 'NG', 'LastName': 'Marchevsky', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Yama', 'Initials': 'Y', 'LastName': 'Mujadidi', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alasdair P S', 'Initials': 'APS', 'LastName': 'Munro', 'Affiliation': 'NIHR Clinical Research Facility, University Hospital Southampton NHS Trust, Southampton, UK.'}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Pacurar', 'Affiliation': 'NIHR Clinical Research Facility, University Hospital Southampton NHS Trust, Southampton, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Plested', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'Rand', 'Affiliation': 'NIHR Clinical Research Facility, University Hospital Southampton NHS Trust, Southampton, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rawlinson', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Rhead', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Robinson', 'Affiliation': 'Nuffield Department of Medicine, and Oxford Centre for Clinical Tropical Medicine and Global Health, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Ritchie', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Ross-Russell', 'Affiliation': 'NIHR Clinical Research Facility, University Hospital Southampton NHS Trust, Southampton, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Saich', 'Affiliation': 'NIHR Clinical Research Facility, University Hospital Southampton NHS Trust, Southampton, UK.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Catherine C', 'Initials': 'CC', 'LastName': 'Smith', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Snape', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rinn', 'Initials': 'R', 'LastName': 'Song', 'Affiliation': ""Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; Division of Infectious Diseases, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Tarrant', 'Affiliation': 'Clinical Biomanufacturing Facility, University of Oxford, Oxford, UK.'}, {'ForeName': 'Yrene', 'Initials': 'Y', 'LastName': 'Themistocleous', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK.'}, {'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Thomas', 'Affiliation': 'National Infection Service, Public Health England, Porton Down, Salisbury, UK.'}, {'ForeName': 'Tonya L', 'Initials': 'TL', 'LastName': 'Villafana', 'Affiliation': 'AstraZeneca BioPharmaceuticals Research and Development, Bethesda, MA, USA.'}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Warren', 'Affiliation': 'NIHR Clinical Research Facility, University Hospital Southampton NHS Trust, Southampton, UK.'}, {'ForeName': 'Marion E E', 'Initials': 'MEE', 'LastName': 'Watson', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alexander D', 'Initials': 'AD', 'LastName': 'Douglas', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Adrian V S', 'Initials': 'AVS', 'LastName': 'Hill', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Lambe', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Gilbert', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Saul N', 'Initials': 'SN', 'LastName': 'Faust', 'Affiliation': 'NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Trust and Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Pollard', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)32466-1'] 1083,32695998,Impact of Fiber-Based Enteral Nutrition on the Gut Microbiome of ICU Patients Receiving Broad-Spectrum Antibiotics: A Randomized Pilot Trial.,"Objectives Dietary fiber increases the abundance of bacteria that metabolize fiber into short-chain fatty acids and confers resistance against gut colonization with multidrug-resistant bacteria. This pilot trial estimated the effect of fiber on gut short-chain fatty acid-producing bacteria in the ICU. Design Randomized, controlled, open label trial. Setting Medical ICU. Patients Twenty ICU adults receiving broad-spectrum IV antibiotics for sepsis. Intervention 1:1 randomization to enteral nutrition with mixed soy- and oat-derived fiber (14.3 g fiber/L) versus calorie- and micronutrient-identical enteral nutrition with 0 g/L fiber. Measurements Rectal swabs and whole stools were collected at baseline and on study Days 3, 7, 14, and 30. The primary outcome was within-individual change in the cumulative relative abundance of short-chain fatty acid-producing taxa from baseline to Day 3 based on 16S sequencing of rectal swabs. The secondary outcome was Day 3 cumulative short-chain fatty acid levels based on mass spectrometry of whole stools. Analyses were all intent to treat. Main Results By Day 3, the fiber group received a median of 32.1 g fiber cumulatively (interquartile range, 17.6-54.6) versus 0 g fiber (interquartile range, 0-4.0) in the no fiber group. The median within-individual change in short-chain fatty acid producer relative abundance from baseline to Day 3 was +61% (interquartile range -51 to +1,688) in the fiber group versus -46% (interquartile range, -78 to +13) in the no fiber group ( p = 0.28). Whole stool short-chain fatty acid levels on Day 3 were a median of 707 μg short-chain fatty acids/g stool (interquartile range, 190-7,265) in the fiber group versus 118 μg short-chain fatty acids/g stool (interquartile range, 22-1,195) in the no fiber group ( p = 0.16). Conclusions Enteral fiber was associated with nonsignificant trends toward increased relative abundance of short-chain fatty acid-producing bacteria and increased short-chain fatty acid levels among ICU patients receiving broad-spectrum IV antibiotics. Larger studies should be undertaken and our results can be used for effect size estimates.",2020,"The median within-individual change in short-chain fatty acid producer relative abundance from baseline to Day 3 was +61% (interquartile range -51 to +1,688) in the fiber group versus -46% (interquartile range, -78 to +13) in the no fiber group (","['Patients\n\n\nTwenty ICU adults receiving broad-spectrum IV antibiotics for sepsis', 'ICU Patients Receiving Broad-Spectrum Antibiotics']","['enteral nutrition with mixed soy- and oat-derived fiber (14.3\u2009g fiber/L) versus calorie- and micronutrient-identical enteral nutrition with 0\u2009g/L fiber', 'Fiber-Based Enteral Nutrition', 'fiber on gut short-chain fatty acid-producing bacteria']","['relative abundance of short-chain fatty acid-producing bacteria and increased short-chain fatty acid levels', 'Measurements\n\n\nRectal swabs and whole stools', 'Day 3 cumulative short-chain fatty acid levels based on mass spectrometry of whole stools', 'cumulative relative abundance of short-chain fatty acid-producing taxa from baseline to Day 3 based on 16S sequencing of rectal swabs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}]","[{'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0028753', 'cui_str': 'Oats'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0444215', 'cui_str': 'Rectal swab'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0037813', 'cui_str': 'Mass spectrometry measurement'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}]",20.0,0.138437,"The median within-individual change in short-chain fatty acid producer relative abundance from baseline to Day 3 was +61% (interquartile range -51 to +1,688) in the fiber group versus -46% (interquartile range, -78 to +13) in the no fiber group (","[{'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Freedberg', 'Affiliation': 'Division of Digestive and Liver Diseases, NewYork-Presbyterian Hospital, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Messina', 'Affiliation': 'Department of Food and Nutrition, NewYork-Presbyterian Hospital, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Elissa', 'Initials': 'E', 'LastName': 'Lynch', 'Affiliation': 'Division of Digestive and Liver Diseases, NewYork-Presbyterian Hospital, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Tess', 'Affiliation': 'Department of Food and Nutrition, NewYork-Presbyterian Hospital, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Miracle', 'Affiliation': 'Department of Food and Nutrition, NewYork-Presbyterian Hospital, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Chong', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, NewYork-Presbyterian Hospital, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Romina', 'Initials': 'R', 'LastName': 'Wahab', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, NewYork-Presbyterian Hospital, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Julian A', 'Initials': 'JA', 'LastName': 'Abrams', 'Affiliation': 'Division of Digestive and Liver Diseases, NewYork-Presbyterian Hospital, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Harris H', 'Initials': 'HH', 'LastName': 'Wang', 'Affiliation': 'Department of Systems and Synthetic Biology, NewYork-Presbyterian Hospital, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Munck', 'Affiliation': 'Department of Systems and Synthetic Biology, NewYork-Presbyterian Hospital, Columbia University Medical Center, New York, NY.'}]",Critical care explorations,['10.1097/CCE.0000000000000135'] 1084,32693214,Biomarkers of Type 2 Airway Inflammation as Predictors of Loss of Asthma Control During Step-Down Therapy for Well-Controlled Disease: The Long-Acting Beta-Agonist Step-Down Study (LASST).,"BACKGROUND Biomarkers that can predict loss of asthma control among patients being considered for step-down therapy in well-controlled disease are lacking. OBJECTIVE To evaluate whether baseline biomarkers of type 2 airway inflammation and/or serial measurement of fractional exhaled nitric oxide (Feno) predict loss of asthma control as therapy is stepped down. METHODS In subanalyses of a multicenter randomized, double-blind, parallel 3-arm trial comparing strategies for step-down therapy in well-controlled asthma (Long-Acting Beta-Agonist Step-Down Study), we assessed whether baseline atopy as determined by serum aeroallergen allergy screening test (Phadiatop), baseline serum eosinophil peroxidase, or baseline or serial Feno measurements during follow-up predicted the time to loss of asthma control among participants. Loss of asthma control was defined in the study protocol. We analyzed these associations in adjusted models including all participants, after testing for interactions with assignment to each of the 3 treatment groups (continuation of stable dose of combination inhaled corticosteroid-long-acting beta-agonist, step-down of inhaled corticosteroid, or discontinuation of long-acting bronchodilator). RESULTS Four hundred forty-seven of the 553 Long-Acting Beta-Agonist Step-Down Study participants who were randomized to 1 of 3 treatment arms and had at least 1 biomarker measurement were included in this analysis. At baseline, higher levels of Feno were significantly associated with greater levels of multiallergen IgE levels (P < .001), but not with serum eosinophil peroxidase (P = .742). Among all participants as a group, elevations in baseline biomarkers were not predictive of a higher risk of treatment failure. In addition, Feno levels measured serially at 6-week intervals demonstrated that compared with participants with low levels (<25 parts per billion), those with intermediate (25-50 parts per billion) and high (>50 parts per billion) levels did not have significantly increased likelihood of subsequent treatment failure (hazard ratios, 1.03 [95% CI, 0.59-1.78] and 1.29 [95% CI, 0.65-2.54], respectively). There were no significant interactions of treatment group and baseline biomarkers. CONCLUSIONS In patients with well-controlled asthma, neither baseline levels of type 2 airway inflammatory biomarkers nor serial measures of Feno are strong predictors of treatment failure.",2020,"In patients with well-controlled asthma, neither baseline levels of type 2 airway inflammatory biomarkers nor serial measures of FeNO are strong predictors of treatment failure.",['Four hundred and forty-seven of the 553 LASST participants who were randomized to one of 3 treatment arms and had at least one biomarker measurement were included in this analysis'],"['combination ICS-LABA, step-down of inhaled corticosteroid (ICS), or discontinuation of long acting bronchodilator (LABA']","['levels of FeNO', 'likelihood of subsequent treatment failure', 'FeNO levels', 'levels of multi-allergen IgE levels', 'serum aeroallergen allergy screening test (Phadiatop), baseline serum eosinophil peroxidase (EpX), or baseline or serial FeNO measurements', 'Loss of asthma control']","[{'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0001697', 'cui_str': 'Aeroallergen'}, {'cui': 'C1273434', 'cui_str': 'Allergy screening test'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",553.0,0.395791,"In patients with well-controlled asthma, neither baseline levels of type 2 airway inflammatory biomarkers nor serial measures of FeNO are strong predictors of treatment failure.","[{'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Bose', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY; Johns Hopkins School of Medicine, Baltimore, Md.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Bime', 'Affiliation': 'University of Arizona College of Medicine, Tucson, Ariz.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Henderson', 'Affiliation': 'Johns Hopkins School of Medicine, Baltimore, Md.'}, {'ForeName': 'Kathryn V', 'Initials': 'KV', 'LastName': 'Blake', 'Affiliation': ""Nemours Children's Health System, Jacksonville, Fla.""}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'Washington University School of Medicine, St Louis, Mo.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'DiMango', 'Affiliation': 'Columbia University College of Physicians and Surgeons, New York, NY.'}, {'ForeName': 'Nicola A', 'Initials': 'NA', 'LastName': 'Hanania', 'Affiliation': 'Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Janet T', 'Initials': 'JT', 'LastName': 'Holbrook', 'Affiliation': 'Johns Hopkins School of Medicine, Baltimore, Md.'}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Irvin', 'Affiliation': 'University of Vermont, Burlington, Vt.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Kraft', 'Affiliation': 'University of Arizona College of Medicine, Tucson, Ariz.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Peters', 'Affiliation': 'Wake Forest University School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Reibman', 'Affiliation': 'New York University School of Medicine, New York, NY.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Sugar', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Md.'}, {'ForeName': 'Kaharu', 'Initials': 'K', 'LastName': 'Sumino', 'Affiliation': 'Washington University School of Medicine, St Louis, Mo.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wise', 'Affiliation': 'Johns Hopkins School of Medicine, Baltimore, Md.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Rogers', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: linda.rogers@mssm.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.06.067'] 1085,32702101,Nonsteroidal Anti-inflammatory Drugs vs Cognitive Behavioral Therapy for Arthritis Pain: A Randomized Withdrawal Trial.,"Importance Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly prescribed for knee osteoarthritis. However, they are associated with uncertain long-term clinical benefit and significant toxic effects. Objective To evaluate whether discontinuing NSAIDs and engaging in a telephone-based cognitive behavioral therapy (CBT) program is noninferior to continuing NSAIDs for patients with knee osteoarthritis. Design, Setting, and Participants The Stopping NSAIDs for Arthritis Pain multicenter randomized withdrawal trial was conducted for 364 patients taking NSAIDs for knee osteoarthritis pain on most days of the week for at least 3 months between September 1, 2013, and September 30, 2018. Analysis was performed on an intent-to-treat basis. Interventions Participants discontinued their current NSAID and took 15 mg per day of meloxicam daily during a 2-week run-in period. Those who remained eligible were randomized in a 1:1 ratio to receive meloxicam or placebo for 4 weeks (blinded phase 1). Participants receiving meloxicam then continued this medication for 10 weeks, while those receiving placebo participated in a 10-week CBT program (unblinded phase 2). Main Outcomes and Measures The primary outcome measure was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score at 4 weeks with the noninferiority margin set at 1. Secondary outcomes included the area under the curve of the pain score after 4 weeks as well as the WOMAC pain score, area under the curve of the pain score, WOMAC disability score, and global impression of change after treatment at 14 weeks. Results A total of 180 participants (161 men; mean [SD] age, 58. 2 [11.8] years) were randomized to receive placebo followed by CBT, and a total of 184 participants (154 men; mean [SD] age, 58.5 [10.0] years) were randomized to receive meloxicam. After adjustment for baseline pain and study site, the estimated mean difference in WOMAC pain score between the placebo and meloxicam groups after 4 weeks was 1.4 (95% CI, 0.8-2.0; noninferiority test P = .92). At week 14, the adjusted mean difference in WOMAC pain score between the placebo (followed by CBT) and meloxicam groups was 0.8 (95% CI, 0.2-1.4; noninferiority P = .28). There was no statistically significant difference in the global impression of change (mean difference in scores, -0.2; 95% CI, -0.4 to 0.1; P = .15) or lower extremity disability (mean difference in scores, 0.9; 95% CI, -1.4 to 3.2; P = .45) between the 2 groups after 14 weeks. Conclusions and Relevance Among patients with knee osteoarthritis, placebo and CBT (after placebo) are inferior to meloxicam. However, the WOMAC pain score differences between the 2 groups were small, and there were no statistically significant differences in participants' global impression of change or function after 14 weeks. Trial Registration ClinicalTrials.gov Identifier: NCT01799213.",2020,"There was no statistically significant difference in the global impression of change (mean difference in scores, -0.2; 95% CI, -0.4 to 0.1; P = .15) or lower extremity disability (mean difference in scores, 0.9; 95% CI, -1.4 to 3.2; P = .45) between the 2 groups after 14 weeks. ","['Arthritis Pain', '184 participants (154 men; mean [SD] age, 58.5 [10.0] years', '180 participants (161 men; mean [SD] age, 58', '364 patients taking NSAIDs for knee osteoarthritis pain on most days of the week for at least 3 months between September 1, 2013, and September 30, 2018', 'patients with knee osteoarthritis']","['discontinuing NSAIDs and engaging in a telephone-based cognitive behavioral therapy (CBT) program', 'meloxicam', 'placebo followed by CBT', 'Nonsteroidal Anti-inflammatory Drugs vs Cognitive Behavioral Therapy', 'Nonsteroidal anti-inflammatory drugs (NSAIDs', 'placebo and CBT (after placebo', 'meloxicam or placebo', 'placebo']","['Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score', 'area under the curve of the pain score after 4 weeks as well as the WOMAC pain score, area under the curve of the pain score, WOMAC disability score, and global impression of change', 'extremity disability', 'global impression of change', 'WOMAC pain score differences', 'WOMAC pain score']","[{'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0585023', 'cui_str': 'Days of the week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0083381', 'cui_str': 'meloxicam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}]",180.0,0.518584,"There was no statistically significant difference in the global impression of change (mean difference in scores, -0.2; 95% CI, -0.4 to 0.1; P = .15) or lower extremity disability (mean difference in scores, 0.9; 95% CI, -1.4 to 3.2; P = .45) between the 2 groups after 14 weeks. ","[{'ForeName': 'Liana', 'Initials': 'L', 'LastName': 'Fraenkel', 'Affiliation': 'Veterans Affairs Connecticut Healthcare System, West Haven.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Buta', 'Affiliation': 'Veterans Affairs Connecticut Healthcare System, West Haven.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Suter', 'Affiliation': 'Veterans Affairs Connecticut Healthcare System, West Haven.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Dubreuil', 'Affiliation': 'Veterans Affairs Boston Healthcare System, Boston, Massachusetts.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Levy', 'Affiliation': 'North Florida/South Georgia Veterans Health System, Gainesville, Florida.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Najem', 'Affiliation': 'Providence Veterans Affairs Medical Center, Providence, Rhode Island.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Brennan', 'Affiliation': 'Veterans Affairs Connecticut Healthcare System, West Haven.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Corn', 'Affiliation': 'Veterans Affairs Connecticut Healthcare System, West Haven.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kerns', 'Affiliation': 'Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Goulet', 'Affiliation': 'Veterans Affairs Connecticut Healthcare System, West Haven.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.2821'] 1086,32710628,"Dropout, response, and abstinence outcomes of a national text-messaging smoking cessation intervention for teens, SmokeFreeTeen.","Although text-messaging interventions are effective for smoking cessation, few target teens in the USA and little is known about their effectiveness. The purpose of this manuscript is to examine correlates of dropout, response to smoking status prompts, and abstinence rates among subscribers of SmokeFreeTeen, a free, publicly available text-messaging smoking cessation intervention sponsored by the National Cancer Institute's SmokeFree.Gov initiative, on quit day through 1 month follow-up. In a sample of teens (N = 2,685), aged 13-19, we examined demographics, smoking frequency, cigarettes smoked per day, prequit intervention time (i.e., maximum of 14 days of prequit day preparation), and number of quit attempts as correlates of response and abstinence rates among program initiators (i.e., participants who reached quit day but dropped out on or before intervention end) and completers (i.e., participants who reached quit day and completed the intervention). We also conducted Cox regression analysis of time from quit day to dropout by daily and nondaily smoking status. Two-thirds (n = 1,733, 64.54%) dropped out before the intervention ended, with dropout rates peaking on quit day (n = 289, 13.10%). Response rate to smoking status prompts remained below 30% throughout the intervention. At intervention end and 1 month follow-up, abstinence was 2.63% and 2.55% among program initiators, whereas abstinence was 6.09% and 6.01% among program completers. Dropout, response, and abstinence rates did not consistently differ by subscriber characteristics. Prequit time was associated with decreased likelihood of dropping out (adjusted hazards ratio: 0.94, confidence interval [CI]: 0.93-0.95), responding to smoking status prompts (adjusted odds ratio [aOR]: 0.94, CI: 0.92-0.96), and being abstinent (aOR: 0.96, CI: 0.93-0.99) on quit day. Two or more quit attempts were associated with increased response (aOR: 1.61, CI: 1.16-2.23) and abstinence (aOR: 1.91, CI: 1.25-2.92) rates on Day 7. In a first assessment of SmokeFreeTeen outcomes, we document high dropouts and low response and abstinence rates. SmokeFreeTeen produced abstinence rates lower than comparable text-messaging interventions targeting teens and young adults. Improving SmokeFreeTeen's reach, engagement, and effectiveness is needed.",2021,"Two or more quit attempts were associated with increased response (aOR: 1.61, CI: 1.16-2.23) and abstinence (aOR: 1.91, CI: 1.25-2.92) rates on Day 7.","['In a sample of teens (N = 2,685), aged 13-19, we examined demographics, smoking frequency, cigarettes smoked per day, prequit intervention time (i.e., maximum of 14 days of prequit day preparation), and number of quit attempts as correlates of response and abstinence rates among program initiators (i.e., participants who reached quit day but dropped out on or before intervention end) and completers (i.e., participants who reached quit day and completed the intervention']",['national text-messaging smoking cessation intervention'],"['Dropout, response, and abstinence rates', 'Dropout, response, and abstinence outcomes', 'abstinence rates', 'high dropouts and low response and abstinence rates']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0233535', 'cui_str': 'Butting'}, {'cui': 'C0439787', 'cui_str': 'Out'}, {'cui': 'C0444930', 'cui_str': 'End'}]","[{'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1692317', 'cui_str': 'Smoking cessation assistance'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",2685.0,0.0453291,"Two or more quit attempts were associated with increased response (aOR: 1.61, CI: 1.16-2.23) and abstinence (aOR: 1.91, CI: 1.25-2.92) rates on Day 7.","[{'ForeName': 'Charmaine', 'Initials': 'C', 'LastName': 'Chan', 'Affiliation': 'Intramural Research Program, National Institute on Minority Health and Health Disparities, Bethesda, MD, USA.'}, {'ForeName': 'Kristyn', 'Initials': 'K', 'LastName': 'Kamke', 'Affiliation': 'Intramural Research Program, National Institute on Minority Health and Health Disparities, Bethesda, MD, USA.'}, {'ForeName': 'Freda', 'Initials': 'F', 'LastName': 'Assuah', 'Affiliation': 'ICF International Rockville, MD, USA.'}, {'ForeName': 'Sherine', 'Initials': 'S', 'LastName': 'El-Toukhy', 'Affiliation': 'Intramural Research Program, National Institute on Minority Health and Health Disparities, Bethesda, MD, USA.'}]",Translational behavioral medicine,['10.1093/tbm/ibaa069'] 1087,33206059,Internet and Telerehabilitation-Delivered Management of Rotator Cuff-Related Shoulder Pain (INTEL Trial): Randomized Controlled Pilot and Feasibility Trial.,"BACKGROUND Rotator cuff-related shoulder pain (RCRSP) is a common and disabling musculoskeletal condition. Internet-based and telerehabilitation delivery of recommended care may improve access to care and improve adherence and outcomes. OBJECTIVE The primary aim of this pilot randomized controlled trial was to assess the feasibility of a 12-week internet-delivered intervention for RCRSP comparing advice only, recommended care, and recommended care with group-based telerehabilitation. METHODS Reporting was in accordance with the Consolidated Standards of Reporting Trials (CONSORT) checklist for pilot and feasibility trials. People with a primary complaint of RCRSP for 3 months or longer were identified via a paid Facebook strategy. Screening involved an online questionnaire followed by a 20-minute telehealth assessment. Participants were randomly allocated (via a Zelen design) to receive (1) advice only, (2) recommended care (internet-delivered evidence-based exercise and education), or (3) recommended care and telerehabilitation (including a weekly group teleconference session). Progression criteria for a full-scale trial included (1) recruitment of 20% or greater of eligible participants, (2) acceptable adherence (two or more of the three prescribed weekly sessions) among 70% or greater of participants, (3) 80% or greater retention of participants, (4) absence of intervention-related serious adverse events, and (5) 80% or greater response rates to questionnaires. Secondary clinical and patient knowledge outcomes were collected (via email or text) at baseline, six weeks, and 12 weeks (for clinical and patient knowledge), and within-group change was reported descriptively. RESULTS We enrolled 36 of 38 (95%) eligible participants and all participants were recruited within a 3-week period. Of the 36 participants, 12 participants were allocated to each of the three trial arms. The mean age of participants was between 51 and 56 years, and 83% (10/12) to 92% (11/12) were female. Retention at the 12-week endpoint was 94% (34/36) and response to email questionnaires at other time points was 83% or greater. We found acceptable adherence (defined as greater than 70% of participants performing exercise 2 or 3 times/week) in the recommended care group with telerehabilitation but not in the recommended care group without telerehabilitation. There was a total of 24 adverse events over 108 person-months of observation. All adverse events were mild or moderate (mainly muscle and shoulder symptoms), with the exception of one instance of elective surgery (unrelated to the person's shoulder condition). CONCLUSIONS Our prespecified success criteria were met or exceeded, but there was a gender imbalance toward women. It is feasible to progress to a fully powered trial, but strategies to address the gender imbalance need to be implemented. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry (ACTRN12620000248965); https://tinyurl.com/yy6eztf5.",2020,"Internet-based and telerehabilitation delivery of recommended care may improve access to care and improve adherence and outcomes. ","['People with a primary complaint of RCRSP for 3 months or longer were identified via a paid Facebook strategy', 'Reporting was in accordance with the Consolidated Standards of Reporting Trials (CONSORT) checklist for pilot and feasibility trials', 'We enrolled 36 of 38 (95%) eligible participants and all participants were recruited within a 3-week period', '36 participants, 12 participants', 'The mean age of participants was between 51 and 56 years, and 83% (10/12) to 92% (11/12) were female', 'Progression criteria for a full-scale trial included (1) recruitment of 20% or greater of eligible participants, (2) acceptable adherence (two or more of the three prescribed weekly sessions) among 70% or greater of participants, (3) 80% or greater retention of participants, (4) absence of intervention-related serious adverse events, and (5) 80% or greater response rates to questionnaires']","['Rotator cuff-related shoulder pain (RCRSP', 'receive (1) advice only, (2) recommended care (internet-delivered evidence-based exercise and education), or (3) recommended care and telerehabilitation (including a weekly group teleconference session', 'Internet and Telerehabilitation-Delivered Management of Rotator Cuff-Related Shoulder Pain (INTEL Trial']","['acceptable adherence', 'response to email questionnaires']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039450', 'cui_str': 'Teleconference'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",12.0,0.20208,"Internet-based and telerehabilitation delivery of recommended care may improve access to care and improve adherence and outcomes. ","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Malliaras', 'Affiliation': 'Physiotherapy Department, School of Primary and Allied Health Care, Faculty of Medicine Nursing and Health Science, Monash University, Melbourne, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Cridland', 'Affiliation': 'Physiotherapy Department, School of Primary and Allied Health Care, Faculty of Medicine Nursing and Health Science, Monash University, Melbourne, Australia.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Hopmans', 'Affiliation': 'Physiotherapy Department, School of Primary and Allied Health Care, Faculty of Medicine Nursing and Health Science, Monash University, Melbourne, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Ashton', 'Affiliation': 'Physiotherapy Department, School of Primary and Allied Health Care, Faculty of Medicine Nursing and Health Science, Monash University, Melbourne, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Littlewood', 'Affiliation': 'Faculty of Health, Psychology and Social Care, Manchester Metropolitan University, Manchester, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Page', 'Affiliation': 'Barwon Orthopaedic Research and Education, Barwon Health and School of Medicine, Deakin University, Geelong, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Harris', 'Affiliation': 'Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, Sydney, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Skouteris', 'Affiliation': 'Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Haines', 'Affiliation': 'School of Primary and Allied Health Care, Faculty of Medicine Nursing and Health Science, Monash University, Melbourne, Australia.'}]",JMIR mHealth and uHealth,['10.2196/24311'] 1088,33210113,Staged management of cardiac disease and concomitant early lung cancer: a 20-year single-center experience.,"OBJECTIVES The association of unstable heart disease and resectable lung cancer is rare. The impacts of staged management, cardiac surgery with cardiopulmonary bypass (CPB) versus angioplasty, on long-term survival and cancer recurrence remain debated. We report our experience using staged management. METHODS From 1997 to 2016, 107 patients were treated at the Quebec Heart and Lung Institute: 72 underwent cardiac surgery with CPB (group 1), 35 were treated with angioplasty (group 2), followed by oncological pulmonary resection. RESULTS Two postoperative deaths (3%) and 1 ischaemic heart complication (1%) were reported in group 1. One death (3%) was reported in group 2. Two-year overall survival was 82% (59/72) in group 1 and 80% (28/35) in group 2; 5-year overall survival was 62% (33/53) in group 1 and 63% (19/30) in group 2. Two-year disease-free survival in group 1 was 79% (57/72) and 77% (27/35) in group 2; 5-year disease-free survival was 58% (31/53) in group 1 and 60% (18/30) in group 2. The independent risk factors for death after thoracic surgery were transfusions (P = 0.004) and grade ≥3 complications (P = 0.034). Independent risk factors for recurrence included the cancer stage (P < 0.001) and, paradoxically, a shorter delay between cardiac and lung procedures (P = 0.031). CONCLUSIONS When a staged management remains feasible after cardiac procedure, oncological outcomes of patients with cardiopathy and lung cancer are satisfactory. CPB does not seem to be deleterious. The delay between procedures should intuitively be as small as possible but not at the expense of good recovery after the cardiac procedure.",2021,Two-year overall survival was 82% (59/72) in group 1 and 80% (28/35) in group 2; 5-year overall survival was 62% (33/53) in group 1 and 63% (19/30) in group 2.,"['From 1997 to 2016, 107 patients were treated at the Quebec Heart and Lung Institute: 72 underwent cardiac surgery with CPB (group 1', 'cardiac disease and concomitant early lung cancer', 'patients with cardiopathy and lung cancer']","['cardiac surgery with cardiopulmonary bypass (CPB) versus angioplasty', 'oncological pulmonary resection', 'angioplasty']","['postoperative deaths', '5-year overall survival', 'ischaemic heart complication', 'grade ≥3 complications', '5-year disease-free survival', 'overall survival']","[{'cui': 'C0730225', 'cui_str': '1997'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}]","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C0396565', 'cui_str': 'Lung excision'}]","[{'cui': 'C0277599', 'cui_str': 'Postoperative death'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",107.0,0.0677704,Two-year overall survival was 82% (59/72) in group 1 and 80% (28/35) in group 2; 5-year overall survival was 62% (33/53) in group 1 and 63% (19/30) in group 2.,"[{'ForeName': 'Jérémy', 'Initials': 'J', 'LastName': 'Tricard', 'Affiliation': 'Division of Thoracic Surgery, Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec City, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Milad', 'Affiliation': 'Division of Thoracic Surgery, Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec City, Canada.'}, {'ForeName': 'Anaëlle', 'Initials': 'A', 'LastName': 'Chermat', 'Affiliation': 'Thoracic and Cardiovascular Surgery Department, Limoges University Hospital Center, Limoges, France.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Simard', 'Affiliation': 'Division of Thoracic Surgery, Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec City, Canada.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Lacasse', 'Affiliation': 'Division of Thoracic Surgery, Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec City, Canada.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Dagenais', 'Affiliation': 'Cardiac Surgery Department, Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec City, Canada.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Conti', 'Affiliation': 'Division of Thoracic Surgery, Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec City, Canada.'}]",European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery,['10.1093/ejcts/ezaa360'] 1089,33210993,Impact of green tea intake on the pharmacokinetics of celiprolol in healthy subjects.,"OBJECTIVE To assess the effect of green tea intake on the pharmacokinetics of the β-blocker celiprolol. MATERIALS AND METHOD In an open-label crossover study, 3 healthy subjects were given water or a green tea beverage daily for 3 days. On day 4, each subject received a single oral dose of 200 mg celiprolol with water or green tea. Serum and urinary concentrations of celiprolol were measured for up to 24 hours. RESULTS Green tea intake decreased the area under the serum concentration-time curve and urinary excretion of celiprolol by 98.6 and 98.0%, respectively. CONCLUSION Green tea intake might have a negative impact on the clinical effectiveness of celiprolol.",2021,"RESULTS Green tea intake decreased the area under the serum concentration-time curve and urinary excretion of celiprolol by 98.6 and 98.0%, respectively. ","['healthy\xa0subjects', '3 healthy subjects']","['green tea intake', 'celiprolol with water or green tea']","['area under the serum concentration-time curve and urinary excretion of celiprolol', 'Serum and urinary concentrations of celiprolol']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1384640', 'cui_str': 'Green tea'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0055021', 'cui_str': 'Celiprolol'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0055021', 'cui_str': 'Celiprolol'}, {'cui': 'C0232827', 'cui_str': 'Urinary concentration'}]",3.0,0.0561195,"RESULTS Green tea intake decreased the area under the serum concentration-time curve and urinary excretion of celiprolol by 98.6 and 98.0%, respectively. ","[{'ForeName': 'Junichiro', 'Initials': 'J', 'LastName': 'Sonoda', 'Affiliation': ''}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ogata', 'Affiliation': ''}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Yoshikawa', 'Affiliation': ''}, {'ForeName': 'Keizo', 'Initials': 'K', 'LastName': 'Sato', 'Affiliation': ''}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Ikeda', 'Affiliation': ''}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Shimodozono', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP203795'] 1090,33207828,"Safety and Tolerability of SRX246, a Vasopressin 1a Antagonist, in Irritable Huntington's Disease Patients-A Randomized Phase 2 Clinical Trial.","SRX246 is a vasopressin (AVP) 1a receptor antagonist that crosses the blood-brain barrier. It reduced impulsive aggression, fear, depression and anxiety in animal models, blocked the actions of intranasal AVP on aggression/fear circuits in an experimental medicine fMRI study and demonstrated excellent safety in Phase 1 multiple-ascending dose clinical trials. The present study was a 3-arm, multicenter, randomized, placebo-controlled, double-blind, 12-week, dose escalation study of SRX246 in early symptomatic Huntington's disease (HD) patients with irritability. Our goal was to determine whether SRX246 was safe and well tolerated in these HD patients given its potential use for the treatment of problematic neuropsychiatric symptoms. Participants were randomized to receive placebo or to escalate to 120 mg twice daily or 160 mg twice daily doses of SRX246. Assessments included standard safety tests, the Unified Huntington's Disease Rating Scale (UHDRS), and exploratory measures of problem behaviors. The groups had comparable demographics, features of HD and baseline irritability. Eighty-two out of 106 subjects randomized completed the trial on their assigned dose of drug. One-sided exact-method confidence interval tests were used to reject the null hypothesis of inferior tolerability or safety for each dose group vs. placebo. Apathy and suicidality were not affected by SRX246. Most adverse events in the active arms were considered unlikely to be related to SRX246. The compound was safe and well tolerated in HD patients and can be moved forward as a candidate to treat irritability and aggression.",2020,"It reduced impulsive aggression, fear, depression and anxiety in animal models, blocked the actions of intranasal AVP on aggression/fear circuits in an experimental medicine fMRI study and demonstrated excellent safety in Phase 1 multiple-ascending dose clinical trials.","['Eighty-two out of 106 subjects', ""early symptomatic Huntington's disease (HD) patients with irritability"", ""Irritable Huntington's Disease Patients""]","['placebo or to escalate to 120 mg twice daily or 160 mg twice daily doses of SRX246', 'placebo', 'SRX246', 'SRX246, a Vasopressin 1a Antagonist']","[""standard safety tests, the Unified Huntington's Disease Rating Scale (UHDRS), and exploratory measures of problem behaviors"", 'Apathy and suicidality', 'Safety and Tolerability', 'safe and well tolerated', 'HD and baseline irritability', 'impulsive aggression, fear, depression and anxiety']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020179', 'cui_str': ""Huntington's chorea""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C3713502', 'cui_str': 'SRX246'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0020179', 'cui_str': ""Huntington's chorea""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0858853', 'cui_str': 'Impulsive aggression'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",106.0,0.171041,"It reduced impulsive aggression, fear, depression and anxiety in animal models, blocked the actions of intranasal AVP on aggression/fear circuits in an experimental medicine fMRI study and demonstrated excellent safety in Phase 1 multiple-ascending dose clinical trials.","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Brownstein', 'Affiliation': 'Azevan Pharmaceuticals, Inc., Bethlehem, PA 18015, USA.'}, {'ForeName': 'Neal G', 'Initials': 'NG', 'LastName': 'Simon', 'Affiliation': 'Azevan Pharmaceuticals, Inc., Bethlehem, PA 18015, USA.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Long', 'Affiliation': 'Department of Biostatistics, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Yankey', 'Affiliation': 'Department of Biostatistics, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Hilda T', 'Initials': 'HT', 'LastName': 'Maibach', 'Affiliation': 'Azevan Pharmaceuticals, Inc., Bethlehem, PA 18015, USA.'}, {'ForeName': 'Merit', 'Initials': 'M', 'LastName': 'Cudkowicz', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, MA 02114, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Coffey', 'Affiliation': 'Department of Biostatistics, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Robin A', 'Initials': 'RA', 'LastName': 'Conwit', 'Affiliation': 'National Institutes of Health, NINDS, Bethesda, MD 20852, USA.'}, {'ForeName': 'Codrin', 'Initials': 'C', 'LastName': 'Lungu', 'Affiliation': 'National Institutes of Health, NINDS, Bethesda, MD 20852, USA.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Anderson', 'Affiliation': 'Department of Neurology, Medstar Georgetown University Hospital, Washington, DC 20007, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Hersch', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, MA 02114, USA.'}, {'ForeName': 'Dixie J', 'Initials': 'DJ', 'LastName': 'Ecklund', 'Affiliation': 'Department of Biostatistics, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Eve M', 'Initials': 'EM', 'LastName': 'Damiano', 'Affiliation': 'Azevan Pharmaceuticals, Inc., Bethlehem, PA 18015, USA.'}, {'ForeName': 'Debra E', 'Initials': 'DE', 'LastName': 'Itzkowitz', 'Affiliation': 'Azevan Pharmaceuticals, Inc., Bethlehem, PA 18015, USA.'}, {'ForeName': 'Shifang', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Azevan Pharmaceuticals, Inc., Bethlehem, PA 18015, USA.'}, {'ForeName': 'Marianne K', 'Initials': 'MK', 'LastName': 'Chase', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, MA 02114, USA.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Shefner', 'Affiliation': 'Barrow Neurological Institute, Phoenix, AZ 85013, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McGarry', 'Affiliation': 'Department of Neurology, Cooper University Hospital, Camden, NJ 08103, USA.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Thornell', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, MA 02114, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Gladden', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, MA 02114, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Costigan', 'Affiliation': 'Department of Biostatistics, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Padraig', 'Initials': 'P', 'LastName': ""O'Suilleabhain"", 'Affiliation': 'Department of Neurology, UT Southwestern Medical Center, Dallas, TX 75390, USA.'}, {'ForeName': 'Frederick J', 'Initials': 'FJ', 'LastName': 'Marshall', 'Affiliation': 'Department of Neurology, University of Rochester Medical Center, Rochester, NY 14618, USA.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Chesire', 'Affiliation': 'Department of Neurology, University of Rochester Medical Center, Rochester, NY 14618, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Deritis', 'Affiliation': 'Department of Neurology, University of Rochester Medical Center, Rochester, NY 14618, USA.'}, {'ForeName': 'Jamie L', 'Initials': 'JL', 'LastName': 'Adams', 'Affiliation': 'Department of Neurology, University of Rochester Medical Center, Rochester, NY 14618, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hedera', 'Affiliation': 'Department of Neurology, Vanderbilt University, Nashville, TN 37212, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Lowen', 'Affiliation': 'Department of Neurology, Vanderbilt University, Nashville, TN 37212, USA.'}, {'ForeName': 'H Diana', 'Initials': 'HD', 'LastName': 'Rosas', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, MA 02114, USA.'}, {'ForeName': 'Amie L', 'Initials': 'AL', 'LastName': 'Hiller', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Quinn', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Kellie', 'Initials': 'K', 'LastName': 'Keith', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Duker', 'Affiliation': 'Department of Neurology, University of Cincinnati, Cincinnati, OH 45219, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Gruenwald', 'Affiliation': 'Department of Neurology, University of Cincinnati, Cincinnati, OH 45219, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Molloy', 'Affiliation': 'Department of Neurology, University of Cincinnati, Cincinnati, OH 45219, USA.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Jacob', 'Affiliation': 'Department of Neurology, University of Cincinnati, Cincinnati, OH 45219, USA.'}, {'ForeName': 'Stewart', 'Initials': 'S', 'LastName': 'Factor', 'Affiliation': 'Department of Neurology, Emory University, Atlanta, GA 30322, USA.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Sperin', 'Affiliation': 'Department of Neurology, Emory University, Atlanta, GA 30322, USA.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Bega', 'Affiliation': 'Department of Neurology, Northwestern University, Chicago, IL 60611, USA.'}, {'ForeName': 'Zsazsa R', 'Initials': 'ZR', 'LastName': 'Brown', 'Affiliation': 'Department of Neurology, Northwestern University, Chicago, IL 60611, USA.'}, {'ForeName': 'Lauren C', 'Initials': 'LC', 'LastName': 'Seeberger', 'Affiliation': 'Department of Neurology, University of Colorado Denver, Aurora, CO 80045, USA.'}, {'ForeName': 'Victor W', 'Initials': 'VW', 'LastName': 'Sung', 'Affiliation': 'Department of Neurology, The University of Alabama at Birmingham, Birmingham, AL 35233, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Benge', 'Affiliation': 'Department of Neurology, The University of Alabama at Birmingham, Birmingham, AL 35233, USA.'}, {'ForeName': 'Sandra K', 'Initials': 'SK', 'LastName': 'Kostyk', 'Affiliation': 'Department of Neurology, Ohio State University, Columbus, OH 43210, USA.'}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Daley', 'Affiliation': 'Department of Neurology, Ohio State University, Columbus, OH 43210, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Perlman', 'Affiliation': 'Department of Neurology, University of California Los Angeles, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Suski', 'Affiliation': 'Department of Neurology, University of Pittsburgh Medical Center, Pittsburgh, PA 15213, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Conlon', 'Affiliation': 'Department of Neurology, University of Pittsburgh Medical Center, Pittsburgh, PA 15213, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Barrett', 'Affiliation': 'Department of Neurology, Virginia Commonwealth University, Richmond, VA 23298, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Lowenhaupt', 'Affiliation': 'Department of Neurology, Virginia Commonwealth University, Richmond, VA 23298, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Quigg', 'Affiliation': 'Department of Neurology, Virginia Commonwealth University, Richmond, VA 23298, USA.'}, {'ForeName': 'Joel S', 'Initials': 'JS', 'LastName': 'Perlmutter', 'Affiliation': 'Department of Neurology, Washington University, Saint Louis, MO 63110, USA.'}, {'ForeName': 'Brenton A', 'Initials': 'BA', 'LastName': 'Wright', 'Affiliation': 'Department of Neurosciences, University of California San Diego, La Jolla, CA 92121, USA.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Most', 'Affiliation': 'Department of Neurology, Washington University, Saint Louis, MO 63110, USA.'}, {'ForeName': 'Guy J', 'Initials': 'GJ', 'LastName': 'Schwartz', 'Affiliation': 'Department of Neurology, Stony Brook University Hospital, Stony Brook, NY 11794, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Lamb', 'Affiliation': 'Department of Neurology, Stony Brook University Hospital, Stony Brook, NY 11794, USA.'}, {'ForeName': 'Rosalind S', 'Initials': 'RS', 'LastName': 'Chuang', 'Affiliation': 'Department of Neurology, Swedish Medical Center, Seattle, WA 98122, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Singer', 'Affiliation': 'Department of Neurology, University of Miami, Miami, FL 33136, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Marder', 'Affiliation': 'Department of Neurology, Columbia University, New York, NY 10032, USA.'}, {'ForeName': 'Joyce A', 'Initials': 'JA', 'LastName': 'Moran', 'Affiliation': 'Department of Neurology, Columbia University, New York, NY 10032, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Singleton', 'Affiliation': 'Clinical Neurosciences Center, University of Utah, Salt Lake City, UT 84132, USA.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Zorn', 'Affiliation': 'Clinical Neurosciences Center, University of Utah, Salt Lake City, UT 84132, USA.'}, {'ForeName': 'Paola V', 'Initials': 'PV', 'LastName': 'Wall', 'Affiliation': 'Clinical Neurosciences Center, University of Utah, Salt Lake City, UT 84132, USA.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Dubinsky', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, KS 66160, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Gray', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, KS 66160, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Drazinic', 'Affiliation': 'Department of Clinical Sciences, Florida State University, Tallahassee, FL 32306, USA.'}]",Journal of clinical medicine,['10.3390/jcm9113682'] 1091,33211881,Maternal Capabilities Are Associated with Child Caregiving Behaviors Among Women in Rural Zimbabwe.,"BACKGROUND Young children require high-quality care for healthy growth and development. We defined ""maternal capabilities"" as factors that influence mothers' caregiving ability (physical and mental health, social support, time, decision-making autonomy, gender norm attitudes, and mothering self-efficacy), and developed survey tools to assess them. OBJECTIVES We hypothesized that mothers with stronger capabilities during pregnancy would be more likely to practice improved care behaviors after their child was born. METHODS We assessed maternal capabilities among 4667 pregnant women newly enrolled in the Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial. Several improved child-care practices were promoted until 18 mo postpartum, the trial endpoint. Care practices were assessed by survey, direct observation, or transcription from health records during postpartum research visits. We used logistic regression to determine the predictive association between maternal capabilities during pregnancy and child-care practices. RESULTS Mothers with more egalitarian gender norm attitudes were more likely to have an institutional delivery [adjusted OR (AOR), 2.06; 95% CI, 1.57-2.69], initiate breastfeeding within 1 h of delivery (AOR, 1.38; 95% CI, 1.03-1.84), exclusively breastfeed (EBF) from birth to 3 mo (AOR, 2.55; 95% CI, 1.95-3.35) and 3-6 mo (AOR, 1.75; 95% CI, 1.36-2.25), and, among households randomized to receive extra modules on sanitation and hygiene, have soap and water at a handwashing station (AOR, 1.76; 95% CI, 1.29-2.39). Mothers experiencing time stress were less likely to EBF from birth to 3 mo (AOR, 0.79; 95% CI, 0.66-0.93). Greater social support was associated with institutional delivery (AOR, 1.53; 95% CI, 1.37-1.98) and, among mothers randomized to receive extra complementary feeding modules, feeding children a minimally diverse diet (AOR, 1.18; 95% CI, 1.01-1.37). Depressed mothers were 37% and 33%, respectively, less likely to have an institutional delivery (AOR, 0.63; 95% CI, 0.44-0.88) and a fully immunized child (AOR, 0.67; 95% CI, 0.50-0.90). CONCLUSIONS Interventions to reduce maternal depression, time stress, inadequate social support, and inequitable gender norms may improve maternal child caregiving.",2021,"Greater social support was associated with institutional delivery (AOR, 1.53; 95% CI, 1.37-1.98) and, among mothers randomized to receive extra complementary feeding modules, feeding children a minimally diverse diet (AOR, 1.18; 95% CI, 1.01-1.37).","['Women in Rural Zimbabwe', '4667 pregnant women newly enrolled in the Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial']",[],"['Mothers experiencing time stress', 'maternal depression, time stress, inadequate social support', 'care behaviors', 'Greater social support', 'initiate breastfeeding within 1 h of delivery']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0043476', 'cui_str': 'Zimbabwe'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0021279', 'cui_str': 'Infant nutrition'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C2364105', 'cui_str': 'Inadequate social support'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]",4667.0,0.142025,"Greater social support was associated with institutional delivery (AOR, 1.53; 95% CI, 1.37-1.98) and, among mothers randomized to receive extra complementary feeding modules, feeding children a minimally diverse diet (AOR, 1.18; 95% CI, 1.01-1.37).","[{'ForeName': 'Cynthia R', 'Initials': 'CR', 'LastName': 'Matare', 'Affiliation': 'Program in International Nutrition, Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Mduduzi N N', 'Initials': 'MNN', 'LastName': 'Mbuya', 'Affiliation': 'Program in International Nutrition, Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Dickin', 'Affiliation': 'Program in International Nutrition, Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Constas', 'Affiliation': 'Charles H. Dyson School of Applied Economics and Management, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Gretel', 'Initials': 'G', 'LastName': 'Pelto', 'Affiliation': 'Program in International Nutrition, Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Chasekwa', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Jean H', 'Initials': 'JH', 'LastName': 'Humphrey', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Stoltzfus', 'Affiliation': 'Program in International Nutrition, Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of nutrition,['10.1093/jn/nxaa255'] 1092,33212440,Brief Online Cognitive Behavioural Intervention for Dysfunctional Worry Related to the COVID-19 Pandemic: A Randomised Controlled Trial.,"INTRODUCTION Worries about the immediate and long-term consequences of the COVID-19 pandemic may for some individuals develop into pervasive worry that is disproportionate in its intensity or duration and significantly interferes with everyday life. OBJECTIVE The aim of this study was to investigate if a brief self-guided, online psychological intervention can reduce the degree of dysfunctional worry related to the COVID-19 pandemic and associated symptoms. METHODS 670 adults from the Swedish general population reporting daily uncontrollable worry about CO-VID-19 and its possible consequences (e.g., illness, death, the economy, one's family) were randomised (1:1 ratio) to a 3-week self-guided, online cognitive behavioural intervention targeting dysfunctional COVID-19 worry and associated symptoms, or a waiting list of equal duration. The primary outcome measure was a COVID-19 adapted version of the Generalised Anxiety Disorder 7-item scale administered at baseline and weeks 1-3 (primary endpoint). Follow-up assessments were conducted 1 month after treatment completion. The trial was registered on ClinicalTrials.gov (NCT04341922) before inclusion of the first participant. RESULTS The main pre-specified intention-to-treat analysis indicated significant reductions in COVID-19-related worry for the intervention group compared to the waiting list (β = 1.14, Z = 9.27, p < 0.001), corresponding to a medium effect size (bootstrapped d = 0.74 [95% CI: 0.58-0.90]). Improvements were also seen on all secondary measures, including mood, daily functioning, insomnia, and intolerance of uncertainty. Participant satisfaction was high. No serious adverse events were recorded. CONCLUSIONS A brief digital and easily scalable self-guided psychological intervention can significantly reduce dysfunctional worry and associated behavioural symptoms related to the COVID-19 pandemic.",2021,"CONCLUSIONS A brief digital and easily scalable self-guided psychological intervention can significantly reduce dysfunctional worry and associated behavioural symptoms related to the COVID-19 pandemic.","[""670 adults from the Swedish general population reporting daily uncontrollable worry about CO-VID-19 and its possible consequences (e.g., illness, death, the economy, one's family"", 'Dysfunctional Worry Related to the COVID-19 Pandemic']","['Brief Online Cognitive Behavioural Intervention', 'self-guided, online psychological intervention', '3-week self-guided, online cognitive behavioural intervention targeting dysfunctional COVID-19 worry and associated symptoms, or a waiting list of equal duration']","['dysfunctional worry and associated behavioural symptoms', 'serious adverse events', 'mood, daily functioning, insomnia, and intolerance of uncertainty', 'COVID-19-related worry', 'COVID-19 adapted version of the Generalised Anxiety Disorder 7-item scale']","[{'cui': 'C4517853', 'cui_str': '670'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]","[{'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",670.0,0.126312,"CONCLUSIONS A brief digital and easily scalable self-guided psychological intervention can significantly reduce dysfunctional worry and associated behavioural symptoms related to the COVID-19 pandemic.","[{'ForeName': 'Tove', 'Initials': 'T', 'LastName': 'Wahlund', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden, tove.wahlund@ki.se.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mataix-Cols', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Klara', 'Initials': 'K', 'LastName': 'Olofsdotter Lauri', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Elles', 'Initials': 'E', 'LastName': 'de Schipper', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Brjánn', 'Initials': 'B', 'LastName': 'Ljótsson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Aspvall', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Andersson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}]",Psychotherapy and psychosomatics,['10.1159/000512843'] 1093,33212488,Modest efficacy of nivolumab plus ipilimumab in patients with papillary renal cell carcinoma.,"PURPOSE Combined immunotherapy of nivolumab plus ipilimumab for intermediate- and poor-risk metastatic clear cell renal cell carcinoma showed prolonged progression-free survival and high objective response rate in a randomized phase III clinical trial. However, the efficacy of this treatment for papillary renal cell carcinoma remains unclear. In the present study, we analysed the efficacy of nivolumab plus ipilimumab therapy for papillary renal cell carcinoma compared with that for clear cell renal cell carcinoma. MATERIALS AND METHODS This is a retrospective study of 30 patients with metastatic renal cell carcinoma who received nivolumab and ipilimumab as first-line therapy between December 2015 and May 2020. The objective response rate, progression-free survival and toxicity were compared between the two groups (clear cell renal cell carcinoma and papillary renal cell carcinoma). RESULTS Out of 30 patients, 7 and 23 were diagnosed with papillary renal cell carcinoma and clear cell renal cell carcinoma, respectively. With a median follow-up of 7.2 months, the median progression-free survival was significantly shorter in papillary renal cell carcinoma than in clear cell renal cell carcinoma (2.4 vs. 28.1 months, P = 0.014). Of the seven patients with papillary renal cell carcinoma, one had partial response, one had stable disease and five had progressive disease, resulting in an objective response rate of 14.2%, which was lower compared to that of clear cell renal cell carcinoma (14.2 vs. 52.1%, P = 0.06). Discontinuation due to toxicity was not observed with papillary renal cell carcinoma, meanwhile 60.8% of patient with clear cell renal cell carcinoma discontinued treatment due to toxicity. CONCLUSION Nivolumab plus ipilimumab had modest efficacy for papillary renal cell carcinoma compared with that for clear cell renal cell carcinoma. Nivolumab plus ipilimumab remains an option for a limited number of patients with intermediate- or poor-risk papillary renal cell carcinoma.",2021,"The objective response rate, progression-free survival and toxicity were compared between the two groups (clear cell renal cell carcinoma and papillary renal cell carcinoma). ","['30 patients with metastatic renal cell carcinoma who received', 'patients with intermediate- or poor-risk papillary renal cell carcinoma', 'intermediate- and poor-risk metastatic clear cell renal cell carcinoma', '7 and 23 were diagnosed with papillary renal cell carcinoma and clear cell renal cell carcinoma, respectively', 'papillary renal cell carcinoma', 'seven patients with papillary renal cell carcinoma', 'as first-line therapy between December 2015 and May 2020', 'patients with papillary renal cell carcinoma']","['nivolumab plus ipilimumab therapy', 'Nivolumab plus ipilimumab', 'nivolumab plus ipilimumab', 'nivolumab and ipilimumab']","['objective response rate, progression-free survival and toxicity', 'clear cell renal cell carcinoma', 'median progression-free survival', 'progressive disease', 'toxicity', 'objective response rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721698', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1306837', 'cui_str': 'Papillary renal cell carcinoma'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0279702', 'cui_str': 'Clear cell carcinoma of kidney'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0279702', 'cui_str': 'Clear cell carcinoma of kidney'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",30.0,0.0233208,"The objective response rate, progression-free survival and toxicity were compared between the two groups (clear cell renal cell carcinoma and papillary renal cell carcinoma). ","[{'ForeName': 'Hidekazu', 'Initials': 'H', 'LastName': 'Tachibana', 'Affiliation': ""Department of Urology, Tokyo Women's Medical University Medical Center East, Tokyo, Japan.""}, {'ForeName': 'Tsunenori', 'Initials': 'T', 'LastName': 'Kondo', 'Affiliation': ""Department of Urology, Tokyo Women's Medical University Medical Center East, Tokyo, Japan.""}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Ishihara', 'Affiliation': ""Department of Urology, Tokyo Women's Medical University Tokyo, Tokyo, Japan.""}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Fukuda', 'Affiliation': ""Department of Urology, Tokyo Women's Medical University Tokyo, Tokyo, Japan.""}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': ""Department of Urology, Tokyo Women's Medical University Tokyo, Tokyo, Japan.""}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Takagi', 'Affiliation': ""Department of Urology, Tokyo Women's Medical University Tokyo, Tokyo, Japan.""}, {'ForeName': 'Junpei', 'Initials': 'J', 'LastName': 'Izuka', 'Affiliation': ""Department of Urology, Tokyo Women's Medical University Tokyo, Tokyo, Japan.""}, {'ForeName': 'Hirohito', 'Initials': 'H', 'LastName': 'Kobayashi', 'Affiliation': ""Department of Urology, Tokyo Women's Medical University Medical Center East, Tokyo, Japan.""}, {'ForeName': 'Kazunari', 'Initials': 'K', 'LastName': 'Tanabe', 'Affiliation': ""Department of Urology, Tokyo Women's Medical University Tokyo, Tokyo, Japan.""}]",Japanese journal of clinical oncology,['10.1093/jjco/hyaa229'] 1094,33215362,"A Randomized, Controlled Trial Comparing the Impact of a Low-Calorie Ketogenic vs a Standard Low-Calorie Diet on Fat-Free Mass in Patients Receiving an Elipse™ Intragastric Balloon Treatment.","BACKGROUND The Elipse™ intragastric balloon (EIGB) is a new swallowable balloon for weight loss (WL). Preserving metabolically active fat-free mass (FFM) and resting metabolic rate (RMR) during WL are crucial to maximize fat mass (FM) loss. After EIGB placement, a standard low-calorie diet (LCD) is generally prescribed. A low-calorie ketogenic diet (LCKD) has proven to be safe and effective in reducing FM while preserving FFM and RMR. OBJECTIVE To prospectively compare the effects on WL, FM, FFM, and RMR in two groups of patients who were randomized to two different diets: LCKD and a standard LCD after EIGB placement. METHODS WL, FM, FFM, and RMR were measured before EIGB and at 4 months in 48 patients who received either a LCKD (n = 24) or a standard LCD (n = 24). Compliance in following the prescribed diet was determined with food frequency questionnaires in all patients. The impact of LCKD and LCD on renal function was also evaluated. RESULTS The LCKD group showed a significantly lower decrease in FFM and RMR when compared with the LCD group (3.55 vs 14.3%, p < 0.001; 9.79 vs 11.4%, p < 0.001, respectively). FM decreased more significantly with LCKD compared to LCD (41.6 vs 33.1%, p = 0.0606). Compliance in following the prescribed diets, without negative impact on renal function, was found. CONCLUSION Based on our findings, despite the small sample size, we were able to support the hypothesis that LCKD is associated with an increased FM loss while reducing the FFM loss and the RMR, without interfering with renal function after EIGB.",2021,"The LCKD group showed a significantly lower decrease in FFM and RMR when compared with the LCD group (3.55 vs 14.3%, p < 0.001; 9.79 vs 11.4%, p < 0.001, respectively).","['two groups of patients who were randomized to two different diets: LCKD and a standard LCD after EIGB placement', 'Patients Receiving an Elipse™ Intragastric Balloon Treatment', '48 patients who received either a']","['LCKD and LCD', 'LCD', 'LCKD', 'low-calorie ketogenic diet (LCKD', 'standard LCD', 'standard low-calorie diet (LCD', 'Low-Calorie Ketogenic vs a Standard Low-Calorie Diet', 'Elipse™ intragastric balloon (EIGB']","['FM', 'Fat-Free Mass', 'FM loss', 'FFM and RMR', 'FM, FFM, and RMR', 'renal function', 'Preserving metabolically active fat-free mass (FFM) and resting metabolic rate (RMR']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0205177', 'cui_str': 'Active'}]",48.0,0.048542,"The LCKD group showed a significantly lower decrease in FFM and RMR when compared with the LCD group (3.55 vs 14.3%, p < 0.001; 9.79 vs 11.4%, p < 0.001, respectively).","[{'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Schiavo', 'Affiliation': 'Department of Medicine, Surgery, and Dentistry, ""Scuola Medica Salernitana"", University of Salerno, Fisciano, SA, Italy. lschiavo@unisa.it.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'De Stefano', 'Affiliation': 'Med.Ita Advanced Biomedical Solutions, Naples, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Persico', 'Affiliation': 'Unit of General and Specialistic Surgery, A.O.R.N. dei Colli Ospedali Monaldi-Cotugno-CTO, Naples, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Gargiulo', 'Affiliation': 'General Surgery Unit, Santa Maria La Bruna Clinic, Torre del Greco, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Di Spirito', 'Affiliation': 'Department of Medicine, Surgery, and Dentistry, ""Scuola Medica Salernitana"", University of Salerno, Fisciano, SA, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Griguolo', 'Affiliation': 'Department of Medicine, Surgery, and Dentistry, ""Scuola Medica Salernitana"", University of Salerno, Fisciano, SA, Italy.'}, {'ForeName': 'Niccolò', 'Initials': 'N', 'LastName': 'Petrucciani', 'Affiliation': 'Digestive Unit, Archet 2 Hospital, University Hospital of Nice, F-06202, Nice, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Fontas', 'Affiliation': 'Direction de la Recherche Clinique, University Hospital, Nice, France.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Iannelli', 'Affiliation': 'Digestive Unit, Archet 2 Hospital, University Hospital of Nice, F-06202, Nice, France.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Pilone', 'Affiliation': 'Department of Medicine, Surgery, and Dentistry, ""Scuola Medica Salernitana"", University of Salerno, Fisciano, SA, Italy.'}]",Obesity surgery,['10.1007/s11695-020-05133-8'] 1095,33221874,Heart transplant outcomes in patients with mechanical circulatory support: cold storage versus normothermic perfusion organ preservation.,"OBJECTIVES Patients with mechanical circulatory support bridged to a heart transplant (HTx) are at higher risk of postoperative graft dysfunction. In this subset, a mode of graft preservation that shortens graft ischaemia should be beneficial. METHODS The outcomes of 38 patients on mechanical circulatory support (extracorporeal life support, left ventricular assist device and biventricular assist device) who received a HTx between 2015 and 2020 were analysed according to the method of graft preservation: cold storage (CS) group, 24 (63%) or ex vivo perfusion (EVP) group, 14 (37%). RESULTS The median age was 57 (range 30-73) vs 64 (35-75) years (P = 0.10); 88% were men (P = 0.28); extracorporeal life support was more frequent in the CS group (54% vs 36%; P = 0.27) versus left ventricular and biventricular assist devices in the EVP group (46% vs 64%; P = 0.27). Clamping time was shorter in the EVP group (P < 0.001) and ischaemic time >4 h was higher in the CS group (P = 0.01). Thirty-day mortality was 13% (0-27%) in the CS group and 0% (P = 0.28) in the EVP group. A significantly lower primary graft failure [7% (0-23%) vs 42% (20-63%); P = 0.03] was observed in the EVP group. Survival at 1 year was 79 ± 8% (63-95%) in the CS group and 84 ± 10% (64-104%) in the EVP group (P = 0.95). CONCLUSIONS Our results support the use of ex vivo graft perfusion in patients on mechanical circulatory support as a bridge to a HTx. This technique, by shortening graft ischaemic time, seems to improve post-HTx outcomes.",2021,Clamping time was shorter in the EVP group (P < 0.001) and ischaemic time >4 h was higher in the CS group (P = 0.01).,"['38 patients on mechanical circulatory support (extracorporeal life support, left ventricular assist device and biventricular assist device) who received a HTx between 2015 and 2020 were analysed according to the method of graft preservation: cold storage (CS) group, 24 (63%) or', 'patients with mechanical circulatory support', 'Patients with mechanical circulatory support bridged to a heart transplant (HTx']",['ex vivo perfusion (EVP'],"['extracorporeal life support', 'Clamping time', 'ischaemic time >4\u2009h', 'primary graft failure', 'left ventricular and biventricular assist devices', 'Thirty-day mortality', 'Survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0179322', 'cui_str': 'Biventricular assist device'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0010405', 'cui_str': 'Cryopreservation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}]","[{'cui': 'C0031001', 'cui_str': 'Perfusion'}]","[{'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0301952', 'cui_str': 'Primary graft failure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0179322', 'cui_str': 'Biventricular assist device'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.0802508,Clamping time was shorter in the EVP group (P < 0.001) and ischaemic time >4 h was higher in the CS group (P = 0.01).,"[{'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Sponga', 'Affiliation': 'Cardiothoracic Department, University Hospital of Udine, Udine, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Benedetti', 'Affiliation': 'Cardiothoracic Department, University Hospital of Udine, Udine, Italy.'}, {'ForeName': 'Nunzio Davide', 'Initials': 'ND', 'LastName': 'de Manna', 'Affiliation': 'Cardiothoracic Department, University Hospital of Udine, Udine, Italy.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Ferrara', 'Affiliation': 'Cardiothoracic Department, University Hospital of Udine, Udine, Italy.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Vendramin', 'Affiliation': 'Cardiothoracic Department, University Hospital of Udine, Udine, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Lechiancole', 'Affiliation': 'Cardiothoracic Department, University Hospital of Udine, Udine, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Maiani', 'Affiliation': 'Cardiothoracic Department, University Hospital of Udine, Udine, Italy.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Nalon', 'Affiliation': 'Cardiothoracic Department, University Hospital of Udine, Udine, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Nalli', 'Affiliation': 'Cardiothoracic Department, University Hospital of Udine, Udine, Italy.'}, {'ForeName': 'Concetta', 'Initials': 'C', 'LastName': 'Di Nora', 'Affiliation': 'Cardiothoracic Department, University Hospital of Udine, Udine, Italy.'}, {'ForeName': 'Uberto', 'Initials': 'U', 'LastName': 'Bortolotti', 'Affiliation': 'Cardiothoracic Department, University Hospital of Udine, Udine, Italy.'}, {'ForeName': 'Ugolino', 'Initials': 'U', 'LastName': 'Livi', 'Affiliation': 'Cardiothoracic Department, University Hospital of Udine, Udine, Italy.'}]",Interactive cardiovascular and thoracic surgery,['10.1093/icvts/ivaa280'] 1096,33221910,Randomized controlled trial of an integrated approach to treating insomnia and improving the use of positive airway pressure therapy in veterans with comorbid insomnia disorder and obstructive sleep apnea.,"STUDY OBJECTIVES Cognitive behavioral therapy for insomnia (CBTI) for comorbid insomnia and obstructive sleep apnea (OSA) has had mixed results. We integrated CBTI with a positive airway pressure (PAP) adherence program and tested effects on sleep and PAP use. METHODS 125 veterans (mean age 63.2, 96% men, 39% non-Hispanic white, 26% black/African American, 18% Hispanic/Latino) with comorbid insomnia and newly-diagnosed OSA (apnea-hypopnea index ≥ 15) were randomized to 5-weekly sessions integrating CBTI with a PAP adherence program provided by a ""sleep coach"" (with behavioral sleep medicine supervision), or 5-weekly sleep education control sessions. Participants and assessment staff were blinded to group assignment. Outcomes (baseline, 3 and 6 months) included Pittsburgh Sleep Quality Index (PSQI), 7-day sleep diary (sleep onset latency [SOL-D], wake after sleep onset [WASO-D], sleep efficiency [SE-D]), 7-day actigraphy (SE-A), and objective PAP use (hours/night and nights ≥ 4 h). Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS), and Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10) were also collected. RESULTS Compared to controls, intervention participants showed greater improvement (baseline to 3 and 6 months, respectively) in PSQI (-3.2 and -1.7), SOL-D (-16.2 and -15.5 minutes), SE-D (10.5% and 8.5%), SE-A (4.4% and 2.6%) and more 90-day PAP use (1.3 and 0.9 more hours/night, 17.4 and 11.3 more nights PAP ≥ 4 h). 90-day PAP use at 3 months was 3.2 and 1.9 h/night in intervention versus controls. Intervention participants also had greater improvements in ISI, ESS, and FOSQ-10 (all p < 0.05). CONCLUSIONS An intervention integrating CBTI with a PAP adherence program delivered by a supervised sleep coach improved sleep and PAP use in adults with comorbid insomnia and OSA. TRIAL REGISTRATION ClinicalTrials.govStudy name: Novel Treatment of Comorbid Insomnia and Sleep Apnea in Older VeteransURL: https://clinicaltrials.gov/ct2/results?cond=&term=NCT02027558&cntry=&state=&city=&dist=Registration: NCT02027558.",2021,"Compared to controls, intervention participants showed greater improvement (baseline to 3- and 6-months, respectively) in PSQI (-3.2 and -1.7), SOL-D (-16.2 and -15.5 minutes), SE-D (10.5% and 8.5%), SE-A (4.4% and 2.6%) and more 90-day PAP use (1.3 and 0.9 more hours/night, 17.4 and 11.3 more nights PAP≥4 hours).","['insomnia (CBTI) for comorbid insomnia and obstructive sleep apnea (OSA', '125 veterans (mean age 63.2, 96% men, 39% non-Hispanic White, 26% Black/African American, 18% Hispanic/Latino) with comorbid insomnia and newly-diagnosed OSA (apnea-hypopnea index≥15', 'adults with comorbid insomnia and OSA', 'Veterans with Comorbid Insomnia Disorder and Obstructive Sleep Apnea']","['5-weekly sessions integrating CBTI with a PAP adherence program provided by a ""sleep coach"" (with behavioral sleep medicine supervision), or 5-weekly sleep education control sessions', 'supervised sleep coach', 'Cognitive behavioral therapy', 'Positive Airway Pressure Therapy']","['SE-D', 'PSQI', 'Pittsburgh Sleep Quality Index (PSQI), 7-day sleep diary (sleep onset latency [SOL-D], wake after sleep onset [WASO-D], sleep efficiency [SE-D]), 7-day actigraphy (SE-A), and objective PAP use (hours/night and nights≥4 hours', '90-day PAP', 'Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS) and Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10', 'ISI, ESS and FOSQ-10', '90-day PAP use', 'SOL-D']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4304028', 'cui_str': 'Sleep medicine specialist'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0206630', 'cui_str': 'Endometrial stromal sarcoma'}]",,0.0172234,"Compared to controls, intervention participants showed greater improvement (baseline to 3- and 6-months, respectively) in PSQI (-3.2 and -1.7), SOL-D (-16.2 and -15.5 minutes), SE-D (10.5% and 8.5%), SE-A (4.4% and 2.6%) and more 90-day PAP use (1.3 and 0.9 more hours/night, 17.4 and 11.3 more nights PAP≥4 hours).","[{'ForeName': 'Cathy A', 'Initials': 'CA', 'LastName': 'Alessi', 'Affiliation': 'Geriatric Research, Education and Clinical Center (GRECC), VA Greater Los Angeles Healthcare System, Los Angeles, CA.'}, {'ForeName': 'Constance H', 'Initials': 'CH', 'LastName': 'Fung', 'Affiliation': 'Geriatric Research, Education and Clinical Center (GRECC), VA Greater Los Angeles Healthcare System, Los Angeles, CA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Dzierzewski', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Lavinia', 'Initials': 'L', 'LastName': 'Fiorentino', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego, CA.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Stepnowsky', 'Affiliation': 'Department of Medicine, University of California, San Diego, San Diego, CA.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Rodriguez Tapia', 'Affiliation': 'Department of Medicine, Pontificia Universidad Catolica de Chile, Santiago, Chile.'}, {'ForeName': 'Yeonsu', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Geriatric Research, Education and Clinical Center (GRECC), VA Greater Los Angeles Healthcare System, Los Angeles, CA.'}, {'ForeName': 'Michelle R', 'Initials': 'MR', 'LastName': 'Zeidler', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Josephson', 'Affiliation': 'Geriatric Research, Education and Clinical Center (GRECC), VA Greater Los Angeles Healthcare System, Los Angeles, CA.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Mitchell', 'Affiliation': 'Geriatric Research, Education and Clinical Center (GRECC), VA Greater Los Angeles Healthcare System, Los Angeles, CA.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Jouldjian', 'Affiliation': 'Geriatric Research, Education and Clinical Center (GRECC), VA Greater Los Angeles Healthcare System, Los Angeles, CA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Martin', 'Affiliation': 'Geriatric Research, Education and Clinical Center (GRECC), VA Greater Los Angeles Healthcare System, Los Angeles, CA.'}]",Sleep,['10.1093/sleep/zsaa235'] 1097,32692284,Prediction of Minor Salivary Gland Carcinoma: A Novel Nomogram and Risk Classification System for Overall Survival and Cancer-Specific Survival.,"OBJECTIVE Minor salivary gland carcinoma (MiSGC) is rare, and the understanding of this disease is insufficient. This study aimed to identify independent risk factors and develop a nomogram for evaluating the overall survival (OS) and cancer-specific survival (CSS) of patients with MiSGC. STUDY DESIGN Retrospective cohort study. SETTING SEER database (Surveillance, Epidemiology, and End Results). SUBJECTS AND METHODS We collected data from patients diagnosed with MiSGC between 2004 and 2015 from the SEER database. According to patient registration, all patients were randomly allocated to training sets and validation sets (2:1). Then, Kaplan-Meier product limit curves and Cox proportional hazard regressions were performed to estimate the prognostic effect of variables. Nomograms based on Cox proportional hazard regressions were established to estimate 3- and 5-year OS and CSS. Finally, the nomogram was developed by the training set, and validation was performed with the concordance index, calibration curves, and decision curve analyses. RESULTS In total, 1787 MiSGC cases were registered in SEER. The concordance index for internal validation of OS and CSS prediction was 0.842 and 0.816; that of external validation was 0.871 and 0.831. The calibration plots showed good consistency between nomogram prediction and actual survival. The decision curve analysis showed substantial net benefits of the new predictive model. CONCLUSIONS We constructed nomograms and a corresponding risk classification system predicting the OS and CSS of patients with MiSGC. These tools can generate simple-to-use clinical risk grouping and determine the relationship between adjuvant therapy and active surveillance.",2021,The concordance index for internal validation of OS and CSS prediction was 0.842 and 0.816; that of external validation was 0.871 and 0.831.,"['patients with MiSGC', 'Minor Salivary Gland Carcinoma', 'We collected data from patients diagnosed with MiSGC between 2004 and 2015 from the SEER database']",[],"['concordance index for internal validation of OS and CSS prediction', 'overall survival (OS) and cancer-specific survival (CSS', 'Overall Survival and Cancer-Specific Survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036099', 'cui_str': 'Minor salivary gland structure'}, {'cui': 'C0007097', 'cui_str': 'Carcinoma'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]",[],"[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",,0.0427726,The concordance index for internal validation of OS and CSS prediction was 0.842 and 0.816; that of external validation was 0.871 and 0.831.,"[{'ForeName': 'Ling-Feng', 'Initials': 'LF', 'LastName': 'Lan', 'Affiliation': 'Department of Otolaryngology, the 903(rd) Hospital of PLA, Hangzhou, China.'}, {'ForeName': 'Chen-Kai', 'Initials': 'CK', 'LastName': 'Gao', 'Affiliation': 'Department of Otolaryngology, the 903(rd) Hospital of PLA, Hangzhou, China.'}, {'ForeName': 'Chao-Wu', 'Initials': 'CW', 'LastName': 'Ma', 'Affiliation': 'Department of Otolaryngology, the 903(rd) Hospital of PLA, Hangzhou, China.'}]",Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery,['10.1177/0194599820938323'] 1098,32692356,The Moderating Effects of Social Support and Stress on Physical Activity in African American Women.,"BACKGROUND African American women participate in less physical activity (PA), have higher rates of chronic disease, and report higher perceived stress relative to other race and sex demographic groups. PURPOSE Based on the stress-buffering hypothesis, this study tested the hypothesis that social support would buffer the negative effects of perceived stress on moderate-to-vigorous PA (MVPA) under high, but not low, perceived stress. METHODS Participants were 143 African American women (mean [M] age = 43.94, standard deviation [SD] = 8.62; M body mass index = 37.94, SD = 8.11) enrolled in the Families Improving Together (FIT) for Weight Loss Trial. Average daily minutes of MVPA were obtained via 7 day accelerometer estimates at baseline and 8 and 16 weeks. RESULTS A multilevel growth model demonstrated a significant three-way interaction between stress, social support, and time (B = -0.31, standard error [SE] = 0.14, p = .03). Simple slopes analyses revealed that, at baseline, among participants with high social support (+1 SD), stress was positively associated with greater MVPA (B = 0.49, SE = 0.18, p = .008), whereas among participants with low social support (-1 SD), stress was not significantly associated with MVPA (B = -0.04, SE = 0.14, p = .81). However, at 8 and 16 weeks, stress was not significantly associated with MVPA for either high or low support groups. CONCLUSIONS Findings highlight the importance of integrating constructs of stress and social support into future physical activity intervention programs for African American women and the need to evaluate changes in stress and social support longitudinally.",2021,"However, at 8 and 16 weeks, stress was not significantly associated with MVPA for either high or low support groups. ","['African American women participate in less physical activity (PA', 'African American Women', 'African American women', 'Participants were 143 African American women (mean [M] age = 43.94, standard deviation [SD] = 8.62; M body mass index = 37.94, SD = 8.11) enrolled in the Families Improving Together (FIT) for Weight Loss Trial']",['Social Support and Stress'],"['Average daily minutes of MVPA', 'Physical Activity']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",143.0,0.020482,"However, at 8 and 16 weeks, stress was not significantly associated with MVPA for either high or low support groups. ","[{'ForeName': 'Asia', 'Initials': 'A', 'LastName': 'Brown', 'Affiliation': 'Department of Psychology, Barnwell College, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Dawn K', 'Initials': 'DK', 'LastName': 'Wilson', 'Affiliation': 'Department of Psychology, Barnwell College, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Sweeney', 'Affiliation': 'Department of Psychology, Barnwell College, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'M Lee', 'Initials': 'ML', 'LastName': 'Van Horn', 'Affiliation': 'Department of Educational Psychology, University of New Mexico, Albuquerque, NM, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa051'] 1099,32715609,Safety and target engagement profile of two oxaloacetate doses in Alzheimer's patients.,"INTRODUCTION Brain bioenergetics are defective in Alzheimer's disease (AD). Preclinical studies find oxaloacetate (OAA) enhances bioenergetics, but human safety and target engagement data are lacking. METHODS We orally administered 500 or 1000 mg OAA, twice daily for 1 month, to AD participants (n = 15 each group) and monitored safety and tolerability. To assess brain metabolism engagement, we performed fluorodeoxyglucose positron emission tomography (FDG PET) and magnetic resonance spectroscopy before and after the intervention. We also assessed pharmacokinetics and cognitive performance. RESULTS Both doses were safe and tolerated. Compared to the lower dose, the higher dose benefited FDG PET glucose uptake across multiple brain regions (P < .05), and the higher dose increased parietal and frontoparietal glutathione (P < .05). We did not demonstrate consistent blood level changes and cognitive scores did not improve. CONCLUSIONS 1000 mg OAA, taken twice daily for 1 month, is safe in AD patients and engages brain energy metabolism.",2021,"Compared to the lower dose, the higher dose benefited FDG PET glucose uptake across multiple brain regions (P < .05), and the higher dose increased parietal and frontoparietal glutathione (P < .05).","[""Alzheimer's patients""]","['fluorodeoxyglucose positron emission tomography (FDG PET) and magnetic resonance spectroscopy', 'oxaloacetate (OAA']","['blood level changes and cognitive scores', 'parietal and frontoparietal glutathione', 'safety and tolerability', 'pharmacokinetics and cognitive performance', 'safe and tolerated', 'FDG PET glucose uptake across multiple brain regions']","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3641247', 'cui_str': 'FDG PET scan'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0029989', 'cui_str': 'Ketosuccinates'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C3641247', 'cui_str': 'FDG PET scan'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1273723', 'cui_str': 'Brain region'}]",,0.104164,"Compared to the lower dose, the higher dose benefited FDG PET glucose uptake across multiple brain regions (P < .05), and the higher dose increased parietal and frontoparietal glutathione (P < .05).","[{'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Vidoni', 'Affiliation': ""University of Kansas Alzheimer's Center, Fairway, Kansas, USA.""}, {'ForeName': 'In-Young', 'Initials': 'IY', 'LastName': 'Choi', 'Affiliation': ""University of Kansas Alzheimer's Center, Fairway, Kansas, USA.""}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Lee', 'Affiliation': ""University of Kansas Alzheimer's Center, Fairway, Kansas, USA.""}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Reed', 'Affiliation': 'Department of Pharmacology and Toxicology, Kansas University Medical Center, Kansas City, Kansas, USA.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmacology and Toxicology, Kansas University Medical Center, Kansas City, Kansas, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Pleen', 'Affiliation': ""University of Kansas Alzheimer's Center, Fairway, Kansas, USA.""}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Mahnken', 'Affiliation': ""University of Kansas Alzheimer's Center, Fairway, Kansas, USA.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Clutton', 'Affiliation': ""University of Kansas Alzheimer's Center, Fairway, Kansas, USA.""}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Becker', 'Affiliation': ""University of Kansas Alzheimer's Center, Fairway, Kansas, USA.""}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Sherry', 'Affiliation': ""University of Kansas Alzheimer's Center, Fairway, Kansas, USA.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Bothwell', 'Affiliation': ""University of Kansas Alzheimer's Center, Fairway, Kansas, USA.""}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Anderson', 'Affiliation': ""University of Kansas Alzheimer's Center, Fairway, Kansas, USA.""}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Harris', 'Affiliation': 'Biochemistry and Molecular Biology, Kansas University Medical Center, Kansas City, Kansas, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Brooks', 'Affiliation': ""University of Kansas Alzheimer's Center, Fairway, Kansas, USA.""}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Wilkins', 'Affiliation': ""University of Kansas Alzheimer's Center, Fairway, Kansas, USA.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Mosconi', 'Affiliation': 'Department of Neurology, Weill Cornell Medical College, New York, New York, USA.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Burns', 'Affiliation': ""University of Kansas Alzheimer's Center, Fairway, Kansas, USA.""}, {'ForeName': 'Russell H', 'Initials': 'RH', 'LastName': 'Swerdlow', 'Affiliation': ""University of Kansas Alzheimer's Center, Fairway, Kansas, USA.""}]",Alzheimer's & dementia : the journal of the Alzheimer's Association,['10.1002/alz.12156'] 1100,32712103,Progression of Fatty Liver Disease in Children Receiving Standard of Care Lifestyle Advice.,"BACKGROUND & AIMS Nonalcoholic fatty liver disease (NAFLD) is the most common pediatric chronic liver disease. Little is known about outcomes in recognized youth. METHODS We compared paired liver biopsies from 122 of 139 children with NAFLD (74% male; 64% white; 71% Hispanic; mean age, 13 ± 3 years; age range, 8-17 years) who received placebo and standard of care lifestyle advice in 2 double-blind, randomized clinical trials within the nonalcoholic steatohepatitis (NASH) clinical research network from 2005 through 2015. We analyzed histologic changes with respect to baseline and longitudinal change in clinical variables using regression analysis. RESULTS At enrollment, 31% of the children had definite NASH, 34% had borderline zone 1 NASH, 13% had borderline zone 3 NASH, and 21% had fatty liver but not NASH. Over a mean period of 1.6 ± 0.4 years, borderline or definite NASH resolved in 29% of the children, whereas 18% of the children with fatty liver or borderline NASH developed definite NASH. Fibrosis improved in 34% of the children but worsened in 23%. Any progression to definite NASH and/or in fibrosis was associated with adolescent age, and higher waist circumference, levels of alanine or aspartate aminotransferase, total and low-density lipoprotein cholesterol at baseline (<0.05), and over follow-up time, with increasing level of alanine aminotransferase, hemoglobin A1C (P<.05), gamma-glutamyl transferase and development of type 2 diabetes (P<.01). Increasing level of gamma-glutamyl transferase was also associated with reduced odds of any improvement (P = .003). CONCLUSIONS One-third of children with NAFLD enrolled in placebo groups of clinical trials had histologic features of progression within 2 years, in association with increasing obesity and serum levels of aminotransferases and loss of glucose homeostasis.",2020,"Increasing level of gamma-glutamyl transferase also associated with reduced odds of any improvement (P=.003). ","['We compared paired liver biopsies from 122 of 139 children with NAFLD (74% male; 64% white; 71% Hispanic; mean age, 13±3 years; age range, 8-17 years) who received', 'Children Receiving Standard of Care Lifestyle Advice']","['placebo and standard of care lifestyle advice', 'placebo', 'NASH']","['Increasing level of gamma-glutamyl transferase', 'Fibrosis', 'borderline or definite NASH', 'level of gamma-glutamyl transferase and development of type 2 diabetes', 'obesity and serum levels of aminotransferases and loss of glucose homeostasis', 'NASH or fibrosis', 'waist circumference, levels of alanine or aspartate aminotransferase, total and low density lipoprotein cholesterol at baseline, increasing level of alanine aminotransferase, hemoglobin A1C (P<.05']","[{'cui': 'C0193388', 'cui_str': 'Biopsy of liver'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",139.0,0.180644,"Increasing level of gamma-glutamyl transferase also associated with reduced odds of any improvement (P=.003). ","[{'ForeName': 'Stavra A', 'Initials': 'SA', 'LastName': 'Xanthakos', 'Affiliation': ""Division of Gastroenterology, Hepatology and Nutrition, Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.""}, {'ForeName': 'Joel E', 'Initials': 'JE', 'LastName': 'Lavine', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Columbia Vagelos College of Physicians and Surgeons, New York, New York. Electronic address: jl3553@columbia.edu.'}, {'ForeName': 'Katherine P', 'Initials': 'KP', 'LastName': 'Yates', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Jeffrey B', 'Initials': 'JB', 'LastName': 'Schwimmer', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, University of California San Diego School of Medicine, La Jolla, California.'}, {'ForeName': 'Jean P', 'Initials': 'JP', 'LastName': 'Molleston', 'Affiliation': 'Division of Pediatric Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Indiana University School of Medicine/Riley Hospital for Children, Indianapolis, Indiana.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Rosenthal', 'Affiliation': ""Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, University of California, Benioff Children's Hospital, San Francisco, California.""}, {'ForeName': 'Karen F', 'Initials': 'KF', 'LastName': 'Murray', 'Affiliation': ""Pediatrics Institute, Cleveland Clinic Children's, Cleveland, Ohio.""}, {'ForeName': 'Miriam B', 'Initials': 'MB', 'LastName': 'Vos', 'Affiliation': ""Division of Pediatric Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, Georgia.""}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Jain', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, St. Louis University, St. Louis, Missouri.'}, {'ForeName': 'Ann O', 'Initials': 'AO', 'LastName': 'Scheimann', 'Affiliation': 'Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Tamir', 'Initials': 'T', 'LastName': 'Miloh', 'Affiliation': 'Miami Transplant Institute, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Fishbein', 'Affiliation': 'Department of Pediatrics, Feinberg Medical School of Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Behling', 'Affiliation': 'Department of Pathology, Sharp Memorial Hospital; Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, University of California, San Diego, California.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Brunt', 'Affiliation': 'Department of Pathology and Immunology, Washington University, St. Louis, Missouri.'}, {'ForeName': 'Arun J', 'Initials': 'AJ', 'LastName': 'Sanyal', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University School of Medicine, Richmond, Virginia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tonascia', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Gastroenterology,['10.1053/j.gastro.2020.07.034'] 1101,32712155,Comparative analysis of predictive values of the kinetics of 11 circulating miRNAs and of CA125 in ovarian cancer during first line treatment (a GINECO study).,"OBJECTIVE MicroRNAs (miRNAs) are promising biomarkers in ovarian cancer. Their kinetics during treatment might be useful for monitoring disease burden, and guiding treatments in patients treated with peri-operative chemotherapy and interval debulking surgery (IDS). METHODS Serial blood samples of patients enrolled in the randomized phase II CHIVA trial, comparing first line carboplatin-paclitaxel +/- nintedanib (NCT01583322) and IDS, were investigated to assess the kinetics of 11 relevant miRNAs. Their prognostic/predictive values regarding the likelihood of complete IDS, and the patient survival, were assessed and compared to those of CA125 kinetics. The selection of the miRNAs (miR-15b-5p, miR-16-5p, miR-20a-5p, miR-21-5p, miR-93-5p, miR-122-5p, miR-150-5p, miR-195-5p, miR-200b-3p, miR-148b-5p and miR-34a-5p) was based on the expression levels found with a large explorative panel, and on the literature data. RESULTS 756 serial blood samples from 119 patients were analyzed for a total of 8172 miRNA assays, and 1299 CA125 values. The longitudinal kinetics of the miRNA expressions were highly inconsistent, and were not related to CA125 dynamics. The miRNA changes during neoadjuvant treatment were not found associated with RECIST tumor response or IDS outcomes. Decreases of miR-34a-5p and miR-93-5p were associated with PFS benefit (p = .009) and OS benefits (p < .001), respectively, using univariate tests. CONCLUSIONS The longitudinal kinetics of miRNA expressions during neoadjuvant treatment in ovarian cancer patients were inconsistent, and were not found to be associated with tumor burden changes. Although some prognostic value could be discussed, no predictive value regarding tumor responses or IDS quality could be identified.",2020,"Decreases of miR-34a-5p and miR-93-5p were associated with PFS benefit (p = .009) and OS benefits (p < .001), respectively, using univariate tests. ","['756 serial blood samples from 119 patients were analyzed for a total of 8172 miRNA assays, and 1299 CA125 values', 'ovarian cancer patients', 'Serial blood samples of patients enrolled in the randomized phase II CHIVA trial, comparing first', 'patients treated with peri-operative chemotherapy and interval debulking surgery (IDS']",['line carboplatin-paclitaxel '],"['RECIST tumor response or IDS outcomes', 'OS benefits', 'patient survival']","[{'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0006610', 'cui_str': 'Cancer antigen 125'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",119.0,0.0509418,"Decreases of miR-34a-5p and miR-93-5p were associated with PFS benefit (p = .009) and OS benefits (p < .001), respectively, using univariate tests. ","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Robelin', 'Affiliation': ""EMR3738, Ciblage Thérapeutique en Oncologie, Faculté de Médecine et de Maïeutique Lyon-Sud Charles Mérieux, Université Claude Bernard Lyon 1, Oullins, France, Université de Lyon, Lyon, France; Service d'Oncologie Médicale, CITOHL, Centre Hospitalo-Universitaire Lyon-Sud, Institut de Cancérologie des Hospices Civils de Lyon (IC-HCL), Pierre-Bénite, France, GINECO, Paris, France. Electronic address: patrick.robelin@chu-lyon.fr.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Tod', 'Affiliation': 'EMR3738, Ciblage Thérapeutique en Oncologie, Faculté de Médecine et de Maïeutique Lyon-Sud Charles Mérieux, Université Claude Bernard Lyon 1, Oullins, France, Université de Lyon, Lyon, France; Pharmacie, Hôpital de la Croix Rousse, Hospices civils de Lyon, Lyon, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Colomban', 'Affiliation': 'EMR3738, Ciblage Thérapeutique en Oncologie, Faculté de Médecine et de Maïeutique Lyon-Sud Charles Mérieux, Université Claude Bernard Lyon 1, Oullins, France, Université de Lyon, Lyon, France.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Lachuer', 'Affiliation': 'ProfileXpert, SFR-Est, CNRS UMR-S3453, INSERM US7, Lyon, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Ray-Coquard', 'Affiliation': 'Centre Léon Bérard, Cancérologie médicale - 28 Prom. Léa et Napoléon Bullukian, 69008 Lyon Université Claude Bernard Lyon 1, GINECO, Paris, France.'}, {'ForeName': 'Gaëtan De', 'Initials': 'G', 'LastName': 'Rauglaudre', 'Affiliation': 'Institut Sainte-Catherine, Oncologie radiothérapie, 250 Chemin De Baigne Pieds Cs80005, 84918 Avignon, GINECO, Paris, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Joly', 'Affiliation': 'Centre François Baclesse, Oncologie Médicale, 13 Rue du Général Harris 14000 Caen, Université Unicaen, GINECO, Paris, France.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Chevalier-Place', 'Affiliation': 'Centre Oscar Lambret, Cancérologie gynécologique, 3 Frédéric COMBEMALE 59020 Lille, GINECO, Paris, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Combe', 'Affiliation': 'Hôpital Européen Georges Pompidou, Oncologie Médicale, 20 Rue Leblanc, 75015 Paris, GINECO, Paris, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Lortholary', 'Affiliation': 'Hôpital Privé du Confluent, Oncologie médicale, 4 rue Eric Tabarly 44200 Nantes, GINECO, Paris, France.'}, {'ForeName': 'Salima', 'Initials': 'S', 'LastName': 'Hamizi', 'Affiliation': 'Centre Hospitalier Lyon Sud, Oncologie médicale, 165 Chemin Du Grand Revoyet (CH LYON SUD), 69310 Pierre Benite, GINECO, Paris, France.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Raban', 'Affiliation': 'Hôpital de la Milétrie, Centre Hospitalier Universitaire de Poitiers, Oncologie médicale, 2 Rue De La Miletrie 86000 Poitiers, GINECO, Paris, France.'}, {'ForeName': 'Gwénaël', 'Initials': 'G', 'LastName': 'Ferron', 'Affiliation': 'Institut Claudius Regaud, Service de chirurgie oncologique, 1 avenue Irène Joliot-Curie, 31059 Toulouse CEDEX 09, GINECO, Paris, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Meunier', 'Affiliation': ""Centre Hospitalier Régional d'Orléans, Oncologie médicale, 14 Avenue De L'Hôpital, 45100 Orléans, GINECO, Paris, France.""}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Berton-Rigaud', 'Affiliation': 'ICO site René Gauducheau, Oncologie médicale, Boulevard Jacques Monod, 44800 Saint Herblain, GINECO, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Alexandre', 'Affiliation': 'Hôpital Cochin, Cancérologie oncologie, 27, Rue du Faubourg Saint Jacques, 75014 Paris, GINECO, Paris, France.'}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Kaminsky', 'Affiliation': 'Institut de cancérologie de lorraine, Alexis Vautrin, Oncologie médicale, 6 avenue de bourgogne 54500 Vandœuvre-lès-Nancy, GINECO, Paris, France.'}, {'ForeName': 'Coraline', 'Initials': 'C', 'LastName': 'Dubot', 'Affiliation': 'Centre RENE HUGUENIN INSTITUT CURIE, Oncologie médicale, 35 Rue Dailly, 92210 Saint Cloud, GINECO, Paris, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Leary', 'Affiliation': 'Institut Gustave Roussy, Département de médecine, 114 rue Edouard Vaillant 94805 VILLEJUIF, GINECO, Paris, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Malaurie', 'Affiliation': 'Centre Hospitalier Intercommunal de Créteil, Oncologie Médicale et Radiothérapie, 40 Avenue de Verdun, 94000 Créteil, GINECO, Paris, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'You', 'Affiliation': ""EMR3738, Ciblage Thérapeutique en Oncologie, Faculté de Médecine et de Maïeutique Lyon-Sud Charles Mérieux, Université Claude Bernard Lyon 1, Oullins, France, Université de Lyon, Lyon, France; Service d'Oncologie Médicale, CITOHL, Centre Hospitalo-Universitaire Lyon-Sud, Institut de Cancérologie des Hospices Civils de Lyon (IC-HCL), Pierre-Bénite, France, GINECO, Paris, France.""}]",Gynecologic oncology,['10.1016/j.ygyno.2020.07.021'] 1102,32719011,Effects on time to lapse of switching menthol smokers to non-menthol cigarettes prior to a cessation attempt: a pilot study.,"INTRODUCTION Menthol smokers (particularly African-Americans) have lower cessation success rates than non-menthol smokers. With bans being considered on characterising menthol flavour in cigarettes, data are needed regarding how switching to non-menthol cigarettes impacts cessation measures. METHODS In this randomised pilot study, African-American menthol cigarette smokers interested in quitting smoking either continued smoking menthol cigarettes (n=60) or switched to non-menthol cigarettes (n=62) for a 1-month period prior to a cessation attempt. The primary endpoint was time to smoking lapse (ie, time from quitting until any smoking). Additional endpoints included time to smoking relapse (ie, number of days from quitting until the first of seven consecutive smoking days) and difference between groups in subjective measures. RESULTS After attempting to quit, the non-menthol cigarette group had indications of delayed time to lapse (HR 0.82; 95% CI 0.55 to 1.22; p=0.33) and time to relapse (HR 0.67; 95% CI 0.42 to 1.06; p=0.09), although these were not statistically significant. Post hoc analyses suggest that observed differences were largely due to a smaller proportion of participants in the non-menthol group relapsing within the first day of quitting (21% vs 40%; p=0.05). Values of other measures assessed postcessation were largely similar between groups. CONCLUSIONS These data suggest that among African-American smokers, a menthol cigarette ban would not undermine short-term cessation measures and may result in some benefits. Future research is needed to assess longer term cessation rates and to identify interventions to maximise cessation success in the event of a menthol ban. TRIAL REGISTRATION NUMBER NCT02342327.",2020,Post hoc analyses suggest that observed differences were largely due to a smaller proportion of participants in the non-menthol group relapsing within the first day of quitting (21% vs 40%; p=0.05).,"['Menthol smokers (particularly African-Americans', 'African-American smokers', 'African-American menthol cigarette smokers interested in quitting smoking either continued smoking menthol cigarettes (n=60) or']",['switched to non-menthol cigarettes'],"['time to relapse', 'time to smoking relapse (ie, number of days from quitting until the first of seven consecutive smoking days) and difference between groups in subjective measures', 'indications of delayed time to lapse', 'time to smoking lapse (ie, time from quitting until any smoking']","[{'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0522486', 'cui_str': 'Delay time'}]",,0.0205715,Post hoc analyses suggest that observed differences were largely due to a smaller proportion of participants in the non-menthol group relapsing within the first day of quitting (21% vs 40%; p=0.05).,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kotlyar', 'Affiliation': 'Department of Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, Minneapolis, Minnesota, USA kotly001@umn.edu.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Shanley', 'Affiliation': 'Biostatistics Core, Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Sheena R', 'Initials': 'SR', 'LastName': 'Dufresne', 'Affiliation': 'Department of Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Gretchen A', 'Initials': 'GA', 'LastName': 'Corcoran', 'Affiliation': 'Department of Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Kolawole S', 'Initials': 'KS', 'LastName': 'Okuyemi', 'Affiliation': 'Department of Family and Preventive Medicine, University of Utah Health, Salt Lake City, Utah, USA.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Mills', 'Affiliation': 'Department of Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Dorothy K', 'Initials': 'DK', 'LastName': 'Hatsukami', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, USA.'}]",Tobacco control,['10.1136/tobaccocontrol-2020-055689'] 1103,32720198,Comparing the effect of sitagliptin and metformin on the oocyte and embryo quality in classic PCOS patients undergoing ICSI.,"BACKGROUND Insulin resistance plays a major role in the pathogenesis of polycystic ovary syndrome (PCOS). Therefore, there is a growing interest in the use of insulin sensitizer drugs in the treatment of PCOS. Research in recent years has shown that sitagliptin has been reported to improve ovarian cycles and ovulation in PCOS patients. AIMS We aimed to compare the effects of metformin and sitagliptin on PCOS individuals undergoing ICSI. METHODS Sixty PCOS patients were divided into 3 groups: metformin, sitagliptin, and placebo group. Treatment was carried out 2 months before the start of the ovulation cycle and continued until the day of oocyte aspiration. The serum levels of total testosterone, estradiol, and fasting insulin along with the total number of retrieved, normal and abnormal MII, and fertilized oocytes, the number of transferred embryos (grades I, II and III), and biochemical and clinical pregnancy rates as well as the ovarian hyperstimulation syndrome (OHSS) were evaluated. RESULTS There was a significant reduction in the serum levels of Insulin and total testosterone in the treated groups compared with the placebo. The number of mature and normal MII oocytes increased significantly in the treated groups compared with the placebo. Moreover, the number of immature oocytes decreased significantly and the number of grade I embryos increases significantly in the sitagliptin group compared with the placebo group. CONCLUSION We conclude that sitagliptin can improve the maturation of oocytes and embryos' quality more effectively than metformin, in PCOS patients undergoing ICSI. TRIAL REGISTRATION Trial registration is NCT04268563 ( https://clinicaltrials.gov ).",2021,There was a significant reduction in the serum levels of Insulin and total testosterone in the treated groups compared with the placebo.,"['Sixty PCOS patients', 'PCOS patients undergoing ICSI', 'classic PCOS patients undergoing ICSI', 'PCOS patients', 'PCOS individuals undergoing ICSI']","['metformin and sitagliptin', 'metformin', 'sitagliptin', 'sitagliptin and metformin', 'metformin, sitagliptin, and placebo', 'placebo']","['number of immature oocytes', ""maturation of oocytes and embryos' quality"", 'number of mature and normal MII oocytes', 'number of grade I embryos', 'serum levels of Insulin and total testosterone', 'oocyte and embryo quality', 'serum levels of total testosterone, estradiol, and fasting insulin along with the total number of retrieved, normal and abnormal MII, and fertilized oocytes, the number of transferred embryos (grades I, II and III), and biochemical and clinical pregnancy rates as well as the ovarian hyperstimulation syndrome (OHSS']","[{'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1952576', 'cui_str': 'metformin and sitagliptin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205252', 'cui_str': 'Immature'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0202227', 'cui_str': 'Testosterone measurement, total'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0029974', 'cui_str': 'Ovum'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0085083', 'cui_str': 'Ovarian hyperstimulation syndrome'}]",60.0,0.172264,There was a significant reduction in the serum levels of Insulin and total testosterone in the treated groups compared with the placebo.,"[{'ForeName': 'Delbar', 'Initials': 'D', 'LastName': 'Daneshjou', 'Affiliation': 'Department of Biologyt, Faculty of Science, Arak University, Arak, Iran.'}, {'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Zadeh Modarres', 'Affiliation': ""Men's Health and Reproductive Health Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Malek', 'Initials': 'M', 'LastName': 'Soleimani Mehranjani', 'Affiliation': 'Department of Biologyt, Faculty of Science, Arak University, Arak, Iran. M-Soleimani@araku.ac.ir.'}, {'ForeName': 'Seyed Mohammad Ali', 'Initials': 'SMA', 'LastName': 'Shariat Zadeh', 'Affiliation': 'Department of Biologyt, Faculty of Science, Arak University, Arak, Iran.'}]",Irish journal of medical science,['10.1007/s11845-020-02320-5'] 1104,32720906,"Maternal Parenting Electronic Diary in the Context of a Home Visit Intervention for Adolescent Mothers in an Urban Deprived Area of São Paulo, Brazil: Randomized Controlled Trial.","BACKGROUND Pregnancy during adolescence is prevalent in low- and middle-income countries (LMICs), which is associated with various adverse outcomes that can be prevented with home visiting programs. However, testing these interventions in LMICs can be challenging due to limited resources. The use of electronic data collection via smartphones can be an alternative and ideal low-cost method to measure outcomes in an environment with adverse conditions. OBJECTIVE Our study had two objectives: to test the efficacy of a nurse home visiting intervention on maternal parenting and well-being measured by an electronic daily diary (eDiary), and to investigate the compliance rate of the eDiary measurement method. METHODS We conducted a randomized controlled trial to test the efficacy of Primeiros Laços, a nurse home visiting program, for adolescent mothers living in an urban deprived area of São Paulo, Brazil. A total of 169 pregnant adolescents were assessed for eligibility criteria, 80 of whom were included and randomized to the intervention (n=40) and control group (care as usual, n=40). Primeiros Laços is a home visiting intervention delivered by trained nurses tailored to first-time pregnant adolescents and their children, starting during the first 16 weeks of pregnancy until the child reaches 24 months of age. Participants were assessed by blind interviewers at 8-16 weeks of pregnancy (baseline), 30 weeks of pregnancy, and when the child was 3, 6, and 12 months of age. At 18 months, participants were assessed regarding maternal parenting and parental well-being using a 7-consecutive-day eDiary. The smartphone app was programmed to notify participants every day at 9:00 PM over a period of seven days. RESULTS We were able to contact 57/80 (71%) participants (29 from the intervention group and 28 from the control group) when the child was 18 months of age. Forty-eight of the 57 participants (84%) completed at least one day of the eDiary protocol. The daily compliance rate ranged from 49% to 70%. Our analyses showed a significant effect of the intervention on parental well-being (B=0.32, 95% CI [0.06, 0.58], P=.02) and the maternal parenting behavior of the mother telling a story or singing to the child (odds ratio=2.33, 95% CI [1.20, 4.50], P=.01).Our analyses showed a significant effect of the intervention on parental well-being (B=0.32, P=.02) and the maternal parenting behavior of the mother telling a story or singing to the child (odds ratio=2.33, P=.01). CONCLUSIONS The Primeiros Laços intervention improved maternal parenting and parental well-being, demonstrating its promise for low-income adolescent mothers. The compliance rate of the eDiary assessment showed that it was generally accepted by adolescent mothers with limited resources. Future studies can implement ambulatory assessment in LMICs via smartphones to measure mother and child behaviors. TRIAL REGISTRATION ClinicalTrials.gov NCT02807818; https://clinicaltrials.gov/ct2/show/NCT02807818.",2020,"Our analyses showed a significant effect of the intervention on parental well-being (B=0.32, 95% CI [0.06, 0.58], P=.02) and the maternal parenting behavior of the mother telling a story or singing to the child (odds ratio=2.33, 95% CI [1.20, 4.50], P=.01).Our analyses showed a significant effect of the intervention on parental well-being (B=0.32, P=.02) and the maternal parenting behavior of the mother telling a story or singing to the child (odds","['adolescent mothers living in an urban deprived area of São Paulo, Brazil', '169 pregnant adolescents were assessed for eligibility criteria, 80 of whom were included and randomized to the intervention (n=40) and control group (care as usual, n=40', 'Forty-eight of the 57 participants (84%) completed at least one day of the eDiary protocol', 'adolescent mothers with limited resources', 'Adolescent Mothers in an Urban Deprived Area of São Paulo, Brazil']","['Primeiros Laços, a nurse home visiting program', 'nurse home visiting intervention']","['compliance rate of the eDiary assessment', 'maternal parenting behavior of the mother telling a story or singing to the child (odds', 'maternal parenting behavior of the mother telling a story or singing to the child', 'Maternal Parenting Electronic Diary', 'maternal parenting and parental well-being', 'daily compliance rate']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",169.0,0.0833277,"Our analyses showed a significant effect of the intervention on parental well-being (B=0.32, 95% CI [0.06, 0.58], P=.02) and the maternal parenting behavior of the mother telling a story or singing to the child (odds ratio=2.33, 95% CI [1.20, 4.50], P=.01).Our analyses showed a significant effect of the intervention on parental well-being (B=0.32, P=.02) and the maternal parenting behavior of the mother telling a story or singing to the child (odds","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Fatori', 'Affiliation': 'Department of Psychiatry, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Argeu', 'Affiliation': 'Department of Psychiatry, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Brentani', 'Affiliation': 'Department of Psychiatry, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Chiesa', 'Affiliation': 'Collective Health Nursing Department, School of Nursing, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Lislaine', 'Initials': 'L', 'LastName': 'Fracolli', 'Affiliation': 'Collective Health Nursing Department, School of Nursing, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Matijasevich', 'Affiliation': 'Department of Preventive Medicine, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Euripedes C', 'Initials': 'EC', 'LastName': 'Miguel', 'Affiliation': 'Department of Psychiatry, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': 'Polanczyk', 'Affiliation': 'Department of Psychiatry, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}]",JMIR mHealth and uHealth,['10.2196/13686'] 1105,32725293,The influence of fish consumption on serum n-3 polyunsaturated fatty acid (PUFA) concentrations in women of childbearing age: a randomised controlled trial (the iFish Study).,"PURPOSE Long-chain polyunsaturated fatty acids (LCPUFA) can be synthesised endogenously from linoleic acid (LA) and α-linolenic acid (ALA) in a pathway involving the fatty acid desaturase (FADS) genes. Endogenous synthesis is inefficient; therefore, dietary intake of preformed LCPUFA from their richest source of fish is preferred. This study investigated the effect of fish consumption on PUFA concentrations in women of childbearing age while stratifying by FADS genotype. The influence of fish consumption on lipid profile, and markers of inflammation and oxidative stress was also examined. METHODS Healthy women (n = 49) provided a buccal swab which was analysed for FADS2 genotype (rs3834458; T/deletion). Participants were stratified according to genotype and randomised to an intervention group to receive either no fish (n = 18), 1 portion (n = 14) or 2 portions (n = 17) (140 g per portion) of fish per week for a period of 8 weeks. Serum PUFA was analysed at baseline and post-intervention. Lipid profile, and markers of inflammation and oxidative stress were also analysed. RESULTS Participants consuming 2 portions of fish per week had significantly higher concentrations of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and total n-3 PUFA, and a lower n-6:n-3 ratio compared to those in the no fish or 1 portion per week group (all p < 0.05). Fish consumption did not have a significant effect on biomarkers of oxidative stress, inflammation and lipid profile in the current study. CONCLUSION Consumption of 2 portions of fish per week has beneficial effects on biological n-3 PUFA concentrations in women of childbearing age; however, no effects on oxidative stress, inflammation or lipid profile were observed. This trial was registered at www.clinicaltrials.gov (NCT03765580), registered December 2018.",2021,"Fish consumption did not have a significant effect on biomarkers of oxidative stress, inflammation and lipid profile in the current study. ","['women of childbearing age while stratifying by FADS genotype', 'women of childbearing age', 'Healthy women (n\u2009=\u200949']","['chain polyunsaturated fatty acids (LCPUFA', 'fish consumption']","['serum n-3 polyunsaturated fatty acid (PUFA) concentrations', 'Lipid profile, and markers of inflammation and oxidative stress', 'PUFA concentrations', 'concentrations of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and total n-3 PUFA, and a lower n-6:n-3 ratio', 'biological n-3 PUFA concentrations', 'lipid profile, and markers of inflammation and oxidative stress', 'oxidative stress, inflammation or lipid profile', 'biomarkers of oxidative stress, inflammation and lipid profile', 'Serum PUFA']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0015680', 'cui_str': 'Fatty Acid Desaturating Enzymes'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}]","[{'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated fatty acid'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}]",,0.158035,"Fish consumption did not have a significant effect on biomarkers of oxidative stress, inflammation and lipid profile in the current study. ","[{'ForeName': 'Marie C', 'Initials': 'MC', 'LastName': 'Conway', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), School of Biomedical Sciences, Ulster University, Cromore Road, Coleraine, BT52 1SA, Northern Ireland, UK.'}, {'ForeName': 'Emeir M', 'Initials': 'EM', 'LastName': 'McSorley', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), School of Biomedical Sciences, Ulster University, Cromore Road, Coleraine, BT52 1SA, Northern Ireland, UK.'}, {'ForeName': 'Maria S', 'Initials': 'MS', 'LastName': 'Mulhern', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), School of Biomedical Sciences, Ulster University, Cromore Road, Coleraine, BT52 1SA, Northern Ireland, UK.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Spence', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), School of Biomedical Sciences, Ulster University, Cromore Road, Coleraine, BT52 1SA, Northern Ireland, UK.'}, {'ForeName': 'Edwin van', 'Initials': 'EV', 'LastName': 'Wijngaarden', 'Affiliation': 'School of Medicine and Dentistry, University of Rochester, Rochester, USA.'}, {'ForeName': 'Gene E', 'Initials': 'GE', 'LastName': 'Watson', 'Affiliation': 'School of Medicine and Dentistry, University of Rochester, Rochester, USA.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Wahlberg', 'Affiliation': 'The Laboratory of Medicine, Division of Occupational and Environmental Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pineda', 'Affiliation': 'The Laboratory of Medicine, Division of Occupational and Environmental Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Broberg', 'Affiliation': 'The Laboratory of Medicine, Division of Occupational and Environmental Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'Barry W', 'Initials': 'BW', 'LastName': 'Hyland', 'Affiliation': 'Mass Spectrometry Centre, Biomedical Sciences Research Institute (BMSRI), Ulster University, Coleraine, Northern Ireland, UK.'}, {'ForeName': 'Diego F', 'Initials': 'DF', 'LastName': 'Cobice', 'Affiliation': 'Mass Spectrometry Centre, Biomedical Sciences Research Institute (BMSRI), Ulster University, Coleraine, Northern Ireland, UK.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Strain', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), School of Biomedical Sciences, Ulster University, Cromore Road, Coleraine, BT52 1SA, Northern Ireland, UK.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Yeates', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), School of Biomedical Sciences, Ulster University, Cromore Road, Coleraine, BT52 1SA, Northern Ireland, UK. a.yeates@ulster.ac.uk.'}]",European journal of nutrition,['10.1007/s00394-020-02326-w'] 1106,33212067,"Immunogenicity and safety of simplified vaccination schedules for the CYD-TDV dengue vaccine in healthy individuals aged 9-50 years (CYD65): a randomised, controlled, phase 2, non-inferiority study.","BACKGROUND Three doses of the licensed tetravalent dengue vaccine CYD-TDV (Dengvaxia, Sanofi Pasteur, Lyon France) are immunogenic and effective against symptomatic dengue in individuals aged 9 years and older who are dengue seropositive. Previous trials have provided some evidence that antibody responses elicited after just one dose or two doses of CYD-TDV might be similar to those elicited after three doses. We compared antibody responses following one-dose, two-dose, and three-dose vaccination regimens in individuals who were dengue seropositive at baseline up to 1 year after the last injection. METHODS In this randomised, controlled, phase 2, non-inferiority study (CYD65), healthy individuals aged 9-50 years were recruited from the community in three sites in Colombia and three sites in the Philippines. Participants were randomly assigned (1:1:1), using a permuted block method with stratification by site and age group, to receive, at 6-month intervals (on day 0, month 6, and month 12), three doses of CYD-TDV (three-dose group), one dose of placebo (on day 0) and two doses of CYD-TDV (at months 6 and 12; two-dose group), or two doses of placebo (on day 0 and month 6) and one dose of CYD-TDV (at month 12; one-dose group). Each dose of CYD-TDV was 0·5 mL, administered subcutaneously into the deltoid of the upper arm. Participants, study staff, investigators, and the funder were masked to group assignment. The co-primary endpoints were geometric mean titres (GMTs) of neutralising antibodies against each dengue virus serotype at 28 days and 1 year after the last vaccine injection. After a protocol amendment during the conduct of the study, the original co-primary objectives of non-inferiority of the one-dose and two-dose groups to the three-dose group were altered to include non-inferiority of the two-dose group to the three-dose group only, to be assessed in individuals who were dengue seropositive at baseline. Non-inferiority was shown if the lower limit of the 95% CI for the ratio of GMTs (GMR) at 28 days and 1 year between groups was more than 0·5 for each serotype. The analysis of the coprimary objectives was done in the per-protocol analysis dataset, which included all participants who had been vaccinated, had no protocol deviations, and had a valid serology test result for at least one dengue serotype at 28 days after the third injection. Safety was assessed throughout in all participants who received at least one injection of study drug, regardless of serostatus. This trial is registered with ClinicalTrials.gov, NCT02628444, and is closed to accrual. FINDINGS Between May 2, 2016, and Sept 16, 2016, we recruited and enrolled 1050 individuals, of whom 1048 received at least one injection and 993 had at least one blood sample taken (full-analysis dataset; 333 in three-dose group, 328 in two-dose group, and 332 in one-dose group). 860 (86·6%) of 993 participants in the full-analysis dataset were dengue seropositive at baseline. Non-inferiority (two dose vs three dose) was shown for each serotype at both 28 days and 1 year among dengue-seropositive participants (number of participants assessed: 272 [two-dose group], 265 [three-dose group] at 28 days; and 190 [two-dose group], 185 [three-dose group] at 1 year). At 28 days after the last injection, neutralising antibody GMTs were 899 (95% CI 752-1075) in the two-dose group versus 822 (700-964) in the three dose group against dengue serotype 1 (GMR 1·09 [95% CI 0·86-1·39]); 869 (754-1002) versus 875 (770-995) against serotype 2 (GMR 0·99 [0·82-1·20]); 599 (524-685) versus 610 (535-694) against serotype 3 (GMR 0·98 [0·82-1·18]); and 510 (453-575) versus 531 (470-601) against serotype 4 (GMR 0·96 [0·81-1·14]). At year 1, GMTs had decreased but remained above baseline for all serotypes: 504 (95% CI 403-630) in the two-dose group versus 490 (398-604) in the three-dose group against serotype 1 (GMR 1·03 [0·76-1·40]); 737 (611-888) versus 821 (704-957) against serotype 2 (GMR 0·90 [0·71-1·14]); 437 (368-519) versus 477 (405-561) against serotype 3 (GMR 0·92 [0·72-1·16]); and 238 (205-277) versus 270 (235-310) against serotype 4 (GMR 0·88 [0·72-1·09]). Reactogenicity profiles were similar across treatment groups. Most unsolicited adverse events after any injection were non-serious and systemic in nature. During the study, 60 serious adverse events were reported in 58 participants (14 in three-dose group, 26 in two-dose group, 18 in one-dose group), mostly infection and infestations or injury, poisoning, and procedural complications. No serious adverse events of special interest or admissions to hospital for dengue occurred. Two deaths occurred, unrelated to study treatment. INTERPRETATION A two-dose CYD-TDV regimen might be an alternative to the licensed three-dose regimen in individuals who are dengue seropositive at baseline and aged 9 years and older. Vaccination with a reduced number of doses could lead to improved vaccine compliance and coverage, especially in low-resource settings. FUNDING Sanofi Pasteur.",2021,Non-inferiority (two dose vs three dose) was shown for each serotype at both 28 days and 1 year among dengue-seropositive participants (number of participants assessed:,"['Between May 2, 2016, and Sept 16, 2016, we recruited and enrolled 1050 individuals, of whom 1048 received at least one injection and 993 had at least one blood sample taken (full-analysis dataset; 333 in three-dose group, 328 in two-dose group, and 332 in one-dose group', 'healthy individuals aged 9-50 years were recruited from the community in three sites in Colombia and three sites in the Philippines', 'individuals who are dengue seropositive at baseline and aged 9 years and older', 'participants who had been vaccinated, had no protocol deviations, and had a valid serology test result for at least one dengue serotype at 28 days after the third injection', 'individuals aged 9 years and older who are dengue seropositive', 'healthy individuals aged 9-50 years (CYD65', '860 (86·6%) of 993 participants in the full-analysis dataset were dengue seropositive at baseline']","['CYD-TDV', 'placebo']","['Immunogenicity and safety', 'geometric mean titres (GMTs) of neutralising antibodies against each dengue virus serotype', 'Safety', 'neutralising antibody GMTs', 'mostly infection and infestations or injury, poisoning, and procedural complications', 'Reactogenicity profiles']","[{'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4517528', 'cui_str': '1050'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0190979', 'cui_str': 'Phlebotomy'}, {'cui': 'C0443225', 'cui_str': 'Full'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C4517724', 'cui_str': '333'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C3245499', 'cui_str': 'Colombia'}, {'cui': 'C0011311', 'cui_str': 'Dengue'}, {'cui': 'C0521143', 'cui_str': 'Seropositive'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0036743', 'cui_str': 'Serologic test'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0011315', 'cui_str': 'Dengue virus'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0032343', 'cui_str': 'Poisoning'}, {'cui': 'C1141861', 'cui_str': 'Procedural complication'}]",,0.361198,Non-inferiority (two dose vs three dose) was shown for each serotype at both 28 days and 1 year among dengue-seropositive participants (number of participants assessed:,"[{'ForeName': 'Diana Leticia', 'Initials': 'DL', 'LastName': 'Coronel-MartÍnez', 'Affiliation': 'Sanofi Pasteur, Santa Catarina, Coyoacán, Mexico City, Mexico. Electronic address: dianaLeticia.coronel@sanofi.com.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Sanofi Pasteur, Singapore.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'López-Medina', 'Affiliation': 'Centro de Estudios en Infectología Pediátrica, Universidad del Valle and Centro Médico Imbanaco, Cali, Valle del Cauca, Colombia.'}, {'ForeName': 'María Rosario', 'Initials': 'MR', 'LastName': 'Capeding', 'Affiliation': 'Research Institute for Tropical Medicine, Filinvest Corporate City, Alabang, Muntinlupa, Metro Manila, Philippines.'}, {'ForeName': 'Andrés Angelo', 'Initials': 'AA', 'LastName': 'Cadena Bonfanti', 'Affiliation': 'Clinica de la Costa, Barranquilla, Atlántico, Colombia.'}, {'ForeName': 'María Cecilia', 'Initials': 'MC', 'LastName': 'Montalbán', 'Affiliation': 'Manila Doctors Hospital, Ermita, Metro Manila, Philippines.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Ramírez', 'Affiliation': 'Infectious Diseases, Internal Medicine, Hospital Pablo Tobón Uribe, Universidad de Antioquia, Medellín, Antioquia, Colombia.'}, {'ForeName': 'María Liza Antoinette', 'Initials': 'MLA', 'LastName': 'Gonzales', 'Affiliation': 'University of the Philippines Manila-Philippine General Hospital, Ermita, Metro Manila, Philippines.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'DiazGranados', 'Affiliation': ""Sanofi Pasteur, Swiftwater, PA, USA; Sanofi Pasteur, Marcy L'Etoile, France.""}, {'ForeName': 'Betzana', 'Initials': 'B', 'LastName': 'Zambrano', 'Affiliation': 'Sanofi Pasteur, Montevideo, Uruguay.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Dayan', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Savarino', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Zhenghong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Sanofi Pasteur, Chaoyang, Beijing, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Sanofi Pasteur, Chaoyang, Beijing, China.'}, {'ForeName': 'Sunny', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'Sanofi Pasteur, Chaoyang, Beijing, China.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Bonaparte', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Rojas', 'Affiliation': 'Sanofi Pasteur, Bogotá, Colombia.'}, {'ForeName': 'Jenny Carolina', 'Initials': 'JC', 'LastName': 'Ramírez', 'Affiliation': 'Sanofi Pasteur, Bogotá, Colombia.'}, {'ForeName': 'Mae Ann', 'Initials': 'MA', 'LastName': 'Verdan', 'Affiliation': 'Sanofi Pasteur, Taguig, Metro Manila, Philippines.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Noriega', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30767-2'] 1107,33216421,"Effects of quercetin supplementation on inflammatory factors and quality of life in post-myocardial infarction patients: A double blind, placebo-controlled, randomized clinical trial.","Myocardial infarction (MI) is one of the leading causes of death in the world. Epidemiological studies have shown that dietary flavonoids are inversely related to cardiovascular morbidity and mortality. The study aimed to determine whether quercetin supplementation can improve inflammatory factors, total antioxidant capacity (TAC) and quality of life (QOL) in patients following MI. This randomized double-blind, placebo-controlled trial was conducted on 88 post-MI patients. Participants were randomly assigned into quercetin (n = 44) and placebo groups (n = 44) receiving 500 mg/day quercetin or placebo tablets for 8 weeks. Quercetin supplementation significantly increased serum TAC compared to placebo (Difference: 0.24 (0.01) mmol/L and 0.00 (0.00) mmol/L respectively; p < .001). TNF-α levels significantly decreased in the quercetin group (p = .009); this was not, however, significant compared to the placebo group. As for QOL dimensions, quercetin significantly lowered the scores of insecurity (Difference: -0.66 (12.5) and 0.00 (5.55) respectively; p < .001). No significant changes in IL-6, hs-CRP, blood pressure and other QOL dimensions were observed between the two groups. Quercetin supplementation (500 mg/day) in post-MI patients for 8 weeks significantly elevated TAC and improved the insecurity dimension of QOL, but failed to show any significant effect on inflammatory factors, blood pressure and other QOL dimensions.",2021,"No significant changes in IL-6, hs-CRP, blood pressure and other QOL dimensions were observed between the two groups.","['post-myocardial infarction patients', 'patients following MI', '88 post-MI patients']","['placebo', 'quercetin', 'Quercetin supplementation', 'placebo groups (n =\u200944) receiving 500\u2009mg/day quercetin or placebo tablets', 'quercetin supplementation']","['IL-6, hs-CRP, blood pressure and other QOL dimensions', 'inflammatory factors, total antioxidant capacity (TAC) and quality of life (QOL', 'inflammatory factors and quality of life', 'serum TAC', 'insecurity dimension of QOL', 'inflammatory factors, blood pressure and other QOL dimensions', 'Myocardial infarction (MI', 'cardiovascular morbidity and mortality', 'TNF-α levels']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034392', 'cui_str': 'Quercetin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0233497', 'cui_str': 'Insecurity'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.529179,"No significant changes in IL-6, hs-CRP, blood pressure and other QOL dimensions were observed between the two groups.","[{'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Dehghani', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Hashem', 'Initials': 'SH', 'LastName': 'Sezavar Seyedi Jandaghi', 'Affiliation': 'Rasool Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Janani', 'Affiliation': 'Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammadtaghi', 'Initials': 'M', 'LastName': 'Sarebanhassanabadi', 'Affiliation': 'Yazd Cardiovascular Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Emamat', 'Affiliation': 'Student Research Committee, Department of Clinical Nutrition and Dietetics, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Vafa', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6955'] 1108,33152158,Robot-assisted fluoroscopy-guided renal puncture for endoscopic combined intrarenal surgery: a pilot single-centre clinical trial.,,2021,,[],"['Robot-assisted fluoroscopy-guided renal puncture', 'endoscopic combined intrarenal surgery']",[],[],"[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",[],,0.107592,,"[{'ForeName': 'Kazumi', 'Initials': 'K', 'LastName': 'Taguchi', 'Affiliation': 'Department of Nephro-urology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Shuzo', 'Initials': 'S', 'LastName': 'Hamamoto', 'Affiliation': 'Department of Nephro-urology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Taiki', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Nephro-urology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Shoichiro', 'Initials': 'S', 'LastName': 'Iwatsuki', 'Affiliation': 'Department of Nephro-urology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Etani', 'Affiliation': 'Department of Nephro-urology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Okada', 'Affiliation': 'Department of Nephro-urology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Yasui', 'Affiliation': 'Department of Nephro-urology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}]",BJU international,['10.1111/bju.15291'] 1109,33227157,Mindfulness in Motion and Dietary Approaches to Stop Hypertension (DASH) in Hypertensive African Americans.,"OBJECTIVES Hypertension increases the risk of developing Alzheimer's disease or related dementias. This pilot study's purpose was to examine the feasibility and acceptability of a novel intervention, Mindfulness in Motion (MIM) and Dietary Approaches to Stop Hypertension DASH (MIM DASH), to improve diet, mindfulness, stress, and systolic blood pressure (BP) in older African Americans with mild cognitive impairment (MCI) and hypertension. DESIGN Cluster randomized controlled trial. SETTING Intergenerational community center in a large metropolitan area. PARTICIPANTS African Americans with MCI and hypertension. Participants were divided into six groups randomized 1:1:1 to the MIM DASH group, attention only (non-hypertensive education) group, or true control group. The MIM DASH and attention only interventions were delivered in 8-weekly 2 hour group sessions. MIM included mindful movements from chair/standing, breathing exercises, and guided meditation. The DASH component used a critical thinking approach of problem solving, goal setting, reflection, and self-efficacy. The true control group received a DASH pamphlet at the end. MEASUREMENTS Feasibility was tracked through enrollment and attendance records; acceptability was assessed through interviews. Blood pressure was measured using the Omron HEM-907XL Monitor. Dietary intake was measured by DASH-Q. Mindfulness was measured by the Cognitive and Affective Mindfulness Scale. Stress was measured by the Perceived Stress Scale. MCI was determined using the Self-Administered Gerocognitive Examination. Data were collected at baseline and 3-months. RESULTS Median session attendance was six for the MIM DASH group and six for the attention only group. There were no changes in diet, mindfulness, or stress. There was a clinically significant reduction in systolic BP in the MIM DASH group (-7.2 mmHg) relative to the attention only group (-.7), and no change between the MIM DASH and true control groups. CONCLUSION Results indicate that the MIM DASH intervention was feasible and culturally acceptable in African Americans with hypertension and MCI.",2021,"There was a clinically significant reduction in systolic BP in the MIM DASH group (-7.2 mmHg) relative to the attention only group (-.7), and no change between the MIM DASH and true control groups. ","['older African Americans with mild cognitive impairment (MCI) and hypertension', 'Hypertensive African Americans', 'African Americans with hypertension and MCI', 'African Americans with MCI and hypertension', 'Intergenerational community center in a large metropolitan area']","['DASH pamphlet', 'MIM DASH intervention', 'MIM DASH group, attention only (non-hypertensive education) group, or true control group', 'MIM DASH', 'Mindfulness in Motion and Dietary Approaches to Stop Hypertension (DASH', 'novel intervention, Mindfulness in Motion (MIM) and Dietary Approaches to Stop Hypertension DASH (MIM DASH']","['feasibility and acceptability', 'Perceived Stress Scale', 'MIM included mindful movements from chair/standing, breathing exercises, and guided meditation', 'DASH-Q. Mindfulness', 'Cognitive and Affective Mindfulness Scale', 'Dietary intake', 'Blood pressure', 'systolic BP', 'diet, mindfulness, or stress', 'diet, mindfulness, stress, and systolic blood pressure (BP']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205238', 'cui_str': 'True'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",,0.0147637,"There was a clinically significant reduction in systolic BP in the MIM DASH group (-7.2 mmHg) relative to the attention only group (-.7), and no change between the MIM DASH and true control groups. ","[{'ForeName': 'Kathy D', 'Initials': 'KD', 'LastName': 'Wright', 'Affiliation': 'College of Nursing, Center of Excellence in Critical and Complex Care, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Maryanna D', 'Initials': 'MD', 'LastName': 'Klatt', 'Affiliation': 'Department of Family and Community Medicine, The Ohio State University College of Medicine, Columbus, Ohio, USA.'}, {'ForeName': 'Ingrid Richards', 'Initials': 'IR', 'LastName': 'Adams', 'Affiliation': 'The Ohio State University College of Medicine, Columbus, Ohio, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Nguyen', 'Affiliation': 'The Ohio State University College of Medicine, Columbus, Ohio, USA.'}, {'ForeName': 'Lorraine C', 'Initials': 'LC', 'LastName': 'Mion', 'Affiliation': 'College of Nursing, Center of Excellence in Critical and Complex Care, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Alai', 'Initials': 'A', 'LastName': 'Tan', 'Affiliation': 'College of Nursing, Center of Excellence in Critical and Complex Care, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Todd B', 'Initials': 'TB', 'LastName': 'Monroe', 'Affiliation': 'College of Nursing, Center of Excellence in Critical and Complex Care, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Rose', 'Affiliation': 'College of Nursing, Center of Excellence in Critical and Complex Care, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Douglas W', 'Initials': 'DW', 'LastName': 'Scharre', 'Affiliation': 'The Ohio State University College of Medicine, Columbus, Ohio, USA.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16947'] 1110,32690725,"Correction: Effects of programmed intermittent thoracic paravertebral bolus of levobupivacaine on the spread of sensory block: a randomized, controlled, double-blind study .",,2020,,[],['levobupivacaine'],['spread of sensory block'],[],"[{'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}]","[{'cui': 'C0332261', 'cui_str': 'Spreading'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]",,0.431649,,[],Regional anesthesia and pain medicine,['10.1136/rapm-2018-100021corr1'] 1111,32695314,Effect of supraneural transforaminal epidural steroid injection combined with caudal epidural steroid injection with catheter in chronic radicular pain management: Double blinded randomized controlled trial.,"Background:  Epidural steroid injection (ESI) has been used in managing chronic radicular pain. Regarding various techniques of ESI, the synergistic effect of caudal ESI (CESI) on transforaminal ESI (TFESI) in chronic lumbosacral radicular pain in prospective randomized controlled trial has not been determined.  Methods :  A total of 54 eligible patients with lumbosacral radicular pain were randomly allocated to undergo TFESI plus CESI (TC group) or TFESI alone (T group).  The effective response to treatment was predefined by at least a 30% reduced verbal numerical rating scale (VNRS) from baseline between group comparison and the functional outcomes as measured by improved Oswestry Disability Index by least 15 points from baseline. All participants were evaluated using a single blinded outcome assessor before the  procedure and at 1, 3 and 6 months after the procedure. P <0.05 was considered as statistically significant.  Results :  Average VNRS reduced significantly from baseline after receiving procedure at 1, 3 and 6 months in both groups (P-value <0.05). The TC group exhibited more effective and showed significant pain relief compared with the T group at 3 months (P=0.01). However, no statistical difference was observed between sub group analysis in pain relief and insignificant difference between group comparisons of functional outcomes. Conclusions : A treatment combining TFESI and CESI showed significant pain relief over TFESI alone at 3 months. No effect was found concerning functional evaluation. Registration:  Thai Clinical Trials Registry ID TCTR20171101002 01/11/2017F.",2020,A treatment combining TFESI and CESI showed significant pain relief over TFESI alone in spondylolithesis and failed back surgery syndrome at 1 month.,"['chronic radicular pain management', 'chronic lumbosacral radicular pain', '54 eligible patients with lumbosacral radicular pain']","['Epidural steroid injection (ESI', 'TC', 'TFESI and CESI', 'caudal ESI (CESI', 'TFESI plus CESI (TC group) or TFESI alone (T group', 'supraneural transforaminal epidural steroid injection combined with caudal epidural steroid injection with catheter', 'transforaminal ESI (TFESI']","['Average VNRS', 'Oswestry Disability Index', 'pain relief', 'verbal numerical rating scale (VNRS']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0278147', 'cui_str': 'Radicular pain'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0450206', 'cui_str': 'Lumbosacral'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0196394', 'cui_str': 'Epidural steroid injection'}, {'cui': 'C0142580', 'cui_str': 'PI3 protein, human'}, {'cui': 'C0205097', 'cui_str': 'Caudal'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036669', 'cui_str': 'Group T'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0394837', 'cui_str': 'Local anesthetic sacral epidural block'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}]","[{'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",54.0,0.143353,A treatment combining TFESI and CESI showed significant pain relief over TFESI alone in spondylolithesis and failed back surgery syndrome at 1 month.,"[{'ForeName': 'Sithapan', 'Initials': 'S', 'LastName': 'Munjupong', 'Affiliation': 'Department of Anaesthesiology, Phramongkutklao Hospital and College of Medicine, Bangkok, Bangkok, 10400, Thailand.'}, {'ForeName': 'Wipoo', 'Initials': 'W', 'LastName': 'Kumnerddee', 'Affiliation': 'Department of Rehabilitation Medicine, Phramongkutklao Hospital and College of Medicine, Bangkok, Bangkok, 10400, Thailand.'}]",F1000Research,['10.12688/f1000research.23188.2'] 1112,32693615,A Prospective Randomized Trial of N-butyl-cyanoacrylate + Metacryloxysulfolane Adhesive versus Suture Alone for Grafting in Rhinoplasty: 9 year Follow-up.,"OBJECTIVE Use of cyanoacrylate glue in facial plastic surgery is still controversial due to the absence of long-term follow up showing the results. Aim of our study is comparing the long-term outcomes of N-butyl-cyanoacrylate + Metacryloxysulfolane versus traditional sutures in rhinoplasty. METHODS Prospective comparative study. One hundred forty-two patients affected by ptotic nasal tip were included and randomized in two groups. In group A, the surgeon fixed the graft by using the glue and suture and in group B by using the traditional suture only. The following data were collected and compared by statistical analysis: nasolabial angle before and after surgery, dimensions of the graft, duration time (in minutes) for graft application during the surgery, number of sutures applied to fix the graft, presence of post-surgery negative outcomes. RESULTS All patients statistically improved their nasolabial angle after surgery (ANOVA: P < .0001) without statistically significant differences between the two groups both at short and long follow-up (χ: P = 1 and P = .9 respectively). A statistically significant difference in graft fixation time ( P < .00001) and number of sutures (t: P < .00001) used was observed between the two groups. No statistically significant difference was observed in prevalence of infection after surgery. CONCLUSION N-butyl-cyanoacrylate + Metacryloxysulfolane could be a valid tool to reduce the necessary number of sutures and to reduce the time required for graft fixation graft fixation with consistent results in long-term follow-up.",2021,A statistically significant difference in graft fixation time ( P < .00001) and number of sutures (t: P < .00001) used was observed between the two groups.,"['One hundred forty-two patients affected by ptotic nasal tip', 'facial plastic surgery']","['N-butyl-cyanoacrylate + Metacryloxysulfolane', 'cyanoacrylate glue', 'N-butyl-cyanoacrylate + Metacryloxysulfolane Adhesive versus Suture Alone']","['nasolabial angle', 'number of sutures', 'prevalence of infection', 'time required for graft fixation graft fixation', 'graft fixation time']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0225409', 'cui_str': 'Structure of apex of nose'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0038911', 'cui_str': 'Plastic surgery - specialty'}]","[{'cui': 'C0014035', 'cui_str': 'Enbucrilate'}, {'cui': 'C0010507', 'cui_str': 'Cyanoacrylate'}, {'cui': 'C0017780', 'cui_str': 'Glue'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}]","[{'cui': 'C0429143', 'cui_str': 'Nasolabial angle'}, {'cui': 'C0457280', 'cui_str': 'Number of sutures'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]",142.0,0.0413664,A statistically significant difference in graft fixation time ( P < .00001) and number of sutures (t: P < .00001) used was observed between the two groups.,"[{'ForeName': 'Carmine', 'Initials': 'C', 'LastName': 'Martino', 'Affiliation': 'University Hospital of Salerno, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Salzano', 'Affiliation': 'University Hospital of Salerno, Italy.'}, {'ForeName': 'Diletta', 'Initials': 'D', 'LastName': 'Martino', 'Affiliation': 'The nose clinic, rhinosurgery unit c/o check-up day-surgery Salerno, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Ralli', 'Affiliation': 'Organ of Sense Department, La Sapienza University of Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'De Vincentiis', 'Affiliation': 'Organ of Sense Department, La Sapienza University of Rome, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Maranzano', 'Affiliation': 'Department of Oral Maxillo-Facial and Facial Plastic Surgery, University of Manchester, Manchester, UK.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Greco', 'Affiliation': 'Organ of Sense Department, La Sapienza University of Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Salzano', 'Affiliation': 'Head and Neck Department, Neurosciences, Reproductive and Odontostomatological Science, University Federico II, Naples, Italy.'}, {'ForeName': 'Arianna', 'Initials': 'A', 'LastName': 'Di Stadio', 'Affiliation': 'Otolaryngology Department, University of Perugia, Perugia, Italy.'}]","The Annals of otology, rhinology, and laryngology",['10.1177/0003489420943910'] 1113,32694619,Salvage autologous transplant and lenalidomide maintenance vs. lenalidomide/dexamethasone for relapsed multiple myeloma: the randomized GMMG phase III trial ReLApsE.,"The role of salvage high-dose chemotherapy and autologous stem cell transplantation (sHDCT/ASCT) for relapsed and/or refractory multiple myeloma (RRMM) in the era of continuous novel agent treatment has not been defined. This randomized, open-label, phase III, multicenter trial randomized patients with 1st-3rd relapse of multiple myeloma (MM) to a transplant arm (n = 139) consisting of 3 Rd (lenalidomide 25 mg, day 1-21; dexamethasone 40 mg, day 1, 8, 15, and 22; 4-week cycles) reinduction cycles, sHDCT (melphalan 200 mg/m 2 ), ASCT, and lenalidomide maintenance (10 mg/day) or to a control arm (n = 138) of continuous Rd. Median PFS was 20.7 months in the transplant and 18.8 months in the control arm (HR 0.87; 95% CI 0.65-1.16; p = 0.34). Median OS was not reached in the transplant and 62.7 months in the control arm (HR 0.81; 95% CI 0.52-1.28; p = 0.37). Forty-one patients (29%) did not receive the assigned sHDCT/ASCT mainly due to early disease progression, adverse events, and withdrawal of consent. Multivariate landmark analyses from the time of sHDCT showed superior PFS and OS (p = 0.0087/0.0057) in patients who received sHDCT/ASCT. Incorporation of sHDCT/ASCT into relapse treatment with Rd was feasible in 71% of patients and did not significantly prolong PFS and OS on ITT analysis while patients who received sHDCT/ASCT may have benefitted.",2021,Multivariate landmark analyses from the time of sHDCT showed superior PFS and OS (p = 0.0087/0.0057) in patients who received sHDCT/ASCT.,"['relapsed multiple myeloma', 'multicenter trial randomized patients with 1st-3rd relapse of multiple myeloma (MM) to a transplant arm (n\u2009=\u2009139) consisting of', 'relapsed and/or refractory multiple myeloma (RRMM']","['3 Rd (lenalidomide 25\u2009mg, day 1-21; dexamethasone', 'Salvage autologous transplant and lenalidomide maintenance vs. lenalidomide/dexamethasone', 'sHDCT/ASCT', 'sHDCT (melphalan 200\u2009mg/m 2 ), ASCT, and lenalidomide maintenance', 'salvage high-dose chemotherapy and autologous stem cell transplantation (sHDCT/ASCT']","['superior PFS and OS', 'Median PFS', 'Median OS', 'early disease progression, adverse events, and withdrawal of consent']","[{'cui': 'C2349261', 'cui_str': 'Relapse multiple myeloma'}, {'cui': 'C0206012', 'cui_str': 'Multicentre Trials'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}]","[{'cui': 'C1724165', 'cui_str': 'lenalidomide 25 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]",,0.0568923,Multivariate landmark analyses from the time of sHDCT showed superior PFS and OS (p = 0.0087/0.0057) in patients who received sHDCT/ASCT.,"[{'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Goldschmidt', 'Affiliation': 'Department of Hematology, Oncology and Rheumatology, University Hospital Heidelberg, Heidelberg, Germany. hartmut.goldschmidt@med.uni-heidelberg.de.'}, {'ForeName': 'Marc-Andrea', 'Initials': 'MA', 'LastName': 'Baertsch', 'Affiliation': 'Department of Hematology, Oncology and Rheumatology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Schlenzka', 'Affiliation': 'Department of Hematology, Oncology and Rheumatology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Becker', 'Affiliation': 'Division of Biostatistics, German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Habermehl', 'Affiliation': 'Division of Biostatistics, German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hielscher', 'Affiliation': 'Division of Biostatistics, German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Marc-Steffen', 'Initials': 'MS', 'LastName': 'Raab', 'Affiliation': 'Department of Hematology, Oncology and Rheumatology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Hillengass', 'Affiliation': 'Department of Hematology, Oncology and Rheumatology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Sauer', 'Affiliation': 'Department of Hematology, Oncology and Rheumatology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Müller-Tidow', 'Affiliation': 'Department of Hematology, Oncology and Rheumatology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Luntz', 'Affiliation': 'Coordination Centre for Clinical Trials (KKS), University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Jauch', 'Affiliation': 'Institute for Human Genetics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Hose', 'Affiliation': 'Department of Hematology, Oncology and Rheumatology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Seckinger', 'Affiliation': 'Department of Hematology, Oncology and Rheumatology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brossart', 'Affiliation': 'Department of Oncology, Hematology, Immuno-Oncology and Rheumatology, Med. Klinik und Poliklinik III, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Goerner', 'Affiliation': 'Department of Hematology, Oncology and Palliative Care, Community Hospital Bielefeld, Bielefeld, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Klein', 'Affiliation': 'Department of Hematology and Oncology, University Hospital Mannheim, Mannheim, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schmidt-Hieber', 'Affiliation': 'Clinic for Hematology and Stem Cell Transplantation, Helios-Hospital Berlin Buch, Berlin, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Reimer', 'Affiliation': 'Department of Hematology, Oncology and Stem Cell Transplantation, Evangelisches Krankenhaus Essen-Werden gGmbH, Essen, Germany.'}, {'ForeName': 'Ullrich', 'Initials': 'U', 'LastName': 'Graeven', 'Affiliation': 'Department of Hematology, Oncology and Gastroenterology, Kliniken Maria Hilf GmbH, Mönchengladbach, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Fenk', 'Affiliation': 'Department of Hematology, Oncology and Clinical Immunology, University of Duesseldorf, Duesseldorf, Germany.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Haenel', 'Affiliation': 'Department of Hematology, Oncology and Stem Cell Transplantation, Klinikum Chemnitz GmbH, Chemnitz, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Martin', 'Affiliation': 'Department of Hematology and Oncology, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Hans W', 'Initials': 'HW', 'LastName': 'Lindemann', 'Affiliation': 'Department of Hematology and Oncology, Kath. Krankenhaus Hagen gem. GmbH, Hagen, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Scheid', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Nogai', 'Affiliation': 'Internal Medicine III, Charité Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Salwender', 'Affiliation': 'Asklepios Tumorzentrum Hamburg, AK Altona and AK St. Georg, Hamburg, Germany.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Noppeney', 'Affiliation': 'Department of Hematology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Besemer', 'Affiliation': 'Department of Hematology, Oncology and Immunology, University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Weisel', 'Affiliation': 'Department of Oncology, Hematology and Bone Marrow Transplantation with Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Leukemia,['10.1038/s41375-020-0948-0'] 1114,32698860,Automated vs. conventional ventilation in the ICU: a randomized controlled crossover trial comparing blood oxygen saturation during daily nursing procedures (I-NURSING).,"BACKGROUND Hypoxia is common during daily nursing procedures (DNPs) routinely performed on mechanically ventilated patients. The impact of automated ventilation on the incidence and severity of blood oxygen desaturation during DNPs remains unknown. METHODS A prospective randomized controlled crossover trial was carried out in a French intensive care unit to compare blood oxygen pulse saturation (SpO 2 ) during DNPs performed on patients mechanically ventilated in automated and conventional ventilation modes (AV and CV, respectively). All patients with FiO 2  ≤ 60% and without prone positioning or neuromuscular blocking agents were included. Patients underwent two DNPs on the same day using AV (INTELLiVENT-ASV®) and CV (volume control, biphasic positive airway pressure, or pressure support ventilation) in a randomized order. The primary outcome was the percentage of time spent with SpO 2 in the acceptable range of 90-95% during the DNP. RESULTS Of the 265 included patients, 93% had been admitted for a medical pathology, the majority for acute respiratory failure (52%). There was no difference between the two periods in terms of DNP duration, sedation requirements, or ventilation parameters, but patients had more spontaneous breaths and lower peak airway pressures during the AV period (p <  0.001). The percentage of time spent with SpO 2 in the acceptable range during DNPs was longer in the AV period than in the CV period (48 ± 37 vs. 43 ± 37, percentage of DNP period; p = 0.03). After adjustment, AV was associated with a higher number of DNPs carried out with SpO 2 in the acceptable range (odds ratio, 1.82; 95% CI, 1.28 to 2.6; p = 0.001) and a lower incidence of blood oxygen desaturation ≤ 85% (adjusted odds ratio, 0.50; 95% CI, 0.30 to 0.85; p = 0.01). CONCLUSION AV appears to reduce the incidence and severity of blood oxygen desaturation during daily nursing procedures (DNPs) in comparison to CV. TRIAL REGISTRATION This study was registered in clinical-trial.gov ( NCT03176329 ) in June 2017.",2020,"There was no difference between the two periods in terms of DNP duration, sedation requirements, or ventilation parameters, but patients had more spontaneous breaths and lower peak airway pressures during the AV period (p <  0.001).","['All patients with FiO 2 \u2009≤\u200960% and without prone positioning or neuromuscular blocking agents were included', 'Of the 265 included patients', 'patients mechanically ventilated in automated and conventional ventilation modes (AV and CV, respectively', 'mechanically ventilated patients']","['conventional ventilation', 'CV (volume control, biphasic positive airway pressure, or pressure support ventilation', 'automated ventilation', 'blood oxygen saturation']","['DNP duration, sedation requirements, or ventilation parameters', 'acute respiratory failure', 'spontaneous breaths and lower peak airway pressures', 'percentage of time spent with SpO 2', 'percentage of time spent with SpO 2 in the acceptable range', 'blood oxygen desaturation', 'blood oxygen pulse saturation (SpO 2 ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0027866', 'cui_str': 'Neuromuscular blocking agent'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0449972', 'cui_str': 'Volume control'}, {'cui': 'C1611149', 'cui_str': 'Bilevel positive airway pressure'}, {'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen'}]","[{'cui': 'C0045511', 'cui_str': '2,4-dinitrophenol'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}]",,0.163451,"There was no difference between the two periods in terms of DNP duration, sedation requirements, or ventilation parameters, but patients had more spontaneous breaths and lower peak airway pressures during the AV period (p <  0.001).","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Chelly', 'Affiliation': 'Intensive Care Unit, Groupe Hospitalier Sud Ile de France, 270 avenue Marc Jacquet, 77000, Melun, France. jonathanchelly1@gmail.com.'}, {'ForeName': 'Sandie', 'Initials': 'S', 'LastName': 'Mazerand', 'Affiliation': 'Intensive Care Unit, Groupe Hospitalier Sud Ile de France, 270 avenue Marc Jacquet, 77000, Melun, France.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Jochmans', 'Affiliation': 'Intensive Care Unit, Groupe Hospitalier Sud Ile de France, 270 avenue Marc Jacquet, 77000, Melun, France.'}, {'ForeName': 'Claire-Marie', 'Initials': 'CM', 'LastName': 'Weyer', 'Affiliation': 'Intensive Care Unit, Groupe Hospitalier Sud Ile de France, 270 avenue Marc Jacquet, 77000, Melun, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Pourcine', 'Affiliation': 'Intensive Care Unit, Groupe Hospitalier Sud Ile de France, 270 avenue Marc Jacquet, 77000, Melun, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Ellrodt', 'Affiliation': 'Intensive Care Unit, Groupe Hospitalier Sud Ile de France, 270 avenue Marc Jacquet, 77000, Melun, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Thieulot-Rolin', 'Affiliation': 'Intensive Care Unit, Groupe Hospitalier Sud Ile de France, 270 avenue Marc Jacquet, 77000, Melun, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Serbource-Goguel', 'Affiliation': 'Intensive Care Unit, Groupe Hospitalier Sud Ile de France, 270 avenue Marc Jacquet, 77000, Melun, France.'}, {'ForeName': 'Oumar', 'Initials': 'O', 'LastName': 'Sy', 'Affiliation': 'Intensive Care Unit, Groupe Hospitalier Sud Ile de France, 270 avenue Marc Jacquet, 77000, Melun, France.'}, {'ForeName': 'Ly Van Phach', 'Initials': 'LVP', 'LastName': 'Vong', 'Affiliation': 'Intensive Care Unit, Groupe Hospitalier Sud Ile de France, 270 avenue Marc Jacquet, 77000, Melun, France.'}, {'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Monchi', 'Affiliation': 'Intensive Care Unit, Groupe Hospitalier Sud Ile de France, 270 avenue Marc Jacquet, 77000, Melun, France.'}]","Critical care (London, England)",['10.1186/s13054-020-03155-3'] 1115,32699911,The effect of a split portion of flaxseed on 24-h blood glucose response.,"PURPOSE Flaxseed can be effective at lowering and stabilising blood glucose responses. The aim of this study was to determine whether flaxseed could lower blood glucose response more effectively when consumed as a single portion of 30 g, or a split portion consumed three times per day (10 g flaxseed per portion). METHODS The study was a randomised, repeated measures, cross-over design. Fifteen healthy participants consumed either (1) three flaxseed muffins containing a total of 30 g of flaxseed once in the morning, (2) three flaxseed muffins consumed at three different timepoints across the day (10 g flaxseed per muffin) or (3) three control muffins consumed at three different timepoints across the day (0 g flaxseed). The 24-h blood glucose response was measured using a continuous glucose monitor. RESULTS The results of this study demonstrated that flaxseed muffins given three times a day were effective at lowering and maintaining blood glucose levels over 24 h, compared to the control muffins and that both flaxseed treatments resulting in a lower blood glucose iAUC during the night. CONCLUSION The results of this study indicated that adding flaxseed to a daily diet produced a lower glucose profile over 24 h in a free-living context compared to the control muffins.",2021,The results of this study indicated that adding flaxseed to a daily diet produced a lower glucose profile over 24 h in a free-living context compared to the control muffins.,['Fifteen healthy participants'],[],"['blood glucose iAUC', '24-h blood glucose response', 'blood glucose response', 'effective at lowering and maintaining blood glucose levels']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]",[],"[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}]",15.0,0.0400749,The results of this study indicated that adding flaxseed to a daily diet produced a lower glucose profile over 24 h in a free-living context compared to the control muffins.,"[{'ForeName': 'Awatif', 'Initials': 'A', 'LastName': 'Almehmadi', 'Affiliation': 'Department of Sport, Health Sciences and Social Work, Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, OX3 0BP, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Lightowler', 'Affiliation': 'Department of Sport, Health Sciences and Social Work, Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, OX3 0BP, UK.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Chohan', 'Affiliation': ""Department of Health and Exercise Science, Faculty of Sport, Health and Applied Science, St Mary's University, Twickenham, TW1 4SX, UK.""}, {'ForeName': 'Miriam E', 'Initials': 'ME', 'LastName': 'Clegg', 'Affiliation': 'Department of Food and Nutritional Sciences, School of Chemistry, Food and Pharmacy, University of Reading, Reading, RG6 6AP, UK. m.e.clegg@reading.ac.uk.'}]",European journal of nutrition,['10.1007/s00394-020-02333-x'] 1116,32700389,Do physician incentives increase patient medication adherence?,"OBJECTIVE To test the effectiveness of physician incentives for increasing patient medication adherence in three drug classes: diabetes medication, antihypertensives, and statins. DATA SOURCES Pharmacy and medical claims from a large Medicare Advantage Prescription Drug Plan from January 2011 to December 2012. STUDY DESIGN We conducted a randomized experiment (911 primary care practices and 8,935 nonadherent patients) to test the effect of paying physicians for increasing patient medication adherence in three drug classes: diabetes medication, antihypertensives, and statins. We measured patients' medication adherence for 18 (6) months before (after) the intervention. DATA COLLECTION/EXTRACTION METHODS We obtained data directly from the health insurer. PRINCIPAL FINDINGS We found no evidence that physician incentives increased adherence in any drug class. Our results rule out increases in the proportion of days covered by medication larger than 4.2 percentage points. CONCLUSIONS Physician incentives of $50 per patient per drug class are not effective for increasing patient medication adherence among the drug classes and primary care practices studied. Such incentives may be more likely to improve measures under physicians' direct control rather than those that predominantly reflect patient behaviors. Additional research is warranted to disentangle whether physician effort is not responsive to these types of incentives, or medication adherence is not responsive to physician effort. Our results suggest that significant changes in the incentive amount or program design may be necessary to produce responses from physicians or patients.",2020,"CONCLUSIONS Physician incentives of $50 per patient per drug class are not effective for increasing patient medication adherence among the drug classes and primary care practices studied.","['911 primary care practices and 8,935 nonadherent patients']","['paying physicians for increasing patient medication adherence in three drug classes: diabetes medication, antihypertensives, and statins']",['patient medication adherence'],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",,0.0217103,"CONCLUSIONS Physician incentives of $50 per patient per drug class are not effective for increasing patient medication adherence among the drug classes and primary care practices studied.","[{'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Kong', 'Affiliation': 'Harvard Medical School, Boston, MA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Beshears', 'Affiliation': 'Negotiation, Organizations & Markets Unit, Harvard Business School, Boston, MA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Laibson', 'Affiliation': 'Harvard Department of Economics, Cambridge, MA.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Madrian', 'Affiliation': 'National Bureau of Economic Research, Cambridge, MA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Volpp', 'Affiliation': 'Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Loewenstein', 'Affiliation': 'Department of Social and Decision Sciences, Carnegie Mellon University Dietrich College of Humanities and Social Sciences, Pittsburgh, PA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Kolstad', 'Affiliation': 'National Bureau of Economic Research, Cambridge, MA.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Choi', 'Affiliation': 'National Bureau of Economic Research, Cambridge, MA.'}]",Health services research,['10.1111/1475-6773.13322'] 1117,32702664,Effect of an Exergaming-Based Dance Training Paradigm on Autonomic Nervous System Modulation in Healthy Older Adults: A Randomized Controlled Trial.,"The purpose of this study was to determine if an exergaming-based dance training protocol can improve heart rate variability (HRV) in healthy older adults. A total of 20 healthy older adults (≥65 years old) were randomly assigned to two groups. The intervention group received an exergaming-based dance aerobic training for 6 weeks, while the control group received a 1-hr education on conventional physical exercises. Data obtained from HRV analysis pre- (Week 0) and postintervention (Week 7) consisted of high-frequency power, low- and high-frequency ratio, and root mean square of differences and percentage of adjacent RR intervals with a difference of duration greater than 50 ms values. HRV was assessed during rest and during a 6-min walk test. In addition, the YMCA submaximal cycle ergometer test was used to acquire estimated maximal O2 consumption pre- and postintervention. After the training, the intervention group showed significant improvement in HRV high-frequency power, root mean square of differences, and percentage of adjacent RR intervals with a difference of duration greater than 50 ms values in both rest and 6-min walk test conditions compared with the control group. Similarly, the intervention group showed higher maximal O2 consumption compared with the control group after the training. Our results support the effectiveness of an exergaming-based dance aerobic training on improving cardiac autonomic control in aging.",2020,"After the training, the intervention group showed significant improvement in HRV high-frequency power, root mean square of differences, and percentage of adjacent RR intervals with a difference of duration greater than 50 ms values in both rest and 6-min walk test conditions compared with the control group.","['20 healthy older adults (≥65 years old', 'healthy older adults', 'Healthy Older Adults']","['exergaming-based dance aerobic training', 'exergaming-based dance training protocol', 'exergaming-based dance aerobic training for 6 weeks, while the control group received a 1-hr education on conventional physical exercises', 'Exergaming-Based Dance Training Paradigm']","['HRV high-frequency power, root mean square of differences, and percentage of adjacent RR intervals', 'maximal O2 consumption', 'HRV', 'cardiac autonomic control', 'heart rate variability (HRV']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",20.0,0.0577257,"After the training, the intervention group showed significant improvement in HRV high-frequency power, root mean square of differences, and percentage of adjacent RR intervals with a difference of duration greater than 50 ms values in both rest and 6-min walk test conditions compared with the control group.","[{'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Varas-Diaz', 'Affiliation': ''}, {'ForeName': 'Savitha', 'Initials': 'S', 'LastName': 'Subramaniam', 'Affiliation': ''}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Delgado', 'Affiliation': ''}, {'ForeName': 'Shane A', 'Initials': 'SA', 'LastName': 'Phillips', 'Affiliation': ''}, {'ForeName': 'Tanvi', 'Initials': 'T', 'LastName': 'Bhatt', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2019-0452'] 1118,32702706,"Fitness, Strength and Body Composition during Weight Loss in Women with Clinically Severe Obesity: A Randomised Clinical Trial.","INTRODUCTION To determine whether combined exercise training with an energy-restricted diet leads to improved physical fitness and body composition when compared to energy restriction alone in free-living premenopausal women with clinically severe obesity. METHODS Sixty premenopausal women (BMI of 40.4 ± 6.7) were randomised to energy restriction only (ER) or to exercise plus energy restriction (EXER) for 12 months. Body composition and fitness were measured at baseline, 3, 6 and 12 months. RESULTS VO2 peak improved more for EXER compared to ER at 3 (mean difference ± SEM 2.5 ± 0.9 mL ∙ kg-1 ∙ min-1, p = 0.006) and 6 (3.1 ± 1.2 mL ∙ kg-1 ∙ min-1, p = 0.007) but not 12 months (2.3 ± 1.6 mL ∙ kg-1 ∙ min-1, p = 0.15). Muscle strength improved more for EXER compared to ER at all time points. No differences between groups for lean mass were observed at 12 months. CONCLUSION Combining exercise training with an energy-restricted diet did not lead to greater aerobic power, total body mass, fat mass or limit lean body mass loss at 12 months when compared to energy restriction alone for premenopausal women with clinically severe obesity in free-living situations. Future research should aim to determine an effective lifestyle approach which can be applied in the community setting for this high-risk group.",2020,"Combining exercise training with an energy-restricted diet did not lead to greater aerobic power, total body mass, fat mass or limit lean body mass loss at 12 months when compared to energy restriction alone for premenopausal women with clinically severe obesity in free-living situations.","['premenopausal women with clinically severe obesity in free-living situations', 'free-living premenopausal women with clinically severe obesity', 'Sixty premenopausal women (BMI of 40.4 ± 6.7', 'Women with Clinically Severe Obesity']","['EXER', 'energy restriction only (ER) or to exercise plus energy restriction (EXER', 'energy restriction alone', 'Combining exercise training with an energy-restricted diet', 'mL', 'combined exercise training']","['Fitness, Strength and Body Composition during Weight Loss', 'Muscle strength', 'lean mass', 'VO2 peak', 'aerobic power, total body mass, fat mass or limit lean body mass loss', 'physical fitness and body composition', 'Body composition and fitness']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0667627', 'cui_str': 'bis(kojato)oxovanadium(IV)'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}]",60.0,0.0944376,"Combining exercise training with an energy-restricted diet did not lead to greater aerobic power, total body mass, fat mass or limit lean body mass loss at 12 months when compared to energy restriction alone for premenopausal women with clinically severe obesity in free-living situations.","[{'ForeName': 'Clint T', 'Initials': 'CT', 'LastName': 'Miller', 'Affiliation': 'School of Exercise and Nutrition Sciences, Deakin University, Geelong, Victoria, Australia, c.miller@deakin.edu.au.'}, {'ForeName': 'Steve F', 'Initials': 'SF', 'LastName': 'Fraser', 'Affiliation': 'School of Exercise and Nutrition Sciences, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Steve E', 'Initials': 'SE', 'LastName': 'Selig', 'Affiliation': 'School of Exercise and Nutrition Sciences, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Rice', 'Affiliation': 'Clinical Obesity Research Laboratory, Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Mariee', 'Initials': 'M', 'LastName': 'Grima', 'Affiliation': 'Clinical Obesity Research Laboratory, Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'van den Hoek', 'Affiliation': 'Institute for Physical Activity and Nutrition, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Ika Sari', 'Affiliation': 'Human Neurotransmitters and Clinical Obesity Research Laboratory, Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Gavin W', 'Initials': 'GW', 'LastName': 'Lambert', 'Affiliation': 'Human Neurotransmitters and Clinical Obesity Research Laboratory, Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Dixon', 'Affiliation': 'Clinical Obesity Research Laboratory, Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}]",Obesity facts,['10.1159/000506643'] 1119,32705319,"Effects of morphine on peri-articular infiltration analgesia in total knee arthroplasty: a prospective, double-blind, randomized controlled trial.","PURPOSE Peri-articular infiltration analgesia (PIA) is a widely used method to control post-operative pain in total knee arthroplasty (TKA) patients. However, there are limited data that support the use of morphine in PIA. This study aims to evaluate the efficacy of peri-articular morphine infiltration for pain management in TKA patients. METHODS Based on a double-blind, randomized approach, patients were allocated to the morphine or control group. Patients in the morphine group received a peri-articular infiltration of an analgesic cocktail consisting of ropivacaine, epinephrine, and morphine. Morphine was omitted from the cocktail in the control group. Primary outcomes were post-operative consumption of morphine hydrochloride used for rescue analgesia and post-operative pain as assessed by visual analog scale (VAS) score. Secondary outcomes were functional recovery as assessed by a range of knee motion, quadriceps strength, and daily ambulation distance. The duration of hospital stay was also recorded. Tertiary outcomes included the occurrence of post-operative adverse effects and the consumption of antiemetics. RESULTS Patients in the morphine group had significantly lower post-operative morphine consumption in the first 24 h and total morphine consumption. There was no significant difference between the two groups in post-operative VAS pain scores at rest or during motion. There was no significant difference between the two groups in the post-operative knee range of motion, quadriceps strength, daily ambulation distance, or duration of post-operative hospital stay. The two groups were similar in the incidence of adverse effects and the consumption of antiemetics. CONCLUSION Adding morphine into the analgesic cocktail of PIA could reduce postoperative morphine consumption in TKA patients, but does not improve early pain relief or accelerate functional recovery or provide clinical benefits for TKA patients. In addition, the complications and safety of peri-articular morphine infiltration need to be further investigated in larger sample studies.",2020,"There was no significant difference between the two groups in the post-operative knee range of motion, quadriceps strength, daily ambulation distance, or duration of post-operative hospital stay.","['total knee arthroplasty', 'TKA patients', 'pain management in TKA patients', 'total knee arthroplasty (TKA) patients']","['ropivacaine, epinephrine, and morphine', 'morphine', 'peri-articular morphine infiltration', 'Morphine', 'Peri-articular infiltration analgesia (PIA']","['occurrence of post-operative adverse effects and the consumption of antiemetics', 'adverse effects and the consumption of antiemetics', 'post-operative morphine consumption', 'post-operative consumption of morphine hydrochloride used for rescue analgesia and post-operative pain as assessed by visual analog scale (VAS) score', 'functional recovery as assessed by a range of knee motion, quadriceps strength, and daily ambulation distance', 'post-operative knee range of motion, quadriceps strength, daily ambulation distance, or duration of post-operative hospital stay', 'post-operative VAS pain scores', 'duration of hospital stay']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0770901', 'cui_str': 'Morphine hydrochloride'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0576094', 'cui_str': 'Knee joint - range of movement'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}]",,0.223407,"There was no significant difference between the two groups in the post-operative knee range of motion, quadriceps strength, daily ambulation distance, or duration of post-operative hospital stay.","[{'ForeName': 'Qiuru', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopaedics Surgery, West China Hospital, Sichuan University, 37# Wainan Guoxue Road, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Jikui', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': ""State Key Laboratory of Oral Diseases, West China School Stomatology, Sichuan University, No. 14, Third Section South Renmin Road, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Yunlian', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': ""Department of General Surgery, Yongchuan Hospital of Traditional Chinese Medicine, 2# Yingbin Road, Yongchuan, Chongqing, 402160, People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': ""Department of Anesthesiology, West China Hospital, Sichuan University, 37# Wainan Guoxue Road, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': ""Department of Anesthesiology, West China Hospital, Sichuan University, 37# Wainan Guoxue Road, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Anesthesiology, West China Hospital, Sichuan University, 37# Wainan Guoxue Road, Chengdu, 610041, People's Republic of China. hxyangjing@qq.com.""}, {'ForeName': 'Pengde', 'Initials': 'P', 'LastName': 'Kang', 'Affiliation': ""Department of Orthopaedics Surgery, West China Hospital, Sichuan University, 37# Wainan Guoxue Road, Chengdu, 610041, People's Republic of China. kangpengd@163.com.""}]",International orthopaedics,['10.1007/s00264-020-04700-z'] 1120,32701665,Effects of pharmacologic and nonpharmacologic interventions on menopause-related quality of life: a pooled analysis of individual participant data from four MsFLASH trials.,"OBJECTIVE The Menopause Strategies: Finding Lasting Answers for Symptoms and Health network conducted three randomized clinical trials (RCTs) testing six interventions treating vasomotor symptoms (VMS), and also collected menopause-related quality of life (QOL) measures. A fourth RCT assessed an intervention for insomnia symptoms among women with VMS. We describe these seven interventions' effects on menopause-related QOL relative to control in women with VMS. METHODS We pooled individual-level data from 1,005 peri- and postmenopausal women with 14 or more VMS/week across the four RCTs. Interventions included escitalopram 10 to 20 mg/d; yoga/aerobic exercise; 1.8 g/d omega-3-fatty acids; oral 17-beta-estradiol 0.5 mg/d; venlafaxine XR 75 mg/d; and cognitive behavioral therapy for insomnia (CBT-I). Outcomes measures were the Menopause-specific Quality of Life scale and its subscales. RESULTS Significant improvements in total Menopause-specific Quality of Life from baseline were observed with estradiol, escitalopram, CBT-I, and yoga, with mean decreases of 0.3 to 0.5 points relative to control. The largest improvement in the vasomotor subscale was observed with estradiol (-1.2 points), with more modest but significant effects seen with escitalopram, yoga, and CBT-I. Significant improvements in the psychosocial subscale were observed for escitalopram, venlafaxine, and CBT-I. For the physical subscale, the greatest improvement was observed for CBT-I and exercise, whereas for the sexual subscale, the greatest improvement was observed for CBT-I, with yoga and estradiol demonstrating smaller effects. CONCLUSIONS These results suggest that for menopause-related QOL, women have a variety of treatment strategies to choose from and can select an approach based on most bothersome symptoms and individual preferences.",2020,"RESULTS Significant improvements in total Menopause-specific Quality of Life from baseline were observed with estradiol, escitalopram, CBT-I, and yoga, with mean decreases of 0.3 to 0.5 points relative to control.","['1,005 peri- and postmenopausal women with 14 or more VMS/week across the four RCTs', 'women with VMS']","['escitalopram 10 to 20\u200amg/d; yoga/aerobic exercise; 1.8\u200ag/d omega-3-fatty acids; oral 17-beta-estradiol 0.5\u200amg/d; venlafaxine XR 75\u200amg/d; and cognitive behavioral therapy', 'venlafaxine', 'pharmacologic and nonpharmacologic interventions']","['vasomotor subscale', 'Menopause-specific Quality of Life scale and its subscales', 'menopause-related quality of life', 'insomnia symptoms', 'total Menopause-specific Quality of Life', 'psychosocial subscale']","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.0397297,"RESULTS Significant improvements in total Menopause-specific Quality of Life from baseline were observed with estradiol, escitalopram, CBT-I, and yoga, with mean decreases of 0.3 to 0.5 points relative to control.","[{'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Diem', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Andrea Z', 'Initials': 'AZ', 'LastName': 'LaCroix', 'Affiliation': 'Department of Family Medicine and Public Health, University of California - San Diego, La Jolla, CA.'}, {'ForeName': 'Susan D', 'Initials': 'SD', 'LastName': 'Reed', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Washington, Seattle, WA.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Larson', 'Affiliation': 'Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Newton', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA.'}, {'ForeName': 'Kristine E', 'Initials': 'KE', 'LastName': 'Ensrud', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Nancy F', 'Initials': 'NF', 'LastName': 'Woods', 'Affiliation': 'School of Nursing, University of Washington, Seattle, WA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Guthrie', 'Affiliation': 'Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001597'] 1121,32727231,Skin preparation type and post-cesarean infection with use of adjunctive azithromycin prophylaxis.,"OBJECTIVE To compare the frequency of postoperative surgical site infection (SSI) by type of skin preparation used for unscheduled cesarean in the setting of adjunctive azithromycin prophylaxis. METHODS Secondary analysis of a multi-center randomized controlled trial of adjunctive azithromycin (500 mg intravenous) versus placebo in women who were ≥24 weeks gestation and undergoing unscheduled cesarean (i.e. during labor or ≥4 h after membrane rupture). Type of skin preparation used was identified based on the protocol at the hospital at the time of delivery: iodine-alcohol, chlorhexidine, chlorhexidine-alcohol, or the combination of chlorhexidine-alcohol and iodine. The primary outcome of this analysis was incidence of post-operative SSI, as defined by CDC criteria. Multivariable logistic regression was applied for adjustments. RESULTS All 2013 women in the primary trial were included in this analysis. Women were grouped according to type of skin preparation received: iodine-alcohol ( n  = 193), chlorhexidine ( n  = 733), chlorhexidine-alcohol ( n  = 656), and chlorhexidine-alcohol and iodine combined sequentially ( n  = 431). The unadjusted rates of wound infection ranged from 2.9% to 5.7%. Using iodine-alcohol as the referent, the adjusted odds ratios for wound SSI were 0.71 (95% CI 0.30-1.66) for chlorhexidine, 0.97 (95% CI 0.41-2.28) for chlorhexidine-alcohol, and 0.88 (95% CI 0.36-2.20) for chlorhexidine-alcohol with iodine combination. CONCLUSION In women undergoing unscheduled cesarean delivery in a trial of adjunctive azithromycin, the type of skin preparation used did not appear to be associated with the frequency of wound SSI.",2020,"Using iodine-alcohol as the referent, the adjusted odds ratios for wound SSI were 0.71 (95% CI 0.30-1.66) for chlorhexidine, 0.97 (95% CI 0.41-2.28) for chlorhexidine-alcohol, and 0.88 (95% CI 0.36-2.20) for chlorhexidine-alcohol with iodine combination. ","['women undergoing unscheduled cesarean delivery in a trial of', 'All 2013 women in the primary trial', 'women who were ≥24\u2009weeks gestation and undergoing unscheduled cesarean (i.e. during labor or ≥4\u2009h after membrane rupture']","['adjunctive azithromycin prophylaxis', 'adjunctive azithromycin', 'chlorhexidine-alcohol and iodine combined sequentially', 'chlorhexidine', 'iodine-alcohol', 'chlorhexidine-alcohol with iodine combination', 'iodine-alcohol, chlorhexidine, chlorhexidine-alcohol, or the combination of chlorhexidine-alcohol and iodine', 'chlorhexidine-alcohol', 'placebo']","['adjusted odds ratios for wound SSI', 'incidence of post-operative SSI, as defined by CDC criteria', 'unadjusted rates of wound infection', 'frequency of wound SSI']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0233308', 'cui_str': 'Spontaneous rupture of fetal membranes'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0332803', 'cui_str': 'Surgical wound'}, {'cui': 'C0578491', 'cui_str': 'Infection by site'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0007670', 'cui_str': 'Centers for Disease Control and Prevention (U.S.)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",,0.0893631,"Using iodine-alcohol as the referent, the adjusted odds ratios for wound SSI were 0.71 (95% CI 0.30-1.66) for chlorhexidine, 0.97 (95% CI 0.41-2.28) for chlorhexidine-alcohol, and 0.88 (95% CI 0.36-2.20) for chlorhexidine-alcohol with iodine combination. ","[{'ForeName': 'Elizabeth B', 'Initials': 'EB', 'LastName': 'Ausbeck', 'Affiliation': ""Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, AL, USA.""}, {'ForeName': 'Victoria C', 'Initials': 'VC', 'LastName': 'Jauk', 'Affiliation': ""Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, AL, USA.""}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Boggess', 'Affiliation': 'Department of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Saade', 'Affiliation': 'The University of Texas Medical Branch, Galveston, TX, USA.'}, {'ForeName': 'Sherri', 'Initials': 'S', 'LastName': 'Longo', 'Affiliation': 'Department of Obstetrics and Gynecology, Ochsner Health System, New Orleans, LA, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Esplin', 'Affiliation': 'The University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Cleary', 'Affiliation': 'Department of Obstetrics and Gynecology, Columbia University, New York, NY, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Wapner', 'Affiliation': 'Department of Obstetrics and Gynecology, Columbia University, New York, NY, USA.'}, {'ForeName': 'Kellett', 'Initials': 'K', 'LastName': 'Letson', 'Affiliation': 'Mission Hospital, Asheville, NC, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Owens', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Mississippi, Jackson, MS, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Blackwell', 'Affiliation': 'Obstetrics, Gynecology and Reproductive Sciences, University of Texas Health Sciences Center, Houston, TX, USA.'}, {'ForeName': 'Namasivayam', 'Initials': 'N', 'LastName': 'Ambalavanan', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Jeff M', 'Initials': 'JM', 'LastName': 'Szychowski', 'Affiliation': ""Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, AL, USA.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Andrews', 'Affiliation': ""Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, AL, USA.""}, {'ForeName': 'Alan T N', 'Initials': 'ATN', 'LastName': 'Tita', 'Affiliation': ""Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, AL, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2020.1797665'] 1122,32734288,A patient-initiated DMARD self-monitoring service for people with rheumatoid or psoriatic arthritis: a cost-effectiveness analysis.,"OBJECTIVE To determine whether a patient-initiated DMARD self-monitoring service for people on MTX is a cost-effective model of care for patients with RA or PsA. METHODS An economic evaluation was undertaken alongside a randomized controlled trial involving 100 patients. Outcome measures were quality of life and ESR assessed at baseline and post-intervention. Costs were calculated for healthcare usage using a United Kingdom National Health Service economic perspective. Sensitivity analysis was performed to explore the impact of nurse-led telephone helplines. Uncertainty around the cost-effectiveness ratios was estimated by bootstrapping and analysing the cost-effectiveness planes. RESULTS Fifty-two patients received the intervention and 48 usual care. The difference in mean cost per case indicated that the intervention was £263 more expensive (P < 0.001; 95% CI: £149.14, £375.86) when the helpline costs were accounted for and £94 cheaper (P = 0.08; 95% CI: -£199.26, £10.41) when these costs were absorbed by the usual service. There were, however, statistically significant savings for the patient (P = 0.02; 95% CI: -£28.98, £3.00). When costs and effectiveness measures of ESR and quality of life measured, using the Short Form-12v1, were combined this did not show the patient-initiated service to be cost-effective at a statistically significant level. CONCLUSION This patient-initiated service led to reductions in primary and secondary healthcare services that translated into reduced costs, in comparison with usual care, but were not cost-effective. Further work is needed to establish how nurse-led telephone triage services are integrated into rheumatology services and the associated costs of setting up and delivering them. TRIAL REGISTRATION ClinicalTrials.gov, http://clinicaltrials.gov, ISRCTN21613721.",2021,"The difference in mean cost per case indicated that the intervention was £263 more expensive (P < 0.001; 95% CI: £149.14, £375.86) when the helpline costs were accounted for and £94 cheaper (P = 0.08; 95% CI: -£199.26, £10.41) when these costs were absorbed by the usual service.","['people with rheumatoid or psoriatic arthritis', '100 patients', 'patients with RA or PsA.\nMETHODS']",['MTX'],"['ESR and quality of life', 'cost-effectiveness ratios', 'helpline costs', 'quality of life and ESR', 'mean cost per case']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0013845', 'cui_str': 'Electron spin resonance measurement'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0868928', 'cui_str': 'Case'}]",100.0,0.206487,"The difference in mean cost per case indicated that the intervention was £263 more expensive (P < 0.001; 95% CI: £149.14, £375.86) when the helpline costs were accounted for and £94 cheaper (P = 0.08; 95% CI: -£199.26, £10.41) when these costs were absorbed by the usual service.","[{'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'McBain', 'Affiliation': 'School of Health Sciences, City, University of London.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Flood', 'Affiliation': 'School of Health and Social Care, London South Bank University.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Shipley', 'Affiliation': 'Department of Rheumatology, University College London Hospital, London, UK.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Olaleye', 'Affiliation': 'Department of Rheumatology, University College London Hospital, London, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Moore', 'Affiliation': 'Department of Rheumatology, University College London Hospital, London, UK.'}, {'ForeName': 'Stanton', 'Initials': 'S', 'LastName': 'Newman', 'Affiliation': 'School of Health and Social Care, London South Bank University.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa309'] 1123,33217361,"Safety and immunogenicity of a two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in adults in Europe (EBOVAC2): a randomised, observer-blind, participant-blind, placebo-controlled, phase 2 trial.","BACKGROUND To address the unmet medical need for an effective prophylactic vaccine against Ebola virus we assessed the safety and immunogenicity of three different two-dose heterologous vaccination regimens with a replication-deficient adenovirus type 26 vector-based vaccine (Ad26.ZEBOV), expressing Zaire Ebola virus glycoprotein, and a non-replicating, recombinant, modified vaccinia Ankara (MVA) vector-based vaccine, encoding glycoproteins from Zaire Ebola virus, Sudan virus, and Marburg virus, and nucleoprotein from the Tai Forest virus. METHODS This randomised, observer-blind, placebo-controlled, phase 2 trial was done at seven hospitals in France and two research centres in the UK. Healthy adults (aged 18-65 years) with no history of Ebola vaccination were enrolled into four cohorts. Participants in cohorts I-III were randomly assigned (1:1:1) using computer-generated randomisation codes into three parallel groups (randomisation for cohorts II and III was stratified by country and age), in which participants were to receive an intramuscular injection of Ad26.ZEBOV on day 1, followed by intramuscular injection of MVA-BN-Filo at either 28 days (28-day interval group), 56 days (56-day interval group), or 84 days (84-day interval group) after the first vaccine. Within these three groups, participants in cohort II (14:1) and cohort III (10:3) were further randomly assigned to receive either Ad26.ZEBOV or placebo on day 1, followed by either MVA-BN-Filo or placebo on days 28, 56, or 84. Participants in cohort IV were randomly assigned (5:1) to receive one dose of either Ad26.ZEBOV or placebo on day 1 for vector shedding assessments. For cohorts II and III, study site personnel, sponsor personnel, and participants were masked to vaccine allocation until all participants in these cohorts had completed the post-MVA-BN-Filo vaccination visit at 6 months or had discontinued the trial, whereas cohort I was open-label. For cohort IV, study site personnel and participants were masked to vaccine allocation until all participants in this cohort had completed the post-vaccination visit at 28 days or had discontinued the trial. The primary outcome, analysed in all participants who had received at least one dose of vaccine or placebo (full analysis set), was the safety and tolerability of the three vaccination regimens, as assessed by participant-reported solicited local and systemic adverse events within 7 days of receiving both vaccines, unsolicited adverse events within 42 days of receiving the MVA-BN-Filo vaccine, and serious adverse events over 365 days of follow-up. The secondary outcome was humoral immunogenicity, as measured by the concentration of Ebola virus glycoprotein-binding antibodies at 21 days after receiving the MVA-BN-Filo vaccine. The secondary outcome was assessed in the per-protocol analysis set. This study is registered at ClinicalTrials.gov, NCT02416453, and EudraCT, 2015-000596-27. FINDINGS Between June 23, 2015, and April 27, 2016, 423 participants were enrolled: 408 in cohorts I-III were randomly assigned to the 28-day interval group (123 to receive Ad26.ZEBOV and MVA-BN-Filo, and 13 to receive placebo), the 56-day interval group (124 to receive Ad26.ZEBOV and MVA-BN-Filo, and 13 to receive placebo), and the 84-day interval group (117 to receive Ad26.ZEBOV and MVA-BN-Filo, and 18 to receive placebo), and 15 participants in cohort IV were assigned to receive Ad26.ZEBOV and MVA-BN-Filo (n=13) or to receive placebo (n=2). 421 (99·5%) participants received at least one dose of vaccine or placebo. The trial was temporarily suspended after two serious neurological adverse events were reported, one of which was considered as possibly related to vaccination, and per-protocol vaccination was disrupted for some participants. Vaccinations were generally well tolerated. Mild or moderate local adverse events (mostly pain) were reported after 206 (62%) of 332 Ad26.ZEBOV vaccinations, 136 (58%) of 236 MVA-BN-Filo vaccinations, and 11 (15%) of 72 placebo injections. Systemic adverse events were reported after 255 (77%) Ad26.ZEBOV vaccinations, 116 (49%) MVA-BN-Filo vaccinations, and 33 (46%) placebo injections, and included mostly mild or moderate fatigue, headache, or myalgia. Unsolicited adverse events occurred after 115 (35%) of 332 Ad26.ZEBOV vaccinations, 81 (34%) of 236 MVA-BN-Filo vaccinations, and 24 (33%) of 72 placebo injections. At 21 days after receiving the MVA-BN-Filo vaccine, geometric mean concentrations of Ebola virus glycoprotein-binding antibodies were 4627 ELISA units (EU)/mL (95% CI 3649-5867) in the 28-day interval group, 10 131 EU/mL (8554-11 999) in the 56-day interval group, and 11 312 mL (9072-14106) in the 84-day interval group, with antibody concentrations persisting at 1149-1205 EU/mL up to day 365. INTERPRETATION The two-dose heterologous regimen with Ad26.ZEBOV and MVA-BN-Filo was safe, well tolerated, and immunogenic, with humoral and cellular immune responses persisting for 1 year after vaccination. Taken together, these data support the intended prophylactic indication for the vaccine regimen. FUNDING Innovative Medicines Initiative and Janssen Vaccines & Prevention BV. TRANSLATION For the French translation of the abstract see Supplementary Materials section.",2021,"Unsolicited adverse events occurred after 115 (35%) of 332 Ad26.ZEBOV vaccinations, 81 (34%) of 236 MVA-BN-Filo vaccinations, and 24 (33%) of 72 placebo injections.","['participants in cohort II (14:1) and cohort III (10:3', 'adults in Europe (EBOVAC2', 'Participants in cohorts', 'Healthy adults (aged 18-65 years) with no history of Ebola vaccination were enrolled into four cohorts', 'seven hospitals in France and two research centres in the UK', '423 participants were enrolled: 408 in cohorts I-III', 'Between June 23, 2015, and April 27, 2016', '15 participants in cohort IV']","['heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen', 'Ad26.ZEBOV and MVA-BN-Filo, and 13 to receive placebo), the 56-day interval group (124 to receive Ad26.ZEBOV and MVA-BN-Filo, and 13 to receive placebo), and the 84-day interval group (117 to receive Ad26.ZEBOV and MVA-BN-Filo, and 18 to receive placebo', 'placebo', 'Ad26.ZEBOV and MVA-BN-Filo (n=13) or to receive placebo', 'MVA-BN-Filo or placebo', 'vaccine or placebo', 'Ad26.ZEBOV or placebo']","['Systemic adverse events', 'solicited local and systemic adverse events', 'safety and tolerability', 'serious adverse events', 'Mild or moderate local adverse events (mostly pain', 'Safety and immunogenicity', 'Unsolicited adverse events', 'moderate fatigue, headache, or myalgia', 'humoral immunogenicity, as measured by the concentration of Ebola virus glycoprotein-binding antibodies', 'tolerated']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0282687', 'cui_str': 'Ebola virus disease'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4517769', 'cui_str': '408'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0439860', 'cui_str': 'Heterologous'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042214', 'cui_str': 'Vaccinia'}, {'cui': 'C1449556', 'cui_str': 'Ebolavirus Vaccines'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0949892', 'cui_str': 'Ebolavirus'}, {'cui': 'C0017968', 'cui_str': 'Glycoprotein'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]",423.0,0.596138,"Unsolicited adverse events occurred after 115 (35%) of 332 Ad26.ZEBOV vaccinations, 81 (34%) of 236 MVA-BN-Filo vaccinations, and 24 (33%) of 72 placebo injections.","[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Pollard', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Launay', 'Affiliation': 'Université de Paris, INSERM CIC 1417, F-CRIN I-REIVAC, Paris, France; Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, CIC Cochin Pasteur, Paris, France.'}, {'ForeName': 'Jean-Daniel', 'Initials': 'JD', 'LastName': 'Lelievre', 'Affiliation': 'Vaccine Research Institute, Faculté de Médecine, Université Paris-Est Créteil, INSERM U955, Créteil, France; Assistance Publique-Hôpitaux de Paris, Groupe Henri-Mondor Albert-Chenevier, Service Immunologie Clinique, Créteil, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lacabaratz', 'Affiliation': 'Vaccine Research Institute, Faculté de Médecine, Université Paris-Est Créteil, INSERM U955, Créteil, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Grande', 'Affiliation': 'Allergology and Clinical Immunology, LYREC, Lyon University Hospital, France.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Goldstein', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Robinson', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Auguste', 'Initials': 'A', 'LastName': 'Gaddah', 'Affiliation': 'Janssen Research and Development, Beerse, Belgium.'}, {'ForeName': 'Viki', 'Initials': 'V', 'LastName': 'Bockstal', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Aurelie', 'Initials': 'A', 'LastName': 'Wiedemann', 'Affiliation': 'Vaccine Research Institute, Faculté de Médecine, Université Paris-Est Créteil, INSERM U955, Créteil, France.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Leyssen', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Luhn', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Richert', 'Affiliation': 'University Bordeaux, INSERM, Bordeaux Population Health Research Center, UMR 1219, INSERM, CHU Bordeaux, Bordeaux, France; CIC, EUCLID/F-CRIN Clinical Trials Platform, F-33000, Bordeaux, France; Inria SISTM team, F-33405, Talence, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Bétard', 'Affiliation': 'University Bordeaux, INSERM, Bordeaux Population Health Research Center, UMR 1219, INSERM, CHU Bordeaux, Bordeaux, France; CIC, EUCLID/F-CRIN Clinical Trials Platform, F-33000, Bordeaux, France.'}, {'ForeName': 'Malick M', 'Initials': 'MM', 'LastName': 'Gibani', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Clutterbuck', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Snape', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Levy', 'Affiliation': 'Vaccine Research Institute, Faculté de Médecine, Université Paris-Est Créteil, INSERM U955, Créteil, France.'}, {'ForeName': 'Macaya', 'Initials': 'M', 'LastName': 'Douoguih', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Rodolphe', 'Initials': 'R', 'LastName': 'Thiebaut', 'Affiliation': 'University Bordeaux, INSERM, Bordeaux Population Health Research Center, UMR 1219, INSERM, CHU Bordeaux, Bordeaux, France; CIC, EUCLID/F-CRIN Clinical Trials Platform, F-33000, Bordeaux, France; Inria SISTM team, F-33405, Talence, France. Electronic address: rodolphe.thiebaut@u-bordeaux.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30476-X'] 1124,33221631,A 16-week randomized placebo-controlled trial investigating the effects of omega-3 polyunsaturated fatty acid treatment on white matter microstructure in recent-onset psychosis patients concurrently treated with risperidone.,"We examined the impact of treatment with fish oil (FO), a rich source of omega-3 polyunsaturated fatty acids (n-3 PUFA), on white matter in 37 recent-onset psychosis patients receiving risperidone in a double-blind placebo-controlled randomized clinical trial. Patients were scanned at baseline and randomly assigned to receive 16-weeks of treatment with risperidone + FO or risperidone + placebo. Eighteen patients received follow-up MRIs (FO, n = 10/Placebo, n = 8). Erythrocyte levels of n-3 PUFAs eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and docosapentaenoic acid (DPA) were obtained at both time points. We employed Free Water Imaging metrics representing the extracellular free water fraction (FW) and fractional anisotropy of the tissue (FA-t). Analyses were conducted using Tract-Based-Spatial-Statistics and nonparametric permutation-based tests with family-wise error correction. There were significant positive correlations of FA-t with DHA and DPA among all patients at baseline. Patients treated with risperidone + placebo demonstrated reductions in FA-t and increases in FW, whereas patients treated with risperidone + FO exhibited no significant changes in FW and FA-t reductions were largely attenuated. The correlations of DPA and DHA with baseline FA-t support the hypothesis that n-3 PUFA intake or biosynthesis are associated with white matter abnormalities in psychosis. Adjuvant FO treatment may partially mitigate against white matter alterations observed in recent-onset psychosis patients following risperidone treatment.",2021,"Patients treated with risperidone + placebo demonstrated reductions in FA-t and increases in FW, whereas patients treated with risperidone + FO exhibited no significant changes in FW and FA-t reductions were largely attenuated.","['37 recent-onset psychosis patients receiving', 'white matter microstructure in recent-onset psychosis patients concurrently treated with']","['placebo', 'risperidone + FO or risperidone + placebo', 'omega-3 polyunsaturated fatty acid treatment', 'risperidone + placebo', 'risperidone + FO', 'fish oil (FO), a rich source of omega-3 polyunsaturated fatty acids (n-3 PUFA', 'risperidone']","['Erythrocyte levels of n-3 PUFAs eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and docosapentaenoic acid (DPA', 'FW and FA-t reductions', 'FA-t and increases in FW']","[{'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0449416', 'cui_str': 'Source'}]","[{'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0058624', 'cui_str': 'docosapentaenoic acid'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",,0.260786,"Patients treated with risperidone + placebo demonstrated reductions in FA-t and increases in FW, whereas patients treated with risperidone + FO exhibited no significant changes in FW and FA-t reductions were largely attenuated.","[{'ForeName': 'Amanda E', 'Initials': 'AE', 'LastName': 'Lyall', 'Affiliation': ""Psychiatry Neuroimaging Laboratory, Department of Psychiatry, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States; Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States. Electronic address: alyall@bwh.harvard.edu.""}, {'ForeName': 'Felix L', 'Initials': 'FL', 'LastName': 'Nägele', 'Affiliation': ""Psychiatry Neuroimaging Laboratory, Department of Psychiatry, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States; Psychiatry Neuroimaging Branch, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, University of Hamburg, Hamburg, Germany.""}, {'ForeName': 'Ofer', 'Initials': 'O', 'LastName': 'Pasternak', 'Affiliation': ""Psychiatry Neuroimaging Laboratory, Department of Psychiatry, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States; Department of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States.""}, {'ForeName': 'Juan A', 'Initials': 'JA', 'LastName': 'Gallego', 'Affiliation': 'Departments of Psychiatry and of Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, United States; Feinstein Institutes for Medical Research, Manhasset, NY, United States.'}, {'ForeName': 'Anil K', 'Initials': 'AK', 'LastName': 'Malhotra', 'Affiliation': 'Departments of Psychiatry and of Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, United States; Feinstein Institutes for Medical Research, Manhasset, NY, United States.'}, {'ForeName': 'Robert K', 'Initials': 'RK', 'LastName': 'McNamara', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, Lipidomics Research Program, University of Cincinnati, United States.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Kubicki', 'Affiliation': ""Psychiatry Neuroimaging Laboratory, Department of Psychiatry, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States; Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States; Department of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States.""}, {'ForeName': 'Bart D', 'Initials': 'BD', 'LastName': 'Peters', 'Affiliation': 'Feinstein Institutes for Medical Research, Manhasset, NY, United States.'}, {'ForeName': 'Delbert G', 'Initials': 'DG', 'LastName': 'Robinson', 'Affiliation': 'Departments of Psychiatry and of Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, United States; Feinstein Institutes for Medical Research, Manhasset, NY, United States.'}, {'ForeName': 'Philip R', 'Initials': 'PR', 'LastName': 'Szeszko', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, United States; Mental Illness Research, Education and Clinical Center, James J. Peters VA Medical Center, Bronx, NY, United States.'}]",Psychiatry research. Neuroimaging,['10.1016/j.pscychresns.2020.111219'] 1125,33223049,Reply to Comment on: Posterior Capsule Opacification With Two Hydrophobic Acrylic Intraocular Lenses: 3-Year Results of a Randomized Trial.,,2021,,[],['Posterior Capsule Opacification With Two Hydrophobic Acrylic Intraocular Lenses'],[],[],"[{'cui': 'C1444680', 'cui_str': 'Posterior capsule opacification'}, {'cui': 'C0598629', 'cui_str': 'Hydrophobicity'}, {'cui': 'C0440181', 'cui_str': 'Acrylic dental material'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}]",[],,0.0499483,,"[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Leydolt', 'Affiliation': 'Vienna, Austria.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Menapace', 'Affiliation': 'Vienna, Austria.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.08.015'] 1126,33231679,"Evaluating a child care-based social marketing approach for improving children's diet and physical activity: results from the Healthy Me, Healthy We cluster-randomized controlled trial.","Child care-based interventions offer an opportunity to reach children at a young and impressionable age to support healthy eating and physical activity behaviors. Ideally, these interventions engage caregivers, including both childcare providers and parents, in united effort. This study evaluated the impact of the Healthy Me, Healthy We intervention on children's diet quality and physical activity. A sample of 853 three- to four-year-old children from 92 childcare centers were enrolled in this cluster-randomized control trial. Healthy Me, Healthy We was an 8-month, social marketing intervention delivered through childcare that encouraged caregivers (childcare providers and parents) to use practices that supported children's healthy eating and physical activity behaviors. Outcome measures, collected at baseline and post-intervention, assessed children's diet quality, physical activity, and BMI as well as caregivers' feeding and physical activity practices. Generalized Linear Mixed Models were used to assess change from baseline to post-intervention between intervention and control arms. No significant changes were noted in any of the outcome measures except for small improvements in children's sodium intake and select parent practices. Despite the negative findings, this study offers many lessons about the importance and challenges of effective parent engagement which is critical for meaningful changes in children's health behaviors.",2021,No significant changes were noted in any of the outcome measures except for small improvements in children's sodium intake and select parent practices.,"['A sample of 853 three- to four-year-old children from 92 childcare centers', ""children's diet and physical activity""]","['Child care-based interventions', ""social marketing intervention delivered through childcare that encouraged caregivers (childcare providers and parents) to use practices that supported children's healthy eating and physical activity behaviors"", 'child care-based social marketing approach']","[""children's sodium intake and select parent practices"", ""children's diet quality, physical activity, and BMI as well as caregivers' feeding and physical activity practices"", ""children's diet quality and physical activity""]","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0008067', 'cui_str': 'Puericulture'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0037424', 'cui_str': 'Social Marketing'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]",,0.0557,No significant changes were noted in any of the outcome measures except for small improvements in children's sodium intake and select parent practices.,"[{'ForeName': 'Amber E', 'Initials': 'AE', 'LastName': 'Vaughn', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Hennink-Kaminski', 'Affiliation': 'School of Media and Journalism, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Moore', 'Affiliation': 'Biostats Collaboration Core, Emory University, Atlanta, GA.'}, {'ForeName': 'Regan', 'Initials': 'R', 'LastName': 'Burney', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Jesse L', 'Initials': 'JL', 'LastName': 'Chittams', 'Affiliation': 'Biostatistics Consulting Unit, Office of Nursing Research, School of Nursing, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Portia', 'Initials': 'P', 'LastName': 'Parker', 'Affiliation': 'SAS Institute Inc., Cary, NC.'}, {'ForeName': 'Courtney T', 'Initials': 'CT', 'LastName': 'Luecking', 'Affiliation': 'Department of Dietetics and Human Nutrition, College of Agriculture, Food and Environment, University of Kentucky, Lexington, KY.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Hales', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Dianne S', 'Initials': 'DS', 'LastName': 'Ward', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}]",Translational behavioral medicine,['10.1093/tbm/ibaa113'] 1127,32692121,The Effects of Shared Decision Making on Different Renal Replacement Therapy Decisions in Patients With Chronic Kidney Disease.,"BACKGROUND The prevalence and incidence of end-stage renal disease (ESRD) in Taiwan are the highest of any country in the world. The different renal replacement therapies that are adopted by patients with ESRD significantly affect their social roles and daily life. However, because of the complexities of different renal replacement therapies, patients may be unsure of which to choose. PURPOSE The aim of this study was to explore the effectiveness of a shared decision-making (SDM) program regarding different renal replacement therapies for patients with chronic kidney disease. METHODS A quasi-experimental design was conducted at two similar regional hospitals in Miaoli County, Taiwan. One hospital hosted the intervention group, and the other hospital hosted the control group. The 31 participants in the intervention group took part in a SDM program. The 36 control group participants took part in the pre-ESRD care program. Data collection included demographic and disease characteristics, decisional conflict scale, and decision self-efficacy scale. Results were analyzed using independent t test, Fisher's exact test, generalized estimating equation, and paired t tests. RESULTS The study results revealed that the intervention group experienced a significant increase in decision self-efficacy and a significant decrease in decisional conflict at 1 month after receiving the SDM intervention in comparison to before and immediately after receiving the intervention. Moreover, the intervention group had higher decision self-efficacy and lower decisional conflict than the control group. CONCLUSIONS/IMPLICATIONS FOR PRACTICE The SDM program may be an effective intervention for complex decision-making processes, such as the process involved in making renal replacement treatment decisions. The SDM program group intervention improved decisional conflict and decision self-efficacy. Thus, to improve patients' decision-making processes, the application of an SDM program focused on the personal values and opinions of patients with ESRD will be necessary. Physicians and case managers of patients with ESRD should act in complementary and cooperative roles in SDM programs.",2020,"Moreover, the intervention group had higher decision self-efficacy and lower decisional conflict than the control group. ","['A quasi-experimental design was conducted at two similar regional hospitals in Miaoli County, Taiwan', 'Patients With Chronic Kidney Disease', 'Physicians and case managers of patients with ESRD', '31 participants in the intervention group took part in a SDM program', 'patients with chronic kidney disease']","['SDM intervention', 'shared decision-making (SDM) program']","['higher decision self-efficacy and lower decisional conflict', 'social roles and daily life', 'decisional conflict and decision self-efficacy', 'decision self-efficacy', 'demographic and disease characteristics, decisional conflict scale, and decision self-efficacy scale', 'decisional conflict']","[{'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0687694', 'cui_str': 'Case manager'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0143736,"Moreover, the intervention group had higher decision self-efficacy and lower decisional conflict than the control group. ","[{'ForeName': 'Ya-Fang', 'Initials': 'YF', 'LastName': 'Ho', 'Affiliation': 'PhD, RN, Assistant Professor, School of Nursing & Graduate Institute of Nursing, China Medical University, Taiwan, ROC.'}, {'ForeName': 'Yu-Chi', 'Initials': 'YC', 'LastName': 'Chen', 'Affiliation': 'PhD, RN, Associate Professor, Institute of Clinical Nursing, School of Nursing, National Yang-Ming University, Taiwan, ROC.'}, {'ForeName': 'Chiu-Chin', 'Initials': 'CC', 'LastName': 'Huang', 'Affiliation': 'MD, Chair Professor, China Medical University Hospital, Taiwan, ROC.'}, {'ForeName': 'Wen-Yu', 'Initials': 'WY', 'LastName': 'Hu', 'Affiliation': 'PhD, RN, Professor, School and Graduate Institute of Nursing, College of Medicine, National Taiwan University, and Director, Nursing Department, National Taiwan University Hospital, Taiwan, ROC.'}, {'ForeName': 'Kuan-Chia', 'Initials': 'KC', 'LastName': 'Lin', 'Affiliation': 'PhD, Professor, Institute of Hospital and Health Care Administration, Community Medicine Research Center, Preventive Medicine Research Center, National Yang-Ming University, Taiwan, ROC.'}, {'ForeName': 'I-Chuan', 'Initials': 'IC', 'LastName': 'Li', 'Affiliation': 'PhD, RN, Professor, Institute of Community Health Care, National Yang-Ming University, Taiwan, ROC.'}]",The journal of nursing research : JNR,['10.1097/jnr.0000000000000386'] 1128,32699904,Efficacy and safety of Sandoz biosimilar rituximab for active rheumatoid arthritis: 52-week results from the randomized controlled ASSIST-RA trial.,"OBJECTIVES This report provides data for the extent of B cell depletion and recovery, efficacy, safety and immunogenicity of Sandoz rituximab (SDZ-RTX; GP2013; Rixathon®) compared with reference rituximab (Ref-RTX) up to week 52 of the ASSIST-RA study. METHODS Patients were randomized to SDZ-RTX or Ref-RTX in combination with methotrexate according to the RTX label. The primary endpoint was analysed at week 24. Responders (28-joint DAS [DAS28] decrease from baseline >1.2) at week 24 with residual disease activity (DAS28 ≥2.6) were eligible for a second treatment course between week 24 and 52. Endpoints after week 24 included change from baseline in peripheral B cells, DAS28, ACR 20% response rate (ACR20), Clinical and Simplified Disease Activity Indexes (CDAI, SDAI) and HAQ disability index (HAQ-DI). Safety and immunogenicity were assessed by the incidence of adverse events and antidrug antibodies. RESULTS Primary and secondary endpoints up to week 24 were met. Overall, 260/312 randomized patients completed treatment up to week 52. SDZ-RTX resulted in B cell concentrations over time similar to Ref-RTX. The efficacy of SDZ-RTX was similar to Ref-RTX up to week 52, as measured by DAS28, ACR20/50/70, CDAI, SDAI and HAQ-DI. Safety of SDZ-RTX was similar to Ref-RTX regarding frequency, type and severity of adverse events, which were consistent with the known Ref-RTX safety profile. The incidence of antidrug antibodies was low and transient similarly across treatment groups. CONCLUSION SDZ-RTX demonstrated similar B cell concentrations over time, efficacy, safety and immunogenicity to Ref-RTX over 52 weeks of the ASSIST-RA study.",2021,"Safety of SDZ-RTX was similar to Ref-RTX regarding frequency, type and severity of adverse events, which were consistent with the known Ref-RTX safety profile.","['active rheumatoid arthritis', 'Patients']","['SDZ-RTX or Ref-RTX in combination with methotrexate', 'reference rituximab (Ref-RTX', 'SDZ-RTX', 'Sandoz rituximab (SDZ-RTX; GP2013; Rixathon®', 'Sandoz biosimilar rituximab']","['incidence of antidrug antibodies', 'Safety and immunogenicity', 'adverse events and antidrug antibodies', 'B cell concentrations', 'efficacy, safety and immunogenicity', 'Efficacy and safety', 'peripheral B cells, DAS28, ACR 20% response rate (ACR20), Clinical and Simplified Disease Activity Indexes (CDAI, SDAI) and HAQ disability index (HAQ-DI']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C4046044', 'cui_str': 'GP2013'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0102923', 'cui_str': 'ametantrone'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",,0.132052,"Safety of SDZ-RTX was similar to Ref-RTX regarding frequency, type and severity of adverse events, which were consistent with the known Ref-RTX safety profile.","[{'ForeName': 'Josef S', 'Initials': 'JS', 'LastName': 'Smolen', 'Affiliation': 'Department of Rheumatology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Stanley B', 'Initials': 'SB', 'LastName': 'Cohen', 'Affiliation': 'Department of Rheumatology, Metroplex Clinical Research Center, Dallas, TX, USA.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Tony', 'Affiliation': 'Department of Internal Medicine, Rheumatology/Clinical Immunology, University Hospital of Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'Morton', 'Initials': 'M', 'LastName': 'Scheinberg', 'Affiliation': 'Rheumatology Section, Orthopedic Department, Hospital Israelita Albert Einstein, Sao Paulo, Brazil.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Kivitz', 'Affiliation': 'Altoona Center for Clinical Research, Altoona Arthritis and Osteoporosis Center, Duncansville, PA, USA.'}, {'ForeName': 'Andra', 'Initials': 'A', 'LastName': 'Balanescu', 'Affiliation': 'Sf. Maria Hospital, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Gomez-Reino', 'Affiliation': 'Fundacion IDIS, Hospital Clinico Universitario, Santiago, Spain.'}, {'ForeName': 'Liyi', 'Initials': 'L', 'LastName': 'Cen', 'Affiliation': 'Biostatistics Biosimilars Analytics, Novartis Pharmaceuticals Corp,\xa0East Hanover, NJ, USA.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Poetzl', 'Affiliation': 'Biosimilar Clinical Development, Hexal AG, Holzkirchen, Germany.'}, {'ForeName': 'Tamas', 'Initials': 'T', 'LastName': 'Shisha', 'Affiliation': 'Translational Medicine, Novartis Institute of Biomedical Research, Basel, Switzerland.'}, {'ForeName': 'Dmitrij', 'Initials': 'D', 'LastName': 'Kollins', 'Affiliation': 'Biosimilar Clinical Development, Hexal AG, Holzkirchen, Germany.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa234'] 1129,32699906,"Effects of MOPP Gear on SAM Medical Junctional Tourniquet Application: A Prospective, Randomized Control Trial.","INTRODUCTION Hemorrhage is the leading cause of preventable death on the battlefield, and hemostasis is particularly challenging to achieve at junctional sites such as the axillary or inguinal regions. Mission-oriented protective posture (MOPP) gear, as worn most recently in Syria to guard against chemical weapons, can make the performance of technical skills more challenging still. The objective of this study was to evaluate how wearing MOPP gear affects the application time of the SAM Medical Junctional Tourniquet (SJT) by U.S. Army combat medics. MATERIALS AND METHODS We conducted a prospective, randomized control trial evaluating time for SJT application between participants wearing MOPP versus those not wearing MOPP. Secondary outcomes included SJT application success rate and participant appraisal of SJT application difficulty assessed with five-point Likert items, between groups. Participants placed SJTs on robotic simulation mannequins with a penetrating inguinal injury. RESULTS In April 2019, we enrolled 49 combat medics. Most participants were male (77.5%), had a median age of 25 (interquartile range 23-28), and in the grade of E4 or less (63.3%). Mean SJT application times in seconds were higher among those wearing MOPP versus those who were not (223.1 versus 167.2; 95% confidence interval for difference in means 5.293, 106.374; P = 0.03). Participants wearing MOPP had a less successful application rate overall, but this difference was not statistically significant (64.3% versus 81.0%, P = 0.34). Compared to participants not wearing MOPP, those wearing MOPP agreed that SJT application was difficult (4 versus 3, P = 0.03), what they were wearing affected SJT application (4 versus 2, P = 0.01), and it was difficult to use their hands during SJT application (4 versus 1, P < 0.001). CONCLUSIONS Wearing military MOPP gear significantly prolongs the amount of time required for combat medics to apply an SJT on a simulated casualty with a penetrating inguinal injury. This study highlights the importance of incorporating MOPP gear into medical training scenarios to improve skills competency while wearing these protective garments.",2020,"Participants wearing MOPP had a less successful application rate overall, but this difference was not statistically significant (64.3% versus 81.0%, P = 0.34).","['SAM Medical Junctional Tourniquet Application', 'participants wearing MOPP versus those not wearing MOPP', 'Most participants were male (77.5%), had a median age of 25 (interquartile range 23-28), and in the grade of E4 or less (63.3']","['SAM Medical Junctional Tourniquet (SJT', 'MOPP Gear', 'Mission-oriented protective posture (MOPP']","['SJT application success rate and participant appraisal of SJT application difficulty assessed with five-point Likert items', 'Mean SJT application times', 'successful application rate overall']","[{'cui': 'C0036002', 'cui_str': 'S-Adenosylmethionine'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0204731', 'cui_str': 'Application of tourniquet'}, {'cui': 'C0026219', 'cui_str': 'Missions'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]","[{'cui': 'C0036002', 'cui_str': 'S-Adenosylmethionine'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0026219', 'cui_str': 'Missions'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}]","[{'cui': 'C0036002', 'cui_str': 'S-Adenosylmethionine'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0204731', 'cui_str': 'Application of tourniquet'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.084364,"Participants wearing MOPP had a less successful application rate overall, but this difference was not statistically significant (64.3% versus 81.0%, P = 0.34).","[{'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Wagner', 'Affiliation': 'Madigan Army Medical Center, 9040A Jackson Ave, Joint Base Lewis-McChord, Tacoma, WA 98431.'}, {'ForeName': 'Jason F', 'Initials': 'JF', 'LastName': 'Naylor', 'Affiliation': 'Madigan Army Medical Center, 9040A Jackson Ave, Joint Base Lewis-McChord, Tacoma, WA 98431.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Ahern', 'Affiliation': 'Madigan Army Medical Center, 9040A Jackson Ave, Joint Base Lewis-McChord, Tacoma, WA 98431.'}, {'ForeName': 'Brett C', 'Initials': 'BC', 'LastName': 'Gendron', 'Affiliation': 'Brooke Army Medical Center, 3551 Roger Brooke Dr, Joint Base San Antonio-Fort Sam Houston, TX 78234.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'April', 'Affiliation': 'Uniformed Services University of the Health Sciences, 4301 Jones Bridge Rd, Bethesda, MD 20814.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Schauer', 'Affiliation': 'Brooke Army Medical Center, 3551 Roger Brooke Dr, Joint Base San Antonio-Fort Sam Houston, TX 78234.'}]",Military medicine,['10.1093/milmed/usaa138'] 1130,32706442,Effects of eccentric training at long-muscle length on architectural and functional characteristics of the hamstrings.,"Hamstring strain injuries during sprinting or stretching frequently occur at long-muscle length. Yet, previous research has mainly focused on studying the effectiveness of eccentric hamstring strengthening at shorter muscle length on hamstring performance, morphology, and hamstring strain injury risk factors. Here, we evaluated the effects of 6-week eccentric hamstring training at long-muscle length on functional and architectural characteristics of the hamstrings. Healthy and injury-free participants (n = 40; age 23.7 ± 2.5 years) were randomly assigned to control or intervention group. Training intervention consisted of 12 sessions with two eccentric hamstring exercises in a lengthened position. Outcome measures included isokinetic and isometric knee flexion peak torque, Nordic hamstring exercise peak torque, voluntary activation level, and countermovement jump performance. Ultrasonography was used to determine muscle thickness, pennation angle, and fascicle length of biceps femoris long head (BFlh). A significant time × group interaction effect was observed for all measured parameters except countermovement jump performance and muscle thickness. The training intervention resulted in increased concentric and eccentric knee flexion peak torque at 60°/s (d = 0.55-0.62, P = .02 and .03) and concentric peak torque at 180°/s (d = 0.99, P = .001), increased isometric knee flexion peak torque (d = 0.73, P = .008) and Nordic hamstring exercise peak torque (d = 1.19, P < .001), increased voluntary activation level (d = 1.29, P < .001), decreased pennation angle (d = 1.31, P < .001), and increased fascicle length (d = 1.12, P < .001) of BFlh. These results provide evidence that short-term eccentric hamstring strengthening at long-muscle length can have significant favorable effects on various architectural and functional characteristics of the hamstrings.",2020,"The training intervention resulted in increased concentric and eccentric knee flexion peak torque at 60°/s (d=0.55-0.62, p=0.02 and 0.03) and concentric peak torque at 180°/s",['Healthy and injury-free participants (n=40; age 23.7±2.5 years'],"['eccentric training', 'eccentric hamstring training', 'eccentric hamstring exercises', 'Ultrasonography']","['fascicle length', 'isokinetic and isometric knee flexion peak torque, Nordic hamstring exercise peak torque, voluntary activation level, and countermovement jump performance', 'muscle thickness, pennation angle and fascicle length of biceps femoris long head (BFlh', 'decreased pennation angle', 'concentric peak torque', 'isometric knee flexion peak torque', 'Nordic hamstring exercise peak torque', 'countermovement jump performance and muscle thickness', 'Hamstring strain injuries', 'voluntary activation level', 'concentric and eccentric knee flexion peak torque']","[{'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0224449', 'cui_str': 'Biceps femoris muscle structure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}]",,0.034489,"The training intervention resulted in increased concentric and eccentric knee flexion peak torque at 60°/s (d=0.55-0.62, p=0.02 and 0.03) and concentric peak torque at 180°/s","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Marušič', 'Affiliation': 'Faculty of Health Sciences, University of Primorska, Izola, Slovenia.'}, {'ForeName': 'Rok', 'Initials': 'R', 'LastName': 'Vatovec', 'Affiliation': 'Faculty of Health Sciences, University of Primorska, Izola, Slovenia.'}, {'ForeName': 'Goran', 'Initials': 'G', 'LastName': 'Marković', 'Affiliation': 'Faculty of Kinesiology, University of Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Nejc', 'Initials': 'N', 'LastName': 'Šarabon', 'Affiliation': 'Faculty of Health Sciences, University of Primorska, Izola, Slovenia.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13770'] 1131,32707246,Integrating colocated behavioral health care into a dermatology clinic: A prospective randomized controlled treatment pilot study in patients with alopecia areata.,,2021,,['Patients with Alopecia Areata'],['Integrating Co-located Behavioral Healthcare'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]",[],,0.0112644,,"[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Gorbatenko-Roth', 'Affiliation': 'University of Wisconsin-Stout, Department of Psychology, Menomonie, Wisconsin; University of Minnesota, Department of Dermatology, Minneapolis, Minnesota. Electronic address: gorbatenkok@uwstout.edu.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Hodges', 'Affiliation': 'Division of Biostatistics, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Dayna', 'Initials': 'D', 'LastName': 'Lifson', 'Affiliation': 'M Health Fairview, Minneapolis, Minnesota.'}, {'ForeName': 'Maribeth', 'Initials': 'M', 'LastName': 'Golm', 'Affiliation': 'University of Minnesota, Department of Dermatology, Minneapolis, Minnesota.'}, {'ForeName': 'Dory', 'Initials': 'D', 'LastName': 'Kranz', 'Affiliation': 'National Alopecia Areata Foundation, San Rafael, California.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Windenburg', 'Affiliation': 'University of Minnesota, Department of Dermatology, Minneapolis, Minnesota.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hordinsky', 'Affiliation': 'University of Minnesota, Department of Dermatology, Minneapolis, Minnesota.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.07.070'] 1132,32714972,The Effect of Selected Exercise Programs on the Quality of Life in Women with Grade 1 Stress Urinary Incontinence and Its Relationship with Various Body Mass Indices: A Randomized Trial.,"Aims The aim of the study was to analyze the influence gymnastics has on the quality of life (QOL) in women with grade 1 stress urinary incontinence (SUI) and to determine the relationship between the outcome and selected body weight indices: body mass index (BMI) and waist-to-hip ratio (WHR). Methods A randomized study of 140 women (45-60 years) with grade 1 SUI. The subjects were randomly assigned to a 3-month training for pelvic floor muscles and a transverse abdominal muscle (PFM + TrA, n = 70) or PFM alone ( n = 70). The QOL was determined with the questionnaire International Consultation on Incontinence Modular Questionnaire-Lower Urinary Tract Symptoms Quality of Life (ICIQ LUTS QOL), before and after the program. Results Women with BMI < 30 kg/m 2 benefited more from the PFM + TrA program with respect to physical limitations and embarrassment domains, whereas patients with a gynoid body type (WHR < 0.8) benefited more in terms of physical and social limitations, SUI-evoked emotions, severity measures, and embarrassment domains. Conclusions After the PFM + TrA training, women with WHR < 0.8 had a better QOL than those with WHR > 0.8.",2020,"kg/m 2 benefited more from the PFM + TrA program with respect to physical limitations and embarrassment domains, whereas patients with a gynoid body type (WHR < 0.8) benefited more in terms of physical and social limitations, SUI-evoked emotions, severity measures, and embarrassment domains. ","['140 women (45-60 years) with grade 1 SUI', 'Women with BMI < 30', 'women with grade 1 stress urinary incontinence (SUI', 'Women with Grade 1 Stress Urinary Incontinence and Its Relationship with Various Body Mass Indices']","['3-month training for pelvic floor muscles and a transverse abdominal muscle (PFM\u2009+\u2009TrA, n = 70) or PFM alone', 'Selected Exercise Programs']","['Quality of Life', 'Incontinence Modular Questionnaire-Lower Urinary Tract Symptoms Quality of Life (ICIQ LUTS QOL', 'quality of life (QOL', 'mass index (BMI) and waist-to-hip ratio (WHR', 'physical and social limitations, SUI-evoked emotions, severity measures, and embarrassment domains']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0224378', 'cui_str': 'Structure of transversus abdominis muscle'}, {'cui': 'C1868598', 'cui_str': 'Enlarged parietal foramina'}, {'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0679112', 'cui_str': 'Embarrassment'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",140.0,0.0601173,"kg/m 2 benefited more from the PFM + TrA program with respect to physical limitations and embarrassment domains, whereas patients with a gynoid body type (WHR < 0.8) benefited more in terms of physical and social limitations, SUI-evoked emotions, severity measures, and embarrassment domains. ","[{'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Ptak', 'Affiliation': 'Department of Medical Rehabilitation and Clinical Physiotherapy, Pomeranian Medical University in Szczecin, Poland.'}, {'ForeName': 'Sylwester', 'Initials': 'S', 'LastName': 'Ciećwież', 'Affiliation': 'Department of Gynecology, Endocrinology and Gynecologic Oncology, Pomeranian Medical University in Szczecin, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Brodowska', 'Affiliation': 'Department of Medical Rehabilitation and Clinical Physiotherapy, Pomeranian Medical University in Szczecin, Poland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Szylińska', 'Affiliation': 'Department of Gynecology, Endocrinology and Gynecologic Oncology, Pomeranian Medical University in Szczecin, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Starczewski', 'Affiliation': 'Department of Gynecology, Endocrinology and Gynecologic Oncology, Pomeranian Medical University in Szczecin, Poland.'}, {'ForeName': 'Iwona', 'Initials': 'I', 'LastName': 'Rotter', 'Affiliation': 'Department of Medical Rehabilitation and Clinical Physiotherapy, Pomeranian Medical University in Szczecin, Poland.'}]",BioMed research international,['10.1155/2020/1205281'] 1133,32714989,The Impact of 12-Week Jaques-Dalcroze Eurhythmics Programme on the Dynamic Agility in Single-Dual-Task Conditions in Older Women: A Randomized Controlled Trial.,"Background Progressive degenerative changes in the body of elderly people lead to a decrease in physical and mental fitness. Seniors have a problem with performing tasks that involve both physical and mental health at the same time. The risk of falls increases, the consequences of which in old age may be particularly dangerous. It was decided to investigate the impact of performing exercises involving both physical and mental spheres on the dynamic agility in older women. Methods 73 women (69.9 ± 3.2) were divided into two groups: intervention (IG, n = 34) and control (CG, n = 39). Individuals with IG participated in the Jaques-Dalcroze Eurhythmics exercise programme for 12 weeks, twice a week for 45 minutes each. Dynamic agility was determined by the Timed Up and Go test, which was conducted both in single-task (TUG_ST) and dual-task (TUG_DT) conditions, where the participant was simultaneously counting down from 60 every 3. The percentage difference between the results of both tests (dual-task cost, DTC) was also determined. Both groups had two measurement sessions: one week before the start of the exercise programme and one week after the end of exercise programme. Results After 12 weeks of exercise, IG participants obtained significantly better results in TUG_DT ( p < 0.001) and DTC ( p = 0.003) tests. During this time, CG participants had significantly worse results in TUG_DT ( p < 0.001) and DTC ( p < 0.001) tests. In the TUG_ST test, neither IG nor CG achieved a significant change in the result. In each test, a significant interaction between the group assignment and the measurement session was observed: TUG_ST: F = 11.523, η 2 P = 0.139, p = 0.001; TUG_DT: F = 60.227, η 2 P = 0.458, p < 0.001; DTC: F = 32.382, η 2 P = 0.313, p < 0.001. Conclusion JDE exercises with a frequency of twice a week, for about 12 weeks, have a significant impact on the improvement of the dynamic agility control in women over 65 years of age.",2020,"During this time, CG participants had significantly worse results in TUG_DT ( p < 0.001) and DTC ( p < 0.001) tests.","['older women', 'women over 65 years of age', 'Older Women', '73 women (69.9 ± 3.2']","['Jaques-Dalcroze Eurhythmics exercise programme', '12-Week Jaques-Dalcroze Eurhythmics Programme']","['dynamic agility control', 'Dynamic Agility', 'Dynamic agility', 'physical and mental fitness']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517687', 'cui_str': '3.2'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",73.0,0.0442287,"During this time, CG participants had significantly worse results in TUG_DT ( p < 0.001) and DTC ( p < 0.001) tests.","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Adamczyk', 'Affiliation': 'Department of Dance and Gymnastics, Faculty of Sport Sciences, Poznań University of Physical Education, 61-871 Poznań, Poland.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Celka', 'Affiliation': 'Department of Dance and Gymnastics, Faculty of Sport Sciences, Poznań University of Physical Education, 61-871 Poznań, Poland.'}, {'ForeName': 'Rafał', 'Initials': 'R', 'LastName': 'Stemplewski', 'Affiliation': 'Department of Physical Activity Sciences and Health Promotion, Faculty of Sport Sciences, Poznań University of Physical Education, 61-871 Poznań, Poland.'}, {'ForeName': 'Kinga', 'Initials': 'K', 'LastName': 'Ceynowa', 'Affiliation': 'Faculty of Compositions, Conducting, Theory of Music and Eurhythmics, Academy of Music in Poznań, 61-808 Poznań, Poland.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Kamińska', 'Affiliation': 'Graduate School for Sports Sciences, Poznań University of Physical Education, 61-871 Poznań, Poland.'}, {'ForeName': 'Janusz', 'Initials': 'J', 'LastName': 'Maciaszek', 'Affiliation': 'Department of Physical Activity Sciences and Health Promotion, Faculty of Sport Sciences, Poznań University of Physical Education, 61-871 Poznań, Poland.'}]",BioMed research international,['10.1155/2020/9080697'] 1134,32712322,Postoperative Urinary Retention Rates after Autofill versus Backfill Void Trial following Total Laparoscopic Hysterectomy: A Randomized Controlled Trial.,"STUDY OBJECTIVE To compare the rate of postoperative urinary retention (POUR) after total laparoscopic hysterectomy (TLH) using the autofill vs the backfill void trial. Secondary objectives were to compare the time to discharge from the recovery room, rate of postoperative urinary tract infection (UTI), perceived bladder condition, the effect of bladder function on life, and patient satisfaction. DESIGN Randomized controlled trial. SETTING Single academic medical center. PATIENTS Women who underwent TLH by conventional laparoscopy or robotic-assisted laparoscopy for benign non-urogynecologic indications. INTERVENTIONS After TLH, participants were randomized to have an autofill void trial (group A) or a backfill void trial once they were able to ambulate (group B). Failure rate, time to discharge, and UTI rate were assessed. Participants completed the patient perception of bladder condition and the incontinence impact questionnaire-short form questionnaires. Patient satisfaction was assessed. Multiple regression analysis was performed to determine the predictors of POUR. MEASUREMENTS AND MAIN RESULTS Eighty-two participants completed the study after randomization, 42 in group A and 40 in group B. There were no statistically significant differences in demographic or perioperative outcomes. Seven participants had POUR in group A (16.7%) and 11 in group B (27.5%) (p = .36), respectively. The median time to discharge was 176 minutes for group A (160.5, 255.5) and 218 minutes for group B (180, 265) (p = .01), respectively. There were no statistically significant differences in rate of postoperative UTI (p >.99), patient perception of bladder condition scores (p = .24), incontinence impact questionnaire-short form scores (p = .23), and patient satisfaction scores (p = .26). A stepwise logistic regression analysis did not demonstrate any predictors of POUR. CONCLUSION Backfill void trial once the participant was able to ambulate was not superior to the autofill void trial with respect to the rate of POUR. The autofill void trial resulted in faster same-day discharge.",2021,"There were no statistically significant differences in rate of postoperative UTI (p = 1.00), PPBC scores (p = 0.24), IIQ-7 scores (p = 0.23), and patient satisfaction scores (p = 0.26).","['Single academic medical center', 'Women who underwent', 'for benign non-urogynecologic indications']","['total laparoscopic hysterectomy', 'TLH by conventional laparoscopy or robotic-assisted laparoscopy', 'total laparoscopic hysterectomy (TLH']","['Patient satisfaction', 'IIQ-7 scores', 'patient perception of bladder condition (PPBC) and the incontinence impact questionnaire-short form (IIQ-7) questionnaires', 'Postoperative urinary retention rates', 'PPBC scores', 'time to discharge from the recovery room, rate of postoperative urinary tract infection (UTI), perceived bladder condition, bladder function impact on life, and patient satisfaction', 'rate of postoperative UTI', 'rate of postoperative urinary retention (POUR', 'Failure rate, time to discharge, and UTI rate', 'patient satisfaction scores', 'median time to discharge']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0403709', 'cui_str': 'Postoperative urinary tract infection'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0232840', 'cui_str': 'Bladder function'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",82.0,0.319498,"There were no statistically significant differences in rate of postoperative UTI (p = 1.00), PPBC scores (p = 0.24), IIQ-7 scores (p = 0.23), and patient satisfaction scores (p = 0.26).","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Farag', 'Affiliation': 'Division of Gynecology, Cleveland Clinic Florida, Weston, Florida (all authors).. Electronic address: faragsara@gmail.com.'}, {'ForeName': 'Pamela Frazzini', 'Initials': 'PF', 'LastName': 'Padilla', 'Affiliation': 'Division of Gynecology, Cleveland Clinic Florida, Weston, Florida (all authors).'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Smith', 'Affiliation': 'Division of Gynecology, Cleveland Clinic Florida, Weston, Florida (all authors).'}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Zimberg', 'Affiliation': 'Division of Gynecology, Cleveland Clinic Florida, Weston, Florida (all authors).'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Sprague', 'Affiliation': 'Division of Gynecology, Cleveland Clinic Florida, Weston, Florida (all authors).'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2020.07.013'] 1135,32725642,The minimum clinically important difference on the sleep disorders inventory for people with dementia.,"OBJECTIVES Sleep disturbances in dementia causes distress to people with dementia and their family carers and are associated with care home admission. The Sleep Disorders Inventory (SDI) is a validated questionnaire of sleep disturbances in dementia often used to measure treatment effectiveness, but the minimum clinically important difference (MCID) is unknown. METHODS We triangulated three investigative methods to determine the MCID of the SDI. Using data on SDI from a randomised controlled trial (RCT) with 62 participants in an intervention for sleep disorders in dementia, we (1) calculated distribution-based values where MCID = 0.33 of a SD (SD) (2) an anchor based approach using quality of life (measured using DEMQOL-Proxy) as an anchor. We also employed a Delphi consensus process asking 12 clinicians, sleep researchers and family carers to rate which changes on vignettes were equivalent to a MCID. RESULTS We found that 0.33 SD in the SDI = 4.86. Reduction in SDI total score was not significantly correlated with improvement in DEMQOL-Proxy (Pearson's correlation = -0.01; P = 0.96) score. The Delphi consensus required two rounds to reach a consensus and concluded that changes equivalent to three points on the SDI equated to the MCID. CONCLUSIONS Taking into account both the distribution-based values and the Delphi process we used a whole number at the midpoint and judged the minimum clinically important difference MCID to be equal to four points. We note the clinicians and carers opinions from the Delphi process determined the MCID to be lower at three points.",2020,Reduction in SDI total score was not significantly correlated with improvement in DEMQOL-Proxy (Pearson's correlation = ,"['dementia causes distress to people with dementia and their family carers', 'People with Dementia', '62 participants in an intervention for sleep disorders in dementia, we (1) calculated distribution-based values where MCID\xa0=\xa00.33 of a SD (SD) (2) an anchor based approach using']",[],"['quality of life', 'Sleep Disorders Inventory', 'SDI total score', 'Sleep Disorders Inventory (SDI']","[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4517449', 'cui_str': '0.33'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",[],"[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",62.0,0.0608141,Reduction in SDI total score was not significantly correlated with improvement in DEMQOL-Proxy (Pearson's correlation = ,"[{'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Webster', 'Affiliation': 'Division of Psychiatry, Faculty of Brain Sciences, UCL, Maple House, London, UK.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'Division of Psychiatry, Faculty of Brain Sciences, UCL, Maple House, London, UK.'}, {'ForeName': 'Gill', 'Initials': 'G', 'LastName': 'Livingston', 'Affiliation': 'Division of Psychiatry, Faculty of Brain Sciences, UCL, Maple House, London, UK.'}]",International journal of geriatric psychiatry,['10.1002/gps.5384'] 1136,32721919,Desmopressin acetate decreases blood loss in patients with massive hemorrhage undergoing gastrointestinal surgery.,"BACKGROUND/AIMS Intraoperative blood loss more than 400 mL during gastrointestinal surgery is an independent predictor of mortality. Desmopressin acetate (DDAVP) could reduce perioperative blood loss. Few studies have prompted concerning the effects of DDAVP on gastrointestinal surgery. This study was to investigate whether DDAVP can decrease blood loss in patients with massive hemorrhage undergoing gastrointestinal surgery. MATERIALS AND METHODS A multiple-centers, double-blind clinical trial was conducted, patients who underwent gastrointestinal surgery were recruited from 3 hospitals, randomly assigned to two different groups. Patients in the treatment group received desmopressin 0.3 ug/kg,30 min once a day after surgery, patients in the control group received 50 ml saline for 30 min. The primary outcome was the changes of hemoglobin at 24 hours after the surgery. And the secondary outcomes included coagulation function, urine volume, serum creatinine, and safety. RESULTS There were 59 patients enrolled between 1 June 2015 and 1 June 2017. At 24hr.after surgery, a decrease in hemoglobin in the DDAVP group was significantly lower than that in the NS group (-5.0±6.9 g/L vs. -10.2±9.3g/L, p=0.03). Sonoclot® showed that the platelet function in the DDAVP group was higher than that in NS group at 24 hr. (2.56 ±0.59 vs. 1.91 ±0.72, p<0.05). There was no difference in urine volume and serum creatinine at 24 hr. between two group. CONCLUSION DDAVP could reduce post-operation blood loss in patients with massive hemorrhage undergoing surgery by improving the platelet function. We observed no difference in urine volume and serum creatinine in two groups.",2020,"(2.56 ±0.59 vs. 1.91 ±0.72, p<0.05).","['patients with massive hemorrhage undergoing gastrointestinal surgery', 'patients with massive hemorrhage undergoing surgery', 'patients who underwent gastrointestinal surgery were recruited from 3 hospitals', '59 patients enrolled between 1 June 2015 and 1 June 2017']","['Desmopressin acetate (DDAVP', 'Desmopressin acetate', 'DDAVP', '50 ml saline', 'desmopressin']","['platelet function', 'hemoglobin', 'perioperative blood loss', 'urine volume and serum creatinine', 'coagulation function, urine volume, serum creatinine, and safety', 'changes of hemoglobin', 'blood loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0333279', 'cui_str': 'Massive hemorrhage'}, {'cui': 'C0524722', 'cui_str': 'Gastrointestinal surgery'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0086135', 'cui_str': 'Desmopressin acetate'}, {'cui': 'C0701195', 'cui_str': 'Desmospray'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0011701', 'cui_str': 'desmopressin'}]","[{'cui': 'C0920267', 'cui_str': 'Platelet aggregation test'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",59.0,0.131007,"(2.56 ±0.59 vs. 1.91 ±0.72, p<0.05).","[{'ForeName': 'Li-Chun', 'Initials': 'LC', 'LastName': 'Wang', 'Affiliation': 'Department of Intensive Care Unit, the Sixth Affiliated Hospital of Sun Yat-Sen University，Guangzhou, China.'}, {'ForeName': 'Ying-Fang', 'Initials': 'YF', 'LastName': 'Hu', 'Affiliation': 'Department of Intensive Care Unit, Guangdong Second Provincial General Hospital, Guangzhou, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Intensive Care Unit, the Sixth Affiliated Hospital of Sun Yat-Sen University，Guangzhou, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Xing', 'Affiliation': 'Department of Intensive Care Unit, Guangdong Second Provincial General Hospital, Guangzhou, China.'}, {'ForeName': 'Xin-Feng', 'Initials': 'XF', 'LastName': 'Lin', 'Affiliation': 'Department of Intensive Care Unit, The fist affiliated hospital of Guangzhou university of Chinese medicine, Guangzhou, China.'}, {'ForeName': 'Qiu-Ye', 'Initials': 'QY', 'LastName': 'Kou', 'Affiliation': 'Department of Intensive Care Unit, the Sixth Affiliated Hospital of Sun Yat-Sen University，Guangzhou, China.'}]",The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology,['10.5152/tjg.2020.19021'] 1137,32728734,Using an Adjunctive Treatment to Address Psychological Distress in a National Weight Management Program: Results of an Integrated Pilot Study.,"INTRODUCTION Obesity is highly comorbid with psychological symptoms in veterans, particularly post-traumatic stress disorder (PTSD), depression, and anxiety. Obese veterans with comorbid psychological symptoms often display suboptimal weight loss and poor physical functioning when participating in weight management programs. The MOVE! program aims to increase healthy eating and physical activity to promote weight loss in obese veterans. Adequately addressing psychological barriers is necessary to maximize outcomes in MOVE! for veterans with PTSD, depression, and anxiety. We examined the preliminary outcomes of administering the Healthy Emotions and Improving Health BehavioR Outcomes (HERO) intervention. HERO is adjunctive cognitive-behavioral therapy to MOVE! that addresses PTSD, depression, and anxiety symptom barriers to engagement in physical activity. MATERIALS AND METHODS All recruitment and study procedures were approved by the institutional review board and research and development committees of the Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine in Houston, Texas. Participants gave written informed consent before enrollment. Thirty-four obese veterans with a diagnosis of PTSD, depression, and/or anxiety who were attending MOVE! were assigned to the 8-session HERO group or the usual care (UC) group. Veterans completed assessments of PTSD, depression and anxiety symptoms, physical activity, physical functioning, and weight at baseline, 8 and 16 weeks post treatment. Changes from baseline to 8- and 16-week follow-up on the self-report and clinician-rated measures were assessed, using independent samples t-tests and analyses of covariance. RESULTS At 8 weeks post treatment, participants in the HERO group had significantly higher step counts per day than participants in the UC group. Similarly, at 16 weeks post-treatment, participants in the HERO group continued to experience a significant increase in daily steps taken per day, as well as statistically and clinically significantly lower scores on the depression symptom and PTSD symptom severity. Participants in the HERO group also demonstrated significantly higher scores on the physical functioning inventory than participants in the UC group (44.1 ± 12.1 vs. 35.7 ± 10.7, P = 0.04) at 16 weeks post treatment. CONCLUSIONS Findings of this small trial have important implications pending replication in a more rigorously designed large-scale study. Providing an adjunctive treatment to MOVE! that addresses psychological distress has potential benefits for psychological symptom reduction, engagement in healthy dietary habits, and greater physical activity for individuals who traditionally experience barriers to making positive weight management changes.",2020,"At 8 weeks post treatment, participants in the HERO group had significantly higher step counts per day than participants in the UC group.","['Thirty-four obese veterans with a diagnosis of PTSD, depression, and/or anxiety who were attending MOVE', 'Psychological Distress in a National Weight Management Program', 'All recruitment and study procedures were approved by the institutional review board and research and development committees of the Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine in Houston, Texas', 'Obese veterans with comorbid psychological symptoms often display suboptimal weight loss and poor physical functioning when participating in weight management programs', 'obese veterans', 'veterans with PTSD, depression, and anxiety']","['HERO', '8-session HERO group or the usual care (UC']","['Health BehavioR', 'PTSD, depression and anxiety symptoms, physical activity, physical functioning, and weight', 'physical functioning inventory', 'healthy eating and physical activity', 'daily steps', 'depression symptom and PTSD symptom severity']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}, {'cui': 'C0035170', 'cui_str': 'Research and Development'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}]",,0.0176149,"At 8 weeks post treatment, participants in the HERO group had significantly higher step counts per day than participants in the UC group.","[{'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Evans-Hudnall', 'Affiliation': 'Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety, (MEDVAMC 152), 2002 Holcombe Blvd., Houston, TX 77030.'}, {'ForeName': 'Mary O', 'Initials': 'MO', 'LastName': 'Odafe', 'Affiliation': 'Department of Clinical Psychology, University of Houston, Heyne building # 126, Houston, TX 77204.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Johnson', 'Affiliation': 'William S. Middleton Veterans Affairs Hospital, 2500 Overlook Terrace, Madison, WI 53705.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Armenti', 'Affiliation': 'Department of Clinical Psychology, University of Houston, Heyne building # 126, Houston, TX 77204.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': ""O'Neil"", 'Affiliation': 'Department of Psychiatry and Behavioral Medicine, One Baylor Plaza, Baylor College of Medicine, Houston, TX 77030.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Lawson', 'Affiliation': 'Department of Counseling Psychology, University of North Texas, 1155 Union Circle #311280, Denton, Texas 76203-5017.'}, {'ForeName': 'Lisa H', 'Initials': 'LH', 'LastName': 'Trahan', 'Affiliation': 'Trahan Counseling, 631 Mill Street, Suite 101 San Marcos, Texas 78666.'}, {'ForeName': 'Fenan S', 'Initials': 'FS', 'LastName': 'Rassu', 'Affiliation': 'Department of Psychiatry and Behavioral Medicine, One Baylor Plaza, Baylor College of Medicine, Houston, TX 77030.'}]",Military medicine,['10.1093/milmed/usaa145'] 1138,32728763,Anthropometric Aspects in the Breast Augmentation.,"BACKGROUND Studies have demonstrated the importance of anthropometric measurements of the breasts, based on linear measurements for the selection of the volume of breast implants, their positioning, and surgical planning. OBJECTIVES The objective of this study is to evaluate the main changes in anthropometric measurements in breast augmentation. METHODS A prospective, randomized clinical study with 74 female candidates for breast augmentation. All the individuals were split into five groups, according to the implant volume. The implants used were of different textures, from three different brands (LifeSil, Politech, and Silimed). The following measures were taken: distance from the nipple to the inframammary fold (N-IMF), inter-nipple-areolar complex distance (N-N), distance from the Sternal notch to the Nipple (SN-N), areola diameter, and breast projection. RESULTS The most significant breast anthropometric alteration after mammoplasty was the N-IMF distance; that is, an expansion of the lower pole of the breast, followed by an increase in the areolar diameter. Mostly of measurements showed stability between 3rd and 6th months after the surgery. The projection was the most interesting measure due to presenting two patterns of behavior according to the analysis criteria performed. When comparing the implant projection and the final breast projection, it was observed that the implant profile represented a 27% increase in the final breast projection. CONCLUSIONS This study provides an essential comparative analysis between anthropometric changes in breast augmentations and serves as a predictive tool in the preoperative evaluation of the patient during surgical planning. LEVEL OF EVIDENCE IV This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .",2020,"When comparing the implant projection and the final breast projection, it was observed that the implant profile represented a 27% increase in the final breast projection. ",['74 female candidates for breast augmentation'],['IV'],"['nipple to the inframammary fold (N-IMF), inter-nipple-areolar complex distance (N-N), distance from the Sternal notch to the Nipple (SN-N), areola diameter, and breast projection']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0191925', 'cui_str': 'Augmentation mammoplasty'}]",[],"[{'cui': 'C0028109', 'cui_str': 'Nipple structure'}, {'cui': 'C0442099', 'cui_str': 'Inframammary'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205316', 'cui_str': 'Notched'}, {'cui': 'C0222608', 'cui_str': 'Areola structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}]",74.0,0.034736,"When comparing the implant projection and the final breast projection, it was observed that the implant profile represented a 27% increase in the final breast projection. ","[{'ForeName': 'Luiz', 'Initials': 'L', 'LastName': 'Charles-de-Sá', 'Affiliation': 'Department of Plastic, Reconstructive and Aesthetic Surgery, Training and Research, State University of Rio de Janeiro- UERJ-RJ, Av. Joana Angélica, 124/602, Ipanema, Rio de Janeiro-Rj-Cep, 22420-030, Brazil. clinicaperforma@uol.com.br.'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'de Aguiar Valladão', 'Affiliation': 'Department of Plastic, Reconstructive and Aesthetic Surgery, Training and Research, State University of Rio de Janeiro- UERJ-RJ, Av. Joana Angélica, 124/602, Ipanema, Rio de Janeiro-Rj-Cep, 22420-030, Brazil.'}, {'ForeName': 'Diogo Maciel Lobão', 'Initials': 'DML', 'LastName': 'Vieira', 'Affiliation': 'Department of Plastic, Reconstructive and Aesthetic Surgery, Training and Research, State University of Rio de Janeiro- UERJ-RJ, Av. Joana Angélica, 124/602, Ipanema, Rio de Janeiro-Rj-Cep, 22420-030, Brazil.'}, {'ForeName': 'José Horácio', 'Initials': 'JH', 'LastName': 'Aboudib', 'Affiliation': 'Department of Plastic, Reconstructive and Aesthetic Surgery, Training and Research, State University of Rio de Janeiro- UERJ-RJ, Av. Joana Angélica, 124/602, Ipanema, Rio de Janeiro-Rj-Cep, 22420-030, Brazil.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01853-5'] 1139,32744599,Group-Based vs Individual Pelvic Floor Muscle Training to Treat Urinary Incontinence in Older Women: A Randomized Clinical Trial.,"Importance Urinary incontinence is one of the most prevalent health concerns experienced by older women (aged ≥60 years). Individual pelvic floor muscle training (PFMT) is the recommended first-line treatment for stress or mixed urinary incontinence in women, but human and financial resources limit its delivery. Whether group-based PFMT performs as well as individual PFMT in this population remains unclear. Objective To assess the efficacy of group-based PFMT relative to individual PFMT for urinary incontinence in older women. Design, Setting, and Participants The Group Rehabilitation or Individual Physiotherapy (GROUP) study is a single-blind, randomized, noninferiority trial conducted in 2 Canadian research centers, from July 1, 2012, to June 2, 2018. A total of 362 community-dwelling women aged 60 years or older with symptoms of stress or mixed urinary incontinence were enrolled. Interventions After an individual session conducted to learn how to contract pelvic floor muscles, participants completed 12-week PFMT as part of a group of 8 women (n = 178) or in individual sessions (n = 184). Main Outcomes and Measures The primary outcome measure was the percentage reduction in urinary incontinence episodes at 1 year, as reported in a 7-day bladder diary and relative to pretreatment baseline. Secondary outcomes included lower urinary tract-related signs, symptoms, and quality of life immediately following treatment and at 1 year. Per-protocol analysis was used. Results Among 362 women who were randomized (mean [SD] age, 67.9 [5.8] years), 319 women (88%) completed the 1-year follow-up and were included in the per-protocol analysis. Median percentage reduction in urinary incontinence episodes was 70% (95% CI, 44%-89%) in individual PFMT compared with 74% (95% CI, 46%-86%) in group-based PFMT. The upper boundary of the 95% CI for the difference in the percentage reduction in urinary incontinence episodes at 1 year was lower than the prespecified margin for noninferiority of 10% (difference, 4%; 95% CI, -10% to 7%; P = .58), confirming noninferiority. Individual PFMT and group-based PFMT had similar effectiveness for all secondary outcomes at 1 year. Adverse events were minor and uncommon. Conclusions and Relevance Results of the GROUP study suggest that group-based PFMT is not inferior to the recommended individual PFMT for the treatment of stress and mixed urinary incontinence in older women. Widespread use in clinical practice may help increase continence-care affordability and treatment availability. Trial Registration ClinicalTrials.gov Identifier: NCT02039830.",2020,"Median percentage reduction in urinary incontinence episodes was 70% (95% CI, 44%-89%) in individual PFMT compared with 74% (95% CI, 46%-86%) in group-based PFMT.","['older women', 'Older Women', '362 women who were randomized (mean [SD] age, 67.9 [5.8] years), 319 women (88%) completed the 1-year follow-up and were included in the per-protocol analysis', 'older women (aged ≥60 years', '2 Canadian research centers, from July 1, 2012, to June 2, 2018', '362 community-dwelling women aged 60 years or older with symptoms of stress or mixed urinary incontinence were enrolled']","['Individual pelvic floor muscle training (PFMT', 'Individual Pelvic Floor Muscle Training', 'Group Rehabilitation or Individual Physiotherapy (GROUP', 'Individual PFMT and group-based PFMT', 'group-based PFMT relative to individual PFMT']","['percentage reduction in urinary incontinence episodes at 1 year, as reported in a 7-day bladder diary and relative to pretreatment baseline', 'Adverse events', 'urinary incontinence episodes', 'lower urinary tract-related signs, symptoms, and quality of life']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0869256', 'cui_str': 'Mixed urinary incontinence'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0729866', 'cui_str': 'Lower urinary tract structure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",362.0,0.140746,"Median percentage reduction in urinary incontinence episodes was 70% (95% CI, 44%-89%) in individual PFMT compared with 74% (95% CI, 46%-86%) in group-based PFMT.","[{'ForeName': 'Chantale', 'Initials': 'C', 'LastName': 'Dumoulin', 'Affiliation': 'School of Rehabilitation, Faculty of Medicine, Université de Montréal and Research Center of the Institut Universitaire de Gériatrie de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Morin', 'Affiliation': ""School of Rehabilitation, Faculty of Medicine and Health Sciences, Université de Sherbrooke, Research Center of the Centre Hospitalier de l'Université de Sherbrooke, Sherbrooke, Québec, Canada.""}, {'ForeName': 'Coraline', 'Initials': 'C', 'LastName': 'Danieli', 'Affiliation': 'Research Institute of the McGill University Health Center, Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Québec, Canada.'}, {'ForeName': 'Licia', 'Initials': 'L', 'LastName': 'Cacciari', 'Affiliation': 'School of Rehabilitation, Faculty of Medicine, Université de Montréal and Research Center of the Institut Universitaire de Gériatrie de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Mayrand', 'Affiliation': ""Department of Obstetrics and Gynecology and Social and Preventive Medicine, Université de Montréal, Research Center of the Centre Hospitalier de l'Université de Montréal, Montréal, Québec, Canada.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Tousignant', 'Affiliation': ""School of Rehabilitation, Faculty of Medicine and Health Sciences, Université de Sherbrooke, Research Center of the Centre Hospitalier de l'Université de Sherbrooke, Sherbrooke, Québec, Canada.""}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Abrahamowicz', 'Affiliation': 'Department of Epidemiology, Biostatistics, and Occupational Health, McGill University and Research Institute of the McGill University Health Center, Montreal, Québec, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA internal medicine,['10.1001/jamainternmed.2020.2993'] 1140,32739319,Effect of baseline sarcopenia on adjuvant treatment for D2 dissected gastric cancer: Analysis of the ARTIST phase III trial.,"BACKGROUND AND PURPOSE This study evaluated the clinical significance of preoperative sarcopenia according to adjuvant concurrent chemo-radiotherapy (XP-RT) or chemotherapy alone (XP) in the D2 dissected gastric cancer patient cohort of the ARTIST trial. MATERIALS AND METHODS Skeletal muscles at the L3 vertebra level from preoperative computed tomography images among the ARTIST trial participants were measured using validated in-house software. Skeletal muscle index (SMI) was defined as the measured skeletal muscle area divided by the square of the height, and sarcopenia was defined according to the Korean-specific cutoff, i.e. L3 SMI ≤ 49 cm 2 /m 2 for men and ≤31 cm 2 /m 2 for women. RESULTS Among the 440 patients in whom we were able to evaluate L3 SMI, 75 (17.0%) met the definition for preoperative sarcopenia. No differences in treatment-related toxicities or treatment compliance were observed according to the presence of preoperative sarcopenia in either treatment arm. In the subgroup of patients without preoperative sarcopenia, recurrence was significantly lower in the XP-RT arm than that in the XP arm (p = 0.02). Recurrence-free survival (RFS) was also significantly higher in the XP-RT arm (p = 0.02, hazard ratio 0.633, 95% confidence interval 0.433-0.926) in this subgroup. In the multivariate analysis, and after adjusting for significant prognostic factors, the superior outcome of XP-RT arm regarding RFS was maintained in the subgroup of the patients without preoperative sarcopenia. CONCLUSIONS Superior clinical outcomes of adjuvant XP-RT over XP were only observed in patients without preoperative sarcopenia.",2020,No differences in treatment-related toxicities or treatment compliance were observed according to the presence of preoperative sarcopenia in either treatment arm.,"['Skeletal muscles at the L3 vertebra level from preoperative computed tomography images among the ARTIST trial participants were measured using validated in-house software', '440 patients in whom we were able to evaluate L3 SMI, 75 (17.0%) met the definition for preoperative sarcopenia', 'D2 dissected gastric cancer', 'D2 dissected gastric cancer patient cohort of the ARTIST trial']","['adjuvant concurrent chemo-radiotherapy (XP-RT) or chemotherapy alone (XP', 'baseline sarcopenia']","['Skeletal muscle index (SMI', 'preoperative sarcopenia, recurrence', 'Recurrence-free survival (RFS']","[{'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0223522', 'cui_str': 'Bone structure of L3'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0402043', 'cui_str': 'Artist'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0205239', 'cui_str': 'Dissecting'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}]","[{'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}]",440.0,0.0407846,No differences in treatment-related toxicities or treatment compliance were observed according to the presence of preoperative sarcopenia in either treatment arm.,"[{'ForeName': 'Jeong Il', 'Initials': 'JI', 'LastName': 'Yu', 'Affiliation': 'Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. Electronic address: jeongil.yu@samsung.com.'}, {'ForeName': 'Changhoon', 'Initials': 'C', 'LastName': 'Choi', 'Affiliation': 'Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jeeyun', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Won Ki', 'Initials': 'WK', 'LastName': 'Kang', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Se Hoon', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seung Tae', 'Initials': 'ST', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jung Yong', 'Initials': 'JY', 'LastName': 'Hong', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sung', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Tae Sung', 'Initials': 'TS', 'LastName': 'Sohn', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jun Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ji Yeong', 'Initials': 'JY', 'LastName': 'An', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Min Gew', 'Initials': 'MG', 'LastName': 'Choi', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jae Moon', 'Initials': 'JM', 'LastName': 'Bae', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kyoung-Mee', 'Initials': 'KM', 'LastName': 'Kim', 'Affiliation': 'Department of Pathology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Heewon', 'Initials': 'H', 'LastName': 'Han', 'Affiliation': 'Statistics and Data Center, Research Institute for Future Medicine, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Kyunga', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Statistics and Data Center, Research Institute for Future Medicine, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Heerim', 'Initials': 'H', 'LastName': 'Nam', 'Affiliation': 'Department of Radiation Oncology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Do Hoon', 'Initials': 'DH', 'LastName': 'Lim', 'Affiliation': 'Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. Electronic address: dh8.lim@samsung.com.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.07.043'] 1141,32739320,Reduced Dose Posterior to Prostate Correlates With Increased PSA Progression in Voxel-Based Analysis of 3 Randomized Phase 3 Trials.,"PURPOSE Reducing margins during treatment planning to decrease dose to healthy organs surrounding the prostate can risk inadequate treatment of subclinical disease. This study aimed to investigate whether lack of dose to subclinical disease is associated with increased disease progression by using high-quality prostate radiation therapy clinical trial data to identify anatomically localized regions where dose variation is associated with prostate-specific antigen progression (PSAP). METHODS AND MATERIALS Planned dose distributions for 683 patients of the Trans-Tasman Radiation Oncology Group 03.04 Randomized Androgen Deprivation and Radiotherapy (RADAR) trial were deformably registered onto a single exemplar computed tomography data set. These were divided into high-risk and intermediate-risk subgroups for analysis. Three independent voxel-based statistical tests, using permutation testing, Cox regression modeling, and least absolute shrinkage selection operator feature selection, were applied to identify regions where dose variation was associated with PSAP. Results from the intermediate-risk RADAR subgroup were externally validated by registering dose distributions from the RT01 (n = 388) and Conventional or Hypofractionated High Dose Intensity Modulated Radiotherapy for Prostate Cancer Trial (CHHiP) (n = 253) trials onto the same exemplar and repeating the tests on each of these data sets. RESULTS Voxel-based Cox regression revealed regions where reduced dose was correlated with increased prostate-specific androgen progression. Reduced dose in regions associated with coverage at the posterior prostate, in the immediate periphery of the posterior prostate, and in regions corresponding to the posterior oblique beams or posterior lateral beam boundary, was associated with increased PSAP for RADAR and RT01 patients, but not for CHHiP patients. Reduced dose to the seminal vesicle region was also associated with increased PSAP for RADAR intermediate-risk patients. CONCLUSIONS Ensuring adequate dose coverage at the posterior prostate and immediately surrounding posterior region (including the seminal vesicles), where aggressive cancer spread may be occurring, may improve tumor control. It is recommended that particular care be taken when defining margins at the prostate posterior, acknowledging the trade-off between quality of life due to rectal dose and the preferences of clinicians and patients.",2020,"Reduced dose to the seminal vesicles (SV) region was also associated with increased PSAP for 'Trial-A' intermediate-risk patients. ","[""683 patients of the 'Trial-A's name' were deformably registered onto a single exemplar computed tomography (CT) dataset""]",[],['PSA progression'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}]",[],"[{'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}]",,0.0428037,"Reduced dose to the seminal vesicles (SV) region was also associated with increased PSAP for 'Trial-A' intermediate-risk patients. ","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Marcello', 'Affiliation': 'Department of Physics, University of Western Australia, Perth, Western Australia, Australia; Department of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia. Electronic address: 20739859@student.uwa.edu.au.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Denham', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Kennedy', 'Affiliation': 'Department of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Haworth', 'Affiliation': 'School of Physics, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Steigler', 'Affiliation': 'Prostate Cancer Trials Group, School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Greer', 'Affiliation': 'School of Mathematical and Physical Sciences, University of Newcastle, Newcastle, New South Wales, Australia; Department of Radiation Oncology, Calvary Mater Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Lois C', 'Initials': 'LC', 'LastName': 'Holloway', 'Affiliation': 'Department of Medical Physics, Liverpool Cancer Centre, Sydney, New South Wales, Australia; South Western Sydney Clinical School, University of New South Wales, Sydney, New South Wales, Australia; Centre for Medical Radiation Physics, University of Wollongong, Wollongong, New South Wales, Australia.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Dowling', 'Affiliation': 'School of Mathematical and Physical Sciences, University of Newcastle, Newcastle, New South Wales, Australia; CSIRO, Brisbane, Queensland, Australia.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Jameson', 'Affiliation': 'Department of Medical Physics, Liverpool Cancer Centre, Sydney, New South Wales, Australia; South Western Sydney Clinical School, University of New South Wales, Sydney, New South Wales, Australia; Centre for Medical Radiation Physics, University of Wollongong, Wollongong, New South Wales, Australia; Cancer Research Team, Ingham Institute for Applied Medical Research, Sydney, New South Wales, Australia.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Roach', 'Affiliation': 'Department of Medical Physics, Liverpool Cancer Centre, Sydney, New South Wales, Australia; South Western Sydney Clinical School, University of New South Wales, Sydney, New South Wales, Australia; Cancer Research Team, Ingham Institute for Applied Medical Research, Sydney, New South Wales, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Joseph', 'Affiliation': 'School of Surgery, University of Western Australia, Perth, Western Australia, Australia; 5D Clinics, Claremont, Perth, Western Australia, Australia; GenesisCare WA, Perth, Western Australia, Australia.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Gulliford', 'Affiliation': 'Radiotherapy Department, University College London Hospitals NHS Foundation Trust, London, United Kingdom; Department of Medical Physics and Biomedical Engineering, University College London, London, United Kingdom.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Dearnaley', 'Affiliation': 'Academic UroOncology Unit, The Institute of Cancer Research and the Royal Marsden NHS Trust, London, United Kingdom.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Sydes', 'Affiliation': 'MRC Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Ebert', 'Affiliation': 'Department of Physics, University of Western Australia, Perth, Western Australia, Australia; Department of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia; 5D Clinics, Claremont, Perth, Western Australia, Australia.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.07.030'] 1142,32747975,TAS-303 effects on urethral sphincter function in women with stress urinary incontinence: phase I study.,"INTRODUCTION AND HYPOTHESIS TAS-303, which selectively inhibits noradrenaline reuptake, was developed for treating stress urinary incontinence (SUI). The proximal urethra mainly comprises smooth muscle fibers in which α1 adrenergic receptors are abundant. This study was conducted to evaluate the effect of TAS-303 on urethral function and its safety profile in female patients with SUI. METHODS In total, 16 women (age, 20-64 years) with SUI and > 5.0 g of leakage in the 1-h pad test at screening were randomized and administered the assigned treatment in a double-blind manner. The primary end point was change in the maximal urethral closure pressure (MUCP) at 6 h post-dose. The secondary end point was change in the urethral closure pressure of the entire urethra and each urethral region (proximal, middle, and distal) at 6 h post-dose. The results were analyzed using a t-test. RESULTS The mean change ± standard deviation in MUCP at 6 h post-dose was 3.473 ± 12.154 cmH 2 O for TAS-303 and 2.615 ± 9.794 cmH 2 O for placebo (between-group difference: 0.858 cmH 2 O, P = 0.8047). The mean changes ± standard deviation in urethral closure pressure of the proximal urethra at 6 h after the administration of TAS-303 18 mg and placebo were 3.863 ± 10.941 and 1.634 ± 12.093, respectively (between-group difference: 2.229 cmH 2 O, P = 0.5976). CONCLUSIONS No significant difference in MUCP and urethral closure pressure was found between TAS-303 and placebo. However, the change in the proximal urethral closure pressure with TAS-303 was larger than that with placebo. This suggests that TAS-303 has pharmacological effects on urethral sphincteric function.",2021,No significant difference in MUCP and urethral closure pressure was found between TAS-303 and placebo.,"['women with stress urinary incontinence', 'female patients with SUI', '16 women (age, 20-64 years) with SUI and\u2009>\u20095.0\xa0g of leakage in the 1-h pad test at screening']","['placebo', 'TAS-303 and placebo', 'TAS-303']","['mean changes ± standard deviation in urethral closure pressure of the proximal urethra', 'maximal urethral closure pressure (MUCP', 'MUCP and urethral closure pressure', 'urethral sphincteric function', 'proximal urethral closure pressure with TAS-303', 'urethral sphincter function', 'urethral closure pressure of the entire urethra and each urethral region (proximal, middle, and distal', 'urethral function', 'mean change ± standard deviation in MUCP']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0559483', 'cui_str': 'Pentalogy of Cantrell'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0041967', 'cui_str': 'Urethral'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0559483', 'cui_str': 'Pentalogy of Cantrell'}, {'cui': 'C0429819', 'cui_str': 'Urethral sphincter function'}, {'cui': 'C1281574', 'cui_str': 'Entire urethra'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0422815', 'cui_str': 'Urethral function'}]",16.0,0.148755,No significant difference in MUCP and urethral closure pressure was found between TAS-303 and placebo.,"[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Yono', 'Affiliation': 'Department of Urology, Nishi Kumamoto Hospital, Souseikai, Kumamoto, Japan. m-yonou@nishikuma.com.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Irie', 'Affiliation': 'Department of Clinical Pharmacology, Nishi Kumamoto Hospital, Souseikai, Kumamoto, Japan.'}, {'ForeName': 'Momokazu', 'Initials': 'M', 'LastName': 'Gotoh', 'Affiliation': 'Department of Urology, Nagoya University Graduate School of Medicine, Aichi, Japan.'}]",International urogynecology journal,['10.1007/s00192-020-04470-7'] 1143,32747995,Improved metabolic function and cognitive performance in middle-aged adults following a single dose of wild blueberry.,"PURPOSE Research has demonstrated cognitive benefits following acute polyphenol-rich berry consumption in children and young adults. Berry intake also has been associated with metabolic benefits. No study has yet examined cognitive performance in middle-aged adults. We investigated the relationships among cognitive and metabolic outcomes in middle-aged adults following wild blueberry (WBB) consumption. METHODS Thirty-five individuals aged 40-65 years participated in a randomized, double blind, cross-over study. Participants consumed a breakfast meal and 1-cup equivalent WBB drink or matched placebo beverage on two occasions. Participants completed cognitive tasks and had blood drawn before and at regular intervals for 8 h after each meal/treatment. Changes in episodic memory and executive function (EF) were assessed alongside plasma levels of glucose, insulin, and triglyceride. RESULTS Analysis of the memory-related Auditory Verbal Learning Task (AVLT) word recognition measure revealed a decrease in performance over the test day after placebo intake, whereas performance after WBB was maintained. For the AVLT word rejection measure, participants identified more foils following WBB in comparison to placebo. Benefits were also observed for EF on the Go/No-Go task with fewer errors following WBB intake on cognitively demanding invalid No-Go trials in comparison to placebo. Furthermore, in comparison to placebo, response times were faster for the Go/No-Go task, specifically at 4 h and 8 h following WBB treatment. We also observed reduced post-meal glucose and insulin, but not triglyceride, concentrations in comparison to placebo over the first 2 h following ingestion. Though the addition of Age, BMI, glucose and insulin as covariates to the analysis reduced the significant effect of beverage for AVLT word rejection, metabolic outcomes did not interact with treatment to predict cognitive performance with the exception of one isolated trend. CONCLUSIONS This study indicated acute cognitive benefits of WBB intake in cognitively healthy middle-aged individuals, particularly in the context of demanding tasks and cognitive fatigue. WBB improved glucose and insulin responses to a meal. Further research is required to elucidate the underlying mechanism by which WBB improves cognitive function.",2021,Benefits were also observed for EF on the Go/No-Go task with fewer errors following WBB intake on cognitively demanding invalid No-Go trials in comparison to placebo.,"['middle-aged adults following wild blueberry (WBB) consumption', 'middle-aged adults', 'Thirty-five individuals aged 40-65\xa0years', 'cognitively healthy middle-aged individuals', 'children and young adults']","['breakfast meal and 1-cup equivalent WBB drink or matched placebo', 'acute polyphenol-rich berry consumption', 'placebo']","['cognitive performance', 'metabolic function and cognitive performance', 'cognitive tasks and had blood drawn', 'memory-related Auditory Verbal Learning Task (AVLT) word recognition measure', 'episodic memory and executive function (EF', 'plasma levels of glucose, insulin, and triglyceride', 'cognitive function', 'WBB improved glucose and insulin responses']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0950037', 'cui_str': 'Blueberries'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0950037', 'cui_str': 'Blueberries'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0005135', 'cui_str': 'Berry'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0950037', 'cui_str': 'Blueberries'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",35.0,0.240134,Benefits were also observed for EF on the Go/No-Go task with fewer errors following WBB intake on cognitively demanding invalid No-Go trials in comparison to placebo.,"[{'ForeName': 'Adrian R', 'Initials': 'AR', 'LastName': 'Whyte', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Earley Gate, Whiteknights, Reading, RG6 6AL, UK.'}, {'ForeName': 'Sajida', 'Initials': 'S', 'LastName': 'Rahman', 'Affiliation': 'Centre for Nutrition Research, Department of Food Science and Nutrition, Illinois Institute of Technology, Chicago, IL, USA.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Bell', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Earley Gate, Whiteknights, Reading, RG6 6AL, UK.'}, {'ForeName': 'Indika', 'Initials': 'I', 'LastName': 'Edirisinghe', 'Affiliation': 'Centre for Nutrition Research, Department of Food Science and Nutrition, Illinois Institute of Technology, Chicago, IL, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Krikorian', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati Academic Health Centre, Cincinnati, OH, USA.'}, {'ForeName': 'Claire M', 'Initials': 'CM', 'LastName': 'Williams', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Earley Gate, Whiteknights, Reading, RG6 6AL, UK. claire.williams@reading.ac.uk.'}, {'ForeName': 'Britt', 'Initials': 'B', 'LastName': 'Burton-Freeman', 'Affiliation': 'Centre for Nutrition Research, Department of Food Science and Nutrition, Illinois Institute of Technology, Chicago, IL, USA.'}]",European journal of nutrition,['10.1007/s00394-020-02336-8'] 1144,32749625,Web-Based Cognitive Training to Improve Working Memory in Persons with Co-Occurring HIV Infection and Cocaine Use Disorder: Outcomes from a Randomized Controlled Trial.,"Neurocognitive impairment (NCI) remains a persistent complication of HIV disease that nearly half of persons with HIV experience, and rates are even higher in persons who use substances such as cocaine. Cognitive training is a promising intervention for HIV-associated NCI. In this randomized controlled trial, we examined the feasibility and effectiveness of a web-based cognitive training program to improve working memory in a sample of 58 persons with HIV and cocaine use disorder. Participants were randomly assigned to either the experimental working memory training arm or the attention control training arm and completed up to 48 daily sessions over 10 weeks. Overall, treatment completion (74%) and retention rates (97%) were high, and participant feedback indicated the intervention was acceptable. Our results show that the intervention successfully reduced working memory deficits in the experimental arm relative to the control arm. Our findings support both the feasibility and effectiveness of cognitive training in this population.",2021,Participants were randomly assigned to either the experimental working memory training arm or the attention control training arm and completed up to 48 daily sessions over 10 weeks.,"['Persons with Co-Occurring HIV Infection and Cocaine Use Disorder', '58 persons with HIV and cocaine use disorder']","['Cognitive training', 'cognitive training', 'Web-Based Cognitive Training', 'web-based cognitive training program', 'experimental working memory training arm or the attention control training']","['working memory deficits', 'retention rates', 'working memory']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",58.0,0.0536141,Participants were randomly assigned to either the experimental working memory training arm or the attention control training arm and completed up to 48 daily sessions over 10 weeks.,"[{'ForeName': 'Sheri L', 'Initials': 'SL', 'LastName': 'Towe', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Duke University School of Medicine, Box 102848, Durham, NC, 27710, USA. sheri.towe@duke.edu.'}, {'ForeName': 'Jeremiah T', 'Initials': 'JT', 'LastName': 'Hartsock', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Duke University School of Medicine, Box 102848, Durham, NC, 27710, USA.'}, {'ForeName': 'Yunan', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Duke University School of Medicine, Box 102848, Durham, NC, 27710, USA.'}, {'ForeName': 'Christina S', 'Initials': 'CS', 'LastName': 'Meade', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Duke University School of Medicine, Box 102848, Durham, NC, 27710, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02993-0'] 1145,32745598,Changes in Intrinsic Brain Connectivity in Family-Focused Therapy Versus Standard Psychoeducation Among Youths at High Risk for Bipolar Disorder.,"OBJECTIVE We compared intrinsic network connectivity in symptomatic youths at high risk (HR) for bipolar disorder (BD) and healthy comparison (HC) youths. In HR youths, we also investigated treatment-related changes in intrinsic connectivity after family-focused therapy for high-risk youths (FFT-HR) vs standardized family psychoeducation. METHOD HR youths (N = 34; age 9-17 years; mean 14 years, 56% girls and 44% boys) with depressive and/or hypomanic symptoms and at least 1 first- or second-degree relative with BD I or II were randomly assigned to 4 months of FFT-HR (12 sessions of psychoeducation, communication, and problem-solving skills training) or enhanced care (EC; 3 family and 3 individual psychoeducation sessions). Before and after 4 months of treatment, participants underwent resting state functional magnetic resonance imaging (rs-fMRI). A whole-brain independent component analysis compared rs-fMRI networks in HR youths and 30 age-matched HC youths at a pretreatment baseline. Then we identified pretreatment to posttreatment (4-month) changes in network connectivity in HR youths receiving FFT-HR (n = 16) or EC (n = 18) and correlated these changes with depression improvement. RESULTS At baseline, HR youths had greater connectivity between the ventrolateral prefrontal cortex (VLPFC) and the anterior default mode network (aDMN) than did HCs (p = .004). Over 4 months of treatment, FFT-HR-assigned HR youths had increased VLPFC-aDMN connectivity from pre- to posttreatment (p = .003), whereas HR youths in EC showed no significant change over time (p = .11) (treatment by time interaction, t 31  = 3.33, 95% CI = 0.27-1.14, p = .002]. Reduction in depression severity over 4 months inversely correlated with enhanced anterior DMN (r = -0.71) connectivity in the FFT-HR but not in the EC (r = -0.07) group (z = -2.17, p = .015). CONCLUSION Compared to standard psychoeducation, FFT-HR is associated with stronger connectivity between the VLPFC and aDMN, suggesting possible enhancements of self-awareness, illness awareness, and emotion regulation. CLINICAL TRIAL REGISTRATION INFORMATION Early Intervention for Youth at Risk for Bipolar Disorder; https://clinicaltrials.gov/; NCT01483391.",2021,"Compared to standard psychoeducation, FFT-HR is associated with stronger connectivity between the VLPFC and aDMN, suggesting possible enhancements of self- and illness awareness and emotion regulation.","['Youth at High Risk for Bipolar Disorder', 'Family', 'HR youth (N=34; age 9-17 years; mean 14 years, 56% girls) with depressive and/or hypomanic symptoms and at least one first- or second-degree relative with BD I or II', 'symptomatic youth at high risk (HR) for bipolar disorder (BD) and healthy comparison (HC) youth, and, in HR youth']","['FFT-HR (n=16) or EC', 'Focused Therapy Versus Standard Psychoeducation', 'FFT-HR (12 sessions of psychoeducation, communication, and problem-solving skills training) or Enhanced Care (EC; 3 family and 3 individual psychoeducation sessions', 'resting state functional magnetic resonance imaging (rs-fMRI']","['VLPFC-aDMN connectivity', 'depression severity', 'depression improvement']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0443298', 'cui_str': 'Second degree'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0256181,"Compared to standard psychoeducation, FFT-HR is associated with stronger connectivity between the VLPFC and aDMN, suggesting possible enhancements of self- and illness awareness and emotion regulation.","[{'ForeName': 'Manpreet K', 'Initials': 'MK', 'LastName': 'Singh', 'Affiliation': 'Stanford University School of Medicine, California. Electronic address: mksingh@stanford.edu.'}, {'ForeName': 'Akua F', 'Initials': 'AF', 'LastName': 'Nimarko', 'Affiliation': 'Stanford University School of Medicine, California.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Garrett', 'Affiliation': 'University of Texas, Health Science Center at San Antonio.'}, {'ForeName': 'Aaron J', 'Initials': 'AJ', 'LastName': 'Gorelik', 'Affiliation': 'University of California, Davis.'}, {'ForeName': 'Donna J', 'Initials': 'DJ', 'LastName': 'Roybal', 'Affiliation': 'University of Texas, Health Science Center at San Antonio.'}, {'ForeName': 'Patricia D', 'Initials': 'PD', 'LastName': 'Walshaw', 'Affiliation': 'University of California, Los Angeles School of Medicine.'}, {'ForeName': 'Kiki D', 'Initials': 'KD', 'LastName': 'Chang', 'Affiliation': 'private practice, Menlo Park, California.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Miklowitz', 'Affiliation': 'University of California, Los Angeles School of Medicine.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2020.07.892'] 1146,32745667,Relationships between rectal and perirectal doses and rectal bleeding or tenesmus in pooled voxel-based analysis of 3 randomised phase III trials.,"BACKGROUND AND PURPOSE This study aimed to identify anatomically-localised regions where planned radiotherapy dose is associated with gastrointestinal toxicities in healthy tissues throughout the pelvic anatomy. MATERIALS AND METHODS Planned dose distributions for up to 657 patients of the Trans Tasman Radiation Oncology Group 03.04 RADAR trial were deformably registered onto a single exemplar computed tomography dataset. Voxel-based multiple comparison permutation dose difference testing, Cox regression modelling and LASSO feature selection were used to identify regions where dose-increase was associated with grade ≥2 rectal bleeding (RB) or tenesmus, according to the LENT/SOMA scale. This was externally validated by registering dose distributions from the RT01 (n = 388) and CHHiP (n = 241) trials onto the same exemplar and repeating the tests on each of these data sets, and on all three datasets combined. RESULTS Voxel-based Cox regression and permutation dose difference testing revealed regions where increased dose was correlated with gastrointestinal toxicity. Grade ≥2 RB was associated with posteriorly extended lateral beams that manifested high doses (>55 Gy) in a small rectal volume adjacent to the clinical target volume. A correlation was found between grade ≥2 tenesmus and increased low-intermediate dose (∼25 Gy) at the posterior beam region, including the posterior rectum and perirectal fat space (PRFS). CONCLUSIONS The serial response of the rectum with respect to RB has been demonstrated in patients with posteriorly extended lateral beams. Similarly, the parallel response of the PRFS with respect to tenesmus has been demonstrated in patients treated with the posterior beam.",2020,"A correlation was found between grade≥2 tenesmus and increased low-intermediate dose (∼25 Gy) at the posterior beam region, including the posterior rectum and perirectal fat space (PRFS). ","['patients with posteriorly extended lateral beams', '657 patients of the Trans Tasman Radiation Oncology Group 03.04 RADAR trial were deformably registered onto a single exemplar computed tomography dataset']",[],"['grade≥2 rectal bleeding (RB) or tenesmus', 'gastrointestinal toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0243005', 'cui_str': 'Radiation oncology'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034513', 'cui_str': 'Radar'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}]",[],"[{'cui': 'C0018932', 'cui_str': 'Hematochezia'}, {'cui': 'C0232726', 'cui_str': 'Rectal tenesmus'}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}]",,0.0350618,"A correlation was found between grade≥2 tenesmus and increased low-intermediate dose (∼25 Gy) at the posterior beam region, including the posterior rectum and perirectal fat space (PRFS). ","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Marcello', 'Affiliation': 'Department of Physics, University of Western Australia, Crawley, Australia; Department of Radiation Oncology, Sir Charles Gairdner Hospital, Nedlands, Australia. Electronic address: 20739859@student.uwa.edu.au.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Denham', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Kennedy', 'Affiliation': 'Department of Radiation Oncology, Sir Charles Gairdner Hospital, Nedlands, Australia.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Haworth', 'Affiliation': 'School of Physics, University of Sydney, Camperdown, Australia.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Steigler', 'Affiliation': 'Prostate Cancer Trials Group, School of Medicine and Public Health, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Greer', 'Affiliation': 'School of Mathematical and Physical Sciences, University of Newcastle, Callaghan, Australia; Department of Radiation Oncology, Calvary Mater Newcastle, Waratah, Australia.'}, {'ForeName': 'Lois C', 'Initials': 'LC', 'LastName': 'Holloway', 'Affiliation': 'Department of Medical Physics, Liverpool Cancer Centre, Australia; South Western Sydney Clinical School, University of New South Wales, Liverpool, Australia; Centre for Medical Radiation Physics, University of Wollongong, Australia.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Dowling', 'Affiliation': 'School of Mathematical and Physical Sciences, University of Newcastle, Callaghan, Australia; CSIRO, Herston, Australia.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Jameson', 'Affiliation': 'Department of Medical Physics, Liverpool Cancer Centre, Australia; South Western Sydney Clinical School, University of New South Wales, Liverpool, Australia; Centre for Medical Radiation Physics, University of Wollongong, Australia; Cancer Research Team, Ingham Institute for Applied Medical Research, Liverpool, Australia.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Roach', 'Affiliation': 'Department of Medical Physics, Liverpool Cancer Centre, Australia; South Western Sydney Clinical School, University of New South Wales, Liverpool, Australia; Cancer Research Team, Ingham Institute for Applied Medical Research, Liverpool, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Joseph', 'Affiliation': 'School of Surgery, University of Western Australia, Crawley, Australia; 5D Clinics, Claremont, Australia; GenesisCare WA, Wembley, Australia.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Gulliford', 'Affiliation': 'Radiotherapy Department, University College London Hospitals NHS Foundation Trust, United Kingdom; Department of Medical Physics and Biomedical Engineering, University College London, United Kingdom.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Dearnaley', 'Affiliation': 'Academic UroOncology Unit, The Institute of Cancer Research and the Royal Marsden NHS Trust, London, Australia.'}, {'ForeName': 'Mathew R', 'Initials': 'MR', 'LastName': 'Sydes', 'Affiliation': 'MRC Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College, London, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, United Kingdom.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Ebert', 'Affiliation': 'Department of Physics, University of Western Australia, Crawley, Australia; Department of Radiation Oncology, Sir Charles Gairdner Hospital, Nedlands, Australia; 5D Clinics, Claremont, Australia.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.07.048'] 1147,32750143,Clinical Implications of Body Mass Index in Metastatic Breast Cancer Patients Treated With Abemaciclib and Endocrine Therapy.,"BACKGROUND There are limited data regarding the impact of body mass index (BMI) on outcomes in advanced breast cancer, especially in patients treated with endocrine therapy (ET) + cyclin-dependent kinase 4/6 inhibitors. METHODS A pooled analysis of individual patient-level data from MONARCH 2 and 3 trials was performed. Patients were classified according to baseline BMI into underweight (<18.5 kg/m2), normal (18.5-24.9 kg/m2), overweight (25-29.9 kg/m2), and obese (≥30 kg/m2) and divided into 2 treatment groups: abemaciclib + ET vs placebo + ET. The primary endpoint was progression-free survival (PFS) according to BMI in each treatment group. Secondary endpoints were response rate, adverse events according to BMI, and loss of weight (≥5% from baseline) during treatment. RESULTS This analysis included 1138 patients (757 received abemaciclib + ET and 381 placebo + ET). There was no difference in PFS between BMI categories in either group, although normal-weight patients presented a numerically higher benefit with abemaciclib + ET (Pinteraction = .07). Normal and/or underweight patients presented higher overall response rate in the abemaciclib + ET group compared with overweight and/or obese patients (49.4% vs 41.6%, odds ratio = 0.73, 95% confidence interval = 0.54 to 0.99) as well as higher neutropenia frequency (51.0% vs 40.4%, P = .004). Weight loss was more frequent in the abemaciclib + ET group (odds ratio = 3.23, 95% confidence interval = 2.09 to 5.01). CONCLUSIONS Adding abemaciclib to ET prolongs PFS regardless of BMI, showing that overweight or obese patients also benefit from this regimen. Our results elicit the possibility of a better effect of abemaciclib in normal and/or underweight patients compared with overweight and/or obese patients. More studies analyzing body composition parameters in patients under treatment with cyclin-dependent kinase 4/6 inhibitors may further clarify this hypothesis.",2021,"There was no difference in PFS between BMI categories in either groups, although normal weight patients presented a numerically higher benefit with abemaciclib + ET (interaction test p=.07).","['patients treated with endocrine therapy (ET) + CDK 4/6 inhibitors', 'Pooled analysis of individual patient-level data from MONARCH 2 and 3 trials', '1,138 patients (757 received abemaciclib + ET and 381 placebo+ET', 'advanced breast cancer (BC', 'metastatic breast cancer patients treated with', 'Patients were classified according to baseline BMI into underweight (<18.5\u2009kg/m2), normal (18.5-24.9\u2009kg/m2), overweight (25-29.9\u2009kg/m2) and obese (≥30\u2009kg/m2']","['abemaciclib + ET vs. placebo + ET', 'abemaciclib and endocrine therapy']","['Weight loss', 'PFS between BMI categories', 'neutropenia frequency', 'response rate (RR), adverse events (AEs) according to BMI, and loss of weight', 'progression-free survival (PFS', 'overall RR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0243045', 'cui_str': 'cdk Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3852841', 'cui_str': 'abemaciclib'}, {'cui': 'C4708787', 'cui_str': '381'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C4517611', 'cui_str': '18.5'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C3852841', 'cui_str': 'abemaciclib'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",1138.0,0.0959562,"There was no difference in PFS between BMI categories in either groups, although normal weight patients presented a numerically higher benefit with abemaciclib + ET (interaction test p=.07).","[{'ForeName': 'Maria Alice', 'Initials': 'MA', 'LastName': 'Franzoi', 'Affiliation': ""Clinical Trials Support Unit, Institut Jules Bordet, and l'Université Libre de Bruxelles (U.L.B), Brussels, Belgium.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Eiger', 'Affiliation': ""Clinical Trials Support Unit, Institut Jules Bordet, and l'Université Libre de Bruxelles (U.L.B), Brussels, Belgium.""}, {'ForeName': 'Lieveke', 'Initials': 'L', 'LastName': 'Ameye', 'Affiliation': ""Clinical Trials Support Unit, Institut Jules Bordet, and l'Université Libre de Bruxelles (U.L.B), Brussels, Belgium.""}, {'ForeName': 'Noam', 'Initials': 'N', 'LastName': 'Ponde', 'Affiliation': 'Oncology Department, AC Camargo Cancer Center, São Paulo, Brazil.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Caparica', 'Affiliation': ""Clinical Trials Support Unit, Institut Jules Bordet, and l'Université Libre de Bruxelles (U.L.B), Brussels, Belgium.""}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'De Angelis', 'Affiliation': ""Clinical Trials Support Unit, Institut Jules Bordet, and l'Université Libre de Bruxelles (U.L.B), Brussels, Belgium.""}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Brandão', 'Affiliation': ""Clinical Trials Support Unit, Institut Jules Bordet, and l'Université Libre de Bruxelles (U.L.B), Brussels, Belgium.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Desmedt', 'Affiliation': 'Laboratory for Translational Breast Cancer Research, Department of Oncology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Di Cosimo', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Kotecki', 'Affiliation': 'Oncology Department, Institut Jules Bordet, Brussels, Belgium.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Lambertini', 'Affiliation': 'University of Genova and IRCCS Ospedale Policlinico San Martino, Genova, Italy.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Awada', 'Affiliation': 'Oncology Department, Institut Jules Bordet, Brussels, Belgium.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Piccart', 'Affiliation': 'Oncology Department, Institut Jules Bordet, Brussels, Belgium.'}, {'ForeName': 'Evandro de', 'Initials': 'E', 'LastName': 'Azambuja', 'Affiliation': ""Clinical Trials Support Unit, Institut Jules Bordet, and l'Université Libre de Bruxelles (U.L.B), Brussels, Belgium.""}]",Journal of the National Cancer Institute,['10.1093/jnci/djaa116'] 1148,32694001,Effects of Home-Based Physical Exercise on Days at Home and Cost-Effectiveness in Pre-Frail and Frail Persons: Randomized Controlled Trial.,"OBJECTIVES Frailty increases the risks of hospitalization, institutionalization, and death. Our objective was to study the effects of home-based physical exercise on the number of days spent at home among pre-frail and frail persons, versus usual care. In addition, utilization and costs of health care and social services, cost-effectiveness, and health-related quality-of-life (HRQoL) were explored. DESIGN Randomized controlled trial, with year-long supervised exercise for 60 minutes twice a week versus usual care. Follow-up for 24 months after randomization. SETTING AND PARTICIPANTS A sample of 299 home-dwelling persons in South Karelia, Finland. Main inclusion criteria: ≥65 years, meeting at least 1 of the frailty phenotype criteria, Mini-Mental State Examination score ≥17. METHODS Primary outcome, days spent at home over 24 months, was calculated deducting days in inpatient care, in nursing homes, and days after death. HRQoL was assessed (15D questionnaire) at baseline and at 3, 6, and 12 months. Utilization data were retrieved from medical records. RESULTS The participants' mean age was 82.5 (SD 6.3), 75% were women, 61% were pre-frail and 39% frail. After 24 months, there was no difference between groups in days spent at home [incidence rate ratio 1.03; 95% confidence interval (CI) 0.98-1.09]. After 12 months, the costs per person-year were 1.60-fold in the exercise group (95% CI 1.23-1.98), and after 24 months, 1.23-fold (95% CI 0.95-1.50) versus usual care. Over 12 months, the exercise group gained 0.04 quality-adjusted life-years and maintained the baseline 15D level, while the score in the usual care group deteriorated (P for group <.001, time 0.002, interaction 0.004). CONCLUSIONS AND IMPLICATIONS Physical exercise did not increase the number of days spent at home. Exercise prevented deterioration of HRQoL, and in the frail subgroup, all intervention costs were compensated with decreased utilization of other health care and social services over 24 months.",2021,"Exercise prevented deterioration of HRQoL, and in the frail subgroup, all intervention costs were compensated with decreased utilization of other health care and social services over 24 months.","['A sample of 299 home-dwelling persons in South Karelia, Finland', ""participants' mean age was 82.5 (SD 6.3), 75% were women, 61% were pre-frail and 39% frail"", 'Pre-Frail and Frail Persons', 'Main inclusion criteria: ≥65\xa0years, meeting at least 1 of the frailty phenotype criteria, Mini-Mental State Examination score ≥17']","['home-based physical exercise', 'Home-Based Physical Exercise']","['costs per person-year', 'utilization of other health care and social services', 'days spent at home over 24\xa0months, was calculated deducting days in inpatient care, in nursing homes, and days after death', 'HRQoL', 'risks of hospitalization, institutionalization, and death', 'utilization and costs of health care and social services, cost-effectiveness, and health-related quality-of-life (HRQoL', 'number of days spent', 'deterioration of HRQoL']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517887', 'cui_str': '82.5'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021629', 'cui_str': 'Institutionalization'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",299.0,0.150555,"Exercise prevented deterioration of HRQoL, and in the frail subgroup, all intervention costs were compensated with decreased utilization of other health care and social services over 24 months.","[{'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Suikkanen', 'Affiliation': 'Rehabilitation, South Karelia Social and Health Care District, Lappeenranta, Finland; Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland. Electronic address: sara.suikkanen@eksote.fi.'}, {'ForeName': 'Paula K', 'Initials': 'PK', 'LastName': 'Soukkio', 'Affiliation': 'Rehabilitation, South Karelia Social and Health Care District, Lappeenranta, Finland; Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Eeva M', 'Initials': 'EM', 'LastName': 'Aartolahti', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Hannu', 'Initials': 'H', 'LastName': 'Kautiainen', 'Affiliation': 'Unit of Primary Health Care, University of Helsinki, Department of General Practice, and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Sanna M', 'Initials': 'SM', 'LastName': 'Kääriä', 'Affiliation': 'Raatimiehet Oy, Lappeenranta, Finland.'}, {'ForeName': 'Markku T', 'Initials': 'MT', 'LastName': 'Hupli', 'Affiliation': 'Rehabilitation, South Karelia Social and Health Care District, Lappeenranta, Finland.'}, {'ForeName': 'Sarianna', 'Initials': 'S', 'LastName': 'Sipilä', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland; Faculty of Sport and Health Sciences, Gerontology Research Center, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Kaisu H', 'Initials': 'KH', 'LastName': 'Pitkälä', 'Affiliation': 'Unit of Primary Health Care, University of Helsinki, Department of General Practice, and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Katriina T', 'Initials': 'KT', 'LastName': 'Kukkonen-Harjula', 'Affiliation': 'Rehabilitation, South Karelia Social and Health Care District, Lappeenranta, Finland.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2020.06.005'] 1149,33229611,Home-based exercise intervention for caregivers of persons with dementia: a randomised controlled trial: abridged secondary publication.,,2020,,['caregivers of persons with dementia'],['Home-based exercise intervention'],[],"[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.125385,,"[{'ForeName': 'W C', 'Initials': 'WC', 'LastName': 'Chan', 'Affiliation': 'Department of Psychiatry, The University of Hong Kong.'}, {'ForeName': 'L C W', 'Initials': 'LCW', 'LastName': 'Lam', 'Affiliation': 'Department of Psychiatry, The Chinese University of Hong Kong.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Lautenschlager', 'Affiliation': 'Academic Unit for Psychiatry of Old Age, Department of Psychiatry, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Dow', 'Affiliation': 'National Ageing Research Institute, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Ma', 'Affiliation': 'Department of Psychiatry, The Chinese University of Hong Kong.'}]",Hong Kong medical journal = Xianggang yi xue za zhi,[] 1150,32701140,Association of Event-Free and Distant Recurrence-Free Survival With Individual-Level Pathologic Complete Response in Neoadjuvant Treatment of Stages 2 and 3 Breast Cancer: Three-Year Follow-up Analysis for the I-SPY2 Adaptively Randomized Clinical Trial.,"Importance Pathologic complete response (pCR) is a known prognostic biomarker for long-term outcomes. The I-SPY2 trial evaluated if the strength of this clinical association persists in the context of a phase 2 neoadjuvant platform trial. Objective To evaluate the association of pCR with event-free survival (EFS) and pCR with distant recurrence-free survival (DRFS) in subpopulations of women with high-risk operable breast cancer treated with standard therapy or one of several novel agents. Design, Setting, and Participants Multicenter platform trial of women with operable clinical stage 2 or 3 breast cancer with no prior surgery or systemic therapy for breast cancer; primary tumors were 2.5 cm or larger. Women with tumors that were ERBB2 negative/hormone receptor (HR) positive with low 70-gene assay score were excluded. Participants were adaptively randomized to one of several different investigational regimens or control therapy within molecular subtypes from March 2010 through 2016. The analysis included participants with follow-up data available as of February 26, 2019. Interventions Standard-of-care neoadjuvant therapy consisting of taxane treatment with or without (as control) one of several investigational agents or combinations followed by doxorubicin and cyclophosphamide. Main Outcomes and Measures Pathologic complete response and 3-year EFS and DRFS. Results Of the 950 participants (median [range] age, 49 [23-77] years), 330 (34.7%) achieved pCR. Three-year EFS and DRFS for patients who achieved pCR were both 95%. Hazard ratios for pCR vs non-pCR were 0.19 for EFS (95% CI, 0.12-0.31) and 0.21 for DRFS (95% CI, 0.13-0.34) and were similar across molecular subtypes, varying from 0.14 to 0.18 for EFS and 0.10 to 0.20 for DRFS. Conclusions and Relevance The 3-year outcomes from the I-SPY2 trial show that, regardless of subtype and/or treatment regimen, including 9 novel therapeutic combinations, achieving pCR after neoadjuvant therapy implies approximately an 80% reduction in recurrence rate. The goal of the I-SPY2 trial is to rapidly identify investigational therapies that may improve pCR when validated in a phase 3 confirmatory trial. Whether pCR is a validated surrogate in the sense that a therapy that improves pCR rate can be assumed to also improve long-term outcome requires further study. Trial Registration ClinicalTrials.gov Identifier: NCT01042379.",2020,"Hazard ratios for pCR vs non-pCR were 0.19 for EFS (95% CI, 0.12-0.31) and 0.21 for DRFS (95% CI, 0.13-0.34) and were similar across molecular subtypes, varying from 0.14 to 0.18 for EFS and 0.10 to 0.20 for DRFS. ","['participants with follow-up data available as of February 26, 2019', 'Neoadjuvant Treatment of Stages 2 and 3 Breast Cancer', 'women with operable clinical stage 2 or 3 breast cancer with no prior surgery or systemic therapy for breast cancer; primary tumors were 2.5 cm or larger', 'subpopulations of women with high-risk operable breast cancer treated with standard therapy or one of several novel agents', '950 participants (median [range] age, 49 [23-77] years), 330 (34.7%) achieved pCR']","['taxane', 'pCR', 'doxorubicin and cyclophosphamide', 'control therapy']","['Hazard ratios', 'ERBB2 negative/hormone receptor (HR) positive with low 70-gene assay score', 'pCR with event-free survival (EFS) and pCR with distant recurrence-free survival (DRFS', 'pCR rate', 'Measures\n\n\nPathologic complete response and 3-year EFS and DRFS', 'recurrence rate']","[{'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C0205563', 'cui_str': 'Clinical stage finding'}, {'cui': 'C0455610', 'cui_str': 'H/O: surgery'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C1257890', 'cui_str': 'Group'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C4708800', 'cui_str': '950'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]","[{'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.184284,"Hazard ratios for pCR vs non-pCR were 0.19 for EFS (95% CI, 0.12-0.31) and 0.21 for DRFS (95% CI, 0.13-0.34) and were similar across molecular subtypes, varying from 0.14 to 0.18 for EFS and 0.10 to 0.20 for DRFS. ","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Yee', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'DeMichele', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Yau', 'Affiliation': 'Department of Surgery, University of California, San Francisco.'}, {'ForeName': 'Claudine', 'Initials': 'C', 'LastName': 'Isaacs', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC.'}, {'ForeName': 'W Fraser', 'Initials': 'WF', 'LastName': 'Symmans', 'Affiliation': 'Department of Pathology, University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Kathy S', 'Initials': 'KS', 'LastName': 'Albain', 'Affiliation': 'Loyola University Chicago Stritch School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Yunn-Yi', 'Initials': 'YY', 'LastName': 'Chen', 'Affiliation': 'Department of Pathology, University of California, San Francisco.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Krings', 'Affiliation': 'Department of Pathology, University of California, San Francisco.'}, {'ForeName': 'Shi', 'Initials': 'S', 'LastName': 'Wei', 'Affiliation': 'Department of Pathology, University of Alabama Birmingham.'}, {'ForeName': 'Shuko', 'Initials': 'S', 'LastName': 'Harada', 'Affiliation': 'Department of Pathology, University of Alabama Birmingham.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Datnow', 'Affiliation': 'Department of Pathology, University of California, San Diego.'}, {'ForeName': 'Oluwole', 'Initials': 'O', 'LastName': 'Fadare', 'Affiliation': 'Department of Pathology, University of California, San Diego.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Klein', 'Affiliation': 'Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Pambuccian', 'Affiliation': 'Department of Pathology, Loyola University Chicago Stritch School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Beiyun', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Mayo Clinic Rochester, Rochester, Minnesota.'}, {'ForeName': 'Kathi', 'Initials': 'K', 'LastName': 'Adamson', 'Affiliation': 'Department of Pathology, Swedish Cancer Institute, Seattle, Washington.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Sams', 'Affiliation': 'Department of Pathology, University of Colorado, Denver.'}, {'ForeName': 'Paulette', 'Initials': 'P', 'LastName': 'Mhawech-Fauceglia', 'Affiliation': 'Keck School of Medicine, University of Southern California, Los Angeles.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Magliocco', 'Affiliation': 'Department of Pathology, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Feldman', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Rendi', 'Affiliation': 'Department of Anatomic Pathology, University of Washington, Seattle.'}, {'ForeName': 'Husain', 'Initials': 'H', 'LastName': 'Sattar', 'Affiliation': 'Department of Pathology, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Zeck', 'Affiliation': 'Department of Pathology, Georgetown University, Washington, DC.'}, {'ForeName': 'Idris T', 'Initials': 'IT', 'LastName': 'Ocal', 'Affiliation': 'Laboratory Medicine and Pathology, Mayo Clinic Scottsdale, Scottsdale, Arizona.'}, {'ForeName': 'Ossama', 'Initials': 'O', 'LastName': 'Tawfik', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of Kansas, Lawrence.'}, {'ForeName': 'Lauren Grasso', 'Initials': 'LG', 'LastName': 'LeBeau', 'Affiliation': 'Department of Pathology, University of Arizona, Tucson.'}, {'ForeName': 'Sunati', 'Initials': 'S', 'LastName': 'Sahoo', 'Affiliation': 'Department of Pathology, University of Texas Southwestern, Dallas.'}, {'ForeName': 'Tuyethoa', 'Initials': 'T', 'LastName': 'Vinh', 'Affiliation': 'Inova Pathology Institute, Inova Health System, Falls Church, Virginia.'}, {'ForeName': 'A Jo', 'Initials': 'AJ', 'LastName': 'Chien', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Forero-Torres', 'Affiliation': 'Division of Hematology and Oncology, University of Alabama Birmingham.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Stringer-Reasor', 'Affiliation': 'Division of Hematology and Oncology, University of Alabama Birmingham.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Wallace', 'Affiliation': 'Department of Surgery, University of California, San Diego.'}, {'ForeName': 'Lajos', 'Initials': 'L', 'LastName': 'Pusztai', 'Affiliation': 'Medical Oncology, Yale Cancer Center, New Haven, Connecticut.'}, {'ForeName': 'Judy C', 'Initials': 'JC', 'LastName': 'Boughey', 'Affiliation': 'Department of Surgery, Mayo Clinic Rochester, Rochester, Minnesota.'}, {'ForeName': 'Erin D', 'Initials': 'ED', 'LastName': 'Ellis', 'Affiliation': 'Medical Oncology, Swedish Cancer Institute, Seattle, Washington.'}, {'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'Elias', 'Affiliation': 'Department of Medicine, University of Colorado, Denver.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Medical Oncology, Keck School of Medicine, University of Southern California, Los Angeles.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Lang', 'Affiliation': 'Surgery, Keck School of Medicine, University of Southern California, Los Angeles.'}, {'ForeName': 'Hyo S', 'Initials': 'HS', 'LastName': 'Han', 'Affiliation': 'Medical Oncology, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Clark', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Nanda', 'Affiliation': 'Hematology and Oncology, University of Chicago Medical Center, Chicago, Illinois.'}, {'ForeName': 'Donald W', 'Initials': 'DW', 'LastName': 'Northfelt', 'Affiliation': 'Medical Oncology, Mayo Clinic Scottsdale, Scottsdale, Arizona.'}, {'ForeName': 'Qamar J', 'Initials': 'QJ', 'LastName': 'Khan', 'Affiliation': 'Medical Oncology, University of Kansas Medical Center, Lawrence.'}, {'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Viscusi', 'Affiliation': 'Hematology/Oncology, University of Arizona, Tucson.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Euhus', 'Affiliation': 'Department of Surgery, Johns Hopkins Medicine, Baltimore, Maryland.'}, {'ForeName': 'Kirsten K', 'Initials': 'KK', 'LastName': 'Edmiston', 'Affiliation': 'Inova Schar Cancer Institute, Fairfax, Virginia.'}, {'ForeName': 'Stephen Y', 'Initials': 'SY', 'LastName': 'Chui', 'Affiliation': 'Genentech, South San Francisco, California.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Kemmer', 'Affiliation': 'Knight Cancer Institute, Oregon Health & Science University, Portland.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco.'}, {'ForeName': 'Minetta C', 'Initials': 'MC', 'LastName': 'Liu', 'Affiliation': 'Department of Oncology, Mayo Clinic Rochester, Rochester, Minnesota.'}, {'ForeName': 'Olufunmilayo', 'Initials': 'O', 'LastName': 'Olopade', 'Affiliation': 'Hematology and Oncology, University of Chicago Medical Center, Chicago, Illinois.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Leyland-Jones', 'Affiliation': 'Avera Cancer Institute, Sioux Falls, South Dakota.'}, {'ForeName': 'Debasish', 'Initials': 'D', 'LastName': 'Tripathy', 'Affiliation': 'Department of Breast Medical Oncology, University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Stacy L', 'Initials': 'SL', 'LastName': 'Moulder', 'Affiliation': 'Department of Breast Medical Oncology, University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Schwab', 'Affiliation': 'Medical Oncology, University of California, San Diego.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Lo', 'Affiliation': 'Medical Oncology, Loyola University Chicago Stritch School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Helsten', 'Affiliation': 'Medical Oncology, University of California, San Diego.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Beckwith', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Haugen', 'Affiliation': 'National Breast Cancer Coalition, Washington, DC.'}, {'ForeName': 'Nola M', 'Initials': 'NM', 'LastName': 'Hylton', 'Affiliation': 'Department of Radiology and Biomedical Imaging, University of California, San Francisco.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': ""Van't Veer"", 'Affiliation': 'Department of Laboratory Medicine, University of California, San Francisco.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Perlmutter', 'Affiliation': 'Gemini Group, Ann Arbor, Michigan.'}, {'ForeName': 'Michelle E', 'Initials': 'ME', 'LastName': 'Melisko', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'Quantum Leap Healthcare Collaborative, San Francisco, California.'}, {'ForeName': 'Garry', 'Initials': 'G', 'LastName': 'Peterson', 'Affiliation': 'Department of Surgery, University of California, San Francisco.'}, {'ForeName': 'Adam L', 'Initials': 'AL', 'LastName': 'Asare', 'Affiliation': 'Quantum Leap Healthcare Collaborative, San Francisco, California.'}, {'ForeName': 'Meredith B', 'Initials': 'MB', 'LastName': 'Buxton', 'Affiliation': 'Berry Consultants, LLC, Austin, Texas.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Paoloni', 'Affiliation': 'Berry Consultants, LLC, Austin, Texas.'}, {'ForeName': 'Julia L', 'Initials': 'JL', 'LastName': 'Clennell', 'Affiliation': 'Berry Consultants, LLC, Austin, Texas.'}, {'ForeName': 'Gillian L', 'Initials': 'GL', 'LastName': 'Hirst', 'Affiliation': 'Department of Surgery, University of California, San Francisco.'}, {'ForeName': 'Ruby', 'Initials': 'R', 'LastName': 'Singhrao', 'Affiliation': 'Department of Surgery, University of California, San Francisco.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Steeg', 'Affiliation': 'Department of Surgery, University of California, San Francisco.'}, {'ForeName': 'Jeffrey B', 'Initials': 'JB', 'LastName': 'Matthews', 'Affiliation': 'Department of Surgery, University of California, San Francisco.'}, {'ForeName': 'Smita M', 'Initials': 'SM', 'LastName': 'Asare', 'Affiliation': 'Quantum Leap Healthcare Collaborative, San Francisco, California.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Sanil', 'Affiliation': 'Berry Consultants, LLC, Austin, Texas.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Berry', 'Affiliation': 'Berry Consultants, LLC, Austin, Texas.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Esserman', 'Affiliation': 'Department of Surgery, University of California, San Francisco.'}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Berry', 'Affiliation': 'Berry Consultants, LLC, Austin, Texas.'}]",JAMA oncology,['10.1001/jamaoncol.2020.2535'] 1151,32703307,Randomized control trial of advanced cancer patients at a private hospital in Kenya and the impact of dignity therapy on quality of life.,"BACKGROUND Palliative care is a modality of treatment that addresses physical, psychological and spiritual symptoms. Dignity therapy, a form of psychotherapy, was developed by Professor Harvey Chochinov, MD in 2005.The aim of the study was to assess the effect of one session of dignity therapy on quality of life in advanced cancer patients. METHODS This was a randomized control trial of 144 patients (72 in each arm) randomized into group 1 (intervention arm) and group 2 (control arm). Baseline ESAS scores were determined in both arms following which group 1 received Dignity therapy while Group 2 received usual care only. Data collected was presented as printed (Legacy) documents to group 1 participants. These documents were a summary of previous discussions held. Post intervention ESAS scores were obtained in both groups after 6 weeks. Analysis was based on the intention to treat principle and descriptive statistics computed. The main outcome was symptom distress scores on the ESAS (summated out of 100 and symptom specific scores out of 10). The student T-test was used to test for difference in ESAS scores at follow up and graphs were computed for common cancers and comorbidities. RESULTS Of the 144 (72 patients in each arm) patients randomized, 70%were female while 30% were male with a mean age of 50 years. At 6 weeks, 11 patients were lost to follow up, seven died and 126 completed the study. The commonly encountered cancers were gastrointestinal cancers (43%, p = 0.29), breast cancer (27.27% p = 0.71) and gynaecologic cancers (23% p = 0.35). Majority of the patients i.e. 64.3% had no comorbidities. The primary analysis results showed higher scores for the DT group (change in mean = 1.57) compared to the UC group (change in mean = - 0.74) yielding a non-statistically significant difference in change scores of 1.44 (p = 0.670; 95% CI - 5.20 to 8.06). After adjusting for baseline scores, the mean (summated) symptom distress score was not significant (GLM p = 0.78). Dignity therapy group showed a trend towards statistical improvement in anxiety (p = 0.059). The largest effects seen were in improvement of appetite, lower anxiety and improved wellbeing (Cohen effect size 0.3, 0.5 and 0.31 respectively). CONCLUSION Dignity therapy showed no statistical improvement in overall quality of life. Symptom improvement was seen in anxiety and this was a trend towards statistical significance (p = 0.059). TRIAL REGISTRATION Trial registration number PACTR201604001447244 retrospectively registered with Pan African Clinical trials on 28th January 2016.",2020,"The largest effects seen were in improvement of appetite, lower anxiety and improved wellbeing (Cohen effect size 0.3, 0.5 and 0.31 respectively). ","['Of the 144 (72 patients in each arm', '11 patients were lost to follow up, seven died and 126 completed the study', 'advanced cancer patients', '144 patients (72 in each arm', 'advanced cancer patients at a private hospital in Kenya', '70%were female while 30% were male with a mean age of 50\u2009years']","['Dignity therapy', 'dignity therapy']","['quality of life', 'breast cancer', 'Baseline ESAS scores', 'mean (summated) symptom distress score', 'anxiety', 'appetite, lower anxiety and improved wellbeing', 'gynaecologic cancers', 'overall quality of life', 'ESAS scores', 'symptom distress scores', 'gastrointestinal cancers']","[{'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0033173', 'cui_str': 'Private hospital'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4704841', 'cui_str': 'Dignity'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3472649', 'cui_str': 'Edmonton symptom assessment system'}, {'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}]",144.0,0.182917,"The largest effects seen were in improvement of appetite, lower anxiety and improved wellbeing (Cohen effect size 0.3, 0.5 and 0.31 respectively). ","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Weru', 'Affiliation': 'Palliative care, AKUHN, Nairobi, Kenya. john.weru@aku.edu.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Gatehi', 'Affiliation': 'MMED INT. Med, Nairobi, Kenya.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Musibi', 'Affiliation': 'Oncology, Kenyatta National Hospital, Nairobi, Kenya.'}]",BMC palliative care,['10.1186/s12904-020-00614-0'] 1152,32701826,Body Composition Changes in Response to Moderate- or High-Intensity Exercise Among Older Adults With or Without HIV Infection.,"BACKGROUND People with HIV (PWH) are at an increased risk for adiposity and sarcopenia, despite effective antiretroviral therapy. Our objective was to compare the effects of prescribed exercise on body composition in older PWH and uninfected controls. SETTING Academic medical center. METHODS Sedentary PWH (n = 27) and uninfected controls (n = 28) aged 50-75 years completed 24 weeks of cardiovascular and resistance exercise. Participants completed 12 weeks of moderate-intensity exercise and then were randomized to moderate- or high-intensity exercise for 12 additional weeks. Total lean (LEAN) and fat mass (FAT), and visceral adipose tissue area (VAT) were measured using dual-energy x-ray absorptiometry at baseline and 24 weeks; baseline and intervention differences were compared by HIV serostatus using multivariable regression analyses adjusted for baseline values, age, and exercise adherence. RESULTS At baseline, PWH had significantly lower FAT (P = 0.003), but no significant differences in LEAN or VAT compared with controls (P > 0.20). Changes over 24 weeks were not significantly different by HIV serostatus, although controls tended to gain more LEAN (0.8 kg; range, 0-1.6 kg; P = 0.04] than PWH (0.6 kg; range, -0.2 to 1.4 kg; P = 0.12) and lose less FAT and VAT (controls: (-0.9 kg; range, -1.8 to 0.0 kg and -10.3 cm; range, -19.6, 1.0) cm; both P = 0.03 vs PWH: -2.0 kg; range, -2.9 to -1.1 kg and -17.7 cm; range, -27.1 to -8.2 cm; both P < 0.001). Exercise intensity differences were not apparent for LEAN, FAT, or VAT. CONCLUSIONS Exercise reduced total and visceral fat in older PWH and controls. Minimal gains in lean mass suggest that greater emphasis on resistance exercise may be needed to more effectively increase muscle in PWH.",2020,"At baseline, PWH had significantly lower FAT (P=0.003), but no significant differences in LEAN or VAT compared to controls (P>0.20).","['Participants completed 12 weeks of moderate-intensity exercise', 'People with HIV (PWH', 'Academic medical center METHODS:: Sedentary PWH (n=27) and uninfected controls (n=28) aged 50-75 completed 24 weeks of', 'Older Adults with or without HIV Infection', 'older PWH and uninfected controls']","['moderate- or high-intensity exercise', 'Exercise', 'cardiovascular and resistance exercise']","['Total lean (LEAN) and fat mass (FAT) and visceral adipose tissue area (VAT', 'LEAN or VAT', 'FAT and VAT', 'FAT', 'total and visceral fat']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0042427', 'cui_str': 'Vatican City'}]",,0.152703,"At baseline, PWH had significantly lower FAT (P=0.003), but no significant differences in LEAN or VAT compared to controls (P>0.20).","[{'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Jankowski', 'Affiliation': 'University of Colorado College of Nursing, Aurora, CO.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Mawhinney', 'Affiliation': 'Department of Biostatistics, University of Colorado Anschutz Medical Campus, School of Public Health, Aurora, CO.'}, {'ForeName': 'Melissa P', 'Initials': 'MP', 'LastName': 'Wilson', 'Affiliation': 'Department of Biostatistics, University of Colorado Anschutz Medical Campus, School of Public Health, Aurora, CO.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Campbell', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Wendy M', 'Initials': 'WM', 'LastName': 'Kohrt', 'Affiliation': 'Department of Medicine, Division of Geriatric Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Schwartz', 'Affiliation': 'Department of Medicine, Division of Geriatric Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Todd T', 'Initials': 'TT', 'LastName': 'Brown', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Diabetes, & Metabolism, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Kristine M', 'Initials': 'KM', 'LastName': 'Erlandson', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Colorado Anschutz Medical Campus, Aurora, CO.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002443'] 1153,32707342,"Inter- and Intra-individual Variation, and Limited Prognostic Utility, of Serum Alkaline Phosphatase in a Trial of Patients With Primary Sclerosing Cholangitis.","BACKGROUND & AIMS Serum alkaline phosphatase (ALP) and the enhanced liver fibrosis (ELF) score are used as endpoints in trials of patients with primary sclerosing cholangitis (PSC). We aimed to quantify inter- and intra-individual variation in levels of ALP and the ELF score over time, and evaluated their association with fibrosis progression. METHODS We analyzed data from 234 patients with large-duct PSC enrolled in a 2-year, phase 2b placebo-controlled trial of simtuzumab. Participants were assessed by laboratory tests every 4 weeks, and liver biopsies collected at time of screening, week 48, and week 96. RESULTS Serum levels of ALP and ELF scores did not differ significantly between simtuzumab and placebo groups, so the data were pooled. Median per-patient variations in ALP between clinic visits were approximately 12% over 12 weeks, 20% over 48 weeks, and 20% over 96 weeks. Reductions, unrelated to study intervention, of more than 40% in ALP were observed in 10.9% of patients with baseline activity greater than 2-fold the upper limit of normal (ULN) and 12.5% of patients with more than 3-fold the ULN at 1 year. At 2 years, reductions of more than 40% in ALP were observed in 15.8% of patients with baseline activity greater than 2-fold the ULN and 17.9% of patients with more than 3-fold the ULN. Among the 209 patients with Ishak fibrosis stage 0-4 at baseline, serum ALP activity did not associate with development of cirrhosis or with a 2-point increase in fibrosis stage at 2 years. In contrast, the median per-patient variation in ELF scores between clinic visits was approximately 3% over 12 weeks, 4% over 48 weeks, and 4% over 96 weeks. Elevated ELF scores at baseline and at weeks 12, 24 and 48, each associated with development of cirrhosis at 2 years (odds ratio >2.75; P < .01 for all timepoints). ELF scores at baseline and weeks 12, 24 and 48, also associated with a 2-point increase in fibrosis stage at 2 years (odds ratios all greater than 2; P < .01 for all timepoints). CONCLUSIONS In an analysis of data from patients with large-duct PSC enrolled in a prospective trial, we found large interindividual and intraindividual variations in serum ALP activity. Serum ALP activity did not associate with disease progression over a 2-year period. Variations in ELF score were smaller, and scores determined at multiple timepoints associated with fibrosis progression and development of cirrhosis.",2020,"RESULTS Serum levels of ALP and ELF scores did not differ significantly between simtuzumab and placebo groups, so the data were pooled.","['Patients With Primary Sclerosing Cholangitis', 'patients with large-duct PSC', '209 patients with Ishak fibrosis stage 0-4 at baseline', '234 patients with large-duct PSC enrolled in a 2-year, phase 2b', 'patients with primary sclerosing cholangitis (PSC']","['simtuzumab', 'placebo']","['ELF scores', 'fibrosis stage', 'ALP', 'ELF score', 'upper limit of normal (ULN', 'Increased ELF scores', 'Serum levels of ALP', 'fibrosis progression and development of cirrhosis', 'serum levels of ALP', 'Serum levels of ALP and ELF scores', 'median per-patient variation in ELF scores between clinic visits']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0566602', 'cui_str': 'Primary sclerosing cholangitis'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0687028', 'cui_str': 'Duct (organ) structure'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0441763', 'cui_str': 'Stage 0'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C4054022', 'cui_str': 'simtuzumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}]",234.0,0.0822935,"RESULTS Serum levels of ALP and ELF scores did not differ significantly between simtuzumab and placebo groups, so the data were pooled.","[{'ForeName': 'Palak J', 'Initials': 'PJ', 'LastName': 'Trivedi', 'Affiliation': 'National Institute for Health Research (NIHR) Birmingham Biomedical Research Centre, Birmingham, United Kingdom; University Hospitals Birmingham, Birmingham, United Kingdom; Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, United Kingdom; Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom. Electronic address: p.j.trivedi@bham.ac.uk.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Muir', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Levy', 'Affiliation': 'University of Miami, Miami, Florida.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Bowlus', 'Affiliation': 'University of California Davis, Davis, California.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Manns', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'Gilead Sciences, Inc, Foster City, California.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Crans', 'Affiliation': 'Gilead Sciences, Inc, Foster City, California.'}, {'ForeName': 'Chuhan', 'Initials': 'C', 'LastName': 'Chung', 'Affiliation': 'Gilead Sciences, Inc, Foster City, California.'}, {'ForeName': 'G Mani', 'Initials': 'GM', 'LastName': 'Subramanian', 'Affiliation': 'Gilead Sciences, Inc, Foster City, California.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Myers', 'Affiliation': 'Gilead Sciences, Inc, Foster City, California.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Goodman', 'Affiliation': 'Inova Fairfax Hospital, Falls Church, Virginia.'}, {'ForeName': 'Naga', 'Initials': 'N', 'LastName': 'Chalasani', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Vierling', 'Affiliation': 'Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Indra Neil', 'Initials': 'IN', 'LastName': 'Guha', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Gideon M', 'Initials': 'GM', 'LastName': 'Hirschfield', 'Affiliation': 'Toronto Centre for Liver Disease, University Health Network, University of Toronto, Toronto, ON, Canada. Electronic address: Hirsch.hirschfield@uhn.ca.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.07.032'] 1154,32716061,Impact of different surgical protocols on dimensional changes of free soft tissue autografts: A randomized controlled trial.,"BACKGROUND To determine if there is a difference in the amount of shrinkage during healing of free soft tissue autografts (FSTAs) using different surgical techniques-suturing the vestibular flap margin apically to the base of the recipient bed versus leaving the flap margin free and unsutured. METHODS Twenty-eight patients with mucogingival defects requiring FSTAs were recruited and enrolled in the study. Patients were randomized into test and control groups (14 per group) and received ≥1 FSTAs on non-molar mandibular teeth. In the test group the mucosal flap margin was sutured apically to the periosteum at the base of the graft; whereas, the mucosal flap margin in the control group was left free. Graft dimensional measurements were taken at time of surgery, then at 1, 3, and 6 months post-surgery. RESULTS Thirty-five grafts were performed (15 test, 20 control). All FSTAs experienced vertical shrinkage after 6 months, but there was no significant difference (P = 0.51) in the mean amount of shrinkage after 6 months between the test (23.20% ± 20.88%) and control (21.10% ± 21.88%) groups. There was significantly greater horizontal shrinkage in the test (loss of 7.59% ± 10.20%) compared with the control (small gain of 0.32% ± 4.20%) group (P = 0.01). CONCLUSIONS The findings suggest that there is similar vertical shrinkage when performing FSTA surgery when the mucosal flap margin is left free and unsutured when compared with leaving the flap margin free.",2021,"All FSTAs experienced vertical shrinkage after 6 months, but there was no significant difference (P = 0.51) in the mean amount of shrinkage after 6 months between the test (23.20 ± 20.88%) and control (21.10 ± 21.88%) groups.",['Twenty-eight patients with mucogingival defects requiring FSTAs were recruited and enrolled in the study'],['one or more FSTAs on non-molar mandibular teeth'],"['dimensional changes of free soft tissue autografts', 'mean amount of shrinkage', 'vertical shrinkage', 'mucosal flap margin', 'horizontal shrinkage']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0227029', 'cui_str': 'Structure of mandibular teeth'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0729268', 'cui_str': 'Mucosal flap'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}]",35.0,0.0387735,"All FSTAs experienced vertical shrinkage after 6 months, but there was no significant difference (P = 0.51) in the mean amount of shrinkage after 6 months between the test (23.20 ± 20.88%) and control (21.10 ± 21.88%) groups.","[{'ForeName': 'Akemi', 'Initials': 'A', 'LastName': 'Arzouman', 'Affiliation': 'Department of Periodontics, UT Health San Antonio School of Dentistry, San Antonio, TX.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Deas', 'Affiliation': 'Department of Periodontics, UT Health San Antonio School of Dentistry, San Antonio, TX.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Mills', 'Affiliation': 'Department of Periodontics, UT Health San Antonio School of Dentistry, San Antonio, TX.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Huynh-Ba', 'Affiliation': 'Department of Periodontics, UT Health San Antonio School of Dentistry, San Antonio, TX.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Prihoda', 'Affiliation': 'Department of Pathology, UT Health San Antonio, San Antonio, TX.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Mealey', 'Affiliation': 'Department of Periodontics, UT Health San Antonio School of Dentistry, San Antonio, TX.'}]",Journal of periodontology,['10.1002/JPER.20-0033'] 1155,32720085,Losing my loss aversion: The effects of current and past environment on the relative sensitivity to losses and gains.,"It is often assumed that most people are loss averse, placing more weight on losses than commensurate gains; however, some research identifies variability in loss sensitivity that reflects features of the environment. We examined this plasticity in loss sensitivity by manipulating the size and distribution of possible outcomes in a set of mixed gambles, and assessing individual stability in loss sensitivity. In each of two sessions, participants made accept-reject decisions for 64 mixed-outcome gambles. Participants were randomly assigned to conditions defined by the relative range of losses and gains (wider range of losses vs. wider range of gains), and the currency-units at stake ('pennies' vs. 'pounds'). Participants showed modest but non-trivial consistency in their sensitivity to losses; though loss sensitivity also varied substantially with our manipulations. When possible gains had greater range than possible losses, most participants were loss averse; however, when possible losses had the greater range, reverse loss aversion was the norm (i.e., more weight on gains than losses). This is consistent with decision-by-sampling theory, whereby an outcome's rank within a consideration-set determines its value, but can also be explained by the gamble's expected-value rank within the decision-set, or by adapting aspirations to the decision-environment. Loss aversion was also reduced in the second session of decisions when the stakes had been higher in the previous session. This illustrates the influence of prior context on current sensitivity to losses, and suggests a role for idiosyncratic experiences in the development of individual differences in loss sensitivity.",2020,Participants showed modest but non-trivial consistency in their sensitivity to losses; though loss sensitivity also varied substantially with our manipulations.,['Losing my loss aversion'],[],['Loss aversion'],"[{'cui': 'C0233496', 'cui_str': 'Aversion'}]",[],"[{'cui': 'C0233496', 'cui_str': 'Aversion'}]",,0.0406523,Participants showed modest but non-trivial consistency in their sensitivity to losses; though loss sensitivity also varied substantially with our manipulations.,"[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Rakow', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience - Department of Psychology, King's College London, London, UK. tim.rakow@kcl.ac.uk.""}, {'ForeName': 'Nga Yiu', 'Initials': 'NY', 'LastName': 'Cheung', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience - Department of Psychology, King's College London, London, UK.""}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Restelli', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience - Department of Psychology, King's College London, London, UK.""}]",Psychonomic bulletin & review,['10.3758/s13423-020-01775-y'] 1156,32725411,10-Year Paclitaxel Dose-Related Outcomes of Drug-Eluting Stents Treated Below the Knee in Patients with Chronic Limb-Threatening Ischemia (The PADI Trial).,"PURPOSE Recently, two meta-analyses concluded that there appears to be an increased risk of long-term mortality of paclitaxel-coated balloons and stents in the superficial femoral and popliteal artery, and paclitaxel-coated balloons below the knee. In this post hoc study of the PADI Trial, we investigated the long-term safety of first-generation paclitaxel-coated drug-eluting stents (DES) below the knee and the dose-mortality relationships of paclitaxel in patients with chronic limb-threatening ischemia (CLI). MATERIALS AND METHODS The PADI Trial compared paclitaxel-coated DES with percutaneous transluminal angioplasty with bail-out bare-metal stents (PTA ± BMS) in patients with CLI treated below the knee. Follow-up was extended to 10 years after the first inclusion, and survival analyses were performed. In addition, dose-related mortality and dose per patient weight-related mortality relations were examined. RESULTS A total of 140 limbs in 137 patients were included in the PADI Trial. Ten years after the first inclusion, 109/137 (79.6%) patients had died. There was no significant difference between mortality in the DES group compared with the PTA ± BMS group (Log-rank p value = 0.12). No specific dose-related mortality (HR 1.00, 95% CI 0.99-1.00, p = 0.99) or dose per weight mortality (HR 1.05, 95% CI 0.93-1.18, p = 0.46) relationships were identified in the Cox-proportional Hazard models or by Kaplan-Meier survival analyses. CONCLUSIONS There is a poor 10-year survival in both paclitaxel-coated DES and PTA ± BMS in patients with CLI treated below the knee. No dose-related adverse effects of paclitaxel-coated DES were observed in our study of patients with CLI treated below the knee. LEVEL OF EVIDENCE The PADI Trial: level 1, randomized clinical trial.",2020,There was no significant difference between mortality in the DES group compared with the PTA ± BMS group (Log-rank p value = 0.12).,"['patients with chronic limb-threatening ischemia (CLI', 'A total of 140 limbs in 137 patients were included in the PADI Trial', 'patients with CLI treated below the knee', 'Patients with Chronic Limb-Threatening Ischemia (The PADI Trial']","['paclitaxel-coated DES with percutaneous transluminal angioplasty with bail-out bare-metal stents (PTA\u2009±\u2009BMS', 'first-generation paclitaxel-coated drug-eluting stents (DES', 'paclitaxel', 'paclitaxel-coated DES']","['weight mortality', 'specific dose-related mortality', 'risk of long-term mortality', 'died', 'mortality', '10-year survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0304222', 'cui_str': 'Drug coating'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C2936666', 'cui_str': 'Percutaneous transluminal angioplasty'}, {'cui': 'C2825200', 'cui_str': 'Bare metal stent'}, {'cui': 'C0015522', 'cui_str': 'Coagulation factor XI'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",137.0,0.0645289,There was no significant difference between mortality in the DES group compared with the PTA ± BMS group (Log-rank p value = 0.12).,"[{'ForeName': 'Louise C D', 'Initials': 'LCD', 'LastName': 'Konijn', 'Affiliation': 'Department of Radiology, Haga Teaching Hospital, Leyweg 275, 2545CH/PO box 40551, The Hague, The Netherlands.'}, {'ForeName': 'Thijs', 'Initials': 'T', 'LastName': 'Wakkie', 'Affiliation': 'Department of Radiology, Haga Teaching Hospital, Leyweg 275, 2545CH/PO box 40551, The Hague, The Netherlands.'}, {'ForeName': 'Marlon I', 'Initials': 'MI', 'LastName': 'Spreen', 'Affiliation': 'Department of Radiology, Haga Teaching Hospital, Leyweg 275, 2545CH/PO box 40551, The Hague, The Netherlands.'}, {'ForeName': 'Pim A', 'Initials': 'PA', 'LastName': 'de Jong', 'Affiliation': 'Department of Radiology, University Medical Center Utrecht and Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Lukas C', 'Initials': 'LC', 'LastName': 'van Dijk', 'Affiliation': 'Department of Radiology, Haga Teaching Hospital, Leyweg 275, 2545CH/PO box 40551, The Hague, The Netherlands.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Wever', 'Affiliation': 'Department of Vascular Surgery, Haga Teaching Hospital, Leyweg 275, 2545CH/PO box 40551, The Hague, The Netherlands.'}, {'ForeName': 'Hugo T C', 'Initials': 'HTC', 'LastName': 'Veger', 'Affiliation': 'Department of Vascular Surgery, Haga Teaching Hospital, Leyweg 275, 2545CH/PO box 40551, The Hague, The Netherlands.'}, {'ForeName': 'Randolph G', 'Initials': 'RG', 'LastName': 'Statius van Eps', 'Affiliation': 'Department of Vascular Surgery, Haga Teaching Hospital, Leyweg 275, 2545CH/PO box 40551, The Hague, The Netherlands.'}, {'ForeName': 'Willem P Th M', 'Initials': 'WPTM', 'LastName': 'Mali', 'Affiliation': 'Department of Radiology, University Medical Center Utrecht and Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'van Overhagen', 'Affiliation': 'Department of Radiology, Haga Teaching Hospital, Leyweg 275, 2545CH/PO box 40551, The Hague, The Netherlands. h.voverhagen@hagaziekenhuis.nl.'}]",Cardiovascular and interventional radiology,['10.1007/s00270-020-02602-6'] 1157,32721437,"Budesonide Orodispersible Tablets Maintain Remission in a Randomized, Placebo-Controlled Trial of Patients With Eosinophilic Esophagitis.","BACKGROUND & AIMS Eosinophilic esophagitis (EoE) is a chronic inflammatory disorder. Swallowed topical-acting corticosteroids are effective in bringing active EoE into remission. However, it is not clear whether these drugs are effective for long-term maintenance of remission. METHODS We performed a double-blind trial to compare the efficacy and safety of 2 dosages of a budesonide orodispersible tablet (BOT) vs placebo in maintaining remission of EoE. Maintenance of remission was defined as absence of clinical and histologic relapse and no premature withdrawal for any reason. Two hundred and four adults with EoE in clinical and histologic remission, from 29 European study sites, were randomly assigned to groups given BOT 0.5 mg twice daily (n = 68), BOT 1.0 mg twice daily (n = 68), or placebo twice daily (n = 68) for up to 48 weeks. RESULTS At end of treatment, 73.5% of patients receiving BOT 0.5 mg twice daily and 75% receiving BOT 1.0 mg twice daily were in persistent remission compared with 4.4% of patients in the placebo group (P < .001 for both comparisons of BOT with placebo). Median time to relapse in the placebo group was 87 days. The frequency of adverse events was similar in the BOT and placebo groups. Morning serum levels of cortisol were in the normal range at baseline and did not significantly change during treatment. Four patients receiving BOT developed asymptomatic, low serum levels of cortisol. Clinically manifested candidiasis was suspected in 16.2% of patients in the BOT 0.5 mg group and in 11.8% of patients in the BOT 1.0 mg group; all infections resolved with treatment. CONCLUSIONS In a phase 3 trial, up to 48 weeks of treatment with BOT (0.5 mg or 1.0 mg twice daily) was superior to placebo in maintaining remission of EoE. Both dosages were equally effective and well tolerated. EudraCT number; 2014-001485-99; ClinicalTrials.gov number, NCT02434029.",2020,"Clinically manifested candidiasis was suspected in 16.2% of patients in the BOT 0.5 mg group and in 11.8% of patients in the BOT 1.0 mg group; all infections resolved with treatment. ","['Patients With Eosinophilic Esophagitis', 'Two hundred and four adults with EoE in clinical and histologic remission, from 29 European study sites']","['budesonide orodispersible tablet (BOT) vs placebo', 'Placebo', 'Budesonide Orodispersible Tablets', 'Swallowed topical-acting corticosteroids', 'BOT 0.5 mg twice daily (n=68), BOT 1.0 mg twice daily (n=68), or placebo', 'BOT', 'placebo']","['Median time to relapse', 'Morning serum levels of cortisol', 'asymptomatic, low serum levels of cortisol', 'frequency of adverse events', 'efficacy and safety', 'effective and well tolerated', 'Clinically manifested candidiasis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0341106', 'cui_str': 'Eosinophilic esophagitis'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C2960508', 'cui_str': 'Orodispersible tablet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0006840', 'cui_str': 'Candidiasis'}]",204.0,0.627341,"Clinically manifested candidiasis was suspected in 16.2% of patients in the BOT 0.5 mg group and in 11.8% of patients in the BOT 1.0 mg group; all infections resolved with treatment. ","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Straumann', 'Affiliation': 'Swiss Eosinophilic Esophagitis Research Group, Olten, Switzerland; Department of Gastroenterology and Hepatology, University Hospital Zurich, Zurich, Switzerland. Electronic address: alex.straumann@hin.ch.'}, {'ForeName': 'Alfredo J', 'Initials': 'AJ', 'LastName': 'Lucendo', 'Affiliation': 'Department of Gastroenterology, Hospital General de Tomelloso, Tomelloso, Spain; Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas, Madrid, Spain; Instituto de Investigación Sanitaria Princesa, Madrid, Spain.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Miehlke', 'Affiliation': 'Center for Digestive Diseases, Internal Medicine Center Eppendorf, Hamburg, Germany; Center for Esophageal Disorders, University Hospital Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Vieth', 'Affiliation': 'Institute for Pathology, Klinikum Bayreuth, Bayreuth, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Schlag', 'Affiliation': 'II. Medizinische Klinik, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Biedermann', 'Affiliation': 'Department of Gastroenterology and Hepatology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Cecilio Santander', 'Initials': 'CS', 'LastName': 'Vaquero', 'Affiliation': 'Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas, Madrid, Spain; Instituto de Investigación Sanitaria Princesa, Madrid, Spain; Servicio de Aparato Digestivo, Hospital Universitario de La Princesa, Madrid, Spain.'}, {'ForeName': 'Constanza', 'Initials': 'C', 'LastName': 'Ciriza de Los Rios', 'Affiliation': 'Department of Gastroenterology, Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Schmoecker', 'Affiliation': 'Department of Gastroenterology, Sana Klinikum Lichtenberg, Berlin, Germany.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Madisch', 'Affiliation': 'Department of Gastroenterology, Clinical-Center Region Hannover Clinic Siloah, Hannover, Germany.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Hruz', 'Affiliation': 'Department of Gastroenterology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Jamal', 'Initials': 'J', 'LastName': 'Hayat', 'Affiliation': ""Department of Gastroenterology, Saint George's University Hospitals National Health Service Trust, London, UK.""}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'von Arnim', 'Affiliation': 'Department of Gastroenterology, Hepatology and Infectious Diseases, University Hospital Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Albert Jan', 'Initials': 'AJ', 'LastName': 'Bredenoord', 'Affiliation': 'Department of Gastroenterology and Hepatology, Academic Medical Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schubert', 'Affiliation': 'Private Practice, Berlin, Germany.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Mueller', 'Affiliation': 'Department of Clinical Research and Development, Dr Falk Pharma GmbH, Freiburg, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Greinwald', 'Affiliation': 'Department of Clinical Research and Development, Dr Falk Pharma GmbH, Freiburg, Germany.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Schoepfer', 'Affiliation': 'Department of Gastroenterology and Hepatology, Centre Hospitalier Universitaire Vaudois, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Attwood', 'Affiliation': 'Department of Health Services Research, Durham University, Durham, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Gastroenterology,['10.1053/j.gastro.2020.07.039'] 1158,32728879,Effect of coffee and cocoa-based confectionery containing coffee on markers of cardiometabolic health: results from the pocket-4-life project.,"PURPOSE Coffee is an important source of bioactive compounds, including caffeine, trigonelline, and phenolic compounds. Several studies have highlighted the preventive effects of coffee consumption on major cardiometabolic (CM) diseases, but the impact of different coffee dosages on markers of CM risk in a real-life setting has not been fully understood. This study aimed to investigate the effect of coffee and cocoa-based confectionery containing coffee consumption on several CM risk factors in healthy subjects. METHODS In a three-arm, crossover, randomized trial, 21 volunteers were assigned to consume in a random order for 1 month: 1 cup of espresso coffee/day, 3 cups of espresso coffee/day, and 1 cup of espresso coffee plus 2 cocoa-based products containing coffee, twice per day. At the last day of each treatment, blood samples were collected and used for the analysis of inflammatory markers, trimethylamine N-oxide, nitric oxide, blood lipids, and markers of glucose/insulin metabolism. Moreover, anthropometric parameters and blood pressure were measured. Finally, food consumption during the interventions was monitored. RESULTS After 1 month, energy intake did not change among treatments, while significant differences were observed in the intake of saturated fatty acids, sugars, and total carbohydrates. No significant effect on CM markers was observed following neither the consumption of different coffee dosages nor after cocoa-based products containing coffee. CONCLUSIONS The daily consumption of common dosages of coffee and its substitution with cocoa-based products containing coffee showed no effect on CM risk factors in healthy subjects. TRIAL REGISTRATION NUMBER Registered at clinicaltrials.gov as NCT03166540, May 21, 2017.",2021,"No significant effect on CM markers was observed following neither the consumption of different coffee dosages nor after cocoa-based products containing coffee. ","['21 volunteers', 'healthy subjects']","['coffee and cocoa-based confectionery containing coffee', 'cup of espresso coffee/day, 3 cups of espresso coffee/day, and 1 cup of espresso coffee plus 2 cocoa-based products containing coffee', 'coffee and its substitution with cocoa-based products containing coffee', 'coffee and cocoa-based confectionery containing coffee consumption']","['anthropometric parameters and blood pressure', 'several CM risk factors', 'cardiometabolic health', 'intake of saturated fatty acids, sugars, and total carbohydrates', 'CM markers', 'CM risk factors', 'inflammatory markers, trimethylamine N-oxide, nitric oxide, blood lipids, and markers of glucose/insulin metabolism', 'energy intake']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006855', 'cui_str': 'Candy'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0360301', 'cui_str': 'Product base'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",21.0,0.109093,"No significant effect on CM markers was observed following neither the consumption of different coffee dosages nor after cocoa-based products containing coffee. ","[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Martini', 'Affiliation': 'Human Nutrition Unit, Department of Veterinary Sciences, University of Parma, University Hospital Building 27, Via Gramsci 14, 43126, Parma, Italy.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Rosi', 'Affiliation': 'Human Nutrition Unit, Department of Food and Drugs, University of Parma, 43125, Parma, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Tassotti', 'Affiliation': 'Human Nutrition Unit, Department of Food and Drugs, University of Parma, 43125, Parma, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Antonini', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, 43126, Parma, Italy.'}, {'ForeName': 'Margherita', 'Initials': 'M', 'LastName': ""Dall'Asta"", 'Affiliation': 'Human Nutrition Unit, Department of Food and Drugs, University of Parma, 43125, Parma, Italy.'}, {'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Bresciani', 'Affiliation': 'Human Nutrition Unit, Department of Veterinary Sciences, University of Parma, University Hospital Building 27, Via Gramsci 14, 43126, Parma, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Fantuzzi', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, 43126, Parma, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Spigoni', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, 43126, Parma, Italy.'}, {'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'Domínguez-Perles', 'Affiliation': 'Research Group on Quality, Safety and Bioactivity of Plant Foods, Department of Food Science and Technology, CEBAS-CSIC, University Campus of Espinardo, Edif. 25, 30100, Murcia, Spain.'}, {'ForeName': 'Donato', 'Initials': 'D', 'LastName': 'Angelino', 'Affiliation': 'Human Nutrition Unit, Department of Veterinary Sciences, University of Parma, University Hospital Building 27, Via Gramsci 14, 43126, Parma, Italy.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Ricci', 'Affiliation': 'Pediatric Epidemiology, Department of Pediatrics, Medical Faculty, Leipzig University, Leipzig, Germany.'}, {'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'Del Pozo-Luengo', 'Affiliation': 'Clinical Analysis Service, University Hospital Virgen de la Arrixaca, 30120, El Palmar, Murcia, Spain.'}, {'ForeName': 'Pedro Luis', 'Initials': 'PL', 'LastName': 'Tornel', 'Affiliation': 'Clinical Analysis Service, University Hospital Virgen de la Arrixaca, 30120, El Palmar, Murcia, Spain.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Scazzina', 'Affiliation': 'Human Nutrition Unit, Department of Food and Drugs, University of Parma, 43125, Parma, Italy.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Gil-Izquierdo', 'Affiliation': 'Research Group on Quality, Safety and Bioactivity of Plant Foods, Department of Food Science and Technology, CEBAS-CSIC, University Campus of Espinardo, Edif. 25, 30100, Murcia, Spain.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Dei Cas', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, 43126, Parma, Italy.'}, {'ForeName': 'Furio', 'Initials': 'F', 'LastName': 'Brighenti', 'Affiliation': 'Human Nutrition Unit, Department of Food and Drugs, University of Parma, 43125, Parma, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Bonadonna', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, 43126, Parma, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Del Rio', 'Affiliation': 'Human Nutrition Unit, Department of Veterinary Sciences, University of Parma, University Hospital Building 27, Via Gramsci 14, 43126, Parma, Italy. daniele.delrio@unipr.it.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Mena', 'Affiliation': 'Human Nutrition Unit, Department of Food and Drugs, University of Parma, 43125, Parma, Italy.'}]",European journal of nutrition,['10.1007/s00394-020-02347-5'] 1159,33230268,Intrinsic reward circuit connectivity profiles underlying symptom and quality of life outcomes following antidepressant medication: a report from the iSPOT-D trial.,"There is a critical need to better understand the neural basis of antidepressant medication (ADM) response with respect to both symptom alleviation and quality of life (QoL) in major depressive disorder (MDD). Reward neurocircuitry has been implicated in QoL, the neural basis of MDD, and the mechanisms of ADM response. Yet, we do not know whether change in reward neurocircuitry as a function of ADM is associated with change in symptoms and QoL. To address this gap in knowledge, we analyzed data from 128 patients with MDD who participated in the iSPOT-D trial and were assessed with functional neuroimaging pre- and post-ADM treatment (randomized to sertraline, venlafaxine-XR, or escitalopram). 58 matched healthy controls were scanned at the same time points. We quantified functional connectivity (FC) of reward neurocircuitry using nucleus accumbens (NAc) seed regions of interest, and then characterized how changes in FC relate to symptom response (primary outcome) and QoL response (secondary outcome). Symptom responders showed an increase in NAc-dorsal anterior cingulate cortex (ACC) FC relative to non-responders (p < 0.001) which was associated with improvement in physical QoL (p < 0.0003), and a decrease in NAc-inferior parietal lobule FC relative to controls (p < 0.001). QoL response was characterized by increases in FC between NAc-ventral ACC for environmental, NAc-thalamus for physical, and NAc-paracingulate gyrus for social domains (p < 0.001). Symptom responders to sertraline were distinguished by a decrease in NAc-insula FC (p < 0.001) and to venlafaxine-XR by an increase in NAc-inferior temporal gyrus FC (p < 0.005). Findings suggest that change in reward neurocircuitry may underlie differential ADM response profiles with respect to symptoms and QoL in depression.",2021,Symptom responders showed an increase in NAc-dorsal anterior cingulate cortex (ACC),"['128 patients with MDD who participated in the iSPOT-D trial and were assessed with functional neuroimaging pre- and post-ADM treatment (randomized to', '58 matched healthy controls']","['antidepressant medication', 'sertraline, venlafaxine-XR, or escitalopram']","['QoL response', 'NAc-inferior parietal lobule FC relative', 'NAc-insula FC', 'physical QoL', 'NAc-dorsal anterior cingulate cortex (ACC', 'NAc-inferior temporal gyrus FC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3178877', 'cui_str': 'Functional Neuroimaging'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C3469597', 'cui_str': 'Administration of medication'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0152304', 'cui_str': 'Inferior parietal lobule structure'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0175754', 'cui_str': 'Agenesis of corpus callosum'}, {'cui': 'C0152310', 'cui_str': 'Structure of middle temporal gyrus'}]",128.0,0.0573567,Symptom responders showed an increase in NAc-dorsal anterior cingulate cortex (ACC),"[{'ForeName': 'Adina S', 'Initials': 'AS', 'LastName': 'Fischer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA. adinaf@stanford.edu.'}, {'ForeName': 'Bailey', 'Initials': 'B', 'LastName': 'Holt-Gosselin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Scott L', 'Initials': 'SL', 'LastName': 'Fleming', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Hack', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Tali M', 'Initials': 'TM', 'LastName': 'Ball', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Alan F', 'Initials': 'AF', 'LastName': 'Schatzberg', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Williams', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA. leawilliams@stanford.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00905-3'] 1160,32755526,Septic Shock: A Genomewide Association Study and Polygenic Risk Score Analysis.,"Previous genetic association studies have failed to identify loci robustly associated with sepsis, and there have been no published genetic association studies or polygenic risk score analyses of patients with septic shock, despite evidence suggesting genetic factors may be involved. We systematically collected genotype and clinical outcome data in the context of a randomized controlled trial from patients with septic shock to enrich the presence of disease-associated genetic variants. We performed genomewide association studies of susceptibility and mortality in septic shock using 493 patients with septic shock and 2442 population controls, and polygenic risk score analysis to assess genetic overlap between septic shock risk/mortality with clinically relevant traits. One variant, rs9489328, located in AL589740.1 noncoding RNA, was significantly associated with septic shock (p = 1.05 × 10-10); however, it is likely a false-positive. We were unable to replicate variants previously reported to be associated (p < 1.00 × 10-6 in previous scans) with susceptibility to and mortality from sepsis. Polygenic risk scores for hematocrit and granulocyte count were negatively associated with 28-day mortality (p = 3.04 × 10-3; p = 2.29 × 10-3), and scores for C-reactive protein levels were positively associated with susceptibility to septic shock (p = 1.44 × 10-3). Results suggest that common variants of large effect do not influence septic shock susceptibility, mortality and resolution; however, genetic predispositions to clinically relevant traits are significantly associated with increased susceptibility and mortality in septic individuals.",2020,"Polygenic risk scores for hematocrit and granulocyte count were negatively associated with 28-day mortality (p = 3.04 × 10-3; p = 2.29 × 10-3), and scores for C-reactive protein levels were positively associated with susceptibility to septic shock (p = 1.44 × 10-3).","['patients with septic shock to enrich the presence of disease-associated genetic variants', 'Septic Shock', '493 patients with septic shock and 2442 population controls, and polygenic risk score analysis to assess genetic overlap between septic shock risk/mortality with clinically relevant traits']",[],"['septic shock', 'Polygenic risk scores for hematocrit and granulocyte count', 'susceptibility and mortality', '28-day mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0032662', 'cui_str': 'Population Control'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0185027', 'cui_str': 'Imbrication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",[],"[{'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0857490', 'cui_str': 'Granulocyte count'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.431108,"Polygenic risk scores for hematocrit and granulocyte count were negatively associated with 28-day mortality (p = 3.04 × 10-3; p = 2.29 × 10-3), and scores for C-reactive protein levels were positively associated with susceptibility to septic shock (p = 1.44 × 10-3).","[{'ForeName': 'Shannon', 'Initials': 'S', 'LastName': ""D'Urso"", 'Affiliation': 'The University of Queensland Diamantina Institute, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Dorrilyn', 'Initials': 'D', 'LastName': 'Rajbhandari', 'Affiliation': 'The George Institute for Global Health, Sydney, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Peach', 'Affiliation': 'The University of Queensland Diamantina Institute, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'de Guzman', 'Affiliation': 'Australian Translational Genomics Centre, Queensland University of Technology, Brisbane, Australia.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'The George Institute for Global Health, Sydney, Australia.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Medland', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Gordon', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Nicholas G', 'Initials': 'NG', 'LastName': 'Martin', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Symen', 'Initials': 'S', 'LastName': 'Ligthart', 'Affiliation': 'Department of Epidemiology, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Brown', 'Affiliation': ""Guy's & St Thomas' NHS Foundation Trust and King's College London NIHR Biomedical Research Centre, London, England.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Powell', 'Affiliation': 'Garvan-Weizmann Centre for Cellular Genomics, Garvan Institute, Sydney, Australia.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'McArthur', 'Affiliation': 'Department of Critical Care Medicine, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Rhodes', 'Affiliation': ""Department of Adult Critical Care, St George's University Hospitals NHS Foundation Trust and St George's University of London, London, UK.""}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Meyer', 'Affiliation': 'The George Institute for Global Health, Sydney, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Finfer', 'Affiliation': 'The George Institute for Global Health, Sydney, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Myburgh', 'Affiliation': 'The George Institute for Global Health, Sydney, Australia.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Blumenthal', 'Affiliation': 'The University of Queensland Diamantina Institute, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Cohen', 'Affiliation': ""Royal Brisbane and Women's Hospital, Brisbane, Australia.""}, {'ForeName': 'Balasubramanian', 'Initials': 'B', 'LastName': 'Venkatesh', 'Affiliation': 'The George Institute for Global Health, Sydney, Australia.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Cuellar-Partida', 'Affiliation': 'The University of Queensland Diamantina Institute, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Evans', 'Affiliation': 'The University of Queensland Diamantina Institute, University of Queensland, Brisbane, Australia.'}]",Twin research and human genetics : the official journal of the International Society for Twin Studies,['10.1017/thg.2020.60'] 1161,32755632,Training Community Therapists to Deliver an Individualized Mental Health Intervention for Autism Spectrum Disorder: Changes in Caregiver Outcomes and Mediating Role on Child Outcomes.,"OBJECTIVE This study examines the impact of training therapists to deliver ""An Individualized Mental Health Intervention for Autism Spectrum Disorder (ASD)"" (AIM HI) for children with autism spectrum disorder on caregiver outcomes and the mediating role of changes in caregiver outcomes on child outcomes. METHOD Data were drawn from a cluster randomized trial conducted in 29 publicly funded mental health programs randomized to receive AIM HI training or usual care. Therapists were recruited from enrolled programs and child/caregiver participants enrolled from therapists' caseloads. Participants included 202 caregivers of children 5 to 13 years of age with autism spectrum disorder. Caregiver strain and sense of competence were assessed at baseline and 6 month postbaseline. Child behaviors were assessed at baseline and 6, 12, and 18 months postbaseline. Therapist delivery of evidence-based intervention strategies were assessed between baseline and 6 months. RESULTS A significant training effect was observed for caregiver sense of competence, with AIM HI caregivers reporting significantly greater improvement relative to usual care. There was no significant training effect for caregiver strain. Observer-rated therapist delivery of evidence-based interventions strategies over 6 months mediated training effects for sense of competence at 6 months. Changes in sense of competence from baseline to 6 months was associated with reduced child challenging behaviors at 6 months and mediated child outcomes at 12 and 18 months. CONCLUSION Combined with research demonstrating effectiveness of therapist AIM HI training on child outcomes, this study provides further evidence of the positive impact of training community therapists in the AIM HI intervention. CLINICAL TRIAL REGISTRATION INFORMATION Effectiveness and Implementation of a Mental Health Intervention for ASD (AIM HI); https://clinicaltrials.gov/; NCT02416323.",2021,"Changes in sense of competence from baseline to 6 months was associated with reduced child challenging behaviors at 6 months and mediated child outcomes at 12 and 18 months. ","['children with autism spectrum disorder', 'Autism', 'Participants included 202 caregivers of children aged 5 to 13 with autism spectrum disorder', 'autism spectrum disorder (ASD', ""Therapists were recruited from enrolled programs and child/caregiver participants enrolled from therapists' caseloads"", 'Data were drawn from a cluster randomized trial conducted in 29 publicly-funded mental health programs']","['Mental Health Intervention', 'HI training or usual care', 'therapist AIM HI training', 'training therapists to deliver An Individualized Mental Health Intervention']","['Caregiver strain and sense of competence', 'Child behaviors', 'caregiver sense of competence']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0008065', 'cui_str': 'Behavior, Child'}]",202.0,0.180546,"Changes in sense of competence from baseline to 6 months was associated with reduced child challenging behaviors at 6 months and mediated child outcomes at 12 and 18 months. ","[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Brookman-Frazee', 'Affiliation': ""Child and Adolescent Services Research Center, San Diego, California; University of California, San Diego; Rady Children's Hospital, San Diego, California.""}, {'ForeName': 'Colby', 'Initials': 'C', 'LastName': 'Chlebowski', 'Affiliation': 'Child and Adolescent Services Research Center, San Diego, California; University of California, San Diego. Electronic address: cchlebowski@health.ucsd.edu.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Villodas', 'Affiliation': 'Child and Adolescent Services Research Center, San Diego, California; San Diego State University, California.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Roesch', 'Affiliation': 'San Diego State University, California.'}, {'ForeName': 'Kassandra', 'Initials': 'K', 'LastName': 'Martinez', 'Affiliation': 'Child and Adolescent Services Research Center, San Diego, California; University of California, San Diego; San Diego State University, California.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2020.07.896'] 1162,32767766,An Open-Label Study Evaluating the Pharmacokinetics and Safety of Diclofenac Potassium for Oral Solution for the Acute Treatment of MWA or MWoA in Pediatric Participants.,"OBJECTIVE To evaluate the pharmacokinetics, safety, and tolerability of a single 50-mg oral dose of diclofenac potassium for oral solution (OS) in a pediatric cohort with a diagnosis of episodic migraine; the 3-month safety trial following an outpatient dosing period was also evaluated. BACKGROUND Children and adolescents often experience migraine pain that is poorly controlled, which may affect their emotional and psychological well-being. Diclofenac potassium for OS is approved for the treatment of migraine with aura (MWA) or migraine without aura (MWoA) in adults 18 years of age or older. It is formulated in a soluble buffered powder that provides more rapid absorption than the tablet formulations of diclofenac potassium. In a randomized, double-blind, crossover trial, more adult patients were pain-free at 2 hours post-dose following treatment with diclofenac potassium for OS than those who received the diclofenac tablet formulation or placebo. METHODS This was a Phase 4 open-label study that took place at 2 US sites. Participants 12-17 years of age with a diagnosis of episodic MWA or MWoA for ≥3 months and ≤14 headaches per month were enrolled in the study. Participants received one 50-mg dose of diclofenac potassium for OS under fasted conditions on day 1. Blood samples were collected for PK analysis within 15 minutes pre-dose and at 5, 10, 15, 20, 30, 40, and 60 minutes post-dose, and at 2, 4, and 6 hours post-dose. Safety evaluations were performed after the initial dose and at the end of study on day 90; adverse events were monitored throughout the study. After completing the PK assessments, participants were given a 3-month supply (27 packets) of diclofenac potassium for OS (50-mg doses) for their migraine attacks. Participants were advised to take diclofenac potassium for OS at the onset of a migraine. They were told to take no more than 2 doses daily and not to use it more than 3 days/week. RESULTS Twenty-five participants completed the study; 84% were females and 96% were white or Caucasian, with a mean age of 15.5 years and a mean weight of 63.1 kg. Diclofenac was rapidly absorbed with a median time to maximum concentration of 15 minutes and a mean peak plasma concentration of 1412 (±846.2) ng/mL. Diclofenac had a half-life of 66.8 (±9.2) minutes. The mean area under the concentration-time curve from zero to the last measurable time point was 82,920.0 (±25,327.6) minutes × ng/mL, and the mean area under the concentration-time curve from time zero to infinity was 84,388.8 (±25,993.6) minutes × ng/mL. Participants took the study drug an average of 10 times over 79 days, with an overall total drug exposure of 506 mg. No deaths or discontinuations due to an AE were reported during the study. The most frequently reported treatment emergent adverse events were arthralgia and motion sickness, each of which occurred in 2 (8%) of the participants. CONCLUSIONS Diclofenac potassium for OS exhibited a favorable pharmacokinetic and safety profile in 12- to 17-year-old patients with a diagnosis of episodic MWA or MWoA.",2020,Diclofenac was rapidly absorbed with a median time to maximum concentration of 15 minutes and a mean peak plasma concentration of 1412 (±846.2),"['Twenty-five participants completed the study; 84% were females and 96% were white or Caucasian, with a mean age of 15.5\xa0years and a mean weight of 63.1\xa0kg', '12- to 17-year-old patients with a diagnosis of episodic MWA or MWoA', 'Pediatric Participants', 'migraine with aura (MWA) or migraine without aura (MWoA) in adults 18\xa0years of age or older', 'pediatric cohort with a diagnosis of episodic migraine', 'Participants 12-17\xa0years of age with a diagnosis of episodic MWA or MWoA for ≥3\xa0months and ≤14 headaches per month were enrolled in the study']","['diclofenac potassium', 'Diclofenac Potassium', 'diclofenac potassium for oral solution (OS', 'diclofenac potassium for OS', 'Diclofenac', 'diclofenac tablet formulation or placebo', 'Diclofenac potassium']","['pain-free', 'pharmacokinetic and safety profile', 'mean area under the concentration-time curve', 'adverse events', 'pharmacokinetics, safety, and tolerability']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0236018', 'cui_str': 'Aura'}, {'cui': 'C0338480', 'cui_str': 'Migraine without aura'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0154723', 'cui_str': 'Migraine with aura'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018681', 'cui_str': 'Headache'}]","[{'cui': 'C0282131', 'cui_str': 'Diclofenac potassium'}, {'cui': 'C0991536', 'cui_str': 'Oral solution'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",84.0,0.0704587,Diclofenac was rapidly absorbed with a median time to maximum concentration of 15 minutes and a mean peak plasma concentration of 1412 (±846.2),"[{'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'McVige', 'Affiliation': 'Headache Clinic, Dent Neurologic Institute, Amherst, NY, USA.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Hogan', 'Affiliation': 'Headache Clinic, Dent Neurologic Institute, Amherst, NY, USA.'}, {'ForeName': 'Clayton M', 'Initials': 'CM', 'LastName': 'Shanahan', 'Affiliation': 'Headache Clinic, Dent Neurologic Institute, Amherst, NY, USA.'}, {'ForeName': 'Diane L', 'Initials': 'DL', 'LastName': 'Amend', 'Affiliation': 'gRED Clinical Operations, Depomed, Inc, Newark, CA, USA.'}, {'ForeName': 'Shawn M', 'Initials': 'SM', 'LastName': 'Ferger', 'Affiliation': 'Department of Administration, Dent Neurologic Institute, Amherst, NY, USA.'}]",Headache,['10.1111/head.13922'] 1163,33200891,Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease.,"BACKGROUND The efficacy and safety of sodium-glucose cotransporter 2 inhibitors such as sotagliflozin in preventing cardiovascular events in patients with diabetes with chronic kidney disease with or without albuminuria have not been well studied. METHODS We conducted a multicenter, double-blind trial in which patients with type 2 diabetes mellitus (glycated hemoglobin level, ≥7%), chronic kidney disease (estimated glomerular filtration rate, 25 to 60 ml per minute per 1.73 m 2 of body-surface area), and risks for cardiovascular disease were randomly assigned in a 1:1 ratio to receive sotagliflozin or placebo. The primary end point was changed during the trial to the composite of the total number of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure. The trial ended early owing to loss of funding. RESULTS Of 19,188 patients screened, 10,584 were enrolled, with 5292 assigned to the sotagliflozin group and 5292 assigned to the placebo group, and followed for a median of 16 months. The rate of primary end-point events was 5.6 events per 100 patient-years in the sotagliflozin group and 7.5 events per 100 patient-years in the placebo group (hazard ratio, 0.74; 95% confidence interval [CI], 0.63 to 0.88; P<0.001). The rate of deaths from cardiovascular causes per 100 patient-years was 2.2 with sotagliflozin and 2.4 with placebo (hazard ratio, 0.90; 95% CI, 0.73 to 1.12; P = 0.35). For the original coprimary end point of the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, the hazard ratio was 0.84 (95% CI, 0.72 to 0.99); for the original coprimary end point of the first occurrence of death from cardiovascular causes or hospitalization for heart failure, the hazard ratio was 0.77 (95% CI, 0.66 to 0.91). Diarrhea, genital mycotic infections, volume depletion, and diabetic ketoacidosis were more common with sotagliflozin than with placebo. CONCLUSIONS In patients with diabetes and chronic kidney disease, with or without albuminuria, sotagliflozin resulted in a lower risk of the composite of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure than placebo but was associated with adverse events. (Funded by Sanofi and Lexicon Pharmaceuticals; SCORED ClinicalTrials.gov number, NCT03315143.).",2021,"The rate of deaths from cardiovascular causes per 100 patient-years was 2.2 with sotagliflozin and 2.4 with placebo (hazard ratio, 0.90; 95% CI, 0.73 to 1.12; P = 0.35).","['19,188 patients screened, 10,584 were enrolled, with 5292 assigned to the sotagliflozin group and 5292 assigned to the', 'patients with type 2 diabetes mellitus (glycated hemoglobin level, ≥7%), chronic kidney disease (estimated glomerular filtration rate, 25 to 60 ml per minute per 1.73 m 2 of body-surface area), and risks for cardiovascular disease', 'patients with diabetes and chronic kidney disease', 'Patients with Diabetes and Chronic Kidney Disease', 'patients with diabetes with chronic kidney disease with or without albuminuria have not been well studied']","['sotagliflozin or placebo', 'sodium-glucose cotransporter 2 inhibitors such as sotagliflozin', 'placebo', 'sotagliflozin', 'Sotagliflozin']","['composite of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure', 'rate of primary end-point events', 'death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, the hazard ratio', 'Diarrhea, genital mycotic infections, volume depletion, and diabetic ketoacidosis', 'total number of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure', 'rate of deaths from cardiovascular causes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C3502471', 'cui_str': '(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C3502471', 'cui_str': '(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0026946', 'cui_str': 'Mycosis'}, {'cui': 'C0546884', 'cui_str': 'Hypovolemia'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",10584.0,0.420389,"The rate of deaths from cardiovascular causes per 100 patient-years was 2.2 with sotagliflozin and 2.4 with placebo (hazard ratio, 0.90; 95% CI, 0.73 to 1.12; P = 0.35).","[{'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Szarek', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'Julia B', 'Initials': 'JB', 'LastName': 'Lewis', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Riddle', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'David Z I', 'Initials': 'DZI', 'LastName': 'Cherney', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'Jamie P', 'Initials': 'JP', 'LastName': 'Dwyer', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Scirica', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'Clifford J', 'Initials': 'CJ', 'LastName': 'Bailey', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Díaz', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'Kausik K', 'Initials': 'KK', 'LastName': 'Ray', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'Jacob A', 'Initials': 'JA', 'LastName': 'Udell', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Lapuerta', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2030186'] 1164,33200892,Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure.,"BACKGROUND Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of hospitalization for heart failure or death from cardiovascular causes among patients with stable heart failure. However, the safety and efficacy of SGLT2 inhibitors when initiated soon after an episode of decompensated heart failure are unknown. METHODS We performed a multicenter, double-blind trial in which patients with type 2 diabetes mellitus who were recently hospitalized for worsening heart failure were randomly assigned to receive sotagliflozin or placebo. The primary end point was the total number of deaths from cardiovascular causes and hospitalizations and urgent visits for heart failure (first and subsequent events). The trial ended early because of loss of funding from the sponsor. RESULTS A total of 1222 patients underwent randomization (608 to the sotagliflozin group and 614 to the placebo group) and were followed for a median of 9.0 months; the first dose of sotagliflozin or placebo was administered before discharge in 48.8% and a median of 2 days after discharge in 51.2%. Among these patients, 600 primary end-point events occurred (245 in the sotagliflozin group and 355 in the placebo group). The rate (the number of events per 100 patient-years) of primary end-point events was lower in the sotagliflozin group than in the placebo group (51.0 vs. 76.3; hazard ratio, 0.67; 95% confidence interval [CI], 0.52 to 0.85; P<0.001). The rate of death from cardiovascular causes was 10.6 in the sotagliflozin group and 12.5 in the placebo group (hazard ratio, 0.84; 95% CI, 0.58 to 1.22); the rate of death from any cause was 13.5 in the sotagliflozin group and 16.3 in the placebo group (hazard ratio, 0.82; 95% CI, 0.59 to 1.14). Diarrhea was more common with sotagliflozin than with placebo (6.1% vs. 3.4%), as was severe hypoglycemia (1.5% vs. 0.3%). The percentage of patients with hypotension was similar in the sotagliflozin group and the placebo group (6.0% and 4.6%, respectively), as was the percentage with acute kidney injury (4.1% and 4.4%, respectively). The benefits of sotagliflozin were consistent in the prespecified subgroups of patients stratified according to the timing of the first dose. CONCLUSIONS In patients with diabetes and recent worsening heart failure, sotagliflozin therapy, initiated before or shortly after discharge, resulted in a significantly lower total number of deaths from cardiovascular causes and hospitalizations and urgent visits for heart failure than placebo. (Funded by Sanofi and Lexicon Pharmaceuticals; SOLOIST-WHF ClinicalTrials.gov number, NCT03521934.).",2021,"Diarrhea was more common with sotagliflozin than with placebo (6.1% vs. 3.4%), as was severe hypoglycemia (1.5% vs. 0.3%).","['1222 patients underwent randomization (608 to the sotagliflozin group and 614 to the', 'patients with type 2 diabetes mellitus who were recently hospitalized for worsening heart failure', 'patients with stable heart failure', 'Patients with Diabetes and Recent Worsening Heart Failure']","['sotagliflozin or placebo', 'SGLT2 inhibitors', 'Sodium-glucose cotransporter 2 (SGLT2) inhibitors', 'placebo', 'sotagliflozin', 'Sotagliflozin']","['total number of deaths from cardiovascular causes and hospitalizations and urgent visits for heart failure (first and subsequent events', 'Diarrhea', 'percentage with acute kidney injury', 'percentage of patients with hypotension', 'safety and efficacy', 'severe hypoglycemia', 'total number of deaths from cardiovascular causes and hospitalizations and urgent visits for heart failure', 'rate of death from cardiovascular causes', 'rate of death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C3502471', 'cui_str': '(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C3502471', 'cui_str': '(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}]",1222.0,0.570115,"Diarrhea was more common with sotagliflozin than with placebo (6.1% vs. 3.4%), as was severe hypoglycemia (1.5% vs. 0.3%).","[{'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Szarek', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': 'Julia B', 'Initials': 'JB', 'LastName': 'Lewis', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Riddle', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Metra', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': 'Lars H', 'Initials': 'LH', 'LastName': 'Lund', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Komajda', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Testani', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Wilcox', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Lapuerta', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2030183'] 1165,32706731,Validation of a Mobile Version of the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form: An Observational Randomized Crossover Trial.,"BACKGROUND The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) questionnaire is an effective tool for evaluating shoulder joint function. The development and usage of a mobile version of the ASES questionnaire has the potential to save time, money, and effort. OBJECTIVE The aim of this study is to assess the equivalence between the paper and mobile versions of the ASES questionnaire and their acceptability among patients. METHODS The paper and mobile versions of the ASES questionnaire were used to evaluate the shoulder joint function of 50 patients with shoulder pain. This study included patients from the shoulder clinic of Sun Yat-sen Memorial Hospital. The intraclass correlation coefficient (ICC) and Bland-Altman method were used to evaluate the agreement (reliability) of the scores obtained by the two methods (paper versus mobile). RESULTS Of the 50 patients recruited from March 2018 to May 2019, 46 (92%) completed the study. There was a high agreement between the paper and mobile versions of the ASES questionnaire (ICC=0.979, 95% CI 0.943-0.987; P<.001). The mean difference between the scores of the mobile and paper versions was 1.0, and only 1/46 (2%) had a difference greater than the minimal clinically important difference of 12 points. About 75% of patients preferred the mobile version to the paper version. CONCLUSIONS Our study shows that the mobile version of the ASES questionnaire is comparable to the paper version, and has a higher patient preference. This could prove to be a useful tool for epidemiological studies and patient follow-up over longer periods of time.",2020,"There was a high agreement between the paper and mobile versions of the ASES questionnaire (ICC=0.979, 95% CI 0.943-0.987; P<.001).","['American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form', '50 patients recruited from March 2018 to May 2019, 46 (92%) completed the study', '50 patients with shoulder pain', 'patients', 'patients from the shoulder clinic of Sun Yat-sen Memorial Hospital']",['Elbow Surgeons Standardized Shoulder Assessment Form (ASES) questionnaire'],[],"[{'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036644', 'cui_str': 'Senegal'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",[],50.0,0.0611349,"There was a high agreement between the paper and mobile versions of the ASES questionnaire (ICC=0.979, 95% CI 0.943-0.987; P<.001).","[{'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': 'Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Qingyue', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Menglei', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Fangqi', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yiyong', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Long', 'Affiliation': 'Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yamuhanmode', 'Initials': 'Y', 'LastName': 'Alike', 'Affiliation': 'Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yuanhao', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Maslah Idiris', 'Initials': 'MI', 'LastName': 'Ali', 'Affiliation': 'Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Congda', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}]",JMIR mHealth and uHealth,['10.2196/16758'] 1166,32711957,Thermoregulatory responses to ice slurry ingestion during low and moderate intensity exercises with restrictive heat loss.,"OBJECTIVES We investigated the thermoregulatory responses to ice slurry ingestion during low- and moderate-intensity exercises with restrictive heat loss. DESIGN Randomised, counterbalanced, cross-over design. METHODS Following a familiarisation trial, ten physically active males exercised on a motorised treadmill at low-intensity (L; 40% VO 2max ) or moderate-intensity (M; 70% VO 2max ) for 75-min, in four randomised, counterbalanced trials. Throughout the exercise bout, participants donned a raincoat to restrict heat loss. Participants ingested 2gkg -1 body mass of ambient water (L+AMB and M+AMB trials) or ice slurry (L+ICE and M+ICE trials) at 15-min intervals during exercise in environmental conditions of T db, 25.1±0.6°C and RH, 63±5%. Heart rate (HR), gastrointestinal temperature (T gi ), mean weighted skin temperature (T sk ), estimated sweat loss, ratings of perceived exertion (RPE) and thermal sensation (RTS) were recorded. RESULTS Compared to L+AMB, participants completed L+ICE trials with lower ΔT gi (0.8±0.3°C vs 0.6±0.2°C; p=0.03), mean RPE (10±1 vs 9±1; p=0.03) and estimated sweat loss (0.91±0.2L vs 0.78±0.27L; p=0.04). Contrastingly, T gi (p=0.22), T sk (p=0.37), HR (p=0.31), RPE (p=0.38) and sweat loss (p=0.17) were similar between M+AMB and M+ICE trials. RTS was similar during both low-intensity (4.9±0.5 vs 4.7±0.3; p=0.10) and moderate-intensity exercise (5.3±0.47 vs 5.0±0.4; p=0.09). CONCLUSIONS Per-cooling using ice slurry ingestion marginally reduced thermal strain during low-intensity but not during moderate-intensity exercise. Ice slurry may be an effective and practical heat mitigation strategy during low-intensity exercise such as in occupational and military settings, but a greater volume should be considered to ensure its efficacy.",2021,"Ice slurry may be an effective and practical heat mitigation strategy during low-intensity exercise such as in occupational and military settings, but a greater volume should be considered to ensure its efficacy.","['Following a familiarisation trial, ten physically active males exercised on a']",['motorised treadmill at low-intensity (L; 40% VO 2max ) or moderate-intensity (M; 70% VO 2max '],"['mean RPE', 'estimated sweat loss', 'RTS', 'moderate-intensity exercise', 'thermal strain', 'Heart rate (HR), gastrointestinal temperature (T gi ), mean weighted skin temperature (T sk ), estimated sweat loss, ratings of perceived exertion (RPE) and thermal sensation (RTS', 'sweat loss', 'RPE']","[{'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0038984', 'cui_str': 'Sweat'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0039478', 'cui_str': 'Thermal sensation, function'}]",10.0,0.135853,"Ice slurry may be an effective and practical heat mitigation strategy during low-intensity exercise such as in occupational and military settings, but a greater volume should be considered to ensure its efficacy.","[{'ForeName': 'Sharifah B', 'Initials': 'SB', 'LastName': 'Alhadad', 'Affiliation': 'NUS Graduate School for Integrative Sciences and Engineering, National University of Singapore, Singapore; Department of Physiology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Saw Swee Hock School of Public Health, National University of Singapore, Singapore.'}, {'ForeName': 'Ivan C C', 'Initials': 'ICC', 'LastName': 'Low', 'Affiliation': 'Department of Physiology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Jason K W', 'Initials': 'JKW', 'LastName': 'Lee', 'Affiliation': 'Department of Physiology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Global Asia Institute, National University of Singapore, Singapore; N.1 Institute for Health, National University of Singapore, Singapore. Electronic address: phsjlkw@nus.edu.sg.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.07.002'] 1167,32720832,"A combination of three probiotic strains for treatment of acute diarrhoea in hospitalised children: an open label, randomised controlled trial.","Acute diarrhoea continues to be a leading cause of morbidity, hospitalisation, and mortality worldwide, and probiotics have been proposed as a complementary therapy in the treatment of acute diarrhoea. The goal of this study is to assess the efficacy and safety of three combined probiotic strains, Bifidobacterium lactis Bi-07, Lactobacillus rhamnosus HN001, and Lactobacillus acidophilus NCFM, as an adjunct to rehydration therapy in treatment of acute watery diarrhoea in hospitalised children. Eligible diarrheal children were randomised into intervention group (IG, n=96, conventional treatment for diarrhoea in combination with probiotics) and control group (CG, n=98, conventional treatment for diarrhoea without probiotics). The primary assessments of this study were duration of diarrhoea and hospital stay and improvement in diarrhoea symptoms. Significantly more children in the IG showed improvements in diarrhoea (defined as a decrease of stool frequency to no more than four times per day and an improved stool consistency within 24-48 h after the treatment) than those in the CG (96.9 vs 79.6%, P <0.05). Children supplemented with the mixed strains had a 22.5 h shorter (121.4±13.7 h vs 143.9±19.8 h) mean duration of diarrhoea and 1.2 d shorter hospital stays (5.1±1.2 d vs 6.3±1.4 d) than children only receiving the rehydration therapy ( P <0.05). The prevalence of constipation of children in the IG (3.1%) was markedly lower ( P <0.05) than that of children in the CG (13.3%) after treatment. In conclusion, the mixture of three probiotic strains given to children aged 1-3 years resulted in shorter durations of diarrhoea and hospitalisation and a higher percentage of improved children.",2020,"Significantly more children in the IG showed improvements in diarrhoea (defined as a decrease of stool frequency to no more than four times per day and an improved stool consistency within 24-48 h after the treatment) than those in the CG (96.9 vs 79.6%, P <0.05).","['hospitalised children', 'Eligible diarrheal children']","['probiotic strains', 'conventional treatment for diarrhoea in combination with probiotics) and control group (CG, n=98, conventional treatment for diarrhoea without probiotics']","['stool consistency', 'mean duration of diarrhoea', 'duration of diarrhoea and hospital stay and improvement in diarrhoea symptoms', 'diarrhoea', 'stool frequency', 'efficacy and safety', 'prevalence of constipation of children', 'shorter durations of diarrhoea and hospitalisation', 'hospital stays']","[{'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",,0.0416913,"Significantly more children in the IG showed improvements in diarrhoea (defined as a decrease of stool frequency to no more than four times per day and an improved stool consistency within 24-48 h after the treatment) than those in the CG (96.9 vs 79.6%, P <0.05).","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': ""Department of Nutrition, Chengdu Women's & Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, No. 1617, Riyue Avenue, Qingyang District, Chengdu, Sichuan 6100131, China P.R.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Xin', 'Affiliation': 'Infinitus (China) Company Ltd., Hangzhou, Zhejiang, China P.R.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': ""Department of Pediatric Intensive Care Unit, Chengdu Women's & Children's Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, Sichuan, China P.R.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Department of Pediatrics, Dayi Maternal and Child Health Care Hospital, Chengdu, Sichuan, China P.R.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Luo', 'Affiliation': 'Department of Pediatrics, Dayi Maternal and Child Health Care Hospital, Chengdu, Sichuan, China P.R.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Yuan', 'Affiliation': ""Department of Nutrition, Chengdu Women's & Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, No. 1617, Riyue Avenue, Qingyang District, Chengdu, Sichuan 6100131, China P.R.""}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Bu', 'Affiliation': 'Department of Pediatrics, Dayi Maternal and Child Health Care Hospital, Chengdu, Sichuan, China P.R.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Pediatrics, Dayi Maternal and Child Health Care Hospital, Chengdu, Sichuan, China P.R.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Ge', 'Affiliation': 'Infinitus (China) Company Ltd., Hangzhou, Zhejiang, China P.R.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, 5500 Campanile Dr, San Diego, CA 92182-7251, USA.'}]",Beneficial microbes,['10.3920/BM2020.0046'] 1168,32728881,Dietary macronutrients do not differently affect postprandial vascular endothelial function in apparently healthy overweight and slightly obese men.,"PURPOSE Well-designed trials comparing side-by-side effects of macronutrients on postprandial endothelial function are missing. Therefore, we investigated under well-controlled and isocaloric condition effects of fat, carbohydrates, and protein on postprandial endothelial function as assessed by brachial artery flow-mediated vasodilation (FMD), an important non-invasive technique to assess endothelial function. METHODS Eighteen apparently healthy overweight and slightly obese men (BMI 26.0-35.0 kg/m 2 ) completed this randomized, double-blinded, cross-over trial. The study consisted of three test days each separated by a wash-out period of at least 1 week. After an overnight fast, men received an isocaloric meal providing 3987 kJ (953 kcal) that was either high in dietary fat (En% fat [F]/carbohydrates [C]/protein [P]: 52.3, 39.2, 8.0), carbohydrates (En% F/C/P: 9.6, 81.5, 8.6), or protein (En% F/C/P: 10.6, 51.5, 36.9). Fasting and 2-h postprandial FMD responses were measured. RESULTS A postprandial decrease of 1.2% point in FMD was observed after the high-protein meal (P = 0.015). However, postprandial changes did not differ between meals (P = 0.45). An increase in baseline brachial artery diameters was observed after the high-protein meal (P < 0.001) and changes differed between meals (P = 0.020). A meal*time interaction was found for plasma glucose concentrations, with the most pronounced increases after the high-carbohydrate meal at T15, T30, T60, and T90 (P < 0.05). A significant time and meal (P < 0.001), but no time*meal effect (P = 0.06) was found for serum insulin concentrations. Increases in serum triacylglycerol concentrations did not differ between meals (P = 0.014). CONCLUSION Macronutrients did not differently affect postprandial endothelial function in apparently healthy overweight and slightly obese men. TRIAL REGISTRATION Trial registration number (ClinicalTrials.gov) NCT03139890 in May 2017.",2021,An increase in baseline brachial artery diameters was observed after the high-protein meal (P < 0.001) and changes differed between meals (P = 0.020).,"['apparently healthy overweight and slightly obese men', 'Eighteen apparently healthy overweight and slightly obese men (BMI 26.0-35.0\xa0kg/m 2 ']","['fat, carbohydrates, and protein', 'isocaloric meal']","['serum insulin concentrations', 'brachial artery flow-mediated vasodilation (FMD', 'serum triacylglycerol concentrations', 'baseline brachial artery diameters', 'FMD', 'plasma glucose concentrations', 'postprandial vascular endothelial function', 'postprandial changes', 'Fasting and 2-h postprandial FMD responses', 'postprandial endothelial function']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0750482', 'cui_str': 'Slightly'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}]",18.0,0.166585,An increase in baseline brachial artery diameters was observed after the high-protein meal (P < 0.001) and changes differed between meals (P = 0.020).,"[{'ForeName': 'Ellen T H C', 'Initials': 'ETHC', 'LastName': 'Smeets', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, PO Box 616, 6200 MD, Maastricht, The Netherlands.'}, {'ForeName': 'Ronald P', 'Initials': 'RP', 'LastName': 'Mensink', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, PO Box 616, 6200 MD, Maastricht, The Netherlands.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Joris', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, PO Box 616, 6200 MD, Maastricht, The Netherlands. p.joris@maastrichtuniversity.nl.'}]",European journal of nutrition,['10.1007/s00394-020-02340-y'] 1169,32767049,Radiomics derived from dynamic contrast-enhanced MRI pharmacokinetic protocol features: the value of precision diagnosis ovarian neoplasms.,"OBJECTIVES To evaluate the efficiency of 2- and 3-class classification predictive tasks constructed from radiomics features extracted from dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) pharmacokinetic (PK) protocol in discriminating among benign, borderline, and malignant ovarian tumors. METHODS One hundred and four ovarian lesions were evaluated using preoperative DCE-MRI. Radiomics features were extracted from 7 types of DCE-MR images. To explore the differential ability of radiomics between three types of ovarian tumors, two- and three-class classification tasks were established. The 2-class classification task was divided into three subtasks: benign vs. borderline (task A), benign vs. malignant (task B), and borderline vs. malignant (task C). For the 3-class classification task, 104 lesions were randomly divided into training (72 lesions) and validation (32 lesions) cohorts. The discrimination abilities of the radiomics signatures were established with the training cohort and tested with the independent validation cohort. The predictive performance of the task was evaluated by receiver operating characteristic (ROC) curve, calibration curve analysis, and decision curve analysis (DCA). RESULTS For the 2-class classification task, the combination of PK radiomics signatures model (PK model) showed a good diagnostic ability with the highest area under the ROC curves (AUCs) of 0.899, 0.865, and 0.893 for tasks A, B, and C, respectively. Additionally, the 3-class classification task demonstrated a good discrimination performance with AUCs of 0.893, 0.944, and 0.891 for the benign, borderline, and malignant groups, respectively. CONCLUSIONS Radiomics analysis based on the DCE-MRI PK protocol showed promise for discriminating among benign, borderline, and malignant ovarian tumors. KEY POINTS • Two-class classification predictive task of DCE-MRI PK protocol enabled the classification of 3 categories of ovarian tumors through the pairwise comparison strategy with a perfect diagnostic ability. • Three-class classification predictive task maintained good performance to effectively judge each category of ovarian tumors directly.",2021,"Additionally, the 3-class classification task demonstrated a good discrimination performance with AUCs of 0.893, 0.944, and 0.891 for the benign, borderline, and malignant groups, respectively. ","['104 lesions', 'One hundred and four ovarian lesions']","['DCE-MRI PK protocol', 'dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) pharmacokinetic (PK) protocol']","['receiver operating characteristic (ROC) curve, calibration curve analysis, and decision curve analysis (DCA']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]","[{'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0006751', 'cui_str': 'Calibration'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0037501', 'cui_str': 'Sodium Dichloroacetate'}]",104.0,0.0222798,"Additionally, the 3-class classification task demonstrated a good discrimination performance with AUCs of 0.893, 0.944, and 0.891 for the benign, borderline, and malignant groups, respectively. ","[{'ForeName': 'Xiao-Li', 'Initials': 'XL', 'LastName': 'Song', 'Affiliation': 'Radiology Department, Shanxi Medical University Second Affiliated Hospital, Taiyuan, 030001, Shanxi, China.'}, {'ForeName': 'Jia-Liang', 'Initials': 'JL', 'LastName': 'Ren', 'Affiliation': 'GE Healthcare, Beijing, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'Radiology Department, Shanxi Medical University Second Affiliated Hospital, Taiyuan, 030001, Shanxi, China.'}, {'ForeName': 'Lifang', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Radiology Department, Xi'an International Medical Center, Xi'an, Shanxi, China.""}, {'ForeName': 'Honghong', 'Initials': 'H', 'LastName': 'Ren', 'Affiliation': 'Radiology Department, Shanxi Medical University Second Affiliated Hospital, Taiyuan, 030001, Shanxi, China.'}, {'ForeName': 'Jinliang', 'Initials': 'J', 'LastName': 'Niu', 'Affiliation': 'Radiology Department, Shanxi Medical University Second Affiliated Hospital, Taiyuan, 030001, Shanxi, China. sxlscjy@163.com.'}]",European radiology,['10.1007/s00330-020-07112-0'] 1170,32779096,"IncobotulinumtoxinA for the Treatment of Blepharospasm in Toxin-Naïve Subjects: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial.","This study aimed to assess the efficacy/safety of incobotulinumtoxinA (Xeomin ® , Merz Pharmaceuticals GmbH) in botulinum neurotoxin-naïve subjects with blepharospasm. Botulinum neurotoxin-naïve subjects (≥ 12 months without botulinum neurotoxin treatment for blepharospasm) received single-dose incobotulinumtoxinA 50 U, 25 U, or placebo. Subjects were followed for 6-20 weeks (main period). Qualified subjects entered an open-label extension period and received another incobotulinumtoxinA injection (≤ 70 U). The primary efficacy variable was change from baseline in the Jankovic Rating Scale (JRS) severity subscore at the main period of week 6. Other efficacy variables included changes in the Blepharospasm Disability Index score and JRS frequency subscore and sumscore. Adverse events were monitored. Sixty-one subjects were randomized (main period: incobotulinumtoxinA 50 U, n = 19; incobotulinumtoxinA 25 U, n = 22; placebo, n = 20); 39 entered the open-label extension period (9, 14, and 16 subjects from the incobotulinumtoxinA 50 U, incobotulinumtoxinA 25 U, and placebo groups [main period], respectively, changed to open-label extension period dosing). A statistically significantly greater reduction in JRS severity subscore was reported for subjects receiving incobotulinumtoxinA 50 U versus placebo (ANCOVA, least square mean difference: - 1.2, p = 0.0004). Subjects receiving incobotulinumtoxinA experienced improvements in other efficacy variables versus baseline and/or placebo. Sustained clinical improvements and low adverse event rates (22.2-42.1%) were observed. This is the second placebo-controlled, double-blind study that demonstrates favorable efficacy/safety of incobotulinumtoxinA in subjects with blepharospasm. IncobotulinumtoxinA is the first botulinum neurotoxin that could fulfill the American Academy of Neurology criteria for a Level A recommendation for blepharospasm.Trial registration ClinicalTrials.gov identifier, NCT01896895.",2020,"A statistically significantly greater reduction in JRS severity subscore was reported for subjects receiving incobotulinumtoxinA 50 U versus placebo (ANCOVA, least square mean difference: - 1.2, p = 0.0004).","['botulinum neurotoxin-naïve subjects with blepharospasm', 'Sixty-one subjects were randomized (main period', 'subjects with blepharospasm']","['IncobotulinumtoxinA', 'Placebo', 'incobotulinumtoxinA 50 U, n\u2009=\u200919; incobotulinumtoxinA 25 U, n\u2009=\u200922; placebo, n\u2009=\u200920', 'Botulinum neurotoxin-naïve subjects (≥\u200912\xa0months without botulinum neurotoxin', 'incobotulinumtoxinA', 'incobotulinumtoxinA injection', 'single-dose incobotulinumtoxinA 50 U, 25\xa0U, or placebo', 'incobotulinumtoxinA 50 U, incobotulinumtoxinA 25 U, and placebo', 'placebo']","['low adverse event rates', 'Adverse events', 'Blepharospasm Disability Index score and JRS frequency subscore and sumscore', 'Jankovic Rating Scale (JRS) severity subscore', 'JRS severity subscore']","[{'cui': 'C1295507', 'cui_str': 'Bontoxilysin'}, {'cui': 'C0005747', 'cui_str': 'Blepharospasm'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C2930113', 'cui_str': 'IncobotulinumtoxinA'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1295507', 'cui_str': 'Bontoxilysin'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005747', 'cui_str': 'Blepharospasm'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",61.0,0.42825,"A statistically significantly greater reduction in JRS severity subscore was reported for subjects receiving incobotulinumtoxinA 50 U versus placebo (ANCOVA, least square mean difference: - 1.2, p = 0.0004).","[{'ForeName': 'Dimos D', 'Initials': 'DD', 'LastName': 'Mitsikostas', 'Affiliation': '1st Department of Neurology, National and Kapodistrian University of Athens, Athens, Greece. dimosmitsikostas@icloud.com.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Dekundy', 'Affiliation': 'Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.'}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Sternberg', 'Affiliation': 'Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Althaus', 'Affiliation': 'Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Pagan', 'Affiliation': 'Department of Neurology, Georgetown University Hospital Pasquerilla Healthcare Center, Washington, DC, USA.'}]",Advances in therapy,['10.1007/s12325-020-01427-6'] 1171,32713421,CPAP titration failure is not equivalent to long-term CPAP treatment failure in patients with obesity hypoventilation syndrome: a case series.,"STUDY OBJECTIVES Medium and long-term trials comparing continuous positive airway pressure (CPAP) with noninvasive ventilation in patients with obesity hypoventilation syndrome have shown no differences in outcomes. However, it remains unclear whether CPAP therapy should be prescribed if significant hypoxemia persists during CPAP titration, despite optimization of upper airway obstructive events or if maximum CPAP pressure is reached. We aimed to examine the effects of 6 weeks of home CPAP therapy on gas exchange in patients with obesity hypoventilation syndrome who failed CPAP titration due to persistent hypoxemia. METHODS This case series is a substudy of a randomized-controlled trial evaluating efficacy of 3 different PAP modalities in obesity hypoventilation syndrome. Patients randomized to CPAP who failed titration and were prescribed CPAP are included. CPAP failure was defined as spending more than 20% of total sleep time with oxygen saturation below 90% despite adequate resolution of apneas and hypopneas. Follow-up data included in-laboratory polysomnogram on prescribed CPAP after 6 weeks of home CPAP therapy. RESULTS Three of seven participants (43%) randomized to CPAP failed CPAP titration. All were morbidly obese, had severe OSA (apnea-hypopnea index > 90 events/h) and severe sleep hypoxemia (percentage of total sleep time with oxygen saturation < 90% [T90] = 60-89%). Hypoxemia (T90: 43-67%, T80: 0-31%, and T70: 0-11%) and hypercapnia (transcutaneous pressure of CO₂ levels > 50 mm Hg) persisted during CPAP titration polysomnogram. The final polysomnogram after 6 weeks of adherent home CPAP therapy showed effective control of obstructive sleep apnea. Hypoventilation and hypoxemia severity decreased significantly in all 3 participants. CONCLUSIONS Our data suggest that CPAP titration failure does not equal CPAP treatment failure. CLINICAL TRIAL REGISTRATION Registry: ClinicalTrials.gov; Name: AVAPS-AE Efficacy Study; URL: https://clinicaltrials.gov/ct2/show/NCT01368614; Identifier: NCT01368614.",2020,"Hypoventilation and hypoxemia severity decreased significantly in all three participants. ","['patients with OHS who failed CPAP titration due to persistent hypoxemia', 'All were morbidly obese, had severe OSA (AHI >90/h) and severe sleep hypoxemia (percentage of total sleep time with oxygen saturation <90% [T90] = 60-89', 'patients with obesity hypoventilation syndrome (OHS', 'patients with obesity hypoventilation syndrome']","['CPAP with noninvasive ventilation', 'CPAP', 'hypercapnia ', 'home CPAP therapy']","['CPAP failure', 'transcutaneous pCO₂ levels ', 'Hypoventilation and hypoxemia severity', 'Hypoxemia', 'effective control of OSA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031880', 'cui_str': 'Extreme obesity with alveolar hypoventilation'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0439087', 'cui_str': '<90'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3203358', 'cui_str': 'Hypoventilation'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]",7.0,0.113595,"Hypoventilation and hypoxemia severity decreased significantly in all three participants. ","[{'ForeName': 'Alejandra C', 'Initials': 'AC', 'LastName': 'Lastra', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Masa', 'Affiliation': 'Respiratory Department, San Pedro de Alcántara Hospital, Cáceres, Spain.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Mokhlesi', 'Affiliation': 'Section of Pulmonary and Critical Care, Department of Medicine, University of Chicago, Chicago, Illinois.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8712'] 1172,32720628,Cost-effectiveness of WHO Problem Management Plus for adults with mood and anxiety disorders in a post-conflict area of Pakistan: randomised controlled trial.,"BACKGROUND With the development of evidence-based interventions for treatment of priority mental health conditions in humanitarian settings, it is important to establish the cost-effectiveness of such interventions to enable their scale-up. AIMS To evaluate the cost-effectiveness of the Problem Management Plus (PM+) intervention compared with enhanced usual care (EUC) for common mental disorders in primary healthcare in Peshawar, Pakistan. Trial registration ACTRN12614001235695 (anzctr.org.au). METHOD We randomly allocated 346 participants to either PM+ (n = 172) or EUC (n = 174). Effectiveness was measured using the Hospital Anxiety and Depression Scale (HADS) at 3 months post-intervention. Cost-effectiveness analysis was performed as incremental costs (measured in Pakistani rupees, PKR) per unit change in anxiety, depression and functioning scores. RESULTS The total cost of delivering PM+ per participant was estimated at PKR 16 967 (US$163.14) using an international trainer and supervisor, and PKR 3645 (US$35.04) employing a local trainer. The mean cost per unit score improvement in anxiety and depression symptoms on the HADS was PKR 2957 (95% CI 2262-4029) (US$28) with an international trainer/supervisor and PKR 588 (95% CI 434-820) (US$6) with a local trainer/supervisor. The mean incremental cost-effectiveness ratio (ICER) to successfully treat a case of depression (PHQ-9 ≥ 10) using an international supervisor was PKR 53 770 (95% CI 39 394-77 399) (US$517), compared with PKR 10 705 (95% CI 7731-15 627) (US$102.93) using a local supervisor. CONCLUSIONS The PM+ intervention was more effective but also more costly than EUC in reducing symptoms of anxiety, depression and improving functioning in adults impaired by psychological distress in a post-conflict setting of Pakistan.",2020,"The PM+ intervention was more effective but also more costly than EUC in reducing symptoms of anxiety, depression and improving functioning in adults impaired by psychological distress in a post-conflict setting of Pakistan.","['53', 'common mental disorders in primary healthcare in Peshawar, Pakistan', 'adults with mood and anxiety disorders in a post-conflict area of Pakistan', '346 participants to either']","['WHO Problem Management', 'PM+ intervention', 'enhanced usual care (EUC', 'Problem Management Plus (PM+) intervention', 'PM', 'EUC', 'international supervisor was PKR']","['mean cost per unit score improvement in anxiety and depression symptoms', 'mean incremental cost-effectiveness ratio (ICER', 'incremental costs (measured in Pakistani rupees, PKR) per unit change in anxiety, depression and functioning scores', 'symptoms of anxiety, depression and improving functioning', 'Hospital Anxiety and Depression Scale (HADS', 'cost-effectiveness', 'total cost of delivering PM']","[{'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0403172', 'cui_str': 'Supervisor'}, {'cui': 'C0058980', 'cui_str': 'Hemin-Controlled Translational Repressor'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0240620', 'cui_str': 'Pakistani'}, {'cui': 'C0058980', 'cui_str': 'Hemin-Controlled Translational Repressor'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",346.0,0.173334,"The PM+ intervention was more effective but also more costly than EUC in reducing symptoms of anxiety, depression and improving functioning in adults impaired by psychological distress in a post-conflict setting of Pakistan.","[{'ForeName': 'Syed Usman', 'Initials': 'SU', 'LastName': 'Hamdani', 'Affiliation': 'Institute of Life and Human Sciences, University of Liverpool, UK; and Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Zill-E-', 'Initials': 'ZE', 'LastName': 'Huma', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'Institute of Life and Human Sciences, University of Liverpool, UK.'}, {'ForeName': 'Duolao', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Liverpool School of Tropical Medicine, UK.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Liverpool School of Tropical Medicine, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'van Ommeren', 'Affiliation': 'Department of Mental Health and Substance Abuse, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Chisholm', 'Affiliation': 'WHO Regional Office for Europe, Copenhagen, Denmark.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Farooq', 'Affiliation': 'Lady Reading Hospital, Peshawar, Pakistan; and School of Primary, Community and Social Care, Keele University, UK.'}]",The British journal of psychiatry : the journal of mental science,['10.1192/bjp.2020.138'] 1173,32723679,Bevacizumab plus fosbretabulin in recurrent ovarian cancer: Overall survival and exploratory analyses of a randomized phase II NRG oncology/gynecologic oncology group study.,"OBJECTIVE To explore the relationship between tumor size and response to combined anti-vascular targeted therapy using the anti-angiogenesis inhibitor, bevacizumab, and the tubulin-binding vascular disrupting agent, fosbretabulin. METHODS An exploratory, post-hoc analysis of the randomized phase II trial, Gynecologic Oncology Group-0186I, was performed. One hundred and seven patients with recurrent ovarian carcinoma, treated with up to 3 prior regimens, were randomized to bevacizumab 15 mg/kg body weight with or without intravenous fosbretabulin 60 mg/m 2 body surface area every 21 days until progression or unacceptable toxicity. The primary analysis favored the combination (HR 0.69; 95% CI, 0.47-1.00; p = .049) [Monk BJ, et al. J Clin Oncol 2016;34:2279-86]. The Cox proportional hazards model was used to estimate the treatment effect in various subpopulations. RESULTS With extended follow-up, the median PFS for bevacizumab plus fosbretabulin was 7.6  months as compared to 4.8  months with bevacizumab alone (HR 0.74; 90% CI, 0.54-1.02). Overall survival was similar in the experimental and control arms (25.2 vs 24.4 mos, respectively, HR 0.85; 90% CI, 0.59-1.22; p = .461). Eighty-one patients had measurable disease and median tumor size was 5.7  cm. In the ≤5.7  cm subgroup, the HR for progression or death was 0.77 (90% CI 0.45-1.31). Patients with tumors >5.7  cm (n = 40) had a HR for progression or death of 0.55; 90% CI, 0.32-0.96; p = .075). CONCLUSIONS Although no significant survival benefit was observed, the trend showing a reduced HR for progression or death with increasing tumor size when fosbretabulin is added to bevacizumab compared to bevacizumab alone warrants further study.",2020,"RESULTS With extended follow-up","['recurrent ovarian cancer', 'One hundred and seven patients with recurrent ovarian carcinoma']","['bevacizumab 15\u202fmg/kg body weight with or without intravenous fosbretabulin 60\u202fmg/m 2 body surface area', 'combined anti-vascular targeted therapy using the anti-angiogenesis inhibitor, bevacizumab', 'bevacizumab', 'Bevacizumab plus fosbretabulin']","['survival benefit', 'Overall survival', 'measurable disease and median tumor size', 'HR for progression or death', 'median PFS for bevacizumab plus fosbretabulin']","[{'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0560741', 'cui_str': 'mg/kg body weight'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0056154', 'cui_str': 'fosbretabulin'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0596087', 'cui_str': 'Angiogenesis inhibitor'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0056154', 'cui_str': 'fosbretabulin'}]",107.0,0.0982756,"RESULTS With extended follow-up","[{'ForeName': 'Krishnansu S', 'Initials': 'KS', 'LastName': 'Tewari', 'Affiliation': 'University of California, Irvine, Division of Gynecologic Oncology, Orange, CA, United States. Electronic address: ktewari@uci.edu.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Sill', 'Affiliation': 'NRG Oncology, Clinical Trial Development Division, Biostatistics & Bioinformatics, Roswell Park, Buffalo, NY 14263, United States. Electronic address: sillm@nrgoncology.org.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Aghajanian', 'Affiliation': 'Memorial Sloan-Kettering Cancer Center, New York, NY, United States. Electronic address: aghajanc@MSKCC.org.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Mannel', 'Affiliation': 'The Peggy and Charles Stephenson Cancer Center, The University of Oklahoma Health Sciences Center, 800 NE 10(th) St., SOCC 6043, Oklahoma City, OK 73104, United States. Electronic address: robert-mannel@ouhsc.edu.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'DiSilvestro', 'Affiliation': 'Women and Infants Hospital of Rhode Island, 101 Dudley St., Providence, RI 02905, United States. Electronic address: PDiSilvestro@WIHRI.org.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Powell', 'Affiliation': 'Washington University School of Medicine, 4911 Barnes Jewish Hospital Plaza, St. Louis, MO 63110, United States. Electronic address: mpowell@wustl.edu.'}, {'ForeName': 'Leslie M', 'Initials': 'LM', 'LastName': 'Randall', 'Affiliation': 'University of California, Irvine, Division of Gynecologic Oncology, Orange, CA, United States. Electronic address: Leslie.Randall@vcuhealth.org.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Farley', 'Affiliation': ""Creighton University School of Medicine at St. Joseph's Hospital and Medical Center, Pheonix, AZ 85013, United States. Electronic address: John.farley@chw.edu.""}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Rubin', 'Affiliation': 'Fox Chase Cancer Center, 333 Cottman Ave., Philadelphia, PA 19111, United States. Electronic address: stephen.rubin@fccc.edu.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Monk', 'Affiliation': ""Arizona Oncology (US Oncology Network), University of Arizona College of Medicine-Phoenix, Creighton University School of Medicine, St. Joseph's Hospital, Phoenix, AZ, United States. Electronic address: Bradley.Monk@usoncology.com.""}]",Gynecologic oncology,['10.1016/j.ygyno.2020.07.015'] 1174,32729619,Comparing two measures of sleep depth/intensity.,"STUDY OBJECTIVES To compare delta spectral power (delta) and odds ratio product (ORP) as measures of sleep depth during sleep restriction with placebo or a drug that increases delta. METHODS This is a secondary analysis of data from a study of 41 healthy participants randomized to receive placebo or gaboxadol 15 mg during sleep restriction. Participants underwent in-laboratory sleep studies on two baseline, four sleep restriction (5-h), and two recovery nights. Relation between delta or ORP and sleep depth was operationally defined as the degree of association of each metric to the probability of arousal or awakening occurring during the next 30 s (arousability). RESULTS ORP values in wake, N1, N2, N3, and REM were significantly different. Delta differed between both N2 and N3 and other sleep stages but not between wake and N1 or N1 and REM. Epoch-by-epoch and individual correlations between ORP and delta power were modest or insignificant. The relation between ORP and arousability was linear across the entire ORP range. Delta also changed with arousability but only when delta values were less than 300 μV2. Receiver-operating-characteristic analysis found the ability to predict imminent arousal to be significantly greater with ORP than with log delta power for all experimental conditions. Changes in ORP, but not log delta, across the night correlated with next-day physiologic sleep tendency. CONCLUSIONS Compared to delta power, ORP is more discriminating among sleep stages, more sensitive to sleep restriction, and more closely associated with arousability. This evidence supports ORP as a measure of sleep depth/intensity.",2020,Delta differed between both N2 and N3 and other sleep stages but not between wake and N1 or N1 and REM.,"['Participants underwent in-laboratory sleep studies on two baseline, four sleep restriction (5-h), and two recovery nights', '41 healthy participants']","['placebo or gaboxadol', 'placebo']","['delta spectral power (delta) and odds ratio product (ORP', 'ORP values in wake, N1, N2, N3, and REM', 'delta or ORP and sleep depth', 'sleep depth/intensity', 'Changes in ORP']","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0047845', 'cui_str': 'gaboxadol'}]","[{'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0560134', 'cui_str': 'rem'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",41.0,0.0283715,Delta differed between both N2 and N3 and other sleep stages but not between wake and N1 or N1 and REM.,"[{'ForeName': 'Magdy', 'Initials': 'M', 'LastName': 'Younes', 'Affiliation': 'Sleep Disorders Centre, Misericordia Health Centre, University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Paula K', 'Initials': 'PK', 'LastName': 'Schweitzer', 'Affiliation': ""Sleep Medicine & Research Center, St. Luke's Hospital, Chesterfield, MO.""}, {'ForeName': 'Kara S', 'Initials': 'KS', 'LastName': 'Griffin', 'Affiliation': ""Sleep Medicine & Research Center, St. Luke's Hospital, Chesterfield, MO.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Balshaw', 'Affiliation': 'Centre for Healthcare Innovation, Rady Faculty of Health Science, University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Walsh', 'Affiliation': ""Sleep Medicine & Research Center, St. Luke's Hospital, Chesterfield, MO.""}]",Sleep,['10.1093/sleep/zsaa127'] 1175,32729631,Evaluation of the efficacy of pimavanserin in the treatment of agitation and aggression in patients with Alzheimer's disease psychosis: A post hoc analysis.,"OBJECTIVES Patients with Alzheimer's disease psychosis (ADP) commonly experience concomitant agitation and aggression. We investigated whether a reduction in ADP following pimavanserin treatment conferred a reduction in associated agitation and aggression. METHODS ACP-103-019 was a 12-week, randomized, double-blind, placebo-controlled study that evaluated the efficacy of pimavanserin (34 mg) in reducing psychotic symptoms in patients with ADP. The primary endpoint was change from baseline in Neuropsychiatric Inventory-Nursing Home Version-Psychosis Score (NPI-NH-PS) at week six. A post hoc analysis examined whether there was a greater reduction in agitation and aggression (NPI-NH domain C [agitation/aggression] and Cohen-Mansfield Agitation Inventory-Short Form [CMAI-SF]) in pimavanserin-treated patients who experienced a reduction of hallucinations and delusions (psychosis responders defined as ≥50% reduction from baseline in NPI-NH-PS, week six) when compared with those who did not (nonresponders). RESULTS Pimavanserin-treated patients with ≥50% response in psychotic symptoms (n = 44) showed a greater improvement in agitation and aggression symptoms on the NPI-NH domain C (week six, least squares mean [LSM] difference = -3.64, t = -4.69, P < .0001) and the CMAI-SF (week six, LSM difference = -3.71, t = -2.01, P = .0483) than nonresponders (n = 32). Differences between psychosis responders and nonresponders were also observed in patients with more severe agitation and aggression at baseline on the NPI-NH domain C (responders, n = 26; nonresponders, n = 13; week six, LSM difference = -3.03, t = -2.44, P = .019). CONCLUSIONS Patients with ADP, who show improvement in psychotic symptoms after pimavanserin treatment, also experience an improvement in concomitant agitation and aggression.",2020,"Differences between psychosis responders and nonresponders were also observed in patients with more severe agitation and aggression at baseline on the NPI-NH domain C (responders, n = 26; nonresponders, n = 13; week six, LSM difference = ","[""patients with Alzheimer's disease psychosis"", 'patients with ADP', ""Patients with Alzheimer's disease psychosis (ADP) commonly experience concomitant agitation and aggression""]","['pimavanserin', 'placebo']","['agitation and aggression', 'severe agitation and aggression', 'concomitant agitation and aggression', 'psychotic symptoms', 'CMAI-SF', 'agitation and aggression (NPI-NH domain C [agitation/aggression] and Cohen-Mansfield Agitation Inventory-Short Form [CMAI-SF', 'agitation and aggression symptoms', 'Neuropsychiatric Inventory-Nursing Home Version-Psychosis Score (NPI-NH-PS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}]","[{'cui': 'C1722267', 'cui_str': 'pimavanserin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.405078,"Differences between psychosis responders and nonresponders were also observed in patients with more severe agitation and aggression at baseline on the NPI-NH domain C (responders, n = 26; nonresponders, n = 13; week six, LSM difference = ","[{'ForeName': 'Clive G', 'Initials': 'CG', 'LastName': 'Ballard', 'Affiliation': 'University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Coate', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, California, USA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Abler', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, California, USA.'}, {'ForeName': 'Srdjan', 'Initials': 'S', 'LastName': 'Stankovic', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, California, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Foff', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, California, USA.'}]",International journal of geriatric psychiatry,['10.1002/gps.5381'] 1176,32726475,Effectiveness of Advance Care Planning Group Visits Among Older Adults in Primary Care.,"BACKGROUND Group visits can support health behavior change and self-efficacy. In primary care, an advance care planning (ACP) group visit may leverage group dynamics and peer mentorship to facilitate education and personal goal setting that result in ACP engagement. OBJECTIVE To determine whether the ENgaging in Advance Care Planning Talks (ENACT) group visits intervention improves ACP documentation and readiness in older adults. METHODS This randomized clinical trial was conducted among geriatric primary care patients from the University of Colorado Hospital Seniors Clinic, Aurora, CO, from August 2017 to November 2019. Participants randomized to ENACT group visits (n = 55) participated in two 2-hour sessions with discussions of ACP topics and use of ACP tools (i.e., Conversation Starter Kit, Medical Durable Power of Attorney form, and PREPARE videos). Participants randomized to the control arm (n = 55) received the Conversation Starter Kit and a Medical Durable Power of Attorney form by mail. The primary outcomes included presence of ACP documents or medical decision-maker documentation in the electronic health record (EHR) at 6 months, and a secondary outcome was ACP readiness (validated four-item ACP Engagement Survey) at 6 months. RESULTS Participants were a mean of 77 years old, 60% female, and 79% white. At 6 months, 71% of ENACT participants had an advance directive in the EHR (26% higher) compared with 45% of control arm participants (P < .001). Similarly, 93% of ENACT participants had decision-maker documentation in the EHR (29% higher) compared with 73% in the control arm (P < .001). ENACT participants trended toward higher readiness to engage in ACP compared with control (4.56 vs 4.13; P = .16) at 6 months. CONCLUSION An ACP group visit increased ACP documentation and readiness to engage in ACP behavior change. Primary care teams can explore implementation and adaptation of ACP group visits into routine care, as well as longer-term impact on patient health outcomes. J Am Geriatr Soc 68:2382-2389, 2020.",2020,"ENACT participants trended toward higher readiness to engage in ACP compared with control (4.56 vs 4.13; P = .16) at 6 months. ","['geriatric primary care patients from the University of Colorado Hospital Seniors Clinic, Aurora, CO, from August 2017 to November 2019', 'Participants were a mean of 77\u2009years old, 60% female, and 79% white', 'older adults', 'Older Adults in Primary Care']","['discussions of ACP topics and use of ACP tools (i.e., Conversation Starter Kit, Medical Durable Power of Attorney form, and PREPARE videos', 'Conversation Starter Kit and a Medical Durable Power of Attorney form by mail', 'ENgaging in Advance Care Planning Talks (ENACT) group visits intervention', 'ACP', 'Advance Care Planning Group Visits', 'advance care planning (ACP) group visit may leverage group dynamics and peer mentorship to facilitate education and personal goal setting that result in ACP engagement', 'ENACT']","['readiness to engage in ACP', 'presence of ACP documents or medical decision-maker documentation in the electronic health record (EHR', 'decision-maker documentation', 'ACP documentation and readiness', 'ACP documentation and readiness to engage in ACP behavior change', 'advance directive in the EHR']","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0586806', 'cui_str': 'Power of attorney observable'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0025370', 'cui_str': 'Mentorships'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}]","[{'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0554244', 'cui_str': 'Maker'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}]",,0.0679267,"ENACT participants trended toward higher readiness to engage in ACP compared with control (4.56 vs 4.13; P = .16) at 6 months. ","[{'ForeName': 'Hillary D', 'Initials': 'HD', 'LastName': 'Lum', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Dukes', 'Affiliation': 'University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Andrea E', 'Initials': 'AE', 'LastName': 'Daddato', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Juarez-Colunga', 'Affiliation': 'Division of Biostatistics and Informatics, Colorado School of Public Health, Aurora, Colorado, USA.'}, {'ForeName': 'Prajakta', 'Initials': 'P', 'LastName': 'Shanbhag', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'Jean S', 'Initials': 'JS', 'LastName': 'Kutner', 'Affiliation': 'Division of General Internal Medicine , Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'Cari R', 'Initials': 'CR', 'LastName': 'Levy', 'Affiliation': 'Denver-Seattle Center of Innovation for Veteran-Centered and Value Driven Care, Eastern Colorado Health Care System, Aurora, Colorado, USA.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Sudore', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of California, San Francisco, San Francisco, California, USA.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16694'] 1177,32733445,Topical Tenofovir Pre-exposure Prophylaxis and Mucosal HIV-Specific Fc-Mediated Antibody Activities in Women.,"The RV144 HIV-vaccine trial highlighted the importance of envelope-specific non-neutralizing antibody (nNAb) Fc-mediated functions as immune correlates of reduced risk of infection. Since pre-exposure prophylaxis (PrEP) and HIV-vaccines are being used as a combination prevention strategy in at risk populations, the effects of PrEP on nNAb functions both mucosally and systemically remain undefined. Previous animal and human studies demonstrated reduced HIV-specific antibody binding avidity post-HIV seroconversion with PrEP, which in turn may affect antibody functionality. In seroconverters from the CAPRISA 004 tenofovir gel trial, we previously reported significantly higher detection and titres of HIV-specific binding antibodies in the plasma and genital tract (GT) that distinguished the tenofovir from the placebo arm. We hypothesized that higher HIV-specific antibody titres and detection reflected corresponding increased antibody-dependent neutrophil-mediated phagocytosis (ADNP) and NK-cell-activated antibody-dependent cellular cytotoxic (ADCC) activities. HIV-specific V1V2-gp70, gp120, gp41, p66, and p24 antibodies in GT and plasma samples of 48 seroconverters from the CAPRISA 004 tenofovir gel trial were tested for ADCP and ADCC at 3, 6- and 12-months post-HIV-infection. GT gp41- and p24-specific ADNP were significantly higher in the tenofovir than the placebo arm at 6 and 12 months respectively ( p < 0.05). Plasma gp120-, gp41-, and p66-specific ADNP, and GT gp41-specific ADCC increased significantly over time ( p < 0.05) in the tenofovir arm. In the tenofovir arm only, significant inverse correlations were observed between gp120-specific ADCC and gp120-antibody titres ( r = -0.54; p = 0.009), and gp41-specific ADNP and gp41-specific antibody titres at 6 months post-infection ( r = -0.50; p = 0.015). In addition, in the tenofovir arm, gp41-specific ADCC showed significant direct correlations between the compartments ( r = 0.53; p = 0.045). Certain HIV-specific nNAb activities not only dominate specific immunological compartments but can also exhibit diverse functions within the same compartment. Our previous findings of increased HIV specific antibody detection and titres in women who used tenofovir gel, and the limited differences in nNAb activities between the arms, suggest that prior PrEP did not modulate these nNAb functions post-HIV seroconversion. Together these data provide insight into envelope-specific-nNAb Fc-mediated functions at the site of exposure which may inform on ensuing immunity during combination HIV prevention strategies including PrEP and HIV vaccines.",2020,GT gp41- and p24-specific ADNP were significantly higher in the tenofovir than the placebo arm at 6 and 12 months respectively ( p < 0.05).,['Women'],"['Topical Tenofovir Pre-exposure Prophylaxis and Mucosal HIV-Specific', 'tenofovir', 'placebo']","['higher HIV-specific antibody titres and detection reflected corresponding increased antibody-dependent neutrophil-mediated phagocytosis (ADNP) and NK-cell-activated antibody-dependent cellular cytotoxic (ADCC) activities', 'gp41-specific ADNP and gp41-specific antibody titres', 'Plasma gp120-, gp41-, and p66-specific ADNP, and GT gp41-specific ADCC', 'Fc-Mediated Antibody Activities', 'detection and titres of HIV-specific binding antibodies in the plasma and genital tract (GT', 'gp120-specific ADCC and gp120-antibody titres', 'GT gp41- and p24-specific ADNP']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0031308', 'cui_str': 'Phagocytosis'}, {'cui': 'C0022688', 'cui_str': 'NK-cell'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0304497', 'cui_str': 'Cytotoxic agent'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0019692', 'cui_str': 'Envelope Protein gp41, HIV'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0019691', 'cui_str': 'env Protein gp120, HIV'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0085219', 'cui_str': 'HIV p24 antigen'}]",,0.0497038,GT gp41- and p24-specific ADNP were significantly higher in the tenofovir than the placebo arm at 6 and 12 months respectively ( p < 0.05).,"[{'ForeName': 'Kimone Leigh', 'Initials': 'KL', 'LastName': 'Fisher', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Mabuka', 'Affiliation': 'Africa Health Research Institute, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Sivro', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Sinaye', 'Initials': 'S', 'LastName': 'Ngcapu', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Jo-Ann Shelley', 'Initials': 'JS', 'LastName': 'Passmore', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Farzana', 'Initials': 'F', 'LastName': 'Osman', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Bongiwe', 'Initials': 'B', 'LastName': 'Ndlovu', 'Affiliation': 'HIV Pathogenesis Programme, The Doris Duke Medical Research Institute, Nelson R. Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Quarraisha', 'Initials': 'Q', 'LastName': 'Abdool Karim', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Salim S', 'Initials': 'SS', 'LastName': 'Abdool Karim', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Amy W', 'Initials': 'AW', 'LastName': 'Chung', 'Affiliation': 'Department of Microbiology and Immunology, The Peter Doherty Institute for Infection and Immunity, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Baxter', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Derseree', 'Initials': 'D', 'LastName': 'Archary', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa.'}]",Frontiers in immunology,['10.3389/fimmu.2020.01274'] 1178,32730613,Effect of an Early Palliative Care Telehealth Intervention vs Usual Care on Patients With Heart Failure: The ENABLE CHF-PC Randomized Clinical Trial.,"Importance National guidelines recommend early palliative care for patients with advanced heart failure, which disproportionately affects rural and minority populations. Objective To determine the effect of an early palliative care telehealth intervention over 16 weeks on the quality of life, mood, global health, pain, and resource use of patients with advanced heart failure. Design, Setting, and Participants A single-blind, intervention vs usual care randomized clinical trial was conducted from October 1, 2015, to May 31, 2019, among 415 patients 50 years or older with New York Heart Association class III or IV heart failure or American College of Cardiology stage C or D heart failure at a large Southeastern US academic tertiary medical center and a Veterans Affairs medical center serving high proportions of rural dwellers and African American individuals. Interventions The ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers) intervention comprises an in-person palliative care consultation and 6 weekly nurse-coach telephonic sessions (20-40 minutes) and monthly follow-up for 48 weeks. Main Outcomes and Measures Primary outcomes were quality of life (as measured by the Kansas City Cardiomyopathy Questionnaire [KCCQ]: score range, 0-100; higher scores indicate better perceived health status and clinical summary scores ≥50 are considered ""fairly good"" quality of life; and the Functional Assessment of Chronic Illness Therapy-Palliative-14 [FACIT-Pal-14]: score range, 0-56; higher scores indicate better quality of life) and mood (as measured by the Hospital Anxiety and Depression Scale [HADS]) over 16 weeks. Secondary outcomes were global health (Patient Reported Outcome Measurement System Global Health), pain (Patient Reported Outcome Measurement System Pain Intensity and Interference), and resource use (hospital days and emergency department visits). Results Of 415 participants (221 men; baseline mean [SD] age, 63.8 [8.5] years) randomized to ENABLE CHF-PC (n = 208) or usual care (n = 207), 226 (54.5%) were African American, 108 (26.0%) lived in a rural area, and 190 (45.8%) had a high-school education or less, and a mean (SD) baseline KCCQ score of 52.6 (21.0). At week 16, the mean (SE) KCCQ score improved 3.9 (1.3) points in the intervention group vs 2.3 (1.2) in the usual care group (difference, 1.6; SE, 1.7; d = 0.07 [95% CI, -0.09 to 0.24]) and the mean (SE) FACIT-Pal-14 score improved 1.4 (0.6) points in the intervention group vs 0.2 (0.5) points in the usual care group (difference, 1.2; SE, 0.8; d = 0.12 [95% CI, -0.03 to 0.28]). There were no relevant between-group differences in mood (HADS-anxiety, d = -0.02 [95% CI, -0.20 to 0.16]; HADS-depression, d = -0.09 [95% CI, -0.24 to 0.06]). Conclusions and Relevance This randomized clinical trial with a majority African American sample and baseline good quality of life did not demonstrate improved quality of life or mood with a 16-week early palliative care telehealth intervention. However, pain intensity and interference (secondary outcomes) demonstrated a clinically important improvement. Trial Registration ClinicalTrials.gov Identifier: NCT02505425.",2020,"At week 16, the mean (SE) KCCQ score improved 3.9 (1.3) points in the intervention group vs 2.3 (1.2) in the usual care group (difference, 1.6; SE, 1.7; d = 0.07 [95% CI, -0.09 to 0.24]) and the mean (SE) FACIT-Pal-14 score improved 1.4 (0.6) points in the intervention group vs 0.2 (0.5) points in the usual care group (difference, 1.2; SE, 0.8; d = 0.12 [95% CI, -0.03 to 0.28]).","['patients with advanced heart failure, which disproportionately affects rural and minority populations', '415 patients 50 years or older with New York Heart Association class III or IV heart failure or American College of Cardiology stage C or D heart failure at a large Southeastern US academic tertiary medical center and a Veterans Affairs medical center serving high proportions of rural dwellers and African American individuals', 'Patients and Caregivers', '415 participants (221 men', ' baseline mean [SD] age, 63.8 [8.5] years) randomized to ENABLE CHF-PC (n\u2009=\u2009208) or usual care (n\u2009=\u2009207), 226 (54.5%) were African American, 108 (26.0%) lived in a rural area, and 190 (45.8%) had a high-school education or less, and a mean (SD) baseline KCCQ score of 52.6 (21.0', 'patients with advanced heart failure', 'Patients With Heart Failure']","['early palliative care telehealth intervention', 'Early Palliative Care Telehealth Intervention vs Usual Care', 'person palliative care consultation and 6 weekly nurse-coach telephonic sessions']","['mean (SE) KCCQ score', 'pain intensity and interference', 'quality of life (as measured by the Kansas City Cardiomyopathy Questionnaire [KCCQ]: score range, 0-100; higher scores indicate better perceived health status and clinical summary scores ≥50 are considered ""fairly good"" quality of life; and the Functional Assessment of Chronic Illness Therapy-Palliative-14 [FACIT-Pal-14]: score range, 0-56; higher scores indicate better quality of life) and mood (as measured by the Hospital Anxiety and Depression Scale [HADS', 'global health (Patient Reported Outcome Measurement System Global Health), pain (Patient Reported Outcome Measurement System Pain Intensity and Interference), and resource use (hospital days and emergency department visits', 'quality of life, mood, global health, pain, and resource use', 'mood (HADS-anxiety, d\u2009', 'quality of life or mood', 'mean (SE) FACIT-Pal-14 score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4517772', 'cui_str': '415'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0441785', 'cui_str': 'Stage C'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0455002', 'cui_str': 'Education and schooling detail'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0557773', 'cui_str': 'Coach'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0030360', 'cui_str': 'Papillon-Lefèvre syndrome'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0587438', 'cui_str': 'Day hospital'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.155537,"At week 16, the mean (SE) KCCQ score improved 3.9 (1.3) points in the intervention group vs 2.3 (1.2) in the usual care group (difference, 1.6; SE, 1.7; d = 0.07 [95% CI, -0.09 to 0.24]) and the mean (SE) FACIT-Pal-14 score improved 1.4 (0.6) points in the intervention group vs 0.2 (0.5) points in the usual care group (difference, 1.2; SE, 0.8; d = 0.12 [95% CI, -0.03 to 0.28]).","[{'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Bakitas', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'J Nicholas', 'Initials': 'JN', 'LastName': 'Dionne-Odom', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Deborah B', 'Initials': 'DB', 'LastName': 'Ejem', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Wells', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Azuero', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Macy L', 'Initials': 'ML', 'LastName': 'Stockdill', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Konda', 'Initials': 'K', 'LastName': 'Keebler', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Sockwell', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Sheri', 'Initials': 'S', 'LastName': 'Tims', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Engler', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Steinhauser', 'Affiliation': 'Center for Innovation, Veterans Affairs Medical Center, Durham, North Carolina.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kvale', 'Affiliation': 'Department of Medicine, Dell Medical School, University of Texas at Austin, Austin.'}, {'ForeName': 'Raegan W', 'Initials': 'RW', 'LastName': 'Durant', 'Affiliation': 'Division of Preventive Medicine, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Rodney O', 'Initials': 'RO', 'LastName': 'Tucker', 'Affiliation': 'Division of Gerontology, Geriatrics and Palliative Care, UAB Center for Palliative and Supportive Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Burgio', 'Affiliation': 'Division of Gerontology, Geriatrics and Palliative Care, UAB Center for Palliative and Supportive Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Tallaj', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Swetz', 'Affiliation': 'Division of Gerontology, Geriatrics and Palliative Care, UAB Center for Palliative and Supportive Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Salpy V', 'Initials': 'SV', 'LastName': 'Pamboukian', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.2861'] 1179,32737210,Enhancing help-seeking behaviour among men who have sex with men at risk for sexually transmitted infections: the syn.bas.in randomised controlled trial.,"OBJECTIVES Men who have sex with men (MSM) are at increased risk for STIs and mental disorders. Syndemic theory holds that psychosocial issues co-occur and interact, and thus increase sexual risk behaviour. Psychosocial issue identification, referral and management might reduce risk behaviour. METHODS In the syndemic-based intervention study, an open-label randomised controlled trial, MSM were enrolled at the STI outpatient clinic of the Public Health Service of Amsterdam. We screened participants using validated questionnaires on the following problem domains: alcohol and substance use, sexual compulsivity, anxiety, depression, attention deficit hyperactivity disorder, alexithymia, intimate partner violence and childhood sexual abuse. Individuals were randomly assigned (1:1) to receive either tailored, face-to-face feedback and help-seeking advice on mental health screening, or no feedback and no help-seeking advice. Participants were followed trimonthly for a year. The primary outcomes were self-reported and confirmed help-seeking behaviour. RESULTS We included 155 MSM: 76 in the intervention group and 79 in the control group. At inclusion, 128 participants (83.1%) scored positive in at least one problem domain. We found no significant differences in self-reported or confirmed help-seeking behaviour between the intervention and the control group: 41% vs 29% (p=0.14) and 28% vs 22% (p=0.44), respectively. There were also no differences in STI incidence and condomless anal sex acts between the two groups. CONCLUSION Screening showed high prevalence of problems related to mental health and substance use, while tailored feedback, advice and referral did not significantly increase help-seeking behaviour. Other interventions are needed to tackle the high burden of mental disorders among MSM. TRIAL REGISTRATION NUMBER NCT02859935.",2021,"We found no significant differences in self-reported or confirmed help-seeking behaviour between the intervention and the control group: 41% vs 29% (p=0.14) and 28% vs 22% (p=0.44), respectively.","['Men who have sex with men (MSM', 'men who have sex with men at risk for sexually transmitted infections', 'screened participants using validated questionnaires on the following problem domains: alcohol and substance use, sexual compulsivity, anxiety, depression, attention deficit hyperactivity disorder, alexithymia, intimate partner violence and childhood sexual abuse', 'MSM were enrolled at the STI outpatient clinic of the Public Health Service of Amsterdam', '155 MSM: 76 in the intervention group and 79 in the control group']","['tailored, face-to-face feedback and help-seeking advice on mental health screening, or no feedback and no help-seeking advice']","['sexual risk behaviour', 'STI incidence and condomless anal sex acts', 'seeking behaviour', 'help-seeking behaviour', 'self-reported and confirmed help-seeking behaviour']","[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0002020', 'cui_str': 'Alexithymia'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0282350', 'cui_str': 'Sexual abuse'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041734', 'cui_str': 'United States. Public Health Service'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0184646', 'cui_str': 'Mental health screening'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0282347', 'cui_str': 'Anal sex'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]",155.0,0.0923846,"We found no significant differences in self-reported or confirmed help-seeking behaviour between the intervention and the control group: 41% vs 29% (p=0.14) and 28% vs 22% (p=0.44), respectively.","[{'ForeName': 'Roeland Christiaan Alfons', 'Initials': 'RCA', 'LastName': 'Achterbergh', 'Affiliation': 'STI Outpatient Clinic, Infectious Diseases Department, Public Health Sevice of Amsterdam, Amsterdam, North Holland, The Netherlands.'}, {'ForeName': 'Martijn S', 'Initials': 'MS', 'LastName': 'van Rooijen', 'Affiliation': 'STI Outpatient Clinic, Infectious Diseases Department, Public Health Sevice of Amsterdam, Amsterdam, North Holland, The Netherlands.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'van den Brink', 'Affiliation': 'Department of Psychiatry, Amsterdam UMC Location AMC, Amsterdam, North Holland, The Netherlands.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Boyd', 'Affiliation': 'Department of Infectious Diseases Research and Prevention, Public Health Service of Amsterdam, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Henry John Christiaan', 'Initials': 'HJC', 'LastName': 'de Vries', 'Affiliation': 'STI Outpatient Clinic, Infectious Diseases Department, Public Health Sevice of Amsterdam, Amsterdam, North Holland, The Netherlands h.j.devries@amc.nl.'}]",Sexually transmitted infections,['10.1136/sextrans-2020-054438'] 1180,33230541,Online psychosocial group intervention for parents: Positive effects on anxiety and depression.,"OBJECTIVE To evaluate the efficacy of an online psychosocial group intervention for parents of children with a chronic illness, in terms of anxiety and depression, and disease-related coping skills. METHODS Parents (N = 73) participated in a parallel multicenter randomized controlled trial comparing an intervention group to a waitlist control group. In the group intervention Op Koers Online (English: On Track Online) parents learned how to use adaptive coping strategies taught with cognitive behavioral therapy and acceptance and commitment therapy techniques. Assessments (online questionnaires) took place at baseline (T0), 6-months (T1), and 12-months (T2) follow-up. Mixed-model analyses were performed to test the difference in change in outcomes between intervention (N = 34) and waitlist control group (N = 33). RESULTS When compared with the waitlist control group, the intervention had a significant positive effect (p < .05) on changes in anxiety, depression, and total score T1 versus T0 (β = -.47 to -.51) and T2 versus T0 (β = -.39 to -.46), the coping skills open communication, relaxation, social support, acceptance, predictive control (β = .42-.88) and helplessness (β = -.47) T1 versus T0 and relaxation and positive thinking T2 versus T0 (β = .42-.53). CONCLUSIONS Parental anxiety and depression decreased, and use of adaptive coping skills improved after the intervention. The online character, the focus on parents themselves instead of on their child and the possibility for parents of children with rare illnesses to participate, are innovative and unique aspects of Op Koers Online for parents. The next step is to implement the intervention in clinical practice.",2021,"When compared with the waitlist control group, the intervention had a significant positive effect (p < .05) on changes in anxiety, depression, and total score T1 versus T0 (β = -.47 to -.51) and T2 versus T0 (β = -.39 to -.46), the coping skills open communication, relaxation, social support, acceptance, predictive control (β = .42-.88) and helplessness (β = -.47) T1 versus T0 and relaxation and positive thinking T2 versus T0 (β = .42-.53). ","['Parents (N\u2009=\u200973', 'parents of children with a chronic illness, in terms of anxiety and depression, and disease-related coping skills', 'English']","['waitlist control group', 'Online psychosocial group intervention', 'online psychosocial group intervention', 'adaptive coping strategies taught with cognitive behavioral therapy and acceptance and commitment therapy techniques']","['Assessments (online questionnaires) took place at baseline (T0), 6-months (T1), and 12-months (T2) follow-up', 'adaptive coping skills', 'anxiety and depression', 'changes in anxiety, depression, and total score T1', 'coping skills open communication, relaxation, social support, acceptance, predictive control (β = .42-.88) and helplessness']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0376245', 'cui_str': 'English language'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018897', 'cui_str': 'Learned Helplessness'}]",73.0,0.0347997,"When compared with the waitlist control group, the intervention had a significant positive effect (p < .05) on changes in anxiety, depression, and total score T1 versus T0 (β = -.47 to -.51) and T2 versus T0 (β = -.39 to -.46), the coping skills open communication, relaxation, social support, acceptance, predictive control (β = .42-.88) and helplessness (β = -.47) T1 versus T0 and relaxation and positive thinking T2 versus T0 (β = .42-.53). ","[{'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Douma', 'Affiliation': ""Psychosocial Department, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam.""}, {'ForeName': 'Heleen', 'Initials': 'H', 'LastName': 'Maurice-Stam', 'Affiliation': 'Department of Psychosocial Research and Care Innovation, Psychosocial Research and Care Innovation, Princess Máxima Center for Pediatric Oncology.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Gorter', 'Affiliation': 'Department of Medical Psychology, DeKinderKliniek, DeKinderGGZ.'}, {'ForeName': 'Yvette', 'Initials': 'Y', 'LastName': 'Krol', 'Affiliation': 'Department of Medical Psychology, Deventer Hospital.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Verkleij', 'Affiliation': 'Department of Medical Psychology, Amsterdam University Medical Centers, location VUmc.'}, {'ForeName': 'Lianne', 'Initials': 'L', 'LastName': 'Wiltink', 'Affiliation': 'Department of Medical Psychology, Canisius Wilhelmina Hospital.'}, {'ForeName': 'Linde', 'Initials': 'L', 'LastName': 'Scholten', 'Affiliation': ""Psychosocial Department, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam.""}, {'ForeName': 'Martha A', 'Initials': 'MA', 'LastName': 'Grootenhuis', 'Affiliation': 'Department of Psychosocial Research and Care Innovation, Psychosocial Research and Care Innovation, Princess Máxima Center for Pediatric Oncology.'}]",Journal of pediatric psychology,['10.1093/jpepsy/jsaa102'] 1181,32748972,Theory of mind and loneliness: Effects of a conversation-based training at school.,"Conversation-based training programmes are known to be effective in enhancing theory of mind (ToM). The possible consequences of such training programmes on the understanding of other constructs have rarely been investigated. The present research aimed to evaluate the effects of two different types of conversation-based training on ToM and loneliness. Two hundred and ten fourth and fifth graders (52% boys; Mage = 9.66 years, SD = 0.85), randomly divided into two groups (ToM and no-ToM training condition), were administered at a 5-week intervention. ToM and loneliness were measured before and twice after the intervention (1 week and 2 months later). Linear mixed-effects models showed that, soon after the intervention, children in the ToM training condition obtained significantly higher ToM scores and significantly lower loneliness scores compared to children in the no-ToM training condition. Nonetheless, at the follow-up, ToM and loneliness scores were not significantly different for the two training conditions. These findings suggest that a relatively short intervention based on group discussion of mental states is sufficient to improve mentalizing abilities and to tackle feelings of loneliness among fourth and fifth graders in the short but not in the long term.",2021,"Linear mixed-effects models showed that, soon after the intervention, children in the ToM training condition obtained significantly higher ToM scores and significantly lower loneliness scores compared to children in the no-ToM training condition.","['Two hundred and ten fourth and fifth graders (52% boys; Mage\xa0=\xa09.66\u2009years, SD\xa0=\xa00.85']","['conversation-based training', 'conversation-based training at school', 'Conversation-based training programmes']","['ToM and loneliness', 'ToM and loneliness scores', 'mentalizing abilities', 'loneliness scores', 'ToM scores']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517483', 'cui_str': '0.85'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0935573', 'cui_str': 'Theory of Mind'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",210.0,0.014564,"Linear mixed-effects models showed that, soon after the intervention, children in the ToM training condition obtained significantly higher ToM scores and significantly lower loneliness scores compared to children in the no-ToM training condition.","[{'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Caputi', 'Affiliation': 'Department of Psychology, University of Turin, Turin, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Cugnata', 'Affiliation': 'University Centre for Statistics in the Biomedical Sciences, Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Brombin', 'Affiliation': 'University Centre for Statistics in the Biomedical Sciences, Vita-Salute San Raffaele University, Milan, Italy.'}]",International journal of psychology : Journal international de psychologie,['10.1002/ijop.12707'] 1182,32749942,Efficacy of Maintenance Olaparib for Patients With Newly Diagnosed Advanced Ovarian Cancer With a BRCA Mutation: Subgroup Analysis Findings From the SOLO1 Trial.,"PURPOSE In SOLO1, maintenance olaparib (300 mg twice daily) significantly improved progression-free survival (PFS) for patients with newly diagnosed BRCA1 - and/or BRCA2 -mutated advanced ovarian cancer compared with placebo (hazard ratio [HR], 0.30; 95% CI, 0.23 to 0.41; median not reached v 13.8 months). We investigated PFS in SOLO1 for subgroups of patients based on preselected baseline factors. PATIENTS AND METHODS Investigator-assessed PFS subgroup analyses of SOLO1 included clinical response after platinum-based chemotherapy (complete [CR] or partial response [PR]), surgery type (upfront or interval surgery), disease status after surgery (residual or no gross residual disease), and BRCA mutation status ( BRCA1 or BRCA2 ). Additionally, we evaluated PFS in patients with stage III disease who underwent upfront surgery and had no gross residual disease. We also report objective response rate. RESULTS The risk of disease progression or death was reduced with olaparib compared with placebo by 69% (HR, 0.31; 95% CI, 0.21 to 0.46) and 63% (HR, 0.37; 95% CI, 0.24 to 0.58) in patients undergoing upfront or interval surgery; 56% (HR, 0.44; 95% CI, 0.25 to 0.77) and 67% (HR, 0.33; 95% CI, 0.23 to 0.46) in patients with residual or no residual disease after surgery; 66% (HR, 0.34; 95% CI, 0.24 to 0.47) and 69% in women with clinical CR or PR at baseline (HR, 0.31; 95% CI, 0.18 to 0.52); and 59% (HR, 0.41; 95% CI, 0.30 to 0.56) and 80% (HR 0.20; 95% CI, 0.10 to 0.37) in patients with a BRCA1 or BRCA2 mutation, respectively. CONCLUSION Patients with newly diagnosed advanced ovarian cancer achieve substantial benefit from maintenance olaparib treatment regardless of baseline surgery outcome, response to chemotherapy, or BRCA mutation type.",2020,"The risk of disease progression or death was reduced with olaparib compared with placebo by 69% (HR, 0.31; 95% CI, 0.21 to 0.46) and 63% (HR, 0.37; 95% CI, 0.24 to 0.58) in patients undergoing upfront or interval surgery; 56% (HR, 0.44; 95% CI, 0.25 to 0.77) and 67% (HR, 0.33; 95% CI, 0.23 to 0.46) in patients with residual or no residual disease after surgery; 66% (HR, 0.34; 95% CI, 0.24 to 0.47) and 69% in women with clinical CR or PR at baseline (HR, 0.31; 95% CI, 0.18 to 0.52); and 59% (HR, 0.41; 95% CI, 0.30 to 0.56) and 80% (HR 0.20; 95% CI, 0.10 to 0.37) in patients with a BRCA1 or BRCA2 mutation, respectively. ","['Patients With Newly Diagnosed Advanced Ovarian Cancer', 'Patients with newly diagnosed advanced ovarian cancer', 'patients with stage III disease who underwent upfront surgery and had no gross residual disease']","['Maintenance Olaparib', 'platinum-based chemotherapy (complete [CR] or partial response [PR]), surgery type (upfront or interval surgery', 'placebo']","['progression-free survival (PFS', 'risk of disease progression or death', 'disease status after surgery (residual or no gross residual disease), and BRCA mutation status ( BRCA1 or BRCA2 ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumour'}]","[{'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumour'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1528558', 'cui_str': 'BRCA1 protein, human'}, {'cui': 'C2973986', 'cui_str': 'BRCA2 protein, human'}]",,0.426993,"The risk of disease progression or death was reduced with olaparib compared with placebo by 69% (HR, 0.31; 95% CI, 0.21 to 0.46) and 63% (HR, 0.37; 95% CI, 0.24 to 0.58) in patients undergoing upfront or interval surgery; 56% (HR, 0.44; 95% CI, 0.25 to 0.77) and 67% (HR, 0.33; 95% CI, 0.23 to 0.46) in patients with residual or no residual disease after surgery; 66% (HR, 0.34; 95% CI, 0.24 to 0.47) and 69% in women with clinical CR or PR at baseline (HR, 0.31; 95% CI, 0.18 to 0.52); and 59% (HR, 0.41; 95% CI, 0.30 to 0.56) and 80% (HR 0.20; 95% CI, 0.10 to 0.37) in patients with a BRCA1 or BRCA2 mutation, respectively. ","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'DiSilvestro', 'Affiliation': 'Women & Infants Hospital, Providence, RI.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': 'European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), University of Milan-Bicocca, Milan, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': 'Fondazione Policlinico Universitario A Gemelli, IRCCS, Università Cattolica, Rome, Italy.'}, {'ForeName': 'Byoung-Gie', 'Initials': 'BG', 'LastName': 'Kim', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Oaknin', 'Affiliation': ""Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Friedlander', 'Affiliation': 'University of New South Wales Clinical School, Prince of Wales Hospital, Randwick, New South Wales, Australia.'}, {'ForeName': 'Alla', 'Initials': 'A', 'LastName': 'Lisyanskaya', 'Affiliation': 'St Petersburg City Oncology Dispensary, St Petersburg, Russia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Floquet', 'Affiliation': 'Institut Bergonié, Comprehensive Cancer Centre, Bordeaux, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Leary', 'Affiliation': 'Gustave-Roussy Cancer Campus, Villejuif, France.'}, {'ForeName': 'Gabe S', 'Initials': 'GS', 'LastName': 'Sonke', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Gourley', 'Affiliation': 'Cancer Research UK Edinburgh Centre, Institute of Genetics and Molecular Medicine, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'The Royal Marsden National Health Service Foundation Trust and Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Oza', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'González-Martín', 'Affiliation': 'Clínica Universidad de Navarra, Madrid, Spain.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Aghajanian', 'Affiliation': 'Memorial Sloan-Kettering Cancer Center, New York, NY.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Bradley', 'Affiliation': 'Froedtert and the Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Cara A', 'Initials': 'CA', 'LastName': 'Mathews', 'Affiliation': 'Women & Infants Hospital, Providence, RI.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Lowe', 'Affiliation': 'AstraZeneca, Gaithersburg, MD.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Bloomfield', 'Affiliation': 'AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Kathleen N', 'Initials': 'KN', 'LastName': 'Moore', 'Affiliation': 'Stephenson Cancer Center, University of Oklahoma, Oklahoma City, OK.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00799'] 1183,33230718,Implementing a new method of group toilet training in daycare centres: a cluster randomised controlled trial.,"Despite the existing methods, a trend towards a later initiation and completion of toilet training has been seen in Western society. This study is the first to investigate prospectively the efficacy of intensive group toilet training in daycare centres. The primary outcome of interest is the duration until the child is toilet trained. A cluster randomised controlled trial was established in daycare centres; clusters of participants were randomly allocated to an intervention or control group. Intervention group was subjected to an intensive toilet training session. Innovative aspects of this toilet training method were a 2-h training on two consecutive days, carried out in small groups in daycare centres. Parents of children in the control group were encouraged to start TT in their own manner. Children were monitored until they were considered to be fully toilet trained during the day. Median toilet training duration in the intervention group was 2 weeks compared to 5 weeks in controls (p value log rank test = 0.007). The hazard of being clean during the follow-up of 6 weeks was twice as high in the intervention compared to controls (p = 0.018).Conclusion: The intervention had a significant influence on the duration of toilet training in healthy children, with a median duration of 2 weeks. Our findings are clinically relevant for daycare educators, having a considerable responsibility in the development of children.Trial Registration Number: ClinicalTrials.gov NCT04221776. What is Known: • Despite different existing methods, a later initiation of toilet training has been seen in Western society and coherent to this an increasing age of acquiring full bladder control. • Child daycare centres have a growing role in the toilet training process. What is New: • This is the first prospective report describing the results of a new method of toilet training healthy children in small groups in daycare centres. • The intervention had a significant influence on the duration of toilet training, with a median duration of 2 weeks.",2021,The hazard of being clean during the follow-up of 6 weeks was twice as high in the intervention compared to controls (p = 0.018).Conclusion:,"['daycare centres', 'healthy children', 'healthy children in small groups in daycare centres', 'daycare centres; clusters of participants']","['intensive toilet training session', 'intensive group toilet training', 'toilet training']","['duration of toilet training, with a median duration of 2\xa0weeks', 'hazard of being clean', 'Median toilet training duration', 'duration of toilet training', 'duration until the child is toilet trained']","[{'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}]","[{'cui': 'C0040365', 'cui_str': 'Child continence training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040365', 'cui_str': 'Child continence training'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0700127', 'cui_str': 'Toilet trained'}]",,0.0530527,The hazard of being clean during the follow-up of 6 weeks was twice as high in the intervention compared to controls (p = 0.018).Conclusion:,"[{'ForeName': 'Tinne', 'Initials': 'T', 'LastName': 'Van Aggelpoel', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, 2610 Wilrijk, Antwerp, Belgium. tinne.vanaggelpoel@uantwerpen.be.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'De Wachter', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, 2610 Wilrijk, Antwerp, Belgium.'}, {'ForeName': 'Hedwig', 'Initials': 'H', 'LastName': 'Neels', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, 2610 Wilrijk, Antwerp, Belgium.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Van Hal', 'Affiliation': 'Social Epidemiology and Health Policy, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Roelant', 'Affiliation': 'Clinical Trial Center (CTC), CRC Antwerp, Antwerp University Hospital - University of Antwerp, Edegem, Belgium.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Vermandel', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, 2610 Wilrijk, Antwerp, Belgium.'}]",European journal of pediatrics,['10.1007/s00431-020-03879-y'] 1184,32762792,The Art of Remediating Age-Related Cognitive Decline: Art Therapy Enhances Cognition and Increases Cortical Thickness in Mild Cognitive Impairment.,"OBJECTIVE Previous research on art therapy (AT) in cognitive aging has been lacking. AT can potentially engender significant cognitive gains, due to its rigorous cognitive involvement, making it useful to tackle age-related cognitive decline. Along with these cognitive gains, associated neuroplastic changes are hypothesized to arise from AT as well. The current intervention examined the effects of an AT intervention on cognitive outcomes and cortical thickness (CT) among participants with mild cognitive impairment. METHOD Participants were assigned to AT (n = 22) and an active control group (n = 27). In both, weekly 45-min sessions were carried out across 3 months. Cognitive assessments and structural magnetic resonance imaging scans were carried out at baseline and 3-month follow-up. Whole brain analyses on CT were carried out. Cognitive outcomes were analyzed using hierarchical linear models. RESULTS Significant gains in immediate memory and working memory span were observed in the AT group, relative to the control group. Significantly increased CT in the AT group, relative to controls, was observed in a right middle frontal gyrus (MFG) cluster. Furthermore, CT changes in this cluster were significantly and positively correlated with changes in immediate memory. CONCLUSION These findings highlighted the role of MFG neuroplasticity in enhancing certain cognitive functions in AT. AT is a neuroplastic intervention capable of engendering significant cognitive gains and associated cortical changes in the context of age-related cognitive decline, even when executed as a low-intensity intervention across 3 months. Given the preliminary nature of these findings, future larger sampled studies are needed.",2021,"Significantly increased CT in the AT group, relative to controls, was observed in a right middle frontal gyrus (MFG) cluster.","['Mild Cognitive Impairment', 'Participants were assigned to AT (n = 22) and an active control group (n = 27', 'participants with mild cognitive impairment']",['AT intervention'],"['immediate memory and working memory span', 'cognitive outcomes and cortical thickness (CT', 'Cognitive outcomes', 'CT', 'immediate memory']","[{'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0003827', 'cui_str': 'Art therapy'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0003827', 'cui_str': 'Art therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",27.0,0.0134496,"Significantly increased CT in the AT group, relative to controls, was observed in a right middle frontal gyrus (MFG) cluster.","[{'ForeName': 'Junhong', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Psychological Medicine, Mind Science Centre, Yong Loo Lin School of Medicine, National University of Singapore, 119077 Singapore, Singapore.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Rawtaer', 'Affiliation': 'Department of Psychiatry, Sengkang General Hospital, 544886 Singapore, Singapore.'}, {'ForeName': 'Lee Gan', 'Initials': 'LG', 'LastName': 'Goh', 'Affiliation': 'Department of Family Medicine, National University Health System, 119228 Singapore, Singapore.'}, {'ForeName': 'Alan Prem', 'Initials': 'AP', 'LastName': 'Kumar', 'Affiliation': 'Department of Pharmacology, Yong Loo Lin School of Medicine, National University of Singapore, 117600 Singapore, Singapore.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': 'Department of Psychological Medicine, Mind Science Centre, Yong Loo Lin School of Medicine, National University of Singapore, 119077 Singapore, Singapore.'}, {'ForeName': 'Ee Heok', 'Initials': 'EH', 'LastName': 'Kua', 'Affiliation': 'Department of Psychological Medicine, Mind Science Centre, Yong Loo Lin School of Medicine, National University of Singapore, 119077 Singapore, Singapore.'}, {'ForeName': 'Rathi', 'Initials': 'R', 'LastName': 'Mahendran', 'Affiliation': 'Department of Psychological Medicine, Mind Science Centre, Yong Loo Lin School of Medicine, National University of Singapore, 119077 Singapore, Singapore.'}]",Journal of the International Neuropsychological Society : JINS,['10.1017/S1355617720000697'] 1185,32763006,Polyethylene Wear With Ceramic and Metal Femoral Heads at 5 Years: A Randomized Controlled Trial With Radiostereometric Analysis.,"BACKGROUND A common bearing combination in total hip arthroplasty today is a metal femoral head articulating with polyethylene in the cup. Ceramic heads are thought to be more resistant to third-body damage, and have better wettability and decreased surface roughness, which taken together have been suggested to result in less polyethylene wear. The purpose of this study is to compare the initial creep deformation and follow wear pattern, using radiostereometric analysis, of ceramic and metal femoral heads that articulate with a modern highly cross-linked polyethylene cup liner. METHODS Fifty patients with primary osteoarthritis and scheduled for an uncemented total hip arthroplasty were randomized 1:1 to either a ceramic (BIOLOX delta) or a metal (CoCr) femoral head. The patients were followed up for 5 years with repeated radiostereometric analysis examinations (postoperatively, then at 14 days, 3, 12, 24, and 60 months), as well as a hip-specific outcome questionnaire. RESULTS During the first 3 months both groups showed expected creep within the liner of 0.12 mm (standard deviation 0.03) for the ceramic and 0.08 mm (standard deviation 0.02) for the metal heads. Between 3 months and 5 years there was very little wear of the liner in either group, corresponding to 0.003 mm/y for ceramic and 0.007 mm/y for metal heads. There was no difference in cup migration or clinical outcome between the groups and no cups were revised. CONCLUSION With the introduction of modern highly cross-linked polyethylene, the ceramic head demonstrates no superiority when it comes to either early deformation or polyethylene wear compared with the metal head.",2020,"There was no difference in cup migration or clinical outcome between the groups and no cups were revised. ","['at 5 Years', 'Fifty patients with primary osteoarthritis and scheduled for an uncemented total hip arthroplasty']","['modern highly cross-linked polyethylene', 'Polyethylene Wear With Ceramic and Metal Femoral Heads', 'ceramic (BIOLOX delta) or a metal (CoCr) femoral head']",['cup migration or clinical outcome'],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409952', 'cui_str': 'Idiopathic osteoarthritis'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0032487', 'cui_str': 'Polyethylenes'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0015813', 'cui_str': 'Structure of head of femur'}, {'cui': 'C0439097', 'cui_str': 'Delta'}]","[{'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",50.0,0.0929279,"There was no difference in cup migration or clinical outcome between the groups and no cups were revised. ","[{'ForeName': 'Halldor', 'Initials': 'H', 'LastName': 'Bergvinsson', 'Affiliation': 'Department of Orthopedics, Clinical Sciences, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sundberg', 'Affiliation': 'Department of Orthopedics, Clinical Sciences, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Flivik', 'Affiliation': 'Department of Orthopedics, Clinical Sciences, Lund University, Skåne University Hospital, Lund, Sweden.'}]",The Journal of arthroplasty,['10.1016/j.arth.2020.06.057'] 1186,32781433,Promotion of Healthy Aging Within a Community Center Through Behavior Change: Health and Fitness Findings From the AgeWell Pilot Randomized Controlled Trial.,"The purpose of this randomized controlled trial was to determine if behavior change through individual goal setting (GS) could promote healthy aging, including health and fitness benefits in older adults who attended a community ""AgeWell"" Center for 12 months. Seventy-five older adults were randomly allocated to either a control or a GS group. Health outcomes were measured at baseline and after 12 months of the participants' having access to the exception of Agewell Center facilities. The findings demonstrate that participation in the Center in itself was beneficial, with improved body composition and reduced cardiovascular risk in both groups (p < .05), and that this kind of community-based resource offers valuable potential for promoting protective behaviors and reducing health risk. However, a specific focus on identifying individual behavior change goals was required in order to achieve increased activity engagement (p < .05) and to bring about more substantial improvements in a range of health, diet, and physical function measures (p < .05).",2020,"The findings demonstrate that participation in the Center in itself was beneficial, with improved body composition and reduced cardiovascular risk in both groups (p < .05), and that this kind of community-based resource offers valuable potential for promoting protective behaviors and reducing health risk.","['older adults who attended a community ""AgeWell"" Center for 12 months', 'Seventy-five older adults']",['individual goal setting (GS'],"['Health outcomes', 'body composition and reduced cardiovascular risk', 'activity engagement']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4319621', 'cui_str': '75'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]",75.0,0.0605384,"The findings demonstrate that participation in the Center in itself was beneficial, with improved body composition and reduced cardiovascular risk in both groups (p < .05), and that this kind of community-based resource offers valuable potential for promoting protective behaviors and reducing health risk.","[{'ForeName': 'Jeanette M', 'Initials': 'JM', 'LastName': 'Thom', 'Affiliation': ''}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Nelis', 'Affiliation': ''}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Cooney', 'Affiliation': ''}, {'ForeName': 'John V', 'Initials': 'JV', 'LastName': 'Hindle', 'Affiliation': ''}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Clare', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2019-0396'] 1187,32789809,Pharmacokinetic and Pharmacodynamic Equivalence of Pegfilgrastim-cbqv and Pegfilgrastim in Healthy Subjects.,"INTRODUCTION Pegfilgrastim-cbqv was developed as a biosimilar of pegfilgrastim, a pegylated form of recombinant human granulocyte colony-stimulating factor approved for decreasing febrile neutropenia-associated infection in patients receiving myelosuppressive drugs. This multicenter, randomized, single-blind, partial-reference-replicated, three-sequence crossover study assessed pharmacokinetic and pharmacodynamic bioequivalence of pegfilgrastim-cbqv and pegfilgrastim in healthy subjects. METHODS One hundred twenty-two subjects were randomized to one of three treatment sequences; each included one dose of pegfilgrastim-cbqv and two doses of pegfilgrastim separated by ≥ 28 days. The primary pharmacokinetic end points were area under the curve (AUC) from 0 to infinity (AUC 0-∞ ) and maximum concentration (C max ). The primary pharmacodynamic end points were maximum absolute neutrophil count (ANC max ) and ANC AUC from time 0 to the last measurable observation (ANC AUC 0-last ). Pharmacokinetic and pharmacodynamic bioequivalences were demonstrated if the 90% CI for the geometric mean ratio (GMR) of pegfilgrastim-cbqv to pegfilgrastim was within 80-125% for the primary end points. RESULTS Pharmacokinetic bioequivalence criteria were met for C max (GMR 105.0; 90% CI 95.5-115.4) and AUC 0-∞ (GMR 97.5; 90% CI 88.6-107.2). Pharmacodynamic bioequivalence criteria were met for ANC max (GMR 99.6; 90% CI 96.2-103.2) and ANC AUC 0-last (GMR 96.7; 90% CI 92.2-101.4). Adverse events occurred in 76.0%, 76.6%, and 73.1% of subjects for pegfilgrastim-cbqv, first pegfilgrastim, and second pegfilgrastim dosing periods across treatment sequences, respectively. Investigators found no drug-related serious adverse events. CONCLUSION This study established pharmacokinetic and pharmacodynamic bioequivalence of pegfilgrastim-cbqv to pegfilgrastim. The treatments displayed similar safety profiles, including immunogenicity, with no unexpected safety findings. CLINICAL TRIALS REGISTRATION ClinicalTrials.gov, NCT02650973, February 2016.",2020,"Adverse events occurred in 76.0%, 76.6%, and 73.1% of subjects for pegfilgrastim-cbqv, first pegfilgrastim, and second pegfilgrastim dosing periods across treatment sequences, respectively.","['One hundred twenty-two subjects', 'patients receiving myelosuppressive drugs', 'healthy subjects', 'Healthy Subjects']","['pegfilgrastim-cbqv and pegfilgrastim', 'pegfilgrastim-cbqv and two doses of pegfilgrastim separated by\u2009≥', 'recombinant human granulocyte colony-stimulating factor', 'Pegfilgrastim-cbqv and Pegfilgrastim', 'pegfilgrastim-cbqv to pegfilgrastim']","['geometric mean ratio (GMR) of pegfilgrastim-cbqv to pegfilgrastim', 'area under the curve (AUC) from 0 to infinity (AUC 0-∞ ) and maximum concentration (C max ', 'Adverse events', 'pharmacokinetic and pharmacodynamic bioequivalence', 'Pharmacokinetic and pharmacodynamic bioequivalences', 'Pharmacokinetic and Pharmacodynamic Equivalence', 'maximum absolute neutrophil count (ANC max ) and ANC AUC from time 0 to the last measurable observation (ANC AUC 0-last ']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4735048', 'cui_str': 'pegfilgrastim-cbqv'}, {'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C1271481', 'cui_str': 'Recombinant human granulocyte colony stimulating factor'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4735048', 'cui_str': 'pegfilgrastim-cbqv'}, {'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0039789', 'cui_str': 'Equivalencies, Therapeutic'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]",122.0,0.0612766,"Adverse events occurred in 76.0%, 76.6%, and 73.1% of subjects for pegfilgrastim-cbqv, first pegfilgrastim, and second pegfilgrastim dosing periods across treatment sequences, respectively.","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Finck', 'Affiliation': 'Coherus BioSciences, Redwood City, CA, USA. bfinck@coherus.com.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': 'Coherus BioSciences, Redwood City, CA, USA.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Civoli', 'Affiliation': 'Coherus BioSciences, Redwood City, CA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hodge', 'Affiliation': 'Coherus BioSciences, Redwood City, CA, USA.'}, {'ForeName': 'Hillary', 'Initials': 'H', 'LastName': ""O'Kelly"", 'Affiliation': 'Coherus BioSciences, Redwood City, CA, USA.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Vexler', 'Affiliation': 'Coherus BioSciences, Redwood City, CA, USA.'}]",Advances in therapy,['10.1007/s12325-020-01459-y'] 1188,33230010,Reduction in movement-evoked pain and fatigue during initial 30-minute transcutaneous electrical nerve stimulation treatment predicts transcutaneous electrical nerve stimulation responders in women with fibromyalgia.,"ABSTRACT We previously showed that 1 month of transcutaneous electrical nerve stimulation (TENS) reduces movement-evoked pain and fatigue in women with fibromyalgia (FM). Using data from this study (Fibromyalgia Activity Study with TENS [FAST]), we performed a responder analysis to identify predictors of clinical improvement in pain and fatigue with TENS, validated these models using receiver operator characteristic, and determined number needed to treat and number needed to harm. Participants were randomly assigned to active-TENS (2-125 Hz; highest-tolerable intensity), placebo-TENS, or no-TENS for 1 month. At the end of the randomized phase, placebo-TENS and no-TENS groups received active-TENS for 1 month. The predictor model was developed using data from the randomized phase for the active-TENS group (n = 103) and validated using data from placebo-TENS and no-TENS groups after active-TENS for 1 month (n = 155). Participant characteristics, initial response to TENS for pain and fatigue, sleep, psychological factors, and function were screened for association with changes in pain or fatigue using a logistic regression model. Predictors of clinical improvement in pain were initial response to pain and widespread pain index (area under the curve was 0.80; 95% confidence interval: 0.73-0.87). Predictors of clinical improvement in fatigue were marital status, sleep impairment, and initial response to TENS (area under the curve was 0.67; 95% confidence interval: 0.58-0.75). Number needed to treat for pain and fatigue ranged between 3.3 and 5.3. Number needed to harm ranged from 20 to 100 for minor TENS-related adverse events. The response to an initial 30-minute TENS treatment predicts who responds to longer-term TENS use in women with FM, making this a clinically useful procedure. Number needed to treat and number needed to harm suggest that TENS is effective and safe for managing pain and fatigue in FM.",2021,"Predictors of clinical improvement in fatigue were marital status, sleep impairment and initial response to TENS","['women with fibromyalgia (FM', 'women with fibromyalgia']","['placebo-TENS and no-TENS', 'Transcutaneous Electrical Nerve Stimulation (TENS', 'TENS, FAST', 'NNT', 'active-TENS (2-125Hz; highest-tolerable intensity), placebo-TENS, or no-TENS for 1-month', 'NNT and NNH suggests TENS']","['pain and fatigue, sleep, psychological factors, and function', 'pain and fatigue', 'pain and widespread pain index', 'fatigue were marital status, sleep impairment and initial response to TENS']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027552', 'cui_str': 'Needed'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0033898', 'cui_str': 'Factors, Psychological'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205219', 'cui_str': 'Diffuse'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0024819', 'cui_str': 'Marital status'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}]",,0.250365,"Predictors of clinical improvement in fatigue were marital status, sleep impairment and initial response to TENS","[{'ForeName': 'Carol G T', 'Initials': 'CGT', 'LastName': 'Vance', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Iowa, Iowa City, IA, United States.'}, {'ForeName': 'M Bridget', 'Initials': 'MB', 'LastName': 'Zimmerman', 'Affiliation': 'College of Public Health, University of Iowa, Iowa City, IA, United States.'}, {'ForeName': 'Dana L', 'Initials': 'DL', 'LastName': 'Dailey', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Iowa, Iowa City, IA, United States.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Rakel', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Iowa, Iowa City, IA, United States.'}, {'ForeName': 'Katharine M', 'Initials': 'KM', 'LastName': 'Geasland', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Iowa, Iowa City, IA, United States.'}, {'ForeName': 'Ruth L', 'Initials': 'RL', 'LastName': 'Chimenti', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Iowa, Iowa City, IA, United States.'}, {'ForeName': 'Jon M', 'Initials': 'JM', 'LastName': 'Williams', 'Affiliation': 'Department of Medicine/Rheumatology and Immunology, Vanderbilt Medical Center, Nashville, TN, United States.'}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Golchha', 'Affiliation': 'Department of Medicine/Rheumatology and Immunology, Vanderbilt Medical Center, Nashville, TN, United States.'}, {'ForeName': 'Leslie J', 'Initials': 'LJ', 'LastName': 'Crofford', 'Affiliation': 'Department of Medicine/Rheumatology and Immunology, Vanderbilt Medical Center, Nashville, TN, United States.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Sluka', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Iowa, Iowa City, IA, United States.'}]",Pain,['10.1097/j.pain.0000000000002144'] 1189,32729970,A technology-based information and coaching/support program and self-efficacy of Asian American breast cancer survivors.,"Women's self-efficacy for coping with breast cancer is one of the key factors that lead to successful breast cancer survivorship. Due to the cultural stigma linked to breast cancer (e.g., breast cancer is a genetic disease), Asian Americans are known as a high-risk group within breast cancer survivors. However, healthcare providers are challenged to promote women's self-efficacy while considering their cultural beliefs and attitudes. In this study, the efficacy of a technology-based information and coaching/support program was examined in improving self-efficacy for coping with breast cancer among Asian American survivors. A randomized repeated measures control group study was conducted with 67 Asian American breast cancer survivors. The questions on background characteristics, the Personal Resource Questionnaire, the Perceived Isolation Scale, the Supportive Care Needs Survey Short Form 34, and the Cancer Behavior Inventory were used. The data were analyzed using repeated measurement analyses, χ 2 tests, and decision tree analyses. There were significant increases in the self-efficacy scores of both control and intervention groups over time (p = .017). However, the increase in the control group's self-efficacy scores was only up to post 1 month, and there was a decrease in the scores by post 3 months. When the participants were divided into high and low-change groups based on the changes in their self-efficacy scores for 3 months, the intervention group had more participants who belonged to the high-change group (p = .036). The technology-based intervention was effective in improving self-efficacy for coping with breast cancer among Asian American breast cancer survivors.",2021,The technology-based intervention was effective in improving self-efficacy for coping with breast cancer among Asian American breast cancer survivors.,"['Asian American breast cancer survivors', 'Asian American survivors', '67 Asian American breast cancer survivors']",['technology-based information and coaching/support program'],['self-efficacy scores'],"[{'cui': 'C0003988', 'cui_str': 'Asian Americans'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",67.0,0.0110013,The technology-based intervention was effective in improving self-efficacy for coping with breast cancer among Asian American breast cancer survivors.,"[{'ForeName': 'Eun-Ok', 'Initials': 'EO', 'LastName': 'Im', 'Affiliation': 'Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Jee-Seon', 'Initials': 'JS', 'LastName': 'Yi', 'Affiliation': 'Duke University, Durham, North Carolina.'}, {'ForeName': 'Hyeoneui', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Duke University, Durham, North Carolina.'}, {'ForeName': 'Wonshik', 'Initials': 'W', 'LastName': 'Chee', 'Affiliation': 'Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, Georgia.'}]",Research in nursing & health,['10.1002/nur.22059'] 1190,32739080,No Major Functional Benefit After Bicompartmental Knee Arthroplasty Compared to Total Knee Arthroplasty at 5-Year Follow-Up.,"BACKGROUND In case of isolated medial and patellofemoral joint arthritis, bicompartmental knee arthroplasty (BCA) is an alternative to total knee arthroplasty (TKA). The purpose of our prospective, randomized study is to compare the clinical outcome of BCA vs TKA. METHODS Eighty patients with isolated medial and patellofemoral osteoarthritis were randomly assigned to either BCA or TKA. Patients were evaluated preoperatively, 3, 6, and 12 months, and 2 and 5 years after the procedure. Knee Society Score, Oxford Knee Score, and the University of California,Los Angeles activity scores were calculated at each follow-up; Forgotten Joint Score was assessed at final follow-up. RESULTS There was an improvement in Knee Society Score, Oxford Knee Score, and the University of California,Los Angeles scores in both groups but no significant differences between both groups at any follow-up. The Forgotten Joint Score at 5-year follow-up was not significantly different either. Range of motion was significantly greater in the BCA group from 1-year follow-up onward. CONCLUSION Our study did not show significant differences in clinical scores between BCA and TKA; only range of motion was significantly greater in BCA. Therefore, it is questionable whether this difference justifies the complexity of BCA associated with higher risk of failure. Maybe staged patellofemoral joint arthroplasty in the presence of a well-functioning UKA is an option for BCA and an alternative to revision to TKA. Long-term studies are needed to explore the potential benefits of BCA.",2020,Our study did not show significant differences in clinical scores between BCA and TKA; only range of motion was significantly greater in BCA.,['Eighty patients with isolated medial and patellofemoral osteoarthritis'],"['BCA', 'BCA or TKA', 'bicompartmental knee arthroplasty (BCA']","['Knee Society Score, Oxford Knee Score, and the University of California,Los Angeles activity scores', 'Knee Society Score, Oxford Knee Score, and the University of California,Los Angeles scores', 'Range of motion', 'Forgotten Joint Score']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C1542808', 'cui_str': 'Patellofemoral osteoarthritis'}]","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C4759288', 'cui_str': 'Forgotten Joint Score'}]",80.0,0.0372399,Our study did not show significant differences in clinical scores between BCA and TKA; only range of motion was significantly greater in BCA.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schrednitzki', 'Affiliation': 'Department of Orthopaedic Surgery, Kremmen, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Beier', 'Affiliation': 'Department of Orthopaedic Surgery, Kremmen, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Marx', 'Affiliation': 'Department of Orthopaedic Surgery, Kremmen, Germany.'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Halder', 'Affiliation': 'Department of Orthopaedic Surgery, Kremmen, Germany.'}]",The Journal of arthroplasty,['10.1016/j.arth.2020.07.003'] 1191,32755372,Normoxic management of cardiopulmonary bypass reduces myocardial oxidative stress in adult patients undergoing coronary artery bypass graft surgery.,"INTRODUCTION We aimed to investigate whether normoxic cardiopulmonary bypass would limit myocardial oxidative stress in adults undergoing coronary artery bypass grafting. METHODS Patients scheduled to undergo elective isolated on-pump coronary artery bypass grafting were randomized to normoxia and hyperoxia groups. The normoxia group received 35% oxygen during anesthetic induction, 35% during hypothermic bypass, and 45% during rewarming. The hyperoxia group received 70%, 50%, and 70% oxygen, respectively. Coronary sinus blood samples were taken prior to initiation of cardiopulmonary bypass and after reperfusion for myocardial total oxidant and antioxidant status measurements. The primary endpoint was myocardial total oxidant status. Secondary endpoints were myocardial total antioxidant status and length of intensive care unit and hospital stay. RESULTS Forty-eight patients were included. Twenty-two received normoxic management. Mean ± standard deviation of age was 58 ± 9.07 years. Groups were balanced in terms of demographics, risk factors, and operative data. Myocardial total oxidant status was significantly lower in the normoxia group following reperfusion (p = 0.03). There was no statistically significant difference regarding myocardial total antioxidant status and length of intensive care unit and hospital stay (p = 0.08, p = 0.82, and p = 0.54, respectively). CONCLUSIONS Normoxic cardiopulmonary bypass is associated with reduced myocardial oxidative stress compared to hyperoxic cardiopulmonary bypass in adult coronary artery bypass patients.",2021,"There was no statistically significant difference regarding myocardial total antioxidant status and length of intensive care unit and hospital stay (p = 0.08, p = 0.82, and p = 0.54, respectively). ","['Forty-eight patients were included', 'adult coronary artery bypass patients', 'Patients scheduled to undergo elective isolated on-pump coronary artery bypass grafting were randomized to normoxia and hyperoxia groups', 'adult patients undergoing coronary artery bypass graft surgery', 'adults undergoing coronary artery bypass grafting']","['hyperoxic cardiopulmonary bypass', 'normoxic management', 'normoxic cardiopulmonary bypass', 'cardiopulmonary bypass', 'Normoxic cardiopulmonary bypass']","['myocardial total oxidant status', 'myocardial oxidative stress', 'myocardial total antioxidant status and length of intensive care unit and hospital stay', 'Myocardial total oxidant status']","[{'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0242706', 'cui_str': 'Hyperoxia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085403', 'cui_str': 'Oxidizing Agents'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",48.0,0.0305002,"There was no statistically significant difference regarding myocardial total antioxidant status and length of intensive care unit and hospital stay (p = 0.08, p = 0.82, and p = 0.54, respectively). ","[{'ForeName': 'Ahmet Can', 'Initials': 'AC', 'LastName': 'Topcu', 'Affiliation': 'Department of Cardiovascular Surgery, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Bolukcu', 'Affiliation': 'Department of Cardiovascular Surgery, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Kamile', 'Initials': 'K', 'LastName': 'Ozeren', 'Affiliation': 'Department of Cardiovascular Surgery, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Tugba', 'Initials': 'T', 'LastName': 'Kavasoglu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ilyas', 'Initials': 'I', 'LastName': 'Kayacioglu', 'Affiliation': 'Department of Cardiovascular Surgery, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}]",Perfusion,['10.1177/0267659120946733'] 1192,32768259,No Differences in Midterm Sports Participation or Functional Scores After Total Hip Arthroplasty by Posterolateral Vs Anterolateral Approach.,"BACKGROUND Patients undergoing total hip arthroplasty (THA) frequently question surgeons on return to sports. We compared midterm sports participation and functional scores after THA by posterolateral approach (PLA) vs anterolateral approach (ALA). METHODS Of 1381 patients who underwent uncemented ceramic-on-ceramic THA for primary osteoarthritis, 503 were excluded because of preoperative or postoperative lower limb surgery, leaving 594 operated by PLA and 284 by ALA. Forgotten Joint Score (FJS), Oxford Hip Score (OHS), satisfaction, as well as motivation, participation, and discomfort regarding 22 sports were collected. A 1:1 matching was performed to obtain 2 groups of PLA and ALA patients with similar age, gender, body mass index, and sports motivation. RESULTS Matching yielded 2 equal groups of 259 patients. There were no significant differences in FJS (P = .057), OHS (P = .685), satisfaction (P = .369), or rates of participation in light (P = .999), moderate (P = .632), or strenuous sports (P = .284). Participation in strenuous sports was reported by 50 PLA (19%) and 61 ALA (24%) patients, with differences for downhill skiing (22 vs 39), running (10 vs 19), and cross-country skiing (18 vs 10). More than 50% of motivated patients practiced most of their sports. Severe discomfort was reported similarly in PLA and ALA patients, mainly during running (13 vs 11), team ball games (9 vs 7), and downhill skiing (7 vs 8). CONCLUSION There were no significant differences between PLA and ALA patients in terms of OHS, FJS, satisfaction, or sports participation rates. There is little or no evidence to promote an approach based on sports participation or functional improvement. LEVEL OF EVIDENCE Level III, comparative study.",2020,"There were no significant differences between PLA and ALA patients in terms of OHS, FJS, satisfaction, or sports participation rates.","['1381 patients who underwent uncemented ceramic-on-ceramic THA for primary osteoarthritis, 503 were excluded because of preoperative or postoperative lower limb surgery, leaving 594 operated by PLA and 284 by ALA', 'Patients undergoing total hip arthroplasty (THA) frequently question surgeons on return to sports']",['THA by posterolateral approach (PLA) vs anterolateral approach (ALA'],"['Severe discomfort', 'rates of participation in light', 'Midterm Sports Participation or Functional Scores', 'Forgotten Joint Score (FJS), Oxford Hip Score (OHS), satisfaction, as well as motivation, participation, and discomfort regarding 22 sports', 'satisfaction', 'OHS, FJS, satisfaction, or sports participation rates', 'OHS', 'FJS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0409952', 'cui_str': 'Idiopathic osteoarthritis'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0587271', 'cui_str': 'Posterolateral approach'}, {'cui': 'C0332194', 'cui_str': 'Anterolateral'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}]","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0587271', 'cui_str': 'Posterolateral approach'}, {'cui': 'C0332194', 'cui_str': 'Anterolateral'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4759288', 'cui_str': 'Forgotten Joint Score'}, {'cui': 'C1998079', 'cui_str': 'Oxford hip score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",22.0,0.0427256,"There were no significant differences between PLA and ALA patients in terms of OHS, FJS, satisfaction, or sports participation rates.","[{'ForeName': 'Michel P', 'Initials': 'MP', 'LastName': 'Bonnin', 'Affiliation': 'Hôpital Privé Jean Mermoz, Centre Orthopédique Santy, Ramsay Santé, Lyon, France; Artro Institute, Lyon, France.'}, {'ForeName': 'Michel-Henri', 'Initials': 'MH', 'LastName': 'Fessy', 'Affiliation': 'Artro Institute, Lyon, France; Department of Orthopaedic Surgery and Sports Medicine, Centre Hospitalier Lyon-Sud, Pierre-Bénite, France.'}, {'ForeName': 'Floris', 'Initials': 'F', 'LastName': 'Van Rooij', 'Affiliation': 'ReSurg SA, Nyon, Switzerland.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Nover', 'Affiliation': 'ReSurg SA, Nyon, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Tarik', 'Initials': 'T', 'LastName': 'Ait-Si-Selmi', 'Affiliation': 'Hôpital Privé Jean Mermoz, Centre Orthopédique Santy, Ramsay Santé, Lyon, France; Artro Institute, Lyon, France.'}]",The Journal of arthroplasty,['10.1016/j.arth.2020.07.009'] 1193,32769842,Lipid Analysis on Block Copolymer-containing Packaging Solution and Lens Care Regimens: A Randomized Clinical Trial.,"SIGNIFICANCE Lotrafilcon B lenses packaged in and cared for with block copolymer-containing (polyoxyethylene-polyoxybutylene; EOBO) lens care solutions resulted in lower cholesterol extraction than each of the habitual silicone hydrogel lens/multipurpose solution (MPS) regimens tested. PURPOSE This study aimed to compare the extracted cholesterol of lotrafilcon B lenses packaged in and cared for with EOBO-containing lens care solutions with the extracted cholesterol of habitual silicone hydrogel lenses cared for with MPS not containing EOBO. METHODS In this prospective, randomized, observer-masked parallel study, habitual wearers of senofilcon C, senofilcon A, comfilcon A, and samfilcon A contact lenses using a non-EOBO MPS were randomized 1:1 to lotrafilcon B lenses packaged in and cared for with EOBO-containing solutions or to their habitual lenses and MPS. Subjects randomized to lotrafilcon B were further randomized to one of two EOBO-containing lens care solutions, OPTI-FREE PUREMOIST or CLEAR CARE PLUS with HydraGlyde (Alcon Laboratories, Inc., Fort Worth, TX). A subset of right eye lenses was collected after wear, and total cholesterol was extracted and measured using a fluorometric enzymatic assay. RESULTS Of 143 lenses analyzed, 95 were from subjects randomized to their habitual lenses/MPS and 48 to lotrafilcon B + EOBO lenses plus CLEAR CARE PLUS with HydraGlyde or OPTI-FREE PUREMOIST. The mean amounts of cholesterol extracted from lotrafilcon B + EOBO lenses cared for with CLEAR CARE PLUS with HydraGlyde (0.28 ± 0.18 μg/lens) and OPTI-FREE PUREMOIST (0.28 ± 0.48 μg/lens) were significantly lower than those extracted from senofilcon C (4.18 ± 3.25 μg/lens), senofilcon A (2.19 ± 2.69 μg/lens), comfilcon A (2.17 ± 1.47 μg/lens), and samfilcon A (2.07 ± 1.48 μg/lens) lenses used with MPS (P < .0001 each). CONCLUSIONS Cholesterol sorption was significantly lower in wearers of lotrafilcon B lenses cared for with polyoxyethylene-polyoxybutylene-containing lens care solutions than in users of habitual silicone hydrogel lenses cared for with non-polyoxyethylene-polyoxybutylene MPS.",2020,"CONCLUSIONS Cholesterol sorption was significantly lower in wearers of lotrafilcon B lenses cared for with polyoxyethylene-polyoxybutylene-containing lens care solutions than in users of habitual silicone hydrogel lenses cared for with non-polyoxyethylene-polyoxybutylene MPS.","['habitual silicone hydrogel lenses cared for with MPS not containing EOBO', 'Of 143 lenses analyzed', 'habitual wearers of senofilcon C, senofilcon A, comfilcon A, and samfilcon A contact lenses using a non-EOBO MPS']","['polyoxyethylene-polyoxybutylene-containing lens care solutions', 'lotrafilcon B lenses packaged in and cared for with EOBO-containing solutions or to their habitual lenses and MPS', 'EOBO-containing lens care solutions, OPTI-FREE PUREMOIST or CLEAR CARE PLUS with HydraGlyde', 'habitual lenses/MPS and 48 to lotrafilcon B + EOBO lenses plus CLEAR CARE PLUS with HydraGlyde or OPTI-FREE']",[],"[{'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C2002497', 'cui_str': 'senofilcon A'}, {'cui': 'C2715682', 'cui_str': 'comfilcon A'}, {'cui': 'C0009836', 'cui_str': 'Contact lenses'}]","[{'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C2001571', 'cui_str': 'lotrafilcon B'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}]",[],,0.0694105,"CONCLUSIONS Cholesterol sorption was significantly lower in wearers of lotrafilcon B lenses cared for with polyoxyethylene-polyoxybutylene-containing lens care solutions than in users of habitual silicone hydrogel lenses cared for with non-polyoxyethylene-polyoxybutylene MPS.","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Shows', 'Affiliation': 'Alcon Research, LLC, Fort Worth, Texas.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Redfern', 'Affiliation': 'College of Optometry, University of Houston, Houston, Texas.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Sickenberger', 'Affiliation': 'Jenvis Research, Ernst-Abbe University of Applied Sciences, Jena, Germany.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Fogt', 'Affiliation': 'The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Schulze', 'Affiliation': 'University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lievens', 'Affiliation': 'Southern College of Optometry, Memphis, Tennessee.'}, {'ForeName': 'Loretta', 'Initials': 'L', 'LastName': 'Szczotka-Flynn', 'Affiliation': 'University Hospitals of Cleveland Eye Institute, Cleveland, Ohio.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schwarz', 'Affiliation': 'Private Practice, Hildesheim, Germany.'}, {'ForeName': 'Anna A', 'Initials': 'AA', 'LastName': 'Tichenor', 'Affiliation': 'Indiana University, Bloomington, Indiana.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Marx', 'Affiliation': 'Jenvis Research, Ernst-Abbe University of Applied Sciences, Jena, Germany.'}, {'ForeName': 'Jessie M', 'Initials': 'JM', 'LastName': 'Lemp-Hull', 'Affiliation': 'Alcon Research, LLC, Fort Worth, Texas.'}]",Optometry and vision science : official publication of the American Academy of Optometry,['10.1097/OPX.0000000000001553'] 1194,32771996,Influence of Valve Type and Antiplatelet Regimen on Platelet Reactivity After TAVI: Subanalysis of the REAC-TAVI Trial.,"OBJECTIVES Ticagrelor has proven more effective than clopidogrel at attaining a maintained suppression of high platelet reactivity (HPR) in aortic stenosis patients undergoing transcatheter aortic valve implantation (TAVI). This study aims to assess the influence of implanted valve type on the degree of platelet reactivity (PR) after TAVI. METHODS This study is a prespecified analysis of REAC-TAVI, a prospective, multicenter study that included patients on dual-antiplatelet therapy with aspirin and clopidogrel before TAVI. Patients with HPR (n = 48) were randomized to aspirin and clopidogrel or aspirin and ticagrelor for 3 months, while those without HPR (n = 20) were continued on aspirin and clopidogrel. PR was measured 6 hours, 24 hours, 5 days, 30 days, and 90 days after TAVI with VerifyNow assay. Bioprosthetic valves were classified as balloon-expandable valve (BEV), self-expandable valve (SEV), or other. RESULTS Sixty-eight patients comprising 32 BEVs, 28 SEVs, and 8 other valves were included. Devices were larger and postdilation was more frequent in the SEV group. Follow-up PR was lower in patients treated with ticagrelor vs those treated with clopidogrel at all time points after TAVI, including patients without baseline HPR (P<.001). PR after TAVI was similar in the three groups. Major cardiovascular adverse events, stroke, and hemorrhagic complications were comparable across the different bioprosthesis groups at 4-month follow-up. CONCLUSIONS The effect of valve type on PR after TAVI is similar across the spectrum of most transcatheter valves. In our sample, ticagrelor achieved a faster and more effective reduction in PR than clopidogrel in patients with HPR undergoing TAVI, irrespective of valve type.",2020,"Follow-up PR was lower in patients treated with ticagrelor vs those treated with clopidogrel at all time points after TAVI, including patients without baseline HPR (P<.001).","['included patients on dual-antiplatelet therapy with aspirin and clopidogrel before TAVI', 'patients with HPR undergoing TAVI, irrespective of valve type', 'Sixty-eight patients comprising 32 BEVs, 28 SEVs, and 8 other valves were included', 'Patients with HPR (n = 48', 'aortic stenosis patients undergoing transcatheter aortic valve implantation (TAVI']","['Ticagrelor', 'aspirin and clopidogrel or aspirin and ticagrelor', 'aspirin and clopidogrel', 'TAVI', 'clopidogrel', 'ticagrelor']","['platelet reactivity (PR', 'Platelet Reactivity', 'Major cardiovascular adverse events, stroke, and hemorrhagic complications']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}]","[{'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",48.0,0.0342596,"Follow-up PR was lower in patients treated with ticagrelor vs those treated with clopidogrel at all time points after TAVI, including patients without baseline HPR (P<.001).","[{'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Trejo-Velasco', 'Affiliation': ''}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Cruz-González', 'Affiliation': ''}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Tello-Montoliu', 'Affiliation': ''}, {'ForeName': 'Jose Antonio', 'Initials': 'JA', 'LastName': 'Baz-Alonso', 'Affiliation': ''}, {'ForeName': 'Pablo Juan', 'Initials': 'PJ', 'LastName': 'Salvadores', 'Affiliation': ''}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Moreno', 'Affiliation': ''}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Romaguera', 'Affiliation': ''}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Molina-Navarro', 'Affiliation': ''}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Paredes-Galán', 'Affiliation': ''}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'De-Miguel-Castro', 'Affiliation': ''}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Bastos-Fernandez', 'Affiliation': ''}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Ortiz-Saez', 'Affiliation': ''}, {'ForeName': 'Saleta', 'Initials': 'S', 'LastName': 'Fernández-Barbeira', 'Affiliation': ''}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Iñiguez-Romo', 'Affiliation': ''}, {'ForeName': 'Victor Alfonso', 'Initials': 'VA', 'LastName': 'Jimenez-Diaz', 'Affiliation': 'Cardiovascular Research Unit & Cardiology Department, Hospital Álvaro Cunqueiro, University Hospital of Vigo, Estrada de Clara Campoamor, 341, 36312, Vigo, Spain. sooner_79@hotmail.com or victor.alfonso.jimenez.diaz@sergas.es.'}]",The Journal of invasive cardiology,[] 1195,32778876,Effect of Aspirin on Cancer Incidence and Mortality in Older Adults.,"BACKGROUND ASPirin in Reducing Events in the Elderly, a randomized, double-blind, placebo-controlled trial of daily low-dose aspirin (100 mg) in older adults, showed an increase in all-cause mortality, primarily due to cancer. In contrast, prior randomized controlled trials, mainly involving younger individuals, demonstrated a delayed cancer benefit with aspirin. We now report a detailed analysis of cancer incidence and mortality. METHODS 19 114 Australian and US community-dwelling participants aged 70 years and older (US minorities 65 years and older) without cardiovascular disease, dementia, or physical disability were randomly assigned and followed for a median of 4.7 years. Fatal and nonfatal cancer events, a prespecified secondary endpoint, were adjudicated based on clinical records. RESULTS 981 cancer events occurred in the aspirin and 952 in the placebo groups. There was no statistically significant difference between groups for all incident cancers (hazard ratio [HR] = 1.04, 95% confidence interval [CI] = 0.95 to 1.14), hematological cancer (HR = 0.98, 95% CI = 0.73 to 1.30), or all solid cancers (HR = 1.05, 95% CI = 0.95 to 1.15), including by specific tumor type. However, aspirin was associated with an increased risk of incident cancer that had metastasized (HR = 1.19, 95% CI = 1.00 to 1.43) or was stage 4 at diagnosis (HR = 1.22, 95% CI = 1.02 to 1.45), and with higher risk of death for cancers that presented at stages 3 (HR = 2.11, 95% CI = 1.03 to 4.33) or 4 (HR = 1.31, 95% CI = 1.04 to 1.64). CONCLUSIONS In older adults, aspirin treatment had an adverse effect on later stages of cancer evolution. These findings suggest that in older persons, aspirin may accelerate the progression of cancer and, thus, suggest caution with its use in this age group.",2021,"However, aspirin was associated with an increased risk of incident cancer that had metastasized (HR = 1.19, 95% CI = 1.00 to 1.43) or was stage 4 at diagnosis (HR = 1.22, 95% CI = 1.02 to 1.45), and with higher risk of death for cancers that presented at stages 3 (HR = 2.11, 95% CI = 1.03 to 4.33) or 4 (HR = 1.31, 95% CI = 1.04 to 1.64). ","['older persons', '19,114 Australian and U.S. community-dwelling participants aged 70+ years (U.S. minorities 65+ years) without cardiovascular disease, dementia or physical disability were randomized and followed for a median of 4.7 years', 'older adults']","['ASPirin', 'aspirin', 'placebo']","['cancer incidence and mortality', 'adverse effect on later stages of cancer evolution', 'risk of incident cancer', 'hematological cancer']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",19114.0,0.510099,"However, aspirin was associated with an increased risk of incident cancer that had metastasized (HR = 1.19, 95% CI = 1.00 to 1.43) or was stage 4 at diagnosis (HR = 1.22, 95% CI = 1.02 to 1.45), and with higher risk of death for cancers that presented at stages 3 (HR = 2.11, 95% CI = 1.03 to 4.33) or 4 (HR = 1.31, 95% CI = 1.04 to 1.64). ","[{'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gibbs', 'Affiliation': 'The Walter & Eliza Hall Institute of Medical Research, Melbourne, Victoria, Australia; and Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Suzanne G', 'Initials': 'SG', 'LastName': 'Orchard', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Lockery', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Wendy B', 'Initials': 'WB', 'LastName': 'Bernstein', 'Affiliation': 'Walter Reed National Military Medical Center, Bethesda, MD, USA.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Ford', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Haydon', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Kirpach', 'Affiliation': 'Berman Center for Outcomes and Clinical Research, Hennepin Health Research Institute, Hennepin, HealthCare, Minneapolis, MN, USA.'}, {'ForeName': 'Finlay', 'Initials': 'F', 'LastName': 'Macrae', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia; and Department of Colorectal Medicine and Genetics, The Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'McLean', 'Affiliation': 'Department of Anatomical Pathology, Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Millar', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Murray', 'Affiliation': 'Berman Center for Outcomes and Clinical Research, Hennepin Health Research Institute, Hennepin, HealthCare, Minneapolis, MN, USA.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Polekhina', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Richmond', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA.'}, {'ForeName': 'Luz Maria', 'Initials': 'LM', 'LastName': 'Rodríguez', 'Affiliation': 'Walter Reed National Military Medical Center, Bethesda, MD, USA.'}, {'ForeName': 'Raj C', 'Initials': 'RC', 'LastName': 'Shah', 'Affiliation': ""Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago, IL, USA.""}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Tie', 'Affiliation': 'The Walter & Eliza Hall Institute of Medical Research, Melbourne, Victoria, Australia; and Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Asad', 'Initials': 'A', 'LastName': 'Umar', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA.'}, {'ForeName': 'G J van', 'Initials': 'GJV', 'LastName': 'Londen', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Kathlyn', 'Initials': 'K', 'LastName': 'Ronaldson', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Woods', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Zalcberg', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Chan', 'Affiliation': 'Clinical and Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the National Cancer Institute,['10.1093/jnci/djaa114'] 1196,32788412,Efficacy of an 8-Week Resistance Training Program in Older Adults: A Randomized Controlled Trial.,"Older adults are challenged with aging-related declines in skeletal muscle mass and function. Although exercise interventions of longer duration typically yield larger changes, shorter-term interventions may kick-start positive effects, allowing participants to begin engaging in more activity. This study aimed to determine whether 8 weeks of a resistance training program (Stay Strong, Stay Healthy [SSSH]) improved dynamic muscle strength, balance, flexibility, and sleep. Inactive adults aged ≥60 years were randomized into SSSH (n = 15), walking (WALK; n = 17), or control (CON; n = 14) groups. The SSSH and WALK groups met 2 times per week for 60 min. The participants completed pre/post general health, activity, and sleep questionnaires; DXA scans; and functional tasks. One-way repeated-measures multivariate analysis of variance was used to determine interactions and decomposed using repeated-measures analysis of variance. SSSH improved sit-to-stand performance, back scratch distance, and sleep quality and reported more auxiliary physical activity than WALK or CON (p < .05). Resistance training interventions in sedentary older adults can improve physical function and encourage additional activity in 8 weeks.",2020,"SSSH improved sit-to-stand performance, back scratch distance, and sleep quality and reported more auxiliary physical activity than WALK or CON (p < .05).","['sedentary older adults', 'Inactive adults aged ≥60\xa0years', 'Older Adults', 'Older adults']","['8-Week Resistance Training Program', 'resistance training program (Stay Strong, Stay Healthy [SSSH', 'SSSH', 'Resistance training interventions']","['dynamic muscle strength, balance, flexibility, and sleep', 'auxiliary physical activity', 'general health, activity, and sleep questionnaires; DXA scans; and functional tasks', 'SSSH improved sit-to-stand performance, back scratch distance, and sleep quality']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0311213', 'cui_str': 'Dermatitis verrucosa'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",,0.0468909,"SSSH improved sit-to-stand performance, back scratch distance, and sleep quality and reported more auxiliary physical activity than WALK or CON (p < .05).","[{'ForeName': 'Breanne S', 'Initials': 'BS', 'LastName': 'Baker', 'Affiliation': ''}, {'ForeName': 'Kelsey J', 'Initials': 'KJ', 'LastName': 'Weitzel', 'Affiliation': ''}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Royse', 'Affiliation': ''}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Miller', 'Affiliation': ''}, {'ForeName': 'Trent M', 'Initials': 'TM', 'LastName': 'Guess', 'Affiliation': ''}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Ball', 'Affiliation': ''}, {'ForeName': 'Dana L', 'Initials': 'DL', 'LastName': 'Duren', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2020-0078'] 1197,32788532,Availability Bias Causes Misdiagnoses by Physicians: Direct Evidence from a Randomized Controlled Trial.,"Objective Empirical evidence on the availability bias associated with diagnostic errors is still insufficient. We investigated whether or not recent experience with clinical problems can lead physicians to make diagnostic errors due to availability bias and whether or not reflection counteracts this bias. Methods Forty-six internal medicine residents were randomly divided into a control group (CG) and experimental group (EG). Among the eight clinical cases used in this study, three experimental cases were similar to the disease of dengue fever (DF) but exhibited different diagnoses, one was actually DF, and the other four filler cases were not associated with DF. First, only the EG received information on DF, while the CG knew nothing about this study. Then, six hours later, all participants were asked to diagnose eight clinical cases via nonanalytic reasoning. Finally, four cases were diagnosed again via reflective reasoning. Results In stage 2, the average score of the CG in the diagnosis of experimental cases was significantly higher than that of the filler cases (0.80 vs. 0.59, p<0.01), but the EG's average score in the two types of cases was not significantly different (0.66 vs. 0.64, p=0.756). The EG and CG had significantly different scores for each experimental case, while no difference was observed in the filler cases. The proportion of diseases incorrectly diagnosed as DF among experimental cases ranged from 71% to 100% in the EG. There were no significant differences between the mean diagnostic accuracy scores obtained by nonanalytic reasoning and those obtained by the reflective reasoning in any cases. Conclusion Availability bias led to diagnostic errors. Misdiagnoses cannot always be repaired solely by adopting a reflective approach.",2020,There were no significant differences between the mean diagnostic accuracy scores obtained by nonanalytic reasoning and those obtained by the reflective reasoning in any cases.,['Methods Forty-six internal medicine residents'],['control group (CG) and experimental group (EG'],"['disease of dengue fever (DF', 'mean diagnostic accuracy scores']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011311', 'cui_str': 'Dengue'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",46.0,0.0193901,There were no significant differences between the mean diagnostic accuracy scores obtained by nonanalytic reasoning and those obtained by the reflective reasoning in any cases.,"[{'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'School of Public Health & Management, Wenzhou Medical University, P.R China.'}, {'ForeName': 'Zi Yan', 'Initials': 'ZY', 'LastName': 'Cheng', 'Affiliation': 'School of Public Health & Management, Wenzhou Medical University, P.R China.'}, {'ForeName': 'Gui Lin', 'Initials': 'GL', 'LastName': 'Liu', 'Affiliation': 'School of Public Health & Management, Wenzhou Medical University, P.R China.'}]","Internal medicine (Tokyo, Japan)",['10.2169/internalmedicine.4664-20'] 1198,32737420,Cardiac biomarkers in patients with prostate cancer and cardiovascular disease receiving gonadotrophin releasing hormone agonist vs antagonist.,"BACKGROUND Gonadotrophin releasing hormone (GnRH) agonists and antagonists reduce testosterone levels for the treatment of advanced and metastatic prostate cancer. Androgen deprivation therapy (ADT) is associated with increased risk of cardiovascular (CV) events and CV disease (CVD), especially in patients with preexisting CVD treated with GnRH agonists. Here, we investigated the potential relationship between serum levels of the cardiac biomarkers N-terminal pro-B-type natriuretic peptide (NTproBNP), D-dimer, C-reactive protein (CRP), and high-sensitivity troponin (hsTn) and the risk of new CV events in prostate cancer patients with a history of CVD receiving a GnRH agonist or antagonist. METHODS Post-hoc analyses were performed of a phase II randomized study that prospectively assessed CV events in patients with prostate cancer and preexisting CVD, receiving GnRH agonist or antagonist. Cox proportional hazards models were used to determine whether the selected biomarkers had any predictive effect on CV events at baseline and across a 12-month treatment period. RESULTS Baseline and disease characteristics of the 80 patients who took part in the study were well balanced between treatment arms. Ischemic heart disease (66%) and myocardial infarction (37%) were the most common prior CVD and the majority (92%) of patients received CV medication. We found that high levels of NTproBNP (p = 0.008), and hsTn (p = 0.004) at baseline were associated with the development of new CV events in the GnRH agonist group but not in the antagonist. In addition, a nonsignificant trend was observed between higher levels of NTproBNP over time and the development of new CV events in the GnRH agonist group. CONCLUSIONS The use of cardiac biomarkers may be worthy of further study as tools in the prediction of CV risk in prostate cancer patients receiving ADT. Analysis was limited by the small sample size; larger studies are required to validate biomarker use to predict CV events among patients receiving ADT.",2021,"We found that high levels of NTproBNP (p = 0.008), and hsTn (p = 0.004) at baseline were associated with the development of new CV events in the GnRH agonist group but not in the antagonist.","['patients with prostate cancer and preexisting CVD, receiving', 'advanced and metastatic prostate cancer', 'prostate cancer patients with a history of CVD receiving a GnRH agonist or antagonist', 'prostate cancer patients receiving ADT', 'patients with preexisting CVD treated with GnRH agonists', 'patients with prostate cancer and cardiovascular disease receiving', 'patients receiving ADT']","['GnRH agonist or antagonist', 'gonadotrophin releasing hormone agonist vs antagonist', 'Gonadotrophin releasing hormone (GnRH) agonists and antagonists', 'Androgen deprivation therapy (ADT']","['Ischemic heart disease', 'higher levels of NTproBNP over time and the development of new CV events', 'new CV events', 'myocardial infarction', 'testosterone levels', 'serum levels of the cardiac biomarkers N-terminal pro-B-type natriuretic peptide (NTproBNP), D-dimer, C-reactive protein (CRP), and high-sensitivity troponin (hsTn', 'CV events', 'risk of cardiovascular (CV) events and CV disease (CVD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0936223', 'cui_str': 'Prostate cancer metastatic'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}]","[{'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.0970567,"We found that high levels of NTproBNP (p = 0.008), and hsTn (p = 0.004) at baseline were associated with the development of new CV events in the GnRH agonist group but not in the antagonist.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Margel', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petach Tikva, Israel. sdmargel@gmail.com.'}, {'ForeName': 'Yaara', 'Initials': 'Y', 'LastName': 'Ber', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petach Tikva, Israel.'}, {'ForeName': 'Avivit', 'Initials': 'A', 'LastName': 'Peer', 'Affiliation': 'Department of Oncology, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Liat', 'Initials': 'L', 'LastName': 'Shavit-Grievink', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petach Tikva, Israel.'}, {'ForeName': 'Jehonathan H', 'Initials': 'JH', 'LastName': 'Pinthus', 'Affiliation': 'Department of Surgery, Division of Urology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Witberg', 'Affiliation': 'Department of Cardiology, Rabin Medical Center, Petach Tikva, Israel.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Baniel', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petach Tikva, Israel.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Kedar', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petach Tikva, Israel.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Rosenbaum', 'Affiliation': 'Davidoff Cancer Centre, Rabin Medical Center, Petach Tikva, Israel.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-020-0264-9'] 1199,32739494,Cancer history and risk factors in healthy older people enrolling in the ASPREE clinical trial.,"BACKGROUND Cancer is a leading cause of death globally. Given the elevated risk of cancer with age and an ageing population, it is important to understand the changing burden of cancer in older populations. The ASPirin in Reducing Events in the Elderly (ASPREE) study randomised healthy older individuals to 100 mg aspirin or placebo, with clinical outcomes and disability-free survival endpoints. Detailed baseline data provides a rare opportunity to explore cancer burden in a uniquely healthy older population. METHODS At study enrolment (2010-2014), self-reported personal cancer history, cancer type and cancer risk factor data were sought from 19,114 participants (Australia, n = 16,703; U.S., n = 2411). Eligible participants were healthy, free of major diseases and expected to survive 5 years. RESULTS Nearly 20% of enrolling ASPREE participants reported a prior cancer diagnosis; 18% of women and 22% of men, with women diagnosed younger (16% vs 6% of diagnoses <50 years). Cancer prevalence increased with age. Prevalence of prostate and breast cancer history were higher in U.S. participants; melanoma and colorectal cancer were higher in Australian participants. Cancer history prevalence was not associated with contemporary common risk factors nor previous aspirin use, but was associated with poor health ratings in men. Blood and breast cancer history were more common with past aspirin use. CONCLUSIONS Personal cancer history in healthy older ASPREE participants was as expected for the most common cancer types in the respective populations, but was not necessarily aligned with known risk factors. We attribute this to survivor bias, likely driven by entry criteria. TRIAL REGISTRATION International Standard Randomised Controlled Trial Number Register (ISRCTN83772183) and clinicaltrials.gov (NCT01038583).",2020,Prevalence of prostate and breast cancer history were higher in U.S. participants; melanoma and colorectal cancer were higher in Australian participants.,"['healthy older individuals to 100\u202fmg', 'Eligible participants were healthy, free of major diseases and expected to survive 5\u202fyears', 'healthy older ASPREE participants', 'healthy older people enrolling', 'At study enrolment (2010-2014), self-reported personal cancer history, cancer type and cancer risk factor data were sought from 19,114 participants (Australia, n\u202f=\u202f16,703; U.S., n\u202f=\u202f2411', 'uniquely healthy older population']","['ASPirin', 'aspirin or placebo']","['Cancer history and risk factors', 'Prevalence of prostate and breast cancer history', 'Cancer prevalence']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]",19114.0,0.463069,Prevalence of prostate and breast cancer history were higher in U.S. participants; melanoma and colorectal cancer were higher in Australian participants.,"[{'ForeName': 'Suzanne G', 'Initials': 'SG', 'LastName': 'Orchard', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: Suzanne.orchard@monash.edu.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Lockery', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: Jessica.lockery@monash.edu.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gibbs', 'Affiliation': 'The Walter & Eliza Hall Institute of Medical Research, University of Melbourne,1G Royal Parade, Parkville, Victoria 3052, Australia. Electronic address: Peter.gibbs@petermac.org.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Polekhina', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: Galhina.polekhina@monash.edu.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: Rory.wolfe@monash.edu.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Zalcberg', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: John.zalcberg@monash.edu.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Haydon', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: Andrew.haydon@monash.edu.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: John.mcneil@monash.edu.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, 17 Liverpool St (Private Bag 23), Hobart 7000, Tasmania, Australia. Electronic address: Mark.nelson@utas.edu.au.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'School of Public Health, Curtin University, Kent Street, Bentley, Perth 6102, Western Australia, Australia. Electronic address: Christpher.reid@curtin.edu.au.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Kirpach', 'Affiliation': 'Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute (HHRI), 701 Park Avenue, Suite PP7.700, Minneapolis 55415, Minnesota, USA. Electronic address: bkirpach@bermancenter.org.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Murray', 'Affiliation': 'Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute (HHRI), 701 Park Avenue, Suite PP7.700, Minneapolis 55415, Minnesota, USA; Division of Geriatrics, Department of Medicine, Hennepin Healthcare and University of Minnesota, East River Parkway, Minneapolis 55455, Minnesota, USA. Electronic address: AMurray@bermancenter.org.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Woods', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: Robyn.woods@monash.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.106095'] 1200,32740716,Efficacy of exercise rehabilitation program accompanied by experiential music for recovery of aphasia in single cerebrovascular accidents: a randomized controlled trial.,"BACKGROUND The current study aims to evaluate the effects of daily traditional experiential music listening for clinical recovery of post-stroke aphasia. METHODS This was a prospective randomized trial with seventy-nine stroke survivors who suffered from post-stroke aphasia. All patients underwent a neuropsychological evaluation, at time = 0 during the admission at the rehabilitation structure (baseline), and 6 months post-stroke. All cases received standard treatment for stroke and post-stroke aphasia in terms of medical care and rehabilitation. Furthermore, patients were randomized to receive either standard care only or standard care with daily traditional experiential music listening. Computer tomography perfusion and neurological examination were assessed to all patients. Recovery was measured by the score at Aachener Aphasie Test. RESULTS The statistically significant differences between the control group (CG) and the rest of the patients were the clinical characteristics (hemiparesis) (p = 0.002), the cerebral blood flow in affected areas (p = 0.000), and the Mini-Mental Test (mMT) (p = 0.000). Only group and mMT were independent predictor factors for recovery, according to multivariate analysis odd ratio (ΟR) (95% confidence interval) 0.022 (0.009-0.435) and 0.658 (0.142-0.224) respectively. CONCLUSIONS The results of this study are promising and suggest that an enriched sound environment is beneficial for patients with post-stroke aphasia since the recovery rate is higher when standard care was combined with daily music listening.",2021,"Only group and mMT were independent predictor factors for recovery, according to multivariate analysis odd ratio (ΟR) (95% confidence interval) 0.022 (0.009-0.435) and 0.658 (0.142-0.224) respectively. ","['single cerebrovascular accidents', 'seventy-nine stroke survivors who suffered from post-stroke aphasia']","['exercise rehabilitation program accompanied by experiential music', 'daily traditional experiential music listening', 'standard care only or standard care with daily traditional experiential music listening']","['cerebral blood flow', 'Mini-Mental Test (mMT', 'Computer tomography perfusion and neurological examination', 'clinical characteristics (hemiparesis']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}]","[{'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0025365', 'cui_str': 'Mental Tests'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0018989', 'cui_str': 'Hemiparesis'}]",,0.230267,"Only group and mMT were independent predictor factors for recovery, according to multivariate analysis odd ratio (ΟR) (95% confidence interval) 0.022 (0.009-0.435) and 0.658 (0.142-0.224) respectively. ","[{'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Aravantinou-Fatorou', 'Affiliation': 'First Department of Medicine, Laiko General Hospital, Athens, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Fotakopoulos', 'Affiliation': ""Department of Neurosurgery, General Hospital of Pyrgos 'Andreas Papandreou', Sintriada, 27100, Pyrgos Ilias, Greece. gfotakop@yahoo.gr.""}]",Irish journal of medical science,['10.1007/s11845-020-02328-x'] 1201,32749918,"Acute Effects of Turmeric Extracts on Knee Joint Pain: A Pilot, Randomized Controlled Trial.","Turmeric extracts (TEs) have been shown to be suitable as a pain treatment for human joint arthritis. In a pilot, randomized clinical trial, 68 individuals with mild/moderate knee joint pain (KJP) consumed a new formulation of water-soluble TEs and insoluble curcuminoids (B-Turmactive ® ) or brewer's yeast as a placebo for 1 week. Our hypothesis was that B-Turmactive would have a short-term analgesic effect on KJP measured by the self-reported Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). After 3 days and 1 week, both treatments reduced pain when walking on a flat surface ( P  < .01), going up or down stairs ( P  < .001), and sitting or lying ( P  < .05), but only B-Turmactive reduced pain at night while in bed and in an upright standing position ( P  < .01). Concerning global KJP, it was reduced by both treatments after 3 days and 1 week of the intervention ( P  < .001), being less with B-Turmactive after 1 week ( P  = .012 vs. 3 weeks). Although no intertreatment differences were observed, only B-Turmactive decreased high-sensitivity C-reactive protein levels ( P  = .045) at 1 week, which indicates a prompt analgesic effect mediated by a decrease in inflammatory status.",2021,"After 3 days and 1 week, both treatments reduced pain when walking on a flat surface ( P  < .01), going up or down stairs ( P  < .001), and sitting or lying ( P  < .05), but only B-Turmactive reduced pain at night while in bed and in an upright standing position ( P  < .01).",['68 individuals with mild/moderate knee joint pain (KJP'],"['Turmeric extracts (TEs', ""new formulation of water-soluble TEs and insoluble curcuminoids (B-Turmactive ® ) or brewer's yeast as a placebo"", 'Turmeric Extracts']","['Knee Joint Pain', 'sensitivity C-reactive protein levels', 'inflammatory status', 'pain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}]","[{'cui': 'C0077524', 'cui_str': 'Turmeric extract'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0036025', 'cui_str': 'Saccharomyces cerevisiae'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",68.0,0.0378062,"After 3 days and 1 week, both treatments reduced pain when walking on a flat surface ( P  < .01), going up or down stairs ( P  < .001), and sitting or lying ( P  < .05), but only B-Turmactive reduced pain at night while in bed and in an upright standing position ( P  < .01).","[{'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Calderón-Pérez', 'Affiliation': 'Eurecat, Technological Center of Catalonia, Nutrition and Health Unit, Reus, Spain.'}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Llauradó', 'Affiliation': 'Eurecat, Technological Center of Catalonia, Nutrition and Health Unit, Reus, Spain.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Companys', 'Affiliation': 'Eurecat, Technological Center of Catalonia, Nutrition and Health Unit, Reus, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pla-Pagà', 'Affiliation': 'Eurecat, Technological Center of Catalonia, Nutrition and Health Unit, Reus, Spain.'}, {'ForeName': 'Noemí', 'Initials': 'N', 'LastName': 'Boqué', 'Affiliation': 'Eurecat, Technological Center of Catalonia, Nutrition and Health Unit, Reus, Spain.'}, {'ForeName': 'Francesc', 'Initials': 'F', 'LastName': 'Puiggrós', 'Affiliation': 'Eurecat, Technological Center of Catalonia, Nutrition and Health Unit, Reus, Spain.'}, {'ForeName': 'Rosa-M', 'Initials': 'RM', 'LastName': 'Valls', 'Affiliation': 'Eurecat, Technological Center of Catalonia, Nutrition and Health Unit, Reus, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Pedret', 'Affiliation': 'Eurecat, Technological Center of Catalonia, Nutrition and Health Unit, Reus, Spain.'}, {'ForeName': 'Josep Manuel', 'Initials': 'JM', 'LastName': 'Llabrés', 'Affiliation': 'PLAMECA S.A. (Medicinal Plants and Food Supplements, S.A.), Barcelona, Spain.'}, {'ForeName': 'Lluís', 'Initials': 'L', 'LastName': 'Arola', 'Affiliation': 'Eurecat, Technological Center of Catalonia, Nutrition and Health Unit, Reus, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Solà', 'Affiliation': 'Functional Nutrition, Oxidation and Cardiovascular Diseases Research Group (NFOC-Salut), Faculty of Medicine and Health Sciences, Rovira i Virgili University, Reus, Spain.'}]",Journal of medicinal food,['10.1089/jmf.2020.0074'] 1202,32755413,Preconception Blood Pressure and Its Change Into Early Pregnancy: Early Risk Factors for Preeclampsia and Gestational Hypertension.,"Preeclampsia and gestational hypertension are common complications of pregnancy associated with significant maternal and infant morbidity. Despite extensive research evaluating risk factors during pregnancy, most women who develop a hypertensive disorder of pregnancy are not considered high-risk and strategies for prevention remain elusive. We evaluated preconception blood pressure and its change into early pregnancy as novel risk markers for development of a hypertensive disorder of pregnancy. The EAGeR (Effects of Aspirin in Gestation and Reproduction) trial (2007-2011) randomized 1228 healthy women with a history of pregnancy loss to preconception-initiated low-dose aspirin versus placebo and followed participants for up to 6 menstrual cycles attempting pregnancy and throughout pregnancy if they became pregnant. Blood pressure was measured during preconception and throughout early gestation. The primary outcomes, preterm preeclampsia, term preeclampsia, and gestational hypertension, were abstracted from medical records. Among 586 women with a pregnancy >20 weeks' gestation, preconception blood pressure levels were higher for preterm preeclampsia (87.3±6.7 mm Hg mean arterial pressure), term preeclampsia (88.3±9.8 mm Hg), and gestational hypertension (87.9±9.1 mm Hg) as compared with no hypertensive disorder of pregnancy (83.9±8.6 mm Hg). Change in blood pressure from preconception into very early pregnancy was associated with development of preeclampsia (relative risk, 1.13 [95% CI, 1.02-1.25] per 2 mm Hg increase in mean arterial pressure at 4 weeks' gestation), particularly preterm preeclampsia (relative risk, 1.21 [95% CI, 1.01-1.45]). Randomization to aspirin did not alter blood pressure trajectory or risk of hypertension in pregnancy. Preconception blood pressure and longitudinal changes during early pregnancy are underexplored but crucial windows in the detection and prevention of hypertensive disorders of pregnancy. Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00467363.",2020,Randomization to aspirin did not alter blood pressure trajectory or risk of hypertension in pregnancy.,"['1228 healthy women with a history of pregnancy loss to preconception-initiated low-dose', ""586 women with a pregnancy >20 weeks' gestation, preconception blood pressure levels were higher for preterm preeclampsia (87.3±6.7 mm Hg mean arterial pressure), term preeclampsia (88.3±9.8 mm Hg), and gestational hypertension (87.9±9.1 mm Hg) as compared with no hypertensive disorder of pregnancy (83.9±8.6 mm Hg"", 'and followed participants for up to 6 menstrual cycles attempting pregnancy and throughout pregnancy if they became pregnant']","['Aspirin', 'aspirin', 'aspirin versus placebo']","['blood pressure trajectory or risk of hypertension in pregnancy', 'blood pressure', 'mean arterial pressure', 'Blood pressure', 'preterm preeclampsia', 'preterm preeclampsia, term preeclampsia, and gestational hypertension', 'Preeclampsia and gestational hypertension']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032967', 'cui_str': 'H/O: pregnancy'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0341934', 'cui_str': 'Transient hypertension of pregnancy'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0565599', 'cui_str': 'Maternal hypertension'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0341934', 'cui_str': 'Transient hypertension of pregnancy'}]",1228.0,0.253145,Randomization to aspirin did not alter blood pressure trajectory or risk of hypertension in pregnancy.,"[{'ForeName': 'Carrie J', 'Initials': 'CJ', 'LastName': 'Nobles', 'Affiliation': 'From the Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (C.J.N., P.M., S.L.M., K.K., V.C.A., M.C., L.S., N.J.P., E.F.S.).'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Mendola', 'Affiliation': 'From the Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (C.J.N., P.M., S.L.M., K.K., V.C.A., M.C., L.S., N.J.P., E.F.S.).'}, {'ForeName': 'Sunni L', 'Initials': 'SL', 'LastName': 'Mumford', 'Affiliation': 'From the Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (C.J.N., P.M., S.L.M., K.K., V.C.A., M.C., L.S., N.J.P., E.F.S.).'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': 'Obstetrics and Gynecology, School of Medicine, University of Utah (R.M.S.).'}, {'ForeName': 'Keewan', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'From the Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (C.J.N., P.M., S.L.M., K.K., V.C.A., M.C., L.S., N.J.P., E.F.S.).'}, {'ForeName': 'Victoria C', 'Initials': 'VC', 'LastName': 'Andriessen', 'Affiliation': 'From the Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (C.J.N., P.M., S.L.M., K.K., V.C.A., M.C., L.S., N.J.P., E.F.S.).'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Connell', 'Affiliation': 'From the Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (C.J.N., P.M., S.L.M., K.K., V.C.A., M.C., L.S., N.J.P., E.F.S.).'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Sjaarda', 'Affiliation': 'From the Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (C.J.N., P.M., S.L.M., K.K., V.C.A., M.C., L.S., N.J.P., E.F.S.).'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Perkins', 'Affiliation': 'From the Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (C.J.N., P.M., S.L.M., K.K., V.C.A., M.C., L.S., N.J.P., E.F.S.).'}, {'ForeName': 'Enrique F', 'Initials': 'EF', 'LastName': 'Schisterman', 'Affiliation': 'From the Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (C.J.N., P.M., S.L.M., K.K., V.C.A., M.C., L.S., N.J.P., E.F.S.).'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.14875'] 1203,32761810,Laser-assisted regenerative surgical therapy for peri-implantitis: A randomized controlled clinical trial.,"BACKGROUND Different surgical approaches have been proposed to treat peri-implantitis defects with limited effectiveness and predictability. Laser has been proposed as an effective tool to assist in bacterial decontamination and modulating peri-implant tissue inflammation. The aim of this pilot clinical trial was to evaluate the adjunctive benefits of Er:YAG laser irradiation for regenerative surgical therapy of peri-implantitis-associated osseous defects. METHODS Twenty-four patients diagnosed with peri-implantitis with a radiographic infrabony defect were randomized into two groups. Both test and control groups received the following treatment: open flap mechanical debridement, supracrestal implantoplasty, bone grafting using a mixture of human allograft with demineralized bone matrix human allograft putty, and then covered with acellular dermal matrix membrane. The only difference in the test group was the adjunctive use of Er:YAG laser to modulate and remove inflammatory tissue as well as to decontaminate the implant surface. Clinical assessments, including pocket depth (PD), clinical attachment level (CAL), and gingival index (GI) were performed by calibrated masked examiners for up to 6 months following surgery. Standardized radiographs were also taken to evaluate linear bone gain and defect bone fill. Student t-tests were used to analyze those clinical parameters. RESULTS Both groups showed significant reductions in PD, GI, and CAL gain overtime. The test group demonstrated significantly higher PD reductions at the site level compared to the control group (2.65 ± 2.14 versus 1.85 ± 1.71 mm; test versus control, P = 0.014). There were no statistical differences found in CAL gain (1.90 ± 2.28 versus 1.47 ± 1.76 mm; test versus control), GI reduction (-1.14 ± 1.15 versus -1.04 ± 0.89; test versus control), radiographic linear bone gain (1.27 ± 1.14 versus 1.08 ± 1.04 mm; test versus control) or proportional defect size reduction (- 24.46 ± 19.00% versus -15.19 ± 23.56%; test versus control). There was a positive trend for test patients on PD reduction and CAL gain found in narrow infrabony defects. Major membrane exposure negatively impaired the overall treatment outcome of CAL gain (2.47 ± 1.84 versus 1.03 ± 1.48 mm; no/minor versus major exposure, P = 0.051) and PD reduction in the test group (-3.63 ± 2.11 versus -1.66 ± 1.26 mm, P = 0.049). CONCLUSION This pilot study indicated using laser irradiation during peri-implantitis regenerative therapy may aid in better probing PD reduction. Nonetheless, a larger sample size and longer follow-up is needed to confirm if Er:YAG laser irradiation provides additional clinical benefits for peri-implantitis regenerative therapy (Clinicaltrials.gov: NCT03127228).",2021,"The test group demonstrated significantly higher PD reductions at the site level compared to the control group (2.65 ± 2.14 vs. 1.85 ± 1.71 mm; test vs. control, p = 0.014).","['Twenty-four patients diagnosed with peri-implantitis with a radiographic infrabony defect', 'peri-implantitis']","['laser irradiation', 'treatment: open flap mechanical debridement, supracrestal implantoplasty, bone grafting using a mixture of human allograft with demineralized bone matrix human allograft putty, and then covered with acellular dermal matrix membrane', 'Laser-assisted regenerative surgical therapy', 'Er:YAG laser irradiation']","['PD reduction', 'pocket depth (PD), clinical attachment level (CAL), and gingival index (GI', 'CAL gain', 'PD, GI, and CAL gain overtime', 'radiographic linear bone gain', 'PD reductions', 'linear bone gain and defect bone fill', 'PD reduction and CAL gain']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C2936258', 'cui_str': 'Dental peri-implantitis'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0005976', 'cui_str': 'Bone graft'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0005962', 'cui_str': 'Bone matrix'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C3494272', 'cui_str': 'Acellular Dermal Matrix'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0457903', 'cui_str': 'Erbium:YAG laser device'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C2961731', 'cui_str': 'Overtime'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0243067', 'cui_str': 'defects'}]",24.0,0.10956,"The test group demonstrated significantly higher PD reductions at the site level compared to the control group (2.65 ± 2.14 vs. 1.85 ± 1.71 mm; test vs. control, p = 0.014).","[{'ForeName': 'Chin-Wei', 'Initials': 'CW', 'LastName': 'Wang', 'Affiliation': 'Department of Periodontics and Oral Medicine, University of Michigan School of Dentistry, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Sajjad', 'Initials': 'S', 'LastName': 'Ashnagar', 'Affiliation': 'Private practice, Dallas, Texas, USA.'}, {'ForeName': 'Riccardo Di', 'Initials': 'RD', 'LastName': 'Gianfilippo', 'Affiliation': 'Department of Periodontics and Oral Medicine, University of Michigan School of Dentistry, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Arnett', 'Affiliation': 'Division of Dental Hygiene, University of Minnesota School of Dentistry, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Kinney', 'Affiliation': 'Department of Periodontics and Oral Medicine, University of Michigan School of Dentistry, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Hom-Lay', 'Initials': 'HL', 'LastName': 'Wang', 'Affiliation': 'Department of Periodontics and Oral Medicine, University of Michigan School of Dentistry, Ann Arbor, Michigan, USA.'}]",Journal of periodontology,['10.1002/JPER.20-0040'] 1204,32757835,OPT-In For Life: A Mobile Technology-Based Intervention to Improve HIV Care Continuum for Young Adults Living With HIV.,"Young adults living with HIV (YALH) have lower rates of retention in care and HIV viral suppression. Multiple barriers exist to engage YALH in care. We developed and implemented a multifaceted, mobile application-based intervention, ""OPT-In for Life,"" by targeting YALH to encourage retention in care and eventually viral suppression. The app integrated multiple user-friendly features for YALH to manage their HIV care, including a two-way secure messaging function, HIV-related laboratory results, and appointment or medication reminders. We recruited 92 YALH who were 18 to 34 years old and were newly diagnosed with HIV, had a history of falling out of care, or had a detectable HIV viral load into this intervention. Study participants used the app to manage their HIV care and to communicate and interact with their HIV care team. During the intervention period, the retention rate among our study participants increased from 41.3% at baseline to 78.6% at 6-month follow-up, maintained at 12-month follow-up (79.8%), and slightly decreased to 73.4% at 18-month follow-up but it was still significantly higher than the baseline retention rate ( p < .0001). The viral suppression rate (HIV RNA <200 copies/ml) increased from 64.1% at baseline to about 85% at 6-month and at 12-month follow-up and reached 91.4% at 18-month ( p = .0002) among participants who were retained in care. Our study demonstrated using a HIPAA-compliant mobile application as an effective intervention to engage YALH in care. This mobile technology-based intervention can be incorporated into routine clinical practice to improve HIV care continuum.",2020,The viral suppression rate (HIV RNA <200 copies/ml) increased from 64.1% at baseline to about 85% at 6-month and at 12-month follow-up and reached 91.4% at 18-month ( p = .0002) among participants who were retained in care.,"['Young adults living with HIV (YALH', 'We recruited 92 YALH who were 18 to 34 years old and were newly diagnosed with HIV, had a history of falling out of care, or had a detectable HIV viral load into this intervention', 'Young Adults Living With HIV', 'Study participants used the app to manage their HIV care and to communicate and interact with their HIV care team']",['Mobile Technology-Based Intervention'],"['retention rate', 'viral suppression rate']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1561668', 'cui_str': 'History of fall'}, {'cui': 'C0439787', 'cui_str': 'Out'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",,0.0297418,The viral suppression rate (HIV RNA <200 copies/ml) increased from 64.1% at baseline to about 85% at 6-month and at 12-month follow-up and reached 91.4% at 18-month ( p = .0002) among participants who were retained in care.,"[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Zurlo', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Du', 'Affiliation': 'Pennsylvania State University, Hershey, PA, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Haynos', 'Affiliation': 'Pennsylvania State University, Hershey, PA, USA.'}, {'ForeName': 'Verbenia', 'Initials': 'V', 'LastName': 'Collins', 'Affiliation': 'Pennsylvania State University, Hershey, PA, USA.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Eshak', 'Affiliation': 'Pennsylvania State University, Hershey, PA, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Whitener', 'Affiliation': 'Pennsylvania State University, Hershey, PA, USA.'}]",Health promotion practice,['10.1177/1524839920936247'] 1205,32757870,Healing of erosions in rheumatoid arthritis remains elusive: results with 24 months of the anabolic agent teriparatide.,"Objective: Erosion healing in rheumatoid arthritis (RA) is difficult to demonstrate. This extension study aimed to determine whether 2 years of teriparatide (TPTD) produces erosion healing. Method: Subjects in a previous 12 month randomized controlled trial of TPTD in RA were invited to receive 12 additional months of open-label TPTD. Eleven of the 24 original subjects were enrolled in the extension study, six of whom received TPTD in the final 12 months only. Subjects receiving 24 months of TPTD were assessed for reduction in erosion volume from baseline using computed tomography. We also compared erosion volumes between 12 and 24 months of TPTD. Large erosions in subjects receiving TPTD for 24 months were examined for volume change. Results: In the six patients who received 24 months of TPTD, there was no significant change in erosion volume at the metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints compared with baseline. The six subjects who received 24 months of TPTD had similar changes in erosion volume to the five who received 12 months of TPTD, in MCP (p = 0.17) and PIP (p = 0.63) joints. Assessment of large erosions in those receiving TPTD for 24 months showed no evidence of erosion healing. Conclusion: While this extension study was too small to be conclusive, we observed no evidence of reduction in erosion volume with the addition of TPTD for 24 months in subjects with RA in whom disease activity was controlled on a tumour necrosis factor inhibitor. This is consistent with our negative findings at 12 months.",2021,"The six subjects who received 24 months of TPTD had similar changes in erosion volume to the five who received 12 months of TPTD, in MCP (p = 0.17) and PIP (p = 0.63) joints.","['Subjects in a previous 12\xa0month randomized controlled trial of TPTD in RA', 'rheumatoid arthritis (RA', 'Eleven of the 24 original subjects were enrolled in the extension study, six of whom received TPTD in the final 12\xa0months only']","['TPTD', 'open-label TPTD', 'teriparatide (TPTD', 'anabolic agent teriparatide']","['erosion volumes', 'Healing of erosions', 'erosion volume', 'erosion volume at the metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints', 'erosion healing', 'Large erosions']","[{'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}]","[{'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1258800', 'cui_str': 'Anabolic Agents'}]","[{'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0549177', 'cui_str': 'Large'}]",24.0,0.0279013,"The six subjects who received 24 months of TPTD had similar changes in erosion volume to the five who received 12 months of TPTD, in MCP (p = 0.17) and PIP (p = 0.63) joints.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Duryea', 'Affiliation': ""Department of Radiology, Brigham and Women's Hospital , Boston, MA, USA.""}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Gravallese', 'Affiliation': 'Division of Rheumatology, University of Massachusetts Medical School , Worcester, MA, USA.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Wortman', 'Affiliation': ""Department of Radiology, Brigham and Women's Hospital , Boston, MA, USA.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': ""Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital , Boston, MA, USA.""}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Lu', 'Affiliation': ""Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital , Boston, MA, USA.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kay', 'Affiliation': 'Division of Rheumatology, University of Massachusetts Medical School , Worcester, MA, USA.'}, {'ForeName': 'D H', 'Initials': 'DH', 'LastName': 'Solomon', 'Affiliation': ""Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital , Boston, MA, USA.""}]",Scandinavian journal of rheumatology,['10.1080/03009742.2020.1772362'] 1206,32759258,Safety and tolerability of nintedanib in patients with systemic sclerosis-associated interstitial lung disease: data from the SENSCIS trial.,"OBJECTIVES To characterise the safety and tolerability of nintedanib and the dose adjustments used to manage adverse events in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). METHODS In the SENSCIS trial, patients with SSc-ILD were randomised to receive nintedanib 150 mg two times per day or placebo. To manage adverse events, treatment could be interrupted or the dose reduced to 100 mg two times per day. We assessed adverse events and dose adjustments over 52 weeks. RESULTS A total of 576 patients received nintedanib (n=288) or placebo (n=288). The most common adverse event was diarrhoea, reported in 75.7% of patients in the nintedanib group and 31.6% in the placebo group; diarrhoea led to permanent treatment discontinuation in 6.9% and 0.3% of patients in the nintedanib and placebo groups, respectively. In the nintedanib and placebo groups, respectively, 48.3% and 12.2% of patients had ≥1 dose reduction and/or treatment interruption, and adverse events led to permanent discontinuation of the trial drug in 16.0% and 8.7% of patients. The adverse events associated with nintedanib were similar across subgroups defined by age, sex, race and weight. The rate of decline in forced vital capacity in patients treated with nintedanib was similar irrespective of dose adjustments. CONCLUSIONS The adverse event profile of nintedanib in patients with SSc-ILD is consistent with its established safety and tolerability profile in patients with idiopathic pulmonary fibrosis. Dose adjustment is important to minimise the impact of adverse events and help patients remain on therapy.",2020,"The most common adverse event was diarrhoea, reported in 75.7% of patients in the nintedanib group and 31.6% in the placebo group; diarrhoea led to permanent treatment discontinuation in 6.9% and 0.3% of patients in the nintedanib and placebo groups, respectively.","['576 patients received nintedanib (n=288) or', 'patients with systemic sclerosis-associated interstitial lung disease', 'patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD', 'patients with SSc-ILD', 'patients with idiopathic pulmonary fibrosis']","['nintedanib', 'nintedanib 150\u2009mg two times per day or placebo', 'placebo']","['Safety and tolerability', 'safety and tolerability', 'diarrhoea', 'diarrhoea led to permanent treatment discontinuation', 'rate of decline in forced vital capacity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2930789', 'cui_str': 'nintedanib'}, {'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0036429', 'cui_str': 'Sclerosis'}, {'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}]","[{'cui': 'C2930789', 'cui_str': 'nintedanib'}, {'cui': 'C3859348', 'cui_str': 'nintedanib 150 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}]",576.0,0.200888,"The most common adverse event was diarrhoea, reported in 75.7% of patients in the nintedanib group and 31.6% in the placebo group; diarrhoea led to permanent treatment discontinuation in 6.9% and 0.3% of patients in the nintedanib and placebo groups, respectively.","[{'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Seibold', 'Affiliation': 'Scleroderma Research Consultants, LLC, Aiken, South Carolina, USA jamesrseibold@gmail.com.'}, {'ForeName': 'Toby M', 'Initials': 'TM', 'LastName': 'Maher', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Kristin B', 'Initials': 'KB', 'LastName': 'Highland', 'Affiliation': 'Respiratory Institute, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Shervin', 'Initials': 'S', 'LastName': 'Assassi', 'Affiliation': 'University of Texas Houston Medical School, Houston, Texas, USA.'}, {'ForeName': 'Arata', 'Initials': 'A', 'LastName': 'Azuma', 'Affiliation': 'Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Laura Kathleen', 'Initials': 'LK', 'LastName': 'Hummers', 'Affiliation': 'Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Costabel', 'Affiliation': 'Interstitial and Rare Lung Disease Unit, Department of Pneumology, Ruhrlandklinik, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'von Wangenheim', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Kohlbrenner', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, Connecticut, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Gahlemann', 'Affiliation': 'Boehringer Ingelheim (Schweiz) GmbH, Basel, Switzerland.'}, {'ForeName': 'Margarida', 'Initials': 'M', 'LastName': 'Alves', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Distler', 'Affiliation': 'Department of Rheumatology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217331'] 1207,32765139,"Enhancing Slow Oscillations and Increasing N3 Sleep Proportion with Supervised, Non-Phase-Locked Pink Noise and Other Non-Standard Auditory Stimulation During NREM Sleep.","Purpose In non-rapid eye movement (NREM) stage 3 sleep (N3), phase-locked pink noise auditory stimulation can amplify slow oscillatory activity (0.5-1 Hz). Open-loop pink noise auditory stimulation can amplify slow oscillatory and delta frequency activity (0.5-4 Hz). We assessed the ability of pink noise and other sounds to elicit delta power, slow oscillatory power, and N3 sleep. Participants and Methods Participants ( n = 8) underwent four consecutive inpatient nights in a within-participants design, starting with a habituation night. A registered polysomnographic technologist live-scored sleep stage and administered stimuli on randomized counterbalanced Enhancing and Disruptive nights, with a preceding Habituation night (night 1) and an intervening Sham night (night 3). A variety of non-phase-locked pink noise stimuli were used on Enhancing night during NREM; on Disruptive night, environmental sounds were used throughout sleep to induce frequent auditory-evoked arousals. Results Total sleep time did not differ between conditions. Percentage of N3 was higher in the Enhancing condition, and lower in the Disruptive condition, versus Sham. Standard 0.8 Hz pink noise elicited low-frequency power more effectively than other pink noise, but was not the most effective stimulus. Both pink noise on the ""Enhancing"" night and sounds intended to Disrupt sleep administered on the ""Disruptive"" night increased momentary delta and slow-wave activity (ie, during stimulation versus the immediate pre-stimulation period). Disruptive auditory stimulation degraded sleep with frequent arousals and increased next-day vigilance lapses versus Sham despite preserved sleep duration and momentary increases in delta and slow-wave activity. Conclusion These findings emphasize sound features of interest in ecologically valid, translational auditory intervention to increase restorative sleep. Preserving sleep continuity should be a primary consideration if auditory stimulation is used to enhance slow-wave activity.",2020,"Disruptive auditory stimulation degraded sleep with frequent arousals and increased next-day vigilance lapses versus Sham despite preserved sleep duration and momentary increases in delta and slow-wave activity. ",[],"['Open-loop pink noise auditory stimulation', 'polysomnographic technologist live-scored sleep stage and administered stimuli on randomized counterbalanced Enhancing and Disruptive nights, with a preceding Habituation night (night 1) and an intervening Sham night (night 3']","['ability of pink noise and other sounds to elicit delta power, slow oscillatory power, and N3 sleep', 'sleep duration and momentary increases in delta and slow-wave activity', 'momentary delta and slow-wave activity', 'Total sleep time', 'restorative sleep']",[],"[{'cui': 'C0559530', 'cui_str': 'Open loop'}, {'cui': 'C0332585', 'cui_str': 'Pink color'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0001164', 'cui_str': 'Stimulation, Acoustic'}, {'cui': 'C0260280', 'cui_str': 'Technologist'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0037319', 'cui_str': 'Sleep Stages'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0013170', 'cui_str': 'Drug habituation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0332585', 'cui_str': 'Pink color'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0234451', 'cui_str': 'Non-rapid eye movement sleep'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0858603', 'cui_str': 'Wave slowing'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0240526,"Disruptive auditory stimulation degraded sleep with frequent arousals and increased next-day vigilance lapses versus Sham despite preserved sleep duration and momentary increases in delta and slow-wave activity. ","[{'ForeName': 'Margeaux M', 'Initials': 'MM', 'LastName': 'Schade', 'Affiliation': 'Biobehavioral Health, Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Gina Marie', 'Initials': 'GM', 'LastName': 'Mathew', 'Affiliation': 'Biobehavioral Health, Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Roberts', 'Affiliation': 'Proactive Life, Inc., New York, NY, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gartenberg', 'Affiliation': 'Proactive Life, Inc., New York, NY, USA.'}, {'ForeName': 'Orfeu M', 'Initials': 'OM', 'LastName': 'Buxton', 'Affiliation': 'Biobehavioral Health, Pennsylvania State University, University Park, PA, USA.'}]",Nature and science of sleep,['10.2147/NSS.S243204'] 1208,32769519,"A Randomized, Double-Blinded Study Evaluating the Safety and Efficacy of AbobotulinumtoxinA Injections for Oily Skin of the Forehead: A Dose-Response Analysis.","BACKGROUND AbobotulinumtoxinA has been investigated for applications beyond facial rhytides, including the treatment of oily skin. OBJECTIVE The authors sought to investigate the optimal number of units and the duration of abobotulinumtoxinA for the treatment of oily skin. MATERIALS AND METHODS This randomized, double-blinded, placebo-controlled study included 50 male and female subjects that got either 0, 15, 30, or 45 units of abobotulinumtoxinA injected into their forehead. For the 6 months after treatment, subjects were evaluated for the effectiveness of the treatment in decreasing the oiliness of their skin and the duration of this effect. RESULTS Subjects in the treatment groups that received either 30 or 45 units of neurotoxin experienced a significant reduction in oily skin. This effect was present for the 6-month duration of the study. No treatment-related adverse events were reported during this study, and both subjects and investigators reported a high level of satisfaction with the treatment. CONCLUSION Thirty or 45 units of abobotulinumtoxinA are safe and effective doses in treating oily skin for improved cosmetic appearance.",2021,"No treatment-related adverse events were reported during this study, and both subjects and investigators reported a high level of satisfaction with the treatment. ","['50 male and female subjects that got either 0, 15, 30, or 45 units of abobotulinumtoxinA injected into their forehead', 'Oily Skin of the Forehead']","['placebo', 'AbobotulinumtoxinA Injections', 'neurotoxin', 'abobotulinumtoxinA']","['oily skin', 'cosmetic appearance', 'adverse events', 'Safety and Efficacy']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C2719424', 'cui_str': 'AbobotulinumtoxinA'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0016540', 'cui_str': 'Forehead structure'}, {'cui': 'C0234925', 'cui_str': 'Greasy skin'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2719424', 'cui_str': 'AbobotulinumtoxinA'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0027934', 'cui_str': 'Neurotoxin'}]","[{'cui': 'C0234925', 'cui_str': 'Greasy skin'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",50.0,0.121903,"No treatment-related adverse events were reported during this study, and both subjects and investigators reported a high level of satisfaction with the treatment. ","[{'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Kesty', 'Affiliation': 'Skin Laser and Surgery Specialists of NY and NJ, Hackensack, NJ.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Goldberg', 'Affiliation': 'Skin Laser and Surgery Specialists of NY and NJ, Hackensack, NJ.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002494'] 1209,32770685,Ablative Fractional Carbon Dioxide Laser and Autologous Platelet-Rich Plasma in the Treatment of Atrophic Acne Scars: A Comparative Clinico-Immuno-Histopathological Study.,"BACKGROUND AND OBJECTIVES To compare the efficacy of autologous platelet-rich plasma (PRP), ablative fractional carbon dioxide (FCO 2 ) laser, and their combination in the treatment of atrophic acne scars, both clinically and immuno-histopathologically. STUDY DESIGN/MATERIALS AND METHODS Sixty patients were randomly divided into three equal groups. Group 1 received intradermal PRP injection sessions. Group 2 received FCO 2 laser sessions. Group 3 received FCO 2 laser followed by intradermal PRP injection sessions. Each group received three sessions at monthly intervals. The final assessment took place 3 months after the last session. Skin biopsies were obtained before and 1 month after treatment sessions with pathological evaluation. RESULTS Combined PRP and FCO 2 laser-treated patients had a better clinical response, fewer side effects, and shorter downtime than FCO 2 laser alone. PRP-treated patients had some improvement but significantly lower than the other two groups. CONCLUSION The current study concluded that a combination of PRP and FCO 2 laser is an effective and safe modality in the treatment of atrophic acne scars with better results than PRP or FCO 2 laser alone. Lasers Surg. Med. © 2020 Wiley Periodicals LLC.",2021,"RESULTS Combined PRP and FCO 2 laser-treated patients had a better clinical response, fewer side effects, and shorter downtime than FCO 2 laser alone.","['Atrophic Acne Scars', 'Sixty patients']","['Ablative Fractional Carbon Dioxide Laser and Autologous Platelet-Rich Plasma', 'PRP and FCO 2 laser', 'FCO 2 laser followed by intradermal PRP injection sessions', 'intradermal PRP injection sessions', 'autologous platelet-rich plasma (PRP), ablative fractional carbon dioxide (FCO 2 ) laser, and their combination', 'FCO 2 laser sessions']","['Skin biopsies', 'atrophic acne scars', 'side effects, and shorter downtime']","[{'cui': 'C1274728', 'cui_str': 'Atrophic acne scar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}]","[{'cui': 'C0150866', 'cui_str': 'Biopsy of skin'}, {'cui': 'C1274728', 'cui_str': 'Atrophic acne scar'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]",60.0,0.0115931,"RESULTS Combined PRP and FCO 2 laser-treated patients had a better clinical response, fewer side effects, and shorter downtime than FCO 2 laser alone.","[{'ForeName': 'Esraa E', 'Initials': 'EE', 'LastName': 'El-Hawary', 'Affiliation': 'Department of Dermatology, Venereology, and Andrology, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Samia', 'Initials': 'S', 'LastName': 'Nassar', 'Affiliation': 'Department of Dermatology, Venereology, and Andrology, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Abeer A', 'Initials': 'AA', 'LastName': 'Hodeib', 'Affiliation': 'Department of Dermatology, Venereology, and Andrology, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mohamed M', 'Initials': 'MM', 'LastName': 'Shareef', 'Affiliation': 'Department of Pathology, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mohamed M', 'Initials': 'MM', 'LastName': 'Fawzy', 'Affiliation': 'Department of Dermatology, Venereology, and Andrology, Faculty of Medicine, Tanta University, Tanta, Egypt.'}]",Lasers in surgery and medicine,['10.1002/lsm.23306'] 1210,32780258,"Effects of Probiotics Supplementation on Gastrointestinal Symptoms and SIBO after Roux-en-Y Gastric Bypass: a Prospective, Randomized, Double-Blind, Placebo-Controlled Trial.","Bariatric surgery may cause undesirable gastrointestinal symptoms due to anatomical, functional and intestinal microbiota changes. PURPOSE The aim of this study was to evaluate the effect of probiotic supplementation on gastrointestinal symptoms and small intestine bacterial overgrowth (SIBO) in patients after Roux-en-Y gastric bypass (RYGB). MATERIALS AND METHODS This is a prospective, randomized, double-blind, placebo-controlled trial. The patients were randomized into Control Group (CG) (n = 39) and Probiotic Group (PG) (n = 34). The PG received tablets containing Lactobacillus acidophilus and Bifidobaterium lactis (5 billion CFU/strain) for 90 days, and the CG received tablets with starch. Both the Gastric Symptom Rating Scale (GSRS) questionnaire and 3-day food record were answered before surgery (T0) and after 45 days (T1) and 90 days of surgery (T2). At T0 and T2, hydrogen breath test was used to verify the presence of SIBO. RESULTS The prevalence of SIBO was similar among times, and the mean score of GSRS responses did not differ between groups at any time. However, PG patients reported less bloating compared to CG, more abdominal pain at T1 (which reduced at T2), more episodes of soft stools and nausea and less hunger pain after surgery, with no reports of urgent episodes to evacuate, even though they consumed more fat than the CG. CONCLUSIONS The supplementation of L. acidophilus and B. lactis is effective in reducing bloating, but without influencing the development of SIBO in the early postoperative period.",2021,"The prevalence of SIBO was similar among times, and the mean score of GSRS responses did not differ between groups at any time.","['after Roux-en-Y Gastric Bypass', 'patients after Roux-en-Y gastric bypass (RYGB']","['Control Group (CG', 'Placebo', 'Probiotics Supplementation', 'probiotic supplementation', 'Probiotic Group (PG', 'placebo']","['mean score of GSRS responses', 'prevalence of SIBO', 'episodes of soft stools and nausea', 'gastrointestinal symptoms and small intestine bacterial overgrowth (SIBO', 'Gastric Symptom Rating Scale (GSRS) questionnaire and 3-day food record', 'bloating', 'Gastrointestinal Symptoms and SIBO', 'abdominal pain', 'hunger pain']","[{'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0429688', 'cui_str': 'Symptom ratings'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0151521', 'cui_str': 'Bacterial resistance'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0577115', 'cui_str': 'Soft stool'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0581870', 'cui_str': 'Hunger pain'}]",,0.302262,"The prevalence of SIBO was similar among times, and the mean score of GSRS responses did not differ between groups at any time.","[{'ForeName': 'Nathalia Ramori Farinha', 'Initials': 'NRF', 'LastName': 'Wagner', 'Affiliation': 'Nutrition Department (Nassif Clinic), Santa Casa de Misericórdia de Curitiba Hospital, Rua Bruno Filgueira, 485 - Batel, 80240-220,, Curitiba, Paraná, Brazil. nathalia_farinha@yahoo.con.br.'}, {'ForeName': 'Marilia Rizzon Zaparolli', 'Initials': 'MRZ', 'LastName': 'Ramos', 'Affiliation': 'Clinical Surgery Department, Federal University of Parana, Curitiba, Brazil.'}, {'ForeName': 'Ligia', 'Initials': 'L', 'LastName': 'de Oliveira Carlos', 'Affiliation': 'Clinical Surgery Department, Federal University of Parana, Curitiba, Brazil.'}, {'ForeName': 'Magda Rosa Ramos', 'Initials': 'MRR', 'LastName': 'da Cruz', 'Affiliation': 'Pontifical Catholic University of Paraná (PUCPR), Curitiba, Brazil.'}, {'ForeName': 'Cesar Augusto', 'Initials': 'CA', 'LastName': 'Taconeli', 'Affiliation': 'Department of Statistics, Federal University of Paraná, Curitiba, Brazil.'}, {'ForeName': 'Alcides José Branco', 'Initials': 'AJB', 'LastName': 'Filho', 'Affiliation': 'Santa Casa de Misericórdia de Curitiba Hospital, Curitiba, Brazil.'}, {'ForeName': 'Luis Sergio', 'Initials': 'LS', 'LastName': 'Nassif', 'Affiliation': 'Santa Casa de Misericórdia de Curitiba Hospital, Curitiba, Brazil.'}, {'ForeName': 'Maria Eliana Madalozzo', 'Initials': 'MEM', 'LastName': 'Schieferdecker', 'Affiliation': 'Nutrition Department, Federal University of Parana, Curitiba, Brazil.'}, {'ForeName': 'Antônio Carlos Ligocki', 'Initials': 'ACL', 'LastName': 'Campos', 'Affiliation': 'Clinical Surgery Department, Federal University of Parana, Curitiba, Brazil.'}]",Obesity surgery,['10.1007/s11695-020-04900-x'] 1211,32772684,Direct Transfer to Angio-Suite Versus Computed Tomography-Transit in Patients Receiving Mechanical Thrombectomy: A Randomized Trial.,"BACKGROUND AND PURPOSE To quantify workflow metrics in patients receiving stroke imaging (noncontrast-enhanced computed tomography [CT] and CT-angiography) in either a computed-tomography scanner suite (CT-Transit [CTT]) or an angio-suite (direct transfer to angio-suite-[DTAS]-using flat-panel CT) before undergoing mechanical thrombectomy. METHODS Prospective, single-center investigator initiated randomized controlled trial in a comprehensive stroke center focusing on time from imaging to groin puncture (primary end point) and time from hospital admission to final angiographic result (secondary end point) in patients receiving mechanical thrombectomy for anterior circulation large vessel occlusion after randomization to the CTT or DTAS pathway. RESULTS The trial was stopped early after the enrollment of n=60 patients (CTT: n=34/60 [56.7 %]; DTAS: n=26/60 [43.3%]) of n=110 planned patients because of a preplanned interim analysis. Time from imaging to groin puncture was shorter in DTAS-patients (in minutes, median [interquartile range]: CTT: 26 [23-32]; DTAS: 19 [15-23]; P value: 0.001). Time from hospital admission to stroke imaging was shorter in patients randomized to DTAS (CTT: 12 (7-18); DTAS: 21 (15-25), P value: 0.007). Time from hospital admission to final angiographic reperfusion was comparable between patient groups (CTT: 78 [58-92], DTAS: 80 [66-118]; P value: 0.067). CONCLUSIONS This trial showed a reduction in time from imaging to groin-puncture when patients are transferred directly to the angiosuite for advanced stroke-imaging compared with imaging in a CT scanner suite. This time saving was outweighed by a longer admission to imaging time and could not translate into a shorter time to final angiographic reperfusion in this trial.",2020,Time from hospital admission to stroke imaging was shorter in patients randomized to DTAS,"['n=60 patients (CTT: n=34/60 [56.7 %]; DTAS', 'Patients Receiving Mechanical Thrombectomy', 'patients receiving mechanical thrombectomy for anterior circulation large vessel occlusion after randomization to the CTT or DTAS pathway', 'patients receiving']","['angio-suite (direct transfer to angio-suite-[DTAS]-using flat-panel CT', 'Direct Transfer to Angio-Suite Versus Computed Tomography-Transit', 'stroke imaging (noncontrast-enhanced computed tomography [CT] and CT-angiography', 'DTAS', 'computed-tomography scanner suite (CT-Transit [CTT']","['Time from imaging to groin puncture', 'Time from hospital admission to final angiographic reperfusion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0225990', 'cui_str': 'Large blood vessel structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0018246', 'cui_str': 'Inguinal'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}]",,0.0900532,Time from hospital admission to stroke imaging was shorter in patients randomized to DTAS,"[{'ForeName': 'Johannes A R', 'Initials': 'JAR', 'LastName': 'Pfaff', 'Affiliation': 'Department of Neuroradiology (J.A.R.P., C.H., C.U., M.B., M.A.M.), Heidelberg University Hospital, Germany.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Schönenberger', 'Affiliation': 'Department of Neurology (S.S., S.N., P.A.R.), Heidelberg University Hospital, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Herweh', 'Affiliation': 'Department of Neuroradiology (J.A.R.P., C.H., C.U., M.B., M.A.M.), Heidelberg University Hospital, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ulfert', 'Affiliation': 'Department of Neuroradiology (J.A.R.P., C.H., C.U., M.B., M.A.M.), Heidelberg University Hospital, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Nagel', 'Affiliation': 'Department of Neurology (S.S., S.N., P.A.R.), Heidelberg University Hospital, Germany.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Ringleb', 'Affiliation': 'Department of Neurology (S.S., S.N., P.A.R.), Heidelberg University Hospital, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bendszus', 'Affiliation': 'Department of Neuroradiology (J.A.R.P., C.H., C.U., M.B., M.A.M.), Heidelberg University Hospital, Germany.'}, {'ForeName': 'Markus A', 'Initials': 'MA', 'LastName': 'Möhlenbruch', 'Affiliation': 'Department of Neuroradiology (J.A.R.P., C.H., C.U., M.B., M.A.M.), Heidelberg University Hospital, Germany.'}]",Stroke,['10.1161/STROKEAHA.120.029905'] 1212,32804188,Effect of Sustained-Release Morphine for Refractory Breathlessness in Chronic Obstructive Pulmonary Disease on Health Status: A Randomized Clinical Trial.,"Importance Morphine is used as palliative treatment of chronic breathlessness in patients with advanced chronic obstructive pulmonary disease (COPD). Evidence on respiratory adverse effects and health status is scarce and conflicting. Objective To assess the effects of regular, low-dose, oral sustained-release morphine on disease-specific health status (COPD Assessment Test; CAT), respiratory outcomes, and breathlessness in patients with COPD. Interventions Participants were randomly assigned to 10 mg of regular, oral sustained-release morphine or placebo twice daily for 4 weeks, with the possibility to increase to 3 times daily after 1 or 2 weeks. Design, Setting, and Participants The Morphine for Treatment of Dyspnea in Patients With COPD (MORDYC) study was a randomized, double-blind, and placebo-controlled study of a 4-week intervention. Patients were enrolled between November 1, 2016, and January 24, 2019. Participants were recruited in a pulmonary rehabilitation center and 2 general hospitals after completion of a pulmonary rehabilitation program. Outpatients with COPD and moderate to very severe chronic breathlessness (modified Medical Research Council [mMRC] breathlessness grades 2-4) despite optimal pharmacological and nonpharmacological treatment were included. A total of 1380 patients were screened, 916 were ineligible, and 340 declined to participate. Main Outcomes and Measures Primary outcomes were CAT score (higher scores represent worse health status) and arterial partial pressure of carbon dioxide (Paco2). Secondary outcome was breathlessness in the previous 24 hours (numeric rating scale). Data were analyzed by intention to treat. Subgroup analyses in participants with mMRC grades 3 to 4 were performed. Results A total of 111 of 124 included participants were analyzed (mean [SD] age, 65.4 [8.0] years; 60 men [54%]). Difference in CAT score was 2.18 points lower in the morphine group (95% CI, -4.14 to -0.22 points; P = .03). Difference in Paco2 was 1.19 mm Hg higher in the morphine group (95% CI, -2.70 to 5.07 mm Hg; P = .55). Breathlessness remained unchanged. Worst breathlessness improved in participants with mMRC grades 3 to 4 (1.33 points lower in the morphine group; 95% CI, -2.50 to -0.16 points; P = .03). Five participants of 54 in the morphine group (9%) and 1 participant of 57 in the placebo group (2%) withdrew because of adverse effects. No morphine-related hospital admissions or deaths occurred. Conclusions and Relevance In this randomized clinical trial, regular, low-dose, oral sustained-release morphine for 4 weeks improved disease-specific health status in patients with COPD without affecting Paco2 or causing serious adverse effects. The worst breathlessness improved in participants with mMRC grades 3 to 4. A larger randomized clinical trial with longer follow-up in patients with mMRC grades 3 to 4 is warranted. Trial Registration ClinicalTrials.gov Identifier: NCT02429050.",2020,"Worst breathlessness improved in participants with mMRC grades 3 to 4 (1.33 points lower in the morphine group; 95% CI, -2.50 to -0.16 points; P = .03).","['Patients With COPD (MORDYC', 'A total of 111 of 124 included participants were analyzed (mean [SD] age, 65.4 [8.0] years; 60 men [54', 'patients with COPD without affecting Paco2 or causing serious adverse effects', 'Patients were enrolled between November 1, 2016, and January 24, 2019', 'participants with mMRC grades 3 to 4 were performed', 'Outpatients with COPD and moderate to very severe chronic breathlessness (modified Medical Research Council [mMRC] breathlessness grades 2-4', 'patients with COPD', 'A total of 1380 patients were screened, 916 were ineligible, and 340 declined to participate', 'patients with advanced chronic obstructive pulmonary disease (COPD', 'Chronic Obstructive Pulmonary Disease on Health Status', 'patients with mMRC grades 3 to 4 is warranted', 'Participants were recruited in a pulmonary rehabilitation center and 2 general hospitals after completion of a pulmonary rehabilitation program']","['regular, oral sustained-release morphine or placebo', 'morphine', 'oral sustained-release morphine', 'regular, low-dose, oral sustained-release morphine', 'Morphine', 'Sustained-Release Morphine', 'placebo']","['Worst breathlessness', 'adverse effects', 'CAT score', 'Breathlessness', 'Difference in Paco2', 'CAT score (higher scores represent worse health status) and arterial partial pressure of carbon dioxide (Paco2', 'worst breathlessness', 'hospital admissions or deaths occurred', 'disease-specific health status (COPD Assessment Test; CAT), respiratory outcomes, and breathlessness', 'disease-specific health status', 'breathlessness in the previous 24 hours (numeric rating scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C1136454', 'cui_str': 'Refusal to Participate'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}]","[{'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0428190', 'cui_str': 'Measurement of arterial partial pressure of carbon dioxide'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",1380.0,0.443493,"Worst breathlessness improved in participants with mMRC grades 3 to 4 (1.33 points lower in the morphine group; 95% CI, -2.50 to -0.16 points; P = .03).","[{'ForeName': 'Cornelia A', 'Initials': 'CA', 'LastName': 'Verberkt', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Marieke H J', 'Initials': 'MHJ', 'LastName': 'van den Beuken-van Everdingen', 'Affiliation': 'Centre of Expertise for Palliative Care, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Jos M G A', 'Initials': 'JMGA', 'LastName': 'Schols', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Hameleers', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Emiel F M', 'Initials': 'EFM', 'LastName': 'Wouters', 'Affiliation': 'Department of Research & Development, CIRO, Horn, the Netherlands.'}, {'ForeName': 'Daisy J A', 'Initials': 'DJA', 'LastName': 'Janssen', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.3134'] 1213,32799967,"Validation and calibration of the Eating Assessment in Toddlers FFQ (EAT FFQ) for children, used in the Growing Up Milk - Lite (GUMLi) randomised controlled trial.","The Eating Assessment in Toddlers FFQ (EAT FFQ) has been shown to have good reliability and comparative validity for ranking nutrient intakes in young children. With the addition of food items (n 4), we aimed to re-assess the validity of the EAT FFQ and estimate calibration factors in a sub-sample of children (n 97) participating in the Growing Up Milk - Lite (GUMLi) randomised control trial (2015-2017). Participants completed the ninety-nine-item GUMLi EAT FFQ and record-assisted 24-h recalls (24HR) on two occasions. Energy and nutrient intakes were assessed at months 9 and 12 post-randomisation and calibration factors calculated to determine predicted estimates from the GUMLi EAT FFQ. Validity was assessed using Pearson correlation coefficients, weighted kappa (κ) and exact quartile categorisation. Calibration was calculated using linear regression models on 24HR, adjusted for sex and treatment group. Nutrient intakes were significantly correlated between the GUMLi EAT FFQ and 24HR at both time points. Energy-adjusted, de-attenuated Pearson correlations ranged from 0·3 (fibre) to 0·8 (Fe) at 9 months and from 0·3 (Ca) to 0·7 (Fe) at 12 months. Weighted κ for the quartiles ranged from 0·2 (Zn) to 0·6 (Fe) at 9 months and from 0·1 (total fat) to 0·5 (Fe) at 12 months. Exact agreement ranged from 30 to 74 %. Calibration factors predicted up to 56 % of the variation in the 24HR at 9 months and 44 % at 12 months. The GUMLi EAT FFQ remained a useful tool for ranking nutrient intakes with similar estimated validity compared with other FFQ used in children under 2 years.",2021,The GUMLi EAT FFQ remained a useful tool for ranking nutrient intakes with similar estimated validity compared with other FFQ used in children under 2 years.,"['Toddlers FFQ (EAT FFQ) for children', 'young children', 'sub-sample of children (n 97) participating in the Growing Up Milk - Lite (GUMLi) randomised control trial (2015-2017', 'Toddlers FFQ (EAT FFQ']",[],"['Energy and nutrient intakes', 'Nutrient intakes']","[{'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0006777', 'cui_str': 'Energy intake'}]",,0.0654151,The GUMLi EAT FFQ remained a useful tool for ranking nutrient intakes with similar estimated validity compared with other FFQ used in children under 2 years.,"[{'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Lovell', 'Affiliation': 'Discipline of Nutrition and Dietetics, Faculty of Medical and Health Sciences, University of Auckland, Auckland, 1023, New Zealand.'}, {'ForeName': 'Peter S W', 'Initials': 'PSW', 'LastName': 'Davies', 'Affiliation': ""Children's Nutrition Research Centre, UQ Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, 4101, Australia.""}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Hill', 'Affiliation': ""Children's Nutrition Research Centre, UQ Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, 4101, Australia.""}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Milne', 'Affiliation': 'Discipline of Nutrition and Dietetics, Faculty of Medical and Health Sciences, University of Auckland, Auckland, 1023, New Zealand.'}, {'ForeName': 'Misa', 'Initials': 'M', 'LastName': 'Matsuyama', 'Affiliation': ""Children's Nutrition Research Centre, UQ Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, 4101, Australia.""}, {'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Statistics, Faculty of Science, University of Auckland, Auckland, 1010, New Zealand.'}, {'ForeName': 'Rachel X', 'Initials': 'RX', 'LastName': 'Chen', 'Affiliation': 'Department of Statistics, Faculty of Science, University of Auckland, Auckland, 1010, New Zealand.'}, {'ForeName': 'Anne-Louise M', 'Initials': 'AM', 'LastName': 'Heath', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, 9016, New Zealand.'}, {'ForeName': 'Cameron C', 'Initials': 'CC', 'LastName': 'Grant', 'Affiliation': 'Department of Paediatrics: Child and Youth Health, University of Auckland, Auckland, 1023, New Zealand.'}, {'ForeName': 'Clare R', 'Initials': 'CR', 'LastName': 'Wall', 'Affiliation': 'Discipline of Nutrition and Dietetics, Faculty of Medical and Health Sciences, University of Auckland, Auckland, 1023, New Zealand.'}]",The British journal of nutrition,['10.1017/S0007114520002664'] 1214,32802319,Effects of rehabilitation training on an elderly population with mild to moderate hearing loss: study protocol for a randomised clinical trial.,"Background: Age-related hearing loss (presbycusis) is a form of hearing loss in over 60-years-olds and has a negative impact on quality of life. Presbycusis is multifactorial and is predominately characterised with a loss of speech perception in noise. In the cochlea, auditory filters decompose broadband sound into a series of narrowband output signals, which contains two kinds of temporal information: slow changes in overall amplitude envelope (ENV) and faster variations in temporal fine structure (TFS). TFS is important for recognition of target speech in noise. The main aim of the study is to evaluate the effect of TFS rehabilitation training in participants over the age of 60 years with mild to moderate hearing loss. Methods: A randomised clinical trial  conducted on 30 participants with mild (loss of 20-39dB HL) to moderate (40-69dB HL) hearing loss, aged between 60 and 75 years old. Participants with conductive hearing loss, abnormal middle ear pathology and central nervous system disease were excluded. Participants were selected randomly  to an intervention and control group with a 1:1 ratio. Rehabilitation for the intervention Group are 30-minute sessions three times a week for a total five weeks of vowel consonant vowel words that are used to eliminate ENV and keep only TFS. Word in noise test, binaural TFS test, and Speech, Spatial and Qualities of Hearing Scale scores are performed at the beginning and end of study to evaluate the effect of rehabilitation training. Conclusion:  Life expectancy in the elderly has improved, leading to an increased prevalence of age-related diseases including presbycusis. A literature review highlighted that TFS damage is permanent; however, in this study we will attempt to prove that TFS training may lead to speech in noise perception improvement. Trial registration: Registry of Clinical Trials, IRCT2019625044006N1 (7 th August 2019).",2020,"Life expectancy in the elderly has improved, leading to an increased prevalence of age-related diseases including presbycusis.","['participants over the age of 60 years with mild to moderate hearing loss', '30 participants with mild (loss of 20-39dB) to moderate (40-69dB) hearing loss, aged between 60 and 75 years old', 'elderly population with mild to moderate hearing loss', 'Participants with conductive hearing loss, abnormal middle ear pathology and central nerve system disease']","['rehabilitation training', 'TFS training', 'TFS rehabilitation training', 'TFS']","['Word in noise test, binaural TFS test, and Speech, Spatial and Qualities of Hearing Scale scores', 'Life expectancy']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1852284', 'cui_str': 'Mild to moderate hearing loss'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0018777', 'cui_str': 'Conductive hearing loss'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0013455', 'cui_str': 'Middle ear structure'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}]",30.0,0.067655,"Life expectancy in the elderly has improved, leading to an increased prevalence of age-related diseases including presbycusis.","[{'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Rasouli Fard', 'Affiliation': 'Department of Audiology, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, 15459-13487, Iran.'}, {'ForeName': 'Farnoush', 'Initials': 'F', 'LastName': 'Jarollahi', 'Affiliation': 'Department of Audiology, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, 15459-13487, Iran.'}, {'ForeName': 'Seyyed Jalal', 'Initials': 'SJ', 'LastName': 'Sameni', 'Affiliation': 'Department of Audiology, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, 15459-13487, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Kamali', 'Affiliation': 'Department of Audiology, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, 15459-13487, Iran.'}]",F1000Research,['10.12688/f1000research.23332.3'] 1215,32761890,Two-year outcomes after percutaneous coronary intervention with drug-eluting stents or bare-metal stents in elderly patients with coronary artery disease.,"OBJECTIVES Report the results at 2 years of the patients included in the SENIOR trial. BACKGROUND Patients above 75 years of age represent a fast-growing population in the cathlab. In the SENIOR trial, patients treated by percutaneous coronary intervention (PCI) with drug eluting stent (DES) and a short duration of P2Y12 inhibitor (1 and 6 months for stable and unstable coronary syndromes, respectively) compared with bare metal stents (BMS) was associated with a 29% reduction in the rate of all-cause mortality, myocardial infarction (MI), stroke, and ischaemia-driven target lesion revascularization (ID-TLR) at 1 year. The results at 2 years are reported here. METHODS AND RESULTS We randomly assigned 1,200 patients (596[50%] to the DES group and 604[50%] to the BMS group). At 2 years, the composite endpoint of all-cause mortality, MI, stroke and ID-TLR had occurred in 116 (20%) patients in the DES group and 131 (22%) patients in the BMS group (RR 0.90 [95%CI 0.72-1.13], p = .37). IDTLR occurred in 14 (2%) patients in the DES group and 41 (7%) patients in the BMS group (RR 0.35 [95%CI 0.16-0.60], p = .0002). Major bleedings (BARC 3-5) occurred in 27(5%) patients in both groups (RR 1.00, [95%CI 0.58-1.75], p = .99). Stent thrombosis rates were low and similar between DES and BMS (0.8 vs 1.3%, (RR 0.52 [95%CI 0.01-1.95], p = .27). CONCLUSION Among elderly PCI patients, a strategy combining a DES together with a short duration of DAPT is associated with a reduction in revascularization up to 2 years compared with BMS with very few late events and without any increased in bleeding complications or stent thrombosis.",2021,"Stent thrombosis rates were low and similar between DES and BMS (0.8 vs 1.3%, (RR 0.52","['2 years of the patients included in the SENIOR trial', 'elderly PCI patients', 'Patients above 75\u2009years of age represent a fast-growing population in the cathlab', 'elderly patients with coronary artery disease']","['DES', 'percutaneous coronary intervention with drug-eluting stents or bare-metal stents', 'bare metal stents (BMS', 'percutaneous coronary intervention (PCI) with drug eluting stent (DES']","['Stent thrombosis rates', 'bleeding complications or stent thrombosis', 'Major bleedings', 'TLR', 'rate of all-cause mortality, myocardial infarction (MI), stroke, and ischaemia-driven target lesion revascularization (ID-TLR', 'composite endpoint of all-cause mortality, MI, stroke and ID', 'IDTLR', 'DES and BMS']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C2825200', 'cui_str': 'Bare metal stent'}]","[{'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C2825200', 'cui_str': 'Bare metal stent'}]",1200.0,0.0960011,"Stent thrombosis rates were low and similar between DES and BMS (0.8 vs 1.3%, (RR 0.52","[{'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Lafont', 'Affiliation': 'Cardiology Department Hôpital Cochin, Assistance Publique-Hôpitaux de Paris and, Université de Paris, Paris, France.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Sinnaeve', 'Affiliation': 'Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Cuisset', 'Affiliation': 'Cardiology Department, Centre Hospitalier Universitaire Timone, Marseille, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Cook', 'Affiliation': 'Cardiology Department, University and Hospital Fribourg, Fribourg, Switzerland.'}, {'ForeName': 'Giorgios', 'Initials': 'G', 'LastName': 'Sideris', 'Affiliation': 'Cardiology Department Service de Cardiologie-Institut national de la santé et de la recherche médicale U942, Hôpital Lariboisiere, Assistance Publique-Hôpitaux de Paris, Université Paris Diderot, Paris, France.'}, {'ForeName': 'Sasko', 'Initials': 'S', 'LastName': 'Kedev', 'Affiliation': 'Cardiology Department, University St Cyril and Methodius, Skopje, Macedonia.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Carrie', 'Affiliation': 'Service de Cardiologie, Centre hospitalier universitaire Toulouse Rangueil, Université Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hovasse', 'Affiliation': 'Institut Cardiovasculaire Paris-Sud, Ramsay Générale de Santé, Massy, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Garot', 'Affiliation': 'Institut Cardiovasculaire Paris-Sud, Ramsay Générale de Santé, Massy, France.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'El Mahmoud', 'Affiliation': 'Hôpital Ambroise Paré Assistance Publique-Hôpitaux de Paris, Université Versailles-Saint Quentin en Yvelines, Versailles, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Spaulding', 'Affiliation': 'Service de Cardiologie, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université de Paris and Sudden Death Expert Center, Institut national de la santé et de la recherche médicale U990, Paris, France.'}, {'ForeName': 'Gérard', 'Initials': 'G', 'LastName': 'Helft', 'Affiliation': 'Institut de Cardiologie, Hôpital Pitié-Salpétrière, Assistance Publique-Hôpitaux de Paris, Université Pierre et Marie Curie et Institut hospitalo-universitaire, Institute of Cardiometabolism and Nutrition, Hôpital Pitié-Salpétrière, Paris, France.'}, {'ForeName': 'José F', 'Initials': 'JF', 'LastName': 'Diaz Fernandez', 'Affiliation': 'Cardiology department, Juan Ramón Jiménez University Hospital, Huelva, Spain.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Brugaletta', 'Affiliation': ""Cardiovascular Institute, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.""}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Pinar-Bermudez', 'Affiliation': 'Cardiology department, Hospital Universitario Virgen de la Arrixaca, Murcia, Spain.'}, {'ForeName': 'Josepa Mauri', 'Initials': 'JM', 'LastName': 'Ferre', 'Affiliation': 'Cardiology department, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Commeau', 'Affiliation': 'Département de Cardiologie Interventionnelle, Polyclinique Les Fleurs, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Teiger', 'Affiliation': 'Service de Cardiologie, Hôpital Henri Mondor Assistance Publique-Hôpitaux de Paris, Université Paris Est Créteil, Créteil, France.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Bogaerts', 'Affiliation': 'Interuniversity Institute for Biostatistics and Statistical Bioinformatics (I-BioStat), Department of Public Health and Primary Care, Katholieke Universiteit Leuven, Leuven, Belgium, and Interuniversity Institute for Biostatistics and Statistical Bioinformatics (I-BioStat), University Hasselt, Hasselt, Belgium.'}, {'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Sabate', 'Affiliation': ""Interventional Cardiology Unit, Cardiovascular Institute, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.""}, {'ForeName': 'Marie Claude', 'Initials': 'MC', 'LastName': 'Morice', 'Affiliation': 'CERC (Cardiovascular European Research Center), Massy, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Varenne', 'Affiliation': 'Cardiology Department Hôpital Cochin, Assistance Publique-Hôpitaux de Paris and, Université de Paris, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.29159'] 1216,32761909,Topical phenytoin effects on palatal wound healing.,"BACKGROUND The clinical benefits of autogenous soft tissue grafts are countered by donor site morbidity. The aim of this prospective split-mouth clinical trial is to assess clinical, histological and patient outcomes following topical phenytoin (PHT) treatment of experimental palatal wounds. METHODS Systemically healthy adults were recruited. One 6 mm diameter wound (posterior) and one 4 mm diameter wound (anterior), each 1-1.5 mm deep, were created on both sides of the palate. Wounds on one randomly chosen side received 10% phenytoin USP and contralateral wounds received carrier alone. Biopsies were harvested from anterior wounds (Day 1 or Day 5) and were routinely processed for histology. Posterior wounds were left undisturbed to clinically evaluate healing (using photographs and Healing Score Index) on Days 1, 5, 14, and 21. Questionnaires were used to assess patient-centered outcomes. Data analysis was performed using generalized logistic and generalized linear mixed models. RESULTS Twenty participants completed all visits. 30% of participants reported more pain on control side than the PHT side at Day 1 (P = 0.014). PHT treated sites were more likely to not exhibit swelling (OR = 9.35; P = 0.009) and to not experience pain on palpation (OR = 6.278; P = 0.007). PHT significantly and time-dependently affected granulation tissue appearance (P = 0.004). Histologically, there were no significant differences between control and PHT, at any time point (P ≥ 0.853). CONCLUSIONS The results of the present study, the first one to report on topical PHT as palatal wound treatment, suggest that PHT application on palatal wounds could result in improved healing outcomes.",2021,PHT treated sites were more likely to not exhibit swelling (OR = 9.35; p = 0.009) and to not experience pain on palpation (OR = 6.278; p = 0.007).,"['experimental palatal wounds', '20 participants completed all visits', 'Systemically healthy adults were recruited']","['topical phenytoin (PHT', 'phenytoin USP and contralateral wounds received carrier alone', 'Topical phenytoin']","['pain on control side', 'healing outcomes', 'granulation tissue appearance', 'palatal wound healing']","[{'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0031507', 'cui_str': 'Phenytoin'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018180', 'cui_str': 'Granulation tissue'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}]",1.0,0.0375099,PHT treated sites were more likely to not exhibit swelling (OR = 9.35; p = 0.009) and to not experience pain on palpation (OR = 6.278; p = 0.007).,"[{'ForeName': 'Anuja', 'Initials': 'A', 'LastName': 'Doshi', 'Affiliation': 'Division of Periodontology, College of Dentistry, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'McAuley', 'Affiliation': 'College of Pharmacy, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Dimitris N', 'Initials': 'DN', 'LastName': 'Tatakis', 'Affiliation': 'Division of Periodontology, College of Dentistry, The Ohio State University, Columbus, Ohio, USA.'}]",Journal of periodontology,['10.1002/JPER.20-0340'] 1217,32772319,Does cognitive behavioral education reduce pain and improve joint function in patients after total knee arthroplasty? A randomized controlled trial.,"INTRODUCTION Cognitive behavioral therapy (CBT) is an effective treatment for reducing the pain of knee osteoarthritis (OA) and improving joint function. However, there are few studies on the effect of CBT on the pain severity after total knee arthroplasty (TKA). This study investigates the effectiveness of a CBT program on pain, knee function, quality of life, and pain catastrophizing in patients after TKA. METHODS This was a randomized, parallel-group, controlled trial in which 100 patients with knee osteoarthritis (OA) prepared for TKA were randomly assigned to participate in CBT or usual care group. Evaluation outcomes include Visual Analogue Scale (VAS), Pain Catastrophizing Scale (PCS), Oxford Knee Score (OKS), Knee Range of Motion (ROM), EuroQol Five-Dimensional (EQ-5D), and Hospital for Special Surgery (HSS) Knee Rating Scale before and after surgery. RESULTS We found that patients in the CBT group had a lower pain during activity from the fifth day (p = 0.003) to the third month (p = 0.019) after TKA. At the 12th month, the mean VAS score during activity in the CBT and usual care groups decreased from 4.5 to 0.8 and from 4.6 to 0.9, respectively, and there is no significant difference between the two groups. The PCS scores of patients in the CBT group were lower than those in the usual care group at 1st (p = 0.014) and 3rd months (p = 0.027) after surgery. No statistically significantly differences between the two groups in pain during rest, knee ROM, EQ-5D, OKS, and HSS. CONCLUSIONS The CBT program was superior to usual care in reducing post-operative pain during activity from the fifth day to the third month and pain catastrophing in the first three months after TKA but has no statistically significantly differences in pain during rest, knee ROM, EQ-5D, OKS, and HSS. TRIAL REGISTRATION Current Controlled Trials ChiCTR2000032857, date of registration: May, 14, 2020, retrospectively registered.",2020,"No statistically significantly differences between the two groups in pain during rest, knee ROM, EQ-5D, OKS, and HSS. ","['patients after TKA', '100 patients with knee osteoarthritis (OA) prepared for TKA', 'patients after total knee arthroplasty']","['CBT or usual care group', 'Cognitive behavioral therapy (CBT', 'CBT program', 'CBT']","['PCS scores', 'pain, knee function, quality of life, and pain catastrophizing', 'lower pain during activity', 'pain during rest, knee ROM, EQ-5D, OKS, and HSS', 'Visual Analogue Scale (VAS), Pain Catastrophizing Scale (PCS), Oxford Knee Score (OKS), Knee Range of Motion (ROM), EuroQol Five-Dimensional (EQ-5D), and Hospital for Special Surgery (HSS) Knee Rating Scale', 'joint function', 'pain severity', 'mean VAS score during activity', 'pain of knee osteoarthritis (OA) and improving joint function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0576094', 'cui_str': 'Knee joint - range of movement'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0542330', 'cui_str': 'Joint mobilization'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",100.0,0.0581903,"No statistically significantly differences between the two groups in pain during rest, knee ROM, EQ-5D, OKS, and HSS. ","[{'ForeName': 'Jian-Ning', 'Initials': 'JN', 'LastName': 'Sun', 'Affiliation': ""Department of Orthopaedic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huaihai Road, Xuzhou, 221002, Jiangsu, People's Republic of China.""}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ""Department of Orthopaedic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huaihai Road, Xuzhou, 221002, Jiangsu, People's Republic of China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopaedic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huaihai Road, Xuzhou, 221002, Jiangsu, People's Republic of China.""}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopaedic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huaihai Road, Xuzhou, 221002, Jiangsu, People's Republic of China.""}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': ""Department of Orthopaedic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huaihai Road, Xuzhou, 221002, Jiangsu, People's Republic of China. xzfs0561@163.com.""}, {'ForeName': 'Xiang-Yang', 'Initials': 'XY', 'LastName': 'Chen', 'Affiliation': ""Department of Orthopaedic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huaihai Road, Xuzhou, 221002, Jiangsu, People's Republic of China. 781733181@qq.com.""}]",International orthopaedics,['10.1007/s00264-020-04767-8'] 1218,32779573,Evaluation of a Stepped-Care eHealth HIV Prevention Program for Diverse Adolescent Men Who Have Sex With Men: Protocol for a Hybrid Type 1 Effectiveness Implementation Trial of SMART.,"BACKGROUND Adolescent men who have sex with men (AMSM), aged 13 to 18 years, account for more than 80% of teen HIV occurrences. Despite this disproportionate burden, there is a conspicuous lack of evidence-based HIV prevention programs. Implementation issues are critical as traditional HIV prevention delivery channels (eg, community-based organizations, schools) have significant access limitations for AMSM. As such, eHealth interventions, such as our proposed SMART program, represent an excellent modality for delivering AMSM-specific intervention material where youth are. OBJECTIVE This randomized trial aimed to test the effectiveness of the SMART program in reducing condom-less anal sex and increasing condom self-efficacy, condom use intentions, and HIV testing for AMSM. We also plan to test whether SMART has differential effectiveness across important subgroups of AMSM based on race and ethnicity, urban versus rural residence, age, socioeconomic status, and participation in an English versus a Spanish version of SMART. METHODS Using a sequential multiple assignment randomized trial design, we will evaluate the impact of a stepped-care package of increasingly intensive eHealth interventions (ie, the universal, information-based SMART Sex Ed; the more intensive, selective SMART Squad; and a higher cost, indicated SMART Sessions). All intervention content is available in English and Spanish. Participants are recruited primarily from social media sources using paid and unpaid advertisements. RESULTS The trial has enrolled 1285 AMSM aged 13 to 18 years, with a target enrollment of 1878. Recruitment concluded in June 2020. Participants were recruited from 49 US states as well as Puerto Rico and the District of Columbia. Assessments of intervention outcomes at 3, 6, 9, and 12 months are ongoing. CONCLUSIONS SMART is the first web-based program for AMSM to take a stepped-care approach to sexual education and HIV prevention. This design indicates that SMART delivers resources to all adolescents, but more costly treatments (eg, video chat counseling in SMART Sessions) are conserved for individuals who need them the most. SMART has the potential to reach AMSM to provide them with a sex-positive curriculum that empowers them with the information, motivation, and skills to make better health choices. TRIAL REGISTRATION ClinicalTrials.gov Identifier NCT03511131; https://clinicaltrials.gov/ct2/show/NCT03511131. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/19701.",2020,"CONCLUSIONS SMART is the first web-based program for AMSM to take a stepped-care approach to sexual education and HIV prevention.","['Diverse Adolescent Men', 'Participants are recruited primarily from social media sources using paid and unpaid advertisements', 'Adolescent men who have sex with men (AMSM), aged 13 to 18 years, account for more than 80% of teen HIV occurrences', 'Participants were recruited from 49 US states as well as Puerto Rico and the District of Columbia', 'enrolled 1285 AMSM aged 13 to 18 years, with a target enrollment of 1878', 'With Men']","['SMART program', 'Stepped-Care eHealth HIV Prevention Program', 'SMART']",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0012764', 'cui_str': 'District of Columbia'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}]","[{'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]",[],1285.0,0.0576676,"CONCLUSIONS SMART is the first web-based program for AMSM to take a stepped-care approach to sexual education and HIV prevention.","[{'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Mustanski', 'Affiliation': 'Institute for Sexual and Gender Minority Health and Wellbeing, Northwestern University, Chicago, IL, United States.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Moskowitz', 'Affiliation': 'Institute for Sexual and Gender Minority Health and Wellbeing, Northwestern University, Chicago, IL, United States.'}, {'ForeName': 'Kevin O', 'Initials': 'KO', 'LastName': 'Moran', 'Affiliation': 'Institute for Sexual and Gender Minority Health and Wellbeing, Northwestern University, Chicago, IL, United States.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Newcomb', 'Affiliation': 'Institute for Sexual and Gender Minority Health and Wellbeing, Northwestern University, Chicago, IL, United States.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Macapagal', 'Affiliation': 'Institute for Sexual and Gender Minority Health and Wellbeing, Northwestern University, Chicago, IL, United States.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Rodriguez-Díaz', 'Affiliation': 'Department of Prevention and Community Health, Milken Institute School of Public Health, George Washington University, Washington, DC, United States.'}, {'ForeName': 'H Jonathon', 'Initials': 'HJ', 'LastName': 'Rendina', 'Affiliation': 'Department of Psychology, Hunter College of the City University of New York (CUNY), New York, NY, United States.'}, {'ForeName': 'Eric B', 'Initials': 'EB', 'LastName': 'Laber', 'Affiliation': 'Department of Statistics, North Carolina State University, Raleigh, NC, United States.'}, {'ForeName': 'Dennis H', 'Initials': 'DH', 'LastName': 'Li', 'Affiliation': 'Institute for Sexual and Gender Minority Health and Wellbeing, Northwestern University, Chicago, IL, United States.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Matson', 'Affiliation': 'Institute for Sexual and Gender Minority Health and Wellbeing, Northwestern University, Chicago, IL, United States.'}, {'ForeName': 'Ali J', 'Initials': 'AJ', 'LastName': 'Talan', 'Affiliation': 'Department of Psychology, Hunter College of the City University of New York (CUNY), New York, NY, United States.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Cabral', 'Affiliation': 'Department of Psychology, Hunter College of the City University of New York (CUNY), New York, NY, United States.'}]",JMIR research protocols,['10.2196/19701'] 1219,32782818,Pediatric size phlebotomy tubes and transfusions in adult critically ill patients: a pilot randomized controlled trial.,"Background Transfusion of red blood cells (RBC) is common, can have adverse effects, and is a costly and limited resource. Interventions that reduce iatrogenic blood losses could reduce transfusions. The objectives of this pilot trial were to assess the feasibility (acceptability of the intervention and suitability of eligibility criteria) and potential effectiveness of pediatric size phlebotomy tubes in adult critically ill patients. Methods We conducted a pilot, randomized controlled trial in the medical intensive care unit (ICU) of a university-affiliated, tertiary care referral hospital from November 2017 to September 2018. A total of 200 patients with hemoglobin of at least 7 g/dL and without bleeding were randomized to pediatric or adult size phlebotomy tubes. Stratification was according to baseline hemoglobin (7-9.49 g/dL, 9.5-11.99 g/dL, and 12 g/dL or greater). Acceptability was measured via the number of blood test recollections and the number of patients that discontinued the use of pediatric tubes. The suitability of patient eligibility criteria was determined by identifying baseline characteristics associated with RBC transfusions. Potential effectiveness was estimated from the time to RBC transfusion or to hemoglobin level below 7 g/dL. Results The use of pediatric tubes was acceptable as patients experienced a low number of tests recollections (on average 1 every 57 days), and none of the participants discontinued their use. The baseline hemoglobin category was the only factor that appeared to be independently associated with RBC transfusions. A total of 6 patients (6%) in the pediatric tube group and 11 patients (11%) in the adult tube group (hazard ratio, 0.69; 95% CI, 0.25 to 1.9) received an RBC transfusion or reached hemoglobin below 7 g/dL. Almost all of these patients (16 of 17 participants) had baseline hemoglobin of 7-9.49 g/dL. Conclusions This pilot study suggests that pediatric phlebotomy tubes are acceptable to patients and can therefore be used in adult ICU patients. A future study should focus on patients with hemoglobin levels below 9.5 g/dL, as these patients have a high risk of transfusions. This intervention has the potential of being successful in selected patients. A definitive trial is warranted. Trial registration ClinicalTrials.gov, NCT03286465. Retrospectively registered on September 18, 2017.",2020,Acceptability was measured via the number of blood test recollections and the number of patients that discontinued the use of pediatric tubes.,"['adult ICU patients', 'medical intensive care unit (ICU) of a university-affiliated, tertiary care referral hospital from November 2017 to September 2018', '200 patients with hemoglobin of at least 7\u2009g/dL and without bleeding', 'patients with hemoglobin levels below 9.5\u2009g/dL, as these patients have a high risk of transfusions', 'adult critically ill patients']","['pediatric or adult size phlebotomy tubes', 'Pediatric size phlebotomy tubes and transfusions', 'pediatric size phlebotomy tubes']","['Acceptability', 'RBC transfusion or reached hemoglobin', 'iatrogenic blood losses', 'Potential effectiveness', 'baseline hemoglobin']","[{'cui': 'C0587445', 'cui_str': 'Adult intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2711734', 'cui_str': 'Medical intensive care unit'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0190979', 'cui_str': 'Phlebotomy'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0086252', 'cui_str': 'Transfusion of red blood cells'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",200.0,0.204252,Acceptability was measured via the number of blood test recollections and the number of patients that discontinued the use of pediatric tubes.,"[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Barreda Garcia', 'Affiliation': 'Division of Critical Care Medicine, Department of Internal Medicine, The University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 1.434, Houston, TX 77030 USA.'}, {'ForeName': 'Jonathan Z', 'Initials': 'JZ', 'LastName': 'Xian', 'Affiliation': 'Division of Critical Care Medicine, Department of Internal Medicine, The University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 1.434, Houston, TX 77030 USA.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pedroza', 'Affiliation': 'Center for Clinical Research and Evidence-Based Medicine, The University of Texas Health Science Center at Houston, Houston, TX USA.'}, {'ForeName': 'Moiz', 'Initials': 'M', 'LastName': 'Salahuddin', 'Affiliation': 'Division of Critical Care Medicine, Department of Internal Medicine, The University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 1.434, Houston, TX 77030 USA.'}, {'ForeName': 'Garbo', 'Initials': 'G', 'LastName': 'Mak', 'Affiliation': 'Division of Critical Care Medicine, Department of Internal Medicine, The University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 1.434, Houston, TX 77030 USA.'}, {'ForeName': 'Anabelle', 'Initials': 'A', 'LastName': 'Keene', 'Affiliation': 'Memorial Hermann Hospital Texas Medical Center, Houston, TX USA.'}, {'ForeName': 'Sujith V', 'Initials': 'SV', 'LastName': 'Cherian', 'Affiliation': 'Division of Critical Care Medicine, Department of Internal Medicine, The University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 1.434, Houston, TX 77030 USA.'}, {'ForeName': 'Alisha Y', 'Initials': 'AY', 'LastName': 'Young', 'Affiliation': 'Division of Critical Care Medicine, Department of Internal Medicine, The University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 1.434, Houston, TX 77030 USA.'}, {'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Vijhani', 'Affiliation': 'Division of Critical Care Medicine, Department of Internal Medicine, The University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 1.434, Houston, TX 77030 USA.'}, {'ForeName': 'Pratik B', 'Initials': 'PB', 'LastName': 'Doshi', 'Affiliation': 'Division of Critical Care Medicine, Department of Internal Medicine, The University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 1.434, Houston, TX 77030 USA.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00657-3'] 1220,32787944,Resident-to-resident elder mistreatment (R-REM) intervention for direct care staff in assisted living residences: study protocol for a cluster randomized controlled trial.,"BACKGROUND Resident-to-resident elder mistreatment (R-REM) is defined as negative and aggressive physical, sexual, or verbal interactions between (long-term care) residents that in a community setting would likely be construed as unwelcome and have high potential to cause physical and/or psychological harm and distress. R-REM has been established as a serious problem that has a negative impact on the safety, physical well-being, and quality-of-life of residents living in nursing homes. Although there are no in-depth studies, there is evidence that it is prevalent in assisted living residences and associated with a variety of person, environmental, and facility characteristics. The authors conducted the first systematic, prospective study of resident-to-resident elder mistreatment in nursing homes and developed an intervention for direct care staff to enhance knowledge of R-REM and increase reporting and resident safety by reducing falls and associated injuries. The study aim was to examine the effects of this intervention in assisted living residences. The primary distal outcome is falls and injuries, and the key process outcomes are staff knowledge and reporting. METHODS Twelve larger licensed assisted living residences with special care dementia units in two New York State regions will be enrolled on a rolling basis and randomized to intervention or usual care. Data derived from five sources, (1) resident interviews, (2) staff informants, (3) observational data, (4) chart, and (5) incident/accident report data, will be collected at baseline and 6 and 12 months with respect to 1050 residents (750 ""downstate"" and 300 ""upstate""). The intervention is three training modules delivered on-site after baseline data collection for front line staff on all shifts in facilities randomized to the intervention. Modules relate to recognition, management, and reporting of resident-to-resident elder mistreatment. DISCUSSION Given the movement toward alternative congregate living arrangements for older individuals with significant comorbidities, including cognitive impairment; it is critical to enhance resident safety measured by falls, accidents, and injuries and staff knowledge related to recognition, reporting, and treatment of resident-to-resident aggressive and related negative interactions in such settings. This project is important in developing approaches for ameliorating and preventing R-REM in assisted living residences and enhancing resident safety and quality of life. TRIAL REGISTRATION ClinicalTrials.gov NCT03383289 . Registered on 26 December 2017.",2020,The intervention is three training modules delivered on-site after baseline data collection for front line staff on all shifts in facilities randomized to the intervention.,"['assisted living residences', 'Twelve larger licensed assisted living residences with special care dementia units in two New York State regions will be enrolled on a rolling basis and randomized to intervention or usual care', 'older individuals with significant comorbidities, including cognitive impairment']",['Resident-to-resident elder mistreatment (R-REM) intervention'],"['falls and injuries, and the key process outcomes are staff knowledge and reporting']","[{'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0623181,The intervention is three training modules delivered on-site after baseline data collection for front line staff on all shifts in facilities randomized to the intervention.,"[{'ForeName': 'Jeanne A', 'Initials': 'JA', 'LastName': 'Teresi', 'Affiliation': 'Research Division, Hebrew Home at Riverdale, Bronx, NY, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Silver', 'Affiliation': 'Research Division, Hebrew Home at Riverdale, Bronx, NY, USA. sasilver98@aol.com.'}, {'ForeName': 'Mildred', 'Initials': 'M', 'LastName': 'Ramirez', 'Affiliation': 'Research Division, Hebrew Home at Riverdale, Bronx, NY, USA.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Kong', 'Affiliation': 'Research Division, Hebrew Home at Riverdale, Bronx, NY, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Eimicke', 'Affiliation': 'Research Division, Hebrew Home at Riverdale, Bronx, NY, USA.'}, {'ForeName': 'Gabriel D', 'Initials': 'GD', 'LastName': 'Boratgis', 'Affiliation': 'Research Division, Hebrew Home at Riverdale, Bronx, NY, USA.'}, {'ForeName': 'Rhoda', 'Initials': 'R', 'LastName': 'Meador', 'Affiliation': 'Bronfenbrenner Center for Translational Research, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Schultz', 'Affiliation': 'College of Human Ecology, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Lachs', 'Affiliation': 'Division of Geriatrics and Palliative Medicine, The Weill Medical College of Cornell University, New York, NY, USA.'}, {'ForeName': 'Karl A', 'Initials': 'KA', 'LastName': 'Pillemer', 'Affiliation': 'Division of Geriatrics and Palliative Medicine, The Weill Medical College of Cornell University, New York, NY, USA.'}]",Trials,['10.1186/s13063-020-04580-z'] 1221,32789530,Bag-of-features-based radiomics for differentiation of ocular adnexal lymphoma and idiopathic orbital inflammation from contrast-enhanced MRI.,"OBJECTIVES To evaluate the effectiveness of bag-of-features (BOF)-based radiomics for differentiating ocular adnexal lymphoma (OAL) and idiopathic orbital inflammation (IOI) from contrast-enhanced MRI (CE-MRI). METHODS Fifty-six patients with pathologically confirmed IOI (28 patients) and OAL (28 patients) were randomly divided into training (n = 42) and testing (n = 14) groups. One hundred sixty texture features extracted from the CE-MR image were encoded into the BOF representation with fewer features. The support vector machine (SVM) with a linear kernel was used as the classifier. Data augmented was performed by cropping orbital lesions in different directions to alleviate the over-fitting problem. Student's t test and the Holm-Bonferroni method were employed to compare the performance of different analysis methods. The chi-square test was used to compare the analysis with MRI and human radiological diagnosis. RESULTS In the independent testing group, the differentiation by the BOF features with augmentation achieved an area under the curve (AUC) of 0.803 (95% CI: 0.725-0.880), which was significantly higher than that of the BOF features without augmentation and that of the texture features (p < 0.05). In addition, the same radiomic analysis with pre-contrast MRI obtained an AUC of 0.618 (95% CI: 0.560-0.677), which was significantly lower than that with CE-MRI. The diagnostic performance of the analysis with CE-MRI was significantly better than the radiology resident (p < 0.05) but had no significant difference with the experienced radiologist, even though there was less consistency between the radiomic analysis and the human visual diagnosis. CONCLUSIONS The BOF-based radiomics may be helpful for the differentiation between OAL and IOI. KEY POINTS • It is challenging to differentiate OAL from IOI due to the similar clinical and image features. • Radiomics has great potential for the noninvasive diagnosis of orbital diseases. • The BOF representation from patch to image may help the differentiation of OAL and IOI.",2021,"The diagnostic performance of the analysis with CE-MRI was significantly better than the radiology resident (p < 0.05) but had no significant difference with the experienced radiologist, even though there was less consistency between the radiomic analysis and the human visual diagnosis. ",['Fifty-six patients with pathologically confirmed IOI (28 patients) and OAL (28 patients'],['bag-of-features (BOF)-based radiomics'],['BOF features with augmentation achieved an area under the curve (AUC'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0085270', 'cui_str': 'Inflammatory pseudotumor of orbit'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0024299', 'cui_str': 'Malignant lymphoma'}]","[{'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",56.0,0.0345749,"The diagnostic performance of the analysis with CE-MRI was significantly better than the radiology resident (p < 0.05) but had no significant difference with the experienced radiologist, even though there was less consistency between the radiomic analysis and the human visual diagnosis. ","[{'ForeName': 'Yuqing', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': ""School of Information Science and Technology, Northwest University, Xi'an, 710069, Shaanxi, China.""}, {'ForeName': 'Xiaoyang', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': ""School of Information Science and Technology, Northwest University, Xi'an, 710069, Shaanxi, China.""}, {'ForeName': 'Jixin', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""School of Information Science and Technology, Northwest University, Xi'an, 710069, Shaanxi, China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Lv', 'Affiliation': ""Department of Radiology, Xi'an Fourth Hospital, Xi'an, 710004, Shaanxi, China.""}, {'ForeName': 'Shijie', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': ""Department of Radiology, Xi'an Fourth Hospital, Xi'an, 710004, Shaanxi, China.""}, {'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'He', 'Affiliation': ""School of Information Science and Technology, Northwest University, Xi'an, 710069, Shaanxi, China.""}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""Department of Radiology, Xi'an Fourth Hospital, Xi'an, 710004, Shaanxi, China. ylijuan@126.com.""}, {'ForeName': 'Fengjun', 'Initials': 'F', 'LastName': 'Zhao', 'Affiliation': ""School of Information Science and Technology, Northwest University, Xi'an, 710069, Shaanxi, China. fjzhao@nwu.edu.cn.""}]",European radiology,['10.1007/s00330-020-07110-2'] 1222,32796016,Does the Spraino low-friction shoe patch prevent lateral ankle sprain injury in indoor sports? A pilot randomised controlled trial with 510 participants with previous ankle injuries.,"BACKGROUND Lateral ankle sprains are common in indoor sports. High shoe-surface friction is considered a risk factor for non-contact lateral ankle sprains. Spraino is a novel low-friction patch that can be attached to the outside of sports shoes to minimise friction at the lateral edge, which could mitigate the risk of such injury. We aimed to determine preliminary effectiveness (incidence rate and severity) and safety (harms) of Spraino to prevent lateral ankle sprains among indoor sport athletes. METHODS In this exploratory, parallel-group, two-arm pilot randomised controlled trial, 510 subelite indoor sport athletes with a previous lateral ankle sprain were randomly allocated (1:1) to Spraino or 'do-as-usual'. Allocation was concealed and the trial was outcome assessor blinded. Match and training exposure, number of injuries and associated time loss were captured weekly via text messages. Information on harms, fear-of-injury and ankle pain was also documented. RESULTS 480 participants completed the trial. They reported a total of 151 lateral ankle sprains, of which 96 were categorised as non-contact, and 50 as severe. All outcomes favoured Spraino with incidence rate ratios of 0.87 (95% CI 0.62 to 1.23) for all lateral ankle sprains; 0.64 (95% CI 0.42 to 0.98) for non-contact lateral ankle sprains; and 0.47 (95% CI 0.25 to 0.88) for severe lateral ankle sprains. Time loss per injury was also lower in the Spraino group (1.8 vs 2.8 weeks, p=0.014). Six participants reported minor harms because of Spraino. CONCLUSION Compared with usual care, athletes allocated to Spraino had a lower risk of lateral ankle sprains and less time loss, with only few reported minor harms. TRIAL REGISTRATION NUMBER NCT03311490.",2021,"Compared with usual care, athletes allocated to Spraino had a lower risk of lateral ankle sprains and less time loss, with only few reported minor harms. ","['480 participants completed the trial', '510 participants with previous ankle injuries', 'lateral ankle sprains among indoor sport athletes', '510 subelite indoor sport athletes with a previous lateral ankle sprain']","[""Spraino or 'do-as-usual"", 'Spraino']","['incidence rate ratios', 'Time loss per injury', 'risk of lateral ankle sprains and less time loss', 'harms, fear-of-injury and ankle pain', 'Match and training exposure, number of injuries and associated time loss', 'severe lateral ankle sprains']","[{'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517800', 'cui_str': '510'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0085111', 'cui_str': 'Injury of ankle'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0160087', 'cui_str': 'Sprain of ankle'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]",[],"[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0160087', 'cui_str': 'Sprain of ankle'}, {'cui': 'C2874943', 'cui_str': 'Fear of injury'}, {'cui': 'C0238656', 'cui_str': 'Ankle pain'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",510.0,0.302455,"Compared with usual care, athletes allocated to Spraino had a lower risk of lateral ankle sprains and less time loss, with only few reported minor harms. ","[{'ForeName': 'Filip Gertz', 'Initials': 'FG', 'LastName': 'Lysdal', 'Affiliation': 'Department of Health Science and Technology, Sport Sciences, Aalborg University, Aalborg, Denmark fgly@hst.aau.dk.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bandholm', 'Affiliation': 'Department of Physical and Occupational Therapy, Physical Medicine and Rehabilitation Research-Copenhagen, Amager-Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Janne Schurmann', 'Initials': 'JS', 'LastName': 'Tolstrup', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Copenhagen, Denmark.'}, {'ForeName': 'Mikkel Bek', 'Initials': 'MB', 'LastName': 'Clausen', 'Affiliation': 'Department of Orthopedic Surgery, Sports Orthopedic Research Center-Copenhagen, Amager-Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Mann', 'Affiliation': 'Clinical Research Centre, Amager-Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Pelle Baggesgaard', 'Initials': 'PB', 'LastName': 'Petersen', 'Affiliation': 'Section for Surgical Pathophysiology 7621, Rigshospitalet, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Thor Buch', 'Initials': 'TB', 'LastName': 'Grønlykke', 'Affiliation': 'Spraino ApS, Copenhagen, Denmark.'}, {'ForeName': 'Uwe G', 'Initials': 'UG', 'LastName': 'Kersting', 'Affiliation': 'Department of Health Science and Technology, Sport Sciences, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Eamonn', 'Initials': 'E', 'LastName': 'Delahunt', 'Affiliation': 'School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Thorborg', 'Affiliation': 'Department of Physical and Occupational Therapy, Physical Medicine and Rehabilitation Research-Copenhagen, Amager-Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.'}]",British journal of sports medicine,['10.1136/bjsports-2019-101767'] 1223,33231352,"Use of color-coded, three-dimensional-printed equine carpus models is preferred by students but does not result in statistically different academic performance.","Radiology can be a challenging subject for students and finding new techniques that help improve their understanding could have positive effects in their clinical practice. The purpose of this prospective experimental study was to implement the use of color-coded, three-dimensional-printed, handheld equine carpus models into a radiographic anatomy course and evaluate the impact objectively and subjectively using quizzes and student response surveys. A first-year veterinary class was randomly divided into two similarly sized groups (groups A and B) for an equine normal radiographic anatomy laboratory. Both groups experienced the same laboratory structure; however, each student in group B received a handheld three-dimensional-printed equine carpus. Both groups received a quiz at the end of their laboratory consisting of 10 multiple-choice questions related to the equine carpus. An anonymous survey regarding the laboratory was emailed to students after the laboratory. One week later, the same 10 questions in randomized order were administered via a pop-quiz. Students believed both quizzes would count toward their final course grade. There was no statistically significant difference in grades between groups on either quiz (P > .05). However, based on survey responses, group B students felt the carpus made the laboratory more enjoyable and improved their comprehension of the material, whereas group A students felt the carpus would have increased their enjoyment and improved their comprehension. The implementation of three-dimensional-printed anatomic models may be useful to enhance enjoyment and perceived comprehension of veterinary students; however, there is currently insufficient evidence to suggest these models improve academic performance.",2021,"The implementation of three-dimensional-printed anatomic models may be useful to enhance enjoyment and perceived comprehension of veterinary students; however, there is currently insufficient evidence to suggest these models improve academic performance.",[],['handheld three-dimensional-printed equine carpus'],[],[],"[{'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0019944', 'cui_str': 'Equus caballus'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}]",[],,0.0146447,"The implementation of three-dimensional-printed anatomic models may be useful to enhance enjoyment and perceived comprehension of veterinary students; however, there is currently insufficient evidence to suggest these models improve academic performance.","[{'ForeName': 'Kryssa L', 'Initials': 'KL', 'LastName': 'Johnson', 'Affiliation': 'Small Animal Clinical Sciences, College of Veterinary Medicine, University of Tennessee, Knoxville, Tennessee.'}, {'ForeName': 'Adrien-Maxence', 'Initials': 'AM', 'LastName': 'Hespel', 'Affiliation': 'Small Animal Clinical Sciences, College of Veterinary Medicine, University of Tennessee, Knoxville, Tennessee.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Price', 'Affiliation': 'Office of Information Technology, University of Tennessee, Knoxville, Tennessee.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'de Swarte', 'Affiliation': 'Small Animal Clinical Sciences, College of Veterinary Medicine, University of Tennessee, Knoxville, Tennessee.'}]",Veterinary radiology & ultrasound : the official journal of the American College of Veterinary Radiology and the International Veterinary Radiology Association,['10.1111/vru.12929'] 1224,32803824,Interoceptive signaling in alcohol cognitive biases: Role of family history and alliesthetic components.,"The role of interoceptive signals in the development of cognitive biases for drug-related cues has been hypothesized in the past; however, experimental evidence is lacking. This report examined the relationship between physiological responses and memories for alcohol cues. Participants (n = 158) were categorized as having either a positive or negative family history of alcohol use disorder (AUD). They were assigned to an alcohol, placebo, or control beverage condition to which they were blinded. All participants were presented with alcohol, neutral, and emotional cues. Heart rate variability (HRV) at 0.1 Hz, as an index of viscero-afferent reactivity, and in the high-frequency range was measured during picture-cue exposure. Participants then completed free recall and repetition priming tasks to assess memories for previously presented stimuli. Participants with a positive family history (FHP) for AUD who received an alcohol beverage displayed a positive relationship between 0.1 Hz HRV and free recall. This effect was specific to alcohol cues, highlighting the relevance of physiological signals in the development of alcohol cognitive biases. These results support the hypothesis of a coordinated brain-body interaction in the development of drug-related behaviors. FHP as an AUD risk factor may increase the mapping of physiological responses onto cognitive biases for alcohol cues. Increased ratings of subjective intoxication dampened this relationship, suggesting that perceived bodily states may modulate incentive salience processes. This report provides novel evidence for the involvement of interoceptive signals in addictive processes, setting a precedent for the exploration of brain-body interactions in the study of alcohol cognitive biases.",2021,Participants with a positive family history (FHP) for AUD who received an alcohol beverage displayed a positive relationship between 0.1 Hz HRV and free recall.,"['Participants with a positive family history (FHP) for AUD who received an', 'Participants (n = 158) were categorized as having either a positive or negative family history of alcohol use disorder (AUD', 'All participants were presented with alcohol, neutral, and emotional cues']","['alcohol, placebo', 'alcohol beverage']",['Heart rate variability (HRV'],"[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0241889', 'cui_str': 'Family history of clinical finding'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0476560', 'cui_str': 'Family history of alcohol abuse'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}]",158.0,0.0457924,Participants with a positive family history (FHP) for AUD who received an alcohol beverage displayed a positive relationship between 0.1 Hz HRV and free recall.,"[{'ForeName': 'Mateo', 'Initials': 'M', 'LastName': 'Leganes-Fonteneau', 'Affiliation': 'Department of Kinesiology and Health, Rutgers University-New Brunswick, New Brunswick, New Jersey, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Buckman', 'Affiliation': 'Department of Kinesiology and Health, Rutgers University-New Brunswick, New Brunswick, New Jersey, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Pawlak', 'Affiliation': 'Department of Kinesiology and Health, Rutgers University-New Brunswick, New Brunswick, New Jersey, USA.'}, {'ForeName': 'Bronya', 'Initials': 'B', 'LastName': 'Vaschillo', 'Affiliation': 'Department of Kinesiology and Health, Rutgers University-New Brunswick, New Brunswick, New Jersey, USA.'}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Vaschillo', 'Affiliation': 'Department of Kinesiology and Health, Rutgers University-New Brunswick, New Brunswick, New Jersey, USA.'}, {'ForeName': 'Marsha', 'Initials': 'M', 'LastName': 'Bates', 'Affiliation': 'Department of Kinesiology and Health, Rutgers University-New Brunswick, New Brunswick, New Jersey, USA.'}]",Addiction biology,['10.1111/adb.12952'] 1225,32798723,"Addition of Lidocaine to the Distension Medium in Hysteroscopy Decreases Pain during the Procedure-A Randomized Double-blind, Placebo-controlled Trial.","STUDY OBJECTIVE To evaluate the effect of adding a local anesthetic to the distension medium in office diagnostic hysteroscopy using the vaginoscopic approach on pain during the procedure. Secondary aims included documenting side effects, patient satisfaction, and the time needed to complete the procedure. DESIGN Randomized double-blind placebo-controlled study. SETTING University-affiliated hospital; office hysteroscopy clinic. PATIENTS Total of 100 patients who underwent office hysteroscopies divided in half with 50 in the intervention group and 50 in the control group. INTERVENTIONS Ten mL of lidocaine 2% added to 1000 mL of saline solution that was used as the distension medium for hysteroscopy in the study group vs 1000 mL of saline alone in the control group. MEASUREMENTS AND MAIN RESULTS A significant difference was found in the increment of pain as measured by visual analog scale after the hysteroscopy between the 2 groups. Patients receiving lidocaine had an average rise of 1.9 in the visual analog scale score after the procedure compared with 2.9 in the control group (p = .033). There was also a nonsignificant trend for shorter duration of hysteroscopy in the intervention group compared with the control group (180.1 vs 222.1 seconds, p = .08). Patients' satisfaction was high in both groups (98% for the study group and 92% for the control group). Success rates were also similar between the 2 groups at approximately 95%. No side effects were recorded in either group. CONCLUSION The addition of local anesthetic to the distension medium in office hysteroscopy produces significant reduction in pain during the procedure without adding time to the procedure and without side effects.",2021,"There was also a non-significant trend for shorter duration of hysteroscopy in the intervention group compared to the control group (180.1 vs. 222.1 seconds, P= 0.08).",['100 patients that underwent office hysteroscopy divided to 50 in the intervention group and 50 in the control group'],"['Lidocaine', 'lidocaine', 'lidocaine 2% added into 1000 ml of saline solution', 'saline alone in the control group', 'placebo']","['increment of pain', 'side effects, patient satisfaction and the time needed to complete the procedure', 'VAS score', 'Pain', 'success rates', 'shorter duration of hysteroscopy', 'pain', 'Visual Analogue Scale (VAS', 'Patients satisfaction', 'side effects']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.213792,"There was also a non-significant trend for shorter duration of hysteroscopy in the intervention group compared to the control group (180.1 vs. 222.1 seconds, P= 0.08).","[{'ForeName': 'Oshri', 'Initials': 'O', 'LastName': 'Barel', 'Affiliation': ""Department of Obstetrics and Gynecology, Samson Assuta Ashdod University Hospital, Ashdod and Faculty of Health Sciences, Ben Gurion University of the Negev, Be'er Sheva, Israel (all authors).. Electronic address: barelod@gmail.com.""}, {'ForeName': 'Elad', 'Initials': 'E', 'LastName': 'Preuss', 'Affiliation': ""Department of Obstetrics and Gynecology, Samson Assuta Ashdod University Hospital, Ashdod and Faculty of Health Sciences, Ben Gurion University of the Negev, Be'er Sheva, Israel (all authors).""}, {'ForeName': 'Natan', 'Initials': 'N', 'LastName': 'Stolovitch', 'Affiliation': ""Department of Obstetrics and Gynecology, Samson Assuta Ashdod University Hospital, Ashdod and Faculty of Health Sciences, Ben Gurion University of the Negev, Be'er Sheva, Israel (all authors).""}, {'ForeName': 'Shiri', 'Initials': 'S', 'LastName': 'Weinberg', 'Affiliation': ""Department of Obstetrics and Gynecology, Samson Assuta Ashdod University Hospital, Ashdod and Faculty of Health Sciences, Ben Gurion University of the Negev, Be'er Sheva, Israel (all authors).""}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Barzilay', 'Affiliation': ""Department of Obstetrics and Gynecology, Samson Assuta Ashdod University Hospital, Ashdod and Faculty of Health Sciences, Ben Gurion University of the Negev, Be'er Sheva, Israel (all authors).""}, {'ForeName': 'Moty', 'Initials': 'M', 'LastName': 'Pansky', 'Affiliation': ""Department of Obstetrics and Gynecology, Samson Assuta Ashdod University Hospital, Ashdod and Faculty of Health Sciences, Ben Gurion University of the Negev, Be'er Sheva, Israel (all authors).""}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2020.08.003'] 1226,32800613,Re: Prajna et al.: Cross-Linking-Assisted Infection Reduction: a randomized clinical trial evaluating the effect of adjuvant cross-linking on outcomes in fungal keratitis (Ophthalmology. 2020;127:159-166).,,2021,,['fungal keratitis (Ophthalmology'],"[' Cross-Linking-Assisted Infection Reduction', 'adjuvant cross-linking']",[],"[{'cui': 'C1262117', 'cui_str': 'Fungal keratitis'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}]","[{'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]",[],,0.139189,,"[{'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Hafezi', 'Affiliation': 'Laboratory for Ocular Cell Biology, Center for Applied Biotechnology and Molecular Medicine, University of Zurich, Switzerland; ELZA Institute, Dietikon, Switzerland; USC Roski Eye Institute, University of Southern California, Los Angeles, California; Faculty of Medicine, University of Geneva, Geneva, Switzerland; Department of Ophthalmology, University of Wenzhou, Wenzhou, China. Electronic address: farhad@hafezi.ch.'}, {'ForeName': 'Emilio A', 'Initials': 'EA', 'LastName': 'Torres-Netto', 'Affiliation': 'Laboratory for Ocular Cell Biology, Center for Applied Biotechnology and Molecular Medicine, University of Zurich, Switzerland; ELZA Institute, Dietikon, Switzerland; Department of Ophthalmology, Paulista School of Medicine, Federal University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Mark J P', 'Initials': 'MJP', 'LastName': 'Hillen', 'Affiliation': 'ELZA Institute, Dietikon, Switzerland.'}]",Ophthalmology,['10.1016/j.ophtha.2020.07.011'] 1227,32805028,Avocado Consumption Alters Gastrointestinal Bacteria Abundance and Microbial Metabolite Concentrations among Adults with Overweight or Obesity: A Randomized Controlled Trial.,"BACKGROUND Avocados are rich in dietary fiber and monounsaturated fatty acids (MUFAs), nutrients that have been independently connected to metabolic health benefits and the gastrointestinal microbiota. OBJECTIVES We aimed to evaluate the impact of avocado consumption on the gastrointestinal microbiota and microbial metabolites, secondary outcomes of the Persea americana for Total Health (PATH) study, and conduct exploratory analyses to assess relations between the fecal microbiota, fecal metabolites, and health markers. METHODS Adults [n = 163, 25-45 y, BMI (kg/m2) ≥ 25.0] were enrolled in the PATH study, a 12-wk investigator-blinded trial where participants were batch randomized to match the 2 groups by age, sex, visceral adiposity, and fasting glucose concentrations. Participants consumed isocaloric meals with or without avocado (175 g, men; 140 g, women) once daily for 12 wk. The fecal microbiota was assessed with 16S ribosomal RNA gene (V4 region) sequencing and analysis using DADA2 and QIIME2. Fecal fatty acid and bile acid concentrations were quantified using GC and LC-MS. Per-protocol (≥80% meal consumption) and intent-to-treat analyses were conducted using univariate ANOVA and Mann-Whitney U tests. Bivariate correlations were conducted between fecal microbiota, fecal metabolites, and health measures. RESULTS The avocado treatment increased ɑ diversity and enriched Faecalibacterium, Lachnospira, and Alistipes between 26% and 65% compared with the control group. The avocado group had 18% greater fecal acetate, 70% greater stearic acid, and 98% greater palmitic acid concentrations than the control group, while the concentrations of the bile acids cholic and chenodeoxycholic acid were 91% and 57% lower, respectively. CONCLUSIONS Daily avocado consumption resulted in lower fecal bile acid concentrations, greater fecal fatty acid and SCFAs, and greater relative abundances of bacteria capable of fiber fermentation, providing evidence that this nutrient-dense food affects digestive physiology, as well as the composition and metabolic functions of the intestinal microbiota. This trial was registered at www.clinicaltrials.gov as NCT02740439.",2021,"The avocado treatment increased ɑ diversity and enriched Faecalibacterium, Lachnospira, and Alistipes between 26% and 65% compared with the control group.","['163, 25-45 y, BMI (kg/m2', 'Adults with Overweight or Obesity', 'Adults [n\xa0']","['avocado consumption', 'Avocado Consumption', 'isocaloric meals with or without avocado']","['Gastrointestinal Bacteria Abundance and Microbial Metabolite Concentrations', 'Fecal fatty acid and bile acid concentrations', 'fecal bile acid concentrations, greater fecal fatty acid and SCFAs', 'fecal microbiota', 'fecal acetate', 'palmitic acid concentrations', 'fecal microbiota, fecal metabolites, and health measures', 'ɑ diversity and enriched Faecalibacterium, Lachnospira, and Alistipes', 'bile acids cholic and chenodeoxycholic acid', 'fecal microbiota, fecal metabolites, and health markers']","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0330230', 'cui_str': 'Avocado'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0030234', 'cui_str': 'Palmitic acid'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1229075', 'cui_str': 'Faecalibacterium'}, {'cui': 'C0317586', 'cui_str': 'Lachnospira'}, {'cui': 'C1490417', 'cui_str': 'Alistipes'}, {'cui': 'C0008024', 'cui_str': 'chenodeoxycholic acid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.176713,"The avocado treatment increased ɑ diversity and enriched Faecalibacterium, Lachnospira, and Alistipes between 26% and 65% compared with the control group.","[{'ForeName': 'Sharon V', 'Initials': 'SV', 'LastName': 'Thompson', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois, Urbana-Champaign, IL, USA.'}, {'ForeName': 'Melisa A', 'Initials': 'MA', 'LastName': 'Bailey', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois, Urbana-Champaign, IL, USA.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Taylor', 'Affiliation': 'Department of Food Science and Human Nutrition, University of Illinois, Urbana-Champaign, IL, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Kaczmarek', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois, Urbana-Champaign, IL, USA.'}, {'ForeName': 'Annemarie R', 'Initials': 'AR', 'LastName': 'Mysonhimer', 'Affiliation': 'Department of Food Science and Human Nutrition, University of Illinois, Urbana-Champaign, IL, USA.'}, {'ForeName': 'Caitlyn G', 'Initials': 'CG', 'LastName': 'Edwards', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois, Urbana-Champaign, IL, USA.'}, {'ForeName': 'Ginger E', 'Initials': 'GE', 'LastName': 'Reeser', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois, Urbana-Champaign, IL, USA.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Burd', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois, Urbana-Champaign, IL, USA.'}, {'ForeName': 'Naiman A', 'Initials': 'NA', 'LastName': 'Khan', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois, Urbana-Champaign, IL, USA.'}, {'ForeName': 'Hannah D', 'Initials': 'HD', 'LastName': 'Holscher', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois, Urbana-Champaign, IL, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa219'] 1228,32807113,"The efficacy of a leukotriene receptor antagonist in the treatment of human rectal aberrant crypt foci: a nonrandomized, open-label, controlled trial.","BACKGROUND Leukotriene receptor antagonists (LTRAs) are broadly used for the management of allergic asthma and have recently been indicated to inhibit carcinogenesis and cancer cell growth. In colorectal cancer (CRC) chemoprevention studies, the occurrence of adenoma or CRC itself is generally set as the trial endpoint. Although the occurrence rate of CRC is the most confident endpoint, it is inappropriate for chemoprevention studies because CRC incidence rate is low in the general population and needed for long-term monitoring. Aberrant crypt foci (ACF), defined as lesions containing crypts that are larger in diameter and darker in methylene blue staining than normal crypts, are regarded to be a fine surrogate biomarker of CRC. Therefore, this prospective study was designed to explore the chemopreventive effect of LTRA on colonic ACF formation and the safety of the medicine in patients scheduled for a poly resection as a pilot trial leading the CRC chemoprevention trial. METHODS This study is a nonrandomized, open-label, controlled trial in patients with colorectal ACF and polyps scheduled for a polypectomy. Participants meet the inclusion criteria will be recruited, and the number of ACF in the rectum will be counted at the baseline colonoscopic examination. Next, the participants will be assigned to the LTRA or no treatment group. Participants in the LTRA group will continue 10 mg of oral montelukast for 8 weeks, and those in the no treatment group will be observed without the administration of any additional drugs. At the end of the 8-week LTRA intervention period, a polypectomy will be conducted to evaluate the changes in the number of ACF, and cell proliferation in the normal colorectal epithelium will be analyzed. DISCUSSION This will be the first study to investigate the effect of LTRAs on colorectal ACF formation in humans. TRIAL REGISTRATION This trial has been registered in the University Hospital Medical Information Network (UMIN) Clinical Trials Registry as UMIN000029926 . Registered 10 November 2017.",2020,"Aberrant crypt foci (ACF), defined as lesions containing crypts that are larger in diameter and darker in methylene blue staining than normal crypts, are regarded to be a fine surrogate biomarker of CRC.","['humans', 'patients scheduled for a poly resection as a pilot trial leading the CRC chemoprevention trial', 'patients with colorectal ACF and polyps scheduled for a polypectomy', 'University Hospital Medical Information Network (UMIN', 'human rectal aberrant crypt foci']","['LTRA', 'Leukotriene receptor antagonists (LTRAs', 'leukotriene receptor antagonist', 'oral montelukast', 'LTRAs']","['colonic ACF formation', 'Aberrant crypt foci (ACF']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0032400', 'cui_str': 'Poly(rA)'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0282515', 'cui_str': 'Prophylactic chemotherapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C1879526', 'cui_str': 'Aberrant Crypt Foci'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021419', 'cui_str': 'Information Networks'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}]","[{'cui': 'C0595726', 'cui_str': 'Leukotriene receptor antagonist'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0298130', 'cui_str': 'montelukast'}]","[{'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C1879526', 'cui_str': 'Aberrant Crypt Foci'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",,0.0512029,"Aberrant crypt foci (ACF), defined as lesions containing crypts that are larger in diameter and darker in methylene blue staining than normal crypts, are regarded to be a fine surrogate biomarker of CRC.","[{'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Higurashi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa, Yokohama, Kanagawa, 236-0004, Japan. takuma_h@yokohama-cu.ac.jp.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Arimoto', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa, Yokohama, Kanagawa, 236-0004, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Ashikari', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa, Yokohama, Kanagawa, 236-0004, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Takatsu', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa, Yokohama, Kanagawa, 236-0004, Japan.'}, {'ForeName': 'Noboru', 'Initials': 'N', 'LastName': 'Misawa', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa, Yokohama, Kanagawa, 236-0004, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Yoshihara', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa, Yokohama, Kanagawa, 236-0004, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Matsuura', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa, Yokohama, Kanagawa, 236-0004, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Fuyuki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa, Yokohama, Kanagawa, 236-0004, Japan.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Ohkubo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa, Yokohama, Kanagawa, 236-0004, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nakajima', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa, Yokohama, Kanagawa, 236-0004, Japan.'}]",BMC cancer,['10.1186/s12885-020-07266-6'] 1229,32813887,Exploring novel systemic biomarker approaches in grass-pollen sublingual immunotherapy using omics.,"BACKGROUND Sublingual allergen-specific immunotherapy (SLIT) intervention improves the control of grass pollen allergy by maintaining allergen tolerance after cessation. Despite its widespread use, little is known about systemic effects and kinetics associated to SLIT, as well as the influence of the patient sensitization phenotype (Mono- or Poly-sensitized). In this quest, omics sciences could help to gain new insights to understand SLIT effects. METHODS 47 grass-pollen-allergic patients were enrolled in a double-blind, placebo-controlled, multicenter trial using GRAZAX® during 2 years. Immunological assays (sIgE, sIgG4, and ISAC) were carried out to 31 patients who finished the trial. Additionally, serum and PBMCs samples were analyzed by metabolomics and transcriptomics, respectively. Based on their sensitization level, 22 patients were allocated in Mono- or Poly-sensitized groups, excluding patients allergic to epithelia. Individuals were compared based on their treatment (Active/Placebo) and sensitization level (Mono/Poly). RESULTS Kinetics of serological changes agreed with those previously described. At two years of SLIT, there are scarce systemic changes that could be associated to improvement in systemic inflammation. Poly-sensitized patients presented a higher inflammation at inclusion, while Mono-sensitized patients presented a reduced activity of mast cells and phagocytes as an effect of the treatment. CONCLUSIONS The most relevant systemic change detected after two years of SLIT was the desensitization of effector cells, which was only detected in Mono-sensitized patients. This change may be related to the clinical improvement, as previously reported, and, together with the other results, may explain why clinical effect is lost if SLIT is discontinued at this point.",2021,"Poli-sensitized patients presented a higher inflammation at inclusion, while Mono-sensitized patients presented a reduced activity of mast cells and phagocytes as an effect of the treatment. ","['31 patients who finished the trial', '47 grass-pollen-allergic patients', '22 patients were allocated in Mono or Poli-sensitized groups, excluding patients allergic to epithelia']","['Placebo) and sensitization level (Mono/Poli', 'GRAZAX®', 'Sublingual allergen-specific immunotherapy (SLIT) intervention', 'placebo']","['sIgE, sIgG4 and ISAC', 'serum and PBMCs samples', 'systemic inflammation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0440307', 'cui_str': 'grass pollen'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0032400', 'cui_str': 'Poly(rA)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1325847', 'cui_str': 'Sensitization'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0032400', 'cui_str': 'Poly(rA)'}, {'cui': 'C2935532', 'cui_str': 'Grazax'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",22.0,0.327353,"Poli-sensitized patients presented a higher inflammation at inclusion, while Mono-sensitized patients presented a reduced activity of mast cells and phagocytes as an effect of the treatment. ","[{'ForeName': 'Tomas Clive', 'Initials': 'TC', 'LastName': 'Barker-Tejeda', 'Affiliation': 'Facultad de Farmacia, Centro de Metabolómica y Bioanálisis (CEMBIO), Universidad San Pablo-CEU, CEU Universities, Urbanización Montepríncipe, Madrid, España.'}, {'ForeName': 'Raphaelle', 'Initials': 'R', 'LastName': 'Bazire', 'Affiliation': 'Servicio de Alergia, Instituto de Investigación Sanitaria Princesa (IP), Hospital Universitario de La Princesa, Madrid, España.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Obeso', 'Affiliation': 'Facultad de Farmacia, Centro de Metabolómica y Bioanálisis (CEMBIO), Universidad San Pablo-CEU, CEU Universities, Urbanización Montepríncipe, Madrid, España.'}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Mera-Berriatua', 'Affiliation': 'Facultad de Medicina, Departamento de Ciencias Médicas Básicas, Instituto de Medicina Molecular Aplicada (IMMA), Universidad San Pablo-CEU, CEU Universities, Madrid, España.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Rosace', 'Affiliation': 'Facultad de Medicina, Departamento de Ciencias Médicas Básicas, Instituto de Medicina Molecular Aplicada (IMMA), Universidad San Pablo-CEU, CEU Universities, Madrid, España.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Vazquez-Cortes', 'Affiliation': 'Servicio de Alergia, Hospital Clínico San Carlos, Universidad Complutense, IdISSC, Madrid, España.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Ramos', 'Affiliation': 'Servicio de Alergia, Instituto de Investigación Sanitaria Princesa (IP), Hospital Universitario de La Princesa, Madrid, España.'}, {'ForeName': 'Maria Del Pilar', 'Initials': 'MDP', 'LastName': 'Rico', 'Affiliation': 'Facultad de Medicina, Departamento de Ciencias Médicas Básicas, Instituto de Medicina Molecular Aplicada (IMMA), Universidad San Pablo-CEU, CEU Universities, Madrid, España.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Chivato', 'Affiliation': 'Facultad de Medicina, Departamento de Ciencias Médicas Básicas, Instituto de Medicina Molecular Aplicada (IMMA), Universidad San Pablo-CEU, CEU Universities, Madrid, España.'}, {'ForeName': 'Coral', 'Initials': 'C', 'LastName': 'Barbas', 'Affiliation': 'Facultad de Farmacia, Centro de Metabolómica y Bioanálisis (CEMBIO), Universidad San Pablo-CEU, CEU Universities, Urbanización Montepríncipe, Madrid, España.'}, {'ForeName': 'Alma', 'Initials': 'A', 'LastName': 'Villaseñor', 'Affiliation': 'Facultad de Farmacia, Centro de Metabolómica y Bioanálisis (CEMBIO), Universidad San Pablo-CEU, CEU Universities, Urbanización Montepríncipe, Madrid, España.'}, {'ForeName': 'Maria M', 'Initials': 'MM', 'LastName': 'Escribese', 'Affiliation': 'Facultad de Medicina, Departamento de Ciencias Médicas Básicas, Instituto de Medicina Molecular Aplicada (IMMA), Universidad San Pablo-CEU, CEU Universities, Madrid, España.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Fernández-Rivas', 'Affiliation': 'Servicio de Alergia, Hospital Clínico San Carlos, Universidad Complutense, IdISSC, Madrid, España.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Blanco', 'Affiliation': 'Servicio de Alergia, Instituto de Investigación Sanitaria Princesa (IP), Hospital Universitario de La Princesa, Madrid, España.'}, {'ForeName': 'Domingo', 'Initials': 'D', 'LastName': 'Barber', 'Affiliation': 'Facultad de Medicina, Departamento de Ciencias Médicas Básicas, Instituto de Medicina Molecular Aplicada (IMMA), Universidad San Pablo-CEU, CEU Universities, Madrid, España.'}]",Allergy,['10.1111/all.14565'] 1230,32768376,Effect of Various Exercises on Intrinsic Capacity in Older Adults With Subjective Cognitive Concerns.,"OBJECTIVES Physical activity is associated with improvement in overall health and well-being, but robust evidence with comprehensive assessment of general health is lacking. This study aimed to clarify the effects of physical activity on intrinsic capacity among community-dwelling older adults with subjective memory concerns. DESIGN A single-blind randomized controlled trial compared aerobic training (AT), resistance training (RT), and combined training (AT+RT) programs for improving general health evaluated by intrinsic capacity. SETTING Toyota, Japan. PARTICIPANTS Residents (65-85 years old) who screened positive for subjective memory concerns using the Kihon checklist were invited for eligibility assessment. In total, 415 community-dwelling older adults were enrolled and randomized into the AT, RT, AT+RT, and control groups. METHODS Participants in the intervention groups underwent a group training program and self-paced home training for 26 weeks. The control group received lectures about health promotion. Intrinsic capacity (IC), constructed based on locomotion, cognition, psychological function, and vitality domains, was used to assess general health at baseline, week 26, and week 52. Between-group differences were exhibited with Z-score change in individual domain and combination of all domains. RESULTS At baseline, mean age of all participants (47% women) was 72.3 ± 4.6 years, with a mean composited IC Z-score of -0.2 ± 0.5. Overall, AT and RT improved composite IC Z-scores by 0.17 (95% confidence interval [CI] 0.03-0.30) and 0.17 (95% CI 0.05-0.28) at week 26, respectively, but the beneficial effects waned at week 52. No significant differences in composite IC Z-scores were found in the AT+RT group at weeks 26 and 52. CONCLUSIONS AND IMPLICATIONS Twenty-six-week AT with self-paced home training and RT with self-paced home training improve IC among community-dwelling older adults with subjective memory concerns, but the benefits waned subsequently. It will be required to develop optimal interventions that have a continuous beneficial effect on IC among community-dwelling older adults.",2021,"Overall, AT and RT improved composite IC Z-scores by 0.17 (95% confidence interval [CI] 0.03-0.30) and 0.17 (95% CI 0.05-0.28) at week 26, respectively, but the beneficial effects waned at week 52.","['Older Adults With Subjective Cognitive Concerns', 'Toyota, Japan', 'community-dwelling older adults with subjective memory concerns', 'community-dwelling older adults', 'Participants in the intervention groups underwent a', '415 community-dwelling older adults', 'Residents (65-85\xa0years old) who screened positive for subjective memory concerns using the Kihon checklist were invited for eligibility assessment']","['lectures about health promotion', 'AT+RT', 'Various Exercises', 'physical activity', 'RT with self-paced home training improve IC', 'aerobic training (AT), resistance training (RT), and combined training (AT+RT) programs', 'group training program and self-paced home training']","['Overall, AT and RT improved composite IC Z-scores', 'Intrinsic capacity (IC), constructed based on locomotion, cognition, psychological function, and vitality domains', 'Intrinsic Capacity', 'composite IC Z-scores', 'intrinsic capacity']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517772', 'cui_str': '415'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023946', 'cui_str': 'Locomotor Activity'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0233398', 'cui_str': 'Psychological function'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",415.0,0.0343818,"Overall, AT and RT improved composite IC Z-scores by 0.17 (95% confidence interval [CI] 0.03-0.30) and 0.17 (95% CI 0.05-0.28) at week 26, respectively, but the beneficial effects waned at week 52.","[{'ForeName': 'Chi Hsien', 'Initials': 'CH', 'LastName': 'Huang', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Aichi Prefecture, Japan; Department of Family Medicine, E-Da Hospital, Kaohsiung City, Taiwan, R.O.C.; School of Medicine for International Students, College of Medicine, I-Shou University, Kaohsiung City, Taiwan, R.O.C.; Institutes of Innovation for Future Society, Nagoya University, Nagoya, Aichi Prefecture, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Umegaki', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Aichi Prefecture, Japan.'}, {'ForeName': 'Taeko', 'Initials': 'T', 'LastName': 'Makino', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Aichi Prefecture, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Uemura', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Aichi Prefecture, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Hayashi', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Aichi Prefecture, Japan.'}, {'ForeName': 'Tomoharu', 'Initials': 'T', 'LastName': 'Kitada', 'Affiliation': 'Institutes of Innovation for Future Society, Nagoya University, Nagoya, Aichi Prefecture, Japan.'}, {'ForeName': 'Aiko', 'Initials': 'A', 'LastName': 'Inoue', 'Affiliation': 'Institutes of Innovation for Future Society, Nagoya University, Nagoya, Aichi Prefecture, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Shimada', 'Affiliation': 'Department of Preventive Gerontology, Center for Gerontology and Social Science, National Center for Geriatrics and Gerontology, Obu City, Aichi Prefecture, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Kuzuya', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Aichi Prefecture, Japan; Institutes of Innovation for Future Society, Nagoya University, Nagoya, Aichi Prefecture, Japan. Electronic address: kuzuya@med.nagoya-u.ac.jp.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2020.06.048'] 1231,32770693,"Single-Plane Versus Dual-Plane Microfocused Ultrasound With Visualization in the Treatment of Upper Arm Skin Laxity: A Randomized, Single-Blinded, Controlled Trial.","BACKGROUND AND OBJECTIVES Non-invasive skin tightening devices have become a safe and non-invasive treatment for patients with skin laxity of the upper arm. The efficacy of microfocused ultrasound with visualization (MFU-V) in skin tightening had been demonstrated in several studies. This study aimed to evaluate the efficacy and safety of MFU-V in treating skin laxity of the upper arm using different treatment protocols. STUDY DESIGN/MATERIALS AND METHODS Thirty patients with upper arm laxity were enrolled. Patients were randomly assigned to receive single-plane MFU-V treatment (4 MHz/4.5 mm transducer) on one arm and dual-plane treatment (4 MHz/4.5 mm and 7 MHz/3.0 mm transducer) on the contralateral arm, totaling 200 lines in each arm. Investigator Assessment Skin Laxity Scoring System (IASLSS) and improvement scores were evaluated at 1, 3, and 6 months after the treatment. Adverse events were recorded. RESULTS A modest reduction of mean arm circumference was observed on both sides. Mean physician-rated improvement scores,  single-plane treatment received 2.22 (±1.05), 2.70 (±1.32), and 1.61 (±0.79), respectively. Dual-plane treatment received 2.00 (±1.00), 2.56 (±1.05), and 1.39 (±0.54), respectively. Single-plane treatment was superior from physician's ratings (P < 0.05). IASLSS followed the same trend as the improvement scores. Mean patient-rated improvement scores in single-plane treatment were 3.63 (±2.63), 3.69 (±2.83), 1.90(±2.51) for 1, 3, and 6 months, respectively. Dual-plane treatment received 3.5 (±2.57), 3.22 (±2.59), 1.78 (±2.48), respectively. The median pain scores were 2.6 (0-8) for single-plane treatment and 1.9 (0-8) for dual-plane treatment (P = 0.136). No other significant side effects were observed. CONCLUSION Both single-plane and dual-plane treatment provide a modest skin tightening effect in the upper arm for at least 3 months. Physicians should assess skin thickness in every patient using the visualization screen to select the appropriate transducer for each individual patient. Lasers Surg. Med. © 2020 Wiley Periodicals LLC.",2021,Single-plane treatment was superior from physician's ratings (P < 0.05).,"['Upper Arm Skin Laxity', 'Thirty patients with upper arm laxity were enrolled', 'patients with skin laxity of the upper arm']","['Single-Plane Versus Dual-Plane Microfocused Ultrasound With Visualization', 'single-plane MFU-V treatment (4\u2009MHz/4.5\u2009mm transducer) on one arm and dual-plane treatment', 'microfocused ultrasound with visualization (MFU-V', 'MFU-V']","['Mean physician-rated improvement scores', 'skin thickness', 'Mean patient-rated improvement scores', 'median pain scores', 'Adverse events', 'Investigator Assessment Skin Laxity Scoring System (IASLSS) and improvement scores', 'skin tightening effect', 'mean arm circumference', 'side effects']","[{'cui': 'C0230348', 'cui_str': 'Both upper arms'}, {'cui': 'C0010495', 'cui_str': 'Cutis laxa'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332536', 'cui_str': 'Laxity'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040661', 'cui_str': 'Transducer'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0423756', 'cui_str': 'Thickness of skin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0558035', 'cui_str': 'Skin assessment'}, {'cui': 'C0332536', 'cui_str': 'Laxity'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",30.0,0.0247437,Single-plane treatment was superior from physician's ratings (P < 0.05).,"[{'ForeName': 'Vasanop', 'Initials': 'V', 'LastName': 'Vachiramon', 'Affiliation': 'Division of Dermatology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Korn', 'Initials': 'K', 'LastName': 'Triyangkulsri', 'Affiliation': 'Division of Dermatology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Wimolsiri', 'Initials': 'W', 'LastName': 'Iamsumang', 'Affiliation': 'Division of Dermatology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Chayavichitsilp', 'Affiliation': 'Division of Dermatology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.'}]",Lasers in surgery and medicine,['10.1002/lsm.23307'] 1232,32779626,Corrigendum*: Effects of Computer-based Stress Management Training on Psychological Well-being and Work Performance in Japanese Employees: A Cluster Randomized Controlled Trial.,"In Table 2, Mean and SD were opposite between the intervention group and the wait-list control group. In Table 3, there was a mistake in the annotation: the number of the intervention group was 142. The corrected Table 2 and Table 3 are presented below. We apologize for any inconvenience that this may have caused. *Important errors made by the author(s).",2020,"In Table 2, Mean and SD were opposite between the intervention group and the wait-list control group.",['Japanese Employees'],['Computer-based Stress Management Training'],['Psychological Well-being and Work Performance'],"[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0599987', 'cui_str': 'Employee'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C1286385', 'cui_str': 'Performance at work'}]",,0.0325394,"In Table 2, Mean and SD were opposite between the intervention group and the wait-list control group.","[{'ForeName': 'Rino', 'Initials': 'R', 'LastName': 'Umanodan', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Japan.'}, {'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Shimazu', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Japan.'}, {'ForeName': 'Masahide', 'Initials': 'M', 'LastName': 'Minami', 'Affiliation': 'Department of Public Health / Health Policy, The University of Tokyo, Japan.'}, {'ForeName': 'Norito', 'Initials': 'N', 'LastName': 'Kawakam', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Japan.'}]",Industrial health,['10.2486/indhealth.2013-0209c1'] 1233,32779711,The Impact of Moderate or High-Intensity Combined Exercise on Systemic Inflammation Among Older Persons With and Without HIV.,"BACKGROUND We investigated whether higher-intensity exercise provided greater decrease in markers of inflammation, and whether responses differed by HIV serostatus. METHODS People with HIV (PWH; n = 32) and controls (n = 37) aged 50-75 years completed 12 weeks moderate-intensity exercise, then were randomized to moderate- or high-intensity exercise for 12 additional weeks (n = 27 and 29, respectively). Inflammation biomarkers were measured at 0, 12, 24 weeks. Mixed and multiple regression models were adjusted for baseline inflammation, age, and body mass index. RESULTS Baseline tumor necrosis factor-α (TNF-α), soluble TNF receptor 2 (sTNFR2), and soluble CD14 (sCD14) were significantly higher among PWH than controls (P < .04). From week 0-12, changes in interleukin-6 (IL-6), TNF-α, and sTNFR1 were not significantly different by HIV serostatus. We found no significant interaction between HIV serostatus/exercise intensity on week 12-24 changes in IL-6, TNF-α, and sTNFR1. Among high-intensity exercisers, PWH and controls had significant increases in sCD14 (P ≤ .003), controls significant increases in IL-10 (P = .01), and PWH nonsignificant decrease in highly sensitive C-reactive protein (P = .07). Other markers were not significantly different by serostatus or intensity. CONCLUSIONS Moderate and high-intensity exercise elicited similar effects on inflammation among PWH and controls, with additional beneficial effects seen among high-intensity exercisers. Increase in sCD14 and attenuated IL-10 increase (PWH only) merit further study. CLINICAL TRIALS REGISTRATION NCT02404792.",2021,"We found no significant interaction between HIV serostatus/exercise intensity on week 12-24 changes in IL-6, TNF-α, sTNFR1.","['People with HIV (PWH; n=32) and controls (n=37) aged 50-75 completed 12 weeks of', 'Older Persons with and without HIV']","['moderate- or high-intensity exercise', 'Moderate or High-Intensity Combined Exercise', 'moderate-intensity combined exercise']","['hsCRP', 'Inflammation biomarkers', 'sCD14', 'Baseline TNF-α, sTNFR2, and sCD14', 'Systemic Inflammation', 'IL-6, TNF-α, sTNFR1', 'IL-10']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]",,0.129495,"We found no significant interaction between HIV serostatus/exercise intensity on week 12-24 changes in IL-6, TNF-α, sTNFR1.","[{'ForeName': 'Kristine M', 'Initials': 'KM', 'LastName': 'Erlandson', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Melissa P', 'Initials': 'MP', 'LastName': 'Wilson', 'Affiliation': 'School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'MaWhinney', 'Affiliation': 'School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Rapaport', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Cara C', 'Initials': 'CC', 'LastName': 'Wilson', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Jeremy T', 'Initials': 'JT', 'LastName': 'Rahkola', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Edward N', 'Initials': 'EN', 'LastName': 'Janoff', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Todd T', 'Initials': 'TT', 'LastName': 'Brown', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Diabetes, and Metabolism, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Campbell', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Jankowski', 'Affiliation': 'College of Nursing, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa494'] 1234,32776202,Tiotropium/Olodaterol Decreases Exacerbation Rates Compared with Tiotropium in a Range of Patients with COPD: Pooled Analysis of the TONADO ® /DYNAGITO ® Trials.,"INTRODUCTION Previous studies demonstrated that tiotropium/olodaterol reduced rates of exacerbations in patients with chronic obstructive pulmonary disease (COPD). However, this should be examined in a wider population. METHODS This post hoc analysis pooled data from TONADO ® 1 + 2 and DYNAGITO ® , three 52-week, parallel-group, randomised, double-blind, phase III trials investigating patients with moderate-to-very severe COPD, with and without previous exacerbations, who received tiotropium/olodaterol 5/5 µg or tiotropium 5 µg. Subgroup analyses were conducted on patients stratified by exacerbation history, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 2-4 disease severity and baseline inhaled corticosteroid (ICS) use. RESULTS In 9942 patients, tiotropium/olodaterol was associated with lower rates of moderate/severe exacerbations (0.68 vs. 0.77 per patient-year; rate ratio (RR) vs. tiotropium 0.89, 95% confidence interval (CI) 0.84, 0.95; P = 0.0003) and exacerbations requiring hospitalisation (0.11 vs. 0.13 per patient-year; RR 0.86, 95% CI 0.75, 0.99; P = 0.0380) versus tiotropium. Lower rates of moderate/severe exacerbations with tiotropium/olodaterol versus tiotropium were evident in patients with 0-1 moderate exacerbation in the previous year (0.54 vs. 0.60 per patient-year; RR 0.90, 95% CI 0.82, 0.98; P = 0.0187) and at least two moderate or at least one severe exacerbation(s) in the previous year (0.97 vs. 1.09 per patient-year; RR 0.89, 95% CI 0.82, 0.97; P = 0.0096). In patients with GOLD 2 and GOLD 3 COPD, moderate/severe exacerbation rates were lower with tiotropium/olodaterol versus tiotropium; GOLD 4 patients showed negligible difference between treatments. When evaluating patients by baseline ICS use, there was a significantly lower rate of moderate/severe exacerbations with tiotropium/olodaterol versus tiotropium in patients receiving ICS. CONCLUSIONS Tiotropium/olodaterol decreased the rate of moderate/severe exacerbations and exacerbations leading to hospitalisation versus tiotropium. Results from this large, pooled, post hoc analysis support the use of dual bronchodilation with tiotropium/olodaterol in a broad range of patients, reflective of patients with COPD in clinical practice. TRIAL REGISTRATION TONADO ®  1 (ClinicalTrials.gov: NCT01431274); TONADO ®  2 (ClinicalTrials.gov: NCT01431287); DYNAGITO ® (ClinicalTrials.gov: NCT02296138). People with chronic obstructive pulmonary disease (COPD) may have times when their symptoms worsen, known as exacerbations. This may mean that they need to take additional medications, such as antibiotics or oral steroids. Studies have shown that a combination of two types of inhaled medicine-tiotropium and olodaterol-can help to reduce exacerbations in some people. To see if this is also the case across a larger and more diverse range of people, we combined the results from three studies (TONADO ®  1 + 2 and DYNAGITO ® ) that looked at people who were taking tiotropium and olodaterol together and people who were taking tiotropium alone. We showed that, across a wide range of people, treatment with tiotropium/olodaterol was generally better at reducing exacerbations than tiotropium. Tiotropium/olodaterol also decreased the number of exacerbations that led to hospitalisation compared with tiotropium. Overall, our results support the use of combined tiotropium/olodaterol in people at different stages of COPD.",2020,"In 9942 patients, tiotropium/olodaterol was associated with lower rates of moderate/severe exacerbations (0.68 vs. 0.77 per patient-year; rate ratio (RR) vs. tiotropium 0.89, 95% confidence interval (CI) 0.84, 0.95; P = 0.0003) and exacerbations requiring hospitalisation (0.11 vs. 0.13 per patient-year; RR 0.86, 95% CI 0.75, 0.99; P = 0.0380) versus tiotropium.","['patients with moderate-to-very severe COPD, with and without previous exacerbations, who received', 'patients stratified by exacerbation history, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 2-4 disease severity and baseline inhaled corticosteroid (ICS) use', 'patients with chronic obstructive pulmonary disease (COPD', 'Patients with COPD', 'People with chronic obstructive pulmonary disease (COPD']","['tiotropium/olodaterol versus tiotropium; GOLD', 'tiotropium/olodaterol 5/5\xa0µg or tiotropium 5\xa0µg', 'Tiotropium/Olodaterol', 'tiotropium/olodaterol', 'Tiotropium/olodaterol', 'inhaled medicine-tiotropium', 'tiotropium/olodaterol versus tiotropium', 'Tiotropium', 'tiotropium']","['number of exacerbations', 'severe exacerbation rates', 'rate of moderate/severe exacerbations', 'Lower rates of moderate/severe exacerbations', 'Exacerbation Rates', 'exacerbations requiring hospitalisation', 'rates of moderate/severe exacerbations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C2934193', 'cui_str': 'olodaterol'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",9942.0,0.709479,"In 9942 patients, tiotropium/olodaterol was associated with lower rates of moderate/severe exacerbations (0.68 vs. 0.77 per patient-year; rate ratio (RR) vs. tiotropium 0.89, 95% confidence interval (CI) 0.84, 0.95; P = 0.0003) and exacerbations requiring hospitalisation (0.11 vs. 0.13 per patient-year; RR 0.86, 95% CI 0.75, 0.99; P = 0.0380) versus tiotropium.","[{'ForeName': 'Jadwiga A', 'Initials': 'JA', 'LastName': 'Wedzicha', 'Affiliation': 'Respiratory Division, National Heart and Lung Institute, Imperial College London, London, UK. j.wedzicha@imperial.ac.uk.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Buhl', 'Affiliation': 'Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Claus F', 'Initials': 'CF', 'LastName': 'Vogelmeier', 'Affiliation': 'Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps University of Marburg, Member of the German Center for Lung Research (DZL), Marburg, Germany.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'de la Hoz', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Wenqiong', 'Initials': 'W', 'LastName': 'Xue', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Anzueto', 'Affiliation': 'Department of Pulmonary Medicine and Critical Care, University of Texas Health Sciences Center and South Texas Veterans Health Care System, San Antonio, TX, USA.'}, {'ForeName': 'Peter M A', 'Initials': 'PMA', 'LastName': 'Calverley', 'Affiliation': 'Clinical Science Centre, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}]",Advances in therapy,['10.1007/s12325-020-01438-3'] 1235,32782361,RCT of group versus individual PFMT.,,2020,,[],['RCT of group versus individual PFMT'],[],[],"[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],,0.0180887,,"[{'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Fenner', 'Affiliation': 'Nature Reviews Urology, . nruro@nature.com.'}]",Nature reviews. Urology,['10.1038/s41585-020-0367-z'] 1236,32780605,"Does Bilevel Noninvasive Ventilation Have a Bronchodilating Effect and Alter Respiratory Mechanics in Asthmatic Individuals After Bronchoprovocation? Randomized, Crossover Study.","Background: Noninvasive ventilation (NIV) has an additional important effect that does not occur with medicinal therapy: a reduction in the work of breathing. Understanding the mechanical effects of these therapies is of considerable importance and can affect clinical decision making. Objective: Evaluate the effects of NIV compared to albuterol on lung function and respiratory mechanics in asthmatic adolescents and young adults after bronchoprovocation and determine the effects of a hypertonic saline solution on lung function respiratory mechanics. Methods: A randomized crossover study was conducted involving individuals with a diagnosis of asthma. Evaluations were performed with optoelectronic plethysmography (OEP) and spirometry at baseline, after the bronchial provocation test with 4.5% saline solution and after the intervention. The order of the procedures (bilevel NIV and albuterol) was randomized, with the participants crossing over to the other treatment after a 1-week washout period. Inspiratory positive airway pressure (IPAP) 12 and expiratory positive airway pressure (EPAP) 8 cmH 2 O were set for 10 minutes and the dose of albuterol was 400 μg. Results: Forty individuals were included in the study (mean age: 21.6 ± 4 years; 24 females). The recovery of FEV 1 % was 87.9% (80.8 ± 35 to 101.1 ± 46.1, p  < 0.05) after NIV and 95.9% (84.4 ± 42.4 to 110.3 ± 44.3, p  < 0.05) after albuterol. Inspiratory capacity (IC; L) reduced 12% to 15% after bronchoprovocation, with 100% recovery using NIV (2.1 ± 0.7 to 2.42.4 ± 0.6, p  < 0.05) and 107.6% using albuterol (2.2 ± 0.8 to 2.8 ± 1.1, p  < 0.05). Regarding OEP variables, tidal volume had greater participation in the thoracic compartment. NIV led to an increase in minute volume and a return to the baseline value, which did not occur with albuterol. Conclusion: NIV recovered FEV 1 and improves signs of hyperinflation by improving IC. Bronchoprovocation with a hypertonic solution reduced FEV 1 by 20% and reduced IC. NIV led to a faster recovery of minute volume and reduced the contraction velocity of the muscles of the rib cage compared to albuterol, although the effects on lung function were less intense.",2021,"NIV led to a faster recovery of minute volume and reduced the contraction velocity of the muscles of the rib cage compared to albuterol, although the effects on lung function were less intense.","['individuals with a diagnosis of asthma', 'asthmatic adolescents and young adults after bronchoprovocation', 'Asthmatic Individuals', 'Forty individuals were included in the study (mean age: 21.6\u2009±\u20094 years; 24 females']","['hypertonic saline solution', 'hypertonic solution', ': Noninvasive ventilation (NIV', 'albuterol', 'NIV']","['contraction velocity', 'signs of hyperinflation by improving IC', 'Inspiratory positive airway pressure (IPAP) 12 and expiratory positive airway pressure (EPAP) 8 cmH', 'Inspiratory capacity (IC; L', 'lung function and respiratory mechanics', 'recovery of FEV', 'lung function', 'optoelectronic plethysmography (OEP) and spirometry', 'minute volume']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0020554', 'cui_str': 'Hypertonic solutions'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0751673', 'cui_str': 'Nipah virus'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}]","[{'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0020449', 'cui_str': 'Hyperdistention'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C3697361', 'cui_str': 'Expiratory positive airway pressure'}, {'cui': 'C0949658', 'cui_str': 'Primary familial hypertrophic cardiomyopathy'}, {'cui': 'C0021610', 'cui_str': 'Inspiratory capacity'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0032221', 'cui_str': 'Plethysmography'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0428679', 'cui_str': 'Minute volume'}]",40.0,0.088193,"NIV led to a faster recovery of minute volume and reduced the contraction velocity of the muscles of the rib cage compared to albuterol, although the effects on lung function were less intense.","[{'ForeName': 'Evelim Leal de Freitas Dantas', 'Initials': 'ELFD', 'LastName': 'Gomes', 'Affiliation': 'Rehabilitation Sciences Program, Universidade Nove de Julho (UNINOVE), São Paulo, Brazil.'}, {'ForeName': 'Carla Lima Feitosa', 'Initials': 'CLF', 'LastName': 'Cavassini', 'Affiliation': 'Rehabilitation Sciences Program, Universidade Nove de Julho (UNINOVE), São Paulo, Brazil.'}, {'ForeName': 'Maisi Cabral Muniz', 'Initials': 'MCM', 'LastName': 'David', 'Affiliation': 'Rehabilitation Sciences Program, Universidade Nove de Julho (UNINOVE), São Paulo, Brazil.'}, {'ForeName': 'Josiane Germano', 'Initials': 'JG', 'LastName': 'Luiz', 'Affiliation': 'Rehabilitation Sciences Program, Universidade Nove de Julho (UNINOVE), São Paulo, Brazil.'}, {'ForeName': 'Adriana do Carmo', 'Initials': 'ADC', 'LastName': 'Santos', 'Affiliation': 'Rehabilitation Sciences Program, Universidade Nove de Julho (UNINOVE), São Paulo, Brazil.'}, {'ForeName': 'Aldenice Magalhães', 'Initials': 'AM', 'LastName': 'Capeletti', 'Affiliation': 'Rehabilitation Sciences Program, Universidade Nove de Julho (UNINOVE), São Paulo, Brazil.'}, {'ForeName': 'Dirceu', 'Initials': 'D', 'LastName': 'Costa', 'Affiliation': 'Rehabilitation Sciences Program, Universidade Nove de Julho (UNINOVE), São Paulo, Brazil.'}]",Journal of aerosol medicine and pulmonary drug delivery,['10.1089/jamp.2020.1608'] 1237,32801102,"Associations between seizure severity change and patient characteristics, changes in seizure frequency, and health-related quality of life in patients with focal seizures treated with adjunctive eslicarbazepine acetate: Post hoc analyses of clinical trial results.","The relationships between seizure severity change and patient characteristics, changes in seizure frequency, and health-related quality of life (HRQoL) may be important for determining the overall impact of medication therapy on patients with epilepsy. The objectives of these post hoc analyses of the global Phase III 093-0304 trial (NCT00988429, Study 304) of adjunctive eslicarbazepine acetate (ESL) in patients with refractory focal (partial-onset) seizures (FS) were to evaluate associations between seizure severity change, measured by the Seizure Severity Questionnaire (SSQ), and 1) patient characteristics, 2) seizure frequency change, standardized as the seizure frequency (SSF) per 28-day period, and 3) change in HRQoL, evaluated by the Quality of Life in Epilepsy Inventory-31 (QOLIE-31) and the Montgomery-Åsberg Depression Rating Scale (MADRS). The analyses were conducted on the per-protocol population (PPP) of patients who were randomized to a placebo arm (n = 188) or an ESL-active group that included treatment with adjunctive ESL 800 mg once daily (QD; n = 184) or adjunctive ESL 1200 mg QD (n = 175). General linear models (GLM) were used to measure the association between SSQ change and patient baseline characteristics or percentage change in the SSF from baseline. Associations between changes in the SSQ and changes in the QOLIE-31 and MADRS were examined using GLM with patient baseline characteristics as covariates. Subgroup analyses were performed for patients in the ESL-active group and those treated with ESL 800 mg or ESL 1200 mg. Minimal clinically important difference (MCIDs) thresholds were used to assess improvements in SSQ scores. The analyses included 547 per-protocol patients. Patients using 1 antiepileptic drug (AED) at baseline had greater improvements in the SSQ compared with those receiving 2 AEDs (P = 0.0606). Treatment with ESL 1200 mg was significantly associated with clinically meaningful improvements in the SSQ (P = 0.0005). The SSQ improvements were significantly associated with an SSF reduction of ≥75%, compared with no reduction (P < 0.0001). In the PPP and the ESL-active group, SSQ improvements were significantly associated with improvements in QOLIE-31 Total Score (TS; P < 0.0001) and the Seizure Worry (SW; P < 0.0001) and Social Functioning (SF; P = 0.0030) subscales. In the ESL 1200 mg subgroup, SSQ improvements were significantly associated with improvements in QOLIE-31 TS (P < 0.0001) and the SW (P < 0.0001) and Energy/Fatigue (EF; P = 0.0007) subscales. In the ESL 800 mg subgroup, improvements in the SSQ were significantly associated with improvements in QOLIE-31 TS (P = 0.0362) and the SW (P = 0.0241) subscale. There was no significant association between changes in the SSQ and changes in the MADRS in patients treated with ESL. These findings demonstrated that in this clinical trial population, adding ESL to baseline AED therapy had utility for decreasing seizure severity and improving HRQoL. There were no significant associations between changes in seizure severity and changes in depressive symptoms in patients with FS.",2020,There was no significant association between changes in the SSQ and changes in the MADRS in patients treated with ESL.,"['patients with refractory focal (partial-onset) seizures (FS', 'patients with epilepsy', 'patients with focal seizures treated with']","['adjunctive eslicarbazepine acetate', 'adjunctive eslicarbazepine acetate (ESL', 'adjunctive ESL 1200\u202fmg QD', 'ESL-active group that included treatment with adjunctive ESL 800', 'ESL 800\u202fmg or ESL', 'ESL', 'placebo']","['SSF reduction', 'SSQ scores', 'seizure frequency, and health-related quality of life (HRQoL', 'seizure frequency, and health-related quality of life', 'SSQ', 'QOLIE-31 Total Score', 'Seizure Worry', 'QOLIE-31 and MADRS', 'QOLIE-31 TS', 'seizure severity and improving HRQoL', 'Seizure Severity Questionnaire (SSQ), and 1) patient characteristics, 2) seizure frequency change, standardized as the seizure frequency (SSF) per 28-day period, and 3) change in HRQoL, evaluated by the Quality of Life in Epilepsy Inventory-31 (QOLIE-31) and the Montgomery-Åsberg Depression Rating Scale (MADRS', 'Social Functioning', 'seizure severity and changes in depressive symptoms', 'Energy/Fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C2725262', 'cui_str': 'Eslicarbazepine acetate'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.147528,There was no significant association between changes in the SSQ and changes in the MADRS in patients treated with ESL.,"[{'ForeName': 'Joyce A', 'Initials': 'JA', 'LastName': 'Cramer', 'Affiliation': 'Yale University School of Medicine and Consultant, Houston, TX 77027, United States of America. Electronic address: joyce.cramer@gmail.com.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Colman', 'Affiliation': 'Covance Inc., Suite 3.02, Level 3, Building A, 97 Waterloo Road, Macquarie Corporate Centre, Macquarie Park, New South Wales 2113, Australia. Electronic address: Sam.Colman@covance.com.'}, {'ForeName': 'Kathryn P', 'Initials': 'KP', 'LastName': 'Anastassopoulos', 'Affiliation': 'Covance Inc., 9801 Washingtonian Blvd., 9th. Floor, Gaithersburg, MD 20878, United States of America. Electronic address: kathryn.anastassopoulos@covance.com.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Grinnell', 'Affiliation': 'Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA 01752, United States of America. Electronic address: Todd.Grinnell@sunovion.com.'}, {'ForeName': 'Darshan', 'Initials': 'D', 'LastName': 'Mehta', 'Affiliation': 'Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA 01752, United States of America. Electronic address: Darshan.Mehta@sunovion.com.'}, {'ForeName': 'G Rhys', 'Initials': 'GR', 'LastName': 'Williams', 'Affiliation': 'Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA 01752, United States of America. Electronic address: Gwilym.Williams@sunovion.com.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107312'] 1238,32818946,Greater Attendance at a Community Weight Loss Programme over the First 12 Weeks Predicts Weight Loss at 2 Years.,"BACKGROUND There is considerable heterogeneity in long-term weight loss among people referred to obesity treatment programmes. It is unclear whether attendance at face-to-face sessions in the early weeks of the programme is an independent predictor of long-term success. OBJECTIVE To investigate whether frequency of attendance at a community weight loss programme over the first 12 weeks is associated with long-term weight change. METHODS Participants were randomised to receive brief support only (control, n = 211), or a weight loss programme for 12 weeks (n = 530) or 52 weeks (n = 528). This study included participants with data on session attendance over the first 12 weeks (n = 889) compared to the control group. The association between attendance (continuously) and weight loss was explored using a linear model. A multi-level mixed-effects linear model was used to investigate whether attendance (categorised as 0, 1, 2-5, 6-9, and 10-12 sessions) was associated with weight loss at 3, 12, and 24 months compared to the control. RESULTS For every session attended in the first 12 weeks, the average weight loss was -0.259 kg/session at 24 months (p = 0.005). Analysis by attendance group found only those attending 10-12 sessions had significantly greater weight loss (-7.5 kg [95% CI -8.1 to -6.9] at 12 months; -4.7 kg [95% CI -5.3 to -4.1] at 24 months) compared to the control group (-3.4 [95% CI -4.5 to -2.4] at 12 months, -2.5 [95% CI -3.5 to -1.5] at 24 months). Early attendance was higher for people ≥70 years, but there was no evidence of a difference by gender, ethnicity, education, or income. CONCLUSIONS Greater attendance at a community weight loss programme in the first 12 weeks is associated with enhanced weight loss up to 24 months. Regular attendance at a programme could be used as a criterion for continued provision of weight loss services to maximise the cost-effectiveness of interventions.",2020,"Early attendance was higher for people ≥70 years, but there was no evidence of a difference by gender, ethnicity, education, or income. ","['Participants', 'participants with data on session attendance over the first 12 weeks (n = 889', 'people referred to obesity treatment programmes']",['weight loss programme'],"['weight loss', 'enhanced weight loss', 'attendance (continuously) and weight loss', 'average weight loss']","[{'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]",,0.0377466,"Early attendance was higher for people ≥70 years, but there was no evidence of a difference by gender, ethnicity, education, or income. ","[{'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Piernas', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom, carmen.piernas-sanchez@phc.ox.ac.uk.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'MacLean', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Ahern', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Woolston', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Boyland', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Jason C G', 'Initials': 'JCG', 'LastName': 'Halford', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}]",Obesity facts,['10.1159/000509131'] 1239,32820861,Biosimilarity Assessment of 2 Filgrastim Therapeutics in Healthy Volunteers.,"This study aimed to compare the pharmacokinetic, pharmacodynamic, and safety profiles of a proposed biosimilar and innovator filgrastim therapeutics in healthy volunteers. In a crossover design, 23 subjects received a single subcutaneous injection of 300-µg filgrastim, followed by a 7-day washout period. Assessed pharmacokinetic parameters were the maximum observed filgrastim serum concentration (C max ), time to reach C max (t max ), the area under the concentration-time curve (AUC), and elimination half-life. Pharmacodynamics were assessed by the maximum observed absolute neutrophil count effect (E max ), t max,E (time to reach E max ), and the area under the effect of the absolute neutrophil count -time curve. The test/reference ratio (90% confidence intervals) of C max of 0.992 (0.860-1.143), AUC 0-inf of 0.995 (0.891-1.111), E max of 0.952 (0.841, 1.078), and area under the effect of the absolute neutrophil count -time curve from time zero to 96 hours of 0.939 (0.854-1.032), were all well within the predefined equivalence boundaries of 80% and 125%. Obtained values for t max (∼4 hours), t max,E (∼15 hours), and elimination half-life (∼3.5 hours) were comparable between 2 treatment groups. The local tolerability and incidence of adverse events were comparable, with no clinically meaningful difference between biosimilar and innovator products. Altogether, the results suggested a high similarity of the proposed biosimilar to the innovator filgrastim in healthy volunteers.",2021,"The local tolerability and incidence of adverse events were comparable, with no clinically meaningful difference between biosimilar and innovator products.","['Healthy Volunteers', 'healthy volunteers', '23 subjects received a']",['single subcutaneous injection of 300-µg filgrastim'],"['absolute neutrophil count -time curve', 'absolute neutrophil count effect (E max ), t max,E (time to reach E max ), and the area under the effect of the absolute neutrophil count -time curve', 'filgrastim serum concentration (C max ), time to reach C max (t max ), the area under the concentration-time curve (AUC), and elimination half-life', 'local tolerability and incidence of adverse events', 'pharmacokinetic, pharmacodynamic, and safety profiles']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0210630', 'cui_str': 'Filgrastim'}]","[{'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.023003,"The local tolerability and incidence of adverse events were comparable, with no clinically meaningful difference between biosimilar and innovator products.","[{'ForeName': 'Seyed Reza', 'Initials': 'SR', 'LastName': 'Khandoozi', 'Affiliation': 'Department of Oncology, 5 Azar Hospital, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Shahbazi', 'Affiliation': 'Medical Cellular and Molecular Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Amini', 'Affiliation': 'Medical Cellular and Molecular Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.856'] 1240,32821924,Association of Sex or Race With the Effect of Weight Loss on Physical Function: A Secondary Analysis of 8 Randomized Clinical Trials.,"Importance Consideration of differential treatment effects among subgroups in clinical trial research is a topic of increasing interest. This is an especially salient issue for weight loss trials. Objective To determine whether stratification by sex and race is associated with meaningful differences in physical function response to weight loss among older adults. Design, Setting, and Participants This pooled analysis used individual-level data from 8 completed randomized clinical trials of weight loss conducted at Wake Forest University or Wake Forest School of Medicine, Winston-Salem, North Carolina. Data were housed within the Wake Forest Older Americans Independence Center data repository and provided complete exposure, outcome, and covariate information. Data were collected from November 1996 to March 30, 2017, and analyzed from August 15, 2019, to June 10, 2020. Exposures Treatment arms within each study were collapsed into caloric restriction (CR [n = 734]) and non-CR (n = 583) categories based on whether caloric restriction was specified in the original study protocol. Main Outcomes and Measures Objectively measured 6-month change in weight, fast-paced gait speed (meters per second), and Short Physical Performance Battery (SPPB) score. Results A total of 1317 adults (mean [SD] age, 67.7 [5.4] years; 920 [69.9%] female; 275 [20.9%] Black) with overweight or obesity (mean [SD] body mass index [calculated as weight in kilograms divided by height in meters squared], 33.9 [4.4]) were included at baseline. Six-month weight change achieved among those randomized to CR was -7.7% (95% CI, -8.3% to -7.2%), with no difference noted by sex; however, White individuals lost more weight than Black individuals assigned to CR (-9.0% [95% CI, -9.6% to -8.4%] vs -6.0% [95% CI, -6.9% to 5.2%]; P < .001), and all CR groups lost a significantly greater amount from baseline compared with non-CR groups (Black participants in CR vs non-CR groups, -5.3% [95% CI, -6.4% to -4.1%; P < .001]; White participants in CR vs non-CR groups, -7.2% [95% CI, -7.8% to -6.6%; P < .001]). Women experienced greater weight loss-associated improvement in SPPB score (CR group, 0.35 [95% CI, 0.18-0.52]; non-CR group, 0.08 [95% CI, -0.11 to 0.27]) compared with men (CR group, 0.23 [95% CI, 0.00-0.46]; non-CR group, 0.34 [95% CI, 0.09-0.58]; P = .03). Black participants experienced greater weight loss-associated improvement in gait speed (CR group, 0.08 [95% CI, 0.05-0.10] m/s; non-CR group, 0.02 [95% CI, -0.01 to 0.05] m/s) compared with White participants (CR group, 0.07 [95% CI, 0.06-0.09] m/s; non-CR group, 0.06 [95% CI, 0.04-0.08] m/s; P = .02). Conclusions and Relevance The association of weight loss on physical function in older adults appears to differ by sex and race. These findings affirm the need to consider biological variables in clinical trial design.",2020,"Black participants experienced greater weight loss-associated improvement in gait speed (CR group, 0.08 [95% CI, 0.05-0.10] m/s;","['older adults', 'weight loss conducted at Wake Forest University or Wake Forest School of Medicine, Winston-Salem, North Carolina', 'A total of 1317 adults (mean [SD] age, 67.7\u2009[5.4] years; 920', '69.9%] female; 275 [20.9%] Black) with overweight or obesity (mean [SD] body mass index [calculated as weight in kilograms divided by height in meters squared], 33.9\u2009[4.4]) were included at baseline', 'Data were collected from November 1996 to March 30, 2017, and analyzed from August 15, 2019, to June 10, 2020']",[],"['Main Outcomes and Measures\n\n\nObjectively measured 6-month change in weight, fast-paced gait speed (meters per second), and Short Physical Performance Battery (SPPB) score', 'SPPB score', 'weight loss', 'Physical Function', 'weight loss-associated improvement in gait speed']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0086312', 'cui_str': 'Forest'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C4517718', 'cui_str': '33.9'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]",[],"[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0439493', 'cui_str': 'm/s'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4075289', 'cui_str': 'Short Physical Performance Battery score'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]",1317.0,0.165494,"Black participants experienced greater weight loss-associated improvement in gait speed (CR group, 0.08 [95% CI, 0.05-0.10] m/s;","[{'ForeName': 'Kristen M', 'Initials': 'KM', 'LastName': 'Beavers', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'Rebecca H', 'Initials': 'RH', 'LastName': 'Neiberg', 'Affiliation': 'Department of Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Kritchevsky', 'Affiliation': 'Sections of Gerontology and Cardiovascular Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Nicklas', 'Affiliation': 'Sections of Gerontology and Cardiovascular Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Dalane W', 'Initials': 'DW', 'LastName': 'Kitzman', 'Affiliation': 'Sections of Gerontology and Cardiovascular Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Messier', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'W Jack', 'Initials': 'WJ', 'LastName': 'Rejeski', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'Jamy D', 'Initials': 'JD', 'LastName': 'Ard', 'Affiliation': 'Department of Epidemiology and Prevention, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Beavers', 'Affiliation': 'Department of Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.14631'] 1241,32822218,Promote or inhibit: An inverted U-shaped effect of workload on driver takeover performance.,"OBJECTIVE In conditional automated driving (SAE Level 3), drivers are required to take over their vehicles when the automated systems fail. Non-driving related tasks (NDRTs) can positively or negatively affect takeover safety, but the underlying reasons for this inconsistency remain unclear. This study aims to investigate how various workload levels generated by NDRTs may influence the takeover performance of drivers and the lead time they require. METHOD Fifty drivers were randomly distributed into five groups, which corresponded to five workload levels (1-4 levels generated by Tetris game; control level generated by monitoring). Each driver completed vehicle takeover tasks upon receiving takeover requests with various lead times (3, 5, 7, 9, and 11 s) while engaging in NDRTs. The drivers' takeover performance and subjective opinions were recorded. RESULTS Drivers in the moderate workload condition (i.e., level 3) had significantly shorter takeover times and better takeover quality than those in the lower (i.e., level 1 and level 2) or higher (i.e., level 4) workload conditions. They also subjectively required less lead time in the moderate condition. Moreover, the drivers rated 7 s as the most appropriate lead time despite the improvement in their overall takeover performances with increased lead time. CONCLUSIONS This study found an inverted U-shaped relationship between the drivers' workload generated by NDRTs and takeover performance. The moderate workload level (rather than the lower or higher workload level) led to a faster and better takeover performance, and it seemed to require minimal lead time for drivers. These findings help understand the relationship of drivers' workload during the automation and takeover performance in conditional automated driving. An important recommendation emerging from this work is to investigate what should be the most efficient method to detect the drivers' workload state real-time and give feedback to them when it comes to overload or underload during the automated driving.",2020,"The moderate workload level (rather than the lower or higher workload level) led to a faster and better takeover performance, and it seemed to require minimal lead time for drivers.",['Fifty drivers'],[],"['shorter takeover times and better takeover quality', 'moderate workload level']","[{'cui': 'C0684312', 'cui_str': 'Vehicle driver'}]",[],"[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",50.0,0.0299729,"The moderate workload level (rather than the lower or higher workload level) led to a faster and better takeover performance, and it seemed to require minimal lead time for drivers.","[{'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': 'Department of Psychology, Zhejiang Sci-Tech University, Hangzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychology, Zhejiang Sci-Tech University, Hangzhou, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Psychology, Zhejiang Sci-Tech University, Hangzhou, China.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Kang', 'Affiliation': 'Department of Psychology, Zhejiang Sci-Tech University, Hangzhou, China.'}, {'ForeName': 'Changxu', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Chunlei', 'Initials': 'C', 'LastName': 'Chai', 'Affiliation': 'State Key Lab of CAD&CG, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Jinlei', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Psychology, Zhejiang Sci-Tech University, Hangzhou, China.'}, {'ForeName': 'Hongting', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Psychology, Zhejiang Sci-Tech University, Hangzhou, China.'}]",Traffic injury prevention,['10.1080/15389588.2020.1804060'] 1242,33241721,Time course of efficacy of ubrogepant for the acute treatment of migraine: Clinical implications.,"BACKGROUND The full utility of an acute treatment requires examination of the entire time course of effect during a migraine attack. Here the time course of effect of ubrogepant is evaluated. METHODS ACHIEVE-I and -II were double-blind, single-attack, Phase 3 trials. Adults with migraine were randomised 1:1:1 to placebo or ubrogepant (50mg or 100mg, ACHIEVE-I; 25 mg or 50 mg, ACHIEVE-II). Pain freedom, absence of most bothersome symptom, and pain relief were assessed at various timepoints. Samples were collected for pharmacokinetic analysis. Data were pooled for this post-hoc analysis. RESULTS Participants' (n = 912 placebo, n = 887 ubrogepant 50 mg, pooled analysis population) mean age was 41 years, with a majority female and white. Pain relief separated from placebo by 1 h (43% versus 37% [OR, 95% CI: 1.30, 1.0-1.59]), absence of most bothersome symptom by 1.5 h (28% versus 22% [1.42, 1.14-1.77]), and pain freedom by 2 h (20% vs. 13% [1.72, 1.33-2.22]). Efficacy was sustained from 2-24 h (pain relief: 1.71, 1.1-2.6; pain freedom: 1.71, 1.3-2.3) and remained separated at 48 h (pain relief: 1.7, 1.1-2.6; pain freedom: 1.31, 1.0-1.7). Pharmacokinetic analysis demonstrated maximum plasma concentrations were achieved at 1 h, with pharmacologically active concentrations reached within 11 min and remaining above the EC 90 for nearly 12 h. CONCLUSIONS Evaluation of the time course of effect of ubrogepant showed pain relief as the most sensitive and earliest measure of clinical effect, followed by absence of most bothersome symptom, and pain freedom. Efficacy was demonstrated out to 48 h, providing evidence of the long-lasting effect of ubrogepant. This evaluation supports the role of examining the entire time course of effect to understand fully the utility of an acute treatment for migraine. Trial registration: ACHIEVE I (ClinicalTrials.gov, NCT02828020) and ACHIEVE II (ClinicalTrials.gov, NCT02867709).",2021,"Efficacy was sustained from 2-24 h (pain relief: 1.71, 1.1-2.6; pain freedom: 1.71, 1.3-2.3) and remained separated at 48 h (pain relief: 1.7, 1.1-2.6; pain freedom: 1.31, 1.0-1.7).","['Adults with migraine', 'mean age was 41 years, with a majority female and white']","['placebo or ubrogepant', 'placebo']","['pain relief', 'pain freedom', 'Efficacy', 'Pain relief', 'absence of most bothersome symptom', 'maximum plasma concentrations', 'Pain freedom, absence of most bothersome symptom, and pain relief']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4505936', 'cui_str': 'ubrogepant'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.302283,"Efficacy was sustained from 2-24 h (pain relief: 1.71, 1.1-2.6; pain freedom: 1.71, 1.3-2.3) and remained separated at 48 h (pain relief: 1.7, 1.1-2.6; pain freedom: 1.31, 1.0-1.7).","[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""NIHR-Wellcome Trust King's Clinical Research Facility, SLaM Biomedical Research Centre, King's College London, London, UK.""}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Blumenfeld', 'Affiliation': 'Headache Center of Southern California, Carlsbad, CA, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'Albert Einstein College of Medicine and Montefiore Headache Center, Bronx, NY, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': 'Mayo Clinic, Phoenix, AZ, USA.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Kalidas', 'Affiliation': 'University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Aubrey', 'Initials': 'A', 'LastName': 'M Adams', 'Affiliation': 'AbbVie, Irvine, CA, USA.'}, {'ForeName': 'Abhijeet', 'Initials': 'A', 'LastName': 'Jakate', 'Affiliation': 'AbbVie, Madison, NJ, USA.'}, {'ForeName': 'Chengcheng', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'AbbVie, Madison, NJ, USA.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Szegedi', 'Affiliation': 'AbbVie, Madison, NJ, USA.'}, {'ForeName': 'Joel M', 'Initials': 'JM', 'LastName': 'Trugman', 'Affiliation': 'AbbVie, Madison, NJ, USA.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102420970523'] 1243,32783220,Microcurrent electrotherapy improves palatal wound healing: Randomized clinical trial.,"BACKGROUND This study was conducted to assess the clinical, immunological, and patient-centered outcomes of microcurrent electrotherapy on palatal wound healing. METHODS This was a parallel, double-masked randomized clinical trial, in which 53 patients with ridge preservation indications were selected and randomly assigned to one of two groups. In the control (sham) group (n = 27), palatal wounds, after free gingival grafts (FGG) harvest, received sham application of electrotherapy. In the test (electrotherapy treatment [EE]) group (n = 26), palatal wounds, after FGG harvest, received application of microcurrent electrotherapy protocol. Clinical parameters, patient-centered outcomes, and inflammatory markers were evaluated, up to 90 days postoperatively. RESULTS The EE group achieved earlier wound closure (P <0.001) and epithelialization (P <0.05; P = 0.03) at 7 and 14 days after harvest when compared with the sham group. Painful symptomatology was reported less frequently in the EE group than in the sham group at 3-day follow-up (P = 0.008). Likewise, an improvement in Oral Health Impact Profile was reported 2 days after the procedure by the EE group (P = 0.04). In addition, favorable modulation of inflammatory wound healing markers occurred when electrotherapy was applied. CONCLUSION Within the limits of the present study, it can be concluded that the use of a low-intensity electrotherapy protocol may accelerate palatal wound healing and decrease patient discomfort after FGG harvest.",2021,Painful symptomatology was reported less frequently in the EE group than in the Sham group at 3-day follow-up (p = 0.008).,['53 patients with ridge preservation indications'],"['microcurrent electrotherapy protocol', 'electrotherapy', 'Microcurrent electrotherapy', 'microcurrent electrotherapy']","['earlier wound closure', 'palatal wound healing', 'Painful symptomatology', 'inflammatory wound healing markers', 'epithelialization', 'Oral Health Impact Profile (OHIP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}]","[{'cui': 'C0013787', 'cui_str': 'Electrotherapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0334029', 'cui_str': 'Epithelialization'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]",53.0,0.134584,Painful symptomatology was reported less frequently in the EE group than in the Sham group at 3-day follow-up (p = 0.008).,"[{'ForeName': 'Manuela Maria Viana', 'Initials': 'MMV', 'LastName': 'Miguel', 'Affiliation': 'Division of Periodontics, Unesp - São Paulo State University, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}, {'ForeName': 'Ingrid Fernandes', 'Initials': 'IF', 'LastName': 'Mathias-Santamaria', 'Affiliation': 'Division of Periodontics, Unesp - São Paulo State University, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Rossato', 'Affiliation': 'Division of Periodontics, Unesp - São Paulo State University, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}, {'ForeName': 'Laís Fernanda Ferreira', 'Initials': 'LFF', 'LastName': 'Ferraz', 'Affiliation': 'Division of Periodontics, Unesp - São Paulo State University, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}, {'ForeName': 'Antônio Martins', 'Initials': 'AM', 'LastName': 'Figueiredo-Neto', 'Affiliation': 'National Institute of Science and Technology-Complex Fluids, São Paulo, Brazil.'}, {'ForeName': 'Andrea Carvalho', 'Initials': 'AC', 'LastName': 'de Marco', 'Affiliation': 'Division of Periodontics, Unesp - São Paulo State University, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}, {'ForeName': 'Renato Corrêa Viana', 'Initials': 'RCV', 'LastName': 'Casarin', 'Affiliation': 'Department of Prosthodontics and Periodontics, Division of Periodontics, University of Campinas Piracicaba Dental School Piracicaba, São Paulo, Brazil.'}, {'ForeName': 'Shannon Margaret', 'Initials': 'SM', 'LastName': 'Wallet', 'Affiliation': 'School of Dentistry, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Dimitris N', 'Initials': 'DN', 'LastName': 'Tatakis', 'Affiliation': 'College of Dentistry, Division of Periodontology, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Marcio Antonio', 'Initials': 'MA', 'LastName': 'Mathias', 'Affiliation': 'FEI University, Department of Electrical Engineering, São Bernardo do Campo, São Paulo, Brazil.'}, {'ForeName': 'Mauro Pedrine', 'Initials': 'MP', 'LastName': 'Santamaria', 'Affiliation': 'Division of Periodontics, Unesp - São Paulo State University, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}]",Journal of periodontology,['10.1002/JPER.20-0122'] 1244,32789503,Hippocampal avoidance whole-brain radiotherapy without memantine in preserving neurocognitive function for brain metastases: a phase II blinded randomized trial.,"BACKGROUND Hippocampal avoidance whole-brain radiotherapy (HA-WBRT) shows potential for neurocognitive preservation. This study aimed to evaluate whether HA-WBRT or conformal WBRT (C-WBRT) is better for preserving neurocognitive function. METHODS This single-blinded randomized phase II trial enrolled patients with brain metastases and randomly assigned them to receive HA-WBRT or C-WBRT. Primary endpoint is decline of the Hopkins Verbal Learning Test-Revised (HVLT-R) delayed recall at 4 months after treatment. Neurocognitive function tests were analyzed with a mixed effect model. Brain progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan-Meier method. RESULTS From March 2015 to December 2018, seventy patients were randomized to yield a total cohort of 65 evaluable patients (33 in the HA-WBRT arm and 32 in the C-WBRT arm) with a median follow-up of 12.4 months. No differences in baseline neurocognitive function existed between the 2 arms. The mean change of HVLT-R delayed recall at 4 months was -8.8% in the HA-WBRT arm and +3.8% in the C-WBRT arm (P = 0.31). At 6 months, patients receiving HA-WBRT showed favorable perpetuation of HVLT-R total recall (mean difference = 2.60, P = 0.079) and significantly better preservation of the HVLT-R recognition-discrimination index (mean difference = 1.78, P = 0.019) and memory score (mean difference = 4.38, P = 0.020) compared with patients undergoing C-WBRT. There were no differences in Trail Making Test Part A or Part B or the Controlled Oral Word Association test between the 2 arms at any time point. There were no differences in brain PFS or OS between arms as well. CONCLUSION Patients receiving HA-WBRT without memantine showed better preservation in memory at 6-month follow-up, but not in verbal fluency or executive function.",2021,"There were no differences in TMT part A, part B, or the COWA test between the two arms at any time point.","['enrolled patients with brain metastases', 'From March 2015 to December 2018, seventy patients were randomized to yield a total cohort of 65 evaluable patients (33 in the HA-WBRT arm and 32 in the C-WBRT arm) with a median follow-up of 12.4 months', 'Brain Metastases']","['HA-WBRT or C-WBRT', 'Hippocampal avoidance whole-brain radiotherapy (HA-WBRT', 'memantine', 'Hippocampal Avoidance Whole-brain Radiotherapy without Memantine', 'HA-WBRT or conformal WBRT (C-WBRT']","['Brain progression free survival (BPFS) and overall survival (OS', 'Neurocognitive function tests', 'memory score', 'HVLT-R recognition-discrimination index', 'verbal fluency or executive function', 'decline of Hopkins Verbal Learning Test-Revised (HVLT-R) Delayed Recall', 'favorable perpetuation of HVLT-R total recall', 'TMT part A, part B, or the COWA test', 'BPFS or OS', 'baseline neurocognitive function', 'mean change of HVLT-R delayed recall']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C1520143', 'cui_str': 'Whole brain radiation therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0026377', 'cui_str': 'Molecular conformation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517543', 'cui_str': '12.4'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C1520143', 'cui_str': 'Whole brain radiation therapy'}, {'cui': 'C0026377', 'cui_str': 'Molecular conformation'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040604', 'cui_str': 'Trail making test'}, {'cui': 'C3827022', 'cui_str': 'Controlled Oral Word Association Test'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",70.0,0.171341,"There were no differences in TMT part A, part B, or the COWA test between the two arms at any time point.","[{'ForeName': 'Wen-Chi', 'Initials': 'WC', 'LastName': 'Yang', 'Affiliation': 'Division of Radiation Oncology, Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ya-Fang', 'Initials': 'YF', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Imaging, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chi-Cheng', 'Initials': 'CC', 'LastName': 'Yang', 'Affiliation': 'Department of Psychology, National Chengchi University, Taipei, Taiwan.'}, {'ForeName': 'Pei-Fang', 'Initials': 'PF', 'LastName': 'Wu', 'Affiliation': 'Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Hsing-Min', 'Initials': 'HM', 'LastName': 'Chan', 'Affiliation': 'Division of Radiation Oncology, Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Jenny Ling-Yu', 'Initials': 'JL', 'LastName': 'Chen', 'Affiliation': 'Division of Radiation Oncology, Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Guann-Yiing', 'Initials': 'GY', 'LastName': 'Chen', 'Affiliation': 'Division of Radiation Oncology, Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Jason Chia-Hsien', 'Initials': 'JC', 'LastName': 'Cheng', 'Affiliation': 'Division of Radiation Oncology, Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Sung-Hsin', 'Initials': 'SH', 'LastName': 'Kuo', 'Affiliation': 'Division of Radiation Oncology, Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Feng-Ming', 'Initials': 'FM', 'LastName': 'Hsu', 'Affiliation': 'Division of Radiation Oncology, Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan.'}]",Neuro-oncology,['10.1093/neuonc/noaa193'] 1245,32790904,Vortioxetine versus other antidepressants in the treatment of burning mouth syndrome: An open-label randomized trial.,"OBJECTIVES This randomized open-label trial compared the efficacy and tolerability of vortioxetine (15 mg/daily) with different antidepressants in the treatment of patients with burning mouth syndrome (BMS). METHODS One and hundred fifty BMS patients were randomized into five groups and treated with either vortioxetine, paroxetine (20 mg/daily), sertraline (50 mg/daily), escitalopram (10 mg/daily) or duloxetine (60 mg/daily). The Visual Analogue Scale (VAS), Total Pain Rating Index (T-PRI), Hamilton Rating Scales for Depression (HAM-D) and Anxiety (HAM-A), and Clinical Global Impression Improvement (CGI-I) and Efficacy scales (CGI-E) were performed at baseline and after 2, 4, 6, and 12 months of treatment. Any adverse events (AEs) were tabulated for each group. Descriptive statistics, including the Kruskal-Wallis non-parametric test and the Friedman non-parametric test for median comparisons between different times, were used. RESULTS All the antidepressants (AD) were associated with a significant decrease in the VAS, T-PRI, HAM-A, HAM-D, CGI-I, and CGI-E scores in the long-term (p < .001). However, the response rate of the vortioxetine group showed a significant reduction after six months. The medians, after 6 months, were as follows: VAS 0.0; T-PRI 2.0; HAM-A 7.0; HAM-D 7.0; CGI-I 1.0; and CGI-E 1.0 with a lower incidence of AEs (p < .019). CONCLUSION Vortioxetine was efficacious with a shorter latency of action and fewer AEs compared with other ADs.",2021,"All the antidepressants (AD) were associated with a significant decrease in the VAS, T-PRI, HAM-A, HAM-D, CGI","['patients with Burning Mouth Syndrome (BMS', '150 BMS patients', 'Burning Mouth Syndrome']","['vortioxetine', 'vortioxetine, paroxetine', 'sertraline', 'Vortioxetine', 'escitalopram (10 mg/ daily) or duloxetine']","['I and CGI-E scores', 'Visual Analogue Scale (VAS), Total Pain Rating Index (T-PRI), Hamilton Rating Scales for Depression (HAM-D) and Anxiety (HAM-A) and Clinical Global Impression Improvement (CGI-I) and Efficacy scales (CGI-E', 'VAS, T-PRI, HAM-A, HAM-D, CGI', 'efficacy and tolerability', 'response rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006430', 'cui_str': 'Burning mouth syndrome'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C3661282', 'cui_str': 'vortioxetine'}, {'cui': 'C0070122', 'cui_str': 'Paroxetine'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0245561', 'cui_str': 'duloxetine'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",150.0,0.0555323,"All the antidepressants (AD) were associated with a significant decrease in the VAS, T-PRI, HAM-A, HAM-D, CGI","[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Adamo', 'Affiliation': 'Department of Neurosciences, Reproductive and Odontostomatological Sciences, University Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pecoraro', 'Affiliation': 'Department of Neurosciences, Reproductive and Odontostomatological Sciences, University Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Noemi', 'Initials': 'N', 'LastName': 'Coppola', 'Affiliation': 'Department of Neurosciences, Reproductive and Odontostomatological Sciences, University Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Calabria', 'Affiliation': 'Department of Neurosciences, Reproductive and Odontostomatological Sciences, University Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Aria', 'Affiliation': 'Department of Economics and Statistics, University Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Mignogna', 'Affiliation': 'Department of Neurosciences, Reproductive and Odontostomatological Sciences, University Federico II of Naples, Naples, Italy.'}]",Oral diseases,['10.1111/odi.13602'] 1246,32790913,Non-impacted tooth extractions and antibiotic treatment: A RCT study.,"OBJECTIVES A controlled, single-blind, randomized clinical trial was performed to evaluate usefulness of antibiotics in preventing pain and complications after tooth extractions and benefits of probiotics in reducing gastro-intestinal symptoms associated with antibiotic therapy. MATERIALS AND METHODS A total of 159 patients were enrolled in this trial. After tooth extractions, patients were allocated to one of the groups: group 1 received postoperatively amoxicillin + clavulanic acid; group 2 received the same antibiotic therapy with an adjunctive probiotic treatment; and group 3 received neither antibiotics nor probiotics. Follow-up visits were planned at 7, 14, and 21 days after tooth extractions (T1, T2, and T3), and parameters assessed were pain, presence of abscess, edema, fever, alveolitis, trismus, pain, difficulty in daily routine activities, and gastro-intestinal symptoms. RESULTS The number of patients reporting pain at T1 was significantly higher in the control group when compared to group 2 (p = .016), while no difference for pain intensity was observed between groups. No surgical site infection was observed in any of the groups. Intestinal symptoms seemed to be tackled by probiotic administration. CONCLUSIONS Pain was the most important symptom in the control group. Antibiotics were not necessary after non-impacted tooth extractions, and probiotics can reduce gastro-intestinal symptoms associated with antibiotics.",2021,"The number of patients reporting pain at T1 was significantly higher in the control group when compared to group 2 (p=0.016), whilst no difference for pain intensity was observed between groups.",[' 159 patients were enrolled in this trial'],"['antibiotics', 'antibiotic therapy with an adjunctive probiotic treatment; group 3 received neither antibiotics nor probiotics', 'post-operatively amoxicillin + clavulanic acid']","['gastro-intestinal symptoms', 'Intestinal symptoms', 'pain, presence of abscess, oedema, fever, alveolitis, trismus, pain, difficulty in daily routine activities and gastro-intestinal symptoms', 'pain intensity', 'pain and complications', 'surgical site infection', 'number of patients reporting pain at T1']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0054066', 'cui_str': 'Amoxicillin and clavulanate'}]","[{'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0549493', 'cui_str': 'Alveolitis'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",159.0,0.0839699,"The number of patients reporting pain at T1 was significantly higher in the control group when compared to group 2 (p=0.016), whilst no difference for pain intensity was observed between groups.","[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cinquini', 'Affiliation': 'University of Pisa - Department of Surgical, Medical, Molecular and Critical Area Pathology, University-Hospital of Pisa, Pisa, Italy.'}, {'ForeName': 'Saverio', 'Initials': 'S', 'LastName': 'Marchionni', 'Affiliation': 'University of Pisa - Department of Surgical, Medical, Molecular and Critical Area Pathology, University-Hospital of Pisa, Pisa, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Derchi', 'Affiliation': 'University of Pisa - Department of Surgical, Medical, Molecular and Critical Area Pathology, University-Hospital of Pisa, Pisa, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Miccoli', 'Affiliation': 'University of Pisa - Department of Clinical and Experimental Medicine, University-Hospital of Pisa, Pisa, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Gabriele', 'Affiliation': 'University of Pisa - Department of Surgical, Medical, Molecular and Critical Area Pathology, University-Hospital of Pisa, Pisa, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Barone', 'Affiliation': 'University of Pisa - Department of Surgical, Medical, Molecular and Critical Area Pathology, University-Hospital of Pisa, Pisa, Italy.'}]",Oral diseases,['10.1111/odi.13607'] 1247,32804248,Locking versus non-locking plates in fixation of extra-articular distal humerus fracture: a randomized controlled study.,"INTRODUCTION Studies have shown that the use of nonlocking (reconstruction) plates in fixing distal humerus fractures may not yield stable fixation which therefore requires long immobilization and suboptimal functional results. There are reports showing that locking plates are biomechanically superior to nonlocking plates. The aim of this study was to compare elbow functional outcomes between locking and nonlocking plates in fixation of distal humerus fractures. METHODS A single-centre, randomized control study was conducted at an academic level 1 trauma centre. A total of 60 patients with type 13-A fracture (AO/OTA classification) were randomized into two equal groups, locking plates group, and nonlocking plates group. The primary outcome measure was the Mayo elbow performance score (MEPS) at one year. Secondary outcomes measures were elbow flexion/extension arc, union, operative time, and complications (e.g., infection, heterotrophic ossification). RESULTS The Mayo Elbow Performance Score (MEPS) at one year was 88 ± 10.1 in locking plates group and 75.8 ± 12.8 in nonlocking plates group. The difference was found to be statically significant (P value = 0.01). Elbow flexion/extension arc of motion at one year was 116° ± 15° in locking plates group and 113° ± 28° in nonlocking plates. The difference was not found to be statistically significant (P value = 0.17). CONCLUSION Both implants yield similar results, with locking plates showing slightly better clinical scores.",2020,The Mayo Elbow Performance Score (MEPS) at one year was 88 ± 10.1 in locking plates group and 75.8 ± 12.8 in nonlocking plates group.,"['A single-centre, randomized control study was conducted at an academic level 1 trauma centre', 'extra-articular distal humerus fracture', '60 patients with type 13-A fracture (AO/OTA classification']","['locking plates group, and nonlocking plates group', 'Elbow flexion/extension arc of motion at one year was\xa0116° ± 15', 'nonlocking (reconstruction) plates', 'locking and nonlocking plates', 'Locking versus non-locking plates']","['elbow flexion/extension arc, union, operative time, and complications (e.g., infection, heterotrophic ossification', 'elbow functional outcomes', 'Mayo Elbow Performance Score (MEPS', 'Mayo elbow performance score (MEPS']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0205135', 'cui_str': 'Extra-articular'}, {'cui': 'C0588211', 'cui_str': 'Bone structure of distal humerus'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0069299', 'cui_str': 'ochratoxin A'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]","[{'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0444509', 'cui_str': 'Flexion/extension'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C4517541', 'cui_str': '116'}]","[{'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0444509', 'cui_str': 'Flexion/extension'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.0449834,The Mayo Elbow Performance Score (MEPS) at one year was 88 ± 10.1 in locking plates group and 75.8 ± 12.8 in nonlocking plates group.,"[{'ForeName': 'Sherif', 'Initials': 'S', 'LastName': 'Galal', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine, Cairo University, Cairo, P. O 11559, Egypt. Sherif.Galal@kasralainy.edu.eg.'}, {'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Mattar', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine, Cairo University, Cairo, P. O 11559, Egypt.'}, {'ForeName': 'Alaa Mohy Eldin', 'Initials': 'AME', 'LastName': 'Solyman', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine, Cairo University, Cairo, P. O 11559, Egypt.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Ezzat', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine, Cairo University, Cairo, P. O 11559, Egypt.'}]",International orthopaedics,['10.1007/s00264-020-04770-z'] 1248,32822692,Effect of early and late prenatal vitamin D and maternal asthma status on offspring asthma or recurrent wheeze.,"BACKGROUND Childhood asthma developmental programming is complex. Maternal asthma is a strong risk factor for childhood asthma, whereas vitamin D (VD) has emerged as a modifiable prenatal exposure. OBJECTIVE Our aim was to examine the combined effect of early and late prenatal VD status in during pregnancies in women with and without asthma on childhood asthma or recurrent wheeze development. METHODS We conducted a cohort study using prospectively collected data from the Vitamin D Antenatal Asthma Reduction Trial, a randomized, double-blinded, placebo-controlled VD supplementation trial in pregnant women at high risk of offspring asthma (N = 806 mother-offspring pairs). 25-Hydroxyvitamin-D (25(OH)D) level was measured in early and late pregnancy. Our main exposure was an ordered variable representing early and late prenatal VD sufficiency (25(OH)D level ≥ 30 ng/mL) status during pregnancy in women with and without asthma. The primary outcome was offspring with asthma or recurrent wheeze by age 3 years. We also examined the effect of prenatal VD level on early life asthma or recurrent wheeze progression to active asthma at age 6 years. RESULTS Among mothers with asthma versus among mothers with early and late prenatal VD insufficiency, those with early or late VD sufficiency (adjusted odds ratio = 0.56; 95% CI = 0.31-1.00) or early and late VD sufficiency (adjusted odds ratio = 0.36; 95% CI = 0.15-0.81) had a lower risk of offspring with asthma or recurrent wheeze by age 3 years (P for trend  = .008). This protective trend was reiterated in asthma or recurrent wheeze progression to active asthma from age 3 to 6 years (P for   trend  = .04). CONCLUSION This study implies a protective role for VD sufficiency throughout pregnancy, particularly in attenuating the risk conferred by maternal asthma on childhood asthma or recurrent wheeze development.",2021,"This protective trend was reiterated in asthma/recurrent wheeze progression to active asthma from age 3 to 6 years (P for trend =0.04). ","['early life asthma/recurrent wheeze progression to active asthma at age 6 years', 'pregnant women at high risk of offspring asthma (N=806 mother-offspring pairs', 'pregnancies with and without asthma on childhood asthma/recurrent wheeze development', 'asthmatic pregnant women', 'offspring asthma or recurrent wheeze', 'pregnancies with and without asthma']","['early and late prenatal vitamin D', 'Vitamin D Antenatal Asthma Reduction Trial (VDAART', 'prenatal VD', 'placebo-controlled vitamin D supplementation']","['25-hydroxyvitamin-D [25(OH)D', 'offspring asthma or recurrent wheeze by age 3 years', 'lower risk of offspring asthma/recurrent wheeze']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0264408', 'cui_str': 'Childhood asthma'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0772413', 'cui_str': 'Prenatal vitamin'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}]",,0.10878,"This protective trend was reiterated in asthma/recurrent wheeze progression to active asthma from age 3 to 6 years (P for trend =0.04). ","[{'ForeName': 'Mengdi', 'Initials': 'M', 'LastName': 'Lu', 'Affiliation': ""Division of Pediatric Pulmonary Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Mass; Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass.""}, {'ForeName': 'Augusto A', 'Initials': 'AA', 'LastName': 'Litonjua', 'Affiliation': ""Division of Pediatric Pulmonary Medicine, Golisano Children's Hospital at University of Rochester Medical Center, Rochester, NY.""}, {'ForeName': 'George T', 'Initials': 'GT', 'LastName': ""O'Connor"", 'Affiliation': 'Pulmonary Center, Department of Medicine, Boston Medical Center, Boston University, Boston, Mass.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Zeiger', 'Affiliation': 'Department of Allergy and Research and Evaluation, Kaiser Permanente Southern California Region, San Diego and Pasadena, Calif.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Bacharier', 'Affiliation': 'Division of Pediatric Allergy, Immunology and Pulmonary Medicine, Department of Pediatrics, Washington University, St Louis, Mo.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schatz', 'Affiliation': 'Division of Pediatric Allergy, Immunology and Pulmonary Medicine, Department of Pediatrics, Washington University, St Louis, Mo.'}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Carey', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass.""}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Weiss', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass.""}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Mirzakhani', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass. Electronic address: hoomi@post.harvard.edu.""}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.06.041'] 1249,32830625,The role of improved social support for healthy eating in a lifestyle intervention: Texercise Select .,"OBJECTIVE We examined the measurement and mediating role of social support in dietary intake among participants in Texercise Select, an intervention for improving lifestyle behaviours. DESIGN Quasi-experimental study. Participants reported their dietary intake, level of social support measured by the new Social Support for Healthy Eating scale, sociodemographics and disease profile. We conducted exploratory factor analysis for scale evaluation and structural equation modelling for mediation analysis to test if changes in dietary-specific social support mediate the relationship between the intervention and changes in dietary intake. SETTING Texas. PARTICIPANTS Community-dwelling middle-aged and older adults completed a self-reported survey at baseline and 3-month follow-up (intervention group n 211, comparison group n 175). RESULTS The majority of the sample was aged ≥70 years (mean 74·30, sd 8·54), female (82·1 %) and had at least two chronic conditions (63·5 %). The acceptable levels of reliability and validity of the dietary-specific social support scale were confirmed. Compared with the comparison group, the intervention group reported improved intake of fruit/vegetables and water, and improved dietary-specific social support. Improved dietary-specific social support mediated the association between intervention and change in fruit/vegetable intake, controlling for sociodemographics, number of chronic conditions and geographic residence. About 12 % of intervention effect was mediated by social support. CONCLUSIONS The current study confirms positive intervention effects on healthy eating, and highlights social support relating to dietary behaviours that may be helpful for healthy eating. Future research should investigate additional social support for developing healthy eating behavioural skills.",2021,"Improved dietary-specific social support mediated the association between intervention and change in fruit/vegetable intake, controlling for sociodemographics, number of chronic conditions and geographic residence.","['The majority of the sample was aged ≥70 years (mean 74·30', 'healthy eating in a lifestyle intervention', 'healthy eating', 'Community-dwelling middle-aged and older adults completed a self-reported survey at baseline and 3-month follow-up (intervention group n 211, comparison group n 175', 'sd 8·54), female (82·1 %) and had at least two chronic conditions (63·5 ', 'Texas']",[],"['reliability and validity of the dietary-specific social support scale', 'dietary intake, level of social support measured by the new Social Support for Healthy Eating scale, sociodemographics and disease profile', 'intake of fruit/vegetables and water, and improved dietary-specific social support']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0026062', 'cui_str': 'Middle-age'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0441848', 'cui_str': 'Group N'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0039711', 'cui_str': 'Texas'}]",[],"[{'cui': 'C0035036', 'cui_str': 'Reliability and Validity'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",,0.0160207,"Improved dietary-specific social support mediated the association between intervention and change in fruit/vegetable intake, controlling for sociodemographics, number of chronic conditions and geographic residence.","[{'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Yoshikawa', 'Affiliation': 'Center for Population Health and Aging, School of Public Health, Texas A&M University, 212 Adriance Lab Road, 1266 TAMU, Suite 360, College Station, TX77843-1266, USA.'}, {'ForeName': 'Matthew Lee', 'Initials': 'ML', 'LastName': 'Smith', 'Affiliation': 'Center for Population Health and Aging, School of Public Health, Texas A&M University, 212 Adriance Lab Road, 1266 TAMU, Suite 360, College Station, TX77843-1266, USA.'}, {'ForeName': 'Shinduk', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Center for Population Health and Aging, School of Public Health, Texas A&M University, 212 Adriance Lab Road, 1266 TAMU, Suite 360, College Station, TX77843-1266, USA.'}, {'ForeName': 'Samuel D', 'Initials': 'SD', 'LastName': 'Towne', 'Affiliation': 'Center for Population Health and Aging, School of Public Health, Texas A&M University, 212 Adriance Lab Road, 1266 TAMU, Suite 360, College Station, TX77843-1266, USA.'}, {'ForeName': 'Marcia G', 'Initials': 'MG', 'LastName': 'Ory', 'Affiliation': 'Center for Population Health and Aging, School of Public Health, Texas A&M University, 212 Adriance Lab Road, 1266 TAMU, Suite 360, College Station, TX77843-1266, USA.'}]",Public health nutrition,['10.1017/S1368980020002700'] 1250,33231278,Return to Sport and Work after Randomization for Knee Distraction versus High Tibial Osteotomy: Is There a Difference?,"Knee joint distraction (KJD) is a novel technique for relatively young knee osteoarthritis (OA) patients. With KJD, an external distraction device creates temporary total absence of contact between cartilage surfaces, which results in pain relief and possibly limits the progression of knee OA. Recently, KJD showed similar clinical outcomes compared with high tibial osteotomy (HTO). Yet, no comparative data exist regarding return to sport (RTS) and return to work (RTW) after KJD. Therefore, our aim was to compare RTS and RTW between KJD and HTO. We performed a cross-sectional follow-up study in patients <65 years who previously participated in a randomized controlled trial comparing KJD and HTO. Out of 62 eligible patients, 55 patients responded and 51 completed the questionnaire (16 KJDs and 35 HTOs) at 5-year follow-up. The primary outcome measures were the percentages of RTS and RTW. Secondary outcome measures included time to RTS/RTW, and pre- and postoperative Tegner's (higher is more active), and Work Osteoarthritis or Joint-Replacement Questionnaire (WORQ) scores (higher is better work ability). Patients' baseline characteristics did not differ. Total 1 year after KJD, 79% returned to sport versus 80% after HTO (not significant [n.s.]). RTS <6 months was 73 and 75%, respectively (n.s.). RTW 1 year after KJD was 94 versus 97% after HTO (n.s.), and 91 versus 87% <6 months (n.s.). The median Tegner's score decreased from 5.0 to 3.5 after KJD, and from 5.0 to 3.0 after HTO (n.s.). The mean WORQ score improvement was higher after HTO (16 ± 16) than after KJD (6 ± 13; p  = 0.04). Thus, no differences were found for sport and work participation between KJD and HTO in our small, though first ever, cohort. Overall, these findings may support further investigation into KJD as a possible joint-preserving option for challenging ""young"" knee OA patients. The level of evidence is III.",2020,"The median Tegner's score decreased from 5.0 to 3.5 after KJD, and from 5.0 to 3.0 after HTO (n.s.).","['relatively young knee osteoarthritis (OA) patients', '62 eligible patients, 55 patients responded and 51 completed the questionnaire (16 KJDs and 35 HTOs) at 5-year follow-up', 'patients <65 years who previously participated']","['Knee Distraction versus High Tibial Osteotomy', 'KJD and HTO', 'high tibial osteotomy (HTO', 'KJD', 'Knee joint distraction (KJD']","['pain relief', ""median Tegner's score"", ""time to RTS/RTW, and pre- and postoperative Tegner's (higher is more active), and Work Osteoarthritis or Joint-Replacement Questionnaire (WORQ) scores"", 'percentages of RTS and RTW', 'mean WORQ score improvement']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0187826', 'cui_str': 'Osteotomy of tibia'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0185317', 'cui_str': 'Implantation of joint prosthesis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",62.0,0.0503786,"The median Tegner's score decreased from 5.0 to 3.5 after KJD, and from 5.0 to 3.0 after HTO (n.s.).","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hoorntje', 'Affiliation': 'Department of Orthopaedic Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam Movement Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'P Paul F M', 'Initials': 'PPFM', 'LastName': 'Kuijer', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Coronel Institute of Occupational Health, Amsterdam Public Health Research Institute, Amsterdam Movement Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Koen L M', 'Initials': 'KLM', 'LastName': 'Koenraadt', 'Affiliation': 'Department of Orthopaedic Surgery, Foundation FORCE (Foundation for Orthopaedic Research Care and Education), Amphia Hospital, Breda, The Netherlands.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Waterval-Witjes', 'Affiliation': 'Academic Center for Evidence-Based Sports Medicine, Amsterdam, The Netherlands.'}, {'ForeName': 'Gino M M J', 'Initials': 'GMMJ', 'LastName': 'Kerkhoffs', 'Affiliation': 'Department of Orthopaedic Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam Movement Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Simon C', 'Initials': 'SC', 'LastName': 'Mastbergen', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Anne C A', 'Initials': 'ACA', 'LastName': 'Marijnissen', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Mylène P', 'Initials': 'MP', 'LastName': 'Jansen', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Rutger C I', 'Initials': 'RCI', 'LastName': 'van Geenen', 'Affiliation': 'Department of Orthopaedic Surgery, Foundation FORCE (Foundation for Orthopaedic Research Care and Education), Amphia Hospital, Breda, The Netherlands.'}]",The journal of knee surgery,['10.1055/s-0040-1721027'] 1251,32803709,"The Metabolic Effects of Pre-probiotic Supplementation After Roux-en-Y Gastric Bypass (RYGB) Surgery: a Prospective, Randomized Controlled Study.","PURPOSE Following Roux-en-Y gastric bypass (RYGB), positive alterations are observed in gut microbiota and intestinal peptides. Previous studies demonstrated similar alterations observed in cases when pre-probiotics are used without surgery. The aim of this trial was to evaluate the effectiveness of early use of pre-probiotics after RYGB. MATERIAL AND METHODS The operation and follow-up of the patients were performed at Istanbul University Medical Faculty. Thirty-two patients who had undergone RYGB were randomized to pre-probiotic group (PreProBG, n = 16; 200 g/day yogurt plus 10 g/day inulin+oligofructose) and probiotic group (ProBG, n = 16; 200 g/day yogurt only) for 6 months. Blood samples (glucose, insulin, A1c, GLP-1, PYY), anthropometric measurements, and appetite ratings have been evaluated at baseline and 3 (m3) and 6 (m6) months after RYGB. RESULTS Initial anthropometric measurements and appetite ratings decreased significantly after surgery and there were no significant differences between the groups. The decrease of area under the curve(insulin) was less and has a positive correlation with the changes in anthropometric measurements in PreProBG. GLP-1 and PYY which increased dramatically after surgery in all patients were higher in PreProBG. But this increase had a negative correlation with the changes in anthropometric measurements during the study. CONCLUSION Increased insulin, GLP-1, and PYY secretion was more enhanced by pre-probiotic use in early postoperative period. But this increase not only in anthropometric measurements but also in appetite ratings affects negatively, contrary to expectations. In summary, it should be investigated with new studies that use of pre-probiotics in the late postoperative period may be more effective in patients with weak insulin and incretin response and therefore insufficient weight loss. Trial Registration clinicaltrials.gov Identifier: NCT03517345.",2021,The decrease of area under the curve(insulin) was less and has a positive correlation with the changes in anthropometric measurements in PreProBG.,"['The operation and follow-up of the patients were performed at Istanbul University Medical Faculty', 'Thirty-two patients who had undergone RYGB']","['Pre-probiotic Supplementation After Roux-en-Y Gastric Bypass (RYGB', 'pre-probiotic group (PreProBG, n\u2009=\u200916; 200\xa0g/day yogurt plus 10\xa0g/day inulin+oligofructose) and probiotic group (ProBG', 'Roux-en-Y gastric bypass (RYGB']","['insulin, GLP-1, and PYY secretion', 'Initial anthropometric measurements and appetite ratings', 'Blood samples (glucose, insulin, A1c, GLP-1, PYY), anthropometric measurements, and appetite ratings', 'decrease of area under the curve(insulin']","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0015537', 'cui_str': 'Faculties, Medical'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",,0.0438943,The decrease of area under the curve(insulin) was less and has a positive correlation with the changes in anthropometric measurements in PreProBG.,"[{'ForeName': 'Fulya', 'Initials': 'F', 'LastName': 'Calikoglu', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology and Metabolism, Istanbul Faculty of Medicine, University of Istanbul, Istanbul, Turkey. bfulyacalikoglu@gmail.com.'}, {'ForeName': 'Umut', 'Initials': 'U', 'LastName': 'Barbaros', 'Affiliation': 'Department of General Surgery, Istanbul Faculty of Medicine, University of Istanbul, Istanbul, Turkey.'}, {'ForeName': 'Ayse Kubat', 'Initials': 'AK', 'LastName': 'Uzum', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology and Metabolism, Istanbul Faculty of Medicine, University of Istanbul, Istanbul, Turkey.'}, {'ForeName': 'Yildiz', 'Initials': 'Y', 'LastName': 'Tutuncu', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology and Metabolism, Istanbul Faculty of Medicine, University of Istanbul, Istanbul, Turkey.'}, {'ForeName': 'Ilhan', 'Initials': 'I', 'LastName': 'Satman', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology and Metabolism, Istanbul Faculty of Medicine, University of Istanbul, Istanbul, Turkey.'}]",Obesity surgery,['10.1007/s11695-020-04894-6'] 1252,32810739,"The mitochondria-targeted antioxidant MitoQ, attenuates exercise-induced mitochondrial DNA damage.","High-intensity exercise damages mitochondrial DNA (mtDNA) in skeletal muscle. Whether MitoQ - a redox active mitochondrial targeted quinone - can reduce exercise-induced mtDNA damage is unknown. In a double-blind, randomized, placebo-controlled design, twenty-four healthy male participants consisting of two groups (placebo; n = 12, MitoQ; n = 12) performed an exercise trial of 4 x 4-min bouts at 90-95% of heart rate max. Participants completed an acute (20 mg MitoQ or placebo 1-h pre-exercise) and chronic (21 days of supplementation) phase. Blood and skeletal muscle were sampled immediately pre- and post-exercise and analysed for nuclear and mtDNA damage, lipid hydroperoxides, lipid soluble antioxidants, and the ascorbyl free radical. Exercise significantly increased nuclear and mtDNA damage across lymphocytes and muscle (P < 0.05), which was accompanied with changes in lipid hydroperoxides, ascorbyl free radical, and α-tocopherol (P < 0.05). Acute MitoQ treatment failed to impact any biomarker likely due to insufficient initial bioavailability. However, chronic MitoQ treatment attenuated nuclear (P < 0.05) and mtDNA damage in lymphocytes and muscle tissue (P < 0.05). Our work is the first to show a protective effect of chronic MitoQ supplementation on the mitochondrial and nuclear genomes in lymphocytes and human muscle tissue following exercise, which is important for genome stability.",2020,"However, chronic MitoQ treatment attenuated nuclear (P < 0.05) and mtDNA damage in lymphocytes and muscle tissue (P < 0.05).","['twenty-four healthy male participants consisting of two groups (placebo; n\xa0=\xa012, MitoQ; n\xa0=\xa012']","['High-intensity exercise damages mitochondrial DNA (mtDNA', 'MitoQ or placebo', 'placebo']","['Blood and skeletal muscle', 'lipid hydroperoxides, ascorbyl free radical, and α-tocopherol (P', 'nuclear and mtDNA damage across lymphocytes and muscle (P', 'mtDNA damage in lymphocytes and muscle tissue']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0012929', 'cui_str': 'Mitochondrial DNA'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0023776', 'cui_str': 'Fatty Acid Hydroperoxides'}, {'cui': 'C0016693', 'cui_str': 'Free radical'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0012929', 'cui_str': 'Mitochondrial DNA'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",24.0,0.192572,"However, chronic MitoQ treatment attenuated nuclear (P < 0.05) and mtDNA damage in lymphocytes and muscle tissue (P < 0.05).","[{'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Williamson', 'Affiliation': 'Ulster University, Sport and Exercise Research Institute, Newtownabbey, Northern Ireland, UK.'}, {'ForeName': 'Ciara M', 'Initials': 'CM', 'LastName': 'Hughes', 'Affiliation': 'Ulster University, Nursing and Health Research Institute, Newtownabbey, Northern Ireland, UK.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Cobley', 'Affiliation': 'Free Radical Research Group, University of the Highlands and Islands, Centre for Health Sciences, Inverness, IV2 3JH, UK.'}, {'ForeName': 'Gareth W', 'Initials': 'GW', 'LastName': 'Davison', 'Affiliation': 'Ulster University, Sport and Exercise Research Institute, Newtownabbey, Northern Ireland, UK. Electronic address: gw.davison@ulster.ac.uk.'}]",Redox biology,['10.1016/j.redox.2020.101673'] 1253,32819304,"The impact of high-intensity interval training exercise on breast cancer survivors: a pilot study to explore fitness, cardiac regulation and biomarkers of the stress systems.","BACKGROUND Cardiovascular disease (CVD) remains the largest cause of death in breast cancer survivors. The aim of this study was to explore the impact of exercise intensity on aerobic fitness and autonomic cardiac regulation (heart rate variability (HRV)) and salivary biomarkers of the stress systems (HPA-axis, cortisol; sympathetic nervous system, α-amylase) and mucosal immunity (secretory(s)-IgA), markers of increased risk of CVD in breast cancer survivors. METHODS Participants were randomly assigned to; 1) high intensity interval training (HIIT); 2) moderate-intensity, continuous aerobic training (CMIT); or 3) a wait-list control (CON) for a 12-week (36 session) stationary cycling intervention. Cardiorespiratory fitness (VO 2peak ), resting HRV and salivary biomarkers were measured at baseline 2-4 d pre-intervention and 2-4 d post the last exercise session. RESULTS Seventeen participants were included in this study (62 ± 8 years, HIIT; n = 6, CMIT; n = 5, CON; n = 6). A significant improvement (p ≤ 0.05) was observed for VO 2peak in the HIIT group; 19.3% (B = 3.98, 95%CI = [1.89; 4.02]) and a non-significant increase in the CMIT group; 5.6% (B = 1.96, 95%CI = [- 0.11; 4.03]), compared with a 2.6% (B = - 0.64, 95%CI = [- 2.10; 0.82]) decrease in the CON group. Post intervention improvements in HRV markers of vagal activity (log (ln)LF/HF, LnRMSSD) and sympathetic nervous system (α-amylase waking response) occurred for individuals exhibiting outlying (> 95% CI) levels at baseline compared to general population. CONCLUSION High intensity interval training improved cardiovascular fitness in breast cancer survivors and improved cardiac regulation, and sympathetic nervous system (stress) responses in some individuals. High-intensity interval training was safe and effective for breast cancer survivors to participate in with promising results as a time efficient intensity to improve physical health and stress, reducing CVD risk. TRIAL REGISTRATION This pilot study was retrospectively registered through the Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12620000684921 .",2020,"A significant improvement (p ≤ 0.05) was observed for VO 2peak in the HIIT group; 19.3% (B = 3.98, 95%CI = [1.89; 4.02]) and a non-significant increase in the CMIT group; 5.6% (B = 1.96, 95%CI = [- 0.11; 4.03]), compared with a 2.6% (B = - 0.64, 95%CI = [- 2.10; 0.82]) decrease in the CON group.","['Seventeen participants were included in this study (62\u2009±\u20098\u2009years, HIIT; n\u2009=\u20096, CMIT; n\u2009=\u20095, CON; n\u2009=\u20096', 'Participants were randomly assigned to; 1', 'breast cancer survivors', 'Australian New Zealand Clinical Trials Registry (ANZCTR']","['high intensity interval training (HIIT); 2) moderate-intensity, continuous aerobic training (CMIT); or 3) a wait-list control (CON', 'high-intensity interval training exercise', 'High-intensity interval training', 'High intensity interval training']","['VO 2peak', 'cardiovascular fitness', 'cardiac regulation, and sympathetic nervous system (stress) responses', 'Cardiorespiratory fitness (VO 2peak ), resting HRV and salivary biomarkers', 'physical health and stress, reducing CVD risk', 'aerobic fitness and autonomic cardiac regulation (heart rate variability (HRV)) and salivary biomarkers of the stress systems (HPA-axis, cortisol; sympathetic nervous system, α-amylase) and mucosal immunity (secretory(s)-IgA), markers of increased risk of CVD', 'HRV markers of vagal activity (log (ln)LF/HF, LnRMSSD) and sympathetic nervous system (α-amylase waking response']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0039044', 'cui_str': 'Sympathetic nervous system structure'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0085355', 'cui_str': 'Platelet-specific antigen'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0002712', 'cui_str': 'Amylases'}, {'cui': 'C0282558', 'cui_str': 'Mucosal Immunity'}, {'cui': 'C0020838', 'cui_str': 'Immunoglobulin A secretory'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",17.0,0.0895355,"A significant improvement (p ≤ 0.05) was observed for VO 2peak in the HIIT group; 19.3% (B = 3.98, 95%CI = [1.89; 4.02]) and a non-significant increase in the CMIT group; 5.6% (B = 1.96, 95%CI = [- 0.11; 4.03]), compared with a 2.6% (B = - 0.64, 95%CI = [- 2.10; 0.82]) decrease in the CON group.","[{'ForeName': 'Kellie', 'Initials': 'K', 'LastName': 'Toohey', 'Affiliation': 'Research Institute for Sport and Exercise, University of Canberra, Canberra, 2601, Australia. kellie.toohey@canberra.edu.au.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Pumpa', 'Affiliation': 'Research Institute for Sport and Exercise, University of Canberra, Canberra, 2601, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McKune', 'Affiliation': 'Research Institute for Sport and Exercise, University of Canberra, Canberra, 2601, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Cooke', 'Affiliation': 'Research Institute for Sport and Exercise, University of Canberra, Canberra, 2601, Australia.'}, {'ForeName': 'Marijke', 'Initials': 'M', 'LastName': 'Welvaert', 'Affiliation': 'Research Institute for Sport and Exercise, University of Canberra, Canberra, 2601, Australia.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Northey', 'Affiliation': 'Research Institute for Sport and Exercise, University of Canberra, Canberra, 2601, Australia.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Quinlan', 'Affiliation': 'Research Institute for Sport and Exercise, University of Canberra, Canberra, 2601, Australia.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Semple', 'Affiliation': 'Research Institute for Sport and Exercise, University of Canberra, Canberra, 2601, Australia.'}]",BMC cancer,['10.1186/s12885-020-07295-1'] 1254,32819305,Randomized double-blind clinical trial comparing safety and efficacy of the biosimilar BCD-022 with reference trastuzumab.,"BACKGROUND BCD-022 is a trastuzumab biosimilar which was shown to be equivalent to reference trastuzumab in a wide panel of physicochemical studies as well as preclinical studies in vitro and in vivo. International multicenter phase III clinical trial was conducted to comparatively assess efficacy and safety of BCD-022 and reference trastuzumab in combination with paclitaxel used as the therapy of metastatic HER2(+) breast cancer. Pharmacokinetics and immunogenicity were also studied. METHODS Patients with no previous treatment for metastatic HER2(+) breast cancer were randomly assigned 1:1 to BCD-022 or reference trastuzumab and were treated with trastuzumab + paclitaxel. Therapy continued for 6 cycles of therapy (every 3 weeks), until progression of the disease or unbearable toxicity. Primary study endpoint was overall response rate. Study goal was to prove equivalent efficacy of BCD-022 and reference trastuzumab. Equivalence margins for 95% CI for difference in overall response rates were set at [- 20%; 20%]. RESULTS In total 225 patients were enrolled into the study, 115 in BCD-022 arm and 110 in reference trastuzumab arm. Overall response rate was 49.6% in BCD-022 arm and 43.6% in reference trastuzumab arm. Limits of 95% CI for difference of overall response rates between arms were [(- 8.05)-19.89%], thus, they lied within predetermined equivalence margins [- 20%; 20%]. Profile of adverse events was similar between groups (any AEs were reported in 93.81% of patients in BCD-022 arm and 94.55% of patients in reference arm). No unexpected adverse reactions were reported throughout the study. No statistically significant differences regarding antibody occurrence rate (either BAb or NAb) was found between BCD-022 (n = 3; 2.65%) and comparator (n = 4; 3.64%). Both drug products are characterized with low occurrence rate and short life of anti-trastuzumab antibodies. Pharmacokinetics assessment after 1st and 6th study drug injection also demonstrated equivalent PK parameters by all outcome measures: AUC 0-504 , С mах , Т max , T 1/2 . Analysis of C trough did not reveal any significant inter-group differences as well. CONCLUSIONS Thus, results of this study have demonstrated therapeutic equivalence of trastuzumab biosimilar BCD-022 and referent trastuzumab drug. TRIAL REGISTRATION The trial was registered with ClinicalTrials.gov (Study Number NCT01764022 ). The date of registration was January 9, 2013.",2020,Profile of adverse events was similar between groups (any AEs were reported in 93.81% of patients in BCD-022 arm and 94.55% of patients in reference arm).,"['Patients with no previous treatment for metastatic HER2(+) breast cancer', 'metastatic HER2(+) breast cancer', 'In total 225 patients were enrolled into the study, 115 in BCD-022 arm and 110 in reference trastuzumab arm']","['BCD-022 and reference trastuzumab', 'paclitaxel', 'biosimilar BCD-022 with reference trastuzumab', 'trastuzumab + paclitaxel', 'BCD-022 or reference trastuzumab']","['equivalent PK parameters', 'overall response rates', 'overall response rate', 'adverse events', 'adverse reactions', 'antibody occurrence rate (either BAb or NAb', 'Pharmacokinetics and immunogenicity', 'Overall response rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0303407', 'cui_str': 'Indium-115'}, {'cui': 'C0053048', 'cui_str': 'BCD protocol'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0303401', 'cui_str': 'Indium-110'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}]","[{'cui': 'C0053048', 'cui_str': 'BCD protocol'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}]","[{'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",225.0,0.296749,Profile of adverse events was similar between groups (any AEs were reported in 93.81% of patients in BCD-022 arm and 94.55% of patients in reference arm).,"[{'ForeName': 'Sergey M', 'Initials': 'SM', 'LastName': 'Alexeev', 'Affiliation': 'N.N. Petrov NII of Oncology of the Ministry of Healthcare of the Russian Federation, Moscow, Russian Federation.'}, {'ForeName': 'Andrey V', 'Initials': 'AV', 'LastName': 'Khorinko', 'Affiliation': 'SBHI of PK Perm Krai, Perm Krai Cancer Dispensary, Perm, Russian Federation.'}, {'ForeName': 'Guzel Z', 'Initials': 'GZ', 'LastName': 'Mukhametshina', 'Affiliation': 'SAHI Republican Clinical Cancer Dispensary of the Ministry of Healthcare of the Republic of Tatarstan, Kazan, Russian Federation.'}, {'ForeName': 'Konstantin G', 'Initials': 'KG', 'LastName': 'Shelepen', 'Affiliation': 'Brest Regional Clinical Cancer Dispensary, Volgograd, Russian Federation.'}, {'ForeName': 'Olga N', 'Initials': 'ON', 'LastName': 'Burdaeva', 'Affiliation': 'SBHI of Arkhangelsk Region Arkhangelsk Regional Clinical Cancer Dispensary, Arkhangelsk, Russian Federation.'}, {'ForeName': 'Sergey A', 'Initials': 'SA', 'LastName': 'Kulik', 'Affiliation': 'KLPU City Cancer Dispensary of the City of Donetsk, Donetsk, DNR, Ukraine.'}, {'ForeName': 'Chiradoni Thugappa', 'Initials': 'CT', 'LastName': 'Satheesh', 'Affiliation': 'Sri Venkateshwara Hospital, Bangalore, India.'}, {'ForeName': 'Kirti', 'Initials': 'K', 'LastName': 'Srivastava', 'Affiliation': 'King Georges Medical University, Lucknow, India.'}, {'ForeName': 'Mummaneni', 'Initials': 'M', 'LastName': 'Vikranth', 'Affiliation': 'City Cancer Center, Vijayawada, India.'}, {'ForeName': 'Fedor', 'Initials': 'F', 'LastName': 'Kryukov', 'Affiliation': 'JSC BIOCAD, Saint Petersburg, Russian Federation. kryukov@biocad.ru.'}, {'ForeName': 'Anastasia N', 'Initials': 'AN', 'LastName': 'Paltusova', 'Affiliation': 'JSC BIOCAD, Saint Petersburg, Russian Federation.'}, {'ForeName': 'Mariya S', 'Initials': 'MS', 'LastName': 'Shustova', 'Affiliation': 'JSC BIOCAD, Saint Petersburg, Russian Federation.'}, {'ForeName': 'Roman A', 'Initials': 'RA', 'LastName': 'Ivanov', 'Affiliation': 'JSC BIOCAD, Saint Petersburg, Russian Federation.'}]",BMC cancer,['10.1186/s12885-020-07247-9'] 1255,32826319,Peptide Receptor Radionuclide Therapy of Late-Stage Neuroendocrine Tumor Patients with Multiple Cycles of 177 Lu-DOTA-EB-TATE.,"This study aimed to evaluate the safety and efficacy of multiple cycles of 177 Lu-DOTA-Evans blue (EB)-TATE peptide receptor radionuclide therapy (PRRT) at escalating doses in neuroendocrine tumors (NETs). Methods: Thirty-two NET patients were randomly divided into 3 groups and treated with escalating doses. Group A received 1.17 ± 0.09 GBq/cycle; group B, 1.89 ± 0.53 GBq/cycle; and group C, 3.97 ± 0.84 GBq/cycle. The treatment was planned for up to 3 cycles. Treatment-related adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Treatment response was evaluated according to the European Organisation for Research and Treatment of Cancer criteria and modified PERCIST. Results: Administration of PRRT was well tolerated, without life-threatening adverse events (CTCAE grade 4). CTCAE grade 3 hematotoxicity was recorded in 1 patient (16.6%) in group B (thrombocytopenia) and 3 patients (21.4%) in group C (thrombocytopenia in 3, anemia in 1). CTCAE grade 3 hepatotoxicity (elevated aspartate aminotransferase) was recorded in 1 patient in group A (8.3%) and 1 patient in group C (7.1%). No nephrotoxicity was observed. According to the criteria of the European Organisation for Research and Treatment of Cancer, the overall disease response rates were similar in groups A, B, and C (50.0%, 50.0%, and 42.9%, respectively), and the overall disease control rates were higher in groups B (83.3%) and C (71.5%) than in group A (66.7%). According to modified PERCIST, a lower disease response rate but a similar disease control rate were found. When a comparable baseline SUV max ranging from 15 to 40 was selected, the percentage change in SUV max increased slightly in group A (2.1% ± 40.8%) but decreased significantly in groups B and C (-38.7% ± 10.0% and -14.7% ± 20.0%, respectively) after the first PRRT ( P = 0.001) and decreased in all 3 groups after the third PRRT (groups A, B, and C: -6.9% ± 42.3%, -49.2% ± 30.9%, -11.9% ± 37.9%, respectively; P = 0.044). Conclusion: Dose escalations of up to 3.97 GBq/cycle seem to be well tolerated for 177 Lu-DOTA-EB-TATE. 177 Lu-DOTA-EB-TATE doses of 1.89 and 3.97 GBq/cycle were effective in tumor control and more effective than 1.17 GBq/cycle.",2021,"CTC-3 hematotoxicity was recorded in 1 patient (16.6%) in group B (thrombocytopenia) and 3 patients (21.4%) in group C (thrombocytopenia in 3, anemia in 1).","['A total of 32 NET patients', 'Late-stage Neuroendocrine Tumor Patients with Multiple Cycles of 177 Lu-DOTA-EB-TATE']","['multiple cycles of 177 Lu-DOTA-EB-TATE peptide receptor radionuclide therapy (PRRT', 'PRRT', 'Peptide Receptor Radionuclide Therapy']","['overall disease response rates (DRR', 'tolerated', 'overall disease control rates (DCR', 'nephrotoxicity', 'safety and efficacy', 'CTC-3 hepatotoxicity', 'CTC-3 hematotoxicity']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C0206754', 'cui_str': 'Neuroendocrine tumor'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C2959378', 'cui_str': 'Lutetium-177'}, {'cui': 'C0088359', 'cui_str': '1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C2959378', 'cui_str': 'Lutetium-177'}, {'cui': 'C0088359', 'cui_str': '1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid'}, {'cui': 'C0206473', 'cui_str': 'Peptide Receptor'}, {'cui': 'C0203608', 'cui_str': 'Radionuclide therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010931', 'cui_str': 'Dacryocystorhinostomy'}, {'cui': 'C0595916', 'cui_str': 'Toxic nephropathy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}, {'cui': 'C0920103', 'cui_str': 'Haematotoxicity'}]",32.0,0.0258005,"CTC-3 hematotoxicity was recorded in 1 patient (16.6%) in group B (thrombocytopenia) and 3 patients (21.4%) in group C (thrombocytopenia in 3, anemia in 1).","[{'ForeName': 'Qingxing', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Nuclear Medicine, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zang', 'Affiliation': 'Department of Nuclear Medicine, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Huimin', 'Initials': 'H', 'LastName': 'Sui', 'Affiliation': 'Department of Nuclear Medicine, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jiakun', 'Initials': 'J', 'LastName': 'Ren', 'Affiliation': 'Department of Nuclear Medicine, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': 'Department of Nuclear Medicine, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Nuclear Medicine, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Rongxi', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Nuclear Medicine, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Orit', 'Initials': 'O', 'LastName': 'Jacobson', 'Affiliation': 'Departments of Diagnostic Radiology, Chemical and Biomolecular Engineering, Biomedical Engineering, Yong Loo Lin School of Medicine and Faculty of Engineering, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Theranostics Center for Molecular Radiotherapy and Precision Oncology, Zentralklinik Bad Berka, Bad Berka, Germany; and.'}, {'ForeName': 'Yuejuan', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Division of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Department of Nuclear Medicine, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiaoyuan', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Departments of Diagnostic Radiology, Chemical and Biomolecular Engineering, Biomedical Engineering, Yong Loo Lin School of Medicine and Faculty of Engineering, National University of Singapore, Singapore, Singapore chen.shawn@nus.edu.sg.'}]","Journal of nuclear medicine : official publication, Society of Nuclear Medicine",['10.2967/jnumed.120.248658'] 1256,32798224,One-Year Decline of Poliovirus Antibodies Following Fractional-Dose Inactivated Poliovirus Vaccine.,"BACKGROUND Fractional dose (one-fifth of full intramuscular dose) of inactivated poliovirus vaccine (fIPV) administered intradermally is used as IPV dose-sparing strategy. We compared the rate of decline of poliovirus antibodies (PVA) in recipients of 2 doses of fIPV or IPV. METHODS A community-based randomized controlled trial was conducted in Karachi, Pakistan. Children aged 14 weeks were randomized into fIPV or full IPV (study arms A, B) and received 1 vaccine dose at age 14 weeks and 1 at age 9 months. PVAs were measured at age 14, 18 weeks and 10, 21 months. RESULTS Seroprevalence of poliovirus type 2 antibodies in 170/250 (68%) children after 2 IPV or fIPV doses at age 10 months in A and B reached 100% vs 99% (P = .339), and at 21 months, 86% vs 67% (P = .004). Between age 10 and 21 months antibody log2 titers dropped from ≥ 10.5 to 6.8 in A and from 9.2 to 3.7 in B. CONCLUSIONS There was a significant decline in antibody titers 12 months following the second IPV dose. The slope of decline was similar for full IPV and fIPV recipients. The results provide further evidence that fIPV is a viable option for IPV dose-sparing. CLINICAL TRIALS REGISTRATION NCT03286803.",2021,"Between 10 and 21 months of age, the antibody-titers in log2 scale dropped from >=10.5 to 6.8 in arm-A; and from 9.2 to 3.7 in arm B. INTERPRETATION A significant decline in antibody titers12 months following second IPV dose.","['Community-based randomized controlled trial was conducted in Karachi, Pakistan', 'recipients of either two doses of fIPV or IPV', 'Children aged 14 weeks']","['inactivated poliovirus-vaccine administered intradermally (fIPV', 'fractional-dose inactivated poliovirus vaccine']","['antibody-titers in log2 scale', 'poliovirus antibodies', 'PVA', 'rate of decline of poliovirus antibodies (PVA']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0085305', 'cui_str': 'Feline infectious peritonitis virus'}, {'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0036106', 'cui_str': 'Salk Vaccine'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0085305', 'cui_str': 'Feline infectious peritonitis virus'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0206435', 'cui_str': 'Human poliovirus'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]",,0.169346,"Between 10 and 21 months of age, the antibody-titers in log2 scale dropped from >=10.5 to 6.8 in arm-A; and from 9.2 to 3.7 in arm B. INTERPRETATION A significant decline in antibody titers12 months following second IPV dose.","[{'ForeName': 'Ali Faisal', 'Initials': 'AF', 'LastName': 'Saleem', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Ondrej', 'Initials': 'O', 'LastName': 'Mach', 'Affiliation': 'Polio Eradication Department, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Mohammad Tahir', 'Initials': 'MT', 'LastName': 'Yousafzai', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Zaubina', 'Initials': 'Z', 'LastName': 'Kazi', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Attaullah', 'Initials': 'A', 'LastName': 'Baig', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Sajid', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Vishali', 'Initials': 'V', 'LastName': 'Jeyaseelan', 'Affiliation': 'Polio Eradication Department, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Roland W', 'Initials': 'RW', 'LastName': 'Sutter', 'Affiliation': 'Polio Eradication Department, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Anita K M', 'Initials': 'AKM', 'LastName': 'Zaidi', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa504'] 1257,32798283,Improvement of Severe Fatigue Following Nuclease Therapy in Patients With Primary Sjögren's Syndrome: A Randomized Clinical Trial.,"OBJECTIVE To assess the safety and efficacy of RSLV-132, an RNase Fc fusion protein, in a phase II randomized, double-blind, placebo-controlled clinical trial in patients with primary Sjögren's syndrome (SS). METHODS Thirty patients with primary SS were randomized to receive treatment with RSLV-132 or placebo intravenously once per week for 2 weeks, and then every 2 weeks for 12 weeks. Eight patients received placebo and 20 patients received RSLV-132 at a dose of 10 mg/kg. Clinical efficacy measures included the European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index, EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Profile of Fatigue (ProF), and the Digit Symbol Substitution Test (DSST). RESULTS Patients randomized to receive RSLV-132 experienced clinically meaningful improvements in the ESSPRI score (P = 0.27), FACIT-F score (P = 0.05), ProF score (P = 0.07), and DSST (P = 0.02) from baseline to day 99, whereas patients who received placebo showed no changes in any of these clinical efficacy measures. This improvement was significantly correlated with increased expression of selected interferon-inducible genes (Pearson's correlations, each P < 0.05). CONCLUSION Administration of RSLV-132 improved severe fatigue, as determined by 4 independent patient-reported measures of fatigue, in patients with primary SS.",2021,"RESULTS Patients randomized to RSLV-132, but not placebo, experienced clinically meaningful improvements in ESSPRI, FACIT-F, ProF, and DSST.","[""Primary Sjögren's Syndrome"", ""patients with primary Sjögren's syndrome (pSS"", 'Thirty patients']","['Nuclease Therapy', 'RSLV-132', 'intravenous RSLV-132 or placebo', 'placebo']","['ESSPRI, FACIT-F, ProF, and DSST', 'expression of selected interferon-inducible genes', 'severe fatigue', ""Sjögren's syndrome disease activity index (ESSDAI), EULAR Sjögren's syndrome patient reported index (ESSPRI), FACIT fatigue (FACIT-F), and profile of fatigue (ProF), and the digit symbol substitution test (DSST"", 'Severe Fatigue', 'European League Against Rheumatism (EULAR']","[{'cui': 'C0151449', 'cui_str': ""Primary Sjögren's syndrome""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0597094', 'cui_str': 'Nuclease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4705323', 'cui_str': 'RSLV-132'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1527336', 'cui_str': ""Sjögren's syndrome""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0009326', 'cui_str': 'Collagen disease'}]",30.0,0.53509,"RESULTS Patients randomized to RSLV-132, but not placebo, experienced clinically meaningful improvements in ESSPRI, FACIT-F, ProF, and DSST.","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Posada', 'Affiliation': 'Resolve Therapeutics, St. Petersburg, Florida.'}, {'ForeName': 'Saba', 'Initials': 'S', 'LastName': 'Valadkhan', 'Affiliation': 'Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Burge', 'Affiliation': 'Resolve Therapeutics, St. Petersburg, Florida.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Davies', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Tarn', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Casement', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Jobling', 'Affiliation': 'Newcastle Biomedical Research Centre and Newcastle upon Tyne Hospital NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gallagher', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Wilson', 'Affiliation': 'Q2 Solutions, Morrisville, North Carolina.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Barone', 'Affiliation': 'University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Fisher', 'Affiliation': 'NIHR Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust, and University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Wan-Fai', 'Initials': 'WF', 'LastName': 'Ng', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, UK.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41489'] 1258,32804911,Factors Associated With Nonadherence in an Emergency Department-based Multicenter Randomized Clinical Trial of a Probiotic in Children With Acute Gastroenteritis.,"ABSTRACT Nonadherence in clinical trials affects safety and efficacy determinations. Predictors of nonadherence in pediatric acute illness trials are unknown. We sought to examine predictors of nonadherence in a multicenter randomized trial of 971 children with acute gastroenteritis receiving a 5-day oral course of Lactobacillus rhamnosus GG or placebo. Adherence, defined as consuming all doses of the product, was reported by the parents and recorded during daily follow-up contacts. Of 943 patients with follow-up data, 766 (81.2%) were adherent. On multivariate analysis, older age (OR 1.19; 95% CI: 1.00-1.43), increased vomiting duration (OR 1.23; 95% CI: 1.05-1.45), higher dehydration score (OR 1.23, 95% CI: 1.07-1.42), and hospitalization following ED discharge (OR 4.16, 95% CI: 1.21--14.30) were factors associated with nonadherence; however, those with highest severity scores were more likely to adhere (OR 0.87, 95% CI: 0.80-0.95). These data may inform strategies and specific targets to maximize adherence in future pediatric trials.",2021,"On multivariate analysis older age (OR 1.19; 95%CI: 1.00-1.43), increased vomiting duration (OR 1.23; 95% CI: 1.05-1.45), higher dehydration score (OR 1.23, 95% CI: 1.07-1.42) and hospitalization following ED discharge (OR 4.16, 95% CI: 1.21, 14.30) were factors associated with non-adherence; however those with highest severity scores were more likely to adhere (OR 0.87, 95% CI: 0.80-0.95).","['Children with Acute Gastroenteritis', '971 children with acute gastroenteritis receiving a 5-day oral course of', '943 patients with follow-up data, 766 (81.2%) where adherent']","['Probiotic', 'Lactobacillus rhamnosus GG or placebo']","['vomiting duration', 'hospitalization following ED discharge', 'higher dehydration score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0267446', 'cui_str': 'Acute gastroenteritis'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",971.0,0.225454,"On multivariate analysis older age (OR 1.19; 95%CI: 1.00-1.43), increased vomiting duration (OR 1.23; 95% CI: 1.05-1.45), higher dehydration score (OR 1.23, 95% CI: 1.07-1.42) and hospitalization following ED discharge (OR 4.16, 95% CI: 1.21, 14.30) were factors associated with non-adherence; however those with highest severity scores were more likely to adhere (OR 0.87, 95% CI: 0.80-0.95).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schnadower', 'Affiliation': ""Division of Emergency Medicine, Cincinnati Children's Hospital Medical Center and Department of Pediatrics University of Cincinnati College of Medicine, Cincinnati OH.""}, {'ForeName': 'Cindy G', 'Initials': 'CG', 'LastName': 'Roskind', 'Affiliation': 'Department of Emergency Medicine, Columbia University College of Physicians & Surgeons, New York, NY.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'VanBuren', 'Affiliation': 'Department of Pediatrics, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Powell', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Ann & Robert H. Lurie Children's Hospital, Northwestern University Feinberg School of Medicine, Chicago, IL.""}, {'ForeName': 'Jesse G', 'Initials': 'JG', 'LastName': 'Norris', 'Affiliation': 'Department of Pediatrics, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Phillip I', 'Initials': 'PI', 'LastName': 'Tarr', 'Affiliation': 'Division of Gastroenterology, Hepatology, & Nutrition, Department of Pediatrics, Washington University in St. Louis School of Medicine, St. Louis, MO.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Sapien', 'Affiliation': 'Department of Emergency Medicine, University of New Mexico, Albuquerque, NM.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': ""O'Connell"", 'Affiliation': ""Division of Emergency Medicine, Children's National Health System, Department of Pediatrics, The George Washington School of Medicine and Health Sciences, Washington, DC.""}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Chun', 'Affiliation': ""Department of Emergency Medicine, Rhode Island Hospital/Hasbro Children's Hospital and Brown University, Providence, RI.""}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Rogers', 'Affiliation': 'Departments of Emergency Medicine and Pediatrics, University of Michigan, Ann Arbor.'}, {'ForeName': 'Seema R', 'Initials': 'SR', 'LastName': 'Bhatt', 'Affiliation': ""Division of Emergency Medicine, Cincinnati Children's Hospital Medical Center and Department of Pediatrics University of Cincinnati College of Medicine, Cincinnati OH.""}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Mahajan', 'Affiliation': 'Departments of Emergency Medicine and Pediatrics, University of Michigan, Ann Arbor.'}, {'ForeName': 'Marc H', 'Initials': 'MH', 'LastName': 'Gorelick', 'Affiliation': ""Central Administration, Children's Minnesota, Minneapolis MN.""}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Vance', 'Affiliation': 'Departments of Emergency Medicine and Pediatrics, University of California, Davis, School of Medicine, Sacramento, CA.'}, {'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Dean', 'Affiliation': 'Department of Pediatrics, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Freedman', 'Affiliation': ""Sections of Pediatric Emergency Medicine and Gastroenterology, Department of Pediatrics, Alberta Children's Hospital, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002904'] 1259,32820619,"Phase 1 Studies to Define the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Profiles of the Nonsteroidal Mineralocorticoid Receptor Antagonist Apararenone in Healthy Volunteers.","Apararenone is a long-acting, nonsteroidal mineralocorticoid receptor antagonist (MRA). The safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) profiles of single- and multiple-dose apararenone were assessed in 3 phase 1 randomized, double-blind studies in 223 healthy adults. Study 1 assessed the PK, safety/tolerability, and PD of single-dose apararenone (3.75-640 mg) and multiple-dose apararenone (10-40 mg/day on days 1-14, 320 mg loading dose on day 1 + 10 mg/day on days 2-14, or 40-320 mg loading dose on day 1 + 2.5-20 mg/day on days 2-14) in Caucasian and Black men and women. Study 2 assessed the PK and safety of single-dose apararenone (5-320 mg) in healthy Japanese men. Study 3 assessed the PK, PD, and safety/tolerability of single-dose apararenone (160 or 640 mg) or eplerenone (200 mg; only for 160 mg of apararenone), each after fludrocortisone challenge in Caucasian men. In studies 1 and 2, an approximately dose-proportional increase was observed in PK parameters over the apararenone dose range of 3.75-40 mg; at higher doses, a less than dose-proportional increase was observed. Food, sex, age, and race had no apparent effect on apararenone PK. A long half-life was seen for apararenone and its principal metabolite; in addition, the exposure of the metabolite was lower than that of apararenone. Apararenone suppressed the decrease in urinary sodium and potassium ion ratio that occurs after loading with fludrocortisone. These studies support the mechanism of action of apararenone as an MRA, and further clinical development is warranted.",2021,Apararenone suppressed the decrease in urinary sodium and potassium ion ratio that occurs after loading with fludrocortisone.,"['Caucasian men', '223 healthy adults', 'Caucasian and Black men and women', 'healthy Japanese men', 'Healthy Volunteers']","['eplerenone (200 mg; only for 160 mg of apararenone', 'Apararenone', 'Nonsteroidal Mineralocorticoid Receptor Antagonist Apararenone', 'apararenone']","['safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) profiles of single- and multiple-dose apararenone', 'PK, PD, and safety/tolerability', 'urinary sodium and potassium ion ratio', 'Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Profiles', 'PK parameters', 'PK, safety/tolerability, and PD']","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0961485', 'cui_str': 'eplerenone'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0597277', 'cui_str': 'Potassium Ion'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",223.0,0.0528627,Apararenone suppressed the decrease in urinary sodium and potassium ion ratio that occurs after loading with fludrocortisone.,"[{'ForeName': 'Tadakatsu', 'Initials': 'T', 'LastName': 'Nakamura', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.'}, {'ForeName': 'Atsuhiro', 'Initials': 'A', 'LastName': 'Kawaguchi', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.855'] 1260,32838678,Technology-Assisted Teachers' Training to Promote Socioemotional Well-Being of Children in Public Schools in Rural Pakistan.,"BACKGROUND The World Health Organization's (WHO) Eastern Mediterranean Regional Office (EMRO) developed a school mental health program (SMHP) to help reduce the burden of youth mental health problems. Designed in collaboration with international consultants, the SMHP draws on evidence-based interventions to train personnel to identify students in need, respond therapeutically, and engage families in seeking care. METHODS Teams from Pakistan, Egypt, Iran, and Jordan collaborated with the WHO EMRO and British and U.S. universities to form the School Health Implementation Network: Eastern Mediterranean Region (SHINE), a National Institute of Mental Health-funded global mental health hub. SHINE partners used a ""theory of change"" process to adapt the SMHP to be more readily adopted by school personnel and replicated with fidelity. The adapted SMHP more directly addresses teachers' priorities and uses technology to facilitate training. RESULTS A cluster-randomized implementation effectiveness trial enrolling 960 children ages 8-13 in 80 Pakistani schools will test the adapted SMHP against the original. Children who screen positive on first the teacher and subsequently the parent Strengths and Difficulties Questionnaires (SDQs) will be enrolled and tracked for 9 months. The primary trial outcome is reduction in parent-rated SDQ total difficulties scores. Secondary outcomes include children's well-being, academic performance, absenteeism, and perceived stigma; parent-teacher interaction; teachers' self-efficacy and subjective well-being; and school environment. Implementation outcomes include change in teachers' behavior and sense of program acceptability, cultural appropriateness, feasibility, penetration, and sustainability. NEXT STEPS The trial began in October 2019, and the expected completion date is March 2021. Outcomes will inform dissemination of the SMHP in Pakistan and elsewhere.",2021,"Implementation outcomes include change in teachers' behavior and sense of program acceptability, cultural appropriateness, feasibility, penetration, and sustainability. ","['960 children ages 8-13 in 80 Pakistani schools will test the adapted SMHP against the original', 'Teams from Pakistan, Egypt, Iran, and Jordan collaborated with the WHO EMRO and British and U.S. universities to form the School Health Implementation Network: Eastern Mediterranean Region (SHINE), a National Institute of Mental Health-funded global mental health hub', 'Children in Public Schools in Rural Pakistan']","[""Technology-Assisted Teachers' Training"", 'school mental health program (SMHP']","[""teachers' behavior and sense of program acceptability, cultural appropriateness, feasibility, penetration, and sustainability"", 'reduction in parent-rated SDQ total difficulties scores', 'parent Strengths and Difficulties Questionnaires (SDQs', ""children's well-being, academic performance, absenteeism, and perceived stigma; parent-teacher interaction; teachers' self-efficacy and subjective well-being; and school environment""]","[{'cui': 'C4517908', 'cui_str': '960'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0240620', 'cui_str': 'Pakistani'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0022418', 'cui_str': 'Jordan'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0036372', 'cui_str': 'Nursing, School'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0282645', 'cui_str': 'Mediterranean Region'}, {'cui': 'C0027466', 'cui_str': 'National Institute of Mental Health'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0557800', 'cui_str': 'Public school'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}, {'cui': 'C0008093', 'cui_str': 'Child Well Being'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]",960.0,0.0687099,"Implementation outcomes include change in teachers' behavior and sense of program acceptability, cultural appropriateness, feasibility, penetration, and sustainability. ","[{'ForeName': 'Syed Usman', 'Initials': 'SU', 'LastName': 'Hamdani', 'Affiliation': ""Department of Primary Care and\xa0Mental Health, University of Liverpool, Liverpool, United Kingdom (Hamdani, Huma, Rahman); Institute of Psychiatry, World Health Organization Collaborating Centre for Mental Health Research and Training, Rawalpindi, Pakistan (Hamdani, Minhas, Nizami); Human Development Research Foundation, Islamabad, Pakistan (Hamdani, Huma, Warraitch, Suleman, Muzzafar, Sikander); National Institute of Mental Health, Bethesda, Maryland (Pringle); Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston (Hamoda); Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom (Wang); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Wissow).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ""Department of Primary Care and\xa0Mental Health, University of Liverpool, Liverpool, United Kingdom (Hamdani, Huma, Rahman); Institute of Psychiatry, World Health Organization Collaborating Centre for Mental Health Research and Training, Rawalpindi, Pakistan (Hamdani, Minhas, Nizami); Human Development Research Foundation, Islamabad, Pakistan (Hamdani, Huma, Warraitch, Suleman, Muzzafar, Sikander); National Institute of Mental Health, Bethesda, Maryland (Pringle); Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston (Hamoda); Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom (Wang); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Wissow).""}, {'ForeName': 'Azza', 'Initials': 'A', 'LastName': 'Warraitch', 'Affiliation': ""Department of Primary Care and\xa0Mental Health, University of Liverpool, Liverpool, United Kingdom (Hamdani, Huma, Rahman); Institute of Psychiatry, World Health Organization Collaborating Centre for Mental Health Research and Training, Rawalpindi, Pakistan (Hamdani, Minhas, Nizami); Human Development Research Foundation, Islamabad, Pakistan (Hamdani, Huma, Warraitch, Suleman, Muzzafar, Sikander); National Institute of Mental Health, Bethesda, Maryland (Pringle); Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston (Hamoda); Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom (Wang); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Wissow).""}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Suleman', 'Affiliation': ""Department of Primary Care and\xa0Mental Health, University of Liverpool, Liverpool, United Kingdom (Hamdani, Huma, Rahman); Institute of Psychiatry, World Health Organization Collaborating Centre for Mental Health Research and Training, Rawalpindi, Pakistan (Hamdani, Minhas, Nizami); Human Development Research Foundation, Islamabad, Pakistan (Hamdani, Huma, Warraitch, Suleman, Muzzafar, Sikander); National Institute of Mental Health, Bethesda, Maryland (Pringle); Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston (Hamoda); Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom (Wang); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Wissow).""}, {'ForeName': 'Naila', 'Initials': 'N', 'LastName': 'Muzzafar', 'Affiliation': ""Department of Primary Care and\xa0Mental Health, University of Liverpool, Liverpool, United Kingdom (Hamdani, Huma, Rahman); Institute of Psychiatry, World Health Organization Collaborating Centre for Mental Health Research and Training, Rawalpindi, Pakistan (Hamdani, Minhas, Nizami); Human Development Research Foundation, Islamabad, Pakistan (Hamdani, Huma, Warraitch, Suleman, Muzzafar, Sikander); National Institute of Mental Health, Bethesda, Maryland (Pringle); Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston (Hamoda); Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom (Wang); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Wissow).""}, {'ForeName': 'Fareed Aslam', 'Initials': 'FA', 'LastName': 'Minhas', 'Affiliation': ""Department of Primary Care and\xa0Mental Health, University of Liverpool, Liverpool, United Kingdom (Hamdani, Huma, Rahman); Institute of Psychiatry, World Health Organization Collaborating Centre for Mental Health Research and Training, Rawalpindi, Pakistan (Hamdani, Minhas, Nizami); Human Development Research Foundation, Islamabad, Pakistan (Hamdani, Huma, Warraitch, Suleman, Muzzafar, Sikander); National Institute of Mental Health, Bethesda, Maryland (Pringle); Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston (Hamoda); Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom (Wang); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Wissow).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ""Department of Primary Care and\xa0Mental Health, University of Liverpool, Liverpool, United Kingdom (Hamdani, Huma, Rahman); Institute of Psychiatry, World Health Organization Collaborating Centre for Mental Health Research and Training, Rawalpindi, Pakistan (Hamdani, Minhas, Nizami); Human Development Research Foundation, Islamabad, Pakistan (Hamdani, Huma, Warraitch, Suleman, Muzzafar, Sikander); National Institute of Mental Health, Bethesda, Maryland (Pringle); Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston (Hamoda); Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom (Wang); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Wissow).""}, {'ForeName': 'Asad Tameezuddin', 'Initials': 'AT', 'LastName': 'Nizami', 'Affiliation': ""Department of Primary Care and\xa0Mental Health, University of Liverpool, Liverpool, United Kingdom (Hamdani, Huma, Rahman); Institute of Psychiatry, World Health Organization Collaborating Centre for Mental Health Research and Training, Rawalpindi, Pakistan (Hamdani, Minhas, Nizami); Human Development Research Foundation, Islamabad, Pakistan (Hamdani, Huma, Warraitch, Suleman, Muzzafar, Sikander); National Institute of Mental Health, Bethesda, Maryland (Pringle); Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston (Hamoda); Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom (Wang); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Wissow).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ""Department of Primary Care and\xa0Mental Health, University of Liverpool, Liverpool, United Kingdom (Hamdani, Huma, Rahman); Institute of Psychiatry, World Health Organization Collaborating Centre for Mental Health Research and Training, Rawalpindi, Pakistan (Hamdani, Minhas, Nizami); Human Development Research Foundation, Islamabad, Pakistan (Hamdani, Huma, Warraitch, Suleman, Muzzafar, Sikander); National Institute of Mental Health, Bethesda, Maryland (Pringle); Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston (Hamoda); Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom (Wang); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Wissow).""}, {'ForeName': 'Siham', 'Initials': 'S', 'LastName': 'Sikander', 'Affiliation': ""Department of Primary Care and\xa0Mental Health, University of Liverpool, Liverpool, United Kingdom (Hamdani, Huma, Rahman); Institute of Psychiatry, World Health Organization Collaborating Centre for Mental Health Research and Training, Rawalpindi, Pakistan (Hamdani, Minhas, Nizami); Human Development Research Foundation, Islamabad, Pakistan (Hamdani, Huma, Warraitch, Suleman, Muzzafar, Sikander); National Institute of Mental Health, Bethesda, Maryland (Pringle); Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston (Hamoda); Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom (Wang); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Wissow).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ""Department of Primary Care and\xa0Mental Health, University of Liverpool, Liverpool, United Kingdom (Hamdani, Huma, Rahman); Institute of Psychiatry, World Health Organization Collaborating Centre for Mental Health Research and Training, Rawalpindi, Pakistan (Hamdani, Minhas, Nizami); Human Development Research Foundation, Islamabad, Pakistan (Hamdani, Huma, Warraitch, Suleman, Muzzafar, Sikander); National Institute of Mental Health, Bethesda, Maryland (Pringle); Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston (Hamoda); Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom (Wang); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Wissow).""}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Pringle', 'Affiliation': ""Department of Primary Care and\xa0Mental Health, University of Liverpool, Liverpool, United Kingdom (Hamdani, Huma, Rahman); Institute of Psychiatry, World Health Organization Collaborating Centre for Mental Health Research and Training, Rawalpindi, Pakistan (Hamdani, Minhas, Nizami); Human Development Research Foundation, Islamabad, Pakistan (Hamdani, Huma, Warraitch, Suleman, Muzzafar, Sikander); National Institute of Mental Health, Bethesda, Maryland (Pringle); Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston (Hamoda); Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom (Wang); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Wissow).""}, {'ForeName': 'Hesham M', 'Initials': 'HM', 'LastName': 'Hamoda', 'Affiliation': ""Department of Primary Care and\xa0Mental Health, University of Liverpool, Liverpool, United Kingdom (Hamdani, Huma, Rahman); Institute of Psychiatry, World Health Organization Collaborating Centre for Mental Health Research and Training, Rawalpindi, Pakistan (Hamdani, Minhas, Nizami); Human Development Research Foundation, Islamabad, Pakistan (Hamdani, Huma, Warraitch, Suleman, Muzzafar, Sikander); National Institute of Mental Health, Bethesda, Maryland (Pringle); Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston (Hamoda); Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom (Wang); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Wissow).""}, {'ForeName': 'Duolao', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': ""Department of Primary Care and\xa0Mental Health, University of Liverpool, Liverpool, United Kingdom (Hamdani, Huma, Rahman); Institute of Psychiatry, World Health Organization Collaborating Centre for Mental Health Research and Training, Rawalpindi, Pakistan (Hamdani, Minhas, Nizami); Human Development Research Foundation, Islamabad, Pakistan (Hamdani, Huma, Warraitch, Suleman, Muzzafar, Sikander); National Institute of Mental Health, Bethesda, Maryland (Pringle); Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston (Hamoda); Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom (Wang); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Wissow).""}, {'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': ""Department of Primary Care and\xa0Mental Health, University of Liverpool, Liverpool, United Kingdom (Hamdani, Huma, Rahman); Institute of Psychiatry, World Health Organization Collaborating Centre for Mental Health Research and Training, Rawalpindi, Pakistan (Hamdani, Minhas, Nizami); Human Development Research Foundation, Islamabad, Pakistan (Hamdani, Huma, Warraitch, Suleman, Muzzafar, Sikander); National Institute of Mental Health, Bethesda, Maryland (Pringle); Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston (Hamoda); Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom (Wang); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Wissow).""}, {'ForeName': 'Lawrence S', 'Initials': 'LS', 'LastName': 'Wissow', 'Affiliation': ""Department of Primary Care and\xa0Mental Health, University of Liverpool, Liverpool, United Kingdom (Hamdani, Huma, Rahman); Institute of Psychiatry, World Health Organization Collaborating Centre for Mental Health Research and Training, Rawalpindi, Pakistan (Hamdani, Minhas, Nizami); Human Development Research Foundation, Islamabad, Pakistan (Hamdani, Huma, Warraitch, Suleman, Muzzafar, Sikander); National Institute of Mental Health, Bethesda, Maryland (Pringle); Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston (Hamoda); Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom (Wang); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Wissow).""}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.202000005'] 1261,32814508,Comparing the Effects of Reading Intervention Versus Reading and Mindset Intervention for Upper Elementary Students With Reading Difficulties.,"The primary purpose of this study was to examine the effects of providing mindset intervention in addition to reading intervention compared with only reading intervention for fourth graders with reading difficulties. Reading intervention was provided daily in 45 min sessions throughout the school year. Mindset intervention occurred in small groups for 24-30 min lessons. Multilevel structural equation modeling (SEM) via n- level SEM was used to account for the latent variable representation of constructs, and the complex nesting and cross-classification structure of the data. Students in the reading intervention plus mindset condition significantly outperformed the business as usual condition on nonword reading ( d = 0.35) as did students in the reading intervention condition ( d = 0.20), who also outperformed the business as usual condition on phonological processing ( d = 0.28). There were no significant differences among students in the three conditions on nonword reading, word reading, phonological processing, reading comprehension, or growth mindset. Initial reading achievement, mindset, and problem behavior did not generally moderate these findings.",2021,"There were no significant differences among students in the three conditions on nonword reading, word reading, phonological processing, reading comprehension, or growth mindset.","['Upper Elementary Students With Reading Difficulties', 'fourth graders with reading difficulties']","['Multilevel structural equation modeling (SEM) via n', 'Reading Intervention Versus Reading and Mindset Intervention', 'mindset intervention']","['nonword reading, word reading, phonological processing, reading comprehension, or growth mindset', 'Initial reading achievement, mindset, and problem behavior']","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0586742', 'cui_str': 'Difficulty reading'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}]","[{'cui': 'C0681947', 'cui_str': 'Structural Equation Modeling'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}]",,0.0204287,"There were no significant differences among students in the three conditions on nonword reading, word reading, phonological processing, reading comprehension, or growth mindset.","[{'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Wanzek', 'Affiliation': 'Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Stephanie Al', 'Initials': 'SA', 'LastName': 'Otaiba', 'Affiliation': 'Southern Methodist University, Dallas, TX, USA.'}, {'ForeName': 'Yaacov', 'Initials': 'Y', 'LastName': 'Petscher', 'Affiliation': 'Florida State University, Tallahassee, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Lemons', 'Affiliation': 'Stanford University, CA, USA.'}, {'ForeName': 'Samantha A', 'Initials': 'SA', 'LastName': 'Gesel', 'Affiliation': 'University of North Carolina at Charlotte, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Fluhler', 'Affiliation': 'Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Donegan', 'Affiliation': 'Northern Illinois University, Nashville, TN, USA.'}, {'ForeName': 'Brenna K', 'Initials': 'BK', 'LastName': 'Rivas', 'Affiliation': 'Southern Methodist University, Dallas, TX, USA.'}]",Journal of learning disabilities,['10.1177/0022219420949281'] 1262,32820698,"Efficacy and safety of sodium RISedronate for glucocorticoid-induced OsTeoporosis with rheumaTOid arthritis (RISOTTO study): A multicentre, double-blind, randomized, placebo-controlled trial.","OBJECTIVE No evidence has shown the efficacy of Sodium Risedronate (Risedronate) for glucocorticoid-induced osteoporosis (GIO) in patients with Rheumatoid arthritis (RA). The aim of this study was to explore the effectiveness and safety of Risedronate for GIO complicated with RA. METHODS This was a six-month randomized, double-blind, placebo-controlled trial of 95 patients with GIO complicated with RA from 19 centers. The primary endpoint was the change from baseline in lumbar spine bone mineral density (L-BMD). Secondary endpoints included changes in femoral neck and total hip BMD and bone turnover markers, as well as rheumatoid arthritis Disease Activity Score with 28-joint counts. Incident of non-traumatic spine fractures and adverse events were tracked as safety endpoints. RESULTS Increase in L-BMD was significantly greater in the Risedronate group compared to the Placebo group (Risedronate: 3.49% [95% CI: 1.92-5.05] vs Placebo: 0.12% [95% CI: -2.07 to 2.30], p  < .0001). No significant difference was found in the femoral neck and total hip BMD. Although adverse events were observed in 28 patients, none were considered serious. Non-traumatic vertebral fractures were identified in 10 patients. CONCLUSION Risedronate was effective in increasing L-BMD and was well tolerated in patients with GIO complicated with RA.",2021,"Although adverse events were observed in 28 patients, none were considered serious. Non-traumatic vertebral fractures were identified in 10 patients.","['95 patients with GIO complicated with RA from 19 centers', 'patients with Rheumatoid arthritis (RA', 'patients with GIO complicated with RA']","['Placebo', 'Risedronate', 'Sodium Risedronate (Risedronate', 'sodium RISedronate', 'placebo']","['changes in femoral neck and total hip BMD and bone turnover markers, as well as rheumatoid arthritis Disease Activity Score with 28-joint counts', 'lumbar spine bone mineral density (L-BMD', 'femoral neck and total hip BMD', 'Efficacy and safety', 'effectiveness and safety', 'adverse events', 'L-BMD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0246719', 'cui_str': 'Risedronate'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C2732410', 'cui_str': 'Disease activity score in rheumatoid arthritis'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",95.0,0.580505,"Although adverse events were observed in 28 patients, none were considered serious. Non-traumatic vertebral fractures were identified in 10 patients.","[{'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Fujieda', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Graduate School of Medicine and Faculty of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Horita', 'Affiliation': 'Internal Medicine, Tomakomai City Hospital, Tomakomai, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Nishimoto', 'Affiliation': 'Department of Biostatistics, Clinical Research and Medical Innovation Center, Hokkaido University Hospital, Sapporo, Japan.'}, {'ForeName': 'Kazuhide', 'Initials': 'K', 'LastName': 'Tanimura', 'Affiliation': 'Hokkaido Medical Center for Rheumatic Diseases, Sapporo, Japan.'}, {'ForeName': 'Yoshiharu', 'Initials': 'Y', 'LastName': 'Amasaki', 'Affiliation': 'Department of Rheumatology, Tonan Hospital, Sapporo, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Kasahara', 'Affiliation': 'Department of Rheumatology, NTT Sapporo Medical Center, Sapporo, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Furukawa', 'Affiliation': 'Internal Medicine, Kushiro Red Cross Hospital, Kushiro, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Takeda', 'Affiliation': 'Internal Medicine, Hokkaido Spinal Cord Injury Center, Bibai, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Fukaya', 'Affiliation': '3rd Department of Internal Medicine, Obihiro Kosei Hospital, Obihiro, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Matsui', 'Affiliation': 'Internal Medicine, Takikawa City Hospital, Takikawa, Japan.'}, {'ForeName': 'Akito', 'Initials': 'A', 'LastName': 'Tsutsumi', 'Affiliation': 'Internal Medicine, Takikawa City Hospital, Takikawa, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Furusaki', 'Affiliation': 'Sagawa Akira Rheumatology Clinic, Sapporo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Sagawa', 'Affiliation': 'Sagawa Akira Rheumatology Clinic, Sapporo, Japan.'}, {'ForeName': 'Kou', 'Initials': 'K', 'LastName': 'Katayama', 'Affiliation': 'Katayama Orthopaedic Rheumatology Clinic, Asahikawa, Japan.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Takeuchi', 'Affiliation': 'Aozora Takeuchi Internal Medicine Clinic, Sapporo, Japan.'}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Katsumata', 'Affiliation': 'Department of Rheumatology, Teine Keijinkai Hospital, Sapporo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kurita', 'Affiliation': 'Internal Medicine, Kitami Red Cross Hospital, Kitami, Japan.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Shane', 'Affiliation': 'International Medical Department, Hokkaido University Hospital, Sapporo, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Kato', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Graduate School of Medicine and Faculty of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Oku', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Graduate School of Medicine and Faculty of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Yasuda', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Graduate School of Medicine and Faculty of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Takahata', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medicine and Faculty of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Norimasa', 'Initials': 'N', 'LastName': 'Iwasaki', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medicine and Faculty of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Atsumi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Graduate School of Medicine and Faculty of Medicine, Hokkaido University, Sapporo, Japan.'}]",Modern rheumatology,['10.1080/14397595.2020.1812835'] 1263,32840767,Better Treatment Values in Local Application of Tranexamic Acid (TXA) than Intravenous Application with the Same Dose in Total Hip Arthroplasty.,"INTRODUCTION The aim of our study was to investigate the hemostatic effect of local and intravenously administered tranexamic acid (TXA) at the same dose in total hip arthroplasty. METHODS The prospective study included 72 patients who underwent total hip arthroplasty in our hospital between March 2018 and March 2019. The patients enrolled in the study were randomly divided into two groups: the observation group (36 patients were injected with 2.0 g TXA in 10 mL 0.9% NaCl using the joint cavity drainage tube after suturing the joint capsule) and the control group (36 patients were given an intravenous infusion of 2 g TXA in 200 mL 0.9% NaCl 30 min before the operation). In each patient, apparent blood loss, hidden blood loss, average blood transfusion, and the number of cases receiving blood transfusion were compared between the two groups after treatment. Hematocrit (Hct) and hemoglobin (Hb) levels were recorded at postoperative day (POD) 1, 2, 3, 7, and 10. We also recorded the levels of C-reactive protein (CRP) and interleukin-6 (IL-6) before the operation and 12 h postoperative and POD 1, 3, 7, and 10. The incidence of deep venous thrombosis and pulmonary embolism was also taken into account. RESULTS In the observation group, apparent blood loss, hidden blood loss, average blood transfusion volume, and the number of patients receiving blood transfusion were lower compared than the control group (P < 0.001). The levels of Hct and Hb were compared between the two groups at POD 1, 2, 3, 7, and 10, and the observation group reported higher levels of Hct and Hb (P < 0.001). The levels of CRP and IL-6 were compared between the two groups at POD 1, 3, 7, and 10, and the observation group reported lower levels of CRP and IL-6 than the control group (P < 0.001). On POD 7, there was no pulmonary embolism in both groups, and no significant difference was observed in the incidence of deep venous thrombosis between the two groups (P > 0.05). CONCLUSIONS Local and intravenous applications of TXA at the same dose are effective approaches in terms of reducing bleeding and inflammatory reaction with a good safety profile; however, the effect of local application had superior therapeutic values.",2020,"On POD 7, there was no pulmonary embolism in both groups, and no significant difference was observed in the incidence of deep venous thrombosis between the two groups (P > 0.05). ","['72 patients who underwent total hip arthroplasty in our hospital between March 2018 and March 2019', 'Total Hip Arthroplasty', 'total hip arthroplasty']","['intravenous infusion of 2\xa0g TXA', 'TXA in 10\xa0mL 0.9% NaCl using the joint cavity drainage tube after suturing the joint capsule', 'tranexamic acid (TXA', 'Tranexamic Acid (TXA', 'TXA']","['Hematocrit (Hct) and hemoglobin (Hb) levels', 'blood loss, hidden blood loss, average blood transfusion, and the number of cases receiving blood transfusion', 'pulmonary embolism', 'hemostatic effect', 'levels of Hct and Hb', 'incidence of deep venous thrombosis', 'apparent blood loss, hidden blood loss, average blood transfusion volume, and the number of patients receiving blood transfusion', 'incidence of deep venous thrombosis and pulmonary embolism', 'levels of CRP and IL-6', 'levels of C-reactive protein (CRP) and interleukin-6 (IL-6']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0502723', 'cui_str': 'Structure of joint cavity'}, {'cui': 'C0184114', 'cui_str': 'Tube drain'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0206207', 'cui_str': 'Structure of articular capsule'}]","[{'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",72.0,0.0284129,"On POD 7, there was no pulmonary embolism in both groups, and no significant difference was observed in the incidence of deep venous thrombosis between the two groups (P > 0.05). ","[{'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopaedics, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Desi', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': 'Department of Orthopaedics, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Wen', 'Affiliation': 'Department of Orthopaedics, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': 'Department of Orthopaedics, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China. panjiang@ccmu.edu.cn.'}]",Advances in therapy,['10.1007/s12325-020-01454-3'] 1264,32835786,Attachment anxiety moderates the effect of oxytocin on negative emotion recognition: Evidence from eye-movement data.,"Valence-specific effects of oxytocin have been revealed in a selection of preceding studies, while others report that oxytocin could improve facial recognition, regardless of emotion valence. The reported effect was mediated by increased eye gaze during face processing, and attachment style proved to moderate the effect of oxytocin administration on social behavior and cognition. In this study, we used eye tracking to test whether attachment style moderates the effect of oxytocin on negative emotion recognition, which is crucial for social cognition. We employed a placebo-controlled, double-blind, within-participants design. The participants were 73 healthy individuals (41 men) who received a single dose of intranasal oxytocin (24 IU) on one occasion and a placebo dose on another occasion. Visual attention to the eye region was assessed on both occasions, through the completion of an emotion recognition task. Our results showed that oxytocin increased participants' eye gaze towards facial expressions. Among participants who received oxytocin, as opposed to a placebo, only individuals with high attachment anxiety displayed more eye gaze and less mouth gaze towards facial expression, regardless of emotion valence. Our findings confirmed that oxytocin increases gaze to the eye region, thus improving facial recognition, regardless of emotion valence, this relationship was moderated by attachment anxiety. Further, our results highlighted the importance of considering individual differences when evaluating the effects of oxytocin on emotion recognition.",2020,"The reported effect was mediated by increased eye gaze during face processing, and attachment style proved to moderate the effect of oxytocin administration on social behavior and cognition.",['participants were 73 healthy individuals (41 men) who received a single dose of'],"['intranasal oxytocin', 'placebo', 'oxytocin']","['social behavior and cognition', 'eye gaze and less mouth gaze towards facial expression, regardless of emotion valence', 'emotion recognition', 'facial recognition, regardless of emotion valence', ""participants' eye gaze towards facial expressions"", 'eye gaze', 'negative emotion recognition']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037397', 'cui_str': 'Social behavior'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4505383', 'cui_str': 'Eye Gaze'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0871740', 'cui_str': 'Face Perception'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",73.0,0.296375,"The reported effect was mediated by increased eye gaze during face processing, and attachment style proved to moderate the effect of oxytocin administration on social behavior and cognition.","[{'ForeName': 'Tianyu', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing 400175, China.'}, {'ForeName': 'Qingting', 'Initials': 'Q', 'LastName': 'Tang', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing 400175, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing 400175, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing 400175, China. Electronic address: chenxu@swu.edu.cn.'}]","Pharmacology, biochemistry, and behavior",['10.1016/j.pbb.2020.173015'] 1265,32851644,"The Spectrum of Response to Erenumab in Patients With Episodic Migraine and Subgroup Analysis of Patients Achieving ≥50%, ≥75%, and 100% Response.","OBJECTIVE To assess the efficacy of erenumab at the ≥50%, ≥75%, and 100% reduction in monthly migraine days (MMD) response thresholds, using data from the 6-month double-blind treatment phase (DBTP) of the Study to Evaluate the Efficacy and Safety of Erenumab in Migraine Prevention (STRIVE) pivotal clinical trial. METHODS Enrolled patients with episodic migraine (EM; ≥4 MMD and <15 monthly headache days) were randomized (1:1:1) to erenumab 70 mg (n = 312), erenumab 140 mg (n = 318), or placebo (n = 316) once monthly. We determined the proportions of patients with ≥50%, ≥75% and 100% reduction in MMD over the last 3 months of the STRIVE DBTP (months 4 through 6) and conducted post hoc analyses to contextualize the treatment benefit in patient subgroups achieving, and not achieving, these response thresholds. Outcome measures included changes in MMD, acute migraine-specific medication days (MSMD), and patient-reported outcomes. RESULTS The proportions of patients with a reduction in MMD from baseline were greater for erenumab than for placebo at all response thresholds. As previously reported for the ≥50% response threshold, 135/312 (43.3%) of patients on erenumab 70 mg and 159/318 (50.0%) on erenumab 140 mg responded, vs 84/316 (26.6%) for placebo. At months 4 through 6, 65/312 (20.8%) and 70/318 (22.0%) of those on erenumab 70 mg and erenumab 140 mg, respectively, achieved ≥75% reductions vs 25/316 (7.9%) on placebo. A reduction of 100% response, which required no migraine days over 3 consecutive months based on observed data, was achieved by 10/312 (3.2%) of patients treated with erenumab 70 mg and 16/318 (5.0%) for erenumab 140 mg, vs 9/316 (2.8%) for placebo. At all response thresholds, responders achieved numerically greater reductions in mean MMD and MSMD, and greater improvements in disability than did the overall population; importantly, these remarkable responses were noted early. Meanwhile, 60/312 (19.2%) and 53/318 (16.7%) patients on erenumab 70 and 140 mg, respectively, had no reduction in MMD from baseline in months 4 through 6, compared with 104/316 (32.9%) patients on placebo. CONCLUSIONS The responses at the ≥50%, ≥75%, and 100% thresholds provide context for establishing realistic patient and physician expectations regarding the magnitude of treatment benefit that may be achieved by patients with EM responding to erenumab (STRIVE, NCT02456740).",2020,"At all response thresholds, responders achieved numerically greater reductions in mean MMD and MSMD, and greater improvements in disability than did the overall population; importantly, these remarkable responses were noted early.","['Enrolled patients with episodic migraine (EM; ≥4 MMD and <15 monthly headache days', 'Patients']","['placebo', 'Migraine Prevention', 'erenumab 70\xa0mg (n\xa0=\xa0312), erenumab 140\xa0mg (n\xa0=\xa0318), or placebo']","['mean MMD and MSMD', 'disability', 'changes in MMD, acute migraine-specific medication days (MSMD), and patient-reported outcomes', 'MMD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018681', 'cui_str': 'Headache'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C4542165', 'cui_str': 'erenumab'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C4319553', 'cui_str': '140'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1740836', 'cui_str': 'Acute migraine'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}]",,0.137358,"At all response thresholds, responders achieved numerically greater reductions in mean MMD and MSMD, and greater improvements in disability than did the overall population; importantly, these remarkable responses were noted early.","[{'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Broessner', 'Affiliation': 'Department of Neurology, Headache Outpatient Clinic, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Reuter', 'Affiliation': 'Department of Neurology, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Jo H', 'Initials': 'JH', 'LastName': 'Bonner', 'Affiliation': 'Mercy Clinic Neurology and Headache Centre, Saint Louis, MO, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': 'Department of Neurology, Mayo Clinic, Scottsdale, AZ, USA.'}, {'ForeName': 'Yngve', 'Initials': 'Y', 'LastName': 'Hallström', 'Affiliation': 'Neuro Center, St Görans Hospital, Stockholm, Sweden.'}, {'ForeName': 'Hernan', 'Initials': 'H', 'LastName': 'Picard', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Lenz', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Klatt', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Mikol', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}]",Headache,['10.1111/head.13929'] 1266,32819390,Circulating tumor DNA guided adjuvant chemotherapy in stage II colon cancer (MEDOCC-CrEATE): study protocol for a trial within a cohort study.,"BACKGROUND Accurate detection of patients with minimal residual disease (MRD) after surgery for stage II colon cancer (CC) remains an urgent unmet clinical need to improve selection of patients who might benefit form adjuvant chemotherapy (ACT). Presence of circulating tumor DNA (ctDNA) is indicative for MRD and has high predictive value for recurrent disease. The MEDOCC-CrEATE trial investigates how many stage II CC patients with detectable ctDNA after surgery will accept ACT and whether ACT reduces the risk of recurrence in these patients. METHODS/DESIGN MEDOCC-CrEATE follows the 'trial within cohorts' (TwiCs) design. Patients with colorectal cancer (CRC) are included in the Prospective Dutch ColoRectal Cancer cohort (PLCRC) and give informed consent for collection of clinical data, tissue and blood samples, and consent for future randomization. MEDOCC-CrEATE is a subcohort within PLCRC consisting of 1320 stage II CC patients without indication for ACT according to current guidelines, who are randomized 1:1 into an experimental and a control arm. In the experimental arm, post-surgery blood samples and tissue are analyzed for tissue-informed detection of plasma ctDNA, using the PGDx elio™ platform. Patients with detectable ctDNA will be offered ACT consisting of 8 cycles of capecitabine plus oxaliplatin while patients without detectable ctDNA and patients in the control group will standard follow-up according to guideline. The primary endpoint is the proportion of patients receiving ACT when ctDNA is detectable after resection. The main secondary outcome is 2-year recurrence rate (RR), but also includes 5-year RR, disease free survival, overall survival, time to recurrence, quality of life and cost-effectiveness. Data will be analyzed by intention to treat. DISCUSSION The MEDOCC-CrEATE trial will provide insight into the willingness of stage II CC patients to be treated with ACT guided by ctDNA biomarker testing and whether ACT will prevent recurrences in a high-risk population. Use of the TwiCs design provides the opportunity to randomize patients before ctDNA measurement, avoiding ethical dilemmas of ctDNA status disclosure in the control group. TRIAL REGISTRATION Netherlands Trial Register: NL6281/NTR6455 . Registered 18 May 2017, https://www.trialregister.nl/trial/6281.",2020,Presence of circulating tumor DNA (ctDNA) is indicative for MRD and has high predictive value for recurrent disease.,"['Patients with colorectal cancer (CRC', 'patients who might benefit form adjuvant chemotherapy (ACT', 'patients with minimal residual disease (MRD) after surgery for stage II colon cancer (CC', '1320 stage II CC patients without indication for ACT according to current guidelines', 'stage II colon cancer (MEDOCC-CrEATE']","['NL6281/NTR6455 ', 'ACT', 'capecitabine plus oxaliplatin']","['5-year RR, disease free survival, overall survival, time to recurrence, quality of life and cost-effectiveness', 'proportion of patients receiving ACT', '2-year recurrence rate (RR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0278479', 'cui_str': 'Carcinoma of colon, stage II'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]",,0.206776,Presence of circulating tumor DNA (ctDNA) is indicative for MRD and has high predictive value for recurrent disease.,"[{'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Schraa', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'van Rooijen', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'D E W', 'Initials': 'DEW', 'LastName': 'van der Kruijssen', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rubio Alarcón', 'Affiliation': 'Department of Pathology, Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Phallen', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sausen', 'Affiliation': 'Personal Genome Diagnostics, Baltimore, MD, 21224, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Simmons', 'Affiliation': 'Personal Genome Diagnostics, Baltimore, MD, 21224, USA.'}, {'ForeName': 'V M H', 'Initials': 'VMH', 'LastName': 'Coupé', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam University Medical Centers, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'W M U', 'Initials': 'WMU', 'LastName': 'van Grevenstein', 'Affiliation': 'Department of Surgical Oncology, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Elias', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Verkooijen', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Laclé', 'Affiliation': 'Department of Pathology, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'L J W', 'Initials': 'LJW', 'LastName': 'Bosch', 'Affiliation': 'Department of Pathology, Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'van den Broek', 'Affiliation': 'Department of Laboratory Medicine, Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.'}, {'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'Meijer', 'Affiliation': 'Department of Pathology, Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.'}, {'ForeName': 'V E', 'Initials': 'VE', 'LastName': 'Velculescu', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.'}, {'ForeName': 'R J A', 'Initials': 'RJA', 'LastName': 'Fijneman', 'Affiliation': 'Department of Pathology, Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.'}, {'ForeName': 'G R', 'Initials': 'GR', 'LastName': 'Vink', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Koopman', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands. m.koopman-6@umcutrecht.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC cancer,['10.1186/s12885-020-07252-y'] 1267,32819394,"Primary and secondary three-month outcomes of a cluster-randomized trial of home-based postpartum contraceptive delivery in southwest Trifinio, Guatemala.","DESIGN This a cluster-randomized parallel arm pragmatic trial to observe the association of home-based postpartum contraceptive provision, including the contraceptive implant, with implant utilization rates at 3 months post-enrollment. METHODS In a region of rural Guatemala referred to as the Southwest Trifinio, twelve communities are served by a community-based antenatal and postnatal care program. The communities were combined into eight clusters based on 2017 birth rates and randomized to receive the home-based contraceptive delivery (condoms, pills, injection, implant) during the routine 40-day postpartum visit. All participants receive comprehensive contraceptive counseling beginning at the first antenatal visit, so control clusters received this as part of routine care; this education preceded the study intervention. RESULTS Once the 12 communities were combined into 8 clusters by expected birth volume and nurse team, which we expected to translate to eventual postpartum visits, the allocation sequence was generated in SAS. Of 208 women enrolled in the study, 108 were in four intervention and 100 in four control clusters. We used descriptive statistics to produce counts and percentages of characteristics of the study population overall and by intervention arm followed by univariate modeling using a mixed effects regression adjusted for cluster. Three-month contraceptive initiation rates were 56.0% in the control clusters compared to 76.8% in the intervention clusters, p < 0.001. Women in control clusters overwhelmingly opted for the injectable contraceptive (94.6%) while women in intervention clusters chose both the injection (61.5%) and the implant (33.7%), p < 0.001. Implant use by 3 months, the primary outcome of the study, was significantly higher in the intervention arm (25.9%) compared to the control arm (3.6%), p < 0.001, RR 1.3 CI [1.2, 1.4]. CONCLUSION Our study was designed to respond to previously identified barriers to contraceptive uptake, and it was successful. Not only did it increase overall use of contraception by 3 months, but it shifted that contraceptive use away from short-acting methods in favor of longer-acting methods, with high continuation and satisfaction rates and no adverse outcomes reported. TRIAL REGISTRATION clinicaltrials.gov , NCT04005391 ; Retrospectively Registered 7/2/2019.",2020,"Three-month contraceptive initiation rates were 56.0% in the control clusters compared to 76.8% in the intervention clusters, p < 0.001.","['In a region of rural Guatemala referred to as the Southwest Trifinio, twelve communities are served by a community-based antenatal and postnatal care program', '208 women enrolled in the study, 108 were in four intervention and 100 in four control clusters']","['comprehensive contraceptive counseling', 'home-based contraceptive delivery (condoms, pills, injection, implant']",['contraceptive initiation rates'],"[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}]","[{'cui': 'C1443484', 'cui_str': 'Contraception care education'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]",208.0,0.0765249,"Three-month contraceptive initiation rates were 56.0% in the control clusters compared to 76.8% in the intervention clusters, p < 0.001.","[{'ForeName': 'Margo S', 'Initials': 'MS', 'LastName': 'Harrison', 'Affiliation': 'University of Colorado, Anschutz Medical Campus, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, CO, 80045, USA. margo.harrison@cuanschutz.edu.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Bunge-Montes', 'Affiliation': 'Fundación para la Salud Integral de los Guatemaltecos (FSIG), Quetzaltenango, Guatemala.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Rivera', 'Affiliation': 'Fundación para la Salud Integral de los Guatemaltecos (FSIG), Quetzaltenango, Guatemala.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Jimenez-Zambrano', 'Affiliation': 'University of Colorado, Anschutz Medical Campus, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, CO, 80045, USA.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Heinrichs', 'Affiliation': 'Denver Health, Denver, CO, USA.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Bolanos', 'Affiliation': 'Fundación para la Salud Integral de los Guatemaltecos (FSIG), Quetzaltenango, Guatemala.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Asturias', 'Affiliation': 'University of Colorado, Anschutz Medical Campus, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, CO, 80045, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Berman', 'Affiliation': 'University of Colorado, Anschutz Medical Campus, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, CO, 80045, USA.'}, {'ForeName': 'Jeanelle', 'Initials': 'J', 'LastName': 'Sheeder', 'Affiliation': 'University of Colorado, Anschutz Medical Campus, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, CO, 80045, USA.'}]",Reproductive health,['10.1186/s12978-020-00974-z'] 1268,32819399,"The CARDIA-trial protocol: a multinational, prospective, randomized, clinical trial comparing transthoracic esophagectomy with transhiatal extended gastrectomy in adenocarcinoma of the gastroesophageal junction (GEJ) type II.","BACKGROUND Adenocarcinoma of the gastroesophageal junction (GEJ) Siewert type II can be resected by transthoracic esophagectomy or transhiatal extended gastrectomy. Both allow for a complete tumor resection, yet there is an ongoing controversy about which surgical approach is superior with regards to quality of life, oncological outcomes and survival. While some studies suggest a better oncological outcome after transthoracic esophagectomy, others favor transhiatal extended gastrectomy for a better postoperative quality of life. To date, only retrospective studies are available, showing ambiguous results. METHODS This study is a multinational, multicenter, randomized, clinical superiority trial. Patients (n = 262) with a GEJ type II tumor resectable by both transthoracic esophagectomy and transhiatal extended gastrectomy will be enrolled in the trial. Type II tumors are defined as tumors with their midpoint between ≤1 cm proximal and ≤ 2 cm distal of the top of gastric folds on preoperative endoscopy. Patients will be included in one of the participating European sites and are randomized to either transthoracic esophagectomy or transhiatal extended gastrectomy. The trial is powered to show superiority for esophagectomy with regards to the primary efficacy endpoint overall survival. Key secondary endpoints are complete resection (R0), number and localization of tumor infiltrated lymph nodes at dissection, post-operative complications, disease-free survival, quality of life and cost-effectiveness. Postoperative survival and quality of life will be followed-up for 24 months after discharge. Further survival follow-up will be conducted as quarterly phone calls up to 60 months. DISCUSSION To date, as level 1 evidence is lacking, there is no consensus on which surgery is superior and both surgeries are used to treat GEJ type II carcinoma worldwide. The CARDIA trial is the first randomized trial to compare transthoracic esophagectomy versus transhiatal extended gastrectomy in patients with GEJ type II tumors. Several quality control measures were implemented in the protocol to ensure data reliability and increase the trial's significance. It is hypothesized that esophagectomy allows for a higher rate of radical resections and a more complete mediastinal lymph node dissection, resulting in a longer overall survival, while still providing an acceptable quality of life and cost-effectiveness. TRIAL REGISTRATION The trial was registered on August 2nd 2019 at the German Clinical Trials Register under the trial-ID DRKS00016923 .",2020,The CARDIA trial is the first randomized trial to compare transthoracic esophagectomy versus transhiatal extended gastrectomy in patients with GEJ type II tumors.,"['Adenocarcinoma of the gastroesophageal junction (GEJ', 'Patients (n = 262) with a GEJ type II tumor resectable by both', 'in adenocarcinoma of the gastroesophageal junction (GEJ) type II', 'patients with GEJ type II tumors']","['transthoracic esophagectomy with transhiatal extended gastrectomy', 'transthoracic esophagectomy and transhiatal extended gastrectomy', 'transthoracic esophagectomy or transhiatal extended gastrectomy', 'transthoracic esophagectomy versus transhiatal extended gastrectomy']","['postoperative quality of life', 'complete resection (R0), number and localization of tumor infiltrated lymph nodes at dissection, post-operative complications, disease-free survival, quality of life and cost-effectiveness', 'Postoperative survival and quality of life']","[{'cui': 'C1332166', 'cui_str': 'Adenocarcinoma of the gastroesophageal junction'}, {'cui': 'C0014871', 'cui_str': 'Cardioesophageal junction structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]","[{'cui': 'C0205503', 'cui_str': 'Transthoracic approach'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015250', 'cui_str': 'Complete excision'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0037710', 'cui_str': 'Auditory localization'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",262.0,0.18429,The CARDIA trial is the first randomized trial to compare transthoracic esophagectomy versus transhiatal extended gastrectomy in patients with GEJ type II tumors.,"[{'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Leers', 'Affiliation': 'Department of General, Visceral, Cancer and Transplantation Surgery, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Knepper', 'Affiliation': 'Department of General, Visceral, Cancer and Transplantation Surgery, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany. laura.knepper@uk-koeln.de.'}, {'ForeName': 'Arjen', 'Initials': 'A', 'LastName': 'van der Veen', 'Affiliation': 'Department of Surgical Oncology, University Medical Center Utrecht, Heidelberglaan 100, 3584, CX, Utrecht, The Netherlands.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Schröder', 'Affiliation': 'Department of General, Visceral, Cancer and Transplantation Surgery, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Fuchs', 'Affiliation': 'Department of General, Visceral, Cancer and Transplantation Surgery, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Schiller', 'Affiliation': 'Institute of Medical Statistics and Computational Biology, University of Cologne, Robert-Koch-Str. 10, 50931, Cologne, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hellmich', 'Affiliation': 'Institute of Medical Statistics and Computational Biology, University of Cologne, Robert-Koch-Str. 10, 50931, Cologne, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Zettelmeyer', 'Affiliation': 'Clinical Trials Centre Cologne, University of Cologne, Gleueler Str. 269, 50935, Cologne, Germany.'}, {'ForeName': 'Lodewijk A A', 'Initials': 'LAA', 'LastName': 'Brosens', 'Affiliation': 'Department of Pathology, University Medical Center Utrecht, Heidelberglaan 100, 3584, CX, Utrecht, The Netherlands.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Quaas', 'Affiliation': 'Institute for Pathology, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany.'}, {'ForeName': 'Jelle P', 'Initials': 'JP', 'LastName': 'Ruurda', 'Affiliation': 'Department of Surgical Oncology, University Medical Center Utrecht, Heidelberglaan 100, 3584, CX, Utrecht, The Netherlands.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'van Hillegersberg', 'Affiliation': 'Department of Surgical Oncology, University Medical Center Utrecht, Heidelberglaan 100, 3584, CX, Utrecht, The Netherlands.'}, {'ForeName': 'Christiane J', 'Initials': 'CJ', 'LastName': 'Bruns', 'Affiliation': 'Department of General, Visceral, Cancer and Transplantation Surgery, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany.'}]",BMC cancer,['10.1186/s12885-020-07152-1'] 1269,32826102,The role of peer support education model on the quality of life and self-care behaviors of patients with myocardial infarction.,"OBJECTIVE This study aimed to assess the effect of peer education on the quality of life and self-care behaviors of patients with myocardial infarction. METHODS In this clinical trial, 70 patients with myocardial infarction meeting the inclusion criteria were assigned to experimental (n = 35) or control (n = 35) groups using block randomization. Patients in the intervention group received two one-hour training sessions on the third day after myocardial infarction during the CCU stay along with routine care. Education intervention was performed by peers. The control group will follow routine care. All patients selected were assessed using McNews' quality of life questionnaire and Miller self-care questionnaire, respectively before the intervention and also one month after discharge. Chi-square and t-test were used to analyze the data. RESULTS After the intervention, the mean of quality of life and the mean score of self-care behaviors in the experimental group were significantly higher compared to the control group. CONCLUSIONS According to the results, to improve the quality of life and promote the self-care behaviors in such patients, using peer education along with healthcare professionals is recommended. PRACTICE IMPLICATION This patient education approach had a significant impact on quality of life and self-care behavior.",2021,"After the intervention, the mean of quality of life and the mean score of self-care behaviors in the experimental group were significantly higher compared to the control group. ","['patients with myocardial infarction', '70 patients with myocardial infarction meeting the inclusion criteria']","['peer support education model', 'peer education']","['quality of life and self-care behaviors', 'mean of quality of life and the mean score of self-care behaviors', 'quality of life and self-care behavior', ""McNews' quality of life questionnaire and Miller self-care questionnaire"", 'quality of life and promote the self-care behaviors']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0402830', 'cui_str': 'Miller'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]",70.0,0.0316886,"After the intervention, the mean of quality of life and the mean score of self-care behaviors in the experimental group were significantly higher compared to the control group. ","[{'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Ebrahimi', 'Affiliation': 'Randomized Controlled Trial Research Center, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Abbasi', 'Affiliation': 'Department of Nursing, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Bagheri', 'Affiliation': 'Department of Nursing, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Mohammad Hasan', 'Initials': 'MH', 'LastName': 'Basirinezhad', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Shakeri', 'Affiliation': 'Department of Nursing, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Mohammadpourhodki', 'Affiliation': 'Department of Nursing, Kashmar Center of Higher Health Education, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: mohammadpourhr@mums.ac.ir.'}]",Patient education and counseling,['10.1016/j.pec.2020.08.002'] 1270,32827200,Effect of the exercise programme on the quality of life of prostate cancer survivors: A randomized controlled trial.,"AIM The aim of this study was to investigate the effect of the exercise programme on the quality of life of prostate cancer (PCa) survivors. METHODS A randomized controlled, parallel trial was conducted from April 2017 to January 2018 on 80 PCa survivors. They were randomly assigned to intervention and control groups (n = 40 in each group). The exercise programme was designed based on the self-management approach (SMA). The intervention group participated in a 12-week exercise programme consisting of one session of group exercise and three sessions of individual exercise per week using exercise facilities in the community. Data were collected using the quality of life questionnaires and the follow-up checklist. RESULTS In the intervention group, statistically significant improvements in physical, role, emotional, social and sexual functions were reported. Also, the patients in this group reported reduced fatigue, insomnia, constipation, diarrhoea, urinary, bowel and hormonal treatment-related symptoms in comparison with before the exercise programme (p < 0.05). CONCLUSIONS Nurses are suggested to plan for improving the participation of PCa survivors in exercise programmes using exercise facilities in the community in order to reduce the complications of treatment and improve their quality of life.",2021,"Also, the patients in this group reported reduced fatigue, insomnia, constipation, diarrhoea, urinary, bowel and hormonal treatment-related symptoms in comparison with before the exercise programme (p < 0.05). ","['April 2017 to January 2018 on 80 PCa survivors', 'prostate cancer survivors']","['exercise programme consisting of one session of group exercise and three sessions of individual exercise per week using exercise facilities', 'exercise programme']","['quality of life', 'physical, role, emotional, social and sexual functions', 'reduced fatigue, insomnia, constipation, diarrhoea, urinary, bowel and hormonal treatment-related symptoms', 'quality of life of prostate cancer (PCa) survivors', 'quality of life questionnaires']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0203986', 'cui_str': 'Individual exercises'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0459299,"Also, the patients in this group reported reduced fatigue, insomnia, constipation, diarrhoea, urinary, bowel and hormonal treatment-related symptoms in comparison with before the exercise programme (p < 0.05). ","[{'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Mardani', 'Affiliation': 'Nursing Care Research Center, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shadan', 'Initials': 'S', 'LastName': 'Pedram Razi', 'Affiliation': 'Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Mazaheri', 'Affiliation': 'Department of Sports and Exercise Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Haghani', 'Affiliation': 'Nursing Care Research Center, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Vaismoradi', 'Affiliation': 'Faculty of Nursing and Health Sciences, Nord University, Bodø, Norway.'}]",International journal of nursing practice,['10.1111/ijn.12883'] 1271,32829666,Effects of Intensive Versus Standard Office-Based Hypertension Treatment Strategy on White-Coat Effect and Masked Uncontrolled Hypertension: From the SPRINT ABPM Ancillary Study.,"Guidelines recommend using out-of-office blood pressure (BP) measurements to confirm the diagnoses of hypertension and in the titration of antihypertensive medication. The prevalence of out-of-office BP phenotypes for an office systolic/diastolic BP goal <140/90 mm Hg has been reported. However, the prevalence of these phenotypes when targeting an office systolic/diastolic BP goal <120/80 is unknown. The SPRINT (Systolic Blood Pressure Intervention Trial) Ambulatory BP Ancillary study evaluated out-of-office BP using ambulatory BP monitoring in 897 participants 27 months after randomization to intensive versus standard BP targets (office systolic BP <120 versus <140 mm Hg). We used office and daytime BP to assess the proportion of participants with white-coat effect (standard target: office BP ≥140/90 mm Hg and daytime BP <135/85 mm Hg versus intensive target: office BP ≥120/80 mm Hg and daytime BP <120/80 mm Hg) and masked uncontrolled hypertension (standard target: office BP <140/90 mm Hg and daytime BP ≥135/85 mm Hg versus intensive target: office BP <120/80 mm Hg and daytime BP ≥120/80 mm Hg) in each treatment arm. The prevalence of white-coat effect and masked uncontrolled hypertension was 9% and 34%, in both treatment groups. Among participants with uncontrolled office BP, white-coat effect was present in 20% and 23% in the intensive and standard groups, respectively. Among participants with controlled office BP, masked uncontrolled hypertension was present in 62% and 56% in the intensive and standard groups, respectively. In conclusion, a more intensive BP target resulted in a similar proportion of patients with white-coat effect and masked uncontrolled hypertension compared with a standard target.",2020,"The prevalence of white-coat effect and masked uncontrolled hypertension was 9% and 34%, in both treatment groups.","['897 participants 27 months after randomization to intensive versus standard BP targets (office systolic BP <120 versus <140 mm Hg', 'White-Coat Effect and Masked Uncontrolled Hypertension', 'participants with white-coat effect (standard target']",['Intensive Versus Standard Office-Based Hypertension Treatment Strategy'],"['prevalence of white-coat effect and masked uncontrolled hypertension', 'uncontrolled hypertension']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0578998', 'cui_str': 'On treatment for hypertension'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}]",27.0,0.101849,"The prevalence of white-coat effect and masked uncontrolled hypertension was 9% and 34%, in both treatment groups.","[{'ForeName': 'Lama', 'Initials': 'L', 'LastName': 'Ghazi', 'Affiliation': 'From the Division of Renal Diseases and Hypertension, University of Minnesota, Minneapolis (L.G., P.E.D.).'}, {'ForeName': 'Laura P', 'Initials': 'LP', 'LastName': 'Cohen', 'Affiliation': 'The Columbia Hypertension Center, Columbia University, New York, NY (L.P.C., D.S.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Muntner', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Alabama at Birmingham (P.M.).'}, {'ForeName': 'Daichi', 'Initials': 'D', 'LastName': 'Shimbo', 'Affiliation': 'The Columbia Hypertension Center, Columbia University, New York, NY (L.P.C., D.S.).'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Drawz', 'Affiliation': 'From the Division of Renal Diseases and Hypertension, University of Minnesota, Minneapolis (L.G., P.E.D.).'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.15300'] 1272,32841523,Intensive Weight Loss Intervention and Cancer Risk in Adults with Type 2 Diabetes: Analysis of the Look AHEAD Randomized Clinical Trial.,"OBJECTIVE This study was designed to determine whether intensive lifestyle intervention (ILI) aimed at weight loss lowers cancer incidence and mortality. METHODS Data from the Look AHEAD trial were examined to investigate whether participants randomized to ILI designed for weight loss would have reduced overall cancer incidence, obesity-related cancer incidence, and cancer mortality, as compared with the diabetes support and education (DSE) comparison group. This analysis included 4,859 participants without a cancer diagnosis at baseline except for nonmelanoma skin cancer. RESULTS After a median follow-up of 11 years, 684 participants (332 in ILI and 352 in DSE) were diagnosed with cancer. The incidence rates of obesity-related cancers were 6.1 and 7.3 per 1,000 person-years in ILI and DSE, respectively, with a hazard ratio (HR) of 0.84 (95% CI: 0.68-1.04). There was no significant difference between the two groups in total cancer incidence (HR, 0.93; 95% CI: 0.80-1.08), incidence of nonobesity-related cancers (HR, 1.02; 95% CI: 0.83-1.27), or total cancer mortality (HR, 0.92; 95% CI: 0.68-1.25). CONCLUSIONS An ILI aimed at weight loss lowered incidence of obesity-related cancers by 16% in adults with overweight or obesity and type 2 diabetes. The study sample size likely lacked power to determine effect sizes of this magnitude and smaller.",2020,"There was no significant difference between the two groups in total cancer incidence (HR, 0.93; 95% CI: 0.80-1.08), incidence of nonobesity-related cancers (HR, 1.02; 95% CI: 0.83-1.27), or total cancer mortality (HR, 0.92; 95% CI: 0.68-1.25). ","['Adults with Type 2 Diabetes', '684 participants (332 in ILI and 352 in DSE) were diagnosed with cancer', 'adults with overweight or obesity and type 2 diabetes', '4,859 participants without a cancer diagnosis at baseline except for nonmelanoma skin cancer']","['Intensive Weight Loss Intervention', 'intensive lifestyle intervention (ILI']","['total cancer mortality', 'incidence of nonobesity-related cancers', 'incidence rates of obesity-related cancers', 'overall cancer incidence, obesity-related cancer incidence, and cancer mortality', 'total cancer incidence']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332300', 'cui_str': 'Except for'}, {'cui': 'C0699893', 'cui_str': 'Skin carcinoma'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",4859.0,0.156537,"There was no significant difference between the two groups in total cancer incidence (HR, 0.93; 95% CI: 0.80-1.08), incidence of nonobesity-related cancers (HR, 1.02; 95% CI: 0.83-1.27), or total cancer mortality (HR, 0.92; 95% CI: 0.68-1.25). ","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Hsin-Chieh', 'Initials': 'HC', 'LastName': 'Yeh', 'Affiliation': 'Departments of Medicine, Epidemiology, and Oncology, Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Bantle', 'Affiliation': 'Department of Medicine, University of Minnesota Medical School, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Cassidy-Begay', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix Epidemiology and Clinical Research Branch, Phoenix, Arizona, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Blackburn', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Bray', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Byers', 'Affiliation': 'Department of Epidemiology, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Jeanne M', 'Initials': 'JM', 'LastName': 'Clark', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Mace', 'Initials': 'M', 'LastName': 'Coday', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Egan', 'Affiliation': 'Psychiatry and Human Behavior, The Warren Alpert Medical School of Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Espeland', 'Affiliation': 'Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Foreyt', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Katelyn', 'Initials': 'K', 'LastName': 'Garcia', 'Affiliation': 'Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Goldman', 'Affiliation': 'Diabetes Clinical Research Center, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Edward W', 'Initials': 'EW', 'LastName': 'Gregg', 'Affiliation': 'Department of Epidemiology and Biostatistics, Imperial College London, London, UK.'}, {'ForeName': 'Helen P', 'Initials': 'HP', 'LastName': 'Hazuda', 'Affiliation': 'Department of Medicine, The University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Hesson', 'Affiliation': 'Center for Weight and Eating Disorders, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'James O', 'Initials': 'JO', 'LastName': 'Hill', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Horton', 'Affiliation': 'Department of Medicine, Joslin Diabetes Center, Boston, Massachusetts, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Jakicic', 'Affiliation': 'Department of Health and Physical Activity, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Jeffery', 'Affiliation': 'Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': 'Department of Medicine, VA Puget Sound Health Care System / University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Knowler', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix Epidemiology and Clinical Research Branch, Phoenix, Arizona, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Korytkowski', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kure', 'Affiliation': 'Department of Medicine, VA Puget Sound Health Care System / University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Cora E', 'Initials': 'CE', 'LastName': 'Lewis', 'Affiliation': 'Division of Preventive Medicine, School of Medicine, The University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Mantzoros', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Meacham', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix Epidemiology and Clinical Research Branch, Phoenix, Arizona, USA.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Montez', 'Affiliation': 'Department of Medicine, The University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Nathan', 'Affiliation': 'Diabetes Clinical Research Center, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Pajewski', 'Affiliation': 'Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Patricio', 'Affiliation': 'Columbia University Medical Center, New York, New York, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Peters', 'Affiliation': 'Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Xavier Pi-Sunyer', 'Affiliation': 'Columbia University Medical Center, New York, New York, USA.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Pownall', 'Affiliation': 'Division of Cardiology, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Donna H', 'Initials': 'DH', 'LastName': 'Ryan', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Safford', 'Affiliation': 'Department of Medicine, Weill Cornell Medical College of Cornell University, New York, New York, USA.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Sedjo', 'Affiliation': 'Department of Community and Behavioral Health, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Steinburg', 'Affiliation': 'Department of Medicine, University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Vitolins', 'Affiliation': 'Department of Epidemiology and Prevention, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Center for Weight and Eating Disorders, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Lynne E', 'Initials': 'LE', 'LastName': 'Wagenknecht', 'Affiliation': 'Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'Psychiatry and Human Behavior, The Warren Alpert Medical School of Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Wolff', 'Affiliation': 'Department of Oncology, The Johns Hopkins Sydney Kimmel Cancer Center, Baltimore, Maryland, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Wyatt', 'Affiliation': 'Department of Medicine, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Susan Z', 'Initials': 'SZ', 'LastName': 'Yanovski', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22936'] 1273,32851483,Acute effects of inspiratory muscle training at different intensities in healthy young people.,"BACKGROUND Understanding the acute effects of inspiratory muscle training (IMT) at different intensities on the autonomic nervous system, arterial stiffness, and blood pressure in healthy young people will be important in the constitution of appropriate IMT prescriptions. AIMS To investigate the acute effects of IMT at different intensities on autonomic function, arterial stiffness, and blood pressure in healthy young people METHODS: Thirty-six healthy participants were enrolled in this crossover study. All participants randomly performed IMT sessions, which consisted of diaphragmatic breathing exercise (DBE), 10%, 30%, and 60% of maximal inspiratory pressure (MIP) on consecutive days. Autonomic function and arterial stiffness were assessed by measuring heart rate variability (HRV) and aortic pulse wave velocity (AoPWV), respectively. HRV, AoPWV, and blood pressure were recorded before and immediately after each IMT session. RESULTS There was no significant difference in the baseline measurements between IMT sessions (p > 0.05). Heart rate (HR) significantly decreased after DBE and IMT at 10% of MIP (p < 0.05). All time domain parameters of HRV significantly improved after DBE compared with the baseline (p < 0.05). There was no difference in the frequency domain of HRV after the IMT sessions (p > 0.05). AoPWV significantly increased after IMT at 60% of MIP (p < 0.05). Mean arterial pressure significantly changed after DBE and IMT at 60% of MIP (p < 0.05). CONCLUSIONS A single session of DBE positively affects autonomic function and blood pressure, while IMT at 60% of MIP increases arterial stiffness. The different intensities of IMT have various impacts on autonomic function, arterial stiffness, and blood pressure. TRIAL REGISTRATION NCT03788356.",2021,"Mean arterial pressure significantly changed after DBE and IMT at 60% of MIP (p < 0.05). ","['healthy young people METHODS', 'healthy young people', 'Thirty-six healthy participants']","['IMT', 'maximal inspiratory pressure (MIP', 'diaphragmatic breathing exercise (DBE', 'inspiratory muscle training (IMT', 'inspiratory muscle training']","['HRV, AoPWV, and blood pressure', 'frequency domain of HRV', 'autonomic function, arterial stiffness, and blood pressure', 'Autonomic function and arterial stiffness', 'autonomic function and blood pressure', 'Heart rate (HR', 'Mean arterial pressure', 'AoPWV', 'heart rate variability (HRV) and aortic pulse wave velocity (AoPWV']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0454509', 'cui_str': 'Diaphragmatic breathing exercises'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",36.0,0.0436921,"Mean arterial pressure significantly changed after DBE and IMT at 60% of MIP (p < 0.05). ","[{'ForeName': 'Aylin', 'Initials': 'A', 'LastName': 'Tanriverdi', 'Affiliation': 'Graduate School of Health Sciences, Dokuz Eylül University, Izmir, Turkey. tanrverdiaylin@gmail.com.'}, {'ForeName': 'Buse Ozcan', 'Initials': 'BO', 'LastName': 'Kahraman', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Dokuz Eylül University, Izmir, Turkey.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Ozsoy', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Selcuk University, Konya, Turkey.'}, {'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Ozpelit', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, Dokuz Eylül University, Izmir, Turkey.'}, {'ForeName': 'Sema', 'Initials': 'S', 'LastName': 'Savci', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Dokuz Eylül University, Izmir, Turkey.'}]",Irish journal of medical science,['10.1007/s11845-020-02353-w'] 1274,32851876,Variants of opioid genes and response to treatment of opioid use disorder with buprenorphine-naloxone versus extended-release naltrexone in Caucasians.,"Background : Sublingual buprenorphine-naloxone (BUP-NX), an FDA-approved treatment for opioid use disorder (OUD), combines buprenorphine (a partial mu/kappa agonist) with naloxone (a mu/ kappa antagonist). Extended-release injection naltrexone (XR-NTX; a mu receptor antagonist and kappa receptor partial agonist) is also an FDA-approved treatment for OUD. However, while some patients respond well to these medications, many others leave treatment and relapse. Objectives : Determine whether gene variants in the opioid gene system are associated with better or worse treatment response. Methods : In a 24-week, multisite, randomized, comparative effectiveness trial of daily, sublingual self-administration of BUP-NX versus monthly injection of XR-NTX conducted in the National Drug Abuse Clinical Trials Network, DNA was collected and four opioid gene variants were evaluated: (1) mu opioid receptor 118A>G; (2) 68-bp repeat in prodynorphin; (3) prodynorphin SNP rs910080; and (4) kappa opioid receptor SNP rs6473797. In non-Hispanic Caucasians ( N = 334), two outcomes measures were assessed: received first dose (yes/no) and received last dose (yes/no). Separate logistic regressions were used to model each outcome measure as a function of treatment (XR-NTX vs BUP-NX), each gene variant, and their interaction. Results : There were no significant main effects of gene variant on receiving first dose or last dose. There were also no significant gene variant by treatment interactions. Conclusions : The outcome of treatment of OUD with medications is likely a complex function of multiple factors, including environmental, psychosocial, and possibly genetic, such that major effects of genetic variants may be unlikely.",2020,There were no significant main effects of gene variant on receiving first dose or last dose.,['Caucasians'],"['buprenorphine-naloxone (BUP-NX', 'naltrexone (XR-NTX', 'buprenorphine-naloxone', 'sublingual self-administration of BUP-NX versus monthly injection of XR-NTX', 'naloxone', 'buprenorphine']",[],"[{'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C1169989', 'cui_str': 'Buprenorphine- and naloxone-containing product'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C0036589', 'cui_str': 'Self-administration of medication'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}]",[],,0.0209085,There were no significant main effects of gene variant on receiving first dose or last dose.,"[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Randesi', 'Affiliation': 'Laboratory of the Biology of Addictive Diseases, the Rockefeller University , New York, NY, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rotrosen', 'Affiliation': 'Department of Psychiatry, NYU Grossman School of Medicine , New York, NY, USA.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'Department of Psychiatry, New York State Psychiatric Institute, Columbia University Medical Center , New York, NY, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Lee', 'Affiliation': 'Department of Population Health, NYU Grossman School of Medicine , New York, NY, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Novo', 'Affiliation': 'Department of Psychiatry, NYU Grossman School of Medicine , New York, NY, USA.'}, {'ForeName': 'Orna', 'Initials': 'O', 'LastName': 'Levran', 'Affiliation': 'Laboratory of the Biology of Addictive Diseases, the Rockefeller University , New York, NY, USA.'}, {'ForeName': 'Jurg', 'Initials': 'J', 'LastName': 'Ott', 'Affiliation': 'Laboratory of Statistical Genetics, the Rockefeller University , New York, NY, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': 'Department of Biostatistics, Columbia University Mailman School of Public Health , New York, NY, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Scodes', 'Affiliation': 'Division of Mental Health Data Science, New York State Psychiatric Institute , New York, NY, USA.'}, {'ForeName': 'Mary Jeanne', 'Initials': 'MJ', 'LastName': 'Kreek', 'Affiliation': 'Laboratory of the Biology of Addictive Diseases, the Rockefeller University , New York, NY, USA.'}]",The American journal of drug and alcohol abuse,['10.1080/00952990.2020.1797064'] 1275,32853634,Relationship Between Combined Histologic and Endoscopic Endpoints and Efficacy of Ustekinumab Treatment in Patients With Ulcerative Colitis.,"BACKGROUND & AIMS Ustekinumab induces and maintains histologic improvement in patients with ulcerative colitis (UC). The clinical relevance of this endpoint alone, and in combination with endoscopic improvement, is unknown. METHODS Histologic disease activity was evaluated in 2630 colonic biopsy samples from patients with UC treated in the UNIFI phase 3 UC clinical studies of ustekinumab. We evaluated associations between histologic improvement (defined as the composite of neutrophil infiltration in less than 5% of crypts and no crypt destruction, erosions, ulcerations, or granulation tissue) and clinical endpoints at the end of induction (week 8 and 16) and maintenance (week 44) periods. We assessed the validity of a combined histologic and endoscopic (Mayo endoscopy subscore, 0 or 1) improvement endpoint, which we called histo-endoscopic mucosal healing (or histo-endoscopic mucosal improvement). RESULTS Histologic improvement was significantly (P < .0001) associated with clinical remission, lower mean disease activity scores, and greater improvement in disease activity at the end of induction and maintenance studies. Ustekinumab induced and maintained significantly higher rates of histologic improvement at induction week 8 and maintenance week 44 than placebo when more stringent definitions of histologic improvement were used. Histologic improvement and endoscopic improvement following induction were associated with 10% to 20% higher rates of histo-endoscopic mucosal healing, clinical remission, and corticosteroid-free remission at week 44 (all P < .05) in patients who received ustekinumab maintenance therapy. At week 44, 61% of patients (56/92) with histo-endoscopic mucosal healing after induction therapy achieved clinical remission, versus 39% of patients (9/23, P = .0983) and 34% of patients (24/71, P = .0009) with endoscopic or histologic improvement alone after induction, respectively. CONCLUSION Data from the UNIFI program of ustekinumab in patients with UC treated with ustekinumab indicated the achievement of histo-endoscopic mucosal healing after induction therapy is associated with lower disease activity at the end of maintenance therapy than either histologic or endoscopic improvement alone. ClinicalTrials.gov number: NCT02407236.",2020,Ustekinumab induced and maintained significantly higher rates of histologic improvement at induction week 8 and maintenance week 44 than placebo when more stringent definitions of histologic improvement were used.,"['Patients With Ulcerative Colitis', 'patients with ulcerative colitis (UC', '2630 colonic biopsy samples from patients with UC treated in the UNIFI phase 3 UC clinical studies of ustekinumab']","['Ustekinumab Treatment', 'ustekinumab maintenance therapy', 'placebo']","['disease activity', 'rates of histologic improvement', 'achievement of histo-endoscopic mucosal healing', 'clinical remission', 'clinical remission, lower mean disease activity scores', 'validity of a combined histologic and endoscopic (Mayo endoscopy subscore, 0 or 1) improvement endpoint which we called histo-endoscopic mucosal healing (or histo-endoscopic mucosal improvement', 'crypt destruction, erosions, ulcerations, or granulation tissue) and clinical endpoints', 'histo-endoscopic mucosal healing, clinical remission, and corticosteroid-free remission', 'Histologic improvement', 'Histologic improvement and endoscopic improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0586716', 'cui_str': 'Colonic biopsy sample'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}]","[{'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C1261381', 'cui_str': 'Destructive procedure'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0018180', 'cui_str': 'Granulation tissue'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",2630.0,0.0468271,Ustekinumab induced and maintained significantly higher rates of histologic improvement at induction week 8 and maintenance week 44 than placebo when more stringent definitions of histologic improvement were used.,"[{'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Immunology, Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Marano', 'Affiliation': 'Immunology, Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Immunology, Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Feifei', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Immunology, Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'Division of Gastroenterology, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Bruce E', 'Initials': 'BE', 'LastName': 'Sands', 'Affiliation': 'Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Feagan', 'Affiliation': 'Robarts Clinical Trials, Robarts Research Institute, Western University, London, Ontario, Canada.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Rubin', 'Affiliation': 'Inflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, Illinois.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Peyrin-Biroulet', 'Affiliation': 'Gastroenterology Department and Inserm U1256 Nutrition, Genetics, and Environmental Risk Exposure, Nancy University Hospital, Université de Lorraine, Nancy, France.'}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Friedman', 'Affiliation': 'Immunology, Janssen Research & Development, LLC, Spring House, Pennsylvania. Electronic address: joshfriedman@me.com.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'De Hertogh', 'Affiliation': 'Deparment of Pathology, University Hospitals KU Leuven, Belgium. Electronic address: gert.dehertogh@uzleuven.be.'}]",Gastroenterology,['10.1053/j.gastro.2020.08.037'] 1276,32854734,Engaging parents in digital sexual and reproductive health education: evidence from the JACK trial.,"BACKGROUND Research evidence and international policy highlight the central role that parents play in promoting positive sexual behaviour and outcomes in their children, however they can be difficult to engage in sexual and reproductive health (SRH) education programmes. Digital health promotion that uses online and mobile technologies (OMTs) to promote parent-child communication may offer an innovative solution to reach parents, however, few programmes have used OMTs to involve parents in SRH, and none have reported lessons learned in relation to optimising engagement. This study addresses this gap in the literature by reporting acceptability and feasibility of using OMTs to engage parents in SRH education. Findings will be relevant for those wishing to develop and implement digital SRH programmes with parents internationally. METHODS The Jack Trial is a UK-wide cluster randomised controlled trial recruiting over 8000 adolescents from 66 socially and religiously diverse post-primary schools. An embedded mixed-methods process evaluation explored user engagement with parent components of the If I Were Jack SRH education programme, which include online animated films and a parent-teen homework exercise. RESULTS A total of 109 adolescents, teachers, parents and SRH policy experts took part in semi-structured interviews and focus groups, 134 parents responded to an online survey, and 3179 adolescents completed a programme engagement and satisfaction questionnaire. Parents who accessed the materials were positive about them; 87% rated them as 'good or excellent' and 67% said they helped them have conversations with their child about SRH. Web analytics revealed that 27% of contacted parents accessed the digital materials, with 9% viewing the animated films. Only 38% of teachers implemented the homework exercise, mainly because they assumed that students would not complete it or it might result in backlash from parents. CONCLUSIONS While digital parental materials show promise for engaging parents in SRH education, this study suggests that in order to optimise engagement, parental components that give parents the necessary skills to have conversations with their children about sex should be coupled with efforts to increase school and teacher confidence to communicate with parents on sensitive topics. TRIAL REGISTRATION ISRCTN99459996 .",2020,"An embedded mixed-methods process evaluation explored user engagement with parent components of the If I Were Jack SRH education programme, which include online animated films and a parent-teen homework exercise. ","['109 adolescents, teachers, parents and SRH policy experts took part in semi-structured interviews and focus groups, 134 parents responded to an online survey, and 3179 adolescents completed a programme engagement and satisfaction questionnaire', '8000 adolescents from 66 socially and religiously diverse post-primary schools', 'Engaging parents in digital sexual and reproductive health education']",['OMTs'],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3840857', 'cui_str': '8000'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}]",[],8000.0,0.111774,"An embedded mixed-methods process evaluation explored user engagement with parent components of the If I Were Jack SRH education programme, which include online animated films and a parent-teen homework exercise. ","[{'ForeName': 'Áine', 'Initials': 'Á', 'LastName': 'Aventin', 'Affiliation': ""School of Nursing & Midwifery and Centre for Evidence and Social Innovation, Queen's University Belfast, Belfast, Northern Ireland, UK. a.aventin@qub.ac.uk.""}, {'ForeName': 'Aisling', 'Initials': 'A', 'LastName': 'Gough', 'Affiliation': ""School of Nursing & Midwifery and Centre for Evidence and Social Innovation, Queen's University Belfast, Belfast, Northern Ireland, UK.""}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'McShane', 'Affiliation': ""School of Nursing & Midwifery and Centre for Evidence and Social Innovation, Queen's University Belfast, Belfast, Northern Ireland, UK.""}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Gillespie', 'Affiliation': ""School of Nursing & Midwifery and Centre for Evidence and Social Innovation, Queen's University Belfast, Belfast, Northern Ireland, UK.""}, {'ForeName': 'Liam', 'Initials': 'L', 'LastName': ""O'Hare"", 'Affiliation': ""School of Social Sciences, Education and Social Work and Centre for Evidence and Social Innovation, Queen's University Belfast, Belfast, Northern Ireland, UK.""}, {'ForeName': 'Honor', 'Initials': 'H', 'LastName': 'Young', 'Affiliation': 'School of Social Sciences, Cardiff University, Cardiff, Wales, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Lewis', 'Affiliation': 'MRC/CSO Social and Public Health Sciences Unit, Univeristy of Glasgow, Glasgow, Scotland, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Warren', 'Affiliation': 'Department of Public Health Environments and Society, London School of Hygiene and Tropical Medicine, London, England, UK.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Buckley', 'Affiliation': 'School of Social Sciences, Cardiff University, Cardiff, Wales, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Lohan', 'Affiliation': ""School of Nursing & Midwifery and Centre for Evidence and Social Innovation, Queen's University Belfast, Belfast, Northern Ireland, UK.""}]",Reproductive health,['10.1186/s12978-020-00975-y'] 1277,32856189,Lean-seafood intake increases urinary iodine concentrations and plasma selenium levels: a randomized controlled trial with crossover design.,"PURPOSE Iodine deficiency due to insufficient nutritional intake is a public health challenge in several European countries, including Norway. Lean-seafood has a high iodine and arsenic (As) content and is a good source of selenium (Se). Evidence of a direct effect of increased intake of lean-seafood on iodine status is limited. The main aims were to determine the iodine status at baseline and to investigate possible dietary effects on urinary iodine concentration (UIC) after intervention with lean-seafood versus non-seafood. Plasma Se, and plasma and urinary As concentrations were also measured. METHODS A randomized controlled crossover study comprising two 4 weeks experimental periods with two balanced diets varied in main proteins (60% of total dietary proteins) of lean-seafood and non-seafood, separated by a 5 week washout period. RESULTS Twenty participants (7 males, 13 females) were included and the mean ± SD age was 50.6 ± 15.3 years for all participants. Fasting UIC was median (25th, 75th percentile) 70 (38, 110) and 79 (49, 94) µg/L in the lean-seafood and non-seafood intervention at baseline, respectively. UIC increased after 4 weeks of the lean-seafood intervention to 135 (110, 278) µg/L, but not after the non-seafood intervention [58 (33, 91) µg/L] (P diet-effect < 0.001). Fasting plasma Se increased in the lean-seafood intervention and decreased in the non-seafood intervention (P diet-effect = 0.001). Fasting urinary and plasma As increased in the lean-seafood intervention and was unchanged in the non-seafood intervention (P diet-effect < 0.001). CONCLUSION The participant's UIC was below the recommended median (100 µg/L) at baseline, but increased sufficiently after a 4 week intervention with lean-seafood.",2021,Fasting plasma Se increased in the lean-seafood intervention and decreased in the non-seafood intervention (P diet-effect = 0.001).,"['two 4\xa0weeks experimental periods with two balanced diets varied in main proteins (60% of total dietary proteins) of lean-seafood and non-seafood, separated by a 5\xa0week washout period', 'Twenty participants (7 males, 13 females) were included and the mean\u2009±\u2009SD age was 50.6\u2009±\u200915.3\xa0years for all participants']","['Lean-seafood intake', 'lean-seafood versus non-seafood']","['UIC', 'Fasting UIC', 'Fasting plasma Se', 'Plasma Se, and plasma and urinary', 'urinary iodine concentration (UIC', 'urinary iodine concentrations and plasma selenium levels', 'Fasting urinary and plasma']","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0452410', 'cui_str': 'Balanced diet'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0439175', 'cui_str': '% of total'}, {'cui': 'C0012177', 'cui_str': 'Proteins, Dietary'}, {'cui': 'C0206208', 'cui_str': 'Seafood'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517578', 'cui_str': '15.3'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0559272', 'cui_str': 'Seafood intake'}, {'cui': 'C0206208', 'cui_str': 'Seafood'}]","[{'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0858169', 'cui_str': 'Plasma selenium'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0322473,Fasting plasma Se increased in the lean-seafood intervention and decreased in the non-seafood intervention (P diet-effect = 0.001).,"[{'ForeName': 'Jannike', 'Initials': 'J', 'LastName': 'Øyen', 'Affiliation': 'Institute of Marine Research, P.O. Box 1870 Nordnes, 5817, Bergen, Norway. jannike.oyen@hi.no.'}, {'ForeName': 'Eli Kristin', 'Initials': 'EK', 'LastName': 'Aadland', 'Affiliation': 'Institute of Marine Research, P.O. Box 1870 Nordnes, 5817, Bergen, Norway.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Liaset', 'Affiliation': 'Institute of Marine Research, P.O. Box 1870 Nordnes, 5817, Bergen, Norway.'}, {'ForeName': 'Even', 'Initials': 'E', 'LastName': 'Fjære', 'Affiliation': 'Institute of Marine Research, P.O. Box 1870 Nordnes, 5817, Bergen, Norway.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Dahl', 'Affiliation': 'Institute of Marine Research, P.O. Box 1870 Nordnes, 5817, Bergen, Norway.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Madsen', 'Affiliation': 'Institute of Marine Research, P.O. Box 1870 Nordnes, 5817, Bergen, Norway.'}]",European journal of nutrition,['10.1007/s00394-020-02366-2'] 1278,32857315,"Single-Dose Pharmacokinetics of Ozanimod and its Major Active Metabolites Alone and in Combination with Gemfibrozil, Itraconazole, or Rifampin in Healthy Subjects: A Randomized, Parallel-Group, Open-Label Study.","INTRODUCTION The aims of this study were to characterize the single-dose pharmacokinetics (PK) of the major active metabolites of ozanimod, CC112273 and CC1084037, and to evaluate the effect of gemfibrozil (a strong inhibitor of cytochrome P450 [CYP] 2C8), itraconazole (a strong inhibitor of CYP3A and P-glycoprotein [P-gp]), and rifampin (a strong inducer of CYP3A/P-gp and moderate inducer of CYP2C8) on the single-dose PK of ozanimod and its major active metabolites in healthy subjects. METHODS This was a phase 1, randomized, parallel-group, open-label study with two parts. In part 1, 40 subjects were randomized to receive a single oral dose of ozanimod 0.46 mg (group A, n = 20) or oral doses of gemfibrozil 600 mg twice daily for 17 days with a single oral dose of ozanimod 0.46 mg on day 4 (group B, n = 20). In part 2, 60 subjects were randomized to receive a single oral dose of ozanimod 0.92 mg (group C, n = 20), oral doses of itraconazole 200 mg once daily for 17 days with a single oral dose of ozanimod 0.92 mg on day 4 (group D, n = 20), or oral doses of rifampin 600 mg once daily for 21 days with a single oral dose of ozanimod 0.92 mg on day 8 (group E, n = 20). Plasma PK parameters for ozanimod, CC112273, and CC1084037 were estimated using noncompartmental methods. RESULTS Dose-proportional increases in maximum observed concentration (C max ) and area under the concentration-time curve (AUC) were observed for ozanimod, CC112273, and CC1084037. The mean terminal elimination half-life (t 1/2 ) for ozanimod was approximately 20-22 h while the mean t 1/2 for CC112273 and CC1084037 were approximately 10 days. CC112273 and CC1084037 exposures were highly correlated with or without interacting drugs. Itraconazole increased ozanimod AUC by approximately 13% while rifampin reduced ozanimod AUC by approximately 24%, suggesting a minor role of CYP3A and P-gp in the overall disposition of ozanimod. Gemfibrozil increased the AUC for CC112273 and CC1084037 by approximately 47% and 69%, respectively. Rifampin reduced the AUC for CC112273 and CC1084037, primarily via CYP2C8 induction, by approximately 60% and 55%, respectively. CONCLUSIONS Ozanimod's major active metabolites, CC112273 and CC1084037, exhibited similar single-dose PK properties and their exposures were highly correlated. CYP2C8 is one of the important enzymes in the overall disposition of CC112273 and subsequently its direct metabolite CC1084037. TRIAL REGISTRATION Clinical trial: NCT03624959.",2020,"Rifampin reduced the AUC for CC112273 and CC1084037, primarily via CYP2C8 induction, by approximately 60% and 55%, respectively. ","['In part\xa02, 60 subjects', '40 subjects', 'healthy subjects', 'Healthy Subjects']","['itraconazole', 'ozanimod 0.46\xa0mg (group\xa0A, n\u2009=\u200920) or oral doses of gemfibrozil 600\xa0mg twice daily for 17\xa0days with a single oral dose of ozanimod 0.46\xa0mg on day\xa04', 'Ozanimod', 'Itraconazole', 'ozanimod', 'gemfibrozil', 'rifampin 600\xa0mg once daily for 21\xa0days with a single oral dose of ozanimod 0.92', 'Gemfibrozil', 'Gemfibrozil, Itraconazole, or Rifampin', 'ozanimod 0.92']","['Plasma PK parameters', 'ozanimod AUC', 'maximum observed concentration (C max ) and area under the concentration-time curve (AUC', 'mean terminal elimination half-life', 'AUC']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C4278675', 'cui_str': 'ozanimod'}, {'cui': 'C4517460', 'cui_str': '0.46'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0993358', 'cui_str': 'Gemfibrozil 600 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0017245', 'cui_str': 'Gemfibrozil'}, {'cui': 'C1104996', 'cui_str': 'Rifampin 600 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C4517485', 'cui_str': '0.92'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4278675', 'cui_str': 'ozanimod'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}]",40.0,0.103499,"Rifampin reduced the AUC for CC112273 and CC1084037, primarily via CYP2C8 induction, by approximately 60% and 55%, respectively. ","[{'ForeName': 'Jonathan Q', 'Initials': 'JQ', 'LastName': 'Tran', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics and Research and Early Development, Bristol-Myers Squibb Company, Princeton, NJ, USA. dr.jtran@gmail.com.'}, {'ForeName': 'Peijin', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics and Research and Early Development, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}, {'ForeName': 'Atalanta', 'Initials': 'A', 'LastName': 'Ghosh', 'Affiliation': 'Biometrics and Data Science, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}, {'ForeName': 'Liangang', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Biometrics and Data Science, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Syto', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics and Research and Early Development, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Bristol-Myers Squibb Company, Nonclinical Research and Development, Princeton, NJ, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Palmisano', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics and Research and Early Development, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}]",Advances in therapy,['10.1007/s12325-020-01473-0'] 1279,32830383,Skin-cleaning among hospitalized people who inject drugs: a randomized controlled trial.,"AIMS To test the hypothesis that among hospitalized people who inject drugs (PWID), a brief intervention in skin-cleaning would result in greater reductions in follow-up emergency department (ED) or hospitalization rates compared with a usual care condition. DESIGN Randomized, two-group (intervention, n = 128; usual care, n = 124), single-site clinical trial with12-month follow-up. SETTING Hospital inpatient services in Boston, Massachusetts, United States. PARTICIPANTS People who injected drugs on at least 3 days each week prior to hospital admission (n = 252). Participants averaged 37.9 (± 10.7) years of age; 58.5% were male, 59.3% were white and 61.1% had a diagnosis related to skin infection at enrollment. INTERVENTION AND COMPARATOR Intervention was a skin hygiene education and skills-training behavioral intervention [short-term efficacy data on a behavioral intervention (SKIN)] consisting of two education- and skills-based skin-cleaning sessions, one during hospitalization and another 4 weeks later. The comparator was treatment as usual: an informational brochure about substance use treatment options and needle exchange programs in the area and follow-up clinical appointments as arranged by the inpatient medical staff. MEASUREMENTS Electronic medical records were reviewed and discharge diagnoses for each ED visit and hospital admission were categorized into injection-related bacterial events (e.g. cellulitis) and non-injection-related events. Negative binomial regression was used to test the intervention effects for the primary outcome and total ED visits, as well as the secondary outcomes, total number of hospitalizations, injection drug use-related (IDU-related) ED visits and IDU-related hospitalizations. We also tested whether the outcomes were moderated by whether the initial hospitalization was IDU-related. FINDINGS Of people assigned to SKIN, 66 completed two sessions, 55 completed one session and seven completed zero sessions. Adjusting for baseline covariates, the mean rate of total ED visits in the next 12 months was non-significantly higher [incidence rate ratio (IRR) = 1.13, 95% confidence interval (CI) = 0.96, 1.33, P = 0.152] compared with usual treatment. The intervention did not significantly reduce total hospitalizations or IDU-related hospitalizations. Adjusting for baseline covariates, the mean rate of injection drug use-related ED visits in the next 12 months was lower (IRR = 0.57, 95% CI = 0.35, 0.91, P = 0.019) compared with treatment as usual. CONCLUSIONS A skin-cleaning intervention for people who inject drugs delivered during a hospitalization did not significantly reduce either overall emergency department use or hospitalization. There was some evidence that it may have reduced injection drug use-related emergency department visits.",2021,"CONCLUSIONS A skin-cleaning intervention for people who inject drugs delivered during a hospitalization did not significantly reduce either overall emergency department use or hospitalization.","['n=128; usual care, n=124), single site clinical trial with12-month follow-up', 'hospitalized people who inject drugs (PWID', 'Hospitalized Persons', 'Hospital inpatient services in Boston, Massachusetts, USA.\nPARTICIPANTS\n\n\nPersons who injected drugs on at least 3 days each week prior to hospital admission (n=252', 'Participants averaged 37.9 (± 10.7) years of age, 58.5% were male, 59.3% were white, and 61.1% had a diagnosis related to skin infection at enrollment']","['Inject Drugs', 'Skin Cleaning', 'SKIN', 'skin hygiene education and skills-training behavioral intervention (SKIN) consisting of two education and skills-based skin-cleaning sessions', 'skin-cleaning intervention', 'informational brochure about substance use treatment options and needle exchange programs']","['discharge diagnoses for each ED visit and hospital admission were categorized into injection-related bacterial events (e.g., cellulitis) and non-injection-related events', 'total hospitalizations or IDU-related hospitalisations', 'mean rate of total ED visits', 'mean rate of injection drug use related ED visits', 'total ED visits, as well as the secondary outcomes, total number of hospitalizations, injection drug use related (IDU-related) ED visits, and IDU-related hospitalizations', 'overall emergency department use or hospitalization']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0239966', 'cui_str': 'Hospital patient'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C5191365', 'cui_str': '10.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0007642', 'cui_str': 'Cellulitis'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}]","[{'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C1286234', 'cui_str': 'Skin hygiene'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0574729', 'cui_str': 'Skin clean'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0150359', 'cui_str': 'Substance use therapy'}, {'cui': 'C0242883', 'cui_str': 'Syringe-Exchange Programs'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0007642', 'cui_str': 'Cellulitis'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0020811', 'cui_str': 'Idoxuridine'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.061035,"CONCLUSIONS A skin-cleaning intervention for people who inject drugs delivered during a hospitalization did not significantly reduce either overall emergency department use or hospitalization.","[{'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Stein', 'Affiliation': 'Behavioral Medicine and Addictions Research, Butler Hospital, Providence, RI, USA.'}, {'ForeName': 'Kristina T', 'Initials': 'KT', 'LastName': 'Phillips', 'Affiliation': 'Center for Integrated Health Care Research, Kaiser Permanente Hawaii, Honolulu, HI, USA.'}, {'ForeName': 'Debra S', 'Initials': 'DS', 'LastName': 'Herman', 'Affiliation': 'Behavioral Medicine and Addictions Research, Butler Hospital, Providence, RI, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Keosaian', 'Affiliation': 'Boston University School of Public Health, Boston, MA,, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Stewart', 'Affiliation': 'Boston University School of Public Health, Boston, MA,, USA.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Anderson', 'Affiliation': 'Behavioral Medicine and Addictions Research, Butler Hospital, Providence, RI, USA.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Weinstein', 'Affiliation': 'Section of General Internal Medicine, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Liebschutz', 'Affiliation': 'Division of General Internal Medicine, Center for Research on Health Care, University of Pittsburgh, Pittsburgh, PA, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15236'] 1280,32840955,Video cognitive-behavioral therapy for insomnia in cancer patients: A cost-effective alternative.,"OBJECTIVE Despite its high prevalence, cancer-related insomnia typically remains untreated because of a lack of access to cognitive-behavioral therapy for insomnia (CBT-I), the treatment of choice for this condition. While face-to-face CBT-I appears to be optimal in terms of efficacy, self-administered formats may be more cost-effective. The goal of this secondary analysis of a randomized clinical trial was to compare the cost-effectiveness of a professionally-based CBT-I (PCBT-I) to that of a video-based CBT-I (VCBT-I). METHODS A total of 161 women with breast cancer received six weekly, individual CBT-I sessions (PCBT-I; n = 81) or a 60-minutes animated video +6 short booklets (VCBT-I; n = 80). Participants completed the Insomnia Severity Index (ISI) and provided information to calculate treatment costs. RESULTS Total per patient treatment costs were 5.5 times greater for PCBT-I ($1298.90) than VCBT-I ($234.36; P < .0001). Both at posttreatment and 3-month follow-up, the ISI reduction was greater in PCBT-I than VCBT-I, but these differences were not significant (P = .09 and P = .24, respectively). In contrast, the cost-effectiveness ratio was significantly more advantageous for VCBT-I than PCBT-I. Compared to VCBT-I, each reduction of 1 unit on the ISI produced by PCBT-I was associated with a treatment cost that was significantly greater at posttreatment ($186.95 CAD vs $44.87 CAD; P = .001) and follow-up ($154.76 vs $24.97, P = .005). CONCLUSIONS Although CBT-I is slightly less efficacious when self-administered, it constitutes a much more cost-effective alternative than face-to-face CBT-I and represents an extremely valuable option in settings where monetary and human resources required to administer CBT-I are not available or sufficient.",2021,"Both at posttreatment and 3-month follow-up, the ISI reduction was greater in PCBT","['161 women with breast cancer', 'Cancer Patients ']","['individual CBT-I sessions (PCBT-I; n =\u200981) or a 60-min animated video + 6 short booklets', 'professionally-based CBT-I (PCBT-I', 'PCBT', 'Video Cognitive-Behavioral Therapy', 'video-based CBT-I (VCBT-I']","['Insomnia Severity Index (ISI', 'cost-effectiveness', 'cost-effectiveness ratio', 'ISI reduction']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",161.0,0.0324276,"Both at posttreatment and 3-month follow-up, the ISI reduction was greater in PCBT","[{'ForeName': 'Josée', 'Initials': 'J', 'LastName': 'Savard', 'Affiliation': 'School of Psychology, Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Ivers', 'Affiliation': 'School of Psychology, Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Morin', 'Affiliation': 'School of Psychology, Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Lacroix', 'Affiliation': 'Department of Economics, Université Laval, Quebec City, Quebec, Canada.'}]",Psycho-oncology,['10.1002/pon.5532'] 1281,32854000,Abstinence-reinforcing contingency management improves HIV viral load suppression among HIV-infected people who use drugs: A randomized controlled trial.,"BACKGROUND HIV-infected people who use drugs (PWUD) have poor HIV outcomes. Few studies tested interventions to improve HIV outcomes among PWUD. Abstinence-reinforcing contingency management (CM) reduces drug use and could also improve HIV outcomes. METHODS From 2012-2017, we conducted a randomized controlled trial testing whether a 16-week abstinence-reinforcing CM intervention improved HIV viral load (VL) among HIV-infected adults using opioids or cocaine. In the CM intervention, drug-free urines led to escalating value of vouchers ($2.50-$80/voucher, $1320 total maximum). In intention-to-treat mixed-effects linear and logistic regression analyses, we examined whether the CM intervention improved log 10 VL (primary outcome), abstinence and antiretroviral adherence (secondary outcomes). RESULTS Thirty-seven participants were randomized to the CM intervention and 36 to control. Median age was 49.2 years; most were male (61.6%) and non-Hispanic black (46.6%). In CM (vs. control) participants, mean reduction in log 10 VL was greater (-0.16 log 10 VL copies/mL per 4-week period; 95% CI: -0.29 to -0.03, p < 0.05). Over 16 weeks, CM participants had a mean reduction of 0.64 copies/mL in log 10 VL greater than control participants. The CM intervention was not significantly associated with abstinence or adherence. CONCLUSIONS This is the first study to demonstrate improvements in HIV VL via an abstinence-reinforcing CM intervention. Because the CM intervention did not significantly affect abstinence or adherence, the mechanism of its effect is unclear. To end the HIV epidemic, innovative strategies must address individuals with poor HIV outcomes. Abstinence-reinforcing CM may be one potential strategy to improve HIV outcomes among a select group of PWUD.",2020,"Over 16 weeks, CM participants had a mean reduction of 0.64 copies/mL in log 10 VL greater than control participants.","['From 2012-2017', 'HIV-infected people who use drugs', 'Thirty-seven participants', 'HIV-infected adults using', 'Median age was 49.2 years; most were male (61.6%) and non-Hispanic black (46.6']","['opioids or cocaine', 'Abstinence-reinforcing contingency management (CM', 'CM intervention', 'abstinence-reinforcing CM intervention', 'Abstinence-reinforcing contingency management']","['mean reduction in log 10 VL', 'log 10 VL (primary outcome), abstinence and antiretroviral adherence (secondary outcomes', 'HIV viral load suppression', 'HIV outcomes', 'HIV viral load (VL', 'abstinence or adherence']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",37.0,0.178726,"Over 16 weeks, CM participants had a mean reduction of 0.64 copies/mL in log 10 VL greater than control participants.","[{'ForeName': 'Chinazo O', 'Initials': 'CO', 'LastName': 'Cunningham', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States. Electronic address: ccunning@montefiore.org.'}, {'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'Arnsten', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Chenshu', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Moonseong', 'Initials': 'M', 'LastName': 'Heo', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States; Clemson University College of Behavioral, Social and Health Sciences, Department of Public Health Sciences, Clemson Nursing Building, 605 Grove Road, Greenville, SC 29605, United States.'}, {'ForeName': 'Marcus A', 'Initials': 'MA', 'LastName': 'Bachhuber', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States; Lousiana State University Health Sciences Center-New Orleans, Section of Community and Population Medicine, Department of Medicine, 533 Bolivar St, New Orleans, LA 70112, United States.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Jost', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Grossberg', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Stein', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Sohler', 'Affiliation': 'City University of New York, School of Medicine, 160 Convent Ave, New York, NY 10031, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108230'] 1282,32845449,Artificial endocrine pancreas with a closed-loop system effectively suppresses the accelerated hyperglycemic status after reperfusion during aortic surgery.,"OBJECTIVES To control intraoperative hyperglycemia in patients who underwent aortic surgery using STG-55 ® artificial endocrine pancreas and clarify the effectiveness of this device. METHODS Blood glucose control using the STG-55 ® was performed in 18 patients (15 men and 3 women; age, 66 ± 10 years) who required hypothermic circulatory arrest (STG-55 ® group). Seventeen patients (10 men and 7 women; age, 71 ± 8 years) whose blood glucose was controlled using the conventional method were included in the control group. Glucose concentration was controlled with the aim of maintaining it at 150 mg/dl. RESULTS In both groups, the blood glucose concentrations did not significantly change during the interruption of systemic perfusion; however, a sharp increase was noted immediately after reperfusion. Although the hyperglycemic status persisted after reperfusion in the control group, it was effectively suppressed in the STG-55 ® group (STG ® vs. control group at 50 min after reperfusion: 180 ± 35 vs. 212 ± 47 mg/dl, p = 0.026) and blood glucose concentration reached the target value of 150 mg/dl at 100 min after reperfusion (STG ® vs. control group: 153 ± 29 vs. 215 ± 43 mg/dl, p = 0.0008). The total administered insulin dose was 175 ± 81 U and 5 ± 3 U in the STG ® and control groups, respectively (p < 0.0001). CONCLUSIONS To treat the accelerated hyperglycemic status in aortic surgery requiring circulatory arrest, strict glycemic control using an artificial endocrine pancreas might be beneficial.",2021,"In both groups, the blood glucose concentrations did not significantly change during the interruption of systemic perfusion; however, a sharp increase was noted immediately after reperfusion.","['18 patients (15 men and 3 women; age, 66\u2009±\u200910\xa0years) who required hypothermic circulatory arrest (STG-55 ® group', 'patients who underwent aortic surgery using STG-55 ® artificial endocrine pancreas', 'Seventeen patients (10 men and 7 women; age, 71\u2009±\u20098\xa0years) whose blood glucose was controlled using the conventional method were included in the control group']",['STG-55 ®'],"['Glucose concentration', 'blood glucose concentration', 'hyperglycemic status', 'accelerated hyperglycemic status', 'blood glucose concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0444720', 'cui_str': 'Circulatory arrest'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0877130', 'cui_str': 'Aortic surgery'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0771711', 'cui_str': 'Pancreas extract'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}]",18.0,0.0213292,"In both groups, the blood glucose concentrations did not significantly change during the interruption of systemic perfusion; however, a sharp increase was noted immediately after reperfusion.","[{'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Aizawa', 'Affiliation': 'Department of Cardiovascular Surgery, Jichi Medical School, Jichi Medical University, Yakushiji 3311-1, Shimotsuke, Tochigi, 329-0498, Japan. tcvai@jichi.ac.jp.'}, {'ForeName': 'Arata', 'Initials': 'A', 'LastName': 'Muraoka', 'Affiliation': 'Department of Cardiovascular Surgery, Jichi Medical School, Jichi Medical University, Yakushiji 3311-1, Shimotsuke, Tochigi, 329-0498, Japan.'}, {'ForeName': 'Soki', 'Initials': 'S', 'LastName': 'Kurumisawa', 'Affiliation': 'Department of Cardiovascular Surgery, Jichi Medical School, Jichi Medical University, Yakushiji 3311-1, Shimotsuke, Tochigi, 329-0498, Japan.'}, {'ForeName': 'Hirohiko', 'Initials': 'H', 'LastName': 'Akutsu', 'Affiliation': 'Department of Cardiovascular Surgery, Jichi Medical School, Jichi Medical University, Yakushiji 3311-1, Shimotsuke, Tochigi, 329-0498, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Sugaya', 'Affiliation': 'Department of Cardiovascular Surgery, Jichi Medical School, Jichi Medical University, Yakushiji 3311-1, Shimotsuke, Tochigi, 329-0498, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Uesugi', 'Affiliation': 'Department of Cardiovascular Surgery, Jichi Medical School, Jichi Medical University, Yakushiji 3311-1, Shimotsuke, Tochigi, 329-0498, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Kawahito', 'Affiliation': 'Department of Cardiovascular Surgery, Jichi Medical School, Jichi Medical University, Yakushiji 3311-1, Shimotsuke, Tochigi, 329-0498, Japan.'}]",General thoracic and cardiovascular surgery,['10.1007/s11748-020-01415-1'] 1283,32860075,Risk of relapse after anti-PD1 discontinuation in patients with Hodgkin lymphoma.,"INTRODUCTION Patients with relapsed/refractory Hodgkin lymphoma (R/R HL) experience high response rates upon anti-PD1 therapy. In these patients, the optimal duration of treatment and the risk of relapse after anti-PD1 discontinuation are unknown. METHODS We retrospectively analyzed patients with R/R HL who responded to anti-PD1 monotherapy and discontinued the treatment either because of unacceptable toxicity or prolonged remission. A machine learning algorithm based on 17 candidate variables was trained and validated to predict progression-free survival (PFS) landmarked at the time of discontinuation of anti-PD1 therapy. RESULTS Forty patients from 14 centers were randomly assigned to training (n = 25) and validation (n = 15) sets. At the time of anti-PD1 discontinuation, patients had received treatment for a median duration of 11.2 (range, 0-time to best response was not statistically significant in discriminating patients with PFS lesser or greater than 12 months). Considering PFS status as a binary variable (alive or dead) at a specific time point (12 months) is convenient, intuitive and allows for comparing the value of potential predicting variables in these two groups of patients. Nonetheless, this approach has two drawbacks: first, it binarizes outcome; second, it excludes patients alive with a time to last follow up lesser 12 months. Therefore, it is less powerful to demonstrate statistically significant association with PFS even if it exists 5 months. Patients discontinued anti-PD1 treatment either because of prolonged remission (N = 27, 67.5%) or unacceptable toxicity (N = 13, 32.5%). Most patients were in CR (N = 35, 87.5%) at the time of anti-PD1 discontinuation. In the training set, the machine learning algorithm identified that the most important variables to predict PFS were patients' age, time to best response, and presence or absence of CR. The performance observed in the training set was validated in the validation set. CONCLUSION In this pilot, proof of concept study using a machine learning algorithm, we identified biomarkers capable of predicting the risk of relapse after anti-PD1 discontinuation (age, time to best response, quality of response). Once confirmed, these simple biomarkers will represent useful tools to guide the management of these patients.",2021,"Most patients were in CR (N = 35, 87.5%) at the time of anti-PD1 discontinuation.","['patients with Hodgkin lymphoma', 'Forty patients from 14 centers']",['machine learning algorithm'],"['unacceptable toxicity or prolonged remission', 'unacceptable toxicity', 'prolonged remission', 'Risk of relapse']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019829', 'cui_str': 'Hodgkin lymphoma'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",40.0,0.0215256,"Most patients were in CR (N = 35, 87.5%) at the time of anti-PD1 discontinuation.","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Manson', 'Affiliation': 'Department of Hematology, University Hospital of Rennes, 2 rue Henri Le Guilloux, 35033, Rennes Cedex 9, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Brice', 'Affiliation': 'Department of Hematology, Saint-Louis Hospital, AP-HP, Paris, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Herbaux', 'Affiliation': 'Department of Hematology, University Hospital of Lille, Lille, France.'}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Silva', 'Affiliation': 'Department of Hematology, Instituto Português de Oncologia de Lisboa, Lisbon, Portugal.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Bouabdallah', 'Affiliation': 'Department of Hematology, University Hospital of Bordeaux, F-33000, Bordeaux, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Deau', 'Affiliation': 'Department of Hematology, Cochin Hospital, AP-HP, Paris, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bouteloup', 'Affiliation': 'Department of Hematology, Chalon Hospital, Chalon-sur-Saone, France.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Schiano', 'Affiliation': 'Department of Hematology, Paoli-Calmettes Institute, Marseille, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Nicolas-Virelizier', 'Affiliation': 'Department of Hematology, Leon Berard Center, Lyon, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Maerevoet', 'Affiliation': 'Institut Bordet, Université Libre de Bruxelles, Bruxelles, Belgium.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Ghesquieres', 'Affiliation': 'Department of Hematology, University Hospital of Lyon, Lyon, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Stamatoullas', 'Affiliation': 'Department of Hematology,, Centre Henri Becquerel, Rouen, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Antier', 'Affiliation': 'Department of Hematology, Nantes University Hospital, Nantes, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Carlo-Stella', 'Affiliation': 'Department of Oncology and Hematology, Humanitas Clinical and Research Center - IRCCS, Rozzano, MI, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'de Charette', 'Affiliation': 'Department of Hematology, University Hospital of Lille, Lille, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Poizeau', 'Affiliation': 'Department of Dermatology, Rennes University Hospital, Rennes, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Dercle', 'Affiliation': 'UMR1015, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Roch', 'Initials': 'R', 'LastName': 'Houot', 'Affiliation': 'Department of Hematology, University Hospital of Rennes, 2 rue Henri Le Guilloux, 35033, Rennes Cedex 9, France. roch.houot@chu-rennes.fr.'}]",European journal of nuclear medicine and molecular imaging,['10.1007/s00259-020-05015-2'] 1284,32842825,A low dose of lysergic acid diethylamide decreases pain perception in healthy volunteers.,"BACKGROUND Lysergic acid diethylamide (LSD) is an ergot alkaloid derivative with psychedelic properties that has been implicated in the management of persistent pain. Clinical studies in the 1960s and 1970s have demonstrated profound analgesic effects of full doses of LSD in terminally ill patients, but this line of research evaporated after LSD was scheduled worldwide. AIM The present clinical study is the first to revisit the potential of LSD as an analgesic, and at dose levels which are not expected to produce profound mind-altering effects. METHODS Twenty-four healthy volunteers received single doses of 5, 10 and 20 µg LSD as well as placebo on separate occasions. A Cold Pressor Test was administered at 1.5 and 5 h after treatment administration to assess pain tolerance to experimentally evoked pain. Ratings of dissociation and psychiatric symptoms as well as assessments of vital signs were included to monitor mental status as well as safety during treatments. RESULTS LSD 20 µg significantly increased the time that participants were able to tolerate exposure to cold (3°C) water and decreased their subjective levels of experienced pain and unpleasantness. LSD elevated mean blood pressure within the normal range and slightly increased ratings of dissociation, anxiety and somatization. CONCLUSION The present study provides evidence of a protracted analgesic effect of LSD at a dose that is low enough to avoid a psychedelic experience. The present data warrant further research into the analgesic effects of low doses of LSD in patient populations.",2021,"RESULTS LSD 20 µg significantly increased the time that participants were able to tolerate exposure to cold (3°C) water and decreased their subjective levels of experienced pain and unpleasantness.","['healthy volunteers', 'Twenty-four healthy volunteers']","['Lysergic acid diethylamide (LSD', 'placebo', 'LSD', 'lysergic acid diethylamide']","['Ratings of dissociation and psychiatric symptoms', 'subjective levels of experienced pain and unpleasantness', 'pain tolerance', 'ratings of dissociation, anxiety and somatization', 'LSD elevated mean blood pressure', 'pain perception']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3715070', 'cui_str': '24'}]","[{'cui': 'C0024334', 'cui_str': 'Lysergic acid diethylamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0086168', 'cui_str': 'Dissociation - mental defense mechanism'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0024334', 'cui_str': 'Lysergic acid diethylamide'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",24.0,0.113171,"RESULTS LSD 20 µg significantly increased the time that participants were able to tolerate exposure to cold (3°C) water and decreased their subjective levels of experienced pain and unpleasantness.","[{'ForeName': 'Johannes G', 'Initials': 'JG', 'LastName': 'Ramaekers', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Hutten', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Natasha L', 'Initials': 'NL', 'LastName': 'Mason', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Dolder', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Eef L', 'Initials': 'EL', 'LastName': 'Theunissen', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Holze', 'Affiliation': 'Division of Clinical Pharmacology and Toxicology, Department of Biomedicine and Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Matthias E', 'Initials': 'ME', 'LastName': 'Liechti', 'Affiliation': 'Division of Clinical Pharmacology and Toxicology, Department of Biomedicine and Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Feilding', 'Affiliation': 'The Beckley Foundation, Beckley Park, Oxford, UK.'}, {'ForeName': 'Kim Pc', 'Initials': 'KP', 'LastName': 'Kuypers', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, Maastricht, the Netherlands.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120940937'] 1285,32845388,Nomogram based on radiomics analysis of primary breast cancer ultrasound images: prediction of axillary lymph node tumor burden in patients.,"OBJECTIVES To establish a prediction model for evaluating the axillary lymph node (ALN) status of patients with T1/T2 invasive breast cancer based on radiomics analysis of US images of primary breast lesions. METHODS Between August 2016 and November 2018, a total of 343 patients with histologically proven malignant breast tumors were included in this study and randomly assigned to the training and validation groups at a ratio of 7:3. ALN tumor burden was defined as low (< 3 metastatic ALNs) or high (≥ 3 metastatic ALNs). Radiomics features were obtained using the PyRadiomics package, and the radiomics score was established by least absolute shrinkage and selection operator regression. A nomogram combining the breast cancer US radiomics score with patient age and lesion size was generated based on the multivariate logistic regression results. RESULTS In the training and validation cohorts, 29.1% (69/237) and 32.08% (34/106) of patients were pathologically diagnosed with more than 2 metastatic ALNs, respectively. The radiomics score consisted of 16 US features, and patient age and lesion diameter identified by US were included to construct the model. The AUC of the model was 0.846 (95% CI, 0.790-0.902) for the training cohort and 0.733 (95% CI, 0.613-0.852) for the validation cohort. The calibration curves showed good agreement between the predictions and observations. CONCLUSIONS Our novel nomogram demonstrates high accuracy in predicting ALN tumor burden in breast cancer patients. We also suggest further development of PyRadiomics to improve US radiomics. KEY POINTS • A nomogram based on US was developed to predict ALN tumor burden (low, < 3 metastatic ALNs; high, ≥ 3 metastatic ALNs). • The nomogram could assist clinicians in evaluating treatment strategies for T1/T2 invasive breast cancer.",2021,ALN tumor burden was defined as low (< 3 metastatic ALNs) or high (≥ 3 metastatic ALNs).,"['patients with T1/T2 invasive breast cancer based on radiomics analysis of US images of primary breast lesions', 'T1/T2 invasive breast cancer', 'patients', 'Between August 2016 and November 2018, a total of 343 patients with histologically proven malignant breast tumors', 'breast cancer patients']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0853879', 'cui_str': 'Invasive carcinoma of breast'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0567489', 'cui_str': 'Lesion of breast'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]",[],[],343.0,0.0327149,ALN tumor burden was defined as low (< 3 metastatic ALNs) or high (≥ 3 metastatic ALNs).,"[{'ForeName': 'Yuanjing', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Ultrasound, Chinese Academy of Medical Sciences and Peking Union Medical College Hospital, Shuaifuyuan 1st, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Yanwen', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Ultrasound, Chinese Academy of Medical Sciences and Peking Union Medical College Hospital, Shuaifuyuan 1st, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Chenyang', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'Department of Ultrasound, Chinese Academy of Medical Sciences and Peking Union Medical College Hospital, Shuaifuyuan 1st, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Mengsu', 'Initials': 'M', 'LastName': 'Xiao', 'Affiliation': 'Department of Ultrasound, Chinese Academy of Medical Sciences and Peking Union Medical College Hospital, Shuaifuyuan 1st, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Department of Ultrasound, Chinese Academy of Medical Sciences and Peking Union Medical College Hospital, Shuaifuyuan 1st, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Ultrasound, Chinese Academy of Medical Sciences and Peking Union Medical College Hospital, Shuaifuyuan 1st, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Qin', 'Affiliation': 'Department of Ultrasound, Chinese Academy of Medical Sciences and Peking Union Medical College Hospital, Shuaifuyuan 1st, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Qingli', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': 'Department of Ultrasound, Chinese Academy of Medical Sciences and Peking Union Medical College Hospital, Shuaifuyuan 1st, Dongcheng District, Beijing, 100730, China. zqlpumch@126.com.'}, {'ForeName': 'Yuxin', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Ultrasound, Chinese Academy of Medical Sciences and Peking Union Medical College Hospital, Shuaifuyuan 1st, Dongcheng District, Beijing, 100730, China. yuxinjiangxh@163.com.'}]",European radiology,['10.1007/s00330-020-07181-1'] 1286,32859445,Comparison of effects of baby shampoo vs. saline irrigation on endoscopic sinus surgery outcomes and quality of life.,"OBJECTIVE Nasal irrigation is an important step of functional endoscopic sinus surgery (FESS) postoperative care. This study was performed to compare the effects of diluted baby shampoo (BS) and normal saline solution (NSS) irrigation on patients' quality of life (QoL) and surgical outcomes after FESS. METHODS This study included 77 patients who underwent FESS to treat chronic rhinosinusitis with nasal polyps. Lund-Mackay score, Lund-Kennedy endoscopic score (LKES), synechia score and QoL (using the Sinonasal Outcome Test (SNOT-22)) were evaluated. RESULTS LKES was significantly better in the BS group (p=0.001), especially in terms of nasal discharge and crust formation (p=0.024 and p=0.030, respectively) at 1 month postoperatively. However, no significant difference was found at 3, 6 or 12 months postoperatively (p=0.833, p=0.263, and p=0.346, respectively). The reduction of SNOT-22 score (between preoperative assessment and 1 month postoperatively) was significantly better in the BS than in the NSS group (p=0.025). However, no statistically significant differences were found between groups at 3, 6, or 12 months postoperatively (p=0.312, p=0.280, and p=0.285, respectively). In the evaluation of SNOT-22 subdomains, changes in psychological, rhinological and extranasal rhinological subdomains were significantly better in the BS group at 1 month postoperatively (p=0.019, p=0.010 and p=0.002, respectively). CONCLUSION Compared to irrigation with NSS, BS usage following FESS led to reductions of crusting, nasal discharge and synechia formation; moreover, it was associated with improved SNOT-22 scores, especially in psychological, rhinological and extranasal rhinological subdomains.",2021,The reduction of SNOT-22 score (between preoperative assessment and 1 month postoperatively) was significantly better in the BS than in the NSS group (p=0.025).,['77 patients who underwent FESS to treat chronic rhinosinusitis with nasal polyps'],"['FESS', 'baby shampoo vs. saline irrigation', 'diluted baby shampoo (BS) and normal saline solution (NSS) irrigation']","['SNOT-22 scores', 'endoscopic sinus surgery outcomes and quality of life', 'Lund-Mackay score, Lund-Kennedy endoscopic score (LKES), synechia score and QoL (using the Sinonasal Outcome Test (SNOT-22', 'psychological, rhinological and extranasal rhinological subdomains', 'crusting, nasal discharge and synechia formation', 'nasal discharge and crust formation', ""patients' quality of life (QoL) and surgical outcomes"", 'reduction of SNOT-22 score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}]","[{'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0150765', 'cui_str': 'Shampoo'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C5197690', 'cui_str': 'SNOT-22'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0154933', 'cui_str': 'Adhesions of iris'}, {'cui': 'C5197689', 'cui_str': 'Sinonasal Outcome Test'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0205204', 'cui_str': 'Crust'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",77.0,0.0273264,The reduction of SNOT-22 score (between preoperative assessment and 1 month postoperatively) was significantly better in the BS than in the NSS group (p=0.025).,"[{'ForeName': 'Kamil Gokce', 'Initials': 'KG', 'LastName': 'Tulaci', 'Affiliation': 'Departments of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Balikesir University, Balikesir/Turkey. Electronic address: ktulaci@gmail.com.'}, {'ForeName': 'Erhan', 'Initials': 'E', 'LastName': 'Arslan', 'Affiliation': 'Departments of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Balikesir University, Balikesir/Turkey. Electronic address: drarslanerhan@hotmail.com.'}, {'ForeName': 'Tugba', 'Initials': 'T', 'LastName': 'Tulaci', 'Affiliation': 'Departments of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Balikesir University, Balikesir/Turkey. Electronic address: tugbatulaci@gmail.com.'}, {'ForeName': 'Hasmet', 'Initials': 'H', 'LastName': 'Yazici', 'Affiliation': 'Departments of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Balikesir University, Balikesir/Turkey. Electronic address: hsmtyzc@yahoo.com.tr.'}]","Auris, nasus, larynx",['10.1016/j.anl.2020.08.009'] 1287,32865325,Comparing the effects of CAD/CAM nickel-titanium lingual retainers on teeth stability and periodontal health with conventional fixed and removable retainers: A randomized clinical trial.,"OBJECTIVE The objectives of this study were to evaluate the effect of a CAD/CAM nickel-titanium retainer on the stability of mandibular anterior teeth and periodontal health and to compare it with other retainers. SETTING/SAMPLE POPULATION Sixty participants from both genders who had irregularities prior to orthodontic therapy and who had been treated with full-fixed appliance mechanotherapy were included in the study and randomly allocated into four groups: CAD/CAM NiTi, multi-stranded stainless steel, single-stranded nickel-free titanium and vacuum-formed removable retainer groups. The mean age of the participants at the end of the treatment was approximately 20 years. MATERIALS AND METHODS Digital impressions were taken for all participants at three different times: immediately (T 0 ), three months (T 1 ) and six months (T 2 ) after treatment. Irregularity index, inter-canine and inter-molar width, and arch length were recorded using software. Additionally, a full periodontal assessment was carried out at T 2 . RESULTS During the follow-ups, all groups showed some relapse in the lower anterior teeth. No statistical significance was found intergroup in terms of all measured values. Within the multi-stranded group, inter-canine width had decreased by 0.10 mm with a statistical significance (P = .048). An additional statistical significance with P = .045 was found within the single-stranded group regarding the increased arch length. The periodontal assessment results of the mandibular anterior teeth between groups did not show clinically significant differences. CONCLUSION No statistical significance was found between the CAD/CAM retainer and other retainers regarding the clinical failure rate. Less plaque accumulation and gingival inflammation were observed in the CAD/CAM NiTi retainer group.",2021,"Within the multi-stranded group, inter-canine width had decreased by 0.10mm with a statistical significance (P=0.048).",['60 participants from both genders who had irregularities prior to orthodontic therapy and who had been treated with full-fixed appliances mechanotherapy'],"['CAD/CAM Nickel Titanium lingual retainers', 'CAD/CAM NiTi retainer, multi-stranded stainless-steel, single-stranded nickel-free titanium, and vacuum-formed removable retainer groups', 'CAD/CAM Nickel-Titanium retainer', 'conventional fixed and removable retainers']","['teeth stability and periodontal health', 'Irregularity index, inter-canine and inter-molar width, and arch length', 'plaque accumulation and gingival inflammation', 'canine width', 'stability of mandibular anterior teeth and periodontal health']","[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}]","[{'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C0068790', 'cui_str': 'nitinol'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0242919', 'cui_str': 'Orthodontic retainer'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0038126', 'cui_str': 'Stainless steel material'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0028013', 'cui_str': 'nickel'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}]","[{'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C4544584', 'cui_str': 'Distance between molar teeth'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}]",60.0,0.0503102,"Within the multi-stranded group, inter-canine width had decreased by 0.10mm with a statistical significance (P=0.048).","[{'ForeName': 'Mohamad Basel', 'Initials': 'MB', 'LastName': 'Alrawas', 'Affiliation': 'Department of Orthodontics, School of Dentistry, Near East University, Nicosia, Turkey.'}, {'ForeName': 'Yaman', 'Initials': 'Y', 'LastName': 'Kashoura', 'Affiliation': 'Department of Orthodontics, School of Dentistry, Near East University, Nicosia, Turkey.'}, {'ForeName': 'Özgür', 'Initials': 'Ö', 'LastName': 'Tosun', 'Affiliation': 'Department of Biostatistics, School of Medicine, Near East University, Nicosia, Turkey.'}, {'ForeName': 'Ulaş', 'Initials': 'U', 'LastName': 'Öz', 'Affiliation': 'Department of Orthodontics, School of Dentistry, Near East University, Nicosia, Turkey.'}]",Orthodontics & craniofacial research,['10.1111/ocr.12425'] 1288,32852600,Does patient-specific instrumentation increase the risk of notching in the anterior femoral cortex in total knee arthroplasty? A comparative prospective trial.,"PURPOSE Patient-specific instrumentation (PSI) was usually applied in total knee arthroplasty (TKA) to acquire a favourable alignment. We hypothesized that using PSI had a potential risk of notching in the anterior femoral cortex, because the femoral component may be placed in an overextension position due to the distal femoral sagittal anteversion. The aim of this study was to figure out the relationship between the notch and the distal femoral sagittal anteversion in PSI-assisted TKA. METHODS One hundred thirty-one patients who were to undergo total knee arthroplasty (TKA) were randomly divided into conventional instrumentation (CI) group and PSI group. The computed tomography (CT) data of lower extremities was collected and imported to the Mimics software to reconstruct the three-dimensional (3D) bone image of the femur. The angle between distal femoral anatomic axis (DFAA) and femoral mechanical axis (FMA) on sagittal plane was defined as distal femoral sagittal anteverted angle (DFSAA) and measured. The number of notch intra-operative and post-operative was recorded. Then, we calculated the incidence of the notch and analyzed its relationship with DFSAA. RESULTS The average DFSAA of 262 femurs is 2.5° ± 1.5° (range, 0.0°-5.7°). When DFSAA ≥ 3°, the incidence of notch was 7.10% in CI group and 33.30% in PSI group, respectively, which shows significant statistical difference in the two groups (P = 0.016 < 0.05). When DFSAA < 3°, the incidence of notch was 6.50% in CI group and 5.30% in PSI group, respectively, which shows no significant statistical difference in the two groups (P = 0.667 > 0.05). CONCLUSION DFSAA could be taken as an indicator to predict the notch when performing TKA assisted with PSI. Especially when the DFSAA ≥ 3°, the risk of notch could be markedly increased.",2020,"When DFSAA < 3°, the incidence of notch was 6.50% in CI group and 5.30% in PSI group, respectively, which shows no significant statistical difference in the two groups (P = 0.667 > 0.05). ",['One hundred thirty-one patients who were to undergo total knee arthroplasty (TKA'],['conventional instrumentation (CI) group and PSI group'],"['incidence of notch', 'number of notch intra-operative and post-operative', 'distal femoral anatomic axis (DFAA) and femoral mechanical axis (FMA']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205316', 'cui_str': 'Notched'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}]",131.0,0.0329578,"When DFSAA < 3°, the incidence of notch was 6.50% in CI group and 5.30% in PSI group, respectively, which shows no significant statistical difference in the two groups (P = 0.667 > 0.05). ","[{'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Ke', 'Affiliation': 'Department of Orthopaedics, Xinqiao Hospital, Army Medical University (Third Military Medical University), Chongqing, 400037, China.'}, {'ForeName': 'Tianfei', 'Initials': 'T', 'LastName': 'Ran', 'Affiliation': 'Department of Orthopaedics, Xinqiao Hospital, Army Medical University (Third Military Medical University), Chongqing, 400037, China.'}, {'ForeName': 'Yongqin', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Orthopaedics, Xinqiao Hospital, Army Medical University (Third Military Medical University), Chongqing, 400037, China.'}, {'ForeName': 'Mingrui', 'Initials': 'M', 'LastName': 'Lv', 'Affiliation': 'Department of Orthopaedics, Xinqiao Hospital, Army Medical University (Third Military Medical University), Chongqing, 400037, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'Department of Orthopaedics, Xinqiao Hospital, Army Medical University (Third Military Medical University), Chongqing, 400037, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthopaedics, Xinqiao Hospital, Army Medical University (Third Military Medical University), Chongqing, 400037, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopaedics, Xinqiao Hospital, Army Medical University (Third Military Medical University), Chongqing, 400037, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedics, Xinqiao Hospital, Army Medical University (Third Military Medical University), Chongqing, 400037, China. 52solar@sina.cn.'}]",International orthopaedics,['10.1007/s00264-020-04779-4'] 1289,32854153,Integrating high-intensity interval training into the workplace: The Work-HIIT pilot RCT.,"The purpose of this study was to assess the feasibility and preliminary efficacy of a high-intensity interval training (HIIT) intervention integrated into the workplace on physical and mental health outcomes in a sample of adults. The Work-HIIT intervention was evaluated at the University of Newcastle (March-July 2019). University employees (18+ years) who self-identified as predominantly sedentary at work (n = 47, 43.0 ± 10.7 years; 41 female) were recruited, screened, and randomized after baseline assessments into Work-HIIT (n = 24) or wait-list control (n = 23) conditions. Participants were asked to attend 2-3 researcher-facilitated HIIT sessions/week (weeks 1-8). Sessions included a 2-minute gross-motor warm-up, followed by various combinations of aerobic and muscular fitness exercises lasting 8 minutes (using 30:30 second work: rest intervals). Program feasibility was assessed using measures of satisfaction, compliance, adherence, fidelity, and retention. Physiological and psychological outcomes were measured at baseline and 9 weeks. Feasibility data were investigated using descriptive statistics and efficacy outcomes determined using linear mixed models and Cohen's d effect sizes. Participant ratings showed high levels of satisfaction (4.6/5); 71% of participants attended ≥2 sessions/wk and averaged 85.9% HR max across all sessions (including rest and work intervals). Small-to-medium positive effects resulted for cardiorespiratory fitness [+2.9 laps, 95% CI (-4.19-10.14); d = 0.34] and work productivity [+0.26, d = 0.47]. Large positive effects resulted for muscular fitness [push-ups +3.5, d = 0.95; standing jump +10.1 cm, d = 1.12]; HIIT self-efficacy [+16.53, d = 1.57]; sleep [weekday +0.76 hours, d = 1.05]; and autonomous motivation [+0.23, d = 0.76]. This study supports the feasibility and preliminary efficacy of facilitator-led Work-HIIT as a time-efficient, enjoyable, and convenient workplace exercise option for adults.",2020,Participant ratings showed high levels of satisfaction (4.6/5); 71% of participants attended ≥2 sessions/week and averaged 85.9%HR max across all sessions (including rest and work intervals).,"['adults', 'a sample of adults', 'University employees (18+yrs) who self-identified as predominantly sedentary at work (n=47, 43.0 ± 10.7yrs; 41 female']","['wait-list control', 'high intensity interval training (HIIT) intervention', 'facilitator-led Work-HIIT', '2-minute gross-motor warm-up, followed by various combinations of aerobic and muscular fitness exercises lasting 8-minutes']","['cardio-respiratory fitness', 'physical and mental health outcomes', 'satisfaction, compliance, adherence, fidelity, and retention', 'muscular fitness', 'Physiological and psychological outcomes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C3540029', 'cui_str': 'various combinations'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]",,0.0516742,Participant ratings showed high levels of satisfaction (4.6/5); 71% of participants attended ≥2 sessions/week and averaged 85.9%HR max across all sessions (including rest and work intervals).,"[{'ForeName': 'Narelle', 'Initials': 'N', 'LastName': 'Eather', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Babic', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Riley', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Harris', 'Affiliation': 'Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Jung', 'Affiliation': 'University of British Columbia, Callaghan, BC, Canada.'}, {'ForeName': 'Mikeelie', 'Initials': 'M', 'LastName': 'Jeffs', 'Affiliation': 'Faculty of Education and Arts, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Briana', 'Initials': 'B', 'LastName': 'Barclay', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Lubans', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, NSW, Australia.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13811'] 1290,32861537,"The effect of age on efficacy, safety and patient-centered outcomes with rucaparib: A post hoc exploratory analysis of ARIEL3, a phase 3, randomized, maintenance study in patients with recurrent ovarian carcinoma.","BACKGROUND In the phase 3 trial ARIEL3, maintenance treatment with the poly(ADP-ribose) polymerase (PARP) inhibitor rucaparib provided clinical benefit versus placebo for patients with recurrent, platinum-sensitive ovarian cancer. Here, we evaluate the impact of age on the clinical utility of rucaparib in ARIEL3. METHODS Patients with platinum-sensitive, recurrent ovarian carcinoma with ≥2 prior platinum-based chemotherapies who responded to their last platinum-based therapy were enrolled in ARIEL3 and randomized 2:1 to rucaparib 600 mg twice daily or placebo. Exploratory, post hoc analyses of progression-free survival (PFS), patient-centered outcomes (quality-adjusted PFS [QA-PFS] and quality-adjusted time without symptoms or toxicity [Q-TWiST]), and safety were conducted in three age subgroups (<65 years, 65-74 years, and ≥75 years). RESULTS Investigator-assessed PFS was significantly longer with rucaparib than placebo in patients aged <65 years (rucaparib n = 237 vs placebo n = 117; median, 11.1 vs 5.4 months; hazard ratio [HR]: 0.33 [95% confidence interval (95% CI) 0.25-0.43]; P < 0.0001) and 65-74 years (n = 113 vs n = 64; median, 8.3 vs 5.3 months; HR 0.43 [95% CI 0.29-0.63]; P < 0.0001) and numerically longer in patients aged ≥75 years (n = 25 vs n = 8; median, 9.2 vs 5.5 months; HR 0.47 [95% CI 0.16-1.35]; P = 0.1593). QA-PFS and Q-TWiST were significantly longer with rucaparib than placebo across all age subgroups. Safety of rucaparib was generally similar across the age subgroups. CONCLUSIONS Efficacy, patient-centered outcomes, and safety of rucaparib were similar between age subgroups, indicating that all eligible women with recurrent ovarian cancer should be offered this therapeutic option, irrespective of age. https://clinicaltrials.gov/ct2/show/NCT01968213.",2020,QA-PFS and Q-TWiST were significantly longer with rucaparib than placebo across all age subgroups.,"['patients with recurrent ovarian carcinoma', 'eligible women with recurrent ovarian cancer', 'three age subgroups (<65\xa0years, 65-74\xa0years, and ≥75\xa0years', 'patients with recurrent, platinum-sensitive ovarian cancer', 'patients aged <65\xa0years (rucaparib n\xa0=\xa0237 vs placebo n\xa0', 'Patients with platinum-sensitive, recurrent ovarian carcinoma with ≥2 prior platinum-based chemotherapies who responded to their last platinum-based therapy']","['rucaparib 600\xa0mg twice daily or placebo', 'rucaparib', 'placebo', 'poly(ADP-ribose) polymerase (PARP) inhibitor rucaparib']","['progression-free survival (PFS), patient-centered outcomes (quality-adjusted PFS [QA-PFS] and quality-adjusted time without symptoms or toxicity [Q-TWiST]), and safety', 'Safety of rucaparib', 'QA-PFS and Q-TWiST', 'PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C3661315', 'cui_str': 'rucaparib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C3661315', 'cui_str': 'rucaparib'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032405', 'cui_str': 'Poly ADP Ribose Polymerase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0040480', 'cui_str': 'Torsion'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3661315', 'cui_str': 'rucaparib'}]",,0.375328,QA-PFS and Q-TWiST were significantly longer with rucaparib than placebo across all age subgroups.,"[{'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': 'Gynecologic Cancer Program, University of Milan-Bicocca and European Institute of Oncology IRCCS, via Ripamonti 435, 20146 Milan, Italy. Electronic address: nicoletta.colombo@ieo.it.'}, {'ForeName': 'Amit M', 'Initials': 'AM', 'LastName': 'Oza', 'Affiliation': 'Division of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, 610 University Ave, Toronto, ON, Canada.'}, {'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Lorusso', 'Affiliation': 'Gynecologic Oncology Unit, Policlinico Universitario A. Gemelli IRCCS, 00168 Rome, Italy.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Aghajanian', 'Affiliation': 'Gynecologic Medical Oncology, Memorial Sloan Kettering Cancer Center, 1275 York Ave, New York, NY 10065, USA.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Oaknin', 'Affiliation': ""Medical Oncology Department, Vall d'Hebron Institute of Oncology, C/Natzaret, 115-117, 08035 Barcelona, Spain.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Dean', 'Affiliation': 'Department of Medical Oncology, St John of God Hospital Subiaco, 12 Salvado Rd, Subiaco, WA 6008, Australia.'}, {'ForeName': 'Johanne I', 'Initials': 'JI', 'LastName': 'Weberpals', 'Affiliation': 'Division of Gynecologic Oncology, Ottawa Hospital Research Institute, 501 Smyth Rd, Ottawa, ON K1H 8L6, Canada.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Clamp', 'Affiliation': 'Department of Medical Oncology, The Christie NHS Foundation Trust and University of Manchester, Manchester M20 4BX, UK.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': 'Gynecologic Oncology Unit, Policlinico Universitario A. Gemelli IRCCS, 00168 Rome, Italy.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Leary', 'Affiliation': ""Gynecological Unit, Gustave Roussy Cancer Center, INSERM U981, and Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO), 98405 Villejuif, France.""}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Holloway', 'Affiliation': 'Gynecologic Oncology, Advent Health Cancer Institute, 601 East Rollins St, Orlando, FL 32803, USA.'}, {'ForeName': 'Margarita Amenedo', 'Initials': 'MA', 'LastName': 'Gancedo', 'Affiliation': 'Medical Oncology Department, Oncology Center of Galicia, Rúa Doctor Camilo Veiras, 1, 15009 La Coruña, Spain.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Fong', 'Affiliation': 'Medical Oncology Department, Auckland City Hospital, Grafton, 2 Park Road, Grafton, Auckland 1023, New Zealand.'}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Goh', 'Affiliation': ""Department of Oncology, Cancer Care Services, Royal Brisbane and Women's Hospital, and University of Queensland, Cnr Butterfield St and Bowen Bridge Rd, Herston, QLD 4029, Australia.""}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': ""O'Malley"", 'Affiliation': 'Gynecologic Oncology, James Cancer Center, The Ohio State University, Starling-Loving Hall, 320 West 10th Ave, Columbus, OH 43210, USA.'}, {'ForeName': 'Deborah K', 'Initials': 'DK', 'LastName': 'Armstrong', 'Affiliation': 'Gynecology and Obstetrics, Johns Hopkins University Medical Center, 601 N Caroline St, Baltimore, MD 21287, USA.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Gynaecology Unit, The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, Fulham Road, London SW3 6JJ, UK.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'García-Donas', 'Affiliation': 'Division of Medical Oncology, HM Hospitales-Centro Integral Oncológico Hospital de Madrid Clara Campal, Calle Oña 10, 28050 Sanchinarro, Madrid, Spain.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Swisher', 'Affiliation': 'Division of Gynecologic Oncology, University of Washington, 1959 NE Pacific Street, Box 356460, Seattle, WA 98195, USA.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Meunier', 'Affiliation': 'Modus Outcomes, 61 Cours de la Liberte, 69003 Lyon, France.'}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Cameron', 'Affiliation': 'Clinical Science, Clovis Oncology UK Ltd., Granta Centre, Granta Park, Great Abington, Cambridge CB21 6GP, UK.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Maloney', 'Affiliation': 'Clinical Development, Clovis Oncology, Inc., 5500 Flatiron Parkway, Boulder, CO 80301, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Goble', 'Affiliation': 'Biostatistics, Clovis Oncology, Inc., 5500 Flatiron Parkway, Boulder, CO 80301, USA.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Bedel', 'Affiliation': 'Pricing & Market Access - Europe, Clovis Oncology Switzerland GmBH, Seefeldstrasse 69, 8008 Zurich, Switzerland.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Ledermann', 'Affiliation': 'Department of Oncology, UCL Cancer Institute, University College London and UCL Hospitals, 72 Huntley St, London WC1E 6DD, UK.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, USA.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.05.045'] 1291,32865025,The probiotic Lactobacillus casei Shirota attenuates symptoms of vestibular migraine: a randomised placebo-controlled double-blind clinical trial.,"Vestibular migraine (VM) has emerged as one of the major vestibular syndromes. Although probiotics have exhibited beneficial effects on migraine headache, its effect on VM is not clear. This trial aimed to investigate the treatment efficacy of the probiotic Lactobacillus casei Shirota (LcS) on symptoms of VM. 247 VM patients were enrolled, of which 204 eligible patients receiving either LcS or placebo on a daily basis completed the 4 month study. They were re-visited at 2 and 4 months after study initiation to assess treatment outcomes. The primary endpoints were vestibular symptoms, evaluated by the number of vertiginous attacks during the past week, the Vertigo Severity Score (VSS), and Dizziness Handicap Inventory (DHI) scores. The secondary endpoints were anxiety and depressive symptoms, evaluated using Beck Anxiety Inventory (BAI) and Beck Depression Inventory (BDI) scores. Efficacy of LcS over placebo was not obvious at 2 month follow-up. At 4 month follow-up, while both LcS and placebo groups of VM patients displayed alleviated symptoms, the extents of the improvements were significantly better in LcS group than those of placebo group, with regard to vestibular symptoms using DHI and VSS, as well as anxiety and depressive symptoms using BAI and BDI. Although placebo effect cannot be ignored in intervention for VM patients, the probiotic LcS still exhibits considerable efficacy against VM symptoms over a 4 month study period, supporting further clinical study of a larger and more diverse cohort.",2020,Efficacy of LcS over placebo was not obvious at 2 month follow-up.,"['on a daily basis completed the 4 month study', '247 VM patients were enrolled, of which 204 eligible patients receiving either']","['probiotic Lactobacillus casei', 'LcS over placebo', 'LcS or placebo', 'placebo', 'probiotic Lactobacillus casei Shirota (LcS']","['anxiety and depressive symptoms using BAI and BDI', 'vestibular symptoms, evaluated by the number of vertiginous attacks during the past week, the Vertigo Severity Score (VSS), and Dizziness Handicap Inventory (DHI) scores', 'Shirota attenuates symptoms of vestibular migraine', 'migraine headache', 'anxiety and depressive symptoms, evaluated using Beck Anxiety Inventory (BAI) and Beck Depression Inventory (BDI) scores']","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0395920', 'cui_str': 'Migrainous vertigo'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0022940', 'cui_str': 'Lactobacillus casei'}, {'cui': 'C0268314', 'cui_str': 'Cholestasis-edema syndrome, Norwegian type'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C4304791', 'cui_str': 'Dizziness Handicap Inventory score'}, {'cui': 'C0395920', 'cui_str': 'Migrainous vertigo'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C2960571', 'cui_str': 'Beck depression inventory score'}]",247.0,0.212322,Efficacy of LcS over placebo was not obvious at 2 month follow-up.,"[{'ForeName': 'X', 'Initials': 'X', 'LastName': 'Qi', 'Affiliation': 'Department of No.4 neurology, Cangzhou Central Hospital, Xinhua Road, Cangzhou 061000, Hebei, China.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Fan', 'Affiliation': 'Department of No.4 neurology, Cangzhou Central Hospital, Xinhua Road, Cangzhou 061000, Hebei, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Jia', 'Affiliation': 'Department of No.4 neurology, Cangzhou Central Hospital, Xinhua Road, Cangzhou 061000, Hebei, China.'}]",Beneficial microbes,['10.3920/BM2020.0058'] 1292,32861897,Testing an app-based intervention to improve insomnia in patients with epilepsy: A randomized controlled trial.,"PURPOSE Insomnia has adverse effects on people with epilepsy. We aimed to test a novel cognitive behavioral therapy for insomnia (CBT-I) app-based intervention on insomnia symptoms and social psychological factors in people with epilepsy and to examine the possible mechanisms among the factors. METHODS Participants were recruited from neurology clinics in Iran and comprised individuals diagnosed with epilepsy and having moderate to severe insomnia. A two-arm randomized controlled trial design was used, consisting of a treatment group (CBT-I; n = 160) and control group (patient education; n = 160). Primary outcomes were self-reported sleep quality, insomnia severity, and sleep hygiene behavior and objective sleep characteristics measured by actigraphy. Secondary outcomes were attitude, perceived behavioral control, intention, action planning, coping planning, behavioral automaticity, self-monitoring, anxiety, depression, and quality of life (QoL). All outcomes were measured at baseline, and at one, three, and six months postintervention, except objective sleep, which was assessed at baseline, and one and six months postintervention. Data were analyzed using linear mixed models. RESULTS Current findings showed that sleep quality, insomnia severity, sleep hygiene behavior, and sleep onset latency were significantly improved in the CBT-I group compared with the patient education group at all measurement points. Also, the CBT-I group had significantly improved anxiety, depression, and QoL compared with the patient education group. Mediation analyses showed that attitude, intention, coping planning, self-monitoring, and behavioral automaticity significantly mediated the effect of the intervention on sleep outcomes. CONCLUSION Results support the use of the CBT-I app to improve sleep outcomes among people with epilepsy.",2020,"Mediation analyses showed that attitude, intention, coping planning, self-monitoring, and behavioral automaticity significantly mediated the effect of the intervention on sleep outcomes. ","['patients with epilepsy', 'people with epilepsy', 'Participants were recruited from neurology clinics in Iran and comprised individuals diagnosed with epilepsy and having moderate to severe insomnia']","['Testing an app-based intervention', 'novel cognitive behavioral therapy for insomnia (CBT-I) app-based intervention']","['insomnia symptoms and social psychological factors', 'sleep quality, insomnia severity, sleep hygiene behavior, and sleep onset latency', 'attitude, intention, coping planning, self-monitoring, and behavioral automaticity', 'anxiety, depression, and QoL', 'self-reported sleep quality, insomnia severity, and sleep hygiene behavior and objective sleep characteristics measured by actigraphy', 'attitude, perceived behavioral control, intention, action planning, coping planning, behavioral automaticity, self-monitoring, anxiety, depression, and quality of life (QoL', 'sleep outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3814532', 'cui_str': 'Neurology clinic'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033898', 'cui_str': 'Factors, Psychological'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0878237,"Mediation analyses showed that attitude, intention, coping planning, self-monitoring, and behavioral automaticity significantly mediated the effect of the intervention on sleep outcomes. ","[{'ForeName': 'Daniel Kwasi', 'Initials': 'DK', 'LastName': 'Ahorsu', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Health & Social Sciences, The Hong Kong Polytechnic University, Hung Hom, Hong Kong.'}, {'ForeName': 'Chung-Ying', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Health & Social Sciences, The Hong Kong Polytechnic University, Hung Hom, Hong Kong.'}, {'ForeName': 'Vida', 'Initials': 'V', 'LastName': 'Imani', 'Affiliation': 'Pediatric Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Carlbring', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Nygårdh', 'Affiliation': 'Department of Nursing, School of Health and Welfare, Jönköping University, Jönköping, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Broström', 'Affiliation': 'Department of Nursing, School of Health and Welfare, Jönköping University, Jönköping, Sweden; Department of Clinical Neurophysiology, University Hospital, Linköping, Sweden.'}, {'ForeName': 'Kyra', 'Initials': 'K', 'LastName': 'Hamilton', 'Affiliation': 'School of Applied Psychology, Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia.'}, {'ForeName': 'Amir H', 'Initials': 'AH', 'LastName': 'Pakpour', 'Affiliation': 'Department of Nursing, School of Health and Welfare, Jönköping University, Jönköping, Sweden; Social Determinants of Health Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran. Electronic address: Pakpour_Amir@yahoo.com.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107371'] 1293,32863275,Cost-effectiveness of robotic hysterectomy versus abdominal hysterectomy in early endometrial cancer.,"OBJECTIVES To compare total costs for hospital stay and post-operative recovery between robotic and abdominal hysterectomy in the treatment of early-stage endometrial cancer provided in an enhanced recovery after surgery (ERAS) setting. Costs were evaluated in relation to health impact, taking a societal perspective. METHODS Cost analysis was based on data from an open randomized controlled trial in an ERAS setting at a Swedish tertiary referral university hospital: 50 women with low-risk endometrial cancer scheduled for surgery between February 2012 and May 2016 were included; 25 women were allocated to robotic and 25 to abdominal hysterectomy. We compared the total time in the operating theater, procedure costs, post-operative care, length of hospital stay, readmissions, informal care, and sick leave as well as the health-related quality of life until 6 weeks after surgery. The comparison was made by using the EuroQoL group form with five dimensions and three levels (EQ-5D). The primary outcome measure was total cost; secondary outcomes were quality-adjusted life-years (QALYs) and cost per QALY. The costs were calculated in Swedish Krona (SEK). RESULTS Age (median (IQR) 68 (63-72) vs 67 (59-75) years), duration of hospital stay (ie, time to discharge criteria were met) (median (IQR) 36 (36-36) vs 36 (36-54) hours), and sick leave (median (IQR) 25 (17-30) vs 31 (36-54) days) did not differ between the robotic and abdominal group. Time of surgery was significantly longer in the robotic group than in the abdominal group (median (IQR) 70 (60-90) vs 56 (49-84) min; p<0.05). The robotic group recovered significantly faster as measured by the EQ-5D health index and gained 0.018 QALYs until 6 weeks after surgery. Total costs were 20% higher for the robotic procedure (SEK71 634 vs SEK59 319). The total cost per QALY gained for women in the robotic group was slightly under SEK700 000. CONCLUSIONS Robotic hysterectomy used in an ERAS setting in the treatment of early endometrial cancer improved health within 6 weeks after the operation at a high cost for the health gained compared with abdominal hysterectomy. The productivity loss and informal care were lower for robotic hysterectomy, while healthcare had a higher procedure cost that could not be offset by the higher cost due to complications in the abdominal group.",2020,The robotic group recovered significantly faster as measured by the EQ-5D health index and gained 0.018 QALYs until 6 weeks after surgery.,"['ERAS setting at a Swedish tertiary referral university hospital: 50 women with low-risk endometrial cancer scheduled for surgery between February 2012 and May 2016 were included; 25 women', 'early-stage endometrial cancer', 'early endometrial cancer']","['Robotic hysterectomy', 'robotic and 25 to abdominal hysterectomy', 'robotic hysterectomy versus abdominal hysterectomy', 'robotic and abdominal hysterectomy']","['Time of surgery', 'productivity loss and informal care', 'Total costs', 'EQ-5D health index', 'sick leave', 'duration of hospital stay ', 'total cost; secondary outcomes were quality-adjusted life-years (QALYs) and cost per QALY', 'total cost per QALY gained', 'total time in the operating theater, procedure costs, post-operative care, length of hospital stay, readmissions, informal care, and sick leave as well as the health-related quality of life']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0404077', 'cui_str': 'Abdominal hysterectomy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C3494177', 'cui_str': 'Informal care'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0029064', 'cui_str': 'Operating theatre'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",25.0,0.184568,The robotic group recovered significantly faster as measured by the EQ-5D health index and gained 0.018 QALYs until 6 weeks after surgery.,"[{'ForeName': 'Evelyn Serreyn', 'Initials': 'ES', 'LastName': 'Lundin', 'Affiliation': 'Department of Obstetrics and Gynecology in Linköping, and Department of Biomedical and Clinical Sciences, Linköpings Universitet, Linköping, Sweden evelyn.lundin@regionostergotland.se.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Carlsson', 'Affiliation': 'Division of Society and Health, Department of Health, Medicine and Caring Sciences, Linköpings Universitet, Linköping, Sweden.'}, {'ForeName': 'Ninnie Borendal', 'Initials': 'NB', 'LastName': 'Wodlin', 'Affiliation': 'Department of Obstetrics and Gynecology in Linköping, and Department of Biomedical and Clinical Sciences, Linköpings Universitet, Linköping, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Nilsson', 'Affiliation': 'Department of Anesthesiology and Intensive Care in Linköping, and Department of Biomedical and Clinical Sciences, Linköpings Universitet, Linköping, Sweden.'}, {'ForeName': 'Preben', 'Initials': 'P', 'LastName': 'Kjölhede', 'Affiliation': 'Department of Obstetrics and Gynecology in Linköping, and Department of Biomedical and Clinical Sciences, Linköpings Universitet, Linköping, Sweden.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001611'] 1294,32870276,Splinting in Carpal Tunnel Syndrome: The Optimal Duration.,"INTRODUCTION The purpose of this study was to evaluate optimal neutral wrist splint duration in treatment-naive mild and mild to moderate carpal tunnel syndrome (CTS). Neutral wrist splinting is a conservative treatment for CTS; however, no clear guidelines exist for how long splinting should be prescribed for optimal outcomes. MATERIALS AND METHODS In this prospective clinical trial subjects were assigned to wear a neutral wrist splint for 6 (group A) or 12 weeks (group B). Symptom and functional outcomes were assessed by questionnaire at baseline, 6 and 12 weeks. Median nerve sensory and motor latencies were recorded at baseline and 12 weeks. Pretreatment, midtreatment, and posttreatment measures were compared within and between treatment groups where applicable. This study was approved by the United States Air Force Academy institutional review board. RESULTS A total of 30 subjects (37 hands) were randomized to 2 treatment groups. Mean symptom severity and median sensory peak latency significantly improved in both groups at 12 weeks, without a significant difference between groups. Mean functional severity significantly improved only in group A. CONCLUSION Neutral wrist splint for 6 weeks resulted in better clinical improvements in patients with untreated mild and mild to moderate CTS. There was no additional benefit in extending splinting 6 additional weeks. This is the first study to compare duration of wrist splint use beyond 8 weeks. A larger sample size is needed to identify the reason for lack of functional improvement in group B. Long-term follow-up of this cohort will be helpful to determine the natural history of initial wrist splint use.",2020,"Mean symptom severity and median sensory peak latency significantly improved in both groups at 12 weeks, without a significant difference between groups.","['patients with untreated mild and mild to moderate CTS', 'Carpal Tunnel Syndrome', 'treatment-naive mild and mild to moderate carpal tunnel syndrome (CTS', '30 subjects (37 hands']","['Neutral wrist splint', 'Neutral wrist splinting', 'neutral wrist splint', 'neutral wrist splint duration']","['Mean symptom severity and median sensory peak latency', 'Median nerve sensory and motor latencies', 'Mean functional severity', 'Symptom and functional outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]","[{'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0204861', 'cui_str': 'Application of splint'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0025058', 'cui_str': 'Structure of median nerve'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",30.0,0.0386435,"Mean symptom severity and median sensory peak latency significantly improved in both groups at 12 weeks, without a significant difference between groups.","[{'ForeName': 'Michele A', 'Initials': 'MA', 'LastName': 'Gatheridge', 'Affiliation': 'United States Air Force Academy, 10th Medical Group, 4102 Pinion Dr., USAF Academy, CO 80840.'}, {'ForeName': 'Elsa A', 'Initials': 'EA', 'LastName': 'Sholty', 'Affiliation': 'United States Air Force Academy, 10th Medical Group, 4102 Pinion Dr., USAF Academy, CO 80840.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Inman', 'Affiliation': 'United States Air Force Academy, 10th Medical Group, 4102 Pinion Dr., USAF Academy, CO 80840.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Pattillo', 'Affiliation': 'Department of Mathematics, United States Air Force Academy, 2354 Fairchild Drive, Suite 6D102, USAF Academy, CO 80840.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Mindrup', 'Affiliation': 'Department of Mathematics, United States Air Force Academy, 2354 Fairchild Drive, Suite 6D102, USAF Academy, CO 80840.'}, {'ForeName': 'Dawn L', 'Initials': 'DL', 'LastName': 'Sanderson', 'Affiliation': 'Department of Mathematics, United States Air Force Academy, 2354 Fairchild Drive, Suite 6D102, USAF Academy, CO 80840.'}]",Military medicine,['10.1093/milmed/usaa222'] 1295,32862469,Determining Thresholds for Meaningful Change for the Headache Impact Test (HIT-6) Total and Item-Specific Scores in Chronic Migraine.,"OBJECTIVE The objective of the analyses described here was to develop thresholds defining clinically meaningful response on the total and item scores of the 6-item short-form Headache Impact Test (HIT-6) in a population of patients with chronic migraine (CM). BACKGROUND The HIT-6 is a short, easily understood, and useful measure of the impact of headache on daily life. Though widely used, limited literature supports a threshold value for clinically meaningful response within individuals over time for the HIT-6 total score and for the item scores, especially in the CM population. METHODS PROMISE-2 is a randomized, double-blind, multicenter study comparing intravenous eptinezumab 100 and 300 mg with placebo for the preventive treatment of CM. Responder definitions for HIT-6 total and items scores using data from PROMISE-2 study were calculated via distribution-based and anchor-based methods. Distribution-based methods included half of the baseline standard deviation and baseline standard error of measurement. The change from baseline to week 12 in HIT-6 scores was assessed using the following anchors: patient global impression of change, reduction in migraine frequency, and change in EuroQol 5 dimensions 5 levels visual analog scale. Values from the literature and PROMISE-2 analyses were plotted against the cumulative distribution function of change values (baseline to week 12) and used to triangulate to empirically support clinically meaningful change definitions for the HIT-6 total and item scores in patients with CM. RESULTS From the literature, 5 articles provided 7 candidate values for a responder threshold for the HIT-6 total score. From distribution- and anchor-based methods, 5 candidate values were derived from PROMISE-2 data. Using the median of all candidate values, a HIT-6 total score responder definition estimate of -6 (ie, ≥6-point improvement in the total score) appears most appropriate for discriminating between individuals with CM who have experienced meaningful change over time and those who have not. For item-level analyses using anchor-based methods, the responder definition for items 1-3 (""severe pain,"" ""limits daily activities,"" and ""lie down"") was a 1-category improvement in response (eg, from Sometimes to Rarely); for items 4-6 (""too tired,"" ""felt fed up or irritated,"" and ""limits concentration""), a 2-category improvement in response (eg, from Always to Sometimes) was clinically meaningful. CONCLUSIONS Using a multifaceted, statistically-based approach, the recommended responder definition for the HIT-6 total score in the CM population is a ≥6-point decrease, consistent with previous literature. Anchor-based item-level responder thresholds were defined as a decrease of 1 or 2 categories, depending on the item. These CM-specific values will provide researchers and clinicians a means to interpret clinically meaningful change in the HIT-6 total and item scores and may facilitate the measurement of treatment benefits in specific functional domains of the HIT-6.",2020,The change from baseline to week 12 in HIT-6,['patients with chronic migraine (CM'],['intravenous eptinezumab 100 and 300 mg with placebo'],"['Headache Impact Test (HIT-6) Total and Item-Specific Scores', 'migraine frequency, and change in EuroQol 5 dimensions 5 levels visual analog scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4694272', 'cui_str': 'eptinezumab'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0898891,The change from baseline to week 12 in HIT-6,"[{'ForeName': 'Carrie R', 'Initials': 'CR', 'LastName': 'Houts', 'Affiliation': 'Vector Psychometric Group, LLC, Chapel Hill, NC, USA.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Wirth', 'Affiliation': 'Vector Psychometric Group, LLC, Chapel Hill, NC, USA.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'McGinley', 'Affiliation': 'Vector Psychometric Group, LLC, Chapel Hill, NC, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Cady', 'Affiliation': 'Neurology, Lundbeck Seattle BioPharmaceuticals, Inc., Bothell, WA, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'Neurology, Epidemiology and Population Health, Psychiatry and Behavioral Sciences, Division of Cognitive Aging and Dementia, Montefiore Headache Center, Albert Einstein College of Medicine, Bronx, NY, USA.'}]",Headache,['10.1111/head.13946'] 1296,32864166,Brief communication: immunogenicity of measles vaccine when co-administered with 10-valent pneumococcal conjugate vaccine.,"This brief communication describes the findings from a randomised controlled trial in Vietnam that co-administration of measles vaccine (MV) with 10-valent pneumococcal conjugate vaccine (PCV10, Synflorix®, GSK) does not affect the immunogenicity of MV. These findings are most relevant for low- and middle-income countries (LMICs) in Asia considering PCV introduction.",2020,These findings are most relevant for low- and middle-income countries (LMICs) in Asia considering PCV introduction.,[],"['10-valent pneumococcal conjugate vaccine', 'measles vaccine (MV) with 10-valent pneumococcal conjugate vaccine (PCV10, Synflorix®, GSK']",['immunogenicity of MV'],[],"[{'cui': 'C3849486', 'cui_str': '10-valent pneumococcal conjugate vaccine'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C3252923', 'cui_str': 'synflorix'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}]",,0.355424,These findings are most relevant for low- and middle-income countries (LMICs) in Asia considering PCV introduction.,"[{'ForeName': 'Zheng Quan', 'Initials': 'ZQ', 'LastName': 'Toh', 'Affiliation': ""New Vaccines, Murdoch Children's Research Institute, Royal Children's Hospital, Parkville, VIC Australia.""}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Temple', 'Affiliation': ""New Vaccines, Murdoch Children's Research Institute, Royal Children's Hospital, Parkville, VIC Australia.""}, {'ForeName': 'Tran Ngoc', 'Initials': 'TN', 'LastName': 'Huu', 'Affiliation': 'Microbiology and Immunology, Pasteur Institute of Ho Chi Minh City, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Vo Thi Trang', 'Initials': 'VTT', 'LastName': 'Dai', 'Affiliation': 'Microbiology and Immunology, Pasteur Institute of Ho Chi Minh City, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nguyen Trong', 'Initials': 'NT', 'LastName': 'Toan', 'Affiliation': 'Department of Disease Control and Prevention, Pasteur Institute of Ho Chi Minh City, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Doan Y', 'Initials': 'DY', 'LastName': 'Uyen', 'Affiliation': 'Department of Disease Control and Prevention, Pasteur Institute of Ho Chi Minh City, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Bright', 'Affiliation': ""New Vaccines, Murdoch Children's Research Institute, Royal Children's Hospital, Parkville, VIC Australia.""}, {'ForeName': 'Lien Anh Ha', 'Initials': 'LAH', 'LastName': 'Do', 'Affiliation': ""New Vaccines, Murdoch Children's Research Institute, Royal Children's Hospital, Parkville, VIC Australia.""}, {'ForeName': 'E Kim', 'Initials': 'EK', 'LastName': 'Mulholland', 'Affiliation': ""New Vaccines, Murdoch Children's Research Institute, Royal Children's Hospital, Parkville, VIC Australia.""}, {'ForeName': 'Paul V', 'Initials': 'PV', 'LastName': 'Licciardi', 'Affiliation': ""New Vaccines, Murdoch Children's Research Institute, Royal Children's Hospital, Parkville, VIC Australia.""}]",NPJ vaccines,['10.1038/s41541-020-00225-z'] 1297,32881148,The effect of desire thinking on facilitating beliefs in alcohol use disorder: An experimental investigation.,Permissive beliefs relate to the acceptability of engaging in alcohol use in spite of obvious potential negative consequences. They are considered the most proximal and precipitating cognitive factor in the decision to use alcohol and/or the activation of strategies to obtain it. Recent research suggested that 'desire thinking' may be involved in the escalation of craving and addictive behaviours and can play a role in strengthening permissive beliefs. The current study tested whether the induction of desire thinking would have a stronger effect on rate of conviction in permissive beliefs compared to a control cognitive response in the form of neutral thinking and whether this effect would be specific for patients with alcohol use disorder (AUD). Thirty AUD patients and 30 social drinkers (SD) were randomly allocated to two thinking manipulation tasks (desire thinking and neutral thinking). Current permissive beliefs were measured before and after manipulation and after a resting phase. Findings showed that desire thinking increased the level of current permissive beliefs after manipulation relative to the neutral thinking condition for the AUD group but not for the SD group. This effect was not purely dependent on the concurrent level of perceived craving. This study supports a causal relationship between the induction of desire thinking and rate of conviction in permissive beliefs and highlights the relevance of targeting desire thinking in the treatment for AUD patients.,2021,The current study tested whether the induction of desire thinking would have a stronger effect on rate of conviction in permissive beliefs compared to a control cognitive response in the form of neutral thinking; and whether this effect would be specific for patients with Alcohol Use Disorder (AUD).,"['AUD patients', 'Thirty AUD patients and 30 social drinkers (SD', 'patients with Alcohol Use Disorder (AUD', 'Alcohol Use Disorder']","['desire thinking', 'thinking manipulation tasks (desire thinking and neutral thinking']",[],"[{'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0337676', 'cui_str': 'Social drinker'}]","[{'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}]",[],30.0,0.0340491,The current study tested whether the induction of desire thinking would have a stronger effect on rate of conviction in permissive beliefs compared to a control cognitive response in the form of neutral thinking; and whether this effect would be specific for patients with Alcohol Use Disorder (AUD).,"[{'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Caselli', 'Affiliation': 'Studi Cognitivi, Milan, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Gemelli', 'Affiliation': 'Studi Cognitivi, Modena, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Ferrari', 'Affiliation': 'Studi Cognitivi, Modena, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Beltrami', 'Affiliation': 'Studi Cognitivi, Modena, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Offredi', 'Affiliation': 'Studi Cognitivi, Milan, Italy.'}, {'ForeName': 'Giovanni M', 'Initials': 'GM', 'LastName': 'Ruggiero', 'Affiliation': 'Studi Cognitivi, Milan, Italy.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Sassaroli', 'Affiliation': 'Studi Cognitivi, Milan, Italy.'}, {'ForeName': 'Marcantonio M', 'Initials': 'MM', 'LastName': 'Spada', 'Affiliation': 'Centre for Addictive Behaviours Research, School of Applied Sciences, London South Bank University, London, UK.'}]",Clinical psychology & psychotherapy,['10.1002/cpp.2511'] 1298,32881281,Changes in vegetable and fruit intakes and effects on anthropometric outcomes in males and females.,"AIM To investigate associations between changes in vegetable and fruit (V&F) intakes and anthropometric indices (weight, BMI, % body fat, waist circumference), including differences by sex, during a dietary weight-loss intervention. METHODS Adults (18-45 years) with overweight/obesity (BMI 25-35 kg/m 2 ) entered a 10-week pre-post study, receiving individualised consults with an Accredited Practising Dietitian targeting increased V&F intakes. Dietary intake was assessed using 24-hour recalls and food frequency questionnaires. Linear mixed models were used to examine how much of the changes in anthropometric indices were explained by changes in V&F intakes. Sex differences were assessed by Wilcoxon rank sum tests. RESULTS Of the 43 participants enrolled, 34 completed the study (53% female). Significant differences in energy intake and anthropometric indices were observed between males and females at baseline. After 10 weeks, females significantly reduced their weight (-2.9%, P < .01), BMI (-0.82 kg/m 2 , P < .01), waist circumference (-1.70 cm, P < .01), energy intake (-824 kJ/day, P = .01) and improved diet quality (-14.0% energy-dense, nutrient-poor foods, P < .01). Males significantly reduced weight (-2.5%, P = .04), BMI (-0.76 kg/m 2 , P = .03), waist circumference (-2.40 cm, P = .02), energy intake (-2875 kJ/day, P < .01), increased fruit intake (+0.89 serves/day, P = .02) and improved diet quality (-6% energy-dense, nutrient-poor foods, P < .01). Compared to the other sex, greater reductions were observed in energy intake in males and energy-dense, nutrient-poor foods in females. Linear mixed models identified that changes in V&F intakes did not explain the variation in anthropometric measures. CONCLUSION Future interventions may benefit from trialling sex tailored messages to enhance effects on anthropometric changes.",2021,"Males significantly reduced weight (-2.5%, P = .04),","['43 participants enrolled', 'males and females', 'Adults (18-45\u2009years) with overweight/obesity (BMI 25-35\u2009kg/m 2 ']",['individualised consults with an Accredited Practising Dietitian targeting increased V&F intakes'],"['BMI', 'weight', 'vegetable and fruit (V&F) intakes and anthropometric indices (weight, BMI, % body fat, waist circumference', 'anthropometric outcomes', 'reduced weight', 'increased fruit intake', 'waist circumference', 'diet quality', 'V&F intakes', 'energy intake and anthropometric indices', 'Dietary intake', 'energy intake']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0556227', 'cui_str': 'Fruit intake'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0556227', 'cui_str': 'Fruit intake'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}]",43.0,0.0329858,"Males significantly reduced weight (-2.5%, P = .04),","[{'ForeName': 'Erin D', 'Initials': 'ED', 'LastName': 'Clarke', 'Affiliation': 'School of Health Sciences, The University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Rollo', 'Affiliation': 'School of Health Sciences, The University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Clare E', 'Initials': 'CE', 'LastName': 'Collins', 'Affiliation': 'School of Health Sciences, The University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Wood', 'Affiliation': 'Centre for Asthma and Respiratory Disease, Hunter Medical Research Institute, New Lambton, New South Wales, Australia.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Callister', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, The University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Schumacher', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, The University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Haslam', 'Affiliation': 'School of Health Sciences, The University of Newcastle, Callaghan, New South Wales, Australia.'}]",Nutrition & dietetics: the journal of the Dietitians Association of Australia,['10.1111/1747-0080.12638'] 1299,32878963,"DUETTE: a phase II randomized, multicenter study to investigate the efficacy and tolerability of a second maintenance treatment in patients with platinum-sensitive relapsed epithelial ovarian cancer, who have previously received poly(ADP-ribose) polymerase (PARP) inhibitor maintenance treatment.","BACKGROUND With the success of poly(ADP-ribose) polymerase (PARP) inhibitor therapy in the first-line and second-line treatment settings, a new patient population is emerging with platinum-sensitive relapsed ovarian cancer, who have previously received a PARP inhibitor in the maintenance setting and for whom no second maintenance standard of care exists. DUETTE (NCT04239014) will evaluate the combination of ceralasertib (a potent, selective inhibitor of the serine/threonine kinase ataxia telangiectasia and Rad3-related protein (ATR) + olaparib, or olaparib monotherapy, compared with placebo, in this patient population of unmet need. PRIMARY OBJECTIVE The primary objective is to assess the efficacy of ceralasertib + olaparib combination, and olaparib monotherapy, compared with placebo, as second maintenance therapy in platinum-sensitive relapsed ovarian cancer. STUDY HYPOTHESIS This study will test the hypothesis that ceralasertib + olaparib, or olaparib monotherapy, is tolerable, and effective at prolonging progression-free survival compared with placebo. TRIAL DESIGN This is a phase II, multicenter study where patients will be randomized in a 1:1:1 ratio to receive either (Arm 1) ceralasertib + olaparib, (Arm 2) olaparib monotherapy, or (Arm 3) placebo. The olaparib and placebo arms will be double-blinded, whereas the ceralasertib + olaparib arm will be open label. Patients will be stratified according to BRCA status, and response to platinum-based chemotherapy. MAJOR INCLUSION/EXCLUSION CRITERIA Eligible patients will have histologically diagnosed high-grade epithelial ovarian cancer, with platinum-sensitive relapse on, or after, completion of at least 6 months of any prior PARP inhibitor maintenance therapy (a minimum of 12 months is required if the patient received PARP inhibitor maintenance following first-line chemotherapy). If the prior PARP inhibitor used was olaparib then patients must have received treatment without significant toxicity or the need for a permanent dose reduction. Disease relapse in the second-line or third-line setting is allowed. Patients who have received secondary debulking surgery are potentially eligible if they meet all other inclusion criteria. PRIMARY ENDPOINTS The primary endpoint is progression-free survival determined by blinded independent central review according to RECIST 1.1, with sensitivity analysis of progression-free survival using investigator assessments according to RECIST 1.1. SAMPLE SIZE 192 patients. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS December 2022. TRIAL REGISTRATION NCT04239014.",2020,"The primary endpoint is progression-free survival determined by blinded independent central review according to RECIST 1.1, with sensitivity analysis of progression-free survival using investigator assessments according to RECIST 1.1. ","['platinum-sensitive relapsed ovarian cancer', '192 patients', 'Eligible patients will have histologically diagnosed high-grade epithelial ovarian cancer, with platinum-sensitive relapse on, or after, completion of at least 6 months of any prior', 'Patients who have received secondary debulking surgery are potentially eligible if they meet all other inclusion criteria', 'patients with platinum-sensitive relapsed epithelial ovarian cancer, who have previously received poly(ADP-ribose) polymerase (PARP) inhibitor maintenance treatment', 'December 2022']","['olaparib and placebo', 'PARP inhibitor', 'Rad3-related protein (ATR) + olaparib, or olaparib monotherapy', 'poly(ADP-ribose) polymerase (PARP) inhibitor therapy', 'placebo', 'ceralasertib + olaparib, (Arm 2) olaparib monotherapy, or (Arm 3) placebo', 'PARP inhibitor maintenance therapy', 'ceralasertib + olaparib, or olaparib monotherapy', 'ceralasertib + olaparib combination, and olaparib monotherapy']","['progression-free survival', 'Disease relapse', 'efficacy and tolerability']","[{'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1882413', 'cui_str': 'Nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor-containing product'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1882413', 'cui_str': 'Nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor-containing product'}, {'cui': 'C3711837', 'cui_str': 'ATR protein, human'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0277556', 'cui_str': 'Recurrent disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.260806,"The primary endpoint is progression-free survival determined by blinded independent central review according to RECIST 1.1, with sensitivity analysis of progression-free survival using investigator assessments according to RECIST 1.1. ","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'McMullen', 'Affiliation': 'Division of Medical Oncology & Hematology, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Karakasis', 'Affiliation': 'Division of Medical Oncology & Hematology, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Bienvenu', 'Initials': 'B', 'LastName': 'Loembe', 'Affiliation': 'AstraZeneca R&D, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Dean', 'Affiliation': 'AstraZeneca R&D, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Graem', 'Initials': 'G', 'LastName': 'Parr', 'Affiliation': 'AstraZeneca R&D, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Amit M', 'Initials': 'AM', 'LastName': 'Oza', 'Affiliation': 'Division of Medical Oncology & Hematology, Princess Margaret Cancer Centre, Toronto, Ontario, Canada amit.oza@uhn.ca.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001694'] 1300,32862713,Cardiovascular Events and Costs With Home Blood Pressure Telemonitoring and Pharmacist Management for Uncontrolled Hypertension.,"Uncontrolled hypertension is a leading contributor to cardiovascular disease. A cluster-randomized trial in 16 primary care clinics showed that 12 months of home blood pressure telemonitoring and pharmacist management lowered blood pressure more than usual care (UC) for 24 months. We report cardiovascular events (nonfatal myocardial infarction, nonfatal stroke, hospitalized heart failure, coronary revascularization, and cardiovascular death) and costs over 5 years of follow-up. In the telemonitoring intervention (TI group, n=228), there were 15 cardiovascular events (5 myocardial infarction, 4 stroke, 5 heart failure, 1 cardiovascular death) among 10 patients. In UC group (n=222), there were 26 events (11 myocardial infarction, 12 stroke, 3 heart failure) among 19 patients. The cardiovascular composite end point incidence was 4.4% in the TI group versus 8.6% in the UC group (odds ratio, 0.49 [95% CI, 0.21-1.13], P =0.09). Including 2 coronary revascularizations in the TI group and 10 in the UC group, the secondary cardiovascular composite end point incidence was 5.3% in the TI group versus 10.4% in the UC group (odds ratio, 0.48 [95% CI, 0.22-1.08], P =0.08). Microsimulation modeling showed the difference in events far exceeded predictions based on observed blood pressure. Intervention costs (in 2017 US dollars) were $1511 per patient. Over 5 years, estimated event costs were $758 000 in the TI group and $1 538 000 in the UC group for a return on investment of 126% and a net cost savings of about $1900 per patient. Telemonitoring with pharmacist management lowered blood pressure and may have reduced costs by avoiding cardiovascular events over 5 years. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT00781365.",2020,"The cardiovascular composite end point incidence was 4.4% in the TI group versus 8.6% in the UC group (odds ratio, 0.49 [95% CI, 0.21-1.13], P =0.09).","['Uncontrolled Hypertension', '16 primary care clinics showed that 12 months of home blood pressure telemonitoring and pharmacist management lowered blood pressure more than usual care (UC) for 24 months']","['telemonitoring intervention', 'Home Blood Pressure Telemonitoring and Pharmacist Management']","['blood pressure', 'cardiovascular events (nonfatal myocardial infarction, nonfatal stroke, hospitalized heart failure, coronary revascularization, and cardiovascular death) and costs over 5 years of follow-up', 'cardiovascular composite end point incidence', 'estimated event costs', 'Intervention costs', 'secondary cardiovascular composite end point incidence', '15 cardiovascular events (5 myocardial infarction, 4 stroke, 5 heart failure, 1 cardiovascular death']","[{'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0439093', 'cui_str': '>'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",16.0,0.0337506,"The cardiovascular composite end point incidence was 4.4% in the TI group versus 8.6% in the UC group (odds ratio, 0.49 [95% CI, 0.21-1.13], P =0.09).","[{'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Margolis', 'Affiliation': 'From the HealthPartners Institute, Minneapolis, MN (K.L.M., S.P.D., J.S.-H., P.J.O., S.E.A., A.R.B., R.A.N., P.A.P., N.K.T., M.V.M.).'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Dehmer', 'Affiliation': 'From the HealthPartners Institute, Minneapolis, MN (K.L.M., S.P.D., J.S.-H., P.J.O., S.E.A., A.R.B., R.A.N., P.A.P., N.K.T., M.V.M.).'}, {'ForeName': 'JoAnn', 'Initials': 'J', 'LastName': 'Sperl-Hillen', 'Affiliation': 'From the HealthPartners Institute, Minneapolis, MN (K.L.M., S.P.D., J.S.-H., P.J.O., S.E.A., A.R.B., R.A.N., P.A.P., N.K.T., M.V.M.).'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': ""O'Connor"", 'Affiliation': 'From the HealthPartners Institute, Minneapolis, MN (K.L.M., S.P.D., J.S.-H., P.J.O., S.E.A., A.R.B., R.A.N., P.A.P., N.K.T., M.V.M.).'}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Asche', 'Affiliation': 'From the HealthPartners Institute, Minneapolis, MN (K.L.M., S.P.D., J.S.-H., P.J.O., S.E.A., A.R.B., R.A.N., P.A.P., N.K.T., M.V.M.).'}, {'ForeName': 'Anna R', 'Initials': 'AR', 'LastName': 'Bergdall', 'Affiliation': 'From the HealthPartners Institute, Minneapolis, MN (K.L.M., S.P.D., J.S.-H., P.J.O., S.E.A., A.R.B., R.A.N., P.A.P., N.K.T., M.V.M.).'}, {'ForeName': 'Beverly B', 'Initials': 'BB', 'LastName': 'Green', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA (B.B.G.).'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Nyboer', 'Affiliation': 'From the HealthPartners Institute, Minneapolis, MN (K.L.M., S.P.D., J.S.-H., P.J.O., S.E.A., A.R.B., R.A.N., P.A.P., N.K.T., M.V.M.).'}, {'ForeName': 'Pamala A', 'Initials': 'PA', 'LastName': 'Pawloski', 'Affiliation': 'From the HealthPartners Institute, Minneapolis, MN (K.L.M., S.P.D., J.S.-H., P.J.O., S.E.A., A.R.B., R.A.N., P.A.P., N.K.T., M.V.M.).'}, {'ForeName': 'Nicole K', 'Initials': 'NK', 'LastName': 'Trower', 'Affiliation': 'From the HealthPartners Institute, Minneapolis, MN (K.L.M., S.P.D., J.S.-H., P.J.O., S.E.A., A.R.B., R.A.N., P.A.P., N.K.T., M.V.M.).'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Maciosek', 'Affiliation': 'From the HealthPartners Institute, Minneapolis, MN (K.L.M., S.P.D., J.S.-H., P.J.O., S.E.A., A.R.B., R.A.N., P.A.P., N.K.T., M.V.M.).'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.15492'] 1301,32866454,"An Electronically delivered, Patient-activation tool for Intensification of medications for Chronic Heart Failure with reduced ejection fraction: Rationale and design of the EPIC-HF trial.","BACKGROUND Heart failure with reduced ejection fraction (HFrEF) benefits from initiation and intensification of multiple pharmacotherapies. Unfortunately, there are major gaps in the routine use of these drugs. Without novel approaches to improve prescribing, the cumulative benefits of HFrEF treatment will be largely unrealized. Direct-to-consumer marketing and shared decision making reflect a culture where patients are increasingly involved in treatment choices, creating opportunities for prescribing interventions that engage patients. HYPOTHESIS Encouraging patients to engage providers in HFrEF prescribing decisions will improve the use of guideline-directed medical therapies. DESIGN The Electronically delivered, Patient-activation tool for Intensification of Chronic medications for Heart Failure with reduced ejection fraction (EPIC-HF) trial randomizes patients with HFrEF to usual care versus patient-activation tools-a 3-minute video and 1-page checklist-delivered prior to cardiology clinic visits that encourage patients to work collaboratively with their clinicians to intensify HFrEF prescribing. The study assesses the effectiveness of the EPIC-HF intervention to improve guideline-directed medical therapy in the month after its delivery while using an implementation design to also understand the reach, adoption, implementation, and maintenance of this approach within the context of real-world care delivery. Study enrollment was completed in January 2020, with a total 305 patients. Baseline data revealed significant opportunities, with <1% of patients on optimal HFrEF medical therapy. SUMMARY The EPIC-HF trial assesses the implementation, effectiveness, and safety of patient engagement in HFrEF prescribing decisions. If successful, the tool can be easily disseminated and may inform similar interventions for other chronic conditions.",2020,"The Electronically delivered, Patient-activation tool for Intensification of Chronic medications for Heart Failure with reduced ejection fraction (EPIC-HF) trial randomizes patients with HFrEF to usual care versus patient activation tools-a 3-minute video and 1-page checklist-delivered prior to cardiology clinic visits that encourage patients to work collaboratively with their clinicians to intensify HFrEF prescribing.","['Study enrollment was completed January 2020, with a total 305 patients', 'chronic heart failure with reduced ejection fraction', 'Heart Failure with reduced ejection fraction (EPIC-HF) trial randomizes patients with HFrEF to usual care versus patient']","['activation tools-a 3-minute video and 1-page checklist-delivered prior to cardiology clinic visits', 'EPIC-HF intervention']",[],"[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4280934', 'cui_str': 'Reduced ejection fraction co-occurrent and due to chronic heart failure'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C1273342', 'cui_str': 'Epithelial cell count'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0013862', 'cui_str': 'Polyacrylamide gel electrophoresis'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C3810847', 'cui_str': 'Cardiology clinic'}, {'cui': 'C1273342', 'cui_str': 'Epithelial cell count'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0376458,"The Electronically delivered, Patient-activation tool for Intensification of Chronic medications for Heart Failure with reduced ejection fraction (EPIC-HF) trial randomizes patients with HFrEF to usual care versus patient activation tools-a 3-minute video and 1-page checklist-delivered prior to cardiology clinic visits that encourage patients to work collaboratively with their clinicians to intensify HFrEF prescribing.","[{'ForeName': 'Grace E', 'Initials': 'GE', 'LastName': 'Venechuk', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Prateeti', 'Initials': 'P', 'LastName': 'Khazanie', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Page', 'Affiliation': 'University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences Aurora, CO.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Knoepke', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Helmkamp', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Pamela N', 'Initials': 'PN', 'LastName': 'Peterson', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO; Denver Health Medical Center, Denver, CO.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Pierce', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Jocelyn S', 'Initials': 'JS', 'LastName': 'Thompson', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'UCHealth Memorial Hospital, Colorado Springs, CO.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Strader', 'Affiliation': 'UCHealth Memorial Hospital, Colorado Springs, CO.'}, {'ForeName': 'Tristan J', 'Initials': 'TJ', 'LastName': 'Dow', 'Affiliation': 'UCHealth Poudre Valley Hospital, Loveland, CO.'}, {'ForeName': 'Lance', 'Initials': 'L', 'LastName': 'Richards', 'Affiliation': 'UCHealth Poudre Valley Hospital, Loveland, CO.'}, {'ForeName': 'Katy E', 'Initials': 'KE', 'LastName': 'Trinkley', 'Affiliation': 'University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences Aurora, CO.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Kao', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Colleen K', 'Initials': 'CK', 'LastName': 'McIlvennan', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Magid', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Buttrick', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Matlock', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Larry A', 'Initials': 'LA', 'LastName': 'Allen', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO. Electronic address: larry.allen@cuanschutz.edu.'}]",American heart journal,['10.1016/j.ahj.2020.08.013'] 1302,32869511,Youth-friendly services and a mobile phone application to promote adherence to pre-exposure prophylaxis among adolescent men who have sex with men and transgender women at-risk for HIV in Thailand: a randomized control trial.,"INTRODUCTION Strategies are needed to curb the increasing HIV incidence in young men who have sex with men (YMSM) and transgender women (YTGW) worldwide. We assessed the impact of youth-friendly services (YFS) and a mobile phone application (app) on adherence to pre-exposure prophylaxis (PrEP) in YMSM and YTGW in Thailand. METHODS A randomized control trial was conducted in YMSM and YTGW aged 15 to 19 years. Participants were provided daily oral tenofovir disoproxil fumerate/emtricitabine (TDF/FTC), condoms and randomized to receive either YFS or YFS plus a PrEP app (YFS + APP), whose features included self-assessment of HIV acquisition risk, point rewards and reminders for PrEP and clinic appointments. Clinic visits occurred at zero, one, three and six months and telephone contact at two, four and five months. HIV testing was performed at every clinic visit. PrEP adherence was evaluated with intracellular tenofovir diphosphate (TFV-DP) concentrations in dried blood spot (DBS) samples at months 3 and 6. The primary endpoint assessed was ""PrEP adherence"" defined as TFV-DP DBS concentrations ≥700 fmol/punch (equivalent to ≥4 doses of TDF/week). RESULTS Between March 2018 and June 2019, 489 adolescents were screened at three centres in Bangkok. Twenty-seven (6%) adolescents tested positive for HIV and 200 (41%) adolescents participated in the study. Of these, 147 were YMSM (74%) and 53 YTGW (26%). At baseline, median age was 18 years (IQR 17 to 19), 66% reported inconsistent condom use in the past month. Sexually transmitted infection prevalence was 23%. Retention at six months was 73%. In the YFS + APP arm, median app use duration was three months (IQR 1 to 5). PrEP adherence at month 3 was 51% in YFS and 54% in YFS + APP (p-value 0.64) and at month 6 was 44% in YFS and 49% in YFS + APP (p-value 0.54). No HIV seroconversions occurred during 75 person years of follow-up. CONCLUSIONS Youth-friendly PrEP services enabled good adherence among half of adolescent PrEP users. However, the mobile phone application tested did not provide additional PrEP adherence benefit in this randomized trial. Adolescent risk behaviours are dynamic and require adaptive programmes that focus on ""prevention-effective adherence.""",2020,PrEP adherence at month 3 was 51% in YFS and 54% in YFS + APP (p-value 0.64) and at month 6 was 44% in YFS and 49% in YFS + APP (p-value 0.54).,"['Twenty-seven (6%) adolescents tested positive for HIV and 200 (41%) adolescents participated in the study', 'YMSM and YTGW aged 15 to 19\xa0years', 'Between March 2018 and June 2019', 'adolescent men who have sex with men and transgender women at-risk for HIV in Thailand', '489 adolescents were screened at three centres in Bangkok', 'young men who have sex with men (YMSM) and transgender women (YTGW) worldwide']","['mobile phone application', 'youth-friendly services (YFS) and a mobile phone application (app', 'YFS or YFS plus a PrEP app (YFS\xa0+\xa0APP', 'oral tenofovir disoproxil fumerate/emtricitabine (TDF/FTC']","['HIV seroconversions', 'Clinic visits', 'PrEP adherence', 'PrEP adherence"" defined as TFV-DP DBS concentrations ≥700\xa0fmol/punch (equivalent to ≥4 doses of TDF/week', 'intracellular tenofovir diphosphate (TFV-DP) concentrations']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0963398', 'cui_str': 'tenofovir disoproxil'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C3712637', 'cui_str': 'tenofovir diphosphate'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439195', 'cui_str': 'fmol'}, {'cui': 'C0182555', 'cui_str': 'Punch'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}]",489.0,0.110985,PrEP adherence at month 3 was 51% in YFS and 54% in YFS + APP (p-value 0.64) and at month 6 was 44% in YFS and 49% in YFS + APP (p-value 0.54).,"[{'ForeName': 'Wipaporn Natalie', 'Initials': 'WN', 'LastName': 'Songtaweesin', 'Affiliation': 'Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Surinda', 'Initials': 'S', 'LastName': 'Kawichai', 'Affiliation': 'Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Nittaya', 'Initials': 'N', 'LastName': 'Phanuphak', 'Affiliation': 'Institute of HIV Research and Innovation, Bangkok, Thailand.'}, {'ForeName': 'Tim R', 'Initials': 'TR', 'LastName': 'Cressey', 'Affiliation': 'PHPT/IRD UMI 174, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Prissana', 'Initials': 'P', 'LastName': 'Wongharn', 'Affiliation': 'Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Chutima', 'Initials': 'C', 'LastName': 'Saisaengjan', 'Affiliation': 'Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Tanat', 'Initials': 'T', 'LastName': 'Chinbunchorn', 'Affiliation': 'Institute of HIV Research and Innovation, Bangkok, Thailand.'}, {'ForeName': 'Surang', 'Initials': 'S', 'LastName': 'Janyam', 'Affiliation': 'The Service Workers IN Group Foundation, Bangkok, Thailand.'}, {'ForeName': 'Danai', 'Initials': 'D', 'LastName': 'Linjongrat', 'Affiliation': 'Rainbow Sky Association, Bangkok, Thailand.'}, {'ForeName': 'Thanyawee', 'Initials': 'T', 'LastName': 'Puthanakit', 'Affiliation': 'Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the International AIDS Society,['10.1002/jia2.25564'] 1303,32869527,"""If it is left, it becomes easy for me to get tested"": Use of oral self-tests and community health workers to maximize the potential of home-based HIV testing among adolescents in Lesotho.","INTRODUCTION Home-based HIV testing fails to reach high coverage among adolescents and young adults (AYA), mainly because they are often absent during the day of home-based testing. ADORE (ADolescent ORal tEsting) is a mixed-method nested study among AYA in rural Lesotho, measuring the effect of home-based secondary distribution of oral HIV self-tests (HIVST) on coverage, as well as exploring how AYA perceive this HIV self-testing model. METHODS ADORE study was nested in a cluster-randomized trial. In intervention village-clusters, oral HIVST were left for household members who were absent or declined testing during a testing campaign. One present household member was trained on HIVST use. Distributed HIVST were followed up by village health workers (VHW). In control clusters no self-tests were distributed. The quantitative outcome was testing coverage among AYA (age 12 to 24) within 120 days, defined as a confirmed HIV test result or known status, using adjusted random-effects logistic regression on the intention-to-treat population. Qualitatively, we conducted in-depth interviews among both AYA who used and did not use the distributed HIVST. RESULTS From July 2018 to December 2018, 49 and 57 villages with 1471 and 1620 consenting households and 1236 and 1445 AYA in the control and intervention arm, respectively, were enrolled. On the day of the home-visit, a testing coverage of 37% (461/1236) and 41% (596/1445) in the control and the intervention arm, respectively, were achieved. During the 120 days follow-up period, an additional 23 and 490 AYA in control and intervention clusters, respectively, knew their status. This resulted in a testing coverage of 484/1236 (39%) in the control versus 1086/1445 (75%) in the intervention arm (aOR 8.80 [95% CI 5.81 to 13.32]; p < 0.001). 21 interviews were performed. Personal assistance after the secondary distribution emerged as a key theme and VHWs were generally seen as a trusted cadre. CONCLUSIONS Secondary distribution of HIVST for AYA absent or refusing to test during home-based testing in Lesotho resulted in an absolute 36% increase in coverage. Distribution should, however, go along with clear instructions on the use of the HIVST and a possibility to easily access more personal support.",2020,This resulted in a testing coverage of 484/1236 (39%) in the control versus 1086/1445 (75%) in the intervention arm (aOR 8.80 [95% CI 5.81 to 13.32]; p < 0.001).,"['From July 2018 to December 2018, 49 and 57 villages with 1471 and 1620 consenting households and 1236 and 1445 AYA in the control and intervention arm, respectively, were enrolled']",['HIVST'],['Personal assistance'],"[{'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]",21.0,0.0360762,This resulted in a testing coverage of 484/1236 (39%) in the control versus 1086/1445 (75%) in the intervention arm (aOR 8.80 [95% CI 5.81 to 13.32]; p < 0.001).,"[{'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Amstutz', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Mathebe', 'Initials': 'M', 'LastName': 'Kopo', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Thabo I', 'Initials': 'TI', 'LastName': 'Lejone', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Lefu', 'Initials': 'L', 'LastName': 'Khesa', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Mpho', 'Initials': 'M', 'LastName': 'Kao', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Muhairwe', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Tracy R', 'Initials': 'TR', 'LastName': 'Glass', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Niklaus D', 'Initials': 'ND', 'LastName': 'Labhardt', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}]",Journal of the International AIDS Society,['10.1002/jia2.25563'] 1304,32876694,Association Between Administration of Systemic Corticosteroids and Mortality Among Critically Ill Patients With COVID-19: A Meta-analysis.,"Importance Effective therapies for patients with coronavirus disease 2019 (COVID-19) are needed, and clinical trial data have demonstrated that low-dose dexamethasone reduced mortality in hospitalized patients with COVID-19 who required respiratory support. Objective To estimate the association between administration of corticosteroids compared with usual care or placebo and 28-day all-cause mortality. Design, Setting, and Participants Prospective meta-analysis that pooled data from 7 randomized clinical trials that evaluated the efficacy of corticosteroids in 1703 critically ill patients with COVID-19. The trials were conducted in 12 countries from February 26, 2020, to June 9, 2020, and the date of final follow-up was July 6, 2020. Pooled data were aggregated from the individual trials, overall, and in predefined subgroups. Risk of bias was assessed using the Cochrane Risk of Bias Assessment Tool. Inconsistency among trial results was assessed using the I2 statistic. The primary analysis was an inverse variance-weighted fixed-effect meta-analysis of overall mortality, with the association between the intervention and mortality quantified using odds ratios (ORs). Random-effects meta-analyses also were conducted (with the Paule-Mandel estimate of heterogeneity and the Hartung-Knapp adjustment) and an inverse variance-weighted fixed-effect analysis using risk ratios. Exposures Patients had been randomized to receive systemic dexamethasone, hydrocortisone, or methylprednisolone (678 patients) or to receive usual care or placebo (1025 patients). Main Outcomes and Measures The primary outcome measure was all-cause mortality at 28 days after randomization. A secondary outcome was investigator-defined serious adverse events. Results A total of 1703 patients (median age, 60 years [interquartile range, 52-68 years]; 488 [29%] women) were included in the analysis. Risk of bias was assessed as ""low"" for 6 of the 7 mortality results and as ""some concerns"" in 1 trial because of the randomization method. Five trials reported mortality at 28 days, 1 trial at 21 days, and 1 trial at 30 days. There were 222 deaths among the 678 patients randomized to corticosteroids and 425 deaths among the 1025 patients randomized to usual care or placebo (summary OR, 0.66 [95% CI, 0.53-0.82]; P < .001 based on a fixed-effect meta-analysis). There was little inconsistency between the trial results (I2 = 15.6%; P = .31 for heterogeneity) and the summary OR was 0.70 (95% CI, 0.48-1.01; P = .053) based on the random-effects meta-analysis. The fixed-effect summary OR for the association with mortality was 0.64 (95% CI, 0.50-0.82; P < .001) for dexamethasone compared with usual care or placebo (3 trials, 1282 patients, and 527 deaths), the OR was 0.69 (95% CI, 0.43-1.12; P = .13) for hydrocortisone (3 trials, 374 patients, and 94 deaths), and the OR was 0.91 (95% CI, 0.29-2.87; P = .87) for methylprednisolone (1 trial, 47 patients, and 26 deaths). Among the 6 trials that reported serious adverse events, 64 events occurred among 354 patients randomized to corticosteroids and 80 events occurred among 342 patients randomized to usual care or placebo. Conclusions and Relevance In this prospective meta-analysis of clinical trials of critically ill patients with COVID-19, administration of systemic corticosteroids, compared with usual care or placebo, was associated with lower 28-day all-cause mortality.",2020,"There was little inconsistency between the trial results (I2 = 15.6%; P = .31 for heterogeneity) and the summary OR was 0.70 (95% CI, 0.48-1.01; P = .053) based on the random-effects meta-analysis.","['patients with coronavirus disease 2019 (COVID-19', 'hospitalized patients with COVID-19 who required respiratory support', '12 countries from February 26, 2020, to June 9, 2020, and the date of final follow-up was July 6, 2020', '1703 patients (median age, 60 years [interquartile range, 52-68 years]; 488 [29%] women) were included in the analysis', 'critically ill patients with COVID-19, administration of systemic corticosteroids, compared with', '222 deaths among the 678 patients randomized to corticosteroids and 425 deaths among the 1025 patients randomized to', 'Critically Ill Patients With COVID-19', '1703 critically ill patients with COVID-19', '1025 patients']","['corticosteroids', 'systemic dexamethasone, hydrocortisone, or methylprednisolone (678 patients) or to receive usual care or placebo', 'methylprednisolone', 'usual care or placebo', 'dexamethasone', 'placebo', 'hydrocortisone']","['cause mortality', 'investigator-defined serious adverse events', 'mortality quantified using odds ratios (ORs', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3844105', 'cui_str': '425'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",1703.0,0.618646,"There was little inconsistency between the trial results (I2 = 15.6%; P = .31 for heterogeneity) and the summary OR was 0.70 (95% CI, 0.48-1.01; P = .053) based on the random-effects meta-analysis.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Jonathan A C', 'Initials': 'JAC', 'LastName': 'Sterne', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, England.'}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Murthy', 'Affiliation': 'Department of Pediatrics, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Janet V', 'Initials': 'JV', 'LastName': 'Diaz', 'Affiliation': 'Clinical Unit, Health Emergencies Programme, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Arthur S', 'Initials': 'AS', 'LastName': 'Slutsky', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Villar', 'Affiliation': 'Research Unit, Hospital Universitario Dr Negrín, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Derek C', 'Initials': 'DC', 'LastName': 'Angus', 'Affiliation': 'Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Djillali', 'Initials': 'D', 'LastName': 'Annane', 'Affiliation': 'Department of Intensive Care, Raymond Poincaré Hospital (APHP), School of Medicine Simone Veil, University Paris Saclay-UVSQ, Paris, France.'}, {'ForeName': 'Luciano Cesar Pontes', 'Initials': 'LCP', 'LastName': 'Azevedo', 'Affiliation': 'Hospital Sírio-Libanês, São Paulo, Brazil.'}, {'ForeName': 'Otavio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': 'Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Alexandre B', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'HCor Research Insitute, São Paulo, Brazil.'}, {'ForeName': 'Pierre-Francois', 'Initials': 'PF', 'LastName': 'Dequin', 'Affiliation': 'Médecine Intensive-Réanimation, INSERM CIC1415, CHRU de Tours, Tours, France.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Du', 'Affiliation': 'Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Emberson', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, England.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fisher', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, Faculty of Population Health Sciences, University College London, London, England.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Giraudeau', 'Affiliation': 'CIC INSERM 1415-CHRU de Tours, Tours, France.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Gordon', 'Affiliation': 'Division of Anaesthetics, Pain Medicine and Intensive Care, Imperial College London, London, England.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Granholm', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Green', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Haynes', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, England.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Heming', 'Affiliation': 'Department of Intensive Care, Raymond Poincaré Hospital (APHP), School of Medicine Simone Veil, University Paris Saclay-UVSQ, Paris, France.'}, {'ForeName': 'Julian P T', 'Initials': 'JPT', 'LastName': 'Higgins', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, England.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Horby', 'Affiliation': 'Nuffield Department of Medicine, University of Oxford, Oxford, England.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Landray', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, England.'}, {'ForeName': 'Amelie', 'Initials': 'A', 'LastName': 'Le Gouge', 'Affiliation': 'CIC INSERM 1415-CHRU de Tours, Tours, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Leclerc', 'Affiliation': 'CIC INSERM 1415-CHRU de Tours, Tours, France.'}, {'ForeName': 'Wei Shen', 'Initials': 'WS', 'LastName': 'Lim', 'Affiliation': 'Respiratory Medicine Department, Nottingham University Hospitals NHS Trust, Nottingham, England.'}, {'ForeName': 'Flávia R', 'Initials': 'FR', 'LastName': 'Machado', 'Affiliation': 'Anesthesiology, Pain, and Intensive Care Department, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'McArthur', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Ferhat', 'Initials': 'F', 'LastName': 'Meziani', 'Affiliation': 'Hôpitaux Universitaires de Strasbourg, Service de Médecine Intensive Réanimation, Nouvel Hôpital Civil, Strasbourg, France.'}, {'ForeName': 'Morten Hylander', 'Initials': 'MH', 'LastName': 'Møller', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Perner', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Marie Warrer', 'Initials': 'MW', 'LastName': 'Petersen', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Savovic', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, England.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Tomazini', 'Affiliation': 'Hospital Sírio-Libanês, São Paulo, Brazil.'}, {'ForeName': 'Viviane C', 'Initials': 'VC', 'LastName': 'Veiga', 'Affiliation': 'BP-A Beneficência Portuguesa de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Webb', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Marshall', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}]",JAMA,['10.1001/jama.2020.17023'] 1305,32881550,Association between therapist attunement to patient outcome expectation and worry reduction in two therapies for generalized anxiety disorder.,"Patients' higher psychotherapy outcome expectation (OE) correlates with improvement. Thus, it seems important that therapists attune to this belief, both in the moment and over time, to capitalize on its value when higher or respond to its potential risk when lower. Conceptually, attunement can have different guises, including the extent to which therapists (a) accurately estimate their patients' momentary OE level (low directional discrepancy), (b) become more accurate in estimating OE over time (convergence), (c) accurately track shifts in their patients' OE (temporal congruence), and (d) become more temporally congruent over time (alignment). To date, though, little is known empirically about therapist attunement to patient OE. Thus, we examined the presence of attunement indices and their relation to posttreatment outcome. Data derived from a randomized trial that compared cognitive-behavioral therapy (CBT; n = 43) to CBT plus motivational interviewing ( n = 42) for patients with generalized anxiety disorder. After each session, patients rated their OE, and therapists estimated their patients' OE. Patients rated worry at baseline and posttreatment. Dyadic multilevel modeling revealed that across both treatments, therapists were directionally discrepant in that they underestimated patients' OE ( p < .001), which did not change over time (no average convergence/divergence pattern; p = .43). Additionally, therapists exhibited temporal congruence with patients' OE ( p < .001) and became more aligned with this rating over time ( p = .008). Only greater OE convergence, when it occurred, predicted lower worry ( p = .04). A therapist's increasingly accurate empathy about their patients' OE may be therapeutic. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"Additionally, therapists exhibited temporal congruence with patients' OE ( p < .001) and became more aligned with this rating over time ( p = .008).","['generalized anxiety disorder', 'patients with generalized anxiety disorder']","['cognitive-behavioral therapy (CBT', 'CBT plus motivational interviewing']",['OE convergence'],"[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0443193', 'cui_str': 'Convergence'}]",,0.0333667,"Additionally, therapists exhibited temporal congruence with patients' OE ( p < .001) and became more aligned with this rating over time ( p = .008).","[{'ForeName': 'Alice E', 'Initials': 'AE', 'LastName': 'Coyne', 'Affiliation': 'Department of Psychological and Brain Sciences.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Constantino', 'Affiliation': 'Department of Psychological and Brain Sciences.'}, {'ForeName': 'Averi N', 'Initials': 'AN', 'LastName': 'Gaines', 'Affiliation': 'Department of Psychological and Brain Sciences.'}, {'ForeName': 'Holly B', 'Initials': 'HB', 'LastName': 'Laws', 'Affiliation': 'Department of Psychological and Brain Sciences.'}, {'ForeName': 'Henny A', 'Initials': 'HA', 'LastName': 'Westra', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Martin M', 'Initials': 'MM', 'LastName': 'Antony', 'Affiliation': 'Department of Psychology.'}]",Journal of counseling psychology,['10.1037/cou0000457'] 1306,32892758,Imagery rescripting and eye movement desensitisation and reprocessing as treatment for adults with post-traumatic stress disorder from childhood trauma: randomised clinical trial.,"BACKGROUND Investigation of treatments that effectively treat adults with post-traumatic stress disorder from childhood experiences (Ch-PTSD) and are well tolerated by patients is needed to improve outcomes for this population. AIMS The purpose of this study was to compare the effectiveness of two trauma-focused treatments, imagery rescripting (ImRs) and eye movement desensitisation and reprocessing (EMDR), for treating Ch-PTSD. METHOD We conducted an international, multicentre, randomised clinical trial, recruiting adults with Ch-PTSD from childhood trauma before 16 years of age. Participants were randomised to treatment condition and assessed by blind raters at multiple time points. Participants received up to 12 90-min sessions of either ImRs or EMDR, biweekly. RESULTS A total of 155 participants were included in the final intent-to-treat analysis. Drop-out rates were low, at 7.7%. A generalised linear mixed model of repeated measures showed that observer-rated post-traumatic stress disorder (PTSD) symptoms significantly decreased for both ImRs (d = 1.72) and EMDR (d = 1.73) at the 8-week post-treatment assessment. Similar results were seen with secondary outcome measures and self-reported PTSD symptoms. There were no significant differences between the two treatments on any standardised measure at post-treatment and follow-up. CONCLUSIONS ImRs and EMDR treatments were found to be effective in treating PTSD symptoms arising from childhood trauma, and in reducing other symptoms such as depression, dissociation and trauma-related cognitions. The low drop-out rates suggest that the treatments were well tolerated by participants. The results from this study provide evidence for the use of trauma-focused treatments for Ch-PTSD.",2020,"There were no significant differences between the two treatments on any standardised measure at post-treatment and follow-up. ","['A total of 155 participants were included in the final intent-to-treat analysis', 'adults with post-traumatic stress disorder from childhood trauma', 'adults with Ch-PTSD from childhood trauma before 16 years of age', 'adults with post-traumatic stress disorder from childhood experiences (Ch-PTSD']","['Imagery rescripting and eye movement desensitisation and reprocessing as treatment', 'imagery rescripting (ImRs) and eye movement desensitisation and reprocessing (EMDR', 'ImRs or EMDR, biweekly']","['self-reported PTSD symptoms', 'observer-rated post-traumatic stress disorder (PTSD) symptoms']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}]",155.0,0.104754,"There were no significant differences between the two treatments on any standardised measure at post-treatment and follow-up. ","[{'ForeName': 'Katrina L', 'Initials': 'KL', 'LastName': 'Boterhoven de Haan', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Western Australia, Australia.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Lee', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Western Australia, Australia.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Fassbinder', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Lübeck, Germany.'}, {'ForeName': 'Saskia M', 'Initials': 'SM', 'LastName': 'van Es', 'Affiliation': 'PsyQ Amsterdam, Parnassia Group, the Netherlands.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Menninga', 'Affiliation': 'PsyQ Beverwijk, Parnassia Group, the Netherlands.'}, {'ForeName': 'Marie-Louise', 'Initials': 'ML', 'LastName': 'Meewisse', 'Affiliation': 'Abate, Centre of Expertise in Anxiety and Psychotrauma, the Netherlands.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Rijkeboer', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, the Netherlands.'}, {'ForeName': 'Margriet', 'Initials': 'M', 'LastName': 'Kousemaker', 'Affiliation': 'Amstelveen, Sinai Centrum, the Netherlands.'}, {'ForeName': 'Arnoud', 'Initials': 'A', 'LastName': 'Arntz', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, the Netherlands.'}]",The British journal of psychiatry : the journal of mental science,['10.1192/bjp.2020.158'] 1307,32867226,South Indian Cuisine with Low Glycemic Index Ingredients Reduces Cardiovascular Risk Factors in Subjects with Type 2 Diabetes.,"Background : Inflammation is considered as a predictor of cardiovascular diseases in type 2 diabetes mellitus. No previous studies have investigated the effect of low glycemic index (LGI) recipes of South Indian cuisine on the risk factors of cardiovascular disease in patients with diabetes. Aim : The aim of this randomized controlled trial was to evaluate the improvement in cardiovascular risk factors and blood glucose control, in patients with type 2 diabetes, after intervention with recipes of Kerala cuisine, from locally available whole grain cereals, low in glycemic index. Method : This was a prospective and randomized controlled study that was conducted over a period of 24 weeks. A total of 80 participants were recruited from the Department of Endocrinology and Diabetes Outpatient in Kerala, South India. All 80 patients had type 2 diabetes, and were aged between 35 and 65 years. Participants were randomly assigned and advised to follow either a LGI diet plan ( n = 40) or their usual diet, which served as a control group ( n = 40). The advice was reinforced throughout the study period. Anthropometric, biochemical parameters which included glycemic and cardio-metabolic parameters were measured according to standard procedures. T-tests were conducted to compare the differences between intervention and control groups, and the Pearson correlation coefficient was used to evaluate associations between the variables. Results : There were significant differences ( p < 0.05) between the intervention and control groups with respect to weight, HbA1c, insulin, triglycerides, Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), high sensitivity C-reactive protein (hs-CRP) and apolipoprotein B (ApoB). There was also a positive correlation between weight and blood glucose variables. ApoB was positively correlated with lipid profile and insulin levels. Conclusions : The long-term implementation of LGI diet of Kerala cuisine has been found to promote weight loss, enhance insulin sensitivity and reduce the cardiovascular risk.",2020,"There were significant differences ( p < 0.05) between the intervention and control groups with respect to weight, HbA1c, insulin, triglycerides, Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), high sensitivity C-reactive protein (hs-CRP) and apolipoprotein B (ApoB).","['type 2 diabetes mellitus', 'Subjects with Type 2 Diabetes', '80 participants were recruited from the Department of Endocrinology and Diabetes Outpatient in Kerala, South India', 'patients with diabetes', 'patients with type 2 diabetes, after intervention with recipes of Kerala cuisine, from locally available whole grain cereals, low in glycemic index', 'All 80 patients had type 2 diabetes, and were aged between 35 and 65 years']","['Low Glycemic Index Ingredients', 'LGI diet plan ( n = 40) or their usual diet']","['cardiovascular risk factors and blood glucose control', 'weight, HbA1c, insulin, triglycerides, Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), high sensitivity C-reactive protein (hs-CRP) and apolipoprotein B (ApoB', 'Cardiovascular Risk Factors', 'weight and blood glucose variables', 'lipid profile and insulin levels']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0014137', 'cui_str': 'Endocrinology'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0443018', 'cui_str': 'Kerala'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0600194', 'cui_str': 'Recipes'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C4046096', 'cui_str': 'Whole Grain Cereals'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}]",80.0,0.0386707,"There were significant differences ( p < 0.05) between the intervention and control groups with respect to weight, HbA1c, insulin, triglycerides, Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), high sensitivity C-reactive protein (hs-CRP) and apolipoprotein B (ApoB).","[{'ForeName': 'Nivedita', 'Initials': 'N', 'LastName': 'Pavithran', 'Affiliation': 'Department of Clinical Nutrition, Amrita Institute of Medical Sciences and Research Centre, Amrita Vishwa Vidyapeetham, Kochi, Kerala 682041, India.'}, {'ForeName': 'Harish', 'Initials': 'H', 'LastName': 'Kumar', 'Affiliation': 'Department of Endocrinology, Amrita Institute of Medical Sciences and Research Centre, Amrita Vishwa Vidyapeetham, Kochi, Kerala 682041, India.'}, {'ForeName': 'Arun Somasekharan', 'Initials': 'AS', 'LastName': 'Menon', 'Affiliation': 'Department of Endocrinology, Amrita Institute of Medical Sciences and Research Centre, Amrita Vishwa Vidyapeetham, Kochi, Kerala 682041, India.'}, {'ForeName': 'Gopala Krishna', 'Initials': 'GK', 'LastName': 'Pillai', 'Affiliation': 'Department of General Medicine, Amrita Institute of Medical Sciences and Research Centre, Amrita Vishwa Vidyapeetham, Kochi, Kerala 682041, India.'}, {'ForeName': 'Karimassery Ramaiyer', 'Initials': 'KR', 'LastName': 'Sundaram', 'Affiliation': 'Department of Biostatistics, Amrita Institute of Medical Sciences and Research Centre, Amrita Vishwa Vidyapeetham, Kochi, Kerala 682041, India.'}, {'ForeName': 'Omorogieva', 'Initials': 'O', 'LastName': 'Ojo', 'Affiliation': 'School of Health Sciences, Faculty of Education, Health and Human Sciences, University of Greenwich, London SE9 2UG, UK.'}]",International journal of environmental research and public health,['10.3390/ijerph17176232'] 1308,32883493,Role of metastasectomy for liver metastasis in stage IV anal cancer.,"INTRODUCTION There is a paucity of data on the role of metastasectomy for metastatic anal cancer on survival outcomes. We aim to define the role of metastasectomy in stage IV anal cancer. METHODS National Cancer Database (NCDB) from 2004 to 2014 was accessed to include patients with metastatic anal cancer, excluding adenocarcinoma, neuroendocrine, and 'other' histologies. We compared patients undergoing metastasectomy (n = 165) to those who did not have metastasectomy (n = 2093) by age, sex, cancer grade, and site of metastasis, including metastasis to bone, liver, and lung, using chi-square analysis. The primary outcome was overall survival. RESULTS Patients had equal distribution of metastatic sites between those who underwent metastasectomy versus no metastasectomy: bone (7.64% vs 4.85%, p = 0.22), brain (0.24% vs 0%, p = 1.0), liver (23.22% vs 29.70%, p = 0.07), and lung (11.85% vs 9.09%, p = 0.38). Survival following metastasectomy was increased at one year (71% vs. 61%, p = 0.016), two years (50% vs. 38%, p = 0.014), and five years (30% vs. 19%, p = 0.025). Median overall survival was increased (23 months vs. 16 months; p = 0.015) for patients with metastasectomy. Survival increases were demonstrated only in the group with liver metastasis undergoing metastasectomy. When stratifying for liver metastases only, median overall survival time was further increased (34 months vs. 16 months; p < 0.0001) following metastasectomy. CONCLUSION These results demonstrate a survival benefit for hepatic metastasectomy in stage IV anal cancer. Our findings demonstrate a potential survival benefit in highly select patients with metastatic anal cancer to the liver. These findings support further investigation in a randomized clinical trial to delineate these findings.",2021,Median overall survival was increased (23 months vs. 16 months; p = 0.015) for patients with metastasectomy.,"['liver metastasis in stage IV anal cancer', 'patients with metastatic anal cancer to the liver', ""National Cancer Database (NCDB) from 2004 to 2014 was accessed to include patients with metastatic anal cancer, excluding adenocarcinoma, neuroendocrine, and 'other' histologies"", 'patients undergoing metastasectomy (n\xa0=\xa0165) to those who did not have metastasectomy (n\xa0=\xa02093) by age, sex, cancer grade, and site of metastasis, including metastasis to bone, liver, and lung, using chi-square analysis']",[],"['equal distribution of metastatic sites', 'overall survival', 'median overall survival time', 'Median overall survival', 'Survival increases', 'Survival following metastasectomy']","[{'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0861424', 'cui_str': 'Anal cancer stage IV'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1369136', 'cui_str': 'Anal cancer metastatic'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0027912', 'cui_str': 'Neuroendocrine System'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C2363923', 'cui_str': 'Metastasectomy'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0153690', 'cui_str': 'Secondary malignant neoplasm of bone'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0376586', 'cui_str': 'Life-Breath (Philosophy)'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",[],"[{'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C2363923', 'cui_str': 'Metastasectomy'}]",2093.0,0.136151,Median overall survival was increased (23 months vs. 16 months; p = 0.015) for patients with metastasectomy.,"[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Goldner', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, Cooper University Hospital, 3 Cooper Plaza, Suite 411, Camden, NJ, 08103, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Platoff', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, Cooper University Hospital, 3 Cooper Plaza, Suite 411, Camden, NJ, 08103, USA.'}, {'ForeName': 'Avril', 'Initials': 'A', 'LastName': 'Betances', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, Cooper University Hospital, 3 Cooper Plaza, Suite 411, Camden, NJ, 08103, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'De Leo', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, Cooper University Hospital, 3 Cooper Plaza, Suite 411, Camden, NJ, 08103, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gaughan', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, Cooper University Hospital, 3 Cooper Plaza, Suite 411, Camden, NJ, 08103, USA.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Hageboutros', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, Cooper University Hospital, 3 Cooper Plaza, Suite 411, Camden, NJ, 08103, USA.'}, {'ForeName': 'Umur', 'Initials': 'U', 'LastName': 'Atabek', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, Cooper University Hospital, 3 Cooper Plaza, Suite 411, Camden, NJ, 08103, USA.'}, {'ForeName': 'Francis R', 'Initials': 'FR', 'LastName': 'Spitz', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, Cooper University Hospital, 3 Cooper Plaza, Suite 411, Camden, NJ, 08103, USA.'}, {'ForeName': 'Young K', 'Initials': 'YK', 'LastName': 'Hong', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, Cooper University Hospital, 3 Cooper Plaza, Suite 411, Camden, NJ, 08103, USA. Electronic address: Hong-young@cooperhealth.edu.'}]",American journal of surgery,['10.1016/j.amjsurg.2020.08.016'] 1309,32888374,Differential effects of adult attachment in cognitive-behavioural and psychodynamic therapy in social anxiety disorder: A comparison between a self-rating and an observer rating.,"Different measures of attachment are usually weakly correlated. In a subsample of an RCT comparing short-term cognitive-behavioural therapy (CBT) and psychodynamic therapy (PDT), we examined the association between attachment and outcome using two attachment measures. The sample comprises 148 patients with social anxiety disorder who were treated in the SOPHO-NET trial. Pretreatment attachment was assessed using the Adult Attachment Prototype Rating (AAPR) and the Bielefeld Questionnaire of Client Expectations (BQCE). Regression models were used to predict the therapeutic alliance (HAQ) at session 8, the Liebowitz Social Anxiety Scale (LSAS) at the end of therapy and a 6-month follow-up. Attachment groups (secure, avoidant, and ambivalent) classified with the AAPR and the BQCE were not significantly correlated (Cohen's κ = 0.08). Only the BQCE was associated with the HAQ indicating avoidantly attached patients showing lower HAQ scores than securely attached (Cohen's d = 0.722). Regarding the AAPR, we found an interaction effect of treatment and attachment related to the post-treatment LSAS scores. Post hoc tests revealed that securely attached patients in CBT had lower scores than securely attached in PDT (d = 0.922) and, on a trend level, avoidantly attached in CBT (d = 0.782). We conclude that attachment-outcome associations are affected by the applied measure. The identified differential effects suggest that psychotherapists should adapt the interventions on the attachment of their patients.",2021,Only the BQCE was associated with the HAQ indicating avoidantly attached patients showing lower HAQ scores than securely attached (Cohen's d=0.722).,"['148 patients with social anxiety disorder who were treated in the SOPHO-NET trial', 'social anxiety disorder']","['RCT comparing short-term cognitive-behavioral therapy (CBT) and psychodynamic therapy (PDT', 'cognitive-behavioral and psychodynamic therapy']","['Liebowitz Social Anxiety Scale (LSAS', 'HAQ scores', 'Adult Attachment Prototype Rating (AAPR) and the Bielefeld Questionnaire of Client Expectations (BQCE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0102923', 'cui_str': 'ametantrone'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}]",148.0,0.0100143,Only the BQCE was associated with the HAQ indicating avoidantly attached patients showing lower HAQ scores than securely attached (Cohen's d=0.722).,"[{'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Altmann', 'Affiliation': 'Institute of Psychosocial Medicine, Psychotherapy and Psycho-Oncology, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Steffi', 'Initials': 'S', 'LastName': 'Nodop', 'Affiliation': 'Institute of Psychosocial Medicine, Psychotherapy and Psycho-Oncology, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Dinger', 'Affiliation': 'Department of General Internal Medicine and Psychosomatics, University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'Ehrenthal', 'Affiliation': 'Institute of Medical Psychology, University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Schauenburg', 'Affiliation': 'Department of General Internal Medicine and Psychosomatics, University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Wibke', 'Initials': 'W', 'LastName': 'Dymel', 'Affiliation': 'Private Practice, Essen, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Willutzki', 'Affiliation': 'Department of Psychology and Psychotherapy, University of Witten-Herdecke, Witten-Herdecke, Germany.'}, {'ForeName': 'Bernhard M', 'Initials': 'BM', 'LastName': 'Strauss', 'Affiliation': 'Institute of Psychosocial Medicine, Psychotherapy and Psycho-Oncology, Jena University Hospital, Jena, Germany.'}]",Clinical psychology & psychotherapy,['10.1002/cpp.2513'] 1310,32876831,Patient preferences for development in MRI scanner design: a survey of claustrophobic patients in a randomized study.,"OBJECTIVE To investigate which magnetic resonance imaging (MRI) scanner designs claustrophobic patients prefer. MATERIAL/METHODS We analyzed questionnaires completed by 160 patients at high risk for claustrophobia directly after a scan in either a short-bore or open panoramic scanner as part of a prospective randomized trial Enders et al (BMC Med Imaging 11:4, 2011). Scanner preferences were judged based on schematic drawings of four scanners. Information on the diagnostic performance of the depicted scanners was provided, too. RESULTS A majority of patients suggested upright open (59/160, 36.9%) and open panoramic (53/160, 33.1%) before short-bore designs (26/160, 16.3%, for all p < 0.001) for future development. When asked about patients' preferred scanner choice for an upcoming examination, information about a better diagnostic performance of a short-bore scanner significantly improved its preference rates (from 6/160 to 49/160 or 3.8 to 30.5%, p < 0.001). Patients with a claustrophobic event preferred open designs significantly more often than patients without a claustrophobic event (p = 0.047). Patients scanned in a short-bore scanner in our trial preferred this design significantly more often (p = 0.003). Noise reduction (51/160, 31.9%), more space over the head (44/160, 27.5%), and overall more space (33/160, 20.6%) were the commonest suggested areas of improvement. CONCLUSION Patients at high risk for claustrophobia visually prefer open- over short-bore MRI designs for further development. Education about a better diagnostic performance of a visually less-attractive scanner can increase its acceptance. Noise and space were of most concern for claustrophobic patients. This information can guide individual referral of claustrophobic patients to scanners and future scanner development. KEY POINTS • Patients at high risk for claustrophobia visually favor the further development of open scanners as opposed to short- and closed-bore scanner designs. • Educating claustrophobic patients about a higher diagnostic performance of a short-bore scanner can significantly increase their acceptance of this otherwise visually less-attractive design. • A medical history of earlier claustrophobic events in a given MRI scanner type and focusing on the features ""more space"" and ""noise reduction"" can help to guide referral of patients who are at high risk for claustrophobia.",2021,Patients with a claustrophobic event preferred open designs significantly more often than patients without a claustrophobic event (p = 0.047).,"['160 patients at high risk for claustrophobia directly after a scan in either a', 'patients who are at high risk for claustrophobia']","['short-bore or open panoramic scanner', 'magnetic resonance imaging (MRI) scanner']","['diagnostic performance', 'preference rates', 'open panoramic', 'Noise reduction']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0008909', 'cui_str': 'Claustrophobia'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C2945608', 'cui_str': 'Bore'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.0373504,Patients with a claustrophobic event preferred open designs significantly more often than patients without a claustrophobic event (p = 0.047).,"[{'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Iwan', 'Affiliation': 'Departement of Anaesthesiology, Charité Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Jinhua', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Radiology, Charité Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Enders', 'Affiliation': 'Department of Radiology, Charité Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Adriane Elisabeth', 'Initials': 'AE', 'LastName': 'Napp', 'Affiliation': 'Department of Radiology, Campus Virchow-Klinikum Klinik für Pädiatrie m.S. Onkologie und Hämatologie, Charité Berlin, Mittelallee 8, 4. OG Augustenburger Platz 1, 13353, Berlin, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Rief', 'Affiliation': 'Department of Radiology, Charité Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Dewey', 'Affiliation': 'Department of Radiology, Charité Berlin, Charitéplatz 1, 10117, Berlin, Germany. marc.dewey@charite.de.'}]",European radiology,['10.1007/s00330-020-07060-9'] 1311,32875456,Effect of exercise training on cardiovascular autonomic and muscular function in subclinical Chagas cardiomyopathy: a randomized controlled trial.,"PURPOSE Patients with chronic chagasic cardiomyopathy with preserved ventricular function present with autonomic imbalance. This study evaluated the effects of exercise training (ET) in restoring peripheral and cardiac autonomic control and skeletal muscle phenotype in patients with subclinical chronic chagasic cardiomyopathy. METHODS This controlled trial (NCT02295215) included 24 chronic chagasic cardiomyopathy patients who were randomized www.random.org/lists/ into two groups: those who underwent exercise training (n = 12) and those who continued their usual activities (n = 12). Eight patients completed the exercise training protocol, and 10 patients were clinically followed up for 4 months. Muscular sympathetic nerve activity was measured by microneurography and muscle blood flow (MBF) using venous occlusion plethysmography. The low-frequency component of heart rate variability in normalized units (LFnuHR) reflects sympathetic activity in the heart, and the low-frequency component of systolic blood pressure variability in normalized units reflects sympathetic activity in the vessels. The infusion of vasoactive drugs (phenylephrine and sodium nitroprusside) was used to evaluate cardiac baroreflex sensitivity, and a vastus lateralis muscle biopsy was performed to evaluate atrogin-1 and MuRF-1 gene expression. RESULTS The baroreflex sensitivity for increases (p = 0.002) and decreases (p = 0.02) in systolic blood pressure increased in the ET group. Muscle blood flow also increased only in the ET group (p = 0.004). Only the ET group had reduced resting muscular sympathetic nerve activity levels (p = 0.008) and sympathetic activity in the heart (LFnu; p = 0.004) and vessels (p = 0.04) after 4 months. Regarding skeletal muscle, after 4 months, participants in the exercise training group presented with lower atrogin-1 gene expression than participants who continued their activities as usual (p = 0.001). The reduction in muscular sympathetic nerve activity was positively associated with reduced atrogin-1 (r = 0.86; p = 0.02) and MuRF-1 gene expression (r = 0.64; p = 0.06); it was negatively associated with improved baroreflex sensitivity both for increases (r = -0.72; p = 0.020) and decreases (r = -0.82; p = 0.001) in blood pressure. CONCLUSIONS ET improved cardiac and peripheral autonomic function in patients with subclinical chagasic cardiomyopathy. ET reduced MSNA and sympathetic activity in the heart and vessels and increased cardiac parasympathetic tone and baroreflex sensitivity. Regarding peripheral muscle, after 4 months, patients who underwent exercise training had an increased cross-sectional area of type I fibers and oxidative metabolism of muscle fibers, and decreased atrogin-1 gene expression, compared to participants who continued their activities as usual. In addition, the reduction in MSNA was associated with improved cardiac baroreflex sensitivity, reduced sympathetic cardiovascular tone, and reduced atrogin-1 and MuRF-1 gene expression. TRIAL REGISTRATION ID: NCT02295215. Registered in June 2013.",2021,Only the ET group had reduced resting muscular sympathetic nerve activity levels (p = 0.008) and sympathetic activity in the heart (LFnu; p = 0.004) and vessels (p = 0.04) after 4 months.,"['Patients with chronic chagasic cardiomyopathy with preserved ventricular function present with autonomic imbalance', 'patients with subclinical chronic chagasic cardiomyopathy', '24 chronic chagasic cardiomyopathy patients who were randomized', 'subclinical Chagas cardiomyopathy', 'patients with subclinical chagasic cardiomyopathy']","['exercise training', 'exercise training (ET', 'exercise training protocol', 'www.random.org/lists', 'vasoactive drugs (phenylephrine and sodium nitroprusside', 'exercise training (n\u2009=\u200912) and those who continued their usual activities']","['sympathetic activity', 'Muscle blood flow', 'blood pressure', 'Muscular sympathetic nerve activity', 'muscular sympathetic nerve activity', 'cardiac parasympathetic tone and baroreflex sensitivity', 'cross-sectional area of type I fibers and oxidative metabolism of muscle fibers, and decreased atrogin-1 gene expression', 'resting muscular sympathetic nerve activity levels', 'MuRF-1 gene expression', 'systolic blood pressure', 'cardiac and peripheral autonomic function', 'cardiovascular autonomic and muscular function', 'MSNA and sympathetic activity', 'baroreflex sensitivity', 'cardiac baroreflex sensitivity, reduced sympathetic cardiovascular tone, and reduced atrogin-1 and MuRF-1 gene expression', 'cardiac baroreflex sensitivity', 'microneurography and muscle blood flow (MBF', 'lower atrogin-1 gene expression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0080309', 'cui_str': 'Ventricular Function'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0262385', 'cui_str': 'Autonomic nervous system imbalance'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0007930', 'cui_str': ""Chagas' disease with heart involvement""}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0037533', 'cui_str': 'Sodium nitroprusside'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0206162', 'cui_str': 'Baroreceptor reflex'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0282636', 'cui_str': 'Respiration, Cell'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0968461', 'cui_str': 'TRIM63 protein, human'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",24.0,0.0241637,Only the ET group had reduced resting muscular sympathetic nerve activity levels (p = 0.008) and sympathetic activity in the heart (LFnu; p = 0.004) and vessels (p = 0.04) after 4 months.,"[{'ForeName': 'Adriana Oliveira', 'Initials': 'AO', 'LastName': 'Sarmento', 'Affiliation': 'Heart Institute (InCor), Unidade de Reabilitação Cardiovascular E Fisiologia Do Exercício, University of Sao Paulo Medical School, Av. Dr. Enéas de Carvalho Aguiar, 44, Cerqueira César, São Paulo, SP, CEP 05403-000, Brazil. adriana.sarmento@usp.br.'}, {'ForeName': 'Ligia M', 'Initials': 'LM', 'LastName': 'Antunes-Correa', 'Affiliation': 'Heart Institute (InCor), Unidade de Reabilitação Cardiovascular E Fisiologia Do Exercício, University of Sao Paulo Medical School, Av. Dr. Enéas de Carvalho Aguiar, 44, Cerqueira César, São Paulo, SP, CEP 05403-000, Brazil.'}, {'ForeName': 'Maria J N N', 'Initials': 'MJNN', 'LastName': 'Alves', 'Affiliation': 'Heart Institute (InCor), Unidade de Reabilitação Cardiovascular E Fisiologia Do Exercício, University of Sao Paulo Medical School, Av. Dr. Enéas de Carvalho Aguiar, 44, Cerqueira César, São Paulo, SP, CEP 05403-000, Brazil.'}, {'ForeName': 'Aline V N', 'Initials': 'AVN', 'LastName': 'Bacurau', 'Affiliation': 'School of Physical Education and Sports, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Keila C B', 'Initials': 'KCB', 'LastName': 'Fonseca', 'Affiliation': 'Heart Institute (InCor), Unidade de Reabilitação Cardiovascular E Fisiologia Do Exercício, University of Sao Paulo Medical School, Av. Dr. Enéas de Carvalho Aguiar, 44, Cerqueira César, São Paulo, SP, CEP 05403-000, Brazil.'}, {'ForeName': 'Fernanda G', 'Initials': 'FG', 'LastName': 'Pessoa', 'Affiliation': 'Heart Institute (InCor), Unidade de Reabilitação Cardiovascular E Fisiologia Do Exercício, University of Sao Paulo Medical School, Av. Dr. Enéas de Carvalho Aguiar, 44, Cerqueira César, São Paulo, SP, CEP 05403-000, Brazil.'}, {'ForeName': 'Denise M L', 'Initials': 'DML', 'LastName': 'Lobo', 'Affiliation': 'Heart Institute (InCor), Unidade de Reabilitação Cardiovascular E Fisiologia Do Exercício, University of Sao Paulo Medical School, Av. Dr. Enéas de Carvalho Aguiar, 44, Cerqueira César, São Paulo, SP, CEP 05403-000, Brazil.'}, {'ForeName': 'Leila D P', 'Initials': 'LDP', 'LastName': 'Moreira', 'Affiliation': 'Heart Institute (InCor), Unidade de Reabilitação Cardiovascular E Fisiologia Do Exercício, University of Sao Paulo Medical School, Av. Dr. Enéas de Carvalho Aguiar, 44, Cerqueira César, São Paulo, SP, CEP 05403-000, Brazil.'}, {'ForeName': 'Ivani C', 'Initials': 'IC', 'LastName': 'Trombetta', 'Affiliation': 'Universidade Nove de Julho, Sao Paulo, Brazil.'}, {'ForeName': 'Maria U P B', 'Initials': 'MUPB', 'LastName': 'Rondon', 'Affiliation': 'School of Physical Education and Sports, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Rondon', 'Affiliation': 'School of Physical Education and Sports, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Marcelo L C', 'Initials': 'MLC', 'LastName': 'Vieira', 'Affiliation': 'Heart Institute (InCor), Unidade de Reabilitação Cardiovascular E Fisiologia Do Exercício, University of Sao Paulo Medical School, Av. Dr. Enéas de Carvalho Aguiar, 44, Cerqueira César, São Paulo, SP, CEP 05403-000, Brazil.'}, {'ForeName': 'Felix J A', 'Initials': 'FJA', 'LastName': 'Ramires', 'Affiliation': 'Heart Institute (InCor), Unidade de Reabilitação Cardiovascular E Fisiologia Do Exercício, University of Sao Paulo Medical School, Av. Dr. Enéas de Carvalho Aguiar, 44, Cerqueira César, São Paulo, SP, CEP 05403-000, Brazil.'}, {'ForeName': 'Maria Socorro', 'Initials': 'MS', 'LastName': 'do Brasileiro-Santos', 'Affiliation': 'Associate Post-Graduate Program in Physical Education University of Pernambuco, Federal University of Paraiba, Joao Pessoa, Brazil.'}, {'ForeName': 'Patricia C', 'Initials': 'PC', 'LastName': 'Brum', 'Affiliation': 'School of Physical Education and Sports, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Mady', 'Affiliation': 'Heart Institute (InCor), Unidade de Reabilitação Cardiovascular E Fisiologia Do Exercício, University of Sao Paulo Medical School, Av. Dr. Enéas de Carvalho Aguiar, 44, Cerqueira César, São Paulo, SP, CEP 05403-000, Brazil.'}, {'ForeName': 'Carlos E', 'Initials': 'CE', 'LastName': 'Negrao', 'Affiliation': 'Heart Institute (InCor), Unidade de Reabilitação Cardiovascular E Fisiologia Do Exercício, University of Sao Paulo Medical School, Av. Dr. Enéas de Carvalho Aguiar, 44, Cerqueira César, São Paulo, SP, CEP 05403-000, Brazil.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': 'Faculty of Kinesiology and Physical Education of University of Toronto, Toronto, Canada.'}, {'ForeName': 'Barbara M', 'Initials': 'BM', 'LastName': 'Ianni', 'Affiliation': 'Heart Institute (InCor), Unidade de Reabilitação Cardiovascular E Fisiologia Do Exercício, University of Sao Paulo Medical School, Av. Dr. Enéas de Carvalho Aguiar, 44, Cerqueira César, São Paulo, SP, CEP 05403-000, Brazil.'}]",Clinical autonomic research : official journal of the Clinical Autonomic Research Society,['10.1007/s10286-020-00721-1'] 1312,32886795,Locomotor muscle group III/IV afferents constrain stroke volume and contribute to exercise intolerance in human heart failure.,"KEY POINTS Heart failure patients with reduced ejection fraction (HFrEF) exhibit severe limitations in exercise capacity ( V ̇ O 2 peak). One of the primary peripheral mechanisms suggested to underlie exercise intolerance in HFrEF is excessive locomotor muscle group III/IV afferent feedback; however, this has never been investigated in human heart failure. HFrEF patients and controls performed an incremental exercise test to volitional exhaustion to determine V ̇ O 2 peak with lumbar intrathecal fentanyl or placebo. During exercise, cardiac output, leg blood flow and radial artery and femoral venous blood gases were measured. With fentanyl, compared with placebo, patients with HFrEF achieved a higher peak workload, V ̇ O 2 peak, cardiac output, stroke volume and leg blood flow. These findings suggest that locomotor muscle group III/IV afferent feedback in HFrEF leads to increased systemic vascular resistance, which constrains stroke volume, cardiac output and O 2 delivery thereby impairing V ̇ O 2 peak and thus exercise capacity. ABSTRACT To better understand the underlying mechanisms contributing to exercise limitation in heart failure with reduced ejection fraction (HFrEF), we investigated the influence of locomotor muscle group III/IV afferent inhibition via lumbar intrathecal fentanyl on peak exercise capacity ( V ̇ O 2 peak) and the contributory mechanisms. Eleven HFrEF patients and eight healthy matched controls were recruited. The participants performed an incremental exercise test to volitional exhaustion to determine V ̇ O 2 peak with lumbar intrathecal fentanyl or placebo. During exercise, cardiac output and leg blood flow ( Q ̇ L ) were measured via open-circuit acetylene wash-in technique and constant infusion thermodilution, respectively. Radial artery and femoral venous blood gases were measured. V ̇ O 2 peak was 15% greater with fentanyl compared with placebo for HFrEF (P < 0.01), while no different in the controls. During peak exercise with fentanyl, cardiac output was 12% greater in HFrEF secondary to significant decreases in systemic vascular resistance and increases in stroke volume compared with placebo (all, P < 0.01). From placebo to fentanyl, leg V ̇ O 2 , Q ̇ L and O 2 delivery were greater for HFrEF during peak exercise (all, P < 0.01), but not control. These findings indicate that locomotor muscle group III/IV afferent feedback in patients with HFrEF leads to increased systemic vascular resistance, which constrains stroke volume, cardiac output and O 2 delivery, thereby impairing V ̇ O 2 peak and thus exercise capacity. These findings have important clinical implications as V ̇ O 2 peak is highly predictive of morbidity and mortality in HF.",2020,"Results V̇O 2 peak was 15% greater with fentanyl compared to placebo for HFrEF (p<0.01), while not different in the controls.","['Eleven HFrEF patients and 8 healthy matched controls were recruited', 'Heart failure patients with reduced ejection fraction (HFrEF) exhibit severe limitations in exercise capacity (V̇O 2 peak', 'human heart failure', 'heart failure with reduced ejection fraction (HFrEF']","['fentanyl', 'HFrEF', 'incremental exercise test to volitional exhaustion to determine V̇O 2 peak with lumbar intrathecal fentanyl or placebo', 'placebo', 'Locomotor muscle group III/IV afferents constrain stroke volume']","['systemic vascular resistance', 'peak exercise capacity', 'cardiac output and leg blood flow (Q̇', 'Radial artery and femoral venous blood gases', 'cardiac output, leg blood flow, and radial artery and femoral venous blood gases', 'leg V̇O 2 , Q̇ L , and O 2 delivery', 'systemic vascular resistance, which constrains stroke volume, cardiac output, and O 2 delivery thereby impairing V̇O 2 peak and thus exercise capacity', 'stroke volume', 'peak workload, V̇O 2 peak, cardiac output, stroke volume, and leg blood flow']","[{'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205115', 'cui_str': 'Afferent'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}]","[{'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}]",11.0,0.0913429,"Results V̇O 2 peak was 15% greater with fentanyl compared to placebo for HFrEF (p<0.01), while not different in the controls.","[{'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Smith', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, MN, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Joyner', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, MN, USA.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Curry', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, MN, USA.'}, {'ForeName': 'Barry A', 'Initials': 'BA', 'LastName': 'Borlaug', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, MN, USA.'}, {'ForeName': 'Manda L', 'Initials': 'ML', 'LastName': 'Keller-Ross', 'Affiliation': 'Division of Physical Therapy and Rehabilitation Sciences, University of Minnesota, MN, USA.'}, {'ForeName': 'Erik H', 'Initials': 'EH', 'LastName': 'Van Iterson', 'Affiliation': 'Section of Preventative Cardiology and Rehabilitation, Cleveland Clinic, MN, USA.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Olson', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, MN, USA.'}]",The Journal of physiology,['10.1113/JP280333'] 1313,32896932,"Comparative Effectiveness of 755-nm Picosecond Laser, 755- and 532-nm Nanosecond Lasers for Treatment of Café-au-Lait Macules (CALMs): A Randomized, Split-Lesion Clinical Trial.","BACKGROUND AND OBJECTIVES Many types of lasers have been used to treat café-au-lait macules (CALMs) since the introduction of the selective photothermolysis theory. However, the efficacy and safety of picosecond lasers, compared with those of nanosecond lasers, have not been researched. To compare the efficacy and safety of 755 nm picosecond laser (PS-755 nm), Q-switched (QS) Alexandrite 755 nm nanosecond laser (QS-755 nm), and QS Nd:YAG 532 nm nanosecond laser (QS-532 nm) for treating CALMs. STUDY DESIGN/MATERIALS AND METHODS Forty-one patients received several treatments at 3-month intervals. Lesions were divided into two or three approximately equal parts, which were randomly treated with PS-755 nm, QS-755 nm, and QS-532 nm. The safety and efficacy of three lasers were determined based on blinded visual assessments and self-reports of patients three months after the comparative trial. RESULTS Visual assessment 3 months after the comparative trial revealed that there was no statistically significant difference among the sites treated by QS-755 nm (2.84 ± 1.11), QS-532 nm (2.63 ± 1.06), and PS-755 nm (2.74 ± 1.05) lasers. Five (26.32%) of 19 patients showed lesion recurrence. Adverse effects included acneiform miliaris, hypopigmentation, and hyperpigmentation, which were resolved within 12 months. Five (26.32%) of 19 patients who showed lesion recurrence 1-5 months after laser treatment had lightened or cleared at least 50% of the lesion. 46.67% of patients were satisfied or very satisfied with the outcome of the overall treatment. CONCLUSIONS PS-755 nm, QS-755 nm, and QS-532 nm laser treatments were equally effective in treating and improving CALMs. PS-755 nm caused fewer adverse effects. Individuals can react differently to different types of lasers. Patch tests should be conducted before the treatment. Lasers Surg. Med. © 2020 Wiley Periodicals LLC.",2021,"RESULTS Visual assessment 3 months after the comparative trial revealed that there was no statistically significant difference among the sites treated by QS-755 nm (2.84 ± 1.11), QS-532 nm (2.63 ± 1.06), and PS-755 nm (2.74 ± 1.05) lasers.","['Café-au-Lait Macules (CALMs', 'Forty-one patients received several treatments at 3-month intervals']","['nm nanosecond laser (QS-755\u2009nm), and QS Nd:YAG 532\u2009nm nanosecond laser (QS-532\u2009nm', 'PS-755\u2009nm, QS-755\u2009nm, and QS-532\u2009nm', '755\u2009nm picosecond laser (PS-755\u2009nm), Q-switched (QS) Alexandrite 755', 'picosecond lasers', '755-nm Picosecond Laser, 755- and 532-nm Nanosecond Lasers']","['acneiform miliaris, hypopigmentation, and hyperpigmentation', 'efficacy and safety', 'lesion recurrence', 'safety and efficacy', 'adverse effects']","[{'cui': 'C0332573', 'cui_str': 'Macule'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C0439225', 'cui_str': 'ns'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C4517872', 'cui_str': '755'}, {'cui': 'C1532556', 'cui_str': 'Picosecond pulsed laser device'}, {'cui': 'C0675767', 'cui_str': 'alexandrite'}]","[{'cui': 'C0162835', 'cui_str': 'Hypopigmentation'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.036735,"RESULTS Visual assessment 3 months after the comparative trial revealed that there was no statistically significant difference among the sites treated by QS-755 nm (2.84 ± 1.11), QS-532 nm (2.63 ± 1.06), and PS-755 nm (2.74 ± 1.05) lasers.","[{'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Cen', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, No. 639 Zhizaoju Road, Shanghai, Shanghai, 200011, PR China.""}, {'ForeName': 'Yifei', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, No. 639 Zhizaoju Road, Shanghai, Shanghai, 200011, PR China.""}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Luo', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, No. 639 Zhizaoju Road, Shanghai, Shanghai, 200011, PR China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Shang', 'Affiliation': ""Department of Laser and Aesthetic Medicine, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, No. 639 Zhizaoju Road, Shanghai, Shanghai, 200011, PR China.""}, {'ForeName': 'Yamin', 'Initials': 'Y', 'LastName': 'Rao', 'Affiliation': ""Department of Pathology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, No. 639 Zhizaoju Road, Shanghai, Shanghai, 200011, PR China.""}, {'ForeName': 'Jiafang', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': ""Department of Laser and Aesthetic Medicine, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, No. 639 Zhizaoju Road, Shanghai, Shanghai, 200011, PR China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, No. 639 Zhizaoju Road, Shanghai, Shanghai, 200011, PR China.""}, {'ForeName': 'Wenxin', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': ""Department of Laser and Aesthetic Medicine, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, No. 639 Zhizaoju Road, Shanghai, Shanghai, 200011, PR China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Laser and Aesthetic Medicine, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, No. 639 Zhizaoju Road, Shanghai, Shanghai, 200011, PR China.""}, {'ForeName': 'Xianglei', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""Department of Laser and Aesthetic Medicine, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, No. 639 Zhizaoju Road, Shanghai, Shanghai, 200011, PR China.""}, {'ForeName': 'Hanru', 'Initials': 'H', 'LastName': 'Ying', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, No. 639 Zhizaoju Road, Shanghai, Shanghai, 200011, PR China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Ma', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, No. 639 Zhizaoju Road, Shanghai, Shanghai, 200011, PR China.""}, {'ForeName': 'Xiaoxi', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, No. 639 Zhizaoju Road, Shanghai, Shanghai, 200011, PR China.""}]",Lasers in surgery and medicine,['10.1002/lsm.23316'] 1314,32888340,"Randomized Double-blind Trial of Intramuscular Droperidol, Ziprasidone, and Lorazepam for Acute Undifferentiated Agitation in the Emergency Department.","BACKGROUND The optimal agent to treat acute agitation in the emergency department (ED) has not been determined. The objective of this study was to compare the effectiveness and safety of intramuscular droperidol, ziprasidone, and lorazepam for acute agitation in the ED. METHODS This was a randomized, double-blind trial of ED patients with acute agitation requiring parenteral sedation. The study was conducted under exception from informed consent (21 CFR 50.24) from July 2004 to March 2005. Patients were randomized to receive 5 mg of droperidol, 10 mg of ziprasidone, 20 mg of ziprasidone, or 2 mg of lorazepam intramuscularly. We recorded Altered Mental Status Scale (AMSS) scores, nasal end-tidal carbon dioxide (ETCO 2 ), and pulse oximetry (SpO 2 ) at 0, 15, 30, 45, 60, 90, and 120 minutes as well as QTc durations and dysrhythmias. Respiratory depression was defined as a change in ETCO 2 consistent with respiratory depression or SpO 2  < 90%. The primary outcome was the proportion of patients adequately sedated (AMSS ≤ 0) at 15 minutes. RESULTS We enrolled 115 patients. Baseline AMSS scores were similar between groups. For the primary outcome, adequate sedation at 15 minutes, droperidol administration was effective in 16 of 25 (64%) patients, compared to seven of 28 (25%) for 10 mg of ziprasidone, 11 of 31 (35%) for 20 mg of ziprasidone, and nine of 31 (29%) for lorazepam. Pairwise comparisons revealed that droperidol was more effective that the other medications, with 39% (95% confidence interval [CI] = 3% to 54%) more compared to 20 mg of ziprasidone and 33% (95% CI = 8% to 58%) more compared to lorazepam. There was no significant difference between groups in need of additional rescue sedation. Numerically, respiratory depression was lower with droperidol (3/25 [12%]) compared to 10 mg of ziprasidone (10/28 [36%]), 20 mg of ziprasidone (12/31 [39%]), or lorazepam (15/31 [48%]). One patient receiving 20 mg of ziprasidone required intubation to manage an acute subdural hematoma. No patients had ventricular dysrhythmias. QTc durations were similar in all groups. CONCLUSIONS Droperidol was more effective than lorazepam or either dose of ziprasidone for the treatment of acute agitation in the ED and caused fewer episodes of respiratory depression.",2021,"CONCLUSIONS Droperidol was more effective than lorazepam or either dose of ziprasidone for the treatment of acute agitation in the emergency department and caused fewer episodes of respiratory depression.","['ED patients with acute agitation requiring parenteral sedation', 'Acute Undifferentiated Agitation in the Emergency Department', 'We enrolled 115 patients']","['Droperidol', 'ziprasidone 20mg required intubation', 'droperidol', 'Intramuscular Droperidol, Ziprasidone and Lorazepam', 'droperidol 5mg, ziprasidone 10mg, ziprasidone 20mg, or lorazepam', 'lorazepam', 'ziprasidone', 'droperidol, ziprasidone, and lorazepam']","['proportion of patients adequately sedated (AMSS≤0', 'adequate sedation', 'episodes of respiratory depression', 'Respiratory depression', 'effectiveness and safety', 'QTc durations and dysrhythmias', 'Altered Mental Status Scale (AMSS) scores, nasal end-tidal carbon dioxide (ETCO2), and pulse oximetry (SpO2', 'ventricular dysrhythmias', 'respiratory depression', 'need of additional rescue sedation', 'Baseline AMSS scores', 'QTc durations']","[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0205618', 'cui_str': 'Undifferentiated'}, {'cui': 'C4517540', 'cui_str': '115'}]","[{'cui': 'C0013136', 'cui_str': 'Droperidol'}, {'cui': 'C1126071', 'cui_str': 'ziprasidone 20 MG'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0380393', 'cui_str': 'ziprasidone'}, {'cui': 'C0024002', 'cui_str': 'Lorazepam'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0278061', 'cui_str': 'Altered mental status'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0034108', 'cui_str': 'Pulse oximetry'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",115.0,0.42974,"CONCLUSIONS Droperidol was more effective than lorazepam or either dose of ziprasidone for the treatment of acute agitation in the emergency department and caused fewer episodes of respiratory depression.","[{'ForeName': 'Marc L', 'Initials': 'ML', 'LastName': 'Martel', 'Affiliation': 'From the, Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, MN, USA.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Driver', 'Affiliation': 'From the, Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, MN, USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Miner', 'Affiliation': 'From the, Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, MN, USA.'}, {'ForeName': 'Michelle H', 'Initials': 'MH', 'LastName': 'Biros', 'Affiliation': 'and the, Department of Emergency Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Jon B', 'Initials': 'JB', 'LastName': 'Cole', 'Affiliation': 'From the, Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, MN, USA.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14124'] 1315,32888343,The impact of survey mode on US national estimates of adolescent drug prevalence: results from a randomized controlled study.,"BACKGROUND AND AIMS Increasing numbers of school-based drug surveys are transitioning data collection to electronic tablets from paper-and-pencil, which may produce a survey mode effect and consequent discontinuity in time trends for population estimates of drug prevalence. This study tested whether (a) overall, self-reported drug use prevalence is higher on electronic tablets versus paper-and-pencil surveys, (b) socio-demographics moderate survey mode effects and (c) levels of missing data are lower for electronic tablet versus paper-and-pencil modes. DESIGN A randomized controlled experiment. SETTING Results are nationally representative of students in the contiguous United States. PARTICIPANTS A total of 41 866 8th, 10th and 12th grade students who participated in the 2019 Monitoring the Future school-based survey administration. INTERVENTION AND COMPARATOR Surveys were administered to students in a randomly selected half of schools with electronic tablets (intervention) and with paper-and-pencil format (comparator) for the other half. MEASUREMENTS Primary outcome was the total number of positive drug use responses. Secondary outcomes were the percentage of respondents completing all drug questions, percentage of drug questions unanswered and mean number of missing drug items. FINDINGS The relative risk (RR) for total number of positive drug use responses for electronic tablets versus paper-and-pencil surveys were small and their 95% confidence intervals (CI) included the value of one for reporting intervals of life-time (RR = 1.03; 95% CI, 0.93-1.14), past 12 months (RR = 1.01; 95% CI, 0.91-1.11), past 30 days (RR = 1.05; 95% CI, 0.93-1.20) and for heavy use (RR = 1.10; 95% CI, 0.93-1.29). Multiplicative interaction tests indicated no moderation of these relative risks by race (white versus non-white), population density, census region, public/private school, year of school participation, survey version or non-complete drug responses. Levels of missing data were significantly lower for electronic tablets versus paper-and-pencil surveys. CONCLUSIONS Adolescent drug prevalence estimates in the United States differed little across electronic tablet versus paper-and-pencil survey modes, and showed little to no effect modification by socio-demographics. Levels of missing data were lower for electronic tablets.",2021,"Multiplicative interaction tests indicated no moderation of these relative risks by race (white v. nonwhite), population density, census region, public/private school, year of school participation, survey version, or non-complete drug responses.","['41,866 8th, 10th, and 12th grade students who participated in the 2019 Monitoring the Future school-based survey administration', 'Results are nationally-representative of students in the contiguous United States', 'Adolescent Drug Prevalence']",['electronic tablets (intervention) and with paper-and-pencil format (comparator) for the other half'],"['total number of positive drug use responses', 'percent of respondents completing all drug questions, percent of drug questions unanswered, and mean number of missing drug items', 'Levels of missing data']","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205283', 'cui_str': 'Contiguous'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0441059', 'cui_str': 'Pencil'}, {'cui': 'C1301627', 'cui_str': 'Format'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",41866.0,0.149561,"Multiplicative interaction tests indicated no moderation of these relative risks by race (white v. nonwhite), population density, census region, public/private school, year of school participation, survey version, or non-complete drug responses.","[{'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Miech', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Mick P', 'Initials': 'MP', 'LastName': 'Couper', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Heeringa', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Patrick', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15249'] 1316,32896158,The Effect of Anonymous Computer-Mediated Communication on State Anxiety: An Experimental Study.,"This study examined the effect of anonymous computer-mediated communication (CMC) on state anxiety, specifically focusing on whether the valence of the interaction affected state anxiety before completing an anxiety-inducing task. Sixty-two female participants aged 18-25 were randomly assigned to one of three conditions: positive CMC, negative CMC, and blog. Self-report measures of state anxiety were taken at baseline; after participants had been given instructions about the anxiety-inducing task; after 10 minutes of CMC/blog writing; and after the anxiety-inducing task had been completed. Results showed that participants in the positive CMC condition showed a significant and moderate decrease in anxiety following the CMC, whereas those in the negative CMC condition showed a nonsignificant but moderate increase in anxiety following the CMC. Anxiety remained relatively unaffected by the blog condition. After completing the anxiety-inducing task, there were no differences in anxiety scores between groups. The findings show that CMC can be beneficial for relieving state anxiety, but the valence of the communication is crucial. This has implications for advice and training given to those participating in and supporting CMC where mental health issues might be discussed.",2020,Anxiety remained relatively unaffected by the blog condition.,"['Sixty-two female participants aged 18-25', 'State Anxiety']","['anonymous computer-mediated communication (CMC', 'positive CMC, negative CMC, and blog', 'Anonymous Computer-Mediated Communication', 'CMC']","['state anxiety', 'anxiety scores', 'Anxiety', 'anxiety']","[{'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C2718045', 'cui_str': 'Blogs as Topic'}]","[{'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",62.0,0.0162615,Anxiety remained relatively unaffected by the blog condition.,"[{'ForeName': 'Joshua A B', 'Initials': 'JAB', 'LastName': 'Littler', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Reading, United Kingdom.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Haffey', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Reading, United Kingdom.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Wake', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Reading, United Kingdom.'}, {'ForeName': 'Helen F', 'Initials': 'HF', 'LastName': 'Dodd', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Reading, United Kingdom.'}]","Cyberpsychology, behavior and social networking",['10.1089/cyber.2020.0213'] 1317,32885571,Compensatory neuroadaptation to binge drinking: Human evidence for allostasis.,"Animal studies have established that acute alcohol increases neural inhibition and that frequent intoxication episodes elicit neuroadaptive changes in the excitatory/inhibitory neurotransmission balance. To compensate for the depressant effects of alcohol, neural hyperexcitability develops in alcohol use disorder and is manifested through withdrawal symptoms. It is unclear, however, whether neuroadaptive changes can be observed in young, emerging adults at lower levels of consumption in the absence of withdrawal symptoms. Here, we used an anatomically constrained magnetoencephalography method to assess cortical excitability in two independent sets of experiments. We measured early visual activity (1) in social drinkers during alcohol intoxication versus placebo conditions and (2) in parallel cohorts of sober binge drinkers (BDs) and light drinkers (LDs). Acute alcohol intoxication attenuated early sensory activity in the visual cortex in social drinkers, confirming its inhibitory effects on neurotransmission. In contrast, sober BDs showed greater neural responsivity compared with a matched group of LDs. A positive correlation between alcohol consumption and neural activity in BDs is indicative of cortical hyperexcitability associated with hazardous drinking. Furthermore, neural responsivity was positively correlated with alcohol intake in social drinkers whose drinking did not reach binge levels. This study provides novel evidence of compensatory imbalance reflected in the downregulation of inhibitory and upregulation of excitatory signaling associated with binge drinking in young, emerging adults. By contrasting acute effects and a history of BD, these results support the mechanistic model of allostasis. Direct neural measures are sensitive to synaptic currents and could serve as biomarkers of neuroadaptation.",2021,"Acute alcohol intoxication attenuated early sensory activity in the visual cortex in social drinkers, confirming its inhibitory effects on neurotransmission.","['young, emerging adults', 'social drinkers', 'parallel cohorts of sober binge drinkers (BDs) and light drinkers (LDs']",['alcohol intoxication versus placebo'],"['neural responsivity', 'early visual activity', 'cortical excitability']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337676', 'cui_str': 'Social drinker'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0556335', 'cui_str': 'Binge drinker'}, {'cui': 'C0556299', 'cui_str': 'Light drinker'}]","[{'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}]",,0.0242568,"Acute alcohol intoxication attenuated early sensory activity in the visual cortex in social drinkers, confirming its inhibitory effects on neurotransmission.","[{'ForeName': 'Angeles', 'Initials': 'A', 'LastName': 'Correas', 'Affiliation': 'Department of Psychology, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Cuesta', 'Affiliation': 'Department of Psychology, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'Burke Q', 'Initials': 'BQ', 'LastName': 'Rosen', 'Affiliation': 'Department of Psychology, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Maestu', 'Affiliation': 'Cognitive and Computational Neuroscience Laboratory, Centre of Biomedical Technology, Madrid, Spain.'}, {'ForeName': 'Ksenija', 'Initials': 'K', 'LastName': 'Marinkovic', 'Affiliation': 'Department of Psychology, San Diego State University, San Diego, California, USA.'}]",Addiction biology,['10.1111/adb.12960'] 1318,32901302,Is fasting still necessary prior to contrast-enhanced computed tomography? A randomized clinical study.,"OBJECTIVES There is very limited evidence to support the common practice of preparative fasting prior to contrast-enhanced computerized tomography (CT). This study examined the effect of withholding fasting orders, prior to contrast-enhanced CT, on the incidence of aspiration pneumonitis and adverse gastrointestinal symptoms. METHODS This randomized controlled trial enrolled hospitalized patients referred for non-emergency, contrast-enhanced CT scan to either at least 4 h of fasting or to an unrestricted consumption of liquids and solids up to the time of CT. The primary outcome was incidence of aspiration pneumonitis and the secondary outcomes were rates of adverse gastrointestinal symptoms (nausea and/or vomiting). RESULTS After excluding participants with incomplete follow-up, a total of 1080 participants were assigned to the fasting group and 1011 were assigned to the non-fasting group. Aspiration pneumonitis was not identified in either group. The mean time of fasting in the fasting group was 8.4 ± 1.6 h. Rates of nausea and vomiting were not statistically different between the fasting group compared with the non-fasting group, 6.6% vs. 7.6% (p = 0.37) and 2.6% vs. 3.0% (p = 0.58), respectively. A subgroup analysis of patients who were required to drink oral contrast agent (n = 1257) showed that rates of nausea and vomiting were not statistically different between the fasting and non-fasting groups, 6.8% vs. 8.0% (p = 0.42) and 2.6% vs. 3.6% (p = 0.3), respectively. CONCLUSIONS Withholding fasting orders prior to contrast-enhanced CT was not associated with a greater risk of aspiration pneumonitis or a significant increase in rates of adverse gastrointestinal symptoms. TRIAL REGISTRATION ClinicalTrials.gov : NCT03533348 KEY POINTS: • Is fasting necessary prior to contrast-enhanced computed tomography (CT)? • In this randomized clinical study including 2091 participants referred to non-emergency contrast-enhanced CT scan, withholding preparative fasting was not associated with a greater risk of aspiration pneumonitis or clinically significant increase in rates of adverse gastrointestinal symptoms. • Eating and drinking prior to contrast-enhanced CT can be allowed and are not associated with an increased risk of aspiration pneumonitis.",2021,"CONCLUSIONS Withholding fasting orders prior to contrast-enhanced CT was not associated with a greater risk of aspiration pneumonitis or a significant increase in rates of adverse gastrointestinal symptoms. ","['After excluding participants with incomplete follow-up, a total of 1080 participants were assigned to the fasting group and 1011 were assigned to the non-fasting group', 'enrolled hospitalized patients referred for non-emergency, contrast-enhanced CT scan to either at least 4\xa0h of fasting or to an unrestricted consumption of liquids and solids up to the time of CT', '2091 participants referred to non-emergency contrast-enhanced CT scan, withholding preparative fasting']",[],"['Aspiration pneumonitis', 'rates of nausea and vomiting', 'incidence of aspiration pneumonitis', 'mean time of fasting', 'nausea and vomiting', 'risk of aspiration pneumonitis', 'rates of adverse gastrointestinal symptoms', 'rates of adverse gastrointestinal symptoms (nausea and/or vomiting']","[{'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C5192768', 'cui_str': '1080'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0450317', 'cui_str': '1011'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",[],"[{'cui': 'C0032290', 'cui_str': 'Aspiration pneumonia'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",2091.0,0.0465246,"CONCLUSIONS Withholding fasting orders prior to contrast-enhanced CT was not associated with a greater risk of aspiration pneumonitis or a significant increase in rates of adverse gastrointestinal symptoms. ","[{'ForeName': 'Ziv', 'Initials': 'Z', 'LastName': 'Neeman', 'Affiliation': 'Department of Radiology, Emek Medical Center, Afula, Israel.'}, {'ForeName': 'Mayasa', 'Initials': 'M', 'LastName': 'Abu Ata', 'Affiliation': 'Department of Medicine D, Emek Medical Center, 18341, Afula, Israel.'}, {'ForeName': 'Elia', 'Initials': 'E', 'LastName': 'Touma', 'Affiliation': 'Department of Medicine D, Emek Medical Center, 18341, Afula, Israel.'}, {'ForeName': 'Walid', 'Initials': 'W', 'LastName': 'Saliba', 'Affiliation': 'Ruth and Bruce Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Ofra', 'Initials': 'O', 'LastName': 'Barnett-Griness', 'Affiliation': 'Ruth and Bruce Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Gralnek', 'Affiliation': 'Ruth and Bruce Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Wasim', 'Initials': 'W', 'LastName': 'Rock', 'Affiliation': 'Ruth and Bruce Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Naiel', 'Initials': 'N', 'LastName': 'Bisharat', 'Affiliation': 'Ruth and Bruce Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel. bisharat_na@clalit.org.il.'}]",European radiology,['10.1007/s00330-020-07255-0'] 1319,32901330,Safety Profile and Adverse Events of Special Interest for Fruquintinib in Chinese Patients with Previously Treated Metastatic Colorectal Cancer: Analysis of the Phase 3 FRESCO Trial.,"INTRODUCTION In FRESCO (Fruquintinib Efficacy and Safety in 3+ Line Colorectal Cancer Patients) trial, fruquintinib demonstrated a statistically significant and clinically meaningful overall survival benefit in Chinese patients with metastatic colorectal cancer (mCRC). However, its safety profile, including adverse events of special interest (AESIs) and treatment-emergent adverse events (TEAEs) by age, sex, and body mass index (BMI), is not well known. The present analysis evaluated the safety profile and AESIs for fruquintinib in the FRESCO trial. METHODS In FRESCO, eligible Chinese patients were randomized (2:1) to receive fruquintinib (5 mg once daily for 3 weeks, followed by 1 week off in 28-day cycles) or placebo plus best supportive care. Treatment-related AESIs and time to first occurrence of AESIs were summarized. Treatment-related TEAEs by age, sex, and BMI were also summarized. RESULTS A total of 266 patients (95.7%) in the fruquintinib group and 97 (70.8%) in the placebo group had at least one treatment-related TEAE; the mean relative dose intensity was 92% and 98%, respectively. In the fruquintinib group, the most common (in > 40% of patients) treatment-related AESIs were hypertension (55.4%), palmar-plantar erythrodysesthesia syndrome [known as hand-foot skin reaction (HFSR)] (49.3%), and proteinuria (42.1%). The most common treatment-related grade ≥ 3 AESIs (≥ 3% of patients) were hypertension (21.2%), HFSR (10.8%), and proteinuria (3.2%); the median time to onset of these events was 10, 21, and 20 days, respectively. Subgroup analysis by age, sex, and BMI revealed that the frequencies of treatment-related TEAEs were similar across all subgroups, and were consistent with the overall safety profile of fruquintinib. CONCLUSIONS The most common treatment-related grade ≥ 3 AEs were hypertension, HFSR, and proteinuria. The treatment-related TEAE profile of fruquintinib in Chinese patents with mCRC was comparable among different subgroups and consistent with that reported in the overall population. TRIAL REGISTRATION Clinical Trials identifier NCT02314819.",2020,"The treatment-related TEAE profile of fruquintinib in Chinese patents with mCRC was comparable among different subgroups and consistent with that reported in the overall population. ","['eligible Chinese patients', 'Chinese Patients with Previously Treated Metastatic Colorectal Cancer', 'Chinese patients with metastatic colorectal cancer (mCRC']","['placebo', 'placebo plus best supportive care']","['adverse events of special interest (AESIs) and treatment-emergent adverse events (TEAEs) by age, sex, and body mass index (BMI', 'palmar-plantar erythrodysesthesia syndrome [known as hand-foot skin reaction (HFSR', 'HFSR', 'safety profile and AESIs', 'hypertension']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0222289', 'cui_str': 'Skin structure of foot'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",266.0,0.204187,"The treatment-related TEAE profile of fruquintinib in Chinese patents with mCRC was comparable among different subgroups and consistent with that reported in the overall population. ","[{'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, Tongji University East Hospital, Shanghai, China.'}, {'ForeName': 'Weijian', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': 'Department of Medical Oncology, Shanghai Medical College, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Yuxian', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Department of Medical Oncology, The Sixth Hospital Affiliated to Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Medical Oncology, Nantong Cancer Hospital, Nantong, China.'}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Oncology, The Second Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Haijun', 'Initials': 'H', 'LastName': 'Zhong', 'Affiliation': 'Department of Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Ruihua', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Hongming', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': 'Department of Medical Oncology, Sir Run Run Shaw Hospital, Hangzhou, China.'}, {'ForeName': 'Yongqian', 'Initials': 'Y', 'LastName': 'Shu', 'Affiliation': 'Department of Medical Oncology, Jiangsu Provincial Hospital, Nanjing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Medical Oncology, The Second Affiliated Hospital of Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Oncology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Nong', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, The First Affiliated Hospital Zhejiang University College of Medicine, Hangzhou, China.'}, {'ForeName': 'Tianshu', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Oncology, Fudan University Zhongshan Hospital, Shanghai, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': ""Department of Medical Oncology, Guangdong Provincial People's Hospital, Guangzhou, China.""}, {'ForeName': 'Changping', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': ""Department of Medical Oncology, The First People's Hospital of Changzhou, Changzhou, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Medical Oncology, Jilin Province Cancer Hospital, Changchun, China.'}, {'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, The Fifth Medical Center of Chinese, PLA General Hospital, Beijing, China.'}, {'ForeName': 'Donghui', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': ""Department of Medical Oncology, Shanghai Jiao Tong University Affiliated First People's Hospital, Shanghai, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Sanyuan', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'Department of Medical Oncology, Xuzhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Zhuang', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Department of Medical Oncology, The Affiliated Hospital of Medical College Qingdao University, Qingdao, China.'}, {'ForeName': 'Peiguo', 'Initials': 'P', 'LastName': 'Cao', 'Affiliation': 'Department of Medical Oncology, Xiangya Hospital of Central South University, The Third Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Haihui', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""Department of Medical Oncology, Liuzhou Worker's Hospital, Liuzhou, China.""}, {'ForeName': 'Shubin', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, Beijing University ShenZhen Hospital, Beijing University, Shenzhen, China.'}, {'ForeName': 'Hongbing', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, The Affiliated Hospital of Xuzhou Medical College, Xuzhou Medical College, Xuzhou, China.'}, {'ForeName': 'Songhua', 'Initials': 'S', 'LastName': 'Fan', 'Affiliation': 'Hutchison MediPharma Limited, Shanghai, China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Hutchison MediPharma Limited, Shanghai, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Lilly China, Drug Development and Medical Affairs Center, Shanghai, China.'}, {'ForeName': 'Rubing', 'Initials': 'R', 'LastName': 'Han', 'Affiliation': 'Lilly China, Drug Development and Medical Affairs Center, Shanghai, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Lilly China, Drug Development and Medical Affairs Center, Shanghai, China.'}, {'ForeName': 'Shukui', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': 'Cancer Center of Jinling Hospital, Nanjing, China. shukui_qin123@hotmail.com.'}]",Advances in therapy,['10.1007/s12325-020-01477-w'] 1320,32911132,A brief telephone-delivered peer intervention to encourage enrollment in medication for opioid use disorder in individuals surviving an opioid overdose: Results from a randomized pilot trial.,"BACKGROUND Medication for opioid use disorder (MOUD) can decrease the risk of opioid overdose (OOD) in individuals with opioid use disorder. Peer recovery support services (PRSS) are increasingly used to promote MOUD engagement but evidence of their efficacy is limited. This study's objective was to evaluate a single 20-minute telephone-delivered PRSS intervention for increasing MOUD enrollment and decreasing recurring OODs. METHOD This single-site, randomized controlled pilot trial enrolled adults, primarily recruited from a syringe service program, with an opioid-positive urine drug screen (UDS) reporting having been treated for an OOD within the past 6 months. Participants (N = 80) were randomized to PRSS (n = 40) or Control (n = 40) condition with all participants receiving personally-tailored OOD education and naloxone. Outcome measures obtained at 3 (n = 66), 6 (n = 58), and 12 (n = 44) months post-randomization included verified MOUD enrollment (primary), self-reported OOD, and opioid use assessed by self-report and UDS. RESULTS Through 12-month follow-up, 32.5 % of PRSS, compared to 17.5 % of Control participants enrolled in MOUD (X 2 = 2.4, p = 0.12; odds ratio = 2.27 (0.79-6.49)). PRSS participants were significantly less likely to have experienced an OOD through 12-month follow-up (12.5 % of PRSS participants, 32.5 % of Control, p = 0.03). No significant treatment effect was found for opioid use through 12-month follow-up as measured by either opioid-positive UDSs or self-reported past month opioid use days. Based on self-report, PRSS had good acceptability for both the interventionists and participants. CONCLUSIONS The results suggest that further development and testing of this PRSS telephone intervention to encourage MOUD enrollment and reduce OOD may be warranted.",2020,No significant treatment effect was found for opioid use through 12-month follow-up as measured by either opioid-positive UDSs or self-reported past month opioid use days.,"['individuals with opioid use disorder', 'Participants (N = 80', 'individuals surviving an opioid overdose', 'enrolled adults, primarily recruited from a syringe service program, with an opioid-positive urine drug screen (UDS) reporting having been treated for an OOD within the past 6 months']","['PRSS', 'PRSS telephone intervention', 'Control (n = 40) condition with all participants receiving personally-tailored OOD education and naloxone', 'Peer recovery support services (PRSS', 'telephone-delivered PRSS intervention', 'telephone-delivered peer intervention']","['verified MOUD enrollment (primary), self-reported OOD, and opioid use assessed by self-report and UDS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0743300', 'cui_str': 'Urine drug screen positive'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}]",80.0,0.0748964,No significant treatment effect was found for opioid use through 12-month follow-up as measured by either opioid-positive UDSs or self-reported past month opioid use days.,"[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA. Electronic address: winhusen@carc.uc.edu.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wilder', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Kropp', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Lyons', 'Affiliation': 'Department of Emergency Medicine, University of Cincinnati College of Medicine, 231 Albert Sabin Way, Cincinnati, OH, 45267, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108270'] 1321,32911462,On-Site Computed Tomography Versus Angiography Alone to Guide Coronary Stent Implantation: A Prospective Randomized Study.,"OBJECTIVES The effect of intraprocedural coronary computed tomography angiography (coronary CTA) guidance on percutaneous coronary intervention (PCI) is unknown. We sought to determine the influence of CTA guidance on procedural strategies and immediate angiographic outcomes of PCI. METHODS Sixty patients were randomized to CTA-guided PCI (29 patients, 36 lesions) or angiography-guided PCI (31 patients, 39 lesions). To enable hands-free manipulation of CTA images by the interventional cardiologist during PCI, we developed an onsite augmented-reality (AR) system comprising a mobile application and AR glass. The primary endpoints were defined as: (1) stent length; and (2) largest stent diameter according to compliance chart. Procedural strategies, two-dimensional (2D) and three-dimensional (3D) quantitative coronary angiography (QCA), and safety outcomes were compared. RESULTS Whereas CTA guidance resulted in significantly higher frequency of stent postdilation using non-compliant (67% vs 31%; P<.01) and shorter balloons (16.6 ± 5.4 mm vs 20.5 ± 9.4 mm; P=.04) with numerically larger diameter (3.50 ± 0.63 mm vs 3.28 ± 0.45 mm; P=.10), it did not differ from angiography guidance with respect to lesion predilation, stent length, largest stent diameter according to compliance chart, and nominal stent diameter. The results of 2D- and 3D-QCA and safety outcomes were similar between groups. Neither death nor stroke occurred in either group. CONCLUSIONS PCI under intraprocedural CTA guidance is associated with similar stent size selection and more frequent stent postdilation, resulting in comparable immediate angiographic and safety outcomes as compared with PCI under angiographic guidance alone.",2020,"CONCLUSIONS PCI under intraprocedural CTA guidance is associated with similar stent size selection and more frequent stent postdilation, resulting in comparable immediate angiographic and safety outcomes as compared with PCI under angiographic guidance alone.","['29 patients, 36 lesions) or', 'Sixty patients']","['angiography-guided PCI', 'CTA-guided PCI', 'intraprocedural coronary computed tomography angiography (coronary CTA) guidance', 'CTA guidance', 'Site Computed Tomography Versus Angiography Alone to Guide Coronary Stent Implantation']","['2D- and 3D-QCA and safety outcomes', 'death nor stroke', 'Procedural strategies, two-dimensional (2D) and three-dimensional (3D) quantitative coronary angiography (QCA), and safety outcomes', 'stent length; and (2) largest stent diameter according to compliance chart', 'frequency of stent postdilation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0687568', 'cui_str': 'Coronary artery stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0449462', 'cui_str': 'Length of stent'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",60.0,0.0852343,"CONCLUSIONS PCI under intraprocedural CTA guidance is associated with similar stent size selection and more frequent stent postdilation, resulting in comparable immediate angiographic and safety outcomes as compared with PCI under angiographic guidance alone.","[{'ForeName': 'Maksymilian P', 'Initials': 'MP', 'LastName': 'Opolski', 'Affiliation': 'Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Alpejska 42, 04-628 Warsaw, Poland. opolski.mp@gmail.com.'}, {'ForeName': 'Stefan P', 'Initials': 'SP', 'LastName': 'Schumacher', 'Affiliation': ''}, {'ForeName': 'Niels J W', 'Initials': 'NJW', 'LastName': 'Verouden', 'Affiliation': ''}, {'ForeName': 'Pepijn A', 'Initials': 'PA', 'LastName': 'van Diemen', 'Affiliation': ''}, {'ForeName': 'Bartosz A', 'Initials': 'BA', 'LastName': 'Borucki', 'Affiliation': ''}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Sprengers', 'Affiliation': ''}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'Everaars', 'Affiliation': ''}, {'ForeName': 'Ruben W', 'Initials': 'RW', 'LastName': 'de Winter', 'Affiliation': ''}, {'ForeName': 'Albert C', 'Initials': 'AC', 'LastName': 'van Rossum', 'Affiliation': ''}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Nap', 'Affiliation': ''}, {'ForeName': 'Michiel J', 'Initials': 'MJ', 'LastName': 'Bom', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Knaapen', 'Affiliation': ''}]",The Journal of invasive cardiology,[] 1322,32891709,Influence of n-acetylcysteine maintenance on the pharmacodynamic effects of oral ethanol.,"RATIONALE Glutamate systems play an important role in the abuse related effects of alcohol. n-Acetylcysteine, a drug that promotes glutamate homeostasis, attenuates a range of alcohol effects in preclinical models. OBJECTIVES This human laboratory study determined the influence of n-acetylcysteine maintenance on alcohol self-administration using a model predictive of treatment effectiveness, along with the subjective, performance and physiological effects of alcohol. We hypothesized that n-acetylcysteine would attenuate alcohol self-administration, as well as positive subjective effects of alcohol. METHODS Nine subjects with alcohol use disorder completed this within-subjects study. Subjects were maintained on placebo, 1.2 and 2.4 g n-acetylcysteine in random order on an outpatient basis. After five days of maintenance on the target dose, subjects completed overnight inpatient experimental sessions in which the pharmacodynamic effects of alcohol were determined. RESULTS Alcohol produced prototypic effects (e.g., increased breath alcohol concentration, increased ratings of Feel Drink). n-Acetylcysteine did not alter the effects of alcohol. CONCLUSIONS These results indicate that although n-acetylcysteine can safely be combined with alcohol, it does not attenuate the abuse related effects of alcohol and is unlikely to be an effective standalone alcohol use disorder treatment. However, considering study limitations, future work is needed to further understand whether and how n-acetylcysteine might be used as a treatment for alcohol use disorder (e.g., in combination with a behavioral treatment or another pharmacological agent).",2020,"RESULTS Alcohol produced prototypic effects (e.g., increased breath alcohol concentration, increased ratings of Feel Drink).",['Nine subjects with alcohol use disorder completed this within-subjects study'],"['placebo', 'oral ethanol']","['breath alcohol concentration, increased ratings of Feel Drink']","[{'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]","[{'cui': 'C0202306', 'cui_str': 'Ethanol measurement, breath'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]",9.0,0.012153,"RESULTS Alcohol produced prototypic effects (e.g., increased breath alcohol concentration, increased ratings of Feel Drink).","[{'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Stoops', 'Affiliation': 'Department of Behavioral Science, University of Kentucky College of Medicine, 1100 Veterans Drive, Medical Behavioral Science Building, Lexington, KY 40536-0086, USA; Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA; Department of Psychology, University of Kentucky College of Arts and Sciences, 171 Funkhouser Drive, Lexington, KY 40506-0044, USA; Center on Drug and Alcohol Research, University of Kentucky College of Medicine, 845 Angliana Ave, Lexington, KY 40508, USA. Electronic address: william.stoops@uky.edu.'}, {'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'Strickland', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD 21224, USA.'}, {'ForeName': 'Lon R', 'Initials': 'LR', 'LastName': 'Hays', 'Affiliation': 'Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA.'}, {'ForeName': 'Abner O', 'Initials': 'AO', 'LastName': 'Rayapati', 'Affiliation': 'Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Lile', 'Affiliation': 'Department of Behavioral Science, University of Kentucky College of Medicine, 1100 Veterans Drive, Medical Behavioral Science Building, Lexington, KY 40536-0086, USA; Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA; Department of Psychology, University of Kentucky College of Arts and Sciences, 171 Funkhouser Drive, Lexington, KY 40506-0044, USA.'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Rush', 'Affiliation': 'Department of Behavioral Science, University of Kentucky College of Medicine, 1100 Veterans Drive, Medical Behavioral Science Building, Lexington, KY 40536-0086, USA; Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA; Department of Psychology, University of Kentucky College of Arts and Sciences, 171 Funkhouser Drive, Lexington, KY 40506-0044, USA.'}]","Pharmacology, biochemistry, and behavior",['10.1016/j.pbb.2020.173037'] 1323,32914237,R0 resection following chemo (radio)therapy improves survival of primary inoperable pancreatic cancer patients. Interim results of the German randomized CONKO-007± trial.,"PURPOSE Chemotherapy with or without radiotherapy is the standard in patients with initially nonmetastatic unresectable pancreatic cancer. Additional surgery is in discussion. The CONKO-007 multicenter randomized trial examines the value of radiotherapy. Our interim analysis showed a significant effect of surgery, which may be relevant to clinical practice. METHODS One hundred eighty patients received induction chemotherapy (gemcitabine or FOLFIRINOX). Patients without tumor progression were randomized to either chemotherapy alone or to concurrent chemoradiotherapy. At the end of therapy, a panel of five independent pancreatic surgeons judged the resectability of the tumor. RESULTS Following induction chemotherapy, 126/180 patients (70.0%) were randomized to further treatment. Following study treatment, 36/126 patients (28.5%) underwent surgery; (R0: 25/126 [19.8%]; R1/R2/Rx [n = 11/126; 6.1%]). Disease-free survival (DFS) and overall survival (OS) were significantly better for patients with R0 resected tumors (median DFS and OS: 16.6 months and 26.5 months, respectively) than for nonoperated patients (median DFS and OS: 11.9 months and 16.5 months, respectively; p = 0.003). In the 25 patients with R0 resected tumors before treatment, only 6/113 (5.3%) of the recommendations of the panel surgeons recommended R0 resectability, compared with 17/48 (35.4%) after treatment (p < 0.001). CONCLUSION Tumor resectability of pancreatic cancer staged as unresectable at primary diagnosis should be reassessed after neoadjuvant treatment. The patient should undergo surgery if a resectability is reached, as this significantly improves their prognosis.",2021,"Disease-free survival (DFS) and overall survival (OS) were significantly better for patients with R0 resected tumors (median DFS and OS: 16.6 months and 26.5 months, respectively) than for nonoperated patients (median DFS and OS: 11.9 months and 16.5 months, respectively; p = 0.003).","['primary inoperable pancreatic cancer patients', '36/126 patients (28.5%) underwent surgery', '126/180 patients (70.0', 'patients with initially nonmetastatic unresectable pancreatic cancer', 'One hundred eighty patients received', 'Patients without tumor progression']","['chemotherapy alone or to concurrent chemoradiotherapy', 'induction chemotherapy (gemcitabine or FOLFIRINOX', 'Chemotherapy with or without radiotherapy', 'R0 resection following chemo (radio)therapy', 'radiotherapy']","['R0 resectability', 'Disease-free survival (DFS) and overall survival (OS']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0854776', 'cui_str': 'Pancreatic carcinoma non-resectable'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0178874', 'cui_str': 'Tumor progression'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C4742253', 'cui_str': 'folfirinox'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",180.0,0.0915041,"Disease-free survival (DFS) and overall survival (OS) were significantly better for patients with R0 resected tumors (median DFS and OS: 16.6 months and 26.5 months, respectively) than for nonoperated patients (median DFS and OS: 11.9 months and 16.5 months, respectively; p = 0.003).","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Fietkau', 'Affiliation': 'Department of Radiation Oncology, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany. rainer.fietkau@uk-erlangen.de.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Grützmann', 'Affiliation': 'Department of Surgery, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.'}, {'ForeName': 'U A', 'Initials': 'UA', 'LastName': 'Wittel', 'Affiliation': 'Department for General- and Visceral Surgery, Medical Center and Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Croner', 'Affiliation': 'Department of Surgery, University Hospital Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Jacobasch', 'Affiliation': 'Private practice, Hematology/Oncology, Dresden, Germany.'}, {'ForeName': 'U P', 'Initials': 'UP', 'LastName': 'Neumann', 'Affiliation': 'Department of Surgery, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Reinacher-Schick', 'Affiliation': 'Department for Hematology, Oncology and Palliative Care, St Josef-Hospital, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Imhoff', 'Affiliation': 'Department of Radiation Oncology, Universitätsklinikum Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Boeck', 'Affiliation': 'Department of Medical Oncology and Comprehensive Cancer Centre, Klinikum Grosshadern, Ludwig-Maximilians-University of Munich, Munich, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Keilholz', 'Affiliation': 'Department of Radiotherapy, Clinical Center Bayreuth, Bayreuth, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Oettle', 'Affiliation': 'Outpatient Department Hematology/Oncology, Friedrichshafen, Germany.'}, {'ForeName': 'W M', 'Initials': 'WM', 'LastName': 'Hohenberger', 'Affiliation': 'Department of Surgery, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Golcher', 'Affiliation': 'Department of Surgery, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.'}, {'ForeName': 'W O', 'Initials': 'WO', 'LastName': 'Bechstein', 'Affiliation': 'Department of General and Visceral Surgery, Frankfurt University Hospital and Clinics, Frankfurt, Germany.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Uhl', 'Affiliation': 'Department of Surgery, St. Josef Hospital, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pirkl', 'Affiliation': 'Medical Centre for Information and Communication Technology, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Adler', 'Affiliation': 'Department of Medical Informatics, Biometry and Epidemiology, University of Erlangen-Nürnberg, Waldstraße\xa06, 91054, Erlangen, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Semrau', 'Affiliation': 'Department of Radiation Oncology, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rutzner', 'Affiliation': 'Department of Radiation Oncology, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ghadimi', 'Affiliation': 'Department of General, Visceral and Pediatric Surgery, Medical Center, Georg-August-University Göttingen, Göttingen, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lubgan', 'Affiliation': 'Department of Radiation Oncology, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-020-01680-2'] 1324,32905615,Metronidazole and amoxicillin for patients with periodontitis and diabetes mellitus: 5-year secondary analysis of a randomized controlled trial.,"BACKGROUND The aim of this study was to perform a 5-year follow-up analysis of a previously-published randomized trial (RCT) evaluating the 2-years effects of metronidazole (MTZ) plus amoxicillin (AMX) as adjuncts to scaling and root planing (SRP) in the treatment of periodontitis in type 2 diabetic patients. METHODS Volunteers who received periodontal treatment in the aforementioned RCT were selected for clinical and microbiological evaluation. Patients did not receive regular supportive periodontal therapy (SPT) from 2 to 5 years post-treatment. RESULTS Of the patients enrolled in the RCT, 43% entered this study (n = 10/control and 15/test group). Most of clinical parameter values, including the number of sites with probing depth ≥ 5 mm (primary outcome variable), were reduced at 5 years post-therapy when compared with baseline in the antibiotic-treated group (P < 0.05), but presented higher values than those at 2 years (P < 0.05). The mean proportions of microbial complexes did not differ between MTZ+AMX+SRP and SRP-only groups at 5 years post-treatment (P > 0.05). CONCLUSION Diabetic patients treated with adjunctive MTZ+AMX were better maintained over a period of 5 years than those treated with SRP only. However, the clinical and microbiological benefits obtained up to 2 years post-treatment were not fully sustained in these patients who did not receive SPT between 2 and 5 years post-treatment.",2021,"The mean proportions of microbial complexes did not differ between MTZ+AMX+SRP and SRP-only groups at 5 years post-treatment (P > 0.05). ","['patients with periodontitis and diabetes mellitus', 'Diabetic patients treated with', 'Volunteers who received periodontal treatment in the aforementioned RCT were selected for clinical and microbiological evaluation', 'periodontitis in type 2 diabetic patients']","['adjunctive MTZ+AMX', 'regular supportive periodontal therapy (SPT', 'Metronidazole and amoxicillin', 'metronidazole (MTZ) plus amoxicillin (AMX', 'root planing (SRP', 'RCT']",['mean proportions of microbial complexes'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}]",,0.0568194,"The mean proportions of microbial complexes did not differ between MTZ+AMX+SRP and SRP-only groups at 5 years post-treatment (P > 0.05). ","[{'ForeName': 'Daniele Ferreira da', 'Initials': 'DFD', 'LastName': 'Cruz', 'Affiliation': 'Department of Periodontology, Dental Research Division, Guarulhos University, São Paulo, Brazil.'}, {'ForeName': 'Poliana Mendes', 'Initials': 'PM', 'LastName': 'Duarte', 'Affiliation': 'Department of Periodontology, Dental Research Division, Guarulhos University, São Paulo, Brazil.'}, {'ForeName': 'Luciene Cristina', 'Initials': 'LC', 'LastName': 'Figueiredo', 'Affiliation': 'Department of Periodontology, Dental Research Division, Guarulhos University, São Paulo, Brazil.'}, {'ForeName': 'Hélio Doyle Pereira', 'Initials': 'HDP', 'LastName': 'da Silva', 'Affiliation': 'Department of Periodontology, Dental Research Division, Guarulhos University, São Paulo, Brazil.'}, {'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Retamal-Valdes', 'Affiliation': 'Department of Periodontology, Dental Research Division, Guarulhos University, São Paulo, Brazil.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Feres', 'Affiliation': 'Department of Periodontology, Dental Research Division, Guarulhos University, São Paulo, Brazil.'}, {'ForeName': 'Tamires Szeremeske', 'Initials': 'TS', 'LastName': 'Miranda', 'Affiliation': 'Department of Periodontology, Dental Research Division, Guarulhos University, São Paulo, Brazil.'}]",Journal of periodontology,['10.1002/JPER.20-0196'] 1325,32896387,Re: Prajna et al.: Cross-Linking-Assisted Infection Reduction: a randomized clinical trial evaluating the effect of adjuvant cross-linking on outcomes in fungal keratitis (Ophthalmology. 2020;127:159-166).,,2021,,['fungal keratitis (Ophthalmology'],"['adjuvant cross-linking', ' Cross-Linking-Assisted Infection Reduction']",[],"[{'cui': 'C1262117', 'cui_str': 'Fungal keratitis'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",[],,0.139189,,"[{'ForeName': 'Deepali', 'Initials': 'D', 'LastName': 'Singhal', 'Affiliation': 'Institute of Vision and Optics, VEIC, University of Crete, Greece.'}, {'ForeName': 'Prafulla K', 'Initials': 'PK', 'LastName': 'Maharana', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India. Electronic address: drpraful13@gmail.com.'}]",Ophthalmology,['10.1016/j.ophtha.2020.07.010'] 1326,32897386,Assessment of Shared Decision-making for Stroke Prevention in Patients With Atrial Fibrillation: A Randomized Clinical Trial.,"Importance Shared decision-making (SDM) about anticoagulant treatment in patients with atrial fibrillation (AF) is widely recommended but its effectiveness is unclear. Objective To assess the extent to which the use of an SDM tool affects the quality of SDM and anticoagulant treatment decisions in at-risk patients with AF. Design, Setting, and Participants This encounter-randomized trial recruited patients with nonvalvular AF who were considering starting or reviewing anticoagulant treatment and their clinicians at academic, community, and safety-net medical centers between January 30, 2017 and June 27, 2019. Encounters were randomized to either the standard care arm or care that included the use of an SDM tool (intervention arm). Data were analyzed from August 1 to November 30, 2019. Interventions Standard care or care using the Anticoagulation Choice Shared Decision Making tool (which presents individualized risk estimates and compares anticoagulant treatment options across issues of importance to patients) during the clinical encounter. Main Outcomes and Measures Quality of SDM (which included quality of communication, patient knowledge about AF and anticoagulant treatment, accuracy of patient estimates of their own stroke risk [within 30% of their estimate], decisional conflict, and satisfaction), decisions made during the encounter, duration of the encounter, and clinician involvement of patients in the SDM process. Results The clinical trial enrolled 922 patients (559 men [60.6%]; mean [SD] age, 71 [11] years) and 244 clinicians. A total of 463 patients were randomized to the intervention arm and 459 patients to the standard care arm. Participants in both arms reported high communication quality, high knowledge, and low decisional conflict, demonstrated low accuracy in their risk perception, and would similarly recommend the approach used in their encounter. Clinicians were significantly more satisfied after intervention encounters (400 of 453 encounters [88.3%] vs 277 of 448 encounters [61.8%]; adjusted relative risk, 1.49; 95% CI, 1.42-1.53). A total of 747 of 873 patients (85.6%) chose to start or continue receiving an anticoagulant medication. Patient involvement in decision-making (as assessed through video recordings of the encounters using the Observing Patient Involvement in Decision Making 12-item scale) scores were significantly higher in the intervention arm (mean [SD] score, 33.0 [10.8] points vs 29.1 [13.1] points, respectively; adjusted mean difference, 4.2 points; 95% CI, 2.8-5.6 points). No significant between-arm difference was found in encounter duration (mean [SD] duration, 32 [16] minutes in the intervention arm vs 31 [17] minutes in the standard care arm; adjusted mean between-arm difference, 1.1; 95% CI, -0.3 to 2.5 minutes). Conclusion and Relevance The use of an SDM encounter tool improved several measures of SDM quality and clinician satisfaction, with no significant effect on treatment decisions or encounter duration. These results help to calibrate expectations about the value of implementing SDM tools in the care of patients with AF. Trial Registration ClinicalTrials.gov Identifier: NCT02905032.",2020,"The use of an SDM encounter tool improved several measures of SDM quality and clinician satisfaction, with no significant effect on treatment decisions or encounter duration.","['A total of 747 of 873 patients (85.6%) chose to start or continue receiving an anticoagulant medication', '922 patients (559 men [60.6', 'mean [SD] age, 71 [11] years) and 244 clinicians', '463 patients were randomized to the intervention arm and 459 patients to the standard care arm', 'patients with AF', 'patients with atrial fibrillation (AF', 'Patients With Atrial Fibrillation', 'patients with nonvalvular AF who were considering starting or reviewing anticoagulant treatment and their clinicians at academic, community, and safety-net medical centers between January 30, 2017 and June 27, 2019']",['standard care arm or care that included the use of an SDM tool (intervention arm'],"['Decision Making 12-item scale) scores', 'encounter duration', 'Measures\n\n\nQuality of SDM (which included quality of communication, patient knowledge about AF and anticoagulant treatment, accuracy of patient estimates of their own stroke risk [within 30% of their estimate], decisional conflict, and satisfaction), decisions made during the encounter, duration of the encounter, and clinician involvement of patients in the SDM process', 'SDM quality and clinician satisfaction']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C1277291', 'cui_str': 'Stroke risk'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C1522240', 'cui_str': 'Process'}]",922.0,0.0691682,"The use of an SDM encounter tool improved several measures of SDM quality and clinician satisfaction, with no significant effect on treatment decisions or encounter duration.","[{'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Kunneman', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Branda', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Ian G', 'Initials': 'IG', 'LastName': 'Hargraves', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Angela L', 'Initials': 'AL', 'LastName': 'Sivly', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Alexander T', 'Initials': 'AT', 'LastName': 'Lee', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Haeshik', 'Initials': 'H', 'LastName': 'Gorr', 'Affiliation': 'Division of General Internal Medicine, Hennepin Health, Minneapolis, Minnesota.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Burnett', 'Affiliation': 'Thrombosis Clinic and Anticoagulation Services, Park Nicollet Health Services, St Louis Park, Minnesota.'}, {'ForeName': 'Takeki', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Mississippi Medical Center, Jackson.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Jackson', 'Affiliation': 'Department of Internal Medicine, Division of Cardiovascular Disease, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hess', 'Affiliation': 'Department of Emergency Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Linzer', 'Affiliation': 'Division of General Internal Medicine, Hennepin Health, Minneapolis, Minnesota.'}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Brand-McCarthy', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Brito', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Noseworthy', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Montori', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA internal medicine,['10.1001/jamainternmed.2020.2908'] 1327,30659284,"Better mind, better work: effects of plants on adolescent mental stress as measured by EEG.",,2019,,[],[],['adolescent mental stress'],[],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}]",,0.016105,,"[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Hassan', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu, Sichuan, 611130, China. ahmaduaf1416@gmail.com.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Tao', 'Affiliation': 'College of Forestry, Guizhou University, Huaxi, Guiyang, 550025, China.'}, {'ForeName': 'Chen Qi', 'Initials': 'CQ', 'LastName': 'Bing', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu, Sichuan, 611130, China. cqb@sicau.edu.cn.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Yinggao', 'Affiliation': 'College of Forestry, Sichuan Agricultural University, Chengdu, Sichuan, 611130, China. 499130793@qq.com.'}, {'ForeName': 'Guo', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu, Sichuan, 611130, China.'}, {'ForeName': 'Mingyan', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu, Sichuan, 611130, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Nian', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu, Sichuan, 611130, China.'}, {'ForeName': 'Lv', 'Initials': 'L', 'LastName': 'Bing-Yang', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu, Sichuan, 611130, China.'}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-019-0209-7'] 1328,32914838,Evaluation of a Text Messaging-Based Human Papillomavirus Vaccination Intervention for Young Sexual Minority Men: Results from a Pilot Randomized Controlled Trial.,"BACKGROUND Men who have sex with men (MSM) are at high risk for human papillomavirus (HPV) infection and HPV-related anal cancer. Although a safe and effective vaccine is available to prevent HPV infection, HPV vaccine uptake among young MSM remains low. PURPOSE This pilot randomized controlled trial tested the acceptability, feasibility, and preliminary efficacy of a text messaging-based HPV vaccination intervention for young sexual minority men. METHODS In 2018, unvaccinated sexual minority men aged 18-25 years were recruited from Chicago to participate in a 9 month sexual health program called txt2protect. Participants (N = 150) were randomized to the intervention or control condition. Intervention condition messages focused primarily on HPV vaccination, with only a brief mention of other sexual health practices (e.g., condom use and HIV testing), while control condition messages focused on a variety of sexual health practices with only a brief mention of HPV vaccination. Participants received daily text messages for the first 3 weeks and monthly text messages for the remaining ~8 months of the trial. Participants completed surveys at baseline and 3 week and 9 month follow-ups. RESULTS Participants reported high satisfaction with the intervention. Although trial retention was high (with over 88% completing the 9 month survey), the study fell short of meeting its recruitment goal. HPV vaccine series initiation was significantly higher among intervention participants (19.4%) compared to control participants (6.6%), odds ratio = 3.43, 95% confidence interval: 1.17, 10.08. CONCLUSIONS Findings suggest that txt2protect is an acceptable and potentially promising intervention for increasing HPV vaccine initiation among young sexual minority men. CLINICAL TRIAL REGISTRATION NCT02994108.",2021,HPV vaccine series initiation was significantly higher among intervention participants (19.4%) compared to control participants (6.6%),"['young sexual minority men', 'Participants (N = 150', 'Young Sexual Minority Men', '2018, unvaccinated sexual minority men aged 18-25 years were recruited from Chicago to participate in a 9 month sexual health program called txt2protect', 'Men who have sex with men (MSM']","['Intervention condition messages focused primarily on HPV vaccination, with only a brief mention of other sexual health practices (e.g., condom use and HIV testing), while control condition messages focused on a variety of sexual health practices with only a brief mention of HPV vaccination', 'Text Messaging-Based Human Papillomavirus Vaccination Intervention', 'text messaging-based HPV vaccination intervention']",['HPV vaccine series initiation'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C4277573', 'cui_str': 'Lesbigay Persons'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]",150.0,0.217267,HPV vaccine series initiation was significantly higher among intervention participants (19.4%) compared to control participants (6.6%),"[{'ForeName': 'Mary A', 'Initials': 'MA', 'LastName': 'Gerend', 'Affiliation': 'Department of Behavioral Sciences and Social Medicine, College of Medicine, Florida State University, Tallahassee, FL, USA.'}, {'ForeName': 'Krystal', 'Initials': 'K', 'LastName': 'Madkins', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Shariell', 'Initials': 'S', 'LastName': 'Crosby', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Aaron K', 'Initials': 'AK', 'LastName': 'Korpak', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Phillips', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bass', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Houlberg', 'Affiliation': 'Howard Brown Health, Chicago, IL, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Mustanski', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa056'] 1329,32910030,Comparison of Fractional Picosecond 1064-nm Laser and Fractional Carbon Dioxide Laser for Treating Atrophic Acne Scars: A Randomized Split-Face Trial.,"BACKGROUND To date, no studies have compared the fractional picosecond 1064-nm laser (FxPico) and fractional carbon dioxide laser (FxCO2) for the treatment of acne scars. OBJECTIVE To compare the efficacy and safety between FxPico and FxCO2 for treating facial atrophic acne scars. MATERIALS AND METHODS Twenty-five Asian patients with mild to moderate atrophic acne scars underwent single sessions of randomized split-face treatment with FxPico and FxCO2. Clinical efficacy was assessed by photographs, skin imaging analysis, and patient satisfaction. The adverse events were recorded on every visit. Skin biopsies were performed immediately and 3 months after treatment. RESULTS The physician improvement scores for skin texture and atrophy significantly increased on the FxPico sides, but no significant difference was observed between FxPico and FxCO2. Skin imaging also showed significant improvement on both sides for scar volume. Postinflammatory hyperpigmentation (PIH) was not reported on FxPico sides, whereas 6 patients (24%) experienced mild PIH on FxCO2 sides. Immediate post-FxPico skin biopsy revealed laser-induced optical breakdown with photoacoustic columns. Collagen and elastic fibers increased at 3 months after both treatments. CONCLUSION FxPico was as effective as FxCO2 in treating atrophic acne scars, correlating with evidence of tissue remodeling with more safety profiles.",2021,"The physician improvement scores for skin texture and atrophy significantly increased on the FxPico sides, but no significant difference was observed between FxPico and FxCO2.","['Atrophic Acne Scars', 'facial atrophic acne scars', 'Twenty-five Asian patients with mild to moderate atrophic acne scars underwent']","['FxPico and FxCO2', 'single sessions of randomized split-face treatment with FxPico and FxCO2', 'FxPico', 'fractional picosecond 1064-nm laser (FxPico) and fractional carbon dioxide laser (FxCO2', 'Fractional Picosecond 1064-nm Laser and Fractional Carbon Dioxide Laser']","['Skin biopsies', 'Collagen and elastic fibers', 'efficacy and safety', 'Postinflammatory hyperpigmentation (PIH', 'adverse events', 'skin texture and atrophy', 'Clinical efficacy']","[{'cui': 'C1274728', 'cui_str': 'Atrophic acne scar'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}]","[{'cui': 'C0150866', 'cui_str': 'Biopsy of skin'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0230899', 'cui_str': 'Elastic fiber'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0333616', 'cui_str': 'Postinflammatory hyperpigmentation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0423752', 'cui_str': 'Finding of skin texture'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}]",25.0,0.0327362,"The physician improvement scores for skin texture and atrophy significantly increased on the FxPico sides, but no significant difference was observed between FxPico and FxCO2.","[{'ForeName': 'Punyaphat', 'Initials': 'P', 'LastName': 'Sirithanabadeekul', 'Affiliation': 'Department of Dermatology, Chulabhorn International College of Medicine, Thammasat University, Pathum Thani, Thailand.'}, {'ForeName': 'Ploypailin', 'Initials': 'P', 'LastName': 'Tantrapornpong', 'Affiliation': 'Department of Dermatology, Chulabhorn International College of Medicine, Thammasat University, Pathum Thani, Thailand.'}, {'ForeName': 'Bheeratida', 'Initials': 'B', 'LastName': 'Rattakul', 'Affiliation': 'Samitivej Esthetic Institute, Samitivej Sukhumvit Hospital, Bangkok, Thailand.'}, {'ForeName': 'Nalinee', 'Initials': 'N', 'LastName': 'Sutthipisal', 'Affiliation': 'Samitivej Esthetic Institute, Samitivej Sukhumvit Hospital, Bangkok, Thailand.'}, {'ForeName': 'Wilai', 'Initials': 'W', 'LastName': 'Thanasarnaksorn', 'Affiliation': 'Samitivej Esthetic Institute, Samitivej Sukhumvit Hospital, Bangkok, Thailand.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002572'] 1330,32911319,"A randomized pilot study assessing the acceptability of rapid point-of-care hepatitis C virus (HCV) testing among male inmates in Montreal, Canada.","BACKGROUND The Oraquick Ⓡ fingerprick point-of-care hepatitis C virus antibody (HCV-Ab) test is favoured to venipuncture among people who inject drugs; however, its acceptability in prison populations is unknown. We aimed to compare the acceptability of the Oraquick Ⓡ versus standard venipuncture among people in prison. METHODS From October to December 2019, 280 sentenced male inmates at L'Établissement de Détention de Montréal (Quebec, Canada) were screened for participation, 150 excluded due to prior HCV screening, and 52 refused participation. The remaining 78 were randomized 1:1 to opt-out HCV-Ab screening with OraQuick Ⓡ or venipuncture (n = 39 each). Acceptability was determined by the proportion accepting to undergo screening. RESULTS The majority of participants (median age 33 years) reported a history of drug use (76%; 8% injection drug use); 47% perceived their HCV risk to be moderate/high. All inmates randomized to Oraquick Ⓡ accepted testing while 87% accepted venipuncture. Among those who accepted Oraquick Ⓡ vs. venipuncture, 100% vs. 97% were satisfied with the test, 97% vs. 94% would recommend the same test, and 100% vs. 76% would choose the same test again. CONCLUSION Adult incarcerated men in Canada were both more likely to accept Oraquick Ⓡ compared to venipuncture, and to choose Oraquick Ⓡ for future HCV screening.",2020,"CONCLUSION Adult incarcerated men in Canada were both more likely to accept Oraquick Ⓡ compared to venipuncture, and to choose Oraquick Ⓡ for future HCV screening.","[""From October to December 2019, 280 sentenced male inmates at L'Établissement de Détention de Montréal (Quebec, Canada) were screened for participation, 150 excluded due to prior HCV screening, and 52 refused participation"", 'people in prison', 'male inmates in Montreal, Canada', 'Adult incarcerated men in Canada']","['rapid point-of-care hepatitis C virus (HCV', 'venipuncture', 'Ⓡ or venipuncture', 'HCV-Ab screening with OraQuick', 'Oraquick Ⓡ versus standard venipuncture']",['Acceptability'],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0017095', 'cui_str': 'Trash'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0392751', 'cui_str': 'In prison'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0190979', 'cui_str': 'Phlebotomy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",280.0,0.0431789,"CONCLUSION Adult incarcerated men in Canada were both more likely to accept Oraquick Ⓡ compared to venipuncture, and to choose Oraquick Ⓡ for future HCV screening.","[{'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Kronfli', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University, Montreal, Quebec, Canada; Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada. Electronic address: nadine.kronfli@mcgill.ca.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Dussault', 'Affiliation': 'Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Chalifoux', 'Affiliation': 'Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Hasmig', 'Initials': 'H', 'LastName': 'Kavoukian', 'Affiliation': 'Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Marina B', 'Initials': 'MB', 'LastName': 'Klein', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University, Montreal, Quebec, Canada; Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada; CIHR Canadian HIV Trials Network, Vancouver, Canada.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Cox', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University, Montreal, Quebec, Canada; Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada.'}]",The International journal on drug policy,['10.1016/j.drugpo.2020.102921'] 1331,32918512,Physicians' very brief (30-sec) intervention for smoking cessation on 13 671 smokers in China: a pragmatic randomized controlled trial.,"BACKGROUND AND AIMS Three to 10 minutes of smoking cessation advice by physicians is effective to increase quit rates, but is not routinely practised. We examined the effectiveness of physicians' very brief (approximately 30 sec) smoking cessation intervention on quit rates among Chinese outpatient smokers. DESIGN A pragmatic, open-label, individually randomized controlled trial. SETTING Seventy-two medical outpatient departments of hospitals and/or community health centers in Guangdong, China. PARTICIPANTS Chinese adults who were daily cigarette smokers (n = 13 671, 99% males) were invited by their physician to participate during outpatient consultation. Smokers who were receiving smoking cessation treatment or were judged to need specialist treatment for cessation were excluded. INTERVENTIONS The intervention group (n = 7015) received a 30-sec intervention including physician's very brief advice, a leaflet with graphic warnings and a card with contact information of available cessation services. The control group (n = 6656) received a very brief intervention on consuming vegetables and fruit. A total of 3466 participants in the intervention group were further randomized to receive a brief booster advice from trained study personnel via telephone 1 month following their doctor visit. MEASUREMENTS The primary outcome was self-reported 7-day point prevalence abstinence (PPA) in the intervention and control groups at the 12-month follow-up. Secondary outcomes included self-reported 30-day abstinence and biochemically validated abstinence at 12-month follow-up. FINDINGS By intention-to-treat, the intervention (versus control) group had greater self-reported 7-day abstinence [9.1 versus 7.8%, odds ratio (OR) = 1.14, 95% confidence interval (CI) = 1.03-1.26, P = 0.008] and 30-day abstinence (8.0 versus 6.9%, OR = 1.14, 95% CI = 1.03-1.27, P = 0.01) at 12-month follow-up. The effect size increased when only participants who received the intervention from compliant physicians were included (7-day PPA, OR = 1.42, 95% CI = 1.11-1.74). The group difference in biochemically validated abstinence was small (0.8 versus 0.8%, OR = 1.00, 95% CI = 0.71-1.42, P = 0.99). CONCLUSION A 30-sec smoking cessation intervention increased self-reported abstinence among mainly male smokers in China at 12-month follow-up (risk difference = 1.3%), and should be feasible to provide in most settings and delivered by all health-care professionals.",2021,A 30-second smoking cessation intervention increased self-reported abstinence among mainly male smokers in China at 12-month follow-up (risk difference = 1.3%) and should be feasible to provide in most settings and delivered by all healthcare professionals.,"['13,671 smokers in China', 'Chinese outpatient smokers', '3,466 participants in the intervention group', 'mainly male smokers', 'Smokers who were receiving smoking cessation treatment or were judged to needed specialist treatment for cessation were excluded', 'Seventy-two medical outpatient departments of hospitals', 'Chinese adults who were daily cigarette smokers (N = 13,671, 99% males) were invited by their physician to participate during outpatient consultation', 'and/or community health centers in Guangdong, China']","[""physicians' very brief (about 30 seconds) smoking cessation intervention"", '30-second smoking cessation intervention', 'very brief intervention on consuming vegetables and fruits', 'brief booster advice from trained study personnel through telephone one month following their doctor visit', ""30-second intervention including physician's very brief advice, a leaflet with graphic warnings, and a card with contact information of available cessation services""]","['quit rates', '30-day abstinence', 'self-reported abstinence', 'self-reported 7-day point prevalence abstinence', 'effect size', 'self-reported 30-day abstinence and biochemically validated abstinence at 12-month follow-up', 'greater self-reported 7-day abstinence']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0221191', 'cui_str': 'Judge'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}]","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1692317', 'cui_str': 'Smoking cessation assistance'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205393', 'cui_str': 'Most'}]",3466.0,0.0775531,A 30-second smoking cessation intervention increased self-reported abstinence among mainly male smokers in China at 12-month follow-up (risk difference = 1.3%) and should be feasible to provide in most settings and delivered by all healthcare professionals.,"[{'ForeName': 'Yee Tak Derek', 'Initials': 'YTD', 'LastName': 'Cheung', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Jiang', 'Affiliation': 'Department of Population Health, Grossman School of Medicine, New York University, New York, NY, USA.'}, {'ForeName': 'Chao Qiang', 'Initials': 'CQ', 'LastName': 'Jiang', 'Affiliation': 'Guangzhou No. 12 Hospital, Guangzhou Guangdong Province, China.'}, {'ForeName': 'Run Sen', 'Initials': 'RS', 'LastName': 'Zhuang', 'Affiliation': 'Shenzhen Health Education and Promotion Centre, Shenzhen, China.'}, {'ForeName': 'Wen Hui', 'Initials': 'WH', 'LastName': 'Gao', 'Affiliation': 'Shenzhen Health Education and Promotion Centre, Shenzhen, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Respiratory Medicine, Guangzhou Medical University Second Affiliated Hospital, Guangzhou, China.'}, {'ForeName': 'Jin Hong', 'Initials': 'JH', 'LastName': 'Lu', 'Affiliation': 'Traditional Chinese Medical Hospital of Huangpu, Guangzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Shenzhen Bao'an District Songgang People's Hospital, Hongqiaotou Community Health Service Center, Shenzhen, China.""}, {'ForeName': 'Jun Feng', 'Initials': 'JF', 'LastName': 'Wang', 'Affiliation': 'The Fifth Affiliated Hospital of Sun Yat-sen University, Zhongshang, China.'}, {'ForeName': 'Yi Sheng', 'Initials': 'YS', 'LastName': 'Lai', 'Affiliation': 'Shenzhen Longgang District Central Hospital, Shenzhen, China.'}, {'ForeName': 'Jun Sheng', 'Initials': 'JS', 'LastName': 'Sun', 'Affiliation': 'Shenzhen Longgang District Central Hospital, Shenzhen, China.'}, {'ForeName': 'Jiu Chang', 'Initials': 'JC', 'LastName': 'Wu', 'Affiliation': ""Shenzhen Bao'an District Fuyong Hospital, Shenzhen, China.""}, {'ForeName': 'Chiang', 'Initials': 'C', 'LastName': 'Ye', 'Affiliation': ""Division of Endocrinology, Shenzhen Bao'an District People's Hospital, Shenzhen, China.""}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Shenzhen Longgang District Central Hospital, Shenzhen, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Zhou', 'Affiliation': 'Guangzhou No. 12 Hospital, Guangzhou Guangdong Province, China.'}, {'ForeName': 'Jing Ying', 'Initials': 'JY', 'LastName': 'Chen', 'Affiliation': ""Shenzhen Longgang District Second People's Hospital, Shenzhen, China.""}, {'ForeName': 'Xiu Yan', 'Initials': 'XY', 'LastName': 'Ou', 'Affiliation': ""ZhongShan City People's Hospital, ZhongShan, China.""}, {'ForeName': 'Liu Qing', 'Initials': 'LQ', 'LastName': 'Liu', 'Affiliation': ""Longhua District People's Hospital Yansong Community Center, Shenzhen, China.""}, {'ForeName': 'Zhuang Hong', 'Initials': 'ZH', 'LastName': 'Huang', 'Affiliation': 'The First Affiliated Hospital of Shantou University Medical College Guan Bu Zhai Mei Healthcare Station, Shantou, China.'}, {'ForeName': 'Sai Yin', 'Initials': 'SY', 'LastName': 'Ho', 'Affiliation': 'School of Public Health, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Ho Cheung William', 'Initials': 'HCW', 'LastName': 'Li', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Sheng Hua', 'Initials': 'SH', 'LastName': 'Su', 'Affiliation': 'Health Care Center for Cadre of Guangdong Province, Guangzhou, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Tobacco Control Office, Chinese Center for Disease Control and Prevention, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Tobacco Control Office, Chinese Center for Disease Control and Prevention, China.'}, {'ForeName': 'Wei Hua', 'Initials': 'WH', 'LastName': 'Zhu', 'Affiliation': 'Guangzhou No. 12 Hospital, Guangzhou Guangdong Province, China.'}, {'ForeName': 'Lie', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Guangzhou No. 12 Hospital, Guangzhou Guangdong Province, China.'}, {'ForeName': 'Peiru', 'Initials': 'P', 'LastName': 'Lin', 'Affiliation': ""Guangzhou\xa0First Municipal People's Hospital,\xa0Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Institute of Geriatrics, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Kar Keung', 'Initials': 'KK', 'LastName': 'Cheng', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, UK.'}, {'ForeName': 'Tai Hing', 'Initials': 'TH', 'LastName': 'Lam', 'Affiliation': 'School of Public Health, The University of Hong Kong, Hong Kong, China.'}]","Addiction (Abingdon, England)",['10.1111/add.15262'] 1332,32918555,Bone marrow stimulation for talar osteochondral lesions at long-term follow-up shows a high sports participation though a decrease in clinical outcomes over time.,"PURPOSE Although bone marrow stimulation (BMS) as a treatment for osteochondral lesions of the talus (OCLT) shows high rates of sport resumption at short-term follow-up, it is unclear whether the sports activity is still possible at longer follow-up. The purpose of this study was, therefore, to evaluate sports activity after arthroscopic BMS at long-term follow-up. METHODS Sixty patients included in a previously published randomized-controlled trial were analyzed in the present study. All patients had undergone arthroscopic debridement and BMS for OCLT. Return to sports, level, and type were assessed in the first year post-operative and at final follow-up. Secondary outcome measures were assessed by standardized questionnaires with use of numeric rating scales for pain and satisfaction and the Foot and Ankle Outcome Score (FAOS). RESULTS The mean follow-up was 6.4 years (SD ± 1.1 years). The mean level of activity measured with the AAS was 6.2 pre-injury and 3.4 post-injury. It increased to 5.2 at 1 year after surgery and was 5.8 at final follow-up. At final follow-up, 54 patients (90%) participated in 16 different sports. Thirty-three patients (53%) indicated they returned to play sport at their pre-injury level. Twenty patients (33%) were not able to obtain their pre-injury level of sport because of ankle problems and eight other patients (13%) because of other reasons. Mean NRS for pain during rest was 2.7 pre-operative, 1.1 at 1 year, and 1.0 at final follow-up. Mean NRS during activity changed from 7.9 to 3.7 to 4.4, respectively. The FAOS scores improved at 1 year follow-up, but all subscores significantly decreased at final follow-up. CONCLUSION At long-term follow-up (mean 6.4 years) after BMS for OCLT, 90% of patients still participate in sports activities, of whom 53% at pre-injury level. The AAS of the patients participating in sports remains similar pre-injury and post-operatively at final follow-up. A decrease over time in clinical outcomes was, however, seen when the follow-up scores at 1 year post-operatively were compared with the final follow-up. LEVEL OF EVIDENCE Level II.",2021,"The FAOS scores improved at 1 year follow-up, but all subscores significantly decreased at final follow-up. ","['Sixty patients', 'All patients had undergone arthroscopic debridement and BMS for OCLT', '54 patients (90%) participated in 16 different sports']","['bone marrow stimulation (BMS', 'Bone marrow stimulation']","['mean level of activity', 'Mean NRS during activity', 'Mean NRS for pain', 'standardized questionnaires with use of numeric rating scales for pain and satisfaction and the Foot and Ankle Outcome Score (FAOS', 'FAOS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0038039', 'cui_str': 'Sport'}]","[{'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.0488496,"The FAOS scores improved at 1 year follow-up, but all subscores significantly decreased at final follow-up. ","[{'ForeName': 'Kaj T A', 'Initials': 'KTA', 'LastName': 'Lambers', 'Affiliation': 'Department of Orthopaedic Surgery, Academic Medical Center, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, 1105 AZ, The Netherlands.'}, {'ForeName': 'Jari', 'Initials': 'J', 'LastName': 'Dahmen', 'Affiliation': 'Department of Orthopaedic Surgery, Academic Medical Center, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, 1105 AZ, The Netherlands.'}, {'ForeName': 'J Nienke', 'Initials': 'JN', 'LastName': 'Altink', 'Affiliation': 'Department of Orthopaedic Surgery, Academic Medical Center, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, 1105 AZ, The Netherlands.'}, {'ForeName': 'Mikel L', 'Initials': 'ML', 'LastName': 'Reilingh', 'Affiliation': 'Academic Center for Evidence Based Sports Medicine (ACES), Amsterdam, The Netherlands.'}, {'ForeName': 'Christiaan J A', 'Initials': 'CJA', 'LastName': 'van Bergen', 'Affiliation': 'Academic Center for Evidence Based Sports Medicine (ACES), Amsterdam, The Netherlands.'}, {'ForeName': 'Gino M M J', 'Initials': 'GMMJ', 'LastName': 'Kerkhoffs', 'Affiliation': 'Department of Orthopaedic Surgery, Academic Medical Center, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, 1105 AZ, The Netherlands. g.m.kerkhoffs@amsterdamumc.nl.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-020-06250-8'] 1333,32898050,Do Women Who Self-report More Exercise Have Increased Rates of Symptomatic Stress Urinary Incontinence After Midurethral Slings?,"OBJECTIVES There is a paucity of data on postoperative exercise and how it relates to surgical failure, specifically after midurethral sling (MUS) surgery. We aimed to assess if women with higher self-reported activity levels as measured by strenuous exercise are more likely to experience stress urinary incontinence (SUI) symptoms after MUS than women with lower self-reported activity. METHODS This is a secondary analysis of Operations and Pelvic Muscle Training in the Management of Apical Support Loss: the OPTIMAL Trial, a randomized trial comparing sacrospinous ligament suspension versus uterosacral ligament suspension, both with concomitant retropubic MUS. Participants completed a validated assessment of activity preoperatively and postoperatively. Women in the upper quartile for strenuous exercise (≥90 minutes per week) were compared with the remaining participants. Symptomatic SUI was defined as retreatment or reoperation for SUI and/or any positive response to Pelvic Floor Disorders Inventory stress incontinence questions 20 to 22. RESULTS A total of 351 participants in the OPTIMAL study received MUS along with their prolapse repair and had postoperative exercise and Pelvic Floor Disorders Inventory data. At 2 years, 87 (29%) of 305 exercised strenuously for at least 90 minutes per week, and 63 (23%) of 277 experienced SUI. Women who were less active at 2 years were significantly more likely to experience SUI than women who were more active (26.6% vs 12.8%, P = 0.0138). CONCLUSIONS In this study, symptomatic SUI occurred more frequently in women with lower self-reported exercise levels 2 years after MUS surgery.",2021,"At 2 years, 87 (29%) of 305 exercised strenuously for at least 90 minutes per week, and 63 (23%) of 277 experienced SUI.",['351 participants in the OPTIMAL study received MUS along with their prolapse repair and had postoperative exercise and Pelvic Floor Disorders Inventory data'],"['strenuous exercise', 'Pelvic Muscle Training', 'sacrospinous ligament suspension versus uterosacral ligament suspension, both with concomitant retropubic MUS']","['symptomatic SUI', 'Symptomatic Stress Urinary Incontinence']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3179501', 'cui_str': 'Mid-Urethral Slings'}, {'cui': 'C0856413', 'cui_str': 'Prolapse repair'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3178892', 'cui_str': 'Pelvic Floor Diseases'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0448421', 'cui_str': 'Skeletal muscle structure of pelvis'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0225049', 'cui_str': 'Structure of sacrospinous ligament'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0230306', 'cui_str': 'Structure of uterosacral ligament'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0205499', 'cui_str': 'Retropubic approach'}, {'cui': 'C3179501', 'cui_str': 'Mid-Urethral Slings'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}]",351.0,0.0541035,"At 2 years, 87 (29%) of 305 exercised strenuously for at least 90 minutes per week, and 63 (23%) of 277 experienced SUI.","[{'ForeName': 'Kimberly L', 'Initials': 'KL', 'LastName': 'Ferrante', 'Affiliation': 'From the Division of Urogynecology, Kaiser Permanente San Diego, San Diego, CA.'}, {'ForeName': 'Marie G', 'Initials': 'MG', 'LastName': 'Gantz', 'Affiliation': 'Center for Clinical Research Network Coordination, Biostatistics and Epidemiology Division, RTI International, Research Triangle Park, NC.'}, {'ForeName': 'Amaanti', 'Initials': 'A', 'LastName': 'Sridhar', 'Affiliation': 'Center for Clinical Research Network Coordination, Biostatistics and Epidemiology Division, RTI International, Research Triangle Park, NC.'}, {'ForeName': 'Ariana', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Division of Urology, University of Pennsylvania Health System, Philadelphia, PA.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Rahn', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Ellington', 'Affiliation': 'Division of Urogynecology and Pelvic Reconstructive Surgery, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Alison C', 'Initials': 'AC', 'LastName': 'Weidner', 'Affiliation': 'Division of Urogynecology and Reconstructive Pelvic Surgery, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Wohlrab', 'Affiliation': 'Department of Obstetrics and Gynecology, Women and Infants Hospital, Warren Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Mazloomdoost', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Moalli', 'Affiliation': ""Division of Urogynecology and Pelvic Reconstructive Surgery, Magee Women's Hospital, University of Pittsburgh Medical Center, Pittsburgh, PA.""}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Lukacz', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, University of California, San Diego, San Diego, CA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Female pelvic medicine & reconstructive surgery,['10.1097/SPV.0000000000000893'] 1334,32906032,The MUC5B promoter variant does not predict progression of interstitial lung disease in systemic sclerosis.,"OBJECTIVE To investigate the prevalence of the MUC5B promoter variant rs35705950 in patients with systemic sclerosis-interstitial lung disease (SSc-ILD) and whether its presence predicts response to immunosuppression with cyclophosphamide (CYC) and mycophenolate (MMF). METHODS SSc-ILD patients who participated in Scleroderma Lung Study (SLS) II (MMF versus CYC) were included in this study (N = 142). TaqMan Genotyping Assays were used to determine the MUC5B rs35705950 single nucleotide polymorphism. Joint models were created to examine how the presence of this variant affected the course of the forced vital capacity (FVC) over 2 years. Linear regression models were used to investigate the relationship between the presence of this variant and the change in quantitative radiographic fibrosis. RESULTS Among 128 participants who were tested for this variant, 18% possessed at least one copy of the MUC5B minor allele. Patients with at least one copy of this allele were similar to those without the allele with respect to age, sex, SSc subtype, ILD disease severity; however, this variant was rare among African Americans (3.7%). The presence of the MUC5B variant did not affect the course of the FVC, nor the change in quantitative radiographic fibrosis, ground glass or ILD scores in either treatment arm. CONCLUSION In the context of a randomized controlled trial for SSc-ILD, the presence of the MUC5B variant did not predict disease severity, nor affect treatment response to MMF or CYC. Future studies are needed to determine whether this variant affects ILD progression in other SSc cohorts and in patients receiving anti-fibrotic therapy.",2020,"Patients with at least one copy of this allele were similar to those without the allele with respect to age, sex, SSc subtype, ILD disease severity; however, this variant was rare among African Americans (3.7%).","['patients with systemic sclerosis-interstitial lung disease (SSc-ILD', '128 participants who were tested for this variant, 18% possessed at least one copy of the MUC5B minor allele', 'SSc-ILD patients who participated in Scleroderma Lung Study (SLS) II (MMF versus CYC) were included in this study (N\u202f=\u202f142']","['MUC5B promoter variant rs35705950', 'cyclophosphamide (CYC) and mycophenolate (MMF']","['quantitative radiographic fibrosis, ground glass or ILD scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0537987', 'cui_str': 'Mucin-5 Subtype B, Tracheobronchial'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0083765', 'cui_str': 'NMF protocol'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0537987', 'cui_str': 'Mucin-5 Subtype B, Tracheobronchial'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}, {'cui': 'C0083765', 'cui_str': 'NMF protocol'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0532196,"Patients with at least one copy of this allele were similar to those without the allele with respect to age, sex, SSc subtype, ILD disease severity; however, this variant was rare among African Americans (3.7%).","[{'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Volkmann', 'Affiliation': 'Department of Medicine, University of California, Los Angeles, David Geffen School of Medicine, USA. Electronic address: evolkmann@mednet.ucla.edu.'}, {'ForeName': 'Donald P', 'Initials': 'DP', 'LastName': 'Tashkin', 'Affiliation': 'Department of Medicine, University of California, Los Angeles, David Geffen School of Medicine, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Roth', 'Affiliation': 'Department of Medicine, University of California, Los Angeles, David Geffen School of Medicine, USA.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Medicine, University of California, Los Angeles, David Geffen School of Medicine, USA.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Charles', 'Affiliation': 'McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Mayes', 'Affiliation': 'McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, USA; Department of Biostatistics, University of California, Los Angeles, Fielding School of Public Health Los Angeles, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Goldin', 'Affiliation': 'Department of Radiology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, USA.'}, {'ForeName': 'Lila', 'Initials': 'L', 'LastName': 'Pourzand', 'Affiliation': 'Department of Radiology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, USA.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Clements', 'Affiliation': 'Department of Medicine, University of California, Los Angeles, David Geffen School of Medicine, USA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Furst', 'Affiliation': 'Department of Medicine, University of California, Los Angeles, David Geffen School of Medicine, USA; Department of Medicine, University of Washington, Seattle, USA; Department of Rheumatology, University of Florence, Florence, Italy.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Khanna', 'Affiliation': 'Department of Medicine, University of Michigan Medical School, Ann Arbor, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Elashoff', 'Affiliation': 'Department of Biomathematics, University of California, Los Angeles, USA.'}, {'ForeName': 'Shervin', 'Initials': 'S', 'LastName': 'Assassi', 'Affiliation': 'McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, TX, USA.'}]",Seminars in arthritis and rheumatism,['10.1016/j.semarthrit.2020.06.003'] 1335,32918332,Effect of connective tissue grafting on buccal bone changes based on cone beam computed tomography scans in the esthetic zone of single immediate implants: A 1-year randomized controlled trial.,"BACKGROUND Connective tissue grafting has a beneficial effect on the peri-implant mucosa, but the effect of grafting the buccal mucosa on buccal bone thickness (BBT) has not been investigated, although BBT is proposed to be a key factor for the soft-tissue contour. The aim of this trial was to assess the outcome of a connective tissue graft (CTG) in the esthetic zone of single immediate implants on the change of BBT according to cone beam computed tomography (CBCT) scan analysis. METHODS In a 1-year randomized controlled trial, 60 patients received an immediately placed implant and provisionalization, either combined with CTG (test group) or without CTG (control group). CBCTs were taken preoperatively (T pre ) and 1 year after definitive restoration (T 2 ). Any change in BBT was assessed at different implant levels. Additionally, the change in mid-buccal mucosal level (MBML) and approximal marginal bone level were assessed. RESULTS Fifty-five patients were available for statistical analysis (test group, n = 28; control group, n = 27). At T 2 , the average change in BBT was significantly larger in the test group (-0.84 ± 0.61 mm) than in the control group (-0.46 ± 0.54 mm, P = 0.02). A MBML gain of 0.07 ± 0.85 mm in the test and a MBML loss -0.52 ± 1.16 mm in the control group was observed at T 2 . Average loss of marginal bone was 0.05 ± 0.33 mm and 0.01 ± 0.38 mm, respectively. CONCLUSIONS The application of CTG in the esthetic zone of immediately placed and provisionalized implants is accompanied with more loss of BBT, but at the same time better maintains the mid-buccal mucosal level.",2021,"Average loss of marginal bone was 0.05 ± 0.33 mm and 0.01 ± 0.38 mm, respectively. ","['60 patients received an', 'aesthetic zone of single immediate implants']","['immediately placed implant and provisionalization, either combined with CTG (test group) or without CTG (control group', 'connective tissue graft (CTG', 'CTG', 'connective tissue grafting']","['change in mid-buccal mucosal level (MBML) and approximal marginal bone level', 'Average loss of marginal bone', 'average change in BBT', 'BBT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",60.0,0.180517,"Average loss of marginal bone was 0.05 ± 0.33 mm and 0.01 ± 0.38 mm, respectively. ","[{'ForeName': 'Elise G', 'Initials': 'EG', 'LastName': 'Zuiderveld', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Wouter G', 'Initials': 'WG', 'LastName': 'van Nimwegen', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Henny J A', 'Initials': 'HJA', 'LastName': 'Meijer', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Ronald E', 'Initials': 'RE', 'LastName': 'Jung', 'Affiliation': 'Clinic of Fixed and Removable Prosthodontics and Dental Material Science, Center of Dental Medicine, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Mühlemann', 'Affiliation': 'Clinic of Fixed and Removable Prosthodontics and Dental Material Science, Center of Dental Medicine, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Arjan', 'Initials': 'A', 'LastName': 'Vissink', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Gerry M', 'Initials': 'GM', 'LastName': 'Raghoebar', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}]",Journal of periodontology,['10.1002/JPER.20-0217'] 1336,32917440,Ultrasound Guidance Versus Landmark-Guided Palpation for Radial Arterial Line Placement by Novice Emergency Medicine Interns: A Randomized Controlled Trial.,"BACKGROUND More than 10 million arterial lines are placed annually worldwide, many of which happen in the emergency department. Before the introduction of point-of-care ultrasound, landmark-guided palpation (LMGP) was considered standard of care. OBJECTIVE The objective of this study is to compare ultrasound-guided (USG) and LMGP of radial arterial line cannulation by novice emergency medicine interns. METHODS This was a single-center, prospective, randomized controlled trial (NCT03326739) of a convenience sample of adult patients who presented to an urban, university hospital with 100,000 visits annually. There was no funding for this study. Patients who required an arterial line were blindly randomized into LMGP or USG groups. Only novice emergency medicine interns, defined as interns with <15 previous placements, who were not blinded, performed the cannulation. Statistical analyses included t and Fisher exact tests. RESULTS Forty patients were enrolled with 20 patients randomized to each group. USG had a first-pass success of 75% vs. 0% for LMGP (p < 0.00001) and an overall success of 100% vs. 15% for LMGP (p < 0.00001), a mean of 1.30 attempts vs. 2.95 attempts for LMGP (a difference of 1.65; p < 0.0001), and a mean time for placement of 264 s vs. 524 s for LMGP (a difference of 260; p = 0.0025). Of the failed LMGP, USG crossover was 100% successful with a mean of 1.37 attempts (95% confidence interval 0.58-2.16) and 180 s for placement (95% confidence interval 97.92-262.08). Five percent of LMGP had a complication vs. 0% for USG (p = 1.0). CONCLUSIONS USG improved first-pass and overall success of radial arterial line cannulation while reducing time to access and attempts when used by novice emergency medicine interns.",2020,"CONCLUSIONS USG improved first-pass and overall success of radial arterial line cannulation while reducing time to access and attempts when used by novice emergency medicine interns.","['Forty patients were enrolled with 20 patients randomized to each group', 'Interns', 'Patients who required an arterial line', 'adult patients who presented to an urban, university hospital with 100,000 visits annually']","['ultrasound-guided (USG) and LMGP of radial arterial line cannulation', 'LMGP or USG', 'Ultrasound Guidance Versus Landmark-Guided Palpation for Radial Arterial Line Placement by Novice Emergency Medicine', 'LMGP']",['overall success'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003835', 'cui_str': 'Arterial line'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0332181', 'cui_str': 'Annual'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0003835', 'cui_str': 'Arterial line'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0013964', 'cui_str': 'Emergency medicine'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}]",40.0,0.349153,"CONCLUSIONS USG improved first-pass and overall success of radial arterial line cannulation while reducing time to access and attempts when used by novice emergency medicine interns.","[{'ForeName': 'Ryan C', 'Initials': 'RC', 'LastName': 'Gibbons', 'Affiliation': 'Department of Emergency Medicine, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Zanaboni', 'Affiliation': 'Department of Emergency Medicine, Einstein Medical Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Schae M', 'Initials': 'SM', 'LastName': 'Saravitz', 'Affiliation': 'Department of Emergency Medicine, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Costantino', 'Affiliation': 'Department of Emergency Medicine, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania.'}]",The Journal of emergency medicine,['10.1016/j.jemermed.2020.07.029'] 1337,32920241,"Sustaining the reach of a scalable weight loss intervention through financial incentives- a pragmatic, feasibility, online randomized trial protocol.","BACKGROUND High attrition following initial enrollment in evidence-based weight loss programs is a common, challenging, and under-studied issue. A behavioral economics approach consisting of modest monetary incentives may help to engage participants beyond enrollment to close the initial attrition gap. PURPOSE To describe the methods and design of a pragmatic, online randomized controlled trial (RCT) of an incentivized, technology-facilitated weight loss program through an innovative research-practice partnership involving primary care, health promotion researchers, and a small business. METHODS This study is a four-arm (1:1:1:1) RCT that compares the efficacy of outcome-based (weight loss), process-based (weighing in), a combination of outcome- and process-based, or choice-based incentives on sustaining program reach after initial enrollment for an evidence-based weight loss program. The multicomponent weight loss program includes a website, social cognitive theory-based daily health coaching, tailored messaging delivered via email and text messaging, access to online health coaches, and objective weight assessment through a community kiosk. The study will enroll 400 individuals aged 19 and older who have a body mass index ≥25 kg/m 2 , and have reliable access to the Internet or a smart phone. Participants will be followed for 3, 6, 9, and 12 months to assess program reach and representativeness, and continued participation after enrollment. The secondary outcomes include weight loss and program implementation costs. We will conduct participant focus groups to understand the barriers and facilitators of participation and key informant interviews focusing on clinic managers and care providers to explore the potential for future adoption and implementation of the evidence-based program. DISCUSSION This study possesses the potential to close the attrition gap after initial enrollment in a web-based digital weight loss intervention in the primary care and community settings. Clinicaltrials.gov registration: NCT04225234.",2020,This study possesses the potential to close the attrition gap after initial enrollment in a web-based digital weight loss intervention in the primary care and community settings.,"['400 individuals aged 19 and older who have a body mass index ≥25\u202fkg/m 2 , and have reliable access to the Internet or a smart phone']",['RCT'],['weight loss and program implementation costs'],"[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",400.0,0.110561,This study possesses the potential to close the attrition gap after initial enrollment in a web-based digital weight loss intervention in the primary care and community settings.,"[{'ForeName': 'Tzeyu L', 'Initials': 'TL', 'LastName': 'Michaud', 'Affiliation': 'Center for Reducing Health Disparities, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA; Department of Health Promotion, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA. Electronic address: tzeyu.michaud@unmc.edu.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Estabrooks', 'Affiliation': 'Center for Reducing Health Disparities, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA; Department of Health Promotion, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'You', 'Affiliation': 'Department of Public Health Sciences, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Todd J', 'Initials': 'TJ', 'LastName': 'McGuire', 'Affiliation': 'incentaHEALTH, LLC, Denver, CO, USA.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Almeida', 'Affiliation': 'Center for Reducing Health Disparities, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA; Department of Health Promotion, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Karls', 'Affiliation': 'Fontenelle clinic, Nebraska Medicine, Omaha, Nebraska, NE, USA.'}, {'ForeName': 'Kenya', 'Initials': 'K', 'LastName': 'Love', 'Affiliation': 'Center for Reducing Health Disparities, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Keyonna', 'Initials': 'K', 'LastName': 'King', 'Affiliation': 'Center for Reducing Health Disparities, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA; Department of Health Promotion, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Hill', 'Affiliation': 'Department of Epidemiology, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Reed', 'Affiliation': 'College of Nursing, Kearney Division, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Gwenndolyn', 'Initials': 'G', 'LastName': 'Porter', 'Affiliation': 'Department of Health Promotion, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Dejun', 'Initials': 'D', 'LastName': 'Su', 'Affiliation': 'Center for Reducing Health Disparities, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA; Department of Health Promotion, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106142'] 1338,32903062,Evaluation of green light exposure on headache frequency and quality of life in migraine patients: A preliminary one-way cross-over clinical trial.,"BACKGROUND Pharmacological management of migraine can be ineffective for some patients. We previously demonstrated that exposure to green light resulted in antinociception and reversal of thermal and mechanical hypersensitivity in rodent pain models. Given the safety of green light emitting diodes, we evaluated green light as a potential therapy in patients with episodic or chronic migraine. MATERIAL AND METHODS We recruited (29 total) patients, of whom seven had episodic migraine and 22 had chronic migraine. We used a one-way cross-over design consisting of exposure for 1-2 hours daily to white light emitting diodes for 10 weeks, followed by a 2-week washout period followed by exposure for 1-2 hours daily to green light emitting diodes for 10 weeks. Patients were allowed to continue current therapies and to initiate new treatments as directed by their physicians. Outcomes consisted of patient-reported surveys. The primary outcome measure was the number of headache days per month. Secondary outcome measures included patient-reported changes in the intensity and frequency of the headaches over a two-week period and other quality of life measures including ability to fall and stay asleep, and ability to perform work. Changes in pain medications were obtained to assess potential reduction. RESULTS When seven episodic migraine and 22 chronic migraine patients were analyzed as separate cohorts, white light emitting diodes produced no significant change in headache days in either episodic migraine or chronic migraine patients. Combining data from the episodic migraine and chronic migraine groups showed that white light emitting diodes produced a small, but statistically significant reduction in headache days from (days ± SEM) 18.2 ± 1.8 to 16.5 ± 2.01 days. Green light emitting diodes resulted in a significant decrease in headache days from 7.9 ± 1.6 to 2.4 ± 1.1 and from 22.3 ± 1.2 to 9.4 ± 1.6 in episodic migraine and chronic migraine patients, respectively. While some improvement in secondary outcomes was observed with white light emitting diodes, more secondary outcomes with significantly greater magnitude including assessments of quality of life, Short-Form McGill Pain Questionnaire, Headache Impact Test-6, and Five-level version of the EuroQol five-dimensional survey without reported side effects were observed with green light emitting diodes. Conclusions regarding pain medications reduction with green light emitting diode exposure were not possible. No side effects of light therapy were reported. None of the patients in the study reported initiation of new therapies. DISCUSSION Green light emitting diodes significantly reduced the number of headache days in people with episodic migraine or chronic migraine. Additionally, green light emitting diodes significantly improved multiple secondary outcome measures including quality of life and intensity and duration of the headache attacks. As no adverse events were reported, green light emitting diodes may provide a treatment option for those patients who prefer non-pharmacological therapies or may be considered in complementing other treatment strategies. Limitations of this study are the small number of patients evaluated. The positive data obtained support implementation of larger clinical trials to determine possible effects of green light emitting diode therapy.This study is registered with clinicaltrials.gov under NCT03677206.",2021,"Additionally, green light emitting diodes significantly improved multiple secondary outcome measures including quality of life and intensity and duration of the headache attacks.","['We recruited (29 total) patients, of whom seven had episodic migraine and 22 had chronic migraine', 'people with episodic migraine or chronic migraine', 'migraine patients', '22 chronic migraine patients', 'patients with episodic or chronic migraine']","['green light exposure', 'green light emitting diode therapy']","['pain medications', 'quality of life and intensity and duration of the headache attacks', 'headache frequency and quality of life', 'headache days', 'number of headache days per month', 'number of headache days', 'patient-reported changes in the intensity and frequency of the headaches over a two-week period and other quality of life measures including ability to fall and stay asleep, and ability to perform work', 'quality of life, Short-Form McGill Pain Questionnaire, Headache Impact Test-6, and Five-level version']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]","[{'cui': 'C1306567', 'cui_str': 'Green light'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0162676', 'cui_str': 'Enzyme-multiplied immunoassay technique'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0556971', 'cui_str': 'days/month'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0424522', 'cui_str': 'Asleep'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0457972', 'cui_str': 'Short form McGill pain questionnaire'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2607870', 'cui_str': 'Version'}]",,0.0526809,"Additionally, green light emitting diodes significantly improved multiple secondary outcome measures including quality of life and intensity and duration of the headache attacks.","[{'ForeName': 'Laurent F', 'Initials': 'LF', 'LastName': 'Martin', 'Affiliation': 'Department of Anesthesiology, College of Medicine, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Amol M', 'Initials': 'AM', 'LastName': 'Patwardhan', 'Affiliation': 'Department of Anesthesiology, College of Medicine, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Sejal V', 'Initials': 'SV', 'LastName': 'Jain', 'Affiliation': 'Department of Neurology, College of Medicine, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Salloum', 'Affiliation': 'Department of Anesthesiology, College of Medicine, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Freeman', 'Affiliation': 'Department of Anesthesiology, College of Medicine, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Khanna', 'Affiliation': 'Department of Anesthesiology, College of Medicine, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Gannala', 'Affiliation': 'Department of Anesthesiology, College of Medicine, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Vasudha', 'Initials': 'V', 'LastName': 'Goel', 'Affiliation': 'Department of Anesthesiology, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Felesia N', 'Initials': 'FN', 'LastName': 'Jones-MacFarland', 'Affiliation': 'Department of Neurology, College of Medicine, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'William Ds', 'Initials': 'WD', 'LastName': 'Killgore', 'Affiliation': 'Department of Psychiatry, College of Medicine, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Porreca', 'Affiliation': 'Department of Anesthesiology, College of Medicine, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Mohab M', 'Initials': 'MM', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Anesthesiology, College of Medicine, University of Arizona, Tucson, AZ, USA.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102420956711'] 1339,32919098,Evaluation of a personally-tailored opioid overdose prevention education and naloxone distribution intervention to promote harm reduction and treatment readiness in individuals actively using illicit opioids.,"BACKGROUND Opioid overdose prevention education and naloxone distribution (OEND) programs include information on general risk factors, overdose recognition, and naloxone utilization. This study evaluated a personally-tailored OEND (PTOEND) intervention designed to promote harm reduction and treatment readiness for illicit opioid users by also including education about personal overdose-risk factors and medication for opioid use disorder (MOUD). METHOD A secondary analysis of a randomized controlled trial testing a Peer recovery support service (PRSS) intervention, relative to Control, in adult illicit opioid users reporting treatment for an overdose in the prior 6 months. PTOEND, a 30-minute computer-guided intervention, was administered by a research assistant at the randomization visit to all participants (N = 80). Participants completed a telephone visit 3 weeks post-randomization (n = 74) to assess changes in opioid overdose/MOUD knowledge and treatment readiness. Participants completed in-person visits at 3 (n = 66), 6 (n = 58), and 12 (n = 44) months post-randomization to assess illicit opioid use and naloxone utilization (all time points) and overdose-risk behaviors (12 months). We conducted pre-post analyses of the impact of PTOEND controlling for the PRSS effect. RESULTS PTOEND increased knowledge of overdose (79.8% to 81.5%, p < 0.05) and MOUD (66.9% to 75.0%, p < 0.01) and decreased perceived treatment barriers (2.1 to 1.9, p < 0.01); desire to quit all substances increased (7.2 to 7.8, p = 0.05). Self-reported opioid use was significantly decreased at each follow-up (all p < 0.01). Self-reported overdose-risk behaviors decreased significantly (6.2 to 2.4, p < 0.01). A majority of participants (65 %) reported naloxone utilization. CONCLUSIONS PTOEND may be effective for promoting harm reduction and treatment readiness.",2020,"RESULTS PTOEND increased knowledge of overdose (79.8% to 81.5%, p < 0.05) and MOUD (66.9% to 75.0%, p < 0.01) and decreased perceived treatment barriers (2.1 to 1.9, p < 0.01); desire to quit all substances increased (7.2 to 7.8, p = 0.05).","['adult illicit opioid users reporting treatment for an overdose in the prior 6 months', 'individuals actively using illicit opioids']","['naloxone distribution intervention', 'Peer recovery support service (PRSS) intervention']","['Self-reported overdose-risk behaviors', 'Self-reported opioid use', 'knowledge of overdose', 'illicit opioid use and naloxone utilization (all time points) and overdose-risk behaviors', 'desire to quit all substances', 'MOUD']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332266', 'cui_str': 'Illicit'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0332266', 'cui_str': 'Illicit'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]",80.0,0.027065,"RESULTS PTOEND increased knowledge of overdose (79.8% to 81.5%, p < 0.05) and MOUD (66.9% to 75.0%, p < 0.01) and decreased perceived treatment barriers (2.1 to 1.9, p < 0.01); desire to quit all substances increased (7.2 to 7.8, p = 0.05).","[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA. Electronic address: winhusen@carc.uc.edu.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wilder', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Lyons', 'Affiliation': 'Department of Emergency Medicine, University of Cincinnati College of Medicine 231, Albert Sabin Way, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Kropp', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108265'] 1340,32923686,Foot thermometry with mHeath-based supplementation to prevent diabetic foot ulcers: A randomized controlled trial.,"Background : Novel approaches to reduce diabetic foot ulcers (DFU) in low- and middle-income countries are needed. Our objective was to compare incidence of DFUs in the thermometry plus mobile health (mHealth) reminders (intervention) vs. thermometry-only (control). Methods : We conducted a randomized trial enrolling adults with type 2 diabetes mellitus at risk of foot ulcers (risk groups 2 or 3) but without foot ulcers at the time of recruitment, and allocating them to control (instruction to use a liquid crystal-based foot thermometer daily) or intervention (same instruction supplemented with text and voice messages with reminders to use the device and messages to promote foot care) groups, and followed for 18 months. The primary outcome was time to occurrence of DFU. A process evaluation was also conducted. Results : A total of 172 patients (63% women, mean age 61 years) were enrolled; 86 to each study group. More patients enrolled in the intervention arm had a history of previous DFU (66% vs. 48%). Follow-up for the primary endpoint was complete for 158 of 172 participants (92%). Adherence to ≥80% of daily temperature measurements was 87% (103 of 118) among the study participants who returned the logbook. DFU cumulative incidence was 24% (19 of 79) in the intervention arm and 11% (9 of 79) in the control arm. After adjusting for history of foot ulceration and study site, the hazard ratio (HR) for DFU was 1.44 (95% CI 0.65, 3.22). Conclusions : In our study, conducted in a low-income setting, the addition of mHealth to foot thermometry was not effective in reducing foot ulceration. Importantly, there was a higher rate of previous DFU in the intervention group, the adherence to thermometry was high, and the expected rates of DFU used in our sample size calculations were not met. Trial registration : ClinicalTrials.gov NCT02373592 (27/02/2015).",2020,DFU cumulative incidence was 24% (19 of 79) in the intervention arm and 11% (9 of 79) in the control arm.,"['enrolling adults with type 2 diabetes mellitus at risk of foot ulcers (risk groups 2 or 3) but without foot ulcers at the time of recruitment and allocating them to', 'diabetic foot ulcers', '172 patients (63% women, mean age 61 years) were enrolled; 86 to each study group']","['control (instruction to use a liquid crystal-based foot thermometer daily) or intervention (same instruction supplemented with text and voice messages with reminders to use the device and messages to promote foot care', 'mHeath-based supplementation', ' ']","['history of DFU', 'Hazard Ratio (HR) for DFU', 'DFU cumulative incidence', 'diabetic foot ulcers (DFUs) incidence', 'time to occurrence of DFU']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0085119', 'cui_str': 'Ulcer of foot'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0302603', 'cui_str': 'Liquid Crystals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0039818', 'cui_str': 'Thermometer'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0150240', 'cui_str': 'Foot care'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",172.0,0.219747,DFU cumulative incidence was 24% (19 of 79) in the intervention arm and 11% (9 of 79) in the control arm.,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Lazo-Porras', 'Affiliation': 'CRONICAS Centre of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Bernabe-Ortiz', 'Affiliation': 'CRONICAS Centre of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Taype-Rondan', 'Affiliation': 'CRONICAS Centre of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Gilman', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'German', 'Initials': 'G', 'LastName': 'Malaga', 'Affiliation': 'CRONICAS Centre of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Helard', 'Initials': 'H', 'LastName': 'Manrique', 'Affiliation': 'Endocrinology Service, Hospital Nacional Arzobispo Loayza, Lima, Peru.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Neyra', 'Affiliation': 'Endocrinology Service, Hospital Nacional Arzobispo Loayza, Lima, Peru.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Calderon', 'Affiliation': 'Endocrinology Service, Hospital Nacional Arzobispo Loayza, Lima, Peru.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Pinto', 'Affiliation': 'Endocrinology Service, Hospital Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Armstrong', 'Affiliation': 'Southwestern Academic Limb Salvage Alliance (SALSA), Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Montori', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'J Jaime', 'Initials': 'JJ', 'LastName': 'Miranda', 'Affiliation': 'CRONICAS Centre of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}]",Wellcome open research,['10.12688/wellcomeopenres.15531.2'] 1341,32920022,Subgroup analysis of the ASPirin in Reducing Events in the Elderly randomized clinical trial suggests aspirin did not improve outcomes in older adults with chronic kidney disease.,"The role of aspirin for primary prevention in older adults with chronic kidney disease (CKD) is unclear. Therefore, post hoc analysis of the randomized controlled trial ASPirin in Reducing Events in the Elderly (ASPREE) was undertaken comparing 100 mg of enteric-coated aspirin daily against matching placebo. Participants were community dwelling adults aged 70 years and older in Australia, 65 years and older in the United States, all free of a history of dementia or cardiovascular disease and of any disease expected to lead to death within five years. CKD was defined as present at baseline if either eGFR under 60mL/min/1.73m 2 or urine albumin to creatinine ratio 3 mg/mmol or more. In 4758 participants with and 13004 without CKD, the rates of a composite endpoint (dementia, persistent physical disability or death), major adverse cardiovascular events and clinically significant bleeding in the CKD participants were almost double those without CKD. Aspirin's effects as estimated by hazard ratios were generally similar between CKD and non-CKD groups for dementia, persistent physical disability or death, major adverse cardiovascular events and clinically significant bleeding. Thus, in our analysis aspirin did not improve outcomes in older people while increasing the risk of bleeding, with mostly consistent effects in participants with and without CKD.",2021,"Aspirin's effects as estimated by hazard ratios were generally similar between CKD and non-CKD groups for dementia, persistent physical disability or death; major adverse cardiovascular events and clinically significant bleeding.","['Participants were community dwelling adults aged 70 years and older in Australia, 65 years and older in the United States, all free of a history of dementia or cardiovascular disease and of any disease expected to lead to death within five years', 'older adults with chronic kidney disease', 'older adults with chronic kidney disease (CKD', '4758 participants with and 13004 without CKD']","['Aspirin', 'ASPirin', 'enteric-coated aspirin daily against matching placebo', 'aspirin']","['rates of a composite endpoint (dementia, persistent physical disability or death), major adverse cardiovascular events and clinically significant bleeding', 'risk of bleeding', 'physical disability or death; major adverse cardiovascular events', 'hazard ratios']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0455499', 'cui_str': 'H/O: dementia'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",4758.0,0.0866962,"Aspirin's effects as estimated by hazard ratios were generally similar between CKD and non-CKD groups for dementia, persistent physical disability or death; major adverse cardiovascular events and clinically significant bleeding.","[{'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Wetmore', 'Affiliation': 'Department of Medicine, Hennepin Healthcare Systems, Minneapolis, Minnesota, USA; Chronic Disease Research Group, Hennepin Healthcare Research Institute, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Woods', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Hugh', 'Initials': 'H', 'LastName': 'Gallagher', 'Affiliation': 'Renal Services, Epsom and St Helier University Hospitals NHS Trust, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Roderick', 'Affiliation': 'School of Primary Care, Population Sciences and Medical Education, University of Southampton and Southampton General Hospital, Hampshire, UK.'}, {'ForeName': 'Rowan', 'Initials': 'R', 'LastName': 'Walker', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia; School of Public Health, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Raj C', 'Initials': 'RC', 'LastName': 'Shah', 'Affiliation': ""Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago, Illinois, USA.""}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Ernst', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Lockery', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Tonkin', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Walter P', 'Initials': 'WP', 'LastName': 'Abhayaratna', 'Affiliation': 'College of Medicine, Biology and Environment, Australian National University, Canberra, Australian Capital Territory, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gibbs', 'Affiliation': 'Walter and Eliza Hall Institute of Medical Research, Melbourne, Victoria, Australia.'}, {'ForeName': 'Erica M', 'Initials': 'EM', 'LastName': 'Wood', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Mahady', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia; Department of Gastroenterology, Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jeff D', 'Initials': 'JD', 'LastName': 'Williamson', 'Affiliation': ""Sticht Center on Healthy Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.""}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Donnan', 'Affiliation': 'Melbourne Brain Centre, Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Geoffrey C', 'Initials': 'GC', 'LastName': 'Cloud', 'Affiliation': 'Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Murray', 'Affiliation': 'Department of Medicine, Hennepin Healthcare Systems, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Kevan R', 'Initials': 'KR', 'LastName': 'Polkinghorne', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia; Department of Nephrology, Monash Medical Centre, Monash Health, Melbourne, Victoria, Australia. Electronic address: kevan.polkinghorne@monash.edu.'}]",Kidney international,['10.1016/j.kint.2020.08.011'] 1342,32918131,"Results of the non-small cell lung cancer part of a phase III, open-label, randomized trial evaluating topical corticosteroid therapy for facial acneiform dermatitis induced by EGFR inhibitors: stepwise rank down from potent corticosteroid (FAEISS study, NCCH-1512).","PURPOSE This FAEISS study was designed to confirm the superior efficacy of reactive topical corticosteroid strategies employing serially ranking-DOWN from very strong steroid levels for the treatment of facial acneiform rash induced by epidermal growth factor receptor (EGFR) inhibitors (EGFRIs), in comparison with strategies employing serially ranking-UP from weak steroid levels. This article reports the primary results of the non-small cell lung cancer (NSCLC) part of the trial. METHODS Patients with EGFR-mutated advanced NSCLC treated with erlotinib or afatinib were enrolled in the first registration. All patients received preemptive therapy with oral minocycline and heparinoid moisturizer from the initiation of an EGFR inhibitor. Enrolled patients who developed facial acneiform rash within 2 weeks were randomized at second registration to either a ranking-UP (WEAK) group or a ranking-DOWN group. The primary endpoint was incidence of grade ≥ 2 facial acneiform rash over 8 weeks. RESULTS Fifty-one patients were enrolled at the first registration and received EGFRIs (n = 30 for afatinib, n = 21 for erlotinib). However, 35 patients did not develop facial acneiform rash within 2 weeks; one patient discontinued preemptive treatment. Fifteen patients (29.4%) were enrolled in the second registration; nine were assigned to the WEAK group and six to the DOWN group. There was no significant difference in the incidence of grade ≥ 2 facial acneiform rash between the WEAK group (one patient, twice) and the DOWN group (one patient, twice; p = 0.8417). No patients developed severe facial acneiform rash within 10 weeks. CONCLUSION In NSCLC patients who received EGFRIs, preemptive therapy of oral minocycline and heparinoid moisturizer reduced facial acneiform rash incidence. TRIAL REGISTRATION UMIN000024113.",2021,"There was no significant difference in the incidence of grade ≥ 2 facial acneiform rash between the WEAK group (one patient, twice) and the DOWN group (one patient, twice; p = 0.8417).","['Patients with EGFR-mutated advanced NSCLC treated with erlotinib or afatinib were enrolled in the first registration', 'Fifty-one patients were enrolled at the first registration and received', 'Enrolled patients who developed facial acneiform rash within 2 weeks', 'Fifteen patients (29.4%) were enrolled in the second registration; nine']","['EGFRIs', 'ranking-UP (WEAK) group or a ranking-DOWN group', 'preemptive therapy with oral minocycline and heparinoid moisturizer from the initiation of an EGFR inhibitor', 'minocycline', 'topical corticosteroid therapy']","['severe facial acneiform rash', 'incidence of grade ≥ 2 facial acneiform rash', 'facial acneiform rash incidence', 'facial acneiform rash', 'incidence of grade ≥', '2 facial acneiform rash']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C2987648', 'cui_str': 'Afatinib'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205436', 'cui_str': 'Second'}]","[{'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C0019142', 'cui_str': 'Heparinoids'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C1443775', 'cui_str': 'Epidermal growth factor receptor antagonist-containing product'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",51.0,0.0654059,"There was no significant difference in the incidence of grade ≥ 2 facial acneiform rash between the WEAK group (one patient, twice) and the DOWN group (one patient, twice; p = 0.8417).","[{'ForeName': 'Kazumi', 'Initials': 'K', 'LastName': 'Nishino', 'Affiliation': 'Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka, Japan. kazumi.nishino@oici.jp.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Ohe', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Saito', 'Affiliation': 'Department of Respiratory Medicine, Tohoku University Hospital, Miyagi, Japan.'}, {'ForeName': 'Eisaku', 'Initials': 'E', 'LastName': 'Miyauchi', 'Affiliation': 'Department of Respiratory Medicine, Tohoku University Hospital, Miyagi, Japan.'}, {'ForeName': 'Tetsu', 'Initials': 'T', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Mie University Graduate School of Medicine, Mie, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Nakai', 'Affiliation': 'Department of Dermatology, Mie University Graduate School of Medicine, Mie, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Shibata', 'Affiliation': 'Biostatistics Division, Center for Research Administration and Support, National Cancer Center, Tokyo, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Hamaguchi', 'Affiliation': 'Department of Gastroenterological Oncology, Saitama Medical University International Medical Center, Saitama, Japan.'}, {'ForeName': 'Katsuko', 'Initials': 'K', 'LastName': 'Kikuchi', 'Affiliation': 'Department of Dermatology, Tohoku University Graduate School of Medicine, Miyagi, Japan.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Yamazaki', 'Affiliation': 'Department of Dermatological Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Fukuda', 'Affiliation': 'Data Management Division, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Nozawa', 'Affiliation': 'Appearance Support Center, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Kiyohara', 'Affiliation': 'Department of Dermatology, Shizuoka Cancer Center, Shizuoka, Japan.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05765-7'] 1343,32929855,Early and maintained application of the secretion of Cryptomphalus aspersa (SCA) 40% improves cutaneous healing after ablative fractional laser in skin aging.,"BACKGROUND Ablative fractional laser generates a regulated skin damage, which secondarily improves skin aging. AIMS The main objective of the present study was to figure out if the adverse effects induced by laser and the skin recovery could improve with the application of a cosmetic product based on the secretion of Cryptomphalus aspersa (SCA). PATIENTS/METHODS A prospective double-blind controlled study with vehicle in 10 patients with skin aging. The patients received one session of fractional ablative CO 2  laser, and the formulation with SCA 40% was applied immediately and maintained throughout the 21-day duration of the study. The active treatment (SCA) was applied to one hemifacial area and vehicle to the other, and the patient acting was her own control. Clinical evaluations, dermoscopy, photography, and other parameters like cutaneous hydration, elasticity, and wrinkles were evaluated. In addition, the severity of the adverse effects was evaluated. RESULTS Significant greater decrease in the density of microcolumns produced by laser was detected on the active-treated side, indicating greater and faster postprocedure recovery compared to the vehicle-treated side. In addition, side effects were reduced and some antiaging effects were more apparent on the side treated with SCA 40%. CONCLUSION SCA 40% applied immediately after ablative laser, and during the next days, it can accelerate laser-induced damage regeneration. In addition, SCA improves the cosmetic outcome after laser application.",2021,"RESULTS Significant greater decrease in the density of microcolumns produced by laser were detected on the active-treated side, indicating greater and faster post-procedure recovery compared to the vehicle-treated side.",['10 patients with skin aging'],"['SCA', 'fractional ablative CO 2 laser and the formulation with SCA']","['cutaneous healing', 'side effects', 'severity of the adverse effects', 'density of microcolumns', 'cosmetic outcome']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]","[{'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",10.0,0.0245539,"RESULTS Significant greater decrease in the density of microcolumns produced by laser were detected on the active-treated side, indicating greater and faster post-procedure recovery compared to the vehicle-treated side.","[{'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Fernandez-Gonzalez', 'Affiliation': 'Hospital Central de la Defensa, Madrid, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vitale', 'Affiliation': 'Medical Department of Cantabria labs at Madrid, Madrid, Spain.'}, {'ForeName': 'M Teresa', 'Initials': 'MT', 'LastName': 'Truchuelo', 'Affiliation': 'Vithas Nuestra Señora de América Hospital, Madrid, Spain.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13720'] 1344,32924207,Computer-delivered brief alcohol intervention for patients with liver disease: a randomized controlled trial.,"BACKGROUND AND AIMS Reducing alcohol consumption by liver disease patients can reduce morbidity and mortality. This study compared a computer-delivered brief alcohol intervention (cBAI) with standard care in a sample of US military veterans with liver disease. DESIGN Multi-site, randomized controlled trial of a cBAI plus standard care (n = 67) versus standard care only (n = 71). Participants were assessed at baseline and 3- and 6-month follow-up. SETTING US Veterans Health Administration liver clinics. PARTICIPANTS Participants were mostly male and diagnosed with hepatitis C. INTERVENTIONS AND COMPARATORS A cBAI tailored to veterans with liver disease and consisting of assessment and personalized feedback. Standard care was brief education and advice about alcohol and liver disease. MEASUREMENT Primary outcomes were self-reported number of drinking days and unhealthy drinking days (defined as more than two drinks for men and more than one for women) in the past 30 days at 6-month follow-up. Secondary outcomes were these two variables at 3-month follow-up, and drinks consumed per drinking day, depression and overall health at 3- and 6-month follow-ups. Missing data were imputed using multiple imputation. FINDINGS Compared with standard care, cBAI participants reported significantly fewer drinking days at 6-month follow-up and fewer unhealthy drinking days at both 3- and 6-month follow-ups. Least square means (LS-means) for number of drinking days were 3.78 for the cBAI condition and 6.89 for the standard care condition at 6 months [LS-mean ratio = 3.78/6.89 = 0.55, 95% confidence interval (CI) = 0.34, 0.89]. LS-means for number of unhealthy drinking days were 1.04 for the cBAI condition and 2.57 for the standard care condition at 3-month follow-up (LS-mean ratio = 1.04/2.57 = 0.41, 95% CI = 0.19, 0.85). At 6-months follow-up, LS-means were 1.18 for the cBAI condition and 2.75 for the standard care condition (LS-mean ratio = 1.18/2.75 = 0.43, 95% CI = 0.20, 0.91). CONCLUSIONS A computer-delivered brief alcohol intervention reduced drinking days and unhealthy drinking days at 6-month follow up in military veterans with liver disease compared with brief education and advice to reduce consumption.",2021,"CONCLUSIONS A computer-delivered brief alcohol intervention reduced drinking days and unhealthy drinking days at 6-month follow up in military veterans with liver disease compared with brief education and advice to reduce consumption.","['Participants were mostly male and diagnosed with hepatitis C', 'liver disease patients', 'n=71', 'Patients with Liver Disease', 'military veterans with liver disease', 'US Veterans Health Administration liver clinics']","['Computer-Delivered Brief Alcohol Intervention', 'cBAI plus standard care (n=67) versus standard care only', 'computer-delivered brief alcohol intervention (cBAI) with standard care']","['morbidity and mortality', '3-month follow-up, and drinks consumed per drinking day, depression, and overall health', 'self-reported number of drinking days and unhealthy drinking days (defined as >2 drinks for men and >1 for women']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0178672', 'cui_str': 'Health administration'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",,0.062993,"CONCLUSIONS A computer-delivered brief alcohol intervention reduced drinking days and unhealthy drinking days at 6-month follow up in military veterans with liver disease compared with brief education and advice to reduce consumption.","[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Cucciare', 'Affiliation': 'Center for Mental Healthcare and Outcomes Research, Central Arkansas Veterans Affairs Healthcare System, North Little Rock, AR, USA.'}, {'ForeName': 'Ann S', 'Initials': 'AS', 'LastName': 'Combs', 'Affiliation': 'Center for Innovation to Implementation, Veterans Affairs Palo Alto Health Care System, Menlo Park, CA, USA.'}, {'ForeName': 'Gauri', 'Initials': 'G', 'LastName': 'Joshi', 'Affiliation': 'Center for Innovation to Implementation, Veterans Affairs Palo Alto Health Care System, Menlo Park, CA, USA.'}, {'ForeName': 'Xiaotong', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Center for Mental Healthcare and Outcomes Research, Central Arkansas Veterans Affairs Healthcare System, North Little Rock, AR, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Humphreys', 'Affiliation': 'Center for Innovation to Implementation, Veterans Affairs Palo Alto Health Care System, Menlo Park, CA, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15263'] 1345,32924586,Transcranial Direct Current Stimulation Combined With Cognitive Training Induces Response Inhibition Facilitation Through Distinct Neural Responses According to the Stimulation Site: A Follow-up Event-Related Potentials Study.,"OBJECTIVE We investigated whether the mid-term impact (1 week posttraining) of a ""combined cognitive rehabilitation (CRP)/transcranial direct current stimulation (tDCS) program"" on the performance of a Go/No-go task was enhanced compared with isolated CRP and whether it varied according to the stimulation site (right inferior frontal gyrus [rIFG] vs right dorsolateral prefrontal cortex [rDLPFC]). METHODS A total of 150 healthy participants were assigned to (1) an Inhibition Training (IT) group, (2) a group receiving active tDCS over the rIFG in combination with IT (IT + IF), (3) a group receiving active tDCS over the rDLPFC in combination with IT (IT + DL), (4) a group receiving IT with sham tDCS (ITsham), and (5) a No-Training (NT) group to control for test-retest effects. Each group undertook 3 sessions of a Go/No-go task concomitant with the recording of event-related potentials (T0, before training; T1, at the end of a 4-day training session [20 minutes each day]; T2, 1 week after T1). RESULTS With the exception of the NT participants, all the groups exhibited improved performances at T2. The IT + DL group exhibited the best improvement profile, indexed by faster response times (RTs) (T0 > T1 = T2), with a reduced rate of errors at the posttraining sessions compared with both T0 and T1. This ""inhibitory learning effect"" was neurophysiologically indexed by shorter No-go N2d latencies and enhanced No-go P3d amplitudes. CONCLUSION CRP combined with active tDCS over the rDLPFC appears to be optimal for boosting long-term (one week) inhibitory skills as it induced specific and robust neural changes.",2021,"No-go task was enhanced compared with isolated CRP and whether it varied according to the stimulation site (right inferior frontal gyrus [rIFG] vs right dorsolateral prefrontal cortex [rDLPFC]). ",['150 healthy participants'],"['combined cognitive rehabilitation (CRP)/transcranial direct current stimulation (tDCS) program', 'Transcranial Direct Current Stimulation Combined With Cognitive Training', 'Inhibition Training (IT) group, (2) a group receiving active tDCS over the rIFG in combination with IT (IT + IF), (3) a group receiving active tDCS over the rDLPFC in combination with IT (IT + DL), (4) a group receiving IT with sham tDCS (ITsham), and (5) a No-Training (NT', 'CRP combined with active tDCS']","['rate of errors', 'faster response times (RTs']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",150.0,0.0257827,"No-go task was enhanced compared with isolated CRP and whether it varied according to the stimulation site (right inferior frontal gyrus [rIFG] vs right dorsolateral prefrontal cortex [rDLPFC]). ","[{'ForeName': 'Clémence', 'Initials': 'C', 'LastName': 'Dousset', 'Affiliation': ""Laboratoire de Psychologie Médicale et d'Addictologie, 26659ULB Neuroscience Institute (UNI), CHU Brugmann-Université Libre de Bruxelles (U.L.B.), Belgium.""}, {'ForeName': 'Anaïs', 'Initials': 'A', 'LastName': 'Ingels', 'Affiliation': ""Laboratoire de Psychologie Médicale et d'Addictologie, 26659ULB Neuroscience Institute (UNI), CHU Brugmann-Université Libre de Bruxelles (U.L.B.), Belgium.""}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Schröder', 'Affiliation': ""Laboratoire de Psychologie Médicale et d'Addictologie, 26659ULB Neuroscience Institute (UNI), CHU Brugmann-Université Libre de Bruxelles (U.L.B.), Belgium.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Angioletti', 'Affiliation': 'Research Unit in Affective and Social Neuroscience, 9371Catholic University of the Sacred Heart, Milan, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Balconi', 'Affiliation': 'Research Unit in Affective and Social Neuroscience, 9371Catholic University of the Sacred Heart, Milan, Italy.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Kornreich', 'Affiliation': ""Laboratoire de Psychologie Médicale et d'Addictologie, 26659ULB Neuroscience Institute (UNI), CHU Brugmann-Université Libre de Bruxelles (U.L.B.), Belgium.""}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Campanella', 'Affiliation': ""Laboratoire de Psychologie Médicale et d'Addictologie, 26659ULB Neuroscience Institute (UNI), CHU Brugmann-Université Libre de Bruxelles (U.L.B.), Belgium.""}]",Clinical EEG and neuroscience,['10.1177/1550059420958967'] 1346,32921196,Attainment of Targets of the 20-Year Infancy-Onset Dietary Intervention and Blood Pressure Across Childhood and Young Adulthood: The Special Turku Coronary Risk Factor Intervention Project (STRIP).,"We examined whether success in achieving the key targets of an infancy-onset 20-year dietary intervention was associated with blood pressure (BP) from infancy to young adulthood. In the prospective randomized STRIP (Special Turku Coronary Risk Factor Intervention Project; n=877 children), dietary counseling was provided biannually based on the Nordic Nutrition Recommendations primarily to improve the quality of dietary fat in children's diets and secondarily to promote intake of vegetables, fruits, and whole grains. Dietary data and BP were accrued annually from the age of 13 months to 20 years. The dietary targets for fat quality were defined as the ratio of saturated fatty acids to monounsaturated and polyunsaturated fatty acids <1:2 and intake of saturated fatty acids <10 E%, dietary fiber intake in the top age-specific quintile, and dietary sucrose intake as being in the lowest age-specific quintile. Attaining a higher number of the dietary targets was associated with lower systolic BP (mean [SE] systolic BP, 107.3 [0.3], 107.6 [0.3], 106.8 [0.3], and 106.7 [0.5] mm Hg in participants meeting 0, 1, 2, and 3 to 4 targets, respectively; P =0.03) and diastolic BP (mean [SE] diastolic BP, 60.4 [0.2], 60.5 [0.2], 59.9 [0.2], and 59.9 [0.3] mm Hg; P =0.02). When the lowest age-specific quintile of dietary cholesterol was added as an additional target, the association with systolic BP remained significant ( P =0.047), but the association with diastolic BP attenuated ( P =0.13). Achieving the key targets of an infancy-onset 20-year dietary intervention, reflecting dietary guidelines, was favorably albeit modestly associated with systolic and diastolic BP from infancy to young adulthood. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT00223600.",2020,"Attaining a higher number of the dietary targets was associated with lower systolic BP (mean [SE] systolic BP, 107.3 [0.3], 107.6 [0.3], 106.8 [0.3], and 106.7 [0.5] mm Hg in participants meeting 0, 1, 2, and 3 to 4 targets, respectively; P =0.03) and diastolic BP (mean [SE] diastolic BP, 60.4 [0.2], 60.5 [0.2], 59.9 [0.2], and 59.9 [0.3",['Across Childhood and Young Adulthood'],"['20-Year Infancy-Onset Dietary Intervention and Blood Pressure', ""dietary counseling was provided biannually based on the Nordic Nutrition Recommendations primarily to improve the quality of dietary fat in children's diets and secondarily to promote intake of vegetables, fruits, and whole grains""]","['systolic and diastolic BP', 'systolic BP', 'blood pressure (BP', 'Dietary data and BP', 'diastolic BP']","[{'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0700597', 'cui_str': 'Adulthood'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0585342', 'cui_str': 'Every other year'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0012171', 'cui_str': 'Dietary fat'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]",877.0,0.0185772,"Attaining a higher number of the dietary targets was associated with lower systolic BP (mean [SE] systolic BP, 107.3 [0.3], 107.6 [0.3], 106.8 [0.3], and 106.7 [0.5] mm Hg in participants meeting 0, 1, 2, and 3 to 4 targets, respectively; P =0.03) and diastolic BP (mean [SE] diastolic BP, 60.4 [0.2], 60.5 [0.2], 59.9 [0.2], and 59.9 [0.3","[{'ForeName': 'Tomi T', 'Initials': 'TT', 'LastName': 'Laitinen', 'Affiliation': 'From the Research Centre of Applied and Preventive Cardiovascular Medicine (T.T.L., J.N., S.P.R., C.G.M., O.T.R., K.P.), University of Turku, Finland.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Nuotio', 'Affiliation': 'From the Research Centre of Applied and Preventive Cardiovascular Medicine (T.T.L., J.N., S.P.R., C.G.M., O.T.R., K.P.), University of Turku, Finland.'}, {'ForeName': 'Harri', 'Initials': 'H', 'LastName': 'Niinikoski', 'Affiliation': 'Centre for Population Health Research (T.T.L., J.N., H.N., S.P.R., C.G.M., H.L., O.T.R., K.P.), Turku University Hospital, University of Turku, Finland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Juonala', 'Affiliation': 'Department of Medicine (M.J., J.S.A.V., T.R.), University of Turku, Finland.'}, {'ForeName': 'Suvi P', 'Initials': 'SP', 'LastName': 'Rovio', 'Affiliation': 'From the Research Centre of Applied and Preventive Cardiovascular Medicine (T.T.L., J.N., S.P.R., C.G.M., O.T.R., K.P.), University of Turku, Finland.'}, {'ForeName': 'Jorma S A', 'Initials': 'JSA', 'LastName': 'Viikari', 'Affiliation': 'Department of Medicine (M.J., J.S.A.V., T.R.), University of Turku, Finland.'}, {'ForeName': 'Tapani', 'Initials': 'T', 'LastName': 'Rönnemaa', 'Affiliation': 'Department of Medicine (M.J., J.S.A.V., T.R.), University of Turku, Finland.'}, {'ForeName': 'Costan G', 'Initials': 'CG', 'LastName': 'Magnussen', 'Affiliation': 'From the Research Centre of Applied and Preventive Cardiovascular Medicine (T.T.L., J.N., S.P.R., C.G.M., O.T.R., K.P.), University of Turku, Finland.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Sabin', 'Affiliation': ""Murdoch Children's Research Institute (T.T.L., J.N., M.S., D.B.), The Royal Children's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Burgner', 'Affiliation': ""Murdoch Children's Research Institute (T.T.L., J.N., M.S., D.B.), The Royal Children's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Eero', 'Initials': 'E', 'LastName': 'Jokinen', 'Affiliation': 'Department of Pediatric Cardiology, Hospital for Children and Adolescents, University of Helsinki, Finland (E.J.).'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Lagström', 'Affiliation': 'Centre for Population Health Research (T.T.L., J.N., H.N., S.P.R., C.G.M., H.L., O.T.R., K.P.), Turku University Hospital, University of Turku, Finland.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Jula', 'Affiliation': 'Department of Chronic Disease Prevention, Institute for Health and Welfare, Turku, Finland (A.J.).'}, {'ForeName': 'Olli', 'Initials': 'O', 'LastName': 'Simell', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine (H.N., O.S.), Turku University Hospital, University of Turku, Finland.'}, {'ForeName': 'Olli T', 'Initials': 'OT', 'LastName': 'Raitakari', 'Affiliation': 'From the Research Centre of Applied and Preventive Cardiovascular Medicine (T.T.L., J.N., S.P.R., C.G.M., O.T.R., K.P.), University of Turku, Finland.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Pahkala', 'Affiliation': 'From the Research Centre of Applied and Preventive Cardiovascular Medicine (T.T.L., J.N., S.P.R., C.G.M., O.T.R., K.P.), University of Turku, Finland.'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.15075'] 1347,32930088,Treatment of compulsive buying disorder: comparing the effectiveness of cognitive behavioural therapy with person-centred experiential counselling.,"BACKGROUND Outcome studies of the treatment of compulsive buying disorder (CBD) have rarely compared the effectiveness of differing active treatments. AIMS This study sought to compare the effectiveness of cognitive behavioural therapy (CBT) and person-centred experiential therapy (PCE) in a cross-over design. METHOD This was an ABC single case experimental design with extended follow-up with a female patient meeting diagnostic criteria for CBD. Ideographic CBD outcomes were intensively measured over a continuous 350-day time series. Following a 1-month baseline assessment phase (A; 28 days; three sessions), CBT was delivered via 13 out-patient sessions (B: 160 days) and then PCE was delivered via six out-patient sessions (C: 63 days). There was a 99-day follow-up period. RESULTS Frequency and duration of compulsive buying episodes decreased during active treatment. CBT and PCE were both highly effective compared with baseline for reducing shopping obsessions, excitement about shopping, compulsion to shop and improving self-esteem. When the PCE and CBT treatment phases were compared against each other, few differences were apparent in terms of outcome. There was no evidence of any relapse over the follow-up period. A reliable and clinically significant change on the primary nomothetic measure (i.e. Compulsive Buying Scale) was retained over time. CONCLUSIONS The study suggests that both CBT and PCE can be effective for CBD. Methodological limitations and suggestions for future CBD outcome research are discussed.",2021,"CBT and PCE were both highly effective compared with baseline for reducing shopping obsessions, excitement about shopping, compulsion to shop and improving self-esteem.","['compulsive buying disorder (CBD', 'compulsive buying disorder']","['CBT', 'PCE', 'cognitive behavioural therapy (CBT) and person-centred experiential therapy (PCE', 'CBT and PCE', 'cognitive behavioural therapy with person-centred experiential counselling']","['Frequency and duration of compulsive buying episodes', 'shopping obsessions, excitement about shopping, compulsion to shop and improving self-esteem', 'Ideographic CBD outcomes', 'primary nomothetic measure (i.e. Compulsive Buying Scale']","[{'cui': 'C0520949', 'cui_str': 'Compulsive buying'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0520949', 'cui_str': 'Compulsive buying'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0150768', 'cui_str': 'Shopping'}, {'cui': 'C0233697', 'cui_str': 'Obsessional thoughts'}, {'cui': 'C0233571', 'cui_str': 'Excitement'}, {'cui': 'C0600104', 'cui_str': 'Compulsive behavior'}, {'cui': 'C0041472', 'cui_str': 'Murine typhus'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0399357,"CBT and PCE were both highly effective compared with baseline for reducing shopping obsessions, excitement about shopping, compulsion to shop and improving self-esteem.","[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Kellett', 'Affiliation': 'University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Pippa', 'Initials': 'P', 'LastName': 'Oxborough', 'Affiliation': 'University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Gaskell', 'Affiliation': 'University of Sheffield, Sheffield, UK.'}]",Behavioural and cognitive psychotherapy,['10.1017/S1352465820000521'] 1348,32925495,A Low-Calorie Diet with or without Exercise Reduces Postprandial Aortic Waveform in Females with Obesity.,"PURPOSE Arterial stiffness is considered a predictor of cardiovascular disease. Females have higher values of arterial stiffness than males, suggesting a greater risk of heart-related complications. Although a low-calorie diet (LCD) reduces fasting arterial stiffness, in part through weight loss, it is unknown if interval exercise (INT) adds to the benefit of LCD on fasting and postprandial arterial stiffness in females with obesity. METHODS Twenty-five females (47 ± 2.6 yr, 37.6 ± 1.3 kg·m-2) were randomized to 13 d of LCD (n = 12; mixed meals of ~1200 kcal·d-1) or LCD + INT (n = 13; 60 min·d-1 of supervised 3-min intervals at 90% HRpeak and 50% HRpeak). Arterial stiffness (augmentation index [AIx] and carotid-femoral pulse wave velocity [cfPWV]) and blood biochemistries were measured during a 75-g oral glucose tolerance test before and after the intervention to determine fasting and postprandial arterial stiffness as well as insulin sensitivity (simple index of insulin sensitivity [SIIS]) and inflammation (C-reactive protein, interleukin 8, and tumor necrosis factor alpha). RESULTS Although LCD + INT increased V˙O2peak and HDL compared with LCD (P = 0.04 and P < 0.01, respectively), both interventions decreased body fat, LDL, total cholesterol, and triglycerides (all P < 0.01) and increased SIIS (P = 0.03). Despite no effect on fasting AIx (P = 0.27), LCD and LCD + INT decreased AIx60min (-7.4% ± 4.3% vs -7.0% ± 5.0%, P = 0.04) and tAUC120min (-663 ± 263 vs -457 ± 406, P = 0.03). There were no changes in fasting cfPWV (P = 0.91) or cfPWV120min (P = 0.62). Increased SIIS and decreased interleukin 8 were associated with reduced fasting AIx (r = -0.44, P = 0.03, and r = 0.40, P = 0.055), whereas decreased C-reactive protein correlated with reduced postprandial AIx60min (r = 0.43, P = 0.04). CONCLUSION Independent of exercise, 13 d of LCD reduces postprandial AIx in females with obesity. Insulin sensitivity and inflammation correlated with improved arterial stiffness, suggesting unique mechanisms regulate fasted versus postprandial arterial stiffness.",2021,"RESULTS While LCD+INT increased VO2peak and HDL compared to LCD (P=0.04 and P<0.01, respectively), both interventions decreased body fat, LDL, total cholesterol and triglycerides (all P<0.01) and increased SIIS (P=0.03).","['Females with Obesity', 'females with obesity', 'Twenty-five females (47±2.6 yrs; 37.6±1.3 kg·m']","['LCD+INT', 'LCD', 'Low-Calorie Diet with or without Exercise', 'low-calorie diet (LCD']","['body fat, LDL, total cholesterol and triglycerides (all P<0.01) and increased SIIS', 'CRP', 'VO2peak and HDL', 'fasting AIx', 'tAUC120min', 'Increased SIIS and decreased IL-8', 'Arterial stiffness (augmentation index (AIx) and carotid-femoral pulse wave velocity (cfPWV)) and blood biochemistries', 'reduced fasting AIx', 'arterial stiffness', 'Postprandial Aortic Waveform', 'insulin sensitivity (SIIS) and inflammation (CRP, IL-8, TNF-α', 'Insulin sensitivity and inflammation', 'LCD and LCD+INT decreased AIx60min', 'fasting cfPWV']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3715062', 'cui_str': '25'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}]","[{'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0999177', 'cui_str': 'Aix'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0450448', 'cui_str': 'Waveforms'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.026757,"RESULTS While LCD+INT increased VO2peak and HDL compared to LCD (P=0.04 and P<0.01, respectively), both interventions decreased body fat, LDL, total cholesterol and triglycerides (all P<0.01) and increased SIIS (P=0.03).","[{'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Heiston', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Gilbertson', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Natalie Z M', 'Initials': 'NZM', 'LastName': 'Eichner', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Malin', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002515'] 1349,32926410,Randomized clinical trial of negative pressure wound therapy as an adjunctive treatment for small-area thermal burns in children.,"BACKGROUND The efficacy of negative pressure wound therapy (NPWT) in the acute management of burns remains unclear. The purpose of this trial was to compare standard Acticoat™ and Mepitel™ dressings with combined Acticoat™, Mepitel™ and continuous NPWT to determine the effect of adjunctive NPWT on re-epithelialization in paediatric burns. METHODS This two-arm, single-centre RCT recruited children with acute thermal burns covering less than 5 per cent of their total body surface area. The primary outcome was time to re-epithelialization. Blinded assessments were performed using photographs captured every 3-5 days until discharge. Secondary measures included pain, itch, grafting, perfusion and scar management referrals. RESULTS Some 114 patients were randomized. Median time to re-epithelialization was 8 (i.q.r. 7-11) days in the NPWT group and 10 (8-14) days in the control group. In a multivariable model, NPWT decreased the expected time to wound closure by 22 (95 per cent c.i. 7 to 34) per cent (P = 0·005). The risk of referral to scar management was reduced by 60 (18 to 81) per cent (P = 0·013). Four participants in the control group and one in the NPWT group underwent grafting. There were no statistically significant differences between groups in pain, itch or laser Doppler measures of perfusion. Adverse events were rare and minor, although NPWT carried a moderate treatment burden, with ten patients discontinuing early. CONCLUSION Adjunctive NPWT hastened re-epithelialization in small-area burn injuries in children, but had a greater treatment burden than standard dressings alone. Registration number: ACTRN12618000256279 ( http://ANZCTR.org.au).",2020,"There were no statistically significant differences between groups in pain, itch or laser Doppler measures of perfusion.","['This two-arm, single-centre RCT recruited children with acute thermal burns covering less than 5 per cent of their total body surface area', 'paediatric burns', '114 patients were randomized', 'small-area thermal burns in children']","['adjunctive NPWT', 'negative pressure wound therapy', 'standard Acticoat™ and Mepitel™ dressings with combined Acticoat™, Mepitel™ and continuous NPWT', 'negative pressure wound therapy (NPWT']","['pain, itch or laser Doppler measures of perfusion', 'time to wound closure', 'time to re-epithelialization', 'risk of referral to scar management', 'pain, itch, grafting, perfusion and scar management referrals', 'Median time to re-epithelialization']","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0701836', 'cui_str': 'Thermal burn'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0562018', 'cui_str': 'cent'}, {'cui': 'C0229978', 'cui_str': '90 percent of body surface or more'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}]","[{'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0763683', 'cui_str': 'Acticoat'}, {'cui': 'C0758246', 'cui_str': 'mepitel'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0430489', 'cui_str': 'Laser doppler'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}, {'cui': 'C0334221', 'cui_str': 'Re-epithelialization'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0556498', 'cui_str': 'Scar management'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",114.0,0.0699598,"There were no statistically significant differences between groups in pain, itch or laser Doppler measures of perfusion.","[{'ForeName': 'C C', 'Initials': 'CC', 'LastName': 'Frear', 'Affiliation': ""Centre for Children's Burns and Trauma Research, South Brisbane, Australia.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Cuttle', 'Affiliation': ""Centre for Children's Burns and Trauma Research, South Brisbane, Australia.""}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'McPhail', 'Affiliation': 'Australian Centre for Health Services Innovation and Centre for Healthcare Transformation, School of Public Health and Social Work, Brisbane, Queensland, Australia.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Chatfield', 'Affiliation': 'Faculty of Medicine, University of Queensland, Herston, Australia.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Kimble', 'Affiliation': ""Centre for Children's Burns and Trauma Research, South Brisbane, Australia.""}, {'ForeName': 'B R', 'Initials': 'BR', 'LastName': 'Griffin', 'Affiliation': ""Centre for Children's Burns and Trauma Research, South Brisbane, Australia.""}]",The British journal of surgery,['10.1002/bjs.11993'] 1350,32930794,Making community-supported agriculture accessible to low-income families: findings from the Farm Fresh Foods for Healthy Kids process evaluation.,"A randomized trial of Farm Fresh Foods for Healthy Kids (F3HK) was initiated across 4 states and 12 farms to test whether cost-offset community-supported agriculture (CO-CSA) could improve diet quality among children in low-income families. Intervention households purchased a 50% subsidized share of local produce and were invited to nine complimentary nutrition classes. The purpose of this study was to assess F3HK reach, dose, and fidelity via a mixed methods process evaluation. Screening and enrollment records indicated reach; study records and postlesson educator surveys tracked dose delivered; CSA pickup logs, lesson sign-in sheets, postseason participant surveys, and postlesson caregiver surveys assessed dose received; and coordinator audits and educator surveys tracked fidelity. Educator interviews contextualized findings. The results of this study were as follows. Reach: enrolled caregivers (n = 305) were older (p = .005) than eligible nonenrollees (n = 243) and more likely to be female (p < .001). Dose: mean CSA season was 21 weeks (interquartile range [IQR]: 19-23). Median CSA pickup was 88% of the weeks (IQR: 40-100). All sites offered each class at least once. Most adults (77%) and children (54%) attended at least one class; few attended all. Eighty-two percent of caregivers indicated that their household consumed most or all produce. Median lesson activity ratings were 5/5 (""very useful""). Fidelity: CSA locations functioned with integrity to project standards. Educators taught 92% of activities but frequently modified lesson order. This study demonstrates the feasibility of pairing a CO-CSA intervention with nutrition education across geographically dispersed sites. Greater integration of intervention elements and clearer allowance for site-level modifications, particularly for educational elements, may improve intervention dose and, ultimately, impact.",2021,Reach: enrolled caregivers (n = 305) were older (p = .005) than eligible nonenrollees (n = 243) and more likely to be female (p < .001).,"['Intervention households purchased a 50% subsidized share of local produce and were invited to nine complimentary nutrition classes', 'Healthy Kids (F3HK', 'children in low-income families', 'Most adults (77%) and children (54%) attended at least one class; few attended all']","['Farm Fresh Foods', 'CO-CSA intervention', 'cost-offset community-supported agriculture (CO-CSA']","['diet quality', 'Median lesson activity ratings', 'Fidelity', 'Median CSA pickup']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]","[{'cui': 'C0557759', 'cui_str': 'Farming environment'}, {'cui': 'C0453829', 'cui_str': 'Fresh food'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0001829', 'cui_str': 'Farming'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}]",305.0,0.0588827,Reach: enrolled caregivers (n = 305) were older (p = .005) than eligible nonenrollees (n = 243) and more likely to be female (p < .001).,"[{'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Garner', 'Affiliation': 'School of Health and Rehabilitation Sciences, College of Medicine, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Stephanie B', 'Initials': 'SB', 'LastName': 'Jilcott Pitts', 'Affiliation': 'Brody School of Medicine, Department of Public Health, East Carolina University, Greenville, NC, USA.'}, {'ForeName': 'Karla L', 'Initials': 'KL', 'LastName': 'Hanson', 'Affiliation': 'Master of Public Health Program, Department of Population Medicine and Diagnostic Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Alice S', 'Initials': 'AS', 'LastName': 'Ammerman', 'Affiliation': 'Gillings School of Global Public Health and School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Kolodinsky', 'Affiliation': 'Department of Community Development and Applied Economics, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Marilyn H', 'Initials': 'MH', 'LastName': 'Sitaker', 'Affiliation': 'Ecological Agriculture and Food Systems, The Evergreen State College, Olympia, WA, USA.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Seguin-Fowler', 'Affiliation': 'Department of Nutrition and Food Science, Texas A&M University, College Station, TX, USA.'}]",Translational behavioral medicine,['10.1093/tbm/ibaa080'] 1351,32925634,Customized Probability of Vaginal Delivery With Induction of Labor and Expectant Management in Nulliparous Women at 39 Weeks of Gestation.,"OBJECTIVE To develop models to predict vaginal delivery in low-risk, nulliparous women contemplating elective induction of labor or expectant management at 39 weeks of gestation. METHODS We conducted a secondary analysis of a randomized controlled trial of planned elective induction of labor at 39 weeks of gestation compared with expectant management for low-risk nulliparous women. Two groups were included for this analysis: 1) women who were randomized to the induction of labor group and underwent elective induction at 39 0/7-39 4/7 weeks of gestation and 2) women who were randomized to the expectant management group who experienced spontaneous labor or medically indicated delivery (including postterm). Multivariable logistic regression models were developed for each group using patient characteristics that would be available at the time of counseling. Model selection was based on k-fold cross-validation using backward elimination and variables that remained significant at P<.05 were retained. To compare estimated with observed rates, the elective induction of labor model was then applied to each woman in both groups to estimate individualized predicted probabilities of vaginal delivery with elective induction of labor. RESULTS Of 6,106 women enrolled in the trial, 4,661 met criteria for this analysis. Vaginal delivery occurred in 80.6% of the 2,153 women in the elective induction of labor group and 77.2% of the 2,508 women in the expectant management group (P=.005). The final elective induction of labor model included age, height, weight, and modified Bishop score (area under the receiver operating characteristic curve [AUROC] 0.72, 95% CI 0.70-0.75). The same variables were included in the final expectant management model (AUROC 0.70, 95% CI 0.67-0.72). Across the range of predicted probability deciles derived from the elective induction of labor model, almost all women who underwent elective induction of labor at 39 weeks of gestation had a higher observed chance of vaginal delivery than expectant management. CONCLUSION Irrespective of the individual predicted chance of vaginal delivery from elective induction of labor at 39 weeks of gestation, vaginal delivery is generally more frequent if elective induction of labor is undertaken rather than expectant management. These data can be used to counsel nulliparous women regarding their ""customized"" chances of vaginal delivery as they choose between elective induction of labor or expectant management at 39 weeks of gestation. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, NCT01990612.",2020,"Vaginal delivery occurred in 80.6% of the 2,153 women in the elective induction of labor group and 77.2% of the 2,508 women in the expectant management group (P=.005).","['Nulliparous Women at 39 Weeks of Gestation', 'counsel nulliparous women', 'low-risk, nulliparous women contemplating elective induction of labor or expectant management at 39 weeks of gestation', 'low-risk nulliparous women', '6,106 women enrolled in the trial', 'Two groups were included for this analysis: 1) women who were randomized to the induction of labor group and underwent elective induction at 39 0/7-39 4/7 weeks of gestation and 2) women who were randomized to the']","['Vaginal Delivery With Induction of Labor and Expectant Management', 'expectant management group who experienced spontaneous labor or medically indicated delivery (including postterm', 'expectant management', 'planned elective induction of labor']","['Vaginal delivery', 'chance of vaginal delivery']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0474461', 'cui_str': 'Spontaneous onset of labor'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}]",6106.0,0.0517142,"Vaginal delivery occurred in 80.6% of the 2,153 women in the elective induction of labor group and 77.2% of the 2,508 women in the expectant management group (P=.005).","[{'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': ""Departments of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City, Utah, Northwestern University, Chicago, Illinois, University of Alabama at Birmingham, Birmingham, Alabama, Stanford University, Stanford, California, Columbia University, New York, New York, Brown University, Providence, Rhode Island, University of Texas Medical Branch, Galveston, Texas, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas, The Ohio State University, Columbus, Ohio, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio, University of Texas Southwestern Medical Center, Dallas, Texas, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, Colorado, University of Pennsylvania, Philadelphia, Pennsylvania, Duke University, Durham, North Carolina, University of Pittsburgh, Pittsburgh, Pennsylvania, and Washington University in St. Louis, St. Louis, Missouri; the George Washington University Biostatistics Center, Washington, DC; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.""}, {'ForeName': 'Madeline Murguia', 'Initials': 'MM', 'LastName': 'Rice', 'Affiliation': ''}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Grobman', 'Affiliation': ''}, {'ForeName': 'Uma M', 'Initials': 'UM', 'LastName': 'Reddy', 'Affiliation': ''}, {'ForeName': 'Alan T N', 'Initials': 'ATN', 'LastName': 'Tita', 'Affiliation': ''}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Mallett', 'Affiliation': ''}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Thom', 'Affiliation': ''}, {'ForeName': 'Yasser Y', 'Initials': 'YY', 'LastName': 'El-Sayed', 'Affiliation': ''}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Wapner', 'Affiliation': ''}, {'ForeName': 'Dwight J', 'Initials': 'DJ', 'LastName': 'Rouse', 'Affiliation': ''}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Saade', 'Affiliation': ''}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Thorp', 'Affiliation': ''}, {'ForeName': 'Suneet P', 'Initials': 'SP', 'LastName': 'Chauhan', 'Affiliation': ''}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Chien', 'Affiliation': ''}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Casey', 'Affiliation': ''}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Gibbs', 'Affiliation': ''}, {'ForeName': 'Sindhu K', 'Initials': 'SK', 'LastName': 'Srinivas', 'Affiliation': ''}, {'ForeName': 'Geeta K', 'Initials': 'GK', 'LastName': 'Swamy', 'Affiliation': ''}, {'ForeName': 'Hyagriv N', 'Initials': 'HN', 'LastName': 'Simhan', 'Affiliation': ''}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Macones', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004046'] 1352,32926247,The effect of intravenous golimumab on health-related quality of life and work productivity in adult patients with active ankylosing spondylitis: results of the phase 3 GO-ALIVE trial.,"INTRODUCTION/OBJECTIVES The effect of intravenous (IV) golimumab on health-related quality of life (HRQoL) and productivity in patients with ankylosing spondylitis (AS) was evaluated. METHOD Patients were randomized to IV golimumab 2 mg/kg (n = 105) at weeks 0, 4, then every 8 weeks (q8w) through week 52 or placebo (n = 103) at weeks 0, 4, 12, with crossover to golimumab 2 mg/kg at weeks 16, 20, then q8w through week 52. Changes from baseline in EuroQol-5 dimension-5 level (EQ-5D-5L) index and visual analog scale (EQ-VAS), daily productivity VAS, Work Limitations Questionnaire (WLQ), and Ankylosing Spondylitis Quality of Life (ASQoL) were assessed. Correlations between these outcomes and disease activity and patient functioning outcomes were evaluated post hoc. RESULTS At week 16, changes from baseline (mean ± standard deviation) in EQ-5D-5L index (0.17 ± 0.16 vs 0.05 ± 0.14), EQ-VAS (20.3 ± 24.6 vs 4.8 ± 23.5), daily productivity VAS (- 2.9 ± - 2.9 vs - 1.1 ± - 2.5), WLQ productivity loss score (- 3.5 ± - 5.3 vs - 1.9 ± - 4.0), and ASQoL (- 5.4 ± - 5.0 vs - 1.8 ± - 4.5) were greater in the IV golimumab versus placebo group, respectively. At week 28, changes from baseline were similar between the IV golimumab and placebo-crossover groups (EQ-5D-5L index: 0.18 ± 0.17 and 0.16 ± 0.16, EQ-VAS: 20.5 ± 27.9 and 22.5 ± 23.1, daily productivity VAS: - 3.1 ± - 3.0 and - 3.1 ± - 2.8, WLQ productivity loss: - 3.9 ± - 5.5 and - 4.5 ± - 4.5, and ASQoL: - 5.3 ± - 5.2 and - 5.3 ± - 4.8, respectively); improvements were maintained through week 52. HRQoL and productivity outcomes were generally moderately correlated with disease activity and functioning outcomes. CONCLUSIONS In patients with AS, IV golimumab produced sustained improvements in HRQoL and productivity through 1 year, which correlated with improvements in disease activity and functioning. ClinicalTrials.gov registry number is NCT02186873. Key Points • Intravenous (IV) golimumab resulted in clinically important improvement in general and ankylosing spondylitis-specific health-related quality of life (HRQoL) and productivity outcomes in patients with ankylosing spondylitis (AS) as early as week 8 and maintained improvement through 1 year • Improvements in HRQoL and productivity outcomes in these patients with AS were correlated with improvements in measures of disease activity and patient functional capability • IV golimumab is an effective treatment option for AS that can help mitigate the negative effects of the disease on HRQoL and productivity.",2021,Intravenous (IV) golimumab resulted in clinically important improvement in general and ankylosing spondylitis-specific health-related quality of life (HRQoL) and productivity outcomes in patients with ankylosing spondylitis (AS) as early as week 8 and maintained improvement through 1 year • Improvements in HRQoL and productivity outcomes in these patients with AS were correlated with improvements in measures of disease activity and patient functional capability • IV golimumab is an effective treatment option for AS that can help mitigate the negative effects of the disease on HRQoL and productivity.,"['adult patients with active ankylosing spondylitis', 'patients with ankylosing spondylitis (AS', 'Patients']","['intravenous golimumab', 'placebo', 'Intravenous (IV) golimumab', 'intravenous (IV) golimumab']","['HRQoL and productivity', 'health-related quality of life (HRQoL) and productivity', 'disease activity and functioning', 'disease activity and patient functioning outcomes', 'disease activity and functioning outcomes', 'EQ-5D-5L index', 'daily productivity VAS', 'WLQ productivity loss score', 'EuroQol-5 dimension-5 level (EQ-5D-5L) index and visual analog scale (EQ-VAS), daily productivity VAS, Work Limitations Questionnaire (WLQ), and Ankylosing Spondylitis Quality of Life (ASQoL', 'health-related quality of life and work productivity', 'HRQoL and productivity outcomes', 'general and ankylosing spondylitis-specific health-related quality of life (HRQoL) and productivity outcomes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C2353893', 'cui_str': 'golimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",,0.223187,Intravenous (IV) golimumab resulted in clinically important improvement in general and ankylosing spondylitis-specific health-related quality of life (HRQoL) and productivity outcomes in patients with ankylosing spondylitis (AS) as early as week 8 and maintained improvement through 1 year • Improvements in HRQoL and productivity outcomes in these patients with AS were correlated with improvements in measures of disease activity and patient functional capability • IV golimumab is an effective treatment option for AS that can help mitigate the negative effects of the disease on HRQoL and productivity.,"[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Reveille', 'Affiliation': 'Department of Internal Medicine, Division of Rheumatology, The University of Texas McGovern Medical School, 6431 Fannin, MSB 5.270, Houston, TX, USA. Reveille@uth.tmc.edu.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Hwang', 'Affiliation': 'Department of Internal Medicine, Division of Rheumatology, The University of Texas McGovern Medical School, 6431 Fannin, MSB 5.270, Houston, TX, USA.'}, {'ForeName': 'Abhijeet', 'Initials': 'A', 'LastName': 'Danve', 'Affiliation': 'Section of Rheumatology, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Kafka', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, PA, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Peterson', 'Affiliation': 'Janssen Global Services, LLC, Horsham, PA, USA.'}, {'ForeName': 'Kim Hung', 'Initials': 'KH', 'LastName': 'Lo', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Lilianne', 'Initials': 'L', 'LastName': 'Kim', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Hsia', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Eric K H', 'Initials': 'EKH', 'LastName': 'Chan', 'Affiliation': 'Patient Reported Outcomes, Janssen Global Services, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Deodhar', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}]",Clinical rheumatology,['10.1007/s10067-020-05342-7'] 1353,32932273,Shave Excision Versus Elliptical Excision of Nonpigmented Intradermal Melanocytic Nevi: Comparative Assessment of Recurrence and Cosmetic Outcomes.,"BACKGROUND Nonpigmented intradermal melanocytic nevi (IMN) are benign lesions often removed for cosmetic reasons. There is no consensus as to the best technique for IMN excision. OBJECTIVE To compare cosmetic outcomes and risk of recurrence after shave excision versus elliptical excision of IMN. MATERIALS AND METHODS In this randomized clinical trial, patients underwent shave excision or elliptical excision with sutured closure of IMN of the face or back. Recurrence, patient satisfaction, cosmetic outcome, postoperative discomfort, scar size, discoloration, and presence of hypertrophic or keloid scars were evaluated at 3, 6, and 9 months. RESULTS Overall, 145 nevi were removed from 45 patients (86.7% women, mean age 52.1 ± 12.5 years). The recurrence rate was 11.7%, occurring only after shave excision; 94.1% of recurrences were observed at 3-month follow-up. Shave excision was associated with less discomfort 48 hours after intervention but a greater likelihood of involved lateral and deep margins (p < .001). Scars were larger after elliptical excision and suture than after shave excision (p < .01). The mean patient satisfaction was higher in the shave excision group (p < .004). CONCLUSION Shave excision of IMN is associated with higher rates of involved surgical margins and recurrence than elliptical excision but provides superior cosmesis and patient satisfaction.",2021,Shave excision of IMN is associated with higher rates of involved surgical margins and recurrence than elliptical excision but provides superior cosmesis and patient satisfaction.,"['145 nevi were removed from 45 patients (86.7% women, mean age 52.1 ± 12.5 years']","['shave excision or elliptical excision with sutured closure of IMN of the face or back', 'intradermal melanocytic nevi (IMN', 'Shave Excision Versus Elliptical Excision of Nonpigmented Intradermal Melanocytic Nevi', 'shave excision versus elliptical excision of IMN']","['recurrence rate', 'Recurrence, patient satisfaction, cosmetic outcome, postoperative discomfort, scar size, discoloration, and presence of hypertrophic or keloid scars', 'mean patient satisfaction']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0027960', 'cui_str': 'Nevi'}, {'cui': 'C1292747', 'cui_str': 'Removes from'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0567344', 'cui_str': 'Shave excision'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0027962', 'cui_str': 'Melanocytic nevus'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0022548', 'cui_str': 'Keloid'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",145.0,0.0280356,Shave excision of IMN is associated with higher rates of involved surgical margins and recurrence than elliptical excision but provides superior cosmesis and patient satisfaction.,"[{'ForeName': 'Leandra', 'Initials': 'L', 'LastName': 'Camini', 'Affiliation': 'Department of Dermatology, Universidade Federal de Ciências da Saúde Porto Alegre (UFCSPA), Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Ana Paula Dornelles', 'Initials': 'APD', 'LastName': 'Manzoni', 'Affiliation': 'Department of Dermatology, Universidade Federal de Ciências da Saúde Porto Alegre (UFCSPA), Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Magda Blessmann', 'Initials': 'MB', 'LastName': 'Weber', 'Affiliation': 'Department of Dermatology, Universidade Federal de Ciências da Saúde Porto Alegre (UFCSPA), Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Luzzato', 'Affiliation': 'Department of Dermatology, Universidade Federal de Ciências da Saúde Porto Alegre (UFCSPA), Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Andréa Santos', 'Initials': 'AS', 'LastName': 'Soares', 'Affiliation': 'Dermatologist in Private Practice, Florianópolis, Santa Catarina, Brazil.'}, {'ForeName': 'Renan Rangel', 'Initials': 'RR', 'LastName': 'Bonamigo', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Universidade Federal de do Rio Grande do Sul (UFRGS), Porto Alegre, Rio Grande do Sul, Brazil.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002666'] 1354,32932396,Corneal Health during Three Months of Scleral Lens Wear.,"SIGNIFICANCE This study evaluated the effects scleral lens wear has on corneal health using fluorometry and in vivo confocal microscopy. No subclinical changes on healthy corneas of young subjects were observed during 3 months of scleral lens wear. PURPOSE This study aimed to evaluate the effects 3 months of scleral lens wear has on the corneal epithelial barrier function, dendritic cell density, and nerve fiber morphology. METHODS Twenty-seven neophytes (mean [standard deviation] age, 21.4 [3.9] years) wore scleral lenses of a fluorosilicone acrylate material bilaterally (97 Dk, 15.6 to 16.0-mm diameter) for 3 months without overnight wear. Subjects were randomized to use either Addipak (n = 12) or PuriLens Plus (n = 15) during lens insertion. Measurements of corneal epithelial permeability to fluorescein were performed with automated scanning fluorophotometer (Fluorotron Master; Ocumetrics, Mountain View, CA) on the central cornea of the right eye and the temporal corneal periphery of the left eye. Images of the distributions of corneal nerve fibers and dendritic cells and nerve fibers were captured in vivo with a confocal laser scanning microscope (Heidelberg Retina Tomograph, Rostock Cornea Module; Heidelberg Engineering, Heidelberg, Germany) on the central and inferior peripheral cornea of the left eye. Corneal measurements and imaging were performed at baseline and after 1 and 3 months of lens wear. RESULTS The corneal permeability values in natural log, dendritic cell densities, and nerve fiber morphology did not significantly change from baseline to 1 and 3 months of lens wear, for both central and peripheral corneal regions (P > .05). Dendritic cell density at the inferior cornea was higher than the central cornea throughout the study (P < .001). No relationships were observed between each outcome measurements and the saline solution groups (P > .05). CONCLUSIONS Scleral lens wear for 3 months on healthy cornea of young subjects did not affect corneal epithelial barrier function, nerve fiber, and dendritic cell densities. Buffered and nonbuffered saline solutions impacted the corneal health in similar ways.",2020,Dendritic cell density at the inferior cornea was higher than the central cornea throughout the study (P < .001).,"['Twenty-seven neophytes (mean [standard deviation] age, 21.4 [3.9] years) wore scleral lenses of a fluorosilicone acrylate material bilaterally (97 Dk, 15.6 to 16.0-mm diameter) for 3 months without overnight wear']","['Addipak (n = 12) or PuriLens Plus', 'Buffered and nonbuffered saline solutions']","['corneal epithelial barrier function, dendritic cell density, and nerve fiber morphology', 'corneal permeability values in natural log, dendritic cell densities, and nerve fiber morphology', 'corneal health', 'Corneal Health', 'corneal epithelial permeability', 'corneal epithelial barrier function, nerve fiber, and dendritic cell densities', 'Dendritic cell density']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0101303', 'cui_str': 'acrylate'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0003315', 'cui_str': 'Immunologic Accessory Cells'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0027749', 'cui_str': 'Nerve fiber'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0498456,Dendritic cell density at the inferior cornea was higher than the central cornea throughout the study (P < .001).,"[{'ForeName': 'Vivien', 'Initials': 'V', 'LastName': 'Tse', 'Affiliation': 'Clinical Research Center, School of Optometry, University of California, Berkeley, Berkeley, California.'}, {'ForeName': 'Yixiu', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Clinical Research Center, School of Optometry, University of California, Berkeley, Berkeley, California.'}, {'ForeName': 'Tan', 'Initials': 'T', 'LastName': 'Truong', 'Affiliation': 'Clinical Research Center, School of Optometry, University of California, Berkeley, Berkeley, California.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Lin', 'Affiliation': 'Clinical Research Center, School of Optometry, University of California, Berkeley, Berkeley, California.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Tan', 'Affiliation': 'Clinical Research Center, School of Optometry, University of California, Berkeley, Berkeley, California.'}, {'ForeName': 'Meng C', 'Initials': 'MC', 'LastName': 'Lin', 'Affiliation': ''}]",Optometry and vision science : official publication of the American Academy of Optometry,['10.1097/OPX.0000000000001566'] 1355,32932393,Effect of Scleral Lens Oxygen Permeability on Corneal Physiology.,"SIGNIFICANCE This randomized, masked, crossover clinical study identifies that ≥125 Dk materials should be used for scleral lens daily wear if disruption to corneal oxygen is to be minimized. PURPOSE Modern scleral lens use has increased and has proven to be successful where other types and materials have previously failed. Although the required oxygen permeability has been modeled, this has not been established clinically. METHODS Fifteen masked participants aged 20.7 ± 2.3 years (10 female) were bilaterally fitted with five different scleral lenses (65, 100, 125, 163, and 180+ Dk) of the same shape profile and one soft silicone hydrogel lens compared with no lens wear on separate occasions in a randomized order. A masked researcher measured corneal thickness and fluid reservoir depth, corneal curvature, objective bulbar and limbal redness, corneal biomechanics, and ocular surface oxygen consumption before and after 8 hours of wear. In addition, comfort scores were obtained using a visual analog scale. RESULTS Scleral lenses with oxygen permeability of 65 Dk resulted in greater corneal thickness (1.37 ± 1.25%) after 8 hours of wear versus ≥100 Dk materials (0.58 ± 0.99%; F = 17.215, P < .001) because of stromal thickening; edema with ≥100 Dk materials was associated with fluid reservoir depth (r = 0.231, P = .05). Fluid reservoir depth decreased similarly with all oxygen-permeable lenses from 325.6 ± 99.1 μm to 174.2 ± 100.8 μm after 8 hours of wear (F = 0.961, P = .44). Oxygen consumption reduced with ≤125 Dk lenses (χ = 604.196, P < .001). Soft and scleral lens wear had no effect on corneal curvature, corneal biomechanics, or ocular hyperemia (P > .05). Soft lenses were more comfortable than all the scleral lenses (P < .05), and the 180+ Dk lenses had the best comfort among the sclerals (P < .05). CONCLUSIONS A ≥125 Dk is advised for safe scleral lens daily wear. Scleral lens wear leads to an increase in corneal thickness, regardless of lens-material oxygen permeability because of the fluid reservoir depth.",2020,"Oxygen consumption reduced with ≤125 Dk lenses (χ = 604.196, P < .001).","['Fifteen masked participants aged 20.7 ± 2.3 years (10 female', 'Corneal Physiology']","['Scleral Lens Oxygen Permeability', 'silicone hydrogel lens compared with no lens wear on separate occasions']","['Oxygen consumption', 'corneal thickness, regardless of lens-material oxygen permeability', 'Fluid reservoir depth', 'corneal thickness and fluid reservoir depth, corneal curvature, objective bulbar and limbal redness, corneal biomechanics, and ocular surface oxygen consumption', 'corneal thickness', 'corneal curvature, corneal biomechanics, or ocular hyperemia', 'fluid reservoir depth']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}]","[{'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel'}, {'cui': 'C0443299', 'cui_str': 'Separate'}]","[{'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0429493', 'cui_str': 'Corneal thickness'}, {'cui': 'C0450437', 'cui_str': 'Lens material'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0442537', 'cui_str': 'Reservoir'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0443251', 'cui_str': 'Limbal'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0155169', 'cui_str': 'Ocular hyperemia'}]",15.0,0.0844741,"Oxygen consumption reduced with ≤125 Dk lenses (χ = 604.196, P < .001).","[{'ForeName': 'Sandeep K', 'Initials': 'SK', 'LastName': 'Dhallu', 'Affiliation': 'Ophthalmic Research Group, Aston University, Birmingham, United Kingdom.'}, {'ForeName': 'Sonia Trave', 'Initials': 'ST', 'LastName': 'Huarte', 'Affiliation': ''}, {'ForeName': 'Paramdeep S', 'Initials': 'PS', 'LastName': 'Bilkhu', 'Affiliation': ''}, {'ForeName': 'Nikolay', 'Initials': 'N', 'LastName': 'Boychev', 'Affiliation': ''}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Wolffsohn', 'Affiliation': ''}]",Optometry and vision science : official publication of the American Academy of Optometry,['10.1097/OPX.0000000000001557'] 1356,32933346,Post-marketing surveillance of high-dose methotrexate (>8 mg/week) in Japanese patients with rheumatoid arthritis: A post hoc sub-analysis of patients according to duration of prior methotrexate use.,"OBJECTIVES To explore whether the duration of prior low-dose methotrexate treatment (MTX; ≤8 mg/week) influences the safety and effectiveness of high-dose MTX (>8 mg/week) in Japanese patients with rheumatoid arthritis (RA). METHODS This post hoc sub-analysis of a Japanese post-marketing surveillance study evaluated patients initiating high-dose MTX with ≥1 year or <1 year prior low-dose MTX use. Over 24 or 52 weeks, adverse drug reactions (ADRs) were monitored, and effectiveness was assessed using the Disease Activity Score in 28 joints, erythrocyte sedimentation rate [DAS28-4 (ESR)]. RESULTS One thousand two hundred and ninety-two MTX ≥1 year and 1001 MTX <1 year patients were included. The incidence of ADRs during the 24- and 52-week follow-up period was significantly more frequent in MTX <1 year than ≥1 year patients and serious ADRs were significantly higher in MTX <1 year than ≥1 year patients during the 52-week follow-up period (all p  < .05). Over both follow-up periods, the mean DAS28-4 (ESR) significantly decreased from baseline for all groups. Remission and low disease activity rates (DAS28-4 (ESR) <2.6 and <3.2, respectively) increased from baseline for all groups. CONCLUSION High-dose MTX reduced disease activity regardless of prior treatment duration, but ADRs occurred more frequently among MTX <1 year patients compared to MTX ≥1 year patients.",2021,"Over both follow-up periods, the mean DAS28-4(ESR) significantly decreased from baseline for all groups.","['Japanese patients with rheumatoid arthritis', 'Japanese patients with rheumatoid arthritis (RA', 'patients initiating high-dose MTX with ≥1 year or <1 year prior low-dose MTX use']","['methotrexate', 'MTX', 'methotrexate treatment (MTX']","['disease activity', 'mean DAS28-4(ESR', 'adverse drug reactions (ADRs', 'Remission and low disease activity rates', 'Disease Activity Score in 28 joints, erythrocyte sedimentation rate (DAS28-4[ESR', 'incidence of ADRs', 'safety and effectiveness', 'serious ADRs']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0340984,"Over both follow-up periods, the mean DAS28-4(ESR) significantly decreased from baseline for all groups.","[{'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Tokai University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Hirose', 'Affiliation': 'Atopy (Allergy) Research Center, Juntendo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Sugiyama', 'Affiliation': 'Clinical Statistics, Biometrics and Data Management, Pfizer R&D Japan, Tokyo, Japan.'}, {'ForeName': 'Kazuto', 'Initials': 'K', 'LastName': 'Nomura', 'Affiliation': 'Post-Marketing Study Strategy and Management, Development Japan, Pfizer R&D Japan, Tokyo, Japan.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Campos-Alberto', 'Affiliation': 'Immunology and Inflammation Medical Affairs, Pfizer Innovative Health, Pfizer Japan Inc, Tokyo, Japan.'}]",Modern rheumatology,['10.1080/14397595.2020.1823604'] 1357,32933746,Postoperative delirium is associated with decreased recovery of ambulation one-month after surgery.,"BACKGROUND We hypothesized that postoperative delirium is associated with diminished recovery toward baseline preoperative ambulation levels one-month postoperatively. METHODS Patients included were ≥60 years old undergoing inpatient operations. Ambulation was measured as steps/day using an accelerometer worn for ≥3-days preoperatively and ≥28-days postoperatively. Primary outcome was the percent recovery of preoperative steps. RESULTS 109 patients were included; 17 (16%) developed postoperative delirium. Recovery of ambulation toward preoperative baseline at postoperative day-28 was decreased in delirium group (34% vs. 69%; p < 0.01). Immediate postoperative ambulation was similar in the delirium vs. no-delirium groups (p = 0.79). Delirium occurred on average on postoperative 3 ± 4 days. Subsequently, ambulation was decreased in the delirium group compared to non-delirium group at postoperative week-1 (p = 0.01), week-2 (p = 0.02), week-3 (p < 0.01) and week-4 (p < 0.01). CONCLUSION Patients undergoing inpatient operations who develop delirium recover only one-third of their baseline steps one-month postoperatively. Postoperative delirium results in a decreased recovery towards baseline ambulation for at least 4-weeks following major operations in comparison to non-delirious patients. The decrease in ambulation in the delirium versus no-delirium groups occurred after the occurrence of postoperative delirium.",2021,Immediate postoperative ambulation was similar in the delirium vs. no-delirium groups (p = 0.79).,['Patients included were ≥60 years old undergoing inpatient operations'],[],"['Delirium', 'ambulation', 'Immediate postoperative ambulation', 'postoperative delirium', 'percent recovery of preoperative steps', 'Ambulation', 'Recovery of ambulation toward preoperative baseline at postoperative day-28']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",[],"[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",109.0,0.17125,Immediate postoperative ambulation was similar in the delirium vs. no-delirium groups (p = 0.79).,"[{'ForeName': 'Thomas N', 'Initials': 'TN', 'LastName': 'Robinson', 'Affiliation': 'Department of Surgery, Rocky Mountain Regional Veterans Affairs Medical Center, Aurora, CO, USA; Department of Surgery, University of Colorado, Aurora, CO, USA. Electronic address: thomas.robinson@cuanschutz.edu.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kovar', 'Affiliation': 'Department of Surgery, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Carmichael', 'Affiliation': 'Department of Surgery, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Doug M', 'Initials': 'DM', 'LastName': 'Overbey', 'Affiliation': 'Department of Surgery, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Goode', 'Affiliation': 'Department of Surgery, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Teresa S', 'Initials': 'TS', 'LastName': 'Jones', 'Affiliation': 'Department of Surgery, Rocky Mountain Regional Veterans Affairs Medical Center, Aurora, CO, USA; Department of Surgery, University of Colorado, Aurora, CO, USA.'}]",American journal of surgery,['10.1016/j.amjsurg.2020.08.031'] 1358,32940866,"Long Alimentary Limb Duodenal Switch (LADS): an Exploratory Randomized Trial, Results at 2 Years.","PURPOSE The effectiveness of the standard biliopancreatic diversion with duodenal switch (BPD/DS) in terms of weight loss has been demonstrated. Increasing the strict alimentary limb length while maintaining the length of the common channel could lead to similar weight loss while reducing side effects. MATERIALS AND METHODS The objective was to evaluate the effect of increasing the strict alimentary limb length on weight loss, comorbidities, nutritional deficiencies, and quality of life 2 years after surgery, compared with standard BPD/DS. An exploratory randomized, double-blind study evaluated the results of LADS at 2 years in comparison with the standard BPD/DS. Common channel was kept at 100 cm in both groups while alimentary limb was created at 100 cm from Treitz angle in the LADS group and at 150 cm total in the BPD/DS group. RESULTS Twenty patients were recruited from May 2013 to June 2015. Mean percentage of excess weight loss was statistically significantly lower in the LADS group at 24 months (81.6 ± 6.6% in the LADS group and 97.1 ± 11.1% in the BPD/DS group (p = 0.001). No significant difference regarding the rate of remission of comorbidities was noted. Mean calcium, vitamin D, hemoglobin, zinc, and copper levels were statistically lower in the BPD/DS group. Quality of life was significantly improved in both groups, with no statistically significant difference between the two groups. CONCLUSIONS At 24 months, weight loss was lower in the LADS group. However, no difference was observed in the improvement in quality of life. LADS technique was discontinued following this study. TRIAL REGISTRATION ClinicalTrial.gov Ref. NCT03097926.",2020,"Quality of life was significantly improved in both groups, with no statistically significant difference between the two groups. ","['Long Alimentary Limb Duodenal Switch (LADS', 'Twenty patients were recruited from May 2013 to June 2015']","['standard BPD/DS', 'LADS', 'standard biliopancreatic diversion with duodenal switch (BPD/DS']","['weight loss', 'Mean percentage of excess weight loss', 'Mean calcium, vitamin D, hemoglobin, zinc, and copper levels', 'rate of remission of comorbidities', 'weight loss, comorbidities, nutritional deficiencies, and quality of life 2\xa0years', 'Quality of life', 'quality of life']","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C1960687', 'cui_str': 'Duodenal switch'}, {'cui': 'C0226032', 'cui_str': 'Structure of anterior descending branch of left coronary artery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005435', 'cui_str': 'Biliopancreatic bypass'}, {'cui': 'C1960687', 'cui_str': 'Duodenal switch'}, {'cui': 'C0226032', 'cui_str': 'Structure of anterior descending branch of left coronary artery'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0373587', 'cui_str': 'Copper measurement'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439234', 'cui_str': 'year'}]",20.0,0.0536809,"Quality of life was significantly improved in both groups, with no statistically significant difference between the two groups. ","[{'ForeName': 'François-Charles', 'Initials': 'FC', 'LastName': 'Malo', 'Affiliation': 'Department of surgery, Centre hospitalier universitaire de Sherbrooke - Université de Sherbrooke, Sherbrooke, Québec, Canada. francois-charles.malo@usherbrooke.ca.'}, {'ForeName': 'Andréanne', 'Initials': 'A', 'LastName': 'Marion', 'Affiliation': 'Department of surgery, Centre hospitalier universitaire de Sherbrooke - Université de Sherbrooke, Sherbrooke, Québec, Canada.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Rioux', 'Affiliation': 'Department of surgery, Centre hospitalier universitaire de Sherbrooke - Université de Sherbrooke, Sherbrooke, Québec, Canada.'}, {'ForeName': 'Stéfane', 'Initials': 'S', 'LastName': 'Lebel', 'Affiliation': 'Department of surgery, Institut universitaire de cardiologie et pneumologie de Québec - Université Laval, Québec, Canada.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Hould', 'Affiliation': 'Department of surgery, Institut universitaire de cardiologie et pneumologie de Québec - Université Laval, Québec, Canada.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Julien', 'Affiliation': 'Department of surgery, Institut universitaire de cardiologie et pneumologie de Québec - Université Laval, Québec, Canada.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Marceau', 'Affiliation': 'Department of surgery, Institut universitaire de cardiologie et pneumologie de Québec - Université Laval, Québec, Canada.'}, {'ForeName': 'Odette', 'Initials': 'O', 'LastName': 'Lescelleur', 'Affiliation': 'Department of surgery, Institut universitaire de cardiologie et pneumologie de Québec - Université Laval, Québec, Canada.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Lafortune', 'Affiliation': 'Department of surgery, Institut universitaire de cardiologie et pneumologie de Québec - Université Laval, Québec, Canada.'}, {'ForeName': 'Léonie', 'Initials': 'L', 'LastName': 'Bouvet-Bouchard', 'Affiliation': 'Department of surgery, Institut universitaire de cardiologie et pneumologie de Québec - Université Laval, Québec, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Biertho', 'Affiliation': 'Department of surgery, Institut universitaire de cardiologie et pneumologie de Québec - Université Laval, Québec, Canada.'}]",Obesity surgery,['10.1007/s11695-020-04968-5'] 1359,32935460,"A Randomized, Double-Blind, Placebo- and Positive-Controlled, 4-Period Crossover Study of the Effects of Solriamfetol on QTcF Intervals in Healthy Participants.","Solriamfetol, a dopamine and norepinephrine reuptake inhibitor, is approved (United States and European Union; Sunosi) to treat excessive daytime sleepiness associated with narcolepsy (75-150 mg/day) or obstructive sleep apnea (37.5-150 mg/day). A thorough QT/QTc study assessed solriamfetol effects on QT interval (Fridericia correction for heart rate; QTcF). This randomized, double-blind, placebo- and positive-controlled, 4-period crossover study compared single doses of 300 and 900 mg solriamfetol, 400 mg moxifloxacin, and placebo in healthy adults. Placebo- and predose-adjusted mean differences in QTcF (ddQTcF; primary end point) were analyzed, and solriamfetol pharmacokinetics were characterized. Fifty-five participants completed all periods. Upper bounds of 2-sided 90% confidence intervals (CIs) for ddQTcF for both solriamfetol doses were <10 milliseconds at all postdose time points. Assay sensitivity was demonstrated with moxifloxacin; lower bounds of 2-sided 90%CIs for ddQTcF > 5 milliseconds at 1, 2, and 3 hours postdose. There were no QTcF increases > 60 milliseconds or QTcF values > 480 milliseconds at either solriamfetol dose. Solriamfetol median t max was 2-3 hours; exposure was dose-proportional. More participants experienced adverse events (AEs) after solriamfetol 900 versus 300 mg (70% vs 29%); none were serious (all mild/moderate), and there were no deaths. Common AEs were nausea, dizziness, and palpitations. Neither solriamfetol dose resulted in QTcF prolongation > 10 milliseconds.",2021,There were no QTcF increases > 60 milliseconds or QTcF values > 480 milliseconds at either solriamfetol dose.,"['healthy adults', 'Healthy Participants']","['moxifloxacin', 'solriamfetol, 400\xa0mg moxifloxacin, and placebo', 'placebo', 'Solriamfetol', 'Placebo']","['QTcF prolongation', 'nausea, dizziness, and palpitations', 'Assay sensitivity', 'adverse events (AEs', 'obstructive sleep apnea']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C4726765', 'cui_str': 'Solriamfetol'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0030252', 'cui_str': 'Palpitations'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]",55.0,0.401451,There were no QTcF increases > 60 milliseconds or QTcF values > 480 milliseconds at either solriamfetol dose.,"[{'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Zomorodi', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, California, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, California, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Lee', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, California, USA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Swearingen', 'Affiliation': 'Celerion, Tempe, Arizona, USA.'}, {'ForeName': 'Lawrence P', 'Initials': 'LP', 'LastName': 'Carter', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, California, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.867'] 1360,32935565,Assessment of the Contrast-Enhanced Ultrasound in Percutaneous Nephrolithotomy for the Treatment of Patients with Nondilated Collecting System.,"Purpose: To investigate the clinical value of contrast-enhanced ultrasound (CEUS) in percutaneous nephrolithotomy (PCNL) for kidney stone patients without hydronephrosis. Methods: Patients with nondilated collecting system kidney stones who underwent PCNL between October 2018 and December 2019 at our hospital were enrolled in this study. Patients who met the inclusion criteria were randomized into two groups: a CEUS-guided PCNL group and a conventional ultrasound (US)-guided PCNL group. The operation results of the two groups were compared, including the number of attempts for effective puncture, duration to effective puncture, stone clearance rate, blood loss, postoperative complications, and hospital stay. Results: Fifty-six patients with a nondilated collecting system who underwent PCNL for 60 kidneys were included in this study, including 4 patients who underwent bilateral PCNL due to bilateral renal stones. There were 30 kidneys in each group. All patients successfully underwent PCNL. The CEUS-guided PCNL group had more accurate punctures, with a higher effective rate of one puncture and shorter puncture time. There was no statistically significant difference in stone clearance rate between the two groups. Four cases of double channels were established in the conventional US-guided PCNL group, while there was only one case in the CEUS-guided PCNL group. In the CEUS-guided PCNL group, most cases (96.7%, 29/30) had no or only mild complications, which were significantly better than the conventional US-guided PCNL group (76.7%, 23/30). The mean postoperative hemoglobin loss in the CEUS-guided PCNL group was 9.5 (range 1-25) g/L, which was significantly lower than 15.5 (range 5-52) g/L in the conventional US-guided PCNL group. Conclusion: The CEUS technique can improve visibility of the nondilated renal collecting system, facilitate selection of suitable calix, and identify renal calix fornix. It also benefits needle placement in patients with a nondilated collecting system.",2021,"The CEUS-guided PCNL group had more accurate punctures, with a higher successful rate of one puncture and shorter puncture time.","['Fifty-six patients with a nondilated collecting system who underwent PCNL for sixty kidneys', 'Patients with nondilated collecting system kidney stones who underwent PCNL between October 2018 and December 2019 at our hospital were enrolled in this study', 'kidney stone patients without hydronephrosis', 'Patients who met the inclusion criteria', 'patients with a nondilated collecting system', 'Patients with Nondilated Collecting System']","['CEUS-guided PCNL group and a conventional ultrasound (US)-guided PCNL group', 'contrast-enhanced ultrasound (CEUS', 'Contrast-Enhanced Ultrasound in Percutaneous Nephrolithotomy', 'PCNL', 'percutaneous nephrolithotomy (PCNL', 'bilateral PCNL']","['mild complications', 'number of attempts for successful puncture, duration to successful puncture, stone clearance rate, blood loss, postoperative complications and hospital stay', 'successful rate of one puncture and shorter puncture time', 'mean postoperative hemoglobin loss', 'bilateral renal stones', 'stone clearance rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0020295', 'cui_str': 'Hydronephrosis'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}]",56.0,0.0184341,"The CEUS-guided PCNL group had more accurate punctures, with a higher successful rate of one puncture and shorter puncture time.","[{'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': ""Department of Urology, The Second People's Hospital of China Three Gorges University, The Second People's Hospital of Yichang, Yichang, China.""}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ""Department of Urology, The Second People's Hospital of China Three Gorges University, The Second People's Hospital of Yichang, Yichang, China.""}, {'ForeName': 'Zonglai', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Department of Urology, The Second People's Hospital of China Three Gorges University, The Second People's Hospital of Yichang, Yichang, China.""}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Fu', 'Affiliation': ""Department of Urology, The Second People's Hospital of China Three Gorges University, The Second People's Hospital of Yichang, Yichang, China.""}, {'ForeName': 'Xiaozhan', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': ""Department of Ultrasound, The Second People's Hospital of China Three Gorges University, The Second People's Hospital of Yichang, Yichang, China.""}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': ""Department of Urology, The Second People's Hospital of China Three Gorges University, The Second People's Hospital of Yichang, Yichang, China.""}, {'ForeName': 'Pan', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': ""Department of Urology, The Second People's Hospital of China Three Gorges University, The Second People's Hospital of Yichang, Yichang, China.""}, {'ForeName': 'Xinyu', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Urology, The Second People's Hospital of China Three Gorges University, The Second People's Hospital of Yichang, Yichang, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Ai', 'Affiliation': ""Department of Urology, The Second People's Hospital of China Three Gorges University, The Second People's Hospital of Yichang, Yichang, China.""}, {'ForeName': 'Ziqiu', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': ""Department of Urology, The Second People's Hospital of China Three Gorges University, The Second People's Hospital of Yichang, Yichang, China.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Du', 'Affiliation': ""Department of Urology, The Second People's Hospital of China Three Gorges University, The Second People's Hospital of Yichang, Yichang, China.""}]",Journal of endourology,['10.1089/end.2020.0564'] 1361,32940751,The effect of pre-operative high doses of methylprednisolone on pain management and convalescence after total hip replacement in elderly: a double-blind randomized study.,"PURPOSE The aim of the study was to assess whether administration of a single dose of methylprednisolone in the group patients above 65 years of age will be effective in complex analgesic management after total hip arthroplasty (THA). METHODS Seventy-seven patients above 65 years old were double-blind randomized into two: the study and controls groups. Pre-operatively, the study group received as a single dose of 125 mg intravenous methylprednisolone, while the others saline solution as placebo. Peri-operatively, all the patients were administered opioid and nonopioid analgesic agents. We measured the levels of inflammatory markers (leukocytosis, C-reactive protein-CRP), pain intensity level (visual analog scale-VAS; numerical rating scale-NRS), the life parameters, and noted complications. RESULTS Following administration of methylprednisolone were significantly lower levels of CRP on all the four post-operative days; leukocytosis on the second day; the VAS/NRS score at rest after six, 12, and 18 hours post-operatively, diminished the dose of parenteral opioid preparations (oxycodone hydrochloride), the duration of analgesia by peripheral nerve block was significantly higher as compared with the placebo group (p < 0.000001). No infectious complications were noted; there was one patient who developed post-operative delirium. CONCLUSION A single dose of methylprednisolone significantly reduces the level of post-operative pain at rest on the day of THA in the group patients above 65 years of age, decreases the dose of opioid analgesic agents, and significantly decreases the level of inflammatory markers, without infectious processes.",2021,"RESULTS Following administration of methylprednisolone were significantly lower levels of CRP on all the four post-operative days; leukocytosis on the second day; the VAS/NRS score at rest after six, 12, and 18 hours post-operatively, diminished the dose of parenteral opioid preparations (oxycodone hydrochloride), the duration of analgesia by peripheral nerve block was significantly higher as compared with the placebo group (p < 0.000001).","['group patients above 65\xa0years of age will be effective in complex analgesic management after total hip arthroplasty (THA', 'after total hip replacement in elderly', 'Seventy-seven patients above 65\xa0years old']","['saline solution as placebo', 'opioid and nonopioid analgesic agents', 'methylprednisolone', 'placebo', 'parenteral opioid preparations (oxycodone hydrochloride']","['infectious complications', 'level of post-operative pain', 'duration of analgesia by peripheral nerve block', 'levels of CRP', 'VAS/NRS score', 'level of inflammatory markers', 'pain management and convalescence', 'levels of inflammatory markers (leukocytosis, C-reactive protein-CRP), pain intensity level (visual analog scale-VAS; numerical rating scale-NRS), the life parameters, and noted complications']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0242937', 'cui_str': 'Non-opioid analgesic'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0282274', 'cui_str': 'Oxycodone hydrochloride'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0198807', 'cui_str': 'Peripheral block anesthesia'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0009940', 'cui_str': 'Convalescence'}, {'cui': 'C0023518', 'cui_str': 'Leukocytosis'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",77.0,0.250748,"RESULTS Following administration of methylprednisolone were significantly lower levels of CRP on all the four post-operative days; leukocytosis on the second day; the VAS/NRS score at rest after six, 12, and 18 hours post-operatively, diminished the dose of parenteral opioid preparations (oxycodone hydrochloride), the duration of analgesia by peripheral nerve block was significantly higher as compared with the placebo group (p < 0.000001).","[{'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Gądek', 'Affiliation': 'Department of Orthopedics and Physiotherapy, Jagiellonian University Collegium Medicum, Krakow, Poland.'}, {'ForeName': 'Henryk', 'Initials': 'H', 'LastName': 'Liszka', 'Affiliation': 'Department of Orthopedics and Traumatology, University Hospital in Krakow, Krakow, Poland. henryk.liszka@uj.edu.pl.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Zając', 'Affiliation': 'Department of Orthopedics and Traumatology, University Hospital in Krakow, Krakow, Poland.'}]",International orthopaedics,['10.1007/s00264-020-04802-8'] 1362,32943769,"Cognitive performance, mood and satiety following ingestion of beverages imparting different glycaemic responses: a randomised double-blind crossover trial.","BACKGROUND/OBJECTIVE The relationship between postprandial glycaemic responses and cognitive performance, mood and satiety are inconsistent. The objective of this study is to compare the effects of different glycaemic responses, induced by beverages with different glycaemic index (GI) (sucrose and isomaltulose), and a non-glycaemic control (sucralose), on cognition, mood and satiety. SUBJECTS/METHODS In this double-blinded, randomised crossover trial, healthy adults (n = 55) received sucrose (GI 65), isomaltulose (GI 32) and sucralose (non-caloric negative control) drinks on separate occasions. The Complex Figure test, the Word Recall test, Trail Making Test Part B and the Stroop test were administered 60 min after beverages ingestion. Mood and satiety were tested along with cognitive performance. RESULTS Comparing between isomaltulose and sucrose, there were no significant differences in the mean (95% CI) for the following: Complex Figure: immediate recall -0.6 (-1.7, 0.5), delayed recall -0.8 (-1.9, 0.3); Word recall: immediate recall 0.2 (-0.7, 1.1), delayed recall 0.5 (-0.4, 1.4); Trail Making: completing time -2.4 (-7.5, 2.7) s; Stroop: time used for correct congruent responses -9 (-31, 14) ms and correct incongruent responses -18 (-42, 6) ms. No differences among beverages were found in the mood and satiety scores with exception that participants felt more energetic 60 min after isomaltulose ingestion (p = 0.028 for difference with sucrose) and hungrier 30 min after isomaltulose ingestion (p = 0.036 for difference with sucrose; p = 0.022 for difference with sucralose). CONCLUSION Under these study conditions there is no convincing evidence for an effect of glycaemic response on cognitive performance, mood or satiety.",2021,"No differences among beverages were found in the mood and satiety scores with exception that participants felt more energetic 60 min after isomaltulose ingestion (p = 0.028 for difference with sucrose) and hungrier 30 min after isomaltulose ingestion (p = 0.036 for difference with sucrose; p = 0.022 for difference with sucralose). ",['healthy adults (n\u2009=\u200955) received'],"['beverages with different glycaemic index (GI) (sucrose and isomaltulose), and a non-glycaemic control (sucralose', 'sucrose (GI 65), isomaltulose (GI 32) and sucralose (non-caloric negative control) drinks']","['Mood and satiety', 'cognitive performance, mood or satiety', 'correct congruent responses -9 (-31, 14)\u2009ms and correct incongruent responses -18', 'postprandial glycaemic responses and cognitive performance, mood and satiety', 'Cognitive performance, mood and satiety following ingestion of beverages imparting different glycaemic responses', 'cognition, mood and satiety', 'mood and satiety scores']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0064002', 'cui_str': 'isomaltulose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0077046', 'cui_str': 'sucralose'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0439853', 'cui_str': 'Congruent'}, {'cui': 'C1321310', 'cui_str': 'Incongruous'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.415291,"No differences among beverages were found in the mood and satiety scores with exception that participants felt more energetic 60 min after isomaltulose ingestion (p = 0.028 for difference with sucrose) and hungrier 30 min after isomaltulose ingestion (p = 0.036 for difference with sucrose; p = 0.022 for difference with sucralose). ","[{'ForeName': 'Qingyuan', 'Initials': 'Q', 'LastName': 'Deng', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Jillian J', 'Initials': 'JJ', 'LastName': 'Haszard', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Tamlin S', 'Initials': 'TS', 'LastName': 'Conner', 'Affiliation': 'Department of Psychology, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Rapsey', 'Affiliation': 'Department of Psychological Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Peng', 'Affiliation': 'Department of Food Science, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Bernard J', 'Initials': 'BJ', 'LastName': 'Venn', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, New Zealand. bernard.venn@otago.ac.nz.'}]",European journal of clinical nutrition,['10.1038/s41430-020-00749-6'] 1363,32940718,The additional role of virtual to traditional dissection in teaching anatomy: a randomised controlled trial.,"INTRODUCTION Anatomy has traditionally been taught via dissection and didactic lectures. The rising prevalence of informatics plays an increasingly important role in medical education. It is hypothesized that virtual dissection can express added value to the traditional one. METHODS Second-year medical students were randomised to study anatomical structures by virtual dissection (intervention) or textbooks (controls), according to the CONSORT guidelines. Subsequently, they applied to the corresponding gross dissection, with a final test on their anatomical knowledge. Univariate analysis and multivariable binary logistic regression were performed. RESULTS The rate of completed tests was 76.7%. Better overall test performance was detected for the group that applied to the virtual dissection (OR 3.75 with 95% CI 0.91-15.49; p = 0.06). A comparable performance between groups in basic anatomical knowledge (p 0.45 to 0.92) but not muscles and 2D-3D reporting of anatomical structures was found, for which the virtual dissection was of tendential benefit (p 0.08 to 0.13). Medical students who applied to the virtual dissection were over three times more likely to report a positive outcome at the post-dissection test than those who applied to textbooks of topographical anatomy. This would be of benefit with particular reference to the understanding of 2D-3D spatial relationships between anatomical structures. CONCLUSION The combination of virtual to traditional gross dissection resulted in a significant improvement of second-year medical students' learning outcomes. It could be of help in maximizing the impact of practical dissection, overcoming the contraction of economic resources, and the shortage of available bodies.",2021,"A comparable performance between groups in basic anatomical knowledge (p 0.45 to 0.92) but not muscles and 2D-3D reporting of anatomical structures was found, for which the virtual dissection was of tendential benefit (p 0.08 to 0.13).",['Second-year medical students'],"['virtual dissection (intervention) or textbooks (controls), according to the CONSORT guidelines']",['Better overall test performance'],"[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C0039712', 'cui_str': 'Textbooks'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0266685,"A comparable performance between groups in basic anatomical knowledge (p 0.45 to 0.92) but not muscles and 2D-3D reporting of anatomical structures was found, for which the virtual dissection was of tendential benefit (p 0.08 to 0.13).","[{'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Boscolo-Berto', 'Affiliation': 'Department of Neurosciences, Institute of Human Anatomy, University of Padova, Via Gabelli 65, Padova, Italy.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Tortorella', 'Affiliation': 'Department of Neurosciences, Institute of Human Anatomy, University of Padova, Via Gabelli 65, Padova, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Porzionato', 'Affiliation': 'Department of Neurosciences, Institute of Human Anatomy, University of Padova, Via Gabelli 65, Padova, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Stecco', 'Affiliation': 'Department of Neurosciences, Institute of Human Anatomy, University of Padova, Via Gabelli 65, Padova, Italy.'}, {'ForeName': 'Edgardo Enrico Edoardo', 'Initials': 'EEE', 'LastName': 'Picardi', 'Affiliation': 'Digestive System Surgery Division, European Institute of Oncology (IRCSS), Via Ripamonti 435, Milano, Italy.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Macchi', 'Affiliation': 'Department of Neurosciences, Institute of Human Anatomy, University of Padova, Via Gabelli 65, Padova, Italy. veronica.macchi@unipd.it.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'De Caro', 'Affiliation': 'Department of Neurosciences, Institute of Human Anatomy, University of Padova, Via Gabelli 65, Padova, Italy.'}]",Surgical and radiologic anatomy : SRA,['10.1007/s00276-020-02551-2'] 1364,32935261,Sleep problems in preschool-onset major depressive disorder: the effect of treatment with parent-child interaction therapy-emotion development.,"In school-aged children, adolescents, and adults, more than 72% of individuals diagnosed with major depression report co-occurring sleep problems, but little is known about sleep problems in the context of preschool-onset major depressive disorder (PO-MDD). The current study examined the prevalence of various sleep problems in a sample of young children diagnosed with PO-MDD and explored how the treatment of depression, using a modification of parent-child interaction therapy focused on emotional development (PCIT-ED), affects sleep problems. Participants included 229 preschoolers (ages 3-6 years) who met criteria for PO-MDD and participated a single-blind, randomized control trial comparing PCIT-ED to a waitlist control condition. Children were randomly assigned to either PCIT-ED (n = 114) or the waitlist condition (n = 115). Children were assessed at baseline, immediately after PCIT-ED, and 3 months after treatment completion for parent-reported sleep problems across the domains of insomnia, hypersomnia, daytime fatigue, and a total sleep problem index. In our sample, 45% of children had at least one subthreshold sleep problem, 38.4% had at least one threshold sleep problem, and 72.5% had at least one sleep problem (either threshold or subthreshold). Treatment with PCIT-ED significantly reduced sleep problems, including insomnia, daytime fatigue, and total sleep problems, compared to a waitlist condition, even when controlling for child depression. This reduction was maintained at a 3-month follow-up. Sleep problems are a prevalent co-occurring condition with PO-MDD. Interventions such as PCIT-ED that also effectively reduce sleep problems may be particularly beneficial for recovery from PO-MDD.Clinical trial registration information: a randomized control trial of PCIT-ED for preschool depression; https://clinicaltrials.gov/NCT02076425 .",2020,"Treatment with PCIT-ED significantly reduced sleep problems, including insomnia, daytime fatigue, and total sleep problems, compared to a waitlist condition, even when controlling for child depression.","['young children diagnosed with PO-MDD', 'school-aged children, adolescents, and adults, more than 72% of individuals diagnosed with major depression report co-occurring sleep problems', 'Participants included 229 preschoolers (ages 3-6\xa0years) who met criteria for PO-MDD and participated a single-blind', 'preschool-onset major depressive disorder']","['PCIT-ED', 'parent-child interaction therapy-emotion development']","['sleep problems across the domains of insomnia, hypersomnia, daytime fatigue, and a total sleep problem index', 'Sleep problems', 'reduced sleep problems, including insomnia, daytime fatigue, and total sleep problems', 'subthreshold sleep problem']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0242570', 'cui_str': 'Single-Masked Study'}]","[{'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]","[{'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0917799', 'cui_str': 'Hypersomnia'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",229.0,0.109005,"Treatment with PCIT-ED significantly reduced sleep problems, including insomnia, daytime fatigue, and total sleep problems, compared to a waitlist condition, even when controlling for child depression.","[{'ForeName': 'Caroline P', 'Initials': 'CP', 'LastName': 'Hoyniak', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, 4444 Forest Park Avenue, St. Louis, MO, 63108, USA. choyniak@wustl.edu.'}, {'ForeName': 'Diana J', 'Initials': 'DJ', 'LastName': 'Whalen', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, 4444 Forest Park Avenue, St. Louis, MO, 63108, USA.'}, {'ForeName': 'Deanna', 'Initials': 'D', 'LastName': 'Barch', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, 4444 Forest Park Avenue, St. Louis, MO, 63108, USA.'}, {'ForeName': 'Joan L', 'Initials': 'JL', 'LastName': 'Luby', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, 4444 Forest Park Avenue, St. Louis, MO, 63108, USA.'}]",European child & adolescent psychiatry,['10.1007/s00787-020-01641-1'] 1365,32935270,A Multicenter Randomized Prospective Study of Early Cholecystectomy for Pediatric Patients with Biliary Colic.,"BACKGROUND In patients with biliary colic, high-quality prospective data supporting the precise timing of cholecystectomy are lacking. The purpose of this study was to determine the effectiveness of early laparoscopic cholecystectomy in children with biliary colic. METHODS A multicenter, parallel-group, randomized study was conducted in patients with biliary colic at 5 hospitals in China. Pediatric patients with biliary colic were prospectively randomized to either the early cholecystectomy or conservative management strategy. The clinical outcomes within 6 months, including the number of biliary colic-free patients and gallstone-related complications, were compared (register number ChiCTR1900021830). RESULTS During the first 2 months of follow-up, 71 patients (59.2%, 71/120) receiving conservative management and 124 patients (97.6%, 124/127) in the early cholecystectomy group (p < 0.001) reported being entirely colic-free. The GIQLI measures were higher in the early cholecystectomy group than in the conservative management group (p = 0.032). Acute readmissions occurred in 7 (5.5%) of 127 patients in the early cholecystectomy group, compared with 23 (19.2%) of 120 patients in the conservative management group (risk ratio [RR] 0.25; 95% CI [0.10-0.60], p = 0.001) in the 6-month period. CONCLUSIONS Early cholecystectomy is effective in providing beneficial outcomes in terms of both short-term and long-term improvement of symptoms.",2021,Early cholecystectomy is effective in providing beneficial outcomes in terms of both short-term and long-term improvement of symptoms.,"['patients with biliary colic', 'patients with biliary colic at 5 hospitals in China', 'Pediatric patients with biliary colic', 'Pediatric Patients with Biliary Colic', 'children with biliary colic', 'A multicenter']","['laparoscopic cholecystectomy', 'Early Cholecystectomy', 'early cholecystectomy or conservative management strategy']","['number of biliary colic-free patients and gallstone-related complications', 'Acute readmissions', 'GIQLI measures']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0151824', 'cui_str': 'Biliary colic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0151824', 'cui_str': 'Biliary colic'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008350', 'cui_str': 'Biliary calculus'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0970884,Early cholecystectomy is effective in providing beneficial outcomes in terms of both short-term and long-term improvement of symptoms.,"[{'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Gao', 'Affiliation': ""Department of Pediatric General Surgery and Liver Transplantation, Children's Hospital, Chongqing Medical University, 136 Zhongshan 2nd Rd., Chongqing, 400014, People's Republic of China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': ""Department of Orthopedics, Children's Hospital, Chongqing Medical University, Chongqing, 400014, People's Republic of China.""}, {'ForeName': 'Huanli', 'Initials': 'H', 'LastName': 'Han', 'Affiliation': ""Department of Pediatric General Surgery and Liver Transplantation, Children's Hospital, Chongqing Medical University, 136 Zhongshan 2nd Rd., Chongqing, 400014, People's Republic of China. guochunbao@cqmu.edu.cn.""}, {'ForeName': 'Chunbao', 'Initials': 'C', 'LastName': 'Guo', 'Affiliation': ""Department of Pediatric General Surgery and Liver Transplantation, Children's Hospital, Chongqing Medical University, 136 Zhongshan 2nd Rd., Chongqing, 400014, People's Republic of China. guochunbao@cqmu.edu.cn.""}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-020-04700-9'] 1366,32935287,Open-Label Assessment of the Effects of Itraconazole and Rifampicin on Balovaptan Pharmacokinetics in Healthy Volunteers.,"INTRODUCTION Balovaptan, an investigational vasopressin 1a receptor antagonist that has been evaluated for improvement of social communication and interaction, is primarily metabolized by cytochrome P450 3A4 (CYP3A4). METHODS Two single-center, non-randomized, two-period, phase 1 studies assessed the effect of the strong CYP3A4 inhibitor itraconazole (study NCT03579719) or the strong CYP3A4 inducer rifampicin (study NCT03586726) at steady state on the pharmacokinetics (PK) of steady-state balovaptan in healthy volunteers. Participants received balovaptan (5 or 10 mg/day) alone for 10 days, or in combination with itraconazole (200 mg/day) for 15 days, or rifampicin (600 mg/day) for 10 days, following balovaptan washout and itraconazole/rifampicin pre-dosing. Geometric mean ratios (GMRs) and 90% confidence intervals (90% CIs) for the area under the concentration-time curve over the dosing interval (AUC) and maximum plasma concentration (C max ) of balovaptan dosed with vs. without itraconazole/rifampicin were estimated from a mixed effects model. RESULTS Both studies comprised 15-16 healthy male and female volunteers. Itraconazole 200 mg/day elevated steady-state exposure to 5 mg/day balovaptan approximately 4.5-5.5-fold (Day 15 GMR [90% CI], 4.46 [4.06-4.90] for C max and 5.57 [5.00-6.21] for AUC) and extended the time to steady state from ~ 5 days to ~ 13-14 days. Rifampicin 600 mg/day resulted in ~ 90% reductions in both the C max (Day 10 GMR [90% CI], 0.14 [0.12-0.15]) and AUC (0.07 [0.06-0.07]) of balovaptan 10 mg/day. Time to balovaptan steady state could not be determined with rifampicin. There were no clinically significant safety findings in either study. CONCLUSIONS Strong modulators of CYP3A4 activity will significantly alter the PK of balovaptan, with the effect of CYP3A4 induction greater than that of inhibition. Caution should be taken when concomitantly dosing balovaptan with moderate or strong CYP3A4 inducers or strong CYP3A4 inhibitors. TRIAL REGISTRATION NUMBER NCT03579719; NCT03586726.",2020,"(Day 15 GMR [90% CI], 4.46 [4.06-4.90] for C max and 5.57 [5.00-6.21] for AUC) and extended the time to steady state from ~ ","['Healthy Volunteers', 'healthy volunteers', '15-16 healthy male and female volunteers']","['Rifampicin', 'Itraconazole 200\xa0mg/day elevated steady-state exposure to 5', 'itraconazole/rifampicin', 'balovaptan washout and itraconazole/rifampicin pre-dosing', 'strong CYP3A4 inhibitor itraconazole (study NCT03579719) or the strong CYP3A4 inducer rifampicin (study NCT03586726) at steady state on the pharmacokinetics (PK) of steady-state balovaptan', 'balovaptan (5 or 10\xa0mg/day) alone for 10\xa0days, or in combination with itraconazole', 'rifampicin', 'Itraconazole and Rifampicin']","['Balovaptan Pharmacokinetics', 'Geometric mean ratios (GMRs', 'time to steady state from\u2009', 'concentration-time curve over the dosing interval (AUC) and maximum plasma concentration (C max ']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C2917463', 'cui_str': 'Itraconazole 200 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0439565', 'cui_str': 'Pre-dose'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C1142644', 'cui_str': 'cytochrome P450 3A4 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",,0.036334,"(Day 15 GMR [90% CI], 4.46 [4.06-4.90] for C max and 5.57 [5.00-6.21] for AUC) and extended the time to steady state from ~ ","[{'ForeName': 'Michael G M', 'Initials': 'MGM', 'LastName': 'Derks', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, UK. michael.derks@roche.com.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wandel', 'Affiliation': 'F. Hoffmann-La Roche AG, Basel, Switzerland.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Young', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'Stuart K', 'Initials': 'SK', 'LastName': 'Bolt', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Meyenberg', 'Affiliation': 'F. Hoffmann-La Roche AG, Basel, Switzerland.'}]",Advances in therapy,['10.1007/s12325-020-01491-y'] 1367,32938772,Premature permanent discontinuation of apixaban or warfarin in patients with atrial fibrillation.,"AIMS The ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) trial randomised patients with atrial fibrillation at risk of stroke to apixaban or warfarin. We sought to describe patients from ARISTOTLE who prematurely permanently discontinued study drug. METHODS/RESULTS We performed a posthoc analysis of patients from ARISTOTLE who prematurely permanently discontinued study drug during the study or follow-up period. Discontinuation rates and reasons for discontinuation were described. Death, thromboembolism (stroke, transient ischaemic attack, systemic embolism), myocardial infarction and major bleeding rates were stratified by ≤30 days or >30 days after discontinuation. A total of 4063/18 140 (22.4%) patients discontinued study drug at a median of 7.3 (2.2, 15.2) months after randomisation. Patients with discontinuation were more likely to be female and had a higher prevalence of cardiovascular disease, diabetes, renal impairment and anaemia. Premature permanent discontinuation was more common in those randomised to warfarin than apixaban (23.4% vs 21.4%; p=0.002). The most common reasons for discontinuation were patient request (46.1%) and adverse event (34.9%), with no significant difference between treatment groups. The cumulative incidence of clinical events ≤30 days after premature permanent discontinuation for all-cause death, thromboembolism, myocardial infarction, and major bleeding was 5.8%, 2.6%, 0.9%, and 3.0%, respectively. No significant difference was seen between treatment groups with respect to clinical outcomes after discontinuation. CONCLUSION Premature permanent discontinuation of study drug in ARISTOTLE was common, less frequent in patients receiving apixaban than warfarin and was followed by high 30-day rates of death, thromboembolism and major bleeding. Initiatives are needed to reduce discontinuation of oral anticoagulation.",2021,"Death, thromboembolism (stroke, transient ischaemic attack, systemic embolism), myocardial infarction and major bleeding rates were stratified by ≤30 days or >30 days after discontinuation.","['patients from ARISTOTLE who prematurely permanently discontinued study drug during the study or follow-up period', 'patients from ARISTOTLE who prematurely permanently discontinued study drug', 'A total of 4063/18 140 (22.4%) patients discontinued study drug at a median of 7.3 (2.2, 15.2) months after randomisation', 'patients with atrial fibrillation', 'Atrial Fibrillation) trial randomised patients with atrial fibrillation at risk of stroke to apixaban or warfarin']","['warfarin', 'apixaban or warfarin']","['Discontinuation rates and reasons for discontinuation', 'Death, thromboembolism (stroke, transient ischaemic attack, systemic embolism), myocardial infarction and major bleeding rates', 'cardiovascular disease, diabetes, renal impairment and anaemia', '30-day rates of death, thromboembolism and major bleeding', 'Premature permanent discontinuation', 'death, thromboembolism, myocardial infarction, and major bleeding', 'adverse event']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}]","[{'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.100854,"Death, thromboembolism (stroke, transient ischaemic attack, systemic embolism), myocardial infarction and major bleeding rates were stratified by ≤30 days or >30 days after discontinuation.","[{'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Carnicelli', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Sana M', 'Initials': 'SM', 'LastName': 'Al-Khatib', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Xavier', 'Affiliation': ""St John's Medical College, Bangalore, Karnataka, India.""}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Dalgaard', 'Affiliation': 'Cardiology, Gentofte Hospital, Hellerup, Hovedstaden, Denmark.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Merrill', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Wojdyla', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Basil S', 'Initials': 'BS', 'LastName': 'Lewis', 'Affiliation': 'Lady Davies Carmel Medical Center, Haifa, Israel.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hanna', 'Affiliation': 'Bristol-Myers Squibb Pharmaceutical Research and Development, Princeton, New Jersey, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Wallentin', 'Affiliation': 'Uppsala Clinical Research Center, University of Uppsala, Uppsala, Sweden.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA christopher.granger@duke.edu.'}]",Heart (British Cardiac Society),['10.1136/heartjnl-2020-317229'] 1368,32941737,Prior ingestion of a ketone monoester supplement reduces postprandial glycemic responses in young healthy-weight individuals.,"The main objective of this study was to determine whether acute ingestion of a ketone monoester (KME) supplement impacted mixed-meal tolerance test (MMTT) glucose area under the curve (AUC). Nineteen healthy young volunteers (10 males/9 females; age, 24.7 ± 4.9 years; body mass index, 22.7 ± 2.4 kg/m 2 ) participated in a double-blind, placebo-controlled crossover study. Following overnight fasting (≥10 h), participants consumed 0.45 mL/kg of a KME supplement or taste-matched placebo followed by an MMTT 15 min later. Blood samples were collected every 15-30 min over 2.5 h. KME supplementation acutely raised β-hydroxybutyrate AUC (590%, P < 0.0001, d = 2.4) and resulted in decreases in blood glucose AUC (-9.4%, P = 0.03, d = 0.56) and nonesterified fatty acid (NEFA) AUC (-27.3%, P = 0.023, d = 0.68) compared with placebo. No differences were found for plasma insulin AUC ( P = 0.70) or gastric emptying estimated by co-ingested acetaminophen AUC ( P = 0.96) between ketone and placebo. Overall, results indicate that KME supplementation attenuates postprandial glycemic and NEFA responses when taken 15 min prior to a mixed meal in young healthy individuals. Future studies are warranted to investigate whether KME supplementation may benefit individuals with impaired glycemic control. Novelty: Acute ketone monoester supplementation 15 min prior to a mixed meal decreased postprandial glucose and NEFA levels without significantly impacting postprandial insulin or estimates of gastric emptying. Glucose- and NEFA-lowering effects of ketone monoester supplementation are apparently not mediated by changes in insulin release or gastric emptying.",2021,"KME supplementation acutely raised beta-hydroxybutyrate (β-OHB) AUC (590%, P < 0.0001, d = 2.4) and resulted in decreases in blood glucose AUC (-9.4%, P = 0.03, d = 0.56) and non-esterified fatty acid (NEFA) AUC (-27.3%, P = 0.023, d = 0.68) compared to placebo.","['Nineteen healthy young volunteers (10 males/9 females, 24.7 ± 4.9 years, BMI = 22.7 ± 2.4) participated in a double-blind', 'young healthy individuals']","['KME supplement or taste-matched placebo', 'placebo', 'KME supplementation', 'ketone monoester (KME']","['postprandial glycemic and NEFA responses', 'Novelty Bullets •', 'blood glucose AUC', 'mixed meal tolerance test (MMTT) glucose area under the curve (AUC', 'Blood samples', 'plasma insulin AUC', 'gastric emptying', 'postprandial glucose and non-esterified fatty acid (NEFA) levels', 'non-esterified fatty acid (NEFA) AUC', 'insulin release or gastric emptying', 'KME supplementation acutely raised beta-hydroxybutyrate (β-OHB) AUC']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0369212', 'cui_str': 'Esterified fatty acid'}, {'cui': 'C0336699', 'cui_str': 'Bullet'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0201777', 'cui_str': 'Tolerance test'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0106006', 'cui_str': '3-hydroxybutyrate'}, {'cui': 'C0036071', 'cui_str': 'salicylamide'}]",19.0,0.104255,"KME supplementation acutely raised beta-hydroxybutyrate (β-OHB) AUC (590%, P < 0.0001, d = 2.4) and resulted in decreases in blood glucose AUC (-9.4%, P = 0.03, d = 0.56) and non-esterified fatty acid (NEFA) AUC (-27.3%, P = 0.023, d = 0.68) compared to placebo.","[{'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Greaves', 'Affiliation': 'Faculty of Medicine, The University of British Columbia, Okanagan Campus, Kelowna, BC V1V 1V7, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Xiang', 'Affiliation': 'Faculty of Medicine, The University of British Columbia, Okanagan Campus, Kelowna, BC V1V 1V7, Canada.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Rafiei', 'Affiliation': 'School of Health and Exercise Sciences, The University of British Columbia, Okanagan Campus, Kelowna, BC V1V 1V7, Canada.'}, {'ForeName': 'Adeeb', 'Initials': 'A', 'LastName': 'Malas', 'Affiliation': 'Faculty of Medicine, The University of British Columbia, Okanagan Campus, Kelowna, BC V1V 1V7, Canada.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Little', 'Affiliation': 'School of Health and Exercise Sciences, The University of British Columbia, Okanagan Campus, Kelowna, BC V1V 1V7, Canada.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2020-0644'] 1369,32943128,Increasing dietary fibre intake in healthy adults using personalised dietary advice compared with general advice: a single-blind randomised controlled trial.,"OBJECTIVE A high-fibre diet is associated with a lower risk for diseases. However, few adults meet the dietary fibre recommendation. Therefore, the effects and acceptance of an algorithm-generated personalised dietary advice (PDA) compared with general advice (GA) on fibre intake were investigated. DESIGN A 6-week, single-blind randomised controlled trial with a 3-month follow-up. SETTING PDA was based on habitual intake and provided fibre-rich alternatives using a website; GA contained brochures. Dietary intake was assessed at baseline, week 1, week 6 and 3-month follow-up. Both groups evaluated their advice at week 6. All participants had access to PDA from week 7 until 3-month follow-up. PARTICIPANTS Two groups of healthy adults: PDA (n 34) and GA (n 47). For 3-month follow-up analysis, participants were re-divided into visitors (n 52) and non-visitors (n 26) of the PDA. RESULTS At week 6, energy intake remained stable in both groups, but fibre intake per 1000 kcal increased non-significantly in both groups (PDA = Δ0·5 ± 2·8; GA = Δ0·8 ± 3·1, P = 0·128). Importantly, a significantly higher percentage of PDA participants adhered to the recommendation compared with week 1 (PDA = 21 % increase; GA = 4 % increase, P ≤ 0·001). PDA participants evaluated the advice significantly better compared with GA participants. At 3-month follow-up, fibre intake increased compared with baseline (visitors = Δ2·2 ± 2·6, P < 0·001; non-visitors = Δ1·5 ± 1·9, P = 0·001), but was insignificantly different between groups. Visitors had a decrease and non-visitors had an increase in energy intake (visitors =Δ - 132 ± 525; non-visitors = Δ109 ± 507, P = 0·055). CONCLUSIONS The algorithm-generated PDA was well accepted and stimulated adherence to the recommendations more than GA, indicating to be a suitable and cost-efficient method for improving dietary fibre intake in healthy adults.",2021,"At week 6, energy intake remained stable in both groups, but fibre intake per 1000 kcal increased non-significantly in both groups (PDA = Δ0·5 ± 2·8; GA = Δ0·8 ± 3·1, P = 0·128).","['participants were re-divided into visitors (n 52) and non-visitors (n 26) of the PDA', 'Two groups of healthy adults: PDA (n 34) and GA (n 47', 'healthy adults']","['personalised dietary advice', 'algorithm-generated personalised dietary advice (PDA', 'PDA', 'general advice (GA']","['fibre intake', 'Dietary intake', 'fibre intake per 1000 kcal increased non', 'energy intake']","[{'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",,0.0631735,"At week 6, energy intake remained stable in both groups, but fibre intake per 1000 kcal increased non-significantly in both groups (PDA = Δ0·5 ± 2·8; GA = Δ0·8 ± 3·1, P = 0·128).","[{'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Rijnaarts', 'Affiliation': 'Division of Human Nutrition & Health, Wageningen University & Research, Stippeneng 4, 6708 WE Wageningen, the Netherlands.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'de Roos', 'Affiliation': 'Division of Human Nutrition & Health, Wageningen University & Research, Stippeneng 4, 6708 WE Wageningen, the Netherlands.'}, {'ForeName': 'Taojun', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Laboratory of Microbiology, Wageningen University & Research, Wageningen, the Netherlands.'}, {'ForeName': 'Erwin G', 'Initials': 'EG', 'LastName': 'Zoetendal', 'Affiliation': 'Laboratory of Microbiology, Wageningen University & Research, Wageningen, the Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Top', 'Affiliation': 'Wageningen Food and Biobased Research, Wageningen University & Research, Wageningen, the Netherlands.'}, {'ForeName': 'Marielle', 'Initials': 'M', 'LastName': 'Timmer', 'Affiliation': 'Wageningen Food and Biobased Research, Wageningen University & Research, Wageningen, the Netherlands.'}, {'ForeName': 'Emily P', 'Initials': 'EP', 'LastName': 'Bouwman', 'Affiliation': 'Wageningen Economic Research, Wageningen University & Research, Wageningen, the Netherlands.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Hogenelst', 'Affiliation': 'Department of Training and Performance Innovations, The Netherlands Organization for Applied Scientific Research (TNO), Soesterberg, the Netherlands.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Witteman', 'Affiliation': 'Division of Human Nutrition & Health, Wageningen University & Research, Stippeneng 4, 6708 WE Wageningen, the Netherlands.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'de Wit', 'Affiliation': 'Wageningen Food and Biobased Research, Wageningen University & Research, Wageningen, the Netherlands.'}]",Public health nutrition,['10.1017/S1368980020002980'] 1370,32941336,Comparison of Pneumatonometry and Transpalpebral Tonometry Measurements of Intraocular Pressure during Scleral Lens Wear.,"SIGNIFICANCE As scleral lens wear becomes more common, understanding the impact of these lenses upon ocular physiology is critically important. Studies on the effect of scleral lens wear upon intraocular pressure (IOP) have used different instruments and have reported conflicting results. PURPOSE The purpose of this study was to compare assessment of IOP during scleral lens wear using pneumatonometry and transpalpebral tonometry. METHODS Twenty healthy subjects wore a small-diameter (15.2 mm) and a large-diameter (18.0 mm) scleral lens on the right eye, each for 1 hour in randomized order. IOP was assessed with pneumatonometry and transpalpebral tonometry on both eyes before lens application, immediately after lens application, after 1 hour of lens wear, and immediately after lens removal. Paired t test compared mean IOP in the study eye to the control eye. Repeated-measures ANOVA was performed to take instrumentation, lens diameter, and their interaction into account in an analysis of the change in IOP in the study eye. RESULTS Mean peripheral IOP measured with pneumatonometry was not significantly different from baseline at any subsequent measurement. Measurements with transpalpebral tonometry, however, were significantly different during scleral lens wear immediately after application and after 1 hour of wear with both diameter lenses (P < .005), but were not significantly different after either sized lens was removed. Repeated-measures ANOVA revealed that the instrument used to measure IOP was a significant factor in IOP changes found during lens wear (P ≤ .001). CONCLUSIONS Assessment of IOP during scleral lens wear varies based upon the instrument that is used. Although further studies are clearly needed to further elucidate this issue, clinicians should continue to monitor optic nerve structure and function in scleral lens wearers, as they do in all patients.",2020,"Repeated-measures ANOVA revealed that the instrument used to measure IOP was a significant factor in IOP changes found during lens wear (P ≤ .001). ","['Intraocular Pressure during Scleral Lens Wear', 'Twenty healthy subjects wore a small-diameter (15.2 mm) and a large-diameter (18.0 mm) scleral lens on the right eye, each for 1 hour in randomized order']","['scleral lens wear upon intraocular pressure (IOP', 'Pneumatonometry and Transpalpebral Tonometry Measurements', 'pneumatonometry and transpalpebral tonometry']","['Mean peripheral IOP', 'IOP', 'IOP changes']","[{'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0229089', 'cui_str': 'Right eye structure'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4284072', 'cui_str': 'Order document'}]","[{'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0040420', 'cui_str': 'Tonometry'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",20.0,0.042258,"Repeated-measures ANOVA revealed that the instrument used to measure IOP was a significant factor in IOP changes found during lens wear (P ≤ .001). ","[{'ForeName': 'Jennifer Swingle', 'Initials': 'JS', 'LastName': 'Fogt', 'Affiliation': 'The Ohio State University, College of Optometry, Columbus, Ohio.'}, {'ForeName': 'Cherie B', 'Initials': 'CB', 'LastName': 'Nau', 'Affiliation': 'Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Schornack', 'Affiliation': 'Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Shorter', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Nau', 'Affiliation': 'Korb & Associates, Boston, Massachusetts.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Harthan', 'Affiliation': 'Illinois College of Optometry, Chicago, Illinois.'}]",Optometry and vision science : official publication of the American Academy of Optometry,['10.1097/OPX.0000000000001574'] 1371,32947595,Cost-Effectiveness of Volar Locking Plate Compared with Augmented External Fixation for Displaced Intra-Articular Wrist Fractures.,"BACKGROUND The purpose of the present study was to estimate the cost-effectiveness of treating displaced, intra-articular distal radial fractures with volar locking plate fixation compared with augmented external fixation. METHODS A cost-utility analysis was conducted alongside a randomized, clinical trial comparing 2 surgical interventions for intra-articular distal radial fractures. One hundred and sixty-six patients were allocated to either volar locking plate fixation (84 patients) or external fixation (82 patients) and were followed for 2 years. Health-related quality of life was assessed with the EuroQol-5 Dimensions and was used to calculate patients' quality-adjusted life-years (QALYs). Resource use was identified prospectively at the patient level at all follow-up intervals. Costs were estimated with use of both a health-care perspective and a societal perspective. Results were expressed in incremental cost-effectiveness ratios, and uncertainty was assessed with use of bootstrapping methods. RESULTS The average QALY value was equivalent between the groups (1.70463 for the volar locking plate group and 1.70726 for the external fixation group, yielding a nonsignificant difference of -0.00263 QALY). Health-care costs were equal between the groups, with a nonsignificant difference of &OV0556;52 (p = 0.8) in favor of external fixation. However, the external fixation group had a higher loss of productivity due to absence from work (5.5 weeks in the volar locking plate group compared with 9.2 weeks for the external fixation group; p = 0.02). Consequently, the societal costs were higher for the external fixation group compared with the volar locking plate group (&OV0556;18,037 compared with &OV0556;12,567, representing a difference of &OV0556;5,470; p = 0.04) in favor of the volar locking plate group. Uncertainty analyses showed that there is indifference regarding which method to recommend from a health-care perspective, with volar locking plate treatment and external fixation having a 47% and 53% likelihood of being cost-effective, respectively. From the societal perspective, volar locking plate treatment had a 90% likelihood of being cost-effective. CONCLUSIONS External fixation was less cost-effective than volar locking plate treatment for distal radial fractures from a societal perspective, primarily because patients managed with external fixation had a longer absence from work. LEVEL OF EVIDENCE Economic and Decision Analysis Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"CONCLUSIONS External fixation was less cost-effective than volar locking plate treatment for distal radial fractures from a societal perspective, primarily because patients managed with external fixation had a longer absence from work. ","['Displaced Intra-Articular Wrist Fractures', 'intra-articular distal radial fractures', 'One hundred and sixty-six patients']","['External fixation', 'volar locking plate fixation (84 patients) or external fixation', 'volar locking plate', 'volar locking plate fixation compared with augmented external fixation', 'Volar Locking Plate Compared with Augmented External Fixation', 'volar locking plate treatment']","['cost-effectiveness', 'Cost-Effectiveness', 'Health-care costs', 'societal costs', 'Health-related quality of life', 'cost-effective', 'incremental cost-effectiveness ratios, and uncertainty', 'average QALY value']","[{'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0435630', 'cui_str': 'Fracture of distal end of radius and ulna'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0034628', 'cui_str': 'Fracture of radius'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0407333', 'cui_str': 'External skeletal fixation procedure'}, {'cui': 'C0443349', 'cui_str': 'Volar'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",166.0,0.0457825,"CONCLUSIONS External fixation was less cost-effective than volar locking plate treatment for distal radial fractures from a societal perspective, primarily because patients managed with external fixation had a longer absence from work. ","[{'ForeName': 'Ola-Lars', 'Initials': 'OL', 'LastName': 'Hammer', 'Affiliation': 'Akershus University Hospital, Akershus, Norway.'}, {'ForeName': 'Rune Bruhn', 'Initials': 'RB', 'LastName': 'Jakobsen', 'Affiliation': 'Akershus University Hospital, Akershus, Norway.'}, {'ForeName': 'Stale', 'Initials': 'S', 'LastName': 'Clementsen', 'Affiliation': 'Akershus University Hospital, Akershus, Norway.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Fuglesang', 'Affiliation': 'Akershus University Hospital, Akershus, Norway.'}, {'ForeName': 'Gudrun Waaler', 'Initials': 'GW', 'LastName': 'Bjornelv', 'Affiliation': 'University of Oslo, Oslo, Norway.'}, {'ForeName': 'Per-Henrik', 'Initials': 'PH', 'LastName': 'Randsborg', 'Affiliation': 'Akershus University Hospital, Akershus, Norway.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.01288'] 1372,32955293,"Big smile, small self: Awe walks promote prosocial positive emotions in older adults.","Aging into later life is often accompanied by social disconnection, anxiety, and sadness. Negative emotions are self-focused states with detrimental effects on aging and longevity. Awe-a positive emotion elicited when in the presence of vast things not immediately understood-reduces self-focus, promotes social connection, and fosters prosocial actions by encouraging a ""small self."" We investigated the emotional benefits of a novel ""awe walk"" intervention in healthy older adults. Sixty participants took weekly 15-min outdoor walks for 8 weeks; participants were randomly assigned to an awe walk group, which oriented them to experience awe during their walks, or to a control walk group. Participants took photographs of themselves during each walk and rated their emotional experience. Each day, they reported on their daily emotional experience outside of the walk context. Participants also completed pre- and postintervention measures of anxiety, depression, and life satisfaction. Compared with participants who took control walks, those who took awe walks experienced greater awe during their walks and exhibited an increasingly ""small self"" in their photographs over time. They reported greater joy and prosocial positive emotions during their walks and displayed increasing smile intensity over the study. Outside of the walk context, participants who took awe walks reported greater increases in daily prosocial positive emotions and greater decreases in daily distress over time. Postintervention anxiety, depression, and life satisfaction did not change from baseline in either group. These results suggest cultivating awe enhances positive emotions that foster social connection and diminishes negative emotions that hasten decline. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Postintervention anxiety, depression, and life satisfaction did not change from baseline in either group.","['Big smile, small self', 'older adults', 'Sixty participants took weekly 15-min outdoor walks for 8 weeks; participants', 'healthy older adults']","['control walk group', 'novel ""awe walk"" intervention']","['daily prosocial positive emotions', 'anxiety, depression, and life satisfaction', 'prosocial positive emotions', 'joy and prosocial positive emotions', 'daily distress', 'Postintervention anxiety, depression, and life satisfaction', 'smile intensity']","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0037363', 'cui_str': 'Smiling'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0037363', 'cui_str': 'Smiling'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",60.0,0.0671627,"Postintervention anxiety, depression, and life satisfaction did not change from baseline in either group.","[{'ForeName': 'Virginia E', 'Initials': 'VE', 'LastName': 'Sturm', 'Affiliation': 'Department of Neurology, University of California, San Francisco.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Datta', 'Affiliation': 'Department of Neurology, University of California, San Francisco.'}, {'ForeName': 'Ashlin R K', 'Initials': 'ARK', 'LastName': 'Roy', 'Affiliation': 'Department of Neurology, University of California, San Francisco.'}, {'ForeName': 'Isabel J', 'Initials': 'IJ', 'LastName': 'Sible', 'Affiliation': 'Department of Neurology, University of California, San Francisco.'}, {'ForeName': 'Eena L', 'Initials': 'EL', 'LastName': 'Kosik', 'Affiliation': 'Department of Neurology, University of California, San Francisco.'}, {'ForeName': 'Christina R', 'Initials': 'CR', 'LastName': 'Veziris', 'Affiliation': 'Department of Neurology, University of California, San Francisco.'}, {'ForeName': 'Tiffany E', 'Initials': 'TE', 'LastName': 'Chow', 'Affiliation': 'Department of Neurology, University of California, San Francisco.'}, {'ForeName': 'Nathaniel A', 'Initials': 'NA', 'LastName': 'Morris', 'Affiliation': 'Department of Neurology, University of California, San Francisco.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Neuhaus', 'Affiliation': 'Department of Biostatistics, University of California, San Francisco.'}, {'ForeName': 'Joel H', 'Initials': 'JH', 'LastName': 'Kramer', 'Affiliation': 'Department of Neurology, University of California, San Francisco.'}, {'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Miller', 'Affiliation': 'Department of Neurology, University of California, San Francisco.'}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Holley', 'Affiliation': 'Department of Psychiatry, San Francisco State University.'}, {'ForeName': 'Dacher', 'Initials': 'D', 'LastName': 'Keltner', 'Affiliation': 'Department of Psychology, University of California, Berkeley.'}]","Emotion (Washington, D.C.)",['10.1037/emo0000876'] 1373,32936981,A pilot randomized trial of an educational intervention to increase genetic counseling and genetic testing among Latina breast cancer survivors.,"Latinas are less likely to participate in genetic counseling (GC) and genetic testing (GT) than non-Hispanic Whites. A multisite, randomized pilot study tested a culturally targeted educational intervention to increase uptake of GC/GT among Latina breast cancer (BC) survivors (N = 52). Participants were recruited in Tampa, FL and Ponce, PR and randomized to: (a) fact sheet about BC survivorship (control) or (b) a culturally targeted educational booklet about GC/GT (intervention). Participants in the intervention condition were also offered no-cost telephone GC followed by free GT with mail-based saliva sample collection. Participants self-reported hereditary breast and ovarian cancer (HBOC) knowledge and emotional distress at baseline and 1- and 3-month follow-ups. We used logistic regression to examine differences in GC/GT uptake by study arm (primary outcome) and repeated measures ANOVA to examine the effects of study arm and time on HBOC knowledge and emotional distress (secondary outcomes). Compared to the control arm, intervention participants were more likely to complete GC (OR Intervention  = 13.92, 95% CI = 3.06-63.25, p < .01) and GT (OR Intervention  = 12.93, 95% CI = 2.82-59.20, p < .01). Study site did not predict uptake of GC (p = .08) but Ponce participants were more likely to complete GT (OR Ponce  = 4.53, 95% CI = 1.04-19.72, p = .04). ANOVAs demonstrated an increase in HBOC knowledge over time across both groups (F(2,88) = 12.24, p < .01, η p 2  = 0.22). We also found a significant interaction of study arm and time, such that intervention participants demonstrated a greater and sustained (to the 3-month follow-up) increase in knowledge than control participants (F(2,88) = 3.66, p = .03, η p 2  = 0.08). No other main or interaction effects were significant (all p's> .15). Study findings demonstrate the potential of our culturally targeted print intervention. Lessons learned from this multisite pilot study for enhancing GC/GT in Latinas include the need to attend to both access to GC/GT and individual factors such as attitudes and knowledge.",2021,"Compared to the control arm, intervention participants were more likely to complete GC (OR Intervention  = 13.92, 95% CI = 3.06-63.25, p < .01) and GT (OR Intervention  = 12.93, 95% CI = 2.82-59.20, p < .01).","['Latina breast cancer (BC) survivors (N\xa0=\xa052', 'Latina breast cancer survivors']","['culturally targeted educational intervention', 'fact sheet about BC survivorship (control) or (b) a culturally targeted educational booklet about GC/GT (intervention', 'educational intervention']","['hereditary breast and ovarian cancer (HBOC) knowledge and emotional distress', 'HBOC knowledge', 'HBOC knowledge and emotional distress']","[{'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439643', 'cui_str': 'Sheets'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0017382', 'cui_str': 'Genetic counseling'}, {'cui': 'C0679560', 'cui_str': 'Genetic test'}]","[{'cui': 'C0677776', 'cui_str': 'Hereditary breast and ovarian cancer syndrome'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}]",,0.0506475,"Compared to the control arm, intervention participants were more likely to complete GC (OR Intervention  = 13.92, 95% CI = 3.06-63.25, p < .01) and GT (OR Intervention  = 12.93, 95% CI = 2.82-59.20, p < .01).","[{'ForeName': 'Claire C', 'Initials': 'CC', 'LastName': 'Conley', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Eida M', 'Initials': 'EM', 'LastName': 'Castro-Figueroa', 'Affiliation': 'Ponce Health Sciences University, Ponce, PR, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Moreno', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Dutil', 'Affiliation': 'Ponce Health Sciences University, Ponce, PR, USA.'}, {'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'García', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Burgos', 'Affiliation': 'Ponce Health Sciences University, Ponce, PR, USA.'}, {'ForeName': 'Charité', 'Initials': 'C', 'LastName': 'Ricker', 'Affiliation': 'University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, USA.'}, {'ForeName': 'Jongphil', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Kristi D', 'Initials': 'KD', 'LastName': 'Graves', 'Affiliation': 'Georgetown Lombardi Cancer Center, Washington, DC, USA.'}, {'ForeName': 'Kimlin Tam', 'Initials': 'KT', 'LastName': 'Ashing', 'Affiliation': 'City of Hope Medical Center, Duarte, CA, USA.'}, {'ForeName': 'Gwendolyn P', 'Initials': 'GP', 'LastName': 'Quinn', 'Affiliation': 'New York University, Grossman School of Medicine New York, New York, NY, USA.'}, {'ForeName': 'Hatem', 'Initials': 'H', 'LastName': 'Soliman', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Susan T', 'Initials': 'ST', 'LastName': 'Vadaparampil', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}]",Journal of genetic counseling,['10.1002/jgc4.1324'] 1374,32948554,Protocol and statistical analysis plan for the PREventing cardiovascular collaPse with Administration of fluid REsuscitation during Induction and Intubation (PREPARE II) randomised clinical trial.,"INTRODUCTION Cardiovascular collapse is a common complication during tracheal intubation of critically ill adults. Whether administration of an intravenous fluid bolus prevents cardiovascular collapse during tracheal intubation remains uncertain. A prior randomised trial found fluid bolus administration to be ineffective overall but suggested potential benefit for patients receiving positive pressure ventilation during tracheal intubation. METHODS AND ANALYSIS The PREventing cardiovascular collaPse with Administration of fluid REsuscitation during Induction and Intubation (PREPARE II) trial is a prospective, multi-centre, non-blinded randomised trial being conducted in 13 academic intensive care units in the USA. The trial will randomise 1065 critically ill adults undergoing tracheal intubation with planned use of positive pressure ventilation (non-invasive ventilation or bag-mask ventilation) between induction and laryngoscopy to receive 500 mL of intravenous crystalloid or no intravenous fluid bolus. The primary outcome is cardiovascular collapse, defined as any of: systolic blood pressure <65 mm Hg, new or increased vasopressor administration between induction and 2 min after intubation, or cardiac arrest or death between induction and 1 hour after intubation. The primary analysis will be an unadjusted, intention-to-treat comparison of the primary outcome between patients randomised to fluid bolus administration and patients randomised to no fluid bolus administration using a χ 2 test. The sole secondary outcome is 28-day in-hospital mortality. Enrolment began on 1 February 2019 and is expected to conclude in June 2020. ETHICS AND DISSEMINATION The trial was approved by either the central institutional review board at Vanderbilt University Medical Center or the local institutional review board at each trial site. Results will be submitted for publication in a peer-reviewed journal and presented at scientific conferences. TRIAL REGISTRATION NUMBER NCT03787732.",2020,"A prior randomised trial found fluid bolus administration to be ineffective overall but suggested potential benefit for patients receiving positive pressure ventilation during tracheal intubation. ","['13 academic intensive care units in the USA', 'patients receiving positive pressure ventilation during tracheal intubation', '1065 critically ill adults undergoing tracheal intubation with planned use of', 'critically ill adults']","['intravenous fluid bolus', 'fluid REsuscitation', 'positive pressure ventilation (non-invasive ventilation or bag-mask ventilation) between induction and laryngoscopy to receive 500 mL of intravenous crystalloid or no intravenous fluid bolus', 'fluid REsuscitation during Induction and Intubation']","['cardiovascular collapse', '28-day in-hospital mortality', 'cardiovascular collapse, defined as any of: systolic blood pressure <65 mm Hg, new or increased vasopressor administration between induction and 2 min after intubation, or cardiac arrest or death between induction and 1 hour after intubation']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C1524063', 'cui_str': 'Use of'}]","[{'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]","[{'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439227', 'cui_str': 'hour'}]",1065.0,0.64588,"A prior randomised trial found fluid bolus administration to be ineffective overall but suggested potential benefit for patients receiving positive pressure ventilation during tracheal intubation. ","[{'ForeName': 'Derek W', 'Initials': 'DW', 'LastName': 'Russell', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Allergy, & Critical Care Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA dwrussell@uabmc.edu.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Casey', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Kevin W', 'Initials': 'KW', 'LastName': 'Gibbs', 'Affiliation': 'Department of Medicine, Section of Pulmonary, Critical Care, Allergy and Immunologic Disease, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Dargin', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, Lahey Hospital and Medical Center, Burlington, Massachusetts, USA.'}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Vonderhaar', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Ochsner Health System, New Orleans, Louisiana, USA.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Joffe', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Shekhar', 'Initials': 'S', 'LastName': 'Ghamande', 'Affiliation': 'Department of Medicine, Division of Pulmonary Disease and Critical Care Medicine, Baylor Scott & White Medical Center, Temple, Texas, USA.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, Oregon Health & Science University School of Medicine, Portland, Oregon, USA.'}, {'ForeName': 'Simanta', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Department of Medicine, Section of Pulmonary, Critical Care, Allergy and Immunologic Disease, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Janna S', 'Initials': 'JS', 'LastName': 'Landsperger', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Sarah W', 'Initials': 'SW', 'LastName': 'Robison', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Allergy, & Critical Care Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Itay', 'Initials': 'I', 'LastName': 'Bentov', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'Wozniak', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, Lahey Hospital and Medical Center, Burlington, Massachusetts, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Stempek', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, Lahey Hospital and Medical Center, Burlington, Massachusetts, USA.'}, {'ForeName': 'Heath D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Department of Medicine, Division of Pulmonary Disease and Critical Care Medicine, Baylor Scott & White Medical Center, Temple, Texas, USA.'}, {'ForeName': 'Olivia F', 'Initials': 'OF', 'LastName': 'Krol', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, Oregon Health & Science University School of Medicine, Portland, Oregon, USA.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Prekker', 'Affiliation': 'Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Driver', 'Affiliation': 'Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Brewer', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care, and Sleep Medicine, University of Mississippi Medical Center, Jackson, Mississippi, USA.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Christopher John', 'Initials': 'CJ', 'LastName': 'Lindsell', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Wesley H', 'Initials': 'WH', 'LastName': 'Self', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Todd W', 'Initials': 'TW', 'LastName': 'Rice', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Semler', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Janz', 'Affiliation': 'Department of Medicine, Section of Pulmonary/Critical Care Medicine and Allergy/Immunology, Louisiana State University School of Medicine in New Orleans, New Orleans, Louisiana, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-036671'] 1375,32950349,"The effect of yoga on uterine artery Doppler indices, maternal and fetal complications in pregnant women: A quasi-experimental study.","BACKGROUND Today, the effect of yoga has been examined on various physical and psychological dimensions of pregnant women. However, there are still sparse studies on the effect of yoga on the uterine artery indices as well as maternal and fetal complications. OBJECTIVE The aim was to determine the effect of yoga on uterine artery Doppler indices, maternal and fetal Complications. MATERIALS AND METHODS This quasi-experiential study was conducted, on 100 pregnant women. The participants were assigned to yoga and control groups. In the yoga group, the participants exercised yoga for 1 h. On the other hand, the control group received routine care. RESULTS The results showed that in the yoga group, the functional indices of the uterine artery (S/D, PI, RI, and DN) improved more significantly compared to the control (p = 0.01). The results also showed that in the yoga group, maternal complications (diabetes and preeclampsia), as well as fetal complications (SAG, IUGR), were significantly lower compared to the control (p = 0.01). CONCLUSION This study revealed the positive effects of yoga on improving fetal development indices and reducing maternal and fetal complications following pregnancy. It can be used as a Complementary therapy alongside other treatments for mothers.",2021,"The results showed that in the yoga group, the functional indices of the uterine artery (S/D, PI, RI, and DN) improved more significantly compared to the control (p = 0.01).","['pregnant women', 'mothers', '100 pregnant women']",['routine care'],"['fetal complications (SAG, IUGR', 'functional indices of the uterine artery (S/D, PI, RI, and DN', 'uterine artery Doppler indices, maternal and fetal Complications', 'maternal complications (diabetes and preeclampsia', 'fetal development indices and reducing maternal and fetal complications', 'uterine artery Doppler indices, maternal and fetal complications']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0851390', 'cui_str': 'Foetal complications'}, {'cui': 'C0574427', 'cui_str': 'Sango language'}, {'cui': 'C0015934', 'cui_str': 'Fetal growth restriction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0226378', 'cui_str': 'Structure of uterine artery'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0015928', 'cui_str': 'Fetal Development'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",100.0,0.0235501,"The results showed that in the yoga group, the functional indices of the uterine artery (S/D, PI, RI, and DN) improved more significantly compared to the control (p = 0.01).","[{'ForeName': 'Salehoddin', 'Initials': 'S', 'LastName': 'Bouya', 'Affiliation': 'Internal Medicine and Nephrology, Clinical Immunology Research Center, Ali-ebne Abitaleb Hospital, Zahedan University of Medical Sciences, Iran.'}, {'ForeName': 'Leli', 'Initials': 'L', 'LastName': 'Rezaie Keikhaie', 'Affiliation': 'Department of Infectious Disease, School of Medicine, Zabol University of Medical Science, Zabol, Iran.'}, {'ForeName': 'SaraSadat', 'Initials': 'S', 'LastName': 'Hosseini', 'Affiliation': 'Medical-Surgical Nursing, Department of Nursing, Neyshabur University of Medical Science, Neyshabur, Iran.'}, {'ForeName': 'Khadije', 'Initials': 'K', 'LastName': 'Rezaie Keikhaie', 'Affiliation': 'Department of Obstetrics and Gynecology, Zabol University of Medical Sciences, Zabol, Iran. Electronic address: krezak1990@gmail.com.'}]",Journal of Ayurveda and integrative medicine,['10.1016/j.jaim.2020.07.003'] 1376,32943404,Intravenous methylprednisolone pulse as a treatment for hospitalised severe COVID-19 patients: results from a randomised controlled clinical trial.,"INTRODUCTION There are no determined treatment agents for severe COVID-19. It is suggested that methylprednisolone, as an immunosuppressive treatment, can reduce the inflammation of the respiratory system in COVID-19 patients. METHODS We conducted a single-blind, randomised controlled clinical trial involving severe hospitalised patients with confirmed COVID-19 at the early pulmonary phase of the illness in Iran. The patients were randomly allocated in a 1:1 ratio by the block randomisation method to receive standard care with methylprednisolone pulse (intravenous injection, 250 mg·day -1 for 3 days) or standard care alone. The study end-point was the time of clinical improvement or death, whichever came first. Primary and safety analysis was done in the intention-to-treat (ITT) population. RESULTS 68 eligible patients underwent randomisation (34 patients in each group) from April 20, 2020 to June 20, 2020. In the standard care group, six patients received corticosteroids by the attending physician before the treatment and were excluded from the overall analysis. The percentage of improved patients was higher in the methylprednisolone group than in the standard care group (94.1% versus 57.1%) and the mortality rate was significantly lower in the methylprednisolone group (5.9% versus 42.9%; p<0.001). We demonstrated that patients in the methylprednisolone group had a significantly increased survival time compared with patients in the standard care group (log-rank test: p<0.001; hazard ratio 0.293, 95% CI 0.154-0.556). Two patients (5.8%) in the methylprednisolone group and two patients (7.1%) in the standard care group showed severe adverse events between initiation of treatment and the end of the study. CONCLUSIONS Our results suggest that methylprednisolone pulse could be an efficient therapeutic agent for hospitalised severe COVID-19 patients at the pulmonary phase.",2020,"Patients with clinical improvement were higher in the methylprednisolone group than in the standard care group (94·1% versus 57·1%), and the mortality rate was numerically lower in the methylprednisolone group (5·9% versus 42.9%; p <0·001).","['Sixty-eight eligible patients underwent randomisation (34 patients in each group) from April 20, till Jun 20, 2020', 'severe hospitalised patients with confirmed COVID-19 at the early pulmonary phase of the illness in Iran', 'hospitalised severe COVID-19 patients', 'hospitalised severe COVID-19 patients at the pulmonary phase']","['corticosteroids', 'methylprednisolone pulse', 'methylprednisolone intervention', 'methylprednisolone', 'Intravenous methylprednisolone pulse', 'standard care with methylprednisolone pulse (intravenous injection, 250\u2005mg·day -1 for 3\u2005days) or standard care alone']","['time of clinical improvement or death, whichever came first', 'severe adverse events', 'survival time', 'mortality rate']","[{'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0162508', 'cui_str': 'jun Oncogene'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021494', 'cui_str': 'Intravenous injection'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",68.0,0.165073,"Patients with clinical improvement were higher in the methylprednisolone group than in the standard care group (94·1% versus 57·1%), and the mortality rate was numerically lower in the methylprednisolone group (5·9% versus 42.9%; p <0·001).","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Edalatifard', 'Affiliation': 'Advanced Thoracic Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Akhtari', 'Affiliation': 'Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Salehi', 'Affiliation': 'Dept of Infectious and Tropical Medicines, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zohre', 'Initials': 'Z', 'LastName': 'Naderi', 'Affiliation': 'Dept of Internal Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Ahmadreza', 'Initials': 'A', 'LastName': 'Jamshidi', 'Affiliation': 'Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shayan', 'Initials': 'S', 'LastName': 'Mostafaei', 'Affiliation': 'Dept of Biostatistics, School of Health, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Seyed Reza', 'Initials': 'SR', 'LastName': 'Najafizadeh', 'Affiliation': 'Rheumatology Research Center, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Farhadi', 'Affiliation': 'Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nooshin', 'Initials': 'N', 'LastName': 'Jalili', 'Affiliation': 'Dept of Internal Medicine, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Esfahani', 'Affiliation': 'Dept of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Besharat', 'Initials': 'B', 'LastName': 'Rahimi', 'Affiliation': 'Advanced Thoracic Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Kazemzadeh', 'Affiliation': 'Advanced Thoracic Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maedeh', 'Initials': 'M', 'LastName': 'Mahmoodi Aliabadi', 'Affiliation': 'Dept of Laboratory, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Tooba', 'Initials': 'T', 'LastName': 'Ghazanfari', 'Affiliation': 'Immunoregulation Research Center, Shahed University, Tehran, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Sattarian', 'Affiliation': 'Simorgh Clinical Laboratory, Tehran, Iran.'}, {'ForeName': 'Hourvash', 'Initials': 'H', 'LastName': 'Ebrahimi Louyeh', 'Affiliation': 'Dept of Rheumatology, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Reza', 'Initials': 'SR', 'LastName': 'Raeeskarami', 'Affiliation': 'Dept of Pediatrics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeidreza', 'Initials': 'S', 'LastName': 'Jamalimoghadamsiahkali', 'Affiliation': 'Ziaeian Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Khajavirad', 'Affiliation': 'Dept of Internal Medicine, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Mahmoudi', 'Affiliation': 'Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Abdolrahman', 'Initials': 'A', 'LastName': 'Rostamian', 'Affiliation': 'Rheumatology Research Center, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran arostamian@tums.ac.ir.'}]",The European respiratory journal,['10.1183/13993003.02808-2020'] 1377,32949011,"Oral Administration of Live and Dead Cells of Lactobacillus sakei proBio65 Alleviated Atopic Dermatitis in Children and Adolescents: a Randomized, Double-Blind, and Placebo-Controlled Study.","Several studies suggest that probiotics might be useful in the management of atopic dermatitis (AD). However, the efficacy and comparison between both the administration of viable and non-viable probiotics on alleviation of AD is not well studied. Therefore, the purpose of this study was to evaluate the effect of L. sakei proBio65 live and dead cells when administered (1 × 10 10 cells/day) for 12 weeks to children and adolescents (aged 3 to 18) with atopic dermatitis. In this randomized double-blind, placebo-controlled study, ninety patients were recruited and randomly allocated to either the L. sakei proBio65 live cells, L. sakei proBio65 dead cells, or placebo groups. Assessment of efficacy was based on the change in SCORing Atopic Dermatitis (SCORAD) score, Investigators Global Assessment (IGA) score, serum inflammatory markers such as the serum eosinophil (count), IgE, eosinophil cationic protein (ECP), CCL17 (thymus and activation-regulated chemokine [TARC]), and CCL27 (cutaneous T cell-attracting chemokine [CTACK]), and changes in skin condition (moisture and sebum) at baseline, week 6 and week 12. The SCORAD total score decreased in the live cells (p = 0.0015) and dead cell group (p = 0.0017) from the baseline after 12 weeks, whereas there were no significant changes in the placebo group when compared with baseline. The skin sebum content increased in both the live cell (p < 0.0001) and the dead cell group (p < 0.0001), suggesting potential improvements in skin barrier functions. Current data suggested a positive improvement in alleviation of AD symptoms upon oral administration of L. sakei proBio65 in both viable and non-viable forms.",2021,"The SCORAD total score decreased in the live cells (p = 0.0015) and dead cell group (p = 0.0017) from the baseline after 12 weeks, whereas there were no significant changes in the placebo group when compared with baseline.","[' ninety patients', 'children and adolescents (aged 3 to 18) with atopic dermatitis', 'Children and Adolescents']","['L. sakei proBio65 live cells, L. sakei proBio65 dead cells, or placebo', 'placebo', 'sakei', 'Live and Dead Cells of Lactobacillus sakei proBio65', 'Placebo']","['SCORing Atopic Dermatitis (SCORAD) score, Investigators Global Assessment (IGA) score, serum inflammatory markers such as the serum eosinophil (count), IgE, eosinophil cationic protein (ECP), CCL17 (thymus and activation-regulated chemokine [TARC]), and CCL27 (cutaneous T cell-attracting chemokine [CTACK]), and changes in skin condition (moisture and sebum', 'SCORAD total score', 'skin barrier functions', 'skin sebum content', 'Atopic Dermatitis']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}]","[{'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0317639', 'cui_str': 'Lactobacillus sakei'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0950373', 'cui_str': 'Eosinophilic cationic protein'}, {'cui': 'C0539535', 'cui_str': 'CCL17 protein, human'}, {'cui': 'C0768285', 'cui_str': 'CCL27 protein, human'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0037274', 'cui_str': 'Disorder of skin'}, {'cui': 'C0036511', 'cui_str': 'Sebum'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",90.0,0.328581,"The SCORAD total score decreased in the live cells (p = 0.0015) and dead cell group (p = 0.0017) from the baseline after 12 weeks, whereas there were no significant changes in the placebo group when compared with baseline.","[{'ForeName': 'Irfan A', 'Initials': 'IA', 'LastName': 'Rather', 'Affiliation': 'College of Life and Applied Sciences, Yeungnam University, Gyeongsan, South Korea.'}, {'ForeName': 'Byung-Chun', 'Initials': 'BC', 'LastName': 'Kim', 'Affiliation': 'Probionic Corporation, Jeonbuk Institute for Food-Bioindustry, Jeonju, South Korea.'}, {'ForeName': 'Lee-Ching', 'Initials': 'LC', 'LastName': 'Lew', 'Affiliation': 'College of Life and Applied Sciences, Yeungnam University, Gyeongsan, South Korea.'}, {'ForeName': 'Seong-Kwan', 'Initials': 'SK', 'LastName': 'Cha', 'Affiliation': 'Hansung Food Co., Ltd, Bucheon, South Korea.'}, {'ForeName': 'Jong Hwan', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Probionic Corporation, Jeonbuk Institute for Food-Bioindustry, Jeonju, South Korea.'}, {'ForeName': 'Gyeong-Jun', 'Initials': 'GJ', 'LastName': 'Nam', 'Affiliation': 'College of Life and Applied Sciences, Yeungnam University, Gyeongsan, South Korea.'}, {'ForeName': 'Rajib', 'Initials': 'R', 'LastName': 'Majumder', 'Affiliation': 'College of Life and Applied Sciences, Yeungnam University, Gyeongsan, South Korea.'}, {'ForeName': 'Jeongheui', 'Initials': 'J', 'LastName': 'Lim', 'Affiliation': 'National Science Museum, Ministry of Science, ICT and Future Planning, Daejeon, South Korea.'}, {'ForeName': 'Seul-Ki', 'Initials': 'SK', 'LastName': 'Lim', 'Affiliation': 'Oracle Dermatologic Clinic, Sejong, South Korea.'}, {'ForeName': 'Young-Joon', 'Initials': 'YJ', 'LastName': 'Seo', 'Affiliation': 'Department of Dermatology, School of Medicine, Chungnam National University, Daejeon, South Korea. joon@cnu.ac.kr.'}, {'ForeName': 'Yong-Ha', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'College of Life and Applied Sciences, Yeungnam University, Gyeongsan, South Korea. peter@ynu.ac.kr.'}]",Probiotics and antimicrobial proteins,['10.1007/s12602-020-09654-7'] 1378,32955023,Positive tendency toward synchronous use of acetaminophen and ibuprofen in treating patients with patent ductus arteriosus.,"OBJECTIVE Spontaneous closure of the ductus arteriosus often fails to occur in premature newborns and this condition can be associated with increased morbidity and mortality. The initial treatment to achieve closure of the opening is pharmacological, and various nonsteroidal anti-inflammatory drugs may be used. The aim of this study was to determine whether combining acetaminophen with ibuprofen is more effective than the individual use of these drugs to treat patent ductus arteriosus (PDA). METHODS The present randomized, controlled trial study included 154 premature newborns with PDA. The patients were randomized into 3 groups: the acetaminophen group (n=67), ibuprofen group (n=68), and combination drug group (n=19). Echocardiography was performed before initiating the medication and after completing a first and second course of treatment. Blood markers were measured to assess the safety of the 3 types of therapy. RESULTS After the first course of treatment, PDA closure was seen in 76.1% of the infants in the acetaminophen group, 76.4% of those in the ibuprofen group, and 78.9% of the combination therapy group (p=0.97). The closure rate after a second course of treatment was 43.7% in the acetaminophen group, 62.5% in the ibuprofen group, and 100% in the combination group. There were no complications attributed to the 3 methods of treatment used. CONCLUSION Concomitant use of acetaminophen and ibuprofen can be an effective option for closure of PDA. Other studies with a larger sample size are recommended in order to confirm these results.",2020,"There were no complications attributed to the 3 methods of treatment used. ","['154 premature newborns with PDA', 'patent ductus arteriosus (PDA', 'patients with patent ductus arteriosus', 'premature newborns']","['acetaminophen', 'acetaminophen with ibuprofen', 'acetaminophen and ibuprofen', 'ibuprofen']","['PDA closure', 'morbidity and mortality', 'closure rate', 'Blood markers']","[{'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0233315', 'cui_str': 'Premature birth of newborn'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}]","[{'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",154.0,0.0244522,"There were no complications attributed to the 3 methods of treatment used. ","[{'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Oboodi', 'Affiliation': 'Neonatal Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Khadijeh Sadat', 'Initials': 'KS', 'LastName': 'Najib', 'Affiliation': 'Neonatal Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Amoozgar', 'Affiliation': 'Department of Pediatric Cardiology, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Shahnaz', 'Initials': 'S', 'LastName': 'Pourarian', 'Affiliation': 'Neonatal Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Moghtaderi', 'Affiliation': 'Neonatal Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Mehdizadegan', 'Affiliation': 'Department of Pediatric Cardiology, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Sabzevari', 'Affiliation': 'Neonatal Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Turk Kardiyoloji Dernegi arsivi : Turk Kardiyoloji Derneginin yayin organidir,['10.5543/tkda.2020.03902'] 1379,32950650,The p Factor Consistently Predicts Long-Term Psychiatric and Functional Outcomes in Anxiety-Disordered Youth.,"OBJECTIVE Pediatric anxiety disorders can have a chronic course and are considered gateway disorders to adult psychopathology, but no consistent predictors of long-term outcome have been identified. A single latent symptom dimension that reflects features shared by all mental health disorders, the p factor, is thought to reflect mechanisms that cut across mental disorders. Whether p predicts outcome in youth with psychiatric disorders has not been examined. We tested whether the p factor predicted long-term psychiatric and functional outcomes in a large, naturalistically followed-up cohort of anxiety-disordered youth. METHOD Children and adolescents enrolled in a randomized controlled treatment trial of pediatric anxiety were followed-up on average 6 years posttreatment and then annually for 4 years. Structural equation modeling was used to estimate p at baseline. Both p and previously established predictors were modeled as predictors of long-term outcome. RESULTS Higher levels of p at baseline were related to more mental health disorders, poorer functioning, and greater impairment across all measures at all follow-up time points. p Predicted outcome above and beyond previously identified predictors, including diagnostic comorbidity at baseline. Post hoc analyses showed that p predicted long-term anxiety outcome, but not acute treatment outcome, suggesting that p may be uniquely associated with long-term outcome. CONCLUSION Children and adolescents with anxiety disorders who present with a liability toward broad mental health problems may be at a higher risk for poor long-term outcome across mental health and functional domains. Efforts to assess and to address this broad liability may enhance long-term outcome.",2020,"RESULTS Higher levels of p at baseline were related to more mental health disorders, poorer functioning, and greater impairment across all measures at all follow-up time points.","['Youth with anxiety disorders', 'youth with psychiatric disorders', 'Youth enrolled']",[],"['mental health disorders, poorer functioning', 'diagnostic comorbidity']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]",[],"[{'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]",,0.0743218,"RESULTS Higher levels of p at baseline were related to more mental health disorders, poorer functioning, and greater impairment across all measures at all follow-up time points.","[{'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Cervin', 'Affiliation': 'Lund University, Sweden. Electronic address: matti.cervin@med.lu.se.'}, {'ForeName': 'Lesley A', 'Initials': 'LA', 'LastName': 'Norris', 'Affiliation': 'Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Golda', 'Initials': 'G', 'LastName': 'Ginsburg', 'Affiliation': 'University of Connecticut School of Medicine, West Hartford, Connecticut.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Gosch', 'Affiliation': 'Philadelphia College of Osteopathic Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Scott N', 'Initials': 'SN', 'LastName': 'Compton', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Piacentini', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, California.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Albano', 'Affiliation': 'Columbia University, New York, New York.'}, {'ForeName': 'Dara', 'Initials': 'D', 'LastName': 'Sakolsky', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Birmaher', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Keeton', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Storch', 'Affiliation': 'Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Kendall', 'Affiliation': 'Temple University, Philadelphia, Pennsylvania.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2020.08.440'] 1380,32944800,"Efficacy and safety of lipegfilgrastim versus pegfilgrastim in elderly patients with aggressive B cell non-Hodgkin lymphoma (B-NHL): results of the randomized, open-label, non-inferiority AVOID neutropenia study.","BACKGROUND Lipegfilgrastim has been shown to be non-inferior to pegfilgrastim for reduction of the duration of severe neutropenia (DSN) in breast cancer patients. This open-label, non-inferiority study assessed the efficacy and safety of lipegfilgrastim versus pegfilgrastim in elderly patients with aggressive B cell non-Hodgkin lymphoma (NHL) at high risk for chemotherapy-induced neutropenia. PATIENT AND METHODS One hundred and one patients (median age, 75 years) were randomized to lipegfilgrastim or pegfilgrastim (6 mg/cycle) during six cycles of R-CHOP21. RESULTS Lipegfilgrastim was non-inferior to pegfilgrastim for the primary efficacy endpoint, reduction of DSN in cycle 1. In the per-protocol population, mean (standard deviation) DSN was 0.8 (0.92) and 0.9 (1.11) days in the two groups, respectively; the adjusted mean difference between groups was - 0.3 days (95% confidence interval, - 0.70 to 0.19). Non-inferiority was also demonstrated in the intent-to-treat population. The incidence of severe neutropenia in cycle 1 was 51% (21/41) in the lipegfilgrastim group and 52% (23/44) in the pegfilgrastim group. Very severe neutropenia (ANC < 0.1 × 10 9 /L) in cycle 1 was reported by 5 (12%) patients in the lipegfilgrastim group and 8 (18%) patients in the pegfilgrastim group. However, over all cycles, febrile neutropenia (strict definition) was reported by only 1 (2%) patient in each treatment group (during cycle 1 in the lipegfilgrastim group and cycle 6 in the pegfilgrastim group). The mean time to absolute neutrophil count recovery (defined as ≥ 2.0 × 10 9 /L) was 8.3 and 9.4 days in the two groups, respectively. Serious adverse events occurred in 46% of patients in each group; none were considered treatment-related. Eight patients died during the study (2 in the lipegfilgrastim group, 5 in the pegfilgrastim group, and 1 who died before starting study treatment). No deaths occurred during the treatment period, and all were considered to be related to the underlying disease. CONCLUSIONS This study shows lipegfilgrastim to be non-inferior to pegfilgrastim for the reduction of DSN in elderly patients with aggressive B cell NHL receiving myelosuppressive chemotherapy, with a comparable safety profile. TRIAL REGISTRATION NUMBER ClinicalTrials.gov identifier NCT02044276; EudraCT number 2013-001284-23.",2021,"This study shows lipegfilgrastim to be non-inferior to pegfilgrastim for the reduction of DSN in elderly patients with aggressive B cell NHL receiving myelosuppressive chemotherapy, with a comparable safety profile. ","['elderly patients with aggressive B cell NHL receiving', 'One hundred and one patients (median age, 75 years', 'elderly patients with aggressive B cell non-Hodgkin lymphoma (B-NHL', 'breast cancer patients', 'elderly patients with aggressive B cell non-Hodgkin lymphoma (NHL) at high risk for chemotherapy-induced neutropenia']","['pegfilgrastim', 'myelosuppressive chemotherapy', 'lipegfilgrastim versus pegfilgrastim', 'lipegfilgrastim or pegfilgrastim']","['severe neutropenia', 'febrile neutropenia', 'efficacy and safety', 'Serious adverse events', 'deaths', 'Efficacy and safety', 'Very severe neutropenia', 'mean time to absolute neutrophil count recovery']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0079731', 'cui_str': 'B-cell lymphoma (clinical)'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024305', 'cui_str': 'Malignant lymphoma, non-Hodgkin'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1827687', 'cui_str': 'Chemotherapy-induced neutropenia'}]","[{'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3640212', 'cui_str': 'lipegfilgrastim'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}]",,0.0414948,"This study shows lipegfilgrastim to be non-inferior to pegfilgrastim for the reduction of DSN in elderly patients with aggressive B cell NHL receiving myelosuppressive chemotherapy, with a comparable safety profile. ","[{'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Link', 'Affiliation': 'Private Practice Hematology Medical Oncology, Finkenhain 8, 67661, Kaiserslautern, Germany. hlink@kabelmail.de.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Illerhaus', 'Affiliation': 'Hematology, Oncology and Palliative Medicine Clinic, Klinikum Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'U M', 'Initials': 'UM', 'LastName': 'Martens', 'Affiliation': 'Hematology, Oncology and Palliative Medicine Clinic, SLK-Clinics, Heilbronn, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Salar', 'Affiliation': 'Hospital del Mar Paseo Marítimo, Hematology, Barcelona, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Depenbusch', 'Affiliation': 'Oncology Practice, Gütersloh, Gütersloh, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Köhler', 'Affiliation': 'Hematology and Oncology Collective Practice, Asklepios Clinic Specialist Medical Centre Langen, Langen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Engelhardt', 'Affiliation': 'Internal Medicine Clinic I, Hematology, Oncology and Stem Cell Transplantation, University Clinic, Faculty of Freiburg, Freiburg, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mahlmann', 'Affiliation': 'Hematology/Oncology and Nephrology Clinic, Friedrich-Ebert-Hospital Neumünster, Neumünster, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zaiss', 'Affiliation': 'Interdiscliplinary Practice for Oncology and Hematology, Freiburg, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lammerich', 'Affiliation': 'Teva Pharmaceuticals Industries, Ulm, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bias', 'Affiliation': 'Teva Pharmaceuticals Industries, Ulm, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Buchner', 'Affiliation': 'Teva Pharmaceuticals Industries, Ulm, Germany.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05711-7'] 1381,32948471,Grip Strength and Demographic Variables Estimate Appendicular Muscle Mass Better Than Bioelectrical Impedance in Taiwanese Older Persons.,"OBJECTIVES This study aimed to develop an equation model combining physical fitness and anthropometric parameters and compare its results with those of bioelectrical impedance analysis (BIA)-measured lean mass (LM) using dual-energy X-ray absorptiometry (DXA)-measured appendicular muscle mass (AMM) as reference. DESIGN Observational analysis. SETTING AND PARTICIPANTS Healthy community-dwelling older subjects. METHODS A total of 1020 participants were randomly allocated to the development group (development group, n = 510) or the cross-validation group (validation group, n = 510). Body composition was measured using both DXA and BIA, and physical fitness parameters, including grip strength, timed stepping test, sit-to-stand test, flexibility, and walking speed were also assessed. A prediction equation model of AMM by stepwise linear regression analysis that included or excluded 1 independent variable at each step, based on the P value of significance (P < .05), was developed. RESULTS Using weight, sex, height, and handgrip strength as independent variables, the equation AMM = -9.833 + 0.397 × weight (kg) + 4.433 × sex + 0.121 × height (cm) + 0.061 × handgrip strength (kg) best predicts DXA-measured AMM (adjusted R 2  = 0.914, SEE = 2.062, P < .001). The predicted AMM was more highly correlated with DXA-measured AMM than the commonly used BIA-measured LM (R 2 = 0.9158 and 0.8427, respectively, both P < .001). Using DXA-measured AMM as reference, the Bland-Altman plot showed mean differences of -0.03 kg and -0.12 kg, with limits of agreement of -3.98 to 3.92 kg and -5.97 to 5.73 kg for the predicted AMM and BIA-measured AMM, respectively. CONCLUSIONS AND IMPLICATIONS The proposed equation offers a practical alternative method for estimating AMM that is less facility-dependent and more easy to use and affordable than instrumental studies.",2021,"× handgrip strength (kg) best predicts DXA-measured AMM (adjusted R 2  = 0.914, SEE = 2.062, P < .001).","['4.433\xa0×\xa0sex\xa0+\xa00.121\xa0×\xa0height (cm)\xa0+\xa00.061', '1020 participants', 'Taiwanese Older Persons', 'Healthy community-dwelling older subjects']",['9.833\xa0+\xa00.397\xa0×\xa0weight (kg)\xa0'],"['DXA and BIA, and physical fitness parameters, including grip strength, timed stepping test, sit-to-stand test, flexibility, and walking speed', 'Body composition', '×\xa0handgrip strength (kg) best predicts DXA-measured AMM', 'Grip Strength and Demographic Variables Estimate Appendicular Muscle']","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C1556096', 'cui_str': 'Taiwanese'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0162536', 'cui_str': 'Biolectric Impedance'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",1020.0,0.0451526,"× handgrip strength (kg) best predicts DXA-measured AMM (adjusted R 2  = 0.914, SEE = 2.062, P < .001).","[{'ForeName': 'Ming-Yen', 'Initials': 'MY', 'LastName': 'Hsiao', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, National Taiwan University College of Medicine, Taipei, Taiwan; Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ke-Vin', 'Initials': 'KV', 'LastName': 'Chang', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, National Taiwan University College of Medicine, Taipei, Taiwan; Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Bei-Hu Branch, Taipei, Taiwan; Community and Geriatric Medicine Research Center, National Taiwan University Hospital, Bei-Hu Branch, Taipei, Taiwan.'}, {'ForeName': 'Wei-Ting', 'Initials': 'WT', 'LastName': 'Wu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Bei-Hu Branch, Taipei, Taiwan.'}, {'ForeName': 'Kuo-Chin', 'Initials': 'KC', 'LastName': 'Huang', 'Affiliation': 'Community and Geriatric Medicine Research Center, National Taiwan University Hospital, Bei-Hu Branch, Taipei, Taiwan; Department of Family Medicine, National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Der-Sheng', 'Initials': 'DS', 'LastName': 'Han', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, National Taiwan University College of Medicine, Taipei, Taiwan; Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Bei-Hu Branch, Taipei, Taiwan; Community and Geriatric Medicine Research Center, National Taiwan University Hospital, Bei-Hu Branch, Taipei, Taiwan; Health Science and Wellness Center, National Taiwan University, Taipei, Taiwan. Electronic address: dshan1121@yahoo.com.tw.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2020.08.003'] 1382,32954487,Responder Profile to Pharmaceutical-Grade Chondroitin Sulfate: An Analysis of the CONCEPT Trial.,"INTRODUCTION The recent CONCEPT study showed that 800 mg/day of pharmaceutical-grade chondroitin sulfate (CS) was superior to placebo and similar to celecoxib in reducing pain and improving function over 6 months in patients with symptomatic knee osteoarthritis (OA). We investigate, in the present study, whether a responder profile to CS could be defined (i.e., to determine a patient's profile with the best response to treatment). METHODS Subjects from the CS group of the CONCEPT study were included in the present analysis. Within the CS group, various subgroups were created on the basis of different categories of age, sex, body mass index, Kellgren and Lawrence grade, age since the beginning of OA, and baseline level of pain (i.e., VAS) or function (i.e., Lequesne index). The nonparametric Kruskal-Wallis (KW) test was applied to compare the VAS pain/Lequesne index evolutions between the subgroups, and the Dwass, Steel, Critchlow, Fligner (DSCF) procedure was used to compute multiple comparisons. The impact of various covariates on the VAS pain/Lequesne index evolution was assessed by means of multiple regression. RESULTS Across all analyses, the probability of response to CS treatment was significantly associated with the duration between the date of diagnosis and the initiation of treatment. In other words, the shorter the interval between the diagnosis and the beginning of the treatment, the higher the response for both pain and function, particularly for patients with a duration of less than 5 years compared to patients with a duration of 10 years or more. No other criteria were found to be consistently associated with the response to CS treatment. CONCLUSION The treatment of OA with CS has the highest chance of success if administered in the early stage of the disease. Further research with other clinical outcomes should be carried out prior to widespread application of these findings. TRIAL REGISTRATION ClinicalTrials.gov identifier, NCT03200288.",2020,"No other criteria were found to be consistently associated with the response to CS treatment. ","['Subjects from the CS group of the CONCEPT study were included in the present analysis', 'patients with symptomatic knee osteoarthritis (OA']","['OA with CS', 'pharmaceutical-grade chondroitin sulfate (CS', 'placebo', 'celecoxib']","['probability of response to CS treatment', 'Lequesne index evolution', 'pain and improving function', 'VAS pain']","[{'cui': 'C0008466', 'cui_str': 'Chondroitin Sulfates'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0008466', 'cui_str': 'Chondroitin Sulfates'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0008466', 'cui_str': 'Chondroitin Sulfates'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0451257', 'cui_str': 'Lequesne index'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0274737,"No other criteria were found to be consistently associated with the response to CS treatment. ","[{'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bruyère', 'Affiliation': 'Division of Public Health, Epidemiology and Health Economics, WHO Collaborating Centre for Public Health Aspects of Musculoskeletal Health and Ageing, University of Liège, Liège, Belgium. olivier.bruyere@uliege.be.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Dardenne', 'Affiliation': 'Department of Biostatistics, University of Liège, Liège, Belgium.'}, {'ForeName': 'Anne-Françoise', 'Initials': 'AF', 'LastName': 'Donneau', 'Affiliation': 'Department of Biostatistics, University of Liège, Liège, Belgium.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Reginster', 'Affiliation': 'Division of Public Health, Epidemiology and Health Economics, WHO Collaborating Centre for Public Health Aspects of Musculoskeletal Health and Ageing, University of Liège, Liège, Belgium.'}]",Advances in therapy,['10.1007/s12325-020-01484-x'] 1383,32954628,"The ""Painting by Numbers Method"" for education of students in crown preparation.","INTRODUCTION No commercially available solution to improve the teaching of a crown preparation directly on typodont teeth exists at the moment. To fill this gap and support the supervisors of dental courses, a printable and inexpensive tooth was created for structured self-assessment. The aim of this study was to test this printable tooth under realistic pre-clinical situations. MATERIALS AND METHODS A two-coloured, double-layer practice tooth was developed. This tooth was consisting of a layer for a correct preparation and the crown. All printed teeth were produced with a stereolithographic printer. 35 voluntary second-year dental students in the second pre-clinical course in prosthodontics were randomly divided into two groups. All students had experience with typodont teeth and models. The first group was trained on four standard model teeth. The second group used model teeth for the first and fourth attempt and printed teeth for second and third attempt. The preparations of the students were scanned by an in-lab scanner and the surface deviations in contrast to a perfect preparation were measured. The differences between the first and fourth attempt were calculated. Benefits of the printed tooth were also evaluated by a questionnaire using German school grades completed by the students (1 = Excellent, 2 = Good, 3 = Satisfactory, 4 = Adequate, 5 = Poor, 6 = Unsatisfactory). RESULTS The workflow was feasible and cost-effective regarding the production of the printed teeth. The overall rating of the printed tooth in the questionnaire was good (Ø 2.1 ± 0.22). Students reported different advantages of this method in the free text. The comparison of the preparation between the first and fourth attempt showed that there was a significant better preparation with the printed teeth. The complete preparation had median values of 0.05 mm (Group1: standard model tooth) and -0.03 mm (Group2: printed tooth) (P = .005). Divided into single surfaces, the vestibular and occlusal regions were significantly better. The vestibular surface was 0.11 mm (Group1) and -0.04 mm (Group2) (P = .018). The occlusal surface was 0.13 mm (Group1) and -0.05 mm (Group2) (P = .009). CONCLUSIONS The aim of this study was fulfilled. The printed tooth was tested successfully in a pre-clinical course. The feasibility of this teaching concept was confirmed by the questionnaire and the analysis of the preparation form. A significant difference to a standard model tooth was measurable. The students had the possibility to learn a correct crown preparation on a standardised two-layered tooth with included preparation. This printed tooth enabled the students to control the crown preparation directly on their own.",2021,"The occlusal surface was 0.13mm (Group1) and -0.05mm (Group2) (p=.009). ","['35 voluntary second-year dental students in the second preclinical course in prosthodontics', 'All students had experience with typodont teeth and models', 'students had the possibility to learn a correct crown preparation on a standardized two layered tooth with included preparation']",[],"['overall rating of the printed tooth', 'occlusal surface', 'vestibular surface']","[{'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0033590', 'cui_str': 'Prosthodontics'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0205148', 'cui_str': 'Surface'}]",35.0,0.0217737,"The occlusal surface was 0.13mm (Group1) and -0.05mm (Group2) (p=.009). ","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Höhne', 'Affiliation': 'Department of Prosthodontics, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Jentzsch', 'Affiliation': 'Department of Prosthodontics, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Schmitter', 'Affiliation': 'Department of Prosthodontics, University of Würzburg, Würzburg, Germany.'}]",European journal of dental education : official journal of the Association for Dental Education in Europe,['10.1111/eje.12599'] 1384,32950989,"Weight Loss, Dietary Preferences, and Reduction in the Sense of Smell with the Use of a Novel Nasal Device.","INTRODUCTION Exposure to food odors are known to increase food intake. Olfaction declines from age 50 years. OBJECTIVE We examined changes in the sense of smell, body weight, food preferences, and parameters of metabolic status, following the use of a specially designed nasal device. METHODS This is a randomized, placebo-controlled study. Participants wore a nasal device (soft silicone insert) for 5-12 h daily (device group) or inserted 2 drops of normal saline into each nostril daily (control group). Follow-up visits occurred every 2 weeks. All participants were given a 500 kcal/day reduced diet and instructed not to change their regular physical activity. Weight, food preferences, olfactory sensitivity, and blood tests were performed at baseline and after 12 weeks. RESULTS Of 156 participants, 65 (42%) completed the study. Sense of smell decreased in the device group (from 6.4 ± 0.9 to 4.4 ± 1.5, on a scale of 0-7, p < 0.001), and did not change in the control group. Weight loss decreased by 6.6 ± 3.7% (p = 0.001) and by 5.7 ± 3.5% (p = 0.001) in the respective groups (between-group difference, p > 0.05). Among participants aged ≤50 years, weight loss was greater in the device than in the control group (7.7 ± 4.2% vs. 4.1 ± 2.9%, p = 0.02). Insulin level and the homeostatic model assessment of insulin resistance (HOMA-IR) were significantly reduced in the device group (p = 0.02 and p = 0.01, respectively), but not in the control group. Food preferences for sugar (p < 0.02), sweet beverages (p < 0.001), and artificial sweeteners (p < 0.02) were significantly reduced in the device group compared to the control group. CONCLUSIONS The use of a novel self-administrated nasal device led to reduced olfactory sensitivity, improved insulin sensitivity, weight loss, and lesser preference for sweets in adults aged ≤50 years.",2020,"Insulin level and the homeostatic model assessment of insulin resistance (HOMA-IR) were significantly reduced in the device group (p = 0.02 and p = 0.01, respectively), but not in the control group.","['Of 156 participants, 65 (42%) completed the study', 'adults aged ≤50 years']","['placebo', 'nasal device (soft silicone insert) for 5-12 h daily (device group) or inserted 2 drops of normal saline into each nostril daily (control group']","['Weight, food preferences, olfactory sensitivity, and blood tests', 'weight loss', 'artificial sweeteners', 'insulin sensitivity, weight loss, and lesser preference for sweets', 'Sense of smell', 'Insulin level and the homeostatic model assessment of insulin resistance (HOMA-IR', 'sweet beverages', 'Weight Loss, Dietary Preferences, and Reduction in the Sense of Smell', 'Weight loss']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0595944', 'cui_str': 'Both anterior nares'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0016483', 'cui_str': 'Food Preferences'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0003920', 'cui_str': 'Artificial sweetener'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}]",,0.0873482,"Insulin level and the homeostatic model assessment of insulin resistance (HOMA-IR) were significantly reduced in the device group (p = 0.02 and p = 0.01, respectively), but not in the control group.","[{'ForeName': 'Dror', 'Initials': 'D', 'LastName': 'Dicker', 'Affiliation': 'Internal Medicine D and Obesity Clinic, Hasharon Hospital, Rabin Medical Center, Petach-Tikva, Israel, daniel3@013.net.'}, {'ForeName': 'Adva', 'Initials': 'A', 'LastName': 'Beck', 'Affiliation': 'Beck Medical, Givat-Ada, Israel.'}, {'ForeName': 'Arie', 'Initials': 'A', 'LastName': 'Markel', 'Affiliation': 'Haemek Medical Center, Afula, Israel.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Marcovicu', 'Affiliation': 'Internal Medicine D and Obesity Clinic, Hasharon Hospital, Rabin Medical Center, Petach-Tikva, Israel.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Mazzawi', 'Affiliation': 'Otolaryngology Head and Neck Surgery, Haemek Medical Center, Rappaport School of Medicine, Technion, Israel.'}, {'ForeName': 'Miri', 'Initials': 'M', 'LastName': 'Sarid', 'Affiliation': 'Western Galilee College, Akko, Israel.'}, {'ForeName': 'Elhanan', 'Initials': 'E', 'LastName': 'Greenberg', 'Affiliation': 'Beck Medical, Givat-Ada, Israel.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Atkinson', 'Affiliation': 'Virginia Commonwealth University School of Medicine, Richmond, Virginia, USA.'}]",Obesity facts,['10.1159/000508976'] 1385,33236097,"Transition to Adult IBD Care: A Pilot Multi-Site, Telehealth Hybrid Intervention.","OBJECTIVE Transition to adult IBD care continues to be a challenge. Efficacious models of improving transition to adult care in the United States are lacking. We present data from a pilot, prospective, non-randomized, intervention implemented at IBD centers in the Midwest and Southeast United States. DESIGN AND METHODS Adolescents and young adults (AYAs; 16-20 years) with IBD and their parents completed a 4- to 5-month transition program (1 in-person group session; 4 individual telehealth sessions). Primary outcomes were feasibility (i.e., recruitment, retention, fidelity) and acceptability (i.e., program satisfaction). Secondary outcomes were changes in transition readiness, self-management skill acquisition, perceived readiness to transfer to adult care, and disease knowledge. RESULTS The study exceeded goals for recruitment (target N = 20; actual: 36) and retention (target: 80%; actual: 86.11%). On average, it took participants 20.91 ± 3.15 weeks to complete our 4- to 5-month intervention and there were no deviations from the study protocol. Participant ratings for overall program satisfaction, perceived helpfulness, and program length and format were positive. Increases in transition readiness, t(30) = 8.30, d = 1.49, p < .001, self-management skill acquisition, t(30) = 3.93, d = 0.70, p < .001, and disease knowledge, t(30) = 8.20, d = 1.58, p < .001 were noted. AYA- and parent-perceived transfer readiness also improved (p's < .05; d's = 0.76-1.68). CONCLUSIONS This article presents feasibility and acceptability data for a 4- to 5-month transition intervention. Improvements in AYA transition readiness, self-management skill acquisition, IBD knowledge, and AYA/parent perceived transfer readiness were also observed.",2021,"Improvements in AYA transition readiness, self-management skill acquisition, IBD knowledge, and AYA/parent perceived transfer readiness were also observed.","['Adolescents and young adults (AYAs; 16-20\u2009years) with IBD and their parents completed a', 'Transition to Adult IBD Care', 'IBD centers in the Midwest and Southeast United States']",['4- to 5-month transition program (1 in-person group session; 4 individual telehealth sessions'],"['changes in transition readiness, self-management skill acquisition, perceived readiness to transfer to adult care, and disease knowledge', 'Participant ratings for overall program satisfaction, perceived helpfulness, and program length and format', 'feasibility (i.e., recruitment, retention, fidelity) and acceptability (i.e., program satisfaction', 'Improvements in AYA transition readiness, self-management skill acquisition, IBD knowledge, and AYA/parent perceived transfer readiness']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C3178922', 'cui_str': 'Pediatric Transition To Adult Care'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}]",,0.064322,"Improvements in AYA transition readiness, self-management skill acquisition, IBD knowledge, and AYA/parent perceived transfer readiness were also observed.","[{'ForeName': 'Wendy N', 'Initials': 'WN', 'LastName': 'Gray', 'Affiliation': 'Department of Psychology, Auburn University.'}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Wagoner', 'Affiliation': 'Department of Psychology, Auburn University.'}, {'ForeName': 'Megan R', 'Initials': 'MR', 'LastName': 'Schaefer', 'Affiliation': 'Department of Psychology, Auburn University.'}, {'ForeName': 'Bonney', 'Initials': 'B', 'LastName': 'Reed', 'Affiliation': ""Department of Pediatrics, Children's Healthcare of Atlanta, Emory University School of Medicine.""}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Morgan', 'Affiliation': ""Department of Gastroenterology, Hepatology and Nutrition, Cincinnati Children's Hospital Medical Center.""}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Holbrook', 'Affiliation': ""Department of Gastroenterology, Hepatology and Nutrition, Cincinnati Children's Hospital Medical Center.""}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Yacyshyn', 'Affiliation': 'Department of Internal Medicine, University of Cincinnati College of Medicine.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mackner', 'Affiliation': ""Division of Pediatric Psychology and Neuropsychology, Nationwide Children's Hospital, Department of Pediatrics, Center for Biobehavioral Health, The Ohio State University.""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Young', 'Affiliation': 'Department of Psychology, Auburn University.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Maddux', 'Affiliation': ""Division of Developmental and Behavioral Sciences/Division of Gastroenterology, Department of Pediatrics, Children's Mercy-Kansas City, University of Missouri-Kansas City School of Medicine.""}, {'ForeName': 'Shehzad A', 'Initials': 'SA', 'LastName': 'Saeed', 'Affiliation': ""Department of Gastroenterology, Hepatology and Nutrition, Cincinnati Children's Hospital Medical Center.""}, {'ForeName': 'Lee A', 'Initials': 'LA', 'LastName': 'Denson', 'Affiliation': ""Department of Gastroenterology, Hepatology and Nutrition, Cincinnati Children's Hospital Medical Center.""}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Hommel', 'Affiliation': ""Department of Behavioral Medicine & Clinical Psychology, Cincinnati Children's Hospital Medical Center.""}]",Journal of pediatric psychology,['10.1093/jpepsy/jsaa088'] 1386,32957336,The prolongation effect of ilaprazole-based standard triple therapy for Helicobacter pylori.,"BACKGROUND Helicobacter pylori (HP) infection causes many diseases, such as peptic ulcers, gastritis and gastric cancer, and MALToma. It has been gradually accepted that all HP-infected patients should be treated because HP is regarded as an infection. Therefore, the importance of selecting the optimal treatment regimen has increased. Although the 14-day standard triple therapy (STT) is recommended in the current guidelines, prolonging treatment duration is controversial in real practice because of inconsistent results from previous data and the risk of adverse effects. Additionally, the effect of STT using ilaprazole has not been reported until now. We aimed to compare the eradication rate between 7 and 10 days STT using ilaprazole. METHODS A prospective randomized controlled trial was conducted, which was divided into 2 treatment groups: the control group was 7 days of STT, and the test group was 10 days of STT. The eradication regimen was 10 mg ilaprazole, 500 mg clarithromycin, and 1000 mg amoxicillin twice daily. We included patients who were diagnosed with positive results of H pylori examination. We compared the HP eradication rate according to treatment duration, CYP2C19 subtype and endoscopic diagnosis. RESULTS We enrolled a total of 254 patients consisting of 127 patients in each treatment arm. The eradication rates of the control and test groups were 65.4% (82/127) and 74.8% (95/127), respectively, in the intention-to-treat analysis (P = .1). In the per-protocol analysis, 70.3% (83/118) and 82.6% (94/115) were eradicated in each group, which was statistically significant (P = .027). The CYP2C19 subtype was examined in 230 patients. The eradication rate was 79.2% (57/72), 75.4% (92/122), and 72.2% (26/36) in each group, which was not significantly different (P = .704). CONCLUSION Ten-day STT was more effective than 7-day STT for HP eradication. The eradication rate was not affected by the CYP2C19 genotype.",2020,"The eradication rate was 79.2% (57/72), 75.4% (92/122), and 72.2% (26/36) in each group, which was not significantly different (","['Helicobacter pylori', '254 patients consisting of 127 patients in each treatment arm', 'patients who were diagnosed with positive results of H pylori examination', '230 patients']","['14-day standard triple therapy (STT', 'clarithromycin', 'amoxicillin', 'ilaprazole-based standard triple therapy']","['eradication rates', 'eradication rate', 'HP eradication rate']","[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C1881129', 'cui_str': 'ilaprazole'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}]",254.0,0.0711825,"The eradication rate was 79.2% (57/72), 75.4% (92/122), and 72.2% (26/36) in each group, which was not significantly different (","[{'ForeName': 'Seung Woo', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul.'}, {'ForeName': 'Sung Jin', 'Initials': 'SJ', 'LastName': 'Moon', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul.'}, {'ForeName': 'Sae Hee', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Division of Gastroenterology Department of Internal Medicine, College of Medicine, Eulji University.'}, {'ForeName': 'Sung Hee', 'Initials': 'SH', 'LastName': 'Jung', 'Affiliation': 'Division of Gastroenterology Department of Internal Medicine, College of Medicine, Eulji University.'}, {'ForeName': 'Kyung Ho', 'Initials': 'KH', 'LastName': 'Song', 'Affiliation': 'Division of Gastroenterology Department of Internal Medicine, College of Medicine, Konyang University.'}, {'ForeName': 'Sun Moon', 'Initials': 'SM', 'LastName': 'Kim', 'Affiliation': 'Division of Gastroenterology Department of Internal Medicine, College of Medicine, Konyang University.'}, {'ForeName': 'Jae Kyu', 'Initials': 'JK', 'LastName': 'Sung', 'Affiliation': 'Division of Gastroenterology Department of Internal Medicine, Chungnam National University School of Medicine, Republic of Korea.'}, {'ForeName': 'Dong Soo', 'Initials': 'DS', 'LastName': 'Lee', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul.'}]",Medicine,['10.1097/MD.0000000000022137'] 1387,32960329,"Transarterial chemoembolization of colorectal cancer liver metastasis: improved tumor response by DSM-TACE versus conventional TACE, a prospective, randomized, single-center trial.","OBJECTIVES To prospectively evaluate the therapy response of third-line TACE with DSM or lipiodol in the treatment of CRLM using MRI. METHODS In this prospective, randomized, single-center trial, patients were randomly assigned to receive TACE therapy with either lipiodol or DSM as the embolization agent. Therapy response was evaluated using MRI. Local tumor response was determined according to RECIST 1.1, and survival data was analyzed using the Kaplan-Meier estimator. RESULTS Fifty patients (35 male, 15 female) were randomized and included in the survival analysis, whereas 31 patients completed therapy and were considered for evaluation of tumor responses (cTACE: n = 13, DSM-TACE: n = 18). In the cTACE group, PR was observed in 23%, SD in 15%, and PD in 62%. In the DSM-TACE-group, PR was observed in 22% of patients, SD in 56%, and PD in 22% (p = 0.047). In addition, the DSM-TACE group showed statistically significant tumor volume reduction (p = 0.006). Median apparent diffusion coefficient values were not significantly different between both groups at baseline (p = 0.26) and study endpoint (p = 0.83). Median survival in the cTACE group was 13 months (95% confidence interval, range 5-40 months) compared to 16 months (95% confidence interval, range 1-48 months) in the DSM-TACE group, exhibiting no statistically significant difference (p = 0.75). CONCLUSION DSM-TACE showed a significant difference reducing tumor volume and in tumor response according to RECIST 1.1 compared to cTACE. Thus, patients with CRLM might not only benefit from short embolization effect of DSM-TACE but also from better tumor responses. Apparent diffusion coefficients were not significantly different between both groups and cannot be used as a biomarker for monitoring for therapeutic effect of TACE. KEY POINTS • To our knowledge, this is the first prospective study that directly compared cTACE and DSM-TACE in patients with CRLM. • DSM-TACE showed a significant difference reducing tumor volume (p = 0.006) and in tumor response according to RECIST 1.1 (p = 0.047) compared to cTACE. • Survival analysis showed a median survival of 13 months in the cTACE group compared to 16 months in the DSM-TACE group (p = 0.75).",2021,DSM-TACE showed a significant difference reducing tumor volume (p = 0.006) and in tumor response according to RECIST 1.1 (p = 0.047) compared to cTACE.,"['colorectal cancer liver metastasis', '31 patients completed therapy and were considered for evaluation of tumor responses (cTACE: n\u2009=\u200913, DSM-TACE: n\u2009=\u200918', 'Fifty patients (35 male, 15 female', 'patients with CRLM']","['DSM-TACE', 'Transarterial chemoembolization', 'TACE therapy with either lipiodol or DSM', 'DSM or lipiodol', 'cTACE', 'DSM-TACE versus conventional TACE', 'cTACE and DSM-TACE']","['Median apparent diffusion coefficient values', 'tumor volume reduction', 'tumor response', 'Median survival', 'survival data', 'tumor volume and in tumor response', 'Local tumor response', 'Therapy response', 'PR', 'tumor volume', 'median survival']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0529196', 'cui_str': 'Tumor Necrosis Factor-alpha Converting Enzyme'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0529196', 'cui_str': 'Tumor Necrosis Factor-alpha Converting Enzyme'}, {'cui': 'C0522522', 'cui_str': 'Transarterial approach'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0947677', 'cui_str': 'Lipiodol UltraFluid'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0475276', 'cui_str': 'Tumor volume'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",,0.0129,DSM-TACE showed a significant difference reducing tumor volume (p = 0.006) and in tumor response according to RECIST 1.1 (p = 0.047) compared to cTACE.,"[{'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Vogl', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60596, Frankfurt, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Marko', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60596, Frankfurt, Germany.'}, {'ForeName': 'Marcel C', 'Initials': 'MC', 'LastName': 'Langenbach', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60596, Frankfurt, Germany.'}, {'ForeName': 'Nagy N N', 'Initials': 'NNN', 'LastName': 'Naguib', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60596, Frankfurt, Germany.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Filmann', 'Affiliation': 'Institute of Biostatistics and Mathematical Modeling, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60596, Frankfurt, Germany.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Hammerstingl', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60596, Frankfurt, Germany.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Gruber-Rouh', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60596, Frankfurt, Germany. tgruberrouh@googlemail.com.'}]",European radiology,['10.1007/s00330-020-07253-2'] 1388,32961410,Intranasal oxytocin and the stress-buffering effects of social support during experimentally induced pain: The role of attachment security.,"BACKGROUND This study examined whether intranasal oxytocin enhances the stress-buffering effects of social support during experimentally induced pain, taking into account the role of individual differences in attachment security. METHODS Female participants (N = 193) were randomly assigned to oxytocin (24 IU intranasal) or placebo and to receive support or no support from a friend (2 × 2 factorial design with repeated measures)). Participants underwent the Cold Pressor Task (CPT) and were monitored for heart rate variability (HRV: RMSSD) and heart rate and reported pain levels. The Experiences in Close Relationships Questionnaire was used to measure attachment. RESULTS Oxytocin reduced RMSSD (p = 0.003, partial ɳ 2  = 0.03) and increased heart rate (p = 0.039, partial ɳ 2  = 0.03) in individuals who received support, possibly reflecting an enhanced attentional state. Oxytocin did not enhance beneficial effects of social support on perceived pain, but increased pain intensity in avoidantly attached individuals who were supported by a friend (p = 0.009, partial ɳ 2  = 0.06). LIMITATIONS Only female participants were examined. Future studies are needed to determine sex differences in how oxytocin shapes stress-buffering effects of support. CONCLUSIONS Oxytocin may enhance the salience of social proximity and may be a mechanism underlying previously reported social influences on cardiovascular and mental health. However, oxytocin effects depend on interpersonal insecurities and may trigger discomfort in avoidantly attached individuals. Caution about oxytocin's therapeutic promise is warranted.",2021,"Oxytocin did not enhance beneficial effects of social support on perceived pain, but increased pain intensity in avoidantly attached individuals who were supported by a friend (p = 0.009, partial ɳ 2  = 0.06). ","['Only female participants', 'Female participants (N\xa0=\xa0193']","['intranasal oxytocin', 'oxytocin', 'placebo and to receive support or no support from a friend', 'Oxytocin', 'Cold Pressor Task (CPT', 'Intranasal oxytocin']","['heart rate variability (HRV: RMSSD) and heart rate and reported pain levels', 'pain intensity', 'RMSSD', 'heart rate', 'pain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",193.0,0.159338,"Oxytocin did not enhance beneficial effects of social support on perceived pain, but increased pain intensity in avoidantly attached individuals who were supported by a friend (p = 0.009, partial ɳ 2  = 0.06). ","[{'ForeName': 'M M E', 'Initials': 'MME', 'LastName': 'Riem', 'Affiliation': 'Behavioural Science Institute, Radboud University, The Netherlands; Department of Clinical Child and Family Studies, VU University, Amsterdam, The Netherlands. Electronic address: m.riem@psych.ru.nl.'}, {'ForeName': 'L E', 'Initials': 'LE', 'LastName': 'Kunst', 'Affiliation': 'Center of Research on Psychological and Somatic disorders, Department of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands; Mentaal Beter, Breda, The Netherlands. Electronic address: L.E.Kunst@tilburguniversity.edu.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Kop', 'Affiliation': 'Center of Research on Psychological and Somatic disorders, Department of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands. Electronic address: W.J.Kop@tilburguniversity.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.057'] 1389,32948867,"Effects of whey protein and dietary fiber intake on insulin sensitivity, body composition, energy expenditure, blood pressure, and appetite in subjects with abdominal obesity.","BACKGROUND Recently, we demonstrated that whey protein (WP) combined with low dietary fiber improved lipemia, a risk factor for cardiovascular disease in subjects with abdominal obesity. In the present study, we investigated the effects of intake of WP and dietary fiber from enzyme-treated wheat bran on other metabolic parameters of the metabolic syndrome. METHODS The study was a 12-week, double-blind, randomized, controlled, parallel intervention study. We randomized 73 subjects with abdominal obesity to 1 of 4 iso-energetic dietary interventions: 60 g per day of either WP hydrolysate or maltodextrin (MD) combined with high-fiber (HiFi; 30 g dietary fiber/day) or low-fiber (LoFi; 10 g dietary fiber/day) cereal products. We assessed changes in insulin sensitivity, gut hormones (GLP-1, GLP-2, GIP, and peptide YY), body composition, 24-h BP, resting energy expenditure and respiratory exchange ratio (RER), and appetite. RESULTS Sixty-five subjects completed the trial. Subjective hunger ratings were lower after 12 weeks of WP compared with MD, independent of fiber content (P = 0.02). We found no effects on ratings of satiety, fullness or prospective food consumption for either of the interventions. Intake of WP combined with LoFi increased the postprandial peptide YY response. There were no effects of WP or fiber on insulin sensitivity, body composition, energy expenditure, incretins, or 24-h BP. CONCLUSIONS WP consumption for 12 weeks reduced subjective ratings of hunger in subjects with abdominal obesity. Neither WP nor dietary fiber from wheat bran affected insulin sensitivity, 24-h BP, gut hormone responses, body composition, or energy expenditure compared with MD and low dietary fiber.",2021,"Subjective hunger ratings were lower after 12 weeks of WP compared with MD, independent of fiber content (P = 0.02).","['subjects with abdominal obesity', 'Sixty-five subjects completed the trial', '73 subjects with abdominal obesity to 1 of 4 iso-energetic dietary interventions']","['WP consumption', 'whey protein (WP) combined with low dietary fiber improved lipemia', 'WP combined with LoFi', 'WP hydrolysate or maltodextrin (MD) combined with high-fiber (HiFi; 30\u2009g dietary fiber/day) or low-fiber (LoFi; 10\u2009g dietary fiber/day) cereal products', 'whey protein and dietary fiber intake', 'WP and dietary fiber from enzyme-treated wheat bran']","['WP or fiber on insulin sensitivity, body composition, energy expenditure, incretins, or 24-h BP', 'postprandial peptide YY response', 'insulin sensitivity, 24-h BP, gut hormone responses, body composition, or energy expenditure', 'insulin sensitivity, gut hormones (GLP-1, GLP-2, GIP, and peptide YY), body composition, 24-h BP, resting energy expenditure and respiratory exchange ratio (RER), and appetite', 'insulin sensitivity, body composition, energy expenditure, blood pressure, and appetite', 'subjective ratings of hunger', 'ratings of satiety, fullness or prospective food consumption', 'Subjective hunger ratings']","[{'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C0474451', 'cui_str': 'Dietary fiber intake'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0043138', 'cui_str': 'Wheat bran'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C1562292', 'cui_str': 'Incretin'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0912332', 'cui_str': 'Glucagon-like peptide 2'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",73.0,0.0563907,"Subjective hunger ratings were lower after 12 weeks of WP compared with MD, independent of fiber content (P = 0.02).","[{'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Fuglsang-Nielsen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark. rasmusfuglsang@gmail.com.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Rakvaag', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Langdahl', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Knud Erik Bach', 'Initials': 'KEB', 'LastName': 'Knudsen', 'Affiliation': 'Department of Animal Science, Aarhus University, Tjele, Denmark.'}, {'ForeName': 'Bolette', 'Initials': 'B', 'LastName': 'Hartmann', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens Juul', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Kjeld', 'Initials': 'K', 'LastName': 'Hermansen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Gregersen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}]",European journal of clinical nutrition,['10.1038/s41430-020-00759-4'] 1390,32951215,Disability Prevention Program Improves Life-Space and Falls Efficacy: A Randomized Controlled Trial.,"OBJECTIVES To evaluate the effects of a home-based disability prevention program on life-space and falls efficacy among low-income older adults. DESIGN Single-blind two-arm randomized controlled trial. SETTING Participants' homes. PARTICIPANTS Participants were low-income cognitively intact older adults (≥65 years old) with restricted daily activities. Our analytic sample for life-space (n = 194) and falls efficacy (n = 233) varied as the life-space measure was introduced 4 months after the trial began. INTERVENTION Up to six 1-hour home visits with an occupational therapist; up to four 1-hour home visits with a registered nurse; and up to $1,300 worth of home repairs, modifications, and assistive devices with a handyman, during a course of 4 months. MEASUREMENTS Life-space was measured by the Homebound Mobility Assessment; falls efficacy was measured using the 10-item Tinetti Falls Efficacy Scale at baseline and 5 months. RESULTS Participants were on average 75 years old, predominantly Black (86%) and female (85%-86%). Compared with participants in the control group, participants receiving the intervention were more likely to have improved versus decreased life-space in areas of bathroom (adjusted odds ratio (OR) = 3.95; 95% confidence interval (CI) = 1.20-12.97), front or back porch, patio, or deck (adjusted OR = 2.67; 95% CI = 1.05-6.79), stairs (adjusted OR = 4.09; 95% CI = 1.34-12.48), leaving the house for any reason other than for health care (adjusted OR = 2.40; 95% CI = 1.01-5.73), and overall life-space (adjusted OR = 2.15; 95% CI = 1.10-4.19). Participants who received the intervention also had an 11% improvement in falls efficacy in performing daily activities (exponentiated coefficient = 1.12; 95% CI = 1.04-1.21). CONCLUSION Life-space and falls efficacy were improved through a multicomponent, person-directed, home-based disability prevention intervention. Findings suggest that this intervention should be translated into different settings to promote independent aging.",2021,"Compared with participants in the control group, participants receiving the intervention were more likely to have improved versus decreased life-space in areas of bathroom (adjusted odds ratio (OR) = ","['low-income older adults', ""Participants' homes"", 'Participants were on average 75\u2009years old, predominantly Black (86%) and female (85%-86', 'Participants were low-income cognitively intact older adults (≥65\u2009years old) with restricted daily activities']","['home-based disability prevention program', 'Up to six 1-hour home visits with an occupational therapist; up to four 1-hour home visits with a registered nurse; and up to $1,300 worth of home repairs, modifications, and assistive devices with a handyman']","['Life-Space and Falls Efficacy', 'falls efficacy', '10-item Tinetti Falls Efficacy Scale', 'overall life-space', 'Homebound Mobility Assessment; falls efficacy', 'life-space and falls efficacy', 'Life-space']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0028807', 'cui_str': 'Occupational therapist'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0036605', 'cui_str': 'Assistive equipment'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2584445', 'cui_str': 'Tinetti falls efficacy scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242798', 'cui_str': 'Home-Bound Persons'}, {'cui': 'C2317515', 'cui_str': 'Assessment of mobility'}]",,0.137717,"Compared with participants in the control group, participants receiving the intervention were more likely to have improved versus decreased life-space in areas of bathroom (adjusted odds ratio (OR) = ","[{'ForeName': 'Minhui', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Central South University Xiangya School of Nursing, Changsha, China.'}, {'ForeName': 'Qian-Li', 'Initials': 'QL', 'LastName': 'Xue', 'Affiliation': 'Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Laura N', 'Initials': 'LN', 'LastName': 'Gitlin', 'Affiliation': 'Johns Hopkins University School of Nursing, Baltimore, Maryland, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Wolff', 'Affiliation': 'Department of Health Policy and Management, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Guralnik', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Leff', 'Affiliation': 'Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Szanton', 'Affiliation': 'Johns Hopkins University School of Nursing, Baltimore, Maryland, USA.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16808'] 1391,32956698,"Growth from Birth Through Six Months for Infants of Mothers in the ""Women First"" Preconception Maternal Nutrition Trial.","OBJECTIVE To evaluate whether the fetal linear growth effects of maternal nutrition supplementation would be maintained through 6 months postnatal age. STUDY DESIGN The Women First trial was a multicountry, individually randomized clinical trial that compared the impact of maternal nutrition supplementation initiated preconception (Arm 1) vs at ∼11 weeks of gestation (Arm 2), vs no supplement (Arm 3); the intervention was discontinued at delivery. Trial sites were in Democratic Republic of Congo, Guatemala, India, and Pakistan. Analysis includes 2421 infants born to 2408 randomized women. Primary outcome was the trajectory of length-for-age z scores (LAZ) by arm, based on assessments at birth and 1, 3, and 6 months. We fitted longitudinal models on growth from birth to 6 months using generalized estimating equations; maternal intervention effects were evaluated, adjusting for site and baseline maternal covariates. RESULTS Linear growth for Arms 1 and 2 was statistically greater than for Arm 3 in 3 of the 4 countries, with average pairwise mean differences in LAZ of 0.25 (95% CI 0.15-0.35; P < .001) and 0.19 (95% CI 0.09-0.28; P < .001), respectively. Compared with Arm 3, average overall adjusted relative risks (95% CI) for stunting (LAZ <-2) were lower for Arms 1 and 2: 0.76 (0.66-0.87; P < .001) and 0.77 (0.67-0.88; P < .001), respectively. CONCLUSIONS Improved linear growth in early infancy observed for the 2 intervention arms supports the critical importance of maternal nutrition before conception and in the early phase of gestation. TRIAL REGISTRATION ClinicalTrials.gov: NCT01883193.",2021,"RESULTS Linear growth for Arms 1 and 2 was statistically greater than for Arm 3 in 3 of the 4 countries, with average pairwise mean differences in LAZ of 0.25 (95% CI, 0.15,0.35; P < .001) and 0.19 (95% CI, 0.09,0.28; P<0.001), respectively.",['2421 infants born to 2408 randomized women'],"['maternal nutrition supplementation initiated preconception', 'maternal nutrition supplementation']",['trajectory of length-for-age Z-scores (LAZ'],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1720845', 'cui_str': 'Maternal Nutritional Physiological Phenomenon'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",2408.0,0.359219,"RESULTS Linear growth for Arms 1 and 2 was statistically greater than for Arm 3 in 3 of the 4 countries, with average pairwise mean differences in LAZ of 0.25 (95% CI, 0.15,0.35; P < .001) and 0.19 (95% CI, 0.09,0.28; P<0.001), respectively.","[{'ForeName': 'Nancy F', 'Initials': 'NF', 'LastName': 'Krebs', 'Affiliation': 'University of Colorado School of Medicine, Denver, CO.'}, {'ForeName': 'K Michael', 'Initials': 'KM', 'LastName': 'Hambidge', 'Affiliation': 'University of Colorado School of Medicine, Denver, CO.'}, {'ForeName': 'Jamie L', 'Initials': 'JL', 'LastName': 'Westcott', 'Affiliation': 'University of Colorado School of Medicine, Denver, CO.'}, {'ForeName': 'Ana L', 'Initials': 'AL', 'LastName': 'Garcés', 'Affiliation': 'Institute of Nutrition in Central America and Panama (INCAP), Guatemala City, Guatemala.'}, {'ForeName': 'Lester', 'Initials': 'L', 'LastName': 'Figueroa', 'Affiliation': 'Institute of Nutrition in Central America and Panama (INCAP), Guatemala City, Guatemala.'}, {'ForeName': 'Antoinette K', 'Initials': 'AK', 'LastName': 'Tsefu', 'Affiliation': 'Kinshasa School of Public Health, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Adrien L', 'Initials': 'AL', 'LastName': 'Lokangaka', 'Affiliation': 'Kinshasa School of Public Health, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Shivaprasad S', 'Initials': 'SS', 'LastName': 'Goudar', 'Affiliation': ""KLE Academy of Higher Education and Research's Jawaharlal Nehru Medical College, Belagavi, India.""}, {'ForeName': 'Sangappa M', 'Initials': 'SM', 'LastName': 'Dhaded', 'Affiliation': ""KLE Academy of Higher Education and Research's Jawaharlal Nehru Medical College, Belagavi, India.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Saleem', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Sumera Aziz', 'Initials': 'SA', 'LastName': 'Ali', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Carl L', 'Initials': 'CL', 'LastName': 'Bose', 'Affiliation': 'University of North Carolina, Raleigh, NC.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Derman', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Goldenberg', 'Affiliation': 'Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Vanessa R', 'Initials': 'VR', 'LastName': 'Thorsten', 'Affiliation': 'RTI International, Durham, NC.'}, {'ForeName': 'Amaanti', 'Initials': 'A', 'LastName': 'Sridhar', 'Affiliation': 'RTI International, Durham, NC.'}, {'ForeName': 'Dhuly', 'Initials': 'D', 'LastName': 'Chowdhury', 'Affiliation': 'RTI International, Durham, NC.'}, {'ForeName': 'Abhik', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'RTI International, Durham, NC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.09.032'] 1392,32961528,A Randomized Controlled Trial of Prasugrel for Prevention of Early Saphenous Vein Graft Thrombosis.,"OBJECTIVES To test whether administration of prasugrel after coronary artery bypass grafting (CABG) reduces saphenous vein graft (SVG) thrombosis. Use of aspirin after CABG improves graft patency, but administration of other antiplatelet agents has yielded equivocal results. METHODS We performed a double-blind trial randomizing patients to prasugrel or placebo after CABG at four United States centers. Almost all patients were receiving aspirin. Follow-up angiography, optical coherence tomography (OCT), intravascular ultrasound (IVUS), and near-infrared spectroscopy (NIRS) were performed at 12 months. The primary efficacy endpoint was prevalence of OCT-detected SVG thrombus. The primary safety endpoint was incidence of Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO) severe bleeding. RESULTS The study was stopped early due to slow enrollment after randomizing 84 patients. Mean age was 64 ± 6 years; 98% of the patients were men. Follow-up angiography was performed in 59 patients. IVUS was performed in 52 patients, OCT in 53 patients, and NIRS in 33 patients. Thrombus was identified by OCT in 56% vs 50% of patients in the prasugrel vs placebo groups, respectively (P=.78). Angiographic SVG failure occurred in 24% of patients in the prasugrel arm vs 40% in the placebo arm (P=.19). The 1-year incidence of major adverse cardiovascular events was 14.3% vs 2.4% in the prasugrel and placebo groups, respectively (P=.20), without significant differences in GUSTO severe bleeding (P=.32). CONCLUSION Early SVG failure occurred in approximately one-third of patients. Prasugrel did not decrease prevalence of SVG thrombus 12 months after CABG.",2020,Angiographic SVG failure occurred in 24% of patients in the prasugrel arm vs 40% in the placebo arm (P=.19).,"['after CABG at four United States centers', '59 patients', 'Mean age was 64 ± 6 years; 98% of the patients were men', 'Early Saphenous Vein Graft Thrombosis']","['prasugrel after coronary artery bypass grafting (CABG', 'IVUS', 'prasugrel or placebo', 'Follow-up angiography, optical coherence tomography (OCT), intravascular ultrasound (IVUS), and near-infrared spectroscopy (NIRS', 'placebo', 'Prasugrel', 'aspirin']","['Angiographic SVG failure', 'saphenous vein graft (SVG) thrombosis', '1-year incidence of major adverse cardiovascular events', 'GUSTO severe bleeding', 'graft patency', 'prevalence of OCT-detected SVG thrombus', 'Early SVG failure', 'incidence of Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO) severe bleeding']","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0729538', 'cui_str': 'Saphenous vein graft'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}]","[{'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0729538', 'cui_str': 'Saphenous vein graft'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0038418', 'cui_str': 'Streptokinase'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",59.0,0.37887,Angiographic SVG failure occurred in 24% of patients in the prasugrel arm vs 40% in the placebo arm (P=.19).,"[{'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Danek', 'Affiliation': ''}, {'ForeName': 'Aris', 'Initials': 'A', 'LastName': 'Karatasakis', 'Affiliation': ''}, {'ForeName': 'Kazeen', 'Initials': 'K', 'LastName': 'Abdullah', 'Affiliation': ''}, {'ForeName': 'Rahel', 'Initials': 'R', 'LastName': 'Iwnetu', 'Affiliation': ''}, {'ForeName': 'Pratik', 'Initials': 'P', 'LastName': 'Kalsaria', 'Affiliation': ''}, {'ForeName': 'Kendrick', 'Initials': 'K', 'LastName': 'Shunk', 'Affiliation': ''}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Zimmet', 'Affiliation': ''}, {'ForeName': 'Mladen', 'Initials': 'M', 'LastName': 'Vidovich', 'Affiliation': ''}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Bavry', 'Affiliation': ''}, {'ForeName': 'Bavana V', 'Initials': 'BV', 'LastName': 'Rangan', 'Affiliation': ''}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Roesle', 'Affiliation': ''}, {'ForeName': 'Decebal', 'Initials': 'D', 'LastName': 'Griza', 'Affiliation': ''}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Stanley', 'Affiliation': ''}, {'ForeName': 'Subhash', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': ''}, {'ForeName': 'Houman', 'Initials': 'H', 'LastName': 'Khalili', 'Affiliation': ''}, {'ForeName': 'Emmanouil S', 'Initials': 'ES', 'LastName': 'Brilakis', 'Affiliation': ''}, {'ForeName': 'Shuaib M', 'Initials': 'SM', 'LastName': 'Abdullah', 'Affiliation': 'Shuaib Abdullah, MD, Veterans Affairs North Texas Health Care System, 4500 South Lancaster, 111A, Dallas, TX 75216 USA. shuaib.abdullah@utsouthwestern.edu.'}]",The Journal of invasive cardiology,[] 1393,32961529,Randomized COmparison of Isolated Radial Artery ComPrEssioN Versus Radial and Ipsilateral Ulnar Artery Compression in Achieving Radial Artery Patency: The OPEN-Radial Trial.,"BACKGROUND Radial artery occlusion (RAO) occurs after transradial access (TRA), limiting future ipsilateral access. Pragmatic RAO-lowering strategies need to be developed. METHODS Patients undergoing transradial cardiac catheterization were randomized to receive postprocedural hemostasis with either a single-bladder radial compression band (group 1) or a double-balloon band capable of simultaneous ipsilateral ulnar artery compression (group 2). Hemostatic compression was performed for 120 minutes. Patients in group 2 received ipsilateral ulnar artery compression for the first 60 minutes of radial hemostasis. The primary endpoint of the study was achievement of patent hemostasis, defined as radial artery patency at 15 minutes after onset of hemostatic compression. Radial artery patency was measured at 15 minutes, 60 minutes, 90 minutes, and 120 minutes after onset of compression and 1 hour after removal of the compression bands. RESULTS A total of 253 patients were randomized (127 in group 1 and 126 in group 2). Patent hemostasis was achieved significantly more frequently in group 2 vs group 1 (96.8% vs 74.8%, respectively; P<.001). RAO at 1 hour post band removal was significantly lower in group 2 vs group 1 (1.6% vs 10.2%, respectively; P<.001). Rebound bleeding occurred less frequently in group 2 vs group 1 (1.6% vs 7.9%, respectively; P=.03). CONCLUSION Ipsilateral ulnar compression performed for the initial 1 hour during the radial hemostatic process after TRA using a dedicated double-balloon device is associated with higher rates of patent hemostasis and lower incidence of RAO compared with a single-balloon band.",2020,"Patent hemostasis was achieved significantly more frequently in group 2 vs group 1 (96.8% vs 74.8%, respectively; P<.001).","['Patients undergoing transradial cardiac catheterization', '253 patients']","['ipsilateral ulnar artery compression', 'postprocedural hemostasis with either a single-bladder radial compression band (group 1) or a double-balloon band capable of simultaneous ipsilateral ulnar artery compression', 'Isolated Radial Artery ComPrEssioN Versus Radial and Ipsilateral Ulnar Artery Compression']","['Radial artery patency', 'Patent hemostasis', 'Rebound bleeding', 'achievement of patent hemostasis, defined as radial artery patency', 'Hemostatic compression', 'RAO']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018795', 'cui_str': 'Cardiac catheterization'}]","[{'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0162858', 'cui_str': 'Structure of ulnar artery'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}]","[{'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0030650', 'cui_str': 'Patents'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}]",253.0,0.215156,"Patent hemostasis was achieved significantly more frequently in group 2 vs group 1 (96.8% vs 74.8%, respectively; P<.001).","[{'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Patel', 'Affiliation': ''}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Shah', 'Affiliation': ''}, {'ForeName': 'Bhavin A', 'Initials': 'BA', 'LastName': 'Patel', 'Affiliation': ''}, {'ForeName': 'Tejas M', 'Initials': 'TM', 'LastName': 'Patel', 'Affiliation': 'Apex Heart Institute, Ahmedabad, India. tejaspatel@apexheart.in.'}]",The Journal of invasive cardiology,[] 1394,32969541,"Internet-based therapy versus face-to-face therapy for alcohol use disorder, a randomized controlled non-inferiority trial.","BACKGROUND AND AIMS Most people with alcohol use disorder (AUD) are never treated. Internet-based interventions are effective in reducing alcohol consumption and could help to overcome some of the barriers to people not seeking or receiving treatment. The aim of the current study was to compare internet-delivered and face-to-face treatment among adult users with AUD. DESIGN Randomized controlled non-inferiority trial with a parallel design, comparing internet-delivered cognitive-behavioural therapy (ICBT) (n = 150) with face-to-face CBT (n = 151), at 3- and 6-month follow-ups. SETTING A specialized clinic for people with AUD in Stockholm, Sweden. Participants were recruited between 8 December 2015 and 5 January 2018. PARTICIPANTS A total of 301 patients [mean age 50 years, standard deviation (SD) = 12.3] with AUD, of whom 115 (38%) were female and 186 (62%) were male. INTERVENTION AND COMPARATOR Participants were randomized in blocks of 20 at a ratio of 1 : 1 to five modules of therapist-guided ICBT or to five modules of face-to-face CBT, delivered over a 3-month period. The same treatment material and the same therapists were used in both groups. MEASUREMENTS The primary outcome was standard drinks of alcohol consumed during the previous week at 6-month follow-up, analysed according to intention-to-treat. The pre-specified non-inferiority limit was five standard drinks of alcohol and d = 0.32 for secondary outcomes. RESULTS The difference in alcohol consumption between the internet and the face-to-face group was non-inferior in the intention-to-treat analysis of data from the 6-month follow-up [internet = 12.33 and face-to-face = 11.43, difference = 0.89, 95% confidence interval (CI) = -1.10 to 2.88]. The secondary outcome, Alcohol Use Disorder Identification Test score, failed to show non-inferiority of internet compared with face-to-face in the intention-to-treat analysis at 6-month follow-up (internet = 12.26 and face-to-face = 11.57, d = 0.11, 95% CI = -0.11 to 0.34). CONCLUSIONS Internet-delivered treatment was non-inferior to face-to-face treatment in reducing alcohol consumption among help-seeking patients with alcohol use disorder but failed to show non-inferiority on some secondary outcomes.",2021,"The difference in alcohol consumption between the internet and the face-to-face group was non-inferior in the intention-to-treat analysis of data from the six-month follow-up (internet=12.33 and face-to-face=11.43,","['Participants were recruited between 8 December, 2015, and 5 January, 2018', 'adult users with AUD', 'people with alcohol use disorder (AUD', 'A specialized clinic for people with AUD in Stockholm, Sweden', '301 patients (mean age 50 years [SD 12.3]) with AUD, of whom 115 (38%) were female and 186 (62%) were male']","['internet-delivered cognitive-behavioural therapy (ICBT) (n=150) with face-to-face CBT', 'therapist-guided ICBT or to five modules of face-to-face CBT', 'Internet-based therapy vs. face-to-face therapy']","['alcohol consumption', 'standard drinks of alcohol', 'Alcohol Use Disorder Identification Test score, failed to show non-inferiority of internet compared with face-to-face in the intention-to-treat analysis']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191283', 'cui_str': '12.3'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C2732658', 'cui_str': 'Alcohol use disorders identification test score'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]",,0.0935829,"The difference in alcohol consumption between the internet and the face-to-face group was non-inferior in the intention-to-treat analysis of data from the six-month follow-up (internet=12.33 and face-to-face=11.43,","[{'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Johansson', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Sinadinovic', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Gajecki', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Lindner', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anne H', 'Initials': 'AH', 'LastName': 'Berman', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ulric', 'Initials': 'U', 'LastName': 'Hermansson', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Andréasson', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}]","Addiction (Abingdon, England)",['10.1111/add.15270'] 1395,32969563,Cabozantinib plus docetaxel and prednisone in metastatic castration-resistant prostate cancer.,"OBJECTIVE To evaluate the safety and efficacy of cabozantinib combined with docetaxel. PATIENTS AND METHODS This was a phase 1/2 multicentre study in patients with metastatic castration-resistant prostate cancer (mCRPC). Docetaxel (75 mg/m 2 every 3 weeks with daily prednisone 10 mg) was combined with escalating doses of daily cabozantinib (20, 40 and 60 mg). Based on the results of the phase 1 study, the investigation was expanded into a randomized study of docetaxel with prednisone (hereafter 'docetaxel/prednisone') plus the maximum tolerated dose (MTD) of cabozantinib compared with docetaxel/prednisone alone. RESULTS A total of 44 men with mCRPC were enrolled in this phase 1/2 trial. An MTD of 40 mg cabozantinib plus docetaxel/prednisone was determined. Dose-limiting toxicities were neutropenic fever and palmar-plantar erythrodysesthesia, and there was one death attributable to a thromboembolic event. In addition, grade 3 or 4 myelosuppression, hypophosphataemia and neuropathy were seen in three or more patients. In the phase 1 study, the median time to progression (TTP) and overall survival (OS) time were 13.6 and 16.3 months, respectively. In the phase 2 study, which was terminated early because of poor accrual, the median TTP and OS favoured the combination (n = 13) compared to docetaxel/prednisone alone (n = 12; 21.0 vs 6.6 months; P = 0.035 and 23.8 vs 15.6 months; P = 0.072, respectively). CONCLUSION Despite the limited number of patients in this study, preliminary data suggest that cabozantinib can be safely added to docetaxel/prednisone with possible enhanced efficacy.",2021,Dose limiting toxicities were neutropenic fever and palmer-plantar erythrodysesthesia and there was 1 death due to a thromboembolic event.,"['Metastatic Castrate Resistant Prostate Cancer', 'patients with mCRPC', '44 men with mCRPC']","['cabozantinib vs. docetaxel/prednisone', 'Cabozantinib plus Docetaxel and Prednisone', 'cabozantinib combined with docetaxel', 'docetaxel', 'Docetaxel', 'docetaxel/prednisone']","['median time to progression (TTP) and overall survival', 'median TTP and overall survival', 'neutropenic fever and palmer-plantar erythrodysesthesia', 'safety and efficacy', 'grade 3 or 4 myelosuppression, hypophosphatemia, and neuropathy']","[{'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0230373', 'cui_str': 'Palm of hand (surface region)'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression'}, {'cui': 'C0085682', 'cui_str': 'Hypophosphatemia'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}]",44.0,0.0319574,Dose limiting toxicities were neutropenic fever and palmer-plantar erythrodysesthesia and there was 1 death due to a thromboembolic event.,"[{'ForeName': 'Ravi A', 'Initials': 'RA', 'LastName': 'Madan', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Fatima H', 'Initials': 'FH', 'LastName': 'Karzai', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Munjid', 'Initials': 'M', 'LastName': 'Al Harthy', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Petrylak', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Arlen', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Rosner', 'Affiliation': 'Center for Prostate Disease Research, Walter Reed National Military Medical Center, Bethesda, MD, USA.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Theoret', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Cordes', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Marijo', 'Initials': 'M', 'LastName': 'Bilusic', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Cody J', 'Initials': 'CJ', 'LastName': 'Peer', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Dawson', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Washington, DC, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Couvillon', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Hankin', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Moniquea', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Guin', 'Initials': 'G', 'LastName': 'Chun', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Owens', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Marte', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Min-Jung', 'Initials': 'MJ', 'LastName': 'Lee', 'Affiliation': 'Developmental Therapeutics Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Tomita', 'Affiliation': 'Developmental Therapeutics Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Yuno', 'Affiliation': 'Developmental Therapeutics Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Jane B', 'Initials': 'JB', 'LastName': 'Trepel', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Sunmin', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Developmental Therapeutics Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Seth M', 'Initials': 'SM', 'LastName': 'Steinberg', 'Affiliation': 'Biostatistics and Data Management Section, Center for Cancer Research, NCI, Bethesda, MD, USA.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Gulley', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Figg', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Dahut', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}]",BJU international,['10.1111/bju.15227'] 1396,32966558,Results of a Feasibility Study of Helpers Stay Quit Training for Smoking Relapse Prevention.,"INTRODUCTION Most smoking quit attempts end in relapse, and interventions focused on relapse prevention are lacking. Helpers Stay Quit (HSQ) is a novel behavioral relapse prevention intervention that teaches newly abstinent smokers to offer a ""helping conversation"" (HC) to help others quit tobacco. METHODS Pre-post intervention feasibility study with state quitline participants ≥14 days abstinent. Measures at baseline, 3 months, and 6 months included smoking status, offering HCs, and cessation self-efficacy. Primary outcomes: self-reported 7-day point prevalence abstinence; offering HCs. Cox models explored association of HCs with relapse. Preliminary effects analysis using propensity score matching compared 30-day abstinence of quitline clients with study sample at 7 months. RESULTS Participants (N = 104) were as follows: mean age of 53 years (SD 13.9 years), 48.1% male, mean of cigarettes smoked/day of 16.2 (SD 9.7). Compared with participants who remained abstinent (n = 82), relapsers (n = 22) had fewer HCs over 6 months (2.6 vs 7.2; 95% confidence interval [CI]: 1.4, 7.8, p = .006). Using adjusted Cox regression, the hazard ratio of relapse for each HC was 0.85 (95% CI: 0.74, 0.99, p = .03). Compared with a matched sample of quitline clients not exposed to HSQ, study participants were 49% more likely to report 30-day abstinence at 7-month quitline follow-up (95% CI: 40%, 59%, p < .0001). CONCLUSIONS HSQ, delivered to newly abstinent smokers who received standard quitline treatment, was associated with less self-reported relapse. These promising preliminary study results warrant further research to evaluate HSQ as a novel behavioral intervention to prevent smoking relapse. IMPLICATIONS To date, behavioral interventions for smoking relapse prevention that teach abstainers cessation skills to apply to themselves have not shown effectiveness. This feasibility study examines the preliminary efficacy of a conceptually novel, ""help others"" behavioral intervention approach for relapse prevention in newly abstinent smokers recruited from a state quitline. HSQ teaches the newly abstinent smoker communication and listening skills to encourage other smokers in their personal social network to quit. Exploratory analysis using propensity score matching suggests that participants exposed to HSQ were significantly more likely to self-report 30-day abstinence at quitline 7-month follow-up than other quitline clients.",2021,"Compared to participants who remained abstinent (n=82), relapsers (n=22) had fewer HCs over 6 months (2.6 vs. 7.2","['newly abstinent smokers recruited from a state quitline', 'Participants (N=104) were: mean age of 53 years (SD 13.9 years), 48.1% male, mean of cigarettes smoked/day of 16.2 (SD 9.7', 'quitline clients with study sample at', 'state quitline participants ≥ 14 days abstinent']","['standard quitline treatment', 'Helpers Stay Quit Training', 'conceptually novel, ""help others"" behavioral intervention approach']","['self-reported 7-day point prevalence abstinence; offering HCs', 'Helpers Stay Quit teaches', 'hazard ratio of relapse', 'self-report 30-day abstinence', '30-day abstinence', 'smoking status, offering of HCs, and cessation self-efficacy', 'Helpers Stay Quit (HSQ']","[{'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517562', 'cui_str': '13.9'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4319690', 'cui_str': '16.2'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0032052', 'cui_str': 'Human placental lactogen'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",104.0,0.0233105,"Compared to participants who remained abstinent (n=82), relapsers (n=22) had fewer HCs over 6 months (2.6 vs. 7.2","[{'ForeName': 'Myra L', 'Initials': 'ML', 'LastName': 'Muramoto', 'Affiliation': 'Department of Family and Community Medicine, College of Medicine-Tucson, University of Arizona, Tucson, AZ.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Hopkins', 'Affiliation': 'Department of Anthropology, Texas A&M University, College Station, TX.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Bell', 'Affiliation': 'Department of Epidemiology and Biostatistics, Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Allen', 'Affiliation': 'Department of Family and Community Medicine, College of Medicine-Tucson, University of Arizona, Tucson, AZ.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Nair', 'Affiliation': 'Department of Family and Community Medicine, College of Medicine-Tucson, University of Arizona, Tucson, AZ.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': 'Connolly', 'Affiliation': 'Department of Family and Community Medicine, College of Medicine-Tucson, University of Arizona, Tucson, AZ.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa176'] 1397,32968936,Effectiveness of Atorvastatin in the Treatment of Asymptomatic Heart Failure After Myocardial Infarction: A Clinical Study.,"INTRODUCTION Silent heart failure after myocardial infarction has not been effectively treated. Atorvastatin has certain efficacy in the treatment of heart failure. Our clinical study aimed to investigate the effectiveness of atorvastatin in patients with asymptomatic heart failure after myocardial infarction. METHODS A total of 162 patients with asymptomatic heart failure after myocardial infarction in our hospital from August 2018 to August 2019 were randomly divided into the observation group (81 cases were treated with atorvastatin on the basis of routine therapy) and the control group (81 cases were treated with routine symptomatic treatment). The clinical curative effect, the level of related inflammatory cytokines, cardiac function index, and vascular endothelial function were compared between the two groups. RESULTS Before intervention, there was no significant difference in tumor necrosis factor (TNFα), high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), plasma N-terminal B-type natriuretic peptide (NT-ProBNP), left ventricular ejection fraction (LVEF), left ventricular end diastolic diameter (LVEDD), left ventricular end systolic diameter (LVESD), left ventricular posterior wall thickness (LVPWT), asymmetric dimethyarginine (ADMA), activity of nitric oxide synthase (NOS), nitric oxide (NO) and flow-mediated dilation (FMD) between the two groups. After intervention, TNFα, hs-CRP, IL-6, NT-ProBNP, LVEF, LVEDD, LVESD, LVPWT, ADMA, NOS, NO, and FMD were improved in both groups. The clinical curative effect, TNFα, hs-CRP, IL-6, NT-ProBNP, LVEF, LVEDD, LVESD, LVPWT, ADMA, NOS, NO, and FMD in the observation group showed significantly greater results than those in the control group (P < 0.05). CONCLUSION Atorvastatin exerted a great effect in treating asymptomatic heart failure after myocardial infarction, which can evidently reduce the level of related inflammatory cytokines, improve cardiac function, and regulate vascular endothelial function. Hence, atorvastatin is considered a valid and alternative approach in clinical practice.",2020,"After intervention, TNFα, hs-CRP, IL-6, NT-ProBNP, LVEF, LVEDD, LVESD, LVPWT, ADMA, NOS, NO, and FMD were improved in both groups.","['Asymptomatic Heart Failure', 'heart failure', 'After Myocardial Infarction', 'patients with asymptomatic heart failure after myocardial infarction', '162 patients with asymptomatic heart failure after myocardial infarction in our hospital from August 2018 to August 2019']","['Atorvastatin', 'atorvastatin']","['clinical curative effect, TNFα, hs-CRP, IL-6, NT-ProBNP, LVEF, LVEDD, LVESD, LVPWT, ADMA, NOS, NO, and FMD', 'level of related inflammatory cytokines, cardiac function index, and vascular endothelial function', 'TNFα, hs-CRP, IL-6, NT-ProBNP, LVEF, LVEDD, LVESD, LVPWT, ADMA, NOS, NO, and FMD', 'tumor necrosis factor (TNFα), high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), plasma N-terminal B-type natriuretic peptide (NT-ProBNP), left ventricular ejection fraction (LVEF), left ventricular end diastolic diameter (LVEDD), left ventricular end systolic diameter (LVESD), left ventricular posterior wall thickness (LVPWT), asymmetric dimethyarginine (ADMA), activity of nitric oxide synthase (NOS), nitric oxide (NO) and flow-mediated dilation (FMD']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0227701', 'cui_str': 'Structure of posterior wall of urinary bladder'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0067385', 'cui_str': 'N,N-dimethylarginine'}, {'cui': 'C0132555', 'cui_str': 'Nitric-oxide synthase'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",162.0,0.0159963,"After intervention, TNFα, hs-CRP, IL-6, NT-ProBNP, LVEF, LVEDD, LVESD, LVPWT, ADMA, NOS, NO, and FMD were improved in both groups.","[{'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Bai', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Xiao-Ran', 'Initials': 'XR', 'LastName': 'Cui', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Xiao-Hong', 'Initials': 'XH', 'LastName': 'Yang', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China. 13933058601@163.com.'}, {'ForeName': 'Ji-Dong', 'Initials': 'JD', 'LastName': 'Zhang', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}]",Advances in therapy,['10.1007/s12325-020-01441-8'] 1398,32955672,Does the Length of the Common Channel as Part of the Total Alimentary Tract Matter? One Year Results from the Multicenter Dutch Common Channel Trial (DUCATI) Comparing Standard Versus Distal Roux-en-Y Gastric Bypass with Similar Biliopancreatic Bowel Limb Lengths.,"PURPOSE Although the laparoscopic Roux-en-Y Gastric Bypass (LRYGB) is the gold-standard bariatric procedure, it remains uncertain what the optimal bowel limb lengths are to accomplish maximal weight loss while minimizing nutritional deficiencies and related gastro-intestinal complaints. The aim of this randomized controlled multicenter trial is to investigate the effect of significant lengthening of the length of the Roux limb (RL) at the cost of the length of the common channel (CC) while keeping the biliopancreatic limb (BPL) lengths the same on both study arms. METHODS Four hundred forty-four patients were randomized to receive either a Very Long Roux Limb LRYGB (VLRL-LRYGB) (variable RL length, BPL 60 cm, and CC 100 cm) or a Standard LRYGB (S-LRYGB) (RL 150 cm, BPL 60 cm, and a variable CC length). Results at 1-year follow-up for weight loss, effect on obesity-related comorbid conditions, complications, re-operation rate, malnutrition rate, and re-admission rate were investigated. RESULTS Weight loss at 1-year showed no significant differences for %EWL (84.3% versus 85.3%, p = 0.72) and %TWL (34.2% versus 33.6%, p = 0.359) comparing VLRL-LRYGB versus S-LRYGB. Malabsorption requiring surgical bowel length adjustment was observed in 1.4% in VLRL-LRYGB group versus 0.9% in S-LRYGB group (p = 0.316). CONCLUSION Significant lengthening of the RL at the cost of the common channel seems to have no effect on the weight loss at 1-year follow-up, which supports the theory that absorption of nutrients also occurs in the RL. Nevertheless, long-term results of the VLRL-LRYGB have to be awaited to draw final conclusions as part of the discussion towards optimal limb length in LRYGB surgery.",2020,"Significant lengthening of the RL at the cost of the common channel seems to have no effect on the weight loss at 1-year follow-up, which supports the theory that absorption of nutrients also occurs in the RL.",['Four hundred forty-four patients'],"['laparoscopic Roux-en-Y Gastric Bypass (LRYGB', 'Very Long Roux Limb LRYGB (VLRL-LRYGB) (variable RL length, BPL 60\xa0cm, and CC 100\xa0cm) or a Standard LRYGB (S-LRYGB', 'significant lengthening of the length of the Roux limb (RL', 'Standard Versus Distal Roux-en-Y Gastric Bypass with Similar Biliopancreatic Bowel Limb Lengths']","['weight loss, effect on obesity-related comorbid conditions, complications, re-operation rate, malnutrition rate, and re-admission rate', 'weight loss', 'Malabsorption requiring surgical bowel length adjustment', 'Weight loss']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C1261315', 'cui_str': 'Limb length'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0441592', 'cui_str': 'Surgical lengthening - action'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1275743', 'cui_str': 'Co-morbid conditions'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0024523', 'cui_str': 'Malabsorption syndrome'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}]",444.0,0.0283902,"Significant lengthening of the RL at the cost of the common channel seems to have no effect on the weight loss at 1-year follow-up, which supports the theory that absorption of nutrients also occurs in the RL.","[{'ForeName': 'Ralph P M', 'Initials': 'RPM', 'LastName': 'Gadiot', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045, PM, Rotterdam, The Netherlands. ralph_gadiot@yahoo.com.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Leeman', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045, PM, Rotterdam, The Netherlands.'}, {'ForeName': 'L Ulas', 'Initials': 'LU', 'LastName': 'Biter', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045, PM, Rotterdam, The Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Dunkelgrun', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045, PM, Rotterdam, The Netherlands.'}, {'ForeName': 'Jan A', 'Initials': 'JA', 'LastName': 'Apers', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045, PM, Rotterdam, The Netherlands.'}, {'ForeName': ""Gerhard Van't"", 'Initials': 'GV', 'LastName': 'Hof', 'Affiliation': 'Department of Bariatric Surgery, Bariatric Center South-West Netherlands, Bravis Hospital, Bergen op Zoom, The Netherlands.'}, {'ForeName': 'Pierre B', 'Initials': 'PB', 'LastName': 'Feskens', 'Affiliation': 'Department of Bariatric Surgery, Bariatric Center South-West Netherlands, Bravis Hospital, Bergen op Zoom, The Netherlands.'}, {'ForeName': 'Guido H', 'Initials': 'GH', 'LastName': 'Mannaerts', 'Affiliation': 'Department of Surgery, Tawam Hospital/ Johns Hopkins, Al Ain, Abu Dhabi, United Arab Emirates.'}]",Obesity surgery,['10.1007/s11695-020-04982-7'] 1399,32956528,"Making use of three-dimensional models of teeth, manufactured by stereolithographic technology, in practical teaching of endodontics.","INTRODUCTION Making use of 3D printed teeth models in teaching students offers an innovative approach. The mistakes made by the students at the access cavity stage were assessed with the aid of 3D models, and their overall, hands-on learning progress was evaluated. MATERIAL AND METHODS Ninety 3D models of teeth were constructed using stereolithographic technology and then randomly divided into 9 groups. One dentistry student was randomly assigned to each group and then performed primary access cavity in 10 identical 3D models. Then the teeth were evaluated in the order of their preparation, relative to the model tooth. RESULTS The material of 14 (15.5%) out of 90 teeth models sustained significant damage during the preparation. As regards the remaining 76 (84.5%) 3D models, the students committed the greatest number of mistakes on the incisors, and fewer on the molars and the least in the premolars. The difference in the number of errors between particular groups of teeth was statistically significant (P = .0001). The number of errors committed in subsequent repetitions amongst all students was significantly different for the incisors (P = .00215) and premolars (P = .00383), whereas insignificant in the case of molars (P = .77116). CONCLUSIONS Thanks to perfect representation of teeth anatomy; making use of 3D models in the teaching of endodontics may well be recommended as holding substantial potential in improving overall quality of training at the pre-clinical stage, with a view to appreciably reducing overall risk of encountering complications during the actual clinical work.",2021,The difference in the number of errors between particular groups of teeth was statistically significant (p=0.0001).,['Ninety 3D models of teeth were constructed using'],['stereolithographic technology'],"['number of errors', 'number of errors committed in subsequent repetitions']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}]",90.0,0.0197643,The difference in the number of errors between particular groups of teeth was statistically significant (p=0.0001).,"[{'ForeName': 'Przemysław', 'Initials': 'P', 'LastName': 'Kustra', 'Affiliation': 'Department of Conservative Dentistry with Endodontics, Faculty of Medicine, Institute of Dentistry, Jagiellonian University Medical College, Kraków, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Dobroś', 'Affiliation': 'Department of Conservative Dentistry with Endodontics, Faculty of Medicine, Institute of Dentistry, Jagiellonian University Medical College, Kraków, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Zarzecka', 'Affiliation': 'Department of Conservative Dentistry with Endodontics, Faculty of Medicine, Institute of Dentistry, Jagiellonian University Medical College, Kraków, Poland.'}]",European journal of dental education : official journal of the Association for Dental Education in Europe,['10.1111/eje.12604'] 1400,32965655,"PSO-LONG: Design of a Novel, 12-Month Clinical Trial of Topical, Proactive Maintenance with Twice-Weekly Cal/BD Foam in Psoriasis.","BACKGROUND Psoriasis vulgaris is commonly treated with topical corticosteroids and vitamin D analogues. Although potent and super-potent topical corticosteroids are very effective at clearing psoriasis, with short-term reactive treatment durations, symptoms usually recur after treatment discontinuation, necessitating long-term disease management strategies. A foam formulation of calcipotriol and betamethasone dipropionate (Cal/BD foam), consisting of calcipotriol 50 μg/g and betamethasone dipropionate 0.5 mg/g, is approved for the daily treatment of psoriasis for up to 4 weeks. Here, we describe a clinical trial protocol for evaluating the long-term safety and efficacy of twice-weekly Cal/BD foam as a proactive topical maintenance therapy for plaque psoriasis for up to 52 weeks. OBJECTIVE The aim of this trial was to evaluate the safety and efficacy of Cal/BD foam when applied twice weekly for up to 52 weeks as proactive maintenance therapy, with the goal of preventing or delaying disease relapse as long as possible while minimizing adverse effects. METHODS Once-daily Cal/BD foam treatment responders from an initial 4-week open-label period were randomized to receive Cal/BD foam or foam vehicle applied to previously cleared plaques twice weekly for up to 52 weeks. In case of relapse, affected subjects in either group received rescue therapy with once-daily Cal/BD foam for 4 weeks on active areas. Thus, the trial (NCT02899962) compared the long-term use of Cal/BD foam in a proactive approach with a conventional, reactive approach. PLANNED OUTCOMES Efficacy endpoints included the time to first relapse, the number of relapse-free days, and the number of relapses during the maintenance phase. Safety assessments included adverse events, incidence of rebound, local safety and tolerability scores, and effects on calcium metabolism and hypothalamic-pituitary-adrenal axis function. TRIAL REGISTRATION ClinicalTrials.gov identifier, NCT02899962.",2020,"Safety assessments included adverse events, incidence of rebound, local safety and tolerability scores, and effects on calcium metabolism and hypothalamic-pituitary-adrenal axis function. ","['plaque psoriasis for up to 52\xa0weeks', 'in Psoriasis']","['Topical, Proactive Maintenance with Twice-Weekly Cal/BD Foam', 'calcipotriol and betamethasone dipropionate (Cal/BD foam), consisting of calcipotriol 50\xa0μg', 'betamethasone dipropionate']","['adverse events, incidence of rebound, local safety and tolerability scores, and effects on calcium metabolism and hypothalamic-pituitary-adrenal axis function', 'safety and efficacy', 'time to first relapse, the number of relapse-free days, and the number of relapses']","[{'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0065767', 'cui_str': 'calcipotriene'}, {'cui': 'C0053523', 'cui_str': 'Betamethasone dipropionate'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.0714231,"Safety assessments included adverse events, incidence of rebound, local safety and tolerability scores, and effects on calcium metabolism and hypothalamic-pituitary-adrenal axis function. ","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Stein Gold', 'Affiliation': 'Department of Dermatology, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Alonso-Llamazares', 'Affiliation': 'Department of Dermatology, VA Medical Center, Miami, FL, USA.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Lacour', 'Affiliation': 'Department of Dermatology, University Hospital of Nice, Nice, France.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Warren', 'Affiliation': 'Dermatology Centre, Salford Royal NHS Foundation Trust, NIHR Manchester BRC University of Manchester, Manchester, UK.'}, {'ForeName': 'Stephen K', 'Initials': 'SK', 'LastName': 'Tyring', 'Affiliation': 'Department of Dermatology, University of Texas Health Science Center, Houston, TX, USA.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Kircik', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Yamauchi', 'Affiliation': 'Division of Dermatology, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lebwohl', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA. lebwohl@aol.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Advances in therapy,['10.1007/s12325-020-01497-6'] 1401,32970162,Results of a randomized controlled phase III trial: efficacy of polyphenol-containing cystus® tea mouthwash solution for the reduction of mucositis in head and neck cancer patients undergoing external beam radiotherapy.,"PURPOSE To determine the effect of Cystus® tea (Naturprodukte Dr. Pandalis GmbH & Co. KG) as mouthwash compared to sage tea on oral mucositis in patients undergoing radio(chemo)therapy for head and neck cancer. METHODS In this randomized, prospective phase III study, 60 head and neck cancer patients with primary or postoperative radio(chemo)therapy were included between 04/2012 and 06/2014. They received either sage or Cystus® tea for daily mouthwash under therapy. Mucositis was scored twice a week following the Radiation Therapy Oncology Group and the European Organization for Research and Treatment Cancer (RTOG/EORTC) scoring system. Dental parameters were also recorded. Statistical evaluation of the primary endpoint was performed using t‑test and log rank test. RESULTS Data from 57 patients could be evaluated. Patient characteristics showed no significant difference between the two groups (n = 27 sage; n = 30 Cystus®). A total of 55 patients received the prescribed dose (60-66 Gy postoperative; 70-76.8 Gy primary). Mucositis grade 3 was observed in 23 patients (n = 11 sage; n = 12 Cystus®) and occurred between day 16 and 50 after start of therapy. There was no significant difference between the two groups in latency (p = 0.75) and frequency (p = 0.85) of the occurrence of mucositis grade 3. The self-assessment of the oral mucosa and the tolerability of the tea also showed no significant differences. Occurrence of dental pathologies appeared to increase over time after radiotherapy. CONCLUSION Cystus® and sage tea have a similar effect on the occurrence of radiation-induced mucositis regarding latency and incidence. Cystus® tea mouthwash solution is tolerated well and can be applied in addition to intensive oral care and hygiene along with the application of fluorides.",2021,Patient characteristics showed no significant difference between the two groups (n = 27 sage; n = 30 Cystus®).,"['60\xa0head and neck cancer patients with primary or postoperative radio(chemo)therapy were included between 04/2012 and 06/2014', 'head and neck cancer patients undergoing external beam radiotherapy', 'patients undergoing radio(chemo)therapy for head and neck cancer']","['sage or Cystus® tea', 'polyphenol-containing cystus® tea mouthwash solution', 'sage tea', 'Cystus® and sage tea', 'Cystus® tea (Naturprodukte Dr. Pandalis GmbH & Co. KG']","['Occurrence of dental pathologies', 'mucositis', 'Mucositis', 'Mucositis grade\xa03']","[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}]","[{'cui': 'C1122976', 'cui_str': 'Sage'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}]",,0.0436231,Patient characteristics showed no significant difference between the two groups (n = 27 sage; n = 30 Cystus®).,"[{'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Ebert', 'Affiliation': 'German Cancer Research Center (DKFZ), Heidelberg, Germany. nadja.ebert@uniklinikum-dresden.de.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kensche', 'Affiliation': 'Clinic of Operative and Pediatric Dentistry, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität, Dresden, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Löck', 'Affiliation': 'Department of Radiotherapy and Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität, Dresden, Germany.'}, {'ForeName': 'Wahyu Wijaya', 'Initials': 'WW', 'LastName': 'Hadiwikarta', 'Affiliation': 'German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hänsch', 'Affiliation': 'Clinic of Operative and Pediatric Dentistry, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität, Dresden, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Dörr', 'Affiliation': ''}, {'ForeName': 'Mechthild', 'Initials': 'M', 'LastName': 'Krause', 'Affiliation': 'German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hannig', 'Affiliation': 'Clinic of Operative and Pediatric Dentistry, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität, Dresden, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Baumann', 'Affiliation': 'German Cancer Research Center (DKFZ), Heidelberg, Germany.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-020-01684-y'] 1402,32973577,A Novel Treatment of Opioid Cravings With an Effect Size of .73 for Unilateral Transcranial Photobiomodulation Over Sham.,"Background Opioid use disorders (OUDs) are an epidemic causing catastrophic consequences to individuals, families, and society despite treatments including psychotherapy, substitution therapy or receptor blockers, and psychoeducation. We have developed a novel treatment that combines unilateral transcranial photobiomodulation (t-PBM) to the hemisphere with a more positive valence by Dual Brain Psychology (DBP). Methods We used a randomized, double blind, placebo-controlled protocol in which 22 patients with significant opioid cravings and a history of recent or current OUD attended three 1-h weekly sessions. After baseline measures of opioid craving and other psychometrics, subjects received two unilateral t-PBM applications (810 nm CW LED, 250 mW/cm 2 , 60 J/cm 2 , 4 min) or a sham (foil-covered LED) at F3 or F4. Prior to any treatment we used two tests to determine which hemisphere was more associated with a negative outlook and cravings and treated that side before the more positive hemisphere. Primary outcome measure was an opioid craving scale (OCS). Secondary outcomes were weekly Hamilton Depression (HDRS) and Anxiety (HARS) Rating Scales prior to treatments and at follow-up. Results Immediately after treatment the OCS improved significantly for both the sham and active treatments, but one week later the active treatment showed a 51.0% (SD 33.7) decrease in OCS while a week after the sham treatments there was a decrease of only 15.8% (SD 35.0) (by Wilcoxon Sign Rank Test, p = 0.004) and by a mixed model it was p = 0.0071. The effect size for the differences between active and sham was 0.73. For the active treatment from before and after treatment the effect size was 1.51 and for the sham, 0.45. The HDRS improved from a baseline of 15.1 to 8.8 (SD 10.3) a week after the active treatment and to 13.3 (SD 12.9) after the sham (p = 0.0071). HARS improved from 14.7 to 8.0 (SD 13.2) after the active treatments and to 14.3 (SD 16.0) after the sham, p = 0.08. Active treatment of the positive hemisphere after the negative hemisphere significantly improved the OCS, but there was no significant difference after the sham treatment. One patient complained of 2 h of abdominal bloating and dropped out; no other adverse effects were observed. Discussion Unilateral t-PBM to the hemisphere with a more positive hemispheric emotional valence was an effective and safe treatment for opioid cravings as well as for depression and anxiety. Our results also lend support to the underlying premises of DBP.",2020,"Immediately after treatment the OCS improved significantly for both the sham and active treatments, but one week later the active treatment showed a 51.0% (SD 33.7) decrease in OCS while a week after the sham treatments there was a decrease of only 15.8% (SD 35.0) (by Wilcoxon Sign Rank Test, p = 0.004) and by a mixed model it was p = 0.0071.",['22 patients with significant opioid cravings and a history of recent or current OUD attended three 1-h weekly sessions'],"['unilateral transcranial photobiomodulation (t-PBM', 'placebo', 'unilateral t-PBM applications']","['abdominal bloating', 'OCS', 'positive hemispheric emotional valence', 'weekly Hamilton Depression (HDRS) and Anxiety (HARS', 'adverse effects', 'opioid craving scale (OCS', 'HDRS', 'HARS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205139', 'cui_str': 'Hemispheric'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",22.0,0.301561,"Immediately after treatment the OCS improved significantly for both the sham and active treatments, but one week later the active treatment showed a 51.0% (SD 33.7) decrease in OCS while a week after the sham treatments there was a decrease of only 15.8% (SD 35.0) (by Wilcoxon Sign Rank Test, p = 0.004) and by a mixed model it was p = 0.0071.","[{'ForeName': 'Fredric', 'Initials': 'F', 'LastName': 'Schiffer', 'Affiliation': 'MindLight, LLC, Newton Highlands, MA, United States.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Reichmann', 'Affiliation': 'Independent Consultant, Danvers, MA, United States.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Flynn', 'Affiliation': 'MindLight, LLC, Newton Highlands, MA, United States.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Hamblin', 'Affiliation': 'Wellman Center for Photomedicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'McCormack', 'Affiliation': 'MindLight, LLC, Newton Highlands, MA, United States.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00827'] 1403,32950444,Impact of Mitral Regurgitation Severity and Left Ventricular Remodeling on Outcome After MitraClip Implantation: Results From the Mitra-FR Trial.,"OBJECTIVES This study aimed to identify a subset of patients based on echocardiographic parameters who might have benefited from transcatheter correction using the MitraClip system in the MITRA-FR (Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation) trial. BACKGROUND It has been suggested that differences in the degree of mitral regurgitation (MR) and left ventricular (LV) remodeling may explain the conflicting results between the MITRA-FR and the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trials. METHODS In a post hoc analysis, we evaluated the interaction between the intervention and subsets of patients defined based on MR severity (effective regurgitant orifice [ERO], regurgitant volume [RVOL] and regurgitant fraction [RF]), LV remodeling (end-diastolic and end-systolic diameters and volumes) and combination of these parameters with respect to the composite of death from any cause or unplanned hospitalization for heart failure at 24 months. RESULTS We observed a neutral impact of the intervention in subsets with the highest MR degree (ERO ≥30 mm 2 , RVOL ≥45 ml or RF ≥50%) as in patients with milder MR degree. The same was seen in subsets with the milder LV remodeling using either diastolic or systolic diameters or volumes. When parameters of MR severity and LV remodeling were combined, there was still no benefit of the intervention including in the subset of patients with an ERO/end-diastolic volume ratio ≥ 0.15 despite similar ERO and LV end-diastolic volume compared with COAPT patients. CONCLUSIONS In the MITRA-FR trial, we could not identify a subset of patients defined based on the degree of the regurgitation, LV remodeling or on their combination, including those deemed as having disproportionate MR, that might have benefited from transcatheter correction using the MitraClip system. (Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation [MITRA-FR]; NCT01920698).",2021,"When parameters of MR severity and LV remodeling were combined, there was still no benefit of the intervention including in the subset of patients with an ERO/end-diastolic volume ratio ≥ 0.15 despite similar ERO and LV end-diastolic volume compared with COAPT patients. ","['subsets with the highest MR degree (ERO\xa0≥30\xa0mm 2 , RVOL\xa0≥45', 'With Severe Secondary Mitral Regurgitation [MITRA-FR', 'Patients', 'Heart\xa0Failure Patients with Functional Mitral Regurgitation) trials', 'patients based on echocardiographic parameters who might have benefited from transcatheter correction using the Mitraclip system in the MITRA-FR (Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation) trial']","['Percutaneous Mitral Valve Repair MitraClip Device', 'Mitraclip Implantation', 'ml or RF', 'MitraClip Percutaneous Therapy']","['MR severity and LV remodeling', 'MR severity (effective regurgitant orifice [ERO], regurgitant volume [RVOL] and regurgitant fraction [RF]), LV remodeling (end-diastolic and end-systolic diameters and volumes) and combination of these parameters with respect to the composite of death from any cause or unplanned hospitalization for heart failure at 24\xa0months']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0340369', 'cui_str': 'Functional mitral regurgitation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0396849', 'cui_str': 'Mitral valvuloplasty'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600520', 'cui_str': 'Left Ventricular Remodeling'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1302309', 'cui_str': 'Regurgitant fraction'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",,0.0446211,"When parameters of MR severity and LV remodeling were combined, there was still no benefit of the intervention including in the subset of patients with an ERO/end-diastolic volume ratio ≥ 0.15 despite similar ERO and LV end-diastolic volume compared with COAPT patients. ","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Messika-Zeitoun', 'Affiliation': 'Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Canada. Electronic address: DMessika-zeitoun@ottawaheart.ca.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Iung', 'Affiliation': 'Université de Paris and INSERM 1148, Paris, France; APHP, Hôpital Bichat, DHU FIRE, Paris, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Armoiry', 'Affiliation': 'Edouard Herriot Hospital, Pharmacy Department/Claude Bernard University-Laboratoire MATEIS, Lyon, France.'}, {'ForeName': 'Jean-Noël', 'Initials': 'JN', 'LastName': 'Trochu', 'Affiliation': ""Université Nantes, CHU Nantes, CNRS, INSERM, l'institut du Thorax, Nantes, France.""}, {'ForeName': 'Erwan', 'Initials': 'E', 'LastName': 'Donal', 'Affiliation': 'CHU de Rennes, Hôpital Pontchaillou, Rennes, France and LTSI UMR1099, INSERM, Universite de Rennes-1, Rennes, France.'}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Habib', 'Affiliation': 'APHM, La Timone Hospital, Cardiology Department, Marseille France; Aix Marseille Univ, IRD, APHM, MEPHI, IHU-Méditerranée Infection, Marseille, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Brochet', 'Affiliation': 'APHP, Hôpital Bichat, DHU FIRE, Paris, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Thibault', 'Affiliation': ""Groupement Hospitalier Est, Hospices Civils de Lyon, Service d'Explorations Fonctionnelles Cardiovasculaires, Bron, France.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Piriou', 'Affiliation': ""Université Nantes, CHU Nantes, CNRS, INSERM, l'institut du Thorax, Nantes, France.""}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Cormier', 'Affiliation': 'Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Tribouilloy', 'Affiliation': 'Department of Cardiology, Amiens University Hospital, EA 7517 MP3CV, Jules Verne University of Picardie, Amiens, France.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Guerin', 'Affiliation': 'CHU Nantes, INSERM UMR 1229, Nantes University, Interventional Cardiology unit, Institut du Thorax, Nantes, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lefèvre', 'Affiliation': 'Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Maucort-Boulch', 'Affiliation': 'Université Lyon 1, Villeurbanne, France; CNRS, UMR5558, Laboratoire de Biométrie et Biologie Évolutive, Équipe Biostatistique-Santé, Service de Biostatistique - Bioinformatique, Pôle Santé Publique, Hospices Civils de Lyon, Villeurbanne, France.'}, {'ForeName': 'Alec', 'Initials': 'A', 'LastName': 'Vahanian', 'Affiliation': 'Université de Paris and INSERM 1148, Paris, France.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Boutitie', 'Affiliation': 'Université Lyon 1, Villeurbanne, France; CNRS, UMR5558, Laboratoire de Biométrie et Biologie Évolutive, Équipe Biostatistique-Santé, Service de Biostatistique - Bioinformatique, Pôle Santé Publique, Hospices Civils de Lyon, Villeurbanne, France.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Obadia', 'Affiliation': 'Hopital Cardiovasculaire Louis Pradel, Chirurgie Cardio-Vasculaire et Transplantation Cardiaque, Hospices Civils de Lyon and Claude Bernard University, Lyon, France. Electronic address: jean-francois.obadia@chu-lyon.fr.'}]",JACC. Cardiovascular imaging,['10.1016/j.jcmg.2020.07.021'] 1404,32950546,Twice-weekly topical calcipotriene/betamethasone dipropionate foam as proactive management of plaque psoriasis increases time in remission and is well tolerated over 52 weeks (PSO-LONG trial).,"BACKGROUND Topical psoriasis treatment relies on a reactive rather than a long-term proactive approach to disease relapse. OBJECTIVE Assess long-term efficacy and safety of proactive psoriasis management with twice-weekly calcipotriene 0.005%/betamethasone dipropionate 0.064% (Cal/BD) foam. METHODS Phase III trial (NCT02899962) included a 4-week open-label lead-in phase (Cal/BD foam once daily) and a 52-week, randomized, double-blind, maintenance phase. A total of 545 patients achieved treatment success (physician's global assessment ""clear""/""almost clear,"" ≥2-grade improvement from baseline) and were randomized to proactive management (Cal/BD foam; n = 272) or reactive management (vehicle foam; n = 273) twice-weekly, with rescue treatment of Cal/BD foam once daily for 4 weeks upon relapse. Primary endpoint was time to first relapse (physician's global assessment ""mild"" or higher). RESULTS A total of 251 randomized patients (46.1%) completed the trial. Median time to first relapse was 56 days (proactive) and 30 days (reactive). Patients in the proactive group had an additional 41 days in remission compared with the reactive group over 1 year (P < .001). Number of relapses per year of exposure was 3.1 (proactive) and 4.8 (reactive). Cal/BD foam was well tolerated. LIMITATIONS Maintenance phase dropout rate (53.9%) was within the expected range but provides challenges in statistical analysis. CONCLUSION Long-term proactive management with Cal/BD foam demonstrated superior efficacy vs reactive management.",2021,Patients in the proactive group had an additional 41 days in remission compared with the reactive group over 1 year (P < 0.001).,['545 patients'],"['calcipotriene / betamethasone dipropionate', 'proactive psoriasis management with twice-weekly calcipotriene', '0.005%/betamethasone dipropionate', '4-week open-label lead-in phase (Cal/BD foam once-daily']","[""time to first relapse (PGA ≥'mild"", 'tolerated', 'Median time']","[{'cui': 'C4517809', 'cui_str': '545'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0065767', 'cui_str': 'calcipotriene'}, {'cui': 'C0053523', 'cui_str': 'Betamethasone dipropionate'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C4517414', 'cui_str': '0.064'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.227363,Patients in the proactive group had an additional 41 days in remission compared with the reactive group over 1 year (P < 0.001).,"[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lebwohl', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: lebwohl@aol.com.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Kircik', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Lacour', 'Affiliation': 'Department of Dermatology, University Hospital of Nice, Nice, France.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Liljedahl', 'Affiliation': 'LEO Pharma Ballerup, Ballerup, Denmark.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Lynde', 'Affiliation': 'Lynde Dermatology, Probity Medical Research, Markham, Ontario, Canada; Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Marie Holst', 'Initials': 'MH', 'LastName': 'Mørch', 'Affiliation': 'LEO Pharma Ballerup, Ballerup, Denmark.'}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Papp', 'Affiliation': 'K. Papp Clinical Research, Waterloo, Ontario, Canada.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Perrot', 'Affiliation': 'Department of Dermatology, University Hospital of St-Etienne, St-Etienne, France.'}, {'ForeName': 'Linda Stein', 'Initials': 'LS', 'LastName': 'Gold', 'Affiliation': 'Department of Dermatology, Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'Amrit', 'Initials': 'A', 'LastName': 'Takhar', 'Affiliation': 'Wansford and Kings Cliffe Practice, Wansford, Cambridgeshire, United Kingdom.'}, {'ForeName': 'Diamant', 'Initials': 'D', 'LastName': 'Thaçi', 'Affiliation': 'Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Warren', 'Affiliation': 'Dermatology Centre, Salford Royal National Health Service Foundation Trust, Manchester National Institute for Health Research Biomedical Research Centre, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wollenberg', 'Affiliation': 'Department of Dermatology and Allergology, Ludwig Maximilian University Munich, Munich, Germany.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.09.037'] 1405,33236105,"Reduction in acute kidney injury post cardiac surgery using balanced forced diuresis: a randomized, controlled trial.","OBJECTIVES Our goal was to investigate the efficacy of balanced forced diuresis in reducing the rate of acute kidney injury (AKI) in cardiac surgical patients requiring cardiopulmonary bypass (CPB), using the RenalGuard® (RG) system. METHODS Patients at risk of developing AKI (history of diabetes and/or anaemia; estimated glomerular filtration rate 20-60 ml/min/1.73 m2; anticipated CPB time >120 min; log EuroSCORE > 5) were randomized to the RG system group (n = 110) or managed according to current practice (control = 110). The primary end point was the development of AKI within the first 3 postoperative days as defined by the RIFLE (Risk, Injury, Failure, Loss of kidney function, End-stage renal disease) criteria. RESULTS There were no significant differences in preoperative and intraoperative characteristics between the 2 groups. Postoperative AKI rates were significantly lower in the RG system group compared to the control group [10% (11/110) vs 20.9% (23/110); P = 0.025]. This effect persisted even after controlling for a number of potential confounders (odds ratio 2.82, 95% confidence interval 1.20-6.60; P = 0.017) when assessed by binary logistic regression analysis. The mean volumes of urine produced during surgery and within the first 24 h postoperatively were significantly higher in the RG system group (P < 0.001). There were no significant differences in the incidence of blood transfusions, atrial fibrillation and infections and in the median duration of intensive care unit stays between the groups. The number needed to treat with the RG system to prevent AKI was 9 patients (95% confidence interval 6.0-19.2). CONCLUSIONS In patients at risk for AKI who had cardiac surgery with CPB, the RS RG system significantly reduced the incidence of AKI and can be used safely and reproducibly. Larger studies are required to confirm cost benefits. CLINICAL TRIAL REGISTRATION NUMBER NCT02974946.",2021,The mean volumes of urine produced during surgery and within the first 24 h postoperatively were significantly higher in the RG system group (P < 0.001).,"['acute kidney injury post cardiac surgery using balanced forced diuresis', 'cardiac surgical patients requiring cardiopulmonary bypass (CPB), using the RenalGuard® (RG) system', 'Patients at risk of developing AKI (history of diabetes and/or anaemia; estimated glomerular filtration rate 20-60\u2009ml']",['balanced forced diuresis'],"['Postoperative AKI rates', 'incidence of blood transfusions, atrial fibrillation and infections and in the median duration of intensive care unit stays', 'development of AKI within the first 3 postoperative days as defined by the RIFLE (Risk, Injury, Failure, Loss of kidney function, End-stage renal disease) criteria', 'mean volumes of urine', 'preoperative and intraoperative characteristics']","[{'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0554808', 'cui_str': 'Forced diuresis'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0554808', 'cui_str': 'Forced diuresis'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0035611', 'cui_str': 'Rifle'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1278293', 'cui_str': 'Urine sample volume measurement'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]",5.0,0.262125,The mean volumes of urine produced during surgery and within the first 24 h postoperatively were significantly higher in the RG system group (P < 0.001).,"[{'ForeName': 'Heyman', 'Initials': 'H', 'LastName': 'Luckraz', 'Affiliation': 'Cardiothoracic Surgeon, American Hospital, Dubai, United Arab Emirates.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Giri', 'Affiliation': 'Cardiothoracic Anaesthesiologist, Heart and Lung Centre, Wolverhampton, UK.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Wrigley', 'Affiliation': 'Interventional Cardiologist, Heart and Lung Centre, Wolverhampton, UK.'}, {'ForeName': 'Kumaresan', 'Initials': 'K', 'LastName': 'Nagarajan', 'Affiliation': 'Specialist Registrar Cardiothoracic Surgery, Heart and Lung Centre, Wolverhampton, UK.'}, {'ForeName': 'Eshan', 'Initials': 'E', 'LastName': 'Senanayake', 'Affiliation': 'Specialist Registrar Cardiothoracic Surgery, Heart and Lung Centre, Wolverhampton, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Sharman', 'Affiliation': 'Research and Development Department, Heart and Lung Centre, Wolverhampton, UK.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Beare', 'Affiliation': 'Senior Clinical Perfusionist, Heart and Lung Centre, Wolverhampton, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Nevill', 'Affiliation': 'Statistics, Faculty of Education, Health and Wellbeing, University of Wolverhampton, Wolverhampton, UK.'}]",European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery,['10.1093/ejcts/ezaa395'] 1406,32956960,Mental health promotion and prevention interventions in families with parental depression: A randomized controlled trial.,"BACKGROUND The transgenerational transmission of affective disorders calls for integrating promotion of child development in the services offered to families with parental depression. The main objective of the present research was to examine the effectiveness and differences in the impact of two relevant interventions in Greece. METHODS Thirty families of depressed patients were randomly assigned to the six-to-eight session Family Talk Intervention group and 32 families were included in the lower intensity parent-only two-to-three session Let's Talk about the Children group. Depressed parents and the eldest of their children were assessed prior to the interventions and 4, 10, and 18 months following baseline assessment. RESULTS In both groups there were significant improvements in parent's depression, anxiety, perceived social support, parenting and family functioning, as well as improvements in child's depression, anxiety, and child emotional/behavioral problems. Child's prosocial behavior, perceived social support, and health-related quality of life were significantly improved in both groups. All positive effects were evident four months following baseline assessment and could be still documented at 1.5-year follow-up. Mixed linear models showed that family functioning and parenting to a lesser extent were associated with the greatest changes in children's psychosocial outcomes in both interventions.. LIMITATIONS The lack of data regarding parents that refused to receive the interventions may limit generalizability of results. A further limitation is the lack of a no-intervention control group. CONCLUSIONS The study offers a preliminary evidence base for integrating preventive interventions for child mental health in routine clinical practice with adult depressed patients.",2021,"In both groups there were significant improvements in parent's depression, anxiety, perceived social support, parenting and family functioning, as well as improvements in child's depression, anxiety, and child emotional/behavioral problems.","['families with parental depression', 'Thirty families of depressed patients', 'child mental health in routine clinical practice with adult depressed patients']","['Mental health promotion and prevention interventions', 'six-to-eight session Family Talk Intervention group and 32 families were included in the lower intensity parent-only two-to-three session']","[""parent's depression, anxiety, perceived social support, parenting and family functioning, as well as improvements in child's depression, anxiety, and child emotional/behavioral problems"", ""Child's prosocial behavior, perceived social support, and health-related quality of life""]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0184645', 'cui_str': 'Mental health promotion'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0680051', 'cui_str': 'Family functioning capacity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",32.0,0.0624,"In both groups there were significant improvements in parent's depression, anxiety, perceived social support, parenting and family functioning, as well as improvements in child's depression, anxiety, and child emotional/behavioral problems.","[{'ForeName': 'George', 'Initials': 'G', 'LastName': 'Giannakopoulos', 'Affiliation': 'Department of Child Psychiatry, School of Medicine, National and Kapodistrian University of Athens, ""Aghia Sophia"" Children\'s Hospital, Athens, Greece. Electronic address: ggiannak@med.uoa.gr.'}, {'ForeName': 'Tytti', 'Initials': 'T', 'LastName': 'Solantaus', 'Affiliation': 'MIELI Mental Health Finland, Helsinki, Finland; Finnish Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Chara', 'Initials': 'C', 'LastName': 'Tzavara', 'Affiliation': 'Department of Child Psychiatry, School of Medicine, National and Kapodistrian University of Athens, ""Aghia Sophia"" Children\'s Hospital, Athens, Greece.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Kolaitis', 'Affiliation': 'Department of Child Psychiatry, School of Medicine, National and Kapodistrian University of Athens, ""Aghia Sophia"" Children\'s Hospital, Athens, Greece.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.070'] 1407,32958697,Association of elevated hs-CRP and multiple infarctions with outcomes of minor stroke or TIA: subgroup analysis of CHANCE randomised clinical trial.,"BACKGROUND AND PURPOSE The relationship of high-sensitive C-reactive protein (hs-CRP) levels and infarction numbers with the prognosis of stroke is uncertain. This study evaluated the association of different hs-CRP levels and infarction numbers with the prognosis of acute minor ischaemic stroke or transient ischaemic attack (TIA). METHODS A subset of 807 patients with both hs-CRP measurement and baseline MRI was included from the Clopidogrel in High-risk Patients with Acute Non-disabling Cerebrovascular Events trial. The primary efficacy outcome was the occurrence of an ischaemic stroke at the 1-year follow-up. Infarction numbers were classified as multiple acute infarctions (MAIs), single acute infarction and no acute infarction (NAI). The association between different hs-CRP levels with different infarction numbers and the risk of any outcome was analysed using multivariable Cox regression models. RESULTS Among the 807 patients, 84 (10.4%) patients had a recurrent ischaemic stroke within 1 year. After adjustment for conventional confounding factors, patients with both elevated hs-CRP levels and MAIs were associated with approximately 4.7-fold of risk of ischaemic stroke within 1 year (16.7% vs 3.5%, HR 4.68, 95% CI 1.54 to 14.23, p=0.007), compared with those with non-elevated hs-CRP levels and NAI. Similar results were observed for the composite events. CONCLUSIONS Combined elevated hs-CRP levels and MAIs may increase 1-year stroke risk stratification efficiency in patients with minor ischaemic stroke or TIA compared with using those markers alone, which indicated that the combination of inflammatory and imaging markers might improve the effectiveness of risk stratification concerning minor ischaemic stroke or TIA.ClinicalTrials.gov Registry (NCT00979589).",2021,"Combined elevated hs-CRP levels and MAIs may increase 1-year stroke risk stratification efficiency in patients with minor ischaemic stroke or TIA compared with using those markers alone, which indicated that the combination of inflammatory and imaging markers might improve the effectiveness of risk stratification concerning minor ischaemic stroke or TIA.ClinicalTrials.gov Registry (NCT00979589).","['patients with minor ischaemic stroke or TIA', '807 patients with both hs-CRP measurement and baseline MRI was included from the']",['Clopidogrel'],"['recurrent ischaemic stroke', 'multiple acute infarctions (MAIs), single acute infarction and no acute infarction (NAI', 'ischaemic stroke', '1-year stroke risk stratification efficiency', 'occurrence of an ischaemic stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1277291', 'cui_str': 'Stroke risk'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",807.0,0.331491,"Combined elevated hs-CRP levels and MAIs may increase 1-year stroke risk stratification efficiency in patients with minor ischaemic stroke or TIA compared with using those markers alone, which indicated that the combination of inflammatory and imaging markers might improve the effectiveness of risk stratification concerning minor ischaemic stroke or TIA.ClinicalTrials.gov Registry (NCT00979589).","[{'ForeName': 'Guangyao', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jing', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jiejie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yuesong', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hongyi', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xingquan', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'David Z', 'Initials': 'DZ', 'LastName': 'Wang', 'Affiliation': ""Neurovascular Division, Department of Neurology, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, Arizona, USA.""}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China yilong528@gmail.com yongjunwang@ncrcnd.org.cn.'}, {'ForeName': 'Yilong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China yilong528@gmail.com yongjunwang@ncrcnd.org.cn.'}]",Stroke and vascular neurology,['10.1136/svn-2020-000369'] 1408,32970315,"Bioequivalence Study Comparing Fixed-Dose Combination of Clopidogrel and Aspirin with Coadministration of Individual Formulations in Chinese Subjects Under Fed Conditions: A Phase I, Open-Label, Randomized, Crossover Study.","INTRODUCTION Simultaneous administration of acetylsalicylic acid (ASA) and clopidogrel has demonstrated efficacy in the treatment of acute coronary syndrome. Clopidogrel + ASA in a fixed-dose combination (FDC) provides a pharmaceutical option to enhance adherence to the coadministration of dual antiplatelet therapy (DAPT). Herein, we evaluate the bioequivalence of enteric ASA and clopidogrel in an FDC compared with simultaneous administration of the individual formulations. METHODS This study is a randomized, single-center, open-label, three-sequence, three-period, two-treatment, crossover study conducted in healthy Chinese male and female subjects under fed conditions. Subjects were randomized to receive, in each period, a single dose of (1) a combination tablet containing 75-mg clopidogrel and 100-mg enteric ASA (test formulation) or (2) coadministration of one 75-mg clopidogrel tablet and one 100-mg enteric-coated ASA tablet (reference formulations) under fed conditions. Plasma samples were analyzed for ASA, salicylic acid, clopidogrel, and the clopidogrel metabolite SR26334. For ASA, the reference-scaled average bioequivalence (RSABE) analysis was conducted for C max of ASA because within-subject standard deviation (SD W ) was ≥ 0.294 for log-transformed C max . RESULTS The point estimate (test/reference geometric mean ratio) was between 0.80 and 1.25, and the upper one-sided 95% confidence interval (CI) for the scaled average bioequivalence metric was ≤ 0 (-0.08). AUC of ASA as SD W was < 0.294 for log-transformed AUC last and AUC. Estimates of 90% CIs for log-transformed AUC last and AUC ratios were within the bioequivalence range of 0.80 to 1.25 (0.98-1.08 and 1.00-1.10, respectively). For clopidogrel, the 90% CIs for the ratios comparing log-transformed C max , AUC last , and AUC ratios of clopidogrel following administration of test versus reference formulation were calculated using the ABE method and were well within the acceptable range of 0.80 to 1.25 (1.02-1.12, 0.92-0.99, and 0.92-0.98, respectively). CONCLUSION FDC of ASA and clopidogrel was bioequivalent to the simultaneous administration of the individual formulations in healthy Chinese subjects under fed conditions. TRIAL REGISTRATION CTR20190376.",2020,AUC of ASA as SD W was < 0.294 for log-transformed AUC,"['healthy Chinese subjects under fed conditions', 'acute coronary syndrome', 'healthy Chinese male and female subjects under fed conditions', 'Chinese Subjects Under Fed Conditions']","['Clopidogrel and Aspirin with Coadministration of Individual Formulations', 'combination tablet containing 75-mg clopidogrel and 100-mg enteric ASA (test formulation) or (2) coadministration of one 75-mg clopidogrel tablet and one 100-mg enteric-coated ASA tablet (reference formulations) under fed conditions', 'clopidogrel', 'Clopidogrel\u2009+\u2009ASA', 'AUC', 'acetylsalicylic acid (ASA) and clopidogrel']","['AUC ratios', 'ratios comparing log-transformed C max , AUC last , and AUC ratios of clopidogrel']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1248670', 'cui_str': 'clopidogrel Oral Tablet'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]",,0.234126,AUC of ASA as SD W was < 0.294 for log-transformed AUC,"[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China.'}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Ming', 'Affiliation': 'Research and Development, Sanofi, New York, USA.'}, {'ForeName': 'Fangyuan', 'Initials': 'F', 'LastName': 'Kong', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Huiqiu', 'Initials': 'H', 'LastName': 'Yin', 'Affiliation': 'Medical, Sanofi, Shanghai, China.'}, {'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Medical, Sanofi, Beijing, China.'}, {'ForeName': 'Haihong', 'Initials': 'H', 'LastName': 'Bai', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Medical, Sanofi, Shanghai, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Ping', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China.'}, {'ForeName': 'Chunyu', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China.'}, {'ForeName': 'Ju', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China.'}, {'ForeName': 'Xinghe', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China. wangxh@bjsjth.cn.'}]",Advances in therapy,['10.1007/s12325-020-01486-9'] 1409,32968544,"An app-, web- and social support-based weight loss intervention for adults with obesity: the 'HelpMeDoIt!' feasibility randomised controlled trial.","Background Social support has an important role in successful weight loss. The aim of this study was to assess the feasibility and acceptability of an app-, web- and social support-based intervention in supporting adults with obesity to achieve weight loss. Methods The intervention and evaluation methods were tested in a feasibility randomised controlled trial. Adults in the Greater Glasgow and Clyde Health Board area of Scotland with a body mass index ≥ 30 kg/m 2 were recruited and randomised 2:1 (intervention to control). The feasibility and acceptability of the intervention and trial methods were assessed against pre-specified progression criteria, via process, economic and outcome evaluation. Three primary outcomes were explored: BMI, diet and physical activity, as well as a number of secondary outcomes. The intervention group had access to the HelpMeDoIt! intervention for 12 months. This encouraged them to (i) set goals, (ii) monitor progress and (iii) harness social support by inviting 'helpers' from their existing social network. The control group received a healthy lifestyle leaflet. Results One hundred and nine participants were recruited, with 84 participants (77%) followed-up at 12 months. The intervention and trial methods were feasible and acceptable. Participants and helpers were generally positive. Of the 54 (74%) participants who downloaded the app, 48 (89%) used it. Interview data indicated that HelpMeDoIt! promoted social support from existing social networks to support weight loss. This support was often given outside of the app.Outcomes were compared using linear regression models, with randomised group, the baseline measurement of the outcome, age and gender as predictor variables. These analyses were exploratory and underpowered to detect effects. However, all pre-specified primary outcome effects (BMI, diet and physical activity) had wide confidence intervals and were therefore consistent with clinically relevant benefits. Objective physical activity measures perhaps showed most potential (daily step count ( p = 0.098; 1187 steps [- 180, 2555])) and sedentary time ( p = 0.022; - 60.8 min [- 110.5, - 11.0]). However, these outcomes were poorly completed. Conclusions The study demonstrated that a novel social support intervention involving support from participants' close social networks, delivered via app and website, has potential to promote weight loss and is feasible and acceptable. Trial registration ISRCTN, ISRCTN85615983. Registered 25 September 2014.",2020,"Objective physical activity measures perhaps showed most potential (daily step count ( p = 0.098; 1187 steps [- 180, 2555])) and sedentary time ( p = 0.022; - 60.8 min [- 110.5, - 11.0]).","['adults with obesity', 'One hundred and nine participants were recruited, with 84 participants (77%) followed-up at 12\u2009months', 'Adults in the Greater Glasgow and Clyde Health Board area of Scotland with a body mass index ≥\u200930\u2009kg/m 2', 'adults with obesity to achieve weight loss']","['novel social support intervention', 'HelpMeDoIt', 'app-, web- and social support-based weight loss intervention', 'app-, web- and social support-based intervention', 'healthy lifestyle leaflet']","['sedentary time', 'Objective physical activity measures', 'feasibility and acceptability', 'BMI, diet and physical activity, as well as a number of secondary outcomes', 'effects (BMI, diet and physical activity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",109.0,0.1362,"Objective physical activity measures perhaps showed most potential (daily step count ( p = 0.098; 1187 steps [- 180, 2555])) and sedentary time ( p = 0.022; - 60.8 min [- 110.5, - 11.0]).","[{'ForeName': 'Sharon Anne', 'Initials': 'SA', 'LastName': 'Simpson', 'Affiliation': 'MRC/CSO Social and Public Health Sciences Unit, Institute of Health and Wellbeing, University of Glasgow, Berkeley Square, 99 Berkeley Street, Glasgow, G3 7HR UK.'}, {'ForeName': 'Lynsay', 'Initials': 'L', 'LastName': 'Matthews', 'Affiliation': 'MRC/CSO Social and Public Health Sciences Unit, Institute of Health and Wellbeing, University of Glasgow, Berkeley Square, 99 Berkeley Street, Glasgow, G3 7HR UK.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Pugmire', 'Affiliation': 'MRC/CSO Social and Public Health Sciences Unit, Institute of Health and Wellbeing, University of Glasgow, Berkeley Square, 99 Berkeley Street, Glasgow, G3 7HR UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'McConnachie', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Robertson Centre, Boyd Orr Building, Glasgow, G12 8QQ UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'McIntosh', 'Affiliation': 'Health Economics and Health Technology Assessment Unit (HEHTA), Institute of Health and Wellbeing, University of Glasgow, 1 Lilybank Gardens, Glasgow, G12 8RZ UK.'}, {'ForeName': 'Elinor', 'Initials': 'E', 'LastName': 'Coulman', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park Way, Cardiff, CF14 4YS UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Hughes', 'Affiliation': 'Division of Population Medicine, School of Medicine, Cardiff University, Neuadd Meirionnydd, Heath Park Way, Cardiff, CF14 4YS UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kelson', 'Affiliation': 'College of Engineering, Mathematics and Physical Sciences, School of Mathematics/The Alan Turing Institute, University of Exeter, Harrison Building, Streatham Campus, North Park Road, Exeter, EX4 4QF UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Morgan-Trimmer', 'Affiliation': ""Institute of Health Research, College of Medicine and Health, University of Exeter, College House, St Luke's Campus, Heavitree Road, Exeter, EX1 2LU UK.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Murphy', 'Affiliation': 'Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), Cardiff School of Social Sciences, Cardiff University, Cardiff, CF10 3AT UK.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Utkina-Macaskill', 'Affiliation': 'MRC/CSO Social and Public Health Sciences Unit, Institute of Health and Wellbeing, University of Glasgow, Berkeley Square, 99 Berkeley Street, Glasgow, G3 7HR UK.'}, {'ForeName': 'Laurence Anthony Russell', 'Initials': 'LAR', 'LastName': 'Moore', 'Affiliation': 'MRC/CSO Social and Public Health Sciences Unit, Institute of Health and Wellbeing, University of Glasgow, Berkeley Square, 99 Berkeley Street, Glasgow, G3 7HR UK.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00656-4'] 1410,30955043,Improvement of Working Memory is a Mechanism for Reductions in Delay Discounting Among Mid-Age Individuals in an Urban Medically Underserved Area.,"BACKGROUND Delay discounting, or the tendency to devalue rewards as a function of their delayed receipt, is associated with myriad negative health behaviors. Individuals from medically underserved areas are disproportionately at risk for chronic health problems. The higher rates of delay discounting and consequent adverse outcomes evidenced among low-resource and unstable environments suggest this may be an important pathway to explain health disparities among this population. PURPOSE The current study examined the effectiveness of a computerized working memory training program to decrease rates of delay discounting among residents of a traditionally underserved region. METHODS Participants (N = 123) were recruited from a community center serving low income and homeless individuals. Subjects completed measures of delay discounting and working memory and then took part in either an active or control working memory training. RESULTS Analyses indicated that participants in the active condition demonstrated significant improvement in working memory and that this improvement mediated the relation between treatment condition and reductions in delay discounting. CONCLUSIONS Results suggest that a computerized intervention targeting working memory may be effective in decreasing rates of delay discounting in adults from medically underserved areas (ClinicalTrials.gov number NCT03501706).",2019,"Subjects completed measures of delay discounting and working memory and then took part in either an active or control working memory training. ","['Participants (N = 123) were recruited from a community center serving low income and homeless individuals', 'residents of a traditionally underserved region', 'Mid-Age Individuals in an Urban Medically Underserved Area']","['computerized working memory training program', 'active or control working memory training']","['delay discounting and working memory', 'rates of delay discounting', 'working memory', 'delay discounting']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0425242', 'cui_str': 'Homeless single person'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0025112', 'cui_str': 'Area, Medically Underserved'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",123.0,0.0429412,"Subjects completed measures of delay discounting and working memory and then took part in either an active or control working memory training. ","[{'ForeName': 'Julia W', 'Initials': 'JW', 'LastName': 'Felton', 'Affiliation': 'Division of Public Health, Michigan State University, Flint, MI, USA.'}, {'ForeName': 'Anahi', 'Initials': 'A', 'LastName': 'Collado', 'Affiliation': 'Cofrin Logan Center for Addiction Research and Treatment, University of Kansas, Lawrence, KS, USA.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Ingram', 'Affiliation': 'Department of Psychology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Doran', 'Affiliation': 'School of Nursing, University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Yi', 'Affiliation': 'Cofrin Logan Center for Addiction Research and Treatment, University of Kansas, Lawrence, KS, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaz010'] 1411,32977975,Multimodal analgesia after thyroid or parathyroid surgery: A randomized controlled trial.,"BACKGROUND The opioid epidemic prompted reevaluation of surgeons' opioid prescribing practices. This study aimed to demonstrate noninferiority of a staged analgesic regimen after endocrine surgery. METHODS We conducted a randomized controlled trial comparing analgesic regimens after thyroidectomy and/or parathyroidectomy. Adult patients (≥18 years) were randomized to study arm (A) as-needed acetaminophen + codeine or (B) scheduled acetaminophen/as-needed tramadol. Patients recorded pain scores and analgesics consumed in a study log. Clinical variables were collected from the medical record. RESULTS Target enrollment was achieved (n = 126), and randomization was even (A: 44.5%, B: 55.6%). There was no difference between enrolled patients and those who returned the study log (52.4%) by sex (P = .667), age (P = .513), final pathology (P = .137), procedure (P = .667), or randomization arm (P = .795). Most patients (50.8%) reported moderate pain scores (4-6) with no difference between study arms (P = .451). There was no difference in average consumption by morphine milligram equivalents (A: 11.5 ± 12.1 vs B: 12.49 ± 18.07; P = .792) nor total analgesic doses (A: 7.29 ± 7.48 vs B: 8.5 ± 5.36; P = .445). However, a significant difference in average percentage of opioid doses was noted (A: 79.71 ± 33.31 vs B: 27.38 ± 31.88; P < .001). CONCLUSION Patients reported moderate pain scores with low requirements for analgesics after endocrine surgery. The staged analgesic regimen is noninferior to combination opioids and led to reduced overall consumption.",2021,Most patients (50.8%) reported moderate pain scores (4-6) with no difference between study arms (P = .451).,['Adult patients (≥18 years'],"['acetaminophen\xa0+ codeine or (B) scheduled acetaminophen/as-needed tramadol', 'thyroidectomy and/or parathyroidectomy', 'Multimodal analgesia after thyroid or parathyroid surgery']","['average consumption by morphine milligram equivalents', 'average percentage of opioid doses', 'moderate pain scores', 'pain scores and analgesics', 'total analgesic doses']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C2351132', 'cui_str': 'codeine and paracetamol'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0079989', 'cui_str': 'Parathyroidectomy'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0030518', 'cui_str': 'Parathyroid structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0278139', 'cui_str': 'Moderate pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.466354,Most patients (50.8%) reported moderate pain scores (4-6) with no difference between study arms (P = .451).,"[{'ForeName': 'Minerva A', 'Initials': 'MA', 'LastName': 'Romero Arenas', 'Affiliation': 'Department of Surgery, School of Medicine, University of Texas Rio Grande Valley, Edinburg, TX. Electronic address: minerva.romeroarenas@utrgv.edu.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Uhlmann', 'Affiliation': 'Department of Surgery, School of Medicine, University of Texas Rio Grande Valley, Edinburg, TX.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Postevka', 'Affiliation': 'School of Medicine, University of Texas Rio Grande Valley, Edinburg, TX.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'School of Mathematical and Statistical Sciences, University of Texas Rio Grande Valley, Edinburg, TX.'}, {'ForeName': 'Henry A', 'Initials': 'HA', 'LastName': 'Reinhart', 'Affiliation': 'Department of Surgery, School of Medicine, University of Texas Rio Grande Valley, Edinburg, TX.'}, {'ForeName': 'Samuel K', 'Initials': 'SK', 'LastName': 'Snyder', 'Affiliation': 'Department of Surgery, School of Medicine, University of Texas Rio Grande Valley, Edinburg, TX.'}]",Surgery,['10.1016/j.surg.2020.08.008'] 1412,32985652,"NEWTON-2 Cisternal (Nimodipine Microparticles to Enhance Recovery While Reducing Toxicity After Subarachnoid Hemorrhage): A Phase 2, Multicenter, Randomized, Open-Label Safety Study of Intracisternal EG-1962 in Aneurysmal Subarachnoid Hemorrhage.","BACKGROUND A sustained release microparticle formulation of nimodipine (EG-1962) was developed for treatment of patients with aneurysmal subarachnoid hemorrhage (aSAH). OBJECTIVE To assess safety, tolerability, and pharmacokinetics of intracisternal EG-1962 in an open-label, randomized, phase 2 study of up to 12 subjects. METHODS Subjects were World Federation of Neurological Surgeons grades 1 to 2, modified Fisher grades 2 to 4, and underwent aneurysm clipping within 48 h of aSAH. EG-1962, containing 600 mg nimodipine, was administered into the basal cisterns. Outcome on the extended Glasgow Outcome Scale (eGOS), pharmacokinetics, delayed cerebral ischemia and infarction, rescue therapy, and safety were evaluated. RESULTS The study was halted when a phase 3 study of intraventricular EG-1962 stopped because that study was unlikely to meet its primary endpoint. Six subjects were randomized (5 EG-1962 and 1 oral nimodipine). After 90-d follow-up, favorable outcome on the eGOS occurred in 1 of 5 EG-1962 and in the single oral nimodipine patient. Four EG-1962 and the oral nimodipine subject had angiographic vasospasm. One EG-1962 subject had delayed cerebral ischemia, and all subjects with angiographic vasospasm received rescue therapy except 1 EG-1962 patient. One subject treated with EG-1962 developed right internal carotid and middle cerebral artery narrowing 5 mo after placement of EG-1962, leading to occlusion and cerebral infarction. Pharmacokinetics showed similar plasma concentrations of nimodipine in both groups. CONCLUSION Angiographic vasospasm and unfavorable clinical outcome still occurred after placement of EG-1962. Internal carotid artery narrowing and occlusion after placement of EG-1962 in the basal cisterns has not been reported.",2020,"One subject treated with EG-1962 developed right internal carotid and middle cerebral artery narrowing 5 mo after placement of EG-1962, leading to occlusion and cerebral infarction.","['Subjects were World Federation of Neurological Surgeons grades 1 to 2, modified Fisher grades 2 to 4, and underwent aneurysm clipping within 48 h of aSAH', 'up to 12 subjects', 'patients with aneurysmal subarachnoid hemorrhage (aSAH', 'Aneurysmal Subarachnoid Hemorrhage', 'After Subarachnoid Hemorrhage', 'Six subjects']","['EG-1962, containing 600\xa0mg nimodipine', 'Cisternal (Nimodipine Microparticles', 'nimodipine (EG-1962', 'Intracisternal EG-1962', 'EG-1962', 'nimodipine', 'intracisternal EG-1962']","['delayed cerebral ischemia', 'angiographic vasospasm', 'eGOS', 'Toxicity', 'plasma concentrations', 'safety, tolerability, and pharmacokinetics', 'Angiographic vasospasm', 'extended Glasgow Outcome Scale (eGOS), pharmacokinetics, delayed cerebral ischemia and infarction, rescue therapy, and safety']","[{'cui': 'C0237427', 'cui_str': 'Neurosurgeon'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0325045', 'cui_str': 'Martes pennanti'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0751530', 'cui_str': 'Subarachnoid Hemorrhage, Aneurysmal'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038525', 'cui_str': 'Subarachnoid hemorrhage'}]","[{'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0028094', 'cui_str': 'Nimodipine'}, {'cui': 'C2350307', 'cui_str': 'Microparticles, Cell-Derived'}, {'cui': 'C1512924', 'cui_str': 'Intracisternal route'}]","[{'cui': 'C4761225', 'cui_str': 'Delayed cerebral ischaemia'}, {'cui': 'C0042396', 'cui_str': 'Vascular constriction'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0701887', 'cui_str': 'Glasgow outcome scale'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",6.0,0.0286589,"One subject treated with EG-1962 developed right internal carotid and middle cerebral artery narrowing 5 mo after placement of EG-1962, leading to occlusion and cerebral infarction.","[{'ForeName': 'R Loch', 'Initials': 'RL', 'LastName': 'Macdonald', 'Affiliation': 'Department of Neurological Surgery, University of California, San Francisco, Fresno, California.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hänggi', 'Affiliation': 'Department of Neurosurgery, Düsseldorf University Hospital, Heinrich-Heine-Universität, Düsseldorf, Germany.'}, {'ForeName': 'Nerissa U', 'Initials': 'NU', 'LastName': 'Ko', 'Affiliation': 'Department of Neurology, University of California, San Francisco, California.'}, {'ForeName': 'Tim E', 'Initials': 'TE', 'LastName': 'Darsaut', 'Affiliation': 'Division of Neurosurgery, Department of Surgery, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Carlson', 'Affiliation': 'Department of Neurosurgery, University of New Mexico School of Medicine, Albuquerque, New Mexico.'}, {'ForeName': 'George K', 'Initials': 'GK', 'LastName': 'Wong', 'Affiliation': 'Division of Neurosurgery, Department of Surgery, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Etminan', 'Affiliation': 'University Medical Center Mannheim, Ruprecht-Karls-University Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Stephan A', 'Initials': 'SA', 'LastName': 'Mayer', 'Affiliation': 'Department of Neurology, Wayne State University School of Medicine, Detroit, Michigan.'}, {'ForeName': 'E Francois', 'Initials': 'EF', 'LastName': 'Aldrich', 'Affiliation': 'Neurological Surgery, University of Maryland Medical Center, Baltimore, Maryland.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Diringer', 'Affiliation': 'Neurological Critical Care, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ng', 'Affiliation': 'WuXi Clinical, Austin, Texas.'}, {'ForeName': 'Poul', 'Initials': 'P', 'LastName': 'Strange', 'Affiliation': 'Integrated Medical Development LLC, Princeton, New Jersey.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bleck', 'Affiliation': 'Department of Neurology, Northwestern University, Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Grubb', 'Affiliation': 'Neurological Surgery, University of Maryland Medical Center, Baltimore, Maryland.'}, {'ForeName': 'Jose I', 'Initials': 'JI', 'LastName': 'Suarez', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}]",Neurosurgery,['10.1093/neuros/nyaa430'] 1413,32969703,Effects of mindfulness training on posttraumatic stress symptoms from a community-based pilot clinical trial among survivors of intimate partner violence.,"Objective: Exposure to intimate partner violence (IPV) is a significant public health issue associated with deleterious mental and medical health comorbidities, including posttraumatic stress disorder (PTSD). The hallmark symptoms of posttraumatic stress (PTS), even when not meeting the threshold for a diagnosis of PTSD, appear to be underpinned by poor self-regulation in multiple domains, including emotion, cognitive control, and physiological stress. Mindfulness-based stress reduction (MBSR) holds promise for treating PTS symptoms because evidence suggests it targets these domains. The current study was a pilot randomized clinical trial designed to examine changes in emotion regulation, attentional function, and physiological stress dysregulation among women IPV survivors with elevated PTS symptoms after participation in a group-based, 8-week MBSR program. Method: In total, 29 participants were randomized to receive MBSR ( n = 19) or an active control ( n = 10). Assessments were conducted at study entry, as well as 8 and 12 weeks later. Results: Between-group differences on primary outcomes were nonsignificant; however, when exploring within groups, statistically significant decreases in PTS symptoms, F(1.37, 16.53) = 5.19, p < .05, and emotion dysregulation, F(1.31, 14.46) = 9.36, p < .01, were observed after MBSR but not after the control intervention. Further, decreases in PTSD and emotion dysregulation were clinically significant for MBSR participants but not control participants. Conclusions: These preliminary data signal that MBSR may improve PTS symptoms and emotion regulation and suggest further study of the effectiveness of PTSD interventions guided by integrative models of MBSR mechanisms and psychophysiological models of stress regulation. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Further, decreases in PTSD and emotion dysregulation were clinically significant for MBSR participants but not control participants. ","['women IPV survivors with elevated PTS symptoms after participation in a group-based, 8-week MBSR program', 'intimate partner violence (IPV', 'survivors of intimate partner violence', '29 participants']","['mindfulness training', 'MBSR', 'active control', 'Mindfulness-based stress reduction (MBSR']","['posttraumatic stress symptoms', 'PTSD and emotion dysregulation', 'PTS symptoms and emotion regulation', 'PTS symptoms', 'emotion regulation, attentional function, and physiological stress dysregulation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0151872', 'cui_str': 'Prothrombin time increased'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449430', 'cui_str': 'Physiological stress'}]",29.0,0.0230815,"Further, decreases in PTSD and emotion dysregulation were clinically significant for MBSR participants but not control participants. ","[{'ForeName': 'Autumn M', 'Initials': 'AM', 'LastName': 'Gallegos', 'Affiliation': 'Department of Psychiatry, University of Rochester Medical Center.'}, {'ForeName': 'Kathi L', 'Initials': 'KL', 'LastName': 'Heffner', 'Affiliation': 'School of Nursing, University of Rochester Medical Center.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cerulli', 'Affiliation': 'Department of Psychiatry, University of Rochester Medical Center.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Luck', 'Affiliation': 'Department of Medical Humanities and Bioethics, University of Rochester Medical Center.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'McGuinness', 'Affiliation': 'Department of Psychology, University of Rochester.'}, {'ForeName': 'Wilfred R', 'Initials': 'WR', 'LastName': 'Pigeon', 'Affiliation': 'Department of Psychiatry, University of Rochester Medical Center.'}]","Psychological trauma : theory, research, practice and policy",['10.1037/tra0000975'] 1414,32975679,"Effect of Empagliflozin on Liver Steatosis and Fibrosis in Patients With Non-Alcoholic Fatty Liver Disease Without Diabetes: A Randomized, Double-Blind, Placebo-Controlled Trial.","INTRODUCTION Despite the high prevalence of non-alcoholic fatty liver disease (NAFLD) and its associated co-morbidities, no efficient treatment in a high percentage of individuals is available. Beneficial effects of sodium-glucose co-transporter 2 inhibitors on fatty liver have been investigated in people with type 2 diabetes (T2DM). The aim of this study was to explore the effect of empagliflozin on liver steatosis and fibrosis in patients with NAFLD without T2DM. METHODS In this prospective randomized, double-blind, placebo-controlled clinical trial, participants with NAFLD were randomized to empagliflozin (10 mg/day) (n = 43) or placebo (n = 47) for 24 weeks. Hepatic steatosis and fibrosis were assessed using transient elastography to measure the controlled attenuation parameter (CAP) and liver stiffness measurement (LSM). The primary outcome was the change in CAP score at 24 weeks. RESULTS There was significant decrease in CAP score in both groups but no significant difference was observed between the two groups (P = 0.396). LSM was significantly decreased in the empagliflozin-treated group (6.03 ± 1.40 to 5.33 ± 1.08 kPa; P = 0.001), while no change was found in the placebo group. In subgroups analysis of patients with significant steatosis at baseline (CAP ≥ 302 dB/m), steatosis significantly improved in the empagliflozin group (37.2% vs. 17%; P = 0.035). There was a significant decrease in the grade of liver fat on visual analysis of ultrasound images, AST, ALT, and fasting insulin levels in the empagliflozin group, while no changes were observed in the placebo group. CONCLUSIONS Empagliflozin improves liver steatosis and, more importantly, measures of liver fibrosis in patients with NAFLD without T2DM. TRIAL REGISTRATION ClinicalTrials.gov identifier, IRCT20190122042450N1.",2020,"There was a significant decrease in the grade of liver fat on visual analysis of ultrasound images, AST, ALT, and fasting insulin levels in the empagliflozin group, while no changes were observed in the placebo group. ","['people with type\xa02 diabetes (T2DM', 'Without Diabetes', 'participants with NAFLD', '302\xa0dB/m', 'Patients With Non-Alcoholic Fatty Liver Disease', 'patients with NAFLD without T2DM', 'patients with significant steatosis at baseline (CAP\u2009≥']","['empagliflozin', 'placebo', 'sodium-glucose co-transporter\xa02 inhibitors', 'Empagliflozin', 'Placebo']","['change in CAP score', 'controlled attenuation parameter (CAP) and liver stiffness measurement (LSM', 'Hepatic steatosis and fibrosis', 'grade of liver fat on visual analysis of ultrasound images, AST, ALT, and fasting insulin levels', 'Liver Steatosis and Fibrosis', 'LSM', 'liver fibrosis', 'liver steatosis and fibrosis', 'liver steatosis', 'CAP score']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}]",,0.63044,"There was a significant decrease in the grade of liver fat on visual analysis of ultrasound images, AST, ALT, and fasting insulin levels in the empagliflozin group, while no changes were observed in the placebo group. ","[{'ForeName': 'Hoda', 'Initials': 'H', 'LastName': 'Taheri', 'Affiliation': 'Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Malek', 'Affiliation': 'Research Center for Prevention of Cardiovascular Disease, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences (IUMS), Tehran, Iran. malek.m@iums.ac.ir.'}, {'ForeName': 'Faramarz', 'Initials': 'F', 'LastName': 'Ismail-Beigi', 'Affiliation': 'Department of Medicine, Case Western Reserve University, University Hospitals Cleveland Medical Center, Cleveland, OH, 44106, USA.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Zamani', 'Affiliation': 'Gastrointestinal and Liver Disease Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Masoudreza', 'Initials': 'M', 'LastName': 'Sohrabi', 'Affiliation': 'Gastrointestinal and Liver Disease Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Reza Babaei', 'Affiliation': 'Department of Interventional Radiology, Firouzgar Hospital, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Mohammad E', 'Initials': 'ME', 'LastName': 'Khamseh', 'Affiliation': 'Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}]",Advances in therapy,['10.1007/s12325-020-01498-5'] 1415,32973113,Staged angioplasty versus regular carotid artery stenting in patients with carotid artery stenosis at high risk of hyperperfusion: a randomised clinical trial.,"BACKGROUND AND PURPOSE Hyperperfusion (HP) is a devastating complication associated with carotid artery stenting (CAS) or endarterectomy. The efficacy and safety of staged angioplasty (SAP) in patients with CAS at high risk of HP remains unclear. We sought to determine whether SAP is superior to regular CAS in patients with high risk of HP. METHODS A randomised, multicentre open-label clinical trial with blinded outcome assessment (STEP) was conducted. Patients with severe carotid stenosis at high risk of HP were randomly assigned (1:1) to the SAP or regular CAS group. The primary endpoint was hyperperfusion syndrome (HPS) and intracerebral haemorrhage (ICH) within 30 days after the procedure. RESULTS From November 2014 to January 2017, a total of 64 patients were enrolled in 11 centres. 33 patients were allocated to the SAP group and 31 to the regular CAS group. At 30 days, the rate of primary endpoint was 0.0% (0/33) in the SAP group and 9.7% (3/31) in the regular CAS group (absolute risk reduction (ARR), 9.7%; 95% CI -20.1% to 0.7%; p=0.11). As one of the secondary endpoints, the incidence of HP phenomenon (HPP) was lower in the SAP group than the regular CAS group (0.0% vs 22.6%, ARR,-22.6%; 95% CI -36.8% to -10.2%; p=0.04). CONCLUSION The rate of HPS and ICH was not significantly lower in SAP group; the extended secondary endpoint of HPP, however, significantly reduced, which suggested that SAP may be a safe and effective carotid revascularisation procedure to prevent HP. TRIAL REGISTRATION NUMBER NCT02224209.",2021,"The rate of HPS and ICH was not significantly lower in SAP group; the extended secondary endpoint of HPP, however, significantly reduced, which suggested that SAP may be a safe and effective carotid revascularisation procedure to prevent HP. ","['Patients with severe carotid stenosis at high risk of HP', 'From November 2014 to January 2017, a total of 64 patients were enrolled in 11 centres', 'patients with carotid artery stenosis at high risk of hyperperfusion', '33 patients', 'patients with CAS at high risk of HP remains unclear', 'patients with high risk of HP']","['staged angioplasty (SAP', 'SAP', 'SAP or regular CAS', 'carotid artery stenting (CAS) or endarterectomy', 'Staged angioplasty versus regular carotid artery stenting']","['hyperperfusion syndrome (HPS) and intracerebral haemorrhage (ICH', 'rate of HPS and ICH', 'efficacy and safety', 'incidence of HP phenomenon (HPP', 'rate of primary endpoint']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007282', 'cui_str': 'Carotid artery stenosis'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0850458', 'cui_str': 'Carotid stent'}]","[{'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}, {'cui': 'C0850458', 'cui_str': 'Carotid stent'}, {'cui': 'C0014098', 'cui_str': 'Endarterectomy'}]","[{'cui': 'C1611713', 'cui_str': 'Cerebral hyperperfusion syndrome'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0520739', 'cui_str': 'Hereditary pyropoikilocytosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]",64.0,0.230252,"The rate of HPS and ICH was not significantly lower in SAP group; the extended secondary endpoint of HPP, however, significantly reduced, which suggested that SAP may be a safe and effective carotid revascularisation procedure to prevent HP. ","[{'ForeName': 'Dapeng', 'Initials': 'D', 'LastName': 'Mo', 'Affiliation': 'Interventional Neuroradiology, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Baixue', 'Initials': 'B', 'LastName': 'Jia', 'Affiliation': 'Interventional Neuroradiology, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Huaizhang', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Yaxuan', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': ""Neurology, Shaanxi Provincial People's Hospital, Xi'an, China.""}, {'ForeName': 'Qingan', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Neurosurgery, Harbin Medical University Fourth Hospital, Harbin, China.'}, {'ForeName': 'Chengzhe', 'Initials': 'C', 'LastName': 'Fan', 'Affiliation': 'Neurology, Beijing An Zhen Hospital, Beijing, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Deng', 'Affiliation': ""Neurosurgery, Tangdu Hospital, The Second Affiliated Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Jinglin', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': 'Neurology, Daxing Teaching Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Neurology, Shandong University Qilu Hospital, Jinan, China.'}, {'ForeName': 'Changchun', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'Neurology, Baotou Central Hospital, Baotou, China.'}, {'ForeName': 'Guilian', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': ""Neurology, Xi'an Jiaotong University Second Affiliated Hospital, Xi'an, China.""}, {'ForeName': 'Hanjun', 'Initials': 'H', 'LastName': 'Du', 'Affiliation': 'Neurology, Peking University Shougang Hospital, Beijing, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Ma', 'Affiliation': 'Interventional Neuroradiology, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Gao', 'Affiliation': 'Interventional Neuroradiology, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Interventional Neuroradiology, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Ligang', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'Interventional Neuroradiology, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Lian', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Interventional Neuroradiology, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Guangge', 'Initials': 'G', 'LastName': 'Peng', 'Affiliation': 'Interventional Neuroradiology, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Yilong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Zhongrong', 'Initials': 'Z', 'LastName': 'Miao', 'Affiliation': 'Interventional Neuroradiology, Beijing Tiantan Hospital, Beijing, China doctorzhongrongm@126.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke and vascular neurology,['10.1136/svn-2020-000391'] 1416,32979027,Like clouds in a windy sky: Mindfulness training reduces negative affect reactivity in daily life in a randomized controlled trial.,"While prior research has found mindfulness to be linked with emotional responses to events, less is known about this effect in a non-clinical sample. Even less is known regarding the mechanisms of the underlying processes: It is unclear whether participants who exhibit increased acceptance show decreased emotional reactivity (i.e., lower affective responses towards events overall) or a speedier emotional recovery (i.e., subsequent decrease in negative affect) due to adopting an accepting stance. To address these questions, we re-analysed two Ambulatory Assessment data sets. The first (N Study1 = 125) was a 6-week randomized controlled trial (including a 40-day ambulatory assessment); the second (N Study2 = 175) was a 1-week ambulatory assessment study. We found state mindfulness to be more strongly associated with emotional reactivity than with recovery, and that only emotional reactivity was significantly dampened by mindfulness training. Regarding the different facets of mindfulness, we found that the strongest predictor of both emotional reactivity and recovery was non-judgemental acceptance. Finally, we found that being aware of one's own thoughts and behaviour could be beneficial or detrimental for emotional recovery, depending on whether participants accepted their thoughts and emotions. Together, these findings provide evidence for predictions derived from the monitoring and acceptance theory.",2021,"We found state mindfulness to be more strongly associated with emotional reactivity than with recovery, and that only emotional reactivity was significantly dampened by mindfulness training.",[],['40-day ambulatory assessment'],['emotional reactivity'],[],"[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",,0.0324028,"We found state mindfulness to be more strongly associated with emotional reactivity than with recovery, and that only emotional reactivity was significantly dampened by mindfulness training.","[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Wenzel', 'Affiliation': 'Institute of Psychology, Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Zarah', 'Initials': 'Z', 'LastName': 'Rowland', 'Affiliation': 'Institute of Psychology, Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kubiak', 'Affiliation': 'Institute of Psychology, Johannes Gutenberg University, Mainz, Germany.'}]",Stress and health : journal of the International Society for the Investigation of Stress,['10.1002/smi.2989'] 1417,32979383,Routine Early Antibiotic Use in SymptOmatic Preterm Neonates: A Pilot Randomized Controlled Trial.,We enrolled 98 infants (gestational age <33 weeks) in a pilot randomized trial of antibiotics vs no antibiotics; 55 were randomized (lower maternal infectious risk; symptoms expected for gestation). Adverse events did not differ significantly between the randomization arms. This trial establishes a framework for a larger multicentered trial.,2021,,['SymptOmatic Preterm Neonates (REASON'],[],[],"[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}]",[],[],,0.33529,,"[{'ForeName': 'J Lauren', 'Initials': 'JL', 'LastName': 'Ruoss', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida, Gainesville, FL. Electronic address: lruoss@ufl.edu.'}, {'ForeName': 'Catalina', 'Initials': 'C', 'LastName': 'Bazacliu', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida, Gainesville, FL.'}, {'ForeName': 'Jordan T', 'Initials': 'JT', 'LastName': 'Russell', 'Affiliation': 'Department of Microbiology and Cell Science, Institute of Food and Agricultural Sciences, University of Florida, Gainesville, FL.'}, {'ForeName': 'Diomel de la', 'Initials': 'D', 'LastName': 'Cruz', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida, Gainesville, FL.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida, Gainesville, FL.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Gurka', 'Affiliation': 'Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, FL.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Filipp', 'Affiliation': 'Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, FL.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Polin', 'Affiliation': 'Department of Pediatrics, College of Physicians and Surgeons, Columbia University, New York, NY.'}, {'ForeName': 'Eric W', 'Initials': 'EW', 'LastName': 'Triplett', 'Affiliation': 'Department of Microbiology and Cell Science, Institute of Food and Agricultural Sciences, University of Florida, Gainesville, FL.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Neu', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida, Gainesville, FL.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.09.056'] 1418,32980725,Radiomic features of magnetic resonance images as novel preoperative predictive factors of bone invasion in meningiomas.,"PURPOSE Bone invasion in meningiomas is a prognostic determinant, and a priori knowledge may alter surgical techniques. Here, we aim to predict bone invasion in meningiomas using radiomic signatures based on preoperative, contrast-enhanced T1-weighted (T1C) and T2-weighted (T2) magnetic resonance imaging (MRI). METHODS In this retrospective study, 490 patients diagnosed with meningiomas, including WHO grade I (448cases), grade II (38cases), and grade III (4cases), were enrolled and 213 out of 490 cases (43.5 %) had bone invasion. The patients were randomly divided into training (n = 343) and test (n = 147) datasets at a 7:3 ratio. For each patient, 1227 radiomic features were extracted from T1C and T2, respectively. Spearman's correlation and least absolute shrinkage and selection operator (LASSO) regression analyses were performed to select the most informative features. Subsequently, a 5-fold cross-validation was used to compare the performance of different classification algorithms, and logistic regression was chosen to predict the risk of bone invasion. RESULTS Eight radiomic features were selected from T1C and T2 respectively, and three models were built using radiomic features. The radiomic models derived from T1C alone or a combination of T1C and T2 had the best performance in predicting risk of bone invasion, with areas under the curve in the training dataset of 0.714 [95 % CI, 0.660-0.768] and 0.722 [95 % CI, 0.668-0.776] and in the test datasets of 0.715 [95 % CI, 0.632-0.798] and 0.713 [95 % CI, 0.628-0.798], respectively. CONCLUSIONS The radiomic model may aid clinicians with preoperative prediction of bone invasion by meningiomas, which can help in predicting prognosis and devising surgical strategies.",2020,"The radiomic models derived from T1C alone or a combination of T1C and T2 had the best performance in predicting risk of bone invasion, with areas under the curve in the training dataset of 0.714 [95 % CI, 0.660-0.768] and 0.722","['490 patients diagnosed with meningiomas, including WHO grade I (448cases), grade II (38cases), and grade III (4cases), were enrolled and 213 out of 490 cases (43.5 %) had bone invasion', 'bone invasion in meningiomas']","['magnetic resonance images', 'radiomic signatures based on preoperative, contrast-enhanced T1-weighted (T1C) and T2-weighted (T2) magnetic resonance imaging (MRI']",['risk of bone invasion'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0025286', 'cui_str': 'Meningioma'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}]","[{'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}]",490.0,0.0309829,"The radiomic models derived from T1C alone or a combination of T1C and T2 had the best performance in predicting risk of bone invasion, with areas under the curve in the training dataset of 0.714 [95 % CI, 0.660-0.768] and 0.722","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Second Clinical School, Lanzhou University, Lanzhou, China; Department of Radiology, Lanzhou University Second Hospital, Lanzhou, China; Key Laboratory of Medical Imaging of Gansu Province, Lanzhou, China.'}, {'ForeName': 'Jianqing', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Philips Healthcare, Shanghai, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Han', 'Affiliation': 'Second Clinical School, Lanzhou University, Lanzhou, China; Department of Radiology, Lanzhou University Second Hospital, Lanzhou, China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Second Clinical School, Lanzhou University, Lanzhou, China; Department of Radiology, Lanzhou University Second Hospital, Lanzhou, China.'}, {'ForeName': 'Yuntai', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Second Clinical School, Lanzhou University, Lanzhou, China; Department of Radiology, Lanzhou University Second Hospital, Lanzhou, China.'}, {'ForeName': 'Guojin', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Second Clinical School, Lanzhou University, Lanzhou, China; Department of Radiology, Lanzhou University Second Hospital, Lanzhou, China.'}, {'ForeName': 'Junlin', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Second Clinical School, Lanzhou University, Lanzhou, China; Department of Radiology, Lanzhou University Second Hospital, Lanzhou, China. Electronic address: lzuzjl601@163.com.'}]",European journal of radiology,['10.1016/j.ejrad.2020.109287'] 1419,32990858,Efficacy of platelet-rich plasma in the treatment of hemiplegic shoulder pain.,"OBJECTIVE The aim of this study was to examine the effects of platelet-rich plasma (PRP) on pain and functional outcomes in patients with hemiplegic shoulder pain. We compared the effects of PRP against saline solution by designing a double blind, randomized, prospective study. DESIGN Forty-four patients with hemiplegia were included in this study. All patients received a total of 3 injections, 1 week apart. The first group received PRP injections while the second group received placebo injections. After 3 months of follow-up, 40 patients completed the trial. Primary outcome measure was movement-induced pain score (VAS), and secondary outcome measures were spontaneous pain score, shoulder passive range of motion (ROM), functional independence measure score, and the amount of paracetamol used. All subjects were evaluated at baseline, 1 week, 1 month, and 3 months after the completion of the last injection. RESULTS Both groups showed an improvement in spontaneous and movement-related pain scores and shoulder passive ROM values on 1st and 3rd month visits (p < 0.05). No significance difference was detected between groups (p > 0.05). Similarly, FIM scores improved significantly in both groups (p < 0.05) but no difference was found between groups. Paracetamol use did not differ significantly between groups. CONCLUSION The PRP injections were found not to be superior to placebo. Improvements in both groups can be attributed to the use of rehabilitation techniques and exercises in all patients. There is still need for further research to show whether PRP is a treatment option in the course of hemiplegic shoulder pain. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03931824.",2021,Both groups showed an improvement in spontaneous and movement-related pain scores and shoulder passive ROM values on 1st and 3rd month visits (p < 0.05).,"['patients with hemiplegic shoulder pain', 'Forty-four patients with hemiplegia', 'hemiplegic shoulder pain']","['PRP injections', 'placebo injections', 'platelet-rich plasma (PRP', 'PRP', 'placebo', 'Paracetamol', 'platelet-rich plasma', 'PRP against saline solution']","['movement-induced pain score (VAS), and secondary outcome measures were spontaneous pain score, shoulder passive range of motion (ROM), functional independence measure score, and the amount of paracetamol used', 'spontaneous and movement-related pain scores and shoulder passive ROM values', 'FIM scores', 'pain and functional outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C1997216', 'cui_str': 'Spontaneous pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C4274266', 'cui_str': 'Functional Independence Measure score'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",44.0,0.255828,Both groups showed an improvement in spontaneous and movement-related pain scores and shoulder passive ROM values on 1st and 3rd month visits (p < 0.05).,"[{'ForeName': 'Asude', 'Initials': 'A', 'LastName': 'Uzdu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Ege University Faculty of Medicine, Bornova, Izmir, Turkey.'}, {'ForeName': 'Yeşim', 'Initials': 'Y', 'LastName': 'Kirazlı', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Ege University Faculty of Medicine, Bornova, Izmir, Turkey.'}, {'ForeName': 'Hale', 'Initials': 'H', 'LastName': 'Karapolat', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Ege University Faculty of Medicine, Bornova, Izmir, Turkey.'}, {'ForeName': 'Burcu', 'Initials': 'B', 'LastName': 'Unlu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Ege University Faculty of Medicine, Bornova, Izmir, Turkey.'}, {'ForeName': 'Göksel', 'Initials': 'G', 'LastName': 'Tanıgör', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Ege University Faculty of Medicine, Bornova, Izmir, Turkey. gtanigor@windowslive.com.'}, {'ForeName': 'Funda Atamaz', 'Initials': 'FA', 'LastName': 'Çalış', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Ege University Faculty of Medicine, Bornova, Izmir, Turkey.'}]",Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology,['10.1007/s10072-020-04710-0'] 1420,32956964,Efficacy of learning through play plus intervention to reduce maternal depression in women with malnourished children: A randomized controlled trial from Pakistan ✰ .,"BACKGROUND The risk factors and adverse outcomes related to maternal depression and child malnutrition are a leading cause of morbidity and mortality in low and middle-income countries (LMIC) including Pakistan. Above 25% of women suffer from maternal depression. Up to 50% children are under-nourished which contributes to 35% of all under-5 deaths in the country. AIM To determine the efficacy of Learning through Play Plus Thinking Healthy Program (LTP Plus) intervention to reduce maternal depression in mothers with undernourished children. METHODS In this randomised controlled trial, all eligible mothers presenting to the paediatric departments were invited to participate in the study. Out of the total 256 mothers screened, 107 were included, 54 of those were randomly allocated to LTP Plus group and 53 to treatment as usual (TAU). Edinburgh Postnatal Depression Scale (EPDS) was used to screen for depression. Hamilton Depression Rating Scale (HDRS), Maternal Attachment Inventory (MAI), Social Support Scale (OSLO-3) and the Euro-QoL (EQ-5D) were used to measure the severity of depression, mother-child attachment, level of support and health related quality of life dimensions. Assessments were completed at baseline, end of intervention (3 months from baseline) and at 6 months from baseline. RESULTS Mothers in the LTP Plus group significantly showed improvements in depression (p<0.001), social support (p = 0.02) and quality of life (p<0.001) at the end of the intervention (LTP Plus), as compared to the TAU group, which were sustained up to 6 months after baseline. CONCLUSION The outcomes of LTP Plus intervention for mothers of malnourished children show promising results in reducing maternal depression and improving child outcomes. A full trial with longer-term outcomes and cost-effectiveness needs to be conducted.",2021,"RESULTS Mothers in the LTP Plus group significantly showed improvements in depression (p<0.001), social support (p = 0.02) and quality of life (p<0.001) at the end of the intervention (LTP Plus), as compared to the TAU group, which were sustained up to 6 months after baseline. ","['Out of the total 256 mothers screened, 107 were included, 54 of those', 'mothers with undernourished children', 'eligible mothers presenting to the paediatric departments were invited to participate in the study', 'mothers of malnourished children', 'women with malnourished children']","['Learning through Play Plus Thinking Healthy Program (LTP Plus) intervention', 'learning through play plus intervention', 'LTP Plus group and 53 to treatment as usual (TAU', 'LTP Plus intervention']","['Edinburgh Postnatal Depression Scale (EPDS', 'depression (p<0.001), social support', 'maternal depression', 'severity of depression, mother-child attachment, level of support and health related quality of life dimensions', 'maternal depression and improving child outcomes', 'quality of life', 'Hamilton Depression Rating Scale (HDRS), Maternal Attachment Inventory (MAI), Social Support Scale (OSLO-3) and the Euro-QoL (EQ-5D']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0587482', 'cui_str': 'Pediatric department'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0206249', 'cui_str': 'Long-Term Potentiation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1533125', 'cui_str': 'Euro'}]",,0.148806,"RESULTS Mothers in the LTP Plus group significantly showed improvements in depression (p<0.001), social support (p = 0.02) and quality of life (p<0.001) at the end of the intervention (LTP Plus), as compared to the TAU group, which were sustained up to 6 months after baseline. ","[{'ForeName': 'Nusrat', 'Initials': 'N', 'LastName': 'Husain', 'Affiliation': 'University of Manchester United Kingdom; Lancashire Care NHS Foundation Trust. Electronic address: Nusrat.husain@manchester.ac.uk.'}, {'ForeName': 'Tayyeba', 'Initials': 'T', 'LastName': 'Kiran', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Sadia', 'Initials': 'S', 'LastName': 'Shah', 'Affiliation': 'Lancashire Care NHS Foundation Trust; Pakistan Institute of Living and Learning.'}, {'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'University of Liverpool United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Raza-Ur-Rehman', 'Affiliation': 'Dow University of Health Sciences.'}, {'ForeName': 'Qamar', 'Initials': 'Q', 'LastName': 'Saeed', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Shehla', 'Initials': 'S', 'LastName': 'Naeem', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bassett', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Husain', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Sami Ul', 'Initials': 'SU', 'LastName': 'Haq', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Farhat', 'Initials': 'F', 'LastName': 'Jaffery', 'Affiliation': 'Karachi Medical and Dental College Pakistan.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Cohen', 'Affiliation': 'University of Toronto.'}, {'ForeName': 'Farooq', 'Initials': 'F', 'LastName': 'Naeem', 'Affiliation': 'Centre for Addiction & Mental Health, Toronto, Canada.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Chaudhry', 'Affiliation': 'Pakistan Institute of Living and Learning.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.001'] 1421,32959481,A guided Internet-delivered intervention for adjustment disorders: A randomized controlled trial.,"Evidence of self-help interventions for adjustment disorder (AjD) is limited. This study aims at testing in a randomized controlled trial (RCT) the effectiveness of a disorder-specific, Internet-delivered cognitive-behavioural therapy (ICBT) intervention for AjD. Participants were randomly allocated to either an ICBT with brief weekly telephone support (n = 34) or a waiting list group (n = 34). Beck's inventories for depression and anxiety were used as primary outcomes. The secondary outcomes were AjD symptoms, post-traumatic growth, positive and negative affect, and quality of life. In all, 76.5% of the participants completed the intervention. Compared with the control group, participants in the intervention condition showed significantly greater improvement in all outcomes (Cohen's d ranged from 0.54 to 1.21) except in anxiety symptoms measured by Beck Anxiety Inventory (d = 0.27). Only ICBT group showed a significant improvement in post-traumatic growth, positive and negative affect, and quality of life. The number of cases that achieved clinically meaningful change in all outcome measures was also higher in the ICBT group. All therapeutic gains were maintained at 3-, 6- and 12-month follow-ups. The current study provides evidence on the effectiveness of ICBT interventions to reduce the impact of AjD. Results suggest that brief self-help intervention with minimal therapist support is more effective than the mere passage of time in reducing the distress symptoms associated to the disorder and also can confer additional benefits.",2021,"Compared to the control group, participants in the intervention condition showed significantly greater improvement in all outcomes (Cohen's d ranged from.54 to 1.21) except in anxiety symptoms measured by Beck's Anxiety Inventory (d=.27).",['AjD. Participants'],"['ICBT with brief weekly telephone support (n=34) or a waiting list group', 'Guided Internet-delivered intervention', 'ICBT interventions', 'disorder-specific, Internet-delivered CBT (ICBT) intervention', 'ICBT']","['posttraumatic growth, positive and negative affect, and quality of life', 'anxiety symptoms', 'adjustment disorder symptoms, posttraumatic growth, positive and negative affect, and quality of life']","[{'cui': 'C0001546', 'cui_str': 'Adjustment disorder'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]","[{'cui': 'C4704809', 'cui_str': 'Posttraumatic Growth'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0001546', 'cui_str': 'Adjustment disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0662501,"Compared to the control group, participants in the intervention condition showed significantly greater improvement in all outcomes (Cohen's d ranged from.54 to 1.21) except in anxiety symptoms measured by Beck's Anxiety Inventory (d=.27).","[{'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Rachyla', 'Affiliation': 'Department of Basic, Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón, Spain.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Mor', 'Affiliation': 'Department of Basic, Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón, Spain.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health research institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Botella', 'Affiliation': 'Department of Basic, Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón, Spain.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Castilla', 'Affiliation': 'CIBER of Physiopathology of Obesity and Nutrition (CIBERObn), Madrid, Spain.'}, {'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'Quero', 'Affiliation': 'Department of Basic, Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón, Spain.'}]",Clinical psychology & psychotherapy,['10.1002/cpp.2518'] 1422,32961065,Feasibility and effects on the gut microbiota of a 12-week high-intensity interval training plus lifestyle education intervention on inactive adults with celiac disease.,"This study assessed the feasibility and benefits of high-intensity interval training (HIIT) plus lifestyle education among inactive adults with celiac disease. Forty-one participants were randomized to receive the intervention (HIIT plus lifestyle education; HIIT+) for 12 weeks or waitlist control (WLC). Testing was completed at baseline, immediately post-intervention, and 3 months post-intervention. Generalized estimating equations were used to assess changes in the outcome variables over time between the groups. Mean percent of age-predicted maximum heart rate was 97.9% and average rating of perceived exertion was 6.33 (out of 10) during HIIT intervals. Following the intervention, the HIIT+ showed enrichment in relative abundance of Parabacteroides and Defluviitaleaceae_UCG_011 while WLC showed enrichment in relative abundance of Roseburia intestinalis , Klebsiella , and Adlercreutzia . A unique set of taxa were differentially abundant between the groups at 3 months post-intervention. HIIT+ participants experienced a reduction in resting heart rate (-6.6 bpm) immediately post-intervention compared with WLC. Further research is needed to establish an optimal HIIT protocol that may improve maximal oxygen uptake and metabolic syndrome biomarkers. Findings from this pilot study provide preliminary evidence that an HIIT intervention is feasible for inactive adults with celiac disease and leads to favourable changes in resting heart rate alongside potentially beneficial shifts in gut microbiota. Trial registration number: ClinicalTrials.gov number NCT03520244. Novelty: HIIT leads to potentially beneficial changes in the gut microbiota of adults with celiac disease. An HIIT exercise intervention is feasible and well tolerated for patients with celiac disease.",2021,Findings from this pilot study provide preliminary evidence that a HIIT+ intervention is feasible for inactive adults with celiac disease and leads to favourable changes in resting HR alongside potentially beneficial shifts in gut microbiota.,"['inactive adults with celiac disease', 'adults with celiac disease', 'Inactive Adults with Celiac Disease', '41 participants', 'patients with celiac disease']","['HIIT+ intervention', '12-Week High Intensity Interval Training plus Lifestyle Education Intervention', 'high intensity interval training (HIIT) plus lifestyle education', 'intensity interval training exercise intervention', 'High intensity interval training', 'intervention (HIIT+) for 12-weeks or waitlist control (WLC']","['relative abundance of Roseburia intestinalis, Klebsiella and Adlercreutzia', 'resting heart rate', 'maximum heart rate']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0007570', 'cui_str': 'Celiac disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C1196244', 'cui_str': 'Roseburia intestinalis'}, {'cui': 'C0022727', 'cui_str': 'Klebsiella'}, {'cui': 'C2280992', 'cui_str': 'Adlercreutzia'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}]",41.0,0.0533807,Findings from this pilot study provide preliminary evidence that a HIIT+ intervention is feasible for inactive adults with celiac disease and leads to favourable changes in resting HR alongside potentially beneficial shifts in gut microbiota.,"[{'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Warbeck', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, AB T2N 1N4, Canada.'}, {'ForeName': 'A Justine', 'Initials': 'AJ', 'LastName': 'Dowd', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, AB T2N 1N4, Canada.'}, {'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Kronlund', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, AB T2N 1N4, Canada.'}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Parmar', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, AB T2N 1N4, Canada.'}, {'ForeName': 'Julia T', 'Initials': 'JT', 'LastName': 'Daun', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, AB T2N 1N4, Canada.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Wytsma-Fisher', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, AB T2N 1N4, Canada.'}, {'ForeName': 'Guillaume Y', 'Initials': 'GY', 'LastName': 'Millet', 'Affiliation': 'Univ Lyon, UJM-Saint-Etienne, Inter-university Laboratory of Human Movement Biology, EA 7424, F-42023, Saint-Etienne, France.'}, {'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Schick', 'Affiliation': 'International Microbiome Centre, Snyder Institute for Chronic Diseases, University of Calgary, Calgary, AB T2N 1N4, Canada.'}, {'ForeName': 'Raylene A', 'Initials': 'RA', 'LastName': 'Reimer', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, AB T2N 1N4, Canada.'}, {'ForeName': 'Tak', 'Initials': 'T', 'LastName': 'Fung', 'Affiliation': 'Research Computing Services, Information Technologies, University of Calgary, Calgary, AB T2N 1N4, Canada.'}, {'ForeName': 'S Nicole', 'Initials': 'SN', 'LastName': 'Culos-Reed', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, AB T2N 1N4, Canada.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2020-0459'] 1423,32967068,Effect of Vitamin D Supplement on Vulvovaginal Atrophy of the Menopause.,"The effects of oral vitamin D supplements on vaginal health in postmenopausal women with vulvovaginal atrophy (VVA) was evaluated. A double-blinded, randomized placebo-controlled trial was conducted for 12 weeks to investigate changes on vaginal maturation index (VMI), vaginal pH, and the visual analog scale (VAS) of VVA symptoms. The vitamin D group received oral ergocalciferol, at 40,000 IU per week, while the placebo group received an identical placebo capsule. Eighty postmenopausal women were enrolled. There were no significant differences in baseline characteristics between both groups. In an intention-to-treat analysis, VMI, vaginal pH, and VAS of VVA symptoms showed no significant differences between both groups at the six and 12 weeks. However, the mean difference of VMI in the vitamin D group between baseline and at six weeks showed significant improvement (5.5 + 16.27, p <0.05). Moreover, the mean vaginal pH and VAS of VVA patients in the vitamin D group were significantly improved at both six and 12 weeks compared to baseline. The oral vitamin D supplementation for 12 weeks potentially improves vaginal health outcomes in postmenopausal women with VVA symptoms, demonstrated by the improved mean VMI, vaginal pH, and VAS at six and 12 weeks between baseline, however, no significant differences were observed from the placebo treatment.",2020,"Moreover, the mean vaginal pH and VAS of VVA patients in the vitamin D group were significantly improved at both six and 12 weeks compared to baseline.","['Eighty postmenopausal women were enrolled', 'postmenopausal women with vulvovaginal atrophy (VVA', 'postmenopausal women with VVA symptoms']","['oral ergocalciferol', 'Vitamin D Supplement', 'vitamin D', 'oral vitamin D supplements', 'placebo capsule', 'placebo', 'oral vitamin D supplementation']","['VMI, vaginal pH, and VAS of VVA symptoms', 'vaginal health', 'Vulvovaginal Atrophy of the Menopause', 'mean VMI, vaginal pH, and VAS', 'vaginal health outcomes', 'VMI', 'mean vaginal pH and VAS', 'vaginal maturation index (VMI), vaginal pH, and the visual analog scale (VAS) of VVA symptoms']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0857741', 'cui_str': 'Vulvovaginal atrophy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0014695', 'cui_str': 'Ergocalciferol'}, {'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0429263', 'cui_str': 'Vaginal pH'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0857741', 'cui_str': 'Vulvovaginal atrophy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",80.0,0.39508,"Moreover, the mean vaginal pH and VAS of VVA patients in the vitamin D group were significantly improved at both six and 12 weeks compared to baseline.","[{'ForeName': 'Thawinee', 'Initials': 'T', 'LastName': 'Kamronrithisorn', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok 10400, Thailand.'}, {'ForeName': 'Jittima', 'Initials': 'J', 'LastName': 'Manonai', 'Affiliation': 'Female Pelvic Medicine and Reconstructive Surgery Unit, Department of Obstetrics & Gynaecology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok 10400, Thailand.'}, {'ForeName': 'Sakda Arj-Ong', 'Initials': 'SA', 'LastName': 'Vallibhakara', 'Affiliation': 'ASEAN Institute for Health Development, Mahidol University, Nakhon Pathom 73170, Thailand.'}, {'ForeName': 'Areepan', 'Initials': 'A', 'LastName': 'Sophonsritsuk', 'Affiliation': 'Reproductive Endocrinology and Infertility Unit, Department of Obstetrics and Gynaecology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok 10400, Thailand.'}, {'ForeName': 'Orawin', 'Initials': 'O', 'LastName': 'Vallibhakara', 'Affiliation': 'Reproductive Endocrinology and Infertility Unit, Department of Obstetrics and Gynaecology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok 10400, Thailand.'}]",Nutrients,['10.3390/nu12092876'] 1424,32967132,Vitamin D Correction Down-Regulates Serum Amyloid P Component Levels in Vitamin D Deficient Arab Adults: A Single-Arm Trial.,"Vitamin D (VD) has been observed to have anti-inflammatory properties. However, the effects of VD supplementation on the serum amyloid P component (SAP) has not been established. This study aimed to investigate the effect of VD supplementation on serum SAP levels in Arab adults. A total of 155 VD-deficient adult Saudis (56 males and 99 females) were recruited in this non-randomized, 6-month, single-arm trial. The intervention was as follows; cholecalciferol 50,000 international units (IU) every week for the first 2 months, followed by 50,000 twice a month for the next two months, and for the last two months, 1000 IU daily. Serum 25(OH)D, SAP, C-reactive protein (CRP), lipid profile, and glucose were assessed at baseline and post-intervention. At post-intervention, VD levels were significantly increased, while SAP levels significantly decreased in all study participants. Remarkably, this reduction in SAP was more significant in males than females after stratification. SAP was inversely correlated with VD overall (r = -0.17, p < 0.05), and only in males (r = -0.27, p < 0.05) after stratification according to sex after 6 months of VD supplementation. Such a relationship was not observed at baseline. VD supplementation can favorably modulate serum SAP concentrations in Arab adults, particularly in males.",2020,"At post-intervention, VD levels were significantly increased, while SAP levels significantly decreased in all study participants.","['A total of 155 VD-deficient adult Saudis (56 males and 99 females', 'Vitamin D Deficient Arab Adults', 'Arab adults, particularly in males', 'Arab adults']","['VD supplementation', 'Vitamin D Correction Down', 'Vitamin D (VD', 'cholecalciferol']","['SAP', 'serum SAP levels', 'VD levels', 'SAP levels', 'serum SAP concentrations', 'Serum 25(OH)D, SAP, C-reactive protein (CRP), lipid profile, and glucose']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0282540', 'cui_str': 'Arabs'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0002721', 'cui_str': 'Amyloid P component'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",,0.0318965,"At post-intervention, VD levels were significantly increased, while SAP levels significantly decreased in all study participants.","[{'ForeName': 'Osama E', 'Initials': 'OE', 'LastName': 'Amer', 'Affiliation': 'Chair for Biomarkers of Chronic Diseases, Biochemistry Department, College of Science, King Saud University, Riyadh 11451, Saudi Arabia.'}, {'ForeName': 'Malak N K', 'Initials': 'MNK', 'LastName': 'Khattak', 'Affiliation': 'Chair for Biomarkers of Chronic Diseases, Biochemistry Department, College of Science, King Saud University, Riyadh 11451, Saudi Arabia.'}, {'ForeName': 'Abdullah M', 'Initials': 'AM', 'LastName': 'Alnaami', 'Affiliation': 'Chair for Biomarkers of Chronic Diseases, Biochemistry Department, College of Science, King Saud University, Riyadh 11451, Saudi Arabia.'}, {'ForeName': 'Naji J', 'Initials': 'NJ', 'LastName': 'Aljohani', 'Affiliation': 'Specialized Diabetes and Endocrine Center, King Fahad Medical City, Riyadh 11525, Saudi Arabia.'}, {'ForeName': 'Nasser M', 'Initials': 'NM', 'LastName': 'Al-Daghri', 'Affiliation': 'Chair for Biomarkers of Chronic Diseases, Biochemistry Department, College of Science, King Saud University, Riyadh 11451, Saudi Arabia.'}]",Nutrients,['10.3390/nu12092880'] 1425,32971314,Quality of life after response to acute-phase cognitive therapy for recurrent depression.,"BACKGROUND Adults with major depressive disorder (MDD) often experience reduced quality of life (QOL). Efficacious acute-phase treatments, including cognitive therapy (CT) or medication, decrease depressive symptoms and, to a lesser degree, increase QOL. We tested longer-term changes in QOL after response to acute-phase CT, including the potential effects of continuation treatment for depression and time-lagged relations between QOL and depressive symptoms. METHODS Responders to acute-phase CT (N = 290) completed QOL and depressive symptom assessments repeatedly for 32 post-acute months. Higher-risk responders were randomized to 8 months of continuation treatment (CT, fluoxetine, or pill placebo) and then entered a 24-month follow-up. Lower-risk responders were only assessed for 32 months. RESULTS On average, large gains in QOL made during acute-phase CT response were maintained for 32 months. Continuation CT or fluoxetine did not improve QOL relative to pill placebo. Controlling for residual depressive symptoms, higher QOL after acute-phase CT response was a protective factor against MDD relapse and recurrence. Higher QOL predicted subsequent reductions in depressive symptom severity, but depressive symptom severity did not predict subsequent changes in QOL. LIMITATIONS Generalization of results to other patient populations, treatments, and measures is uncertain. The clinical trial was not designed to test relations between QOL and depression. Replication is needed before clinical application of these results. CONCLUSIONS Gains in QOL made during response to acute-phase CT are relatively stable and may help protect against relapse/recurrence. Continuation CT or fluoxetine may not further improve QOL among acute-phase CT responders.",2021,"Controlling for residual depressive symptoms, higher QOL after acute-phase CT response was a protective factor against MDD relapse and recurrence.","['Responders to acute-phase CT', 'Adults with major depressive disorder (MDD', 'recurrent depression', 'Higher-risk responders']","['cognitive therapy (CT', 'continuation treatment (CT, fluoxetine, or pill placebo', 'fluoxetine']","['QOL relative', 'depressive symptom severity', 'quality of life (QOL', 'QOL and depressive symptom assessments', 'QOL', 'Quality of life']","[{'cui': 'C0439557', 'cui_str': 'Acute phase'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0221480', 'cui_str': 'Recurrent depression'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",290.0,0.0234422,"Controlling for residual depressive symptoms, higher QOL after acute-phase CT response was a protective factor against MDD relapse and recurrence.","[{'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Vittengl', 'Affiliation': 'Department of Psychology, Truman State University, 100 East Normal Street, Kirksville, MO 63501-4221, USA. Electronic address: vittengl@truman.edu.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai.'}, {'ForeName': 'Abu', 'Initials': 'A', 'LastName': 'Minhajuddin', 'Affiliation': 'Department of Population and Data Sciences, University of Texas Southwestern Medical Center.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania.'}, {'ForeName': 'Robin B', 'Initials': 'RB', 'LastName': 'Jarrett', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX 75390-9149, USA. Electronic address: Robin.Jarrett@UTSouthwestern.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.059'] 1426,32971388,Perceptions of U.S. and Canadian Cannabis Package Warnings Among U.S. Adults.,"BACKGROUND Cannabis warning labels can communicate risks, but there is little research on warning perceptions and differences by product type. METHODS In a 2019 online survey, 1,000 U.S. adults (500 cannabis users and 500 cannabis non-users who used tobacco) were randomly assigned to view no warning or one of four U.S. or Canadian warnings displayed on images of packaging for dried flower or edible cannabis. The warnings described cannabis risks related to psychosis, addiction, lack of FDA oversight, and impaired driving. We used linear regression to examine perceptions of warnings and product harm as a function of product type (dried or edible) and warning. We examined which warning participants selected as most effective for discouraging youth use and impaired driving. RESULTS Participants found the addiction warning (cannabis users: B = -1.04, p < 0.001; cannabis non-users: B = 1.17, p < 0.001) and psychosis warning (users: B = -0.65, p < 0.05; non-users: B = -0.71, p < 0.05) less believable than the driving warning but indicated that they learned more from the psychosis warning than the driving warning (users: B = 0.88, p < 0.01; non-users (B = 1.60, p < 0.001). Participants viewing any warning considered smoking cannabis to be more harmful than those viewing no warning (all p < 0.05). The psychosis warning was most frequently selected as the best warning for discouraging youth use. CONCLUSIONS Warnings have the potential to educate consumers and impact cannabis harm perceptions. Warnings have similar effects across product types, potentially eliminating the need for product type-specific warnings. The association of cannabis use with risk for psychosis, a topic addressed in Canadian warnings, could be a useful topic of focus in U.S. warnings.",2020,Participants viewing any warning considered smoking cannabis to be more harmful than those viewing no warning (all p < 0.05).,"['In a 2019 online survey, 1,000 U.S. adults (500 cannabis users and 500 cannabis non-users who used tobacco', 'Perceptions of U.S. and Canadian Cannabis Package Warnings Among U.S. Adults']",['view no warning or one of four U.S. or Canadian warnings displayed on images of packaging for dried flower or edible cannabis'],"['addiction warning', 'psychosis warning']","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0556574', 'cui_str': 'Dried flowers'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}]","[{'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]",,0.0480856,Participants viewing any warning considered smoking cannabis to be more harmful than those viewing no warning (all p < 0.05).,"[{'ForeName': 'Jessica K', 'Initials': 'JK', 'LastName': 'Pepper', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA. Electronic address: jpepper@rti.org.'}, {'ForeName': 'Youn Ok', 'Initials': 'YO', 'LastName': 'Lee', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Eggers', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Allen', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Nonnemaker', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108275'] 1427,32976331,The Effect of Photographic Visual Aids in Preoperative Patient Counseling in Oculoplastic Surgery.,"PURPOSE To investigate the effect of visual supplementation and its mode of delivery in preoperative counseling of patients undergoing oculoplastic surgery. METHODS A prospective randomized controlled trial of consecutive patients undergoing oculoplastic eyebrow and eyelid surgery was conducted. Patients were randomized to an ""oral only"" group receiving routine preoperative oral counseling or an ""oral and visual"" group receiving identical counseling visually supplemented with photographs demonstrating common postoperative physical findings. Patients in the ""oral and visual"" group were further randomized to receive education from the medical team in person versus prerecorded video. Patient emotions and expectations regarding postoperative healing were assessed preoperatively and at 1 week and 2 months postoperatively. RESULTS 103 patients were included: 32 received in-person oral education, 33 received in-person oral education with photographs, and 38 received education with photographs via video. There were no significant differences in demographics or preoperative patient fear, anxiety, or preparedness. The ""oral and visual"" group expected more severe postsurgical discomfort and physical findings at postoperative day 1 and week 1. There were no significant differences between groups in surgery signup, cancellation, or triage call rates; patient expectations of postoperative months 2 and 4; or in anxiety, preparedness, or satisfaction. CONCLUSIONS Visual supplementation in preoperative counseling increases patient expectations of postoperative physical findings without escalating fear or anxiety, and has no significant impact on patient emotions, triage call rates, and satisfaction throughout their surgical experience. Preoperative education via video is perceived by patients to be equivalent to counseling in person by the surgeon.",2020,"The ""oral and visual"" group expected more severe postsurgical discomfort and physical findings at postoperative day 1 and week 1.","['103 patients were included: 32 received in-person oral education, 33 received in-person oral education with photographs, and 38 received education with photographs via video', 'Preoperative Patient Counseling in Oculoplastic Surgery', 'patients undergoing oculoplastic surgery', 'consecutive patients undergoing']","['Visual supplementation', 'visual supplementation', 'education from the medical team in person versus prerecorded video', 'oculoplastic eyebrow and eyelid surgery', 'oral only"" group receiving routine preoperative oral counseling or an ""oral and visual"" group receiving identical counseling visually supplemented with photographs demonstrating common postoperative physical findings', 'Photographic Visual Aids']","['Patient emotions and expectations regarding postoperative healing', 'patient emotions, triage call rates, and satisfaction', 'demographics or preoperative patient fear, anxiety, or preparedness', 'severe postsurgical discomfort and physical findings', 'surgery signup, cancellation, or triage call rates; patient expectations of postoperative months 2 and 4; or in anxiety, preparedness, or satisfaction']","[{'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0600047', 'cui_str': 'Patient counseled'}, {'cui': 'C1720208', 'cui_str': 'Ophthalmic plastic surgery'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0015420', 'cui_str': 'Eyebrow structure'}, {'cui': 'C0015426', 'cui_str': 'Eyelid structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0042813', 'cui_str': 'Visual Aids'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",103.0,0.0521746,"The ""oral and visual"" group expected more severe postsurgical discomfort and physical findings at postoperative day 1 and week 1.","[{'ForeName': 'Kelly H', 'Initials': 'KH', 'LastName': 'Yom', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Shriver', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Keith D', 'Initials': 'KD', 'LastName': 'Carter', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Bobby S', 'Initials': 'BS', 'LastName': 'Korn', 'Affiliation': 'Department of Ophthalmology, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Don O', 'Initials': 'DO', 'LastName': 'Kikkawa', 'Affiliation': 'Department of Ophthalmology, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Audrey C', 'Initials': 'AC', 'LastName': 'Ko', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Iowa, Iowa City, Iowa.'}]",Ophthalmic plastic and reconstructive surgery,['10.1097/IOP.0000000000001817'] 1428,32978722,A Phase I Placebo-Controlled Trial Comparing the Effects of Buprenorphine Buccal Film and Oral Oxycodone Hydrochloride Administration on Respiratory Drive.,"INTRODUCTION Buprenorphine is a partial μ-opioid receptor agonist that, unlike full μ-opioid receptor agonists, has been shown to have a ceiling effect on respiratory depression. Buprenorphine buccal film (BBF) is approved by the US Food and Drug Administration for use in patients with chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment and for whom alternative treatment options are inadequate. This study was conducted to compare the effects of BBF and immediate-release oral oxycodone hydrochloride administration on respiratory drive, as measured by the ventilatory response to hypercapnia (VRH) after drug administration. METHODS Subjects (N = 19) were men and women, ages 27-41 years, self-identifying as recreational opioid users who were not physically dependent on opioids as determined via a Naloxone Challenge Test. Respiratory drive was evaluated by measuring VRH through the assessment of the maximum decrease in minute ventilation (E max ) after administration of each treatment. The treatments utilized in this study included 300, 600, and 900 μg BBF; 30 and 60 mg orally administered oxycodone; and placebo (each separated by a 7-day washout period). Effects on respiratory drive were assessed using a double-blind, double-dummy, six-treatment, six-period, placebo-controlled, randomized crossover design. Statistical analyses were performed using a linear mixed-effects model. RESULTS The least squares mean differences in minute volume E max (L/min, versus placebo) were as follows: 300 μg BBF (+ 1.24, P = 0.529), 600 μg BBF (+ 0.23, P = 0.908), 900 μg BBF (+ 0.93, P = 0.637), 30 mg oxycodone (- 0.79, P = 0.687), and 60 mg oxycodone (- 5.23, P = 0.010). CONCLUSIONS BBF did not significantly reduce respiratory drive at any dose compared with placebo, including at the maximum available prescription dose of 900 μg. Administration of oxycodone resulted in a significant dose-dependent decrease in respiratory drive. These data suggest that BBF may be a safer treatment option than full μ-opioid receptor agonists for patients with chronic pain. TRIAL REGISTRATION ClinicalTrials.gov identifier, NCT03996694.",2020,"CONCLUSIONS BBF did not significantly reduce respiratory drive at any dose compared with placebo, including at the maximum available prescription dose of 900 μg.","['300, 600, and 900\xa0μg BBF; 30 and 60\xa0mg orally administered', 'patients with chronic pain severe', 'Subjects (N\u2009=\u200919) were men and women, ages 27-41\xa0years, self-identifying as recreational opioid users who were not physically dependent on opioids as determined via a Naloxone Challenge Test', 'patients with chronic pain']","['Buprenorphine buccal film (BBF', 'oxycodone; and placebo', 'Buprenorphine Buccal Film and Oral Oxycodone Hydrochloride', 'Buprenorphine', 'BBF', 'oxycodone hydrochloride', 'placebo', 'oxycodone', 'Placebo']","['minute ventilation (E max ', 'ventilatory response to hypercapnia (VRH', 'respiratory drive']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C4056633', 'cui_str': 'Buprenorphine Buccal Film [Belbuca]'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C4056633', 'cui_str': 'Buprenorphine Buccal Film [Belbuca]'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0282274', 'cui_str': 'Oxycodone hydrochloride'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}]","[{'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0004379', 'cui_str': 'Driving'}]",,0.319049,"CONCLUSIONS BBF did not significantly reduce respiratory drive at any dose compared with placebo, including at the maximum available prescription dose of 900 μg.","[{'ForeName': 'Lynn R', 'Initials': 'LR', 'LastName': 'Webster', 'Affiliation': 'PRA Health Sciences, Salt Lake City, UT, USA. WebsterLynn@prahs.com.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hansen', 'Affiliation': 'PRA Health Sciences, Salt Lake City, UT, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Cater', 'Affiliation': 'PRA Health Sciences, Salt Lake City, UT, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Smith', 'Affiliation': 'BioDelivery Sciences International, Inc., Raleigh, NC, USA.'}]",Advances in therapy,['10.1007/s12325-020-01481-0'] 1429,32980656,Effectiveness of the Super Skills for Life programme in enhancing the emotional wellbeing of children and adolescents in residential care institutions in a low- and middle-income country: A randomised waitlist-controlled trial.,"BACKGROUND The present study examined the effectiveness of a transdiagnostic prevention programme, Super Skills for Life (SSL), among children and adolescents with emotional problems in residential care institutions (RCIs) in the low- and middle-income country of Mauritius using a randomised waitlist-controlled trial (RCT). SSL is based on the principles of cognitive behavioural therapy, behavioural activation, social skills training, and uses video-feedback and cognitive preparation as part of the treatment. METHODS The RCT involved 100 children and adolescents aged 9 to 14 years, from six RCIs, randomly allocated to either an SSL intervention group (IG) or a waitlist-control (WLC) group. A set of questionnaires measuring internalising and externalising problems, emotion regulation and self-esteem, and experimental tasks measuring attentional bias and inhibitory control, were completed at baseline, post-intervention and 3-month follow-up. Participants also completed a 2-min video speech task during the first and final sessions of the SSL intervention. RESULTS Children and adolescents in the IG showed significant improvements in internalising symptoms (e.g. anxiety and depression), externalising symptoms (e.g. conduct problems and hyperactivity), and inhibitory control, and an increase in adaptive (except putting into perspective strategy) and decrease in maladaptive emotion regulation strategies, at both post-intervention and follow-up. These findings were not replicated among children in the WLC. LIMITATIONS The small sample size and lack of an active control group were the major limitations of this study. CONCLUSIONS This study provides evidence for the effectiveness of a transdiagnostic prevention programme for emotional problems in RCIs in a low- and middle-income country.",2021,"RESULTS Children and adolescents in the IG showed significant improvements in internalising symptoms (e.g. anxiety and depression), externalising symptoms (e.g. conduct problems and hyperactivity), and inhibitory control, and an increase in adaptive (except putting into perspective strategy) and decrease in maladaptive emotion regulation strategies, at both post-intervention and follow-up.","['children and adolescents with emotional problems in residential care institutions (RCIs) in the low- and middle-income country of Mauritius', 'children and adolescents in residential care institutions in a low- and middle-income country', 'emotional problems in RCIs in a low- and middle-income country', '100 children and adolescents aged 9 to 14 years, from six RCIs']","['transdiagnostic prevention programme', 'SSL intervention group (IG) or a waitlist-control (WLC', 'Super Skills for Life programme', 'transdiagnostic prevention programme, Super Skills for Life (SSL', 'SSL']","['emotional wellbeing', 'maladaptive emotion regulation strategies', 'internalising symptoms (e.g. anxiety and depression), externalising symptoms (e.g. conduct problems and hyperactivity), and inhibitory control', 'questionnaires measuring internalising and externalising problems, emotion regulation and self-esteem, and experimental tasks measuring attentional bias and inhibitory control']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0677660', 'cui_str': 'Emotional problems'}, {'cui': 'C0035186', 'cui_str': 'Residential Facilities'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0024944', 'cui_str': 'Mauritius'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}]",100.0,0.0681738,"RESULTS Children and adolescents in the IG showed significant improvements in internalising symptoms (e.g. anxiety and depression), externalising symptoms (e.g. conduct problems and hyperactivity), and inhibitory control, and an increase in adaptive (except putting into perspective strategy) and decrease in maladaptive emotion regulation strategies, at both post-intervention and follow-up.","[{'ForeName': 'Karishma', 'Initials': 'K', 'LastName': 'Ramdhonee-Dowlot', 'Affiliation': 'Department of Psychology, University of Roehampton, UK. Electronic address: ramdhonk@roehampton.ac.uk.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Balloo', 'Affiliation': 'University of Surrey, UK.'}, {'ForeName': 'Cecilia A', 'Initials': 'CA', 'LastName': 'Essau', 'Affiliation': 'Department of Psychology, University of Roehampton, UK.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.053'] 1430,32996017,Contextual Moderators of a School-Based Ethnic-Racial Identity Intervention: The Roles of Family Ethnic Socialization and Ethnic-Racial Background.,"Ethnic-racial identity (ERI) formation is a key developmental competency that contributes to adolescents' sense of self and psychosocial adjustment. A randomized controlled trial (RCT) has demonstrated the efficacy of a universal school-based health promotion intervention program to positively influence adolescents' ERI exploration and ERI resolution, compared to an attention control curriculum that was delivered by the same facilitators, had equivalent contact hours, and focused on post-secondary career and educational options. The current study extended prior tests of the RCT to better understand (a) how intervention-based ERI changes unfolded over two phases-temporally proximal pre- to post-test effects and long-term post-test effects across a 1-year follow-up period, and (b) identify for whom the intervention was more effective by testing theorized contextual moderators-baseline family ethnic socialization practices and youth ethnic-racial background (i.e., White majority vs. ethnic-racial minority). Bilinear spline growth models were used to examine longitudinal ERI trajectories in intervention and control groups across four survey assessments (baseline, 12 weeks, 18 weeks, 67 weeks; N = 215; M age  = 15.02; 49.1% female; 62.6% ethnic-racial minority). In support of an additive effect for the role of families in school-based interventions, post-test ERI exploration significantly increased (relative to the control group) to a greater extent for youth with higher (compared to lower) baseline levels of family ethnic socialization. ERI resolution significantly increased from pre- to post-test for ethnic-racial minority youth and also increased across the 1-year follow-up period for White youth in the intervention. These results highlight family ethnic socialization as a developmental asset for school-based ERI interventions and demonstrate differential pathways by which such interventions support ERI development for ethnic-racial minority and majority adolescents.",2021,ERI resolution significantly increased from pre- to post-test for ethnic-racial minority youth and also increased across the 1-year follow-up period for White youth in the intervention.,[],"['Contextual Moderators of a School-Based Ethnic-Racial Identity Intervention', 'universal school-based health promotion intervention program']",['ERI resolution'],[],"[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0424215', 'cui_str': 'Sense of identity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0424215', 'cui_str': 'Sense of identity'}]",,0.0203944,ERI resolution significantly increased from pre- to post-test for ethnic-racial minority youth and also increased across the 1-year follow-up period for White youth in the intervention.,"[{'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Sladek', 'Affiliation': 'Harvard Graduate School of Education, Cambridge, MA, 02138, USA. michael_sladek@gse.harvard.edu.'}, {'ForeName': 'Adriana J', 'Initials': 'AJ', 'LastName': 'Umaña-Taylor', 'Affiliation': 'Harvard Graduate School of Education, Cambridge, MA, 02138, USA.'}, {'ForeName': 'Kristia A', 'Initials': 'KA', 'LastName': 'Wantchekon', 'Affiliation': 'Harvard Graduate School of Education, Cambridge, MA, 02138, USA.'}, {'ForeName': 'Elana R', 'Initials': 'ER', 'LastName': 'McDermott', 'Affiliation': 'Harvard Graduate School of Education, Cambridge, MA, 02138, USA.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Updegraff', 'Affiliation': 'Arizona State University, Tempe, AZ, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01166-8'] 1431,33001241,Adjuvant hypofractionated radiotherapy with simultaneous integrated boost after breast-conserving surgery: results of a prospective trial.,"PURPOSE We report results of a multicenter prospective single-arm phase II trial (ARO-2013-04, NCT01948726) of moderately accelerated hypofractionated radiotherapy with a simultaneous integrated boost (SIB) in patients with breast cancer receiving adjuvant radiotherapy after breast-conserving surgery. METHODS The eligibility criteria included unifocal breast cancer with an indication for adjuvant radiotherapy to the whole breast and boost radiotherapy to the tumor bed. The whole breast received a dose of 40 Gy and the tumor bed a total dose of 48 Gy in 16 fractions of 2.5 and 3 Gy, respectively. Radiotherapy could be given either as 3D conformal RT (3D-CRT) or as intensity-modulated radiotherapy (IMRT). The study was designed as a prospective single-arm trial to evaluate the acute toxicity of the treatment regimen. The study hypothesis was that the frequency of acute skin reaction grade ≥2 would be 20% or less. RESULTS From November 2013 through July 2014, 149 patients were recruited from 12 participating centers. Six patients were excluded, leaving 143 patients for analysis. Eighty-four patients (58.7%) were treated with 3D-CRT and 59 (41.3%) with IMRT. Adherence to the treatment protocol was high. The rate of grade ≥2 skin toxicity was 14.7% (95% confidence interval 9.8-21.4%). The most frequent grade 3 toxicity (11%) was hot flashes. CONCLUSION This study demonstrated low toxicity of and high treatment adherence to hypofractionated adjuvant radiotherapy with SIB in a multicenter prospective trial, although the primary hypothesis was not met.",2021,The rate of grade ≥2 skin toxicity was 14.7% (95% confidence interval 9.8-21.4%).,"['Six patients were excluded, leaving 143\xa0patients for analysis', 'From November 2013 through July 2014, 149\xa0patients were recruited from 12\xa0participating centers', 'patients with breast cancer receiving adjuvant radiotherapy after breast-conserving surgery']","['moderately accelerated hypofractionated radiotherapy with a\xa0simultaneous integrated boost (SIB', 'hypofractionated adjuvant radiotherapy', 'adjuvant radiotherapy to the whole breast and boost radiotherapy', 'IMRT', 'Radiotherapy', '3D\xa0conformal RT (3D-CRT) or as intensity-modulated radiotherapy (IMRT', 'Adjuvant hypofractionated radiotherapy with simultaneous integrated boost after breast-conserving surgery']","['toxicity', 'acute toxicity', 'rate of grade ≥2 skin toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}, {'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C2919491', 'cui_str': 'Boost radiation therapy'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0026377', 'cui_str': 'Molecular conformation'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}]",6.0,0.0751359,The rate of grade ≥2 skin toxicity was 14.7% (95% confidence interval 9.8-21.4%).,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Krug', 'Affiliation': 'Klinik für Strahlentherapie, Universitätsklinikum Schleswig-Holstein, Arnold-Heller-Str.\xa03, 24105, Kiel, Germany. david.krug@uksh.de.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Baumann', 'Affiliation': 'Klinik für Strahlentherapie, Universitätsklinikum Schleswig-Holstein, Arnold-Heller-Str.\xa03, 24105, Kiel, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Krockenberger', 'Affiliation': 'ZKS Lübeck, Universität zu Lübeck, Lübeck, Germany.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Vonthein', 'Affiliation': 'Institut für Medizinische Biometrie und Statistik, Universität zu Lübeck, Lübeck, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schreiber', 'Affiliation': 'Praxis für Strahlentherapie Dr. med. Andreas Schreiber, Dresden, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Boicev', 'Affiliation': 'Klinik für Strahlentherapie und Radioonkologie, Heinrich-Braun-Klinikum Zwickau, Zwickau, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Würschmidt', 'Affiliation': 'Radiologische Allianz, Hamburg, Germany.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Weinstrauch', 'Affiliation': 'Praxis für Radioonkologie, Johanniter-Zentren für Medizinische Versorgung Stendal, Stendal, Germany.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Eilf', 'Affiliation': 'Praxis für Strahlentherapie, Kiel, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Andreas', 'Affiliation': 'Abteilung für Strahlentherapie, Krankenhaus Buchholz, Buchholz in der Nordheide, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Höller', 'Affiliation': 'MVZ Charité Vivantes, Berlin, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Dinges', 'Affiliation': 'Klinik für Strahlentherapie & Radioonkologie, Lüneburg, Germany.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Piefel', 'Affiliation': 'Strahlenzentrum Hamburg MVZ, Hamburg, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Zimmer', 'Affiliation': 'Praxis für Strahlentherapie Dr. med. Andreas Schreiber, Dresden, Germany.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Dellas', 'Affiliation': 'Klinik für Strahlentherapie, Universitätsklinikum Schleswig-Holstein, Arnold-Heller-Str.\xa03, 24105, Kiel, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Dunst', 'Affiliation': 'Klinik für Strahlentherapie, Universitätsklinikum Schleswig-Holstein, Arnold-Heller-Str.\xa03, 24105, Kiel, Germany.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-020-01689-7'] 1432,32975922,Subclinical hypothyroidism in pregnancy: controversies on diagnosis and treatment.,"The negative impact of even subtle maternal thyroid hormone deficiency on the pregnancy outcome and intellectual development of the progeny has been known for many years, but unfortunately the diagnosis and treatment of subclinical hypothyroidism in pregnant women still evokes controversies. Due to physiological changes in thyroid function and thyroid hormones metabolism during pregnancy, the trimester‑specific reference ranges for thyroid‑stimulating hormone (TSH) and free thyroid hormones should be established. However, because of interassay variability and other confounders including ethnicity and iodine intake, such norms are reliable only for local populations and a specific laboratory method. In turn, the fixed reference ranges suggested by endocrine societies may carry a risk of misclassificating some healthy pregnant women to be hypothyroid. The effect of levothyroxine treatment on pregnancy and children's cognitive outcomes remains unclear. Therapeutic benefits in decreasing miscarriage and preterm delivery rates were observed when intervention was held in the first trimester in women with a TSH level between 2.5 to 10 mU/l, mainly higher than or equal to 4 mU/l. The possible harmful effect of treatment includes preterm delivery, gestational diabetes, hypertension, and pre‑eclampsia. The only 3 prospective, randomized, placebo‑controlled trials evaluating the efficacy of levothyroxine therapy on children's intelligence quotient were started in the second trimester, which may be too late to demonstrate differences between treatment and placebo groups. Awaiting the results of future trials, clinicians should be aware of the fact that low‑dose levothyroxine at a daily dose of 25 to 50 µg is probably not harmful and may be beneficial, but the routine implementation of the therapy in each pregnant women with a TSH level exceeding 2.5 mU/l seems too premature.",2021,"Therapeutic benefits in decreasing miscarriage and preterm delivery rates were observed when intervention was held in the first trimester in women with TSH level 2.5-10 mU/l, mainly ≥4.0 mU/l.","['Subclinical hypothyroidism in pregnancy', 'pregnant women with TSH >2.5mU', 'healthy pregnant women']","['levothyroxine', 'levothyroxine therapy', 'placebo']","['preterm delivery, gestational diabetes, hypertension and pre-eclampsia', 'children intelligence quotient', 'miscarriage and preterm delivery rates']","[{'cui': 'C0271790', 'cui_str': 'Subclinical hypothyroidism'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}]","[{'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0456149', 'cui_str': 'Intelligence quotient'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}]",,0.104699,"Therapeutic benefits in decreasing miscarriage and preterm delivery rates were observed when intervention was held in the first trimester in women with TSH level 2.5-10 mU/l, mainly ≥4.0 mU/l.","[{'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Gietka-Czernel', 'Affiliation': 'Department of Endocrinology, Centre of Postgraduate Medical Education, Warsaw, Poland'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Glinicki', 'Affiliation': 'Department of Endocrinology, Centre of Postgraduate Medical Education, Warsaw, Poland. piotr.glinicki@bielanski.med.pl'}]",Polish archives of internal medicine,['10.20452/pamw.15626'] 1433,32972483,Tailoring cognitive behavioural therapy to subtypes of voice-hearing using a novel tabletised manual: a feasibility study.,"BACKGROUND Cognitive behavioural therapy for psychosis (CBTp) is a recommended treatment for psychotic experiences, but its effectiveness has been questioned. One way of addressing this may be to tailor therapy materials to the phenomenology of specific psychotic experiences. AIM In this study, we investigated the acceptability of a novel treatment manual for subtypes of 'voice-hearing' experiences (i.e. auditory verbal hallucinations). An uncontrolled, single-arm design was used to assess feasibility and acceptability of using the manual in routine care for people with frequent voice-hearing experiences. METHOD The manual was delivered on a smart tablet and incorporated recent research evidence and theory into its psychoeducation materials. In total, 24 participants completed a baseline assessment; 19 started treatment, 15 completed treatment and 12 participants completed a follow-up assessment (after 10 sessions of using the manual). RESULTS Satisfaction with therapy scores and acceptability ratings were high, while completion rates suggested that the manual may be more appropriate for help with participants from Early Intervention in Psychosis services rather than Community Mental Health Teams. CONCLUSION Within-group changes in symptom scores suggested that overall symptom severity of hallucinations - but not other psychosis features, or beliefs about voices - are likely to be the most appropriate primary outcome for further evaluation in a full randomised controlled trial.",2021,"An uncontrolled, single-arm design was used to assess feasibility and acceptability of using the manual in routine care for people with frequent voice-hearing experiences. ","[""subtypes of 'voice-hearing' experiences (i.e. auditory verbal hallucinations"", '24 participants completed a baseline assessment; 19 started treatment, 15 completed treatment and 12 participants completed a follow-up assessment (after 10 sessions of using the manual', 'psychosis (CBTp', 'people with frequent voice-hearing experiences']","['Cognitive behavioural therapy', 'Tailoring cognitive behavioural therapy']",['acceptability ratings'],"[{'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C2721589', 'cui_str': 'Verbal hallucinations'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C4273841', 'cui_str': 'Cognitive behavioral therapy for psychosis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",24.0,0.0520713,"An uncontrolled, single-arm design was used to assess feasibility and acceptability of using the manual in routine care for people with frequent voice-hearing experiences. ","[{'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Dodgson', 'Affiliation': 'Northumberland, Tyne & Wear NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Alderson-Day', 'Affiliation': 'Department of Psychology, Durham University, Durham, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Smailes', 'Affiliation': 'Department of Psychology, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Faye', 'Initials': 'F', 'LastName': 'Ryles', 'Affiliation': 'Northumberland, Tyne & Wear NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Mayer', 'Affiliation': 'Department of Psychology, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Glen-Davison', 'Affiliation': 'Department of Psychology, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Kaja', 'Initials': 'K', 'LastName': 'Mitrenga', 'Affiliation': 'Department of Psychology, Durham University, Durham, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Fernyhough', 'Affiliation': 'Department of Psychology, Durham University, Durham, UK.'}]",Behavioural and cognitive psychotherapy,['10.1017/S1352465820000661'] 1434,32976576,A randomized phase 2 trial of pomalidomide in subjects failing prior therapy for chronic graft-versus-host disease.,"Steroid-refractory chronic graft-versus-host disease (cGVHD) is a therapeutic challenge. Sclerotic skin manifestations are especially difficult to treat. We conducted a randomized phase 2 clinical trial (#NCT01688466) to determine the safety, efficacy, and preferred dose of pomalidomide in persons with moderate to severe cGVHD unresponsive to corticosteroids and/or subsequent lines of therapy. Thirty-four subjects were randomized to receive pomalidomide 0.5 mg per day orally (n = 17; low-dose cohort) or 2 mg per day at a starting dose of 0.5 mg per day increasing to 2 mg per day over 6 weeks (n = 17; high-dose cohort). The primary endpoint was overall response rate (ORR) at 6 months according to the 2005 National Institutes of Health cGVHD Response Criteria. Thirty-two patients had severe sclerotic skin and received a median of 5 (range, 2-10) previous systemic therapies. ORR was 47% (95% confidence interval, 30-65) in the intention-to-treat analyses. All were partial responses, with no difference in ORR between the cohorts. ORR was 67% (45%-84%) in the 24 evaluable subjects at 6 months. Nine had improvement in National Institutes of Health joint/fascia scores (P = .018). Median change from the baseline in body surface area involvement of skin cGVHD was -7.5% (-10% to 35%; P = .002). The most frequent adverse events were lymphopenia, infection, and fatigue. Eight subjects in the high-dose cohort had dose decreases because of adverse events. There was 1 death in the low-dose cohort from bacterial pneumonia. Our data indicate antifibrotic effects of pomalidomide and possible association with increases in concentrations of blood regulatory T-cell and interleukin-2. Pomalidomide 0.5 mg per day is a safe and effective therapy for advanced corticosteroid-refractory cGVHD.",2021,cGvHD was -7.5% (-10 to +35; p=0.002).,"['subjects failing prior therapy of chronic graft-versus-host disease', 'Thirty-four subjects', 'Thirty-two had severe sclerotic skin and received a median of 5 (range, 2-10) prior systemic therapies', 'persons with moderate to severe cGvHD unresponsive to corticosteroids and/or subsequent lines of therapy']","['Steroid-refractory chronic graft-versus-host disease (cGvHD', 'pomalidomide']","['NIH joint/fascia scores', 'lymphopenia, infection, and fatigue', 'overall response rate (ORR', 'ORR', 'body surface area (BSA) of involved skin', 'cGvHD']","[{'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0867389', 'cui_str': 'Chronic graft-versus-host disease'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0036429', 'cui_str': 'Sclerosis'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0867389', 'cui_str': 'Chronic graft-versus-host disease'}, {'cui': 'C2347624', 'cui_str': 'pomalidomide'}]","[{'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0867389', 'cui_str': 'Chronic graft-versus-host disease'}]",34.0,0.0923304,cGvHD was -7.5% (-10 to +35; p=0.002).,"[{'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Curtis', 'Affiliation': 'Immune Deficiency Cellular Therapy Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Alen', 'Initials': 'A', 'LastName': 'Ostojic', 'Affiliation': 'Immune Deficiency Cellular Therapy Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Venzon', 'Affiliation': 'Biostatistics and Data Management Section, National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Noa G', 'Initials': 'NG', 'LastName': 'Holtzman', 'Affiliation': 'Immune Deficiency Cellular Therapy Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Pirsl', 'Affiliation': 'Immune Deficiency Cellular Therapy Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Zoya J', 'Initials': 'ZJ', 'LastName': 'Kuzmina', 'Affiliation': 'Immune Deficiency Cellular Therapy Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Baird', 'Affiliation': 'Pediatric Oncology Branch and.'}, {'ForeName': 'Jeremy J', 'Initials': 'JJ', 'LastName': 'Rose', 'Affiliation': 'Experimental Transplantation and Immunology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Edward W', 'Initials': 'EW', 'LastName': 'Cowen', 'Affiliation': 'Dermatology Branch, National Institute for Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Jacqueline W', 'Initials': 'JW', 'LastName': 'Mays', 'Affiliation': 'Oral Immunobiology Unit, National Institute of Dental and Craniofacial Research, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Sandra A', 'Initials': 'SA', 'LastName': 'Mitchell', 'Affiliation': 'Outcomes Research Branch, Division of Cancer Control and Population Sciences, National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Parsons-Wandell', 'Affiliation': 'Immune Deficiency Cellular Therapy Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Galen O', 'Initials': 'GO', 'LastName': 'Joe', 'Affiliation': 'Department of Rehabilitation Medicine, and.'}, {'ForeName': 'Leora E', 'Initials': 'LE', 'LastName': 'Comis', 'Affiliation': 'Department of Rehabilitation Medicine, and.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Berger', 'Affiliation': 'Department of Pain and Palliative Care, Clinical Center, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Iskra', 'Initials': 'I', 'LastName': 'Pusic', 'Affiliation': 'Division of Oncology, Department of Medicine, Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'Cody J', 'Initials': 'CJ', 'LastName': 'Peer', 'Affiliation': 'Clinical Pharmacology Program and.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Figg', 'Affiliation': 'Clinical Pharmacology Program and.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'Genetics Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD; and.'}, {'ForeName': 'Robert Peter', 'Initials': 'RP', 'LastName': 'Gale', 'Affiliation': 'Centre for Haematology Research, Department of Immunology and Inflammation, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Frances T', 'Initials': 'FT', 'LastName': 'Hakim', 'Affiliation': 'Experimental Transplantation and Immunology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Steven Z', 'Initials': 'SZ', 'LastName': 'Pavletic', 'Affiliation': 'Immune Deficiency Cellular Therapy Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.'}]",Blood,['10.1182/blood.2020006892'] 1435,32979066,"Early clinical effects, safety, and appropriate selection of bone markers in romosozumab treatment for osteoporosis patients: a 6-month study.","Our 6-month study showed the usefulness of romosozumab for preventing fractures and its safety. It was effective in patients with low baseline spine BMD, high TRACP-5b, and high iP1NP. Percent change from baseline of TRACP-5b and iP1NP after 1 month correlated with that from baseline of BMD after four to 6-month treatment. INTRODUCTION Romosozumab appeared as a new osteoporosis medication in Japan in 2019. It is an anti-sclerostin antibody which increases bone formation and suppresses bone resorption. In this study, we analyzed the actual clinical effects, adverse effects, and the optimal way to evaluate the treatment. METHODS Romosozumab was administered as subcutaneous injection of 210 mg once every 4 weeks. We conducted pre-post study in 185 patients treated for 6 months. We focused on the incidence of new vertebral fractures, safety, bone mineral density (BMD) at the spine and total hip, and bone metabolism markers. We evaluated BMD before romosozumab treatment and after 4 to 6 months and performed the serum analysis before romosozumab treatment, after 1, 3, and 6 months. RESULTS There was no new fracture during treatment, and there was no fatal adverse event including cardiovascular disease. Since percent changes from baseline of the spine and total hip BMD were 6.34% and 1.53% after 4- to 6-month treatment, the treatment was effective for spine osteoporosis. Tartrate-resistant acid phosphatase 5b (TRACP-5b) and intact type I procollagen N-terminal propeptide (iP1NP) had significant changes during romosozumab treatment (p < 0.05). Percent change from baseline of TRACP-5b and iP1NP after 1 month correlated with percent change from baseline of BMD after 4 to 6 months of treatment. CONCLUSION Romosozumab is effective in preventing fractures and useful for increasing the spine BMD. Also, romosozumab is relatively safe to use. It is especially effective in patients with low baseline spine BMD, high TRACP-5b, and high iP1NP.",2021,I procollagen N-terminal propeptide (iP1NP) had significant changes during romosozumab treatment (p < 0.05).,"['185 patients treated for 6\xa0months', 'patients with low baseline spine BMD, high TRACP-5b, and high iP1NP', 'osteoporosis patients']","['Tartrate-resistant acid phosphatase 5b (TRACP-5b) and intact type', 'Romosozumab', 'romosozumab']","['TRACP-5b and iP1NP', 'spine and total hip BMD', 'fatal adverse event including cardiovascular disease', 'new vertebral fractures, safety, bone mineral density (BMD) at the spine and total hip, and bone metabolism markers', 'BMD', 'bone formation and suppresses bone resorption']","[{'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0297331', 'cui_str': 'Acid phosphatase bone isoenzyme'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}]","[{'cui': 'C0297331', 'cui_str': 'Acid phosphatase bone isoenzyme'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3661283', 'cui_str': 'romosozumab'}]","[{'cui': 'C0297331', 'cui_str': 'Acid phosphatase bone isoenzyme'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030786', 'cui_str': 'Hip Bone'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}]",185.0,0.0228051,I procollagen N-terminal propeptide (iP1NP) had significant changes during romosozumab treatment (p < 0.05).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tominaga', 'Affiliation': ""Department of Orthopedic Surgery, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Wada', 'Affiliation': ""Department of Orthopedic Surgery, Tokyo Women's Medical University, Tokyo, Japan. keijiwadajp@yahoo.co.jp.""}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Kato', 'Affiliation': 'Kita Shinagawa 3rd Hospital, Tokyo, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Nishi', 'Affiliation': 'Hasuda Hospital, Saitama, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Terayama', 'Affiliation': 'Hasuda Hospital, Saitama, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Okazaki', 'Affiliation': ""Department of Orthopedic Surgery, Tokyo Women's Medical University, Tokyo, Japan.""}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-020-05639-y'] 1436,32985080,"Predictors of receiving a diagnosis, referral and treatment of depression in people on antiretroviral therapy in South African primary care: a secondary analysis of data from a randomised trial.","OBJECTIVE To describe the receipt of a diagnosis, referral and treatment for depression in people receiving antiretroviral therapy (ART), with depressive symptoms and attending primary care clinics in South Africa, and investigate factors associated with receiving these components of care. METHODS This is a secondary analysis of data from a randomised controlled trial of an intervention intended to improve detection and treatment of depression in primary care patients receiving ART. In this analysis, we combined cross-sectional and longitudinal data from the intervention and control arms. Using regression models and adjusting for intra-cluster correlation of outcomes, we investigated associations between socioeconomic characteristics, depressive symptoms, stress, disability and stigma, and receipt of a diagnosis, referral and treatment for depression. RESULTS Of 2002 participants enrolled, 18% reported a previous diagnosis of depression by a healthcare worker and 10% reported having received counselling from a specialist mental health worker. Diagnosis, referral and counselling during the follow-up period were appropriately targeted, being independently more frequent in participants with higher enrolment scores for depressive symptoms, stress or disability. Participants with higher stigma scores at enrolment were independently less likely to receive counselling. Severe socio-economic deprivation was common but was not associated with treatment. CONCLUSION While the receipt of a diagnosis, referral and treatment for depression were uncommon, they seemed to be appropriately targeted. Socio-economic deprivation was not associated with treatment.",2020,Participants with higher stigma scores at enrolment were independently less likely to receive counselling.,"['people on antiretroviral therapy in South African primary care', '2002 participants enrolled, 18% reported a previous diagnosis of depression by a healthcare worker and 10% reported having received counselling from a specialist mental health worker', 'people receiving antiretroviral therapy (ART), with depressive symptoms and attending primary care clinics in South Africa', 'primary care patients receiving ART']",[],"['sociodemographic characteristics, depressive symptoms, stress, disability, and stigma, and receipt of a diagnosis, referral and treatment for depression', 'Socioeconomic deprivation', 'depressive symptoms, stress or disability', 'Severe socioeconomic deprivation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332132', 'cui_str': 'Prior diagnosis'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",2002.0,0.292692,Participants with higher stigma scores at enrolment were independently less likely to receive counselling.,"[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Zani', 'Affiliation': 'Knowledge Translation Unit, University of Cape Town Lung Institute, Cape Town, South Africa.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Fairall', 'Affiliation': 'Knowledge Translation Unit, University of Cape Town Lung Institute, Cape Town, South Africa.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Petersen', 'Affiliation': 'Centre for Rural Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Folb', 'Affiliation': 'Knowledge Translation Unit, University of Cape Town Lung Institute, Cape Town, South Africa.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bhana', 'Affiliation': 'Centre for Rural Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Thornicroft', 'Affiliation': ""Centre for Global Mental Health, King's College London, London, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hanass-Hancock', 'Affiliation': 'HIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lund', 'Affiliation': ""Centre for Global Mental Health, King's College London, London, UK.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bachmann', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13495'] 1437,32985089,Effect of continuous nursing based on wechat platform on postoperative rehabilitation of patients with lumbar disc herniation.,"OBJECTIVE The present randomized controlled trial was conducted to investigate the effect of continuous nursing based on wechat platform on postoperative rehabilitation of patients with lumbar disc herniation (LDH). METHODS A total of 95 patients with LDH who underwent surgery in Suzhou BenQ Medical Center from March 2, 2016 to June 23, 2018 were enrolled and randomly divided into the control group (routine continuous nursing) and the study group (continuous nursing based on wechat platform). During the follow-up, the patients' compliance and the effectiveness were recorded. The 36-Item Short-Form Health Survey scale (SF-36 score) was used to evaluate quality of life. The spinal nerve function was evaluated with Japanese Orthopedics Association (JOA) score while the lumbar function was determined with Oswestry dysfunction index (ODI). RESULTS There were 48 patients in the control group and 47 patients in the study group. The results showed that the compliance rate of the study group was 89.36%, significantly higher than that of the control group (60.42%). The effective rate of the study group was 95.74%, significantly higher than that of the control group (81.25%). Further, continuous nursing based on wechat platform brought more obvious improvement in the SF-36 scores as well as the JOA score and ODI. CONCLUSION The compliance rate and the effectiveness rate of patients received continuous nursing based on wechat platform were higher than those of patients who received routine continuous nursing, which further brought more obvious improvement in the quality of life as well as the JOA scores and ODI.",2021,"The effective rate of the study group was 95.74%, significantly higher than that of the control group (81.25%).","['95 patients with LDH who underwent surgery in Suzhou BenQ Medical Center from March 2, 2016 to June 23, 2018 were enrolled', 'patients with lumbar disc herniation', 'patients with lumbar disc herniation (LDH', '48 patients in the control group and 47 patients in the study group']","['continuous nursing based on wechat platform', 'control group (routine continuous nursing) and the study group (continuous nursing based on wechat platform']","['JOA score and ODI', 'compliance rate', '36-Item Short-Form Health Survey scale (SF-36 score', 'quality of life as well as the JOA scores and ODI', 'Japanese Orthopedics Association (JOA) score', 'Oswestry dysfunction index (ODI', 'compliance rate and the effectiveness rate', 'quality of life', 'spinal nerve function', 'SF-36 scores', 'effective rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0037941', 'cui_str': 'Spinal nerve structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",95.0,0.0184497,"The effective rate of the study group was 95.74%, significantly higher than that of the control group (81.25%).","[{'ForeName': 'Qiuxia', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': 'Department of Nursing, Suzhou BenQ Medical Center, The Affiliated BenQ Hospital of Nanjing Medical University, Suzhou, China.'}, {'ForeName': 'Jiehua', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Nursing, Suzhou BenQ Medical Center, The Affiliated BenQ Hospital of Nanjing Medical University, Suzhou, China.'}, {'ForeName': 'Maoping', 'Initials': 'M', 'LastName': 'Fan', 'Affiliation': 'Department of Nursing, Suzhou BenQ Medical Center, The Affiliated BenQ Hospital of Nanjing Medical University, Suzhou, China.'}, {'ForeName': 'Feifei', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Nursing, Suzhou BenQ Medical Center, The Affiliated BenQ Hospital of Nanjing Medical University, Suzhou, China.'}]",Japan journal of nursing science : JJNS,['10.1111/jjns.12382'] 1438,32990311,Associations Between Physical Therapy Visits and Pain and Physical Function After Knee Arthroplasty: A Cross-Lagged Panel Analysis of People Who Catastrophize About Pain Prior to Surgery.,"OBJECTIVE Physical therapy visit number and timing following knee arthroplasty (KA) are variable in daily practice. The extent to which the number and timing of physical therapy visits are associated with current and future pain and function-and, alternatively, whether pain and function are associated with the number of future physical therapy visits following KA-are unknown. The purpose of this study was to determine temporal and reciprocal associations between the number of physical therapy visits and future pain and function in people with KA. METHODS A cross-lagged panel design was applied to a secondary analysis of data from a randomized clinical trial of patients with pain catastrophizing. The 326 participants underwent KA and completed at least 7 of 9 health care diaries over the year following surgery. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and physical function subscales were completed preoperatively and multiple times during follow-up. Separate cross-lagged panel analyses were conducted for WOMAC pain and physical function. RESULTS From surgery to 2 months postsurgery, reciprocal associations were generally not found between physical therapy visit number and future pain or function. From 2 to 6 months postsurgery, a greater number of physical therapy weekly visits were associated with higher (worse) 6-month pain and function. Higher (worse) WOMAC pain at 2 and 6 months led to more visits from 2 to 6 and 6 to 12 months, respectively. CONCLUSIONS Higher pain scores 2 months postsurgery were associated with higher physical therapy use in the 2 to 6 months following surgery. However, patients with increased physical therapy use from 2 to 6 months had significantly higher pain scores 6 months postsurgery. Those patients with persistent pain 6 months postsurgery were higher users of physical therapy 6 to 12 months postsurgery. This reciprocal positive association between pain and physical therapy during this time period suggests minimal benefit of physical therapy despite an increased physical therapy use for patients with higher pain. IMPACT This is the first study to determine the association between the number and timing of physical therapy visits and current and future pain and function. Based on the results, physical therapy might not be a cost-effective strategy to treat patients with persistent pain following KA.",2021,"RESULTS From surgery to 2 months postsurgery, reciprocal associations were generally not found between physical therapy visit number and future pain or function.","['People', 'knee arthroplasty (KA', 'people with KA', 'patients with higher pain', 'patients with pain catastrophizing', 'After Knee Arthroplasty', 'patients with persistent pain following KA', '326 participants underwent KA and completed at least 7 of 9 health care diaries over the year following surgery']",[],"['Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and physical function subscales', 'WOMAC pain', 'physical therapy visit number and future pain or function', 'Pain and Physical Function', 'physical therapy utilization', 'number of physical therapy weekly visits', 'pain scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",[],"[{'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",326.0,0.0263247,"RESULTS From surgery to 2 months postsurgery, reciprocal associations were generally not found between physical therapy visit number and future pain or function.","[{'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Orndahl', 'Affiliation': 'Department of Biostatistics, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Perera', 'Affiliation': 'Department of Biostatistics, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Riddle', 'Affiliation': 'Departments of Physical Therapy, Orthopedic Surgery, and Rheumatology, Virginia Commonwealth University, Richmond, VA 23298-0224, USA.'}]",Physical therapy,['10.1093/ptj/pzaa182'] 1439,32988951,"Multicentre, single-blind randomised controlled trial comparing MyndMove neuromodulation therapy with conventional therapy in traumatic spinal cord injury: a protocol study.","INTRODUCTION This protocol is describing a multicentre, single-blind randomised controlled trial. The objective is to compare the efficacy of MyndMove therapy versus conventional therapy (CT) in improving upper extremity function in individuals with C4-C7 traumatic, incomplete spinal cord injury (SCI). It is being conducted in two US and two Canadian SCI rehabilitation centres. METHODS AND ANALYSIS Sixty people aged 18 years or older with a C4-C7 incomplete (AIS B-D) SCI between 4 months and 8 years postinjury are randomised to receive 40 sessions of MyndMove neuromodulation therapy or CT within a 14-week period of time. Therapy sessions are 1 hour in duration with a dose of 3-5 sessions per week. Assessments occur prior to randomisation, after 20 sessions, after 40 sessions and 10 weeks after the last session. The primary outcome measure is the efficacy of MyndMove therapy versus CT in improving upper extremity function as measured by Spinal Cord Independence Measure III: Self-Care subscore after 40 sessions. Secondary outcomes include: (1) improvements in the SCIM mobility subscore; (2) upper limb functions measured by Graded Redefined Assessment of Strength, Sensibility and Prehension and (3) Toronto Rehab Institute Hand Function Test; (4) To assess safety as measured by serious and non-serious adverse events recorded for participants in both groups of the study population over the duration of the study; (5) to compare the change in quality of life as measured by the Spinal Cord Injury-Quality of Life; and (6) to evaluate the impact on healthcare resource utilisation. ETHICS AND DISSEMINATION All ethical approvals were obtained prior to enrolling any participants. Dissemination of the results of the study will be made at peer-reviewed academic meetings and through peer-reviewed medical journals TRIAL REGISTRATION NUMBER: NCT03439319.",2020,"Secondary outcomes include: (1) improvements in the SCIM mobility subscore; (2) upper limb functions measured by Graded Redefined Assessment of Strength, Sensibility and Prehension and (3) Toronto Rehab Institute Hand Function Test; (4) To assess safety as measured by serious and non-serious adverse events recorded for participants in both groups of the study population over the duration of the study; (5) to compare the change in quality of life as measured by the Spinal Cord Injury-Quality of Life; and (6) to evaluate the impact on healthcare resource utilisation. ETHICS AND DISSEMINATION ","['Sixty people aged 18 years or older with a C4-C7 incomplete (AIS B-D) SCI between 4 months and 8 years postinjury', 'traumatic spinal cord injury', 'individuals with C4-C7 traumatic, incomplete spinal cord injury (SCI']","['MyndMove therapy versus conventional therapy (CT', 'MyndMove neuromodulation therapy or CT', 'conventional therapy', 'MyndMove neuromodulation therapy']","[' (1) improvements in the SCIM mobility subscore; (2) upper limb functions measured by Graded Redefined Assessment of Strength, Sensibility and Prehension and (3) Toronto Rehab Institute Hand Function Test; (4) To assess safety as measured by serious and non-serious adverse events', 'efficacy of MyndMove therapy versus CT in improving upper extremity function as measured by Spinal Cord Independence Measure III: Self-Care subscore', 'quality of life as measured by the Spinal Cord Injury-Quality of Life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0039585', 'cui_str': 'Androgen resistance syndrome'}, {'cui': 'C0763303', 'cui_str': ""N-bis(1-hydroxy-2-oxopropyl)-2'-deoxyguanosine""}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0394674', 'cui_str': 'Neurostimulation/modulation'}]","[{'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439823', 'cui_str': 'Sensibilities'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0037925', 'cui_str': 'Spinal cord structure'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}]",60.0,0.134899,"Secondary outcomes include: (1) improvements in the SCIM mobility subscore; (2) upper limb functions measured by Graded Redefined Assessment of Strength, Sensibility and Prehension and (3) Toronto Rehab Institute Hand Function Test; (4) To assess safety as measured by serious and non-serious adverse events recorded for participants in both groups of the study population over the duration of the study; (5) to compare the change in quality of life as measured by the Spinal Cord Injury-Quality of Life; and (6) to evaluate the impact on healthcare resource utilisation. ETHICS AND DISSEMINATION ","[{'ForeName': 'Kim D', 'Initials': 'KD', 'LastName': 'Anderson', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, MetroHealth System, Cleveland, Ohio, USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Wilson', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, MetroHealth System, Cleveland, Ohio, USA.'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Korupolu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Pierce', 'Affiliation': 'Centre for Neurology Studies, Health Tech Connex, Surrey, British Columbia, Canada.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Bowen', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Daria', 'Initials': 'D', 'LastName': ""O'Reilly"", 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Naaz', 'Initials': 'N', 'LastName': 'Kapadia', 'Affiliation': 'Toronto Rehabilitation Institute, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Milos R', 'Initials': 'MR', 'LastName': 'Popovic', 'Affiliation': 'The KITE Research Institute, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Kristin E', 'Initials': 'KE', 'LastName': 'Musselman', 'Affiliation': 'Toronto Rehabilitation Institute, University Health Network, Toronto, Ontario, Canada Kristin.Musselman@uhn.ca.'}]",BMJ open,['10.1136/bmjopen-2020-039650'] 1440,32992151,Cost and cost-effectiveness of interim methadone treatment and patient navigation initiated in jail.,"BACKGROUND Individuals with opioid use disorder (OUD) who are released from pre-trial detention in jail have a high risk of opioid relapse. While several interventions for OUD initiated during incarceration have been studied, few have had an economic evaluation. As part of a three-group randomized trial, we estimated the cost and cost-effectiveness of a negative urine opioid test. Detainees were assigned to interim methadone (IM) in jail with continued methadone treatment post-release with and without 3 months of post-release patient navigation (PN) compared to an enhanced treatment-as-usual group. METHODS We implemented a micro-costing approach from the provider's perspective to estimate the cost per participant in jail and over the 12 months post-release from jail. Economic data included jail-based and community-based service utilization, self-reported healthcare utilization and justice system involvement, and administrative arrest records. Our outcome measure is the number of participants with a negative opioid urine test at their 12-month follow-up. We calculated incremental cost-effectiveness ratios (ICERs) for intervention costs only and costs from a societal perspective. RESULTS The average cost of providing patient navigation services per individual beginning in jail and continuing in the community was $283. We find that IM is dominated by ETAU and IM + PN. Per additional participant with a negative opioid urine test, the ICER for IM + PN including intervention costs only is $91 and $305 including societal costs. CONCLUSIONS IM + PN is almost certainly the cost-effective choice from both an intervention provider and societal perspective.",2020,"Per additional participant with a negative opioid urine test, the ICER for IM + PN including intervention costs only is $91 and $305 including societal costs. ","['patient navigation initiated in jail', 'Individuals with opioid use disorder (OUD']","['interim methadone', 'methadone treatment post-release with and without 3 months of post-release patient navigation (PN) compared to an enhanced treatment-as-usual group', 'negative urine opioid test']","['incremental cost-effectiveness ratios (ICERs', 'average cost of providing patient navigation services', 'cost and cost-effectiveness', 'Cost and cost-effectiveness']","[{'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0392751', 'cui_str': 'In prison'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",,0.0840355,"Per additional participant with a negative opioid urine test, the ICER for IM + PN including intervention costs only is $91 and $305 including societal costs. ","[{'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Zarkin', 'Affiliation': 'RTI, International, 3040 East Cornwallis Road, PO Box 12194, Research Triangle Park, NC 27709-2194, United States.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Orme', 'Affiliation': 'RTI, International, 3040 East Cornwallis Road, PO Box 12194, Research Triangle Park, NC 27709-2194, United States. Electronic address: sorme@rti.org.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Dunlap', 'Affiliation': 'RTI, International, 3040 East Cornwallis Road, PO Box 12194, Research Triangle Park, NC 27709-2194, United States.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Kelly', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue Suite 103. Baltimore, MD 21201, United States.'}, {'ForeName': 'Shannon G', 'Initials': 'SG', 'LastName': 'Mitchell', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue Suite 103. Baltimore, MD 21201, United States.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': ""O'Grady"", 'Affiliation': 'Department of Psychology, University of Maryland, College Park, 4094 Campus Drive, College Park, MD 20742, United States.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Schwartz', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue Suite 103. Baltimore, MD 21201, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108292'] 1441,32993836,The effects of self-critical rumination on shame and stress: an experimental study.,"BACKGROUND Self-critical rumination is the process of repetitively thinking about one's past instances of failure without actively problem-solving. Shame has a central role within self-critical rumination and is accompanied by physiological changes that resemble stress responses. AIMS To experimentally investigate the effects of self-critical rumination on shame and stress following perceived failure. METHOD Sixty volunteers engaged in an impossible task that resulted in guaranteed failure. Four groups, combining presence or absence of induced self-critical rumination with high or low performance expectations, were created. Self-reports were used to measure levels of shame and stress at baseline immediately after the task, as well as following a debrief on the real purpose of the study. RESULTS Participants experiencing self-critical rumination accompanied by high performance expectations reported higher levels of shame and stress, especially immediately following the impossible task. On average, members of the high-expectations groups tended to score higher on shame and stress scales. Reported levels of trait self-critical rumination were also significantly correlated with levels of shame and stress across time when controlling for group membership and baseline stress and shame, respectively. CONCLUSIONS Self-critical rumination in highly evaluative circumstances increased levels of shame and stress following perceived failure. Even though highly evaluative conditions are considered a particularly strong predictor of shame and stress, they could potentially result in self-critical rumination; this matter needs to be addressed in future research.",2021,"On average, members of the high-expectations groups tended to score higher on shame and stress scales.",['Sixty volunteers engaged in an impossible task that resulted in guaranteed failure'],['self-critical rumination'],"['levels of trait self-critical rumination', 'shame and stress scales', 'shame and stress']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",60.0,0.0170865,"On average, members of the high-expectations groups tended to score higher on shame and stress scales.","[{'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Milia', 'Affiliation': 'Division of Psychology, School of Applied Sciences, London South Bank University, London, UK.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Kolubinski', 'Affiliation': 'Division of Psychology, School of Applied Sciences, London South Bank University, London, UK.'}, {'ForeName': 'Marcantonio M', 'Initials': 'MM', 'LastName': 'Spada', 'Affiliation': 'Division of Psychology, School of Applied Sciences, London South Bank University, London, UK.'}]",Behavioural and cognitive psychotherapy,['10.1017/S1352465820000727'] 1442,32998416,"Nutritional Intervention Reduces Dyslipidemia, Fasting Glucose and Blood Pressure in People Living with HIV/AIDS in Antiretroviral Therapy: A Randomized Clinical Trial Comparing Two Nutritional Interventions.","Antiretroviral therapy (ART) increases the risk of cardiometabolic diseases in people living with HIV/AIDS (PLWHA). However, there is a lack of evidence regarding the effectiveness of a nutritional intervention on several cardiometabolic parameters in this population. Therefore, this study aimed to evaluate the effectiveness of two nutritional interventions on several cardiometabolic parameters in PLWHA treated with ART. A parallel randomized clinical trial was performed with PLWHA treated with ART. The participants ( n = 88) were divided into two intervention groups: (1) nutritional counseling ( n = 44) and (2) individualized dietary prescription ( n = 44). The follow-up period was 30 weeks. A reduction in low-density lipoprotein (LDL) was the primary outcome. Secondary outcome variables were reductions in total cholesterol (TC), triglycerides (TG), fasting plasma glucose (FPG), systolic and diastolic blood pressures (SBP and DBP, respectively), waist circumference (WC), body mass index (BMI), and increases in high-density lipoproteins (HDL). A multiple linear regression was used to analyze the effectiveness of the interventions, adjusted for sociodemographic, lifestyle, and clinical characteristics. Sixty-two PLWHA completed the trial (nutritional counseling, n = 32; individualized dietary prescription, n = 30). At follow-up, we observed in the nutritional counseling group significant reductions in SBP ( p = 0.036) and DBP ( p = 0.001). Significant reductions in FPG ( p = 0.008) and DBP ( p = 0.023) were found in the individualized dietary prescription group. In the fully adjusted models, significant reductions in LDL, SBP, DBP, and BMI were found in the individualized dietary prescription group. In conclusion, the two investigated nutritional interventions were effective in reducing some cardiometabolic risk factors in PLWHA. However, after adjustments for covariates, the individualized dietary prescription showed significant reductions in the primary outcome and, also, in more cardiometabolic risk factors than the nutritional counseling.",2020,Significant reductions in FPG ( p = 0.008) and DBP ( p = 0.023) were found in the individualized dietary prescription group.,"['people living with HIV/AIDS (PLWHA', 'participants ( n = 88', 'People Living with HIV/AIDS in Antiretroviral Therapy']","['Nutritional Intervention', 'nutritional interventions', 'nutritional intervention', 'nutritional counseling ( n = 44) and (2) individualized dietary prescription', 'PLWHA treated with ART', 'Antiretroviral therapy (ART']","['Dyslipidemia, Fasting Glucose and Blood Pressure', 'total cholesterol (TC), triglycerides (TG), fasting plasma glucose (FPG), systolic and diastolic blood pressures (SBP and DBP, respectively), waist circumference (WC), body mass index (BMI), and increases in high-density lipoproteins (HDL', 'DBP', 'LDL, SBP, DBP, and BMI', 'low-density lipoprotein (LDL', 'cardiometabolic risk factors', 'several cardiometabolic parameters', 'FPG', 'SBP']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",88.0,0.0347523,Significant reductions in FPG ( p = 0.008) and DBP ( p = 0.023) were found in the individualized dietary prescription group.,"[{'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Aparecida Silveira', 'Affiliation': 'Department of Epidemiology & Public Health, Institute of Epidemiology & Health Care, University College London, London WC1E 6BT, UK.'}, {'ForeName': 'Marianne Oliveira', 'Initials': 'MO', 'LastName': 'Falco', 'Affiliation': 'Postgraduate Program in Health Sciences, Faculty of Medicine, Federal University of Goiás, Goiânia 74605-050, Brazil.'}, {'ForeName': 'Annelisa Silva E Alves de Carvalho', 'Initials': 'ASEAC', 'LastName': 'Santos', 'Affiliation': 'Postgraduate Program in Health Sciences, Faculty of Medicine, Federal University of Goiás, Goiânia 74605-050, Brazil.'}, {'ForeName': 'Matias', 'Initials': 'M', 'LastName': 'Noll', 'Affiliation': 'Department of Public Health, Instituto Federal Goiano, Ceres 76300-000, Brazil.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Epidemiology & Public Health, Institute of Epidemiology & Health Care, University College London, London WC1E 6BT, UK.'}]",Nutrients,['10.3390/nu12102970'] 1443,32998471,Lactobacillus reuteri DSM 17938 and Agave Inulin in Children with Cerebral Palsy and Chronic Constipation: A Double-Blind Randomized Placebo Controlled Clinical Trial.,"The main objective was to assess the efficacy of a probiotic ( Lactobacillus reuteri DSM 17938), a prebiotic (agave inulin), and a synbiotic on the stool characteristics in children with cerebral palsy and chronic constipation. Thirty-seven children with cerebral palsy and chronic constipation were included. The probiotic group received 1 × 10 8 colony forming unit (cfu) of L. reuteri DSM 17938 plus placebo, the prebiotic group received 4 g of agave inulin plus placebo, the synbiotic group received L. reuteri DSM 17938 plus agave inulin, and the placebo group received two placebos for 28 days. The probiotic group showed a significant decrease in stool pH ( p = 0.014). Stool consistency improved in the prebiotic group ( p = 0.008). The probiotic, prebiotic, and synbiotic groups showed a significant improvement in the history of excessive stool retention, the presence of fecal mass in the rectum, and the history of painful defecation. L. reuteri concentration in feces was higher in the probiotic group than in the placebo group ( p = 0.001) and showed an inverse correlation with stool pH in the probiotic group ( r = -0.762, p = 0.028). This study showed that the use of L. reuteri DSM 17938 and/or agave inulin improved the stool characteristics such as the history of painful defecation and the presence of fecal mass in the rectum against placebo in children with cerebral palsy and chronic constipation.",2020,"L. reuteri concentration in feces was higher in the probiotic group than in the placebo group ( p = 0.001) and showed an inverse correlation with stool pH in the probiotic group ( r = -0.762, p = 0.028).","['Children with Cerebral Palsy and Chronic Constipation', 'children with cerebral palsy and chronic constipation', 'Thirty-seven children with cerebral palsy and chronic constipation were included']","['probiotic ( Lactobacillus reuteri DSM 17938), a prebiotic (agave inulin), and a synbiotic', 'Lactobacillus reuteri DSM 17938 and Agave Inulin', 'placebo', 'DSM 17938 plus placebo, the prebiotic group received 4 g of agave inulin plus placebo, the synbiotic group received L. reuteri DSM 17938 plus agave inulin, and the placebo', 'Placebo', 'placebos']","['history of excessive stool retention, the presence of fecal mass', 'Stool consistency', 'stool pH', 'L. reuteri concentration in feces']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0401149', 'cui_str': 'Chronic constipation'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0331584', 'cui_str': 'Agave'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",37.0,0.16112,"L. reuteri concentration in feces was higher in the probiotic group than in the placebo group ( p = 0.001) and showed an inverse correlation with stool pH in the probiotic group ( r = -0.762, p = 0.028).","[{'ForeName': 'Andrea A', 'Initials': 'AA', 'LastName': 'García Contreras', 'Affiliation': 'Departamento de Nutrición y Bienestar Integral, Escuela de Medicina, Instituto Tecnológico y de Estudios Superiores Monterrey Campus Guadalajara, C.P. 4520 Zapopan, Jalisco, Mexico.'}, {'ForeName': 'Edgar M', 'Initials': 'EM', 'LastName': 'Vásquez Garibay', 'Affiliation': 'Departamento de Fisiología, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, C.P. 44340 Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Carmen A', 'Initials': 'CA', 'LastName': 'Sánchez Ramírez', 'Affiliation': 'Departamento de la Facultad de Medicina, Facultad de Medicina, Universidad de Colima, C.P. 28040 Colima, Colima, Mexico.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Fafutis Morris', 'Affiliation': 'Departamento de Fisiología, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, C.P. 44340 Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Vidal', 'Initials': 'V', 'LastName': 'Delgado Rizo', 'Affiliation': 'Departamento de Fisiología, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, C.P. 44340 Guadalajara, Jalisco, Mexico.'}]",Nutrients,['10.3390/nu12102971'] 1444,33009191,The synergistic effect of dexmedetomidine on propofol for paediatric deep sedation: A randomised trial.,"BACKGROUND Propofol and dexmedetomidine are used separately, and sometimes together, for paediatric deep sedation. Although their combination has been described in adults, the effect of dexmedetomidine as a potential synergist in children has not been studied before. OBJECTIVES The primary objective was to compare the propofol requirements of children who receive propofol alone with those who receive it in combination with dexmedetomidine for deep sedation for upper and lower endoscopic gastrointestinal procedures. DESIGN This was a prospective, open-label, randomised study comparing patients who received propofol alone (group P) with those who received dexmedetomidine and propofol (group DP). The depth of sedation was titrated to a target bispectral (BIS) index. SETTING A Gastroenterology Procedure Unit at a single, tertiary care academic medical centre from April 2018 until December 2019. PATIENTS Eligible patients were scheduled for upper endoscopy, lower endoscopy or both. A total of 39 patients were enrolled (20 DP) and (19 P). INTERVENTIONS Patients in Group DP received dexmedetomidine 0.5 μg kg-1 administered over 1 min followed by an infusion of 0.15 μg kg-1 h-1. In both groups, intravenous propofol was given in bolus increments titrated to a BIS index of 40 to 50 and then a continuous infusion of propofol to maintain BIS at 40 to 50. MAIN OUTCOME MEASURES The primary outcome measure was propofol requirement in each group. Secondary outcome measures were time to achieve the targeted sedation depth, time to achieve an Aldrete recovery score of 9, duration of sedation, mean BIS values, adverse events, 'PAED' scores and time to discharge from the postanaesthesia care unit (PACU). RESULTS The median (range) total dose of propofol was 0.23 (0.10 to 0.50) mg kg-1 min-1 in group DP and 0.40 (0.20 to 0.50) mg kg-1 min-1 in group P (P = 0.0004). Time of discharge from the PACU was 60 (20 to 121) min in group DP and 63 (46 to 91) min in group P (P = 0.0409). CONCLUSION The combination of dexmedetomidine and propofol for paediatric procedural sedation achieved a significant reduction in median propofol dose and a slightly shorter median time to discharge from PACU. Large-scale studies may determine whether this reduction decreases the risk of significant adverse events. TRIAL REGISTRATION ClinicalTrials.gov identifier NCT02952222.",2021,The combination of dexmedetomidine and propofol for paediatric procedural sedation achieved a significant reduction in median propofol dose and a slightly shorter median time to discharge from PACU.,"['A Gastroenterology Procedure Unit at a single, tertiary care academic medical centre from April 2018 until December 2019', 'group DP', 'paediatric deep sedation', 'group P) with those who received', 'children who receive propofol alone with those who receive it in combination with', '39 patients were enrolled (20 DP) and (19 P', 'for deep sedation for upper and lower endoscopic gastrointestinal procedures', 'Eligible patients were scheduled for upper endoscopy, lower endoscopy or both']","['dexmedetomidine and propofol', 'propofol', 'Propofol and dexmedetomidine', 'dexmedetomidine 0.5\u200aμg\u200akg administered over 1\u200amin followed by an infusion of 0.15\u200aμg\u200akg\u200ah', 'dexmedetomidine', 'propofol alone']","[""time to achieve the targeted sedation depth, time to achieve an Aldrete recovery score of 9, duration of sedation, mean BIS values, adverse events, 'PAED' scores and time to discharge from the postanaesthesia care unit (PACU"", 'propofol requirement', 'Time of discharge']","[{'cui': 'C0017163', 'cui_str': 'Gastroenterology'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1956064', 'cui_str': 'Sedation, Deep'}, {'cui': 'C0441849', 'cui_str': 'Group P'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0017195', 'cui_str': 'Endoscopy of stomach'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C4068886', 'cui_str': '0.15'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]",39.0,0.147768,The combination of dexmedetomidine and propofol for paediatric procedural sedation achieved a significant reduction in median propofol dose and a slightly shorter median time to discharge from PACU.,"[{'ForeName': 'Keira P', 'Initials': 'KP', 'LastName': 'Mason', 'Affiliation': ""From the Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital, Harvard Medical School, Boston (KPM, RSP, CAS), Special Care Nursery, Winchester Hospital,Winchester (EMH), Department of Experimental Therapeutics/Interventional Trials, Institutional Centers for Clinical and Translational Research, Boston Children's Hospital, Boston (STI), Boston Biostatistical Consulting, North Reading (DC), Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital (KL, RP) and Division of Gastroenterology, Hepatology & Nutrition, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, USA (VLF).""}, {'ForeName': 'Raymond Seungjoon', 'Initials': 'RS', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Cornelius A', 'Initials': 'CA', 'LastName': 'Sullivan', 'Affiliation': ''}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Lukovits', 'Affiliation': ''}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Halpin', 'Affiliation': ''}, {'ForeName': 'Samantha T', 'Initials': 'ST', 'LastName': 'Imbrescia', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cavanaugh', 'Affiliation': ''}, {'ForeName': 'Randy', 'Initials': 'R', 'LastName': 'Prescilla', 'Affiliation': ''}, {'ForeName': 'Victor L', 'Initials': 'VL', 'LastName': 'Fox', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001350'] 1445,32973117,Sentinel lymph node biopsy versus pelvic lymphadenectomy in early-stage cervical cancer: a multi-center randomized trial (PHENIX/CSEM 010).,"BACKGROUND There is no accepted strategy for applying sentinel lymph node (SLN) biopsy as an alternative to pelvic lymphadenectomy in cervical cancer. It is unclear whether and when pelvic lymphadenectomy can be safely replaced by SLN biopsy alone. PRIMARY OBJECTIVE To comprehensively compare the oncological outcomes of SLN biopsy with pelvic lymphadenectomy in patients with and without SLN metastasis. STUDY HYPOTHESIS It is hypothesized that the oncological outcomes provided by SLN biopsy are non-inferior to those of pelvic lymphadenectomy in patients with clinically early-stage cervical cancer if risk-adapted adjuvant treatments are given. TRIAL DESIGN All eligible patients will undergo SLN biopsy at the start of surgery. The resected SLNs will be submitted for frozen section examination. and patients will be triaged into the PHENIX-I (SLN-negative) or PHENIX-II (SLN-positive) cohort. In each cohort of this trial, patients will be randomized in a 1:1 ratio into the experimental (SLN biopsy alone) or reference (pelvic lymphadenectomy) arm. Radical hysterectomy will be performed for all patients, and adjuvant treatments will be planned according to post-operative pathological factors. MAJOR INCLUSION/EXCLUSION CRITERIA Patients aged between 18 and 65 years with histologically confirmed, untreated stage IA1 (lymphovascular space involvement), IA2, IB1, and IB2 cervical squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma. PRIMARY ENDPOINT The primary endpoint is disease-free survival. SAMPLE SIZE Estimated sample sizes of 830 and 250 are required to fulfill the study objectives of PHENIX-I and II, respectively. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS As of May 2020, more than 600 eligible patients have been enrolled. Enrollment is expected to be completed by December 2022, and presentation of results is expected in 2026. TRIAL REGISTRATION NCT02642471.",2020,"BACKGROUND There is no accepted strategy for applying sentinel lymph node (SLN) biopsy as an alternative to pelvic lymphadenectomy in cervical cancer.","['early-stage cervical cancer', 'patients with clinically early-stage cervical cancer', 'All eligible patients will undergo SLN biopsy at the start of surgery', '600 eligible patients have been enrolled', 'patients with and without SLN metastasis', 'Patients aged between 18 and 65 years with histologically confirmed, untreated stage IA1 (lymphovascular space involvement), IA2, IB1, and IB2 cervical squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma']","['pelvic lymphadenectomy', 'Radical hysterectomy', 'Sentinel lymph node biopsy versus pelvic lymphadenectomy', 'experimental (SLN biopsy alone) or reference (pelvic lymphadenectomy', 'SLN biopsy with pelvic lymphadenectomy']",['disease-free survival'],"[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0677944', 'cui_str': 'Sentinel node'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0458828', 'cui_str': 'Stage 1A1'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0206623', 'cui_str': 'Adenosquamous carcinoma'}]","[{'cui': 'C0193883', 'cui_str': 'Pelvic lymphadenectomy'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy'}, {'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",,0.17339,"BACKGROUND There is no accepted strategy for applying sentinel lymph node (SLN) biopsy as an alternative to pelvic lymphadenectomy in cervical cancer.","[{'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Tu', 'Affiliation': 'Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Bingna', 'Initials': 'B', 'LastName': 'Xian', 'Affiliation': 'Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Jibin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Clinical Trial Center, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Department of Gynecology, West China Second University Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Gynecologic Oncology, Anhui Provincial Cancer Hospital, Hefei, China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Gynecologic Oncology, Obstetrics & Gynecology Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': ""Department of Gynecologic Oncology, Women's Hospital of Zhejiang University, Hangzhou, China.""}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Gynecologic Oncology, Liaoning Cancer Hospital, Shenyang, China.'}, {'ForeName': 'Beihua', 'Initials': 'B', 'LastName': 'Kong', 'Affiliation': 'Department of Gynecology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': 'Department of Gynecology, Guangdong Province Traditional Chinese Medical Hospital, Guangzhou, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China liujih@mail.sysu.edu.cn.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001857'] 1446,32974672,In-vitro maturation of oocytes versus conventional IVF in women with infertility and a high antral follicle count: a randomized non-inferiority controlled trial.,"STUDY QUESTION Is one cycle of IVM non-inferior to one cycle of conventional in IVF with respect to live birth rates in women with high antral follicle counts (AFCs)? SUMMARY ANSWER We could not demonstrate non-inferiority of IVM compared with IVF. WHAT IS KNOWN ALREADY IVF with ovarian hyperstimulation has limitations in some subgroups of women at high risk of ovarian stimulation, such as those with polycystic ovary syndrome. IVM is an alternative ART for these women. IVM may be a feasible alternative to IVF in women with a high AFC, but there is a lack of data from randomized clinical trials comparing IVM with IVF in women at high risk of ovarian hyperstimulation syndrome. STUDY DESIGN, SIZE, DURATION This single-center, randomized, controlled non-inferiority trial was conducted at an academic infertility center in Vietnam from January 2018 to April 2019. PARTICIPANTS/MATERIALS, SETTING, METHODS In total, 546 women with an indication for ART and a high AFC (≥24 follicles in both ovaries) were randomized to the IVM (n = 273) group or the IVF (n = 273) group; each underwent one cycle of IVM with a prematuration step versus one cycle of IVF using a standard gonadotropin-releasing hormone antagonist protocol with gonadotropin-releasing hormone agonist triggering. The primary endpoint was live birth rate after the first embryo transfer. The non-inferiority margin for IVM versus IVF was -10%. MAIN RESULTS AND THE ROLE OF CHANCE Live birth after the first embryo transfer occurred in 96 women (35.2%) in the IVM group and 118 women (43.2%) in the IVF group (absolute risk difference -8.1%; 95% confidence interval (CI) -16.6%, 0.5%). Cumulative ongoing pregnancy rates at 12 months after randomization were 44.0% in the IVM group and 62.6% in the IVF group (absolute risk difference -18.7%; 95% CI -27.3%, -10.1%). Ovarian hyperstimulation syndrome did not occur in the IVM group, versus two cases in the IVF group. There were no statistically significant differences between the IVM and IVF groups with respect to the occurrence of pregnancy complications, obstetric and perinatal complications, preterm delivery, birth weight and neonatal complications. LIMITATIONS, REASONS FOR CAUTION The main limitation of the study was its open-label design. In addition, the findings are only applicable to IVM conducted using the prematuration step protocol used in this study. Finally, the single ethnicity population limits the external generalizability of the findings. WIDER IMPLICATIONS OF THE FINDINGS Our randomized clinical trial compares live birth rates after IVM and IVF. Although IVM is a viable and safe alternative to IVF that may be suitable for some women seeking a mild ART approach, the current study findings approach inferiority for IVM compared with IVF when cumulative outcomes are considered. Future research should incorporate multiple cycles of IVM in the study design to estimate cumulative fertility outcomes and better inform clinical decision-making. STUDY FUNDING/COMPETING INTEREST(S) This work was partly supported by Ferring grant number 000323 and funded by the Vietnam National Foundation for Science and Technology Development (NAFOSTED) and by the Fund for Research Flanders (FWO). LNV has received speaker and conference fees from Merck, grant, speaker and conference fees from Merck Sharpe and Dohme, and speaker, conference and scientific board fees from Ferring; TMH has received speaker fees from Merck, Merck Sharp and Dohme, and Ferring; RJN has received conference and scientific board fees from Ferring, is a minor shareholder in an IVF company, and receives grant funding from the National Health and Medical Research Council (NHMRC) of Australia; BWM has acted as a paid consultant to Merck, ObsEva and Guerbet, and is the recipient of grant money from an NHMRC Investigator Grant; RBG reports grants and fellowships from the NHMRC of Australia; JS reports lecture fees from Ferring Pharmaceuticals, Biomérieux, Besins Female Healthcare and Merck, grants from Fund for Research Flanders (FWO), and is co-inventor on granted patents on CAPA-IVM methodology in the US (US10392601B2) and Europe (EP3234112B1); TDP, VQD, VNAH, NHG, AHL, THP and RW have no financial relationships with any organizations that might have an interest in the submitted work in the previous three years, and no other relationships or activities that could appear to have influenced the submitted work. TRIAL REGISTRATION NUMBER NCT03405701 (www.clinicaltrials.gov). TRIAL REGISTRATION DATE 16 January 2018. DATE OF FIRST PATENT’S ENROLMENT 25 January 2018.",2020,"There were no statistically significant differences between the IVM and IVF groups with respect to the occurrence of pregnancy complications, obstetric and perinatal complications, preterm delivery, birth weight and neonatal complications. ","['16 January 2018', 'academic infertility center in Vietnam from January 2018 to April 2019', 'women with a high AFC', 'women with infertility and a high antral follicle count', 'women with high antral follicle counts (AFCs', '546 women with an indication for ART and a high AFC (≥24 follicles in both ovaries']","['conventional IVF', 'IVM and IVF', 'IVM with a prematuration step versus one cycle of IVF using a standard gonadotropin-releasing hormone antagonist protocol with gonadotropin-releasing hormone agonist triggering', 'IVF', 'IVM', 'IVF with ovarian hyperstimulation', 'LNV']","['live birth rate after the first embryo transfer', 'Cumulative ongoing pregnancy rates', 'Live birth', 'occurrence of pregnancy complications, obstetric and perinatal complications, preterm delivery, birth weight and neonatal complications', 'Ovarian hyperstimulation syndrome']","[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3273281', 'cui_str': 'Antral follicle count'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0227898', 'cui_str': 'Both ovaries'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0596795', 'cui_str': 'In Vivo Microscopy'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0549383', 'cui_str': 'Hyperstimulation of ovaries'}]","[{'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0032962', 'cui_str': 'Complication of pregnancy'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0085083', 'cui_str': 'Ovarian hyperstimulation syndrome'}]",546.0,0.265161,"There were no statistically significant differences between the IVM and IVF groups with respect to the occurrence of pregnancy complications, obstetric and perinatal complications, preterm delivery, birth weight and neonatal complications. ","[{'ForeName': 'Lan N', 'Initials': 'LN', 'LastName': 'Vuong', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Medicine and Pharmacy, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Vu N A', 'Initials': 'VNA', 'LastName': 'Ho', 'Affiliation': 'IVFMD, My Duc Hospital and HOPE Research Center, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Tuong M', 'Initials': 'TM', 'LastName': 'Ho', 'Affiliation': 'IVFMD, My Duc Hospital and HOPE Research Center, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Vinh Q', 'Initials': 'VQ', 'LastName': 'Dang', 'Affiliation': 'IVFMD, My Duc Hospital and HOPE Research Center, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Tuan H', 'Initials': 'TH', 'LastName': 'Phung', 'Affiliation': 'IVFMD, My Duc Hospital and HOPE Research Center, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nhu H', 'Initials': 'NH', 'LastName': 'Giang', 'Affiliation': 'IVFMD, My Duc Hospital and HOPE Research Center, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Anh H', 'Initials': 'AH', 'LastName': 'Le', 'Affiliation': 'IVFMD, My Duc Hospital and HOPE Research Center, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Toan D', 'Initials': 'TD', 'LastName': 'Pham', 'Affiliation': 'IVFMD, My Duc Hospital and HOPE Research Center, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynaecology, School of Clinical Sciences at Monash Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Smitz', 'Affiliation': 'Follicle Biology Laboratory, Free University of Brussels (VUB), Brussels, Belgium.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Gilchrist', 'Affiliation': ""School of Women's and Children's Health, University of New South Wales Sydney, New South Wales, Australia.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Norman', 'Affiliation': 'Robinson Research Institute and Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Ben W', 'Initials': 'BW', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, School of Clinical Sciences at Monash Health, Monash University, Melbourne, Victoria, Australia.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa240'] 1447,32974689,Combining high-intensity focused ultrasound (HIFU) ablation with percutaneous ethanol injection (PEI) in the treatment of benign thyroid nodules.,"OBJECTIVE Assessing the 6-month efficacy of combined high-intensity focused ultrasound (HIFU) ablation with percutaneous ethanol injection (PEI) in benign thyroid nodules by comparing it with HIFU ablation alone. METHODS One hundred and eighty-one (55.2%) patients underwent HIFU alone (group I) while 147 (44.8%) underwent concomitant HIFU and PEI treatment for solid or predominantly solid nodules (group II). Intravenous sedation and analgesia were given before the start of treatment. Extent of nodule shrinkage (by volume reduction ratio (VRR)), pain scores (by 0-10 visual analogue scale) during and after ablation, and rate of vocal cord palsy (VCP), skin burn, and nausea/vomiting were compared between the two groups. RESULTS The mean amount of ethanol injected in group II was 1.3 ± 0.7 ml. The 3- and 6-month VRR were significantly greater in group II (60.41 ± 20.49% vs. 50.13 ± 21.06%, p = 0.001; and 71.08 ± 21.25% vs. 61.37 ± 22.76%, p = 0.001, respectively), and ""on-beam"" treatment time was significantly shorter in group II (26.55 min vs. 30.26 min, p = 0.001). Group II patients reported significantly lower pain score during treatment (2.24 ± 3.07 vs. 4.97 ± 3.21, p < 0.001) and 2 h after treatment (2.23 ± 2.50 vs. 2.97 ± 4.39, p = 0.044). Rates of VCP, skin burn, and nausea or vomiting were not significantly different (p > 0.05). CONCLUSIONS The combined HIFU and PEI approach with improved administration of intravenous sedation and analgesia was associated with a significantly better 6-month efficacy than HIFU alone in benign thyroid nodules without compromising the safety and comfort of patients. KEY POINTS • Concomitant HIFU and PEI have a better treatment efficacy than HIFU alone. • Concomitant HIFU and PEI have a comparable safety profile as HIFU alone.",2021,"Rates of VCP, skin burn, and nausea or vomiting were not significantly different (p > 0.05). ","['benign thyroid nodules', 'One hundred and eighty-one (55.2']","['Combining high-intensity focused ultrasound (HIFU) ablation with percutaneous ethanol injection (PEI', 'combined high-intensity focused ultrasound (HIFU) ablation with percutaneous ethanol injection (PEI', 'concomitant HIFU and PEI treatment for solid or predominantly solid nodules', 'HIFU ablation alone', 'HIFU alone']","['on-beam"" treatment time', '3- and 6-month VRR', 'nodule shrinkage (by volume reduction ratio (VRR)), pain scores (by 0-10 visual analogue scale) during and after ablation, and rate of vocal cord palsy (VCP), skin burn, and nausea/vomiting', 'mean amount of ethanol', 'Rates of VCP, skin burn, and nausea or vomiting', 'pain score']","[{'cui': 'C0749467', 'cui_str': 'Benign thyroid nodule'}, {'cui': 'C4319557', 'cui_str': '180'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0441583', 'cui_str': 'High intensity focused ultrasound'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C4307245', 'cui_str': 'Ethanol Injection'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0028259', 'cui_str': 'Nodule'}, {'cui': 'C2348970', 'cui_str': 'High intensity focused ultrasound ablation'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0028259', 'cui_str': 'Nodule'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0042928', 'cui_str': 'Vocal cord paralysis'}, {'cui': 'C0565944', 'cui_str': 'Burn of skin of body region'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",,0.0356299,"Rates of VCP, skin burn, and nausea or vomiting were not significantly different (p > 0.05). ","[{'ForeName': 'Brian H H', 'Initials': 'BHH', 'LastName': 'Lang', 'Affiliation': 'Department of Surgery, The University of Hong Kong, Hong Kong SAR, China. blang@hku.hk.'}, {'ForeName': 'Yu-Cho', 'Initials': 'YC', 'LastName': 'Woo', 'Affiliation': 'Department of Medicine, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Keith Wan-Hang', 'Initials': 'KW', 'LastName': 'Chiu', 'Affiliation': 'Department of Radiology, The University of Hong Kong, Hong Kong SAR, China.'}]",European radiology,['10.1007/s00330-020-07317-3'] 1448,32978029,Static Ultrasound Guidance VS. Anatomical Landmarks for Subclavian Vein Puncture in the Intensive Care Unit: A Pilot Randomized Controlled Study.,"BACKGROUND Subclavian vein puncture is commonly used in the intensive care unit (ICU) but is associated with complications. OBJECTIVE Our aim was to compare the efficacy and safety of static ultrasound-guided subclavian vein puncture with traditional anatomical landmark-guided subclavian vein puncture in critically ill patients in the ICU. METHODS This pilot randomized controlled trial enrolled patients admitted to the ICU and requiring subclavian vein puncture between November 2017 and September 2018. The patients were randomized to ultrasound-guided puncture or anatomical landmark-guided puncture. The primary outcome measure was the puncture success rate. The secondary outcome measures included the number of punctures, rate of success at the first attempt, puncture time (i.e., procedure duration) and incidence of complications. RESULTS A total of 194 patients were included in the analyses. Compared with the anatomical landmarks group, the ultrasound group had a higher puncture success rate (91.7% vs. 77.6%; p = 0.007), lower rate of complications (7.3% vs. 20.4%; p = 0.008), and lower incidence of mispuncture of an artery (2.1% vs. 14.3%; p = 0.002). There were no significant differences in the number of punctures and puncture time between the two groups (both, p > 0.05). CONCLUSIONS Static ultrasound-guided subclavian vein puncture is superior to the traditional landmark-guided approach for critically ill patients in the ICU. It is suggested that static ultrasound-guided puncture techniques should be considered for subclavian vein puncture in the ICU. TRIAL REGISTRATION ChiCTR1900024051.",2020,"There were no significant differences in the number of punctures and puncture time between the two groups (both, p > 0.05). ","['A total of 194 patients were included in the analyses', 'enrolled patients admitted to the ICU and requiring subclavian vein puncture between November 2017 and September 2018', 'critically ill patients in the ICU', 'Intensive Care Unit']","['Static Ultrasound Guidance VS', 'Static ultrasound-guided subclavian vein puncture', 'static ultrasound-guided subclavian vein puncture with traditional anatomical landmark-guided subclavian vein puncture', 'ultrasound-guided puncture or anatomical landmark-guided puncture']","['efficacy and safety', 'puncture success rate', 'number of punctures, rate of success at the first attempt, puncture time (i.e., procedure duration) and incidence of complications', 'number of punctures and puncture time', 'rate of complications']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0038532', 'cui_str': 'Structure of subclavian vein'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}]","[{'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0038532', 'cui_str': 'Structure of subclavian vein'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",194.0,0.120026,"There were no significant differences in the number of punctures and puncture time between the two groups (both, p > 0.05). ","[{'ForeName': 'Qingyu', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Intensive Care Unit, Second Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang, China.'}, {'ForeName': 'Jiming', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': 'Department of Intensive Care Unit, Second Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang, China.'}, {'ForeName': 'Zhiwei', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': 'Department of Intensive Care Unit, Second Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang, China.'}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Department of Intensive Care Unit, Second Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang, China.'}, {'ForeName': 'Yufang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Intensive Care Unit, Second Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Department of Intensive Care Unit, Second Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang, China.'}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': 'Department of Intensive Care Unit, Second Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang, China.'}, {'ForeName': 'Shaoyi', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Department of Intensive Care Unit, Second Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang, China.'}]",The Journal of emergency medicine,['10.1016/j.jemermed.2020.07.039'] 1449,32979230,Two randomized controlled trials of the efficacy of acceptance and commitment therapy-based educational course for body shape dissatisfaction.,"The main aim of this project was to explore the efficacy of Acceptance and Commitment Therapy (ACT)-based educational course in different formats (i.e., pure and guided self-help with different durations, and guided self-help with and without access to a discussion forum) for body shape dissatisfaction. Two randomized controlled studies (RCT) were carried out. In the first RCT, the participants were randomized to a 12- or 16-week guided self-help, a 16-week pure self-help, or a waitlist control condition. In the second RCT, the efficacy of 12-week guided self-help with or without access to a discussion forum was investigated. ACT-based self-help resulted in promising improvements in body shape dissatisfaction, and modest effects on general health indicators (i.e., symptom of depression, self-esteem, satisfaction with life, and quality of life). The findings also showed no additional effects of support, access to the online discussion forum, and longer duration of self-help, suggesting the 12-week self-help with or without support is a viable option for reducing body shape dissatisfaction.",2021,"ACT-based self-help resulted in promising improvements in body shape dissatisfaction, and modest effects on general health indicators (i.e., symptom of depression, self-esteem, satisfaction with life, and quality of life).",[],['acceptance and commitment therapy-based educational course'],"['general health indicators (i.e., symptom of depression, self-esteem, satisfaction with life, and quality of life']",[],"[{'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0447353,"ACT-based self-help resulted in promising improvements in body shape dissatisfaction, and modest effects on general health indicators (i.e., symptom of depression, self-esteem, satisfaction with life, and quality of life).","[{'ForeName': 'Kerim', 'Initials': 'K', 'LastName': 'Selvi', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Parling', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Brjánn', 'Initials': 'B', 'LastName': 'Ljótsson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Welch', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ata', 'Initials': 'A', 'LastName': 'Ghaderi', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}]",Scandinavian journal of psychology,['10.1111/sjop.12684'] 1450,32981043,"A Randomized, Double-Dummy, Emergency Department-Based Study of Greater Occipital Nerve Block With Bupivacaine vs Intravenous Metoclopramide for Treatment of Migraine.","BACKGROUND Greater occipital nerve blocks (GONB) are used increasingly to treat acute migraine. OBJECTIVE We conducted a randomized controlled trial to determine whether GONB was as effective as intravenous metoclopramide for migraine. METHODS This was a double-dummy, double-blind, parallel-arm, non-inferiority study conducted in 2 emergency departments (EDs). Patients with migraine of moderate or severe intensity were randomized to receive bilateral GONB with each side administered 3 mL of bupivacaine 0.5% or metoclopramide 10 mg IV, the putative standard of care. The primary outcome was improvement in pain on a 0-10 scale between time 0 and 1 hour later. To reject the null hypothesis that metoclopramide would be more efficacious in relieving pain, we required that the lower limit of the 95% CI for the difference in pain improvement between those randomized to GONB vs those randomized to metoclopramide be >-1.3, a validated minimum clinically important difference. Secondary outcomes included sustained headache relief, defined as achieving and maintaining for 48 hours a headache level of mild or none without the use of additional analgesic medication, and the use of rescue medication in the ED. RESULTS Over a 2.5-year study period, 1358 patients were screened for participation and 99 were randomized, 51 to GONB and 48 to metoclopramide. All of these patients were included in the primary analysis. Patients who received the GONB reported mean improvement of 5.0 (95% CI: 4.1, 5.8) while those who received metoclopramide reported a larger mean improvement of 6.1 (95% CI: 5.2, 6.9). The 95% CI for the between group difference of -1.1 was -2.3, 0.1. Sustained headache relief was reported by 11/51 (22%) GONB and 18/47 (38%) metoclopramide patients (95% CI for rounded difference of 17%: -1, 35%). Of the 51 GONB patients, 17 (33%) required rescue medication in the ED vs 8/48 (17%) metoclopramide patients (95% CI for rounded difference of 17%: 0, 33%). An adverse event was reported by 16/51 (31%) GONB patients and 18/48 (38%) metoclopramide patients (95% CI for (rounded) difference of 6%: -13, 25%). CONCLUSION GONB with bupivacaine was not as efficacious as IV metoclopramide for the first-line treatment of migraine in the ED.",2020,"The 95% CI for the between group difference of -1.1 was -2.3, 0.1.","['Patients with migraine of moderate or severe intensity', '1358 patients were screened for participation and 99 were randomized, 51 to GONB and 48 to', '2 emergency departments (EDs']","['bupivacaine', 'GONB', 'Bupivacaine vs Intravenous Metoclopramide', 'metoclopramide', 'bilateral GONB with each side administered 3\xa0mL of bupivacaine 0.5% or metoclopramide']","['rescue medication', 'pain on a 0-10 scale between time 0 and 1\xa0hour later', 'sustained headache relief, defined as achieving and maintaining for 48\xa0hours a headache level of mild or none without the use of additional analgesic medication, and the use of rescue medication in the ED', 'adverse event', 'relieving pain', 'Sustained headache relief', 'pain improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0394692', 'cui_str': 'Injection of anesthetic agent into greater occipital nerve'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0394692', 'cui_str': 'Injection of anesthetic agent into greater occipital nerve'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",1358.0,0.637252,"The 95% CI for the between group difference of -1.1 was -2.3, 0.1.","[{'ForeName': 'Benjamin W', 'Initials': 'BW', 'LastName': 'Friedman', 'Affiliation': 'Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore, Bronx, NY, USA.'}, {'ForeName': 'Eddie', 'Initials': 'E', 'LastName': 'Irizarry', 'Affiliation': 'Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore, Bronx, NY, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Williams', 'Affiliation': 'Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore, Bronx, NY, USA.'}, {'ForeName': 'Clemencia', 'Initials': 'C', 'LastName': 'Solorzano', 'Affiliation': 'Pharmacy Department, Montefiore, Bronx, NY, USA.'}, {'ForeName': 'Eleftheria', 'Initials': 'E', 'LastName': 'Zias', 'Affiliation': 'Pharmacy Department, Montefiore, Bronx, NY, USA.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Robbins', 'Affiliation': 'Department of Neurology, Weill Cornell Medicine, New York-Presbyterian, New York, NY, USA.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Harrilal', 'Affiliation': 'Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore, Bronx, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Del Valle', 'Affiliation': 'Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore, Bronx, NY, USA.'}, {'ForeName': 'Polly E', 'Initials': 'PE', 'LastName': 'Bijur', 'Affiliation': 'Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore, Bronx, NY, USA.'}, {'ForeName': 'E John', 'Initials': 'EJ', 'LastName': 'Gallagher', 'Affiliation': 'Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore, Bronx, NY, USA.'}]",Headache,['10.1111/head.13961'] 1451,32981695,Long-term safety in patients with recurrent ovarian cancer treated with niraparib versus placebo: Results from the phase III ENGOT-OV16/NOVA trial.,"OBJECTIVE Niraparib is a poly(ADP-ribose) polymerase (PARP) inhibitor approved for use in heavily pretreated patients and as maintenance treatment in patients with newly-diagnosed or recurrent ovarian cancer following a response to platinum-based chemotherapy. We present long-term safety data for niraparib from the ENGOT-OV16/NOVA trial. METHODS This multicenter, double-blind, randomized, controlled phase III trial evaluated the efficacy and safety of niraparib for the treatment of recurrent ovarian cancer. Patients were randomly assigned 2:1 to receive either once-daily niraparib 300 mg or placebo. Two independent cohorts were enrolled based on germline BRCA mutation status. The primary endpoint was progression-free survival, reported previously. Long-term safety data were from the most recent data cutoff (September 2017). RESULTS Overall, 367 patients received niraparib 300 mg once daily. Dose reductions due to TEAEs were highest in month 1 (34%) and declined every month thereafter. Incidence of any-grade and grade ≥ 3 hematologic and symptomatic TEAEs was also highest in month 1 and subsequently declined. Incidence of grade ≥ 3 thrombocytopenia decreased from 28% (month 1) to 9% and 5% (months 2 and 3, respectively), with protocol-directed dose interruptions and/or reductions. Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) were reported in 2 and 6 niraparib-treated patients, respectively, and in 1 placebo patient each. Treatment discontinuations due to TEAEs were <5% in each month and time interval measured. CONCLUSION These data demonstrate the importance of appropriate dose reduction according to toxicity criteria and support the safe long-term use of niraparib for maintenance treatment in patients with recurrent ovarian cancer. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT01847274.",2020,Incidence of any-grade and grade ≥ 3 hematologic and symptomatic TEAEs was also highest in month 1 and subsequently declined.,"['recurrent ovarian cancer', 'patients with recurrent ovarian cancer', 'patients with newly-diagnosed or recurrent ovarian cancer', '367 patients received', 'patients with recurrent ovarian cancer treated with']","['niraparib 300\xa0mg once daily', 'niraparib', 'niraparib versus placebo', 'once-daily niraparib 300\xa0mg or placebo', 'platinum-based chemotherapy']","['3 thrombocytopenia', 'efficacy and safety', 'Incidence of grade\xa0≥', 'Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS', 'progression-free survival', 'Incidence of any-grade and grade\xa0≥\xa03 hematologic and symptomatic TEAEs']","[{'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C2744440', 'cui_str': 'niraparib'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C2347761', 'cui_str': 'Childhood myelodysplastic syndrome'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]",,0.360978,Incidence of any-grade and grade ≥ 3 hematologic and symptomatic TEAEs was also highest in month 1 and subsequently declined.,"[{'ForeName': 'Mansoor R', 'Initials': 'MR', 'LastName': 'Mirza', 'Affiliation': 'Nordic Society of Gynaecological Oncology Clinical Trial Unit (NSGO-CTU), Rigshospitalet-Copenhagen University Hospital, Copenhagen, Denmark. Electronic address: mansoor@rh.regionh.dk.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Benigno', 'Affiliation': 'Northside Hospital, Atlanta, GA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dørum', 'Affiliation': 'Radiumhospitalet, Oslo University Hospital, NSGO, Oslo, Norway.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mahner', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital, LMU Munich, AGO, Munich, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bessette', 'Affiliation': 'Sherbrooke University, Sherbrooke, QC, Canada.'}, {'ForeName': 'I Bover', 'Initials': 'IB', 'LastName': 'Barceló', 'Affiliation': 'Hospital Son Llàtzer, GEICO, Palma de Mallorca, Spain.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Berton-Rigaud', 'Affiliation': ""Institut de Cancérologie de l'Ouest Centre René Gauducheau, GINECO, Saint-Herblain, France.""}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Ledermann', 'Affiliation': 'UCL Cancer Institute, University College London, NCRI, London, UK.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Rimel', 'Affiliation': 'Cedars-Sinai Medical Center, West Hollywood, CA, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Herrstedt', 'Affiliation': 'Odense University Hospital, Odense, Denmark; Zealand University Hospital, NSGO, Roskilde, Denmark.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lau', 'Affiliation': 'McGill University, Montreal, QC, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'du Bois', 'Affiliation': 'Kliniken Essen Mitte, AGO, Essen, Germany.'}, {'ForeName': 'A Casado', 'Initials': 'AC', 'LastName': 'Herráez', 'Affiliation': 'Hospital Clínico San Carlos, GEICO, Madrid, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kalbacher', 'Affiliation': 'Centre Hospitalier Régional et Universitaire de Besançon, GINECO, Besançon, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Buscema', 'Affiliation': 'Arizona Oncology Associates, Tucson, AZ, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lorusso', 'Affiliation': 'Fondazione Policlinico Universitario a Gemelli IRCCS, Istituto Nazionale dei Tumori, MITO, Milan, Italy.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Vergote', 'Affiliation': 'University of Leuven, Leuven Cancer Institute, BGOG, Leuven, Belgium.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Levy', 'Affiliation': 'Wolfson Medical Center, ISGO, Holon, Israel.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'GlaxoSmithKline, Waltham, MA, USA.'}, {'ForeName': 'F A', 'Initials': 'FA', 'LastName': 'de Jong', 'Affiliation': 'GlaxoSmithKline, Zug, Switzerland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Gupta', 'Affiliation': 'GlaxoSmithKline, Waltham, MA, USA.'}, {'ForeName': 'U A', 'Initials': 'UA', 'LastName': 'Matulonis', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.09.006'] 1452,32990630,"Promoting Safe Injection Practices, Substance Use Reduction, Hepatitis C Testing, and Overdose Prevention Among Syringe Service Program Clients Using a Computer-Tailored Intervention: Pilot Randomized Controlled Trial.","BACKGROUND Syringe service programs (SSPs) are safe, highly effective programs for promoting health among people who inject drugs. However, resource limitations prevent the delivery of a full package of prevention services to many clients in need. Computer-tailored interventions may represent a promising approach for providing prevention information to people who inject drugs in resource-constrained settings. OBJECTIVE The aim of this paper is to assess the effect of a computer-tailored behavioral intervention, called Hep-Net, on safe injection practices, substance use reduction, overdose prevention, and hepatitis C virus (HCV) testing among SSP clients. METHODS Using a social network-based recruitment strategy, we recruited clients of an established SSP in Wisconsin and peers from their social networks. Participants completed a computerized baseline survey and were then randomly assigned to receive the Hep-Net intervention. Components of the intervention included an overall risk synthesis, participants' selection of a behavioral goal, and an individualized risk reduction exercise. Individuals were followed up 3 months later to assess their behavior change. The effect of Hep-Net on receiving an HCV screening test, undergoing Narcan training, reducing the frequency of drug use, and sharing drug equipment was assessed. The individual's readiness to change each behavior was also examined. RESULTS From 2014 to 2015, a total of 235 people who injected drugs enrolled into the Hep-Net study. Of these, 64.3% (151/235) completed the follow-up survey 3-6 months postenrollment. Compared with the control group, individuals who received the Hep-Net intervention were more likely to undergo HCV testing (odds ratio [OR] 2.23, 95% CI 1.05-4.74; P=.04) and receive Narcan training (OR 2.25, 95% CI 0.83-6.06; P=.11), and they shared drug equipment less frequently (OR 0.06, 95% CI 0.55-0.65; P<.001). Similarly, individuals who received the intervention were more likely to advance in their stage of readiness to change these 3 behaviors. However, intervention participants did not appear to reduce the frequency of drug use or increase their readiness to reduce drug use more than control participants, despite the fact that the majority of the intervention participants selected this as the primary goal to focus on after participation in the baseline survey. CONCLUSIONS Implementing computer-based risk reduction interventions in SSPs may reduce harms associated with the sharing of injection equipment and prevent overdose deaths; however, brief computerized interventions may not be robust enough to overcome the challenges associated with reducing and ceasing drug use when implemented in settings centered on the delivery of prevention services. TRIAL REGISTRATION ClinicalTrials.gov NCT02474043; https://clinicaltrials.gov/ct2/show/NCT02474043. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) RR1-10.2196/resprot.4830.",2020,"Computer-tailored interventions may represent a promising approach for providing prevention information to people who inject drugs in resource-constrained settings. ","['people who inject drugs', 'recruited clients of an established SSP in Wisconsin and peers from their social networks', 'SSP clients', 'From 2014 to 2015, a total of 235 people who injected drugs enrolled into the Hep-Net study']","['Hep-Net intervention', 'computer-tailored behavioral intervention', 'Hep-Net']","['overdose deaths', 'frequency of drug use, and sharing drug equipment', ""overall risk synthesis, participants' selection of a behavioral goal, and an individualized risk reduction exercise""]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C1857069', 'cui_str': 'Schöpf-Schulz-Passarge syndrome'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0162569', 'cui_str': 'Homozygous porphyria cutanea tarda'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0162569', 'cui_str': 'Homozygous porphyria cutanea tarda'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",235.0,0.0773248,"Computer-tailored interventions may represent a promising approach for providing prevention information to people who inject drugs in resource-constrained settings. ","[{'ForeName': 'Karli R', 'Initials': 'KR', 'LastName': 'Hochstatter', 'Affiliation': 'Columbia University School of Social Work, New York, NY, United States.'}, {'ForeName': 'Shawnika J', 'Initials': 'SJ', 'LastName': 'Hull', 'Affiliation': 'Department of Prevention and Community Health, Milken Institute School of Public Health, The George Washington University, Washington DC, DC, United States.'}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Sethi', 'Affiliation': 'Department of Population Health Sciences, University of Wisconsin School of Medicine and Public Health, Madison, WI, United States.'}, {'ForeName': 'Marguerite E', 'Initials': 'ME', 'LastName': 'Burns', 'Affiliation': 'Department of Population Health Sciences, University of Wisconsin School of Medicine and Public Health, Madison, WI, United States.'}, {'ForeName': 'Marlon P', 'Initials': 'MP', 'LastName': 'Mundt', 'Affiliation': 'Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, United States.'}, {'ForeName': 'Ryan P', 'Initials': 'RP', 'LastName': 'Westergaard', 'Affiliation': 'Department of Population Health Sciences, University of Wisconsin School of Medicine and Public Health, Madison, WI, United States.'}]",Journal of medical Internet research,['10.2196/19703'] 1453,32989170,Hormonal contraception and risk of STIs and bacterial vaginosis in South African adolescents: secondary analysis of a randomised trial.,"OBJECTIVES Young women in sub-Saharan Africa are at high risk of STIs and unintended pregnancies, yet hormonal contraceptive (HC) use may affect STI risk. We compared the influence of three HCs on the incidence and prevalence of STIs and bacterial vaginosis (BV) in South African adolescents. METHODS One hundred and thirty adolescents between 15 and 19 years were randomised to the injectable norethisterone enanthate (Net-En), combined oral contraceptives (COC) (Triphasil or Nordette) or a combined contraceptive vaginal ring (CCVR; NuvaRing) for 16 weeks (clinicaltrials.gov/NCT02404038). Vaginal samples were collected at baseline and 16 weeks post contraceptive initiation for STI and BV testing. RESULTS In an intention-to-treat analysis, no significant differences in BV prevalence were found between study arms. The overall incidence of any STI at follow-up was high: 16.2% in the COC arm; 25.7% in the Net-En arm; and 37.1% in the CCVR arm. The incidence rate (IR) of any STI was similar between Net-En (IR 0.74 (95% CI 0.34 to 1.41)) and the oestrogen-containing contraceptives (IR 0.78 (95% CI 0.47 to 1.22)). A lower IR of Chlamydia trachomatis (incidence rate ratio (IRR) 0.68 (95% CI 0.19 to 1.99)) and Neisseria gonorrhoeae (IRR 0.25 (95% CI 0.01 to 1.35)) but a higher IR of Mycoplasma genitalium (IRR 16.0 (95% CI 2.96 to 400)), was observed in the Net-En arm compared with the oestrogen-containing contraceptives, although the overall incidence of M. genitalium was low (4.7%). In an exploratory analysis, the risk of any STI and N. gonorrhoeae was lower in the COC arm compared with CCVR. A per-protocol analysis yielded similar results. CONCLUSION Our results suggest that use of Net-En may be associated with increased risk of M. genitalium compared with oestrogen-containing contraceptives but not with overall STI risk. COC use may decrease STI risk relative to CCVR.",2021,A lower IR of Chlamydia trachomatis (incidence rate ratio (IRR) 0.68,"['One hundred and thirty adolescents between 15 and 19 years', 'South African adolescents', 'Young women in sub-Saharan Africa']","['COC', 'injectable norethisterone enanthate (Net-En), combined oral contraceptives (COC) (Triphasil or Nordette) or a combined contraceptive vaginal ring (CCVR; NuvaRing']","['overall incidence of M. genitalium', 'risk of M. genitalium', 'higher IR of Mycoplasma genitalium', 'Hormonal contraception and risk of STIs and bacterial vaginosis', 'Neisseria gonorrhoeae', 'BV prevalence', 'incidence and prevalence of STIs and bacterial vaginosis (BV', 'overall incidence of any STI', 'risk of any STI and N. gonorrhoeae', 'IR of Chlamydia trachomatis (incidence rate ratio (IRR) 0.68', 'incidence rate (IR) of any STI']","[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}]","[{'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0068981', 'cui_str': 'Norethindrone enanthate'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0009906', 'cui_str': 'Oral Contraceptives, Combined'}, {'cui': 'C0728965', 'cui_str': 'Triphasil'}, {'cui': 'C0733743', 'cui_str': 'Nordette'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0317872', 'cui_str': 'Mycoplasma genitalium'}, {'cui': 'C2985296', 'cui_str': 'Hormonal contraception'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0027573', 'cui_str': 'Neisseria gonorrhoeae'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0008151', 'cui_str': 'Chlamydia trachomatis'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4517473', 'cui_str': '0.68'}]",130.0,0.267558,A lower IR of Chlamydia trachomatis (incidence rate ratio (IRR) 0.68,"[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Balle', 'Affiliation': 'Department of Pathology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, Western Cape, South Africa.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Gill', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, Western Cape, South Africa.'}, {'ForeName': 'Iyaloo N', 'Initials': 'IN', 'LastName': 'Konstantinus', 'Affiliation': 'Department of Pathology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, Western Cape, South Africa.'}, {'ForeName': 'Shameem Z', 'Initials': 'SZ', 'LastName': 'Jaumdally', 'Affiliation': 'Department of Pathology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, Western Cape, South Africa.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Lennard', 'Affiliation': 'Department of Integrative Biomedical Sciences, University of Cape Town, Cape Town, Western Cape, South Africa.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Esra', 'Affiliation': 'Department of Pathology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, Western Cape, South Africa.'}, {'ForeName': 'Anna-Ursula', 'Initials': 'AU', 'LastName': 'Happel', 'Affiliation': 'Department of Pathology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, Western Cape, South Africa.'}, {'ForeName': 'Shaun L', 'Initials': 'SL', 'LastName': 'Barnabas', 'Affiliation': 'Department of Pathology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, Western Cape, South Africa.'}, {'ForeName': 'Hoyam', 'Initials': 'H', 'LastName': 'Gamieldien', 'Affiliation': 'Department of Pathology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, Western Cape, South Africa.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Pidwell', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, Western Cape, South Africa.'}, {'ForeName': 'Venessa', 'Initials': 'V', 'LastName': 'Maseko', 'Affiliation': 'National Institute for Communicable Diseases, Johannesburg, Gauteng, South Africa.'}, {'ForeName': 'Maia', 'Initials': 'M', 'LastName': 'Lesosky', 'Affiliation': 'Division of Epidemiology, Biostatistics, School of Public Health & Family Medicine, University of Cape Town, Cape Town, Western Cape, South Africa.'}, {'ForeName': 'Landon', 'Initials': 'L', 'LastName': 'Myer', 'Affiliation': 'Division of Epidemiology, Biostatistics, School of Public Health & Family Medicine, University of Cape Town, Cape Town, Western Cape, South Africa.'}, {'ForeName': 'Jo-Ann S', 'Initials': 'JS', 'LastName': 'Passmore', 'Affiliation': 'Department of Pathology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, Western Cape, South Africa.'}, {'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, Western Cape, South Africa.'}, {'ForeName': 'Heather B', 'Initials': 'HB', 'LastName': 'Jaspan', 'Affiliation': 'Department of Pathology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, Western Cape, South Africa hbjaspan@gmail.com.'}]",Sexually transmitted infections,['10.1136/sextrans-2020-054483'] 1454,33237534,Pharmacokinetics and Safety of INL-001 (Bupivacaine HCl) Implants Compared with Bupivacaine HCl Infiltration After Open Unilateral Inguinal Hernioplasty.,"INTRODUCTION Surgical site infiltration with bupivacaine HCl results in short-lived analgesia for postsurgical pain and carries the risk of systemic bupivacaine toxicity due to accidental intravascular injection. INL-001 is a bupivacaine HCl collagen-matrix implant that provides extended delivery of bupivacaine directly at the site and avoids the risk of accidental injection. Here, we examine the pharmacokinetic (PK) and safety profile of INL-001 placement during unilateral open inguinal hernioplasty. METHODS This multicenter, single-blind study (NCT03234374) enrolled patients undergoing open inguinal hernioplasty to receive three INL-001 implants, each containing 100 mg bupivacaine HCl (n = 34) or local infiltration of 0.25% bupivacaine HCl 175 mg (n = 16). Acetaminophen was provided in the postsurgical period and supplemented by opioids for breakthrough pain, as needed. PK blood samples were taken before surgery and up to 96 h after drug administration. RESULTS INL-001 demonstrated a prolonged rate of absorption and clearance of bupivacaine compared with 0.25% bupivacaine HCl 175 mg, as demonstrated by a longer time to peak plasma concentration and terminal elimination half-life. Peak plasma concentration with INL-001 300 mg was comparable to bupivacaine HCl 175 mg and well below levels associated with systemic bupivacaine toxicity. The most common adverse events (AEs) in both groups were associated with general anesthesia and the postsurgical setting. No AE was related to the implant, including those associated with wound healing. CONCLUSIONS These findings demonstrate that INL-001 provides immediate and extended delivery of bupivacaine and is well tolerated in patients undergoing open inguinal hernioplasty with no adverse effect on wound healing. TRIAL REGISTRATION Clinicaltrials.gov identifier, NCT03234374.",2021,"These findings demonstrate that INL-001 provides immediate and extended delivery of bupivacaine and is well tolerated in patients undergoing open inguinal hernioplasty with no adverse effect on wound healing. ","['patients undergoing open inguinal hernioplasty', 'enrolled patients undergoing']","['INL-001 (Bupivacaine HCl) Implants', 'open inguinal hernioplasty to receive three INL-001 implants, each containing 100\xa0mg bupivacaine HCl (n\u2009=\u200934) or local infiltration of 0.25% bupivacaine HCl', 'bupivacaine', 'bupivacaine HCl', 'Bupivacaine HCl Infiltration', 'Acetaminophen', 'INL-001', 'INL-001 placement']","['systemic bupivacaine toxicity', 'wound healing', 'prolonged rate of absorption and clearance', 'pharmacokinetic (PK) and safety profile', 'Peak plasma concentration', 'PK blood samples']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C4284593', 'cui_str': 'Inguinal hernioplasty'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine hydrochloride'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C4284593', 'cui_str': 'Inguinal hernioplasty'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",,0.186851,"These findings demonstrate that INL-001 provides immediate and extended delivery of bupivacaine and is well tolerated in patients undergoing open inguinal hernioplasty with no adverse effect on wound healing. ","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Leiman', 'Affiliation': 'HD Research LLC, Houston, TX, USA. leimanmd@gmail.com.'}, {'ForeName': 'Gwendolyn', 'Initials': 'G', 'LastName': 'Niebler', 'Affiliation': 'Innocoll Inc, Newtown Square, PA, USA.'}, {'ForeName': 'Harold S', 'Initials': 'HS', 'LastName': 'Minkowitz', 'Affiliation': 'HD Research LLC, Houston, TX, USA.'}]",Advances in therapy,['10.1007/s12325-020-01565-x'] 1455,32994466,"A multicentre, randomised, open-label, parallel-group Phase 2b study of belotecan versus topotecan for recurrent ovarian cancer.","BACKGROUND This Phase 2b study compared the efficacy and toxicity of belotecan and topotecan in recurrent ovarian cancer. METHODS Patients with platinum-sensitive recurrent or platinum-resistant recurrent ovarian cancer (PRROC) were randomised 1:1 to receive belotecan 0.5 mg/m 2 or topotecan 1.5 mg/m 2 for five consecutive days every 3 weeks. The primary endpoint was overall response rate (ORR); secondary endpoints were progression-free survival (PFS), overall survival (OS), and toxicity. RESULTS A total of 140 (belotecan, n = 71; topotecan, n = 69) and 130 patients (belotecan, n = 66; topotecan, n = 64) were included in the intention-to-treat (ITT) and per-protocol (PP) populations. ORR did not differ significantly between the belotecan and topotecan groups (ITT, 29.6% versus 26.1%; PP, 30.3% versus 25%). Although PFS did not differ between the groups, belotecan was associated with improved OS compared with topotecan in the PP population (39.7 versus 26.6 months; P = 0.034). In particular, belotecan showed longer OS in PRROC and non-high-grade serous carcinoma (non-HGSC; PP, adjusted hazard ratios, 0.499 and 0.187; 95% confidence intervals 0.255-0.977 and 0.039-0.895). Furthermore, there were no differences in toxicities between the two groups. CONCLUSIONS Belotecan was not inferior to topotecan in terms of overall response for recurrent ovarian cancer. CLINICAL TRIAL REGISTRATION NCT01630018.",2021,"Although PFS did not differ between the groups, belotecan was associated with improved OS compared with topotecan in the PP population (39.7 versus 26.6 months; P = 0.034).","['recurrent ovarian cancer', 'Patients with platinum-sensitive recurrent or platinum-resistant recurrent ovarian cancer (PRROC', 'A total of 140 (belotecan, n\u2009=\u200971; topotecan, n\u2009=\u200969) and 130 patients (belotecan, n\u2009=\u200966; topotecan, n\u2009=\u200964) were included in the intention-to-treat (ITT) and per-protocol (PP) populations']","['belotecan 0.5\u2009mg/m 2 or topotecan 1.5\u2009mg/m 2', 'belotecan and topotecan', 'belotecan versus topotecan']","['overall response rate (ORR); secondary endpoints were progression-free survival (PFS), overall survival (OS), and toxicity', 'efficacy and toxicity', 'ORR', 'longer OS in PRROC and non-high-grade serous carcinoma', 'toxicities']","[{'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0762737', 'cui_str': 'belotecan'}, {'cui': 'C0146224', 'cui_str': 'Topotecan'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0762737', 'cui_str': 'belotecan'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0146224', 'cui_str': 'Topotecan'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C3839280', 'cui_str': 'High grade serous carcinoma'}]",140.0,0.324187,"Although PFS did not differ between the groups, belotecan was associated with improved OS compared with topotecan in the PP population (39.7 versus 26.6 months; P = 0.034).","[{'ForeName': 'Hee Seung', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, 03080, Republic of Korea.'}, {'ForeName': 'Sang-Yoon', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Center for Uterine Cancer, Research Institute and Hospital, National Cancer Center, Goyang, 10408, Republic of Korea.'}, {'ForeName': 'Chan-Yong', 'Initials': 'CY', 'LastName': 'Park', 'Affiliation': 'Department of Obstetrics and Gynecology, Gil Medical Center, Gachon University of Medicine and Science, Incheon, 21565, Republic of Korea.'}, {'ForeName': 'Young Tae', 'Initials': 'YT', 'LastName': 'Kim', 'Affiliation': ""Department of Obstetrics and Gynecology, Institute of Women's Medical Life Science, Yonsei University College of Medicine, Seoul, 03722, Republic of Korea.""}, {'ForeName': 'Beob-Jong', 'Initials': 'BJ', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynecology, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, Seoul, 01812, Republic of Korea.'}, {'ForeName': 'Yong Jung', 'Initials': 'YJ', 'LastName': 'Song', 'Affiliation': 'Department of Obstetrics and Gynecology, Pusan National University School of Medicine, Yangsan, 50612, Republic of Korea.'}, {'ForeName': 'Byoung-Gie', 'Initials': 'BG', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 06351, Republic of Korea.'}, {'ForeName': 'Yong Beom', 'Initials': 'YB', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynecology, Seoul National University Bundang Hospital, Seongnam, 13620, Republic of Korea.'}, {'ForeName': 'Chi-Heum', 'Initials': 'CH', 'LastName': 'Cho', 'Affiliation': 'Department of Obstetrics and Gynecology, Dongsan Medical Center, Keimyung University, Daegu, 42601, Republic of Korea.'}, {'ForeName': 'Jong-Hyeok', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, 05505, Republic of Korea.'}, {'ForeName': 'Yong Sang', 'Initials': 'YS', 'LastName': 'Song', 'Affiliation': 'Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, 03080, Republic of Korea. yssong@snu.ac.kr.'}]",British journal of cancer,['10.1038/s41416-020-01098-8'] 1456,33001381,Randomized Prospective Clinical Study of Spatz3® Adjustable Intragastric Balloon Treatment with a Control Group: a Large-Scale Brazilian Experiment.,"BACKGROUND To analyze the results regarding weight loss and complications related to the Spatz3® adjustable intragastric balloon (IGB) in Brazil. METHODS This randomized prospective study covered patients who had undergone treatment using a Spatz3® adjustable IGB between October 2016 and June 2018 at a private clinic in Rio de Janeiro, Brazil. The patients had a minimum body mass index (BMI) of 27 kg/m 2 . The study examined complications of Spatz3® treatment and BMI reduction, percentage of total weight loss (%TWL), and % of excess weight loss (%EWL). RESULTS One hundred eighty patients underwent a Spatz3® balloon implant in the period. The patients were randomly divided into one group in which the Spatz balloon was kept at the same volume (600 mL) throughout treatment (Control Group), and another adjustment group with 250 mL greater volume. The complication rate was 16.14%. No death or major complication occurred during the study. Mean BMI decreased from 39.51 to 32.84 kg/m 2 (p < 0.0001), bodyweight from 111.87 to 90.28 kg (p < 0.0001), and excess weight from 41.55 to 22.99 kg (p < 0.0001). The adjustment resulted in greater mean weight loss of 4.35 kg (- 8 to 17.6 kg), and the average time of the procedure was 7.12 ± 1.63 months. The upward adjustment group did not present greater %TWL, %EWL, or BMI reduction when compared with the control group (p = 0.4413, p = 0,9245, p = 0.2729, respectively). CONCLUSION This study shows that Spatz3® IGB treatment is an effective procedure for weight reduction, with no mortality but higher morbidity compared with traditional IGBs. This procedure also enabled the balloon to stay in place for longer. The efficacy of upward adjustment still requires further confirmation.",2021,"Mean BMI decreased from 39.51 to 32.84 kg/m 2 (p < 0.0001), bodyweight from 111.87 to 90.28 kg (p < 0.0001), and excess weight from 41.55 to 22.99 kg (p < 0.0001).","['One hundred eighty patients underwent a', 'patients had a minimum body mass index (BMI) of 27\xa0kg/m 2 ', 'patients who had undergone treatment using a Spatz3® adjustable IGB between October 2016 and June 2018 at a private clinic in Rio de Janeiro, Brazil']","['Spatz3® balloon implant', 'Spatz3® Adjustable Intragastric Balloon', 'Spatz3® IGB', 'Spatz balloon']","['mean weight loss', 'Mean BMI', 'death or major complication', 'complication rate', 'total weight loss (%TWL), and % of excess weight loss (%EWL', 'excess weight', 'TWL, %EWL, or BMI reduction']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0445581', 'cui_str': 'Rio'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",180.0,0.0160509,"Mean BMI decreased from 39.51 to 32.84 kg/m 2 (p < 0.0001), bodyweight from 111.87 to 90.28 kg (p < 0.0001), and excess weight from 41.55 to 22.99 kg (p < 0.0001).","[{'ForeName': 'Ricardo José', 'Initials': 'RJ', 'LastName': 'Fittipaldi-Fernandez', 'Affiliation': 'EndogastroRio Clinic, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Idiberto José', 'Initials': 'IJ', 'LastName': 'Zotarelli-Filho', 'Affiliation': 'FACERES - Faculty of Medicine , Sao Jose do Rio Preto, SP, Brazil. dr.idibertozotarelli@faceres.com.br.'}, {'ForeName': 'Cristina Fajardo', 'Initials': 'CF', 'LastName': 'Diestel', 'Affiliation': 'Department of Applied Nutrition, Nutrition Institute, Rio de Janeiro State University, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Márcia Regina Simas Torres', 'Initials': 'MRST', 'LastName': 'Klein', 'Affiliation': 'Department of Applied Nutrition, Nutrition Institute, Rio de Janeiro State University, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Marcelo Falcão', 'Initials': 'MF', 'LastName': 'de Santana', 'Affiliation': 'IFEC-Instituto Falcão de Endoscopia e Cirurgia (Falcão Institute of Endoscopy and Surgery), Salvador, BA, Brazil.'}, {'ForeName': 'João Henrique Felicio', 'Initials': 'JHF', 'LastName': 'de Lima', 'Affiliation': 'Endobatel-Digestive endoscopy, Universidade Federal do Paraná-UFPR (Federal University of Paraná), Curitiba, PR, Brazil.'}, {'ForeName': 'Fernando Santos Silva', 'Initials': 'FSS', 'LastName': 'Bastos', 'Affiliation': 'IFEC-Instituto Falcão de Endoscopia e Cirurgia (Falcão Institute of Endoscopy and Surgery), Salvador, BA, Brazil.'}, {'ForeName': 'Newton Teixeira', 'Initials': 'NT', 'LastName': 'Dos Santos', 'Affiliation': 'NT Santos Serviços médicos (NT Santos-Medical services), Rio de Janeiro, RJ, Brazil.'}]",Obesity surgery,['10.1007/s11695-020-05014-0'] 1457,33003524,"Accuracy of the Dexcom G6 Glucose Sensor during Aerobic, Resistance, and Interval Exercise in Adults with Type 1 Diabetes.","The accuracy of continuous glucose monitoring (CGM) sensors may be significantly impacted by exercise. We evaluated the impact of three different types of exercise on the accuracy of the Dexcom G6 sensor. Twenty-four adults with type 1 diabetes on multiple daily injections wore a G6 sensor. Participants were randomized to aerobic, resistance, or high intensity interval training (HIIT) exercise. Each participant completed two in-clinic 30-min exercise sessions. The sensors were applied on average 5.3 days prior to the in-clinic visits (range 0.6-9.9). Capillary blood glucose (CBG) measurements with a Contour Next meter were performed before and after exercise as well as every 10 min during exercise. No CGM calibrations were performed. The median absolute relative difference (MARD) and median relative difference (MRD) of the CGM as compared with the reference CBG did not differ significantly from the start of exercise to the end exercise across all exercise types (ranges for aerobic MARD: 8.9 to 13.9% and MRD: -6.4 to 0.5%, resistance MARD: 7.7 to 14.5% and MRD: -8.3 to -2.9%, HIIT MARD: 12.1 to 16.8% and MRD: -14.3 to -9.1%). The accuracy of the no-calibration Dexcom G6 CGM was not significantly impacted by aerobic, resistance, or HIIT exercise.",2020,"The accuracy of the no-calibration Dexcom G6 CGM was not significantly impacted by aerobic, resistance, or HIIT exercise.","['Twenty-four adults with type 1 diabetes on multiple daily injections wore a G6 sensor', 'Adults with Type 1 Diabetes']","['aerobic, resistance, or high intensity interval training (HIIT) exercise']","['accuracy of continuous glucose monitoring (CGM) sensors', 'median absolute relative difference (MARD) and median relative difference (MRD', 'Capillary blood glucose (CBG) measurements']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",24.0,0.0233425,"The accuracy of the no-calibration Dexcom G6 CGM was not significantly impacted by aerobic, resistance, or HIIT exercise.","[{'ForeName': 'Florian H', 'Initials': 'FH', 'LastName': 'Guillot', 'Affiliation': 'Division of Endocrinology, Harold Schnitzer Diabetes Health Center, Oregon Health & Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Jacobs', 'Affiliation': 'Artificial Intelligence for Medical Systems Lab, Department of Biomedical Engineering, Oregon Health & Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Leah M', 'Initials': 'LM', 'LastName': 'Wilson', 'Affiliation': 'Division of Endocrinology, Harold Schnitzer Diabetes Health Center, Oregon Health & Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Joseph El', 'Initials': 'JE', 'LastName': 'Youssef', 'Affiliation': 'Division of Endocrinology, Harold Schnitzer Diabetes Health Center, Oregon Health & Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Virginia B', 'Initials': 'VB', 'LastName': 'Gabo', 'Affiliation': 'Division of Endocrinology, Harold Schnitzer Diabetes Health Center, Oregon Health & Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': 'Branigan', 'Affiliation': 'Division of Endocrinology, Harold Schnitzer Diabetes Health Center, Oregon Health & Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Nichole S', 'Initials': 'NS', 'LastName': 'Tyler', 'Affiliation': 'Artificial Intelligence for Medical Systems Lab, Department of Biomedical Engineering, Oregon Health & Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Ramsey', 'Affiliation': 'Oregon Clinical and Translational Research Institute Biostatistics & Design Program, Oregon Health & Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Riddell', 'Affiliation': 'Muscle Health Research Centre, School of Kinesiology and Health Science, York University, Toronto, ON M3J 1P3, Canada.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Castle', 'Affiliation': 'Division of Endocrinology, Harold Schnitzer Diabetes Health Center, Oregon Health & Science University, Portland, OR 97239, USA.'}]",Biosensors,['10.3390/bios10100138'] 1458,33010767,Contact kinematics of patient-specific instrumentation versus conventional instrumentation for total knee arthroplasty.,"BACKGROUND The goal was to evaluate the joint contact kinematics of total knee arthroplasties implanted using patient-specific instrumentation (PSI) compared to conventional instrumentation (CI). We hypothesized that use of PSI would not significantly alter contact kinematics. METHODS The study was a prospective randomized controlled trial, with equal allocation of fifty patients to PSI and CI groups. At two years post-operation, patients underwent weight-bearing stereo X-ray examinations at 0°, 20°, 40°, 60°, 80°, and 100° of flexion. The shortest tibiofemoral distance on each condyle determined the contact location. Magnitude of the shortest distance was measured and condylar separation was analyzed using thresholds of 0.5 and 0.75 mm. Kinematic measurements derived from the shortest distance included anteroposterior (AP) translation, excursion, axial rotation, and paradoxical anterior motion. Pivot position and cam/post contact were also investigated. RESULTS There were no differences (p > 0.05) in medial and lateral AP contact locations, excursions, and magnitude of anterior motion, or in axial rotation, pivot patterns, frequency of cam/post engagement, frequency of medial anterior motion, and condylar separation at a 0.75 mm threshold. Significant differences were found in frequency of lateral anterior motion (p = 0.048) and condylar separation at a 0.5 mm threshold (p = 0.010). Both groups displayed typical kinematics for a fixed-bearing posterior-stabilized implant. CONCLUSIONS We found no major differences in knee kinematics between PSI and CI groups, which suggest that PSI does not provide a significant kinematic advantage over conventional instruments.",2020,Significant differences were found in frequency of lateral anterior motion (p = 0.048) and condylar separation at a 0.5 mm threshold (p = 0.010).,"['fifty patients to PSI and CI groups', 'total knee arthroplasty']","['conventional instrumentation (CI', 'patient-specific instrumentation (PSI', 'patient-specific instrumentation versus conventional instrumentation']","['contact kinematics', 'medial and lateral AP contact locations, excursions, and magnitude of anterior motion, or in axial rotation, pivot patterns, frequency of cam/post engagement, frequency of medial anterior motion, and condylar separation', 'condylar separation', 'knee kinematics', 'shortest tibiofemoral distance', 'anteroposterior (AP) translation, excursion, axial rotation, and paradoxical anterior motion', 'frequency of lateral anterior motion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]","[{'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0036679', 'cui_str': 'Separation'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0205310', 'cui_str': 'Paradoxical'}]",,0.058293,Significant differences were found in frequency of lateral anterior motion (p = 0.048) and condylar separation at a 0.5 mm threshold (p = 0.010).,"[{'ForeName': 'Jordan S', 'Initials': 'JS', 'LastName': 'Broberg', 'Affiliation': 'Department of Medical Biophysics, Schulich School of Medicine and Dentistry, Western University, 1151 Richmond Street, London, ON N6A 3K7, Canada; Imaging Research Laboratories, Robarts Research Institute, Schulich School of Medicine and Dentistry, Western University, 1151 Richmond Street, London, ON N6A 3K7, Canada; Surgical Innovation Program, Lawson Health Research Institute, 750 Base Line Road East, Suite 300, London, ON N6C 2R5, Canada. Electronic address: jbroberg@uwo.ca.'}, {'ForeName': 'Douglas D R', 'Initials': 'DDR', 'LastName': 'Naudie', 'Affiliation': 'Department of Medical Biophysics, Schulich School of Medicine and Dentistry, Western University, 1151 Richmond Street, London, ON N6A 3K7, Canada; Imaging Research Laboratories, Robarts Research Institute, Schulich School of Medicine and Dentistry, Western University, 1151 Richmond Street, London, ON N6A 3K7, Canada; Division of Orthopaedic Surgery, Department of Surgery, Schulich School of Medicine and Dentistry, Western University and London Health Sciences Centre, 339 Windermere Road, London, ON N6A 5A5, Canada.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Howard', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, Schulich School of Medicine and Dentistry, Western University and London Health Sciences Centre, 339 Windermere Road, London, ON N6A 5A5, Canada.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Vasarhelyi', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, Schulich School of Medicine and Dentistry, Western University and London Health Sciences Centre, 339 Windermere Road, London, ON N6A 5A5, Canada.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'McCalden', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, Schulich School of Medicine and Dentistry, Western University and London Health Sciences Centre, 339 Windermere Road, London, ON N6A 5A5, Canada.'}, {'ForeName': 'Matthew G', 'Initials': 'MG', 'LastName': 'Teeter', 'Affiliation': 'Department of Medical Biophysics, Schulich School of Medicine and Dentistry, Western University, 1151 Richmond Street, London, ON N6A 3K7, Canada; Imaging Research Laboratories, Robarts Research Institute, Schulich School of Medicine and Dentistry, Western University, 1151 Richmond Street, London, ON N6A 3K7, Canada; Surgical Innovation Program, Lawson Health Research Institute, 750 Base Line Road East, Suite 300, London, ON N6C 2R5, Canada; Division of Orthopaedic Surgery, Department of Surgery, Schulich School of Medicine and Dentistry, Western University and London Health Sciences Centre, 339 Windermere Road, London, ON N6A 5A5, Canada.'}]",The Knee,['10.1016/j.knee.2020.07.092'] 1459,33017047,"Low dose ketamine reduces pain perception and blood pressure, but not muscle sympathetic nerve activity, responses during a cold pressor test.","KEY POINTS Low dose ketamine is a leading medication used to provide analgesia in pre-hospital and hospital settings. Low dose ketamine is increasingly used off-label to treat conditions such as depression. In animals, ketamine stimulates the sympathetic nervous system and increases blood pressure, but these physiological consequences have not been studied in conscious humans. Our data suggest that low dose ketamine administration blunts pain perception and reduces blood pressure, but not muscle sympathetic nerve activity burst frequency, responses during a cold pressor test in healthy humans. These mechanistic, physiological results inform risk-benefit analysis for clinicians administering low dose ketamine in humans. ABSTRACT Low dose ketamine is an effective analgesic medication. However, our knowledge of the effects of ketamine on autonomic cardiovascular regulation is primarily limited to animal experiments. Notably, it is unknown if low dose ketamine influences autonomic cardiovascular responses during painful stimuli in humans. We tested the hypothesis that low dose ketamine blunts perceived pain, and blunts subsequent sympathetic and cardiovascular responses during an experimental noxious stimulus. Twenty-two adults (10F/12M; 27 ± 6 years; 26 ± 3 kg m -2 , mean ± SD) completed this randomized, crossover, placebo-controlled trial during two laboratory visits. During each visit, participants completed cold pressor tests (CPT; hand in ∼0.4°C ice bath for 2 min) pre- and 5 min post-drug administration (20 mg ketamine or saline). We compared pain perception (100 mm visual analogue scale), muscle sympathetic nerve activity (MSNA; microneurography, 12 paired recordings), and beat-to-beat blood pressure (BP; photoplethysmography) during the pre- and post-drug CPTs separately using paired, two-tailed t tests. For the pre-drug CPT, perceived pain (P = 0.4378), MSNA burst frequency responses (P = 0.7375), and mean BP responses (P = 0.6457) were not different between trials. For the post-drug CPT, ketamine compared to placebo administration attenuated perceived pain (P < 0.0001) and mean BP responses (P = 0.0047), but did not attenuate MSNA burst frequency responses (P = 0.3662). Finally, during the post-drug CPT, there was a moderate relation between cardiac output and BP responses after placebo administration (r = 0.53, P = 0.0121), but this relation was effectively absent after ketamine administration (r = -0.12, P = 0.5885). These data suggest that low dose ketamine administration attenuates perceived pain and pressor, but not MSNA burst frequency, responses during a CPT.",2021,"For the post-drug CPT, ketamine compared to placebo administration attenuated perceived pain (p<0.0001) and mean BP responses (p = 0.0047), but did not attenuate MSNA burst frequency responses (p = 0.3662).","['healthy humans', 'Twenty-two adults (10F/12M', '27±6', 'painful stimuli in humans']","['cold pressor tests (CPT; hand in ∼0.4°C ice bath for two minutes) pre- and five minutes post-drug administration (20 mg ketamine or saline', 'placebo', 'ketamine']","['mean BP responses', 'pain and pressor', 'autonomic cardiovascular regulation', 'pain perception and blood pressure', 'blood pressure', 'pain', 'pain perception (100 mm visual analog scale), muscle sympathetic nerve activity (MSNA; microneurography, 12 paired recordings) and beat-to-beat blood pressure (BP; photoplethysmography', 'cardiac output and BP responses', 'autonomic cardiovascular responses', 'pain perception and reduces blood pressure', 'MSNA burst frequency responses']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]","[{'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0556914', 'cui_str': 'Ice bath treatment'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0162599', 'cui_str': 'Photoplethysmography'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",22.0,0.134162,"For the post-drug CPT, ketamine compared to placebo administration attenuated perceived pain (p<0.0001) and mean BP responses (p = 0.0047), but did not attenuate MSNA burst frequency responses (p = 0.3662).","[{'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Watso', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas and University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Mu', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas and University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Moralez', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas and University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Matthew N', 'Initials': 'MN', 'LastName': 'Cramer', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas and University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Hendrix', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas and University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Cimino', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas and University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Luke N', 'Initials': 'LN', 'LastName': 'Belval', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas and University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Hinojosa-Laborde', 'Affiliation': 'US Army Institute of Surgical Research, JBSA Fort Sam Houston, TX, USA.'}, {'ForeName': 'Craig G', 'Initials': 'CG', 'LastName': 'Crandall', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas and University of Texas Southwestern Medical Center, Dallas, TX, USA.'}]",The Journal of physiology,['10.1113/JP280706'] 1460,33011737,Comparison of pharmacokinetics of omega-3 fatty acid supplements in monoacylglycerol or ethyl ester in humans: a randomized controlled trial.,"BACKGROUND A diet low in omega-3 fatty acids (n-3 FA) results in low plasma concentrations of docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), the two main long chain n-3 FA. n-3 FA supplements on the market are esterified in triglycerides (TG) or ethyl ester (EE); the latter is absorbed less than other esterification forms. The objective of this study was to test and compare the pharmacokinetics of n-3 FA esterified in monoacylglycerides (MAG), a predigested form, with the EE form. METHODS This study was a randomized, double-blind, crossover, controlled, clinical trial. Ten men and ten women between 18 and 60 years old were recruited. Participants received a single oral dose of 3 g of n-3 FA esterified in EE or MAG. Eleven blood samples were collected over 24 h post-dose. Plasma total lipids were extracted, methylated, and analyzed using gas chromatography. RESULTS After receiving the MAG form, plasma EPA and DHA peaked at a concentration 3 and 2.5 times higher, respectively, than with the EE form. When provided in MAG form, n-3 FA plasma concentration during the absorption phase was on average 3-5 times higher than in EE form. When n-3 FAs were provided esterified in MAG, their concentration 24 h post-dose was higher than in EE. Males had a lower n-3 FA plasma concentration than females when n-3 FAs were provided in EE but there was no sexe difference when provided in MAG. CONCLUSIONS Plasma concentration of DHA and EPA was higher when provided in MAG than EE form.",2021,"Males had a lower n-3 FA plasma concentration than females when n-3 FAs were provided in EE but there was no sexe difference when provided in MAG. ","['monoacylglycerol or ethyl ester in humans', 'Ten men and ten women between 18 and 60 years old were recruited']","['omega-3 fatty acid supplements', 'n-3 FA esterified', 'omega-3 fatty acids (n-3 FA', 'n-3 FA esterified in EE or MAG', 'n-3 FA supplements']","['n-3 FA plasma concentration', 'Plasma total lipids', 'triglycerides (TG) or ethyl ester (EE', 'plasma EPA and DHA']","[{'cui': 'C3884644', 'cui_str': '(trimethylsilyl)ethyl ester'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0014898', 'cui_str': 'Ester'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0523744', 'cui_str': 'Lipids measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C3884644', 'cui_str': '(trimethylsilyl)ethyl ester'}, {'cui': 'C0014898', 'cui_str': 'Ester'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}]",10.0,0.234533,"Males had a lower n-3 FA plasma concentration than females when n-3 FAs were provided in EE but there was no sexe difference when provided in MAG. ","[{'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Chevalier', 'Affiliation': ""Centre de Recherche sur le Vieillissement, Centre Intégré Universitaire de Santé et Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada.""}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Plourde', 'Affiliation': ""Centre de Recherche sur le Vieillissement, Centre Intégré Universitaire de Santé et Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada. Melanie.plourde2@usherbrooke.ca.""}]",European journal of clinical nutrition,['10.1038/s41430-020-00767-4'] 1461,32977404,An Exploratory Analysis of Changes in Mental Wellbeing Following Curcumin and Fish Oil Supplementation in Middle-Aged and Older Adults.,"Curcumin has previously been shown to enhance mood in non-depressed older adults. However, observed benefits were limited to short-term supplementation (4 weeks). In a 16 week randomized, double-blind, placebo-controlled, 2 × 2 factorial design trial, we supplemented overweight or obese non-depressed adults (50-80 years) with curcumin (160 mg/day), fish oil (2000 mg docosahexaenoic acid +400 mg eicosapentaenoic acid/day), or a combination of both. Secondary outcomes included mental wellbeing measures (mood states and subjective memory complaints (SMCs)) and quality of life (QoL). Furthermore, plasma apolipoprotein E4 (APOE4) was measured to determine whether APOE4 status influences responses to fish oil. Curcumin improved vigour ( p = 0.044) compared to placebo and reduced SMCs compared to no curcumin treatment ( p = 0.038). Fish oil did not affect any mood states, SMCs or QoL; however, responses to fish oil were affected by APOE4 status. In APOE4 non-carriers, fish oil increased vigour ( p = 0.030) and reduced total mood disturbances ( p = 0.048) compared to placebo. Improvements in mental wellbeing were correlated with increased QoL. Combining curcumin with fish oil did not result in additive effects. This exploratory analysis indicates that regular supplementation with either curcumin or fish oil (limited to APOE4 non-carriers) has the potential to improve some aspects of mental wellbeing in association with better QoL.",2020,Curcumin improved vigour ( p = 0.044) compared to placebo and reduced SMCs compared to no curcumin treatment ( p = 0.038).,"['non-depressed older adults', 'supplemented overweight or obese non-depressed adults (50-80 years) with', 'Middle-Aged and Older Adults']","['Fish oil', 'curcumin', 'curcumin or fish oil', 'fish oil (2000 mg docosahexaenoic acid +400 mg eicosapentaenoic acid/day), or a combination of both', 'placebo', 'Curcumin and Fish Oil Supplementation']","['SMCs', 'total mood disturbances', 'Furthermore, plasma apolipoprotein E4 (APOE4', 'mental wellbeing', 'mood states, SMCs or QoL', 'Mental Wellbeing', 'additive effects', 'mental wellbeing measures (mood states and subjective memory complaints (SMCs)) and quality of life (QoL']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}]","[{'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2939186', 'cui_str': 'Disturbance in mood'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0052201', 'cui_str': 'Apolipoprotein E4'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0442796', 'cui_str': 'Additive'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}]",,0.371043,Curcumin improved vigour ( p = 0.044) compared to placebo and reduced SMCs compared to no curcumin treatment ( p = 0.038).,"[{'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'Kuszewski', 'Affiliation': 'Clinical Nutrition Research Centre, School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan 2308, Australia.'}, {'ForeName': 'Peter R C', 'Initials': 'PRC', 'LastName': 'Howe', 'Affiliation': 'Clinical Nutrition Research Centre, School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan 2308, Australia.'}, {'ForeName': 'Rachel H X', 'Initials': 'RHX', 'LastName': 'Wong', 'Affiliation': 'Clinical Nutrition Research Centre, School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan 2308, Australia.'}]",Nutrients,['10.3390/nu12102902'] 1462,32977459,Food Addiction Is Associated with Binge Eating and Psychiatric Distress among Post-Operative Bariatric Surgery Patients and May Improve in Response to Cognitive Behavioural Therapy.,"The current study examined clinical correlates of food addiction among post-operative bariatric surgery patients, compared the clinical characteristics of patients with versus without food addiction, and examined whether a brief telephone-based cognitive behavioural therapy (Tele-CBT) intervention improves food addiction symptomatology among those with food addiction. Participants ( N = 100) completed measures of food addiction, binge eating, depression, and anxiety 1 year following bariatric surgery, were randomized to receive either Tele-CBT or standard bariatric post-operative care, and then, repeated the measure of food addiction at 1.25 and 1.5 years following surgery. Thirteen percent of patients exceeded the cut-off for food addiction at 1 year post-surgery, and this subgroup of patients reported greater binge eating characteristics and psychiatric distress compared to patients without food addiction. Among those with food addiction, Tele-CBT was found to improve food addiction symptomatology immediately following the intervention. These preliminary findings suggest that Tele-CBT may be helpful, at least in the short term, in improving food addiction symptomatology among some patients who do not experience remission of food addiction following bariatric surgery; however, these findings require replication in a larger sample.",2020,"Among those with food addiction, Tele-CBT was found to improve food addiction symptomatology immediately following the intervention.","['post-operative bariatric surgery patients', 'Participants ( N = 100) completed measures of food addiction, binge eating, depression, and anxiety 1 year following bariatric surgery']","['telephone-based cognitive behavioural therapy (Tele-CBT) intervention', 'Tele-CBT or standard bariatric post-operative care']","['binge eating characteristics and psychiatric distress', 'Binge Eating and Psychiatric Distress', 'food addiction symptomatology']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4505163', 'cui_str': 'Food Addiction'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C4505163', 'cui_str': 'Food Addiction'}]",,0.0444962,"Among those with food addiction, Tele-CBT was found to improve food addiction symptomatology immediately following the intervention.","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Cassin', 'Affiliation': 'Department of Psychology, Ryerson University, Toronto, ON M5B 2K3, Canada.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Leung', 'Affiliation': 'Centre for Mental Health, University Health Network, Toronto, ON M5T 2S8, Canada.'}, {'ForeName': 'Raed', 'Initials': 'R', 'LastName': 'Hawa', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON M5T 1R8, Canada.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Wnuk', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON M5T 1R8, Canada.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Jackson', 'Affiliation': 'Bariatric Surgery Program, Toronto Western Hospital, Toronto, ON M5T 2S8, Canada.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Sockalingam', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON M5T 1R8, Canada.'}]",Nutrients,['10.3390/nu12102905'] 1463,32977639,"Effect of a Nutrient-Rich, Food-Based Supplement Given to Rural Vietnamese Mothers Prior to or during Pregnancy on the Trajectories of Nutrient Biomarkers.","Nutrient interventions initiated after conception tend to have modest effects on maternal nutritional status and pregnancy outcomes. Thus, we compared the association between micronutrient intakes and the trajectories of their biomarkers before and during pregnancy. Data from a randomized trial of the effect of a nutrient-rich, food-based supplement given to 317 Vietnamese women prior to or during pregnancy on birth outcomes were used to assess nutrient intakes with biomarker trajectories of zinc, iron, folate, cobalamin, and vitamin A using linear mixed regression models. The circulating plasma or serum trajectories of all five micronutrients were associated to their baseline levels ( p < 0.0001). Plasma zinc trajectories were also related to farm work ( p = 0.024). Cobalamin and vitamin A trajectories were associated with gestational weight gain ( p = 0.003 and p = -0.037, respectively). In this population of rural Vietnamese women, nutrient intakes during pregnancy did not affect biomarker trajectories. The primary determinant of each nutrient biomarker trajectory was its respective baseline level prior to conception.",2020,"Cobalamin and vitamin A trajectories were associated with gestational weight gain ( p = 0.003 and p = -0.037, respectively).","['rural Vietnamese women', '317 Vietnamese women prior to or during pregnancy on birth outcomes', 'Rural Vietnamese Mothers Prior to or during Pregnancy on the Trajectories of Nutrient Biomarkers']","['nutrient-rich, food-based supplement', 'Nutrient-Rich, Food-Based Supplement Given']","['circulating plasma or serum trajectories', 'gestational weight gain', 'maternal nutritional status and pregnancy outcomes', 'Plasma zinc trajectories']","[{'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]","[{'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}]",317.0,0.0269425,"Cobalamin and vitamin A trajectories were associated with gestational weight gain ( p = 0.003 and p = -0.037, respectively).","[{'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Goletzke', 'Affiliation': 'Department of Nutritional Sciences and Toxicology, University of California Berkeley, Berkeley, CA 94720, USA.'}, {'ForeName': 'Hoang T', 'Initials': 'HT', 'LastName': 'Nga', 'Affiliation': 'National Institute of Nutrition, Hanoi 100000, Vietnam.'}, {'ForeName': 'Phi N', 'Initials': 'PN', 'LastName': 'Quyen', 'Affiliation': 'National Institute of Nutrition, Hanoi 100000, Vietnam.'}, {'ForeName': 'Tu', 'Initials': 'T', 'LastName': 'Ngu', 'Affiliation': 'National Institute of Nutrition, Hanoi 100000, Vietnam.'}, {'ForeName': 'Janet C', 'Initials': 'JC', 'LastName': 'King', 'Affiliation': 'Department of Nutritional Sciences and Toxicology, University of California Berkeley, Berkeley, CA 94720, USA.'}]",Nutrients,['10.3390/nu12102913'] 1464,32985369,Intravenous administration of tranexamic acid in total hip arthroplasty does not change the blood coagulopathy: a prospective thrombelastography analysis.,"OBJECTIVE Despite the wide use of tranexamic acid (TXA) in the perioperative period of total hip arthroplasty (THA), whether the hemostatic state changes after the application of intravenous (IV)-TXA are still unknown. The aim of this study was to investigate whether IV administration of TXA changes the blood coagulation following primary THA via thrombelastography (TEG) analysis and conventional laboratory tests. METHODS A total of 174 patients who underwent primary THA from September 2016 to July 2018 were selected. They were randomly divided into two groups, 86 patients with IV administration of 15 mg/kg TXA and 88 controls without TXA usage. Demographic data, TEG paremeters, d-dimer levels, fibrin degradation products, hemoglobin, hematocrit concentration, platelet, transfusion rates, perioperative blood loss, and the occurrence of deep vein thrombosis were collected. TEG and conventional laboratory tests were performed the day before operation, the first day after operation, and seventh day after operation. RESULTS There were no differences with regard to TEG or conventional laboratory tests between the two groups ( p > 0.05). The total blood loss and drain blood loss in the TXA group were significantly lower than those in the control group ( p < 0.05). The transfusion rates and the volume of blood transfusion of the control group were higher than those of the TXA group ( p < 0.05). CONCLUSION The administration of IV-TXA resulted in a significant reduction in total blood loss, transfusion volumes, and transfusion rates without the increase of thromboembolic complications. Moreover, it was confirmed that TXA would not change the coagulation via the TEG analysis.",2020,There were no differences with regard to TEG or conventional laboratory tests between the two groups ( p > 0.05).,"['174 patients who underwent primary THA from September 2016 to July 2018 were selected', '86 patients with', 'total hip arthroplasty (THA']","['IV-TXA', 'tranexamic acid (TXA', 'tranexamic acid', 'IV administration of 15 mg/kg TXA', 'TXA']","['total blood loss, transfusion volumes, and transfusion rates', 'thromboembolic complications', 'total blood loss and drain blood loss', 'transfusion rates and the volume of blood transfusion', 'TEG or conventional laboratory tests', 'Demographic data, TEG paremeters, d-dimer levels, fibrin degradation products, hemoglobin, hematocrit concentration, platelet, transfusion rates, perioperative blood loss, and the occurrence of deep vein thrombosis', 'blood coagulopathy']","[{'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0040017', 'cui_str': 'Thromboelastography'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0163275', 'cui_str': 'Fibrin degradation product'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}]",86.0,0.0203299,There were no differences with regard to TEG or conventional laboratory tests between the two groups ( p > 0.05).,"[{'ForeName': 'Xing-Chen', 'Initials': 'XC', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopaedics, 117910The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Ma-Ji', 'Initials': 'MJ', 'LastName': 'Sun', 'Affiliation': 'Department of Orthopaedics, 117910The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Pan', 'Affiliation': 'Department of Orthopaedics, 117910The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Rui', 'Affiliation': ""Department of Orthopaedics, Jiangsu Jiangyin People's Hospital, Jiangyin, China.""}, {'ForeName': 'Feng-Chao', 'Initials': 'FC', 'LastName': 'Zhao', 'Affiliation': 'Department of Orthopaedics, 71069The First Affiliated Hospital of Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Guo-Chun', 'Initials': 'GC', 'LastName': 'Zha', 'Affiliation': 'Department of Orthopaedics, 117910The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Pang', 'Affiliation': 'Department of Orthopaedics, 117910The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'Department of Orthopaedics, 117910The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Kai-Jin', 'Initials': 'KJ', 'LastName': 'Guo', 'Affiliation': 'Department of Orthopaedics, 117910The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}]",Journal of orthopaedic surgery (Hong Kong),['10.1177/2309499020959516'] 1465,32980788,Acceptability of real-time video counselling compared to other behavioural interventions for smoking cessation in rural and remote areas.,"BACKGROUND This study evaluated the acceptability of real-time video counselling compared to a) telephone counselling and b) written materials in assisting rural and remote residents to quit smoking. METHODS Participants were recruited into a three-arm, parallel group randomised trial and randomly allocated to either: a) real-time video counselling; b) telephone counselling; or c) written materials. At 4-months post-baseline participants completed an online survey that examined self-reported acceptability and helpfulness of the support. RESULTS Overall, 93.5 % of video counselling participants and 96.2 % of telephone counselling participants who received support thought it was acceptable for a smoking cessation advisor to contact them via video software or telephone respectively. There were significant differences between video counselling and telephone counselling groups on three of 10 acceptability or helpfulness measures. Video counselling participants had significantly lower odds of reporting the number of calls were about right (OR 0.50, 95 % CI 0.27-0.93), recommending the support to family and friends (OR 0.18, 95 % CI 0.04-0.85) and reporting the support helped with motivation to try quitting (OR 0.24, 95 % CI 0.07-0.76) compared to telephone counselling participants. Video counselling participants had significantly greater odds than written materials participants of rating the support favourably on all seven acceptability and helpfulness items compared. CONCLUSIONS Real-time video counselling for smoking cessation is acceptable and well-received by those living in rural and remote locations. Further research is required to enhance the three attributes that were less acceptable for video counselling than telephone counselling.",2020,"Video counselling participants had significantly greater odds than written materials participants of rating the support favourably on all seven acceptability and helpfulness items compared. ","['Participants', 'smoking cessation in rural and remote areas', 'assisting rural and remote residents to quit smoking']","['behavioural interventions', 'real-time video counselling compared to a) telephone counselling and b) written materials', 'real-time video counselling; b) telephone counselling; or c) written materials', 'Video counselling', 'real-time video counselling', 'video counselling']",['number of calls'],"[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1720420', 'cui_str': 'Call'}]",,0.115344,"Video counselling participants had significantly greater odds than written materials participants of rating the support favourably on all seven acceptability and helpfulness items compared. ","[{'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Byaruhanga', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia. Electronic address: Judith.byaruhanga@uon.edu.au.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wiggers', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia.'}, {'ForeName': 'Christine L', 'Initials': 'CL', 'LastName': 'Paul', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Byrnes', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Mitchell', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lecathelinais', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Tzelepis', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108296'] 1466,32989891,"Dentistry students' experiences, engagement and perception of biochemistry within the dental curriculum and beyond.","INTRODUCTION/OBJECTIVES Basic knowledge at the molecular level is necessary to care for the orofacial complex as part of the whole body. Many undergraduate dentistry students struggle to engage with biochemistry during the degree due to difficulty in appreciating the relevance of biochemistry to clinical practice. This study investigated student experiences, perception and engagement with biochemistry as part of the dental curriculum and explored how the teaching of biochemistry might be further developed. METHODS Focus groups were conducted with 21 participants, in groups of four to six students from the 3rd year to 5th year, as well as with recent graduates and post-graduate students from a prominent Australasian dental school. Data were analysed using a general inductive approach. RESULTS Focus group participants viewed the oral biochemistry module as well organised and professionally run. However, participants reported that the large amount of material taught in the module made them feel overwhelmed and demotivated. Biochemistry was regarded by undergraduate participants as relevant to dental practice, but graduate participants thought it was only relevant to those sitting examinations for further training. Biochemistry was perceived as most relevant to dental research and expanding scientific literacy. DISCUSSION/CONCLUSIONS Participants in this study suggested that reducing the amount of material taught, focusing on dentally relevant biochemical concepts and overtly stating the connection of biochemistry to clinical practice could increase engagement and enhance the module within the dental curriculum.",2021,"Biochemistry was regarded by undergraduate participants as relevant to dental practice, but graduate participants thought it was only relevant to those sitting examinations for further training.","['undergraduate participants as relevant to dental practice, but graduate participants thought it was only relevant to those sitting examinations for further training', 'Focus groups were conducted with 21 participants, in groups of four to six students from the 3 rd to 5th year, as well as with recent graduates and post-graduate students from a prominent Australasian dental school']",[],[],"[{'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205402', 'cui_str': 'Prominent'}, {'cui': 'C0036376', 'cui_str': 'Dental School'}]",[],[],21.0,0.0234041,"Biochemistry was regarded by undergraduate participants as relevant to dental practice, but graduate participants thought it was only relevant to those sitting examinations for further training.","[{'ForeName': 'Karla Mariah Yumul', 'Initials': 'KMY', 'LastName': 'Youhanna', 'Affiliation': 'Department of Oral Sciences, Sir John Walsh Research Institute, Faculty of Dentistry, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Adam', 'Affiliation': 'Department of Oral Sciences, Sir John Walsh Research Institute, Faculty of Dentistry, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Monk', 'Affiliation': 'Department of Oral Sciences, Sir John Walsh Research Institute, Faculty of Dentistry, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Loch', 'Affiliation': 'Department of Oral Sciences, Sir John Walsh Research Institute, Faculty of Dentistry, University of Otago, Dunedin, New Zealand.'}]",European journal of dental education : official journal of the Association for Dental Education in Europe,['10.1111/eje.12607'] 1467,32989920,"Lack of Drug-Drug Interaction Between Filgotinib, a Selective JAK1 Inhibitor, and Oral Hormonal Contraceptives Levonorgestrel/Ethinyl Estradiol in Healthy Volunteers.","Filgotinib (FIL) is a potent and selective JAK1 inhibitor in clinical development for treatment of severe inflammatory diseases. A drug-drug interaction study to evaluate the potential effect of FIL on the pharmacokinetics (PK) of the oral contraceptive levonorgestrel (LEVO)/ethinyl estradiol (EE) was conducted. This was a phase 1, open-label, randomized, crossover study in healthy female subjects (N = 24). Subjects received a single dose of LEVO (150 μg)/EE (30 μg) alone (reference), or in combination with multiple-dose FIL (200 mg once daily for 15 days; test). Intensive PK sampling was conducted, and safety was assessed throughout the study. PK interactions were evaluated using 90% confidence intervals of the geometric least squares mean ratios of the test versus reference treatments. All 24 subjects enrolled completed study treatments. Coadministration of FIL with the oral contraceptive did not alter the PK of LEVO and EE; the 90% confidence intervals of the geometric least squares mean ratios were contained within bioequivalence bounds (80%-125%). Exposures of FIL were consistent with observed clinical exposure data. Study treatments were generally well tolerated. All adverse events were mild. Coadministration with FIL did not alter the PK of LEVO/EE, and hormonal contraceptives can serve as an effective contraception method for subjects on FIL treatment.",2021,Coadministration of FIL with the oral contraceptive did not alter the PK of LEVO and EE; the 90% confidence intervals of the geometric least squares mean ratios were contained within bioequivalence bounds (80%-125%).,"['Healthy Volunteers', 'All 24 subjects enrolled completed study treatments', 'healthy female subjects (N = 24']","['FIL', 'Ethinyl Estradiol', 'Filgotinib (FIL', 'LEVO (150 μg)/EE (30 μg) alone (reference), or in combination with multiple-dose FIL', 'oral contraceptive levonorgestrel (LEVO)/ethinyl estradiol (EE']","['PK of LEVO and EE', 'PK interactions', 'tolerated']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}, {'cui': 'C1868980', 'cui_str': 'Pharmacokinetic interaction'}]",24.0,0.0405786,Coadministration of FIL with the oral contraceptive did not alter the PK of LEVO and EE; the 90% confidence intervals of the geometric least squares mean ratios were contained within bioequivalence bounds (80%-125%).,"[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Begley', 'Affiliation': 'All authors are employed by Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Kacey', 'Initials': 'K', 'LastName': 'Anderson', 'Affiliation': 'All authors are employed by Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Watkins', 'Affiliation': 'All authors are employed by Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Winnie', 'Initials': 'W', 'LastName': 'Weng', 'Affiliation': 'All authors are employed by Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Ampaw', 'Affiliation': 'All authors are employed by Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Qin', 'Affiliation': 'All authors are employed by Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Kearney', 'Affiliation': 'All authors are employed by Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Mathias', 'Affiliation': 'All authors are employed by Gilead Sciences, Inc., Foster City, California, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.870'] 1468,33237533,Rapid Onset of Efficacy of Baricitinib in Chinese Patients with Moderate to Severe Rheumatoid Arthritis: Results from Study RA-BALANCE.,"INTRODUCTION Baricitinib is an oral, selective inhibitor of Janus kinase which demonstrates clinical efficacy in patients with rheumatoid arthritis (RA). This report aims to analyze the onset time of baricitinib in Chinese patients with moderately to severely active RA who had an inadequate response to methotrexate. METHODS This post hoc analysis evaluated clinical improvements of Chinese patients treated with baricitinib 4 mg once daily compared with placebo, based on data from a phase 3 study RA-BALANCE. Efficacy measures including American College of Rheumatology 20% (ACR20) response, ACR core set values, Disease Activity Score modified to include the 28 diarthrodial joint count (DAS28) using high-sensitivity C-reactive protein (hsCRP), DAS28-erythrocyte sedimentation rate, Simplified Disease Activity Index, Clinical Disease Activity Index, DAS28-hsCRP ≤ 3.2 response (low disease activity), and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) were evaluated at weeks 1, 2, 4, 8, 12, 14, 16, 20, and 24 (except for FACIT-F evaluated every 4 weeks). A logistic regression model and an analysis of covariance model were used to analyze treatment comparisons of categorical and continuous measures, respectively. RESULTS Statistically significant (p ≤ 0.05) improvements were observed as early as week 1 or 2 for the baricitinib group compared to placebo in almost all main efficacy measures. For other outcomes including 66 swollen joint count, 68 tender joint count, FACIT-F, and DAS28-hsCRP ≤ 3.2 response rate, differences were evident (p ≤ 0.05) by week 4 in the baricitinib group compared with placebo. Significant improvements in all efficacy measures were sustained through 24 weeks. CONCLUSIONS Baricitinib demonstrated a rapid onset of efficacy on ACR20 response, ACR core set values, disease activity, and patient-reported outcome improvements in Chinese patients from RA-BALANCE. TRIAL REGISTRATION ClinicalTrials.gov identifier, NCT02265705.",2021,Statistically significant (p ≤ 0.05) improvements were observed as early as week 1 or 2 for the baricitinib group compared to placebo in almost all main efficacy measures.,"['Chinese Patients with Moderate to Severe Rheumatoid Arthritis', 'patients with rheumatoid arthritis (RA', 'Chinese patients with moderately to severely active RA who had an inadequate response to methotrexate']","['placebo', 'Baricitinib']","['American College of Rheumatology 20% (ACR20) response, ACR core set values, Disease Activity Score modified to include the 28 diarthrodial joint count (DAS28) using high-sensitivity C-reactive protein (hsCRP), DAS28-erythrocyte sedimentation rate, Simplified Disease Activity Index, Clinical Disease Activity Index, DAS28-hsCRP\u2009≤\u20093.2 response (low disease activity), and Functional Assessment of Chronic Illness Therapy-Fatigue', '66 swollen joint count, 68 tender joint count, FACIT-F, and DAS28-hsCRP ≤\u20093.2 response rate', 'efficacy measures', 'ACR20 response, ACR core set values, disease activity']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4044947', 'cui_str': 'baricitinib'}]","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0451521', 'cui_str': 'Swollen joint count'}, {'cui': 'C0451530', 'cui_str': 'Tender joint count'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.145173,Statistically significant (p ≤ 0.05) improvements were observed as early as week 1 or 2 for the baricitinib group compared to placebo in almost all main efficacy measures.,"[{'ForeName': 'Zhan-Guo', 'Initials': 'ZG', 'LastName': 'Li', 'Affiliation': ""Peking University People's Hospital, Beijing, China. zhanguo_li@hotmail.com.""}, {'ForeName': 'Jian-Kang', 'Initials': 'JK', 'LastName': 'Hu', 'Affiliation': ""Jiangxi Pingxiang People's Hospital, Pingxiang, China.""}, {'ForeName': 'Xiang-Pei', 'Initials': 'XP', 'LastName': 'Li', 'Affiliation': 'The First Affiliated Hospital of USTC (Anhui Provincial Hospital), Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Xing-Fu', 'Initials': 'XF', 'LastName': 'Li', 'Affiliation': 'Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Jian-Hua', 'Initials': 'JH', 'LastName': 'Xu', 'Affiliation': 'The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Guangdong General Hospital, Guangzhou, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'First Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Chun-De', 'Initials': 'CD', 'LastName': 'Bao', 'Affiliation': 'Renji Hospital Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Dong-Yi', 'Initials': 'DY', 'LastName': 'He', 'Affiliation': 'GuangHua Hospital, Shanghai, China.'}, {'ForeName': 'Zhi-Jun', 'Initials': 'ZJ', 'LastName': 'Li', 'Affiliation': 'First Affiliated Hospital of Bengbu Medical College, Bengbu, China.'}, {'ForeName': 'Guo-Chun', 'Initials': 'GC', 'LastName': 'Wang', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Xiao-Xia', 'Initials': 'XX', 'LastName': 'Zuo', 'Affiliation': 'Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Zheng-Yu', 'Initials': 'ZY', 'LastName': 'Xiao', 'Affiliation': 'First Affiliated Hospital of Shantou University Medical College, Shantou, China.'}, {'ForeName': 'Jin-Wei', 'Initials': 'JW', 'LastName': 'Chen', 'Affiliation': 'The Second Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Xia-Fei', 'Initials': 'XF', 'LastName': 'Xin', 'Affiliation': 'Ningbo First Hospital, Ningbo, China.'}, {'ForeName': 'Jing-Yang', 'Initials': 'JY', 'LastName': 'Li', 'Affiliation': 'Zhuzhou Central Hospital, Zhuzhou, China.'}, {'ForeName': 'Lin-Di', 'Initials': 'LD', 'LastName': 'Jiang', 'Affiliation': 'Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Meng-Ru', 'Initials': 'MR', 'LastName': 'Liu', 'Affiliation': 'Eli Lilly and Company, Shanghai, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ji', 'Affiliation': 'Eli Lilly and Company, Shanghai, China.'}, {'ForeName': 'Chen-Ge', 'Initials': 'CG', 'LastName': 'Li', 'Affiliation': 'Eli Lilly and Company, Shanghai, China.'}]",Advances in therapy,['10.1007/s12325-020-01572-y'] 1469,33004464,The Impact of Empagliflozin on Obstructive Sleep Apnea and Cardiovascular and Renal Outcomes: An Exploratory Analysis of the EMPA-REG OUTCOME Trial.,"OBJECTIVE To explore the effects of empagliflozin on the incidence of obstructive sleep apnea (OSA) and its effects on metabolic, cardiovascular (CV), and renal outcomes among participants with or without OSA in the EMPA-REG OUTCOME trial. RESEARCH DESIGN AND METHODS Participants with diabetes and CV disease were randomized to empagliflozin (10 and 25 mg) or placebo daily in addition to standard of care. OSA was assessed by investigator report using Medical Dictionary for Regulatory Activities version 18.0, and CV outcomes were independently adjudicated. Analyses were performed using multivariable-adjusted Cox regression models. RESULTS OSA was reported in 391 of 7,020 (5.6%) participants at baseline. Those with OSA were more likely to be male (83% vs. 71%) and to have moderate to severe obesity (BMI ≥35 kg/m 2 ; 55% vs. 18%). Over a median of 3.1 years, empagliflozin had similar placebo-adjusted reductions in HbA 1c , waist circumference, and systolic blood pressure, regardless of OSA status, but a larger effect on weight (adjusted mean ± SE difference at week 52: OSA vs. no OSA -2.9 ± 0.5 vs. -1.9 ± 0.1 kg). Incidence of 3-point major adverse CV events, CV death, heart failure hospitalization, and incident or worsening nephropathy in the placebo group was 1.2- to 2.0-fold higher for those with baseline OSA compared with those without. Empagliflozin significantly reduced the risk for outcomes regardless of OSA status ( P -interaction all >0.05). Fifty patients reported a new diagnosis of OSA through 7 days after medication discontinuation, and this occurred less often with empagliflozin treatment (hazard ratio 0.48 [95% CI 0.27, 0.83]). CONCLUSIONS In EMPA-REG OUTCOME, participants with OSA had greater comorbidity and higher frequency of CV and renal events. Empagliflozin had favorable effects on risk factors and CV and renal outcomes regardless of preexisting OSA and may also reduce the risk for new-onset OSA.",2020,Empagliflozin significantly reduced the risk for outcomes regardless of OSA status ( P -interaction all > 0.05).,"['participants with or without OSA in the EMPA-REG OUTCOME trial', 'Participants with diabetes and CV disease']","['placebo', 'Empagliflozin', 'empagliflozin']","['new diagnosis of OSA', 'OSA status', 'comorbidity and higher frequency of CV and renal events', 'HbA 1c , waist circumference, and systolic blood pressure, regardless of OSA status', 'moderate-severe obesity', 'Incidence of 3-point major adverse CV events, CV death, heart failure hospitalization, and incident or worsening nephropathy', 'metabolic, cardiovascular (CV), and renal outcomes', 'OSA', 'Obstructive Sleep Apnea, Cardiovascular, and Renal Outcomes', 'obstructive sleep apnea (OSA']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0208940', 'cui_str': 'REG1A protein, human'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}]","[{'cui': 'C2585997', 'cui_str': 'New diagnosis'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.196974,Empagliflozin significantly reduced the risk for outcomes regardless of OSA status ( P -interaction all > 0.05).,"[{'ForeName': 'Ian J', 'Initials': 'IJ', 'LastName': 'Neeland', 'Affiliation': 'University Hospitals Harrington Heart and Vascular Institute and Case Western Reserve University School of Medicine, Cleveland, OH ian.neeland@uhhospitals.org.'}, {'ForeName': 'Bjorn', 'Initials': 'B', 'LastName': 'Eliasson', 'Affiliation': 'Department of Medicine, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Takatoshi', 'Initials': 'T', 'LastName': 'Kasai', 'Affiliation': 'Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Marx', 'Affiliation': 'Department of Internal Medicine I (Cardiology), RWTH University Hospital, Aachen, Germany.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale School of Medicine, Yale University, New Haven, CT.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Department of Medicine, Wuerzburg University Clinic, Wuerzburg, Germany.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Zwiener', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Wojeck', 'Affiliation': 'Section of Endocrinology, Yale School of Medicine, Yale University, New Haven, CT.'}, {'ForeName': 'Henry K', 'Initials': 'HK', 'LastName': 'Yaggi', 'Affiliation': 'Section of Pulmonary, Critical Care, and Sleep Medicine, Yale School of Medicine, Yale University, New Haven, CT.'}, {'ForeName': 'Odd Erik', 'Initials': 'OE', 'LastName': 'Johansen', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc20-1096'] 1470,33009197,Greater Hamstrings Muscle Hypertrophy but Similar Damage Protection after Training at Long versus Short Muscle Lengths.,"PURPOSE We investigated the effects of seated versus prone leg curl training on hamstrings muscle hypertrophy and susceptibility to eccentric exercise-induced muscle damage. METHODS Part 1: Twenty healthy adults conducted seated leg curl training with one leg (Seated-Leg) and prone with the other (Prone-Leg), at 70% one-repetition maximum (1RM), 10 repetitions per set, 5 sets per session, 2 sessions per week for 12 wk. Magnetic resonance imaging (MRI)-measured muscle volume of the individual and whole hamstrings was assessed pre- and posttraining. Part 2: Nineteen participants from part 1 and another 12 untrained controls (Control-Leg) performed eccentric phase-only leg curl exercise at 90% 1RM, 10 repetitions per set, 3 sets for each of the seated/prone conditions with each leg. MRI-measured transverse relaxation time (T2) and 1RM of seated/prone leg curl were assessed before, 24, 48, and 72 h after exercise. RESULTS Part 1: Training-induced increases in muscle volume were greater in Seated-Leg versus Prone-Leg for the whole hamstrings (+14% vs +9%) and each biarticular (+8%-24% vs +4%-19%), but not monoarticular (+10% vs +9%), hamstring muscle. Part 2: After eccentric exercise, Control-Leg had greater increases in T2 in each hamstring muscle (e.g., semitendinosus at 72 h: +52%) than Seated-Leg (+4%) and Prone-Leg (+6%). Decreases in 1RM were also greater in Control-Leg (e.g., seated/prone 1RM at 24 h: -12%/-24%) than Seated-Leg (0%/-3%) and Prone-Leg (+2%/-5%). None of the changes significantly differed between Seated-Leg and Prone-Leg at any time points. CONCLUSION Hamstrings muscle size can be more effectively increased by seated than prone leg curl training, suggesting that training at long muscle lengths promotes muscle hypertrophy, but both are similarly effective in reducing susceptibility to muscle damage.",2021,Decreases in 1RM were also greater in Control-Leg,"['Part 1: 20 healthy adults conducted', '19 participants from Part 1 and another 12 untrained controls (Control-Leg) performed']","['seated leg curl training with one leg (Seated-Leg) and prone with the other (Prone-Leg), at 70% one-repetition maximum (1RM', 'eccentric phase-only leg curl exercise', 'seated vs prone leg curl training']","['muscle volume', 'MRI-measured transverse relaxation time (T2) and 1RM of seated/prone leg curl', 'Seated-Leg and Prone-Leg', '1RM', 'MRI-measured muscle volume of the individual and whole hamstrings (WH']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0010474', 'cui_str': ""Curling's ulcers""}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0010474', 'cui_str': ""Curling's ulcers""}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}]",,0.0151948,Decreases in 1RM were also greater in Control-Leg,"[{'ForeName': 'Sumiaki', 'Initials': 'S', 'LastName': 'Maeo', 'Affiliation': 'Research Organization of Science and Technology, Ritsumeikan University, Kusatsu, Shiga, JAPAN.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'College of Sport and Health Science, Ritsumeikan University, Kusatsu, Shiga, JAPAN.'}, {'ForeName': 'Yuhang', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'College of Sport and Health Science, Ritsumeikan University, Kusatsu, Shiga, JAPAN.'}, {'ForeName': 'Hikaru', 'Initials': 'H', 'LastName': 'Sakurai', 'Affiliation': 'College of Sport and Health Science, Ritsumeikan University, Kusatsu, Shiga, JAPAN.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Kusagawa', 'Affiliation': 'College of Sport and Health Science, Ritsumeikan University, Kusatsu, Shiga, JAPAN.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Sugiyama', 'Affiliation': 'Ritsumeikan Global Innovation Research Organization, Ritsumeikan University, Kusatsu, Shiga, JAPAN.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Kanehisa', 'Affiliation': 'College of Sport and Health Science, Ritsumeikan University, Kusatsu, Shiga, JAPAN.'}, {'ForeName': 'Tadao', 'Initials': 'T', 'LastName': 'Isaka', 'Affiliation': 'College of Sport and Health Science, Ritsumeikan University, Kusatsu, Shiga, JAPAN.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002523'] 1471,33011095,Cognitive Function Improvements Mediate Exercise Intervention Effects on Physical Performance in Acutely Hospitalized Older Adults.,"OBJECTIVES An individualized, multicomponent exercise program is effective to reverse the functional and cognitive decline that frequently occur during acute care hospitalization in older patients. The aim was to determine whether improvements in cognition mediate improvements in physical function in acutely hospitalized older patients. DESIGN A single-center, single-blind randomized clinical trial. SETTING AND PARTICIPANTS Acute care for elderly (ACE) unit in a tertiary public hospital in Navarre (Spain). Hospitalized patients were randomly assigned to an exercise intervention (n = 185) or usual-care group (n = 185). The intervention consisted of a multicomponent exercise-training program performed during 5 to 7 consecutive days (2 sessions/day). The usual-care group received habitual hospital care, which included physical rehabilitation when needed. MEASURES The main endpoints were changes in cognitive function assessed by the Mini-Mental State Examination test and verbal fluency ability, and changes in physical performance by the Short Physical Performance Battery from baseline to discharge. Mediation regression models were generated using ordinary least squares with the PROCESS version 3.2 to determine links between exercise-induced improvements. RESULTS Mediation regression model analysis indicated a significant and direct beneficial effect of physical exercise on physical function (β = 2.14; P < .0001), and a significant indirect effect of global cognitive function on the direct effect (indirect effect = 0.26; 0.10 to 0.49). Verbal fluency ability also had an indirect effect (0.32; 0.16 to 0.53) on the positive effect of exercise-training on physical function. CONCLUSIONS AND IMPLICATIONS Cognitive function enhancements mediate physical function improvements in acutely hospitalized older adults after an individualized, multicomponent exercise-training program. ClinicalTrials.gov registration (NCT02300896).",2021,"Verbal fluency ability also had an indirect effect (0.32; 0.16 to 0.53) on the positive effect of exercise-training on physical function. ","['acutely hospitalized older patients', 'acutely hospitalized older adults', 'older patients', 'Acutely Hospitalized Older Adults', 'Hospitalized patients', 'Acute care for elderly (ACE) unit in a tertiary public hospital in Navarre (Spain']","['multicomponent exercise program', 'exercise-training', 'exercise intervention', 'multicomponent exercise-training program', 'Cognitive Function Improvements Mediate Exercise Intervention', 'usual-care group', 'habitual hospital care, which included physical rehabilitation when needed']","['Physical Performance', 'global cognitive function', 'cognitive function assessed by the Mini-Mental State Examination test and verbal fluency ability, and changes in physical performance by the Short Physical Performance Battery', 'Verbal fluency ability', 'physical function']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0027552', 'cui_str': 'Needed'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",185.0,0.0243896,"Verbal fluency ability also had an indirect effect (0.32; 0.16 to 0.53) on the positive effect of exercise-training on physical function. ","[{'ForeName': 'Mikel L', 'Initials': 'ML', 'LastName': 'Sáez de Asteasu', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain; CIBER of Frailty and Healthy Aging (CIBERFES), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Nicolás', 'Initials': 'N', 'LastName': 'Martínez-Velilla', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain; CIBER of Frailty and Healthy Aging (CIBERFES), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Fabricio', 'Initials': 'F', 'LastName': 'Zambom-Ferraresi', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain; CIBER of Frailty and Healthy Aging (CIBERFES), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Robinson', 'Initials': 'R', 'LastName': 'Ramírez-Vélez', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain; CIBER of Frailty and Healthy Aging (CIBERFES), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'García-Hermoso', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain; Laboratorio de Ciencias de la Actividad Física, el Deporte y la Salud, Universidad de Santiago de Chile, USACH, Santiago, Chile.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain; CIBER of Frailty and Healthy Aging (CIBERFES), Instituto de Salud Carlos III, Madrid, Spain. Electronic address: mikel.izquierdo@gmail.com.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2020.08.024'] 1472,33021047,"Academic performance of dental students: A randomised trial comparing live, audio recorded and video recorded lectures.","OBJECTIVES To compare the academic performance of 4th-year dental students randomly divided into three learning groups: live lecture, video recorded lecture and audio recorded lecture. To assess students' attitudes towards the three learning methods. MATERIALS AND METHODS 4th-year undergraduate students, enrolled in the Orthodontics Theory-1 course, were randomised into three groups receiving different teaching methods; video recorded lecture, audio recorded lecture and live lecture. Subjects were asked to answer two open-ended questions. The first was a simple basic knowledge question in which the answer involved transcribing information from the question, while the second required analytical thinking. Students were also asked to complete a questionnaire assessing their attitudes towards the three learning methods. RESULTS 94 students participated in the study and were randomly allocated to each learning method. There were no significant differences in scores between the 3 study groups when answering the basic knowledge question (P > .05). The mean score for the analytic question was significantly higher for the live lecture and video recorded lecture groups compared to the audio recorded lecture group (P < .05). The majority of students agreed that lectures were an essential part of their learning experience and that lectures allowed interaction between students and lecturer. Two-thirds of students reported that watching a video recorded lecture provided a similar learning experience to attending a live lecture. CONCLUSION Video recorded, audio recorded and live lectures were found to be equally effective for providing basic knowledge. Video recorded and live lectures were more effective than audio recorded lecture at assessing higher levels of analytical thinking. Students attending video recorded lecture performed as well as those attending the live lecture.",2021,The mean score for the analytic question was significantly higher for the live lecture and video recorded lecture groups compared to the audio recorded lecture group (P<0.05).,"['4 th year undergraduate students, enrolled in the Orthodontics Theory - 1 course', 'dental students', '94 students participated in the study']","['learning groups; live lecture, video recorded lecture, and audio recorded lecture', 'teaching methods; video recorded lecture, audio recorded lecture, and live-lecture']","['mean score for the analytic question', 'academic performance']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0039403', 'cui_str': 'Teaching Methods'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}]",94.0,0.0222829,The mean score for the analytic question was significantly higher for the live lecture and video recorded lecture groups compared to the audio recorded lecture group (P<0.05).,"[{'ForeName': 'Abedalrahman J', 'Initials': 'AJ', 'LastName': 'Shqaidef', 'Affiliation': 'Department of Orthodontics, University of Jordan, Amman, Jordan.'}, {'ForeName': 'Dima', 'Initials': 'D', 'LastName': 'Abu-Baker', 'Affiliation': 'University of Jordan, Amman, Jordan.'}, {'ForeName': 'Zaid Bakri', 'Initials': 'ZB', 'LastName': 'Al-Bitar', 'Affiliation': 'Department Pediatric Dentistry and Orthodontics, University of Jordan, Amman, Jordan.'}, {'ForeName': 'Serene', 'Initials': 'S', 'LastName': 'Badran', 'Affiliation': 'Department Pediatric Dentistry and Orthodontics, University of Jordan, Amman, Jordan.'}, {'ForeName': 'Ahmad M', 'Initials': 'AM', 'LastName': 'Hamdan', 'Affiliation': 'Department Pediatric Dentistry and Orthodontics, University of Jordan, Amman, Jordan.'}]",European journal of dental education : official journal of the Association for Dental Education in Europe,['10.1111/eje.12614'] 1473,32991345,Investigating the Matching Relationship between Physical Exercise and Stereotypic Behavior in Children with Autism.,"PURPOSE Physical exercise has been shown to be effective in reducing stereotypic behaviors in children with autism spectrum disorder. One possible mechanism concerns the matching hypothesis between exercise and behavior. The present study sought to examine this matching exercise-behavior relationship. METHODS Participants (N = 21, 17 males and 4 females, Mage = 11.07 ± 1.44 yr, Mheight = 1.46 ± 0.99 m, and Mweight = 40.60 ± 8.25 kg), with observable forms of hand-flapping and body-rocking stereotypic behaviors, underwent three separate days of conditions, one for the control condition, one for the 10-min ball-tapping exercise condition, and one for the 10-min jogging condition, in a randomized order. The frequency of each type of stereotypic behavior was videotaped from 15 min before to 60 min after the exercise. RESULTS Results revealed that only hand-flapping stereotypic behaviors were significantly reduced in the ball-tapping exercise condition (P < 0.017), whereas only body-rocking stereotypic behaviors were significantly reduced in the jogging exercise condition (P < 0.017). However, the behavioral benefit diminished at 45 min after the respective exercise. CONCLUSION Physical exercise should be topographically matched with stereotypic behavior to produce desirable behavioral benefits in children with autism spectrum disorder.",2021,"RESULTS Results revealed that only hand-flapping stereotypic behaviors were significantly reduced in the ball-tapping exercise condition (p <.017), while only body-rocking stereotypic behaviors were significantly reduced in the jogging exercise condition (p <.017).","['Participants (N = 21, 17 males and 4 females, Mage = 11.07 ± 1.44 yr, Mheight = 1.46 ± 0.99 m, and Mweight = 40.60 ± 8.25 kg), with observable forms of hand-flapping and body-rocking stereotypic behaviors, underwent three separate days of conditions, one for the control condition, one for the 10-min ball-tapping exercise condition, and one for the 10-min jogging condition, in randomized order', 'Children with Autism', 'children with autism spectrum disorder (ASD', 'children with ASD']",['Physical exercise'],"['stereotypic behaviors', 'body-rocking stereotypic behaviors', 'hand-flapping stereotypic behaviors', 'frequency of each type of stereotypic behavior', 'behavioral benefit']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C5191363', 'cui_str': '1.46'}, {'cui': 'C4517488', 'cui_str': '0.99'}, {'cui': 'C0426867', 'cui_str': 'Form of hand'}, {'cui': 'C0005899', 'cui_str': 'Repetitive rocking movements'}, {'cui': 'C0038271', 'cui_str': 'Stereotyped routines'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0022400', 'cui_str': 'Jogging'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0038271', 'cui_str': 'Stereotyped routines'}, {'cui': 'C0005899', 'cui_str': 'Repetitive rocking movements'}, {'cui': 'C0440949', 'cui_str': 'Hand flap'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0401945,"RESULTS Results revealed that only hand-flapping stereotypic behaviors were significantly reduced in the ball-tapping exercise condition (p <.017), while only body-rocking stereotypic behaviors were significantly reduced in the jogging exercise condition (p <.017).","[{'ForeName': 'Andy C Y', 'Initials': 'ACY', 'LastName': 'Tse', 'Affiliation': 'Department of Health and Physical Education, The Education University of Hong Kong, Hong Kong, CHINA.'}, {'ForeName': 'Venus H L', 'Initials': 'VHL', 'LastName': 'Liu', 'Affiliation': 'Department of Health and Physical Education, The Education University of Hong Kong, Hong Kong, CHINA.'}, {'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, Hong Kong Polytechnic University, Hong Kong, CHINA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002525'] 1474,32992440,"Gastrointestinal Tolerance of Low, Medium and High Dose Acute Oral l-Glutamine Supplementation in Healthy Adults: A Pilot Study.","l-Glutamine (GLN) is a conditionally essential amino acid which supports gastrointestinal (GI) and immune function prior to catabolic stress (e.g., strenuous exercise). Despite potential dose-dependent benefits, GI tolerance of acute high dose oral GLN supplementation is poorly characterised. Fourteen healthy males (25 ± 5 years; 1.79 ± 0.07 cm; 77.7 ± 9.8 kg; 14.8 ± 4.6% body fat) ingested 0.3 (LOW), 0.6 (MED) or 0.9 (HIGH) g·kg·FFM -1 GLN beverages, in a randomised, double-blind, counter-balanced, cross-over trial. Individual and accumulated GI symptoms were recorded using a visual analogue scale at regular intervals up to 24-h post ingestion. GLN beverages were characterised by tonicity measurement and microscopic observations. 24-h accumulated upper- and lower- and total-GI symptoms were all greater in the HIGH, compared to LOW and MED trials ( p < 0.05). Specific GI symptoms (discomfort, nausea, belching, upper GI pain) were all more pronounced on the HIGH versus LOW GLN trial ( p < 0.05). Nevertheless, most symptoms were still rated as mild. In comparison, the remaining GI symptoms were either comparable (flatulence, urge to regurgitate, bloating, lower GI pain) or absent (heart burn, vomiting, urge to defecate, abnormal stools, stitch, dizziness) between trials ( p > 0.05). All beverages were isotonic and contained a dose-dependent number of GLN crystals. Acute oral GLN ingestion in dosages up to 0.9 g·kg·FFM -1 are generally well-tolerated. However, the severity of mild GI symptoms appeared dose-dependent during the first two hours post prandial and may be due to high-concentrations of GLN crystals.",2020,"24-h accumulated upper- and lower- and total-GI symptoms were all greater in the HIGH, compared to LOW and MED trials ( p < 0.05).","['Healthy Adults', 'Fourteen healthy males (25 ± 5 years; 1.79 ± 0.07 cm; 77.7 ± 9.8 kg; 14.8 ± 4.6% body fat) ingested 0.3 (LOW), 0.6 (MED) or 0.9 (HIGH']","['l-Glutamine (GLN', 'Low, Medium and High Dose Acute Oral l-Glutamine Supplementation']","['24-h accumulated upper- and lower- and total-GI symptoms', 'severity of mild GI symptoms', 'Specific GI symptoms (discomfort, nausea, belching, upper GI pain', 'Individual and accumulated GI symptoms', 'flatulence, urge to regurgitate, bloating, lower GI pain) or absent (heart burn, vomiting, urge to defecate, abnormal stools, stitch, dizziness']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4518239', 'cui_str': '0.07'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0014724', 'cui_str': 'Eructation'}, {'cui': 'C3203348', 'cui_str': 'Upper gastrointestinal tract structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0687713', 'cui_str': 'Gastrointestinal pain'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0162287', 'cui_str': 'Abnormal feces'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",14.0,0.160877,"24-h accumulated upper- and lower- and total-GI symptoms were all greater in the HIGH, compared to LOW and MED trials ( p < 0.05).","[{'ForeName': 'Henry B', 'Initials': 'HB', 'LastName': 'Ogden', 'Affiliation': 'Faculty of Sport, Health and Wellbeing, Plymouth MARJON University, Plymouth PL6 8BH, UK.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Child', 'Affiliation': 'School of Chemical Engineering, University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'Joanne L', 'Initials': 'JL', 'LastName': 'Fallowfield', 'Affiliation': 'Institute of Naval Medicine, Alverstoke PO12 2DL, UK.'}, {'ForeName': 'Simon K', 'Initials': 'SK', 'LastName': 'Delves', 'Affiliation': 'Institute of Naval Medicine, Alverstoke PO12 2DL, UK.'}, {'ForeName': 'Caroline S', 'Initials': 'CS', 'LastName': 'Westwood', 'Affiliation': 'Faculty of Sport, Health and Wellbeing, Plymouth MARJON University, Plymouth PL6 8BH, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Millyard', 'Affiliation': 'Faculty of Sport, Health and Wellbeing, Plymouth MARJON University, Plymouth PL6 8BH, UK.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Layden', 'Affiliation': 'Faculty of Sport, Health and Wellbeing, Plymouth MARJON University, Plymouth PL6 8BH, UK.'}]",Nutrients,['10.3390/nu12102953'] 1475,32997156,Comparison of different bone graft with arthroscopy-assisted arthrodesis for the treatment of traumatic arthritis of the subtalar joint.,"AIM OF THE STUDY To compare the clinical outcomes of traumatic arthritis of the subtalar joint treated by arthroscopy-assisted arthrodesis with autologous bone graft, allogenous bone graft, artifical bone graft, and no bone graft . METHODS Sixty-two patients (64 ft) with traumatic arthritis of subtalar joint were randomly divided into four groups. The cases treated with arthroscopy-assisted arthrodesis were analyzed retrospectively. The mean follow-up time was about 22 months (18-28 months) in each group. Clinical outcomes were assessed by the American Orthopaedic Foot and Ankle Society (AOFAS) score, Visual Analog Scale (VAS), and radiographic examination. The post-operative complications in each group were recorded respectively. RESULTS All operations were successful, without incision complications. The subtalar joint obtained full osseous fusion in each group. The average time of osseous fusion was about 12 weeks. There was no significant difference in the fusion time with each group (P = 0.991). The AOFAS and VAS scores in each group were improved significantly in the pre-operative vs post-operative evaluation (all P < 0.01). The average operation time in autologous bone graft group was 74.56 ± 11.45 min which significantly different from that of other groups(P < 0.01). CONCLUSION Similar clinical outcomes were achieved among each type of bone graft. Therefore, which types of bone graft or not may be not the most important for arthroscopy-assisted subtalar arthrodesis.",2020,The AOFAS and VAS scores in each group were improved significantly in the pre-operative vs post-operative evaluation (all P < 0.01).,"['traumatic arthritis of the subtalar joint', 'Sixty-two patients (64\xa0ft) with traumatic arthritis of subtalar joint']","['arthroscopy-assisted arthrodesis', 'subtalar joint treated by arthroscopy-assisted arthrodesis with autologous bone graft, allogenous bone graft, artifical bone graft', 'bone graft with arthroscopy-assisted arthrodesis']","['fusion time', 'average time of osseous fusion', 'average operation time', 'mean follow-up time', 'AOFAS and VAS scores', 'post-operative complications', 'American Orthopaedic Foot and Ankle Society (AOFAS) score, Visual Analog Scale (VAS), and radiographic examination']","[{'cui': 'C0152086', 'cui_str': 'Traumatic arthropathy'}, {'cui': 'C0038593', 'cui_str': 'Subtalar joint structure'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0003904', 'cui_str': 'Arthroscopy'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0003881', 'cui_str': 'Arthrodesis'}, {'cui': 'C0038593', 'cui_str': 'Subtalar joint structure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1699650', 'cui_str': 'Autologous bone graft'}, {'cui': 'C0005976', 'cui_str': 'Bone graft'}]","[{'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.039365,The AOFAS and VAS scores in each group were improved significantly in the pre-operative vs post-operative evaluation (all P < 0.01).,"[{'ForeName': 'Junming', 'Initials': 'J', 'LastName': 'Wan', 'Affiliation': 'Department of joint surgery, The Seventh Affiliated Hospital, Sun Yet-sun University, No. 628 Zhenyuan road, Shenzhen, 518107, Guangdong, China. doctorwan@i.smu.edu.cn.'}, {'ForeName': 'Liangle', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Zhujiang Hospital, Southern Medical University, Guangzhou, 510515, Guangdong, China.'}, {'ForeName': 'Yuqing', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': 'Department of joint surgery, Tongde hospital of Zhejiang province, Hangzhou, 310002, Zhejiang, China.'}, {'ForeName': 'Haiyong', 'Initials': 'H', 'LastName': 'Ren', 'Affiliation': 'Department of joint surgery, Tongde hospital of Zhejiang province, Hangzhou, 310002, Zhejiang, China.'}, {'ForeName': 'Shuliang', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of joint surgery, Tongde hospital of Zhejiang province, Hangzhou, 310002, Zhejiang, China. hztree78@163.com.'}]",International orthopaedics,['10.1007/s00264-020-04834-0'] 1476,32997180,Standardizing percutaneous Microwave Ablation in the treatment of Lung Tumors: a prospective multicenter trial (MALT study).,"OBJECTIVES To prospectively assess reproducibility, safety, and efficacy of microwave ablation (MWA) in the treatment of unresectable primary and secondary pulmonary tumors. METHODS Patients with unresectable primary and metastatic lung tumors up to 4 cm were enrolled in a multicenter prospective clinical trial and underwent CT-guided MWA. Treatments were delivered using pre-defined MW power and duration settings, based on target tumor size and histology classifications. Patients were followed for up to 24 months. Treatment safety, efficacy, and reproducibility were assessed. Ablation volumes were measured at CT scan and compared with ablation volumes obtained on ex vivo bovine liver using equal treatment settings. RESULTS From September 2015 to September 2017, 69 MWAs were performed in 54 patients, achieving technical success in all cases and treatment completion without deviations from the standardized protocol in 61 procedures (88.4%). Immediate post-MWA CT scans showed ablation dimensions smaller by about 25% than in the ex vivo model; however, a remarkable volumetric increase (40%) of the treated area was observed at 1 month post-ablation. No treatment-related deaths nor complications were recorded. Treatments of equal power and duration yielded fairly reproducible ablation dimensions at 48-h post-MWA scans. In comparison with the ex vivo liver model, in vivo ablation sizes were systematically smaller, by about 25%. Overall LPR was 24.7%, with an average TLP of 8.1 months. OS rates at 12 and 24 months were 98.0% and 71.3%, respectively. CONCLUSIONS Percutaneous CT-guided MWA is a reproducible, safe, and effective treatment for malignant lung tumors up to 4 cm in size. KEY POINTS • Percutaneous MWA treatment of primary and secondary lung tumors is a repeatable, safe, and effective therapeutic option. • It provides a fairly reproducible performance on both the long and short axis of the ablation zone. • When using pre-defined treatment duration and power settings according to tumor histology and size, LPR does not increase with increasing tumor size (up to 4 cm) for both primary and metastatic tumors.",2021,No treatment-related deaths nor complications were recorded.,"['primary and secondary lung tumors', 'unresectable primary and secondary pulmonary tumors', 'Patients with unresectable primary and metastatic lung tumors up to 4 cm', 'Lung Tumors']","['Percutaneous CT-guided MWA', 'Immediate post-MWA CT scans', 'CT-guided MWA', 'Percutaneous MWA', 'percutaneous Microwave Ablation', 'microwave ablation (MWA']","['remarkable volumetric increase', 'Treatment safety, efficacy, and reproducibility', 'Ablation volumes', 'vivo ablation sizes', 'technical success', 'reproducibility, safety, and efficacy', 'ablation dimensions smaller', 'OS rates', 'Overall LPR']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0024121', 'cui_str': 'Neoplasm of lung'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0547043', 'cui_str': 'Up'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C3854551', 'cui_str': 'Microwave ablation'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]","[{'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",69.0,0.0219247,No treatment-related deaths nor complications were recorded.,"[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Iezzi', 'Affiliation': 'Dipartimento di Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia - Istituto di Radiologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.go A Gemelli 8, 00168, Rome, Italy. roberto.iezzi.md@gmail.com.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cioni', 'Affiliation': 'Division of Interventional Radiology, Department of Diagnostic and Interventional Radiology and Nuclear Medicine, Cisanello University Hospital, Pisa, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Basile', 'Affiliation': 'Radiology Unit, San Luigi Gonzaga University Hospital - Department of Oncology, University of Turin, Turin, Italy.'}, {'ForeName': 'Nevio', 'Initials': 'N', 'LastName': 'Tosoratti', 'Affiliation': 'R&D Unit, HS Hospital Service SpA, Aprilia, LT, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Posa', 'Affiliation': 'Dipartimento di Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia - Istituto di Radiologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.go A Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Busso', 'Affiliation': 'Radiology Unit, San Luigi Gonzaga University Hospital - Department of Oncology, University of Turin, Turin, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Cappelli', 'Affiliation': 'Division of Interventional Radiology, Department of Diagnostic and Interventional Radiology and Nuclear Medicine, Cisanello University Hospital, Pisa, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Margaritora', 'Affiliation': 'Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Marcello Carlo', 'Initials': 'MC', 'LastName': 'Ambrogi', 'Affiliation': 'Division of Thoracic Surgery, Cardio Vascular and Thoracic Department, University Hospital of Pisa, Pisa, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Cassano', 'Affiliation': 'Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Scandiffio', 'Affiliation': 'Division of Interventional Radiology, Department of Diagnostic and Interventional Radiology and Nuclear Medicine, Cisanello University Hospital, Pisa, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Calandri', 'Affiliation': 'Radiology Unit, San Luigi Gonzaga University Hospital - Department of Oncology, University of Turin, Turin, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Crocetti', 'Affiliation': 'Division of Interventional Radiology, Department of Diagnostic and Interventional Radiology and Nuclear Medicine, Cisanello University Hospital, Pisa, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Valentini', 'Affiliation': 'Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Manfredi', 'Affiliation': 'Dipartimento di Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia - Istituto di Radiologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.go A Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Veltri', 'Affiliation': 'Radiology Unit, San Luigi Gonzaga University Hospital - Department of Oncology, University of Turin, Turin, Italy.'}]",European radiology,['10.1007/s00330-020-07299-2'] 1477,32998206,The Effects of Long-Term Magnesium Creatine Chelate Supplementation on Repeated Sprint Ability (RAST) in Elite Soccer Players.,"AIM The aim of the study was to evaluate the effects of 16 weeks of a low dose of magnesium creatine chelate supplementation on repeated sprint ability test (RAST) results in elite soccer players. MATERIALS Twenty well-trained soccer players participated in the study. The players were divided randomly into two groups: the supplemented group (SG = 10) and placebo group (PG = 10). Out of the 20 subjects selected for the study, 16 (SG = 8, PG = 8) completed the entire experiment. The SG ingested a single dose of 5500 mg of magnesium creatine chelate (MgCr-C), in 4 capsules per day, which was 0.07 g/kg/d. The PG received an identical 4 capsules containing corn starch. Before and after the study, the RAST was performed. In the RAST, total time (TT), first and sixth 35 m sprint length (s), average power (AP) and max power (MP) were measured. Additionally, before and after the test, lactate LA (mmol/L) and acid-base equilibrium pH (-log(H + )), bicarbonates HCO 3 - (mmol/L) were evaluated. Also, in serum at rest, creatinine (mg/dL) concentration was measured. RESULTS After the study, significantly better results in TT, AP and MP were observed in the SG. No significant changes in the RAST results were observed in the PG. After the study, significant changes in the first 35 m sprint, as well as the sixth 35 m sprint results were registered in the SG, while insignificant changes occurred in the PG. A significantly higher creatinine concentration was observed. Also, a higher post-RAST concentration of LA, HCO 3 - and lower values of pH were observed in April, May and June compared with baseline values. CONCLUSIONS The long timeframe, i.e., 16 weeks, of the low dose of magnesium creatine chelate supplementation improved the RAST results in the SG. Despite the long period of MgCr-C supplementation, in the end of the study, the creatinine level in the SG reached higher but still reference values.",2020,"After the study, significantly better results in TT, AP and MP were observed in the SG.","['elite soccer players', 'Twenty well-trained soccer players participated in the study', 'Elite Soccer Players', '20 subjects selected for the study, 16 (SG = 8, PG = 8) completed the entire experiment']","['identical 4 capsules containing corn starch', 'placebo', 'magnesium creatine chelate supplementation', 'magnesium creatine chelate (MgCr-C', 'Long-Term Magnesium Creatine Chelate Supplementation']","['Repeated Sprint Ability (RAST', 'higher post-RAST concentration of LA, HCO 3 - and lower values of pH', 'serum at rest, creatinine (mg/dL) concentration', 'RAST results', 'repeated sprint ability test (RAST', 'lactate LA (mmol/L) and acid-base equilibrium pH (-log(H + )), bicarbonates HCO 3 - (mmol/L', 'TT, AP and MP', 'creatinine concentration', 'total time (TT), first and sixth 35 m sprint length (s), average power (AP) and max power (MP']","[{'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439751', 'cui_str': 'Entire'}]","[{'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1384515', 'cui_str': 'corn starch'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0007974', 'cui_str': 'Chelating agent'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0001117', 'cui_str': 'Acid-base equilibrium'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0205440', 'cui_str': 'Sixth'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",20.0,0.0681599,"After the study, significantly better results in TT, AP and MP were observed in the SG.","[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Zajac', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, Mikolowska 72a, 40-065 Katowice, Poland.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Golas', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, Mikolowska 72a, 40-065 Katowice, Poland.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Chycki', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, Mikolowska 72a, 40-065 Katowice, Poland.'}, {'ForeName': 'Mateusz', 'Initials': 'M', 'LastName': 'Halz', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, Mikolowska 72a, 40-065 Katowice, Poland.'}, {'ForeName': 'Małgorzata Magdalena', 'Initials': 'MM', 'LastName': 'Michalczyk', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, Mikolowska 72a, 40-065 Katowice, Poland.'}]",Nutrients,['10.3390/nu12102961'] 1478,32999419,Breastfeeding and maternal eating behaviours are associated with child eating behaviours: findings from the ROLO Kids Study.,"BACKGROUND Child eating behaviours can negatively contribute to the development of childhood obesity. This study investigated associations between breastfeeding habits, maternal eating behaviours and child eating behaviours, in 5-year-old children. METHODS Secundigravida women were recruited to the ROLO dietary randomised controlled trial (Dublin, Ireland) and were followed up with their children to 5 years of age. Breastfeeding exposure and duration were obtained at postnatal and infant follow-up at 2 and 6 months and 2 and 5 years. At 5 years, maternal and child eating behaviours were measured using the Three Factor Eating Questionnaire and the Child Eating Behaviour Questionnaire, respectively. Regression determined associations between breastfeeding habits and maternal eating behaviours with child eating behaviours, controlling for RCT group, maternal education level, maternal BMI at 5 years, childcare exposure and child BMI centile at 5-year follow-up. RESULTS There were 230 mother and child pairs analysed. One hundred and fifty-eight mothers had initiated breastfeeding. Median breastfeeding duration was 22 (IQR 33) weeks. Children who were never breastfed were more likely to express a desire to drink (B = -1.01, p = 0.022). Longer breastfeeding duration was associated with lower food responsiveness (B = -1.71, p = 0.003). Maternal uncontrolled eating was positively associated with child food responsiveness, emotional overeating and emotional undereating (B = 0.21, p < 0.001; B = 0.14, p = 0.005; B = 0.14, p = 0.005, respectively). Maternal emotional eating was associated with child emotional overeating and undereating (B = 0.27, p < 0.001, B = 0.29, p = 0.004, respectively). CONCLUSION Not breastfeeding and short breastfeeding duration may contribute to the development of obesogenic eating behaviours in children, alongside maternal eating behaviours including uncontrolled and emotional eating. These 'food approach' eating behaviours may increase risk of overweight/obesity as they are associated with increased energy intake, hence the importance of research surrounding eating behaviours.",2021,"Longer breastfeeding duration was associated with lower food responsiveness (B = -1.71, p = 0.003).","['One hundred and fifty-eight mothers had initiated breastfeeding', 'Secundigravida women were recruited to the ROLO dietary randomised controlled trial (Dublin, Ireland) and were followed up with their children to 5 years of age']",[],"['breastfeeding habits and maternal eating behaviours with child eating behaviours, controlling for RCT group, maternal education level, maternal BMI at 5 years, childcare exposure and child BMI centile at 5-year follow-up', 'child emotional overeating', 'Factor Eating Questionnaire and the Child Eating Behaviour Questionnaire', 'Median breastfeeding duration', 'Longer breastfeeding duration', 'Maternal emotional eating', 'child food responsiveness, emotional overeating and emotional undereating', 'Breastfeeding and maternal eating behaviours', 'Maternal uncontrolled eating', 'breastfeeding habits, maternal eating behaviours and child eating behaviours', 'obesogenic eating behaviours', 'maternal and child eating behaviours']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0454777', 'cui_str': 'Dublin'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",[],"[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0020505', 'cui_str': 'Overeating'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}]",230.0,0.0513043,"Longer breastfeeding duration was associated with lower food responsiveness (B = -1.71, p = 0.003).","[{'ForeName': 'Cara A', 'Initials': 'CA', 'LastName': 'Yelverton', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'Aisling A', 'Initials': 'AA', 'LastName': 'Geraghty', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'Eileen C', 'Initials': 'EC', 'LastName': ""O'Brien"", 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'Sarah Louise', 'Initials': 'SL', 'LastName': 'Killeen', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Horan', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'Jean M', 'Initials': 'JM', 'LastName': 'Donnelly', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Larkin', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mehegan', 'Affiliation': 'UCD School of Public Health, Physiotherapy and Sports Science, University College Dublin, Belfield, Dublin 4, Ireland.'}, {'ForeName': 'Fionnuala M', 'Initials': 'FM', 'LastName': 'McAuliffe', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin, Ireland. fionnuala.mcauliffe@ucd.ie.'}]",European journal of clinical nutrition,['10.1038/s41430-020-00764-7'] 1479,32997871,"A randomized, controlled pilot study of cognitive analytic therapy for stressed pregnant women with underlying anxiety and depression in a routine health service setting.","A pilot study of cognitive analytic therapy (CAT) plus treatment as usual (TAU), versus TAU in stressed pregnant women with anxiety and depression, was undertaken as an essential preliminary to any definitive, randomized controlled trial (RCT). The trial was pragmatic, multicentre, parallel, randomized, controlled, and unblinded. Participants were pregnant women screened using the Hospital Anxiety and Depression Scale (HADS). Treatment was standard 16-session CAT. Main outcome measures were Spielberger State/Trait Anxiety Inventory (STAI) (primary outcome measure) at 24 weeks after randomization, therefore 1 month after therapy for the CAT group; HADS; Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM); Edinburgh Postnatal Depression Scale (EPDS); 36-item Short Form Health Survey (SF-36); and a brief Experiences of Therapy Questionnaire, completed at baseline and on average at 12, 24, 40, and 82 weeks after randomization. Thirty-nine patients (CAT + TAU, n = 20; TAU, n = 19) were randomized with mean baseline STAI State scores of 50.8 (SD 11.4) and 51.1 (SD 13.3), respectively. Sixteen patients had missing primary outcome data leaving 23 (n = 11 and n = 12) patients for analysis. The mean STAI State score was 38.5 (SD 13.8) and 45.7 (SD 16.8) in the CAT and TAU groups respectively at 24 weeks after randomization, with an adjusted difference in means of 7.2 (95% confidence interval [CI]: -7.9 to 20.6). No safety issues were reported. Patient retention for the CAT group was high (18/20; 90% of patients completed therapy). Ten out of 11 (90.9%) respondents 'agreed' or 'strongly agreed' that having CAT had been 'very helpful'. The study demonstrated the feasibility of safely undertaking CAT in this setting. Outcomes showed positive trends compatible with a clinically important effect, although statistically definitive conclusions cannot be drawn in such a study.",2021,No safety issues were reported.,"['39 patients (CAT + TAU n=20: TAU =19', 'stressed pregnant women with underlying anxiety and depression in a routine health service setting', 'stressed pregnant women with anxiety and depression', '16 patients had missing primary outcome data leaving 23 (n=11, n=12) patients for analysis', 'Participants were pregnant woman screened using the']","['cognitive analytic therapy (CAT', 'cognitive analytic therapy (CAT) plus treatment as usual (TAU), versus TAU']","['Hospital Anxiety and Depression Scale (HADS', 'mean STAI-STATE score', ""HADS; CORE-OM, EPDS; SF36, and a brief 'experience of therapy' questionnaire"", 'Patient retention', 'Spielberger State/Trait Anxiety Inventory (STAI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1272257', 'cui_str': 'Cognitive analytic therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C1272257', 'cui_str': 'Cognitive analytic therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",,0.257402,No safety issues were reported.,"[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Hamilton', 'Affiliation': 'Department of Psychiatry, Sheffield Care and Social NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Saxon', 'Affiliation': 'School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Best', 'Affiliation': 'Department of Perinatal Psychiatry/MIMHS, Kent and Medway NHS & Social Care Partnership Trust, Maidstone, UK.'}, {'ForeName': 'Vivette', 'Initials': 'V', 'LastName': 'Glover', 'Affiliation': 'Institute of Reproductive and Developmental Biology, Imperial College London, London, UK.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Walters', 'Affiliation': 'School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Ian B', 'Initials': 'IB', 'LastName': 'Kerr', 'Affiliation': 'Department of Psychotherapy, Sheffield Care and Social NHS Foundation Trust, Sheffield, UK.'}]",Clinical psychology & psychotherapy,['10.1002/cpp.2520'] 1480,33004536,STRATUS: A Phase II Study of Abituzumab in Patients With Systemic Sclerosis-associated Interstitial Lung Disease.,"OBJECTIVE To investigate the effects of abituzumab in systemic sclerosis-associated interstitial lung disease (SSc-ILD). METHODS STRATUS was a phase II, double-blind, parallel-group, multicenter trial (ClinicalTrials.gov: NCT02745145). Adults (≤ 75 yrs) with SSc-ILD on stable mycophenolate were randomized (2:2:1) to receive intravenous abituzumab 1500 mg, abituzumab 500 mg, or placebo every 4 weeks for 104 weeks. The primary endpoint was the annual rate of change in absolute forced vital capacity. RESULTS STRATUS was terminated prematurely due to slow enrollment (n = 75 screened, n = 24 randomized), precluding robust analysis of efficacy. Abituzumab was well tolerated; no new safety signals were detected. CONCLUSION Further investigation of abituzumab for treatment of SSc-ILD is required.",2020,"Abituzumab was well-tolerated; no new safety signals were detected. ","['Adults (≤75 years) with SSc-ILD on stable', 'Patients with Systemic Sclerosis-associated Interstitial Lung Disease', 'STRATUS was terminated prematurely due to slow enrolment (n=75 screened, n=24 randomized']","['mycophenolate', 'Abituzumab', 'intravenous abituzumab 1500 mg, placebo, or abituzumab', 'abituzumab']","['tolerated; no new safety signals', 'annual rate of change in absolute FVC']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036429', 'cui_str': 'Sclerosis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}]",,0.120359,"Abituzumab was well-tolerated; no new safety signals were detected. ","[{'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Khanna', 'Affiliation': 'The STRATUS study was sponsored by Merck KGaA ( for all study sites residing in countries outside of the USA) or EMD Serono Research and Development Institute Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA ( for study sites residing within the USA). Merck KGaA authors were involved in the study design, collection, analysis, and interpretation of the data, and in the writing of and decision to submit the manuscript. D. Khanna, MD, MS, Professor of Medicine, University of Michigan, Scleroderma Program, Ann Arbor, Michigan, USA; D.P. Tashkin, MD, Distinguished Emeritus Professor of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA; A.U. Wells, MD, Professor of Medicine, Consultant Chest Physician, Royal Brompton Hospital, London, UK; J.R. Seibold, MD, Principal Member, Scleroderma Research Consultants, LLC, Aiken, South Carolina, USA; S. Wax, MD, PhD, Senior Medical Director, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts (at time of study), Head of Clinical Research, Neurogastrx Inc., Woburn, Massachusetts, USA (current); C. Vazquez-Mateo, PhD, Clinical Research Scientist, P. Fleuranceau-Morel, MBMS, PhD, Head of Safety Scientist, D. Damian, PhD, Director, Biostatistics, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA; C.P. Denton, PhD, FRCP, Professor of Experimental Rheumatology, Royal Free Campus, University College London, London, UK. DK has received consulting fees from Actelion, Acceleron, Arena, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CSL Behring, Corbus, Cytori, GSK, Genentech/Roche, Galapagos, Merck, Mitsubishi Tanabi, and UCB; has received grants (to the University of Michigan) as part of investigator-initiated trials from Bayer, Bristol Myers Squibb, and Pfizer; has stock options in Eicos Sciences Inc.; and is an employee of Civi BioPharma Inc. DPT has received consulting fees from EMD Serono, Boehringer-Ingelheim, and Genentech ( funder of the Scleroderma Lung Study III). AUW reports personal fees from Intermune (advisory board and speaker fees), Boehringer Ingelheim (advisory board and speaker fees), Gilead (advisory board fees), MSD (advisory board fees), Roche (advisory board and speaker fees), Bayer (advisory board and speaker fees), and Chiesi (speaker fees). JRS has received consulting fees from Atlantic, Bayer, Boehringer Ingelheim, Blade, Camurus, Corbus, DRG, EMD Serono, Eicos, Eiger, Guidepoint, Indalo, and Mitsubishi; and has stock options in BriaCell and Pacific Therapeutics. SW was an employee of EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany) at the time the study was conducted; he is now an employee of Neurogastrx Inc. CVM, PFM, and DD are employees of EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany). CPD has received research grants from GlaxoSmithKline, CSF Behring, and Inventiva; and consulting fees from EMD Serono, Roche/Genentech, Actelion, GlaxoSmithKline, Sanofi Aventis, Inventiva, CSL Behring, Boehringer- Ingelheim, Corbus, and Bayer. Address correspondence to Dr. D. Khanna, Division of Rheumatology, Department of Internal Medicine, University of Michigan Scleroderma Program, Ann Arbor, MI 48109, USA. Email: khannad@med.umich.edu. Accepted for publication September 18, 2020.'}, {'ForeName': 'Donald P', 'Initials': 'DP', 'LastName': 'Tashkin', 'Affiliation': 'The STRATUS study was sponsored by Merck KGaA ( for all study sites residing in countries outside of the USA) or EMD Serono Research and Development Institute Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA ( for study sites residing within the USA). Merck KGaA authors were involved in the study design, collection, analysis, and interpretation of the data, and in the writing of and decision to submit the manuscript. D. Khanna, MD, MS, Professor of Medicine, University of Michigan, Scleroderma Program, Ann Arbor, Michigan, USA; D.P. Tashkin, MD, Distinguished Emeritus Professor of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA; A.U. Wells, MD, Professor of Medicine, Consultant Chest Physician, Royal Brompton Hospital, London, UK; J.R. Seibold, MD, Principal Member, Scleroderma Research Consultants, LLC, Aiken, South Carolina, USA; S. Wax, MD, PhD, Senior Medical Director, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts (at time of study), Head of Clinical Research, Neurogastrx Inc., Woburn, Massachusetts, USA (current); C. Vazquez-Mateo, PhD, Clinical Research Scientist, P. Fleuranceau-Morel, MBMS, PhD, Head of Safety Scientist, D. Damian, PhD, Director, Biostatistics, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA; C.P. Denton, PhD, FRCP, Professor of Experimental Rheumatology, Royal Free Campus, University College London, London, UK. DK has received consulting fees from Actelion, Acceleron, Arena, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CSL Behring, Corbus, Cytori, GSK, Genentech/Roche, Galapagos, Merck, Mitsubishi Tanabi, and UCB; has received grants (to the University of Michigan) as part of investigator-initiated trials from Bayer, Bristol Myers Squibb, and Pfizer; has stock options in Eicos Sciences Inc.; and is an employee of Civi BioPharma Inc. DPT has received consulting fees from EMD Serono, Boehringer-Ingelheim, and Genentech ( funder of the Scleroderma Lung Study III). AUW reports personal fees from Intermune (advisory board and speaker fees), Boehringer Ingelheim (advisory board and speaker fees), Gilead (advisory board fees), MSD (advisory board fees), Roche (advisory board and speaker fees), Bayer (advisory board and speaker fees), and Chiesi (speaker fees). JRS has received consulting fees from Atlantic, Bayer, Boehringer Ingelheim, Blade, Camurus, Corbus, DRG, EMD Serono, Eicos, Eiger, Guidepoint, Indalo, and Mitsubishi; and has stock options in BriaCell and Pacific Therapeutics. SW was an employee of EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany) at the time the study was conducted; he is now an employee of Neurogastrx Inc. CVM, PFM, and DD are employees of EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany). CPD has received research grants from GlaxoSmithKline, CSF Behring, and Inventiva; and consulting fees from EMD Serono, Roche/Genentech, Actelion, GlaxoSmithKline, Sanofi Aventis, Inventiva, CSL Behring, Boehringer- Ingelheim, Corbus, and Bayer. Address correspondence to Dr. D. Khanna, Division of Rheumatology, Department of Internal Medicine, University of Michigan Scleroderma Program, Ann Arbor, MI 48109, USA. Email: khannad@med.umich.edu. Accepted for publication September 18, 2020.'}, {'ForeName': 'Athol U', 'Initials': 'AU', 'LastName': 'Wells', 'Affiliation': 'The STRATUS study was sponsored by Merck KGaA ( for all study sites residing in countries outside of the USA) or EMD Serono Research and Development Institute Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA ( for study sites residing within the USA). Merck KGaA authors were involved in the study design, collection, analysis, and interpretation of the data, and in the writing of and decision to submit the manuscript. D. Khanna, MD, MS, Professor of Medicine, University of Michigan, Scleroderma Program, Ann Arbor, Michigan, USA; D.P. Tashkin, MD, Distinguished Emeritus Professor of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA; A.U. Wells, MD, Professor of Medicine, Consultant Chest Physician, Royal Brompton Hospital, London, UK; J.R. Seibold, MD, Principal Member, Scleroderma Research Consultants, LLC, Aiken, South Carolina, USA; S. Wax, MD, PhD, Senior Medical Director, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts (at time of study), Head of Clinical Research, Neurogastrx Inc., Woburn, Massachusetts, USA (current); C. Vazquez-Mateo, PhD, Clinical Research Scientist, P. Fleuranceau-Morel, MBMS, PhD, Head of Safety Scientist, D. Damian, PhD, Director, Biostatistics, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA; C.P. Denton, PhD, FRCP, Professor of Experimental Rheumatology, Royal Free Campus, University College London, London, UK. DK has received consulting fees from Actelion, Acceleron, Arena, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CSL Behring, Corbus, Cytori, GSK, Genentech/Roche, Galapagos, Merck, Mitsubishi Tanabi, and UCB; has received grants (to the University of Michigan) as part of investigator-initiated trials from Bayer, Bristol Myers Squibb, and Pfizer; has stock options in Eicos Sciences Inc.; and is an employee of Civi BioPharma Inc. DPT has received consulting fees from EMD Serono, Boehringer-Ingelheim, and Genentech ( funder of the Scleroderma Lung Study III). AUW reports personal fees from Intermune (advisory board and speaker fees), Boehringer Ingelheim (advisory board and speaker fees), Gilead (advisory board fees), MSD (advisory board fees), Roche (advisory board and speaker fees), Bayer (advisory board and speaker fees), and Chiesi (speaker fees). JRS has received consulting fees from Atlantic, Bayer, Boehringer Ingelheim, Blade, Camurus, Corbus, DRG, EMD Serono, Eicos, Eiger, Guidepoint, Indalo, and Mitsubishi; and has stock options in BriaCell and Pacific Therapeutics. SW was an employee of EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany) at the time the study was conducted; he is now an employee of Neurogastrx Inc. CVM, PFM, and DD are employees of EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany). CPD has received research grants from GlaxoSmithKline, CSF Behring, and Inventiva; and consulting fees from EMD Serono, Roche/Genentech, Actelion, GlaxoSmithKline, Sanofi Aventis, Inventiva, CSL Behring, Boehringer- Ingelheim, Corbus, and Bayer. Address correspondence to Dr. D. Khanna, Division of Rheumatology, Department of Internal Medicine, University of Michigan Scleroderma Program, Ann Arbor, MI 48109, USA. Email: khannad@med.umich.edu. Accepted for publication September 18, 2020.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Seibold', 'Affiliation': 'The STRATUS study was sponsored by Merck KGaA ( for all study sites residing in countries outside of the USA) or EMD Serono Research and Development Institute Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA ( for study sites residing within the USA). Merck KGaA authors were involved in the study design, collection, analysis, and interpretation of the data, and in the writing of and decision to submit the manuscript. D. Khanna, MD, MS, Professor of Medicine, University of Michigan, Scleroderma Program, Ann Arbor, Michigan, USA; D.P. Tashkin, MD, Distinguished Emeritus Professor of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA; A.U. Wells, MD, Professor of Medicine, Consultant Chest Physician, Royal Brompton Hospital, London, UK; J.R. Seibold, MD, Principal Member, Scleroderma Research Consultants, LLC, Aiken, South Carolina, USA; S. Wax, MD, PhD, Senior Medical Director, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts (at time of study), Head of Clinical Research, Neurogastrx Inc., Woburn, Massachusetts, USA (current); C. Vazquez-Mateo, PhD, Clinical Research Scientist, P. Fleuranceau-Morel, MBMS, PhD, Head of Safety Scientist, D. Damian, PhD, Director, Biostatistics, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA; C.P. Denton, PhD, FRCP, Professor of Experimental Rheumatology, Royal Free Campus, University College London, London, UK. DK has received consulting fees from Actelion, Acceleron, Arena, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CSL Behring, Corbus, Cytori, GSK, Genentech/Roche, Galapagos, Merck, Mitsubishi Tanabi, and UCB; has received grants (to the University of Michigan) as part of investigator-initiated trials from Bayer, Bristol Myers Squibb, and Pfizer; has stock options in Eicos Sciences Inc.; and is an employee of Civi BioPharma Inc. DPT has received consulting fees from EMD Serono, Boehringer-Ingelheim, and Genentech ( funder of the Scleroderma Lung Study III). AUW reports personal fees from Intermune (advisory board and speaker fees), Boehringer Ingelheim (advisory board and speaker fees), Gilead (advisory board fees), MSD (advisory board fees), Roche (advisory board and speaker fees), Bayer (advisory board and speaker fees), and Chiesi (speaker fees). JRS has received consulting fees from Atlantic, Bayer, Boehringer Ingelheim, Blade, Camurus, Corbus, DRG, EMD Serono, Eicos, Eiger, Guidepoint, Indalo, and Mitsubishi; and has stock options in BriaCell and Pacific Therapeutics. SW was an employee of EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany) at the time the study was conducted; he is now an employee of Neurogastrx Inc. CVM, PFM, and DD are employees of EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany). CPD has received research grants from GlaxoSmithKline, CSF Behring, and Inventiva; and consulting fees from EMD Serono, Roche/Genentech, Actelion, GlaxoSmithKline, Sanofi Aventis, Inventiva, CSL Behring, Boehringer- Ingelheim, Corbus, and Bayer. Address correspondence to Dr. D. Khanna, Division of Rheumatology, Department of Internal Medicine, University of Michigan Scleroderma Program, Ann Arbor, MI 48109, USA. Email: khannad@med.umich.edu. Accepted for publication September 18, 2020.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Wax', 'Affiliation': 'The STRATUS study was sponsored by Merck KGaA ( for all study sites residing in countries outside of the USA) or EMD Serono Research and Development Institute Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA ( for study sites residing within the USA). Merck KGaA authors were involved in the study design, collection, analysis, and interpretation of the data, and in the writing of and decision to submit the manuscript. D. Khanna, MD, MS, Professor of Medicine, University of Michigan, Scleroderma Program, Ann Arbor, Michigan, USA; D.P. Tashkin, MD, Distinguished Emeritus Professor of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA; A.U. Wells, MD, Professor of Medicine, Consultant Chest Physician, Royal Brompton Hospital, London, UK; J.R. Seibold, MD, Principal Member, Scleroderma Research Consultants, LLC, Aiken, South Carolina, USA; S. Wax, MD, PhD, Senior Medical Director, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts (at time of study), Head of Clinical Research, Neurogastrx Inc., Woburn, Massachusetts, USA (current); C. Vazquez-Mateo, PhD, Clinical Research Scientist, P. Fleuranceau-Morel, MBMS, PhD, Head of Safety Scientist, D. Damian, PhD, Director, Biostatistics, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA; C.P. Denton, PhD, FRCP, Professor of Experimental Rheumatology, Royal Free Campus, University College London, London, UK. DK has received consulting fees from Actelion, Acceleron, Arena, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CSL Behring, Corbus, Cytori, GSK, Genentech/Roche, Galapagos, Merck, Mitsubishi Tanabi, and UCB; has received grants (to the University of Michigan) as part of investigator-initiated trials from Bayer, Bristol Myers Squibb, and Pfizer; has stock options in Eicos Sciences Inc.; and is an employee of Civi BioPharma Inc. DPT has received consulting fees from EMD Serono, Boehringer-Ingelheim, and Genentech ( funder of the Scleroderma Lung Study III). AUW reports personal fees from Intermune (advisory board and speaker fees), Boehringer Ingelheim (advisory board and speaker fees), Gilead (advisory board fees), MSD (advisory board fees), Roche (advisory board and speaker fees), Bayer (advisory board and speaker fees), and Chiesi (speaker fees). JRS has received consulting fees from Atlantic, Bayer, Boehringer Ingelheim, Blade, Camurus, Corbus, DRG, EMD Serono, Eicos, Eiger, Guidepoint, Indalo, and Mitsubishi; and has stock options in BriaCell and Pacific Therapeutics. SW was an employee of EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany) at the time the study was conducted; he is now an employee of Neurogastrx Inc. CVM, PFM, and DD are employees of EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany). CPD has received research grants from GlaxoSmithKline, CSF Behring, and Inventiva; and consulting fees from EMD Serono, Roche/Genentech, Actelion, GlaxoSmithKline, Sanofi Aventis, Inventiva, CSL Behring, Boehringer- Ingelheim, Corbus, and Bayer. Address correspondence to Dr. D. Khanna, Division of Rheumatology, Department of Internal Medicine, University of Michigan Scleroderma Program, Ann Arbor, MI 48109, USA. Email: khannad@med.umich.edu. Accepted for publication September 18, 2020.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Vazquez-Mateo', 'Affiliation': 'The STRATUS study was sponsored by Merck KGaA ( for all study sites residing in countries outside of the USA) or EMD Serono Research and Development Institute Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA ( for study sites residing within the USA). Merck KGaA authors were involved in the study design, collection, analysis, and interpretation of the data, and in the writing of and decision to submit the manuscript. D. Khanna, MD, MS, Professor of Medicine, University of Michigan, Scleroderma Program, Ann Arbor, Michigan, USA; D.P. Tashkin, MD, Distinguished Emeritus Professor of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA; A.U. Wells, MD, Professor of Medicine, Consultant Chest Physician, Royal Brompton Hospital, London, UK; J.R. Seibold, MD, Principal Member, Scleroderma Research Consultants, LLC, Aiken, South Carolina, USA; S. Wax, MD, PhD, Senior Medical Director, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts (at time of study), Head of Clinical Research, Neurogastrx Inc., Woburn, Massachusetts, USA (current); C. Vazquez-Mateo, PhD, Clinical Research Scientist, P. Fleuranceau-Morel, MBMS, PhD, Head of Safety Scientist, D. Damian, PhD, Director, Biostatistics, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA; C.P. Denton, PhD, FRCP, Professor of Experimental Rheumatology, Royal Free Campus, University College London, London, UK. DK has received consulting fees from Actelion, Acceleron, Arena, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CSL Behring, Corbus, Cytori, GSK, Genentech/Roche, Galapagos, Merck, Mitsubishi Tanabi, and UCB; has received grants (to the University of Michigan) as part of investigator-initiated trials from Bayer, Bristol Myers Squibb, and Pfizer; has stock options in Eicos Sciences Inc.; and is an employee of Civi BioPharma Inc. DPT has received consulting fees from EMD Serono, Boehringer-Ingelheim, and Genentech ( funder of the Scleroderma Lung Study III). AUW reports personal fees from Intermune (advisory board and speaker fees), Boehringer Ingelheim (advisory board and speaker fees), Gilead (advisory board fees), MSD (advisory board fees), Roche (advisory board and speaker fees), Bayer (advisory board and speaker fees), and Chiesi (speaker fees). JRS has received consulting fees from Atlantic, Bayer, Boehringer Ingelheim, Blade, Camurus, Corbus, DRG, EMD Serono, Eicos, Eiger, Guidepoint, Indalo, and Mitsubishi; and has stock options in BriaCell and Pacific Therapeutics. SW was an employee of EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany) at the time the study was conducted; he is now an employee of Neurogastrx Inc. CVM, PFM, and DD are employees of EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany). CPD has received research grants from GlaxoSmithKline, CSF Behring, and Inventiva; and consulting fees from EMD Serono, Roche/Genentech, Actelion, GlaxoSmithKline, Sanofi Aventis, Inventiva, CSL Behring, Boehringer- Ingelheim, Corbus, and Bayer. Address correspondence to Dr. D. Khanna, Division of Rheumatology, Department of Internal Medicine, University of Michigan Scleroderma Program, Ann Arbor, MI 48109, USA. Email: khannad@med.umich.edu. Accepted for publication September 18, 2020.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Fleuranceau-Morel', 'Affiliation': 'The STRATUS study was sponsored by Merck KGaA ( for all study sites residing in countries outside of the USA) or EMD Serono Research and Development Institute Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA ( for study sites residing within the USA). Merck KGaA authors were involved in the study design, collection, analysis, and interpretation of the data, and in the writing of and decision to submit the manuscript. D. Khanna, MD, MS, Professor of Medicine, University of Michigan, Scleroderma Program, Ann Arbor, Michigan, USA; D.P. Tashkin, MD, Distinguished Emeritus Professor of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA; A.U. Wells, MD, Professor of Medicine, Consultant Chest Physician, Royal Brompton Hospital, London, UK; J.R. Seibold, MD, Principal Member, Scleroderma Research Consultants, LLC, Aiken, South Carolina, USA; S. Wax, MD, PhD, Senior Medical Director, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts (at time of study), Head of Clinical Research, Neurogastrx Inc., Woburn, Massachusetts, USA (current); C. Vazquez-Mateo, PhD, Clinical Research Scientist, P. Fleuranceau-Morel, MBMS, PhD, Head of Safety Scientist, D. Damian, PhD, Director, Biostatistics, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA; C.P. Denton, PhD, FRCP, Professor of Experimental Rheumatology, Royal Free Campus, University College London, London, UK. DK has received consulting fees from Actelion, Acceleron, Arena, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CSL Behring, Corbus, Cytori, GSK, Genentech/Roche, Galapagos, Merck, Mitsubishi Tanabi, and UCB; has received grants (to the University of Michigan) as part of investigator-initiated trials from Bayer, Bristol Myers Squibb, and Pfizer; has stock options in Eicos Sciences Inc.; and is an employee of Civi BioPharma Inc. DPT has received consulting fees from EMD Serono, Boehringer-Ingelheim, and Genentech ( funder of the Scleroderma Lung Study III). AUW reports personal fees from Intermune (advisory board and speaker fees), Boehringer Ingelheim (advisory board and speaker fees), Gilead (advisory board fees), MSD (advisory board fees), Roche (advisory board and speaker fees), Bayer (advisory board and speaker fees), and Chiesi (speaker fees). JRS has received consulting fees from Atlantic, Bayer, Boehringer Ingelheim, Blade, Camurus, Corbus, DRG, EMD Serono, Eicos, Eiger, Guidepoint, Indalo, and Mitsubishi; and has stock options in BriaCell and Pacific Therapeutics. SW was an employee of EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany) at the time the study was conducted; he is now an employee of Neurogastrx Inc. CVM, PFM, and DD are employees of EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany). CPD has received research grants from GlaxoSmithKline, CSF Behring, and Inventiva; and consulting fees from EMD Serono, Roche/Genentech, Actelion, GlaxoSmithKline, Sanofi Aventis, Inventiva, CSL Behring, Boehringer- Ingelheim, Corbus, and Bayer. Address correspondence to Dr. D. Khanna, Division of Rheumatology, Department of Internal Medicine, University of Michigan Scleroderma Program, Ann Arbor, MI 48109, USA. Email: khannad@med.umich.edu. Accepted for publication September 18, 2020.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Damian', 'Affiliation': 'The STRATUS study was sponsored by Merck KGaA ( for all study sites residing in countries outside of the USA) or EMD Serono Research and Development Institute Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA ( for study sites residing within the USA). Merck KGaA authors were involved in the study design, collection, analysis, and interpretation of the data, and in the writing of and decision to submit the manuscript. D. Khanna, MD, MS, Professor of Medicine, University of Michigan, Scleroderma Program, Ann Arbor, Michigan, USA; D.P. Tashkin, MD, Distinguished Emeritus Professor of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA; A.U. Wells, MD, Professor of Medicine, Consultant Chest Physician, Royal Brompton Hospital, London, UK; J.R. Seibold, MD, Principal Member, Scleroderma Research Consultants, LLC, Aiken, South Carolina, USA; S. Wax, MD, PhD, Senior Medical Director, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts (at time of study), Head of Clinical Research, Neurogastrx Inc., Woburn, Massachusetts, USA (current); C. Vazquez-Mateo, PhD, Clinical Research Scientist, P. Fleuranceau-Morel, MBMS, PhD, Head of Safety Scientist, D. Damian, PhD, Director, Biostatistics, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA; C.P. Denton, PhD, FRCP, Professor of Experimental Rheumatology, Royal Free Campus, University College London, London, UK. DK has received consulting fees from Actelion, Acceleron, Arena, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CSL Behring, Corbus, Cytori, GSK, Genentech/Roche, Galapagos, Merck, Mitsubishi Tanabi, and UCB; has received grants (to the University of Michigan) as part of investigator-initiated trials from Bayer, Bristol Myers Squibb, and Pfizer; has stock options in Eicos Sciences Inc.; and is an employee of Civi BioPharma Inc. DPT has received consulting fees from EMD Serono, Boehringer-Ingelheim, and Genentech ( funder of the Scleroderma Lung Study III). AUW reports personal fees from Intermune (advisory board and speaker fees), Boehringer Ingelheim (advisory board and speaker fees), Gilead (advisory board fees), MSD (advisory board fees), Roche (advisory board and speaker fees), Bayer (advisory board and speaker fees), and Chiesi (speaker fees). JRS has received consulting fees from Atlantic, Bayer, Boehringer Ingelheim, Blade, Camurus, Corbus, DRG, EMD Serono, Eicos, Eiger, Guidepoint, Indalo, and Mitsubishi; and has stock options in BriaCell and Pacific Therapeutics. SW was an employee of EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany) at the time the study was conducted; he is now an employee of Neurogastrx Inc. CVM, PFM, and DD are employees of EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany). CPD has received research grants from GlaxoSmithKline, CSF Behring, and Inventiva; and consulting fees from EMD Serono, Roche/Genentech, Actelion, GlaxoSmithKline, Sanofi Aventis, Inventiva, CSL Behring, Boehringer- Ingelheim, Corbus, and Bayer. Address correspondence to Dr. D. Khanna, Division of Rheumatology, Department of Internal Medicine, University of Michigan Scleroderma Program, Ann Arbor, MI 48109, USA. Email: khannad@med.umich.edu. Accepted for publication September 18, 2020.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Denton', 'Affiliation': 'The STRATUS study was sponsored by Merck KGaA ( for all study sites residing in countries outside of the USA) or EMD Serono Research and Development Institute Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA ( for study sites residing within the USA). Merck KGaA authors were involved in the study design, collection, analysis, and interpretation of the data, and in the writing of and decision to submit the manuscript. D. Khanna, MD, MS, Professor of Medicine, University of Michigan, Scleroderma Program, Ann Arbor, Michigan, USA; D.P. Tashkin, MD, Distinguished Emeritus Professor of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA; A.U. Wells, MD, Professor of Medicine, Consultant Chest Physician, Royal Brompton Hospital, London, UK; J.R. Seibold, MD, Principal Member, Scleroderma Research Consultants, LLC, Aiken, South Carolina, USA; S. Wax, MD, PhD, Senior Medical Director, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts (at time of study), Head of Clinical Research, Neurogastrx Inc., Woburn, Massachusetts, USA (current); C. Vazquez-Mateo, PhD, Clinical Research Scientist, P. Fleuranceau-Morel, MBMS, PhD, Head of Safety Scientist, D. Damian, PhD, Director, Biostatistics, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA; C.P. Denton, PhD, FRCP, Professor of Experimental Rheumatology, Royal Free Campus, University College London, London, UK. DK has received consulting fees from Actelion, Acceleron, Arena, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CSL Behring, Corbus, Cytori, GSK, Genentech/Roche, Galapagos, Merck, Mitsubishi Tanabi, and UCB; has received grants (to the University of Michigan) as part of investigator-initiated trials from Bayer, Bristol Myers Squibb, and Pfizer; has stock options in Eicos Sciences Inc.; and is an employee of Civi BioPharma Inc. DPT has received consulting fees from EMD Serono, Boehringer-Ingelheim, and Genentech ( funder of the Scleroderma Lung Study III). AUW reports personal fees from Intermune (advisory board and speaker fees), Boehringer Ingelheim (advisory board and speaker fees), Gilead (advisory board fees), MSD (advisory board fees), Roche (advisory board and speaker fees), Bayer (advisory board and speaker fees), and Chiesi (speaker fees). JRS has received consulting fees from Atlantic, Bayer, Boehringer Ingelheim, Blade, Camurus, Corbus, DRG, EMD Serono, Eicos, Eiger, Guidepoint, Indalo, and Mitsubishi; and has stock options in BriaCell and Pacific Therapeutics. SW was an employee of EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany) at the time the study was conducted; he is now an employee of Neurogastrx Inc. CVM, PFM, and DD are employees of EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany). CPD has received research grants from GlaxoSmithKline, CSF Behring, and Inventiva; and consulting fees from EMD Serono, Roche/Genentech, Actelion, GlaxoSmithKline, Sanofi Aventis, Inventiva, CSL Behring, Boehringer- Ingelheim, Corbus, and Bayer. Address correspondence to Dr. D. Khanna, Division of Rheumatology, Department of Internal Medicine, University of Michigan Scleroderma Program, Ann Arbor, MI 48109, USA. Email: khannad@med.umich.edu. Accepted for publication September 18, 2020.'}]",The Journal of rheumatology,['10.3899/jrheum.191365'] 1481,33023785,A randomised trial of 4- versus 12-weekly administration of bone-targeted agents in patients with bone metastases from breast or castration-resistant prostate cancer.,"BACKGROUND Optimal dosing of bone-targeted agents (BTAs), in patients with bone metastases remains an important clinical question. This trial compared 4-weekly versus 12-weekly therapy. PATIENTS AND METHODS Patients with bone metastases from breast or castration-resistant prostate cancer (CRPC), who were going to start or already on BTAs, were randomised 1:1 to 4-weekly or 12-weekly BTA treatment for one year. Primary end point was change in health-related quality of life (HRQoL)-physical function European Organisation for Research and Treatment of Cancer (EORTC)-QLQ-C30). Secondary end points included pain (EORTC-QLQ-BM22), global health status (EORTC-QLQ-C30), symptomatic skeletal events (SSEs) rates and time to SSEs. Primary analysis was per protocol and a non-inferiority margin of 5 points was used. RESULTS Of 263 patients (160 breast cancer, 103 CRPC), 133 (50.6%) and 130 (49.4%) were randomised to the 4- and 12-weekly groups, respectively. BTAs included denosumab (56.3%), zoledronate (24.0%) and pamidronate (19.8%). Using repeated-measures analysis, across all time points, patients in the 4-weekly arm had a mean HRQL-physical subdomain score which was 1.2 (95% confidence interval: -1.6 to 4.0) higher than the 12-weekly arm. The study met the definition of non-inferiority for our primary outcome. Secondary outcomes showed no significant difference in scores for pain, global health status, SSE rates and SSE-free survival between arms. Subgroup analyses for cancer type, prior BTA use or BTA type showed no significant difference between arms. CONCLUSION These results in addition to those previously reported for de-escalating zoledronate and systematic reviews in both breast and prostate cancers, would support that de-escalation of commonly used BTAs is a reasonable treatment option.",2021,"Secondary outcomes showed no significant difference in scores for pain, global health status, SSE rates and SSE-free survival between arms.","['patients with bone metastases', '263 patients (160 breast cancer, 103 CRPC), 133 (50.6%) and 130 (49.4', 'patients with bone metastases from breast or castration-resistant prostate cancer', 'Patients with bone metastases from breast or castration-resistant prostate cancer (CRPC), who were going to start or already on BTAs']","['bone-targeted agents (BTAs', 'bone-targeted agents']","['mean HRQL-physical subdomain score', 'change in health-related quality of life (HRQoL)-physical function European Organisation for Research and Treatment of Cancer (EORTC)-QLQ-C30', 'scores for pain, global health status, SSE rates\xa0and SSE-free survival', 'pain (EORTC-QLQ-BM22), global health status (EORTC-QLQ-C30), symptomatic skeletal events (SSEs) rates and time to SSEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0153690', 'cui_str': 'Secondary malignant neoplasm of bone'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",263.0,0.224032,"Secondary outcomes showed no significant difference in scores for pain, global health status, SSE rates and SSE-free survival between arms.","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Clemons', 'Affiliation': 'Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, 501 Smyth Road, Box 912, Ottawa, Ontario, K1H 8L6, Canada; Cancer Therapeutics Program, Ottawa Hospital Research Institute, 501 Smyth Road, Box 511, Ottawa, Ontario, K1H 8L6, Canada; Clinical Epidemiology Program, The Ottawa Hospital Research Institute and University of Ottawa, 501 Smyth Road, Box 511, Ottawa, Ontario, K1H 8L6, Canada. Electronic address: mclemons@toh.ca.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ong', 'Affiliation': 'Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, 501 Smyth Road, Box 912, Ottawa, Ontario, K1H 8L6, Canada.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Stober', 'Affiliation': 'Cancer Therapeutics Program, Ottawa Hospital Research Institute, 501 Smyth Road, Box 511, Ottawa, Ontario, K1H 8L6, Canada.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Ernst', 'Affiliation': 'Division of Medical Oncology, Department of Oncology, London Regional Cancer Program, London Health Sciences Centre and University of Western Ontario, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Booth', 'Affiliation': 'Cancer Centre of Southeastern Ontario, 25 King Street West, Kingston, Ontario, K7L 5P9, Canada.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Canil', 'Affiliation': 'Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, 501 Smyth Road, Box 912, Ottawa, Ontario, K1H 8L6, Canada.'}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Mates', 'Affiliation': 'Cancer Centre of Southeastern Ontario, 25 King Street West, Kingston, Ontario, K7L 5P9, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Robinson', 'Affiliation': 'Cancer Centre of Southeastern Ontario, 25 King Street West, Kingston, Ontario, K7L 5P9, Canada.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Blanchette', 'Affiliation': 'Division of Medical Oncology, Department of Oncology, London Regional Cancer Program, London Health Sciences Centre and University of Western Ontario, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Anil Abraham', 'Initials': 'AA', 'LastName': 'Joy', 'Affiliation': 'Division of Medical Oncology, Department of Oncology, University of Alberta, Cross Cancer Institute, 11560 University Avenue, Edmonton, Alberta, T6G 1Z2, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hilton', 'Affiliation': 'Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, 501 Smyth Road, Box 912, Ottawa, Ontario, K1H 8L6, Canada; Cancer Therapeutics Program, Ottawa Hospital Research Institute, 501 Smyth Road, Box 511, Ottawa, Ontario, K1H 8L6, Canada.'}, {'ForeName': 'Olexiy', 'Initials': 'O', 'LastName': 'Aseyev', 'Affiliation': 'Regional Cancer Care Northwest, Thunder Bay Regional Health Sciences Centre, 980 Oliver Road, Thunder Bay, Ontario, P7B 6V4, Canada.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Pond', 'Affiliation': 'Department of Oncology, McMaster University, 699 Concession Street, Suite 4-204, Hamilton, Ontario, L8V 5C2, Canada.'}, {'ForeName': 'Ahwon', 'Initials': 'A', 'LastName': 'Jeong', 'Affiliation': 'Cancer Therapeutics Program, Ottawa Hospital Research Institute, 501 Smyth Road, Box 511, Ottawa, Ontario, K1H 8L6, Canada.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hutton', 'Affiliation': 'Clinical Epidemiology Program, The Ottawa Hospital Research Institute and University of Ottawa, 501 Smyth Road, Box 511, Ottawa, Ontario, K1H 8L6, Canada.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Mazzarello', 'Affiliation': 'Cancer Therapeutics Program, Ottawa Hospital Research Institute, 501 Smyth Road, Box 511, Ottawa, Ontario, K1H 8L6, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Vandermeer', 'Affiliation': 'Cancer Therapeutics Program, Ottawa Hospital Research Institute, 501 Smyth Road, Box 511, Ottawa, Ontario, K1H 8L6, Canada.'}, {'ForeName': 'Igal', 'Initials': 'I', 'LastName': 'Kushnir', 'Affiliation': 'Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, 501 Smyth Road, Box 912, Ottawa, Ontario, K1H 8L6, Canada.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Fergusson', 'Affiliation': 'Clinical Epidemiology Program, The Ottawa Hospital Research Institute and University of Ottawa, 501 Smyth Road, Box 511, Ottawa, Ontario, K1H 8L6, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.08.019'] 1482,33025835,Parent-Focused Sexual Abuse Prevention: Results From a Cluster Randomized Trial.,"This study tested whether a child sexual abuse (CSA) prevention program, Smart Parents-Safe and Healthy Kids (SPSHK), could be implemented as an additional module in evidence-based parent training and whether the added module might detract from the efficacy of the original program. In a cluster randomized trial, six community-based organizations were randomized to deliver Parents as Teachers (PAT) with SPSHK (PAT+SPSHK) or PAT as usual (PAT-AU). CSA-related awareness and protective behaviors, as well as general parenting behaviors taught by PAT were assessed at baseline, post-PAT, post-SPSHK, and 1-month follow-up. Multilevel analyses revealed significant group by time interactions for both awareness and behaviors ( ps < .0001), indicating the PAT+SPSHK group had significantly greater awareness of CSA and used protective behaviors more often (which were maintained at follow-up) compared to the PAT-AU group. No differences were observed in general parenting behaviors taught by PAT suggesting adding SPHSK did not interfere with PAT efficacy as originally designed. Results indicate adding SPHSK to existing parent training can significantly enhance parents' awareness of and readiness to engage in protective behavioral strategies. Implementing SPHSK as a selective prevention strategy with at-risk parents receiving parent training through child welfare infrastructures is discussed.",2020,No differences were observed in general parenting behaviors taught by PAT suggesting adding SPHSK did not interfere with PAT efficacy as originally designed.,"['child sexual abuse (CSA) prevention program, Smart Parents-Safe and Healthy Kids (SPSHK']","['Parents as Teachers (PAT) with SPSHK (PAT+SPSHK) or PAT', 'PAT+SPSHK']","['CSA-related awareness and protective behaviors', 'awareness of CSA and used protective behaviors']","[{'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]","[{'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",6.0,0.0313322,No differences were observed in general parenting behaviors taught by PAT suggesting adding SPHSK did not interfere with PAT efficacy as originally designed.,"[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Guastaferro', 'Affiliation': 'The 8082Pennsylvania State University, State College, PA, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Felt', 'Affiliation': 'The 8082Pennsylvania State University, State College, PA, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Font', 'Affiliation': 'The 8082Pennsylvania State University, State College, PA, USA.'}, {'ForeName': 'Christian M', 'Initials': 'CM', 'LastName': 'Connell', 'Affiliation': 'The 8082Pennsylvania State University, State College, PA, USA.'}, {'ForeName': 'Sheridan', 'Initials': 'S', 'LastName': 'Miyamoto', 'Affiliation': 'The 8082Pennsylvania State University, State College, PA, USA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Zadzora', 'Affiliation': 'The 8082Pennsylvania State University, State College, PA, USA.'}, {'ForeName': 'Jennie G', 'Initials': 'JG', 'LastName': 'Noll', 'Affiliation': 'The 8082Pennsylvania State University, State College, PA, USA.'}]",Child maltreatment,['10.1177/1077559520963870'] 1483,32996128,Evaluation of poly lactic-co-glycolic acid-coated β-tricalcium phosphate for alveolar ridge preservation: A multicenter randomized controlled trial.,"BACKGROUND Alveolar ridge preservation via socket grafting (ARP-SG) is indicated to attenuate physiologic alveolar bone resorption as a consequence of tooth extraction. However, a specific bone grafting material that is patently superior has not been identified yet. The aim of this randomized controlled trial was to evaluate the efficacy of a moldable alloplastic graft, Poly Lactic-Co-Glycolic Acid-Coated β-Tricalcium Phosphate (PLGA-β-TCP), for ARP purposes [Group A] compared to freeze-dried bone allograft (FDBA) particles covered with a rapidly absorbable collagen dressing (RACD) (Group B) in function of a panel of radiographic, histomorphometric, and implant-related outcomes. METHODS Patients in need of extraction of a single posterior tooth (premolar or molar) and subsequent replacement with a dental implant were recruited and randomly allocated into one of the two treatment groups. Follow-up visits took place at 1, 2, 4, 8, and 16 weeks. Cone-beam Computed Tomography (CBCT) scans were obtained at baseline and at 16 weeks. Sites were re-entered at 20 weeks for bone core biopsy harvesting and subsequent implant placement. After delivery of the final implant-supported restoration, follow-up visits were scheduled at 6 and 12 months to monitor peri-implant tissue health and marginal bone levels using standardized intraoral periapical radiographs. RESULTS A total of 45 patients were initially enrolled in the study, of whom 43 received an implant and 32 completed the study. Healing was uneventful in all sites after ARP-SG and implant placement. No site required bone augmentation to allow for implant placement. CBCT scan analyses showed no statistically significant differences between groups in terms of reduction of horizontal width, midbuccal / midlingual height and ridge volume. Histomorphometric assessments revealed a statistically significant difference between both groups in terms of mineralized tissue formation (Group A = 27.0% ± 22.1% versus Group B = 38.2% ± 12.5%; P < 0.05). On the contrary, no significant differences were observed regarding percent of remaining bone grafting material and non-mineralized tissue. No implant failed throughout the study period and marginal bone level change was negligible in both groups. CONCLUSIONS Although a higher proportion of mineralized tissue was associated with the use of FDBA+RACD compared to PLGA-β-TCP alone, both ARP-SG approaches rendered comparable outcomes in terms of maintenance of alveolar bone dimensions, feasibility of implant placement, implant survival, and peri-implant bone level stability up to 12 months post-loading.",2021,"CBCT scan analyses showed no statistically significant differences between groups in terms of reduction of horizontal width, midbuccal / midlingual height and ridge volume.","['Patients in need of extraction of a single posterior tooth (premolar or molar) and subsequent replacement with a dental implant', 'alveolar ridge preservation', 'A total of 45 patients were initially enrolled in the study, of whom 43 received an implant and 32 completed the study']","['poly Lactic-co-glycolic Acid-coated β-tricalcium phosphate', 'FDBA+RACD', 'Poly Lactic-Co-Glycolic Acid-Coated β-Tricalcium Phosphate (PLGA-β-TCP', 'PLGA-β-TCP', 'Cone-beam Computed Tomography (CBCT) scans', 'socket grafting (ARP-SG', 'freeze-dried bone allograft (FDBA) particles covered with a rapidly absorbable collagen dressing (RACD']","['remaining bone grafting material and non-mineralized tissue', 'reduction of horizontal width, midbuccal / midlingual height and ridge volume', 'marginal bone level change', 'alveolar bone dimensions, feasibility of implant placement, implant survival and peri-implant bone level stability', 'Healing', 'mineralized tissue formation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C0447411', 'cui_str': 'Alveolar ridge structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C1533643', 'cui_str': 'Glycolic acid'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0108136', 'cui_str': 'tricalcium phosphate'}, {'cui': 'C0016698', 'cui_str': 'Lyophilization'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0460884', 'cui_str': 'Collagen dressing'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}, {'cui': 'C0447411', 'cui_str': 'Alveolar ridge structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C2354284', 'cui_str': 'socket graft'}, {'cui': 'C0407564', 'cui_str': 'Allogeneic bone graft'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}]","[{'cui': 'C0181075', 'cui_str': 'Bone graft material'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",45.0,0.0886669,"CBCT scan analyses showed no statistically significant differences between groups in terms of reduction of horizontal width, midbuccal / midlingual height and ridge volume.","[{'ForeName': 'Hanae', 'Initials': 'H', 'LastName': 'Saito', 'Affiliation': 'Department of Advanced Oral Sciences and Therapeutics, Division of Periodontics, School of Dentistry, University of Maryland, Baltimore, Maryland, USA.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Couso-Queiruga', 'Affiliation': 'Department of Periodontics, College of Dentistry, University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Harlan J', 'Initials': 'HJ', 'LastName': 'Shiau', 'Affiliation': 'Department of Advanced Oral Sciences and Therapeutics, Division of Periodontics, School of Dentistry, University of Maryland, Baltimore, Maryland, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Stuhr', 'Affiliation': 'Department of Periodontics, College of Dentistry, University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Hari', 'Initials': 'H', 'LastName': 'Prasad', 'Affiliation': 'Hard Tissue Research Laboratory, The University of Minnesota School of Dentistry, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Trishul V', 'Initials': 'TV', 'LastName': 'Allareddy', 'Affiliation': 'Department of Oral Pathology, Radiology and Medicine, College of Dentistry, University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Reynolds', 'Affiliation': 'Department of Advanced Oral Sciences and Therapeutics, Division of Periodontics, School of Dentistry, University of Maryland, Baltimore, Maryland, USA.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Avila-Ortiz', 'Affiliation': 'Department of Periodontics, College of Dentistry, University of Iowa, Iowa City, Iowa, USA.'}]",Journal of periodontology,['10.1002/JPER.20-0360'] 1484,32998324,Clinical Effects of Dietary Supplementation of Lutein with High Bio-Accessibility on Macular Pigment Optical Density and Contrast Sensitivity: A Randomized Double-Blind Placebo-Controlled Parallel-Group Comparison Trial.,"Improvements in macular pigment optical density (MPOD) and contrast sensitivity after administration of 12 mg lutein alone and the timing at which efficacy is observed remain unknown. Therefore, lutein (12 mg), a crystalline formulation, was used in this study, considering its bioaccessibility. This study aimed to determine the effects of lutein administration for 16 weeks on MPOD, contrast sensitivity, and glare sensitivity, and changes in serum lutein levels were determined. The study subjects comprised 59 healthy male and female adults aged 20-69 years. The study diet included a placebo (placebo group) or a diet supplemented with 12 mg of lutein (lutein group). Each study diet was continuously administered for 16 weeks. At weeks 8 and 16, MPOD, contrast sensitivity, glare sensitivity, and serum lutein levels were evaluated. Compared with the placebo group, the lutein group showed significantly improved MPOD, contrast sensitivity, and glare sensitivity at week 16 and significantly increased serum lutein levels at weeks 8 and 16. Continuous administration of lutein for 16 weeks, considering its bioaccessibility, increased MPOD; it made the outlines of visible objects clearer and was effective in inhibiting decreases in visual function caused by glare from light.",2020,"Compared with the placebo group, the lutein group showed significantly improved MPOD, contrast sensitivity, and glare sensitivity at week 16 and significantly increased serum lutein levels at weeks 8 and 16.",['59 healthy male and female adults aged 20-69 years'],"['Dietary Supplementation of Lutein with High Bio-Accessibility', 'placebo (placebo', 'lutein', 'diet supplemented with 12 mg of lutein (lutein group', 'placebo', 'Placebo']","['Macular Pigment Optical Density and Contrast Sensitivity', 'MPOD', 'MPOD, contrast sensitivity, and glare sensitivity', 'MPOD, contrast sensitivity, and glare sensitivity, and changes in serum lutein levels', 'visual function', 'serum lutein levels', 'macular pigment optical density (MPOD) and contrast sensitivity', 'MPOD, contrast sensitivity, glare sensitivity, and serum lutein levels']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C3850163', 'cui_str': 'Macular Pigment'}, {'cui': 'C0439164', 'cui_str': 'OD units'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0278215', 'cui_str': 'Glare'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}]",59.0,0.172558,"Compared with the placebo group, the lutein group showed significantly improved MPOD, contrast sensitivity, and glare sensitivity at week 16 and significantly increased serum lutein levels at weeks 8 and 16.","[{'ForeName': 'Naomichi', 'Initials': 'N', 'LastName': 'Machida', 'Affiliation': 'Omnica Co., Ltd. TN Koshikawa Building 5th floor 4--21-7 Itabashi, Itabashiku, Tokyo 173-0004, Japan.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Kosehira', 'Affiliation': 'Graduate School of Pharmaceutical Sciences, Josai University, 1-1 Keyakidai, Sakado-city, Saitama 350-0295, Japan.'}, {'ForeName': 'Nobuyoshi', 'Initials': 'N', 'LastName': 'Kitaichi', 'Affiliation': 'Department of Ophthalmology, Health Sciences University of Hokkaido, 1757 Kanazawa, Tobetsu-cho, Ishikari-gun, Hokkaido 061-0293, Japan.'}]",Nutrients,['10.3390/nu12102966'] 1485,33006057,Effects of N-Pep-12 dietary supplementation on neurorecovery after ischemic stroke.,"BACKGROUND The aim of the study was to evaluate the effects of N-Pep-12 dietary supplementation on neurorecovery of middle-aged and older adults with cognitive impairment after ischemic stroke, using neuropsychological outcome scales. METHODS This was a pilot randomized-controlled, phase IV, academic clinical trial that aimed to assess the effect and the safety of a single daily dose of oral 90 mg of N-Pep-12 for 90 days in supporting neurorecovery, as compared with a control group, performed on middle-aged and older adults after supratentorial ischemic stroke. RESULTS Study group differences in baseline changes at day 90 for Montreal Cognitive Assessment (MoCA), Hospital Anxiety and Depression Scale (HADS) - Anxiety subscale, Color Trails 1 and Symbol Search (number incorrect) were statistically significant (Mann-Whitney U test). For MoCA at day 90, a borderline 'intermediate effect' in favour of N-PEP-12 was observed (d Cohen = 0.491, η 2 = 0.057, OR = 2.436, p = 0.010). HADS Anxiety and Color Trails 1 at day 90 registered a 'small-to-intermediate' effect in favour of N-PEP-12 (d Cohen = 0.424, η 2 = 0.043, OR = 2.157, p = 0.026; d Cohen = 0.481, η 2 = 0.055, OR = 2.3927, p = 0.013, respectively). For symbol search errors, an 'intermediate' effect in favour of the control group was observed (d Cohen = 0.501, η 2 = 0.059, OR = 2.4811, p = 0.007). CONCLUSION This exploratory clinical trial indicates a signal for the benefit of dietary supplementation with N-Pep-12 for the enhancement of neurorecovery after supratentorial ischemic stroke.",2021,"Anxiety subscale, Color Trails 1 and Symbol Search (number incorrect) were statistically significant (Mann-Whitney U test).","['neurorecovery after ischemic stroke', 'neurorecovery of middle-aged and older adults with cognitive impairment after ischemic stroke', 'middle-aged and older adults after supratentorial ischemic stroke']","['oral 90 mg of N-Pep-12', 'dietary supplementation with N-Pep-12', 'N-Pep-12 dietary supplementation']","['HADS Anxiety and Color Trails', 'Anxiety subscale, Color Trails 1 and Symbol Search (number incorrect', 'Montreal Cognitive Assessment (MoCA), Hospital Anxiety and Depression Scale (HADS) ']","[{'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0441938', 'cui_str': 'Supratentorial'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1570845', 'cui_str': 'N-PEP-12'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}]",,0.0691924,"Anxiety subscale, Color Trails 1 and Symbol Search (number incorrect) were statistically significant (Mann-Whitney U test).","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Balea', 'Affiliation': 'RoNeuro Institute for Neurological Research and Diagnostic, No. 37 Mircea Eliade Street, 4004878, Cluj-Napoca, Romania.'}, {'ForeName': 'Codruta', 'Initials': 'C', 'LastName': 'Birle', 'Affiliation': 'RoNeuro Institute for Neurological Research and Diagnostic, No. 37 Mircea Eliade Street, 4004878, Cluj-Napoca, Romania.'}, {'ForeName': 'Cezara', 'Initials': 'C', 'LastName': 'Costin', 'Affiliation': 'RoNeuro Institute for Neurological Research and Diagnostic, No. 37 Mircea Eliade Street, 4004878, Cluj-Napoca, Romania.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Marton', 'Affiliation': 'RoNeuro Institute for Neurological Research and Diagnostic, No. 37 Mircea Eliade Street, 4004878, Cluj-Napoca, Romania.'}, {'ForeName': 'Ioana Anamaria', 'Initials': 'IA', 'LastName': 'Muresanu', 'Affiliation': 'RoNeuro Institute for Neurological Research and Diagnostic, No. 37 Mircea Eliade Street, 4004878, Cluj-Napoca, Romania.'}, {'ForeName': 'Nicoleta', 'Initials': 'N', 'LastName': 'Jemna', 'Affiliation': 'RoNeuro Institute for Neurological Research and Diagnostic, No. 37 Mircea Eliade Street, 4004878, Cluj-Napoca, Romania.'}, {'ForeName': 'Livia Livint', 'Initials': 'LL', 'LastName': 'Popa', 'Affiliation': 'RoNeuro Institute for Neurological Research and Diagnostic, No. 37 Mircea Eliade Street, 4004878, Cluj-Napoca, Romania.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Slavoaca', 'Affiliation': 'RoNeuro Institute for Neurological Research and Diagnostic, No. 37 Mircea Eliade Street, 4004878, Cluj-Napoca, Romania.'}, {'ForeName': 'Olivia Verisezan', 'Initials': 'OV', 'LastName': 'Rosu', 'Affiliation': 'RoNeuro Institute for Neurological Research and Diagnostic, No. 37 Mircea Eliade Street, 4004878, Cluj-Napoca, Romania.'}, {'ForeName': 'Adina', 'Initials': 'A', 'LastName': 'Stan', 'Affiliation': 'RoNeuro Institute for Neurological Research and Diagnostic, No. 37 Mircea Eliade Street, 4004878, Cluj-Napoca, Romania.'}, {'ForeName': 'Vitalie', 'Initials': 'V', 'LastName': 'Vacaras', 'Affiliation': 'RoNeuro Institute for Neurological Research and Diagnostic, No. 37 Mircea Eliade Street, 4004878, Cluj-Napoca, Romania.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Strilciuc', 'Affiliation': 'RoNeuro Institute for Neurological Research and Diagnostic, No. 37 Mircea Eliade Street, 4004878, Cluj-Napoca, Romania.'}, {'ForeName': 'Dafin F', 'Initials': 'DF', 'LastName': 'Muresanu', 'Affiliation': 'RoNeuro Institute for Neurological Research and Diagnostic, No. 37 Mircea Eliade Street, 4004878, Cluj-Napoca, Romania. dafinm@ssnn.ro.'}]",Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology,['10.1007/s10072-020-04707-9'] 1486,33012200,Postnatal Enalapril to Improve Cardiovascular Function Following Preterm Preeclampsia (PICk-UP):: A Randomized Double-Blind Placebo-Controlled Feasibility Trial.,"Hypertensive disease in pregnancy is associated with future cardiovascular disease and, therefore, provides an opportunity to identify women who could benefit from targeted interventions aimed at reducing cardiovascular morbidity. This study focused on the highest-risk group, women with preterm preeclampsia, who have an 8-fold risk of death from future cardiovascular disease. We performed a single-center feasibility randomized controlled trial of 6 months' treatment with enalapril to improve postnatal cardiovascular function. Echocardiography and hemodynamic measurements were performed at baseline (<3 days), 6 weeks, and 6 months postdelivery on 60 women. At randomization, 88% of women had diastolic dysfunction, and 68% had concentric remodeling/hypertrophy. No difference was seen in total vascular resistance ( P =0.59) or systolic function (global longitudinal strain: P =0.14) between groups at 6 months. However, women treated with enalapril had echocardiographic measurements consistent with improved diastolic function (E/E'[the ratio of early mitral inflow velocity and early mitral annular diastolic velocity]: P =0.04) and left ventricular remodeling (relative wall thickness: P =0.01; left ventricular mass index: P =0.03) at 6 months, compared with placebo. Urinary enalapril was detectable in 85% and 63% of women in the enalapril arm at 6 weeks and 6 months, respectively. All women responded positively to taking enalapril in the future. Our study confirmed acceptability and feasibility of the study protocol with a recruitment to completion rate of 2.2 women per month. Importantly, postnatal enalapril treatment was associated with improved echocardiographic measurements; these early improvements have the potential to reduce long-term cardiovascular disease risk. A definitive, multicenter randomized controlled trial is now required to confirm these findings. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT03466333.",2020,No difference was seen in total vascular resistance ( P =0.59) or systolic function (global longitudinal strain: P =0.14) between groups at 6 months.,"['highest-risk group, women with preterm preeclampsia, who have an 8-fold risk of death from future cardiovascular disease', 'Following Preterm Preeclampsia (PICk-UP']","['enalapril', 'placebo', 'Placebo', 'Postnatal Enalapril']","['diastolic dysfunction', 'total vascular resistance', 'Echocardiography and hemodynamic measurements', 'Cardiovascular Function', 'systolic function', 'left ventricular remodeling', 'Urinary enalapril', 'echocardiographic measurements', ""diastolic function (E/E'[the ratio of early mitral inflow velocity and early mitral annular diastolic velocity"", 'postnatal cardiovascular function', 'concentric remodeling/hypertrophy']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}]","[{'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0042380', 'cui_str': 'Vascular resistance, function'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0204901', 'cui_str': 'Hemodynamic measurements'}, {'cui': 'C0007227', 'cui_str': 'Cardiovascular function'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0600520', 'cui_str': 'Left Ventricular Remodeling'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}]",60.0,0.615887,No difference was seen in total vascular resistance ( P =0.59) or systolic function (global longitudinal strain: P =0.14) between groups at 6 months.,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ormesher', 'Affiliation': 'From the Maternal and Fetal Health Research Centre, Division of Developmental Biology and Medicine (L.O., E.C., E.D.J., J.E.M.), University of Manchester, United Kingdom.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Higson', 'Affiliation': 'Manchester Heart Centre (S.H., M.L.), Manchester University NHS Foundation Trust, United Kingdom.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Luckie', 'Affiliation': 'Manchester Heart Centre (S.H., M.L.), Manchester University NHS Foundation Trust, United Kingdom.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Roberts', 'Affiliation': 'Centre for Biostatistics (S.A.R.), University of Manchester, United Kingdom.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Glossop', 'Affiliation': ""St Mary's Hospital (L.O., H.G., E.D.J., J.E.M.), Manchester University NHS Foundation Trust, United Kingdom.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Trafford', 'Affiliation': 'Division of Cardiovascular Sciences (A.T.), University of Manchester, United Kingdom.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cottrell', 'Affiliation': 'From the Maternal and Fetal Health Research Centre, Division of Developmental Biology and Medicine (L.O., E.C., E.D.J., J.E.M.), University of Manchester, United Kingdom.'}, {'ForeName': 'Edward D', 'Initials': 'ED', 'LastName': 'Johnstone', 'Affiliation': 'From the Maternal and Fetal Health Research Centre, Division of Developmental Biology and Medicine (L.O., E.C., E.D.J., J.E.M.), University of Manchester, United Kingdom.'}, {'ForeName': 'Jenny E', 'Initials': 'JE', 'LastName': 'Myers', 'Affiliation': 'From the Maternal and Fetal Health Research Centre, Division of Developmental Biology and Medicine (L.O., E.C., E.D.J., J.E.M.), University of Manchester, United Kingdom.'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.15875'] 1487,33020137,"Subacromial decompression versus diagnostic arthroscopy for shoulder impingement: a 5-year follow-up of a randomised, placebo surgery controlled clinical trial.","OBJECTIVES To assess the long-term efficacy of arthroscopic subacromial decompression (ASD) by comparing it with diagnostic arthroscopy (primary comparison), a placebo surgical intervention, and with a non-operative alternative, exercise therapy (secondary comparison). METHODS We conducted a multicentre, three group, randomised, controlled superiority trial. We included 210 patients aged 35-65 years, who had symptoms consistent with shoulder impingement syndrome for more than 3 months. 175 participants (83%) completed the 5 years follow-up. Patient enrolment began on 1 February 2005 and the 5-year follow-up was completed by 10 October 2018. The two primary outcomes were shoulder pain at rest and on arm activity measured with Visual Analogue Scale (VAS). Minimally important difference (MID) was set at 15. We used a mixed-model repeated measurements analysis of variance with participant as a random factor, the baseline value as a covariate and assuming a covariance structure with compound symmetry. RESULTS In the primary intention to treat analysis (ASD vs diagnostic arthroscopy), there were no between-group differences that exceeded the MID for the primary outcomes at 5 years: the mean difference between groups (ASD minus diagnostic arthroscopy) in pain VAS were -2.0 (95% CI -8.5 to 4.6; p=0.56) at rest and -8.0 (-17.3 to 1.3; p=0.093) on arm activity. There were no between-group differences in the secondary outcomes or adverse events that exceeded the MID. In our secondary comparison (ASD vs exercise therapy), the mean differences between groups (ASD minus exercise therapy) in pain VAS were 1.0 (-5.6 to 7.6; p=0.77) at rest and -3.9 (-12.8 to 5.1; p=0.40) on arm activity. There were no significant between-group differences for the secondary outcomes or adverse events. CONCLUSIONS ASD provided no benefit over diagnostic arthroscopy (or exercise therapy) at 5 years for patients with shoulder impingement syndrome.",2021,"In the primary intention to treat analysis (ASD vs diagnostic arthroscopy), there were no between-group differences that exceeded the MID for the primary outcomes at 5 years: the mean difference between groups (ASD minus diagnostic arthroscopy) in pain VAS were -2.0 (95% CI -8.5 to 4.6; p=0.56) at rest and -8.0 (-17.3 to 1.3; p=0.093) on arm activity.","['patients with shoulder impingement syndrome', '210 patients aged 35-65 years, who had symptoms consistent with shoulder impingement syndrome for more than 3 months', 'shoulder impingement', '175 participants (83%) completed the 5 years follow-up', 'Patient enrolment began on 1 February 2005 and the 5-year follow-up was completed by 10 October 2018']","['diagnostic arthroscopy (or exercise therapy', 'Subacromial decompression versus diagnostic arthroscopy', 'placebo', 'placebo surgical intervention, and with a non-operative alternative, exercise therapy (secondary comparison', 'arthroscopic subacromial decompression (ASD']","['adverse events', 'pain VAS', 'shoulder pain at rest and on arm activity measured with Visual Analogue Scale (VAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376685', 'cui_str': 'Impingement syndrome of shoulder region'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C0407864', 'cui_str': 'Diagnostic arthroscopy of joint'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0408159', 'cui_str': 'Anterior decompression of shoulder joint'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",210.0,0.294734,"In the primary intention to treat analysis (ASD vs diagnostic arthroscopy), there were no between-group differences that exceeded the MID for the primary outcomes at 5 years: the mean difference between groups (ASD minus diagnostic arthroscopy) in pain VAS were -2.0 (95% CI -8.5 to 4.6; p=0.56) at rest and -8.0 (-17.3 to 1.3; p=0.093) on arm activity.","[{'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Paavola', 'Affiliation': 'Department of Orthopaedics and Traumatology, Helsinki University Hospital, Helsinki, Finland mika.paavola@hus.fi.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Kanto', 'Affiliation': 'TAYS Hatanpää/Department of Orthopedics and Traumatology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Ranstam', 'Affiliation': 'Mdas AB, Ystad, Sweden.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Malmivaara', 'Affiliation': 'Centre for Health and Social Economics - CHESS, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Jari', 'Initials': 'J', 'LastName': 'Inkinen', 'Affiliation': 'Fysios Finlayson, Tampere, Finland.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Kalske', 'Affiliation': 'Department of Orthopaedics and Traumatology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Vesa', 'Initials': 'V', 'LastName': 'Savolainen', 'Affiliation': 'Department of Orthopaedics and Traumatology, Pohjola Hospital, Helsinki, Finland.'}, {'ForeName': 'Ilkka', 'Initials': 'I', 'LastName': 'Sinisaari', 'Affiliation': 'Terveystalo Healthcare Services, Helsinki, Uusimaa, Finland.'}, {'ForeName': 'Simo', 'Initials': 'S', 'LastName': 'Taimela', 'Affiliation': 'Department of Orthopaedics and Traumatology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Teppo L', 'Initials': 'TL', 'LastName': 'Järvinen', 'Affiliation': 'Department of Orthopaedics and Traumatology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",British journal of sports medicine,['10.1136/bjsports-2020-102216'] 1488,33026570,"Evaluation of the efficacy of masturbation on distal ureteral stones: a prospective, randomized, controlled study.","PURPOSE To evaluate the effect of masturbation on the spontaneous expulsion of distal ureteral stones 5-10 mm in size. MATERIAL AND METHODS A total of 128 men with distal ureteral stones were randomly divided into 3 groups. All patients received standard medical therapy. Patients in group 1 (n = 43) were instructed to masturbate at least 3-4 times a week, patients in group 2 (n = 41) received tamsulosin 0.4 mg/day, and patients in group 3 (controls, n = 44) received standard medical therapy alone. Rates of expulsion, need for analgesic, and ureterorenoscopic lithotripsy were compared between the groups. RESULTS The mean ages of the patients in groups 1, 2, and 3 were 37 ± 5.0, 37.6 ± 4.6, and 38.4 ± 6.8 years, respectively (p = 0.7). The mean stone size in each group was 6.93 ± 1.1 mm, 7.1 ± 0.9 mm, and 6.87 ± 1.1 mm, respectively (p = 0.4). Spontaneous passage rates in groups 1, 2, and 3 were 81.4%, 80.5%, and 43.2%, respectively, and were significantly higher in group 1 (p = 0.001) and group 2 (p = 0.001) when compared with group 3. Analgesic requirement in groups 1, 2, and 3 was 1.7 ± 0.6, 1.5 ± 0.6, and 1.8 ± 0.6 times per day, respectively, and was significantly lower in the tamsulosin group than in the control group (p = 0.004) CONCLUSION: Masturbation and tamsulosin increased the spontaneous passage of distal ureteral stones 5-10 mm in size. Masturbating at least 3-4 times a week was as effective as tamsulosin. Masturbation and tamsulosin also reduced the need for ureterorenoscopic lithotripsy.",2021,Masturbation and tamsulosin increased the spontaneous passage of distal ureteral stones 5-10 mm in size.,"['128 men with distal ureteral stones', 'mean ages of the patients in groups 1, 2, and 3 were 37\u2009±\u20095.0, 37.6\u2009±\u20094.6, and 38.4\u2009±\u20096.8\xa0years, respectively (p\u2009=\u20090.7', 'distal ureteral stones']","['standard medical therapy', 'tamsulosin', 'standard medical therapy alone']","['spontaneous passage of distal ureteral stones', 'Rates of expulsion, need for analgesic, and ureterorenoscopic lithotripsy', 'mean stone size', 'Analgesic requirement', 'spontaneous expulsion of distal ureteral stones', 'Spontaneous passage rates']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517474', 'cui_str': '0.7'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}]","[{'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}, {'cui': 'C1293107', 'cui_str': 'Expulsion'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}]",128.0,0.0334812,Masturbation and tamsulosin increased the spontaneous passage of distal ureteral stones 5-10 mm in size.,"[{'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Turgut', 'Affiliation': 'Faculty of Health Science, Avrasya University, Trabzon, Turkey. drhasanturgut@hotmail.com.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Sarıer', 'Affiliation': 'Department of Urology, Istinye University Medical Faculty, Istanbul, Turkey.'}]",International urology and nephrology,['10.1007/s11255-020-02672-y'] 1489,33023067,Effect of Maternal Docosahexaenoic Acid (DHA) Supplementation on Offspring Neurodevelopment at 12 Months in India: A Randomized Controlled Trial.,"Intake of dietary docosahexaenoic acid (DHA 22:6n-3) is very low among Indian pregnant women. Maternal supplementation during pregnancy and lactation may benefit offspring neurodevelopment. We conducted a double-blind, randomized, placebo-controlled trial to test the effectiveness of supplementing pregnant Indian women (singleton gestation) from ≤20 weeks through 6 months postpartum with 400 mg/d algal DHA compared to placebo on neurodevelopment of their offspring at 12 months. Of 3379 women screened, 1131 were found eligible; 957 were randomized. The primary outcome was infant neurodevelopment at 12 months, assessed using the Development Assessment Scale for Indian Infants (DASII). Both groups were well balanced on sociodemographic variables at baseline. More than 72% of women took >90% of their assigned treatment. Twenty-five serious adverse events (SAEs), none related to the intervention, (DHA group = 16; placebo = 9) were noted. Of 902 live births, 878 were followed up to 12 months; the DASII was administered to 863 infants. At 12 months, the mean development quotient (DQ) scores in the DHA and placebo groups were not statistically significant (96.6 ± 12.2 vs. 97.1 ± 13.0, p = 0.60). Supplementing mothers through pregnancy and lactation with 400 mg/d DHA did not impact offspring neurodevelopment at 12 months of age in this setting.",2020,"At 12 months, the mean development quotient (DQ) scores in the DHA and placebo groups were not statistically significant (96.6 ± 12.2 vs. 97.1 ± 13.0, p = 0.60).","['Indian pregnant women', 'supplementing pregnant Indian women (singleton gestation) from ≤20 weeks through 6 months postpartum with 400 mg', 'Offspring Neurodevelopment at 12 Months in India', '3379 women screened, 1131 were found eligible; 957 were randomized']","['Maternal Docosahexaenoic Acid (DHA) Supplementation', 'd algal DHA', 'placebo', 'Maternal supplementation', 'dietary docosahexaenoic acid (DHA 22:6n-3']","['mean development quotient (DQ) scores', 'infant neurodevelopment at 12 months, assessed using the Development Assessment Scale for Indian Infants (DASII']","[{'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0556102', 'cui_str': 'Docosahexaenoic acid supplementation'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}]",9.0,0.541987,"At 12 months, the mean development quotient (DQ) scores in the DHA and placebo groups were not statistically significant (96.6 ± 12.2 vs. 97.1 ± 13.0, p = 0.60).","[{'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Khandelwal', 'Affiliation': 'Public Health Foundation of India, 47, Sector 44, Institutional area, Gurugram, Haryana 122003, India.'}, {'ForeName': 'Dimple', 'Initials': 'D', 'LastName': 'Kondal', 'Affiliation': 'Public Health Foundation of India, 47, Sector 44, Institutional area, Gurugram, Haryana 122003, India.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Chaudhry', 'Affiliation': 'Public Health Foundation of India, 47, Sector 44, Institutional area, Gurugram, Haryana 122003, India.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Patil', 'Affiliation': ""KAHER's JN Medical College, JNMC KLE University Campus, Nehru Nagar, Belgaum, Karnataka 590010, India.""}, {'ForeName': 'Mallaiah Kenchaveeraiah', 'Initials': 'MK', 'LastName': 'Swamy', 'Affiliation': ""KAHER's JN Medical College, JNMC KLE University Campus, Nehru Nagar, Belgaum, Karnataka 590010, India.""}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Metgud', 'Affiliation': ""KAHER's Institute of Physiotherapy, JNMC KLE University Campus, Nehru Nagar, Belgaum, Karnataka 590010, India.""}, {'ForeName': 'Sandesh', 'Initials': 'S', 'LastName': 'Jogalekar', 'Affiliation': ""KAHER's JN Medical College, JNMC KLE University Campus, Nehru Nagar, Belgaum, Karnataka 590010, India.""}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Kamate', 'Affiliation': ""KAHER's JN Medical College, JNMC KLE University Campus, Nehru Nagar, Belgaum, Karnataka 590010, India.""}, {'ForeName': 'Gauri', 'Initials': 'G', 'LastName': 'Divan', 'Affiliation': 'Sangath, C-1/52, Block C 1, Bhim Nagri, Hauz Khas, New Delhi 110016, India.'}, {'ForeName': 'Ruby', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Public Health Foundation of India, 47, Sector 44, Institutional area, Gurugram, Haryana 122003, India.'}, {'ForeName': 'Dorairaj', 'Initials': 'D', 'LastName': 'Prabhakaran', 'Affiliation': 'Public Health Foundation of India, 47, Sector 44, Institutional area, Gurugram, Haryana 122003, India.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Tandon', 'Affiliation': 'All India Institute of Medical Sciences, Sri Aurobindo Marg, New Delhi 110029, India.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Ramakrishnan', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA 30322, USA.'}, {'ForeName': 'Aryeh D', 'Initials': 'AD', 'LastName': 'Stein', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA 30322, USA.'}]",Nutrients,['10.3390/nu12103041'] 1490,33029804,Single- or double-layer uterine closure techniques following cesarean: A randomized trial.,"INTRODUCTION Cesarean deliveries are commonly performed throughout the world. Although the uterine closure technique following this procedure may influence how the uterine scar heals, there is insufficient evidence for choosing the appropriate technique and so preventing long-term negative consequences. This prospective, randomized study examined the effects of single- and double-layer uterine closure techniques on uterine scar healing following cesarean delivery. MATERIAL AND METHODS This study assessed a total of 282 women aged 18-45 years who were in gestational weeks 24-41 of singleton pregnancies. None had previously undergone uterine surgeries. These participants completed their first cesarean deliveries at the time of study and were randomized into the following two treatment groups: single-layer closure with locking and double-layer closure with locking in the first layer, but not in the second layer (NCT03629028). However, the decidua was not included for treatment in either group. Participants were evaluated at 6-9 months after cesarean section by saline infusion sonohysterography to assess cesarean delivery scar defects. These procedures were conducted by experienced sonographers who were not aware of the uterine closure technique. RESULTS Of the 225 final participants, 109 received the single-layer closure technique, whereas 116 received the double-layer technique. The niche rates were 37% (n = 40) for the single-layer group and 45.7% (n = 53) for the double-layer group (P = .22, relative risk 1.4, 95% CI = 0.8-4.4). CONCLUSIONS The single- and double-layer closure techniques did not produce different impacts on uterine scar niche development.",2021,The single- and double-layer closure techniques did not produce different impacts on uterine scar niche development.,"['Of the 225 final participants', 'cesarean', '282 women aged 18-45 years who were in gestational weeks 24-41 of singleton pregnancies', 'participants completed their first cesarean deliveries at the time of study']","['single- and double-layer uterine closure techniques', 'Single or double-layer uterine closure techniques', 'single-layer closure with locking and double-layer closure with locking']","['uterine-scar healing', 'niche rates', 'cesarean delivery scar defects']","[{'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0426015', 'cui_str': 'Scarring of uterus'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0243067', 'cui_str': 'defects'}]",282.0,0.192183,The single- and double-layer closure techniques did not produce different impacts on uterine scar niche development.,"[{'ForeName': 'Şafak', 'Initials': 'Ş', 'LastName': 'Yılmaz Baran', 'Affiliation': 'Department of Obstetrics and Gynecology, Başkent University Faculty of Medicine, Adana, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Kalaycı', 'Affiliation': 'Department of Obstetrics and Gynecology, Başkent University Faculty of Medicine, Adana, Turkey.'}, {'ForeName': 'Gülşen', 'Initials': 'G', 'LastName': 'Doğan Durdağ', 'Affiliation': 'Department of Obstetrics and Gynecology, Başkent University Faculty of Medicine, Adana, Turkey.'}, {'ForeName': 'Selçuk', 'Initials': 'S', 'LastName': 'Yetkinel', 'Affiliation': 'Department of Obstetrics and Gynecology, Başkent University Faculty of Medicine, Adana, Turkey.'}, {'ForeName': 'Songül', 'Initials': 'S', 'LastName': 'Alemdaroğlu', 'Affiliation': 'Department of Obstetrics and Gynecology, Başkent University Faculty of Medicine, Adana, Turkey.'}, {'ForeName': 'Tayfun', 'Initials': 'T', 'LastName': 'Çok', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology and IVF Unit, Başkent University Faculty of Medicine, Adana, Turkey.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Bulgan Kılıçdağ', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology and IVF Unit, Başkent University Faculty of Medicine, Adana, Turkey.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.14018'] 1491,33029828,A quasi-experimental study into the effects of naps and therapy glasses on fatigue and well-being.,"AIM To investigate the effects of a napping facility and therapy glasses on fatigue and well-being at the end of the night shift. BACKGROUND Night shift work has adverse effects on fatigue and well-being. METHODS A quasi-experimental study was conducted, and data were collected on 243 night shifts of 95 nurses who had either access to a napping facility, therapy glasses, both facilities or no facilities. Multilevel analyses were conducted to predict fatigue and well-being. RESULTS Night shifts of nurses having access to both facilities were associated with less fatigue and more well-being. The use of therapy glasses related negatively to fatigue and positively to well-being. The use of the napping facility was not associated with fatigue and well-being. However, having slept while napping and sleeping time during napping were negatively associated with fatigue and positively associated with well-being. CONCLUSION Therapy glasses and sleeping in a napping facility can be effective interventions in reducing the adverse effects of night shift work. IMPLICATIONS FOR NURSING MANAGEMENT Therapy glasses seem an effective investment to facilitate the well-being of nurses. To enhance sleeping during napping, it is worthwhile to let nurses get accustomed to the napping facility and customize settings to personal preferences.",2021,The use of the napping facility was not associated with fatigue and well-being.,"['A quasi-experimental study was conducted and data was collected on 243 night shifts of 95 nurses who had either access to a napping facility, therapy glasses, both facilities, or no facilities']",['napping facility and therapy glasses'],[],"[{'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}]","[{'cui': 'C0067518', 'cui_str': 'N-(4-aminophenethyl)spiroperidol'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}]",[],,0.0146329,The use of the napping facility was not associated with fatigue and well-being.,"[{'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'van Woerkom', 'Affiliation': 'Department of Human Resource Studies, Tilburg University, Tilburg, The Netherlands.'}]",Journal of nursing management,['10.1111/jonm.13172'] 1492,33037989,Feasibility of a behavioral intervention using mobile health applications to reduce cardiovascular risk factors in cancer survivors: a pilot randomized controlled trial.,"PURPOSE Determine the feasibility of a remotely delivered mobile health (mHealth)-supported intervention to improve diet and physical activity in hematologic malignancy survivors. METHODS Pilot randomized controlled trial of a 16-week intervention for improving diet and physical activity: individualized goal-setting (daily steps, sodium, saturated fat, added sugar intake) per feedback from mHealth trackers (Fitbit for activity; Healthwatch360 for diet), supplemented by a Facebook peer support group. Controls accessed the trackers without goal-setting or peer support. Everyone received standardized survivorship counseling with tailored advice from a clinician. Actigraphy and food frequency questionnaires assessed activity and diet at baseline and follow-up. RESULTS Forty-one participants (51.2% male; median age 45.1 years; 7.0 years from treatment) were randomized (24 intervention; 17 control). Fitbit and Healthwatch360 use were more common among intervention versus control participants (75.0% versus 70.6% and 50.0% versus 17.7% of eligible days, respectively). Most intervention participants (66.7%) engaged with Facebook; overall, 91.7% interacted with the study's mHealth applications. While no comparisons in activity or dietary outcomes between intervention versus control group met statistical significance, the intervention was associated with greater reductions in the targeted dietary factors and improvements in Healthy Eating Index-2015 score, moderate-vigorous physical activity time, and daily steps. Participant retention at 6 months was 90.2%. CONCLUSIONS An intervention for cardiovascular risk reduction based on individualized goal-setting enhanced by mHealth and social media peer support was feasible and acceptable among cancer survivors. IMPLICATIONS FOR CANCER SURVIVORS Effective and easily disseminated strategies that improve diet and physical activity in this population are needed. TRIAL REGISTRATION Registered in ClinicalTrials.gov (NCT03574012) on June 29, 2018.",2020,"Most intervention participants (66.7%) engaged with Facebook; overall, 91.7% interacted with the study's mHealth applications.","['hematologic malignancy survivors', 'cancer survivors', 'Forty-one participants (51.2% male; median age 45.1\xa0years; 7.0\xa0years from treatment']","['standardized survivorship counseling', 'remotely delivered mobile health (mHealth)-supported intervention', 'diet and physical activity: individualized goal-setting (daily steps, sodium, saturated fat, added sugar intake) per feedback from mHealth trackers (Fitbit for activity; Healthwatch360 for diet), supplemented by a Facebook peer support group', 'behavioral intervention using mobile health applications']","['cardiovascular risk factors', 'activity or dietary outcomes', 'Healthy Eating Index-2015 score, moderate-vigorous physical activity time, and daily steps', 'Actigraphy and food frequency questionnaires assessed activity and diet']","[{'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0556234', 'cui_str': 'Sugar intake'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0717649,"Most intervention participants (66.7%) engaged with Facebook; overall, 91.7% interacted with the study's mHealth applications.","[{'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Chow', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA. ericchow@uw.edu.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Doody', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Chongzhi', 'Initials': 'C', 'LastName': 'Di', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Saro H', 'Initials': 'SH', 'LastName': 'Armenian', 'Affiliation': 'City of Hope Medical Center, Duarte, CA, USA.'}, {'ForeName': 'K Scott', 'Initials': 'KS', 'LastName': 'Baker', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'Bricker', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Gopal', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Hagen', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Tyler G', 'Initials': 'TG', 'LastName': 'Ketterl', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Kerryn W', 'Initials': 'KW', 'LastName': 'Reding', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Jeannette M', 'Initials': 'JM', 'LastName': 'Schenk', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Syrjala', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Taylor', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Guangxing', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Neuhouser', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Mendoza', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}]",Journal of cancer survivorship : research and practice,['10.1007/s11764-020-00949-w'] 1493,33036567,Feasibility and efficacy of a supervised home-based physical exercise program for metastatic cancer patients receiving oral targeted therapy: study protocol for the phase II/III - UNICANCER SdS 01 QUALIOR trial.,"BACKGROUND Currently, oral targeted therapies are known to be effective and are frequently used to treat metastatic cancer patients, but fatigue is a frequently reported early side effect of these treatments. This fatigue may impact the patient's treatment adherence and result in a negative impact on quality of life. Physical exercise significantly improved the general well-being and quality of life of advanced cancer patients. However, there is no specific physical activity program adapted for patients with advanced disease. METHODS QUALIOR is a two-part, randomized, open-label, and multicenter with two arms phase II/III trial. Patients (phase II: n = 120; phase III: n = 312) with metastatic cancer (breast cancer, kidney cancer, lung cancer, and other cancers [including but not limited to colon cancer, melanoma, sarcoma, or hepatocarcinoma]) treated with a first- or second-line oral targeted therapy without chemotherapy will be included. Patients will be randomized (2:1) to a 3-month supervised home-based standardized physical activity program or to a recommended adapted physical activity (via a booklet). The primary objective of the phase II is to evaluate the feasibility of the supervised program. The primary objective of the phase III is the evaluation of the benefit of the supervised home-based program compare to the recommended program in terms of fatigue and quality of life at 3 months. The secondary objectives aim to evaluate the impact of the supervised program on fatigue over time, pain, physical capacities, psychosocial and cognitive functions, general quality of life, frequency of dose reduction and patients' adherence to the targeted therapy, overall survival, and progression-free survival. This study will also evaluate the medico-economic impact of supervised program compared to the recommended adapted physical activity program. DISCUSSION The aim of this study is to evaluate home-based physical exercise program for metastatic cancer patients treated with oral targeted therapies to help patients to cope with fatigue and improve quality of life. TRIAL REGISTRATION This trial was registered in ClinicalTrials.gov since May 2017 ( NCT03169075 ).",2020,Physical exercise significantly improved the general well-being and quality of life of advanced cancer patients.,"['metastatic cancer patients receiving oral targeted therapy', 'metastatic cancer patients', 'Patients (phase II: n\u2009=\u2009120; phase III: n\u2009=\u2009312) with metastatic cancer (breast cancer, kidney cancer, lung cancer, and other cancers [including but not limited to colon cancer, melanoma, sarcoma, or hepatocarcinoma]) treated with a', 'advanced cancer patients', 'patients with advanced disease']","['Physical exercise', 'supervised program', 'supervised home-based standardized physical activity program or to a recommended adapted physical activity (via a booklet', 'home-based physical exercise program', 'supervised home-based physical exercise program', 'first- or second-line oral targeted therapy without chemotherapy']","['fatigue and quality of life', 'general well-being and quality of life', 'Feasibility and efficacy', ""fatigue over time, pain, physical capacities, psychosocial and cognitive functions, general quality of life, frequency of dose reduction and patients' adherence to the targeted therapy, overall survival, and progression-free survival"", 'quality of life']","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0740457', 'cui_str': 'Malignant tumor of kidney'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.047477,Physical exercise significantly improved the general well-being and quality of life of advanced cancer patients.,"[{'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Joly', 'Affiliation': 'Centre François Baclesse et CHU Côte de Nacre, Caen, France. f.joly@baclesse.unicancer.fr.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Lefeuvre-Plesse', 'Affiliation': 'Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Garnier-Tixidre', 'Affiliation': 'Institut Daniel Hollard, Grenoble, France.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Helissey', 'Affiliation': 'HIA Begin, Saint Mandé, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Menneveau', 'Affiliation': 'CHRU de Besançon, Besançon, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Zannetti', 'Affiliation': 'CH, Cholet, France.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Salas', 'Affiliation': 'CHU La Timone, Marseille, France.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Houede', 'Affiliation': 'Institut de Cancérologie du Gard, Nîmes, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Abadie-Lacourtoisie', 'Affiliation': 'ICO René Gauducheau, Nantes, France.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Stefani', 'Affiliation': 'CH Annecy Genevois, Pringy, France.'}, {'ForeName': 'Soazig', 'Initials': 'S', 'LastName': 'Nenan', 'Affiliation': 'Unicancer, Paris, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Rieger', 'Affiliation': 'Unicancer, Paris, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Durand-Zaleski', 'Affiliation': ""Hôpital de l'Hôtel-Dieu, Paris, France.""}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Descotes', 'Affiliation': 'CAMI Sport et Cancer, Neuilly sur seine, France.'}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Anota', 'Affiliation': 'CHRU de Besançon, Besançon, France.'}]",BMC cancer,['10.1186/s12885-020-07381-4'] 1494,33036579,Is hypofractionated whole pelvis radiotherapy (WPRT) as well tolerated as conventionally fractionated WPRT in prostate cancer patients? The HOPE trial.,"BACKGROUND Patients with high-risk prostate cancer are at increased risk of lymph node metastasis and are thought to benefit from whole pelvis radiotherapy (WPRT). There has been recent interest in the use of hypofractionated radiotherapy in treating prostate cancer. However, toxicity and cancer outcomes associated with hypofractionated WPRT are unclear at this time. This phase II study aims to investigate the impact in quality of life associated with hypofractionated WPRT compared to conventionally fractionated WPRT. METHODS Fifty-eight patients with unfavourable intermediate-, high- or very high-risk prostate cancer will be randomized in a 1:1 ratio between high-dose-rate brachytherapy (HDR-BT) + conventionally fractionated (45 Gy in 25 fractions) WPRT vs. HDR-BT + hypofractionated (25 Gy in 5 fractions) WPRT. Randomization will be performed with a permuted block design without stratification. The primary endpoint is late bowel toxicity and the secondary endpoints include acute and late urinary and sexual toxicity, acute bowel toxicity, biochemical failure-, androgen deprivation therapy-, metastasis- and prostate cancer-free survival of the hypofractionated arm compared to the conventionally fractionated arm. DISCUSSION To our knowledge, this is the first study to compare hypofractionated WPRT to conventionally fractionated WPRT with HDR-BT boost. Hypofractionated WPRT is a more attractive and convenient treatment approach, and may become the new standard of care if demonstrated to be well-tolerated and effective. TRIAL REGISTRATION This trial was prospectively registered in ClinicalTrials.gov as NCT04197141 on December 12, 2019.",2020,"This phase II study aims to investigate the impact in quality of life associated with hypofractionated WPRT compared to conventionally fractionated WPRT. ","['Patients with high-risk prostate cancer', 'Fifty-eight patients with unfavourable intermediate-, high- or very high-risk prostate cancer', 'prostate cancer patients']","['hypofractionated whole pelvis radiotherapy (WPRT', 'whole pelvis radiotherapy (WPRT', 'hypofractionated WPRT', 'conventionally fractionated WPRT', 'high-dose-rate brachytherapy (HDR-BT)\u2009+\u2009conventionally fractionated (45\u2009Gy in 25 fractions) WPRT vs. HDR-BT\u2009+\u2009hypofractionated (25\u2009Gy in 5 fractions) WPRT', 'Hypofractionated WPRT', 'hypofractionated radiotherapy']","['late bowel toxicity and the secondary endpoints include acute and late urinary and sexual toxicity, acute bowel toxicity, biochemical failure-, androgen deprivation therapy-, metastasis- and prostate cancer-free survival of the hypofractionated arm compared to the conventionally fractionated arm', 'toxicity and cancer outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0442804', 'cui_str': 'Very high'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0454270', 'cui_str': 'High dose rate brachytherapy'}, {'cui': 'C1158513', 'cui_str': 'Recombinational Repair of DNA'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",58.0,0.108763,"This phase II study aims to investigate the impact in quality of life associated with hypofractionated WPRT compared to conventionally fractionated WPRT. ","[{'ForeName': 'Lucas C', 'Initials': 'LC', 'LastName': 'Mendez', 'Affiliation': 'Division of Radiation Oncology, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada. lucascastromendez@gmail.com.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Arifin', 'Affiliation': 'Division of Radiation Oncology, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Glenn S', 'Initials': 'GS', 'LastName': 'Bauman', 'Affiliation': 'Division of Radiation Oncology, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Vikram M', 'Initials': 'VM', 'LastName': 'Velker', 'Affiliation': 'Division of Radiation Oncology, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Belal', 'Initials': 'B', 'LastName': 'Ahmad', 'Affiliation': 'Division of Radiation Oncology, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lock', 'Affiliation': 'Division of Radiation Oncology, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Varagur M', 'Initials': 'VM', 'LastName': 'Venkatesan', 'Affiliation': 'Division of Radiation Oncology, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Sexton', 'Affiliation': 'Division of Radiation Oncology, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'George B', 'Initials': 'GB', 'LastName': 'Rodrigues', 'Affiliation': 'Division of Radiation Oncology, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Physics and Engineering, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Schaly', 'Affiliation': 'Department of Physics and Engineering, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Warner', 'Affiliation': 'Division of Radiation Oncology, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': ""D'Souza"", 'Affiliation': 'Division of Radiation Oncology, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}]",BMC cancer,['10.1186/s12885-020-07490-0'] 1495,33009665,"No ""Wearing-Off Effect"" Seen in Quarterly or Monthly Dosing of Fremanezumab: Subanalysis of a Randomized Long-Term Study.","OBJECTIVE To evaluate whether quarterly or monthly administration of fremanezumab for migraine prevention exhibits a pattern of decreased efficacy toward the end of the dosing interval (wearing-off effect). BACKGROUND The main goals of migraine preventive treatment are to reduce the frequency, severity, and duration of migraine attacks, and migraine-associated disability. Wearing-off refers to the phenomenon whereby clinical symptoms return or worsen before the next dose of a drug is due and has been reported previously with migraine preventive medications. DESIGN AND METHODS This was a long-term, 12-month, multicenter, randomized, double-blind, parallel-group phase 3 study (NCT02638103) that included chronic (CM) and episodic migraine (EM) patients who rolled over from the 12-week phase 3 HALO CM (NCT02621931) and EM trials (NCT02629861), as well as an additional subset of 312 new patients. Patients with CM or EM received fremanezumab either monthly or quarterly. In this post hoc analysis, for selected months, the difference in the average number of migraine days between weeks 1-2 and weeks 3-4, between weeks 1-3 and week 4, and between weeks 1-2 and weeks 11-12 were calculated. RESULTS A total of 1890 patients (CM, 1110; EM, 780) were enrolled. At months 3, 6, 9, and 15, there were no substantial differences in mean weekly migraine days between weeks 1-2 and weeks 3-4 or between weeks 1-3 and week 4 with quarterly or monthly fremanezumab in the CM or EM subgroups. There were no substantial increases in mean weekly migraine days between weeks 1-2 and weeks 11-12 during the first quarter of treatment (months 1-3) or the second quarter of treatment (months 4-6) with quarterly or monthly fremanezumab in the CM or EM subgroups. Across both dosing subgroups in CM and EM patients, the mean weekly number of migraine days decreased substantially (30%-42%) during the first 2 weeks; decreases in weekly migraine days remained steady during the last 2 weeks of the first quarter, with a similar maintenance of response during the second quarter. CONCLUSIONS This analysis of data from a long-term, phase 3 study showed that patients receiving quarterly fremanezumab or monthly fremanezumab did not experience a wearing-off effect toward the end of the dosing interval.",2020,There were no substantial increases in mean weekly migraine days between weeks 1-2 and weeks 11-12 during the first quarter of treatment (months 1-3) or the second quarter of treatment (months 4-6) with quarterly or monthly fremanezumab in the CM or EM subgroups.,"['1890 patients (CM, 1110; EM, 780 ) were enrolled', 'included chronic (CM) and episodic migraine (EM) patients who rolled over from the 12-week Phase 3 HALO CM (NCT02621931) and EM trials (NCT02629861), as well as an additional subset of 312 new patients']","['Fremanezumab', 'fremanezumab']","['mean weekly number of migraine days', 'average number of migraine days', 'mean weekly migraine days']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0543436', 'cui_str': 'Does roll over'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0181278', 'cui_str': 'Halo brace'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C4549503', 'cui_str': 'fremanezumab'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",1890.0,0.0446177,There were no substantial increases in mean weekly migraine days between weeks 1-2 and weeks 11-12 during the first quarter of treatment (months 1-3) or the second quarter of treatment (months 4-6) with quarterly or monthly fremanezumab in the CM or EM subgroups.,"[{'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Blumenfeld', 'Affiliation': 'The Headache Center of Southern California, The Neurology Center, Carlsbad, CA, USA.'}, {'ForeName': 'Darko M', 'Initials': 'DM', 'LastName': 'Stevanovic', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Ortega', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Cohen', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Seminerio', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.'}, {'ForeName': 'Ronghua', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Jiang', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.'}, {'ForeName': 'Stewart J', 'Initials': 'SJ', 'LastName': 'Tepper', 'Affiliation': 'Department of Neurology, Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}]",Headache,['10.1111/head.13994'] 1496,33019950,"The efficacy of 'high in' warning labels, health star and traffic light front-of-package labelling: an online randomised control trial.","OBJECTIVE To examine the impact of front-of-package (FOP) labels on perceived healthfulness, purchasing intentions and understanding of common FOP systems. DESIGN A parallel, open-label design randomised participants to different FOP labelling conditions: 'high in' warning labels (WL), multiple traffic light labelling (TLL), health star ratings (HSR) (all displayed per serving) or control with no interpretive FOP labelling. Participants completed a brief educational session via a smartphone application and two experimental tasks. In Task 1, participants viewed healthy or unhealthy versions of four products and rated healthiness and purchasing intention on a seven-point Likert-type scale. In Task 2, participants ranked three sets of five products from healthiest to least healthy. SETTING Online commercial panel. PARTICIPANTS Canadian residents ≥ 18 years who were involved in household grocery shopping, owned a smartphone and met minimum screen requirements. RESULTS Data from 1997 participants (n 500/condition) were analysed. Task 1: across most product categories, the TLL and HSR increased perceived healthiness of healthier products. All FOP systems decreased perceived healthiness of less healthy products. Similar, albeit dampened, effects were seen regarding purchasing intentions. Task 2: participants performed best in the HSR, followed by the TLL, WL and control conditions. Lower health literacy was associated with higher perceived healthiness and purchasing intentions and poorer ranking task performance across all conditions. CONCLUSIONS All FOP labelling systems, after a brief educational session, improved task performance across a wide spectrum of foods. This effect differed depending on the nutritional quality of the products and the information communicated on labels.Trial Registration: NCT03290118.",2021,"Lower health literacy was associated with higher perceived healthiness and purchasing intentions and poorer ranking task performance across all conditions. ","['1997 participants (n 500/condition', 'Canadian residents ≥ 18 years who were involved in household grocery shopping, owned a smartphone and met minimum screen requirements']","['front-of-package (FOP) labels', 'brief educational session via a smartphone application and two experimental tasks', ""FOP labelling conditions: 'high in' warning labels (WL), multiple traffic light labelling (TLL), health star ratings (HSR) (all displayed per serving) or control with no interpretive FOP labelling""]","['Lower health literacy', 'healthiness and purchasing intentions and poorer ranking task performance', 'task performance']","[{'cui': 'C0730225', 'cui_str': '1997'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0150768', 'cui_str': 'Shopping'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0442664', 'cui_str': 'Traffic light'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",,0.171194,"Lower health literacy was associated with higher perceived healthiness and purchasing intentions and poorer ranking task performance across all conditions. ","[{'ForeName': 'Lana', 'Initials': 'L', 'LastName': 'Vanderlee', 'Affiliation': ""Department of Nutritional Sciences and WHO Collaborating Centre on Nutrition Policy for Chronic Disease Prevention, Faculty of Medicine, University of Toronto, Medical Sciences Building, Room 5368m 1 King's College Circle, Toronto, ON, CanadaM5S 1A8.""}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Franco-Arellano', 'Affiliation': ""Department of Nutritional Sciences and WHO Collaborating Centre on Nutrition Policy for Chronic Disease Prevention, Faculty of Medicine, University of Toronto, Medical Sciences Building, Room 5368m 1 King's College Circle, Toronto, ON, CanadaM5S 1A8.""}, {'ForeName': 'Mavra', 'Initials': 'M', 'LastName': 'Ahmed', 'Affiliation': ""Department of Nutritional Sciences and WHO Collaborating Centre on Nutrition Policy for Chronic Disease Prevention, Faculty of Medicine, University of Toronto, Medical Sciences Building, Room 5368m 1 King's College Circle, Toronto, ON, CanadaM5S 1A8.""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Oh', 'Affiliation': ""Department of Nutritional Sciences and WHO Collaborating Centre on Nutrition Policy for Chronic Disease Prevention, Faculty of Medicine, University of Toronto, Medical Sciences Building, Room 5368m 1 King's College Circle, Toronto, ON, CanadaM5S 1A8.""}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Lou', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': ""L'Abbé"", 'Affiliation': ""Department of Nutritional Sciences and WHO Collaborating Centre on Nutrition Policy for Chronic Disease Prevention, Faculty of Medicine, University of Toronto, Medical Sciences Building, Room 5368m 1 King's College Circle, Toronto, ON, CanadaM5S 1A8.""}]",Public health nutrition,['10.1017/S1368980020003213'] 1497,33019981,No influence of sarcopenia on survival of ovarian cancer patients in a prospective validation study.,"OBJECTIVE Decrease in skeletal muscle index (SMI) during neoadjuvant chemotherapy (NACT) has been associated with worse outcome in patients with advanced ovarian cancer. To validate these findings, we tested if a decrease in SMI was a prognostic factor for a homogenous cohort of patients who received NACT in the randomized phase 3 OVHIPEC-trial. METHODS CT-scans were performed at baseline and after two cycles of neoadjuvant chemotherapy in stage III ovarian cancer patients. The SMI (skeletal muscle area in cm 2 divided by body surface area in m 2 ) was calculated using SliceOMatic software. The difference in SMI between both CT-scans (ΔSMI) was calculated. Cox-regression analyses were performed to analyze the independent effect of a difference in SMI (ΔSMI) on outcome. Log-rank tests were performed to plot recurrence-free (RFS) and overall survival (OS). The mean number of adverse events per patient were compared between groups using t-tests. RESULTS Paired CT-scans were available for 212 out of 245 patients (87%). Thirty-four of 74 patients (58%) in the group with a decrease in ΔSMI and 73 of 138 of the patients (53%) in the group with stable/increase in ΔSMI had died. Median RFS and OS did not differ significantly (p = 0.297 and p = 0.764) between groups. Patients with a decrease in SMI experienced more pre-operative adverse events, and more grade 3-4 adverse events. CONCLUSION Decreased SMI during neoadjuvant chemotherapy was not associated with worse outcome in patients with stage III ovarian cancer included in the OVHIPEC-trial. However, a strong association between decreasing SMI and adverse events was found.",2020,Median RFS and OS did not differ significantly (p = 0.297 and p = 0.764) between groups.,"['stage III ovarian cancer patients', 'patients with advanced ovarian cancer', 'patients with stage III ovarian cancer', 'ovarian cancer patients']","['sarcopenia', 'NACT', 'neoadjuvant chemotherapy (NACT', 'neoadjuvant chemotherapy']","['Median RFS and OS', 'plot recurrence-free (RFS) and overall survival (OS', 'ΔSMI', 'SMI', 'SMI (skeletal muscle area', 'SMI experienced more pre-operative adverse events', 'Decreased SMI', 'SMI and adverse events', 'skeletal muscle index (SMI', 'mean number of adverse events']","[{'cui': 'C0278687', 'cui_str': 'Ovarian cancer stage III'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}]","[{'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0341703', 'cui_str': 'Adult Fanconi syndrome'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",245.0,0.0813561,Median RFS and OS did not differ significantly (p = 0.297 and p = 0.764) between groups.,"[{'ForeName': 'Jorne', 'Initials': 'J', 'LastName': 'Ubachs', 'Affiliation': 'Department of Obstetrics and Gynecology, Maastricht University Medical Centre, Universiteitssingel 40, 6229ER Maastricht, the Netherlands; GROW - School for Oncology and Developmental Biology, Maastricht University, Universiteitssingel 40, 6229ER Maastricht, the Netherlands; Department of Surgery, Maastricht University Medical Centre, Universiteitssingel 40, 6229ER Maastricht, the Netherlands; NUTRIM, school of Nutrition and Translational Research in Metabolism, Maastricht University, Universiteitssingel 40, 6229ER Maastricht, the Netherlands.'}, {'ForeName': 'Simone N', 'Initials': 'SN', 'LastName': 'Koole', 'Affiliation': 'Department of Gynecology, the Netherlands Cancer Institute, Plesmanlaan 121, 1066CX Amsterdam, the Netherlands; Department of Medical Oncology, the Netherlands Cancer Institute, Plesmanlaan 121, 1066CX Amsterdam, the Netherlands.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Lahaye', 'Affiliation': 'Department of Radiology, the Netherlands Cancer Institute, Plesmanlaan 121, 1066CX Amsterdam, the Netherlands.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Fabris', 'Affiliation': 'Department of Radiology, the Netherlands Cancer Institute, Plesmanlaan 121, 1066CX Amsterdam, the Netherlands.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Bruijs', 'Affiliation': 'Department of Gynecology, the Netherlands Cancer Institute, Plesmanlaan 121, 1066CX Amsterdam, the Netherlands.'}, {'ForeName': 'Jules', 'Initials': 'J', 'LastName': 'Schagen van Leeuwen', 'Affiliation': 'Department of Obstetrics & Gynecology, Sint Antonius Hospital, Koekoekslaan 1, 3435CM Nieuwegein, the Netherlands.'}, {'ForeName': 'Henk W R', 'Initials': 'HWR', 'LastName': 'Schreuder', 'Affiliation': 'Department of Gynecological Oncology, UMC Utrecht Cancer Center, Heidelberglaan 100, 3584CX Utrecht, the Netherlands.'}, {'ForeName': 'R H', 'Initials': 'RH', 'LastName': 'Hermans', 'Affiliation': 'Department of Gynecology and Obstetrics, Catharina Hospital, Michelangelolaan 2, 5623 EJ Eindhoven, the Netherlands.'}, {'ForeName': 'I H', 'Initials': 'IH', 'LastName': 'de Hingh', 'Affiliation': 'Department of Surgery, Catharina Hospital, Michelangelolaan 2, 5623 EJ Eindhoven, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van der Velden', 'Affiliation': 'Department of Obstetrics and Gynecology, Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.'}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Arts', 'Affiliation': 'Department of Gynecological Oncology, University Medical Center Groningen, Hanzeplein 1, 9713 GZ Groningen, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Ham', 'Affiliation': 'Department of Gynecological oncology, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA Nijmegen, the Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'van Dam', 'Affiliation': 'Department of Gynecologic Oncology, University Hospital Antwerp, Wilrijkstraat 10, 2650 Antwerp, Belgium.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Vuylsteke', 'Affiliation': 'Department of Medical Oncology, UCLouvain and University of Botswana, CHU Ucl Namur, Belgium.'}, {'ForeName': 'Jacco', 'Initials': 'J', 'LastName': 'Bastings', 'Affiliation': 'Department of Obstetrics and Gynecology, Maastricht University Medical Centre, Universiteitssingel 40, 6229ER Maastricht, the Netherlands.'}, {'ForeName': 'Roy F P M', 'Initials': 'RFPM', 'LastName': 'Kruitwagen', 'Affiliation': 'Department of Obstetrics and Gynecology, Maastricht University Medical Centre, Universiteitssingel 40, 6229ER Maastricht, the Netherlands; GROW - School for Oncology and Developmental Biology, Maastricht University, Universiteitssingel 40, 6229ER Maastricht, the Netherlands.'}, {'ForeName': 'Sandrina', 'Initials': 'S', 'LastName': 'Lambrechts', 'Affiliation': 'Department of Obstetrics and Gynecology, Maastricht University Medical Centre, Universiteitssingel 40, 6229ER Maastricht, the Netherlands; GROW - School for Oncology and Developmental Biology, Maastricht University, Universiteitssingel 40, 6229ER Maastricht, the Netherlands.'}, {'ForeName': 'Steven W M', 'Initials': 'SWM', 'LastName': 'Olde Damink', 'Affiliation': 'Department of Surgery, Maastricht University Medical Centre, Universiteitssingel 40, 6229ER Maastricht, the Netherlands; NUTRIM, school of Nutrition and Translational Research in Metabolism, Maastricht University, Universiteitssingel 40, 6229ER Maastricht, the Netherlands; Department of Visceral- and Transplantation Surgery, RWTH Aachen University, Templergraben 55, 52062 Aachen, Germany.'}, {'ForeName': 'Sander S', 'Initials': 'SS', 'LastName': 'Rensen', 'Affiliation': 'Department of Surgery, Maastricht University Medical Centre, Universiteitssingel 40, 6229ER Maastricht, the Netherlands; NUTRIM, school of Nutrition and Translational Research in Metabolism, Maastricht University, Universiteitssingel 40, 6229ER Maastricht, the Netherlands.'}, {'ForeName': 'Toon', 'Initials': 'T', 'LastName': 'Van Gorp', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Herestraat 49, 3000 Leuven, Belgium.'}, {'ForeName': 'Gabe S', 'Initials': 'GS', 'LastName': 'Sonke', 'Affiliation': 'Department of Medical Oncology, the Netherlands Cancer Institute, Plesmanlaan 121, 1066CX Amsterdam, the Netherlands.'}, {'ForeName': 'Willemien J', 'Initials': 'WJ', 'LastName': 'van Driel', 'Affiliation': 'Department of Gynecology, the Netherlands Cancer Institute, Plesmanlaan 121, 1066CX Amsterdam, the Netherlands. Electronic address: w.v.driel@nki.nl.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.09.042'] 1498,33024268,Treatments after progression to first-line FOLFOXIRI and bevacizumab in metastatic colorectal cancer: a pooled analysis of TRIBE and TRIBE2 studies by GONO.,"BACKGROUND FOLFOXIRI/bevacizumab (bev) is a first-line regimen of proven activity and efficacy in metastatic colorectal cancer. The upfront exposure to three cytotoxics raises concerns about the efficacy of treatments after progression. METHODS We performed a pooled analysis of treatments after progression to upfront FOLFOXIRI/bev in patients enrolled in two randomised Phase 3 studies (TRIBE and TRIBE2) that compared FOLFOXIRI/bev to doublets (FOLFOX or FOLFIRI)/bev. Response rate, progression-free survival (2nd PFS) and overall survival (2nd OS) during treatments after progression were assessed. The RECIST response in first line and the oxaliplatin and irinotecan-free interval (OIFI) were investigated as potential predictors of benefit from FOLFOXIRI ± bev reintroduction. RESULTS Longer 2nd PFS was reported in patients receiving FOLFOXIRI ± bev reintroduction compared to doublets ± bev or other treatments (6.1 versus 4.4 and 3.9 months, respectively, P = 0.013), and seems limited to patients achieving a response during first line (6.9 versus 4.2 and 4.7 months, respectively, P = 0.005) and an OIFI ≥ 4 months (7.2 versus 6.5 and 4.6 months, respectively, P = 0.045). CONCLUSIONS First-line FOLFOXIRI/bev does not impair the administration of effective second-line therapies. First-line response and longer OIFI seem associated with improved response and 2nd PFS from FOLFOXIRI ± bev reintroduction, without impacting 2nd OS.",2021,"First-line response and longer OIFI seem associated with improved response and 2nd PFS from FOLFOXIRI ± bev reintroduction, without impacting 2nd OS.",['metastatic colorectal cancer'],"['oxaliplatin and irinotecan', 'FOLFOXIRI/bev to doublets (FOLFOX or FOLFIRI)/bev', 'bevacizumab']","['Response rate, progression-free survival (2nd PFS) and overall survival (2nd OS']","[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.026285,"First-line response and longer OIFI seem associated with improved response and 2nd PFS from FOLFOXIRI ± bev reintroduction, without impacting 2nd OS.","[{'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Rossini', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Unit of Medical Oncology 1, Department of Clinical and Experimental Oncology, Veneto Institute of Oncology, IOV - IRCSS, Via Gattamelata 64, 35128, Padova, Italy.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Antoniotti', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Santini', 'Affiliation': 'Department of Medical Oncology, Campus Bio-Medico-University of Rome, Via Álvaro del Portillo 200, 00128, Rome, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Tomasello', 'Affiliation': 'Oncology Unit, Oncology Department, ASST of Cremona, Viale Concordia 1, 26100, Cremona, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Ermacora', 'Affiliation': 'Department of Oncology, ASUFC University Hospital, Udine, Via Pozzuolo 330, 33100, Udine, Italy.'}, {'ForeName': 'Marco Maria', 'Initials': 'MM', 'LastName': 'Germani', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Bergamo', 'Affiliation': 'Unit of Medical Oncology 1, Department of Clinical and Experimental Oncology, Veneto Institute of Oncology, IOV - IRCSS, Via Gattamelata 64, 35128, Padova, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Ricci', 'Affiliation': 'Medical Oncology and Laboratory of Translational Oncology, Oncology Department, S. Croce and Carle Teaching Hospital Cuneo, Via Michele Coppino 26, 12100, Cuneo, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Caponnetto', 'Affiliation': 'Department of Radiological Science, Oncology And Pathology, Policlinico Umberto I, ""Sapienza"" University of Rome, Viale del Policlinico 155, 00161, Rome, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Moretto', 'Affiliation': 'Unit of Medical Oncology 2, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zaniboni', 'Affiliation': 'Medical Oncology Unit, Poliambulanza Foundation, Via Bissolati 57, 25124, Brescia, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Pietrantonio', 'Affiliation': 'Medical Oncology Department, Fondazione IRCSS Istituto Nazionale dei Tumori, Via Venezian 1, 20133, Milan, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Buonadonna', 'Affiliation': 'Department of Clinical Oncology, Centro di Riferimento Oncologico (CRO) IRCCS, Via Franco Gallini 2, 33081, Aviano, Italy.'}, {'ForeName': 'Giuliana', 'Initials': 'G', 'LastName': 'Ritorto', 'Affiliation': 'Ssd Colorectal Cancer Unit Dipartimento Di Oncologia, AOU Città della Salute e della Scienza di Torino, Corso Bramante 88, 10126, Turin, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Masi', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Tiziana Pia', 'Initials': 'TP', 'LastName': 'Latiano', 'Affiliation': 'Oncology Unit, IRCCS Casa Sollievo della Sofferenza, Viale Cappuccini 1, 71013, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Rapisardi', 'Affiliation': 'Oncology Unit, ARNAS Garibaldi Catania, Piazza Santa Maria di Gesù 5, 95100, Catania, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cremolini', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy. chiaracremolini@gmail.com.'}]",British journal of cancer,['10.1038/s41416-020-01089-9'] 1499,33024271,Correlative serum biomarker analyses in the phase 2 trial of lenvatinib-plus-everolimus in patients with metastatic renal cell carcinoma.,"BACKGROUND No biomarkers have been established to predict treatment efficacy in renal cell carcinoma (RCC). In an exploratory retrospective analysis of a Phase 2 study, we constructed composite biomarker scores (CBSs) to predict progression-free survival (PFS) and overall survival (OS) in patients with metastatic RCC randomised to receive lenvatinib-plus-everolimus. METHODS Of 40 biomarkers tested, the 5 most strongly associated with PFS (HGF, MIG, IL-18BP, IL-18, ANG-2) or OS (TIMP-1, M-CSF, IL-18BP, ANG-2, VEGF) were used to make a 5-factor PFS-CBS or OS-CBS, respectively. A 2-factor CBS was generated with biomarkers common to PFS-CBS and OS-CBS. Patients were divided into groups accordingly (5-factor-CBS high: 3-5, CBS-low: 0-2; 2-factor-CBS high: 1-2, CBS-low: 0). RESULTS PFS/OS with lenvatinib-plus-everolimus were significantly longer in the 5-factor CBS-high group versus the CBS-low group (P = 0.0022/P < 0.0001, respectively). In the CBS-high group, PFS/OS were significantly longer with lenvatinib-plus-everolimus versus everolimus (P < 0.001/P = 0.0079, respectively); PFS was also significantly longer with lenvatinib-plus-everolimus versus lenvatinib (P = 0.0046). The 5-factor-CBS had a predictive role in PFS and OS after multivariate analysis. Similar trends were observed with the 2-factor-CBS for PFS (i.e., lenvatinib-plus-everolimus versus everolimus). CONCLUSIONS The 5-factor CBS may identify patients with metastatic RCC who would benefit from lenvatinib-plus-everolimus versus everolimus; additional validation is required. CLINICAL TRIAL REGISTRATION The clinical trial registration number is NCT01136733.",2021,"METHODS Of 40 biomarkers tested, the 5 most strongly associated with PFS (HGF, MIG, IL-18BP, IL-18, ANG-2) or OS (TIMP-1, M-CSF, IL-18BP, ANG-2, VEGF) were used to make a 5-factor PFS-CBS or OS-CBS, respectively.","['patients with metastatic RCC randomised to receive', 'patients with metastatic renal cell carcinoma', 'renal cell carcinoma (RCC', 'patients with metastatic RCC']","['lenvatinib-plus-everolimus', 'lenvatinib-plus-everolimus versus everolimus']","['5-factor CBS', 'progression-free survival (PFS) and overall survival (OS', 'PFS (HGF, MIG, IL-18BP, IL-18, ANG-2) or OS (TIMP-1, M-CSF, IL-18BP, ANG-2, VEGF', 'PFS', 'PFS/OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721698', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}]","[{'cui': 'C2986924', 'cui_str': 'lenvatinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0215469', 'cui_str': 'CXCL9 protein, human'}, {'cui': 'C1743775', 'cui_str': 'IL18BP protein, human'}, {'cui': 'C0383327', 'cui_str': 'Interleukin 18'}, {'cui': 'C3849511', 'cui_str': 'ANGPT2 protein, human'}, {'cui': 'C0145947', 'cui_str': 'Tissue inhibitor of metalloproteinases 1'}, {'cui': 'C0079784', 'cui_str': 'Colony-stimulating factor, macrophage'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}]",,0.0592448,"METHODS Of 40 biomarkers tested, the 5 most strongly associated with PFS (HGF, MIG, IL-18BP, IL-18, ANG-2) or OS (TIMP-1, M-CSF, IL-18BP, ANG-2, VEGF) were used to make a 5-factor PFS-CBS or OS-CBS, respectively.","[{'ForeName': 'Chung-Han', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA. leec4@mskcc.org.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Glen', 'Affiliation': 'Medical Oncology, Beatson West of Scotland Cancer Center, Glasgow, UK.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Michaelson', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, MA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'Department of Medical Oncology, Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Yukinori', 'Initials': 'Y', 'LastName': 'Minoshima', 'Affiliation': 'Eisai Co., Ltd, Ibaraki, Japan.'}, {'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Kanekiyo', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Ikezawa', 'Affiliation': 'Eisai, Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Pallavi', 'Initials': 'P', 'LastName': 'Sachdev', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Corina E', 'Initials': 'CE', 'LastName': 'Dutcus', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Funahashi', 'Affiliation': 'Eisai Co., Ltd, Ibaraki, Japan.'}, {'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'Voss', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]",British journal of cancer,['10.1038/s41416-020-01092-0'] 1500,33032824,"Excisional treatment comparison for in situ endocervical adenocarcinoma (EXCISE): A phase 2 pilot randomized controlled trial to compare histopathological margin status, specimen size and fragmentation after loop electrosurgical excision procedure and cold knife cone biopsy.","OBJECTIVE Adenocarcinoma in situ (AIS) of the cervix is a precursor to cervical adenocarcinoma. When AIS is detected by cervical screening an excision biopsy is mandatory to exclude invasion. We aimed to compare margins status, specimen size and fragmentation after loop electrosurgical excision procedure (LEEP) and 'cold knife cone biopsy' (CKC). METHODS The EXCISE Trial was an investigator-initiated, multicenter, open-label, parallel-group, phase 2, randomized study. Patients were enrolled at seven hospitals in Australia and New Zealand. We randomly assigned women aged ≥18 to ≤45 years with screen detected AIS to LEEP or CKC. Co-primary endpoints were margin status, specimen size and fragmentation. Analysis was by intention-to-treat. RESULTS Between August 2, 2017 and September 6, 2019, 40 patients were randomly assigned 2:1 to LEEP or CKC. Margin status was evaluable in 36 cases. The proportion of patients with involved margins did not differ between groups. 25 of 26 LEEP and all 14 CKC biopsies were excised as single specimens (p = 1·00). There were no differences in specimen dimensions. Patients in the CKC group had more post-operative complications (64.3% compared to 15.4% for LEEP p = ·00). There were no differences in grade three complications (p = ·65). CONCLUSIONS LEEP was not associated with a greater likelihood of positive margins, specimen fragmentation or smaller excision compared to CKC when performed according to a standardized protocol. However, the study was not powered to establish non-inferiority of LEEP and a definitive phase 3 trial to compare margin status and rates of treatment failure after LEEP and CKC is warranted.",2020,"CONCLUSIONS LEEP was not associated with a greater likelihood of positive margins, specimen fragmentation or smaller excision compared to CKC when performed according to a standardized protocol.","['women aged ≥18 to ≤45\xa0years with screen detected AIS to LEEP or CKC', '40 patients', 'Patients were enrolled at seven hospitals in Australia and New Zealand', 'situ endocervical adenocarcinoma (EXCISE', 'Between August 2, 2017 and September 6, 2019']","['LEEP', 'LEEP or CKC', 'electrosurgical excision procedure and cold knife cone biopsy', ""loop electrosurgical excision procedure (LEEP) and 'cold knife cone biopsy' (CKC"", 'CKC']","['grade three complications', 'margin status, specimen size and fragmentation', 'Margin status', 'post-operative complications', 'specimen dimensions']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0334276', 'cui_str': 'Adenocarcinoma in situ'}, {'cui': 'C0184930', 'cui_str': 'Loop electrosurgical excision procedure'}, {'cui': 'C0195324', 'cui_str': 'Cone biopsy of cervix'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C1263762', 'cui_str': 'Endocervical adenocarcinoma'}]","[{'cui': 'C0184930', 'cui_str': 'Loop electrosurgical excision procedure'}, {'cui': 'C0195324', 'cui_str': 'Cone biopsy of cervix'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1299482', 'cui_str': 'Specimen size'}, {'cui': 'C0332472', 'cui_str': 'Fragmentation'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",40.0,0.140008,"CONCLUSIONS LEEP was not associated with a greater likelihood of positive margins, specimen fragmentation or smaller excision compared to CKC when performed according to a standardized protocol.","[{'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Cohen', 'Affiliation': 'Division of Obstetrics and Gynaecology, University of Western Australia, Crawley, Western Australia, Australia; Dept of Gynaecological Oncology, St John of God Hospital, Subiaco, Western Australia, Australia; Dept of Gynaecological Oncology, King Edward Memorial Hospital, Subiaco, Western Australia, Australia; Institute for Health Research, University of Notre Dame Australia, Fremantle, Western Australia, Australia; Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia. Electronic address: paul.cohen@uwa.edu.au.'}, {'ForeName': 'Yee', 'Initials': 'Y', 'LastName': 'Leung', 'Affiliation': 'Division of Obstetrics and Gynaecology, University of Western Australia, Crawley, Western Australia, Australia; Dept of Gynaecological Oncology, King Edward Memorial Hospital, Subiaco, Western Australia, Australia; Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Lyndal', 'Initials': 'L', 'LastName': 'Anderson', 'Affiliation': 'Sydney Medical School, The University of Sydney, New South Wales, Australia; School of Medicine, Western Sydney University, Penrith South, New South Wales, Australia; Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'van der Griend', 'Affiliation': 'Department of Anatomical Pathology, Canterbury Health Laboratories, Christchurch, New Zealand.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Chivers', 'Affiliation': 'Institute for Health Research, University of Notre Dame Australia, Fremantle, Western Australia, Australia; Exercise Medicine Research Institute, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Sanela', 'Initials': 'S', 'LastName': 'Bilic', 'Affiliation': 'Dept of Gynaecological Oncology, St John of God Hospital, Subiaco, Western Australia, Australia; Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Bittinger', 'Affiliation': ""Oncology and Dysplasia Unit, The Royal Women's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Brand', 'Affiliation': 'Department of Gynaecological Oncology, Westmead Hospital, Sydney, New South Wales, Australia; Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia; Discipline of Obstetrics and Gynaecology, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Max K', 'Initials': 'MK', 'LastName': 'Bulsara', 'Affiliation': 'Institute for Health Research, University of Notre Dame Australia, Fremantle, Western Australia, Australia.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Codde', 'Affiliation': 'Institute for Health Research, University of Notre Dame Australia, Fremantle, Western Australia, Australia; Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Lois', 'Initials': 'L', 'LastName': 'Eva', 'Affiliation': ""Dept of Gynaecological Oncology, National Women's Health, Auckland City Hospital, Auckland, New Zealand; Department of Gynaecological Oncology, University of Auckland, Auckland, New Zealand; Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Farrell', 'Affiliation': 'Dept of Gynaecological Oncology, King Edward Memorial Hospital, Subiaco, Western Australia, Australia.'}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'Harker', 'Affiliation': 'Department of Obstetrics and Gynaecology, Univeristy of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Unine', 'Initials': 'U', 'LastName': 'Herbst', 'Affiliation': 'Department of Gynaecological Oncology, Westmead Hospital, Sydney, New South Wales, Australia; Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Jeffares', 'Affiliation': 'Dept of Gynaecological Oncology, St John of God Hospital, Subiaco, Western Australia, Australia; Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Loh', 'Affiliation': 'Division of Obstetrics and Gynaecology, University of Western Australia, Crawley, Western Australia, Australia; Dept of Gynaecological Oncology, King Edward Memorial Hospital, Subiaco, Western Australia, Australia.'}, {'ForeName': 'Orla', 'Initials': 'O', 'LastName': 'McNally', 'Affiliation': ""Oncology and Dysplasia Unit, The Royal Women's Hospital, Melbourne, Victoria, Australia; Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia; Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Victoria, Australia.""}, {'ForeName': 'Ganendra Raj', 'Initials': 'GR', 'LastName': 'Mohan', 'Affiliation': 'Dept of Gynaecological Oncology, St John of God Hospital, Subiaco, Western Australia, Australia; Dept of Gynaecological Oncology, King Edward Memorial Hospital, Subiaco, Western Australia, Australia; Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Tarryn', 'Initials': 'T', 'LastName': 'Nicholson', 'Affiliation': ""Dept of Gynaecological Oncology, National Women's Health, Auckland City Hospital, Auckland, New Zealand.""}, {'ForeName': 'Aime', 'Initials': 'A', 'LastName': 'Powell', 'Affiliation': 'Institute for Health Research, University of Notre Dame Australia, Fremantle, Western Australia, Australia; Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Stuart G', 'Initials': 'SG', 'LastName': 'Salfinger', 'Affiliation': 'Dept of Gynaecological Oncology, St John of God Hospital, Subiaco, Western Australia, Australia; Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Simcock', 'Affiliation': 'Department of Obstetrics and Gynaecology, Univeristy of Otago, Christchurch, New Zealand; Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia; Christchurch Womens Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Stewart', 'Affiliation': 'Division of Obstetrics and Gynaecology, University of Western Australia, Crawley, Western Australia, Australia; PathWest, King Edward Memorial Hospital, Subiaco, Western Australia, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Silvers', 'Affiliation': ""Oncology and Dysplasia Unit, The Royal Women's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Stockler', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Camperdown, New South Wales, Australia; Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sykes', 'Affiliation': 'Department of Obstetrics and Gynaecology, Univeristy of Otago, Christchurch, New Zealand; Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia; Christchurch Womens Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Pennie', 'Initials': 'P', 'LastName': 'Stoyles', 'Affiliation': 'Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Adeline', 'Initials': 'A', 'LastName': 'Tan', 'Affiliation': 'Clinipath Pathology, Osborne Park, Western Australia, Australia.'}, {'ForeName': 'Ai Ling', 'Initials': 'AL', 'LastName': 'Tan', 'Affiliation': ""Dept of Gynaecological Oncology, National Women's Health, Auckland City Hospital, Auckland, New Zealand; Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia.""}, {'ForeName': 'C David H', 'Initials': 'CDH', 'LastName': 'Wrede', 'Affiliation': ""Oncology and Dysplasia Unit, The Royal Women's Hospital, Melbourne, Victoria, Australia; Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia; Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Victoria, Australia.""}]",Gynecologic oncology,['10.1016/j.ygyno.2020.09.053'] 1501,33038062,"Efficacy and Safety of E6011, an Anti-Fractalkine Monoclonal Antibody, in Patients With Active Rheumatoid Arthritis With Inadequate Response to Methotrexate: Results of a Randomized, Double-Blind, Placebo-Controlled Phase II Study.","OBJECTIVE To evaluate the efficacy and safety of E6011, a humanized IgG2 monoclonal antibody against human fractalkine (FKN), in a phase II, double-blind, placebo-controlled study in rheumatoid arthritis (RA) patients. METHODS Patients with moderate-to-severe RA who had an inadequate response to methotrexate were randomly assigned to a placebo group or to E6011 100-mg, 200-mg, or 400/200-mg groups at a 2:1:2:2 ratio. During the 24-week period, patients received the study drug subcutaneously at weeks 0, 1, and 2 and then once every 2 weeks. The primary end point was the American College of Rheumatology 20% improvement criteria (ACR20) response rate at week 12. RESULTS Study drugs were administered to 190 patients (placebo, n = 54; E6011 100 mg, n = 28; E6011 200 mg, n = 54; E6011 400/200 mg, n = 54), and 169 patients completed treatment. A significant difference from placebo was not found in ACR20 response rates at week 12 (37.0% [placebo], 39.3% [100 mg], 48.1% [200 mg], and 46.3% [400/200 mg], using nonresponder imputation). As a secondary end point, ACR20 response rate in the 200-mg and 400/200-mg groups attained statistical significance at week 24 (35.2% [placebo], 39.3% [100 mg], 53.7% [200 mg], and 57.4% [400/200 mg]). Subsequent exploratory subgroup analysis revealed greater efficacy of E6011, particularly in patients with a higher baseline proportion of CD16+ monocytes; ACR20 response rates in this patient subgroup at week 24 were 30.0% (placebo), 46.7% (100 mg), 57.7% (200 mg), and 69.6% (400/200 mg). E6011 administered for 24 weeks was well tolerated. CONCLUSION This is the first evidence that E6011, a novel cell trafficking inhibitor targeting the FKN-CX 3 CR1 interaction, is modestly effective with 24 weeks of treatment in RA patients, although the primary end point was not met.",2021,"As a secondary endpoint, ACR20 response in the 200-mg and 400/200-mg groups attained statistical significance at week 24 (35.2%, 39.3%, 53.7%, and 57.4%, respectively).","['rheumatoid arthritis (RA) patients', '169 patients completed treatment', 'Patients with moderate to severe RA with inadequate response to', 'Active Rheumatoid Arthritis Patients with Inadequate Response to', '190 patients (54']","['methotrexate (MTX', 'humanized IgG2 monoclonal antibody against human fractalkine (FKN', 'Methotrexate', 'placebo', 'Placebo']","['American College of Rheumatology (ACR)20 response', 'ACR20 response', 'tolerated']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C4517622', 'cui_str': '190'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0020856', 'cui_str': 'Immunoglobulin IgG2'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0535298', 'cui_str': 'Fractalkine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}]",190.0,0.476423,"As a secondary endpoint, ACR20 response in the 200-mg and 400/200-mg groups attained statistical significance at week 24 (35.2%, 39.3%, 53.7%, and 57.4%, respectively).","[{'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Yamanaka', 'Affiliation': 'Sanno Medical Center, Tokyo, Japan.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Nanki', 'Affiliation': 'Toho University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hisanori', 'Initials': 'H', 'LastName': 'Umehara', 'Affiliation': 'Nagahama City Hospital, Shiga, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Yasuda', 'Affiliation': 'KAN Research Institute, Inc, Kobe, Japan.'}, {'ForeName': 'Fumitoshi', 'Initials': 'F', 'LastName': 'Tago', 'Affiliation': 'Eisai Company, Ltd, Tokyo, Japan.'}, {'ForeName': 'Yasumi', 'Initials': 'Y', 'LastName': 'Kitahara', 'Affiliation': 'Eisai Company, Ltd, Tokyo, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Kawakubo', 'Affiliation': 'Eisai Company, Ltd, Tokyo, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Torii', 'Affiliation': 'Eisai Company, Ltd, Tokyo, Japan.'}, {'ForeName': 'Seiichiro', 'Initials': 'S', 'LastName': 'Hojo', 'Affiliation': 'Eisai Company, Ltd, Tokyo, Japan.'}, {'ForeName': 'Tetsu', 'Initials': 'T', 'LastName': 'Kawano', 'Affiliation': 'KAN Research Institute, Inc, Kobe, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Imai', 'Affiliation': 'KAN Research Institute, Inc, Kobe, Japan.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41555'] 1502,33044435,Increased Duration of Exercise Decreases Rate of Nonresponse to Exercise but May Not Decrease Risk for Cancer Mortality.,"INTRODUCTION Previous studies have observed an inverse relationship between exercise and breast cancer risk. However, there is interindividual variability in response to exercise training interventions. We investigated whether increasing the dose of aerobic exercise (150 or 300 min·wk-1), while keeping intensity of exercise constant (70%-80% HRmax), decreases the number of exercise nonresponders and further decreases associated risk for cancer mortality in our study population of women genetically predisposed for breast cancer. METHODS Healthy premenopausal women at elevated risk of breast cancer were randomized into control (<75 min·wk-1, n = 47), low-dose exercise (150 min·wk-1, n = 39), and high-dose exercise groups (300 min·wk-1, n = 39) for approximately 6 months. We assessed 1) clinical effectiveness (CE), defined as an improvement in predicted V˙O2max of ≥1 mL·kg-1·min-1, and twice the typical error (2× TE) of V˙O2max as thresholds to classify exercise ""nonresponders""; 2) CE and 2× TE relative to exercise adherence levels; and 3) related changes in V˙O2max to predicted cancer mortality risk. RESULTS After our 6-month intervention, we observed that 23.5% of women in the low-dose group and 5.6% of women in the high-dose group were clinical nonresponders (P = 0.04). Clinical nonresponder status was independent of adherence level. Associated reduction in risk for cancer mortality was observed among 87.2% of women in the low-dose group and 94.9% in the high-dose group (P = 0.43). CONCLUSION Increasing volume (not intensity) of exercise via time spent exercising significantly decreases the number of ""nonresponders."" True nonresponders were observed as some women did not improve their fitness capacity despite high exercise adherence levels. Lastly, it appears 150 min·wk-1 is sufficient to decrease the predicted risk of cancer mortality.",2021,"Increasing volume (not intensity) of exercise via time spent exercising significantly decreases the number of ""non-responders"".",['Healthy premenopausal women at elevated risk of breast cancer'],"['low-dose exercise', 'aerobic exercise (150 min·week or 300 min·week), while keeping intensity of exercise constant (70%-80% HRmax', 'Exercise']","['predicted VO2max of ≥1 mL·kg·min, and, twice the typical error (2x TE) of VO2max, as thresholds to classify exercise ""non-responders""; 2) CE and 2x TE relative to exercise adherence levels, and 3) related changes in VO2max to predicted cancer mortality risk', 'clinical effectiveness (CE', 'risk of cancer mortality', 'risk for cancer mortality', 'Cancer Mortality']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1720529', 'cui_str': 'Constant'}]","[{'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}]",,0.0490609,"Increasing volume (not intensity) of exercise via time spent exercising significantly decreases the number of ""non-responders"".","[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Lin', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State University College of Medicine, Hershey, PA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Potiaumpai', 'Affiliation': ''}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Schmitz', 'Affiliation': ''}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Sturgeon', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002539'] 1503,33044437,Carbohydrate Supplementation and the Influence of Breakfast on Fuel Use in Hypoxia.,"PURPOSE This study investigated the effect of carbohydrate supplementation on substrate oxidation during exercise in hypoxia after preexercise breakfast consumption and omission. METHODS Eleven men walked in normobaric hypoxia (FiO2 ~11.7%) for 90 min at 50% of hypoxic V˙O2max. Participants were supplemented with a carbohydrate beverage (1.2 g·min-1 glucose) and a placebo beverage (both enriched with U-13C6 D-glucose) after breakfast consumption and after omission. Indirect calorimetry and isotope ratio mass spectrometry were used to calculate carbohydrate (exogenous and endogenous [muscle and liver]) and fat oxidation. RESULTS In the first 60 min of exercise, there was no significant change in relative substrate oxidation in the carbohydrate compared with placebo trial after breakfast consumption or omission (both P = 0.99). In the last 30 min of exercise, increased relative carbohydrate oxidation occurred in the carbohydrate compared with placebo trial after breakfast omission (44.0 ± 8.8 vs 28.0 ± 12.3, P < 0.01) but not consumption (51.7 ± 12.3 vs 44.2 ± 10.4, P = 0.38). In the same period, a reduction in relative liver (but not muscle) glucose oxidation was observed in the carbohydrate compared with placebo trials after breakfast consumption (liver, 7.7% ± 1.6% vs 14.8% ± 2.3%, P < 0.01; muscle, 25.4% ± 9.4% vs 29.4% ± 11.1%, P = 0.99) and omission (liver, 3.8% ± 0.8% vs 8.7% ± 2.8%, P < 0.01; muscle, 19.4% ± 7.5% vs 19.2% ± 12.2%, P = 0.99). No significant difference in relative exogenous carbohydrate oxidation was observed between breakfast consumption and omission trials (P = 0.14). CONCLUSION In acute normobaric hypoxia, carbohydrate supplementation increased relative carbohydrate oxidation during exercise (>60 min) after breakfast omission, but not consumption.",2021,"No significant difference in relative exogenous carbohydrate oxidation was observed between breakfast consumption and omission trials (p = 0.14). ",['Eleven men walked in normobaric hypoxia (FiO2 ~11.7%) for 90-min at 50% of hypoxic V[Combining'],"['Carbohydrate Supplementation', 'carbohydrate beverage (1.2g·min glucose) and a placebo beverage (both enriched with U-C6 D-glucose', 'placebo', 'carbohydrate supplementation']","['muscle) glucose oxidation', 'relative exogenous carbohydrate oxidation', 'substrate oxidation', 'relative substrate oxidation', 'relative carbohydrate oxidation', 'carbohydrate (exogenous and endogenous (muscle and liver)) and fat oxidation', 'relative liver']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0556103', 'cui_str': 'Carbohydrate supplementation'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]",11.0,0.145843,"No significant difference in relative exogenous carbohydrate oxidation was observed between breakfast consumption and omission trials (p = 0.14). ","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Griffiths', 'Affiliation': 'Carnegie School of Sport, Leeds Beckett University, Leeds, UNITED KINGDOM.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Deighton', 'Affiliation': 'Carnegie School of Sport, Leeds Beckett University, Leeds, UNITED KINGDOM.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Boos', 'Affiliation': ''}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Rowe', 'Affiliation': 'Carnegie School of Sport, Leeds Beckett University, Leeds, UNITED KINGDOM.'}, {'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Morrison', 'Affiliation': 'Stable Isotope Biochemistry Laboratory, SUERC, University of Glasgow. East Kilbride, Scotland, UNITED KINGDOM.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Preston', 'Affiliation': 'Stable Isotope Biochemistry Laboratory, SUERC, University of Glasgow. East Kilbride, Scotland, UNITED KINGDOM.'}, {'ForeName': 'Roderick', 'Initials': 'R', 'LastName': 'King', 'Affiliation': 'Carnegie School of Sport, Leeds Beckett University, Leeds, UNITED KINGDOM.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': ""O'Hara"", 'Affiliation': 'Carnegie School of Sport, Leeds Beckett University, Leeds, UNITED KINGDOM.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002536'] 1504,33040465,Effects of vitamin D and calcium supplementation on bone mineral density among Thai youth using daily HIV pre-exposure prophylaxis.,"INTRODUCTION Tenofovir disoproxil fumarate with emtricitabine (TDF/FTC) is used for HIV pre-exposure prophylaxis (PrEP). TDF may affect bone mineral density (BMD), particularly in youth who are at a stage of peak bone mass accrual. The objective of this study was to evaluate the effect of vitamin D and calcium supplementation on BMD among Thai youth receiving daily oral PrEP. METHODS This open-label randomized trial was conducted in male youth aged between 15 and 24 years. Participants were randomized to Arm A who received once-daily TDF/FTC plus vitamin D3 and calcium supplementation with meals twice daily (400 units of vitamin D3 and 1200 mg of elemental calcium/day) or Arm B who received once-daily TDF/FTC only. PrEP users were defined as taking at least two tablets/week (tenofovir-diphosphate level of >350 fmol/punch). Adherence to vitamin D/calcium supplementation was defined as self-reported adherence of >50%. Lumbar spine (L2-L4) BMD (LSBMD) was evaluated by dual-energy X-ray absorptiometry scan zero and six months after PrEP initiation. RESULTS From March 2019 to March 2020, 100 youth were enrolled. Baseline characteristics between the two arms were similar. Median (IQR) age was 18 (17 to 20) years. At entry, median (IQR) LSBMD z-score was -0.8 (-1.5 to -0.3), 17% had low LSBMD (Z-score < -2). The median amount of calcium intake from nutritional three-day recall was 167 (IQR 94 to 272) mg/day, 39% of participants had vitamin D deficiency, defined as 25(OH)D levels <20 IU/mL. At six months, 79 participants were evaluated. Of these, 42 (52%) were PrEP takers and 25 of 38 (66%) of arm A participants had good adherence to vitamin D/calcium supplementation. Significantly higher proportions of youth in arm A compared to arm B had >3% increase in LSBMD at month 6 compared to baseline (67.6% vs. 42.9% respectively; p = 0.03). There were significantly higher increases in LSBMD among youth with vitamin D deficiency who were supplemented; arm A + 0.05 (0 to 0.05) compared to arm B + 0.03 (-0.1 to 0.03), p = 0.04. CONCLUSIONS Increases in LSBMD over six months among youth using PrEP who received vitamin D/calcium supplementation was greater than those not supplemented. Long-term follow-up should be considered to explore long-term outcomes.",2020,Significantly higher proportions of youth in arm A compared to arm B had >3% increase in LSBMD at month 6 compared to baseline (67.6% vs. 42.9% respectively; p = 0.03).,"['male youth aged between 15 and 24\xa0years', 'From March 2019 to March 2020, 100 youth were enrolled', 'Thai youth receiving daily oral PrEP', 'Thai youth using daily HIV pre-exposure prophylaxis', '79 participants were evaluated']","['vitamin D and calcium supplementation', 'vitamin D/calcium supplementation', 'TDF', 'Tenofovir disoproxil fumarate with emtricitabine (TDF/FTC', 'TDF/FTC plus vitamin D3 and calcium supplementation with meals twice daily (400 units of vitamin D3 and 1200\xa0mg of elemental calcium/day) or Arm B who received once-daily TDF/FTC only']","['bone mineral density', 'bone mineral density (BMD', '25(OH)D levels', 'median amount of calcium intake', 'median (IQR) LSBMD z-score', 'LSBMD', 'Lumbar spine (L2-L4) BMD (LSBMD']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C1096319', 'cui_str': 'Prophylaxis against HIV infection'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0206682', 'cui_str': 'Follicular thyroid carcinoma'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4553624', 'cui_str': 'With meals'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}]",79.0,0.215788,Significantly higher proportions of youth in arm A compared to arm B had >3% increase in LSBMD at month 6 compared to baseline (67.6% vs. 42.9% respectively; p = 0.03).,"[{'ForeName': 'Krittaporn', 'Initials': 'K', 'LastName': 'Pornpaisalsakul', 'Affiliation': 'Department of Paediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Wipaporn Natalie', 'Initials': 'WN', 'LastName': 'Songtaweesin', 'Affiliation': 'Center of Excellence for Paediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Supatporn', 'Initials': 'S', 'LastName': 'Tepmongkol', 'Affiliation': 'Department of Radiology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Prissana', 'Initials': 'P', 'LastName': 'Wongharn', 'Affiliation': 'Center of Excellence for Paediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Surinda', 'Initials': 'S', 'LastName': 'Kawichai', 'Affiliation': 'Center of Excellence for Paediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Vichit', 'Initials': 'V', 'LastName': 'Suponsilchai', 'Affiliation': 'Department of Paediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Suvaporn', 'Initials': 'S', 'LastName': 'Anugulruengkitt', 'Affiliation': 'Department of Paediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Thanyawee', 'Initials': 'T', 'LastName': 'Puthanakit', 'Affiliation': 'Department of Paediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the International AIDS Society,['10.1002/jia2.25624'] 1505,33009991,Can Interventions that Strengthen Couples' Relationships Confer Additional Benefits for their Health? A Randomized Controlled Trial with African American Couples.,"This study examined the effects of the Protecting Strong African American Families (ProSAAF) prevention program on adults' self-reported health outcomes 25 months after enrollment. ProSAAF is a couple-focused prevention program specifically designed to meet the needs of African-American families residing in the rural South. African-American couples (N = 346) with an early adolescent child participated in a randomized controlled trial of the program. Dyadic data analyses indicated significant direct effects on changes in couple functioning post-intervention as well as significant indirect effects of ProSAAF on changes in health through post-intervention improvements in couple functioning. These benefits were documented for men's and women's general health, depressive symptoms, and problematic sleep. There were no significant direct effects of ProSAAF participation on changes in health. Findings provide tempered optimism regarding the potential benefits of couple-focused programming for adults' physical, mental, and behavioral health.",2021,Dyadic data analyses indicated significant direct effects on changes in couple functioning post-intervention as well as significant indirect effects of ProSAAF on changes in health through post-intervention improvements in couple functioning.,"['African-American couples (N\u2009=\u2009346) with an early adolescent child participated', 'African American Couples', 'African-American families residing in the rural South']","['Protecting Strong African American Families (ProSAAF) prevention program', 'ProSAAF']",[],"[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],346.0,0.0398157,Dyadic data analyses indicated significant direct effects on changes in couple functioning post-intervention as well as significant indirect effects of ProSAAF on changes in health through post-intervention improvements in couple functioning.,"[{'ForeName': 'Allen W', 'Initials': 'AW', 'LastName': 'Barton', 'Affiliation': 'Department of Human Development and Family Studies, University of Illinois at Urbana-Champaign, 2024 Christopher Hall, MC-081, 904 W. Nevada St., Urbana, IL, 61801, USA. awbarton@illinois.edu.'}, {'ForeName': 'Justin A', 'Initials': 'JA', 'LastName': 'Lavner', 'Affiliation': 'Department of Psychology, University of Georgia, Athens, GA, USA.'}, {'ForeName': 'Steven R H', 'Initials': 'SRH', 'LastName': 'Beach', 'Affiliation': 'Department of Psychology, University of Georgia, Athens, GA, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01175-7'] 1506,33010242,"Safety and immunogenicity of two heterologous HIV vaccine regimens in healthy, HIV-uninfected adults (TRAVERSE): a randomised, parallel-group, placebo-controlled, double-blind, phase 1/2a study.","BACKGROUND Bioinformatically designed mosaic antigens increase the breadth of HIV vaccine-elicited immunity. This study compared the safety, tolerability, and immunogenicity of a newly developed, tetravalent Ad26 vaccine with the previously tested trivalent formulation. METHODS This randomised, parallel-group, placebo-controlled, double-blind, phase 1/2a study (TRAVERSE) was done at 11 centres in the USA and one centre in Rwanda. Eligible participants were adults aged 18 to 50 years, who were HIV-uninfected, healthy at screening based on their medical history and a physical examination including laboratory assessment and vital sign measurements, and at low risk of HIV infection in the opinion of study staff, who applied a uniform definition of low-risk guidelines that was aligned across sites. Enrolled participants were randomly assigned at a 2:1 ratio to tetravalent and trivalent groups. Participants in tetravalent and trivalent groups were then further randomly assigned at a 5:1 ratio to adenovirus 26 (Ad26)-vectored vaccine and placebo subgroups. Randomisation was stratified by region (USA and Rwanda) and based on a computer-generated schedule using randomly permuted blocks prepared under the sponsor's supervision. We masked participants and investigators to treatment allocation throughout the study. On day 0, participants received a first injection of tetravalent vaccine (Ad26.Mos4.HIV or placebo) or trivalent vaccine (Ad26.Mos.HIV or placebo), and those injections were repeated 12 weeks later. At week 24, vaccine groups received a third dose of tetravalent or trivalent together with clade C gp140, and this was repeated at week 48, with placebos again administered to the placebo group. All study vaccines and placebo were administered by intramuscular injection in the deltoid muscle. We assessed adverse events in all participants who received at least one study injection (full analysis set) and Env-specific binding antibodies in all participants who received at least the first three vaccinations according to the protocol-specified vaccination schedule, had at least one measured post-dose blood sample collected, and were not diagnosed with HIV during the study (per-protocol set). This study is registered with Clinicaltrials.gov, NCT02788045. FINDINGS Of 201 participants who were enrolled and randomly assigned, 198 received the first vaccination: 110 were in the tetravalent group, 55 in the trivalent group, and 33 in the placebo group. Overall, 185 (93%) completed two scheduled vaccinations per protocol, 180 (91%) completed three, and 164 (83%) completed four. Solicited, self-limiting local, systemic reactogenicity and unsolicited adverse events were similar in vaccine groups and higher than in placebo groups. All participants in the per-protocol set developed clade C Env binding antibodies after the second vaccination, with higher total IgG titres after the tetravalent vaccine than after the trivalent vaccine (10 413 EU/mL, 95% CI 7284-14 886 in the tetravalent group compared with 5494 EU/mL, 3759-8029 in the trivalent group). Titres further increased after the third and fourth vaccinations, persisting at least through week 72. Other immune responses were also higher with the tetravalent vaccine, including the magnitude and breadth of binding antibodies against a cross-clade panel of Env antigens, and the magnitude of IFNγ ELISPOT responses (median 521 SFU/10 6 peripheral blood mononuclear cells [PBMCs] in the tetravalent group and median 282 SFU/10 6 PBMCs in the trivalent group after the fourth vaccination) and Env-specific CD4+ T-cell response rates after the third and fourth vaccinations. No interference by pre-existing Ad26 immunity was identified. INTERPRETATION The tetravalent vaccine regimen was generally safe, well-tolerated, and found to elicit higher immune responses than the trivalent regimen. Regimens that use this tetravalent vaccine component are being advanced into field trials to assess efficacy against HIV-1 infection. FUNDING National Institutes of Health, Henry M Jackson Foundation for Advancement of Military Medicine and the US Department of Defense, Ragon Institute of MGH, MIT, & Harvard, Bill & Melinda Gates Foundation, and Janssen Vaccines & Prevention.",2020,"Solicited, self-limiting local, systemic reactogenicity and unsolicited adverse events were similar in vaccine groups and higher than in placebo groups.","['Eligible participants were adults aged 18 to 50 years, who were HIV-uninfected, healthy at screening based on their medical history and a physical examination including laboratory assessment and vital sign measurements, and at low risk of HIV infection in the opinion of study staff, who applied a uniform definition of low-risk guidelines that was aligned across sites', '11 centres in the USA and one centre in Rwanda', 'healthy, HIV-uninfected adults (TRAVERSE', '201 participants who were enrolled and randomly assigned']","['HIV or placebo', 'tetravalent vaccine (Ad26.Mos4.HIV or placebo) or trivalent vaccine (Ad26.Mos', 'heterologous HIV vaccine regimens', 'placebos again administered to the placebo', 'placebo', 'adenovirus 26 (Ad26)-vectored vaccine and placebo']","['clade C Env binding antibodies', 'total IgG titres', 'Solicited, self-limiting local, systemic reactogenicity and unsolicited adverse events', 'Safety and immunogenicity', 'adverse events', 'IFNγ ELISPOT responses', 'safety, tolerability, and immunogenicity', 'Env-specific CD4+ T-cell response rates']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0035978', 'cui_str': 'Rwanda'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0001483', 'cui_str': 'Adenoviridae'}, {'cui': 'C0439860', 'cui_str': 'Heterologous'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}]","[{'cui': 'C0017343', 'cui_str': 'ENV gene'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0920508', 'cui_str': 'Enzyme linked immunospot assay'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}]",,0.625106,"Solicited, self-limiting local, systemic reactogenicity and unsolicited adverse events were similar in vaccine groups and higher than in placebo groups.","[{'ForeName': 'Lindsey R', 'Initials': 'LR', 'LastName': 'Baden', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: lbaden@bwh.harvard.edu.""}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Stieh', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, Netherlands.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Sarnecki', 'Affiliation': 'Janssen Vaccines, Bern, Switzerland.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Walsh', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Georgia D', 'Initials': 'GD', 'LastName': 'Tomaras', 'Affiliation': 'Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Kublin', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'M Juliana', 'Initials': 'MJ', 'LastName': 'McElrath', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Galit', 'Initials': 'G', 'LastName': 'Alter', 'Affiliation': 'Ragon Institute of MGH, MIT, and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Ferrari', 'Affiliation': 'Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Montefiori', 'Affiliation': 'Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Mann', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Nijs', 'Affiliation': 'Janssen Infectious Diseases, Beerse, Belgium.'}, {'ForeName': 'Katleen', 'Initials': 'K', 'LastName': 'Callewaert', 'Affiliation': 'Ragon Institute of MGH, MIT, and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Goepfert', 'Affiliation': 'Division of Infectious Disease, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Srilatha', 'Initials': 'S', 'LastName': 'Edupuganti', 'Affiliation': 'Hope Clinic of the Emory Vaccine Center, Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Karita', 'Affiliation': 'Rwanda Zambia HIV Research Group, Kigali, Rwanda.'}, {'ForeName': 'Johannes P', 'Initials': 'JP', 'LastName': 'Langedijk', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Wegmann', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, Netherlands.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Corey', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Pau', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, Netherlands.'}, {'ForeName': 'Dan H', 'Initials': 'DH', 'LastName': 'Barouch', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA; Ragon Institute of MGH, MIT, and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Hanneke', 'Initials': 'H', 'LastName': 'Schuitemaker', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Tomaka', 'Affiliation': 'Janssen Research and Development, Titusville, NJ, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(20)30229-0'] 1507,33010323,"Tacrolimus 0.1% versus ciclopiroxolamine 1% for maintenance therapy in patients with severe facial seborrheic dermatitis: A multicenter, double-blind, randomized controlled study.","BACKGROUND No long-term maintenance therapy has been tested in patients with seborrheic dermatitis (SD). OBJECTIVE We sought to compare the efficacy and tolerance of tacrolimus 0.1% ointment versus ciclopiroxolamine 1% cream as maintenance therapy for severe SD. METHODS This double-blind randomized controlled study was conducted from 2014 to 2017 in 5 Dermatology Departments and 15 dermatology practices in France. Consecutive patients with severe and chronic facial SD were included. Patients were initially treated with desonide 0.05% cream twice daily for 7 days. Patients cleared after this open phase were randomized to receive tacrolimus 0.1% or ciclopiroxolamine 1% cream 2 times a week 24 weeks. The primary endpoint was disease-free-duration, defined as the time from randomization to first relapse. RESULTS One hundred fourteen patients were randomized (tacrolimus, n = 57; ciclopiroxolamine, n = 57). Twelve patients relapsed in the tacrolimus group after a median delay of 91.5 days (range 15-195 days) versus 23 patients in the ciclopiroxolamine group (median delay, 27 days [range 13-201 days]). Comparison of disease-free duration curves showed that patients in the tacrolimus group had a longer duration of complete remission than those in the ciclopiroxolamine group (P = .018), corresponding to a hazard ratio of relapse of 0.44 (95% confidence interval 0.22-0.89; P = .022). LIMITATIONS The theoretical sample size was not reached. CONCLUSION Tacrolimus 0.1% is more effective than ciclopiroxolamine 1% as maintenance therapy for patients with facial SD.",2021,Tacrolimus 0.1% ointment applied twice a week after 7 days of topical corticosteroids is more effective than ciclopiroxolamine 1% as maintenance therapy in patients with severe facial seborrheic dermatitis.,['patients with severe facial seborrheic dermatitis'],"['Tacrolimus', 'ciclopiroxolamine']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1275433', 'cui_str': 'Facial seborrheic dermatitis'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0126169', 'cui_str': 'Ciclopirox olamine'}]",[],,0.214147,Tacrolimus 0.1% ointment applied twice a week after 7 days of topical corticosteroids is more effective than ciclopiroxolamine 1% as maintenance therapy in patients with severe facial seborrheic dermatitis.,"[{'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Joly', 'Affiliation': 'Department of Dermatology, Rouen University Hospital and INSERM U1234, Centre de référence des maladies bulleuses autoimmunes, Normandie University, Rouen, France. Electronic address: Pascal.Joly@chu-rouen.fr.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Tejedor', 'Affiliation': 'Department of Dermatology, Rouen University Hospital and INSERM U1234, Centre de référence des maladies bulleuses autoimmunes, Normandie University, Rouen, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Tetart', 'Affiliation': 'Department of Allergology, Erik Satie Center, Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Hélène Collas', 'Initials': 'HC', 'LastName': 'Cailleux', 'Affiliation': 'private practice in Le Mesnil-Esnard, France.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Barrel', 'Affiliation': 'private practice in the St-Antoine Private Clinic, Rouen, France.'}, {'ForeName': 'Paul Arnaud', 'Initials': 'PA', 'LastName': 'De Preville', 'Affiliation': 'private practice in Rouen, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Mion-Mouton', 'Affiliation': 'private practice in Mont-Saint-Aignan, France.'}, {'ForeName': 'Germaine', 'Initials': 'G', 'LastName': 'Gabison', 'Affiliation': 'private practice in Saint-Maurice, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Baricault', 'Affiliation': 'private practice in the St-Antoine Private Clinic, Rouen, France.'}, {'ForeName': 'Catherine Girardin', 'Initials': 'CG', 'LastName': 'Tordeur', 'Affiliation': 'private practice in Bois-Guillaume, France.'}, {'ForeName': 'Martin Xavier', 'Initials': 'MX', 'LastName': 'Dore', 'Affiliation': 'private practice in Le Havre, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Rossi', 'Affiliation': 'private practice in Rouen, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Bourseau-Quetier', 'Affiliation': 'private practice in Blanquefort, France.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Chamaillard', 'Affiliation': 'private practice in Pessac, France.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Ly', 'Affiliation': 'private practice in Gradignan, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Chosidow', 'Affiliation': 'Department of Dermatology, Henri-Mondor University Hospital, Paris, France.'}, {'ForeName': 'Marie-Aleth', 'Initials': 'MA', 'LastName': 'Richard-Lallemand', 'Affiliation': 'CEReSS-EA 3279, Research Center in Health Services and Quality of Life Aix Marseille University, Dermatology Department, University Hospital Timone, Assistance Publique Hôpitaux de Marseille, Marseille, France.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Rzeznik', 'Affiliation': 'private practice in Fécamp, France.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Amici', 'Affiliation': 'private practice in Cenon, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Lair', 'Affiliation': 'private practice in Le Petit-Quevilly, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Bechu', 'Affiliation': 'private practice in the Mathilde Private Clinic, Rouen, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Benichou', 'Affiliation': 'Department of Biostatistics, Rouen University Hospital and INSERM U1219, Normandie University, Rouen, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Thill', 'Affiliation': 'Department of Biostatistics, Rouen University Hospital and INSERM U1219, Normandie University, Rouen, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Beylot-Barry', 'Affiliation': 'Department of Dermatology, INSERM U1053, Bordeaux University Hospital, Bordeaux, France.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.09.055'] 1508,33017065,Virtual Reality as Distraction Analgesia and Anxiolysis for Pediatric Otolaryngology Procedures.,"OBJECTIVES/HYPOTHESIS While virtual reality (VR) has been used as analgesia and anxiolysis for invasive procedures, no literature exists on the use of VR in the pediatric otolaryngology setting. The purpose of this study was to determine the efficacy of VR in reducing pain and anxiety for pediatric otolaryngology patients. STUDY DESIGN Randomized controlled trial. METHODS A total of 53 patients aged 7-17 undergoing in-office nasal endoscopies were included. Patients were randomized to receive VR or standard of care. Procedural pain, anxiety, and satisfaction scores were recorded from patients and caregivers. The physician filled out a childhood emotional manifestation scale (CEMS). RESULTS Patients in VR group reported a significant decrease in pain (0.80 ± 1.06 vs. 2.26 ± 2.38, P = .018) and anxiety (9.50 ± 12.48 vs. 38.48 ± 29.83, P = .0002) and increase in procedural satisfaction (6.40 ± 0.77 vs. 4.74 ± 1.74, P = .0002) compared to patients in control group. CEMS scores were significantly reduced in VR group (5.15 ± 0.46 vs. 9.64 ± 5.66, P = .0001) and caregiver anxiety levels were significantly reduced in VR group (11.50 ± 17.67 vs. 27.39 ± 30.48, P = .041) compared to control group. There were no reported side effects. Procedural time did not significantly differ between groups. CONCLUSIONS For pediatric otolaryngology patients undergoing in-office nasal endoscopies, VR is a safe and effective form of distraction analgesia and anxiolysis, significantly reducing pain and increasing procedural satisfaction for patients. In addition, VR significantly reduces anxiety for both patients and caregivers without disrupting procedural efficiency and workflow. LEVEL OF EVIDENCE 2. Laryngoscope, 131:E1714-E1721, 2021.",2021,"Procedural time did not significantly differ between groups. ","['pediatric otolaryngology patients', '53 patients aged 7-17 undergoing in-office nasal endoscopies were included']","['VR or standard of care', 'VR']","['pain and anxiety', 'procedural satisfaction', 'CEMS scores', 'side effects', 'Procedural time', 'childhood emotional manifestation scale (CEMS', 'Procedural pain, anxiety, and satisfaction scores', 'anxiety', 'caregiver anxiety levels', 'pain']","[{'cui': 'C1641593', 'cui_str': 'Pediatric otolaryngology'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0189024', 'cui_str': 'Endoscopy of nose'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1619712', 'cui_str': 'Procedural pain'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]",53.0,0.0523178,"Procedural time did not significantly differ between groups. ","[{'ForeName': 'Katherine Y', 'Initials': 'KY', 'LastName': 'Liu', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Icahn School of Medicine at Mount Sinai, New York, New York, U.S.A.'}, {'ForeName': 'Sen J', 'Initials': 'SJ', 'LastName': 'Ninan', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Icahn School of Medicine at Mount Sinai, New York, New York, U.S.A.'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Laitman', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Icahn School of Medicine at Mount Sinai, New York, New York, U.S.A.'}, {'ForeName': 'David Y', 'Initials': 'DY', 'LastName': 'Goldrich', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Icahn School of Medicine at Mount Sinai, New York, New York, U.S.A.'}, {'ForeName': 'Alfred M', 'Initials': 'AM', 'LastName': 'Iloreta', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Icahn School of Medicine at Mount Sinai, New York, New York, U.S.A.'}, {'ForeName': 'Aldo V', 'Initials': 'AV', 'LastName': 'Londino', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Icahn School of Medicine at Mount Sinai, New York, New York, U.S.A.'}]",The Laryngoscope,['10.1002/lary.29148'] 1509,33021443,Randomized Controlled Trial of Scrotal versus Inguinal Orchidopexy on Postoperative Pain.,"INTRODUCTION To compare the impact of orchidopexy approach (scrotal vs inguinal) on analgesic requirements, postoperative pain scores and complication rates. MATERIALS AND METHODS A superiority randomized controlled trial including boys 10 to 95 months of age at surgery, diagnosed with palpable undescended testis, was conducted. Patients with nonpalpable or bilateral undescended testis, previous inguinal surgery on the ipsilateral side and concurrent procedures were excluded. Block randomization with 1:1 allocation ratio and a standardized anesthesia protocol were employed. The primary outcome was postoperative pain and analgesic use in-hospital and at home using the validated pain scales FLACC (Face, Legs, Activity, Cry, and Consolability Behavioural Scale), CHEOPS (Children's Hospital of Eastern Ontario Pain Scale), PPPM (Parents Postoperative Pain Measure) and TPPPS (Toddler-Preschooler Postoperative Pain Scale). Secondary outcomes included operative time, conversion and success rates, and complications. An intention to treat protocol was followed. RESULTS We enrolled 173 patients, and 12 withdrew. Of the 161 patients who completed followup, 80 had scrotal orchidopexy and 81 inguinal orchidopexy. In-hospital use of ibuprofen (p=0.02) and acetaminophen (p <0.01), as well as FLACC (p <0.01) and CHEOPS (p=0.04) pain scores were slightly higher in patients who underwent orchidopexy. No difference in mean operative time and median at-home administration of analgesic was noted. The conversion rate was 24% (19/80). Of these, 13 (68%) were canalicular testes. The overall complication rate was 4% (6/161): 1 testicular atrophy, 3 re-ascents and 2 wound infections. Of these, 5 underwent scrotal orchidopexy and 1 had inguinal orchidopexy (wound infection). CONCLUSIONS Even though in-hospital mean postoperative pain scores and analgesic consumption were slightly lower for scrotal orchidopexy cases, the pain levels were mild across all scales. Median at-home analgesic use and pain scores were similar for both groups, as well as operative time and complication rates. Scrotal orchidopexy is an effective alternative to inguinal orchidopexy for low-lying undescended testis, as 68% of cases that needed conversion were canalicular testes.",2021,"In-hospital use of ibuprofen(p=0.02) and acetaminophen(p<0.01), as well as FLACC(p<0.01) and CHEOPS(p=0.04) pain scores were slightly higher in IO patients.","['Of the161 patients who completed follow-up, 80 had SO and 81 IO', 'Patients with non-palpable or bilateral UDT, previous inguinal surgery on the ipsilateral side and concurrent procedures were excluded', 'We enrolled 173 patients, 12 withdrew', 'boys 10-95 months of age at surgery, diagnosed with palpable undescended testis(UDT']","['acetaminophen(p<0.01', 'orchidopexy approach(scrotal[SO]vs.inguinal[IO', 'Scrotal Versus Inguinal Orchidopexy']","['Median at-home analgesic use and pain scores', 'analgesic requirements, postoperative pain scores and complication rates', 'operative time(OpT), conversion and success rates, and complications', 'pain levels', 'postoperative pain and analgesic use in hospital and at home using validated pain scales(FLACC,CHEOPS,PPPM,TPPPS', 'overall complication rate', 'Postoperative Pain', 'CHEOPS(p=0.04) pain scores', 'postoperative pain scores and analgesic consumption', 'mean OpT and median at-home administration of analgesic']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0522499', 'cui_str': 'Palpable'}, {'cui': 'C0431663', 'cui_str': 'Undescended testes - bilateral'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0018246', 'cui_str': 'Inguinal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0021358', 'cui_str': 'Structure of inferior colliculus of corpora quadrigemina'}]","[{'cui': 'C0194907', 'cui_str': 'Orchidopexy'}, {'cui': 'C0036471', 'cui_str': 'Scrotal'}, {'cui': 'C0018246', 'cui_str': 'Inguinal'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0262176', 'cui_str': 'Administration of analgesic'}]",173.0,0.371553,"In-hospital use of ibuprofen(p=0.02) and acetaminophen(p<0.01), as well as FLACC(p<0.01) and CHEOPS(p=0.04) pain scores were slightly higher in IO patients.","[{'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'McGrath', 'Affiliation': 'Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Forough', 'Initials': 'F', 'LastName': 'Farrokhyar', 'Affiliation': 'Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Luis H', 'Initials': 'LH', 'LastName': 'Braga', 'Affiliation': 'Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.'}]",The Journal of urology,['10.1097/JU.0000000000001379'] 1510,32307533,"Effect of artificial dawn light on cardiovascular function, alertness, and balance in middle-aged and older adults.","STUDY OBJECTIVES When arising in the morning, many older people experience dizziness and difficulty maintaining proper balance, as the cardiovascular system is not able to compensate to the postural shift (standing) and maintain sufficient blood flow to the brain. Such changes in cardiovascular function are observed in young individuals exposed to a dawn simulation light. In this study, we examined whether exposure to a dawn simulation light could impact cardiovascular function and consequent changes in balance in middle-aged and older adults. METHODS Twenty-three participants (67.3 ± 8.8 y), 12 of whom reported a history of dizziness in the morning, underwent two overnight stays in our laboratory. During both nights, they slept in complete darkness, except for the last 30 minutes of one of the nights during which a dawn simulation light was used. Continuous blood pressure (BP) and heart rate (HR) were monitored. Subjective and objective alertness, salivary cortisol, and mobile and standing balance were examined upon arising. RESULTS Dawn simulation light decreased (33%) the amount of sleep before morning awakening, lowered BP (6.24 mmHg), and increased HR (0.93 bpm). Despite these changes in physiology, there was no significant impact of dawn simulation on subjective or objective alertness, measures of standing or ambulatory balance, morning cortisol awakening response, or cardiovascular function after awakening. CONCLUSION While the dawn simulation did cause an increase in wake and a change in cardiovascular function prior to morning arousal in older adults, we could find no evidence of a functional change in either cardiovascular function or balance upon standing. CLINICAL TRIAL Registered on Clinicaltrials.gov, #NCT02632318, https://clinicaltrials.gov/ct2/show/NCT02632318.",2020,"Despite these changes in physiology, there was no significant impact of dawn simulation on subjective or objective alertness, measures of standing or ambulatory balance, morning cortisol awakening response, or cardiovascular function after awakening. ","['Twenty-three participants (67.3 ± 8.8 y), 12 of whom reported a history of dizziness in the morning, underwent two overnight stays in our laboratory', 'older adults', 'middle-aged and older adults', 'young individuals']",['artificial dawn light'],"['cardiovascular function', 'Subjective and objective alertness, salivary cortisol, and mobile and standing balance', 'amount of sleep before morning awakening, lowered BP', 'cardiovascular function, alertness, and balance', 'Continuous blood pressure (BP) and heart rate (HR', 'subjective or objective alertness, measures of standing or ambulatory balance, morning cortisol awakening response, or cardiovascular function']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C4517882', 'cui_str': '8.8'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0023693', 'cui_str': 'Light'}]","[{'cui': 'C0007227', 'cui_str': 'Cardiovascular function'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]",23.0,0.0366746,"Despite these changes in physiology, there was no significant impact of dawn simulation on subjective or objective alertness, measures of standing or ambulatory balance, morning cortisol awakening response, or cardiovascular function after awakening. ","[{'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Gabel', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Palo Alto, CA.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Miglis', 'Affiliation': 'Department of Neurology and Neurological Sciences, Stanford University, Palo Alto, CA.'}, {'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Zeitzer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Palo Alto, CA.'}]",Sleep,['10.1093/sleep/zsaa082'] 1511,33033863,Radiomics using CT images for preoperative prediction of futile resection in intrahepatic cholangiocarcinoma.,"OBJECTIVES To investigate and compare radiomics and clinical information for preoperative prediction of futile resection in intrahepatic cholangiocarcinoma (ICC). METHODS A total of 203 ICC patients from two centers were included and randomly allocated with a ratio of 7:3 into the training cohort and the validation cohort. Clinical characteristics and radiomics features were selected using random forest algorithm and logistic models to construct a clinical model and a radiomics model, respectively. A combined logistic model that incorporated the developed radiomics signature and clinical risk factors was then built. The performance of these models was evaluated and compared by plotting the receiver operating characteristic (ROC) curve and calculating the area under the curve (AUC). RESULTS The radiomics model showed a higher AUC than the clinical model in the validation cohort (AUC: 0.804 (95% CI: 0.697, 0.912) vs. 0.590 (95% CI: 0.415, 0.765), p = 0.043) for predicting futile resection in ICC. The radiomics model reached a sensitivity of 0.846 (95% CI: 0.546, 0.981) and a specificity of 0.771 (95% CI: 0.627, 0.880) in the validation cohort. Moreover, the radiomics model had comparable AUCs with the combined model in training and validation cohorts. CONCLUSIONS We presented an internally validated radiomics model for the prediction of futile resection in ICC patients. Compared with clinical information, radiomics using CT images had greater potential for predicting futile resection accurately before surgery. KEY POINTS • Radiomics model using CT images could predict futile resection in intrahepatic cholangiocarcinoma preoperatively. • Radiomics model using CT images was superior to clinical information for predicting futile resection accurately before surgery.",2021,"The radiomics model showed a higher AUC than the clinical model in the validation cohort (AUC: 0.804 (95% CI: 0.697, 0.912) vs. 0.590 (95% CI: 0.415, 0.765), p = 0.043) for predicting futile resection in ICC.","['203 ICC patients from two centers', 'ICC patients']",[],['receiver operating characteristic (ROC) curve and calculating the area under the curve (AUC'],"[{'cui': 'C0345905', 'cui_str': 'Intrahepatic bile duct carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}]",[],"[{'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",203.0,0.0356687,"The radiomics model showed a higher AUC than the clinical model in the validation cohort (AUC: 0.804 (95% CI: 0.697, 0.912) vs. 0.590 (95% CI: 0.415, 0.765), p = 0.043) for predicting futile resection in ICC.","[{'ForeName': 'Hongpeng', 'Initials': 'H', 'LastName': 'Chu', 'Affiliation': 'Department of Liver Surgery, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zelong', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Ultrasonics, Institute of Diagnostic and Interventional Ultrasound, The First Affiliated Hospital of Sun Yat-sen University, 58 Zhong Shan Road 2, Guangzhou, 510080, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Liang', 'Affiliation': 'Department of Radiology, The Zhu Jiang Hospital of Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Clinical Trial Unit, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Liver Surgery, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Lei', 'Affiliation': 'Department of Liver Surgery, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Mimi', 'Initials': 'M', 'LastName': 'Tang', 'Affiliation': 'Department of Radiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yiheng', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Clinical Trial Unit, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Shuling', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Ultrasonics, Institute of Diagnostic and Interventional Ultrasound, The First Affiliated Hospital of Sun Yat-sen University, 58 Zhong Shan Road 2, Guangzhou, 510080, China.'}, {'ForeName': 'Sui', 'Initials': 'S', 'LastName': 'Peng', 'Affiliation': 'Clinical Trial Unit, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China. pengsui@vip.163.com.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Kuang', 'Affiliation': 'Department of Liver Surgery, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China. kuangminda@hotmail.com.'}]",European radiology,['10.1007/s00330-020-07250-5'] 1512,33035075,Acceptability and Feasibility of an Isometric Resistance Exercise Program for Abdominal Cancer Surgery: An Embedded Qualitative Study.,"Although it is recognized in the early stages of cancer recovery that changes in lifestyle including increases in physical activity improves physical function, there are no clear findings whether low versus moderate intensity activity or home or gym exercise offer optimal benefit. Isometric-resistance exercises can be carried out with very little equipment and space and can be performed while patients are bed-bound in hospital or at home. This embedded qualitative study, based in an English hospital trust providing specialist cancer care, was undertaken as a component of a feasibility trial to evaluate the acceptability and feasibility of an isometric-resistance exercise program and explore the suitability of functional assessments by drawing from the experiences of abdominal cancer patients following surgery. Telephone interviews were undertaken with 7 participants in the intervention group, and 8 interviews with the usual care group (n = 15). The gender composition consisted of 11 females and 4 males. Participants' ages ranged from 27 to 84 (M = 60.07, SD = 15.40). Interviews were conducted between August 2017 and May 2018, with audio files digitally recorded and data coded using thematic framework analysis. Our results show that blinding to intervention or usual care was a challenge, participants felt the intervention was safe and suitable aided by the assistance of a research nurse, yet, found the self-completion questionnaire tools hard to complete. Our study provides an insight of trial processes, participants' adherence and completion of exercise interventions, and informs the design and conduct of larger RCTs based on the experiences of abdominal cancer surgery patients.",2020,"Our results show that blinding to intervention or usual care was a challenge, participants felt the intervention was safe and suitable aided by the assistance of a research nurse, yet, found the self-completion questionnaire tools hard to complete.","['11 females and 4 males', 'abdominal cancer surgery patients', 'Abdominal Cancer Surgery', 'abdominal cancer patients following surgery', ""Participants' ages ranged from 27 to 84 (M = 60.07, SD = 15.40""]","['isometric-resistance exercise program', 'Isometric Resistance Exercise Program', 'Isometric-resistance exercises']",['Acceptability and Feasibility'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0153662', 'cui_str': 'Malignant neoplasm of abdomen'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",11.0,0.034252,"Our results show that blinding to intervention or usual care was a challenge, participants felt the intervention was safe and suitable aided by the assistance of a research nurse, yet, found the self-completion questionnaire tools hard to complete.","[{'ForeName': 'Ferhana', 'Initials': 'F', 'LastName': 'Hashem', 'Affiliation': 'Centre for Health Service Studies, University of Kent, Canterbury, Kent, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Stephensen', 'Affiliation': 'Physiotherapy Department, East Kent Hospitals University Foundation NHS Trust, Kent and Canterbury Hospital, Canterbury, Kent, United Kingdom.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Bates', 'Affiliation': 'Centre for Health Service Studies, University of Kent, Canterbury, Kent, United Kingdom.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Pellatt-Higgins', 'Affiliation': 'Centre for Health Service Studies, University of Kent, Canterbury, Kent, United Kingdom.'}, {'ForeName': 'Ralph Nobby Peter', 'Initials': 'RNP', 'LastName': 'Hobbs', 'Affiliation': 'Maidstone and Tunbridge Wells NHS Trust, Maidstone, Maidstone Hospital, Hermitage Lane, Maidstone, Kent, United Kingdom.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Hopkins', 'Affiliation': 'Maidstone and Tunbridge Wells NHS Trust, Maidstone, Maidstone Hospital, Hermitage Lane, Maidstone, Kent, United Kingdom.'}, {'ForeName': 'Hazel', 'Initials': 'H', 'LastName': 'Woodward', 'Affiliation': 'Maidstone and Tunbridge Wells NHS Trust, Maidstone, Maidstone Hospital, Hermitage Lane, Maidstone, Kent, United Kingdom.'}, {'ForeName': 'Charitini', 'Initials': 'C', 'LastName': 'Stavropoulou', 'Affiliation': 'School of Health Sciences, City University, London, Northampton Square, United Kingdom.'}, {'ForeName': 'Ian L', 'Initials': 'IL', 'LastName': 'Swaine', 'Affiliation': 'Centre for Science and Medicine in Sport and Exercise, University of Greenwich, Gillingham, Chatham, United Kingdom.'}, {'ForeName': 'Haythem', 'Initials': 'H', 'LastName': 'Ali', 'Affiliation': 'Maidstone and Tunbridge Wells NHS Trust, Maidstone, Maidstone Hospital, Hermitage Lane, Maidstone, Kent, United Kingdom.'}]",Cancer control : journal of the Moffitt Cancer Center,['10.1177/1073274820950855'] 1513,33036201,A Partially Hydrolyzed Whey Infant Formula Supports Appropriate Growth: A Randomized Controlled Non-Inferiority Trial.,"The aim of the current study was to investigate the effects of a partially hydrolyzed whey infant formula (PHF) on growth in healthy term infants as compared to a standard infant formula with intact protein (IPF). In a double-blind, non-inferiority, randomized controlled trial, a total of 163 healthy formula-fed infants, 55-80 days old, were recruited and randomly allocated to either the PHF (test) or the IPF (control) group. They were followed up for three months during which they were evaluated monthly on growth and development. In total, 21 infants discontinued the study, while 142 infants completed the study (test n = 72, control n = 70). The primary outcome was daily weight gain during the three months. Secondary outcomes included additional anthropometric indices at every timepoint over the intervention period. Daily weight gain during the three-month intervention period was similar in both groups with the lower bound of 95% confidence interval (CI) above the non-inferiority margin of -3 g/day [mean difference (95% CI) test vs. control: -0.474 (-2.460, 1.512) g/day]. Regarding secondary outcomes, i.e., infants' weight, length, head circumference, body mass index (BMI), and their Z-scores, no differences were observed between the two groups at any time point. The PHF resulted in similar infant growth outcomes as the standard IPF. Based on these results, it can be concluded that the partially hydrolyzed whey infant formula supports adequate growth in healthy term infants.",2020,"Daily weight gain during the three-month intervention period was similar in both groups with the lower bound of 95% confidence interval (CI) above the non-inferiority margin of -3 g/day [mean difference (95% CI) test vs. control: -0.474 (-2.460, 1.512) g/day].","['163 healthy formula-fed infants, 55-80 days old', 'healthy term infants', '21 infants discontinued the study, while 142 infants completed the study (test n = 72, control n = 70']","['PHF (test) or the IPF (control) group', 'standard infant formula with intact protein (IPF', 'partially hydrolyzed whey infant formula (PHF']","['daily weight gain', ""infants' weight, length, head circumference, body mass index (BMI), and their Z-scores"", 'Daily weight gain', 'additional anthropometric indices at every timepoint']","[{'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0150589', 'cui_str': 'Infant formula'}, {'cui': 'C0034069', 'cui_str': 'Fibrosis of lung'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3853282', 'cui_str': 'Standard infant formula'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",163.0,0.293575,"Daily weight gain during the three-month intervention period was similar in both groups with the lower bound of 95% confidence interval (CI) above the non-inferiority margin of -3 g/day [mean difference (95% CI) test vs. control: -0.474 (-2.460, 1.512) g/day].","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Karaglani', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, 70 El. Venizelou Ave, 17671 Athens, Greece.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Thijs-Verhoeven', 'Affiliation': 'FrieslandCampina, Stationsplein 1, 3818 LE Amersfoort, The Netherlands.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Gros', 'Affiliation': 'FrieslandCampina, Stationsplein 1, 3818 LE Amersfoort, The Netherlands.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Chairistanidou', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, 70 El. Venizelou Ave, 17671 Athens, Greece.'}, {'ForeName': 'Giorgos', 'Initials': 'G', 'LastName': 'Zervas', 'Affiliation': 'Mitera hospital, 6 Erythrou Stavrou Str., 151 23 Athens, Greece.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Filoilia', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, 70 El. Venizelou Ave, 17671 Athens, Greece.'}, {'ForeName': 'Tarek-Michail', 'Initials': 'TM', 'LastName': 'Kampani', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, 70 El. Venizelou Ave, 17671 Athens, Greece.'}, {'ForeName': 'Vasileios', 'Initials': 'V', 'LastName': 'Miligkos', 'Affiliation': 'Mitera hospital, 6 Erythrou Stavrou Str., 151 23 Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Matiatou', 'Affiliation': 'Mitera hospital, 6 Erythrou Stavrou Str., 151 23 Athens, Greece.'}, {'ForeName': 'Stavroula', 'Initials': 'S', 'LastName': 'Valaveri', 'Affiliation': 'Mitera hospital, 6 Erythrou Stavrou Str., 151 23 Athens, Greece.'}, {'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Sakellariou', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, 70 El. Venizelou Ave, 17671 Athens, Greece.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Babilis', 'Affiliation': 'Mitera hospital, 6 Erythrou Stavrou Str., 151 23 Athens, Greece.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Bos', 'Affiliation': 'FrieslandCampina, Stationsplein 1, 3818 LE Amersfoort, The Netherlands.'}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Manios', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, 70 El. Venizelou Ave, 17671 Athens, Greece.'}]",Nutrients,['10.3390/nu12103056'] 1514,33038899,Blood Biomarkers and 6- to 7-Year Childhood Outcomes Following Neonatal Encephalopathy.,"OBJECTIVE This study aimed to profile the cytokine/chemokine response from day 0 to 7 in infants (≥36 weeks of gestational age) with neonatal encephalopathy (NE) and to explore the association with long-term outcomes. STUDY DESIGN This was a secondary study of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network randomized controlled trial of whole body hypothermia for NE. Eligible infants with moderate-severe NE were randomized to cooling or normothermia. Blood spots were collected on days 0 to 1, 2 to 4, and 6 to 7. Twenty-four cytokines/chemokines were measured using a multiplex platform. Surviving infants underwent neurodevelopmental assessment at 6 to 7 years. Primary outcome was death or moderate-severe impairment defined by any of the following: intelligence quotient <70, moderate-severe cerebral palsy (CP), blindness, hearing impairment, or epilepsy. RESULTS Cytokine blood spots were collected from 109 participants. In total 99 of 109 (91%) were assessed at 6 to 7 years; 54 of 99 (55%) developed death/impairment. Neonates who died or were impaired had lower early regulated upon activation normal T cell expressed and secreted (RANTES) and higher day 7 monocyte chemotactic protein (MCP)-1 levels than neonates who survived without impairment. Though TNF-α levels had no association with death/impairment, higher day 0 to 1 levels were observed among neonates who died/developed CP. On multiple regression analysis adjusted for center, treatment group, sex, race, and level of hypoxic ischemic encephalopathy, higher RANTES was inversely associated with death/impairment (odds ratio (OR): 0.31, 95% confidence interval [CI]: 0.13-0.74), while day seven MCP-1 level was directly associated with death/impairment (OR: 3.70, 95% CI: 1.42-9.61). Targeted cytokine/chemokine levels demonstrated little variation with hypothermia treatment. CONCLUSION RANTES and MCP-1 levels in the first week of life may provide potential targets for future therapies among neonates with encephalopathy. KEY POINTS · Elevation of specific cytokines and chemokines in neonates with encephalopathy has been noted along with increased risk of neurodevelopmental impairment in infancy.. · Cytokine/chemokines at <7 days were assessed among neonates in a trial of hypothermia for HIE.. · Neonates who died or were impaired at 6 to 7 years following hypoxic-ischemic encephalopathy had lower RANTES and higher MCP-1 levels than those who survived without impairment..",2020,Neonates who died or were impaired had lower early regulated upon activation normal T cell expressed and secreted (RANTES) and higher day 7 monocyte chemotactic protein (MCP)-1 levels than neonates who survived without impairment.,"['Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD', 'day 0 to 7 in infants (≥36 weeks of gestational age) with neonatal encephalopathy (NE', 'neonates with encephalopathy', 'Eligible infants with moderate-severe NE']",['cooling or normothermia'],"['monocyte chemotactic protein (MCP)-1 levels', 'death or moderate-severe impairment defined by any of the following: intelligence quotient <70, moderate-severe cerebral palsy (CP), blindness, hearing impairment, or epilepsy', 'MCP-1 levels', 'MCP-1 level', 'Blood spots', 'death/impairment']","[{'cui': 'C1513896', 'cui_str': 'National Institute of Child Health and Human Development'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0235820', 'cui_str': 'Neonatal encephalopathy'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0085584', 'cui_str': 'Encephalopathy'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0445103', 'cui_str': 'Normothermia'}]","[{'cui': 'C0282566', 'cui_str': 'Monocyte Chemotactic Proteins'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0456149', 'cui_str': 'Intelligence quotient'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}]",109.0,0.246804,Neonates who died or were impaired had lower early regulated upon activation normal T cell expressed and secreted (RANTES) and higher day 7 monocyte chemotactic protein (MCP)-1 levels than neonates who survived without impairment.,"[{'ForeName': 'Athina', 'Initials': 'A', 'LastName': 'Pappas', 'Affiliation': 'Department of Pediatrics, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Seetha', 'Initials': 'S', 'LastName': 'Shankaran', 'Affiliation': 'Department of Pediatrics, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'McDonald', 'Affiliation': 'Social, Statistical and Environmental Sciences Unit, RTI International, Research Triangle Park, North Carolina.'}, {'ForeName': 'Waldemar A', 'Initials': 'WA', 'LastName': 'Carlo', 'Affiliation': ""Department of Pediatrics, University of Alabama at Birmingham and Children's Hospital of Alabama, Birmingham, Alabama.""}, {'ForeName': 'Abbot R', 'Initials': 'AR', 'LastName': 'Laptook', 'Affiliation': ""Department of Pediatrics, Women & Infant's Hospital, Brown University, Providence, Rhode Island.""}, {'ForeName': 'Jon E', 'Initials': 'JE', 'LastName': 'Tyson', 'Affiliation': 'Department of Pediatrics, University of Texas Medical School at Houston, Houston, Texas.'}, {'ForeName': 'Abhik', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Social, Statistical and Environmental Sciences Unit, RTI International, Rockville, Maryland.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Skogstrand', 'Affiliation': 'Department for Congenital Disorders, Center for Neonatal Screening, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Hougaard', 'Affiliation': 'Department for Congenital Disorders, Center for Neonatal Screening, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Rosemary D', 'Initials': 'RD', 'LastName': 'Higgins', 'Affiliation': 'Department of Global and Community Health, George Mason University, Fairfax, Virginia.'}]",American journal of perinatology,['10.1055/s-0040-1717072'] 1515,33044111,Distal Radial Artery Access for Superficial Femoral Artery Interventions.,"PURPOSE To compare the acute success and complication rates of distal radial (DR) vs proximal radial (PR) artery access for superficial femoral artery (SFA) interventions. MATERIALS AND METHODS Between 2016 and 2019, 195 consecutive patients with symptomatic SFA stenosis were treated via DR (n=38) or PR (n=157) access using a sheathless guide. Secondary access was achieved through the pedal artery when necessary. The main outcomes were technical success, major adverse events (MAEs), and access site complications. Secondary outcomes were treatment success, fluoroscopy time, radiation dose, procedure time, and crossover rate to another puncture site. RESULTS Overall technical success was achieved in 188 patients (96.4%): 37 of 38 patients (97.3%) in the DR group and 151 of 157 patients (96.2%) in the PR group (p=0.9). Dual (transradial and transpedal) access was used in 14 patients (36.8%) in the DR group and 28 patients (18.9%) in the PR group (p<0.01). Chronic total occlusions were recanalized in 25 of 26 DR patients (96.1%) and in 79 of 81 PR patients (92.6%) (p=0.57). The crossover rate to femoral access was 0% in the DR group vs 3.2% in the PR group (p=0.59). Stents were implanted in the SFA in 15 DR patients (39.4%) and in 39 patients (24.8%) in the PR group (p=0.1). The contrast volume, fluoroscopy time, radiation dose, and procedure time were not statistically different between the DR and PR groups, nor were the rates of access site complications (2.6% and 7.0%, respectively). The cumulative incidences of MAE at 6 months in the DR and PR groups were 15.7% vs 14.6%, respectively (p=0.8). CONCLUSION SFA interventions can be safely and effectively performed using PR or DR access with acceptable morbidity and a high technical success rate. DR access is associated with few access site complications.",2021,"The contrast volume, fluoroscopy time, radiation dose, and procedure time were not statistically different between the DR and PR groups, nor were the rates of access site complications (2.6% and 7.0%, respectively).","['Between 2016 and 2019, 195 consecutive patients with symptomatic SFA stenosis were treated via DR (n=38) or PR (n=157) access using a sheathless guide']",['SFA interventions'],"['acute success and complication rates of distal radial (DR) vs proximal radial (PR) artery access', 'Chronic total occlusions', 'contrast volume, fluoroscopy time, radiation dose, and procedure time', 'treatment success, fluoroscopy time, radiation dose, procedure time, and crossover rate to another puncture site', 'rates of access site complications', 'technical success, major adverse events (MAEs), and access site complications', 'crossover rate to femoral access', 'Overall technical success', 'cumulative incidences of MAE']","[{'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0340574', 'cui_str': 'Superficial femoral artery stenosis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0447106', 'cui_str': 'Superficial femoral artery'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0589360', 'cui_str': 'Site of access'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0286540', 'cui_str': 'MAV protocol'}]",195.0,0.0501676,"The contrast volume, fluoroscopy time, radiation dose, and procedure time were not statistically different between the DR and PR groups, nor were the rates of access site complications (2.6% and 7.0%, respectively).","[{'ForeName': 'Zoltán', 'Initials': 'Z', 'LastName': 'Ruzsa', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Ádám', 'Initials': 'Á', 'LastName': 'Csavajda', 'Affiliation': 'Cardiology Division, Invasive Cardiology, Bács-Kiskun County Hospital, Kecskemét, Hungary.'}, {'ForeName': 'Balázs', 'Initials': 'B', 'LastName': 'Nemes', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Mónika', 'Initials': 'M', 'LastName': 'Deák', 'Affiliation': 'Cardiology Division, Invasive Cardiology, Bács-Kiskun County Hospital, Kecskemét, Hungary.'}, {'ForeName': 'Péter', 'Initials': 'P', 'LastName': 'Sótonyi', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Olivier F', 'Initials': 'OF', 'LastName': 'Bertrand', 'Affiliation': 'Quebec Heart-Lung Institute, University Laval, Quebec, QC, Canada.'}, {'ForeName': 'Béla', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary.'}]",Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists,['10.1177/1526602820963022'] 1516,33044119,Heparin-Bonded Stent-Graft for the Treatment of TASC II C and D Femoropopliteal Lesions: 36-Month Results of the Viabahn 25 cm Trial.,"PURPOSE To evaluate the 36-month technical and clinical outcome after implantation of the 25-cm Viabahn endoprosthesis with Propaten bioactive surface in TransAtlantic Inter-Society Consensus II C and D lesions of the superficial femoral and proximal popliteal arteries. MATERIALS AND METHODS This prospective, multicenter, single-arm trial ( ClinicalTrials.gov ; identifier NCT01263665) enrolled 71 patients (mean age 66.7±8.3 years; 50 men) with lifestyle-limiting claudication or rest pain (Rutherford category 2-4) and long (>20-cm) lesions of the superficial femoral and proximal popliteal arteries. Primary endpoint was primary patency at 36 months. Secondary endpoints included primary assisted patency; secondary patency; freedom from target lesion revascularization (TLR); freedom from a composite of death, target vessel revascularization (TVR), and amputation; clinical success; and freedom from device fracture. RESULTS Primary patency estimated by Kaplan-Meier analysis was 40.6% at 36 months. Primary assisted patency and secondary patency estimates were 53.0% and 96.9%, respectively. Within 36 months, 27 patients had to undergo a TLR. Twenty-five patients (35.2%) had a TVR. Freedom from the composite of death, TVR, and amputation endpoint was 44.5%. The estimate of the sustained clinical success with stable or improved Rutherford category was 58.5%. No stent fracture was detected during follow-up. CONCLUSION The primary patency rate without reintervention after treatment of long femoropopliteal lesions is low. However, secondary patency after implantation of a Viabahn endoprosthesis is high and seems to be superior to the use of other revascularization techniques, resulting in persistent clinical improvement.",2021,"No stent fracture was detected during follow-up. ","['TASC II C and D Femoropopliteal Lesions', '71 patients (mean age 66.7±8.3 years; 50 men) with lifestyle-limiting claudication or rest pain (Rutherford category 2-4) and long (>20-cm) lesions of the superficial femoral and proximal popliteal arteries', '27 patients had to undergo a TLR']","['Heparin-Bonded Stent-Graft', '25-cm Viabahn endoprosthesis with Propaten bioactive surface', 'Viabahn endoprosthesis']","['TVR', 'death, TVR, and amputation endpoint', 'stent fracture', 'primary assisted patency; secondary patency; freedom from target lesion revascularization (TLR); freedom from a composite of death, target vessel revascularization (TVR), and amputation; clinical success; and freedom from device fracture', 'patency and secondary patency estimates', 'patency rate without reintervention']","[{'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0021775', 'cui_str': 'Intermittent claudication'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0032649', 'cui_str': 'Structure of popliteal artery'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]","[{'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C4704931', 'cui_str': 'Endoprostheses'}, {'cui': 'C0205148', 'cui_str': 'Surface'}]","[{'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3160928', 'cui_str': 'Device fracture'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",71.0,0.133844,"No stent fracture was detected during follow-up. ","[{'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Böhme', 'Affiliation': 'Department Angiology, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Noory', 'Affiliation': 'Department Angiology, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Brechtel', 'Affiliation': 'Department Radiology, MVZ GmbH Berlin-Tiergarten, Berlin, Germany.'}, {'ForeName': 'Dierk', 'Initials': 'D', 'LastName': 'Scheinert', 'Affiliation': 'University Hospital Leipzig, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Bosiers', 'Affiliation': 'Department Vascular Surgery, A.Z. Sint-Blasius, Dendermonde, Belgium.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Beschorner', 'Affiliation': 'CoreLab Black Forest Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Zeller', 'Affiliation': 'Department Angiology, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.'}]",Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists,['10.1177/1526602820965965'] 1517,33039382,Early changes in appetite and energy expenditure are not associated to body weight and fat losses in pre-menopausal women living with overweight/obesity.,"BACKGROUND The aim of the study was to investigate whether early changes (1-week) in energy balance-related measures would predict changes in body weight (BW) and fat losses in women living with overweight/obesity. METHODS BW, body composition (DXA), resting energy expenditure (REE)(indirect calorimetry), olfactory performance (Sniffin' Sticks), appetite and palatability (visual analogue scale) were measured at baseline, after a 1-week of caloric restriction as well as post-intervention (at 10 and 20 weeks) in a group of 30 women living with overweight/obesity. RESULTS A significant decrease in REE (p = 0.033) was noted after 1 week. Fasting desire to eat (p = 0.004), hunger (p = 0.001) and prospective food consumption (p = 0.001) all increased after 1 week. Similarly, significant increases in AUC SQ for desire to eat (p = 0.01), hunger (p = 0.005) and prospective food consumption (p = 0.001) were noted after 1 week. However, these early changes were not associated to final BW or FM losses at the end of the weight loss intervention. CONCLUSION Despite significant changes in REE and appetite soon after the onset of a BW loss intervention, these early changes do not seem to predict final BW or FM losses at the end of the program in women living with overweight/obesity.",2021,"Similarly, significant increases in AUC SQ for desire to eat (p = 0.01), hunger (p = 0.005) and prospective food consumption (p = 0.001) were noted after 1 week.","['pre-menopausal women living with overweight/obesity', '30 women living with overweight/obesity', 'women living with overweight/obesity']",[],"['appetite and energy expenditure', 'Fasting desire to eat', 'body weight (BW) and fat losses', 'prospective food consumption', 'final BW or FM losses', 'REE and appetite', 'hunger', ""body composition (DXA), resting energy expenditure (REE)(indirect calorimetry), olfactory performance (Sniffin' Sticks), appetite and palatability (visual analogue scale"", 'body weight and fat losses', 'REE', 'AUC SQ for desire to eat']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",[],"[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0006779', 'cui_str': 'Calorimetry'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C1706582', 'cui_str': 'Stick'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",30.0,0.0260886,"Similarly, significant increases in AUC SQ for desire to eat (p = 0.01), hunger (p = 0.005) and prospective food consumption (p = 0.001) were noted after 1 week.","[{'ForeName': 'Luzia Jaeger', 'Initials': 'LJ', 'LastName': 'Hintze', 'Affiliation': 'Behavioural Metabolic Research Unit, School of Human Kinetics, University of Ottawa, Ottawa, K1N 6N5, Canada.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Goldfield', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, Ottawa, K1H 8L1, Canada.""}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Séguin', 'Affiliation': 'Behavioural Metabolic Research Unit, School of Human Kinetics, University of Ottawa, Ottawa, K1N 6N5, Canada; Ryan Séguin is deceased.'}, {'ForeName': 'Aleck', 'Initials': 'A', 'LastName': 'Damphousse', 'Affiliation': 'Behavioural Metabolic Research Unit, School of Human Kinetics, University of Ottawa, Ottawa, K1N 6N5, Canada.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Riopel', 'Affiliation': 'Behavioural Metabolic Research Unit, School of Human Kinetics, University of Ottawa, Ottawa, K1N 6N5, Canada.'}, {'ForeName': 'Éric', 'Initials': 'É', 'LastName': 'Doucet', 'Affiliation': 'Behavioural Metabolic Research Unit, School of Human Kinetics, University of Ottawa, Ottawa, K1N 6N5, Canada. Electronic address: edoucet@uottawa.ca.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113201'] 1518,33040600,Does Miniaturization Actually Decrease Bleeding After Percutaneous Nephrolithotomy? A Single-Center Randomized Trial.,"Introduction: Miniaturization of percutaneous nephrolithotomy (mPCNL) was proposed to decrease postoperative bleeding, as there is decreased parenchymal injury compared with standard percutaneous nephrolithotomy (SPCNL). Published randomized controlled trials (RCTs) evaluating bleeding after mPCNL have shown conflicting results. Hence, the evidence to say that mPCNL offers less postoperative bleeding is not robust. Materials and Methods: Prospective RCT was done by comparing mPCNL and SPCNL for treatment of renal stones of size 1 to 3 cm. Patients with active urinary tract infection, renal malformation, uncorrected coagulopathy, and raised serum creatinine (>1.5 mg/dL) were excluded. Blood loss was evaluated by measuring fall in hemoglobin and hematocrit on postoperative day 1. Postoperative pain was evaluated by visual analogue scale (VAS) score at 6, 24, and 48 hours. Results: A total of 60 patients (30 in each arm) were enrolled during the study period. All the baseline preoperative variables were comparable in both the groups. The SPCNL group had a significantly higher drop in hematocrit level as compared with mPCNL (4.6 ± 3.1% vs 3.1 ± 2.1%, p  = 0.02). The mean fall in hemoglobin was higher in SPCNL as compared with mPCNL (1.61 ± 0.9 gm% vs 1.21 ± 0.7 gm%, p  = 0.07), but it was not significant. Blood transfusion (BT) rate was comparable in both the groups (one patient in each group). The mPCNL group had significantly less VAS scores at 6 hours (3.27 ± 1.20 vs 4.40 ± 1.52, p  = 0.002) and 24 hours (2.10 ± 0.54 vs 2.83 ± 1.05, p  = 0.001) after surgery. Postoperative complications and hospital stay were comparable in both the arms. Conclusion: mPCNL is associated with less postoperative bleeding and pain than SPCNL. However, the small tract size does not prevent against the clinically significant bleeding requiring BT.",2021,"Mean fall in haemoglobin was higher in SPCNL as compared to mPCNL (1.61±0.9 gm% vs. 1.21±0.7 gm%, p value=0.07) but was not significant.","['Patients with active urinary tract infection, renal malformation, uncorrected coagulopathy and raised serum creatinine(>1.5mg/dl) were excluded', 'renal stones of size 1-3cm', '60 patients (30 in each arm) were enrolled during the study period']","['mPCNL and SPCNL', 'percutaneous nephrolithotomy (mPCNL', 'mPCNL', 'standard percutaneous nephrolithotomy (SPCNL']","['postoperative bleeding', 'Postoperative complications and hospital stay', 'VAS scores', 'visual analogue scale (VAS) score', 'haematocrit level', 'Mean fall in haemoglobin', 'Blood loss', 'Blood transfusion rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C4551596', 'cui_str': 'Kidney malformation'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0026164', 'cui_str': 'Miniaturisation'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]",60.0,0.0777288,"Mean fall in haemoglobin was higher in SPCNL as compared to mPCNL (1.61±0.9 gm% vs. 1.21±0.7 gm%, p value=0.07) but was not significant.","[{'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Thakur', 'Affiliation': 'Department of Urology, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Aditya Prakash', 'Initials': 'AP', 'LastName': 'Sharma', 'Affiliation': 'Department of Urology, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Sudheer Kumar', 'Initials': 'SK', 'LastName': 'Devana', 'Affiliation': 'Department of Urology, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Kalpesh Mahesh', 'Initials': 'KM', 'LastName': 'Parmar', 'Affiliation': 'Department of Urology, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Ravimohan S', 'Initials': 'RS', 'LastName': 'Mavuduru', 'Affiliation': 'Department of Urology, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Girdhar S', 'Initials': 'GS', 'LastName': 'Bora', 'Affiliation': 'Department of Urology, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Arup Kumar', 'Initials': 'AK', 'LastName': 'Mandal', 'Affiliation': 'Department of Urology, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}]",Journal of endourology,['10.1089/end.2020.0533'] 1519,33045085,The Cigarette Smoking Initiation and Continuation in Adolescents Undergoing a Long-Term Behavioral Intervention.,"INTRODUCTION Targeting adolescents' smoking reduces its burden on health systems. We investigated the effects of the first multidisciplinary community-based lifestyle intervention in the Eastern Mediterranean region, on smoking initiation, continuation, and risk of current smoking in Iranian adolescents. METHODS The current analyses were conducted on 945 nonsmoker adolescents (12-18 years) who participated in Phase II of Tehran Lipid and Glucose Study (TLGS) and were examined four times in 12 years. The lifestyle intervention including school-based and public programs was implemented, focusing on all components of healthy lifestyle. Using a two-step cluster analysis, families were classified as high and low risk, based on parental risk factors of adolescents' smoking. Participants who failed to complete all the follow-ups (n = 99) and those with missing smoking data were excluded. Subsequently, 872 adolescents (538 control, 334 intervention) were included in the Cox model on smoking initiation, and 674 adolescents (414 control, 260 intervention) were included in the logistic regression on smoking status. RESULTS Mean age of adolescents was 15.08 ± 1.94 years at baseline. The hazard of the smoking initiation was significantly lower in the intervention (hazard ratio = 0.71, 95% confidence interval: 0.51-0.99; p = .044) compared with control group. At the end of the fourth follow-up, intervention reduced the odds of current cigarette smoking by 29%. Within the intervention group, the high-risk cluster was at a 35% lower risk of initiating smoking and had 37% lower odds of becoming a current smoker. However, the intervention could not make a difference in preventing those who initiated smoking from maintaining it during the follow-ups. CONCLUSIONS Our results demonstrate that lifestyle modification programs targeting at-risk populations could reduce risk of smoking initiation and current smoking in adolescents in long term. IMPLICATIONS Experiencing cigarette smoking at the critical period of adolescence could result in adulthood habitual smoking. Therefore, identifying adolescents who are more at risk of smoking initiation and implementing targeted interventions are of great importance in public health. Our findings highlight the long-term effectiveness of a multidisciplinary community-based behavioral intervention on forming smoking behaviors in adolescents. The current intervention was successful in reducing smoking uptake in adolescents living in high-risk families.",2021,"The hazard of the smoking initiation was significantly lower in the intervention (HR=0.71, 95% CI: 0.51-0.99; P=0.044) compared to control group.","['Iranian adolescents', 'Participants who failed to complete all the follow-ups (n=99) and those with missing smoking data were excluded', 'adolescents undergoing a long-term behavioral intervention', '945 non-smoker adolescents (12-18 years) who participated in Phase II of Tehran Lipid and Glucose Study (TLGS) and were examined four times in 12 years', '872 adolescents (538 control, 334 intervention) were included in the Cox model on smoking initiation and 674 adolescents (414 control, 260 intervention', 'adolescents', 'adolescents living in high-risk families']","['multidisciplinary community-based lifestyle intervention', 'multidisciplinary community-based behavioral intervention']","['odds of current cigarette smoking', 'smoking uptake', 'hazard of the smoking initiation', 'risk of smoking initiation and current smoking']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517729', 'cui_str': '334'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0010234', 'cui_str': 'Cox Models'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C4517771', 'cui_str': '414'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",945.0,0.0157767,"The hazard of the smoking initiation was significantly lower in the intervention (HR=0.71, 95% CI: 0.51-0.99; P=0.044) compared to control group.","[{'ForeName': 'Hasti', 'Initials': 'H', 'LastName': 'Masihay-Akbar', 'Affiliation': 'Research Center for Social Determinants of Health, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Amiri', 'Affiliation': 'Research Center for Social Determinants of Health, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Cheraghi', 'Affiliation': 'Department of Biostatistics and Epidemiology, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir Abbas', 'Initials': 'AA', 'LastName': 'Momenan', 'Affiliation': 'Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fereidoun', 'Initials': 'F', 'LastName': 'Azizi', 'Affiliation': 'Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa208'] 1520,33047127,"Harsh and Sweet Sensations Predict Acute Liking of Electronic Cigarettes, but Flavor Does Not Affect Acute Nicotine Intake: A Pilot Laboratory Study in Men.","INTRODUCTION Electronic cigarette use is increasing in popularity, and thousands of flavors are available. Adolescent vaping rates in the United States have nearly doubled in the past year. Unlike combustible tobacco, added flavors are not currently regulated for some types of electronic cigarette products. Here, we investigated the role of flavor in electronic cigarette liking and acute intake. METHODS Men (n = 39) aged 18-45 vaped in a controlled laboratory setting after being randomized to one of four e-liquids: 6 mg nicotine/mL cherry, 18 mg/mL cherry, 6 mg/mL chocolate, or 18 mg/mL chocolate. They completed several questionnaires, and vaped ad libitum for 10 minutes. After the first puff, participants rated sensations (sweetness, bitterness, coolness, harshness/irritation) on general labeled magnitude scales (gLMS) and rated overall liking on a generalized hedonic scale. Once the 10-minute session ended, participants made another set of ratings. RESULTS Liking was generally stable across the vaping session and liking varied substantially across the four conditions. Across all conditions, sensory ratings predicted liking: harshness/irritation was negatively associated with first puff liking, whereas perceived sweetness was positively associated with first puff liking. First puff liking associated with increased amount of e-liquid vaped, but not total nicotine intake. Participants appeared to titrate their nicotine intake regardless of assigned condition. CONCLUSION Flavored e-liquids affect acute liking ratings, but not acute nicotine intake. IMPLICATIONS These data suggest individuals who regularly vape may titrate their nicotine intake, regardless of flavor, and contrary to expectations, acute liking did not predict total nicotine intake. However, more-liked flavors may potentially make higher nicotine levels more tolerable by adding pleasant sensations directly, rather than by perceptual masking that reduces aversive sensations.",2021,"Across all conditions, sensory ratings predicted liking: harshness/irritation was negatively associated with first puff liking while perceived sweetness was positively associated with first puff liking.","['men', 'Men (n=39) aged 18-45 vaped in a controlled laboratory setting after being randomized to one of four e-liquids: 6mg']","['nicotine/ml Cherry, 18mg', 'ml Chocolate']","['Adolescent vaping rates', 'acute nicotine intake', 'aversive sensations', 'rated sensations (sweetness, bitterness, coolness, harshness/irritation) on general labeled magnitude scales (gLMS) and rated overall liking on a generalized hedonic scale']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C4543628', 'cui_str': 'Electronic cigarette liquid'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0330657', 'cui_str': 'Prunus cerasus'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0052148', 'cui_str': 'APEL protocol'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0235290', 'cui_str': 'Taste bitter'}, {'cui': 'C0234804', 'cui_str': 'Harsh voice quality'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0726671,"Across all conditions, sensory ratings predicted liking: harshness/irritation was negatively associated with first puff liking while perceived sweetness was positively associated with first puff liking.","[{'ForeName': 'Allison N', 'Initials': 'AN', 'LastName': 'Baker', 'Affiliation': 'Graduate Program in Neuroscience, The Pennsylvania State University, University Park, PA.'}, {'ForeName': 'Alyssa J', 'Initials': 'AJ', 'LastName': 'Bakke', 'Affiliation': 'Sensory Evaluation Center, The Pennsylvania State University, University Park, PA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Branstetter', 'Affiliation': 'Department of Biobehavioral Health, The Pennsylvania State University, University Park, PA.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Hayes', 'Affiliation': 'Graduate Program in Neuroscience, The Pennsylvania State University, University Park, PA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa209'] 1521,33047625,"Exercise and Cognitive Training Intervention Improves Self-Care, Quality of Life and Functional Capacity in Persons With Heart Failure.","This study evaluated a 12-week, home-based combined aerobic exercise (walking) and computerized cognitive training (EX/CCT) program on heart failure (HF) self-care behaviors (Self-care of HF Index [SCHFI]), disease specific quality of life (Kansas City Cardiomyopathy Questionnaire [KCCQ]), and functional capacity (6-minute walk distance) compared to exercise only (EX) or a usual care attention control (AC) stretching and flexibility program. Participants ( N = 69) were older, predominately female (54%) and African American (55%). There was significant improvement in self-care management, F (2, 13) = 5.7, p < .016; KCCQ physical limitation subscale, F (2, 52) = 3.4, p < .039; and functional capacity (336 ± 18 vs 388 ± 20 m, p < .05) among the EX/CCT participants. The underlying mechanisms that EX and CCT targets and the optimal dose that leads to improved outcomes are needed to design effective interventions for this rapidly growing population.",2020,"There was significant improvement in self-care management, F (2, 13) = 5.7, ","['Participants ( N = 69) were older, predominately female (54%) and African American (55', 'Persons With Heart Failure']","['exercise only (EX) or a usual care attention control (AC) stretching and flexibility program', 'Exercise and Cognitive Training Intervention', 'home-based combined aerobic exercise (walking) and computerized cognitive training (EX/CCT) program']","['Self-Care, Quality of Life and Functional Capacity', 'self-care management, F', 'heart failure (HF) self-care behaviors (Self-care of HF Index [SCHFI]), disease specific quality of life (Kansas City Cardiomyopathy Questionnaire [KCCQ]), and functional capacity (6-minute walk distance', 'functional capacity']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332251', 'cui_str': 'Predominate'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}]",69.0,0.0130434,"There was significant improvement in self-care management, F (2, 13) = 5.7, ","[{'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Gary', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Sudeshna', 'Initials': 'S', 'LastName': 'Paul', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Corwin', 'Affiliation': 'Columbia University, New York City, USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Butts', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Miller', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Hepburn', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Drenna', 'Initials': 'D', 'LastName': 'Waldrop', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}]",Journal of applied gerontology : the official journal of the Southern Gerontological Society,['10.1177/0733464820964338'] 1522,33047687,Enhanced recovery after surgery in laparoscopic distal gastrectomy: Protocol for a prospective single-arm clinical trial.,"Background The enhanced recovery after surgery (ERAS) programme is feasible and effective in reducing the length of hospital stay, overall complication rates and medical costs when applied to cases involving colonic and rectal resections. However, a recent prospective, randomised, open, parallel-controlled trial (Chinese Laparoscopic Gastrointestinal Surgery Study-01 trial), initiated by our team, indicated that under conventional peri-operative management, the reduction of the post-operative hospital stay of laparoscopic distal gastrectomy (LDG) is quite limited compared with open gastrectomy. Thus, if we could provide valuable clinical evidence for demonstrating the efficacy of the ERAS programme for gastric cancer patients undergoing LDG, it would significantly enhance the peri-operative management of gastrectomy and benefit the patients. Methods In this prospective single-arm trial, patients who are 18-75 years of age with gastric adenocarcinoma diagnosed with cT1-4aN0-3M0 and expected to undergo curative resection through LDG, are considered eligible for this study. All participants underwent LDG with peri-operative management under the ERAS programme. The primary outcome measures included the post-operative hospital stays and rehabilitative rate of the post-operative day 4. The secondary outcome measures are morbidity and mortality (time frame: 30 days), post-operative recovery index (time frame: 30 days), post-operative pain intensity (time frame: 3 days) and the medical costs from surgery to discharge. Conclusion With reasonable and scientific designing, the trial may be a great help to further discuss the benefit of ERAS programme and thus improving the peri-operative management of patients with gastrectomy.",2020,"The enhanced recovery after surgery (ERAS) programme is feasible and effective in reducing the length of hospital stay, overall complication rates and medical costs when applied to cases involving colonic and rectal resections.","['All participants underwent LDG with peri-operative management under the ERAS programme', 'gastric cancer patients undergoing LDG', 'patients with gastrectomy', 'patients who are 18-75 years of age with gastric adenocarcinoma diagnosed with cT1-4aN0-3M0 and expected to undergo curative resection through LDG, are considered eligible for this study']","['laparoscopic distal gastrectomy (LDG', 'ERAS programme', 'laparoscopic distal gastrectomy', 'surgery (ERAS) programme']","['morbidity and mortality (time frame: 30 days), post-operative recovery index (time frame: 30 days), post-operative pain intensity (time frame: 3 days) and the medical costs from surgery to discharge', 'post-operative hospital stays and rehabilitative rate of the post-operative day 4', 'length of hospital stay, overall complication rates and medical costs']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0192440', 'cui_str': 'Distal subtotal gastrectomy'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0278701', 'cui_str': 'Adenocarcinoma of stomach'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1438035', 'cui_str': 'SLC6A8 protein, human'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0192440', 'cui_str': 'Distal subtotal gastrectomy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332168', 'cui_str': 'Time frame'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0800456,"The enhanced recovery after surgery (ERAS) programme is feasible and effective in reducing the length of hospital stay, overall complication rates and medical costs when applied to cases involving colonic and rectal resections.","[{'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Mingli', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yanfeng', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yuehong', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Guoxin', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}]",Journal of minimal access surgery,['10.4103/jmas.JMAS_35_19'] 1523,33048635,Feasibility and Acceptability of an Interactive Cancer-Communication Video Program Using African American Breast Cancer Survivor Stories.,"To examine the feasibility and acceptability of an interactive video program of African American breast cancer survivor stories, we explored story reactions among African American women with newly diagnosed breast cancer and associations between patient factors and intervention use. During a randomized controlled trial, patients in the intervention arm completed a baseline/pre-intervention interview, received the video intervention, and completed a post-intervention 1-month follow-up interview. Additional video exposures and post-exposure interviews occurred at 6- and 12-month follow-ups. Multivariable linear mixed-effects models examined interview and clinical data in association with changes in minutes and actions using the program. After Exposure1, 104 of 108 patients allocated to the intervention reported moderate-to-high levels of positive emotional reactions to stories and identification with storytellers. Exposure1 mean usage was high (139 minutes) but declined over time ( p <.0001). Patients receiving surgery plus radiation logged about 50 more minutes and actions over 12-month follow-up than patients receiving surgery only ( p <.05); patients reporting greater trust in storytellers logged 18.6 fewer actions over time ( p =.04). Patients' topical interests evolved, with patients watching more follow-up care and survivorship videos at Exposure3. The intervention was feasible and evaluated favorably. New videos might satisfy patients' changing interests.",2020,"After Exposure1, 104 of 108 patients allocated to the intervention reported moderate-to-high levels of positive emotional reactions to stories and identification with storytellers.","['African American women with newly diagnosed breast cancer and associations between patient factors and intervention use', 'African American breast cancer survivor stories']","['Interactive Cancer-Communication Video Program', 'baseline/pre-intervention interview, received the video intervention, and completed a post-intervention 1-month follow-up interview', 'interactive video program']","['Feasibility and Acceptability', 'moderate-to-high levels of positive emotional reactions to stories and identification with storytellers', 'feasibility and acceptability']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0221736', 'cui_str': 'Reaction emotional'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}]",,0.0261986,"After Exposure1, 104 of 108 patients allocated to the intervention reported moderate-to-high levels of positive emotional reactions to stories and identification with storytellers.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pérez', 'Affiliation': 'School of Medicine, Department of Medicine, Washington University in St. Louis , Saint Louis, Missouri, USA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Kreuter', 'Affiliation': 'The Brown School, Washington University in St. Louis , Saint Louis, Missouri, USA.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine , Saint Louis, Missouri, USA.'}, {'ForeName': 'Tess', 'Initials': 'T', 'LastName': 'Thompson', 'Affiliation': 'The Brown School, Washington University in St. Louis , Saint Louis, Missouri, USA.'}, {'ForeName': 'Julianne', 'Initials': 'J', 'LastName': 'Sefko', 'Affiliation': 'School of Medicine, Department of Surgery, Washington University in St. Louis , St. Louis, Missouri, USA.'}, {'ForeName': 'Balaji', 'Initials': 'B', 'LastName': 'Golla', 'Affiliation': 'The Brown School, Washington University in St. Louis , Saint Louis, Missouri, USA.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Margenthaler', 'Affiliation': 'Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine , Saint Louis, Missouri, USA.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Colditz', 'Affiliation': 'Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine , Saint Louis, Missouri, USA.'}, {'ForeName': 'Donna B', 'Initials': 'DB', 'LastName': 'Jeffe', 'Affiliation': 'School of Medicine, Department of Medicine, Washington University in St. Louis , Saint Louis, Missouri, USA.'}]",Journal of health communication,['10.1080/10810730.2020.1821132'] 1524,33022957,Short-Term Effects of Salt Restriction via Home Dishes Do Not Persist in the Long Term: A Randomized Control Study.,"Salt intake reduction is crucial to prevent non-communicable diseases (NCDs) globally. This study aimed to investigate the short- and long-term effects of monitoring salt concentration in homemade dishes on reducing salt intake in a Japanese population. A double-blind randomized controlled trial using a 2 × 2 factorial design with two interventions was conducted in 195 participants; they were assigned to both interventions for a group monitoring salt concentration in soups (control: no monitoring) and a group using low-sodium seasoning (control: regular seasoning). We evaluated 24-hour urinary sodium excretions at baseline and after a three-month intervention for the changes as major outcomes, at six- and twelve-months after baseline as long-term follow-up surveys. Urinary sodium excretion decreased in both intervention and control groups after the intervention. However, differences in the change for both monitoring and low-sodium seasoning interventions were statistically non-significant ( p = 0.29 and 0.52, respectively). Urinary sodium excretion returned to the baseline level after twelve-months for all groups. Monitoring of salt concentration is ineffective in reducing salt intake for short- and long-term among the people studied in this cohort.",2020,Urinary sodium excretion decreased in both intervention and control groups after the intervention.,"['195 participants', 'a Japanese population']","['group monitoring salt concentration in soups (control: no monitoring) and a group using low-sodium seasoning (control: regular seasoning', 'Salt Restriction via Home Dishes']","['24-hour urinary sodium excretions', 'Urinary sodium excretion', 'salt intake']","[{'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0453399', 'cui_str': 'Soup'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0012169', 'cui_str': 'Low sodium diet'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0020498', 'cui_str': 'Disseminated idiopathic skeletal hyperostosis'}]","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",195.0,0.0944828,Urinary sodium excretion decreased in both intervention and control groups after the intervention.,"[{'ForeName': 'Sachiko', 'Initials': 'S', 'LastName': 'Maruya', 'Affiliation': ""Department of Food Science and Nutrition, Faculty of Human Life and Environment, Nara Women's University, Kitauoya-Nishimachi, Nara 630-8506, Japan.""}, {'ForeName': 'Ribeka', 'Initials': 'R', 'LastName': 'Takachi', 'Affiliation': ""Department of Food Science and Nutrition, Faculty of Human Life and Environment, Nara Women's University, Kitauoya-Nishimachi, Nara 630-8506, Japan.""}, {'ForeName': 'Maki', 'Initials': 'M', 'LastName': 'Kanda', 'Affiliation': ""Department of Food Science and Nutrition, Faculty of Human Life and Environment, Nara Women's University, Kitauoya-Nishimachi, Nara 630-8506, Japan.""}, {'ForeName': 'Misako', 'Initials': 'M', 'LastName': 'Nakadate', 'Affiliation': 'Department of Food and Life Science, Azabu University, 1-17-71 Fuchinobe, Chuo-ku, Sagamihara-city 252-5201, Kanagawa, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Ishihara', 'Affiliation': 'Department of Food and Life Science, Azabu University, 1-17-71 Fuchinobe, Chuo-ku, Sagamihara-city 252-5201, Kanagawa, Japan.'}]",Nutrients,['10.3390/nu12103034'] 1525,33022987,Ingestion of Helianthus tuberosus at Breakfast Rather Than at Dinner Is More Effective for Suppressing Glucose Levels and Improving the Intestinal Microbiota in Older Adults.,"To date, nutritional studies have focused on the total intake of dietary fiber rather than intake timing. In this study, we examined the effect of the timing of daily Helianthus tuberosus ingestion on postprandial and 24 h glucose levels, as well as on intestinal microbiota in older adults. In total, 37 healthy older adults (age = 74.9 ± 0.8 years) were recruited. The participants were randomly assigned to either a morning group (MG, n = 18) or an evening group (EG, n = 17). The MG and EG groups were instructed to take Helianthus tuberosus powder (5 g/day) just before breakfast or dinner, respectively, for 1 week after the 1-week control period. The glucose levels of all participants were monitored using a continuous glucose monitoring system throughout the 2 weeks. The intestinal microbiota was analyzed by sequencing 16S rRNA genes from feces before and after the intervention. There were no significant differences in the physical characteristics or energy intake between groups. Helianthus tuberosus intake led to decreases in tissue glucose levels throughout the day in both groups ( p < 0.01, respectively). As a result of examining the fluctuations in tissue glucose levels up to 4 hours after each meal, significant decreases in the areas under the curves (AUCs) were observed for all three meals after intervention, but only in the MG (breakfast: p = 0.012, lunch: p = 0.002, dinner: p = 0.005). On the other hand, in the EG, there was a strong decrease in the AUC after dinner, but only slight decreases after breakfast and lunch (breakfast: p = 0.017, lunch: p = 0.427, dinner: p = 0.002). Moreover, the rate of change in the peak tissue glucose level at breakfast was significantly decreased in the MG compared to the EG ( p = 0.027). A greater decrease was observed in the change in the blood glucose level after the ingestion of Helianthus tuberosus in the MG than in the EG. Furthermore, the relative abundance of Ruminococcus in the MG at the genus level was significantly higher at baseline than in the EG ( p = 0.016) and it was also significantly lower after the intervention ( p = 0.013). Our findings indicate that Helianthus tuberosus intake in the morning might have relatively stronger effects on the intestinal microbiota and suppress postprandial glucose levels to a greater extent than when taken in the evening.",2020,"Helianthus tuberosus intake led to decreases in tissue glucose levels throughout the day in both groups ( p < 0.01, respectively).","['older adults', '37 healthy older adults (age = 74.9 ± 0.8 years) were recruited', 'Older Adults']","['morning group (MG, n = 18) or an evening group (EG, n = 17', 'Ingestion of Helianthus tuberosus at Breakfast']","['rate of change in the peak tissue glucose level at breakfast', 'glucose levels', 'postprandial glucose levels', 'blood glucose level', 'relative abundance of Ruminococcus', 'tissue glucose levels', 'intestinal microbiota', 'postprandial and 24 h glucose levels', 'physical characteristics or energy intake']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0022386', 'cui_str': 'Jerusalem artichoke'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0318074', 'cui_str': 'Ruminococcus'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",37.0,0.0193183,"Helianthus tuberosus intake led to decreases in tissue glucose levels throughout the day in both groups ( p < 0.01, respectively).","[{'ForeName': 'Hyeon-Ki', 'Initials': 'HK', 'LastName': 'Kim', 'Affiliation': 'Faculty of Science and Engineering, Waseda University, 2-2 Wakamatsu-cho, Shinjuku, Tokyo 162-8480, Japan.'}, {'ForeName': 'Hanako', 'Initials': 'H', 'LastName': 'Chijiki', 'Affiliation': 'Graduate School of Advanced Science and Engineering, Waseda University, 2-2 Wakamatsu-cho Shinjuku, Tokyo 1628480, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Nanba', 'Affiliation': 'Graduate School of Advanced Science and Engineering, Waseda University, 2-2 Wakamatsu-cho Shinjuku, Tokyo 1628480, Japan.'}, {'ForeName': 'Mamiho', 'Initials': 'M', 'LastName': 'Ozaki', 'Affiliation': 'Graduate School of Advanced Science and Engineering, Waseda University, 2-2 Wakamatsu-cho Shinjuku, Tokyo 1628480, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Sasaki', 'Affiliation': 'Faculty of Science and Engineering, Waseda University, 2-2 Wakamatsu-cho, Shinjuku, Tokyo 162-8480, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Institute for Liberal Arts, Tokyo Institute of Technology, 2-12-1, Ookayama Meguro-ku, Tokyo 152-8550, Japan.'}, {'ForeName': 'Shigenobu', 'Initials': 'S', 'LastName': 'Shibata', 'Affiliation': 'Faculty of Science and Engineering, Waseda University, 2-2 Wakamatsu-cho, Shinjuku, Tokyo 162-8480, Japan.'}]",Nutrients,['10.3390/nu12103035'] 1526,33022991,An Almond-Based Low Carbohydrate Diet Improves Depression and Glycometabolism in Patients with Type 2 Diabetes through Modulating Gut Microbiota and GLP-1: A Randomized Controlled Trial.,"BACKGROUND Alow carbohydrate diet (LCD) is more beneficial for the glycometabolism in type 2 diabetes (T2DM) and may be effective in reducing depression. Almond, which is a common nut, has been shown to effectively improve hyperglycemia and depression symptoms. This study aimed to determine the effect of an almond-based LCD (a-LCD) on depression and glycometabolism, as well as gut microbiota and fasting glucagon-like peptide 1 (GLP-1) in patients with T2DM. METHODS This was a randomized controlled trial which compared an a-LCD with a low-fat diet (LFD). Forty-five participants with T2DM at a diabetes club and the Endocrine Division of the First and Second Affiliated Hospital of Soochow University between December 2018 to December 2019 completed each dietary intervention for 3 months, including 22 in the a-LCD group and 23 in the LFD group. The indicators for depression and biochemical indicators including glycosylated hemoglobin (HbA1c), gut microbiota, and GLP-1 concentration were assessed at the baseline and third month and compared between the two groups. RESULTS A-LCD significantly improved depression and HbA1c ( p <0.01). Meanwhile, a-LCD significantly increased the short chain fatty acid (SCFAs)-producing bacteria Roseburia , Ruminococcus and Eubacterium . The GLP-1 concentration in the a-LCD group was higher than that in the LFD group ( p <0.05). CONCLUSIONS A-LCD could exert a beneficial effect on depression and glycometabolism in patients with T2DM. We speculate that the role of a-LCD in improving depression in patients with T2DM may be associated with it stimulating the growth of SCFAs-producing bacteria, increasing SCFAs production and GPR43 activation, and further maintaining GLP-1 secretion. In future studies, the SCFAs and GPR43 activation should be further examined.",2020,A-LCD significantly improved depression and HbA1c ( p <0.01).,"['Affiliated Hospital of Soochow University between December 2018 to December 2019 completed each dietary intervention for 3 months, including 22 in the a-LCD group and 23 in the LFD group', 'Forty-five participants with T2DM at a diabetes club and the Endocrine Division of the First and Second', 'Patients with Type 2 Diabetes through Modulating Gut Microbiota and GLP-1', 'patients with T2DM']","['LFD', 'LCD with a low-fat diet (LFD', 'Almond-Based Low Carbohydrate Diet', 'almond-based LCD (a-LCD', 'Alow carbohydrate diet (LCD']","['hyperglycemia and depression symptoms', 'glycosylated hemoglobin (HbA1c), gut microbiota, and GLP-1 concentration', 'GLP-1 concentration', 'depression and HbA1c', 'short chain fatty acid (SCFAs)-producing bacteria Roseburia , Ruminococcus and Eubacterium ']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0440286', 'cui_str': 'Almond'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1690006', 'cui_str': 'Lattice corneal dystrophy Type I'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}]","[{'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C1690006', 'cui_str': 'Lattice corneal dystrophy Type I'}, {'cui': 'C0440286', 'cui_str': 'Almond'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0259836', 'cui_str': 'Carbohydrate restricted diet'}, {'cui': 'C0301577', 'cui_str': 'Carbohydrate diet'}]","[{'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0995401', 'cui_str': 'Roseburia'}, {'cui': 'C0318074', 'cui_str': 'Ruminococcus'}, {'cui': 'C0015146', 'cui_str': 'Eubacterium'}]",45.0,0.0354016,A-LCD significantly improved depression and HbA1c ( p <0.01).,"[{'ForeName': 'Mengxiao', 'Initials': 'M', 'LastName': 'Ren', 'Affiliation': 'School of Nursing, Medical College, Soochow University, Suzhou 215006, China.'}, {'ForeName': 'Huaiyu', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'School of Medicine, University of California, San Francisco, CA 94110, USA.'}, {'ForeName': 'Jindan', 'Initials': 'J', 'LastName': 'Qi', 'Affiliation': 'School of Nursing, Medical College, Soochow University, Suzhou 215006, China.'}, {'ForeName': 'Anni', 'Initials': 'A', 'LastName': 'Hu', 'Affiliation': 'School of Nursing, Medical College, Soochow University, Suzhou 215006, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': 'School of Nursing, Medical College, Soochow University, Suzhou 215006, China.'}, {'ForeName': 'Yunying', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': 'School of Nursing, Medical College, Soochow University, Suzhou 215006, China.'}, {'ForeName': 'Qianqian', 'Initials': 'Q', 'LastName': 'Feng', 'Affiliation': 'School of Nursing, Medical College, Soochow University, Suzhou 215006, China.'}, {'ForeName': 'Omorogieva', 'Initials': 'O', 'LastName': 'Ojo', 'Affiliation': 'School of Health Sciences, Faculty of Education, Health and Human Sciences, University of Greenwich, London SE9 2UG, UK.'}, {'ForeName': 'Xiaohua', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Medical College, Soochow University, Suzhou 215006, China.'}]",Nutrients,['10.3390/nu12103036'] 1527,33024552,Green tea influence on iron overload in thalassemia intermedia patients: a randomized controlled trial.,"Background: Although iron chelation therapies have been available for many years for thalassemia intermedia patients, iron accumulation remains the major cause of death. Therefore, the need for additional chelation options is in demand. This randomized controlled study aimed to understand the effects of green tea on iron balance in thalassemia intermedia patients. Methods: Using a random selection method, 141 thalassemia intermedia patients were initially screened for inclusion in this trial; only 68 patients included after applying exclusion criteria. Two equal groups were generated (n=34/group): green tea (three cups/day after meals) + usual treatment (deferasirox iron chelator and on demand blood transfusion); and control (only usual treatment). The study lasted for a period of 12 months. Patients failing to comply to the trial methodology were excluded, leaving a final total of 29 patients in the green tea group and 28 patients in the control group. Liver iron concentration, and serum ferritin were assessed at baseline and 12 months, while hemoglobin levels were assessed monthly. Results: At baseline, both groups were matched regarding general demographics. At 12 months, the net drop of liver iron concentration in the green tea group (7.3 mg Fe/g dry weight) was significantly higher than the control group (4.6 mg Fe/g dry weight) (p<0.05). This was also seen with serum ferritin; net reduction in green tea and control groups were 1289 ng/ml and 871 ng/ml, respectively (p<0.05). Hemoglobin levels were slightly higher in the green tea group compared with the control group, but this was not significant. Conclusions: Regular green tea consumption had a significant capability to improve iron deposition in thalassemia intermedia patients who already undergo deferesirox iron chelation therapy. Trial registration: UMIN-CTR Clinical Trials Registry, UMIN000040841 (retrospectively registered June 21, 2020).",2020,"Hemoglobin levels were slightly higher in the green tea group compared with the control group, but this was not significant. ","['Patients failing to comply to the trial methodology were excluded, leaving a final total of 29 patients in the green tea group and 28 patients in the control group', 'thalassemia intermedia patients who already undergo deferesirox iron chelation therapy', '141 thalassemia intermedia patients were initially screened for inclusion in this trial; only 68 patients included after applying exclusion criteria', 'thalassemia intermedia patients']","['Green tea', 'Regular green tea consumption', 'green tea (three cups/day after meals) + usual treatment (deferasirox iron chelator and on demand blood transfusion); and control (only usual treatment', 'green tea']","['hemoglobin levels', 'Hemoglobin levels', 'liver iron concentration', 'iron deposition', 'serum ferritin; net reduction', 'Liver iron concentration, and serum ferritin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0969625', 'cui_str': 'methodology'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1384640', 'cui_str': 'Green tea'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0271979', 'cui_str': 'Thalassemia intermedia'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0007975', 'cui_str': 'Chelation therapy'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1384640', 'cui_str': 'Green tea'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1619629', 'cui_str': 'deferasirox'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0007974', 'cui_str': 'Chelating agent'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0333596', 'cui_str': 'Deposition of iron'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.174387,"Hemoglobin levels were slightly higher in the green tea group compared with the control group, but this was not significant. ","[{'ForeName': 'Hayder', 'Initials': 'H', 'LastName': 'Al-Momen', 'Affiliation': 'Department of Pediatrics, Al-Kindy College of Medicine, University of Baghdad, Baghdad, 00964, Iraq.'}, {'ForeName': 'Hussein Khudhair', 'Initials': 'HK', 'LastName': 'Hussein', 'Affiliation': 'Department of Pediatrics, Al-Kindy College of Medicine, University of Baghdad, Baghdad, 00964, Iraq.'}, {'ForeName': 'Zaid', 'Initials': 'Z', 'LastName': 'Al-Attar', 'Affiliation': 'Department of Pharmacology, Al-Kindy College of Medicine, University of Baghdad, Baghdad, 00964, Iraq.'}, {'ForeName': 'Mohammed Jalal', 'Initials': 'MJ', 'LastName': 'Hussein', 'Affiliation': 'Department of Pediatrics, Al-Kindy College of Medicine, University of Baghdad, Baghdad, 00964, Iraq.'}]",F1000Research,['10.12688/f1000research.25553.1'] 1528,33027214,Acute Ketogenic Diet and Ketone Ester Supplementation Impairs Race Walk Performance.,"PURPOSE This study aimed to determine if LCHF and ketone ester (KE) supplementation can synergistically alter exercise metabolism and improve performance. METHODS Elite race walkers (n = 18, 15 males and 3 females; V˙O2peak, 62 ± 6 mL·min-1·kg-1) undertook a four-stage exercise economy test and real-life 10,000-m race before and after a 5-d isoenergetic high-CHO (HCHO, ~60%-65% fat; CHO, 20% fat; n = 9) or LCHF (75%-80% fat, <50 g·d-1 CHO, n = 9) diet. The LCHF group performed additional economy tests before and after diet after supplementation with 573 mg·kg-1 body mass KE (HVMN; HVMN Inc., San Francisco, CA), which was also consumed for race 2. RESULTS The oxygen cost of exercise (relative V˙O2, mL·min-1·kg-1) increased across all four stages after LCHF (P < 0.005). This occurred in association with increased fat oxidation rates, with a reciprocal decrease in CHO oxidation (P < 0.001). Substrate utilization in the HCHO group remained unaltered. The consumption of KE before the LCHF diet increased circulating KB (P < 0.05), peaking at 3.2 ± 0.6 mM, but did not alter V˙O2 or RER. LCHF diet elevated resting circulating KB (0.3 ± 0.1 vs 0.1 ± 0.1 mM), but concentrations after supplementation did not differ from the earlier ketone trial. Critically, race performance was impaired by ~6% (P < 0.0001) relative to baseline in the LCHF group but was unaltered in HCHO. CONCLUSION Despite elevating endogenous KB production, an LCHF diet does not augment the metabolic responses to KE supplementation and negatively affects race performance.",2021,"Critically, race performance was impaired by ~6% (p<0.0001) relative to baseline in the LCHF group but was unaltered in HCHO. ","['Elite race walkers ', 'n=18, 15 male, 3 female']","['ketogenic low-carbohydrate (CHO), high-fat (LCHF) diet', 'V[Combining', 'LCHF', 'LCHF and KE supplementation', 'Acute Ketogenic Diet and Ketone Ester Supplementation']","['Substrate utilisation', 'V[Combining Dot Above]O2 or RER', 'race performance', 'circulating KB', 'oxygen cost of exercise (relative V[Combining', 'Race Walk Performance', 'fat oxidation rates', 'CHO oxidation', 'exercise metabolism and improve performance', 'endogenous KB production', 'Dot Above]O2, mL·min·kg']","[{'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0043016', 'cui_str': 'Walker'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0014898', 'cui_str': 'Ester'}]","[{'cui': 'C1720485', 'cui_str': 'Corneal epithelial dots'}, {'cui': 'C0230779', 'cui_str': 'Granular endoplasmic reticulum'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0022631', 'cui_str': 'Ketone body'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}]",,0.0320921,"Critically, race performance was impaired by ~6% (p<0.0001) relative to baseline in the LCHF group but was unaltered in HCHO. ","[{'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Whitfield', 'Affiliation': 'Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, VIC, AUSTRALIA.'}, {'ForeName': 'Louise M', 'Initials': 'LM', 'LastName': 'Burke', 'Affiliation': ''}, {'ForeName': 'Alannah K A', 'Initials': 'AKA', 'LastName': 'McKay', 'Affiliation': ''}, {'ForeName': 'Ida A', 'Initials': 'IA', 'LastName': 'Heikura', 'Affiliation': ''}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Hall', 'Affiliation': 'Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, VIC, AUSTRALIA.'}, {'ForeName': 'Nikita', 'Initials': 'N', 'LastName': 'Fensham', 'Affiliation': 'Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, VIC, AUSTRALIA.'}, {'ForeName': 'Avish P', 'Initials': 'AP', 'LastName': 'Sharma', 'Affiliation': 'Griffith Sports Physiology and Performance, Griffith University, Gold Coast, QLD, AUSTRALIA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002517'] 1529,33028623,Randomized trial of primary debulking surgery versus neoadjuvant chemotherapy for advanced epithelial ovarian cancer (SCORPION-NCT01461850).,"OBJECTIVE To investigate whether neoadjuvant chemotherapy followed by interval debulking surgery is superior to primary debulking surgery in terms of perioperative complications and progression-free survival, in advanced epithelial ovarian, fallopian tube or primary peritoneal cancer patients with high tumor load. METHODS Patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer (stage IIIC-IV) underwent laparoscopy. Patients with high tumor load assessed by a standardized laparoscopic predictive index were randomly assigned (1:1 ratio) to undergo either primary debulking surgery followed by adjuvant chemotherapy (arm A), or neoadjuvant chemotherapy followed by interval debulking surgery and adjuvant chemotherapy (arm B). Co-primary outcome measures were progression-free survival and post-operative complications; secondary outcomes were overall survival, and quality of life. Survival analyses were performed on an intention-to-treat population. RESULTS 171 patients were randomly assigned to primary debulking surgery (n=84) versus neoadjuvant chemotherapy (n=87). Rates of complete resection (R0) were different between the arms (47.6% in arm A vs 77.0% in arm B; p=0.001). 53 major postoperative complications were registered, mainly distributed in arm A compared with arm B (25.9% vs 7.6%; p=0.0001). All patients were included in the intent-to-treat analysis. With an overall median follow-up of 59 months (95% CI 53 to 64), 142 (83.0%) disease progressions/recurrences and 103 deaths (60.2%) occurred. Median progression-free and overall survival were 15 and 41 months for patients assigned to primary debulking surgery, compared with 14 and 43 months for patients assigned to neoadjuvant chemotherapy, respectively (HR 1.05, 95% CI 0.77 to 1.44, p=0.73; HR 1.12, 95% CI 0.76 to 1.65, p=0.56). CONCLUSIONS Neoadjuvant chemotherapy and primary debulking surgery have the same efficacy when used at their maximal possibilities, but the toxicity profile is different.",2020,"Median progression-free and overall survival were 15 and 41 months for patients assigned to primary debulking surgery, compared with 14 and 43 months for patients assigned to neoadjuvant chemotherapy, respectively (HR 1.05, 95% CI 0.77 to 1.44, p=0.73; HR 1.12, 95% CI 0.76 to 1.65, p=0.56). ","['Patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer (stage IIIC-IV) underwent laparoscopy', '171 patients', 'advanced epithelial ovarian, fallopian tube or primary peritoneal cancer patients with high tumor load', 'Patients with high tumor load assessed by a standardized laparoscopic predictive index']","['primary debulking surgery', 'primary debulking surgery versus neoadjuvant chemotherapy', 'primary debulking surgery followed by adjuvant chemotherapy (arm A), or neoadjuvant chemotherapy followed by interval debulking surgery and adjuvant chemotherapy (arm B', 'neoadjuvant chemotherapy followed by interval debulking surgery', 'neoadjuvant chemotherapy']","['progression-free survival and post-operative complications; secondary outcomes were overall survival, and quality of life', 'Median progression-free and overall survival', 'disease progressions/recurrences and 103 deaths', 'toxicity profile', 'advanced epithelial ovarian cancer', '53 major postoperative complications', 'Rates of complete resection (R0']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0015560', 'cui_str': 'Fallopian tube structure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0153467', 'cui_str': 'Malignant tumor of peritoneum'}, {'cui': 'C0456608', 'cui_str': 'Stage 3C'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1449699', 'cui_str': 'Tumor Load'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0015250', 'cui_str': 'Complete excision'}]",171.0,0.400373,"Median progression-free and overall survival were 15 and 41 months for patients assigned to primary debulking surgery, compared with 14 and 43 months for patients assigned to neoadjuvant chemotherapy, respectively (HR 1.05, 95% CI 0.77 to 1.44, p=0.73; HR 1.12, 95% CI 0.76 to 1.65, p=0.56). ","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Fagotti', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy annafagotti70@gmail.com.'}, {'ForeName': 'Maria Gabriella', 'Initials': 'MG', 'LastName': 'Ferrandina', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Vizzielli', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Pasciuto', 'Affiliation': 'Statistics Technology Archiving Research (STAR) Center, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Fanfani', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'Gallotta', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Pasquale Alessandro', 'Initials': 'PA', 'LastName': 'Margariti', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Vito', 'Initials': 'V', 'LastName': 'Chiantera', 'Affiliation': 'Department of Gynecologic Oncology, ARNAS Civico Di Cristina Benfratelli, Palermo, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Costantini', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Gueli Alletti', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cosentino', 'Affiliation': 'Gynecologic Oncology, Gemelli Molise spa, Università Cattolica del Sacro Cuore, Campobasso, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001640'] 1530,33032927,Preliminary Evidence That Cortical Amyloid Burden Predicts Poor Response to Antidepressant Medication Treatment in Cognitively Intact Individuals With Late-Life Depression.,"OBJECTIVE Amyloid accumulation, the pathological hallmark of Alzheimer's disease, may predispose some older adults to depression and cognitive decline. Deposition of amyloid also occurs prior to the development of cognitive decline. It is unclear whether amyloid influences antidepressant outcomes in cognitively intact depressed elders. DESIGN A pharmacoimaging trial utilizing florbetapir (18F) PET scanning followed by 2 sequential 8-week antidepressant medication trials. PARTICIPANTS Twenty-seven depressed elders who were cognitively intact on screening. MEASUREMENTS AND INTERVENTIONS After screening, diagnostic testing, assessment of depression severity and neuropsychological assessment, participants completed florbetapir (18F) PET scanning. They were then randomized to receive escitalopram or placebo for 8 weeks in a double-blinded two-to-one allocation rate. Individuals who did not respond to initial treatment transitioned to a second open-label trial of bupropion for another 8 weeks. RESULTS Compared with 22 amyloid-negative participants, 5 amyloid-positive participants exhibited significantly less change in depression severity and a lower likelihood of remission. In the initial blinded trial, 4 of 5 amyloid-positive participants were nonremitters (80%), while only 18% (4 of 22) of amyloid-negative participants did not remit (p = 0.017; Fisher's Exact test). In separate models adjusting for key covariates, both positive amyloid status (t = 3.07, 21 df, p = 0.003) and higher cortical amyloid binding by standard uptake value ratio (t = 2.62, 21 df, p = 0.010) were associated with less improvement in depression severity. Similar findings were observed when examining change in depression status across both antidepressant trials. CONCLUSIONS In this preliminary study, amyloid status predicted poor antidepressant response to sequential antidepressant treatment. Alternative treatment approaches may be needed for amyloid-positive depressed elders.",2021,"Individuals who did not respond to initial treatment transitioned to a second open-label trial of bupropion for another 8 weeks. ","['Individuals who did not respond to initial treatment transitioned to a second open-label trial of', 'Intact Individuals With Late-Life Depression', 'amyloid-positive depressed elders', 'Twenty-seven depressed elders who were cognitively intact on screening', 'cognitively intact depressed elders', 'Cognitively']","['florbetapir (18F) PET scanning', 'bupropion', 'escitalopram or placebo']","['depression status', 'depression severity and a lower likelihood of remission', 'cortical amyloid binding by standard uptake value ratio', 'depression severity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C2742211', 'cui_str': 'florbetapir'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",27.0,0.194977,"Individuals who did not respond to initial treatment transitioned to a second open-label trial of bupropion for another 8 weeks. ","[{'ForeName': 'Warren D', 'Initials': 'WD', 'LastName': 'Taylor', 'Affiliation': 'The Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences (WDT, BDB, PA, KA, JV, PAN, NDW, HK, SS), Vanderbilt University Medical Center, Nashville, TN; Geriatric Research, Education, and Clinical Center (WDT, PAN), Veterans Affairs Tennessee Valley Health System, Nashville, TN. Electronic address: warren.d.taylor@vanderbilt.edu.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Boyd', 'Affiliation': 'The Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences (WDT, BDB, PA, KA, JV, PAN, NDW, HK, SS), Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Elson', 'Affiliation': 'The Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences (WDT, BDB, PA, KA, JV, PAN, NDW, HK, SS), Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Andrews', 'Affiliation': 'The Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences (WDT, BDB, PA, KA, JV, PAN, NDW, HK, SS), Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Albert', 'Affiliation': 'The Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences (WDT, BDB, PA, KA, JV, PAN, NDW, HK, SS), Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Vega', 'Affiliation': 'The Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences (WDT, BDB, PA, KA, JV, PAN, NDW, HK, SS), Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Newhouse', 'Affiliation': 'The Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences (WDT, BDB, PA, KA, JV, PAN, NDW, HK, SS), Vanderbilt University Medical Center, Nashville, TN; Geriatric Research, Education, and Clinical Center (WDT, PAN), Veterans Affairs Tennessee Valley Health System, Nashville, TN.'}, {'ForeName': 'Neil D', 'Initials': 'ND', 'LastName': 'Woodward', 'Affiliation': 'The Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences (WDT, BDB, PA, KA, JV, PAN, NDW, HK, SS), Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Hakmook', 'Initials': 'H', 'LastName': 'Kang', 'Affiliation': 'Department of Biostatistics (HK), Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Shokouhi', 'Affiliation': 'The Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences (WDT, BDB, PA, KA, JV, PAN, NDW, HK, SS), Vanderbilt University Medical Center, Nashville, TN.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.09.019'] 1531,33034421,"An open-label, randomized crossover study to evaluate the acceptability and preference for contraceptive options in female adolescents, 15 to 19 years of age in Cape Town, as a proxy for HIV prevention methods (UChoose).","INTRODUCTION Young women in Southern Africa have extremely high HIV incidence rates necessitating the availability of female-controlled prevention methods. Understanding adolescent preference for seeking contraception would improve our understanding of acceptability, feasibility and adherence to similar modes of delivery for HIV prevention. METHODS UChoose was an open-label randomized crossover study over 32 weeks which aimed to evaluate the acceptability and preference for contraceptive options in healthy, HIV-uninfected, female adolescents aged 15 to 19 years, as a proxy for similar HIV prevention methods. Participants were assigned to a contraceptive method for a period of 16 weeks in the form of a bi-monthly injectable contraceptive, monthly vaginal Nuvaring ® or daily combined oral contraceptive (COC) and then asked to state their preference. At 16 weeks, participants crossed over to another contraceptive method, to ensure that all participants tried the Nuvaring ® (least familiar modality) and additionally, either the injection or COC. Primary outcomes were contraceptive acceptability and preference. At the end of the 32 weeks they were also asked to imagine their preference for an HIV prevention modality. Secondary endpoints included changes in sexual behaviour, contraceptive adherence and preference for biomedical and behavioural HIV prevention methods. RESULTS Of the 180 participants screened, 130 were enrolled and randomized to the Nuvaring ® (n = 45), injection (n = 45) or COC (n = 40). Significantly more Nuvaring ® users (24/116; 20.7%) requested to change to another contraceptive option compared to injection (1/73; 1.4% p = 0.0002) and COC users (4/49; 8% p = 0.074). Of those that remained on the Nuvaring ® , adherence was significantly higher than to COC (p < 0.0001). Significantly more injection users (77/80; 96.3%) thought this delivery mode was convenient to use compared to Nuvaring ® (74/89; 83.1%; p = 0.0409) or COC (38/50; 76.0%; p = 0.0034). Overall, the preferred contraceptive choice was injection, followed by the ring and lastly the pill. CONCLUSIONS Adherence to daily COC was difficult for adolescents in this cohort and the least favoured potential HIV prevention option. While some preferred vaginal ring use, these data suggest that long-acting injectables would be the preferred prevention method for adolescent girls and young women. This study highlights the need for additional options for HIV prevention in youth.",2020,Significantly more injection users (77/80; 96.3%) thought this delivery mode was convenient to use compared to Nuvaring ® (74/89; 83.1%; p = 0.0409) or COC (38/50; 76.0%; p = 0.0034).,"['Young women in Southern Africa', 'HIV prevention in youth', 'female adolescents, 15 to 19 years of age in Cape Town, as a proxy for HIV prevention methods (UChoose', '180 participants screened, 130 were enrolled and randomized to the Nuvaring ® (n\xa0=\xa045), injection (n\xa0=\xa045) or', 'healthy, HIV-uninfected, female adolescents aged 15 to 19\xa0years, as a proxy for similar HIV prevention methods', 'adolescent girls and young women']","['COC', 'bi-monthly injectable contraceptive, monthly vaginal Nuvaring ® or daily combined oral contraceptive (COC']","['acceptability and preference', 'changes in sexual behaviour, contraceptive adherence and preference for biomedical and behavioural HIV prevention methods', 'contraceptive acceptability and preference']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001746', 'cui_str': 'Southern Africa'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C1744678', 'cui_str': 'NuvaRing'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C1744678', 'cui_str': 'NuvaRing'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009906', 'cui_str': 'Oral Contraceptives, Combined'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",130.0,0.0785338,Significantly more injection users (77/80; 96.3%) thought this delivery mode was convenient to use compared to Nuvaring ® (74/89; 83.1%; p = 0.0409) or COC (38/50; 76.0%; p = 0.0034).,"[{'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Gill', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Anna-Ursula', 'Initials': 'AU', 'LastName': 'Happel', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Pidwell', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Mendelsohn', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Menna', 'Initials': 'M', 'LastName': 'Duyver', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Johnson', 'Affiliation': 'Centre for Infectious Diseases Epidemiology and Research, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Landon', 'Initials': 'L', 'LastName': 'Meyer', 'Affiliation': 'Centre for Infectious Diseases Epidemiology and Research, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Slack', 'Affiliation': 'HIV AIDS Vaccines Ethics Group, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Strode', 'Affiliation': 'HIV AIDS Vaccines Ethics Group, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Eve', 'Initials': 'E', 'LastName': 'Mendel', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Fynn', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Wallace', 'Affiliation': 'Cancer Association of South Africa, Johannesburg, South Africa.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Spiegel', 'Affiliation': 'Department of Health and Human Services, Kelly Government Solutions, Contractor to National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Jaspan', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jo-Ann', 'Initials': 'JA', 'LastName': 'Passmore', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Sybil', 'Initials': 'S', 'LastName': 'Hosek', 'Affiliation': 'Stroger Hospital of Cook County, Chicago, IL, USA.'}, {'ForeName': 'Dionne', 'Initials': 'D', 'LastName': 'Smit', 'Affiliation': 'MSD (Pty) Ltd, Halfway House, South Africa.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Rinehart', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}]",Journal of the International AIDS Society,['10.1002/jia2.25626'] 1532,33036155,"Effects of the Daily Consumption of Stevia on Glucose Homeostasis, Body Weight, and Energy Intake: A Randomised Open-Label 12-Week Trial in Healthy Adults.","Stevia is a non-nutritive sweetener, providing sweet taste with no calories. This randomised, controlled, open-label 2-parallel arm trial examined the effects of daily stevia consumption on glycaemia in healthy adults. Secondary endpoints included body weight (BW) and energy intake (EI). Healthy participants ( n = 28; aged 25 ± 5y, body mass index 21.2 ± 1.7 kg/m 2 ) were randomised into either the stevia group ( n = 14)-required to consume a stevia extract daily-or to the control group ( n = 14). At weeks 0 and 12, the glucose and insulin responses to an oral glucose tolerance test were measured; BW and EI were assessed at weeks 0, 6, and 12. There was no significant difference in the glucose or insulin responses. There was a significant main effect of group on BW change (F(1,26) = 5.56, p = 0.026), as the stevia group maintained their weight as opposed to the control group (mean weight change at week 12: -0.22 kg, 95%CI [-0.96, 0.51] stevia group, +0.89 kg, 95%CI [0.16, 1.63] control group). The energy intake was significantly decreased between week 0 and 12 in the stevia group ( p = 0.003), however no change was found in the control group ( p = 0.973). Although not placebo-controlled, these results suggest that daily stevia consumption does not affect glycaemia in healthy individuals, but could aid in weight maintenance and the moderation of EI.",2020,"The energy intake was significantly decreased between week 0 and 12 in the stevia group ( p = 0.003), however no change was found in the control group ( p = 0.973).","['Healthy Adults', 'healthy individuals', 'healthy adults', 'Healthy participants ( n = 28; aged 25 ± 5y, body mass index 21.2 ± 1.7 kg/m 2 ']","['stevia group ( n = 14)-required to consume a stevia extract daily-or to the control group', 'placebo', 'daily stevia consumption']","['body weight (BW) and energy intake (EI', 'energy intake', 'Glucose Homeostasis, Body Weight, and Energy Intake', 'glucose or insulin responses', 'glucose and insulin responses to an oral glucose tolerance test']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517512', 'cui_str': '1.7'}]","[{'cui': 'C0075246', 'cui_str': 'stevioside'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]",28.0,0.0416548,"The energy intake was significantly decreased between week 0 and 12 in the stevia group ( p = 0.003), however no change was found in the control group ( p = 0.973).","[{'ForeName': 'Nikoleta S', 'Initials': 'NS', 'LastName': 'Stamataki', 'Affiliation': 'Division of Diabetes, Endocrinology & Gastroenterology, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences Centre, The University of Manchester, Oxford Rd, Manchester M13 9PL, UK.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Crooks', 'Affiliation': 'Division of Diabetes, Endocrinology & Gastroenterology, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences Centre, The University of Manchester, Oxford Rd, Manchester M13 9PL, UK.'}, {'ForeName': 'Abubaker', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Division of Diabetes, Endocrinology & Gastroenterology, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences Centre, The University of Manchester, Oxford Rd, Manchester M13 9PL, UK.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'McLaughlin', 'Affiliation': 'Division of Diabetes, Endocrinology & Gastroenterology, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences Centre, The University of Manchester, Oxford Rd, Manchester M13 9PL, UK.'}]",Nutrients,['10.3390/nu12103049'] 1533,33041071,Near-infrared fluorescence imaging compared to standard sentinel lymph node detection with blue dye in patients with vulvar cancer - a randomized controlled trial.,"OBJECTIVE The aim of this study was to assess the superiority of ICG- 99m Tc-nanocolloid for the intraoperative visual detection of sentinel lymph nodes (SLNs) in vulvar squamous cell carcinoma (VSCC) patients compared to standard SLN detection using 99m Tc-nanocolloid with blue dye. METHODS In this multicenter, randomized controlled trial, VSCC patients underwent either the standard SLN procedure or with the hybrid tracer ICG- 99m Tc-nanocolloid. The primary endpoint was the percentage of fluorescent SLNs compared to blue SLNs. Secondary endpoints were successful SLN procedures, surgical outcomes and postoperative complications. RESULTS Forty-eight patients were randomized to the standard (n = 24) or fluorescence imaging group (n = 24) using ICG- 99m Tc-nanocolloid. The percentage of blue SLNs was 65.3% compared to 92.5% fluorescent SLNs (p < 0.001). A successful SLN procedure was obtained in 92.1% of the groins in the standard group and 97.2% of the groins in the fluorescence imaging group (p = 0.33). Groups did not differ in surgical outcome, although more short-term postoperative complications were documented in the standard group (p = 0.041). CONCLUSIONS Intraoperative visual detection of SLNs in patients with VSCC using ICG- 99m Tc-nanocolloid was superior compared to 99m Tc-nanocolloid and blue dye. The rate of successful SLN procedures between both groups was not significantly different. Fluorescence imaging has potential to be used routinely in the SLN procedure in VSCC patients to facilitate the search by direct visualization. CLINICAL TRIAL REGISTRATION Netherlands Trial Register (Trial ID NL7443).",2020,The rate of successful SLN procedures between both groups was not significantly different.,"['patients with vulvar cancer', 'Forty-eight patients', 'vulvar squamous cell carcinoma (VSCC) patients']","['standard SLN detection using 99m Tc-nanocolloid with blue dye', 'VSCC', 'ICG- 99m Tc-nanocolloid', 'standard SLN procedure or with the hybrid tracer ICG- 99m Tc-nanocolloid', 'fluorescence imaging']","['percentage of fluorescent SLNs', 'short-term postoperative complications', 'successful SLN procedures, surgical outcomes and postoperative complications', 'percentage of blue SLNs', 'rate of successful SLN procedures']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0375071', 'cui_str': 'Malignant tumor of vulva'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0280856', 'cui_str': 'Squamous cell carcinoma of vulva'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0303611', 'cui_str': 'Technetium 99m'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0013343', 'cui_str': 'Dye'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0430876', 'cui_str': 'Ophthalmic fluorescence imaging'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0303920', 'cui_str': 'Fluorescent stain'}, {'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}]",48.0,0.105615,The rate of successful SLN procedures between both groups was not significantly different.,"[{'ForeName': 'Marion M', 'Initials': 'MM', 'LastName': 'Deken', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Helena C', 'Initials': 'HC', 'LastName': 'van Doorn', 'Affiliation': 'Department of Gynecologic Oncology, Erasmus MC Cancer Institute, Erasmus University Medical Center Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Verver', 'Affiliation': 'Department of Surgery, Erasmus MC Cancer Institute, Erasmus University Medical Center Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Leonora S F', 'Initials': 'LSF', 'LastName': 'Boogerd', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Kim S', 'Initials': 'KS', 'LastName': 'de Valk', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Daphne D D', 'Initials': 'DDD', 'LastName': 'Rietbergen', 'Affiliation': 'Department of Radiology, Section Nuclear Medicine, Leiden University Medical Center, Leiden, the Netherlands; Interventional Molecular Imaging Laboratory, Department of Radiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Mariëtte I E', 'Initials': 'MIE', 'LastName': 'van Poelgeest', 'Affiliation': 'Department of Gynecology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Cor D', 'Initials': 'CD', 'LastName': 'de Kroon', 'Affiliation': 'Department of Gynecology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Jogchum J', 'Initials': 'JJ', 'LastName': 'Beltman', 'Affiliation': 'Department of Gynecology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Fijs W B', 'Initials': 'FWB', 'LastName': 'van Leeuwen', 'Affiliation': 'Interventional Molecular Imaging Laboratory, Department of Radiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Department of Medical Statistics, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Jeffrey P B M', 'Initials': 'JPBM', 'LastName': 'Braak', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Lioe-Fee', 'Initials': 'LF', 'LastName': 'de Geus-Oei', 'Affiliation': 'Department of Radiology, Section Nuclear Medicine, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Cock J H', 'Initials': 'CJH', 'LastName': 'van de Velde', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Jacobus', 'Initials': 'J', 'LastName': 'Burggraaf', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'Alexander L', 'Initials': 'AL', 'LastName': 'Vahrmeijer', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Katja N', 'Initials': 'KN', 'LastName': 'Gaarenstroom', 'Affiliation': 'Department of Gynecology, Leiden University Medical Center, Leiden, the Netherlands. Electronic address: K.N.Gaarenstroom@lumc.nl.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.09.044'] 1534,33044249,Allogeneic Platelet-Rich Plasma Versus Corticosteroid Injection for the Treatment of Rotator Cuff Disease: A Randomized Controlled Trial.,"BACKGROUND The use of platelet-rich plasma (PRP) for the treatment of rotator cuff disease is still controversial. The purpose of the present study was to investigate the safety and efficacy of a fully characterized allogeneic pure PRP injection into the subacromial space of patients with rotator cuff disease in comparison with corticosteroid injection. METHODS A 2-group, parallel, assessor-blinded, randomized controlled trial was conducted. A total of 60 patients with clinically and structurally diagnosed rotator cuff disease were randomly assigned to receive a subacromial injection of either 4 mL of allogeneic pure PRP or a 4-mL mixture of 1 mL of 40-mg/mL triamcinolone acetonide and 3 mL of 2% lidocaine under ultrasonographic guidance. The primary outcomes were safety and the Constant score at 1 month. The secondary outcomes were pain, range of motion, muscle strength, functional scores, and overall satisfaction and function. RESULTS There were no treatment-related adverse events. The Constant score at 1 month did not significantly differ between the PRP and corticosteroid groups. At 6 months, the DASH (Disabilities of the Arm, Shoulder and Hand) score, overall function, and external rotation were significantly better in the PRP group than in the corticosteroid group, and the other clinical outcomes did not show significant differences. All pain measurements, the strength of the supraspinatus and infraspinatus, and 5 functional scores also improved slowly and steadily after injection, becoming significantly better at 6 months compared with those before the injection, whereas those in the corticosteroid group responded promptly but did not further improve. CONCLUSIONS Allogeneic PRP injections for the treatment of rotator cuff disease are safe but are not definitely superior to corticosteroid injections with respect to pain relief and functional improvement during 6 months. The DASH score, overall function, and external rotation were significantly better in the PRP group than in the steroid group at 6 months. Generally, PRP slowly but steadily reduced pain and improved function of the shoulder until 6 months, whereas corticosteroid did not. LEVEL OF EVIDENCE Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"The DASH score, overall function, and external rotation were significantly better in the PRP group than in the steroid group at 6 months.","['60 patients with clinically and structurally diagnosed rotator cuff disease', 'patients with rotator cuff disease in comparison with corticosteroid injection', 'Rotator Cuff Disease']","['platelet-rich plasma (PRP', 'PRP', 'subacromial injection of either 4 mL of allogeneic pure PRP or a 4-mL mixture of 1 mL of 40-mg/mL triamcinolone acetonide and 3 mL of 2% lidocaine', 'Allogeneic PRP injections', 'Allogeneic Platelet-Rich Plasma Versus Corticosteroid Injection', 'fully characterized allogeneic pure PRP injection']","['pain relief and functional improvement', 'DASH score, overall function, and external rotation', 'safety and efficacy', 'DASH (Disabilities of the Arm, Shoulder and Hand) score, overall function, and external rotation', 'adverse events', 'pain, range of motion, muscle strength, functional scores, and overall satisfaction and function', 'Constant score', 'safety and the Constant score', 'pain and improved function', 'All pain measurements, the strength of the supraspinatus and infraspinatus, and 5 functional scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0584869', 'cui_str': 'Supraspinatus muscle structure'}, {'cui': 'C0584882', 'cui_str': 'Infraspinatus muscle structure'}]",60.0,0.109834,"The DASH score, overall function, and external rotation were significantly better in the PRP group than in the steroid group at 6 months.","[{'ForeName': 'Chris Hyunchul', 'Initials': 'CH', 'LastName': 'Jo', 'Affiliation': 'Departments of Orthopedic Surgery (C.H.J., S.Y.L., and K.S.Y.), Biostatistics (S.O.), and Laboratory Medicine (S.S.), SMG-SNU Boramae Medical Center, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seung Yeon', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Kang Sup', 'Initials': 'KS', 'LastName': 'Yoon', 'Affiliation': ''}, {'ForeName': 'Sohee', 'Initials': 'S', 'LastName': 'Oh', 'Affiliation': ''}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Shin', 'Affiliation': ''}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.01411'] 1535,33044440,Caffeine Exacerbates Hyperventilation and Reductions in Cerebral Blood Flow in Physically Fit Men Exercising in the Heat.,"INTRODUCTION Caffeine is an exercise performance enhancer widely used by individuals engaged in training or competition under heat-stressed conditions. Caffeine ingestion during exercise in the heat is believed to be safe because it does not greatly affect body temperature responses, heart rate, or body fluid status. However, it remains unknown whether caffeine affects hyperthermia-induced hyperventilation or reductions in the cerebral blood flow index. We tested the hypothesis that under conditions inducing severe hyperthermia, caffeine exacerbates hyperthermia-induced hyperventilation and reduces the cerebral blood flow index during exercise. METHODS Using a randomized, single-blind, crossover design, 12 physically active healthy young men (23 ± 2 yr) consumed a moderate dose of caffeine (5 mg·kg-1) or placebo in the heat (37°C). Approximately 60 min after the ingestion, they cycled for ~45 min at a workload equal to ~55% of their predetermined peak oxygen uptake (moderate intensity) until their core temperature increased to 2.0°C above its preexercise baseline level. RESULTS In both trials, ventilation increased and the cerebral blood flow index assessed by middle cerebral artery mean blood velocity decreased as core temperature rose during exercise (P < 0.05), indicating that hyperthermia-induced hyperventilation and lowering of the cerebral blood flow occurred. When core temperature was elevated by 1.5°C or more (P < 0.05), ventilation was higher and the cerebral blood flow was lower throughout the caffeine trial than the placebo trial (P < 0.05). CONCLUSIONS A moderate dose of caffeine exacerbates hyperthermia-induced hyperventilation and reductions in the cerebral blood flow index during exercise in the heat with severe hyperthermia.",2021,"In both trials, ventilation increased and the cerebral blood flow index assessed by middle cerebral artery mean blood velocity decreased as core temperature rose during exercise (P<0.05), indicating that hyperthermia-induced hyperventilation and lowering of the cerebral blood flow index occurred.","['Physically Fit Males', 'twelve physically active healthy young males (23±2 years']","['placebo', 'caffeine', 'Caffeine', 'Caffeine ingestion']","['cerebral blood flow index', 'cerebral blood flow index assessed by middle cerebral artery mean blood velocity', 'Cerebral Blood Flow', 'body temperature responses, heart rate or body fluid status']","[{'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1531610', 'cui_str': 'Blood velocity'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",12.0,0.0395421,"In both trials, ventilation increased and the cerebral blood flow index assessed by middle cerebral artery mean blood velocity decreased as core temperature rose during exercise (P<0.05), indicating that hyperthermia-induced hyperventilation and lowering of the cerebral blood flow index occurred.","[{'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Fujii', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba, JAPAN.'}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Fujimoto', 'Affiliation': ''}, {'ForeName': 'Cao', 'Initials': 'C', 'LastName': 'Yinhang', 'Affiliation': ''}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Dobashi', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba, JAPAN.'}, {'ForeName': 'Ryoko', 'Initials': 'R', 'LastName': 'Matsutake', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba, JAPAN.'}, {'ForeName': 'Tatsuro', 'Initials': 'T', 'LastName': 'Amano', 'Affiliation': 'Laboratory for Exercise and Environmental Physiology, Faculty of Education, Niigata University, Niigata, JAPAN.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba, JAPAN.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Nishiyasu', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba, JAPAN.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002537'] 1536,33044441,A Single Bout of Premeal Resistance Exercise Improves Postprandial Glucose Metabolism in Obese Men with Prediabetes.,"INTRODUCTION Prediabetes is a major risk factor for type 2 diabetes and cardiovascular diseases. Although resistance exercise (RE) is recommended for individuals with prediabetes, the effects of RE on postprandial glucose metabolism in this population are poorly understood. Therefore, the purpose of this study was to elucidate how RE affects postprandial glucose kinetics, insulin sensitivity, beta cell function, and glucose oxidation during the subsequent meal in sedentary men with obesity and prediabetes. METHODS We studied 10 sedentary men with obesity (body mass index, 33 ± 3 kg·m-2) and prediabetes by using a randomized, cross-over study design. After an overnight fast, participants completed either a single bout of whole-body RE (seven exercises, 3 sets of 10-12 repetitions at 80% one-repetition maximum each) or an equivalent period of rest. Participants subsequently completed a mixed meal test in conjunction with an intravenous [6,6-2H2]glucose infusion to determine basal and postprandial glucose rate of appearance (Ra) and disappearance (Rd) from plasma, insulin sensitivity, and the insulinogenic index (a measure of beta cell function). Skeletal muscle biopsies were obtained 90 min postmeal to evaluate pyruvate-supported and maximal mitochondrial respiration. Whole-body carbohydrate oxidation was assessed using indirect calorimetry. RESULTS RE significantly reduced the postprandial rise in glucose Ra and plasma glucose concentration. Postprandial insulin sensitivity was significantly greater after RE, whereas postprandial plasma insulin concentration was significantly reduced. RE had no effect on the insulinogenic index, postprandial pyruvate respiration, or carbohydrate oxidation. CONCLUSION/INTERPRETATION A single bout of RE has beneficial effects on postprandial glucose metabolism in men with obesity and prediabetes by increasing postprandial insulin sensitivity, reducing the postprandial rise in glucose Ra, and reducing postprandial plasma insulin concentration.",2021,"RE had no effect on the insulinogenic index, postprandial pyruvate respiration, or carbohydrate oxidation.","['sedentary men with obesity and prediabetes', '10 sedentary men with obesity (BMI: 33 ± 3 kg/m) and prediabetes by using a randomized, cross-over study design', 'Obese Men with Prediabetes', 'individuals with prediabetes', 'men with obesity and pre-diabetes']","['Premeal Resistance Exercise', 'resistance exercise (RE']","['Postprandial Glucose Metabolism', 'insulinogenic index, postprandial pyruvate respiration, or carbohydrate oxidation', 'postprandial rise in glucose Ra and plasma glucose concentration', 'postprandial plasma insulin concentration', 'postprandial glucose kinetics, insulin sensitivity, beta cell function, and glucose oxidation', 'postprandial glucose rate of appearance (Ra) and disappearance (Rd) from plasma, insulin sensitivity, and the insulinogenic index (a measure of beta cell function', 'postprandial glucose metabolism', 'Postprandial insulin sensitivity']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034354', 'cui_str': 'Pyruvates'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0030281', 'cui_str': 'Structure of beta Cell of islet'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",10.0,0.0452448,"RE had no effect on the insulinogenic index, postprandial pyruvate respiration, or carbohydrate oxidation.","[{'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Bittel', 'Affiliation': 'Program in Physical Therapy, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Bittel', 'Affiliation': 'Program in Physical Therapy, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Mittendorfer', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Patterson', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Adewole L', 'Initials': 'AL', 'LastName': 'Okunade', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Nada A', 'Initials': 'NA', 'LastName': 'Abumrad', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Dominic N', 'Initials': 'DN', 'LastName': 'Reeds', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'William Todd', 'Initials': 'WT', 'LastName': 'Cade', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002538'] 1537,33063096,"Evaluation of the impact of a nurse-led program of patient self-assessment and self-management in axial spondyloarthritis: results of a prospective, multicentre, randomized, controlled trial (COMEDSPA).","OBJECTIVE To evaluate the impact of a nurse-led program of self-management and self-assessment of disease activity in axial spondyloarthritis. METHODS Prospective, randomized, controlled, open, 12-month trial (NCT02374749). Participants were consecutive axial spondyloarthritis patients (according to the rheumatologist) and nurses having participated in a 1-day training meeting. The program included self-management: educational video and specific video of graduated, home-based exercises for patients; and self-assessment: video presenting the rationale of tight monitoring of disease activity with composite scores (Ankylosing Spondylitis Disease activity Score, ASDAS/Bath Ankyslosing Spondylitis Disease Activity Index, BASDAI). The nurse trained patients to collect, calculate and report (monthly) ASDAS/BASDAI. Treatment allocation was by random allocation to this program or a comorbidities assessment (not presented here and considered here as the control group). RESULTS A total of 502 patients (250 and 252 in the active and control groups, respectively) were enrolled (age: 46.7 (12.2) years, male gender: 62.7%, disease duration: 13.7 (11.0) years). After the one-year follow-up period, the adherence to the self-assessment program was considered good (i.e. 79% reported scores >6 times). Despite a lack of statistical significance in the primary outcome (e.g. coping) there was a statistically significant difference in favor of this program for the following variables: change in BASDAI, number and duration of the home exercises in the active group, and physical activity (international physical activity score, IPAQ). CONCLUSION This study suggests a short-term benefit of a nurse-led program on self-management and self-assessment for disease activity in a young axial spondyloarthritis population in terms of disease activity, exercises and physical activity.",2021,"Despite a lack of statistical significance in the primary outcome (e.g. coping) there was a statistically significant difference in favor of this program for the following variables: change in BASDAI, number and duration of the home exercises in the active group, and physical activity (international physical activity score, IPAQ). ","['Participants were consecutive axial spondyloarthritis patients (according to the rheumatologist) and nurses having participated in a 1-day training meeting', 'axial spondyloarthritis', '502 patients (250 and 252 in the active and control groups, respectively) were enrolled (age: 46.7 (12.2)\u2009years, male gender: 62.7%, disease duration: 13.7 (11.0)\u2009years']","['nurse-led program', 'nurse-led program of patient self-assessment and self-management', 'self-management: educational video and specific video of graduated, home-based exercises for patients; and self-assessment: video presenting']","['physical activity (international physical activity score, IPAQ', 'BASDAI, number and duration of the home exercises', 'disease activity with composite scores (Ankylosing Spondylitis Disease activity Score, ASDAS/Bath Ankyslosing Spondylitis Disease Activity Index, BASDAI']","[{'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0334889', 'cui_str': 'Rheumatologist'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1998004', 'cui_str': 'Bath ankylosing spondylitis disease activity index'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0038012', 'cui_str': 'Spondylitis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",502.0,0.0285517,"Despite a lack of statistical significance in the primary outcome (e.g. coping) there was a statistically significant difference in favor of this program for the following variables: change in BASDAI, number and duration of the home exercises in the active group, and physical activity (international physical activity score, IPAQ). ","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Molto', 'Affiliation': 'Rheumatology Department, Cochin Hospital, Assistance Publique Hôpitaux de Paris, France.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Gossec', 'Affiliation': 'Sorbonne Université, IPLESP, INSERM, France.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Poiraudeau', 'Affiliation': 'Rehabilitation and Physical Medicine Department, Cochin Hospital, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Claudepierre', 'Affiliation': 'Rheumatology Department, Henri Mondor Hospital, Assistance Publique Hôpitaux de Paris, and Université Paris Est Créteil, EA, 7379 - EpidermE, Créteil, France.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Soubrier', 'Affiliation': 'Rheumatology Department, CHU Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Fayet', 'Affiliation': 'Rheumatology Department, CHU Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wendling', 'Affiliation': 'Rheumatology Department, CHRU de BESANCON, University Teaching Hospital, and Université Bourgogne Franche-Comté, EA4266 (EPILAB), Besançon, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gaudin', 'Affiliation': 'Rheumatology Department, CHU Grenoble, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Dernis', 'Affiliation': 'Rheumatology Department, CH Le Mans, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Guis', 'Affiliation': 'Rheumatology Department, CHU Marseille, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Pouplin', 'Affiliation': 'Rheumatology Department, CHU Rouen, France.'}, {'ForeName': 'Adeline', 'Initials': 'A', 'LastName': 'Ruyssen-Witrand', 'Affiliation': 'Centre de Rhumatologie, Hôpital Purpan, et Faculté de Médecine, Université Toulouse III, Paul Sabatier University, Inserm UMR1027, Toulouse, France.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Chales', 'Affiliation': 'Medecine Faculty, Department of Rheumatology, South Hospital, Rennes 1 University, Rennes, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Mariette', 'Affiliation': 'Rheumatology Department, APHP, Bicêtre Hospital, Le Kremlin-Bicetre, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Beauvais', 'Affiliation': 'Rheumatology Department, Saint Antoine Hospital, APHP, Paris, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Combe', 'Affiliation': 'Rheumatology Department, CHU Montpellier, Montpellier University, Montpellier, France.'}, {'ForeName': 'René-Marc', 'Initials': 'RM', 'LastName': 'Flipo', 'Affiliation': 'Rheumatology Department, CHU Roger Salengro Hospital, University of Lille, Lille, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Richette', 'Affiliation': 'Université Paris Diderot, UFR médicale, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Chary-Valckenaere', 'Affiliation': 'Department of Rheumatology, Nancy Hospital, Nancy, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Saraux', 'Affiliation': 'Rheumatology Unit, UMR1227 (Lymphocytes B et Autoimmunité), Université de Brest, Inserm, CHU, Brest, LabEx IGO, Brest, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Sibilia', 'Affiliation': 'Department of Rheumatology, Hautepierre CHU, Fédération de médecine translationnelle, UMR INSERM 1109, Strasbourg, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Schaeverbeke', 'Affiliation': 'Rheumatology Department, Pellegrin Hospital, Bordeaux, France.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Dougados', 'Affiliation': 'Rheumatology Department, Cochin Hospital, Assistance Publique Hôpitaux de Paris, France.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa480'] 1538,33063154,The Impact of Bariatric Surgery Compared to Medical Therapy on Health-Related Quality of Life in Subjects with Obesity and Type 2 Diabetes Mellitus.,"INTRODUCTION The adverse implications of obesity extend beyond physical health to include negative impact on quality of life (QoL), mood, and eating habits. While bariatric surgery provides successful weight loss and metabolic benefits, studies describe conflicting results on QoL and mood-related outcomes. METHODS Patients (n = 140) with class II/III obesity and T2DM were recruited from 2015 to 2019, and stratified based on medical or surgical treatment. Questionnaires including the Hospital Anxiety and Depression Scale, Euro QoL visual analogue scale (EQ-VAS), and Revised 21-item Three-Factor Eating Questionnaire (TFEQ-R21) were recorded at baseline, 6 months, and 12 months after treatment. RESULTS At baseline, the surgical group (n = 55) and medical group (n = 85) had no significant difference in questionnaire outcomes. At 6 and 12 months, EQ-VAS was higher in the surgical group (12 months surgical 82.00 ± 12.64, medical 72.81 ± 16.56, p = 0.001), with greater improvement from baseline. HADS-D scores at 12 months were lower in the surgical group (surgical 2.60 ± 2.88, medical 3.90 ± 3.58, p = 0.025). At 12 months, the surgical group also had better TFEQ-R21 scores, with higher cognitive restraint scores (surgical 19.09 ± 3.00, medical 16.69 ± 3.61, p < 0.001), and lower scores for uncontrolled eating (surgical 14.96 ± 3.87, medical 17.89 ± 5.34, p = 0.001). CONCLUSION In the treatment of patients with obesity and T2DM, bariatric surgery resulted in improved QoL outcomes at 12 months compared to medical therapy. This could be related to improvement in weight and metabolic outcomes, and altered gut-brain axis communication. This is the first prospective study assessing the impact of bariatric surgery on health-related QoL in Asia compared against a control group who received medical therapy.",2021,"HADS-D scores at 12 months were lower in the surgical group (surgical 2.60 ± 2.88, medical 3.90 ± 3.58, p = 0.025).","['Subjects with Obesity and Type 2 Diabetes Mellitus', 'patients with obesity and T2DM, bariatric surgery', 'Patients (n\u2009', '140) with class II/III obesity and T2DM were recruited from 2015 to 2019, and stratified based on medical or surgical treatment']","['bariatric surgery', 'medical therapy', 'Bariatric Surgery Compared to Medical Therapy']","['TFEQ-R21 scores', 'questionnaire outcomes', 'QoL outcomes', 'Hospital Anxiety and Depression Scale, Euro QoL visual analogue scale (EQ-VAS), and Revised 21-item Three-Factor Eating Questionnaire (TFEQ-R21', 'HADS-D scores', 'quality of life (QoL), mood, and eating habits', 'weight and metabolic outcomes', 'EQ-VAS', 'Health-Related Quality of Life', 'cognitive restraint scores']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C1533125', 'cui_str': 'Euro'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}]",,0.0289758,"HADS-D scores at 12 months were lower in the surgical group (surgical 2.60 ± 2.88, medical 3.90 ± 3.58, p = 0.025).","[{'ForeName': 'Sarah Ying Tse', 'Initials': 'SYT', 'LastName': 'Tan', 'Affiliation': 'Department of Endocrinology, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Kwang Wei', 'Initials': 'KW', 'LastName': 'Tham', 'Affiliation': 'Department of Endocrinology, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Ganguly', 'Affiliation': 'Department of Endocrinology, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Hong Chang', 'Initials': 'HC', 'LastName': 'Tan', 'Affiliation': 'Department of Endocrinology, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Xin', 'Affiliation': 'Health Services Research Unit, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Henry Yuen Foong', 'Initials': 'HYF', 'LastName': 'Lew', 'Affiliation': 'Department of Psychology, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Chin Hong', 'Initials': 'CH', 'LastName': 'Lim', 'Affiliation': 'Department of Upper Gastrointestinal and Bariatric Surgery, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Tan', 'Affiliation': 'Department of Upper Gastrointestinal and Bariatric Surgery, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Kay Yuan', 'Initials': 'KY', 'LastName': 'Chong', 'Affiliation': 'Division of Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Phong Ching', 'Initials': 'PC', 'LastName': 'Lee', 'Affiliation': 'Department of Endocrinology, Singapore General Hospital, Singapore, Singapore. Lee.phong.ching@singhealth.com.sg.'}]",Obesity surgery,['10.1007/s11695-020-05038-6'] 1539,33063157,Diminished Counterregulatory Responses to Meal-Induced Hypoglycemia 4 Years After RYGB.,"PURPOSE Post-bariatric hypoglycemia is a complication of bariatric surgery, especially Roux-en-Y gastric bypass (RYGB). The counterregulatory hormonal and sympathetic neural responses were measured during a previously reported meal test in which 48% had an almost asymptomatic hypoglycemic event. MATERIALS AND METHODS Forty-four randomly selected patients 4 years after RYGB. A liquid meal test (MMT) after overnight fasting. Based on the glucose nadir during the MMT, patients were divided in a hypo group (glucose < 3.3 mmol/L) and a non-hypo group (glucose ≥ 3.3 mmol/L). Cortisol, epinephrine, norepinephrine, blood pressure, and heart rate were measured up to 180 min after ingestion of the meal. Incremental areas under the curve (iAUC), peak, and delta hormone responses after the glucose nadir were calculated. Parameters were compared between the hypo and non-hypo groups. RESULTS A total of 21/44 (48%) had an almost asymptomatic hypoglycemic event. Cortisol and epinephrine responses in the hypo group were not increased compared to the non-hypo group, and there were no signs of increased sympathetic nerve activity. Peak and delta cortisol were lower in the hypo compared to the non-hypo group. Norepinephrine was higher in the hypo group especially in the time frame 60-120 and 120-180 min after start of the meal. CONCLUSION No increase in epinephrine and a lower cortisol response to hypoglycemia were observed compared to normoglycemia during a meal test in patients after RYGB. Norepinephrine levels were higher in the hypo group. These findings may suggest that possible recurrent hypoglycemia after RYGB results in blunting of counterregulatory responses indicative of hypoglycemia-induced autonomic failure. CLIN TRIAL REGISTER ID ISRCTN 11738149.",2021,"Cortisol and epinephrine responses in the hypo group were not increased compared to the non-hypo group, and there were no signs of increased sympathetic nerve activity.",['Forty-four randomly selected patients 4\xa0years after RYGB'],"['epinephrine', 'Norepinephrine']","['sympathetic nerve activity', 'Cortisol, epinephrine, norepinephrine, blood pressure, and heart rate', 'Incremental areas under the curve (iAUC), peak, and delta hormone responses', 'counterregulatory hormonal and sympathetic neural responses', 'asymptomatic hypoglycemic event', 'Peak and delta cortisol', 'cortisol response to hypoglycemia', 'Norepinephrine levels', 'Counterregulatory Responses', 'Cortisol and epinephrine responses']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}]","[{'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",44.0,0.0168144,"Cortisol and epinephrine responses in the hypo group were not increased compared to the non-hypo group, and there were no signs of increased sympathetic nerve activity.","[{'ForeName': 'Loek J M', 'Initials': 'LJM', 'LastName': 'de Heide', 'Affiliation': 'Center for Obesity North-Netherlands (CON), Medical Center Leeuwarden, H. Dunantweg 2, 8934 AD, Leeuwarden, The Netherlands. l.de.heide@mcl.nl.'}, {'ForeName': 'Merel', 'Initials': 'M', 'LastName': 'van den Broek', 'Affiliation': 'Center for Obesity North-Netherlands (CON), Medical Center Leeuwarden, H. Dunantweg 2, 8934 AD, Leeuwarden, The Netherlands.'}, {'ForeName': 'Gertjan', 'Initials': 'G', 'LastName': 'van Dijk', 'Affiliation': 'GELIFES-Neurobiology, Department of Behavioral Neuroscience, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Marloes', 'Initials': 'M', 'LastName': 'Emous', 'Affiliation': 'Center for Obesity North-Netherlands (CON), Medical Center Leeuwarden, H. Dunantweg 2, 8934 AD, Leeuwarden, The Netherlands.'}, {'ForeName': 'André P', 'Initials': 'AP', 'LastName': 'van Beek', 'Affiliation': 'Department of Endocrinology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}]",Obesity surgery,['10.1007/s11695-020-05035-9'] 1540,33055188,The Mineralocorticoid Receptor Antagonist Eplerenone Suppresses Interstitial Fibrosis in Subcutaneous Adipose Tissue in Patients With Type 2 Diabetes.,"Activation of the mineralocorticoid receptor (MR) may promote dysfunctional adipose tissue in patients with type 2 diabetes, where increased pericellular fibrosis has emerged as a major contributor. The knowledge of the association among the MR, fibrosis, and the effects of an MR antagonist (MRA) in human adipocytes remains very limited. The present substudy, including 30 participants, was prespecified as part of the Mineralocorticoid Receptor Antagonist in Type 2 Diabetes (MIRAD) trial, which randomized patients to either high-dose eplerenone or placebo for 26 weeks. In adipose tissue biopsies, changes in fibrosis were evaluated by immunohistological examination and by the expression of mRNA and protein markers of fibrosis. Treatment with an MRA reduced pericellular fibrosis, synthesis of the major subunits of collagen types I and VI, and the profibrotic factor α-smooth muscle actin compared with placebo in subcutaneous adipose tissue. Furthermore, we found decreased expression of the MR and downstream molecules neutrophil gelatinase-associated lipocalin, galectin-3, and lipocalin-like prostaglandin D2 synthase with an MRA. In conclusion, we present original data demonstrating reduced fibrosis in adipose tissue with inhibition of the MR, which could be a potential therapeutic approach to prevent the extracellular matrix remodeling of adipose tissue in type 2 diabetes.",2021,"Furthermore, we found decreased expression of the MR and downstream molecules neutrophil gelatinase-associated lipocalin, galectin-3, and lipocalin-like prostaglandin D2 synthase with an MRA.","['30 participants was prespecified as part of the Mineralocorticoid Receptor Antagonist in type 2 Diabetes (MIRAD) trial, randomizing patients to either high dose', 'Type 2 Diabetes Patients', 'patients with type 2 diabetes']","['MRA', 'Mineralocorticoid Receptor Antagonist Eplerenone', 'placebo', 'MR antagonist (MRA', 'eplerenone or placebo', 'mineralocorticoid receptor (MR']","['expression of the MR and downstream molecules neutrophil gelatinase-associated lipocalin, galectin-3, and lipocalin-like prostaglandin D2 synthase with an MRA']","[{'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0961485', 'cui_str': 'eplerenone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0066563', 'cui_str': 'Mineralocorticoid Receptor'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0066563', 'cui_str': 'Mineralocorticoid Receptor'}, {'cui': 'C0522506', 'cui_str': 'Downstream'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0206528', 'cui_str': 'Gelatinase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1956074', 'cui_str': 'Lipocalin'}, {'cui': 'C0245382', 'cui_str': 'Galectin-3'}, {'cui': 'C0072296', 'cui_str': 'Prostaglandin-H>2< D-isomerase'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}]",30.0,0.0233468,"Furthermore, we found decreased expression of the MR and downstream molecules neutrophil gelatinase-associated lipocalin, galectin-3, and lipocalin-like prostaglandin D2 synthase with an MRA.","[{'ForeName': 'Marie Louise', 'Initials': 'ML', 'LastName': 'Johansen', 'Affiliation': 'Centre of Endocrinology and Metabolism, Department of Internal Medicine, Copenhagen University Hospital, Herlev/Gentofte Hospital, Herlev, Denmark.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Ibarrola', 'Affiliation': 'Cardiovascular Translational Research, Navarrabiomed, Complejo Hospitalario de Navarra (CHN), Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Amaya', 'Initials': 'A', 'LastName': 'Fernández-Celis', 'Affiliation': 'Cardiovascular Translational Research, Navarrabiomed, Complejo Hospitalario de Navarra (CHN), Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Schou', 'Affiliation': 'Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mette Pauli', 'Initials': 'MP', 'LastName': 'Sonne', 'Affiliation': 'Centre of Endocrinology and Metabolism, Department of Internal Medicine, Copenhagen University Hospital, Herlev/Gentofte Hospital, Herlev, Denmark.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Refsgaard Holm', 'Affiliation': 'Department of Endocrinology, Rigshospitalet, Copenhagen University Hospital, Denmark.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Endocrinology, Rigshospitalet, Copenhagen University Hospital, Denmark.'}, {'ForeName': 'Flemming', 'Initials': 'F', 'LastName': 'Dela', 'Affiliation': 'Center for Healthy Aging, Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Jaisser', 'Affiliation': 'INSERM UMRS 1138, Centre de Recherche des Cordeliers, Sorbonne University, Paris, France.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Faber', 'Affiliation': 'Centre of Endocrinology and Metabolism, Department of Internal Medicine, Copenhagen University Hospital, Herlev/Gentofte Hospital, Herlev, Denmark.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': 'Université de Lorraine, INSERM CIC Plurithémathique 1433, INSERM UMRS 1116, CHRU Vandoeuvre-les-Nancy, and FCRIN INI-CRCT, Nancy, France.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Lopez-Andres', 'Affiliation': 'Cardiovascular Translational Research, Navarrabiomed, Complejo Hospitalario de Navarra (CHN), Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Kistorp', 'Affiliation': 'Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark cnkistorp@dadlnet.dk.'}]",Diabetes,['10.2337/db20-0394'] 1541,33057807,Romosozumab followed by denosumab in Japanese women with high fracture risk in the FRAME trial.,"INTRODUCTION This post-hoc analysis of the FRAME study investigated the long-term efficacy and safety of romosozumab followed by denosumab in postmenopausal Japanese women with osteoporosis at high fracture risk. MATERIALS AND METHODS Data from Japanese women with a high fracture risk participating in the international, randomised, double-blind, placebo-controlled, phase 3 FRAME study were analysed. High risk of fracture was defined as ≥ 1 fragility fracture with bone mineral density (BMD) ≤ - 2.5 standard deviations [SD], > 2 prevalent vertebral fractures, prevalent semiquantitative grade 3 vertebral fracture, or lumbar spine BMD < - 3.3 SD. Endpoints included incidence of new vertebral fracture at 12, 24 and 36 months and percentage change from baseline in BMD at the lumbar spine, total hip and femoral neck. RESULTS 187 Japanese subjects at high risk of fracture were enrolled in FRAME. Incidence of new vertebral fractures was lower with romosozumab/denosumab vs. placebo/denosumab at 12, 24 and 36 months (relative risk reduction at all timepoints: 84%; p = 0.056). BMD increases at 12, 24 and 36 months were greater in subjects receiving romosozumab/denosumab than placebo/denosumab (lumbar spine: 16.3%, 21.5% and 23.2% vs 0.4%, 8.1% and 10.4%; total hip: 4.9%, 7.9% and 8.9% vs 0.4%, 2.8% and 4.1%; femoral neck: 4.8%, 7.6% and 8.1% vs 0.3%, 3.3% and 3.7%, respectively; all p < 0.001 vs placebo/denosumab). Adverse events were generally balanced between groups. CONCLUSION Romosozumab/denosumab in Japanese subjects at high risk of fracture resulted in significant BMD gains and numerically lower vertebral fracture rate vs. placebo/denosumab at all timepoints measured.",2021,"BMD increases at 12, 24 and 36 months were greater in subjects receiving romosozumab/denosumab than placebo/denosumab (lumbar spine: 16.3%, 21.5% and 23.2% vs 0.4%, 8.1% and 10.4%; total hip: 4.9%, 7.9% and 8.9% vs 0.4%, 2.8% and 4.1%; femoral neck: 4.8%, 7.6% and 8.1% vs 0.3%, 3.3% and 3.7%, respectively; all p < 0.001 vs placebo/denosumab).","['1 fragility fracture with bone mineral density (BMD)\u2009≤\u2009-\u20092.5 standard deviations [SD],\u2009>\u20092 prevalent vertebral fractures, prevalent semiquantitative grade 3 vertebral fracture, or lumbar spine BMD', 'Japanese subjects', '187 Japanese subjects at high risk of fracture were enrolled in FRAME', 'Data from Japanese women with a high fracture risk participating in the international', 'Japanese women with high fracture risk in the FRAME trial', 'postmenopausal Japanese women with osteoporosis at high fracture risk']","['Romosozumab followed by denosumab', 'romosozumab', 'romosozumab/denosumab vs. placebo/denosumab', 'placebo/denosumab', 'placebo', 'Romosozumab/denosumab', 'denosumab']","['BMD at the lumbar spine, total hip and femoral neck', 'BMD gains', 'Adverse events', 'vertebral fracture rate', 'Incidence of new vertebral fractures', 'incidence of new vertebral fracture', 'BMD']","[{'cui': 'C4760971', 'cui_str': 'Fragility fracture'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}]","[{'cui': 'C3661283', 'cui_str': 'romosozumab'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205314', 'cui_str': 'New'}]",187.0,0.185119,"BMD increases at 12, 24 and 36 months were greater in subjects receiving romosozumab/denosumab than placebo/denosumab (lumbar spine: 16.3%, 21.5% and 23.2% vs 0.4%, 8.1% and 10.4%; total hip: 4.9%, 7.9% and 8.9% vs 0.4%, 2.8% and 4.1%; femoral neck: 4.8%, 7.6% and 8.1% vs 0.3%, 3.3% and 3.7%, respectively; all p < 0.001 vs placebo/denosumab).","[{'ForeName': 'Akimitsu', 'Initials': 'A', 'LastName': 'Miyauchi', 'Affiliation': 'Miyauchi Medical Center, Osaka, Japan.'}, {'ForeName': 'Etsuro', 'Initials': 'E', 'LastName': 'Hamaya', 'Affiliation': 'Amgen K.K., Midtown Tower 9-7-1 Akasaka Minato-ku, Tokyo, 107-6239, Japan. ehamaya@amgen.com.'}, {'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Nishi', 'Affiliation': 'Amgen K.K., Midtown Tower 9-7-1 Akasaka Minato-ku, Tokyo, 107-6239, Japan.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Libanati', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Cae', 'Initials': 'C', 'LastName': 'Tolman', 'Affiliation': 'Amgen Asia, Hong Kong, SAR, China.'}, {'ForeName': 'Junichiro', 'Initials': 'J', 'LastName': 'Shimauchi', 'Affiliation': 'Amgen K.K., Midtown Tower 9-7-1 Akasaka Minato-ku, Tokyo, 107-6239, Japan.'}]",Journal of bone and mineral metabolism,['10.1007/s00774-020-01147-5'] 1542,33059959,"HIV Care Cascade Among Adolescents in a ""Test and Treat"" Community-Based Intervention: HPTN 071 (PopART) for Youth Study.","PURPOSE The PopART for Youth (P-ART-Y) study was nested within the HPTN 071 (PopART) trial, a three-arm community randomized trial in 21 communities in Zambia and South Africa. The P-ART-Y study evaluated the acceptability and uptake of a combination HIV prevention package among young people. We report on the HIV care cascade for adolescents aged 10-19 years from 14 communities receiving the full HIV prevention package in Zambia and South Africa. METHODS Adolescents were offered participation in the PopART intervention, which included universal home-based HIV testing, linkage to care, antiretroviral therapy (ART) adherence, and other services. Data were collected from September 2016 to December 2017, covering the third round (R3) of the intervention. RESULTS We enumerated (listed) 128,241 adolescents (Zambia: 95,295 and South Africa: 32,946). Of the adolescents offered HIV testing, 81.9% accepted in Zambia and 70.3% in South Africa. Knowledge of HIV status was higher among older adolescents and increased from 31.4% before R3 to 88.3% at the end of R3 in Zambia and from 28.3% to 79.5% in South Africa. Overall, there were 1,710 (1.9%) adolescents identified as living with HIV by the end of R3 (515 new diagnoses and 1,195 self-reported). Of the new diagnoses, 335 (65.0%) were girls aged 15-19 years. The median time to initiate ART was 5 months. ART coverage before and after R3 increased from 61.3% to 78.7% in Zambia and from 65.6% to 87.8% in South Africa, with boys having higher uptake than girls in both countries. CONCLUSIONS The PopART intervention substantially increased coverage toward the first and second UNAIDS 90-90-90 targets in adolescents.",2021,Knowledge of HIV status was higher among older adolescents and increased from 31.4% before R3 to 88.3% at the end of R3 in Zambia and from 28.3% to 79.5% in South Africa.,"['young people', 'Adolescents', 'Youth (P-ART-Y) study was nested within the HPTN 071 (PopART) trial, a three-arm community randomized trial in 21 communities in Zambia and South Africa', '128,241 adolescents (Zambia: 95,295 and South Africa: 32,946', 'adolescents aged 10-19 years from 14 communities receiving the full HIV prevention package in Zambia and South Africa', 'Of the new diagnoses, 335 (65.0%) were girls aged 15-19 years']","['PopART intervention, which included universal home-based HIV testing, linkage to care, antiretroviral therapy (ART) adherence, and other services', 'combination HIV prevention package', 'PopART intervention']","['ART coverage', 'median time to initiate ART', 'Knowledge of HIV status', 'HIV Care Cascade']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C2585997', 'cui_str': 'New diagnosis'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",128241.0,0.0512208,Knowledge of HIV status was higher among older adolescents and increased from 31.4% before R3 to 88.3% at the end of R3 in Zambia and from 28.3% to 79.5% in South Africa.,"[{'ForeName': 'Kwame', 'Initials': 'K', 'LastName': 'Shanaube', 'Affiliation': 'Zambart, Lusaka, Zambia. Electronic address: kshanaube@zambart.org.zm.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Macleod', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Mwate Joseph', 'Initials': 'MJ', 'LastName': 'Chaila', 'Affiliation': 'Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Mackworth-Young', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Hoddinott', 'Affiliation': 'Desmond Tutu TB Centre, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Ab', 'Initials': 'A', 'LastName': 'Schaap', 'Affiliation': 'Zambart, Lusaka, Zambia; Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Floyd', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bock', 'Affiliation': 'Desmond Tutu TB Centre, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hayes', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Fidler', 'Affiliation': 'Faculty of Medicine, Department of Infectious Disease, Imperial College, London, United Kingdom.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Ayles', 'Affiliation': 'Zambart, Lusaka, Zambia; Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2020.07.029'] 1543,33057976,Effects of a Home-Based Intervention on HIV Prevention Health Behaviors in Pregnant/Postpartum Kenyan Women: Estimating Moderating Effects of Depressive Symptoms.,"We estimated effects of maternal depressive symptoms, utilizing the Patient Health Questionnaire-8 (PHQ-8), on women's HIV prevention behaviors in Migori County, Kenya. Pregnant women ≥ 18 years old, with gestational age of < 37 weeks, were randomized into standard care or three home visits (2 during pregnancy, 1 postpartum) promoting couple HIV testing and counseling (CHTC) and HIV prevention. Of 105 female participants, 37 (35.24%) reported depressive symptoms and 50 (47.62%) were HIV-positive. Three Poisson regressions with robust variance (univariable, multivariable, and multivariable with depressive symptoms/study arm interaction) were modeled for three outcomes: CHTC, infant HIV testing, health-seeking postpartum. In multivariable analysis with interaction, a moderating trend for the interaction between depressive symptoms and individual health-seeking was observed (p-value = 0.067). Women scoring ≤ 9 (n = 68) on the PHQ-8 and participating in home visits were 1.76 times more likely to participate in individual health-seeking compared to participants in standard care (ARR 1.76, 95% CI 1.17-2.66).",2021,"In multivariable analysis with interaction, a moderating trend for the interaction between depressive symptoms and individual health-seeking was observed (p-value = 0.067).","['Pregnant/Postpartum Kenyan Women', 'Pregnant women\u2009≥\u200918\xa0years old, with gestational age of\u2009<\u200937\xa0weeks', ""women's HIV prevention behaviors in Migori County, Kenya"", '105 female participants, 37 (35.24%) reported depressive symptoms and 50 (47.62%) were HIV-positive']","['Home-Based Intervention', 'standard care or three home visits (2 during pregnancy, 1 postpartum) promoting couple HIV testing and counseling (CHTC) and HIV prevention']","['depressive symptoms and individual health-seeking', 'individual health-seeking', 'HIV Prevention Health Behaviors']","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0337839', 'cui_str': 'Kenyans'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",105.0,0.0745201,"In multivariable analysis with interaction, a moderating trend for the interaction between depressive symptoms and individual health-seeking was observed (p-value = 0.067).","[{'ForeName': 'Jami L', 'Initials': 'JL', 'LastName': 'Anderson', 'Affiliation': 'Department of Health Services Administration, School of Health Professions, University of Alabama at Birmingham, SHPB 553, 1716 9th Ave South, Birmingham, AL, 35294, USA. jamianderson@uab.edu.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Bukusi', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Lynae A', 'Initials': 'LA', 'LastName': 'Darbes', 'Affiliation': 'Center for Sexuality and Health Disparities, Department of Health Behavior and Biological Sciences, School of Nursing, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Abigail M', 'Initials': 'AM', 'LastName': 'Hatcher', 'Affiliation': 'School of Public Health, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Helova', 'Affiliation': 'Department of Health Care Organization and Policy, School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Zachary A', 'Initials': 'ZA', 'LastName': 'Kwena', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Pamela L', 'Initials': 'PL', 'LastName': 'Musoke', 'Affiliation': 'Center for Social and Behavioral Research, University of Northern Iowa, Cedar Falls, IA, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Owino', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Oyaro', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Anna Joy G', 'Initials': 'AJG', 'LastName': 'Rogers', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Tennessee Health Science Center, Memphis, TN, USA.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Turan', 'Affiliation': 'Department of Health Care Organization and Policy, School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA.'}]",AIDS and behavior,['10.1007/s10461-020-03046-2'] 1544,33034015,Outcomes with Intra-gastric Balloon Therapy in BMI < 35 Non-morbid Obesity: 10-Year Follow-Up Study of an RCT.,"PURPOSE Intra-gastric balloon (IGB) therapy is the most established endoscopic treatment of obesity, but there is a paucity of literature on long-term efficacy. This study aims to evaluate the short- and long-term weight loss efficacy of IGB. MATERIALS AND METHODS Double-blinded RCT with 6-month IGB vs with sham endoscopy, in body mass index (BMI) 27-35 patients. Anthropometric, fasting glucose, and lipid profile measurement as early outcomes (up to 2 years) and 10-year follow-up. Primary outcomes were total body weight loss (kg) and BMI. Secondary outcomes were new-onset diabetes mellitus, other new comorbidities, and willingness for further intervention. RESULTS Initial RCT recruited 99 patients (50 IGB vs 49 sibutramine group). Forty-nine patients (26 IGB vs 23 control group) participated in a 10-year review (follow-up rate of 51.6%). Total body weight loss at 6 (9.75 vs 7.48 kg, p = 0.03), 12 (6.52 vs 4.42 kg, p = 0.05), 18 (5.42 vs 3.57, p = 0.32), and 24 months (4.07 vs 2.93 kg, p = 0.56) favored the IGB group. Total weight loss (TWL) at 10 years (0.03 vs - 2.32 kg, p = 0.05) and %TWL (- 0.16 ± 12.8% vs - 2.84 ± 5.6%, p = 0.39) were not significantly different between groups. Follow-up BMI (30.97 ± 1.6 vs 30.38 ± 1.8 kg/m 2 , p = 1.00) was similar. At 10 years, new-onset diabetes mellitus, sleep apnoea, metabolic syndrome, and arthralgia were not significant (p > 0.05). Twenty-three (81%) IGB group vs 13 (56%) control expressed a willingness for further intervention (p < 0.01). CONCLUSION IGB delivers weight loss to 2 years and is superior to control. However, new comorbidity development is not significantly different at 10 years. Patient that received IGB therapy were subsequently more willing for further bariatric metabolic intervention.",2021,"IGB group vs 13 (56%) control expressed a willingness for further intervention (p < 0.01). ","['Forty-nine patients (26 IGB vs 23 control group) participated in a 10-year review (follow-up rate of 51.6', 'BMI <\u200935 Non-morbid Obesity']","['IGB therapy', 'IGB', 'Intra-gastric Balloon Therapy', 'gastric balloon (IGB) therapy']","['Total weight loss (TWL', 'new-onset diabetes mellitus, sleep apnoea, metabolic syndrome, and arthralgia', 'total body weight loss (kg) and BMI', 'new-onset diabetes mellitus, other new comorbidities, and willingness for further intervention', 'Anthropometric, fasting glucose, and lipid profile measurement', 'Total body weight loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0017124', 'cui_str': 'Gastric balloon'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0017124', 'cui_str': 'Gastric balloon'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",99.0,0.054543,"IGB group vs 13 (56%) control expressed a willingness for further intervention (p < 0.01). ","[{'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Chan', 'Affiliation': 'Division of Upper Gastrointestinal & Metabolic Surgery, Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Josil R', 'Initials': 'JR', 'LastName': 'Cruz', 'Affiliation': 'Department of Surgery, Southern Philippines Medical Center, Davao City, Philippines.'}, {'ForeName': 'Wilfred L', 'Initials': 'WL', 'LastName': 'Mui', 'Affiliation': 'Hong Kong Bariatric and Metabolic Institute, Hong Kong, Hong Kong.'}, {'ForeName': 'Simon K H', 'Initials': 'SKH', 'LastName': 'Wong', 'Affiliation': 'Division of Upper Gastrointestinal & Metabolic Surgery, Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Enders K W', 'Initials': 'EKW', 'LastName': 'Ng', 'Affiliation': 'Division of Upper Gastrointestinal & Metabolic Surgery, Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, Hong Kong. endersng@surgery.cuhk.edu.hk.'}]",Obesity surgery,['10.1007/s11695-020-04986-3'] 1545,33031566,"Maternal body mass index and risk of obstetric, maternal and neonatal outcomes: A cohort study of nulliparous women with spontaneous onset of labor.","INTRODUCTION This study investigates associations between maternal body mass index (BMI) early in pregnancy and obstetric interventions, maternal and neonatal outcomes. MATERIAL AND METHODS This is a cohort study of nulliparous women originally included in a cluster randomized controlled trial carried out at 14 Norwegian obstetric units between 2014 and 2017. The sample included 7189 nulliparous women with a singleton fetus, cephalic presentation and spontaneous onset of labor at term, denoted as group 1 in the Ten-Group Classification System. The women were grouped according to the World Health Organization BMI classifications: underweight (BMI <18.5), normal weight (BMI 18.5-24.9), pre-obesity (BMI 25.0-29.9), obesity class I (BMI 30.0-34.9), and obesity classes II and III (BMI ≥35.0). We used binary logistic regression to estimate crude and adjusted odds ratios (ORs) of the interventions and outcomes, with associated 95% confidence intervals (CIs), comparing women in different BMI groups with women of normal weight. RESULTS We found an increased risk of intrapartum cesarean section in women of obesity class I and obesity classes II and III, with adjusted OR of 1.70 (95% CI 1.21-2.38) and 2.31 (95% CI 1.41-3.77), respectively. Women in obesity groups had a gradient of risk of epidural analgesia and use of continuous CTG (including STAN), with adjusted OR of 2.39 (95% CI 1.69-3.38) and 3.28 (95% CI 1.97-5.48), respectively. Women in obesity classes II and III had higher risk of amniotomy (adjusted OR = 1.42, 95% CI 1.02-1.96), oxytocin augmentation (adjusted OR = 1.54, 95% CI 1.11-2.15), obstetric anal sphincter injuries (adjusted OR = 2.21, 95% CI 1.01-4.85) and postpartum hemorrhage ≥1000 mL (adjusted OR = 2.20, 95% CI 1.29-3.78). We found a reduced likelihood of spontaneous vaginal delivery for pre-obese women (adjusted OR = 0.85, 95% CI 0.74-0.97) and no associations between maternal BMI and neonatal outcomes. CONCLUSIONS Obese women in Ten-Group Classification System group 1 had increased risks of obstetric interventions and maternal complications. There was a gradient of risk for intrapartum cesarean section, with the highest risk for women in obesity classes II and III. No associations between maternal BMI and neonatal outcomes were observed.",2021,We found a reduced likelihood of spontaneous vaginal delivery for pre-obese women (adjusted OR = 0.85,"['pre-obese women (adjusted OR = 0.85', 'nulliparous women originally included in a cluster randomized controlled trial carried out at 14 Norwegian obstetric units between 2014 and 2017', ""women were grouped according to the World Health Organization's BMI classifications: underweight (BMI < 18.5), normal weight (BMI 18.5-24.9), pre-obesity (BMI 25.0-29.9), obesity class"", '7189 nulliparous women with a singleton fetus, cephalic presentation and spontaneous onset of labor at term, denoted as group 1 in the Ten-Group Classification System', 'women of obesity class', 'nulliparous women with spontaneous onset of labor']",[],"['Maternal body mass index and risk of obstetric, maternal, and neonatal outcomes', 'obesity classes II and III', 'maternal BMI and neonatal outcomes', 'risk of intrapartum cesarean section', 'risk of amniotomy', 'oxytocin augmentation', 'obstetric anal sphincter injuries', 'spontaneous vaginal delivery', 'risks of obstetric interventions and maternal complications', 'risk of epidural analgesia', 'maternal body mass index (BMI']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C4517483', 'cui_str': '0.85'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C4517611', 'cui_str': '18.5'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0205096', 'cui_str': 'Cephalic'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0474461', 'cui_str': 'Spontaneous onset of labor'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}]",[],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C1384591', 'cui_str': 'Artificial rupture of membranes'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C1142258', 'cui_str': 'Anal sphincter injury'}, {'cui': 'C0269694', 'cui_str': 'Normal delivery procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}]",7189.0,0.163517,We found a reduced likelihood of spontaneous vaginal delivery for pre-obese women (adjusted OR = 0.85,"[{'ForeName': 'Rebecka', 'Initials': 'R', 'LastName': 'Dalbye', 'Affiliation': 'Department of Obstetrics and Gynecology, Østfold Hospital Trust, Grålum, Norway.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Gunnes', 'Affiliation': ""Norwegian National Advisory Unit on Women's Health, Oslo University Hospital, Oslo, Norway.""}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Blix', 'Affiliation': 'Department of Nursing and Health Promotion, Faculty of Health Sciences, OsloMet - Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Xinhua Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Torbjørn', 'Initials': 'T', 'LastName': 'Eggebø', 'Affiliation': ""National Center for Fetal Medicine, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway.""}, {'ForeName': 'Linn', 'Initials': 'L', 'LastName': 'Nistov Tokheim', 'Affiliation': 'Department of Obstetrics and Gynecology, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Pål', 'Initials': 'P', 'LastName': 'Øian', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital of North Norway, Norway, Tromsø, Norway.'}, {'ForeName': 'Stine', 'Initials': 'S', 'LastName': 'Bernitz', 'Affiliation': 'Department of Obstetrics and Gynecology, Østfold Hospital Trust, Grålum, Norway.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.14017'] 1546,33036995,Does load management using the acute:chronic workload ratio prevent health problems? A cluster randomised trial of 482 elite youth footballers of both sexes.,"BACKGROUND The acute:chronic workload ratio (ACWR) is commonly used to manage training load in sports, particularly to reduce injury risk. However, despite its extensive application as a prevention intervention, the effectiveness of load management using ACWR has never been evaluated in an experimental study. AIM To evaluate the effectiveness of a load management intervention designed to reduce the prevalence of health problems among elite youth football players of both sexes. METHODS We cluster-randomised 34 elite youth football teams (16 females, 18 males) to an intervention group (18 teams) and a control group (16 teams). Intervention group coaches planned all training based on published ACWR load management principles using a commercially available athlete management system for a complete 10-month season. Control group coaches continued to plan training as normal. The prevalence of health problems was measured monthly in both groups using the Oslo Sports Trauma Research Centre Questionnaire on Health Problems. RESULTS The between-group difference in health problem prevalence (primary outcome) was 1.8%-points (-4.1 to 7.7 %-points; p=0.55) with no reduction in the likelihood of reporting a health problem in the intervention group (relative risk 1.01 (95% CI 0.91 to 1.12); p=0.84) compared with the control group. CONCLUSIONS We observed no between-group difference, suggesting that this specific load management intervention was not successful in preventing health problems in elite youth footballers. TRIAL REGISTRATION NUMBER ISRCTN18177140.",2021,"The prevalence of health problems was measured monthly in both groups using the Oslo Sports Trauma Research Centre Questionnaire on Health Problems. ","['elite youth football players of both sexes', '34 elite youth football teams (16 females, 18 males) to an intervention group (18 teams) and a control group (16 teams', '482 elite youth footballers of both sexes']","['load management intervention', 'Intervention group coaches planned all training based on published ACWR load management principles using a commercially available athlete management system']","['prevalence of health problems', 'health problem prevalence', 'likelihood of reporting a health problem', 'health problems']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034037', 'cui_str': 'Publishing'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",,0.0814471,"The prevalence of health problems was measured monthly in both groups using the Oslo Sports Trauma Research Centre Questionnaire on Health Problems. ","[{'ForeName': 'Torstein', 'Initials': 'T', 'LastName': 'Dalen-Lorentsen', 'Affiliation': 'Oslo Sports Trauma Research Center, Department of Sports Medicine, Norwegian School of Sports Sciences, Oslo, Norway torstein.dalen@nih.no.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bjørneboe', 'Affiliation': 'Oslo Sports Trauma Research Center, Department of Sports Medicine, Norwegian School of Sports Sciences, Oslo, Norway.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Clarsen', 'Affiliation': 'Oslo Sports Trauma Research Center, Department of Sports Medicine, Norwegian School of Sports Sciences, Oslo, Norway.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Vagle', 'Affiliation': 'Oslo Sports Trauma Research Center, Department of Sports Medicine, Norwegian School of Sports Sciences, Oslo, Norway.'}, {'ForeName': 'Morten Wang', 'Initials': 'MW', 'LastName': 'Fagerland', 'Affiliation': 'Oslo Sports Trauma Research Center, Department of Sports Medicine, Norwegian School of Sports Sciences, Oslo, Norway.'}, {'ForeName': 'Thor Einar', 'Initials': 'TE', 'LastName': 'Andersen', 'Affiliation': 'Oslo Sports Trauma Research Center, Department of Sports Medicine, Norwegian School of Sports Sciences, Oslo, Norway.'}]",British journal of sports medicine,['10.1136/bjsports-2020-103003'] 1547,33035140,Does Baseline Serum Testosterone Influence Androgen Deprivation Therapy Outcomes in Hormone Naïve Patients with Advanced Prostate Cancer?,"PURPOSE To study baseline serum testosterone's prognostic value in hormone naïve advanced prostate cancer patients receiving continuous androgen deprivation therapy. MATERIALS AND METHODS The study population undergoing continuous androgen deprivation therapy (agonist or antagonist) with 1-year followup was pooled for post-hoc analysis from 2 large prospective, randomized, parallel arm phase 3b trials (NCT00295750-Global; NCT00928434-USA). Survival end points were evaluated for baseline serum testosterone effect as a continuous variable and compared for low (less than 250 ng/dl) vs normal (250 ng/dl or greater) groups based on the saturation model, using Kaplan-Meier survival estimates, log rank test, and Cox proportional hazards regression models incorporating established clinically important baseline factors. RESULTS On intention to treat analysis 138 (16.5%) of 838 eligible men had baseline serum testosterone less than 250 ng/dl. Key cancer characteristics for low vs normal baseline serum testosterone cohorts were comparable; Gleason sum 7-10 (55% vs 58%), stage and prostate specific antigen 20 ng/ml or greater categories (38% each). The lowest baseline serum testosterone quartile cutoff value was 282 ng/dl or less (206 patients). Multivariable analysis showed a significant baseline serum testosterone effect for all survival end points. For the saturation model low cutoff less than 250 ng/dl, significance remained for overall (HR 2.24; p <0.02) and progression-free survival (HR 1.57; p <0.02), but not for time to prostate specific antigen progression (HR 1.37; p=0.2). CONCLUSIONS Lower baseline serum testosterone was significantly associated with worse study survival end points in hormone naïve advanced prostate cancer patients undergoing continuous medical castration. Future well-designed studies should compare continuous androgen deprivation therapy (the current gold standard) with newer alternatives to optimize individualized management in these men.",2021,"For the saturation model low cut-off <250 ng/dL, significance remained for overall (HR 2.24; p <0.02) and progression free survival (HR 1.57; p <0.02), but not for time to PSA progression (HR 1.37; p=0.2). ","['Limitations', 'hormone naïve advanced prostate cancer patients receiving continuous androgen deprivation therapy', 'Hormone Naïve Advanced Prostate Cancer Patients', 'hormone naïve advanced prostate cancer patients undergoing continuous medical castration']",['continuous androgen deprivation therapy (agonist or antagonist'],"['baseline serum testosterone effect', 'time to PSA progression', 'progression free survival']","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0007344', 'cui_str': 'Gonadectomy'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0428413', 'cui_str': 'Serum testosterone measurement'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",838.0,0.436718,"For the saturation model low cut-off <250 ng/dL, significance remained for overall (HR 2.24; p <0.02) and progression free survival (HR 1.57; p <0.02), but not for time to PSA progression (HR 1.37; p=0.2). ","[{'ForeName': 'Anup', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'European School of Urology and EAU Research Foundation Clinical Studies Committee, London, UK.'}]",The Journal of urology,['10.1097/JU.0000000000001413'] 1548,33038320,Effect of restricted retail merchandising of discretionary food and beverages on population diet: a pragmatic randomised controlled trial.,"BACKGROUND The effectiveness of healthy food promotion on food and beverage sales in real-world food retail settings has been shown in randomised trials. The effectiveness of restrictions on the promotion of unhealthy food is, however, less clear. We aimed to assess the effect of restricted unhealthy food promotion, specifically those items contributing most to free sugar sales, on food and beverage sales. METHODS In this community-level pragmatic, partially randomised, parallel group trial, stores were randomly assigned by a statistician using a single sequence of random assignments to the intervention group, in which a co-designed strategy restricted merchandising of unhealthy food, or to a control group of usual retail practice. The trial was done in partnership with an organisation operating 25 stores in remote Australia. The primary analysis was based on difference in weekly sales with the strategy compared with no strategy in free sugar from all foods and beverages (g/total MJ; primary outcome), targeted food or beverages (weight and free sugars; g/total MJ), and gross profit (AU$) using mixed models. This trial is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12618001588280. FINDINGS Between June 13 and Aug 15, 2018, 20 stores were recruited; ten stores were randomly assigned to the intervention group and ten stores to the control group. The trial was done between Sept 2 and Dec 2, 2018. The Healthy Stores 2020 strategy resulted in a reduction in sales of free sugar of 2·8% (95% CI -4·9 to -0·7). Targeted beverages were reduced by 8·4% (-12·3 to -4·3) and associated free sugar by 6·8% (-10·9 to -2·6), sugar-sweetened soft drinks by 13·2% (-18·5 to -7·6), and associated free sugar by 13·4% (-18·7 to -7·7). Reductions in sales of free sugar from confectionery of 7·5% (-14·3 to -0·2) and in weight sold (-4·6%, -11·1 to 2·3) resulted; however, the reduction in weight was not statistically significant. No differences in sales of table sugar and sweet biscuits were observed. Gross profit was not impacted adversely; a small increase resulted (5·3%, 0·3 to 10·5). INTERPRETATION Restricted merchandising of unhealthy foods and beverages, while allowing for complementary merchandising of healthier foods and beverages in a real-world store setting and co-designed with retailers, can achieve both public health and business relevant gains. FUNDING Australian National Health and Medical Research Council.",2020,"Targeted beverages were reduced by 8·4% (-12·3 to -4·3) and associated free sugar by 6·8% (-10·9 to -2·6), sugar-sweetened soft drinks by 13·2% (-18·5 to -7·6), and associated free sugar by 13·4% (-18·7 to -7·7).","['partnership with an organisation operating 25 stores in remote Australia', 'Between June 13 and Aug 15, 2018, 20 stores were recruited; ten stores', 'population diet']",['restricted retail merchandising of discretionary food and beverages'],"['targeted food or beverages (weight and free sugars; g/total MJ), and gross profit (AU', 'Targeted beverages', 'sales of table sugar and sweet biscuits', 'reduction in weight', 'sales of free sugar']","[{'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0524819', 'cui_str': 'Foods and drinks'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0036070', 'cui_str': 'Sales'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0452501', 'cui_str': 'Cookie and/or cracker'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",20.0,0.138025,"Targeted beverages were reduced by 8·4% (-12·3 to -4·3) and associated free sugar by 6·8% (-10·9 to -2·6), sugar-sweetened soft drinks by 13·2% (-18·5 to -7·6), and associated free sugar by 13·4% (-18·7 to -7·7).","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Brimblecombe', 'Affiliation': 'Department of Nutrition, Dietetics and Food, Monash University, Melbourne, VIC, Australia; Menzies School of Health Research, Royal Darwin Hospital Campus, Darwin, NT, Australia. Electronic address: julie.brimblecombe@monash.edu.au.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'McMahon', 'Affiliation': 'Menzies School of Health Research, Royal Darwin Hospital Campus, Darwin, NT, Australia.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Ferguson', 'Affiliation': 'Menzies School of Health Research, Royal Darwin Hospital Campus, Darwin, NT, Australia; School of Public Health, Faculty of Medicine, The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Khia', 'Initials': 'K', 'LastName': 'De Silva', 'Affiliation': 'Arnhem Land Progress Aboriginal Corporation, Darwin, NT, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Peeters', 'Affiliation': 'Institute for Health Transformation, Deakin University, Geelong, VIC, Australia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Miles', 'Affiliation': 'Menzies School of Health Research, Royal Darwin Hospital Campus, Darwin, NT, Australia.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wycherley', 'Affiliation': 'Menzies School of Health Research, Royal Darwin Hospital Campus, Darwin, NT, Australia; Alliance for Research in Exercise, Nutrition and Activity, University of South Australia, Adelaide, SA, Australia.'}, {'ForeName': 'Leia', 'Initials': 'L', 'LastName': 'Minaker', 'Affiliation': 'School of Planning, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Greenacre', 'Affiliation': 'Business School, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Gunther', 'Affiliation': 'Menzies School of Health Research, Royal Darwin Hospital Campus, Darwin, NT, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Chappell', 'Affiliation': 'Arnhem Land Progress Aboriginal Corporation, Darwin, NT, Australia.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Chatfield', 'Affiliation': 'Menzies School of Health Research, Royal Darwin Hospital Campus, Darwin, NT, Australia; School of Public Health, Faculty of Medicine, The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Mah', 'Affiliation': 'Faculty of Health, Dalhousie University, Halifax, NS, Canada; Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}]",The Lancet. Planetary health,['10.1016/S2542-5196(20)30202-3'] 1549,33044367,"Effects of Curcumin and Fenugreek Soluble Fiber on the Physical Working Capacity at the Fatigue Threshold, Peak Oxygen Consumption, and Time to Exhaustion.","Herrick, LP, Goh, J, Menke, W, Campbell, MS, Fleenor, BS, Abel, MG, and Bergstrom, HC. Effects of curcumin and fenugreek soluble fiber on the physical working capacity at the fatigue threshold, peak oxygen consumption, and time to exhaustion. J Strength Cond Res 34(12): 3346-3355, 2020-The purpose of this study was to examine the effects of curcumin in combination with fenugreek soluble fiber (CUR + FEN) or fenugreek soluble fiber alone (FEN) on the neuromuscular fatigue threshold (PWCFT), peak oxygen consumption (V˙o2peak), and time to exhaustion (Tlim) on a graded exercise test (GXT), in untrained subjects. The PWCFT estimates the highest power output that can be maintained without evidence of neuromuscular fatigue. Forty-seven untrained, college-aged subjects were randomly assigned to one of 3 supplementation groups; placebo (PLA, n = 15), CUR + FEN (500 mg·d, n = 18), or FEN (300 mg·d, n = 14). The subjects completed a maximal GXT on a cycle ergometer to determine the PWCFT, V˙o2peak, and Tlim before (PRE) and after (POST) 28 days of daily supplementation. Surface electromyographic signals were recorded from a bipolar electrode arrangement on the vastus lateralis of the right leg during each test. Separate one-way analysis of covariances were used to determine if there were between-group differences for adjusted POST-PWCFT, POST-V˙o2peak, and POST-Tlim values, covaried for the respective PRE-test scores. The adjusted POST-PWCFT for the CUR + FEN group (mean ± SD: 196 ± 58 W) was greater (p = 0.016) than the PLA group (168 ± 49 W) but the FEN group (185 ± 32 W) was not different from the CUR + FEN or PLA groups (p > 0.05). There were no differences for adjusted POST-V˙o2peak (p = 0.612) or POST-Tlim (p = 0.508) among the groups. These findings suggested curcumin combined with fenugreek soluble fiber might delay neuromuscular fatigue.",2020,There were no differences for adjusted POST-,"['Forty-seven untrained, college-aged subjects', 'untrained subjects']","['V[Combining', 'placebo (PLA, n = 15), CUR + FEN', 'curcumin in combination with fenugreek soluble fiber (CUR + FEN) or fenugreek soluble fiber alone (FEN', 'J Strength Cond Res XX(X', 'maximal GXT', 'Curcumin and Fenugreek Soluble Fiber', 'FEN', 'graded exercise test (GXT', 'curcumin and fenugreek soluble fiber']","['Surface electromyographic signals', 'adjusted POST', 'Physical Working Capacity at the Fatigue Threshold, Peak Oxygen Consumption, and Time to Exhaustion', 'Herrick, LP, Goh, J, Menke, W, Campbell, MS, Fleenor, BS, Abel, MG, and Bergstrom, HC', 'neuromuscular fatigue threshold (PWCFT), peak oxygen consumption ', 'Dot Above]o2peak), and time to exhaustion (Tlim', 'physical working capacity at the fatigue threshold, peak oxygen consumption, and time to exhaustion', 'Dot Above]o2peak, and Tlim before (PRE']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0557806', 'cui_str': 'College'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0060207', 'cui_str': 'Fenugreek'}, {'cui': 'C3661727', 'cui_str': 'Soluble fiber'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0022716', 'cui_str': 'Menkes kinky-hair syndrome'}, {'cui': 'C0234116', 'cui_str': 'Neuromuscular fatigue'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial dots'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]",,0.0301262,There were no differences for adjusted POST-,"[{'ForeName': 'Lauren P', 'Initials': 'LP', 'LastName': 'Herrick', 'Affiliation': 'Department of Kinesiology and Health Promotion, University of Kentucky, Lexington, Kentucky; and.'}, {'ForeName': 'Jensen', 'Initials': 'J', 'LastName': 'Goh', 'Affiliation': 'Department of Kinesiology and Health Promotion, University of Kentucky, Lexington, Kentucky; and.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Menke', 'Affiliation': 'Department of Kinesiology and Health Promotion, University of Kentucky, Lexington, Kentucky; and.'}, {'ForeName': 'Marilyn S', 'Initials': 'MS', 'LastName': 'Campbell', 'Affiliation': 'Department of Kinesiology and Health Promotion, University of Kentucky, Lexington, Kentucky; and.'}, {'ForeName': 'Bradley S', 'Initials': 'BS', 'LastName': 'Fleenor', 'Affiliation': 'Ball State University, School of Kinesiology, Muncie, Indiana.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Abel', 'Affiliation': 'Department of Kinesiology and Health Promotion, University of Kentucky, Lexington, Kentucky; and.'}, {'ForeName': 'Haley C', 'Initials': 'HC', 'LastName': 'Bergstrom', 'Affiliation': 'Department of Kinesiology and Health Promotion, University of Kentucky, Lexington, Kentucky; and.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003852'] 1550,33040741,Use of simulations to evaluate the effectiveness of barrier precautions to prevent patient-to-patient transfer of healthcare-associated pathogens.,"BACKGROUND There is controversy regarding whether the addition of cover gowns offers a substantial benefit over gloves alone in reducing personnel contamination and preventing pathogen transmission. DESIGN Simulated patient care interactions. OBJECTIVE To evaluate the efficacy of different types of barrier precautions and to identify routes of transmission. METHODS In randomly ordered sequence, 30 personnel each performed 3 standardized examinations of mannequins contaminated with pathogen surrogate markers (cauliflower mosaic virus DNA, bacteriophage MS2, nontoxigenic Clostridioides difficile spores, and fluorescent tracer) while wearing no barriers, gloves, or gloves plus gowns followed by examination of a noncontaminated mannequin. We compared the frequency and routes of transfer of the surrogate markers to the second mannequin or the environment. RESULTS For a composite of all surrogate markers, transfer by hands occurred at significantly lower rates in the gloves-alone group (OR, 0.02; P < .001) and the gloves-plus-gown group (OR, 0.06; P = .002). Transfer by stethoscope diaphragms was common in all groups and was reduced by wiping the stethoscope between simulations (OR, 0.06; P < .001). Compared to the no-barriers group, wearing a cover gown and gloves resulted in reduced contamination of clothing (OR, 0.15; P < .001), but wearing gloves alone did not. CONCLUSIONS Wearing gloves alone or gloves plus gowns reduces hand transfer of pathogens but may not address transfer by devices such as stethoscopes. Cover gowns reduce the risk of contaminating the clothing of personnel.",2021,"For a composite of all surrogate markers, transfer by hands occurred at significantly lower rates in the gloves-alone group (OR, 0.02; P < .001) and the gloves-plus-gown group (OR, 0.06; P = .002).",[],"['mannequins contaminated with pathogen surrogate markers (cauliflower mosaic virus DNA, bacteriophage MS2, nontoxigenic Clostridioides difficile spores, and fluorescent tracer) while wearing no barriers, gloves, or gloves plus gowns followed by examination of a noncontaminated mannequin']",['reduced contamination of clothing'],[],"[{'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0205279', 'cui_str': 'Contaminated'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0086589', 'cui_str': 'Marker, Surrogate'}, {'cui': 'C1456463', 'cui_str': 'Cauliflower mosaic virus'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0206390', 'cui_str': 'Enterobacteria phage MS2'}, {'cui': 'C0079134', 'cui_str': 'Clostridium difficile (bacteria)'}, {'cui': 'C0038027', 'cui_str': 'Spores'}, {'cui': 'C0303920', 'cui_str': 'Fluorescent stain'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0206069', 'cui_str': 'Glove'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0181064', 'cui_str': 'Gown'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0009072', 'cui_str': 'Garments'}]",,0.0713151,"For a composite of all surrogate markers, transfer by hands occurred at significantly lower rates in the gloves-alone group (OR, 0.02; P < .001) and the gloves-plus-gown group (OR, 0.06; P = .002).","[{'ForeName': 'Heba', 'Initials': 'H', 'LastName': 'Alhmidi', 'Affiliation': 'Research Service, Louis Stokes Cleveland VA Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Li', 'Affiliation': 'Research Service, Louis Stokes Cleveland VA Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Cadnum', 'Affiliation': 'Research Service, Louis Stokes Cleveland VA Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Muhammed F', 'Initials': 'MF', 'LastName': 'Haq', 'Affiliation': 'Research Service, Louis Stokes Cleveland VA Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Natalia C', 'Initials': 'NC', 'LastName': 'Pinto-Herrera', 'Affiliation': 'Research Service, Louis Stokes Cleveland VA Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Brigid M', 'Initials': 'BM', 'LastName': 'Wilson', 'Affiliation': 'Geriatric Research, Education and Clinical Center, Louis Stokes Cleveland VA Medical Center, Cleveland, OH.'}, {'ForeName': 'Curtis J', 'Initials': 'CJ', 'LastName': 'Donskey', 'Affiliation': 'Case Western Reserve University School of Medicine, Cleveland, Ohio.'}]",Infection control and hospital epidemiology,['10.1017/ice.2020.1215'] 1551,33046475,Effects of a power strength training using elastic resistance exercises on the motor and non-motor symptoms in patients with Parkinson's disease H&Y 1-3: study protocol for a randomised controlled trial (PARK-BAND Study).,"INTRODUCTION Parkinson's disease (PD) is the second most common neurodegenerative disorder in Brazil. Physical activity is a complementary intervention in managing inherent declines associated with the disease like strength, balance, gait, and functionality and benefit health-related outcomes. Here, we report the PARK-BAND Study protocol, which aims to investigate potential benefits of power training using elastic devices in participants with PD. Our intervention will be provided in patients with PD using elastic devices like elastic bands and tubes. Therefore, we used the term Park from Parkinson's disease and band from elastic bands. METHODS AND ANALYSIS This randomised single-blind single-centre two-arm parallel, superiority trial will include 50 participants with PD attending the clinical setting. Those who meet the eligibility criteria and provide consent to participate will be randomised in a 1:1 ratio to either the exercise group, which will receive power training programme or the health education group, which will receive the education programme. Randomisation will be performed by permuted block randomisation with a block size of eight. Both groups will receive a 12-week intervention. The exercise group will have two sessions per week and the health education group will have one session per week. Changes from baseline in bradykinesia, as assessed by the Unified Parkinson's Disease Rating Scale motor examination subscore and physical functional performance, will be the primary outcomes. Secondary outcomes include other neurological, neurophysiological and physical variables, as well as the quality of life, depression, cognition, sleep quality and disturbances, assessed before and after interventions. We hypothesise that the exercise group will have greater improvement in primary and secondary outcomes than the health education group. ETHICS AND DISSEMINATION The study is approved by the Research Ethics Committee of Hospital Universitário Walter Cantidio and all participants will provide their written informed consent (register number 91075318.1.0000.5045).Trial results will be disseminated via peer reviewed journal articles and conference presentations, reports for organisations involved with PD and for participants. TRIAL REGISTRATION NUMBER Registro Brasileiro de Ensaios Clínicos Registry (RBR-5w2sqt); Pre-results.",2020,"Changes from baseline in bradykinesia, as assessed by the Unified Parkinson's Disease Rating Scale motor examination subscore and physical functional performance, will be the primary outcomes.","['50 participants with PD attending the clinical setting', ""patients with Parkinson's disease H&Y 1-3"", 'participants with PD']","['power training using elastic devices', 'power training programme or the health education group, which will receive the education programme', 'power strength training using elastic resistance exercises']","[""Unified Parkinson's Disease Rating Scale motor examination subscore and physical functional performance"", 'motor and non-motor symptoms', 'neurological, neurophysiological and physical variables, as well as the quality of life, depression, cognition, sleep quality and disturbances, assessed before and after interventions']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0150375', 'cui_str': 'Group education'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4704690', 'cui_str': 'Physical Functional Performance'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",50.0,0.0963442,"Changes from baseline in bradykinesia, as assessed by the Unified Parkinson's Disease Rating Scale motor examination subscore and physical functional performance, will be the primary outcomes.","[{'ForeName': 'Danielle Pessoa', 'Initials': 'DP', 'LastName': 'Lima', 'Affiliation': 'Geriatric Division, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil dra.daniellelima@gmail.com.'}, {'ForeName': 'Samuel Brito', 'Initials': 'SB', 'LastName': 'de Almeida', 'Affiliation': 'Clinical Research Unit, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil.'}, {'ForeName': 'Janine de Carvalho', 'Initials': 'JC', 'LastName': 'Bonfadini', 'Affiliation': 'Clinical Research Unit, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil.'}, {'ForeName': 'Emmanuelle Silva Tavares', 'Initials': 'EST', 'LastName': 'Sobreira', 'Affiliation': 'Clinical Research Unit, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil.'}, {'ForeName': 'Patrícia Gomes', 'Initials': 'PG', 'LastName': 'Damasceno', 'Affiliation': 'Division of Neurology, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil.'}, {'ForeName': 'Antonio Brazil', 'Initials': 'AB', 'LastName': 'Viana Júnior', 'Affiliation': 'Clinical Research Unit, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil.'}, {'ForeName': 'Madeleine Sales', 'Initials': 'MS', 'LastName': 'de Alencar', 'Affiliation': 'Geriatric Division, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil.'}, {'ForeName': 'João Rafael Gomes', 'Initials': 'JRG', 'LastName': 'de Luna', 'Affiliation': 'Geriatric Division, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil.'}, {'ForeName': 'Pedro Gustavo Barros', 'Initials': 'PGB', 'LastName': 'Rodrigues', 'Affiliation': 'Medical School, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil.'}, {'ForeName': 'Isabelle de Sousa', 'Initials': 'IS', 'LastName': 'Pereira', 'Affiliation': 'Medical School, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil.'}, {'ForeName': 'André Luis de Castro', 'Initials': 'ALC', 'LastName': 'Gadelha', 'Affiliation': 'Psychology School, Universidade de Fortaleza, Centro de Ciências da Saúde, Fortaleza, Brazil.'}, {'ForeName': 'Liliane Maria', 'Initials': 'LM', 'LastName': 'de Oliveira', 'Affiliation': 'School of Kinesiology, Universidade Estácio de Sá Sistema Integrado de Bibliotecas do Centro Universitário Estácio do Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Érica Carneiro Barbosa', 'Initials': 'ÉCB', 'LastName': 'Chaves', 'Affiliation': 'School of Kinesiology, Universidade Estácio de Sá Sistema Integrado de Bibliotecas do Centro Universitário Estácio do Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Vlademir Gomes', 'Initials': 'VG', 'LastName': 'Carneiro', 'Affiliation': 'School of Kinesiology, Universidade Federal da Paraíba, Joao Pessoa, Brazil.'}, {'ForeName': 'Rayane Rodrigues', 'Initials': 'RR', 'LastName': 'Monteiro', 'Affiliation': 'School of Kinesiology, Universidade Estácio de Sá Sistema Integrado de Bibliotecas do Centro Universitário Estácio do Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Thatyara Almeida de Macedo', 'Initials': 'TAM', 'LastName': 'Costa', 'Affiliation': 'School of Nutrition, Universidade Estácio de Sá Sistema Integrado de Bibliotecas do Centro Universitário Estácio do Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Helal', 'Affiliation': 'School of Kinesiology, Universidade do Extremo Sul Catarinense, Criciuma, Brazil.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Signorile', 'Affiliation': 'Kinesiology and Sport Sciences, University of Miami, Coral Gables, Florida, USA.'}, {'ForeName': 'Lidiane Andréa Oliveira', 'Initials': 'LAO', 'LastName': 'Lima', 'Affiliation': 'Department of Physiotherapy, Universidade Federal do Ceará, Fortaleza, Brazil.'}, {'ForeName': 'Manoel Alves', 'Initials': 'MA', 'LastName': 'Sobreira-Neto', 'Affiliation': 'Division of Neurology, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Braga-Neto', 'Affiliation': 'Division of Neurology, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil.'}]",BMJ open,['10.1136/bmjopen-2020-039941'] 1552,33046478,Protocol of a randomised controlled trial on the efficacy of medication optimisation in elderly inpatients: medication optimisation protocol efficacy for geriatric inpatients (MPEG) trial.,"INTRODUCTION Whether medication optimisation improves clinical outcomes in elderly individuals remains unclear. The current study aims to evaluate the effect of multidisciplinary team-based medication optimisation on survival, rehospitalisation and unscheduled hospital visits in elderly patients. METHODS AND ANALYSIS We report the protocol of a single-centre, open-label, randomised controlled trial. The enrolled subjects will be medical inpatients, aged 65 years or older, admitted to a community hospital and receiving five or more regular medications. The participants will be randomly assigned to receive either an intervention for medication optimisation or the usual care. The intervention will consist of a multidisciplinary team-based medication review, followed by a medication optimisation proposal based on the Screening Tool of Older Persons' potentially inappropriate Prescriptions/Screening Tool to Alert doctors to the Right Treatment criteria and an implicit medication optimisation protocol. Medication optimisation summaries will be sent to primary care physicians and community pharmacists on discharge. The primary outcome will be a composite of death, unscheduled hospital visits and rehospitalisation until 48 weeks after randomisation. Secondary outcomes will include each of the primary endpoints, the number of prescribed medications, quality of life score, level of long-term care required, drug-related adverse events, death during hospitalisation and falls. Participants will be followed up for 48 weeks with bimonthly telephone interviews to assess the primary and secondary outcomes. A log-rank test stratified by randomisation factors will be used to compare the incidence of the composite endpoint. The study was initiated in 2019 and a minimum of 500 patients will be enrolled. ETHICS AND DISSEMINATION The study protocol has been approved by the Institutional Ethical Committee of St. Marianna University School of Medicine (No. 4129). The results of the current study will be submitted to a peer-reviewed journal. TRIAL REGISTRATION NUMBER UMIN000035265.",2020,"The primary outcome will be a composite of death, unscheduled hospital visits and rehospitalisation until 48 weeks after randomisation.","['elderly inpatients', 'elderly patients', 'enrolled subjects will be medical inpatients, aged 65 years or older, admitted to a community hospital and receiving five or more regular medications', '500 patients will be enrolled', 'elderly individuals', 'geriatric inpatients (MPEG) trial']","['multidisciplinary team-based medication optimisation', 'intervention for medication optimisation or the usual care']","['survival, rehospitalisation and unscheduled hospital visits', 'composite of death, unscheduled hospital visits and rehospitalisation until 48 weeks after randomisation', 'number of prescribed medications, quality of life score, level of long-term care required, drug-related adverse events, death during hospitalisation and falls']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",,0.142518,"The primary outcome will be a composite of death, unscheduled hospital visits and rehospitalisation until 48 weeks after randomisation.","[{'ForeName': 'Kenya', 'Initials': 'K', 'LastName': 'Ie', 'Affiliation': 'Division of General Internal Medicine, Department of Internal Medicine, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan kenya.ie@marianna-u.ac.jp.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Hirose', 'Affiliation': 'Division of General Internal Medicine, Department of Internal Medicine, St Marianna University School of Medicine, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Tsubasa', 'Initials': 'T', 'LastName': 'Sakai', 'Affiliation': 'Division of General Internal Medicine, Department of Internal Medicine, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Iori', 'Initials': 'I', 'LastName': 'Motohashi', 'Affiliation': 'Division of General Internal Medicine, Department of Internal Medicine, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Aihara', 'Affiliation': 'Division of General Internal Medicine, Department of Internal Medicine, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Otsuki', 'Affiliation': 'Division of General Internal Medicine, Department of Internal Medicine, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Tsuboya', 'Affiliation': 'Department of Pharmacy, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Pharmacy, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Hikari', 'Initials': 'H', 'LastName': 'Hashi', 'Affiliation': 'Department of Pharmacy, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Eisuke', 'Initials': 'E', 'LastName': 'Inoue', 'Affiliation': 'Showa University Research Administration Center, Showa University, Shinagawa-ku, Tokyo, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Division of Medical Informatics, St. Marianna University School of Medicine, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Eiko', 'Initials': 'E', 'LastName': 'Komiya', 'Affiliation': 'Department of Pharmacy, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Itoh', 'Affiliation': 'Department of Pharmacy, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Tomoya', 'Initials': 'T', 'LastName': 'Tsuchida', 'Affiliation': 'Division of General Internal Medicine, Department of Internal Medicine, St Marianna University School of Medicine, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Eri', 'Initials': 'E', 'LastName': 'Kurosu', 'Affiliation': 'Division of General Internal Medicine, Department of Internal Medicine, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Albert', 'Affiliation': 'Department of Behavioral and Community Health Sciences, University of Pittsburgh Graduate School of Public Health, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Chiaki', 'Initials': 'C', 'LastName': 'Okuse', 'Affiliation': 'Division of General Internal Medicine, Department of Internal Medicine, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Takahide', 'Initials': 'T', 'LastName': 'Matsuda', 'Affiliation': 'Division of General Internal Medicine, Department of Internal Medicine, St Marianna University School of Medicine, Kawasaki-shi, Kanagawa, Japan.'}]",BMJ open,['10.1136/bmjopen-2020-041125'] 1553,33047971,"Intraoperative 99mTc-MIBI-Guided Parathyroidectomy Improves Curative Effect of Parathyroidectomy, Bone Metabolism, and Bone Mineral Density.","This study aimed to compare the postoperative effects of total parathyroidectomy plus forearm transplantation and radioguided parathyroidectomy on bone metabolism and bone mineral density (BMD). From June 2013 to October 2017, 67 patients with renal secondary hyperparathyroidism (SHPT) received surgical treatment. The control group included 30 cases of classical total parathyroidectomy plus forearm transplantation for SHPT. In the experimental group, 37 patients underwent 99mTc-MIBI-guided parathyroidectomy. Demographics, parathyroid hormone (PTH) level, blood calcium level, and pathological results were compared between the 2 groups. The curative effect of parathyroidectomy and its effect on BMD were also compared. The BMDs in the L1-L4 segments and femoral neck in both groups were significantly improved after operation (all P < .05). The T scores of the L1-L4 segments and femoral neck in both groups were significantly improved after operation (all P < .05). The improvement in the T score of the L4 in the experimental group was significantly higher than that in the control group ( P < .05). No significant differences in the improvement in the L1-L3 segments and femoral neck were found between the 2 groups. Both traditional total parathyroidectomy plus forearm transplantation and 99mTc-MIBI-guided parathyroidectomy can improve PTH level, blood calcium level, phosphorus level, bone metabolism, and BMD to varying degrees in patients with SHPT. Compared with the traditional surgery, 99mTc-MIBI-guided parathyroidectomy can improve blood calcium and phosphorus metabolisms, reduce PTH level, and improve the T scores of L4 to a greater extent.",2021,No significant differences in the improvement in the L1-L3 segments and femoral neck were found between the 2 groups.,"['37 patients underwent', 'From June 2013 to October 2017, 67 patients with renal secondary hyperparathyroidism (SHPT) received surgical treatment', 'patients with SHPT']","['traditional total parathyroidectomy plus forearm transplantation and 99mTc-MIBI-guided parathyroidectomy', 'parathyroidectomy', 'total parathyroidectomy plus forearm transplantation and radioguided parathyroidectomy', 'Intraoperative 99mTc-MIBI-Guided Parathyroidectomy', '99mTc-MIBI-guided parathyroidectomy', 'classical total parathyroidectomy plus forearm transplantation for SHPT']","['T score of the L4', 'bone metabolism and bone mineral density (BMD', 'T scores of the L1-L4 segments and femoral neck', 'Demographics, parathyroid hormone (PTH) level, blood calcium level, and pathological results', 'L1-L3 segments and femoral neck', 'PTH level, blood calcium level, phosphorus level, bone metabolism, and BMD', 'blood calcium and phosphorus metabolisms, reduce PTH level', 'Parathyroidectomy, Bone Metabolism, and Bone Mineral Density', 'BMD', 'BMDs in the L1-L4 segments and femoral neck']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271847', 'cui_str': 'Hyperparathyroidism due to renal insufficiency'}, {'cui': 'C0020503', 'cui_str': 'Secondary hyperparathyroidism'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0193696', 'cui_str': 'Complete parathyroidectomy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C1692878', 'cui_str': '99mTc(HYNICtide)(tricine)(TPPTS)'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0079989', 'cui_str': 'Parathyroidectomy'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0020503', 'cui_str': 'Secondary hyperparathyroidism'}]","[{'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0729820', 'cui_str': 'Blood calcium measurement'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0079989', 'cui_str': 'Parathyroidectomy'}]",67.0,0.0195953,No significant differences in the improvement in the L1-L3 segments and femoral neck were found between the 2 groups.,"[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': '56694 Department of Head and Neck Surgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Jialin', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': '56694 Department of Head and Neck Surgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Qinyi', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': '56694 Department of Head and Neck Surgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Zheng', 'Affiliation': '56694 Department of Head and Neck Surgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Xiangchao', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': '56694 Department of Bone and Joint Surgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': '56694 Department of Bone and Joint Surgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Jiadong', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': '56694 Department of Head and Neck Surgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}]",The American surgeon,['10.1177/0003134820951467'] 1554,33051044,Taurine supplementation associated with exercise increases mitochondrial activity and fatty acid oxidation gene expression in the subcutaneous white adipose tissue of obese women.,"PURPOSE To evaluate the effects of taurine supplementation associated or not with chronic exercise on body composition, mitochondrial function, and expression of genes related to mitochondrial activity and lipid oxidation in the subcutaneous white adipose tissue (scWAT) of obese women. METHODS A randomized and double-blind trial was developed with 24 obese women (BMI 33.1 ± 2.9 kg/m 2 , 32.9 ± 6.3 y) randomized into three groups: Taurine supplementation group (Tau, n = 8); Exercise group (Ex, n = 8); Taurine supplementation + exercise group (TauEx, n = 8). The intervention was composed of 3 g of taurine or placebo supplementation and exercise training for eight weeks. Anthropometry, body fat composition, indirect calorimetry, scWAT biopsy for mitochondrial respiration, and gene expression related to mitochondrial activity and lipid oxidation were assessed before and after the intervention. RESULTS No changes were observed for the anthropometric characteristics. The Ex group presented an increased resting energy expenditure rate, and the TauEx and Ex groups presented increased lipid oxidation and a decreased respiratory quotient. Both trained groups (TauEx and Ex) demonstrated improved scWAT mitochondrial respiratory capacity. Regarding mitochondrial markers, no changes were observed for the Tau group. The TauEx group had higher expression of CIDEA, PGC1a, PRDM16, UCP1, and UCP2. The genes related to fat oxidation (ACO2 and ACOX1) were increased in the Tau and Ex groups, while only the TauEx group presented increased expression of CPT1, PPARa, PPARγ, LPL, ACO1, ACO2, HSL, ACOX1, and CD36 genes. CONCLUSION Taurine supplementation associated with exercise improved lipid metabolism through the modulation of genes related to mitochondrial activity and fatty acid oxidation, suggesting a browning effect in the scWAT of obese women.",2021,"The genes related to fat oxidation (ACO2 and ACOX1) were increased in the Tau and Ex groups, while only the TauEx group presented increased expression of CPT1, PPARa, PPARγ, LPL, ACO1, ACO2, HSL, ACOX1, and CD36 genes. ","['obese women', '24 obese women (BMI 33.1\xa0±\xa02.9\xa0kg/m 2 , 32.9\xa0±\xa06.3']","['taurine or placebo supplementation and exercise training', 'Taurine supplementation group (Tau, n\xa0=\xa08); Exercise group (Ex, n\xa0=\xa08); Taurine supplementation\xa0+\xa0exercise group (TauEx, n\xa0=\xa08', 'Taurine supplementation', 'taurine supplementation']","['fat oxidation (ACO2 and ACOX1', 'resting energy expenditure rate', 'higher expression of CIDEA, PGC1a, PRDM16, UCP1, and UCP2', 'expression of CPT1, PPARa, PPARγ, LPL, ACO1, ACO2, HSL, ACOX1, and CD36 genes', 'lipid metabolism', 'mitochondrial activity and fatty acid oxidation gene expression', 'lipid oxidation and a decreased respiratory quotient', 'Anthropometry, body fat composition, indirect calorimetry, scWAT biopsy for mitochondrial respiration, and gene expression related to mitochondrial activity and lipid oxidation', 'body composition, mitochondrial function, and expression of genes related to mitochondrial activity and lipid oxidation', 'scWAT mitochondrial respiratory capacity']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517641', 'cui_str': '2.9'}, {'cui': 'C4319697', 'cui_str': '6.3'}]","[{'cui': 'C0039350', 'cui_str': 'Taurine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0023816', 'cui_str': 'Lipoprotein lipase'}, {'cui': 'C0054954', 'cui_str': 'Lymphocyte antigen CD36'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0006781', 'cui_str': 'Indirect calorimetry'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1704223', 'cui_str': 'White Adipose Tissue'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",24.0,0.0708696,"The genes related to fat oxidation (ACO2 and ACOX1) were increased in the Tau and Ex groups, while only the TauEx group presented increased expression of CPT1, PPARa, PPARγ, LPL, ACO1, ACO2, HSL, ACOX1, and CD36 genes. ","[{'ForeName': 'Flavia Giolo', 'Initials': 'FG', 'LastName': 'De Carvalho', 'Affiliation': 'School of Physical Education and Sport of Ribeirao Preto, University of Sao Paulo -EEFERP USP, Ribeirao Preto, Sao Paulo, Brazil.'}, {'ForeName': 'Camila Fernanda Cunha', 'Initials': 'CFC', 'LastName': 'Brandao', 'Affiliation': 'Internal Medicine Department, Ribeirao Preto Medical School, University of Sao Paulo - FMRP USP, Ribeirao Preto, Sao Paulo, Brazil; State University of Minas Gerais - UEMG, Divinopolis, Minas Gerais, Brazil.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Batitucci', 'Affiliation': 'Department of Food and Nutrition, School of Pharmaceutical Sciences of Araraquara, State University of Sao Paulo - FCF UNESP, Araraquara, Sao Paulo, Brazil.'}, {'ForeName': 'Anderson de Oliveira', 'Initials': 'AO', 'LastName': 'Souza', 'Affiliation': 'Department of BioMolecular Sciences, Faculty of Pharmaceutical Sciences of Ribeirao Preto, University of Sao Paulo - FCFRP USP, Ribeirao Preto, Sao Paulo, Brazil.'}, {'ForeName': 'Gustavo Duarte', 'Initials': 'GD', 'LastName': 'Ferrari', 'Affiliation': 'Department of BioMolecular Sciences, Faculty of Pharmaceutical Sciences of Ribeirao Preto, University of Sao Paulo - FCFRP USP, Ribeirao Preto, Sao Paulo, Brazil.'}, {'ForeName': 'Luciane Carla', 'Initials': 'LC', 'LastName': 'Alberici', 'Affiliation': 'Department of BioMolecular Sciences, Faculty of Pharmaceutical Sciences of Ribeirao Preto, University of Sao Paulo - FCFRP USP, Ribeirao Preto, Sao Paulo, Brazil.'}, {'ForeName': 'Vitor Rosetto', 'Initials': 'VR', 'LastName': 'Muñoz', 'Affiliation': 'Laboratory of Molecular Biology of Exercise, University of Campinas - FCA UNICAMP, Limeira, Sao Paulo, Brazil.'}, {'ForeName': 'José Rodrigo', 'Initials': 'JR', 'LastName': 'Pauli', 'Affiliation': 'Laboratory of Molecular Biology of Exercise, University of Campinas - FCA UNICAMP, Limeira, Sao Paulo, Brazil.'}, {'ForeName': 'Leandro Pereira', 'Initials': 'LP', 'LastName': 'De Moura', 'Affiliation': 'Laboratory of Molecular Biology of Exercise, University of Campinas - FCA UNICAMP, Limeira, Sao Paulo, Brazil.'}, {'ForeName': 'Eduardo Rochete', 'Initials': 'ER', 'LastName': 'Ropelle', 'Affiliation': 'Laboratory of Molecular Biology of Exercise, University of Campinas - FCA UNICAMP, Limeira, Sao Paulo, Brazil.'}, {'ForeName': 'Adelino Sanchez Ramos', 'Initials': 'ASR', 'LastName': 'da Silva', 'Affiliation': 'School of Physical Education and Sport of Ribeirao Preto, University of Sao Paulo -EEFERP USP, Ribeirao Preto, Sao Paulo, Brazil.'}, {'ForeName': 'Marcia Varella Morandi', 'Initials': 'MVM', 'LastName': 'Junqueira-Franco', 'Affiliation': 'Internal Medicine Department, Ribeirao Preto Medical School, University of Sao Paulo - FMRP USP, Ribeirao Preto, Sao Paulo, Brazil.'}, {'ForeName': 'Julio Sergio', 'Initials': 'JS', 'LastName': 'Marchini', 'Affiliation': 'Internal Medicine Department, Ribeirao Preto Medical School, University of Sao Paulo - FMRP USP, Ribeirao Preto, Sao Paulo, Brazil.'}, {'ForeName': 'Ellen Cristini', 'Initials': 'EC', 'LastName': 'de Freitas', 'Affiliation': 'School of Physical Education and Sport of Ribeirao Preto, University of Sao Paulo -EEFERP USP, Ribeirao Preto, Sao Paulo, Brazil; Department of Food and Nutrition, School of Pharmaceutical Sciences of Araraquara, State University of Sao Paulo - FCF UNESP, Araraquara, Sao Paulo, Brazil. Electronic address: ellenfreitas@usp.br.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.09.044'] 1555,33053626,"Effect of Food Containing Paramylon Derived from Euglena gracilis EOD-1 on Fatigue in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial.","Euglena gracilis EOD-1, a kind of microalgae, is known to contain a high proportion of paramylon, a type of β-1,3-glucan. Paramylon derived from E. gracilis EOD-1 is presumed to suppress cellular oxidative injury and expected to reduce fatigue and fatigue sensation. Therefore, we aimed to examine whether food containing paramylon derived from E. gracilis EOD-1 (EOD-1PM) ingestion reduced fatigue and fatigue sensation in healthy adults. We conducted a randomized, double-blind, placebo-controlled, parallel-group comparison study in 66 healthy men and women who ingested a placebo or EOD-1PM daily for 4 weeks (daily life fatigue). Furthermore, at the examination days of 0 and 4 weeks, tolerance to fatigue load was evaluated using mental tasks (task-induced fatigue). We evaluated fatigue sensation using the Visual Analogue Scale, the work efficiency of the advanced trail making test and measured serum antioxidant markers. The EOD-1PM group showed significantly lower levels of physical and mental fatigue sensations and higher levels of work efficiency as well as serum biological antioxidant potential levels than the placebo group. These results indicate that EOD-1PM ingestion reduced fatigue and fatigue sensation, which may be due to an increase in antioxidant potential and maintenance of selective attention during work.",2020,The EOD-1PM group showed significantly lower levels of physical and mental fatigue sensations and higher levels of work efficiency as well as serum biological antioxidant potential levels than the placebo group.,"['Healthy Adults', 'daily for 4 weeks (daily life fatigue', 'healthy adults', '66 healthy men and women who ingested a']","['Food Containing Paramylon', 'EOD-1PM', 'placebo or EOD-1PM', 'EOD-1PM ingestion', 'food containing paramylon derived from E. gracilis EOD-1 (EOD-1PM) ingestion', 'placebo', 'Placebo']","['tolerance to fatigue load', 'fatigue sensation', 'levels of physical and mental fatigue sensations', 'fatigue and fatigue sensation', 'serum biological antioxidant potential levels']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0070074', 'cui_str': 'paramylon'}, {'cui': 'C1509133', 'cui_str': 'post meridiem'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0224439', 'cui_str': 'Structure of gracilis muscle'}]","[{'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C4049351', 'cui_str': 'Biological antioxidant potential'}]",66.0,0.441904,The EOD-1PM group showed significantly lower levels of physical and mental fatigue sensations and higher levels of work efficiency as well as serum biological antioxidant potential levels than the placebo group.,"[{'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Kawano', 'Affiliation': 'Kobelco Eco-Solutions Co., Ltd., Kobe, Hyogo 651-2241, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Naito', 'Affiliation': 'Kobelco Eco-Solutions Co., Ltd., Kobe, Hyogo 651-2241, Japan.'}, {'ForeName': 'Machiko', 'Initials': 'M', 'LastName': 'Nishioka', 'Affiliation': 'Kobelco Eco-Solutions Co., Ltd., Kobe, Hyogo 651-2241, Japan.'}, {'ForeName': 'Norihisa', 'Initials': 'N', 'LastName': 'Nishida', 'Affiliation': 'Kobelco Eco-Solutions Co., Ltd., Kobe, Hyogo 651-2241, Japan.'}, {'ForeName': 'Madoka', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Kobelco Eco-Solutions Co., Ltd., Kobe, Hyogo 651-2241, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Kashiwagi', 'Affiliation': 'Soiken. Inc., Toyonaka, Osaka 560-0082, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Sugino', 'Affiliation': 'Soiken. Inc., Toyonaka, Osaka 560-0082, Japan.'}, {'ForeName': 'Yasuyoshi', 'Initials': 'Y', 'LastName': 'Watanabe', 'Affiliation': 'RIKEN Center for Biosystems Dynamics Research, Kobe, Hyogo 650-0047, Japan.'}]",Nutrients,['10.3390/nu12103098'] 1556,33260253,Effects of commercial metronidazole and metronidazole benzoate suspensions on food intake in chinchillas.,"OBJECTIVES To evaluate if commercially available metronidazole and metronidazole benzoate suspensions cause a reduction in food intake in healthy chinchillas and if the reduction in food intake is dose-dependent. MATERIALS AND METHODS Twelve chinchillas were used in a randomised, controlled, blinded, complete-crossover study. All treatments were administered orally every 12 hours for 3 days. Metronidazole (125 mg/mL) was administered at 20 mg/kg and metronidazole benzoate (25 mg/mL) was administered at 20 and 10 mg/kg. Food intake was recorded daily. The washout period between treatments was at least 14 days. RESULTS At 20 mg/kg PO q12h administration of both commercial suspensions resulted in a significant reduction of food intake. The greatest mean reduction in food intake occurred after 2 to 3 days of drug administration (metronidazole: -54 ± 25%; metronidazole benzoate: -44 ± 36%). After administration of metronidazole benzoate at 10 mg/kg PO q12h, the reduction in food intake was significantly less pronounced (-24 ± 36%), suggesting that negative effect of metronidazole on food intake in chinchillas is dose-dependent. Variation in metronidazole-induced food intake reduction differed widely between individual chinchillas. CLINICAL SIGNIFICANCE The oral administration of commercial metronidazole and metronidazole benzoate suspensions results in a dose-dependent clinically relevant reduction in food intake in chinchillas. Metronidazole should be used cautiously in this species and food intake should be monitored during treatment. Future studies are needed in order to determine if metronidazole at 10 mg/kg q12h is an effective therapeutic dosage in chinchillas.",2021,At 20 mg/kg PO q12h administration of both commercial suspensions resulted in a significant reduction of food intake.,"['food intake in chinchillas', 'chinchillas']","['metronidazole', 'commercial metronidazole and metronidazole benzoate suspensions', 'metronidazole benzoate', 'Metronidazole', 'metronidazole and metronidazole benzoate suspensions']","['Food intake', 'food intake']","[{'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0008119', 'cui_str': 'Genus Chinchilla'}]","[{'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0353490', 'cui_str': 'Metronidazole benzoate'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}]","[{'cui': 'C0013470', 'cui_str': 'Eating'}]",12.0,0.0476973,At 20 mg/kg PO q12h administration of both commercial suspensions resulted in a significant reduction of food intake.,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mans', 'Affiliation': 'School of Veterinary Medicine, University of Wisconsin-Madison, 2015 Linden Drive, Madison, WI, 53706, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Fink', 'Affiliation': 'School of Veterinary Medicine, University of Wisconsin-Madison, 2015 Linden Drive, Madison, WI, 53706, USA.'}]",The Journal of small animal practice,['10.1111/jsap.13276'] 1557,33260203,The Effectiveness of Dorsal Root Ganglion Neurostimulation for the Treatment of Chronic Pelvic Pain and Chronic Neuropathic Pain of the Lower Extremity: A Comprehensive Review of the Published Data.,"OBJECTIVE To evaluate the effectiveness of dorsal root ganglion neurostimulation for the treatment of refractory, focal pain in the pelvis and lower extremities. DESIGN Systematic review. OUTCOME MEASURES The primary outcome was ≥50% pain relief. Secondary outcomes were physical function, mood, quality of life, opioid usage, and complications. RESULTS One pragmatic randomized controlled trial, four prospective cohort studies, and eight case series met the inclusion criteria. A worst-case scenario analysis from the randomized controlled trial reported ≥50% pain relief in 74% of patients with dorsal root ganglion neurostimulation vs. 51% of patients who experienced at least 50% relief with spinal cord stimulation at 3 months. Cohort data success rates ranged from 43% to 83% at ≤6 months and 27% to 100% at >6 months. Significant improvements were also reported in the secondary outcomes assessed, including mood, quality of life, opioid usage, and health care utilization, though a lack of available quantitative data limits further statistical analysis. Complication rates vary, though the only randomized controlled trial reported a higher rate of adverse events than that seen with traditional neurostimulation. CONCLUSIONS In accordance with the Grades of Recommendation, Assessment, Development, and Evaluation system, low-quality evidence supports dorsal root ganglion neurostimulation as a more effective treatment than traditional neurostimulation for pain and dysfunction associated with complex regional pain syndrome or causalgia. Very low-quality evidence supports dorsal root ganglion neurostimulation for the treatment of chronic pelvic pain, chronic neuropathic groin pain, phantom limb pain, chronic neuropathic pain of the trunk and/or limbs, and diabetic neuropathy.",2021,"Significant improvements were also reported in the secondary outcomes assessed, including mood, quality of life, opioid usage, and health care utilization, though a lack of available quantitative data limits further statistical analysis.",['of the Lower Extremity'],"['Dorsal Root Ganglion Neurostimulation', 'dorsal root ganglion neurostimulation']","['pain relief', 'Complication rates', '≥50% pain relief', 'mood, quality of life, opioid usage, and health care utilization', 'rate of adverse events', 'physical function, mood, quality of life, opioid usage, and complications', 'Chronic Pelvic Pain and Chronic Neuropathic Pain']","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]","[{'cui': 'C0017070', 'cui_str': 'Structure of spinal nerve ganglion'}, {'cui': 'C0521307', 'cui_str': 'Neurostimulation procedure'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C4544057', 'cui_str': 'Chronic neuropathic pain'}]",,0.134085,"Significant improvements were also reported in the secondary outcomes assessed, including mood, quality of life, opioid usage, and health care utilization, though a lack of available quantitative data limits further statistical analysis.","[{'ForeName': 'Ameet', 'Initials': 'A', 'LastName': 'Nagpal', 'Affiliation': 'Department of Anesthesiology, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Clements', 'Affiliation': 'Department of Rehabilitation Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Duszynski', 'Affiliation': 'Spine Intervention Society, Hinsdale, Illinois, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Boies', 'Affiliation': 'Department of Anesthesiology, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa369'] 1558,33267729,Perceptual Learning of Vocoded Speech With and Without Contralateral Hearing: Implications for Cochlear Implant Rehabilitation.,"Purpose An increasing number of individuals with residual or even normal contralateral hearing are being considered for cochlear implantation. It remains unknown whether the presence of contralateral hearing is beneficial or detrimental to their perceptual learning of cochlear implant (CI)-processed speech. The aim of this experiment was to provide a first insight into this question using acoustic simulations of CI processing. Method Sixty normal-hearing listeners took part in an auditory perceptual learning experiment. Each subject was randomly assigned to one of three groups of 20 referred to as NORMAL, LOWPASS, and NOTHING. The experiment consisted of two test phases separated by a training phase. In the test phases, all subjects were tested on recognition of monosyllabic words passed through a six-channel ""PSHC"" vocoder presented to a single ear. In the training phase, which consisted of listening to a 25-min audio book, all subjects were also presented with the same vocoded speech in one ear but the signal they received in their other ear differed across groups. The NORMAL group was presented with the unprocessed speech signal, the LOWPASS group with a low-pass filtered version of the speech signal, and the NOTHING group with no sound at all. Results The improvement in speech scores following training was significantly smaller for the NORMAL than for the LOWPASS and NOTHING groups. Conclusions This study suggests that the presentation of normal speech in the contralateral ear reduces or slows down perceptual learning of vocoded speech but that an unintelligible low-pass filtered contralateral signal does not have this effect. Potential implications for the rehabilitation of CI patients with partial or full contralateral hearing are discussed.",2021,The improvement in speech scores following training was significantly smaller for the NORMAL than for the LOWPASS and NOTHING groups.,"['CI patients with partial or full contralateral hearing', 'Method Sixty normal-hearing listeners took part in an auditory perceptual learning experiment', 'individuals with residual or even normal contralateral hearing']","['Perceptual Learning of Vocoded Speech', 'LOWPASS']",['speech scores'],"[{'cui': 'C0009199', 'cui_str': 'Cochlear prosthesis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0234725', 'cui_str': 'Hearing normal'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0037817', 'cui_str': 'Speech'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.0166966,The improvement in speech scores following training was significantly smaller for the NORMAL than for the LOWPASS and NOTHING groups.,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Chavant', 'Affiliation': ""Aix-Marseille University, Centre National de la Recherche Scientifique, Centrale Marseille, Laboratoire de Mécanique et d'Acoustique, France.""}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Hervais-Adelman', 'Affiliation': 'Department of Psychology - Neurolinguistics, University of Zurich, Switzerland.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Macherey', 'Affiliation': ""Aix-Marseille University, Centre National de la Recherche Scientifique, Centrale Marseille, Laboratoire de Mécanique et d'Acoustique, France.""}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2020_JSLHR-20-00385'] 1559,33043600,"Efficacy and Safety of Guselkumab, an Interleukin-23p19-Specific Monoclonal Antibody, Through One Year in Biologic-Naive Patients With Psoriatic Arthritis.","OBJECTIVE Guselkumab, a human monoclonal antibody specific to interleukin-23p19, demonstrated efficacy and safety versus placebo through week 24 of the phase III DISCOVER-2 trial in biologic-naive patients with psoriatic arthritis (PsA). Here we report 1-year DISCOVER-2 findings. METHODS Adults with active PsA (≥5 swollen and ≥5 tender joints; C-reactive protein level ≥0.6 mg/dl) despite standard nonbiologic treatment were randomized to receive subcutaneous injections of guselkumab 100 mg every 4 weeks, guselkumab 100 mg at week 0, week 4 and every 8 weeks thereafter, or placebo with crossover to guselkumab 100 mg every 4 weeks at week 24. We primarily evaluated clinical efficacy through week 52 by imputing missing data (nonresponse for categorical end points; no change/using multiple imputation for continuous end points). Observed radiographic scores and adverse events (AEs) were summarized. RESULTS Of 739 randomized, treated patients, 93% completed week 52. The proportions of patients in whom a ≥20% improvement from baseline in American College of Rheumatology criteria (ACR20) was achieved were maintained after week 24, reaching 71% (173 of 245) and 75% (185 of 248) for patients randomized to receive treatment every 4 weeks or every 8 weeks, respectively, by week 52. The proportions of patients in whom ACR50/ACR70 and skin responses, minimal or very low disease activity, and dactylitis or enthesitis resolution were achieved at week 24 were also maintained through week 52. Further, low levels of radiographic progression, along with improvements in physical function and health-related quality of life, were sustained through week 52 with continued guselkumab treatment. Few patients experienced serious infections through week 52, with no evidence of a dosing regimen response or increase from weeks 0-24 (4 of 493 [0.8%]) to weeks 24-52 (3 of 493 [0.6%]) among guselkumab-randomized patients. No patient developed an opportunistic infection or died. CONCLUSION In biologic-naive PsA patients, guselkumab provided sustained improvements across diverse manifestations and maintained a favorable risk-benefit profile through week 52.",2021,"OBJECTIVE Guselkumab, a human monoclonal antibody specific to interleukin-23p19, demonstrated efficacy and safety versus placebo through Week24 of the Phase-3 DISCOVER-2 trial in biologic-naïve psoriatic arthritis (PsA) patients.","['Adults with active PsA (≥5 swollen+≥5 tender joints; C-reactive protein ≥0.6mg/dL) despite standard nonbiologic treatment', 'Biologic-naïve Psoriatic Arthritis Patients', 'biologic-naïve psoriatic arthritis (PsA) patients']","['placebo', 'Guselkumab', 'subcutaneous injections of guselkumab 100mg every-4-weeks (Q4W); guselkumab 100mg at Week0, Week4, Q8W; or placebo with crossover to guselkumab 100mg Q4W at Week24']","['radiographic scores and adverse events (AEs', 'ACR50/ACR70 and skin responses, minimal or very low disease activity, and dactylitis or enthesitis resolution', 'ACR criteria (ACR20', 'physical function and health-related quality-of-life', 'opportunistic infection or died']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0240094', 'cui_str': 'Tenderness of joint'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0312646', 'cui_str': 'Finding related to response to skin test'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0239161', 'cui_str': 'Dactylitis'}, {'cui': 'C1282952', 'cui_str': 'Enthesitis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0029118', 'cui_str': 'Opportunistic infectious disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.236911,"OBJECTIVE Guselkumab, a human monoclonal antibody specific to interleukin-23p19, demonstrated efficacy and safety versus placebo through Week24 of the Phase-3 DISCOVER-2 trial in biologic-naïve psoriatic arthritis (PsA) patients.","[{'ForeName': 'Iain B', 'Initials': 'IB', 'LastName': 'McInnes', 'Affiliation': 'University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Proton', 'Initials': 'P', 'LastName': 'Rahman', 'Affiliation': 'Memorial University of Newfoundland, St. Johns, Newfoundland, Canada.'}, {'ForeName': 'Alice B', 'Initials': 'AB', 'LastName': 'Gottlieb', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Hsia', 'Affiliation': 'Janssen Research and Development, LLC, Spring House, Pennsylvania, and University of Pennsylvania Perelman School of Medicine, Philadelphia.'}, {'ForeName': 'Alexa P', 'Initials': 'AP', 'LastName': 'Kollmeier', 'Affiliation': 'Janssen Research and Development, LLC, San Diego, California.'}, {'ForeName': 'Soumya D', 'Initials': 'SD', 'LastName': 'Chakravarty', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, Pennsylvania, and Drexel University College of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Xie L', 'Initials': 'XL', 'LastName': 'Xu', 'Affiliation': 'Janssen Research and Development, LLC, San Diego, California.'}, {'ForeName': 'Ramanand A', 'Initials': 'RA', 'LastName': 'Subramanian', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Prasheen', 'Initials': 'P', 'LastName': 'Agarwal', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Shihong', 'Initials': 'S', 'LastName': 'Sheng', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Yusang', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Cytel, Inc., King of Prussia Pennsylvania.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Zhuang', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, Washington.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41553'] 1560,33040141,Preoperative Acute Pain Is Associated with Postoperative Delirium.,"BACKGROUND Studies have provided some evidence that pain is a risk factor for postoperative delirium (POD). Therefore, we investigated the relationship between preoperative pain and POD after noncardiac surgery. METHODS POD was assessed with the Montreal Cognitive Assessment, and preoperative cognition was assessed with the Mini-Mental State Examination. Plasma C-reactive protein (CRP) was detected by enzyme-linked immunosorbent assay before surgery. Preoperative pain was classified by its duration before surgery as chronic pain (lasting more than 1 month), acute pain (lasting less than 1 month), or no pain (no obvious pain). Multiple linear regression was used to adjust for confounding. RESULTS From October 15, 2018, through August 12, 2019, a total of 67 patients were randomized; 7 were excluded because they were discharged before the seventh postoperative day. The prevalence of POD was significantly higher in the acute pain group (13 of 20; 65%) than in the chronic pain group (5 of 20; 25%) or the no pain group (6 of 20; 30%) (P = 0.019), indicating that delirium is associated with preoperative acute pain. The plasma level of preoperative CRP was also higher in the acute pain group than in the other two groups (mean [interquartile range]: 10.7 [3.3, 29.3] vs 1 [0.5, 3.8]mg/l; P < 0.001), suggesting that elevated preoperative plasma levels of CRP were associated with delirium. CONCLUSIONS Preoperative acute pain was associated with POD, and increased plasma levels of CRP provide a marker. In addition, we found that illiteracy and advanced age were risk factors for POD.",2021,"The prevalence of POD was significantly higher in the acute pain group (13 of 20; 65%) than in the chronic pain group (5 of 20; 25%) or the no pain group (6 of 20; 30%) (P = 0.019), indicating that delirium is associated with preoperative acute pain.","['From October 15, 2018, through August 12, 2019, a total of 67 patients were randomized; 7 were excluded because they were discharged before the seventh postoperative day']",[],"['Montreal Cognitive Assessment, and preoperative cognition', 'prevalence of POD', 'Preoperative pain', 'acute pain', 'Plasma C-reactive protein (CRP', 'plasma level of preoperative CRP']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0303134', 'cui_str': 'Beryllium-7'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",[],"[{'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",67.0,0.258125,"The prevalence of POD was significantly higher in the acute pain group (13 of 20; 65%) than in the chronic pain group (5 of 20; 25%) or the no pain group (6 of 20; 30%) (P = 0.019), indicating that delirium is associated with preoperative acute pain.","[{'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Ding', 'Affiliation': ""Department of Anesthesiology, The Affiliated Hospital of Jiangnan University (Original Department at Wuxi Third People's Hospital), Wuxi, Jiangsu, China.""}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Fujian Maternity and Child Health Hospital, Fuzhou, Fujian, China.'}, {'ForeName': 'Qizhong', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': ""Women and Children's Hospital, School of Medicine, Xiamen University, Xiamen, Fujian, China.""}, {'ForeName': 'Xuliang', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Math and Statistics School of Nanjing Audit University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Department of Anesthesiology, Wuxi People's Hospital of Nanjing Medical University, Wuxi, Jiangsu, China.""}, {'ForeName': 'Guowei', 'Initials': 'G', 'LastName': 'Qin', 'Affiliation': ""Department of Anesthesiology, Wuxi People's Hospital of Nanjing Medical University, Wuxi, Jiangsu, China.""}, {'ForeName': 'Shunmei', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': ""Department of Anesthesiology, Wuxi People's Hospital of Nanjing Medical University, Wuxi, Jiangsu, China.""}, {'ForeName': 'Dongxiao', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': ""The Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi, Jiangsu, China.""}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa314'] 1561,33040755,Alcohol-impregnated caps and ambulatory central-line-associated bloodstream infections (CLABSIs): A randomized clinical trial.,"OBJECTIVE To evaluate the effect of 70% isopropyl alcohol-impregnated central venous catheter caps on ambulatory central-line-associated bloodstream infections (CLABSIs) in pediatric hematology-oncology patients. DESIGN This study was a 24-month, cluster-randomized, 2 period, crossover clinical trial. SETTING The study was conducted in 15 pediatric healthcare institutions, including 16 pediatric hematology-oncology clinics. PARTICIPANTS All patients with an external central line followed at 1 of the 16 hematology-oncology clinics. INTERVENTION Usual ambulatory central-line care per each institution using 70% isopropyl alcohol-impregnated caps at home compared to usual ambulatory central-line care in each institution without using 70% isopropyl alcohol-impregnated caps. RESULTS Of the 16 participating clinics, 15 clinics completed both assignment periods. As assigned, there was no reduction in CLABSI incidence in clinics using 70% isopropyl alcohol-impregnated caps (1.23 per 1,000 days) compared with standard practices (1.38 per 1,000 days; adjusted incidence rate ratio [aIRR], 0.83; 95% CI, 0.63-1.11). In the per-protocol population, there was a reduction in positive blood culture incidence in clinics using 70% isopropyl alcohol-impregnated caps (1.51 per 1,000 days) compared with standard practices (1.88 per 1,000 days; aIRR, 0.72; 95% CI, 0.52-0.99). No adverse events were reported. CONCLUSIONS Isopropyl alcohol-impregnated central-line caps did not lead to a statistically significant reduction in CLABSI rates in ambulatory hematology-oncology patients. In the per-protocol analysis, there was a statistically significant decrease in positive blood cultures. Larger trials are needed to elucidate the impact of 70% isopropyl alcohol-impregnated caps in the ambulatory setting. REGISTRATION ClinicalTrials.gov; NCT02351258.",2021,"CONCLUSIONS Isopropyl alcohol-impregnated central-line caps did not lead to a statistically significant reduction in CLABSI rates in ambulatory hematology-oncology patients.","['All patients with an external central line followed at 1 of the 16 hematology-oncology clinics', '16 participating clinics', 'ambulatory hematology-oncology patients', 'pediatric hematology-oncology patients', '15 pediatric healthcare institutions, including 16 pediatric hematology-oncology clinics']","['Usual ambulatory central-line care per each institution using 70% isopropyl alcohol-impregnated caps at home compared to usual ambulatory central-line care in each institution without using 70% isopropyl alcohol-impregnated caps', '70% isopropyl alcohol-impregnated central venous catheter caps', 'Alcohol-impregnated caps and ambulatory central-line-associated bloodstream infections (CLABSIs', 'Isopropyl alcohol-impregnated central-line caps', 'isopropyl alcohol-impregnated caps']","['CLABSI incidence', 'adverse events', 'positive blood cultures', 'CLABSI rates', 'positive blood culture incidence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C1145640', 'cui_str': 'Central venous catheter'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C3839015', 'cui_str': 'Oncology clinic'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1518927', 'cui_str': 'Pediatric hematology oncology'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1279810', 'cui_str': 'Care of central line'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0022237', 'cui_str': 'Isopropyl Alcohol'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1145640', 'cui_str': 'Central venous catheter'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C3161235', 'cui_str': 'CLABSI - central line associated bloodstream infection'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0740299', 'cui_str': 'Blood culture positive for microorganism'}]",15.0,0.0760498,"CONCLUSIONS Isopropyl alcohol-impregnated central-line caps did not lead to a statistically significant reduction in CLABSI rates in ambulatory hematology-oncology patients.","[{'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Milstone', 'Affiliation': 'Department of Pediatrics, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Rosenberg', 'Affiliation': 'Department of Pediatrics, Division of Quality and Safety, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Gayane', 'Initials': 'G', 'LastName': 'Yenokyan', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Danielle W', 'Initials': 'DW', 'LastName': 'Koontz', 'Affiliation': 'Department of Pediatrics, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Marlene R', 'Initials': 'MR', 'LastName': 'Miller', 'Affiliation': 'Department of Pediatrics, Division of Quality and Safety, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Infection control and hospital epidemiology,['10.1017/ice.2020.467'] 1562,33051045,Skin toxicity following radiotherapy in patients with breast carcinoma: is anthocyanin supplementation beneficial?,"BACKGROUND The EU-supported ATHENA project stems from a previous study suggesting that moderate wine consumption reduced the side-effects of radiotherapy (RT) in breast cancer patients, an effect possibly due to non-alcoholic anthocyanin fractions of wine. OBJECTIVE To evaluate the role of anthocyanins on RT skin side effects in breast cancer patients. METHODS Randomized, controlled, double-blind clinical trial. Patients were assigned to an intensity modulated radiation therapy (IMRT) either for three or five weeks, then randomized to receive three times a day a water-soluble anthocyanin (125 mg)-rich extract of corn cob or a placebo. Supplementation started one week before till the end of RT. Skin characteristics were detected by a standardized, non-invasive Cutometer® dual-MPA580, providing quantitative indices of skin maximal distensibility (R0), elasticity (R2, R5, R7) and viscoelasticity (R6); a Mexameter® MX18 probe evaluated the skin erythema (Er) and melanin (M). Measures were performed before (T0), at the end of RT and of supplementation (T1), and 1, 6 and 12 months after RT (T2-T4). Acute and late skin toxicity were scored according to the RTOG/EORTG scale. Selected biomarkers were measured at T0 and T1. RESULTS 193 patients previously assigned to 3- or 5-week RT schedules were randomized to either anthocyanin (97) or placebo (96) supplementation. RT induced changes in skin parameters: R0, R2, R5 and R7 decreased, while R6 increased; the changes in R0 and R6 continued in the same direction up to one year, while the others recovered towards basal values; Er and M peaked at T1 and T2, respectively, and returned to basal values at T4. Comparable skin changes were apparent in anthocyanin and placebo groups. A moderate RT-induced increase in total and HDL cholesterol and triglycerides was prevented by anthocyanins. CONCLUSIONS Anthocyanin supplementation did not prevent RT-induced local skin toxicity. The supplementation was well tolerated and safe.",2021,"RT induced changes in skin parameters: R0, R2, R5 and R7 decreased, while R6 increased; the changes in R0 and R6 continued in the same direction up to one year, while the others recovered towards basal values; Er and M peaked at T1 and T2, respectively, and returned to basal values at T4.","['patients with breast carcinoma', 'breast cancer patients', '193 patients previously assigned to 3- or 5-week RT schedules']","['anthocyanins', 'water-soluble anthocyanin ', 'radiotherapy (RT', 'anthocyanin', '125\xa0mg)-rich extract of corn cob or a placebo', 'placebo (96) supplementation', 'radiotherapy', 'intensity modulated radiation therapy (IMRT', 'Anthocyanin supplementation']","['skin maximal distensibility (R0), elasticity (R2, R5, R7) and viscoelasticity (R6); a Mexameter® MX18 probe evaluated the skin erythema (Er) and melanin (M', 'skin parameters: R0, R2, R5 and R7', 'Acute and late skin toxicity', 'Skin toxicity', 'RT-induced local skin toxicity', 'tolerated and safe', 'total and HDL cholesterol and triglycerides', 'Skin characteristics']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0678222', 'cui_str': 'Carcinoma of breast'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C3667867', 'cui_str': 'corn cob extract'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C1512814', 'cui_str': 'Intensity modulated radiation therapy'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0025196', 'cui_str': 'Melanin'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",193.0,0.139495,"RT induced changes in skin parameters: R0, R2, R5 and R7 decreased, while R6 increased; the changes in R0 and R6 continued in the same direction up to one year, while the others recovered towards basal values; Er and M peaked at T1 and T2, respectively, and returned to basal values at T4.","[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Bracone', 'Affiliation': 'Department of Epidemiology and Prevention, IRCCS Neuromed, Pozzilli, IS, Italy.'}, {'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'De Curtis', 'Affiliation': 'Department of Epidemiology and Prevention, IRCCS Neuromed, Pozzilli, IS, Italy.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Di Castelnuovo', 'Affiliation': 'Mediterranea Cardiocentro, Napoli, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Pilu', 'Affiliation': 'Department of Agricultural and Environmental Sciences - Production, Landscape, Agroenergy, Università degli Studi di Milano, Milano, Italy.'}, {'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Boccardi', 'Affiliation': 'Radiotherapy Unit, Gemelli Molise Hospital Campobasso, Italy.'}, {'ForeName': 'Savino', 'Initials': 'S', 'LastName': 'Cilla', 'Affiliation': 'Medical Physics Unit, Gemelli Molise Hospital Campobasso, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Macchia', 'Affiliation': 'Radiotherapy Unit, Gemelli Molise Hospital Campobasso, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Deodato', 'Affiliation': 'Radiotherapy Unit, Gemelli Molise Hospital Campobasso, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Costanzo', 'Affiliation': 'Department of Epidemiology and Prevention, IRCCS Neuromed, Pozzilli, IS, Italy.'}, {'ForeName': 'Licia', 'Initials': 'L', 'LastName': 'Iacoviello', 'Affiliation': 'Department of Epidemiology and Prevention, IRCCS Neuromed, Pozzilli, IS, Italy; Department of Medicine and Surgery, Research Center in Epidemiology and Preventive Medicine (EPIMED), University of Insubria, Varese, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'de Gaetano', 'Affiliation': 'Department of Epidemiology and Prevention, IRCCS Neuromed, Pozzilli, IS, Italy.'}, {'ForeName': 'Alessio Giuseppe', 'Initials': 'AG', 'LastName': 'Morganti', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine (DIMES), University of Bologna, Bologna, Italy.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Petroni', 'Affiliation': 'Department of Bioscience, Università degli Studi di Milano, Milano, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Tonelli', 'Affiliation': 'Department of Bioscience, Università degli Studi di Milano, Milano, Italy.'}, {'ForeName': 'Maria Benedetta', 'Initials': 'MB', 'LastName': 'Donati', 'Affiliation': 'Department of Epidemiology and Prevention, IRCCS Neuromed, Pozzilli, IS, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cerletti', 'Affiliation': 'Department of Epidemiology and Prevention, IRCCS Neuromed, Pozzilli, IS, Italy. Electronic address: chiara.cerletti@neuromed.it.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.09.030'] 1563,33049119,Randomized pilot trial of ipratropium versus placebo in children with critical asthma.,"OBJECTIVE To test the effects of inhaled ipratropium on clinical outcomes of critical asthma in the first randomized trial of this adjunctive therapy in critically ill children. DESIGN Pilot, placebo-controlled, double-blinded, and randomized-controlled trial PATIENTS: Thirty children (15 per group) with critical asthma receiving high-intensity albuterol per a standardized pathway utilizing objective assessments to wean patients to less frequent albuterol administration. INTERVENTIONS Subjects were randomized to receive either nebulized ipratropium bromide (500 µg in 0.9% saline per dose) or an equivalent volume of nebulized 0.9% saline every 6 h until the patient was successfully weaned to albuterol doses every 2 h (""q2 albuterol""). MEASUREMENTS AND MAIN RESULTS Demographics, initial clinical severity score, and asthma histories were similar between groups. There was no significant difference in the median duration of high-intensity albuterol between the treatment group (17.5 [10.3-22.1] h) and placebo group (14.6 [12.7-24.5] days; p = .56). Similarly, there was no significant difference in pediatric intensive care unit length of stay (22.6 [21.1-33.6] vs. 21.4 [16.1-35.8] h; p = .74) or hospital length of stay (48.0 [41.8-59.8] vs. 47.3 [37.2-63.1] h; p = .67). In multivariate linear regression adjusting for identified confounders, treatment with ipratropium was not significantly associated with any of the three outcomes. Side effects were rare and occurred with equally between both groups CONCLUSIONS: Adjunctive therapy with ipratropium was not associated with decreased duration of high-intensity albuterol or shortened length of stay when compared to placebo. A larger, multicenter trial is warranted to confirm that ipratropium does not improve clinical outcomes.",2020,Adjunctive therapy with ipratropium was not associated with decreased duration of high intensity albuterol or shortened length of stay when compared to placebo.,"['critically ill children', 'Thirty children (15/group) with critical asthma receiving high-intensity albuterol per a standardized pathway utilizing objective assessments to wean patients to less frequent albuterol administration', 'Children with Critical Asthma']","['nebulized ipratropium bromide (500µg in 0.9% saline per dose) or an equivalent volume of nebulized 0.9% saline', 'placebo', 'ipratropium', 'Ipratropium', 'inhaled ipratropium', 'Placebo']","['median duration of high intensity albuterol', 'PICU length of stay', 'duration of high intensity albuterol or shortened length of stay', 'hospital length of stay', 'Demographics, initial clinical severity score, and asthma histories']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0700580', 'cui_str': 'ipratropium bromide'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027235', 'cui_str': 'Ipratropium'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0019664', 'cui_str': 'History'}]",,0.615042,Adjunctive therapy with ipratropium was not associated with decreased duration of high intensity albuterol or shortened length of stay when compared to placebo.,"[{'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Murphy', 'Affiliation': ""Division of Pediatric Critical Care Medicine, Rainbow Babies and Children's Hospital, Cleveland, Ohio, USA.""}, {'ForeName': 'Nabihah', 'Initials': 'N', 'LastName': 'Mahmood', 'Affiliation': ""Division of Pediatric Critical Care Medicine, Rainbow Babies and Children's Hospital, Cleveland, Ohio, USA.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Craven', 'Affiliation': ""Division of Pediatric Pulmonology, Rainbow Babies and Children's Hospital, Cleveland, Ohio, USA.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gallagher', 'Affiliation': ""Department of Respiratory Care, Rainbow Babies and Children's Hospital, Cleveland, Ohio, USA.""}, {'ForeName': 'Kristie', 'Initials': 'K', 'LastName': 'Ross', 'Affiliation': ""Division of Pediatric Pulmonology, Rainbow Babies and Children's Hospital, Cleveland, Ohio, USA.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Speicher', 'Affiliation': ""Division of Pediatric Critical Care Medicine, Rainbow Babies and Children's Hospital, Cleveland, Ohio, USA.""}, {'ForeName': 'Alexandre T', 'Initials': 'AT', 'LastName': 'Rotta', 'Affiliation': ""Division of Pediatric Critical Care Medicine, Rainbow Babies and Children's Hospital, Cleveland, Ohio, USA.""}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Shein', 'Affiliation': ""Division of Pediatric Critical Care Medicine, Rainbow Babies and Children's Hospital, Cleveland, Ohio, USA.""}]",Pediatric pulmonology,['10.1002/ppul.25115'] 1564,33063323,Lost in translation: true clinical impact of reflectance confocal microscopy overlooked in 'Biopsy outperforms reflectance confocal microscopy in diagnosing and subtyping basal cell carcinoma: results and experiences from a randomized controlled multicentre trial': reply from authors.,,2021,"We agree on the importance to determine the place of reflectance confocal microscopy (RCM) as a diagnostic tool in real-world clinical practice, which is why we originally initiated our study.","['1,2', 'patients with clinically suspected primary basal cell carcinoma (BCC']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0007117', 'cui_str': 'Basal cell carcinoma'}, {'cui': 'C4721806', 'cui_str': 'Basal cell carcinoma of skin'}]",[],[],,0.0346012,"We agree on the importance to determine the place of reflectance confocal microscopy (RCM) as a diagnostic tool in real-world clinical practice, which is why we originally initiated our study.","[{'ForeName': 'W', 'Initials': 'W', 'LastName': 'Woliner-van der Weg', 'Affiliation': 'Department of Dermatology, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Peppelman', 'Affiliation': 'Department of Dermatology, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'P E J', 'Initials': 'PEJ', 'LastName': 'van Erp', 'Affiliation': 'Department of Dermatology, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'S F K', 'Initials': 'SFK', 'LastName': 'Lubeek', 'Affiliation': 'Department of Dermatology, Radboud University Medical Centre, Nijmegen, the Netherlands.'}]",The British journal of dermatology,['10.1111/bjd.19605'] 1565,33063439,Ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a secondary analysis of the PITCHES trial.,"OBJECTIVE To evaluate whether a particular group of women with intrahepatic cholestasis of pregnancy (ICP), based on their presenting characteristics, would benefit from treatment with ursodeoxycholic acid (UDCA). DESIGN Secondary analysis of the PITCHES trial (ISRCTN91918806). SETTING United Kingdom. POPULATION OR SAMPLE 527 women with ICP. METHODS Subgroup analyses were performed to determine whether baseline bile acid concentrations or baseline itch scores moderated a woman's response to treatment with UDCA. MAIN OUTCOME MEASURES Bile acid concentration and itch score. RESULTS In women with baseline bile acid concentrations less than 40 μmol/l, treatment with UDCA resulted in increased post-randomisation bile acid concentrations (geometric mean ratio 1.19, 95% CI 1.00-1.41, P = 0.048). A test of interaction showed no significance (P = 0.647). A small, clinically insignificant difference was seen in itch response in women with a high baseline itch score (-6.0 mm, 95% CI -11.80 to -0.21, P = 0.042), with a test of interaction not showing significance (P = 0.640). Further subgroup analyses showed no significance. Across all women there was a weak relationship between bile acid concentrations and itch severity. CONCLUSIONS There was no subgroup of women with ICP in whom a beneficial effect of treatment with UDCA on bile acid concentration or itch score could be identified. This confirms that its routine use in women with this condition for improvement of bile acid concentration or itch score should be reconsidered. TWEETABLE ABSTRACT PITCHES: No group of women with ICP has been found in whom UDCA reduces bile acid concentrations or pruritus.",2021,"In women with baseline bile acid concentrations less than 40 μmol/L, treatment with UDCA resulted in increased post-randomisation bile acid concentrations (geometric mean ratio 1.19, 95% CI 1.00 to 1.41, p = 0.048).","['527 women with ICP', 'women with intrahepatic cholestasis of pregnancy (ICP', 'intrahepatic cholestasis of pregnancy', 'United Kingdom']","['ursodeoxycholic acid (UDCA', 'Ursodeoxycholic acid', 'UDCA']","['itch response', 'bile acid concentration or itch score', 'Bile acid concentration and itch score', 'bile acid concentrations and itch severity', 'post-randomisation bile acid concentrations']","[{'cui': 'C4517805', 'cui_str': '527'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0268318', 'cui_str': 'Cholestasis of pregnancy'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}]","[{'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}]","[{'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0687676', 'cui_str': 'After values'}]",527.0,0.470972,"In women with baseline bile acid concentrations less than 40 μmol/L, treatment with UDCA resulted in increased post-randomisation bile acid concentrations (geometric mean ratio 1.19, 95% CI 1.00 to 1.41, p = 0.048).","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Fleminger', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'P T', 'Initials': 'PT', 'LastName': 'Seed', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Juszczak', 'Affiliation': 'National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'P H', 'Initials': 'PH', 'LastName': 'Dixon', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Chambers', 'Affiliation': 'ICP Support, Sutton Coldfield, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dorling', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, IWK Health Centre, Halifax, NS, Canada.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Williamson', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Thornton', 'Affiliation': 'Division of Child Health, Obstetrics and Gynaecology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Chappell', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16567'] 1566,33064290,Improving health-related quality of life and adherence to health-promoting behaviors among coronary artery bypass graft patients: a non-randomized controlled trial study.,"PURPOSE This study aimed to determine the impact of a healthy lifestyle empowerment program on health-related quality of life and adherence to health-promoting behaviors in coronary artery bypass graft patients. METHODS This non-randomized controlled trial was conducted in 2019 on 97 coronary artery bypass graft patients in Iran. Participants were selected by culturally pragmatic and non-randomized method and assigned to healthy lifestyle empowerment program group (HLEPG) (n = 49) and conventional education group (CEG) (n = 48). Data were collected by the 12-item short-form health survey (SF-12) and health-promoting lifestyle profile II (HPLP2), which were administered at baseline and three-month follow-up. The healthy lifestyle empowerment program and conventional education as two interventions were performed for HLEPG and CEG, respectively. Data analysis was performed using the paired t-test, independent t-test, analysis of covariance and linear mixed method at the 0.05 significance level. RESULTS In the follow-up, both groups showed a significant increase in the mean score of health-related quality of life (p ≤ 0.001) but this increase was visibly greater in the HLEPG (from 23.47 ± 7.48 to 35.60 ± 5.95) than in the CEG (from 22.93 ± 5.93 to 27.6 ± 4.90). The healthy lifestyle empowerment program also significantly increased the mean score of adherence to health-promoting behaviors in the HLEPG (p ≤ 0.001), whereas no such change was observed in the CEG. The results of the linear mixed model showed that the follow-up scores health-related quality of life and adherence to health-promoting behaviors of the HLEPG were 27.26 and 7.56 units significantly greater than the CEG after HLEP, respectively (p < 0.001). CONCLUSION Considering the results of this study, health care providers are recommended to devise and implement healthy lifestyle empowerment programs to improve the health-related quality of life of coronary artery bypass surgery patients. CLINICAL TRIAL REGISTRATION Registered at Iranian Registry of Clinical Trials (IRCT20171213037860N1).",2021,"In the follow-up, both groups showed a significant increase in the mean score of health-related quality of life (p ≤ 0.001) but this increase was visibly greater in the HLEPG (from 23.47 ± 7.48 to 35.60 ± 5.95) than in the CEG (from 22.93 ± 5.93 to 27.6 ± 4.90).","['coronary artery bypass surgery patients', '2019 on 97 coronary artery bypass graft patients in Iran', 'coronary artery bypass graft patients']","['HLEPG', 'healthy lifestyle empowerment program', 'healthy lifestyle empowerment program group (HLEPG) (n\u2009=\u200949) and conventional education group (CEG']","['mean score of health-related quality of life', '12-item short-form health survey (SF-12) and health-promoting lifestyle profile II (HPLP2', 'mean score of adherence to health-promoting behaviors', 'Improving health-related quality of life and adherence to health-promoting behaviors', 'health-related quality of life and adherence to health-promoting behaviors', 'scores health-related quality of life and adherence to health-promoting behaviors of the HLEPG']","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0150375', 'cui_str': 'Group education'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0517496', 'cui_str': 'Health promotion behavior'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",,0.0846604,"In the follow-up, both groups showed a significant increase in the mean score of health-related quality of life (p ≤ 0.001) but this increase was visibly greater in the HLEPG (from 23.47 ± 7.48 to 35.60 ± 5.95) than in the CEG (from 22.93 ± 5.93 to 27.6 ± 4.90).","[{'ForeName': 'Shabnam', 'Initials': 'S', 'LastName': 'Zafari Nobari', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Vali Asr Ave., Niayesh Cross Road, Tehran, Iran.'}, {'ForeName': 'Parvaneh', 'Initials': 'P', 'LastName': 'Vasli', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Vali Asr Ave., Niayesh Cross Road, Tehran, Iran. p-vasli@sbmu.ac.ir.'}, {'ForeName': 'Meimanat', 'Initials': 'M', 'LastName': 'Hosseini', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Vali Asr Ave., Niayesh Cross Road, Tehran, Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Nasiri', 'Affiliation': 'Department of Basic Sciences, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-020-02675-3'] 1567,33055576,Keeping Each Other Accountable: Social Strategies for Smoking Cessation and Healthy Living in Vietnamese American Men.,"Vietnamese American males have high smoking rates. This study explored social support mechanisms provided by lay health workers (LHWs) and family members through a smoking cessation intervention. Eight focus groups (N = 54) were conducted in Vietnamese stratified by intervention arms (Tobacco [experimental] and healthy living [control]) with 18 smokers, 18 family members, and 18 LHWs. Smokers reported feeling more accountable for their health behaviors, and smoking changes were reinforced by family members, peers, and LHWs through conversations facilitated during and outside the program. Culturally appropriate interventions with multiple social support mechanisms may reduce smoking in minority populations.",2020,This study explored social support mechanisms provided by lay health workers (LHWs) and family members through a smoking cessation intervention.,"['lay health workers (LHWs) and family members through a smoking cessation intervention', 'Vietnamese American Men', 'Vietnamese American males']",['Vietnamese stratified by intervention arms (Tobacco [experimental] and healthy living [control'],[],"[{'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C1692317', 'cui_str': 'Smoking cessation assistance'}, {'cui': 'C4505363', 'cui_str': 'Vietnamese Americans'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],54.0,0.00986097,This study explored social support mechanisms provided by lay health workers (LHWs) and family members through a smoking cessation intervention.,"[{'ForeName': 'Jazmine D', 'Initials': 'JD', 'LastName': 'Kenny', 'Affiliation': 'Public Health, University of California, Merced (Drs Kenny and Burke); and Psychiatry, University of California San Francisco, San Francisco (Drs Tsoh, Nguyen, and Le).'}, {'ForeName': 'Janice Y', 'Initials': 'JY', 'LastName': 'Tsoh', 'Affiliation': ''}, {'ForeName': 'Bang H', 'Initials': 'BH', 'LastName': 'Nguyen', 'Affiliation': ''}, {'ForeName': 'Khanh', 'Initials': 'K', 'LastName': 'Le', 'Affiliation': ''}, {'ForeName': 'Nancy J', 'Initials': 'NJ', 'LastName': 'Burke', 'Affiliation': ''}]",Family & community health,['10.1097/FCH.0000000000000270'] 1568,33059467,Exploration of the characteristics of chronotypes in upper gastrointestinal tract diseases: a multicenter study in Japan.,"Characteristics of the chronotypes of patients with gastrointestinal disease are unknown. We evaluated chronotypes of patients with upper gastrointestinal diseases with the Munich ChronoType Questionnaire (MCTQ). A total of 2027 subjects from 29 institutions in Japan who had undergone esophagogastroduodenoscopy were asked to answer the MCTQ. The subjects' chronotypes were divided into three groups (early, intermediate, and late chronotype) using the sleep-corrected mid-point of sleep on free days (MSF SC ) values. According to their endoscopic diagnosis and abdominal symptoms, the subjects were divided into the reflux esophagitis (RE) group, gastroduodenal ulcer (GDU) group, upper gastrointestinal carcinoma (CA) group, functional dyspepsia (FD) group, non-FD group, and control group. In total, 1128 subjects were eligible for the analysis. The MSF SC (average ± standard deviation, clock hours, h) of each disease group was as follows: control group: 02.51 ± 1.22, non-FD group: 02.69 ± 1.14, FD group: 02.91 ± 1.19, RE group: 02.58 ± 1.05, GDU group: 02.47 ± 1.31, and CA group: 02.11 ± 1.08 h. Compared to the control group, the rate of late chronotype of the FD group significantly increased to 33.3%, whereas that of early chronotype of the CA group significantly increased to 38.3% ( P = .0177 and 0.0036, respectively). In both the FD and CA groups, chronotype was the independent factor related to the diseases. The adjusted odds ratio of late chronotype to early chronotype was 3.01 [95% CI, 1.23-7.35] in the FD group and 0.44 [95% CI, 0.23-0.85] in the CA group. In conclusion, late chronotype was common in patients with FD, and early chronotype was common in patients with upper gastrointestinal carcinoma.",2021,"Compared to the control group, the rate of late chronotype of the FD group significantly increased to 33.3%, whereas that of early chronotype of the CA group significantly increased to 38.3% ( P = .0177 and 0.0036, respectively).","['upper gastrointestinal tract diseases', 'patients with gastrointestinal disease', 'patients with upper gastrointestinal diseases with the Munich ChronoType Questionnaire (MCTQ', '1128 subjects were eligible for the analysis', 'subjects were divided into the reflux esophagitis (RE) group, gastroduodenal ulcer (GDU) group, upper gastrointestinal carcinoma (CA) group, functional dyspepsia (FD) group, non-FD group, and control group', '2027 subjects from 29 institutions in Japan who had undergone esophagogastroduodenoscopy']",['MCTQ'],"['rate of late chronotype', 'adjusted odds ratio of late chronotype to early chronotype']","[{'cui': 'C3203348', 'cui_str': 'Upper gastrointestinal tract structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017178', 'cui_str': 'Disorder of gastrointestinal tract'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0014869', 'cui_str': 'Esophagitis, Reflux'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030920', 'cui_str': 'Peptic ulcer'}, {'cui': 'C0007097', 'cui_str': 'Carcinoma'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0205300', 'cui_str': 'Non-functional'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",2027.0,0.0171479,"Compared to the control group, the rate of late chronotype of the FD group significantly increased to 33.3%, whereas that of early chronotype of the CA group significantly increased to 38.3% ( P = .0177 and 0.0036, respectively).","[{'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Kiyotoki', 'Affiliation': 'Faculty of Laboratory Science, Yamaguchi University Graduate School of Medicine, Ube, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Nishikawa', 'Affiliation': 'Department of Gastroenterology, Shuto General Hospital, Yanai, Japan.'}, {'ForeName': 'Naoyoshi', 'Initials': 'N', 'LastName': 'Nagata', 'Affiliation': 'Department of Gastroenterological Endoscopy, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Niikura', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, the University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Doyama', 'Affiliation': 'Department of Gastroenterology, Ishikawa Prefectural Central Hospital, Kanazawa, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Imagawa', 'Affiliation': 'Imagawa Medical Clinic, Kasada, Mitoyo, Japan.'}, {'ForeName': 'Kenkei', 'Initials': 'K', 'LastName': 'Hasatani', 'Affiliation': 'Department of Gastroenterology, Fukui Prefectural Hospital, Fukui, Japan.'}, {'ForeName': 'Waku', 'Initials': 'W', 'LastName': 'Hatta', 'Affiliation': 'Division of Gastroenterology, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Sumiyoshi', 'Affiliation': 'Department of Gastroenterology, Tonan Hospital, Chuo-ku, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Nebiki', 'Affiliation': 'Department of Gastroenterology, Osaka City General Hospital, Osaka, Japan.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Nagami', 'Affiliation': 'Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Nishida', 'Affiliation': 'Department of Gastroenterology, Toyonaka Municipal Hospital, Toyonaka, Japan.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Kakushima', 'Affiliation': 'Division of Endoscopy, Shizuoka Cancer Center, Suntougun, Japan.'}, {'ForeName': 'Mikitaka', 'Initials': 'M', 'LastName': 'Iguchi', 'Affiliation': 'Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Hideomi', 'Initials': 'H', 'LastName': 'Tomida', 'Affiliation': 'Department of Gastroenterology, Ehime Prefectural Central Hospital, Matsuyama, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Department of Gastroenterology and Hepatology, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Shiko', 'Initials': 'S', 'LastName': 'Kuribayashi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Gunma University Hospital, Maebashi, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Narasaka', 'Affiliation': 'Department of Gastroenterology, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Takuto', 'Initials': 'T', 'LastName': 'Hikichi', 'Affiliation': 'Department of Endoscopy, Fukushima Medical University Hospital, Fukushima, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Yada', 'Affiliation': 'Department of Gastroenterology & Hepatology, Kohnodai Hospital, National Center for Global Health and Medicine, Ichikawa, Japan.'}, {'ForeName': 'Yorinari', 'Initials': 'Y', 'LastName': 'Ochiai', 'Affiliation': 'Department of Gastroenterology, Toranomon Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Furuhashi', 'Affiliation': 'Department of Endoscopy, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Yoshio', 'Affiliation': 'Department of Gastroenterology, Cancer Institute Hospital, Tokyo, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Mori', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization Tokyo Medical Center, Tokyo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Yamauchi', 'Affiliation': 'Department of Gastroenterology, Mitoyo General Hospital, Kannonji, Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Kitamura', 'Affiliation': 'Department of Gastroenterology, Kanazawa University Hospital, Kanazawa, Japan.'}, {'ForeName': 'Tomoki', 'Initials': 'T', 'LastName': 'Fujita', 'Affiliation': 'Department of Medical Gastroenterology, Otaru-Ekisaikai Hospital, Otaru, Japan.'}, {'ForeName': 'Katsuhiro', 'Initials': 'K', 'LastName': 'Mabe', 'Affiliation': 'Junpukai Health Maintenance Center Kurashiki, Kurashiki, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Mikami', 'Affiliation': 'Division of Endoscopy, Hirosaki University Hospital, Hirosaki, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Goto', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine, Ube, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Akashi', 'Affiliation': 'The Research Institute for Time Studies, Yamaguchi University, Yamaguchi, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Hamamoto', 'Affiliation': 'Department of Information Science and Engineering, Yamaguchi University Graduate School of Sciences and Technology for Innovation, Ube, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Fujishiro', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Sakaida', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine, Ube, Japan.'}]",Chronobiology international,['10.1080/07420528.2020.1830791'] 1569,33054533,"Optical coherence tomography outcomes from SPRINT-MS, a multicenter, randomized, double-blind trial of ibudilast in progressive multiple sclerosis.","BACKGROUND The SPRINT-MS trial demonstrated benefit of ibudilast on brain atrophy over 96 weeks in progressive multiple sclerosis (MS). Optical coherence tomography (OCT) was performed in all trial participants. OBJECTIVE Report the OCT results of the SPRINT-MS trial. METHODS OCT was obtained at baseline and every 6 months using spectral domain OCT and analyzed by an OCT reading center. Change in each OCT outcome measure by treatment group was estimated using linear mixed models. RESULTS Change in pRNFL thickness was +0.0424 uM/year (95% confidence interval (CI): -0.3091 to 0.3939) for ibudilast versus -0.2630 uM (95% CI: -0.5973 to 0.0714) for placebo ( n  = 244, p  = 0.22). Macular volume change was -0.00503 mm 3 /year (-0.02693 to 0.01688) with ibudilast versus -0.03659 mm 3 /year (-0.05824 to -0.01494) for placebo in the Spectralis cohort ( n  = 61, p  = 0.044). For the Cirrus cohort, macular volume change was -0.00040 mm 3 /year (-0.02167, 0.020866) with ibudilast compared to -0.02083 mm 3 /year (-0.04134 to -0.00033) for placebo ( n  = 183, p  = 0.1734). Ganglion cell-inner plexiform layer thickness change, available from Cirrus, was -0.4893 uM/year (-0.9132, -0.0654) with ibudilast versus -0.9587 uM/year (-1.3677, -0.5498) with placebo ( n  = 183, p  = 0.12). CONCLUSION Retinal thinning in MS may be attenuated by ibudilast. Sample size estimates suggest OCT can be a viable outcome measure in progressive MS trials if a therapy has a large treatment effect. TRIAL REGISTRATION NN102/SPRINT-MS ClinicalTrials.gov number, NCT01982942.",2020,Macular volume change was -0.00503 mm 3 /year,['progressive multiple sclerosis'],"['Optical coherence tomography (OCT', 'placebo']","['Macular volume change', 'pRNFL thickness', 'Ganglion cell-inner plexiform layer thickness change']","[{'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}]","[{'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0035316', 'cui_str': 'Retinal Ganglion Cells'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0450207', 'cui_str': 'Plexiform'}]",,0.511881,Macular volume change was -0.00503 mm 3 /year,"[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Bermel', 'Affiliation': 'Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Janel K', 'Initials': 'JK', 'LastName': 'Fedler', 'Affiliation': 'Data Coordinating Center, Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT), University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kaiser', 'Affiliation': 'Cole Eye Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Novalis', 'Affiliation': 'Digital Angiography Reading Center, Great Neck, NY, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Schneebaum', 'Affiliation': 'Digital Angiography Reading Center, Great Neck, NY, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Klingner', 'Affiliation': 'Data Coordinating Center, Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT), University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Williams', 'Affiliation': 'Digital Angiography Reading Center, Great Neck, NY, USA.'}, {'ForeName': 'Jon W', 'Initials': 'JW', 'LastName': 'Yankey', 'Affiliation': 'Data Coordinating Center, Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT), University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Dixie J', 'Initials': 'DJ', 'LastName': 'Ecklund', 'Affiliation': 'Data Coordinating Center, Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT), University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Chase', 'Affiliation': 'Clinical Coordinating Center, Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT), Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Naismith', 'Affiliation': 'Department of Neurology, Washington University, St. Louis, MI, USA.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Klawiter', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Goodman', 'Affiliation': 'Department of Neurology, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Coffey', 'Affiliation': 'Data Coordinating Center, Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT), University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Fox', 'Affiliation': 'Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, OH, USA.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458520964409'] 1570,33261032,The Effect of Acute Caffeine Ingestion on Cognitive Dual Task Performance during Assessment of Static and Dynamic Balance in Older Adults.,"The present work aimed to evaluate the effect of 3 mg·kg -1 caffeine consumption on the standing and dynamic balance performance of older adults and sought to establish if caffeine ingestion can modulate the influence of a cognitive dual task on balance performance. Twelve apparently healthy participants (8 females) aged >65 years (72 ± 3.7 years) completed the study. Bipedal postural sway, four square step test, timed up and go, Y-balance (anterior reach only) and force-time characteristics of sit-to-stand performance were used to assess standing and dynamic balance. Attention and working memory were assessed using a serial 3s and 7s subtraction task during seated rest and completion of the bipedal standing assessment and Y-balance test. This battery of assessments was completed on two separate occasions, once following the consumption of a non-ergogenic placebo and again following the consumption of 3 mg·kg -1 caffeine. The administration of treatments was randomised, counterbalanced and double-blind. Caffeine reduced performance in the bipedal standing balance assessments, evidenced by an increase in COP ML , COP Path , COP Velocity . Performance during the dynamic balance tests was unaffected, other than rate of force development during the sit-to-stand, which was improved following caffeine ingestion. The introduction of a cognitive dual task had either limited effects, or improved facets of bipedal standing balance, whilst performance during the dynamic balance task was significantly reduced. In both balance assessments, there was evidence for a reduction in the performance of the cognitive task when both the balance and cognitive tests were performed simultaneously, with this effect not modulated by caffeine consumption. These findings refute the idea that caffeine ingestion may have positive effects on balance performance. However, despite a caffeine-induced reduction in bipedal standing balance, it is unlikely that caffeine ingestion would exacerbate fall risk given the limited effects in the dynamic balance tests. Future work should establish if these effects are generalisable to older frail participants and if caffeine can modulate the detrimental effects of an acute exercise bout on balance performance.",2020,"Performance during the dynamic balance tests was unaffected, other than rate of force development during the sit-to-stand, which was improved following caffeine ingestion.","['older frail participants', 'older adults', 'Older Adults', 'Twelve apparently healthy participants (8 females) aged >65 years (72 ± 3.7 years) completed the study']","['Caffeine', '3 mg·kg -1 caffeine consumption', 'ergogenic placebo', 'Acute Caffeine Ingestion']","['Bipedal postural sway, four square step test, timed up and go, Y-balance (anterior reach only) and force-time characteristics of sit-to-stand performance', 'Cognitive Dual Task Performance', 'bipedal standing balance', 'balance performance', 'COP ML , COP Path , COP Velocity ', 'Attention and working memory']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0948365', 'cui_str': 'Caffeine consumption'}, {'cui': 'C2936450', 'cui_str': 'Ergogenic Substances'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0056471', 'cui_str': 'creatinolfosfate'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",12.0,0.0494809,"Performance during the dynamic balance tests was unaffected, other than rate of force development during the sit-to-stand, which was improved following caffeine ingestion.","[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Tallis', 'Affiliation': 'Centre for Applied Biological and Exercise Sciences, Alison Gingell Building, Coventry University, Priory Street, Coventry CV15FB, UK.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Bradford', 'Affiliation': 'Centre for Applied Biological and Exercise Sciences, Alison Gingell Building, Coventry University, Priory Street, Coventry CV15FB, UK.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Duncan', 'Affiliation': 'Centre for Applied Biological and Exercise Sciences, Alison Gingell Building, Coventry University, Priory Street, Coventry CV15FB, UK.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Leddington-Wright', 'Affiliation': 'Centre for Applied Biological and Exercise Sciences, Alison Gingell Building, Coventry University, Priory Street, Coventry CV15FB, UK.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Higgins', 'Affiliation': 'Centre for Applied Biological and Exercise Sciences, Alison Gingell Building, Coventry University, Priory Street, Coventry CV15FB, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hill', 'Affiliation': 'Centre for Applied Biological and Exercise Sciences, Alison Gingell Building, Coventry University, Priory Street, Coventry CV15FB, UK.'}]",Nutrients,['10.3390/nu12123653'] 1571,33259976,A Randomized Controlled Trial to Assess the Effect of Lidocaine Administered via Throat Spray and Nebulization in Patients with Refractory Chronic Cough.,"BACKGROUND Refractory chronic cough (RCC) is a debilitating condition for which there are no licensed treatments. Lidocaine is a nonselective inhibitor of voltage-gated sodium channels with potential antitussive effects, but randomized placebo-controlled studies evaluating its efficacy in RCC are lacking. OBJECTIVE To investigate the efficacy of nebulized lidocaine and lidocaine throat spray versus matched placebos in RCC. METHODS This was a randomized, double-blind, double-dummy, placebo-controlled, 3-way crossover study, comparing the effect of single doses of nebulized lidocaine with lidocaine delivered by a throat spray and matched placebo. The primary end point was cough frequency over the 10 hours following treatment. Secondary end points were visual analog scale scores for urge-to-cough and cough severity; an exploratory analysis evaluated hourly cough rates up to 5 hours after treatment. RESULTS Twenty-six subjects with RCC were recruited (22 females; mean age, 53.5 ± 12.1 years; FEV 1 %predicted, 105.2 ± 16.8 L; forced vital capacity %predicted, 112.4 ± 18 L). Lidocaine throat spray, but not nebulized lidocaine, significantly reduced 10-hour cough frequency as compared with placebo (throat spray, 22.6 coughs/h; nebulization, 26.9 coughs/h; and placebos, 27.6 coughs/h; P = .04,). Lidocaine throat spray showed the greatest effect on cough compared with placebo in the first hour after administration (31.7 coughs/h vs 74.2 coughs/h; P = .004). Both nebulizer and spray treatments significantly alleviated urge-to-cough and cough severity visual analog scale scores compared with placebo (P < .05). There were no serious adverse events associated with lidocaine therapy. CONCLUSIONS Lidocaine throat spray was effective in reducing cough frequency in patients with RCC. Voltage-gated sodium channel inhibitors applied to pharynx have potential as therapies for RCC.",2021,Both nebulizer and spray treatments significantly alleviated urge-to-cough and cough severity VAS compared with placebo (p <0.05).,"['Patients with Refractory Chronic Cough', 'Twenty-six subjects with RCC were recruited [22 females, mean', 'RCC patients']","['placebo', 'lidocaine throat spray', 'Lidocaine throat spray', 'lidocaine', 'nebulized lidocaine', 'VGSC inhibitors', 'RCC', 'Lidocaine', 'Lidocaine Administered via Throat Spray and Nebulization', 'nebulized lidocaine with lidocaine']","['10-hour cough frequency', 'visual analogue scores (VAS) for urge-to-cough and cough severity; an exploratory analysis evaluated hourly cough rates', 'alleviated urge-to-cough and cough severity VAS', 'cough', 'cough frequency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4552486', 'cui_str': 'Refractory chronic cough'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C3494198', 'cui_str': 'Channel Blockers, Voltage-Gated Sodium'}, {'cui': 'C4552486', 'cui_str': 'Refractory chronic cough'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}]",26.0,0.48128,Both nebulizer and spray treatments significantly alleviated urge-to-cough and cough severity VAS compared with placebo (p <0.05).,"[{'ForeName': 'Rayid', 'Initials': 'R', 'LastName': 'Abdulqawi', 'Affiliation': 'University of Manchester, Division of Infection, Immunity and Respiratory Medicine, and Manchester Academic Health Science Centre, Manchester, United Kingdom; Dr. Sulaiman Al Habib Medical Group, Riyadh, Saudi Arabia; Department of Medicine, Alfaisal University, Riyadh, Saudi Arabia; Manchester University NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Satia', 'Affiliation': 'University of Manchester, Division of Infection, Immunity and Respiratory Medicine, and Manchester Academic Health Science Centre, Manchester, United Kingdom; McMaster University, Department of Medicine, Division of Respirology, Hamilton, ON, Canada.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Kanemitsu', 'Affiliation': 'University of Manchester, Division of Infection, Immunity and Respiratory Medicine, and Manchester Academic Health Science Centre, Manchester, United Kingdom; Manchester University NHS Foundation Trust, Manchester, United Kingdom; Department of Respiratory Medicine, Allergy and Clinical Immunology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Saifudin', 'Initials': 'S', 'LastName': 'Khalid', 'Affiliation': 'University of Manchester, Division of Infection, Immunity and Respiratory Medicine, and Manchester Academic Health Science Centre, Manchester, United Kingdom; East Lancashire Hospitals NHS Trust, Royal Blackburn Teaching Hospital, Blackburn, United Kingdom.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Holt', 'Affiliation': 'University of Manchester, Division of Infection, Immunity and Respiratory Medicine, and Manchester Academic Health Science Centre, Manchester, United Kingdom; Manchester University NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Dockry', 'Affiliation': 'University of Manchester, Division of Infection, Immunity and Respiratory Medicine, and Manchester Academic Health Science Centre, Manchester, United Kingdom; Manchester University NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Ashley A', 'Initials': 'AA', 'LastName': 'Woodcock', 'Affiliation': 'University of Manchester, Division of Infection, Immunity and Respiratory Medicine, and Manchester Academic Health Science Centre, Manchester, United Kingdom; Manchester University NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Jaclyn A', 'Initials': 'JA', 'LastName': 'Smith', 'Affiliation': 'University of Manchester, Division of Infection, Immunity and Respiratory Medicine, and Manchester Academic Health Science Centre, Manchester, United Kingdom; Manchester University NHS Foundation Trust, Manchester, United Kingdom. Electronic address: jacky.smith@manchester.ac.uk.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.11.037'] 1572,33047325,The Coping with and Caring for Infants with Special Needs intervention was associated with improved motor development in preterm infants.,"AIM We compared the impact of standard infant physiotherapy and the family-centred programme, Coping with and Caring for Infants with Special Needs (COPCA), in infants born before 32 weeks without significant brain lesions. METHODS This randomised controlled trial was carried out in patients' homes and outpatient settings in Switzerland between January 2016 and October 2019. We used data from the national SwissNeoNet register and an assessment battery that included infant and family outcomes and video analyses of therapy sessions. The Infant Motor Profile was the primary outcome instrument. RESULTS The COPCA group comprised six boys and two girls with a median gestational age of 27 weeks (range 25-30), and the standard care group comprised seven boys and one girl with a median gestational age of 29.5 weeks (range 26-31). COPCA participants improved significantly more between baseline and 18 months in the IMP variation (9.0 percentage points, 95% confidence interval: 0.3-17.5) and performance (12.0 percentage points, 95% confidence interval: 4.1-20.6) domains than standard care participants. COPCA coaching was positively associated with IMP scores at 18 months, but some standard care actions were negatively associated. CONCLUSION COPCA was associated with better motor outcome in infants born before 32 weeks than standard infant physiotherapy.",2021,"COPCA participants improved significantly more between baseline and 18 months in the IMP variation (9.0 percentage points, 95% confidence interval 0.3-17.5) and performance (12.0 percentage points, 95% confidence interval 4.1-20.6) domains than standard care participants.","['preterm infants', 'Infants with Special Needs (COPCA), in infants born before 32 weeks without significant brain lesions', 'group comprised six boys and two girls with a median gestational age of 27 weeks (range 25-30) and the standard care group comprised seven boys and one girl with a median gestational age of 29.5 weeks (range 26-31', ""patients' homes and outpatient settings in Switzerland between January 2016 and October 2019""]","['COPCA coaching', 'COPCA', 'standard infant physiotherapy and the family-centred programme, Coping With and Caring']","['IMP scores', 'IMP variation']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0221505', 'cui_str': 'Lesion of brain'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}]","[{'cui': 'C0021533', 'cui_str': 'Inosine monophosphate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}]",,0.179955,"COPCA participants improved significantly more between baseline and 18 months in the IMP variation (9.0 percentage points, 95% confidence interval 0.3-17.5) and performance (12.0 percentage points, 95% confidence interval 4.1-20.6) domains than standard care participants.","[{'ForeName': 'Schirin', 'Initials': 'S', 'LastName': 'Akhbari Ziegler', 'Affiliation': 'School of Health Professions, Institute of Physiotherapy, Zurich University of Applied Sciences ZHAW, Winterthur, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'von Rhein', 'Affiliation': 'Department of Pediatrics, Kantonsspital Winterthur, Winterthur, Switzerland.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Meichtry', 'Affiliation': 'School of Health Professions, Institute of Physiotherapy, Zurich University of Applied Sciences ZHAW, Winterthur, Switzerland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Wirz', 'Affiliation': 'School of Health Professions, Institute of Physiotherapy, Zurich University of Applied Sciences ZHAW, Winterthur, Switzerland.'}, {'ForeName': 'Tjitske', 'Initials': 'T', 'LastName': 'Hielkema', 'Affiliation': 'Department of Pediatrics, Division of Developmental Neurology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Mijna', 'Initials': 'M', 'LastName': 'Hadders-Algra', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Pediatrics, Division of Developmental Neurology, Groningen, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15619'] 1573,33050760,A pooled safety analysis of peficitinib (ASP015K) in Asian patients with rheumatoid arthritis treated over a median of 2 years.,"OBJECTIVE To evaluate the safety of peficitinib for the treatment of rheumatoid arthritis (RA) in Asian patients. METHODS Safety data from one Phase 2b, two Phase 3, and one open-label long-term extension study [data cut-off 31 May 2018] were pooled into Phase 3 studies (peficitinib 100 and 150 mg/day, and placebo) and Phase 2/3 studies (all peficitinib-treated patients). Incidence rates per 100 patient-years (PY) of adverse events (AEs) of special interest were calculated. RESULTS Overall, 1052 patients received peficitinib for 2336.3 PY of exposure (median 2.1 years); four deaths occurred, including one death after the studies. AE incidence was similar across peficitinib 100 and 150 mg/day groups (Phase 3 studies). Respective peficitinib and placebo incidence rates (95% confidence interval) per 100 PY were 2.9 (1.9, 4.6) and 0.0 for serious infections, 5.7 (4.2, 7.9) and 2.3 (0.6, 9.4) for herpes zoster-related disease, and 0.6 (0.2, 1.6) and 1.2 (0.2, 8.3) for malignancies (excluding non-melanoma skin cancer) (Phase 3 studies), and 0.1 (0.0, 0.3) for venous thromboembolism in all peficitinib-treated patients (Phase 2/3 studies). CONCLUSION Peficitinib was well tolerated in Asian patients with RA over a median of 2 years, with no observed dose or temporal dependency for AEs with prolonged administration.",2021,"Respective peficitinib and placebo incidence rates (95% confidence interval) per 100 PY were 2.9 (1.9, 4.6) and 0.0 for serious infections, 5.7 (4.2, 7.9) and 2.3 (0.6, 9.4) for herpes zoster-related disease, and 0.6 (0.2, 1.6) and 1.2 (0.2, 8.3) for malignancies (excluding non-melanoma skin cancer)","['Asian patients with rheumatoid arthritis treated over a median of 2 years', 'Asian patients with RA', 'Asian patients']","['peficitinib (ASP015K', 'placebo', 'peficitinib']","['Respective peficitinib and placebo incidence rates', 'AE incidence', 'Incidence rates', 'venous thromboembolism', 'tolerated']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4505522', 'cui_str': 'peficitinib'}, {'cui': 'C4505523', 'cui_str': 'ASP015K'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4505522', 'cui_str': 'peficitinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}]",,0.140023,"Respective peficitinib and placebo incidence rates (95% confidence interval) per 100 PY were 2.9 (1.9, 4.6) and 0.0 for serious infections, 5.7 (4.2, 7.9) and 2.3 (0.6, 9.4) for herpes zoster-related disease, and 0.6 (0.2, 1.6) and 1.2 (0.2, 8.3) for malignancies (excluding non-melanoma skin cancer)","[{'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health Japan, Kitakyushu, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Rokuda', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Izutsu', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Kaneko', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Musashi', 'Initials': 'M', 'LastName': 'Fukuda', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Kato', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}]",Modern rheumatology,['10.1080/14397595.2020.1836789'] 1574,33051867,Developing a fidelity measure of early intervention programs for children with neuromotor disorders.,"AIM To describe the development of an intervention-specific fidelity measure and its utilization and to determine whether the newly developed Sitting Together and Reaching to Play (START-Play) intervention was implemented as intended. Also, to quantify differences between START-Play and usual early intervention (uEI) services. METHOD A fidelity measure for the START-Play intervention was developed for children with neuromotor disorders by: (1) identifying key intervention components, (2) establishing a measurement coding system, and (3) testing the reliability of instrument scores. After establishing acceptable interrater reliability, 103 intervention videos from the START-Play randomized controlled trial were coded and compared between the START-Play and uEI groups to measure five dimensions of START-Play fidelity, including adherence, dosage, quality of intervention, participant responsiveness, and program differentiation. RESULTS Fifteen fidelity variables out of 17 had good to excellent interrater reliability evidence with intraclass correlation coefficients (ICCs) ranging from 0.77 to 0.95. The START-Play therapists met the criteria for acceptable fidelity of the intervention (rates of START-Play key component use ≥0.8; quality ratings ≥3 [on a scale of 1-4]). The START-Play and uEI groups differed significantly in rates of START-Play key component use and quality ratings. INTERPRETATION The START-Play fidelity measure successfully quantified key components of the START-Play intervention, serving to differentiate START-Play from uEI.",2021,The START-Play therapists met the criteria for acceptable fidelity of the intervention (rates of START-Play key component use ≥0.8; quality ratings ≥3 [on a scale of 1-4]).,"['children with neuromotor disorders by', 'children with neuromotor disorders']","['START-Play intervention', 'newly developed Sitting Together and Reaching to Play (START-Play) intervention']","['rates of START-Play key component use and quality ratings', 'START-Play fidelity, including adherence, dosage, quality of intervention, participant responsiveness, and program differentiation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}]",,0.0176289,The START-Play therapists met the criteria for acceptable fidelity of the intervention (rates of START-Play key component use ≥0.8; quality ratings ≥3 [on a scale of 1-4]).,"[{'ForeName': 'Mihee', 'Initials': 'M', 'LastName': 'An', 'Affiliation': 'Department of Physical Therapy, Kaya University, Gimhae, Republic of Korea.'}, {'ForeName': 'Jayden', 'Initials': 'J', 'LastName': 'Nord', 'Affiliation': 'Nebraska Center for Research on Children, Youth, Families and Schools, University of Nebraska, Lincoln, NE, USA.'}, {'ForeName': 'Natalie A', 'Initials': 'NA', 'LastName': 'Koziol', 'Affiliation': 'Nebraska Center for Research on Children, Youth, Families and Schools, University of Nebraska, Lincoln, NE, USA.'}, {'ForeName': 'Stacey C', 'Initials': 'SC', 'LastName': 'Dusing', 'Affiliation': 'Division of Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Audrey E', 'Initials': 'AE', 'LastName': 'Kane', 'Affiliation': 'Department of Physical Therapy, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Michele A', 'Initials': 'MA', 'LastName': 'Lobo', 'Affiliation': 'Department of Physical Therapy, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Sarah W', 'Initials': 'SW', 'LastName': 'Mccoy', 'Affiliation': 'Department of Physical Therapy, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Regina T', 'Initials': 'RT', 'LastName': 'Harbourne', 'Affiliation': 'Department of Physical Therapy, Duquesne University, Pittsburgh, PA, USA.'}]",Developmental medicine and child neurology,['10.1111/dmcn.14702'] 1575,33053823,"Vitamin D Supplementation Does Not Impact Resting Metabolic Rate, Body Composition and Strength in Vitamin D Sufficient Physically Active Adults.","Supplementation with the most efficient form of Vitamin D (VitD3) results in improvements in energy metabolism, muscle mass and strength in VitD deficient individuals. Whether similar outcomes occur in VitD sufficient individuals' remains to be elucidated. The aim of this study is to determine the effect of VitD3 supplementation on resting metabolic rate (RMR), body composition and strength in VitD sufficient physically active young adults. Participants completed pre-supplementation testing before being matched for sunlight exposure and randomly allocated in a counterbalanced manner to the VitD3 or placebo group. Following 12 weeks of 50 IU/kg body-mass VitD3 supplementation, participants repeated the pre-supplementation testing. Thirty-one adults completed the study (19 females and 12 males; mean ± standard deviation (SD); age = 26.6 ± 4.9 years; BMI = 24.2 ± 4.1 kg·m 2 ). The VitD group increased serum total 25(OH)D by 30 nmol/L while the placebo group decreased total serum concentration by 21 nmol/L, reaching 123 (51) and 53 (42.2) nmol/L, respectively. There were no significant changes in muscle strength or power, resting metabolic rate and body composition over the 12-week period. Physically active young adults that are VitD sufficient have demonstrated that no additional physiological effects of achieving supraphysiological serum total 25(OH)D concentrations after VitD3 supplementation.",2020,"There were no significant changes in muscle strength or power, resting metabolic rate and body composition over the 12-week period.","['Physically active young adults', 'VitD sufficient physically active young adults', 'Thirty-one adults completed the study (19 females and 12 males; mean ± standard deviation (SD); age = 26.6 ± 4.9 years; BMI = 24.2 ± 4.1 kg·m 2 ', 'VitD deficient individuals']","['Vitamin D Supplementation', 'placebo', 'VitD3 or placebo', 'VitD3 supplementation', 'Vitamin D (VitD3']","['muscle strength or power, resting metabolic rate and body composition', 'resting metabolic rate (RMR), body composition and strength', 'total serum concentration', 'serum total 25(OH)D', 'energy metabolism, muscle mass and strength']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0919758', 'cui_str': 'Vitamin D measurement'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0523979', 'cui_str': 'Vitamin D3 measurement'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}]",31.0,0.13748,"There were no significant changes in muscle strength or power, resting metabolic rate and body composition over the 12-week period.","[{'ForeName': 'Karina Romeu', 'Initials': 'KR', 'LastName': 'Montenegro', 'Affiliation': 'School of Pharmacy and Biomedical Sciences, Curtin Health Innovation Research Institute, Curtin University, Perth, WA 6102, Australia.'}, {'ForeName': 'Vinicius', 'Initials': 'V', 'LastName': 'Cruzat', 'Affiliation': 'Faculty of Health, Torrens University Australia, Melbourne, VIC 3000, Australia.'}, {'ForeName': 'Hilton', 'Initials': 'H', 'LastName': 'Melder', 'Affiliation': 'Faculty of Health, Torrens University Australia, Melbourne, VIC 3000, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Jacques', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, WA 6102, Australia.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Newsholme', 'Affiliation': 'School of Pharmacy and Biomedical Sciences, Curtin Health Innovation Research Institute, Curtin University, Perth, WA 6102, Australia.'}, {'ForeName': 'Kagan J', 'Initials': 'KJ', 'LastName': 'Ducker', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, WA 6102, Australia.'}]",Nutrients,['10.3390/nu12103111'] 1576,33063296,Impact of Geriatric Pharmacy Specialist Interventions to Reduce Potentially Inappropriate Medication Among Hospitalized Elderly Patients at Medical Wards: A Prospective Quasi-Experimental Study.,"BACKGROUND Elderly patients are at greater risk of receiving potentially inappropriate medications (PIMs) and developing adverse drug events. Identification and correction of PIMs is essential to maximize medication safety. OBJECTIVE To determine the prevalence of PIMs on admission in Thai elderly patients admitted to a medical ward and to compare changes of PIMs on discharge, following comprehensive care by a ward pharmacist with or without a geriatric pharmacy specialist. PATIENTS AND METHOD A prospective, quasi-experimental study was performed at a tertiary university hospital in Bangkok, Thailand. Patients aged ≥ 60 years who were admitted to the medical ward were recruited and allocated to one of two groups: intervention (IG) and control (CG). The CG received pharmaceutical care from the ward pharmacist. The IG received pharmaceutical care from the geriatric pharmacy specialist along with the ward pharmacist. The 2012 Beers criteria were used to identify PIMs on admission, during hospitalization, and on discharge. RESULTS Prevalence of PIMs on admission was 43.3% (N = 187). On discharge, prevalence of PIMs in the IG decreased significantly compared to that on admission (21.3% and 43.3%, p < 0.05) and was significantly lower than in the CG (21.3% and 40.9%, p = 0.036). Moreover, the percentage of patients without PIMs on discharge in the IG was significantly higher than in the CG (78.7% and 59.1%, p < 0.0001). CONCLUSION Use of PIMs was common among hospitalized elderly patients on admission. Pharmaceutical care provided by a geriatric pharmacy specialist in conjunction with a ward pharmacist significantly reduced the prevalence of PIMs on discharge compared with on admission.",2021,Pharmaceutical care provided by a geriatric pharmacy specialist in conjunction with a ward pharmacist significantly reduced the prevalence of PIMs on discharge compared with on admission.,"['Patients aged\u2009≥', 'A prospective, quasi-experimental study was performed at a tertiary university hospital in Bangkok, Thailand', 'Hospitalized Elderly Patients at Medical Wards', 'hospitalized elderly patients on admission', '60\xa0years who were admitted to the medical ward', 'Thai elderly patients admitted to a medical ward and to compare changes of PIMs on discharge, following comprehensive care by a ward pharmacist with or without a geriatric pharmacy specialist', 'Elderly patients']","['intervention (IG) and control (CG', 'Geriatric Pharmacy Specialist Interventions']","['discharge, prevalence of PIMs', 'prevalence of PIMs on discharge', 'percentage of patients without PIMs on discharge']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0457453', 'cui_str': 'On admission'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0009586', 'cui_str': 'Comprehensive Healthcare'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",,0.0117656,Pharmaceutical care provided by a geriatric pharmacy specialist in conjunction with a ward pharmacist significantly reduced the prevalence of PIMs on discharge compared with on admission.,"[{'ForeName': 'Wajanakorn', 'Initials': 'W', 'LastName': 'Chivapricha', 'Affiliation': 'College of Pharmacy, Rangsit University, Pathumthani, Thailand.'}, {'ForeName': 'Varalak', 'Initials': 'V', 'LastName': 'Srinonprasert', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Thanarat', 'Initials': 'T', 'LastName': 'Suansanae', 'Affiliation': 'Division of Clinical Pharmacy, Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand. thanarat.sua@mahidol.ac.th.'}]",Drugs - real world outcomes,['10.1007/s40801-020-00214-7'] 1577,33063932,A randomized controlled trial of a structured exercise intervention after the completion of acute cancer treatment in adolescents and young adults.,"BACKGROUND Cancer treatments are frequently associated with impaired physical fitness, quality of life (QOL), and fatigue, often persisting into survivorship.  Studies in older adults with cancer have demonstrated benefits from exercise; however, this has not been rigorously investigated in adolescents and young adults (AYA). The aim of this study was to determine whether a structured 10-week exercise intervention was associated with improved cardiorespiratory fitness (VO 2peak ), fatigue, and QOL in AYA who have recently completed cancer treatment. METHOD Forty-three AYA (median age 21 ± 6 years) were randomly assigned to an exercise group (n = 22) or a control group (n = 21). The exercise group received a structured 10-week exercise program comprising progressive aerobic and resistance exercise; the control arm received routine care. VO 2peak was measured at baseline, 10 weeks, and six months. Fatigue and QOL were assessed by the FACIT fatigue scale and the PEDS QL, respectively. RESULTS Mean VO 2peak at baseline was 26.5 ± 7.2 mL.kg -1 .min -1 , which is substantially lower than population norms. The exercise group demonstrated significant improvement in VO 2peak at 10 weeks compared with controls (33.8 ± 8.1 vs 29.6 ± 7.6 mL.kg -1 .min -1 , P = 0.0002), but by six months, the difference was no longer significant (32.9 ± 7.0 vs 30.9 ± 11.0 mL.kg -1 .min -1 , P = 0.21). There were no significant differences in fatigue or total QOL scores between groups. CONCLUSION Cancer treatment is associated with reduced VO 2peak in AYA. Improvement in VO 2peak was accelerated by a 10-week exercise program; however, no significant benefit was observed in QOL or fatigue. The plateau in VO 2peak at six months suggests that a maintenance exercise program may be beneficial.",2021,"There were no significant differences in fatigue or total QOL scores between groups. ","['Forty-three AYA (median age 21 ± 6 years', 'adolescents and young adults', 'adolescents and young adults (AYA', 'older adults with cancer']","['exercise group', 'structured exercise intervention', 'structured 10-week exercise program comprising progressive aerobic and resistance exercise; the control arm received routine care', 'structured 10-week exercise intervention']","['QOL or fatigue', 'FACIT fatigue scale', 'fatigue or total QOL scores', 'Fatigue and QOL', 'cardiorespiratory fitness (VO 2peak ), fatigue, and QOL', 'Mean VO', 'physical fitness, quality of life (QOL), and fatigue', 'VO 2peak']","[{'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}]",,0.0735769,"There were no significant differences in fatigue or total QOL scores between groups. ","[{'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Atkinson', 'Affiliation': 'Youth Cancer Service SA/NT, Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Murnane', 'Affiliation': 'ONTrac at Peter Mac, Victorian Adolescent and Young Adult Cancer Service, Melbourne, Australia.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Goddard', 'Affiliation': ""Department of Haematology and Oncology, Women's and Children's Hospital, North Adelaide, Australia.""}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Pendergrast', 'Affiliation': ""Department of Haematology and Oncology, Women's and Children's Hospital, North Adelaide, Australia.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Rogers', 'Affiliation': ""Department of Haematology and Oncology, Women's and Children's Hospital, North Adelaide, Australia.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Manudhane', 'Affiliation': ""Department of Haematology and Oncology, Women's and Children's Hospital, North Adelaide, Australia.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Osborn', 'Affiliation': 'Youth Cancer Service SA/NT, Royal Adelaide Hospital, Adelaide, Australia.'}]",Pediatric blood & cancer,['10.1002/pbc.28751'] 1578,33057132,Safety review of hydroxyprogesterone caproate in women with a history of spontaneous preterm birth.,"17-alpha-hydroxyprogesterone caproate (17P) has been in use for prevention of recurrent preterm birth since 2003 when the Meis trial was published. A requirement for Food and Drug Administration approval of 17P was a confirmatory trial, called ""PROLONG"", which was recently completed, but did not replicate the efficacy demonstrated in the Meis trial. This review analyzes the safety data from each trial, as well as integrated data from the two trials. The relative risks (95% CI) with 17P versus placebo in the integrated dataset were 0.66 (0.25-1.78) for miscarriage, 1.83 (0.68-4.91) for stillbirth, and 0.86 (0.53-1.41) for all fetal and neonatal death. The rate of gestational diabetes in the integrated dataset was 3.6% for 17P vs. 3.8% for placebo. Similar findings with low and comparable rates between 17P and placebo were also found for other adverse events. The integrated safety data demonstrate a favorable safety profile that was comparable to placebo.",2021,"The relative risks (95% CI) with 17P versus placebo in the integrated dataset were 0.66 (0.25-1.78) for miscarriage, 1.83 (0.68-4.91) for stillbirth, and 0.86 (0.53-1.41) for all fetal and neonatal death.",['women with a history of spontaneous preterm birth'],"['17-alpha-hydroxyprogesterone caproate (17P', 'hydroxyprogesterone caproate', 'placebo']","['rate of gestational diabetes', 'relative risks']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}]","[{'cui': 'C0044971', 'cui_str': 'Hydroxyprogesterone caproate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}]",,0.407412,"The relative risks (95% CI) with 17P versus placebo in the integrated dataset were 0.66 (0.25-1.78) for miscarriage, 1.83 (0.68-4.91) for stillbirth, and 0.86 (0.53-1.41) for all fetal and neonatal death.","[{'ForeName': 'Baha', 'Initials': 'B', 'LastName': 'Sibai', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School-UTHealth, 6431 Fannin, Houston, TX, 77030, USA. baha.m.sibai@uth.tmc.edu.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Saade', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Medical Branch, University of Texas, Galveston, TX, USA.'}, {'ForeName': 'Anita F', 'Initials': 'AF', 'LastName': 'Das', 'Affiliation': 'Das Consulting, Guerneville, CA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Gudeman', 'Affiliation': 'AMAG Pharmaceuticals, Inc., Boston, MA, USA.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-00849-y'] 1579,33065208,Yoga Practice Predicts Improvements in Day-to-Day Pain in Women With Metastatic Breast Cancer.,"CONTEXT Women with metastatic breast cancer (MBC) experience a significant symptom burden, including cancer pain. Yoga is a mind-body discipline that has shown promise for alleviating cancer pain, but few studies have included patients with metastatic disease or examined the acute effects of yoga practice. OBJECTIVES To determine whether daily pain changed significantly during a randomized controlled trial of the Mindful Yoga program among women with MBC and whether time spent in yoga practice was related to daily pain. METHODS On alternate weeks during the intervention period, we collected daily measures of pain from a subset of 48 women randomized to either yoga (n = 30) or a support group condition (n = 18). We also assessed daily duration of yoga practice among patients randomized to yoga. RESULTS Pain levels were low for women in both conditions, and no differential treatment effects were found on daily pain. However, among women randomized to yoga, a dose/response relationship was found between yoga practice duration and daily pain. When patients had spent relatively more time practicing yoga across two consecutive days, they were more likely to experience lower pain on the next day. This finding is consistent with an earlier MBC study. Meditation practice showed the strongest association with lower daily pain. CONCLUSION Findings suggest that yoga practice (meditation practice in particular) is associated with acute improvements in cancer pain, and that yoga interventions may be more impactful if tested in a sample of patients with advanced cancer in which pain is relatively elevated.",2020,"RESULTS Pain levels were low for women in both conditions, and no differential treatment effects were found on daily pain.","['Women with Metastatic Breast Cancer', 'Women with metastatic breast cancer', 'women with MBC', 'advanced cancer patients']",['Mindful Yoga program'],"['Pain levels', 'yoga practice duration, and daily pain', 'cancer pain', 'daily pain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}]",48.0,0.0669837,"RESULTS Pain levels were low for women in both conditions, and no differential treatment effects were found on daily pain.","[{'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Carson', 'Affiliation': 'Department of Anesthesiology & Perioperative Medicine, Oregon Health & Science University, Portland, Oregon, USA. Electronic address: carsonja@ohsu.edu.'}, {'ForeName': 'Kimberly M', 'Initials': 'KM', 'LastName': 'Carson', 'Affiliation': 'Department of Anesthesiology & Perioperative Medicine, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Olsen', 'Affiliation': 'Center for Health Services Research in Primary Care, Durham VA Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Sanders', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Westbrook', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Keefe', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Porter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.10.009'] 1580,33260468,Longitudinal Changes in Food Addiction Symptoms and Body Weight among Adults in a Behavioral Weight-Loss Program.,"Interest in food addiction (FA) has increased, but little is known about its clinical implications or potential treatments. Using secondary analyses from a randomized controlled trial, we evaluated the associations between changes in FA, body weight, and ""problem food"" consumption during a 22-month behavioral weight-loss program consisting of an initial four-month in-person intervention, 12-month extended-care, and six-month follow-up ( n = 182). Food addiction was measured using the Yale Food Addiction Scale. ""Problem foods"" were identified from the literature and self-reporting. Multilevel modeling was used as the primary method of analysis. We hypothesized that reductions in problem food consumption during the initial treatment phase would be associated with long-term (22-month) FA reductions. As expected, we found that reductions in problem foods were associated with greater initial reductions in FA symptoms; however, they were also associated with a sharper rebound in symptoms over time ( p = 0.016), resulting in no significant difference at Month 22 ( p = 0.856). Next, we hypothesized that long-term changes in FA would be associated with long-term changes in body weight. Although both FA and weight decreased over time ( p s < 0.05), month-to-month changes in FA were not associated with month-to-month changes in weight ( p = 0.706). Instead, higher overall FA (i.e., mean scores over the course of the study) were associated with less weight loss ( p = 0.008) over time. Finally, we hypothesized that initial reductions in problem food consumption would be associated with long-term reductions in weight, but this relationship was not significant ( p s > 0.05). Given the complexity of the findings, more research is needed to identify interventions for long-term changes in FA and to elucidate the associations between problem foods, FA, and weight.",2020,"Although both FA and weight decreased over time ( p s < 0.05), month-to-month changes in FA were not associated with month-to-month changes in weight ( p = 0.706).",['Adults in a Behavioral Weight-Loss Program'],[],"['weight loss', 'problem food consumption', 'overall FA', 'Food addiction', 'FA, body weight, and ""problem food"" consumption', 'FA symptoms', 'Food Addiction Symptoms and Body Weight', 'Yale Food Addiction Scale. ']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}]",[],"[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4505163', 'cui_str': 'Food Addiction'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0175224,"Although both FA and weight decreased over time ( p s < 0.05), month-to-month changes in FA were not associated with month-to-month changes in weight ( p = 0.706).","[{'ForeName': 'Eliza L', 'Initials': 'EL', 'LastName': 'Gordon', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, P.O. Box 100165, Gainesville, FL 32610, USA.'}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Merlo', 'Affiliation': 'Department of Psychiatry, McKnight Brain Institute, University of Florida College of Medicine, L4-100K, P.O. Box 100256, Gainesville, FL 32611, USA.'}, {'ForeName': 'Patricia E', 'Initials': 'PE', 'LastName': 'Durning', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, P.O. Box 100165, Gainesville, FL 32610, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Perri', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, P.O. Box 100165, Gainesville, FL 32610, USA.'}]",Nutrients,['10.3390/nu12123687'] 1581,33260442,Dietary Contributors to Food Group Intake in Preschool Children Attending Family Childcare Homes: Differences between Latino and Non-Latino Providers.,"While there are several factors that contribute to the diet quality of children in childcare, one contributing factor in Family Childcare Homes (FCCHs) is the provider's ethnicity. However, research examining the food items provided in this setting is limited; in particular, with regards to differences between FCCHs of Latino and non-Latino providers. The aim of this study was to identify and describe the food items that contribute to food group intake in preschool-aged children attending FCCHs, and to examine differences by provider ethnicity. This secondary data analysis used baseline data from Healthy Start/Comienzos Sanos: a cluster-randomized trial. Children's dietary intake was collected using the Dietary Observation in Child Care method and entered into Nutrition Data System for Research software. Food groups were based on the Nutrition Coordinating Center classification. Contribution of food items to their respective food group was calculated as a proportion, using ratio of means and presented as a percentage. Ethnic differences were tested with ANCOVA ( p < 0.05) with Bonferroni adjustments for multiple comparisons. All providers ( n = 120) were female and 67.5% were Latino. Most fruit consumed by children was in the form of juice (85%), three-fourths of the grains consumed were refined (75%), and half of the sweets consumed were syrup/honey/jelly (50%). Most of the vegetables consumed were non-starchy (61%), nearly three-fourths of dairy consumed was low-fat (71%), and vegetable oils contributed the most to the fats group (89%). Food items differed by provider's ethnicity, with children cared for by non-Latino providers consuming a higher proportion of fruit juice, animal fats and a lower proportion of legumes ( p < 0.001 for all). Children with Latino providers consumed a lower proportion of non-starchy vegetables, low-fat dairy, and nuts/seeds ( p < 0.001 for all). FCCH providers could offer more whole fruits and grains and a greater variety of vegetables. Differences by ethnicity suggest providers could benefit from culturally tailored recommendations.",2020,"Children with Latino providers consumed a lower proportion of non-starchy vegetables, low-fat dairy, and nuts/seeds ( p < 0.001 for all).","['Children with Latino providers', 'Preschool Children', 'Attending Family Childcare Homes', 'preschool-aged children attending FCCHs', 'All providers ( n = 120) were female and 67.5% were Latino']",[],['proportion of non-starchy vegetables'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0042440', 'cui_str': 'Vegetable'}]",120.0,0.0335028,"Children with Latino providers consumed a lower proportion of non-starchy vegetables, low-fat dairy, and nuts/seeds ( p < 0.001 for all).","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ramirez', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Rhode Island, Kingston, RI 02881, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Vadiveloo', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Rhode Island, Kingston, RI 02881, USA.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Risica', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI 02912, USA.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'Gans', 'Affiliation': 'Department of Human Development & Family Sciences, University of Connecticut, Storrs, CT 06269, USA.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Greaney', 'Affiliation': 'Department of Health Studies, University of Rhode Island, Kingston, RI 02881, USA.'}, {'ForeName': 'Noereem Z', 'Initials': 'NZ', 'LastName': 'Mena', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Rhode Island, Kingston, RI 02881, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Cooksey Stowers', 'Affiliation': 'Department of Allied Health Sciences, University of Connecticut, Storrs, CT 06269, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Tovar', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Rhode Island, Kingston, RI 02881, USA.'}]",Nutrients,['10.3390/nu12123686'] 1582,33259459,Open-label placebo for chronic low back pain: a 5-year follow-up.,"ABSTRACT Long-term follow-up of patients treated with open-label placebo (OLP) are nonexistent. In this article, we report a 5-year follow-up of a 3-week OLP randomized controlled trial (RCT) in patients with chronic low back pain. We recontacted the participants of original RCT and reassessed their pain, disability, and use of pain medication. We obtained follow-up data from 55 participants (82% of those who took OLP during the parent RCT), with a mean elapsed time between the end of the 3 weeks placebo trial and the follow-up interview of 55 months (SD = 7.85). We found significant reductions in both pain and disability between the baseline assessment immediately before the 3 weeks trial with placebo pills and the original trial endpoint (P < 0.00001 for the 2 primary outcomes of pain and disability). At the 5-year follow-up, we found no significant differences in either outcome between original trial endpoint and follow-up. Improvements persisted after 5 years and were accompanied by substantial reductions compared with baseline in the use of pain medication (from 87% to 38%), comprising analgesics (from 80% to 31%), antidepressants (from 24% to 11%), and benzodiazepines (from 15% to 5%). By contrast, the use of alternative approaches to pain management increased (from 18% to 29%). Although the reduction in pain and medication is comparable with the improvements that occurred in the original study, a major limitation of this long-term follow-up is the absence of controls for spontaneous improvement and new cointerventions. Nonetheless, our data suggest that reductions in pain and disability after OLP may be long lasting.",2021,"Improvements persisted after 5-years and were accompanied by substantial reductions compared to baseline in the use of pain medication (from 87% to 38%), comprising analgesics (from 80% to 31%) antidepressants (from 24% to 11%), and benzodiazepines (from 15% to 5%).","['chronic low back pain patients', 'chronic low back pain']","['open-label placebo (OLP', 'Open-label placebo', 'benzodiazepines', 'placebo']","['pain medication', 'pain management', 'pain and medication', 'pain and disability']","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",,0.140407,"Improvements persisted after 5-years and were accompanied by substantial reductions compared to baseline in the use of pain medication (from 87% to 38%), comprising analgesics (from 80% to 31%) antidepressants (from 24% to 11%), and benzodiazepines (from 15% to 5%).","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Carvalho', 'Affiliation': 'ISPA-Instituto Universitário de Ciências Psicológicas, Sociais e da Vida, Rua Jardim do Tabaco, Lisbon, Portugal.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pais', 'Affiliation': 'Santa Casa da Misericórdia de Lisboa, Largo Trindade Coelho, Lisbon, Portugal.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Cunha', 'Affiliation': 'Unidade de Terapia de Dor do Hospital de Egas Moniz/Centro Hospitalar de Lisboa Ocidental, Lisbon, Portugal.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Rebouta', 'Affiliation': 'Unidade de Terapia de Dor do Hospital de Egas Moniz/Centro Hospitalar de Lisboa Ocidental, Lisbon, Portugal.'}, {'ForeName': 'Ted J', 'Initials': 'TJ', 'LastName': 'Kaptchuk', 'Affiliation': 'Program in Placebo Studies, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Irving', 'Initials': 'I', 'LastName': 'Kirsch', 'Affiliation': 'Program in Placebo Studies, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.'}]",Pain,['10.1097/j.pain.0000000000002162'] 1583,33268143,"Impact of specialized oral nutritional supplement on clinical, nutritional, and functional outcomes: A randomized, placebo-controlled trial in community-dwelling older adults at risk of malnutrition.","BACKGROUND & AIMS The world's over-65 population is expanding rapidly, and the risk of malnutrition is prevalent in this population. Meeting nutritional needs is a recognized strategy to reduce and address multiple debilitating adverse health outcomes associated with malnutrition. The objective of this randomized, controlled trial was to determine the effects of oral nutritional supplement (ONS) containing beta-hydroxy-beta-methylbutyrate (HMB), along with dietary counseling, on health outcomes in community-dwelling older adults at risk of malnutrition. METHODS Strengthening Health In ELDerly through nutrition (SHIELD) studied adults aged ≥ 65 years in Singapore who were recruited between August 2017 and March 2019. Participants were community ambulant and classified as medium or high risk for malnutrition using Malnutrition Universal Screening Tool (MUST). Participants (n = 811) were randomly assigned to one of two study treatments for 180 days: (i) two servings/day of ONS containing HMB with dietary counseling (n = 405) or (ii) two servings/day of placebo supplement with dietary counseling (n = 406). The primary composite outcome was 'survival without hospital (re)admission and with at least 5% weight gain to day 180'. Dietary intakes, nutritional and functional outcomes were measured at baseline, 30, 90, and 180 days. RESULTS A higher proportion in intervention group met the 180-day primary composite outcome compared to placebo (33.4% vs. 8.7%, P < 0.001), largely driven by body weight component (36.2% vs. 9.4%, P < 0.001). Survival and hospital (re)admission rate were not significantly different between the groups. Weight, BMI, and mid upper arm circumference were significantly greater in the intervention group compared to placebo during the study (all P < 0.001), and at days 30, 90, and 180 (all P < 0.05). The odds of having better nutritional status during the study were also significantly higher in the intervention group compared to placebo, as measured using MUST risk (OR = 2.68, P < 0.001) and vitamin D status (OR = 4.23, P < 0.001). Intervention group had significantly higher energy, protein, fat, and carbohydrate intakes than the placebo group (all P ≤ 0.017). Leg strength at day 90 was significantly greater for the intervention group than for the placebo group (LSM ± SE: 12.85 ± 0.22 vs. 12.17 ± 0.22; P = 0.030). Handgrip strength for females was significantly higher at day 180 for the intervention group compared to placebo (LSM ± SE: 14.18 ± 0.17 vs. 13.70 ± 0.17; P = 0.048). Within the low appendicular skeletal muscle mass index (ASMI) subgroup, the intervention group had significantly greater calf circumference at days 90 and 180 compared to placebo (both P ≤ 0.0289). CONCLUSIONS For community-dwelling older adults at risk of malnutrition, daily consumption of specialized ONS containing HMB and vitamin D for six months, along with dietary counseling, significantly improved nutritional and functional outcomes compared to placebo supplement with dietary counseling. CLINICAL TRIAL REGISTRATION www.ClinicalTrials.govNCT03245047.",2021,Handgrip strength for females was significantly higher at day 180 for the intervention group compared to placebo (LSM ± SE: 14.18 ± ,"['Participants (n\xa0', 'In ELDerly through nutrition (SHIELD) studied adults aged\xa0≥\xa065 years in Singapore who were recruited between August 2017 and March 2019', 'Strengthening Health', '811', 'community-dwelling older adults at risk of malnutrition', 'Participants were community ambulant and classified as medium or high risk for malnutrition using Malnutrition Universal Screening Tool (MUST']","['oral nutritional supplement (ONS) containing beta-hydroxy-beta-methylbutyrate (HMB', 'placebo', 'ONS containing HMB with dietary counseling', 'specialized oral nutritional supplement', 'dietary counseling', 'placebo supplement with dietary counseling']","['Handgrip strength for females', 'Weight, BMI, and mid upper arm circumference', 'nutritional and functional outcomes', 'survival without hospital (re)admission and with at least 5% weight gain to day 180', 'body weight component', 'vitamin D status ', 'calf circumference', 'higher energy, protein, fat, and carbohydrate intakes', 'Leg strength', 'Survival and hospital (re)admission rate', 'clinical, nutritional, and functional outcomes', 'Dietary intakes, nutritional and functional outcomes']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1532006', 'cui_str': 'Malnutrition universal screening tool'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0053454', 'cui_str': '3-hydroxyisovaleric acid'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205555', 'cui_str': 'Special'}]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0562351', 'cui_str': 'Mid upper arm circumference'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}]",811.0,0.338833,Handgrip strength for females was significantly higher at day 180 for the intervention group compared to placebo (LSM ± SE: 14.18 ± ,"[{'ForeName': 'Samuel Teong Huang', 'Initials': 'STH', 'LastName': 'Chew', 'Affiliation': 'Department of Geriatric Medicine, Changi General Hospital, Singapore; Yong Loo Lin School of Medicine, National University of Singapore, Singapore. Electronic address: samuel.chew.t.h@singhealth.com.sg.'}, {'ForeName': 'Ngiap Chuan', 'Initials': 'NC', 'LastName': 'Tan', 'Affiliation': 'SingHealth Polyclinics, Singapore; SingHealth-Duke NUS Family Medicine Academic Clinical Program, Singapore.'}, {'ForeName': 'Magdalin', 'Initials': 'M', 'LastName': 'Cheong', 'Affiliation': 'Department of Dietetic & Food Services, Changi General Hospital, Singapore.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Oliver', 'Affiliation': 'Abbott Nutrition Research and Development, Columbus, OH, USA.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Baggs', 'Affiliation': 'Abbott Nutrition Research and Development, Columbus, OH, USA.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Choe', 'Affiliation': 'Abbott Nutrition Research and Development, Columbus, OH, USA.'}, {'ForeName': 'Choon How', 'Initials': 'CH', 'LastName': 'How', 'Affiliation': 'SingHealth-Duke NUS Family Medicine Academic Clinical Program, Singapore; Care and Health Integration, Changi General Hospital, Singapore.'}, {'ForeName': 'Wai Leng', 'Initials': 'WL', 'LastName': 'Chow', 'Affiliation': 'Health Services Research, Changi General Hospital, Singapore.'}, {'ForeName': 'Cynthia Yan Ling', 'Initials': 'CYL', 'LastName': 'Tan', 'Affiliation': 'SingHealth Polyclinics, Singapore.'}, {'ForeName': 'Shuyi Charmaine', 'Initials': 'SC', 'LastName': 'Kwan', 'Affiliation': 'SingHealth Polyclinics, Singapore.'}, {'ForeName': 'Farah Safdar', 'Initials': 'FS', 'LastName': 'Husain', 'Affiliation': 'SingHealth Polyclinics, Singapore.'}, {'ForeName': 'Yen Ling', 'Initials': 'YL', 'LastName': 'Low', 'Affiliation': 'Abbott Nutrition Research and Development, Asia-Pacific Center, Singapore.'}, {'ForeName': 'Dieu Thi Thu', 'Initials': 'DTT', 'LastName': 'Huynh', 'Affiliation': 'Abbott Nutrition Research and Development, Asia-Pacific Center, Singapore.'}, {'ForeName': 'Siew Ling', 'Initials': 'SL', 'LastName': 'Tey', 'Affiliation': 'Abbott Nutrition Research and Development, Asia-Pacific Center, Singapore.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.10.015'] 1584,33269553,Comparison of high-flow oxygenation with noninvasive ventilation in COPD exacerbation: A crossover clinical trial.,"OBJECTIVES To compare the therapeutic effects of high-flow-oxygen-Therapy (HFT) and noninvasive-ventilation (NIV) for stabilizing chronic obstructive pulmonary disease during exacerbation. METHODS In this randomized clinical trial at Masih-Daneshvari hospital, between July 2019 and Oct 2019, 30 exacerbated-COPD-patient with PaCO 2 64.58 ± 11.61 mm Hg, Respiratory Rate 24.43 ± 2.75, and PH 7.31 ± 0.02 were divided into two groups, N = 15. By a simple randomized allocation, patients receive either NIV or HFT for 1 hour, and following a washout period of 30 minutes, they switched to the other treatment option. Arterial Blood Gas Parameters, as well as Respiratory Rate (RR), Dyspnea Score, Heart Rate (HR), and Oxygen Saturation (SO 2 ), were compared before and after the intervention and between groups. RESULTS Baseline patient characteristics were similar in the two groups. Pre and post-analysis revealed that in both groups, all improved significantly. After the first period, there was no difference in all parameters between groups except for SO 2 which was significantly higher in HFT (%92.1 ± 1) than that of NIV (%89 ± 1), P = .001. Likewise, following the washout period, patients in HFT and NIV had a dyspnea score of 1.93 ± 0.7 and 2.73 ± 0.9, respectively, P = .01. No carryover-effect and was observed but the period effect was significant for some outcomes. A significant improvement in SO 2 and HR was observed by HFT according to treatment effect by combining two periods' results. During the study, no side effects were reported. CONCLUSION In this short-term study HFT appears feasible for patients with COPD exacerbation to reduce dyspnea score and improve respiratory distress.",2021,In this short-term study HFT appears feasible for patients with COPD exacerbation to reduce dyspnea score and improve respiratory distress.,"['COPD exacerbation', 'stabilizing chronic obstructive pulmonary disease during exacerbation', 'patients with COPD exacerbation', 'Masih-Daneshvari hospital, between July 2019 and Oct 2019, 30 exacerbated-COPD-patient with PaCO2 64.58±11.61 mmHg, Respiratory Rate 24.43±2.75 and PH 7.31±0.02 were divided into two groups, N= 15']","['HFT', 'high-flow-oxygen-Therapy (HFT) and noninvasive-ventilation (NIV', 'high-flow oxygenation with noninvasive ventilation', 'NIV or HFT']","['Arterial Blood Gas Parameters, as well as Respiratory Rate (RR), Dyspnea Score, Heart Rate (HR), and Oxygen Saturation (SO2', 'SO2 and HR', 'SO2', 'dyspnea score', 'dyspnea score and improve respiratory distress']","[{'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0436331', 'cui_str': 'Symptom aggravating factors'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}]","[{'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0038777', 'cui_str': 'Sulfur Dioxide'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}]",,0.114896,In this short-term study HFT appears feasible for patients with COPD exacerbation to reduce dyspnea score and improve respiratory distress.,"[{'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Rezaei', 'Affiliation': 'Chronic Respiratory Diseases Research Center (CRDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Fakharian', 'Affiliation': 'Chronic Respiratory Diseases Research Center (CRDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Ghorbani', 'Affiliation': 'Tracheal Diseases Research Center (TDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Esmaeil', 'Initials': 'E', 'LastName': 'Idani', 'Affiliation': 'Chronic Respiratory Diseases Research Center (CRDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Abedini', 'Affiliation': 'Chronic Respiratory Diseases Research Center (CRDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Jamaati', 'Affiliation': 'Chronic Respiratory Diseases Research Center (CRDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",The clinical respiratory journal,['10.1111/crj.13315'] 1585,33271192,A phase II randomized clinical trial of the safety and efficacy of intravenous umbilical cord blood infusion for treatment of children with autism spectrum disorder.,,2021,,['Children with Autism Spectrum Disorder'],['Intravenous Umbilical Cord Blood Infusion'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]",[],,0.0771643,,"[{'ForeName': 'Liem Thanh', 'Initials': 'LT', 'LastName': 'Nguyen', 'Affiliation': 'Vinmec Research Institute of Stem Cell and Gene Technology, Hanoi, Vietnam.'}, {'ForeName': 'Phuong Hoang', 'Initials': 'PH', 'LastName': 'Nguyen', 'Affiliation': 'Vinmec Research Institute of Stem Cell and Gene Technology, Hanoi, Vietnam.'}, {'ForeName': 'Duc Minh', 'Initials': 'DM', 'LastName': 'Hoang', 'Affiliation': 'Vinmec Research Institute of Stem Cell and Gene Technology, Hanoi, Vietnam.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.11.063'] 1586,33270911,"Efficacy and safety of chronomodulated irinotecan, oxaliplatin, 5-fluorouracil and leucovorin combination as first- or second-line treatment against metastatic colorectal cancer: Results from the International EORTC 05011 Trial.","The triplet combination of irinotecan, oxaliplatin and fluorouracil is an active frontline regimen in metastatic colorectal cancer, but scarce data exist on its use as salvage treatment. We aimed at assessing its safety and efficacy profiles with its circadian-based administration (chronoIFLO5) as either first- or second-line treatment, within the time-finding EORTC 05011 trial. Five-day chronoIFLO5 was administered every 3 weeks in patients with PS 0, 1 or 2. It consisted of chronomodulated irinotecan (180 mg/sqm), oxaliplatin (80 mg/sqm) and fluorouracil-leucovorin (2800 and 1200 mg/sqm, respectively). For our study, toxicity and antitumour activity were evaluated separately in first- and second-line settings. Primary endpoints included Grade 3-4 toxicity rates, best objective response rate (ORR), progression-free survival (PFS) and overall survival (OS). One-hundred forty-nine and 44 patients were treated in first-line and second-line settings, respectively, with a total of 1138 cycles with median relative dose intensities of about 90%. Demographics were comparable in the two groups. Thirty-six (24.7%) and 10 (22.2%) patients experienced at least one episode of severe toxicity in first line and second line, respectively. Frontline chronoIFLO5 yielded an ORR of 62.3% [95% CI: 54.2-70.4] and resulted in median PFS and OS of 8.7 months [7.5-9.9] and 19.9 months [15.4-24.5]. Corresponding figures in second line were 37.5% [22.5-52.5], 6.7 months [4.8-8.9] and 16.3 months [11.8-20.8]. International and prospective evaluation revealed the favourable safety and efficacy profiles of chronoIFLO5, both as frontline and as salvage treatment against metastatic colorectal cancer. In particular, encouraging activity in second line was observed, with limited haematological toxicity.",2020,Frontline chronoIFLO5 yielded an ORR of 62.3% [95% CI: 54.2-70.4] and resulted in median PFS and OS of 8.7 months [7.5-9.9] and 19.9 months [15.4-24.5].,['metastatic colorectal cancer'],"['circadian-based administration (chronoILFO5', 'oxaliplatin', 'fluorouracil-leucovorin', 'chronomodulated Irinotecan, Oxaliplatin, 5-Fluorouracil and Leucovorin combination', 'irinotecan, oxaliplatin and fluorouracil', 'chronomodulated irinotecan', 'chronoIFLO5']","['severe toxicity', 'grade 3-4 toxicity rates, best objective response rate (ORR), progression-free (PFS) and overall survival (OS', 'Efficacy and safety', 'toxicity and anti-tumour activity', 'median PFS and OS', 'haematological toxicity']","[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0463207,Frontline chronoIFLO5 yielded an ORR of 62.3% [95% CI: 54.2-70.4] and resulted in median PFS and OS of 8.7 months [7.5-9.9] and 19.9 months [15.4-24.5].,"[{'ForeName': 'Pasquale F', 'Initials': 'PF', 'LastName': 'Innominato', 'Affiliation': 'North Wales Cancer Centre, Ysbyty Gwynedd, Betsi Cadwaladr University Health Board, Bangor, UK.'}, {'ForeName': 'Abdoulaye', 'Initials': 'A', 'LastName': 'Karaboué', 'Affiliation': 'UPR ""Chronotherapy, Cancers and Transplantation"", Faculty of Medicine, Paris-Saclay University, Villejuif, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Focan', 'Affiliation': 'Department of Oncology, CHC-MontLegia, Groupe Santé CHC-Liège, Liège, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Chollet', 'Affiliation': 'Clinical and Translational Research Division, Jean Perrin Comprehensive Cancer Centre, Clermont-Ferrand, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Giacchetti', 'Affiliation': 'UPR ""Chronotherapy, Cancers and Transplantation"", Faculty of Medicine, Paris-Saclay University, Villejuif, France.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Bouchahda', 'Affiliation': 'UPR ""Chronotherapy, Cancers and Transplantation"", Faculty of Medicine, Paris-Saclay University, Villejuif, France.'}, {'ForeName': 'Ayhan', 'Initials': 'A', 'LastName': 'Ulusakarya', 'Affiliation': 'UPR ""Chronotherapy, Cancers and Transplantation"", Faculty of Medicine, Paris-Saclay University, Villejuif, France.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Torsello', 'Affiliation': 'Division of Medical Oncology, San Giovanni- Addolorata Hospital, Rome, Italy.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Adam', 'Affiliation': 'UPR ""Chronotherapy, Cancers and Transplantation"", Faculty of Medicine, Paris-Saclay University, Villejuif, France.'}, {'ForeName': 'Francis A', 'Initials': 'FA', 'LastName': 'Lévi', 'Affiliation': 'Cancer Chronotherapy Team, Cancer Research Centre, Division of Biomedical Sciences, Warwick Medical School, Coventry, UK.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Garufi', 'Affiliation': 'Division of Medical Oncology, San Camillo Forlanini Hospital, Rome, Italy.'}]",International journal of cancer,['10.1002/ijc.33422'] 1587,33789556,Limosilactobacillus reuteri ATCC PTA 5289 and DSM 17938 as adjuvants to improve evolution of pharyngitis/tonsillitis in children: randomised controlled trial.,"Pharyngitis and tonsillitis are the most common acute respiratory infections (ARIs) in children aged ≤5 years. The analysis of published data showed that some probiotics could decrease the frequency and number of days with ARIs. This study evaluated the safety and efficacy of Limosilactobacillus reuteri ATCC PTA 5289 and DSM 17938 to reduce the duration and severity of ARI symptoms. This randomised controlled trial included children aged from 6 months to 5 years, with pharyngitis or tonsillitis, who were randomised to receive a probiotic product containing L. reuteri ATCC PTA 5289 and L. reuteri DSM 17938 or placebo, as drops, ingested orally for 10 days as adjuvants to the use of non-steroidal anti-inflammatory drugs. The main outcomes were the duration and severity of ARI symptoms. The secondary outcomes were changes in salivary immunoglobulin A and inflammatory biomarkers. There was no fever on day 2 and subsequent days in the L. reuteri group (37.3 ±0.5 °C vs 38.6±0.3 °C, P <0.05). Beginning on day 3, the severity of sore throat (5±0.9 vs 8±1.2, P <0.05) was lower in the L. reuteri group. Significant differences in the days with runny nose, nasal congestion, days of non-programmed visits to the medical office or emergency department, levels in tumoral necrosis factor-alpha (TNF-alpha) and related costs of treatment were observed in the L. reuteri group. The frequency of adverse events was similar between the groups. Therefore, L. reuteri ATCC PTA 5289 combined with L. reuteri DSM 17938 is a safe and effective adjunct to reduce the symptoms of pharyngitis or tonsillitis in children.",2021,"Significant differences in the days with runny nose, nasal congestion, days of non-programmed visits to the medical office or emergency department, levels in tumoral necrosis factor-alpha (TNF-alpha) and related costs of treatment were observed in the L. reuteri group.","['children', 'children aged from 6 months to 5 years, with pharyngitis or tonsillitis', 'children aged ≤5 years']","['combined with L. reuteri', 'probiotic product containing L. reuteri ATCC PTA 5289 and L. reuteri DSM 17938 or placebo', 'DSM', 'ATCC PTA', 'Limosilactobacillus reuteri']","['symptoms of pharyngitis or tonsillitis', 'safety and efficacy', 'Pharyngitis and tonsillitis', 'frequency and number of days with ARIs', 'frequency of adverse events', 'days with runny nose, nasal congestion, days of non-programmed visits to the medical office or emergency department, levels in tumoral necrosis factor-alpha (TNF-alpha) and related costs of treatment', 'evolution of pharyngitis/tonsillitis', 'duration and severity of ARI symptoms', 'changes in salivary immunoglobulin A and inflammatory biomarkers', 'severity of sore throat']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001344', 'cui_str': 'Acute pharyngitis'}, {'cui': 'C0001361', 'cui_str': 'Acute tonsillitis'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0015522', 'cui_str': 'Coagulation factor XI'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001344', 'cui_str': 'Acute pharyngitis'}, {'cui': 'C0001361', 'cui_str': 'Acute tonsillitis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0238990', 'cui_str': 'Acute lower respiratory tract infection'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C1448177', 'cui_str': 'TNF protein, human'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0443735', 'cui_str': 'Salivary immunoglobulin A'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}]",,0.0939501,"Significant differences in the days with runny nose, nasal congestion, days of non-programmed visits to the medical office or emergency department, levels in tumoral necrosis factor-alpha (TNF-alpha) and related costs of treatment were observed in the L. reuteri group.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Maya-Barrios', 'Affiliation': ""Paediatric's Division, Hospital GEA, Calzada de Tlalpan 4800, 14080 Mexico City, Mexico.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Lira-Hernandez', 'Affiliation': 'Centre for Translational Research on Mother and Child Health, Hospital GEA, Calzada de Tlalpan 4800, 14080, Mexico City, Mexico.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Jiménez-Escobar', 'Affiliation': ""Paediatric's Division, Hospital GEA, Calzada de Tlalpan 4800, 14080 Mexico City, Mexico.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Hernández', 'Affiliation': ""Paediatric's Division, Hospital GEA, Calzada de Tlalpan 4800, 14080 Mexico City, Mexico.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ortiz-Hernandez', 'Affiliation': 'Emergency Department, Instituto Nacional de Pediatría, Insurgentes sur 3700-C, 04530 Mexico City, Mexico.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Jiménez-Gutiérrez', 'Affiliation': ""Paediatric's Division, Hospital GEA, Calzada de Tlalpan 4800, 14080 Mexico City, Mexico.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'López-Velázquez', 'Affiliation': 'Grupo de Investigación en Biomoléculas y Salud Infantil, Lab. EIMyT, Instituto Nacional de Pediatría, Insurgentes sur 3700-C, 04530 Mexico City, Mexico.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Gutiérrez-Castrellón', 'Affiliation': 'Centre for Translational Research on Mother and Child Health, Hospital GEA, Calzada de Tlalpan 4800, 14080, Mexico City, Mexico.'}]",Beneficial microbes,['10.3920/BM2020.0171'] 1588,33277338,Baseline Assessment of Circulating MicroRNAs Near Diagnosis of Type 1 Diabetes Predicts Future Stimulated Insulin Secretion.,"Type 1 diabetes is an autoimmune disease resulting in severely impaired insulin secretion. We investigated whether circulating microRNAs (miRNAs) are associated with residual insulin secretion at diagnosis and predict the severity of its future decline. We studied 53 newly diagnosed subjects enrolled in placebo groups of TrialNet clinical trials. We measured serum levels of 2,083 miRNAs, using RNA sequencing technology, in fasting samples from the baseline visit (<100 days from diagnosis), during which residual insulin secretion was measured with a mixed meal tolerance test (MMTT). Area under the curve (AUC) C-peptide and peak C-peptide were stratified by quartiles of expression of 31 miRNAs. After adjustment for baseline C-peptide, age, BMI, and sex, baseline levels of miR-3187-3p, miR-4302, and the miRNA combination of miR-3187-3p/miR-103a-3p predicted differences in MMTT C-peptide AUC/peak levels at the 12-month visit; the combination miR-3187-3p/miR-4723-5p predicted proportions of subjects above/below the 200 pmol/L clinical trial eligibility threshold at the 12-month visit. Thus, miRNA assessment at baseline identifies associations with C-peptide and stratifies subjects for future severity of C-peptide loss after 1 year. We suggest that miRNAs may be useful in predicting future C-peptide decline for improved subject stratification in clinical trials.",2021,"After adjustment for baseline C-peptide, age, BMI and sex, baseline levels of miR-3187-3p, miR-4302, and the miRNA combination of miR-3187-3p/miR-103a-3p predicted differences in MMTT C-peptide AUC/peak levels at the 12-month visit; the combination miR-3187-3p/miR-4723-5p predicted proportions of subjects above/below the 200 pmol/L clinical trial eligibility threshold at the 12-month visit.",['53 newly diagnosed subjects enrolled in placebo groups of TrialNet clinical trials'],[],"['Area under the curve (AUC) C-peptide and peak C-peptide', 'Baseline Assessment of Circulating microRNAs']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4055233', 'cui_str': 'Cell-Free MicroRNA'}]",53.0,0.190259,"After adjustment for baseline C-peptide, age, BMI and sex, baseline levels of miR-3187-3p, miR-4302, and the miRNA combination of miR-3187-3p/miR-103a-3p predicted differences in MMTT C-peptide AUC/peak levels at the 12-month visit; the combination miR-3187-3p/miR-4723-5p predicted proportions of subjects above/below the 200 pmol/L clinical trial eligibility threshold at the 12-month visit.","[{'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Snowhite', 'Affiliation': 'Diabetes Research Institute, Leonard M. Miller School of Medicine, University of Miami, Miami, FL.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Pastori', 'Affiliation': 'Diabetes Research Institute, Leonard M. Miller School of Medicine, University of Miami, Miami, FL.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Sosenko', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Leonard M. Miller School of Medicine, University of Miami, Miami, FL.'}, {'ForeName': 'Shari', 'Initials': 'S', 'LastName': 'Messinger Cayetano', 'Affiliation': 'Department of Public Health Sciences, Leonard M. Miller School of Medicine, University of Miami, Miami, FL.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Pugliese', 'Affiliation': 'Diabetes Research Institute, Leonard M. Miller School of Medicine, University of Miami, Miami, FL apuglies@med.miami.edu.'}]",Diabetes,['10.2337/db20-0817'] 1589,33789482,Neither operative nor nonoperative approach is superior for treating displaced midshaft clavicle fractures: a partially blinded randomized controlled clinical trial.,"AIMS To compare the functionality of adults with displaced mid-shaft clavicular fractures treated either operatively or nonoperatively and to compare the relative risk of nonunion and reoperation between the two groups. METHODS Based on specific eligibility criteria, 120 adults (median age 37.5 years (interquartile range (18 to 61)) and 84% males (n = 101)) diagnosed with an acute displaced mid-shaft fracture were recruited, and randomized to either the operative (n = 60) or nonoperative (n = 60) treatment group. This randomized controlled, partially blinded trial followed patients for 12 months following initial treatment. Functionality was assessed by the Constant score (CS) (assessor blinded to treatment) and Disability of the Arm, Shoulder and Hand (DASH) score. Clinical and radiological evaluation, and review of patient files for complications and reoperations, were added as secondary outcomes. RESULTS At 12 months, 87.5% of patients (n = 105) were available for analysis. The two groups were well balanced based on demographic and fracture-related characteristics. At six weeks of follow-up a significant difference in DASH score (p < 0.001) was found in favour of operative treatment. The functionality at 12 months of follow-up based on CS and DASH was excellent in both groups (CS > 90 points and DASH < 10 points) with no significant difference (p = 0.277 for DASH and p = 0.184 for CS) between the two groups. The risk of symptomatic nonunion was significantly higher in the nonoperative group (p = 0.014), with a relative risk of 9.47 (95% confidence interval (CI) 1.26 to 71.53) in this group compared to the operative group. The number-needed-to-treat to avoid one symptomatic nonunion was 6.2. Initial treatment and age were factors significantly associated with nonunion in a logistic analysis. There were 26% in both groups (n = 14 in operative group and n = 15 in nonoperative group) who required secondary surgery, with most indications in the nonoperative group mandatory due to nonunion compared to most relative indications in the operative group requiring intervention due to implant irritation. CONCLUSION Superiority was not identified with either an all-operative or all-nonoperative approach. The functionality at short term (within six weeks) seems igreater following operative treatment but was not found at one year. The risk of nonunion is significantly higher with nonoperative treatment. However, an all-operative approach to lower the nonunion risk may result in unnecessary surgery and is not recommended. Cite this article: Bone Joint J  2021;103-B(4):762-768.",2021,At six weeks of follow-up a significant difference in DASH score (p < 0.001) was found in favour of operative treatment.,"['Based on specific eligibility criteria, 120 adults (median age 37.5 years (interquartile range (18 to 61)) and 84% males (n = 101)) diagnosed with an acute displaced mid-shaft fracture', 'adults with displaced mid-shaft clavicular fractures', 'displaced midshaft clavicle fractures']",[],"['risk of symptomatic nonunion', 'Constant score (CS) (assessor blinded to treatment) and Disability of the Arm, Shoulder and Hand (DASH) score', 'risk of nonunion', 'DASH score']","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517742', 'cui_str': '37.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0337141', 'cui_str': 'Shaft'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0159658', 'cui_str': 'Fracture of clavicle'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]",105.0,0.230286,At six weeks of follow-up a significant difference in DASH score (p < 0.001) was found in favour of operative treatment.,"[{'ForeName': 'Ilija', 'Initials': 'I', 'LastName': 'Ban', 'Affiliation': 'Department of Orthopaedic Surgery, Clinical Orthopaedic Research Hvidovre, Copenhagen University Hospital Amager and Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Morten Tange', 'Initials': 'MT', 'LastName': 'Kristensen', 'Affiliation': 'Physical Medicine and Rehabilitation Research - Copenhagen, Departments of Physiotherapy and Orthopaedic Surgery, Copenhagen University Hospital Amager and Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Kristoffer Weisskirchner', 'Initials': 'KW', 'LastName': 'Barfod', 'Affiliation': 'Department of Orthopeadic Surgery, Amager and Hvidovre, Sports Orthopeadic Research Center - Copenhagen, Copenhagen University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Eschen', 'Affiliation': 'Department of Orthopaedic Surgery, Copenhagen University Hospital Herlev and Gentofte, Borgmeste, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kallemose', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital, Amager and Hvidovre, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Troelsen', 'Affiliation': 'Department of Orthopaedic Surgery, Clinical Orthopaedic Research Hvidovre, Copenhagen University Hospital Amager and Hvidovre, Hvidovre, Denmark.'}]",The bone & joint journal,['10.1302/0301-620X.103B4.BJJ-2020-1636.R1'] 1590,33282192,Effect of riociguat on pulmonary arterial compliance in the PATENT and CHEST studies.,"Pulmonary arterial compliance is a measure of the pulsatile afterload of the right ventricle. Lower pulmonary arterial compliance is associated with reduced right ventricular function and worse prognosis in pulmonary hypertension. The effect of pulmonary vasodilators on pulmonary arterial compliance has not been evaluated in detail in pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension. In this post hoc analysis of patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension in the PATENT and CHEST studies, we evaluated the change in pulmonary arterial compliance with riociguat versus placebo. Association of pulmonary arterial compliance with clinical outcomes was assessed using Kaplan-Meier and Cox proportional hazards analyses. Compared with placebo, riociguat significantly improved pulmonary arterial compliance in patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension. Pulmonary arterial compliance at baseline was associated with survival and clinical worsening-free survival in pulmonary arterial hypertension but only with clinical worsening-free survival in chronic thromboembolic pulmonary hypertension. In patients with pulmonary arterial hypertension, pulmonary arterial compliance at follow-up ≥1.6 mL/mmHg was associated with better outcomes than pulmonary arterial compliance <1.6 mL/mmHg. In patients with chronic thromboembolic pulmonary hypertension, pulmonary arterial compliance at follow-up did not predict outcomes. Cox proportional hazards analyses showed no association between change in pulmonary arterial compliance and outcomes in patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension. In conclusion, riociguat improved pulmonary arterial compliance in patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension. Pulmonary arterial compliance at baseline or follow-up, rather than change in pulmonary arterial compliance, is of prognostic importance for outcomes.",2020,"Compared with placebo, riociguat significantly improved pulmonary arterial compliance in patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension.","['pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension', 'patients with pulmonary arterial hypertension', 'patients with chronic thromboembolic pulmonary hypertension', 'patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension', 'patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension']","['placebo, riociguat', 'pulmonary vasodilators', 'placebo', 'riociguat']","['survival and clinical worsening-free survival', 'Pulmonary arterial compliance', 'pulmonary arterial compliance', 'pulmonary arterial compliance and outcomes']","[{'cui': 'C2973725', 'cui_str': 'Pulmonary arterial hypertension'}, {'cui': 'C2363973', 'cui_str': 'Chronic thromboembolic pulmonary hypertension'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2717561', 'cui_str': 'riociguat'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0042402', 'cui_str': 'Vasodilator agent'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0287879,"Compared with placebo, riociguat significantly improved pulmonary arterial compliance in patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension.","[{'ForeName': 'Thenappan', 'Initials': 'T', 'LastName': 'Thenappan', 'Affiliation': 'Division of Cardiology, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Al-Naamani', 'Affiliation': 'Pulmonary, Critical Care and Sleep Division, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Ghio', 'Affiliation': 'Division of Cardiology, Fondazione IRCCS Policlinico San Matteo, University Hospital, Pavia, Italy.'}, {'ForeName': 'Hossein-Ardeschir', 'Initials': 'HA', 'LastName': 'Ghofrani', 'Affiliation': 'Department of Medicine, University of Giessen and Marburg Lung Center (UGMLC), Giessen, Germany.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Hassoun', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Pritzker', 'Affiliation': 'Division of Cardiology, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Torbicki', 'Affiliation': 'Department of Pulmonary Circulation and Thromboembolic Diseases, Center of Postgraduate Medical Education, ECZ-Otwock, Otwock, Poland.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Nikkho', 'Affiliation': 'Global Clinical Development, Bayer AG, Berlin, Germany.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Busse', 'Affiliation': 'Chrestos Concept GmbH & Co. KG, Essen, Germany.'}, {'ForeName': 'Ioana R', 'Initials': 'IR', 'LastName': 'Preston', 'Affiliation': 'Pulmonary, Critical Care and Sleep Division, Tufts University Medical Center, Boston, MA, USA.'}]",Pulmonary circulation,['10.1177/2045894020963836'] 1591,33283767,To study impact of treatment with Rosuvastatin versus Atorvastatin on 25 hydroxy Vitamin D concentrations among adult Indian men- a randomized control trial.,"BACKGROUND Dyslipidemias are on the rise and are increasingly being treated with statins. As the metabolism of cholecalciferol and cholesterol are interrelated, reduction in cholesterol synthesis by statins is likely to affect Vitamin D status. OBJECTIVES (1) The aim is to study the effect of treatment with statins (Atorvastatin/Rosuvastatin) on 25-hydroxy-Vitamin-D (25OHD) among newly detected subjects with dyslipidemia for 6 months (2) To study the impact of 25OHD concentrations on the efficacy of statin treatment. MATERIALS AND METHODS This was a prospective, balanced randomized (1:1), open-label, parallel-group study, in apparently healthy Indian adult men (south Asian, 40-60 years). At baseline, serum lipids and 25OHD concentrations were measured. Based on the Adult Treatment Panel III guidelines, subjects were divided as per lipid concentrations into controls (who did not require statin treatment) and intervention (who required statin treatment) groups. Random allocation of subjects was done in two groups for receiving intervention for 6 months: Atorvastatin group (n = 52, received Atorvastatin) or Rosuvastatin group (n = 52, received Rosuvastatin). Lipids and 25OHD concentrations were measured at the end line. RESULTS Atorvastatin group presented significant reduction (P < 0.05) in 25OHD, total cholesterol (TC) and low-density-lipoprotein-cholesterol (LDL-C) concentrations at the end line. In the Rosuvastatin group, significant drop in TC, LDL-C and high-density lipoprotein cholesterol (concentrations (P < 0.05) was observed, while 25OHD concentrations showed no significant change. Mean 25OHD concentrations were significantly correlated with a reduction in LDL-C concentrations in Atorvastatin group. CONCLUSIONS Treatment with Atorvastatin resulted in a reduction in 25OHD concentrations; further, its efficacy in reducing LDL-C concentrations was related to the 25OHD concentrations.",2020,"RESULTS Atorvastatin group presented significant reduction (P < 0.05) in 25OHD, total cholesterol (TC) and low-density-lipoprotein-cholesterol (LDL-C) concentrations at the end line.","['25 hydroxy Vitamin D concentrations among adult Indian men', 'apparently healthy Indian adult men (south Asian, 40-60 years', 'newly detected subjects with dyslipidemia for 6 months (2']","['Atorvastatin) or Rosuvastatin', 'Atorvastatin', 'Rosuvastatin versus Atorvastatin', 'statins (Atorvastatin/Rosuvastatin', 'Rosuvastatin']","['Mean 25OHD concentrations', 'Lipids and 25OHD concentrations', 'TC, LDL-C and high-density lipoprotein cholesterol (concentrations', '25OHD concentrations', 'serum lipids and 25OHD concentrations', 'LDL-C concentrations', '25OHD, total cholesterol (TC) and low-density-lipoprotein-cholesterol (LDL-C) concentrations', '25-hydroxy-Vitamin-D (25OHD']","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]",,0.0150196,"RESULTS Atorvastatin group presented significant reduction (P < 0.05) in 25OHD, total cholesterol (TC) and low-density-lipoprotein-cholesterol (LDL-C) concentrations at the end line.","[{'ForeName': 'Vivek G', 'Initials': 'VG', 'LastName': 'Patwardhan', 'Affiliation': 'Department of Pediatric Growth and Endocrine Unit, Hirabai Cowasji Jehangir Medical Research Institute, Jehangir Hospital, Pune, Maharashtra, India.'}, {'ForeName': 'Zulf M', 'Initials': 'ZM', 'LastName': 'Mughal', 'Affiliation': ""Department of Paediatric Endocrinology, Royal Manchester Children's Hospital, Manchester, UK.""}, {'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'Padidela', 'Affiliation': ""Department of Paediatric Endocrinology, Royal Manchester Children's Hospital, Manchester, UK.""}, {'ForeName': 'Shashi A', 'Initials': 'SA', 'LastName': 'Chiplonkar', 'Affiliation': 'Department of Pediatric Growth and Endocrine Unit, Hirabai Cowasji Jehangir Medical Research Institute, Jehangir Hospital, Pune, Maharashtra, India.'}, {'ForeName': 'Vaman V', 'Initials': 'VV', 'LastName': 'Khadilkar', 'Affiliation': 'Department of Pediatric Growth and Endocrine Unit, Hirabai Cowasji Jehangir Medical Research Institute, Jehangir Hospital, Pune, Maharashtra, India.'}, {'ForeName': 'Anuradha V', 'Initials': 'AV', 'LastName': 'Khadilkar', 'Affiliation': 'Department of Pediatric Growth and Endocrine Unit, Hirabai Cowasji Jehangir Medical Research Institute, Jehangir Hospital, Pune, Maharashtra, India.'}]",Indian journal of pharmacology,['10.4103/ijp.IJP_93_18'] 1592,33063862,"Efficacy of Galcanezumab for Migraine Prevention in Patients With a Medical History of Anxiety and/or Depression: A Post Hoc Analysis of the Phase 3, Randomized, Double-Blind, Placebo-Controlled REGAIN, and Pooled EVOLVE-1 and EVOLVE-2 Studies.","OBJECTIVE This post hoc analysis evaluated the efficacy of galcanezumab for the prevention of migraine in patients with and without comorbid anxiety and/or depression. BACKGROUND Patients with migraine have a higher risk of anxiety and/or depression. Given the high prevalence of psychiatric symptoms and their potential negative prognostic impact, determining the efficacy of migraine treatments in patients with these comorbidities is important. METHODS The results of 2 phase 3 episodic migraine studies of patients with 4-14 migraine headache days (MHD) per month were pooled. A third chronic migraine study, which was evaluated separately, enrolled patients with ≥15 headache days per month, of which ≥8 had migraine-like features. Patients in all 3 studies were randomized 2:1:1 to placebo, galcanezumab 120 mg, or galcanezumab 240 mg. The efficacy of galcanezumab on migraine was measured in subgroups of patients with anxiety and/or depression (current or past) and patients without. A repeated measures model was used to compare treatment groups within each subgroup and to test for consistency of treatment effect across the anxiety/depression subgroups (subgroup-by-treatment interaction) during the double-blind treatment phases. RESULTS Among 1773 intent-to-treat patients with episodic migraine, both doses of galcanezumab demonstrated statistically significant improvements relative to placebo in overall number of MHD for the subgroups of patients with anxiety and/or depression (mean change difference from placebo [95% CI]: -2.07 [-2.81, -1.33] for galcanezumab 120 mg [P < .001], -1.91 [-2.78, -1.04] for 240 mg [P < .001]) and without anxiety and/or depression (mean change difference from placebo [95% CI]: -1.92 [-2.36, -1.47] for 120 mg [P < .001], -1.77 [-2.20, -1.33] for 240 mg [P < .001]), as was observed for the secondary outcomes of MHD with acute medication use and functional impairment. Among 1113 intent-to-treat patients with chronic migraine, those with anxiety and/or depression had significant reductions in overall MHD frequency with the 240-mg dose (mean change difference from placebo [95% CI]: -1.92 [-3.52, -0.33]; P = .018), whereas significant reductions were observed at both the 120-mg (mean change difference from placebo [95% CI]: -2.29 [-3.26, -1.31]; P < .001) and 240-mg (-1.85 [-2.83, -0.87]; P < .001) doses in patients without anxiety and/or depressions. Significant reductions (P < .01) in MHD with acute medication use were observed at both doses within both anxiety/depression subgroups and for overall functional impairment for patients without anxiety and/or depression, though neither dose significantly reduced overall functional impairment beyond placebo in the subgroup with anxiety and/or depression. In the episodic and chronic migraine studies, the subgroup-by-treatment interaction was not statistically significant for MHD, MHD with acute medication use, or functional impairment (chronic study only), suggesting a lack of evidence of differential effect between subgroups. Furthermore, differences between subgroups in the mean change differences from placebo, as well as overlapping 95% confidence intervals for the subgroups, indicated lack of a clinical or statistical difference between subgroups for these outcome variables. There was a significantly higher percentage of patients with episodic migraine attaining ≥50%, ≥75%, and 100% reductions, and a higher percentage of patients with chronic migraine attaining ≥50% and ≥75% reductions from baseline with galcanezumab compared with placebo, regardless of medical history of anxiety and/or depression. CONCLUSIONS A medical history of anxiety and/or depression does not seem to interfere with response to galcanezumab among patients with episodic migraine, and both doses of galcanezumab appear efficacious for these individuals regardless of this psychiatric history. Among patients with chronic migraine and comorbid anxiety and/or depression, the 240-mg dose, but not the 120-mg dose, significantly decreased overall MHD, but neither dose resulted in significantly greater functional improvement. Patients with migraine and comorbid anxiety and/or depression often require additional interventions, and this may be more important in chronic migraine.",2020,"Significant reductions (P < .01) in MHD with acute medication use were observed at both doses within both anxiety/depression subgroups and for overall functional impairment for patients without anxiety and/or depression, though neither dose significantly reduced overall functional impairment beyond placebo in the subgroup with anxiety and/or depression.","['enrolled patients with ≥15 headache days per month, of which ≥8 had migraine-like features', 'Patients With a Medical History of Anxiety', 'subgroups of patients with anxiety and/or depression (current or past) and patients without', 'patients with these comorbidities is important', 'Patients with migraine and comorbid anxiety and/or depression often require additional interventions', 'and/or Depression', 'patients with episodic migraine', 'patients with 4-14 migraine headache days (MHD) per month were pooled', 'patients with and without comorbid anxiety and/or depression']","['Galcanezumab', 'galcanezumab', 'placebo', 'placebo, galcanezumab 120\xa0mg, or galcanezumab 240\xa0mg', 'Placebo']","['chronic migraine', 'MHD with acute medication use and functional impairment', 'comorbid anxiety and/or depression', 'migraine', 'anxiety and/or depression', 'overall MHD', 'overall functional impairment', 'functional improvement', 'overall number of MHD', 'episodic migraine', 'overall MHD frequency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0556971', 'cui_str': 'days/month'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1444635', 'cui_str': 'Current or past'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0337051', 'cui_str': 'Pool'}]","[{'cui': 'C4694273', 'cui_str': 'galcanezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319600', 'cui_str': '240'}]","[{'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",,0.162567,"Significant reductions (P < .01) in MHD with acute medication use were observed at both doses within both anxiety/depression subgroups and for overall functional impairment for patients without anxiety and/or depression, though neither dose significantly reduced overall functional impairment beyond placebo in the subgroup with anxiety and/or depression.","[{'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Smitherman', 'Affiliation': 'Department of Psychology, The University of Mississippi, University, MS, USA.'}, {'ForeName': 'Gretchen E', 'Initials': 'GE', 'LastName': 'Tietjen', 'Affiliation': 'Department of Neurology, University of Toledo, Toledo, OH, USA.'}, {'ForeName': 'Kory', 'Initials': 'K', 'LastName': 'Schuh', 'Affiliation': 'Medical Affairs, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Skljarevski', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lipsius', 'Affiliation': 'Department of Statistics, Syneos Health, Raleigh, NC, USA.'}, {'ForeName': 'Deborah N', 'Initials': 'DN', 'LastName': ""D'Souza"", 'Affiliation': 'Clinical Solutions, Syneos Health, Raleigh, NC, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Pearlman', 'Affiliation': 'Medical Affairs, Eli Lilly and Company, Indianapolis, IN, USA.'}]",Headache,['10.1111/head.13970'] 1593,33063909,Long-term survival of participants in the CENTAUR trial of sodium phenylbutyrate-taurursodiol in amyotrophic lateral sclerosis.,"An orally administered, fixed-dose coformulation of sodium phenylbutyrate-taurursodiol (PB-TURSO) significantly slowed functional decline in a randomized, placebo-controlled, phase 2 trial in ALS (CENTAUR). Herein we report results of a long-term survival analysis of participants in CENTAUR. In CENTAUR, adults with ALS were randomized 2:1 to PB-TURSO or placebo. Participants completing the 6-month (24-week) randomized phase were eligible to receive PB-TURSO in the open-label extension. An all-cause mortality analysis (35-month maximum follow-up post-randomization) incorporated all randomized participants. Participants and site investigators were blinded to treatment assignments through the duration of follow-up of this analysis. Vital status was obtained for 135 of 137 participants originally randomized in CENTAUR. Median overall survival was 25.0 months among participants originally randomized to PB-TURSO and 18.5 months among those originally randomized to placebo (hazard ratio, 0.56; 95% confidence interval, 0.34-0.92; P = .023). Initiation of PB-TURSO treatment at baseline resulted in a 6.5-month longer median survival as compared with placebo. Combined with results from CENTAUR, these results suggest that PB-TURSO has both functional and survival benefits in ALS.",2021,"Median overall survival was 25.0 months among participants originally randomized to PB-TURSO and 18.5 months among those originally randomized to placebo (hazard ratio, 0.56; 95% CI, 0.34-0.92; P=0.023). ","['adults with ALS', '135 of 137 participants originally randomized in CENTAUR', 'participants in CENTAUR']","['sodium phenylbutyrate-taurursodiol (PB-TURSO', 'placebo', 'PB-TURSO in the open-label extension (OLE']","['Median overall survival', 'median survival']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C4517569', 'cui_str': '137'}]","[{'cui': 'C0718066', 'cui_str': 'sodium phenylbutyrate'}, {'cui': 'C0031465', 'cui_str': 'Phenylbutyrates'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",137.0,0.647067,"Median overall survival was 25.0 months among participants originally randomized to PB-TURSO and 18.5 months among those originally randomized to placebo (hazard ratio, 0.56; 95% CI, 0.34-0.92; P=0.023). ","[{'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Paganoni', 'Affiliation': 'Sean M. Healey & AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Hendrix', 'Affiliation': 'Pentara Corporation, Millcreek, Utah.'}, {'ForeName': 'Samuel P', 'Initials': 'SP', 'LastName': 'Dickson', 'Affiliation': 'Pentara Corporation, Millcreek, Utah.'}, {'ForeName': 'Newman', 'Initials': 'N', 'LastName': 'Knowlton', 'Affiliation': 'Pentara Corporation, Millcreek, Utah.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Macklin', 'Affiliation': 'Department of Medicine, Biostatistics Center, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Berry', 'Affiliation': 'Sean M. Healey & AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Elliott', 'Affiliation': 'Swedish Neuroscience Institute, Seattle, Washington.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Maiser', 'Affiliation': 'Departments of Neurology and Medicine, Hennepin Healthcare, Minneapolis, Minnesota.'}, {'ForeName': 'Chafic', 'Initials': 'C', 'LastName': 'Karam', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Caress', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Margaret Ayo', 'Initials': 'MA', 'LastName': 'Owegi', 'Affiliation': 'Department of Neurology, University of Massachusetts Memorial Medical Center, Worcester, Massachusetts.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Quick', 'Affiliation': 'Department of Neurology, The Ohio State University College of Medicine, Columbus, Ohio.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wymer', 'Affiliation': 'Department of Neurology, University of Florida College of Medicine, Gainesville, Florida.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Goutman', 'Affiliation': 'Department of Neurology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Daragh', 'Initials': 'D', 'LastName': 'Heitzman', 'Affiliation': 'Texas Neurology, Dallas, Texas.'}, {'ForeName': 'Terry D', 'Initials': 'TD', 'LastName': 'Heiman-Patterson', 'Affiliation': 'Department of Neurology, Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Carlayne E', 'Initials': 'CE', 'LastName': 'Jackson', 'Affiliation': 'Department of Neurology, The University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Quinn', 'Affiliation': 'Department of Neurology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Rothstein', 'Affiliation': 'Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Kasarskis', 'Affiliation': 'Department of Neurology, University of Kentucky College of Medicine, Lexington, Kentucky.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Katz', 'Affiliation': 'California Pacific Medical Center Research Institute and Forbes Norris MDA/ALS Research and Treatment Center, San Francisco, California.'}, {'ForeName': 'Liberty', 'Initials': 'L', 'LastName': 'Jenkins', 'Affiliation': 'California Pacific Medical Center Research Institute and Forbes Norris MDA/ALS Research and Treatment Center, San Francisco, California.'}, {'ForeName': 'Shafeeq', 'Initials': 'S', 'LastName': 'Ladha', 'Affiliation': 'Department of Neurology, Gregory W. Fulton ALS Center, Barrow Neurological Institute, Phoenix, Arizona.'}, {'ForeName': 'Timothy M', 'Initials': 'TM', 'LastName': 'Miller', 'Affiliation': 'Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Stephen N', 'Initials': 'SN', 'LastName': 'Scelsa', 'Affiliation': 'Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Tuan H', 'Initials': 'TH', 'LastName': 'Vu', 'Affiliation': 'Department of Neurology, University of South Florida Morsani College of Medicine, Tampa, Florida.'}, {'ForeName': 'Christina N', 'Initials': 'CN', 'LastName': 'Fournier', 'Affiliation': 'Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Glass', 'Affiliation': 'Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Johnson', 'Affiliation': 'Department of Neurology, Ochsner Health System, New Orleans, Louisiana.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Swenson', 'Affiliation': 'Department of Neurology, University of Iowa Carver College of Medicine, Iowa City, Iowa.'}, {'ForeName': 'Namita A', 'Initials': 'NA', 'LastName': 'Goyal', 'Affiliation': 'Department of Neurology, University of California, Irvine School of Medicine, Irvine, California.'}, {'ForeName': 'Gary L', 'Initials': 'GL', 'LastName': 'Pattee', 'Affiliation': 'Neurology Associates, Lincoln, Nebraska.'}, {'ForeName': 'Patricia L', 'Initials': 'PL', 'LastName': 'Andres', 'Affiliation': 'Independent Consultant, Nobleboro, Maine.'}, {'ForeName': 'Suma', 'Initials': 'S', 'LastName': 'Babu', 'Affiliation': 'Sean M. Healey & AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Chase', 'Affiliation': 'Sean M. Healey & AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Dagostino', 'Affiliation': 'Sean M. Healey & AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'Department of Neurology, Gregory W. Fulton ALS Center, Barrow Neurological Institute, Phoenix, Arizona.'}, {'ForeName': 'Gale', 'Initials': 'G', 'LastName': 'Kittle', 'Affiliation': 'Department of Neurology, Gregory W. Fulton ALS Center, Barrow Neurological Institute, Phoenix, Arizona.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Eydinov', 'Affiliation': 'Sean M. Healey & AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'McGovern', 'Affiliation': 'Sean M. Healey & AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Ostrow', 'Affiliation': 'Sean M. Healey & AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Pothier', 'Affiliation': 'Sean M. Healey & AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Randall', 'Affiliation': 'Department of Neurology, Gregory W. Fulton ALS Center, Barrow Neurological Institute, Phoenix, Arizona.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Shefner', 'Affiliation': 'Department of Neurology, Gregory W. Fulton ALS Center, Barrow Neurological Institute, Phoenix, Arizona.'}, {'ForeName': 'Alexander V', 'Initials': 'AV', 'LastName': 'Sherman', 'Affiliation': 'Sean M. Healey & AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'St Pierre', 'Affiliation': 'Sean M. Healey & AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Tustison', 'Affiliation': 'Sean M. Healey & AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Prasha', 'Initials': 'P', 'LastName': 'Vigneswaran', 'Affiliation': 'Sean M. Healey & AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Walker', 'Affiliation': 'Sean M. Healey & AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Sean M. Healey & AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine, Biostatistics Center, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Wittes', 'Affiliation': 'Statistics Collaborative, Inc., Washington, District of Columbia.'}, {'ForeName': 'Zi-Fan', 'Initials': 'ZF', 'LastName': 'Yu', 'Affiliation': 'Statistics Collaborative, Inc., Washington, District of Columbia.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Cohen', 'Affiliation': 'Amylyx Pharmaceuticals, Inc., Cambridge, Massachusetts.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Klee', 'Affiliation': 'Amylyx Pharmaceuticals, Inc., Cambridge, Massachusetts.'}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Leslie', 'Affiliation': 'Amylyx Pharmaceuticals, Inc., Cambridge, Massachusetts.'}, {'ForeName': 'Rudolph E', 'Initials': 'RE', 'LastName': 'Tanzi', 'Affiliation': 'Sean M. Healey & AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Gilbert', 'Affiliation': 'Harvard University, Cambridge, Massachusetts.'}, {'ForeName': 'Patrick D', 'Initials': 'PD', 'LastName': 'Yeramian', 'Affiliation': 'Amylyx Pharmaceuticals, Inc., Cambridge, Massachusetts.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schoenfeld', 'Affiliation': 'Department of Medicine, Biostatistics Center, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Merit E', 'Initials': 'ME', 'LastName': 'Cudkowicz', 'Affiliation': 'Sean M. Healey & AMG Center for ALS & the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}]",Muscle & nerve,['10.1002/mus.27091'] 1594,33060547,Central and Peripheral Postexercise Blood Pressure and Vascular Responses in Young Adults with Obesity.,"INTRODUCTION Adults with obesity are at an increased risk of incident hypertension. Regular aerobic exercise is recommended for the prevention and treatment of hypertension, but whether young adults with obesity exhibit impaired postexercise blood pressure (BP) and vascular responses remains unclear. PURPOSE We tested the hypothesis that young adults with obesity exhibit attenuated postexercise hypotension (PEH) and postexercise peripheral vasodilation compared with young adults without obesity. METHODS Thirty-six normotensive adults without and with obesity (11 men and 7 women per group) underwent measurements of brachial and central BP, and leg blood flow (Doppler ultrasound) at baseline and at 30, 60, and 90 min after acute 1-h moderate-intensity cycling. Leg vascular conductance (LVC) was calculated as flow/mean arterial pressure. RESULTS Both groups exhibited similar brachial and central PEH (peak change from baseline, -2 and -4 mm Hg for brachial and central systolic BPs, respectively, for both groups; time effect, P < 0.05). Both groups also exhibited postexercise peripheral vasodilation, assessed via LVC (time effect, P < 0.05), but its overall magnitude was smaller in young adults with obesity (LVC change from baseline, +47% ± 37%, +29% ± 36%, and +20% ± 29%) compared with young adults without obesity (LVC change from baseline, +88% ± 58%, +59% ± 54%, and +42% ± 51%; group effect, P < 0.05). CONCLUSIONS Although obesity did not impair PEH after acute moderate-intensity exercise, young adults with obesity exhibited smaller postexercise peripheral vasodilation compared with young adults without obesity. Collectively, these findings have identified evidence for obesity-induced alterations in the peripheral vasculature after exercise.",2021,"Both groups also exhibited post-exercise peripheral vasodilation, assessed via LVC (time effect: p<0.05), but its overall magnitude was smaller in young adults with obesity (LVC change from baseline: +47 ± 37%, +29 ± 36%, and +20 ± 29%) compared with young adults without obesity (LVC change from baseline: +88 ± 58%, +59 ± 54%, and +42 ± 51%) (group effect: p<0.05). ","['Young Adults with Obesity', 'Thirty-six normotensive adults without and with obesity (11 males and 7 females per group', 'young adults with obesity exhibit attenuated post']","['exercise hypotension (PEH) and post-exercise peripheral vasodilation', 'Regular aerobic exercise']","['brachial and central PEH', 'Central and Peripheral Postexercise Blood Pressure and Vascular Responses', 'brachial and central BP, and leg blood flow (Doppler ultrasound', 'Leg vascular conductance (LVC', 'flow/mean arterial pressure (MAP']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C2936233', 'cui_str': 'Post Exercise Hypotension'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C2936233', 'cui_str': 'Post Exercise Hypotension'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0162481', 'cui_str': 'Doppler ultrasound'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",36.0,0.170612,"Both groups also exhibited post-exercise peripheral vasodilation, assessed via LVC (time effect: p<0.05), but its overall magnitude was smaller in young adults with obesity (LVC change from baseline: +47 ± 37%, +29 ± 36%, and +20 ± 29%) compared with young adults without obesity (LVC change from baseline: +88 ± 58%, +59 ± 54%, and +42 ± 51%) (group effect: p<0.05). ","[{'ForeName': 'Kanokwan', 'Initials': 'K', 'LastName': 'Bunsawat', 'Affiliation': ''}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Lefferts', 'Affiliation': 'Integrative Physiology Laboratory, Department of Kinesiology and Nutrition, College of Applied Health Sciences, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Grigoriadis', 'Affiliation': 'Integrative Physiology Laboratory, Department of Kinesiology and Nutrition, College of Applied Health Sciences, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Sang Ouk', 'Initials': 'SO', 'LastName': 'Wee', 'Affiliation': ''}, {'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Kilianek', 'Affiliation': 'Integrative Physiology Laboratory, Department of Kinesiology and Nutrition, College of Applied Health Sciences, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Fadel', 'Affiliation': 'Department of Kinesiology, College of Nursing and Health Innovation, University of Texas at Arlington, Arlington, TX.'}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Clifford', 'Affiliation': 'Integrative Physiology Laboratory, Department of Kinesiology and Nutrition, College of Applied Health Sciences, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'B O', 'Initials': 'BO', 'LastName': 'Fernhall', 'Affiliation': 'Integrative Physiology Laboratory, Department of Kinesiology and Nutrition, College of Applied Health Sciences, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Baynard', 'Affiliation': 'Integrative Physiology Laboratory, Department of Kinesiology and Nutrition, College of Applied Health Sciences, University of Illinois at Chicago, Chicago, IL.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002540'] 1595,33060548,Short- and Long-Term Stroboscopic Training Effects on Visuomotor Performance in Elite Youth Sports. Part 1: Reaction and Behavior.,"PURPOSE Recent research suggests that stroboscopic training is an effective tool to improve visual and visuomotor performance. However, many studies were limited by small samples, short training interventions, inexperienced athletes, and an exclusive focus on short-term effects. This first part of the study evaluates the short- and long-term effects of stroboscopic training on visuomotor reaction speed in elite athletes. METHODS Forty-five young elite badminton athletes participated in this study, of which 32 (13.7 yr) were included in the final data analysis. Participants were assigned to an intervention (stroboscopic vision) or control group (normal vision). Both groups performed identical badminton-specific training drills implemented into the regular training schedule. Before and after a 10-wk training period and after a 6-wk retention interval, athletes performed a laboratory reaction test to determine EMG onset and visuomotor reaction time (VMRT). In addition, a field test investigated stroboscopic training effects on the quality of ball-racquet contact and net drop performance. RESULTS VMRT decreased immediately after stroboscopic training (pre, 251 ms; post, 238 ms; P = 0.005, d = 0.63), and reactions remained significantly faster after the retention interval (retention, 241 ms; P = 0.041, d = 0.50). Analyses on EMG onset data suggested these adaptations were attributable to the premotor rather than the motor time. VMRT remained unchanged in the control group (pre, 252 ms; post, 256; retention, 253 ms; P > 0.99). Field test performance improvements were observed for the quality of ball-racquet contact and net drop performance; however, changes were not different between groups. CONCLUSIONS Stroboscopic training induced short- and long-term accelerations of visuomotor reaction speed in elite badminton players. Stroboscopic eyewear may be an effective training tool to accelerate visuomotor reactions in highly skilled athletes.",2021,Stroboscopic training induced short- and long-term accelerations of visuomotor reaction speed in elite badminton players.,"['elite badminton players', 'elite athletes', 'highly skilled athletes', 'Elite Youth Sports', '45 young elite badminton athletes participated in this study, of which 32 (13.7 years) were included in the final data analysis']","['Short- and Long-Term Stroboscopic Training', 'intervention (stroboscopic vision) or control group (normal vision', 'stroboscopic training', 'Stroboscopic training']","['visuomotor reactions', 'EMG onset and visuomotor reaction time (VMRT', 'Visuomotor Performance', 'visuomotor reaction speed', 'visual and visuomotor performance', 'VMRT']","[{'cui': 'C0004678', 'cui_str': 'Badminton'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4042873', 'cui_str': 'Adolescent Sports'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0234622', 'cui_str': 'Normal vision'}]","[{'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]",45.0,0.0174445,Stroboscopic training induced short- and long-term accelerations of visuomotor reaction speed in elite badminton players.,"[{'ForeName': 'Thorben', 'Initials': 'T', 'LastName': 'Hülsdünker', 'Affiliation': 'Department of Exercise and Sport Science, LUNEX International University of Health, Exercise and Sports, Differdange, LUXEMBOURG.'}, {'ForeName': 'Nadira', 'Initials': 'N', 'LastName': 'Gunasekara', 'Affiliation': 'Institute of Movement and Neurosciences, German Sport University Cologne, Cologne, GERMANY.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Mierau', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002541'] 1596,33060549,Short- and Long-Term Stroboscopic Training Effects on Visuomotor Performance in Elite Youth Sports. Part 2: Brain-Behavior Mechanisms.,"PURPOSE Stroboscopic training has repeatedly been shown to improve visuomotor abilities. However, although performance improvements were attributed to visual processes, information on the neurophysiological mechanisms is missing. Part 2 of this study investigated the effects of stroboscopic training on neural visual and motor functions and its contribution to training-induced changes in visuomotor reaction time. METHODS Forty-five young elite badminton athletes participated in this study, of which 32 (age, 13.7 yr) were included in the final data analysis. Participants were assigned to an intervention (stroboscopic vision) or control group (normal vision). Before and after a 10-wk training and after a 6-wk retention period, participants performed visual perception and reaction tasks in response to visual motion stimuli. The N2 and N2-r motion onset visual-evoked potentials, its linear combination (Vlc), and the BA6 negativity potential were determined using a 64-channel EEG. RESULTS A significant TIME-GROUP effect was observed for the Vlc score (P = 0.019, ηp2 = 0.18), indicating a lower Vlc in the intervention group. However, post hoc tests did not reach significance. Within-subject correlation analyses revealed that changes in reaction speed were related to latency changes in N2 (r = 0.59, P < 0.001), N2-r (r = -0.64, P < 0.001), and the combined Vlc (r = 0.68, P < 0.001). Regression analyses across participants including multiple (N2/N2-r) or single (Vlc) predictors provided an explained variance of >60% (N2/N2-r, r2 = 0.62; Vlc, r2 = 0.64). No training effects or correlations were observed for the BA6 negativity. CONCLUSIONS The results indicate that faster visuomotor reactions after stroboscopic training are accompanied by accelerated visual perception and processing, whereas motor processes seemed to be unaffected. Stroboscopic training may be promising to specifically address the visual system in visuomotor-demanding sports.",2021,"A significant Time × Group effect was observed for the Vlc score (p=0.019, ηp =0.18) indicating a lower Vlc in the intervention group.","['Elite Youth Sports', '45 young elite badminton athletes participated in this study, of which 32 (13.7 years) were included in the final data analysis']","['Short- and Long-Term Stroboscopic Training', 'intervention (stroboscopic vision) or control group (normal vision', 'stroboscopic training', 'Stroboscopic training']","['Vlc score', 'visuomotor reaction time', 'N2 and N2-r motion onset visual evoked potentials, its linear combination (Vlc) and the BA6 negativity potential', 'visuomotor abilities', 'visuomotor reactions', 'neural visual and motor functions', 'Visuomotor Performance', 'reaction speed', 'BA6 negativity']","[{'cui': 'C4042873', 'cui_str': 'Adolescent Sports'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0004678', 'cui_str': 'Badminton'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0234622', 'cui_str': 'Normal vision'}]","[{'cui': 'C0015217', 'cui_str': 'Visual evoked potential'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]",45.0,0.018238,"A significant Time × Group effect was observed for the Vlc score (p=0.019, ηp =0.18) indicating a lower Vlc in the intervention group.","[{'ForeName': 'Thorben', 'Initials': 'T', 'LastName': 'Hülsdünker', 'Affiliation': 'Department of Exercise and Sport Science, LUNEX International University of Health, Exercise and Sports, Differdange, LUXEMBOURG.'}, {'ForeName': 'Nadira', 'Initials': 'N', 'LastName': 'Gunasekara', 'Affiliation': 'Institute of Movement and Neurosciences, German Sport University Cologne, Cologne, GERMANY.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Mierau', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002543'] 1597,33058419,Evaluation of pain intensity in patients treated with aligners and conventional fixed appliances: Randomized clinical trial.,"OBJECTIVE This randomized clinical trial aimed to compare the pain intensity in patients treated with orthodontic aligners and conventional fixed appliances. SETTING AND SAMPLE POPULATION This study was a randomized clinical trial. The sample comprised 39 patients randomly allocated into 2 groups: OA (orthodontic aligners, n = 20) and FA (Fixed Appliance, n = 19). MATERIAL AND METHODS The pain intensity was measured by the visual analogue scale (VAS) in the following periods: T0 (baseline), T1 (seven days after appliance placement) and seven days after each return on the first (T2), third (T3) and sixth (T4) months. The following variables were also investigated in the baseline: conditioned pain modulation, anxiety levels, hypervigilance and catastrophizing. The VAS measurements between groups were compared by the Mann-Whitney test. Comparisons between periods within each group were performed by the Friedman test. Data regarding catastrophizing and hypervigilance were compared by the t test. All tests were applied at a significance level of 5%, with 95% confidence interval. RESULTS Both groups presented similar levels of anxiety, hypervigilance, catastrophizing and conditioned pain modulation. Both groups did not differ concerning the pain intensity in all periods. The intragroup evaluation revealed statistical differences between days in the FA group at all moments evaluated, for the OA group, similar findings between days were found for the T1 evaluation; however, at the 6-month period (T4), the pain levels varied over these days without statistical difference. Higher levels of pain were observed in the first seven days after appliance placement. CONCLUSION The pain intensity, usually mild, was not influenced by the appliance design, although different patterns of reported pain seem to occur between groups.",2021,"The intragroup evaluation revealed statistical differences between days in the FA group at all moments evaluated, for the OA group, similar findings between days were found for the T1 evaluation, however, at the 6 months period (T4), the pain levels varied over these days without statistical difference.","['patients treated with aligners and conventional fixed appliances', 'patients treated with orthodontic aligners and conventional fixed appliances']","['OA (orthodontic aligners, n=20) and FA (Fixed Appliance, n=19']","['visual analogue scale (VAS', 'VAS measurements', 'pain modulation, anxiety levels, hypervigilance and catastrophizing', 'pain levels', 'Higher levels of pain', 'pain intensity', 'anxiety, hypervigilance, catastrophizing and conditioned pain modulation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}]","[{'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0235013', 'cui_str': 'Hypervigilance'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",39.0,0.140197,"The intragroup evaluation revealed statistical differences between days in the FA group at all moments evaluated, for the OA group, similar findings between days were found for the T1 evaluation, however, at the 6 months period (T4), the pain levels varied over these days without statistical difference.","[{'ForeName': 'Cleomária Evelyn Vieira Freire', 'Initials': 'CEVF', 'LastName': 'Casteluci', 'Affiliation': 'Department of Orthodontics, University of North Paraná (UNOPAR), Londrina, Brazil.'}, {'ForeName': 'Paula Vanessa Pedron', 'Initials': 'PVP', 'LastName': 'Oltramari', 'Affiliation': 'Department of Orthodontics, University of North Paraná (UNOPAR), Londrina, Brazil.'}, {'ForeName': 'Paulo César Rodrigues', 'Initials': 'PCR', 'LastName': 'Conti', 'Affiliation': 'Department of Prosthodontics, Bauru School of Dentistry, Bauru Orofacial Pain Group, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Leonardo Rigoldi', 'Initials': 'LR', 'LastName': 'Bonjardim', 'Affiliation': 'Section of Head and Face Physiology, Department of Biological Sciences, Bauru School of Dentistry, Bauru Orofacial Pain Group, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Renata Rodrigues', 'Initials': 'RR', 'LastName': 'de Almeida-Pedrin', 'Affiliation': 'Department of Orthodontics, University of North Paraná (UNOPAR), Londrina, Brazil.'}, {'ForeName': 'Thaís Maria Freire', 'Initials': 'TMF', 'LastName': 'Fernandes', 'Affiliation': 'Department of Orthodontics, University of North Paraná (UNOPAR), Londrina, Brazil.'}, {'ForeName': 'Marcio Rodrigues', 'Initials': 'MR', 'LastName': 'de Almeida', 'Affiliation': 'Department of Orthodontics, University of North Paraná (UNOPAR), Londrina, Brazil.'}, {'ForeName': 'Ana Cláudia', 'Initials': 'AC', 'LastName': 'de Castro Ferreira Conti', 'Affiliation': 'Department of Orthodontics, University of North Paraná (UNOPAR), Londrina, Brazil.'}]",Orthodontics & craniofacial research,['10.1111/ocr.12431'] 1598,33058901,Virtual and real-life ostracism and its impact on a subsequent acute stressor.,"While ostracism constitutes a social stressor with negative effects on physical and mental health, social inclusion seems to increase resilience. This may be true not only for face-to-face settings, but also for computer-mediated interactions. Hence, this study examined the differences between ostracism and social inclusion in real-life or Virtual Reality (VR) regarding self-reported stress, neuroendocrine and cardiovascular reactivity in a subsequent real-life socio-evaluative task. 84 females were randomly assigned to a 3 (agency: face-to-face/human controlled VR-avatar/computer VR-agent) x 2 (inclusion status: inclusion/exclusion) between-subject design using a Cyberball paradigm. Subsequently, they were exposed to a real-life Trier Social Stress Test (TSST). Results indicate that the experience of ostracism constitutes a threat to fundamental social needs independent of agency. Excluded participants showed cardiovascular reactivity during TSST; also face-to-face and avatar excluded individuals had elevated salivary cortisol levels. Included participants reported more perceived social support during Cyberball and showed a blunted cortisol response to the TSST. These results suggest that face-to-face and avatar-related ostracism provokes responses in the hypothalamic-pituitary-adrenal (HPA) axis and the sympathetic nervous system (SNS). Furthermore, they reveal that social inclusion may act as a stress-protector as it alters HPA- and SNS-related stress responsiveness to subsequent stressors.",2021,Excluded participants showed cardiovascular reactivity during TSST; also face-to-face and avatar excluded individuals had elevated salivary cortisol levels.,['84 females'],['3 (agency: face-to-face/human controlled VR-avatar/computer VR-agent) x 2 (inclusion status: inclusion/exclusion) between-subject design using a Cyberball paradigm'],"['cardiovascular reactivity', 'elevated salivary cortisol levels', 'perceived social support', 'blunted cortisol response']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}]",84.0,0.0106574,Excluded participants showed cardiovascular reactivity during TSST; also face-to-face and avatar excluded individuals had elevated salivary cortisol levels.,"[{'ForeName': 'Oswald D', 'Initials': 'OD', 'LastName': 'Kothgassner', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Medical University of Vienna, Vienna, Austria; Department of Clinical and Health Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Goreis', 'Affiliation': 'Department of Clinical and Health Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria; Outpatient Unit for Research, Teaching and Practice, Faculty of Psychology, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Glenk', 'Affiliation': 'Department of Comparative Medicine, Messerli Research Institute, University of Veterinary Medicine Vienna, Medical University Vienna and University, Vienna, Austria.'}, {'ForeName': 'Johanna Xenia', 'Initials': 'JX', 'LastName': 'Kafka', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Beutl', 'Affiliation': 'Working Group Entertainment Computing, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Kryspin-Exner', 'Affiliation': 'Department of Clinical and Health Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Hlavacs', 'Affiliation': 'Working Group Entertainment Computing, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Palme', 'Affiliation': 'Department of Biomedical Sciences, University of Veterinary Medicine, Vienna, Austria.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Felnhofer', 'Affiliation': 'Department of Clinical and Health Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria; Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna, Austria. Electronic address: anna.felnhofer@meduniwien.ac.at.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113205'] 1599,33065070,SGLT2 inhibitors and thiazide enhance excretion of DEHP toxic metabolites in subjects with type 2 diabetes: A randomized clinical trial.,"OBJECTIVE Phthalates are non-persistent pollutants related to impaired metabolism and high cardiovascular risk. Their toxic metabolites are eliminated through urine and feces. Prevention policies are considered by the governments, although no therapeutic strategy to facilitate their elimination from the human body has been proposed so far. Aim of the present study was to verify, for the first time in humans, whether diuretics might be able to enhance phthalates' toxic metabolites urinary output. DESIGN AND METHODS We conducted a two-armed, parallel-design, randomized clinical trial. Thirty patients with type 2 diabetes and hypertension received a four week-treatment with Dapagliflozin 10 mg or Hydrochlorothiazide 12.5 mg. 24-hours urine were collected to measure urinary excretion of three major 2-ethylhexyl-phthalate (DEHP) metabolites, i.e. mono 2-ethylhexyl phthalate (MEHP), mono-2-ethyl-5-oxohexyl phthalate (MEOHP) and mono 2-ethyl-5-hydroxyhexyl phthalate (MEHHP). RESULTS 24-h urinary excretion of DEHP and MEHP was increased (+44%, p = 0.036; +49%, p = 0.0016) while MEOHP e MEHHP showed only a positive trend (+25%, p = 0.016; +36%, p = 0.062). Irrespective of the specific treatment, induced variations of daily urinary eliminations of MEHP metabolites were related with the 24-h urinary sodium (r = 0.42, p = 0.0226) and potassium (r = 0.54, p = 0.0026) excretion. Also, DEHP and MEOHP were related to sodium (r = 0·43, p = 0.0205; r = 0·44, p = 0.0168 respectively) but not to potassium. CONCLUSIONS Urinary phthalates excretion seems to occur mainly through sodium- and potassium-related mechanisms, apparently independent from the different diuretic effect. Both thiazide diuretics and SLGT2 inhibitors are effective into the removal of phthalates metabolites from the human body, reducing the human tissues' exposure to their toxicity.",2021,"RESULTS 24-hours urinary excretion of DEHP and MEHP was increased (+44%, p=0.036; +49%, p=0.0016) while MEOHP e MEHHP showed only a positive trend (+25%, p=0.016; +36%, p=0.062).","['Thirty patients with type 2 diabetes and hypertension', 'subjects with type 2 diabetes']","['SGLT2 inhibitors and thiazide', 'Dapaglifozin 10 mg or Hydrochlorothiazide', 'thiazide diuretics and SLGT2 inhibitors']","['DEHP toxic metabolites', '24-hours urinary excretion of DEHP and MEHP', 'DEHP and MEOHP', 'urinary excretion of three major 2-ethylhexyl-phthalate (DEHP) metabolites, i.e. mono 2-ethylhexyl phthalate (MEHP), mono-2-ethyl-5-oxohexyl phthalate (MEOHP) and mono 2-ethyl-5-hydroxyhexyl phthalate (MEHHP', '24-hour urinary sodium', 'daily urinary eliminations of MEHP metabolites']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C0012802', 'cui_str': 'Thiazide diuretic'}, {'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0012197', 'cui_str': 'Di-2-ethylhexyl phthalate'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0220894', 'cui_str': 'Phthalic acid ester'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1320408', 'cui_str': 'Urinary elimination status'}]",30.0,0.0815342,"RESULTS 24-hours urinary excretion of DEHP and MEHP was increased (+44%, p=0.036; +49%, p=0.0016) while MEOHP e MEHHP showed only a positive trend (+25%, p=0.016; +36%, p=0.062).","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Mengozzi', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Fabrizia', 'Initials': 'F', 'LastName': 'Carli', 'Affiliation': 'Institute of Clinical Physiology, National Research Council, Pisa, Italy.'}, {'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Guiducci', 'Affiliation': 'Institute of Clinical Physiology, National Research Council, Pisa, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Parolini', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Biancalana', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Gastaldelli', 'Affiliation': 'Institute of Clinical Physiology, National Research Council, Pisa, Italy. Electronic address: amalia@ifc.cnr.it.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Solini', 'Affiliation': 'Department of Surgical, Medical, Molecular and Critical Area Pathology, University of Pisa, Pisa, Italy. Electronic address: anna.solini@med.unipi.it.'}]",Environmental research,['10.1016/j.envres.2020.110316'] 1600,33260423,"Eating Behavior, Physical Activity and Exercise Training: A Randomized Controlled Trial in Young Healthy Adults.","Regular physical activity (PA) is an important part of the treatment of several medical conditions, including overweight and obesity, in which there may be a weakened appetite control. Eating behaviour traits influence weight control and may be different in active and sedentary subjects. This paper reports the relationships between the time spent in sedentary behaviour and physical activity (PA) of different intensity, and eating behaviour traits in young, healthy adults. Additionally, it reports the results of a six-month-long, randomized, controlled trial to examine the effect of an exercise intervention on eating behaviour traits. A total of 139 young (22.06 ± 2.26 years) healthy adults (68.35% women) with a Body Mass Index (BMI) of 24.95 ± 4.57 kg/m 2 were enrolled. Baseline assessments of habitual PA were made using wrist-worn triaxial accelerometers; eating behaviour traits were examined via the self-reported questionnaires: Binge Eating, Three-Factor Eating Questionnaire-R18 and Control of Eating Questionnaire. The subjects were then randomly assigned to one of three groups: control (usual lifestyle), moderate-intensity exercise (aerobic and resistance training 3¨C4 days/week at a heart rate equivalent to 60% of the heart rate reserve (HRres) for the aerobic component, and at 50% of the 1 repetition maximum (RM) for the resistance component), or vigorous-intensity exercise (the same training but at 80% HRres for half of the aerobic training, and 70% RM for the resistance training). At baseline, sedentary behaviour was inversely associated with binge eating ( r = -0.181, p < 0.05) and with uncontrolled eating ( r = -0.286, p = 0.001). Moderate PA (MPA) was inversely associated with craving control ( r = -0.188, p < 0.05). Moderate-to-vigorous PA (MVPA) was directly associated with binge eating ( r = 0.302, p < 0.001) and uncontrolled eating ( r = 0.346, p < 0.001), and inversely associated with craving control ( r = -0.170, p < 0.015). Overall, PA was directly associated with binge eating ( r = 0.275, p = 0.001), uncontrolled eating ( r = 0.321, p < 0.001) and emotional eating ( r = 0.204, p < 0.05). Additionally, only emotional eating was modified by the intervention, increasing in the vigorous-intensity exercise group ( p < 0.05). In summary, we observed that time spent in sedentary behaviour/PA of different intensity is associated with eating behaviour traits, especially binge eating in young adults. In contrast, the six-month exercise intervention did not lead to appreciable changes in eating behaviour traits.",2020,"Moderate-to-vigorous PA (MVPA) was directly associated with binge eating ( r = 0.302, p < 0.001) and uncontrolled eating ( r = 0.346, p < 0.001), and inversely associated with craving control ( r = -0.170, p < 0.015).","['young, healthy adults', 'active and sedentary subjects', 'Young Healthy Adults', '139 young (22.06 ± 2.26 years) healthy adults (68.35% women) with a Body Mass Index (BMI) of 24.95 ± 4.57 kg/m 2 were enrolled']","['Regular physical activity (PA', 'Eating Behavior, Physical Activity and Exercise Training', 'exercise intervention', 'control (usual lifestyle), moderate-intensity exercise (aerobic and resistance training 3¨C4 days/week at a heart rate equivalent to 60% of the heart rate reserve (HRres) for the aerobic component, and at 50% of the 1 repetition maximum (RM) for the resistance component), or vigorous-intensity exercise (the same training but at 80% HRres for half of the aerobic training, and 70% RM for the resistance training']","['emotional eating', 'craving control', 'binge eating', 'sedentary behaviour', 'Moderate PA (MPA', 'Moderate-to-vigorous PA (MVPA', 'questionnaires: Binge Eating, Three-Factor Eating Questionnaire-R18 and Control of Eating Questionnaire', 'eating behaviour traits', 'uncontrolled eating', 'sedentary behaviour and physical activity (PA) of different intensity, and eating behaviour traits']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0677547', 'cui_str': 'days/week'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0025147', 'cui_str': 'Medroxyprogesterone'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",139.0,0.026801,"Moderate-to-vigorous PA (MVPA) was directly associated with binge eating ( r = 0.302, p < 0.001) and uncontrolled eating ( r = 0.346, p < 0.001), and inversely associated with craving control ( r = -0.170, p < 0.015).","[{'ForeName': 'Wendy D', 'Initials': 'WD', 'LastName': 'Martinez-Avila', 'Affiliation': 'PROmoting FITness and Health through Physical Activity Research Group (PROFITH), Sport and Health University Research Institute (iMUDS), University of Granada, 18007 Granada, Spain.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Sanchez-Delgado', 'Affiliation': 'PROmoting FITness and Health through Physical Activity Research Group (PROFITH), Sport and Health University Research Institute (iMUDS), University of Granada, 18007 Granada, Spain.'}, {'ForeName': 'Francisco M', 'Initials': 'FM', 'LastName': 'Acosta', 'Affiliation': 'PROmoting FITness and Health through Physical Activity Research Group (PROFITH), Sport and Health University Research Institute (iMUDS), University of Granada, 18007 Granada, Spain.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Jurado-Fasoli', 'Affiliation': 'PROmoting FITness and Health through Physical Activity Research Group (PROFITH), Sport and Health University Research Institute (iMUDS), University of Granada, 18007 Granada, Spain.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Oustric', 'Affiliation': 'Appetite Control and Energy Balance Group, School of Psychology, Faculty of Medicine and Health, University of Leeds, Leeds LS2 9JT, UK.'}, {'ForeName': 'Idoia', 'Initials': 'I', 'LastName': 'Labayen', 'Affiliation': ""Institute for Innovation & Sustainable Development in Food Chain (IS-FOOD), IDISNA, Navarra's Health Research Institute (IdiSNA), Public University of Navarra, 31006 Pamplona, Spain.""}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Blundell', 'Affiliation': 'Appetite Control and Energy Balance Group, School of Psychology, Faculty of Medicine and Health, University of Leeds, Leeds LS2 9JT, UK.'}, {'ForeName': 'Jonatan R', 'Initials': 'JR', 'LastName': 'Ruiz', 'Affiliation': 'PROmoting FITness and Health through Physical Activity Research Group (PROFITH), Sport and Health University Research Institute (iMUDS), University of Granada, 18007 Granada, Spain.'}]",Nutrients,['10.3390/nu12123685'] 1601,33259910,"The effect of Kneipp treatment hydrotherapy on secretory IgA in young children: A controlled, non-randomized clinical pilot study.","OBJECTIVES This pilot study analyses the effect and feasibility of hydrotherapeutic Kneipp arm affusions on secretory immunoglobulin A (sIgA) and classic cold symptoms in children 3-6 years of age. STUDY DESIGN A controlled, non-randomized, clinical pilot study was undertaken. INTERVENTION This descriptive hydrotherapeutic intervention treated children aged 3-6 with Kneipp arm affusions over four weeks. The control group received no intervention. At baseline and after the intervention, secretory IgA was measured, cold symptoms were assessed by means of the Common Cold Questionnaire (CCQ), and a semi-structured follow-up qualitative interview of the parents in the intervention group was conducted on acceptance and susceptibility to infection of the respiratory tract. RESULTS Fifteen participants were included in the intervention group and 15 were in the control group. The Kneipp arm affusions intervention was conducted at home and well-accepted by the children. No differences developed between the groups regarding sIgA. Comparing the symptoms by means of CCQ did not show symptoms of respiratory tract infections. In the intervention group, rhinitis occurred less frequently (26.7 % vs. 66.7 %, p = 0.057). In the qualitative analysis, 9/13 parents described an improvement in susceptibility to infections of the respiratory tract. CONCLUSION Due to the pilot character of this study, home hydrotherapy (Kneipp arm affusions) in healthy children is feasible but did not influence sIgA levels. The influence on infections of the respiratory tract after the intervention phase should be interpreted carefully. In qualitative interviews, parents described less susceptibility to infections of the respiratory tract by their children.",2021,"In the intervention group, rhinitis occurred less frequently (26.7% vs. 66.7%, p = 0.057).","['children 3-6 years of age', 'healthy children', 'Fifteen participants were included in the intervention group and 15 were in the control group', 'young children', 'treated children aged 3-6 with Kneipp arm affusions over four weeks']","['Kneipp treatment hydrotherapy', 'hydrotherapeutic intervention', 'no intervention', 'hydrotherapeutic Kneipp']","['secretory immunoglobulin A (sIgA) and classic cold symptoms', 'susceptibility to infections of the respiratory tract', 'rhinitis']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0020838', 'cui_str': 'Immunoglobulin A secretory'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0863093', 'cui_str': 'Cold symptoms'}, {'cui': 'C0521978', 'cui_str': 'Susceptibility to infections'}, {'cui': 'C0035237', 'cui_str': 'Structure of respiratory system'}, {'cui': 'C0008711', 'cui_str': 'Chronic rhinitis'}]",15.0,0.0432896,"In the intervention group, rhinitis occurred less frequently (26.7% vs. 66.7%, p = 0.057).","[{'ForeName': 'Klaudia', 'Initials': 'K', 'LastName': 'Schulte', 'Affiliation': 'Department of Pediatric Oncology/Hematology, Otto-Heubner Centre for Pediatric and Adolescent Medicine (OHC), Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Augustenburger Platz 1, 13353 Berlin, Germany.'}, {'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Blakeslee', 'Affiliation': 'Department of Pediatric Oncology/Hematology, Otto-Heubner Centre for Pediatric and Adolescent Medicine (OHC), Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Augustenburger Platz 1, 13353 Berlin, Germany.'}, {'ForeName': 'Wiebke', 'Initials': 'W', 'LastName': 'Stritter', 'Affiliation': 'Department of Pediatric Oncology/Hematology, Otto-Heubner Centre for Pediatric and Adolescent Medicine (OHC), Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Augustenburger Platz 1, 13353 Berlin, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Eidenschink', 'Affiliation': 'Department of Pediatric Oncology/Hematology, Otto-Heubner Centre for Pediatric and Adolescent Medicine (OHC), Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Augustenburger Platz 1, 13353 Berlin, Germany.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Gündling', 'Affiliation': 'Dean of Studies Naturopathy and Complementary Medicine, Carl Remigius Medical School, Idstein, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Baumann', 'Affiliation': 'Chair of Medical Theory, Integrative and Anthroposophic Medicine, Faculty of Health, Witten/Herdecke University, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Seifert', 'Affiliation': 'Department of Pediatric Oncology/Hematology, Otto-Heubner Centre for Pediatric and Adolescent Medicine (OHC), Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Augustenburger Platz 1, 13353 Berlin, Germany; University of São Paulo, Faculty of Medicine, Department of Pediatrics São Paulo, Estado de Sao Paulo, Brazil.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102637'] 1602,33268562,Effects of Ibudilast on MRI Measures in the Phase 2 SPRINT-MS Study.,"OBJECTIVE To determine whether ibudilast has an effect on brain volume and new lesions in progressive forms of multiple sclerosis (MS). METHODS A randomized, placebo-controlled, blinded study evaluated ibudilast at a dose of up to 100 mg over 96 weeks in primary and secondary progressive MS. In this secondary analysis of a previously reported trial, secondary and tertiary endpoints included gray matter atrophy, new or enlarging T2 lesions as measured every 24 weeks, and new T1 hypointensities at 96 weeks. Whole brain atrophy measured by structural image evaluation, using normalization, of atrophy (SIENA) was a sensitivity analysis. RESULTS A total of 129 participants were assigned to ibudilast and 126 to placebo. New or enlarging T2 lesions were observed in 37.2% on ibudilast and 29.0% on placebo ( p = 0.82). New T1 hypointense lesions at 96 weeks were observed in 33.3% on ibudilast and 23.5% on placebo ( p = 0.11). Gray matter atrophy was reduced by 35% for those on ibudilast vs placebo ( p = 0.038). Progression of whole brain atrophy by SIENA was slowed by 20% in the ibudilast group compared with placebo ( p = 0.08). CONCLUSION Ibudilast treatment was associated with a reduction in gray matter atrophy. Ibudilast treatment was not associated with a reduction in new or enlarging T2 lesions or new T1 lesions. An effect on brain volume contributes to prior data that ibudilast appears to affect markers associated with neurodegenerative processes, but not inflammatory processes. CLASSIFICATION OF EVIDENCE This study provides Class II evidence that for people with MS, ibudilast does not significantly reduce new or enlarging T2 lesions or new T1 lesions.",2021,"Ibudilast treatment was not associated with a reduction in new or enlarging T2 lesions, or new T1 lesions.",['129 participants were assigned to ibudilast and 126 to'],['placebo'],"['Gray matter atrophy', 'gray matter atrophy', 'New T1 hypointense lesions', 'Progression of whole brain atrophy by SIENA', 'new or enlarging T2 lesions, or new T1 lesions', 'MRI measures', 'New or enlarging T2 lesions', 'gray matter atrophy, new or enlarging T2 lesions']","[{'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0123047', 'cui_str': 'ibudilast'}, {'cui': 'C0470256', 'cui_str': '126'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0235946', 'cui_str': 'Cerebral atrophy'}, {'cui': 'C0442800', 'cui_str': 'Enlarged'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",129.0,0.177457,"Ibudilast treatment was not associated with a reduction in new or enlarging T2 lesions, or new T1 lesions.","[{'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Naismith', 'Affiliation': 'From Washington University (R.T.N.), St. Louis, MO; Cleveland Clinic Foundation (R.A.B., K.N., C.G., R.J.F.), OH; University of Iowa (C.S.C., J.F., J.Y., E.K.), Iowa City; University of Rochester (A.D.G.), NY; Massachusetts General Hospital (M.K., E.C.K.), Harvard Medical School, Boston; McConnell Brain Imaging Centre (S.N.), Montreal Neurological Institute, McGill University; and NeuroRx Research (S.N.), Montreal, Canada. naismithr@wustl.edu.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Bermel', 'Affiliation': 'From Washington University (R.T.N.), St. Louis, MO; Cleveland Clinic Foundation (R.A.B., K.N., C.G., R.J.F.), OH; University of Iowa (C.S.C., J.F., J.Y., E.K.), Iowa City; University of Rochester (A.D.G.), NY; Massachusetts General Hospital (M.K., E.C.K.), Harvard Medical School, Boston; McConnell Brain Imaging Centre (S.N.), Montreal Neurological Institute, McGill University; and NeuroRx Research (S.N.), Montreal, Canada.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Coffey', 'Affiliation': 'From Washington University (R.T.N.), St. Louis, MO; Cleveland Clinic Foundation (R.A.B., K.N., C.G., R.J.F.), OH; University of Iowa (C.S.C., J.F., J.Y., E.K.), Iowa City; University of Rochester (A.D.G.), NY; Massachusetts General Hospital (M.K., E.C.K.), Harvard Medical School, Boston; McConnell Brain Imaging Centre (S.N.), Montreal Neurological Institute, McGill University; and NeuroRx Research (S.N.), Montreal, Canada.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Goodman', 'Affiliation': 'From Washington University (R.T.N.), St. Louis, MO; Cleveland Clinic Foundation (R.A.B., K.N., C.G., R.J.F.), OH; University of Iowa (C.S.C., J.F., J.Y., E.K.), Iowa City; University of Rochester (A.D.G.), NY; Massachusetts General Hospital (M.K., E.C.K.), Harvard Medical School, Boston; McConnell Brain Imaging Centre (S.N.), Montreal Neurological Institute, McGill University; and NeuroRx Research (S.N.), Montreal, Canada.'}, {'ForeName': 'Janel', 'Initials': 'J', 'LastName': 'Fedler', 'Affiliation': 'From Washington University (R.T.N.), St. Louis, MO; Cleveland Clinic Foundation (R.A.B., K.N., C.G., R.J.F.), OH; University of Iowa (C.S.C., J.F., J.Y., E.K.), Iowa City; University of Rochester (A.D.G.), NY; Massachusetts General Hospital (M.K., E.C.K.), Harvard Medical School, Boston; McConnell Brain Imaging Centre (S.N.), Montreal Neurological Institute, McGill University; and NeuroRx Research (S.N.), Montreal, Canada.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Kearney', 'Affiliation': 'From Washington University (R.T.N.), St. Louis, MO; Cleveland Clinic Foundation (R.A.B., K.N., C.G., R.J.F.), OH; University of Iowa (C.S.C., J.F., J.Y., E.K.), Iowa City; University of Rochester (A.D.G.), NY; Massachusetts General Hospital (M.K., E.C.K.), Harvard Medical School, Boston; McConnell Brain Imaging Centre (S.N.), Montreal Neurological Institute, McGill University; and NeuroRx Research (S.N.), Montreal, Canada.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Klawiter', 'Affiliation': 'From Washington University (R.T.N.), St. Louis, MO; Cleveland Clinic Foundation (R.A.B., K.N., C.G., R.J.F.), OH; University of Iowa (C.S.C., J.F., J.Y., E.K.), Iowa City; University of Rochester (A.D.G.), NY; Massachusetts General Hospital (M.K., E.C.K.), Harvard Medical School, Boston; McConnell Brain Imaging Centre (S.N.), Montreal Neurological Institute, McGill University; and NeuroRx Research (S.N.), Montreal, Canada.'}, {'ForeName': 'Kunio', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'From Washington University (R.T.N.), St. Louis, MO; Cleveland Clinic Foundation (R.A.B., K.N., C.G., R.J.F.), OH; University of Iowa (C.S.C., J.F., J.Y., E.K.), Iowa City; University of Rochester (A.D.G.), NY; Massachusetts General Hospital (M.K., E.C.K.), Harvard Medical School, Boston; McConnell Brain Imaging Centre (S.N.), Montreal Neurological Institute, McGill University; and NeuroRx Research (S.N.), Montreal, Canada.'}, {'ForeName': 'Sridar', 'Initials': 'S', 'LastName': 'Narayanan', 'Affiliation': 'From Washington University (R.T.N.), St. Louis, MO; Cleveland Clinic Foundation (R.A.B., K.N., C.G., R.J.F.), OH; University of Iowa (C.S.C., J.F., J.Y., E.K.), Iowa City; University of Rochester (A.D.G.), NY; Massachusetts General Hospital (M.K., E.C.K.), Harvard Medical School, Boston; McConnell Brain Imaging Centre (S.N.), Montreal Neurological Institute, McGill University; and NeuroRx Research (S.N.), Montreal, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Goebel', 'Affiliation': 'From Washington University (R.T.N.), St. Louis, MO; Cleveland Clinic Foundation (R.A.B., K.N., C.G., R.J.F.), OH; University of Iowa (C.S.C., J.F., J.Y., E.K.), Iowa City; University of Rochester (A.D.G.), NY; Massachusetts General Hospital (M.K., E.C.K.), Harvard Medical School, Boston; McConnell Brain Imaging Centre (S.N.), Montreal Neurological Institute, McGill University; and NeuroRx Research (S.N.), Montreal, Canada.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Yankey', 'Affiliation': 'From Washington University (R.T.N.), St. Louis, MO; Cleveland Clinic Foundation (R.A.B., K.N., C.G., R.J.F.), OH; University of Iowa (C.S.C., J.F., J.Y., E.K.), Iowa City; University of Rochester (A.D.G.), NY; Massachusetts General Hospital (M.K., E.C.K.), Harvard Medical School, Boston; McConnell Brain Imaging Centre (S.N.), Montreal Neurological Institute, McGill University; and NeuroRx Research (S.N.), Montreal, Canada.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Klingner', 'Affiliation': 'From Washington University (R.T.N.), St. Louis, MO; Cleveland Clinic Foundation (R.A.B., K.N., C.G., R.J.F.), OH; University of Iowa (C.S.C., J.F., J.Y., E.K.), Iowa City; University of Rochester (A.D.G.), NY; Massachusetts General Hospital (M.K., E.C.K.), Harvard Medical School, Boston; McConnell Brain Imaging Centre (S.N.), Montreal Neurological Institute, McGill University; and NeuroRx Research (S.N.), Montreal, Canada.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Fox', 'Affiliation': 'From Washington University (R.T.N.), St. Louis, MO; Cleveland Clinic Foundation (R.A.B., K.N., C.G., R.J.F.), OH; University of Iowa (C.S.C., J.F., J.Y., E.K.), Iowa City; University of Rochester (A.D.G.), NY; Massachusetts General Hospital (M.K., E.C.K.), Harvard Medical School, Boston; McConnell Brain Imaging Centre (S.N.), Montreal Neurological Institute, McGill University; and NeuroRx Research (S.N.), Montreal, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology,['10.1212/WNL.0000000000011314'] 1603,33290975,Feasibility of MRI-based radiomics features for predicting lymph node metastases and VEGF expression in cervical cancer.,"PURPOSE To investigate the predictive value of MRI-based radiomics features for lymph node metastasis (LNM) and vascular endothelial growth factor (VEGF) expression in patients with cervical cancer. METHOD A total of 163 patients with cervical cancer were enrolled in this study. A total of 134 patients were included for LNM differentiation, and 118 were included for VEGF expression discrimination. The patients were randomly assigned to the training group or test group at a ratio of 2:1. Radiomics features were extracted from T1WI enhanced and T2WI MRI scans of each patient, and tumor stage was also documented according to the International Federation of Gynecology and Obstetrics (FIGO) guidelines. The least absolute shrinkage and selection operator algorithm was used for feature selection. The results of 5-fold cross validation were applied to select the best classification models. The performances of the constructed models were further evaluated with the test group. RESULTS Sixteen radiomics features and the FIGO stage were selected to construct the LNM discrimination model. The LNM prediction model achieved the best diagnostic performance, with areas under the receiver operating curve (AUCs) of 0.95 and 0.88 in the training group and test group, respectively. Nine radiomics characteristics were screened to build the VEGF prediction model, with AUCs of 0.82 and 0.70 in the training group and test group, respectively. Decision curve analysis confirmed their clinical usefulness. CONCLUSIONS The presented radiomics prediction models demonstrated potential to noninvasively differentiate LNM and VEGF expression in cervical cancer.",2021,"The LNM prediction model achieved the best diagnostic performance, with areas under the receiver operating curve (AUCs) of 0.95 and 0.88 in the training group and test group, respectively.","['A total of 134 patients were included for LNM differentiation, and 118 were included for VEGF expression discrimination', '163 patients with cervical cancer', 'Sixteen radiomics features and the FIGO stage', 'patients with cervical cancer', 'cervical cancer']",['MRI-based radiomics features'],[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0686619', 'cui_str': 'Secondary malignant neoplasm of lymph node'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",[],163.0,0.0231192,"The LNM prediction model achieved the best diagnostic performance, with areas under the receiver operating curve (AUCs) of 0.95 and 0.88 in the training group and test group, respectively.","[{'ForeName': 'Xijia', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': ""Department of Radiology, Chongqing University Cancer Hospital & Chongqing Cancer Institute & Chongqing Cancer Hospital, Chongqing 400030, People's Republic of China; Key Laboratory for Biorheological Science and Technology of Ministry of Education (Chongqing University), Chongqing University Cancer Hospital & Chongqing Cancer Institute & Chongqing Cancer Hospital, Chongqing 400044, People's Republic of China.""}, {'ForeName': 'Meiling', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': ""Department of Radiology, Chongqing University Cancer Hospital & Chongqing Cancer Institute & Chongqing Cancer Hospital, Chongqing 400030, People's Republic of China; Key Laboratory for Biorheological Science and Technology of Ministry of Education (Chongqing University), Chongqing University Cancer Hospital & Chongqing Cancer Institute & Chongqing Cancer Hospital, Chongqing 400044, People's Republic of China.""}, {'ForeName': 'Jianqing', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': ""Clinical Science, Philips Healthcare, Shanghai, 200072, People's Republic of China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': ""Department of Radiology, Chongqing University Cancer Hospital & Chongqing Cancer Institute & Chongqing Cancer Hospital, Chongqing 400030, People's Republic of China; Key Laboratory for Biorheological Science and Technology of Ministry of Education (Chongqing University), Chongqing University Cancer Hospital & Chongqing Cancer Institute & Chongqing Cancer Hospital, Chongqing 400044, People's Republic of China.""}, {'ForeName': 'Daihong', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': ""Department of Radiology, Chongqing University Cancer Hospital & Chongqing Cancer Institute & Chongqing Cancer Hospital, Chongqing 400030, People's Republic of China; Key Laboratory for Biorheological Science and Technology of Ministry of Education (Chongqing University), Chongqing University Cancer Hospital & Chongqing Cancer Institute & Chongqing Cancer Hospital, Chongqing 400044, People's Republic of China.""}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Radiology, Chongqing University Cancer Hospital & Chongqing Cancer Institute & Chongqing Cancer Hospital, Chongqing 400030, People's Republic of China; Key Laboratory for Biorheological Science and Technology of Ministry of Education (Chongqing University), Chongqing University Cancer Hospital & Chongqing Cancer Institute & Chongqing Cancer Hospital, Chongqing 400044, People's Republic of China.""}, {'ForeName': 'Jiayang', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': ""Department of Radiology, Chongqing University Cancer Hospital & Chongqing Cancer Institute & Chongqing Cancer Hospital, Chongqing 400030, People's Republic of China; Key Laboratory for Biorheological Science and Technology of Ministry of Education (Chongqing University), Chongqing University Cancer Hospital & Chongqing Cancer Institute & Chongqing Cancer Hospital, Chongqing 400044, People's Republic of China.""}, {'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Radiology, Chongqing University Cancer Hospital & Chongqing Cancer Institute & Chongqing Cancer Hospital, Chongqing 400030, People's Republic of China; Key Laboratory for Biorheological Science and Technology of Ministry of Education (Chongqing University), Chongqing University Cancer Hospital & Chongqing Cancer Institute & Chongqing Cancer Hospital, Chongqing 400044, People's Republic of China.""}, {'ForeName': 'Jiuquan', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Radiology, Chongqing University Cancer Hospital & Chongqing Cancer Institute & Chongqing Cancer Hospital, Chongqing 400030, People's Republic of China; Key Laboratory for Biorheological Science and Technology of Ministry of Education (Chongqing University), Chongqing University Cancer Hospital & Chongqing Cancer Institute & Chongqing Cancer Hospital, Chongqing 400044, People's Republic of China. Electronic address: zhangjq_radiol@foxmail.com.""}]",European journal of radiology,['10.1016/j.ejrad.2020.109429'] 1604,33295550,Hypoglycemic effect of Moringa oleifera (moringa) compared with Smallanthus sonchifolius (yacon) on Rattus norvegicus with induced diabetes mellitus.,"OBJECTIVE To compare the hypoglycemic effect of the aqueous extract of Moringa oleifera (moringa), Smallanthus sonchifolius (yacon) and metformin on Rattus norvegicus, albino variety, with induced diabetes mellitus. MATERIALS AND METHODS Preclinical, experimental, controlled and randomized study. Diabetes was induced intraperitoneally with a dose of alloxan at 130 mg/kg. A total of 24 male Rattus norvegicus, albino variety, Holfzman strain (6 per group) were used. They were divided as follows: control group (no treatment), metformin group (14 mg/kg), M. oleifera group (200 mg/kg), and S. sonchifolius group (140 mg/kg), treatments were administered via orogastric tube for 15 days. Glycemia levels were determined using an Accu-Chek® Instant electronic glycometer (Roche). RESULTS Decreased glycemia was observed in the treatment groups: M. oleifera (p = 0.009), S. sonchifolius (p = 0.002) and metformin (p = 0.002), by 313 mg/dL, 281.5 mg/dL and 415 mg/dL, respectively. When comparing glycemia in the treated and control groups, no difference was observed (P > 0.05) at 24 hours and four days of treatment; while at the eighth (P < 0.05) and fifteenth day (P < 0.01) the treated groups had lower glycemia than the control group, but it was similar among them. CONCLUSION The aqueous extract of S. sonchifolius, M. oleifera, and metformin presented similar hypoglycemic effect in experimental rats with induced diabetes.",2020,"RESULTS Decreased glycemia was observed in the treatment groups: M. oleifera (p = 0.009), S. sonchifolius (p = 0.002) and metformin (p = 0.002), by 313 mg/dL, 281.5 mg/dL and 415 mg/dL, respectively.","['24 male Rattus norvegicus, albino variety, Holfzman strain (6 per group) were used', 'experimental rats with induced diabetes', 'Rattus norvegicus with induced diabetes mellitus']","['metformin', 'aqueous extract of Moringa oleifera (moringa), Smallanthus sonchifolius (yacon) and metformin', 'Moringa oleifera (moringa) compared with Smallanthus sonchifolius (yacon', 'alloxan']","['glycemia', 'Glycemia levels', 'hypoglycemic effect', 'lower glycemia']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0001916', 'cui_str': 'Albinism'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0949952', 'cui_str': 'Drumsticktree'}, {'cui': 'C0002151', 'cui_str': 'Alloxan'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2936720', 'cui_str': 'Hypoglycemic Effects'}, {'cui': 'C0441994', 'cui_str': 'Lower'}]",24.0,0.0243108,"RESULTS Decreased glycemia was observed in the treatment groups: M. oleifera (p = 0.009), S. sonchifolius (p = 0.002) and metformin (p = 0.002), by 313 mg/dL, 281.5 mg/dL and 415 mg/dL, respectively.","[{'ForeName': 'Otto W', 'Initials': 'OW', 'LastName': 'Vargas-Tineo', 'Affiliation': 'Facultad de Medicina Humana, Universidad de San Martín de Porres, Chiclayo, Perú.'}, {'ForeName': 'Dina M', 'Initials': 'DM', 'LastName': 'Segura-Muñoz', 'Affiliation': 'Facultad de Medicina Humana, Universidad de San Martín de Porres, Chiclayo, Perú.'}, {'ForeName': 'Lizzie K', 'Initials': 'LK', 'LastName': 'Becerra-Gutiérrez', 'Affiliation': 'Facultad de Medicina Humana, Universidad de San Martín de Porres, Chiclayo, Perú.'}, {'ForeName': 'José P', 'Initials': 'JP', 'LastName': 'Amado-Tineo', 'Affiliation': 'Facultad de Medicina, Universidad Nacional Mayor de San Marcos, Lima, Perú.'}, {'ForeName': 'Heber', 'Initials': 'H', 'LastName': 'Silva-Díaz', 'Affiliation': 'Facultad de Medicina Humana, Universidad de San Martín de Porres, Chiclayo, Perú.'}]",Revista peruana de medicina experimental y salud publica,['10.17843/rpmesp.2020.373.5275'] 1605,32871043,Prognostic scoring system and risk stratification in patients with emphysematous pyelonephritis: an 11-year prospective study at a tertiary referral centre.,"OBJECTIVES To define pre-morbid, clinical, laboratory, and imaging features and identify prognostic factors associated with morbidity and mortality in patients with emphysematous pyelonephritis (EPN) and develop a prognostic scoring system for improving management outcomes. PATIENTS AND METHODS From January 2009 to December 2019, we performed a prospective study of all patients with a suspected diagnosis of EPN referred to a specialist tertiary centre in South India. All patients who underwent non-contrast computed tomography of the abdomen and those diagnosed with EPN were included in this study. Demographic parameters, imaging, haematological and microbiology results were recorded. Patients were divided into three groups: Group 1, patients who survived without any intervention; Group 2, those who survived with surgical intervention; and Group 3, those who died with or without intervention. A prognostic scoring system was developed from 18 different parameters and risk stratification was developed. The scores were correlated with overall prognosis. RESULTS Data from 131 patients with EPN enrolled in the study were analysed: Group 1 (n = 22), Group 2 (n = 102) and Group 3 (n = 7). By using univariate analysis, 10 factors were identified to be significantly associated with prognosis. Diabetes mellitus was the most common comorbidity. Shock at initial admission indicated a poor prognosis and warranted immediate attention (P < 0.001). CONCLUSIONS A multi-disciplinary approach, a high index of clinical suspicion, an early diagnosis and administration of culture-specific antibiotics with identification of prognostic indicators and risk stratification, allows prompt and appropriate medical and surgical treatments that could improve EPN management outcomes.",2021,"Shock at initial admission indicated a poor prognosis and warranted immediate attention (P < 0.001). ","['131 patients with EPN enrolled in the study', 'From January 2009 to December 2019, we performed a prospective study of all patients with a suspected diagnosis of EPN referred to a specialist tertiary centre in South India', 'All patients who underwent non-contrast computed tomography of the abdomen and those diagnosed with EPN', 'patients with emphysematous pyelonephritis (EPN', 'patients with emphysematous pyelonephritis']",['surgical intervention'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0403379', 'cui_str': 'Emphysematous pyelonephritis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}]",[],131.0,0.0249649,"Shock at initial admission indicated a poor prognosis and warranted immediate attention (P < 0.001). ","[{'ForeName': 'Sriram', 'Initials': 'S', 'LastName': 'Krishnamoorthy', 'Affiliation': 'Department of Urology and Renal Transplantation, Sri Ramachandra Institute of Higher Education and Research, Chennai, India.'}, {'ForeName': 'Alimuddin', 'Initials': 'A', 'LastName': 'Zumla', 'Affiliation': 'Division of Infection and Immunity, Centre for Clinical Microbiology, University College London (UCL), London,, UK.'}, {'ForeName': 'Hariharasudhan', 'Initials': 'H', 'LastName': 'Sekar', 'Affiliation': 'Department of Urology and Renal Transplantation, Sri Ramachandra Institute of Higher Education and Research, Chennai, India.'}, {'ForeName': 'Asif', 'Initials': 'A', 'LastName': 'Muneer', 'Affiliation': 'Division of Surgery and Interventional Science UCL, Department of Urology and NIHR Biomedical Research Centre, UCL Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Gayathri', 'Initials': 'G', 'LastName': 'Thiruvengadam', 'Affiliation': 'Department of Bio-Statistics, Faculty of Allied Health Science, Sri Ramachandra Institute of Higher Education & Research, Chennai, India.'}, {'ForeName': 'Natarajan', 'Initials': 'N', 'LastName': 'Kumaresan', 'Affiliation': 'Department of Urology and Renal Transplantation, Sri Ramachandra Institute of Higher Education and Research, Chennai, India.'}]",BJU international,['10.1111/bju.15225'] 1606,33263359,Interventions for convergence insufficiency: a network meta-analysis.,"BACKGROUND Convergence insufficiency is a common binocular vision disorder in which the eyes have a strong tendency to drift outward (exophoria) with difficulty turning the eyes inward when reading or doing close work. OBJECTIVES To assess the comparative effectiveness and relative ranking of non-surgical interventions for convergence insufficiency through a systematic review and network meta-analysis (NMA). SEARCH METHODS We searched CENTRAL, MEDLINE, Embase, PubMed and three trials registers up to 20 September 2019. SELECTION CRITERIA We included randomized controlled trials (RCTs) examining any form of non-surgical intervention versus placebo, no treatment, sham treatment, or other non-surgical interventions. Participants were children and adults with symptomatic convergence insufficiency. DATA COLLECTION AND ANALYSIS We followed standard Cochrane methodology. We performed NMAs separately for children and adults. MAIN RESULTS We included 12 trials (six in children and six in adults) with a total of 1289 participants. Trials evaluated seven interventions: 1) office-based vergence/accommodative therapy with home reinforcement; 2) home-based pencil/target push-ups; 3) home-based computer vergence/accommodative therapy; 4) office-based vergence/accommodative therapy alone; 5) placebo vergence/accommodative therapy or other placebo intervention; 6) prism reading glasses; and 7) placebo reading glasses. Six RCTs in the pediatric population randomized 968 participants. Of these, the Convergence Insufficiency Treatment Trial (CITT) Investigator Group completed four RCTs with 737 participants. All four CITT RCTs were rated at low risk of bias. Diagnostic criteria and outcome measures were identical or similar among these trials. The four CITT RCTs contributed data to the pediatric NMA, incorporating interventions 1, 2, 3 and 5. When treatment success was defined by a composite outcome requiring both clinical measures of convergence to be normal, and also show a pre-specified magnitude of improvement, we found high-certainty evidence that office-based vergence/accommodative therapy with home reinforcement increases the chance of a successful outcome, compared with home-based computer vergence/accommodative therapy (risk ratio (RR) 1.96, 95% confidence interval (CI) 1.32 to 2.94), home-based pencil/target push-ups (RR 2.86, 95% CI 1.82 to 4.35); and placebo (RR 3.04, 95% CI 2.32 to 3.98). However, there may be no evidence of any treatment difference between home-based computer vergence/accommodative therapy and home-based pencil/target push-ups (RR 1.44, 95% CI 0.93 to 2.24; low-certainty evidence), or between either of the two home-based therapies and placebo therapy, for the outcome of treatment success. When treatment success was defined as the composite convergence and symptom success outcome, we found moderate-certainty evidence that participants who received office-based vergence/accommodative therapy with home reinforcement were 5.12 (95% CI 2.01 to 13.07) times more likely to achieve treatment success than those who received placebo therapy. We found low-certainty evidence that participants who received office-based vergence/accommodative therapy with home reinforcement might be 4.41 (95% CI 1.26 to 15.38) times more likely to achieve treatment success than those who received home-based pencil push-ups, and 4.65 (95% CI 1.23 to 17.54) times more likely than those who received home-based computer vergence/accommodative therapy. There was no evidence of any treatment difference between home-based pencil push-ups and home-based computer vergence/accommodative therapy, or between either of the two home-based therapies and placebo therapy. One RCT evaluated the effectiveness of base-in prism reading glasses in children. When base-in prism reading glasses were compared with placebo reading glasses, investigators found no evidence of a difference in the three outcome measures of near point convergence (NPC), positive fusional vergence (PFV), or symptom scores measured by the Convergence Insufficiency Symptom Survey (CISS). Six RCTs in the adult population randomized 321 participants. We rated only one RCT at low risk of bias. Because not all studies of adults included composite success data, we could not conduct NMAs for treatment success. We thus were limited to comparing the mean difference (MD) between interventions for improving NPC, PFV, and CISS scores individually using data from three RCTs (107 participants; interventions 1, 2, 4 and 5). Compared with placebo treatment, office-based vergence accommodative therapy was relatively more effective in improving PFV (MD 16.73, 95% CI 6.96 to 26.60), but there was no evidence of a difference for NPC or the CISS score. There was no evidence of difference for any other comparisons for any outcomes. One trial evaluated base-in prism glasses prescribed for near-work activities and found that the prism glasses group had fewer symptoms compared with the placebo glasses group at three months (MD -8.9, 95% CI -11.6 to -6.3). The trial found no evidence of a difference with this intervention in NPC or PFV. No adverse effects related to study treatments were reported for any of the included studies. Excellent adherence was reported for office-based vergence/accommodative therapy (96.6% or higher) in two trials. Reported adherence with home-based therapy was less consistent, with one study reporting decreasing adherence over time (weeks 7 to 12) and lower completion rates with home-based pencil/target push-ups. AUTHORS' CONCLUSIONS Current research suggests that office-based vergence/accommodative therapy with home reinforcement is more effective than home-based pencil/target push-ups or home-based computer vergence/accommodative therapy for children. In adults, evidence of the effectiveness of various non-surgical interventions is less clear.",2020,"There was no evidence of any treatment difference between home-based pencil push-ups and home-based computer vergence/accommodative therapy, or between either of the two home-based therapies and placebo therapy.","['pediatric population randomized 968 participants', 'children', 'adult population randomized 321 participants', '12 trials (six in children and six in adults) with a total of 1289 participants', 'children and adults', 'Embase, PubMed and three trials registers up to 20 September 2019', 'Participants were children and adults with symptomatic convergence insufficiency']","['placebo, no treatment, sham treatment, or other non-surgical interventions', 'office-based vergence/accommodative therapy with home reinforcement; 2) home-based pencil/target push-ups; 3) home-based computer vergence/accommodative therapy; 4) office-based vergence/accommodative therapy alone; 5) placebo vergence/accommodative therapy or other placebo intervention; 6) prism reading glasses; and 7) placebo reading glasses', 'placebo']","['near point convergence (NPC), positive fusional vergence (PFV), or symptom scores', 'adverse effects', 'NPC, PFV, and CISS scores', 'Excellent adherence', 'PFV', 'chance of a successful outcome']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0271379', 'cui_str': 'Convergence insufficiency'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}, {'cui': 'C0441059', 'cui_str': 'Pencil'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}]","[{'cui': 'C0423037', 'cui_str': 'Convergence near point'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0028587', 'cui_str': 'Nuclear Pore'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",968.0,0.383363,"There was no evidence of any treatment difference between home-based pencil push-ups and home-based computer vergence/accommodative therapy, or between either of the two home-based therapies and placebo therapy.","[{'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Scheiman', 'Affiliation': 'Salus University, Elkins Park, Pennsylvania, USA.'}, {'ForeName': 'Marjean T', 'Initials': 'MT', 'LastName': 'Kulp', 'Affiliation': 'College of Optometry, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Cotter', 'Affiliation': 'Southern California College of Optometry, Fullerton, California, USA.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Lawrenson', 'Affiliation': 'Centre for Applied Vision Research, School of Health Sciences, City University of London, London, UK.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Tianjing', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology, University of Colorado Denver Anschutz Medical Campus, Aurora, CO, USA.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD006768.pub3'] 1607,33261510,Live Renal Ultrasonography Facilitates Double-J Ureteral Stent Insertion at the Bedside: A Pilot Study for the COVID-19 Era.,"Objectives: To investigate the feasibility and efficacy of live renal ultrasonography to guide Double-J ureteral stent placement at the bedside. Patients and Methods: Between April 12 and June 5, 2020, patients presenting with acute ureteral obstruction requiring decompression were prospectively selected for ultrasound-guided bedside ureteral stent placement. During stent placement, upper tract access confirmed using ultrasound with or without retrograde injection of ultrasound contrast before Double-J stent insertion. A postprocedural abdominal X-ray was obtained for stent position confirmation. Results: Eight patients (four men and four women) were offered bedside ultrasound-guided ureteral stent placement, and all eight consented to proceed. Stents were placed in seven of eight patients. One patient had an impacted ureterovesical junction stone and stricture requiring ureteroscopy and laser lithotripsy in the operating room. All patients tolerated procedures without immediate complications. Conclusion: Live renal ultrasonography can facilitate a high success rate for bedside ureteral stent placement outside the operating room. This approach is an attractive alternative to fluoroscopy-guided stent placement in the operating room and is of particular value in the COVID-19 era when judicious use of these resources is salient.",2020,"All patients tolerated procedures without immediate complications. ","['One patient had an impacted ureterovesical junction stone and stricture requiring ureteroscopy and laser lithotripsy in the operating room', 'Eight patients (4 men, 4 women', 'Between April 12 and June 5, 2020, patients presenting with acute ureteral obstruction requiring decompression']","['live renal ultrasonography to guide double-J ureteral stent placement', 'ultrasound with or without retrograde injection of ultrasound contrast prior to double-J stent insertion', 'bedside ultrasound-guided ureteral stent placement', 'ultrasound-guided bedside ureteral stent placement', 'Live renal ultrasonography facilitates double-J ureteral stent insertion', 'Live renal ultrasonography']",[],"[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0206099', 'cui_str': 'Laser Lithotripsy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0041956', 'cui_str': 'Obstruction of ureter'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}]","[{'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0183518', 'cui_str': 'Ureteric stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0441293', 'cui_str': 'JJ-stent'}, {'cui': 'C0864052', 'cui_str': 'Ureteral stent insertion'}]",[],,0.0366708,"All patients tolerated procedures without immediate complications. ","[{'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Chappidi', 'Affiliation': 'Department of Urology, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Overland', 'Affiliation': 'Department of Urology, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Ahn', 'Affiliation': 'Department of Urology, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bayne', 'Affiliation': 'Department of Urology, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Chi', 'Affiliation': 'Department of Urology, University of California, San Francisco, San Francisco, California, USA.'}]",Journal of endourology,['10.1089/end.2020.0954'] 1608,33259771,Synthetic Versus Biologic Mesh for Complex Open Ventral Hernia Repair: A Pilot Randomized Controlled Trial.,"Background: Many surgeons utilize biologic mesh for elective complex ventral hernia repair (VHR; large hernias, contaminated fields, or patients with comorbid conditions). However, no randomized controlled trials (RCTs) have compared biologic and synthetic mesh. We hypothesize biologic mesh would result in fewer major complications at one-year post-operative compared with synthetic mesh. Patients and Methods: We performed a single-center, pilot RCT. All eligible patients undergoing complex, open VHR were randomly assigned to receive biologic or synthetic mesh placed in the retromuscular position. Primary outcome was major complications, namely, a composite of mesh infection, recurrence, or re-operation at one-year post-operative. Secondary outcomes included surgical site infections (SSI), seromas, hematomas, wound dehiscence, re-admissions, and Clavien-Dindo complication grade. Outcomes were assessed using Fisher exact test and Bayesian generalized linear models. Results: Of 87 patients, 44 were randomly assigned to biologic mesh and 43 to synthetic mesh. Most cases were wound class 2-4 (68%) and 75% had a hernia width >4 cm. Most patients were obese (70%) and had an American Society of Anesthesiogists (ASA) score of 3-4 (53%). Compared with patients in the synthetic mesh group, patients in the biologic mesh group had a higher percentage of: major complications at one-year post-operative (42.4% vs. 21.6%; relative risk [RR] = 1.96 [95% confidence interval {CI} = 0.94-4.08]; number needed to harm = 4.8; p = 0.071); SSI (15.9% vs. 9.3%; RR = 1.71 [95% CI = 0.54-5.42]; p = 0.362); wound dehiscence (25.0% vs. 14.0%; RR = 1.79 [95% CI = 0.73-4.41]; p = 0.205); and re-admissions (22.7% vs 9.3%; RR = 2.44 [95% CI = 0.83-7.20]; p = 0.105). Bayesian analysis demonstrated that compared with synthetic mesh, biologic mesh had a 95% probability of increased risk of major complications at one-year post-operative. No clear evidence of a difference was found on seromas, hematomas, or Clavien-Dindo complication grade. Conclusions: In elective complex open VHR, biologic mesh demonstrated no benefit compared with synthetic mesh in one-year outcomes. Moreover, Bayesian analysis suggests that biologic mesh may have an increased probability of major complications.",2020,"No clear evidence of a difference was found on seromas, hematomas, or Clavien-Dindo complication grade. ","['87 patients, 44 were randomly assigned to', 'Most patients were obese (70%) and had an American Society of Anesthesiogists (ASA) score of 3-4 (53', 'All eligible patients undergoing complex, open VHR', 'Complex Open Ventral Hernia Repair', 'patients with comorbid conditions']","['biologic mesh and 43 to synthetic mesh', 'biologic or synthetic mesh placed in the retromuscular position', 'Synthetic Versus Biologic Mesh']","['risk of major complications', 'percentage of: major complications', 'wound dehiscence', 'probability of major complications', 'major complications, namely, a composite of mesh infection, recurrence, or re-operation at one-year post-operative', 'surgical site infections (SSI), seromas, hematomas, wound dehiscence, re-admissions, and Clavien-Dindo complication grade', 'seromas, hematomas, or Clavien-Dindo complication grade']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1869199', 'cui_str': 'DUSP3 protein, human'}, {'cui': 'C0019334', 'cui_str': 'Repair of ventral hernia'}, {'cui': 'C1275743', 'cui_str': 'Co-morbid conditions'}]","[{'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0733755', 'cui_str': 'Position'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0259768', 'cui_str': 'Wound dehiscence'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",,0.357939,"No clear evidence of a difference was found on seromas, hematomas, or Clavien-Dindo complication grade. ","[{'ForeName': 'Oscar A', 'Initials': 'OA', 'LastName': 'Olavarria', 'Affiliation': 'Department of Surgery, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Bernardi', 'Affiliation': 'Department of Surgery, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Naila H', 'Initials': 'NH', 'LastName': 'Dhanani', 'Affiliation': 'Department of Surgery, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Nicole B', 'Initials': 'NB', 'LastName': 'Lyons', 'Affiliation': 'Department of Surgery, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Harvin', 'Affiliation': 'Department of Surgery, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Stefanos G', 'Initials': 'SG', 'LastName': 'Millas', 'Affiliation': 'Department of Surgery, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Tien C', 'Initials': 'TC', 'LastName': 'Ko', 'Affiliation': 'Department of Surgery, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Lillian S', 'Initials': 'LS', 'LastName': 'Kao', 'Affiliation': 'Department of Surgery, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Mike K', 'Initials': 'MK', 'LastName': 'Liang', 'Affiliation': 'Department of Surgery, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, Texas, USA.'}]",Surgical infections,['10.1089/sur.2020.166'] 1609,33259449,Effect of dexmedetomidine on Nociception Level Index-guided remifentanil antinociception: A randomised controlled trial.,"BACKGROUND The effect of dexmedetomidine on Nociception Level Index-guided (Medasense, Israel) antinociception to reduce intra-operative opioid requirements has not been previously investigated. OBJECTIVE We aimed to determine if low-dose dexmedetomidine would reduce remifentanil requirements during Nociception Level Index-guided antinociception without increasing complications associated with dexmedetomidine. DESIGN Double-blind randomised controlled trial. SETTING Two university teaching hospitals in Brussels, Belgium. PATIENTS American Society of Anesthesiologists 1 and 2 patients (n = 58) undergoing maxillofacial or cervicofacial surgery under propofol--remifentanil target-controlled infusion anaesthesia. INTERVENTIONS A 30 min infusion of dexmedetomidine, or equal volume of 0.9% NaCl, was infused at 1.2 μg kg-1 h-1 immediately preceding induction and then decreased to 0.6 μg kg-1 h-1 until 30 min before ending surgery. Nociception Level Index and frontal electroencephalogram guided the remifentanil and propofol infusions, respectively. MAIN OUTCOMES The primary outcome was the remifentanil requirement. Other outcomes included the propofol requirement, cardiovascular status and postoperative outcome. RESULTS Mean ± SD remifentanil (3.96 ± 1.95 vs. 4.42 ± 2.04 ng ml-1; P = 0.0024) and propofol (2.78 ± 1.36 vs. 3.06 ± 1.29 μg ml-1; P = 0.0046) TCI effect site concentrations were lower in the dexmedetomidine group at 30 min postincision and remained lower throughout surgery. When remifentanil (0.133 ± 0.085 vs. 0.198 ± 0.086 μg kg-1 min-1; P = 0.0074) and propofol (5.7 ± 2.72 vs. 7.4 ± 2.80 mg kg-1 h-1; P = 0.0228) requirements are represented as infusion rates, this effect became statistically significant at 2 h postincision. CONCLUSION In ASA 1 and 2 patients receiving Nociception Level Index-guided antinociception, dexmedetomidine decreases intra-operative remifentanil requirements. Combined frontal electroencephalogram and Nociception Level Index monitoring can measure dexmedetomidine's hypnotic and opioid-sparing effects during remifentanil-propofol target-controlled infusion anaesthesia. TRIAL REGISTRATIONS Clinicaltrials.gov: NCT03912740, EudraCT: 2018-004512-22.",2021,TCI effect site concentrations were lower in the dexmedetomidine group at 30 min postincision and remained lower throughout surgery.,"['Two university teaching hospitals in Brussels, Belgium', 'American Society of Anesthesiologists 1 and 2 patients (n\u200a=\u200a58) undergoing maxillofacial or cervicofacial surgery under propofol--remifentanil target-controlled infusion anaesthesia']","['dexmedetomidine', 'dexmedetomidine, or equal volume of 0.9% NaCl', 'remifentanil', 'propofol', 'remifentanil and propofol', 'remifentanil-propofol']","['Mean\u200a±\u200aSD remifentanil (3.96\u200a±', 'propofol requirement, cardiovascular status and postoperative outcome', 'TCI effect site concentrations', 'remifentanil requirement', 'Nociception Level Index']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C3163670', 'cui_str': 'Target controlled total intravenous anesthesia'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0234194', 'cui_str': 'Nociperception'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",58.0,0.525452,TCI effect site concentrations were lower in the dexmedetomidine group at 30 min postincision and remained lower throughout surgery.,"[{'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Coeckelenbergh', 'Affiliation': 'From the Department of Anaesthesiology, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium (SC, SD, LP, EE, LVO, LB), Department of Anaesthesiology, Saint Pierre University Hospital, Université Libre de Bruxelles, Brussels, Belgium (SC, DP, LDM, PK), EW Data Analysis, Brussels, Belgium (EE), Department of Ear-Nose-Throat Surgery, Saint Pierre University Hospital, Université Libre de Bruxelles, Brussels, Belgium (AR) and Department of Anaesthesiology, CHU Rennes, Université de Rennes, Rennes, France (JP-E).'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Doria', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Patricio', 'Affiliation': ''}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Perrin', 'Affiliation': ''}, {'ForeName': 'Edgard', 'Initials': 'E', 'LastName': 'Engelman', 'Affiliation': ''}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Rodriguez', 'Affiliation': ''}, {'ForeName': 'Livia', 'Initials': 'L', 'LastName': 'Di Marco', 'Affiliation': ''}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Van Obbergh', 'Affiliation': ''}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Estebe', 'Affiliation': ''}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Barvais', 'Affiliation': ''}, {'ForeName': 'Panayota', 'Initials': 'P', 'LastName': 'Kapessidou', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001402'] 1610,33268020,An association between resting state EEG parameters and the severity of topiramate-related cognitive impairment.,"INTRODUCTION Many commonly prescribed drugs cause cognitive deficits. We investigated whether parameters of the resting-state electroencephalogram (rsEEG) are related to the severity of cognitive impairments associated with administration of the antiseizure drug topiramate (TPM) and the benzodiazepine lorazepam (LZP). METHODS We conducted a double-blind, randomized, placebo-controlled crossover study. After a baseline visit, subjects completed three sessions at which they received either a single dose of TPM, LZP, or placebo. Four-hours after drug administration and at baseline, subjects completed a working memory (WM) task after their rsEEG was recorded. After quantifying drug-related behavioral (WM accuracy (ACC)/reaction time (RT)) and electrophysiological (alpha, theta, beta (1,2), gamma power) change for each subject, we constructed drug-specific mixed effects models of change for each WM and EEG measure. Regression models were constructed to characterize the relationship between baseline rsEEG measures and drug-related performance changes. RESULTS Linear mixed effects models showed theta power increases in response to TPM administration. The results of the regression models revealed a number of robust relationships between baseline rsEEG parameters and TPM-related, but not LZP-related, WM impairment. CONCLUSIONS We showed for the first time that parameters of the rsEEG are associated with the severity of TPM-related WM deficits; this suggests that rsEEG measures may have novel clinical applications in the future.",2021,"After quantifying drug-related behavioral (WM accuracy (ACC)/reaction time (RT)) and electrophysiological (alpha, theta, beta (1,2), gamma power) change for each subject, we constructed drug-specific mixed effects models of change for each WM and EEG measure.",[],"['benzodiazepine lorazepam (LZP', 'TPM, LZP, or placebo', 'antiseizure drug topiramate (TPM', 'placebo']","['behavioral (WM accuracy (ACC)/reaction time (RT)) and electrophysiological (alpha, theta, beta (1,2), gamma power) change']",[],"[{'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0024002', 'cui_str': 'Lorazepam'}, {'cui': 'C0076829', 'cui_str': 'topiramate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.102604,"After quantifying drug-related behavioral (WM accuracy (ACC)/reaction time (RT)) and electrophysiological (alpha, theta, beta (1,2), gamma power) change for each subject, we constructed drug-specific mixed effects models of change for each WM and EEG measure.","[{'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Barkley', 'Affiliation': 'Center for Clinical and Cognitive Neuropharmacology, Department of Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, 308 Harvard Street, Minneapolis, MN 55455, United States. Electronic address: barkl025@umn.edu.'}, {'ForeName': 'Zhenhong', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': 'Department of Biomedical Engineering, University of Florida, 1275 Center Drive, Gainesville, FL 32611, United States.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Fieberg', 'Affiliation': 'Division of Biostatistics, University of Minnesota, 429 Delaware Street SE, Minneapolis, MN 55455, United States. Electronic address: afieberg@umn.edu.'}, {'ForeName': 'Lynn E', 'Initials': 'LE', 'LastName': 'Eberly', 'Affiliation': 'Division of Biostatistics, University of Minnesota, 429 Delaware Street SE, Minneapolis, MN 55455, United States. Electronic address: leberly@umn.edu.'}, {'ForeName': 'Angela K', 'Initials': 'AK', 'LastName': 'Birnbaum', 'Affiliation': 'Center for Clinical and Cognitive Neuropharmacology, Department of Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, 308 Harvard Street, Minneapolis, MN 55455, United States. Electronic address: birnb002@umn.edu.'}, {'ForeName': 'Ilo E', 'Initials': 'IE', 'LastName': 'Leppik', 'Affiliation': 'Center for Clinical and Cognitive Neuropharmacology, Department of Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, 308 Harvard Street, Minneapolis, MN 55455, United States. Electronic address: leppi001@umn.edu.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Marino', 'Affiliation': 'Center for Clinical and Cognitive Neuropharmacology, Department of Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, 308 Harvard Street, Minneapolis, MN 55455, United States. Electronic address: marin007@umn.edu.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107598'] 1611,33266447,"Twelve-Week Daily Consumption of ad hoc Fortified Milk with ω-3, D, and Group B Vitamins Has a Positive Impact on Inflammaging Parameters: A Randomized Cross-Over Trial.","BACKGROUND AND AIM A state of chronic, subclinical inflammation known as inflammaging is present in elderly people and represents a risk factor for all age-related diseases. Dietary supplementation with ad hoc fortified foods seems an appealing strategy to counteract inflammaging. The purpose of this study was to test the efficacy of elderly-tailored fortified milk on inflammaging and different health parameters. METHODS A double-blind randomized cross-over study was performed on forty-eight volunteers aged 63-80 years. The fortified milk was enriched with ω-3 polyunsaturated fatty acids (eicosapentaenoic acid, EPA; docosahexaenoic acid, DHA), vitamins (25-hydroxyvitamin D, E, C, B6, B9, B12), and trace elements (zinc, selenium). The two intervention periods lasted for 12 weeks, with a 16-week washout intermission. RESULTS Compared to placebo, the consumption of fortified milk increased the circulating levels of different micronutrients, including vitamins and the ω-3 index of erythrocyte membranes. Conversely, it reduced the amount of arachidonic acid, homocysteine, and ω-6/ω-3 ratio. CONCLUSION Twelve-week daily consumption of ad hoc fortified milk has an overall positive impact on different health parameters related to inflammaging in the elderly.",2020,"Compared to placebo, the consumption of fortified milk increased the circulating levels of different micronutrients, including vitamins and the ω-3 index of erythrocyte membranes.","['elderly people', 'forty-eight volunteers aged 63-80 years']","['ω-3 polyunsaturated fatty acids (eicosapentaenoic acid, EPA; docosahexaenoic acid, DHA), vitamins (25-hydroxyvitamin D, E, C, B6, B9, B12), and trace elements (zinc, selenium', 'elderly-tailored fortified milk', 'placebo']","['circulating levels of different micronutrients, including vitamins and the ω-3 index of erythrocyte membranes', 'arachidonic acid, homocysteine, and ω-6/ω-3 ratio']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1532525', 'cui_str': 'Fortified milk'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0014780', 'cui_str': 'Erythrocyte Cytoskeleton'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",48.0,0.0830432,"Compared to placebo, the consumption of fortified milk increased the circulating levels of different micronutrients, including vitamins and the ω-3 index of erythrocyte membranes.","[{'ForeName': 'Morena', 'Initials': 'M', 'LastName': 'Martucci', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, 40138 Bologna, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Conte', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, 40138 Bologna, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bucci', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, 40138 Bologna, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Giampieri', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, 40138 Bologna, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Fabbri', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, 40138 Bologna, Italy.'}, {'ForeName': 'Maria Giustina', 'Initials': 'MG', 'LastName': 'Palmas', 'Affiliation': 'Alma Mater Research Institute on Global Challenges and Climate Change (Alma Climate), University of Bologna, 40126 Bologna, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Izzi', 'Affiliation': 'Alma Mater Research Institute on Global Challenges and Climate Change (Alma Climate), University of Bologna, 40126 Bologna, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Salvioli', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, 40138 Bologna, Italy.'}, {'ForeName': 'Angelo Vittorio', 'Initials': 'AV', 'LastName': 'Zambrini', 'Affiliation': 'Department of Quality, Innovation, Safety, Environment, Granarolo S.p.A., 40057 Bologna, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Orsi', 'Affiliation': 'Department of Quality, Innovation, Safety, Environment, Granarolo S.p.A., 40057 Bologna, Italy.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Brigidi', 'Affiliation': 'Unit of Microbial Ecology of Health, Department of Pharmacy and Biotechnology, University of Bologna, 40126 Bologna, Italy.'}, {'ForeName': 'Aurelia', 'Initials': 'A', 'LastName': 'Santoro', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, 40138 Bologna, Italy.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Capri', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, 40138 Bologna, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Monti', 'Affiliation': 'Department of Experimental and Clinical Biomedical Sciences ""Mario Serio"", University of Florence, 50134 Florence, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Franceschi', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, 40138 Bologna, Italy.'}]",Nutrients,['10.3390/nu12113580'] 1612,33789555,Metabarcoding analysis of gut microbiota of healthy individuals reveals impact of probiotic and maltodextrin consumption.,"In a previously published double-blind, placebo-controlled study, we showed that probiotics intake exerted a positive effect on sleep quality and a general improvement across time in different aspects of the profile of mood state, like sadness, anger, and fatigue in 33 healthy individuals. The present work investigates the impact of the probiotic product, constituted of Limosilactobacillus fermentum LF16, Lacticaseibacillus rhamnosus LR06, Lactiplantibacillus plantarum LP01 (all former members of Lactobacillus genus), and Bifidobacterium longum 04, on the gut microbiota composition of the same cohort through a metabarcoding analysis. Both the placebo and probiotic treatments had a significant impact on the microbiota composition. Statistical analysis showed that the microbiota of the individuals could be clustered into three groups, or bacteriotypes, at the baseline, and, inherently, bacterial compositions were linked to different responses to probiotic and placebo intakes. Interestingly, L. rhamnosus and L. fermentum were retrieved in the probiotic-treated cohort, while a bifidogenic effect of maltodextrin, used as placebo, was observed. The present study shed light on the importance of defining bacteriotypes to assess the impact of interventions on the gut microbiota and allowed to reveal microbial components which could be related to positive effects (i.e. sleep quality improvement) to be verified in further studies.",2021,"Statistical analysis showed that the microbiota of the individuals could be clustered into three groups, or bacteriotypes, at the baseline, and, inherently, bacterial compositions were linked to different responses to probiotic and placebo intakes.","['healthy individuals', '33 healthy individuals']","['probiotic and maltodextrin consumption', 'placebo', 'maltodextrin']","['sleep quality', 'microbiota composition', 'mood state, like sadness, anger, and fatigue']","[{'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C3536794', 'cui_str': 'Unhappiness'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",33.0,0.0918836,"Statistical analysis showed that the microbiota of the individuals could be clustered into three groups, or bacteriotypes, at the baseline, and, inherently, bacterial compositions were linked to different responses to probiotic and placebo intakes.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Calgaro', 'Affiliation': 'Department of Biotechnology, University of Verona, Verona, Strada le Grazie 15, 37134 Verona, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pandolfo', 'Affiliation': 'Department of Biotechnology, University of Verona, Verona, Strada le Grazie 15, 37134 Verona, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Salvetti', 'Affiliation': 'Department of Biotechnology, University of Verona, Verona, Strada le Grazie 15, 37134 Verona, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Marotta', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Larini', 'Affiliation': 'Department of Biotechnology, University of Verona, Verona, Strada le Grazie 15, 37134 Verona, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pane', 'Affiliation': 'Probiotical Research SRL, Via Enrico Mattei 3, 28100 Novara, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Amoruso', 'Affiliation': 'Probiotical Research SRL, Via Enrico Mattei 3, 28100 Novara, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Del Casale', 'Affiliation': 'Open Innovation Department, Microbion SRL, via Monte Carega, 22, 37057 San Giovanni Lupatoto, Verona, Italy.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Vitulo', 'Affiliation': 'Department of Biotechnology, University of Verona, Verona, Strada le Grazie 15, 37134 Verona, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fiorio', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'G E', 'Initials': 'GE', 'LastName': 'Felis', 'Affiliation': 'Department of Biotechnology, University of Verona, Verona, Strada le Grazie 15, 37134 Verona, Italy.'}]",Beneficial microbes,['10.3920/BM2020.0137'] 1613,33272841,Effects of a single bout of short-duration high-intensity and long-duration low-intensity exercise on insulin resistance and adiponectin/leptin ratio.,"OBJECTIVES Moderate-intensity exercise improves insulin sensitivity, which may depend on the intensity, duration, and frequency of exercise. We examined the effects of a single bout of short-duration high-intensity exercise (HIE) and long-duration lowintensity exercise (LIE) on insulin sensitivity and the adiponectin/leptin ratio in individuals with different body mass indices (BMIs) who do not exercise regularly. METHODS We enrolled 42 healthy volunteers aged 20-64 years and divided them into two groups based on BMI: BMI <24 kg/m 2 and BMI ≥27 kg/m 2 . They were randomly assigned to either the short-duration (20 min) HIE (70%-80% heart rate reserve, HRR) or long-duration (60 min) LIE training groups (30%-40% HRR). Glucose, insulin, adiponectin, and leptin levels were assessed before training and at 0, 30, 60, and 120 min after training. RESULTS We finally analyzed 27 normal weight and 9 obese individuals. No significant differences were observed in the baseline information of both BMI groups. Homeostatic model assessment for insulin resistance significantly improved for both exercise patterns in the normal weight group and for the HIE pattern in the obese group (P < 0.01), whereas the adiponectin/leptin ratio increased significantly only among normal weight participants with the LIE intervention. CONCLUSION Both exercise patterns in BMI <24 kg/m 2 and BMI ≥27 kg/m 2 benefit on insulin resistance. Therefore, people can choose the way they can fit to improve insulin resistance both short-duration high-intensity exercise and long-duration low-intensity exercise.",2021,"Homeostatic model assessment for insulin resistance significantly improved for both exercise patterns in the normal weight group and for the HIE pattern in the obese group (P < 0.01), whereas the adiponectin/leptin ratio increased significantly only among normal weight participants with the LIE intervention. ","['individuals with different body mass indices (BMIs) who do not exercise regularly', '42 healthy volunteers aged 20-64 years and divided them into two groups based on BMI: BMI <24 kg/m 2 and BMI ≥27 kg/m 2 ', '27 normal weight and 9 obese individuals']","['single bout of short-duration high-intensity exercise (HIE) and long-duration lowintensity exercise (LIE', 'single bout of short-duration high-intensity and long-duration low-intensity exercise']","['insulin sensitivity and the adiponectin/leptin ratio', 'Homeostatic model assessment for insulin resistance', 'Glucose, insulin, adiponectin, and leptin levels', 'insulin resistance and adiponectin/leptin ratio', 'adiponectin/leptin ratio']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0556454', 'cui_str': 'Exercises regularly'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",42.0,0.0718396,"Homeostatic model assessment for insulin resistance significantly improved for both exercise patterns in the normal weight group and for the HIE pattern in the obese group (P < 0.01), whereas the adiponectin/leptin ratio increased significantly only among normal weight participants with the LIE intervention. ","[{'ForeName': 'Hsiang-Han', 'Initials': 'HH', 'LastName': 'Kao', 'Affiliation': 'Department of Family Medicine, China Medical University Hospital, Taichung, Taiwan; Department of Family Medicine, College of Medicine, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Hua-Shui', 'Initials': 'HS', 'LastName': 'Hsu', 'Affiliation': 'Department of Family Medicine, China Medical University Hospital, Taichung, Taiwan; Department of Family Medicine, College of Medicine, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Tai-Hsien', 'Initials': 'TH', 'LastName': 'Wu', 'Affiliation': 'Department of Family Medicine, China Medical University Hospital, Taichung, Taiwan; Department of Family Medicine, College of Medicine, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Hui-Fen', 'Initials': 'HF', 'LastName': 'Chiang', 'Affiliation': 'Department of Family Medicine, China Medical University Hospital, Taichung, Taiwan; Department of Family Medicine, College of Medicine, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Hui-Ying', 'Initials': 'HY', 'LastName': 'Huang', 'Affiliation': 'Department of Nutrition, College of Biopharmaceutical and Food Sciences, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Hui-Ju', 'Initials': 'HJ', 'LastName': 'Wang', 'Affiliation': 'Department of Sports Medicine, College of Health Care, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Department of Family Medicine, China Medical University Hospital, Taichung, Taiwan; Department of Family Medicine, College of Medicine, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Wen-Yuan', 'Initials': 'WY', 'LastName': 'Lin', 'Affiliation': 'Department of Family Medicine, China Medical University Hospital, Taichung, Taiwan; Department of Family Medicine, College of Medicine, China Medical University, Taichung, Taiwan; Department of Social Medicine, College of Medicine, China Medical University, Taichung, Taiwan. Electronic address: wylin@mail.cmu.edu.tw.'}]",Obesity research & clinical practice,['10.1016/j.orcp.2020.09.007'] 1614,33272026,Lasting Effects of a Community-Based Self-Management Intervention for Patients With Type 2 Diabetes in China: Outcomes at 2-Year Follow-up of a Randomized Trial.,"This research is to evaluate the lasting effects of a community-based self-management intervention for patients with type 2 diabetes at 2-year follow-up in China. Five hundred patients with diabetes were recruited and randomly divided into intervention group and control group. Eight times standardized self-management intervention group activities were conducted. The results of physical examination, biochemical laboratory examination, health behavior, and self-efficacy information were collected before intervention, 3 months after intervention, and 2 years after intervention. The total score for self-efficacy in the intervention group increased from 96.12 ± 17.48 to 112.90 ± 14.58 after intervention and decreased after 2 years (106.98 ± 18.03; F = 6.64, P = .0014). The number of days of self-blood glucose monitoring in the intervention group was increased from 1 day per week to 2 days per week after intervention, and 2 days per week at 2-year follow-up ( F = 8.02, P = .0003). The frequency of average number of aerobic exercises in the intervention group increased from 6 days per week to 7 days per week after intervention and was 7 days per week at 2-year follow-up ( F = 3.63, P = .0269). Community-based self-management group intervention for patients with diabetes has long-term effects.",2021,"The frequency of average number of aerobic exercises in the intervention group increased from 6 days per week to 7 days per week after intervention and was 7 days per week at 2-year follow-up ( F = 3.63, P = .0269).","['patients with diabetes', 'patients with type 2 diabetes at 2-year follow-up in China', 'Patients With Type 2 Diabetes in China', 'Five hundred patients with diabetes']","['Community-based self-management group intervention', 'community-based self-management intervention', 'Community-Based Self-Management Intervention']","['frequency of average number of aerobic exercises', 'total score for self-efficacy', 'number of days of self-blood glucose monitoring', 'physical examination, biochemical laboratory examination, health behavior, and self-efficacy information']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C3816747', 'cui_str': '500'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0260877', 'cui_str': 'Laboratory examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",500.0,0.024296,"The frequency of average number of aerobic exercises in the intervention group increased from 6 days per week to 7 days per week after intervention and was 7 days per week at 2-year follow-up ( F = 3.63, P = .0269).","[{'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'National Center for Chronic and Noncommunicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Mao', 'Affiliation': 'National Center for Chronic and Noncommunicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Wenlan', 'Initials': 'W', 'LastName': 'Dong', 'Affiliation': 'National Center for Chronic and Noncommunicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Xingxing', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Beijing Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Jianqun', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'National Center for Chronic and Noncommunicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}]",Asia-Pacific journal of public health,['10.1177/1010539520975266'] 1615,33277978,Racial Disparities in Systemic Sclerosis: Short- and Long-Term Outcomes Among African American Participants of SLS I and II.,"OBJECTIVE To evaluate short- and long-term outcomes of African American (AA) participants of Scleroderma Lung Studies (SLS) I and II. METHODS SLS I randomized 158 participants with systemic sclerosis-interstitial lung disease (SSc-ILD) to 1 year of oral cyclophosphamide (CYC) versus placebo. SLS II randomized 142 participants with SSc-ILD to 1 year of oral CYC followed by 1 year of placebo versus 2 years of mycophenolate (MMF). Joint models compared the course of forced vital capacity (FVC) and diffusing capacity for carbon monoxide (DLCO) between AA and non-AA, and Cox proportional hazard models assessed long-term morbidity and mortality outcomes. RESULTS In SLS I, there was no difference in the course of the FVC or DLCO between AA and non-AA in either treatment arm. In SLS II, AA had an improved course of the FVC compared with non-AA in the CYC arm; in the MMF arm, there was no difference in FVC course. There was no difference in DLCO course in either arm. Time to death and respiratory failure were similar for AA and non-AA in SLS I. There was a trend for improved survival and time to respiratory failure in AA compared with non-AA in SLS II. AA race was not independently associated with mortality in the SLS I or II in the Cox models. CONCLUSION Data from two randomized controlled trials demonstrated that AA patients with SSc-ILD have similar morbidity and mortality outcomes compared with non-AA patients. These findings contrast with the racial disparities described in prior observational studies and warrant further investigation.",2021,There was a trend for improved survival and time to respiratory failure in AA compared with non-AA in SLS II.,"['Systemic Sclerosis', '158 participants with systemic sclerosis-interstitial lung disease (SSc-ILD) to 1 year of', '142 participants with SSc-ILD to 1 year of', 'African American Participants of SLS I and II', 'SLS', 'AA patients with SSc-ILD', 'African American (AA) participants of Scleroderma Lung Studies (SLS) I and II']","['oral CYC', 'mycophenolate (MMF', 'oral cyclophosphamide (CYC) versus placebo', 'placebo']","['DLCO course', 'morbidity and mortality outcomes', 'forced vital capacity (FVC) and diffusing capacity for carbon monoxide (DLCO', 'FVC course', 'survival and time to respiratory failure', 'Time to death and respiratory failure']","[{'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0037231', 'cui_str': 'Sjögren-Larsson syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}, {'cui': 'C0083765', 'cui_str': 'NMF protocol'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",158.0,0.165959,There was a trend for improved survival and time to respiratory failure in AA compared with non-AA in SLS II.,"[{'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Volkmann', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Steen', 'Affiliation': 'Georgetown University, Washington, DC, United States.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Roth', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Clements', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Furst', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Shervin', 'Initials': 'S', 'LastName': 'Assassi', 'Affiliation': 'University of Texas McGovern Medical School, Houston.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Khanna', 'Affiliation': 'University of Michigan Medical School, Ann Arbor.'}, {'ForeName': 'Grace-Hyun J', 'Initials': 'GJ', 'LastName': 'Kim', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Goldin', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Elashoff', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Donald P', 'Initials': 'DP', 'LastName': 'Tashkin', 'Affiliation': 'University of California, Los Angeles.'}]",ACR open rheumatology,['10.1002/acr2.11206'] 1616,33277579,Increasing prosocial behavior and decreasing selfishness in the lab and everyday life.,"The tension between selfishness and prosocial behavior is crucial to understanding many social interactions and conflicts. Currently little is known how to promote prosocial behaviors, especially in naturally occurring relationships outside the laboratory. We examined whether a psychological micro-intervention would promote prosocial behaviors in couples. Across two studies, we randomized dyads of couples to a micro-intervention (15 min), which increased prosocial behaviors by 28% and decreased selfish behaviors by 35% a week later in behavioral games in a dose-response manner. Using event sampling methodology, we further observed an increase in prosocial behaviors across one week that was most pronounced in participants who received the intervention. These results from the laboratory and everyday life are important for researchers interested in prosocial behavior and selfishness and have practical relevance for group interactions.",2020,"Using event sampling methodology, we further observed an increase in prosocial behaviors across one week that was most pronounced in participants who received the intervention.",['couples'],['psychological micro-intervention'],"['selfish behaviors', 'prosocial behaviors']","[{'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0296138,"Using event sampling methodology, we further observed an increase in prosocial behaviors across one week that was most pronounced in participants who received the intervention.","[{'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Gloster', 'Affiliation': 'Division of Clinical Psychology and Intervention Science, Faculty of Psychology, University of Basel, Missionsstrasse 62 A, 4055, Basel, Switzerland. andrew.gloster@unibas.ch.'}, {'ForeName': 'Marcia T B', 'Initials': 'MTB', 'LastName': 'Rinner', 'Affiliation': 'Division of Clinical Psychology and Intervention Science, Faculty of Psychology, University of Basel, Missionsstrasse 62 A, 4055, Basel, Switzerland.'}, {'ForeName': 'Andrea H', 'Initials': 'AH', 'LastName': 'Meyer', 'Affiliation': 'Division of Clinical Psychology & Epidemiology, Faculty of Psychology, University of Basel, Basel, Switzerland.'}]",Scientific reports,['10.1038/s41598-020-78251-z'] 1617,33276125,Intrauterine Devices and Sexually Transmitted Infection among Older Adolescents and Young Adults in a Cluster Randomized Trial.,"STUDY OBJECTIVE Provider misconceptions regarding intrauterine device (IUD) safety for adolescents and young women can unnecessarily limit contraceptive options offered; we sought to evaluate rates of Neisseria gonorrhoeae or Chlamydia trachomatis (GC/CT) diagnoses among young women who adopted IUDs. DESIGN Secondary analysis of a cluster-randomized provider educational trial. SETTING Forty US-based reproductive health centers. PARTICIPANTS We followed 1350 participants for 12 months aged 18-25 years who sought contraceptive care. INTERVENTIONS The parent study assessed the effect of provider training on evidence-based contraceptive counseling. MAIN OUTCOME MEASURES We assessed incidence of GC/CT diagnoses according to IUD use and sexually transmitted infection risk factors using Cox regression modeling and generalized estimating equations. RESULTS Two hundred four participants had GC/CT history at baseline; 103 received a new GC/CT diagnosis over the 12-month follow-up period. IUDs were initiated by 194 participants. Incidence of GC/CT diagnosis was 10.0 per 100 person-years during IUD use vs 8.0 otherwise. In adjusted models, IUD use (adjusted hazard ratio [aHR], 1.31; 95% confidence interval [CI], 0.71-2.40), adolescent age (aHR, 1.28; 95% CI, 0.72-2.27), history of GC/CT (aHR, 1.23; 95% CI, 0.75-2.00), and intervention status (aHR, 1.12; 95% CI, 0.74-1.71) were not associated with GC/CT diagnosis; however, new GC/CT diagnosis rates were significantly higher among individuals who reported multiple partners at baseline (aHR, 2.0; 95% CI, 1.34-2.98). CONCLUSION In this young study population with GC/CT history, this use of IUDs was safe and did not lead to increased GC/CT diagnoses. However, results highlighted the importance of dual sexually transmitted infection and pregnancy protection for participants with multiple partners.",2020,"In adjusted models, IUD use (aHR 1.31, 95% CI 0.71-2.40), adolescent age (aHR 1.28, 95% CI 0.72-2.27), history of GC/CT (aHR 1.23, 95% CI 0.75-2.00) and intervention status (aHR 1.12, 95% CI 0.74-1.71) were not associated with GC/CT diagnosis; however, new GC/CT diagnosis rates were significantly higher among individuals reporting multiple partners at baseline (aHR 2.0, 95%CI 1.34-2.98). ","['40 U.S.-based reproductive health centers', '204 participants had GC/CT history at baseline; 103 received a', '1,350 participants aged 18-25 seeking contraceptive care', 'adolescents and young women', 'older adolescents and young adults', 'participants with multiple partners', 'young women adopting intrauterine devices']","['Intrauterine devices', 'new GC/CT diagnosis', 'provider training']","['incidence of N gonorrhaeae or C trachomatis (GC/CT) diagnoses', 'new GC/CT diagnosis rates', 'history of GC/CT', 'Incidence of GC/CT diagnosis']","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008151', 'cui_str': 'Chlamydia trachomatis'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0026767', 'cui_str': 'Multiple Partners'}, {'cui': 'C0425382', 'cui_str': 'Adopted'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}]","[{'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0008151', 'cui_str': 'Chlamydia trachomatis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0008151', 'cui_str': 'Chlamydia trachomatis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0262926', 'cui_str': 'History of'}]",1350.0,0.335279,"In adjusted models, IUD use (aHR 1.31, 95% CI 0.71-2.40), adolescent age (aHR 1.28, 95% CI 0.72-2.27), history of GC/CT (aHR 1.23, 95% CI 0.75-2.00) and intervention status (aHR 1.12, 95% CI 0.74-1.71) were not associated with GC/CT diagnosis; however, new GC/CT diagnosis rates were significantly higher among individuals reporting multiple partners at baseline (aHR 2.0, 95%CI 1.34-2.98). ","[{'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'El Ayadi', 'Affiliation': 'Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, San Francisco, California. Electronic address: alison.elayadi@ucsf.edu.'}, {'ForeName': 'Corinne H', 'Initials': 'CH', 'LastName': 'Rocca', 'Affiliation': 'Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Averbach', 'Affiliation': 'Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, San Francisco, California; Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Diego, San Diego, California.'}, {'ForeName': 'Suzan', 'Initials': 'S', 'LastName': 'Goodman', 'Affiliation': 'Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Darney', 'Affiliation': 'Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Ashlesha', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Planned Parenthood Federation of America, New York, New York.'}, {'ForeName': 'Cynthia C', 'Initials': 'CC', 'LastName': 'Harper', 'Affiliation': 'Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, San Francisco, California.'}]",Journal of pediatric and adolescent gynecology,['10.1016/j.jpag.2020.11.022'] 1618,33278293,Concurrent Retropubic Midurethral Sling and OnabotulinumtoxinA for Mixed Urinary Incontinence: A Randomized Controlled Trial.,"OBJECTIVE To evaluate whether retropubic midurethral sling combined with onabotulinumtoxinA is more effective than sling alone in improving mixed urinary incontinence symptoms. METHODS We conducted a prospective, double-blind, randomized, controlled trial of women with mixed urinary incontinence, planning to undergo midurethral sling. Women were randomly assigned to receive 100 unites of intradetrusor onabotulinumtoxinA or placebo during surgery. Participants completed the PGI-S (Patient Global Impression of Severity), the UDI-6 (Urinary Distress Inventory, Short Form), and the PFIQ-7 (Pelvic Floor Impact Questionnaire-Short Form 7) before and 3 months after surgery, and the primary outcome, PGI-I (Patient Global Impression of Improvement), 3 months postoperatively. Primary outcome was PGI-I score at 3 months for overall incontinence. We considered women ""improved"" with answers of ""very much better"" or ""much better"" on the PGI-I. Assuming a PGI-I response of ""improved"" in 66% of placebo and 93% of onabotulinumtoxinA participants, 68 women were needed to show a significant difference with 80% power at 0.05 significance level. RESULTS From March 2016 to November 2019, 78 women completed a 3-month follow-up (onabotulinumtoxinA: 41; placebo: 37). Mean age was 51 years (±10). On the PGI-I, the number who ""improved"" did not differ between groups at 3 months (83% vs 84%, P=1.0). The onabotulinumtoxinA group had less severe urgency symptoms as indicated by median urgency PGI-S scores (1 [interquartile range 1-2] vs 2 [interquartile range 1-3], P=.033) and greater improvement in urgency symptoms based on median urgency PGI-I score (1 [interquartile range 1-3] vs 2 [interquartile range 2-4], P=.028). At 3 months, median UDI-6, PFIQ-7, and PGI-S scores improved significantly from baseline in both groups. Similarly, UDI-6 and PFIQ-7 scores did not differ between groups. More women in the onabotulinumtoxinA arm initiated intermittent self-catheterization, (3% placebo; 12% onabotulinumtoxinA, P=.20) and experienced urinary tract infections (5% placebo; 22% onabotulinumtoxinA, P=.051), but these did not differ statistically. CONCLUSION Concurrent intradetrusor onabotulinumtoxinA injection did not improve overall incontinence symptoms at 3 months compared with placebo among women with mixed urinary incontinence undergoing midurethral sling placement. Women with mixed urinary incontinence undergoing sling report significant improvement in overall incontinence symptoms, regardless of the addition of onabotulinumtoxinA injections, but those receiving concurrent onabotulinumtoxinA injections reported less urgency severity and greater improvement in urgency symptoms at 3 months. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, NCT02678377.",2021,"At 3 months, median UDI-6, PFIQ-7, and PGI-S scores improved significantly from baseline in both groups.","['women with mixed urinary incontinence, planning to undergo midurethral sling', 'Women with mixed urinary incontinence undergoing sling', 'From March 2016 to November 2019, 78 women completed a 3-month follow-up (onabotulinumtoxinA: 41', 'Mixed Urinary Incontinence', 'Mean age was 51 years (±10', 'women with mixed urinary incontinence undergoing midurethral sling placement']","['intradetrusor onabotulinumtoxinA or placebo', 'placebo', 'Concurrent Retropubic Midurethral Sling and OnabotulinumtoxinA', 'Concurrent intradetrusor onabotulinumtoxinA injection', 'retropubic midurethral sling combined with onabotulinumtoxinA', 'onabotulinumtoxinA']","['PGI-I score at 3 months for overall incontinence', 'urgency symptoms', 'median UDI-6, PFIQ-7, and PGI-S scores', 'urgency severity', 'PGI-S (Patient Global Impression of Severity), the UDI-6 (Urinary Distress Inventory, Short Form), and the PFIQ-7 (Pelvic Floor Impact Questionnaire-Short Form 7', 'urgency symptoms based on median urgency PGI-I score', 'urinary tract infections', 'severe urgency symptoms', 'UDI-6 and PFIQ-7 scores', 'overall incontinence symptoms', 'median urgency PGI-S scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0869256', 'cui_str': 'Mixed urinary incontinence'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C3179501', 'cui_str': 'Mid-Urethral Slings'}, {'cui': 'C0183346', 'cui_str': 'Sling'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0205499', 'cui_str': 'Retropubic approach'}, {'cui': 'C3179501', 'cui_str': 'Mid-Urethral Slings'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0523816', 'cui_str': 'Pepsinogen I measurement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4720882', 'cui_str': 'Patient global impression of severity'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",68.0,0.725035,"At 3 months, median UDI-6, PFIQ-7, and PGI-S scores improved significantly from baseline in both groups.","[{'ForeName': 'Alix', 'Initials': 'A', 'LastName': 'Komar', 'Affiliation': 'Department of Obstetrics and Gynecology, the Division of Female Pelvic Medicine and Reconstructive Surgery, and the Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Carol E', 'Initials': 'CE', 'LastName': 'Bretschneider', 'Affiliation': ''}, {'ForeName': 'Margaret G', 'Initials': 'MG', 'LastName': 'Mueller', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Lewicky-Gaupp', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Collins', 'Affiliation': ''}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Geynisman-Tan', 'Affiliation': ''}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Tavathia', 'Affiliation': ''}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Kenton', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004198'] 1619,33297866,Magnetic Resonance Imaging-Guided Thrombolysis (0.6 mg/kg) Was Beneficial for Unknown Onset Stroke Above a Certain Core Size: THAWS RCT Substudy.,"BACKGROUND AND PURPOSE We determined to identify patients with unknown onset stroke who could have favorable 90-day outcomes after low-dose thrombolysis from the THAWS (Thrombolysis for Acute Wake-Up and Unclear-Onset Strokes With Alteplase at 0.6 mg/kg) database. METHODS This was a subanalysis of an investigator-initiated, multicenter, randomized, open-label, blinded-end point trial. Patients with stroke with a time last-known-well >4.5 hours who showed a mismatch between diffusion-weighted imaging (DWI) and fluid-attenuated inversion recovery were randomly assigned (1:1) to receive alteplase at 0.6 mg/kg intravenously or standard medical treatment. The patients were dichotomized by ischemic core size or National Institutes of Health Stroke Scale score, and the effects of assigned treatments were compared in each group. The efficacy outcome was favorable outcome at 90 days, defined as a modified Rankin Scale score of 0 to 1. RESULTS The median DWI-Alberta Stroke Program Early CT Score (ASPECTS) was 9, and the median ischemic core volume was 2.5 mL. Both favorable outcome (47.1% versus 48.3%) and any intracranial hemorrhage (26% versus 14%) at 22 to 36 hours were comparable between the 68 thrombolyzed patients and the 58 control patients. There was a significant treatment-by-cohort interaction for favorable outcome between dichotomized patients by ASPECTS on DWI ( P =0.026) and core volume ( P =0.035). Favorable outcome was more common in the alteplase group than in the control group in patients with DWI-ASPECTS 5 to 8 (RR, 4.75 [95% CI, 1.33-30.2]), although not in patients with DWI-ASPECTS 9 to 10. Favorable outcome tended to be more common in the alteplase group than in the control group in patients with core volume >6.4 mL (RR, 6.15 [95% CI, 0.87-43.64]), although not in patients with volume ≤6.4 mL. The frequency of any intracranial hemorrhage did not differ significantly between the 2 treatment groups in any dichotomized patients. CONCLUSIONS Patients developing unknown onset stroke with DWI-ASPECTS 5 to 8 showed favorable outcomes more commonly after low-dose thrombolysis than after standard treatment. Registration: URL: https://www.clinicaltrials.gov; Unique Identifier: NCT02002325. URL: https://www.umin.ac.jp/ctr; Unique Identifier: UMIN000011630.",2021,Both favorable outcome (47.1% versus 48.3%) and any intracranial hemorrhage (26% versus 14%) at 22 to 36 hours were comparable between the 68 thrombolyzed patients and the 58 control patients.,"['patients with unknown onset stroke who could have favorable 90-day outcomes after low-dose thrombolysis from the THAWS (Thrombolysis for Acute Wake-Up and Unclear-Onset Strokes', 'Patients with stroke with a time last-known-well >4.5 hours who showed a mismatch between diffusion-weighted imaging (DWI) and fluid-attenuated inversion recovery']","['alteplase at 0.6 mg/kg intravenously or standard medical treatment', 'Magnetic Resonance Imaging-Guided Thrombolysis']","['median ischemic core volume', 'modified Rankin Scale score of 0 to 1', 'frequency of any intracranial hemorrhage', 'ischemic core size or National Institutes of Health Stroke Scale score', 'median DWI-Alberta Stroke Program Early Computed Tomography Score', 'intracranial hemorrhage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0598801', 'cui_str': 'Diffusion weighted magnetic resonance imaging'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0021943', 'cui_str': 'Chromosome inversion'}]","[{'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]",,0.0997088,Both favorable outcome (47.1% versus 48.3%) and any intracranial hemorrhage (26% versus 14%) at 22 to 36 hours were comparable between the 68 thrombolyzed patients and the 58 control patients.,"[{'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Toyoda', 'Affiliation': 'Department of Cerebrovascular Medicine (K.T., M. Inoue, S.Y., M.F.-D., K. Miwa, M. Shiozawa, K. Minematsu, M.K.), National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Inoue', 'Affiliation': 'Department of Cerebrovascular Medicine (K.T., M. Inoue, S.Y., M.F.-D., K. Miwa, M. Shiozawa, K. Minematsu, M.K.), National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Sohei', 'Initials': 'S', 'LastName': 'Yoshimura', 'Affiliation': 'Department of Cerebrovascular Medicine (K.T., M. Inoue, S.Y., M.F.-D., K. Miwa, M. Shiozawa, K. Minematsu, M.K.), National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yamagami', 'Affiliation': 'Department of Stroke Neurology, National Hospital Organization Osaka National Hospital, Japan (H. Yamagami).'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Sasaki', 'Affiliation': 'Institute for Biomedical Sciences, Iwate Medical University, Yahaba, Japan (M. Sasaki, H. Yamamoto).'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Fukuda-Doi', 'Affiliation': 'Department of Cerebrovascular Medicine (K.T., M. Inoue, S.Y., M.F.-D., K. Miwa, M. Shiozawa, K. Minematsu, M.K.), National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Kazumi', 'Initials': 'K', 'LastName': 'Kimura', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan (K. Kimura, J.A.).'}, {'ForeName': 'Koko', 'Initials': 'K', 'LastName': 'Asakura', 'Affiliation': 'Center for Advancing Clinical and Translational Sciences (M.F.-D., K.A.), National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Miwa', 'Affiliation': 'Department of Cerebrovascular Medicine (K.T., M. Inoue, S.Y., M.F.-D., K. Miwa, M. Shiozawa, K. Minematsu, M.K.), National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Kanzawa', 'Affiliation': 'Department of Stroke Medicine, Institute of Brain and Blood Vessels, Mihara Memorial Hospital, Isesaki, Japan (T.K.).'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ihara', 'Affiliation': 'Department of Neurology (M. Ihara), National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Rei', 'Initials': 'R', 'LastName': 'Kondo', 'Affiliation': 'Department of Neurosurgery, Yamagata City Hospital Saiseikan, Japan (R.K.).'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Shiozawa', 'Affiliation': 'Department of Cerebrovascular Medicine (K.T., M. Inoue, S.Y., M.F.-D., K. Miwa, M. Shiozawa, K. Minematsu, M.K.), National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ohtaki', 'Affiliation': 'Department of Neurosurgery, Obihiro Kosei Hospital, Japan (M.O.).'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Kamiyama', 'Affiliation': 'Department of Neurosurgery, Nakamura Memorial Hospital, Sapporo, Japan (K. Kamiyama).'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Itabashi', 'Affiliation': 'Department of Stroke Neurology, Kohnan Hospital, Sendai, Japan (R.I.).'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Iwama', 'Affiliation': 'Department of Neurosurgery, Gifu University School of Medicine, Japan (T.I.).'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Aoki', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan (K. Kimura, J.A.).'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Minematsu', 'Affiliation': 'Department of Cerebrovascular Medicine (K.T., M. Inoue, S.Y., M.F.-D., K. Miwa, M. Shiozawa, K. Minematsu, M.K.), National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Haruko', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Institute for Biomedical Sciences, Iwate Medical University, Yahaba, Japan (M. Sasaki, H. Yamamoto).'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Koga', 'Affiliation': 'Department of Cerebrovascular Medicine (K.T., M. Inoue, S.Y., M.F.-D., K. Miwa, M. Shiozawa, K. Minematsu, M.K.), National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.120.030848'] 1620,33789683,"The effect of a one-year vigorous physical activity intervention on fitness, cognitive performance and mental health in young adolescents: the Fit to Study cluster randomised controlled trial.","BACKGROUND Physical activity (PA) may positively stimulate the brain, cognition and mental health during adolescence, a period of dynamic neurobiological development. High-intensity interval training (HIIT) or vigorous PA interventions are time-efficient, scalable and can be easily implemented in existing school curricula, yet their effects on cognitive, academic and mental health outcomes are unclear. The primary aim of the Fit to Study trial was to investigate whether a pragmatic and scalable HIIT-style VPA intervention delivered during school physical education (PE) could improve attainment in maths. The primary outcome has previously been reported and was null. Here, we report the effect of the intervention on prespecified secondary outcomes, including cardiorespiratory fitness, cognitive performance, and mental health in young adolescents. METHODS The Fit to Study cluster randomised controlled trial included Year 8 pupils (n = 18,261, aged 12-13) from 104 secondary state schools in South/Mid-England. Schools were randomised into an intervention condition (n = 52), in which PE teachers delivered an additional 10 min of VPA per PE lesson for one academic year (2017-2018), or into a ""PE as usual"" control condition. Secondary outcomes included assessments of cardiorespiratory fitness (20-m shuttle run), cognitive performance (executive functions, relational memory and processing speed) and mental health (Strength and Difficulties Questionnaire and self-esteem measures). The primary intention-to-treat (ITT) analysis used linear models and structural equation models with cluster-robust standard errors to test for intervention effects. A complier-average causal effect (CACE) was estimated using a two-stage least squares procedure. RESULTS The HIIT-style VPA intervention did not significantly improve cardiorespiratory fitness, cognitive performance (executive functions, relational memory or processed speed), or mental health (all p > 0.05). Subgroup analyses showed no significant moderation of intervention effects by sex, socioeconomic status or baseline fitness levels. Changes in cardiorespiratory fitness were not significantly related to changes in cognitive or mental health outcomes. The trial was marked by high drop-out and low intervention compliance. Findings from the CACE analysis were in line with those from the ITT analysis. CONCLUSION The one-academic year HIIT-style VPA intervention delivered during regular school PE did not significantly improve fitness, cognitive performance or mental health, but these findings should be interpreted with caution given low implementation fidelity and high drop-out. Well-controlled, large-scale, school-based trials that examine the effectiveness of HIIT-style interventions to enhance cognitive and mental health outcomes are warranted. TRIAL REGISTRATION ISRCTN registry, 15,730,512 . Trial protocol and analysis plan for primary outcome prospectively registered on 30th March 2017. ClinicalTrials.gov , NCT03286725 . Secondary measures (focus of current manuscript) retrospectively registered on 18 September 2017.",2021,"HIIT-style VPA intervention delivered during regular school PE did not significantly improve fitness, cognitive performance or mental health, but these findings should be interpreted with caution given low implementation fidelity and high drop-out.","['primary outcome prospectively registered on 30th March 2017', 'Year 8 pupils (n\u2009=\u200918,261, aged 12-13) from 104 secondary state schools in South/Mid-England', 'young adolescents']","['High-intensity interval training (HIIT) or vigorous PA interventions', 'PE teachers delivered an additional 10\u2009min of VPA per PE lesson', 'HIIT-style VPA intervention', 'one-year vigorous physical activity intervention', 'pragmatic and scalable HIIT-style VPA intervention delivered during school physical education (PE', 'HIIT-style interventions']","['cardiorespiratory fitness, cognitive performance (executive functions, relational memory or processed speed), or mental health', 'cardiorespiratory fitness, cognitive performance, and mental health', 'cardiorespiratory fitness', 'fitness, cognitive performance and mental health', 'cardiorespiratory fitness (20-m shuttle run), cognitive performance (executive functions, relational memory and processing speed) and mental health (Strength and Difficulties Questionnaire and self-esteem measures', 'fitness, cognitive performance or mental health', 'cognitive or mental health outcomes']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0042291', 'cui_str': 'valproic acid'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.158286,"HIIT-style VPA intervention delivered during regular school PE did not significantly improve fitness, cognitive performance or mental health, but these findings should be interpreted with caution given low implementation fidelity and high drop-out.","[{'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Wassenaar', 'Affiliation': 'Wellcome Centre For Integrative Neuroimaging, FMRIB, Nuffield Department of Clinical Neurosciences, University of Oxford, John Radcliffe Hospital, Headley Way, Oxford, OX3 9DU, UK.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Wheatley', 'Affiliation': 'Wellcome Centre For Integrative Neuroimaging, FMRIB, Nuffield Department of Clinical Neurosciences, University of Oxford, John Radcliffe Hospital, Headley Way, Oxford, OX3 9DU, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Beale', 'Affiliation': 'Department of Sport Health Sciences and Social Work, Centre for Movement Occupational and Rehabilitation Sciences, Oxford Brookes Centre for Nutrition and Health, Oxford Brookes University, Oxford, OX3 0BP, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Nichols', 'Affiliation': 'Wellcome Centre For Integrative Neuroimaging, FMRIB, Nuffield Department of Clinical Neurosciences, University of Oxford, John Radcliffe Hospital, Headley Way, Oxford, OX3 9DU, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Salvan', 'Affiliation': 'Wellcome Centre For Integrative Neuroimaging, FMRIB, Nuffield Department of Clinical Neurosciences, University of Oxford, John Radcliffe Hospital, Headley Way, Oxford, OX3 9DU, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Meaney', 'Affiliation': 'Department of Sport Health Sciences and Social Work, Centre for Movement Occupational and Rehabilitation Sciences, Oxford Brookes Centre for Nutrition and Health, Oxford Brookes University, Oxford, OX3 0BP, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Atherton', 'Affiliation': 'Wellcome Centre For Integrative Neuroimaging, FMRIB, Nuffield Department of Clinical Neurosciences, University of Oxford, John Radcliffe Hospital, Headley Way, Oxford, OX3 9DU, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Diaz-Ordaz', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Dawes', 'Affiliation': 'Department of Sport Health Sciences and Social Work, Centre for Movement Occupational and Rehabilitation Sciences, Oxford Brookes Centre for Nutrition and Health, Oxford Brookes University, Oxford, OX3 0BP, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Johansen-Berg', 'Affiliation': 'Wellcome Centre For Integrative Neuroimaging, FMRIB, Nuffield Department of Clinical Neurosciences, University of Oxford, John Radcliffe Hospital, Headley Way, Oxford, OX3 9DU, UK. Heidi.johansen-berg@ndcn.ox.ac.uk.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-021-01113-y'] 1621,33275162,Quality of life and sexual function after TVT surgery versus Bulkamid injection for primary stress urinary incontinence: 1 year results from a randomized clinical trial.,"INTRODUCTION AND HYPOTHESIS To assess changes in quality of life (QoL) and sexual function outcomes at 1 year after tension-free vaginal tape (TVT) versus polyacrylamide hydrogel injection (PAHG). METHODS In a randomized trial comparing TVT (n = 111) and PAHG (n = 113) treatments of stress urinary incontinence (SUI), we compared urinary incontinence and health-related QoL using the Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire, Short Form (IIQ-7), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) and RAND-36 Item Health Survey (RAND-36) at baseline and 1 year. RESULTS UDI-6 and IIQ-7 showed improved incontinence-related QoL (p = 0.001) from baseline in both groups except for difficulty emptying the bladder and pain/discomfort. At 1 year, TVT patients experienced less urinary symptom-related distress compared to PAHG (p < 0.001). Sexual function improved in both groups (p < 0.001 for TVT and p = 0.01 for PAHG) with higher scores for the physical section subscale (p < 0.001) for TVT. Health-related QoL (RAND-36) improved from baseline in both groups in physical and social functioning (p < 0.001) with better outcome in the TVT group for physical functioning (p < 0.001). Increase in pain from baseline (p = 0.02) was detected for TVT, but not for PAHG. However, there was no difference between the groups (p = 0.78). CONCLUSIONS In primary SUI, TVT and PAHG treatments both improved QoL and sexual function at 1 year. However, incontinence and health-related QoL scores were better in the TVT group. More pain compared to the baseline was reported after TVT, although there was no difference between groups. Clinical significance needs to be evaluated in long-term follow-up.",2021,"RESULTS UDI-6 and IIQ-7 showed improved incontinence-related QoL (p = 0.001) from baseline in both groups except for difficulty emptying the bladder and pain/discomfort.",['primary stress urinary incontinence'],"['TVT surgery versus Bulkamid injection', 'TVT', 'PAHG', 'tension-free vaginal tape (TVT) versus polyacrylamide hydrogel injection (PAHG']","['incontinence-related QoL', 'urinary incontinence and health-related QoL using the Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire, Short Form (IIQ-7), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) and RAND-36 Item Health Survey (RAND-36) at baseline and 1\xa0year', 'Quality of life and sexual function', 'quality of life (QoL) and sexual function outcomes', 'Sexual function', 'incontinence and health-related QoL scores', 'QoL and sexual function', 'Increase in pain', 'urinary symptom-related distress', 'Health-related QoL (RAND-36', 'physical section subscale', 'stress urinary incontinence (SUI', 'More pain']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}]","[{'cui': 'C1721083', 'cui_str': 'Tension-Free Vaginal Tape'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C2353119', 'cui_str': 'Bulkamid'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0137704', 'cui_str': 'polyacrylamide hydrogels'}]","[{'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}]",,0.113446,"RESULTS UDI-6 and IIQ-7 showed improved incontinence-related QoL (p = 0.001) from baseline in both groups except for difficulty emptying the bladder and pain/discomfort.","[{'ForeName': 'Anna-Maija', 'Initials': 'AM', 'LastName': 'Itkonen Freitas', 'Affiliation': 'Department of Obstetrics and Gynecology, Helsinki University Hospital, Helsinki University, PO BOX 140, 00029 HUS, Helsinki, Finland.'}, {'ForeName': 'Tomi S', 'Initials': 'TS', 'LastName': 'Mikkola', 'Affiliation': 'Department of Obstetrics and Gynecology, Helsinki University Hospital and Folkhälsan Research Center Biomedicum, Helsinki University, Helsinki, Finland.'}, {'ForeName': 'Päivi', 'Initials': 'P', 'LastName': 'Rahkola-Soisalo', 'Affiliation': 'Department of Obstetrics and Gynecology, Helsinki University Hospital, Helsinki University, PO BOX 140, 00029 HUS, Helsinki, Finland.'}, {'ForeName': 'Sari', 'Initials': 'S', 'LastName': 'Tulokas', 'Affiliation': 'Doctoral Programme in Clinical Research, Helsinki University, Helsinki, Finland.'}, {'ForeName': 'Maarit', 'Initials': 'M', 'LastName': 'Mentula', 'Affiliation': 'Department of Obstetrics and Gynecology, Helsinki University Hospital, Helsinki University, PO BOX 140, 00029 HUS, Helsinki, Finland. maarit.mentula@hus.fi.'}]",International urogynecology journal,['10.1007/s00192-020-04618-5'] 1622,33274441,Immersion and haptic feedback impacts on dental anesthesia technical skills virtual reality training.,"OBJECTIVES Administering anesthesia to the inferior alveolar nerve is 1 of the most stressful processes in dental training. Most studies using virtual reality (VR) for dental training have used non-immersive technologies. The purpose of this work is to assess the impact of immersive technologies on skills training. METHODS On May 2019, an experimental study was conducted with 163 clinical dental students, divided into 4 groups across 2 phases (preceptorship and training) with haptic feedback either On or Off. The participants trained on the inferior alveolar dental anesthesia procedure in a haptic VR simulator. Their technical skills were evaluated in terms of needle insertion features which were computed from a haptic device providing kinematic data. Also, the participants reported their subjective experience with syringe handling and simulator sickness. A machine learning method was implemented to automatically evaluate the needle insertion point performance of the student. RESULTS Groups receiving immersive preceptorship and/or immersive training showed more accuracy and confidence in administering the anesthesia. Participants perceived a high sense of realism with the haptic feedback when handling the syringe. The machine learning method was validated, with an accuracy of 84%, as a good classifier to assess a student's needle insertion point performance. CONCLUSIONS The immersive VR simulator allows the practice of the inferior alveolar nerve block under near real conditions and with immediate feedback to the dental student with respect to the needle insertion point. This machine learning based automatic evaluation provides a method to improve technical skills, contributing to dental training.",2021,The immersive VR simulator allows the practice of the inferior alveolar nerve block under near real conditions and with immediate feedback to the dental student with respect to the needle insertion point.,"['163 clinical dental students', 'participants trained on the inferior alveolar dental anesthesia procedure in a haptic VR simulator', 'dental anesthesia technical skills virtual reality training']","['haptic feedback either On or Off', 'immersive VR simulator', 'virtual reality (VR', 'immersive preceptorship and/or immersive training']",['accuracy and confidence'],"[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0032929', 'cui_str': 'Clinical Practicum'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",,0.0158474,The immersive VR simulator allows the practice of the inferior alveolar nerve block under near real conditions and with immediate feedback to the dental student with respect to the needle insertion point.,"[{'ForeName': 'Elen', 'Initials': 'E', 'LastName': 'Collaço', 'Affiliation': 'Computer and Digital Systems Engineering, Polytechnic School, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Elisabeti', 'Initials': 'E', 'LastName': 'Kira', 'Affiliation': 'Department of Statistics, Institute of Mathematics and Statistics, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Lucas H', 'Initials': 'LH', 'LastName': 'Sallaberry', 'Affiliation': 'Computer and Digital Systems Engineering, Polytechnic School, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Anna C M', 'Initials': 'ACM', 'LastName': 'Queiroz', 'Affiliation': 'School of Education and Virtual Human Interaction Lab, Stanford University, California, United States.'}, {'ForeName': 'Maria A A M', 'Initials': 'MAAM', 'LastName': 'Machado', 'Affiliation': 'Orthodontics and Public Health, Dentistry School, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'Oswaldo', 'Initials': 'O', 'LastName': 'Crivello', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Romero', 'Initials': 'R', 'LastName': 'Tori', 'Affiliation': 'Computer and Digital Systems Engineering, Polytechnic School, University of São Paulo, São Paulo, Brazil.'}]",Journal of dental education,['10.1002/jdd.12503'] 1623,33274389,"Residual, differential neurobehavioral deficits linger after multiple recovery nights following chronic sleep restriction or acute total sleep deprivation.","STUDY OBJECTIVES The amount of recovery sleep needed to fully restore well-established neurobehavioral deficits from sleep loss remains unknown, as does whether the recovery pattern differs across measures after total sleep deprivation (TSD) and chronic sleep restriction (SR). METHODS In total, 83 adults received two baseline nights (10-12-hour time in bed [TIB]) followed by five 4-hour TIB SR nights or 36-hour TSD and four recovery nights (R1-R4; 12-hour TIB). Neurobehavioral tests were completed every 2 hours during wakefulness and a Maintenance of Wakefulness Test measured physiological sleepiness. Polysomnography was collected on B2, R1, and R4 nights. RESULTS TSD and SR produced significant deficits in cognitive performance, increases in self-reported sleepiness and fatigue, decreases in vigor, and increases in physiological sleepiness. Neurobehavioral recovery from SR occurred after R1 and was maintained for all measures except Psychomotor Vigilance Test (PVT) lapses and response speed, which failed to completely recover. Neurobehavioral recovery from TSD occurred after R1 and was maintained for all cognitive and self-reported measures, except for vigor. After TSD and SR, R1 recovery sleep was longer and of higher efficiency and better quality than R4 recovery sleep. CONCLUSIONS PVT impairments from SR failed to reverse completely; by contrast, vigor did not recover after TSD; all other deficits were reversed after sleep loss. These results suggest that TSD and SR induce sustained, differential biological, physiological, and/or neural changes, which remarkably are not reversed with chronic, long-duration recovery sleep. Our findings have critical implications for the population at large and for military and health professionals.",2021,"Neurobehavioral recovery from TSD occurred after R1 and was maintained for all cognitive and self-reported measures, except for vigor.",['chronic sleep restriction or acute total sleep deprivation'],[],"['self-reported sleepiness and fatigue', 'Psychomotor Vigilance Test (PVT) lapses and response speed', 'Neurobehavioral recovery from TSD', 'Neurobehavioral tests', 'cognitive performance', 'Neurobehavioral recovery from SR', 'physiological sleepiness', 'total sleep deprivation (TSD) and chronic sleep restriction (SR', 'SR, R1 recovery sleep']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}]",[],"[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]",83.0,0.0223471,"Neurobehavioral recovery from TSD occurred after R1 and was maintained for all cognitive and self-reported measures, except for vigor.","[{'ForeName': 'Erika M', 'Initials': 'EM', 'LastName': 'Yamazaki', 'Affiliation': 'Biological Rhythms Research Laboratory, Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Antler', 'Affiliation': 'Biological Rhythms Research Laboratory, Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Charlotte R', 'Initials': 'CR', 'LastName': 'Lasek', 'Affiliation': 'Biological Rhythms Research Laboratory, Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Namni', 'Initials': 'N', 'LastName': 'Goel', 'Affiliation': 'Biological Rhythms Research Laboratory, Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, IL.'}]",Sleep,['10.1093/sleep/zsaa224'] 1624,33278020,Metabolic Effects of Aripiprazole and Olanzapine Multiple-Dose Treatment in a Randomised Crossover Clinical Trial in Healthy Volunteers: Association with Pharmacogenetics.,"INTRODUCTION Aripiprazole and olanzapine are atypical antipsychotics. Both drugs can induce metabolic changes; however, the metabolic side effects produced by aripiprazole are more benign. The aim of the study was to evaluate if aripiprazole and olanzapine alter prolactin levels, lipid and glucose metabolism and hepatic, haematological, thyroid and renal function. METHODS Twenty-four healthy volunteers received a daily oral dose of 10 mg aripiprazole and 5 mg olanzapine tablets for 5 days in a crossover randomised clinical trial and were genotyped for 51 polymorphisms in 18 genes by qPCR. Drug plasma concentrations were measured by LC-MS. The biochemical and haematological analyses were performed by enzymatic methods. RESULTS Olanzapine induced hyperprolactinaemia but aripiprazole did not. Dopamine D3 receptor (DRD3) Ser/Gly and ATP binding cassette subfamily B member 1 (ABCB1) rs10280101, rs12720067 and rs11983225 polymorphisms and cytochrome P450 3A (CYP3A) phenotype had an impact on plasma prolactin levels. C-peptide concentrations were higher after aripiprazole administration and were influenced by catechol-O-methyltransferase (COMT) rs4680 and rs13306278 polymorphisms. Olanzapine and the UDP glucuronosyltransferase family 1 member A1 (UGT1A1) rs887829 polymorphism were associated with elevated glucose levels. CYP3A poor metabolizers had increased insulin levels. Volunteers' weight decreased significantly during aripiprazole treatment and a tendency for weight gain was observed during olanzapine treatment. Triglyceride concentrations decreased as a result of olanzapine and aripiprazole treatment, and varied on the basis of CYP3A phenotypes and the apolipoprotein C-III (APOC3) rs4520 genotype. Cholesterol levels were also decreased and depended on 5-hydroxytryptamine receptor 2A (HTR2A) rs6314 polymorphism. All hepatic enzymes, platelet and albumin levels, and prothrombin time were altered during both treatments. Additionally, olanzapine reduced the leucocyte count, aripiprazole increased free T4 and both decreased uric acid concentrations. CONCLUSIONS Short-term treatment with aripiprazole and olanzapine had a significant influence on the metabolic parameters. However, it seems that aripiprazole provokes less severe metabolic changes. TRIAL REGISTRATION Clinical trial registration number (EUDRA-CT): 2018-000744-26.",2021,C-peptide concentrations were higher after aripiprazole administration and were influenced by catechol-O-methyltransferase (COMT) rs4680 and rs13306278 polymorphisms.,"['Twenty-four healthy volunteers', 'Healthy Volunteers']","['aripiprazole and olanzapine', 'UDP glucuronosyltransferase family\xa01 member\xa0A1 (UGT1A1', 'Aripiprazole and olanzapine', 'aripiprazole', 'Olanzapine', 'Aripiprazole and Olanzapine Multiple-Dose Treatment', 'aripiprazole and 5\xa0mg olanzapine tablets', 'olanzapine and aripiprazole', 'Dopamine D3 receptor', 'olanzapine']","['C-peptide concentrations', 'Drug plasma concentrations', 'All hepatic enzymes, platelet and albumin levels, and prothrombin time', 'leucocyte count, aripiprazole increased free T4 and both decreased uric acid concentrations', 'Triglyceride concentrations', 'elevated glucose levels', 'metabolic parameters', 'prolactin levels, lipid and glucose metabolism and hepatic, haematological, thyroid and renal function', 'insulin levels', 'weight gain', 'hyperprolactinaemia', ""Volunteers' weight"", 'Cholesterol levels', 'plasma prolactin levels']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0041560', 'cui_str': 'Glucuronosyltransferase'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1247204', 'cui_str': 'olanzapine Oral Tablet'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}]","[{'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0428321', 'cui_str': 'Measurement of liver enzyme'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0201838', 'cui_str': 'Albumin measurement'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0948241', 'cui_str': 'Thyroxine free increased'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0020514', 'cui_str': 'Hyperprolactinemia'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C1277971', 'cui_str': 'Plasma prolactin measurement'}]",24.0,0.0173305,C-peptide concentrations were higher after aripiprazole administration and were influenced by catechol-O-methyltransferase (COMT) rs4680 and rs13306278 polymorphisms.,"[{'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Koller', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, School of Medicine, Universidad Autónoma de Madrid, Instituto de Investigación Sanitaria La Princesa (IP), Madrid, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Almenara', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, School of Medicine, Universidad Autónoma de Madrid, Instituto de Investigación Sanitaria La Princesa (IP), Madrid, Spain.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Mejía', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, School of Medicine, Universidad Autónoma de Madrid, Instituto de Investigación Sanitaria La Princesa (IP), Madrid, Spain.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Saiz-Rodríguez', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, School of Medicine, Universidad Autónoma de Madrid, Instituto de Investigación Sanitaria La Princesa (IP), Madrid, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Zubiaur', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, School of Medicine, Universidad Autónoma de Madrid, Instituto de Investigación Sanitaria La Princesa (IP), Madrid, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Román', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, School of Medicine, Universidad Autónoma de Madrid, Instituto de Investigación Sanitaria La Princesa (IP), Madrid, Spain.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Ochoa', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, School of Medicine, Universidad Autónoma de Madrid, Instituto de Investigación Sanitaria La Princesa (IP), Madrid, Spain.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Navares-Gómez', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, School of Medicine, Universidad Autónoma de Madrid, Instituto de Investigación Sanitaria La Princesa (IP), Madrid, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Santos-Molina', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, School of Medicine, Universidad Autónoma de Madrid, Instituto de Investigación Sanitaria La Princesa (IP), Madrid, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Pintos-Sánchez', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, School of Medicine, Universidad Autónoma de Madrid, Instituto de Investigación Sanitaria La Princesa (IP), Madrid, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Abad-Santos', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, School of Medicine, Universidad Autónoma de Madrid, Instituto de Investigación Sanitaria La Princesa (IP), Madrid, Spain. francisco.abad@salud.madrid.org.'}]",Advances in therapy,['10.1007/s12325-020-01566-w'] 1625,33278016,Efficacy and Safety of Ixekizumab in Patients with Psoriatic Arthritis and Inadequate Response to TNF Inhibitors: 3-Year Follow-Up (SPIRIT-P2).,"PURPOSE Ixekizumab is a high-affinity monoclonal antibody that selectively targets interleukin-17A. The objective of this study was to assess the long-term efficacy and safety (to week 156) of ixekizumab in patients with active psoriatic arthritis and inadequate response or intolerance to one or two tumor necrosis factor inhibitors. METHODS In the SPIRIT-P2 study (ClinicalTrials.gov ID: NCT02349295), patients were randomized to placebo or ixekizumab 80 mg every 4 weeks (IXE Q4W) or every 2 weeks (IXE Q2W) following a 160-mg starting dose. During the extension period (weeks 24-156), patients maintained their original ixekizumab dose, and placebo patients received IXE Q4W or IXE Q2W (1:1). Exposure-adjusted incidence rates (IRs) per 100 patient-years (PY) are presented. RESULTS Of 363 patients enrolled in the study, 310 entered the extension period. In all patients treated with IXE Q4W and IXE Q2W at week 0, responses persisted to week 156. At week 156, clinical responses (observed) in patients treated with IXE Q4W and IXE Q2W were assessed [American College of Rheumatology (ACR) response criteria and minimal disease activity (MDA) criteria]: 84 and 85% showed 20% improvement (ACR20); 60 and 58% showed 50% improvement (ACR50); 35 and 47% showed 70% improvement (ACR70), respectively; and 48 and 54% showed MDA. Placebo patients re-randomized to ixekizumab also demonstrated sustained efficacy, as measured by ACR and MDA responses. In the All Ixekizumab Exposure Safety Population (n = 337), with 644 PY of ixekizumab exposure, treatment-emergent adverse events (TEAEs) were reported by 286 patients (44.4 IR). The most common TEAEs were upper respiratory tract infection (9.80 IR), nasopharyngitis (8.2 IR), sinusitis (6.2 IR), and bronchitis (4.5 IR). Serious adverse events were reported by 42 (6.5 IR) patients (included 3 deaths and 10 infections). CONCLUSION In this 156-week study of ixekizumab, improvements in signs and symptoms of psoriatic arthritis and the safety profile remained consistent with those in previous reports. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT02349295.",2021,"At week 156, clinical responses (observed) in patients treated with IXE Q4W and IXE Q2W were assessed [American College of Rheumatology (ACR) response criteria and minimal disease activity (MDA) criteria]: 84 and 85% showed 20% improvement (ACR20); 60 and 58% showed 50% improvement (ACR50); 35 and 47% showed 70% improvement (ACR70), respectively; and 48 and 54% showed MDA.","['363 patients enrolled in the study', 'patients with active psoriatic arthritis and inadequate response or intolerance to one or two tumor necrosis factor inhibitors', 'Patients with Psoriatic Arthritis and Inadequate Response to TNF Inhibitors']","['80\xa0mg every 4\xa0weeks (IXE Q4W) or every 2\xa0weeks (IXE Q2W', 'placebo patients received IXE Q4W or IXE Q2W (1:1', 'placebo or ixekizumab', 'Ixekizumab', 'ixekizumab', 'IXE Q4W and IXE Q2W', 'Placebo', 'interleukin-17A']","['long-term efficacy and safety', 'assessed [American College of Rheumatology (ACR) response criteria and minimal disease activity', 'signs and symptoms of psoriatic arthritis', 'upper respiratory tract infection (9.80 IR), nasopharyngitis (8.2 IR), sinusitis (6.2 IR), and bronchitis', 'Serious adverse events', 'ACR and MDA responses', 'Efficacy and Safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C3537192', 'cui_str': 'TNF Antagonists'}]","[{'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0037199', 'cui_str': 'Sinusitis'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0006277', 'cui_str': 'Bronchitis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",363.0,0.138668,"At week 156, clinical responses (observed) in patients treated with IXE Q4W and IXE Q2W were assessed [American College of Rheumatology (ACR) response criteria and minimal disease activity (MDA) criteria]: 84 and 85% showed 20% improvement (ACR20); 60 and 58% showed 50% improvement (ACR50); 35 and 47% showed 70% improvement (ACR70), respectively; and 48 and 54% showed MDA.","[{'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Orbai', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA. aorbai1@jhmi.edu.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Gratacós', 'Affiliation': 'Rheumatology Department, Hospital Universitari Parc Taulí, Sabadell, Barcelona, Spain.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Turkiewicz', 'Affiliation': 'Rheumatology Associates Clinical Research Unit, Birmingham, AL, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Hall', 'Affiliation': 'Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Dokoupilova', 'Affiliation': 'Medical Plus, s.r.o., Uherské Hradiště, Czech Republic.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Combe', 'Affiliation': 'CHU Montpellier and Montpellier University, Montpellier, France.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nash', 'Affiliation': 'School of Medicine, Griffith University, Brisbane, Australia.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Gallo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Clinton C', 'Initials': 'CC', 'LastName': 'Bertram', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Gellett', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Aubrey Trevelin', 'Initials': 'AT', 'LastName': 'Sprabery', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Birt', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Macpherson', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Vladimir J', 'Initials': 'VJ', 'LastName': 'Geneus', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Constantin', 'Affiliation': 'Hospital Pierre-Paul Riquet and Université Toulouse III, Toulouse, France.'}]",Rheumatology and therapy,['10.1007/s40744-020-00261-0'] 1626,33278014,Evidence from a Randomized Controlled Trial that Altruism Moderates the Effect of Prosocial Acts on Adolescent Well-being.,"Despite growing public and scientific interest in the positive benefits of prosociality, there has been little research on the causal effects of performing kind acts for others on psychological well-being during adolescence. Developmental changes during adolescence, such as greater perspective taking, can promote prosociality. It was hypothesized that performing kind acts for others would improve adolescent well-being (positive and negative affect, perceived stress) and increase prosocial giving. As part of a randomized controlled trial, 97 adolescents (M age  = 16.224, SD = 0.816, range 14-17; 53.608% female) were assigned to either perform kind acts for others (Kindness to Others, N = 33), perform kind acts for themselves (Kindness to Self, N = 34), or report on daily activities (Daily Report, N = 30) three times per week for four weeks. Well-being factors were measured weekly and giving was tested post-intervention. Overall, changes over time in well-being did not differ across conditions. However, altruism emerged as a significant moderator such that altruistic adolescents in the Kindness to Others condition showed increased positive affect, decreased negative affect, and decreased stress. Increased positive affect was also linked to greater prosocial giving for Kindness to Others adolescents. These findings identify individual differences that may shape the effects of doing kind acts for others on well-being during adolescence.",2021,"Overall, changes over time in well-being did not differ across conditions.","['97 adolescents (M age\u2009 =\u200916.224, SD\u2009=\u20090.816, range 14-17; 53.608% female', '30', 'Adolescent']","['Prosocial Acts', 'perform kind acts for themselves (Kindness to Self, N\u2009=\u200934), or report on daily activities (Daily Report, N\u2009']",['stress'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}]",97.0,0.0917603,"Overall, changes over time in well-being did not differ across conditions.","[{'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Tashjian', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA, 90095, USA. smtashjian@ucla.edu.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Rahal', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Maira', 'Initials': 'M', 'LastName': 'Karan', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Eisenberger', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Galván', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Steve W', 'Initials': 'SW', 'LastName': 'Cole', 'Affiliation': 'Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Fuligni', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA, 90095, USA. afuligni@ucla.edu.'}]",Journal of youth and adolescence,['10.1007/s10964-020-01362-3'] 1627,33278292,Transcutaneous Electrical Nerve Stimulation to Reduce Pain With Medication Abortion: A Randomized Controlled Trial.,"OBJECTIVE To evaluate whether high-frequency transcutaneous electrical nerve stimulation (hfTENS) reduces pain during medication abortion. METHODS We conducted a randomized, placebo-controlled trial. Participants who were undergoing medication abortion with mifepristone and misoprostol through 70 days of gestation either received active 80 Hz hfTENS or sham to use for a minimum of 60 minutes within 8 hours of misoprostol. Maximum pain on an 11-point numerical rating scale at 8 hours after misoprostol was the primary outcome. We estimated 20 per group for 80% power to detect a 2-point difference and up to 10% attrition. Secondary outcomes included a maximum pain score at 24 hours, additional analgesia use, the difference in score before and after treatment, the experience of side effects, abortion outcomes, and acceptability. We collected data at baseline, time of misoprostol (0-hour), 8-hour and 24 hours using real-time electronic surveys, and at follow-up. RESULTS Between June 2019 and March 2020, we screened 251 patients and randomized 40-20 each to hfTENS or sham-with one postrandomization exclusion and two patients lost to follow-up. Baseline characteristics were similar. Median maximum pain scores at 8 hours were 7.0 (interquartile range 3.0) and 10.0 (interquartile range 3.0) for hfTENS and sham, respectively. The distribution of these scores was lower among hfTENS users compared with sham (mean rank 15.17 vs 22.63, P=.036). High-frequency TENS users also experienced a significant reduction in posttreatment pain score (-2.0 [interquartile range 2.5] vs 0 [interquartile range 1.5], P=.008). We found no statistically significant differences in use of additional analgesia, distribution of maximum pain scores at 24 hours, side effects, or measures of acceptability. CONCLUSION High-frequency TENS reduced maximum pain scores within 8 hours of misoprostol and reduced pain scores immediately after treatment compared with placebo. High-frequency TENS offers an effective nonpharmacologic option for pain management during medication abortion. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, NCT03925129.",2021,"We found no statistically significant differences in use of additional analgesia, distribution of maximum pain scores at 24 hours, side effects, or measures of acceptability. ","['With Medication Abortion', 'Between June 2019 and March 2020, we screened 251 patients and randomized 40-20 each to', 'through 70 days of gestation either received', 'Participants who were undergoing medication abortion with']","['high-frequency transcutaneous electrical nerve stimulation (hfTENS', 'placebo', 'misoprostol', 'hfTENS or sham-with one postrandomization exclusion', 'mifepristone and misoprostol', 'Transcutaneous Electrical Nerve Stimulation', 'active 80 Hz hfTENS or sham']","['Maximum pain', 'posttreatment pain score', 'Median maximum pain scores', 'additional analgesia, distribution of maximum pain scores', 'maximum pain score at 24 hours, additional analgesia use, the difference in score before and after treatment, the experience of side effects, abortion outcomes, and acceptability', '11-point numerical rating scale', 'Pain', 'maximum pain scores', 'pain scores', 'side effects, or measures of acceptability']","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1457900', 'cui_str': 'Each'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1291733', 'cui_str': 'Posttreatment pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",251.0,0.75782,"We found no statistically significant differences in use of additional analgesia, distribution of maximum pain scores at 24 hours, side effects, or measures of acceptability. ","[{'ForeName': 'Ariella R', 'Initials': 'AR', 'LastName': 'Goldman', 'Affiliation': 'Icahn School of Medicine at Mount Sinai and Planned Parenthood of Greater New York, New York, New York.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Porsch', 'Affiliation': ''}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Hintermeister', 'Affiliation': ''}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Dragoman', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004208'] 1628,33278291,Preoperative Pelvic Floor Injections With Bupivacaine and Dexamethasone for Pain Control After Vaginal Prolapse Repair: A Randomized Controlled Trial.,"OBJECTIVE To test the hypothesis that preoperative pelvic floor muscle injections and pudendal nerve blocks with bupivacaine and dexamethasone would decrease postoperative pain after vaginal native tissue prolapse repairs, compared with saline and bupivacaine. METHODS We conducted a three-arm, double-blind, randomized trial of bilateral transobturator levator ani muscle injections and transvaginal pudendal nerve blocks before vaginal reconstructive and obliterative prolapse procedures (uterosacral ligament suspension, sacrospinous ligament fixation, levator myorrhaphy, or colpocleisis). Women were randomized to one of three study medication groups: 0.9% saline, 0.25% bupivacaine, or combination 0.25% bupivacaine with 4 mg dexamethasone. Our primary outcome was a numeric rating scale pain score on postoperative day 1. Using an analysis of variance evaluated at the two-sided 0.05 significance level, an assumed variance of the means of 0.67, and SD of 1.75, we calculated 21 women per arm to detect a 2-point change on the numeric rating scale (90% power), which we increased to 25 per arm to account for 20% attrition and the use of nonparametric statistical methods. RESULTS From June 2017 through April 2019, 281 women were screened and 75 (26.7%) were randomized with no differences in baseline demographics among study arms. There was no significant difference in median pain scores on postoperative day 1 among study groups (median [interquartile range] pain score 4.0 [2.0-7.0] for placebo vs 4.0 [2.0-5.5] for bupivacaine vs 4.0 [1.5-5.0] for bupivacaine with dexamethasone, P=.92). CONCLUSION Preoperative pelvic floor muscle injections and pudendal nerve blocks with bupivacaine and dexamethasone did not improve postoperative pain after vaginal native tissue prolapse procedures. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, NCT03040011.",2021,"There was no significant difference in median pain scores on postoperative day 1 among study groups (median [interquartile range] pain score 4.0 [2.0-7.0] for placebo vs 4.0 [2.0-5.5] for bupivacaine vs 4.0 [1.5-5.0] for bupivacaine with dexamethasone, P=.92). ","['after vaginal native tissue prolapse repairs', 'after vaginal native tissue prolapse procedures', 'After Vaginal Prolapse Repair', 'From June 2017 through April 2019, 281 women were screened and 75 (26.7']","['saline and bupivacaine', 'placebo', 'bupivacaine', 'saline, 0.25% bupivacaine, or combination 0.25% bupivacaine with 4 mg dexamethasone', 'bilateral transobturator levator ani muscle injections and transvaginal pudendal nerve blocks before vaginal reconstructive and obliterative prolapse procedures (uterosacral ligament suspension, sacrospinous ligament fixation, levator myorrhaphy, or colpocleisis', 'bupivacaine and dexamethasone', 'Bupivacaine and Dexamethasone']","['Pain Control', 'median pain scores', 'postoperative pain', 'pain score', 'numeric rating scale pain score', 'numeric rating scale']","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0856413', 'cui_str': 'Prolapse repair'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C2938890', 'cui_str': 'Vaginal prolapse repair'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0224384', 'cui_str': 'Structure of levator ani muscle'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach'}, {'cui': 'C0394776', 'cui_str': 'Injection of anesthetic agent into pudendal nerve'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0439676', 'cui_str': 'Obliterative'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0230306', 'cui_str': 'Structure of uterosacral ligament'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0225049', 'cui_str': 'Structure of sacrospinous ligament'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0027094', 'cui_str': 'Suture of muscle'}, {'cui': 'C0195191', 'cui_str': 'Complete colpocleisis'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",281.0,0.615901,"There was no significant difference in median pain scores on postoperative day 1 among study groups (median [interquartile range] pain score 4.0 [2.0-7.0] for placebo vs 4.0 [2.0-5.5] for bupivacaine vs 4.0 [1.5-5.0] for bupivacaine with dexamethasone, P=.92). ","[{'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Giugale', 'Affiliation': 'Division of Urogynecology and Pelvic Floor Reconstructive Surgery, Magee-Womens Hospital of UPMC, the University of Pittsburgh School of Medicine, the Department of Anesthesiology, Magee-Womens Hospital of UPMC, the Department of Anesthesiology, UPMC, and the Magee-Womens Research Institute, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Lindsey A', 'Initials': 'LA', 'LastName': 'Baranski', 'Affiliation': ''}, {'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'Meyn', 'Affiliation': ''}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Schott', 'Affiliation': ''}, {'ForeName': 'Trent D', 'Initials': 'TD', 'LastName': 'Emerick', 'Affiliation': ''}, {'ForeName': 'Pamela A', 'Initials': 'PA', 'LastName': 'Moalli', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004205'] 1629,33278290,Foley Bulb Insertion by Blind Placement Compared With Direct Visualization: A Randomized Controlled Trial.,"OBJECTIVE To test the hypothesis that digital placement of a balloon catheter is not inferior to the speculum method in terms of rate of maternal infection. METHODS In an open-label noninferiority randomized trial, pregnant women who were undergoing induction of labor with unfavorable cervix (less than 3 cm dilated and less than 60% effaced) were randomly assigned to balloon catheter that was placed either digitally or using a sterile speculum. The primary outcome was a composite of maternal infection, defined by occurrence of fever (temperature 38°C or higher), chorioamnionitis, or endometritis (diagnoses were made by the managing obstetric physician or midwife). Prespecified secondary outcomes included outcomes in the primary composite, cesarean delivery rates, and maternal and neonatal outcomes. A patient satisfaction survey was also obtained. On the basis of a noninferiority margin of 10% and an expected primary outcome frequency of 10%, a sample size of 372 women was needed (90% power to confirm noninferiority with 90% protocol adherence). RESULTS From February 2018 through February 2019, 372 women were randomized (185 digital placement, 187 sterile speculum). Baseline characteristics were similar between groups. The composite maternal infection rate was not different between groups (digital placement arm: 15.7% vs speculum arm: 12.8%), with an absolute difference with respect to the sterile speculum arm of 2.8% (95% CI -4.3 to 9.9%), indicating noninferiority for the prespecified margin. Secondary outcomes were not different between groups, except for a higher need for a second balloon catheter in the sterile speculum arm. Maternal and neonatal adverse events were not different between groups. Irrespective of method of placement, women were equally satisfied with the explanation of the method before placement, anxiety regarding the procedure, and pain during placement. More women in the sterile speculum group would choose the digital placement method for the subsequent pregnancy (37.6% vs 25.7%; P=.02.). CONCLUSION Digital placement of a balloon catheter for preinduction cervical ripening is noninferior to the sterile speculum method, in terms of maternal infection. Women in the sterile speculum group more frequently required a second round of the mechanical dilator. The blind digital approach is a reasonable option for balloon placement for cervical ripening. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, NCT03450408.",2021,"Secondary outcomes were not different between groups, except for a higher need for a second balloon catheter in the sterile speculum arm.","['372 women', 'From February 2018 through February 2019, 372 women were randomized (185 digital placement, 187 sterile speculum', 'pregnant women who were undergoing induction of labor with unfavorable cervix (less than 3 cm dilated and less than 60% effaced']","['balloon catheter that was placed either digitally or using a sterile speculum', 'Foley Bulb Insertion by Blind Placement', 'Direct Visualization']","['Maternal and neonatal adverse events', 'primary composite, cesarean delivery rates, and maternal and neonatal outcomes', 'composite maternal infection rate', 'composite of maternal infection, defined by occurrence of fever (temperature 38°C or higher), chorioamnionitis, or endometritis (diagnoses were made by the managing obstetric physician or midwife']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0037816', 'cui_str': 'Speculum'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0007874', 'cui_str': 'Cervix uteri structure'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0700124', 'cui_str': 'Ectatic'}]","[{'cui': 'C0441127', 'cui_str': 'Balloon dilatation catheter'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0037816', 'cui_str': 'Speculum'}, {'cui': 'C0025148', 'cui_str': 'Medulla oblongata structure'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0239997', 'cui_str': 'Maternal infection'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0008495', 'cui_str': 'Chorioamnionitis'}, {'cui': 'C0014179', 'cui_str': 'Endometritis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}]",372.0,0.381179,"Secondary outcomes were not different between groups, except for a higher need for a second balloon catheter in the sterile speculum arm.","[{'ForeName': 'Maggie J', 'Initials': 'MJ', 'LastName': 'Kuhlmann', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Spencer', 'Affiliation': ''}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Garcia-Jasso', 'Affiliation': ''}, {'ForeName': 'Prapti', 'Initials': 'P', 'LastName': 'Singh', 'Affiliation': ''}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Abdelwahab', 'Affiliation': ''}, {'ForeName': 'Micah', 'Initials': 'M', 'LastName': 'Vaughn', 'Affiliation': ''}, {'ForeName': 'Karis', 'Initials': 'K', 'LastName': 'Marshall', 'Affiliation': ''}, {'ForeName': 'Nikita', 'Initials': 'N', 'LastName': 'Prasad', 'Affiliation': ''}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Soulsby-Monroy', 'Affiliation': ''}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Saade', 'Affiliation': ''}, {'ForeName': 'Antonio F', 'Initials': 'AF', 'LastName': 'Saad', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004182'] 1630,33278280,Racial Disparities in Mental Health Outcomes Among Women With Early Pregnancy Loss.,"OBJECTIVE To explore the relationship between race and depression symptoms among participants in an early pregnancy loss clinical trial. METHODS We performed a planned secondary analysis of a randomized trial by comparing treatments for medical management of early pregnancy loss. We hypothesized that Black participants would have higher odds of risk for major depression (measured with the CES-D [Center for Epidemiological Studies-Depression] scale) 30 days after early pregnancy loss treatment when compared with non-Black participants. We analyzed the data as a cohort, with the primary exposure being race and secondary exposure being high adverse childhood experience scores (measured with the Adverse Childhood Experience scale). Our primary outcome was risk for major depression (score of 21 or higher on the CES-D scale) 30 days after early pregnancy loss treatment. RESULTS Three hundred participants diagnosed with a nonviable intrauterine pregnancy from 5 to 12 weeks of gestation were randomized as part of the original trial from May 2014 to April 2017. Of 275 respondents included in this analysis, 120 [44%] self-identified as Black and 155 [56%] self-identified as non-Black. After early pregnancy loss treatment, 65 [24%] participants were at risk for major depression. Black participants had an increased risk for major depression (57%) after early pregnancy loss treatment compared with non-Black participants (43%; odds ratio [OR] 2.02; 95% CI 1.15-3.55). After adjustment for risk for baseline depression, adverse childhood experience score, and parity, the odds of risk for major depression 30 days after pregnancy loss treatment remained higher for Black participants when compared with non-Black participants (OR 2.02; 95% CI 1.15-3.55; adjusted OR 2.48; 95% CI 1.28-4.81). CONCLUSION Overall, approximately one quarter of women who experience an early pregnancy loss are at an increased risk for major depression 30 days after treatment. This risk is about twice as high for Black women compared with non-Black women. There is a need for appropriate mental health resources for women undergoing early pregnancy loss care. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, NCT02012491.",2021,Black participants had an increased risk for major depression (57%) after early pregnancy loss treatment compared with non-Black participants (43%; odds ratio [OR] 2.02; 95% CI 1.15-3.55).,"['medical management of early pregnancy loss', 'Black participants', 'Black women compared with non-Black women', 'Three hundred participants diagnosed with a nonviable intrauterine pregnancy from 5 to 12 weeks of gestation', 'Of 275 respondents included in this analysis, 120 [44%] self-identified as Black and 155 [56%] self-identified as non-Black', 'women undergoing early pregnancy loss care', 'Women With Early Pregnancy Loss', 'participants in an early pregnancy loss clinical trial']",[],"['adverse childhood experience score, and parity, the odds of risk for major depression 30 days after pregnancy loss treatment', 'risk for major depression', 'early pregnancy loss']","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C3830362', 'cui_str': 'Early Pregnancy Loss'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0149973', 'cui_str': 'Intrauterine pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C4296616', 'cui_str': 'Adverse Childhood Experiences'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0156543', 'cui_str': 'Pregnancy with abortive outcome'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3830362', 'cui_str': 'Early Pregnancy Loss'}]",300.0,0.281452,Black participants had an increased risk for major depression (57%) after early pregnancy loss treatment compared with non-Black participants (43%; odds ratio [OR] 2.02; 95% CI 1.15-3.55).,"[{'ForeName': 'Jade M', 'Initials': 'JM', 'LastName': 'Shorter', 'Affiliation': 'Departments of Obstetrics and Gynecology and Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania; and the Department of Biostatistics and Informatics, Colorado School of Public Health, Aurora, Colorado.'}, {'ForeName': 'Nathanael', 'Initials': 'N', 'LastName': 'Koelper', 'Affiliation': ''}, {'ForeName': 'Sarita', 'Initials': 'S', 'LastName': 'Sonalkar', 'Affiliation': ''}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Oquendo', 'Affiliation': ''}, {'ForeName': 'Mary D', 'Initials': 'MD', 'LastName': 'Sammel', 'Affiliation': ''}, {'ForeName': 'Courtney A', 'Initials': 'CA', 'LastName': 'Schreiber', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004212'] 1631,33283766,Efficacy and safety of 7 days versus 10 days triple therapy based on levofloxacin-dexlansoprazole for eradication of Helicobacter pylori : A pilot randomized trial.,"BACKGROUND Levofloxacin-based triple therapies are considered the standard regimen for eradication of Helicobacter pylori (H. pylori) due to decreased sensitivity to clarithromycin and the optimal duration of therapy is still controversial. Besides, there is no complete evidence about dexlansoprazole efficacy in the eradication of H. pylori. AIM Our study aimed to determine the effectiveness of triple therapy based on levofloxacin-dexlansoprazole as a standard treatment for H. pylori infection and estimate the effect of H. pylori on lipid profile and hemoglobin (Hb). MATERIALS AND METHODS A pilot prospective randomized trial of a triple therapy based on levofloxacin-dexlansoprazole for H. pylori eradication was conducted at Damanhour Medical National Institute, Egypt; 66 participants with H. pylori infection received levofloxacin (500 mg/day) plus amoxicillin (1 g/12 h) plus dexlansoprazole (60 mg/day). All medications administrated orally for either 7 days or 10 days. Four weeks after treatment, the eradication was assessed by the stool antigen test. RESULTS The rate of eradication was 63.6% in levofloxacin, amoxicillin, and dexlansoprazole (LAD) 7-day group, and 90.9% in LAD 10-day group. In addition, laboratory test results showed a significant difference in Hb, low-density lipoprotein, high-density lipoprotein, triglyceride, and total cholesterol levels before and after treatment (P < 0.05). CONCLUSION LAD 10 days is the least duration that provides maximum efficacy for H. pylori in Egyptian participants. In addition, successful treatment of H. pylori infection may reduce the risk of anemia and dyslipidemia. Furthermore, all members of the patient's family should be screened for H. pylori to prevent recurrent infection.",2020,"The rate of eradication was 63.6% in levofloxacin, amoxicillin, and dexlansoprazole (LAD) 7-day group, and 90.9% in LAD 10-day group.","['Egyptian participants', 'Damanhour Medical National Institute, Egypt; 66 participants with H. pylori infection received', 'Helicobacter pylori ']","['levofloxacin-dexlansoprazole', 'dexlansoprazole', 'levofloxacin', 'levofloxacin, amoxicillin, and dexlansoprazole', 'amoxicillin', 'Levofloxacin', 'clarithromycin']","['rate of eradication', 'lipid profile and hemoglobin (Hb', 'Efficacy and safety', 'Hb, low-density lipoprotein, high-density lipoprotein, triglyceride, and total cholesterol levels', 'risk of anemia and dyslipidemia']","[{'cui': 'C0013717', 'cui_str': 'Egyptian language'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}]","[{'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C2348248', 'cui_str': 'dexlansoprazole'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}]",66.0,0.0458075,"The rate of eradication was 63.6% in levofloxacin, amoxicillin, and dexlansoprazole (LAD) 7-day group, and 90.9% in LAD 10-day group.","[{'ForeName': 'Noha Mahmoud', 'Initials': 'NM', 'LastName': 'Elkhodary', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, Damanhour University, Damanhour, Egypt.'}, {'ForeName': 'Khaled Abdalkader', 'Initials': 'KA', 'LastName': 'Farrag', 'Affiliation': 'Tropical Medicine and Hygiene Department, Damanhour Medical National Institute, Damanhour, Egypt.'}, {'ForeName': 'Amany Mahmoud', 'Initials': 'AM', 'LastName': 'Elokaby', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, Damanhour University, Damanhour, Egypt.'}, {'ForeName': 'Gamal Abd', 'Initials': 'GA', 'LastName': 'El-Hay Omran', 'Affiliation': 'Department of Biochemistry, Faculty of Pharmacy, Damanhour University, Damanhour, Egypt.'}]",Indian journal of pharmacology,['10.4103/ijp.IJP_364_19'] 1632,33279155,Comments on clinical behavior of posterior fixed partial dentures with a biologically oriented preparation technique: A 5-year randomized controlled clinical trial.,,2021,,[],[],[],[],[],[],,0.185111,,"[{'ForeName': 'Momina Anees', 'Initials': 'MA', 'LastName': 'Motiwala', 'Affiliation': 'Resident, Operative Dentistry, Department of Surgery, Aga Khan University, Karachi, PAKISTAN.'}, {'ForeName': 'Farhan Raza', 'Initials': 'FR', 'LastName': 'Khan', 'Affiliation': 'Associate Professor, Operative Dentistry, Department of Surgery, Aga Khan University, Karachi, PAKISTAN.'}]",The Journal of prosthetic dentistry,['10.1016/j.prosdent.2020.07.035'] 1633,33284423,Ixekizumab Improves Patient-Reported Outcomes in Non-Radiographic Axial Spondyloarthritis: Results from the Coast-X Trial.,"INTRODUCTION Ixekizumab, an interleukin-17A antibody, has shown efficacy in non-radiographic axial spondyloarthritis (nr-axSpA). The objectives of this analysis were (a) to measure improvement in ixekizumab-treated patients in Assessment of Spondyloarthritis International Society (ASAS) response domains and other patient-reported outcomes (PROs) and (b) to determine how ASAS responses were associated with changes in patient global disease activity (PtGA), spinal pain, function, stiffness, fatigue, and spinal pain at night. METHODS COAST-X was a phase 3, 52-week multicenter, randomized, controlled trial investigating the efficacy and safety of 80-mg ixekizumab every 2 weeks (Q2W) and every 4 weeks (Q4W) in patients with active nr-axSpA. Changes from baseline in PROs were analyzed via mixed-effects models for repeated measures. Association analyses for ASAS responses used analysis of covariance with Scheffé's method. RESULTS Patients treated with ixekizumab Q2W and Q4W reported significantly greater improvements in PtGA, spinal pain, function, and stiffness at week 1, when these measures were first assessed, compared with placebo (p < 0.05). ASAS40 responders, in comparison to ASAS20 non-responders, had the highest correlations with improvements in all response domains (PtGA, spinal pain, function, and stiffness) as well as fatigue and spinal pain at night (p < 0.001). ASAS40 responses were associated with 3.5- to 48.0-fold greater improvements in these PROs, with the highest values for PtGA and function, compared to ASAS20 non-achievement. CONCLUSIONS As early as week 1, patients with nr-axSpA treated with ixekizumab reported significant improvements in PtGA, spinal pain, function, and stiffness compared with those taking placebo. ASAS40 responders reported significantly greater improvements in all ASAS response domains (PtGA, spinal pain, function, and stiffness) as well as fatigue and spinal pain at night than ASAS20 non-responders. Improvements in PtGA and function appear to be major drivers in achieving ASAS40 response in patients with nr-axSpA. TRIAL REGISTRATION NCT02757352.",2021,"responders reported significantly greater improvements in all ASAS response domains (PtGA, spinal pain, function, and stiffness) as well as fatigue and spinal pain at night than ASAS20",['patients with active nr-axSpA. Changes from baseline in PROs'],"['placebo', '80-mg ixekizumab', 'ASAS40', 'Ixekizumab', 'ASAS20', 'ixekizumab Q2W and Q4W', 'placebo. ASAS40']","['response domains (PtGA, spinal pain, function, and stiffness) as well as fatigue and spinal pain at night', 'ASAS response domains (PtGA, spinal pain, function, and stiffness) as well as fatigue and spinal pain', 'PtGA, spinal pain, function, and stiffness', 'efficacy and safety', 'patient global disease activity (PtGA), spinal pain, function, stiffness, fatigue, and spinal pain at night']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C3889038', 'cui_str': 'Non-radiographic axial spondyloarthritis'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3489764', 'cui_str': 'ixekizumab'}]","[{'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0423673', 'cui_str': 'Pain in spine'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0949690', 'cui_str': 'Arthritis of spine'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0832877,"responders reported significantly greater improvements in all ASAS response domains (PtGA, spinal pain, function, and stiffness) as well as fatigue and spinal pain at night than ASAS20","[{'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Deodhar', 'Affiliation': 'Division of Arthritis and Rheumatic Diseases, Oregon Health and Science University, Portland, OR, USA. deodhara@ohsu.edu.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Mease', 'Affiliation': 'Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Proton', 'Initials': 'P', 'LastName': 'Rahman', 'Affiliation': ""Memorial University of Newfoundland, St. John's, NL, Canada.""}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Navarro-Compán', 'Affiliation': 'Hospital Universitario La Paz, IdiPaz, Madrid, Spain.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Marzo-Ortega', 'Affiliation': 'NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals Trust and LIRMM, University of Leeds, Leeds, WY, UK.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Hunter', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sandoval', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Andris', 'Initials': 'A', 'LastName': 'Kronbergs', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Leon', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Mingyang', 'Initials': 'M', 'LastName': 'Shan', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Leung', 'Affiliation': 'Syneos Health, Morrisville, NC, USA.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'De Vlam', 'Affiliation': 'Department of Rheumatology, Universitaire Ziekenhuizen Leuven, Leuven, Belgium.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Strand', 'Affiliation': 'Division of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, CA, USA.'}]",Rheumatology and therapy,['10.1007/s40744-020-00254-z'] 1634,33293077,Extended Versus Limited Pelvic Lymph Node Dissection During Radical Prostatectomy for Intermediate- and High-risk Prostate Cancer: Early Oncological Outcomes from a Randomized Phase 3 Trial.,"BACKGROUND The role of extended pelvic lymph node dissection (EPLND) in the surgical management of prostate cancer (PCa) patients remains controversial, mainly because of a lack of randomized controlled trials (RCTs). OBJECTIVE To determine whether EPLND has better oncological outcomes than limited PLND (LPLND. DESIGN, SETTING AND PARTICIPANTS This was a prospective, single-center phase 3 trial in patients with intermediate- or high-risk clinically localized PCa. INTERVENTION Randomization (1:1) to LPLND (obturator nodes) or EPLND (obturator, external iliac, internal iliac, common iliac, and presacral nodes) bilaterally. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS The primary endpoint was biochemical recurrence-free survival (BRFS). Secondary outcomes were metastasis-free survival (MFS), cancer-specific survival (CSS), and histopathological findings. The trial was designed to show a minimal 15% advantage in 5-yr BRFS by EPLND. RESULTS AND LIMITATIONS In total, 300 patients were randomized from May 2012 to December 2016 (150 LPLND and 150 EPLND). The median BRFS was 61.4 mo in the LPLND group and not reached in the EPLND group (hazard ratio [HR] 0.91, 95% confidence interval [CI] 0.63-1.32; p =  0.6). Median MFS was not reached in either group (HR 0.57, 95% CI 0.17-1.8; p =  0.3). CSS data were not available because no patient died from PCa before the cutoff date. In exploratory subgroup analysis, patients with preoperative biopsy International Society of Urological Pathology (ISUP) grade groups 3-5 who were allocated to EPLND had better BRFS (HR 0.33, 95% CI 0.14-0.74, interaction p =  0.007). The short follow-up and surgeon heterogeneity are limitations to this study. CONCLUSION This RCT confirms that EPLND provides better pathological staging, while differences in early oncological outcomes were not demonstrated. Our subgroup analysis suggests a potential BCRFS benefit in patients diagnosed with ISUP grade groups 3-5; however, these findings should be considered hypothesis-generating and further RCTs with larger cohorts and longer follow up are necessary to better define the role of EPLND during RP. PATIENT SUMMARY In this study, we investigated early outcomes in prostate cancer patients undergoing prostatectomy according to the anatomic extent of lymph node resection. We found that extended removal of lymph nodes did not reduce biochemical recurrence of prostate cancer in the expected range.",2021,"Median MFS was not reached in either group (HR 0.57, 95% CI 0.17-1.8; p =  0.3).","['patients with intermediate- or high-risk clinically localized PCa', 'prostate cancer patients undergoing prostatectomy according to the anatomic extent of lymph node resection', 'prostate cancer (PCa) patients', 'for Intermediate- and High-risk Prostate Cancer', 'patients with preoperative biopsy International Society of Urological Pathology (ISUP) grade groups 3-5 who were allocated to', '300 patients were randomized from May 2012 to December 2016 (150 LPLND and 150 EPLND']","['EPLND', 'LPLND', 'extended pelvic lymph node dissection (EPLND', 'Pelvic Lymph Node Dissection During Radical Prostatectomy', 'LPLND (obturator nodes) or EPLND (obturator, external iliac, internal iliac, common iliac, and presacral nodes) bilaterally']","['metastasis-free survival (MFS), cancer-specific survival (CSS), and histopathological findings', 'BRFS', 'median BRFS', 'Median MFS', 'biochemical recurrence of prostate cancer', 'biochemical recurrence-free survival (BRFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0332326', 'cui_str': 'Gleason grading system for prostatic cancer'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0193883', 'cui_str': 'Pelvic lymphadenectomy'}]","[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0193883', 'cui_str': 'Pelvic lymphadenectomy'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0229822', 'cui_str': 'Obturator lymph node group'}, {'cui': 'C0182021', 'cui_str': 'Obturator'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0020889', 'cui_str': 'Bone structure of ilium'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0205214', 'cui_str': 'Common'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]",300.0,0.308275,"Median MFS was not reached in either group (HR 0.57, 95% CI 0.17-1.8; p =  0.3).","[{'ForeName': 'Jean F P', 'Initials': 'JFP', 'LastName': 'Lestingi', 'Affiliation': 'Instituto do Cancer do Estado de Sao Paulo, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil. Electronic address: jeanlestingi@gmail.com.'}, {'ForeName': 'Giuliano B', 'Initials': 'GB', 'LastName': 'Guglielmetti', 'Affiliation': 'Instituto do Cancer do Estado de Sao Paulo, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Quoc-Dien', 'Initials': 'QD', 'LastName': 'Trinh', 'Affiliation': ""Dana-Farber Cancer Institute, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Rafael F', 'Initials': 'RF', 'LastName': 'Coelho', 'Affiliation': 'Instituto do Cancer do Estado de Sao Paulo, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Pontes', 'Affiliation': 'Instituto do Cancer do Estado de Sao Paulo, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Diogo A', 'Initials': 'DA', 'LastName': 'Bastos', 'Affiliation': 'Instituto do Cancer do Estado de Sao Paulo, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Mauricio D', 'Initials': 'MD', 'LastName': 'Cordeiro', 'Affiliation': 'Instituto do Cancer do Estado de Sao Paulo, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Alvaro S', 'Initials': 'AS', 'LastName': 'Sarkis', 'Affiliation': 'Instituto do Cancer do Estado de Sao Paulo, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Sheila F', 'Initials': 'SF', 'LastName': 'Faraj', 'Affiliation': 'Instituto do Cancer do Estado de Sao Paulo, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Anuar I', 'Initials': 'AI', 'LastName': 'Mitre', 'Affiliation': 'Instituto do Cancer do Estado de Sao Paulo, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Srougi', 'Affiliation': 'Instituto do Cancer do Estado de Sao Paulo, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Nahas', 'Affiliation': 'Instituto do Cancer do Estado de Sao Paulo, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.'}]",European urology,['10.1016/j.eururo.2020.11.040'] 1635,33306589,"Resistance Training to Failure vs. Not to Failure: Acute and Delayed Markers of Mechanical, Neuromuscular, and Biochemical Fatigue.","ABSTRACT González-Hernández, JM, García-Ramos, A, Colomer-Poveda, D, Tvarijonaviciute, A, Cerón, J, Jiménez-Reyes, P, and Márquez, G. Resistance training to failure vs. not to failure: acute and delayed markers of mechanical, neuromuscular, and biochemical fatigue. J Strength Cond Res 35(4): 886-893, 2021-This study aimed to compare acute and delayed markers of mechanical, neuromuscular, and biochemical fatigue between resistance training sessions leading to or not to failure. Twelve resistance-trained men completed 2 sessions that consisted of 6 sets of the full-squat exercise performed against the 10 repetitions maximum load. In a randomized order, in one session the sets were performed to failure and in the other session the sets were not performed to failure (5 repetitions per set). Mechanical fatigue was quantified through the recording of the mean velocity during all repetitions. The neuromuscular function of the knee extensors was assessed through a maximal voluntary contraction and the twitch interpolation technique before training, immediately after each set, and 1, 24, and 48 hours post-training. Serum creatine kinase (CK) and aspartate aminotransferase (AST) were measured before training and 1, 24, and 48 hours post-training to infer muscle damage. Alpha was set at a level of 0.05. A higher velocity loss between sets was observed during the failure protocol (-21.7%) compared with the nonfailure protocol (-3.5%). The markers of peripheral fatigue were generally higher and long lasting for the failure protocol. However, the central fatigue assessed by the voluntary activation was comparable for both protocols and remained depressed up to 48 hours post-training. The concentrations of CK and AST were higher after the failure protocol revealing higher muscle damage compared with the nonfailure protocol. These results support the nonfailure protocol to reduce peripheral fatigue and muscle damage, whereas the central fatigue does not seem to be affected by the set configuration.",2021,The concentrations of CK and AST were higher after the failure protocol revealing higher muscle damage compared with the nonfailure protocol.,"['Failure', 'Twelve resistance-trained men']","['full-squat exercise performed against the 10 repetitions maximum load', 'J Strength Cond Res XX(X']","['Mechanical fatigue', 'velocity loss', 'peripheral fatigue and muscle damage', 'peripheral fatigue', 'concentrations of CK and AST', 'Serum creatine kinase (CK) and aspartate aminotransferase (AST', 'central fatigue assessed by the voluntary activation', 'Acute and Delayed Markers of Mechanical, Neuromuscular, and Biochemical Fatigue']","[{'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0858112', 'cui_str': 'Serum creatine'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}]",,0.0326808,The concentrations of CK and AST were higher after the failure protocol revealing higher muscle damage compared with the nonfailure protocol.,"[{'ForeName': 'Jorge M', 'Initials': 'JM', 'LastName': 'González-Hernández', 'Affiliation': 'Faculty of Health Science, European University of Canarias, Tenerife, Spain.'}, {'ForeName': 'Amador', 'Initials': 'A', 'LastName': 'García-Ramos', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Colomer-Poveda', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, Catholic University of Murcia (UCAM), Murcia, Spain.'}, {'ForeName': 'Asta', 'Initials': 'A', 'LastName': 'Tvarijonaviciute', 'Affiliation': 'Department of Animal Medicine and Surgery, Faculty of Veterinary Medicine, Regional Campus of International Excellence ""Campus Mare Nostrum,"" University of Murcia, Murcia, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Cerón', 'Affiliation': 'Department of Animal Medicine and Surgery, Faculty of Veterinary Medicine, Regional Campus of International Excellence ""Campus Mare Nostrum,"" University of Murcia, Murcia, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Jiménez-Reyes', 'Affiliation': 'Center for Sport Studies, Rey Juan Carlos University, Madrid, Spain; and.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Márquez', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, Catholic University of Murcia (UCAM), Murcia, Spain.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003921'] 1636,33310502,REM density is associated with treatment response in major depression: Antidepressant pharmacotherapy vs. psychotherapy.,"Major depression is one of the most common psychiatric illnesses. Interestingly, a few studies have indicated the existence of depression subgroups, which respond differently to the available treatment options. Previously, sleep abnormalities have been suggested to indicate amenability to different treatment regimens. Thereby, especially REM-sleep parameters seem to play a prominent role, and REM-sleep dysregulation has been repeatedly discussed as a potential endophenotype of depression. With that said, estimating therapy outcome in order to choose the best line of treatment is of utmost importance to patients suffering from depression. The present study looks deeper into these clues by investigating the capability of polysomnographic sleep parameters to predict treatment response in depressed patients to either pharmacotherapy or psychotherapy. Moderately to severely depressed patients (n = 38) were randomly assigned to either psychotherapy (i.e. interpersonal psychotherapy) or pharmacotherapy (i.e., monotherapy with selective serotonin reuptake inhibitors, SSRI, or selective serotonin noradrenalin reuptake inhibitors, SSNRI). Prior to treatment, all patients underwent polysomnography in the sleep laboratory. After treatment, responders and non-responders of both treatment groups were compared regarding their baseline sleep parameters. Higher baseline REM density, i.e. the amount of rapid eye movements during REM sleep, predicted better response to antidepressant pharmacotherapy. In the psychotherapy group, the effect seemed reversed but was not statistically significant. No other sleep parameter predicted treatment response. Our findings support the notion that REM-sleep dysregulation is indeed indicative of a distinct endophenotype of depression and that pharmacotherapy with SSRI/SSNRI might be superior to psychotherapy in these patients.",2021,"In the psychotherapy group, the effect seemed reversed but was not statistically significant.","['patients suffering from depression', 'Moderately to severely depressed patients (n\xa0=\xa038', 'depressed patients to either']","['pharmacotherapy or psychotherapy', 'psychotherapy (i.e. interpersonal psychotherapy) or pharmacotherapy (i.e., monotherapy with selective serotonin reuptake inhibitors, SSRI, or selective serotonin noradrenalin reuptake inhibitors, SSNRI', 'pharmacotherapy vs. psychotherapy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]",[],38.0,0.013702,"In the psychotherapy group, the effect seemed reversed but was not statistically significant.","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Lechinger', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Schleswig-Holstein, Kiel.Niemannsweg 147, 24105, Kiel, Germany. Electronic address: julia.lechinger@uksh.de.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Koch', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Schleswig-Holstein, Kiel.Niemannsweg 147, 24105, Kiel, Germany.'}, {'ForeName': 'Sara Lena', 'Initials': 'SL', 'LastName': 'Weinhold', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Schleswig-Holstein, Kiel.Niemannsweg 147, 24105, Kiel, Germany.'}, {'ForeName': 'Mareen', 'Initials': 'M', 'LastName': 'Seeck-Hirschner', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Schleswig-Holstein, Kiel.Niemannsweg 147, 24105, Kiel, Germany.'}, {'ForeName': 'Karoline', 'Initials': 'K', 'LastName': 'Stingele', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Schleswig-Holstein, Kiel.Niemannsweg 147, 24105, Kiel, Germany.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Kropp-Näf', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Schleswig-Holstein, Kiel.Niemannsweg 147, 24105, Kiel, Germany.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Braun', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Schleswig-Holstein, Kiel.Niemannsweg 147, 24105, Kiel, Germany.'}, {'ForeName': 'Henning Johannes', 'Initials': 'HJ', 'LastName': 'Drews', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Schleswig-Holstein, Kiel.Niemannsweg 147, 24105, Kiel, Germany.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Aldenhoff', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Schleswig-Holstein, Kiel.Niemannsweg 147, 24105, Kiel, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Huchzermeier', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Schleswig-Holstein, Kiel.Niemannsweg 147, 24105, Kiel, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Göder', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Schleswig-Holstein, Kiel.Niemannsweg 147, 24105, Kiel, Germany. Electronic address: robert.goeder@uksh.de.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.12.009'] 1637,33310500,"Efficacy, safety and tolerability of formula-based unilateral vs bilateral electroconvulsive therapy in the treatment of major depression: A randomized open label controlled trial.","Electroconvulsive therapy (ECT) remains the most effective treatment of depression, though it is still unclear which of its type is the most beneficial. The aim of this study was to compare the formula-based right unilateral ECT (RUL) with the fronto-temporal bilateral ECT (BT), in terms of their efficacy, safety and tolerability in patients with bipolar or unipolar depression. Ninety-one patients were randomly assigned to either BT (n = 45) or RUL (n = 46) ECT. Brief pulse width (0.5 ms) and a formula-based dosing method were applied. The clinical efficacy was assessed using the Hamilton Depression Rating Scale (HDRS-21).The somatic state was monitored throughout the ECT course and cognitive examination included: general cognitive performance, executive functions, visual-spatial functions, verbal fluency, verbal memory and autobiographical memory. Efficacy outcomes were not found to be significantly different between groups when using higher doses of energy in RUL ECT. Patients in RUL group were less likely to be confused and experienced increased blood pressure. The indices of general cognitive performance and verbal auditory memory were also significantly better this group, while BT ECT did not change these functions. Both ECT types resulted in a decline in the retrieval consistency of autobiographical memory that persists for at least three months and was significantly more marked in BT group as compared to RUL. In conclusion, formula-based RUL ECT does not differ from BT in antidepressant efficacy and has an advantage in terms of safety (lower incidence of increased blood pressure and fewer disturbances of consciousness) and tolerability (impact on cognitive functions).",2021,"The indices of general cognitive performance and verbal auditory memory were also significantly better this group, while BT ECT did not change these functions.","['Ninety-one patients', 'patients with bipolar or unipolar depression', 'major depression']","['formula-based unilateral vs bilateral electroconvulsive therapy', 'formula-based RUL ECT', 'RUL (n\xa0=\xa046) ECT', 'BT ECT', 'formula-based right unilateral ECT (RUL) with the fronto-temporal bilateral ECT (BT', 'BT', 'Electroconvulsive therapy (ECT']","['general cognitive performance, executive functions, visual-spatial functions, verbal fluency, verbal memory and autobiographical memory', 'Hamilton Depression Rating Scale (HDRS-21).The somatic state', 'blood pressure and fewer disturbances of consciousness) and tolerability (impact on cognitive functions', 'Efficacy, safety and tolerability', 'retrieval consistency of autobiographical memory', 'general cognitive performance and verbal auditory memory', 'efficacy, safety and tolerability', 'Efficacy outcomes', 'blood pressure']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0562343', 'cui_str': 'Bilateral electroconvulsive therapy'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0562344', 'cui_str': 'Unilateral electroconvulsive therapy'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C1840333', 'cui_str': 'Hypoparathyroidism, deafness, renal disease syndrome'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0234428', 'cui_str': 'Disturbance of consciousness'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0561779', 'cui_str': 'Auditory memory'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",91.0,0.0357442,"The indices of general cognitive performance and verbal auditory memory were also significantly better this group, while BT ECT did not change these functions.","[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Dominiak', 'Affiliation': 'Department of Pharmacology, Institute of Psychiatry and Neurology, Sobieskiego 9, 02-957, Warsaw, Poland. Electronic address: mdominia@wp.pl.'}, {'ForeName': 'Anna Z', 'Initials': 'AZ', 'LastName': 'Antosik-Wójcińska', 'Affiliation': 'Department of Psychiatry, Medical University of Warsaw, Nowowiejska 27, 00-665, Warsaw, Poland.'}, {'ForeName': 'Zuzanna', 'Initials': 'Z', 'LastName': 'Goetz', 'Affiliation': 'Institute of Psychiatry and Neurology, Sobieskiego 9, 02-957, Warsaw, Poland.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Sikorska', 'Affiliation': 'Institute of Psychiatry and Neurology, Sobieskiego 9, 02-957, Warsaw, Poland.'}, {'ForeName': 'Bogdan', 'Initials': 'B', 'LastName': 'Stefanowski', 'Affiliation': 'Institute of Psychiatry and Neurology, Sobieskiego 9, 02-957, Warsaw, Poland.'}, {'ForeName': 'Dagny', 'Initials': 'D', 'LastName': 'Gorostiza', 'Affiliation': 'Institute of Psychiatry and Neurology, Sobieskiego 9, 02-957, Warsaw, Poland.'}, {'ForeName': 'Łukasz', 'Initials': 'Ł', 'LastName': 'Święcicki', 'Affiliation': 'Department of Affective Disorders, Institute of Psychiatry and Neurology, Sobieskiego 9, 02-957, Warsaw, Poland.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.12.002'] 1638,33309237,The development of a social norms adherence intervention for adolescents with epilepsy.,"INTRODUCTION Adherence is suboptimal in adolescents with epilepsy. Social norms comparison (i.e., feedback about someone else's behavior related to one's own behavior) strategies may be beneficial in improving medication adherence. Using a novel model of behavioral intervention development, the aim of the current study was to create a social norms intervention for adolescents with epilepsy via focus groups and usability studies. METHODS A focus group, individual interviews, short-term usability, and extended usage testing studies were conducted. Across all study phases, content and images of intervention components were displayed to participants as mock-ups in PowerPoint slide decks. After each phase, updated iterations were shown to participants to refine the intervention. Several questionnaires were completed by adolescents and caregivers to characterize the samples. RESULTS Twelve adolescents participated in the focus group/individual interviews and usability studies. The final Behavioral Economic Adherence for Teens (BEAT) intervention consists of a text messaging system and a graphical user interface. General feedback indicated the need for simplicity and ease of use regarding obtaining the graphical messages (e.g., no extra login and passwords); engaging visual images; and weekly comparisons of a target patient's medication adherence to other adolescents' performance. The average system usability system (SUS) rating was 88.3 + 3.8. CONCLUSIONS Our final intervention had high usability ratings and was perceived as engaging and easy to understand. An important next step is to test the BEAT intervention in a Phase 2 randomized trial.",2021,The final Behavioral Economic Adherence for Teens (BEAT) intervention consists of a text messaging system and a graphical user interface.,"['adolescents with epilepsy', 'Twelve adolescents participated in the focus group/individual interviews and usability studies', 'adolescents with epilepsy via focus groups and usability studies']","['BEAT intervention', 'social norms adherence intervention']","['usability ratings', 'average system usability system (SUS) rating', 'final Behavioral Economic Adherence']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",12.0,0.0328397,The final Behavioral Economic Adherence for Teens (BEAT) intervention consists of a text messaging system and a graphical user interface.,"[{'ForeName': 'Avani C', 'Initials': 'AC', 'LastName': 'Modi', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave., Cincinnati, OH 45229-3039, USA; University of Cincinnati, College of Medicine, USA. Electronic address: avani.modi@cchmc.org.""}, {'ForeName': 'Anup D', 'Initials': 'AD', 'LastName': 'Patel', 'Affiliation': ""Nationwide Children's Hospital, 700 Children's Drive, Near East Office Building, 3rd Floor, Columbus, OH 43205, USA; The Ohio State, Department of Pediatrics, 700 Children's Drive, Near East Office Building, 3rd Floor, Columbus, OH 43205, USA.""}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Gutierrez-Colina', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave., Cincinnati, OH 45229-3039, USA.""}, {'ForeName': 'Sara E', 'Initials': 'SE', 'LastName': 'Wetter', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave., Cincinnati, OH 45229-3039, USA.""}, {'ForeName': 'Leah M', 'Initials': 'LM', 'LastName': 'Heckaman', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave., Cincinnati, OH 45229-3039, USA.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Debs', 'Affiliation': ""Nationwide Children's Hospital, 700 Children's Drive, Near East Office Building, 3rd Floor, Columbus, OH 43205, USA.""}, {'ForeName': 'Constance A', 'Initials': 'CA', 'LastName': 'Mara', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave., Cincinnati, OH 45229-3039, USA; University of Cincinnati, College of Medicine, USA.""}, {'ForeName': 'Evelynne', 'Initials': 'E', 'LastName': 'Wentzel', 'Affiliation': ""Nationwide Children's Hospital, 700 Children's Drive, Near East Office Building, 3rd Floor, Columbus, OH 43205, USA.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Schmidt', 'Affiliation': 'College of Education, University of Florida, 2423 Normal Hall, Gainesville, FL 32611, USA.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Stevens', 'Affiliation': ""Nationwide Children's Hospital, 700 Children's Drive, Near East Office Building, 3rd Floor, Columbus, OH 43205, USA; The Ohio State, Department of Pediatrics, 700 Children's Drive, Near East Office Building, 3rd Floor, Columbus, OH 43205, USA.""}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107628'] 1639,33789481,Vascular impulse technology versus elevation for the reduction of swelling of lower extremity joint fractures: results of a prospective randomized controlled study.,"AIMS Complex joint fractures of the lower extremity are often accompanied by soft-tissue swelling and are associated with prolonged hospitalization and soft-tissue complications. The aim of the study was to evaluate the effect of vascular impulse technology (VIT) on soft-tissue conditioning in comparison with conventional elevation. METHODS A total of 100 patients were included in this prospective, randomized, controlled monocentre study allocated to the three subgroups of dislocated ankle fracture (n = 40), pilon fracture (n = 20), and intra-articular calcaneal fracture (n = 40). Patients were randomized to the two study groups in a 1:1 ratio. The effectiveness of VIT (intervention) compared with elevation (control) was analyzed separately for the whole study population and for the three subgroups. The primary endpoint was the time from admission until operability (in days). RESULTS The mean length of time until operability was 8.2 days (SD 3.0) in the intervention group and 10.2 days (SD 3.7) in the control group across all three fractures groups combined (p = 0.004). An analysis of the subgroups revealed that a significant reduction in the time to operability was achieved in two of the three: with 8.6 days (SD 2.2) versus 10.6 days (SD 3.6) in ankle fractures (p = 0.043), 9.8 days (SD 4.1) versus 12.5 days (SD 5.1) in pilon fractures (p = 0.205), and 7.0 days (SD 2.6) versus 8.4 days (SD 1.5) in calcaneal fractures (p = 0.043). A lower length of stay (p = 0.007), a reduction in pain (p preop = 0.05; p discharge < 0.001) and need for narcotics (p preop = 0.064; p postop = 0.072), an increased reduction in swelling (p < 0.001), and a lower revision rate (p = 0.044) could also be seen, and a trend towards fewer complications (p = 0.216) became apparent. CONCLUSION Compared with elevation, VIT results in a significant reduction in the time to achieve operability in complex joint fractures of the lower limb. Cite this article: Bone Joint J  2021;103-B(4):746-754.",2021,"A lower length of stay (p = 0.007), a reduction in pain (p preop = 0.05; p discharge < 0.001) and need for narcotics (p preop = 0.064; p postop = 0.072), an increased reduction in swelling (p < 0.001), and a lower revision rate (p = 0.044) could also be seen, and a trend towards fewer complications (p = 0.216) became apparent. ","['A total of 100 patients', 'n = 40), pilon fracture (n = 20), and intra-articular calcaneal fracture (n = 40', 'swelling of lower extremity joint fractures']","['Vascular impulse technology versus elevation', 'vascular impulse technology (VIT', 'dislocated ankle fracture', 'VIT (intervention']","['reduction in swelling', 'lower revision rate', 'time to operability', 'reduction in pain', 'mean length of time until operability', 'ankle fractures', 'length of stay', 'time from admission until operability (in days']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0435895', 'cui_str': 'Pilon fracture'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0006655', 'cui_str': 'Bone structure of calcaneum'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0581394', 'cui_str': 'Swelling of lower limb'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0434691', 'cui_str': 'Traumatic dislocation of ankle joint'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0159877', 'cui_str': 'Fracture of ankle'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",100.0,0.0344077,"A lower length of stay (p = 0.007), a reduction in pain (p preop = 0.05; p discharge < 0.001) and need for narcotics (p preop = 0.064; p postop = 0.072), an increased reduction in swelling (p < 0.001), and a lower revision rate (p = 0.044) could also be seen, and a trend towards fewer complications (p = 0.216) became apparent. ","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Schnetzke', 'Affiliation': 'German Joint Centre Heidelberg, ATOS Clinic Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'El Barbari', 'Affiliation': 'Department for Traumatology and Orthopaedics, BG Trauma Centre Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': 'Svenja', 'Initials': 'S', 'LastName': 'Schüler', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Benedict', 'Initials': 'B', 'LastName': 'Swartman', 'Affiliation': 'Department for Traumatology and Orthopaedics, BG Trauma Centre Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Keil', 'Affiliation': 'Department for Traumatology and Orthopaedics, BG Trauma Centre Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Vetter', 'Affiliation': 'Department for Traumatology and Orthopaedics, BG Trauma Centre Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': 'Paul Alfred', 'Initials': 'PA', 'LastName': 'Gruetzner', 'Affiliation': 'Department for Traumatology and Orthopaedics, BG Trauma Centre Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Franke', 'Affiliation': 'Department for Traumatology and Orthopaedics, BG Trauma Centre Ludwigshafen, Ludwigshafen, Germany.'}]",The bone & joint journal,['10.1302/0301-620X.103B4.BJJ-2020-1260.R1'] 1640,33789474,A feasibility study of standard dressings versus negative-pressure wound therapy in the treatment of adult patients having surgical incisions for hip fractures: the WHISH randomized controlled trial.,"AIMS This study sought to compare the rate of deep surgical site infection (SSI), as measured by the Centers for Disease Control and Prevention (CDC) definition, after surgery for a fracture of the hip between patients treated with standard dressings and those treated with incisional negative pressure wound therapy (iNPWT). Secondary objectives included determining the rate of recruitment and willingness to participate in the trial. METHODS The study was a two-arm multicentre randomized controlled feasibility trial that was embedded in the World Hip Trauma Evaluation cohort study. Any patient aged > 65 years having surgery for hip fracture at five recruitment centres in the UK was considered to be eligible. They were randomly allocated to have either a standard dressing or iNPWT after closure of the wound. The primary outcome measure was deep SSI at 30 and 90 days, diagnosed according to the CDC criteria. Secondary outcomes were: rate of recruitment; further surgery within 120 days; health-related quality of life (HRQoL) using the EuroQol five-level five-dimension questionnaire (EQ-5D-5L); and related complications within 120 days as well as mobility and residential status at this time. RESULTS A total of 462 valid randomizations were carried out (232 and 230 in the standard dressing and iNPWT groups, respectively). In the standard dressing group, 14 of 218 patients (6.4%) developed deep SSI. In the iNPWT group, four of 214 patients (1.9%) developed deep SSI. This gives a total rate of SSI of 4.2% (95% confidence interval (CI) 2.7% to 6.5%). Patients and surgeons were willing to participate in the study with 462 patients being recruited from a possible 749 (62.3%). CONCLUSION The rate of deep SSI 30 days after surgery for a fracture of the hip was 4%, which makes a study comparing the clinical effectiveness of standard dressings and iNPWT feasible. Cite this article: Bone Joint J  2021;103-B(4):755-761.",2021,"A total of 462 valid randomizations were carried out (232 and 230 in the standard dressing and iNPWT groups, respectively).","['Any patient aged > 65 years having surgery for hip fracture at five recruitment centres in the UK was considered to be eligible', 'Patients and surgeons were willing to participate in the study with 462 patients being recruited from a possible 749 (62.3', 'adult patients having surgical incisions for hip fractures']","['standard dressing or iNPWT', 'standard dressings versus negative-pressure wound therapy', 'standard dressings and those treated with incisional negative pressure wound therapy (iNPWT']","['total rate of SSI', 'rate of recruitment and willingness to participate in the trial', 'deep SSI', 'rate of deep surgical site infection (SSI', 'rate of recruitment; further surgery within 120 days; health-related quality of life (HRQoL) using the EuroQol five-level five-dimension questionnaire (EQ-5D-5L); and related complications within 120 days as well as mobility and residential status at this time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0184898', 'cui_str': 'Incision'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0971923,"A total of 462 valid randomizations were carried out (232 and 230 in the standard dressing and iNPWT groups, respectively).","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Masters', 'Affiliation': 'Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Cook', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Sciences, Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Juul', 'Initials': 'J', 'LastName': 'Achten', 'Affiliation': 'Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Matt L', 'Initials': 'ML', 'LastName': 'Costa', 'Affiliation': 'Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}]",The bone & joint journal,['10.1302/0301-620X.103B4.BJJ-2020-1603.R1'] 1641,33789470,The influence of expectation modification in knee arthroplasty on satisfaction of patients: a randomized controlled trial.,"AIMS Meeting preoperative expectations is known to be of major influence on postoperative satisfaction after total knee arthroplasty (TKA). Improved management of expectation, resulting in more realistic expectations can potentially lead to higher postoperative satisfaction. The objective of this study was to assess the effect of an additional preoperative education module, addressing realistic expectations for long-term functional recovery, on postoperative satisfaction and expectation fulfilment. METHODS In total, 204 primary TKA patients with osteoarthritis were enrolled in this randomized controlled trial (RCT). Patients were allocated to either usual preoperative education (control group) or usual education plus an additional module on realistic expectations (intervention group). Primary outcome was being very satisfied (numerical rating scale for satisfaction ≥ 8) with the treatment result at 12 months' follow-up. Other outcomes were change in preoperative expectations and postoperative expectation fulfilment. RESULTS A total of 187 patients (91.7%) were available for analysis at follow-up. In the intention-to-treat analysis, 58.5% (55/94) of patients were very satisfied with the treatment result in the control group, and 69.9% (65/93) of patients in the intervention group (adjusted odds ratio (AOR) 1.72, 95% confidence interval (CI) 0.90 to 3.29). A per-protocol analysis for patients who attended the education session (92.0%, n = 172) showed that 56.9% (49/86) of patients were very satisfied in the control group and 74.4% (61/86) in the intervention group (AOR 2.44, 95% CI 1.21 to 4.91). After preoperative education, the expectation scores in the intervention group were significantly lower (mean difference -6.9 (95% CI -10.2 to -3.6)) and did not alter in the control group (mean difference 0.5 (95% CI -2.9 to 3.9)). Overall, fulfilment of expectations at 12 months was significantly higher in the intervention group (mean difference 11.4% (95% CI 2.3 to 20.5)). CONCLUSION Improved preoperative patient education can modify patient expectations, resulting in higher postoperative fulfilment of expectation and higher satisfaction in the group that attended the preoperative education. This is the first RCT to confirm the potential of improved expectation management on satisfaction after TKA. Cite this article: Bone Joint J  2021;103-B(4):619-626.",2021,"Overall, fulfilment of expectations at 12 months was significantly higher in the intervention group (mean difference 11.4% (95% CI 2.3 to 20.5)). ","['knee arthroplasty on satisfaction of patients', '204 primary TKA patients with osteoarthritis', 'A total of 187 patients (91.7%) were available for analysis at follow-up', 'total knee arthroplasty (TKA']",['usual preoperative education (control group) or usual education plus an additional module on realistic expectations (intervention group'],"['Overall, fulfilment of expectations', 'expectation scores', 'preoperative expectations and postoperative expectation fulfilment', 'very satisfied (numerical rating scale for satisfaction ≥ 8']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0204956', 'cui_str': 'Preoperative education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",204.0,0.279302,"Overall, fulfilment of expectations at 12 months was significantly higher in the intervention group (mean difference 11.4% (95% CI 2.3 to 20.5)). ","[{'ForeName': 'Jaap J', 'Initials': 'JJ', 'LastName': 'Tolk', 'Affiliation': 'Department of Orthopaedic Surgery and Trauma, Máxima MC, Eindhoven, The Netherlands.'}, {'ForeName': 'Rob P A', 'Initials': 'RPA', 'LastName': 'Janssen', 'Affiliation': 'Department of Orthopaedic Surgery and Trauma, Máxima MC, Eindhoven, The Netherlands.'}, {'ForeName': 'Tsjitske M', 'Initials': 'TM', 'LastName': 'Haanstra', 'Affiliation': 'Department of Orthopaedic Surgery, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'van der Steen', 'Affiliation': 'Department of Orthopaedic Surgery and Trauma, Máxima MC, Eindhoven, The Netherlands.'}, {'ForeName': 'Sita M A', 'Initials': 'SMA', 'LastName': 'Bierma-Zeinstra', 'Affiliation': 'Department of General Practice, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Reijman', 'Affiliation': 'Department of Orthopaedic Surgery, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, The Netherlands.'}]",The bone & joint journal,['10.1302/0301-620X.103B4.BJJ-2020-0629.R3'] 1642,33281095,Acute psycho-physiological responses to perceptually regulated hypoxic and normoxic interval walks in overweight-to-obese adults.,"OBJECTIVES We investigated psycho-physiological responses to perceptually regulated interval walks in hypoxia versus normoxia in obese individuals. DESIGN Within-participants repeated measures. METHODS Ten obese adults (BMI=32±3kg/m -2 ) completed a 60-min interval session (15×2min walking at a rating of perceived exertion of 14 on the 6-20 Borg scale with 2min of rest) either in hypoxia (FiO 2 =13.0%, HYP) or normoxia (NOR). A third trial replicating the HYP speed pattern was carried out in normoxia as a control (CON). Exercise responses were analysed comparing the average of 1st to 3rd exercise bouts to those of the 4th-6th, 7th-9th, 10th-12th and 13th-15th exercise bouts (block 1 versus 2, 3, 4 and 5). RESULTS Treadmill speed was slower during block 4 (6.14±0.67 versus 6.24±0.73km/h -1 ) and block 5 (6.12±0.64 versus 6.25±0.75km/h -1 ) in HYP compared to NOR or CON (p=0.009). Compared to NOR and CON, heart rate was +6-10% higher (p=0.001), whilst arterial oxygen saturation (-12-13%) was lower (p<0.001) in HYP. Perceived limb discomfort was lower in HYP and CON versus NOR (-21±4% and -34±6%; p=0.004). CONCLUSIONS In overweight-to-obese adults, perceptually regulated interval walks in hypoxia versus normoxia leads to progressively slower speeds along with lower limb discomfort and larger physiological stress than normoxia. Walking at the speed adopted in hypoxia produces similar psycho-physiological responses at the same absolute intensity in normoxia.",2021,"Compared to NOR and CON, heart rate was +6-10% higher (p=0.001), whilst arterial oxygen saturation (-12-13%) was lower (p<0.001) in HYP.","['overweight-to-obese adults', 'obese individuals', 'Ten obese adults (BMI=32±3kg/m -2 ) completed a']","['60-min interval session (15×2min walking at a rating of perceived exertion of 14 on the 6-20 Borg scale with 2min of rest) either in hypoxia (FiO 2 =13.0%, HYP) or normoxia (NOR', 'perceptually regulated hypoxic and normoxic interval walks']","['Exercise responses', 'arterial oxygen saturation', 'NOR and CON, heart rate', 'Treadmill speed', 'Perceived limb discomfort']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0449399', 'cui_str': 'Borg scale'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0733682', 'cui_str': 'Hypophosphatemic Rickets, X-Linked Dominant'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0854303', 'cui_str': 'Limb discomfort'}]",10.0,0.0357045,"Compared to NOR and CON, heart rate was +6-10% higher (p=0.001), whilst arterial oxygen saturation (-12-13%) was lower (p<0.001) in HYP.","[{'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Hobbins', 'Affiliation': 'Sport and Exercise Science Research Centre (SESRC), London South Bank University, United Kingdom.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Girard', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Australia. Electronic address: olivier.girard@uwa.edu.au.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Gaoua', 'Affiliation': 'Sport and Exercise Science Research Centre (SESRC), London South Bank University, United Kingdom.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Hunter', 'Affiliation': 'Sport and Exercise Science Research Centre (SESRC), London South Bank University, United Kingdom.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.11.011'] 1643,33283487,Crestal bone stability after flapless placement of sloped implants with immediate temporization in edentulous mandible. A prospective comparative clinical trial.,"OBJECTIVES The purpose of this study was to evaluate crestal bone stability around sloped implants using the flapless procedure and compare it with conventional implants placed axially. MATERIALS AND METHODS A total of 40 bone-level implants with platform switching were used for this study for 10 patients (4 males and 6 females) in edentulous mandible. Twenty mesial conventional implants were placed in upright position and 20 distal 30° sloped implants tilted 30°. Bone loss was estimated using radiographic imaging after a 6- and a 12-month follow-up period. Comparison of the bone loss in the distal and mesial region at both implantation angles were conducted to understand the nature and progression of crestal bone loss. RESULTS Crestal bone loss around the sloped implants was 0.29 mm (SD = 0.292) on average, while around conventional implants it was 0.22 mm (SD = 0.202) after one-year follow-up. However, there was no significant difference in the average of crestal bone loss between two trial groups after 6 months (p < 0.243) and one-year (p < 0.614) follow-up. The results indicated a 100% implant survival rate after one-year follow-up. Additionally, three fixed prostheses needed realignment after fracturing during the follow-up time. CONCLUSION Considering the limitations of this study, it can be presumed that sloped and conventional implants with platform switching and conical connection have the same potential for minimal crestal bone loss.",2021,"RESULTS Crestal bone loss around the sloped implants was 0.29 mm (SD = 0.292) on average, while around conventional implants it was 0.22 mm (SD = 0.202) after one-year follow-up.","['Twenty mesial conventional implants were placed in upright position and 20 distal 30', 'edentulous mandible', '10 patients (4 males and 6 females) in edentulous mandible']",['40 bone-level implants with platform switching'],"['Bone loss', 'Crestal bone loss', 'Crestal bone stability', 'average of crestal bone loss', 'crestal bone stability', 'implant survival rate']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C3853359', 'cui_str': 'Edentulous mandible'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.0399174,"RESULTS Crestal bone loss around the sloped implants was 0.29 mm (SD = 0.292) on average, while around conventional implants it was 0.22 mm (SD = 0.202) after one-year follow-up.","[{'ForeName': 'Algirdas', 'Initials': 'A', 'LastName': 'Puisys', 'Affiliation': 'Vilnius Research Group, Private Practice VIC Clinic, Vilnius, Lithuania.'}, {'ForeName': 'Viktorija', 'Initials': 'V', 'LastName': 'Auzbikaviciute', 'Affiliation': 'VIC Clinic, Vilnius, Lithuania.'}, {'ForeName': 'Egle', 'Initials': 'E', 'LastName': 'Vindasiute-Narbute', 'Affiliation': 'Institute of Odontology, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Saulius', 'Initials': 'S', 'LastName': 'Zukauskas', 'Affiliation': 'Institute of Odontology, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Kestutis', 'Initials': 'K', 'LastName': 'Vaicekauskas', 'Affiliation': 'VIC Clinic, Vilnius, Lithuania.'}, {'ForeName': 'Dainius', 'Initials': 'D', 'LastName': 'Razukevicus', 'Affiliation': 'Lithuania University of Health Science, Kaunas, Lithuania.'}]",Clinical and experimental dental research,['10.1002/cre2.352'] 1644,33280826,Response to letter to the editor-Clinical behavior of posterior fixed partial dentures with a biologically oriented preparation technique: A 5-year randomized controlled clinical trial.,,2021,,[],['posterior fixed partial dentures with a biologically oriented preparation technique'],[],[],"[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0011461', 'cui_str': 'Fixed Partial Denture'}, {'cui': 'C0205460', 'cui_str': 'Biologic'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",[],,0.108891,,"[{'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Serra-Pastor', 'Affiliation': 'Associate Professor, Department of Stomatology, Faculty of Medicine and Dentistry, Valencia University, Valencia, Spain.'}, {'ForeName': 'Rubén', 'Initials': 'R', 'LastName': 'Agustin-Panadero', 'Affiliation': 'Adjunct Professor, Department of Stomatology, Faculty of Medicine and Dentistry, Valencia University, Valencia, Spain.'}, {'ForeName': 'M Fernanda', 'Initials': 'MF', 'LastName': 'Solá-Ruiz', 'Affiliation': 'Adjunct Professor, Department of Stomatology, Faculty of Medicine and Dentistry, Valencia University, Valencia, Spain.'}]",The Journal of prosthetic dentistry,['10.1016/j.prosdent.2020.11.001'] 1645,33279855,Androgen deprivation therapy and radiotherapy in intermediate-risk prostate cancer: A randomised phase III trial.,"BACKGROUND The role of androgen deprivation therapy (ADT) in combination with radiotherapy (RT) in intermediate-risk prostate cancer (IRPC) remains controversial, particularly in patients receiving dose-escalated RT (DERT). We compared outcomes between patients with IRPC treated with ADT and two different doses of RT vs. RT alone. METHODS From December 2000 to September 2010, 600 patients with IRPC were randomised to a three-arm trial consisting of 6 months of ADT plus RT 70 Gy (ADT + RT70) vs. ADT plus a DERT of 76 Gy (ADT + DERT76) vs. DERT of 76 Gy alone (DERT76). Primary end-point was biochemical failure (BF), and secondary end-points were overall survival (OS) and toxicity. RT toxicity was assessed by Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer criteria. FINDINGS With a median follow-up of 11.3 years (interquartile range: 10.9-11.7), patients receiving DERT76 alone, compared with patients receiving ADT + RT70 and ADT + DERT76, had higher rates of BF (32%, 18% and 14%, respectively, p < 0.001), higher rates of prostate cancer progression (12%, 4.5% and 3.3%, respectively, p = 0.001) and more deaths due to prostate cancer (6.5%, 3.0% and 1.5%, respectively, p = 0.03) with no significant difference seen between ADT + RT70 and ADT + DERT76. There was no significant difference in OS between the 3 arms. A higher dose of RT (76 Gy) increased late gastrointestinal (GI) toxicity grade ≥ II compared with lower dose (70 Gy) (16% vs 5.3%, p < 0.001) with no statistical difference for late genitourinary toxicity. INTERPRETATION In IRPC, the addition of 6 months of ADT to RT70 or DERT76 significantly improves BF and appears to decrease the risk of death from prostate cancer compared with DERT76 alone with no difference in OS. In the setting of IRPC, ADT plus RT 70 Gy yields effective disease control with a better GI toxicity profile. Clinicaltrials.gov#NCT00223145.",2021,There was no significant difference in OS between the 3 arms.,"['600 patients with IRPC', 'intermediate-risk prostate cancer (IRPC', 'From December 2000 to September 2010', 'With a median follow-up of 11.3 years', 'patients with IRPC treated with', 'patients receiving dose-escalated RT (DERT', 'intermediate-risk prostate cancer']","['radiotherapy (RT', 'androgen deprivation therapy (ADT', 'Androgen deprivation therapy and radiotherapy', 'ADT plus RT 70\xa0Gy (ADT\xa0+\xa0RT70) vs. ADT plus a DERT of 76\xa0Gy (ADT\xa0+\xa0DERT76) vs. DERT of 76\xa0Gy alone (DERT76', 'RT vs. RT', 'ADT']","['higher rates of prostate cancer progression', 'biochemical failure (BF), and secondary end-points were overall survival (OS) and toxicity', 'OS', 'deaths due to prostate cancer', 'rates of BF', 'RT toxicity', 'late gastrointestinal (GI) toxicity grade\xa0≥\xa0II', 'late genitourinary toxicity', 'risk of death from prostate cancer']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",600.0,0.14783,There was no significant difference in OS between the 3 arms.,"[{'ForeName': 'Abdenour', 'Initials': 'A', 'LastName': 'Nabid', 'Affiliation': 'Centre Hospitalier Universitaire de Sherbrooke, CA, Canada. Electronic address: abdenour.nabid@usherbrooke.ca.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Carrier', 'Affiliation': 'Centre Hospitalier Universitaire de Sherbrooke, CA, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vigneault', 'Affiliation': 'Centre Hospitalier Universitaire de Québec, CA, Canada.'}, {'ForeName': 'Thu', 'Initials': 'T', 'LastName': 'Van Nguyen', 'Affiliation': 'Centre Hospitalier Universitaire de Montréal, CA, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vavassis', 'Affiliation': 'Hôpital Maisonneuve-Rosemont de Montréal, CA, Canada.'}, {'ForeName': 'Marc-André', 'Initials': 'MA', 'LastName': 'Brassard', 'Affiliation': 'Centre Intégré Universitaire de Santé et de Services Sociaux Du Saguenay-Lac-Saint-Jean, CA, Canada.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Bahoric', 'Affiliation': 'Hôpital Général Juif de Montréal, CA, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Archambault', 'Affiliation': 'Hôpital de Gatineau, CA, Canada.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Vincent', 'Affiliation': 'Centre Hospitalier Régional de Trois-Rivières, CA, Canada.'}, {'ForeName': 'Redouane', 'Initials': 'R', 'LastName': 'Bettahar', 'Affiliation': 'Centre Hospitalier Régional de Rimouski, CA, Canada.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Wilke', 'Affiliation': 'Nova Scotia Cancer Center, NS, Canada.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Souhami', 'Affiliation': 'McGill University Health Centre, CA, Canada.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.10.023'] 1646,33279854,"Triplet combination of durvalumab, tremelimumab, and paclitaxel in biliary tract carcinomas: Safety run-in results of the randomized IMMUNOBIL PRODIGE 57 phase II trial.","BACKGROUND The IMMUNOBIL PRODIGE 57 trial is a non-comparative randomized phase II study assessing the efficacy and safety of the durvalumab (an anti-PD-L1) and tremelimumab (an anti-CTLA4) combination with or without weekly paclitaxel in patients with advanced biliary tract carcinoma (BTC) after failure of platinum-based chemotherapy. Taxanes have already been safely combined with immune checkpoint inhibitors in other tumors. We report results of the 20-patient safety run-in. METHODS Patients received durvalumab (1500 mg at day 1 [D1] of each cycle)/tremelimumab (75 mg at D1 for 4 cycles; Arm A) or durvalumab/tremelimumab with paclitaxel (80 mg/m 2 at D1, D8, D15; Arm B) every 28 days. RESULTS Twenty patients were enrolled (Arm A/B: 10/10). There were no dose-limiting toxicities (DLTs) in Arm A. Six DLTs were observed in five patients (50%) in Arm B, meeting a stopping rule for the trial inclusions. DLTs included three serious anaphylactic reactions (with one cardiac arrest), two enterocolitis, and one infectious pneumopathy with septic shock. There were no patients with history of personal or familial auto-immune disease. CONCLUSION The safety run-in part of IMMUNOBIL PRODIGE 57 raised concerns regarding co-administration of paclitaxel with durvalumab and tremelimumab in BTC, with an unexpected increase in anaphylactic adverse events. Phase II of the study will only evaluate the durvalumab and tremelimumab combination arm. CLINICALTRIALS REGISTRATION NCT03704480.",2021,"There were no dose-limiting toxicities (DLTs) in Arm A. Six DLTs were observed in five patients (50%) in Arm B, meeting a stopping rule for the trial inclusions.","['biliary tract carcinomas', 'Twenty patients were enrolled (Arm A/B: 10/10', 'patients with advanced biliary tract carcinoma (BTC) after failure of platinum-based chemotherapy']","['cycle)/tremelimumab', 'durvalumab, tremelimumab, and paclitaxel', 'durvalumab', 'durvalumab/tremelimumab with paclitaxel', 'durvalumab (an anti-PD-L1) and tremelimumab (an anti-CTLA4) combination with or without weekly paclitaxel', 'Taxanes']","['dose-limiting toxicities (DLTs', 'serious anaphylactic reactions', 'anaphylactic adverse events', 'efficacy and safety', 'history of personal or familial auto-immune disease']","[{'cui': 'C0005423', 'cui_str': 'Biliary tract structure'}, {'cui': 'C0007097', 'cui_str': 'Carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C2351038', 'cui_str': 'tremelimumab'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C2350360', 'cui_str': 'CTLA4 protein, human'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0215136', 'cui_str': 'taxane'}]","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0002792', 'cui_str': 'Anaphylaxis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0021053', 'cui_str': 'Disorder of immune system'}]",20.0,0.0512191,"There were no dose-limiting toxicities (DLTs) in Arm A. Six DLTs were observed in five patients (50%) in Arm B, meeting a stopping rule for the trial inclusions.","[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Boilève', 'Affiliation': 'Department of Medical Oncology, Gustave Roussy Cancer Campus, Villejuif, France; GERCOR, Paris, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Hilmi', 'Affiliation': 'GERCOR, Paris, France; Department of Medical Oncology, Institut Curie - Site Saint Cloud, Versailles Saint-Quentin University, Paris Saclay University, Saint-Cloud, France.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gougis', 'Affiliation': 'Department of Pharmacology Sorbonne Université, INSERM, CIC-1901 Paris-Est, CLIP(2) Galilée, Assistance Publique - Hôpitaux de Paris, Pitié-Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Cohen', 'Affiliation': 'GERCOR, Paris, France; Department of Medical Oncology, Sorbonne Université, Assistance-Publique - Hôpitaux de Paris, Saint-Antoine Hospital, Paris, France.'}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Rousseau', 'Affiliation': 'GERCOR, Paris, France; Department of Medicine, Solid Tumor Division, Mortimer B. Zuckerman Research Center, Memorial Sloan Kettering Cancer Center, New York, USA.'}, {'ForeName': 'Jean-Frédéric', 'Initials': 'JF', 'LastName': 'Blanc', 'Affiliation': 'Department of Hepato-Gastro-Enterology and Digestive Oncology, Hôpital Haut-Lévêque, CHU de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Meher', 'Initials': 'M', 'LastName': 'Ben Abdelghani', 'Affiliation': 'Department of Medical Oncology, Centre Paul Strauss, Strasbourg, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Castanié', 'Affiliation': ""Institut de Cancérologie Catherine de Sienne, L'Hôpital Privé Du Confluent, Nantes, France.""}, {'ForeName': 'Laëtitia', 'Initials': 'L', 'LastName': 'Dahan', 'Affiliation': 'Department of Digestive Oncology, Centre Hospitalo-Universitaire La Timone, Marseille, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tougeron', 'Affiliation': 'Department of Hepato-Gastro-Enterology, Centre Hospitalo-Universitaire de Poitiers, Poitiers, France.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Metges', 'Affiliation': ""Centre Hospitalo-Universitaire Brest-Institut de Cancerologie et D'Hematologie, Brest, France.""}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Tournigand', 'Affiliation': 'Department of Medical Oncology, Assistance Publique-Hôpitaux de Paris, Hôpital Henri-Mondor, University Paris Est Créteil, Créteil, France.'}, {'ForeName': 'Marie-Line', 'Initials': 'ML', 'LastName': 'Garcia-Larnicol', 'Affiliation': 'GERCOR, Paris, France.'}, {'ForeName': 'Dewi', 'Initials': 'D', 'LastName': 'Vernerey', 'Affiliation': 'GERCOR, Paris, France; Unité de Méthodologie et de Qualité de Vie en Cancérologie (INSERM UMR 1098), CHU Besançon, Besançon, France.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Turpin', 'Affiliation': 'GERCOR, Paris, France; Department of Medical Oncology, Centre Hospitalo-Universitaire Lille, Lille, France.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Neuzillet', 'Affiliation': 'GERCOR, Paris, France; Department of Medical Oncology, Institut Curie - Site Saint Cloud, Versailles Saint-Quentin University, Paris Saclay University, Saint-Cloud, France. Electronic address: cindy.neuzillet@curie.fr.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.10.027'] 1647,33289072,"FGF23, Frailty, and Falls in SPRINT.","BACKGROUND/OBJECTIVES Chronic kidney disease (CKD) is associated with frailty. Fibroblast growth factor 23 (FGF23) is elevated in CKD and associated with frailty among non-CKD older adults and individuals with human immunodeficiency virus. Whether FGF23 is associated with frailty and falls in CKD is unknown. DESIGN Cross-sectional and longitudinal observational study. SETTING Systolic Blood Pressure Intervention Trial (SPRINT), a randomized trial evaluating standard (systolic blood pressure [SBP] <140 mm Hg) versus intensive (SBP <120 mm Hg) blood pressure lowering on cardiovascular and cognitive outcomes among older adults without diabetes mellitus. PARTICIPANTS A total of 2,376 participants with CKD (estimated glomerular filtration rate [eGFR] <60 mL/min/1.73 m 2 ). MEASUREMENTS The exposure variable was intact FGF23. We used multinomial logistic regression to determine the cross-sectional association of intact FGF23 with frailty and Cox proportional hazards analysis to determine the longitudinal association with incident falls. Models were adjusted for demographics, comorbidities, randomization group, antihypertensives, eGFR, mineral metabolism markers, and frailty. RESULTS After adjustment, the odds ratio for prevalent frailty versus non-frailty per twofold higher FGF23 was 1.34 (95% confidence interval [CI] = 1.01-1.77). FGF23 levels in the highest quartile versus the lowest quartile demonstrated more than a twofold increased fall risk (hazard ratio [HR] = 2.32; 95% CI = 1.26-4.26), and the HR per twofold higher FGF23 was 1.99 (95% CI = 1.48-2.68). CONCLUSION Among SPRINT participants with CKD, FGF23 was associated with prevalent frailty and falls.",2021,Fibroblast growth factor 23 (FGF23) is elevated in CKD and associated with frailty among non-CKD older adults and individuals with human immunodeficiency virus.,"['Chronic kidney disease (CKD', 'non-CKD older adults and individuals with human immunodeficiency virus', 'A total of 2,376 participants with CKD (estimated glomerular filtration rate [eGFR] <60\u2009mL/min/1.73\u2009m 2 ', 'older adults without diabetes mellitus']","['standard (systolic blood pressure [SBP] <140\u2009mm Hg) versus intensive (SBP <120\u2009mm Hg) blood pressure lowering', 'FGF23', 'Fibroblast growth factor 23 (FGF23']","['antihypertensives, eGFR, mineral metabolism markers, and frailty', 'FGF23, Frailty, and Falls in SPRINT', 'FGF23 levels', 'fall risk', 'cardiovascular and cognitive outcomes']","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0962301', 'cui_str': 'Fibroblast growth factor 23'}]","[{'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0962301', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",2376.0,0.115357,Fibroblast growth factor 23 (FGF23) is elevated in CKD and associated with frailty among non-CKD older adults and individuals with human immunodeficiency virus.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Jovanovich', 'Affiliation': 'VA Eastern Colorado Healthcare System, Aurora, Colorado.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Ginsberg', 'Affiliation': 'University of California San Diego, San Diego, California.'}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'You', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Ronit', 'Initials': 'R', 'LastName': 'Katz', 'Affiliation': 'University of Washington, Seattle, Washington.'}, {'ForeName': 'Walter T', 'Initials': 'WT', 'LastName': 'Ambrosius', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Berlowitz', 'Affiliation': 'Boston University, Boston, Massachusetts.'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Cheung', 'Affiliation': 'University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Cho', 'Affiliation': 'Salt Lake City VA Medical Center, Salt Lake City, Utah.'}, {'ForeName': 'Alexandra K', 'Initials': 'AK', 'LastName': 'Lee', 'Affiliation': 'University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Punzi', 'Affiliation': 'Punzi Medical Center, Carrollton, Texas.'}, {'ForeName': 'Shakaib', 'Initials': 'S', 'LastName': 'Rehman', 'Affiliation': 'Phoenix VA Healthcare System, Phoenix, Arizona.'}, {'ForeName': 'Christianne', 'Initials': 'C', 'LastName': 'Roumie', 'Affiliation': 'Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Supiano', 'Affiliation': 'University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Clinton B', 'Initials': 'CB', 'LastName': 'Wright', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, Bethesda, Maryland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Shlipak', 'Affiliation': 'University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Joachim H', 'Initials': 'JH', 'LastName': 'Ix', 'Affiliation': 'University of California San Diego, San Diego, California.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16895'] 1648,33285016,The project COMPASS protocol: Optimizing mindfulness and acceptance-based behavioral treatment for binge-eating spectrum disorders.,"Outcomes from cognitive behavioral therapy for binge-eating spectrum disorders are suboptimal, possibly due in part to deficits in self-regulation (i.e., the ability to control behavior in pursuit of long-term goals despite internal challenges). Mindfulness and acceptance-based treatments (MABTs) integrate behavioral treatment with psychological strategies designed to enhance self-regulation, yet little is known about how and for whom they are effective. The present study will utilize the multiphase optimization strategy to identify which of four MABT components (mindful awareness, distress tolerance, emotion modulation, values-based decision making) to include in a fully powered clinical trial. Participants (n = 256) will be randomized to 16 sessions in one of 16 conditions, each a different combination of MABT components being included or excluded from a base behavioral treatment. Our primary aim is to evaluate each component's independent efficacy on disordered eating symptoms. Our secondary aims are to confirm each component's target engagement (i.e., whether each component improves the targeted variable and outcomes), and test that each component's efficacy is moderated by baseline weaknesses in the same component (e.g., that participants with poor distress tolerance at baseline benefit most from the distress tolerance component). Our exploratory aim is to quantify the component interaction effects.",2021,"Mindfulness and acceptance-based treatments (MABTs) integrate behavioral treatment with psychological strategies designed to enhance self-regulation, yet little is known about how and for whom they are effective.","['binge-eating spectrum disorders', 'Participants (n = 256']","['cognitive behavioral therapy', 'mindfulness and acceptance-based behavioral treatment', 'MABT components being included or excluded from a base behavioral treatment']",[],"[{'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C1143779', 'cui_str': '2-amino-7-deazaadenine'}]",[],256.0,0.0217868,"Mindfulness and acceptance-based treatments (MABTs) integrate behavioral treatment with psychological strategies designed to enhance self-regulation, yet little is known about how and for whom they are effective.","[{'ForeName': 'Adrienne S', 'Initials': 'AS', 'LastName': 'Juarascio', 'Affiliation': 'Department of Psychology, Drexel University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Christina R', 'Initials': 'CR', 'LastName': 'Felonis', 'Affiliation': 'Department of Psychology, Drexel University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Manasse', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Science, Drexel University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Paakhi', 'Initials': 'P', 'LastName': 'Srivastava', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Science, Drexel University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Boyajian', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Science, Drexel University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Evan M', 'Initials': 'EM', 'LastName': 'Forman', 'Affiliation': 'Department of Psychology, Drexel University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Fengqing', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychology, Drexel University, Philadelphia, Pennsylvania, USA.'}]",The International journal of eating disorders,['10.1002/eat.23426'] 1649,33291700,"Acute Effects of Red Chili, a Natural Capsaicin Receptor Agonist, on Gastric Accommodation and Upper Gastrointestinal Symptoms in Healthy Volunteers and Gastroesophageal Reflux Disease Patients.","The effects of chili on gastric accommodation (GA) in gastroesophageal reflux disease (GERD) patients have not been explored. METHODS In total, 15 healthy volunteers (HV) and 15 pH-positive non-erosive GERD (NERD) patients underwent single-photon emission computed tomography after ingesting 2 g of chili or placebo in capsules in a randomized double-blind crossover fashion with a one-week washout period. GA was the maximal postprandial gastric volume (GV) after 250 mL of Ensure ® minus the fasting GV. Upper gastrointestinal symptoms were evaluated by using a visual analog scale. RESULTS NERD patients but not HV had significantly greater GA after chili compared to a placebo (451 ± 89 vs. 375 ± 81 mL, p < 0.05). After chili, the postprandial GVs at 10, 20, and 30 min in NERD patients were significantly greater than HV (10 min, 600 ± 73 vs. 526 ± 70 mL; 20 min, 576 ± 81 vs. 492 ± 78 mL; 30 min, 532 ± 81 vs. 466 ± 86 mL, all p < 0.05). In NERD, chili was associated with significantly less satiety, more severe abdominal burning ( p < 0.05), and a trend of more severe heartburn ( p = 0.06) compared to the placebo. In HV, postprandial symptoms after chili and placebo ingestion were similar ( p > 0.05). CONCLUSIONS Chili enhanced GA in NERD patients but not in HV. This suggests that the modulation of GA in NERD is abnormal and likely involves transient receptor potential vanilloid 1 (TRPV1) sensitive pathways.",2020,"In NERD, chili was associated with significantly less satiety, more severe abdominal burning ( p < 0.05), and a trend of more severe heartburn ( p = 0.06) compared to the placebo.","['Healthy Volunteers and Gastroesophageal Reflux Disease Patients', 'gastroesophageal reflux disease (GERD) patients', '15 healthy volunteers (HV) and 15 pH-positive non-erosive GERD (NERD) patients underwent']","['single-photon emission computed tomography after ingesting 2 g of chili or placebo', 'Red Chili, a Natural Capsaicin Receptor Agonist', 'placebo']","['Upper gastrointestinal symptoms', 'Gastric Accommodation and Upper Gastrointestinal Symptoms', 'maximal postprandial gastric volume (GV', 'GA', 'satiety, more severe abdominal burning', 'postprandial symptoms', 'gastric accommodation (GA', 'postprandial GVs', 'severe heartburn']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0856536', 'cui_str': 'Philadelphia chromosome positive'}, {'cui': 'C0445143', 'cui_str': 'Non-erosive'}]","[{'cui': 'C0040399', 'cui_str': 'Single photon emission computerized tomography'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0108303', 'cui_str': 'Capsaicin Receptors'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0857493', 'cui_str': 'Upper gastrointestinal symptoms'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0006434', 'cui_str': 'Burn injury'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018834', 'cui_str': 'Heartburn'}]",15.0,0.205882,"In NERD, chili was associated with significantly less satiety, more severe abdominal burning ( p < 0.05), and a trend of more severe heartburn ( p = 0.06) compared to the placebo.","[{'ForeName': 'Tanisa', 'Initials': 'T', 'LastName': 'Patcharatrakul', 'Affiliation': 'Center of Excellence on Neurogastroenterology and Motility, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand.'}, {'ForeName': 'Chatchai', 'Initials': 'C', 'LastName': 'Kriengkirakul', 'Affiliation': 'Center of Excellence on Neurogastroenterology and Motility, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand.'}, {'ForeName': 'Tawatchai', 'Initials': 'T', 'LastName': 'Chaiwatanarat', 'Affiliation': 'Division of Nuclear Medicine, Department of Radiology, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand.'}, {'ForeName': 'Sutep', 'Initials': 'S', 'LastName': 'Gonlachanvit', 'Affiliation': 'Center of Excellence on Neurogastroenterology and Motility, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand.'}]",Nutrients,['10.3390/nu12123740'] 1650,33295128,Ultrasound-Guided Erector Spinae Plane Block in Patients Undergoing Laparoscopic Bariatric Surgery: A Prospective Randomized Controlled Trial.,"BACKGROUND Bariatric surgery is frequently complicated with considerable postoperative pain. We evaluated the impact of ultrasound-guided erector spinae plane block on perioperative analgesia and pulmonary functions following laparoscopic bariatric surgery. METHODS A total of 60 patients aged 18 to 65 years with a body mass index (BMI) of ≥ 40 kg/m 2 were randomly allocated into two groups. Patients received either bilateral erector spinae plane block using 20 mL bupivacaine 0.25% at the level of the T7 transverse process or bilateral sham block using 20 mL normal saline on each side. Visual analog scale, intraoperative fentanyl consumption, the cumulative 24-hour postoperative morphine consumption, and postoperative pulmonary functions were recorded. RESULTS Visual analog scale for the first eight postoperative hours were significantly lower in the erector spinae plane block group than the control group. The median (interquartile range [IQR]) intraoperative fentanyl consumption was higher in the control group (159.5 [112.0 to 177.8] μg) than in the erector spinae plane block group (0.0 [0.0 to 74.5] μg) (P < 0.001). The median (IQR) cumulative 24-hour postoperative morphine consumption was lower in the erector spinae plane block group (8.0 [7.0 to 9.0] mg) than in the control group (21.0 [17.0 to 26.25] mg) (P < 0.001, 95% CI [11.00, 15.00]). Postoperative pulmonary functions were significantly impaired in both groups compared with baseline values without significant difference between both groups. CONCLUSION Ultrasound-guided erector spinae plane block provided satisfactory postoperative analgesia following laparoscopic bariatric surgery with decreased analgesic consumption without significant difference in postoperative pulmonary functions compared with the control group.",2021,"The median (IQR) cumulative 24 h postoperative morphine consumption was lower in the erector spinae plane block group [8.0 (7.0 - 9.0) mg] compared to the control group [21.0 (17.0-26.25) mg] (P ˂0.001, 95% CI (11.00, 15.00)).","['60 patients aged 18- 65 years with a BMI of ≥40', 'Patients Undergoing Laparoscopic Bariatric Surgery']","['ultrasound-guided erector spinae plane block', 'Ultrasound-Guided Erector Spinae Plane Block', 'bilateral erector spinae plane block using 20 ml bupivacaine 0.25% at the level of T7 transverse process or bilateral sham block using 20 ml normal saline']","['median (IQR) cumulative 24 h postoperative morphine consumption', 'perioperative analgesia and pulmonary functions', 'Visual Analog Scale', 'median (IQR) intraoperative fentanyl consumption', 'Visual Analog Scale, intraoperative fentanyl consumption, the cumulative 24 h postoperative morphine consumption and postoperative pulmonary functions', 'postoperative pulmonary functions', 'Postoperative pulmonary functions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1096288', 'cui_str': 'Perioperative analgesia'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}]",60.0,0.152187,"The median (IQR) cumulative 24 h postoperative morphine consumption was lower in the erector spinae plane block group [8.0 (7.0 - 9.0) mg] compared to the control group [21.0 (17.0-26.25) mg] (P ˂0.001, 95% CI (11.00, 15.00)).","[{'ForeName': 'Shaimaa F', 'Initials': 'SF', 'LastName': 'Mostafa', 'Affiliation': 'Department of Anaesthesia and Surgical ICU, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mohamed S', 'Initials': 'MS', 'LastName': 'Abdelghany', 'Affiliation': 'Department of Anaesthesia and Surgical ICU, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mohamed M', 'Initials': 'MM', 'LastName': 'Abu Elyazed', 'Affiliation': 'Department of Anaesthesia and Surgical ICU, Faculty of Medicine, Tanta University, Tanta, Egypt.'}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.12975'] 1651,33297773,Can two different pneumococcal conjugate vaccines be used to complete the infant vaccination series? A randomized trial exploring interchangeability of the 13-valent pneumococcal conjugate vaccine and the pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine.,"Background: We assessed the safety and immunogenicity of 2 + 1 infant regimens initiated with the 13-valent pneumococcal conjugate vaccine (PCV13) and completed with the pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV). Methods: This partially blinded study randomized 6-12-week-old infants to receive two-dose priming and a booster (at ages 2, 4, 12-15 months) with: PCV13 at priming and PHiD-CV at boosting (PPS); PCV13 then PHiD-CV at priming and PHiD-CV at boosting (PSS); or PHiD-CV at priming and boosting (SSS control). All analyses were descriptive, i.e., no statistical significance tests were done. Results: The total vaccinated cohort at priming comprised 294 infants. Grade 3 adverse events were reported after 8.7% (PPS), 11.4% (PSS), and 16.9% (SSS) of primary doses (primary objective). No serious adverse events were considered vaccination-related. For most PHiD-CV serotypes, observed percentages of children reaching antibody concentrations ≥0.2 µg/mL and opsonophagocytic activity (OPA) titers above cutoffs were similar across groups 1 month post-priming and post-booster. Observed geometric mean antibody concentrations and OPA titers were lower for some PHiD-CV serotypes with the mixed regimens than with PHiD-CV only, especially for PSS. However, no tests of statistical significance were performed. Conclusions: Immunogenicity of the two mixed PCV13/PHiD-CV regimens seemed mostly similar to that of a PHiD-CV-only series, although observed antibody GMCs and OPA GMTs for some PHiD-CV serotypes were lower. No safety concerns were raised. The clinical relevance of the observed differences is unknown. Clinical trial registration: ClinicalTrials.gov: NCT01641133.",2020,"Observed geometric mean antibody concentrations and OPA titers were lower for some PHiD-CV serotypes with the mixed regimens than with PHiD-CV only, especially for PSS.",['294 infants'],"['13-valent pneumococcal conjugate vaccine and the pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine', '13-valent pneumococcal conjugate vaccine (PCV13) and completed with the pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV', 'PCV13 at priming and PHiD-CV at boosting (PPS']","['serious adverse events', 'geometric mean antibody concentrations and OPA titers', 'safety and immunogenicity', 'opsonophagocytic activity (OPA) titers', 'Grade 3 adverse events']","[{'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C3152625', 'cui_str': 'Pneumococcal 13-valent conjugate vaccine'}, {'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C0138826', 'cui_str': 'glpQ protein, Haemophilus influenzae'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1864445', 'cui_str': 'Histiocytosis-lymphadenopathy plus syndrome'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}]",6.0,0.0832896,"Observed geometric mean antibody concentrations and OPA titers were lower for some PHiD-CV serotypes with the mixed regimens than with PHiD-CV only, especially for PSS.","[{'ForeName': 'Abiel Mascareñas', 'Initials': 'AM', 'LastName': 'de Los Santos', 'Affiliation': 'Universidad Autónoma De Nuevo León , Nuevo León, México.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Rodríguez-Weber', 'Affiliation': 'Instituto Nacional De Pediatría , Mexico D.F., Mexico.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Sánchez-Márquez', 'Affiliation': 'Instituto Nacional De Pediatría , Mexico D.F., Mexico.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Traskine', 'Affiliation': 'Vaccines, GSK , Wavre, Belgium.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Carreño-Manjarrez', 'Affiliation': 'Vaccines, GSK , Mexico D.F., Mexico.'}, {'ForeName': 'María Yolanda', 'Initials': 'MY', 'LastName': 'Cervantes-Apolinar', 'Affiliation': 'Vaccines, GSK , Mexico D.F., Mexico.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Strezova', 'Affiliation': 'Vaccines, GSK , Wavre, Belgium.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Ruiz-Guiñazú', 'Affiliation': 'Vaccines, GSK , Wavre, Belgium.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Ortega-Barria', 'Affiliation': 'Vaccines, GSK , Panama City, Panama.'}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Borys', 'Affiliation': 'Vaccines, GSK , Wavre, Belgium.'}]",Expert review of vaccines,['10.1080/14760584.2020.1843431'] 1652,33300183,"Week 96 resistance analyses of the once-daily, single-tablet regimen (STR) darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in adults living with HIV-1 from the phase 3 randomized AMBER and EMERALD trials.","In AMBER and EMERALD, darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg demonstrated high virological response and low virological failure (VF) through week 96. Week 96 resistance analyses are presented. Post-baseline samples for genotyping/phenotyping were analyzed from protocol-defined-VFs with viral load (VL) ≥ 400 copies/ml at failure/later time points. Post-hoc analyses were deep sequencing (AMBER) and HIV-1 proviral DNA sequencing from baseline samples (VL < 50 copies/ml) (EMERALD). Through week 96 across studies, no darunavir, primary protease inhibitor (PI), or tenofovir resistance-associated-mutations (RAMs) occurred in patients continuing (N = 1125) or switching to D/C/F/TAF (N = 715). M184I/V (emtricitabine RAM) was detected in one patient in each arm of AMBER. In EMERALD D/C/F/TAF patients with prior VF and baseline genoarchive data (N = 98), 4% had darunavir RAMs, 36% emtricitabine RAMs, mainly at position 184 (32%), 4% tenofovir RAMs, and 19% ≥3 thymidine-analogue-associated-mutations at screening. The predicted phenotype showed 0% had reduced susceptibility to darunavir, 37% to emtricitabine, and 22% to tenofovir. All achieved VL < 50 copies/ml at week 96/prior discontinuation, with no VF. D/C/F/TAF has a high barrier to resistance; no darunavir, primary PI, or tenofovir RAMs occurred through 96 weeks in AMBER and EMERALD. In EMERALD, baseline archived darunavir, emtricitabine, and tenofovir RAMs in patients with prior VF did not preclude virologic response.",2021,M184I/V (emtricitabine RAM) was detected in one patient in each arm of AMBER.,['adults living with HIV-1 from the phase 3 randomized AMBER'],"['Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF', 'Single-tablet Regimen (STR', 'emtricitabine/tenofovir alafenamide (D/C/F/TAF', 'tenofovir', 'M184I/V (emtricitabine RAM']","['virologic response', 'virological response and low virological failure (VF', 'protease inhibitor (PI) or tenofovir resistance-associated-mutations (RAMs']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0242864', 'cui_str': 'Amber'}]","[{'cui': 'C3871454', 'cui_str': 'darunavir and cobicistat'}, {'cui': 'C4059167', 'cui_str': 'emtricitabine and tenofovir alafenamide'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C1519302', 'cui_str': 'Short Tandem Repeats'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0526951', 'cui_str': 'ramosetron hydrochloride'}]","[{'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0033607', 'cui_str': 'Peptide hydrolase inhibitor'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}]",,0.0587468,M184I/V (emtricitabine RAM) was detected in one patient in each arm of AMBER.,"[{'ForeName': 'Erkki', 'Initials': 'E', 'LastName': 'Lathouwers', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Weinsteiger', 'Affiliation': 'Janssen Scientific Affairs, LLC, Titusville, New Jersey, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Baugh', 'Affiliation': 'Janssen Research & Development LLC, Raritan, New Jersey, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Ghys', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Jezorwski', 'Affiliation': 'Janssen Research & Development, Pennington, New Jersey, USA.'}, {'ForeName': 'El Ghazi', 'Initials': 'EG', 'LastName': 'Mohsine', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Van Landuyt', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'De Meyer', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}]",Journal of medical virology,['10.1002/jmv.26721'] 1653,33302991,Anakinra treatment in critically ill COVID-19 patients: a prospective cohort study.,"BACKGROUND A subset of critically ill COVID-19 patients develop a hyperinflammatory state. Anakinra, a recombinant interleukin-1 receptor antagonist, is known to be effective in several hyperinflammatory diseases. We investigated the effects of anakinra on inflammatory parameters and clinical outcomes in critically ill, mechanically ventilated COVID-19 patients with clinical features of hyperinflammation. METHODS In this prospective cohort study, 21 critically ill COVID-19 patients treated with anakinra were compared to a group of standard care. Serial data of clinical inflammatory parameters and concentrations of multiple circulating cytokines were determined and aligned on start day of anakinra in the treatment group, and median start day of anakinra in the control group. Analysis was performed for day - 10 to + 10 relative to alignment day. Clinical outcomes were analyzed during 28 days. Additionally, three sensitivity analyses were performed: (1) using propensity score-matched groups, (2) selecting patients who did not receive corticosteroids, and (3) using a subset of the control group aimed to match the criteria (fever, elevated ferritin) for starting anakinra treatment. RESULTS Baseline patient characteristics and clinical parameters on ICU admission were similar between groups. As a consequence of bias by indication, plasma levels of aspartate aminotransferase (ASAT) (p = 0.0002), ferritin (p = 0.009), and temperature (p = 0.001) were significantly higher in the anakinra group on alignment day. Following treatment, no relevant differences in kinetics of circulating cytokines were observed between both groups. Decreases of clinical parameters, including temperature (p = 0.03), white blood cell counts (p = 0.02), and plasma levels of ferritin (p = 0.003), procalcitonin (p = 0.001), creatinine (p = 0.01), and bilirubin (p = 0.007), were more pronounced in the anakinra group. No differences in duration of mechanical ventilation or ICU length of stay were observed between groups. Sensitivity analyses confirmed these results. CONCLUSIONS Anakinra is effective in reducing clinical signs of hyperinflammation in critically ill COVID-19 patients. A randomized controlled trial is warranted to draw conclusion about the effects of anakinra on clinical outcomes.",2020,"Decreases of clinical parameters, including temperature (p = 0.03), white blood cell counts (p = 0.02), and plasma levels of ferritin (p = 0.003), procalcitonin (p = 0.001), creatinine (p = 0.01), and bilirubin (p = 0.007), were more pronounced in the anakinra group.","['critically ill COVID-19 patients', '21 critically ill COVID-19 patients treated with anakinra were compared to a group of standard care', 'critically ill, mechanically ventilated COVID-19 patients with clinical features of hyperinflammation']",[],"['ICU admission', 'plasma levels of aspartate aminotransferase (ASAT', 'plasma levels of ferritin', 'white blood cell counts', 'duration of mechanical ventilation or ICU length of stay', 'kinetics of circulating cytokines', 'bilirubin']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",[],"[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}]",21.0,0.0989329,"Decreases of clinical parameters, including temperature (p = 0.03), white blood cell counts (p = 0.02), and plasma levels of ferritin (p = 0.003), procalcitonin (p = 0.001), creatinine (p = 0.01), and bilirubin (p = 0.007), were more pronounced in the anakinra group.","[{'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Kooistra', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, 6500HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Nicole J B', 'Initials': 'NJB', 'LastName': 'Waalders', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, 6500HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Grondman', 'Affiliation': 'Radboud Center for Infectious Diseases, Radboud University Medical Center, 6500HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Nico A F', 'Initials': 'NAF', 'LastName': 'Janssen', 'Affiliation': 'Radboud Center for Infectious Diseases, Radboud University Medical Center, 6500HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Aline H', 'Initials': 'AH', 'LastName': 'de Nooijer', 'Affiliation': 'Radboud Center for Infectious Diseases, Radboud University Medical Center, 6500HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Mihai G', 'Initials': 'MG', 'LastName': 'Netea', 'Affiliation': 'Radboud Center for Infectious Diseases, Radboud University Medical Center, 6500HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'van de Veerdonk', 'Affiliation': 'Radboud Center for Infectious Diseases, Radboud University Medical Center, 6500HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Ewalds', 'Affiliation': 'Department of Intensive Care Medicine, Bernhoven Hospital, 5406PT, Uden, The Netherlands.'}, {'ForeName': 'Johannes G', 'Initials': 'JG', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, 6500HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Kox', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, 6500HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Pickkers', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, 6500HB, Nijmegen, The Netherlands. peter.pickkers@radboudumc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Critical care (London, England)",['10.1186/s13054-020-03364-w'] 1654,29864109,Total Sleep Deprivation and Recovery Sleep Affect the Diurnal Variation of Agility Performance: The Gender Differences.,"ABSTRACT Romdhani, M, Hammouda, O, Smari, K, Chaabouni, Y, Mahdouani, K, Driss, T, and Souissi, N. Total sleep deprivation and recovery sleep affect the diurnal variation of agility performance: The gender differences. J Strength Cond Res 35(1): 132-140, 2021-This study aimed to investigate the effects of time-of-day, 24 and 36 hours of total sleep deprivation (TSD), and recovery sleep (RS) on repeated-agility performances. Twenty-two physical education students (11 male and 11 female students) completed 5 repeated modified agility T-test (RMAT) sessions (i.e., 2 after normal sleep night [NSN] [at 07:00 and 17:00 hours], 2 after TSD [at 07:00 hours, i.e., 24-hour TSD and at 17:00 hours, i.e., 36-hour TSD], and 1 after RS at 17:00 hours). The RMAT index decreased from the morning to the afternoon after NSN (p < 0.05, d = 1.05; p < 0.01, d = 0.73) and after TSD (p < 0.001, d = 0.92; d = 1.08), respectively, for total time (TT) and peak time (PT). This finding indicates a diurnal variation in repeated agility, which persisted after TSD. However, the diurnal increase in PT was less marked in the female group after NSN (2.98 vs. 6.24%). Moreover, TT and PT increased, respectively, after 24-hour TSD (p < 0.001; d = 0.84, d = 0.87) and 36-hour TSD (p < 0.001, d = 1.12; p < 0.01, d = 0.65). Female subjects' PT was less affected by 24-hour TSD (1.76 vs. 6.81%) compared with male subjects' PT. After 36-hour TSD, the amount of decrease was not different between groups, which increased the diurnal amplitude of PT only for male subjects. Total sleep deprivation suppressed the diurnal increase of PT and increased the diurnal amplitude of oral temperature only in women. Nevertheless, RS normalized the sleep-loss-induced performance disruption. Conclusively, sleep loss and RS differently affect repeated-agility performance of men and women during the day. Sleep extension postdeprivation could have potent restorative effect on repeated-agility performances, and female subjects could extract greater benefits.",2021,"The RMAT index decreased from the morning to the afternoon after NSN (p < 0.05, d = 1.05; p < 0.01, d = 0.73) and after TSD (p < 0.001, d = 0.92; d = 1.08), respectively, for total time (TT) and peak time (PT).",['Twenty-two physical education students (11 male and 11 female students) completed'],['5 repeated modified agility T-test (RMAT) sessions'],"['total time (TT) and peak time (PT', 'diurnal increase in PT', 'Total sleep deprivation', 'RMAT index', 'Total Sleep Deprivation and Recovery Sleep Affect the Diurnal Variation of Agility Performance', 'diurnal amplitude of PT', 'total sleep deprivation (TSD), and recovery sleep (RS) on repeated-agility performances', 'diurnal amplitude of oral temperature']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0008810', 'cui_str': 'Circadian rhythm'}, {'cui': 'C1532216', 'cui_str': 'Oral temperature'}]",,0.0223144,"The RMAT index decreased from the morning to the afternoon after NSN (p < 0.05, d = 1.05; p < 0.01, d = 0.73) and after TSD (p < 0.001, d = 0.92; d = 1.08), respectively, for total time (TT) and peak time (PT).","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Romdhani', 'Affiliation': 'National Observatory of Sports, Exercise Physiology Departement, Tunis, Tunisia.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Hammouda', 'Affiliation': 'Research Center on Sport and Movement (CeRSM), UFP STAPS, University of Paris Nanterre, France.'}, {'ForeName': 'Khawla', 'Initials': 'K', 'LastName': 'Smari', 'Affiliation': 'High Institute of Sport and Physical Education Ksar-Said, Departement of Biology, Manouba University, Manouba, Tunisia.'}, {'ForeName': 'Yassine', 'Initials': 'Y', 'LastName': 'Chaabouni', 'Affiliation': 'Department of Biochemistry, CHU Ibn Jazzar, Kairouan, Tunisia; and.'}, {'ForeName': 'Kacem', 'Initials': 'K', 'LastName': 'Mahdouani', 'Affiliation': 'Department of Biochemistry, CHU Ibn Jazzar, Kairouan, Tunisia; and.'}, {'ForeName': 'Tarak', 'Initials': 'T', 'LastName': 'Driss', 'Affiliation': 'Research Center on Sport and Movement (CeRSM), UFP STAPS, University of Paris Nanterre, France.'}, {'ForeName': 'Nizar', 'Initials': 'N', 'LastName': 'Souissi', 'Affiliation': 'National Observatory of Sports, Exercise Physiology Departement, Tunis, Tunisia.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002614'] 1655,33331088,MR Measures of Small Bowel Wall T2 Are Associated With Increased Permeability.,"BACKGROUND Increased small bowel permeability leads to bacterial translocation, associated with significant morbidity and mortality. Biomarkers are needed to evaluate these changes in vivo, stratify an individual's risk, and evaluate the efficacy of interventions. MRI is an established biomarker of small bowel inflammation. PURPOSE To characterize changes in the small bowel with quantitative MRI measures associated with increased permeability induced by indomethacin. STUDY TYPE Prospective single-center, double-blind, two-way crossover provocation study. SUBJECTS A provocation cohort (22 healthy volunteers) and intrasubject reproducibility cohort (8 healthy volunteers). FIELD STRENGTH/SEQUENCE 2D balanced turbo field echo sequences to measure small bowel wall thickness, T 2 , and motility acquired at 3T. ASSESSMENT Participants were randomized to receive indomethacin or placebo prior to assessment. After a minimum 2-week washout, measures were repeated with the alternative allocation. MR measures (wall thickness, T 2 , motility) at each study visit were compared to the reference standard 2-hour lactulose/mannitol urinary excretion ratio (LMR) test performed by a lab technician. All analyses were performed blind. STATISTICAL TESTS Normality was tested (Shapiro-Wilk's test). Paired testing (Student's t-test or Wilcoxon) determined the significance of paired differences with indomethacin provocation. Pearson's correlation coefficient compared significant measures with indomethacin provocation to LMR. Intrasubject (intraclass correlation) and interrater variability (Bland-Altman) were assessed. RESULTS Indomethacin provocation induced a significant increase in LMR compared to placebo (P < 0.05) and a significant increase in small bowel T 2 (0.12 seconds compared to placebo 0.07 seconds, P < 0.05). Small bowel wall thickness (P = 0.17) and motility (P = 0.149) showed no significant change. T 2 and LMR were positively correlated (r = 0.68, P < 0.05). T 2 measurements were robust to interobserver (intraclass correlation 0.89) and intrasubject variability (Bland-Altman bias of 0.005 seconds, 95% confidence interval [CI] -0.04 to +0.05 seconds, and 0.0006 seconds, 95% CI -0.05 to +0.06 seconds). DATA CONCLUSION MR measures of small bowel wall T 2 were significantly increased following indomethacin provocation and correlated with 2-hour LMR test results. LEVEL OF EVIDENCE 1 TECHNICAL EFFICACY STAGE: 2.",2021,Small bowel wall thickness (P = 0.17) and motility (P = 0.149) showed no significant change.,['A provocation cohort (22 healthy volunteers) and intrasubject reproducibility cohort (8 healthy volunteers'],"['indomethacin', 'indomethacin or placebo', 'placebo']","['interrater variability (Bland-Altman', 'MR measures of small bowel wall T 2', 'Small bowel wall thickness', 'motility', 'small bowel T 2', 'MR measures (wall thickness, T 2 , motility', 'LMR', 'mannitol urinary excretion ratio (LMR) test', 'T 2 and LMR', 'intrasubject variability']","[{'cui': 'C0449428', 'cui_str': 'Provocation'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",22.0,0.0537468,Small bowel wall thickness (P = 0.17) and motility (P = 0.149) showed no significant change.,"[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Scott', 'Affiliation': 'National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre at the Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Hannah G', 'Initials': 'HG', 'LastName': 'Williams', 'Affiliation': 'National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre at the Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Caroline L', 'Initials': 'CL', 'LastName': 'Hoad', 'Affiliation': 'National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre at the Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Alyami', 'Affiliation': 'National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre at the Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Ortori', 'Affiliation': 'Centre for Analytical Bioscience, School of Pharmacy, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Jane I', 'Initials': 'JI', 'LastName': 'Grove', 'Affiliation': 'National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre at the Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Marciani', 'Affiliation': 'National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre at the Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Gordon W', 'Initials': 'GW', 'LastName': 'Moran', 'Affiliation': 'National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre at the Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Robin C', 'Initials': 'RC', 'LastName': 'Spiller', 'Affiliation': 'National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre at the Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Menys', 'Affiliation': 'Motilent Ltd, London, UK.'}, {'ForeName': 'Guruprasad P', 'Initials': 'GP', 'LastName': 'Aithal', 'Affiliation': 'National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre at the Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Penny A', 'Initials': 'PA', 'LastName': 'Gowland', 'Affiliation': 'National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre at the Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham, UK.'}]",Journal of magnetic resonance imaging : JMRI,['10.1002/jmri.27463'] 1656,33288410,Association of counselor weight status and demographics with participant weight loss in a structured lifestyle intervention.,"OBJECTIVE There is substantial variability in the effectiveness of group lifestyle interventions for weight loss. We examined associations between intervention weight loss counselors and participant weight loss and program engagement in a structured lifestyle intervention. METHODS Data were from 575 adults (87% female, 51 (12) years, baseline BMI: 32.4 (7.2) kg/m 2 ) in an 11-week structured group lifestyle program. Participants self-enrolled in groups led by 11 weight loss counselors based on meeting times. All weight loss counselors received the same training. Linear mixed models were used to evaluate counselor predictors of participant percent (%) weight loss and program engagement (weight reporting throughout 11 weeks). RESULTS Of the 575 participants, 415 (72%) defined as complete reporters, i.e. reported weight weekly, lost a mean 7.3% weight (range: +3.1% to 16.2%). Participant weight loss differed between weight loss counselors (p = 0.003), and adjusted mean participant weight loss by weight loss counselor ranged from 6% to 9%. Weight loss was greater for weight loss counselors with a graduate degree in nutrition than weight loss counselors with another graduate degree (8.3% versus 6.4%, p = 0.05), but was not different between weight loss counselors with and without graduate degrees. Higher counselor BMI was associated with higher participant weight loss (p = 0.005). CONCLUSIONS These results demonstrate the potential for quantitatively important effects of weight loss counselor characteristics on participant success and engagement in structured lifestyle interventions, indicating a need for research in this area.",2021,"Weight loss was greater for weight loss counselors with a graduate degree in nutrition than weight loss counselors with another graduate degree (8.3% versus 6.4%, p = 0.05), but was not different between weight loss counselors with and without graduate degrees.","['Participants self-enrolled in groups led by 11 weight loss counselors based on meeting times', 'Data were from 575 adults (87% female, 51 (12) years, baseline BMI: 32.4 (7.2)\u202fkg/m 2 ) in an 11-week structured group lifestyle program']",[],"['Higher counselor BMI', 'participant weight loss', 'Weight loss', 'Participant weight loss']","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1571885', 'cui_str': 'Professional counselor'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3844102', 'cui_str': '575'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517709', 'cui_str': '32.4'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1571885', 'cui_str': 'Professional counselor'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",575.0,0.0125591,"Weight loss was greater for weight loss counselors with a graduate degree in nutrition than weight loss counselors with another graduate degree (8.3% versus 6.4%, p = 0.05), but was not different between weight loss counselors with and without graduate degrees.","[{'ForeName': 'Maria Carlota', 'Initials': 'MC', 'LastName': 'Dao', 'Affiliation': 'Energy Metabolism Laboratory, USDA Human Nutrition Research Center on Aging at Tufts University, 711 Washington St., Boston, MA 02111, United States. Electronic address: Carlota.Dao@unh.edu.'}, {'ForeName': 'Sai Krupa', 'Initials': 'SK', 'LastName': 'Das', 'Affiliation': 'Energy Metabolism Laboratory, USDA Human Nutrition Research Center on Aging at Tufts University, 711 Washington St., Boston, MA 02111, United States.'}, {'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Silver', 'Affiliation': 'Energy Metabolism Laboratory, USDA Human Nutrition Research Center on Aging at Tufts University, 711 Washington St., Boston, MA 02111, United States.'}, {'ForeName': 'Susan B', 'Initials': 'SB', 'LastName': 'Roberts', 'Affiliation': 'Energy Metabolism Laboratory, USDA Human Nutrition Research Center on Aging at Tufts University, 711 Washington St., Boston, MA 02111, United States.'}]",Obesity research & clinical practice,['10.1016/j.orcp.2020.11.005'] 1657,33288404,Intravenous Mannitol reduces intracompartmental pressure following tibia fractures: A randomized controlled trial.,"PURPOSE Impending compartment syndrome is a common event following closed tibia fractures, which can progress to sinister compartment syndrome. Fasciotomy is the only definitive treatment available, though it has its own drawbacks and complications. Medical management at present consists of limb elevation and adequate hydration. This study aims at determining whether intravenous administration of Mannitol reduced the intracompartmental pressure in patients with closed tibial fractures. METHODS This is a double blinded, randomized control trial done in a single tertiary care center in India. Forty-five patients were recruited between February 2012 and October 2012. Forty patients who presented to the emergency department with isolated, closed, high velocity, and proximal 2/3 tibia fractures were included in this study. Patients with contraindication to Mannitol were excluded. They were allocated into 2 groups by the investigator using computer generated randomization. The pressure in the anterior compartment of the leg was measured with a handheld Stryker pressure monitor. Then either 20% Mannitol or 0.9% normal saline as given intravenously in a blinded manner, based on the randomization. The intracompartmental pressure was measured at 0, 1 and 3 h after the infusion. The participant, investigator and statistician were masked to the group assessment. RESULTS There was no difference in intracompartmental pressures at 1 or 3 h, between the groups. However, in patients with the baseline of compartmental pressures ≥30 mmHg, Mannitol showed a marked reduction in pressure of 8.5 mmHg at 1 h compared to almost no change in pressure in the saline group. There were no adverse events with the use of Mannitol. CONCLUSIONS This preliminary study appears to show that Mannitol is useful in the management of the increased compartment pressure. The limitations of this study were that it only involved a small group of patients and the baseline pressures in both the groups were not comparable. More studies are required before the use of Mannitol as a standard of care in the management of compartment syndrome can be established.",2021,"There was no difference in intracompartmental pressures at 1 or 3 hours, between the groups.","['single tertiary care center in India', 'tibia fractures', 'patients with closed tibial fractures', 'Patients with contraindication to Mannitol were excluded', 'Forty patients who presented to the emergency department with isolated, closed, high velocity, and proximal 2/3 tibia fractures', 'Forty-five patients were recruited between February 2012 and October 2012']","['Mannitol', 'Mannitol or 0.9% normal saline', 'Intravenous Mannitol']","['intracompartmental pressures', 'intracompartmental pressure', 'adverse events']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0040185', 'cui_str': 'Fracture of tibia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C4319567', 'cui_str': '45'}]","[{'cui': 'C0024730', 'cui_str': 'Mannitol'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0439166', 'cui_str': '% normal'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",45.0,0.116079,"There was no difference in intracompartmental pressures at 1 or 3 hours, between the groups.","[{'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Nesaraj', 'Affiliation': 'Christian Medical College, Vellore 632004, Tamil Nadu, India.'}, {'ForeName': 'Viju Daniel', 'Initials': 'VD', 'LastName': 'Varghese', 'Affiliation': 'Christian Medical College, Vellore 632004, Tamil Nadu, India.'}, {'ForeName': 'P R', 'Initials': 'PR', 'LastName': 'Boopalan', 'Affiliation': 'Royal Darwin Hospital, Darwin 0810, Northern Territory, Australia.'}, {'ForeName': 'Manasseh', 'Initials': 'M', 'LastName': 'Nithyananth', 'Affiliation': 'Christian Medical College, Vellore 632004, Tamil Nadu, India.'}, {'ForeName': 'Thambu David', 'Initials': 'TD', 'LastName': 'Sudarsanam', 'Affiliation': 'Christian Medical College, Vellore 632004, Tamil Nadu, India.'}, {'ForeName': 'Thilak Samuel', 'Initials': 'TS', 'LastName': 'Jepegnanam', 'Affiliation': 'Christian Medical College, Vellore 632004, Tamil Nadu, India. Electronic address: jepegnanamt@cmcvellore.ac.in.'}]",Chinese journal of traumatology = Zhonghua chuang shang za zhi,['10.1016/j.cjtee.2020.11.006'] 1658,33293342,Risk of Cervical Intraepithelial Neoplasia Grade 3 or Worse in HPV-Positive Women with Normal Cytology and Five-Year Type Concordance: A Randomized Comparison.,"BACKGROUND In human papillomavirus (HPV)-based cervical screening programs, management of HPV-positive women with normal cytology is debated. Longitudinal information on HPV type persistence may be employed for risk stratification. METHODS We assessed the risk of cervical intraepithelial neoplasia grade 3 or worse (CIN3+) after repeatedly testing positive for the same HPV type(s) in the randomized population-based screening study Amsterdam (POBASCAM). We compared 18-month CIN3+ risks in HPV-positive women (intervention, n = 1,066) to those in HPV-positive/cytology-negative women who tested HPV-positive in the next screening round (control, n = 111) five years later, stratified for HPV type concordance. RESULTS The 18-month CIN3+ risk was 15% in HPV-positive women in the intervention group, 40% in the control group after two-round type concordance (relative risk 2.6, 95% confidence interval 1.9-3.4), and 20% in the control group after a type switch (1.3, 0.5-3.2). The relative increase in CIN3+ risk after two-round type concordance was similar in <35-year-old (3.0, 2.0-4.4) and older women (2.2, 1.4-3.5), and was high in high-risk HPV-positive women who were HPV16/18/31/33/45-negative in both rounds (9.9, 4.4-21.9). CONCLUSIONS Five-year HPV type concordance signals high CIN3+ risk and warrants referral for colposcopy without additional cytology triage. IMPACT HPV screening programs become highly efficient when HPV-positive women with negative triage testing at baseline are offered repeat HPV genotyping after five years.",2021,"The 18-month CIN3+ risk was 15% in HPV-positive women in the intervention group, 40% in the control group after two-round type concordance (relative risk 2.6, 95% confidence interval 1.9-3.4) and 20% in the control group after a type switch (1.3, 0.5-3.2).","['HPV-positive women (intervention, n=1 066) to those in HPV-positive/cytology-negative women who tested HPV-positive in the next screening round (control, n=111) five years later, stratified for HPV type concordance', 'cervical intraepithelial neoplasia grade 3 or worse in HPV-positive women with normal cytology and five-year type concordance']",['human papillomavirus (HPV)-based cervical screening programs'],"['CIN3+ risk', '18-month CIN3+ risk', 'risk of cervical intraepithelial grade 3 or worse (CIN3']","[{'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010818', 'cui_str': 'Cytology'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0851140', 'cui_str': 'Carcinoma in situ of uterine cervix'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0205307', 'cui_str': 'Normal'}]","[{'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0851140', 'cui_str': 'Carcinoma in situ of uterine cervix'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}]",,0.287793,"The 18-month CIN3+ risk was 15% in HPV-positive women in the intervention group, 40% in the control group after two-round type concordance (relative risk 2.6, 95% confidence interval 1.9-3.4) and 20% in the control group after a type switch (1.3, 0.5-3.2).","[{'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Inturrisi', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Epidemiology and Data Science, Amsterdam Public Health, Amsterdam, the Netherlands. f.inturrisi@amsterdamumc.nl.'}, {'ForeName': 'Johannes A', 'Initials': 'JA', 'LastName': 'Bogaards', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Epidemiology and Data Science, Amsterdam Public Health, Amsterdam, the Netherlands.'}, {'ForeName': 'Daniëlle A M', 'Initials': 'DAM', 'LastName': 'Heideman', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Pathology, Cancer Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Chris J L M', 'Initials': 'CJLM', 'LastName': 'Meijer', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Pathology, Cancer Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Berkhof', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Epidemiology and Data Science, Amsterdam Public Health, Amsterdam, the Netherlands.'}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-20-1336'] 1659,33298762,Impact of Streptococcus salivarius K12 on Nasopharyngeal and Saliva Microbiome: A Randomized Controlled Trial.,"BACKGROUND Probiotic lactobacilli have been ineffective in preventing acute otitis media. In contrast to lactobacilli, alpha-hemolytic streptococci belong to the core microbiome of nasopharynx. METHODS We investigated the effects of Streptococcus salivarius K12 probiotic on the saliva and nasopharyngeal microbiome in 121 children attending daycare. Children were randomly allocated to receive oral K12 product for 1 month or no treatment. We obtained saliva and nasopharyngeal samples at study entry, at 1 and 2 months. The next-generation sequencing of the bacterial 16S gene was performed. RESULTS After the intervention, the diversity of saliva or nasopharyngeal microbiome did not differ between groups. The proportion of children with any otopathogen did not differ between the groups. At 1 month, the abundance of otopathogens in nasopharynx was lower in K12 group compared with that in control children (34% vs. 55%, P = 0.037). When we compared each otopathogen separately, Moraxella was the only group lower in the treatment group. We could not verify the reduction of Moraxella when an alternative Human Oral Microbiome Database taxonomy database was used. In children receiving K12 product, the mean abundance of S. salivarius was greater in saliva after the intervention (0.9% vs. 2.0%, P = 0.009). CONCLUSIONS The use of S. salivarius K12 probiotic appeared to be safe because it did not disrupt the normal microbiome in young children. Even though a short-term colonization of S. salivarius was observed in the saliva, the impact of S. salivarius K12 probiotic on the otopathogens in nasopharyngeal microbiome remained uncertain.",2021,"In children receiving K12 product, the mean abundance of S. salivarius was greater in saliva after the intervention (0.9% vs. 2.0%, P = 0.009). ","['121 children attending daycare', 'young children']","['Streptococcus salivarius K12 probiotic', 'Streptococcus salivarius K12', 'oral K12 product for 1 month or no treatment']","['abundance of otopathogens in nasopharynx', 'proportion of children with any otopathogen', 'diversity of saliva or nasopharyngeal microbiome', 'mean abundance of S. salivarius']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}]","[{'cui': 'C0318179', 'cui_str': 'Streptococcus salivarius'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",121.0,0.0578652,"In children receiving K12 product, the mean abundance of S. salivarius was greater in saliva after the intervention (0.9% vs. 2.0%, P = 0.009). ","[{'ForeName': 'Suvi', 'Initials': 'S', 'LastName': 'Sarlin', 'Affiliation': 'From the Department of Pediatrics and Adolescent Medicine, Oulu University Hospital.'}, {'ForeName': 'Mysore V', 'Initials': 'MV', 'LastName': 'Tejesvi', 'Affiliation': 'Genetics and Physiology, Faculty of Science, University of Oulu.'}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Turunen', 'Affiliation': 'Genetics and Physiology, Faculty of Science, University of Oulu.'}, {'ForeName': 'Petri', 'Initials': 'P', 'LastName': 'Vänni', 'Affiliation': 'Genetics and Physiology, Faculty of Science, University of Oulu.'}, {'ForeName': 'Tytti', 'Initials': 'T', 'LastName': 'Pokka', 'Affiliation': 'From the Department of Pediatrics and Adolescent Medicine, Oulu University Hospital.'}, {'ForeName': 'Marjo', 'Initials': 'M', 'LastName': 'Renko', 'Affiliation': 'PEDEGO Research Unit and Medical Research Center Oulu.'}, {'ForeName': 'Terhi', 'Initials': 'T', 'LastName': 'Tapiainen', 'Affiliation': 'From the Department of Pediatrics and Adolescent Medicine, Oulu University Hospital.'}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000003016'] 1660,33305031,Investigating the effect of transcendental meditation on spiritual wellbeing of Type-2 diabetic amputees: A clinical trial study.,"Objectives Diabetes is a chronic, progressive and life-threatening metabolic syndrome that causes physical complications such as amputation, psychological complications and crisis in one's life, which leads to increased expression of spirituality and increased use of spiritual support as a coping mechanism. The aim of the present study was to investigate the effect of spiritual care on the spiritual wellbeing of type-2 diabetic amputees. Materials and methods In the present clinical trial study, 54 type-2 diabetic amputees were randomly divided into two groups; namely, experimental and control in 2014 and underwent transcendental meditation (TM) in three sessions. The 20-item spiritual well-being scale (SWBS) (Paloutzian and Ellision), which measures the spiritual well-being dimensions, was completed by patients before and after the intervention. Data analysis was performed using descriptive and inferential methods (paired T-test, independent t-test, Fisher's exact test, mann-whitney test, and chi-square) in SPSS ver. 16. Results The results showed no statistically significant difference between the experimental and control groups in terms of mean spiritual wellbeing before the intervention, but, the post-intervention mean spiritual wellbeing score in the control and experimental groups was 97.82 ± 9.25 and 88.40 ± 9.47, respectively. (α = 0.05) (P = 0.001). Conclusion According to the results of the present study, it seems that spiritual care is able to improve the spiritual wellbeing status of individuals.",2020,"The results showed no statistically significant difference between the experimental and control groups in terms of mean spiritual wellbeing before the intervention, but, the post-intervention mean spiritual wellbeing score in the control and experimental groups was 97.82 ± 9.25 and 88.40 ± 9.47, respectively.","['Type-2 diabetic amputees', '54 type-2 diabetic amputees', 'type-2 diabetic amputees']","['spiritual care', 'transcendental meditation (TM', 'transcendental meditation']","['20-item spiritual well-being scale (SWBS) (Paloutzian and Ellision), which measures the spiritual well-being dimensions', 'mean spiritual wellbeing', 'post-intervention mean spiritual wellbeing score']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0002695', 'cui_str': 'Amputee'}]","[{'cui': 'C0150355', 'cui_str': 'Spiritual support'}, {'cui': 'C0150814', 'cui_str': 'Transcendental meditation'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3697375', 'cui_str': 'Spiritual wellbeing'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.026694,"The results showed no statistically significant difference between the experimental and control groups in terms of mean spiritual wellbeing before the intervention, but, the post-intervention mean spiritual wellbeing score in the control and experimental groups was 97.82 ± 9.25 and 88.40 ± 9.47, respectively.","[{'ForeName': 'Ali Heydari', 'Initials': 'AH', 'LastName': 'Movahed', 'Affiliation': 'Student Research Committee, School of Public Health, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Fakhri', 'Initials': 'F', 'LastName': 'Sabouhi', 'Affiliation': 'Nursing and Midwifery Care Research Center, Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Mohammadpourhodki', 'Affiliation': 'Kashmar Center of Higher Health Education, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Mahdavi', 'Affiliation': 'Department of Epidemiology, School of Public Health, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Goudarzian', 'Affiliation': 'Goldis Hospital, Shahinshahr, Isfahan, Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Amerian', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Mohtashami', 'Affiliation': 'Department of Anesthesiology, School of Allied Medicine, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Mansoure', 'Initials': 'M', 'LastName': 'Kheiri', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Imeni', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Shahroud University of Medical Sciences, Shahroud, Iran.'}]",Heliyon,['10.1016/j.heliyon.2020.e05567'] 1661,33301814,Long-term Service Use Among Youths Previously Treated for Anxiety Disorder.,"OBJECTIVE (1) To describe rates of long-term service use among subjects previously enrolled in a landmark study of youth anxiety disorder treatment and followed into early adulthood; (2) to examine predictors of long-term service use; and (3) to examine the relationship between anxiety diagnosis and service use over time. METHOD The Child/Adolescent Anxiety Multimodal Extended Long-term Study prospectively assessed youths treated through the Child/Adolescent Anxiety Multimodal Study at ages 7-17 years into early adulthood. A total of 319 youths (mean age 17.7, 55.2% female) previously randomized to cognitive-behavioral therapy, sertraline, combination, or placebo for the treatment of anxiety participated; 318 had service use data. Four annual clinic assessments were conducted along with telephone check-ins every 6 months. RESULTS Overall, 65.1% of participants endorsed receiving some form of anxiety treatment over the course of the follow-up period, with more subjects reporting medication use than psychotherapy; 35.2% reported consistent use of services over the course of the study. Overall, service use declined over time in subjects with less severe anxiety but remained more steady in those with recurrent/chronic symptoms. Levels of life stress and depressive symptoms were associated with amount of service use over time whereas treatment-related variables (type of initial intervention, acute response, remission) were not. A subset of youths remained chronically anxious despite consistent service use. CONCLUSION These findings point to the need to develop models of care that approach anxiety disorders as chronic health conditions in need of active long-term management.",2021,"Overall, service use declined over time in subjects with less severe anxiety but remained more steady in those with recurrent/chronic symptoms.","['Youth', 'subjects previously enrolled in a landmark study of youth anxiety disorder treatment and followed into early adulthood; (2', 'The Child/Adolescent Anxiety Multi-modal Extended Long-term Study (CAMELS) prospectively assessed youth treated through the Child/Adolescent Anxiety Multimodal Study (CAMS) at ages 7 to 17 years into early adulthood', '319 youth (mean age =17.7; 55.2% female']","['cognitive-behavioral therapy (CBT), sertraline (SRT), combination (COMB) or placebo (PBO']","['Levels of life stress and depressive symptoms', 'severe anxiety']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0700597', 'cui_str': 'Adulthood'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517598', 'cui_str': '17.7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0231403', 'cui_str': 'Severe anxiety (panic)'}]",,0.0300577,"Overall, service use declined over time in subjects with less severe anxiety but remained more steady in those with recurrent/chronic symptoms.","[{'ForeName': 'Tara S', 'Initials': 'TS', 'LastName': 'Peris', 'Affiliation': 'University of California, Los Angeles. Electronic address: tperis@mednet.ucla.edu.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Sugar', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Rozenman', 'Affiliation': 'University of Denver, Colorado.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Walkup', 'Affiliation': ""Robert and Ann Lurie Children's Hospital, Chicago, Illinois.""}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Albano', 'Affiliation': 'Columbia University, New York.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Compton', 'Affiliation': 'Duke University, Durham, North Carolina.'}, {'ForeName': 'Dara', 'Initials': 'D', 'LastName': 'Sakolsky', 'Affiliation': 'Western Psychiatric Institute and Clinic, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Golda', 'Initials': 'G', 'LastName': 'Ginsburg', 'Affiliation': 'University of Connecticut, Mansfield.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Keeton', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Kendall', 'Affiliation': 'Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'McCracken', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Piacentini', 'Affiliation': 'University of California, Los Angeles.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2020.07.911'] 1662,33307206,Effects of Yoga in Daily Life program in rheumatoid arthritis: A randomized controlled trial.,"OBJECTIVES To explore the feasibility and effectiveness of a yoga program in improving health-related quality of life (HQOL), physical and psychological functioning in rheumatoid arthritis (RA) patients. DESIGN Single-centre parallel-arms randomized controlled trial comparing yoga (n = 30) and education control group (n = 27). SETTING Tertiary care University hospital. INTERVENTION A 12-week yoga program, based on the Yoga in Daily Life system, included 2x weekly/90-minute sessions. The control group had 1xweekly/60-minute educational lectures on arthritis-related topics. MAIN OUTCOME MEASURES Assessments were performed at baseline, 12 (post-intervention) and 24 weeks (follow-up). The primary outcome was change in The Short Form-36 (SF-36) HQOL at 12 weeks. Linear regression analysis was adjusted for baseline scores. RESULTS No significant between-group differences were found for SF-36 (all p > 0.05). At 12 weeks the adjusted mean difference between groups favoured yoga for Functional Assessment of Chronic Illness Therapy-fatigue (5.08 CI 1.29 to 8.86; p = 0.009) and Hospital Anxiety and Depression Scale (HADS)-depression (-1.37 CI -2.38 to -0.36); p = 0.008) and at 24 weeks for HADS-anxiety (-1.79 CI -3.34 to - 0.23; p = 0.025), while the impact on fatigue was sustained (5.43 CI 1.33 to 9.54, p = 0.01). The program had no impact on RA disease activity. Feasibility outcomes included recruitment rate 16 %, retention 80.7 %, and adherence to yoga 87.5 vs 82.7 % for control. No serious adverse events were recorded. CONCLUSIONS Yoga in Daily Life program was not associated with change in health-related quality of life of RA patients. Significant improvements in fatigue and mood were observed at postintervention and follow-up. This yoga program was found feasible and safe for patients and may complement standard RA treat-to-target strategy.",2021,At 12 weeks the adjusted mean difference between groups favoured yoga for Functional Assessment of Chronic Illness Therapy-fatigue (5.08 CI 1.29 to 8.86; p = 0.009) and Hospital Anxiety and Depression Scale (HADS)-depression (,"['rheumatoid arthritis', 'rheumatoid arthritis (RA) patients', 'Tertiary care University hospital']","['Yoga in Daily Life program', 'yoga program', '1xweekly/60-minute educational lectures', 'trialcomparing yoga (n\u2009=\u200930) and education control group (n\u2009=\u200927']","['RA disease activity', 'serious adverse events', 'fatigue and mood', 'fatigue', 'recruitment rate 16 %, retention 80.7 %, and adherence', 'Functional Assessment of Chronic Illness Therapy-fatigue', 'health-related quality of life (HQOL), physical and psychological functioning', 'HADS-anxiety', 'health-related quality of life', 'Short Form-36 (SF-36) HQOL', 'SF-36', 'Hospital Anxiety and Depression Scale (HADS)-depression ']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.173808,At 12 weeks the adjusted mean difference between groups favoured yoga for Functional Assessment of Chronic Illness Therapy-fatigue (5.08 CI 1.29 to 8.86; p = 0.009) and Hospital Anxiety and Depression Scale (HADS)-depression (,"[{'ForeName': 'Silva', 'Initials': 'S', 'LastName': 'Pukšić', 'Affiliation': 'Department of Clinical Immunology, Allergology and Rheumatology, Department of Internal Medicine, School of Medicine University of Zagreb, Dubrava University Hospital, Avenija Gojka Šuška 6, 10 000, Zagreb, Croatia. Electronic address: puksic.silva@gmail.com.'}, {'ForeName': 'Joško', 'Initials': 'J', 'LastName': 'Mitrović', 'Affiliation': 'Department of Clinical Immunology, Allergology and Rheumatology, Department of Internal Medicine, School of Medicine University of Zagreb, Dubrava University Hospital, Avenija Gojka Šuška 6, 10 000, Zagreb, Croatia.'}, {'ForeName': 'Melanie-Ivana', 'Initials': 'MI', 'LastName': 'Čulo', 'Affiliation': 'Department of Clinical Immunology, Allergology and Rheumatology, Department of Internal Medicine, School of Medicine University of Zagreb, Dubrava University Hospital, Avenija Gojka Šuška 6, 10 000, Zagreb, Croatia.'}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Živković', 'Affiliation': 'Clinical Department of Laboratory Diagnostics, Dubrava University Hospital, Avenija Gojka Šuška 6, 10 000, Zagreb, Croatia.'}, {'ForeName': 'Biserka', 'Initials': 'B', 'LastName': 'Orehovec', 'Affiliation': 'Clinical Department of Laboratory Diagnostics, Dubrava University Hospital, Avenija Gojka Šuška 6, 10 000, Zagreb, Croatia.'}, {'ForeName': 'Dubravka', 'Initials': 'D', 'LastName': 'Bobek', 'Affiliation': 'Department of Physical Medicine and Rehabilitation with Rheumatology, Dubrava University Hospital, Avenija Gojka Šuška 6, 10 000, Zagreb, Croatia.'}, {'ForeName': 'Jadranka', 'Initials': 'J', 'LastName': 'Morović-Vergles', 'Affiliation': 'Department of Clinical Immunology, Allergology and Rheumatology, Department of Internal Medicine, School of Medicine University of Zagreb, Dubrava University Hospital, Avenija Gojka Šuška 6, 10 000, Zagreb, Croatia.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102639'] 1663,33601032,"Response to the comments received on article ""Efficacy and safety of favipiravir, an oral RNA-dependent RNA polymerase inhibitor, in mild-to-moderate COVID-19: A randomized, comparative, open-label, multicenter, phase 3 clinical trial"" by Udwadia et al.",,2021,,['mild-to-moderate COVID-19'],"['favipiravir, an oral RNA-dependent RNA polymerase inhibitor']",[],"[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C1138226', 'cui_str': 'favipiravir'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0035685', 'cui_str': 'RNA-directed RNA polymerase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]",[],,0.0271678,,"[{'ForeName': 'Zarir F', 'Initials': 'ZF', 'LastName': 'Udwadia', 'Affiliation': 'Breach Candy Hospital, Mumbai, India.'}, {'ForeName': 'Hanmant', 'Initials': 'H', 'LastName': 'Barkate', 'Affiliation': 'Glenmark Pharmaceuticals Limited, Mumbai, India.'}, {'ForeName': 'Saiprasad', 'Initials': 'S', 'LastName': 'Patil', 'Affiliation': 'Glenmark Pharmaceuticals Limited, Mumbai, India.'}, {'ForeName': 'Shabbir', 'Initials': 'S', 'LastName': 'Rangwala', 'Affiliation': 'Glenmark Pharmaceuticals Limited, Mumbai, India.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Glenmark Pharmaceuticals Ltd, Watford, UK.'}, {'ForeName': 'Cynthia F', 'Initials': 'CF', 'LastName': 'Caracta', 'Affiliation': 'Glenmark Pharmaceuticals, Inc., Mahwah, NJ, USA.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Tandon', 'Affiliation': 'Glenmark Pharmaceuticals Limited, Mumbai, India. Electronic address: Monika.Tandon@glenmarkpharma.com.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2021.02.028'] 1664,33316278,Cervical cancer risk and screening among women seeking assistance with basic needs.,"BACKGROUND In the United States, more than half of cervical cancers occur in women who are inadequately screened. Interventions to improve access to cervical cancer preventive care is critical to reduce health inequities. OBJECTIVE This study aimed to evaluate the need for cervical cancer screening among women seeking assistance with basic needs and to assess best approaches to facilitate Papanicolaou test referral. STUDY DESIGN This study is a secondary analysis of a randomized controlled trial of low-income female callers to 2-1-1 Missouri, a helpline for local health and social services. The need for cervical cancer screening was assessed. Callers were randomized to 1 of 3 arms, each providing a Papanicolaou test referral: verbal referral only, verbal referral and tailored print reminder, or verbal referral and navigator. The primary outcome was contacting a Papanicolaou test referral 1 month following intervention. Student t tests or Mann-Whitney U tests were used to analyze significant differences in continuous variables, whereas Fisher exact or χ 2 tests were used for categorical variables. We stratified by number of unmet basic needs (0-1 vs ≥2) and compared success of contacting a Papanicolaou test referral among study groups (verbal referral vs tailored reminder vs navigator) using the Fisher exact test and χ 2 test, respectively. Multivariate logistic regression was used to assess risk factors for nonadherence for Papanicolaou test at baseline and at 1 month follow-up, adjusting for race and ethnicity, age, insurance status, self-rated health, smoking, and study group. RESULTS Among 932 female callers, 250 (26.8%) needed cervical cancer screening. The frequency of unmet basic needs was high, the most common being lack of money for unexpected expenses (91.2%) and necessities, such as food, shelter, and clothing (73.2%). Among those needing a Papanicolaou test, 211 women received screening referrals. Women in the navigator group (21 of 71, 29.6%) reported higher rates of contacting a Papanicolaou test referral than those exposed to verbal referral only (11/73, 15.1%) or verbal referral and tailored print reminder (9/67, 13.4%) (P=.03). Among 176 women with ≥2 unmet needs who received a Papanicolaou test referral, the provision of a navigator remained associated with contacting the referral (navigator [33.9%] vs verbal referral [17.2%] vs tailored reminder [10.2%]; P=.005). Assignment to the navigator group (adjusted odds ratio, 3.4; 95% confidence interval, 1.4-8.5) and nonwhite race (adjusted odds ratio, 2.0; 95% confidence interval, 1.5-2.8) were independent predictors of contacting a Papanicolaou test referral. CONCLUSION Low-income women seeking assistance with basic needs often lack cervical cancer screening. Health navigators triple the likelihood that women will make contact with Papanicolaou test services, but most 2-1-1 callers still fail to schedule Papanicolaou testing despite assistance from navigators. Interventions beyond health navigators are needed to reduce cervical cancer disparities.",2021,"Women in the navigator group (11/73, 15.1%) reported higher rates of contacting a Pap referral than those exposed to verbal referral only (9/67, 13.4%) or verbal referral+tailored print reminder (21/71, 29.6%), p = 0.03.","['176 women with ≥ 2 unmet needs who received a Pap referral, provision of a navigator remained associated with contacting the referral (33.9% vs. verbal referral 17.2% vs. tailored reminder 10.2%, p=0.005', 'low-income female callers to Missouri 2-1-1, a helpline for local health/social services', 'women seeking assistance with basic needs', '932 female callers, 26.8% needed cervical screening']","['Pap referral: verbal referral only, verbal referral+ tailored print reminder, or verbal referral+navigator']","['Cervical cancer risk and screening', 'higher rates of contacting a Pap referral', 'odds ratio (aOR', 'Pap referral one month post-intervention']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C4517718', 'cui_str': '33.9'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0026222', 'cui_str': 'Missouri'}, {'cui': 'C1449035', 'cui_str': 'SPRR2A protein, human'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0033161', 'cui_str': 'Printing'}]","[{'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",176.0,0.0911297,"Women in the navigator group (11/73, 15.1%) reported higher rates of contacting a Pap referral than those exposed to verbal referral only (9/67, 13.4%) or verbal referral+tailored print reminder (21/71, 29.6%), p = 0.03.","[{'ForeName': 'Lindsay M', 'Initials': 'LM', 'LastName': 'Kuroki', 'Affiliation': 'Division of Gynecologic Oncology, Washington University School of Medicine, St. Louis, MO. Electronic address: kurokil@wustl.edu.'}, {'ForeName': 'L Stewart', 'Initials': 'LS', 'LastName': 'Massad', 'Affiliation': 'Division of Gynecologic Oncology, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Woolfolk', 'Affiliation': 'Division of Clinical Research, Department of Obstetrics and Gynecology, Washington University, St. Louis, MO.'}, {'ForeName': 'Tess', 'Initials': 'T', 'LastName': 'Thompson', 'Affiliation': 'Health Communication Research Laboratory, Brown School of Social Work, Washington University, St. Louis, MO.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'McQueen', 'Affiliation': 'Health Communication Research Laboratory, Brown School of Social Work, Washington University, St. Louis, MO.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Kreuter', 'Affiliation': 'Health Communication Research Laboratory, Brown School of Social Work, Washington University, St. Louis, MO.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.12.018'] 1665,33319443,Study protocol for a multisite randomized controlled trial of an internet and mobile-based intervention for preventing and reducing perinatal depressive symptoms.,"Nearly 20% of women in the United States experience clinically significant depressive symptoms during pregnancy or the postpartum period. These women may benefit from easily accessible, nonpharmacologic, and inexpensive self-management approaches, such as via internet and mobile-based interventions, to prevent development of symptoms and/or intervene with current symptoms. This paper summarizes the research protocol of a nationally-funded large-scale randomized controlled study to evaluate ""Mamma Mia,"" a self-guided program with 44 modules that women use throughout pregnancy to 6 months postpartum. The program contains a novel combination of components designed to enable women to enhance self-efficacy, emotional self-regulation, and perceived social support. The overall goal of this three-arm longitudinal randomized controlled trial is to evaluate the effects and mechanisms of this self-management approach in diverse women in the U.S. (n = 1950). Enrolled pregnant women will be randomly assigned to one of three groups: (1) ""Mamma Mia"" alone, which is self-guided; (2) ""Mamma Mia Plus"" in which participants engage in the ""Mamma Mia"" modules plus receive brief guided support from a registered nurse; or (3) usual prenatal/postpartum care. The first specific aim is to evaluate effects by group on the primary outcome of interest, depressive symptoms, over time. The second aim is to evaluate effects by group on subjective well-being, anxiety, and stress. Using a conceptual framework based upon Individual and Family Self-Management Theory, the third aim is to evaluate possible mediators (self-efficacy, emotion self-regulation, perceived support) and possible moderators (e.g., race/ethnicity, type of healthcare clinician) of this self-management approach.",2021,"The program contains a novel combination of components designed to enable women to enhance self-efficacy, emotional self-regulation, and perceived social support.","['Enrolled pregnant women', 'diverse women in the U.S. (n\u2009=\u20091950']","['Mamma Mia"" alone, which is self-guided; (2) ""Mamma Mia Plus"" in which participants engage in the ""Mamma Mia"" modules plus receive brief guided support from a registered nurse; or (3) usual prenatal/postpartum care', 'internet and mobile-based intervention']","['depressive symptoms', 'subjective well-being, anxiety, and stress', 'perinatal depressive symptoms']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}]",,0.10726,"The program contains a novel combination of components designed to enable women to enhance self-efficacy, emotional self-regulation, and perceived social support.","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Kinser', 'Affiliation': 'Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Jallo', 'Affiliation': 'Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Huberty', 'Affiliation': 'College of Health Solutions, Arizona State University, Tempe, Arizona, USA.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Jones', 'Affiliation': 'Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Leroy', 'Initials': 'L', 'LastName': 'Thacker', 'Affiliation': 'Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Moyer', 'Affiliation': 'Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Breanne', 'Initials': 'B', 'LastName': 'Laird', 'Affiliation': 'College of Health Solutions, Arizona State University, Tempe, Arizona, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Rider', 'Affiliation': 'Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Lanni', 'Affiliation': 'Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Drozd', 'Affiliation': 'Regional Centre for Child and Adolescent Mental Health, Oslo, Norway.'}, {'ForeName': 'Silje', 'Initials': 'S', 'LastName': 'Haga', 'Affiliation': 'Regional Centre for Child and Adolescent Mental Health, Oslo, Norway.'}]",Research in nursing & health,['10.1002/nur.22092'] 1666,33319386,An interactive technology enhanced coaching intervention for Black women with hypertension: Randomized controlled trial study protocol.,"In the United States, hypertension (HTN) is the leading risk factor for cardiovascular disease, and a more significant health problem for Blacks compared with other racial/ethnic groups. The prevalence of HTN in Black women is among the highest in the world, underscoring the need for effective prevention and management approaches for blood pressure (BP) control. We developed a two-arm randomized controlled trial repeated measures design study for improving HTN self-management among Black women. The study tests whether the Chronic Disease Self-Management Program (CDSMP) combined with interactive technology-enhanced coaching, can improve BP control and adherence to treatment (e.g., medication-taking, physical activity, calorie intake, and weight management) compared with the CDSMP alone. Repeated measurements were conducted at 3, 6, and 9 months. A sample of 90 community-dwelling Black women with uncontrolled Stage 1 HTN (BP ≥ 130/80) were enrolled, completed CDSMP training, and randomized. This study will contribute to our understanding of novel methods to empower Black women to increase their active involvement in self-care management of HTN.",2021,This study will contribute to our understanding of novel methods to empower Black women to increase their active involvement in self-care management of HTN.,"['Black women with hypertension', 'empower Black women', '90 community-dwelling Black women with uncontrolled Stage 1 HTN (BP\u2009≥\u2009130/80', 'Black women']","['interactive technology enhanced coaching intervention', 'CDSMP alone', 'Chronic Disease Self-Management Program (CDSMP) combined with interactive technology-enhanced coaching', 'CDSMP training']","['BP control and adherence to treatment (e.g., medication-taking, physical activity, calorie intake, and weight management', 'blood pressure (BP) control']","[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1290952', 'cui_str': 'Taking medication'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}]",90.0,0.0603735,This study will contribute to our understanding of novel methods to empower Black women to increase their active involvement in self-care management of HTN.,"[{'ForeName': 'Willie M', 'Initials': 'WM', 'LastName': 'Abel', 'Affiliation': 'School of Nursing, College of Health and Human Services, The University of North Carolina at Charlotte, Charlotte, North Carolina, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'DeHaven', 'Affiliation': 'Department of Public Health Sciences, College of Health and Human Services, The University of North Carolina at Charlotte, Charlotte, North Carolina, USA.'}]",Research in nursing & health,['10.1002/nur.22090'] 1667,33323209,The effect of digital physical activity interventions on daily step count: a randomised controlled crossover substudy of the MyHeart Counts Cardiovascular Health Study.,"BACKGROUND Smartphone apps might enable interventions to increase physical activity, but few randomised trials testing this hypothesis have been done. The MyHeart Counts Cardiovascular Health Study is a longitudinal smartphone-based study with the aim of elucidating the determinants of cardiovascular health. We aimed to investigate the effect of four different physical activity coaching interventions on daily step count in a substudy of the MyHeart Counts Study. METHODS In this randomised, controlled crossover trial, we recruited adults (aged ≥18 years) in the USA with access to an iPhone smartphone (Apple, Cupertino, CA, USA; version 5S or newer) who had downloaded the MyHeart Counts app (version 2.0). After completion of a 1 week baseline period of interaction with the MyHeart Counts app, participants were randomly assigned to receive one of 24 permutations (four combinations of four 7 day interventions) in a crossover design using a random number generator built into the app. Interventions consisted of either daily prompts to complete 10 000 steps, hourly prompts to stand following 1 h of sitting, instructions to read the guidelines from the American Heart Association website, or e-coaching based upon the individual's personal activity patterns from the baseline week of data collection. Participants completed the trial in a free-living setting. Due to the nature of the interventions, participants could not be masked from the intervention. Investigators were not masked to intervention allocation. The primary outcome was change in mean daily step count from baseline for each of the four interventions, assessed in the modified intention-to-treat analysis set, which included all participants who had completed 7 days of baseline monitoring and at least 1 day of one of the four interventions. This trial is registered with ClinicalTrials.gov, NCT03090321. FINDINGS Between Dec 12, 2016, and June 6, 2018, 2783 participants consented to enrol in the coaching study, of whom 1075 completed 7 days of baseline monitoring and at least 1 day of one of the four interventions and thus were included in the modified intention-to-treat analysis set. 493 individuals completed the full set of assigned interventions. All four interventions significantly increased mean daily step count from baseline (mean daily step count 2914 [SE 74]): mean step count increased by 319 steps (75) for participants in the American Heart Association website prompt group (p<0·0001), 267 steps (74) for participants in the hourly stand prompt group (p=0·0003), 254 steps (74) for participants in the cluster-specific prompts group (p=0·0006), and by 226 steps (75) for participants in the 10 000 daily step prompt group (p=0·0026 vs baseline). INTERPRETATION Four smartphone-based physical activity coaching interventions significantly increased daily physical activity. These findings suggests that digital interventions delivered via a mobile app have the ability to increase short-term physical activity levels in a free-living cohort. FUNDING Stanford Data Science Initiative.",2019,"All four interventions significantly increased mean daily step count from baseline (mean daily step count 2914 [SE 74]): mean step count increased by 319 steps (75) for participants in the American Heart Association website prompt group (p<0·0001), 267 steps (74) for participants in the hourly stand prompt group (p=0·0003), 254 steps (74) for participants in the cluster-specific prompts group (p=0·0006), and by 226 steps (75) for participants in the 10 000 daily step prompt group (p=0·0026 vs baseline). ","['493 individuals', 'Between Dec 12, 2016, and June 6, 2018, 2783 participants consented to enrol in the coaching study, of whom 1075 completed 7 days of baseline monitoring and at least 1 day of one of the four interventions and thus were included in the modified intention-to-treat analysis set', 'recruited adults (aged ≥18 years) in the USA with access to an iPhone smartphone (Apple, Cupertino, CA, USA; version 5S or newer) who had downloaded the MyHeart Counts app (version 2.0']","['smartphone-based physical activity coaching interventions', 'digital physical activity interventions', 'physical activity coaching interventions']","['mean daily step count', 'daily physical activity', 'daily step count', 'short-term physical activity levels']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0003625', 'cui_str': 'Malus'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",2783.0,0.194658,"All four interventions significantly increased mean daily step count from baseline (mean daily step count 2914 [SE 74]): mean step count increased by 319 steps (75) for participants in the American Heart Association website prompt group (p<0·0001), 267 steps (74) for participants in the hourly stand prompt group (p=0·0003), 254 steps (74) for participants in the cluster-specific prompts group (p=0·0006), and by 226 steps (75) for participants in the 10 000 daily step prompt group (p=0·0026 vs baseline). ","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Shcherbina', 'Affiliation': 'Department of Biomedical Data Science, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Hershman', 'Affiliation': 'Division of Cardiovascular Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lazzeroni', 'Affiliation': 'Department of Biomedical Data Science, Stanford University, Stanford, CA, USA; Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA; Department of Veterans Affairs Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'Abby C', 'Initials': 'AC', 'LastName': 'King', 'Affiliation': 'Division of Cardiovascular Medicine, Stanford University, Stanford, CA, USA; Department of Health Research and Policy and Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Jack W', 'Initials': 'JW', 'LastName': ""O'Sullivan"", 'Affiliation': 'Division of Cardiovascular Medicine, Stanford University, Stanford, CA, USA; Meta-Research Innovation Center at Stanford, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Hekler', 'Affiliation': 'Center for Wireless and Population Health Systems, University of California in San Diego, San Diego, CA, USA.'}, {'ForeName': 'Yasbanoo', 'Initials': 'Y', 'LastName': 'Moayedi', 'Affiliation': 'Division of Cardiovascular Medicine, Stanford University, Stanford, CA, USA; Ted Rogers Centre for Heart Research, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Pavlovic', 'Affiliation': 'Division of Cardiovascular Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Daryl', 'Initials': 'D', 'LastName': 'Waggott', 'Affiliation': 'Division of Cardiovascular Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Abhinav', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Division of Cardiovascular Medicine, Stanford University, Stanford, CA, USA; Department of Cardiology, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Yeung', 'Affiliation': 'Division of Cardiovascular Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Jeffrey W', 'Initials': 'JW', 'LastName': 'Christle', 'Affiliation': 'Division of Cardiovascular Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Wheeler', 'Affiliation': 'Division of Cardiovascular Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'McConnell', 'Affiliation': 'Division of Cardiovascular Medicine, Stanford University, Stanford, CA, USA; Verily Life Sciences, San Francisco, CA, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Harrington', 'Affiliation': 'Division of Cardiovascular Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Euan A', 'Initials': 'EA', 'LastName': 'Ashley', 'Affiliation': 'Department of Biomedical Data Science, Stanford University, Stanford, CA, USA; Division of Cardiovascular Medicine, Stanford University, Stanford, CA, USA. Electronic address: euan@stanford.edu.'}]",The Lancet. Digital health,['10.1016/S2589-7500(19)30129-3'] 1668,33325785,Safety and immunogenicity of an adjuvanted Escherichia coli adhesin vaccine in healthy women with and without histories of recurrent urinary tract infections: results from a first-in-human phase 1 study.,"Antibiotic resistance among gram-negative bacteria continues to rise globally at an alarming rate. New vaccines that prevent bacterial infections and reduce antibiotic use could provide a potential solution to these problems. This study focused on development of an investigational vaccine to prevent recurrent urinary traction infections (UTI) caused by gram-negative bacteria that use type 1 pili to adhere to, invade, and colonize human bladders. The vaccine antigen is FimH, an adhesin protein on the tip of type 1 pili with a lectin binding domain that enables attachment to glycoproteins on mammalian bladders. This was a phase 1, open-label, dose escalation study evaluating the vaccine in 67 healthy women with and without histories of recurrent UTI. The objectives of the study were to evaluate the safety, tolerability, and immunogenicity of different dosages of the antigen and adjuvant of the vaccine. All dosages were well-tolerated and a low incidence of systemic reactions occurred. No serious adverse events related to the vaccine were reported. The vaccine induced both binding and functional antibodies. The women with histories of recurrent UTI demonstrated greater than 150-fold increases in antibodies against the N-terminal region of FimH. Based on the results of this phase 1 study, this vaccine is proceeding to a double-blind, randomized, placebo-controlled phase 2 study. If this vaccine is successful in future studies, it could potentially prevent millions of recurrent UTI globally and reduce the development of antibiotic resistance.",2021,"The women with histories of recurrent UTI demonstrated greater than 150-fold increases in antibodies against the N-terminal region of FimH. Based on the results of this phase 1 study, this vaccine is proceeding to a double-blind, randomized, placebo-controlled phase 2 study.","['67 healthy women with and without histories of recurrent UTI', 'healthy women with and without histories of recurrent urinary tract infections']","['adjuvanted Escherichia coli adhesin vaccine', 'investigational vaccine', 'placebo']","['Antibiotic resistance', 'safety, tolerability, and immunogenicity', 'Safety and immunogenicity', 'systemic reactions']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0040597', 'cui_str': 'Traction'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C3532611', 'cui_str': 'History of recurrent urinary tract infection'}]","[{'cui': 'C0050830', 'cui_str': 'Adhesin, Escherichia coli'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0949285', 'cui_str': 'Antibiotic Resistance'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",67.0,0.10234,"The women with histories of recurrent UTI demonstrated greater than 150-fold increases in antibodies against the N-terminal region of FimH. Based on the results of this phase 1 study, this vaccine is proceeding to a double-blind, randomized, placebo-controlled phase 2 study.","[{'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Eldridge', 'Affiliation': 'Sequoia Sciences, Inc., St. Louis, MO, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Hughey', 'Affiliation': 'Sequoia Sciences, Inc., St. Louis, MO, USA.'}, {'ForeName': 'Lois', 'Initials': 'L', 'LastName': 'Rosenberger', 'Affiliation': 'LBR Regulatory and Clinical Consulting Services, Inc, Florence, KY, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Martin', 'Affiliation': 'Sequoia Sciences, Inc., St. Louis, MO, USA.'}, {'ForeName': 'Andrew Marc', 'Initials': 'AM', 'LastName': 'Shapiro', 'Affiliation': 'Lifebridge Health, Owings Mills, MD, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': ""D'Antonio"", 'Affiliation': 'AA Urology, Annapolis, MD, USA.'}, {'ForeName': 'Kent G', 'Initials': 'KG', 'LastName': 'Krejci', 'Affiliation': 'AA Urology, Annapolis, MD, USA.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Shore', 'Affiliation': 'Atlantic Urology Clinics, Myrtle Beach, SC, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Peterson', 'Affiliation': 'J. Lewis Research, Salt Lake City, UT, USA.'}, {'ForeName': 'Andrea S', 'Initials': 'AS', 'LastName': 'Lukes', 'Affiliation': ""Women's Wellness Clinic, Carolina Women's Research and Wellness Center (CWRWC), Durham, NC, USA.""}, {'ForeName': 'Courtney M', 'Initials': 'CM', 'LastName': 'Starks', 'Affiliation': 'Sequoia Sciences, Inc., St. Louis, MO, USA.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2020.1834807'] 1669,33331261,"Cellular dehydration acutely degrades mood mainly in women: a counterbalanced, crossover trial.",,2021,,['Cellular dehydration acutely degrades mood mainly in women'],[],[],"[{'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],[],,0.0630219,,"[{'ForeName': 'HyunGyu', 'Initials': 'H', 'LastName': 'Suh', 'Affiliation': ''}, {'ForeName': 'Harris R', 'Initials': 'HR', 'LastName': 'Liebermann', 'Affiliation': ''}, {'ForeName': 'Lisa T', 'Initials': 'LT', 'LastName': 'Jansen', 'Affiliation': ''}, {'ForeName': 'Abigail T', 'Initials': 'AT', 'LastName': 'Colburn', 'Affiliation': ''}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Adams', 'Affiliation': ''}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'Seal', 'Affiliation': ''}, {'ForeName': 'Cory L', 'Initials': 'CL', 'LastName': 'Butts', 'Affiliation': ''}, {'ForeName': 'Tracie M', 'Initials': 'TM', 'LastName': 'Kirkland', 'Affiliation': ''}, {'ForeName': 'Olle', 'Initials': 'O', 'LastName': 'Melander', 'Affiliation': ''}, {'ForeName': 'Tiphaine', 'Initials': 'T', 'LastName': 'Vanhaecke', 'Affiliation': ''}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Doci', 'Affiliation': ''}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Lemetais', 'Affiliation': ''}, {'ForeName': 'Erica T', 'Initials': 'ET', 'LastName': 'Perrier', 'Affiliation': ''}, {'ForeName': 'Stavros A', 'Initials': 'SA', 'LastName': 'Kavouras', 'Affiliation': ''}]",The British journal of nutrition,['10.1017/S0007114520004444'] 1670,33331207,Treatment of Femoropopliteal Lesions With the BioMimics 3D Vascular Stent System: Two-Year Results From the MIMICS-2 Trial.,"PURPOSE To report the safety and effectiveness outcomes through 2 years of the BioMimics 3D Vascular Stent System in the treatment of symptomatic patients with atherosclerotic femoropopliteal disease. MATERIALS AND METHODS The tubular, nitinol BioMimics 3D stent, which was designed to impart a helical shape to the arterial segment, was implanted in 271 patients (mean age 68.4±9.5 years; 180 men) with de novo femoropopliteal lesions enrolled at 43 investigational sites [31 US (n=162), 6 German (n=78), and 6 Japanese (n=31)] in the prospective, single-arm MIMICS-2 investigational device exemption trial ( ClinicalTrials.gov identifier NCT02400905) between June 2015 and October 2016. Mean lesion length was 81.2±38.4 mm, 30.0% of patients had total occlusions, and 45.9% had moderate to severe calcification. Primary safety and effectiveness endpoints were compared at 1 year with prespecified objective performance goals (OPGs) set by the VIVA Physicians organization. Outcomes through 2 years are reported. RESULTS The primary effectiveness endpoint of 12-month primary stent patency was met by 182 of 249 patients (73.1%, 95% CI 67.3% to 78.2%), exceeding the OPG of 66%. The primary safety endpoint of 30-day freedom from major adverse events (MAEs) was met in 268 of 269 patients (99.6%, 95% CI 97.7% to 100%), exceeding the OPG of 88%. Kaplan-Meier estimates of freedom from loss of primary patency were 83.1% at 12 months and 70.2% at 24 months, freedom from MAEs estimates were 86.9% at 12 months and 79.2% at 24 months, and freedom from clinically-driven target lesion revascularization estimates were 88.0% at 12 months and 83.0% at 24 months. At 24 months, 88.2% of patients showed improvement of ≥1 Rutherford category; the ankle-brachial index was >0.9 for 64.4% vs 11.3% at baseline. There were no cases of stent fracture. CONCLUSION Through 24 months, the BioMimics 3D Vascular Stent System provided safe and effective treatment for femoropopliteal lesions in patients with symptomatic peripheral artery disease.",2021,"Mean lesion length was 81.2±38.4 mm, 30.0% of patients had total occlusions, and 45.9% had moderate to severe calcification.","['patients with symptomatic peripheral artery disease', '271 patients (mean age 68.4±9.5 years; 180 men) with de novo femoropopliteal lesions enrolled at 43 investigational sites [31 US (n=162), 6 German (n=78), and 6 Japanese (n=31)] in the prospective, single-arm MIMICS-2 investigational device exemption trial ( ClinicalTrials.gov identifier NCT02400905) between June 2015 and October 2016', 'symptomatic patients with atherosclerotic femoropopliteal disease']",['BioMimics 3D Vascular Stent System'],"['ankle-brachial index', 'Mean lesion length', 'total occlusions', 'stent fracture', '12-month primary stent patency', '30-day freedom from major adverse events (MAEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0249550', 'cui_str': 'neurotensin mimic 2'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0183521', 'cui_str': 'Vascular stent'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C1328319', 'cui_str': 'Ankle brachial pressure index'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0449591', 'cui_str': 'Stent patency'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",271.0,0.0741146,"Mean lesion length was 81.2±38.4 mm, 30.0% of patients had total occlusions, and 45.9% had moderate to severe calcification.","[{'ForeName': 'Timothy M', 'Initials': 'TM', 'LastName': 'Sullivan', 'Affiliation': 'Section of Vascular/Endovascular Surgery, Minneapolis Heart Institute at Abbott Northwestern, Minneapolis, MN, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Zeller', 'Affiliation': 'Department of Angiology, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Gaines', 'Affiliation': 'Sheffield Vascular Institute, Northern General Hospital, Sheffield, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists,['10.1177/1526602820980419'] 1671,33336889,Sedation for bronchoscopy in children: A prospective randomized double-blinded trial.,"INTRODUCTION In pediatric patients, flexible bronchoscopy requires deep sedation. Different sedation regimes are common, but only some of them include opioids. Due to their antitussive effect, the use of short-acting opioids may be beneficial for this particular indication, but additional respiratory depression may lead to an increase in adverse events. Here, we systematically compared sedation regimes in children undergoing flexible bronchoscopy with either propofol alone, or a combination of propofol and remifentanil. The primary outcome parameter was the frequency of coughing episodes during the intervention. Secondary outcome parameters were frequency and types of complications, patient satisfaction, examiner satisfaction, and recovery time after finishing the sedation. METHODS Fifty children aged 1-17 years undergoing flexible bronchoscopy under deep sedation with propofol were randomly assigned to two groups: PR receiving propofol and remifentanil and PP receiving propofol only. Sedation depth was predefined as Comfort Score 10-13. RESULTS We found significantly less coughing episodes ([med (IQR)] PR: 0.73 (0.28-2.45)/min; PP: 1.98 (1.26-3.12)/min; p = .010) and shorter recovery time in Group PR (PR: 13.5 (8-17.5) min; PP: 21.0 (14-27) min; p = .011). Examiner's satisfaction was higher in Group PR (PR: 10 (8-10); PP: 9 (7-9); p = .012). The number of adverse events, patient satisfaction, and required propofol dose during the intervention did not differ between groups. CONCLUSION We suggest the combination of propofol with remifentanil instead of using propofol alone in pediatric procedural sedation for flexible bronchoscopy.",2021,Examiner's satisfaction was higher in group PR (PR: 10 (8-10); PP: 9 (7-9); p=0.012).,"['pediatric procedural sedation for flexible bronchoscopy', 'children', 'children undergoing flexible bronchoscopy with either', 'Methods Fifty children aged 1-17 years undergoing flexible bronchoscopy under deep sedation with']","['propofol and remifentanil and (PP) receiving propofol only', 'propofol alone', 'propofol with remifentanil', 'propofol', 'propofol alone, or a combination of propofol and remifentanil']","['Sedation depth', ""Examiner's satisfaction"", 'coughing episodes ([med (IQR', 'frequency and types of complications, patient satisfaction, examiner satisfaction, and recovery time after finishing the sedation', 'frequency of coughing episodes', 'shorter recovery time', 'number of adverse events, patient satisfaction, and required propofol dose']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1956064', 'cui_str': 'Sedation, Deep'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}]","[{'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",50.0,0.0522109,Examiner's satisfaction was higher in group PR (PR: 10 (8-10); PP: 9 (7-9); p=0.012).,"[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Tschiedel', 'Affiliation': 'Department of Pediatrics I, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Eckerland', 'Affiliation': 'Department of Pediatrics III, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Felderhoff-Mueser', 'Affiliation': 'Department of Pediatrics I, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Dohna-Schwake', 'Affiliation': 'Department of Pediatrics I, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Stehling', 'Affiliation': 'Department of Pediatrics III, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}]",Pediatric pulmonology,['10.1002/ppul.25235'] 1672,33338505,"Given a choice between self-sampling at home for HPV testing and standard of care screening at the clinic, what do African American women choose? Findings from a group randomized controlled trial.","The goals of this study were to: (1) evaluate adherence to cervical cancer screening using a patient-centered approach that provided a choice of self-sampling at home for human papillomavirus (HPV) testing or standard of care screening at the local health department ('Choice') versus only standard of care screening at the local health department ('SCS') among un/under-screened African-American women; and (2) examine whether women given a choice were more likely to choose and adhere to self-sampling for HPV testing. We conducted a group randomized trial among un/under-screened African-American women in the Mississippi Delta, with ""town"" as the unit of randomization (12 towns). Both interventions (i.e., 'Choice' versus 'SCS') were delivered by Community Health Workers (CHWs) through a door-to-door approach. A total of 335 women were enrolled in the study from 2016 to 2019. The 'Choice' arm had a significantly (p = 0.005) higher adherence to screening compared to the 'SCS' arm after adjusting for the cluster effect and other relevant behavioral variables. Participants in the 'Choice' arm were 5.62 (95% CI 1.71-18.44) times more likely to adhere to cervical cancer screening compared to participants in the 'SCS' arm. Women in the 'Choice' arm were significantly more likely to choose (76%) and adhere to self-sampling at home for HPV testing (48% adherence) compared to standard of care screening at the local health department (7.5% adherence). A theory-driven, CHW-led intervention can effectively promote cervical cancer screening among un/under-screened African-American women in a rural setting when women are provided with a choice between two screening modalities. Clinical Trials Registration: NCT03713710.",2021,The 'Choice' arm had a significantly (p = 0.005) higher adherence to screening compared to the 'SCS' arm after adjusting for the cluster effect and other relevant behavioral variables.,"['un/under-screened African-American women in the Mississippi Delta, with ""town"" as the unit of randomization (12 towns', 'A total of 335 women were enrolled in the study from 2016 to 2019']","[""cervical cancer screening using a patient-centered approach that provided a choice of self-sampling at home for human papillomavirus (HPV) testing or standard of care screening at the local health department ('Choice') versus only standard of care screening at the local health department ('SCS"", 'CHW-led intervention']",['cervical cancer screening'],"[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026221', 'cui_str': 'Mississippi'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0175699', 'cui_str': 'Saethre-Chotzen syndrome'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]",335.0,0.0744395,The 'Choice' arm had a significantly (p = 0.005) higher adherence to screening compared to the 'SCS' arm after adjusting for the cluster effect and other relevant behavioral variables.,"[{'ForeName': 'Isabel C', 'Initials': 'IC', 'LastName': 'Scarinci', 'Affiliation': 'Division of Preventive Medicine, University of Alabama at Birmingham, MT 609, 1717 11(th) Ave South, Birmingham, AL 35205, United States of America. Electronic address: scarinci@uab.edu.'}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Division of Preventive Medicine, University of Alabama at Birmingham, MT 644, 1717 11(th) Ave South, Birmingham, AL 35205, United States of America. Electronic address: yli@uabmc.edu.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Tucker', 'Affiliation': 'Mississippi State Department of Health, 570 E Woodrow Wilson Ave, Jackson, MS 39216, United States of America. Electronic address: Laura.Tucker@msdh.ms.gov.'}, {'ForeName': 'Nicole G', 'Initials': 'NG', 'LastName': 'Campos', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Harvard University, 718 Huntington Ave, Boston, MA 02138, United States of America. Electronic address: ncampos@hsph.harvard.edu.'}, {'ForeName': 'Jane J', 'Initials': 'JJ', 'LastName': 'Kim', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Center for Health Decision Science, 718 Huntington Ave, Boston, MA 02115, United States of America. Electronic address: jkim@hsph.harvard.edu.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Peral', 'Affiliation': 'Division of Preventive Medicine, University of Alabama at Birmingham, MT 101D, 1717 11(th) Ave South, Birmingham, AL 35205, United States of America. Electronic address: speral@uabmc.edu.'}, {'ForeName': 'Philip E', 'Initials': 'PE', 'LastName': 'Castle', 'Affiliation': 'Albert Einstein College of Medicine, New York, NY, United States of America; National Cancer Institute, Bethesda, MD, United States of America. Electronic address: philip.castle@nih.gov.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106358'] 1673,33017106,A Randomized Trial Comparing Antibiotics with Appendectomy for Appendicitis.,"BACKGROUND Antibiotic therapy has been proposed as an alternative to surgery for the treatment of appendicitis. METHODS We conducted a pragmatic, nonblinded, noninferiority, randomized trial comparing antibiotic therapy (10-day course) with appendectomy in patients with appendicitis at 25 U.S. centers. The primary outcome was 30-day health status, as assessed with the European Quality of Life-5 Dimensions (EQ-5D) questionnaire (scores range from 0 to 1, with higher scores indicating better health status; noninferiority margin, 0.05 points). Secondary outcomes included appendectomy in the antibiotics group and complications through 90 days; analyses were prespecified in subgroups defined according to the presence or absence of an appendicolith. RESULTS In total, 1552 adults (414 with an appendicolith) underwent randomization; 776 were assigned to receive antibiotics (47% of whom were not hospitalized for the index treatment) and 776 to undergo appendectomy (96% of whom underwent a laparoscopic procedure). Antibiotics were noninferior to appendectomy on the basis of 30-day EQ-5D scores (mean difference, 0.01 points; 95% confidence interval [CI], -0.001 to 0.03). In the antibiotics group, 29% had undergone appendectomy by 90 days, including 41% of those with an appendicolith and 25% of those without an appendicolith. Complications were more common in the antibiotics group than in the appendectomy group (8.1 vs. 3.5 per 100 participants; rate ratio, 2.28; 95% CI, 1.30 to 3.98); the higher rate in the antibiotics group could be attributed to those with an appendicolith (20.2 vs. 3.6 per 100 participants; rate ratio, 5.69; 95% CI, 2.11 to 15.38) and not to those without an appendicolith (3.7 vs. 3.5 per 100 participants; rate ratio, 1.05; 95% CI, 0.45 to 2.43). The rate of serious adverse events was 4.0 per 100 participants in the antibiotics group and 3.0 per 100 participants in the appendectomy group (rate ratio, 1.29; 95% CI, 0.67 to 2.50). CONCLUSIONS For the treatment of appendicitis, antibiotics were noninferior to appendectomy on the basis of results of a standard health-status measure. In the antibiotics group, nearly 3 in 10 participants had undergone appendectomy by 90 days. Participants with an appendicolith were at a higher risk for appendectomy and for complications than those without an appendicolith. (Funded by the Patient-Centered Outcomes Research Institute; CODA ClinicalTrials.gov number, NCT02800785.).",2020,"Complications were more common in the antibiotics group than in the appendectomy group (8.1 vs. 3.5 per 100 participants; rate ratio, 2.28; 95% CI, 1.30 to 3.98); the higher rate in the antibiotics group could be attributed to those with an appendicolith (20.2 vs. 3.6 per 100 participants; rate ratio, 5.69; 95% CI, 2.11 to 15.38) and not to those without an appendicolith (3.7 vs. 3.5 per 100 participants; rate ratio, 1.05; 95% CI, 0.45 to 2.43).","['1552 adults (414 with an appendicolith) underwent randomization; 776 were assigned to receive antibiotics (47% of whom were not hospitalized for the index treatment) and 776 to undergo appendectomy (96% of whom underwent a laparoscopic procedure', 'patients with appendicitis at 25 U.S. centers', 'Appendicitis']","['Antibiotics with Appendectomy', 'antibiotic therapy (10-day course) with appendectomy']","['European Quality of Life-5 Dimensions (EQ-5D) questionnaire (scores range', 'rate of serious adverse events', 'Complications', '30-day EQ-5D scores', '30-day health status', 'presence or absence of an appendicolith']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517771', 'cui_str': '414'}, {'cui': 'C3805175', 'cui_str': 'Appendicolith'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C3805175', 'cui_str': 'Appendicolith'}]",1552.0,0.259779,"Complications were more common in the antibiotics group than in the appendectomy group (8.1 vs. 3.5 per 100 participants; rate ratio, 2.28; 95% CI, 1.30 to 3.98); the higher rate in the antibiotics group could be attributed to those with an appendicolith (20.2 vs. 3.6 per 100 participants; rate ratio, 5.69; 95% CI, 2.11 to 15.38) and not to those without an appendicolith (3.7 vs. 3.5 per 100 participants; rate ratio, 1.05; 95% CI, 0.45 to 2.43).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Flum', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Giana H', 'Initials': 'GH', 'LastName': 'Davidson', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Monsell', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Nathan I', 'Initials': 'NI', 'LastName': 'Shapiro', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Odom', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Sabrina E', 'Initials': 'SE', 'LastName': 'Sanchez', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'F Thurston', 'Initials': 'FT', 'LastName': 'Drake', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Fischkoff', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Johnson', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Joe H', 'Initials': 'JH', 'LastName': 'Patton', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Evans', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Cuschieri', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Amber K', 'Initials': 'AK', 'LastName': 'Sabbatini', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Brett A', 'Initials': 'BA', 'LastName': 'Faine', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Dionne A', 'Initials': 'DA', 'LastName': 'Skeete', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Mike K', 'Initials': 'MK', 'LastName': 'Liang', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Vance', 'Initials': 'V', 'LastName': 'Sohn', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'McGrane', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Kutcher', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Chung', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Damien W', 'Initials': 'DW', 'LastName': 'Carter', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Ayoung-Chee', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Chiang', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Rushing', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Steinberg', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Careen S', 'Initials': 'CS', 'LastName': 'Foster', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Shaina M', 'Initials': 'SM', 'LastName': 'Schaetzel', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Thea P', 'Initials': 'TP', 'LastName': 'Price', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Mandell', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Ferrigno', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Salzberg', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'DeUgarte', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Amy H', 'Initials': 'AH', 'LastName': 'Kaji', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Moran', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Darin', 'Initials': 'D', 'LastName': 'Saltzman', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Hasan B', 'Initials': 'HB', 'LastName': 'Alam', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Pauline K', 'Initials': 'PK', 'LastName': 'Park', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Lillian S', 'Initials': 'LS', 'LastName': 'Kao', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Callie M', 'Initials': 'CM', 'LastName': 'Thompson', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Wesley H', 'Initials': 'WH', 'LastName': 'Self', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Julianna T', 'Initials': 'JT', 'LastName': 'Yu', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Wiebusch', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Winchell', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Sunday', 'Initials': 'S', 'LastName': 'Clark', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Anusha', 'Initials': 'A', 'LastName': 'Krishnadasan', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Fannon', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Danielle C', 'Initials': 'DC', 'LastName': 'Lavallee', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Bryan A', 'Initials': 'BA', 'LastName': 'Comstock', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Bizzell', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Heagerty', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Larry G', 'Initials': 'LG', 'LastName': 'Kessler', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Talan', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}]",The New England journal of medicine,['10.1056/NEJMoa2014320'] 1674,33299555,"Comparison of two lipid emulsions on interleukin-1β, interleukin-8 and fatty acid composition in infants post gastrointestinal surgery: a randomized trial.","Background: Nutritional support plays an essential role for recovery in infants who undergo gastrointestinal surgery. The current standard type of intravenous lipid emulsion (IVLE) used as parenteral nutrition is the mixture of medium-chain triglyceride (MCT) and long chain triglyceride (LCT) rich in ω-6. Studies showed that ω-6 is associated with higher level of proinflammatory cytokines, leading to increased mortality rate, morbidity rate, and postoperative recovery time. The latest generation of emulsion is a mixture of MCT, LCT, olive oil (OO), and fish oil (FO) which may optimize the ω6/ω3 ratio. This study aimed to compare the effect of MCT/LCT/OO/FO IVLE to standard IVLE on IL-1β, IL-8 and serum fatty acids in infants who had undergone gastrointestinal surgery. Methods: A single-blind, randomised controlled, pretest-posttest design study was done in twelve subjects that were classified into two groups. Group 1 received standard IVLE, group 2 received MCT/LCT/OO/FO IVLE. The type of standard and MCT/LCT/OO/FO IVLE used in this study were Lipofundin 20% and SMOFlipid 20%, respectively, both administered for three consecutive days in 1-4 gram/kilogram/day. IL-1β and IL-8 were examined using ELISA while fatty acids was analyzed using gas chromatography tandem mass spectrometry (GC-MS). Statistical analyses were performed using SPSS for Mac 23. Results: No statistical difference was found in age, gender, birth weight and diagnosis between both groups. Leukocyte was significantly lower in MCT/LCT/OO/FO group 3 days after surgery (p=0.025). CRP was lower in MCT/LCT/OO/FO group 3 days after surgery (p=0.01) and in changes within 3 days (p=0.016). There were no differences in IL-1β, IL-8 and ω-3 but ω-6 was higher in standard IVFE group on third day after surgery (p=0,048) Conclusion: MCT/LCT/OO/FO IVLE can significantly lower leukocyte, CRP and ω-6 levels and is comparable with standard IVLE on IL-1β, IL-8 and ω-3 levels in infants who had undergone gastrointestinal surgery.",2020,"There were no differences in IL-1β and IL-8 but ω-6 was higher in standard IVFE group on third day after surgery (p=0,048). ","['infants who undergo gastrointestinal surgery', 'infants who had undergone gastrointestinal surgery', 'twelve subjects that were classified into two groups', 'infants underwent gastrointestinal surgery', 'infants post gastrointestinal surgery']","['MCT/LCT/OO/FO IVLE to standard IVLE', 'MCT/LCT/OO/FO IVLE', 'standard IVFE', 'lipid emulsions', 'MCT, LCT, olive oil (OO), and fish oil (FO', 'standard IVLE', 'intravenous lipid emulsion (IVLE']","['mortality rate, morbidity rate, and postoperative recovery time', 'IL-1β, IL-8 and plasma fatty acid composition', 'interleukin-1β, interleukin-8 and fatty acid composition', 'leukocyte, CRP and ω-6 levels', 'proinflammatory cytokines', 'Leukocyte level', 'IL-1β and IL-8', 'IL-1β & IL-8 levels', 'CRP level']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0524722', 'cui_str': 'Gastrointestinal surgery'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0026687', 'cui_str': 'Mucociliary clearance'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0015667', 'cui_str': 'Lipid Emulsions, Intravenous'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",,0.258716,"There were no differences in IL-1β and IL-8 but ω-6 was higher in standard IVFE group on third day after surgery (p=0,048). ","[{'ForeName': 'Meta Herdiana', 'Initials': 'MH', 'LastName': 'Hanindita', 'Affiliation': 'Doctoral Program, Faculty of Medicine, Universitas Airlangga, Surabaya, East Java, 60286, Indonesia.'}, {'ForeName': 'Roedi', 'Initials': 'R', 'LastName': 'Irawan', 'Affiliation': 'Department of Child Health, Faculty of Medicine, Universitas Airlangga, Surabaya, East Java, 60286, Indonesia.'}, {'ForeName': 'I Dewa Gede', 'Initials': 'IDG', 'LastName': 'Ugrasena', 'Affiliation': 'Department of Child Health, Faculty of Medicine, Universitas Airlangga, Surabaya, East Java, 60286, Indonesia.'}, {'ForeName': 'I G B Adria', 'Initials': 'IGBA', 'LastName': 'Hariastawa', 'Affiliation': 'Department of Pediatric Surgery, Faculty of Medicine, Universitas Airlangga, Surabaya, East Java, 60286, Indonesia.'}]",F1000Research,['10.12688/f1000research.26269.3'] 1675,33296519,"Oxytocin in young children with Prader-Willi syndrome: Results of a randomized, double-blind, placebo-controlled, crossover trial investigating 3 months of oxytocin.","CONTEXT Prader-Willi syndrome (PWS) is characterized by hypothalamic dysfunction, hyperphagia and a typical behavioural phenotype, with characteristics of autism spectrum disorder (ASD) like stubbornness, temper tantrums and compulsivity. It has been suggested that the oxytocin system in patients with PWS is dysfunctional. In ASD, intranasal oxytocin treatment has favourable effects on behaviour. OBJECTIVE To evaluate the effects of 3 months of twice daily intranasal oxytocin (dose range 16-40 IU/day), compared to placebo, on behaviour and hyperphagia in children with PWS. DESIGN Randomized, double-blind, placebo-controlled, crossover study in the Dutch PWS Reference Center. PATIENTS Twenty-six children with PWS aged 3-11 years. MAIN OUTCOME MEASURES (Change in) behaviour and hyperphagia measured by Oxytocin Questionnaire and Dykens hyperphagia questionnaire. RESULTS In the total group, no significant effects of oxytocin on social behaviour or hyperphagia were found. However, in boys, the Oxytocin Questionnaire scores improved significantly during oxytocin treatment, compared to a deterioration during placebo (4.5 (-0.8 to 15.3) vs. -4.0 (-11.3 to 0.8), P = .025). The Dykens hyperphagia questionnaire scores remained similar during oxytocin treatment, while there was a deterioration during placebo (0.0 (-0.8 to 4.3) vs. -3.5 (-6.0 to 0.0), P = .046). Patients with a deletion had significant improvements in both questionnaire scores during oxytocin treatment, but deteriorations during placebo. Oxytocin treatment was well tolerated, and there were no serious adverse events. CONCLUSIONS Intranasal oxytocin treatment has positive effects on social and eating behaviour in 3-11 years aged boys with PWS and in children with a deletion without safety concerns. Intranasal oxytocin in children with PWS might be considered, but individual effects should be carefully evaluated and treatment discontinued if no effects are found.",2021,"CONCLUSIONS Intranasal oxytocin treatment has positive effects on social and eating behaviour in 3-11 years aged boys with PWS and in children with a deletion without safety concerns.","['children with PWS', '26 children with PWS aged 3-11 years', 'Dutch PWS Reference Center', '3-11 years aged boys with PWS and in children with a deletion without safety concerns', 'young children with Prader-Willi syndrome', 'patients with PWS']","['placebo', 'Intranasal oxytocin', 'intranasal oxytocin', 'oxytocin', 'Oxytocin']","['behavior and hyperphagia measured by Oxytocin Questionnaire and Dykens hyperphagia questionnaire', 'questionnaire scores', 'social and eating behaviour', 'Oxytocin Questionnaire scores', 'Dykens hyperphagia questionnaire scores', 'social behavior or hyperphagia']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032897', 'cui_str': 'Prader-Willi syndrome'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0008628', 'cui_str': 'Chromosomal deletion'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0020505', 'cui_str': 'Overeating'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0037397', 'cui_str': 'Social behavior'}]",26.0,0.420215,"CONCLUSIONS Intranasal oxytocin treatment has positive effects on social and eating behaviour in 3-11 years aged boys with PWS and in children with a deletion without safety concerns.","[{'ForeName': 'Layla', 'Initials': 'L', 'LastName': 'Damen', 'Affiliation': 'Dutch Growth Research Foundation, Rotterdam, the Netherlands.'}, {'ForeName': 'Lionne N', 'Initials': 'LN', 'LastName': 'Grootjen', 'Affiliation': 'Dutch Growth Research Foundation, Rotterdam, the Netherlands.'}, {'ForeName': 'Alicia F', 'Initials': 'AF', 'LastName': 'Juriaans', 'Affiliation': 'Dutch Growth Research Foundation, Rotterdam, the Netherlands.'}, {'ForeName': 'Stephany H', 'Initials': 'SH', 'LastName': 'Donze', 'Affiliation': 'Dutch Growth Research Foundation, Rotterdam, the Netherlands.'}, {'ForeName': 'T Martin', 'Initials': 'TM', 'LastName': 'Huisman', 'Affiliation': 'Department of Internal Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Jenny A', 'Initials': 'JA', 'LastName': 'Visser', 'Affiliation': 'Department of Internal Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Patric J D', 'Initials': 'PJD', 'LastName': 'Delhanty', 'Affiliation': 'Department of Internal Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Anita C S', 'Initials': 'ACS', 'LastName': 'Hokken-Koelega', 'Affiliation': 'Dutch Growth Research Foundation, Rotterdam, the Netherlands.'}]",Clinical endocrinology,['10.1111/cen.14387'] 1676,33296470,Triple P for Parents of Children with Phenylketonuria: A Nonrandomized Trial.,"OBJECTIVE Families of children with phenylketonuria (PKU) report child emotional and behavioral problems, parenting stress, and parenting difficulties, which are associated with worse health-related quality of life. This study aimed to examine acceptability and feasibility of a brief, group-based parenting program (Healthy Living Triple P) for families of children with PKU. METHODS An uncontrolled nonrandomized trial design was used. Families of children aged 2-12 years (N = 17) completed questionnaire measures assessing child behavior and impact of PKU on quality of life (primary outcomes), and parenting behavior, self-efficacy and stress, and children's behavioral and emotional adjustment (secondary outcomes). Routinely collected blood phenylalanine (Phe) levels were obtained from the treating team. Parents selected two child behaviors as targets for change. The intervention comprised two, 2-hr group sessions delivered face-to-face or online. Assessment was repeated at 4-week postintervention (T2) and 4-month follow-up (T3). RESULTS Attrition was low and parent satisfaction with the intervention (face-to-face and online) was high. All families achieved success with one or both child behavior goals, and 75% of families achieved 100% success with both behavior goals by T3; however, there was no change in health-related quality of life. There were moderate improvements in parent-reported ineffective parenting (total score, d = 0.87, 95% CI -1.01 to 2.75) and laxness (d = 0.59, 95% CI -1.27 to 2.46), but no effects on parenting stress or children's adjustment. Phe levels improved by 6month post-intervention for children with elevated preintervention levels. CONCLUSIONS Results support intervention acceptability and feasibility. A randomized controlled trial is warranted to establish intervention efficacy.",2021,"There were moderate improvements in parent-reported ineffective parenting (total score, d = 0.87, 95% CI -1.01 to 2.75) and laxness (d = 0.59, 95% CI -1.27 to 2.46), but no effects on parenting stress or children's adjustment.","['Families of children with phenylketonuria (PKU', 'Families of children aged 2-12\u2009years (N\u2009=\u200917) completed', 'Parents of Children with Phenylketonuria', 'families of children with PKU']",['group-based parenting program (Healthy Living Triple P'],"[""questionnaire measures assessing child behavior and impact of PKU on quality of life (primary outcomes), and parenting behavior, self-efficacy and stress, and children's behavioral and emotional adjustment (secondary outcomes"", 'health-related quality of life', 'parenting stress', 'blood phenylalanine (Phe) levels']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0031485', 'cui_str': 'Phenylketonuria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205174', 'cui_str': 'Triple'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0031485', 'cui_str': 'Phenylketonuria'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0557904', 'cui_str': 'Emotional adjustment'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0428204', 'cui_str': 'Phenylalanine level - finding'}]",,0.0916088,"There were moderate improvements in parent-reported ineffective parenting (total score, d = 0.87, 95% CI -1.01 to 2.75) and laxness (d = 0.59, 95% CI -1.27 to 2.46), but no effects on parenting stress or children's adjustment.","[{'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Mitchell', 'Affiliation': 'Parenting and Family Support Centre, School of Psychology, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Morawska', 'Affiliation': 'Parenting and Family Support Centre, School of Psychology, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Kirby', 'Affiliation': 'Parenting and Family Support Centre, School of Psychology, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'McGill', 'Affiliation': ""Queensland Lifespan Metabolic Medicine Service, Queensland Children's Hospital, Brisbane, Australia; School of Medicine, The University of Queensland, Brisbane, Australia.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Coman', 'Affiliation': ""Queensland Lifespan Metabolic Medicine Service, Queensland Children's Hospital, Brisbane, Australia; School of Medicine, The University of Queensland, Brisbane, Australia.""}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Inwood', 'Affiliation': ""Queensland Lifespan Metabolic Medicine Service, Queensland Children's Hospital, Brisbane, Australia; School of Nursing and Social Work, The University of Queensland, Brisbane, Australia.""}]",Journal of pediatric psychology,['10.1093/jpepsy/jsaa100'] 1677,33306103,Altered heart rate variability during sleep in mild cognitive impairment.,"STUDY OBJECTIVES Cardiovascular autonomic dysfunction, as measured by short-term diurnal heart rate variability (HRV), has been reported in older adults with mild cognitive impairment (MCI). However, it is unclear whether this impairment also exists during sleep in this group. We, therefore, compared overnight HRV during sleep in older adults with MCI and those with subjective cognitive impairment (SCI). METHODS Older adults (n = 210) underwent overnight polysomnography. Eligible participants were characterized as multi-domain MCI or SCI. The multi-domain MCI group was comprised of amnestic and non-amnestic subtypes. Power spectral analysis of HRV was conducted on the overnight electrocardiogram during non-rapid eye movement (NREM), rapid eye movement (REM), N1, N2, N3 sleep stages, and wake periods. High-frequency HRV (HF-HRV) was employed as the primary measure to estimate parasympathetic function. RESULTS The MCI group showed reduced HF-HRV during NREM sleep (p = 0.018), but not during wake or REM sleep (p > 0.05) compared to the SCI group. Participants with aMCI compared to SCI had the most pronounced reduction in HF-HRV across all NREM sleep stages-N1, N2, and N3, but not during wake or REM sleep. The naMCI sub-group did not show any significant differences in HF-HRV during any sleep stage compared to SCI. CONCLUSIONS Our study showed that amnestic MCI participants had greater reductions in HF-HRV during NREM sleep, relative to those with SCI, suggesting potential vulnerability to sleep-related parasympathetic dysfunction. HF-HRV, especially during NREM sleep, may be an early biomarker for dementia detection.",2021,"The naMCI sub-group did not show any significant differences in HF-HRV during any sleep stage compared to SCI. ","['older adults with MCI and those with subjective cognitive impairment (SCI', 'older adults with mild cognitive impairment (MCI', 'mild cognitive impairment', 'Older adults (n = 210) underwent']","['amnestic MCI', 'overnight polysomnography']","['wake or REM sleep', 'HF-HRV', 'reduced HF-HRV during NREM sleep']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C4319559', 'cui_str': '210'}]","[{'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}]","[{'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0037322', 'cui_str': 'Rapid eye movement sleep'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0234451', 'cui_str': 'Non-rapid eye movement sleep'}]",210.0,0.0375763,"The naMCI sub-group did not show any significant differences in HF-HRV during any sleep stage compared to SCI. ","[{'ForeName': 'Shawn D X', 'Initials': 'SDX', 'LastName': 'Kong', 'Affiliation': 'School of Psychology, Faculty of Science, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Camilla M', 'Initials': 'CM', 'LastName': 'Hoyos', 'Affiliation': 'School of Psychology, Faculty of Science, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Craig L', 'Initials': 'CL', 'LastName': 'Phillips', 'Affiliation': 'CogSleep, Australian National Health and Medical Research Council Centre of Research Excellence, Australia.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'McKinnon', 'Affiliation': 'School of Psychology, Faculty of Science, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Pinghsiu', 'Initials': 'P', 'LastName': 'Lin', 'Affiliation': 'School of Psychology, Faculty of Science, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Shantel L', 'Initials': 'SL', 'LastName': 'Duffy', 'Affiliation': 'Charles Perkins Centre, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Loren', 'Initials': 'L', 'LastName': 'Mowszowski', 'Affiliation': 'School of Psychology, Faculty of Science, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Haley M', 'Initials': 'HM', 'LastName': 'LaMonica', 'Affiliation': 'Healthy Brain Ageing Program, Brain and Mind Centre, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Ronald R', 'Initials': 'RR', 'LastName': 'Grunstein', 'Affiliation': 'CogSleep, Australian National Health and Medical Research Council Centre of Research Excellence, Australia.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Naismith', 'Affiliation': 'School of Psychology, Faculty of Science, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Gordon', 'Affiliation': 'CogSleep, Australian National Health and Medical Research Council Centre of Research Excellence, Australia.'}]",Sleep,['10.1093/sleep/zsaa232'] 1678,32277105,Factors influencing PCV13 specific antibody response in Danish children starting in day care.,"This study examines different factors influencing the 13-valent pneumococcal conjugate vaccine (PCV13) specific antibody response in 8-13 months old Danish children starting in day care. We present secondary findings to the ProbiComp study, which included nose swabs, buccal swabs and blood samples from the children before entering day care (baseline) and again after 6 months. Pneumococci isolated from nose swabs were identified by latex agglutination kit and Quellung reaction. Luminex-based assay was used for antibody measurements against specific anti-pneumococcal capsular IgG. Buccal gene expression was analyzed by qPCR. Statistical analyses were performed in R and included Pearson's Chi-squared test, Welch two sample t-test and linear regression models. The PCV13 antibody response was unaffected by whether the children were carriers or non-carriers of any pneumococcal serotype. Having siblings increased the risk of carrying serotype 21 before day care (p = 0.020), and having siblings increased the PCV13 antibody response at the end of study (p = 0.0135). Hepatitis B-vaccination increased the PCV13 antibody response before day care attendance (p = 0.005). The expression of IL8 and IL1B was higher in children carrying any pneumococcal serotype at baseline compared to non-carriers (p = 0.0125 and p = 0.0268 respectively).",2020,Hepatitis B-vaccination increased the PCV13 antibody response before day care attendance (p = 0.005).,"['8-13 months old Danish children starting in day care', 'Danish children starting in day care']",['13-valent pneumococcal conjugate vaccine (PCV13) specific antibody response'],"['expression of IL8 and IL1B', 'PCV13 specific antibody response', 'PCV13 antibody response']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0011017', 'cui_str': 'Day Care'}]","[{'cui': 'C3152625', 'cui_str': 'Pneumococcal 13-valent conjugate vaccine'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}]",,0.0255878,Hepatitis B-vaccination increased the PCV13 antibody response before day care attendance (p = 0.005).,"[{'ForeName': 'Sine', 'Initials': 'S', 'LastName': 'Fjeldhøj', 'Affiliation': 'Department of Bacteria, Parasites and Fungi, Statens Serum Institut, Copenhagen, Copenhagen, 2300, Denmark.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Fuglsang', 'Affiliation': 'Department of Veterinary and Animal Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Frederiksberg, 1870, Denmark.'}, {'ForeName': 'Camilla Adler', 'Initials': 'CA', 'LastName': 'Sørensen', 'Affiliation': 'Department of Bacteria, Parasites and Fungi, Statens Serum Institut, Copenhagen, Copenhagen, 2300, Denmark.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Frøkiær', 'Affiliation': 'Department of Veterinary and Animal Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Frederiksberg, 1870, Denmark.'}, {'ForeName': 'Karen Angeliki', 'Initials': 'KA', 'LastName': 'Krogfelt', 'Affiliation': 'Department of Bacteria, Parasites and Fungi, Statens Serum Institut, Copenhagen, Copenhagen, 2300, Denmark.'}, {'ForeName': 'Rikke Pilmann', 'Initials': 'RP', 'LastName': 'Laursen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Frederiksberg, 1958, Denmark.'}, {'ForeName': 'Hans-Christian', 'Initials': 'HC', 'LastName': 'Slotved', 'Affiliation': 'Department of Bacteria, Parasites and Fungi, Statens Serum Institut, Copenhagen, Copenhagen, 2300, Denmark. hcs@ssi.dk.'}]",Scientific reports,['10.1038/s41598-020-63080-x'] 1679,33309516,An Evaluation of the Structural Validity of the Work Limitation Questionnaire Using the Rasch Model.,"OBJECTIVE To investigate the targeting, scaling, and structural validity of the Work Limitation Questionnaire (WLQ) using Rasch analysis. DESIGN Secondary data analysis. SETTING Tertiary care hospital. PARTICIPANTS The data were sourced from an upper limb specialty clinic of injured workers using the convenience sampling method and from a national randomized controlled trial investigating 2 surgical options for rotator cuff repair by formal, randomized selection (N=315). INTERVENTIONS Not applicable. MAIN OUTCOME MEASURES Work Limitation Questionnaire 25-item version (WLQ-25). The WLQ contains 25 items measuring a client's ability to perform specific job demands on a 5-point ordinal response scale ranging from 0 (difficulty none of the time) to 4 (difficulty all the time). The average of all 25 items is used as the total score, ranging from 0 to 4, where higher index scores indicate greater difficulty performing daily work. Subscales were used to assess time management, physical demands (PD), mental-interpersonal demands, and output demands. RESULTS The Rasch analyses performed on the dataset included the test of fit of residuals, ordering of item thresholds, Person separation index, differential item functioning (DIF), dependency, and unidimensionality. The partial credit model was selected for the current Rasch analysis because the likelihood ratio test was significant at both the overall questionnaire and the subscale level (P<.001). The WLQ-25 did not fit with the Rasch model (χ 2 =1715.58; df=125; P<.001) and most of the thresholds were disordered. A series of steps were undertaken to improve the fit statistic, including item reduction (6 items) and response merging (9 items). DIF was absent in the revised scale based on sex, age, full- or part-time employment, and type of employment. Only 3 revised subscales, namely the PD, mental demands, and interpersonal demands subscales, demonstrated acceptable fit to the Rasch model. CONCLUSIONS The WLQ-25 demonstrated substantial misfit from the Rasch model, which could not be fully mediated. The revised PD, mental demands, and interpersonal demands subscales could be used to assess these constructs.",2021,"The WLQ-25 did not fit with the Rasch model (χ 2 = 1715.58, df = 125, p < 0.001) and most of the thresholds were disordered.","['The data were sourced from an upper limb specialty clinic of injured workers by convenience sampling method and from a national randomized control trial (RCT) investigating two surgical options for rotator cuff repair by formal, randomized selection']",[],"['Work Limitation Questionnaire 25-item version (WLQ-25', 'Person separation index, differential item functioning (DIF), dependency, and unidimensionality', 'Physical Demands, Mental Demands and Interpersonal Demands subscales', 'Time Management (TM), the Physical Demands (PD), the Mental-Interpersonal Demands (MI), and the Output Demands (OD']","[{'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0449370', 'cui_str': 'Method of sampling'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0282440', 'cui_str': 'Randomized Controlled Trials as Topic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}]",[],"[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036679', 'cui_str': 'Separation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0206209', 'cui_str': 'Time Management'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}]",2.0,0.0226216,"The WLQ-25 did not fit with the Rasch model (χ 2 = 1715.58, df = 125, p < 0.001) and most of the thresholds were disordered.","[{'ForeName': 'Ze', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': ""School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada; Roth McFarlane Hand and Upper Limb Centre, St. Joseph's Hospital, London, Ontario, Canada. Electronic address: luze66269271@gmail.com.""}, {'ForeName': 'Joy C', 'Initials': 'JC', 'LastName': 'MacDermid', 'Affiliation': ""School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada; Roth McFarlane Hand and Upper Limb Centre, St. Joseph's Hospital, London, Ontario, Canada; School of Physical Therapy, Western University, London, Ontario, Canada.""}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Packham', 'Affiliation': 'School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'Bryant', 'Affiliation': 'School of Physical Therapy, Western University, London, Ontario, Canada; Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario Canada.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Faber', 'Affiliation': ""Roth McFarlane Hand and Upper Limb Centre, St. Joseph's Hospital, London, Ontario, Canada; Department of Surgery, Western University, London, Ontario, Canada.""}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.11.009'] 1680,33307932,Framing a Consent Form to Improve Consent Understanding and Determine How This Affects Willingness to Participate in HIV Cure Research: An Experimental Survey Study.,"HIV cure research carries serious risks and negligible benefits. We investigated how participants understand these risks and what influences their willingness to participate. Through internet-based and in-person convenience sampling, 86 HIV+ participants completed an experimental survey. Participants were randomized to read a standard consent form describing a hypothetical HIV cure study or one adapted using Fuzzy Trace Theory-a decision-making model to facilitate complex information processing. We measured consent understanding and cognitive (e.g., safe/harmful) and affective (e.g., concerning, satisfying) evaluations of HIV cure research. Participants who read the adapted consent form had improved consent understanding, but only positive affective evaluations were associated with a willingness to participate. Consent processes can use decision-making theories to facilitate comprehension of study information.",2021,"Participants who read the adapted consent form had improved consent understanding, but only positive affective evaluations were associated with a willingness to participate.","['86 HIV+ participants completed an experimental survey', 'HIV Cure Research']",['Fuzzy Trace Theory-a decision-making model to facilitate complex information processing'],[],"[{'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]","[{'cui': 'C0541974', 'cui_str': 'Fuzzy head'}, {'cui': 'C0442822', 'cui_str': 'Trace'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}]",[],86.0,0.0354497,"Participants who read the adapted consent form had improved consent understanding, but only positive affective evaluations were associated with a willingness to participate.","[{'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Sauceda', 'Affiliation': '8785University of California San Francisco, USA.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Dubé', 'Affiliation': '2331University of North Carolina Chapel Hill, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Brown', 'Affiliation': '8790University of California Riverside, USA.'}, {'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Pérez', 'Affiliation': '8785University of California San Francisco, USA.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Rivas', 'Affiliation': '8785University of California San Francisco, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Evans', 'Affiliation': '455669Delaney AIDS Research Enterprise Martin Delaney Collaboratory Community Advisory Board, San Francisco, CA, USA.'}, {'ForeName': 'Celia B', 'Initials': 'CB', 'LastName': 'Fisher', 'Affiliation': '5923Fordham University, Bronx, NY, USA.'}]",Journal of empirical research on human research ethics : JERHRE,['10.1177/1556264620981205'] 1681,33314313,"Effect of Low-Intensity Vibration on Bone Strength, Microstructure, and Adiposity in Pre-Osteoporotic Postmenopausal Women: A Randomized Placebo-Controlled Trial.","There has been evidence that cyclical mechanical stimulation may be osteogenic, thus providing opportunities for nonpharmacological treatment of degenerative bone disease. Here, we applied this technology to a cohort of postmenopausal women with varying bone mineral density (BMD) T-scores at the total hip (-0.524 ± 0.843) and spine (-0.795 ± 1.03) to examine the response to intervention after 1 year of daily treatment with 10 minutes of vibration therapy in a randomized double-blinded trial. The device operates either in an active mode (30 Hz and 0.3 g) or placebo. Primary endpoints were changes in bone stiffness at the distal tibia and marrow adiposity of the vertebrae, based on 3 Tesla high-resolution MRI and spectroscopic imaging, respectively. Secondary outcome variables included distal tibial trabecular microstructural parameters and vertebral deformity determined by MRI, volumetric and areal bone densities derived using peripheral quantitative computed tomography (pQCT) of the tibia, and dual-energy X-ray absorptiometry (DXA)-based BMD of the hip and spine. Device adherence was 83% in the active group (n = 42) and 86% in the placebo group (n = 38) and did not differ between groups (p = .7). The mean 12-month changes in tibial stiffness in the treatment group and placebo group were +1.31 ± 6.05% and -2.55 ± 3.90%, respectively (group difference 3.86%, p = .0096). In the active group, marrow fat fraction significantly decreased after 12 months of intervention (p = .0003), whereas no significant change was observed in the placebo group (p = .7; group difference -1.59%, p = .029). Mean differences of the changes in trabecular bone volume fraction (p = .048) and erosion index (p = .044) were also significant, as was pQCT-derived trabecular volumetric BMD (vBMD; p = .016) at the tibia. The data are commensurate with the hypothesis that vibration therapy is protective against loss in mechanical strength and, further, that the intervention minimizes the shift from the osteoblastic to the adipocytic lineage of mesenchymal stem cells. © 2020 American Society for Bone and Mineral Research (ASBMR).",2021,"In the active group, marrow fat fraction significantly decreased after 12 months of intervention (p = 0.0003), while no significant change was observed in the placebo group (p = 0.7; group difference - 1.59%, p = 0.029).","['postmenopausal women with varying bone mineral density (BMD) T-scores at the total hip (-0.524\u2009±\u20090.843) and spine (-0.795\u2009±\u20091.03', 'Pre-Osteoporotic Postmenopausal', 'Women']","['Placebo', 'Low Intensity Vibration', 'placebo', 'vibration therapy']","['trabecular bone volume fraction', 'erosion index', 'Bone Strength, Microstructure, and Adiposity', 'Device adherence', 'distal tibial trabecular microstructural parameters and vertebral deformity determined by MRI, volumetric and areal bone densities derived using peripheral quantitative computed tomography (pQCT) of the tibia, and dual-energy X-ray absorptiometry (DXA)-based BMD of the hip and spine', 'mean 12-month changes in tibial stiffness', 'marrow fat fraction', 'changes in bone stiffness at the distal tibia and marrow adiposity of the vertebrae, based on 3 Tesla high-resolution MRI and spectroscopic imaging, respectively']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0222660', 'cui_str': 'Trabecular substance of bone'}, {'cui': 'C0560268', 'cui_str': 'Volume fraction'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4708472', 'cui_str': 'Device adherence'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0412669', 'cui_str': 'Computerized tomography, bone density study'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0229602', 'cui_str': 'Structure of bone marrow fatty tissue'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0588200', 'cui_str': 'Bone structure of distal tibia'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]",,0.372592,"In the active group, marrow fat fraction significantly decreased after 12 months of intervention (p = 0.0003), while no significant change was observed in the placebo group (p = 0.7; group difference - 1.59%, p = 0.029).","[{'ForeName': 'Chamith S', 'Initials': 'CS', 'LastName': 'Rajapakse', 'Affiliation': 'Department of Radiology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Alyssa J', 'Initials': 'AJ', 'LastName': 'Johncola', 'Affiliation': 'Department of Radiology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Alexandra S', 'Initials': 'AS', 'LastName': 'Batzdorf', 'Affiliation': 'Department of Radiology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Brandon C', 'Initials': 'BC', 'LastName': 'Jones', 'Affiliation': 'Department of Radiology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Al Mukaddam', 'Affiliation': 'Department of Orthopaedic Surgery, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Sexton', 'Affiliation': 'Department of Radiology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Shults', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Mary B', 'Initials': 'MB', 'LastName': 'Leonard', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia, PA, USA.""}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Snyder', 'Affiliation': 'Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Felix W', 'Initials': 'FW', 'LastName': 'Wehrli', 'Affiliation': 'Department of Radiology, University of Pennsylvania, Philadelphia, PA, USA.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.4229'] 1682,33341530,Identifying message content to reduce vaping: Results from online message testing trials in young adult tobacco users.,"INTRODUCTION Young adults' e-cigarette use is associated with perceptions that e-cigarettes are less harmful or addictive than cigarettes, socially acceptable, and appealing. This study developed and tested vaping educational messages addressing these factors: 1) Harm Perceptions, 2) Addictiveness, 3) Social Use, and 4) Flavors. METHODS Two message trials were conducted in U.S. Amazon Mechanical Turk workers aged 18-24 using a 2 (content: addiction, harm) × 3 (theme: alone, + flavors, + social) design with multiple messages in each of the six categories. Participants were assigned to view a random subset of messages and report on likeability and perceived message effectiveness (PME). Phase 1 (n = 200) tested 33 messages and 32 images. Phase 2 (n = 769) tested combinations of Phase 1's 24 most effective messages with 6 images rated most likeable or effective. Linear mixed effects models assessed the effect of content, theme, image, and their interactions on message response. RESULTS In both trials, most participants were past 30-day tobacco users. Harm content messages produced higher PME ratings than addiction content messages, and flavor theme messages were correlated with higher likeability scores than ""content alone"" theme messages. In Phase 2, flavor and social message themes decreased the PME of harm messages. There was no effect of images on either outcome controlling for the independent or interaction effects of content, theme, and image. CONCLUSIONS Messages conveying the harms of vaping may be best for reducing vaping in young adult tobacco users; flavor and social themes may diminish their effectiveness.",2021,"Harm content messages produced higher PME ratings than addiction content messages, and flavor theme messages were correlated with higher likeability scores than ""content alone"" theme messages.","['Two message trials were conducted in U.S. Amazon Mechanical Turk workers aged 18-24 using a 2 (content: addiction, harm)\xa0×\xa03', 'young adult tobacco users']",[],"['PME ratings', 'likeability scores', 'PME of harm messages']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0337911', 'cui_str': 'Turks'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C3853727', 'cui_str': 'Tobacco user'}]",[],"[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.111863,"Harm content messages produced higher PME ratings than addiction content messages, and flavor theme messages were correlated with higher likeability scores than ""content alone"" theme messages.","[{'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Villanti', 'Affiliation': 'Vermont Center on Behavior and Health, Department of Psychiatry, University of Vermont, USA. Electronic address: andrea.villanti@uvm.edu.'}, {'ForeName': 'S Elisha', 'Initials': 'SE', 'LastName': 'LePine', 'Affiliation': 'Vermont Center on Behavior and Health, Department of Psychiatry, University of Vermont, USA.'}, {'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'West', 'Affiliation': 'Vermont Center on Behavior and Health, Department of Psychiatry, University of Vermont, USA.'}, {'ForeName': 'Tess Boley', 'Initials': 'TB', 'LastName': 'Cruz', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, USA.'}, {'ForeName': 'Elise M', 'Initials': 'EM', 'LastName': 'Stevens', 'Affiliation': 'Harvard TH Chan School of Public Health and Dana-Farber Cancer Institute, Harvard University, USA.'}, {'ForeName': 'Haley J', 'Initials': 'HJ', 'LastName': 'Tetreault', 'Affiliation': 'Vermont Center on Behavior and Health, Department of Psychiatry, University of Vermont, USA.'}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'Unger', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, USA.'}, {'ForeName': 'Olivia A', 'Initials': 'OA', 'LastName': 'Wackowski', 'Affiliation': 'Center for Tobacco Studies, School of Public Health, Rutgers, the State University, USA.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Mays', 'Affiliation': 'Department of Internal Medicine, Wexner Medical Center, Center for Tobacco Research, The Ohio State University Comprehensive Cancer Center, USA.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106778'] 1683,31800479,A Comparison of Training Modality and Total Genotype Scores to Enhance Sport-Specific Biomotor Abilities in Under 19 Male Soccer Players.,"ABSTRACT Suraci, BR, Quigley, C, Thelwell, RC, and Milligan, GS. A comparison of training modality and total genotype scores to enhance sport-specific biomotor abilities in under 19 male soccer players. J Strength Cond Res 35(1): 154-161, 2021-Soccer-specific training (SST) and small-sided games (SSGs) have been shown to develop physical proficiency in soccer. Research on genetics and epigenetics in the prescription of training is limited. The aims of this study were to compare the impact of 3 different SST/SSG methods and investigate if a total genotype score (TGS) influences training response. Subjects (n = 30 male soccer players, mean ± SD; age 17.2 ± 0.9 years, stature = 172.6 ± 6.2 cm; body mass = 71.7 ± 10.1 kg) were stratified into a ""power"" (PG) or ""endurance"" (EG) gene profile group, where a 15 single nucleotide polymorphism panel was used to produce an algorithmically weighted TGS. Training 1 (T1-SSGs only), training 2 (T2-SSGs/SST), and training 3 (T3-SST only) were completed (in that respective order), lasting 8 weeks each, interspersed by 4-week washouts. Acceleration (10-m sprint) was improved by T2 only (1.84 ± 0.09 seconds vs. 1.73 ± 0.05 seconds; Effect Size [ES] = 1.59, p < 0.001). Speed (30-m sprint) was improved by T2 (4.46 ± 0.22 seconds vs. 4.30 ± 0.19 seconds; ES = 0.81, p < 0.001) and T3 (4.48 ± 0.22 seconds vs. 4.35 ± 0.21 seconds; ES = 0.58, p < 0.001). Agility (T-test) was improved by T1 (10.14 ± 0.40 seconds vs. 9.84 ± 0.42 seconds; ES = 0.73, p < 0.05) and T3 (9.93 ± 0.38 seconds vs. 9.66 ± 0.45 seconds; ES = 0.66, p < 0.001). Endurance (Yo-Yo level 1) was improved by T1 (1,682.22 ± 497.23 m vs. 2,028.89 ± 604.74 m; ES = 0.63, p < 0.05), T2 (1,904.35 ± 526.77 m vs. 2,299.13 ± 606.97 m; ES = 0.69, p < 0.001), and T3 (1,851.76 ± 490.46 m vs. 2,024.35 ± 588.13 m; ES = 0.35, p < 0.05). Power (countermovement jump) was improved by T3 only (36.01 ± 5.73 cm vs. 37.14 ± 5.62 cm; ES = 0.20, p < 0.05). There were no differences in T1, T2, and T3 combined when comparing PG and EG. The PG reported significantly (χ2(20) = 4.42, p = 0.035, ES = 0.48) better training responses to T3 for power than the EG. These results demonstrate the efficacy of SSGs and SSTs in developing biomotor abilities. Although these results refute talent identification through the use of a TGS, there may be use in aligning the training method to TGS to develop power-based qualities in soccer.",2021,"The PG reported significantly (χ2(20) = 4.42, p = 0.035, ES = 0.48) better training responses to T3 for power than the EG.","['Subjects (n = 30 male soccer players, mean ± SD; age 17.2 ± 0.9 years, stature = 172.6 ± 6.2 cm; body mass = 71.7 ± 10.1 kg', 'Under 19 Male Soccer Players', 'under 19 male soccer players']","['Training 1 (T1-SSGs only), training 2 (T2-SSGs/SST), and training 3 (T3-SST only', 'power"" (PG) or ""endurance"" (EG) gene profile group', 'training modality and total genotype scores to enhance sport-specific biomotor abilities', 'Training Modality and Total Genotype Scores to Enhance Sport-Specific Biomotor Abilities', '2021-Soccer-specific training (SST) and small-sided games (SSGs']","['Acceleration (10-m sprint', 'total genotype score (TGS) influences training response']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]","[{'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]",30.0,0.0730968,"The PG reported significantly (χ2(20) = 4.42, p = 0.035, ES = 0.48) better training responses to T3 for power than the EG.","[{'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Suraci', 'Affiliation': 'The Football Gene, London, United Kingdom; and.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Quigley', 'Affiliation': 'The Football Gene, London, United Kingdom; and.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Thelwell', 'Affiliation': 'Department of Sport and Exercise Science, University of Portsmouth, Portsmouth, United Kingdom.'}, {'ForeName': 'Gemma S', 'Initials': 'GS', 'LastName': 'Milligan', 'Affiliation': 'Department of Sport and Exercise Science, University of Portsmouth, Portsmouth, United Kingdom.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003299'] 1684,33164570,Association of Baseline and Longitudinal Changes in Body Composition Measures With Risk of Heart Failure and Myocardial Infarction in Type 2 Diabetes: Findings From the Look AHEAD Trial.,"BACKGROUND Intentional weight loss is associated with lower risk of heart failure (HF) and atherosclerotic cardiovascular disease among patients with type 2 diabetes. However, the contribution of baseline measures and longitudinal changes in fat mass (FM), lean mass (LM), and waist circumference (WC) to the risk of HF and myocardial infarction (MI) in type 2 diabetes is not well established. METHODS Adults from the Look AHEAD trial (Action for Health in Diabetes) without prevalent HF were included. FM and LM were predicted using validated equations and compared with dual-energy x-ray absorptiometry measurements in a subgroup. Adjusted Cox models were used to evaluate the associations of baseline and longitudinal changes in FM, LM, and WC over 1- and 4-year follow-up with risk of overall HF, HF with preserved ejection fraction (EF; EF ≥50%), HF with reduced EF (EF <50%), and MI. RESULTS Among 5103 participants, there were 257 incident HF events over 12.4 years of follow-up. Predicted and measured FM/LM were highly correlated ( R 2 =0.87-0.90; n=1369). FM and LM decreased over 4-year follow-up with greater declines in the intensive lifestyle intervention arm. In adjusted analysis, baseline body composition measures were not significantly associated with HF risk. Decline in FM and WC, but not LM, over 1 year were each significantly associated with lower risk of overall HF (adjusted hazard ratio per 10% decrease in FM, 0.80 [95% CI, 0.68-0.95]; adjusted hazard ratio per 10% decrease in WC, 0.77 [95% CI, 0.62-0.95]). Decline in FM was significantly associated with lower risk of both HF subtypes. In contrast, decline in WC was significantly associated with lower risk of HF with preserved EF but not HF with reduced EF. Similar patterns of association were observed for 4-year changes in body composition and HF risk. Longitudinal changes in body composition were not significantly associated with risk of MI. CONCLUSIONS In adults with type 2 diabetes, a lifestyle intervention is associated with significant loss of FM and LM. Declines in FM and WC, but not LM, were each significantly associated with lower risk of HF but not MI. Furthermore, decline in WC was significantly associated with lower risk of HF with preserved EF but not HF with reduced EF. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00017953.",2020,"Decline in FM and WC, but not LM, over 1 year were each significantly associated with lower risk of overall HF (adjusted hazard ratio per 10% decrease in FM, 0.80 [95% CI, 0.68-0.95]; adjusted hazard ratio per 10% decrease in WC, 0.77 [95% CI, 0.62-0.95]).","['Adults from the Look AHEAD trial (Action for Health in Diabetes) without prevalent HF were included', 'adults with type 2 diabetes', '5103 participants, there were 257 incident HF events over 12.4 years of follow-up', 'Type 2 Diabetes', 'patients with type 2 diabetes']",[],"['body composition', 'Body Composition Measures', 'FM and LM', 'FM, LM, and WC', 'fat mass (FM), lean mass (LM), and waist circumference (WC) to the risk of HF and myocardial infarction (MI', 'loss of FM and LM', 'Decline in FM and WC', 'FM/LM', 'Decline in FM', 'lower risk of overall HF']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C4517543', 'cui_str': '12.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1285593', 'cui_str': 'Body composition measure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",5103.0,0.124659,"Decline in FM and WC, but not LM, over 1 year were each significantly associated with lower risk of overall HF (adjusted hazard ratio per 10% decrease in FM, 0.80 [95% CI, 0.68-0.95]; adjusted hazard ratio per 10% decrease in WC, 0.77 [95% CI, 0.62-0.95]).","[{'ForeName': 'Kershaw V', 'Initials': 'KV', 'LastName': 'Patel', 'Affiliation': 'Department of Internal Medicine, Division of Cardiology, University of Texas Southwestern Medical Center, Dallas (K.V.P., J.D.B., A.P.).'}, {'ForeName': 'Judy L', 'Initials': 'JL', 'LastName': 'Bahnson', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC (J.L.B., S.A.G.).'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Gaussoin', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC (J.L.B., S.A.G.).'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis (K.C.J.).'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': 'New York Obesity Research Center, Columbia University Medical Center (X.P.).'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'White', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge (U.W.).'}, {'ForeName': 'KayLoni L', 'Initials': 'KL', 'LastName': 'Olson', 'Affiliation': 'Department of Psychiatry and Human Behavior, Brown Medical School, Providence, RI (K.L.O.).'}, {'ForeName': 'Alain G', 'Initials': 'AG', 'LastName': 'Bertoni', 'Affiliation': 'Department of Epidemiology and Prevention, Wake Forest School of Medicine, Winston-Salem, NC (A.G.B.).'}, {'ForeName': 'Dalane W', 'Initials': 'DW', 'LastName': 'Kitzman', 'Affiliation': 'Department of Internal Medicine, Sections on Cardiovascular Medicine and Geriatrics, Wake Forest School of Medicine, Winston-Salem, NC (D.W.K.).'}, {'ForeName': 'Jarett D', 'Initials': 'JD', 'LastName': 'Berry', 'Affiliation': 'Department of Internal Medicine, Division of Cardiology, University of Texas Southwestern Medical Center, Dallas (K.V.P., J.D.B., A.P.).'}, {'ForeName': 'Ambarish', 'Initials': 'A', 'LastName': 'Pandey', 'Affiliation': 'Department of Internal Medicine, Division of Cardiology, University of Texas Southwestern Medical Center, Dallas (K.V.P., J.D.B., A.P.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.120.050941'] 1685,33300592,How Prescribed Music and Preferred Music Influence Sleep Quality in University Students.,"OBJECTIVE The purpose of this study was to investigate the effect of listening to music on sleep quality in university students and to explore the influence of preferred music on this effect. METHODS University students identified by the Pittsburgh Sleep Quality Index (PSQI) as 'poor' sleepers (global score > 5) were assigned to three groups (a prescribed music group, preferred music group, and no-music group). During the period of intervention, the prescribed music group and preferred music group listened to their assigned type of music at home every day at bedtime. RESULTS Global PSQI scores after the intervention were significantly lower in the prescribed music group and preferred music group, but there was no significant reduction in the no-music group. Between the designated sedative music group and the each subject's preferred music group, both the PSQI score showed significant differences in several items, but variations were found in the results. CONCLUSIONS This study confirms that listening to music improves sleep quality, even among university students in Japan. Sleep quality was improved in both prescribed and preferred music groups, although the groups gave different responses to specific PSQI components, which suggests that sleep is potentially affected by music type.",2020,"Sleep quality was improved in both prescribed and preferred music groups, although the groups gave different responses to specific PSQI components, which suggests that sleep is potentially affected by music type.","[""University students identified by the Pittsburgh Sleep Quality Index (PSQI) as 'poor' sleepers (global score > 5"", 'university students in Japan', 'university students', 'University Students']","['listening to music', 'music group, preferred music group, and no-music group', 'music group and preferred music group listened to their assigned type of music at home every day at bedtime']","['sleep quality', 'Sleep quality', 'Global PSQI scores']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}]",,0.0424112,"Sleep quality was improved in both prescribed and preferred music groups, although the groups gave different responses to specific PSQI components, which suggests that sleep is potentially affected by music type.","[{'ForeName': 'Ami', 'Initials': 'A', 'LastName': 'Yamasato', 'Affiliation': 'Graduate School of Medicine, Tokai University, 143 Shimokasuya, Isehara, Kanagawa 259-1193, Japan. ami.yamasato@gmail.com.'}, {'ForeName': 'Mayu', 'Initials': 'M', 'LastName': 'Kondo', 'Affiliation': ''}, {'ForeName': 'Shunya', 'Initials': 'S', 'LastName': 'Hoshino', 'Affiliation': ''}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Kikuchi', 'Affiliation': ''}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Ikeuchi', 'Affiliation': ''}, {'ForeName': 'Kiyoyuki', 'Initials': 'K', 'LastName': 'Yamazaki', 'Affiliation': ''}, {'ForeName': 'Shigeki', 'Initials': 'S', 'LastName': 'Okino', 'Affiliation': ''}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': ''}]",The Tokai journal of experimental and clinical medicine,[] 1686,33301569,Modulation of beta bursts in subthalamic sensorimotor circuits predicts improvement in bradykinesia.,"No biomarker of Parkinson's disease exists that allows clinicians to adjust chronic therapy, either medication or deep brain stimulation, with real-time feedback. Consequently, clinicians rely on time-intensive, empirical, and subjective clinical assessments of motor behaviour and adverse events to adjust therapies. Accumulating evidence suggests that hypokinetic aspects of Parkinson's disease and their improvement with therapy are related to pathological neural activity in the beta band (beta oscillopathy) in the subthalamic nucleus. Additionally, effectiveness of deep brain stimulation may depend on modulation of the dorsolateral sensorimotor region of the subthalamic nucleus, which is the primary site of this beta oscillopathy. Despite the feasibility of utilizing this information to provide integrated, biomarker-driven precise deep brain stimulation, these measures have not been brought together in awake freely moving individuals. We sought to directly test whether stimulation-related improvements in bradykinesia were contingent on reduction of beta power and burst durations, and/or the volume of the sensorimotor subthalamic nucleus that was modulated. We recorded synchronized local field potentials and kinematic data in 16 subthalamic nuclei of individuals with Parkinson's disease chronically implanted with neurostimulators during a repetitive wrist-flexion extension task, while administering randomized different intensities of high frequency stimulation. Increased intensities of deep brain stimulation improved movement velocity and were associated with an intensity-dependent reduction in beta power and mean burst duration, measured during movement. The degree of reduction in this beta oscillopathy was associated with the improvement in movement velocity. Moreover, the reduction in beta power and beta burst durations was dependent on the theoretical degree of tissue modulated in the sensorimotor region of the subthalamic nucleus. Finally, the degree of attenuation of both beta power and beta burst durations, together with the degree of overlap of stimulation with the sensorimotor subthalamic nucleus significantly explained the stimulation-related improvement in movement velocity. The above results provide direct evidence that subthalamic nucleus deep brain stimulation-related improvements in bradykinesia are related to the reduction in beta oscillopathy within the sensorimotor region. With the advent of sensing neurostimulators, this beta oscillopathy combined with lead location could be used as a marker for real-time feedback to adjust clinical settings or to drive closed-loop deep brain stimulation in freely moving individuals with Parkinson's disease.",2021,"Increased intensities of deep brain stimulation improved movement velocity and were associated with an intensity-dependent reduction in beta power and mean burst duration, measured during movement.","[""16 subthalamic nuclei of individuals with Parkinson's disease chronically implanted with neurostimulators during a repetitive wrist-flexion extension task""]",['synchronized local field potentials and kinematic data'],"['beta power and beta burst durations', 'degree of attenuation of both beta power and beta burst durations', 'bradykinesia']","[{'cui': 'C0152355', 'cui_str': 'Nucleus of Luys'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0582124', 'cui_str': 'Neurostimulator'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0444509', 'cui_str': 'Flexion/extension'}]","[{'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}]","[{'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0233565', 'cui_str': 'Bradykinesia'}]",,0.0444978,"Increased intensities of deep brain stimulation improved movement velocity and were associated with an intensity-dependent reduction in beta power and mean burst duration, measured during movement.","[{'ForeName': 'Yasmine M', 'Initials': 'YM', 'LastName': 'Kehnemouyi', 'Affiliation': 'Stanford University School of Medicine, Department of Neurology and Neurological Sciences, Stanford, CA, USA.'}, {'ForeName': 'Kevin B', 'Initials': 'KB', 'LastName': 'Wilkins', 'Affiliation': 'Stanford University School of Medicine, Department of Neurology and Neurological Sciences, Stanford, CA, USA.'}, {'ForeName': 'Chioma M', 'Initials': 'CM', 'LastName': 'Anidi', 'Affiliation': 'Stanford University School of Medicine, Department of Neurology and Neurological Sciences, Stanford, CA, USA.'}, {'ForeName': 'Ross W', 'Initials': 'RW', 'LastName': 'Anderson', 'Affiliation': 'Stanford University School of Medicine, Department of Neurology and Neurological Sciences, Stanford, CA, USA.'}, {'ForeName': 'Muhammad Furqan', 'Initials': 'MF', 'LastName': 'Afzal', 'Affiliation': 'Stanford University School of Medicine, Department of Neurology and Neurological Sciences, Stanford, CA, USA.'}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Bronte-Stewart', 'Affiliation': 'Stanford University School of Medicine, Department of Neurology and Neurological Sciences, Stanford, CA, USA.'}]",Brain : a journal of neurology,['10.1093/brain/awaa394'] 1687,33306586,Whole Egg Vs. Egg White Ingestion During 12 weeks of Resistance Training in Trained Young Males: A Randomized Controlled Trial.,"ABSTRACT Bagheri, R, Moghadam, BH, Ashtary-Larky, D, Forbes, SC, Candow, DG, Galpin, AJ, Eskandari, M, Kreider, RB, and Wong, A. Whole egg vs. egg white ingestion during 12 weeks of resistance training in trained young males: a randomized controlled trial. J Strength Cond Res 35(2): 411-419, 2021-The primary purpose was to compare the effects of whole egg ingestion and egg white ingestion during 12 weeks of resistance training (RT) on muscle cross-sectional area, body composition, muscular strength, and anaerobic power in resistance-trained young males. A secondary purpose was to examine systemic hormonal responses. Thirty resistance-trained young males were randomly assigned to one of 2 groups: Whole eggs + RT (WER; n = 15) or egg whites + RT (ERT; n = 15). Whole eggs + RT ingested 3 whole eggs immediately following RT, whereas ERT ingested an isonitrogenous quantity consisting of 6 egg whites immediately following RT. Before and after 12 weeks of whole-body undulating periodized RT (3 sessions per week), knee extensor muscle mass and cross-sectional area (computed tomography), lean body mass and body fat percentage (bioelectrical impedance), muscular strength (knee extension, handgrip strength), Wingate (cycle ergometer), and serum concentrations of hormones were assessed. There was a significant group × time interaction for body fat percentage, serum testosterone, knee extension, and handgrip strength with greater improvements observed in WER. There was a significant main effect of time (p < 0.05) for knee extensor muscle mass, cross-sectional area, lean body mass, anaerobic power, and all other blood hormones. There was a trend (p = 0.06) in the WER group for having a greater change in lean body mass compared with that of ERT. Postexercise whole egg ingestion increases knee extension and handgrip strength, testosterone, and reduces body fat percentage compared with postexercise egg white ingestion, despite no group differences in muscle mass, in resistance-trained young males. Whole eggs consumption may be preferable during RT programs geared toward the improvement of muscular strength and body fat percentage.",2021,"There was a significant group × time interaction for body fat percentage, serum testosterone, knee extension, and handgrip strength with greater improvements observed in WER.","['Trained Young Males', 'Thirty resistance-trained young males', 'trained young males']","['Egg White Ingestion', 'whole egg ingestion and egg white ingestion during 12 weeks of resistance training (RT', 'J Strength Cond Res XX(X', 'Whole eggs + RT (WER; n = 15) or egg whites + RT (ERT', 'Postexercise whole egg ingestion', 'Resistance Training', 'resistance training']","['knee extensor muscle mass, cross-sectional area, lean body mass, anaerobic power, and all other blood hormones', 'systemic hormonal responses', 'muscular strength and body fat percentage', 'WER', 'knee extensor muscle mass and cross-sectional area (computed tomography), lean body mass and body fat percentage (bioelectrical impedance), muscular strength (knee extension, handgrip strength), Wingate (cycle ergometer), and serum concentrations of hormones', 'time interaction for body fat percentage, serum testosterone, knee extension, and handgrip strength', 'muscle cross-sectional area, body composition, muscular strength, and anaerobic power in resistance', 'lean body mass', 'Bagheri, R, Moghadam, BH, Ashtary-Larky, D, Forbes, SC, Candow, DG, Galpin, AJ, Eskandari, M, Kreider, RB, and Wong, A. Whole egg vs. egg white ingestion', 'knee extension and handgrip strength, testosterone, and reduces body fat percentage']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C0013704', 'cui_str': 'Egg white'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0162536', 'cui_str': 'Biolectric Impedance'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0428413', 'cui_str': 'Serum testosterone measurement'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0013704', 'cui_str': 'Egg white'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0333779', 'cui_str': 'Reducing bodies'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]",,0.0494224,"There was a significant group × time interaction for body fat percentage, serum testosterone, knee extension, and handgrip strength with greater improvements observed in WER.","[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Department of Exercise Physiology, University of Isfahan, Isfahan, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Hooshmand Moghadam', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Damoon', 'Initials': 'D', 'LastName': 'Ashtary-Larky', 'Affiliation': 'Department of Clinical Biochemistry, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Forbes', 'Affiliation': 'Department of Physical Education, Brandon University, Brandon, Manitoba, Canada.'}, {'ForeName': 'Darren G', 'Initials': 'DG', 'LastName': 'Candow', 'Affiliation': 'Faculty of Kinesiology and Health Studies, University of Regina, Regina, Saskatchewan, Canada.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Galpin', 'Affiliation': 'Department of Kinesiology, Center for Sport Performance, California State University, Fullerton, Fullerton, California.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Eskandari', 'Affiliation': 'Department of Exercise Physiology, University of Birjand, Birjand, Iran.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Kreider', 'Affiliation': 'Exercise and Sport Nutrition Lab, Human Clinical Research Facility, Department of Health and Kinesiology, Texas A&M University, College Station, Texas; and.'}, {'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Health and Human Performance, Marymount University, Arlington, Texas.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003922'] 1688,33320067,US-triggered Microbubble Destruction for Augmenting Hepatocellular Carcinoma Response to Transarterial Radioembolization: A Randomized Pilot Clinical Trial.,"Background US contrast agents are gas-filled microbubbles (MBs) that can be locally destroyed by using external US. Among other bioeffects, US-triggered MB destruction, also known as UTMD, has been shown to sensitize solid tumors to radiation in preclinical models through localized insult to the vascular endothelial cells. Purpose To evaluate the safety and preliminary efficacy of combining US-triggered MB destruction and transarterial radioembolization (TARE) in participants with hepatocellular carcinoma (HCC). Materials and Methods In this pilot clinical trial, participants with HCC scheduled for sublobar TARE were randomized to undergo either TARE or TARE with US-triggered MB destruction 1-4 hours and approximately 1 and 2 weeks after TARE. Enrollment took place between July 2017 and February 2020. Safety of US-triggered MB destruction was evaluated by physiologic monitoring, changes in liver function tests, adverse events, and radiopharmaceutical distribution. Treatment efficacy was evaluated by using modified Response Evaluation Criteria in Solid Tumors (mRECIST) on cross-sectional images, time to required next treatment, transplant rates, and overall survival. Differences across mRECIST reads were compared by using a Mann-Whitney U test, and the difference in prevalence of tumor response was evaluated by Fisher exact test, whereas differences in time to required next treatment and overall survival curves were compared by using a log-rank (Mantel-Cox) test. Results Safety results from 28 participants (mean age, 70 years ± 10 [standard deviation]; 17 men) demonstrated no significant changes in temperature ( P = .31), heart rate ( P = .92), diastolic pressure ( P = .31), or systolic pressure ( P = .06) before and after US-triggered MB destruction. No changes in liver function tests between treatment arms were observed 1 month after TARE ( P > .15). Preliminary efficacy results showed a greater prevalence of tumor response (14 of 15 [93%; 95% CI: 68, 100] vs five of 10 [50%; 95% CI: 19, 81]; P = .02) in participants who underwent both US-triggered MB destruction and TARE ( P = .02). Conclusion The combination of US-triggered microbubble destruction and transarterial radioembolization is feasible with an excellent safety profile in this patient population and appears to result in improved hepatocellular carcinoma treatment response. © RSNA, 2020.",2021,No changes in liver function tests between treatment arms were observed 1 month after TARE ( P > .15).,"['28 participants (mean age, 70 years ± 10 [standard deviation]; 17 men', 'participants with HCC scheduled for sublobar TARE', 'participants with hepatocellular carcinoma (HCC']","['Transarterial Radioembolization', 'TARE or TARE', 'combining US-triggered MB destruction and transarterial radioembolization (TARE']","['liver function tests, adverse events, and radiopharmaceutical distribution', 'modified Response Evaluation Criteria in Solid Tumors (mRECIST) on cross-sectional images, time to required next treatment, transplant rates, and overall survival', 'prevalence of tumor response', 'heart rate', 'systolic pressure', 'overall survival curves', 'liver function tests', 'diastolic pressure']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0522522', 'cui_str': 'Transarterial approach'}, {'cui': 'C2985560', 'cui_str': 'Radioembolisation'}]","[{'cui': 'C0522522', 'cui_str': 'Transarterial approach'}, {'cui': 'C2985560', 'cui_str': 'Radioembolisation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1261381', 'cui_str': 'Destructive procedure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0023901', 'cui_str': 'Hepatic function panel'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0182638', 'cui_str': 'Radiopharmaceuticals'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",,0.0875777,No changes in liver function tests between treatment arms were observed 1 month after TARE ( P > .15).,"[{'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Eisenbrey', 'Affiliation': 'From the Department of Radiology (J.R.E., F.F., C.E.W., L.J.D., K.B., S.G., M.T., A.L., P.O., J.B.L., C.I., K.A., A.T., A.S., S.S.N., C.M.S.), Department of Medicine, Division of Hepatology (J.C.), Department of Surgery (W.M.), and Department of Pharmacology and Experimental Therapeutics, Division of Biostatistics (S.W.K.), Thomas Jefferson University, 132 S 10th St, 796E Main, Philadelphia, PA 19107; and Department of Surgery, Lankenau Medical Center, Wynnewood, Pa (S.G.).'}, {'ForeName': 'Flemming', 'Initials': 'F', 'LastName': 'Forsberg', 'Affiliation': 'From the Department of Radiology (J.R.E., F.F., C.E.W., L.J.D., K.B., S.G., M.T., A.L., P.O., J.B.L., C.I., K.A., A.T., A.S., S.S.N., C.M.S.), Department of Medicine, Division of Hepatology (J.C.), Department of Surgery (W.M.), and Department of Pharmacology and Experimental Therapeutics, Division of Biostatistics (S.W.K.), Thomas Jefferson University, 132 S 10th St, 796E Main, Philadelphia, PA 19107; and Department of Surgery, Lankenau Medical Center, Wynnewood, Pa (S.G.).'}, {'ForeName': 'Corinne E', 'Initials': 'CE', 'LastName': 'Wessner', 'Affiliation': 'From the Department of Radiology (J.R.E., F.F., C.E.W., L.J.D., K.B., S.G., M.T., A.L., P.O., J.B.L., C.I., K.A., A.T., A.S., S.S.N., C.M.S.), Department of Medicine, Division of Hepatology (J.C.), Department of Surgery (W.M.), and Department of Pharmacology and Experimental Therapeutics, Division of Biostatistics (S.W.K.), Thomas Jefferson University, 132 S 10th St, 796E Main, Philadelphia, PA 19107; and Department of Surgery, Lankenau Medical Center, Wynnewood, Pa (S.G.).'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'Delaney', 'Affiliation': 'From the Department of Radiology (J.R.E., F.F., C.E.W., L.J.D., K.B., S.G., M.T., A.L., P.O., J.B.L., C.I., K.A., A.T., A.S., S.S.N., C.M.S.), Department of Medicine, Division of Hepatology (J.C.), Department of Surgery (W.M.), and Department of Pharmacology and Experimental Therapeutics, Division of Biostatistics (S.W.K.), Thomas Jefferson University, 132 S 10th St, 796E Main, Philadelphia, PA 19107; and Department of Surgery, Lankenau Medical Center, Wynnewood, Pa (S.G.).'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Bradigan', 'Affiliation': 'From the Department of Radiology (J.R.E., F.F., C.E.W., L.J.D., K.B., S.G., M.T., A.L., P.O., J.B.L., C.I., K.A., A.T., A.S., S.S.N., C.M.S.), Department of Medicine, Division of Hepatology (J.C.), Department of Surgery (W.M.), and Department of Pharmacology and Experimental Therapeutics, Division of Biostatistics (S.W.K.), Thomas Jefferson University, 132 S 10th St, 796E Main, Philadelphia, PA 19107; and Department of Surgery, Lankenau Medical Center, Wynnewood, Pa (S.G.).'}, {'ForeName': 'Sriharsha', 'Initials': 'S', 'LastName': 'Gummadi', 'Affiliation': 'From the Department of Radiology (J.R.E., F.F., C.E.W., L.J.D., K.B., S.G., M.T., A.L., P.O., J.B.L., C.I., K.A., A.T., A.S., S.S.N., C.M.S.), Department of Medicine, Division of Hepatology (J.C.), Department of Surgery (W.M.), and Department of Pharmacology and Experimental Therapeutics, Division of Biostatistics (S.W.K.), Thomas Jefferson University, 132 S 10th St, 796E Main, Philadelphia, PA 19107; and Department of Surgery, Lankenau Medical Center, Wynnewood, Pa (S.G.).'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Tantawi', 'Affiliation': 'From the Department of Radiology (J.R.E., F.F., C.E.W., L.J.D., K.B., S.G., M.T., A.L., P.O., J.B.L., C.I., K.A., A.T., A.S., S.S.N., C.M.S.), Department of Medicine, Division of Hepatology (J.C.), Department of Surgery (W.M.), and Department of Pharmacology and Experimental Therapeutics, Division of Biostatistics (S.W.K.), Thomas Jefferson University, 132 S 10th St, 796E Main, Philadelphia, PA 19107; and Department of Surgery, Lankenau Medical Center, Wynnewood, Pa (S.G.).'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Lyshchik', 'Affiliation': 'From the Department of Radiology (J.R.E., F.F., C.E.W., L.J.D., K.B., S.G., M.T., A.L., P.O., J.B.L., C.I., K.A., A.T., A.S., S.S.N., C.M.S.), Department of Medicine, Division of Hepatology (J.C.), Department of Surgery (W.M.), and Department of Pharmacology and Experimental Therapeutics, Division of Biostatistics (S.W.K.), Thomas Jefferson University, 132 S 10th St, 796E Main, Philadelphia, PA 19107; and Department of Surgery, Lankenau Medical Center, Wynnewood, Pa (S.G.).'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': ""O'Kane"", 'Affiliation': 'From the Department of Radiology (J.R.E., F.F., C.E.W., L.J.D., K.B., S.G., M.T., A.L., P.O., J.B.L., C.I., K.A., A.T., A.S., S.S.N., C.M.S.), Department of Medicine, Division of Hepatology (J.C.), Department of Surgery (W.M.), and Department of Pharmacology and Experimental Therapeutics, Division of Biostatistics (S.W.K.), Thomas Jefferson University, 132 S 10th St, 796E Main, Philadelphia, PA 19107; and Department of Surgery, Lankenau Medical Center, Wynnewood, Pa (S.G.).'}, {'ForeName': 'Ji-Bin', 'Initials': 'JB', 'LastName': 'Liu', 'Affiliation': 'From the Department of Radiology (J.R.E., F.F., C.E.W., L.J.D., K.B., S.G., M.T., A.L., P.O., J.B.L., C.I., K.A., A.T., A.S., S.S.N., C.M.S.), Department of Medicine, Division of Hepatology (J.C.), Department of Surgery (W.M.), and Department of Pharmacology and Experimental Therapeutics, Division of Biostatistics (S.W.K.), Thomas Jefferson University, 132 S 10th St, 796E Main, Philadelphia, PA 19107; and Department of Surgery, Lankenau Medical Center, Wynnewood, Pa (S.G.).'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Intenzo', 'Affiliation': 'From the Department of Radiology (J.R.E., F.F., C.E.W., L.J.D., K.B., S.G., M.T., A.L., P.O., J.B.L., C.I., K.A., A.T., A.S., S.S.N., C.M.S.), Department of Medicine, Division of Hepatology (J.C.), Department of Surgery (W.M.), and Department of Pharmacology and Experimental Therapeutics, Division of Biostatistics (S.W.K.), Thomas Jefferson University, 132 S 10th St, 796E Main, Philadelphia, PA 19107; and Department of Surgery, Lankenau Medical Center, Wynnewood, Pa (S.G.).'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Civan', 'Affiliation': 'From the Department of Radiology (J.R.E., F.F., C.E.W., L.J.D., K.B., S.G., M.T., A.L., P.O., J.B.L., C.I., K.A., A.T., A.S., S.S.N., C.M.S.), Department of Medicine, Division of Hepatology (J.C.), Department of Surgery (W.M.), and Department of Pharmacology and Experimental Therapeutics, Division of Biostatistics (S.W.K.), Thomas Jefferson University, 132 S 10th St, 796E Main, Philadelphia, PA 19107; and Department of Surgery, Lankenau Medical Center, Wynnewood, Pa (S.G.).'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Maley', 'Affiliation': 'From the Department of Radiology (J.R.E., F.F., C.E.W., L.J.D., K.B., S.G., M.T., A.L., P.O., J.B.L., C.I., K.A., A.T., A.S., S.S.N., C.M.S.), Department of Medicine, Division of Hepatology (J.C.), Department of Surgery (W.M.), and Department of Pharmacology and Experimental Therapeutics, Division of Biostatistics (S.W.K.), Thomas Jefferson University, 132 S 10th St, 796E Main, Philadelphia, PA 19107; and Department of Surgery, Lankenau Medical Center, Wynnewood, Pa (S.G.).'}, {'ForeName': 'Scott W', 'Initials': 'SW', 'LastName': 'Keith', 'Affiliation': 'From the Department of Radiology (J.R.E., F.F., C.E.W., L.J.D., K.B., S.G., M.T., A.L., P.O., J.B.L., C.I., K.A., A.T., A.S., S.S.N., C.M.S.), Department of Medicine, Division of Hepatology (J.C.), Department of Surgery (W.M.), and Department of Pharmacology and Experimental Therapeutics, Division of Biostatistics (S.W.K.), Thomas Jefferson University, 132 S 10th St, 796E Main, Philadelphia, PA 19107; and Department of Surgery, Lankenau Medical Center, Wynnewood, Pa (S.G.).'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Anton', 'Affiliation': 'From the Department of Radiology (J.R.E., F.F., C.E.W., L.J.D., K.B., S.G., M.T., A.L., P.O., J.B.L., C.I., K.A., A.T., A.S., S.S.N., C.M.S.), Department of Medicine, Division of Hepatology (J.C.), Department of Surgery (W.M.), and Department of Pharmacology and Experimental Therapeutics, Division of Biostatistics (S.W.K.), Thomas Jefferson University, 132 S 10th St, 796E Main, Philadelphia, PA 19107; and Department of Surgery, Lankenau Medical Center, Wynnewood, Pa (S.G.).'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Tan', 'Affiliation': 'From the Department of Radiology (J.R.E., F.F., C.E.W., L.J.D., K.B., S.G., M.T., A.L., P.O., J.B.L., C.I., K.A., A.T., A.S., S.S.N., C.M.S.), Department of Medicine, Division of Hepatology (J.C.), Department of Surgery (W.M.), and Department of Pharmacology and Experimental Therapeutics, Division of Biostatistics (S.W.K.), Thomas Jefferson University, 132 S 10th St, 796E Main, Philadelphia, PA 19107; and Department of Surgery, Lankenau Medical Center, Wynnewood, Pa (S.G.).'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Smolock', 'Affiliation': 'From the Department of Radiology (J.R.E., F.F., C.E.W., L.J.D., K.B., S.G., M.T., A.L., P.O., J.B.L., C.I., K.A., A.T., A.S., S.S.N., C.M.S.), Department of Medicine, Division of Hepatology (J.C.), Department of Surgery (W.M.), and Department of Pharmacology and Experimental Therapeutics, Division of Biostatistics (S.W.K.), Thomas Jefferson University, 132 S 10th St, 796E Main, Philadelphia, PA 19107; and Department of Surgery, Lankenau Medical Center, Wynnewood, Pa (S.G.).'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Shamimi-Noori', 'Affiliation': 'From the Department of Radiology (J.R.E., F.F., C.E.W., L.J.D., K.B., S.G., M.T., A.L., P.O., J.B.L., C.I., K.A., A.T., A.S., S.S.N., C.M.S.), Department of Medicine, Division of Hepatology (J.C.), Department of Surgery (W.M.), and Department of Pharmacology and Experimental Therapeutics, Division of Biostatistics (S.W.K.), Thomas Jefferson University, 132 S 10th St, 796E Main, Philadelphia, PA 19107; and Department of Surgery, Lankenau Medical Center, Wynnewood, Pa (S.G.).'}, {'ForeName': 'Colette M', 'Initials': 'CM', 'LastName': 'Shaw', 'Affiliation': 'From the Department of Radiology (J.R.E., F.F., C.E.W., L.J.D., K.B., S.G., M.T., A.L., P.O., J.B.L., C.I., K.A., A.T., A.S., S.S.N., C.M.S.), Department of Medicine, Division of Hepatology (J.C.), Department of Surgery (W.M.), and Department of Pharmacology and Experimental Therapeutics, Division of Biostatistics (S.W.K.), Thomas Jefferson University, 132 S 10th St, 796E Main, Philadelphia, PA 19107; and Department of Surgery, Lankenau Medical Center, Wynnewood, Pa (S.G.).'}]",Radiology,['10.1148/radiol.2020202321'] 1689,33331859,Changes in Treatment-Naive Pigment Epithelial Detachments Associated With the Initial Anti-Vascular Endothelial Growth Factor Injection: A Post Hoc Analysis From the HARBOR Trial.,"Importance Pigment epithelial detachment (PED) is a feature commonly associated with neovascular age-related macular degeneration (nAMD) and may be perceived as being difficult to treat. Therefore, this investigation explored changes in PEDs and visual acuity outcomes following an initial anti-vascular endothelial growth factor (VEGF) injection and identified factors associated with positive response. Objective To describe changes in treatment-naive pigment epithelial detachments associated with the initial anti-VEGF injection. Design, Setting, and Participants Post hoc analysis of patients from the Phase III, Double-masked, Multicenter, Randomized, Active Treatment-controlled Study of the Efficacy and Safety of 0.5 mg and 2.0 mg Ranibizumab Administered Monthly or on an As-needed Basis in Patients With Subfoveal Neovascular Age-Related Macular Degeneration (HARBOR) trial (NCT00891735) with PED at baseline. The HARBOR trial was a phase 3, randomized, multicenter, double-masked, active treatment-controlled trial. Participants included treatment-naive patients with subfoveal nAMD and PEDs at baseline; intervention arms were pooled for analysis (n = 586). The HARBOR study began in July 2009 and was completed in August 2012, and the post hoc analyses were conducted between October 2016 and May 2018. Interventions Intravitreal injections of ranibizumab, 0.5 mg and 2.0 mg, administered monthly or on an as-needed basis over 24 months. Main Outcomes and Measures Post hoc analyses of flattened PED frequency at month 1, univariate and multivariable analysis of patient and ocular characteristics at baseline and PED status at month 1, and total number of ranibizumab injections received stratified by PED status at month 1. Results A total of 35.5% of patients (208 of 586) with PED at baseline achieved a flattened PED after a single ranibizumab injection. An additional 17.3% subsequently achieved a flattened PED at month 2. Univariate analysis identified an association between older age, lower PED height, and lower subretinal fluid thickness with PED flattening after a single injection. Multivariable analysis identified PED height as a factor associated with this anatomical outcome. Best-corrected visual acuity scores were not superior based on PED flattening at month 1. On average, patients in the as-needed arm who achieved a flattened PED after a single ranibizumab injection required fewer injections by month 24 vs patients whose PED remained present at month 1 (11.0 vs 14.2; difference, 3.3; 95% CI, 1.9-4.6; P < .001). Conclusions and Relevance In this group of treatment-naive patients with PED from nAMD, after the initial ranibizumab injection approximately one-third and after the second injection approximately one-half had flattened PEDS, although visual outcomes were not superior among those that did vs did not have flattening. The findings suggest flattening may serve as a marker for less intensive as-needed injection frequencies. Trial Registration ClinicalTrials.gov Identifier: NCT00891735.",2021,A total of 35.5% of patients (208 of 586) with PED at baseline achieved a flattened PED after a single ranibizumab injection.,"['Treatment-Naive Pigment Epithelial Detachments', 'July 2009 and was completed in August 2012, and the post hoc analyses were conducted between October 2016 and May 2018', 'Patients With Subfoveal Neovascular Age-Related Macular Degeneration (HARBOR) trial (NCT00891735) with PED at baseline', 'Participants included treatment-naive patients with subfoveal nAMD and PEDs at baseline; intervention arms were pooled for analysis (n\u2009=\u2009586']","['Importance\n\n\nPigment epithelial detachment (PED', 'Ranibizumab', 'Initial Anti-Vascular Endothelial Growth Factor Injection', 'ranibizumab']","['flattened PED frequency at month 1, univariate and multivariable analysis of patient and ocular characteristics at baseline and PED status', 'Best-corrected visual acuity scores', 'PEDs and visual acuity outcomes']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0339546', 'cui_str': 'Retinal pigment epithelial detachment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442185', 'cui_str': 'Subfoveal'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0337051', 'cui_str': 'Pool'}]","[{'cui': 'C0339546', 'cui_str': 'Retinal pigment epithelial detachment'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0339546', 'cui_str': 'Retinal pigment epithelial detachment'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.378313,A total of 35.5% of patients (208 of 586) with PED at baseline achieved a flattened PED after a single ranibizumab injection.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Javaheri', 'Affiliation': 'Retina Specialists of Beverly Hills, Beverly Hills, California.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Hill', 'Affiliation': 'Genentech Inc, South San Francisco, California.'}, {'ForeName': 'Avanti', 'Initials': 'A', 'LastName': 'Ghanekar', 'Affiliation': 'Genentech Inc, South San Francisco, California.'}, {'ForeName': 'Ivaylo', 'Initials': 'I', 'LastName': 'Stoilov', 'Affiliation': 'Genentech Inc, South San Francisco, California.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.5130'] 1690,33331850,Glaucoma-Related Adverse Events at 10 Years in the Infant Aphakia Treatment Study: A Secondary Analysis of a Randomized Clinical Trial.,"Importance Glaucoma-related adverse events constitute serious complications of cataract removal in infancy, yet long-term data on incidence and visual outcome remain lacking. Objective To identify and characterize incident cases of glaucoma and glaucoma-related adverse events (glaucoma + glaucoma suspect) among children in the Infant Aphakia Treatment Study (IATS) by the age of 10.5 years and to determine whether these diagnoses are associated with optic nerve head (ONH) and peripapillary retinal nerve fiber layer (RNFL) assessment. Design, Setting, and Participants Analysis of a multicenter randomized clinical trial of 114 infants with unilateral congenital cataract who were aged 1 to 6 months at surgery. Data on long-term glaucoma-related status and outcomes were collected when children were 10.5 years old (July 14, 2015, to July 12, 2019) and analyzed from March 30, 2019, to August 6, 2019. Interventions Participants were randomized at cataract surgery to either primary intraocular lens (IOL), or aphakia (contact lens [CL]). Standardized definitions of glaucoma and glaucoma suspect were created for IATS and applied for surveillance and diagnosis. Main Outcomes and Measures Development of glaucoma and glaucoma + glaucoma suspect in operated-on eyes up to age 10.5 years, plus intraocular pressure, axial length, RNFL (by optical coherence tomography), and ONH photographs. Results In Kaplan-Meier analysis, for all study eyes combined (n = 114), risk of glaucoma after cataract removal rose from 9% (95% CI, 5%-16%) at 1 year, to 17% (95% CI, 11%-25%) at 5 years, to 22% (95% CI, 16%-31%) at 10 years. The risk of glaucoma plus  glaucoma suspect diagnosis after cataract removal rose from 12% (95% CI, 7%-20%) at 1 year, to 31% (95% CI, 24%-41%) at 5 years, to 40% (95% CI, 32%-50%) at 10 years. Risk of glaucoma and glaucoma plus glaucoma suspect diagnosis at 10 years was not significantly different between treatment groups. Eyes with glaucoma (compared with eyes with glaucoma suspect or neither) had longer axial length but relatively preserved RNFL and similar ONH appearance and visual acuity at age 10 years. Conclusions and Relevance Risk of glaucoma-related adverse events continues to increase with longer follow-up of children following unilateral cataract removal in infancy and is not associated with primary IOL implantation. Development of glaucoma (or glaucoma suspect) after removal of unilateral congenital cataract was not associated with worse visual acuity outcomes at 10 years. Trial Registration ClinicalTrials.gov Identifier: NCT00212134.",2021,"Development of glaucoma (or glaucoma suspect) after removal of unilateral congenital cataract was not associated with worse visual acuity outcomes at 10 years. ","['114 infants with unilateral congenital cataract who were aged 1 to 6 months at surgery', 'children were 10.5 years old (July 14, 2015, to July 12, 2019) and analyzed from March 30, 2019, to August 6, 2019', 'children in the Infant Aphakia Treatment Study (IATS) by the age of 10.5 years']","['cataract surgery to either primary intraocular lens (IOL), or aphakia (contact lens [CL']","['risk of glaucoma after cataract removal rose', 'RNFL and similar ONH appearance and visual acuity', 'longer axial length', 'Main Outcomes and Measures\n\n\nDevelopment of glaucoma and glaucoma + glaucoma suspect in operated-on eyes up to age 10.5 years, plus intraocular pressure, axial length, RNFL (by optical coherence tomography), and ONH photographs', 'visual acuity outcomes']","[{'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0009691', 'cui_str': 'Congenital cataract'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0003534', 'cui_str': 'Aphakia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0003534', 'cui_str': 'Aphakia'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1444754', 'cui_str': 'Length'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C1306068', 'cui_str': 'Secondary cataract'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}, {'cui': 'C0029127', 'cui_str': 'Optic disc structure'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0017614', 'cui_str': 'Glaucoma suspect'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}]",114.0,0.255005,"Development of glaucoma (or glaucoma suspect) after removal of unilateral congenital cataract was not associated with worse visual acuity outcomes at 10 years. ","[{'ForeName': 'Sharon F', 'Initials': 'SF', 'LastName': 'Freedman', 'Affiliation': 'Department of Ophthalmology, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Allen D', 'Initials': 'AD', 'LastName': 'Beck', 'Affiliation': 'Department of Ophthalmology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Azhar', 'Initials': 'A', 'LastName': 'Nizam', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health of Emory University, Atlanta, Georgia.'}, {'ForeName': 'Deborah K', 'Initials': 'DK', 'LastName': 'Vanderveen', 'Affiliation': 'Department of Ophthalmology, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Plager', 'Affiliation': 'Department of Ophthalmology, Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Morrison', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Carolyn D', 'Initials': 'CD', 'LastName': 'Drews-Botsch', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health of Emory University, Atlanta, Georgia.'}, {'ForeName': 'Scott R', 'Initials': 'SR', 'LastName': 'Lambert', 'Affiliation': 'Department of Ophthalmology, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.5664'] 1691,33332157,The Efficacy of an Explicit Intervention Approach to Improve Past Tense Marking for Early School-Age Children With Developmental Language Disorder.,"Purpose The aim of the study was to evaluate the efficacy of a theoretically motivated explicit intervention approach to improve regular past tense marking for early school-age children with developmental language disorder (DLD). Method Twenty-one children with DLD (ages 5;9-6;9 [years;months]) were included in a crossover randomized controlled trial (intervention, n = 10; waiting control, n = 11). Intervention included once-weekly sessions over 10 weeks using the SHAPE CODING system, in combination with a systematic cueing hierarchy to teach past tense marking. Once the first group completed intervention, the waiting control group crossed over to the intervention condition. The primary outcome was criterion-referenced measures of past tense marking with standardized measures of expressive and receptive grammar as the secondary outcome. Ancillary analyses on extension and behavioral control measures of morphosyntax were also conducted. Results There was a significant Time × Group interaction ( p < .001) with a significant difference in pre-post intervention improvement in favor of the intervention group ( p < .001, d = 3.03). Further analysis once both groups had received the intervention revealed no improvement for either group on past tense production during the 5-week pre-intervention period, significant improvement pre-post intervention ( p < . 001, d = 1.22), with gains maintained for 5 weeks postintervention. No significant differences were found on pre- to postintervention standardized measures of grammar, or on extension or control measures. Conclusions The efficacy of the theoretically motivated explicit grammar intervention was demonstrated. Results contribute to the evidence base supporting this intervention to improve past tense production in early school-age children with DLD, suggesting it is a viable option for clinicians to select when treating morphosyntactic difficulties for this population. Supplemental Material https://doi.org/10.23641/asha.13345202.",2021,"Further analysis once both groups had received the intervention revealed no improvement for either group on past tense production during the 5-week pre-intervention period, significant improvement pre-post intervention ( p < .","['early school-age children with developmental language disorder (DLD', 'early school-age children with DLD', 'Method Twenty-one children with DLD (ages', 'Early School-Age Children']","['motivated explicit intervention approach', 'Explicit Intervention Approach']","['criterion-referenced measures of past tense marking with standardized measures of expressive and receptive grammar', 'extension and behavioral control measures of morphosyntax']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023014', 'cui_str': 'Developmental language disorder'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715213', 'cui_str': '21'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",21.0,0.018965,"Further analysis once both groups had received the intervention revealed no improvement for either group on past tense production during the 5-week pre-intervention period, significant improvement pre-post intervention ( p < .","[{'ForeName': 'Samuel D', 'Initials': 'SD', 'LastName': 'Calder', 'Affiliation': 'School of Occupational Therapy, Social Work, and Speech Pathology, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Claessen', 'Affiliation': 'School of Occupational Therapy, Social Work, and Speech Pathology, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Ebbels', 'Affiliation': 'Moor House Research and Training Institute, Moor House School & College, Oxted, United Kingdom.'}, {'ForeName': 'Suze', 'Initials': 'S', 'LastName': 'Leitão', 'Affiliation': 'School of Occupational Therapy, Social Work, and Speech Pathology, Curtin University, Perth, Western Australia, Australia.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2020_JSLHR-20-00132'] 1692,33325020,Hyperbaric oxygen but not hyperbaric air increases insulin sensitivity in men with type 2 diabetes mellitus.,"INTRODUCTION We have previously shown that hyperbaric oxygen treatment (HBOT) increased insulin sensitivity in men who were obese or overweight, both with and without type 2 diabetes. The aim of this study was to test whether this insulin-sensitising effect is seen in hyperbaric air (HA). METHODS Men with type 2 diabetes who were obese or overweight were randomised to two groups: HBOT (n = 13) or HA (n = 11). A hyperinsulinaemic euglycaemic glucose clamp (80 mU·m -2 ·min -1 ) was performed at baseline and during hyperbaric intervention. Both groups were compressed to 203 kPa (two atmospheres absolute) for 90 minutes followed by a linear 30-minute decompression. The HBOT group breathed oxygen via a hood while the HA group breathed chamber air. Insulin sensitivity was assessed from the glucose infusion rate (GIR) during the last 30 minutes in the hyperbaric chamber (SS1) and the first 30 minutes after exit (SS2). Data were analysed for within-group effect by paired student t-test and between-group effect by one-way ANOVA. RESULTS HBOT increased GIR by a mean 26% at SS1 (P = 0.04) and 23% at SS2 (P = 0.018). There was no significant change in GIR during or after HA. A between-group effect was evident for the change in GIR at SS1 in HBOT vs HA (P = 0.036). CONCLUSIONS The pathway by which insulin sensitivity is increased in men with type 2 diabetes requires the high oxygen partial pressures of HBOT and should be further investigated. Insulin sensitivity was not changed in hyperbaric air.",2020,"RESULTS HBOT increased GIR by a mean 26% at SS1 (P = 0.04) and 23% at SS2 (P = 0.018).","['men who were obese or overweight, both with and without type 2 diabetes', 'men with type 2 diabetes', 'men with type 2 diabetes mellitus', 'Men with type 2 diabetes who were obese or overweight']","['HBOT', 'Hyperbaric oxygen', 'hyperinsulinaemic euglycaemic glucose clamp', 'hyperbaric oxygen treatment (HBOT']","['Insulin sensitivity', 'glucose infusion rate (GIR', 'HBOT increased GIR', 'GIR', 'insulin sensitivity', 'change in GIR at SS1']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015159', 'cui_str': 'Euglycemic Clamping'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.0478413,"RESULTS HBOT increased GIR by a mean 26% at SS1 (P = 0.04) and 23% at SS2 (P = 0.018).","[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Wilkinson', 'Affiliation': 'Hyperbaric Medicine Unit, Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Chapman', 'Affiliation': 'Adelaide Medical School, The University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Leonie K', 'Initials': 'LK', 'LastName': 'Heilbronn', 'Affiliation': 'Adelaide Medical School, The University of Adelaide, Adelaide, Australia.'}]",Diving and hyperbaric medicine,['10.28920/dhm50.4.386-390'] 1693,33345430,Analysis of the Role of Plasma 25-Hydroxyvitamin D Levels in Survival Outcomes in Patients from the Phase III MPACT Trial of Metastatic Pancreatic Cancer.,"BACKGROUND We examined overall survival (OS) outcomes based on plasma 25-hydroxyvitamin D [25(OH)D] levels in this post hoc analysis of the phase III MPACT trial of metastatic pancreatic cancer. MATERIALS AND METHODS Patients were subdivided based on 25(OH)D level: sufficient (≥30 ng/mL), relatively insufficient (20-<30 ng/mL), or insufficient (<20 ng/mL). RESULTS Of 861 patients randomized in MPACT, 422 were included in this analysis. In the all-patients group, the median OS among those with insufficient, relatively insufficient, and sufficient 25(OH)D levels was 7.9, 9.4, and 7.8 months, respectively. No statistically significant OS difference was observed with relatively insufficient (p = .227) or sufficient (p = .740) versus insufficient 25(OH)D levels or with sufficient vs relatively insufficient (p = .301) 25(OH)D levels. CONCLUSION No association was observed between plasma 25(OH)D levels and survival. Further investigations are needed to understand any role of vitamin D in pancreatic cancer. Clinical trial identification number. NCT00844649.",2021,No statistically significant OS difference was observed with relatively insufficient (P = .227) or sufficient (P = .740) vs insufficient 25(OH)D levels or with sufficient vs relatively insufficient (P = .301),"['patients from the phase III MPACT trial of metastatic pancreatic cancer', 'Patients were subdivided based on 25(OH)D level: sufficient (≥\u200930 ng/mL', '861 patients randomized in']",['MPACT'],"['plasma 25-hydroxyvitamin D levels', '25(OH)D levels', 'plasma 25-hydroxyvitamin D (25[OH]D) levels', 'OS difference', 'plasma 25(OH)D levels and survival', 'median OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0346976', 'cui_str': 'Secondary malignant neoplasm of pancreas'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]",[],"[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",861.0,0.104345,No statistically significant OS difference was observed with relatively insufficient (P = .227) or sufficient (P = .740) vs insufficient 25(OH)D levels or with sufficient vs relatively insufficient (P = .301),"[{'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Von Hoff', 'Affiliation': 'Molecular Medicine Division, Translational Genomics Research Institute, Phoenix, Arizona, USA.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Cridebring', 'Affiliation': 'Molecular Medicine Division, Translational Genomics Research Institute, Phoenix, Arizona, USA.'}, {'ForeName': 'Olivia Yu', 'Initials': 'OY', 'LastName': 'Tian', 'Affiliation': 'Bristol Myers Squibb Company, Princeton, New Jersey, USA.'}, {'ForeName': 'Haiyong', 'Initials': 'H', 'LastName': 'Han', 'Affiliation': 'Molecular Medicine Division, Translational Genomics Research Institute, Phoenix, Arizona, USA.'}, {'ForeName': 'Rafia', 'Initials': 'R', 'LastName': 'Bhore', 'Affiliation': 'Bristol Myers Squibb Company, Princeton, New Jersey, USA.'}, {'ForeName': 'Twyla', 'Initials': 'T', 'LastName': 'Franco', 'Affiliation': 'Bristol Myers Squibb Company, Princeton, New Jersey, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Ondovik', 'Affiliation': 'Bristol Myers Squibb Company, Princeton, New Jersey, USA.'}, {'ForeName': 'Chrystal U', 'Initials': 'CU', 'LastName': 'Louis', 'Affiliation': 'Bristol Myers Squibb Company, Princeton, New Jersey, USA.'}]",The oncologist,['10.1002/onco.13645'] 1694,33345396,"Benefit-Risk Summary of Nivolumab for the Treatment of Patients with Unresectable Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma After Prior Fluoropyrimidine- and Platinum-Based Chemotherapy.","On June 10, 2020, the U.S. Food and Drug Administration (FDA) approved nivolumab (OPDIVO; Bristol Myers Squibb, New York, NY) for the treatment of patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. Approval was based on the results of a single, randomized, active-control study (ATTRACTION-3) that randomized patients to receive nivolumab or investigator's choice of taxane chemotherapy (docetaxel or paclitaxel). The study demonstrated a significant improvement in overall survival (OS; hazard ratio = 0.77; 95% confidence interval: 0.62-0.96; p = .0189) with an estimated median OS of 10.9 months in the nivolumab arm compared with 8.4 months in the chemotherapy arm. Overall, fewer patients in the nivolumab arm experienced treatment-emergent adverse events (TEAEs) of any grade, grade 3-4 TEAEs, and serious adverse events compared with the control arm. The safety profile of nivolumab in patients with ESCC was generally similar to the known safety profile of nivolumab in other cancer types with the following exception: esophageal fistula was identified as a new, clinically significant risk in patients with ESCC treated with nivolumab. Additionally, the incidence of pneumonitis was higher in the ESCC population than in patients with other cancer types who are treated with nivolumab. This article summarizes the FDA review of the data supporting the approval of nivolumab for the treatment of ESCC. IMPLICATIONS FOR PRACTICE: The approval of nivolumab for the treatment of adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy was based on an overall survival (OS) benefit from a randomized, open-label, active-controlled study called ATTRACTION-3. Prior to this study, no drug or combination regimen had demonstrated an OS benefit in a randomized study for patients with ESCC after prior fluoropyrimidine- and platinum-based chemotherapy.",2021,The study demonstrated a significant improvement in overall survival (OS; hazard ratio = 0.77; 95% confidence interval: 0.62-0.96; p = .0189) with an estimated median OS of 10.9 months in the nivolumab arm compared with 8.4 months in the chemotherapy arm.,"['patients with ESCC', 'patients with ESCC after prior', 'adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) after prior', 'Patients with Unresectable Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma', 'patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) after prior', 'patients with ESCC treated with nivolumab']","['nivolumab', 'Nivolumab', 'fluoropyrimidine- and platinum-based chemotherapy', 'taxane chemotherapy (docetaxel or paclitaxel', 'Food and Drug Administration (FDA) approved nivolumab (OPDIVO', 'Fluoropyrimidine- and Platinum-Based Chemotherapy']","['incidence of pneumonitis', 'treatment-emergent adverse events (TEAEs) of any grade, grade 3-4 TEAEs, and serious adverse events', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1142025', 'cui_str': 'Oesophageal squamous cell carcinoma stage IV'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C3872108', 'cui_str': 'Opdivo'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C3714636', 'cui_str': 'Pneumonitis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.0418394,The study demonstrated a significant improvement in overall survival (OS; hazard ratio = 0.77; 95% confidence interval: 0.62-0.96; p = .0189) with an estimated median OS of 10.9 months in the nivolumab arm compared with 8.4 months in the chemotherapy arm.,"[{'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Pelosof', 'Affiliation': 'Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'May Tun', 'Initials': 'MT', 'LastName': 'Saung', 'Affiliation': 'Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Donoghue', 'Affiliation': 'Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Casak', 'Affiliation': 'Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Sirisha', 'Initials': 'S', 'LastName': 'Mushti', 'Affiliation': 'Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Xiling', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Khazraee', 'Affiliation': 'Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Kirsten B', 'Initials': 'KB', 'LastName': 'Goldberg', 'Affiliation': 'Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Theoret', 'Affiliation': 'Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Lemery', 'Affiliation': 'Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pazdur', 'Affiliation': 'Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Lola', 'Initials': 'L', 'LastName': 'Fashoyin-Aje', 'Affiliation': 'Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}]",The oncologist,['10.1002/onco.13646'] 1695,33819336,Clinical Outcomes and Gingival Blood Flowmetry of Two Types of Subepithelial Connective Tissue Graft for Root Coverage in Multiple Gingival Recessions: A Preliminary Study.,"This randomized split-mouth preliminary clinical trial aimed to evaluate periodontal parameters and gingival blood flowmetry, comparing sites that received subepithelial connective tissue graft from the palate after deepithelialization (DE) or obtained with parallel incision (PI). Periodontal parameters were evaluated at baseline and 6 months postoperative. Gingival blood flows were analyzed by laser Doppler flowmetry (LDF) at baseline and 2, 7, and 14 days postoperative. Statistical and LDF analyses were performed with R version 3.5.1 and MATLAB software, and clinical parameters through ANOVA and Wilcoxon signed-rank tests. LDF showed superior decrease in power spectral density (PSD) for DE after 2 days. After 7 days, PSD returned to initial values only for PI, and DE had not returned to the initial values by day 14. Despite major initial revascularization challenges for DE sites, both grafts promoted satisfactory root coverage in the treatment of multiple gingival recessions.",2021,"Despite major initial revascularization challenges for DE sites, both grafts promoted satisfactory root coverage in the treatment of multiple gingival recessions.",['Multiple Gingival Recessions'],"['subepithelial connective tissue graft from the palate after deepithelialization (DE) or obtained with parallel incision (PI', 'LDF']","['Gingival blood flows', 'power spectral density (PSD']","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}]","[{'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0162520', 'cui_str': 'Laser doppler flowmetry'}]","[{'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0178587', 'cui_str': 'Density'}]",,0.0266908,"Despite major initial revascularization challenges for DE sites, both grafts promoted satisfactory root coverage in the treatment of multiple gingival recessions.","[{'ForeName': 'Mariana Schutzer', 'Initials': 'MS', 'LastName': 'Ragghianti-Zangrando', 'Affiliation': ''}, {'ForeName': 'Nair Cristina', 'Initials': 'NC', 'LastName': 'Margarido Brondino', 'Affiliation': ''}, {'ForeName': 'Carla Andreotti', 'Initials': 'CA', 'LastName': 'Damante', 'Affiliation': ''}, {'ForeName': 'Ísis', 'Initials': 'Í', 'LastName': 'de Fátima Balderrama', 'Affiliation': ''}, {'ForeName': 'Giovana Fuzeto', 'Initials': 'GF', 'LastName': 'Veronesi', 'Affiliation': ''}, {'ForeName': 'Matheus Völz', 'Initials': 'MV', 'LastName': 'Cardoso', 'Affiliation': ''}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': ""Campos Passanezi Sant'Ana"", 'Affiliation': ''}]",The International journal of periodontics & restorative dentistry,['10.11607/prd.4353'] 1696,33347012,"Allogeneic PRP for Rotator Cuff Disease: A Step Closer to an ""Off-the-Shelf"" Biologic Treatment?: Commentary on an article by Chris Hyunchul Jo, MD, et al.: ""Allogeneic Platelet-Rich Plasma Versus Corticosteroid Injection for the Treatment of Rotator Cuff Disease. A Randomized Controlled Trial"".",,2020,,['Rotator Cuff Disease'],"['Allogeneic PRP', 'Allogeneic Platelet-Rich Plasma Versus Corticosteroid Injection']",[],"[{'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0032027', 'cui_str': 'Pityriasis rubra pilaris'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]",[],,0.0238145,,"[{'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Werner', 'Affiliation': 'Department of Orthopaedic Surgery, University of Virginia, Charlottesville, Virginia.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.20.01665'] 1697,33347002,"Efficacy and Safety of a Novel Botulinum Toxin A for Masseter Reduction: A Randomized, Double-Blind, Placebo-Controlled, Optimal Dose-Finding Study.","BACKGROUND A wide lower face and a square jaw are considered esthetic problems, particularly in Asia. OBJECTIVE To investigate the optimal dose of a novel botulinum toxin (prabotulinum toxin A) for treating masseteric hypertrophy. METHODS Ninety subjects with masseteric hypertrophy were randomly divided into 5 groups and treated with placebo (A, normal saline) or prabotulinum toxin A (B: 24, C: 48, D: 72, and E: 96 units). Photography, ultrasonography, and 3-dimensional imaging were performed before and after injection at baseline and at 4, 8, 12, and 16 weeks after treatment. The participants also rated their satisfaction. RESULTS Masseter thickness significantly reduced in all groups at 12 weeks, compared with that in the placebo group. A dose-dependent reduction in masseter thickness was observed at the resting and maximal clenching positions. Sonography and 3-dimensional imaging revealed a gradual reduction in masseter thickness and volume, respectively, during the first 12 weeks. Despite being slightly effective, a dose of 24 units might be insufficient for resolving square face problems. Patients in Group E reported discomfort during jaw movement. CONCLUSION Prabotulinum toxin A could effectively improve lower face contour without major complications, with an optimal dose of 48 to 72 units, followed by reinjection after 12 weeks.",2021,"Masseter thickness significantly reduced in all groups at 12 weeks, compared with that in the placebo group.","['Ninety subjects with masseteric hypertrophy', 'Masseter Reduction']","['novel botulinum toxin (prabotulinum toxin A', 'placebo', 'Novel Botulinum Toxin A', 'placebo (A, normal saline) or prabotulinum toxin A', 'Sonography and 3-dimensional imaging', 'Placebo']","['masseter thickness', 'Masseter thickness', 'Efficacy and Safety', 'discomfort during jaw movement']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0024876', 'cui_str': 'Masseter muscle structure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0006055', 'cui_str': 'botulinum toxin'}, {'cui': 'C0076851', 'cui_str': 'toxin A (Pseudomonas)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]","[{'cui': 'C0024876', 'cui_str': 'Masseter muscle structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0596807', 'cui_str': 'Moving jaw'}]",90.0,0.272233,"Masseter thickness significantly reduced in all groups at 12 weeks, compared with that in the placebo group.","[{'ForeName': 'Ji Yeon', 'Initials': 'JY', 'LastName': 'Hong', 'Affiliation': 'All authors are affiliated with the Department of Dermatology, College of Medicine, Chung-Ang University, Seoul, South Korea.'}, {'ForeName': 'Guk Jin', 'Initials': 'GJ', 'LastName': 'Jeong', 'Affiliation': ''}, {'ForeName': 'Tae-Rin', 'Initials': 'TR', 'LastName': 'Kwon', 'Affiliation': ''}, {'ForeName': 'Jong Hwan', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Kapsok', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Beom Joon', 'Initials': 'BJ', 'LastName': 'Kim', 'Affiliation': ''}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002475'] 1698,33350893,Nonspherical Polyvinyl Alcohol Particles versus Tris-Acryl Microspheres: Randomized Controlled Trial Comparing Pain after Uterine Artery Embolization for Symptomatic Fibroids.,"Background Data are limited regarding comparison between nonspherical polyvinyl alcohol (PVA) particles and tris-acryl gelatin microspheres (TAGM) in uterine artery embolization (UAE). Purpose To compare pain after UAE with PVA versus TAGM for treatment of symptomatic fibroids. Materials and Methods In this randomized clinical trial, participants were assigned to be administered nonspherical PVA (355-550 μm) or TAGM (500-700 μm). Both groups were administered fentanyl-based intravenous patient-controlled analgesia during the first 24 hours after UAE and rescue analgesics. Neutrophil-to-lymphocyte ratio was measured to assess inflammatory response. Contrast-enhanced MRI 1 day after UAE was used to evaluate dominant fibroid necrosis and ischemia of normal myometrium. Symptom severity score and health-related quality-of-life score were assessed before and 3 months after UAE. Variables measured over time were analyzed by using the generalized estimating equation method. Results A total of 54 participants (mean age, 44 years ± 4 [standard deviation]) were evaluated (27 participants in each group). Although pain scores and fentanyl dose were not different during the first 24 hours, use of rescue analgesics was higher in the PVA group (33% vs 11%; P = .049). After embolization, symptom severity score and health-related quality-of-life score were not different between groups (symptom severity score: 16 [interquartile range, 6-22] for PVA vs 19 [interquartile range, 9-34] for TAGM, P = .45; health-related quality-of-life score: 93 [interquartile range, 80-97] for PVA vs 89 [interquartile range, 84-96] for TAGM, P = .41). Changes in neutrophil-to-lymphocyte ratio from before to 24 hours after UAE were greater in the PVA group (3.9 [interquartile range, 2.7-6.8] for PVA and 2.5 [interquartile range, 1.5-4.6] for TAGM; P = .02). Rates of complete dominant fibroid necrosis were not different between groups, but transient global uterine ischemia of normal myometrium was more frequent in the PVA group (44% vs 15%; P = .04). Conclusion When used in uterine artery embolization, polyvinyl alcohol particles and tris-acryl gelatin microspheres resulted in similar pain scores and fentanyl dose. Polyvinyl alcohol resulted in a greater inflammatory response, higher rates of rescue analgesic use, and more frequent transient global uterine ischemia. © RSNA, 2020 See also the editorial by Spies and Frenk in this issue.",2021,"Polyvinyl alcohol resulted in a greater inflammatory response, higher rates of rescue analgesic use, and more frequent transient global uterine ischemia.","['54 participants (mean age, 44 years ± 4 [standard deviation]) were evaluated (27 participants in each group', 'Symptomatic Fibroids', 'symptomatic fibroids']","['Nonspherical Polyvinyl Alcohol Particles versus Tris-Acryl Microspheres', 'nonspherical PVA', 'nonspherical polyvinyl alcohol (PVA) particles and tris-acryl gelatin microspheres (TAGM', 'Polyvinyl alcohol', 'fentanyl-based intravenous patient-controlled analgesia', 'TAGM', 'Pain after Uterine Artery Embolization', 'PVA versus TAGM']","['transient global uterine ischemia of normal myometrium', 'symptom severity score and health-related quality-of-life score', 'inflammatory response', 'rescue analgesics', 'pain scores', 'Neutrophil-to-lymphocyte ratio', 'neutrophil-to-lymphocyte ratio', 'Symptom severity score and health-related quality-of-life score', 'Rates of complete dominant fibroid necrosis']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0023267', 'cui_str': 'Leiomyofibroma'}]","[{'cui': 'C0032623', 'cui_str': 'Polyvinyl Alcohol'}, {'cui': 'C0041175', 'cui_str': 'Tromethamine'}, {'cui': 'C0026032', 'cui_str': 'Microbeads'}, {'cui': 'C0017237', 'cui_str': 'Gelatin'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0729536', 'cui_str': 'Embolization of uterine artery'}]","[{'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0853070', 'cui_str': 'Uterine ischaemia'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0027088', 'cui_str': 'Myometrial structure'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0023267', 'cui_str': 'Leiomyofibroma'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}]",54.0,0.212495,"Polyvinyl alcohol resulted in a greater inflammatory response, higher rates of rescue analgesic use, and more frequent transient global uterine ischemia.","[{'ForeName': 'Kichang', 'Initials': 'K', 'LastName': 'Han', 'Affiliation': 'From the Department of Radiology, Severance Hospital (K.H., J.H.K., G.M.K., J.L., J.Y.W., M.D.K.), Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute (S.Y.K., H.J.K., E.J.Y.), and Biostatistics Collaboration Unit, Department of Biomedical Systems Informatics (H.J.S.), Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea.'}, {'ForeName': 'So Yeon', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'From the Department of Radiology, Severance Hospital (K.H., J.H.K., G.M.K., J.L., J.Y.W., M.D.K.), Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute (S.Y.K., H.J.K., E.J.Y.), and Biostatistics Collaboration Unit, Department of Biomedical Systems Informatics (H.J.S.), Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea.'}, {'ForeName': 'Hyun Joo', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'From the Department of Radiology, Severance Hospital (K.H., J.H.K., G.M.K., J.L., J.Y.W., M.D.K.), Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute (S.Y.K., H.J.K., E.J.Y.), and Biostatistics Collaboration Unit, Department of Biomedical Systems Informatics (H.J.S.), Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea.'}, {'ForeName': 'Joon Ho', 'Initials': 'JH', 'LastName': 'Kwon', 'Affiliation': 'From the Department of Radiology, Severance Hospital (K.H., J.H.K., G.M.K., J.L., J.Y.W., M.D.K.), Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute (S.Y.K., H.J.K., E.J.Y.), and Biostatistics Collaboration Unit, Department of Biomedical Systems Informatics (H.J.S.), Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea.'}, {'ForeName': 'Gyoung Min', 'Initials': 'GM', 'LastName': 'Kim', 'Affiliation': 'From the Department of Radiology, Severance Hospital (K.H., J.H.K., G.M.K., J.L., J.Y.W., M.D.K.), Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute (S.Y.K., H.J.K., E.J.Y.), and Biostatistics Collaboration Unit, Department of Biomedical Systems Informatics (H.J.S.), Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea.'}, {'ForeName': 'Junhyung', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'From the Department of Radiology, Severance Hospital (K.H., J.H.K., G.M.K., J.L., J.Y.W., M.D.K.), Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute (S.Y.K., H.J.K., E.J.Y.), and Biostatistics Collaboration Unit, Department of Biomedical Systems Informatics (H.J.S.), Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea.'}, {'ForeName': 'Jong Yun', 'Initials': 'JY', 'LastName': 'Won', 'Affiliation': 'From the Department of Radiology, Severance Hospital (K.H., J.H.K., G.M.K., J.L., J.Y.W., M.D.K.), Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute (S.Y.K., H.J.K., E.J.Y.), and Biostatistics Collaboration Unit, Department of Biomedical Systems Informatics (H.J.S.), Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea.'}, {'ForeName': 'Hye Jung', 'Initials': 'HJ', 'LastName': 'Shin', 'Affiliation': 'From the Department of Radiology, Severance Hospital (K.H., J.H.K., G.M.K., J.L., J.Y.W., M.D.K.), Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute (S.Y.K., H.J.K., E.J.Y.), and Biostatistics Collaboration Unit, Department of Biomedical Systems Informatics (H.J.S.), Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea.'}, {'ForeName': 'Eun Jang', 'Initials': 'EJ', 'LastName': 'Yoon', 'Affiliation': 'From the Department of Radiology, Severance Hospital (K.H., J.H.K., G.M.K., J.L., J.Y.W., M.D.K.), Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute (S.Y.K., H.J.K., E.J.Y.), and Biostatistics Collaboration Unit, Department of Biomedical Systems Informatics (H.J.S.), Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea.'}, {'ForeName': 'Man-Deuk', 'Initials': 'MD', 'LastName': 'Kim', 'Affiliation': 'From the Department of Radiology, Severance Hospital (K.H., J.H.K., G.M.K., J.L., J.Y.W., M.D.K.), Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute (S.Y.K., H.J.K., E.J.Y.), and Biostatistics Collaboration Unit, Department of Biomedical Systems Informatics (H.J.S.), Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea.'}]",Radiology,['10.1148/radiol.2020201895'] 1699,33358148,Different degree of intervention in 6-month weight-loss support and arterial stiffness: Secondary analysis of a randomized controlled trial.,"BACKGROUND AND AIMS Weight reduction by lifestyle modification (i.e., low-calorie diet and/or exercise) decreases arterial stiffness in overweight or obese individuals. We previously demonstrated that weight loss differs depending on the degree of intervention in weight-loss support in a randomized controlled trial (UMIN000001259). However, the effect of different degrees of intervention on arterial stiffness remains unclear. METHODS AND RESULTS A total of 188 middle-aged men and women with overweight or obesity (51 ± 7 years, BMI: 29.0 ± 3.2 kg/m 2 ) participated in the 6-month trial wherein they were assigned to a low (LI, n = 63), moderate (MI, n = 62), or high intensive intervention (HI, n = 63) group. Initially, one motivational lecture on weight loss was provided to all three groups, whereas educational materials (textbooks, notebooks, and a pedometer) were provided to groups MI and HI. Additionally, the HI group participated in a series of group-based sessions. Body weight and arterial stiffness assessed by brachial-ankle pulse wave velocity (baPWV) were measured at 0, 3, and 6 months. Six-month weight loss was greater in the order of HI, MI, and LI groups. The interventions reduced baPWV in all groups, and the reduction was not significantly different among the groups (114.3 ± 16.3, 82.6 ± 15.2, and 98.8 ± 90.4 cm/s, respectively). CONCLUSION In overweight or obese individuals, different degrees of intervention in weight-loss support affect body weight; however, the extent to which arterial stiffness improves does not differ among support programs.",2021,"The interventions reduced baPWV in all groups, and the reduction was not significantly different among the groups (114.3 ± 16.3, 82.6 ± 15.2, and 98.8 ± 90.4 cm/s, respectively). ","['overweight or obese individuals', '188 middle-aged men and women with overweight or obesity (51 ± 7 years, BMI: 29.0 ± 3.2 kg/m 2 ) participated in the 6-month trial wherein they were assigned to a low (LI, n = 63), moderate (MI, n = 62), or high intensive intervention (HI, n = 63) group']",['low-calorie diet and/or exercise'],"['weight loss', 'Body weight and arterial stiffness assessed by brachial-ankle pulse wave velocity (baPWV', 'Six-month weight loss', 'arterial stiffness', 'baPWV']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0232154', 'cui_str': 'Ankle pulse'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C4082120', 'cui_str': 'Six months'}]",188.0,0.0365078,"The interventions reduced baPWV in all groups, and the reduction was not significantly different among the groups (114.3 ± 16.3, 82.6 ± 15.2, and 98.8 ± 90.4 cm/s, respectively). ","[{'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Tanabe', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Nakata', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Asako', 'Initials': 'A', 'LastName': 'Zempo-Miyaki', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Ibaraki, Japan; Faculty of Sport and Health Sciences, Ryutsu Keizai University, Ibaraki, Japan.'}, {'ForeName': 'Mutsuko Y', 'Initials': 'MY', 'LastName': 'Hieda', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Ibaraki, Japan; Institute of Liberal Arts and Science, Toyohashi University of Technology, Aichi, Japan.'}, {'ForeName': 'Youngju', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Ibaraki, Japan; Institute of Sports & Arts Convergence, Inha University, Incheon, Republic of Korea.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Fujii', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Maeda', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Ibaraki, Japan. Electronic address: maeda.seiji.gn@u.tsukuba.ac.jp.'}]",Obesity research & clinical practice,['10.1016/j.orcp.2020.11.006'] 1700,32505131,Effect of treatment on cognitive and attention problems in children with narcolepsy type 1.,"STUDY OBJECTIVES To ascertain the presence of cognitive and attention problems in treatment naïve children with narcolepsy type 1 (NT1) and to explore whether children recently diagnosed with NT1 improve with respect to cognition and attention problems 1 year after regular treatment for NT1. METHODS A total of 15 treatment naïve children (7-15 years) with recently diagnosed NT1 were recruited from three sleep medicine centers in the Netherlands. The control group consisted of 15 healthy children, being frequency matched on age and gender. Both groups were investigated at baseline to examine intelligence profile (Wechsler Intelligence Scale for Children [WISC] III), attention problems, and processing speed (Bourdon Vos and sustained attention to respond task [SART]). These tests were repeated in children with NT1 1 year after regular (behavioral and medication) treatment for NT1. RESULTS Children with NT1 scored significantly lower on the verbal scale and processing speed subscale of the WISC III, showed more fluctuations in reaction time of the Bourdon Vos and made more mistakes during the SART than the healthy control group at baseline. Children with NT1 significantly improved on total IQ score, and on the WISC indices processing speed, and perceptual organization 1 year after treatment. At follow-up, test scores of treated children were largely comparable to those of the control group at baseline. CONCLUSIONS Children with NT1 show improvement in several cognitive domains 1 year after start of treatment. Our findings stress the need for early detection and treatment of narcolepsy in childhood.",2020,"Children with NT1 significantly improved on total IQ score, and on the WISC indices processing speed, and perceptual organization 1 year after treatment.","['naïve children with narcolepsy type 1 (NT1', 'children with narcolepsy type 1', 'A total of 15 treatment naïve children (7-15 years) with recently diagnosed NT1 were recruited from three sleep medicine centers in the Netherlands', 'children with NT1 1 year after regular (behavioral and medication) treatment for NT1', '15 healthy children, being frequency matched on age and gender']",['NT1'],"['cognitive and attention problems', 'intelligence profile (Wechsler Intelligence Scale for Children [WISC] III), attention problems, and processing speed (Bourdon Vos and sustained attention to respond task [SART', 'verbal scale and processing speed subscale', 'total IQ score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4543926', 'cui_str': 'Narcolepsy type 1'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4304028', 'cui_str': 'Sleep medicine specialist'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]","[{'cui': 'C4543926', 'cui_str': 'Narcolepsy type 1'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C0204457', 'cui_str': 'Wechsler intelligence scale for children'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",15.0,0.0323703,"Children with NT1 significantly improved on total IQ score, and on the WISC indices processing speed, and perceptual organization 1 year after treatment.","[{'ForeName': 'Karin A M', 'Initials': 'KAM', 'LastName': 'Janssens', 'Affiliation': 'Sleep-Wake Centre, Stichting Epilepsie Instellingen Nederland (SEIN), Zwolle/Heemstede, The Netherlands.'}, {'ForeName': 'Laury', 'Initials': 'L', 'LastName': 'Quaedackers', 'Affiliation': 'Center for Sleep Medicine, Kempenhaeghe, Heeze, The Netherlands.'}, {'ForeName': 'Gert Jan', 'Initials': 'GJ', 'LastName': 'Lammers', 'Affiliation': 'Sleep-Wake Centre, Stichting Epilepsie Instellingen Nederland (SEIN), Zwolle/Heemstede, The Netherlands.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Amesz', 'Affiliation': 'Sleep-Wake Centre, Stichting Epilepsie Instellingen Nederland (SEIN), Zwolle/Heemstede, The Netherlands.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'van Mierlo', 'Affiliation': 'Center for Sleep Medicine, Kempenhaeghe, Heeze, The Netherlands.'}, {'ForeName': 'Lisanne', 'Initials': 'L', 'LastName': 'Aarts', 'Affiliation': 'Center for Sleep Medicine, Kempenhaeghe, Heeze, The Netherlands.'}, {'ForeName': 'Els', 'Initials': 'E', 'LastName': 'Peeters', 'Affiliation': ""Department of Child Neurology, Juliana Children's Hospital-Haga Teaching Hospital, The Hague, The Netherlands.""}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Hendriks', 'Affiliation': 'Sleeping Center, Medical Centre Haaglanden, The Hague, The Netherlands.'}, {'ForeName': 'Nele', 'Initials': 'N', 'LastName': 'Vandenbussche', 'Affiliation': 'Center for Sleep Medicine, Kempenhaeghe, Heeze, The Netherlands.'}, {'ForeName': 'Sebastiaan', 'Initials': 'S', 'LastName': 'Overeem', 'Affiliation': 'Center for Sleep Medicine, Kempenhaeghe, Heeze, The Netherlands.'}, {'ForeName': 'Sigrid', 'Initials': 'S', 'LastName': 'Pillen', 'Affiliation': 'Center for Sleep Medicine, Kempenhaeghe, Heeze, The Netherlands.'}]",Sleep,['10.1093/sleep/zsaa114'] 1701,33317326,Gender-Based Differences in Outcomes Among Resuscitated Patients With Out-of-Hospital Cardiac Arrest.,"BACKGROUND Studies examining gender-based differences in outcomes of patients experiencing out-of-hospital cardiac arrest have demonstrated that, despite a higher likelihood of return of spontaneous circulation, women do not have higher survival. METHODS Patients successfully resuscitated from out-of-hospital cardiac arrest enrolled in the CCC trial (Trial of Continuous or Interrupted Chest Compressions during CPR) were included. Hierarchical multivariable logistic regression models were constructed to evaluate the association between gender and survival after adjustment for age, gender, cardiac arrest rhythm, witnessed status, bystander cardiopulmonary resuscitation, episode location, epinephrine dose, emergency medical services response time, and duration of resuscitation. Do not resuscitate (DNR) and withdrawal of life-sustaining therapy (WLST) order status were used to assess whether differences in postresuscitation outcomes were modified by baseline prognosis. The analysis was replicated among ALPS trial (Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest) participants. RESULTS Among 4875 successfully resuscitated patients, 1825 (37.4%) were women and 3050 (62.6%) were men. Women were older (67.5 versus 65.3 years), received less bystander cardiopulmonary resuscitation (49.1% versus 54.9%), and had a lower proportion of cardiac arrests that were witnessed (55.1% versus 64.5%) or had shockable rhythm (24.3% versus 44.6%, P <0.001 for all). A significantly higher proportion of women received DNR orders (35.7% versus 32.1%, P =0.009) and had WLST (32.8% versus 29.8%, P =0.03). Discharge survival was significantly lower in women (22.5% versus 36.3%, P <0.001; adjusted odds ratio, 0.78 [95% CI, 0.66-0.93]; P =0.005). The association between gender and survival to discharge was modified by DNR and WLST order status such that women had significantly reduced survival to discharge among patients who were not designated DNR (31.3% versus 49.9%, P =0.005; adjusted odds ratio, 0.74 [95% CI, 0.60-0.91]) or did not have WLST (32.3% versus 50.7%, P =0.002; adjusted odds ratio, 0.73 [95% CI, 0.60-0.89]). In contrast, no gender difference in survival was noted among patients receiving a DNR order (6.7% versus 7.4%, P =0.90) or had WLST (2.8% versus 2.4%, P =0.93). Consistent patterns of association between gender and postresuscitation outcomes were observed in the secondary cohort. CONCLUSIONS Among patients resuscitated after experiencing out-of-hospital cardiac arrest, discharge survival was significantly lower in women than in men, especially among patients considered to have a favorable prognosis.",2021,"Among resuscitated out-of-hospital cardiac arrest patients, discharge to survival was significantly lower in women compared with men especially among patients considered to have a favorable prognosis.","['Resuscitated Patients with Out-of-Hospital Cardiac Arrest', '4,875 successfully resuscitated patients, 1,825 (37.4%) were women and 3,050 (62.6%) were men', 'Patients successfully resuscitated from out-of-hospital cardiac arrest enrolled in the Continuous Chest Compression trial were included']","['Amiodarone, Lidocaine']","['survival', 'gender and discharge survival', 'discharge to survival', 'Discharge survival', 'bystander cardiopulmonary resuscitation', 'discharge survival', 'WLST', 'shockable rhythm']","[{'cui': 'C2587207', 'cui_str': 'For resuscitation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C4517741', 'cui_str': '37.4'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]",4875.0,0.153359,"Among resuscitated out-of-hospital cardiac arrest patients, discharge to survival was significantly lower in women compared with men especially among patients considered to have a favorable prognosis.","[{'ForeName': 'Purav', 'Initials': 'P', 'LastName': 'Mody', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine (P.M., A.P., M.W.S.), University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Ambarish', 'Initials': 'A', 'LastName': 'Pandey', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine (P.M., A.P., M.W.S.), University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Arthur S', 'Initials': 'AS', 'LastName': 'Slutsky', 'Affiliation': ""Keenan Research Center for Biomedical Science at the Li Ka Shing Knowledge Institute, St. Michael's Hospital, Departments of Medicine, Surgery, and Biomedical Engineering, Interdepartmental Division of Critical Care (A.S.S.), University of Toronto, Ontario, Canada.""}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Segar', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine (P.M., A.P., M.W.S.), University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kiss', 'Affiliation': 'Evaluative Clinical Sciences, Hurvitz Brain Sciences Program, Sunnybrook Research Institute, Institute for Health Policy and Management (A.K.), University of Toronto, Ontario, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dorian', 'Affiliation': ""Division of Cardiology, St Michael's Hospital, Division of Cardiology, Department of Medicine, Faculty of Medicine, Institute of Medical Sciences (P.D.), University of Toronto, Ontario, Canada.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Parsons', 'Affiliation': ""Applied Health Research Centre at the Li Ka Shing Knowledge Institute, St Michael's Hospital, Department of Physical Therapy and the Rehabilitation Sciences Institute (J.P.), University of Toronto, Ontario, Canada.""}, {'ForeName': 'Damon C', 'Initials': 'DC', 'LastName': 'Scales', 'Affiliation': 'Sunnybrook Health Sciences Center, Interdepartmental Division of Critical Care Medicine, Faculty of Medicine, Institute for Health Policy and Management (D.C.S.), University of Toronto, Ontario, Canada.'}, {'ForeName': 'Valeria E', 'Initials': 'VE', 'LastName': 'Rac', 'Affiliation': 'Ted Rogers Centre for Heart Research and Peter Munk Cardiac Centre and Toronto General Hospital Research Institute, Toronto Health Economics and Technology Assessment (THETA) Collaborative, Institute of Health Policy, Management and Evaluation (V.E.R.), University of Toronto, Ontario, Canada.'}, {'ForeName': 'Sheldon', 'Initials': 'S', 'LastName': 'Cheskes', 'Affiliation': 'Sunnybrook Centre for Prehospital Medicine, Division of Emergency Medicine, Department of Family and Community Medicine (S.C.), University of Toronto, Ontario, Canada.'}, {'ForeName': 'Arlene S', 'Initials': 'AS', 'LastName': 'Bierman', 'Affiliation': 'Centre for Practice Improvement, Agency for Healthcare Research and Quality, Rockville, MD (A.S.B.).'}, {'ForeName': 'Beth L', 'Initials': 'BL', 'LastName': 'Abramson', 'Affiliation': ""Division of Cardiology, St Michael's Hospital, Division of Cardiology, Department of Medicine, Faculty of Medicine (B.L.A.), University of Toronto, Ontario, Canada.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Gray', 'Affiliation': ""Emergency Medicine and Critical Care, St Michael's Hospital, Division of Emergency Medicine, Department of Medicine, Interdepartmental Division of Critical Care, Faculty of Medicine (S.G.), University of Toronto, Ontario, Canada.""}, {'ForeName': 'Rob A', 'Initials': 'RA', 'LastName': 'Fowler', 'Affiliation': 'Sunnybrook Health Sciences Center, Interdepartmental Division of Critical Care Medicine, Faculty of Medicine, Institute for Health Policy and Management (R.A.F.), University of Toronto, Ontario, Canada.'}, {'ForeName': 'Katie N', 'Initials': 'KN', 'LastName': 'Dainty', 'Affiliation': 'North York General Hospital, Institute for Health Policy and Management (K.N.D.), University of Toronto, Ontario, Canada.'}, {'ForeName': 'Ahamed H', 'Initials': 'AH', 'LastName': 'Idris', 'Affiliation': 'Department of Emergency Medicine (A.H.I.), University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Morrison', 'Affiliation': ""Rescu at the Li Ka Shing Knowledge Institute, Emergency Medicine, St. Michael's Hospital, Division of Emergency Medicine, Department of Medicine, Faculty of Medicine, Institute for Health Policy and Management (L.M.), University of Toronto, Ontario, Canada.""}]",Circulation,['10.1161/CIRCULATIONAHA.120.050427'] 1702,33326064,Pharmacokinetic Interaction Between Telmisartan and Rosuvastatin/Ezetimibe After Multiple Oral Administration in Healthy Subjects.,"INTRODUCTION Telmisartan, rosuvastatin and ezetimibe are commonly recommended as combination therapies. However, the pharmacokinetic (PK) interaction among these therapeutic drugs has not been clearly reported. The objective of this study was to investigate possible interactions between telmisartan monotherapy and a fixed-dose combination (FDC) of rosuvastatin/ezetimibe. METHODS A randomized, open-label, multiple oral dose, three-treatment, three-period, six-sequence crossover study was conducted in healthy male volunteers. Monotherapy and cotherapy with telmisartan (80 mg) or a FDC of rosuvastatin and ezetimibe (20/10 mg) were compared after once-daily treatment for 7 days. The PK profiles for telmisartan, rosuvastatin, total ezetimibe (ezetimibe + exetimibe glucuronide) and ezetimibe were evaluated up to 48 h after the last dose. There was a 14-day washout period between each treatment. RESULTS The geometric mean ratios (GMRs) and 90% confidence intervals (CIs) for the peak plasma concentration at steady state (C max,ss ) and area under the plasma concentration-time curve during the dosing interval at steady state (AUC τ,ss ) were 1.258 (1.072-1.475) (P = 0.020) and 1.264 (1.167-1.370) (P < 0.001) for telmisartan, 0.796 (0.723-0.878) (P < 0.001) and 0.904 (0.842-0.970) (P = 0.021) for total ezetimibe and 1.237 (1.081-1.416) (P = 0.012) and 0.988 (0.899-1.086) (P = 0.832) for ezetimibe, respectively. With rosuvastatin, the GMR (90% CI) was 2.616 (2.287-2.992) (P < 0.001) for C max,ss and 1.265 (1.168-1.369) (P < 0.001) for AUC τ,ss . No serious adverse events or clinically significant results were reported. CONCLUSIONS The coadministration of multiple doses of telmisartan and rosuvastatin/ezetimibe led to a mild increase in systemic exposure with respect to telmisartan and rosuvastatin and a nonsignificant change in exposure to total ezetimibe and ezetimibe, which was not considered clinically significant without safety concerns. Furthermore, for the generalizability of the clinical effects, a large-scaled clinical study might be required in patients with hypertension and dyslipidemia. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov registry number: NCT03802526.",2021,"No serious adverse events or clinically significant results were reported. ","['Healthy Subjects', 'patients with hypertension and dyslipidemia', 'healthy male volunteers']","['Monotherapy and cotherapy with telmisartan', 'Telmisartan and Rosuvastatin/Ezetimibe', 'telmisartan, rosuvastatin, total ezetimibe (ezetimibe\u2009+\u2009exetimibe glucuronide) and ezetimibe', 'rosuvastatin', 'telmisartan', 'FDC of rosuvastatin and ezetimibe', 'telmisartan and rosuvastatin/ezetimibe', 'telmisartan and rosuvastatin', 'Telmisartan, rosuvastatin and ezetimibe', 'telmisartan monotherapy and a fixed-dose combination (FDC) of rosuvastatin/ezetimibe']","['Pharmacokinetic Interaction', 'serious adverse events', 'pharmacokinetic (PK) interaction', 'systemic exposure', 'geometric mean ratios (GMRs) and 90% confidence intervals (CIs) for the peak plasma concentration at steady state (C max,ss ) and area under the plasma concentration-time curve']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0033972', 'cui_str': 'Combined therapy'}, {'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0752086', 'cui_str': 'Glucuronides'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3700394', 'cui_str': 'rosuvastatin and ezetimibe'}]","[{'cui': 'C1868980', 'cui_str': 'Pharmacokinetic interaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",,0.023831,"No serious adverse events or clinically significant results were reported. ","[{'ForeName': 'Chang Hee', 'Initials': 'CH', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, Gil Medical Center, Gachon University College of Medicine, Incheon, South Korea.'}, {'ForeName': 'Sol Ip', 'Initials': 'SI', 'LastName': 'Kang', 'Affiliation': 'Clinical Development, Navipharm Co., Ltd., Suwon, South Korea.'}, {'ForeName': 'Dongseong', 'Initials': 'D', 'LastName': 'Shin', 'Affiliation': 'Department of Pharmacology, Gachon University College of Medicine, Incheon, South Korea. dsshin@gilhospital.com.'}]",Advances in therapy,['10.1007/s12325-020-01592-8'] 1703,33328057,Electronic decision support and diarrhoeal disease guideline adherence (mHDM): a cluster randomised controlled trial.,"BACKGROUND Acute diarrhoeal disease management often requires rehydration alone without antibiotics. However, non-indicated antibiotics are frequently ordered and this is an important driver of antimicrobial resistance. The mHealth Diarrhoea Management (mHDM) trial aimed to establish whether electronic decision support improves rehydration and antibiotic guideline adherence in resource-limited settings. METHODS A cluster randomised controlled trial was done at ten district hospitals in Bangladesh. Inclusion criteria were patients aged 2 months or older with uncomplicated acute diarrhoea. Admission orders were observed without intervention in the pre-intervention period, followed by randomisation to electronic (rehydration calculator) or paper formatted WHO guidelines for the intervention period. The primary outcome was rate of intravenous fluid ordered as a binary variable. Generalised linear mixed-effect models, accounting for hospital clustering, served as the analytical framework; the analysis was intention to treat. The trial is registered with ClinicalTrials.gov (NCT03154229) and is completed. FINDINGS From March 11 to Sept 10, 2018, 4975 patients (75·6%) of 6577 screened patients were enrolled. The intervention effect for the primary outcome showed no significant differences in rates of intravenous fluids ordered as a function of decision-support type. Intravenous fluid orders decreased by 0·9 percentage points for paper electronic decision support and 4·2 percentage points for electronic decision support, with a 4·2-point difference between decision-support types in the intervention period (paper 98·7% [95% CI 91·8-99·8] vs electronic 94·5% [72·2-99·1]; p interaction =0·31). Adverse events such as complications and mortality events were uncommon and could not be statistically estimated. INTERPRETATION Although intravenous fluid orders did not change, electronic decision support was associated with increases in the volume of intravenous fluid ordered and decreases in antibiotics ordered, which are consistent with WHO guidelines. FUNDING US National Institutes of Health.",2020,"Although intravenous fluid orders did not change, electronic decision support was associated with increases in the volume of intravenous fluid ordered and decreases in antibiotics ordered, which are consistent with WHO guidelines. ","['ten district hospitals in Bangladesh', 'Inclusion criteria were patients aged 2 months or older with uncomplicated acute diarrhoea', '4975 patients (75·6%) of 6577 screened patients were enrolled']",[],"['rates of intravenous fluids ordered as a function of decision-support type', 'rate of intravenous fluid ordered as a binary variable', 'complications and mortality events']","[{'cui': 'C0020006', 'cui_str': 'District hospital'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]",[],"[{'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",6577.0,0.272591,"Although intravenous fluid orders did not change, electronic decision support was associated with increases in the volume of intravenous fluid ordered and decreases in antibiotics ordered, which are consistent with WHO guidelines. ","[{'ForeName': 'Ashraful I', 'Initials': 'AI', 'LastName': 'Khan', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Jasmine A', 'Initials': 'JA', 'LastName': 'Mack', 'Affiliation': 'Department of Health Outcomes and Biomedical Informatics, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Salimuzzaman', 'Affiliation': 'Institute of Epidemiology, Disease Control and Research, Ministry of Health and Family Welfare, Government of Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Mazharul I', 'Initials': 'MI', 'LastName': 'Zion', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Hasnat', 'Initials': 'H', 'LastName': 'Sujon', 'Affiliation': 'Institute of Epidemiology, Disease Control and Research, Ministry of Health and Family Welfare, Government of Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Ball', 'Affiliation': 'Quantitative Sciences Unit, Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Stace', 'Initials': 'S', 'LastName': 'Maples', 'Affiliation': 'Geospatial Center, Stanford University Libraries, Stanford, CA, USA.'}, {'ForeName': 'Md Mahbubur', 'Initials': 'MM', 'LastName': 'Rashid', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Mohammod J', 'Initials': 'MJ', 'LastName': 'Chisti', 'Affiliation': 'Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Shafiqul A', 'Initials': 'SA', 'LastName': 'Sarker', 'Affiliation': 'Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Debashish', 'Initials': 'D', 'LastName': 'Biswas', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Raduan', 'Initials': 'R', 'LastName': 'Hossin', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Bardosh', 'Affiliation': 'Department of Anthropology, University of Florida, Gainesville, FL, USA; Department of Environmental and Occupational Health Sciences, School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Yasmin A', 'Initials': 'YA', 'LastName': 'Begum', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Azimuddin', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Dane', 'Initials': 'D', 'LastName': 'Pieri', 'Affiliation': 'Independent Technology Developer, San Francisco, CA, USA.'}, {'ForeName': 'Farhana', 'Initials': 'F', 'LastName': 'Haque', 'Affiliation': 'Institute of Epidemiology, Disease Control and Research, Ministry of Health and Family Welfare, Government of Bangladesh, Dhaka, Bangladesh; Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Mahmudur', 'Initials': 'M', 'LastName': 'Rahman', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh; Institute of Epidemiology, Disease Control and Research, Ministry of Health and Family Welfare, Government of Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Adam C', 'Initials': 'AC', 'LastName': 'Levine', 'Affiliation': 'Department of Emergency Medicine, Brown University, Providence, RI, USA.'}, {'ForeName': 'Firdausi', 'Initials': 'F', 'LastName': 'Qadri', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Meerjady S', 'Initials': 'MS', 'LastName': 'Flora', 'Affiliation': 'Institute of Epidemiology, Disease Control and Research, Ministry of Health and Family Welfare, Government of Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Gurka', 'Affiliation': 'Department of Health Outcomes and Biomedical Informatics, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Nelson', 'Affiliation': 'Department of Pediatrics, University of Florida, Gainesville, FL, USA; Department of Environmental and Global Health, University of Florida, Gainesville, FL, USA; Emerging Pathogens Institute, University of Florida, Gainesville, FL, USA; Department of Pediatrics, Stanford University School of Medicine, Stanford University, Stanford, CA, USA. Electronic address: USAeric.nelson@ufl.edu.'}]",The Lancet. Digital health,['10.1016/S2589-7500(20)30062-5'] 1704,33331963,[Empowerment for our patients : Innovation in everyday urology].,"Patient empowerment includes measures that promote their autonomy and self-determination in the physician-patient relationship. In addition to successful medical treatment, goals include long-term treatment satisfaction and the best possible quality of life for the patients and their social environment. Various initiatives and projects from German urology are already used to empower our patients. Entscheidungshilfe Prostatakrebs (decision aid for prostate cancer) and the German language decision aid for advanced bladder cancer and for the choice of urinary diversion are implemented under the umbrella of the PatientenAkademie (patient academy) of German Urologists. With more than 12,000 users, Entscheidungshilfe Prostatakrebs is very well established in urological care in Germany. The randomized evaluation study with planned 1200 participants is close to the successful completion of recruitment. Another project from the German urology sector is the project ""antiCoagulation Help App for SurgERy"" (CHASER). The aim is to develop a smartphone-based decision aid for the perioperative management of patients undergoing antithrombotic therapy. Online support groups can also contribute to empowerment and have been analyzed systematically for prostate cancer patients. A large randomized study on this topic is currently in preparation. Continuing advances in digitalization can thus provide us with useful support in order to provide individual information to our patients. The German Urological Association and its PatientenAkademie have been committed to this for many years.",2021,The aim is to develop a smartphone-based decision aid for the perioperative management of patients undergoing antithrombotic therapy.,"['advanced bladder cancer', 'patients undergoing antithrombotic therapy', 'prostate cancer patients']",[],[],"[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]",[],[],,0.0247232,The aim is to develop a smartphone-based decision aid for the perioperative management of patients undergoing antithrombotic therapy.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Huber', 'Affiliation': 'Klinik und Poliklinik für Urologie, Medizinische Fakultät Carl Gustav Carus, TU Dresden, Fetscherstraße\xa074, 01307, Dresden, Deutschland. johannes.huber@uniklinikum-dresden.de.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Karschuck', 'Affiliation': 'Klinik und Poliklinik für Urologie, Medizinische Fakultät Carl Gustav Carus, TU Dresden, Fetscherstraße\xa074, 01307, Dresden, Deutschland.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Groeben', 'Affiliation': 'Klinik und Poliklinik für Urologie, Medizinische Fakultät Carl Gustav Carus, TU Dresden, Fetscherstraße\xa074, 01307, Dresden, Deutschland.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Thomas', 'Affiliation': 'Klinik und Poliklinik für Urologie, Medizinische Fakultät Carl Gustav Carus, TU Dresden, Fetscherstraße\xa074, 01307, Dresden, Deutschland.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Praus', 'Affiliation': 'Medizinische Fakultät, Klinik für Urologie, Universitätsklinikum Freiburg, Hugstetterstr.\xa055, 79106, Freiburg, Deutschland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Miernik', 'Affiliation': 'Medizinische Fakultät, Klinik für Urologie, Universitätsklinikum Freiburg, Hugstetterstr.\xa055, 79106, Freiburg, Deutschland.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gratzke', 'Affiliation': 'Medizinische Fakultät, Klinik für Urologie, Universitätsklinikum Freiburg, Hugstetterstr.\xa055, 79106, Freiburg, Deutschland.'}, {'ForeName': 'Georg W', 'Initials': 'GW', 'LastName': 'Alpers', 'Affiliation': 'Lehrstuhl für Klinische Psychologie und Biologische Psychologie und Psychotherapie, Fakultät für Sozialwissenschaften, Universität Mannheim, Mannheim, Deutschland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kriegmair', 'Affiliation': 'Klinik für Urologie und Urochirurgie, Universitätsmedizin Mannheim, Theodor-Kutzer-Ufer 1-3, 68161, Mannheim, Deutschland.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Michel', 'Affiliation': 'Klinik für Urologie und Urochirurgie, Universitätsmedizin Mannheim, Theodor-Kutzer-Ufer 1-3, 68161, Mannheim, Deutschland.'}]",Der Urologe. Ausg. A,['10.1007/s00120-020-01415-2'] 1705,33325010,Effects of inspiratory muscle training versus high intensity interval training on the recovery capacity after a maximal dynamic apnoea in breath-hold divers. A randomised crossover trial.,"INTRODUCTION After a maximal apnoea, breath-hold divers must restore O 2 levels and clear CO 2 and lactic acid produced. High intensity interval training (HIIT) and inspiratory muscle training (IMT) could be employed with the aim of increasing recovery capacity. This study aimed to evaluate the relative effects of IMT versus HIIT on recovery of peripheral oxygen saturation (SpO 2 ), and also on pulmonary function, inspiratory muscle strength, lactate and heart rate recovery after a maximal dynamic apnoea in breath-hold divers. METHODS Fifteen breath-hold divers performed two training interventions (IMT and HIIT) for 20 min, three days per week over four weeks in randomised order with a two week washout period. RESULTS IMT produced a > 3 s reduction in SpO 2 recovery time compared to HIIT. The forced expiratory volume in the first second (FEV 1 ) and maximum inspiratory pressure (MIP) were significantly increased in the IMT group compared to HIIT. The magnitude of these differences in favour of IMT was large in both cases. Neither training intervention was superior to the other for heart rate recovery time, nor in peak- and recovery- lactate. CONCLUSIONS IMT produced a reduction in SpO 2 recovery time compared to HIIT after maximal dynamic apnoea. Even a 3 s improvement in recovery could be important in scenarios like underwater hockey where repetitive apnoeas during high levels of exercise are separated by only seconds. IMT also improved FEV 1 and MIP, but no differences in lactate and heart rate recovery were found post-apnoea between HIIT and IMT.",2020,"IMT also improved FEV 1 and MIP, but no differences in lactate and heart rate recovery were found post-apnoea between HIIT and IMT.",['Fifteen breath-hold divers performed two'],"['High intensity interval training (HIIT) and inspiratory muscle training (IMT', 'IMT versus HIIT', 'IMT', 'inspiratory muscle training versus high intensity interval training', 'training interventions (IMT and HIIT']","['forced expiratory volume in the first second (FEV 1 ) and maximum inspiratory pressure (MIP', 'pulmonary function, inspiratory muscle strength, lactate and heart rate recovery', 'lactate and heart rate recovery']","[{'cui': 'C0235744', 'cui_str': 'Interrupted breathing'}, {'cui': 'C0403082', 'cui_str': 'Diver'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0334121', 'cui_str': 'Inflammatory myofibroblastic tumor'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0232021', 'cui_str': 'Peak inspiratory pressure'}, {'cui': 'C0376579', 'cui_str': 'Macrophage Inflammatory Proteins'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",,0.0295207,"IMT also improved FEV 1 and MIP, but no differences in lactate and heart rate recovery were found post-apnoea between HIIT and IMT.","[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'de Asís-Fernández', 'Affiliation': 'Departamento de Fisioterapia, Facultad de Ciencias de la Salud. Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Spain.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Del Corral', 'Affiliation': 'Departamento de Fisioterapia, Facultad de Ciencias de la Salud. Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Spain.'}, {'ForeName': 'Ibai', 'Initials': 'I', 'LastName': 'López-de-Uralde-Villanueva', 'Affiliation': 'Department of Radiology, Rehabilitation and Physiotherapy, Faculty of Nursing, Physiotherapy and Podiatry, Complutense University of Madrid, Spain.'}]",Diving and hyperbaric medicine,['10.28920/dhm50.4.318-324'] 1706,33332567,Pulmonary Metastasectomy in Colorectal Cancer: has the randomized controlled trial brought enough reliable evidence to convince believers in metastasectomy to reconsider their oncological practice?,,2021,,['Colorectal Cancer'],[],[],"[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]",[],[],,0.0592178,,"[{'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Van Raemdonck', 'Affiliation': 'Department of Thoracic Surgery, University Hospitals Leuven and KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Treasure', 'Affiliation': 'Clinical Operational Research Unit, Department of Mathematics and Physical Sciences, University College London, London, UK.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'Department of Gastrointestinal and Liver Diseases, Digestive Oncology Unit, University Hospitals Leuven and KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Fergus', 'Initials': 'F', 'LastName': 'Macbeth', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}]",European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery,['10.1093/ejcts/ezaa450'] 1707,33336844,FOLFOXIRI-Bevacizumab or FOLFOX-Panitumumab in Patients with Left-Sided RAS/BRAF Wild-Type Metastatic Colorectal Cancer: A Propensity Score-Based Analysis.,"BACKGROUND Doublets plus anti-epidermal growth factor receptors (EGFRs) are the preferred upfront option for patients with left-sided RAS/BRAF wild-type metastatic colorectal cancer (mCRC). Initial therapy with FOLFOXIRI-bevacizumab is superior to doublets plus bevacizumab independently from primary tumor sidedness and RAS/BRAF status. No randomized comparison between FOLFOXIRI-bevacizumab versus doublets plus anti-EGFRs is available in left-sided RAS/BRAF wild-type mCRC. MATERIALS AND METHODS We selected patients with left-sided RAS and BRAF wild-type mCRC treated with first-line FOLFOX-panitumumab or FOLFOXIRI-bevacizumab in five randomized trials: Valentino, TRIBE, TRIBE2, STEAM, and CHARTA. A propensity score-based analysis was performed to compare FOLFOXIRI-bevacizumab with FOLFOX-panitumumab. RESULTS A total of 185 patients received FOLFOX-panitumumab and 132 received FOLFOXIRI-bevacizumab. Median progression-free survival (PFS) and median overall survival (OS) were 13.3 and 33.1 months in the FOLFOXIRI-bevacizumab group compared with 11.4 and 30.3 months in the FOLFOX-panitumumab group (propensity score-adjusted hazard ratio (HR) for PFS, 0.82; 95% confidence interval (CI), 0.64-1.04; p = .11; propensity score-adjusted HR for OS, 0.80; 95% CI, 0.59-1.08; p = .14). No significant differences in overall response rate and disease control rate were observed. A statistically nonsignificant difference in favor of FOLFOXIRI-bevacizumab was observed for OS after secondary resection of metastases. Chemotherapy-related adverse events were more frequent in the FOLFOXIRI-bevacizumab group, with specific regard to grade 3 and 4 neutropenia (48% vs. 26%, adjusted p = .001). CONCLUSION Although randomized comparison is lacking, both FOLFOXIRI-bevacizumab and FOLFOX-panitumumab are valuable treatment options in left-sided RAS/BRAF wild-type mCRC. IMPLICATIONS FOR PRACTICE A propensity score-based analysis of five trials was performed to compare FOLFOX-panitumumab versus FOLFOXIRI-bevacizumab in left-sided RAS/BRAF wild-type metastatic colorectal cancer (mCRC). No significant differences were observed, but FOLFOXIRI-bevacizumab achieved numerically superior survival outcomes versus FOLFOX-panitumumab. Chemotherapy-related adverse events were more frequent in the FOLFOXIRI-bevacizumab group. These observations suggest that although doublet chemotherapy plus anti-EGFRs remains the preferred treatment in patients with left-sided RAS/BRAF wild-type mCRC, FOLFOXIRI-bevacizumab is a valuable option able to provide similar, if not better, outcomes at the price of a moderate increase in toxicity and may be adopted based on patients' preference and potential impact on quality of life.",2021,A statistically non-significant difference in favor of FOLFOXIRI-bevacizumab was observed for OS after secondary resection of metastases.,"['patients with left-sided RAS/BRAF wild-type metastatic colorectal cancer (mCRC', 'We selected patients with left-sided RAS and BRAF wild-type mCRC treated with', 'metastatic colorectal cancer patients']","['FOLFOXIRI-bevacizumab', 'FOLFOXIRI-bevacizumab or FOLFOX-panitumumab', 'first line FOLFOX-panitumumab or FOLFOXIRI-bevacizumab', 'FOLFOXIRI-bevacizumab with FOLFOX-panitumumab', 'bevacizumab', 'FOLFOX-panitumumab', 'FOLFOX-panitumumab vs FOLFOXIRI-bevacizumab', 'FOLFOXIRI-bevacizumab and FOLFOX-panitumumab']","['Chemotherapy-related adverse events', 'overall response rate and disease control rate', 'superior survival outcomes', 'adverse events', 'neutropenia', 'Median progression-free survival (PFS) and median overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",185.0,0.103669,A statistically non-significant difference in favor of FOLFOXIRI-bevacizumab was observed for OS after secondary resection of metastases.,"[{'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Pietrantonio', 'Affiliation': 'Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Fucà', 'Affiliation': 'Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Rossini', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Hans-Joachim', 'Initials': 'HJ', 'LastName': 'Schmoll', 'Affiliation': 'Klinik fur Innere Med IV, University Clinic Halle, Halle, Germany.'}, {'ForeName': 'Johanna C', 'Initials': 'JC', 'LastName': 'Bendell', 'Affiliation': 'GI Oncology, Sarah Cannon Research Institute, Nashville, Tennessee, USA.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Morano', 'Affiliation': 'Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Antoniotti', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Corallo', 'Affiliation': 'Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Borelli', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Raimondi', 'Affiliation': 'Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Marmorino', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Niger', 'Affiliation': 'Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Boccaccino', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Masi', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Unit of Medical Oncology 1, Department of Clinical and Experimental Oncology, Istituto Oncologico Veneto, IRCCS, Padua, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Boni', 'Affiliation': 'Clinical Epidemiology Unit, IRCCS Ospedale Policlinico San Martino, Genova, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'de Braud', 'Affiliation': 'Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Di Bartolomeo', 'Affiliation': 'Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cremolini', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.'}]",The oncologist,['10.1002/onco.13642'] 1708,33340343,Pharmacokinetics and Bioequivalence of Cefprozil for Suspension and Granule Formulation in Healthy Chinese Volunteers: Two Single-Dose Crossover Studies.,"INTRODUCTION Cefprozil, an oral second-generation semi-synthetic cephalosporin, possesses a broad spectrum of antimicrobial activity. A granule formulation has been developed to improve medication adherence of the patients. This study was conducted to assess the bioequivalence of the granule formulation to a dry suspension in healthy Chinese volunteers and estimate the pharmacokinetic (PK) profiles of cefprozil. METHODS An open-label, randomized, single-dose, two-period, two-group, crossover study was conducted in 60 healthy Chinese volunteers under fasted or fed conditions (30 volunteers for each condition) to assess the bioequivalence between two formulations of cefprozil. Blood samples were collected at specified time intervals, and the plasma concentrations of cis- and trans-cefprozil were determined by a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. PK and bioavailability parameters were estimated via non-compartmental methods. Adverse events (AEs) were also recorded. RESULTS Under fasted conditions, the mean C max was (3534.70 ± 634.67) ng/ml, T max was (0.98 ± 0.25) h, t 1/2 was (1.37 ± 0.13) h and AUC 0-t was (9302.86 ± 1618.39) ng·h/ml, respectively, after a single dose of 125 mg cefprozil for suspension. Under fed conditions, the mean C max was (2438.80 ± 493.78) ng/ml, T max was (1.66 ± 0.76) h, t 1/2 was (1.36 ± 0.24) h and AUC 0-t was (9332.36 ± 1373.61) ng·h/ml, respectively. The PK parameters of the granule formulation of cefprozil were similar to those of the suspension. The 90% CI values of the GMRs of C max, AUC 0-t and AUC 0-∞ under both fasted and fed conditions were within the prespecified bioequivalence range (80.00-125.00%). CONCLUSIONS According to the criteria for bioequivalence, the test granule formulations of cefprozil and ""Cefprozil for Suspension ® "" were determined to be bioequivalent whether under fasted or fed conditions by measurement of cis-, trans- and total cefprozil. TRIAL REGISTRATION ClinicalTrials.gov identifier, NCT04414254.",2021,"Under fed conditions, the mean C max was (2438.80 ± 493.78) ng/ml, T max was (1.66 ± 0.76)","['healthy Chinese volunteers', '60 healthy Chinese volunteers under fasted or fed conditions (30 volunteers for each condition', 'Healthy Chinese Volunteers']","['Cefprozil', 'cefprozil and ""Cefprozil', 'Cefprozil for Suspension and Granule Formulation', 'cefprozil']","['Adverse events (AEs', 'PK and bioavailability parameters', 'plasma concentrations of cis- and trans-cefprozil', 'medication adherence', 'GMRs of C max, AUC 0-t and AUC 0-∞ under both fasted and fed conditions']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0053882', 'cui_str': 'cefprozil'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0007099', 'cui_str': 'Carcinoma in situ'}, {'cui': 'C0053882', 'cui_str': 'cefprozil'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",60.0,0.0496548,"Under fed conditions, the mean C max was (2438.80 ± 493.78) ng/ml, T max was (1.66 ± 0.76)","[{'ForeName': 'Ping-Ping', 'Initials': 'PP', 'LastName': 'Lin', 'Affiliation': 'Clinical Trial Center, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Chen-Jing', 'Initials': 'CJ', 'LastName': 'Wang', 'Affiliation': 'Clinical Trial Center, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Yan-Ping', 'Initials': 'YP', 'LastName': 'Liu', 'Affiliation': 'Clinical Trial Center, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Clinical Trial Center, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Xiao-Meng', 'Initials': 'XM', 'LastName': 'Gao', 'Affiliation': 'Clinical Trial Center, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Ya-Ping', 'Initials': 'YP', 'LastName': 'Ma', 'Affiliation': 'Clinical Trial Center, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Shi', 'Affiliation': 'Clinical Trial Center, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Clinical Trial Center, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Le-Xin', 'Initials': 'LX', 'LastName': 'Wang', 'Affiliation': 'School of Biomedical Sciences, Charles Sturt University, Wagga Wagga, NSW, Australia. lwang@csu.edu.au.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Clinical Trial Center, The Affiliated Hospital of Qingdao University, Qingdao, China. caoyu1767@126.com.'}]",Advances in therapy,['10.1007/s12325-020-01593-7'] 1709,33342710,"Tolerability of lacosamide rapid dose titration: A randomized, multicenter, prospective, open-label study.","OBJECTIVE Currently recommended dosing of lacosamide often necessitates long titration periods. However, the use of a regimen consisting of initial loading dose of 200 mg followed by a maintenance dose of 200 mg/day in practice suggests tolerability of more rapid titration schedules. We aimed to clarify whether the shortened titration schedule affects tolerability of lacosamide. METHODS We evaluated the safety of two rapid titration protocols designed to reach the target dose of 400 mg/day within 1 week, and the conventional weekly titration protocol (reaching the target dose of 400 mg/day in three weeks). The ≥50% responder rate and steady-state plasma concentration of lacosamide were also analyzed. Adverse events were assessed at 1 week and 5 weeks after reaching the target dose. RESULTS Seventy-five patients with epilepsy were enrolled and evenly distributed to three titration protocols, from which 5 patients were lost to follow-up and excluded from the safety analysis. Discontinuation of lacosamide or dose reductions due to adverse events occurred in 32 patients (46%), of whom a large majority (74%) had experienced adverse events after reaching 400 mg/day, demonstrating apparent dose-dependency. There was no difference in safety outcomes among the three titration groups. Concomitant use of sodium channel blockers significantly increased the risk of adverse events. CONCLUSION Rapid titration protocols for lacosamide were not associated with an increased risk of adverse events compared to the conventional weekly titration protocol. Uptitration of lacosamide at shorter intervals to an effective target dosage may be feasible in appropriate clinical situations.",2021,"CONCLUSION Rapid titration protocols for lacosamide were not associated with an increased risk of adverse events compared to the conventional weekly titration protocol.",['Seventy-five patients with epilepsy'],"['lacosamide', 'sodium channel blockers', 'lacosamide rapid dose titration']","['responder rate and steady-state plasma concentration of lacosamide', 'Tolerability', 'Adverse events', 'safety outcomes', 'adverse events', 'risk of adverse events']","[{'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}]","[{'cui': 'C0893761', 'cui_str': 'lacosamide'}, {'cui': 'C0872271', 'cui_str': 'Sodium channel blocker'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}]","[{'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0893761', 'cui_str': 'lacosamide'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",5.0,0.0525716,"CONCLUSION Rapid titration protocols for lacosamide were not associated with an increased risk of adverse events compared to the conventional weekly titration protocol.","[{'ForeName': 'Yong-Won', 'Initials': 'YW', 'LastName': 'Shin', 'Affiliation': 'Center for Hospital Medicine, Department of Neurosurgery, Seoul National University Hospital, Seoul, Republic of Korea; Department of Neurology, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Jangsup', 'Initials': 'J', 'LastName': 'Moon', 'Affiliation': 'Department of Neurology, Seoul National University Hospital, Seoul, Republic of Korea; Rare Disease Center, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Yong Won', 'Initials': 'YW', 'LastName': 'Cho', 'Affiliation': 'Department of Neurology, Keimyung University Dongsan Medical Center, Daegu, Republic of Korea.'}, {'ForeName': 'Dong Wook', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Konkuk University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sang Bin', 'Initials': 'SB', 'LastName': 'Hong', 'Affiliation': 'Department of Neurology, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Do-Yong', 'Initials': 'DY', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Hyeyeon', 'Initials': 'H', 'LastName': 'Chang', 'Affiliation': 'Department of Neurology, Konyang University Hospital, Daejeon, Republic of Korea.'}, {'ForeName': 'Seo Hyun', 'Initials': 'SH', 'LastName': 'Yoon', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Kyung-Sang', 'Initials': 'KS', 'LastName': 'Yu', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'In-Jin', 'Initials': 'IJ', 'LastName': 'Jang', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Soon-Tae', 'Initials': 'ST', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Keun-Hwa', 'Initials': 'KH', 'LastName': 'Jung', 'Affiliation': 'Department of Neurology, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Kyung-Il', 'Initials': 'KI', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Seoul National University Hospital, Seoul, Republic of Korea; Seoul National University Hospital Healthcare System Gangnam Center, Seoul, Republic of Korea.'}, {'ForeName': 'Ki-Young', 'Initials': 'KY', 'LastName': 'Jung', 'Affiliation': 'Department of Neurology, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Manho', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Seoul National University Hospital, Seoul, Republic of Korea; Protein Metabolism and Dementia Neuroscience Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kon', 'Initials': 'K', 'LastName': 'Chu', 'Affiliation': 'Department of Neurology, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'SeungHwan', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University Hospital, Seoul, Republic of Korea. Electronic address: leejh413@snu.ac.kr.'}, {'ForeName': 'Sang Kun', 'Initials': 'SK', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Seoul National University Hospital, Seoul, Republic of Korea. Electronic address: sangkun2923@gmail.com.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107663'] 1710,29847531,Comparing Acceleration and Change of Direction Ability Between Backpedal and Cross-over Run Techniques for Use in American Football.,"ABSTRACT Angelino, D, McCabe, TJG, and Earp, JE. Comparing acceleration and change of direction ability between backpedal and cross-over run techniques for use in American football. J Strength Cond Res 35(1): 47-55, 2021-In American football, defensive backs guard receivers using either cross-over (CO) run or backpedal (BP) techniques, but the efficacy of these techniques is unknown. The purpose of this study was to compare linear acceleration (LA) and change of direction (CoD) ability when using CO and BP. Collegiate football defensive backs participated in LA (n = 13) and CoD (n = 7) testing. During LA, subjects performed CO, BP, and forward sprints with split times taken between 0-3 and 3-5 yd and ground reaction forces recorded 0 and 3 yd from the start. During CoD testing, subjects performed the CO or BP for 3 yd and then were given a cue to sprint to a gate 5 yd away in 1 of 4 directions (downfield, midfield, sideline, or upfield). In LA, CO was faster than BP between 0-3 yd (Δ -0.20 ± 0.02 seconds, p = 0.000) and 3-5 yd (Δ -0.12 ± 0.02 seconds, p = 0.000). At the start of the movement, CO demonstrated greater propulsive forces (p = 0.017). However, 3 yd from the start, CO demonstrated greater propulsive forces and reduced braking forces (p = 0.000 & 0.003). In CoD, CO was faster than BP when running in the downfield (Δ 0.21 ± 0.05 seconds, p = 0.044) and lateral directions (Δ 0.21 ± 0.08 seconds, p = 0.035), but similar in the upfield direction (Δ 0.01 ± 0.08, p = 0.986). Our results indicate that CO is superior to BP in LA, CoD ability, and movement efficiency and support the use of CO for defensive backs.",2021,"However, 3 yd from the start, CO demonstrated greater propulsive forces and reduced braking forces (p = 0.000 & 0.003).",['Collegiate football defensive backs participated in LA (n = 13) and CoD (n = 7) testing'],"['cross-over (CO) run or backpedal (BP) techniques', 'CO']","['propulsive forces and reduced braking forces', 'propulsive forces', 'lateral directions', 'linear acceleration (LA) and change of direction ']","[{'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0004600', 'cui_str': 'Back'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C3653283', 'cui_str': 'PROPULSIVES'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0164318,"However, 3 yd from the start, CO demonstrated greater propulsive forces and reduced braking forces (p = 0.000 & 0.003).","[{'ForeName': 'Domenic', 'Initials': 'D', 'LastName': 'Angelino', 'Affiliation': 'Department of Kinesiology, University of Rhode Island, Kingston, Rhode Island; and.'}, {'ForeName': 'Thomas J G', 'Initials': 'TJG', 'LastName': 'McCabe', 'Affiliation': 'Department of Movement Sciences, Westfield State University, Westfield, Massachusetts.'}, {'ForeName': 'Jacob E', 'Initials': 'JE', 'LastName': 'Earp', 'Affiliation': 'Department of Kinesiology, University of Rhode Island, Kingston, Rhode Island; and.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002626'] 1711,33351179,Achievement of Remission Endpoints with Secukinumab Over 3 Years in Active Ankylosing Spondylitis: Pooled Analysis of Two Phase 3 Studies.,"INTRODUCTION Clinical remission in patients with ankylosing spondylitis (AS) has been determined using composite indices such as the AS Disease Activity Score inactive disease (ASDAS-ID), Assessment of SpondyloArthritis international Society criteria partial remission (ASAS-PR), and low Bath AS Disease Activity Index (BASDAI) scores. The objective of this exploratory analysis was to evaluate the proportion of secukinumab-treated patients with AS achieving remission defined based on the ASDAS-ID (score < 1.3), ASAS-PR or BASDAI score ≤  2. METHODS The analysis pooled data from the MEASURE 1 and 2 studies over 3 years. The proportion of patients who achieved ASDAS-ID, ASAS-PR, or BASDAI ≤ 2 with secukinumab was compared with placebo at week 16; results for secukinumab-treated patients were summarized through week 156. Sustainability of each criterion was assessed from week 16 to 156 using shift analysis. The association between each of these criteria and specific patient-reported outcomes (PROs), such as health-related quality of life, function, fatigue, and work impairment, was also explored. RESULTS At week 16, a higher proportion of secukinumab-treated patients versus placebo achieved ASDAS-ID (17.6 vs. 3.5%), ASAS-PR (15.4 vs. 4.1%), or BASDAI ≤ 2 (22.3 vs. 6.4%) criteria (all P < 0.0001), which were sustained through 156 weeks. Shift analysis showed that the majority of secukinumab-treated patients achieving remission at week 16 maintained their status at week 156 (ASDAS-ID, 57.1%; ASAS-PR, 68.0% and BASDAI ≤ 2, 74.3%). Remission was also associated with improved PROs over 156 weeks. CONCLUSIONS Secukinumab-treated patients maintained ASDAS-ID, ASAS-PR, or BASDAI ≤ 2 from week 16 up to 3 years. Patients who achieved at least one of the three responses/states, reported improvement in PROs, which suggests an association of clinical remission/ID with PROs in patients with active AS. TRIAL REGISTRATION ClinicalTrials.gov: NCT01358175, NCT01863732, and NCT01649375.",2021,"Remission was also associated with improved PROs over 156 weeks. ","['patients with ankylosing spondylitis (AS', 'Active Ankylosing Spondylitis', 'proportion of secukinumab-treated patients with AS achieving remission defined based on the ASDAS-ID (score < 1.3), ASAS-PR or BASDAI score ≤\u2009 2']","['placebo', 'Secukinumab']","['low Bath AS Disease Activity Index (BASDAI) scores', 'ASDAS-ID', 'health-related quality of life, function, fatigue, and work impairment', 'ASAS-PR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0949690', 'cui_str': 'Arthritis of spine'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1998004', 'cui_str': 'Bath ankylosing spondylitis disease activity index'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0949690', 'cui_str': 'Arthritis of spine'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}]",,0.163984,"Remission was also associated with improved PROs over 156 weeks. ","[{'ForeName': 'Xenofon', 'Initials': 'X', 'LastName': 'Baraliakos', 'Affiliation': 'Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Bochum, Germany. xenofon.baraliakos@elisabethgruppe.de.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Van den Bosch', 'Affiliation': 'Department of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Pedro M', 'Initials': 'PM', 'LastName': 'Machado', 'Affiliation': 'Department of Rheumatology, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Lianne S', 'Initials': 'LS', 'LastName': 'Gensler', 'Affiliation': 'Department of Medicine/Rheumatology, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Marzo-Ortega', 'Affiliation': 'NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals Trust, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Bintu', 'Initials': 'B', 'LastName': 'Sherif', 'Affiliation': 'RTI Health Solutions, Research Triangle Park, NC, USA.'}, {'ForeName': 'Erhard', 'Initials': 'E', 'LastName': 'Quebe-Fehling', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Porter', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Corine', 'Initials': 'C', 'LastName': 'Gaillez', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Deodhar', 'Affiliation': 'Oregon Health and Science University, Portland, OR, USA.'}]",Rheumatology and therapy,['10.1007/s40744-020-00269-6'] 1712,33368393,Assessing the impact of an automated Web-based motivational interview on the intention and return behavior of Australian O-negative donors.,"BACKGROUND O-negative donors are a critical resource for blood collection agencies, and their recruitment and retention provides an ongoing challenge. Motivational interviewing shows promise as a tool to promote donor retention, although concerns about scalability remain. The current study examined the effect of an automated Web-based interview drawing on motivational interviewing and self-determination theory on O-negative donors' motivation, intention, and behavior. STUDY DESIGN AND METHODS Within 13 days of donating, 2820 O-negative donors completed baseline measures of motivation and intention before being randomly assigned to complete either a motivational interview (MI) or active control interview (ACI). Motivation and intention were assessed at 2 days and at 7 weeks after participation in the MI or ACI, with return behavior tracked for 6 months following trial completion. RESULTS Changes in donor motivation and intention, rate, and time to return did not vary by participation in the MI or ACI. When compared with O-negative donors who experienced business-as-usual practices, donors completing the MI or ACI returned to donate more, and they returned more quickly. However, subsequent exploratory analyses considering the behavior of those who did not accept the invitation to participate and those who completed only baseline measures showed that the improved return behavior of donors in the MI or ACI conditions was likely not due to any specific properties of the MI or ACI activities. CONCLUSIONS Australian O-negative donors were highly internally motivated and committed to donating. An automated Web-based motivational interview appears to be of limited effectiveness in promoting the return of such donors.",2021,"The current study examined the effect of an automated Web-based interview drawing on motivational interviewing and self-determination theory on O-negative donors' motivation, intention, and behavior. ","['Australian O-negative donors', 'Within 13\u2009days of donating, 2820 O-negative donors completed baseline measures of motivation and intention before being randomly assigned to complete either a']","['Motivational interviewing', 'automated Web-based motivational interview', 'automated Web-based interview drawing on motivational interviewing and self-determination theory', 'motivational interview (MI) or active control interview (ACI']","['donor motivation and intention, rate, and time to return', 'Motivation and intention']","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0036595', 'cui_str': 'Self Determination'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332156', 'cui_str': 'Return to'}]",,0.0232831,"The current study examined the effect of an automated Web-based interview drawing on motivational interviewing and self-determination theory on O-negative donors' motivation, intention, and behavior. ","[{'ForeName': 'Kyle S', 'Initials': 'KS', 'LastName': 'Jensen', 'Affiliation': 'Research and Development, Australian Red Cross Lifeblood, Kelvin Grove, Queensland, Australia.'}, {'ForeName': 'Barbara M', 'Initials': 'BM', 'LastName': 'Masser', 'Affiliation': 'Research and Development, Australian Red Cross Lifeblood, Kelvin Grove, Queensland, Australia.'}, {'ForeName': 'Tanya E', 'Initials': 'TE', 'LastName': 'Davison', 'Affiliation': 'Research and Development, Australian Red Cross Lifeblood, St Kilda, Victoria, Australia.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Van Dyke', 'Affiliation': 'Research and Development, Australian Red Cross Lifeblood, St Kilda, Victoria, Australia.'}, {'ForeName': 'Janis L', 'Initials': 'JL', 'LastName': 'France', 'Affiliation': 'Department of Psychology, Ohio University, Athens, Ohio, USA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'France', 'Affiliation': 'Department of Psychology, Ohio University, Athens, Ohio, USA.'}]",Transfusion,['10.1111/trf.16234'] 1713,33334164,Internet-delivered cognitive behaviour therapy for adolescents with insomnia comorbid to psychiatric conditions: A non-randomised trial.,"Insomnia is highly prevalent among adolescents with psychiatric conditions and is known to aggravate psychiatric symptoms. Research on cognitive behaviour therapy for adolescents with comorbid insomnia (CBT-I) is still limited. The aim of this study was to investigate feasibility and preliminary effects of internet-delivered CBT for adolescents with insomnia comorbid to a psychiatric condition. Twenty-one patients (13-17 years) with comorbid insomnia were recruited from Child and Adolescent Psychiatry. All patients received 7 weeks of internet-delivered CBT-I with therapist support. Outcomes were assessed at baseline, post-treatment, and at a 4-month follow-up. The proportion of completed assessments was overall acceptable. Participants on average completed 4.48 ( sd  = 1.97) of the seven treatment modules and therapists on average spent 12.80 minutes ( sd  = 6.23) per patient and week. Results showed large statistically significant improvements on insomnia severity, sleep efficiency, sleep onset latency and sleep quality. Medium to large improvements were also seen on the psychiatric symptoms of depression, obsessive-compulsive symptoms, interpersonal sensitivity, paranoid ideation and psychoticism. These findings indicate that internet-delivered CBT is feasible and potentially promising for improving sleep and reducing psychiatric symptoms in adolescent psychiatric patients with insomnia and co-morbid psychiatric disorders. A larger randomised trial is warranted to verify these preliminary results.",2021,"Medium to large improvements were also seen on the psychiatric symptoms of depression, obsessive-compulsive symptoms, interpersonal sensitivity, paranoid ideation and psychoticism.","['adolescents with comorbid insomnia (CBT-I', 'adolescents with insomnia comorbid to psychiatric conditions', 'Twenty-one patients (13-17\u2009years) with comorbid insomnia were recruited from Child and Adolescent Psychiatry', 'adolescents with psychiatric conditions', 'adolescents with insomnia comorbid to a psychiatric condition', 'adolescent psychiatric patients with insomnia and co-morbid psychiatric disorders']","['CBT', 'Internet-delivered cognitive behaviour therapy', 'cognitive behaviour therapy', 'CBT-I with therapist support', 'internet-delivered CBT']","['insomnia severity, sleep efficiency, sleep onset latency and sleep quality', 'psychiatric symptoms of depression, obsessive-compulsive symptoms, interpersonal sensitivity, paranoid ideation and psychoticism']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1274032', 'cui_str': 'Child and adolescent psychiatry'}, {'cui': 'C0748064', 'cui_str': 'Psychiatric in-patient'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4087290', 'cui_str': 'Obsessive-compulsive symptom'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0747249', 'cui_str': 'Paranoid ideation'}]",21.0,0.0702315,"Medium to large improvements were also seen on the psychiatric symptoms of depression, obsessive-compulsive symptoms, interpersonal sensitivity, paranoid ideation and psychoticism.","[{'ForeName': 'Vendela', 'Initials': 'V', 'LastName': 'Zetterqvist', 'Affiliation': 'Department of Neuroscience, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Lundén', 'Affiliation': 'Department of Neuroscience, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Herrmann', 'Affiliation': 'Child and Adolescent Psychiatric Services, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Hasbar', 'Affiliation': 'Child and Adolescent Psychiatric Services, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Najah', 'Initials': 'N', 'LastName': 'Khalifa', 'Affiliation': 'Centre for Research and Development, Uppsala University/Region Gävleborg, Uppsala, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Lekander', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Lie', 'Initials': 'L', 'LastName': 'Åslund', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Jernelöv', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}]",Clinical child psychology and psychiatry,['10.1177/1359104520978464'] 1714,33317805,A randomised pilot trial of combined cognitive and physical exercise prehabilitation to improve outcomes in surgical patients.,,2021,,['surgical patients'],['combined cognitive and physical exercise prehabilitation'],[],"[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C5192101', 'cui_str': 'Prehabilitation'}]",[],,0.0382007,,"[{'ForeName': 'Kimberly F', 'Initials': 'KF', 'LastName': 'Rengel', 'Affiliation': 'Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center, Vanderbilt University Medical Center, Nashville, TN, USA; Department of Anesthesiology, Division of Anesthesia Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN, USA. Electronic address: kimberly.rengel@vumc.org.'}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Mehdiratta', 'Affiliation': 'Department of Anesthesiology, Division of Anesthesia Critical Care and GVT, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Susan W', 'Initials': 'SW', 'LastName': 'Vanston', 'Affiliation': 'Department of Orthopedic Surgery, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Kristin R', 'Initials': 'KR', 'LastName': 'Archer', 'Affiliation': 'Department of Orthopedic Surgery, Vanderbilt University Medical Center, Nashville, TN, USA; Department of Physical Medicine and Rehabilitation, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Jackson', 'Affiliation': 'Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center, Vanderbilt University Medical Center, Nashville, TN, USA; The Center for Health Services Research, Vanderbilt University Medical Center, Nashville, TN, USA; Geriatric Research, Education and Clinical Center (GRECC) Service, Nashville Veterans Affairs Medical Center, Tennessee Valley Healthcare System, Nashville, TN, USA; Department of Psychiatry, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Thompson', 'Affiliation': 'Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center, Vanderbilt University Medical Center, Nashville, TN, USA; Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Pratik P', 'Initials': 'PP', 'LastName': 'Pandharipande', 'Affiliation': 'Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center, Vanderbilt University Medical Center, Nashville, TN, USA; Department of Anesthesiology, Division of Anesthesia Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; Nashville Veterans Affairs Medical Center, Tennessee Valley Healthcare System, Nashville, TN, USA.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Hughes', 'Affiliation': 'Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center, Vanderbilt University Medical Center, Nashville, TN, USA; Department of Anesthesiology, Division of Anesthesia Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; Nashville Veterans Affairs Medical Center, Tennessee Valley Healthcare System, Nashville, TN, USA.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.11.004'] 1715,33316649,Exploring brain insulin resistance in adults with bipolar depression using extracellular vesicles of neuronal origin.,"Accumulating evidence suggests that disrupted insulin signaling is involved in bipolar disorder (BD) pathogenesis. Herein, we aimed to directly explore the potential role of neuronal insulin signaling using an innovative technique based on biomarkers derived from plasma extracellular vesicles enriched for neuronal origin (NEVs). We leveraged plasma samples from a randomized, double-blind, placebo-controlled, 12-week clinical trial evaluating infliximab as a treatment of bipolar depression. We isolated NEVs using immunoprecipitation against neuronal marker L1CAM from samples collected at baseline and weeks 2, 6 and 12 (endpoint) and measured NEV biomarkers using immunoassays. We assessed neuronal insulin signaling at its first node (IRS-1) and along the canonical (Akt, GSK-3β, p70S6K) and alternative (ERK1/2, JNK and p38-MAPK) pathways. A subset of participants (n = 27) also underwent whole-brain magnetic resonance imaging (MRI) at baseline and endpoint. Pre-treatment, NEV biomarkers of insulin signaling were independently associated with cognitive function and MRI measures (i.e. hippocampal and ventromedial prefrontal cortex [vmPFC] volumes). In fact, the association between IRS-1 phosphorylation at serine site 312 (pS312-IRS-1), an indicator of insulin resistance, and cognitive dysfunction was mediated by vmPFC volume. In the longitudinal analysis, patients treated with infliximab, a tumor necrosis factor-alpha antagonist with known insulin sensitizing properties, compared to those treated with placebo, had augmented phosphorylation of proteins from the alternative pathway. Infliximab responders had significant increases in phosphorylated JNK levels, relative to infliximab non-responders and placebo responders. In addition, treatment with infliximab resulted in increase in MRI measures of brain volume; treatment-related changes in the dorsolateral prefrontal cortex volume were mediated by changes in biomarkers from the insulin alternative pathway. In conclusion, our findings support the idea that brain insulin signaling is a target for further mechanistic and therapeutic investigations.",2021,"Infliximab responders had significant increases in phosphorylated JNK levels, relative to infliximab non-responders and placebo responders.","['bipolar depression', 'adults with bipolar depression using extracellular vesicles of neuronal origin']","['infliximab', 'whole-brain magnetic resonance imaging (MRI', 'placebo', 'Infliximab']","['cognitive function and MRI measures', 'insulin resistance, and cognitive dysfunction', 'phosphorylated JNK levels', 'MRI measures of brain volume', 'dorsolateral prefrontal cortex volume']","[{'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3894683', 'cui_str': 'Extracellular Vesicles'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}]",,0.0843391,"Infliximab responders had significant increases in phosphorylated JNK levels, relative to infliximab non-responders and placebo responders.","[{'ForeName': 'Rodrigo B', 'Initials': 'RB', 'LastName': 'Mansur', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Francheska', 'Initials': 'F', 'LastName': 'Delgado-Peraza', 'Affiliation': 'Laboratory of Clinical Investigation, Intramural Research Program, National Institute on Aging, National Institutes of Health (NIA/NIH), Baltimore, MD, USA.'}, {'ForeName': 'Mehala', 'Initials': 'M', 'LastName': 'Subramaniapillai', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Yena', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Institute of Medical Science, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Iacobucci', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Nasri', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Rodrigues', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Rosenblat', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Brietzke', 'Affiliation': ""Kingston General Hospital, Providence Care Hospital, Department of Psychiatry, Queen's University School of Medicine, Kingston, ON, Canada.""}, {'ForeName': 'Victoria E', 'Initials': 'VE', 'LastName': 'Cosgrove', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University, School of Medicine, and Veterans Affairs Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Kramer', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University, School of Medicine, and Veterans Affairs Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Suppes', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University, School of Medicine, and Veterans Affairs Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Raison', 'Affiliation': 'School of Human Ecology, University of Wisconsin-Madison, Madison, WI, USA; Department of Psychiatry, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Fagiolini', 'Affiliation': 'Department of Molecular Medicine, University of Siena, Italy.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Rasgon', 'Affiliation': ""Center for Neuroscience in Women's Health, Stanford University, Palo Alto, USA.""}, {'ForeName': 'Sahil', 'Initials': 'S', 'LastName': 'Chawla', 'Affiliation': 'Laboratory of Clinical Investigation, Intramural Research Program, National Institute on Aging, National Institutes of Health (NIA/NIH), Baltimore, MD, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Nogueras-Ortiz', 'Affiliation': 'Laboratory of Clinical Investigation, Intramural Research Program, National Institute on Aging, National Institutes of Health (NIA/NIH), Baltimore, MD, USA.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Kapogiannis', 'Affiliation': 'Laboratory of Clinical Investigation, Intramural Research Program, National Institute on Aging, National Institutes of Health (NIA/NIH), Baltimore, MD, USA. Electronic address: kapogiannisd@mail.nih.gov.'}, {'ForeName': 'Roger S', 'Initials': 'RS', 'LastName': 'McIntyre', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Institute of Medical Science, University of Toronto, Toronto, ON, Canada.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.12.007'] 1716,33323833,Controlled Drinking Behaviors Among Korean American and Korean Male Workers.,"BACKGROUND A permissive drinking culture is one reason for the high level of alcohol consumption among Korean men. Despite shared experiences of the Korean drinking culture that often encourages social drinking, Korean American and Korean male workers may differ in their drinking behavior. This study examines the predictors of controlled drinking behavior and between these two groups. OBJECTIVES The purpose of this study was to examine and compare the predictors of controlled drinking behavior between Korean American and Korean male workers. METHODS A total of 282 male participants (141 Korean Americans and 141 Koreans) who engaged in social drinking were surveyed. Ajzen's theory of planned behavior was used to examine the predictors of controlled drinking behavior. Structural equation modeling was employed to test the theoretical model for each group, followed by multiple group analyses. RESULTS The majority of participants were college-educated and white-collar workers. Korean American workers had fewer heavy episodic drinking days in the past month than Korean workers. Model testing for each group revealed that subjective norms and perceived behavioral control predicted intentions of controlled drinking, but only perceived behavioral control was a significant predictor of controlled drinking behavior. Multiple group analyses indicated no difference between the two groups regarding the predictors of controlled drinking behaviors. DISCUSSION Programs to promote controlled drinking for Korean American and Korean male workers should incorporate strategies to increase perceived behavioral control, such as training on how to decline drinking. In addition, early education for healthy drinking culture with a strict drinking environment needs to be considered to improve controlled drinking behaviors.",2020,"Multiple group analyses indicated no difference between the two groups regarding the predictors of controlled drinking behaviors. ","['282 male participants (141 Korean Americans and 141 Koreans) who engaged in social drinking were surveyed', 'Korean American and Korean Male Workers', 'Korean American workers', 'participants were college-educated and white-collar workers', 'Korean men', 'Korean American and Korean male workers']",[],"['controlled drinking behaviors', 'heavy episodic drinking days']","[{'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0597921', 'cui_str': 'Korean Americans'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0175751', 'cui_str': 'Cervical collar'}, {'cui': 'C0025266', 'cui_str': 'Man'}]",[],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013124', 'cui_str': 'Drinking Behavior'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}]",282.0,0.0157635,"Multiple group analyses indicated no difference between the two groups regarding the predictors of controlled drinking behaviors. ","[{'ForeName': 'Younkyoung', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Chonnam National University College of Nursing, Gwangju City, Republic of Korea Florida State University College of Nursing, Tallahassee, FL University of California School of Nursing, San Francisco, CA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lowe', 'Affiliation': ''}, {'ForeName': 'OiSaeng', 'Initials': 'O', 'LastName': 'Hong', 'Affiliation': ''}]",Nursing research,['10.1097/NNR.0000000000000495'] 1717,33323529,"Safety and Efficacy of Poseltinib, Bruton's Tyrosine Kinase Inhibitor, in Patients With Rheumatoid Arthritis: A Randomized, Double-blind, Placebo-controlled, 2-part Phase II Study.","OBJECTIVE To evaluate the efficacy and safety of poseltinib (formerly LY3337641/HM71224), an irreversible covalent inhibitor of Bruton's tyrosine kinase in a 2-part, phase II trial (RAjuvenate; ClinicalTrials.gov: NCT02628028) in adults with active rheumatoid arthritis (RA). METHODS In Part A, 36 patients with mildly active RA were randomized 1:1:1:1 to oral poseltinib 5, 10, or 30 mg or placebo once daily for 4 weeks to assess safety and tolerability. No safety signals precluded moving to Part B, where 250 patients with moderate-to-severe RA were randomized 1:1:1:1 to oral poseltinib 5 mg (n = 63), 10 mg (n = 62), or 30 mg (n = 63), or placebo (n = 62) once daily for 12 weeks. Parts A and B permitted stable doses of background disease-modifying antirheumatic drugs. The primary endpoint in Part B was proportion of patients achieving 20% improvement in American College of Rheumatology criteria (ACR20) at Week 12. Logistic regression compared each poseltinib dose to placebo for primary and secondary endpoints. Nonresponder imputation was used for missing data. RESULTS After interim analysis showed low likelihood of demonstrating significant efficacy, the sponsor discontinued Part B of the study. One hundred and eighty-nine (76%) patients completed 12 weeks in Part B; 61 discontinued study treatment (27 [44%] due to study termination by sponsor). There was no statistically significant difference in ACR20 response between any dose of poseltinib and placebo at Week 12 ( P > 0.05 for all comparisons). Five serious adverse events occurred (n = 2, placebo; n = 3, 30 mg); there was 1 death due to a fall. CONCLUSION While no safety findings precluded continuation, the study was terminated after interim data demonstrated low likelihood of benefit in RA.",2020,There was no statistically significant difference in ACR20 response between any dose of poseltinib and placebo at Week 12 (p<0.05 for all comparisons).,"['250 patients with moderate-to-severe RA', '36 patients with mildly active RA', 'adults with active rheumatoid arthritis (RA', 'Patients With Rheumatoid Arthritis']","['Placebo', ""Poseltinib, Bruton's Tyrosine Kinase-Inhibitor"", 'oral poseltinib', 'placebo']","['ACR20 response', 'Five serious adverse events', 'safety/tolerability', 'Part B was proportion of patients achieving 20% improvement in American College of Rheumatology criteria (ACR20']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4521488', 'cui_str': 'Non-specific protein-tyrosine kinase inhibitor'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]",36.0,0.473467,There was no statistically significant difference in ACR20 response between any dose of poseltinib and placebo at Week 12 (p<0.05 for all comparisons).,"[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Genovese', 'Affiliation': 'This trial was funded by Eli Lilly and Company, under license from Hanmi. M.C. Genovese, MD, Division of Immunology and Rheumatology, Stanford University, Palo Alto, California, USA; A. Spindler, MD, Centro Medico Privado de Reumatologia, Tucumán, Argentina; A. Sagawa, MD, Sagawa Akira Rheumatology Clinic, Sapporo, Japan; W. Park, MD, PhD, Division of Rheumatology, IN-HA University, Incheon, Korea; A. Dudek, MD, PhD, AMED Medical Center, Warsaw, Poland; A. Kivitz MD, CPI, Altoona Center for Clinical Research, Duncansville, Pennsylvania, USA; J. Chao, MD, L. Chan, MS, J. Witcher, PhD, W. Barchuk, MD, A. Nirula, MD, PhD, Eli Lilly and Company, Indianapolis, Indiana, USA. MCG is currently an employee of Gilead Sciences Inc. and holds stock options; he reports personal fees and other fees from Eli Lilly and Company, during the conduct of the study; personal fees and other fees from AbbVie, Gilead, and other from Galapagos and Pfizer, outside the submitted work. A. Sagawa reports being a paid instructor for ONO Pharmaceutical, Eli Lilly Japan, K.K., Takeda, AYUMI Pharmaceutical, Kissei Pharmaceutical, Chugai Pharmaceutical, Asahi Kasei Pharma Corporation, and Janssen. WP reports consulting fees from Celltrion. AK reports being a shareholder of Pfizer, Sanofi, GlaxoSmithKline, Gilead Sciences Inc., Novartis; a paid consultant for AbbVie, Boehringer Ingelheim, Flexion, Janssen, Pfizer, Sanofi, Regeneron, SUN Pharma Advanced Research, Gilead Sciences Inc.; and on the speakers bureau of Celgene, Merck, Lilly, Novartis, Pfizer, Sanofi, Genzyme, Flexion, AbbVie. JC, LC, JW, and AN are employees and stockholders of Eli Lilly. WB was an employee of Eli Lilly at the time of this study and currently is an employee of Gilead Sciences, Inc. and owns Gilead stock. A. Spindler and AD report no conflicts of interest. Address correspondence to Dr. M.C. Genovese, James W. Raitt Professor of Medicine, Co-Chief, Division of Immunology and Rheumatology, Stanford University School of Medicine, 1000 Welch Road, Suite 203, Palo Alto, CA 94304, USA. Email: genovese@stanford.edu. Accepted for publication October 28, 2020.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Spindler', 'Affiliation': 'This trial was funded by Eli Lilly and Company, under license from Hanmi. M.C. Genovese, MD, Division of Immunology and Rheumatology, Stanford University, Palo Alto, California, USA; A. Spindler, MD, Centro Medico Privado de Reumatologia, Tucumán, Argentina; A. Sagawa, MD, Sagawa Akira Rheumatology Clinic, Sapporo, Japan; W. Park, MD, PhD, Division of Rheumatology, IN-HA University, Incheon, Korea; A. Dudek, MD, PhD, AMED Medical Center, Warsaw, Poland; A. Kivitz MD, CPI, Altoona Center for Clinical Research, Duncansville, Pennsylvania, USA; J. Chao, MD, L. Chan, MS, J. Witcher, PhD, W. Barchuk, MD, A. Nirula, MD, PhD, Eli Lilly and Company, Indianapolis, Indiana, USA. MCG is currently an employee of Gilead Sciences Inc. and holds stock options; he reports personal fees and other fees from Eli Lilly and Company, during the conduct of the study; personal fees and other fees from AbbVie, Gilead, and other from Galapagos and Pfizer, outside the submitted work. A. Sagawa reports being a paid instructor for ONO Pharmaceutical, Eli Lilly Japan, K.K., Takeda, AYUMI Pharmaceutical, Kissei Pharmaceutical, Chugai Pharmaceutical, Asahi Kasei Pharma Corporation, and Janssen. WP reports consulting fees from Celltrion. AK reports being a shareholder of Pfizer, Sanofi, GlaxoSmithKline, Gilead Sciences Inc., Novartis; a paid consultant for AbbVie, Boehringer Ingelheim, Flexion, Janssen, Pfizer, Sanofi, Regeneron, SUN Pharma Advanced Research, Gilead Sciences Inc.; and on the speakers bureau of Celgene, Merck, Lilly, Novartis, Pfizer, Sanofi, Genzyme, Flexion, AbbVie. JC, LC, JW, and AN are employees and stockholders of Eli Lilly. WB was an employee of Eli Lilly at the time of this study and currently is an employee of Gilead Sciences, Inc. and owns Gilead stock. A. Spindler and AD report no conflicts of interest. Address correspondence to Dr. M.C. Genovese, James W. Raitt Professor of Medicine, Co-Chief, Division of Immunology and Rheumatology, Stanford University School of Medicine, 1000 Welch Road, Suite 203, Palo Alto, CA 94304, USA. Email: genovese@stanford.edu. Accepted for publication October 28, 2020.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Sagawa', 'Affiliation': 'This trial was funded by Eli Lilly and Company, under license from Hanmi. M.C. Genovese, MD, Division of Immunology and Rheumatology, Stanford University, Palo Alto, California, USA; A. Spindler, MD, Centro Medico Privado de Reumatologia, Tucumán, Argentina; A. Sagawa, MD, Sagawa Akira Rheumatology Clinic, Sapporo, Japan; W. Park, MD, PhD, Division of Rheumatology, IN-HA University, Incheon, Korea; A. Dudek, MD, PhD, AMED Medical Center, Warsaw, Poland; A. Kivitz MD, CPI, Altoona Center for Clinical Research, Duncansville, Pennsylvania, USA; J. Chao, MD, L. Chan, MS, J. Witcher, PhD, W. Barchuk, MD, A. Nirula, MD, PhD, Eli Lilly and Company, Indianapolis, Indiana, USA. MCG is currently an employee of Gilead Sciences Inc. and holds stock options; he reports personal fees and other fees from Eli Lilly and Company, during the conduct of the study; personal fees and other fees from AbbVie, Gilead, and other from Galapagos and Pfizer, outside the submitted work. A. Sagawa reports being a paid instructor for ONO Pharmaceutical, Eli Lilly Japan, K.K., Takeda, AYUMI Pharmaceutical, Kissei Pharmaceutical, Chugai Pharmaceutical, Asahi Kasei Pharma Corporation, and Janssen. WP reports consulting fees from Celltrion. AK reports being a shareholder of Pfizer, Sanofi, GlaxoSmithKline, Gilead Sciences Inc., Novartis; a paid consultant for AbbVie, Boehringer Ingelheim, Flexion, Janssen, Pfizer, Sanofi, Regeneron, SUN Pharma Advanced Research, Gilead Sciences Inc.; and on the speakers bureau of Celgene, Merck, Lilly, Novartis, Pfizer, Sanofi, Genzyme, Flexion, AbbVie. JC, LC, JW, and AN are employees and stockholders of Eli Lilly. WB was an employee of Eli Lilly at the time of this study and currently is an employee of Gilead Sciences, Inc. and owns Gilead stock. A. Spindler and AD report no conflicts of interest. Address correspondence to Dr. M.C. Genovese, James W. Raitt Professor of Medicine, Co-Chief, Division of Immunology and Rheumatology, Stanford University School of Medicine, 1000 Welch Road, Suite 203, Palo Alto, CA 94304, USA. Email: genovese@stanford.edu. Accepted for publication October 28, 2020.'}, {'ForeName': 'Won', 'Initials': 'W', 'LastName': 'Park', 'Affiliation': 'This trial was funded by Eli Lilly and Company, under license from Hanmi. M.C. Genovese, MD, Division of Immunology and Rheumatology, Stanford University, Palo Alto, California, USA; A. Spindler, MD, Centro Medico Privado de Reumatologia, Tucumán, Argentina; A. Sagawa, MD, Sagawa Akira Rheumatology Clinic, Sapporo, Japan; W. Park, MD, PhD, Division of Rheumatology, IN-HA University, Incheon, Korea; A. Dudek, MD, PhD, AMED Medical Center, Warsaw, Poland; A. Kivitz MD, CPI, Altoona Center for Clinical Research, Duncansville, Pennsylvania, USA; J. Chao, MD, L. Chan, MS, J. Witcher, PhD, W. Barchuk, MD, A. Nirula, MD, PhD, Eli Lilly and Company, Indianapolis, Indiana, USA. MCG is currently an employee of Gilead Sciences Inc. and holds stock options; he reports personal fees and other fees from Eli Lilly and Company, during the conduct of the study; personal fees and other fees from AbbVie, Gilead, and other from Galapagos and Pfizer, outside the submitted work. A. Sagawa reports being a paid instructor for ONO Pharmaceutical, Eli Lilly Japan, K.K., Takeda, AYUMI Pharmaceutical, Kissei Pharmaceutical, Chugai Pharmaceutical, Asahi Kasei Pharma Corporation, and Janssen. WP reports consulting fees from Celltrion. AK reports being a shareholder of Pfizer, Sanofi, GlaxoSmithKline, Gilead Sciences Inc., Novartis; a paid consultant for AbbVie, Boehringer Ingelheim, Flexion, Janssen, Pfizer, Sanofi, Regeneron, SUN Pharma Advanced Research, Gilead Sciences Inc.; and on the speakers bureau of Celgene, Merck, Lilly, Novartis, Pfizer, Sanofi, Genzyme, Flexion, AbbVie. JC, LC, JW, and AN are employees and stockholders of Eli Lilly. WB was an employee of Eli Lilly at the time of this study and currently is an employee of Gilead Sciences, Inc. and owns Gilead stock. A. Spindler and AD report no conflicts of interest. Address correspondence to Dr. M.C. Genovese, James W. Raitt Professor of Medicine, Co-Chief, Division of Immunology and Rheumatology, Stanford University School of Medicine, 1000 Welch Road, Suite 203, Palo Alto, CA 94304, USA. Email: genovese@stanford.edu. Accepted for publication October 28, 2020.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Dudek', 'Affiliation': 'This trial was funded by Eli Lilly and Company, under license from Hanmi. M.C. Genovese, MD, Division of Immunology and Rheumatology, Stanford University, Palo Alto, California, USA; A. Spindler, MD, Centro Medico Privado de Reumatologia, Tucumán, Argentina; A. Sagawa, MD, Sagawa Akira Rheumatology Clinic, Sapporo, Japan; W. Park, MD, PhD, Division of Rheumatology, IN-HA University, Incheon, Korea; A. Dudek, MD, PhD, AMED Medical Center, Warsaw, Poland; A. Kivitz MD, CPI, Altoona Center for Clinical Research, Duncansville, Pennsylvania, USA; J. Chao, MD, L. Chan, MS, J. Witcher, PhD, W. Barchuk, MD, A. Nirula, MD, PhD, Eli Lilly and Company, Indianapolis, Indiana, USA. MCG is currently an employee of Gilead Sciences Inc. and holds stock options; he reports personal fees and other fees from Eli Lilly and Company, during the conduct of the study; personal fees and other fees from AbbVie, Gilead, and other from Galapagos and Pfizer, outside the submitted work. A. Sagawa reports being a paid instructor for ONO Pharmaceutical, Eli Lilly Japan, K.K., Takeda, AYUMI Pharmaceutical, Kissei Pharmaceutical, Chugai Pharmaceutical, Asahi Kasei Pharma Corporation, and Janssen. WP reports consulting fees from Celltrion. AK reports being a shareholder of Pfizer, Sanofi, GlaxoSmithKline, Gilead Sciences Inc., Novartis; a paid consultant for AbbVie, Boehringer Ingelheim, Flexion, Janssen, Pfizer, Sanofi, Regeneron, SUN Pharma Advanced Research, Gilead Sciences Inc.; and on the speakers bureau of Celgene, Merck, Lilly, Novartis, Pfizer, Sanofi, Genzyme, Flexion, AbbVie. JC, LC, JW, and AN are employees and stockholders of Eli Lilly. WB was an employee of Eli Lilly at the time of this study and currently is an employee of Gilead Sciences, Inc. and owns Gilead stock. A. Spindler and AD report no conflicts of interest. Address correspondence to Dr. M.C. Genovese, James W. Raitt Professor of Medicine, Co-Chief, Division of Immunology and Rheumatology, Stanford University School of Medicine, 1000 Welch Road, Suite 203, Palo Alto, CA 94304, USA. Email: genovese@stanford.edu. Accepted for publication October 28, 2020.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Kivitz', 'Affiliation': 'This trial was funded by Eli Lilly and Company, under license from Hanmi. M.C. Genovese, MD, Division of Immunology and Rheumatology, Stanford University, Palo Alto, California, USA; A. Spindler, MD, Centro Medico Privado de Reumatologia, Tucumán, Argentina; A. Sagawa, MD, Sagawa Akira Rheumatology Clinic, Sapporo, Japan; W. Park, MD, PhD, Division of Rheumatology, IN-HA University, Incheon, Korea; A. Dudek, MD, PhD, AMED Medical Center, Warsaw, Poland; A. Kivitz MD, CPI, Altoona Center for Clinical Research, Duncansville, Pennsylvania, USA; J. Chao, MD, L. Chan, MS, J. Witcher, PhD, W. Barchuk, MD, A. Nirula, MD, PhD, Eli Lilly and Company, Indianapolis, Indiana, USA. MCG is currently an employee of Gilead Sciences Inc. and holds stock options; he reports personal fees and other fees from Eli Lilly and Company, during the conduct of the study; personal fees and other fees from AbbVie, Gilead, and other from Galapagos and Pfizer, outside the submitted work. A. Sagawa reports being a paid instructor for ONO Pharmaceutical, Eli Lilly Japan, K.K., Takeda, AYUMI Pharmaceutical, Kissei Pharmaceutical, Chugai Pharmaceutical, Asahi Kasei Pharma Corporation, and Janssen. WP reports consulting fees from Celltrion. AK reports being a shareholder of Pfizer, Sanofi, GlaxoSmithKline, Gilead Sciences Inc., Novartis; a paid consultant for AbbVie, Boehringer Ingelheim, Flexion, Janssen, Pfizer, Sanofi, Regeneron, SUN Pharma Advanced Research, Gilead Sciences Inc.; and on the speakers bureau of Celgene, Merck, Lilly, Novartis, Pfizer, Sanofi, Genzyme, Flexion, AbbVie. JC, LC, JW, and AN are employees and stockholders of Eli Lilly. WB was an employee of Eli Lilly at the time of this study and currently is an employee of Gilead Sciences, Inc. and owns Gilead stock. A. Spindler and AD report no conflicts of interest. Address correspondence to Dr. M.C. Genovese, James W. Raitt Professor of Medicine, Co-Chief, Division of Immunology and Rheumatology, Stanford University School of Medicine, 1000 Welch Road, Suite 203, Palo Alto, CA 94304, USA. Email: genovese@stanford.edu. Accepted for publication October 28, 2020.'}, {'ForeName': 'Jeannie', 'Initials': 'J', 'LastName': 'Chao', 'Affiliation': 'This trial was funded by Eli Lilly and Company, under license from Hanmi. M.C. Genovese, MD, Division of Immunology and Rheumatology, Stanford University, Palo Alto, California, USA; A. Spindler, MD, Centro Medico Privado de Reumatologia, Tucumán, Argentina; A. Sagawa, MD, Sagawa Akira Rheumatology Clinic, Sapporo, Japan; W. Park, MD, PhD, Division of Rheumatology, IN-HA University, Incheon, Korea; A. Dudek, MD, PhD, AMED Medical Center, Warsaw, Poland; A. Kivitz MD, CPI, Altoona Center for Clinical Research, Duncansville, Pennsylvania, USA; J. Chao, MD, L. Chan, MS, J. Witcher, PhD, W. Barchuk, MD, A. Nirula, MD, PhD, Eli Lilly and Company, Indianapolis, Indiana, USA. MCG is currently an employee of Gilead Sciences Inc. and holds stock options; he reports personal fees and other fees from Eli Lilly and Company, during the conduct of the study; personal fees and other fees from AbbVie, Gilead, and other from Galapagos and Pfizer, outside the submitted work. A. Sagawa reports being a paid instructor for ONO Pharmaceutical, Eli Lilly Japan, K.K., Takeda, AYUMI Pharmaceutical, Kissei Pharmaceutical, Chugai Pharmaceutical, Asahi Kasei Pharma Corporation, and Janssen. WP reports consulting fees from Celltrion. AK reports being a shareholder of Pfizer, Sanofi, GlaxoSmithKline, Gilead Sciences Inc., Novartis; a paid consultant for AbbVie, Boehringer Ingelheim, Flexion, Janssen, Pfizer, Sanofi, Regeneron, SUN Pharma Advanced Research, Gilead Sciences Inc.; and on the speakers bureau of Celgene, Merck, Lilly, Novartis, Pfizer, Sanofi, Genzyme, Flexion, AbbVie. JC, LC, JW, and AN are employees and stockholders of Eli Lilly. WB was an employee of Eli Lilly at the time of this study and currently is an employee of Gilead Sciences, Inc. and owns Gilead stock. A. Spindler and AD report no conflicts of interest. Address correspondence to Dr. M.C. Genovese, James W. Raitt Professor of Medicine, Co-Chief, Division of Immunology and Rheumatology, Stanford University School of Medicine, 1000 Welch Road, Suite 203, Palo Alto, CA 94304, USA. Email: genovese@stanford.edu. Accepted for publication October 28, 2020.'}, {'ForeName': 'Melanie Lai Shan', 'Initials': 'MLS', 'LastName': 'Chan', 'Affiliation': 'This trial was funded by Eli Lilly and Company, under license from Hanmi. M.C. Genovese, MD, Division of Immunology and Rheumatology, Stanford University, Palo Alto, California, USA; A. Spindler, MD, Centro Medico Privado de Reumatologia, Tucumán, Argentina; A. Sagawa, MD, Sagawa Akira Rheumatology Clinic, Sapporo, Japan; W. Park, MD, PhD, Division of Rheumatology, IN-HA University, Incheon, Korea; A. Dudek, MD, PhD, AMED Medical Center, Warsaw, Poland; A. Kivitz MD, CPI, Altoona Center for Clinical Research, Duncansville, Pennsylvania, USA; J. Chao, MD, L. Chan, MS, J. Witcher, PhD, W. Barchuk, MD, A. Nirula, MD, PhD, Eli Lilly and Company, Indianapolis, Indiana, USA. MCG is currently an employee of Gilead Sciences Inc. and holds stock options; he reports personal fees and other fees from Eli Lilly and Company, during the conduct of the study; personal fees and other fees from AbbVie, Gilead, and other from Galapagos and Pfizer, outside the submitted work. A. Sagawa reports being a paid instructor for ONO Pharmaceutical, Eli Lilly Japan, K.K., Takeda, AYUMI Pharmaceutical, Kissei Pharmaceutical, Chugai Pharmaceutical, Asahi Kasei Pharma Corporation, and Janssen. WP reports consulting fees from Celltrion. AK reports being a shareholder of Pfizer, Sanofi, GlaxoSmithKline, Gilead Sciences Inc., Novartis; a paid consultant for AbbVie, Boehringer Ingelheim, Flexion, Janssen, Pfizer, Sanofi, Regeneron, SUN Pharma Advanced Research, Gilead Sciences Inc.; and on the speakers bureau of Celgene, Merck, Lilly, Novartis, Pfizer, Sanofi, Genzyme, Flexion, AbbVie. JC, LC, JW, and AN are employees and stockholders of Eli Lilly. WB was an employee of Eli Lilly at the time of this study and currently is an employee of Gilead Sciences, Inc. and owns Gilead stock. A. Spindler and AD report no conflicts of interest. Address correspondence to Dr. M.C. Genovese, James W. Raitt Professor of Medicine, Co-Chief, Division of Immunology and Rheumatology, Stanford University School of Medicine, 1000 Welch Road, Suite 203, Palo Alto, CA 94304, USA. Email: genovese@stanford.edu. Accepted for publication October 28, 2020.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Witcher', 'Affiliation': 'This trial was funded by Eli Lilly and Company, under license from Hanmi. M.C. Genovese, MD, Division of Immunology and Rheumatology, Stanford University, Palo Alto, California, USA; A. Spindler, MD, Centro Medico Privado de Reumatologia, Tucumán, Argentina; A. Sagawa, MD, Sagawa Akira Rheumatology Clinic, Sapporo, Japan; W. Park, MD, PhD, Division of Rheumatology, IN-HA University, Incheon, Korea; A. Dudek, MD, PhD, AMED Medical Center, Warsaw, Poland; A. Kivitz MD, CPI, Altoona Center for Clinical Research, Duncansville, Pennsylvania, USA; J. Chao, MD, L. Chan, MS, J. Witcher, PhD, W. Barchuk, MD, A. Nirula, MD, PhD, Eli Lilly and Company, Indianapolis, Indiana, USA. MCG is currently an employee of Gilead Sciences Inc. and holds stock options; he reports personal fees and other fees from Eli Lilly and Company, during the conduct of the study; personal fees and other fees from AbbVie, Gilead, and other from Galapagos and Pfizer, outside the submitted work. A. Sagawa reports being a paid instructor for ONO Pharmaceutical, Eli Lilly Japan, K.K., Takeda, AYUMI Pharmaceutical, Kissei Pharmaceutical, Chugai Pharmaceutical, Asahi Kasei Pharma Corporation, and Janssen. WP reports consulting fees from Celltrion. AK reports being a shareholder of Pfizer, Sanofi, GlaxoSmithKline, Gilead Sciences Inc., Novartis; a paid consultant for AbbVie, Boehringer Ingelheim, Flexion, Janssen, Pfizer, Sanofi, Regeneron, SUN Pharma Advanced Research, Gilead Sciences Inc.; and on the speakers bureau of Celgene, Merck, Lilly, Novartis, Pfizer, Sanofi, Genzyme, Flexion, AbbVie. JC, LC, JW, and AN are employees and stockholders of Eli Lilly. WB was an employee of Eli Lilly at the time of this study and currently is an employee of Gilead Sciences, Inc. and owns Gilead stock. A. Spindler and AD report no conflicts of interest. Address correspondence to Dr. M.C. Genovese, James W. Raitt Professor of Medicine, Co-Chief, Division of Immunology and Rheumatology, Stanford University School of Medicine, 1000 Welch Road, Suite 203, Palo Alto, CA 94304, USA. Email: genovese@stanford.edu. Accepted for publication October 28, 2020.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Barchuk', 'Affiliation': 'This trial was funded by Eli Lilly and Company, under license from Hanmi. M.C. Genovese, MD, Division of Immunology and Rheumatology, Stanford University, Palo Alto, California, USA; A. Spindler, MD, Centro Medico Privado de Reumatologia, Tucumán, Argentina; A. Sagawa, MD, Sagawa Akira Rheumatology Clinic, Sapporo, Japan; W. Park, MD, PhD, Division of Rheumatology, IN-HA University, Incheon, Korea; A. Dudek, MD, PhD, AMED Medical Center, Warsaw, Poland; A. Kivitz MD, CPI, Altoona Center for Clinical Research, Duncansville, Pennsylvania, USA; J. Chao, MD, L. Chan, MS, J. Witcher, PhD, W. Barchuk, MD, A. Nirula, MD, PhD, Eli Lilly and Company, Indianapolis, Indiana, USA. MCG is currently an employee of Gilead Sciences Inc. and holds stock options; he reports personal fees and other fees from Eli Lilly and Company, during the conduct of the study; personal fees and other fees from AbbVie, Gilead, and other from Galapagos and Pfizer, outside the submitted work. A. Sagawa reports being a paid instructor for ONO Pharmaceutical, Eli Lilly Japan, K.K., Takeda, AYUMI Pharmaceutical, Kissei Pharmaceutical, Chugai Pharmaceutical, Asahi Kasei Pharma Corporation, and Janssen. WP reports consulting fees from Celltrion. AK reports being a shareholder of Pfizer, Sanofi, GlaxoSmithKline, Gilead Sciences Inc., Novartis; a paid consultant for AbbVie, Boehringer Ingelheim, Flexion, Janssen, Pfizer, Sanofi, Regeneron, SUN Pharma Advanced Research, Gilead Sciences Inc.; and on the speakers bureau of Celgene, Merck, Lilly, Novartis, Pfizer, Sanofi, Genzyme, Flexion, AbbVie. JC, LC, JW, and AN are employees and stockholders of Eli Lilly. WB was an employee of Eli Lilly at the time of this study and currently is an employee of Gilead Sciences, Inc. and owns Gilead stock. A. Spindler and AD report no conflicts of interest. Address correspondence to Dr. M.C. Genovese, James W. Raitt Professor of Medicine, Co-Chief, Division of Immunology and Rheumatology, Stanford University School of Medicine, 1000 Welch Road, Suite 203, Palo Alto, CA 94304, USA. Email: genovese@stanford.edu. Accepted for publication October 28, 2020.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Nirula', 'Affiliation': 'This trial was funded by Eli Lilly and Company, under license from Hanmi. M.C. Genovese, MD, Division of Immunology and Rheumatology, Stanford University, Palo Alto, California, USA; A. Spindler, MD, Centro Medico Privado de Reumatologia, Tucumán, Argentina; A. Sagawa, MD, Sagawa Akira Rheumatology Clinic, Sapporo, Japan; W. Park, MD, PhD, Division of Rheumatology, IN-HA University, Incheon, Korea; A. Dudek, MD, PhD, AMED Medical Center, Warsaw, Poland; A. Kivitz MD, CPI, Altoona Center for Clinical Research, Duncansville, Pennsylvania, USA; J. Chao, MD, L. Chan, MS, J. Witcher, PhD, W. Barchuk, MD, A. Nirula, MD, PhD, Eli Lilly and Company, Indianapolis, Indiana, USA. MCG is currently an employee of Gilead Sciences Inc. and holds stock options; he reports personal fees and other fees from Eli Lilly and Company, during the conduct of the study; personal fees and other fees from AbbVie, Gilead, and other from Galapagos and Pfizer, outside the submitted work. A. Sagawa reports being a paid instructor for ONO Pharmaceutical, Eli Lilly Japan, K.K., Takeda, AYUMI Pharmaceutical, Kissei Pharmaceutical, Chugai Pharmaceutical, Asahi Kasei Pharma Corporation, and Janssen. WP reports consulting fees from Celltrion. AK reports being a shareholder of Pfizer, Sanofi, GlaxoSmithKline, Gilead Sciences Inc., Novartis; a paid consultant for AbbVie, Boehringer Ingelheim, Flexion, Janssen, Pfizer, Sanofi, Regeneron, SUN Pharma Advanced Research, Gilead Sciences Inc.; and on the speakers bureau of Celgene, Merck, Lilly, Novartis, Pfizer, Sanofi, Genzyme, Flexion, AbbVie. JC, LC, JW, and AN are employees and stockholders of Eli Lilly. WB was an employee of Eli Lilly at the time of this study and currently is an employee of Gilead Sciences, Inc. and owns Gilead stock. A. Spindler and AD report no conflicts of interest. Address correspondence to Dr. M.C. Genovese, James W. Raitt Professor of Medicine, Co-Chief, Division of Immunology and Rheumatology, Stanford University School of Medicine, 1000 Welch Road, Suite 203, Palo Alto, CA 94304, USA. Email: genovese@stanford.edu. Accepted for publication October 28, 2020.'}]",The Journal of rheumatology,['10.3899/jrheum.200893'] 1718,33330958,Intravitreal Aflibercept in Japanese Patients with Neovascular Glaucoma: The VEGA Randomized Clinical Trial.,"INTRODUCTION Neovascular glaucoma is characterized by neovascularization of the iris and the anterior angle chamber. Intravitreal anti-vascular endothelial growth factor agents may improve intraocular pressure (IOP) and neovascularization. METHODS The VEGA trial assessed the efficacy and safety of intravitreal aflibercept (IVT-AFL) in patients with neovascular glaucoma in a 13-week, randomized, double-masked, sham-controlled, phase 3 study performed at multiple sites in Japan that enrolled patients with anterior segment neovascularization and IOP > 25 mmHg. Patients received background therapy plus IVT-AFL (2 mg) or sham injection at baseline. Patients were re-treated if presenting with IOP > 21 mmHg and incomplete regression of iris neovascularization, receiving additional sham or IVT-AFL injections at week 1 and IVT-AFL injections at weeks 5 and/or 9. Double-masking was maintained throughout. The primary endpoint was change in IOP from baseline to week 1. RESULTS Fifty-four patients were randomly assigned (full analysis set); the per-protocol set comprised 52 patients. At week 1, the least squares mean change in IOP was -9.9 mmHg for IVT-AFL versus -5.0 mmHg for sham [full analysis set: difference -4.9 mmHg (95% confidence interval -10.2 to 0.3; P = 0.06); per-protocol set: -5.5 mmHg (95% CI -10.8 to -0.2; P = 0.04)]. At week 1, a greater proportion of patients administered IVT-AFL versus sham achieved IOP ≤ 21 mmHg and had improved neovascularization grades. Patients in the sham group who met re-treatment criteria and received IVT-AFL at week 1 [n = 22 (81.5%)] had an additional mean IOP decrease of 9.2 mmHg by week 2, and the proportion with improvement in neovascularization grades increased from 11.5% to 69.2%. Increases in the proportion of patients with improved neovascularization grades and the proportion who achieved IOP control (≤ 21 mmHg) were also observed by week 2 in this group. Overall, 77.8% and 74.1% of patients treated with IVT-AFL and sham/IVT-AFL, respectively, received a single IVT-AFL injection. The most common ocular treatment-emergent adverse event was punctate keratitis (9.3%: 7.4% and 11.1% in the IVT-AFL and sham/IVT-AFL groups, respectively). CONCLUSIONS IVT-AFL was associated with clinically meaningful improvements in IOP control, indicating that IVT-AFL may be a potential treatment option for patients with neovascular glaucoma. TRIAL REGISTRATION Clinicaltrials.gov identifier, NCT02396316.",2021,"The most common ocular treatment-emergent adverse event was punctate keratitis (9.3%: 7.4% and 11.1% in the IVT-AFL and sham/IVT-AFL groups, respectively). ","['enrolled patients with anterior segment neovascularization and IOP\u2009', 'Fifty-four patients', 'patients with neovascular glaucoma', 'Japanese Patients with Neovascular Glaucoma', 'Patients were re-treated if presenting with IOP\u2009']","['IVT-AFL', 'Intravitreal Aflibercept', 'intravitreal aflibercept (IVT-AFL', 'IVT-AFL injections', 'Intravitreal anti-vascular endothelial growth factor agents', 'background therapy plus IVT-AFL']","['punctate keratitis', 'IOP', 'efficacy and safety', 'intraocular pressure (IOP) and neovascularization', 'neovascularization grades', 'change in IOP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003153', 'cui_str': 'Anterior eyeball segment structure'}, {'cui': 'C0027686', 'cui_str': 'Neovascularization'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0017609', 'cui_str': 'Neovascular glaucoma'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0259799', 'cui_str': 'Superficial punctate keratitis'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027686', 'cui_str': 'Neovascularization'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",54.0,0.365754,"The most common ocular treatment-emergent adverse event was punctate keratitis (9.3%: 7.4% and 11.1% in the IVT-AFL and sham/IVT-AFL groups, respectively). ","[{'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Inatani', 'Affiliation': 'Department of Ophthalmology, Faculty of Medical Sciences, University of Fukui, Fukui, Japan. inatani@u-fukui.ac.jp.'}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Higashide', 'Affiliation': 'Department of Ophthalmology, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Matsushita', 'Affiliation': 'Department of Ophthalmology, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Atsuya', 'Initials': 'A', 'LastName': 'Miki', 'Affiliation': 'Department of Ophthalmology, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Ueki', 'Affiliation': 'Department of Ophthalmology, Osaka Medical College, Takatsuki-City, Osaka, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Iwamoto', 'Affiliation': 'Bayer Yakuhin, Ltd., Osaka, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Kobayashi', 'Affiliation': 'Bayer Yakuhin, Ltd., Osaka, Japan.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Leal', 'Affiliation': 'Bayer Consumer Care AG, Basel, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Advances in therapy,['10.1007/s12325-020-01579-5'] 1719,33319866,"Preventive effect of ramelteon on emergence agitation after general anaesthesia in paediatric patients undergoing tonsillectomy: a randomised, placebo-controlled clinical trial.","Purpose of this prospective, double-blind, parallel-group, placebo-controlled, randomised clinical trial was to confirm our hypothesis that ramelteon has a preventive effect on emergence agitation after general anaesthesia in children. Patients aged 18 to 119 months (ASA physical status 1 or 2), scheduled to undergo tonsillectomy under general anaesthesia, were randomly allocated to the ramelteon or placebo group. Before general anaesthesia induction, patients in the ramelteon group received 0.1 mg kg -1 of ramelteon dissolved in 5 mL of lactose-containing syrup. The patients in the placebo group received the same amount of syrup alone. The Paediatric Anaesthesia Emergence Delirium score was calculated every 5 min after awakening. The primary outcome was the incidence of emergence agitation (Paediatric Anaesthesia Emergence Delirium score ≥ 10). Paediatric Anaesthesia Emergence Delirium scores, post-operative vomiting incidence, pain scores, and adverse events were secondary outcomes. Fifty patients were enrolled. Forty-eight patients were analysed. There was no significant between-group difference in the incidence of emergence agitation (67% in both groups; risk ratio, 1.0; 95% CI 0.67-1.49; P > 0.99) or any of the secondary outcomes. Our results suggest that 0.1 mg kg -1 of ramelteon does not have a preventive effect on emergence agitation after general anaesthesia in children undergoing tonsillectomy.",2020,"There was no significant between-group difference in the incidence of emergence agitation (67% in both groups; risk ratio, 1.0; 95% CI 0.67-1.49; P > 0.99) or any of the secondary outcomes.","['children', 'Patients aged 18 to 119\xa0months (ASA physical status 1 or 2), scheduled to undergo tonsillectomy under general anaesthesia', 'Forty-eight patients were analysed', 'children undergoing tonsillectomy', 'paediatric patients undergoing tonsillectomy', 'Fifty patients were enrolled']","['ramelteon', '0.1\xa0mg\xa0kg -1 of ramelteon dissolved in 5\xa0mL of lactose-containing syrup', 'placebo', 'syrup alone']","['incidence of emergence agitation', 'Paediatric Anaesthesia Emergence Delirium score', 'incidence of emergence agitation (Paediatric Anaesthesia Emergence Delirium score\u2009≥\u200910', 'Paediatric Anaesthesia Emergence Delirium scores, post-operative vomiting incidence, pain scores, and adverse events']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C1565316', 'cui_str': 'ramelteon'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C1549535', 'cui_str': 'Dissolve'}, {'cui': 'C0022949', 'cui_str': 'Lactose'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0458173', 'cui_str': 'Syrup'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0920253', 'cui_str': 'Agitated Emergence'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",48.0,0.600987,"There was no significant between-group difference in the incidence of emergence agitation (67% in both groups; risk ratio, 1.0; 95% CI 0.67-1.49; P > 0.99) or any of the secondary outcomes.","[{'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Komazaki', 'Affiliation': ""Department of Anesthesiology, Kanagawa Children's Medical Center, Yokohama, 232-8555, Japan.""}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Mihara', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Yokohama City University Graduate School of Medicine, Yokohama, 236-0004, Japan. meta.analysis.r@gmail.com.'}, {'ForeName': 'Nobuhito', 'Initials': 'N', 'LastName': 'Nakamura', 'Affiliation': ""Department of Anesthesiology, Kanagawa Children's Medical Center, Yokohama, 232-8555, Japan.""}, {'ForeName': 'Koui', 'Initials': 'K', 'LastName': 'Ka', 'Affiliation': ""Department of Anesthesiology, Kanagawa Children's Medical Center, Yokohama, 232-8555, Japan.""}, {'ForeName': 'Takahisa', 'Initials': 'T', 'LastName': 'Goto', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Yokohama City University Graduate School of Medicine, Yokohama, 236-0004, Japan.'}]",Scientific reports,['10.1038/s41598-020-79078-4'] 1720,33338583,"Safety of Ashwagandha Root Extract: A Randomized, Placebo-Controlled, study in Healthy Volunteers.","BACKGROUND Ashwagandha (Withania somnifera) is a well-established and reputed herb in Ayurvedic medicine. It has been used as a ""Rasayana"" (rejuvenator), nootropic, and as a powerful natural adaptogen. The herb extract is extensively used for general wellbeing and in specific ailments. However, only a few studies have investigated the safety and tolerability of Ashwagandha in humans. This study evaluated the safety of Ashwagandha root extract consumption in healthy adults. METHODS In this randomized, double-blind, placebo-controlled, and parallel-group study, 80 healthy participants (40 males, 40 females) were randomized in a 1:1 ratio to receive either Ashwagandha 300 mg or a placebo of the same dosage, twice daily, orally for 8 weeks. The study was conducted at MV Hospital, and King George Medical University, Lucknow, India. The primary safety outcomes considered were laboratory assessment of hematological parameters, serum biochemistry analysis including hepatotoxicity evaluation, and thyroid function parameters. The secondary outcomes of this study were the clinical adverse events and the vital parameters. The within and between the groups' datasets were compared using the Wilcoxon signed-rank test and the Mann Whitney U test, respectively. RESULTS A detailed evaluation of the vital signs such as body weight, body temperature, pulse rate, respiratory rate, systolic and diastolic blood pressure, and Body Mass Index (BMI) were conducted for each participant at the baseline and the end of the study for treatment and placebo groups. Similarly, hematological and biochemical parameters were evaluated at the baseline and at the end of study. The outcome did not indicate any untoward effects in any of the treated volunteers. No statistically significant change or abnormality was observed in the considered parameters including thyroid hormonal profile in both the groups. No adverse events were reported by any of the participants in this study. CONCLUSIONS Ashwagandha is being consumed since time immemorial following the Ayurvedic medicine practices. Modern science requires evidence of the safety and efficacy of the Ashwagandha extract before mass consumption for various health issues and as a supplement. The present study revealed that the consumption of Ashwagandha root extract for 8 weeks was safe in both males and females volunteers. However, long term study and varying dosage ranges should be investigated in the future.",2021,No statistically significant change or abnormality was observed in the considered parameters including thyroid hormonal profile in both the groups.,"['males and females volunteers', '80 healthy participants (40 males, 40 females', 'Healthy Volunteers', 'healthy adults']","['placebo', 'Ashwagandha Root Extract', 'Ashwagandha root extract consumption', 'Placebo', 'Ashwagandha 300\u2009mg or a starch placebo']","['clinical adverse events and the vital parameters', 'safety and tolerability', 'hematological and biochemical parameters', 'thyroid hormonal profile', 'adverse events', 'body weight, body temperature, pulse rate, respiratory rate, systolic and diastolic blood pressure, and Body Mass Index (BMI', 'laboratory assessment of hematological parameters, serum biochemistry analysis including hepatotoxicity evaluation, and thyroid function parameters']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0613707', 'cui_str': 'Ashwagandha'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0038179', 'cui_str': 'Starch'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",80.0,0.0702887,No statistically significant change or abnormality was observed in the considered parameters including thyroid hormonal profile in both the groups.,"[{'ForeName': 'Narsing', 'Initials': 'N', 'LastName': 'Verma', 'Affiliation': ""King George's Medical University, Chowk, Lucknow, 226003, Uttar Pradesh, India.""}, {'ForeName': 'Sandeep Kumar', 'Initials': 'SK', 'LastName': 'Gupta', 'Affiliation': 'M V Hospital and Research Centre, 314/30 Mirza Mandi, Post Office, Chowk, Lucknow, 226003, Uttar Pradesh, India.'}, {'ForeName': 'Shashank', 'Initials': 'S', 'LastName': 'Tiwari', 'Affiliation': 'M V Hospital and Research Centre, 314/30 Mirza Mandi, Post Office, Chowk, Lucknow, 226003, Uttar Pradesh, India.'}, {'ForeName': 'Ashok Kumar', 'Initials': 'AK', 'LastName': 'Mishra', 'Affiliation': 'M V Hospital and Research Centre, 314/30 Mirza Mandi, Post Office, Chowk, Lucknow, 226003, Uttar Pradesh, India. Electronic address: akmishramvhr@gmail.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102642'] 1721,33319846,Transcutaneous spinal direct current stimulation shows no effect on paired stimulation suppression of the somatosensory cortex.,"Transcutaneous spinal direct current stimulation (tsDCS) is a safe and convenient method of neuromodulation. It has been proven to alter sensory processing at cervicomedullary level by amplitude changes of the P30 response of tibial nerve somatosensory evoked potentials (TN SEPs). With knowledge that tsDCS affects cortical circuits, we hypothesized that tsDCS may also affect intracortical excitability of the somatosensory cortex assessed by paired stimulation suppression (PSS). Fourteen healthy men were included in this prospective, single-blinded, placebo-controlled crossover study. Single (SS) and paired stimulation (PS) TN SEPs were recorded over the scalp before, immediately as well as 30 and 60 min after applying 15 min of tsDCS over the twelfth thoracic vertebra. Each volunteer underwent three independent and randomized sessions of either cathodal, anodal or sham stimulation. tsDCS showed no effect on peak-to-peak amplitudes or latencies of cortical P40-N50 response after SS. Furthermore, tsDCS failed to induce significant changes on amplitude ratios of PSS, thus showing no impact on intracortical excitability of the somatosensory cortex in healthy subjects. Further research is required to reveal the different mechanisms and to strengthen clinical use of this promising technique.",2020,tsDCS showed no effect on peak-to-peak amplitudes or latencies of cortical P40-N50 response after SS.,"['Fourteen healthy men', 'healthy subjects']","['Transcutaneous spinal direct current stimulation (tsDCS', 'Transcutaneous spinal direct current stimulation', 'cathodal, anodal or sham stimulation', 'placebo', 'tsDCS', 'Single (SS) and paired stimulation']","['intracortical excitability', 'peak-to-peak amplitudes or latencies of cortical P40-N50 response', 'amplitude ratios of PSS']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0079407', 'cui_str': 'Gene Product, tax'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",14.0,0.0712059,tsDCS showed no effect on peak-to-peak amplitudes or latencies of cortical P40-N50 response after SS.,"[{'ForeName': 'Jan H', 'Initials': 'JH', 'LastName': 'Bettmann', 'Affiliation': 'Department of Neurology, BG-Universitätsklinikum Bergmannsheil gGmbH, Bürkle-de-la-Camp-Platz 1, 44789, Bochum, Germany.'}, {'ForeName': 'Christine H', 'Initials': 'CH', 'LastName': 'Meyer-Frießem', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Management, BG-Universitätsklinikum Bergmannsheil gGmbH, Bürkle-de-la-Camp-Platz 1, 44789, Bochum, Germany. christine.meyer-friessem@rub.de.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Schweizer', 'Affiliation': 'Department of Neurology, BG-Universitätsklinikum Bergmannsheil gGmbH, Bürkle-de-la-Camp-Platz 1, 44789, Bochum, Germany.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Schlaffke', 'Affiliation': 'Department of Neurology, BG-Universitätsklinikum Bergmannsheil gGmbH, Bürkle-de-la-Camp-Platz 1, 44789, Bochum, Germany.'}, {'ForeName': 'Peter K', 'Initials': 'PK', 'LastName': 'Zahn', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Management, BG-Universitätsklinikum Bergmannsheil gGmbH, Bürkle-de-la-Camp-Platz 1, 44789, Bochum, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Tegenthoff', 'Affiliation': 'Department of Neurology, BG-Universitätsklinikum Bergmannsheil gGmbH, Bürkle-de-la-Camp-Platz 1, 44789, Bochum, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Höffken', 'Affiliation': 'Department of Neurology, BG-Universitätsklinikum Bergmannsheil gGmbH, Bürkle-de-la-Camp-Platz 1, 44789, Bochum, Germany.'}]",Scientific reports,['10.1038/s41598-020-79131-2'] 1722,33319792,"Impact of outdoor nature-related activities on gut microbiota, fecal serotonin, and perceived stress in preschool children: the Play&Grow randomized controlled trial.","Due to rapid urbanization, children today have fewer opportunities to interact with nature and this may result in a greater risk for developing stress and depression. Outdoor nature-related activities can enhance general well-being. However, the underlying mechanisms are not fully delineated. Here we recruited 54 preschool children to participate in a 10-week structured nature-related ""Play&Grow"" program. Following the intervention, children were assessed for connectedness to nature and perceived stress levels using validated questionnaires. Moreover, fecal serotonin level and gut microbiota profiles were measured by ELISA and 16S rDNA amplicon sequencing, respectively. Children were significantly more connected to nature after the intervention. Their gut microbiota altered, especially by modulating the abundance of Roseburia and the fecal-serotonin level. Moreover, we also observed a reduction in the overall perceived stress, particularly in the frequency of anger among these children. This study is the first to demonstrate the impact of nature-related activities on gut microbiota, fecal serotonin and psychosocial behaviour of preschool children. However, further mechanistic studies are needed to confirm the functional role of gut microbiota in the association between connectedness to nature and improved psychosocial behavior.",2020,Children were significantly more connected to nature after the intervention.,"['54 preschool children to participate in a 10-week structured nature-related ""Play&Grow"" program', 'preschool children']",['outdoor nature-related activities'],"['gut microbiota, fecal serotonin, and perceived stress', 'fecal serotonin level and gut microbiota profiles']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0202217', 'cui_str': 'Serotonin measurement'}]",54.0,0.0180387,Children were significantly more connected to nature after the intervention.,"[{'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Sobko', 'Affiliation': 'School of Biological Sciences, Faculty of Science, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Suisha', 'Initials': 'S', 'LastName': 'Liang', 'Affiliation': 'HKU-Pasteur Research Pole, School of Public Health, Li Ka Shing Faculty of Medicine, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Will H G', 'Initials': 'WHG', 'LastName': 'Cheng', 'Affiliation': 'School of Biological Sciences, Faculty of Science, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Hein M', 'Initials': 'HM', 'LastName': 'Tun', 'Affiliation': 'HKU-Pasteur Research Pole, School of Public Health, Li Ka Shing Faculty of Medicine, University of Hong Kong, Hong Kong SAR, China. heinmtun@hku.hk.'}]",Scientific reports,['10.1038/s41598-020-78642-2'] 1723,33370050,Prospective Randomized Trial Comparing Opioids versus Nonsteroidal Antiinflammatory Drugs for Postoperative Analgesia in Outpatient Rhinoplasty.,"BACKGROUND The misuse and abuse of opioids, including overprescription, has led to the current opioid epidemic and national crisis. There is a national effort to eliminate the unnecessary prescription of opioids for analgesia. METHODS Seventy patients were randomized to receive postoperative analgesia with either 5 mg hydrocodone with 325 mg acetaminophen (opioid control group) or 400 mg of ibuprofen [nonsteroidal antiinflammatory drug (NSAID) experimental group]. Pain levels were assessed on postoperative days 1, 2, and 7. Outcome measures included numeric pain rating scores and assessments of frequency and amount of analgesic used. RESULTS There was no significant difference in gender (p = 0.81) or age (p = 0.61) between groups. On postoperative day 0, the NSAID group (mean ± SD, 2.54 ± 1.57) was found to be noninferior to the opioid group (mean ± SD, 3.14 ± 1.75; p = 0.003). On postoperative day 1, the NSAID group showed a lower mean pain score (mean ± SD, 1.84 ± 1.29) than the opioid group (mean ± SD, 2.46 ± 1.90; p = 0.01). However, on postoperative day 7, the difference in pain scores between the NSAID (mean ± SD, 3.29 ± 2.14) and opioid (mean ± SD, 3.14 ± 2.12; p = 0.17) groups lost statistical significance. There was no significant difference in mean day of medication cessation between the NSAID (mean ± SD, 4.73 ± 1.57) and opioid (mean ± SD, 4.28 ± 2.23; p = 0.26) groups. Seventy-six percent of patients who were prescribed opioids took fewer than eight tablets. Five patients escalated from NSAIDs to opioids. There were no adverse effects related to NSAID use. CONCLUSIONS NSAIDs are an acceptable and safe alternative to opioids for postoperative analgesia in rhinoplasty and potentially lead to better overall pain control in some patients. Significantly reducing or eliminating opioid prescriptions may be considered in light of the current opioid epidemic. CLINICAL QUESTION/LEVEL OF EVIDENCE Therapeutic, II.",2021,"On postoperative day 1, the NSAID group showed a lower mean pain score (mean ± SD, 1.84 ± 1.29) than the opioid group (mean ± SD, 2.46 ± 1.90; p = 0.01).","['Seventy-six percent of patients who were prescribed opioids took fewer than eight tablets', 'Postoperative Analgesia in Outpatient Rhinoplasty', 'Seventy patients']","['postoperative analgesia with either 5 mg hydrocodone', 'acetaminophen (opioid control group) or 400 mg of ibuprofen [nonsteroidal antiinflammatory drug (NSAID']","['Pain levels', 'mean pain score', 'pain scores', 'mean day of medication cessation', 'numeric pain rating scores and assessments of frequency and amount of analgesic used']","[{'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0035467', 'cui_str': 'Rhinoplasty'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0020264', 'cui_str': 'Hydrocodone'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]",70.0,0.036338,"On postoperative day 1, the NSAID group showed a lower mean pain score (mean ± SD, 1.84 ± 1.29) than the opioid group (mean ± SD, 2.46 ± 1.90; p = 0.01).","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Frants', 'Affiliation': 'From the Department of Otolaryngology-Head and Neck Surgery, New York University Grossman School of Medicine; and the Department of Population Health, Division of Biostatistics, New York University Langone Health.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Garber', 'Affiliation': 'From the Department of Otolaryngology-Head and Neck Surgery, New York University Grossman School of Medicine; and the Department of Population Health, Division of Biostatistics, New York University Langone Health.'}, {'ForeName': 'Marissa P', 'Initials': 'MP', 'LastName': 'Lafer', 'Affiliation': 'From the Department of Otolaryngology-Head and Neck Surgery, New York University Grossman School of Medicine; and the Department of Population Health, Division of Biostatistics, New York University Langone Health.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Gordon', 'Affiliation': 'From the Department of Otolaryngology-Head and Neck Surgery, New York University Grossman School of Medicine; and the Department of Population Health, Division of Biostatistics, New York University Langone Health.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Markey', 'Affiliation': 'From the Department of Otolaryngology-Head and Neck Surgery, New York University Grossman School of Medicine; and the Department of Population Health, Division of Biostatistics, New York University Langone Health.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Otolaryngology-Head and Neck Surgery, New York University Grossman School of Medicine; and the Department of Population Health, Division of Biostatistics, New York University Langone Health.'}, {'ForeName': 'Binhuan', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'From the Department of Otolaryngology-Head and Neck Surgery, New York University Grossman School of Medicine; and the Department of Population Health, Division of Biostatistics, New York University Langone Health.'}, {'ForeName': 'Judy W', 'Initials': 'JW', 'LastName': 'Lee', 'Affiliation': 'From the Department of Otolaryngology-Head and Neck Surgery, New York University Grossman School of Medicine; and the Department of Population Health, Division of Biostatistics, New York University Langone Health.'}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000007427'] 1724,33328137,Utilization of a quality reporting system to increase faculty participation in resident operative assessment.,"BACKGROUND A quality collaborative across our hospital system was initiated to track surgical outcomes. We sought to determine whether incorporating a resident operative performance assessment into this quality collaborative would increase the quantity and quality of these assessments and impact relevant milestones. METHODS A resident operative assessment was added to a quality reporting system required to be completed by faculty at the completion of 2 operations. Three milestones directly related to operative performance were analyzed-Patient Care 3, Medical Knowledge 2, and Interpersonal and Communication Skills 3. Residents were divided in 2 groups: quality collaborative (≥10 operative assessments) and no quality collaborative (<10 operative assessments). Milestones from Spring 2019 and Fall 2019 were analyzed. RESULTS Faculty participation was 86% with 407 assessments completed from February to October 2019. A difference in the rate of change in resident performance for Patient Care 3 (+0.95 vs +0.55; P = .04) and Interpersonal and Communication Skills 3 (+1.05 vs +0.52; P = .02) was observed for those residents in the quality collaborative group (n = 20) compared with baseline data. CONCLUSION Addition of an operative assessment to a mandatory quality collaborative increases faculty participation and impacts resident milestone determination. These findings highlight opportunities to find innovative and efficient methods to improve faculty engagement.",2021,"A difference in the rate of change in resident performance for Patient Care 3 (+0.95 vs +0.55; P = .04) and Interpersonal and Communication Skills 3 (+1.05 vs +0.52; P = .02) was observed for those residents in the quality collaborative group (n = 20) compared with baseline data. ",[],['quality collaborative (≥10 operative assessments) and no quality collaborative'],['Interpersonal and Communication Skills'],[],"[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0870313', 'cui_str': 'Communication skills'}]",,0.0581113,"A difference in the rate of change in resident performance for Patient Care 3 (+0.95 vs +0.55; P = .04) and Interpersonal and Communication Skills 3 (+1.05 vs +0.52; P = .02) was observed for those residents in the quality collaborative group (n = 20) compared with baseline data. ","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Naples', 'Affiliation': 'Department of General Surgery, Cleveland Clinic, Cleveland, OH. Electronic address: naplesr2@ccf.org.'}, {'ForeName': 'Judith C', 'Initials': 'JC', 'LastName': 'French', 'Affiliation': 'Department of General Surgery, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Jonah D', 'Initials': 'JD', 'LastName': 'Thomas', 'Affiliation': 'Department of General Surgery, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Cathleen', 'Initials': 'C', 'LastName': 'Khandelwal', 'Affiliation': 'Department of General Surgery, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Rosen', 'Affiliation': 'Department of General Surgery, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Lipman', 'Affiliation': 'Department of General Surgery, Cleveland Clinic, Cleveland, OH.'}]",Surgery,['10.1016/j.surg.2020.11.014'] 1725,33335310,The effects of FAAH inhibition on the neural basis of anxiety-related processing in healthy male subjects: a randomized clinical trial.,"Acute pharmacological inhibition of the anandamide-degrading enzyme, fatty acid amide hydrolase (FAAH), prolongs the regulatory effects of endocannabinoids and reverses the stress-induced anxiety state in a cannabinoid receptor-dependent manner. However, the neural systems underlying this modulation are poorly understood. A single site, randomized, double-blind, placebo-controlled, parallel study was conducted with 43 subjects assigned to receive once daily dosing of either placebo (n = 21) or JNJ-42165279 (100 mg) (n = 22) for 4 consecutive days. Pharmacodynamic effects were assessed on the last day of dosing and included evaluation of brain activation patterns using BOLD fMRI during an (1) emotion face-processing task, (2) inspiratory breathing load task, and (3) fear conditioning and extinction task. JNJ-42165279 attenuated activation in the amygdala, bilateral anterior cingulate, and bilateral insula during the emotion face-processing task consistent with effects previously observed with anxiolytic agents. Higher levels of anandamide were associated with greater attenuation in bilateral anterior cingulate and left insula. JNJ-42165279 increased the activation during anticipation of an aversive interoceptive event in the anterior cingulate and bilateral anterior insula and right inferior frontal cortex. JNJ-42165279 did not affect fear conditioning or within-session extinction learning as evidenced by a lack of differences on a subjective and neural circuit level. Taken together, these results support the hypothesis that JNJ-42165279 at this dose shares some effects with existing anxiolytic agents in dampening response to emotional stimuli but not responses to conditioned fear.",2021,JNJ-42165279 increased the activation during anticipation of an aversive interoceptive event in the anterior cingulate and bilateral anterior insula and right inferior frontal cortex.,"['43 subjects', 'healthy male subjects']","['placebo', 'FAAH inhibition']","['subjective and neural circuit level', 'Pharmacodynamic effects', 'activation during anticipation of an aversive interoceptive event', 'brain activation patterns using BOLD fMRI during an (1) emotion face-processing task, (2) inspiratory breathing load task, and (3) fear conditioning and extinction task']","[{'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0531004', 'cui_str': 'fatty acid amide hydrolase'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}]",,0.120937,JNJ-42165279 increased the activation during anticipation of an aversive interoceptive event in the anterior cingulate and bilateral anterior insula and right inferior frontal cortex.,"[{'ForeName': 'Martin P', 'Initials': 'MP', 'LastName': 'Paulus', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla, CA, USA. mpaulus@laureateinstitute.org.'}, {'ForeName': 'Murray B', 'Initials': 'MB', 'LastName': 'Stein', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Alan N', 'Initials': 'AN', 'LastName': 'Simmons', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Victoria B', 'Initials': 'VB', 'LastName': 'Risbrough', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Halter', 'Affiliation': 'Janssen Research & Development, LLC, San Diego, CA, USA.'}, {'ForeName': 'Sandra R', 'Initials': 'SR', 'LastName': 'Chaplan', 'Affiliation': 'Janssen Research & Development, LLC, San Diego, CA, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00936-w'] 1726,33337319,Impact of three-dimensional vision in laparoscopic partial nephrectomy for renal tumors.,"OBJECTIVE To compare three-dimensional (3D) with standard two-dimensional (2D) laparoscopic partial nephrectomy (LPN) with respect to intra- and postoperative outcomes. MATERIAL AND METHODS Data from 112 patients who underwent transperitoneal LPN from 2012 to 2014 by a single experienced surgeon were collected. Sixty patients (group 1) underwent conventional 2D LPN and 52 patients (group 2) 3D LPN. Perioperative patient, procedure, and tumor data were recorded. The follow-up period was 1-5 years. RESULTS The two groups had similar patient age (p=0.834) and body mass index (p=0.141). The total laparoscopy time (LT) was shorter in group 2 (119.0 vs. 106.0 min; p=0.009). Warm ischemia times (WITs) were also shorter in group 2 (11.5 vs. 10.0 min; p=0.032). The estimated blood loss (EBL) (350.0 vs. 250.0 mL; p<0.001) and hemoglobin (Hb) decrease (1.55 vs. 1.35 g/dL; p=0.536) were lower in the 3D LPN group. Creatinine (0 vs. 0 g/dL; p=0.610) increase and estimated glomerular filtration rate (eGFR) decrease (0 vs. 0 mL/min/1.73 m 2 ; p=0.553) did not demonstrate statistically significant differences. Duration of hospitalization (7 vs. 7 days; p=0.099) and complication rates (p=0.559) were similar between the two groups. CONCLUSION The new-generation 3D laparoscope has a great impact on significant LPN intraoperative parameters, mainly LT, WIT, and EBL. Hb decrease is also in favor of 3D vision, although not dramatically altered. Therefore, 3D LPN appears to be superior to conventional 2D LPNs.",2021,Warm ischemia times (WITs) were also shorter in group 2 (11.5 vs. 10.0 min; p=0.032).,"['Sixty patients (group 1) underwent', 'Data from 112 patients who underwent transperitoneal LPN from 2012 to 2014 by a single experienced surgeon were collected', 'laparoscopic partial nephrectomy for renal tumors']","['conventional 2D LPN', 'dimensional (3D) with standard two-dimensional (2D) laparoscopic partial nephrectomy (LPN']","['estimated blood loss (EBL', 'complication rates', 'total laparoscopy time (LT', 'Perioperative patient, procedure, and tumor data', 'Creatinine', 'glomerular filtration rate (eGFR) decrease ', 'Duration of hospitalization', 'hemoglobin (Hb) decrease', 'Warm ischemia times (WITs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0205501', 'cui_str': 'Transperitoneal approach'}, {'cui': 'C1144661', 'cui_str': 'Laparoscopic partial nephrectomy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0022665', 'cui_str': 'Neoplasm of kidney'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1144661', 'cui_str': 'Laparoscopic partial nephrectomy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C1563923', 'cui_str': 'Warm Ischemic Time'}]",60.0,0.0773435,Warm ischemia times (WITs) were also shorter in group 2 (11.5 vs. 10.0 min; p=0.032).,"[{'ForeName': 'Theodoros', 'Initials': 'T', 'LastName': 'Tokas', 'Affiliation': 'Department of Urology and Andrology, General Hospital Hall i.T., Hall in Tirol, Austria.'}, {'ForeName': 'Margaritis', 'Initials': 'M', 'LastName': 'Avgeris', 'Affiliation': 'Department of Biochemistry and Molecular Biology, Faculty of Biology, University of Athens, Athens, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Leotsakos', 'Affiliation': 'Department of Urology and Andrology, General Hospital Hall i.T., Hall in Tirol, Austria.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Nagele', 'Affiliation': 'Department of Urology and Andrology, General Hospital Hall i.T., Hall in Tirol, Austria.'}, {'ForeName': 'Ali Serdar', 'Initials': 'AS', 'LastName': 'Gözen', 'Affiliation': 'Department of Urology, SLK-Kliniken, University of Heidelberg, Heilbronn, Germany.'}]",Turkish journal of urology,['10.5152/tud.2020.20439'] 1727,33336381,Bumetanide for autism: Open-label trial in six children.,"AIM Bumetanide, a diuretic agent, that reduces intracellular chloride-thereby reinforcing GABAergic inhibition-has been reported to improve core symptoms of autism in children. Given the positive results reported from French trials of bumetanide in children with autism, we decided to evaluate its effects in a small-scale pilot study, in advance of a larger randomised controlled study (RCT). METHODS This was an open-label three-month trial of bumetanide on six children (five boys), aged 3-14 years with autism. Ratings according to the Parental Satisfaction Survey (PASS) were used after four and twelve weeks to assess symptom change. Blood electrolyte status was monitored. RESULTS Improvement in the PASS domain ""Communicative and cognitive abilities"" was marked or very marked in four children, and two had some improvements. Few negative side effects were reported. CONCLUSION Our small cohort responded well to bumetanide, particularly with regard to ""Communicative and cognitive abilities"". Taken with the evidence from larger-scale RCTs, we suggest that bumetanide should be considered for inclusion in ethically approved treatment/management trials for children with autism, subject to rigorous follow-up in large-scale RCTs.",2021,"RESULTS Improvement in the PASS domain ""Communicative and cognitive abilities"" was marked or very marked in four children and two had some improvements.","['autism in children', 'autism', 'six children (five boys), aged 3-14 years with autism', 'six children', 'children with autism']","['bumetanide', 'Bumetanide']","['PASS domain ""Communicative and cognitive abilities', 'Blood electrolyte status']","[{'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0006376', 'cui_str': 'Bumetanide'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0853360', 'cui_str': 'Blood electrolytes'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",4.0,0.0518526,"RESULTS Improvement in the PASS domain ""Communicative and cognitive abilities"" was marked or very marked in four children and two had some improvements.","[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Fernell', 'Affiliation': 'Gillberg Neuropsychiatry Centre, Institute of Neuroscience and Physiology, Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'Peik', 'Initials': 'P', 'LastName': 'Gustafsson', 'Affiliation': 'Child and Adolescent Psychiatry, Department of Clinical Sciences Lund, Medical Faculty, Lund University, Lund, Sweden.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Gillberg', 'Affiliation': 'Gillberg Neuropsychiatry Centre, Institute of Neuroscience and Physiology, Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15723'] 1728,33337693,Mountain Bike Racing Stimulates Osteogenic Bone Signaling and Ingesting Carbohydrate-Protein Compared With Carbohydrate-Only Prevents Acute Recovery Bone Resorption Dominance.,"ABSTRACT Oosthuyse, T, Bosch, AN, Kariem, N, and Millen, AME. Mountain bike racing stimulates osteogenic bone signaling and ingesting carbohydrate-protein compared with carbohydrate-only prevents acute recovery bone resorption dominance. J Strength Cond Res 35(2): 292-299, 2021-Mountain biking, unlike road cycling, includes vibrational accelerations but whether it stimulates osteogenic signaling remains unknown. Furthermore, exercise nutrition influences bone turnover, and the effect of ingesting protein during multiday racing was investigated. We measured plasma bone turnover markers, C-terminal telopeptide of type1-collagen (β-CTX) and N-terminal propeptides of type1-procollagen (P1NP), and osteocyte mechanosensory signaling factor, sclerostin (SOST), corrected for plasma volume change, before (pre-day 1) and 20-60 minutes after (post-day 3) a multiday mountain bike race in 18 male cyclists randomly assigned to ingest carbohydrate-only (CHO-only) or carbohydrate-with-casein protein hydrolysate (CHO-PRO) during racing. Fourteen cyclists (n = 7 per group) completed the race, and data were analyzed with p < 0.05 accepted as significant. Plasma SOST decreased similarly in both groups (mean ± SD, CHO-only: 877 ± 451 to 628 ± 473 pg·ml-1, p = 0.004; CHO-PRO: 888 ± 411 to 650 ± 443 pg·ml-1, p = 0.003), suggesting that osteocytes sense mountain biking as mechanical loading. However, the bone formation marker, P1NP, remained unchanged in both groups, whereas the bone resorption marker, β-CTX, increased in CHO-only (0.19 ± 0.034 to 0.31 ± 0.074 ng·ml-1, p = 0.0036) but remained unchanged in CHO-PRO (0.25 ± 0.079 to 0.26 ± 0.074 ng·ml-1, p = 0.95). Mountain bike racing does stimulate osteogenic bone signaling but bone formation is not increased acutely after multiday mountain biking; investigation for a delayed effect is warranted. The acute recovery increase in bone resorption with CHO-only is prevented by ingesting CHO-PRO during racing.",2021,Mountain bike racing does stimulate osteogenic bone signaling but bone formation is not increased acutely after multiday mountain biking; investigation for a delayed effect is warranted.,['18 male cyclists randomly assigned to'],"['Carbohydrate-Protein', 'ingest carbohydrate-only (CHO-only) or carbohydrate-with-casein protein hydrolysate (CHO-PRO', 'J Strength Cond Res XX(X']","['Plasma SOST', 'bone formation marker, P1NP', 'bone resorption', 'Acute Recovery Bone Resorption Dominance', 'bone resorption marker, β-CTX', 'plasma bone turnover markers, C-terminal telopeptide of type1-collagen (β-CTX) and N-terminal propeptides of type1-procollagen (P1NP), and osteocyte mechanosensory signaling factor, sclerostin (SOST), corrected for plasma volume change']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0033631', 'cui_str': 'protein hydrolysates'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1287621', 'cui_str': 'Eye dominance - finding'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0029432', 'cui_str': 'Osteocyte'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0032127', 'cui_str': 'Blood plasma volume'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",18.0,0.0199414,Mountain bike racing does stimulate osteogenic bone signaling but bone formation is not increased acutely after multiday mountain biking; investigation for a delayed effect is warranted.,"[{'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Oosthuyse', 'Affiliation': 'School of Physiology, Faculty of Health Sciences, University of the Witwatersrand, Medical School, Johannesburg, South Africa; and.'}, {'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Bosch', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Neezaam', 'Initials': 'N', 'LastName': 'Kariem', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Aletta M E', 'Initials': 'AME', 'LastName': 'Millen', 'Affiliation': 'School of Physiology, Faculty of Health Sciences, University of the Witwatersrand, Medical School, Johannesburg, South Africa; and.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003928'] 1729,33337689,The Effect of the Oral Contraceptive Cycle Phase on Exercise-Induced Muscle Damage After Eccentric Exercise in Resistance-Trained Women.,"ABSTRACT Romero-Parra, N, Rael, B, Alfaro-Magallanes, VM, Janse de Jonge, X, Cupeiro, R, and Peinado, AB; On Behalf of the IronFEMME Study Group. The effect of the oral contraceptive cycle phase on exercise-induced muscle damage after eccentric exercise in resistance-trained women. J Strength Cond Res 35(2): 353-359, 2021-To evaluate the influence of the active pill phase versus withdrawal phase of a monophasic oral contraceptive (OC) cycle on exercise-induced muscle damage and inflammation after eccentric resistance exercise. Eighteen resistance-trained female OC users (age: 25.6 ± 4.2 years, height: 162.4 ± 5.0 cm, and body mass: 58.1 ± 5.7 kg) performed an eccentric squat-based exercise during the active pill phase and withdrawal phase of their OC cycle. Muscle soreness, counter movement jump (CMJ), and blood markers of muscle damage and inflammation were evaluated before and postexercise (0, 2, 24, and 48 hours). Creatine kinase (CK) values were higher in the withdrawal (181.8 ± 89.8 U·L-1) than in the active pill phase (144.0 ± 39.7 U·L-1) (p < 0.001). The highest CK concentrations and muscle soreness values were observed 24 hours postexercise (217.9 ± 117.5 U·L-1 and 44.7 ± 19.7, respectively) compared with baseline (115.3 ± 37.4 U·L-1 and 4.4 ± 9.2, respectively; p < 0.001). In addition, a decrease in CMJ immediately postexercise (20.23 ± 4.6 cm) was observed in comparison with baseline (24.2 ± 6.1 cm), which was not yet recovered 24 hours postexercise (21.9 ± 5.9 cm; p < 0.001). No other phase or time effects were observed. An eccentric squat-based exercise session elicits muscle damage but no inflammation response in resistance-trained women. Furthermore, the highest CK concentrations observed in the withdrawal phase suggest that this phase might be more vulnerable to muscle damage and, therefore, less adequate to administer high training loads. However, the lack of differences in other muscle damage variables between OC phases does not warrant any guidance on the active pill versus withdrawal phase.",2021,Creatine kinase (CK) values were higher in the withdrawal (181.8 ± 89.8 U·L-1) than in the active pill phase (144.0 ± 39.7 U·L-1) (p < 0.001).,"['resistance-trained women', 'Eighteen resistance-trained female OC users (age: 25.6 ± 4.2 years, height: 162.4 ± 5.0 cm, and body mass: 58.1 ± 5.7 kg) performed an', 'Resistance-Trained Women']","['J Strength Cond Res XX(X', 'active pill phase versus withdrawal phase of a monophasic oral contraceptive (OC) cycle on exercise-induced muscle damage and inflammation after eccentric resistance exercise', 'eccentric squat-based exercise', 'Oral Contraceptive Cycle Phase on Exercise-Induced Muscle Damage', 'eccentric squat-based exercise session', 'eccentric exercise', 'Eccentric Exercise']","['highest CK concentrations and muscle soreness values', 'Muscle soreness, counter movement jump (CMJ), and blood markers of muscle damage and inflammation', 'Creatine kinase (CK) values', 'CMJ immediately postexercise', 'highest CK concentrations']","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0205186', 'cui_str': 'Monophasic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0151576', 'cui_str': 'Creatine phosphokinase increased'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0677601', 'cui_str': 'Counter'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0205548', 'cui_str': 'Stat'}]",,0.156929,Creatine kinase (CK) values were higher in the withdrawal (181.8 ± 89.8 U·L-1) than in the active pill phase (144.0 ± 39.7 U·L-1) (p < 0.001).,"[{'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Romero-Parra', 'Affiliation': 'LFE Research Group, Department of Health and Human Performance, Faculty of Physical Activity and Sport Sciences, Polytechnic University of Madrid (UPM), Madrid, Spain; and.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Rael', 'Affiliation': 'LFE Research Group, Department of Health and Human Performance, Faculty of Physical Activity and Sport Sciences, Polytechnic University of Madrid (UPM), Madrid, Spain; and.'}, {'ForeName': 'Víctor M', 'Initials': 'VM', 'LastName': 'Alfaro-Magallanes', 'Affiliation': 'LFE Research Group, Department of Health and Human Performance, Faculty of Physical Activity and Sport Sciences, Polytechnic University of Madrid (UPM), Madrid, Spain; and.'}, {'ForeName': 'Xanne', 'Initials': 'X', 'LastName': 'Janse de Jonge', 'Affiliation': 'School of Environmental and Life Sciences, Faculty of Science, the University of Newcastle (UON), Ourimbah, NSW, Australia.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Cupeiro', 'Affiliation': 'LFE Research Group, Department of Health and Human Performance, Faculty of Physical Activity and Sport Sciences, Polytechnic University of Madrid (UPM), Madrid, Spain; and.'}, {'ForeName': 'Ana B', 'Initials': 'AB', 'LastName': 'Peinado', 'Affiliation': 'LFE Research Group, Department of Health and Human Performance, Faculty of Physical Activity and Sport Sciences, Polytechnic University of Madrid (UPM), Madrid, Spain; and.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003897'] 1730,33342316,Guidelines for the design and conduct of human clinical trials on ingestion-time differences - chronopharmacology and chronotherapy - of hypertension medications.,"Current hypertension guidelines fail to provide a recommendation on when-to-treat, thus disregarding relevant circadian rhythms that regulate blood pressure (BP) level and 24 h patterning and medication pharmacokinetics and pharmacodynamics. The ideal purpose of ingestion-time (chronopharmacology, i.e. biological rhythm-dependent effects on the kinetics and dynamics of medications, and chronotherapy, i.e. the timing of pharmaceutical and other treatments to optimize efficacy and safety) trials should be to explore the potential impact of endogenous circadian rhythms on the effects of medications. Such investigations and outcome trials mandate adherence to the basic standards of human chronobiology research. In-depth review of the more than 150 human hypertension pharmacology and therapeutic trials published since 1974 that address the differential impact of upon-waking/morning versus at-bedtime/evening schedule of treatment reveals diverse protocols of sometimes suboptimal or defective design and conduct. Many have been ""time-of-day,"" i.e. morning versus evening, rather than circadian-time-based, and some relied on wake-time office BP rather than around-the-clock ambulatory BP measurements (ABPM). Additionally, most past studies have been of too small sample size and thus statistically underpowered. As of yet, there has been no consensual agreement on the proper design, methods and conduct of such trials. This Position Statement recommends ingestion-time hypertension trials to follow minimum guidelines: (i) Recruitment of participants should be restricted to hypertensive individuals diagnosed according to ABPM diagnostic thresholds and of a comparable activity/sleep routine. (ii) Tested treatment-times should be selected according to internal biological time, expressed by the awakening and bed times of the sleep/wake cycle. (iii) ABPM should be the primary or sole method of BP assessment. (iv) The minimum-required features for analysis of the ABPM-determined 24 h BP pattern ought to be the asleep (not ""nighttime"") BP mean and sleep-time relative BP decline , calculated in reference to the activity/rest cycle per individual. (v) ABPM-obtained BP means should be derived by the so-called adjusted calculation procedure, not by inaccurate arithmetic averages. (vi) ABPM should be performed with validated and calibrated devices at least hourly throughout two or more consecutive 24 h periods (48 h in total) to achieve the highest reproducibility of mean wake-time, sleep-time and 48 h BP values plus the reliable classification of dipping status. (vii) Calculation of minimum required sample size in adherence with proper statistical methods must be provided. (viii) Hypertension chronopharmacology and chronotherapy trials should preferably be randomized double-blind, randomized open-label with blinded-endpoint, or crossover in design, the latter with sufficient washout period between tested treatment-time regimens.",2021,"As of yet, there has been no consensual agreement on the proper design, methods and conduct of such trials.",[],[],"['BP mean and sleep-time relative BP decline', 'blood pressure (BP) level']",[],[],"[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0686856,"As of yet, there has been no consensual agreement on the proper design, methods and conduct of such trials.","[{'ForeName': 'Ramón C', 'Initials': 'RC', 'LastName': 'Hermida', 'Affiliation': 'Bioengineering & Chronobiology Laboratories; Atlantic Research Center for Information and Communication Technologies (atlanTTic), University of Vigo , Vigo, Spain.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Smolensky', 'Affiliation': 'Department of Biomedical Engineering, Cockrell School of Engineering, the University of Texas at Austin , Austin, Texas, USA.'}, {'ForeName': 'Horia', 'Initials': 'H', 'LastName': 'Balan', 'Affiliation': 'Department of Internal Medicine, ""Carol Davila"" University of Medicine and Pharmacy , Bucharest, Romania.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Castriotta', 'Affiliation': 'Department of Medicine; Division of Pulmonary, Critical Care and Sleep Medicine; Keck School of Medicine, University of Southern California , Los Angeles, California, USA.'}, {'ForeName': 'Juan J', 'Initials': 'JJ', 'LastName': 'Crespo', 'Affiliation': 'Bioengineering & Chronobiology Laboratories; Atlantic Research Center for Information and Communication Technologies (atlanTTic), University of Vigo , Vigo, Spain.'}, {'ForeName': 'Yaron', 'Initials': 'Y', 'LastName': 'Dagan', 'Affiliation': 'Applied Chronobiology Research Center, Tel-Hai Academic College, Israel; Human Biology Department, Haifa University , Israel.'}, {'ForeName': 'Sherine', 'Initials': 'S', 'LastName': 'El-Toukhy', 'Affiliation': 'Intramural Research Program, National Institute on Minority Health and Health Disparities, National Institutes of Health , Bethesda, Maryland, USA.'}, {'ForeName': 'José R', 'Initials': 'JR', 'LastName': 'Fernández', 'Affiliation': 'Bioengineering & Chronobiology Laboratories; Atlantic Research Center for Information and Communication Technologies (atlanTTic), University of Vigo , Vigo, Spain.'}, {'ForeName': 'Garret A', 'Initials': 'GA', 'LastName': 'FitzGerald', 'Affiliation': 'Institute for Translational Medicine and Therapeutics, Smilow Center for Translational Research, Perelman School of Medicine, University of Pennsylvania , Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Fujimura', 'Affiliation': 'Department of Clinical Pharmacology, Jichi Medical University , Tochigi, Japan.'}, {'ForeName': 'Yong-Jian', 'Initials': 'YJ', 'LastName': 'Geng', 'Affiliation': 'Department of Internal Medicine, McGovern School of Medicine, University of Texas Health Science Center at Houston , Houston, Texas, USA.'}, {'ForeName': 'Ramón G', 'Initials': 'RG', 'LastName': 'Hermida-Ayala', 'Affiliation': 'Chief Pharmacology Officer, Circadian Ambulatory Technology & Diagnostics (CAT&D) , Santiago de Compostela, Spain.'}, {'ForeName': 'Antonio P', 'Initials': 'AP', 'LastName': 'Machado', 'Affiliation': 'President, Update em Medicina , Lisboa, Portugal.'}, {'ForeName': 'Luiz', 'Initials': 'L', 'LastName': 'Menna-Barreto', 'Affiliation': 'Escola de Artes, Ciências e Humanidades, Grupo Multidisciplinar de Desenvolvimento e Ritmos Biológicos (GMDRB), Universidade de São Paulo , São Paulo, Brazil.'}, {'ForeName': 'Artemio', 'Initials': 'A', 'LastName': 'Mojón', 'Affiliation': 'Bioengineering & Chronobiology Laboratories; Atlantic Research Center for Information and Communication Technologies (atlanTTic), University of Vigo , Vigo, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Otero', 'Affiliation': 'Servicio de Nefrología, Complejo Hospitalario Universitario de Ourense, Estructura de Xestión Integrada de Ourense, Verín e O Barco de Valdeorras, Servicio Galego de Saúde (SERGAS) , Ourense, Spain.'}, {'ForeName': 'R Daniel', 'Initials': 'RD', 'LastName': 'Rudic', 'Affiliation': 'Department of Pharmacology & Toxicology, Augusta University , Augusta, Georgia, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Schernhammer', 'Affiliation': 'Department of Epidemiology, Harvard T.H Chan School of Public Health , Boston, Massachusetts, USA.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Skarke', 'Affiliation': 'Institute for Translational Medicine and Therapeutics, Smilow Center for Translational Research, Perelman School of Medicine, University of Pennsylvania , Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Tomoko Y', 'Initials': 'TY', 'LastName': 'Steen', 'Affiliation': 'Department of Microbiology and Immunology, School of Medicine, Georgetown University , Washington, DC, USA.'}, {'ForeName': 'Martin E', 'Initials': 'ME', 'LastName': 'Young', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Medicine, University of Alabama at Birmingham , Birmingham, Alabama, USA.'}, {'ForeName': 'Xiaoyun', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Respiratory and Critical Care Medicine Department, Sleep Medicine Center, Tianjin Chest Hospital , Tianjin, China.'}]",Chronobiology international,['10.1080/07420528.2020.1850468'] 1731,33341153,"Group-based parenting interventions to promote child development in rural Kenya: a multi-arm, cluster-randomised community effectiveness trial.","BACKGROUND Early childhood development (ECD) programmes can help address early disadvantages for the 43% of children younger than 5 years in low-income and middle-income countries who have compromised development. We aimed to test the effectiveness of two group-based delivery models for an integrated ECD responsive stimulation and nutrition education intervention using Kenya's network of community health volunteers. METHODS We implemented a multi-arm, cluster-randomised community effectiveness trial in three rural subcounties across 60 villages (clusters) in western Kenya. Eligible participants were mothers or female primary caregivers aged 15 years or older with children aged 6-24 months at enrolment. If married or in established relationships, fathers or male caregivers aged 18 years or older were also eligible. Villages were randomly assigned (1:1:1) to one of three groups: group-only delivery with 16 fortnightly sessions; mixed delivery combining 12 group sessions with four home visits; and a comparison group. Villages in the intervention groups were randomly assigned (1:1) to invite or not invite fathers and male caregivers to participate. Households were surveyed at baseline and immediately post-intervention. Assessors were masked. Primary outcomes were child cognitive and language development (score on the Bayley Scales of Infant Development third edition), socioemotional development (score on the Wolke scale), and parental stimulation (Home Observation for Measurement of the Environment inventory). Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, NCT03548558. FINDINGS Between Oct 1 and Nov 12, 2018, 1152 mother-child dyads were enrolled and randomly assigned (n=376 group-only intervention, n=400 mixed-delivery intervention, n=376 comparison group). At the 11-month endline survey (Aug 5-Oct 31, 2019), 1070 households were assessed for the primary outcomes (n=346 group only, n=373 mixed delivery, n=351 comparison). Children in group-only villages had higher cognitive (effect size 0·52 SD [95% CI 0·21-0·83]), receptive language (0·42 SD [0·08-0·77]), and socioemotional scores (0·23 SD [0·03-0·44]) than children in comparison villages at endline. Children in mixed-delivery villages had higher cognitive (0·34 SD [0·05-0·62]) and socioemotional scores (0·22 SD [0·05-0·38]) than children in comparison villages; there was no difference in language scores. Parental stimulation also improved for group-only (0·80 SD [0·49-1·11]) and mixed-delivery villages (0·77 SD [0·49-1·05]) compared with the villages in the comparison group. Including fathers in the intervention had no measurable effect on any of the primary outcomes. INTERPRETATION Parenting interventions delivered by trained community health volunteers in mother-child groups can effectively promote child development in low-resource settings and have great potential for scalability. FUNDING Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health.",2021,Children in group-only villages had higher cognitive (effect size 0·52 SD,"['children younger than 5 years in low-income and middle-income countries who have compromised development', 'fathers or male caregivers aged 18 years or older were also eligible', 'Eligible participants were mothers or female primary caregivers aged 15 years or older with children aged 6-24 months at enrolment', 'three rural subcounties across 60 villages (clusters) in western Kenya', '1070 households were assessed for the primary outcomes (n=346 group only, n=373 mixed delivery, n=351 comparison', 'Between Oct 1 and Nov 12, 2018, 1152 mother-child dyads', ""Kenya's network of community health volunteers""]","['integrated ECD responsive stimulation and nutrition education intervention', 'Group-based parenting interventions', 'group-only delivery with 16 fortnightly sessions; mixed delivery combining 12 group sessions with four home visits; and a comparison group']","['receptive language (0·42 SD [0·08-0·77]), and socioemotional scores', 'higher cognitive (effect size 0·52 SD', 'socioemotional scores', 'language scores', 'child cognitive and language development (score on the Bayley Scales of Infant Development third edition), socioemotional development (score on the Wolke scale), and parental stimulation (Home Observation for Measurement of the Environment inventory']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1319883', 'cui_str': 'Primary caregiver'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C1442824', 'cui_str': 'POU2F1 protein, human'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}]","[{'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023013', 'cui_str': 'Language Development'}, {'cui': 'C0451021', 'cui_str': 'Bayley scale of infant development'}, {'cui': 'C0441796', 'cui_str': 'Third edition'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",3.0,0.167599,Children in group-only villages had higher cognitive (effect size 0·52 SD,"[{'ForeName': 'Jill E', 'Initials': 'JE', 'LastName': 'Luoto', 'Affiliation': 'RAND Corporation, Santa Monica, CA, USA. Electronic address: jluoto@rand.org.'}, {'ForeName': 'Italo', 'Initials': 'I', 'LastName': 'Lopez Garcia', 'Affiliation': 'RAND Corporation, Santa Monica, CA, USA.'}, {'ForeName': 'Frances E', 'Initials': 'FE', 'LastName': 'Aboud', 'Affiliation': 'Department of Psychology, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Daisy R', 'Initials': 'DR', 'LastName': 'Singla', 'Affiliation': 'Department of Psychiatry, Sinai Health and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Lia C H', 'Initials': 'LCH', 'LastName': 'Fernald', 'Affiliation': 'Division of Community Health Sciences, School of Public Health, University of California, Berkeley, Berkeley, CA, USA.'}, {'ForeName': 'Helen O', 'Initials': 'HO', 'LastName': 'Pitchik', 'Affiliation': 'Division of Epidemiology, School of Public Health, University of California, Berkeley, Berkeley, CA, USA.'}, {'ForeName': 'Uzaib Y', 'Initials': 'UY', 'LastName': 'Saya', 'Affiliation': 'RAND Corporation, Santa Monica, CA, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Otieno', 'Affiliation': 'Safe Water and AIDS Project, Kisumu, Kenya.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Alu', 'Affiliation': 'Safe Water and AIDS Project, Kisumu, Kenya.'}]",The Lancet. Global health,['10.1016/S2214-109X(20)30469-1'] 1732,33346899,Effects of Different Applications of Tranexamic Acid on Perioperative Blood Transfusion Rate and Postoperative Pain in Unilateral Total Knee Arthroplasty.,"INTRODUCTION The current study was conducted to evaluate the effect of different applications of tranexamic acid (TXA) on perioperative blood transfusion rate and postoperative pain in unilateral total knee arthroplasty. METHODS This prospective study included a total of 102 patients undergoing unilateral total knee arthroplasty in our hospital from November 2017 to October 2019. On the basis of different TXA administration methods, these patients were randomly assigned to a surface treatment group (50 cases were treated with intraoperative spraying and drug-soaked gauze to cover the wound combined with local injection into the articular cavity) and control group (52 cases were given TXA by intravenous drip combined with local injection into the articular cavity) by random number table method. Clinical data were recorded and evaluated in the two groups. A total of five surgeons participated in the study. RESULTS In the surface treatment group, the operation time, hospital stay, tourniquet time, and blood transfusion rate were significant lower compared with the control group, and there was no significant difference in the incision length between the two groups. Our results showed that intraoperative blood loss, postoperative drainage, postoperative blood loss, total blood loss, and the incidence of deep venous thrombosis in the surface treatment group were significantly lower than those in the control group. Our results demonstrated that the surface treatment group reported significantly lower degree of pain compared with the control group at 1 day and 3 days after the operation. However, 7 days after the operation, the degree of pain in the surface treatment group did not differ significantly from that in the control group. In addition, the results of blood coagulation indexes showed that the values of prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (Fib), D-dimer (D-D), and hemoglobin (HGB) in the surface treatment group did not differ significantly from those in the control group before the operation (P > 0.05). CONCLUSION In terms of applications of TXA, the method of intraoperative spraying and drug-soaked gauze covering the wound combined with local injection into the articular cavity can reduce the amount of bleeding and the rate of blood transfusion, and alleviate the degree of pain with high safety profile.",2021,Our results demonstrated that the surface treatment group reported significantly lower degree of pain compared with the control group at 1 day and 3 days after the operation.,"['unilateral total knee arthroplasty', '102 patients undergoing unilateral total knee arthroplasty in our hospital from November 2017 to October 2019', 'Unilateral Total Knee Arthroplasty', 'A total of five surgeons participated in the study']","['Tranexamic Acid', 'intraoperative spraying and drug-soaked gauze to cover the wound combined with local injection into the articular cavity) and control group (52 cases were given TXA by intravenous drip combined with local injection into the articular cavity', 'TXA', 'tranexamic acid (TXA']","['degree of pain', 'operation time, hospital stay, tourniquet time, and blood transfusion rate', 'blood coagulation indexes', 'prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (Fib), D-dimer (D-D), and hemoglobin (HGB', 'perioperative blood transfusion rate and postoperative pain', 'Perioperative Blood Transfusion Rate and Postoperative Pain', 'incision length', 'intraoperative blood loss, postoperative drainage, postoperative blood loss, total blood loss, and the incidence of deep venous thrombosis']","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0204774', 'cui_str': 'Soak'}, {'cui': 'C0590323', 'cui_str': 'Gauzes'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0502723', 'cui_str': 'Structure of joint cavity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C1621368', 'cui_str': 'Drip Infusions'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0428724', 'cui_str': 'Duration of tourniquet inflation'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}]",102.0,0.0239823,Our results demonstrated that the surface treatment group reported significantly lower degree of pain compared with the control group at 1 day and 3 days after the operation.,"[{'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopaedics, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Desi', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': 'Department of Orthopaedics, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': 'Department of Orthopaedics, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Wen', 'Affiliation': 'Department of Orthopaedics, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China. wenliang@ccmu.edu.cn.'}]",Advances in therapy,['10.1007/s12325-020-01596-4'] 1733,33350863,Inhibition of IL-13: A New Pathway for Atopic Dermatitis.,"Dupilumab, a monoclonal antibody against the common receptor of interleukin (IL)-4 and IL-13, was the first biologic therapy approved in Canada for treatment of moderate-to-severe atopic dermatitis (AD). While it is considered safe and effective, dupilumab is not universally effective and 8%-38% of patients develop conjunctivitis, while some patients develop head and neck dermatitis. Thus, new therapeutic options are warranted. While both IL-4 and IL-13 play important roles in the pathogenesis of AD, it has been recently demonstrated that IL-13 is the primary upregulated cytokine in AD skin biopsy samples. A placebo-controlled phase 2b clinical trial evaluating the efficacy and safety of lebrikizumab, an IL-13 inhibitor, in AD demonstrated that, at 16 weeks, Eczema Area and Severity Index (EASI) 75 and Investigator's Global Assessment (IGA) 0/1 were achieved by 60.6% and 44.6% of patients taking lebrikizumab at its highest dose (vs 24.3% and 15.3% of patients taking placebo, respectively). Moreover, treatment with lebrikizumab was associated with rapid improvement of pruritus and low rates of conjunctivitis (1.4%-3.8%). Another IL-13 monoclonal antibody, tralokinumab, was evaluated for safety and efficacy in moderate-to-severe AD. By week 12, among adults receiving 300 mg tralokinumab, 42.5% achieved EASI-75 and 26.7% achieved IGA 0/1 score (vs 15.5% and 11.8% in the placebo group, respectively). Both lebrikizumab and tralokinumab demonstrated acceptable safety profiles in AD (and non-AD) trials with adverse events often being comparable between treatment and control groups. Thus, IL-13 inhibitors may provide a safe and effective treatment alternative for patients with moderate-to-severe AD.",2020,"By week 12, among adults receiving 300 mg tralokinumab, 42.5% achieved EASI-75 and 26.7% achieved IGA 0/1 score (vs 15.5% and 11.8% in the placebo group, respectively).","['Atopic Dermatitis', 'patients with moderate-to-severe AD']","['placebo', 'lebrikizumab and tralokinumab', 'IL-13', 'lebrikizumab']","['safety and efficacy', 'pruritus and low rates of conjunctivitis', 'IGA 0/1 score', ""Eczema Area and Severity Index (EASI) 75 and Investigator's Global Assessment (IGA""]","[{'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2981360', 'cui_str': 'lebrikizumab'}, {'cui': 'C3658667', 'cui_str': 'tralokinumab'}, {'cui': 'C0214743', 'cui_str': 'Interleukin 13'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009763', 'cui_str': 'Conjunctivitis'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0796138,"By week 12, among adults receiving 300 mg tralokinumab, 42.5% achieved EASI-75 and 26.7% achieved IGA 0/1 score (vs 15.5% and 11.8% in the placebo group, respectively).","[{'ForeName': 'Kayadri', 'Initials': 'K', 'LastName': 'Ratnarajah', 'Affiliation': '12369 Faculty of Medicine, Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Le', 'Affiliation': '54473 Division of Dermatology, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Anastasiya', 'Initials': 'A', 'LastName': 'Muntyanu', 'Affiliation': '54473 Division of Dermatology, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Mathieu', 'Affiliation': 'Division of Dermatology, Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Nigen', 'Affiliation': 'Division of Dermatology, Maisonneuve-Rosemont Hospital, Montreal, QC, Canada.'}, {'ForeName': 'Ivan V', 'Initials': 'IV', 'LastName': 'Litvinov', 'Affiliation': '54473 Division of Dermatology, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Carolyn S', 'Initials': 'CS', 'LastName': 'Jack', 'Affiliation': '54473 Division of Dermatology, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Netchiporouk', 'Affiliation': '54473 Division of Dermatology, McGill University Health Centre, Montreal, QC, Canada.'}]",Journal of cutaneous medicine and surgery,['10.1177/1203475420982553'] 1734,33349055,Efficacy of attachment-based family therapy compared to treatment as usual for suicidal ideation in adolescents with MDD.,"Attachment-Based Family Therapy (ABFT) is the only empirically supported family therapy model designed to treat adolescent depression, including those at risk for suicide, and their families. ABFT aims to repair interpersonal ruptures and rebuild an emotionally protective parent-child relationship. To study the effectiveness of ABFT compared with Treatment as Usual (TAU) in reducing suicidal ideation in clinically depressed adolescents. Sixty adolescents (86.7% girls), aged 13 to 18 years ( M  = 14.9), with major depressive disorder referred to two CAMHS were randomized to receive 16 weeks of ABFT or TAU. ABFT consisted of weekly therapy sessions according to the treatment manual. Suicidal ideation was measured with the Suicidal Ideation Questionnaire-Junior at 4, 6, 8, 10, 12, 14, and 16 weeks. Linear mixed models were fitted to test our hypothesis, time was the only factor to have a significant effect on suicidal ideation t (31.05) = -3.32, p  < .01. Participants in both treatment groups reported significantly reduced suicidal ideation, but the majority were still in the clinical range after 16 weeks of treatment. ABFT was not associated with more favorable outcomes than TAU. Findings must be interpreted with caution given the study limitations.",2021,"Participants in both treatment groups reported significantly reduced suicidal ideation, but the majority were still in the clinical range after 16 weeks of treatment.","['Sixty adolescents (86.7% girls), aged 13 to 18\u2009years ( M \u2009=\u200914.9), with major depressive disorder referred to two CAMHS', 'adolescents with MDD', 'clinically depressed adolescents']","['ABFT or TAU', 'Usual (TAU', 'Attachment-Based Family Therapy (ABFT', 'ABFT', 'attachment-based family therapy']","['Suicidal Ideation Questionnaire-Junior', 'suicidal ideation', 'Suicidal ideation']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C1269683', 'cui_str': 'Major depressive disorder'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}]","[{'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015618', 'cui_str': 'Family therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0360945,"Participants in both treatment groups reported significantly reduced suicidal ideation, but the majority were still in the clinical range after 16 weeks of treatment.","[{'ForeName': 'Luxsiya', 'Initials': 'L', 'LastName': 'Waraan', 'Affiliation': 'Division of Mental Health Services, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Erling W', 'Initials': 'EW', 'LastName': 'Rognli', 'Affiliation': 'Department of Psychology, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Nikolai Olavi', 'Initials': 'NO', 'LastName': 'Czajkowski', 'Affiliation': 'PROMENTA Research Center, Department of Psychology, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Mehlum', 'Affiliation': 'National Centre for Suicide Research and Prevention, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Aalberg', 'Affiliation': 'Division of Mental Health Services, Akershus University Hospital, Lørenskog, Norway.'}]",Clinical child psychology and psychiatry,['10.1177/1359104520980776'] 1735,33352035,Direct Switch from Tiotropium to Indacaterol/Glycopyrronium in Chronic Obstructive Pulmonary Disease Patients in Korea.,"BACKGROUND Many chronic obstructive pulmonary disease (COPD) patients receiving monotherapy continue to experience symptoms, exacerbations and poor quality of life. This study aimed to assess the efficacy and safety of direct switch from once-daily tiotropium (TIO) 18 μg to indacaterol/glycopyrronium (IND/GLY) 110/50 μg once-daily in COPD patients in Korea. METHODS This was a randomized, open-label, parallel group, 12-week trial in mild-to-moderate COPD patients who received TIO 18 μg once-daily for ≥12 weeks prior to study initiation. Patients aged ≥40 years, with predicted postbronchodilator forced expiratory volume in 1 second (FEV1) ≥50%, post-bronchodilator FEV1/forced vital capacity <0.7 and smoking history of ≥10 pack-years were included. Eligible patients were randomized in a 1:1 ratio to either IND/GLY or TIO. The primary objective was to demonstrate superiority of IND/GLY over TIO in pre-dose trough FEV1 at week 12. Secondary endpoints included transition dyspnea index (TDI) focal score, COPD assessment test (CAT) total score, and rescue medication use following the 12-week treatment, and safety assessment. RESULTS Of the 442 patients screened, 379 were randomized and 347 completed the study. IND/GLY demonstrated superiority in pre-dose trough FEV1 versus TIO at week 12 (least squares mean treatment difference [Δ], 50 mL; p=0.013). Also, numerical improvements were observed with IND/GLY in the TDI focal score (Δ, 0.31), CAT total score (Δ, -0.81), and rescue medication use (Δ, -0.09 puffs/day). Both treatments were well tolerated by patients. CONCLUSION A direct switch from TIO to IND/GLY provided improvements in lung function and other patient-reported outcomes with an acceptable safety profile in patients with mild-to-moderate airflow limitation.",2021,Numerical improvements were also observed with IND/,"['patients with mild-to-moderate airflow limitation', 'mild-to-moderate COPD patients who received TIO 18 μg q.d', 'Eligible patients', 'Patients aged ≥40 years, with predicted post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥50%, post-bronchodilator FEV1/forced vital capacity (FVC) <0.7 and smoking history of ≥10 pack-years were included', 'COPD patients in Korea', '442 patients screened, 379 were randomized and 347 completed the study', 'COPD patients from Korea', 'chronic obstructive pulmonary disease (COPD) patients receiving']","['tiotropium', 'IND/GLY or TIO', 'indacaterol/glycopyrronium', 'direct switch from once-daily (q.d.) tiotropium (TIO', 'monotherapy', 'IND/GLY']","['transition dyspnoea index (TDI) focal score, COPD assessment test (CAT) total score, and rescue medication use following 12-week treatment, among others and safety assessment', 'efficacy and safety', 'tolerated', 'GLY in TDI focal score (Δ,0.31), CAT total score (Δ,-0.81) and rescue medication use', 'lung function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C1277691', 'cui_str': 'Pack years'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",379.0,0.148334,Numerical improvements were also observed with IND/,"[{'ForeName': 'Sang Haak', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': ""Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Chin Kook', 'Initials': 'CK', 'LastName': 'Rhee', 'Affiliation': ""Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Kwangha', 'Initials': 'K', 'LastName': 'Yoo', 'Affiliation': 'Division of Pulmonary, Allergy and Critical Care Medicine, Konkuk University Hospital, Konkuk University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jeong Woong', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'Division of Pulmonology, Allergy and Critical Care, Department of Internal Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Suk Joong', 'Initials': 'SJ', 'LastName': 'Yong', 'Affiliation': 'Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea.'}, {'ForeName': 'Jusang', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Taehoon', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Republic of Korea.'}, {'ForeName': 'Seong Yong', 'Initials': 'SY', 'LastName': 'Lim', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ji-Hyun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, CHA Bundang Medical Center, CHA University, Seongnam, Republic of Korea.'}, {'ForeName': 'Hye Yun', 'Initials': 'HY', 'LastName': 'Park', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Minyoung', 'Initials': 'M', 'LastName': 'Moon', 'Affiliation': 'Novartis Korea Ltd., Seoul, Republic of Korea.'}, {'ForeName': 'Ki-Suck', 'Initials': 'KS', 'LastName': 'Jung', 'Affiliation': 'Division of Pulmonary, Allergy and Critical Care Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Republic of Korea.'}]",Tuberculosis and respiratory diseases,['10.4046/trd.2020.0109'] 1736,33355478,"Adjunctive Garcinia mangostana Linn. (Mangosteen) Pericarp for Schizophrenia: A 24-Week Double-blind, Randomized, Placebo Controlled Efficacy Trial: Péricarpe d'appoint Garcinia mangostana Linn (mangoustan) pour la schizophrénie : un essai d'efficacité de 24 semaines, à double insu, randomisé et contrôlé par placebo.","OBJECTIVES Garcinia mangostana Linn. (""mangosteen"") pericarp contains bioactive compounds that may target biological pathways implicated in schizophrenia. We conducted a double-blind randomized placebo-controlled trial evaluating the efficacy of adjunctive mangosteen pericarp, compared to placebo, in the treatment of schizophrenia. METHODS People diagnosed with schizophrenia or schizoaffective disorder ( Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition ), recruited across 2 sites (Brisbane and Victoria, Australia), were randomized to receive 24 weeks of adjunctive mangosteen pericarp (1,000 mg/day) or matched placebo. The primary outcome measure was the Positive and Negative Symptom Scale total score. Secondary outcomes included positive and negative symptoms, general psychopathology, clinical global severity and improvement, participant reported overall improvement, depressive symptoms, functioning, quality of life, and safety data at 24 and 28 weeks (4 weeks postdiscontinuation). Data were collected from July 2016 to February 2019. RESULTS Baseline assessments were conducted on 148 people (mangosteen = 74, placebo = 74); data analyses were conducted on 136 (92%) participants with postbaseline data. The treatment group had significantly higher symptom severity compared to placebo, and both groups significantly improved on all symptom, functioning, and quality of life measures over time. No between-group differences were found for the rate of change between baseline and 24 or 28 weeks. CONCLUSION Despite promising preclinical and clinical work, our results do not support mangosteen pericarp extract as an adjunctive treatment for schizophrenia or schizoaffective disorder.",2021,"The treatment group had significantly higher symptom severity compared to placebo, and both groups significantly improved on all symptom, functioning, and quality of life measures over time.","['Data were collected from July 2016 to February 2019', '148 people (mangosteen = 74, placebo = 74); data analyses were conducted on 136 (92%) participants with postbaseline data', 'People diagnosed with schizophrenia or schizoaffective disorder ( Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition ), recruited across 2 sites (Brisbane and Victoria, Australia', 'Schizophrenia']","['adjunctive mangosteen pericarp (1,000 mg/day) or matched placebo', 'placebo', ""Péricarpe d'appoint"", 'Garcinia mangostana Linn (mangoustan) pour la schizophrénie ', 'Placebo']","['rate of change', 'symptom severity', 'Positive and Negative Symptom Scale total score', 'positive and negative symptoms, general psychopathology, clinical global severity and improvement, participant reported overall improvement, depressive symptoms, functioning, quality of life, and safety data', 'all symptom, functioning, and quality of life measures']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0950008', 'cui_str': 'Mangosteen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010992', 'cui_str': 'Data Analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0950008', 'cui_str': 'Mangosteen'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.627497,"The treatment group had significantly higher symptom severity compared to placebo, and both groups significantly improved on all symptom, functioning, and quality of life measures over time.","[{'ForeName': 'Alyna', 'Initials': 'A', 'LastName': 'Turner', 'Affiliation': '2104Deakin University, IMPACT-the Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Barwon Health, Geelong, Australia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Baker', 'Affiliation': '90131Queensland Centre for Mental Health Research, The Park Centre for Mental Health, Wacol, Australia.'}, {'ForeName': 'Olivia M', 'Initials': 'OM', 'LastName': 'Dean', 'Affiliation': '2104Deakin University, IMPACT-the Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Barwon Health, Geelong, Australia.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Walker', 'Affiliation': '2104Deakin University, IMPACT-the Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Barwon Health, Geelong, Australia.'}, {'ForeName': 'Seetal', 'Initials': 'S', 'LastName': 'Dodd', 'Affiliation': '2104Deakin University, IMPACT-the Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Barwon Health, Geelong, Australia.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Cotton', 'Affiliation': 'Centre for Youth Mental Health, The University of Melbourne, Parkville, Australia.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Scott', 'Affiliation': '90131Queensland Centre for Mental Health Research, The Park Centre for Mental Health, Wacol, Australia.'}, {'ForeName': 'Bianca E', 'Initials': 'BE', 'LastName': 'Kavanagh', 'Affiliation': '2104Deakin University, IMPACT-the Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Barwon Health, Geelong, Australia.'}, {'ForeName': 'Melanie M', 'Initials': 'MM', 'LastName': 'Ashton', 'Affiliation': '2104Deakin University, IMPACT-the Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Barwon Health, Geelong, Australia.'}, {'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Brown', 'Affiliation': '2104Deakin University, IMPACT-the Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Barwon Health, Geelong, Australia.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McGrath', 'Affiliation': '90131Queensland Centre for Mental Health Research, The Park Centre for Mental Health, Wacol, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berk', 'Affiliation': '2104Deakin University, IMPACT-the Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Barwon Health, Geelong, Australia.'}]",Canadian journal of psychiatry. Revue canadienne de psychiatrie,['10.1177/0706743720982437'] 1737,33353772,Re: Health Related Quality of Life of Patients with Bladder Cancer in the RAZOR Trial: A Multi-institutional Randomized Trial Comparing Robot Versus Open Radical Cystectomy.,,2021,,['Patients with Bladder Cancer in the RAZOR Trial'],['Robot Versus Open Radical Cystectomy'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C0336670', 'cui_str': 'Razor'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}]",[],,0.108752,,"[{'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Giannarini', 'Affiliation': 'Urology Unit, Santa Maria della Misericordia University Hospital, Udine, Italy. Electronic address: gianluca.giannarini@hotmail.it.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Valotto', 'Affiliation': 'Urology Unit, Santa Maria della Misericordia University Hospital, Udine, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Ficarra', 'Affiliation': 'Urologic Section, Gaetano Barresi Department of Adult and Paediatric Human Pathology, University of Messina, Messina, Italy.'}]",European urology,['10.1016/j.eururo.2020.12.006'] 1738,33361038,The specialized educational and psychological counseling in inflammatory bowel disease patients - a target or a challenge?,"BACKGROUND/AIMS Stress, in its various forms, plays an important role in the development and evolution of inflammatory bowel disease (IBD). For patients with IBD, the evidence related to the effects of various types of psychological therapies remains inconclusive. This study aimed to evaluate whether cognitive behavioral therapy, in combination with educational counseling, influenced disease activity and quality of life (QoL) among patients with IBD. MATERIALS AND METHODS We conducted a randomized controlled trial with 60 patients diagnosed with IBD. All patients completed the IBD questionnaire-32 (IBDQ-32) and the Big Five Inventory. Group A (experimental group) received specialized educational and psychological counseling (SEPC), and group B (control group) was treated according to the current medical practice. All patients were reassessed after 12 months. RESULTS After the SEPC, there was no improvement in disease activity as estimated by fecal calprotectin levels. However, the QoL of patients in group A was significantly improved. The highest mean difference between the initial and final IBDQ scores was found among patients whose main personality trait was openness to experience (48.58±28.80), and the lowest mean difference between these 2 scores was found among patients whose main personality trait was closedness to experience (3.33±2.97, p=0.009). CONCLUSION Although there was no improvement in disease activity after the SEPC, this therapy improved patients' QoL in terms of both emotional and social functions, especially among patients whose dominant personality trait was openness to experience or neuroticism.",2020,"Although there was no improvement in disease activity after the SEPC, this therapy improved patients' QoL in terms of both emotional and social functions, especially among patients whose dominant personality trait was openness to experience or neuroticism.","['patients with IBD', '60 patients diagnosed with IBD']","['specialized educational and psychological counseling (SEPC), and group B (control group', 'specialized educational and psychological counseling', 'cognitive behavioral therapy, in combination with educational counseling']","['fecal calprotectin levels', 'IBD questionnaire-32 (IBDQ-32', 'disease activity and quality of life (QoL', 'disease activity', 'initial and final IBDQ scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0474178', 'cui_str': 'Psychological counseling'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.0173747,"Although there was no improvement in disease activity after the SEPC, this therapy improved patients' QoL in terms of both emotional and social functions, especially among patients whose dominant personality trait was openness to experience or neuroticism.","[{'ForeName': 'Otilia', 'Initials': 'O', 'LastName': 'Gavrilescu', 'Affiliation': 'Department of Gastroenterology and Hepatology, Grigore T. Popa University of Medicine and Pharmacy Iasi, ""Sf. Spiridon"" Emergency University Hospital Iasi, Iasi, Romania.'}, {'ForeName': 'Cristina Cijevschi', 'Initials': 'CC', 'LastName': 'Prelipcean', 'Affiliation': 'Department of Gastroenterology and Hepatology, Grigore T. Popa University of Medicine and Pharmacy Iasi, ""Sf. Spiridon"" Emergency University Hospital Iasi, Iasi, Romania.'}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Dranga', 'Affiliation': 'Department of Gastroenterology and Hepatology, Grigore T. Popa University of Medicine and Pharmacy Iasi, ""Sf. Spiridon"" Emergency University Hospital Iasi, Iasi, Romania.'}, {'ForeName': 'Camelia', 'Initials': 'C', 'LastName': 'Soponaru', 'Affiliation': 'Alexandru Ioan Cuza University, School of Psychology and Education Sciences, Iasi, Romania.'}, {'ForeName': 'Catalina', 'Initials': 'C', 'LastName': 'Mihai', 'Affiliation': 'Department of Gastroenterology and Hepatology, Grigore T. Popa University of Medicine and Pharmacy Iasi, ""Sf. Spiridon"" Emergency University Hospital Iasi, Iasi, Romania.'}]",The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology,['10.5152/tjg.2020.19669'] 1739,33378764,Questioning the Consensus on Placebo and Nocebo Effects.,,2021,,[],[],[],[],[],[],,0.22279,,"[{'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Hardman', 'Affiliation': 'Department of Psychology, Bournemouth University, Poole, United Kingdom, dihardman@bournemouth.ac.uk.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Hutchinson', 'Affiliation': 'Department of Psychology, Manchester Metropolitan University, Manchester, United Kingdom.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Ongaro', 'Affiliation': 'Department of Anthropology, London School of Economics and Political Science, London, United Kingdom.'}]",Psychotherapy and psychosomatics,['10.1159/000513466'] 1740,33335715,"Protocol for a controlled, randomized, blind, clinical trial to assess the effects of anodal transcranial direct current stimulation dorsolateral prefrontal cortex associated with balance training using games in the postural balance of older people.","Aims: This study aims to evaluate the additional effect of anodal transcranial direct current stimulation (a-tDCS) applied on dorsolateral pré-frontal cortex on training postural balance with the use of video games in the aged. Methods: This is a blinded, randomized, controlled clinical trial protocol, with older people of both genders. Participants will be randomized into three training groups: Group 1 (videogame balance training), group 2 (videogame balance training associated with anodal tDCS), group 3 (videogame balance training associated with sham tDCS). The training will be carried out twice a week for four weeks, totaling eight sessions, and will be performed with the Nintendo Wii videogame console, using games that stimulate the postural balance associated with tDCS, with anode applied over the left dorsolateral prefrontal cortex and cathode on the contralateral supraorbital region at 2 mA for 20 minutes. The postural balance will be assessed using the Mini Test of the Balance Assessment System and posturography. Evaluations will be carried out before and after eight training sessions and 30 days after the end of treatment. Discussion: Some studies show favorable results from the use of video games in improving postural balance in older people; however, their effect does not remain long-term. TDCS associated with other therapies can potentiate and prolong the effects of these therapies owing to its ability to stimulate neurotrophins important for neurogenesis, facilitating tasks that require attention, and helping to consolidate learning and memory. The effect of the two associated techniques on balance has not yet been tested in this population. Registration: Brazilian Registry of Clinical Trials ID U1111-1213-4266; registered on 15 October 2018.",2020,This study aims to evaluate the additional effect of transcranial direct current stimulation (tDCS) on training postural balance with the use of video games in aged. ,"['elderly people', 'video games in aged', 'elderly people of both genders', 'U1111-1213-4266; registered on 15 October, 2018']","['transcranial direct current stimulation (tDCS', 'video games', 'transcranial direct current stimulation associated with balance training', 'Group 1 (videogame balance training), group 2 (videogame balance training associated with active tDCS), group 3 (videogame balance training associated with sham tDCS', 'TDCS']",['postural balance'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C1256755', 'cui_str': 'Postural balance'}]",,0.0395396,This study aims to evaluate the additional effect of transcranial direct current stimulation (tDCS) on training postural balance with the use of video games in aged. ,"[{'ForeName': 'Andre Issao', 'Initials': 'AI', 'LastName': 'Kunitake', 'Affiliation': 'Universidade Nove de Julho, Nove de Julho University, São Paulo, São Paulo, 01504-001, Brazil.'}, {'ForeName': 'João Carlos Ferrari', 'Initials': 'JCF', 'LastName': 'Corrêa', 'Affiliation': 'Universidade Nove de Julho, Nove de Julho University, São Paulo, São Paulo, 01504-001, Brazil.'}, {'ForeName': 'Klaine Silva', 'Initials': 'KS', 'LastName': 'Nascimento', 'Affiliation': 'Universidade Nove de Julho, Nove de Julho University, São Paulo, São Paulo, 01504-001, Brazil.'}, {'ForeName': 'Bianca Barioni Cardoso', 'Initials': 'BBC', 'LastName': 'de Oliveira', 'Affiliation': 'Universidade Nove de Julho, Nove de Julho University, São Paulo, São Paulo, 01504-001, Brazil.'}, {'ForeName': 'Natalia Maciel', 'Initials': 'NM', 'LastName': 'Muniz', 'Affiliation': 'Universidade Nove de Julho, Nove de Julho University, São Paulo, São Paulo, 01504-001, Brazil.'}, {'ForeName': 'Soraia Micaela', 'Initials': 'SM', 'LastName': 'Silva', 'Affiliation': 'Universidade Nove de Julho, Nove de Julho University, São Paulo, São Paulo, 01504-001, Brazil.'}, {'ForeName': 'Fernanda Ishida', 'Initials': 'FI', 'LastName': 'Corrêa', 'Affiliation': 'Universidade Nove de Julho, Nove de Julho University, São Paulo, São Paulo, 01504-001, Brazil.'}]",F1000Research,['10.12688/f1000research.25164.2'] 1741,32497602,"Editorial: Why JAACAP Published an ""Inconclusive"" Trial: Optimize, Optimize, Optimize Psychostimulant Treatment.","In this issue of the Journal, Blader et al. 1 report the results of a double-blind randomized controlled trial (RCT) aimed at assessing the comparative efficacy and tolerability of adjunctive risperidone (RISP), valproex sodium (DVPX), or placebo for aggressive behaviors in children (aged 6-12 years) with attention-deficit/hyperactivity disorder (ADHD) and comorbid oppositional defiant disorder (ODD) or conduct disorder (CD), as well as a prior history of psychostimulant treatment. Participants with aggressive symptoms persisting after an open-label optimization of psychostimulant medication entered the 8-week randomized phase. Weekly sessions of family-based behavioral treatment were offered during both the optimization and the randomized phases. Among the 151 participants who completed the optimization phase (175 were initially enrolled), an unexpected 63.6% met the study criteria for remission, that is, 3 consecutive weeks with subthreshold scores on the Retrospective-Modified Overt Aggression Scale (R-MOAS). Therefore, only 45 participants were eligible for randomization, and 40 (RISP: n = 17; DVPX: n = 14; placebo: n = 9) were included in the primary analysis. Why did JAACAP publish an inconclusive trial? Because, in our view, the lessons that can be learned from this RCT (in particular, from its optimization phase) are highly relevant for both clinicians and trialists in the field. We are confident that the Blader et al. study will contribute to make clinicians in the field more ""optimizers"" and trialists more ""transparent.""",2021,Participants with aggressive symptoms persisting after an open-label optimization of psychostimulant medication entered the 8-week randomized phase.,"['45 participants were eligible for randomization, and 40 (RISP: n\xa0= 17; DVPX: n\xa0= 14', 'Participants with aggressive symptoms persisting after an open-label optimization of psychostimulant medication entered the 8-week randomized phase', '151 participants who completed the optimization phase (175 were initially enrolled', 'children (aged 6-12 years) with attention-deficit/hyperactivity disorder (ADHD) and comorbid oppositional defiant disorder (ODD) or conduct disorder (CD']","['JAACAP', 'adjunctive risperidone (RISP), valproex sodium (DVPX), or placebo', 'placebo']",['Retrospective-Modified Overt Aggression Scale (R-MOAS'],"[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0304403', 'cui_str': 'Psychostimulant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0029121', 'cui_str': 'Oppositional defiant disorder'}, {'cui': 'C0149654', 'cui_str': 'Conduct disorder'}]","[{'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",9.0,0.119459,Participants with aggressive symptoms persisting after an open-label optimization of psychostimulant medication entered the 8-week randomized phase.,"[{'ForeName': 'Samuele', 'Initials': 'S', 'LastName': 'Cortese', 'Affiliation': 'Center for Innovation in Mental Health, Academic Unit of Psychology, Faculty of Environmental and Life Sciences; Clinical and Experimental Sciences (CNS and Psychiatry), Faculty of Medicine, University of Southampton, UK; Solent NHS Trust, Southampton, UK; New York University Child Study Center; Division of Psychiatry and Applied Psychology, School of Medicine, University of Nottingham, Nottingham, UK. Electronic address: samuele.cortese@soton.ac.uk.'}, {'ForeName': 'Douglas K', 'Initials': 'DK', 'LastName': 'Novins', 'Affiliation': 'Anschutz Medical Campus, University of Colorado, Aurora.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2020.03.009'] 1742,33341950,Lessons learned from the implementation of a video health coaching technology intervention to improve self-care of family caregivers of adults with heart failure.,"Individuals with heart failure (HF) typically live in the community and are cared for at home by family caregivers. These caregivers often lack supportive services and the time to access those services when available. Technology can play a role in conveniently bringing needed support to these caregivers. The purpose of this article is to describe the implementation of a virtual health coaching intervention with caregivers of HF patients (""Virtual Caregiver Coach for You""-ViCCY). A randomized controlled trial is currently in progress to test the efficacy of the intervention to improve self-care. In this trial, 250 caregivers will be randomly assigned to receive health information via a tablet computer (hereafter, tablet) plus 10 live health coaching sessions delivered virtually (intervention group; n = 125) or health information via a tablet only (control group; n = 125). Each tablet has specific health information websites preloaded. To inform others embarking on similar technology projects, here we highlight the technology challenges encountered with the first 15 caregivers who received the ViCCY intervention and the solutions used to overcome those challenges. Several adaptations to the implementation of ViCCY were needed to address hardware, software, and network connectivity challenges. Even with a well-designed research implementation plan, it is important to re-examine strategies at every step to solve implementation barriers and maximize fidelity to the intervention. Researcher and interventionist flexibility in adapting to new strategies is essential when implementing a technology-based virtual health coaching intervention.",2021,Researcher and interventionist flexibility in adapting to new strategies is essential when implementing a technology-based virtual health coaching intervention.,"['caregivers of HF patients (""Virtual Caregiver Coach for You""-ViCCY', 'family caregivers of adults with heart failure', '250 caregivers', '15 caregivers who received the', 'Individuals with heart failure (HF) typically live in the community and are cared for at home by family caregivers']","['video health coaching technology intervention', 'ViCCY intervention', 'health information via a tablet computer (hereafter, tablet) plus 10 live health coaching sessions delivered virtually (intervention group; n\u2009=\u2009125) or health information via a tablet only (control group; n\u2009=\u2009125', 'virtual health coaching intervention']",[],"[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4045980', 'cui_str': 'Tablet Computers'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],250.0,0.0302281,Researcher and interventionist flexibility in adapting to new strategies is essential when implementing a technology-based virtual health coaching intervention.,"[{'ForeName': 'Karen B', 'Initials': 'KB', 'LastName': 'Hirschman', 'Affiliation': 'NewCourtland Center for Transitions and Health, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Kathryn H', 'Initials': 'KH', 'LastName': 'Bowles', 'Affiliation': 'NewCourtland Center for Transitions and Health, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Garcia-Gonzalez', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Shepard', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Tracie J', 'Initials': 'TJ', 'LastName': 'Walser', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Gladys L', 'Initials': 'GL', 'LastName': 'Thomas', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Stawnychy', 'Affiliation': 'NewCourtland Center for Transitions and Health, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Riegel', 'Affiliation': 'NewCourtland Center for Transitions and Health, Philadelphia, Pennsylvania, USA.'}]",Research in nursing & health,['10.1002/nur.22100'] 1743,33337437,Pain and Spirituality Outcomes Among Women With Advanced Breast Cancer Participating in a Foot Reflexology Trial.,"OBJECTIVES To examine pain and spirituality, demographic and clinical factors associated with pain and spirituality, the contribution of spirituality to experiences of pain over time, and how pain and spirituality relate to engagement with a caregiver-delivered intervention. SAMPLE & SETTING Women with advanced breast cancer (N = 256) enrolled in a home-based randomized controlled trial of foot reflexology. METHODS & VARIABLES Secondary analyses were conducted with baseline and postintervention data. Stepwise model building, linear mixed-effects modeling, and negative binomial regression were used. RESULTS Participants who were younger, not married or partnered, not employed, or receiving hormonal therapy had increased odds of higher pain levels. Those who were older, non-White, or Christian had increased odds of higher spirituality. Spirituality's contribution to pain was not significant over time. IMPLICATIONS FOR NURSING Women in this sample experienced moderate pain, on average, at baseline. Women with specific demographic and clinical characteristics may require additional support with pain management and spiritual care.",2021,"Those who were older, non-White, or Christian had increased odds of higher spirituality.","['Women With Advanced Breast Cancer Participating in a Foot Reflexology Trial', 'Women with advanced breast cancer (N = 256) enrolled in a home-based randomized controlled trial of foot reflexology']",['SAMPLE &'],"['Pain and Spirituality Outcomes', 'moderate pain', 'pain levels']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0034945', 'cui_str': 'Reflexology'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001465', 'cui_str': 'Adenosine phosphate'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237104', 'cui_str': 'Spirituality'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0278139', 'cui_str': 'Moderate pain'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",256.0,0.122341,"Those who were older, non-White, or Christian had increased odds of higher spirituality.","[{'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': 'Michigan State University.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': 'Shanghai Pudong Development Bank.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lehto', 'Affiliation': 'Michigan State University.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Moser', 'Affiliation': 'Michigan State University.'}, {'ForeName': 'Horng-Shiuann', 'Initials': 'HS', 'LastName': 'Wu', 'Affiliation': 'Michigan State University.'}, {'ForeName': 'Gwen', 'Initials': 'G', 'LastName': 'Wyatt', 'Affiliation': 'Michigan State University.'}]",Oncology nursing forum,['10.1188/21.ONF.31-43'] 1744,33337436,Change in Health-Related Quality of Life Among Individuals With Cancer Undergoing Smoking Cessation Treatment Involving Varenicline.,"OBJECTIVES To determine whether health-related quality of life (HRQOL) among individuals with cancer is undermined by smoking cessation treatment involving varenicline. SAMPLE & SETTING Participants (N = 103) were daily smokers with cancer (up to five years postdiagnosis) who completed a placebo-controlled trial of standard versus extended duration varenicline. METHODS & VARIABLES For this secondary study, participants were selected based on having completed the SF-12® at weeks 0, 1, 12, and 24. Using separate repeated measures multivariate analysis of variance, change in SF-12 scores was evaluated by time and by cancer treatment, varenicline duration, and quit status at week 24. RESULTS There was no change in any of the three HRQOL scores by time or by cancer treatment status, varenicline duration, or quit status. Average emotional HRQOL score across time was significantly higher for quitters versus smokers. IMPLICATIONS FOR NURSING Varenicline, including long-term treatment, does not appear to adversely affect HRQOL, which is highly relevant to oncology nurses who are well positioned to assist with the pharmacologic treatment of tobacco dependence.",2021,"There was no change in any of the three HRQOL scores by time or by cancer treatment status, varenicline duration, or quit status.","['Individuals With Cancer Undergoing Smoking Cessation Treatment Involving', 'participants were selected based on having completed the SF-12® at weeks 0, 1, 12, and 24', 'individuals with cancer', 'Participants (N = 103) were daily smokers with cancer (up to five years postdiagnosis) who completed a']","['SAMPLE &', 'varenicline', 'placebo-controlled trial of standard versus extended duration varenicline', 'Varenicline']","['health-related quality of life (HRQOL', 'Average emotional HRQOL score across time', 'Change in Health-Related Quality of Life', 'SF-12 scores', 'HRQOL scores by time or by cancer treatment status, varenicline duration, or quit status']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C3266136', 'cui_str': 'Smokes tobacco daily'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001465', 'cui_str': 'Adenosine phosphate'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",103.0,0.0334275,"There was no change in any of the three HRQOL scores by time or by cancer treatment status, varenicline duration, or quit status.","[{'ForeName': 'Julia R', 'Initials': 'JR', 'LastName': 'May', 'Affiliation': 'Northwestern University.'}, {'ForeName': 'Nancy C', 'Initials': 'NC', 'LastName': 'Jao', 'Affiliation': 'Northwestern University.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'McCarter', 'Affiliation': 'University of Newcastle.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Klass', 'Affiliation': ''}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Pearman', 'Affiliation': 'Northwestern University.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Leone', 'Affiliation': 'University of Pennsylvania Presbyterian Medical Center.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Schnoll', 'Affiliation': 'University of Pennsylvania.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hitsman', 'Affiliation': 'Northwestern University.'}]",Oncology nursing forum,['10.1188/21.ONF.112-120'] 1745,33504126,Therapeutic Efficacy of Urethral Sphincter Injections of Platelet-Rich Plasma for the Treatment of Stress Urinary Incontinence due to Intrinsic Sphincter Deficiency: A Proof-of-Concept Clinical Trial.,"PURPOSE The aim of this study was to investigate the efficacy of autologous platelet-rich plasma (PRP) in the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) refractory to medical treatment. METHODS Thirty-five patients with SUI due to urodynamically proven ISD were prospectively enrolled. Five milliliters of PRP (2.5-5 times the platelet concentration in peripheral blood) was injected into the external sphincter at 5 sites; all patients received 4 injections at monthly intervals. The primary end-point was the change in SUI severity as assessed by a visual analogue scale (VAS of SUI). The secondary-endpoints were the Global Response Assessment score and changes in urodynamic parameters from baseline to 3 months after treatment. RESULTS The mean age of patients was 68.7±12 years; the median duration of SUI was 4 years. Five patients had neurogenic SUI, while 30 had nonneurogenic SUI (21 with postprostatectomy incontinence, 6 with previous radical cystectomy, and 3 with other etiologies). Complete dryness was achieved in 7 patients (20.0%) while moderate improvement was observed in 14 (40.0%). The mean VAS of SUI score decreased significantly from 6.57±1.89 to 3.77±2.41 after treatment. The abdominal leak point pressure (ALPP) increased significantly from 98.3±55.8 to 157.3±79.3 cm H2O. There was no increase of ALPP in neurogenic SUI and less increase of ALPP in patients with failed treatment outcomes. No perioperative adverse events or severe complications occurred. CONCLUSION Urethral PRP injection is safe and effective in increasing urethral resistance and improving SUI. PRP could be an alternative treatment modality for male and female patients with moderate SUI due to nonneurogenic causes.",2021,There was no increase of ALPP in neurogenic SUI and less increase of ALPP in patients with failed treatment outcomes.,"['male and female patients with moderate SUI due to nonneurogenic causes', 'Thirty-five patients with SUI due to urodynamically proven ISD were prospectively enrolled', 'stress urinary incontinence (SUI', 'Five patients had neurogenic SUI, while 30 had nonneurogenic SUI (21 with postprostatectomy incontinence, 6 with previous radical cystectomy, and 3 with other etiologies', 'Stress Urinary Incontinence due to Intrinsic Sphincter Deficiency']","['Urethral PRP injection', 'PRP', 'autologous platelet-rich plasma (PRP', 'Urethral Sphincter Injections of Platelet-Rich Plasma']","['ALPP', 'moderate improvement', 'ALPP in neurogenic SUI', 'abdominal leak point pressure (ALPP', 'change in SUI severity', 'urethral resistance and improving SUI', 'visual analogue scale (VAS of SUI', 'Global Response Assessment score and changes in urodynamic parameters', 'median duration of SUI', 'perioperative adverse events or severe complications', 'Complete dryness', 'mean VAS of SUI score']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0375381', 'cui_str': 'Urethral intrinsic sphincter deficiency'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}]","[{'cui': 'C0041967', 'cui_str': 'Urethral'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0457053', 'cui_str': 'Urethral sphincter'}, {'cui': 'C2957363', 'cui_str': 'Injection of platelet-rich plasma'}]","[{'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0232844', 'cui_str': 'Urethral resistance'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",35.0,0.030627,There was no increase of ALPP in neurogenic SUI and less increase of ALPP in patients with failed treatment outcomes.,"[{'ForeName': 'Yuang-Hong', 'Initials': 'YH', 'LastName': 'Jiang', 'Affiliation': 'Department of Urology, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Ping-Jui', 'Initials': 'PJ', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Hann-Chorng', 'Initials': 'HC', 'LastName': 'Kuo', 'Affiliation': 'Department of Urology, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Tzu Chi University, Hualien, Taiwan.'}]",International neurourology journal,['10.5213/inj.2040272.136'] 1746,33347632,Anti-calcitonin gene-related peptide monoclonal antibodies for neuropathic pain in patients with migraine headache.,"INTRODUCTION There is increasing evidence that calcitonin gene-related peptide (CGRP) plays a role in the development of neuropathic pain, a common feature of peripheral neuropathy. Although clinical studies have shown that anti-CGRP monoclonal antibodies are highly efficacious for migraine headache prophylaxis, their effects on nonheadache chronic pain conditions, including neuropathic pain, in humans are unknown. Therefore, the aim of this study was to assess the effectiveness of anti-CGRP monoclonal antibodies for neuropathic pain in patients with coexisting chronic migraine. METHODS A retrospective chart review was conducted of 14 patients with chronic migraine and peripheral neuropathy. All patients were treated with anti-CGRP monoclonal antibodies. We collected data on patient-reported scores on the Neuropathy Pain Scale (NPS) and the frequency of migraine headache days (MHDs) per month. Data were collected 3 and 0 months before and 3, 6, 9, and 12 months after treatment with anti-CGRP medications. RESULTS With treatment of anti-CGRP monoclonal antibodies, patients reported a 41.7% decrease in NPS scores from 89.3 at baseline to 52.1 at 12 months posttreatment (P < .05). In addition, there was a 33.3% decrease in MHDs per month from 19.8 at baseline to 13.2 at 12 months posttreatment (P < .05). DISCUSSION Administration of anti-CGRP medications significantly improved neuropathic pain in patients who also had chronic migraine. To confirm these promising outcomes, it would be worthwhile to conduct a blinded, randomized study with a larger population of patients.",2021,", patients observed a 41.7% decrease in NPS scores from 89.3 at baseline to 52.1 at 12 months post-treatment (p<0.05).","['patients with migraine headache', 'patients with coexisting chronic migraine', '14 patients with chronic migraine and peripheral neuropathy', 'patients who also had chronic migraine']","['Anti-CGRP monoclonal antibodies', 'anti-CGRP medications', 'anti-CGRP monoclonal antibodies']","['MHDs', 'neuropathy pain scale (NPS) and the frequency of migraine headache days (MHDs) per month', 'neuropathic pain', 'NPS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}]","[{'cui': 'C0006669', 'cui_str': 'Calcitonin gene-related peptide'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",14.0,0.06937,", patients observed a 41.7% decrease in NPS scores from 89.3 at baseline to 52.1 at 12 months post-treatment (p<0.05).","[{'ForeName': 'Seung Ah', 'Initials': 'SA', 'LastName': 'Kang', 'Affiliation': 'Department of Neurology, University of Missouri School of Medicine, Columbia, Missouri.'}, {'ForeName': 'Raghav', 'Initials': 'R', 'LastName': 'Govindarajan', 'Affiliation': 'Department of Neurology, University of Missouri School of Medicine, Columbia, Missouri.'}]",Muscle & nerve,['10.1002/mus.27153'] 1747,33349862,"A phase I/II randomized, placebo-controlled trial of romidepsin in persons with HIV-1 on suppressive antiretroviral therapy to assess safety and activation of HIV-1 expression (A5315).","BACKGROUND Romidepsin (RMD) is a histone deacetylase inhibitor reported to reverse HIV-1 latency. We sought to identify doses of RMD that were safe and induced HIV-1 expression. METHODS Enrollees had HIV-1 RNA <40 copies/ml on ART. Measurements included RMD levels, plasma viremia by single copy HIV-1 RNA assay, HIV-1 DNA, cell-associated unspliced HIV-1 RNA (CA-RNA), acetylation of histone H3-lysine-9 (H3K9ac+) and phosphorylation of transcription factor P-TEFb. Wilcoxon tests were used for comparison. RESULTS 43 participants enrolled in the single dose Cohorts 1-3 of 0.5, 2, and 5 mg/m 2 (36 RMD; 7 placebo) and 16 enrolled in the multi-dose Cohort 4 of 5 mg/m 2 (13 RMD; 3 placebo). One grade 3 event (neutropenia) was possibly treatment-related. No significant changes in viremia were observed in Cohorts 1-4 compared to placebo. In Cohort 4, observed pharmacodynamic effects of RMD were reduced proportions of CD4+ T cells 24 hours after infusions 2, 3, and 4 (median -3.5% to -4.5%) vs. placebo (+0.5% to 1%; p≤0.022) and increases in H3K9ac+ and phosphorylated P-TEFb in CD4 + T cells compared to placebo (p≤0.02). CONCLUSIONS RMD infusions were safe but did not increase plasma viremia or unspliced CA-RNA despite pharmacodynamic effects on CD4 + T cells. The trial is registered with ClinicalTrials.gov, number NCT01933594.",2020,"CONCLUSIONS RMD infusions were safe but did not increase plasma viremia or unspliced CA-RNA despite pharmacodynamic effects on CD4 + T cells.","['43 participants enrolled in the single dose Cohorts 1-3 of 0.5, 2, and 5\xa0mg/m 2 (36 RMD; 7', 'persons with HIV-1 on suppressive antiretroviral therapy to assess', 'Enrollees had HIV-1 RNA <40 copies/ml on ART']","['placebo', 'romidepsin']","['CD4+ T cells', 'RMD levels, plasma viremia by single copy HIV-1 RNA assay, HIV-1 DNA, cell-associated unspliced HIV-1 RNA (CA-RNA), acetylation of histone H3-lysine-9 (H3K9ac+) and phosphorylation of transcription factor P-TEFb', 'safety and activation of HIV-1 expression', 'H3K9ac+ and phosphorylated P-TEFb in CD4 + T cells', 'viremia', 'plasma viremia']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C1527027', 'cui_str': 'romidepsin'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0205367', 'cui_str': 'Suppressive'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1527027', 'cui_str': 'romidepsin'}]","[{'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C1527027', 'cui_str': 'romidepsin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1294179', 'cui_str': 'HIV 1 RNA assay'}, {'cui': 'C0486948', 'cui_str': 'Human immunodeficiency virus 1 DNA'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0001038', 'cui_str': 'Acetylation'}, {'cui': 'C0019647', 'cui_str': 'Histone H3'}, {'cui': 'C0024337', 'cui_str': 'Lysine'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C0040649', 'cui_str': 'Genetic transcription'}, {'cui': 'C0033452', 'cui_str': 'Properdin'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0663446', 'cui_str': 'tat-Associated Kinase'}]",43.0,0.450544,"CONCLUSIONS RMD infusions were safe but did not increase plasma viremia or unspliced CA-RNA despite pharmacodynamic effects on CD4 + T cells.","[{'ForeName': 'Deborah K', 'Initials': 'DK', 'LastName': 'McMahon', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': 'Harvard TH Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Joshua C', 'Initials': 'JC', 'LastName': 'Cyktor', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Evgenia', 'Initials': 'E', 'LastName': 'Aga', 'Affiliation': 'Harvard TH Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Bernard J', 'Initials': 'BJ', 'LastName': 'Macatangay', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Godfrey', 'Affiliation': 'National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Para', 'Affiliation': 'The Ohio State University, Columbus, OH.'}, {'ForeName': 'Ronald T', 'Initials': 'RT', 'LastName': 'Mitsuyasu', 'Affiliation': 'University of California Los Angeles, Los Angeles, CA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Hesselgesser', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Dragavon', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Dobrowolski', 'Affiliation': 'Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Karn', 'Affiliation': 'Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'Edward P', 'Initials': 'EP', 'LastName': 'Acosta', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Rajesh T', 'Initials': 'RT', 'LastName': 'Gandhi', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, Boston, MA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Mellors', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of infectious diseases,['10.1093/infdis/jiaa777'] 1748,33353385,Occupational Performance Coaching for Mothers of Children with Disabilities in India.,"BACKGROUND. Occupational Performance Coaching (OPC) aims to help mothers plan and manage theirs and their children's occupational performance. PURPOSE. To assess the effectiveness of OPC in improving occupational performance and parenting competence of mothers of children with disabilities in an Indian context. METHOD. Mixed method design was used. Thirty-six mothers were assigned to intervention or control groups. Occupational performance and parenting competence were measured at three time points. Semi-structured interviews were used. FINDINGS. OPC had significant effects on children's occupational performance ( p < 0.001), mothers' occupational performance ( p < 0.001), and self-competence ( p = 0.003). There was also a significant difference between control and intervention groups in occupational performance ( p = 0.001) and satisfaction ( p = 0.003). Interviews revealed three themes: acceptance, self-learning, and challenges during OPC. IMPLICATIONS. OPC is effective in improving the occupational performance and parenting competence of mothers of children with disabilities in varied cultural contexts.",2021,"OPC had significant effects on children's occupational performance ( p < 0.001), mothers' occupational performance ( p < 0.001), and self-competence ( p = 0.003).","['Thirty-six mothers', 'mothers of children with disabilities in an Indian context', 'Mothers of Children with Disabilities in India']","['OPC', 'Occupational Performance Coaching', 'Occupational Performance Coaching (OPC']","['Occupational performance and parenting competence', 'occupational performance', 'self-competence', 'satisfaction', 'acceptance, self-learning, and challenges during OPC', ""children's occupational performance"", ""mothers' occupational performance"", 'occupational performance and parenting competence']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0521127', 'cui_str': 'Occupational'}]","[{'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]",36.0,0.0459339,"OPC had significant effects on children's occupational performance ( p < 0.001), mothers' occupational performance ( p < 0.001), and self-competence ( p = 0.003).","[{'ForeName': 'C Suja', 'Initials': 'CS', 'LastName': 'Angelin', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sugi', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Rajendran', 'Affiliation': ''}]",Canadian journal of occupational therapy. Revue canadienne d'ergotherapie,['10.1177/0008417420972868'] 1749,33349594,"Food-Based Science, Technology, Engineering, Arts, and Mathematics (STEAM) Learning Activities May Reduce Decline in Preschoolers' Skin Carotenoid Status.","OBJECTIVE To assess the effectiveness of food-based science, technology, engineering, arts, and mathematics (STEAM) learning activities on preschoolers' liking of 9 target vegetables and objectively-assessed fruit and vegetable (FV) intake. METHODS Seven hands-on, food-based STEAM learning activities were implemented to expose children to 9 target vegetables in 3 Head Start preschools (11 classrooms) across North Carolina. Child-reported vegetable liking scores and skin carotenoid status (SCS) were dependent variables collected at baseline, midpoint, and posttest. Adjusted repeated-measures ANOVA was used to examine intervention impact. RESULTS A total of 113 children (intervention = 49; comparison = 64) participated. Children were an average age of 3.7 ± 0.57 years at baseline. Mean target vegetable liking scores for the intervention and comparison groups, respectively, were 3.2 ± 0.19 and 3.2 ± 0.17 at baseline, 2.9 ± 0.17 and 3.1 ± 0.15 at midpoint, and 2.8 ± 0.15 and 3.1 ± 0.13 at posttest. A time × group interaction was not significant for target vegetable liking scores. Mean SCS were 268.6 ± 13.24 and 270.9 ± 12.13 at baseline, 271.3 ± 12.50 and 275.6 ± 11.46 at midpoint, and 267.8 ± 11.26 and 229.6 ± 10.32 at posttest for the intervention and comparison groups, respectively. A time × group interaction was significant for SCS (F 1,77  = 3.98; P = 0.02; r = 0.10). Both groups declined from baseline to posttest (intervention = 0.06%; comparison = 15.09%), which occurred after winter break, with a smaller decline observed in the intervention group (P = 0.02). CONCLUSIONS AND IMPLICATIONS Food-based STEAM learning activities may present a unique opportunity to affect FV intake while meeting academic standards. More research is needed to understand how liking for familiar FV changes over time and its relationship with consumption. In addition, more implementation research featuring larger sample sizes, teachers as the interventionist, and a longer study duration is needed to confirm the outcomes of food-based STEAM learning observed in the current study and the long-term impact this approach may have on children's' dietary quality.",2021,"Both groups declined from baseline to posttest (intervention = 0.06%; comparison = 15.09%), which occurred after winter break, with a smaller decline observed in the intervention group (P = 0.02). ","['113 children (intervention\u202f=\u202f49; comparison\u202f=\u202f64) participated', 'Seven hands-on, food-based STEAM learning activities were implemented to expose children to 9 target vegetables in 3 Head Start preschools (11 classrooms) across North Carolina', 'Children were an average age of 3.7 ± 0.57 years at baseline']",[],"[""preschoolers' liking of 9 target vegetables and objectively-assessed fruit and vegetable (FV) intake"", 'vegetable liking scores and skin carotenoid status (SCS', 'Mean target vegetable liking scores', 'Learning Activities', 'target vegetable liking scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0014279', 'cui_str': 'Engineering'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",[],"[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0007271', 'cui_str': 'Carotinoid'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",113.0,0.0330201,"Both groups declined from baseline to posttest (intervention = 0.06%; comparison = 15.09%), which occurred after winter break, with a smaller decline observed in the intervention group (P = 0.02). ","[{'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Bayles', 'Affiliation': 'Food-based Early Education (FEEd) Lab, Department of Nutrition Science, College of Allied Health Sciences, East Carolina University, Greenville, NC.'}, {'ForeName': 'Amanda D', 'Initials': 'AD', 'LastName': 'Peterson', 'Affiliation': 'Food-based Early Education (FEEd) Lab, Department of Nutrition Science, College of Allied Health Sciences, East Carolina University, Greenville, NC.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Jilcott Pitts', 'Affiliation': 'Department of Public Health, Brody School of Medicine, East Carolina University, Greenville, NC.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Bian', 'Affiliation': 'Office for Faculty Excellence, East Carolina University, Greenville, NC.'}, {'ForeName': 'L Suzanne', 'Initials': 'LS', 'LastName': 'Goodell', 'Affiliation': 'Department of Food, Bioprocessing, and Nutrition Sciences, North Carolina State University, Raleigh, NC.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Burkholder', 'Affiliation': 'Food-based Early Education (FEEd) Lab, Department of Nutrition Science, College of Allied Health Sciences, East Carolina University, Greenville, NC.'}, {'ForeName': 'Archana V', 'Initials': 'AV', 'LastName': 'Hegde', 'Affiliation': 'Department of Human Development and Family Science, College of Health and Human Performance, East Carolina University, Greenville, NC.'}, {'ForeName': 'Virginia C', 'Initials': 'VC', 'LastName': 'Stage', 'Affiliation': 'Food-based Early Education (FEEd) Lab, Department of Nutrition Science, College of Allied Health Sciences, East Carolina University, Greenville, NC. Electronic address: carrawaystagev@ecu.edu.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2020.10.017'] 1750,33355713,Effect of normobaric hypoxic exercise on blood pressure in old individuals.,"PURPOSE To test the hypothesis that the combination of endurance training and hypoxia leads to greater improvements in resting and exercise blood pressure in old sedentary individuals compared to endurance training only. METHODS We randomly assigned 29 old overweight participants (age: 62 ± 6 years, body mass index (BMI): 28.5 ± 0.5 kg/m 2 , 52% men) to single blind 8-week bicycle exercise in hypoxia (fraction of inspired oxygen (F I O 2 ) = 0.15) or normoxia (F I O 2  = 0.21). Brachial blood pressure was measured at rest, during maximal incremental exercise testing, and during a 30 min constant work rate test, at baseline and after the training period. RESULTS Work rate, heart rate and perceived exertion during training were similar in both groups, with lower oxygen saturation for participants exercising under hypoxia (88.7 ± 1.5 vs. 96.2 ± 1.2%, t(27) = - 13.04, p < 0.001, |g|= 4.85). Office blood pressure and blood pressure during incremental exercise tests did not change significantly in either group after the training program. Systolic blood pressure during the constant work rate test was reduced after training in hypoxia (160 ± 18 vs. 151 ± 14 mmHg, t(13) = 2.44 p < 0.05, |d|= 0.55) but not normoxia (154 ± 22 vs. 150 ± 16 mmHg, t(14) = 0.75, p = 0.46, |d|= 0.18) with no difference between groups over time (F = 0.08, p = 0.77, η 2  = 0.01). CONCLUSION In old individuals hypoxia in addition to exercise does not have superior effects on office or exercise blood pressure compared to training in normoxia. TRIAL REGISTRATION NUMBER ClinicalTrials.gov No. NCT02196623 (registered 22 July 2014).",2021,"In old individuals hypoxia in addition to exercise does not have superior effects on office or exercise blood pressure compared to training in normoxia. ","['29 old overweight participants (age: 62\u2009±\u20096 years, body mass index (BMI): 28.5\u2009±\u20090.5\xa0kg/m 2 , 52% men) to', 'old sedentary individuals', 'old individuals']","['normobaric hypoxic exercise', 'endurance training', 'single blind 8-week bicycle exercise in hypoxia (fraction of inspired oxygen (F I O 2 )\u2009=\u20090.15) or normoxia', 'endurance training and hypoxia']","['Brachial blood pressure', 'Work rate, heart rate and perceived exertion', 'Systolic blood pressure', 'blood pressure', 'Office blood pressure and blood pressure', 'resting and exercise blood pressure']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0242570', 'cui_str': 'Single-Masked Study'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005375', 'cui_str': 'Bicycle'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C4068886', 'cui_str': '0.15'}]","[{'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",29.0,0.111754,"In old individuals hypoxia in addition to exercise does not have superior effects on office or exercise blood pressure compared to training in normoxia. ","[{'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Hein', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Chobanyan-Jürgens', 'Affiliation': 'Institute of Clinical Pharmacology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Tegtbur', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Engeli', 'Affiliation': 'Institute of Clinical Pharmacology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Jordan', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center and University of Cologne, Cologne, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Haufe', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany. Haufe.sven@mh-hannover.de.'}]",European journal of applied physiology,['10.1007/s00421-020-04572-6'] 1751,33354769,Reducing the rate of psychiatric re-admissions in bipolar disorder using smartphones-The RADMIS trial.,"OBJECTIVES The MONARCA I and II trials were negative but suggested that smartphone-based monitoring may increase quality of life and reduce perceived stress in bipolar disorder (BD). The present trial was the first to investigate the effect of smartphone-based monitoring on the rate and duration of readmissions in BD. METHODS This was a randomized controlled single-blind parallel-group trial. Patients with BD (ICD-10) discharged from hospitalization in the Mental Health Services, Capital Region of Denmark were randomized 1:1 to daily smartphone-based monitoring including a feedback loop (+ standard treatment) or to standard treatment for 6 months. Primary outcomes: the rate and duration of psychiatric readmissions. RESULTS We included 98 patients with BD. In ITT analyses, there was no statistically significant difference in rates (hazard rate: 1.05, 95% CI: 0.54; 1.91, p = 0.88) or duration of readmission between the two groups (B: 3.67, 95% CI: -4.77; 12.11, p = 0.39). There was no difference in scores on the Hamilton Depression Rating Scale (B = -0.11, 95% CI: -2.50; 2.29, p = 0.93). The intervention group had higher scores on the Young Mania Rating Scale (B: 1.89, 95% CI: 0.0078; 3.78, p = 0.050). The intervention group reported lower levels of perceived stress (B: -7.18, 95% CI: -13.50; -0.86, p = 0.026) and lower levels of rumination (B: -6.09, 95% CI: -11.19; -1.00, p = 0.019). CONCLUSIONS Smartphone-based monitoring did not reduce rate and duration of readmissions. There was no difference in levels of depressive symptoms. The intervention group had higher levels of manic symptoms, but lower perceived stress and rumination compared with the control group.",2021,"The intervention group had higher levels of manic symptoms, but lower perceived stress and rumination compared with the control group.","['Patients with BD (ICD-10) discharged from hospitalization in the Mental Health Services, Capital Region of Denmark', '98 patients with BD']","['daily smartphone-based monitoring including a feedback loop (+ standard treatment', 'smartphone-based monitoring']","['duration of readmission', 'Hamilton Depression Rating Scale', 'higher levels of manic symptoms', 'lower levels of perceived stress', 'lower levels of rumination', 'rate of psychiatric Re-ADMISsions', 'stress and rumination', 'Young Mania Rating Scale', 'rate and duration of psychiatric readmissions', 'levels of depressive symptoms', 'quality of life', 'rate and duration of readmissions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C4087288', 'cui_str': 'Young mania rating scale'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",98.0,0.172974,"The intervention group had higher levels of manic symptoms, but lower perceived stress and rumination compared with the control group.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Faurholt-Jepsen', 'Affiliation': 'Copenhagen Affective Disorder Research Center (CADIC), Psychiatric Center Copenhagen, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Lindbjerg Tønning', 'Affiliation': 'Copenhagen Affective Disorder Research Center (CADIC), Psychiatric Center Copenhagen, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Fros', 'Affiliation': 'Monsenso Aps, Copenhagen, Denmark.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Martiny', 'Affiliation': 'Copenhagen Affective Disorder Research Center (CADIC), Psychiatric Center Copenhagen, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Nanna', 'Initials': 'N', 'LastName': 'Tuxen', 'Affiliation': 'Copenhagen Affective Disorder Research Center (CADIC), Psychiatric Center Copenhagen, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Rosenberg', 'Affiliation': 'Copenhagen Affective Disorder Research Center (CADIC), Psychiatric Center Copenhagen, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Busk', 'Affiliation': 'Department of Applied Mathematics and Computer Science, Technical University of Denmark, Lyngby, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Winther', 'Affiliation': 'Department of Applied Mathematics and Computer Science, Technical University of Denmark, Lyngby, Denmark.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Thaysen-Petersen', 'Affiliation': 'Psychiatric Center Ballerup, Ballerup, Denmark.'}, {'ForeName': 'Kate Andreasson', 'Initials': 'KA', 'LastName': 'Aamund', 'Affiliation': 'Psychiatric Center North Zealand, Hilleroed, Denmark.'}, {'ForeName': 'Lizzie', 'Initials': 'L', 'LastName': 'Tolderlund', 'Affiliation': 'Psychiatric Center North Zealand, Hilleroed, Denmark.'}, {'ForeName': 'Jakob Eyvind', 'Initials': 'JE', 'LastName': 'Bardram', 'Affiliation': 'Monsenso Aps, Copenhagen, Denmark.'}, {'ForeName': 'Lars Vedel', 'Initials': 'LV', 'LastName': 'Kessing', 'Affiliation': 'Copenhagen Affective Disorder Research Center (CADIC), Psychiatric Center Copenhagen, Rigshospitalet, Copenhagen, Denmark.'}]",Acta psychiatrica Scandinavica,['10.1111/acps.13274'] 1752,33361317,Plasma and Urine Metabolite Profiles Impacted by Increased Dietary Navy Bean Intake in Colorectal Cancer Survivors: A Randomized-Controlled Trial.,"Navy beans contain bioactive phytochemicals with colon cancer prevention properties as demonstrated in carcinogen-induced animal models. Human studies support that dietary navy bean intake modulates metabolism by the gut microbiome. This study investigated the effect of navy bean ingestion on plasma and urine metabolite profiles of overweight and obese colorectal cancer survivors. Twenty participants completed a single-blinded, randomized-controlled dietary intervention with precooked navy beans (35 g bean powder/day) or control (0 g/day) for 4 weeks. Plasma and urine were collected at baseline, 2 weeks, and 4 weeks following consumption. Nontargeted metabolomics was applied to study meals and snacks, navy beans, plasma, and urine. Increased navy bean consumption was hypothesized to (i) delineate dietary biomarkers and (ii) promote metabolic shifts relevant for cancer protection in the plasma and urine metabolome. At 4 weeks, 16 plasma and 16 urine metabolites were significantly different in the navy bean intervention group compared with placebo control ( P < 0.05). Increased plasma 2,3-dihydroxy-2-methylbutyrate (1.34-fold), S-methylcysteine (1.92-fold), and pipecolate (3.89-fold), and urine S-adenosylhomocysteine (2.09-fold) and cysteine (1.60-fold) represent metabolites with cancer-protective actions following navy bean consumption. Diet-derived metabolites were detected in plasma or urine and confirmed for presence in the navy bean intervention meals and snacks. These included 3-(4-hydroxyphenyl)propionate, betaine, pipecolate, S-methylcysteine, choline, eicosapentaenoate (20:5n3), benzoate, S-adenosylhomocysteine, N-delta-acetylornithine, cysteine, 3-(4-hydroxyphenyl)lactate, gentisate, hippurate, 4-hydroxyhippurate, and salicylate. The navy bean dietary intervention for 4 weeks showed changes to pathways of metabolic importance to colorectal cancer prevention and merit continued attention for dietary modulation in future high-risk cohort investigations. PREVENTION RELEVANCE: This clinical study suggests that increased consumption of navy beans would deliver bioactive metabolites to individuals at high risk for colorectal cancer recurrence and produce metabolic shifts in plasma and urine profiles.",2021,"At 4 weeks, 16 plasma and 16 urine metabolites were significantly different in the navy bean intervention group compared to placebo-control (p< 0.05).","['Colorectal Cancer Survivors', 'Twenty participants completed a single-blinded', 'overweight and obese colorectal cancer (CRC) survivors']","['eicosapentaenoate (20:5n3), benzoate, S-adenosylhomocysteine, N-delta-acetylornithine, cysteine, 3-(4-hydroxyphenyl)lactate, gentisate, hippurate, 4-hydroxyhippurate, and salicylate', 'randomized-controlled dietary intervention with pre-cooked navy beans', 'navy bean ingestion', 'dietary navy bean intake', 'Plasma and Urine Metabolite Profiles Impacted by Increased Dietary Navy Bean Intake', 'Navy beans']","['Plasma and urine', 'plasma 2,3-dihydroxy-2-methylbutyrate']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0242570', 'cui_str': 'Single-Masked Study'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C1370123', 'cui_str': 'Eicosapentaenoate'}, {'cui': 'C0005058', 'cui_str': 'Benzoates'}, {'cui': 'C0036001', 'cui_str': 'S-Adenosyl homocysteine'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0010654', 'cui_str': 'Cysteine'}, {'cui': 'C0017442', 'cui_str': '2,5-Dihydroxybenzoic Acids'}, {'cui': 'C0019568', 'cui_str': 'Hippurates'}, {'cui': 'C0036075', 'cui_str': 'Salicylate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0004896', 'cui_str': 'Bean'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0046367', 'cui_str': '2-methylbutyrate'}]",,0.0660435,"At 4 weeks, 16 plasma and 16 urine metabolites were significantly different in the navy bean intervention group compared to placebo-control (p< 0.05).","[{'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'Zarei', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, College of Veterinary Medicine and Biomedical Sciences, Colorado State University, Fort Collins, Colorado.'}, {'ForeName': 'Bridget A', 'Initials': 'BA', 'LastName': 'Baxter', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, College of Veterinary Medicine and Biomedical Sciences, Colorado State University, Fort Collins, Colorado.'}, {'ForeName': 'Renee C', 'Initials': 'RC', 'LastName': 'Oppel', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, College of Veterinary Medicine and Biomedical Sciences, Colorado State University, Fort Collins, Colorado.'}, {'ForeName': 'Erica C', 'Initials': 'EC', 'LastName': 'Borresen', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, College of Veterinary Medicine and Biomedical Sciences, Colorado State University, Fort Collins, Colorado.'}, {'ForeName': 'Regina J', 'Initials': 'RJ', 'LastName': 'Brown', 'Affiliation': 'University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'Elizabeth P', 'Initials': 'EP', 'LastName': 'Ryan', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, College of Veterinary Medicine and Biomedical Sciences, Colorado State University, Fort Collins, Colorado. E.P.Ryan@colostate.edu.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-20-0270'] 1753,33367944,Clinical Outcomes of Ambulatory Endovascular Treatment Using 4-French and 6-French Femoral Access Strategies: The Bio4amb Multicentre Trial.,"PURPOSE Ambulatory peripheral vascular interventions have been steadily increasing. In ambulatory procedures, 4F devices might be particularly useful having the potential to reduce access-site complications; however, further evidence on their safety and efficacy is needed. MATERIALS AND METHODS BIO4AMB is a prospective, non-randomized mulitcentre, non-inferiority trial conducted in 35 centres in Europe and Australia comparing the use of 4F- and 6F-compatible devices. The main exclusion criteria included an American Society of Anaesthesiologists class ≥ 4, coagulation disorders, or social isolation. The primary endpoint was access-site complications within 30 days. RESULTS The 4F group enrolled 390 patients and the 6F group 404 patients. Baseline characteristics were similar between the groups. Vascular closure devices were used in 7.7% (4F group) and 87.6% (6F group) of patients. Patients with vascular closure device use in the 4F group were subsequently excluded from the primary analysis, resulting in 361 patients in the 4F group. Time to haemostasis was longer for the 4F group, but the total procedure time was shorter (13.2 ± 18.8 vs. 6.4 ± 8.9 min, p < 0.0001, and 39.1 ± 25.2 vs. 46.4 ± 27.6 min, p < 0.0001). Discharge on the day of the procedure was possible in 95.0% (4F group) and 94.6% (6F group) of patients. Access-site complications were similar between the groups (2.8% and 3.2%) and included predominantly groin haematomas and pseudoaneurysms. Major adverse events through 30 days occurred in 1.7% and 2.0%, respectively. CONCLUSIONS Ambulatory peripheral vascular interventions are feasible and safe. The use of 4F devices resulted in similar outcomes compared to that of 6F devices.",2020,"Time to haemostasis was longer for the 4F group, but the total procedure time was shorter (13.2 ± 18.8 vs. 6.4 ± 8.9 min, p < 0.0001, and 39.1 ± 25.2 vs. 46.4 ± 27.6 min, p < 0.0001).","['35 centres in Europe and Australia comparing the use of', 'The main exclusion criteria included an American Society of Anaesthesiologists class\u2009≥\u20094, coagulation disorders, or social isolation', 'The 4F group enrolled 390 patients and the 6F group 404 patients', 'Patients with vascular closure device use in the 4F group were subsequently excluded from the primary analysis, resulting in 361 patients in the 4F group']","['4F- and 6F-compatible devices', 'Ambulatory Endovascular Treatment Using 4-French and 6-French Femoral Access Strategies']","['Time to haemostasis', 'total procedure time', 'Major adverse events', 'Access-site complications', 'Vascular closure devices', 'access-site complications']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3504161', 'cui_str': 'Vascular Closure Devices'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}]","[{'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0444454', 'cui_str': 'Access'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0589360', 'cui_str': 'Site of access'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3504161', 'cui_str': 'Vascular Closure Devices'}]",390.0,0.174628,"Time to haemostasis was longer for the 4F group, but the total procedure time was shorter (13.2 ± 18.8 vs. 6.4 ± 8.9 min, p < 0.0001, and 39.1 ± 25.2 vs. 46.4 ± 27.6 min, p < 0.0001).","[{'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Brodmann', 'Affiliation': 'Department of Angiology, Medical University Graz, Auenbruggerplatz 15, 8036, Graz, Austria. marianne.brodmann@medunigraz.at.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Deloose', 'Affiliation': 'Department of Vascular Surgery, Sint Blasius Hospital, Dendermonde, AZ, Belgium.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Steinmetz', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, CHU François Mitterrand, Dijon, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Regnard', 'Affiliation': 'Department of Vascular Surgery, Clinique Saint Joseph, Trelaze, France.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Ritter', 'Affiliation': 'Department of Vascular Surgery, Fiona Stanley Hospital, Perth, Australia.'}, {'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Berger', 'Affiliation': 'Vascular Surgery Department, CHU de Caen, France.'}, {'ForeName': 'Johannes B', 'Initials': 'JB', 'LastName': 'Dahm', 'Affiliation': 'Department of Angiology and Cardiology, Herz- und Gefässzentrum Neu-Bethlehem, Göttingen, Germany.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Jansen', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Sir Charles Gairdner Hospital, Perth, WA, Australia.'}, {'ForeName': 'Bibombe P', 'Initials': 'BP', 'LastName': 'Mwipatayi', 'Affiliation': 'Perth Institute of Vascular Research, Hollywood Specialist Centre, Nedlands, Australia.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Desgranges', 'Affiliation': 'AP-HP, Hopital Henri Mondor, Creteil, France.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Hausegger', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, LKH, Klagenfurt, Austria.'}, {'ForeName': 'Jos C', 'Initials': 'JC', 'LastName': 'van den Berg', 'Affiliation': 'Centro Vascolare Ticin, Ospedale Regionale di Lugano, Lugano, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cardiovascular and interventional radiology,['10.1007/s00270-020-02738-5'] 1754,33387108,Various modalities for management of secondary angle closure neovascular glaucoma in diabetic eyes: 1-year comparative study.,"PURPOSE To compare outcome of 4 methods for management of angle closure neovascular glaucoma (NVG) in diabetic eyes. METHODS Prospective comparative study, on 40 eyes (40 patients) with NVG. Patients were randomly assigned to group A (Trabeculectomy with MMC), B (Ahmed valve), C (Ex-Press Minishunt with MMC) or D (Diode cyclophotocoagulation). Patients were followed regularly for 1 year. MAIN OUTCOME MEASURES intraocular pressure (IOP), best corrected visual acuity (BCVA), central foveal thickness (CFT), intraoperative bleeding, postoperative complications and 2ry intervention. RESULTS Preoperative data were not significantly different between 4 groups. Postoperatively, there was significant drop in IOP in each group at each follow-up. Ahmed valve group showed least mean postoperative IOP and highest mean drop of the IOP at 1 day and 1 week postoperatively, while Ex-Press minishunt group had least mean postoperative IOP at 1 month and 3 months postoperatively. At 6 months and 1 year, there was no significant difference between 4 groups. BCVA was not significantly different between 4 groups. At 1 year, CFT was significantly lower in each of the 4 groups, and it was significantly the least in group A and highest in group D. Highest intraoperative bleeding was observed with trabeculectomy. Success rate was not significantly different among the 4 groups. CONCLUSION The 4 management options showed a significant long-term effect on IOP, and on long-terms there was no significant difference between them for IOP and BCVA. Trabeculectomy showed highest incidence of intraoperative bleeding, while cyclophotocoagulation showed none.",2021,"Ahmed valve group showed least mean postoperative IOP and highest mean drop of the IOP at 1 day and 1 week postoperatively, while Ex-Press minishunt group had least mean postoperative IOP at 1 month and 3 months postoperatively.","['secondary angle closure neovascular glaucoma in diabetic eyes', 'diabetic eyes', '40 eyes (40 patients) with NVG']","['group A (Trabeculectomy with MMC), B (Ahmed valve), C (Ex-Press Minishunt with MMC) or D (Diode cyclophotocoagulation', 'angle closure neovascular glaucoma (NVG', 'Trabeculectomy']","['intraoperative bleeding', 'IOP and BCVA', 'BCVA', 'IOP', 'Success rate', 'CFT', 'intraocular pressure (IOP), best corrected visual acuity (BCVA), central foveal thickness (CFT), intraoperative bleeding, postoperative complications and 2ry intervention', 'least mean postoperative IOP']","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0429528', 'cui_str': 'Angle closure'}, {'cui': 'C0017609', 'cui_str': 'Neovascular glaucoma'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C1444577', 'cui_str': 'Ahmed tube shunt'}, {'cui': 'C0395490', 'cui_str': 'Photocoagulation of ciliary body'}, {'cui': 'C0429528', 'cui_str': 'Angle closure'}, {'cui': 'C0017609', 'cui_str': 'Neovascular glaucoma'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",40.0,0.0710455,"Ahmed valve group showed least mean postoperative IOP and highest mean drop of the IOP at 1 day and 1 week postoperatively, while Ex-Press minishunt group had least mean postoperative IOP at 1 month and 3 months postoperatively.","[{'ForeName': 'Heba Magdy Ahmed', 'Initials': 'HMA', 'LastName': 'El-Saied', 'Affiliation': 'Cairo University, Agouza, Egypt. hebamagdy13@yahoo.com.'}, {'ForeName': 'Mohamad Amr Salah Eddin', 'Initials': 'MASE', 'LastName': 'Abdelhakim', 'Affiliation': 'Cairo University, Agouza, Egypt.'}]",International ophthalmology,['10.1007/s10792-020-01673-1'] 1755,33386426,Femoroacetabular impingement surgery leads to early pain relief but minimal functional gains past 6 months: experience from the FIRST trial.,"PURPOSE To understand the early outcomes after hip arthroscopy and better define the trajectory of improvement in a prospective cohort of patients who have undergone hip arthroscopic osteochondroplasty for femoroacetabular impingement (FAI) syndrome. METHODS Data were analyzed from the Femoroacetabular Impingement RandomiSed controlled Trial (FIRST) on the 108 study patients who underwent osteochondroplasty, with or without labral repair. Study outcomes included patient-reported pain (using a 100-point Visual Analogue Scale (VAS)), hip function (using the Hip Outcome Score (HOS) and International Hip Outcome Tool (iHOT-12)), and health-related quality of life (using the EuroQol 5 Dimensions (EQ-5D)) measured at baseline, 2 weeks, 3 months, 6 months, and 12 months post-operatively. RESULTS There was a decrease in mean post-operative pain VAS scores from baseline. The first 2 weeks post-operative yielded the greatest reduction in pain with a mean (SD) VAS score of 37.8 (23.4), with score stabilization between 6 months (26.9 (26.9)) and 12 months (25.3 (27.6)). Mean HOS (activities of daily living) scores improved from baseline (59.7 (16.2)) starting at 6 weeks post-operative (64.1 (19.1)). The HOS (Sports) showed no improvement from baseline (41.2 (20.4)) until 3 months (49.1 (27.9)), and continued to improve at 6 months (64.1 (28.7)) and 12 months (68.6 (30.5)). The iHOT-12 scores showed functional improvement from baseline (31.3 (18.8)), as early as 6 weeks (44.9 (22.4)) up to and including 12 months (67.1 (29.7)). EQ-5D index scores showed modest steady improvement from 6 weeks to 12 months post-operative, while the EQ-5D VAS component similarly showed modest and steady improvements from 3 months onward. CONCLUSION Results from this study highlight that hip arthroscopic osteochondroplasty with or without labral repair for FAI leads to early pain relief. While all scores improved from baseline, functional gains appear to plateau from 6 months onwards. These data can be used to inform decision-making about timelines for rehabilitation and return to sport, a knowledge gap in the current FAI literature. LEVEL OF EVIDENCE II.",2021,Mean HOS (activities of daily living) scores improved from baseline (59.7 (16.2)) starting at 6 weeks post-operative (64.1 (19.1)).,"['Data were analyzed from the Femoroacetabular Impingement RandomiSed controlled Trial (FIRST) on the 108 study patients who underwent osteochondroplasty, with or without labral repair', 'patients who have undergone hip arthroscopic osteochondroplasty for femoroacetabular impingement (FAI) syndrome']",['Femoroacetabular impingement surgery'],"['EQ-5D index scores', 'patient-reported pain (using a 100-point Visual Analogue Scale (VAS)), hip function (using the Hip Outcome Score (HOS) and International Hip Outcome Tool (iHOT-12)), and health-related quality of life (using the EuroQol 5 Dimensions (EQ-5D', 'mean post-operative pain VAS scores', 'pain with a mean (SD) VAS score', 'Mean HOS (activities of daily living) scores']","[{'cui': 'C2936290', 'cui_str': 'Femoral acetabular impingement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C2936290', 'cui_str': 'Femoral acetabular impingement'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0265264', 'cui_str': 'Holt-Oram syndrome'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",108.0,0.0832745,Mean HOS (activities of daily living) scores improved from baseline (59.7 (16.2)) starting at 6 weeks post-operative (64.1 (19.1)).,"[{'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Almasri', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, 1200 Main St. W. 4E15, HamiltonHamilton, ON, L8N 3Z5, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Simunovic', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, 1200 Main St. W. 4E15, HamiltonHamilton, ON, L8N 3Z5, Canada.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Heels-Ansdell', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Olufemi R', 'Initials': 'OR', 'LastName': 'Ayeni', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, 1200 Main St. W. 4E15, HamiltonHamilton, ON, L8N 3Z5, Canada. ayenif@mcmaster.ca.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-020-06401-x'] 1756,33386288,Update from PSMA-SRT Trial NCT03582774: A Randomized Phase 3 Imaging Trial of Prostate-specific Membrane Antigen Positron Emission Tomography for Salvage Radiation Therapy for Prostate Cancer Recurrence Powered for Clinical Outcome.,"The purpose of this randomized trial is to evaluate the success rate of salvage radiation therapy for recurrence of prostate cancer after radical prostatectomy, with and without planning based on prostate-specific membrane antigen positron emission tomography/computed tomography. Enrollment has been completed and patients are being followed for 5yr.",2021,"The purpose of this randomized trial is to evaluate the success rate of salvage radiation therapy for recurrence of prostate cancer after radical prostatectomy, with and without planning based on prostate-specific membrane antigen positron emission tomography/computed tomography.",[],"['salvage radiation therapy', 'radical prostatectomy, with and without planning based on prostate-specific membrane antigen positron emission tomography/computed tomography', 'Prostate-specific Membrane Antigen Positron Emission Tomography']",[],[],"[{'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0067685', 'cui_str': 'Glutamate carboxypeptidase II'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]",[],,0.109863,"The purpose of this randomized trial is to evaluate the success rate of salvage radiation therapy for recurrence of prostate cancer after radical prostatectomy, with and without planning based on prostate-specific membrane antigen positron emission tomography/computed tomography.","[{'ForeName': 'Jeremie', 'Initials': 'J', 'LastName': 'Calais', 'Affiliation': 'Ahmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA; Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA, USA; Institute of Urologic Oncology, University of California, Los Angeles, Los Angeles, CA, USA; Physics and Biology in Medicine Interdepartmental Graduate Program, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA. Electronic address: jcalais@mednet.ucla.edu.'}, {'ForeName': 'Wesley R', 'Initials': 'WR', 'LastName': 'Armstrong', 'Affiliation': 'Ahmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Amar U', 'Initials': 'AU', 'LastName': 'Kishan', 'Affiliation': 'Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA, USA; Institute of Urologic Oncology, University of California, Los Angeles, Los Angeles, CA, USA; Department of Radiation Oncology, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Kiara M', 'Initials': 'KM', 'LastName': 'Booker', 'Affiliation': 'Ahmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Hope', 'Affiliation': 'Department of Radiology and Biomedical Imaging, University of California, San Francisco, San Francisco, CA, USA; Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA, USA; San Francisco VA Medical Center, San Francisco, CA, USA.'}, {'ForeName': 'Wolfgang P', 'Initials': 'WP', 'LastName': 'Fendler', 'Affiliation': 'Ahmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA; Department of Nuclear Medicine, University of Duisburg-Essen and German Cancer Consortium (DKTK)-University Hospital Essen, Essen, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Elashoff', 'Affiliation': 'Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA, USA; Department of Medicine Statistics Core, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Nicholas G', 'Initials': 'NG', 'LastName': 'Nickols', 'Affiliation': 'Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA, USA; Institute of Urologic Oncology, University of California, Los Angeles, Los Angeles, CA, USA; Department of Radiation Oncology, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA; Department of Radiation Oncology, VA Greater Los Angeles Healthcare System, Los Angeles, CA, USA.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Czernin', 'Affiliation': 'Ahmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA; Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA, USA; Institute of Urologic Oncology, University of California, Los Angeles, Los Angeles, CA, USA; Physics and Biology in Medicine Interdepartmental Graduate Program, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA.'}]",European urology focus,['10.1016/j.euf.2020.12.009'] 1757,33387217,Long-term intradialytic hybrid exercise training on fatigue symptoms in patients receiving hemodialysis therapy.,"PURPOSE Hemodialysis (HD) patients suffer from generalized weakness, exercise intolerance and muscle atrophy, all leading to generalized fatigue and lack of energy. HD patients spend at least 50% of their time in a functionally ""switch off"" mode with their fatigue sensations reaching a peak in the immediate hours after the dialysis session. The purpose of the current study was to assess the effectiveness of a nine-month hybrid intradialytic exercise program on fatigue symptoms occurring during and after hemodialysis session. METHODS Twenty stable hemodialysis patients were included in the study (59 ± 13.7 years; 16 males). All patients completed a 9-month supervised exercise training program composed of both aerobic cycling and resistance training during HD. Aspects related to physical and generalized fatigue were assessed via validated questionnaires, while physical performance was assessed by a battery of tests, before and after the intervention period. RESULTS Exercise capacity and physical performance were increased by an average of 65 and 40%, respectively. Patients reported feeling better during post-dialysis hours in question 1 (p = 0.000), question 3 (p = 0.009) and question 4 (p = 0.003) after the 9-month intervention. In addition, exercise training improved scores in cognitive function (p = 0.037), vitality (p = 0.05), depression (p = 0.000) and fatigue (p = 0.039). CONCLUSION The present study showed that a 9-month hybrid (aerobic + resistance) exercise training program improved symptoms of post-dialysis fatigue and overall general perception of fatigue. Hybrid exercise training is a safe and effective non-pharmacological approach to ameliorate fatigue symptoms in HD patients. TRIAL REGISTRATION NUMBER Trial registration number The study is registered at ClinicalTrials.gov (NCT01721551, 2012) as a clinical trial.",2021,"In addition, exercise training improved scores in cognitive function (p = 0.037), vitality (p = 0.05), depression (p = 0.000) and fatigue (p = 0.039). ","['fatigue symptoms occurring during and after hemodialysis session', 'Twenty stable hemodialysis patients were included in the study (59\u2009±\u200913.7 years; 16 males', 'HD patients', 'patients receiving hemodialysis therapy']","['supervised exercise training program composed of both aerobic cycling and resistance training during HD', 'intradialytic hybrid exercise training', 'exercise training', 'Hybrid exercise training', 'hybrid (aerobic\u2009+\u2009resistance) exercise training program', 'nine-month hybrid intradialytic exercise program']","['fatigue symptoms', 'depression', 'fatigue', 'vitality', 'symptoms of post-dialysis fatigue and overall general perception of fatigue', 'Exercise capacity and physical performance', 'scores in cognitive function']","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1264635', 'cui_str': 'Post-dialysis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",20.0,0.0230502,"In addition, exercise training improved scores in cognitive function (p = 0.037), vitality (p = 0.05), depression (p = 0.000) and fatigue (p = 0.039). ","[{'ForeName': 'Stefania S', 'Initials': 'SS', 'LastName': 'Grigoriou', 'Affiliation': 'Live Lab, Department of PE and Sport Science, University of Thessaly, 42100, Trikala, Greece.'}, {'ForeName': 'Argyro A', 'Initials': 'AA', 'LastName': 'Krase', 'Affiliation': 'Live Lab, Department of PE and Sport Science, University of Thessaly, 42100, Trikala, Greece.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Karatzaferi', 'Affiliation': 'Live Lab, Department of PE and Sport Science, University of Thessaly, 42100, Trikala, Greece.'}, {'ForeName': 'Christoforos D', 'Initials': 'CD', 'LastName': 'Giannaki', 'Affiliation': 'Department of Life and Health Sciences, University of Nicosia, Nicosia, Cyprus.'}, {'ForeName': 'Eleftherios', 'Initials': 'E', 'LastName': 'Lavdas', 'Affiliation': 'Department of Biomedical Sciences, University of West Attica, Athens, Greece.'}, {'ForeName': 'Georgia I', 'Initials': 'GI', 'LastName': 'Mitrou', 'Affiliation': 'Live Lab, Department of PE and Sport Science, University of Thessaly, 42100, Trikala, Greece.'}, {'ForeName': 'Saul', 'Initials': 'S', 'LastName': 'Bloxham', 'Affiliation': 'School of Sports, Health and Wellbeing, Plymouth Marjon Univeristy, Plymouth, UK.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Stefanidis', 'Affiliation': 'School of Health Science, Department of Medicine, University of Thessaly, Larissa, Greece.'}, {'ForeName': 'Giorgos K', 'Initials': 'GK', 'LastName': 'Sakkas', 'Affiliation': 'Live Lab, Department of PE and Sport Science, University of Thessaly, 42100, Trikala, Greece. gsakkas@uth.gr.'}]",International urology and nephrology,['10.1007/s11255-020-02711-8'] 1758,33387724,A randomized exploratory trial to assess the effects of resveratrol on VEGF and TNF-α 2 expression in endometriosis women.,"Resveratrol, a naturally synthesized polyphenolic compound found in some fruits, has anti neoplastic, anti-inflammatory, anti-oxidative, and anti-angiogenic properties. Angiogenesis is an important process in endometriosis which provides blood supply for implantation, proliferation and survival of endometriotic lesions. In this study, we assessed the effects of resveratrol on vascular endothelial growth factor (VEGF) and tumor necrosis factor alpha (TNF-α) expression in the eutopic endometrium of infertile patients with endometriosis within the window of implantation as a randomized exploratory trial. Subjects, who confirmed their endometriosis (stage III-IV) by a pathologist after laparoscopic surgery, were recruited to the present trial. A total of 34 patients were randomly divided into treatment (n = 17) and control (n = 17) groups, beside the routine protocol for treatment of endometriosis, they received resveratrol and placebo (400 mg) for 12-14 weeks, respectively. Endometrial tissue was collected from both groups before and after the intervention in the mid-secretory phase. Gene and protein expression levels of VEGF and TNF-α in the eutopic endometrium were assessed by Real-Time PCR and Western blotting, respectively. VEGF and TNF-α gene and protein levels in the treatment group showed significant decrease following intervention. It seems resveratrol may improve the endometrium of endometriosis patients in window of implantation period by modifying the expression of VEGF and TNF-α but further investigations are needed to reveal the potential role of this compound.",2021,VEGF and TNF-α gene and protein levels in the treatment group showed significant decrease following intervention.,"['infertile patients with endometriosis within the window of implantation', 'Subjects, who confirmed their endometriosis (stage III-IV) by a pathologist after laparoscopic surgery', '34 patients', 'endometriosis women']",['resveratrol and placebo'],"['Endometrial tissue', 'vascular endothelial growth factor (VEGF) and tumor necrosis factor alpha (TNF-α) expression', 'Gene and protein expression levels of VEGF and TNF-α in the eutopic endometrium', 'VEGF and TNF-α gene and protein levels']","[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0073096', 'cui_str': 'resveratrol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014180', 'cui_str': 'Endometrial structure'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}]",34.0,0.039154,VEGF and TNF-α gene and protein levels in the treatment group showed significant decrease following intervention.,"[{'ForeName': 'Mahshad', 'Initials': 'M', 'LastName': 'Khodarahmian', 'Affiliation': ""Infertility Department, Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran; Department of Anatomy, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Fardin', 'Initials': 'F', 'LastName': 'Amidi', 'Affiliation': 'Department of Anatomy, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Moini', 'Affiliation': ""Infertility Department, Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Ladan', 'Initials': 'L', 'LastName': 'Kashani', 'Affiliation': ""Infertility Department, Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran; Department of Anatomy, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Salahi', 'Affiliation': 'Department of Anatomy, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahla', 'Initials': 'S', 'LastName': 'Danaii-Mehrabad', 'Affiliation': 'Infertility Center, Academic Center for Education, Culture and Research, East Azarbaijan, Tabriz, Iran.'}, {'ForeName': 'Maryam Shabani', 'Initials': 'MS', 'LastName': 'Nashtaei', 'Affiliation': 'Department of Anatomy, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran; Infertility Department, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam Farid', 'Initials': 'MF', 'LastName': 'Mojtahedi', 'Affiliation': ""Infertility Department, Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Esfandyari', 'Affiliation': 'Department of Anatomy, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Aligholi', 'Initials': 'A', 'LastName': 'Sobhani', 'Affiliation': 'Department of Anatomy, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: sobhania@sina.tums.ac.ir.'}]",Journal of reproductive immunology,['10.1016/j.jri.2020.103248'] 1759,33393112,Novel Tumor Growth Rate Analysis in the Randomized CLARINET Study Establishes the Efficacy of Lanreotide Depot/Autogel 120 mg with Prolonged Administration in Indolent Neuroendocrine Tumors.,"INTRODUCTION Tumor quantity while receiving cancer therapy is the sum of simultaneous regression of treatment-sensitive and growth of treatment-resistant fractions at constant rates. Exponential rate constants for tumor regression/decay (d) and growth (g) can be estimated. Previous studies established g as a biomarker for overall survival; g increases after treatment cessation, can estimate doubling times, and can assess treatment effectiveness in small cohorts by benchmarking to large reference data sets. Using this approach, we analyzed data from the clinical trial CLARINET, evaluating lanreotide depot/autogel 120 mg/4 weeks (LAN) for treatment of neuroendocrine tumors (NETs). METHODS AND MATERIALS Computed tomography imaging data from 97 LAN- and 101 placebo-treated patients from CLARINET were analyzed to estimate g and d. RESULTS Data from 92% of LAN- and 94% of placebo-treated patients could be fit to one of the equations to derive g and d (p < .001 in most data sets). LAN-treated patients demonstrated significantly slower g than placebo recipients (p = .00315), a difference of 389 days in doubling times. No significant difference was observed in d. Over periods of LAN administration up to 700 days, g did not change appreciably. Simulated analysis with g as the endpoint showed a sample size of 48 sufficient to detect a difference in median g with 80% power. CONCLUSION Although treatment of NETs with LAN can affect tumor shrinkage, LAN primarily slows tumor growth rather than accelerates tumor regression. Evidence of LAN efficacy across tumors was identified. The growth-retarding effect achieved with LAN was sustained for a prolonged period of time. IMPLICATIONS FOR PRACTICE The only curative treatment for neuroendocrine tumors (NETs) is surgical resection; however, because of frequent late diagnosis, this is often impossible. Because of this, treatment of NETs is challenging and often aims to reduce tumor burden and delay progression. A novel method of analysis was used to examine data from the CLARINET trial, confirming lanreotide depot/autogel is effective at slowing tumor growth and extending progression-free survival. By providing the expected rate and doubling time of tumor growth early in the course of treatment, this method of analysis has the potential to guide physicians in their management of patients with NETs.",2021,"LAN-treated patients demonstrated significantly slower g than placebo recipients (P=.00315), a difference of 389 days in doubling times.",['Indolent Neuroendocrine Tumors'],"['LAN', 'NETs with LAN', 'placebo', 'placebo-treated patients from CLARINET', 'Lanreotide Depot', 'NETs', 'lanreotide depot/autogel 120 mg/4\u2009weeks (LAN']",['Exponential rate constants for tumor regression/decay (d) and growth (g'],"[{'cui': 'C0206754', 'cui_str': 'Neuroendocrine tumor'}]","[{'cui': 'C0209211', 'cui_str': 'lanreotide'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0206754', 'cui_str': 'Neuroendocrine tumor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]",,0.0825327,"LAN-treated patients demonstrated significantly slower g than placebo recipients (P=.00315), a difference of 389 days in doubling times.","[{'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Dromain', 'Affiliation': 'CHUV University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Loaiza-Bonilla', 'Affiliation': 'Cancer Treatment Centers of America, Boca Raton, Florida, USA.'}, {'ForeName': 'Beloo', 'Initials': 'B', 'LastName': 'Mirakhur', 'Affiliation': 'Ipsen Biopharmaceuticals, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Thomas J R', 'Initials': 'TJR', 'LastName': 'Beveridge', 'Affiliation': 'Ipsen Biopharmaceuticals, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Antonio Tito', 'Initials': 'AT', 'LastName': 'Fojo', 'Affiliation': 'Columbia University Medical Center, New York, New York, USA.'}]",The oncologist,['10.1002/onco.13669'] 1760,33350170,Predictive Significance of Serum Interferon Inducible Protein Score for Response to Treatment in Systemic Sclerosis Related Interstitial Lung Disease.,"OBJECTIVE Response to immunosuppression is highly variable in systemic sclerosis (SSc) related interstitial lung disease (ILD). We hypothesized that a composite serum Interferon Inducible Serum Protein Score would exhibit predictive significance for the response to immunosuppression in SSc-ILD. METHODS Serum samples collected in the Scleroderma Lung Study II, a randomized controlled trial of mycophenolate versus cyclophosphamide, were examined. Results were validated in an independent observational cohort on active treatment. A composite score of 6 interferon inducible proteins (IP-10, MIG, MCP-2, B2M, TNFR2, and MIP-3 beta) was calculated and its predictive significance for longitudinal forced vital capacity % predicted measurements was examined. RESULTS Higher baseline Interferon Inducible Protein Score predicted better response over 3 to 12-month visits in the mycophenolate (b=0.41, p=0.001) and cyclophosphamide (b=0.91, p=0.009) arms. In contrast, higher baseline c-reactive protein (CRP) levels predicted worse ILD course in both treatment arms. The predictive significance of Interferon Inducible Protein Score and CRP remained after adjustment for baseline demographic/clinical predictors. During the second-year placebo treatment period of the cyclophosphamide arm, higher Interferon Inducible Protein Score at 12 months showed a trend for predicting worse ILD course (b=-0.61, p=0.068) while it continued predicting better response to active immunosuppression in the mycophenolate arm (b=0.28, p=0.029). The predictive significance of baseline Interferon Inducible Protein Score was replicated in the independent cohort (r s =0.43; p=0.028). CONCLUSIONS Higher Interferon Inducible Protein Score in SSc-ILD predicts better response to immunosuppression and could be potentially used for identifying patients who may derive the most benefit from these two treatments.",2020,Higher Interferon Inducible Protein Score in SSc-ILD predicts better response to immunosuppression and could be potentially used for identifying patients who may derive the most benefit from these two treatments.,"['Serum samples collected in the Scleroderma Lung Study II', 'Systemic Sclerosis Related Interstitial Lung Disease']","['mycophenolate', 'mycophenolate versus cyclophosphamide', 'immunosuppression', 'cyclophosphamide', 'Serum Interferon Inducible Protein Score']","['higher baseline c-reactive protein (CRP) levels', 'higher Interferon Inducible Protein Score', 'composite score of 6 interferon inducible proteins (IP-10, MIG, MCP-2, B2M, TNFR2, and MIP-3 beta', 'Interferon Inducible Protein Score and CRP', 'baseline Interferon Inducible Protein Score']","[{'cui': 'C1550100', 'cui_str': 'Serum specimen'}, {'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}]","[{'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C1533698', 'cui_str': 'Nitric Oxide Synthase, Type II'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C1533698', 'cui_str': 'Nitric Oxide Synthase, Type II'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1308752', 'cui_str': 'CXCL10 protein, human'}, {'cui': 'C0215469', 'cui_str': 'CXCL9 protein, human'}, {'cui': 'C0214737', 'cui_str': 'CCL8 protein, human'}, {'cui': 'C0005149', 'cui_str': 'Beta 2 microglobulin'}, {'cui': 'C0255813', 'cui_str': 'Lymphocyte antigen CD120B'}, {'cui': 'C1701118', 'cui_str': 'CCL19 protein, human'}]",,0.0811254,Higher Interferon Inducible Protein Score in SSc-ILD predicts better response to immunosuppression and could be potentially used for identifying patients who may derive the most benefit from these two treatments.,"[{'ForeName': 'Shervin', 'Initials': 'S', 'LastName': 'Assassi', 'Affiliation': 'Department of Medicine, Division of Rheumatology, The University of Texas Health Science Center at Houston, USA.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Internal Medicine, University of California Los Angeles, USA.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Volkmann', 'Affiliation': 'Department of Medicine, Division of Rheumatology, University of California Los Angeles, USA.'}, {'ForeName': 'Maureen D', 'Initials': 'MD', 'LastName': 'Mayes', 'Affiliation': 'Department of Medicine, Division of Rheumatology, The University of Texas Health Science Center at Houston, USA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Rünger', 'Affiliation': 'Department of Internal Medicine, University of California Los Angeles, USA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ying', 'Affiliation': 'Department of Medicine, Division of Rheumatology, The University of Texas Health Science Center at Houston, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Roth', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care, University of California Los Angeles, USA.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Hinchcliff', 'Affiliation': 'Department of Medicine, Division of Rheumatology, Yale University, USA.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Khanna', 'Affiliation': 'Department of Medicine, Division of Rheumatology, University of Michigan, Ann Arbor, USA.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Frech', 'Affiliation': 'Department of Medicine, Division of Rheumatology, University of Utah, USA.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Clements', 'Affiliation': 'Department of Medicine, Division of Rheumatology, University of California Los Angeles, USA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Furst', 'Affiliation': 'Department of Medicine, Division of Rheumatology, University of California Los Angeles, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Goldin', 'Affiliation': 'Department of Radiological Sciences, University of California Los Angeles, USA.'}, {'ForeName': 'Elana J', 'Initials': 'EJ', 'LastName': 'Bernstein', 'Affiliation': 'Department of Medicine, Division of Rheumatology, Columbia University, USA.'}, {'ForeName': 'Flavia V', 'Initials': 'FV', 'LastName': 'Castelino', 'Affiliation': 'Department of Medicine, Division of Rheumatology, Massachusetts General Hospital, Harvard University, USA.'}, {'ForeName': 'Robyn T', 'Initials': 'RT', 'LastName': 'Domsic', 'Affiliation': 'Department of Medicine, Division of Rheumatology, Pittsburgh University, USA.'}, {'ForeName': 'Jessica K', 'Initials': 'JK', 'LastName': 'Gordon', 'Affiliation': 'Department of Medicine, Division of Rheumatology, Hospital for Special Surgery, USA, New York.'}, {'ForeName': 'Faye N', 'Initials': 'FN', 'LastName': 'Hant', 'Affiliation': 'Department of Medicine, Division of Rheumatology, Medical University of South Carolina, USA, Charleston.'}, {'ForeName': 'Ami A', 'Initials': 'AA', 'LastName': 'Shah', 'Affiliation': 'Department of Medicine, Division of Rheumatology, Johns Hopkins University School of Medicine, USA.'}, {'ForeName': 'Victoria K', 'Initials': 'VK', 'LastName': 'Shanmugam', 'Affiliation': 'Department of Medicine, Division of Rheumatology, George Washington University, USA.'}, {'ForeName': 'Virginia D', 'Initials': 'VD', 'LastName': 'Steen', 'Affiliation': 'Department of Medicine, Division of Rheumatology, Georgetown University, USA, Washington.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Elashoff', 'Affiliation': 'Department of Internal Medicine, University of California Los Angeles, USA.'}, {'ForeName': 'Donald P', 'Initials': 'DP', 'LastName': 'Tashkin', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care, University of California Los Angeles, USA.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41627'] 1761,33351989,Preoperative vaginal cleansing with chlorhexidine solution in preventing post-cesarean section infections in a low resource setting: A randomized controlled trial.,"INTRODUCTION Infection is one of the most common causes of maternal morbidities and mortality and has been reported to be responsible for about 15% of maternal deaths. Any woman is at risk of infection during childbirth, but women undergoing cesarean section are at higher risk. Improvement in surgical procedures with asepsis and the use of antibiotics have helped reduce postoperative infectious morbidities. However, ascending infection from the lower to the upper genital tract is a common but often neglected source of infection. Cleaning the vagina with chlorhexidine antiseptic solution before cesarean section can be a cheap and affordable source of infection control. This study is aimed at evaluating the efficacy of preoperative vaginal cleansing using 1.0% chlorhexidine in the reduction of post-cesarean section infectious morbidities. MATERIAL AND METHODS This prospective randomized control trial was conducted among 322 pregnant women who underwent an emergency cesarean section at Alex Ekwueme Federal University Teaching Hospital, Abakaliki (AE-FUTHA). The women were randomized into two groups. The interventional group received vaginal cleansing with three standard gauzes soaked in 30 mL 1.0% chlorhexidine gluconate solution preoperatively in addition to surgical skin cleaning with chlorhexidine-alcohol. The women in the control group only had surgical skin cleaning with chlorhexidine-alcohol. All the women received pre- and postoperative antibiotics. The primary outcomes were endometritis and wound infections. RESULTS Infectious morbidity was significantly reduced from 36.8% in the control group to 12.0% in the intervention group (P = .001). Endometritis occurred significantly less frequently in the intervention group than the control group (respectively 6.6% compared with 27.6%: relative risk [RR] 0.29, 95% confidence interval [CI] 0.16-0.53; P < .05). Foul-smelling vaginal discharge was significantly more common in the control group than in the intervention group (11.8% vs 1.3%, respectively) but the CI was wide (RR 8.5, 95% CI 1.30-64.55; P < .001). Fever and wound infection were more common in the control group (5.9% vs 3.3% and 9.2% vs 5.3%) but the difference was not significant. The hospital stay was significantly shorter among the intervention group (5.54 ± 1.04 days compared with 6.01 ± 1.55 days, P < 0.05). The most common microbial isolate implicated in endocervical colonization was Staphylococcus aureus followed by Klebsiella species. CONCLUSIONS Vaginal cleansing with 1.0% chlorhexidine gluconate solution before emergency cesarean section appears to be effective in reducing rates of post-cesarean section infectious morbidity in the study area. We recommend its use among women undergoing cesarean section to help reduce the contribution of infections to a poor obstetrics outcome.",2021,"RESULTS Infectious morbidity was significantly reduced from 36.8% in the control group to 12.0 % in the intervention group (P = 0.001).","['women undergoing cesarean section', '322 pregnant women that underwent an emergency cesarean section at Alex Ekwueme Federal University Teaching Hospital, Abakaliki (AE-FUTHA']","['Vaginal cleansing with 1.0% chlorhexidine gluconate solution', 'chlorhexidine solution', 'vaginal cleansing with three standard gauzes soaked in 30ml 1.0% chlorhexidine gluconate solution pre-operatively in addition to surgical skin cleaning with chlorhexidine-alcohol', 'chlorhexidine-alcohol', 'chlorhexidine', 'chlorhexidine antiseptic solution', 'preoperative vaginal cleansing']","['Endometritis', 'post-cesarean section infections', 'Fever and wound infection', 'rates of post- cesarean section infectious morbidity', 'endometritis and wound infections', 'Foul-smelling vaginal discharge', 'hospital stay', 'surgical skin cleaning', 'Infectious morbidity']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C4517712', 'cui_str': '322'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0558380', 'cui_str': 'Emergency cesarean section'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0055361', 'cui_str': 'Chlorhexidine gluconate'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0590323', 'cui_str': 'Gauzes'}, {'cui': 'C0204774', 'cui_str': 'Soak'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0574729', 'cui_str': 'Skin clean'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0003205', 'cui_str': 'Antiseptic agent'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0014179', 'cui_str': 'Endometritis'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0227791', 'cui_str': 'Vaginal discharge'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}]",322.0,0.093591,"RESULTS Infectious morbidity was significantly reduced from 36.8% in the control group to 12.0 % in the intervention group (P = 0.001).","[{'ForeName': 'Christian O', 'Initials': 'CO', 'LastName': 'Ogah', 'Affiliation': 'Department of Obstetrics and Gynecology, Alex Ekwueme Federal University Teaching Hospital, Abakaliki, Nigeria.'}, {'ForeName': 'Chidebe C', 'Initials': 'CC', 'LastName': 'Anikwe', 'Affiliation': 'Department of Obstetrics and Gynecology, Alex Ekwueme Federal University Teaching Hospital, Abakaliki, Nigeria.'}, {'ForeName': 'Leonard O', 'Initials': 'LO', 'LastName': 'Ajah', 'Affiliation': 'Department of Obstetrics and Gynecology, Alex Ekwueme Federal University Teaching Hospital, Abakaliki, Nigeria.'}, {'ForeName': 'Arinze C', 'Initials': 'AC', 'LastName': 'Ikeotuonye', 'Affiliation': 'Department of Obstetrics and Gynecology, Alex Ekwueme Federal University Teaching Hospital, Abakaliki, Nigeria.'}, {'ForeName': 'Osaheni L', 'Initials': 'OL', 'LastName': 'Lawani', 'Affiliation': 'Department of Obstetrics and Gynecology, Alex Ekwueme Federal University Teaching Hospital, Abakaliki, Nigeria.'}, {'ForeName': 'Bartholomew C', 'Initials': 'BC', 'LastName': 'Okorochukwu', 'Affiliation': 'Department of Obstetrics and Gynecology, Federal Medical Center, Owerri, Nigeria.'}, {'ForeName': 'Cyril C', 'Initials': 'CC', 'LastName': 'Ikeoha', 'Affiliation': 'Department of Obstetrics and Gynecology, Alex Ekwueme Federal University Teaching Hospital, Abakaliki, Nigeria.'}, {'ForeName': 'Francis C', 'Initials': 'FC', 'LastName': 'Okoroafor', 'Affiliation': 'Department of Obstetrics and Gynecology, Alex Ekwueme Federal University Teaching Hospital, Abakaliki, Nigeria.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.14060'] 1762,33347003,"Safe and Effective Chin Augmentation With the Hyaluronic Acid Injectable Filler, VYC-20L.","BACKGROUND VYC-20L is a hyaluronic acid soft tissue filler with lidocaine designed to restore facial volume. OBJECTIVE Evaluate the safety and effectiveness of VYC-20L in patients with chin retrusion. MATERIALS AND METHODS Adults with chin retrusion were randomized (3:1) to receive VYC-20L in the chin at study onset (treatment group) or 6 months later (control group). The primary effectiveness end point was ≥1-point improvement on the Allergan Chin Retrusion Scale (ACRS) from baseline at Month 6. Safety assessments included injection site responses (ISRs) and adverse events (AEs). RESULTS VYC-20L was administered to 192 participants (treatment group, n = 144; control group, n = 48). At Month 6, significantly more participants had an ACRS response in the treatment versus control group (56.3% vs 27.5%; p = .0019). Effectiveness was also demonstrated by the proportion of participants with improved/much improved Global Aesthetic Improvement Scale scores and responses on the FACE-Q Satisfaction with Chin questionnaire and FACE-Q Psychological Wellbeing module. Treatment benefit remained evident at Month 12. Most common ISRs were tenderness (81.1%) and firmness (75.1%). One participant (0.5%) discontinued the study due to 2 treatment-related serious AEs of facial cellulitis and injection site inflammation, both resolved without sequelae. CONCLUSION VYC-20L significantly improved an ACRS response and was generally safe and well tolerated.",2021,"At Month 6, significantly more participants had an ACRS response in the treatment versus control group (56.3% vs 27.5%; p = .0019).","['Adults with chin retrusion', 'patients with chin retrusion']","['lidocaine', 'Hyaluronic Acid Injectable Filler, VYC-20L', 'VYC-20L']","['ACRS response', 'Safe and Effective Chin Augmentation', 'safety and effectiveness', 'injection site responses (ISRs) and adverse events (AEs', 'Global Aesthetic Improvement Scale scores and responses on the FACE-Q Satisfaction with Chin questionnaire and FACE-Q Psychological Wellbeing module', 'Allergan Chin Retrusion Scale (ACRS', 'safe and well tolerated']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008114', 'cui_str': 'Chin structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0729441', 'cui_str': 'Filler'}]","[{'cui': 'C0008114', 'cui_str': 'Chin structure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0185696', 'cui_str': 'Augmentation genioplasty'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0221208', 'cui_str': 'Injection site'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C3542953', 'cui_str': 'Module'}]",192.0,0.0292577,"At Month 6, significantly more participants had an ACRS response in the treatment versus control group (56.3% vs 27.5%; p = .0019).","[{'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Beer', 'Affiliation': 'Beer Dermatology, West Palm Beach, Florida.'}, {'ForeName': 'Joely', 'Initials': 'J', 'LastName': 'Kaufman-Janette', 'Affiliation': 'Skin Associates of South Florida, Coral Gables, Florida.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bank', 'Affiliation': 'The Center for Dermatology, Cosmetic & Laser Surgery, Mount Kisco, New York.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Biesman', 'Affiliation': 'Private Practice, Nashville, Tennessee.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Dayan', 'Affiliation': 'DeNova Research, Chicago, Illinois.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Kim', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Chawla', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Schumacher', 'Affiliation': 'Allergan plc, Irvine, California.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002795'] 1763,33358350,Intermittent Administration of Nitroglycerin Sublingual Powder Compared with Placebo in Outpatients with Peripheral Artery Disease: Results of a Randomised Proof of Concept Study.,"OBJECTIVE Treatment of peripheral artery disease (PAD), Fontaine Stage IIb with vasoactive substances is of limited efficacy and does not last beyond the active treatment. Glyceryl trinitrate (GTN) is a vasodilating agent that relaxes vascular smooth muscle cells. The aim was to prove the concept that GTN sublingual powder has sustained clinical efficacy and adequate safety in these patients. METHODS This was a multicentre, randomised, double blind, placebo controlled, forced titration, proof of concept study (phase IIa). Patients had a treadmill test at baseline, after 12 weeks of GTN/placebo administration, and at 19 and 26 weeks (without treatment). Primary objectives were an increase in initial claudication distance (ICD) and absolute claudication distance (ACD) at 12 weeks. RESULTS Ninety-five patients were screened and 73 randomised, of which 53 patients completed the 12 week treatment phase (GTN 26, placebo 27). At a baseline ICD of 59.2 ± 32.8 m (GTN) and 57.5 ± 39.7 m (placebo), GTN led to a placebo corrected ICD increase of 23.2% vs. baseline (p = .35). Baseline ACD was 105.3 ± 52.9 m (GTN) and 106.1 ± 95.0 m (placebo), and GTN led to a placebo corrected increase of 3.6% (p = .44), with substantial interindividual variation. The change in claudication distance was greater in patients with an ICD of ≥50 m at baseline (ΔICD 29.3%; p = .19), and an ACD ≥ 100 m (ΔACD 8.5%; p = .40). The effect lasted beyond the active treatment period as shown by a 49.3% increase in ICD (p = .31) and a 20.6% increase in ACD (p = .21) by week 26. GTN sublingual powder was well tolerated. CONCLUSION Intermittent treatment with nitroglycerin sublingual powder may represent a potential treatment option for patients with PAD stage Fontaine IIb, with an immediate and a sustained effect. The observed increases in ACD and ICD were however not statistically significant in this phase IIa proof of concept study. Further studies are required.",2021,GTN led to a placebo corrected ICD increase of 23.2% vs. baseline (p = .35).,"['Ninety-five patients', 'patients with PAD stage Fontaine IIb', 'Outpatients with Peripheral Artery Disease', 'peripheral artery disease (PAD']","['GTN/placebo', 'placebo', 'Glyceryl trinitrate (GTN', 'Placebo', 'Nitroglycerin Sublingual Powder', 'nitroglycerin sublingual powder']","['ICD', 'ACD', 'initial claudication distance (ICD) and absolute claudication distance (ACD', 'tolerated', 'claudication distance', 'ACD and ICD']","[{'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4283725', 'cui_str': 'Nitroglycerin Sublingual Powder'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0429887', 'cui_str': 'Claudication distance'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}]",95.0,0.515264,GTN led to a placebo corrected ICD increase of 23.2% vs. baseline (p = .35).,"[{'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Lawall', 'Affiliation': 'Gemeinschaftspraxis Diehm/Lawall, Ettlingen, Germany. Electronic address: holger.lawall@gmail.com.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bramlage', 'Affiliation': 'Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Gorath', 'Affiliation': 'G. Pohl-Boskamp GmbH & Co. KG, Hohenlockstedt, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wittig', 'Affiliation': 'G. Pohl-Boskamp GmbH & Co. KG, Hohenlockstedt, Germany.'}]",European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery,['10.1016/j.ejvs.2020.11.024'] 1764,33355637,Random Survival Forests Analysis of Intraoperative Complications as Predictors of Descemet Stripping Automated Endothelial Keratoplasty Graft Failure in the Cornea Preservation Time Study.,"Importance A new analytic method can evaluate factors of interest associated with graft failure after Descemet stripping automated endothelial keratoplasty (DSAEK) or more generally in any ophthalmic surgical setting with a time-to-event outcome. Objective To reanalyze types of intraoperative complications associated with DSAEK graft failure in the Cornea Preservation Time Study using random survival forests. Design, Setting, and Participants This cohort study, initially conceived in April 2019, used a prediction model to conduct a post hoc secondary analysis of data collected in a multicenter, double-masked, randomized clinical trial. Forty US clinical sites with 70 surgeons participated, with donor corneas provided by 23 US eye banks. The study included 1090 participants, representing 1330 eyes, undergoing DSAEK for Fuchs dystrophy (1255 eyes [94.4%]) or pseudophakic or aphakic corneal edema (75 eyes [5.6%]). Enrollment occurred between April 16, 2012, and February 20, 2014, and follow-up ended June 5, 2017. Statistical analysis was performed from July 10, 2019, to May 29, 2020. Intervention Descemet stripping automated endothelial keratoplasty with random assignment of a donor cornea with preservation time of 7 days or less or 8 to 14 days. Main Outcomes and Measures Ranked variable importance for intraoperative complications among 50 donor, recipient, and eye bank variables and restricted mean survival time through 47 months (1434 days) after DSAEK were examined. Random survival forests, a nonparametric method (with less restrictive model assumptions) that is far more flexible in its ability to model nonlinear effects and interactions, was used to analyze the data. Results This study included 1090 participants (663 women [60.8%]; median age, 70 years [range, 42-90 years]), representing 1330 eyes. Random survival forests ranked a DSAEK intraoperative complication as the third most predictive factor of graft failure, after surgeon and eye bank, in the final model with 5 predictors. In the first 47 months after DSAEK, the estimated mean difference in restricted mean survival time for grafts that experienced a DSAEK intraoperative complication vs those that did not was -227 days (99% CI, -352 to -70 days) based on the final RSF model. Conclusions and Relevance These findings, while post hoc, support the hypothesis that random survival forests allow for an improved analytic approach for identifying factors predictive of graft failure and for obtaining adjusted graft survival estimates. Random survival forests offer the opportunity to guide the development of future population-based cohort ophthalmic surgical studies, establishing definitive factors for procedural success.",2021,"Random survival forests ranked a DSAEK intraoperative complication as the third most predictive factor of graft failure, after surgeon and eye bank, in the final model with 5 predictors.","['1090 participants (663 women [60.8%]; median age, 70 years [range, 42-90 years]), representing 1330 eyes', '1090 participants, representing 1330 eyes, undergoing DSAEK for Fuchs dystrophy (1255 eyes [94.4%]) or pseudophakic or aphakic corneal edema (75 eyes [5.6', '70 surgeons participated, with donor corneas provided by 23 US eye banks']",['Descemet stripping automated endothelial keratoplasty (DSAEK'],"['intraoperative complications among 50 donor, recipient, and eye bank variables and', 'mean survival time']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C2366835', 'cui_str': 'Endothelial keratoplasty'}, {'cui': 'C0026850', 'cui_str': 'Muscular dystrophy'}, {'cui': 'C0339264', 'cui_str': 'Aphakic corneal edema'}, {'cui': 'C4517794', 'cui_str': '5.6'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0010031', 'cui_str': 'Corneal structure'}, {'cui': 'C0015394', 'cui_str': 'Eye Banks'}]","[{'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C2366835', 'cui_str': 'Endothelial keratoplasty'}]","[{'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0015394', 'cui_str': 'Eye Banks'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0086595', 'cui_str': 'Mean Survival Time'}]",1090.0,0.317854,"Random survival forests ranked a DSAEK intraoperative complication as the third most predictive factor of graft failure, after surgeon and eye bank, in the final model with 5 predictors.","[{'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Data Science, University of Mississippi Medical Center, Jackson.'}, {'ForeName': 'Hemant', 'Initials': 'H', 'LastName': 'Ishwaran', 'Affiliation': 'Division of Biostatistics, Department of Public Health Sciences, University of Miami, Miami, Florida.'}, {'ForeName': 'Loretta B', 'Initials': 'LB', 'LastName': 'Szczotka-Flynn', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Jonathan H', 'Initials': 'JH', 'LastName': 'Lass', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.5743'] 1765,33819289,Safety and glycemic outcomes of do-it-yourself AndroidAPS hybrid closed-loop system in adults with type 1 diabetes.,"BACKGROUND The aim of the study was to assess the safety and glycemic outcomes with the use of a Do-It-Yourself (DIY) Hybrid Closed-Loop (HCL) system based on the AndroidAPS application in type 1 diabetes (T1D). METHODS Single-center clinical trial, with 3-week run-in and 12-week study period. DIY HCL system consisted of the Dana Diabecare RS insulin pump, Dexcom G5 continuous glucose monitoring system and AndroidAPS application. Primary outcome was safety: incidences of severe hypoglycemia, diabetic ketoacidosis, time spent in glycemia <54 mg/dl. Secondary endpoints included percentage of time in range (TIR) 70-180 mg/dl, time below 70 mg/dl, HbA1c, insulin requirements, and body weight. RESULTS In total 12 subjects (5 men, 7 women) were enrolled, mean age 31.3±6.7, 95%CI(27.7-34.9) years, mean diabetes duration 16.1±5.7, 95%CI(13.0-19.2) years. No episodes of severe hypoglycemia or ketoacidosis were observed. Percentage of time spent in glycemia below 54mg/dl was not increased. Average sensor glycemia was lower in the study period than baseline (141.1 ± 8.4, 95%CI(136.3-145.9) vs. 153.3 ± 17.9, 95%CI(143.2-163.4), mg/dl p<0.001). TIR 70-180 mg/dl was improved by 11.3%, 95%CI(2.8%-19.8%) (from 68.0 ± 12.7 to 79.3 ± 6.4%, p<0.001), without increasing hypoglycemia time. The HbA1c level decreased by -0.5%, 95%CI(-0.9%--0.1%) (from 6.8 ± 0.5 to 6.3 ± 0.4%, p<0.001). Additionally, in the last 4 weeks of the study period participants significantly improved and showed TIR 70-180 mg/dl 82.1 ± 5.6%, 95%CI(78.9-85.3), time <54 mg/dl 0.30 (0.20-0.55)%, median 95%CI(0.1-0.7) and <70 mg/dl 1.90 (1.10-3.05)%, median 95%CI(0.7-3.2). The insulin requirement and body weight did not change in the study. CONCLUSIONS The study revealed safety of the Do-It-Yourself HCL system AndroidAPS in adults with T1D, limited to well-controlled, highly selected and closely monitored patients. The use of AndroidAPS significantly improved HbA1c, time in range and average sensor glycemia without increasing hypoglycemia. As both patients and their medical team are gaining experience using the system over time, they improve glycemic control. TRIAL REGISTRATION German Clinical Trials Register: no. DRKS00015439; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00015439.",2021,The study revealed safety of the Do-It-Yourself HCL system,"['adults with T1D', 'adults with type 1 diabetes', 'In total 12 subjects (5 men, 7 women) were enrolled, mean age 31.3±6.7, 95%CI(27.7-34.9) years, mean diabetes duration 16.1±5.7, 95%CI(13.0-19.2) years']","['it-yourself AndroidAPS hybrid closed-loop system', 'It-Yourself (DIY', 'Hybrid Closed-Loop (HCL) system', 'AndroidAPS', 'Do-It-Yourself HCL system']","['percentage of time in range (TIR) 70-180 mg/dl, time below 70 mg/dl, HbA1c, insulin requirements, and body weight', 'HbA1c level', 'insulin requirement and body weight', 'Average sensor glycemia', 'HbA1c, time in range and average sensor glycemia without increasing hypoglycemia', 'safety: incidences of severe hypoglycemia, diabetic ketoacidosis, time spent in glycemia <54 mg/dl', 'Safety and glycemic outcomes', 'hypoglycemia time', 'safety and glycemic outcomes', 'severe hypoglycemia or ketoacidosis']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]","[{'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.19355,The study revealed safety of the Do-It-Yourself HCL system,"[{'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Gawrecki', 'Affiliation': 'Department of Internal Medicine and Diabetology, Poznan University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Zozulinska-Ziolkiewicz', 'Affiliation': 'Department of Internal Medicine and Diabetology, Poznan University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Magdalena A', 'Initials': 'MA', 'LastName': 'Michalak', 'Affiliation': 'Department of Diabetology and Internal Medicine, Raszeja Hospital, Poznan, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Adamska', 'Affiliation': 'Department of Internal Medicine and Diabetology, Poznan University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Michalak', 'Affiliation': 'Department of Computer Sciences and Statistics, Poznan University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Urszula', 'Initials': 'U', 'LastName': 'Frackowiak', 'Affiliation': 'Department of Diabetology and Internal Medicine, Raszeja Hospital, Poznan, Poland.'}, {'ForeName': 'Justyna', 'Initials': 'J', 'LastName': 'Flotynska', 'Affiliation': 'Department of Internal Medicine and Diabetology, Poznan University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Pietrzak', 'Affiliation': 'Department of Diabetology and Internal Medicine, Raszeja Hospital, Poznan, Poland.'}, {'ForeName': 'Szymon', 'Initials': 'S', 'LastName': 'Czapla', 'Affiliation': 'Nightscout Poland, Kielce, Poland.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Gehr', 'Affiliation': 'Zentrum für Diabetes und Stoffwechselerkrankungen, m&i Fachklinik, Bad Heilbrunn, Germany.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Araszkiewicz', 'Affiliation': 'Department of Internal Medicine and Diabetology, Poznan University of Medical Sciences, Poznan, Poland.'}]",PloS one,['10.1371/journal.pone.0248965'] 1766,33359595,"Evaluation of platelet-rich plasma on hair regrowth and lesional T-cell cytokine expression in alopecia areata: A randomized observer-blinded, placebo-controlled, split-head pilot study.","BACKGROUND Platelet-rich plasma has shown some promise in the treatment of alopecia areata. OBJECTIVE To evaluate the effect of platelet-rich plasma on hair regrowth and lesional T-cell cytokine expression in alopecia areata. METHODS This was a randomized, placebo-controlled, split-head study involving 27 patients with alopecia areata (Severity of Alopecia Tool score ≥25%). Alopecia patches on either side of the scalp were randomized to receive 3 intradermal injections of platelet-rich plasma or normal saline at monthly intervals and evaluated 3 months after the last session. Lesional T-cell cytokine messenger RNA expression was compared pre- and posttreatment in the platelet-rich plasma-treated sites. RESULTS The mean Severity of Alopecia Tool score did not change significantly compared with baseline with either platelet-rich plasma or placebo injections at any visit; however, the mean percentage reduction in the score in the platelet-rich plasma arm was more than in the placebo arm (9.05% ± 36.48% vs 4.99% ± 33.88%; P = .049) at final assessment. The mean interferon gamma (P = .001) and interleukin 17 cytokine (P = .009) messenger RNA expression decreased, whereas the mean interleukin 10 (P = .049) and FOXP3 (P = .011) messenger RNA expression increased significantly after platelet-rich plasma treatment. LIMITATIONS Small sample size and a relatively short follow-up. CONCLUSION Platelet-rich plasma was found to have limited efficacy in alopecia areata. However, it may play a role in restoring immune balance in the alopecic patches.",2021,"The mean IFN-gamma (p=0.001) and IL-17 cytokine (p=0.009) mRNA expression decreased, while the mean IL-10 (p=0.049) and FoxP3 (p=0.011) mRNA expression increased significantly after PRP treatment. ","['27 patients with alopecia areata (SALT>25', 'alopecia areata']","['Platelet-rich plasma (PRP', 'PRP', 'placebo', 'platelet-rich plasma', 'PRP or normal saline']","['mean SALT score', 'IL-17 cytokine (p=0.009) mRNA expression', 'Alopecia patches', 'SALT score', 'mean IFN-gamma', 'FoxP3', 'mean IL-10', 'Lesional T-cell cytokine mRNA expression', 'hair regrowth and lesional T-cell cytokine expression', 'mRNA expression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}]",27.0,0.124138,"The mean IFN-gamma (p=0.001) and IL-17 cytokine (p=0.009) mRNA expression decreased, while the mean IL-10 (p=0.049) and FoxP3 (p=0.011) mRNA expression increased significantly after PRP treatment. ","[{'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Gupta', 'Affiliation': 'Department of Dermatology and Venereology, All India Institute of Medical Sciences, New Delhi, India. Electronic address: doctor.vishalgupta@gmail.com.'}, {'ForeName': 'Anita Singh', 'Initials': 'AS', 'LastName': 'Parihar', 'Affiliation': 'Department of Dermatology and Venereology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Vinod Kumar', 'Initials': 'VK', 'LastName': 'Sharma', 'Affiliation': 'Department of Dermatology and Venereology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Department of Physiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Vishwajeet', 'Initials': 'V', 'LastName': 'Singh', 'Affiliation': 'Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Neena', 'Initials': 'N', 'LastName': 'Khanna', 'Affiliation': 'Department of Dermatology and Venereology, All India Institute of Medical Sciences, New Delhi, India.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.12.039'] 1767,33368855,The cost-effectiveness of dapagliflozin in treating high-risk patients with type 2 diabetes mellitus: An economic evaluation using data from the DECLARE-TIMI 58 trial.,"AIM To undertake a cost-effectiveness analysis of dapagliflozin in treating high-risk patients with type 2 diabetes mellitus (T2DM), using both directly observed events in the DECLARE-TIMI 58 trial and surrogate risk factors to predict endpoints not captured within the trial. METHODS An established T2DM model was adapted to integrate survival curves derived from the DECLARE-TIMI 58 trial, and extrapolated over a lifetime for all-cause mortality, hospitalization for heart failure, stroke, myocardial infarction, hospitalization for unstable angina, and end-stage kidney disease. The economic analysis considered the overall DECLARE trial population, as well as reported patient subgroups. Total and incremental costs, life-years and quality-adjusted life-years associated with dapagliflozin versus placebo were estimated from the perspective of the UK healthcare payer. RESULTS In the UK setting, treatment with dapagliflozin compared to placebo was estimated to be dominant, with an expected increase in quality-adjusted life-years from 10.43 to 10.48 (+0.06) and a reduction in lifetime total costs from £39 451 to £36 899 (-£2552). Across all patient subgroups, dapagliflozin was estimated to be dominant, with the greatest absolute benefit in the prior heart failure subgroup (incremental lifetime costs -£4150 and quality-adjusted life-years +0.11). CONCLUSIONS The results of this study demonstrate that dapagliflozin compared to placebo appears to be cost-effective, when considering evidence reported from the DECLARE-TIMI 58 trial, at established UK willingness-to-pay thresholds. The findings highlight the potential of dapagliflozin to have a meaningful impact in reducing the economic burden of T2DM and its associated complications across a broad T2DM population.",2021,"Across all patient subgroups, dapagliflozin was estimated to be dominant with the greatest absolute benefit in the prior heart failure subgroup (incremental lifetime costs -£4150 and quality adjusted life years +0.11). ","['risk patients with type 2 diabetes mellitus (T2DM', 'risk patients with type 2 diabetes mellitus']","['dapagliflozin', 'dapagliflozin versus placebo', 'placebo']","['Total and incremental costs, life years and quality-adjusted life years', 'cost-effectiveness', 'quality-adjusted life-years', 'lifetime total costs']","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.117168,"Across all patient subgroups, dapagliflozin was estimated to be dominant with the greatest absolute benefit in the prior heart failure subgroup (incremental lifetime costs -£4150 and quality adjusted life years +0.11). ","[{'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'McEwan', 'Affiliation': 'Health Economics and Outcomes Research Ltd, Cardiff, UK.'}, {'ForeName': 'Angharad R', 'Initials': 'AR', 'LastName': 'Morgan', 'Affiliation': 'Health Economics and Outcomes Research Ltd, Cardiff, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Boyce', 'Affiliation': 'Health Economics and Outcomes Research Ltd, Cardiff, UK.'}, {'ForeName': 'Klas', 'Initials': 'K', 'LastName': 'Bergenheim', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Ingrid A M', 'Initials': 'IAM', 'LastName': 'Gause-Nilsson', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Johansson', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Avivit', 'Initials': 'A', 'LastName': 'Cahn', 'Affiliation': 'Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'John P H', 'Initials': 'JPH', 'LastName': 'Wilding', 'Affiliation': 'University of Liverpool, Liverpool, UK.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14308'] 1768,33373078,The pre-efficacy phase testing for PAfitME™-A behavioral physical activity intervention to manage moderate and severe symptoms among advanced stage cancer patients.,"Fatigue and pain are the most frequently reported symptoms among advanced-stage cancer patients. Although physical activity (PA) is known to improve the aforementioned symptoms, few patients demonstrate the physically active behavior that adheres to the clinical guidelines regarding PA. The current article presents an exemplar that used the National Institute of Health's Obesity-Related Behavioral Intervention Trial (ORBIT) model and developed a behavioral intervention known as the personalized Physical Activity intervention with fitness graded Motion Exergames (PAfitME™). There were two phases of testing in the ORBIT model presented in the current paper. In Phase I testing, a standardized exergame prescription was evaluated by an advisory board and a single-case study was used to evaluate the personalized exergame prescription with personalization of the fitness levels. In Phase IIa, a within-group pre- and posttest design was used to evaluate the personalized exergame prescriptions with personalization of the fitness levels, self-efficacy, and variation in fatigue/pain. Subsequently, a complete intervention package was developed in accordance with a logic model, driven from the result of the Phase IIa testing with clinically significant findings. Currently, PAfitME™ is under Phase IIb testing in a randomized clinical trial with a control group. PAfitME™ employs a personalized approach to initiate and promote physically active behavior, to facilitate the management of fatigue and pain in cancer patients. Positive results from an efficacy trial would support the use of PAfitME™ in the management of fatigue and pain in advanced-stage cancer patients.",2021,"PAfitME™ employs a personalized approach to initiate and promote physically active behavior, to facilitate the management of fatigue and pain in cancer patients.","['advanced stage cancer patients', 'cancer patients', 'advanced-stage cancer patients']","['PAfitME', 'PAfitME™-A behavioral physical activity intervention']","['Fatigue and pain', 'fatigue and pain']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0027646', 'cui_str': 'Cancer staging'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.036288,"PAfitME™ employs a personalized approach to initiate and promote physically active behavior, to facilitate the management of fatigue and pain in cancer patients.","[{'ForeName': 'Hsiao-Lan', 'Initials': 'HL', 'LastName': 'Wang', 'Affiliation': 'College of Nursing, University of South Florida, Tampa, Florida, USA.'}, {'ForeName': 'Kristine A', 'Initials': 'KA', 'LastName': 'Donovan', 'Affiliation': 'Moffitt Cancer Center, Tampa, Florida, USA.'}, {'ForeName': 'Sahana', 'Initials': 'S', 'LastName': 'Rajasekhara', 'Affiliation': 'Moffitt Cancer Center, Tampa, Florida, USA.'}, {'ForeName': 'Tapan', 'Initials': 'T', 'LastName': 'Padhya', 'Affiliation': 'College of Medicine, University of South Florida, Tampa, Florida, USA.'}, {'ForeName': 'Harleah G', 'Initials': 'HG', 'LastName': 'Buck', 'Affiliation': 'College of Nursing, University of South Florida, Tampa, Florida, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Szalacha', 'Affiliation': 'College of Nursing, University of South Florida, Tampa, Florida, USA.'}, {'ForeName': 'J Morris', 'Initials': 'JM', 'LastName': 'Chang', 'Affiliation': 'College of Engineering, University of South Florida, Tampa, Florida, USA.'}, {'ForeName': 'Jaelyn D', 'Initials': 'JD', 'LastName': 'Brown', 'Affiliation': 'College of Nursing, University of South Florida, Tampa, Florida, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Smith', 'Affiliation': 'College of Nursing, University of South Florida, Tampa, Florida, USA.'}]",Research in nursing & health,['10.1002/nur.22099'] 1769,33371716,Erratum to A Prospective Randomized Trial of N-butyl-cyanoacrylate + Metacryloxysulfolane Adhesive versus Suture Alone for Grafting in Rhinoplasty: 9 year Follow-up.,,2020,,[],['N-butyl-cyanoacrylate + Metacryloxysulfolane Adhesive versus Suture Alone'],[],[],"[{'cui': 'C0014035', 'cui_str': 'Enbucrilate'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}]",[],,0.0180204,,[],"The Annals of otology, rhinology, and laryngology",['10.1177/0003489420962699'] 1770,33370201,"Letter by Halenarova and Taccone Regarding Article ""Impact of Goal-Directed Therapy on Delayed Ischemia After Aneurysmal Subarachnoid Hemorrhage: Randomized Controlled Trial"".",,2021,,['After Aneurysmal Subarachnoid Hemorrhage'],[],['Delayed Ischemia'],"[{'cui': 'C0751530', 'cui_str': 'Subarachnoid Hemorrhage, Aneurysmal'}]",[],"[{'cui': 'C0022116', 'cui_str': 'Ischemia'}]",,0.24011,,"[{'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Halenarova', 'Affiliation': 'Department of Intensive Care, Hopital Erasme, Route de Lennik, Belgium.'}, {'ForeName': 'Fabio Silvio', 'Initials': 'FS', 'LastName': 'Taccone', 'Affiliation': 'Department of Intensive Care, Hopital Erasme, Route de Lennik, Belgium.'}]",Stroke,['10.1161/STROKEAHA.120.032465'] 1771,33370197,"Letter by Goyal and Ospel Regarding Article, ""Direct Transfer to Angio-Suite Versus Computed Tomography-Transit in Patients Receiving Mechanical Thrombectomy: a Randomized Trial"".",,2021,,['Patients Receiving Mechanical Thrombectomy'],"['Letter by Goyal and Ospel Regarding Article, ""Direct Transfer to Angio-Suite Versus Computed Tomography-Transit']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}]","[{'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1301827', 'cui_str': 'In transit'}]",[],,0.0237327,,"[{'ForeName': 'Mayank', 'Initials': 'M', 'LastName': 'Goyal', 'Affiliation': 'Department of Clinical Neurosciences (M.G., J.M.O.), University of Calgary, Canada.'}, {'ForeName': 'Johanna M', 'Initials': 'JM', 'LastName': 'Ospel', 'Affiliation': 'Department of Clinical Neurosciences (M.G., J.M.O.), University of Calgary, Canada.'}]",Stroke,['10.1161/STROKEAHA.120.032216'] 1772,33370185,"Letter by van der Jagt and Suarez Regarding Article, ""Impact of Goal-Directed Therapy on Delayed Ischemia After Aneurysmal Subarachnoid Hemorrhage: Randomized Controlled Trial"".",,2021,,['After Aneurysmal Subarachnoid Hemorrhage'],[],['Delayed Ischemia'],"[{'cui': 'C0751530', 'cui_str': 'Subarachnoid Hemorrhage, Aneurysmal'}]",[],"[{'cui': 'C0022116', 'cui_str': 'Ischemia'}]",,0.181788,,"[{'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'van der Jagt', 'Affiliation': 'Department of Intensive Care Adults, Erasmus MC-University Medical Center, Rotterdam, the Netherlands (M.v.d.J.).'}, {'ForeName': 'Jose I', 'Initials': 'JI', 'LastName': 'Suarez', 'Affiliation': 'Departments of Anesthesiology and Critical Care Medicine, Neurology, and Neurosurgery, The Johns Hopkins University School of Medicine, Baltimore, MD (J.I.S.).'}]",Stroke,['10.1161/STROKEAHA.120.032082'] 1773,33370179,"Response by Pfaff et al to Letter Regarding Article, ""Direct Transfer to Angio-Suite Versus Computed Tomography-Transit in Patients Receiving Mechanical Thrombectomy: a Randomized Trial"".",,2021,,['Patients Receiving Mechanical Thrombectomy'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}]",[],[],,0.0194033,,"[{'ForeName': 'Johannes A R', 'Initials': 'JAR', 'LastName': 'Pfaff', 'Affiliation': 'Department of Neuroradiology, Heidelberg University Hospital, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bendszus', 'Affiliation': 'Department of Neuroradiology, Heidelberg University Hospital, Germany.'}, {'ForeName': 'Markus A', 'Initials': 'MA', 'LastName': 'Möhlenbruch', 'Affiliation': 'Department of Neuroradiology, Heidelberg University Hospital, Germany.'}]",Stroke,['10.1161/STROKEAHA.120.032798'] 1774,33369462,Effects of Mefenamic Acid in Pain Control during Loop Electrical Excision Procedure:A Prospective Double-Blind Randomized Control Trial.,"OBJECTIVE To investigate the effectiveness of pre-procedural oral mefenamic acid compared with placebo in women undergoing Loop Electrosurgical Excision Procedure (LEEP) with intracervical lidocaine injection. STUDY DESIGNS A prospective double-blinded randomized control trial. Materials, Setting, Methods: Women undergoing LEEP for any indications were asked to participate in the study. The participants were randomly allocated into two groups. In group 1 (oral mefenamic acid), the participants were offered oral mefenamic acid (500 mg) for 30 minutes before procedures. In group 2 (placebo), the patients were given oral placebo (identical tablet) for 30 minutes before operation. All participants received immediate 10 mL of 2% lidocaine with 1:100,000 of epinephrine intracervical injection before undergoing the LEEP. All participants were excised in one piece of LEEP. No top-hat excision in this study.  The patients graded their pain on a 10-cm visual analog scale (VAS) at different points during the procedure, including speculum insertion, at starting excision, and 30 minutes post excision. Primary outcomes revealed the difference of VAS during all steps of LEEP by generalized estimating equations procedure. RESULTS Sixty participants (30 in mefenamic group and 30 in placebo group) participated in this study. The study did not find differences of VAS during all steps of LEEP and analgesic drug requirement at 30 minutes after LEEP procedure. All patients reported no immediate complications and no intervention-related adverse events were observed. CONCLUSION Using pre-procedural oral mefenamic acid before LEEP procedure was not associated with pain reduction during all steps of excision.
.",2020,"CONCLUSION Using pre-procedural oral mefenamic acid before LEEP procedure was not associated with pain reduction during all steps of excision.
.","['Pain Control during Loop Electrical Excision Procedure', 'women undergoing Loop Electrosurgical Excision Procedure (LEEP) with intracervical lidocaine injection', 'Sixty participants (30 in mefenamic group and 30 in placebo group) participated in this study']","['Mefenamic Acid', 'oral placebo', 'placebo', 'immediate 10 mL of 2% lidocaine', 'epinephrine intracervical injection before undergoing the LEEP', 'mefenamic acid', 'LEEP', 'oral mefenamic acid']","['difference of VAS', 'pain reduction', 'adverse events', '10-cm visual analog scale (VAS']","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184930', 'cui_str': 'Loop electrosurgical excision procedure'}, {'cui': 'C0444978', 'cui_str': 'Intracervical'}, {'cui': 'C4049857', 'cui_str': 'Lidocaine Injection'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0025152', 'cui_str': 'mefenamic acid'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0444978', 'cui_str': 'Intracervical'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0184930', 'cui_str': 'Loop electrosurgical excision procedure'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.482376,"CONCLUSION Using pre-procedural oral mefenamic acid before LEEP procedure was not associated with pain reduction during all steps of excision.
.","[{'ForeName': 'Poochit', 'Initials': 'P', 'LastName': 'Dabpookhiew', 'Affiliation': 'Department of Obstetrics & Gynecology, Faculty of Medicine, Khon Kaen University, Thailand.'}, {'ForeName': 'Amornrat', 'Initials': 'A', 'LastName': 'Temtanakitpaisan', 'Affiliation': 'Department of Obstetrics & Gynecology, Faculty of Medicine, Khon Kaen University, Thailand.'}, {'ForeName': 'Chumnan', 'Initials': 'C', 'LastName': 'Kietpeerakool', 'Affiliation': 'Department of Obstetrics & Gynecology, Faculty of Medicine, Khon Kaen University, Thailand.'}, {'ForeName': 'Bandit', 'Initials': 'B', 'LastName': 'Chumworathayi', 'Affiliation': 'Department of Obstetrics & Gynecology, Faculty of Medicine, Khon Kaen University, Thailand.'}, {'ForeName': 'Apiwat', 'Initials': 'A', 'LastName': 'Aue-Aungkul', 'Affiliation': 'Department of Obstetrics & Gynecology, Faculty of Medicine, Khon Kaen University, Thailand.'}, {'ForeName': 'Fa-Ngam', 'Initials': 'FN', 'LastName': 'Chareonpol', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Khon Kaen University, Thailand.'}, {'ForeName': 'Nampet', 'Initials': 'N', 'LastName': 'Jampathong', 'Affiliation': 'Department of Obstetrics & Gynecology, Faculty of Medicine, Khon Kaen University, Thailand.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2020.21.12.3633'] 1775,33369459,Airway Blocks Vs LA Nebulization- An interventional trial for Awake Fiberoptic Bronchoscope assisted Nasotracheal Intubation in Oral Malignancies.,"BACKGROUND Patients with intra-oral malignancies warrants use of awake Fiberoptic assisted naso-thracheal intubation to secure an airway due to multiple risk factors leading to anticipated difficult airway. Different techniques such as airway blocks, local anesthesia (LA) gargles, spray, nebulization and  mild  sedation are in practice to improve  the success rate of fiberoptic assisted intubation. METHODS Sixty patients  of  ASA I and II with Mallampatti score 3 and above, posted for Commando operations were enrolled in this study and were divided into 2 groups. Group AB (Airway Block, n=30) were given Superior laryngeal nerve block bilaterally and recurrent laryngeal nerve block  transtracheally  with Inj  2% Lignocaine. Second Group AN (Airway Nebulization, n=30)  patients airway was nebulized with 4% Lignocaine  with ultrasonic nebulizer. After confirmation of satisfactory anesthesia clinically Fiber-optic assisted naso-tracheal intubation was attempted. Hemodynamic monitoring, total time taken for intubation, patients comfort and any complications occurred were noted. Statistical Analysis- All the observed values were tabulated and analyzed using software SPSS version 17.0. RESULTS Demography and Hemodynamic observations were comparable in the groups.  The time taken for intubation, patient comfort score, intubation conditions were excellent in AB group than in group AN. Airway complications like laryngospasm and cough were noted in AN Group. CONCLUSIONS Judicial use of combined Airway blocks such as Bilateral Superior and trans-tracheal recurrent laryngeal nerve blocks could facilitate a successful fiber-optic assisted awake naso-tracheal intubation in anticipated difficult intubation with negligible complications.
.",2020,"The time taken for intubation, patient comfort score, intubation conditions were excellent in AB group than in group AN.","['Sixty patients\xa0 of\xa0 ASA I and II with Mallampatti score 3 and above, posted for Commando operations', 'Patients with intra-oral malignancies', 'Oral Malignancies']","['awake Fiberoptic assisted naso-thracheal intubation', 'satisfactory anesthesia clinically Fiber-optic assisted naso-tracheal intubation', 'Superior laryngeal nerve block bilaterally and recurrent laryngeal nerve block\xa0 transtracheally\xa0 with Inj\xa0 2% Lignocaine', 'Lignocaine\xa0 with ultrasonic nebulizer', 'Awake Fiberoptic Bronchoscope assisted Nasotracheal Intubation', 'Airway Blocks Vs LA Nebulization']","['Airway complications like laryngospasm and cough', 'Demography and Hemodynamic observations', 'time taken for intubation, patient comfort score, intubation conditions', 'Hemodynamic monitoring, total time taken for intubation, patients comfort and any complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0074744', 'cui_str': 'sodium metabisulfite'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0015979', 'cui_str': 'Fiber Optic Technology'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0394817', 'cui_str': 'Local anesthetic superior laryngeal nerve block'}, {'cui': 'C0394818', 'cui_str': 'Local anesthetic recurrent laryngeal nerve block'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0027524', 'cui_str': 'Nebulizer'}, {'cui': 'C0179433', 'cui_str': 'Flexible bronchoscope'}, {'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}]","[{'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0023066', 'cui_str': 'Laryngeal spasm'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4082936', 'cui_str': 'Hemodynamic monitoring'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",30.0,0.0233837,"The time taken for intubation, patient comfort score, intubation conditions were excellent in AB group than in group AN.","[{'ForeName': 'Gajanan', 'Initials': 'G', 'LastName': 'Chavan', 'Affiliation': 'Department of Emergency Medicine, Jawaharlal Nehru Medical College, Sawangi (Meghe), Wardha, India.'}, {'ForeName': 'Aparna Upadhye', 'Initials': 'AU', 'LastName': 'Chavan', 'Affiliation': 'Jawaharlal Nehru Medical College, Sawangi (Meghe), Wardha, India.'}, {'ForeName': 'Shraddha', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Department of Oral Medicine and Radiology, Sharad Pawar Dental College, Sawangi (Meghe), Wardha, India.'}, {'ForeName': 'Vaibhav', 'Initials': 'V', 'LastName': 'Anjankar', 'Affiliation': 'Department of Anatomy, Jawaharlal Nehru Medical College, Sawangi (Meghe), Wardha, India.'}, {'ForeName': 'Prafulla', 'Initials': 'P', 'LastName': 'Gaikwad', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, Sharad Pawar Dental College, Sawangi (Meghe), Wardha, India.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2020.21.12.3613'] 1776,33373541,Preventing Enamel Caries Using Carbon Dioxide Laser and Silver Diamine Fluoride.,"Objective: This study was intended to investigate the caries prevention potential of carbon dioxide (CO 2 ) laser ( λ  = 10,600 nm) irradiation followed by application of silver diamine fluoride (SDF) to enamel. Materials and methods: Human enamel specimens were randomly allocated to four groups ( n  = 10 per group). Group 1 specimens were treated with SDF; Group 2 specimens were treated with a CO 2 laser; Group 3 specimens were irradiated with a CO 2 laser then treated with SDF, and Group 4 specimens received no treatment. All specimens were subjected to pH cycling for cariogenic challenge. Lesion depth, microhardness, surface morphology, and elemental analysis were assessed. Results: The lesion depths for Groups 1-4 were 33 ± 16, 80 ± 9, 18 ± 15, and 102 ± 9 μm, respectively ( p  < 0.001; Group 3 < Group 1 < Group 2 < Group 4). Knoop hardness values for Groups 1-4 were 61 ± 19, 68 ± 20, 78 ± 27, and 36 ± 8, respectively ( p  = 0.002; Group 4 < Groups 1, 2, and 3). The enamel in Group 4 but not in the other groups showed a roughened surface resembling an acid-etched pattern. Calcium-to-phosphorus molar ratios of Groups 1-4 were 1.68 ± 60.09, 1.61 ± 0.06, 1.69 ± 0.10, and 1.49 ± 0.10, respectively ( p  < 0.001; Group 4 < Groups 1, 2, and 3). Conclusions: Using the CO 2 laser or SDF separately enhanced the resistance of enamel to cariogenic challenge. Moreover, there was an additional effect of the combined use of the CO 2 laser and SDF for preventing enamel demineralization.",2021,The enamel in Group 4 but not in the other groups showed a roughened surface resembling an acid-etched pattern.,['Human enamel specimens'],"['SDF', 'CO 2 laser; Group 3 specimens were irradiated with a CO 2 laser then treated with SDF', 'carbon dioxide (CO 2 ) laser ( λ \u2009=\u200910,600\u2009nm) irradiation followed by application of silver diamine fluoride (SDF', 'Carbon Dioxide Laser and Silver Diamine Fluoride']","['lesion depths', 'Knoop hardness values', 'Calcium-to-phosphorus molar ratios', 'Lesion depth, microhardness, surface morphology, and elemental analysis']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1277077', 'cui_str': 'Irradiated blood product'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0074538', 'cui_str': 'Silver diamine fluoride'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",,0.0190704,The enamel in Group 4 but not in the other groups showed a roughened surface resembling an acid-etched pattern.,"[{'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Luk', 'Affiliation': 'School of Dentistry, Shenzhen University Health Science Center, Shenzhen, China.'}, {'ForeName': 'John Yun', 'Initials': 'JY', 'LastName': 'Niu', 'Affiliation': 'Shenzhen Institute of Research and Innovation, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Gutknecht', 'Affiliation': 'Department of Operative Dentistry, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Irene Shuping', 'Initials': 'IS', 'LastName': 'Zhao', 'Affiliation': 'School of Dentistry, Shenzhen University Health Science Center, Shenzhen, China.'}, {'ForeName': 'Chun Hung', 'Initials': 'CH', 'LastName': 'Chu', 'Affiliation': 'Shenzhen Institute of Research and Innovation, The University of Hong Kong, Hong Kong, China.'}]","Photobiomodulation, photomedicine, and laser surgery",['10.1089/photob.2020.4894'] 1777,33385511,"Medicinal seeds Ziziphus spinosa for insomnia: A randomized, placebo-controlled, cross-over, feasibility clinical trial.","OBJECTIVES To evaluate the feasibility of implementing a clinical trial protocol of the herbal seeds Ziziphus spinosa (ZS) for people with insomnia. DESIGN AND SETTING A randomized, double-blind, placebo controlled, cross-over feasibility trial in Melbourne, Australia. INTERVENTIONS After two-week run-in participants were randomized to either ZS (encapsulated granules; 2 g daily) or placebo for four weeks. After four-weeks wash-out, participants swapped to the other treatment for four weeks. MAIN OUTCOME MEASURES Sleep quality assessed by the Insomnia Severity Index and Pittsburgh Sleep Quality Index (PSQI). Quality of life, mood, functional impairment and sleep parameters were also assessed. RESULTS Twelve participants were randomized and completed both periods of cross-over (six in each sequence). Feasibility endpoints were acceptable. Improvements for sleep quality measured on the PSQI were statistically significant during the ZS treatment periods compared to placebo (t = -2.276, df = 10, 95 % CI -3.3 to -0.04, p = 0.046). There was no evidence of any significant carryover effects. However, there were period effects. Other outcomes showed no statistically significant difference between the treatments. Subjective sleep parameters measured on sleep diaries showed improvements after ZS in terms of total sleep time, sleep efficiency and sleep onset latency, but not after placebo. ZS was well tolerated with only minor adverse events. CONCLUSIONS ZS is an acceptable and well-tolerated herbal candidate for the treatment of insomnia. The feasibility objectives of this study were achieved and ZS improved both subjective sleep quality and quantity compared to placebo. ZS should be explored in future clinical trials.",2021,"Subjective sleep parameters measured on sleep diaries showed improvements after ZS in terms of total sleep time, sleep efficiency and sleep onset latency, but not after placebo.","['Medicinal seeds Ziziphus spinosa for insomnia', 'people with insomnia']","['ZS (encapsulated granules; 2\u2009g daily) or placebo', 'herbal seeds Ziziphus spinosa (ZS', 'placebo']","['Subjective sleep parameters', 'sleep quality', 'total sleep time, sleep efficiency and sleep onset latency', 'Quality of life, mood, functional impairment and sleep parameters', 'Sleep quality assessed by the Insomnia Severity Index and Pittsburgh Sleep Quality Index (PSQI', 'subjective sleep quality and quantity']","[{'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C1029148', 'cui_str': 'Zizyphus'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1029148', 'cui_str': 'Zizyphus'}, {'cui': 'C0205223', 'cui_str': 'Encapsulated'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}]",12.0,0.474806,"Subjective sleep parameters measured on sleep diaries showed improvements after ZS in terms of total sleep time, sleep efficiency and sleep onset latency, but not after placebo.","[{'ForeName': 'Johannah L', 'Initials': 'JL', 'LastName': 'Shergis', 'Affiliation': 'School of Health and Biomedical Sciences, RMIT University, PO BOX 71, Bundoora, Victoria 3083, Australia. Electronic address: johannah.shergis@rmit.edu.au.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hyde', 'Affiliation': 'School of Health and Biomedical Sciences, RMIT University, PO BOX 71, Bundoora, Victoria 3083, Australia. Electronic address: anna.hyde@rmit.edu.au.'}, {'ForeName': 'Hailey', 'Initials': 'H', 'LastName': 'Meaklim', 'Affiliation': 'School of Health and Biomedical Sciences, RMIT University, PO BOX 71, Bundoora, Victoria 3083, Australia. Electronic address: hailey.meaklim@rmit.edu.au.'}, {'ForeName': 'Prerna', 'Initials': 'P', 'LastName': 'Varma', 'Affiliation': 'School of Health and Biomedical Sciences, RMIT University, PO BOX 71, Bundoora, Victoria 3083, Australia. Electronic address: prerna.varma@rmit.edu.au.'}, {'ForeName': 'Cliff', 'Initials': 'C', 'LastName': 'Da Costa', 'Affiliation': 'School of Science, RMIT University, PO BOX 71, Bundoora, Victoria 3083, Australia. Electronic address: cliff.dacosta@rmit.edu.au.'}, {'ForeName': 'Melinda L', 'Initials': 'ML', 'LastName': 'Jackson', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Victoria 3800, Australia. Electronic address: melinda.jackson@monash.edu.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102657'] 1778,33388390,A qualitative study on participants' experiences with a community-based mindful walking intervention and mobile device activity measurement.,"BACKGROUND Mindful walking (MW) interventions employ mindfulness training combined with physical activity. Wearable mobile devices have been increasingly used to measure outcomes of physical activity interventions. The purpose of this study was to understand MW participants' attitudes towards MW and the use of mobile devices in health promotion interventions, including barriers and facilitators of intervention engagement and adherence. Few qualitative studies have documented participant experience with these two types of interventions. METHOD The pilot study involved a randomized MW intervention including 38 participants with self-reported inadequate physical activity. Half of them were randomized to receive MW intervention plus a FitBit device and the other received the FitBit device only. We used a qualitative thematic analysis of the narrative data collected through open-ended survey questions at three time points. Participants in the MW intervention were asked to describe their experiences with MW, while all participants were asked to describe their experience with wearing the FitBit to track their step counts. RESULTS Participants reported a broad range of perceived benefits and challenges related to adopting the MW intervention and using the mobile device. Participants were generally willing to try to adopt the recommended MW practice and to see value of MW in increasing physical activity and improving overall health. Participants reported using a variety of additional device features beyond goal setting and step counts, indicating using the devices may have been effective in providing additional motivation for participants in meeting physical activity goals in both the control and intervention groups. While most of the feedback about MW (in the intervention group) and the device (all participants) was overwhelmingly positive, a minority of participants reported barriers such as lack of patience with meditation and discomfort with wearing the device. CONCLUSION Most participants in the MW intervention see the health benefits of this program and most participants using the wearable physical activity tracking device reported the motivational benefits of this device. Issues with the MW intervention (e.g., lack of patience) and the wearable device (e.g., discomfort with wearing) need to be addressed in future interventions.",2021,Most participants in the MW intervention see the health benefits of this program and most participants using the wearable physical activity tracking device reported the motivational benefits of this device.,"['38 participants with self-reported inadequate physical activity', ""participants' experiences with a"", ""MW participants' attitudes towards MW""]","['MW intervention', 'Mindful walking ', 'community-based mindful walking intervention and mobile device activity measurement', 'MW intervention plus a FitBit device']",['health benefits'],"[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0086387', 'cui_str': 'Health Benefits'}]",38.0,0.0725935,Most participants in the MW intervention see the health benefits of this program and most participants using the wearable physical activity tracking device reported the motivational benefits of this device.,"[{'ForeName': 'Karyn O', 'Initials': 'KO', 'LastName': 'Jones', 'Affiliation': 'School of Nursing, Clemson University, USA. Electronic address: karynj@clemson.edu.'}, {'ForeName': 'Snehal S', 'Initials': 'SS', 'LastName': 'Lopes', 'Affiliation': 'Department of Public Health Sciences, Clemson University, USA.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Kelly', 'Affiliation': 'Department of Public Health Sciences, Clemson University, USA.'}, {'ForeName': 'Ralph S', 'Initials': 'RS', 'LastName': 'Welsh', 'Affiliation': 'Department of Public Health Sciences, Clemson University, USA.'}, {'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology, Fielding School of Public Health, University of California Los Angeles, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wilson', 'Affiliation': 'Department of Public Health Sciences, Clemson University, USA.'}, {'ForeName': 'Meenu', 'Initials': 'M', 'LastName': 'Jindal', 'Affiliation': 'Internal Medicine Clinic, Prisma Health System, USA; Department of Medicine, School of Medicine Greenville, University of South Carolina, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Zinzow', 'Affiliation': 'Department of Psychology, Clemson University, USA.'}, {'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Nursing, College of Nursing and Health Sciences, University of Massachusetts Boston, USA.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Department of Public Health Sciences, Clemson University, USA.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102640'] 1779,33389399,CTCs-oriented adjuvant personalized cytostatic therapy non-metastatic breast cancer patients: continuous non-randomized prospective study and prospective randomized controlled study.,"THE AIM To conduct a prospective randomized controlled study of the optimization of adjuvant therapy in patients with non-metastatic breast cancer, taking into account the presence of circulating tumor cells (CTCs) with an assessment of tumor-specific OS and DFS. MATERIALS Stage 1 Continuous non-randomized prospective study (n = 102) to study the clinical and prognostic value of CTCs and evaluate the effectiveness of adjuvant systemic therapy in relation to CTC eradication; Stage 2 Prospective randomized controlled study (n = 128) of optimization of adjuvant therapy taking into account CTCs with an assessment of the effectiveness of the standard therapy and an optimized therapy regimen. RESULTS Monitoring of CTCs during adjuvant drug treatment has established that a significant decrease in the frequency of CTC identification can be achieved only by sequential administration of anthracyclines and taxanes (paclitaxel) AC-T, which allows reducing CTCs compared to other regimens from 52.6 to 15.8% (p = 0.006). CTC-oriented personalized adjuvant therapy in the experimental group, based on the timely transition from an ineffective adjuvant chemotherapy regimen to taxanes, as well as additional monochemotherapy with gemcitabine can achieve 100% eradication CTCs. In the adjuvant therapy experimental group taking into account CTCs (n = 68), the OS 5-year tumor-specific rate was 90.3 ± 3.8%, (control group 78.7 ± 3.9%, p = 0.036). DFS tumor-specific in the experimental group was 88.0 ± 4.4%, (control group 80.6 ± 3.3%, p = 0.023). CONCLUSIONS The use of the method of treatment of CTC-oriented personalized adjuvant therapy for non-metastatic breast cancer makes it possible to reliably increase DFS 5-year by 7.4% and OS 5-year by 11.6%.",2021,"In the adjuvant therapy experimental group taking into account CTCs (n = 68), the OS 5-year tumor-specific rate was 90.3 ± 3.8%, (control group 78.7 ± 3.9%, p = 0.036).","['patients with non-metastatic breast cancer', 'non-metastatic breast cancer patients']","['adjuvant systemic therapy', 'gemcitabine', 'CTCs-oriented adjuvant personalized cytostatic therapy', 'adjuvant therapy', 'CTC-oriented personalized adjuvant therapy', 'anthracyclines and taxanes (paclitaxel) AC-T']","['OS 5-year tumor-specific rate', 'frequency of CTC identification', 'DFS tumor-specific', 'DFS 5-year']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0010858', 'cui_str': 'Cytostatics'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0215136', 'cui_str': 'taxane'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}]",,0.0141276,"In the adjuvant therapy experimental group taking into account CTCs (n = 68), the OS 5-year tumor-specific rate was 90.3 ± 3.8%, (control group 78.7 ± 3.9%, p = 0.036).","[{'ForeName': 'Ya A', 'Initials': 'YA', 'LastName': 'Shliakhtunou', 'Affiliation': 'Department of Oncology, Educational Establishment ""Vitebsk State Medical University"", Frunze Av., 27, 210009, Vitebsk, Republic of Belarus. Evgenij-shlyakhtunov@yandex.ru.'}]",Breast cancer research and treatment,['10.1007/s10549-020-06036-z'] 1780,33400330,"Long-term efficacy and safety of erenumab in migraine prevention: Results from a 5-year, open-label treatment phase of a randomized clinical trial.","BACKGROUND AND PURPOSE Although erenumab has demonstrated significant reduction in migraine frequency and improved quality of life in studies lasting 3 to 12 months, little is known about long-term therapy. METHODS This study was an open-label, 5-year treatment phase following a 12-week, double-blind, placebo-controlled trial in adults with episodic migraine. Patients initially received open-label erenumab 70 mg, which increased to 140 mg following a protocol amendment. Efficacy analyses included change from baseline in monthly migraine days (MMDs), monthly acute migraine-specific medication (AMSM) days, and health-related quality of life. RESULTS Of 383 patients enrolled, 250 switched to 140 mg; 215 (56.1%) completed open-label treatment. Mean (standard error) change in MMDs from baseline of 8.7 (0.2) days was -5.3 (0.3) days; an average reduction of 62.3% at year 5. Among patients using AMSM at baseline (6.3 [2.8] treatment days), mean change in monthly AMSM days was -4.4 (0.3) days at the end of 5 years. Patient-reported outcomes indicated stable improvements in disability, headache impact, and migraine-specific quality of life. Exposure-adjusted patient incidence rates of adverse events (AEs) were 123.0/100 patient-years; AEs were most frequently nasopharyngitis, upper respiratory tract infection, and influenza. Serious AEs (SAEs) reported by 49 patients (3.8/100 patient-years) were mostly single occurrence. Two fatal adverse events were reported. There were no increases in incidence of AEs, SAEs, or AEs leading to treatment discontinuation over 5 years of exposure. CONCLUSIONS Treatment with erenumab was associated with reductions in migraine frequency and improvements in health-related quality of life that were maintained for at least 5 years. No new safety signals were observed.",2021,"There were no increases in incidence of AEs, SAEs, or AEs leading to treatment discontinuation over 5 years of exposure. ","['383 patients enrolled, 250 switched to 140 mg; 215 (56.1%) completed open-label treatment', 'adults with episodic migraine']","['erenumab', 'placebo']","['monthly migraine days (MMD), monthly acute migraine-specific medication (AMSM) days, and health-related quality of life', 'incidence of AEs, SAEs, or AEs leading to treatment discontinuation', 'migraine frequency and improvements in health-related quality of life', 'migraine frequency and improved quality of life', 'Mean (SE) change in MMD', 'disability, headache impact, and migraine-specific quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}]","[{'cui': 'C4542165', 'cui_str': 'erenumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1740836', 'cui_str': 'Acute migraine'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]",383.0,0.0697799,"There were no increases in incidence of AEs, SAEs, or AEs leading to treatment discontinuation over 5 years of exposure. ","[{'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Department of Neurology, Danish Headache Center, Faculty of Health and Medical Sciences, Rigshospitalet Glostrup, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""NIHR/Wellcome Trust King's Clinical Research Facility, King's College London, London, UK.""}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Reuter', 'Affiliation': 'Department of Neurology, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Silberstein', 'Affiliation': 'Jefferson Headache Center, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': 'Department of Neurology, Mayo Clinic, Scottsdale, AZ, USA.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xue', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Paiva da Silva Lima', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Sunfa', 'Initials': 'S', 'LastName': 'Cheng', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Mikol', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}]",European journal of neurology,['10.1111/ene.14715'] 1781,33399223,"Associations Between Trauma, Sleep, and Cognitive Impairment Among Latino and Asian Older Adults.","BACKGROUND/OBJECTIVES Trauma survivors with chronic post-traumatic stress disorder (PTSD) have been found to have cognitive impairment. But little is known about these outcomes among Latino and Asians who comprise more than 80% of the U.S. immigrant population. They also experience disparities in PTSD and dementia care albeit increased exposure to trauma. This study aimed to (1) examine the association between trauma exposures and PTSD with cognitive impairment in a sample of Latino and Asian older adults; and (2) assess whether sleep quality attenuated the PTSD-cognitive impairment association. DESIGN Cross-sectional secondary analysis of baseline data from the Positive Minds-Strong Bodies randomized controlled trial on disability prevention. SETTING Community-based organizations serving minority or immigrant older adults in Massachusetts, New York, Florida, or Puerto Rico. PARTICIPANTS Hispanic/Latino and Asian/Pacific Islander adults aged 60 or older eligible per randomized controlled trial screening for elevated mood symptoms and minor-to-moderate physical dysfunction (n = 134 and n = 86, respectively). MEASUREMENTS Neuropsychiatric measures were cognitive impairment (Mini Montreal Cognitive Assessment (MoCA)), PTSD (Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual-5), trauma exposure (Brief Trauma Questionnaire), depression (Patient Health Questionnaire-9), generalized anxiety (Generalized Anxiety Disorder Scale-7), and daytime sleepiness (Epworth Sleepiness Scale). RESULTS Mean age was 72.8 years and 77.5 years for the Latino and Asian groups, respectively. The Asian group was 100% immigrant, whereas 70.2% (n = 92) of the Latino group was foreign-born. In unadjusted models, higher Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual-5 scores were associated with decreased odds of normal cognitive functioning (MoCA ≥25) in the Asian group (odds ratio (95% confidence interval) = .93 (.87, .99)), but not the Latino group (odds ratio (95% confidence interval) = .99 (.95, 1.05)). This association remained significant after adjusting for covariates. Daytime sleepiness did not moderate the association between PTSD and cognitive functioning in the Asian group. CONCLUSION Higher PTSD symptoms were associated with cognitive impairment in Asian, but not Latino, older adults. Clinicians serving older Asians should integrate trauma and cognitive screening to ensure this growing, underserved population receives appropriate evidence-based treatments.",2021,"The Asian group was 100% immigrant, whereas 70.2% (n = 92) of the Latino group was foreign-born.","['Mean age was 72.8\u2009years and 77.5\u2009years for the Latino and Asian groups, respectively', 'Trauma survivors with chronic post-traumatic stress disorder (PTSD', 'Community-based organizations serving minority or immigrant older adults in Massachusetts, New York, Florida, or Puerto Rico', 'sample of Latino and Asian older adults', 'Latino and Asian Older Adults', 'Hispanic/Latino and Asian/Pacific Islander adults aged 60 or older eligible per randomized controlled trial screening for elevated mood symptoms and minor-to-moderate physical dysfunction (n = 134 and n = 86, respectively']",[],"['cognitive impairment (Mini Montreal Cognitive Assessment (MoCA)), PTSD (Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual-5), trauma exposure (Brief Trauma Questionnaire), depression (Patient Health Questionnaire-9), generalized anxiety (Generalized Anxiety Disorder Scale-7), and daytime sleepiness (Epworth Sleepiness Scale', 'Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual-5 scores', 'normal cognitive functioning', 'Trauma, Sleep, and Cognitive Impairment', 'Daytime sleepiness']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0730525', 'cui_str': 'Chronic post-traumatic stress disorder'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0282163', 'cui_str': 'Immigrant'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0016253', 'cui_str': 'Florida'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0242191', 'cui_str': 'Pacific Island Americans'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0233479', 'cui_str': 'Elevated mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C4517565', 'cui_str': '134'}]",[],"[{'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]",,0.0376978,"The Asian group was 100% immigrant, whereas 70.2% (n = 92) of the Latino group was foreign-born.","[{'ForeName': 'Altaf', 'Initials': 'A', 'LastName': 'Saadi', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Cruz-Gonzalez', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hwang', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Cohen', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Alegria', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16986'] 1782,33399175,Efficacy of manual therapy on psychological status and pain in patients with neck pain. A randomized clinical trial.,"OBJECTIVES To compare the effectiveness of Maitland versus Mulligan mobilization techniques on pain, functional disability, and psychological status in patients with neck pain. METHODS Forty-four patients with nonspecific neck pain were randomly assigned to the Maitland group (n=22 patients received Maitland therapy [central or unilateral postero-anterior pressure] for 2 sessions/week for 3 weeks) and Mulligan group (n=22 patients received Mulligan sustained natural apophyseal glides for 2 sessions/week for 3 weeks).  This study was conducted at the Rehabilitation Clinic, King Abdulaziz Hospital, Jeddah, Kingdom of Saudi Arabia between December 2016 to May 2017. The outcome measures were the numeric pain rating scale score, neck disability index score, beck depression inventory score, State-trait anxiety inventory score, fear avoidance beliefs questionnaire, and pain catastrophic scale results. The independent t-test, Shapiro-Wilk test, and paired t-test were used in data analysis. RESULTS There were significant improvements in mean values of the numeric pain rating scale, neck disability index, beck depression inventory, state-trait anxiety inventory scores, and pain catastrophic scale results after the interventions in both groups (p less than 0.05, all except fear avoidance beliefs results in mulligan group p greater than 0.05), and there were no significant differences in mean values between the groups (p greater than 0.05).  Conclusion. In patients with nonspecific neck pain, Maitland and Mulligan mobilization techniques have positive effects on neck pain, functional disability, and selected psychological features with no significant difference between them.",2021,"There were significant improvements in mean values of the numeric pain rating scale, neck disability index, beck depression inventory, state-trait anxiety inventory scores, and pain catastrophic scale results after the interventions in both groups (p less than 0.05, all except fear avoidance beliefs results in mulligan group p greater than 0.05), and there were no significant differences in mean values between the groups (p greater than 0.05).  ","['Forty-four patients with nonspecific neck pain were randomly assigned to the Maitland group (n=22 patients received', 'patients with neck pain', 'Rehabilitation Clinic, King Abdulaziz Hospital, Jeddah, Kingdom of Saudi Arabia between December 2016 to May 2017']","['Mulligan group', 'Maitland therapy [central or unilateral postero-anterior pressure', 'Mulligan sustained natural apophyseal glides', 'manual therapy', 'Maitland versus Mulligan mobilization techniques']","['mean values of the numeric pain rating scale, neck disability index, beck depression inventory, state-trait anxiety inventory scores, and pain catastrophic scale results', 'pain, functional disability, and psychological status', 'mean values', 'numeric pain rating scale score, neck disability index score, beck depression inventory score, State-trait anxiety\xa0inventory score, fear avoidance beliefs questionnaire, and pain catastrophic scale results', 'psychological status and pain', 'neck pain, functional disability']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3839785', 'cui_str': 'Rehabilitation clinic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0336966', 'cui_str': 'Gliding'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C2959538', 'cui_str': 'Neck disability index score'}, {'cui': 'C2960571', 'cui_str': 'Beck depression inventory score'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}]",44.0,0.056623,"There were significant improvements in mean values of the numeric pain rating scale, neck disability index, beck depression inventory, state-trait anxiety inventory scores, and pain catastrophic scale results after the interventions in both groups (p less than 0.05, all except fear avoidance beliefs results in mulligan group p greater than 0.05), and there were no significant differences in mean values between the groups (p greater than 0.05).  ","[{'ForeName': 'Samar M', 'Initials': 'SM', 'LastName': 'Alansari', 'Affiliation': 'Department of Physical Therapy, King Abdulaziz Hospital, Jeddah, Kingdom of Saudi Arabia. E-mail. samar_alansari@hotmail.com.'}, {'ForeName': 'Enas F', 'Initials': 'EF', 'LastName': 'Youssef', 'Affiliation': ''}, {'ForeName': 'Alsayed A', 'Initials': 'AA', 'LastName': 'Shanb', 'Affiliation': ''}]",Saudi medical journal,['10.15537/smj.2021.1.25589'] 1783,33399174,Cardiopulmonary resuscitation is more effective for in-hospital cardiac arrest when performed on a stretcher. A manikin study.,"OBJECTIVES To compare the efficacies of various chest compression procedures performed on a stretcher during dynamic transport of patients with in-hospital cardiac arrest. Methods: This prospective and randomized cross-over study used manikins. Practitioners were asked to perform chest compressions on a manikin placed on a moving stretcher for 2 minutes. Cardiopulmonary resuscitation (CPR)  procedures were included the following 3 types: i) CPR-walking (CPR-W) ii) CPR-straddling (CPR-S), and iii) CPR-mechanical chest compression device (CPR-MCCD). Demographic data of the participants, CPR quality indicators, the time between the start command and first compression, level of difficulty, and the distance covered by the stretcher for the duration of each application were recorded. RESULTS Thirty-two physicians (9 female, 23 male), participated in this study. The CPR-MCCD procedure was the most effective for all parameters, except the time between the start command and first compression. On the other hand, the compression rate at optimal depth, CPR success score, distance covered, and level of difficulty parameters were significantly favored in the CPR-S group, when compared to the CPR-W group (p less than 0.001, all comparisons). CONCLUSIONS It is possible to perform high-quality chest compressions during patient transport using the CPR-MCCD method. The CPR-S method allowed practitioners to perform higher-quality chest compressions compared to CPR-W.",2021,"The CPR-MCCD procedure was the most effective for all parameters, except the time between the start command and first compression.","['Thirty-two physicians (9 female, 23 male', 'patients with in-hospital cardiac arrest']","['Cardiopulmonary resuscitation', 'CPR-walking (CPR-W) ii) CPR-straddling (CPR-S), and iii) CPR-mechanical chest compression device (CPR-MCCD', 'various chest compression procedures']","['compression rate at optimal depth, CPR success score, distance covered, and level of difficulty parameters', 'CPR quality indicators, the time between the start command and first compression, level of difficulty']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0625319', 'cui_str': 'methylcyanocarbamate dimer'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]",,0.0126258,"The CPR-MCCD procedure was the most effective for all parameters, except the time between the start command and first compression.","[{'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Tezel', 'Affiliation': 'Department of Emergency Medicine, Gulhane School of Medicine, University of Health Sciences, Ankara, Turkey. E-mail. dr.onurtezel@gmail.com.'}, {'ForeName': 'Sedat', 'Initials': 'S', 'LastName': 'Bilge', 'Affiliation': ''}, {'ForeName': 'Gökhan', 'Initials': 'G', 'LastName': 'Özkan', 'Affiliation': ''}]",Saudi medical journal,['10.15537/smj.2021.1.25607'] 1784,33359269,Prostate high dose-rate brachytherapy as monotherapy for prostate cancer: Late toxicity and patient reported outcomes from a randomized phase II clinical trial.,"BACKGROUND AND PURPOSE Long-term toxicity of high dose-rate brachytherapy as monotherapy for prostate cancer is not well defined. We report late toxicity and health related quality of life (HRQOL) changes from a randomized phase II clinical trial of two different fractionation schemes. MATERIALS AND METHODS Eligible patients had NCCN low or intermediate risk prostate cancer. 170 patients were randomized to receive either a single 19 Gy or two-fractions of 13.5 Gy one week apart. Toxicity was measured using Common Terminology for Adverse Events (CTCAE) v4.0, and HRQOL was measured using the Expanded Prostate Index Composite (EPIC). RESULTS Median follow-up was 63 months. The 5-year cumulative incidence of Grade 2 or higher genitourinary (GU) and gastrointestinal (GI) toxicity was 62% and 12% in the single-fraction arm, and 47% and 9% in the two-fraction arm, respectively. Grade 3 GU toxicity was only seen in the single fraction arm with a cumulative incidence of 2%. The 5-year prevalence of Grade 2 GU toxicity was 29% and 21%, in the single- and two-fraction arms, respectively, with Grade 2 GI toxicity of 1% and 2%. Beyond the first year, no significant differences in mean urinary HRQOL were seen compared to baseline in the two-fraction arm, in contrast to the single-fraction arm where a decline in urinary HRQOL was seen at 4 and 5 years. Sexual HRQOL was significantly reduced in both treatment arms at all timepoints, with no changes in the bowel domain. CONCLUSIONS HDR monotherapy is well tolerated with minimal impact on HRQOL.",2021,"Beyond the first year, no significant differences in mean urinary HRQOL were seen compared to baseline in the two-fraction arm, in contrast to the single-fraction arm where a decline in urinary HRQOL was seen at 4 and 5 years.","['170 patients', 'prostate cancer', 'Eligible patients had NCCN low or intermediate risk prostate cancer']","['HDR monotherapy', 'Prostate high dose-rate brachytherapy']","['late toxicity and health related quality of life (HRQOL) changes', 'Toxicity', 'HRQOL', '5-year prevalence of Grade 2 GU toxicity', 'mean urinary HRQOL', '5-year cumulative incidence of Grade 2 or higher genitourinary (GU) and gastrointestinal (GI) toxicity', 'GU toxicity', 'Grade 2 GI toxicity', 'urinary HRQOL', 'Sexual HRQOL']","[{'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C1158513', 'cui_str': 'Recombinational Repair of DNA'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0454270', 'cui_str': 'High dose rate brachytherapy'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}]",170.0,0.0997047,"Beyond the first year, no significant differences in mean urinary HRQOL were seen compared to baseline in the two-fraction arm, in contrast to the single-fraction arm where a decline in urinary HRQOL was seen at 4 and 5 years.","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Corkum', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Loblaw', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Yaser', 'Initials': 'Y', 'LastName': 'Hasan', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Hans T', 'Initials': 'HT', 'LastName': 'Chung', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Chia-Lin', 'Initials': 'CL', 'LastName': 'Tseng', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Merrylee', 'Initials': 'M', 'LastName': 'McGuffin', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Cheung', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Szumacher', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, Canada.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Chu', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Mamedov', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Morton', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, Canada. Electronic address: gerard.morton@sunnybrook.ca.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.12.021'] 1785,33369625,Effect of Motor Skill Training in Functional Activities vs Strength and Flexibility Exercise on Function in People With Chronic Low Back Pain: A Randomized Clinical Trial.,"Importance Chronic low back pain (LBP) is the most prevalent chronic pain in adults, and there is no optimal nonpharmacologic management. Exercise is recommended, but no specific exercise-based treatment has been found to be most effective. Objective To determine whether an exercise-based treatment of person-specific motor skill training (MST) in performance of functional activities is more effective in improving function than strength and flexibility exercise (SFE) immediately, 6 months, and 12 months following treatment. The effect of booster treatments 6 months following treatment also was examined. Design, Setting, and Participants In this single-blind, randomized clinical trial of people with chronic, nonspecific LBP with 12-month follow-up, recruitment spanned December 2013 to August 2016 (final follow-up, November 2017), and testing and treatment were performed at an academic medical center. Recruitment was conducted by way of flyers, physician and physical therapy offices, advertisements, and media interviews at Washington University in St Louis, Missouri. Of 1595 adults screened for eligibility, 1301 did not meet the inclusion criteria and 140 could not be scheduled for the first visit. A total of 154 people with at least 12 months of chronic, nonspecific LBP, aged 18 to 60 years, with modified Oswestry Disability Questionnaire (MODQ) score of at least 20% were randomized to either MST or SFE. Data were analyzed between December 1, 2017, and October 6, 2020. Interventions Participants received 6 weekly 1-hour sessions of MST in functional activity performance or SFE of the trunk and lower limbs. Half of the participants in each group received up to 3 booster treatments 6 months following treatment. Main Outcomes and Measures The primary outcome was the modified Oswestry Disability Questionnaire (MODQ) score (0%-100%) evaluated immediately, 6 months, and 12 months following treatment. Results A total of 149 participants (91 women; mean [SD] age, 42.5 [11.7] years) received some treatment and were included in the intention-to-treat analysis. Following treatment, MODQ scores were lower for MST than SFE by 7.9 (95% CI, 4.7 to 11.0; P < .001). During the follow-up phase, the MST group maintained lower MODQ scores than the SFE group, 5.6 lower at 6 months (95% CI, 2.1 to 9.1) and 5.7 lower at 12 months (95% CI, 2.2 to 9.1). Booster sessions did not change MODQ scores in either treatment. Conclusions and Relevance People with chronic LBP who received MST had greater short-term and long-term improvements in function than those who received SFE. Person-specific MST in functional activities limited owing to LBP should be considered in the treatment of people with chronic LBP. Trial Registration ClinicalTrials.gov Identifier: NCT02027623.",2021,"Following treatment, MODQ scores were lower for MST than SFE by 7.9 (95% CI, 4.7 to 11.0; P < .001).","['people with chronic LBP', '1595 adults screened for eligibility, 1301 did not meet the inclusion criteria and 140 could not be scheduled for the first visit', 'Importance\n\n\nChronic low back pain (LBP', 'people with chronic, nonspecific LBP with 12-month follow-up, recruitment spanned December 2013 to August 2016 (final follow-up, November 2017), and testing and treatment were performed at an academic medical center', '154 people with at least 12 months of chronic, nonspecific LBP, aged 18 to 60 years, with modified Oswestry Disability Questionnaire (MODQ) score of at least 20', '149 participants (91 women; mean [SD] age, 42.5 [11.7] years) received some treatment and were included in the intention-to-treat analysis', 'People With Chronic Low Back Pain']","['MST', 'exercise-based treatment of person-specific motor skill training (MST', 'SFE', 'Motor Skill Training in Functional Activities vs Strength and Flexibility Exercise', 'MST or SFE']","['modified Oswestry Disability Questionnaire (MODQ) score', 'MODQ scores', 'change MODQ scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517535', 'cui_str': '11.7'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",154.0,0.122254,"Following treatment, MODQ scores were lower for MST than SFE by 7.9 (95% CI, 4.7 to 11.0; P < .001).","[{'ForeName': 'Linda R', 'Initials': 'LR', 'LastName': 'van Dillen', 'Affiliation': 'Program in Physical Therapy, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Vanessa M', 'Initials': 'VM', 'LastName': 'Lanier', 'Affiliation': 'Program in Physical Therapy, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Steger-May', 'Affiliation': 'Division of Biostatistics, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wallendorf', 'Affiliation': 'Division of Biostatistics, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Norton', 'Affiliation': 'Program in Physical Therapy, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Jesse M', 'Initials': 'JM', 'LastName': 'Civello', 'Affiliation': 'Program in Physical Therapy, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Sylvia L', 'Initials': 'SL', 'LastName': 'Czuppon', 'Affiliation': 'Program in Physical Therapy, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Sara J', 'Initials': 'SJ', 'LastName': 'Francois', 'Affiliation': 'Program in Physical Therapy, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Roles', 'Affiliation': 'Program in Physical Therapy, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Lang', 'Affiliation': 'Program in Physical Therapy, Washington University School of Medicine in St Louis, St Louis, Missouri.'}]",JAMA neurology,['10.1001/jamaneurol.2020.4821'] 1786,33349011,Intravenous Hydrogen Therapy With Intracisternal Magnesium Sulfate Infusion in Severe Aneurysmal Subarachnoid Hemorrhage.,"BACKGROUND AND PURPOSE Poor-grade subarachnoid hemorrhage still has a poor prognosis. This randomized controlled clinical trial evaluated intracisternal magnesium sulfate infusion combined with intravenous hydrogen therapy in patients with poor-grade subarachnoid hemorrhage. METHODS Thirty-seven patients with poor-grade subarachnoid hemorrhage were randomized to Mg+H 2 , Mg, and control groups. Mg and Mg+H 2 groups received intracisternal magnesium sulfate infusion (2.5 mmol/L) at 20 mL/h for 14 days. Mg+H 2 group also received intravenous hydrogen-rich solution infusion for 14 days. Primary outcome measures were occurrence of delayed cerebral ischemia and cerebral vasospasm. Secondary outcome measures were modified Rankin Scale and Karnofsky performance status at 3 and 12 months, Barthel index at 12 months, and serum and cerebrospinal fluid malondialdehyde and neuron-specific enolase. RESULTS Serum neuron-specific enolase levels were significantly lower in the Mg+H 2 group from days 3 to 14 than in the control group. Cerebrospinal fluid neuron-specific enolase levels were also significantly lower in the Mg+H 2 group from days 3 to 7 than in the control group. Incidences of cerebral vasospasm and delayed cerebral ischemia were significantly higher in the control group than in other groups. Modified Rankin Scale and Karnofsky performance status did not significantly differ between the three groups at 3 months. Modified Rankin Scale scores 0 to 2 were more common in the Mg and Mg+H 2 groups at 1 year. Barthel index was higher in the Mg+H 2 group than in the control group. CONCLUSIONS Intracisternal magnesium sulfate infusion started immediately after surgery reduces the incidence of cerebral vasospasm and delayed cerebral ischemia and improves clinical outcomes without complications in patients with poor-grade subarachnoid hemorrhage. Intracisternal magnesium sulfate infusion combined with intravenous hydrogen therapy decreases serum malondialdehyde and neuron-specific enolase and improves Barthel index, indicating hydrogen has additional effects. Registration: URL: https://www.umin.ac.jp/ctr/index.htm. Unique identifier: UMIN000014696.",2021,Serum neuron-specific enolase levels were significantly lower in the Mg+H 2 group from days 3 to 14 than in the control group.,"['patients with poor-grade subarachnoid hemorrhage', 'Thirty-seven patients with poor-grade subarachnoid hemorrhage', 'Severe Aneurysmal Subarachnoid Hemorrhage']","['Intravenous Hydrogen Therapy With Intracisternal Magnesium Sulfate Infusion', 'intracisternal magnesium sulfate infusion', 'Intracisternal magnesium sulfate infusion combined with intravenous hydrogen therapy', 'Intracisternal magnesium sulfate', 'intravenous hydrogen-rich solution infusion', 'intracisternal magnesium sulfate infusion combined with intravenous hydrogen therapy', 'Mg+H']","['Serum neuron-specific enolase levels', 'Incidences of cerebral vasospasm and delayed cerebral ischemia', 'Modified Rankin Scale and Karnofsky performance status', 'occurrence of delayed cerebral ischemia and cerebral vasospasm', 'Modified Rankin Scale scores', 'modified Rankin Scale and Karnofsky performance status at 3 and 12 months, Barthel index at 12 months, and serum and cerebrospinal fluid malondialdehyde and neuron-specific enolase', 'Cerebrospinal fluid neuron-specific enolase levels', 'incidence of cerebral vasospasm and delayed cerebral ischemia', 'serum malondialdehyde and neuron-specific enolase and improves Barthel index', 'Barthel index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0038525', 'cui_str': 'Subarachnoid hemorrhage'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0751530', 'cui_str': 'Subarachnoid Hemorrhage, Aneurysmal'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1512924', 'cui_str': 'Intracisternal route'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202144', 'cui_str': 'Neuron-specific enolase measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0265110', 'cui_str': 'Spasm of cerebral arteries'}, {'cui': 'C4761225', 'cui_str': 'Delayed cerebral ischaemia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky performance status'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",37.0,0.0471706,Serum neuron-specific enolase levels were significantly lower in the Mg+H 2 group from days 3 to 14 than in the control group.,"[{'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Takeuchi', 'Affiliation': 'Department of Neurosurgery, National Defense Medical College, Saitama, Japan (S.T., K.K., T.T., N.O., K.W., K.M.).'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Kumagai', 'Affiliation': 'Department of Neurosurgery, National Defense Medical College, Saitama, Japan (S.T., K.K., T.T., N.O., K.W., K.M.).'}, {'ForeName': 'Terushige', 'Initials': 'T', 'LastName': 'Toyooka', 'Affiliation': 'Department of Neurosurgery, National Defense Medical College, Saitama, Japan (S.T., K.K., T.T., N.O., K.W., K.M.).'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Otani', 'Affiliation': 'Department of Neurosurgery, National Defense Medical College, Saitama, Japan (S.T., K.K., T.T., N.O., K.W., K.M.).'}, {'ForeName': 'Kojiro', 'Initials': 'K', 'LastName': 'Wada', 'Affiliation': 'Department of Neurosurgery, National Defense Medical College, Saitama, Japan (S.T., K.K., T.T., N.O., K.W., K.M.).'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Mori', 'Affiliation': 'Department of Neurosurgery, National Defense Medical College, Saitama, Japan (S.T., K.K., T.T., N.O., K.W., K.M.).'}]",Stroke,['10.1161/STROKEAHA.120.031260'] 1787,33370616,"A cluster-randomized controlled trial of an elementary school drinking water access and promotion intervention: Rationale, study design, and protocol.","INTRODUCTION Promoting water consumption among children in schools is a promising intervention to reduce sugar-sweetened beverage (SSB) intake and achieve healthful weight. To date, no studies in the United States have examined how a school-based water access and promotion intervention affects students' beverage and food intake both in and out of school and weight gain over time. The Water First trial is intended to evaluate these interventions. METHODS Informed by the PRECEDE-PROCEED model and Social Cognitive Theory, the Water First intervention includes: 1) installation of lead-free water stations in cafeterias, physical activity spaces, and high-traffic common areas in lower-income public elementary schools, 2) provision of cups/reusable water bottles for students, and 3) a 6-month healthy beverage education campaign. A five year-long cluster randomized controlled trial of 26 low-income public elementary schools in the San Francisco Bay Area is examining how Water First impacts students' consumption of water, caloric intake from foods and beverages, and BMI z-score and overweight/obesity prevalence, from baseline to 7 months and 15 months after the start of the study. Intervention impact on outcomes will be examined using a difference-in-differences approach with mixed-effects regression accounting for the clustering of students in schools and classrooms. DISCUSSION This paper describes the rationale, study design, and protocol for the Water First study. If the intervention is effective, findings will inform best practices for implementing school water policies, as well as the development of more expansive policies and programs to promote and improve access to drinking water in schools.",2021,"To date, no studies in the United States have examined how a school-based water access and promotion intervention affects students' beverage and food intake both in and out of school and weight gain over time.","['lower-income public elementary schools, 2) provision of cups/reusable water bottles for students, and 3) a 6-month healthy beverage education campaign', ""26 low-income public elementary schools in the San Francisco Bay Area is examining how Water First impacts students' consumption of water, caloric intake from foods and beverages, and BMI z-score and overweight/obesity prevalence, from baseline to 7\u202fmonths and 15\u202fmonths after the start of the study"", 'students in schools and classrooms']",['elementary school drinking water access and promotion intervention'],[],"[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0179376', 'cui_str': 'Bottle'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C3203003', 'cui_str': 'Bays'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0524819', 'cui_str': 'Foods and drinks'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0599638', 'cui_str': 'Drinking Water'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],26.0,0.0599623,"To date, no studies in the United States have examined how a school-based water access and promotion intervention affects students' beverage and food intake both in and out of school and weight gain over time.","[{'ForeName': 'Gala D', 'Initials': 'GD', 'LastName': 'Moreno', 'Affiliation': 'School of Medicine, University of California, San Francisco, USA.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Schmidt', 'Affiliation': 'Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco, USA; Department of Anthropology, History and Social Medicine, University of California, San Francisco, USA.'}, {'ForeName': 'Lorrene D', 'Initials': 'LD', 'LastName': 'Ritchie', 'Affiliation': 'Nutrition Policy Institute, Division of Agriculture and Natural Resources, University of California, Berkeley, USA.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'McCulloch', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Cabana', 'Affiliation': ""Department of Pediatrics, Division of General Pediatrics, Albert Einstein College of Medicine, Children's Hospital at Montefiore, Montefiore, USA.""}, {'ForeName': 'Claire D', 'Initials': 'CD', 'LastName': 'Brindis', 'Affiliation': 'Philip R. Lee Institute for Health Policy Studies, Bixby Center for Global Reproductive Health, Departments of Pediatrics and Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, USA.'}, {'ForeName': 'Lawrence W', 'Initials': 'LW', 'LastName': 'Green', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, USA.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Altman', 'Affiliation': 'School of Public Health, University of California, Berkeley, USA.'}, {'ForeName': 'Anisha I', 'Initials': 'AI', 'LastName': 'Patel', 'Affiliation': 'Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco, USA; Department of Pediatrics, School of Medicine, Stanford University, USA. Electronic address: anipatel@stanford.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106255'] 1788,33370571,"The effect of Nigella sativa on appetite, anthropometric and body composition indices among overweight and obese women: A crossover, double-blind, placebo-controlled, randomized clinical trial.","OBJECTIVES Obesity is a global concern which is associated with several complications and disease. DESIGN Present study is the first crossover, double-blind, placebo-controlled, randomized clinical trial aimed to evaluate the effect of Nigella Sativa (N. sativa) intervention on anthropometric and body composition parameters as well as dietary intake and appetite in a crossover design. METHOD Forty-five healthy women with obesity or overweight were randomized into two groups of intervention and placebo, and the study conducted in two 8-week periods of intervention separated by a 4-week washout period. Anthropometric and body composition indices and dietary intake were measured. Also, appetite sensation was evaluated via a standard visual analog scale (VAS) questionnaire. Pkcross procedure was performed for statistical analysis using STATA. Cohen's d effect size was estimated for all outcomes to determine the magnitude of the effects. RESULTS Supplementation with 2000 mg of N. sativa oil found to have a considerable increment in the measures of body mass index (P < 0.001, Cohen's d = 0.5), body weight (P < 0.001, Cohen's d = 0.6) and waist circumference (P = 0.020, Cohen's d = 0.4) with a medium effect size measure, and a significant decrease in body fat mass (P = 0.019, Cohen's d = 0.2), body fat percent (P < 0.001, Cohen's d = 0.2) and visceral fat area (P = 0.011, Cohen's d = 0.2) with a small effect size measure. CONCLUSION The overall improvements in anthropometric and body composition parameters and a significant decrease in appetite represents the beneficial effects of N. sativa supplements in the treatment of obesity. More studies with different dosages, a larger number of participants, and longer intervention duration are recommended to illustrate the exact effects of N. sativa as a complementary therapy for obesity.",2021,"RESULTS Supplementation with 2000 mg of N. sativa oil found to have a considerable increment in the measures of body mass index (P < 0.001, Cohen's d = 0.5), body weight (P < 0.001, Cohen's d = 0.6) and waist circumference (P = 0.020, Cohen's d = 0.4) with a medium effect size measure, and a significant decrease in body fat mass (P = 0.019, Cohen's d = 0.2), body fat percent (P < 0.001, Cohen's d = 0.2) and visceral fat area (P = 0.011, Cohen's d = 0.2) with a small effect size measure. ","['Forty-five healthy women with obesity or overweight', 'Overweight and Obese Women']","['Placebo', 'Nigella Sativa (N. sativa) intervention', 'placebo', 'Nigella sativa']","['visceral fat area', 'body fat mass', 'body weight', 'Appetite, Anthropometric and Body Composition Indices', 'appetite sensation', 'appetite', 'body mass index', 'standard visual analog scale (VAS) questionnaire', 'waist circumference', 'Anthropometric and body composition indices and dietary intake']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1140702', 'cui_str': 'Cumin, Black'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}]",45.0,0.19204,"RESULTS Supplementation with 2000 mg of N. sativa oil found to have a considerable increment in the measures of body mass index (P < 0.001, Cohen's d = 0.5), body weight (P < 0.001, Cohen's d = 0.6) and waist circumference (P = 0.020, Cohen's d = 0.4) with a medium effect size measure, and a significant decrease in body fat mass (P = 0.019, Cohen's d = 0.2), body fat percent (P < 0.001, Cohen's d = 0.2) and visceral fat area (P = 0.011, Cohen's d = 0.2) with a small effect size measure. ","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Safi', 'Affiliation': 'Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran; Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Razmpoosh', 'Affiliation': 'Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran; Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran; Nutrition and Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossien', 'Initials': 'H', 'LastName': 'Fallahzadeh', 'Affiliation': 'Research Center of Prevention and Epidemiology of Non Communicable Disease, Department of Biostatistics and Epidemiology, Health Faculty, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Mahta', 'Initials': 'M', 'LastName': 'Mazaheri', 'Affiliation': 'Department of Medical Genetics, Faculty of Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran; Mother and Newborn, Health Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Nooshin', 'Initials': 'N', 'LastName': 'Abdollahi', 'Affiliation': 'Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran; Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Nazari', 'Affiliation': 'Department of Medical Genetics, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Nadjarzadeh', 'Affiliation': 'Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran; Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. Electronic address: azadehnajarzadeh@gmail.com.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Salehi-Abargouei', 'Affiliation': 'Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran; Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102653'] 1789,33352487,An alternative analysis of illicit opioid use during treatment in a randomized trial of extended-release naltrexone versus buprenorphine-naloxone: A per-protocol and completers analysis.,"BACKGROUND The distinct pharmacological properties and clinical uses of extended-release naltrexone (XR-NTX) and sublingual buprenorphine-naloxone (BUP-NX) present challenges in analyzing patient outcomes. METHODS We conducted a secondary analysis of a multi-site randomized trial comparing XR-NTX with sublingual BUP-NX treatment for opioid use disorder initiated during inpatient detoxification and continued in outpatient treatment. Urine testing data for non-study opioids from the last 22 weeks of the 24-week trial were analyzed in both a per-protocol sample (n = 474 participants who received at least one dose of medication) and a completers sample (n = 211 participants who received all XR-NTX doses or all BUP-NX prescriptions). The present analyses sought to identify differences in the weekly percentages of opioid-positive urine tests between participants treated with the two medications. RESULTS The proportion of opioid-positive tests in both conditions was less than 20 % for 21 of the 22 weeks in the per-protocol sample and all 22 weeks in the completers sample. Generalized linear mixed model analyses revealed a significant treatment (XR-NTX vs. BUP-NX) X week (weeks 3-24) interaction in the per-protocol sample but not the completers sample. In the per-protocol analysis, the BUP-NX, compared to XR-NTX, had significantly greater proportions of opioid-positive tests in 14 out of the 22 weeks. CONCLUSIONS Longitudinal modeling approaches that utilize flexible procedures for handling missing data can offer a different perspective on study findings. Results from the present analyses suggest that XR-NTX appeared to be somewhat more effective than BUP-NX in reducing illicit opioid use in the per-protocol sample.",2021,"In the per-protocol analysis, the BUP-NX, compared to XR-NTX, had significantly greater proportions of opioid-positive tests in 14 out of the 22 weeks. ","['participants treated with the two medications', 'non-study opioids from the last 22 weeks of the 24-week trial were analyzed in both a per-protocol sample (n = 474 participants who received at least one dose of medication) and a completers sample (n = 211 participants who received']","['buprenorphine-naloxone', 'naltrexone', 'BUP-NX', 'all XR-NTX doses or all BUP-NX prescriptions', 'naltrexone (XR-NTX) and sublingual buprenorphine-naloxone (BUP-NX', 'XR-NTX with sublingual BUP-NX']","['proportion of opioid-positive tests', 'illicit opioid use']","[{'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C1169989', 'cui_str': 'Buprenorphine- and naloxone-containing product'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332266', 'cui_str': 'Illicit'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",474.0,0.0498073,"In the per-protocol analysis, the BUP-NX, compared to XR-NTX, had significantly greater proportions of opioid-positive tests in 14 out of the 22 weeks. ","[{'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'Mitchell', 'Affiliation': 'Friends Research Institute, Baltimore, MD, USA. Electronic address: mmitchell@friendsresearch.org.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Schwartz', 'Affiliation': 'Friends Research Institute, Baltimore, MD, USA.'}, {'ForeName': 'Tse-Hwei', 'Initials': 'TH', 'LastName': 'Choo', 'Affiliation': 'New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY, 10031, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': 'Department of Biostatistics, Mailman School of Public Health, Columbia University, 722 West 168th St, New York, NY, 10032, USA.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': ""O'Grady"", 'Affiliation': 'Department of Psychology, University of Maryland, College Park, College Park, MD, 20742, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Gryczynski', 'Affiliation': 'Friends Research Institute, Baltimore, MD, USA.'}, {'ForeName': 'Maxine L', 'Initials': 'ML', 'LastName': 'Stitzer', 'Affiliation': 'Friends Research Institute, Baltimore, MD, USA.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY, 10031, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rotrosen', 'Affiliation': 'New York University School of Medicine, 550 1st Avenue, New York, NY, 10016, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108422'] 1790,33384265,The short-term effects of manual and interactive powered toothbrushes on the periodontal status of orthodontic patients: A randomized clinical trial.,"OBJECTIVE To compare the effects of manual and interactive powered toothbrushes on periodontal status of patients during fixed orthodontic treatment. MATERIALS AND METHODS Thirty-six patients aged 12 to 18 years were included in this parallel design randomized clinical trial. Patients were randomly divided into two groups: manual toothbrushes (MT group) and interactive powered toothbrushes (PT group). The plaque index (PI), gingival index (GI), and bleeding on probing (BOP) scores were obtained before brushing (T0), 4 weeks (T1), 2 months (T2), and 4 months (T3) after brushing initiation. Periodontal measurements were performed by the same researcher that blinded to the groups' randomization. Data were analyzed with Mann-Whitney U and Friedman tests for the comparison of parameters between groups and times. RESULTS Significant differences were found in PI values at all time intervals (P < 0.001), with one exception (T2-T3 in the MT group). The GI changes between timepoints were parallel to the BOP findings of the PT group. Both groups had significantly lower bleeding scores in both T0-T2 and T0-T3 time intervals (P < 0.001). There was a significant reduction in the bleeding score of PT group between T1-T3 time interval (P < 0.05); however, there were no significant differences between the groups at any timepoint. PI and GI scores were statistically decreased in the PT group compared with the MT group from baseline to 4 months (P < 0.05). CONCLUSION All periodontal parameters decreased during the 4-month study period. The interactive powered toothbrushes may be an alternative to manual toothbrushes in terms of maintenance of periodontal health during fixed orthodontic treatment.",2021,Both groups had significantly lower bleeding scores in both T0-T2 and T0-T3 time intervals (P < 0.001).,"['orthodontic patients', 'patients during fixed orthodontic treatment', 'Thirty-six patients aged 12 to 18\xa0years']","['manual toothbrushes (MT group) and interactive powered toothbrushes (PT group', 'manual and interactive powered toothbrushes']","['bleeding scores', 'bleeding score', 'PI values', 'plaque index (PI), gingival index (GI), and bleeding on probing (BOP) scores', 'PI and GI scores']","[{'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0490733', 'cui_str': 'Manual toothbrush'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0182400', 'cui_str': 'Probe'}]",36.0,0.0272374,Both groups had significantly lower bleeding scores in both T0-T2 and T0-T3 time intervals (P < 0.001).,"[{'ForeName': 'Yılmaz Zafer', 'Initials': 'YZ', 'LastName': 'Bilen', 'Affiliation': 'Specialist Orthodontics, Private Clinic, Manisa, Turkey.'}, {'ForeName': 'Serpil', 'Initials': 'S', 'LastName': 'Çokakoğlu', 'Affiliation': 'Assistant Professor, Department of Orthodontics, Faculty of Dentistry, Pamukkale University, Denizli, Turkey. Electronic address: serpilcokakoglu@gmail.com.'}, {'ForeName': 'Fırat', 'Initials': 'F', 'LastName': 'Öztürk', 'Affiliation': 'Associate Professor, Private Clinic, Denizli, Turkey.'}]",Journal of the World federation of orthodontists,['10.1016/j.ejwf.2020.11.003'] 1791,33384201,Re: Randomized Comparison of Techniques for Control of the Dorsal Venous Complex During Robot-assisted Laparoscopic Radical Prostatectomy.,,2021,,[],['Robot-assisted Laparoscopic Radical Prostatectomy'],[],[],"[{'cui': 'C4039115', 'cui_str': 'Robot assisted laparoscopic radical prostatectomy'}]",[],,0.0326364,,"[{'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Davis', 'Affiliation': 'Department of Urology, MD Anderson Cancer Center, Houston, TX, USA. Electronic address: johndavis@mdanderson.org.'}]",European urology,['10.1016/j.eururo.2020.12.007'] 1792,33386662,Biological stratification of clinical disease courses in childhood immune thrombocytopenia.,"BACKGROUND In childhood immune thrombocytopenia (ITP), an autoimmune bleeding disorder, there is a need for better prediction of individual disease courses and treatment outcomes. OBJECTIVE To predict the response to intravenous immunoglobulins (IVIg) and ITP disease course using genetic and immune markers. METHODS Children aged younger than 7 years with newly diagnosed ITP (N = 147) from the Treatment With or Without IVIG for Kids with ITP study were included, which randomized children to an IVIg or observation group. A total of 46 variables were available: clinical characteristics, targeted genotyping, lymphocyte immune phenotyping, and platelet autoantibodies. RESULTS In the treatment arm, 48/80 children (60%) showed a complete response (platelets ≥100 × 10 9 /L) that lasted for at least 1 month (complete sustained response [CSR]) and 32 exhibited no or a temporary response (absence of a sustained response [ASR]). For a biological risk score, five variables were selected by regularized logistic regression that predicted ASR vs CSR: (1) hemoglobin; (2) platelet count; (3) genetic polymorphisms of Fc-receptor (FcγR) IIc; (4) the presence of immunoglobulin G (IgG) anti-platelet antibodies; and (5) preceding vaccination. The ASR sensitivity was 0.91 (95% confidence interval, 0.80-1.00) and specificity was 0.67 (95% confidence interval, 0.53-0.80). In the 67 patients of the observation arm, this biological score was also associated with recovery during 1 year of follow-up. The addition of the biological score to a predefined clinical score further improved the discrimination of favorable ITP disease courses. CONCLUSIONS The prediction of disease courses and IVIg treatment responses in ITP is improved by using both clinical and biological stratification.",2021,"The ASR sensitivity was 0.91 (95% CI, 0.80 - 1.00) and specificity was 0.67 (95% CI, 0.53 - 0.80).","['childhood immune thrombocytopenia', 'Children aged below seven years with newly diagnosed ITP (N = 147) from the TIKI study were included, which randomized children to an IVIg or observation group']",[],"['complete response', 'specificity', 'ASR sensitivity']","[{'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0242584', 'cui_str': 'Autoimmune thrombocytopenia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",147.0,0.121791,"The ASR sensitivity was 0.91 (95% CI, 0.80 - 1.00) and specificity was 0.67 (95% CI, 0.53 - 0.80).","[{'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Schmidt', 'Affiliation': 'Sanquin Research, Department of Experimental Immunohematology, Amsterdam, The Netherlands.'}, {'ForeName': 'Katja M J', 'Initials': 'KMJ', 'LastName': 'Heitink-Pollé', 'Affiliation': ""Department of Pediatric Hematology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands.""}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Mertens', 'Affiliation': 'Department of Medical Statistics, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Leendert', 'Initials': 'L', 'LastName': 'Porcelijn', 'Affiliation': 'Department of Immunohematology Diagnostics, Sanquin Diagnostic Services, Amsterdam, The Netherlands.'}, {'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'Kapur', 'Affiliation': 'Sanquin Research, Department of Experimental Immunohematology, Amsterdam, The Netherlands.'}, {'ForeName': 'C Ellen', 'Initials': 'CE', 'LastName': 'van der Schoot', 'Affiliation': 'Sanquin Research, Department of Experimental Immunohematology, Amsterdam, The Netherlands.'}, {'ForeName': 'Gestur', 'Initials': 'G', 'LastName': 'Vidarsson', 'Affiliation': 'Sanquin Research, Department of Experimental Immunohematology, Amsterdam, The Netherlands.'}, {'ForeName': 'Johanna G', 'Initials': 'JG', 'LastName': 'van der Bom', 'Affiliation': 'Sanquin Research, Center for Clinical Transfusion Research, Leiden, The Netherlands.'}, {'ForeName': 'Marrie C A', 'Initials': 'MCA', 'LastName': 'Bruin', 'Affiliation': ""Department of Pediatric Hematology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands.""}, {'ForeName': 'Masja', 'Initials': 'M', 'LastName': 'de Haas', 'Affiliation': 'Department of Immunohematology Diagnostics, Sanquin Diagnostic Services, Amsterdam, The Netherlands.'}]",Journal of thrombosis and haemostasis : JTH,['10.1111/jth.15232'] 1793,33245949,A case-control study to identify molecular risk factors for local recurrence in young breast cancer patients.,"PURPOSE To investigate risk factors for local recurrence (LR) after breast conserving therapy in young breast cancer patients randomized in the ""Young Boost Trial"". MATERIAL & METHODS In the ""Young Boost Trial"" 2421 patients ≤50 years old were randomized between a 16 Gy and 26 Gy boost after breast conserving surgery and whole breast radiation (50 Gy). We performed a case-control study comparing patients who developed a LR (cases) and for each of them three control patients free of recurrence (controls). Clinicopathological factors, copy number- and gene expression profiles of primary tumors were compared between cases and controls, and between primary tumors and local recurrences. RESULTS The cumulative 5-year LR rate was 1.07% (95% CI 0.72-1.59%) and 10-year LR rate 2.56% (1.81-3.62%). Analysis of a subset of primary tumors and local recurrences showed similar histopathological characteristics (n = 15), copy number (n = 13) and gene expression profiles (n = 14). Basal subtype was strongly associated with LR in univariable and multivariable analysis. Gains of CCND1 were identified more frequently among controls, while more frequent gains of FGFR1 and IGF1R were observed among cases. Upregulation of genes involved in the p53-pathway was observed in recurring tumors compared to non-recurring tumors. We could not identify a genomic classifier for LR. CONCLUSIONS All investigated local recurrences were true genomic recurrences. Although differences in copy number variation and gene expression pathways were observed in recurring tumors compared to non-recurring tumors, no genomic classifier for LR could be identified.",2021,Upregulation of genes involved in the p53-pathway was observed in recurring tumors compared to non-recurring tumors.,"['young breast cancer patients', 'patients who developed a LR (cases) and for each of them three control patients free of recurrence (controls', '2421 patients ≤50 years old']","['breast conserving therapy', '16 Gy and 26 Gy boost after breast conserving surgery and whole breast radiation (50 Gy']","['FGFR1 and IGF1R', 'cumulative 5-year LR rate', 'Clinicopathological factors, copy number- and gene expression profiles of primary tumors', 'Gains of CCND1', '10-year LR rate']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C1527757', 'cui_str': 'FGFR1 protein, human'}, {'cui': 'C0140080', 'cui_str': 'Insulin-Like-Growth Factor I Receptor'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1449575', 'cui_str': 'Microarray Analysis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1741716', 'cui_str': 'CCND1 protein, human'}]",2421.0,0.0545585,Upregulation of genes involved in the p53-pathway was observed in recurring tumors compared to non-recurring tumors.,"[{'ForeName': 'Sophie C J', 'Initials': 'SCJ', 'LastName': 'Bosma', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands. Electronic address: s.bosma@nki.nl.'}, {'ForeName': 'Marlous', 'Initials': 'M', 'LastName': 'Hoogstraat', 'Affiliation': 'Department of Bioinformatics, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'van Werkhoven', 'Affiliation': 'Department of Statistics, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'de Maaker', 'Affiliation': 'Department of Molecular Pathology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Femke', 'Initials': 'F', 'LastName': 'van der Leij', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Paula H M', 'Initials': 'PHM', 'LastName': 'Elkhuizen', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Fourquet', 'Affiliation': 'Department of Radiation Oncology, Institute Curie, Paris, France.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Poortmans', 'Affiliation': 'Department of Radiation Oncology, Institute Curie, Paris, France; Department of Radiation Oncology, Iridium Netwerk, Wilrijk Antwerp, Belgium; University of Antwerp, Edegem Antwerp, Belgium.'}, {'ForeName': 'Liesbeth J', 'Initials': 'LJ', 'LastName': 'Boersma', 'Affiliation': 'Department of Radiation Oncology (MAASTRO), GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre, The Netherlands.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Bartelink', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'van de Vijver', 'Affiliation': 'Department of Pathology, Amsterdam UMC, Amsterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.11.025'] 1794,33393402,Lower Limb Sensorimotor Training (LoSenseT) for Children and Adolescents with Cerebral Palsy: A Brief Report of a Feasibility Randomized Protocol.,"Motor disorders in cerebral palsy (CP) are often accompanied by disturbances of sensation and impaired somatosensory functions have been reported in individuals with CP. To test the feasibility of a sensorimotor training protocol for lower limbs in children and adolescents with unilateral and bilateral CP, and to analyze the preliminary effects of this training on sensory and motor variables. This is a single-blind, prospective phase I feasibility randomized protocol. A total of twenty participants with uni or bilateral cerebral palsy, GMFCS level I-III, ages 5 to 20 years will be recruited. The LoSenseT protocol is composed of tactile and proprioceptive activities in a child-friendly format. An original qualitative feedback questionnaire was developed to assess the protocol feasibility. Additionally, proprioception, tactile discrimination, postural stability, and gait parameters will be assessed. The LoSenseT protocol can support the implementation of interventions targeting lower limbs somatosensory impairments in individuals with CP.",2021,"To test the feasibility of a sensorimotor training protocol for lower limbs in children and adolescents with unilateral and bilateral CP, and to analyze the preliminary effects of this training on sensory and motor variables.","['twenty participants with uni or bilateral cerebral palsy, GMFCS level I-III, ages 5 to 20\xa0years will be recruited', 'individuals with CP', 'cerebral palsy (CP', 'Children and Adolescents with Cerebral Palsy', 'children and adolescents with unilateral and bilateral CP']","['Lower Limb Sensorimotor Training (LoSenseT', 'sensorimotor training protocol']","['proprioception, tactile discrimination, postural stability, and gait parameters']","[{'cui': 'C3853222', 'cui_str': 'Sea urchin - dietary'}, {'cui': 'C3838784', 'cui_str': 'Bilateral cerebral palsy'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",20.0,0.0268237,"To test the feasibility of a sensorimotor training protocol for lower limbs in children and adolescents with unilateral and bilateral CP, and to analyze the preliminary effects of this training on sensory and motor variables.","[{'ForeName': 'Camila Araújo Santos', 'Initials': 'CAS', 'LastName': 'Santana', 'Affiliation': 'Department of Physical Therapy, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.'}, {'ForeName': 'Eloisa', 'Initials': 'E', 'LastName': 'Tudella', 'Affiliation': 'Department of Physical Therapy, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.'}, {'ForeName': 'Nelci Adriana Cicuto Ferreira', 'Initials': 'NACF', 'LastName': 'Rocha', 'Affiliation': 'Department of Physical Therapy, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.'}, {'ForeName': 'Ana Carolina', 'Initials': 'AC', 'LastName': 'de Campos', 'Affiliation': 'Department of Physical Therapy, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.'}]",Developmental neurorehabilitation,['10.1080/17518423.2020.1858458'] 1795,33392835,Safety and efficacy of abemaciclib plus endocrine therapy in older patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: an age-specific subgroup analysis of MONARCH 2 and 3 trials.,"PURPOSE Abemaciclib in combination with endocrine therapy (ET) has demonstrated significant efficacy benefits in HR+ , HER2- advanced breast cancer patients in the Phase 3 studies MONARCH 2 (fulvestrant as ET) and MONARCH 3 (letrozole or anastrozole as ET). Here, we report age-specific safety and efficacy outcomes. METHODS Exploratory analyses of MONARCH 2 and 3 were performed for 3 age groups (<65, 65-74, and ≥75 years). For safety, data were pooled from both studies; for efficacy, a subgroup analysis of PFS was performed for each trial independently. RESULTS Pooled safety data were available for 1152 patients. Clinically relevant diarrhea (Grade 2/3) was higher in older patients receiving abemaciclib + ET (<65, 39.5%; 65-74, 45.2%; ≥75, 55.4%) versus placebo + ET (<65, 6.8%; 65-74, 4.5%; ≥75, 16.0%). Nausea, decreased appetite, and venous thromboembolic events were all moderately higher in older patients. Neutropenia (Grade ≥ 3) did not differ as a function of age in the abemaciclib + ET arm (<65, 25.8%; 65-74, 27.4%; ≥75, 18.1%). Dose adjustments and discontinuation rates were slightly higher in older patients. Abemaciclib + ET improved PFS compared with placebo + ET independent of patient age, with no significant difference in abemaciclib treatment effect between the 3 age groups (MONARCH 2: interaction p-value, 0.695; MONARCH 3: interaction p-value, 0.634). Estimated hazard ratios ranged from 0.523-0.633 (MONARCH 2) and 0.480-0.635 (MONARCH 3). CONCLUSIONS While higher rates of adverse events were reported in older patients, they were manageable with dose adjustments and concomitant medication. Importantly, a consistent efficacy benefit was observed across all age groups. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov: NCT02107703 (first posted April 8, 2014) and NCT02246621 (first posted September 23, 2014).",2021,"Estimated hazard ratios ranged from 0.523-0.633 (MONARCH 2) and 0.480-0.635 (MONARCH 3). ","['older patients', '1152 patients', 'HER2- advanced breast cancer patients', 'Exploratory analyses of MONARCH 2 and 3 were performed for 3 age groups (<65, 65-74, and\u2009≥75\xa0years', 'older patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer']","['endocrine therapy (ET', 'MONARCH 3 (letrozole or anastrozole', 'placebo', 'abemaciclib plus endocrine therapy']","['PFS', 'Neutropenia', 'Clinically relevant diarrhea', 'efficacy benefit', 'abemaciclib treatment effect', 'adverse events', 'Safety and efficacy', 'discontinuation rates', 'Nausea, decreased appetite, and venous thromboembolic events']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]","[{'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0290883', 'cui_str': 'anastrozole'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3852841', 'cui_str': 'abemaciclib'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3852841', 'cui_str': 'abemaciclib'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}]",,0.0784905,"Estimated hazard ratios ranged from 0.523-0.633 (MONARCH 2) and 0.480-0.635 (MONARCH 3). ","[{'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Goetz', 'Affiliation': 'Department of Oncology, Mayo Clinic, 200 First St. S.W, Rochester, MN, 55905, USA. Goetz.Matthew@mayo.edu.'}, {'ForeName': 'Meena', 'Initials': 'M', 'LastName': 'Okera', 'Affiliation': 'Adelaide Cancer Center, Adelaide, Australia.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Wildiers', 'Affiliation': 'Department of General Medical Oncology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Campone', 'Affiliation': ""Institut de Cancerologie de L'Ouest-René Gauducheau, Saint Herblain, France.""}, {'ForeName': 'Eva-Maria', 'Initials': 'EM', 'LastName': 'Grischke', 'Affiliation': ""Women's Hospital, University Hospital Tübingen, Tübingen, Germany.""}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Manso', 'Affiliation': '12 de Octubre University Hospital, Madrid, Spain.'}, {'ForeName': 'Valérie A M', 'Initials': 'VAM', 'LastName': 'André', 'Affiliation': 'Eli Lilly and Company, Paris, France.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Chouaki', 'Affiliation': 'Eli Lilly and Company, Paris, France.'}, {'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'San Antonio', 'Affiliation': 'Eli Lilly and Company, Madrid, Spain.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Toi', 'Affiliation': 'Breast Cancer Unit, Kyoto University Hospital, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Sledge', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}]",Breast cancer research and treatment,['10.1007/s10549-020-06029-y'] 1796,33389320,Life in the Balance: Young Female Sex Workers in Kenya Weigh the Risks of COVID-19 and HIV.,"The COVID-19 pandemic has had serious health, economic and psychosocial consequences. Marginalized populations including female sex workers face the stark choice of risking exposure to SARS-CoV-2 as they engage with clients or prioritizing their health at the cost of losing a primary source of income. As part of an ongoing open-label, randomized controlled trial providing daily oral pre-exposure prophylaxis and adherence support, we interviewed 193 of 200 enrolled young female sex workers (18-24 years) in Kisumu, Kenya, about COVID-19 awareness and precautions, access to health services, and sex work during Kenya's pandemic-related lockdown. Nearly all participants were aware of COVID-19 and reported taking protective measures, but only half reported concerns about acquiring SARS-CoV-2. Night curfews and bar closures adversely affected participants' sex work business, reducing the number of clients and payment amounts from clients. Nearly 15% experienced violence from a client or regular, non-paying sex partner during the lockdown period. Participants' access to healthcare services was not disrupted.",2021,"Night curfews and bar closures adversely affected participants' sex work business, reducing the number of clients and payment amounts from clients.","['Balance', 'Young Female Sex Workers in Kenya Weigh the Risks of COVID-19 and HIV', ""interviewed 193 of 200 enrolled young female sex workers (18-24\xa0years) in Kisumu, Kenya, about COVID-19 awareness and precautions, access to health services, and sex work during Kenya's pandemic-related lockdown"", 'female sex workers']",[],"[""Night curfews and bar closures adversely affected participants' sex work business""]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0033595', 'cui_str': 'Works as prostitute'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]",[],"[{'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0033595', 'cui_str': 'Works as prostitute'}, {'cui': 'C0085936', 'cui_str': 'Business'}]",200.0,0.0247491,"Night curfews and bar closures adversely affected participants' sex work business, reducing the number of clients and payment amounts from clients.","[{'ForeName': 'Joanne E', 'Initials': 'JE', 'LastName': 'Mantell', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, Columbia University Irving Medical Center, New York, NY, USA. jem57@cumc.columbia.edu.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Franks', 'Affiliation': 'Mailman School of Public Health, ICAP at Columbia University, New York, NY, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Lahuerta', 'Affiliation': 'Mailman School of Public Health, ICAP at Columbia University, New York, NY, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Omollo', 'Affiliation': 'IMPACT Research and Development Organization, Kisumu, Kenya.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Zerbe', 'Affiliation': 'Mailman School of Public Health, ICAP at Columbia University, New York, NY, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hawken', 'Affiliation': 'Mailman School of Public Health, ICAP at Columbia University, New York, NY, USA.'}, {'ForeName': 'Yingfeng', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Mailman School of Public Health, ICAP at Columbia University, New York, NY, USA.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Odera', 'Affiliation': 'Mailman School of Public Health, ICAP at Columbia University, New York, NY, USA.'}, {'ForeName': 'Wafaa M', 'Initials': 'WM', 'LastName': 'El-Sadr', 'Affiliation': 'Mailman School of Public Health, ICAP at Columbia University, New York, NY, USA.'}, {'ForeName': 'Kawango', 'Initials': 'K', 'LastName': 'Agot', 'Affiliation': 'IMPACT Research and Development Organization, Kisumu, Kenya.'}]",AIDS and behavior,['10.1007/s10461-020-03140-5'] 1797,33393484,Effect of Mindfulness Meditation on Intraocular Pressure and Trabecular Meshwork Gene Expression: A Randomized Controlled Trial.,"PURPOSE To evaluate the effect of mindfulness meditation (MM) on intraocular pressure (IOP) and trabecular meshwork (TM) gene expression in patients with medically uncontrolled primary open angle glaucoma (POAG). DESIGN Parallel arm, single-masked, randomized controlled trial. METHODS Sixty POAG patients with IOP ≥21 mm Hg taking maximal topical medication and scheduled for trabeculectomy were included in this study at a tertiary eye care center in India. Thirty patients (Group 1) underwent 3 weeks of 45-minute daily MM sessions in addition to medical therapy while Group 2 continued medical therapy only. Primary outcome was change in IOP (ΔIOP) after 3 weeks of MM. Secondary outcomes were probability of success, percentage of reduction in IOP, effect on diurnal variations of IOP, changes in quality of life (QoL), and changes in gene expression patterns in TM. RESULTS At 3 weeks, a significant decrease in IOP was seen in Group 1 (20.16 ± 3.3 to 15.05 ± 2.4mm Hg; P = .001), compared to Group 2 (21.2 ± 5.6 to 20.0 ± 5.8mm Hg; P = .38). ΔIOP was significantly higher in Group 1 than in Group 2 (5.0 ± 1.80 vs. 0.20 ± 3.03mm Hg; P = .001). Analysis of gene expression revealed significant upregulation of nitric oxide synthetase (NOS1 and NOS3) and neuroprotective genes with downregulation of proinflammatory genes in Group 1 in comparison to Group 2 (P = .001). CONCLUSIONS MM was associated with significant decrease in IOP and changes in TM gene expression, indicating its direct impact on ocular tissues.",2021,"Analysis of gene expression revealed significant upregulation of nitric oxide synthetase (NOS1 and NOS3) and neuroprotective genes with downregulation of proinflammatory genes in Group 1 in comparison to Group 2 (P = .001). ","['patients with medically uncontrolled primary open angle glaucoma (POAG', 'Sixty POAG patients with IOP ≥21\xa0mm']","['Hg taking maximal topical medication and scheduled for trabeculectomy', 'mindfulness meditation (MM', 'Mindfulness Meditation']","['nitric oxide synthetase (NOS1 and NOS3) and neuroprotective genes with downregulation of proinflammatory genes', 'Intraocular Pressure and Trabecular Meshwork Gene Expression', 'IOP and changes in TM gene expression', 'IOP', 'change in IOP (ΔIOP', 'probability of success, percentage of reduction in IOP, effect on diurnal variations of IOP, changes in quality of life (QoL), and changes in gene expression patterns in TM', 'intraocular pressure (IOP) and trabecular meshwork (TM) gene expression', 'ΔIOP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}]","[{'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]","[{'cui': 'C0132555', 'cui_str': 'Nitric-oxide synthase'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0669365', 'cui_str': 'NOS3 protein, human'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0013081', 'cui_str': 'Down-regulation'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0040573', 'cui_str': 'Trabecular meshwork structure'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0008810', 'cui_str': 'Circadian rhythm'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",60.0,0.28744,"Analysis of gene expression revealed significant upregulation of nitric oxide synthetase (NOS1 and NOS3) and neuroprotective genes with downregulation of proinflammatory genes in Group 1 in comparison to Group 2 (P = .001). ","[{'ForeName': 'Tanuj', 'Initials': 'T', 'LastName': 'Dada', 'Affiliation': 'Dr. Rajendra Prasad Center for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India. Electronic address: tanujdada@gmail.com.'}, {'ForeName': 'Nithya', 'Initials': 'N', 'LastName': 'Bhai', 'Affiliation': 'Dr. Rajendra Prasad Center for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Midha', 'Affiliation': 'Dr. Rajendra Prasad Center for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Shakrawal', 'Affiliation': 'Dr. Rajendra Prasad Center for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Kumar', 'Affiliation': 'Laboratory for Molecular Reproduction and Genetics, Department of Anatomy, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Chaurasia', 'Affiliation': 'Laboratory for Molecular Reproduction and Genetics, Department of Anatomy, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Shikha', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Dr. Rajendra Prasad Center for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Dewang', 'Initials': 'D', 'LastName': 'Angmo', 'Affiliation': 'Dr. Rajendra Prasad Center for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rajkumar', 'Initials': 'R', 'LastName': 'Yadav', 'Affiliation': 'Integrated Health Clinic, Department of Physiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Dada', 'Affiliation': 'Laboratory for Molecular Reproduction and Genetics, Department of Anatomy, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ramanjit', 'Initials': 'R', 'LastName': 'Sihota', 'Affiliation': 'Dr. Rajendra Prasad Center for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.10.012'] 1798,33401232,"The effectiveness of mobilization with movement on pain, balance and function following acute and sub acute inversion ankle sprain - A randomized, placebo controlled trial.","OBJECTIVES To determine the effect of mobilization with movement (MWM) on pain, ankle mobility and function in patients with acute and sub-acute grade I and II inversion ankle sprain. STUDY DESIGN Randomized placebo controlled trial. SETTING A general hospital. SUBJECTS 32 adults with inversion ankle sprain. MAIN OUTCOME MEASURES The primary outcome was pain intensity on an 11 point Numeric Rating Scale (NRS) with higher score indicating greater pain intensity. Ankle disability identified by the Foot and Ankle Disability index (FADI) with higher score indicating lower disability, functional ankle dorsiflexion range, pressure pain threshold, and dynamic balance measured with the Y balance test were secondary outcomes. RESULTS Thirty participants completed the study. At each follow-up point, significant differences were found between groups favouring those receiving MWM for all variables. Pain intensity showed a mean difference of 1.7 points (95% confidence interval, 1.4 to 2.1) and 0.9 points (95% confidence interval, 0.5 to 1.3) at one and six-months follow-up respectively. Benefits were also shown for FADI, ankle mobility, pressure pain threshold and balance. CONCLUSION This study provides preliminary data for the benefits of MWM for acute and sub-acute ankle sprain in terms of pain, ankle mobility, disability and balance.",2021,"At each follow-up point, significant differences were found between groups favouring those receiving MWM for all variables.","['Thirty participants completed the study', '32 adults with inversion ankle sprain', 'patients with acute and sub-acute grade I and II inversion ankle sprain', 'A general hospital']","['MWM', 'placebo', 'mobilization with movement (MWM']","['Ankle disability identified by the Foot and Ankle Disability index (FADI', 'disability, functional ankle dorsiflexion range, pressure pain threshold, and dynamic balance', 'pain intensity', 'FADI, ankle mobility, pressure pain threshold and balance', 'pain, balance and function', 'pain, ankle mobility and function', 'pain intensity on an 11 point Numeric Rating Scale (NRS', 'Pain intensity']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021943', 'cui_str': 'Chromosome inversion'}, {'cui': 'C0160087', 'cui_str': 'Sprain of ankle'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}]","[{'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",32.0,0.355875,"At each follow-up point, significant differences were found between groups favouring those receiving MWM for all variables.","[{'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Gogate', 'Affiliation': 'Department of Musculoskeletal Physiotherapy, Smt. Kashibai Navale College of Physiotherapy, Pune, Maharashtra, India.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Satpute', 'Affiliation': 'Department of Musculoskeletal Physiotherapy, Smt. Kashibai Navale College of Physiotherapy, Pune, Maharashtra, India. Electronic address: kiran_ptist@yahoo.co.in.'}, {'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Hall', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, P.O. Box U1987, Perth, WA, 6845, Australia.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.12.016'] 1799,33405182,One Anastomosis Gastric Bypass in Patients with Gastrooesophageal Reflux Disease and/or Hiatus Hernia.,"INTRODUCTION One anastomosis gastric bypass (OAGB) offers favourable weight loss outcomes and is associated with reduced morbidity and mortality when compared to other mainstream bariatric procedures. However, a randomised trial reported a conversion rate to roux-en-Y configuration (RYC) of 3.1%, and some surgeons consider the procedure unsuitable for patients with a preoperative hiatus hernia (HH) or symptoms of gastrooesophageal reflux disease (GORD). METHODS We carried out a retrospective review of patients undergoing OAGB in our institution. Included were all patients on PPI for symptoms of GORD preoperatively, as well as patients with HH or oesophagitis on preoperative endoscopy. We recorded GORD outcomes as well as rates of conversion to RYC in patients. RESULTS Medium term follow up data at 23-28 months was available for 89 patients. Of these, 63 had HH, 34 had preoperative GORD requiring PPI and 9 had confirmed oesophagitis. The conversion rate to RYC was nil (0/63) in patients with HH. At the same time, 14.7% (5/34) of patients with preop GORD on PPI required conversion to RYC at a median time interval of 16 months. In patients already on PPI preoperatively, 16/34 (47.1%) needed to continue on PPI long term. In patients with HH, 20.6% (13/63) suffered de novo GORD symptoms. CONCLUSION OAGB can be offered to patients with HH with acceptable GORD outcomes but caution is advised in patients with preoperative GORD symptoms. Larger prospective and randomised studies are required to further assess this subgroup.",2021,The conversion rate to RYC was nil (0/63) in patients with HH.,"['patients with HH or oesophagitis on preoperative endoscopy', 'patients with a preoperative hiatus hernia (HH) or symptoms of gastrooesophageal reflux disease (GORD', 'Patients with Gastrooesophageal Reflux Disease and/or Hiatus Hernia', 'patients undergoing OAGB in our institution']","['anastomosis gastric bypass (OAGB', 'OAGB', 'Anastomosis Gastric Bypass']","['oesophagitis', 'conversion rate to RYC', 'suffered de novo GORD symptoms', 'rates of conversion to RYC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376710', 'cui_str': 'Sliding hiatus hernia'}, {'cui': 'C0014868', 'cui_str': 'Esophagitis'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}]","[{'cui': 'C0014868', 'cui_str': 'Esophagitis'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0002804', 'cui_str': 'Roux-en-Y - action'}, {'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0233377,The conversion rate to RYC was nil (0/63) in patients with HH.,"[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Winstanley', 'Affiliation': 'Bariatric Unit, Sunderland Royal Hospital, Sunderland, SR4 7TP, UK. dr.jpwinstanley@gmail.com.'}, {'ForeName': 'Salman', 'Initials': 'S', 'LastName': 'Ahmed', 'Affiliation': 'Bariatric Unit, Sunderland Royal Hospital, Sunderland, SR4 7TP, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Courtney', 'Affiliation': 'Bariatric Unit, Sunderland Royal Hospital, Sunderland, SR4 7TP, UK.'}, {'ForeName': 'Miraheal', 'Initials': 'M', 'LastName': 'Sam', 'Affiliation': 'Bariatric Unit, Sunderland Royal Hospital, Sunderland, SR4 7TP, UK.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Mahawar', 'Affiliation': 'Bariatric Unit, Sunderland Royal Hospital, Sunderland, SR4 7TP, UK.'}]",Obesity surgery,['10.1007/s11695-020-05149-0'] 1800,33404895,"Bronchodilating effects of a new beclometasone dipropionate plus formoterol fumarate formulation via pressurized metered-dose inhaler in asthmatic children: a double-blind, randomized, cross-over clinical study.","A new pediatric fixed combination of beclometasone dipropionate (BDP) 50 μg and formoterol fumarate (FF) 6 μg via pressurized metered-dose inhaler (pMDI) (CHF1535, Chiesi, Italy) was investigated. In a double-blind, randomized, placebo-controlled, cross-over study, a single CHF1535 administration using AeroChamber Plus™ spacer device (2 actuations, total dose BDP 100 μg/FF 12 μg) was compared to the same pMDI free combination in 56 asthmatic children aged ≥ 5 and < 12 years. Primary efficacy variable was forced expiratory volume during the first second (FEV 1 ) area under the curve corrected by time over 12 h following morning dose (AUC 0-12h ). Further CHF1535 doses (50 μg/6 μg, 100 μg/12 μg, and 200 μg/24 μg) were also explored. Adverse events, electrocardiogram, and vital signs were monitored for safety. CHF1535 was non-inferior to free combination [adjusted mean difference (95% CI) 0.004 L (- 0.050, 0.041] with lower confidence limit greater than the limit set at 0.1 L. FEV 1 AUC 0-12h of each CHF1535 dose vs placebo were 0.037 L (p = 0.160), 0.119 L (p < 0.001), and 0.094 (p < 0.001) for 50/6, 100/12, and 200/24, respectively. No safety signals were found.Conclusion: CHF1535 was as effective as free combination BDP/FF, with a trend towards a dose-related response. All treatments were safe.Trial registration: ClinicalTrials.gov ID: NCT01584492 What is Known: •Inhaled pressurized metered-dose solutions (pMDI) are the preferred treatment for pediatric asthma. •Combination therapy of inhaled corticosteroids and long-acting β 2 - agonists is a well-established approach to control airway inflammation and airway obstruction also in pediatric patients. What is New: •A novel pediatric pMDI fixed combination of beclomethasone dipropionate 50 μg and formoterol fumarate 6 μg (CHF 1535) was non-inferior to the free combination at the same dose in pulmonary function over the 12-h post-dose period in asthmatic children, with trend towards a dose-related response.",2021,"CHF1535 was non-inferior to free combination [adjusted mean difference (95% CI) 0.004 L (- 0.050, 0.041] with lower confidence limit greater than the limit set at 0.1 L. FEV 1 AUC 0-12h of each CHF1535 dose vs placebo were 0.037 L (p = 0.160), 0.119 L (p < 0.001), and 0.094 (p < 0.001) for 50/6, 100/12, and 200/24, respectively.","['pediatric patients', 'asthmatic children', '56 asthmatic children aged ≥ 5 and < 12 years']","['inhaled corticosteroids and long-acting β 2 - agonists', 'beclometasone dipropionate (BDP) 50 μg and formoterol fumarate (FF', 'placebo', 'new beclometasone dipropionate plus formoterol fumarate formulation', 'CHF1535', 'AeroChamber Plus™ spacer device', 'beclomethasone dipropionate 50 μg and formoterol fumarate', '•Inhaled pressurized metered-dose solutions (pMDI']","['Adverse events, electrocardiogram, and vital signs', 'forced expiratory volume during the first second (FEV 1 ) area under the curve corrected by time']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0004906', 'cui_str': 'Beclomethasone dipropionate'}, {'cui': 'C0771469', 'cui_str': 'Formoterol fumarate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0221874', 'cui_str': 'Spacer'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",56.0,0.651538,"CHF1535 was non-inferior to free combination [adjusted mean difference (95% CI) 0.004 L (- 0.050, 0.041] with lower confidence limit greater than the limit set at 0.1 L. FEV 1 AUC 0-12h of each CHF1535 dose vs placebo were 0.037 L (p = 0.160), 0.119 L (p < 0.001), and 0.094 (p < 0.001) for 50/6, 100/12, and 200/24, respectively.","[{'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Pohunek', 'Affiliation': 'Paediatric Department, University Hospital Motol, V Uvalu 84, 150 06, Praha, Czech Republic. petr.pohunek@LFMotol.cuni.cz.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Varoli', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici S.p.A., Via Palermo 26/A, 43122, Parma, Italy.'}, {'ForeName': 'Yuriy', 'Initials': 'Y', 'LastName': 'Reznichenko', 'Affiliation': 'Pulmonology Department of Community Institution ""Zaporizhzhya Regional Clinical Child Hospital"" of Zaporizhzhya Regional Council, Zaporizhzhya State Medical University, 70 Lenina str, Zaporizhzhya, 69063, Ukraine.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Mokia-Serbina', 'Affiliation': 'City Clinical Hospital № 8, 55, 23rd Lyutogo str., Kryvyi Rog, Ukraine.'}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'Brzostek', 'Affiliation': 'Poradnia Alergologiczna, ZOZ Debica, ul., Krakowska 91, 39-200, Debica, Poland.'}, {'ForeName': 'Viktoriya', 'Initials': 'V', 'LastName': 'Kostromina', 'Affiliation': 'Department of Child Pulmonology and Allergology, State Institution ""National Institute of Physiatry and Pulmonology n.a. F.G. Yanovskyy of AMS of Ukraine"", 10, Amosova str., Kyiv, 03680, Ukraine.'}, {'ForeName': 'Mykola', 'Initials': 'M', 'LastName': 'Kaladze', 'Affiliation': '1st City Children Clinical Association of Simferopol City, Department of Pulmonology, Simferopol, Department of Pediatry with Physiotherapy Course of Faculty of Postgraduate Education, State Institution ""Crimean State Medical University n.a. S.I. Georgiyivskiy"", 31, K. Libknehta, Simferopol, Crimea, Russia.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Muraro', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici S.p.A., Via Palermo 26/A, 43122, Parma, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Carzana', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici S.p.A., Via Palermo 26/A, 43122, Parma, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Armani', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici S.p.A., Via Palermo 26/A, 43122, Parma, Italy.'}, {'ForeName': 'Jadwiga', 'Initials': 'J', 'LastName': 'Kaczmarek', 'Affiliation': 'Outpatient Clinic of Allergology, Kopcinskiego Str 22, 90-153, Lodz, Poland.'}]",European journal of pediatrics,['10.1007/s00431-020-03888-x'] 1801,33386748,The persistent pelvic pain study: Factors that influence outcomes in women referred to a public hospital with chronic pelvic pain - A study protocol.,"BACKGROUND Persistent pelvic pain affects between 10-20% of women with a significant impact on their physical and mental health, sexual relationships, families and society. Estimates of the cost to women and the community is over $9 billion/annum. Although endometriosis is considered a leading cause of pelvic pain, no symptoms reliably allow the identification of those with and without endometriosis. Furthermore, the significance of mild endometriosis is now debated. The optimal clinical approach for pelvic pain and endometriosis remains unclear, with increasing evidence of other contributing factors such as central sensitisation. Studies to date have significant limitations due to their sample size, relatively short follow-up, and inclusion of only women with laparoscopically identified endometriosis. AIMS To undertake a real-world study of women referred with pain to gynaecology outpatients of a women's hospital and explore factors influencing three-year outcomes. MATERIALS AND METHODS Five hundred women will be randomised to one of two gynaecology units. The units will provide routine clinical care but their approaches to management of women with pelvic pain and endometriosis differ: one with skilled endoscopic gynaecologists has greater emphasis on surgery, the other, gynaecologists have more medical expertise in managing pain and menstrual problems. Participants will complete six-monthly questionnaires regarding pain and quality of life for three years. This information will not be available to clinicians. Their medical care will be followed from their medical records. The cost of outpatient care and admissions will be calculated. Data will be analysed using STATA software with appropriate post hoc tests. Australian and New Zealand Clinical Trials Registry (ANZCTR:ACTRN12616000150448).",2021,"Although endometriosis is considered a leading cause of pelvic pain, no symptoms reliably allow the identification of those with and without endometriosis.","['Five hundred women', ""women referred with pain to gynaecology outpatients of a women's hospital and explore factors influencing three-year outcomes"", 'women referred to a public hospital with chronic pelvic pain - A study protocol']","['skilled endoscopic gynaecologists', 'ANZCTR']",['pain and quality of life'],"[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0237419', 'cui_str': 'Gynecologist'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",500.0,0.148592,"Although endometriosis is considered a leading cause of pelvic pain, no symptoms reliably allow the identification of those with and without endometriosis.","[{'ForeName': 'Samantha S', 'Initials': 'SS', 'LastName': 'Mooney', 'Affiliation': 'Endosurgery Department, Mercy Hospital for Women, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sonia R', 'Initials': 'SR', 'LastName': 'Grover', 'Affiliation': 'Plenty Gynaecology Unit, Mercy Hospital for Women, Melbourne, Victoria, Australia.'}]",The Australian & New Zealand journal of obstetrics & gynaecology,['10.1111/ajo.13289'] 1802,33387486,Phase II Investigation of the Efficacy of Antimycobacterial Therapy in Chronic Pulmonary Sarcoidosis.,"BACKGROUND A Phase I, single-center investigation found that 8 weeks of antimycobacterial therapy improved sarcoidosis FVC. Safety and efficacy assessments have not been performed in a multicenter cohort. RESEARCH QUESTION The objective of this study was to determine the safety and efficacy of antimycobacterial therapy on the physiological and immunologic end points of sarcoidosis. STUDY DESIGN AND METHODS In a double-blind, placebo-controlled, multicenter investigation, patients with pulmonary sarcoidosis were randomly assigned to receive 16 weeks of concomitant levofloxacin, ethambutol, azithromycin, and rifabutin (CLEAR) or matching placebo to investigate the effect on FVC. The primary outcome was a comparison of change in percentage of predicted FVC among patients randomized to receive CLEAR or placebo in addition to their baseline immunosuppressive regimen. Secondary outcomes included 6-min walk distance (6MWD), St. George's Respiratory Questionnaire (SGRQ) score, adverse events, and decrease in mycobacterial early secreted antigenic target of 6 kDa (ESAT-6) immune responses. RESULTS The intention-to-treat analysis revealed no significant differences in change in FVC among the 49 patients randomized to receive CLEAR (1.1% decrease) compared with the 48 randomized to receive placebo (0.02% increase) (P = .64). Physiological parameters such as the change in 6MWD were likewise similar (P = .91); change in SGRQ favored placebo (-8.0 for placebo vs -1.5 for CLEAR; P = .028). The per-protocol analysis revealed no significant change in FVC at 16 weeks between CLEAR and placebo. There was no significant change in 6MWD (36.4 m vs 6.3 m; P = .24) or SGRQ (-2.3 vs -7.0; P = .14). A decline in ESAT-6 immune responses at 16 weeks was noted among CLEAR-treated patients (P = .0003) but not patients receiving placebo (P = .24). INTERPRETATION Despite a significant decline in ESAT-6 immune responses, a 16-week CLEAR regimen provided no physiological benefit in FVC or 6MWD among patients with sarcoidosis.",2020,"There was no significant change in 6MWD (36.4 meters vs 6.3 meters, p=0.24) or SGRQ (","['and Methods', 'pulmonary sarcoidosis patients', 'Chronic Pulmonary Sarcoidosis']","['placebo', 'anti-mycobacterial therapy', 'concomitant Levofloxacin, Ethambutol, Azithromycin and Rifabutin (CLEAR) or matching placebo', 'Antimycobacterial therapy']","['sarcoidosis physiologic and immunologic endpoints', 'change of FVC', '6MWD', 'sarcoidosis forced vital capacity (FVC', 'SGRQ', 'safety and efficacy', ""Six-minute Walk Distance (6MWD), Saint George's Respiratory Questionnaire (SGRQ), adverse events, and decrease in mycobacterial ESAT-6 immune responses"", 'FVC', 'Safety and efficacy assessments', 'ESAT-6 immune responses', 'comparison of change in percent of predicted FVC']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0036205', 'cui_str': 'Pulmonary sarcoidosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0014964', 'cui_str': 'Ethambutol'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0140575', 'cui_str': 'Rifabutin'}, {'cui': 'C0360390', 'cui_str': 'Antimycobacterial-containing product'}]","[{'cui': 'C0036202', 'cui_str': 'Sarcoidosis'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0152036', 'cui_str': 'Immunology'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0242823', 'cui_str': 'Saints'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",49.0,0.571689,"There was no significant change in 6MWD (36.4 meters vs 6.3 meters, p=0.24) or SGRQ (","[{'ForeName': 'Wonder P', 'Initials': 'WP', 'LastName': 'Drake', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN; Department of Pathology, Microbiology, and Immunology, Vanderbilt University School of Medicine, Nashville, TN. Electronic address: wonder.drake@vanderbilt.edu.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Culver', 'Affiliation': 'Department of Pulmonary Medicine, Respiratory Institute, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Baughman', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of Cincinnati Medical Center, Cincinnati, OH.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Judson', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Albany Medical College, Albany, NY.'}, {'ForeName': 'Elliott D', 'Initials': 'ED', 'LastName': 'Crouser', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, The Ohio State University Wexner Medical Center, Columbus, OH.'}, {'ForeName': 'W Ennis', 'Initials': 'WE', 'LastName': 'James', 'Affiliation': 'Division of Pulmonary and Critical Care, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Ayers', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN.'}, {'ForeName': 'Tan', 'Initials': 'T', 'LastName': 'Ding', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN.'}, {'ForeName': 'Kenny', 'Initials': 'K', 'LastName': 'Abel', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN.'}, {'ForeName': 'Abena', 'Initials': 'A', 'LastName': 'Green', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Kerrigan', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Sesay', 'Affiliation': 'Division of Pulmonary and Critical Care, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Gordon R', 'Initials': 'GR', 'LastName': 'Bernard', 'Affiliation': 'Division of Pulmonary and Critical Care, Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN.'}]",Chest,['10.1016/j.chest.2020.12.027'] 1803,33385632,"The impact of online brain training exercises on experiences of depression, anxiety and emotional wellbeing in a twin sample.","This study assessed the effectiveness of cognitive and emotional brain training and transfer effects to wellbeing and depression and anxiety symptoms. 352 healthy adult twins were randomised to a training group where they were asked to play brain training games over a 30-day period, or a waitlist control group. This study focused on the impact of the brain training on explicit and implicit emotional cognition, and analysed effects using both Intention-To-Treat (ITT) and Per-Protocol (PP) approaches. Both analyses revealed significant training effects for improvement in the explicit identification of fear expressions (ITT: p < 0.001, d = 0.33; PP training 3 h+: p < 0.001, d = 0.55), and a reduction in implicit bias for anger expressions amongst males (ITT: p < 0.001, d = 0.94; PP training 3 h+: p = 0.04, d = 0.90). Female participants also showed improvements in implicit bias for happy expressions (ITT: p = 0.003, d = 0.34; PP training 3 h+: p = 0.03, d = 0.47). Improvements resulting from training in emotional cognition did not directly improve wellbeing, depression or anxiety symptoms. Regression modelling also suggested training improvements in emotional cognition yielded no indirect transfer effects for the mental health and wellbeing measures. The results suggest brain training in healthy populations has potential for improving emotional cognition, but the subsequent impact on improving wellbeing and mental health symptoms is still equivocal.",2021,"Female participants also showed improvements in implicit bias for happy expressions (ITT: p = 0.003, d = 0.34; PP training 3 h+: p = 0.03, d = 0.47).","['in a twin sample', 'Female participants', 'healthy populations', '352 healthy adult twins']","['online brain training exercises', 'Intention-To-Treat (ITT) and Per-Protocol (PP) approaches', 'play brain training games over a 30-day period, or a waitlist control group', 'cognitive and emotional brain training', 'brain training']","['wellbeing, depression or anxiety symptoms', 'implicit bias for happy expressions', 'wellbeing and depression and anxiety symptoms', 'explicit identification of fear expressions', 'implicit bias for anger expressions', 'explicit and implicit emotional cognition', 'experiences of depression, anxiety and emotional wellbeing']","[{'cui': 'C0041427', 'cui_str': 'Twin sibling'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",352.0,0.0339723,"Female participants also showed improvements in implicit bias for happy expressions (ITT: p = 0.003, d = 0.34; PP training 3 h+: p = 0.03, d = 0.47).","[{'ForeName': 'Kylie M', 'Initials': 'KM', 'LastName': 'Routledge', 'Affiliation': 'The Brain Dynamics Centre, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, 2145, Australia. Electronic address: kylie.routledge@sydney.edu.au.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Williams', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine, Stanford University, Stanford, CA, 94305-5717, United States. Electronic address: leawilliams@stanford.edu.'}, {'ForeName': 'Anthony W F', 'Initials': 'AWF', 'LastName': 'Harris', 'Affiliation': 'The Brain Dynamics Centre, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, 2145, Australia; Specialty of Psychiatry, Sydney Medical School, University of Sydney, NSW, 2006, Australia. Electronic address: anthony.harris@sydney.edu.au.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Schofield', 'Affiliation': 'Neuroscience Research Australia, Randwick, NSW, 2031, Australia; School of Medical Sciences, University of New South Wales, Sydney, NSW, 2052, Australia. Electronic address: p.schofield@neura.edu.au.'}, {'ForeName': 'Justine M', 'Initials': 'JM', 'LastName': 'Gatt', 'Affiliation': 'Neuroscience Research Australia, Randwick, NSW, 2031, Australia; School of Psychology, University of New South Wales, Sydney, NSW, 2052, Australia. Electronic address: j.gatt@neura.edu.au.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.12.054'] 1804,33385624,Application of ultra-low-dose CT in 3D printing of distal radial fractures.,"PURPOSE To explore the effect of ultra-low-dose computed tomography (CT) on three-dimensional (3D) printing models and the diagnosis of wrist fractures. METHOD This study enrolled 76 patients with distal radial fractures (DRFs). All patients underwent 320-row detector CT and were divided randomly into two groups. In Group A, 38 patients were scanned with the standard-dose protocol using a tube voltage of 120 kV and current of 100 mA. In Group B, 38 patients were scanned with the ultra-low-dose protocol using a tube voltage of 80 kV and current of 10 mA. For objective image quality assessment, the noise, CT number, signal-to-noise ratio (SNR), and contrast-to-noise ratio (CNR) were measured. Subjectively, two experienced orthopaedic surgeons blinded to the scan parameters evaluated the clarity of the 3D printing model and fracture line using a 3-point scale (the diagnosis was considered acceptable with scores ≥2). The mean radiation dose was calculated. The diagnostic performances for the fractures between the two groups were compared. RESULTS The effective radiation dose was significantly reduced by 97.1 % in Group B, compared to Group A (0.28 ± 0.05vs. 9.75 ± 2.23 μSv, respectively). Quantitative objective image quality parameters (e.g., CNR, SNR, and CT numbers) were higher in the standard-dose group (p < 0.001). However, there was no difference in subjective scoring of the 3D printing model. Although the fracture line score was higher in Group A (2.92±0.27 vs. 2.16 ± 0.37; p < 0.001), the diagnostic performance of the two groups was consistent (all scores ≥2). There were no statistically significant differences in the sensitivity, specificity or accuracy between standard-dose group and ultra-low-dose group. CONCLUSIONS The ultra-low-dose protocol effectively reduced the radiation dose by 97.1 %, while maintaining the image quality for diagnosis of DRFs. Therefore, this protocol can meet the needs of 3D printing models for preoperative assessments.",2021,"Although the fracture line score was higher in Group A (2.92±0.27 vs. 2.16 ± 0.37; p < 0.001), the diagnostic performance of the two groups was consistent (all scores ≥2).","['3D printing of distal radial fractures', '76 patients with distal radial fractures (DRFs']","['ultra-low-dose CT', '320-row detector CT', 'ultra-low-dose computed tomography (CT']","['Quantitative objective image quality parameters (e.g., CNR, SNR, and CT numbers', 'diagnostic performances', 'sensitivity, specificity or accuracy', 'effective radiation dose', 'mean radiation dose', 'clarity of the 3D printing model and fracture line using a 3-point scale', 'diagnostic performance', 'noise, CT number, signal-to-noise ratio (SNR), and contrast-to-noise ratio (CNR', 'fracture line score']","[{'cui': 'C3849992', 'cui_str': 'Three-Dimensional Printing'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0034628', 'cui_str': 'Fracture of radius'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C4517711', 'cui_str': '320'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property)'}, {'cui': 'C3849992', 'cui_str': 'Three-Dimensional Printing'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",76.0,0.0283433,"Although the fracture line score was higher in Group A (2.92±0.27 vs. 2.16 ± 0.37; p < 0.001), the diagnostic performance of the two groups was consistent (all scores ≥2).","[{'ForeName': 'Mengqiang', 'Initials': 'M', 'LastName': 'Xiao', 'Affiliation': 'Department of Radiology, Zhuhai Hospital, Guangdong Hospital of Traditional Chinese Medicine, 53 Jingle Road, Zhuhai City, Guangdong Province, China. Electronic address: xmqzhuhai@163.com.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, Zhuhai Hospital, Guangdong Hospital of Traditional Chinese Medicine, 53 Jingle Road, Zhuhai City, Guangdong Province, China. Electronic address: zxx958740675@163.com.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Lei', 'Affiliation': 'Department of Radiology, Zhuhai Hospital, Guangdong Hospital of Traditional Chinese Medicine, 53 Jingle Road, Zhuhai City, Guangdong Province, China. Electronic address: 37060800@qq.com.'}, {'ForeName': 'Xiaolu', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Radiology, Zhuhai Hospital, Guangdong Hospital of Traditional Chinese Medicine, 53 Jingle Road, Zhuhai City, Guangdong Province, China. Electronic address: 502435924@qq.com.'}, {'ForeName': 'Qingshan', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Zhuhai Hospital, Guangdong Hospital of Traditional Chinese Medicine, 53 Jingle Road, Zhuhai City, Guangdong Province, China. Electronic address: WQS1383@163.com.'}, {'ForeName': 'Yanxia', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, Zhuhai Hospital, Guangdong Hospital of Traditional Chinese Medicine, 53 Jingle Road, Zhuhai City, Guangdong Province, China. Electronic address: 1643622092@qq.com.'}, {'ForeName': 'Jingzhi', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Department of Radiology, Zhuhai Hospital, Guangdong Hospital of Traditional Chinese Medicine, 53 Jingle Road, Zhuhai City, Guangdong Province, China. Electronic address: 419393897@qq.com.'}, {'ForeName': 'Rulin', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'Radiology Group, Canon Medical Systems(China) Co., LTD, Rm 2906, R&F Centre, No.10 Huaxia Road, Guangzhou City, Guangdong Province, China. Electronic address: colin_xu@163.com.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, Zhuhai Hospital, Guangdong Hospital of Traditional Chinese Medicine, 53 Jingle Road, Zhuhai City, Guangdong Province, China. Electronic address: junesums@163.com.'}]",European journal of radiology,['10.1016/j.ejrad.2020.109488'] 1805,33383492,The transcranial direct current stimulation over prefrontal cortex combined with the cognitive training reduced the cue-induced craving in female individuals with methamphetamine use disorder: A randomized controlled trial.,"BACKGROUND Craving and cognitive deficits are potential treatment targets for methamphetamine use disorder (MUD). Previous studies implied that transcranial direct current stimulation (tDCS) and cognitive training respectively improve these symptoms, but the combined effect is unknown. In this study, we investigated the combined effects of tDCS over dorsolateral prefrontal cortex (DLPFC) and computerized cognitive addiction therapy (CCAT) on cue-induced craving and cognitive functions among female individuals with MUD. METHODS Seventy-five patients with MUD were randomly assigned to three groups: CCAT + tDCS group, CCAT + sham tDCS group and the control group. The former two groups received 20 sessions of cognitive training combined 1.5 mA active/sham tDCS over DLPFC (20min/session, 5times/week), while the control group received usual care which includes routine medical care, health education, physical exercises and psychological support related to relapse prevention. The cue-induced craving and cognitive functions were tested at the baseline, the end of 2nd week and 4th week. RESULTS The CCAT + tDCS group showed a significant reduction in cue-induced craving after 4-week intervention. Moreover, the craving score of the real CCAT + tDCS group was significantly lower than that of the CCAT + sham tDCS group and that of the control group at the end of 4th week. A significant improvement in accuracy of TWOB task was only observed in the CCAT + tDCS group at the end of 4th week when compared to baseline. Unexpectedly, participants who received CCAT plus active or sham tDCS did not change their discounting, whereas those in the control group performed more impulsively over time. CONCLUSIONS The study found that the intervention of tDCS over DLPFC combined with CCAT may have potential benefit in improving treatment outcome in patients with MUD. More research is needed to explore the underlying mechanism.",2021,A significant improvement in accuracy of TWOB task was only observed in the CCAT + tDCS group at the end of 4th week when compared to baseline.,"['female individuals with methamphetamine use disorder', 'Seventy-five patients with MUD', 'patients with MUD', 'female individuals with MUD']","['CCAT', 'transcranial direct current stimulation over prefrontal cortex combined with the cognitive training', 'cognitive training combined 1.5\xa0mA active/sham tDCS over DLPFC (20min/session, 5times/week), while the control group received usual care which includes routine medical care, health education, physical exercises and psychological support related to relapse prevention', 'tDCS over dorsolateral prefrontal cortex (DLPFC) and computerized cognitive addiction therapy (CCAT', 'CCAT\xa0+\xa0sham tDCS', 'CCAT\xa0+\xa0tDCS group, CCAT\xa0+\xa0sham tDCS', 'transcranial direct current stimulation (tDCS) and cognitive training', 'CCAT plus active or sham tDCS']","['craving score', 'cue-induced craving and cognitive functions', 'accuracy of TWOB task', 'cue-induced craving']","[{'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0679867', 'cui_str': 'Relapse prevention'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",75.0,0.0257838,A significant improvement in accuracy of TWOB task was only observed in the CCAT + tDCS group at the end of 4th week when compared to baseline.,"[{'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, 600 South Wanping Road, Shanghai, 200030, China.'}, {'ForeName': 'Xinni', 'Initials': 'X', 'LastName': 'Ding', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, 600 South Wanping Road, Shanghai, 200030, China.'}, {'ForeName': 'Liyu', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, 600 South Wanping Road, Shanghai, 200030, China.'}, {'ForeName': 'Tianzhen', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, 600 South Wanping Road, Shanghai, 200030, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, 600 South Wanping Road, Shanghai, 200030, China.'}, {'ForeName': 'Xiaotong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, 600 South Wanping Road, Shanghai, 200030, China.'}, {'ForeName': 'Yujian', 'Initials': 'Y', 'LastName': 'Ye', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, 600 South Wanping Road, Shanghai, 200030, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Shi', 'Affiliation': 'Shanghai Female Drug Rehabilitation Center, 7501 Wai Qing Song Road, Shanghai, 201701, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Ji', 'Affiliation': 'Shanghai Female Drug Rehabilitation Center, 7501 Wai Qing Song Road, Shanghai, 201701, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, 600 South Wanping Road, Shanghai, 200030, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China; Institute of Psychological and Behavioral Science, Shanghai Jiao Tong University, Shanghai, China; CAS Center for Excellence in Brain Science and Intelligence Technology (CEBSIT), Chinese Academy of Sciences, Shanghai, China. Electronic address: drminzhao@smhc.org.cn.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhong', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, 600 South Wanping Road, Shanghai, 200030, China. Electronic address: winco917@hotmail.com.'}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, 600 South Wanping Road, Shanghai, 200030, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China. Electronic address: dragonjhf@hotmail.com.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.12.056'] 1806,33389823,"Re: ""Does tamsulosin or mirabegron improve ureteral stent-related symptoms? A prospective placebo-controlled study"".",,2021,,[],"['tamsulosin', 'placebo']",[],[],"[{'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0313819,,"[{'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Sharma', 'Affiliation': 'Department of Urology, PGIMER, Chandigarh, India.'}]",Lower urinary tract symptoms,['10.1111/luts.12340'] 1807,33395182,The Effect of Low-Volume Preseason Plyometric Training on Force-Velocity Profiles in Semiprofessional Rugby Union Players.,"ABSTRACT Watkins, CM, Gill, ND, Maunder, E, Downes, P, Young, JD, McGuigan, MR, and Storey, AG. The effect of low-volume preseason plyometric training on force-velocity profiles in semiprofessional rugby union players. J Strength Cond Res 35(3): 604-615, 2021-Rugby union is a physically demanding and complex team sport requiring athletes across all positions to express speed and acceleration. Plyometrics can effectively improve speed profiles by enhancing both force- and velocity-(FV) characteristics; however, the optimal dose and exercise direction for trained athletes is still relatively unknown. Therefore, the aim of this investigation was to determine the efficacy of a low-dose, directionally specific plyometric training program for improving speed profiles in semiprofessional rugby players. Players were randomly allocated to one of 2 plyometric training groups that performed low-volume (40-60 ground contacts per session) plyometrics twice weekly, or a control group that did not participate in any plyometric training. The 2 training groups underwent reverse back-to-back three-week vertically and horizontally focused plyometric training programs, with a 12-day washout. Body composition, aerobic capacity, and sprint performance (10-, 20-, 30-m split time, horizontal FV profile) were measured. During the intervention, HV-1 (horizontal/vertical training group 1) improved sprint performance (n = 12; ∆30 m = -0.020 seconds; p = 0.038), VH-2 (vertical/horizontal training group 2) maintained sprint performance (n = 8; ∆30 m = +0.049 seconds; p = 0.377), and the control group progressively declined in sprint performance (n = 12; ∆30 m = +0.071; p = 0.019). In addition, vertical plyometrics may preferentially benefit secondary acceleration (∆10-20 m split time: -0.01 seconds; p = 0.03) and many force-oriented FV profile characteristics. Correlational analyses (r2 = -0.568 to 0.515) showed sprint improvements were hindered in athletes with lower initial aerobic fitness, suggesting accumulated fatigue may have limited the magnitude of adaptation. Therefore, including low-volume plyometric training may be beneficial for improving sprint profiles or attenuating decrements realized during periods of high-volume sport-specific training.",2021,"During the intervention, HV-1 (horizontal/vertical training group 1) improved sprint performance (n = 12; [INCREMENT]30 m = -0.020 seconds; p = 0.038), VH-2 (vertical/horizontal training group 2) maintained sprint performance (n = 8; [INCREMENT]30 m = +0.049 seconds; p = 0.377), and the control group progressively declined in sprint performance (n = 12; [INCREMENT]30 m = +0.071; p = 0.019).","['semiprofessional rugby union players', ' 000-000, 2020-Rugby union is a physically demanding and complex team sport requiring athletes across all positions to express speed and acceleration', 'Semiprofessional Rugby Union Players', 'semiprofessional rugby players']","['J Strength Cond Res XX(X', 'reverse back-to-back three-week vertically and horizontally focused plyometric training programs', 'Low-Volume Preseason Plyometric Training', 'directionally specific plyometric training program', 'low-volume preseason plyometric training', 'plyometric training groups that performed low-volume (40-60 ground contacts per session) plyometrics twice weekly, or a control group that did not participate in any plyometric training']","['Body composition, aerobic capacity, and sprint performance ', 'sprint performance', 'force-velocity profiles']","[{'cui': 'C0035945', 'cui_str': 'Rugby'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}]","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C4082109', 'cui_str': 'Three weeks'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}]",,0.0230405,"During the intervention, HV-1 (horizontal/vertical training group 1) improved sprint performance (n = 12; [INCREMENT]30 m = -0.020 seconds; p = 0.038), VH-2 (vertical/horizontal training group 2) maintained sprint performance (n = 8; [INCREMENT]30 m = +0.049 seconds; p = 0.377), and the control group progressively declined in sprint performance (n = 12; [INCREMENT]30 m = +0.071; p = 0.019).","[{'ForeName': 'Casey M', 'Initials': 'CM', 'LastName': 'Watkins', 'Affiliation': 'Sports Performance Research Institute New Zealand, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Nicholas D', 'Initials': 'ND', 'LastName': 'Gill', 'Affiliation': 'Health, Sport and Human Performance, University of Waikato, Tauranga, New Zealand; and.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Maunder', 'Affiliation': 'Sports Performance Research Institute New Zealand, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Downes', 'Affiliation': 'Auckland Rugby Union, Auckland, New Zealand.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Young', 'Affiliation': 'Auckland Rugby Union, Auckland, New Zealand.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'McGuigan', 'Affiliation': 'Sports Performance Research Institute New Zealand, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Adam G', 'Initials': 'AG', 'LastName': 'Storey', 'Affiliation': 'Sports Performance Research Institute New Zealand, Auckland University of Technology, Auckland, New Zealand.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003917'] 1808,33399273,Three-year outcomes of peripheral blood mononuclear cells vs purified CD34 + cells in the treatment of angiitis-induced no-option critical limb ischemia and a cost-effectiveness assessment: A randomized single-blinded noninferiority trial.,"For patients with angiitis-induced critical limb ischemia (AICLI), cell transplantation, such as purified CD34 + cells (PCCs) and peripheral blood mononuclear cells (PBMNCs), is gradually being used as a promising treatment. This was the first randomized single-blinded noninferiority trial (number: NCT02089828) specifically designed to evaluate the therapeutic efficacies of the transplantation of PCCs vs those of PBMNCs for the treatment of AICLI. We aimed to compare the mid-term safety and efficacy between the two groups and determine their respective advantages. From April 2014 to September 2019, 50 patients with AICLI were equally allocated to the two groups, except for 1 lost patient, 1 amputee, and 1 patient who died of heart disease. The other 47 patients completed the 36-month follow-up. The endpoints were as follows: major amputation-free survival and total amputation-free survival at 6 months, which were 96.0% and 84.0% in the PBMNCs group and 96.0% and 72.0% in the PCCs group, respectively. These rates remained stable at 12, 24, and 36 months. The PCCs group had a significant higher probability of rest pain relief than the PBMNCs group, whereas earlier significant improvements in the Rutherford classification were observed in the PBMNCs group. Accordingly, PCCs would be preferred for patients with significant pain, whereas PBMNCs may be a good option for patients with two or more critically ischemic limbs. Concerning cost-effectiveness, PCCs are not more cost-effective than PBMNCs. These outcomes require verification from long-term trials involving larger numbers of patients.",2021,"The PCCs group had a significant higher probability of rest pain relief than the PBMNCs group, whereas earlier significant improvements in the Rutherford classification were observed in the PBMNCs group.","['47 patients completed the 36-month follow-up', 'patients with angiitis-induced critical limb ischemia (AICLI', 'From April 2014 to September 2019, 50 patients with AICLI']",['peripheral blood mononuclear cells vs purified CD34 + cells'],"['major amputation-free survival and total amputation-free survival', 'probability of rest pain relief']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1142264', 'cui_str': 'Critical limb ischemia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0882849', 'cui_str': 'Cell positive for CD34 antigen'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}]",50.0,0.0643145,"The PCCs group had a significant higher probability of rest pain relief than the PBMNCs group, whereas earlier significant improvements in the Rutherford classification were observed in the PBMNCs group.","[{'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Department of Vascular Surgery of Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Tianyue', 'Initials': 'T', 'LastName': 'Pan', 'Affiliation': ""Department of Vascular Surgery of Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': ""Department of Vascular Surgery of Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Fang', 'Affiliation': ""Department of Vascular Surgery of Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Yifan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Vascular Surgery of Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Xiaolang', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': ""Department of Vascular Surgery of Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': ""Department of Vascular Surgery of Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Wei', 'Affiliation': ""Department of Hematology of Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Shiyang', 'Initials': 'S', 'LastName': 'Gu', 'Affiliation': ""Department of Hematology of Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': ""Department of Hematology of Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Fu', 'Affiliation': ""Department of Vascular Surgery of Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Zhihui', 'Initials': 'Z', 'LastName': 'Dong', 'Affiliation': ""Department of Vascular Surgery of Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.""}]",Stem cells translational medicine,['10.1002/sctm.20-0033'] 1809,33398627,"Role of Gastrointestinal Hormones as a Predictive Factor for Long-Term Diabetes Remission: Randomized Trial Comparing Metabolic Gastric Bypass, Sleeve Gastrectomy, and Greater Curvature Plication.","PURPOSE Long-term studies comparing the mechanisms of different bariatric techniques for T2DM remission are scarce. We aimed to compare type 2 diabetes (T2DM) remission after a gastric bypass with a 200-cm biliopancreatic limb (mRYGB), sleeve gastrectomy (SG), and greater curvature plication (GCP), and to assess if the initial secretion of gastrointestinal hormones may predict metabolic outcomes at 5 years. MATERIAL AND METHODS Forty-five patients with mean BMI of 39.4(1.9)kg/m 2 and T2DM with HbA 1c of 7.7(1.9)% were randomized to mRYGB, SG, or GCP. Anthropometric and biochemical parameters, fasting concentrations of PYY, ghrelin, glucagon, and AUC of GLP-1 after SMT were determined prior to and at months 1 and 12 after surgery. At 5-year follow-up, anthropometrical and biochemical parameters were determined. RESULTS Total weight loss percentage (TWL%) at year 1 and GLP-1 AUC at months 1 and 12 were higher in the mRYGB than in the SG and GCP. TWL% remained greater at 5 years in mRYGB group - 27.32 (7.8) vs. SG - 18.00 (10.6) and GCP - 14.83 (7.8), p = 0.001. At 5 years, complete T2DM remission was observed in 46.7% after mRYGB vs. 20.0% after SG and 6.6% after GCP, p < 0.001. In the multivariate analysis, shorter T2DM duration (OR 0.186), p = 0.008, and the GLP-1 AUC at 1 month (OR 7.229), p = 0.023, were prognostic factors for complete T2DM remission at 5-year follow-up. CONCLUSIONS Long-term T2DM remission is mostly achieved with hypoabsortive techniques such as mRYGB. Increased secretion of GLP-1 after surgery and shorter disease duration were the main predictors of T2DM remission at 5 years.",2021,"In the multivariate analysis, shorter T2DM duration (OR 0.186), p = 0.008, and the GLP-1 AUC at 1 month (OR 7.229), p = 0.023, were prognostic factors for complete T2DM remission at 5-year follow-up. ","['Forty-five patients with mean', 'Long-Term Diabetes Remission']","['Metabolic Gastric Bypass, Sleeve Gastrectomy, and Greater Curvature Plication', 'gastric bypass with a 200-cm biliopancreatic limb (mRYGB), sleeve gastrectomy (SG), and greater curvature plication (GCP']","['Total weight loss percentage (TWL', 'complete T2DM remission', 'type 2 diabetes (T2DM) remission', 'Increased secretion of GLP-1', 'Anthropometric and biochemical parameters, fasting concentrations of PYY, ghrelin, glucagon, and AUC of GLP-1 after SMT', 'shorter T2DM duration', 'TWL']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]","[{'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0227223', 'cui_str': 'Structure of greater curvature of stomach'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",45.0,0.0271729,"In the multivariate analysis, shorter T2DM duration (OR 0.186), p = 0.008, and the GLP-1 AUC at 1 month (OR 7.229), p = 0.023, were prognostic factors for complete T2DM remission at 5-year follow-up. ","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Casajoana', 'Affiliation': ""Department of General and Gastrointestinal Surgery, Bariatric Surgery Unit, Bellvitge University Hospital-IDIBELL, Feixa Llarga s/n, L'Hospitalet de Llobregat, 08907, Barcelona, Spain.""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Guerrero-Pérez', 'Affiliation': ""Department of Endocrinology and Nutrition, Bellvitge University Hospital-IDIBELL, Feixa Llarga s/n, L'Hospitalet de Llobregat, 08907, Barcelona, Spain.""}, {'ForeName': 'Amador', 'Initials': 'A', 'LastName': 'García Ruiz de Gordejuela', 'Affiliation': ""Department of General Surgery, Endocrine, Bariatric and Metabolic Surgery Unit, Vall d'Hebron University Hospital, Ps Vall d'Hebron, 119-129, 08035, Barcelona, Spain.""}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Admella', 'Affiliation': ""Department of General and Gastrointestinal Surgery, Bariatric Surgery Unit, Bellvitge University Hospital-IDIBELL, Feixa Llarga s/n, L'Hospitalet de Llobregat, 08907, Barcelona, Spain.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Sorribas', 'Affiliation': ""Department of General and Gastrointestinal Surgery, Bariatric Surgery Unit, Bellvitge University Hospital-IDIBELL, Feixa Llarga s/n, L'Hospitalet de Llobregat, 08907, Barcelona, Spain.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Vidal-Alabró', 'Affiliation': ""Bellvitge Biomedical Research Institute-IDIBELL, Feixa Llarga s/n, L'Hospitalet de Llobregat, 08907, Barcelona, Spain.""}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Virgili', 'Affiliation': ""Department of Endocrinology and Nutrition, Bellvitge University Hospital-IDIBELL, Feixa Llarga s/n, L'Hospitalet de Llobregat, 08907, Barcelona, Spain.""}, {'ForeName': 'Rafael López', 'Initials': 'RL', 'LastName': 'Urdiales', 'Affiliation': ""Department of Endocrinology and Nutrition, Bellvitge University Hospital-IDIBELL, Feixa Llarga s/n, L'Hospitalet de Llobregat, 08907, Barcelona, Spain.""}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Montserrat', 'Affiliation': ""Department of Endocrinology and Nutrition, Bellvitge University Hospital-IDIBELL, Feixa Llarga s/n, L'Hospitalet de Llobregat, 08907, Barcelona, Spain.""}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Pérez-Maraver', 'Affiliation': ""Department of Endocrinology and Nutrition, Bellvitge University Hospital-IDIBELL, Feixa Llarga s/n, L'Hospitalet de Llobregat, 08907, Barcelona, Spain.""}, {'ForeName': 'Carme', 'Initials': 'C', 'LastName': 'Monasterio', 'Affiliation': ""Department of Pneumology, Sleep Unit, Bellvitge University Hospital-IDIBELL, Feixa Llarga s/n, L'Hospitalet de Llobregat, 08907, Barcelona, Spain.""}, {'ForeName': 'Neus', 'Initials': 'N', 'LastName': 'Salord', 'Affiliation': ""Department of Pneumology, Sleep Unit, Bellvitge University Hospital-IDIBELL, Feixa Llarga s/n, L'Hospitalet de Llobregat, 08907, Barcelona, Spain.""}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Pellitero', 'Affiliation': 'Department of Endocrinology and Nutrition and Health Sciences Research Institute, University Hospital Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Fernández-Veledo', 'Affiliation': ""Diabetes and Metabolic Associated Diseases Research Group, Hospital Universitari Joan XXIII-Institut d'Investigació Sanitària Pere Virgili, Tarragona, Spain.""}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Vendrell', 'Affiliation': ""Diabetes and Metabolic Associated Diseases Research Group, Hospital Universitari Joan XXIII-Institut d'Investigació Sanitària Pere Virgili, Tarragona, Spain.""}, {'ForeName': 'Jordi Pujol', 'Initials': 'JP', 'LastName': 'Gebelli', 'Affiliation': ""Department of General and Gastrointestinal Surgery, Bariatric Surgery Unit, Bellvitge University Hospital-IDIBELL, Feixa Llarga s/n, L'Hospitalet de Llobregat, 08907, Barcelona, Spain.""}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Vilarrasa', 'Affiliation': ""Department of Endocrinology and Nutrition, Bellvitge University Hospital-IDIBELL, Feixa Llarga s/n, L'Hospitalet de Llobregat, 08907, Barcelona, Spain. nuriavilarrasa@yahoo.es.""}]",Obesity surgery,['10.1007/s11695-020-05192-x'] 1810,33404504,Uptake of Proactively Offered Online and Telephone Support Services Targeting Multiple Health Risk Behaviors Among Vocational Education Students: Process Evaluation of a Cluster Randomized Controlled Trial.,"BACKGROUND A high proportion of vocational education students smoke tobacco, have inadequate nutrition (ie, low fruit and vegetable intake), drink alcohol at risky levels, or are physically inactive. The extent to which vocational education students will sign up for proactively offered online and telephone support services for multiple health risk behaviors is unknown. OBJECTIVE The aim of this study is to examine the uptake of proactively offered online and telephone support services for smoking, nutrition, alcohol consumption, and physical activity risk behaviors, individually and in combination, among vocational education students in the Technical and Further Education (TAFE) setting. The characteristics associated with the uptake of online or telephone services for smoking, nutrition, alcohol consumption, and physical activity risk behaviors were also examined. METHODS Vocational education students enrolled in a TAFE class in New South Wales, Australia, which ran for 6 months or more, were recruited to participate in a cluster randomized controlled trial from May 2018 to May 2019. In the intervention arm, participants who did not meet the Australian health guidelines for each of the smoking, nutrition, alcohol consumption, and physical activity risk behaviors were provided electronic feedback and proactively offered online and telephone support services. Uptake of support was measured by whether participants signed up for the online and telephone services they were offered. RESULTS Vocational education students (N=551; mean age 25.7 years, SD 11.1; 310/551, 56.3% male) were recruited into the intervention arm. Uptake of the proactive offer of either online or telephone services was 14.5% (59/406) for fruit and vegetables, 12.7% (29/228) for physical activity, 6.8% (13/191) for smoking, and 5.5% (18/327) for alcohol use. Uptake of any online or telephone service for at least two health behaviors was 5.8% (22/377). Participants who were employed (odds ratio [OR] 0.10, 95% CI 0.01-0.72) and reported not being anxious (OR 0.11, 95% CI 0.02-0.71) had smaller odds of signing up for online or telephone services for smoking, whereas participants who reported not being depressed had greater odds (OR 10.25, 95% CI 1.30-80.67). Participants who intended to change their physical activity in the next 30 days had greater odds (OR 4.01, 95% CI 1.33-12.07) of signing up for online or telephone services for physical activity. Employed participants had smaller odds (OR 0.18, 95% CI 0.06-0.56) of signing up for support services for at least two behaviors. CONCLUSIONS Although the uptake of proactively offered online and telephone support services is low, these rates appear to be higher than the self-initiated use of some of these services in the general population. Scaling up the proactive offer of online and telephone services may produce beneficial health outcomes. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry: ACTRN12618000723280; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375001.",2021,Uptake of any online or telephone service for at least two health behaviors was 5.8% (22/377).,"['Vocational education students (N=551; mean age 25.7 years, SD 11.1; 310/551, 56.3% male', 'Vocational education students enrolled in a TAFE class in New South Wales, Australia, which ran for 6 months or more, were recruited to participate in a cluster randomized controlled trial from May 2018 to May 2019', 'vocational education students in the Technical and Further Education (TAFE) setting', 'Vocational Education Students', 'Australian New Zealand Clinical Trials Registry']",['Telephone Support Services'],"['physical activity', 'uptake of online or telephone services for smoking, nutrition, alcohol consumption, and physical activity risk behaviors', 'smaller odds of signing up for online or telephone services for smoking']","[{'cui': 'C0042933', 'cui_str': 'Vocational schooling'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0578818', 'cui_str': 'In further education'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0220912', 'cui_str': 'signs'}]",,0.0927523,Uptake of any online or telephone service for at least two health behaviors was 5.8% (22/377).,"[{'ForeName': 'Prince', 'Initials': 'P', 'LastName': 'Atorkey', 'Affiliation': 'School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Paul', 'Affiliation': 'School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Billie', 'Initials': 'B', 'LastName': 'Bonevski', 'Affiliation': 'School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wiggers', 'Affiliation': 'School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Mitchell', 'Affiliation': 'School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Byrnes', 'Affiliation': 'School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lecathelinais', 'Affiliation': 'School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Tzelepis', 'Affiliation': 'School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Newcastle, Australia.'}]",Journal of medical Internet research,['10.2196/19737'] 1811,33409971,Effects of Resistance Training With or Without Protein Supplementation on Body Composition and Resting Energy Expenditure in Patients 2-7 Years PostRoux-en-Y Gastric Bypass: a Controlled Clinical Trial.,"BACKGROUND Resistance training (RT) and adequate protein intake are recommended as strategies to preserve fat-free mass (FFM) and resting metabolic demand after bariatric surgery. However, the effect of both interventions combined in the late postoperative period is unclear. This study investigated the effects of RT, isolated and combined with protein supplementation, on body composition and resting energy expenditure (REE) in the late postoperative period of Roux-en-Y gastric bypass (RYGB). METHODS This controlled trial involved patients who were 2-7 years postRYGB. Participants were partially matched on body mass index (BMI), age, sex, and years after surgery, and divided into four groups, placebo maltodextrin (control [CON]; n = 17), whey protein supplementation (PRO; n = 18), RT combined with placebo (RTP; n = 13), and RT combined with whey protein supplementation (RTP + PRO; n = 15)-considering the participants who completed the protocol. REE was measured by indirect calorimetry and body composition by multifrequency electrical bioimpedance. RESULTS Participant characteristics (40.3 ± 8.3 years old; average BMI 29.7 ± 5.3 kg/m 2 ; 88.9% females) were similar among groups. The RTP+PRO group showed an increase of 1.46 ± 1.02 kg in FFM and 0.91 ± 0.64 kg in skeletal muscle mass (SMM), which was greater than the equivalent values in the CON group (- 0.24 ± 1.64 kg, p = 0.006 and - 0.08 ± 0.96 kg, p = 0.008, respectively). There was no significant time-by-group interaction for absolute or relative REE. CONCLUSION Combined RT and adequate protein intake via supplementation can increase FFM and SMM in the late postoperative period without changing REE. These associated strategies were effective in improving muscle-related parameters and potentially in improving the patients' physical function.",2021,"There was no significant time-by-group interaction for absolute or relative REE. ","['Participants were partially matched on body mass index (BMI), age, sex, and years after surgery', 'Patients 2-7\xa0Years PostRoux-en-Y Gastric Bypass', 'patients who were 2-7\xa0years postRYGB']","['RT, isolated and combined with protein supplementation', 'Resistance training (RT) and adequate protein intake', 'Resistance Training With or Without Protein Supplementation', 'Roux-en-Y gastric bypass (RYGB', 'placebo maltodextrin (control [CON]; n\u2009=\u200917), whey protein supplementation (PRO; n\u2009=\u200918), RT combined with placebo (RTP; n\u2009=\u200913), and RT combined with whey protein supplementation (RTP\u2009+\u2009PRO; n\u2009=\u200915)-considering the participants who completed the protocol']","['FFM and SMM', 'REE', 'Body Composition and Resting Energy Expenditure', 'body composition and resting energy expenditure (REE']","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]",,0.0273807,"There was no significant time-by-group interaction for absolute or relative REE. ","[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Lamarca', 'Affiliation': 'Graduate Program in Human Nutrition, University of Brasília, 70910-900, Asa Norte, Brasília, Federal District, Brazil.'}, {'ForeName': 'Flávio Teixeira', 'Initials': 'FT', 'LastName': 'Vieira', 'Affiliation': 'Graduate Program in Human Nutrition, University of Brasília, 70910-900, Asa Norte, Brasília, Federal District, Brazil.'}, {'ForeName': 'Ricardo Moreno', 'Initials': 'RM', 'LastName': 'Lima', 'Affiliation': 'Graduate Program in Physical Education, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Eduardo Yoshio', 'Initials': 'EY', 'LastName': 'Nakano', 'Affiliation': 'Department of Statistics, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Teresa Helena Macedo', 'Initials': 'THM', 'LastName': 'da Costa', 'Affiliation': 'Graduate Program in Human Nutrition, University of Brasília, 70910-900, Asa Norte, Brasília, Federal District, Brazil.'}, {'ForeName': 'Nathalia', 'Initials': 'N', 'LastName': 'Pizato', 'Affiliation': 'Graduate Program in Human Nutrition, University of Brasília, 70910-900, Asa Norte, Brasília, Federal District, Brazil.'}, {'ForeName': 'Eliane Said', 'Initials': 'ES', 'LastName': 'Dutra', 'Affiliation': 'Graduate Program in Human Nutrition, University of Brasília, 70910-900, Asa Norte, Brasília, Federal District, Brazil.'}, {'ForeName': 'Kênia Mara Baiocchi', 'Initials': 'KMB', 'LastName': 'de Carvalho', 'Affiliation': 'Graduate Program in Human Nutrition, University of Brasília, 70910-900, Asa Norte, Brasília, Federal District, Brazil. kenia@unb.br.'}]",Obesity surgery,['10.1007/s11695-020-05172-1'] 1812,33408073,Circulating 27-hydroxycholesterol and Risk of Colorectal Adenomas and Serrated Polyps.,"The oxysterol 27-hydroxycholesterol (27-OHC) is an endogenous selective estrogen receptor modulator implicated in breast cancer etiology. It is unknown whether circulating 27-OHC is associated with colorectal neoplasia risk. Circulating 27-OHC was measured using LC/MS in fasting plasma collected at baseline from participants of the Vitamin D/Calcium Polyp Prevention Study, a completed randomized clinical trial. Participants were between 45 and 75 years old, recently diagnosed with ≥1 colorectal adenoma, and followed for new colorectal polyps during colonoscopic surveillance. Adjusted risk ratios (RR) with 95% confidence intervals (CI) of new colorectal polyps were estimated for quartiles of circulating 27-OHC using log-linear regression for repeated outcomes. Polyp phenotypes included any adenomas, advanced adenomas, hyperplastic polyps, and sessile serrated adenomas/polyps. Circulating 27-OHC was measured at baseline for 1,246 participants. Compared with participants with circulating 27-OHC below the first quartile (<138 ng/mL), those with circulating 27-OHC at or above the fourth quartile (≥201 ng/mL) had 24% higher risk of adenomas (RR, 1.24; 95% CI, 1.05-1.47) and 89% higher risk of advanced adenomas (RR, 1.89; 95% CI, 1.17-3.06). Stronger associations were observed among participants with advanced adenomas at baseline. Circulating 27-OHC was not associated with risk of hyperplastic polyps (RR, 0.90; 95% CI, 0.66-1.22) or sessile serrated adenomas/polyps (RR, 1.02; 95% CI, 0.50-2.07). Circulating 27-OHC may be a risk factor for colorectal adenomas but not serrated polyps. PREVENTION RELEVANCE: This study found that plasma concentration of 27-hydroxycholesterol, a metabolite of cholesterol that regulates lipid metabolism and acts as a selective estrogen receptor modulator, is associated with the risk of developing precursor lesions for colorectal cancer.",2021,"Circulating 27-OHC was not associated with risk of hyperplastic polyps (RR, 0.90; 95% CI, 0.66-1.22) or sessile serrated adenomas/polyps (RR, 1.02; 95% CI, 0.50-2.07).","['participants with advanced adenomas at baseline', 'Participants were between 45 and 75 years old, recently diagnosed with ≥1 colorectal adenoma, and followed for new colorectal polyps during colonoscopic surveillance', '1,246 participants']",['oxysterol 27-hydroxycholesterol (27-OHC'],"['Circulating 27-OHC', 'risk of hyperplastic polyps', 'Adjusted risk ratios (RR', 'risk of advanced adenomas']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1302401', 'cui_str': 'Adenoma of large intestine'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0949059', 'cui_str': 'Polyp of large intestine'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}]","[{'cui': 'C4277571', 'cui_str': 'Oxysterol'}, {'cui': 'C0172934', 'cui_str': '27-hydroxycholesterol'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0333983', 'cui_str': 'Hyperplastic polyp'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}]",1246.0,0.208792,"Circulating 27-OHC was not associated with risk of hyperplastic polyps (RR, 0.90; 95% CI, 0.66-1.22) or sessile serrated adenomas/polyps (RR, 1.02; 95% CI, 0.50-2.07).","[{'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Passarelli', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire. michael.n.passarelli@dartmouth.edu.'}, {'ForeName': 'Bonne M', 'Initials': 'BM', 'LastName': 'Thompson', 'Affiliation': 'Department of Molecular Genetics, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Jeffrey G', 'Initials': 'JG', 'LastName': 'McDonald', 'Affiliation': 'Department of Molecular Genetics, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Dale C', 'Initials': 'DC', 'LastName': 'Snover', 'Affiliation': 'Department of Pathology, Fairview Southdale Hospital, Edina, Minnesota.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Palys', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.'}, {'ForeName': 'Judy R', 'Initials': 'JR', 'LastName': 'Rees', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Barry', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Baron', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-20-0414'] 1813,33412120,Efficacy and safety of nintedanib in patients with systemic sclerosis-associated interstitial lung disease treated with mycophenolate: a subgroup analysis of the SENSCIS trial.,"BACKGROUND In the Safety and Efficacy of Nintedanib in Systemic Sclerosis (SENSCIS) trial, nintedanib reduced the rate of decline in forced vital capacity (FVC) in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Patients on stable treatment with mycophenolate for at least 6 months before randomisation could participate. The aim of this subgroup analysis was to examine the efficacy and safety of nintedanib by mycophenolate use at baseline. METHODS The SENSCIS trial was a randomised, double-blind, placebo-controlled trial, in which patients with SSc-ILD were randomly assigned (1:1) to receive 150 mg of oral nintedanib twice daily or placebo for at least 52 weeks. In a prespecified subgroup analysis, we analysed the primary endpoint of rate of decline in FVC over 52 weeks by mycophenolate use at baseline. In a post-hoc analysis, we analysed the proportion of patients with an absolute decrease in FVC of at least 3·3% predicted at week 52 (proposed minimal clinically important difference estimate for worsening of FVC in patients with SSc-ILD) in subgroups by mycophenolate use at baseline. Adverse events were reported in subgroups by mycophenolate use at baseline. Analyses were done in all participants who received at least one dose of study drug. We analysed the annual rate of decline in FVC using a random coefficient regression model (with random slopes and intercepts) including anti-topoisomerase I antibody status, age, height, sex, and baseline FVC as covariates and terms for baseline-by-time, treatment-by-subgroup, and treatment-by-subgroup-by-time interactions. SENSCIS is registered with ClinicalTrials.gov, NCT02597933, and is now complete. FINDINGS Between Nov 30, 2015, and Oct 31, 2017, 819 participants were screened and 576 were enrolled, randomly assigned to, and treated with nintedanib (n=288) or placebo (n=288). 139 (48%) of 288 in the nintedanib group and 140 (49%) of 288 in the placebo group were taking mycophenolate at baseline. In patients taking mycophenolate at baseline, the adjusted mean annual rate of decline in FVC was -40·2 mL per year (SE 19·8) with nintedanib and -66·5 mL per year (19·3) with placebo (difference: 26·3 mL per year [95% CI -27·9 to 80·6]). In patients not taking mycophenolate at baseline, the adjusted mean annual rate of decline in FVC was -63·9 mL per year (SE 19·3) with nintedanib and -119·3 mL per year (19·0) with placebo (difference: 55·4 mL per year [95% CI 2·3 to 108·5]). We found no heterogeneity in the effect of nintedanib versus placebo on the annual rate of decline in FVC between the subgroups by mycophenolate use (p value for interaction=0·45). In a post-hoc analysis, the proportion of patients with an absolute decrease in FVC of at least 3·3% predicted was lower with nintedanib than with placebo in both patients taking mycophenolate (40 [29%] of 138 vs 56 [40%] of 140; odds ratio 0·61 [0·37 to 1·01]) and those not taking mycophenolate (59 [40%] of 149 vs 70 [47%] of 148; 0·73 [0·46 to 1·16]) at baseline. The adverse event profile of nintedanib was similar between the subgroups. Diarrhoea, the most common adverse event, was reported in 106 (76%) of 139 patients in the nintedanib group and 48 (34%) of 140 in the placebo group among those taking mycophenolate at baseline, and in 112 (75%) of 149 in the nintedanib group and 43 (29%) of 148 in the placebo group among those not taking mycophenolate at baseline. Over the entire trial period, 19 patients died (ten in the nintedanib group and nine in the placebo group). One death in the nintedanib group was considered to be related to study drug. INTERPRETATION Nintedanib reduced the progression of interstitial lung disease both in patients with SSc-ILD who were and were not using mycophenolate at baseline, with no heterogeneity in its treatment effect detected between the subgroups. The adverse event profile of nintedanib was similar in the subgroups by mycophenolate use. Our findings suggest that the combination of mycophenolate and nintedanib offers a safe treatment option for patients with SSc-ILD. More data are needed on the benefits of initial combination therapy versus a sequential approach to treatment of SSc-ILD. FUNDING Boehringer Ingelheim.",2021,We found no heterogeneity in the effect of nintedanib versus placebo on the annual rate of decline in FVC between the subgroups by mycophenolate use (p value for interaction=0·45).,"['Between Nov 30, 2015, and Oct 31, 2017, 819 participants were screened and 576 were enrolled', 'patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD', 'patients with SSc-ILD', 'patients with systemic sclerosis-associated interstitial lung disease treated with']","['nintedanib', 'mycophenolate', 'oral nintedanib twice daily or placebo', 'placebo', 'mycophenolate and nintedanib', 'Nintedanib']","['rate of decline in FVC', 'adverse event profile of nintedanib', 'Efficacy and safety', 'Adverse events', 'efficacy and safety', 'Diarrhoea', 'FVC']","[{'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0036429', 'cui_str': 'Sclerosis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C2930789', 'cui_str': 'nintedanib'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2930789', 'cui_str': 'nintedanib'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",819.0,0.597292,We found no heterogeneity in the effect of nintedanib versus placebo on the annual rate of decline in FVC between the subgroups by mycophenolate use (p value for interaction=0·45).,"[{'ForeName': 'Kristin B', 'Initials': 'KB', 'LastName': 'Highland', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Distler', 'Affiliation': 'Department of Rheumatology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Kuwana', 'Affiliation': 'Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Allanore', 'Affiliation': 'Department of Rheumatology A, Descartes University, APHP, Cochin Hospital, Paris, France.'}, {'ForeName': 'Shervin', 'Initials': 'S', 'LastName': 'Assassi', 'Affiliation': 'Division of Rheumatology and Clinical Immunogenetics, University of Texas McGovern Medical School, Houston, TX, USA.'}, {'ForeName': 'Arata', 'Initials': 'A', 'LastName': 'Azuma', 'Affiliation': 'Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Bourdin', 'Affiliation': 'PhyMedExp, University of Montpellier, INSERM U1046, CNRS UMR 9214, Montpellier, France; Department of Respiratory Diseases, University of Montpellier, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Denton', 'Affiliation': 'University College London Division of Medicine, Centre for Rheumatology and Connective Tissue Diseases, London, UK.'}, {'ForeName': 'Jörg H W', 'Initials': 'JHW', 'LastName': 'Distler', 'Affiliation': 'Department of Internal Medicine 3 - Rheumatology and Immunology, Friedrich-Alexander-University Erlangen-Nürnberg (FAU) and University Hospital Erlangen, Erlangen, Germany.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Hoffmann-Vold', 'Affiliation': 'Department of Rheumatology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Khanna', 'Affiliation': 'Department of Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Maureen D', 'Initials': 'MD', 'LastName': 'Mayes', 'Affiliation': 'Division of Rheumatology and Clinical Immunogenetics, University of Texas McGovern Medical School, Houston, TX, USA.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Raghu', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Madelon C', 'Initials': 'MC', 'LastName': 'Vonk', 'Affiliation': 'Department of Rheumatology, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Gahlemann', 'Affiliation': 'Boehringer Ingelheim (Schweiz), Basel, Switzerland.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Clerisme-Beaty', 'Affiliation': 'Boehringer Ingelheim International, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Mannaig', 'Initials': 'M', 'LastName': 'Girard', 'Affiliation': 'Boehringer Ingelheim Pharma, Biberach, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Stowasser', 'Affiliation': 'Boehringer Ingelheim International, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Zoz', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USA.'}, {'ForeName': 'Toby M', 'Initials': 'TM', 'LastName': 'Maher', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK; National Institute for Health Research Clinical Research Facility, Royal Brompton Hospital, London, UK; Keck School of Medicine, University of Southern California, Los Angeles, CA, USA. Electronic address: toby.maher@med.usc.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30330-1'] 1814,33411952,The effect of the ischaemic compression technique on pain and functionality in temporomandibular disorders: A randomised clinical trial.,"BACKGROUND Interventions addressing pain and impaired functionality in individuals with temporomandibular disorders (TMDs) are needed. OBJECTIVE To compare the effects of 4 weeks of exercise combined with ischaemic compression and exercise alone in patients with TMDs. METHODS Fifty patients who were diagnosed with TMDs were randomised into Group 1 (exercise combined with ischaemic compression technique) (n = 25) or Group 2 (exercise alone) (n = 25). Both groups performed 4 weeks of Rocabado's exercise and 3 weeks of postural exercise, while Group 1 received ischaemic compression to the masseter muscle for a total of 3 sessions in addition to exercise. A ruler was used to assess range of motion (ROM) (painless mouth opening (PMO), maximum mouth opening, maximum assisted mouth opening (MAMO), left lateral movement and right lateral movement), the visual analogue scale and graded chronic pain scale were used to assess pain, an algometer was used to determine the pain pressure threshold (PPT), and the 8-item jaw functional limitation scale was used to assess, functionality. The assessments were performed at baseline, at week 1 and at week 4. RESULTS The participants in Group 1 exhibited larger PMO (F = 5.26, P = .02) and MAMO values (F = 6.71, P = .01) than did the patients in Group 2 at week 1. The effect size was small for MAMO (ES = 0.27) and moderate for PMO (ES = 0.51). However, there were no significant differences in any other outcomes between groups at week 1 or 4. CONCLUSION In summary, this randomised controlled trial indicates that exercise combined with ICT and exercise alone have similar effects on ROM, pain, the PPT and functionality in patients with TMDs.",2021,"The participants in Group 1 exhibited larger PMO (F=5.26, P=0.02) and MAMO values (F=6.71, P=0.01) than did the patients in Group 2 at week 1.","['individuals with temporomandibular disorders (TMDs', 'Temporomandibular Disorders', 'patients with TMDs', 'Fifty patients who were diagnosed with TMDs']","['Ischaemic Compression Technique', ""Rocabado's exercise and three weeks of postural exercise, while Group 1 received ischaemic compression to the masseter muscle for a total of three sessions in addition to exercise"", 'exercise combined with ischaemic compression and exercise alone', 'ICT and exercise alone', 'Group 1 (exercise combined with ischaemic compression technique) (n=25) or Group 2 (exercise alone) ']","['Pain and Functionality', 'pain pressure threshold (PPT), and the 8-item jaw functional limitation scale', 'larger PMO', 'range of motion (ROM) (painless mouth opening (PMO), maximum mouth opening, maximum assisted mouth opening (MAMO), left lateral movement and right lateral movement), the visual analogue scale and graded chronic pain scale', 'ROM, pain, the PPT and functionality', 'MAMO values']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4082109', 'cui_str': 'Three weeks'}, {'cui': 'C0150716', 'cui_str': 'Postural exercises'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0024876', 'cui_str': 'Masseter muscle structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0234226', 'cui_str': 'Painless'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0450414', 'cui_str': 'Lateral to the left'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0450415', 'cui_str': 'Lateral to the right'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",50.0,0.180082,"The participants in Group 1 exhibited larger PMO (F=5.26, P=0.02) and MAMO values (F=6.71, P=0.01) than did the patients in Group 2 at week 1.","[{'ForeName': 'Duygu', 'Initials': 'D', 'LastName': 'Şahin', 'Affiliation': 'Division of Physiotheraphy and Rehabilitation, Faculty of Health Sciences, Istanbul Aydin University, İstanbul, Turkey.'}, {'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Kaya Mutlu', 'Affiliation': 'Division of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Istanbul University-Cerrahpasa, Istanbul, Turkey.'}, {'ForeName': 'Olcay', 'Initials': 'O', 'LastName': 'Şakar', 'Affiliation': 'Department of Prosthodontics, Faculty of Dentistry, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Gökçen', 'Initials': 'G', 'LastName': 'Ateş', 'Affiliation': 'Department of Prosthodontics, Faculty of Dentistry, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Şebnem', 'Initials': 'Ş', 'LastName': 'İnan', 'Affiliation': 'Department of Prosthodontics, Faculty of Dentistry, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Hanifegül', 'Initials': 'H', 'LastName': 'Taşkıran', 'Affiliation': 'Division of Physiotheraphy and Rehabilitation, Faculty of Health Sciences, Istanbul Aydin University, İstanbul, Turkey.'}]",Journal of oral rehabilitation,['10.1111/joor.13145'] 1815,33377998,A randomized controlled trial comparing community lifestyle interventions to improve adherence to diet and physical activity recommendations: the VitalUM study.,"Worldwide, adherence to national guidelines for physical activity (PA), and fruit and vegetable consumption is recommended to promote health and reduce the risk for (chronic) disease. This study reports on the effectiveness of various social-cognitive interventions to improve adherence to guidelines and the revealed adherence predictors. Participants (n = 1,629), aged 45-70 years, randomly selected and recruited in 2005-2006 from 23 Dutch general practices, were randomized (centralized stratified allocation) to four groups to receive a 12-month lifestyle intervention targeting guideline adherence for PA and fruit and vegetable consumption. Study groups received either four computer-tailored print communication (TPC) letters (n = 405), four telephone motivational interviewing (TMI) sessions (n = 407), a combined intervention (two TPC letters and two TMI sessions, n = 408), or no intervention (control group, n = 409). After the baseline assessment, all parties were aware of the treatment groups. Outcomes were measured with self-report postal questionnaires at baseline, 25, 47 and 73 weeks. For PA, all three interventions were associated with better guideline adherence than no intervention. Odds ratios for TPC, TMI and the combined intervention were 1.82 (95% CI 1.31; 2.54), 1.57 (95% CI 1.13; 2.18), and 2.08 (95% CI 1.50; 2.88), respectively. No pedometer effects were found. For fruit and vegetable consumption, TPC seemed superior to those in the other groups. Odd ratio for fruit and vegetable consumption were 1.78 (95% CI 1.32; 2.41) and 1.73 (95% CI 1.28; 2.33), respectively. For each behaviour, adherence was predicted by self-efficacy expectations, habit strength and stages of change, whereas sex, awareness and the number of action plans predicted guideline adherence for fruit and vegetable intake. The season predicted the guideline adherence for PA and fruit consumption. The odds ratios revealed were equivalent to modest effects sizes, although they were larger than those reported in systematic reviews. This study indicated that less resource intensive interventions might have the potential for a large public health impact when widely implemented. The strengths of this study were the participation of lower educated adults and evaluation of maintenance effects. (Trial NL1035, 2007-09-06).",2021,"Odds ratios for TPC, TMI and the combined intervention were 1.82 (95% CI 1.31; 2.54), 1.57 (95% CI 1.13; 2.18), and 2.08 (95% CI 1.50; 2.88), respectively.","['Participants (n\u2009=\u20091,629), aged 45-70\xa0years, randomly selected and recruited in 2005-2006 from 23 Dutch general practices']","['lifestyle intervention targeting guideline adherence for PA and fruit and vegetable consumption', 'four computer-tailored print communication (TPC) letters (n\u2009=\u2009405), four telephone motivational interviewing (TMI) sessions (n\u2009=\u2009407), a combined intervention (two TPC letters and two TMI sessions, n\u2009=\u2009408), or no intervention (control group, n\u2009=\u2009409', 'community lifestyle interventions', 'various social-cognitive interventions']","['Odds ratios for TPC, TMI and the combined intervention', 'Odd ratio for fruit and vegetable consumption', 'guideline adherence', 'self-report postal questionnaires']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0525059', 'cui_str': 'Guideline Adherence'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C4517768', 'cui_str': '405'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4517769', 'cui_str': '408'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0525059', 'cui_str': 'Guideline Adherence'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0358642,"Odds ratios for TPC, TMI and the combined intervention were 1.82 (95% CI 1.31; 2.54), 1.57 (95% CI 1.13; 2.18), and 2.08 (95% CI 1.50; 2.88), respectively.","[{'ForeName': 'Hilde Marijke', 'Initials': 'HM', 'LastName': 'van Keulen', 'Affiliation': 'Department of Health Promotion, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'van Breukelen', 'Affiliation': 'Department of Methodology and Statistics, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'de Vries', 'Affiliation': 'Department of Health Promotion, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Brug', 'Affiliation': 'Department of Epidemiology and Biostatistics, National Institute for Public Health and the Environment (RIVM), Utrecht RIVM and VU Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Mesters', 'Affiliation': 'Department of Epidemiology, Maastricht University, Maastricht, The Netherlands. ilse.mesters@maastrichtuniversity.nl.'}]",European journal of epidemiology,['10.1007/s10654-020-00708-2'] 1816,33377987,Recombinant FVIIIFc Versus BAY 94-9027 for Treatment of Patients with Haemophilia A: Comparative Efficacy Using a Matching Adjusted Indirect Comparison.,"INTRODUCTION Prophylaxis with recombinant factor VIII (rFVIII) is the current standard of care for haemophilia A. Several approaches have been used to extend the half-life of rFVIII to improve prophylaxis outcomes. An indirect comparison of pivotal clinical trial data was performed to evaluate the relative efficacy of two extended half-life therapies approved for the prophylactic treatment of haemophilia A: recombinant FVIII-IgG 1 Fc domain fusion protein (rFVIIIFc) and pegylated rFVIII (BAY 94-9027). METHODS Matching-adjusted indirect comparison (MAIC) was conducted to compare the rFVIIIFc individualised prophylaxis arm of the A-LONG phase III clinical trial (n = 117) and the BAY 94-9027 approved dosing regimens of the PROTECT VIII phase II/III study (n = 110). Following matching for baseline characteristics, mean annualised bleeding rate (ABR) and the proportion of patients with zero bleeds were compared for rFVIIIFc and BAY 94-9027. Additional supportive analyses comparing rFVIIIFc individualised prophylaxis and the individual prophylaxis regimens included in the PROTECT VIII group (twice weekly, and every 5 and 7 days [Q5D and Q7D]) were conducted. RESULTS Mean ABR was lower in the rFVIIIFc individualised prophylaxis group versus the BAY 94-9027 pooled prophylaxis population (3.0 versus 4.9), providing a clinically relevant and statistically significant difference (mean difference [MD] - 1.9; 95% confidence interval [CI] - 3.5 to - 0.4). A statistically significant difference in ABR was also observed for rFVIIIFc compared with BAY 94-9027 Q7D (3.2 versus 6.4; MD - 3.3; 95% CI - 6.4 to - 0.2). The difference in the proportion of patients with zero bleeds between rFVIIIFc (46.5%) and BAY 94-9027 pooled prophylaxis population (38.2%) was not statistically significant (odds ratio 1.4; 95% CI 0.8 to 2.5). CONCLUSIONS This indirect treatment comparison indicates a statistically significant and clinically relevant difference in ABR favouring individualised prophylaxis with rFVIIIFc versus BAY 94-9027 prophylaxis. The proportion of patients with zero bleeds was numerically greater with rFVIIIFc treatment but did not achieve statistical significance.",2021,"Mean ABR was lower in the rFVIIIFc individualised prophylaxis group versus the BAY 94-9027 pooled prophylaxis population (3.0 versus 4.9), providing a clinically relevant and statistically significant difference (mean difference [MD] - 1.9; 95% confidence interval [CI] - 3.5 to - 0.4).","['Patients with Haemophilia', 'haemophilia']","['recombinant FVIII-IgG 1', 'Fc domain fusion protein (rFVIIIFc) and pegylated rFVIII', 'recombinant factor VIII (rFVIII', 'Recombinant FVIIIFc']","['Mean ABR', 'ABR', 'proportion of patients with zero bleeds', 'bleeding rate (ABR) and the proportion of patients with zero bleeds']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}]","[{'cui': 'C2732002', 'cui_str': 'Antihemophilic Factor, Human Recombinant'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0162768', 'cui_str': 'Fusion protein'}, {'cui': 'C0795577', 'cui_str': 'recombinant antihemophilic factor VIII'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0919414', 'cui_str': '0'}]",,0.0677316,"Mean ABR was lower in the rFVIIIFc individualised prophylaxis group versus the BAY 94-9027 pooled prophylaxis population (3.0 versus 4.9), providing a clinically relevant and statistically significant difference (mean difference [MD] - 1.9; 95% confidence interval [CI] - 3.5 to - 0.4).","[{'ForeName': 'Zalmai', 'Initials': 'Z', 'LastName': 'Hakimi', 'Affiliation': 'Sobi, Stockholm, Sweden. Zalmai.Hakimi@sobi.com.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Santagostino', 'Affiliation': 'Sobi, Basel, Switzerland.'}, {'ForeName': 'Maarten J', 'Initials': 'MJ', 'LastName': 'Postma', 'Affiliation': 'University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Jameel', 'Initials': 'J', 'LastName': 'Nazir', 'Affiliation': 'Sobi, Stockholm, Sweden.'}]",Advances in therapy,['10.1007/s12325-020-01599-1'] 1817,33350732,The effectiveness of a WeChat-based multimodal nursing program for women with breast cancer: A randomized controlled trial protocol.,,2020,,['women with breast cancer'],['WeChat-based multimodal nursing program'],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.109057,,"[{'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhao', 'Affiliation': 'Department of Operating Room, The Second Affiliated Hospital of Hainan Medical University, Hainan, 570311, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Yin', 'Affiliation': ''}, {'ForeName': 'Xiaofang', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Yuxia', 'Initials': 'Y', 'LastName': 'Zhong', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000023526'] 1818,33378614,Detrusor Overactivity May Be a Prognostic Factor for Better Response to Combination Therapy Over Monotherapy in Male Patients With Benign Prostatic Enlargement and Storage Lower Urinary Tract Symptoms.,"PURPOSE Several trials have shown that in men with overactive bladder (OAB) and benign prostate enlargement (BPE), the combination of an α-blocker with an anticholinergic is superior to α-blocker monotherapy. The purpose of this study is to explore whether urodynamic detrusor overactivity (DO) affects clinical outcomes in men with BPE and OAB. METHODS This is a post hoc analysis of a prospective, randomized trial, designed to evaluate the changes of morphometric parameters of the prostate following monotherapy or combination therapy in men with BPE-OAB. The initial study recruited men aged ≥50 years, with BPE and predominantly storage lower urinary tract symptoms (LUTS). Patients were randomized to receive tamsulosin monotherapy or a combination of tamsulosin and solifenacin for 26 weeks. All participants completed a 3-day bladder diary and the International Prostate Symptom Score (IPSS), and then underwent pressure-flow and ultrasonographic studies. Data were stratified and analysed based on the urodynamic observation of DO at baseline (DO vs. non-DO). The primary endpoint was the mean change in urgency episodes from baseline. Secondary outcomes were the changes in nocturia, total IPSS, and urodynamic parameters. RESULTS Sixty-nine men were initially randomized, but only 60 men were included in this analysis. Urgency episodes significantly improved in men with DO who received combination therapy compared to the DO monotherapy subgroup (P=0.04) or to the non-DO combination treatment subgroup (P=0.038). Nocturia also improved in the DO combination treatment subgroup as compared to the non-DO combination subgroup (P=0.037). The 24-hour frequency and total IPSS significantly improved from baseline without significant differences among the subgroups. CONCLUSION The present study suggests that baseline DO could be a prognostic factor for a better response to combination therapy over monotherapy in men with BPE and storage LUTS.",2021,Urgency episodes significantly improved in men with DO who received combination therapy compared to the DO monotherapy subgroup (P=0.04) or to the non-DO combination treatment subgroup (P=0.038).,"['men with overactive bladder (OAB) and benign prostate enlargement (BPE', 'men with BPE-OAB', 'men with BPE and OAB', 'men with BPE and storage LUTS', 'Male Patients With Benign Prostatic Enlargement and Storage Lower Urinary Tract Symptoms', 'men aged ≥50 years, with BPE and predominantly storage lower urinary tract symptoms (LUTS', 'Results\n\n\nSixty-nine men were initially randomized, but only 60 men']","['Combination Therapy', 'monotherapy or combination therapy', 'tamsulosin monotherapy or a combination of tamsulosin and solifenacin']","['3-day bladder diary and the International Prostate Symptom Score (IPSS', 'Urgency episodes', 'Nocturia', 'changes in nocturia, total IPSS, and urodynamic parameters', '24-hour frequency and total IPSS', 'mean change in urgency episodes']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0426732', 'cui_str': 'Large prostate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]","[{'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C3652708', 'cui_str': 'tamsulosin and solifenacin'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0028734', 'cui_str': 'Nocturia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1997470', 'cui_str': 'Total international prostate symptom score'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",69.0,0.168319,Urgency episodes significantly improved in men with DO who received combination therapy compared to the DO monotherapy subgroup (P=0.04) or to the non-DO combination treatment subgroup (P=0.038).,"[{'ForeName': 'Vasileios', 'Initials': 'V', 'LastName': 'Sakalis', 'Affiliation': 'Department of Urology, Agios Pavlos General Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Vasileios', 'Initials': 'V', 'LastName': 'Sfiggas', 'Affiliation': 'Department of Urology, Hippokration General Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Vouros', 'Affiliation': 'Department of Urology, Hippokration General Hospital, Thessaloniki, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Salpiggidis', 'Affiliation': 'Department of Urology, Hippokration General Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Papathanasiou', 'Affiliation': 'Department of Urology, Hippokration General Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Apostolos', 'Initials': 'A', 'LastName': 'Apostolidis', 'Affiliation': 'The 2nd Department of Urology, Papageorgiou General Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}]",International neurourology journal,['10.5213/inj.2040188.094'] 1819,33378609,Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine.,"BACKGROUND Vaccines are needed to prevent coronavirus disease 2019 (Covid-19) and to protect persons who are at high risk for complications. The mRNA-1273 vaccine is a lipid nanoparticle-encapsulated mRNA-based vaccine that encodes the prefusion stabilized full-length spike protein of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes Covid-19. METHODS This phase 3 randomized, observer-blinded, placebo-controlled trial was conducted at 99 centers across the United States. Persons at high risk for SARS-CoV-2 infection or its complications were randomly assigned in a 1:1 ratio to receive two intramuscular injections of mRNA-1273 (100 μg) or placebo 28 days apart. The primary end point was prevention of Covid-19 illness with onset at least 14 days after the second injection in participants who had not previously been infected with SARS-CoV-2. RESULTS The trial enrolled 30,420 volunteers who were randomly assigned in a 1:1 ratio to receive either vaccine or placebo (15,210 participants in each group). More than 96% of participants received both injections, and 2.2% had evidence (serologic, virologic, or both) of SARS-CoV-2 infection at baseline. Symptomatic Covid-19 illness was confirmed in 185 participants in the placebo group (56.5 per 1000 person-years; 95% confidence interval [CI], 48.7 to 65.3) and in 11 participants in the mRNA-1273 group (3.3 per 1000 person-years; 95% CI, 1.7 to 6.0); vaccine efficacy was 94.1% (95% CI, 89.3 to 96.8%; P<0.001). Efficacy was similar across key secondary analyses, including assessment 14 days after the first dose, analyses that included participants who had evidence of SARS-CoV-2 infection at baseline, and analyses in participants 65 years of age or older. Severe Covid-19 occurred in 30 participants, with one fatality; all 30 were in the placebo group. Moderate, transient reactogenicity after vaccination occurred more frequently in the mRNA-1273 group. Serious adverse events were rare, and the incidence was similar in the two groups. CONCLUSIONS The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease. Aside from transient local and systemic reactions, no safety concerns were identified. (Funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases; COVE ClinicalTrials.gov number, NCT04470427.).",2021,"The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease.","['participants 65 years of age or older', '15,210 participants in each group', '30,420 volunteers', '99 centers across the United States', 'Persons at high risk for SARS-CoV-2 infection or its complications']","['mRNA-1273', 'vaccine or placebo', 'placebo', 'mRNA-1273 SARS-CoV-2 Vaccine']","['Efficacy', 'vaccine efficacy', 'Moderate, transient reactogenicity', 'Symptomatic Covid-19 illness', 'Severe Covid-19', 'Covid-19 illness', 'Efficacy and Safety']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]","[{'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",30420.0,0.729429,"The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease.","[{'ForeName': 'Lindsey R', 'Initials': 'LR', 'LastName': 'Baden', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': 'Hana M', 'Initials': 'HM', 'LastName': 'El Sahly', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Essink', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Kotloff', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Frey', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'Novak', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Diemert', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Spector', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Rouphael', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': 'C Buddy', 'Initials': 'CB', 'LastName': 'Creech', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McGettigan', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': 'Shishir', 'Initials': 'S', 'LastName': 'Khetan', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Segall', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Solis', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Brosz', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Fierro', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Schwartz', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Neuzil', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Corey', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gilbert', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Janes', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Follmann', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Marovich', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mascola', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Polakowski', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Ledgerwood', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': 'Barney S', 'Initials': 'BS', 'LastName': 'Graham', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': 'Hamilton', 'Initials': 'H', 'LastName': 'Bennett', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': 'Rolando', 'Initials': 'R', 'LastName': 'Pajon', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': 'Conor', 'Initials': 'C', 'LastName': 'Knightly', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Leav', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Deng', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': 'Honghong', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Ivarsson', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': 'Tal', 'Initials': 'T', 'LastName': 'Zaks', 'Affiliation': ""From Brigham and Women's Hospital (L.R.B.), Boston, and Moderna, Cambridge (H.B., R.P., C.K., B.L., W.D., H.Z., S.H., M.I., J. Miller, T.Z.) - both in Massachusetts; Baylor College of Medicine (H.M.E.S.) and Centex Studies (J.S.) - both in Houston; Meridian Clinical Research, Savannah (B.E., S.K., A.B.), and Emory University (N.R.) and Atlanta Clinical Research Center (N.S.), Atlanta - all in Georgia; University of Maryland School of Medicine, Baltimore (K.K., K.N.), and National Institute of Allergy and Infectious Diseases, Bethesda (D.F., M.M., J. Mascola, L.P., J.L., B.S.G.) - both in Maryland; Saint Louis University School of Medicine, St. Louis (S.F.); University of Illinois, Chicago, Chicago (R.N.); George Washington University School of Medicine and Health Sciences, Washington, DC (D.D.); University of California, San Diego, San Diego (S.A.S.); Vanderbilt University School of Medicine, Nashville (C.B.C.); Quality of Life Medical and Research Center, Tucson, AZ (J. McGettigan); Johnson County Clin-Trials, Lenexa, KS (C.F.); Research Centers of America, Hollywood, FL (H.S.); and Fred Hutchinson Cancer Research Center, Seattle (L.C., P.G., H.J.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2035389'] 1820,33385318,"Bioequivalence Analysis of 2 Dapoxetine Hydrochloride Formulations in Healthy Chinese Male Volunteers Under Fed and Fasting Conditions: A Randomized, Open-Label, 2-Sequence, 2-Period, 2-Way Crossover Study.","This study assessed whether the reference and test formulations of dapoxetine hydrochloride were bioequivalent under fed and fasting conditions postadministration of a single dose as well as evaluated the safety profile of these 2 formulations. This study was a randomized, single-center, 2-period, open-label, 2-way crossover design study with a washout period of 7 days between each period. The study included 80 subjects, 40 under fed and 40 under fasting conditions. During each study period, the subjects were administered a single oral dose of either the reference or the test formulation, followed by collection of plasma samples 70 hours postdose. High-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) was performed to determine the concentrations of dapoxetine in plasma samples along with the calculation of C max , AUC 0-t, and AUC 0-inf . In addition, adverse events were monitored to determine the safety of these formulations. The geometric mean ratio (90%CI) for the reference and test formulations was 86% to 100%, 89% to 103%, and 89% to 103% under fasting conditions and 92% to 107%, 91% to 100%, and 92% to 101% under fed conditions for C max , AUC 0-t , and AUC 0-inf , respectively. The 90%CIs for the test/reference ratio for AUC and C max were within the acceptable limits of bioequivalence, thus demonstrating bioequivalence for these 2 dapoxetine hydrochloride formulations.",2021,"The 90%CIs for the test/reference ratio for AUC and C max were within the acceptable limits of bioequivalence, thus demonstrating bioequivalence for these 2 dapoxetine hydrochloride formulations.","['Healthy Chinese Male Volunteers', '80 subjects, 40 under fed and 40 under fasting conditions']","['Dapoxetine Hydrochloride Formulations', 'dapoxetine hydrochloride', 'Under Fed and Fasting Conditions']","['geometric mean ratio (90%CI', 'adverse events']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0342895', 'cui_str': 'Fish-eye disease'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0970823', 'cui_str': 'Dapoxetine hydrochloride'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0342895', 'cui_str': 'Fish-eye disease'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",80.0,0.042877,"The 90%CIs for the test/reference ratio for AUC and C max were within the acceptable limits of bioequivalence, thus demonstrating bioequivalence for these 2 dapoxetine hydrochloride formulations.","[{'ForeName': 'Keyu', 'Initials': 'K', 'LastName': 'Yan', 'Affiliation': 'School of Pharmacy Lanzhou University, Lanzhou University, Lanzhou, PR China.'}, {'ForeName': 'Gehang', 'Initials': 'G', 'LastName': 'Ju', 'Affiliation': 'School of Pharmacy Lanzhou University, Lanzhou University, Lanzhou, PR China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Tan', 'Affiliation': 'Jiangsu Lianhuan Pharmaceutical Co., Ltd., Jiangsu, PR China.'}, {'ForeName': 'Lijiao', 'Initials': 'L', 'LastName': 'Zeng', 'Affiliation': 'Wuhan Hongren Biopharmaceutical Inc., Hubei, PR China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Qiu', 'Affiliation': 'Phase I Clinical Unit, Lanzhou University Second Hospital, Lanzhou, Gansu, PR China.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.866'] 1821,33386829,"Z-score neurofeedback, heart rate variability biofeedback, and brain coaching for older adults with memory concerns.","BACKGROUND The three-month, multi-domain Memory Boot Camp program incorporates z-score neurofeedback (NFB), heart rate variability (HRV) biofeedback, and one-on-one coaching to teach memory skills and encourage behavior change in diet, sleep, physical fitness, and stress reduction. OBJECTIVE This prospective trial evaluates the Memory Boot Camp program for adults ages 55 to 85 with symptoms of Mild Cognitive Impairment (MCI) and subjective memory complaints. METHODS Participants were evaluated via the Montreal Cognitive Assessment (MoCA), NeuroTrax Global Cognitive Score, measures of anxiety, depression, sleep, quality of life, quantitative electroencephalography (QEEG), and HRV parameters at four timepoints: baseline, pre-program, post-program, and follow-up. The trial included a three-month waiting period between baseline and pre-program, such that each participant acted as their own control, and follow-up took place six months after completion of the program. RESULTS Participants' MoCA scores and self-reported measures of anxiety, depression, sleep quality, and quality of life improved after treatment, and these changes were maintained at follow-up. Physiological changes in HRV parameters after treatment were not significant, however, breathing rate and QEEG parameters were improved at post-program and maintained at follow-up. Finally, participants' improvement in MoCA score over the treatment period was correlated with their improvement in two brain oscillation parameters targeted by the z-score NFB protocol: relative power of delta and relative power of theta. CONCLUSIONS Trial results suggest that the Memory Boot Camp program is a promising treatment strategy for older adults with symptoms of MCI and subjective memory complaints.",2021,"Physiological changes in HRV parameters after treatment were not significant, however, breathing rate and QEEG parameters were improved at post-program and maintained at follow-up.","['older adults with memory concerns', 'older adults with symptoms of MCI and subjective memory complaints', 'adults ages 55 to 85 with symptoms of Mild Cognitive Impairment (MCI) and subjective memory complaints', 'Participants were evaluated via the']",['Memory Boot Camp program'],"['Z-score neurofeedback, heart rate variability biofeedback, and brain coaching', 'Montreal Cognitive Assessment (MoCA), NeuroTrax Global Cognitive Index, measures of anxiety, depression, sleep, quality of life, quantitative electroencephalography (QEEG), and HRV parameters', 'MoCA scores and self-reported measures of anxiety, depression, sleep quality, and quality of life', 'MoCA score', 'z-score neurofeedback (NFB), heart rate variability (HRV) biofeedback', 'breathing rate and QEEG parameters', 'behavior change in diet, sleep, physical fitness, and stress reduction', 'Physiological changes in HRV parameters']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0331794', 'cui_str': 'Boots'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.0161015,"Physiological changes in HRV parameters after treatment were not significant, however, breathing rate and QEEG parameters were improved at post-program and maintained at follow-up.","[{'ForeName': 'Kyle D', 'Initials': 'KD', 'LastName': 'Meeuwsen', 'Affiliation': 'Neurocore, Grand Rapids, MI, USA.'}, {'ForeName': 'Kayleah M', 'Initials': 'KM', 'LastName': 'Groeneveld', 'Affiliation': 'Neurocore, Grand Rapids, MI, USA.'}, {'ForeName': 'Linda A', 'Initials': 'LA', 'LastName': 'Walker', 'Affiliation': 'Neurocore, Grand Rapids, MI, USA.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Mennenga', 'Affiliation': 'Neurocore, Grand Rapids, MI, USA.'}, {'ForeName': 'Rachel K', 'Initials': 'RK', 'LastName': 'Tittle', 'Affiliation': 'Neurocore, Grand Rapids, MI, USA.'}, {'ForeName': 'Elyse K', 'Initials': 'EK', 'LastName': 'White', 'Affiliation': 'Neurocore, Grand Rapids, MI, USA.'}]",Restorative neurology and neuroscience,['10.3233/RNN-201053'] 1822,33386217,Decline in eGFR over time and incidence of cardiovascular events: Shinken database analysis.,"BACKGROUND It has been reported that a large decline in estimated glomerular filtration rate (eGFR) over time is associated with increased incidence of cardiovascular disease. We investigated whether this association differs according to the baseline eGFR. METHODS A total of 4666 patients (male 71%) with measurements of eGFR at both baseline and 1 year and that had no cardiovascular events at 1-year follow-up were retrieved from the Shinken Database between June 2004 and March 2015. The study population was divided into three groups by baseline eGFR (mL/min/1.73 m 2 ): high (≥60, n = 1650), intermediate (45-59, n = 1947), and low (<45, n = 1069) eGFR groups. Each eGFR group was further divided into two groups by eGFR slope (change at 1 year, <-10 and ≥-10 mL/min/1.73 m 2 ). The patient characteristics and the incidences of cardiovascular events within 3 years (after 1-year follow-up) were compared between the negatively large eGFR slope (<-10) and others (≥-10) in each eGFR group. RESULTS A total of 187 cardiovascular events occurred during the mean follow-up of 2.8 ± 0.6 years. The adjusted hazard ratios of eGFR slope (<-10 with reference to ≥-10) were 2.37 (95% CI, 1.28-4.40), 3.10 (95% CI, 1.78-5.40), and 2.66 (95% CI, 1.15-6.13) in the high, middle, and low eGFR groups, respectively. Similar results were found in patients with structural heart disease, but not in those without. CONCLUSIONS Decline in eGFR was associated with an increase in cardiovascular events, and this effect was consistent regardless of the baseline eGFR.",2021,"CONCLUSIONS Decline in eGFR was associated with an increase in cardiovascular events, and this effect was consistent regardless of the baseline eGFR.",['4666 patients (male 71%) with measurements of eGFR at both baseline and 1 year and that had no cardiovascular events at 1-year follow-up were retrieved from the Shinken Database between June 2004 and March 2015'],['baseline eGFR'],"['eGFR over time and incidence of cardiovascular events', 'cardiovascular events', 'adjusted hazard ratios of eGFR slope']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",4666.0,0.0827612,"CONCLUSIONS Decline in eGFR was associated with an increase in cardiovascular events, and this effect was consistent regardless of the baseline eGFR.","[{'ForeName': 'Tomoki', 'Initials': 'T', 'LastName': 'Fujisawa', 'Affiliation': 'Department of Cardiovascular Medicine, The Cardiovascular Institute, Tokyo, Japan. Electronic address: accordingtoplan6@gmail.com.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Suzuki', 'Affiliation': 'Department of Cardiovascular Medicine, The Cardiovascular Institute, Tokyo, Japan.'}, {'ForeName': 'Takuto', 'Initials': 'T', 'LastName': 'Arita', 'Affiliation': 'Department of Cardiovascular Medicine, The Cardiovascular Institute, Tokyo, Japan.'}, {'ForeName': 'Naoharu', 'Initials': 'N', 'LastName': 'Yagi', 'Affiliation': 'Department of Cardiovascular Medicine, The Cardiovascular Institute, Tokyo, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Otsuka', 'Affiliation': 'Department of Cardiovascular Medicine, The Cardiovascular Institute, Tokyo, Japan.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Kano', 'Affiliation': 'Department of Cardiovascular Medicine, The Cardiovascular Institute, Tokyo, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Matsuno', 'Affiliation': 'Department of Cardiovascular Medicine, The Cardiovascular Institute, Tokyo, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Semba', 'Affiliation': 'Department of Cardiovascular Medicine, The Cardiovascular Institute, Tokyo, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Kato', 'Affiliation': 'Department of Cardiovascular Medicine, The Cardiovascular Institute, Tokyo, Japan.'}, {'ForeName': 'Tokuhisa', 'Initials': 'T', 'LastName': 'Uejima', 'Affiliation': 'Department of Cardiovascular Medicine, The Cardiovascular Institute, Tokyo, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Oikawa', 'Affiliation': 'Department of Cardiovascular Medicine, The Cardiovascular Institute, Tokyo, Japan.'}, {'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Matsuhama', 'Affiliation': 'Department of Cardiovascular Surgery, The Cardiovascular Institute, Tokyo, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Yajima', 'Affiliation': 'Department of Cardiovascular Medicine, The Cardiovascular Institute, Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': 'Department of Cardiovascular Medicine, The Cardiovascular Institute, Tokyo, Japan.'}]",Journal of cardiology,['10.1016/j.jjcc.2020.12.007'] 1823,33387976,Preventing E-cigarette use among high-risk adolescents: A trauma-informed prevention approach.,"Exposure to childhood trauma increases the risk of tobacco use during adolescence. Recent studies have also reported potentially increased vulnerabilities to electronic cigarette (e-cigarette) use among youth with a history of childhood trauma. While empirical evidence supporting the relationship between childhood trauma and adolescent e-cigarette use is emerging, few effective preventive interventions are available to curb e-cigarette use among adolescent victims of childhood trauma. This article reviews current evidence with respect to how childhood trauma could increase risk for nicotine dependence and e-cigarette use in adolescent populations. Furthermore, this paper describes the development, design, and implementation of Rise Above (RA), a randomized, controlled trial of a trauma-informed, e-cigarette preventive intervention. Lessons learned are also discussed, including the challenges of implementing evidence-informed prevention work within communities vulnerable to traumatic events.",2021,Recent studies have also reported potentially increased vulnerabilities to electronic cigarette (e-cigarette) use among youth with a history of childhood trauma.,"['high-risk adolescents', 'youth with a history of childhood trauma']",[],[],"[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}]",[],[],,0.0156729,Recent studies have also reported potentially increased vulnerabilities to electronic cigarette (e-cigarette) use among youth with a history of childhood trauma.,"[{'ForeName': 'Sunny H', 'Initials': 'SH', 'LastName': 'Shin', 'Affiliation': 'Virginia Commonwealth University, School of Social Work, Richmond, VA, United States; Virginia Commonwealth University, School of Medicine, Department of Psychiatry, Richmond, VA, United States. Electronic address: sshin@vcu.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106795'] 1824,33385757,Examining the effects of problematic alcohol use on cigarette abstinence in recently diagnosed cancer patients enrolled in a cessation trial: A secondary analysis.,"AIMS Among people with cancer, dual alcohol and tobacco use increases risk for morbidity and mortality. Most smoking cessation clinical trials with this patient population have excluded individuals with problematic alcohol use. This investigation examined whether problematic alcohol use affects smoking cessation in cancer patients. METHODS Mixed-methods secondary analysis of data from the Smokefree Support Study, a randomized-controlled trial examining the efficacy of Intensive (IT; n = 153) vs. Standard Treatment (ST; n = 150) for smoking cessation in newly diagnosed cancer patients. Problematic alcohol use was assessed at enrollment using the Cut-Down-Annoyed-Guilty-Eye-Opener (CAGE), weekly frequency of alcohol use and binge drinking measures. Alcohol use was categorized as: no current alcohol use, moderate and problematic use. The primary outcome was biochemically-confirmed cigarette abstinence at 6-months. A subset of patients (n = 72) completed qualitative exit-interviews. RESULTS Among all participants, biochemically-confirmed cigarette abstinence rates were 25% (n = 32), 28% (n = 27), and 36% (n = 20) for participants reporting no current alcohol use, moderate use, and problematic use, respectively (p = 0.33). In logistic regression analysis, neither problematic alcohol use (AOR = 0.96, 95% CI = 0.35-2.67, p = .94) nor the problematic use by study arm interaction (AOR = 2.22, 95% CI = 0.59-8.39, p = .24) were associated with biochemically-confirmed 6-month abstinence. Qualitatively, participants reported that drinking alcohol triggers urges to smoke. CONCLUSION Newly diagnosed cancer patients reporting problematic alcohol use were not less likely to quit smoking than those without. Additional research is needed to investigate whether problematic alcohol users may benefit from smoking and alcohol behavior change interventions at the time of cancer diagnosis.",2021,"In logistic regression analysis, neither problematic alcohol use (AOR = 0.96, 95% CI = 0.35-2.67, p = .94) nor the problematic use by study arm interaction (AOR = 2.22, 95% CI = 0.59-8.39, p = .24) were associated with biochemically-confirmed 6-month abstinence.","['people with cancer', 'Newly diagnosed cancer patients', 'cancer patients', 'newly diagnosed cancer patients', 'recently diagnosed cancer patients enrolled in a cessation trial']","['problematic alcohol', 'Intensive (IT; n\xa0=\xa0153) vs. Standard Treatment (ST; n\xa0']","['morbidity and mortality', 'cigarette abstinence rates', 'quit smoking', 'biochemically-confirmed cigarette abstinence', 'cigarette abstinence']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]",,0.0628504,"In logistic regression analysis, neither problematic alcohol use (AOR = 0.96, 95% CI = 0.35-2.67, p = .94) nor the problematic use by study arm interaction (AOR = 2.22, 95% CI = 0.59-8.39, p = .24) were associated with biochemically-confirmed 6-month abstinence.","[{'ForeName': 'Joanna M', 'Initials': 'JM', 'LastName': 'Streck', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital (MGH), Boston, MA, United States; Harvard Medical School, Boston, MA, United States; Tobacco Research and Treatment Center, Department of Medicine and Health Policy Research Center, The Mongan Institute, MGH, Boston, MA, United States. Electronic address: jstreck@mgh.harvard.edu.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Hyland', 'Affiliation': 'Department of Psychology, University of Southern Florida, Tampa, FL, United States.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Regan', 'Affiliation': 'Harvard Medical School, Boston, MA, United States; Tobacco Research and Treatment Center, Department of Medicine and Health Policy Research Center, The Mongan Institute, MGH, Boston, MA, United States.'}, {'ForeName': 'Alona', 'Initials': 'A', 'LastName': 'Muzikansky', 'Affiliation': 'MGH Center for Biostatistics, Boston, MA, United States.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Rigotti', 'Affiliation': 'Harvard Medical School, Boston, MA, United States; Tobacco Research and Treatment Center, Department of Medicine and Health Policy Research Center, The Mongan Institute, MGH, Boston, MA, United States.'}, {'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'Ponzani', 'Affiliation': 'Tobacco Research and Treatment Center, Department of Medicine and Health Policy Research Center, The Mongan Institute, MGH, Boston, MA, United States.'}, {'ForeName': 'Giselle K', 'Initials': 'GK', 'LastName': 'Perez', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital (MGH), Boston, MA, United States; Harvard Medical School, Boston, MA, United States; Tobacco Research and Treatment Center, Department of Medicine and Health Policy Research Center, The Mongan Institute, MGH, Boston, MA, United States.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Kalkhoran', 'Affiliation': 'Harvard Medical School, Boston, MA, United States; Tobacco Research and Treatment Center, Department of Medicine and Health Policy Research Center, The Mongan Institute, MGH, Boston, MA, United States.'}, {'ForeName': 'Jamie S', 'Initials': 'JS', 'LastName': 'Ostroff', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY, United States.'}, {'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital (MGH), Boston, MA, United States; Harvard Medical School, Boston, MA, United States; Tobacco Research and Treatment Center, Department of Medicine and Health Policy Research Center, The Mongan Institute, MGH, Boston, MA, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106794'] 1825,33393175,"Botulinum toxin injection into the intrinsic laryngeal muscles to treat spasmodic dysphonia: A multicenter, placebo-controlled, randomized, double-blinded, parallel-group comparison/open-label clinical trial.","BACKGROUND AND PURPOSE Botulinum toxin (BT) injection into the laryngeal muscles has been a standard treatment for spasmodic dysphonia (SD). However, few high-quality clinical studies have appeared, and BT is used off-label in most countries. METHODS We performed a multicenter, placebo-controlled, randomized, double-blinded, parallel-group comparison/open-label clinical trial to obtain approval for BT (Botox) therapy in Japan. Twenty-four patients (22 with adductor SD and two with abductor SD) were enrolled. The primary end point was the change in the number of aberrant morae (phonemes) at 4 weeks after drug injection. The secondary end points included the change in the number of aberrant morae, GRBAS scale, Voice Handicap Index (VHI), and visual analog scale (VAS) over the entire study period. RESULTS In the adductor SD group, the number of aberrant morae at 4 weeks after injection was reduced by 7.0 ± 2.30 (mean ± SE) in the BT group and 0.2 ± 0.46 in the placebo group (p = 0.0148). The improvement persisted for 12 weeks following BT injections. The strain element in GRBAS scale significantly reduced at 2 weeks after BT treatment. The VHI and VAS scores as subjective parameters also improved. In the abductor SD group, one patient responded to treatment. Adverse events included breathy hoarseness (77.3%) and aspiration when drinking (40.9%) but were mild and resolved in 4 weeks. CONCLUSIONS Botulinum toxin injection was safe and efficacious for the treatment of SD. Based on these results, BT injection therapy was approved as an SD treatment in Japan.",2021,"Adverse events included breathy hoarseness (77.3%) and aspiration when drinking (40.9%) but were mild and resolved in 4 weeks. ","['Twenty-four patients (22 with adductor SD and 2 with abductor SD', 'intrinsic laryngeal muscles to treat spasmodic dysphonia', 'Japan']","['BT (Botox ® ) therapy', 'placebo', 'Botulinum toxin injection', 'Botulinum toxin (BT) injection', 'BT injection', 'BT injection therapy']","['VHI and VAS scores', 'breathy hoarseness', 'change in the number of aberrant morae (phonemes', 'number of aberrant morae', 'change in the number of aberrant morae, GRBAS scale, Voice Handicap Index (VHI) and visual analogue scale (VAS', 'GRBAS scale']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0264589', 'cui_str': 'Adductor spastic dysphonia'}, {'cui': 'C0264597', 'cui_str': 'Abductor spastic dysphonia'}, {'cui': 'C0225580', 'cui_str': 'Structure of intrinsic laryngeal muscle'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0264588', 'cui_str': 'Spastic dysphonia'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0006055', 'cui_str': 'botulinum toxin'}, {'cui': 'C0700702', 'cui_str': 'Botox'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1321035', 'cui_str': 'Injection of botulinum toxin'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C2985106', 'cui_str': 'Voice handicap index'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0451192', 'cui_str': 'GRBAS scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",24.0,0.471636,"Adverse events included breathy hoarseness (77.3%) and aspiration when drinking (40.9%) but were mild and resolved in 4 weeks. ","[{'ForeName': 'Masamitsu', 'Initials': 'M', 'LastName': 'Hyodo', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Kochi University, Nankoku, Japan.'}, {'ForeName': 'Asuka', 'Initials': 'A', 'LastName': 'Nagao', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Kochi University, Nankoku, Japan.'}, {'ForeName': 'Kento', 'Initials': 'K', 'LastName': 'Asano', 'Affiliation': 'Department of Medical Innovation, Osaka University Hospital, Suita, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Sakaguchi', 'Affiliation': 'Department of Engineering Informatics, Osaka Electro Communication University, Neyagawa, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Mizoguchi', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Omori', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Tada', 'Affiliation': 'Department of Otolaryngology, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Hiromitsu', 'Initials': 'H', 'LastName': 'Hatakeyama', 'Affiliation': 'Department of Otolaryngology, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Oridate', 'Affiliation': 'Department of Otolaryngology, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Kensei', 'Initials': 'K', 'LastName': 'Naito', 'Affiliation': 'Academy of Nursing, Fujita Health University, Toyoake, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Iwata', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Fujita Health University, Toyoake, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Shinomiya', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Kobe University, Kobe.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Otolaryngology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Tetsuji', 'Initials': 'T', 'LastName': 'Sanuki', 'Affiliation': 'Department of Otolaryngology, Nagoya City University, Nagoya, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Yumoto', 'Affiliation': 'Department of Otolaryngology, Kumamoto University, Kumamoto, Japan.'}]",European journal of neurology,['10.1111/ene.14714'] 1826,33392946,Comparison of home-based pencil push-up therapy and office-based orthoptic therapy in symptomatic patients of convergence insufficiency: a randomized controlled trial.,"PURPOSE To assess and compare the effectiveness of home-based pencil push-up therapy (PPT) and office-based orthoptic therapy (OBOT) in patients with convergence insufficiency. METHODS In this randomized clinical trial, 176 symptomatic patients with convergence insufficiency, aged between 9 to 30 years, were randomly assigned to receive 6 weeks of home-based PPT (Group I) or OBOT (Group II) after determining refractive error, near point of convergence (NPC), convergence insufficiency symptom survey (CISS) score, near phoria and positive fusional vergences (PFV) at near. The participants of Group I underwent home-based PPT (pencil push-ups exercises15 minutes per day, daily for 6 weeks) and those of Group II OBOT (convergence fusional exercises on synoptophore for 20 min per day, 3 days a week, for 6 weeks) without home reinforcement. Patients were re-examined at 3 and 6 weeks after initiation of treatment. NPC and CISS score were the primary and secondary outcome measures, respectively. Statistical analysis was performed with the independent samples t-test, Friedman test and the analysis of variance (ANOVA). Statistical significance was indicated by p-value < 0.05. RESULTS Participants of both the groups had statistically significant improvement in NPC, CISS score, PFV and near phoria (p < 0.001), but there was no statistically significant difference between the two groups (p > 0.05). However, patients of Group II had significantly better PFV after final visit than those of Group I (p < 0.001). CONCLUSION Home-based PPT with good suppression control and with compliance ensured by log book entries, is a simple, cheap, less time consuming and comparably effective alternative to more expensive OBOT for patients suffering from CI. CTRI registration number: REF/2016/11/012,732, Date of registration 25/04/ 2016, Retrospectively Registered.",2021,"RESULTS Participants of both the groups had statistically significant improvement in NPC, CISS score, PFV and near phoria (p < 0.001), but there was no statistically significant difference between the two groups (p > 0.05).","['patients with convergence insufficiency', 'symptomatic patients of convergence insufficiency', '176 symptomatic patients with convergence insufficiency, aged between 9 to 30\xa0years']","['home-based PPT (pencil push-ups exercises15 minutes per day, daily for 6\xa0weeks) and those of Group II OBOT (convergence fusional exercises on synoptophore', 'home-based pencil push-up therapy (PPT) and office-based orthoptic therapy (OBOT', 'home-based PPT (Group I) or OBOT', 'home-based pencil push-up therapy and office-based orthoptic therapy']","['NPC, CISS score, PFV and near phoria', 'convergence insufficiency symptom survey (CISS) score, near phoria and positive fusional vergences (PFV', 'PFV', 'NPC and CISS score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271379', 'cui_str': 'Convergence insufficiency'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0441059', 'cui_str': 'Pencil'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0029362', 'cui_str': 'Pleoptics'}, {'cui': 'C0443193', 'cui_str': 'Convergence'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441843', 'cui_str': 'Group I'}]","[{'cui': 'C0429572', 'cui_str': 'Ocular accommodation near point'}, {'cui': 'C0443193', 'cui_str': 'Convergence'}, {'cui': 'C0271379', 'cui_str': 'Convergence insufficiency'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0038379', 'cui_str': 'Strabismus'}]",176.0,0.107986,"RESULTS Participants of both the groups had statistically significant improvement in NPC, CISS score, PFV and near phoria (p < 0.001), but there was no statistically significant difference between the two groups (p > 0.05).","[{'ForeName': 'Anupam', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Ophthalmology Department, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, 249203, India. dr.anupamsingh@gmail.com.'}, {'ForeName': 'Vartika', 'Initials': 'V', 'LastName': 'Saxena', 'Affiliation': 'Department of Community and Family Medicine, All India Institute of Medical Sciences, Rishikesh, India.'}, {'ForeName': 'Sandhya', 'Initials': 'S', 'LastName': 'Yadav', 'Affiliation': 'Ophthalmology Department, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, 249203, India.'}, {'ForeName': 'Ajai', 'Initials': 'A', 'LastName': 'Agrawal', 'Affiliation': 'Ophthalmology Department, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, 249203, India.'}, {'ForeName': 'Achala', 'Initials': 'A', 'LastName': 'Ramawat', 'Affiliation': 'Ophthalmology Department, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, 249203, India.'}, {'ForeName': 'Ramanuj', 'Initials': 'R', 'LastName': 'Samanta', 'Affiliation': 'Ophthalmology Department, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, 249203, India.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Panyala', 'Affiliation': 'Ophthalmology Department, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, 249203, India.'}, {'ForeName': 'Barun', 'Initials': 'B', 'LastName': 'Kumar', 'Affiliation': 'Department of Cardiology, All India Institute of Medical Sciences, Rishikesh, India.'}]",International ophthalmology,['10.1007/s10792-020-01689-7'] 1827,33392944,Transscleral cyclophotocoagulation with MicroPulse ® laser versus Ahmed valve implantation in patients with advanced primary open-angle glaucoma.,"PURPOSE To compare the efficacy of transscleral cyclophotocoagulation with MicroPulse ® laser (Iridex, Silicon Valley, California, USA) with 3000 mW to Ahmed valve implantation in eyes with advanced stage of primary open-angle glaucoma. METHODS In a prospective observational clinical study, 30 patients (30 eyes) with advanced open-angle glaucoma were randomized for either micropulse transscleral cyclophotocoagulation with 3000 mW or Ahmed valve implantation. Fifteen eyes were treated with transscleral cyclophotocoagulation with MicroPulse ® laser with 3000 mW (group A) and 15 eyes with Ahmed valve implantation (group B). As inclusion criteria are included the diagnosis of advanced primary open-angle glaucoma, an intraocular pressure above 21 mmHg, cup-to-disk ratio 0.9-1.0, failure to meet the target IOP with either maximal tolerated local medical therapy (2-4 antiglaucoma agents) or systemic therapy (acetazolamide). The follow-up time of the study was 12 months. An absolute success was defined the achievement of IOP between 6 and 15 mmHg and at least 30% reduction of the IOP from baseline under reduced or the same number of antiglaucoma agents after the surgical procedure without following glaucoma surgeries and as qualified success the achievement of IOP between 6 and 18 mmHg and at least 20% reduction of the IOP from baseline regardless of the number of postoperative antiglaucoma agents. The efficacy was evaluated by estimating the absolute success rate and the qualified success rate using the Kaplan-Meier survival analysis. RESULTS A reduction of the intraocular pressure > 30% was achieved in 33.3% of group A and in 73.3% of group B during the follow-up period of 12 months. A statistically significant decrease in the number of eye drops was observed in both groups (p < 0.01). 53.3% of the eyes of group A underwent additional anti-glaucoma procedures to achieve target intraocular pressure. The number of the local medications that were administered 12 months after the ocular surgery was 2 (± 1.3) in group A and 0.57 (± 0.9) in group B, compared to 3.2 (± 0.78) in group A and 3.33 (± 0.7) in group B administered prior to the surgery (p: 0.016). 8 eyes (53.33%) in group A were referred for additional treatment due to an acute postoperative rise in IOP (5 eyes: mTS-CPC, 1 eye: canaloplasty, 2 eyes: AGV implantation). No further anti-glaucoma procedures were necessary in group B. CONCLUSION The Ahmed valve implantation achieves a more efficient decrease of the intraocular pressure as well as of the number of antiglaucoma agents than the transscleral cyclophotocoagulation with MicroPulse ® diode laser 3000 mW. Additionally, the Ahmed valve implantation showed better results in terms of absolute and qualified success rates in the treatment of advanced primary open-angle glaucoma.",2021,"The efficacy was evaluated by estimating the absolute success rate and the qualified success rate using the Kaplan-Meier survival analysis. ","['patients with advanced primary open-angle glaucoma', 'Fifteen eyes were treated with', 'As inclusion criteria are included the diagnosis of advanced primary open-angle glaucoma, an intraocular pressure above 21\xa0mmHg, cup-to-disk ratio 0.9-1.0, failure to meet the target IOP with either maximal tolerated local medical therapy (2-4 antiglaucoma agents) or', 'eyes with advanced stage of primary open-angle glaucoma', '30 patients (30 eyes) with advanced open-angle glaucoma']","['systemic therapy (acetazolamide', 'transscleral cyclophotocoagulation with MicroPulse ® laser with 3000\xa0mW (group A) and 15 eyes with Ahmed valve implantation', 'MicroPulse ® diode laser 3000', 'transscleral cyclophotocoagulation with MicroPulse ® laser (Iridex, Silicon Valley, California, USA) with 3000\xa0mW to Ahmed valve implantation', 'micropulse transscleral cyclophotocoagulation with 3000\xa0mW or Ahmed valve implantation', 'Transscleral cyclophotocoagulation with MicroPulse ® laser versus Ahmed valve implantation']","['number of the local medications', 'intraocular pressure', 'absolute and qualified success rates', 'number of eye drops']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C1515995', 'cui_str': 'Antiglaucoma agent'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0311339', 'cui_str': 'Advanced open-angle glaucoma'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0000981', 'cui_str': 'Acetazolamide'}, {'cui': 'C0395490', 'cui_str': 'Photocoagulation of ciliary body'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1444577', 'cui_str': 'Ahmed tube shunt'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0037107', 'cui_str': 'Silicon'}, {'cui': 'C0563004', 'cui_str': 'Valley'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}]",15.0,0.0373784,"The efficacy was evaluated by estimating the absolute success rate and the qualified success rate using the Kaplan-Meier survival analysis. ","[{'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Fili', 'Affiliation': 'Clinic of Ophthalmology, St. Johannes Hospital in Dortmund, Johannesstraße 9-13, 44137, Dortmund, Germany. sofia.fili@joho-dortmund.de.'}, {'ForeName': 'Kalliopi', 'Initials': 'K', 'LastName': 'Kontopoulou', 'Affiliation': 'Clinic of Ophthalmology, St. Johannes Hospital in Dortmund, Johannesstraße 9-13, 44137, Dortmund, Germany.'}, {'ForeName': 'Iraklis', 'Initials': 'I', 'LastName': 'Vastardis', 'Affiliation': 'Clinic of Ophthalmology Pallas, Zurich, Switzerland.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Perdikakis', 'Affiliation': 'Clinic of Ophthalmology, St. Johannes Hospital in Dortmund, Johannesstraße 9-13, 44137, Dortmund, Germany.'}, {'ForeName': 'Styliani Alexia', 'Initials': 'SA', 'LastName': 'Papadonta', 'Affiliation': 'Clinic of Ophthalmology, St. Johannes Hospital in Dortmund, Johannesstraße 9-13, 44137, Dortmund, Germany.'}, {'ForeName': 'Eleni Zaira', 'Initials': 'EZ', 'LastName': 'Armeni', 'Affiliation': 'Clinic of Ophthalmology, St. Johannes Hospital in Dortmund, Johannesstraße 9-13, 44137, Dortmund, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Kohlhaas', 'Affiliation': 'Clinic of Ophthalmology, St. Johannes Hospital in Dortmund, Johannesstraße 9-13, 44137, Dortmund, Germany.'}]",International ophthalmology,['10.1007/s10792-020-01682-0'] 1828,33388532,Image quality and safety of automated carbon dioxide digital subtraction angiography in femoropopliteal lesions: Results from a randomized single-center study.,"PURPOSE To evaluate the image quality and the safety of automated carbon dioxide (CO 2 ) digital subtraction angiography (DSA). MATERIALS AND METHODS Fifty patients receiving DSA for femoropopliteal peripheral arterial disease (PAD) were enrolled in this single-center prospective study. All patients received iodinated contrast media (ICM) and CO 2 as a contrast agent in the same target lesion. As a primary endpoint, four raters independently evaluated the angiography images based on overall image quality, visibility of collaterals, and assessment of stenoses/occlusions. Inter-rater agreement was assessed using the intraclass correlation coefficient (ICC) and differences between the raters were evaluated using Friedmann's test. Secondary endpoints were procedure safety and patient pain assessment. RESULTS Inter-rater agreement between CO 2 -DSA and ICM-DSA images was fair to excellent for overall image quality (ICC: 0.399-0.748), fair to excellent for the visibility of collaterals (ICC: 0.513-0.691), and poor to excellent for the assessment of stenoses/occlusions (ICC: -0.065-0.762). There were no significant differences between the raters. Two patients had a hematoma, one reported pain related to puncture, one became nauseous, and one vomited. No other adverse events were observed. Reported pain scores were significantly higher for CO 2 -DSA vs. ICM-DSA (1.25 vs. 0625; p < 0.028). CONCLUSION CO2-DSA using automated injection system in combination with proprietary post-processing software is safe and comparable diagnostic test compared to ICM-DSA.",2021,"Reported pain scores were significantly higher for CO 2 -DSA vs. ICM-DSA (1.25 vs. 0625; p < 0.028). ","['femoropopliteal lesions', 'Fifty patients receiving DSA for femoropopliteal peripheral arterial disease (PAD']","['automated carbon dioxide (CO 2 ) digital subtraction angiography (DSA', 'iodinated contrast media (ICM', 'automated carbon dioxide digital subtraction angiography']","['Image quality and safety', 'procedure safety and patient pain assessment', 'adverse events', 'pain scores', 'overall image quality, visibility of collaterals, and assessment of stenoses/occlusions', 'overall image quality']","[{'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002979', 'cui_str': 'Digital subtraction angiography'}, {'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0002979', 'cui_str': 'Digital subtraction angiography'}, {'cui': 'C1960405', 'cui_str': 'Iodinated contrast media'}]","[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1269689', 'cui_str': 'Safety procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1275670', 'cui_str': 'Collateral branch of vessel'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}]",50.0,0.059742,"Reported pain scores were significantly higher for CO 2 -DSA vs. ICM-DSA (1.25 vs. 0625; p < 0.028). ","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Bürckenmeyer', 'Affiliation': 'Department for Diagnostic and Interventional Radiology, University Hospital Jena, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Schmidt', 'Affiliation': 'Department for Diagnostic and Interventional Radiology, University Hospital Jena, Germany.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Diamantis', 'Affiliation': 'Department for Diagnostic and Interventional Radiology, University Hospital Jena, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lehmann', 'Affiliation': 'Center for Clinical Studies, University Hospital Jena, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Malouhi', 'Affiliation': 'Department for Diagnostic and Interventional Radiology, University Hospital Jena, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Franiel', 'Affiliation': 'Department for Diagnostic and Interventional Radiology, University Hospital Jena, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Zanow', 'Affiliation': 'Clinic for General, Visceral and Vascular Surgery, University Hospital Jena, Germany.'}, {'ForeName': 'U K M', 'Initials': 'UKM', 'LastName': 'Teichgräber', 'Affiliation': 'Department for Diagnostic and Interventional Radiology, University Hospital Jena, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Aschenbach', 'Affiliation': 'Department for Diagnostic and Interventional Radiology, University Hospital Jena, Germany. Electronic address: rene.aschenbach@med.uni-jena.de.'}]",European journal of radiology,['10.1016/j.ejrad.2020.109476'] 1829,33400390,"Umbilical cord mesenchymal stem cells for COVID-19 acute respiratory distress syndrome: A double-blind, phase 1/2a, randomized controlled trial.","Acute respiratory distress syndrome (ARDS) in COVID-19 is associated with high mortality. Mesenchymal stem cells are known to exert immunomodulatory and anti-inflammatory effects and could yield beneficial effects in COVID-19 ARDS. The objective of this study was to determine safety and explore efficacy of umbilical cord mesenchymal stem cell (UC-MSC) infusions in subjects with COVID-19 ARDS. A double-blind, phase 1/2a, randomized, controlled trial was performed. Randomization and stratification by ARDS severity was used to foster balance among groups. All subjects were analyzed under intention to treat design. Twenty-four subjects were randomized 1:1 to either UC-MSC treatment (n = 12) or the control group (n = 12). Subjects in the UC-MSC treatment group received two intravenous infusions (at day 0 and 3) of 100 ± 20 × 10 6 UC-MSCs; controls received two infusions of vehicle solution. Both groups received best standard of care. Primary endpoint was safety (adverse events [AEs]) within 6 hours; cardiac arrest or death within 24 hours postinfusion). Secondary endpoints included patient survival at 31 days after the first infusion and time to recovery. No difference was observed between groups in infusion-associated AEs. No serious adverse events (SAEs) were observed related to UC-MSC infusions. UC-MSC infusions in COVID-19 ARDS were found to be safe. Inflammatory cytokines were significantly decreased in UC-MSC-treated subjects at day 6. Treatment was associated with significantly improved patient survival (91% vs 42%, P = .015), SAE-free survival (P = .008), and time to recovery (P = .03). UC-MSC infusions are safe and could be beneficial in treating subjects with COVID-19 ARDS.",2021,"Treatment was associated with significantly improved patient survival (91% vs 42%, P = .015), SAE-free survival (P = .008), and time to recovery (P = .03).","['subjects with COVID-19 ARDS', 'COVID-19 acute respiratory distress syndrome', 'Twenty-four subjects']","['vehicle solution', 'Umbilical cord mesenchymal stem cells', 'UC-MSC', 'umbilical cord mesenchymal stem cell (UC-MSC']","['safety (adverse events [AEs]) within 6 hours; cardiac arrest or death within 24\u2009hours postinfusion', 'SAE-free survival', 'serious adverse events (SAEs', 'time to recovery', 'Inflammatory cytokines', 'Acute respiratory distress syndrome (ARDS', 'patient survival at 31\u2009days after the first infusion and time to recovery', 'patient survival']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C3715070', 'cui_str': '24'}]","[{'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0074299', 'cui_str': 'selenomethylselenocysteine'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1292428', 'cui_str': '6 hours'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]",24.0,0.523913,"Treatment was associated with significantly improved patient survival (91% vs 42%, P = .015), SAE-free survival (P = .008), and time to recovery (P = .03).","[{'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Lanzoni', 'Affiliation': 'Diabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Linetsky', 'Affiliation': 'Diabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Correa', 'Affiliation': 'Diabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Shari', 'Initials': 'S', 'LastName': 'Messinger Cayetano', 'Affiliation': 'Division of Biostatistics, Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Alvarez', 'Affiliation': 'Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Kouroupis', 'Affiliation': 'Diabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Alvarez Gil', 'Affiliation': 'Diabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Poggioli', 'Affiliation': 'Diabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Ruiz', 'Affiliation': 'Department of Surgery, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Marttos', 'Affiliation': 'Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Khemraj', 'Initials': 'K', 'LastName': 'Hirani', 'Affiliation': 'Diabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Crystal A', 'Initials': 'CA', 'LastName': 'Bell', 'Affiliation': 'Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Halina', 'Initials': 'H', 'LastName': 'Kusack', 'Affiliation': 'Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Rafkin', 'Affiliation': 'Diabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Baidal', 'Affiliation': 'Diabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Pastewski', 'Affiliation': 'Jackson Health System, Miami, Florida, USA.'}, {'ForeName': 'Kunal', 'Initials': 'K', 'LastName': 'Gawri', 'Affiliation': 'Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Clarissa', 'Initials': 'C', 'LastName': 'Leñero', 'Affiliation': 'Diabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Alejandro M A', 'Initials': 'AMA', 'LastName': 'Mantero', 'Affiliation': 'Division of Biostatistics, Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Sarah W', 'Initials': 'SW', 'LastName': 'Metalonis', 'Affiliation': 'Division of Biostatistics, Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Xiaojing', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Diabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Roque', 'Affiliation': 'Diabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Burlett', 'Initials': 'B', 'LastName': 'Masters', 'Affiliation': 'Diabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Norma S', 'Initials': 'NS', 'LastName': 'Kenyon', 'Affiliation': 'Diabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Ginzburg', 'Affiliation': 'Department of Surgery, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Xiumin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Diabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'Tan', 'Affiliation': ""The Second Affiliated Hospital of Hainan Medical University, Haikou, Hainan, People's Republic of China.""}, {'ForeName': 'Arnold I', 'Initials': 'AI', 'LastName': 'Caplan', 'Affiliation': 'Skeletal Research Center, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Marilyn K', 'Initials': 'MK', 'LastName': 'Glassberg', 'Affiliation': 'University of Arizona College of Medicine, Tucson, Arizona, USA.'}, {'ForeName': 'Rodolfo', 'Initials': 'R', 'LastName': 'Alejandro', 'Affiliation': 'Diabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Camillo', 'Initials': 'C', 'LastName': 'Ricordi', 'Affiliation': 'Diabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.'}]",Stem cells translational medicine,['10.1002/sctm.20-0472'] 1830,33399530,Effect of the Use of WeChat to Disseminate Preoperative Health Education to Parents of Children with Restrictive Ventricular Septal Defects: A Prospective Randomized Controlled Study.,"BACKGROUND This study explored the clinical effect of implementing WeChat-based preoperative health education for parents of children with restrictive ventricular septal defect. METHODS A prospective randomized controlled study was conducted in a provincial hospital on the southeast coast of China. Participants were randomly divided into an intervention (WeChat) group (n = 35) and a control group (leaflet) group (n = 35). The study explored the parents' knowledge of preoperative care, the follow-up rate, and complications of children with restrictive ventricular septal defect. RESULTS The score of preoperative care knowledge of the WeChat group (66.9 ± 3.5) was significantly higher than that of the leaflet group (47.3 ± 6.3) (P = .006). Compared with the score of care knowledge at the first visit, the score of the WeChat group at the preoperation was significantly higher (P < .05), whereas the increase in the score of the leaflet group was not significant. The rate of lost follow-up in the WeChat group (0%) was significantly lower than in the leaflet group (16.7%) (P = .02). The complications in the leaflet group were significantly higher than in the WeChat group. CONCLUSIONS Using WeChat to provide preoperative health education to parents of children with restrictive ventricular septal defect can effectively enhance the parents' knowledge of preoperative care and reduce the occurrence of complications and loss to follow-up.",2020,Using WeChat to provide preoperative health education to parents of children with restrictive ventricular septal defect can effectively enhance the parents' knowledge of preoperative care and reduce the occurrence of complications and loss to follow-up.,"['Parents of Children with Restrictive Ventricular Septal Defects', 'parents of children with restrictive ventricular septal defect', 'children with restrictive ventricular septal defect', 'provincial hospital on the southeast coast of China']","['WeChat', 'implementing WeChat-based preoperative health education']","['rate of lost follow', 'complications', 'score of preoperative care knowledge']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0344924', 'cui_str': 'Restrictive ventricular septal defect'}, {'cui': 'C3661820', 'cui_str': 'Provincial hospital'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033061', 'cui_str': 'Preoperative care'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",35.0,0.0179882,Using WeChat to provide preoperative health education to parents of children with restrictive ventricular septal defect can effectively enhance the parents' knowledge of preoperative care and reduce the occurrence of complications and loss to follow-up.,"[{'ForeName': 'Qiliang', 'Initials': 'QL', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China. zhangqiliang2020@163.com.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China. xuning2014@126.com.'}, {'ForeName': 'Shuting', 'Initials': 'ST', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China. hshuting2014@163.com.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiovascular Surgery, Union Hospital, Fujian Medical University, Fuzhou, China. chenqiang2228@163.com.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China. caohua0791@163.com.'}]",The heart surgery forum,['10.1532/hsf.3323'] 1831,33398936,Changes in Electroencephalogram Coherence in Adolescents With Autism Spectrum Disorder After a Social Skills Intervention.,"Autism spectrum disorder (ASD) is a developmental condition that affects social communication and behavior. There is consensus that neurological differences are present in ASD. Further, theories emphasize the mixture of hypo- and hyper-connectivity as a neuropathologies in ASD [O'Reilly, Lewis, & Elsabbagh, 2017]; however, there is a paucity of studies specifically testing neurological underpinnings as predictors of success on social skills interventions. This study examined functional neural connectivity (electroencephalogram [EEG], coherence) of adolescents with ASD before and after the Program for the Education and Enrichment of Relational Skills (PEERS®) intervention, using a randomized controlled trial of two groups: an Experimental ASD (EXP) Group and a Waitlist Control ASD (WL) Group. The study had two purposes. First, the study aimed to determine whether changes in EEG coherence differed for adolescents that received PEERS® versus those that did not receive PEERS®. Results revealed a significant increase in connectivity in the occipital left to temporal left pair for the EXP group after intervention. Second, the study aimed to determine if changes in EEG coherence related to changes in behavior, friendships, and social skills measured by questionnaires. At post-intervention, results indicated: (a) positive change in frontal right to parietal right coherence was linked to an increase in social skills scores; and (b) positive changes in occipital right to temporal right coherence and occipital left to parietal left coherence were linked to an increase in the total number of get-togethers. Results of this study support utilizing neurobehavioral domains as indicators of treatment outcome. Lay Summary: This study examined how well various areas of the brain communicate in adolescents with ASD before and after a social skills intervention. Results revealed increased connectivity in the adolescents that received the intervention. Secondly, the study aimed to determine if changes in connectivity of brain areas related to changes in behavior, friendships, and social skills. Results indicated that changes in connectivity were also linked to increased social skills. Autism Res 2021, 14: 787-803. © 2021 International Society for Autism Research and Wiley Periodicals LLC.",2021,Results revealed a significant increase in connectivity in the occipital left to temporal left pair for the EXP group after intervention.,"['Adolescents With Autism', 'adolescents with ASD before and after a social skills intervention', 'Spectrum Disorder', 'Autism spectrum disorder (ASD', 'adolescents with ASD']","['PEERS®', 'Experimental ASD (EXP) Group and a Waitlist Control ASD (WL', 'Relational Skills (PEERS®) intervention']","['EEG coherence', 'Electroencephalogram Coherence', 'positive change in frontal right to parietal right coherence', 'social skills', 'social skills scores; and (b) positive changes in occipital right to temporal right coherence and occipital left to parietal left coherence', 'behavior, friendships, and social skills', 'connectivity', 'total number of get-togethers']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0178647', 'cui_str': 'Friendship'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.0179511,Results revealed a significant increase in connectivity in the occipital left to temporal left pair for the EXP group after intervention.,"[{'ForeName': 'Angela D', 'Initials': 'AD', 'LastName': 'Haendel', 'Affiliation': 'Department of Speech-Language Pathology, Concordia University Wisconsin, Grafton, Wisconsin, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Barrington', 'Affiliation': 'Department of Biomedical Engineering, Marquette University, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Magnus', 'Affiliation': 'Department of Psychology, Boston College, Boston, Massachusetts, USA.'}, {'ForeName': 'Alexis A', 'Initials': 'AA', 'LastName': 'Arias', 'Affiliation': 'Department of Psychology, Marquette University, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'McVey', 'Affiliation': 'Department of Psychology, Marquette University, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Sheryl', 'Initials': 'S', 'LastName': 'Pleiss', 'Affiliation': 'Great Lakes Neurobehavioral Center, Edina, Minnesota, USA.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Carson', 'Affiliation': 'Independent Scholar, Houston, Texas, USA.'}, {'ForeName': 'Elisabeth M', 'Initials': 'EM', 'LastName': 'Vogt', 'Affiliation': 'Medical College of Wisconsin, Neurology, Wauwatosa, Wisconsin, USA.'}, {'ForeName': 'Amy Vaughan', 'Initials': 'AV', 'LastName': 'Van Hecke', 'Affiliation': 'Department of Psychology, Marquette University, Milwaukee, Wisconsin, USA.'}]",Autism research : official journal of the International Society for Autism Research,['10.1002/aur.2459'] 1832,33402419,Effect of erenumab on functional outcomes in patients with episodic migraine in whom 2-4 preventives were not useful: results from the LIBERTY study.,"OBJECTIVE To evaluate the effect of erenumab on patient-reported, functional outcomes in patients with episodic migraine (EM) in whom 2-4 preventives were not useful from the Phase 3b LIBERTY study. METHODS As previously reported, 246 patients with EM with 2-4 prior failed preventives were randomised 1:1 to subcutaneous erenumab 140 mg or placebo every 4 weeks for 12 weeks. This analysis evaluated Migraine Physical Function Impact Diary (MPFID), Headache Impact Test (HIT-6) and Work Productivity and Activity Impairment (WPAI) scores at Week 12. P values were nominal without multiplicity adjustment. RESULTS Erenumab significantly improved MPFID-Physical Impairment (PI) and Everyday Activities (EA) scores versus placebo (treatment difference (TD) (95% CI) MPFID-PI: -3.5 (-5.7 to -1.2) (p=0.003); MPFID-EA: -3.9 (-6.1 to -1.7)) (p<0.001) at 12 weeks. Patients on erenumab were more likely to have a ≥5-point reduction in MPFID score (OR vs placebo (95% CI) MPFID-EA: 2.1 (1.2 to 3.6); MPFID-PI: 2.5 (1.4 to 4.5)). A similar trend was observed for HIT-6 (TD: -3.0; p<0.001); significantly higher proportions of patients on erenumab reported a ≥5-point reduction (OR (95% CI): 2.4 (1.4 to 4.1)). In three out of four WPAI domains, erenumab showed improvement versus placebo. CONCLUSION At 12 weeks, erenumab was efficacious on functional outcomes in patients with EM in whom 2-4 preventives were not useful. TRIAL REGISTRATION DETAILS ClinicalTrials.gov identifier: NCT03096834.",2021,"RESULTS Erenumab significantly improved MPFID-Physical Impairment (PI) and Everyday Activities (EA) scores versus placebo (treatment difference (TD) (95% CI) MPFID-PI: -3.5 (-5.7 to -1.2) (p=0.003);","['patients with episodic migraine (EM) in whom 2-4 preventives were not useful from the Phase 3b LIBERTY study', 'patients with episodic migraine in whom 2-4 preventives were not useful: results from the LIBERTY study', '246 patients with EM with 2-4 prior failed preventives']","['placebo', 'erenumab', 'MPFID-EA', 'subcutaneous erenumab 140\u2009mg or placebo', 'TD']","['MPFID score', 'HIT-6', 'functional outcomes', 'Migraine Physical Function Impact Diary (MPFID), Headache Impact Test (HIT-6) and Work Productivity and Activity Impairment (WPAI) scores', 'MPFID-Physical Impairment (PI) and Everyday Activities (EA) scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4542165', 'cui_str': 'erenumab'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4319553', 'cui_str': '140'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0231171', 'cui_str': 'Physical impairment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",246.0,0.26669,"RESULTS Erenumab significantly improved MPFID-Physical Impairment (PI) and Everyday Activities (EA) scores versus placebo (treatment difference (TD) (95% CI) MPFID-PI: -3.5 (-5.7 to -1.2) (p=0.003);","[{'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Lanteri-Minet', 'Affiliation': 'Pain Department and FHU InovPain, CHU Nice - Côte Azur Université, Nice, France lanteri-minet.m@chu-nice.fr.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""King's College London, NIHR/Wellcome Trust King's CRF, London, London, UK.""}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Reuter', 'Affiliation': 'Department of Neurology, Charite Universitatsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Shihua', 'Initials': 'S', 'LastName': 'Wen', 'Affiliation': 'Novartis Pharmaceuticals Corp, East Hanover, New Jersey, USA.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Hours-Zesiger', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Michel D', 'Initials': 'MD', 'LastName': 'Ferrari', 'Affiliation': 'Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Klatt', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2020-324396'] 1833,33819066,"In eosinophilic esophagitis, budesonide orodispersible tablets maintained remission at 48 wk.","SOURCE CITATION Straumann A, Lucendo AJ, Miehlke S, et al. Budesonide orodispersible tablets maintain remission in a randomized, placebo-controlled trial of patients with eosinophilic esophagitis. Gastroenterology. 2020;159:1672-85. 32721437.",2021,"Budesonide orodispersible tablets maintain remission in a randomized, placebo-controlled trial of patients with eosinophilic esophagitis. ",['patients with eosinophilic esophagitis'],"['Budesonide orodispersible tablets', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0341106', 'cui_str': 'Eosinophilic esophagitis'}]","[{'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C2960508', 'cui_str': 'Orodispersible tablet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.225222,"Budesonide orodispersible tablets maintain remission in a randomized, placebo-controlled trial of patients with eosinophilic esophagitis. ","[{'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Srinivasan', 'Affiliation': 'University of Kansas Medical Center and Kansas City Veteran Affairs Medical Center, Kansas City, Kansas, USA (S.S., P.S.).'}, {'ForeName': 'Prateek', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'University of Kansas Medical Center and Kansas City Veteran Affairs Medical Center, Kansas City, Kansas, USA (S.S., P.S.).'}]",Annals of internal medicine,['10.7326/ACPJ202104200-044'] 1834,33819062,"In statin-treated patients at high CV risk, adding omega-3 fatty acidsvs. corn oil to usual care did not reduce MACE.","SOURCE CITATION Nicholls SJ, Lincoff AM, Garcia M, et al. Effect of high-dose omega-3 fatty acids vs corn oil on major adverse cardiovascular events in patients at high cardiovascular risk: the STRENGTH randomized clinical trial. JAMA. 2020;324:2268-80. 33190147.",2021,Effect of high-dose omega-3 fatty acids vs corn oil on major adverse cardiovascular events in patients at high cardiovascular risk,['patients at high cardiovascular risk'],['high-dose omega-3 fatty acids vs corn oil'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0010029', 'cui_str': 'Corn Oil'}]",[],,0.100065,Effect of high-dose omega-3 fatty acids vs corn oil on major adverse cardiovascular events in patients at high cardiovascular risk,"[{'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Budenholzer', 'Affiliation': 'Private practice, Virginia Beach, Virginia, United States (B.B.).'}]",Annals of internal medicine,['10.7326/ACPJ202104200-040'] 1835,33484934,Therapeutic role of enoxaparin in intra-uterine growth restriction: A randomized clinical trial.,"OBJECTIVE Intrauterine growth restriction is a leading cause of perinatal mortality and morbidity. Using enoxaparin may enhance the placental circulation and improve the intrauterine growth. This study was conducted to assess the efficacy and safety of enoxaparin in treatment of intra-uterine growth restriction. STUDY DESIGN 125 women with intrauterine growth restriction were randomized to control group and intervention group (receiving routine high risk pregnancy prenatal care plus daily subcutaneous injection of 40 mg enoxaparin). Prolongation of pregnancy, fetal birth weight, fetal outcome and enoxaparin side effects were compared in 2 groups. RESULTS Baseline characteristics were similar in 2 groups. Mean gestational age at delivery was 36.73(±2.71) in enoxaparin group and 36.85(±2.17) in control group which showed no statistically significant difference. Mean fetal birth weight had also no statistically significant difference in enoxaparin and control group (2370.16 ± 580.72 g versus 2456.07 ± 543.06 g). Rate of betamethasone administration, intubation, NICU admission, sepsis, necrotizing enterocolitis, intra-ventricular hemorrhage, hypoglycemia and low apgar score were similar in two groups. No major adverse effect was seen. CONCLUSION Enoxaparin did not prolong the pregnancy and fetal birth weight and did not improve the fetal outcome even in patients with impaired baseline Doppler findings.",2021,Enoxaparin did not prolong the pregnancy and fetal birth weight and did not improve the fetal outcome even in patients with impaired baseline Doppler findings.,"['Intra-uterine Growth Restriction', '125 women with intrauterine growth restriction']","['Enoxaparin', 'control group and intervention group (receiving routine high risk pregnancy prenatal care plus daily subcutaneous injection of 40\u2009mg enoxaparin', 'enoxaparin']","['pregnancy and fetal birth weight', 'placental circulation', 'Prolongation of pregnancy, fetal birth weight, fetal outcome and enoxaparin side effects', 'efficacy and safety', 'Mean gestational age at delivery', 'Mean fetal birth weight', 'Rate of betamethasone administration, intubation, NICU admission, sepsis, necrotizing enterocolitis, intra-ventricular hemorrhage, hypoglycemia and low apgar score']","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015934', 'cui_str': 'Fetal growth restriction'}]","[{'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0242786', 'cui_str': 'High risk pregnancy'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}]","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0887803', 'cui_str': 'Circulation, Placental'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}]",125.0,0.0817995,Enoxaparin did not prolong the pregnancy and fetal birth weight and did not improve the fetal outcome even in patients with impaired baseline Doppler findings.,"[{'ForeName': 'Mahboobeh', 'Initials': 'M', 'LastName': 'Shirazi', 'Affiliation': 'Maternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences, Yas Hospital Complex, District 7, N Villa Rd, Tehran, Iran. Electronic address: Mahboobehshirazi4@gmail.com.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Naeiji', 'Affiliation': 'Department of Gynecology and Obstetrics, Shahid Beheshti University of Medical Sciences, Mahdiye Hospital, Shishegar Khane St., Fadayian Eslam Blv. Shoosh Sq., 1445763693, Tehran, Iran. Electronic address: Zahranaeiji98@yahoo.com.'}, {'ForeName': 'Fatemeh Rahimi', 'Initials': 'FR', 'LastName': 'Sharbaf', 'Affiliation': 'Maternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences, Yas Hospital Complex, District 7, N Villa Rd, Tehran, Iran. Electronic address: rahimish@sina.tums.ac.ir.'}, {'ForeName': 'Fateme', 'Initials': 'F', 'LastName': 'Golshahi', 'Affiliation': 'Maternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences, Yas Hospital Complex, District 7, N Villa Rd, Tehran, Iran. Electronic address: fgolshahi@yahoo.com.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Fathi', 'Affiliation': 'Iran University of Medical Sciences (IUMS), Iran. Electronic address: marziehfathi@yahoo.com.'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Nazari', 'Affiliation': 'Department of Gynecology and Obstetrics, Bushehr University of Medical Sciences, Iran. Electronic address: nazarif78@yahoo.com.'}, {'ForeName': 'Behrokh', 'Initials': 'B', 'LastName': 'Sahebdel', 'Affiliation': 'Maternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences, Yas Hospital Complex, District 7, N Villa Rd, Tehran, Iran. Electronic address: Behrokh_gbwm@yahoo.com.'}]",Journal of gynecology obstetrics and human reproduction,['10.1016/j.jogoh.2021.102070'] 1836,33478494,Comparison of levonorgestrel level and creamatocrit in milk following immediate versus delayed postpartum placement of the levonorgestrel IUD.,"BACKGROUND Breastfeeding and postpartum contraception critically influence infant and maternal health outcomes. In this pilot study, we explore the effects of timing and duration of postpartum levonorgestrel exposure on milk lipid and levonorgestrel content to establish baseline data for future research. METHODS This sub-study recruited a balanced convenience sample from 259 participants enrolled in a parent randomized controlled trial comparing immediate to delayed (4-8 weeks) postpartum levonorgestrel IUD placement. All planned to breastfeed, self-selected for sub-study participation, and provided the first sample at 4-8 weeks postpartum (before IUD placement for the delayed group) and the second four weeks later. We used the Wilcoxon rank sum (inter-group) and signed rank (intra-group) tests to compare milk lipid content (creamatocrit) and levonorgestrel levels between groups and time points. RESULTS We recruited 15 participants from the immediate group and 17 from the delayed group with 10 and 12, respectively, providing both early and late samples. Initially, median levonorgestrel concentration of the immediate group (n = 10) (32.5 pg/mL, IQR: 24.8, 59.4) exceeded that of the delayed group (n = 12) (17.5 pg/mL, IQR: 0.0, 25.8) (p = 0.01). Four weeks later, the values aligned: 26.2 pg/mL (IQR: 20.3, 37.3) vs. 28.0 pg/mL (IQR: 25.2, 40.8). Creamatocrits were similar between both groups and timepoints. CONCLUSIONS Immediate postpartum levonorgestrel IUD placement results in steady, low levels of levonorgestrel in milk without apparent effects on lipid content. These findings provide initial support for the safety of immediate postpartum levonorgestrel IUD initiation, though the study was not powered to detect noninferiority between groups. TRIAL REGISTRATION This randomized controlled trial was registered with ClinicalTrials.gov (Registry No. NCT01990703) on November 21, 2013.",2021,"Creamatocrits were similar between both groups and timepoints. ","['15 participants from the immediate group and 17 from the delayed group with 10 and 12, respectively, providing both early and late samples', '259 participants enrolled']","['levonorgestrel IUD', 'immediate to delayed (4-8\xa0weeks) postpartum levonorgestrel IUD placement']","['milk lipid content (creamatocrit) and levonorgestrel levels', 'median levonorgestrel concentration']","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0015927', 'cui_str': 'Fetal death'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",259.0,0.267931,"Creamatocrits were similar between both groups and timepoints. ","[{'ForeName': 'Niaree G', 'Initials': 'NG', 'LastName': 'Hopelian', 'Affiliation': 'The University of Utah School of Medicine, 30 N 1900 E, 2B200, Salt Lake City, UT, 84132, USA.'}, {'ForeName': 'Rebecca G', 'Initials': 'RG', 'LastName': 'Simmons', 'Affiliation': 'Division of Family Planning, Department of Obstetrics and Gynecology, The University of Utah School of Medicine, 30 N 1900 E, 2B200, Salt Lake City, UT, 84132, USA.'}, {'ForeName': 'Jessica N', 'Initials': 'JN', 'LastName': 'Sanders', 'Affiliation': 'Division of Family Planning, Department of Obstetrics and Gynecology, The University of Utah School of Medicine, 30 N 1900 E, 2B200, Salt Lake City, UT, 84132, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Ward', 'Affiliation': 'The University of Utah College of Nursing, 10 S 2000 E, Salt Lake City, UT, 84112, USA.'}, {'ForeName': 'Sabrina Malone', 'Initials': 'SM', 'LastName': 'Jenkins', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, The University of Utah School of Medicine, 295 Chipeta Way, Salt Lake City, UT, 84108, USA.'}, {'ForeName': 'Eve', 'Initials': 'E', 'LastName': 'Espey', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of New Mexico School of Medicine, Albuquerque, NM, 87131, USA.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Turok', 'Affiliation': 'Division of Family Planning, Department of Obstetrics and Gynecology, The University of Utah School of Medicine, 30 N 1900 E, 2B200, Salt Lake City, UT, 84132, USA. David.Turok@hsc.utah.edu.'}]",BMC women's health,['10.1186/s12905-021-01179-7'] 1837,33392744,Involuntary sustained firing of plantar flexor motor neurones: effect of electrical stimulation parameters during tendon vibration.,"PURPOSE Simultaneous application of tendon vibration and neuromuscular electrical stimulation (NMES) induces an involuntary sustained torque. We examined the effect of different NMES parameters (intensity, pattern of stimulation and pulse width) on the magnitude of the evoked involuntary torque. METHODS Plantar flexor torque was recorded during 33-s Achilles tendon vibration with simultaneous 20-Hz NMES bouts on triceps surae (n = 20; 13 women). Intensity was set to elicit 10, 20 or 30% of maximal voluntary contraction torque (MVC), pulse width was narrow (0.2 ms) or wide (1 ms), and the stimulus pattern varied (5 × 2-s or 10 × 1-s). Up to 12 different trials were performed in a randomized order, and then repeated in those who produced a sustained involuntary torque after the cessation of vibration. RESULTS Six of 7 men and 5 of 13 women produced a post-vibration sustained torque. Eight of 20 participants did not complete the 30% trials, as they were perceived as painful. Torque during vibration at the end of NMES and the increase in torque throughout the trial were significantly higher in 20 than 10% trials (n = 11; 9.7 ± 9.0 vs 7.1 ± 6.1% MVC and 4.3 ± 4.5 vs 3.6 ± 3.5% MVC, respectively). Post-vibration sustained torque was higher in wide pulse-width trials (5.4 ± 5.9 vs 4.1 ± 4.3% MVC). Measures of involuntary torque were not different between 20 and 30% trials (n = 8). CONCLUSION Bouts of 5 × 2-s NMES with wide pulse width eliciting 20% MVC provides the most robust responses and could be used to maximise the production of involuntary torque in triceps surae.",2021,Post-vibration sustained torque was higher in wide pulse-width trials (5.4 ± 5.9 vs 4.1 ± 4.3% MVC).,['33-s Achilles tendon vibration with simultaneous 20-Hz NMES bouts on triceps surae (n\u2009=\u200920; 13 women'],"['tendon vibration and neuromuscular electrical stimulation (NMES', 'MVC']","['torque', 'post-vibration sustained torque', 'involuntary torque', 'Post-vibration sustained torque']","[{'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}]","[{'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}]",,0.025989,Post-vibration sustained torque was higher in wide pulse-width trials (5.4 ± 5.9 vs 4.1 ± 4.3% MVC).,"[{'ForeName': 'Ricardo N O', 'Initials': 'RNO', 'LastName': 'Mesquita', 'Affiliation': 'Centre for Exercise and Sports Science Research, School of Medical and Health Sciences, Edith Cowan University, Perth, Australia. r.mesquita@ecu.edu.au.'}, {'ForeName': 'Janet L', 'Initials': 'JL', 'LastName': 'Taylor', 'Affiliation': 'Centre for Exercise and Sports Science Research, School of Medical and Health Sciences, Edith Cowan University, Perth, Australia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Kirk', 'Affiliation': 'Centre for Exercise and Sports Science Research, School of Medical and Health Sciences, Edith Cowan University, Perth, Australia.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Blazevich', 'Affiliation': 'Centre for Exercise and Sports Science Research, School of Medical and Health Sciences, Edith Cowan University, Perth, Australia.'}]",European journal of applied physiology,['10.1007/s00421-020-04563-7'] 1838,33388951,Evaluation of the impact of renal impairment on the pharmacokinetics of glasdegib in otherwise healthy volunteers.,"PURPOSE Glasdegib is being developed for indications in myeloid malignancies. The effect of renal impairment on the pharmacokinetics (PK) of a single, oral, 100-mg glasdegib dose under fasted conditions was assessed. METHODS Open-label, parallel-group study (NCT03596567). Participants of good general health were selected and categorized, based on their estimated glomerular filtration rate, into normal (≥ 90 mL/min), moderate (≥ 30 to < 60 mL/min), or severe (< 30 mL/min) renal impairment groups. Blood samples were collected up to 120 h post-dose. PK exposure parameters were calculated using non-compartmental analysis. RESULTS All 18 participants completed the study. Respectively, ratios of adjusted geometric means (90% confidence interval) for glasdegib area under the curve from time 0 to infinity and peak plasma concentration versus normal participants were 205% (142-295%) and 137% (97-193%) in the moderate group, and 202% (146-281%) and 120% (77-188%) in the severe group. Glasdegib median time to peak plasma concentration was 2.0 h in both impairment groups and 1.5 h in the normal group. Mean oral clearance was decreased by approximately 50% in both renal impairment groups compared with the normal group. The plasma-free fraction of glasdegib was not altered by renal impairment. Five all-causality adverse events were reported in three participants; two were considered treatment-related. CONCLUSION The similar changes in exposure observed for participants with renal impairment, coupled with the known safety data from clinical experience, suggest that a lower starting dose of glasdegib may not be required for moderate or severe renal impairment. TRIAL REGISTRATION ClinicalTrials.gov: NCT03596567 (started May 17, 2018).",2021,Glasdegib median time to peak plasma concentration was 2.0 h in both impairment groups and 1.5 h in the normal group.,"['otherwise healthy volunteers', 'participants with renal impairment', 'All 18 participants completed the study', 'Participants of good general health were selected and categorized, based on their estimated glomerular filtration rate, into normal (≥\u200990\xa0mL/min), moderate (≥\u200930 to\u2009<\u200960\xa0mL/min), or severe (<\u200930\xa0mL/min) renal impairment groups']",[],"['ratios of adjusted geometric means', 'Mean oral clearance', 'plasma-free fraction of glasdegib', 'Glasdegib median time to peak plasma concentration', 'peak plasma concentration', 'Blood samples']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0522531', 'cui_str': 'Free fraction of'}, {'cui': 'C4519273', 'cui_str': 'glasdegib'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",,0.131592,Glasdegib median time to peak plasma concentration was 2.0 h in both impairment groups and 1.5 h in the normal group.,"[{'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Shaik', 'Affiliation': 'Clinical Pharmacology, Pfizer Inc, La Jolla, CA, USA. Naveed.Shaik@pfizer.com.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'LaBadie', 'Affiliation': 'Clinical Statistics, Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hee', 'Affiliation': 'Clinical Pharmacology, Pfizer Inc, La Jolla, CA, USA.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Chan', 'Affiliation': 'Clinical Development Oncology, Pfizer Inc, Collegeville, PA, USA.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04207-9'] 1839,33388700,Effects of aerobic walking on cognitive function in patients with schizophrenia: A randomized controlled trial.,"Cognitive deficits, which are core manifestations in schizophrenia and exhibit a limited response to antipsychotic treatment, contribute to poor treatment outcomes and functional disability. Evidence on the effect of aerobic walking (AW) and exercise intensity on cognitive function in patients with schizophrenia is lacking. In total, 79 patients with schizophrenia were recruited for a 12-week randomized control trial and allocated to the treatment-as-usual (TAU, n = 38) and treatment-as-usual plus AW (TAW, n = 39) groups. The TAW participants joined a supervised 12-week AW program consisting of 30-min sessions five times per week while wearing a Fitbit Charge 2 device. Cognitive function was evaluated using the Brief Assessment of Cognition in Schizophrenia. After randomization, 67 (34 TAU and 33 TAW) participants joined the 12-week trial and were included in the intention-to-treat analysis. Multivariate general linear model repeated measures analysis revealed no significant time × group interaction effect on cognitive function changes between the TAU and TAW groups and a marginally significant group effect on verbal fluency (p = 0.09). The interaction effect of time and treatment group on verbal fluency (p = 0.05) was marginally significant between the high and low AW intensity groups, whereas a significant group effect on attention and processing speed (p = 0.04) was observed. Supervised 12-week AW of moderate intensity may have potential cognitive benefits for patients with schizophrenia.",2021,Multivariate general linear model repeated measures analysis revealed no significant time × group interaction effect on cognitive function changes between the TAU and TAW groups and a marginally significant group effect on verbal fluency (p = 0.09).,"['patients with schizophrenia', 'patients with schizophrenia is lacking', '79 patients with schizophrenia']","['aerobic walking (AW) and exercise intensity', 'aerobic walking']","['verbal fluency', 'Cognitive function', 'attention and processing speed', 'cognitive function', 'cognitive function changes', 'Cognitive deficits']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}]",79.0,0.0250775,Multivariate general linear model repeated measures analysis revealed no significant time × group interaction effect on cognitive function changes between the TAU and TAW groups and a marginally significant group effect on verbal fluency (p = 0.09).,"[{'ForeName': 'Yu-Chi', 'Initials': 'YC', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan. Electronic address: ychuang01@gmail.com.'}, {'ForeName': 'Chi-Fa', 'Initials': 'CF', 'LastName': 'Hung', 'Affiliation': 'Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'Su-Ting', 'Initials': 'ST', 'LastName': 'Hsu', 'Affiliation': 'Kaohsiung Municipal Kai-Syuan Psychiatric Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Pao-Yen', 'Initials': 'PY', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan; Institute for Translational Research in Biomedical Sciences, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'Mian-Yoon', 'Initials': 'MY', 'LastName': 'Chong', 'Affiliation': 'Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'Chien-Chih', 'Initials': 'CC', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'Yu-Hsin', 'Initials': 'YH', 'LastName': 'Kuo', 'Affiliation': 'Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'Liang-Jen', 'Initials': 'LJ', 'LastName': 'Wang', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan. Electronic address: wangliangjen@gmail.com.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.12.062'] 1840,33394894,Effects of Four Different Velocity-Based Training Programming Models on Strength Gains and Physical Performance.,"ABSTRACT Riscart-López, J, Rendeiro-Pinho, G, Mil-Homens, P, Costa, RS-d, Loturco, I, Pareja-Blanco, F, and León-Prados, JA. Effects of Four different velocity-based training programming models on strength gains and physical performance. J Strength Cond Res 35(3): 596-603, 2021-The aim of this study was to compare the effects of 4 velocity-based training (VBT) programming models (linear programming [LP], undulating programming [UP], reverse programming [RP], and constant programming [CP]) on the physical performance of moderately strength-trained men. Forty-three young (age: 22.9 ± 4.8 years; body mass [BM]: 71.7 ± 7.6; full squat [SQ] relative strength 1.32 ± 0.29) subjects were randomly assigned to LP (gradually increase training intensity and decrease volume), UP (volume and intensity increase or decrease repeatedly), RP (gradually increases volume and decrease intensity), and CP (maintains constant volume and intensity) groups and followed an 8-week VBT intervention using the SQ exercise and monitoring movement velocity for every repetition. All groups trained with similar relative average intensity (67.5% 1 repetition maximum [1RM]), magnitude of velocity loss within the set (20%), number of sets (3), and interset recoveries (4 minutes) throughout the training program. Pre-training and post-training measurements included predicted SQ (1RM), average velocity attained for all loads common to pre-tests and post-tests (AV), average velocity for those loads that were moved faster (AV > 1) and slower (AV < 1) than 1 m·s-1 at pre-tests, countermovement jump height (CMJ), and 20-m sprint time (T20). No significant group × time interactions were observed for any of the variables analyzed. All groups obtained similar increases (shown in effect size values) in 1RM strength (LP: 0.88; UP: 0.54; RP: 0.62; CP: 0.51), velocity-load-related variables (LP: 0.74-4.15; UP: 0.46-5.04; RP: 0.36-3.71; CP: 0.74-3.23), CMJ height (LP: 0.35; UP: 0.53; RP: 0.49; CP: 0.34), and sprint performance (LP: 0.34; UP: 0.35; RP: 0.32; CP: 0.30). These results suggest that different VBT programming models induced similar physical performance gains in moderately strength-trained subjects.",2021,"All groups obtained similar increases (shown in effect size values) in 1RM strength (LP: 0.88; UP: 0.54; RP: 0.62; CP: 0.51), velocity-load-related variables (LP: 0.74-4.15; UP: 0.46-5.04; RP: 0.36-3.71; CP: 0.74-3.23), CMJ height (LP: 0.35;","['moderately strength-trained men', 'Forty-three young (age: 22.9 ± 4.8 years; body mass [BM', 'moderately strength-trained subjects']","['Four different velocity-based training programming models', 'VBT intervention using the SQ exercise and monitoring movement velocity for every repetition', 'J Strength Cond Res XX(X', 'Four Different Velocity-Based Training Programming Models', '4 velocity-based training (VBT) programming models (linear programming [LP], undulating programming [UP], reverse programming [RP], and constant programming [CP']","['training intensity and decrease volume), UP (volume and intensity increase or decrease repeatedly), RP (gradually increases volume and decrease intensity), and CP (maintains constant volume and intensity', 'number of sets (3), and interset recoveries', 'magnitude of velocity loss', 'Strength Gains and Physical Performance', 'strength gains and physical performance', 'time interactions', '1RM strength', 'SQ (1RM), average velocity attained for all loads common to pre-tests and post-tests (AV), average velocity for those loads', 'physical performance gains', 'countermovement jump height (CMJ), and 20-m sprint time (T20', 'CMJ height']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517765', 'cui_str': '4.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]","[{'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0033349', 'cui_str': 'Programming, Linear'}, {'cui': 'C1720529', 'cui_str': 'Constant'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}]",,0.0183238,"All groups obtained similar increases (shown in effect size values) in 1RM strength (LP: 0.88; UP: 0.54; RP: 0.62; CP: 0.51), velocity-load-related variables (LP: 0.74-4.15; UP: 0.46-5.04; RP: 0.36-3.71; CP: 0.74-3.23), CMJ height (LP: 0.35;","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Riscart-López', 'Affiliation': 'Faculty of Sport Sciences, Pablo de Olavid University, Seville, Spain.'}, {'ForeName': 'Gonçalo', 'Initials': 'G', 'LastName': 'Rendeiro-Pinho', 'Affiliation': 'Faculty of Human Kinetics, University of Lisbon, Lisbon, Portugal.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Mil-Homens', 'Affiliation': 'Faculty of Human Kinetics, University of Lisbon, Lisbon, Portugal.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Soares-daCosta', 'Affiliation': 'Jamor High Performance Sports Center, Lisboa, Portugal.'}, {'ForeName': 'Irineu', 'Initials': 'I', 'LastName': 'Loturco', 'Affiliation': 'Nucleus of High Performance in Sport, São Paulo, Brazil.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Pareja-Blanco', 'Affiliation': 'Faculty of Sport Sciences, Pablo de Olavid University, Seville, Spain.'}, {'ForeName': 'Juan A', 'Initials': 'JA', 'LastName': 'León-Prados', 'Affiliation': 'Faculty of Sport Sciences, Pablo de Olavid University, Seville, Spain.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003934'] 1841,33399382,Protective effect of sevoflurane on vascular endothelial glycocalyx in patients undergoing heart valve surgery: A randomised controlled trial.,"BACKGROUND The glycocalyx plays an important physiological role and may be damaged during cardiopulmonary bypass. Sevoflurane can protect the glycocalyx; however, its relevance in a clinical setting is unknown. OBJECTIVE Glycocalyx degradation during cardiopulmonary bypass in patients was investigated. On the basis of the available experimental data, we hypothesised that sevoflurane-based anaesthesia would confer additional protection against cardiopulmonary bypass-induced glycocalyx damage. DESIGN Randomised controlled study. SETTING Clinical study at The First Affiliated Hospital of Wenzhou Medical University between June 2018 and March 2019. PATIENTS Fifty-one patients. INTERVENTIONS After intubation and mechanical ventilation, patients undergoing elective heart valve surgery were maintained under general anaesthesia with either propofol or sevoflurane during surgery. MAIN OUTCOME MEASURES Glycocalyx markers (such as syndecan-1, heparan sulphate and hyaluronan), sheddases responsible for the degradation of the endothelial glycocalyx (such as matrix metalloproteinase-9 and cathepsin-B), urine albumin-to-creatinine ratio and levels of lactic acid and myocardial enzymes were all measured. Postoperative mechanical ventilation time and length of stay in the cardiac care unit and hospital were also measured. Morbidity and mortality after 30 days and 1 year were evaluated. RESULTS The vascular endothelial glycocalyx was damaged during cardiopulmonary bypass. The glycocalyx damage in the sevoflurane group was less extensive than that in the propofol group. The urine albumin-to-creatinine ratio increased in both groups but was lower in the sevoflurane group. Enzymes including matrix metalloproteinase-9 and cathepsin-B were positively correlated with glycocalyx marker concentrations. After operation, the sevoflurane group showed lower levels of lactic acid and myocardial enzyme, as well as shorter duration of postoperative mechanical ventilation than the propofol group. CONCLUSION Sevoflurane can decrease glycocalyx degradation in patients undergoing heart valve surgery under cardiopulmonary bypass. TRIAL REGISTRATION Chinese Clinical Trial Registry, chictr.org.cn, identifier: ChiCTR1800016367.",2021,"After operation, the sevoflurane group showed lower levels of lactic acid and myocardial enzyme, as well as shorter duration of postoperative mechanical ventilation than the propofol group. ","['patients undergoing heart valve surgery under cardiopulmonary bypass', 'Clinical study at The First Affiliated Hospital of Wenzhou Medical University between June 2018 and March 2019', 'Fifty-one patients', 'patients undergoing elective heart valve surgery']","['Sevoflurane', 'propofol', 'sevoflurane', 'propofol or sevoflurane', 'sevoflurane-based anaesthesia', 'mechanical ventilation']","['Morbidity and mortality', 'Glycocalyx markers (such as syndecan-1, heparan sulphate and hyaluronan), sheddases responsible for the degradation of the endothelial glycocalyx (such as matrix metalloproteinase-9 and cathepsin-B), urine albumin-to-creatinine ratio and levels of lactic acid and myocardial enzymes', 'matrix metalloproteinase-9 and cathepsin-B', 'glycocalyx damage', 'Postoperative mechanical ventilation time and length of stay in the cardiac care unit and hospital', 'levels of lactic acid and myocardial enzyme', 'urine albumin-to-creatinine ratio', 'glycocalyx degradation', 'shorter duration of postoperative mechanical ventilation', 'vascular endothelial glycocalyx']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018825', 'cui_str': 'Cardiac valve prosthesis'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0061622', 'cui_str': 'Glycocalyx'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0753253', 'cui_str': 'SDC1 protein, human'}, {'cui': 'C0019143', 'cui_str': 'Heparan sulfate'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C1273518', 'cui_str': 'Responsible to'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C0699919', 'cui_str': 'Cathepsin B'}, {'cui': 'C0042038', 'cui_str': 'Albumin urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0064582', 'cui_str': 'lactic acid'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0150158', 'cui_str': 'Cardiac care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}]",,0.0998492,"After operation, the sevoflurane group showed lower levels of lactic acid and myocardial enzyme, as well as shorter duration of postoperative mechanical ventilation than the propofol group. ","[{'ForeName': 'Fu-Quan', 'Initials': 'FQ', 'LastName': 'Fang', 'Affiliation': 'From the The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou (FQ-F) and The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China (JH-S, QL-W, LY-F, YX-F, JX-Y, W-G, GL-H, WJ-W).'}, {'ForeName': 'Jie-Hao', 'Initials': 'JH', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'Qiao-Lin', 'Initials': 'QL', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Lin-Ya', 'Initials': 'LY', 'LastName': 'Feng', 'Affiliation': ''}, {'ForeName': 'Yu-Xiu', 'Initials': 'YX', 'LastName': 'Fan', 'Affiliation': ''}, {'ForeName': 'Jun-Xin', 'Initials': 'JX', 'LastName': 'Ye', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': ''}, {'ForeName': 'Guo-Liang', 'Initials': 'GL', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Wei-Jian', 'Initials': 'WJ', 'LastName': 'Wang', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001429'] 1842,33398481,Lower body mass index and age are predictive of improved pain and health utility scores following arthroscopic management of femoroacetabular impingement.,"PURPOSE To identify patient factors associated with improved pain scores, functional hip scores, health-related quality of life, and re-operation rates after arthroscopic management of femoroacetabular impingement (FAI). METHODS Using the comprehensive dataset from the multinational Femoroacetabular Impingement Randomized Controlled Trial (FIRST), a total of 13 prognostic factors that were chosen a priori were identified that would be expected to predict post-surgical outcomes. The primary outcome was pain assessed using a Visual Analogue Scale (VAS) and secondary outcomes included hip function (Hip Outcome Score [HOS] and International Hip Outcome Tool [iHOT-12]), health-related quality of life (Short Form-12 [SF-12] and Euro-Qol 5 Dimensions [EQ-5D]), and re-operation rate. A multivariable linear regression was used to analyse the change questionnaire scores from baseline to 12 months post-surgery including all 13 prognostic factors as independent variables. A total of 27 re-operation events were analysed at 24 months using a multivariable logistic regression including only the treatment group variable. RESULTS Of the 154 patients that had VAS scores completed at 12 months, a lower BMI (adjusted mean difference [aMD], 4.48 for a 5-unit decrease in BMI; 95% confidence interval [CI] 0.33-8.63; p = 0.035) was significantly associated with less pain. There was a significant negative association between increasing age and 1-year EQ-5D scores (aMD, - 0.04 for every 10-year increase in age; 95% CI - 0.07 to - 0.006; p = 0.020). The degree of impingement, severity of osteoarthritis, type of procedure, and adjudicated quality of surgery were not significantly associated with improvement across all outcomes at 12 months. Furthermore, there was no significant association between the treatment variable and the incidence of re-operation at 24 months. CONCLUSION This study identified that lower BMI and age are predictive of improved pain and health utility scores, respectively, following arthroscopic management of FAI at 12 months post-surgery. These results may be a helpful adjunct in clinical decisions for this patient population when determining candidacy for surgical intervention. LEVEL OF EVIDENCE I.",2021,"There was a significant negative association between increasing age and 1-year EQ-5D scores (aMD, - 0.04 for every 10-year increase in age; 95% CI - 0.07 to - 0.006; p = 0.020).",[],[],"['1-year EQ-5D scores', 'pain and health utility scores', 'lower BMI', 'pain assessed using a Visual Analogue Scale (VAS) and secondary outcomes included hip function (Hip Outcome Score [HOS] and International Hip Outcome Tool [iHOT-12]), health-related quality of life (Short Form-12 [SF-12] and Euro-Qol 5 Dimensions [EQ-5D]), and re-operation rate', 'pain scores, functional hip scores, health-related quality of life, and re-operation rates after arthroscopic management of femoroacetabular impingement (FAI', 'VAS scores', 'change questionnaire scores', 'pain', 'degree of impingement, severity of osteoarthritis, type of procedure, and adjudicated quality of surgery']",[],[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C1533125', 'cui_str': 'Euro'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C2936290', 'cui_str': 'Femoral acetabular impingement'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0455713', 'cui_str': 'Procedure type'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",154.0,0.101756,"There was a significant negative association between increasing age and 1-year EQ-5D scores (aMD, - 0.04 for every 10-year increase in age; 95% CI - 0.07 to - 0.006; p = 0.020).","[{'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Kay', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University Medical Centre, 1200 Main St West, 4E15, Hamilton, ON, L8N 3Z5, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Simunovic', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University Medical Centre, 1200 Main St West, 4E15, Hamilton, ON, L8N 3Z5, Canada.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Heels-Ansdell', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Bhandari', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University Medical Centre, 1200 Main St West, 4E15, Hamilton, ON, L8N 3Z5, Canada.'}, {'ForeName': 'Olufemi R', 'Initials': 'OR', 'LastName': 'Ayeni', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University Medical Centre, 1200 Main St West, 4E15, Hamilton, ON, L8N 3Z5, Canada. ayenif@mcmaster.ca.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-020-06395-6'] 1843,33404004,"Substance use and depressive and anxiety symptoms among out-of-school adolescent girls and young women in Cape Town, South Africa.","BACKGROUND There is a high prevalence of substance use among youth in South Africa (SA), and adolescent girls and young women (AGYW) experience high rates of depression and anxiety. Substance use behaviours and mental health are associated with other public health problems among AGYW such as HIV and unintended pregnancy. Therefore, understanding the relationship between substance use and mental health is imperative to improve AGYW's health. OBJECTIVES To examine the association between heavy drinking, marijuana, methamphetamine and methaqualone (Mandrax) use and depressive and anxiety symptoms among AGYW aged 16 - 19 years who have dropped out of school in Cape Town, SA. METHODS Data for this report come from the baseline data of 500 participants of an ongoing cluster-randomised trial assessing the efficacy of a young woman-focused intervention to reduce substance use and HIV risk. After AGYW consented/assented to participate, they completed a urine drug screen and a baseline questionnaire. RESULTS Logistic and negative binomial regressions, controlling for clustering at the neighbourhood level, revealed that frequency of depressive symptoms was significantly and positively related to a positive drug screen for Mandrax (β=0.07; p=0.03). All other associations between the frequency of depressive symptoms and substance use were not statistically significant (ps>0.05). The associations between frequency of anxiety symptoms and substance use were not statistically significant (ps>0.05). CONCLUSIONS Our findings highlight the need to address substance use, especially Mandrax use and its associated risk, and depression in an integrated, youth-friendly setting.",2020,"The associations between frequency of anxiety symptoms and substance use were not statistically significant (ps>0.05). ","['aged 16 - 19 years who have dropped out of school in Cape Town, SA', 'out-of-school adolescent girls and young women in Cape Town, South Africa']","['young woman-focused intervention', 'methamphetamine and methaqualone (Mandrax']","['frequency of anxiety symptoms and substance use', 'Substance use and depressive and anxiety symptoms', 'frequency of depressive symptoms', 'frequency of depressive symptoms and substance use']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0025627', 'cui_str': 'Methaqualone'}, {'cui': 'C0065638', 'cui_str': 'Mandrax'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",500.0,0.0582651,"The associations between frequency of anxiety symptoms and substance use were not statistically significant (ps>0.05). ","[{'ForeName': 'C P', 'Initials': 'CP', 'LastName': 'Bonner', 'Affiliation': 'Substance Use, Gender, and Applied Research Program, RTI International, Atlanta, GA, USA. cpbonner@rti.org.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Carney', 'Affiliation': ''}, {'ForeName': 'F A', 'Initials': 'FA', 'LastName': 'Browne', 'Affiliation': ''}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Ndirangu', 'Affiliation': ''}, {'ForeName': 'B N', 'Initials': 'BN', 'LastName': 'Howard', 'Affiliation': ''}, {'ForeName': 'W M', 'Initials': 'WM', 'LastName': 'Wechsberg', 'Affiliation': ''}]",South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde,['10.7196/SAMJ.2020.v111i1.14520'] 1844,33403443,[Preoperative radiotherapy plus resection versus surgery alone in patients with primary retroperitoneal sarcoma (EORTC-62092: STRASS): a multicenter randomized phase III study].,,2021,,['patients with primary retroperitoneal sarcoma (EORTC-62092'],['radiotherapy plus resection versus surgery alone'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0585129', 'cui_str': 'Retroperitoneal sarcoma'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",[],,0.0333027,,"[{'ForeName': 'Gerhard G', 'Initials': 'GG', 'LastName': 'Grabenbauer', 'Affiliation': 'Strahlentherapie & Radioonkologie am Klinikum Coburg, Ketschendorfer Straße\xa033, 96450, Coburg, Deutschland. gg@diestrahlentherapeuten.de.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-020-01734-5'] 1845,33289818,Neurodevelopmental Outcomes at Age 5 Years After Prophylactic Early High-Dose Recombinant Human Erythropoietin for Neuroprotection in Very Preterm Infants.,,2020,,['Very Preterm Infants'],['Recombinant Human Erythropoietin'],[],"[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}]",[],,0.0409619,,"[{'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Natalucci', 'Affiliation': 'Department of Neonatology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Bea', 'Initials': 'B', 'LastName': 'Latal', 'Affiliation': ""Child Development Center, University Children's Hospital Zurich, Zurich, Switzerland.""}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Koller', 'Affiliation': 'Department of Neonatology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Rüegger', 'Affiliation': 'Department of Neonatology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Sick', 'Affiliation': 'Epidemiology, Biostatistics, and Prevention Institute (EBPI), University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Leonhard', 'Initials': 'L', 'LastName': 'Held', 'Affiliation': 'Epidemiology, Biostatistics, and Prevention Institute (EBPI), University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Fauchère', 'Affiliation': 'Department of Neonatology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.19395'] 1846,33411115,Renal prognoses by different target hemoglobin levels achieved by epoetin beta pegol dosing to chronic kidney disease patients with hyporesponsive anemia to erythropoiesis-stimulating agent: a multicenter open-label randomized controlled study.,"BACKGROUND There is no evidence regarding appropriate target hemoglobin levels in chronic kidney disease (CKD) patients with an erythropoiesis-stimulating agent (ESA)-hyporesponsiveness. Therefore, we conducted a randomized controlled study in non-dialysis dependent CKD (NDD-CKD) patients with ESA-hyporesponsiveness, comparing results of intensive versus conservative treatment to maintain hemoglobin levels. METHODS This was a multicenter, open-label, randomized, parallel-group study conducted at 89 institutions. Among NDD-CKD patients, those with ESA-hyporesponsive renal anemia were randomly assigned to an intensive treatment group, to which epoetin beta pegol was administered with target hemoglobin level of 11 g/dL or higher, or conservative treatment group, in which the hemoglobin levels at enrollment (within ± 1 g/dL) were maintained. The primary endpoint was the time to the first kidney composite event defined as (1) transition to renal replacement therapy (dialysis or renal transplantation); (2) reduction of estimated glomerular filtration rate (eGFR) to less than 6.0 mL/min/1.73 m 2 ; or (3) reduction of eGFR by 30% or more. Secondary endpoints were kidney function (change rate in eGFR), cardiovascular (CV) events, and safety. RESULTS Between August 2012 and December 2015, 385 patients were registered, and 362 patients who met the eligibility criteria were enrolled. There was no significant difference in kidney survival or in CV events between the two groups. However, the incidences of the 3 types of kidney composite events tended to differ. CONCLUSIONS In NDD-CKD patients with ESA-hyporesponsive renal anemia, the aggressive administration of ESA did not clearly extend kidney survival or result in a significant difference in the incidence of CV events.",2021,There was no significant difference in kidney survival or in CV events between the two groups.,"['89 institutions', '362 patients who met the eligibility criteria were enrolled', 'Between August 2012 and December 2015, 385 patients were registered, and', 'non-dialysis dependent CKD (NDD-CKD) patients with ESA-hyporesponsiveness', 'NDD-CKD patients, those with ESA-hyporesponsive renal anemia', 'chronic kidney disease (CKD) patients with an erythropoiesis-stimulating agent (ESA)-hyporesponsiveness']","['ESA', 'epoetin beta pegol was administered with target hemoglobin level of 11\xa0g/dL or higher, or conservative treatment', 'erythropoiesis-stimulating agent', 'epoetin beta pegol']","['kidney survival', 'kidney function (change rate in eGFR), cardiovascular (CV) events, and safety', 'eGFR', 'incidence of CV events', 'kidney survival or in CV events', 'time to the first kidney composite event defined as (1) transition to renal replacement therapy (dialysis or renal transplantation); (2) reduction of estimated glomerular filtration rate (eGFR', 'kidney composite events']","[{'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4517751', 'cui_str': '385'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C1142276', 'cui_str': 'Renal anemia'}]","[{'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C1328071', 'cui_str': 'Methoxy polyethylene glycol-epoetin beta'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",385.0,0.0272579,There was no significant difference in kidney survival or in CV events between the two groups.,"[{'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Tsuruya', 'Affiliation': 'Department of Nephrology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8521, Japan. tsuruya@naramed-u.ac.jp.'}, {'ForeName': 'Terumasa', 'Initials': 'T', 'LastName': 'Hayashi', 'Affiliation': 'Department of Kidney Disease and Hypertension, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Hiroyasu', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Hase', 'Affiliation': 'Aoba Hospital, Tokyo, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Nishi', 'Affiliation': 'Division of Nephrology and Kidney Center, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Kunihiro', 'Initials': 'K', 'LastName': 'Yamagata', 'Affiliation': 'Division of Clinical Medicine, Department of Nephrology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Masaomi', 'Initials': 'M', 'LastName': 'Nangaku', 'Affiliation': 'Division of Nephrology and Endocrinology, The University of Tokyo Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Wada', 'Affiliation': 'Department of Nephrology and Laboratory Medicine, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Yukari', 'Initials': 'Y', 'LastName': 'Uemura', 'Affiliation': 'Biostatistics Section, Department of Data Science, Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Ohashi', 'Affiliation': 'Department of Integrated Science and Engineering for Sustainable Society, Chuo University, Tokyo, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Hirakata', 'Affiliation': 'Fukuoka Renal Clinic, Fukuoka, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical and experimental nephrology,['10.1007/s10157-020-02005-4'] 1847,33408307,Surgical Outcome and Histological Differences between Individuals with TGFBR1 and TGFBR2 Mutations in Loeys-Dietz Syndrome.,"PURPOSE To identify differences in surgical outcomes between patients with transforming growth factor-beta receptor (TGFBR) 1 and TGFBR2 mutations in Loeys-Dietz syndrome (LDS). METHODS In all, 22 LDS patients between 1998 and 2015 were divided into the two groups: TGFBR1 (n = 11) and TGFBR2 mutation (n = 11). RESULTS The freedom from aortic reoperation was similar between the two groups (p = 0.19, log-rank). In the subanalysis, the freedom from aortic reoperation was lower in female patients with TGFBR2 mutations (n = 6) than in other patients (p = 0.08). The freedom from aortic dissection (AD) after the initial surgery was also lower in female patients with TGFBR2 mutation than in other patients (p = 0.025). All patients with TGFBR2 mutations revealed grade III cystic medial necrosis (CMN), whereas 67% of patients with TGFBR1 mutations showed CMN (p = 0.033) and only one patient had grade III (p <0.001). CONCLUSION LDS patients with TGFBR2 mutations had higher grade of CMN than those of TGFBR1 mutations. In particular, in female patients with TGFBR2 mutations, AD after the initial surgery and reoperation were more frequent than those of other LDS patients.",2021,"The freedom from aortic reoperation was similar between the two groups (p = 0.19, log-rank).","['patients with transforming growth factor-beta receptor (TGFBR) 1 and TGFBR2 mutations in Loeys-Dietz syndrome (LDS', 'LDS patients with TGFBR2 mutations', 'female patients with TGFBR2 mutations', '22 LDS patients between 1998 and 2015 were divided into the two groups: TGFBR1 (n = 11) and TGFBR2 mutation (n = 11']",[],"['freedom from aortic reoperation', 'grade of CMN', 'grade III cystic medial necrosis (CMN']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0076930', 'cui_str': 'Transforming Growth Factor beta Receptors'}, {'cui': 'C0214897', 'cui_str': 'Transforming Growth Factor-beta Type II Receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0292688', 'cui_str': 'TGF-beta Receptor Protein Kinase'}]",[],"[{'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0392775', 'cui_str': 'Medionecrosis of aorta'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}]",22.0,0.0157315,"The freedom from aortic reoperation was similar between the two groups (p = 0.19, log-rank).","[{'ForeName': 'Yoshimasa', 'Initials': 'Y', 'LastName': 'Seike', 'Affiliation': 'Department of Cardiovascular Surgery, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Matsuda', 'Affiliation': 'Department of Cardiovascular Surgery, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Hatsue', 'Initials': 'H', 'LastName': 'Ishibashi-Ueda', 'Affiliation': 'Department of Pathology, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Morisaki', 'Affiliation': 'Department of Medical Genetics, Sakakibara Heart Institute, Fuchu, Tokyo, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Morisaki', 'Affiliation': 'Department of Molecular Pathology, Institute of Medical Science, the University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Minatoya', 'Affiliation': 'Department of Cardiovascular Surgery, Kyoto University Graduate School of Medicine, Kyoto, Kyoto, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Ogino', 'Affiliation': 'Department of Cardiovascular Surgery, Tokyo Medical University, Tokyo, Japan.'}]",Annals of thoracic and cardiovascular surgery : official journal of the Association of Thoracic and Cardiovascular Surgeons of Asia,['10.5761/atcs.oa.20-00223'] 1848,33414066,Editor's Choice - A Cost Effectiveness Analysis of Outpatient versus Inpatient Hospitalisation for Lower Extremity Arterial Disease Endovascular Revascularisation in France: A Randomised Controlled Trial.,"OBJECTIVE The AMBUVASC trial evaluated the cost effectiveness of outpatient vs. inpatient hospitalisation for endovascular repair of lower extremity arterial disease (LEAD). METHODS AMBUVASC was a national multicentre, prospective, randomised controlled trial conducted in nine public and two private French centres. The primary endpoint was the incremental cost effectiveness ratio (ICER), defined by cost per quality adjusted life year (QALY). Analysis was conducted from a societal perspective, excluding indirect costs, and considering a one month time horizon. RESULTS From 16 February 2016 to 29 May 2017, 160 patients were randomised (80 per group). A modified intention to treat analysis was performed with 153 patients (outpatient hospitalisation: n = 76; inpatient hospitalisation: n = 77). The patients mainly presented intermittent claudication (outpatient arm: 97%; inpatient arm: 92%). Rates of peri-operative complications were 20% (15 events) and 18% (14 events) for the outpatient and inpatient arms respectively (p = .81). Overall costs (difference: €187.83; 95% confidence interval [CI] -275.68-651.34) and QALYs (difference: 0.00277; 95% CI -0.00237 - 0.00791) were higher for outpatients due to more re-admissions than the inpatient arm. The mean ICER was €67 741 per QALY gained for the base case analysis with missing data imputed using multiple imputation by predictive mean matching. The outpatient procedure was not cost effective for a willingness to pay of €50 000 per QALY and the probability of being cost effective was only 59% for a €100 000/QALY threshold. CONCLUSION Outpatient hospitalisation is not cost effective compared with inpatient hospitalisation for endovascular repair of patients with claudication at a €50 000/QALY threshold.",2021,Overall costs (difference: €187.83; 95% confidence interval [CI] -275.68-651.34) and QALYs (difference: 0.00277; 95% CI -0.00237 - 0.00791) were higher for outpatients due to more re-admissions than the inpatient arm.,"['patients mainly presented intermittent claudication (outpatient arm: 97%; inpatient arm: 92', '153 patients (outpatient hospitalisation: n\xa0=\xa076; inpatient hospitalisation: n\xa0=\xa077', 'From 16 February 2016 to 29 May 2017, 160 patients', 'nine public and two private French centres', 'Lower Extremity Arterial Disease Endovascular Revascularisation in France']",['Outpatient versus Inpatient Hospitalisation'],"['mean ICER', 'Rates of peri-operative complications', 'Overall costs', 'probability of being cost effective', 'incremental cost effectiveness ratio (ICER), defined by cost per quality adjusted life year (QALY']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0021775', 'cui_str': 'Intermittent claudication'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0852949', 'cui_str': 'Disorder of artery'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",160.0,0.315803,Overall costs (difference: €187.83; 95% confidence interval [CI] -275.68-651.34) and QALYs (difference: 0.00277; 95% CI -0.00237 - 0.00791) were higher for outpatients due to more re-admissions than the inpatient arm.,"[{'ForeName': 'Yann', 'Initials': 'Y', 'LastName': 'Gouëffic', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Groupe Hôpitalier Paris St Joseph, Paris, France. Electronic address: ygoueffic@ghpsj.fr.'}, {'ForeName': 'Jean L', 'Initials': 'JL', 'LastName': 'Pin', 'Affiliation': 'Service de Chirurgie Vasculaire, Hôpital Privé Dijon Bourgogne, Dijon, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Sabatier', 'Affiliation': ""Clinique de l'Europe, Rouen, France.""}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Alimi', 'Affiliation': 'Service de Chirurgie Vasculaire, Hôpital Nord, Marseille, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Steinmetz', 'Affiliation': 'Service de Chirurgie Cardio-Thoracique, Centre Hospitalier Universitaire de Dijon, Dijon, France.'}, {'ForeName': 'Pierre-Edouard', 'Initials': 'PE', 'LastName': 'Magnan', 'Affiliation': 'Service de Chirurgie Vasculaire, Hôpital La Timone, Marseille, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Marret', 'Affiliation': 'Service de Chirurgie Vasculaire, Centre Hospitalier Départemental Vendée-La Roche sur Yon, La Roche sur Yon, France.'}, {'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Kaladji', 'Affiliation': 'Service de Chirurgie Vasculaire, Centre Hospitalier Universitaire de Rennes, Rennes, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Chavent', 'Affiliation': 'Service de Chirurgie Vasculaire, Centre Hospitalier Universitaire de St-Etienne-Hôpital Nord, Saint Etienne, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Kretz', 'Affiliation': 'Service de Chirurgie Vasculaire, Hôpitaux Civils de Colmar, Colmar, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Jobert', 'Affiliation': 'Département Promotion, Centre Hospitalier Universitaire de Nantes, Nantes Université, Nantes, France.'}, {'ForeName': 'Solène', 'Initials': 'S', 'LastName': 'Schirr-Bonnans', 'Affiliation': 'Service Evaluation Economique et Développement des Produits de Santé, Département Partenariats et Innovation, Centre Hospitalier Universitaire de Nantes, Nantes Université, Nantes, France.'}, {'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': ""Guyomarc'h"", 'Affiliation': 'Institut du Thorax, Centre Hospitalier Universitaire de Nantes, Nantes Université, Nantes, France.'}, {'ForeName': 'Valéry P', 'Initials': 'VP', 'LastName': 'Riche', 'Affiliation': 'Service Evaluation Economique et Développement des Produits de Santé, Département Partenariats et Innovation, Centre Hospitalier Universitaire de Nantes, Nantes Université, Nantes, France.'}, {'ForeName': 'Lucie S', 'Initials': 'LS', 'LastName': 'du Mont', 'Affiliation': 'Service de Chirurgie Vasculaire, Centre Hospitalier Régional Universitaire de Besançon-Hôpital Jean Minjoz, Besançon, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Tessier', 'Affiliation': 'Service Evaluation Economique et Développement des Produits de Santé, Département Partenariats et Innovation, Centre Hospitalier Universitaire de Nantes, Nantes Université, Nantes, France; SPHERE (UMR INSERM 1246), Université de Nantes & Université de Tours, France.'}]",European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery,['10.1016/j.ejvs.2020.11.030'] 1849,33411640,"Timing of acute passive heating on glucose tolerance and blood pressure in people with type 2 diabetes: a randomized, balanced crossover, control trial.","Type 2 diabetes mellitus (T2DM) is characterized by chronic hyperglycemia and progressive insulin resistance, leading to macro and microvascular dysfunction. Passive heating has potential to improve glucose homeostasis and act as an exercise mimetic. We assessed the effect of acute passive heating before or during an oral glucose tolerance test (OGTT) in people with T2DM. Twelve people with T2DM were randomly assigned to the following three conditions: 1 ) 3-h OGTT (control), 2 ) 1-h passive heating (40°C water) 30 min before an OGTT (HOT-OGTT), and 3 ) 1-h passive heating (40°C water) 30 min after commencing an OGTT (OGTT-HOT). Blood glucose concentration, insulin sensitivity, extracellular heat shock protein 70 (eHSP70), total energy expenditure (TEE), heart rate (HR), systolic blood pressure (SBP), and diastolic blood pressure (DBP) were recorded. Passive heating did not alter blood glucose concentration [control: 1,677 (386) arbitrary units (AU), HOT-OGTT: 1,797 (340) AU, and OGTT-HOT: 1,662 (364) AU, P = 0.28], insulin sensitivity ( P = 0.15), or SBP ( P = 0.18) but did increase eHSP70 concentration in both heating conditions [control: 203.48 (110.81) pg·mL -1 ; HOT-OGTT: 402.47 (79.02) pg·mL -1 ; and OGTT-HOT: 310.00 (60.53) pg·mL -1 , P < 0.001], increased TEE (via fat oxidation) in the OGTT-HOT condition [control: 263 (33) kcal, HOT-OGTT: 278 (40) kcal, and OGTT-HOT: 304 (38) kcal, P = 0.001], increased HR in both heating conditions ( P < 0.001), and reduced DBP in the OGTT-HOT condition ( P < 0.01). Passive heating in close proximity to a glucose challenge does not alter glucose tolerance but does increase eHSP70 concentration and TEE and reduce blood pressure in people with T2DM. NEW & NOTEWORTHY This is the first study to investigate the timing of acute passive heating on glucose tolerance and extracellular heat shock protein 70 concentration ([eHSP70]) in people with type 2 diabetes. The principal novel findings from this study were that both passive heating conditions: 1 ) did not reduce the area under the curve or peak blood glucose concentration, 2 ) elevated heart rate, and 3 ) increased [eHSP70], which was blunted by glucose ingestion, while passive heating following glucose ingestion, 4 ) increased total energy expenditure, and 5 ) reduced diastolic blood pressure.",2021,"Passive heating did not alter blood [glucose] (CON, 1,677 (386) a.u.; HOT-OGTT, 1,797 (340) a.u.; OGTT-HOT, 1,662 (364) a.u.; P = 0.28), insulin sensitivity (P = 0.15), or SBP (P = 0.18), but did increase [eHSP70] in both heating conditions (CON, 203.48 (110.81)","['Type 2 diabetes mellitus (T2DM', 'Twelve people with T2DM were randomly assigned to 3 conditions:1', 'people with T2DM']",[],"['increase [eHSP70', 'Blood [glucose], insulin sensitivity, extracellular heat shock protein 70 (eHSP70), total energy expenditure (TEE), heart rate (HR), systolic (SBP) and diastolic blood pressure (DBP', 'increased TEE (via fat oxidation', 'blood [glucose', 'glucose tolerance', 'SBP', 'blood pressure', 'reduced DBP in OGTT-HOT condition', 'insulin sensitivity']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]",[],"[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0521119', 'cui_str': 'Extracellular'}, {'cui': 'C0243043', 'cui_str': 'Heat-Shock Proteins 70'}, {'cui': 'C0429629', 'cui_str': 'Total energy expenditure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0206054', 'cui_str': 'Transesophageal echocardiography'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",,0.0507135,"Passive heating did not alter blood [glucose] (CON, 1,677 (386) a.u.; HOT-OGTT, 1,797 (340) a.u.; OGTT-HOT, 1,662 (364) a.u.; P = 0.28), insulin sensitivity (P = 0.15), or SBP (P = 0.18), but did increase [eHSP70] in both heating conditions (CON, 203.48 (110.81)","[{'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'James', 'Affiliation': 'School of Sport, Health and Exercise Science, Faculty of Science and Health, University of Portsmouth, United Kingdom.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Corbett', 'Affiliation': 'School of Sport, Health and Exercise Science, Faculty of Science and Health, University of Portsmouth, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cummings', 'Affiliation': 'Diabetes and Endocrinology Department, Portsmouth Hospitals University NHS Trust, Portsmouth, United Kingdom.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Allard', 'Affiliation': 'Diabetes and Endocrinology Department, Portsmouth Hospitals University NHS Trust, Portsmouth, United Kingdom.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Young', 'Affiliation': 'School of Pharmacy and Biomedical Sciences, Faculty of Science and Health, University of Portsmouth, United Kingdom.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Towse', 'Affiliation': 'School of Pharmacy and Biomedical Sciences, Faculty of Science and Health, University of Portsmouth, United Kingdom.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Carey-Jones', 'Affiliation': 'School of Biological Sciences, Faculty of Science and Health, University of Portsmouth, United Kingdom.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Eglin', 'Affiliation': 'School of Sport, Health and Exercise Science, Faculty of Science and Health, University of Portsmouth, United Kingdom.'}, {'ForeName': 'Billy', 'Initials': 'B', 'LastName': 'Hopkins', 'Affiliation': 'School of Sport, Health and Exercise Science, Faculty of Science and Health, University of Portsmouth, United Kingdom.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Morgan', 'Affiliation': 'School of Sport, Health and Exercise Science, Faculty of Science and Health, University of Portsmouth, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tipton', 'Affiliation': 'School of Sport, Health and Exercise Science, Faculty of Science and Health, University of Portsmouth, United Kingdom.'}, {'ForeName': 'Zoe L', 'Initials': 'ZL', 'LastName': 'Saynor', 'Affiliation': 'School of Sport, Health and Exercise Science, Faculty of Science and Health, University of Portsmouth, United Kingdom.'}, {'ForeName': 'Anthony I', 'Initials': 'AI', 'LastName': 'Shepherd', 'Affiliation': 'School of Sport, Health and Exercise Science, Faculty of Science and Health, University of Portsmouth, United Kingdom.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00747.2020'] 1850,33418383,Deep learning trained algorithm maintains the quality of half-dose contrast-enhanced liver computed tomography images: Comparison with hybrid iterative reconstruction: Study for the application of deep learning noise reduction technology in low dose.,"PURPOSE This study compares the image and diagnostic qualities of a DEep Learning Trained Algorithm (DELTA) for half-dose contrast-enhanced liver computed tomography (CT) with those of a commercial hybrid iterative reconstruction (HIR) method used for standard-dose CT (SDCT). METHODS This study enrolled 207 adults, and they were divided into two groups: SDCT and low-dose CT (LDCT). SDCT was reconstructed using the HIR method (SDCT HIR ), and LDCT was reconstructed using both the HIR method (LDCT HIR ) and DELTA (LDCT DL ). Noise, Hounsfield unit (HU) values, signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) were compared between three image series. Two radiologists assessed the noise, artefacts, overall image quality, visualisation of critical anatomical structures and lesion detection, characterisation and visualisation. RESULTS The mean effective doses were 5.64 ± 1.96 mSv for SDCT and 2.87 ± 0.87 mSv for LDCT. The noise of LDCT DL was significantly lower than that of SDCT HIR and LDCT HIR . The SNR and CNR of LDCT DL were significantly higher than those of the other two groups. The overall image quality, visualisation of anatomical structures and lesion visualisation between LDCT DL and SDCT HIR were not significantly different. For lesion detection, the sensitivities and specificities of SDCT HIR vs. LDCT DL were 81.9 % vs. 83.7 % and 89.1 % vs. 86.3 %, respectively, on a per-patient basis. SDCT HIR showed 75.4 % sensitivity and 82.6 % specificity for lesion characterisation on a per-patient basis, whereas LDCT DL showed 73.5 % sensitivity and 82.4 % specificity. CONCLUSIONS LDCT with DELTA had approximately 49 % dose reduction compared with SDCT with HIR while maintaining image quality on contrast-enhanced liver CT.",2021,"The overall image quality, visualisation of anatomical structures and lesion visualisation between LDCT DL and SDCT HIR were not significantly different.",['enrolled 207 adults'],"['SDCT and low-dose CT (LDCT', 'commercial hybrid iterative reconstruction (HIR) method used for standard-dose CT (SDCT', 'SDCT with HIR', 'DEep Learning Trained Algorithm (DELTA) for half-dose contrast-enhanced liver computed tomography (CT']","['Noise, Hounsfield unit (HU) values, signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR', 'noise, artefacts, overall image quality, visualisation of critical anatomical structures and lesion detection, characterisation and visualisation', 'overall image quality, visualisation of anatomical structures and lesion visualisation between LDCT DL and SDCT HIR', 'mean effective doses', 'image quality on contrast-enhanced liver CT', 'noise of LDCT DL', 'SNR and CNR of LDCT DL', 'sensitivities and specificities of SDCT HIR vs. LDCT DL']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}]","[{'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0085089', 'cui_str': 'Artifact'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0700276', 'cui_str': 'Anatomical structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}]",207.0,0.0215427,"The overall image quality, visualisation of anatomical structures and lesion visualisation between LDCT DL and SDCT HIR were not significantly different.","[{'ForeName': 'Lingming', 'Initials': 'L', 'LastName': 'Zeng', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Zeng', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Wanlin', 'Initials': 'W', 'LastName': 'Peng', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Jinge', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Sixian', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Keling', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Chunchao', 'Initials': 'C', 'LastName': 'Xia', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Zhenlin', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China. Electronic address: lzlcd01@126.com.'}]",European journal of radiology,['10.1016/j.ejrad.2020.109487'] 1851,33421747,Acute effects of alcohol on resting-state functional connectivity in healthy young men.,"Alcohol abuse and dependence remain significant public health issues, and yet the brain circuits that are involved in the rewarding effects of alcohol are poorly understood. One promising way to study the effects of alcohol on neural activity is to examine its effects on functional connectivity between brain areas involved in reward and other functions. Here, we compared the effects of two doses of alcohol (0.4 and 0.8 g/kg) to placebo on resting-state functional connectivity in brain circuits related to reward in 19 healthy young men without histories of alcohol problems. The higher, but not the lower, dose of alcohol, significantly increased connectivity from reward-related regions to sensory and motor cortex, and between seeds associated with cognitive control. Contrary to expectation, alcohol did not significantly change connectivity for the ventral striatum at either dose. These findings reveal unrecognized effects of alcohol on connectivity from reward-related regions to visual and sensory cortical areas.",2021,"The higher, but not the lower, dose of alcohol, significantly increased connectivity from reward-related regions to sensory and motor cortex, and between seeds associated with cognitive control.","['19 healthy young men without histories of alcohol problems', 'healthy young men']","['alcohol', 'placebo']",['resting-state functional connectivity'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0549393', 'cui_str': 'Alcohol problem'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",19.0,0.0231636,"The higher, but not the lower, dose of alcohol, significantly increased connectivity from reward-related regions to sensory and motor cortex, and between seeds associated with cognitive control.","[{'ForeName': 'Jiaxu', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, United States. Electronic address: hanjiaxu@uchicago.edu.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Keedy', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, United States. Electronic address: skeedy@bsd.uchicago.edu.'}, {'ForeName': 'Conor H', 'Initials': 'CH', 'LastName': 'Murray', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, United States. Electronic address: chmurray@uchicago.edu.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Foxley', 'Affiliation': 'Department of Radiology, University of Chicago, United States. Electronic address: foxley@uchicago.edu.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, United States. Electronic address: hdew@uchicago.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106786'] 1852,33481452,Local Anesthesia Injection in Upper Blepharoplasty Surgery: A Side at a Time or Both Sides at Once? A Prospective Randomized Study.,"BACKGROUND Perceived pain during local anesthesia injections can be effected by the injection sequence. OBJECTIVE We sought to compare pain levels during local anesthesia injections during upper lid blepharoplasty (ULB) using 2 surgical sequences. MATERIALS AND METHODS We conducted a prospective, randomized clinical trial. Patients with ULB were randomized to either have local anesthesia injection followed by ULB in the right eyelid and then in the left (Group A) or to have local anesthesia injection to both eyelids followed by ULB on both eyelids (Group B). Pain was assessed using a visual analog scale (VAS) for pain score of 0 to 10. RESULTS Forty patients were included and randomized. The mean VAS score in Group A was 2.60 ± 1.84 and 3.30 ± 1.62 (right and left, respectively, p value = .035). The mean VAS score in Group B was 2.55 ± 1.63 and 2.80 ± 1.67 (right and left eyelids, respectively, p value = .258). No intergroup difference in pain was found. CONCLUSION Patients having sequential anesthesia during ULB perceived more pain on injection to the second eyelid, whereas patients having local anesthesia followed by ULB perceived the same amount of pain in both eyes. Pain levels in both groups were similar. Local anesthesia injections in both groups were well tolerated.",2021,"The mean VAS score in Group B was 2.55 ± 1.63 and 2.80 ± 1.67 (right and left eyelids, respectively, p value = .258).","['Upper Blepharoplasty Surgery', 'Patients with ULB', 'Forty patients were included and randomized']","['Local Anesthesia Injection', 'local anesthesia injections during upper lid blepharoplasty (ULB', 'local anesthesia injection followed by ULB in the right eyelid and then in the left (Group A) or to have local anesthesia injection to both eyelids followed by ULB on both eyelids', 'Local anesthesia injections']","['visual analog scale (VAS) for pain score', 'Pain levels', 'Pain', 'mean VAS score', 'tolerated', 'pain', 'pain levels']","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0197213', 'cui_str': 'Repair of eyelid'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0197213', 'cui_str': 'Repair of eyelid'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0015426', 'cui_str': 'Eyelid structure'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",40.0,0.0692731,"The mean VAS score in Group B was 2.55 ± 1.63 and 2.80 ± 1.67 (right and left eyelids, respectively, p value = .258).","[{'ForeName': 'Oded', 'Initials': 'O', 'LastName': 'Ohana', 'Affiliation': 'Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami, Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Ayala-Haedo', 'Affiliation': 'South Florida Eye Institute, Miami, Florida.'}, {'ForeName': 'Apostolos', 'Initials': 'A', 'LastName': 'Anagnostopolous', 'Affiliation': 'Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami, Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Wendy W', 'Initials': 'WW', 'LastName': 'Lee', 'Affiliation': 'Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami, Miller School of Medicine, Miami, Florida.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002718'] 1853,33432600,The effect of reverse Trendelenburg position versus semi-recumbent position on respiratory parameters of obese critically ill patients: A randomised controlled trial.,"AIMS AND OBJECTIVES To investigate the effect of reverse Trendelenburg position versus semi-recumbent position on respiratory parameters of obese critically ill patients. BACKGROUND Reverse Trendelenburg position is recommended for obese patients; however, the effect among critically ill patients, especially those on mechanical ventilation, has limited study. DESIGN Randomised, controlled pretest, repeated post-test trial with two parallel groups. METHODS The study started from 13 January 2020-12 March 2020. Adult critically ill patients with a body mass index ≥30 were randomly assigned by computer-generated randomisation to either reverse Trendelenburg position group (intervention) or semi-recumbent position group (active comparator control). Outcome measures were ventilation parameters (dynamic compliance, partial pressure of arterial carbon dioxide and minute volume) and oxygenation parameters (hypoxaemic index and partial pressure of arterial oxygen). Measures were assessed immediately before positioning and after positioning in 10 minutes, 20 minutes and 30 minutes. CONSORT checklist was used to report the current study. SETTINGS Four general intensive care units. RESULTS One hundred and ten patients (55 patients in each group) completed the study. The reverse Trendelenburg position group had a higher improvement than the semi-recumbent position group as estimated by mean differences in their dynamic compliance, minute volume, partial pressure of carbon dioxide, partial pressure of oxygen and hypoxaemic index. CONCLUSION Reverse Trendelenburg position improves obese patients' respiratory parameters more than semi-recumbent position. RELEVANCE TO CLINICAL PRACTICE This study directs nurses to use the reverse Trendelenburg position, which is an important position for enhancing the parameters of ventilation and oxygenation of obese mechanically ventilated patients.",2021,"The reverse Trendelenburg position group had a higher improvement than the semi-recumbent position group as estimated by mean differences in their dynamic compliance, minute volume, partial pressure of carbon dioxide, partial pressure of oxygen and hypoxaemic index. ","['Four general intensive care units', 'obese patients', 'One hundred and ten patients (55 patients in each group) completed the study', 'Adult critically ill patients with a body mass index ≥30', 'obese critically ill patients', 'obese mechanically ventilated patients', '13 January 2020-12 March 2020']","['computer-generated randomisation to either reverse Trendelenburg position group (intervention) or semi-recumbent position group (active comparator control', 'reverse Trendelenburg position versus semi-recumbent position', 'Reverse Trendelenburg position']","['ventilation parameters (dynamic compliance, partial pressure of arterial carbon dioxide and minute volume) and oxygenation parameters (hypoxaemic index and partial pressure of arterial oxygen', 'dynamic compliance, minute volume, partial pressure of carbon dioxide, partial pressure of oxygen and hypoxaemic index']","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0277813', 'cui_str': 'Inverse Trendelenburg position'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444391', 'cui_str': 'Semi-recumbent position'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0429680', 'cui_str': 'Dynamic compliance'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0428679', 'cui_str': 'Minute volume'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}]",,0.109267,"The reverse Trendelenburg position group had a higher improvement than the semi-recumbent position group as estimated by mean differences in their dynamic compliance, minute volume, partial pressure of carbon dioxide, partial pressure of oxygen and hypoxaemic index. ","[{'ForeName': 'Eman Arafa', 'Initials': 'EA', 'LastName': 'Hassan', 'Affiliation': 'Lecturer of Critical Care and Emergency Nursing, Department of Critical Care and Emergency Nursing, Faculty of Nursing, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Azza Abd Elrazek', 'Initials': 'AAE', 'LastName': 'Baraka', 'Affiliation': 'Lecturer of Critical Care and Emergency Nursing, Department of Critical Care and Emergency Nursing, Faculty of Nursing, Alexandria University, Alexandria, Egypt.'}]",Journal of clinical nursing,['10.1111/jocn.15645'] 1854,33487626,Effects of participatory workplace improvement program on stress-related biomarkers and self-reported stress among university hospital nurses: a preliminary study.,"Although participatory workplace improvement programs are known to provide favorable effects on high stress occupations like nursing, no studies have confirmed its effect using biomarkers. The aim of this study was to determine whether a participatory workplace improvement program would decrease stress-related symptoms as evaluated by biomarkers and self-reported stress among hospital nurses. Three actions to alleviate job stress, which were determined through focus group interviews and voting, were undertaken for two months. A total of 31 female Japanese nurses underwent measurement of inflammatory markers, autonomic nervous activity (ANA), and perceived job stress (PJS) at three-time points; before the program (T1), within a week after the completion of the program (T2), and three months after the program (T3). A series of inflammatory markers (Interferon-γ, Interleukin (IL)-6, and IL-12/23p40) decreased significantly at T2, and IL-12/23p40 and IL-15 significantly decreased at T3 compared to T1, while ANA and PJS remained unchanged. Our participatory program exerted beneficial effects in reducing inflammatory responses, but not for ANA and PJS. Further investigations with a better study design, i.e., a randomized controlled trial, and a larger sample size are warranted to determine what exerted beneficial effects on inflammatory markers and why other outcomes remained unchanged.",2021,"A series of inflammatory markers (Interferon-γ, Interleukin (IL)-6, and IL-12/23p40) decreased significantly at T2, and IL-12/23p40 and IL-15 significantly decreased at T3 compared to T1, while ANA and PJS remained unchanged.","['31 female Japanese nurses', 'university hospital nurses']",['participatory workplace improvement program'],"['inflammatory markers (Interferon-γ, Interleukin (IL)-6, and IL-12/23p40', 'inflammatory markers, autonomic nervous activity (ANA), and perceived job stress (PJS', 'stress-related biomarkers and self-reported stress', 'IL-12/23p40 and IL-15']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0027769', 'cui_str': 'Nervousness'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0254610', 'cui_str': 'Interleukin 15'}]",31.0,0.0278876,"A series of inflammatory markers (Interferon-γ, Interleukin (IL)-6, and IL-12/23p40) decreased significantly at T2, and IL-12/23p40 and IL-15 significantly decreased at T3 compared to T1, while ANA and PJS remained unchanged.","[{'ForeName': 'Tsukumi', 'Initials': 'T', 'LastName': 'Tondokoro', 'Affiliation': 'Graduate School of Medicine, International University of Health and Welfare, Japan.'}, {'ForeName': 'Akinori', 'Initials': 'A', 'LastName': 'Nakata', 'Affiliation': 'Graduate School of Medicine, International University of Health and Welfare, Japan.'}, {'ForeName': 'Yasumasa', 'Initials': 'Y', 'LastName': 'Otsuka', 'Affiliation': 'Faculty of Human Sciences, University of Tsukuba, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Yanagihara', 'Affiliation': 'Faculty of Food Science and Nutrition, Kyushu Nutrition Welfare University, Japan.'}, {'ForeName': 'Ayumi', 'Initials': 'A', 'LastName': 'Anan', 'Affiliation': 'School of Health Sciences, University of Occupational and Environmental Health, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Kodama', 'Affiliation': 'School of Health Sciences, University of Occupational and Environmental Health, Japan.'}, {'ForeName': 'Noriaki', 'Initials': 'N', 'LastName': 'Satoh', 'Affiliation': 'Shared-Use Research Center, University of Occupational and Environmental Health, Japan.'}]",Industrial health,['10.2486/indhealth.2020-0176'] 1855,33486295,Tailoring a dissonance-based body image intervention for adult women in a proof of concept trial: The Women's Body Initiative.,"Although historically conceptualized as problems of youth, recent research indicates that women of all ages experience body dissatisfaction and eating disorder (ED) pathology. Despite this, existing body image interventions predominantly target youth. The Body Project (BP) has extensive support for reducing ED risk factors in younger women and girls. The current proof-of-concept study investigated the feasibility, acceptability, and estimates of intervention effect sizes of a modified BP for adult women, the Women's Body Initiative (WBI). Conducted in the Southwestern United States, adult women (N = 13) aged 29-70 (M = 49.1) participated in 4, 1-h weekly sessions, completing measures at baseline, post-intervention, and 3-month follow-up. Participants rated the program as highly feasible and acceptable. Within-subjects effects sizes were medium to large for primary outcomes (body dissatisfaction, ED pathology) and secondary outcomes (psychosocial impairment, negative affect, quality of life, nutritious food consumption, and sleep) through 3-months. Results suggest preliminary feasibility and acceptability of WBI for adult women, and support proceeding with a larger trial to investigate intervention efficacy.",2021,"Within-subjects effects sizes were medium to large for primary outcomes (body dissatisfaction, ED pathology) and secondary outcomes (psychosocial impairment, negative affect, quality of life, nutritious food consumption, and sleep) through 3-months.","['Southwestern United States, adult women (N\u202f=\u202f13) aged 29-70 (M\u202f=\u202f49.1', 'adult women', 'younger women and girls', ""adult women, the Women's Body Initiative (WBI""]",['dissonance-based body image intervention'],"['secondary outcomes (psychosocial impairment, negative affect, quality of life, nutritious food consumption, and sleep']","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}]","[{'cui': 'C0009242', 'cui_str': 'Cognitive Dissonance'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453857', 'cui_str': 'Nutritious food'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]",,0.0711087,"Within-subjects effects sizes were medium to large for primary outcomes (body dissatisfaction, ED pathology) and secondary outcomes (psychosocial impairment, negative affect, quality of life, nutritious food consumption, and sleep) through 3-months.","[{'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Verzijl', 'Affiliation': 'Department of Psychology, University of South Florida, 4202 East Fowler Ave, Tampa, FL, 33620, United States. Electronic address: cverzijl@usf.edu.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Duan', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr. MC 7792, San Antonio, TX, 78229, United States.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Wilfred', 'Affiliation': 'Department of Psychology, University of Missouri Kansas City, 5030 Cherry Street, Kansas City, MO, 64110, United States.'}, {'ForeName': 'C B', 'Initials': 'CB', 'LastName': 'Becker', 'Affiliation': 'Department of Psychology, Trinity University, One Trinity Place, San Antonio, TX, 78212, United States.'}, {'ForeName': 'L S', 'Initials': 'LS', 'LastName': 'Kilpela', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr. MC 7792, San Antonio, TX, 78229, United States; Barshop Institute for Longevity and Aging Studies, University of Texas Health Science Center, 8403 Floyd Curl Drive, San Antonio, TX, 78229, United States; Center for Research to Advance Community Health, University of Texas Health Science Center, 7411 John Smith Road, San Antonio, TX, 78229, United States.'}]",Body image,['10.1016/j.bodyim.2021.01.001'] 1856,33492899,Oral Versus Long-Acting Injectable Antipsychotic Treatment for People With Severe Schizophrenia: A 5-Year Follow-up of Effectiveness.,"ABSTRACT The objective here is to compare the effectiveness of long-acting injectable antipsychotics (LAI-APs) and oral ones (OAPs) in patients with severe (Global Clinical Impression-Severity ≥ 5) schizophrenia (N = 688). A 5-year follow-up study has been conducted in patients undergoing standard treatment in mental health units (MHUs) or on a severe mental illness program (SMIP). A total of 8.7% of the patients on the SMIP discontinued treatment, whereas 43.6% did so in MHUs (p < 0.0001). In both cases, treatment retention was significantly higher in patients on LAI-APs (p < 0.001). Also, hospital admissions were in both cases fewer among those on LAI-APs (p < 0.001). There was a significant link between suicide attempts and OAP treatment (p < 0.01). Given the relationship between the use of LAI-APs versus oral treatments in achieving higher adherence and less relapses and suicide attempts, the use of second-generation antipsychotics LAIs should be considered more suitable for people with severe schizophrenia.",2021,"In both cases, treatment retention was significantly higher in patients on LAI-APs (p < 0.001).","['patients with severe (Global Clinical Impression-Severity ≥ 5) schizophrenia (N = 688', 'People With Severe Schizophrenia', 'patients undergoing standard treatment in mental health units (MHUs) or on a severe mental illness program (SMIP', 'people with severe schizophrenia']","['Oral Versus Long-Acting Injectable Antipsychotic Treatment', 'LAI-APs', 'long-acting injectable antipsychotics (LAI-APs) and oral ones (OAPs']","['treatment retention', 'suicide attempts and OAP treatment', 'hospital admissions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0069290', 'cui_str': 'OAP protocol'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt'}, {'cui': 'C0069290', 'cui_str': 'OAP protocol'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",688.0,0.0262027,"In both cases, treatment retention was significantly higher in patients on LAI-APs (p < 0.001).","[{'ForeName': 'Juan J', 'Initials': 'JJ', 'LastName': 'Fernández-Miranda', 'Affiliation': ''}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Díaz-Fernández', 'Affiliation': ''}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'López-Muñoz', 'Affiliation': ''}]",The Journal of nervous and mental disease,['10.1097/NMD.0000000000001299'] 1857,33492021,Effect of Case Management on HIV Outcomes for Community Corrections Population: Results of an 18-Month Randomized Controlled Trial.,"BACKGROUND Evidence-based interventions that engage community-dwelling, justice-involved, people living with HIV (PLWH) in care are urgently needed. Project Bridge, an intensive case management intervention, has demonstrated efficacy for linking PLWH to care transitioning from prison to the community. We assessed whether a modified Project Bridge model was effective for increasing rates of HIV treatment engagement, antiretroviral therapy receipt, and adherence for community-dwelling individuals supervised on probation and parole. SETTING Baltimore, Maryland. METHODS In this study, the 18-month outcomes of a randomized controlled trial in which PLWH were also on probation or parole received either Project Bridge (n = 50) or treatment as usual (n = 50) were assessed. HIV treatment engagement (primary outcome), antiretroviral therapy prescription, and adherence (secondary outcomes) are evaluated using the intent-to-treat approach. RESULTS There were no statistically significant differences in rates of HIV treatment engagement, antiretroviral therapy prescription receipt, or adherence between groups over the 18-month study period. Across groups, participants were 5.6 times more likely to receive HIV care, 5.8 times more likely to receive an antiretroviral therapy prescription, and 4 times more likely to report antiretroviral therapy adherence at each follow-up period. CONCLUSIONS Future research is needed to identify potentially less-intensive interventions that target the unique needs of PLWH under community supervision.",2021,"There were no statistically significant differences in rates of HIV treatment engagement, antiretroviral therapy prescription receipt or adherence between groups over the 18-month study period.","['community-dwelling individuals supervised on probation and parole', 'community corrections population', 'Baltimore, Maryland']","['PLWH', 'Project Bridge']","['antiretroviral therapy prescription and adherence (secondary outcomes', 'report ART adherence', 'HIV outcomes', 'rates of HIV treatment engagement, antiretroviral therapy prescription receipt or adherence']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0425169', 'cui_str': 'On probation'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]",50.0,0.247753,"There were no statistically significant differences in rates of HIV treatment engagement, antiretroviral therapy prescription receipt or adherence between groups over the 18-month study period.","[{'ForeName': 'Erika L', 'Initials': 'EL', 'LastName': 'Crable', 'Affiliation': 'Department of Medicine, Evans Center for Implementation and Improvement Sciences, Boston University School of Medicine, Boston, MA.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Blue', 'Affiliation': 'Friends Research Institute, Baltimore, MD.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'McKenzie', 'Affiliation': 'The Miriam Hospital, Providence, RI; and.'}, {'ForeName': 'Josiah D', 'Initials': 'JD', 'LastName': 'Rich', 'Affiliation': 'The Miriam Hospital, Providence, RI; and.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Gordon', 'Affiliation': 'Friends Research Institute, Baltimore, MD.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002624'] 1858,33491327,Impact of cold and flu medication on obstructive sleep apnoea and its underlying traits: A pilot randomized controlled trial.,"BACKGROUND AND OBJECTIVE Animal studies indicate that alpha-1 adrenergic receptor agonists and antimuscarinic agents improve genioglossus muscle activity during sleep and may be candidates for the pharmacological treatment of OSA. On the other hand, noradrenergic stimulants may be wake-promoting or cause insomnia symptoms if taken before bedtime, and the addition of a medication with sedative properties, such as an antihistaminic, may reduce these side effects. In this study, we aimed to determine the effects of the combination of an alpha-1 adrenergic agonist (pseudoephedrine) and an antihistaminic-antimuscarinic (diphenhydramine) on OSA severity (AHI), genioglossus responsiveness and other endotypic traits (V passive , muscle compensation, LG and arousal threshold). METHODS Ten OSA patients performed a randomized, placebo-controlled, double-blind, crossover trial comparing one night of pseudoephedrine 120 mg plus diphenhydramine 50 mg (DAW1033D) to placebo administered prior to sleep. The AHI, genioglossus muscle responsiveness to negative oesophageal pressure and the endotypic traits were measured via PSG. RESULTS The participants' median (interquartile range) age was 50 (46-53) years and body mass index (BMI) was 34.3 (30.6-39.2) kg/m 2 . The drug combination had no effect on AHI (21.6 (9.1-49.8) on placebo vs 37.9 (5.1-55.4) events/h on DAW1033D, P > 0.5) or genioglossus responsiveness (6.0 (2.6-9.2) on placebo vs 4.0 (3.5-7.3) %/cm H 2 O). Amongst the phenotypic traits, only V passive was improved by 29 (3-55) % eupnoea, P = 0.03 (mean (95% CI)). CONCLUSION The combination of pseudoephedrine and diphenhydramine did not improve OSA severity or genioglossus responsiveness but induced a small improvement in upper airway collapsibility, possibly due to the decongestant effect of the medications. The results of this study do not support the use of these medications for OSA treatment.",2021,"The combination of pseudoephedrine and diphenhydramine did not improve OSA severity or genioglossus responsiveness but induced a small improvement in upper airway collapsibility, possibly due to the decongestant effect of the medications.","[""participants' median (interquartile range) age was 50 (46-53) years and body mass index (BMI) was 34.3 (30.6-39.2) kg/m 2 "", 'Ten OSA patients']","['pseudoephedrine 120\u2009mg plus diphenhydramine 50\u2009mg (DAW1033D) to placebo', 'alpha-1 adrenergic agonist (pseudoephedrine', 'placebo', 'cold and flu medication', 'antihistaminic-antimuscarinic (diphenhydramine', 'pseudoephedrine and diphenhydramine']","['OSA severity (AHI), genioglossus responsiveness and other endotypic traits (V passive , muscle compensation, LG and arousal threshold', 'genioglossus responsiveness', 'AHI, genioglossus muscle responsiveness to negative oesophageal pressure and the endotypic traits', 'OSA severity or genioglossus responsiveness', 'obstructive sleep apnoea', 'V passive', 'AHI']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0989415', 'cui_str': 'Pseudoephedrine 120 MG'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0012522', 'cui_str': 'Diphenhydramine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0001648', 'cui_str': 'Adrenergic receptor agonist'}, {'cui': 'C0033798', 'cui_str': 'Pseudoephedrine'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}]","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C0224194', 'cui_str': 'Structure of genioglossus muscle'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0152057', 'cui_str': 'Compensation'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0232531', 'cui_str': 'Esophageal pressure'}]",10.0,0.334397,"The combination of pseudoephedrine and diphenhydramine did not improve OSA severity or genioglossus responsiveness but induced a small improvement in upper airway collapsibility, possibly due to the decongestant effect of the medications.","[{'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Taranto-Montemurro', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine and Neurology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Sands', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine and Neurology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Azarbarzin', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine and Neurology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Calianese', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine and Neurology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Vena', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine and Neurology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Hess', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine and Neurology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Sang-Wook', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine and Neurology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'White', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine and Neurology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wellman', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine and Neurology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}]","Respirology (Carlton, Vic.)",['10.1111/resp.14009'] 1859,33295690,A pediatric high-flow nasal cannula protocol standardizes initial flow and expedites weaning.,"OBJECTIVE Respiratory illnesses compose the most common diagnoses of patients admitted to pediatric intensive care units. In pediatrics, high-flow nasal cannula (HFNC) therapy is an intermediate level of respiratory support with variability in practice. We conducted a pre-post intervention study of patients placed on HFNC therapy before and after the implementation of an HFNC protocol. METHODS This was a quality improvement/pre-post intervention study of pediatric patients who received HFNC therapy in our teaching, tertiary care children's hospital between January 2015 and April 2019. Patients were evaluated before and after the implementation of a protocol that promoted initiation of higher flow and rapid weaning. Our primary outcomes were initial flow and rate of weaning pre- and post-protocol; our secondary outcomes were HFNC failure rate (defined as escalation to noninvasive ventilation or mechanical ventilation) and length of hospital stay. Propensity matching was used to account for differences in age and weight pre- and post-protocol. RESULTS In total, 584 patients were included, 292 pre-protocol, and 292 post-protocol. The median age was 20 months, and the indication for HFNC therapy was bronchiolitis in 29% of patients. Post-protocol patients compared to pre-protocol patients had significantly a higher initial flow (median 14.5 L/min vs. 10 L/min, p < .001) and a higher weaning rate of flow (median 4.1 L/min/h vs. 2.4 L/min/h, p < .001). Post-protocol patients also had a lower HFNC failure rate (10% vs. 17%, p = .015) and a shorter length of stay (5.97 days vs. 6.80 days, p = .006). CONCLUSION Among pediatric patients, the implementation of an HFNC protocol increases initial flow, allows for more rapid weaning, and may decrease the incidence of escalation to noninvasive ventilation or mechanical ventilation.",2021,"Post-protocol patients also had a lower HFNC failure rate (10% vs. 17%, p = .015) and a shorter length of stay (5.97 days vs. 6.80 days, p = .006). ","['patients admitted to pediatric intensive care units', '584 patients were included, 292 pre-protocol,\xa0and 292 post-protocol', ""pediatric patients who received HFNC therapy in our teaching, tertiary care children's hospital between January 2015 and April 2019"", 'pediatric patients', 'patients placed on HFNC therapy before and after the implementation of an\xa0HFNC protocol']",['high-flow nasal cannula (HFNC) therapy'],"['higher initial flow', 'HFNC failure rate', 'weaning rate of flow', 'shorter length of stay', 'initial flow and rate of weaning pre- and post-protocol; our secondary outcomes were HFNC failure rate (defined as escalation to noninvasive ventilation or mechanical ventilation) and length of hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0442504', 'cui_str': 'Place'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",584.0,0.128936,"Post-protocol patients also had a lower HFNC failure rate (10% vs. 17%, p = .015) and a shorter length of stay (5.97 days vs. 6.80 days, p = .006). ","[{'ForeName': 'Robert K', 'Initials': 'RK', 'LastName': 'Wiser', 'Affiliation': 'Department of Pediatrics, Arnold Palmer Hospital for Children, Orlando, Florida, USA.'}, {'ForeName': 'Ashlee C', 'Initials': 'AC', 'LastName': 'Smith', 'Affiliation': 'Department of Pediatrics, Arnold Palmer Hospital for Children, Orlando, Florida, USA.'}, {'ForeName': 'Bertha B', 'Initials': 'BB', 'LastName': 'Khallouq', 'Affiliation': 'Department of Pediatrics, Arnold Palmer Hospital for Children, Orlando, Florida, USA.'}, {'ForeName': 'Jerome G', 'Initials': 'JG', 'LastName': 'Chen', 'Affiliation': 'Department of Pediatrics, Arnold Palmer Hospital for Children, Orlando, Florida, USA.'}]",Pediatric pulmonology,['10.1002/ppul.25214'] 1860,33403688,Newborn infants who received skin-to-skin contact with fathers after Caesarean sections showed stable physiological patterns.,"AIM Separating infants and their parents after a Caesarean section is still the routine care worldwide. This study investigated three caregiving models on the wakefulness and physiological parameters of full-term infants after an elective Caesarean section. METHODS Newborn infants born in a Chilean public hospital in 2009-12 were randomised to three groups: cot, fathers' arms or skin-to-skin contact with their father. They were assessed at 15-minute intervals, from 45 to 120 minutes after the Caesarean section. Their physiological parameters were measured, and their wakefulness was assessed using the Neonatal Behavioural Assessment Scale. RESULTS We studied 95 infant (53% girls) born at a mean gestational age of 38.9 ± 0.9 weeks. Heart rates were significantly higher in the skin-to-skin than cot or fathers' arms groups and showed greater stability over time. Wakefulness was initially higher in the skin-to-skin group, but there were no significant differences by the end of the observation. There were no differences between the groups in peripheral oxygen saturation. Skin-to-skin contact had no negative impact on the infants. CONCLUSION The skin-to-skin group showed some advantages over the cot and fathers' arms groups when it came to establishing stable physiological parameters and wakefulness. This approach should be supported during mother-infant separation.",2021,Heart rates were significantly higher in the skin-to-skin than cot or fathers' arms groups and showed greater stability over time.,"['Newborn infants born in a Chilean public hospital in 2009-12', '95 infant (53% girls) born at a mean gestational age of 38.9\xa0±\xa00.9\xa0weeks', 'full-term infants after an elective Caesarean section', 'Newborn infants who received skin-to-skin contact with fathers after Caesarean sections']",['skin-to-skin contact with their father'],"['Neonatal Behavioural Assessment Scale', 'Wakefulness', 'stable physiological patterns', 'peripheral oxygen saturation', 'Heart rates']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4551581', 'cui_str': 'Term baby'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0015671', 'cui_str': 'Father'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1160858', 'cui_str': 'Behavior assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",95.0,0.0191501,Heart rates were significantly higher in the skin-to-skin than cot or fathers' arms groups and showed greater stability over time.,"[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ayala', 'Affiliation': ""Department of Women's and Children's Health, Division Reproductive Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Kyllike', 'Initials': 'K', 'LastName': 'Christensson', 'Affiliation': ""Department of Women's and Children's Health, Division Reproductive Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Christensson', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Cavada', 'Affiliation': 'School of Public Health, Faculty of Medicine University of Chile, Santiago, Chile.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Erlandsson', 'Affiliation': ""Department of Women's and Children's Health, Division Reproductive Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Velandia', 'Affiliation': 'School of Health, Care and Social Welfare, Mälardalen University, Västerås, Sweden.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15685'] 1861,33409974,Comparison of 12-Week Fitness Protocols Following Bariatric Surgery: Aerobic Exercise Versus Aerobic Exercise and Progressive Resistance.,"BACKGROUND Successful bariatric surgery outcomes are better maintained with an exercise program. This pilot study compared the effects on short-term functional capacity and body composition of 2 post-bariatric surgery home-based programs: aerobic exercise alone versus aerobic exercise combined with progressive resistance conditioning. METHODS Laboratory measures and self-assessments of post-bariatric surgery patients (BMI ≥ 30 kg/m 2 ) undergoing either aerobic exercise (AE group) or aerobic + progressive-resistance exercise (AEPR group) were compared at postoperative months 1 and 3. Anthropometric characteristic changes were recorded, as well as changes in functional capacity (e.g., 6-min walking test), muscle strength (e.g., hand grip strength test; five-times-sit-to-stand test), and quality of life (i.e., Beck Depression Inventory). RESULTS Between July 2018 and March 2019, 35 patients completed the AE (n = 17) or AEPR (n = 18) program. The AEPR group lost statistically significantly more weight (mean 2.2 kg) relative to baseline than the AE group (p < 0.05). The AEPR group achieved significantly greater mean total muscle, liquid, and bone mass; upper-extremity muscle strength; uric acid levels; body fat loss; and performed better on the 6-min walking test (all p < 0.05). In month 3, the AEPR group achieved a greater mean walking distance (p = 0.029) and O 2 saturation related to dyspnea (p = 0.001) than the AE group. Group quality of life scores were comparable. CONCLUSIONS In a comparative 12-week post-bariatric surgery study, both aerobic exercise alone and aerobic exercise plus progressive-resistance training were positively correlated with general health improvement. However, the progressive-resistance regimen resulted in significantly greater weight loss, functional capacity, muscle mass, and upper-body strength.",2021,"In month 3, the AEPR group achieved a greater mean walking distance (p = 0.029) and O 2 saturation related to dyspnea (p = 0.001) than the AE group.","['Between July 2018 and March 2019', 'Bariatric Surgery', '35 patients completed the AE (n\u2009=\u200917) or', 'Laboratory measures and self-assessments of post-bariatric surgery patients (BMI\u2009≥\u200930\xa0kg/m 2 ) undergoing either']","['aerobic exercise alone and aerobic exercise plus progressive-resistance training', 'Aerobic Exercise Versus Aerobic Exercise and Progressive Resistance', 'aerobic exercise (AE group) or aerobic + progressive-resistance exercise (AEPR group', 'short-term functional capacity and body composition of 2 post-bariatric surgery home-based programs: aerobic exercise alone versus aerobic exercise combined with progressive resistance conditioning', 'AEPR']","['weight', 'Anthropometric characteristic changes', 'functional capacity (e.g., 6-min walking test), muscle strength (e.g., hand grip strength test; five-times-sit-to-stand test), and quality of life (i.e., Beck Depression Inventory', 'weight loss, functional capacity, muscle mass, and upper-body strength', 'Group quality of life scores', 'mean total muscle, liquid, and bone mass; upper-extremity muscle strength; uric acid levels; body fat loss; and performed better on the 6-min walking test', 'mean walking distance']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C1268087', 'cui_str': 'Upper body structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0424630', 'cui_str': 'Loss of body fat - finding'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}]",,0.0271558,"In month 3, the AEPR group achieved a greater mean walking distance (p = 0.029) and O 2 saturation related to dyspnea (p = 0.001) than the AE group.","[{'ForeName': 'Gozde', 'Initials': 'G', 'LastName': 'In', 'Affiliation': 'School of Health Sciences, Bahçeşehir University, Istanbul, Turkey.'}, {'ForeName': 'Halit Eren', 'Initials': 'HE', 'LastName': 'Taskin', 'Affiliation': 'Cerrahpasa Medical Faculty, Department of Surgery, Istanbul University Cerrahpasa, Istanbul, Turkey. eren.taskin@istanbul.edu.tr.'}, {'ForeName': 'Muzaffer', 'Initials': 'M', 'LastName': 'Al', 'Affiliation': 'Faculty of Medicine, Department of Surgery, Near East University, Nicosia, Cyprus.'}, {'ForeName': 'Hasan Kerem', 'Initials': 'HK', 'LastName': 'Alptekin', 'Affiliation': 'School of Health Sciences, Bahçeşehir University, Istanbul, Turkey.'}, {'ForeName': 'Kagan', 'Initials': 'K', 'LastName': 'Zengin', 'Affiliation': 'Cerrahpasa Medical Faculty, Department of Surgery, Istanbul University Cerrahpasa, Istanbul, Turkey.'}, {'ForeName': 'Volkan', 'Initials': 'V', 'LastName': 'Yumuk', 'Affiliation': 'Cerrahpasa Medical Faculty, Department of Endocrinology and Metabolism, Istanbul University Cerrahpasa, Istanbul, Turkey.'}, {'ForeName': 'Baris', 'Initials': 'B', 'LastName': 'Ikitimur', 'Affiliation': 'Cerrahpasa Medical Faculty, Department of Cardiology, Istanbul University Cerrahpasa, Istanbul, Turkey.'}]",Obesity surgery,['10.1007/s11695-020-05144-5'] 1862,33408462,"Low-Dose Triple Antihypertensive Combination Therapy in Patients with Hypertension: A Randomized, Double-Blind, Phase II Study.","Purpose We evaluated the dose-responsiveness, efficacy, and safety of low-dose triple antihypertensive combination therapies in patients with mild-to-moderate hypertension. Patients and Methods After a 1 to 2-week placebo run-in period, 248 patients were randomized to the half-dose triple combination (amlodipine 2.5 mg + losartan 25 mg + chlorthalidone 6.25 mg), third-dose triple combination (amlodipine 1.67 mg + losartan 16.67 mg + chlorthalidone 4.17 mg), quarter-dose triple combination (amlodipine 1.25 mg + losartan 12.5 mg + chlorthalidone 3.13mg), amlodipine 10mg, amlodipine 5mg, losartan 100mg, and placebo groups for 8 weeks. The primary outcome was the mean change in systolic blood pressure (SBP) from baseline to week 8. Results The placebo-corrected SBP reductions of the half-dose, third-dose, quarter-dose combination, amlodipine 10 mg, amlodipine 5 mg and losartan 100 mg treatments were -17.2, -19.5, -14.9, -18.5, -11.3 and -9.9 mmHg, respectively. The BP control and response rates were significantly higher in the half-dose, third-dose, and quarter-dose combination groups than in the placebo group (all p < 0.01). Despite no intergroup differences in study drug-related adverse events, ankle circumference increased significantly in the amlodipine group compared to those in the combination treatment groups. The quarter-dose combination, amlodipine 5 mg, and losartan 100 mg groups showed similar SBP reduction and BP response rates. The SBP reduction and BP response rate in the third-dose and half-dose combination groups were not significantly different from those in the amlodipine 10 mg group but superior to those in the losartan 100 mg group. Conclusion Low-dose triple combination therapies could be effective as antihypertensive therapies. Trial Registration ClinicalTrials.gov identifier NCT03897868.",2020,"Despite no intergroup differences in study drug-related adverse events, ankle circumference increased significantly in the amlodipine group compared to those in the combination treatment groups.","['Patients with Hypertension', '248 patients', 'patients with mild-to-moderate hypertension']","['Low-Dose Triple Antihypertensive Combination Therapy', 'placebo', 'losartan', 'triple combination (amlodipine 2.5 mg + losartan 25 mg + chlorthalidone 6.25 mg), third-dose triple combination (amlodipine 1.67 mg + losartan 16.67 mg + chlorthalidone 4.17 mg), quarter-dose triple combination (amlodipine 1.25 mg + losartan 12.5 mg + chlorthalidone 3.13mg), amlodipine 10mg, amlodipine 5mg, losartan 100mg, and placebo', 'low-dose triple antihypertensive combination therapies', 'amlodipine']","['mean change in systolic blood pressure (SBP', 'SBP reduction and BP response rate', 'BP control and response rates', 'SBP reduction and BP response rates', 'adverse events, ankle circumference', 'SBP reductions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C1124795', 'cui_str': 'Amlodipine 2.5 MG'}, {'cui': 'C0008294', 'cui_str': 'Chlorthalidone'}, {'cui': 'C4517821', 'cui_str': '6.25'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C4517511', 'cui_str': '1.67'}, {'cui': 'C4517757', 'cui_str': '4.17'}, {'cui': 'C4517497', 'cui_str': '1.25'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C5191364', 'cui_str': '3.13'}, {'cui': 'C1124794', 'cui_str': 'Amlodipine 10 MG'}, {'cui': 'C1124796', 'cui_str': 'Amlodipine 5 MG'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}]",248.0,0.15907,"Despite no intergroup differences in study drug-related adverse events, ankle circumference increased significantly in the amlodipine group compared to those in the combination treatment groups.","[{'ForeName': 'Soon Jun', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ki-Chul', 'Initials': 'KC', 'LastName': 'Sung', 'Affiliation': 'Department of Cardiology, Gangbuk Samsung Hospital, Sungkyunkwan University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sang-Wook', 'Initials': 'SW', 'LastName': 'Lim', 'Affiliation': 'Cardiology Division, Cardiac Center, CHA Bundang Medical Center, CHA University, Seongnam, Republic of Korea.'}, {'ForeName': 'Seok-Yeon', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiology, Seoul Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Weon', 'Initials': 'W', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Kyung Hee University Medical Center, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Jinho', 'Initials': 'J', 'LastName': 'Shin', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sungha', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Cardiology, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hae-Young', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Department of Health Policy and Management, College of Health Science & Department of Health Care Science, Graduate School, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'Moo-Yong', 'Initials': 'MY', 'LastName': 'Rhee', 'Affiliation': 'Cardiovascular Center, Dongguk University Ilsan Hospital, Goyang-si, Gyeonggi, Republic of Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Drug design, development and therapy",['10.2147/DDDT.S286586'] 1863,33414239,"Use of proton pump inhibitors to treat persistent throat symptoms: multicentre, double blind, randomised, placebo controlled trial.","OBJECTIVE To assess the use of proton pump inhibitors (PPIs) to treat persistent throat symptoms. DESIGN Pragmatic, double blind, placebo controlled, randomised trial. SETTING Eight ear, nose, and throat outpatient clinics, United Kingdom. PARTICIPANTS 346 patients aged 18 years or older with persistent throat symptoms who were randomised according to recruiting centre and baseline severity of symptoms (mild or severe): 172 to lansoprazole and 174 to placebo. INTERVENTION Random blinded allocation (1:1) to either 30 mg lansoprazole twice daily or matched placebo twice daily for 16 weeks. MAIN OUTCOME MEASURES Primary outcome was symptomatic response at 16 weeks measured using the total reflux symptom index (RSI) score. Secondary outcomes included symptom response at 12 months, quality of life, and throat appearances. RESULTS Of 1427 patients initially screened for eligibility, 346 were recruited. The mean age of the study sample was 52.2 (SD 13.7) years, 196 (57%) were women, and 162 (47%) had severe symptoms at presentation; these characteristics were balanced across treatment arms. The primary analysis was performed on 220 patients who completed the primary outcome measure within a window of 14-20 weeks. Mean RSI scores were similar between treatment arms at baseline: lansoprazole 22.0 (95% confidence interval 20.4 to 23.6) and placebo 21.7 (20.5 to 23.0). Improvements (reduction in RSI score) were observed in both groups-score at 16 weeks: lansoprazole 17.4 (15.5 to19.4) and placebo 15.6 (13.8 to 17.3). No statistically significant difference was found between the treatment arms: estimated difference 1.9 points (95% confidence interval -0.3 to 4.2 points; P=0.096) adjusted for site and baseline symptom severity. Lansoprazole showed no benefits over placebo for any secondary outcome measure, including RSI scores at 12 months: lansoprazole 16.0 (13.6 to 18.4) and placebo 13.6 (11.7 to 15.5): estimated difference 2.4 points (-0.6 to 5.4 points). CONCLUSIONS No evidence was found of benefit from PPI treatment in patients with persistent throat symptoms. RSI scores were similar between the lansoprazole and placebo groups after 16 weeks of treatment and at the 12 month follow-up. TRIAL REGISTRATION ISRCTN Registry ISRCTN38578686 and EudraCT 2013-004249-17.",2021,Improvements (reduction in RSI score) were observed in both groups-score at 16 weeks: lansoprazole 17.4 (15.5 to19.4) and placebo 15.6 (13.8 to 17.3).,"['1427 patients initially screened for eligibility, 346 were recruited', 'patients with persistent throat symptoms', '346 patients aged 18 years or older with persistent throat symptoms who were randomised according to recruiting centre and baseline severity of symptoms (mild or severe): 172 to', 'Eight ear, nose, and throat outpatient clinics, United Kingdom', '220 patients who completed the primary outcome measure within a window of 14-20 weeks']","['lansoprazole twice daily or matched placebo', 'placebo', 'proton pump inhibitors', 'Lansoprazole', 'lansoprazole', 'proton pump inhibitors (PPIs']","['RSI scores', 'Mean RSI scores', 'severe symptoms', 'symptom response at 12 months, quality of life, and throat appearances', 'RSI score', 'total reflux symptom index (RSI) score', 'symptomatic response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0426484', 'cui_str': 'Throat symptom'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0050940', 'cui_str': 'lansoprazole'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0436345', 'cui_str': 'Symptom severe'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]",220.0,0.804871,Improvements (reduction in RSI score) were observed in both groups-score at 16 weeks: lansoprazole 17.4 (15.5 to19.4) and placebo 15.6 (13.8 to 17.3).,"[{'ForeName': 'James', 'Initials': 'J', 'LastName': ""O'Hara"", 'Affiliation': ""Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne NE7 7DN, UK James.O'Hara@newcastle.ac.uk.""}, {'ForeName': 'Deborah D', 'Initials': 'DD', 'LastName': 'Stocken', 'Affiliation': 'Clinical Trials Research, Leeds Institute of Clinical Trials Research University of Leeds, Leeds, UK.'}, {'ForeName': 'Gillian C', 'Initials': 'GC', 'LastName': 'Watson', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Fouweather', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'McGlashan', 'Affiliation': 'Nottingham University Hospitals, Nottingham, UK.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'MacKenzie', 'Affiliation': 'NHS Greater Glasgow and Clyde. Visiting Professor, University of Strathclyde, Glasgow, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Carding', 'Affiliation': 'Oxford Institute of Nursing, Midwifery and Allied Health Research, Oxford Brookes University, Oxford, UK.'}, {'ForeName': 'Yakubu', 'Initials': 'Y', 'LastName': 'Karagama', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Wood', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Janet A', 'Initials': 'JA', 'LastName': 'Wilson', 'Affiliation': 'Population Health Sciences Institute, Newcastle University and Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}]",BMJ (Clinical research ed.),['10.1136/bmj.m4903'] 1864,33412422,Symptom-network dynamics in irritable bowel syndrome with comorbid panic disorder using electronic momentary assessment: A randomized controlled trial of escitalopram vs. placebo.,"INTRODUCTION Momentary ecological assessment indicated alleviated abdominal pain in escitalopram treatment of irritable bowel syndrome (IBS) with comorbid panic disorder. Hitherto, little is known about symptom formation, i.e., how psychological impact physical symptoms, and vice versa, and about the effect of SSRI-treatment on symptom formation. OBJECTIVE To investigate how psychological and somatic symptoms co-vary over time in IBS patients with comorbid panic disorder and how they are affected by escitalopram treatment. METHODS Experience sampling data from 14 IBS patients with panic disorder were obtained from a single-centre, double-blind, parallel-group, randomized controlled trial on escitalopram versus placebo. At baseline, after three and six months, multilevel time-lagged linear regression analysis was used to construct symptom networks. Network connections represented coefficients between various affect and gastrointestinal items. RESULTS Connectivity increased up to 3 months in both groups. Between 3 and 6 months, connectivity decreased for placebo and further increased in the escitalopram group. Additionally, a steep increase in node strength for negative affect nodes was observed in the escitalopram network and the opposite for positive affect nodes. Over time, group symptom networks became increasingly different from each other. Anxious-anxious and enthusiastic-relaxed became significantly different between groups at 6 months. The connection that changed significantly in all analyses was anxious-anxious. CONCLUSIONS Escitalopram treatment was associated with changes in the symptom networks in IBS patients with panic disorder. While mood and physical symptoms improve over time, mainly connectivity between mood nodes changed, possibly pointing towards a healthier emotion regulation resulting in alleviation of physical symptoms.",2021,Anxious-anxious and enthusiastic-relaxed became significantly different between groups at 6 months.,"['14 IBS patients with panic disorder', 'irritable bowel syndrome (IBS) with comorbid panic disorder', 'IBS patients with comorbid panic disorder', 'IBS patients with panic disorder', 'irritable bowel syndrome with comorbid panic disorder using electronic momentary assessment']","['escitalopram vs. placebo', 'escitalopram versus placebo', 'placebo']","['Anxious-anxious and enthusiastic-relaxed', 'abdominal pain', 'symptom networks', 'connectivity', 'node strength', 'Connectivity']","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0558083', 'cui_str': 'Enthusiastic'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]",14.0,0.180393,Anxious-anxious and enthusiastic-relaxed became significantly different between groups at 6 months.,"[{'ForeName': 'Daniël', 'Initials': 'D', 'LastName': 'Kreiter', 'Affiliation': 'Faculty of Health, Medicine & Life Sciences, Maastricht University, Maastricht, the Netherlands. Electronic address: d.kreiter@alumni.maastrichtuniversity.nl.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Drukker', 'Affiliation': 'Department of Psychiatry and Psychology, School of Mental Health and Neuroscience (MHeNS), Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Zlatan', 'Initials': 'Z', 'LastName': 'Mujagic', 'Affiliation': 'Division of Gastroenterology-Hepatology, Department of Internal Medicine, Maastricht University Medical Centre, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht, the Netherlands.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Vork', 'Affiliation': 'Division of Gastroenterology-Hepatology, Department of Internal Medicine, Maastricht University Medical Centre, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht, the Netherlands.'}, {'ForeName': 'Bart P F', 'Initials': 'BPF', 'LastName': 'Rutten', 'Affiliation': 'Department of Psychiatry and Psychology, School of Mental Health and Neuroscience (MHeNS), Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'van Os', 'Affiliation': 'Department of Psychiatry and Psychology, School of Mental Health and Neuroscience (MHeNS), Maastricht University Medical Centre, Maastricht, the Netherlands; Department of Psychiatry, Brain Centre Rudolf Magnus, University Medical Centre Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Ad A M', 'Initials': 'AAM', 'LastName': 'Masclee', 'Affiliation': 'Division of Gastroenterology-Hepatology, Department of Internal Medicine, Maastricht University Medical Centre, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht, the Netherlands.'}, {'ForeName': 'Joanna W', 'Initials': 'JW', 'LastName': 'Kruimel', 'Affiliation': 'Division of Gastroenterology-Hepatology, Department of Internal Medicine, Maastricht University Medical Centre, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht, the Netherlands.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Leue', 'Affiliation': 'Department of Psychiatry and Psychology, School of Mental Health and Neuroscience (MHeNS), Maastricht University Medical Centre, Maastricht, the Netherlands. Electronic address: c.leue@mumc.nl.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110351'] 1865,33417035,Insights into the combination of neuromuscular electrical stimulation and motor imagery in a training-based approach.,"INTRODUCTION Training stimuli that partially activate the neuromuscular system, such as motor imagery (MI) or neuromuscular electrical stimulation (NMES), have been previously shown as efficient tools to induce strength gains. Here the efficacy of MI, NMES or NMES + MI trainings has been compared. METHODS Thirty-seven participants were enrolled in a training program of ten sessions in 2 weeks targeting plantar flexor muscles, distributed in four groups: MI, NMES, NMES + MI and control. Each group underwent forty contractions in each session, NMES + MI group doing 20 contractions of each modality. Before and after, the neuromuscular function was tested through the recording of maximal voluntary contraction (MVC), but also electrophysiological and mechanical responses associated with electrical nerve stimulation. Muscle architecture was assessed by ultrasonography. RESULTS MVC increased by 11.3 ± 3.5% in NMES group, by 13.8 ± 5.6% in MI, while unchanged for NMES + MI and control. During MVC, a significant increase in V-wave without associated changes in superimposed H-reflex has been observed for NMES and MI, suggesting that neural adaptations occurred at supraspinal level. Rest spinal excitability was increased in the MI group while decreased in the NMES group. No change in muscle architecture (pennation angle, fascicle length) has been found in any group but muscular peak twitch and soleus maximal M-wave increased in the NMES group only. CONCLUSION Finally, MI and NMES seem to be efficient stimuli to improve strength, although both exhibited different and specific neural plasticity. On its side, NMES + MI combination did not provide the expected gains, suggesting that their effects are not simply cumulative, or even are competitive.",2021,"No change in muscle architecture (pennation angle, fascicle length) has been found in any group but muscular peak twitch and soleus maximal M-wave increased in the NMES group only. ",['Thirty-seven participants were enrolled in a'],"['Training stimuli that partially activate the neuromuscular system, such as motor imagery (MI) or neuromuscular electrical stimulation (NMES', 'NMES\u2009+\u2009MI', 'neuromuscular electrical stimulation and motor imagery', 'training program of ten sessions in 2\xa0weeks targeting plantar flexor muscles, distributed in four groups: MI, NMES, NMES\u2009+\u2009MI and control', 'NMES']","['muscle architecture (pennation angle, fascicle length', 'muscular peak twitch and soleus maximal M-wave', 'MVC', 'Muscle architecture', 'Rest spinal excitability']","[{'cui': 'C4319569', 'cui_str': '37'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0242694', 'cui_str': 'Soleus muscle structure'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}]",37.0,0.0301398,"No change in muscle architecture (pennation angle, fascicle length) has been found in any group but muscular peak twitch and soleus maximal M-wave increased in the NMES group only. ","[{'ForeName': 'Amandine', 'Initials': 'A', 'LastName': 'Bouguetoch', 'Affiliation': 'Cognition, Action and Sensorimotor Plasticity [CAPS], Unité INSERM 1093, Université de Bourgogne-UFR STAPS, BP 27877, 21078, Dijon Cedex, France. amandine.bouguetoch@free.fr.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'Cognition, Action and Sensorimotor Plasticity [CAPS], Unité INSERM 1093, Université de Bourgogne-UFR STAPS, BP 27877, 21078, Dijon Cedex, France.'}, {'ForeName': 'Sidney', 'Initials': 'S', 'LastName': 'Grosprêtre', 'Affiliation': 'EA-4660 C3S Culture Sport Health Society, University of Bourgogne Franche-Comté, Besançon, France.'}]",European journal of applied physiology,['10.1007/s00421-020-04582-4'] 1866,33415649,"Rationale and Design of a Telehealth Self-Management, Shared Care Intervention for Post-treatment Survivors of Lung and Colorectal Cancer.","Survivors of lung and colorectal cancer have high post-treatment needs; the majority are older and suffer from greater comorbidities and poor quality of life (QOL). They remain underrepresented in research, leading to significant disparities in post-treatment outcomes. Personalized post-treatment follow-up care and care coordination among healthcare teams is a priority for survivors of lung and colorectal cancer. However, there are few evidence-based interventions that address survivors' post-treatment needs beyond the use of a follow-up care plan. This paper describes the rationale and design of an evidence-informed telehealth intervention that integrates shared care coordination between oncology/primary care and self-management skills building to empower post-treatment survivors of lung and colorectal cancer. The intervention design was informed by (1) contemporary published evidence on cancer survivorship, (2) our previous research in lung and colorectal cancer survivorship, (3) the chronic care self-management model (CCM), and (4) shared post-treatment follow-up care between oncology and primary care. A two-arm, parallel randomized controlled trial will determine the efficacy of the telehealth intervention to improve cancer care delivery and survivor-specific outcomes. ClinicalTrials.gov Identifier: NCT04428905.",2021,"A two-arm, parallel randomized controlled trial will determine the efficacy of the telehealth intervention to improve cancer care delivery and survivor-specific outcomes.","['Post-treatment Survivors of Lung and Colorectal Cancer', 'lung and colorectal cancer']","['Telehealth Self-Management, Shared Care Intervention', 'chronic care self-management model (CCM), and (4) shared post-treatment follow-up care between oncology and primary care', 'telehealth intervention']",[],"[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3899107', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]",[],,0.0294204,"A two-arm, parallel randomized controlled trial will determine the efficacy of the telehealth intervention to improve cancer care delivery and survivor-specific outcomes.","[{'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Sun', 'Affiliation': 'Department of Population Sciences, City of Hope, Duarte, CA, USA. vsun@coh.org.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Reb', 'Affiliation': 'Department of Population Sciences, City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Debay', 'Affiliation': 'Department of Family Medicine, University of California, Riverside, CA, USA.'}, {'ForeName': 'Marwan', 'Initials': 'M', 'LastName': 'Fakih', 'Affiliation': 'Department of Medical Oncology and Therapeutics Research, City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Ferrell', 'Affiliation': 'Department of Population Sciences, City of Hope, Duarte, CA, USA.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-021-01958-8'] 1867,33420673,"Effect of Fasting-Mimicking Diet or Continuous Energy Restriction on Weight Loss, Body Composition, and Appetite-Regulating Hormones Among Metabolically Healthy Women with Obesity: a Randomized Controlled, Parallel Trial.","BACKGROUND Fasting-mimicking diet (FMD) has been recently promoted to achieve similar metabolic changes of fasting. The purpose of our study was to compare the effect of FMD versus continuous energy restriction (CER) on anthropometric measurements, body composition, glucose metabolism, and serum levels of leptin, neuropeptide Y (NPY), and total ghrelin. METHODS A randomized controlled trial (RCT) was conducted on 60 women with obesity aged 18-55 years. Subjects received either a 5-day FMD (low in energy, sugars, and proteins, but high in unsaturated fats) or a CER (an average daily energy deficit of 500 kcal) for 2 months. Anthropometric and biochemical factors were measured at baseline and the end of the study. Serum levels of leptin, total ghrelin, and NPY were tested with an ELISA kit. Physical activity and dietary intakes were also recorded. RESULTS There was no significant difference in weight loss between the two groups: mean weight change for CER was - 2.29 (standard deviation [SD], 1.95) kg compared to - 1.13 (2.27) kg for FMD (p = 0.06). There was more reduction in the basal metabolic rate (BMR) in the CER group (p = 0.045). Favorable effects on fat mass and muscle mass were only seen in the FMD group. Although insulin resistance was reduced in the FMD group compared to the CER group, results were not significant after adjustment. After controlling for potential confounders, there was a significant increase in serum levels of total ghrelin (p = 0.048) and NPY (p = 0.041) following CER; however, results for circulating leptin were not statistically significant (p = 0.48). CONCLUSIONS There was no significant difference in weight loss following FMD and CER. However, FMD was more effective at reducing insulin resistance and regulating appetite-regulating hormones as well as preserving muscle mass and BMR. TRIAL REGISTRATION This trial was registered at the Iranian Clinical Trial Registry ( https://www.irct.ir/trial/40881 ) with the IRCT identification number IRCT20190717044244N1.",2021,There was more reduction in the basal metabolic rate (BMR) in the CER group (p = 0.045).,"['Metabolically Healthy Women with Obesity', '60 women with obesity aged 18-55\xa0years']","['Fasting-mimicking diet (FMD', '5-day FMD (low in energy, sugars, and proteins, but high in unsaturated fats) or a CER', 'Fasting-Mimicking Diet or Continuous Energy Restriction', 'FMD versus continuous energy restriction (CER']","['Weight Loss, Body Composition, and Appetite-Regulating Hormones', 'fat mass and muscle mass', 'weight loss', 'Serum levels of leptin, total ghrelin, and NPY', 'insulin resistance', 'serum levels of total ghrelin', 'insulin resistance and regulating appetite-regulating hormones', 'circulating leptin', 'Physical activity and dietary intakes', 'Anthropometric and biochemical factors', 'anthropometric measurements, body composition, glucose metabolism, and serum levels of leptin, neuropeptide Y (NPY), and total ghrelin', 'mean weight change for CER', 'basal metabolic rate (BMR']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015678', 'cui_str': 'Unsaturated fat'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0027893', 'cui_str': 'Neuropeptide Y'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0542499', 'cui_str': 'Measurement of basal metabolic rate'}, {'cui': 'C0678121', 'cui_str': 'Basal metabolic rate'}]",60.0,0.15117,There was more reduction in the basal metabolic rate (BMR) in the CER group (p = 0.045).,"[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Sadeghian', 'Affiliation': 'Student Research Committee, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Seyed Ahmad', 'Initials': 'SA', 'LastName': 'Hosseini', 'Affiliation': 'Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Zare Javid', 'Affiliation': 'Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. ahmaddjavid@gmail.com.'}, {'ForeName': 'Kambiz', 'Initials': 'K', 'LastName': 'Ahmadi Angali', 'Affiliation': 'Department of Biostatistics and Epidemiology, Faculty of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Mashkournia', 'Affiliation': 'Department of Internal Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",Obesity surgery,['10.1007/s11695-020-05202-y'] 1868,33418016,Efficacy and Safety of Paclitaxel-Coated Balloon Angioplasty for Dysfunctional Arteriovenous Fistulas: A Multicenter Randomized Controlled Trial.,"RATIONALE & OBJECTIVE Previous studies have illustrated the potential superiority of drug-coated balloons (DCBs) in maintaining patency after initial angioplasty for arteriovenous fistula (AVF) dysfunction due to stenosis. Our trial evaluated the efficacy and safety of DCBs for preventing fistula restenosis in Chinese hemodialysis patients. STUDY DESIGN Multicenter, prospective, randomized, open-label, blinded end point, controlled trial. SETTINGS & PARTICIPANTS A total of 161 hemodialysis patients with fistula dysfunction from 10 centers in China. INTERVENTION Participants were randomized 1:1 to treatment with initial dilation followed by DCB angioplasty or conventional high-pressure balloon (HPB) angioplasty. OUTCOMES The primary end point was target lesion primary patency defined as the target lesion intervention-free survival in conjunction with an ultrasonography-measured peak systolic velocity ratio (PSVR) ≤2.0 at 6 months. The secondary end points included 1) device, technical, clinical, and procedural success; 2) major adverse events; 3) degree of target lesion stenosis at 6 months; and 4) clinically driven target lesion and target shunt revascularization within 12 months. RESULTS The percentage with target lesion primary patency as defined by a PSVR ≤2.0 was higher in the DCB group than in the control group (65% vs 37%, respectively; rate difference, 28% [95% CI, 13%-43%]; P <0.001) at 6 months. The target lesion and target shunt intervention-free survival of the DCB group were not superior to those of the control group at 6 months (P = 0.3 and P = 0.2, respectively) but were superior at 12 months (target lesion intervention-free survival: 73% for DCB vs 58% for control [P = 0.04]; target shunt intervention-free survival: 73% for DCB vs 57% for control [P = 0.04]). The average degree of target lesion stenoses at 6 months was not significantly different between the 2 groups (44% ± 16% for DCB vs 49% ± 18% for control; P = 0.09). There were no significant differences in major adverse events or in device, technical, clinical, or procedural success rates between the groups. LIMITATIONS Small sample size; short follow-up period; procedural differences between the 2 groups such as unequal inflation times and balloon lengths. CONCLUSIONS Compared to conventional HPB angioplasty, DCB treatment achieved superior primary patency defined using PSVR measured at 6 months and superior intervention-free survival of both the target lesion and the target shunt at 12 months without evidence of greater adverse events. FUNDING Funded by ZhuHai Cardionovum Medical Device Co., Ltd. TRIAL REGISTRATION Registered at ClinicalTrials.gov with study number NCT02962141.",2021,"The target lesion and target shunt intervention-free survival of the DCB group were not superior to those of the control group at 6 months (P=0.3 and P= 0.2, respectively) but were superior at 12 months (target lesion, DCB 73% vs. control 58%, P=0.04; target shunt, DCB 73% vs. control 57%, P=0.04).","['161 hemodialysis patients with fistula dysfunction from 10 centers in China', 'Chinese hemodialysis patients', 'dysfunctional arteriovenous fistulas']","['initial dilation following DCB or only plain high-pressure balloon (HPB) angioplasty', 'conventional HPB angioplasty, DCB', 'drug-coated balloons (DCBs', 'DCBs', 'paclitaxel-coated balloon angioplasty']","['Average degree of target lesion stenoses', 'major adverse events or in device, technical, clinical, or procedural success rates', 'Efficacy and safety', 'target lesion primary patency, defined as target lesion intervention-free survival in conjunction with an ultrasound-measured peak systolic velocity ratio (PSVR', '1) device, technical, clinical, and procedural success; (2) major adverse events; (3) degree of target lesion stenosis at 6 months; and (4) clinically driven target lesion and target shunt revascularization', 'fistula restenosis', 'percentage with target lesion primary patency']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0000370', 'cui_str': ""3-3'dichlorobenzidine""}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0002996', 'cui_str': 'Balloon Angioplasty'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0542331', 'cui_str': 'Shunt'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",161.0,0.147825,"The target lesion and target shunt intervention-free survival of the DCB group were not superior to those of the control group at 6 months (P=0.3 and P= 0.2, respectively) but were superior at 12 months (target lesion, DCB 73% vs. control 58%, P=0.04; target shunt, DCB 73% vs. control 57%, P=0.04).","[{'ForeName': 'Yanqi', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': 'Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yaxue', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Vascular Surgery, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Tianlei', 'Initials': 'T', 'LastName': 'Cui', 'Affiliation': 'Department of Nephrology, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Nephrology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Jianghua', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Kidney Disease Center, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Nephrology Department, The First Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Zhengya', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Department of General and Vascular Surgery, Beijing Tongren Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Blood Purification Center, Hainan General Hospital, Haikou, Hainan, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Department of Nephrology, First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Wu', 'Affiliation': 'Blood Purification Center, The Third Xiangya Hospital of Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Qizhuang', 'Initials': 'Q', 'LastName': 'Jin', 'Affiliation': 'Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China. Electronic address: jinqizhuang@bjmu.edu.cn.'}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2020.11.022'] 1869,33417897,Effect of prophylactic clip application for the prevention of postpolypectomy bleeding of large pedunculated colonic polyps: a randomized controlled trial.,"BACKGROUND AND AIMS Prophylactic application of a hemoclip has been suggested as an alternative to the use of an endoloop for the prevention of postpolypectomy bleeding (PPB) when resecting large, pedunculated colorectal polyps. Therefore, this multicenter, randomized controlled trial investigated the efficacy of prophylactic hemoclip application to reduce PPB during the resection of large pedunculated polyps. METHODS Large pedunculated polyps (≥10 mm in head diameter) were eligible for inclusion. Polyps were randomized into a study arm (where clips were applied before resection) and a control arm (without pretreatment). The primary outcome was the rate of PPB in each group. PPB included immediate PPB (IPPB) and delayed PPB (DPPB). IPPB was defined as blood oozing (≥1 minute) or active spurting occurring immediately after polyp resection. DPPB was defined as rectal bleeding, occurring after completion of the colonoscopy. RESULTS In total, 238 polyps from 204 patients were randomized into the clip arm (119 polyps) or the control arm (119 polyps). Overall bleeding adverse events were observed in 20 cases (IPPB, 16; DPPB, 4). The rate of overall PPB, IPPB, and DPPB was 8.4%, 6.7%, and 1.7%, respectively, for all polyps. The rate of overall PPB (clip 4.2% vs control 12.6%, P = .033) and IPPB (clip 2.5% vs control 10.9%, P = .017) was significantly lower in the clip arm than the control arm. CONCLUSIONS Prophylactic clipping before resecting large pedunculated polyps can reduce overall PPB and IPPB compared with no prior treatment. Therefore, prophylactic clipping may be considered before resection of large pedunculated polyps. (Clinical trial registration number: NCT02156193.).",2021,"The rate of overall PPB (clip 4.2% vs control 12.6%, P=0.033) and IPPB (clip 2.5% vs control 10.9%, P=0.017) was significantly lower in the clip arm than the control arm. ","['postpolypectomy bleeding of large pedunculated colonic polyps', 'Large pedunculated polyps (≥10 mm in head diameter) were eligible for inclusion', 'In total, 238 polyps from 204 patients']","['prophylactic clip application', 'prophylactic hemoclip application', 'prophylactic clipping']","['IPPB', 'overall PPB and IPPB', 'rectal bleeding', 'Overall bleeding adverse events', 'rate of overall PPB, IPPB and DPPB', 'rate of PPB', 'DPPB', 'blood oozing (≥1 min) or active spurting', 'rate of overall PPB', 'PPB included immediate PPB (IPPB) and delayed PPB (DPPB']","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0009376', 'cui_str': 'Polyp of colon'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0032441', 'cui_str': 'Polybrominated biphenyl'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018932', 'cui_str': 'Hematochezia'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",238.0,0.187228,"The rate of overall PPB (clip 4.2% vs control 12.6%, P=0.033) and IPPB (clip 2.5% vs control 10.9%, P=0.017) was significantly lower in the clip arm than the control arm. ","[{'ForeName': 'Tae-Geun', 'Initials': 'TG', 'LastName': 'Gweon', 'Affiliation': ""Department of Internal Medicine, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea; Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Kang-Moon', 'Initials': 'KM', 'LastName': 'Lee', 'Affiliation': ""Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Seung-Woo', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': ""Department of Internal Medicine, Daejeon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Dae Bum', 'Initials': 'DB', 'LastName': 'Kim', 'Affiliation': ""Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Jeong-Seon', 'Initials': 'JS', 'LastName': 'Ji', 'Affiliation': ""Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Ji Min', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': ""Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Woo Chul', 'Initials': 'WC', 'LastName': 'Chung', 'Affiliation': ""Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Chang-Nyol', 'Initials': 'CN', 'LastName': 'Paik', 'Affiliation': ""Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Hwang', 'Initials': 'H', 'LastName': 'Choi', 'Affiliation': ""Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.12.040'] 1870,33421630,"Health-related quality of life, anxiety and depression up to 12 months post-stroke: Influence of sex, age, stroke severity and atrial fibrillation - A longitudinal subanalysis of the Find-AF RANDOMISED trial.","BACKGROUND Stroke can negatively impact the health-related quality of life (HRQoL). Anxiety or depression after stroke have been associated with poorer HRQoL, higher mortality and greater dependence in activities of daily living. We aimed to analyze HRQoL, anxiety and depressive symptoms in patients with and without atrial fibrillation (AF) up to 12 months post-stroke. METHODS Find-AF RANDOMISED was a prospective, randomized multicenter study, which included 398 patients ≥60 years with acute cerebral ischemia. HRQoL data were collected using the 3-level EuroQol-5D (EQ-5D-3L) and Stroke Impact Scale (SIS-16). Anxiety and depressive symptoms were measured using the Hospital Anxiety and Depression Scale (HADS). The severity of stroke was measured using the modified Rankin Scale (mRS). RESULTS In this study (mean age 72.7 ± 7.5 years, 40.2% females), there was a significant improvement in HRQoL using EQ-5D-3L after 3 months (β = 0.37, p < .01), 6 months (β = 0.43, p < .01) and 12 months (β = 0.44, p < .01) post-stroke compared to baseline. HADS anxiety scores after 3 months (β = -0.22, p < .01) and 12 months (β = -0.28, p < .01) were significantly reduced. Older patients reported reduced HRQoL and more depressive symptoms. Females indicated lower HRQoL and more anxiety. mRS score at baseline was an independent predictor for HRQoL. There was a significant but small effect of AF on EQ-5D-3L and on HADS anxiety. CONCLUSIONS Patients showed significant improvement in HRQoL and reduced anxiety after 3 and 12 months after stroke. We could demonstrate that the severity of stroke as well as sex and age impact long-term post-stroke HRQoL. CLINICAL TRIAL REGISTRATION Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01855035.",2021,"There was a significant but small effect of AF on EQ-5D-3L and on HADS anxiety. ","['patients with and without atrial fibrillation (AF) up to 12\xa0months post-stroke', '398 patients ≥60\xa0years with acute cerebral ischemia', 'Older patients']","['mRS', 'HRQoL']","['reduced HRQoL and more depressive symptoms', '3-level EuroQol-5D (EQ-5D-3L) and Stroke Impact Scale (SIS-16', 'Anxiety or depression', 'HRQoL and reduced anxiety', 'HRQoL, anxiety and depressive symptoms', 'modified Rankin Scale (mRS', 'HADS anxiety scores', 'lower HRQoL and more anxiety', 'Hospital Anxiety and Depression Scale (HADS', 'HRQoL using EQ-5D-3L', 'severity of stroke', 'stroke severity and atrial fibrillation ', 'Anxiety and depressive symptoms', 'Health-related quality of life, anxiety and depression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2215101', 'cui_str': 'Acute cerebral ischemia'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]",398.0,0.215771,"There was a significant but small effect of AF on EQ-5D-3L and on HADS anxiety. ","[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Sadlonova', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University of Göttingen Medical Center, Göttingen, Germany; Department of Thoracic- und Cardiovascular Surgery, University of Göttingen Medical Center, Göttingen, Germany; DZHK (German Center for Cardiovascular Research), Partner site Göttingen, Germany. Electronic address: monika.sadlonova@med.uni-goettingen.de.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Wasser', 'Affiliation': 'Department of Neurology, University of Göttingen Medical Center, Göttingen, Germany.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Nagel', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University of Göttingen Medical Center, Göttingen, Germany.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Weber-Krüger', 'Affiliation': 'Department of Cardiology and Pneumology, University of Göttingen Medical Center, Göttingen, Germany.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Gröschel', 'Affiliation': 'Department of Neurology, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Uphaus', 'Affiliation': 'Department of Neurology, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Liman', 'Affiliation': 'Department of Neurology, University of Göttingen Medical Center, Göttingen, Germany.'}, {'ForeName': 'Gerhard F', 'Initials': 'GF', 'LastName': 'Hamann', 'Affiliation': 'Department of Neurology and Neurorehabilitation, Bezirkskrankenhaus Günzburg, Günzburg, Germany.'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Kermer', 'Affiliation': 'Department of Neurology, University of Göttingen Medical Center, Göttingen, Germany; Department of Neurology, Nordwest-Krankenhaus Sanderbusch, Sande, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Gröschel', 'Affiliation': 'Department of Neurology, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Herrmann-Lingen', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University of Göttingen Medical Center, Göttingen, Germany; DZHK (German Center for Cardiovascular Research), Partner site Göttingen, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Wachter', 'Affiliation': 'DZHK (German Center for Cardiovascular Research), Partner site Göttingen, Germany; Department of Cardiology and Pneumology, University of Göttingen Medical Center, Göttingen, Germany; Department of Cardiology, University Hospital Leipzig, Leipzig, Germany.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110353'] 1871,33481787,"Benign ethnic neutropenia in a South African population, and its association with HIV acquisition and adverse event reporting in an HIV vaccine clinical trial.","Benign ethnic neutropenia (BEN) is defined as a neutrophil count of <1.5×109 cells/L in healthy individuals and is more common in populations of certain ethnicities, e.g. African or Middle Eastern ethnicity. Neutrophil values are commonly included in eligibility criteria for research participation, but little is known about the relationship between BEN, HIV acquisition, and the occurrence of adverse events during clinical trials. We investigated these relationships using data from an HIV vaccine efficacy trial of healthy adults from 5 South African sites. We analysed data from the double-blind, placebo-controlled, randomized trial HVTN 503, and its follow-on study HVTN 503-S to assess the prevalence of BEN, its association with HIV infection, and adverse event reporting. These data were then compared with a time- and age-matched, non-pregnant cohort from the National Health and Nutrition Examination Survey (NHANES) conducted between 2007-2008 in the United States (US). The 739 South African participants had a median age of 22.0 years (interquartile range = 20-26) and 56% (n = 412) were male. Amongst the US cohort of 845 participants, the median age was 26 (IQR: 21-30) and the majority (54%, 457/745) were also male. BEN was present at enrolment in 7.0% (n = 52) of South African participants (6% in the placebo group versus 8% in the vaccine group); 81% (n = 42) of those with BEN were male. Pretoria North had the highest prevalence of BEN (11.6%, 5/43), while Cape Town had the lowest (0.7%, 1/152). Participants with BEN had a lower median neutrophil count (1.3 vs. 3.2x109 cells/L; p<0.001) and BMI (20.8 vs. 22.3 kg/m2; p<0.001) when compared to those without BEN. A greater proportion of Black South Africans had neutrophil counts <1.5×109 cells/L compared to US non-Hispanic Whites from the NHANES cohort (7% [52/739] vs. 0.6% [3/540]; p<0.001). BEN did not increase the odds for HIV infection (adjusted odds ratio [aOR]: 1.364, 95% confidence interval [95% CI]: 0.625-2.976; p = 0.4351). However, female gender (aOR: 1.947, 95% CI: 1.265-2.996; p = 0.0025) and cannabis use (aOR: 2.192, 95% CI: 1.126-4.266; p = 0.0209) increased the odds of HIV acquisition. The incidence rates of adverse events were similar between participants in the placebo group with BEN, and those without: 12.1 (95% CI: 7.3-20.1) vs. 16.5 (95% CI: 14.6-18.7; p = 0.06) events per 100 person-years (py) were noted in the infections and infestations system organ class, respectively. The vaccine group had an event incidence rate of 19.7 (95% CI: 13.3-29.2) vs. 14.8 (95% CI: 13.0-16.8; p = 0.07) events per 100py in the group with, and without BEN, respectively. BEN is more prevalent in Black South Africans compared to US Non-Hispanic Whites. Our data do not support excluding populations from HIV vaccine trials because of BEN. BEN was not associated with increased risk for HIV infection or Adverse events on a vaccine trial. Predictors of HIV infection risk were females and cannabis use, underlying the continued importance of prevention programmes in focusing on these populations.",2021,Participants with BEN had a lower median neutrophil count (1.3 vs. 3.2x109 cells/L; p<0.001) and BMI (20.8 vs. 22.3 kg/m2; p<0.001) when compared to those without BEN.,"['845 participants, the median age was 26 (IQR: 21-30) and the majority (54%, 457/745) were also male', '739 South African participants had a median age of 22.0 years (interquartile range = 20-26) and 56% (n = 412) were male', 'healthy adults from 5 South African sites', 'non-pregnant cohort from the National Health and Nutrition Examination Survey (NHANES) conducted between 2007-2008 in the United States (US']","['BEN', 'placebo']","['incidence rates of adverse events', 'median neutrophil count', 'BMI', 'odds of HIV acquisition', 'odds for HIV infection', 'Neutrophil values', 'event incidence rate', 'neutrophil counts', 'BEN', 'risk for HIV infection or Adverse events']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0376344', 'cui_str': 'NHANES'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C3805116', 'cui_str': 'Benign ethnic neutropenia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C3805116', 'cui_str': 'Benign ethnic neutropenia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",412.0,0.482448,Participants with BEN had a lower median neutrophil count (1.3 vs. 3.2x109 cells/L; p<0.001) and BMI (20.8 vs. 22.3 kg/m2; p<0.001) when compared to those without BEN.,"[{'ForeName': 'Rephaim', 'Initials': 'R', 'LastName': 'Mpofu', 'Affiliation': 'Faculty of Health Sciences, Perinatal HIV Research Unit, University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Kennedy', 'Initials': 'K', 'LastName': 'Otwombe', 'Affiliation': 'Faculty of Health Sciences, Perinatal HIV Research Unit, University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Koleka', 'Initials': 'K', 'LastName': 'Mlisana', 'Affiliation': 'National Health Laboratory Service (NHLS), Cape Town, South Africa.'}, {'ForeName': 'Maphoshane', 'Initials': 'M', 'LastName': 'Nchabeleng', 'Affiliation': 'Mecru Clinical Research Unit, Sefako Makgatho Health Sciences University, Pretoria, South Africa.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Allen', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kublin', 'Affiliation': 'Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'M Juliana', 'Initials': 'MJ', 'LastName': 'McElrath', 'Affiliation': 'Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Churchyard', 'Affiliation': 'Aurum Institute, Johannesburg, South Africa.'}, {'ForeName': 'Glenda', 'Initials': 'G', 'LastName': 'Gray', 'Affiliation': 'Faculty of Health Sciences, Perinatal HIV Research Unit, University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Laher', 'Affiliation': 'Faculty of Health Sciences, Perinatal HIV Research Unit, University of Witwatersrand, Johannesburg, South Africa.'}]",PloS one,['10.1371/journal.pone.0241708'] 1872,33485703,"Spatial expression of metallothionein, matrix metalloproteinase-1 and Ki-67 in human epidermal wounds treated with zinc and determined by quantitative immunohistochemistry: A randomised double-blind trial.","Reepithelialisation is fundamental to wound healing, but our current understanding largely relies on cellular and animal studies. The aim of the present randomised double-blind three-arm controlled trial was to correlate genuine epidermal wound healing with key proteins and topical zinc treatment in humans. Sixty wounds were produced using deroofed suction blisters in 30 healthy volunteers and randomised to topical zinc sulphate (n = 20), placebo (n = 20), or control (n = 20) treatment for 4 days. All wounds with perilesional skin were processed for automatic immunostaining of paraffin tissue sections with monoclonal antibodies against Ki-67, metallothionein (MT) and matrix metalloproteinase (MMP)-1. Protein expression was quantified by automated digital image analysis. Epidermal Ki-67 and MT labelling indices were increased in keratinocytes in the neoepidermis (∼1.1 mm) and at the wound edge (0.5 mm) compared to normal skin. Increased MMP-1 immunostaining was restricted to the neoepidermis. MT was robustly upregulated in the upper dermis of the wounds. Zinc treatment enhanced MMP-1 expression beneath the neoepidermis via paracrine mechanisms and MT under the neoepidermis and in the nonepithelialised wound bed via direct actions of zinc as indicated by the induction of MT2A mRNA but not MMP-1 mRNA in cultured normal human dermal fibroblasts by zinc sulphate. The present human study demonstrates that quantitative immunohistochemistry can identify proteins involved in reepithelialisation and actions of external compounds. Increased dermal MT expression may contribute to the anti-inflammatory activities of zinc and increased MMP-1 levels to promote keratinocyte migration.",2021,Epidermal Ki-67 and MT labelling indices were increased in keratinocytes in the neoepidermis (∼1.1 mm) and at the wound edge (0.5 mm) compared to normal skin.,"['human epidermal wounds treated with zinc and determined by quantitative immunohistochemistry', '30 healthy volunteers', 'humans']","['topical zinc sulphate', 'placebo']","['Protein expression', 'Epidermal Ki-67 and MT labelling indices', 'MT']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0078794', 'cui_str': 'Zinc Sulfate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C0025545', 'cui_str': 'Metallothionein'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",60.0,0.190881,Epidermal Ki-67 and MT labelling indices were increased in keratinocytes in the neoepidermis (∼1.1 mm) and at the wound edge (0.5 mm) compared to normal skin.,"[{'ForeName': 'Magnus S', 'Initials': 'MS', 'LastName': 'Ågren', 'Affiliation': 'Department of Dermatology and Copenhagen Wound Healing Center, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark; Digestive Disease Center, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. Electronic address: magnusspagren@gmail.com.'}, {'ForeName': 'Lana', 'Initials': 'L', 'LastName': 'Chafranska', 'Affiliation': 'Department of Pathology, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Jens Ole', 'Initials': 'JO', 'LastName': 'Eriksen', 'Affiliation': 'Department of Pathology, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Julie Lyng', 'Initials': 'JL', 'LastName': 'Forman', 'Affiliation': 'Section of Biostatistics, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Morten J', 'Initials': 'MJ', 'LastName': 'Bjerrum', 'Affiliation': 'Department of Chemistry, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schjerling', 'Affiliation': 'Institute of Sports Medicine Copenhagen and Department of Biomedical Sciences, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Heidi F', 'Initials': 'HF', 'LastName': 'Larsen', 'Affiliation': 'Digestive Disease Center, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Cottarelli', 'Affiliation': 'Digestive Disease Center, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark; Department of Pharmaceutical Science, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Lars N', 'Initials': 'LN', 'LastName': 'Jorgensen', 'Affiliation': 'Digestive Disease Center, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lise Mette Rahbek', 'Initials': 'LMR', 'LastName': 'Gjerdrum', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Pathology, Zealand University Hospital, Roskilde, Denmark.'}]",European journal of cell biology,['10.1016/j.ejcb.2020.151147'] 1873,33432643,The effects of a psycho-educational intervention to improve pain management after day surgery: A randomised clinical trial.,"AIMS AND OBJECTIVES To evaluate the effectiveness of a psycho-educational intervention for shoulder and breast day surgery patients in decreasing pain intensity and pain interference with function and strengthening adherence with the analgesic regimen; and further to identify factors that influence average pain intensity and pain interference with function. BACKGROUND Pain is one of the most prevalent symptoms after day surgery. However, pain management is left to the patients and family, and interventions to help patients are needed. DESIGN Randomised clinical trial with an intervention (n = 101) and a usual care group (n = 119) using multiple measurements during 6 months postoperatively. The CONSORT checklist is used. METHODS Patients in the intervention group received a booklet about pain and pain management and coaching by research nurses on postoperative days 2, 3 and 7. Differences between groups were identified using the chi-squared analysis and t tests. Changes with time were identified using a linear mixed model with repeated measures. RESULTS After controlling for covariates, group differences at any time in average pain intensity and pain interference with function were not statistically significant. Changes over time within any one group in average pain intensity and pain interference with function were statistically significant and decreased with time. Higher levels of average pain intensity and pain interference over time were associated with shoulder surgery, female, younger, pain expectation, preoperative pain and poorer adherence. CONCLUSIONS No group differences related to the intervention were revealed, and preoperative teaching together with a pain management booklet and coaching may help to strengthen the intervention's effects. Further research on interventions directed towards pain management is needed. RELEVANCE TO CLINICAL PRACTICE Day surgery patients' postoperative pain and pain management is not satisfactorily handled. To encourage and educate patients to use the prescribed analgesics in the immediate postoperative days may be necessary to enhance pain management. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov (NCT01595035).",2021,Changes over time within any one group in average pain intensity and pain interference with function were statistically significant and decreased with time.,"['Day surgery patients', 'after day surgery', 'shoulder and breast day surgery patients', 'Patients in the intervention group received a']","['booklet about pain and pain management and coaching by research nurses', 'usual care group', 'psycho-educational intervention']","['average pain intensity and pain interference with function', 'postoperative pain and pain management', 'pain management', 'pain expectation, preoperative pain, and poorer adherence', 'average pain intensity and pain interference', 'pain intensity and pain interference with function and strengthening adherence']","[{'cui': 'C0282046', 'cui_str': 'Day Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0687693', 'cui_str': 'Research nurse'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.088519,Changes over time within any one group in average pain intensity and pain interference with function were statistically significant and decreased with time.,"[{'ForeName': 'Berit T', 'Initials': 'BT', 'LastName': 'Valeberg', 'Affiliation': 'Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Alfhild', 'Initials': 'A', 'LastName': 'Dihle', 'Affiliation': 'Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Milada C', 'Initials': 'MC', 'LastName': 'Småstuen', 'Affiliation': 'Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Anne O', 'Initials': 'AO', 'LastName': 'Endresen', 'Affiliation': 'Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Tone', 'Initials': 'T', 'LastName': 'Rustøen', 'Affiliation': 'Department of Nursing Science, Institute of Health and Society, Faculty of Medicine, University of Oslo, Oslo, Norway.'}]",Journal of clinical nursing,['10.1111/jocn.15659'] 1874,33428906,"Debunking myths about contraceptive safety among women in Kingston, Jamaica: Pilot randomized controlled trial.","OBJECTIVES (1) To create a short motion graphic video to debias women, using evidence from cognitive psychology, of 2 common myths about safety of intrauterine devices (IUDs) and implants in Jamaica; and (2) to conduct a pilot study to evaluate video effectiveness. STUDY DESIGN We conducted a series of 3 focus group discussions among target users to inform the development process of the script, story, character, and look of the intervention video. We randomized young, female nonusers of long-acting contraception at risk of pregnancy at a public clinic in Kingston in 2018-2019 to watch either the intervention (n = 113) or control video (n = 112). We used logistical regression to evaluate perceptions of method safety, naturalness, and uptake after 3 months of follow up. RESULTS Almost all (n = 220; 97.8%) participants completed the 3-month interview. More women in the intervention arm perceived IUDs to be safe (59.1%) compared to the control arm (43.6%; p = 0.02). Perceived implant safety increased from enrollment to follow up in the intervention and control arms (10.9 and 2.7 percentage-point increases, respectively); however, the difference between arms at follow up was not statistically significant (p = 0.57). This appeared to be due to arm imbalances at enrollment. Study arms did not differ at follow up in perceived IUD naturalness (p = 0.36) or implant naturalness (p = 0.68). CONCLUSIONS Findings from a pilot study of a video intervention suggest that using debiasing strategies from cognitive psychology has the potential to address misconceptions about contraceptive safety. A larger trial with adequate power is warranted. IMPLICATIONS Evidence from a pilot randomized controlled trial suggested that use of debiasing strategies from cognitive psychology could be effective in correcting women's misconceptions about contraception safety and thus show promise for the design of future contraceptive promotion videos to increase uptake.",2021,More women in the intervention arm perceived IUDs to be safe (59.1%) compared to the control arm (43.6%; p=0.02).,"['female non-users of long-acting contraception at risk of pregnancy at a public clinic in Kingston in 2018-2019 to watch either the intervention (n=113) or control video (n=112', 'women in Kingston, Jamaica']",[],"['perceived IUD naturalness', 'Perceived implant safety']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C3839721', 'cui_str': 'At risk of unplanned pregnancy'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0022337', 'cui_str': 'Jamaica'}]",[],"[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015927', 'cui_str': 'Fetal death'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.159394,More women in the intervention arm perceived IUDs to be safe (59.1%) compared to the control arm (43.6%; p=0.02).,"[{'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Hylton-Kong', 'Affiliation': 'Epidemiology Research and Training Unit (ERTU), Kingston, Jamaica; The University of the West Indies at Mona, Department of Community Health and Psychiatry, Mona, Jamaica.'}, {'ForeName': 'Markus J', 'Initials': 'MJ', 'LastName': 'Steiner', 'Affiliation': 'FHI 360, Product Development and Introduction Division, Durham, NC, United States.'}, {'ForeName': 'Althea', 'Initials': 'A', 'LastName': 'Bailey', 'Affiliation': 'The University of the West Indies at Mona, Department of Community Health and Psychiatry, Mona, Jamaica.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Palazzi', 'Affiliation': 'The Ohio State University (OSU), College of Arts and Sciences, Department of Design, Columbus, OH, United States.'}, {'ForeName': 'Maria F', 'Initials': 'MF', 'LastName': 'Gallo', 'Affiliation': 'OSU, College of Public Health, Division of Epidemiology, Columbus, OH, United States. Electronic address: gallo.86@osu.edu.'}]",Contraception,['10.1016/j.contraception.2020.12.016'] 1875,33428901,Extracorporeal life support in patients with acute myocardial infarction complicated by cardiogenic shock - Design and rationale of the ECLS-SHOCK trial.,"BACKGROUND In acute myocardial infarction complicated by cardiogenic shock the use of mechanical circulatory support devices remains controversial and data from randomized clinical trials are very limited. Extracorporeal life support (ECLS) - venoarterial extracorporeal membrane oxygenation - provides the strongest hemodynamic support in addition to oxygenation. However, despite increasing use it has not yet been properly investigated in randomized trials. Therefore, a prospective randomized adequately powered clinical trial is warranted. STUDY DESIGN The ECLS-SHOCK trial is a 420-patient controlled, international, multicenter, randomized, open-label trial. It is designed to compare whether treatment with ECLS in addition to early revascularization with percutaneous coronary intervention or alternatively coronary artery bypass grafting and optimal medical treatment is beneficial in comparison to no-ECLS in patients with severe infarct-related cardiogenic shock. Patients will be randomized in a 1:1 fashion to one of the two treatment arms. The primary efficacy endpoint of ECLS-SHOCK is 30-day mortality. Secondary outcome measures such as hemodynamic, laboratory, and clinical parameters will serve as surrogate endpoints for prognosis. Furthermore, a longer follow-up at 6 and 12 months will be performed including quality of life assessment. Safety endpoints include peripheral ischemic vascular complications, bleeding and stroke. CONCLUSIONS The ECLS-SHOCK trial will address essential questions of efficacy and safety of ECLS in addition to early revascularization in acute myocardial infarction complicated by cardiogenic shock.",2021,"The ECLS-SHOCK trial is a 420-patient controlled, international, multicenter, randomized, open-label trial.","['patients with acute myocardial infarction', 'patients with severe infarct-related cardiogenic shock']","['Extracorporeal life support', 'ECLS-SHOCK', 'Extracorporeal life support (ECLS) - venoarterial extracorporeal membrane oxygenation ', 'ECLS', 'percutaneous coronary intervention or alternatively coronary artery bypass grafting and optimal medical treatment']","['peripheral ischemic vascular complications, bleeding and stroke', 'quality of life assessment', 'hemodynamic, laboratory, and clinical parameters will serve as surrogate endpoints for prognosis', '30-day mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}]","[{'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C5192097', 'cui_str': 'Venoarterial extracorporeal membrane oxygenation'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0162488', 'cui_str': 'Surrogate Endpoint'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.238744,"The ECLS-SHOCK trial is a 420-patient controlled, international, multicenter, randomized, open-label trial.","[{'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany. Electronic address: holger.thiele@medizin.uni-leipzig.de.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Freund', 'Affiliation': 'Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Maria Rubini', 'Initials': 'MR', 'LastName': 'Gimenez', 'Affiliation': 'Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'de Waha-Thiele', 'Affiliation': 'University Heart Center Luebeck, Luebeck, Germany.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Akin', 'Affiliation': 'University Clinic Mannheim, Mannheim, Germany.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Pöss', 'Affiliation': 'Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Hans-Josef', 'Initials': 'HJ', 'LastName': 'Feistritzer', 'Affiliation': 'Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Fuernau', 'Affiliation': 'University Heart Center Luebeck, Luebeck, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Graf', 'Affiliation': 'University Heart Center Luebeck, Luebeck, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Nef', 'Affiliation': 'University Clinic Giessen, Giessen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'University Clinic Giessen, Giessen, Germany; Kerckhoff Clinic Bad Nauheim, Bad Nauheim, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'University Clinic Homburg, Homburg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Lauten', 'Affiliation': 'Helios Clinic Erfurt, Erfurt, Germany.'}, {'ForeName': 'P Christian', 'Initials': 'PC', 'LastName': 'Schulze', 'Affiliation': 'University Hospital Jena, Jena, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Voigt', 'Affiliation': 'Contilia Elisabeth-Krankenhaus, Essen, Germany, Essen, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nordbeck', 'Affiliation': 'University Clinic Würzburg, Würzburg, Germany.'}, {'ForeName': 'Stephan B', 'Initials': 'SB', 'LastName': 'Felix', 'Affiliation': 'Dept. of Internal Medicine B, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Abel', 'Affiliation': 'Dept. of Internal Medicine B, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Baldus', 'Affiliation': 'Heart Center Cologne, University Clinic Cologne, Cologne, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Laufs', 'Affiliation': 'University Clinic Leipzig, Leipzig, Germany.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Lenk', 'Affiliation': 'University Clinic Leipzig, Leipzig, Germany.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Landmesser', 'Affiliation': 'Charité, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Skurk', 'Affiliation': 'Charité, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Burkert', 'Initials': 'B', 'LastName': 'Pieske', 'Affiliation': 'Charité University Medicine, Campus Virchow Klinikum and German Heart Center and Berlin Brandenburger Center for Regenerative Therapies (BCRT) of the Berlin Institute of Health (BIH), Berlin, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Tschöpe', 'Affiliation': 'Charité University Medicine, Campus Virchow Klinikum and German Heart Center and Berlin Brandenburger Center for Regenerative Therapies (BCRT) of the Berlin Institute of Health (BIH), Berlin, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Hennersdorf', 'Affiliation': 'SLK-Clinic Heilbronn, Heilbronn, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Wengenmayer', 'Affiliation': 'University Heart Center Freiburg - Bad Krozingen, Freiburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Preusch', 'Affiliation': 'University Clinic Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Lars S', 'Initials': 'LS', 'LastName': 'Maier', 'Affiliation': 'University Clinic Regensburg, Regensburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jung', 'Affiliation': 'University Clinic Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Malte', 'Initials': 'M', 'LastName': 'Kelm', 'Affiliation': 'University Clinic Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Clemmensen', 'Affiliation': 'University Heart Center Hamburg, Hamburg, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Westermann', 'Affiliation': 'University Heart Center Hamburg, Hamburg, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Seidler', 'Affiliation': 'Heart Center Göttingen, University Medicine Göttingen, Göttingen, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Schieffer', 'Affiliation': 'University Clinic Marburg, Marburg, Germany.'}, {'ForeName': 'Tienush', 'Initials': 'T', 'LastName': 'Rassaf', 'Affiliation': 'Dept. of Cardiology and Vascular Medicine, West German Heart- and Vascular Center, University Hospital Essen, Germany.'}, {'ForeName': 'Amir-Abbas', 'Initials': 'AA', 'LastName': 'Mahabadi', 'Affiliation': 'Dept. of Cardiology and Vascular Medicine, West German Heart- and Vascular Center, University Hospital Essen, Germany.'}, {'ForeName': 'Mariuca', 'Initials': 'M', 'LastName': 'Vasa-Nicotera', 'Affiliation': 'University Clinic Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Meincke', 'Affiliation': 'Asklepios Clinic St. Georg, Hamburg, Germany.'}, {'ForeName': 'Melchior', 'Initials': 'M', 'LastName': 'Seyfarth', 'Affiliation': 'Heart Center Wuppertal; Witten-Herdecke University, Wuppertal, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kersten', 'Affiliation': 'University Clinic Aachen, Aachen, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Rottbauer', 'Affiliation': 'University Clinic Ulm, Ulm Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Boekstegers', 'Affiliation': 'Helios Clinic Siegburg, Siegburg, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Muellenbach', 'Affiliation': 'Klinikum Kassel, Kassel, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Dengler', 'Affiliation': 'SLK Clinic Bad Friedrichshall, Bad Friedrichshall, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kadel', 'Affiliation': 'Clinic Frankfurt Höchst, Frankfurt, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Schempf', 'Affiliation': 'Clinic Reutlingen, Reutlingen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Karagiannidis', 'Affiliation': 'ARDS and ECMO Center Cologne-Merheim, Cologne, Germany.'}, {'ForeName': 'Hans-Bernd', 'Initials': 'HB', 'LastName': 'Hopf', 'Affiliation': 'Asklepios Clinic Langen, Langen, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Lehmann', 'Affiliation': 'Asklepios Clinic Langen, Langen, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Bufe', 'Affiliation': 'Helios Clinic Krefeld, Krefeld, University Witten/Herdecke, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Baumanns', 'Affiliation': 'Kliniken Maria Hilf, Mönchengladbach, Germany.'}, {'ForeName': 'Alper', 'Initials': 'A', 'LastName': 'Öner', 'Affiliation': 'University Clinic Halle, Halle, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Linke', 'Affiliation': 'Heart Center Dresden - Technical University Dresden, Dresden, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Sedding', 'Affiliation': 'University Clinic Halle, Halle, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Ferrari', 'Affiliation': 'Helios Klinik HSK Wiesbaden, Wiesbaden, Germany.'}, {'ForeName': 'Leonhard', 'Initials': 'L', 'LastName': 'Bruch', 'Affiliation': 'Unfallkrankenhaus Berlin, Berlin, Germany.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Goldmann', 'Affiliation': 'Asklepios Clinic Hamburg-Harburg, Hamburg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'John', 'Affiliation': 'Paracelsius Private University, Clinic Nuremberg, Campus South, Nuremberg, Germany.'}, {'ForeName': 'Helge', 'Initials': 'H', 'LastName': 'Möllmann', 'Affiliation': 'St. Johannes Hospital Dortmund, Dortmund, Germany.'}, {'ForeName': 'Jutta', 'Initials': 'J', 'LastName': 'Franz', 'Affiliation': 'Clinic Winnenden, Winnenden, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Lapp', 'Affiliation': 'Zentralklinik Bad Berka, Bad Berka, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Lauten', 'Affiliation': 'Zentralklinik Bad Berka, Bad Berka, Germany.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Noc', 'Affiliation': 'University Medical Center Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Tomaz', 'Initials': 'T', 'LastName': 'Goslar', 'Affiliation': 'University Medical Center Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Ilka', 'Initials': 'I', 'LastName': 'Oerlecke', 'Affiliation': 'Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Taoufik', 'Initials': 'T', 'LastName': 'Ouarrak', 'Affiliation': 'Institut für Herzinfarktforschung, Ludwigshafen, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Schneider', 'Affiliation': 'Institut für Herzinfarktforschung, Ludwigshafen, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': 'Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Zeymer', 'Affiliation': 'Institut für Herzinfarktforschung, Ludwigshafen, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2021.01.002'] 1876,33411233,Attachment and Affect between Mothers with Depression and their Children: Longitudinal Outcomes of Child Parent Psychotherapy.,"The present investigation examined the longitudinal effects of Child-Parent Psychotherapy (CPP) for toddlers and their mothers with depression on: a) maternal affective expression, b) child affective expression, and c) mother-child cohesion. Mothers with depression (M age  = 31.7 years; 92.8% White, 3.5% Black, 2.1% Hispanic, 2.3% other) and their toddlers were randomized to receive CPP (DI; n = 66) or to a control group (DC; n = 64). Mothers without depression and their toddlers (NC; n = 68) were recruited as an additional comparison group. Dyads were assessed at baseline (T1; 20 months old), post-intervention (T2; 36 months old), and follow-up (T3; 9 years old). Data from a mother-child conflict task was coded as a measure of observed outcome variables. Change in post-intervention attachment security assessed via the Strange Situation was evaluated as a mediator between intervention condition and maternal and child affective expression and dyadic cohesion at T3. Change to secure attachment post-intervention significantly mediated the association between intervention condition and T3 maternal warmth and child anger/problem behavior. Toddlers of mothers with depression who received CPP showed higher rates of change to secure attachment compared to those in both the DC and NC groups. Dyads who changed to secure attachment at T2 displayed higher levels of maternal warmth at T3 and lower levels of child anger and problem behavior at T3. Implications for the use of CPP as a preventive intervention and the importance of attachment as a mediator of long-term outcomes are discussed.",2021,Change to secure attachment post-intervention significantly mediated the association between intervention condition and T3 maternal warmth and child anger/problem behavior.,"['Mothers without depression and their toddlers (NC; n\u2009=\u200968', 'Mothers with depression (M age \u2009=\u200931.7\xa0years; 92.8% White, 3.5% Black, 2.1% Hispanic, 2.3% other) and their toddlers', 'toddlers and their mothers with depression on: a) maternal affective expression, b) child affective expression, and c) mother-child cohesion', 'Toddlers of mothers with depression who received', 'Mothers with Depression and their Children']","['Child Parent Psychotherapy', 'Child-Parent Psychotherapy (CPP', 'CPP']","['maternal warmth at T3 and lower levels of child anger and problem behavior', 'T3 maternal warmth and child anger/problem behavior', 'rates of change to secure attachment']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4708784', 'cui_str': '31.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0047123', 'cui_str': '3-(2-carboxypiperazin-4-yl)propyl-1-phosphonic acid'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0582757', 'cui_str': 'Secure attachment'}]",68.0,0.0227988,Change to secure attachment post-intervention significantly mediated the association between intervention condition and T3 maternal warmth and child anger/problem behavior.,"[{'ForeName': 'Danielle J', 'Initials': 'DJ', 'LastName': 'Guild', 'Affiliation': 'Mt. Hope Family Center, University of Rochester, 187 Edinburgh Street, Rochester, NY, 14608, USA.'}, {'ForeName': 'Michelle E', 'Initials': 'ME', 'LastName': 'Alto', 'Affiliation': 'Mt. Hope Family Center, University of Rochester, 187 Edinburgh Street, Rochester, NY, 14608, USA.'}, {'ForeName': 'Elizabeth D', 'Initials': 'ED', 'LastName': 'Handley', 'Affiliation': 'Mt. Hope Family Center, University of Rochester, 187 Edinburgh Street, Rochester, NY, 14608, USA.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Rogosch', 'Affiliation': 'Mt. Hope Family Center, University of Rochester, 187 Edinburgh Street, Rochester, NY, 14608, USA.'}, {'ForeName': 'Dante', 'Initials': 'D', 'LastName': 'Cicchetti', 'Affiliation': 'Mt. Hope Family Center, University of Rochester, 187 Edinburgh Street, Rochester, NY, 14608, USA.'}, {'ForeName': 'Sheree L', 'Initials': 'SL', 'LastName': 'Toth', 'Affiliation': 'Mt. Hope Family Center, University of Rochester, 187 Edinburgh Street, Rochester, NY, 14608, USA. sheree_toth@urmc.rochester.edu.'}]",Research on child and adolescent psychopathology,['10.1007/s10802-020-00681-0'] 1877,33412570,Evaluating the effect of an educational intervention on the adherence rate to sleep study: A multi-centered stratified randomized controlled trial.,"An appropriate diagnosis and effective treatment of sleep apnea can improve the associated quality of care and reduce morbidities. The study aims to develop and evaluate an educational intervention tailored to patients' needs in order to increase the rate of patients' adherence to physician's prescription for a sleep test. A multi-center, stratified, 2 parallel-arm, randomized controlled trial was conducted. The patients in the intervention group received the educational booklets on sleep apnea and sleep test which was designed based on the extracted factors through an in-depth interview with patients. All participants were contacted after two months to ask whether they completed an assessment for OSA. A total number of 1,650 individuals were screened. Finally, 104 participants were randomized to the control group (n = 50) or intervention group (n = 45) that did not differ significantly in baseline characteristics. The results of the intention to treat analysis indicate that patients in the intervention group were significantly more adherent to attend a sleep assessment for their OSA risk (30%; n = 15/50) than the patients in the control group (11.1%; n = 5/45, P <0.05). Age, history of diabetes, and the educational intervention were effective in performing the sleep test. Time limitations, Condition improvement, and high cost of diagnostic test were the most barriers, respectively. The intervention was successful in improving the adherence rate of patients to prescribed sleep test. However, the adherence rate to sleep study testing is still far from desirable and requires more complex interventions.",2021,"The results of the intention to treat analysis indicate that patients in the intervention group were significantly more adherent to attend a sleep assessment for their OSA risk (30%; n = 15/50) than the patients in the control group (11.1%; n = 5/45, P <0.05).","['A total number of 1,650 individuals were screened', '104 participants']","['educational booklets', 'educational intervention']","['sleep apnea and sleep test', 'adherence rate of patients to prescribed sleep test', 'Time limitations, Condition improvement, and high cost of diagnostic test', 'adherent to attend a sleep assessment for their OSA risk', 'adherence rate']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517527', 'cui_str': '104'}]","[{'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0430022', 'cui_str': 'Diagnostic procedure'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",104.0,0.058034,"The results of the intention to treat analysis indicate that patients in the intervention group were significantly more adherent to attend a sleep assessment for their OSA risk (30%; n = 15/50) than the patients in the control group (11.1%; n = 5/45, P <0.05).","[{'ForeName': 'Shokoufeh', 'Initials': 'S', 'LastName': 'Aalaei', 'Affiliation': 'Department of Medical Informatics, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Amini', 'Affiliation': 'Lung Diseases Research Center, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Fariborz', 'Initials': 'F', 'LastName': 'Rezaeitalab', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Asadpour', 'Affiliation': 'Sleep Laboratory of Ibn-e-Sina Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Tabesh', 'Affiliation': 'Department of Medical Informatics, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Farnaz', 'Initials': 'F', 'LastName': 'Khoshrounejad', 'Affiliation': 'Department of Medical Informatics, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Eslami', 'Affiliation': 'Department of Medical Informatics, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Lahya', 'Initials': 'L', 'LastName': 'Afshari Saleh', 'Affiliation': 'Department of Occupational Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",PloS one,['10.1371/journal.pone.0244496'] 1878,33412562,Personalized treatments for depressive symptoms in patients with advanced heart failure: A pragmatic randomized controlled trial.,"OBJECTIVES Heart Failure is a chronic syndrome affecting over 5.7 million in the US and 26 million adults worldwide with nearly 50% experiencing depressive symptoms. The objective of the study is to compare the effects of two evidence-based treatment options for adult patients with depression and advanced heart failure, on depressive symptom severity, physical and mental health related quality of life (HRQoL), heart-failure specific quality of life, caregiver burden, morbidity, and mortality at 3, 6 and 12-months. METHODS Trial design. Pragmatic, randomized, comparative effectiveness trial. Interventions. The treatment interventions are: (1) Behavioral Activation (BA), a patient-centered psychotherapy which emphasizes engagement in enjoyable and valued personalized activities as selected by the patient; or (2) Antidepressant Medication Management administered using the collaborative care model (MEDS). Participants. Adults aged 18 and over with advanced heart failure (defined as New York Heart Association (NYHA) Class II, III, and IV) and depression (defined as a score of 10 or above on the PHQ-9 and confirmed by the MINI International Neuropsychiatric Interview for the DSM-5) selected from all patients at Cedars-Sinai Medical Center who are admitted with heart failure and all patients presenting to the outpatient programs of the Smidt Heart Institute at Cedars-Sinai Medical Center. We plan to randomize 416 patients to BA or MEDS, with an estimated 28% loss to follow-up/inability to collect follow-up data. Thus, we plan to include 150 in each group for a total of 300 participants from which data after randomization will be collected and analyzed. CONCLUSIONS The current trial is the first to compare the impact of BA and MEDS on depressive symptoms, quality of life, caregiver burden, morbidity, and mortality in patients with depression and advanced heart failure. The trial will provide novel results that will be disseminated and implemented into a wide range of current practice settings. REGISTRATION ClinicalTrials.Gov Identifier: NCT03688100.",2021,"The current trial is the first to compare the impact of BA and MEDS on depressive symptoms, quality of life, caregiver burden, morbidity, and mortality in patients with depression and advanced heart failure.","['patients with depression and advanced heart failure', '150 in each group for a total of 300 participants from which data after randomization will be collected and analyzed', 'patients at Cedars-Sinai Medical Center who are admitted with heart failure and all patients presenting to the outpatient programs of the Smidt Heart Institute at Cedars-Sinai Medical Center', '416 patients to BA or MEDS, with an estimated 28% loss to follow-up/inability to collect follow-up data', 'adult patients with depression and advanced heart failure, on depressive symptom severity, physical and mental health related', 'chronic syndrome affecting over 5.7 million in the US and 26 million adults worldwide with nearly 50% experiencing depressive symptoms', 'patients with advanced heart failure', 'Adults aged 18 and over with advanced heart failure (defined as New York Heart Association (NYHA']","['Behavioral Activation (BA), a patient-centered psychotherapy which emphasizes engagement in enjoyable and valued personalized activities as selected by the patient; or (2) Antidepressant Medication Management administered using the collaborative care model (MEDS', 'BA and MEDS', 'Personalized treatments']","['quality of life (HRQoL), heart-failure specific quality of life, caregiver burden, morbidity, and mortality', 'depressive symptoms', 'depressive symptoms, quality of life, caregiver burden, morbidity, and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",300.0,0.111783,"The current trial is the first to compare the impact of BA and MEDS on depressive symptoms, quality of life, caregiver burden, morbidity, and mortality in patients with depression and advanced heart failure.","[{'ForeName': 'Waguih William', 'Initials': 'WW', 'LastName': 'IsHak', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, Cedars-Sinai Medical Center, Los Angeles, CA, United States of America.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Korouri', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, Cedars-Sinai Medical Center, Los Angeles, CA, United States of America.'}, {'ForeName': 'Tarneem', 'Initials': 'T', 'LastName': 'Darwish', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, Cedars-Sinai Medical Center, Los Angeles, CA, United States of America.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Vanle', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, Cedars-Sinai Medical Center, Los Angeles, CA, United States of America.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Dang', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, Cedars-Sinai Medical Center, Los Angeles, CA, United States of America.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Edwards', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, Cedars-Sinai Medical Center, Los Angeles, CA, United States of America.'}, {'ForeName': 'Jeanne T', 'Initials': 'JT', 'LastName': 'Black', 'Affiliation': 'Division of Health Services Research, Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA, United States of America.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Aronow', 'Affiliation': 'Division of Health Services Research, Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA, United States of America.'}, {'ForeName': 'Asher', 'Initials': 'A', 'LastName': 'Kimchi', 'Affiliation': 'Cedars-Sinai Smidt Heart Institute, Los Angeles, CA, United States of America.'}, {'ForeName': 'Brennan', 'Initials': 'B', 'LastName': 'Spiegel', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, CA, United States of America.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Hedrick', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, Cedars-Sinai Medical Center, Los Angeles, CA, United States of America.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Chernoff', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, Cedars-Sinai Medical Center, Los Angeles, CA, United States of America.'}, {'ForeName': 'Marcio A', 'Initials': 'MA', 'LastName': 'Diniz', 'Affiliation': 'Biostatistics Research Center, Cedars-Sinai Medical Center, Los Angeles, CA, United States of America.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Mirocha', 'Affiliation': 'Biostatistics Research Center, Cedars-Sinai Medical Center, Los Angeles, CA, United States of America.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Manoukian', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, Cedars-Sinai Medical Center, Los Angeles, CA, United States of America.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Harold', 'Affiliation': 'Cedars-Sinai Smidt Heart Institute, Los Angeles, CA, United States of America.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Ong', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, CA, United States of America.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Wells', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, CA, United States of America.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Hamilton', 'Affiliation': 'Cedars-Sinai Smidt Heart Institute, Los Angeles, CA, United States of America.'}, {'ForeName': 'Itai', 'Initials': 'I', 'LastName': 'Danovitch', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, Cedars-Sinai Medical Center, Los Angeles, CA, United States of America.'}]",PloS one,['10.1371/journal.pone.0244453'] 1879,33416294,"Maternal and Perinatal Outcomes of Expectant Management of Full-Term, Low-Risk, Nulliparous Patients.","OBJECTIVE To compare risks of maternal and perinatal outcomes by completed week of gestation from 39 weeks in low-risk nulliparous patients undergoing expectant management. METHODS We conducted a secondary analysis of a multicenter randomized trial of elective induction of labor at 39 weeks of gestation compared with expectant management in low-risk nulliparous patients. Participants with nonanomalous neonates, who were randomized to and underwent expectant management and attained 39 0/7 weeks of gestation, were included. Delivery gestation was categorized by completed week: 39 0/7-39 6/7 (39 weeks), 40 0/7-40 6/7 (40 weeks), and 41 0/7-42 2/7 (41-42 weeks) (none delivered after 42 2/7). The coprimary outcomes were cesarean delivery and a perinatal composite (death, respiratory support, 5-minute Apgar score 3 or less, hypoxic ischemic encephalopathy, seizure, sepsis, meconium aspiration syndrome, birth trauma, intracranial or subgaleal hemorrhage, or hypotension requiring vasopressor support). Other outcomes included a maternal composite (blood transfusion, surgical intervention for postpartum hemorrhage, or intensive care unit admission), hypertensive disorders of pregnancy, peripartum infection, and neonatal intermediate or intensive care unit admission. For multivariable analysis, P<.0125 was considered to indicate statistical significance for the coprimary outcomes. RESULTS Of 2,502 participants who underwent expectant management, 964 (38.5%) delivered at 39 weeks of gestation, 1,111 (44.4%) at 40 weeks, and 427 (17.1%) at 41-42 weeks. The prevalence of medically indicated delivery was 37.9% overall and increased from 23.8% at 39 weeks of gestation to 80.3% at 41-42 weeks. The frequency of cesarean delivery (17.3%, 22.0%, 37.5%; P<.001) and the perinatal composite (5.1%, 5.9%, 8.2%; P=.03) increased with 39, 40, and 41-42 weeks of gestation, respectively, and hypertensive disorders of pregnancy decreased (16.4%, 12.1%, 10.8%, P=.001). The adjusted relative risk, 95% CI (39 weeks as referent) was significant for cesarean delivery at 41-42 weeks of gestation (1.93, 1.61-2.32) and for hypertensive disorders of pregnancy at 40 weeks (0.71, 0.58-0.88) and 41-42 weeks (0.61, 0.45-0.82). None of the other outcomes were significant. CONCLUSION In expectantly managed low-risk nulliparous participants, the frequency of medically indicated induction of labor, and the risks of cesarean delivery but not the perinatal composite outcome, increased significantly from 39 to 42 weeks of gestation.",2021,"The frequency of cesarean delivery (17.3%, 22.0%, 37.5%; P<.001) and the perinatal composite (5.1%, 5.9%, 8.2%; P=.03) increased with 39, 40, and 41-42 weeks of gestation, respectively, and hypertensive disorders of pregnancy decreased (16.4%, 12.1%, 10.8%, P=.001).","['low-risk nulliparous patients undergoing expectant management', 'Nulliparous Patients', 'low-risk nulliparous patients', 'Participants with nonanomalous neonates']","['elective induction of labor', 'expectant management']","['maternal composite (blood transfusion, surgical intervention for postpartum hemorrhage, or intensive care unit admission), hypertensive disorders of pregnancy, peripartum infection, and neonatal intermediate or intensive care unit admission', 'frequency of cesarean delivery', 'cesarean delivery and a perinatal composite (death, respiratory support, 5-minute Apgar score 3 or less, hypoxic ischemic encephalopathy, seizure, sepsis, meconium aspiration syndrome, birth trauma, intracranial or subgaleal hemorrhage, or hypotension requiring vasopressor support', 'hypertensive disorders of pregnancy', 'cesarean delivery', 'Delivery gestation', 'frequency of medically indicated induction of labor, and the risks of cesarean delivery', 'perinatal composite']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C2936491', 'cui_str': 'Peripartum period'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0233245', 'cui_str': 'Apgar score 3'}, {'cui': 'C0752304', 'cui_str': 'Hypoxic ischemic encephalopathy'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0025048', 'cui_str': 'Meconium aspiration syndrome'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0475728', 'cui_str': 'Subgaleal hemorrhage'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",2502.0,0.22139,"The frequency of cesarean delivery (17.3%, 22.0%, 37.5%; P<.001) and the perinatal composite (5.1%, 5.9%, 8.2%; P=.03) increased with 39, 40, and 41-42 weeks of gestation, respectively, and hypertensive disorders of pregnancy decreased (16.4%, 12.1%, 10.8%, P=.001).","[{'ForeName': 'Alan T N', 'Initials': 'ATN', 'LastName': 'Tita', 'Affiliation': ""Departments of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama, Northwestern University, Chicago, Illinois, University of Utah Health Sciences Center, Salt Lake City, Utah, Stanford University, Stanford, California, Columbia University, New York, New York, Brown University, Providence, Rhode Island, University of Texas Medical Branch, Galveston, Texas, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas, The Ohio State University, Columbus, Ohio, Metro Health Medical Center-Case Western Reserve University, Cleveland, Ohio, University of Texas Southwestern Medical Center, Dallas, Texas; University of Pennsylvania, Philadelphia, Pennsylvania, Duke University, Durham, North Carolina, University of Pittsburgh, Pittsburgh, Pennsylvania, Washington University in St. Louis, St. Louis, Missouri; the George Washington University Biostatistics Center, Washington, DC; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.""}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Doherty', 'Affiliation': ''}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Grobman', 'Affiliation': ''}, {'ForeName': 'Uma M', 'Initials': 'UM', 'LastName': 'Reddy', 'Affiliation': ''}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': ''}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Mallett', 'Affiliation': ''}, {'ForeName': 'Madeline Murguia', 'Initials': 'MM', 'LastName': 'Rice', 'Affiliation': ''}, {'ForeName': 'Yasser Y', 'Initials': 'YY', 'LastName': 'El-Sayed', 'Affiliation': ''}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Wapner', 'Affiliation': ''}, {'ForeName': 'Dwight J', 'Initials': 'DJ', 'LastName': 'Rouse', 'Affiliation': ''}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Saade', 'Affiliation': ''}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Thorp', 'Affiliation': ''}, {'ForeName': 'Suneet P', 'Initials': 'SP', 'LastName': 'Chauhan', 'Affiliation': ''}, {'ForeName': 'Maged M', 'Initials': 'MM', 'LastName': 'Costantine', 'Affiliation': ''}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Chien', 'Affiliation': ''}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Casey', 'Affiliation': ''}, {'ForeName': 'Sindhu K', 'Initials': 'SK', 'LastName': 'Srinivas', 'Affiliation': ''}, {'ForeName': 'Geeta K', 'Initials': 'GK', 'LastName': 'Swamy', 'Affiliation': ''}, {'ForeName': 'Hyagriv N', 'Initials': 'HN', 'LastName': 'Simhan', 'Affiliation': ''}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Macones', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004230'] 1880,33416292,Prophylactic Negative Pressure Wound Therapy After Laparotomy for Gynecologic Surgery: A Randomized Controlled Trial.,"OBJECTIVE To estimate the effectiveness of prophylactic negative pressure wound therapy in patients undergoing laparotomy for gynecologic surgery. METHODS We conducted a randomized controlled trial. Eligible, consenting patients, regardless of body mass index (BMI), who were undergoing laparotomy for presumed gynecologic malignancy were randomly allocated to standard gauze or negative pressure wound therapy. Patients with BMIs of 40 or greater and benign disease also were eligible. Randomization, stratified by BMI, occurred after skin closure. The primary outcome was wound complication within 30 (±5) days of surgery. A sample size of 343 per group (N=686) was planned. RESULTS From March 1, 2016, to August 20, 2019, we identified 663 potential patients; 289 were randomized to negative pressure wound therapy (254 evaluable participants) and 294 to standard gauze (251 evaluable participants), for a total of 505 evaluable patients. The median age of the entire cohort was 61 years (range 20-87). Four hundred ninety-five patients (98%) underwent laparotomy for malignancy. The trial was eventually stopped for futility after an interim analysis of 444 patients. The rate of wound complications was 17.3% in the negative pressure wound therapy (NPWT) group and 16.3% in the gauze group, absolute risk difference 1% (90% CI -4.5 to 6.5%; P=.77). Adjusted odds ratio controlling for estimated blood loss and diabetes was 0.99 (90% CI 0.62-1.60). Skin blistering occurred in 33 patients (13%) in the NPWT group and in three patients (1.2%) in the gauze group (P<.001). CONCLUSION Negative pressure wound therapy after laparotomy for gynecologic surgery did not lower the wound complication rate but did increase skin blistering. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, NCT02682316. FUNDING SOURCE The protocol was supported in part by KCI/Acelity.",2021,"The rate of wound complications was 17.3% in the negative pressure wound therapy (NPWT) group and 16.3% in the gauze group, absolute risk difference 1% (90% CI -4.5 to 6.5%; P=.77).","['444 patients', '254 evaluable participants) and 294 to standard gauze (251 evaluable participants), for a total of 505 evaluable patients', 'Gynecologic Surgery', 'From March 1, 2016, to August 20, 2019, we identified 663 potential patients; 289', 'Patients with BMIs of 40 or greater and benign disease also were eligible', 'patients undergoing laparotomy for gynecologic surgery', 'Four hundred ninety-five patients (98%) underwent laparotomy for malignancy', 'Eligible, consenting patients, regardless of body mass index (BMI), who were undergoing laparotomy for presumed gynecologic malignancy']","['prophylactic negative pressure wound therapy', 'negative pressure wound therapy', 'negative pressure wound therapy (NPWT', 'standard gauze or negative pressure wound therapy', 'Prophylactic Negative Pressure Wound Therapy']","['Skin blistering', 'wound complication within 30 (±5) days of surgery', 'wound complication rate', 'skin blistering', 'rate of wound complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0590323', 'cui_str': 'Gauzes'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0590323', 'cui_str': 'Gauzes'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0005758', 'cui_str': 'Blister'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",505.0,0.232933,"The rate of wound complications was 17.3% in the negative pressure wound therapy (NPWT) group and 16.3% in the gauze group, absolute risk difference 1% (90% CI -4.5 to 6.5%; P=.77).","[{'ForeName': 'Mario M', 'Initials': 'MM', 'LastName': 'Leitao', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, the Department of Obstetrics and Gynecology, Weill Cornell Medical College, and the Department of Biostatistics and Epidemiology, Memorial Sloan Kettering Cancer Center, New York, New York; the Division of Gynecologic Oncology, Hartford Healthcare Cancer Institute, Hartford, Connecticut; the Lehigh Valley Cancer Institute, Allentown, Pennsylvania; and the Miami Cancer Institute, Miami, Florida.'}, {'ForeName': 'Qin C', 'Initials': 'QC', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Maria B', 'Initials': 'MB', 'LastName': 'Schiavone', 'Affiliation': ''}, {'ForeName': 'Renee A', 'Initials': 'RA', 'LastName': 'Cowan', 'Affiliation': ''}, {'ForeName': 'Evan S', 'Initials': 'ES', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Iasonos', 'Affiliation': ''}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Veith', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rafizadeh', 'Affiliation': ''}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Curran', 'Affiliation': ''}, {'ForeName': 'Bhavani', 'Initials': 'B', 'LastName': 'Ramesh', 'Affiliation': ''}, {'ForeName': 'Kaity', 'Initials': 'K', 'LastName': 'Chang', 'Affiliation': ''}, {'ForeName': 'Dennis S', 'Initials': 'DS', 'LastName': 'Chi', 'Affiliation': ''}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Sonoda', 'Affiliation': ''}, {'ForeName': 'Amy K', 'Initials': 'AK', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Cosin', 'Affiliation': ''}, {'ForeName': 'Nadeem R', 'Initials': 'NR', 'LastName': 'Abu-Rustum', 'Affiliation': ''}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Martino', 'Affiliation': ''}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Mueller', 'Affiliation': ''}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Long Roche', 'Affiliation': ''}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Jewell', 'Affiliation': ''}, {'ForeName': 'Vance', 'Initials': 'V', 'LastName': 'Broach', 'Affiliation': ''}, {'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Lambrou', 'Affiliation': ''}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Diaz', 'Affiliation': ''}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Zivanovic', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004243'] 1881,33417346,"Impact of Auricular Neurostimulation in Patients Undergoing Colorectal Surgery with an Enhanced Recovery Protocol: A Pilot Randomized, Controlled Trial.","BACKGROUND Narcotics are the cornerstone of postoperative pain control, but the opioid epidemic and the negative physiological and psychological effects of narcotics implore physicians to utilize nonpharmacological methods of pain control. OBJECTIVE This pilot study investigated a novel neurostimulation device for postoperative analgesia. We hypothesized that active neurostimulation would decrease postoperative narcotic requirements. DESIGN This was a placebo-controlled, double-blinded trial. SETTINGS This trial was conducted at an academic medical center and a Veterans Affairs hospital. PATIENTS This trial included adult patients who underwent elective bowel resection between December 2016 and April 2018. INTERVENTIONS Patients were randomly assigned to receive an active or inactive (sham) device, which was applied to the right ear before surgery and continued for 5 days. MAIN OUTCOME MEASURES The primary outcome was total opioid consumption. The secondary outcomes included pain, nausea, anxiety, return of bowel function, complications, 30-day readmissions, and opioid consumption at 2 weeks and 30 days. RESULTS A total of 57 patients participated and 5 withdrew; 52 patients were included in the analysis. Twenty-eight patients received an active device and 24 received an inactive device. There was no difference in total narcotic consumption between active and inactive devices (90.79 ± 54.93 vs 90.30 ± 43.03 oral morphine equivalents/day). Subgroup analyses demonstrated a benefit for patients after open surgery (p = 0.0278). When patients were stratified by decade, those aged 60 to 70 and >70 years derived a benefit from active devices in comparison with those aged 30 to 40, 40 to 50, and 50 to 60 years old (p = 0.01092). No serious adverse events were related to this study. LIMITATIONS This study was limited by the small sample sizes. CONCLUSIONS No difference in opioid use was found with auricular neurostimulation. However, this pilot study suggests that older patients and those with larger abdominal incisions may benefit from auricular neurostimulation. Further investigation in these high-risk patients is warranted. See Video Abstract at http://links.lww.com/DCR/B452.ClinicalTrials.gov identifier: NCT02892513. IMPACTO DE LA NEUROESTIMULACIN AURICULAR EN PACIENTES SOMETIDOS A CIRUGA COLORRECTAL CON UN PROTOCOLO DE RECUPERACIN MEJORADA UN ENSAYO PILOTO ALEATORIZADO Y CONTROLADO ANTECEDENTES:Los narcóticos son la piedra angular del control del dolor postoperatorio, pero la epidemia de opioides y los efectos fisiológicos y psicológicos negativos de los narcóticos incentivan a los médicos a que utilicen métodos no farmacológicos de control del dolor.OBJETIVO:Este estudio piloto investigó un nuevo dispositivo de neuroestimulación para analgesia postoperatoria. Hipotetizamos que la neuroestimulación activa disminuiría los requerimientos narcóticos postoperatorios.DISEÑO:Este fue un ensayo doble ciego controlado con placebo.ESCENARIO:Esto se llevó a cabo en un centro médico académico y en un hospital de Asuntos de Veteranos (Veterans Affairs hospital).PACIENTES:Este ensayo incluyó pacientes adultos que se sometieron a resección intestinal electiva entre diciembre de 2016 y abril de 2018.INTERVENCIONES:Los pacientes fueron asignados al azar para recibir un dispositivo activo o inactivo (falso), que se aplicó al oído derecho antes de la cirugía y se mantuvo durante 5 días.PRINCIPALES MEDIDAS DE RESULTADO:El resultado primario fue el consumo total de opioides; los resultados secundarios incluyeron dolor, náusea, ansiedad, retorno de la función intestinal, complicaciones, reingresos a 30 días y consumo de opioides a 2 semanas y a 30 días.RESULTADOS:Participaron un total de 57 pacientes y 5 se retiraron; Se incluyeron 52 pacientes en el análisis. Veintiocho pacientes recibieron un dispositivo activo y 24 recibieron un dispositivo inactivo. No hubo diferencias en el consumo total de narcóticos entre los dispositivos activos e inactivos (90.79 ± 54.93 vs 90.30 ± 43.03 equivalentes de morfina oral [OME] / día). Los análisis de subgrupos demostraron un beneficio para los pacientes después de cirugía abierta (p = 0.0278). Cuando los pacientes se estratificaron por década, aquellos de 60-70 y > 70 años obtuvieron un beneficio de los dispositivos activos en comparación con los de 30-40, 40-50 y 50-60 años (p = 0.01092). No hubo eventos adversos graves relacionados con este estudio.LIMITACIONES:Este estudio estuvo limitado por los pequeños tamaños de muestra.CONCLUSIONES:No se encontró diferencia en el uso de opioides con la neuroestimulación auricular. Sin embargo, este estudio piloto sugiere que los pacientes mayores y aquellos con incisiones abdominales más grandes pueden beneficiarse de la neuroestimulación auricular. Está justificada la investigación adicional en estos pacientes de alto riesgo. Consulte Video Resumen en http://links.lww.com/DCR/B452. (Traducción-Dr. Jorge Silva Velazco).",2021,No hubo diferencias en el consumo,"['Patients Undergoing Colorectal Surgery with an Enhanced Recovery Protocol', 'Los pacientes fueron asignados al azar para recibir un dispositivo', 'older patients', 'Este ensayo incluyó pacientes adultos', 'academic medical center and a Veterans Affairs hospital', 'adult patients who underwent elective bowel resection between December 2016 and April 2018', '57 patients participated and 5 withdrew; 52 patients were included in the analysis', 'Este estudio piloto investigó un nuevo dispositivo de neuroestimulación para analgesia postoperatoria', 'centro médico académico y', 'de la cirugía', 'con incisiones abdominales más grandes pueden beneficiarse de la neuroestimulación auricular', 'en un hospital de Asuntos de Veteranos (Veterans Affairs hospital).PACIENTES', 'y aquellos', 'patients were stratified by decade, those aged 60 to 70 and >70 years derived a benefit from active devices in comparison with those aged 30 to 40, 40 to 50, and 50 to 60 years old (p = 0.01092', 'total de narcóticos entre los dispositivos activos']","['placebo', 'active or inactive (sham) device', 'IMPACTO', 'active device and 24 received an inactive device', 'Auricular Neurostimulation', 'DISEÑO']","['serious adverse events', 'total opioid consumption', 'activo o inactivo (falso', 'pain, nausea, anxiety, return of bowel function, complications, 30-day readmissions, and opioid consumption at 2 weeks and 30 days', 'total narcotic consumption', 'postoperative narcotic requirements']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0741614', 'cui_str': 'Bowel resection'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0521307', 'cui_str': 'Neurostimulation procedure'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",57.0,0.164807,No hubo diferencias en el consumo,"[{'ForeName': 'Jacqueline J', 'Initials': 'JJ', 'LastName': 'Blank', 'Affiliation': 'Division of Colorectal Surgery, Medical College of Wisconsin, Wauwatosa, Wisconsin.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Division of Biostatistics, Medical College of Wisconsin, Wauwatosa, Wisconsin.'}, {'ForeName': 'Ziyan', 'Initials': 'Z', 'LastName': 'Yin', 'Affiliation': 'Division of Biostatistics, Medical College of Wisconsin, Wauwatosa, Wisconsin.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Spofford', 'Affiliation': 'Department of Anesthesiology, Medical College of Wisconsin, Wauwatosa, Wisconsin.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Ridolfi', 'Affiliation': 'Division of Colorectal Surgery, Medical College of Wisconsin, Wauwatosa, Wisconsin.'}, {'ForeName': 'Kirk A', 'Initials': 'KA', 'LastName': 'Ludwig', 'Affiliation': 'Division of Colorectal Surgery, Medical College of Wisconsin, Wauwatosa, Wisconsin.'}, {'ForeName': 'Mary F', 'Initials': 'MF', 'LastName': 'Otterson', 'Affiliation': 'Division of Colorectal Surgery, Medical College of Wisconsin, Wauwatosa, Wisconsin.'}, {'ForeName': 'Carrie Y', 'Initials': 'CY', 'LastName': 'Peterson', 'Affiliation': 'Division of Colorectal Surgery, Medical College of Wisconsin, Wauwatosa, Wisconsin.'}]",Diseases of the colon and rectum,['10.1097/DCR.0000000000001752'] 1882,33421091,One-year follow up on post-placental IUD insertion: A randomized clinical trial.,"INTRODUCTION Our objectives were to compare the 1-year follow-up clinical performance of the TCu380A intrauterine device (TCu380A-IUD) and levonorgestrel (LNG) 52-mg intrauterine system (IUS) inserted at post-placental period. MATERIAL AND METHODS We conducted an open-label, parallel-group, randomized clinical trial, 1:1 with pregnant women admitted for childbirth independently of the mode of birth. Our primary outcome was expulsion up to 1 year after device placement by type of IUD and mode of delivery. During the follow up (42, 90 and 365 days (±7 days) after device placement), an ultrasound was performed to evaluate the device position. Kaplan-Meier with log-rank test was used to compare the survival curves of the TCu380A IUD and the LNG IUS. Couple-Years of Protection after insertion of both devices was calculated. RESULTS One hundred and forty women were randomized to the TCu380A IUD (n = 70) or the LNG IUS (n = 70). By the end of the first year after device placement, 38 women experienced device expulsion (27.1%), most of them (33/38; 86.8%) within the first 42 days after delivery. The expulsions were significantly higher among users of TCu380A IUD (39.4%) than among users of the LNG IUS (22.2%; P = .039), and among those with vaginal delivery (43.8%) than among women with cesarean delivery (15%; P = .003). The 1-year cumulative continuation rate was 64.2%, significantly higher for LNG IUS (73.1%) than for TCu380A IUD (54.4%; P = .03), and among women with cesarean delivery (77.6%) than for vaginal delivery (52%; P = .00). The post-placental IUD insertion provided 356.4 Couple-Years of Protection. CONCLUSIONS Two-thirds of women who accepted a post-placental IUD placement still used the device 1 year after childbirth. However, expulsion was the most prevalent reason for discontinuation, mainly within 42 days after device placement. The expulsion rate was significantly higher among TCu380A IUD users and among women with vaginal delivery.",2021,Two-thirds of women who accepted a post-placental IUD placement still used the device one year after childbirth.,"['140 women', 'pregnant women admitted for childbirth independently of the mode of birth']","['LNG IUS', 'TCu380A intrauterine device (TCu380A-IUD) and levonorgestrel (LNG) 52mg intrauterine system (IUS) inserted at post-placental period', 'TCu380A IUD']","['cumulative continuation rate', 'expulsion up to one year after device placement by type of IUD and mode of delivery', 'survival curves', 'expulsion rate', 'device expulsion']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]","[{'cui': 'C4293465', 'cui_str': 'Levonorgestrel Intrauterine System [Kyleena]'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}, {'cui': 'C0015927', 'cui_str': 'Fetal death'}, {'cui': 'C0937459', 'cui_str': 'Levonorgestrel 833 nanogram/hour prolonged-release intrauterine drug delivery system'}, {'cui': 'C4293370', 'cui_str': 'Intrauterine System'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}]","[{'cui': 'C1293107', 'cui_str': 'Expulsion'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0015927', 'cui_str': 'Fetal death'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0549478', 'cui_str': 'Device expulsion'}]",140.0,0.42236,Two-thirds of women who accepted a post-placental IUD placement still used the device one year after childbirth.,"[{'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Marangoni', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Montas', 'Initials': 'M', 'LastName': 'Laporte', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Surita', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Maria B', 'Initials': 'MB', 'LastName': 'Kraft', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Bahamondes', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Cássia R T', 'Initials': 'CRT', 'LastName': 'Juliato', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, University of Campinas (UNICAMP), Campinas, Brazil.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.14081'] 1883,33484479,Protocol for probiotic therapy vs placebo for preterm prelabour rupture of membranes to prolong pregnancy duration (Pro-PPROM) trial.,"BACKGROUND Preterm prelabour rupture of membranes (PPROM) is a common preterm birth antecedent. Preterm infants experience increased adverse newborn outcome risks. Infection is a risk factor for early birth in PPROM. Current management is antibiotic therapy, antenatal corticosteroids and to plan delivery at 37 weeks gestation. The microbiota and probiotics are potentially protective and may improve outcomes. AIMS The primary aim is to evaluate whether oral probiotic therapy (Lactobacillus fermentum CECT5716) administered during PPROM between 24 and 34 weeks gestation prolongs pregnancy duration. The secondary aim is to evaluate maternal and neonatal outcomes. MATERIALS AND METHODS This is a pragmatic, multicentre, double-blind, placebo-controlled randomised controlled trial in Australia. The population will be women with a singleton pregnancy and PPROM less than 34 weeks gestation. The intervention will be an oral probiotic therapy compared with a placebo control. The primary outcome will be the proportion of women still pregnant at seven days following PPROM. One-to-one randomisation will occur within 24 h of PPROM. The trial is powered (80%, alpha = 0.05) to detect an absolute percentage increase in the primary outcome of 30%, (from expected rate of 20% up to 50%). DISCUSSION This trial will provide evidence for the effectiveness of the probiotic in prolonging pregnancy duration. Findings will inform the feasibility of a larger trial to examine the effect of oral probiotics on clinically important maternal and neonatal outcomes in PPROM.",2021,"The trial is powered (80%, alpha = 0.05) to detect an absolute percentage increase in the primary outcome of 30%, (from expected rate of 20% up to 50%). ",['women with a singleton pregnancy and PPROM less than 34\xa0weeks gestation'],"['placebo control', 'placebo', 'oral probiotic therapy (Lactobacillus fermentum CECT5716', 'probiotic therapy vs placebo', 'oral probiotics']","['adverse newborn outcome risks', 'proportion of women still pregnant at seven days following PPROM']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0233308', 'cui_str': 'Spontaneous rupture of fetal membranes'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C2242626', 'cui_str': 'Probiotic therapy'}, {'cui': 'C0317603', 'cui_str': 'lactobacillus fermentum'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0233308', 'cui_str': 'Spontaneous rupture of fetal membranes'}]",,0.511389,"The trial is powered (80%, alpha = 0.05) to detect an absolute percentage increase in the primary outcome of 30%, (from expected rate of 20% up to 50%). ","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Sandeford', 'Affiliation': 'Sydney Medical School Northern, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Nippita', 'Affiliation': 'Sydney Medical School Northern, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Tushar', 'Initials': 'T', 'LastName': 'Bhuta', 'Affiliation': 'Mater Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Patterson', 'Affiliation': 'Sydney Medical School Northern, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Morris', 'Affiliation': 'Sydney Medical School Northern, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Seeho', 'Affiliation': 'Sydney Medical School Northern, The University of Sydney, Sydney, New South Wales, Australia.'}]",The Australian & New Zealand journal of obstetrics & gynaecology,['10.1111/ajo.13313'] 1884,33484775,A randomized placebo-controlled trial of elafibranor in patients with primary biliary cholangitis and incomplete response to UDCA.,"BACKGROUND & AIMS Patients with primary biliary cholangitis (PBC) who have an incomplete response to ursodeoxycholic acid remain at risk of disease progression. We investigated the safety and efficacy of elafibranor, a dual PPARα/δ agonist, in patients with PBC. METHODS This 12-week, double-blind phase II trial enrolled 45 adults with PBC who had incomplete response to ursodeoxycholic acid (alkaline phosphatase levels ≥1.67-fold the upper limit of normal (ULN). Patients were randomly assigned to elafibranor 80 mg, elafibranor 120 mg or placebo. The primary endpoint was the relative change of ALP at 12 weeks (NCT03124108). RESULTS At 12 weeks, ALP was reduced by -48.3±14.8% in the elafibranor 80 mg group (p <0.001 vs. placebo) and by -40.6±17.4% in the elafibranor 120 mg group (p <0.001) compared to a +3.2±14.8% increase in the placebo group. The composite endpoint of ALP ≤1.67-fold the ULN, decrease of ALP >15% and total bilirubin below the ULN was achieved in 67% patients in the elafibranor 80 mg group and 79% patients in the elafibranor 120 mg group, vs. 6.7% patients in the placebo group. Levels of gamma-glutamyltransferase decreased by 37.0±25.5% in the elafibranor 80 mg group (p <0.001) and 40.0±24.1% in the elafibranor 120 mg group (p <0.01) compared to no change (+0.2±26.0%) in the placebo group. Levels of disease markers such as IgM, 5'-nucleotidase or high-sensitivity C-reactive protein were likewise reduced by elafibranor. Pruritus was not induced or exacerbated by elafibranor and patients with pruritus at baseline reported less pruritic symptoms at the end of treatment. All possibly drug-related non-serious adverse events were mild to moderate. CONCLUSION In this randomized phase II trial, elafibranor was generally safe and well tolerated and significantly reduced levels of ALP, composite endpoints of bilirubin and ALP, as well as other markers of disease activity in patients with PBC and an incomplete response to ursodeoxycholic acid. LAY SUMMARY Patients with primary biliary cholangitis (a rare chronic liver disease) that do not respond to standard therapy remain at risk of disease progression toward cirrhosis and impaired quality of life. Elafibranor is a nuclear receptor agonist that we tested in a randomized clinical trial over 12 weeks. It successfully decreased levels of disease activity markers, including alkaline phosphatase. Thus, this study is the foundation for a larger prospective study that will determine the efficacy and safety of this drug as a second-line therapy. CLINICAL TRIAL REGISTRATION NUMBER Clinical Trials.gov NCT03124108.",2021,"Levels of disease markers such as IgM, 5'-nucleotidase or hsCRP were likewise reduced from elafibranor.","['45 adults with PBC who had incomplete response to ursodeoxycholic acid (alkaline phosphatase levels ≥1.67-fold the upper limit of normal (ULN', 'Patients with primary biliary cholangitis (PBC', 'patients with primary biliary cholangitis and incomplete response to UDCA', 'patients with PBC']","['placebo', 'ursodeoxycholic acid', 'elafibranor', 'elafibranor-80 mg, elafibranor-120 mg or placebo', 'elafibranor-120']","['relative change of ALP', 'ALP >15% and total bilirubin below the ULN', 'pruritic symptoms', 'safe and well tolerated', 'Levels of gamma glutamyl transferase', ""Levels of disease markers such as IgM, 5'-nucleotidase or hsCRP"", 'ALP', 'Pruritus']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008312', 'cui_str': 'Primary biliary cholangitis'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}, {'cui': 'C0428332', 'cui_str': 'Alkaline phosphatase level - finding'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0000530', 'cui_str': ""5'-nucleotidase""}, {'cui': 'C0033774', 'cui_str': 'Itching'}]",45.0,0.522158,"Levels of disease markers such as IgM, 5'-nucleotidase or hsCRP were likewise reduced from elafibranor.","[{'ForeName': 'Jörn M', 'Initials': 'JM', 'LastName': 'Schattenberg', 'Affiliation': 'Metabolic Liver Research Program, I. Department of Medicine, University Medical Centre Mainz, Germany. Electronic address: joern.schattenberg@unimedizin-mainz.de.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Pares', 'Affiliation': 'Hospital Clinic, University of Barcelona, CIBERehd, IDIBAPS, Barcelona, Spain.'}, {'ForeName': 'Kris V', 'Initials': 'KV', 'LastName': 'Kowdley', 'Affiliation': 'Liver Institute Northwest, Seattle, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Heneghan', 'Affiliation': 'Institute of Liver Studies, Kings College Hospital, London, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Caldwell', 'Affiliation': 'University of Virginia, Charlottesville, Virginia, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pratt', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Bonder', 'Affiliation': 'Liver Center, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Gideon M', 'Initials': 'GM', 'LastName': 'Hirschfield', 'Affiliation': 'Toronto Centre for Liver Disease, University Health Network and University of Toronto, Toronto, Canada.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Levy', 'Affiliation': 'Division of Hepatology, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Vierling', 'Affiliation': 'Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jones', 'Affiliation': 'Newcastle University Medical School, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Tailleux', 'Affiliation': 'Université Lille, Inserm, CHU Lille, Institut Pasteur de Lille, U1011-EGID, Lille, France.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Staels', 'Affiliation': 'Université Lille, Inserm, CHU Lille, Institut Pasteur de Lille, U1011-EGID, Lille, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Megnien', 'Affiliation': 'GENFIT, 885 Avenue Eugene Avinee, 59120, Loos, France.'}, {'ForeName': 'Remy', 'Initials': 'R', 'LastName': 'Hanf', 'Affiliation': 'GENFIT, 885 Avenue Eugene Avinee, 59120, Loos, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Magrez', 'Affiliation': 'GENFIT, 885 Avenue Eugene Avinee, 59120, Loos, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Birman', 'Affiliation': 'GENFIT, 885 Avenue Eugene Avinee, 59120, Loos, France.'}, {'ForeName': 'Velimir', 'Initials': 'V', 'LastName': 'Luketic', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Virginia Commonwealth University Health System, Richmond, Virginia, USA.'}]",Journal of hepatology,['10.1016/j.jhep.2021.01.013'] 1885,33483447,Tourniquet use in total knee replacement surgery: a feasibility study and pilot randomised controlled trial (SAFE-TKR study).,"INTRODUCTION Tourniquets are routinely used during total knee replacement (TKR) surgery. They could increase the risk of thromboembolic events including cerebral emboli, cognitive decline, pain and other adverse events (AEs). A randomised controlled trial to assess whether tourniquet use might safely be avoided is therefore warranted but it is unclear whether such a trial would be feasible. METHODS In a single-site feasibility study and pilot randomised controlled trial, adults having a TKR were randomised to surgery with an inflated tourniquet versus a non-inflated tourniquet. Participants underwent brain MRI preoperatively and within 2 days postoperatively. We assessed cognition using the Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA) and Oxford Cognitive Screen (OCS) and thigh pain using a Visual Analogue Scale at baseline and days 1 and 2, and 1 week postsurgery. AEs related to surgery were recorded up to 12 months. RESULTS We randomised 53 participants (27 tourniquet inflated and 26 tourniquet not inflated). Fifty-one participants received care per-protocol (96%) and 48 (91%) were followed up at 12 months. One new ischaemic brain lesion was detected. Of the cognitive tests, MoCA was easy to summarise, sensitive to change with lower ceiling effects compared with OCS and MMSE. There was a trend towards more thigh pain (mean 49.6 SD 30.4 vs 36.2 SD 28 at day 1) and more AEs related to surgery (21 vs 9) in participants with an inflated tourniquet compared with those with a tourniquet not inflated. CONCLUSION A full trial is feasible, but using MRI as a primary outcome is unlikely to be appropriate or feasible. Suitable primary outcomes would be cognition measured using MoCA, pain and AEs, all of which warrant investigation in a large multicentre trial. TRIAL REGISTRATION NUMBER ISRCTN20873088.",2021,"Of the cognitive tests, MoCA was easy to summarise, sensitive to change with lower ceiling effects compared with OCS and MMSE.","['adults having a TKR', '53 participants (27 tourniquet inflated and 26 tourniquet not inflated', 'total knee replacement surgery']","['total knee replacement (TKR) surgery', 'surgery with an inflated tourniquet versus a non-inflated tourniquet']","['risk of thromboembolic events including cerebral emboli, cognitive decline, pain and other adverse events (AEs', 'cognition using the Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA) and Oxford Cognitive Screen (OCS) and thigh pain using a Visual Analogue Scale', 'thigh pain', 'cognition measured using MoCA, pain and AEs']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0007780', 'cui_str': 'Cerebral embolism'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C4076343', 'cui_str': 'Oxford Cognitive Screen'}, {'cui': 'C0241374', 'cui_str': 'Thigh pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",53.0,0.325778,"Of the cognitive tests, MoCA was easy to summarise, sensitive to change with lower ceiling effects compared with OCS and MMSE.","[{'ForeName': 'Peter David Henry', 'Initials': 'PDH', 'LastName': 'Wall', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick Warwick Medical School, Coventry, UK p.d.h.wall@warwick.ac.uk.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Ahmed', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick Warwick Medical School, Coventry, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Edwin', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick Warwick Medical School, Coventry, UK.'}, {'ForeName': 'Muhamed M', 'Initials': 'MM', 'LastName': 'Farhan-Alanie', 'Affiliation': 'Trauma and Orthopaedic, Warwick Clinical Trials Unit, Coventry, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Parsons', 'Affiliation': 'Division of Health Sciences, University of Warwick, Coventry, Warks, UK.'}, {'ForeName': 'Andrew James', 'Initials': 'AJ', 'LastName': 'Price', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Warwick', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick Warwick Medical School, Coventry, UK.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Hutchinson', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Underwood', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Metcalfe', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick Warwick Medical School, Coventry, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-043564'] 1886,33460301,Response to ibudilast treatment according to progressive multiple sclerosis disease phenotype.,"OBJECTIVE Determine whether a treatment effect of ibudilast on brain atrophy rate differs between participants with primary (PPMS) and secondary (SPMS) progressive multiple sclerosis. BACKGROUND Progressive forms of MS are both associated with continuous disability progression. Whether PPMS and SPMS differ in treatment response remains unknown. DESIGN/METHODS SPRINT-MS was a randomized, placebo-controlled 96-week phase 2 trial in both PPMS (n = 134) and SPMS (n = 121) patients. The effect of PPMS and SPMS phenotype on the rate of change of brain atrophy measured by brain parenchymal fraction (BPF) was examined by fitting a three-way interaction linear-mixed model. Adjustment for differences in baseline demographics, disease measures, and brain size was explored. RESULTS Analysis showed that there was a three-way interaction between the time, treatment effect, and disease phenotype (P < 0.06). After further inspection, the overall treatment effect was primarily driven by patients with PPMS (P < 0.01), and not by patients with SPMS (P = 0.97). This difference may have been due to faster brain atrophy progression seen in the PPMS placebo group compared to SPMS placebo (P < 0.02). Although backward selection (P < 0.05) retained age, T2 lesion volume, RNFL, and longitudinal diffusivity as significant baseline covariates in the linear-mixed model, the adjusted overall treatment effect was still driven by PPMS (P < 0.01). INTERPRETATION The previously reported overall treatment effect of ibudilast on worsening of brain atrophy in progressive MS appears to be driven by patients with PPMS that may be, in part, because of the faster atrophy progression rates seen in the placebo-treated group.",2021,"Although backward selection (P < 0.05) retained age, T2 lesion volume, RNFL, and longitudinal diffusivity as significant baseline covariates in the linear-mixed model, the adjusted overall treatment effect was still driven by PPMS (P < 0.01). ","['n\xa0=\xa0134) and SPMS (n\xa0=\xa0121) patients', 'participants with primary (PPMS) and secondary (SPMS) progressive multiple sclerosis']","['PPMS placebo', 'PPMS', 'SPMS placebo', 'placebo']","['baseline demographics, disease measures, and brain size', 'rate of change of brain atrophy measured by brain parenchymal fraction (BPF']","[{'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0038111', 'cui_str': 'Saint Pierre and Miquelon'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0751965', 'cui_str': 'Secondary progressive multiple sclerosis'}]","[{'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0235946', 'cui_str': 'Cerebral atrophy'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]",121.0,0.115452,"Although backward selection (P < 0.05) retained age, T2 lesion volume, RNFL, and longitudinal diffusivity as significant baseline covariates in the linear-mixed model, the adjusted overall treatment effect was still driven by PPMS (P < 0.01). ","[{'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Goodman', 'Affiliation': 'Department of Neurology, University of Rochester, Rochester, New York, USA.'}, {'ForeName': 'Janel K', 'Initials': 'JK', 'LastName': 'Fedler', 'Affiliation': 'University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Yankey', 'Affiliation': 'University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Klingner', 'Affiliation': 'University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Dixie J', 'Initials': 'DJ', 'LastName': 'Ecklund', 'Affiliation': 'University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Christopher V', 'Initials': 'CV', 'LastName': 'Goebel', 'Affiliation': 'Mellen Center for Multiple Sclerosis, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Bermel', 'Affiliation': 'Mellen Center for Multiple Sclerosis, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Chase', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Coffey', 'Affiliation': 'University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Klawiter', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Naismith', 'Affiliation': 'Department of Neurology, Washington University, St Louis, Missouri, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Fox', 'Affiliation': 'Mellen Center for Multiple Sclerosis, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of clinical and translational neurology,['10.1002/acn3.51251'] 1887,33453563,Association between COMT methylation and response to treatment in children with ADHD.,"BACKGROUND COMT had been considered a promising candidate gene in pharmacogenetic studies in ADHD; yet the findings from these studies have been inconsistent. Part of these inconsistencies could be related to epigenetic mechanisms (including DNA methylation). Here we investigated the role of genetic variants of the COMT gene on the methylation levels of CpG sites in the same gene and explored the effect of methylation on methylphenidate (MPH) and placebo (PBO) response in children with ADHD. METHODS Two hundred and thirty children with ADHD (6-12 years) participated in a randomized, double-blind, placebo-controlled crossover trial with MPH. Univariate analysis was performed to examine the associations between genotypes in the COMT gene and DNA methylation in the same genetic loci. Association between the DNA methylation of 11 CpG sites and PBO/MPH responses were then assessed using spearman's correlation analysis in 212 children. Multiple linear regression analyses were performed to test the interaction between these factors while accounting for sex. RESULTS Associations were observed between specific genetic variants and methylation level of cg20709110. Homozygous genotypes of GG (rs6269), CC (rs4633), GG (rs4818), Val/Val (rs4680) and the haplotype (ACCVal/GCGVal) were significantly associated with higher level of methylation. This CpG showed a significant correlation with placebo response (r = -0.15, P = 0.045) according to the teachers' evaluation, and a close-to significance correlation with response to MPH according to parents' evaluation (r = -0.134, p = 0.051). Regression analysis showed that in the model including rs4818, sex and DNA methylation of cg20709110 contributed significantly to treatment response. CONCLUSIONS These preliminary results could provide evidence for the effect of genetic variations on methylation level and the involvement of the epigenetic variation of COMT loci in modulating the response to treatment in ADHD. TRIAL REGISTRATION clinicaltrials.gov, number NCT00483106.",2021,"This CpG showed a significant correlation with placebo response (r = -0.15, P = 0.045) according to the teachers' evaluation, and a close-to significance correlation with response to MPH according to parents' evaluation (r = -0.134, p = 0.051).","['children with ADHD', '212 children', 'Two hundred and thirty children with ADHD (6-12 years']","['MPH', 'placebo']","['Homozygous genotypes of GG (rs6269), CC (rs4633), GG (rs4818), Val/Val (rs4680) and the haplotype (ACCVal/GCGVal', 'methylphenidate (MPH) and placebo (PBO) response', 'PBO/MPH responses']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0019904', 'cui_str': 'Homozygote'}, {'cui': 'C0042285', 'cui_str': 'Valine'}, {'cui': 'C0018591', 'cui_str': 'Haplotypes'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",230.0,0.141356,"This CpG showed a significant correlation with placebo response (r = -0.15, P = 0.045) according to the teachers' evaluation, and a close-to significance correlation with response to MPH according to parents' evaluation (r = -0.134, p = 0.051).","[{'ForeName': 'Weam', 'Initials': 'W', 'LastName': 'Fageera', 'Affiliation': 'Douglas Mental Health University Institute, Montreal, Quebec, Canada; Department of Human Genetics, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Chaumette', 'Affiliation': 'Institute of Psychiatry and Neurosciences of Paris, Paris, France; Department of Neurology and Neurosurgery, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Marie-Ève', 'Initials': 'MÈ', 'LastName': 'Fortier', 'Affiliation': 'Douglas Mental Health University Institute, Montreal, Quebec, Canada.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Grizenko', 'Affiliation': 'Douglas Mental Health University Institute, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Aurelie', 'Initials': 'A', 'LastName': 'Labbe', 'Affiliation': 'Department of Decision Sciences, HEC Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Sarojini M', 'Initials': 'SM', 'LastName': 'Sengupta', 'Affiliation': 'Douglas Mental Health University Institute, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Ridha', 'Initials': 'R', 'LastName': 'Joober', 'Affiliation': 'Douglas Mental Health University Institute, Montreal, Quebec, Canada; Department of Human Genetics, McGill University, Montreal, Quebec, Canada; Department of Neurology and Neurosurgery, McGill University, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada. Electronic address: ridha.joober@mcgill.ca.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2021.01.008'] 1888,33485836,Effectiveness of a Functional Rehabilitation Program for Upper Limb Apraxia in Poststroke Patients: A Randomized Controlled Trial.,"OBJECTIVE To analyze the effectiveness of a home-based restorative and compensatory upper limb apraxia (ULA) rehabilitation program. DESIGN Randomized controlled trial. SETTING Neurology Unit of San Cecilio Hospital and 2 private and specialized health care centers. PARTICIPANTS Community dwelling participants (N=38) between the ages of 25 and 95 years old (sex ratio, 1:1) with unilateral mild-to-moderate poststroke lesions (time of evolution since stroke, 12.03±8.98mo) and secondary ULA. INTERVENTIONS Participants were randomly assigned to an 8-week combined ULA functional rehabilitation group (n=19) 3 days per week for 30 minutes or to a traditional health care education protocol group (n=19) once a month for 8 weeks. Both interventions were conducted at home. MAIN OUTCOME MEASURES Sociodemographic and clinical data, Barthel Index (primary outcome), Lawton and Brody Scale, observation and scoring activities of daily living, the De Renzi tests for ideational and ideomotor apraxia and imitating gestures test, recognition of gestures, test for upper limb apraxia , and stroke-specific quality of life scale were assessed at 3 time points: baseline, posttreatment (8wk), and follow-up (8wk). RESULTS There were statistically significant differences among the groups regarding ideomotor apraxia, imitating gestures, global recognition of gestures, intransitive gestures, and comprehension of gesture production (P<.05) in favor of the experimental group. However, no statistically significant differences were found between the groups regarding functionality or quality of life (P>.05). Regarding the within-group effect, statistically significant differences were found in all neuropsychological outcomes at posttreatment and follow-up (P<.05). CONCLUSION A functional rehabilitation program was found to be superior to a traditional health care education program and resulted in improvements in neuropsychological functioning in ULA poststroke. Conventional education showed an insufficient effect on apraxia recovery. Further studies with larger sample sizes are needed to determine the effect of rehabilitation strategies on functionality and quality of life of poststroke ULA patients.",2021,A functional rehabilitation program was superior to a traditional healthcare education program and resulted in improvements in the neuropsychological functioning in ULA poststroke.,"['38 community dwelling participants (25-95 years old, sex ratio 1:1) with unilateral mild-to-moderate poststroke lesions (time of evolution since stroke (months) 12.03±8.98) and secondary ULA', 'Neurology Unit of San Cecilio Hospital, and two private and specialized healthcare centers', 'poststroke ULA patients', 'upper limb apraxia in poststroke patients']","['functional rehabilitation program', 'traditional healthcare education protocol group', 'ULA functional rehabilitation', 'home-based restorative and compensatory upper limb apraxia (ULA) rehabilitation program']","['functionality or quality of life', 'recognition of gestures, TULIA, and stroke-specific quality of life scale (SSQOL-38', 'Sociodemographic and clinical data, Barthel Index (primary outcome), Lawton and Brody Scale, Observation and scoring-ADL, the De Renzi tests for ideational and ideomotor apraxia and imitating gestures test', 'neuropsychological outcomes', 'ideomotor apraxia, imitating gestures, global recognition of gestures, intransitive gestures, and comprehension of gesture production', 'apraxia recovery']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0036893', 'cui_str': 'Sex Ratio'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0003635', 'cui_str': 'Apraxia'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0454532', 'cui_str': 'Functional rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0003635', 'cui_str': 'Apraxia'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0017510', 'cui_str': 'Gestures'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0234523', 'cui_str': 'Classic apraxia'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0003635', 'cui_str': 'Apraxia'}]",38.0,0.0783492,A functional rehabilitation program was superior to a traditional healthcare education program and resulted in improvements in the neuropsychological functioning in ULA poststroke.,"[{'ForeName': 'María Encarnación', 'Initials': 'ME', 'LastName': 'Aguilar-Ferrándiz', 'Affiliation': 'Instituto de Investigación Biosanitaria Granada ibs.GRANADA. Department of Physical Therapy, Faculty of Health Science, University of Granada (UGR), Granada, Spain. Electronic address: encaguilar@hotmail.com.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Toledano-Moreno', 'Affiliation': 'Instituto de Investigación Biosanitaria Granada ibs.GRANADA. Department of Physical Therapy, Faculty of Health Science, University of Granada (UGR), Granada, Spain.'}, {'ForeName': 'María Carmen', 'Initials': 'MC', 'LastName': 'García-Ríos', 'Affiliation': 'Instituto de Investigación Biosanitaria Granada ibs.GRANADA. Department of Physical Therapy, Faculty of Health Science, University of Granada (UGR), Granada, Spain.'}, {'ForeName': 'Rosa María', 'Initials': 'RM', 'LastName': 'Tapia-Haro', 'Affiliation': 'Instituto de Investigación Biosanitaria Granada ibs.GRANADA. Department of Physical Therapy, Faculty of Health Science, University of Granada (UGR), Granada, Spain.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Barrero-Hernández', 'Affiliation': 'Neurology División, San Cecilio Hospital, Granada, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Casas-Barragán', 'Affiliation': 'Instituto de Investigación Biosanitaria Granada ibs.GRANADA. Department of Physical Therapy, Faculty of Health Science, University of Granada (UGR), Granada, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Pérez-Mármol', 'Affiliation': 'Instituto de Investigación Biosanitaria Granada ibs.GRANADA. Department of Physical Therapy, Faculty of Health Science, University of Granada (UGR), Granada, Spain.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.12.015'] 1889,33439864,An examination of perseverative errors and cognitive flexibility in autism.,"Perseveration is a well-replicated finding in autism. The aim of this study was to examine how the context of the task influences performance with respect to this phenomenon. We randomly assigned 137 children aged 6-12 with and without autism to complete a modified card-sorting task under one of two conditions: Children were either told the sorting rules on each trial (Explicit), or were given feedback to formulate the rules themselves (Implicit). While performance was enhanced on the Explicit condition for participants without autism, the participants with autism were disadvantaged by this manipulation. In contrast, there were few differences in performance between groups on the Implicit condition. Exploratory analyses were used to examine this unexpected result; increased autism symptomology was associated with poorer performance.",2021,"While performance was enhanced on the Explicit condition for participants without autism, the participants with autism were disadvantaged by this manipulation.","['137 children aged 6-12 with and without autism to complete a modified card-sorting task under one of two conditions: Children', 'participants without autism, the participants with autism', 'autism']",[],['autism symptomology'],"[{'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",[],"[{'cui': 'C0004352', 'cui_str': 'Autistic disorder'}]",137.0,0.0594402,"While performance was enhanced on the Explicit condition for participants without autism, the participants with autism were disadvantaged by this manipulation.","[{'ForeName': 'Oriane', 'Initials': 'O', 'LastName': 'Landry', 'Affiliation': 'School of Psychology, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Mitchell', 'Affiliation': 'School of Psychology, University of Nottingham, Nottingham, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0223160'] 1890,33443588,Nipple shield use does not impact sucking dynamics in breastfeeding infants of mothers with nipple pain.,"Nipple shields (shield) may reduce pain during breastfeeding, but the impact on infant sucking dynamics is not known. We examined the effects of shield use on sucking dynamics, milk removal and nipple pain in two groups of breastfeeding dyads: pain group (PG): shield used for nipple pain; comparison group (CG): no breastfeeding difficulties. Twenty PG (6 ± 4 weeks postnatal) and 28 CG dyads (8 ± 6 weeks postnatal) attended 2 monitored breastfeeding sessions with shield use randomised. Within-subject outcomes were compared. PG: shield use did not affect intra-oral vacuum (peak p = 0.17, baseline p = 0.59), sucking frequency (p = 0.20) or milk transfer (40 mL vs 48 mL, p = 0.80; percentage of available milk removed (PAMR) 55% vs 57%, p = 0.88), and reduced McGill pain scores (p = 0.012). CG: shield use increased non-nutritive sucking (10% more, p = 0.049), and reduced nutritive sucking (18% less, p = 0.017) and milk transfer (63 mL vs 31 mL p < 0.001, PAMR 65% vs 36% p < 0.001). For both groups, feeding duration increased by 2 min (p < 0.0001) and non-nutritive portions of the feed increased with shield use.Conclusion: Nipple shield use improved maternal comfort and did not impact milk removal or sucking strength in PG, but significantly reduced milk transfer and nutritive sucking in CG. What is Known: • Mothers report that nipple shields reduce nipple pain and enable continued breastfeeding. • Concerns that nipple shield use may reduce milk transfer and alter infant sucking patterns are based on limited published evidence. What is New: • Nipple shield use is associated with a 25% reduction in pain scores in breastfeeding mothers with chronic nipple pain. • Milk transfer is not reduced in dyads that regularly use a shield for chronic nipple pain. • Intra-oral vacuums are not impacted by nipple shield use in mothers experiencing pain.",2021,"For both groups, feeding duration increased by 2 min (p < 0.0001) and non-nutritive portions of the feed increased with shield use.","['breastfeeding mothers with chronic nipple pain', 'mothers experiencing pain', 'breastfeeding infants of mothers with nipple pain']","['nipple pain; comparison group (CG): no breastfeeding difficulties', 'CG']","['feeding duration', 'maternal comfort', 'reduced nutritive sucking', 'pain', 'non-nutritive sucking', 'milk transfer and nutritive sucking', 'nipple pain', 'Milk transfer', 'sucking frequency', 'sucking dynamics, milk removal and nipple pain', 'pain scores', 'milk transfer', 'intra-oral vacuum', 'McGill pain scores']","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0240515', 'cui_str': 'Nipple pain'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0240515', 'cui_str': 'Nipple pain'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1998999', 'cui_str': 'Difficulty performing breast-feeding'}]","[{'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1271035', 'cui_str': 'Provision of non-nutritive sucking'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0240515', 'cui_str': 'Nipple pain'}, {'cui': 'C0233927', 'cui_str': 'Sucking'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}]",,0.0943655,"For both groups, feeding duration increased by 2 min (p < 0.0001) and non-nutritive portions of the feed increased with shield use.","[{'ForeName': 'Viviane Silva', 'Initials': 'VS', 'LastName': 'Coentro', 'Affiliation': 'School of Molecular Sciences, Faculty of Science, The University of Western Australia, M310, 35 Stirling Highway, Crawley, Western Australia, 6009, Australia.'}, {'ForeName': 'Sharon Lisa', 'Initials': 'SL', 'LastName': 'Perrella', 'Affiliation': 'School of Molecular Sciences, Faculty of Science, The University of Western Australia, M310, 35 Stirling Highway, Crawley, Western Australia, 6009, Australia. sharon.perrella@uwa.edu.au.'}, {'ForeName': 'Ching Tat', 'Initials': 'CT', 'LastName': 'Lai', 'Affiliation': 'School of Molecular Sciences, Faculty of Science, The University of Western Australia, M310, 35 Stirling Highway, Crawley, Western Australia, 6009, Australia.'}, {'ForeName': 'Alethea', 'Initials': 'A', 'LastName': 'Rea', 'Affiliation': 'Mathematics and Statistics, Murdoch University, 90 South Street, Murdoch, Western Australia, 6150, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dymock', 'Affiliation': 'Centre for Applied Statistics, The University of Western Australia, 35 Stirling Highway, Crawley, Western Australia, 6009, Australia.'}, {'ForeName': 'Donna Tracy', 'Initials': 'DT', 'LastName': 'Geddes', 'Affiliation': 'School of Molecular Sciences, Faculty of Science, The University of Western Australia, M310, 35 Stirling Highway, Crawley, Western Australia, 6009, Australia.'}]",European journal of pediatrics,['10.1007/s00431-020-03901-3'] 1891,33419674,"Effects and safety of herbal medicines among community-dwelling residents during COVID-19 pandemic: A large prospective, randomized controlled trial (RCT).","BACKGROUND Since the declaration of COVID-19 as a global pandemic by the World Health Organization, countries are struggling with a shortage of medical capacities. It would be essential if the risk for preventable comorbidities, such as the common cold, can be reduced or prevented, so that the scarce medical resources and facilities can be focused on COVID-19. PURPOSE To evaluate the effects of two herbal medicines (Jinhaoartemisia antipyretic granules and Huoxiangzhengqi oral liquids) in reducing the risk of the common cold in community-dwelling residents in China during the COVID-19 outbreak. STUDY DESIGN A prospective open-label, parallel-group, cluster-randomized controlled trial (RCT), was conducted in Chengdu, China. METHODS A total of 22,065 participants from 11 communities were recruited during a period of one month. The trial started on 30 January and participants were followed up till 29 February 2020. Participants were randomly assigned to receive either a five-day herbal medicine therapy plus a reference manual or a reference manual only if they were allocated to the control group. The primary endpoint was the occurrence of patient-reported common cold symptoms. The secondary endpoint was the time in days from the receipt of herbal drugs/reference manual and the occurrence of the common cold symptoms. RESULTS Use of herbal medicine reduced the risk of the common cold by 89.6% (95% CI, 52.9% to 97.7%) in all community-dwelling residents, and by 94.0% (95% CI, 52.1% to 99.2%) in residents aged between 16 and 59 years old. Sensitivity analyses showed similar results. CONCLUSION This community-based RCT found that the use of a herbal medicine therapy (Jinhaoartemisia antipyretic granules and Huoxiangzhengqi oral liquids) could significantly reduce the risks of the common cold among community-dwelling residents, suggesting that herbal medicine may be a useful approach for public health intervention to minimize preventable morbidity during COVID-19 outbreak.",2021,"RESULTS Use of herbal medicine reduced the risk of the common cold by 89.6% (95% CI, 52.9% to 97.7%) in all community-dwelling residents, and by 94.0% (95% CI, 52.1% to 99.2%) in residents aged between 16 and 59 years old.","['community-dwelling residents in China during the COVID-19 outbreak', '30 January and participants were followed up till 29 February 2020', '22,065 participants from 11 communities were recruited during a period of one month', 'community-dwelling residents during COVID-19 pandemic']","['five-day herbal medicine therapy plus a reference manual or a reference manual', 'herbal medicine therapy (Jinhaoartemisia antipyretic granules and Huoxiangzhengqi oral liquids', 'herbal medicine', 'herbal medicines', 'herbal medicines (Jinhaoartemisia antipyretic granules and Huoxiangzhengqi oral liquids']","['time in days from the receipt of herbal drugs/reference manual and the occurrence of the common cold symptoms', 'occurrence of patient-reported common cold symptoms', 'risk of the common cold']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012652', 'cui_str': 'Disease outbreak'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0025125', 'cui_str': 'Herbs, Medicinal'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0003419', 'cui_str': 'Antipyretic Agents'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C1273619', 'cui_str': 'Oral Liquid Product'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0009443', 'cui_str': 'Common cold'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",22065.0,0.267306,"RESULTS Use of herbal medicine reduced the risk of the common cold by 89.6% (95% CI, 52.9% to 97.7%) in all community-dwelling residents, and by 94.0% (95% CI, 52.1% to 99.2%) in residents aged between 16 and 59 years old.","[{'ForeName': 'Bohua', 'Initials': 'B', 'LastName': 'Yan', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Zhiwei', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'BeijingKeyTech Statistical Consulting Co. Ltd, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': 'Fudan University, Shanghai, China.'}, {'ForeName': 'Minghui', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'University of Tennessee Health Science Center, Memphis, Tennessee, United States.'}, {'ForeName': 'Jieping', 'Initials': 'J', 'LastName': 'Zeng', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Jianyuan', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China. Electronic address: tangjianyuan163@163.com.'}, {'ForeName': 'Z Kevin', 'Initials': 'ZK', 'LastName': 'Lu', 'Affiliation': 'University of South Carolina College of Pharmacy, Columbia, South Carolina, United States. Electronic address: lu32@email.sc.edu.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Ding', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Jielai', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': ""People's Liberation Army Air Force Military Medical University, Xi'an, China. Electronic address: xiajielai@fmmu.edu.cn.""}, {'ForeName': 'Qiaoling', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Jundong', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Wenyuan', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Xiaoya', 'Initials': 'X', 'LastName': 'Sang', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Xiaomo', 'Initials': 'X', 'LastName': 'Xiong', 'Affiliation': 'University of South Carolina College of Pharmacy, Columbia, South Carolina, United States.'}, {'ForeName': 'Shiyun', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Mengyao', 'Initials': 'M', 'LastName': 'Tao', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Chunguang', 'Initials': 'C', 'LastName': 'Xie', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China. Electronic address: xcg718@aliyun.com.'}, {'ForeName': 'Shuguang', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Chengdu University of Traditional Chinese Medicine, Chengdu, China. Electronic address: ysg28588@126.com.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2020.153403'] 1892,33418053,A randomized trial of subcutaneous allergy immunotherapy in inner-city children with asthma less than 4 years of age.,"BACKGROUND Allergic sensitization to environmental allergens in the first years of life is a strong predictor of asthma morbidity in children. Allergy immunotherapy can improve asthma and allergy outcomes, but its efficacy in inner-city, atopic children of less than 4 years of age with recurrent wheezing has not yet been established. OBJECTIVE To determine whether subcutaneous allergy immunotherapy improves asthma in a population of US inner-city children when started at less than 4 years of age. METHODS In a randomized controlled, open-label phase I-II single-center trial in the Bronx, New York, 58 children with recurrent wheezing or physician-diagnosed asthma were randomized to receive asthma standard of care treatment with or without a 3-year course of multiple allergen subcutaneous immunotherapy. RESULTS A total of 23 children in the control group and 27 children in the immunotherapy group began the study. A total of 20 of 27 children commencing immunotherapy completed at least 2 years of immunotherapy. There was no difference in asthma medication and symptom scores between the treatment or control groups over time. Similarly, naso-ocular symptoms and allergy medication use were similar in both groups over time. Nevertheless, asthma-related quality of life improved in the immunotherapy group compared with the control group (P = .03). CONCLUSION With the exception of asthma-related quality of life, allergy immunotherapy was ineffective in improving asthma outcomes in this population of inner-city children of less than 4 years of age. These findings suggest that the effects of allergy immunotherapy depend on population-specific factors and highlight the importance of precise predictors of immunotherapy efficacy. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT01028560.",2021,"Nevertheless, asthma related quality of life improved in the immunotherapy group compared to the control group (p=0.03). ","['asthma in a population of U.S. inner-city children when started at < 4 years of age', 'children', 'population of inner-city children < 4 years of age', 'atopic, inner-city children < 4 years of age with recurrent wheeze', 'inner-city asthmatic children <4 years of age', '58 children with recurrent wheeze or physician-diagnosed asthma', '20 of 27 children commencing immunotherapy completed at least 2 years of immunotherapy', '23 children in the control group and 27 children in the immunotherapy group began the study']","['asthma standard of care treatment with or without a 3-year course of multiple allergen subcutaneous immunotherapy', 'Allergy immunotherapy', 'subcutaneous allergy immunotherapy']","['asthma related quality of life', 'naso-ocular symptoms and allergy medication', 'asthma medication and symptom scores', 'asthma outcomes', 'quality of life']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0557849', 'cui_str': 'Inner city'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0392707', 'cui_str': 'Atopy'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C0413381', 'cui_str': 'Subcutaneous immunotherapy'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0074744', 'cui_str': 'sodium metabisulfite'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013182', 'cui_str': 'Allergy to drug'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",58.0,0.061176,"Nevertheless, asthma related quality of life improved in the immunotherapy group compared to the control group (p=0.03). ","[{'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'de Vos', 'Affiliation': 'Division of Allergy and Immunology, Albert Einstein College of Medicine, Bronx, New York; Department of Pediatrcis, Jacobi Medical Center, Bronx, New York; Division of Allergy and Immunology, Department of Pediatrics, Montefiore Medical Center, Bronx, New York. Electronic address: gabriele.devos@nychhc.org.'}, {'ForeName': 'Shankar', 'Initials': 'S', 'LastName': 'Viswanathan', 'Affiliation': 'Department of Epidemiology and Biostatistics, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Yikania', 'Initials': 'Y', 'LastName': 'Pichardo', 'Affiliation': 'Department of Pediatrcis, Jacobi Medical Center, Bronx, New York.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Nazari', 'Affiliation': 'Department of Medicine, Jacobi Medical Center, Bronx, New York.'}, {'ForeName': 'Yurydia', 'Initials': 'Y', 'LastName': 'Jorge', 'Affiliation': 'Department of Pediatrcis, Jacobi Medical Center, Bronx, New York.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Ren', 'Affiliation': 'Department of Pediatrics, University of Central Florida, Florida Hospital Medical Center, Orlando, Florida.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Serebrisky', 'Affiliation': 'Department of Medicine, Jacobi Medical Center, Bronx, New York.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rosenstreich', 'Affiliation': 'Division of Pediatric Pulmonology, Jacobi Medical Center, Bronx, New York.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wiznia', 'Affiliation': 'Division of Allergy and Immunology, Department of Pediatrics, Montefiore Medical Center, Bronx, New York.'}]","Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology",['10.1016/j.anai.2020.12.016'] 1893,33421333,Effect of expiratory muscle training on peak cough flow in children and adolescents with cystic fibrosis: A randomized controlled trial.,"BACKGROUND Cough is an important defense and airway clearance mechanism for removing thick and viscous secretions in cystic fibrosis (CF). The primary aim of this study was to investigate the effect of expiratory muscle training (EMT) on peak cough flow (PCF) and secondly on respiratory muscle functions, functional exercise capacity, and quality of life (QoL) in CF. METHODS Thirty patients were randomized as training and sham groups. Both groups were trained with the EMT protocol, which involved twice per day for at least 5 days per week for 6 weeks. The training intensity in the training group was 30% of the maximal expiratory pressure (MEP). In the sham group, it remained at the lowest pressure (5 cmH 2 O). The primary outcome was PCF. The secondary outcomes were MEP, maximal inspiratory pressure (MIP), spirometric measures, six-minute walking distance (6MWD), and QoL (Cystic Fibrosis Questionnaire-Revised). RESULTS Twenty-eight patients completed the study. Changes in PCF (p = .041) and MEP (p = .003) were higher in the training group than the sham group. Also, treatment burden (p = .008), digestive symptoms (p = .019), and vitality (p = .042) in QoL were more improved in the training group. MIP (p = .028) and 6MWD (p = .035) changed significantly only in the training group. Spirometric measurements did not change (p > .05). CONCLUSIONS The results of the study show that EMT could improve PCF, MEP, treatment burden, digestive symptoms, and vitality domains of QoL in patients with CF. Moreover, MIP and functional exercise capacity improved in the training group with EMT.",2021,MIP (p=0.028) and 6MWD (p=0.035) changed significantly only in the training group.,"['Twenty-eight patients completed the study', 'cystic fibrosis (CF', 'Thirty patients', 'Children and Adolescents with Cystic Fibrosis']","['expiratory muscle training (EMT', 'EMT', 'Expiratory Muscle Training']","['6MWD', 'digestive symptoms', 'MEP, maximal inspiratory pressure (MIP), spirometric measures, six-minute walking distance (6MWD), and QoL (Cystic Fibrosis Questionnaire-Revised', 'peak cough flow (PCF) and secondly on respiratory muscle functions, functional exercise capacity, and quality of life (QoL', 'Spirometric measurements', 'PCF', 'Peak Cough Flow', 'vitality', 'MIP', 'PCF, MEP, treatment burden, digestive symptoms, and vitality domains of QoL', 'Changes in PCF', 'MIP and functional exercise capacity']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0476288', 'cui_str': 'Digestive symptom'}, {'cui': 'C4082175', 'cui_str': 'Maximum Expiratory Pressure'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0376579', 'cui_str': 'Macrophage Inflammatory Proteins'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",30.0,0.0677603,MIP (p=0.028) and 6MWD (p=0.035) changed significantly only in the training group.,"[{'ForeName': 'Cigdem', 'Initials': 'C', 'LastName': 'Emirza', 'Affiliation': 'Division of Physiotherapy and Rehabilitation, Institute of Graduate Studies, Istanbul University-Cerrahpaşa, Istanbul, Turkey.'}, {'ForeName': 'Goksen Kuran', 'Initials': 'GK', 'LastName': 'Aslan', 'Affiliation': 'Division of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Istanbul University-Cerrahpasa, Istanbul, Turkey.'}, {'ForeName': 'Ayse Ayzit', 'Initials': 'AA', 'LastName': 'Kilinc', 'Affiliation': 'Department of Pediatric Pulmonology, Cerrahpasa Faculty of Medicine, Istanbul University-Cerrahpasa, Istanbul, Turkey.'}, {'ForeName': 'Haluk', 'Initials': 'H', 'LastName': 'Cokugras', 'Affiliation': 'Department of Pediatric Pulmonology, Cerrahpasa Faculty of Medicine, Istanbul University-Cerrahpasa, Istanbul, Turkey.'}]",Pediatric pulmonology,['10.1002/ppul.25259'] 1894,33485608,Clinical trial to evaluate pharmacokinetics and pharmacodynamics of medroxyprogesterone acetate after subcutaneous administration of Depo-Provera.,"OBJECTIVE To evaluate the pharmacokinetics and pharmacodynamics of medroxyprogesterone acetate after a single subcutaneous injection in the abdomen of 150 or 300 mg Depo-Provera and compare results to two injections of Depo-SubQ Provera 104 given 3 months apart. DESIGN Partially randomized, multicenter, parallel-group study. SETTING Research unit. PATIENT(S) Forty-two women of reproductive age with confirmed ovulatory cycle and body mass index of 18-35 kg/m 2 . INTERVENTION(S) Women received a single subcutaneous injection of 150 mg (n = 24) or 300 mg (n = 9) of Depo-Provera or two injections of Depo-SubQ Provera 104 (n = 9). MAIN OUTCOME MEASURE(S) Suppression of ovulation as measured by progesterone, serum medroxyprogesterone acetate concentrations, and estimated pharmacokinetics parameters. RESULT(S) No ovulations were observed during 7 months after a single injection of 150 or 300 mg Depo-Provera. The 150 mg group had a similar C max as observed over two injection cycles of Depo-SubQ Provera 104 and a similar 6-month trough concentration as the 3-month trough of Depo-SubQ Provera 104. CONCLUSION(S) Our pharmacodynamics and pharmacokinetics data provide proof of concept that Depo-Provera (150 mg) may be an effective contraceptive method when injected subcutaneously every 6 months, with up to a 4-week grace period for reinjections. CLINICAL TRIAL REGISTRATION NUMBER NCT02456584.",2021,"The 150 mg group had a similar C max as observed over two injection cycles of Depo-SubQ Provera 104 and a similar 6-month trough concentration as the 3-month trough of Depo-SubQ Provera 104. ",['Forty-two women of reproductive age with confirmed ovulatory cycle and body mass index of 18-35 kg/m 2 '],"['medroxyprogesterone acetate', 'Depo-Provera or two injections of Depo-SubQ Provera']","['Suppression of ovulation as measured by progesterone, serum medroxyprogesterone acetate concentrations, and estimated pharmacokinetics parameters']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}, {'cui': 'C0699700', 'cui_str': 'Depo-Provera'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1589969', 'cui_str': 'depo-subQ provera'}]","[{'cui': 'C0702239', 'cui_str': 'Suppression of ovulation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.070972,"The 150 mg group had a similar C max as observed over two injection cycles of Depo-SubQ Provera 104 and a similar 6-month trough concentration as the 3-month trough of Depo-SubQ Provera 104. ","[{'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Halpern', 'Affiliation': 'FHI 360, Durham, North Carolina. Electronic address: vhalpern@fhi360.org.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Brache', 'Affiliation': 'Profamilia, Biomedical Research Department, Santo Domingo, Dominican Republic.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Taylor', 'Affiliation': 'FHI 360, Durham, North Carolina.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Lendvay', 'Affiliation': 'FHI 360, Durham, North Carolina.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Cochón', 'Affiliation': 'Profamilia, Biomedical Research Department, Santo Domingo, Dominican Republic.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Jensen', 'Affiliation': 'Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Laneta J', 'Initials': 'LJ', 'LastName': 'Dorflinger', 'Affiliation': 'FHI 360, Durham, North Carolina.'}]",Fertility and sterility,['10.1016/j.fertnstert.2020.11.002'] 1895,33486130,Multi-Modal Analgesic Strategy for Trauma: A Pragmatic Randomized Clinical Trial.,"BACKGROUND An effective strategy to manage acute pain and minimize opioid exposure is needed for injured patients. In this trial, we aimed to compare 2 multimodal pain regimens (MMPRs) for minimizing opioid exposure and relieving acute pain in a busy, urban trauma center. METHODS This was an unblinded, pragmatic, randomized, comparative effectiveness trial of all adult trauma admissions except vulnerable patient populations and readmissions. The original MMPR (IV administration, followed by oral, acetaminophen, 48 hours of celecoxib and pregabalin, followed by naproxen and gabapentin, scheduled tramadol, and as-needed oxycodone) was compared with an MMPR of generic medications, termed the Multi-Modal Analgesic Strategies for Trauma (MAST) MMPR (ie oral acetaminophen, naproxen, gabapentin, lidocaine patches, and as-needed opioids). The primary endpoint was oral morphine milligram equivalents (MMEs) per day and secondary outcomes included total MMEs during hospitalization, opioid prescribing at discharge, and pain scores. RESULTS During the trial, 1,561 patients were randomized, 787 to receive the original MMPR and 774 to receive the MAST MMPR. There were no differences in demographic characteristics, injury characteristics, or operations performed. Patients randomized to receive the MAST MMPR had lower MMEs per day (34 MMEs/d; interquartile range 15 to 61 MMEs/d vs 48 MMEs/d; interquartile range 22 to 74 MMEs/d; p < 0.001) and fewer were prescribed opioids at discharge (62% vs 67%; p = 0.029; relative risk 0.92; 95% credible interval, 0.86 to 0.99; posterior probability relative risk <1 = 0.99). No clinically significant difference in pain scores were seen. CONCLUSIONS The MAST MMPR was a generalizable and widely available approach that reduced opioid exposure after trauma and achieved adequate acute pain control.",2021,"Patients randomized to the MAST MMPR had lower MME per day (34 MME/day, IQR [15, 61] versus 48 MME/day, IQR [22,74], p<0.001) and fewer were prescribed opioids at discharge (62% versus 67%, p=0.029; RR 0.92, 95% credible interval 0.86-0.99, posterior probability RR<1 = 0.99).","['Trauma', 'all adult trauma admissions except vulnerable patient populations and readmissions', 'injured patients', 'a busy, urban trauma center', '1,561 patients were randomized and included - 787 to the original MMPR and 774 the MAST MMPR']","['multimodal pain regimens (MMPR', 'MAST MMPR (oral acetaminophen, naproxen, gabapentin, lidocaine', 'acetaminophen', 'MAST MMPR', 'celecoxib and pregabalin followed by naproxen and gabapentin, scheduled tramadol, and as needed oxycodone']","['oral morphine milligram equivalents (MME) per day and secondary outcomes included total MME during hospitalization, opioid prescribing at discharge, and pain scores', 'pain scores']","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0282185', 'cui_str': 'Antishock wear system trousers'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0282185', 'cui_str': 'Antishock wear system trousers'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0027396', 'cui_str': 'Naproxen'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}]","[{'cui': 'C0360457', 'cui_str': 'Morphine-containing product in oral dose form'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",1561.0,0.401878,"Patients randomized to the MAST MMPR had lower MME per day (34 MME/day, IQR [15, 61] versus 48 MME/day, IQR [22,74], p<0.001) and fewer were prescribed opioids at discharge (62% versus 67%, p=0.029; RR 0.92, 95% credible interval 0.86-0.99, posterior probability RR<1 = 0.99).","[{'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Harvin', 'Affiliation': 'Center for Translational Injury Research, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX; Department of Surgery, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX; Center for Clinical Research and Evidence-Based Medicine, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX. Electronic address: John.Harvin@uth.tmc.edu.'}, {'ForeName': 'Rondel', 'Initials': 'R', 'LastName': 'Albarado', 'Affiliation': 'Department of Surgery, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Van Thi Thanh', 'Initials': 'VTT', 'LastName': 'Truong', 'Affiliation': 'Center for Clinical Research and Evidence-Based Medicine, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Green', 'Affiliation': 'Center for Clinical Research and Evidence-Based Medicine, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Jon E', 'Initials': 'JE', 'LastName': 'Tyson', 'Affiliation': 'Center for Clinical Research and Evidence-Based Medicine, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pedroza', 'Affiliation': 'Center for Clinical Research and Evidence-Based Medicine, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Wade', 'Affiliation': 'Center for Translational Injury Research, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX; Department of Surgery, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Lillian S', 'Initials': 'LS', 'LastName': 'Kao', 'Affiliation': 'Center for Translational Injury Research, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX; Department of Surgery, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX; Center for Clinical Research and Evidence-Based Medicine, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Surgeons,['10.1016/j.jamcollsurg.2020.12.014'] 1896,32270179,Vitamin D Sufficiency Has a Limited Effect on Placental Structure and Pathology: Placental Phenotypes in the VDAART Trial.,"Vitamin D insufficiency during pregnancy is widespread. The effects of active vitamin D on the human placenta in vivo are unknown. We test the hypotheses that 25(OH)D sufficiency (arbitrarily defined as 25(OH)D ≥32 ng/mL) modulates placental structure and function in vivo in a population of women whose offspring are at risk for childhood asthma, and that placental pathology is more common in offspring that evolve asthma at age 3. Pregnant volunteers in the St. Louis, MO, cohort of the Vitamin D Antenatal Asthma Reduction Trial (VDAART, NIH grant #HL091528) participated in a nested case-control study and consented for the study of placentas after delivery. Maternal concentrations of 25(OH)D were measured at trial entry and in the third trimester. The histopathology of the placentas from women with sufficient 25(OH)D, versus insufficient, showed no clinically significant differences, but morphometry revealed villi of women with sufficient third-trimester 25(OH)D had a higher villous surface density. Notably, analyses of transcripts, extracted from formalin-fixed paraffin-embedded specimens, revealed higher expression of INTS9, vWF, MACC1, and ARMS2, and diminished expression of the CNTN5 genes in the insufficient group. A larger proportion of placentas showed chronic chorioamnionitis in offspring with versus without asthma at age 3. These findings suggest that maternal 25(OH)D insufficiency has a limited effect on human placental villous histopathology and morphometry, but attenuates a small number of placental gene expression profiles in this selected population. The association of placental chronic chorioamnionitis and offspring asthma is worthy of further study.",2020,"Notably, analyses of transcripts, extracted from formalin-fixed paraffin-embedded specimens, revealed higher expression of INTS9, vWF, MACC1, and ARMS2, and diminished expression of the CNTN5 genes in the insufficient group.","['Pregnant volunteers in the St. Louis, MO, cohort of the Vitamin D Antenatal Asthma Reduction Trial (VDAART, NIH grant #HL091528) participated in a nested case-control study and consented for the study of placentas after delivery']","['active vitamin D', 'Vitamin D Sufficiency']","['villous surface density', 'expression of INTS9, vWF, MACC1, and ARMS2, and diminished expression of the CNTN5 genes', 'chronic chorioamnionitis', 'Maternal concentrations of 25(OH)D']","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0018173', 'cui_str': 'Grants'}, {'cui': 'C0007328', 'cui_str': 'Case Control Studies'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C2742157', 'cui_str': 'metastasis-associated in colon cancer 1 protein, human'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0008495', 'cui_str': 'Chorioamnionitis'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0546843,"Notably, analyses of transcripts, extracted from formalin-fixed paraffin-embedded specimens, revealed higher expression of INTS9, vWF, MACC1, and ARMS2, and diminished expression of the CNTN5 genes in the insufficient group.","[{'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'He', 'Affiliation': 'Department of Pathology & Immunology, Washington University School of Medicine in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Mirzakhani', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Harvard Medical School and Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Division of Biostatistics, Washington University School of Medicine in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wu', 'Affiliation': 'Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Augusto A', 'Initials': 'AA', 'LastName': 'Litonjua', 'Affiliation': 'Division of Pulmonary Medicine, Department of Pediatrics, University of Rochester, School of Medicine, Rochester, New York.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Bacharier', 'Affiliation': 'Division of Allergy, Immunology and Pulmonary Medicine, Department of Pediatrics, Washington University School of Medicine in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Weiss', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Harvard Medical School and Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'D Michael', 'Initials': 'DM', 'LastName': 'Nelson', 'Affiliation': 'Department of Obstetrics & Gynecology, Washington University School of Medicine in St. Louis, St. Louis, Missouri.'}]",Endocrinology,['10.1210/endocr/bqaa057'] 1897,33822479,"Effect of hepatic impairment on pharmacokinetics, safety, and tolerability of lemborexant.","Lemborexant, a dual orexin receptor antagonist, is approved in the United States, Japan, and Canada for the treatment of insomnia in adults. This phase I, multicenter, open-label, parallel-group study assessed the impact of mild or moderate hepatic impairment (HI) on lemborexant pharmacokinetics and metabolism. The pharmacokinetics, tolerability, and safety of lemborexant were evaluated in subjects with mild (Child-Pugh class A) or moderate (Child-Pugh class B) HI and healthy age-, sex-, and body mass index (BMI)-matched control subjects (n = 8 subjects/group). Subjects received a single oral dose of lemborexant 10 mg (LEM10). Blood samples were collected up to 312 hours post dosing for lemborexant pharmacokinetics assessments. Median time to maximum plasma concentration was similar across all groups. Compared with healthy subjects, exposure measures (maximum plasma concentration [C max ] and area under the curve extrapolated to infinity [AUC 0-inf ]) increased by ~58% (C max ) and ~25% (AUC 0-inf ) in subjects with mild HI and ~22% (C max ) and ~54% (AUC 0-inf ) in subjects with moderate HI. Clearance decreased by 20% and 35% in subjects with mild and moderate HI, respectively, versus healthy subjects. Lemborexant unbound fraction was similar in all groups (range: 0.060-0.065). All treatment-emergent adverse events (TEAEs) were mild in severity; no serious TEAEs occurred. In conclusion, following a single LEM10 dose, lemborexant exposure was similar in subjects with mild HI and increased in subjects with moderate HI versus healthy subjects. No dose adjustment is required in subjects with mild HI. Dosing in subjects with moderate HI should be restricted to 5 mg. Lemborexant was well tolerated in all groups.",2021,Lemborexant unbound fraction was similar in all groups (range: 0.060-0.065).,"['subjects with moderate HI', 'subjects with mild (Child-Pugh class A) or moderate (Child-Pugh class B) HI and healthy age-, sex-, and body mass index (BMI)-matched control subjects (n\xa0=\xa08 subjects/group', 'subjects with mild HI']","['lemborexant', 'lemborexant 10\xa0mg (LEM10', 'Lemborexant']","['pharmacokinetics, tolerability, and safety of lemborexant', 'Median time to maximum plasma concentration', 'exposure measures (maximum plasma concentration [C max ] and area under the curve extrapolated to infinity [AUC 0-inf ', 'pharmacokinetics, safety, and tolerability', 'Lemborexant unbound fraction', 'Clearance']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0948807', 'cui_str': 'Hepatic impairment'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C4050412', 'cui_str': 'Child-Pugh score'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",,0.0106326,Lemborexant unbound fraction was similar in all groups (range: 0.060-0.065).,"[{'ForeName': 'Satish', 'Initials': 'S', 'LastName': 'Dayal', 'Affiliation': 'Eisai Ltd., Hatfield, United Kingdom.'}, {'ForeName': 'Jagadeesh', 'Initials': 'J', 'LastName': 'Aluri', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Hall', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Gleb', 'Initials': 'G', 'LastName': 'Filippov', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Moline', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Larisa', 'Initials': 'L', 'LastName': 'Reyderman', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Ishani', 'Initials': 'I', 'LastName': 'Landry', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}]",Pharmacology research & perspectives,['10.1002/prp2.758'] 1898,33422476,Evaluation of sandblasting with acid etching versus acid etching alone in the preparation of enamel for rebonding orthodontic brackets: An in vitro study and a randomized controlled trial.,"BACKGROUND No clinical studies have evaluated shear bond strength and the clinical failure rates of the rebonded metallic brackets following different enamel-reconditioning methods. The objective of the study was to compare the in vivo clinical failure rate and the in vitro rebond strength of bonded brackets following two enamel surface preparation methods. METHODS For the in vitro study, 45 extracted human premolars were etched; brackets were bonded using light-cured composite resin. Forty-five premolars were divided into three groups (15 in each group): the initial bonding group (IB group), the rebonding group in which enamel was reconditioned using sandblasting before acid etching (SBE group), and the rebonding group in which enamel was reconditioned using acid etching only (E group). For the in vivo study, 80 premolars in 20 patients (13-18 years old) were rebonded using the same procedures in the SBE group and E group. The two methods were used in all patients using a split-mouth design. The number of failing brackets was quantified over 6 months. Differences were statistically analyzed by one-way analysis of variance, followed by post hoc tests. RESULTS The mean shear bond strength for the IB, SBE, and E groups was 19.38, 22.37, and 17.31 MPa, respectively. A significant difference was observed in the bond strength of the three evaluated groups (P < 0.001). The differences in the bond strength were significant between the IB group and the SBE group, as well as between the SBE group and the E group. The clinical failure rate for bonded brackets was 10% in the SBE group, and 25% in the E group and this difference was statistically significant (P < 0.001). CONCLUSIONS Reconditioning of enamel surfaces using both intraoral air abrasion and etching in the rebonding process led to higher rebond strength than using acid etching alone and even higher than the initial brackets bonding. This trial was retrospectively registered at ClinicalTrials.gov (ID: NCT04606043).",2021,"The clinical failure rate for bonded brackets was 10% in the SBE group, and 25% in the E group and this difference was statistically significant (P < 0.001). ","['80 premolars in 20 patients (13-18\xa0years old', '45 extracted human premolars were etched; brackets were bonded using light-cured composite resin', 'Forty-five premolars', 'rebonding orthodontic brackets']","['SBE', 'initial bonding group (IB group), the rebonding group in which enamel was reconditioned using sandblasting before acid etching (SBE group), and the rebonding group in which enamel was reconditioned using acid etching only (E group', 'acid etching versus acid etching alone']","['bond strength', 'mean shear bond strength', 'number of failing brackets', 'clinical failure rate']","[{'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0085428', 'cui_str': 'Orthodontic bracket'}]","[{'cui': 'C0014122', 'cui_str': 'Subacute bacterial endocarditis'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0001128', 'cui_str': 'Acid'}]","[{'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",80.0,0.102217,"The clinical failure rate for bonded brackets was 10% in the SBE group, and 25% in the E group and this difference was statistically significant (P < 0.001). ","[{'ForeName': 'Ahmad Rami', 'Initials': 'AR', 'LastName': 'Dirie', 'Affiliation': 'Specialist and Clinical Lecturer, Department of Orthodontics, University of Aleppo Dental School, Aleppo, Syria.'}, {'ForeName': 'Mohammad Y', 'Initials': 'MY', 'LastName': 'Hajeer', 'Affiliation': 'Professor of Orthodontics, Department of Orthodontics, University of Damascus Dental School, Damascus, Syria. Electronic address: myhajeer@gmail.com.'}, {'ForeName': 'Jamal', 'Initials': 'J', 'LastName': 'Dabbas', 'Affiliation': 'Professor of Orthodontics, Department of Orthodontics, University of Aleppo Dental School, Aleppo, Syria.'}, {'ForeName': 'Heba M', 'Initials': 'HM', 'LastName': 'Al-Ibrahim', 'Affiliation': 'MSc Student at the Department of Orthodontics, University of Damascus Dental School, Damascus, Syria.'}]",Journal of the World federation of orthodontists,['10.1016/j.ejwf.2020.12.001'] 1899,33427896,Bernese peri-acetabular osteotomy performed with navigation and patient-specific templates is a reproducible and safe procedure.,"PURPOSE To present a novel surgical technique for the Bernese peri-acetabular osteotomy (PAO) using electromagnetic navigation (EMN) and patient-specific templates (PST), and to evaluate it against the traditional fluoroscopic technique. METHODS We included 40 dysplastic hips. All PAOs were performed using PST and EMN. We recorded learning-related complications. For the purpose of acetabular fragment correction analysis, patients were divided into two groups. In the study group (EMN group, 30 hips), the acetabular fragment was reoriented with the help of EMN. In the control group (XR group, 10 hips), the acetabular fragment was reoriented using fluoroscopy. We compared the difference between the planned and achieved position of the acetabular fragment and outcomes between both groups. RESULTS Two major complications occurred in four PAOs in the XR group only (first ten PAOs). The average absolute difference in planned and achieved lateral centre -edge angle (LCEA) and acetabular index (AI) was 1.2° ± 1.5° and 1.1° ± 2° for the EMN and 7° ± 6.1° and 6.3° ± 6.3° for the XR group (p = 0.02; p = 0.03). The average surgery duration was 183 ± 32 minutes for the EMN and 203 ± 42 minutes for the XR group (p = 0.19). At the last follow-up, the average Harris Hip Score (HHS) value was 88 ± 12 in the EMN and 86 ± 14 in the XR group (p = 0.84). CONCLUSIONS Our study indicates that PAO performed with EMN and PST seems to be a safe and reproducible procedure with a short learning curve. Additionally, navigated reorientation of the acetabular fragment is significantly more accurate than the fluoroscopic technique.",2021,The average surgery duration was 183 ± 32 minutes for the EMN and 203 ± 42 minutes for the XR group (p = 0.19).,['40 dysplastic hips'],"['Bernese peri-acetabular osteotomy performed with navigation and patient-specific templates', 'electromagnetic navigation (EMN) and patient-specific templates (PST', 'EMN and PST']","['average surgery duration', 'average Harris Hip Score (HHS) value', 'lateral centre\xa0-edge angle (LCEA) and acetabular index (AI']","[{'cui': 'C0334044', 'cui_str': 'Dysplasia'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0186116', 'cui_str': 'Osteotomy of acetabular bone'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C4317132', 'cui_str': 'Template'}, {'cui': 'C0013838', 'cui_str': 'Electromagnetics'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0258693,The average surgery duration was 183 ± 32 minutes for the EMN and 203 ± 42 minutes for the XR group (p = 0.19).,"[{'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Mihalič', 'Affiliation': 'Valdoltra Orthopaedic Hospital, Jadranska cesta 31, 6280, Ankaran, Slovenia. rene.mihalic@ob-valdoltra.si.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brumat', 'Affiliation': 'Valdoltra Orthopaedic Hospital, Jadranska cesta 31, 6280, Ankaran, Slovenia.'}, {'ForeName': 'Rihard', 'Initials': 'R', 'LastName': 'Trebše', 'Affiliation': 'Valdoltra Orthopaedic Hospital, Jadranska cesta 31, 6280, Ankaran, Slovenia.'}]",International orthopaedics,['10.1007/s00264-020-04897-z'] 1900,33426901,Research Attitudes Questionnaire scores predict Alzheimer's disease clinical trial dropout.,"BACKGROUND Missing data are a notable problem in Alzheimer's disease clinical trials. One cause of missing data is participant dropout. The Research Attitudes Questionnaire is a 7-item instrument that measures an individual's attitudes toward biomedical research, with higher scores indicating more favorable attitudes. The objective of this study was to describe the performance of the Research Attitudes Questionnaire over time and to examine whether Research Attitudes Questionnaire scores predict study dropout and other participant behaviors that affect trial integrity. METHODS The Research Attitudes Questionnaire was collected at baseline and weeks 26 and 52 from each member of 119 participant/study partner dyads enrolled in a Phase 2, randomized, double-blind, placebo-controlled mild-to-moderate Alzheimer's disease clinical trial. Within-subject longitudinal analyses examined change in Research Attitudes Questionnaire scores over time in each population. Logistic regression analyses that controlled for trial arm and clustering in trial sites were used to assess whether baseline Research Attitudes Questionnaire scores predicted trial completion, study medication compliance, and enrollment in optional substudies. RESULTS Participants and study partners endorsed statistically similar ratings on the Research Attitudes Questionnaire that were stable over time. Participants with baseline Research Attitudes Questionnaire scores above 28.5 were 4.7 (95% confidence interval = 1.01 to 21.95) times as likely to complete the trial compared to those with lower scores. Applying the same cutoff, baseline study partner Research Attitudes Questionnaire scores were similarly able to predict study completion (odds ratio = 4.2, 95% confidence interval = 1.71 to 10.32). Using a score cutoff of 27.5, higher participant Research Attitudes Questionnaire scores predicted study medication compliance (odds ratio = 5.85, 95% confidence interval = 1.34 to 25.54). No relationship was observed between Research Attitudes Questionnaire score and participation in optional substudies. CONCLUSION This brief instrument that measures research attitudes may identify participants at risk for behaviors that cause missing data.",2021,"Using a score cutoff of 27.5, higher participant Research Attitudes Questionnaire scores predicted study medication compliance (odds ratio = 5.85, 95% confidence interval = 1.34 to 25.54).","[""controlled mild-to-moderate Alzheimer's disease clinical trial""]",['placebo'],"['Attitudes Questionnaire scores', 'Research Attitudes Questionnaire scores', 'Research Attitudes Questionnaire']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]",,0.0889511,"Using a score cutoff of 27.5, higher participant Research Attitudes Questionnaire scores predicted study medication compliance (odds ratio = 5.85, 95% confidence interval = 1.34 to 25.54).","[{'ForeName': 'Shana D', 'Initials': 'SD', 'LastName': 'Stites', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'R Scott', 'Initials': 'RS', 'LastName': 'Turner', 'Affiliation': 'Department of Neurology, Georgetown University, Washington, DC, USA.'}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'Gill', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Gurian', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Karlawish', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Grill', 'Affiliation': 'Departments of Psychiatry and Human Behavior and Neurobiology and Behavior, Institute for Memory Impairments and Neurological Disorders, University of California, Irvine, Irvine, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Clinical trials (London, England)",['10.1177/1740774520982315'] 1901,33431344,Investigating IGF-II and IGF2R serum markers as predictors of body weight loss following an 8-week acute weight loss intervention: PREVIEW sub-study.,"BACKGROUND Weight reduction is effective in preventing T2D however, weight reduction and maintenance is difficult to achieve on a population scale. Serum insulin-like growth factor II (IGF-II) and IGF-II receptor (IGF2R) have been associated with diabetic status and body weight in prior studies and, in addition, IGF-II has been indicated as predictive of future weight change. We measured these serum markers in participants with obesity/overweight and prediabetes from the New Zealand arm of the PREVIEW lifestyle intervention randomised trial before and after an 8-week low energy diet (LED). METHODS Total IGF-II (n = 223) and soluble IGF2R (n = 151) were measured using commercial ELISA kits on fasted serum samples taken prior to an 8-week LED and also from participants completing the LED. RESULTS IGF-II levels were not correlated with baseline body weight although mean levels did significantly decrease following the LED. Change in IGF-II serum level was correlated to fasting glucose change (p = 0.04) but not to weight change. Baseline serum IGF2R was correlated with BMI (p = 0.007) and was significantly higher in Māori compared to European Caucasian participants independent of body weight (p = 0.0016). Following LED, IGF2R change was positively associated with weight change (p = 0.02) when corrected for ethnicity. Pre-LED levels of these serum markers were not predictive of the magnitude of weight loss over the 8 weeks. CONCLUSION Neither marker was useful in predicting magnitude of short-term weight loss. IGF2R is positively associated with BMI and is higher in Māori compared to European Caucasian individuals.",2021,Baseline serum IGF2R was correlated with BMI (p = 0.007) and was significantly higher in Māori compared to European Caucasian participants independent of body weight (p = 0.0016).,"['participants with obesity/overweight and prediabetes from the New Zealand arm of the PREVIEW lifestyle intervention randomised trial before and after an 8-week', 'Total IGF-II (n = 223) and soluble IGF2R']","['low energy diet (LED', 'commercial ELISA kits']","['fasting glucose change', 'weight loss', 'IGF2R change', 'weight change', 'Serum insulin-like growth factor II (IGF-II) and IGF-II receptor (IGF2R', 'Change in IGF-II serum level', 'Baseline serum IGF2R']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021666', 'cui_str': 'insulin-like growth factor 2'}, {'cui': 'C1334189', 'cui_str': 'IGF2R protein, human'}]","[{'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1334189', 'cui_str': 'IGF2R protein, human'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0021666', 'cui_str': 'insulin-like growth factor 2'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",151.0,0.026481,Baseline serum IGF2R was correlated with BMI (p = 0.007) and was significantly higher in Māori compared to European Caucasian participants independent of body weight (p = 0.0016).,"[{'ForeName': 'Kate L', 'Initials': 'KL', 'LastName': 'Lee', 'Affiliation': 'Department of Molecular Medicine and Pathology, Faculty of Medical and Health Sciences, The University of Auckland, Private Bag 92019, Auckland 1142, New Zealand; Maurice Wilkins Centre for Molecular Biodiscovery, The University of Auckland, Private Bag 92019, Auckland 1142, New Zealand. Electronic address: kathryn.lee@auckland.ac.nz.'}, {'ForeName': 'Marta P', 'Initials': 'MP', 'LastName': 'Silvestre', 'Affiliation': 'Human Nutrition Unit, The University of Auckland, Private Bag 92019, Auckland 1142, New Zealand; School of Biological Sciences, The University of Auckland, Private Bag 92019, Auckland 1142, New Zealand; CINTESIS - Centro de Investigação em Tecnologias e Serviços de Saúde | NOVA Medical School, NOVA University of Lisbon, 1169-056 Lisboa, Portugal.'}, {'ForeName': 'Nour H', 'Initials': 'NH', 'LastName': 'AlSaud', 'Affiliation': 'Human Nutrition Unit, The University of Auckland, Private Bag 92019, Auckland 1142, New Zealand.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Fogelholm', 'Affiliation': 'Department of Food and Environmental Sciences, University of Helsinki, 00014 Helsinki, Finland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Raben', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Rolighedsvej 30, Frederiksberg C, DK-1958 Copenhagen, Denmark.'}, {'ForeName': 'Sally D', 'Initials': 'SD', 'LastName': 'Poppitt', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, The University of Auckland, Private Bag 92019, Auckland 1142, New Zealand; Human Nutrition Unit, The University of Auckland, Private Bag 92019, Auckland 1142, New Zealand; School of Biological Sciences, The University of Auckland, Private Bag 92019, Auckland 1142, New Zealand.'}]",Obesity research & clinical practice,['10.1016/j.orcp.2020.12.007'] 1902,33434704,"Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) study: Rationale, design and baseline characteristics of a randomized control trial of the MIND diet on cognitive decline.","Alzheimer's dementia (AD) is the sixth leading cause of death in the U.S., with an estimated $305 billion cost of care in 2020. Currently there are no cures or therapies to ameliorate the disease progression and symptoms. Growing evidence links a diet characterized by high antioxidant components with benefits to cognitive function, which is indicative of the preventative potential of dietary inteventions. The Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) study is a 3-year, multicenter, randomized controlled trial to test the effects of the MIND diet on cognitive function in 604 individuals at risk for AD. Men and women ages 65 to 84 years were recruited. Eligible participants were randomized to either the MIND diet with mild caloric restriction or their usual diet with mild caloric restriction. Cognitive assessments, medical history, blood pressure, anthropometric measurements, and blood and urine sample collections will be taken at baseline and follow-up visits. MRI scans will be completed on approximately half of the enrolled participants at the start and end of the study. Unique features of the MIND study include: 1) a dietary pattern, rather than single nutrient or food, tested in an at-risk population; 2) foods featured as key components of the MIND diet (i.e. extra-virgin olive oil, blueberries, and nuts) provided for participants; and 3) MRI scans of brain structure and volume that may provide potential mechanistic evidence on the effects of the diet. Results from the study will be crucial to the development of dietary guidelines for the prevention of AD.",2021,Eligible participants were randomized to either the MIND diet with mild caloric restriction or their usual diet with mild caloric restriction.,"[""Alzheimer's dementia (AD"", '604 individuals at risk for AD', 'Men and women ages 65 to 84\u202fyears were recruited', 'Eligible participants']","['Mediterranean-DASH intervention', 'Mediterranean-DASH Intervention', 'MIND diet with mild caloric restriction or their usual diet with mild caloric restriction', 'MIND diet']","['cognitive decline', 'Cognitive assessments, medical history, blood pressure, anthropometric measurements, and blood and urine sample collections', 'cognitive function']","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.0810864,Eligible participants were randomized to either the MIND diet with mild caloric restriction or their usual diet with mild caloric restriction.,"[{'ForeName': 'Xiaoran', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Rush Institute for Healthy Aging, Rush University Medical Center, Chicago, IL, United States of America; Department of Internal Medicine, Rush University Medical Center, Chicago, IL, United States of America.'}, {'ForeName': 'Martha Clare', 'Initials': 'MC', 'LastName': 'Morris', 'Affiliation': 'Rush Institute for Healthy Aging, Rush University Medical Center, Chicago, IL, United States of America; Department of Internal Medicine, Rush University Medical Center, Chicago, IL, United States of America.'}, {'ForeName': 'Klodian', 'Initials': 'K', 'LastName': 'Dhana', 'Affiliation': 'Rush Institute for Healthy Aging, Rush University Medical Center, Chicago, IL, United States of America; Department of Internal Medicine, Rush University Medical Center, Chicago, IL, United States of America.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Ventrelle', 'Affiliation': 'Department of Preventive Medicine, Rush Medical College, Chicago, IL, United States of America.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Johnson', 'Affiliation': ""Department of Nutrition, Harvard School of Public Health, Boston, MA, United States of America; Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Bishop', 'Affiliation': ""Department of Nutrition, Harvard School of Public Health, Boston, MA, United States of America; Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Chiquia S', 'Initials': 'CS', 'LastName': 'Hollings', 'Affiliation': 'Rush Institute for Healthy Aging, Rush University Medical Center, Chicago, IL, United States of America; Department of Internal Medicine, Rush University Medical Center, Chicago, IL, United States of America.'}, {'ForeName': 'Adrianna', 'Initials': 'A', 'LastName': 'Boulin', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Laranjo', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Stubbs', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Reilly', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Carey', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America.""}, {'ForeName': 'Yamin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Rush Institute for Healthy Aging, Rush University Medical Center, Chicago, IL, United States of America; Department of Internal Medicine, Rush University Medical Center, Chicago, IL, United States of America.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Furtado', 'Affiliation': 'Department of Nutrition, Harvard School of Public Health, Boston, MA, United States of America.'}, {'ForeName': 'Santica M', 'Initials': 'SM', 'LastName': 'Marcovina', 'Affiliation': 'Northwest Lipid Metabolism and Diabetes Research Laboratories, Seattle, WA, United States of America.'}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Tangney', 'Affiliation': 'Department of Preventive Medicine, Rush Medical College, Chicago, IL, United States of America; Department of Clinical Nutrition, Rush Medical College, Chicago, IL, United States of America.'}, {'ForeName': 'Neelum T', 'Initials': 'NT', 'LastName': 'Aggarwal', 'Affiliation': ""Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago, IL, United States of America; Department of Neurology, Rush University Medical Center, Chicago, IL, United States of America.""}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Arfanakis', 'Affiliation': ""Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago, IL, United States of America; Department of Diagnostic Radiology and Nuclear Medicine, Rush University Medical Center, Chicago, IL, United States of America; Department of Biomedical Engineering, Illinois Institute of Technology, Chicago, IL, United States of America.""}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Sacks', 'Affiliation': 'Department of Nutrition, Harvard School of Public Health, Boston, MA, United States of America.'}, {'ForeName': 'Lisa L', 'Initials': 'LL', 'LastName': 'Barnes', 'Affiliation': ""Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago, IL, United States of America; Department of Neurology, Rush University Medical Center, Chicago, IL, United States of America. Electronic address: Lisa_L_Barnes@rush.edu.""}]",Contemporary clinical trials,['10.1016/j.cct.2021.106270'] 1903,33434629,"""It's the single best thing I've done in the last 10 years"": a qualitative study exploring patient and dietitian experiences with, and perceptions of, a multi-component dietary weight loss program for knee osteoarthritis.","OBJECTIVE Explore patient and dietitian experiences with a multi-component dietary weight loss program for knee osteoarthritis to understand enablers and challenges to success at 6-months. DESIGN Qualitative study embedded within a randomised controlled trial. Semi-structured individual interviews with 24 patients with knee osteoarthritis who undertook, and five dietitians who supervised, a weight management program (involving a ketogenic very low calorie diet (VLCD), video consultations, educational resources) over 6 months. Data were thematically analysed. RESULTS Five themes were developed: (1) ease and convenience of program facilitated adherence (structure and simplicity of the meal replacements; not feeling hungry on diet; convenience of consulting via video) (2) social and professional support crucial for success (encouragement from partner, family, and friends; guidance from, and accountability to, dietitian; anxiety around going at it alone) (3) program was engaging and motivating (determination to stick to program; rapid weight loss helped motivation) (4) holistic nature of program was important (suite of high-quality educational resources; exercise important to compliment weight loss) (5) rewarding experience and lifelong impact (improved knee pain and function; positive lifestyle change). CONCLUSIONS Patients and dietitians described positive experiences with the weight management program, valuing its simplicity, effectiveness, and convenience. Support from dietitians and a comprehensive suite of educational resources, incorporated with an exercise program, were considered crucial for success. Findings suggest this multi-component dietary program is an acceptable weight loss method in people with knee osteoarthritis that may benefit symptoms. Strategies for supporting long-term independent weight management should be a focus of future research.",2021,"RESULTS Five themes were developed: i) ease and convenience of program facilitated adherence (structure and simplicity of the meal replacements; not feeling hungry on diet; convenience of consulting via video) ii) social and professional support crucial for success (encouragement from partner, family, and friends; guidance from, and accountability to, dietitian; anxiety around going at it alone) iii) program was engaging and motivating (determination to stick to program; rapid weight loss helped motivation)","['24 patients with knee osteoarthritis who undertook, and five dietitians who supervised, a', 'people with knee osteoarthritis']","['multi-component dietary weight loss program', 'weight management program (involving a ketogenic very low calorie diet (VLCD), video consultations, educational resources']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0452268', 'cui_str': 'Very low energy diet'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]",[],24.0,0.0216152,"RESULTS Five themes were developed: i) ease and convenience of program facilitated adherence (structure and simplicity of the meal replacements; not feeling hungry on diet; convenience of consulting via video) ii) social and professional support crucial for success (encouragement from partner, family, and friends; guidance from, and accountability to, dietitian; anxiety around going at it alone) iii) program was engaging and motivating (determination to stick to program; rapid weight loss helped motivation)","[{'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Lawford', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, The University of Melbourne, Victoria, Australia. Electronic address: belinda.lawford@unimelb.edu.au.'}, {'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'Bennell', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, The University of Melbourne, Victoria, Australia. Electronic address: k.bennell@unimelb.edu.au.'}, {'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'Jones', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, The University of Melbourne, Victoria, Australia. Electronic address: jones.s@unimelb.edu.au.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Keating', 'Affiliation': 'Medibank Private, Melbourne, Vic, Australia. Electronic address: Catherine.Keating@medibank.com.au.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Brown', 'Affiliation': 'Medibank Private, Melbourne, Vic, Australia. Electronic address: Courtney.Brown@medibank.com.au.'}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Hinman', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, The University of Melbourne, Victoria, Australia. Electronic address: ranash@unimelb.edu.au.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2021.01.001'] 1904,33434610,Effect of oxytocin on lipid accumulation under inflammatory conditions in human macrophages.,"INTRODUCTION AND AIMS Oxytocin (OT) is a neuropeptide hormone secreted by the posterior pituitary gland. Deficits in OT action have been observed in patients with behavioral and mood disorders, some of which correlate with an increased risk of cardiovascular disease (CVD). Recent research has revealed a wider systemic role that OT plays in inflammatory modulation and development of atherosclerotic plaques. This study investigated the role that OT plays in cholesterol transport and foam cell formation in LPS-stimulated THP-1 human macrophages. METHODS THP-1 differentiated macrophages were treated with media, LPS (100 ng/ml), LPS + OT (10 pM), or LPS + OT (100 pM). Changes in gene expression and protein levels of cholesterol transporters were analyzed by real time quantitative PCR (RT-qPCR) and Western blot, while oxLDL uptake and cholesterol efflux capacity were evaluated with fluorometric assays. RESULTS RT-qPCR analysis revealed a significant increase in ABCG1 gene expression upon OT + LPS treatment, compared to LPS alone (p = 0.0081), with Western blotting supporting the increase in expression of the ABCG1 protein. Analysis of oxLDL uptake showed a significantly lower fluorescent value in LPS + OT (100pM) -treated cells when compared to LPS alone (p < 0.0001). While not statistically significant (p = 0.06), cholesterol efflux capacity increased with LPS + OT treatment. CONCLUSION We demonstrate here that OT can attenuate LPS-mediated lipid accumulation in THP-1 macrophages. These findings support the hypothesis that OT could be used to reduce pro-inflammatory and potentially atherogenic changes observed in patients with heightened CVD risk. This study suggests further exploration of OT effects on monocyte and macrophage cholesterol handling in vivo.",2021,"RESULTS RT-qPCR analysis revealed a significant increase in ABCG1 gene expression upon OT + LPS treatment, compared to LPS alone (p = 0.0081), with Western blotting supporting the increase in expression of the ABCG1 protein.","['patients with heightened CVD risk', 'THP-1 differentiated macrophages were treated with', 'patients with behavioral and mood disorders', 'human macrophages']","['media, LPS', 'OT', 'oxytocin', 'Oxytocin (OT', 'LPS\xa0+\xa0OT (10 pM), or LPS\xa0+\xa0OT']","['ABCG1 gene expression', 'real time quantitative PCR (RT-qPCR) and Western blot, while oxLDL uptake and cholesterol efflux capacity', 'expression of the ABCG1 protein', 'gene expression and protein levels of cholesterol transporters', 'OT (100pM) -treated cells', 'cholesterol efflux capacity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442803', 'cui_str': 'Heightened'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0071126', 'cui_str': 'Pirarubicin'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0525045', 'cui_str': 'Mood disorder'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0963751', 'cui_str': 'ABCG1 protein, human'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0005863', 'cui_str': 'Western Blotting'}, {'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C4255014', 'cui_str': 'ATP Binding Cassette Transporter, Sub-Family G, Member 1'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}, {'cui': 'C0596902', 'cui_str': 'Membrane Transporters'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]",,0.0251457,"RESULTS RT-qPCR analysis revealed a significant increase in ABCG1 gene expression upon OT + LPS treatment, compared to LPS alone (p = 0.0081), with Western blotting supporting the increase in expression of the ABCG1 protein.","[{'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Karten', 'Affiliation': 'NYU Langone Hospital - Long Island Biomedical Research Institute and NYU Long Island School of Medicine, Mineola, New York, United States of America.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Vernice', 'Affiliation': 'NYU Langone Hospital - Long Island Biomedical Research Institute and NYU Long Island School of Medicine, Mineola, New York, United States of America.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Renna', 'Affiliation': 'NYU Langone Hospital - Long Island Biomedical Research Institute and NYU Long Island School of Medicine, Mineola, New York, United States of America.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Carsons', 'Affiliation': 'NYU Langone Hospital - Long Island Biomedical Research Institute and NYU Long Island School of Medicine, Mineola, New York, United States of America.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'DeLeon', 'Affiliation': 'NYU Langone Hospital - Long Island Biomedical Research Institute and NYU Long Island School of Medicine, Mineola, New York, United States of America.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Pinkhasov', 'Affiliation': 'NYU Langone Hospital - Long Island Biomedical Research Institute and NYU Long Island School of Medicine, Mineola, New York, United States of America.'}, {'ForeName': 'Irving H', 'Initials': 'IH', 'LastName': 'Gomolin', 'Affiliation': 'NYU Langone Hospital - Long Island Biomedical Research Institute and NYU Long Island School of Medicine, Mineola, New York, United States of America.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Glass', 'Affiliation': 'NYU Langone Hospital - Long Island Biomedical Research Institute and NYU Long Island School of Medicine, Mineola, New York, United States of America.'}, {'ForeName': 'Allison B', 'Initials': 'AB', 'LastName': 'Reiss', 'Affiliation': 'NYU Langone Hospital - Long Island Biomedical Research Institute and NYU Long Island School of Medicine, Mineola, New York, United States of America.'}, {'ForeName': 'Lora J', 'Initials': 'LJ', 'LastName': 'Kasselman', 'Affiliation': 'NYU Langone Hospital - Long Island Biomedical Research Institute and NYU Long Island School of Medicine, Mineola, New York, United States of America. Electronic address: lora.kasselman@nyulangone.org.'}]",Experimental and molecular pathology,['10.1016/j.yexmp.2021.104604'] 1905,33382931,Higher or Lower Hemoglobin Transfusion Thresholds for Preterm Infants.,"BACKGROUND Limited data suggest that higher hemoglobin thresholds for red-cell transfusions may reduce the risk of cognitive delay among extremely-low-birth-weight infants with anemia. METHODS We performed an open, multicenter trial in which infants with a birth weight of 1000 g or less and a gestational age between 22 weeks 0 days and 28 weeks 6 days were randomly assigned within 48 hours after delivery to receive red-cell transfusions at higher or lower hemoglobin thresholds until 36 weeks of postmenstrual age or discharge, whichever occurred first. The primary outcome was a composite of death or neurodevelopmental impairment (cognitive delay, cerebral palsy, or hearing or vision loss) at 22 to 26 months of age, corrected for prematurity. RESULTS A total of 1824 infants (mean birth weight, 756 g; mean gestational age, 25.9 weeks) underwent randomization. There was a between-group difference of 1.9 g per deciliter (19 g per liter) in the pretransfusion mean hemoglobin levels throughout the treatment period. Primary outcome data were available for 1692 infants (92.8%). Of 845 infants in the higher-threshold group, 423 (50.1%) died or survived with neurodevelopmental impairment, as compared with 422 of 847 infants (49.8%) in the lower-threshold group (relative risk adjusted for birth-weight stratum and center, 1.00; 95% confidence interval [CI], 0.92 to 1.10; P = 0.93). At 2 years, the higher- and lower-threshold groups had similar incidences of death (16.2% and 15.0%, respectively) and neurodevelopmental impairment (39.6% and 40.3%, respectively). At discharge from the hospital, the incidences of survival without severe complications were 28.5% and 30.9%, respectively. Serious adverse events occurred in 22.7% and 21.7%, respectively. CONCLUSIONS In extremely-low-birth-weight infants, a higher hemoglobin threshold for red-cell transfusion did not improve survival without neurodevelopmental impairment at 22 to 26 months of age, corrected for prematurity. (Funded by the National Heart, Lung, and Blood Institute and others; TOP ClinicalTrials.gov number, NCT01702805.).",2020,"In extremely-low-birth-weight infants, a higher hemoglobin threshold for red-cell transfusion did not improve survival without neurodevelopmental impairment at 22 to 26 months of age, corrected for prematurity.","['Preterm Infants', 'infants with a birth weight of 1000 g or less and a gestational age between 22 weeks 0 days and 28 weeks 6 days', '1824 infants (mean birth weight, 756 g; mean gestational age, 25.9 weeks) underwent randomization']",[],"['pretransfusion mean hemoglobin levels', 'survival without neurodevelopmental impairment', 'survival without severe complications', 'Serious adverse events', 'composite of death or neurodevelopmental impairment (cognitive delay, cerebral palsy, or hearing or vision loss', 'neurodevelopmental impairment', 'death', 'died or survived with neurodevelopmental impairment']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}]",1824.0,0.421017,"In extremely-low-birth-weight infants, a higher hemoglobin threshold for red-cell transfusion did not improve survival without neurodevelopmental impairment at 22 to 26 months of age, corrected for prematurity.","[{'ForeName': 'Haresh', 'Initials': 'H', 'LastName': 'Kirpalani', 'Affiliation': ""From the Department of Pediatrics, University of Pennsylvania, and Children's Hospital of Philadelphia, Philadelphia (H.K., B.S., A.S.C.); the Department of Pediatrics, University of Iowa, Iowa City (E.F.B., K.J.J., J.A.W.); the Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto (S.R.H., V.Y.C.), and the Department of Pediatrics, University of California, Los Angeles, Los Angeles (U.D.) - both in California; the Biostatistics and Epidemiology Division, RTI International, Research Triangle Park (S.T., M.M.C.), and the Department of Pediatrics, Duke University School of Medicine, Durham (C.M.C.) - both in North Carolina; the Biostatistics and Epidemiology Division, RTI International, Rockville (J.E.N., A.D.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda (R.D.H.) - both in Maryland; the Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI (B.R.V., A.R.L.); the Division of Neonatology, University of Alabama at Birmingham, Birmingham (W.A.C.); the University of Rochester School of Medicine and Dentistry, Rochester, NY (C.T.D., M.F.C.); the Department of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston (K.A.K.), and the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (M.H.W.); the University of New Mexico Health Sciences Center, Albuquerque (R.K.O.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (R.K.O., B.A.Y.); the Department of Pediatrics, Indiana University School of Medicine, Indianapolis (B.B.P., G.M.S.); Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (B.B.P., K.S.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W.), and Nationwide Children's Hospital and the Department of Pediatrics, Ohio State University College of Medicine, Columbus (R.S.); the Department of Pediatrics, Dalhousie University, Halifax, NS, Canada (R.K.W.); the Department of Neonatology, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston (J.A.F.Z.); the Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO (W.E.T.); Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (R.M.P.); the Department of Pediatrics, Wayne State University, Detroit (S.C.); and the College of Health and Human Services, George Mason University, Fairfax, VA (R.D.H.).""}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'Bell', 'Affiliation': ""From the Department of Pediatrics, University of Pennsylvania, and Children's Hospital of Philadelphia, Philadelphia (H.K., B.S., A.S.C.); the Department of Pediatrics, University of Iowa, Iowa City (E.F.B., K.J.J., J.A.W.); the Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto (S.R.H., V.Y.C.), and the Department of Pediatrics, University of California, Los Angeles, Los Angeles (U.D.) - both in California; the Biostatistics and Epidemiology Division, RTI International, Research Triangle Park (S.T., M.M.C.), and the Department of Pediatrics, Duke University School of Medicine, Durham (C.M.C.) - both in North Carolina; the Biostatistics and Epidemiology Division, RTI International, Rockville (J.E.N., A.D.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda (R.D.H.) - both in Maryland; the Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI (B.R.V., A.R.L.); the Division of Neonatology, University of Alabama at Birmingham, Birmingham (W.A.C.); the University of Rochester School of Medicine and Dentistry, Rochester, NY (C.T.D., M.F.C.); the Department of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston (K.A.K.), and the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (M.H.W.); the University of New Mexico Health Sciences Center, Albuquerque (R.K.O.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (R.K.O., B.A.Y.); the Department of Pediatrics, Indiana University School of Medicine, Indianapolis (B.B.P., G.M.S.); Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (B.B.P., K.S.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W.), and Nationwide Children's Hospital and the Department of Pediatrics, Ohio State University College of Medicine, Columbus (R.S.); the Department of Pediatrics, Dalhousie University, Halifax, NS, Canada (R.K.W.); the Department of Neonatology, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston (J.A.F.Z.); the Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO (W.E.T.); Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (R.M.P.); the Department of Pediatrics, Wayne State University, Detroit (S.C.); and the College of Health and Human Services, George Mason University, Fairfax, VA (R.D.H.).""}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Hintz', 'Affiliation': ""From the Department of Pediatrics, University of Pennsylvania, and Children's Hospital of Philadelphia, Philadelphia (H.K., B.S., A.S.C.); the Department of Pediatrics, University of Iowa, Iowa City (E.F.B., K.J.J., J.A.W.); the Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto (S.R.H., V.Y.C.), and the Department of Pediatrics, University of California, Los Angeles, Los Angeles (U.D.) - both in California; the Biostatistics and Epidemiology Division, RTI International, Research Triangle Park (S.T., M.M.C.), and the Department of Pediatrics, Duke University School of Medicine, Durham (C.M.C.) - both in North Carolina; the Biostatistics and Epidemiology Division, RTI International, Rockville (J.E.N., A.D.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda (R.D.H.) - both in Maryland; the Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI (B.R.V., A.R.L.); the Division of Neonatology, University of Alabama at Birmingham, Birmingham (W.A.C.); the University of Rochester School of Medicine and Dentistry, Rochester, NY (C.T.D., M.F.C.); the Department of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston (K.A.K.), and the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (M.H.W.); the University of New Mexico Health Sciences Center, Albuquerque (R.K.O.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (R.K.O., B.A.Y.); the Department of Pediatrics, Indiana University School of Medicine, Indianapolis (B.B.P., G.M.S.); Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (B.B.P., K.S.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W.), and Nationwide Children's Hospital and the Department of Pediatrics, Ohio State University College of Medicine, Columbus (R.S.); the Department of Pediatrics, Dalhousie University, Halifax, NS, Canada (R.K.W.); the Department of Neonatology, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston (J.A.F.Z.); the Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO (W.E.T.); Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (R.M.P.); the Department of Pediatrics, Wayne State University, Detroit (S.C.); and the College of Health and Human Services, George Mason University, Fairfax, VA (R.D.H.).""}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Tan', 'Affiliation': ""From the Department of Pediatrics, University of Pennsylvania, and Children's Hospital of Philadelphia, Philadelphia (H.K., B.S., A.S.C.); the Department of Pediatrics, University of Iowa, Iowa City (E.F.B., K.J.J., J.A.W.); the Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto (S.R.H., V.Y.C.), and the Department of Pediatrics, University of California, Los Angeles, Los Angeles (U.D.) - both in California; the Biostatistics and Epidemiology Division, RTI International, Research Triangle Park (S.T., M.M.C.), and the Department of Pediatrics, Duke University School of Medicine, Durham (C.M.C.) - both in North Carolina; the Biostatistics and Epidemiology Division, RTI International, Rockville (J.E.N., A.D.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda (R.D.H.) - both in Maryland; the Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI (B.R.V., A.R.L.); the Division of Neonatology, University of Alabama at Birmingham, Birmingham (W.A.C.); the University of Rochester School of Medicine and Dentistry, Rochester, NY (C.T.D., M.F.C.); the Department of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston (K.A.K.), and the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (M.H.W.); the University of New Mexico Health Sciences Center, Albuquerque (R.K.O.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (R.K.O., B.A.Y.); the Department of Pediatrics, Indiana University School of Medicine, Indianapolis (B.B.P., G.M.S.); Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (B.B.P., K.S.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W.), and Nationwide Children's Hospital and the Department of Pediatrics, Ohio State University College of Medicine, Columbus (R.S.); the Department of Pediatrics, Dalhousie University, Halifax, NS, Canada (R.K.W.); the Department of Neonatology, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston (J.A.F.Z.); the Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO (W.E.T.); Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (R.M.P.); the Department of Pediatrics, Wayne State University, Detroit (S.C.); and the College of Health and Human Services, George Mason University, Fairfax, VA (R.D.H.).""}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Schmidt', 'Affiliation': ""From the Department of Pediatrics, University of Pennsylvania, and Children's Hospital of Philadelphia, Philadelphia (H.K., B.S., A.S.C.); the Department of Pediatrics, University of Iowa, Iowa City (E.F.B., K.J.J., J.A.W.); the Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto (S.R.H., V.Y.C.), and the Department of Pediatrics, University of California, Los Angeles, Los Angeles (U.D.) - both in California; the Biostatistics and Epidemiology Division, RTI International, Research Triangle Park (S.T., M.M.C.), and the Department of Pediatrics, Duke University School of Medicine, Durham (C.M.C.) - both in North Carolina; the Biostatistics and Epidemiology Division, RTI International, Rockville (J.E.N., A.D.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda (R.D.H.) - both in Maryland; the Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI (B.R.V., A.R.L.); the Division of Neonatology, University of Alabama at Birmingham, Birmingham (W.A.C.); the University of Rochester School of Medicine and Dentistry, Rochester, NY (C.T.D., M.F.C.); the Department of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston (K.A.K.), and the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (M.H.W.); the University of New Mexico Health Sciences Center, Albuquerque (R.K.O.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (R.K.O., B.A.Y.); the Department of Pediatrics, Indiana University School of Medicine, Indianapolis (B.B.P., G.M.S.); Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (B.B.P., K.S.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W.), and Nationwide Children's Hospital and the Department of Pediatrics, Ohio State University College of Medicine, Columbus (R.S.); the Department of Pediatrics, Dalhousie University, Halifax, NS, Canada (R.K.W.); the Department of Neonatology, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston (J.A.F.Z.); the Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO (W.E.T.); Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (R.M.P.); the Department of Pediatrics, Wayne State University, Detroit (S.C.); and the College of Health and Human Services, George Mason University, Fairfax, VA (R.D.H.).""}, {'ForeName': 'Aasma S', 'Initials': 'AS', 'LastName': 'Chaudhary', 'Affiliation': ""From the Department of Pediatrics, University of Pennsylvania, and Children's Hospital of Philadelphia, Philadelphia (H.K., B.S., A.S.C.); the Department of Pediatrics, University of Iowa, Iowa City (E.F.B., K.J.J., J.A.W.); the Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto (S.R.H., V.Y.C.), and the Department of Pediatrics, University of California, Los Angeles, Los Angeles (U.D.) - both in California; the Biostatistics and Epidemiology Division, RTI International, Research Triangle Park (S.T., M.M.C.), and the Department of Pediatrics, Duke University School of Medicine, Durham (C.M.C.) - both in North Carolina; the Biostatistics and Epidemiology Division, RTI International, Rockville (J.E.N., A.D.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda (R.D.H.) - both in Maryland; the Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI (B.R.V., A.R.L.); the Division of Neonatology, University of Alabama at Birmingham, Birmingham (W.A.C.); the University of Rochester School of Medicine and Dentistry, Rochester, NY (C.T.D., M.F.C.); the Department of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston (K.A.K.), and the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (M.H.W.); the University of New Mexico Health Sciences Center, Albuquerque (R.K.O.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (R.K.O., B.A.Y.); the Department of Pediatrics, Indiana University School of Medicine, Indianapolis (B.B.P., G.M.S.); Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (B.B.P., K.S.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W.), and Nationwide Children's Hospital and the Department of Pediatrics, Ohio State University College of Medicine, Columbus (R.S.); the Department of Pediatrics, Dalhousie University, Halifax, NS, Canada (R.K.W.); the Department of Neonatology, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston (J.A.F.Z.); the Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO (W.E.T.); Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (R.M.P.); the Department of Pediatrics, Wayne State University, Detroit (S.C.); and the College of Health and Human Services, George Mason University, Fairfax, VA (R.D.H.).""}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Johnson', 'Affiliation': ""From the Department of Pediatrics, University of Pennsylvania, and Children's Hospital of Philadelphia, Philadelphia (H.K., B.S., A.S.C.); the Department of Pediatrics, University of Iowa, Iowa City (E.F.B., K.J.J., J.A.W.); the Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto (S.R.H., V.Y.C.), and the Department of Pediatrics, University of California, Los Angeles, Los Angeles (U.D.) - both in California; the Biostatistics and Epidemiology Division, RTI International, Research Triangle Park (S.T., M.M.C.), and the Department of Pediatrics, Duke University School of Medicine, Durham (C.M.C.) - both in North Carolina; the Biostatistics and Epidemiology Division, RTI International, Rockville (J.E.N., A.D.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda (R.D.H.) - both in Maryland; the Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI (B.R.V., A.R.L.); the Division of Neonatology, University of Alabama at Birmingham, Birmingham (W.A.C.); the University of Rochester School of Medicine and Dentistry, Rochester, NY (C.T.D., M.F.C.); the Department of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston (K.A.K.), and the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (M.H.W.); the University of New Mexico Health Sciences Center, Albuquerque (R.K.O.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (R.K.O., B.A.Y.); the Department of Pediatrics, Indiana University School of Medicine, Indianapolis (B.B.P., G.M.S.); Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (B.B.P., K.S.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W.), and Nationwide Children's Hospital and the Department of Pediatrics, Ohio State University College of Medicine, Columbus (R.S.); the Department of Pediatrics, Dalhousie University, Halifax, NS, Canada (R.K.W.); the Department of Neonatology, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston (J.A.F.Z.); the Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO (W.E.T.); Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (R.M.P.); the Department of Pediatrics, Wayne State University, Detroit (S.C.); and the College of Health and Human Services, George Mason University, Fairfax, VA (R.D.H.).""}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Crawford', 'Affiliation': ""From the Department of Pediatrics, University of Pennsylvania, and Children's Hospital of Philadelphia, Philadelphia (H.K., B.S., A.S.C.); the Department of Pediatrics, University of Iowa, Iowa City (E.F.B., K.J.J., J.A.W.); the Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto (S.R.H., V.Y.C.), and the Department of Pediatrics, University of California, Los Angeles, Los Angeles (U.D.) - both in California; the Biostatistics and Epidemiology Division, RTI International, Research Triangle Park (S.T., M.M.C.), and the Department of Pediatrics, Duke University School of Medicine, Durham (C.M.C.) - both in North Carolina; the Biostatistics and Epidemiology Division, RTI International, Rockville (J.E.N., A.D.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda (R.D.H.) - both in Maryland; the Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI (B.R.V., A.R.L.); the Division of Neonatology, University of Alabama at Birmingham, Birmingham (W.A.C.); the University of Rochester School of Medicine and Dentistry, Rochester, NY (C.T.D., M.F.C.); the Department of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston (K.A.K.), and the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (M.H.W.); the University of New Mexico Health Sciences Center, Albuquerque (R.K.O.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (R.K.O., B.A.Y.); the Department of Pediatrics, Indiana University School of Medicine, Indianapolis (B.B.P., G.M.S.); Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (B.B.P., K.S.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W.), and Nationwide Children's Hospital and the Department of Pediatrics, Ohio State University College of Medicine, Columbus (R.S.); the Department of Pediatrics, Dalhousie University, Halifax, NS, Canada (R.K.W.); the Department of Neonatology, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston (J.A.F.Z.); the Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO (W.E.T.); Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (R.M.P.); the Department of Pediatrics, Wayne State University, Detroit (S.C.); and the College of Health and Human Services, George Mason University, Fairfax, VA (R.D.H.).""}, {'ForeName': 'Jamie E', 'Initials': 'JE', 'LastName': 'Newman', 'Affiliation': ""From the Department of Pediatrics, University of Pennsylvania, and Children's Hospital of Philadelphia, Philadelphia (H.K., B.S., A.S.C.); the Department of Pediatrics, University of Iowa, Iowa City (E.F.B., K.J.J., J.A.W.); the Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto (S.R.H., V.Y.C.), and the Department of Pediatrics, University of California, Los Angeles, Los Angeles (U.D.) - both in California; the Biostatistics and Epidemiology Division, RTI International, Research Triangle Park (S.T., M.M.C.), and the Department of Pediatrics, Duke University School of Medicine, Durham (C.M.C.) - both in North Carolina; the Biostatistics and Epidemiology Division, RTI International, Rockville (J.E.N., A.D.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda (R.D.H.) - both in Maryland; the Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI (B.R.V., A.R.L.); the Division of Neonatology, University of Alabama at Birmingham, Birmingham (W.A.C.); the University of Rochester School of Medicine and Dentistry, Rochester, NY (C.T.D., M.F.C.); the Department of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston (K.A.K.), and the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (M.H.W.); the University of New Mexico Health Sciences Center, Albuquerque (R.K.O.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (R.K.O., B.A.Y.); the Department of Pediatrics, Indiana University School of Medicine, Indianapolis (B.B.P., G.M.S.); Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (B.B.P., K.S.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W.), and Nationwide Children's Hospital and the Department of Pediatrics, Ohio State University College of Medicine, Columbus (R.S.); the Department of Pediatrics, Dalhousie University, Halifax, NS, Canada (R.K.W.); the Department of Neonatology, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston (J.A.F.Z.); the Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO (W.E.T.); Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (R.M.P.); the Department of Pediatrics, Wayne State University, Detroit (S.C.); and the College of Health and Human Services, George Mason University, Fairfax, VA (R.D.H.).""}, {'ForeName': 'Betty R', 'Initials': 'BR', 'LastName': 'Vohr', 'Affiliation': ""From the Department of Pediatrics, University of Pennsylvania, and Children's Hospital of Philadelphia, Philadelphia (H.K., B.S., A.S.C.); the Department of Pediatrics, University of Iowa, Iowa City (E.F.B., K.J.J., J.A.W.); the Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto (S.R.H., V.Y.C.), and the Department of Pediatrics, University of California, Los Angeles, Los Angeles (U.D.) - both in California; the Biostatistics and Epidemiology Division, RTI International, Research Triangle Park (S.T., M.M.C.), and the Department of Pediatrics, Duke University School of Medicine, Durham (C.M.C.) - both in North Carolina; the Biostatistics and Epidemiology Division, RTI International, Rockville (J.E.N., A.D.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda (R.D.H.) - both in Maryland; the Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI (B.R.V., A.R.L.); the Division of Neonatology, University of Alabama at Birmingham, Birmingham (W.A.C.); the University of Rochester School of Medicine and Dentistry, Rochester, NY (C.T.D., M.F.C.); the Department of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston (K.A.K.), and the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (M.H.W.); the University of New Mexico Health Sciences Center, Albuquerque (R.K.O.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (R.K.O., B.A.Y.); the Department of Pediatrics, Indiana University School of Medicine, Indianapolis (B.B.P., G.M.S.); Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (B.B.P., K.S.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W.), and Nationwide Children's Hospital and the Department of Pediatrics, Ohio State University College of Medicine, Columbus (R.S.); the Department of Pediatrics, Dalhousie University, Halifax, NS, Canada (R.K.W.); the Department of Neonatology, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston (J.A.F.Z.); the Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO (W.E.T.); Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (R.M.P.); the Department of Pediatrics, Wayne State University, Detroit (S.C.); and the College of Health and Human Services, George Mason University, Fairfax, VA (R.D.H.).""}, {'ForeName': 'Waldemar A', 'Initials': 'WA', 'LastName': 'Carlo', 'Affiliation': ""From the Department of Pediatrics, University of Pennsylvania, and Children's Hospital of Philadelphia, Philadelphia (H.K., B.S., A.S.C.); the Department of Pediatrics, University of Iowa, Iowa City (E.F.B., K.J.J., J.A.W.); the Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto (S.R.H., V.Y.C.), and the Department of Pediatrics, University of California, Los Angeles, Los Angeles (U.D.) - both in California; the Biostatistics and Epidemiology Division, RTI International, Research Triangle Park (S.T., M.M.C.), and the Department of Pediatrics, Duke University School of Medicine, Durham (C.M.C.) - both in North Carolina; the Biostatistics and Epidemiology Division, RTI International, Rockville (J.E.N., A.D.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda (R.D.H.) - both in Maryland; the Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI (B.R.V., A.R.L.); the Division of Neonatology, University of Alabama at Birmingham, Birmingham (W.A.C.); the University of Rochester School of Medicine and Dentistry, Rochester, NY (C.T.D., M.F.C.); the Department of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston (K.A.K.), and the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (M.H.W.); the University of New Mexico Health Sciences Center, Albuquerque (R.K.O.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (R.K.O., B.A.Y.); the Department of Pediatrics, Indiana University School of Medicine, Indianapolis (B.B.P., G.M.S.); Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (B.B.P., K.S.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W.), and Nationwide Children's Hospital and the Department of Pediatrics, Ohio State University College of Medicine, Columbus (R.S.); the Department of Pediatrics, Dalhousie University, Halifax, NS, Canada (R.K.W.); the Department of Neonatology, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston (J.A.F.Z.); the Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO (W.E.T.); Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (R.M.P.); the Department of Pediatrics, Wayne State University, Detroit (S.C.); and the College of Health and Human Services, George Mason University, Fairfax, VA (R.D.H.).""}, {'ForeName': 'Carl T', 'Initials': 'CT', 'LastName': ""D'Angio"", 'Affiliation': ""From the Department of Pediatrics, University of Pennsylvania, and Children's Hospital of Philadelphia, Philadelphia (H.K., B.S., A.S.C.); the Department of Pediatrics, University of Iowa, Iowa City (E.F.B., K.J.J., J.A.W.); the Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto (S.R.H., V.Y.C.), and the Department of Pediatrics, University of California, Los Angeles, Los Angeles (U.D.) - both in California; the Biostatistics and Epidemiology Division, RTI International, Research Triangle Park (S.T., M.M.C.), and the Department of Pediatrics, Duke University School of Medicine, Durham (C.M.C.) - both in North Carolina; the Biostatistics and Epidemiology Division, RTI International, Rockville (J.E.N., A.D.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda (R.D.H.) - both in Maryland; the Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI (B.R.V., A.R.L.); the Division of Neonatology, University of Alabama at Birmingham, Birmingham (W.A.C.); the University of Rochester School of Medicine and Dentistry, Rochester, NY (C.T.D., M.F.C.); the Department of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston (K.A.K.), and the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (M.H.W.); the University of New Mexico Health Sciences Center, Albuquerque (R.K.O.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (R.K.O., B.A.Y.); the Department of Pediatrics, Indiana University School of Medicine, Indianapolis (B.B.P., G.M.S.); Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (B.B.P., K.S.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W.), and Nationwide Children's Hospital and the Department of Pediatrics, Ohio State University College of Medicine, Columbus (R.S.); the Department of Pediatrics, Dalhousie University, Halifax, NS, Canada (R.K.W.); the Department of Neonatology, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston (J.A.F.Z.); the Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO (W.E.T.); Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (R.M.P.); the Department of Pediatrics, Wayne State University, Detroit (S.C.); and the College of Health and Human Services, George Mason University, Fairfax, VA (R.D.H.).""}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Kennedy', 'Affiliation': ""From the Department of Pediatrics, University of Pennsylvania, and Children's Hospital of Philadelphia, Philadelphia (H.K., B.S., A.S.C.); the Department of Pediatrics, University of Iowa, Iowa City (E.F.B., K.J.J., J.A.W.); the Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto (S.R.H., V.Y.C.), and the Department of Pediatrics, University of California, Los Angeles, Los Angeles (U.D.) - both in California; the Biostatistics and Epidemiology Division, RTI International, Research Triangle Park (S.T., M.M.C.), and the Department of Pediatrics, Duke University School of Medicine, Durham (C.M.C.) - both in North Carolina; the Biostatistics and Epidemiology Division, RTI International, Rockville (J.E.N., A.D.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda (R.D.H.) - both in Maryland; the Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI (B.R.V., A.R.L.); the Division of Neonatology, University of Alabama at Birmingham, Birmingham (W.A.C.); the University of Rochester School of Medicine and Dentistry, Rochester, NY (C.T.D., M.F.C.); the Department of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston (K.A.K.), and the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (M.H.W.); the University of New Mexico Health Sciences Center, Albuquerque (R.K.O.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (R.K.O., B.A.Y.); the Department of Pediatrics, Indiana University School of Medicine, Indianapolis (B.B.P., G.M.S.); Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (B.B.P., K.S.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W.), and Nationwide Children's Hospital and the Department of Pediatrics, Ohio State University College of Medicine, Columbus (R.S.); the Department of Pediatrics, Dalhousie University, Halifax, NS, Canada (R.K.W.); the Department of Neonatology, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston (J.A.F.Z.); the Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO (W.E.T.); Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (R.M.P.); the Department of Pediatrics, Wayne State University, Detroit (S.C.); and the College of Health and Human Services, George Mason University, Fairfax, VA (R.D.H.).""}, {'ForeName': 'Robin K', 'Initials': 'RK', 'LastName': 'Ohls', 'Affiliation': ""From the Department of Pediatrics, University of Pennsylvania, and Children's Hospital of Philadelphia, Philadelphia (H.K., B.S., A.S.C.); the Department of Pediatrics, University of Iowa, Iowa City (E.F.B., K.J.J., J.A.W.); the Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto (S.R.H., V.Y.C.), and the Department of Pediatrics, University of California, Los Angeles, Los Angeles (U.D.) - both in California; the Biostatistics and Epidemiology Division, RTI International, Research Triangle Park (S.T., M.M.C.), and the Department of Pediatrics, Duke University School of Medicine, Durham (C.M.C.) - both in North Carolina; the Biostatistics and Epidemiology Division, RTI International, Rockville (J.E.N., A.D.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda (R.D.H.) - both in Maryland; the Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI (B.R.V., A.R.L.); the Division of Neonatology, University of Alabama at Birmingham, Birmingham (W.A.C.); the University of Rochester School of Medicine and Dentistry, Rochester, NY (C.T.D., M.F.C.); the Department of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston (K.A.K.), and the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (M.H.W.); the University of New Mexico Health Sciences Center, Albuquerque (R.K.O.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (R.K.O., B.A.Y.); the Department of Pediatrics, Indiana University School of Medicine, Indianapolis (B.B.P., G.M.S.); Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (B.B.P., K.S.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W.), and Nationwide Children's Hospital and the Department of Pediatrics, Ohio State University College of Medicine, Columbus (R.S.); the Department of Pediatrics, Dalhousie University, Halifax, NS, Canada (R.K.W.); the Department of Neonatology, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston (J.A.F.Z.); the Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO (W.E.T.); Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (R.M.P.); the Department of Pediatrics, Wayne State University, Detroit (S.C.); and the College of Health and Human Services, George Mason University, Fairfax, VA (R.D.H.).""}, {'ForeName': 'Brenda B', 'Initials': 'BB', 'LastName': 'Poindexter', 'Affiliation': ""From the Department of Pediatrics, University of Pennsylvania, and Children's Hospital of Philadelphia, Philadelphia (H.K., B.S., A.S.C.); the Department of Pediatrics, University of Iowa, Iowa City (E.F.B., K.J.J., J.A.W.); the Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto (S.R.H., V.Y.C.), and the Department of Pediatrics, University of California, Los Angeles, Los Angeles (U.D.) - both in California; the Biostatistics and Epidemiology Division, RTI International, Research Triangle Park (S.T., M.M.C.), and the Department of Pediatrics, Duke University School of Medicine, Durham (C.M.C.) - both in North Carolina; the Biostatistics and Epidemiology Division, RTI International, Rockville (J.E.N., A.D.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda (R.D.H.) - both in Maryland; the Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI (B.R.V., A.R.L.); the Division of Neonatology, University of Alabama at Birmingham, Birmingham (W.A.C.); the University of Rochester School of Medicine and Dentistry, Rochester, NY (C.T.D., M.F.C.); the Department of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston (K.A.K.), and the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (M.H.W.); the University of New Mexico Health Sciences Center, Albuquerque (R.K.O.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (R.K.O., B.A.Y.); the Department of Pediatrics, Indiana University School of Medicine, Indianapolis (B.B.P., G.M.S.); Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (B.B.P., K.S.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W.), and Nationwide Children's Hospital and the Department of Pediatrics, Ohio State University College of Medicine, Columbus (R.S.); the Department of Pediatrics, Dalhousie University, Halifax, NS, Canada (R.K.W.); the Department of Neonatology, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston (J.A.F.Z.); the Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO (W.E.T.); Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (R.M.P.); the Department of Pediatrics, Wayne State University, Detroit (S.C.); and the College of Health and Human Services, George Mason University, Fairfax, VA (R.D.H.).""}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Schibler', 'Affiliation': ""From the Department of Pediatrics, University of Pennsylvania, and Children's Hospital of Philadelphia, Philadelphia (H.K., B.S., A.S.C.); the Department of Pediatrics, University of Iowa, Iowa City (E.F.B., K.J.J., J.A.W.); the Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto (S.R.H., V.Y.C.), and the Department of Pediatrics, University of California, Los Angeles, Los Angeles (U.D.) - both in California; the Biostatistics and Epidemiology Division, RTI International, Research Triangle Park (S.T., M.M.C.), and the Department of Pediatrics, Duke University School of Medicine, Durham (C.M.C.) - both in North Carolina; the Biostatistics and Epidemiology Division, RTI International, Rockville (J.E.N., A.D.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda (R.D.H.) - both in Maryland; the Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI (B.R.V., A.R.L.); the Division of Neonatology, University of Alabama at Birmingham, Birmingham (W.A.C.); the University of Rochester School of Medicine and Dentistry, Rochester, NY (C.T.D., M.F.C.); the Department of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston (K.A.K.), and the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (M.H.W.); the University of New Mexico Health Sciences Center, Albuquerque (R.K.O.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (R.K.O., B.A.Y.); the Department of Pediatrics, Indiana University School of Medicine, Indianapolis (B.B.P., G.M.S.); Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (B.B.P., K.S.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W.), and Nationwide Children's Hospital and the Department of Pediatrics, Ohio State University College of Medicine, Columbus (R.S.); the Department of Pediatrics, Dalhousie University, Halifax, NS, Canada (R.K.W.); the Department of Neonatology, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston (J.A.F.Z.); the Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO (W.E.T.); Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (R.M.P.); the Department of Pediatrics, Wayne State University, Detroit (S.C.); and the College of Health and Human Services, George Mason University, Fairfax, VA (R.D.H.).""}, {'ForeName': 'Robin K', 'Initials': 'RK', 'LastName': 'Whyte', 'Affiliation': ""From the Department of Pediatrics, University of Pennsylvania, and Children's Hospital of Philadelphia, Philadelphia (H.K., B.S., A.S.C.); the Department of Pediatrics, University of Iowa, Iowa City (E.F.B., K.J.J., J.A.W.); the Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto (S.R.H., V.Y.C.), and the Department of Pediatrics, University of California, Los Angeles, Los Angeles (U.D.) - both in California; the Biostatistics and Epidemiology Division, RTI International, Research Triangle Park (S.T., M.M.C.), and the Department of Pediatrics, Duke University School of Medicine, Durham (C.M.C.) - both in North Carolina; the Biostatistics and Epidemiology Division, RTI International, Rockville (J.E.N., A.D.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda (R.D.H.) - both in Maryland; the Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI (B.R.V., A.R.L.); the Division of Neonatology, University of Alabama at Birmingham, Birmingham (W.A.C.); the University of Rochester School of Medicine and Dentistry, Rochester, NY (C.T.D., M.F.C.); the Department of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston (K.A.K.), and the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (M.H.W.); the University of New Mexico Health Sciences Center, Albuquerque (R.K.O.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (R.K.O., B.A.Y.); the Department of Pediatrics, Indiana University School of Medicine, Indianapolis (B.B.P., G.M.S.); Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (B.B.P., K.S.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W.), and Nationwide Children's Hospital and the Department of Pediatrics, Ohio State University College of Medicine, Columbus (R.S.); the Department of Pediatrics, Dalhousie University, Halifax, NS, Canada (R.K.W.); the Department of Neonatology, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston (J.A.F.Z.); the Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO (W.E.T.); Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (R.M.P.); the Department of Pediatrics, Wayne State University, Detroit (S.C.); and the College of Health and Human Services, George Mason University, Fairfax, VA (R.D.H.).""}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Widness', 'Affiliation': ""From the Department of Pediatrics, University of Pennsylvania, and Children's Hospital of Philadelphia, Philadelphia (H.K., B.S., A.S.C.); the Department of Pediatrics, University of Iowa, Iowa City (E.F.B., K.J.J., J.A.W.); the Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto (S.R.H., V.Y.C.), and the Department of Pediatrics, University of California, Los Angeles, Los Angeles (U.D.) - both in California; the Biostatistics and Epidemiology Division, RTI International, Research Triangle Park (S.T., M.M.C.), and the Department of Pediatrics, Duke University School of Medicine, Durham (C.M.C.) - both in North Carolina; the Biostatistics and Epidemiology Division, RTI International, Rockville (J.E.N., A.D.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda (R.D.H.) - both in Maryland; the Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI (B.R.V., A.R.L.); the Division of Neonatology, University of Alabama at Birmingham, Birmingham (W.A.C.); the University of Rochester School of Medicine and Dentistry, Rochester, NY (C.T.D., M.F.C.); the Department of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston (K.A.K.), and the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (M.H.W.); the University of New Mexico Health Sciences Center, Albuquerque (R.K.O.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (R.K.O., B.A.Y.); the Department of Pediatrics, Indiana University School of Medicine, Indianapolis (B.B.P., G.M.S.); Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (B.B.P., K.S.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W.), and Nationwide Children's Hospital and the Department of Pediatrics, Ohio State University College of Medicine, Columbus (R.S.); the Department of Pediatrics, Dalhousie University, Halifax, NS, Canada (R.K.W.); the Department of Neonatology, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston (J.A.F.Z.); the Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO (W.E.T.); Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (R.M.P.); the Department of Pediatrics, Wayne State University, Detroit (S.C.); and the College of Health and Human Services, George Mason University, Fairfax, VA (R.D.H.).""}, {'ForeName': 'John A F', 'Initials': 'JAF', 'LastName': 'Zupancic', 'Affiliation': ""From the Department of Pediatrics, University of Pennsylvania, and Children's Hospital of Philadelphia, Philadelphia (H.K., B.S., A.S.C.); the Department of Pediatrics, University of Iowa, Iowa City (E.F.B., K.J.J., J.A.W.); the Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto (S.R.H., V.Y.C.), and the Department of Pediatrics, University of California, Los Angeles, Los Angeles (U.D.) - both in California; the Biostatistics and Epidemiology Division, RTI International, Research Triangle Park (S.T., M.M.C.), and the Department of Pediatrics, Duke University School of Medicine, Durham (C.M.C.) - both in North Carolina; the Biostatistics and Epidemiology Division, RTI International, Rockville (J.E.N., A.D.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda (R.D.H.) - both in Maryland; the Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI (B.R.V., A.R.L.); the Division of Neonatology, University of Alabama at Birmingham, Birmingham (W.A.C.); the University of Rochester School of Medicine and Dentistry, Rochester, NY (C.T.D., M.F.C.); the Department of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston (K.A.K.), and the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (M.H.W.); the University of New Mexico Health Sciences Center, Albuquerque (R.K.O.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (R.K.O., B.A.Y.); the Department of Pediatrics, Indiana University School of Medicine, Indianapolis (B.B.P., G.M.S.); Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (B.B.P., K.S.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W.), and Nationwide Children's Hospital and the Department of Pediatrics, Ohio State University College of Medicine, Columbus (R.S.); the Department of Pediatrics, Dalhousie University, Halifax, NS, Canada (R.K.W.); the Department of Neonatology, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston (J.A.F.Z.); the Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO (W.E.T.); Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (R.M.P.); the Department of Pediatrics, Wayne State University, Detroit (S.C.); and the College of Health and Human Services, George Mason University, Fairfax, VA (R.D.H.).""}, {'ForeName': 'Myra H', 'Initials': 'MH', 'LastName': 'Wyckoff', 'Affiliation': ""From the Department of Pediatrics, University of Pennsylvania, and Children's Hospital of Philadelphia, Philadelphia (H.K., B.S., A.S.C.); the Department of Pediatrics, University of Iowa, Iowa City (E.F.B., K.J.J., J.A.W.); the Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto (S.R.H., V.Y.C.), and the Department of Pediatrics, University of California, Los Angeles, Los Angeles (U.D.) - both in California; the Biostatistics and Epidemiology Division, RTI International, Research Triangle Park (S.T., M.M.C.), and the Department of Pediatrics, Duke University School of Medicine, Durham (C.M.C.) - both in North Carolina; the Biostatistics and Epidemiology Division, RTI International, Rockville (J.E.N., A.D.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda (R.D.H.) - both in Maryland; the Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI (B.R.V., A.R.L.); the Division of Neonatology, University of Alabama at Birmingham, Birmingham (W.A.C.); the University of Rochester School of Medicine and Dentistry, Rochester, NY (C.T.D., M.F.C.); the Department of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston (K.A.K.), and the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (M.H.W.); the University of New Mexico Health Sciences Center, Albuquerque (R.K.O.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (R.K.O., B.A.Y.); the Department of Pediatrics, Indiana University School of Medicine, Indianapolis (B.B.P., G.M.S.); Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (B.B.P., K.S.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W.), and Nationwide Children's Hospital and the Department of Pediatrics, Ohio State University College of Medicine, Columbus (R.S.); the Department of Pediatrics, Dalhousie University, Halifax, NS, Canada (R.K.W.); the Department of Neonatology, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston (J.A.F.Z.); the Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO (W.E.T.); Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (R.M.P.); the Department of Pediatrics, Wayne State University, Detroit (S.C.); and the College of Health and Human Services, George Mason University, Fairfax, VA (R.D.H.).""}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Truog', 'Affiliation': ""From the Department of Pediatrics, University of Pennsylvania, and Children's Hospital of Philadelphia, Philadelphia (H.K., B.S., A.S.C.); the Department of Pediatrics, University of Iowa, Iowa City (E.F.B., K.J.J., J.A.W.); the Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto (S.R.H., V.Y.C.), and the Department of Pediatrics, University of California, Los Angeles, Los Angeles (U.D.) - both in California; the Biostatistics and Epidemiology Division, RTI International, Research Triangle Park (S.T., M.M.C.), and the Department of Pediatrics, Duke University School of Medicine, Durham (C.M.C.) - both in North Carolina; the Biostatistics and Epidemiology Division, RTI International, Rockville (J.E.N., A.D.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda (R.D.H.) - both in Maryland; the Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI (B.R.V., A.R.L.); the Division of Neonatology, University of Alabama at Birmingham, Birmingham (W.A.C.); the University of Rochester School of Medicine and Dentistry, Rochester, NY (C.T.D., M.F.C.); the Department of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston (K.A.K.), and the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (M.H.W.); the University of New Mexico Health Sciences Center, Albuquerque (R.K.O.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (R.K.O., B.A.Y.); the Department of Pediatrics, Indiana University School of Medicine, Indianapolis (B.B.P., G.M.S.); Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (B.B.P., K.S.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W.), and Nationwide Children's Hospital and the Department of Pediatrics, Ohio State University College of Medicine, Columbus (R.S.); the Department of Pediatrics, Dalhousie University, Halifax, NS, Canada (R.K.W.); the Department of Neonatology, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston (J.A.F.Z.); the Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO (W.E.T.); Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (R.M.P.); the Department of Pediatrics, Wayne State University, Detroit (S.C.); and the College of Health and Human Services, George Mason University, Fairfax, VA (R.D.H.).""}, {'ForeName': 'Michele C', 'Initials': 'MC', 'LastName': 'Walsh', 'Affiliation': ""From the Department of Pediatrics, University of Pennsylvania, and Children's Hospital of Philadelphia, Philadelphia (H.K., B.S., A.S.C.); the Department of Pediatrics, University of Iowa, Iowa City (E.F.B., K.J.J., J.A.W.); the Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto (S.R.H., V.Y.C.), and the Department of Pediatrics, University of California, Los Angeles, Los Angeles (U.D.) - both in California; the Biostatistics and Epidemiology Division, RTI International, Research Triangle Park (S.T., M.M.C.), and the Department of Pediatrics, Duke University School of Medicine, Durham (C.M.C.) - both in North Carolina; the Biostatistics and Epidemiology Division, RTI International, Rockville (J.E.N., A.D.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda (R.D.H.) - both in Maryland; the Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI (B.R.V., A.R.L.); the Division of Neonatology, University of Alabama at Birmingham, Birmingham (W.A.C.); the University of Rochester School of Medicine and Dentistry, Rochester, NY (C.T.D., M.F.C.); the Department of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston (K.A.K.), and the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (M.H.W.); the University of New Mexico Health Sciences Center, Albuquerque (R.K.O.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (R.K.O., B.A.Y.); the Department of Pediatrics, Indiana University School of Medicine, Indianapolis (B.B.P., G.M.S.); Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (B.B.P., K.S.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W.), and Nationwide Children's Hospital and the Department of Pediatrics, Ohio State University College of Medicine, Columbus (R.S.); the Department of Pediatrics, Dalhousie University, Halifax, NS, Canada (R.K.W.); the Department of Neonatology, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston (J.A.F.Z.); the Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO (W.E.T.); Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (R.M.P.); the Department of Pediatrics, Wayne State University, Detroit (S.C.); and the College of Health and Human Services, George Mason University, Fairfax, VA (R.D.H.).""}, {'ForeName': 'Valerie Y', 'Initials': 'VY', 'LastName': 'Chock', 'Affiliation': ""From the Department of Pediatrics, University of Pennsylvania, and Children's Hospital of Philadelphia, Philadelphia (H.K., B.S., A.S.C.); the Department of Pediatrics, University of Iowa, Iowa City (E.F.B., K.J.J., J.A.W.); the Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto (S.R.H., V.Y.C.), and the Department of Pediatrics, University of California, Los Angeles, Los Angeles (U.D.) - both in California; the Biostatistics and Epidemiology Division, RTI International, Research Triangle Park (S.T., M.M.C.), and the Department of Pediatrics, Duke University School of Medicine, Durham (C.M.C.) - both in North Carolina; the Biostatistics and Epidemiology Division, RTI International, Rockville (J.E.N., A.D.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda (R.D.H.) - both in Maryland; the Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI (B.R.V., A.R.L.); the Division of Neonatology, University of Alabama at Birmingham, Birmingham (W.A.C.); the University of Rochester School of Medicine and Dentistry, Rochester, NY (C.T.D., M.F.C.); the Department of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston (K.A.K.), and the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (M.H.W.); the University of New Mexico Health Sciences Center, Albuquerque (R.K.O.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (R.K.O., B.A.Y.); the Department of Pediatrics, Indiana University School of Medicine, Indianapolis (B.B.P., G.M.S.); Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (B.B.P., K.S.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W.), and Nationwide Children's Hospital and the Department of Pediatrics, Ohio State University College of Medicine, Columbus (R.S.); the Department of Pediatrics, Dalhousie University, Halifax, NS, Canada (R.K.W.); the Department of Neonatology, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston (J.A.F.Z.); the Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO (W.E.T.); Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (R.M.P.); the Department of Pediatrics, Wayne State University, Detroit (S.C.); and the College of Health and Human Services, George Mason University, Fairfax, VA (R.D.H.).""}, {'ForeName': 'Abbot R', 'Initials': 'AR', 'LastName': 'Laptook', 'Affiliation': ""From the Department of Pediatrics, University of Pennsylvania, and Children's Hospital of Philadelphia, Philadelphia (H.K., B.S., A.S.C.); the Department of Pediatrics, University of Iowa, Iowa City (E.F.B., K.J.J., J.A.W.); the Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto (S.R.H., V.Y.C.), and the Department of Pediatrics, University of California, Los Angeles, Los Angeles (U.D.) - both in California; the Biostatistics and Epidemiology Division, RTI International, Research Triangle Park (S.T., M.M.C.), and the Department of Pediatrics, Duke University School of Medicine, Durham (C.M.C.) - both in North Carolina; the Biostatistics and Epidemiology Division, RTI International, Rockville (J.E.N., A.D.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda (R.D.H.) - both in Maryland; the Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI (B.R.V., A.R.L.); the Division of Neonatology, University of Alabama at Birmingham, Birmingham (W.A.C.); the University of Rochester School of Medicine and Dentistry, Rochester, NY (C.T.D., M.F.C.); the Department of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston (K.A.K.), and the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (M.H.W.); the University of New Mexico Health Sciences Center, Albuquerque (R.K.O.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (R.K.O., B.A.Y.); the Department of Pediatrics, Indiana University School of Medicine, Indianapolis (B.B.P., G.M.S.); Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (B.B.P., K.S.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W.), and Nationwide Children's Hospital and the Department of Pediatrics, Ohio State University College of Medicine, Columbus (R.S.); the Department of Pediatrics, Dalhousie University, Halifax, NS, Canada (R.K.W.); the Department of Neonatology, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston (J.A.F.Z.); the Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO (W.E.T.); Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (R.M.P.); the Department of Pediatrics, Wayne State University, Detroit (S.C.); and the College of Health and Human Services, George Mason University, Fairfax, VA (R.D.H.).""}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Sokol', 'Affiliation': ""From the Department of Pediatrics, University of Pennsylvania, and Children's Hospital of Philadelphia, Philadelphia (H.K., B.S., A.S.C.); the Department of Pediatrics, University of Iowa, Iowa City (E.F.B., K.J.J., J.A.W.); the Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto (S.R.H., V.Y.C.), and the Department of Pediatrics, University of California, Los Angeles, Los Angeles (U.D.) - both in California; the Biostatistics and Epidemiology Division, RTI International, Research Triangle Park (S.T., M.M.C.), and the Department of Pediatrics, Duke University School of Medicine, Durham (C.M.C.) - both in North Carolina; the Biostatistics and Epidemiology Division, RTI International, Rockville (J.E.N., A.D.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda (R.D.H.) - both in Maryland; the Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI (B.R.V., A.R.L.); the Division of Neonatology, University of Alabama at Birmingham, Birmingham (W.A.C.); the University of Rochester School of Medicine and Dentistry, Rochester, NY (C.T.D., M.F.C.); the Department of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston (K.A.K.), and the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (M.H.W.); the University of New Mexico Health Sciences Center, Albuquerque (R.K.O.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (R.K.O., B.A.Y.); the Department of Pediatrics, Indiana University School of Medicine, Indianapolis (B.B.P., G.M.S.); Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (B.B.P., K.S.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W.), and Nationwide Children's Hospital and the Department of Pediatrics, Ohio State University College of Medicine, Columbus (R.S.); the Department of Pediatrics, Dalhousie University, Halifax, NS, Canada (R.K.W.); the Department of Neonatology, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston (J.A.F.Z.); the Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO (W.E.T.); Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (R.M.P.); the Department of Pediatrics, Wayne State University, Detroit (S.C.); and the College of Health and Human Services, George Mason University, Fairfax, VA (R.D.H.).""}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Yoder', 'Affiliation': ""From the Department of Pediatrics, University of Pennsylvania, and Children's Hospital of Philadelphia, Philadelphia (H.K., B.S., A.S.C.); the Department of Pediatrics, University of Iowa, Iowa City (E.F.B., K.J.J., J.A.W.); the Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto (S.R.H., V.Y.C.), and the Department of Pediatrics, University of California, Los Angeles, Los Angeles (U.D.) - both in California; the Biostatistics and Epidemiology Division, RTI International, Research Triangle Park (S.T., M.M.C.), and the Department of Pediatrics, Duke University School of Medicine, Durham (C.M.C.) - both in North Carolina; the Biostatistics and Epidemiology Division, RTI International, Rockville (J.E.N., A.D.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda (R.D.H.) - both in Maryland; the Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI (B.R.V., A.R.L.); the Division of Neonatology, University of Alabama at Birmingham, Birmingham (W.A.C.); the University of Rochester School of Medicine and Dentistry, Rochester, NY (C.T.D., M.F.C.); the Department of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston (K.A.K.), and the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (M.H.W.); the University of New Mexico Health Sciences Center, Albuquerque (R.K.O.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (R.K.O., B.A.Y.); the Department of Pediatrics, Indiana University School of Medicine, Indianapolis (B.B.P., G.M.S.); Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (B.B.P., K.S.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W.), and Nationwide Children's Hospital and the Department of Pediatrics, Ohio State University College of Medicine, Columbus (R.S.); the Department of Pediatrics, Dalhousie University, Halifax, NS, Canada (R.K.W.); the Department of Neonatology, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston (J.A.F.Z.); the Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO (W.E.T.); Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (R.M.P.); the Department of Pediatrics, Wayne State University, Detroit (S.C.); and the College of Health and Human Services, George Mason University, Fairfax, VA (R.D.H.).""}, {'ForeName': 'Ravi M', 'Initials': 'RM', 'LastName': 'Patel', 'Affiliation': ""From the Department of Pediatrics, University of Pennsylvania, and Children's Hospital of Philadelphia, Philadelphia (H.K., B.S., A.S.C.); the Department of Pediatrics, University of Iowa, Iowa City (E.F.B., K.J.J., J.A.W.); the Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto (S.R.H., V.Y.C.), and the Department of Pediatrics, University of California, Los Angeles, Los Angeles (U.D.) - both in California; the Biostatistics and Epidemiology Division, RTI International, Research Triangle Park (S.T., M.M.C.), and the Department of Pediatrics, Duke University School of Medicine, Durham (C.M.C.) - both in North Carolina; the Biostatistics and Epidemiology Division, RTI International, Rockville (J.E.N., A.D.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda (R.D.H.) - both in Maryland; the Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI (B.R.V., A.R.L.); the Division of Neonatology, University of Alabama at Birmingham, Birmingham (W.A.C.); the University of Rochester School of Medicine and Dentistry, Rochester, NY (C.T.D., M.F.C.); the Department of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston (K.A.K.), and the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (M.H.W.); the University of New Mexico Health Sciences Center, Albuquerque (R.K.O.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (R.K.O., B.A.Y.); the Department of Pediatrics, Indiana University School of Medicine, Indianapolis (B.B.P., G.M.S.); Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (B.B.P., K.S.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W.), and Nationwide Children's Hospital and the Department of Pediatrics, Ohio State University College of Medicine, Columbus (R.S.); the Department of Pediatrics, Dalhousie University, Halifax, NS, Canada (R.K.W.); the Department of Neonatology, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston (J.A.F.Z.); the Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO (W.E.T.); Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (R.M.P.); the Department of Pediatrics, Wayne State University, Detroit (S.C.); and the College of Health and Human Services, George Mason University, Fairfax, VA (R.D.H.).""}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Cotten', 'Affiliation': ""From the Department of Pediatrics, University of Pennsylvania, and Children's Hospital of Philadelphia, Philadelphia (H.K., B.S., A.S.C.); the Department of Pediatrics, University of Iowa, Iowa City (E.F.B., K.J.J., J.A.W.); the Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto (S.R.H., V.Y.C.), and the Department of Pediatrics, University of California, Los Angeles, Los Angeles (U.D.) - both in California; the Biostatistics and Epidemiology Division, RTI International, Research Triangle Park (S.T., M.M.C.), and the Department of Pediatrics, Duke University School of Medicine, Durham (C.M.C.) - both in North Carolina; the Biostatistics and Epidemiology Division, RTI International, Rockville (J.E.N., A.D.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda (R.D.H.) - both in Maryland; the Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI (B.R.V., A.R.L.); the Division of Neonatology, University of Alabama at Birmingham, Birmingham (W.A.C.); the University of Rochester School of Medicine and Dentistry, Rochester, NY (C.T.D., M.F.C.); the Department of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston (K.A.K.), and the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (M.H.W.); the University of New Mexico Health Sciences Center, Albuquerque (R.K.O.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (R.K.O., B.A.Y.); the Department of Pediatrics, Indiana University School of Medicine, Indianapolis (B.B.P., G.M.S.); Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (B.B.P., K.S.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W.), and Nationwide Children's Hospital and the Department of Pediatrics, Ohio State University College of Medicine, Columbus (R.S.); the Department of Pediatrics, Dalhousie University, Halifax, NS, Canada (R.K.W.); the Department of Neonatology, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston (J.A.F.Z.); the Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO (W.E.T.); Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (R.M.P.); the Department of Pediatrics, Wayne State University, Detroit (S.C.); and the College of Health and Human Services, George Mason University, Fairfax, VA (R.D.H.).""}, {'ForeName': 'Melissa F', 'Initials': 'MF', 'LastName': 'Carmen', 'Affiliation': ""From the Department of Pediatrics, University of Pennsylvania, and Children's Hospital of Philadelphia, Philadelphia (H.K., B.S., A.S.C.); the Department of Pediatrics, University of Iowa, Iowa City (E.F.B., K.J.J., J.A.W.); the Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto (S.R.H., V.Y.C.), and the Department of Pediatrics, University of California, Los Angeles, Los Angeles (U.D.) - both in California; the Biostatistics and Epidemiology Division, RTI International, Research Triangle Park (S.T., M.M.C.), and the Department of Pediatrics, Duke University School of Medicine, Durham (C.M.C.) - both in North Carolina; the Biostatistics and Epidemiology Division, RTI International, Rockville (J.E.N., A.D.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda (R.D.H.) - both in Maryland; the Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI (B.R.V., A.R.L.); the Division of Neonatology, University of Alabama at Birmingham, Birmingham (W.A.C.); the University of Rochester School of Medicine and Dentistry, Rochester, NY (C.T.D., M.F.C.); the Department of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston (K.A.K.), and the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (M.H.W.); the University of New Mexico Health Sciences Center, Albuquerque (R.K.O.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (R.K.O., B.A.Y.); the Department of Pediatrics, Indiana University School of Medicine, Indianapolis (B.B.P., G.M.S.); Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (B.B.P., K.S.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W.), and Nationwide Children's Hospital and the Department of Pediatrics, Ohio State University College of Medicine, Columbus (R.S.); the Department of Pediatrics, Dalhousie University, Halifax, NS, Canada (R.K.W.); the Department of Neonatology, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston (J.A.F.Z.); the Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO (W.E.T.); Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (R.M.P.); the Department of Pediatrics, Wayne State University, Detroit (S.C.); and the College of Health and Human Services, George Mason University, Fairfax, VA (R.D.H.).""}, {'ForeName': 'Uday', 'Initials': 'U', 'LastName': 'Devaskar', 'Affiliation': ""From the Department of Pediatrics, University of Pennsylvania, and Children's Hospital of Philadelphia, Philadelphia (H.K., B.S., A.S.C.); the Department of Pediatrics, University of Iowa, Iowa City (E.F.B., K.J.J., J.A.W.); the Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto (S.R.H., V.Y.C.), and the Department of Pediatrics, University of California, Los Angeles, Los Angeles (U.D.) - both in California; the Biostatistics and Epidemiology Division, RTI International, Research Triangle Park (S.T., M.M.C.), and the Department of Pediatrics, Duke University School of Medicine, Durham (C.M.C.) - both in North Carolina; the Biostatistics and Epidemiology Division, RTI International, Rockville (J.E.N., A.D.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda (R.D.H.) - both in Maryland; the Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI (B.R.V., A.R.L.); the Division of Neonatology, University of Alabama at Birmingham, Birmingham (W.A.C.); the University of Rochester School of Medicine and Dentistry, Rochester, NY (C.T.D., M.F.C.); the Department of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston (K.A.K.), and the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (M.H.W.); the University of New Mexico Health Sciences Center, Albuquerque (R.K.O.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (R.K.O., B.A.Y.); the Department of Pediatrics, Indiana University School of Medicine, Indianapolis (B.B.P., G.M.S.); Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (B.B.P., K.S.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W.), and Nationwide Children's Hospital and the Department of Pediatrics, Ohio State University College of Medicine, Columbus (R.S.); the Department of Pediatrics, Dalhousie University, Halifax, NS, Canada (R.K.W.); the Department of Neonatology, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston (J.A.F.Z.); the Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO (W.E.T.); Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (R.M.P.); the Department of Pediatrics, Wayne State University, Detroit (S.C.); and the College of Health and Human Services, George Mason University, Fairfax, VA (R.D.H.).""}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Chawla', 'Affiliation': ""From the Department of Pediatrics, University of Pennsylvania, and Children's Hospital of Philadelphia, Philadelphia (H.K., B.S., A.S.C.); the Department of Pediatrics, University of Iowa, Iowa City (E.F.B., K.J.J., J.A.W.); the Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto (S.R.H., V.Y.C.), and the Department of Pediatrics, University of California, Los Angeles, Los Angeles (U.D.) - both in California; the Biostatistics and Epidemiology Division, RTI International, Research Triangle Park (S.T., M.M.C.), and the Department of Pediatrics, Duke University School of Medicine, Durham (C.M.C.) - both in North Carolina; the Biostatistics and Epidemiology Division, RTI International, Rockville (J.E.N., A.D.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda (R.D.H.) - both in Maryland; the Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI (B.R.V., A.R.L.); the Division of Neonatology, University of Alabama at Birmingham, Birmingham (W.A.C.); the University of Rochester School of Medicine and Dentistry, Rochester, NY (C.T.D., M.F.C.); the Department of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston (K.A.K.), and the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (M.H.W.); the University of New Mexico Health Sciences Center, Albuquerque (R.K.O.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (R.K.O., B.A.Y.); the Department of Pediatrics, Indiana University School of Medicine, Indianapolis (B.B.P., G.M.S.); Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (B.B.P., K.S.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W.), and Nationwide Children's Hospital and the Department of Pediatrics, Ohio State University College of Medicine, Columbus (R.S.); the Department of Pediatrics, Dalhousie University, Halifax, NS, Canada (R.K.W.); the Department of Neonatology, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston (J.A.F.Z.); the Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO (W.E.T.); Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (R.M.P.); the Department of Pediatrics, Wayne State University, Detroit (S.C.); and the College of Health and Human Services, George Mason University, Fairfax, VA (R.D.H.).""}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Seabrook', 'Affiliation': ""From the Department of Pediatrics, University of Pennsylvania, and Children's Hospital of Philadelphia, Philadelphia (H.K., B.S., A.S.C.); the Department of Pediatrics, University of Iowa, Iowa City (E.F.B., K.J.J., J.A.W.); the Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto (S.R.H., V.Y.C.), and the Department of Pediatrics, University of California, Los Angeles, Los Angeles (U.D.) - both in California; the Biostatistics and Epidemiology Division, RTI International, Research Triangle Park (S.T., M.M.C.), and the Department of Pediatrics, Duke University School of Medicine, Durham (C.M.C.) - both in North Carolina; the Biostatistics and Epidemiology Division, RTI International, Rockville (J.E.N., A.D.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda (R.D.H.) - both in Maryland; the Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI (B.R.V., A.R.L.); the Division of Neonatology, University of Alabama at Birmingham, Birmingham (W.A.C.); the University of Rochester School of Medicine and Dentistry, Rochester, NY (C.T.D., M.F.C.); the Department of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston (K.A.K.), and the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (M.H.W.); the University of New Mexico Health Sciences Center, Albuquerque (R.K.O.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (R.K.O., B.A.Y.); the Department of Pediatrics, Indiana University School of Medicine, Indianapolis (B.B.P., G.M.S.); Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (B.B.P., K.S.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W.), and Nationwide Children's Hospital and the Department of Pediatrics, Ohio State University College of Medicine, Columbus (R.S.); the Department of Pediatrics, Dalhousie University, Halifax, NS, Canada (R.K.W.); the Department of Neonatology, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston (J.A.F.Z.); the Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO (W.E.T.); Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (R.M.P.); the Department of Pediatrics, Wayne State University, Detroit (S.C.); and the College of Health and Human Services, George Mason University, Fairfax, VA (R.D.H.).""}, {'ForeName': 'Rosemary D', 'Initials': 'RD', 'LastName': 'Higgins', 'Affiliation': ""From the Department of Pediatrics, University of Pennsylvania, and Children's Hospital of Philadelphia, Philadelphia (H.K., B.S., A.S.C.); the Department of Pediatrics, University of Iowa, Iowa City (E.F.B., K.J.J., J.A.W.); the Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto (S.R.H., V.Y.C.), and the Department of Pediatrics, University of California, Los Angeles, Los Angeles (U.D.) - both in California; the Biostatistics and Epidemiology Division, RTI International, Research Triangle Park (S.T., M.M.C.), and the Department of Pediatrics, Duke University School of Medicine, Durham (C.M.C.) - both in North Carolina; the Biostatistics and Epidemiology Division, RTI International, Rockville (J.E.N., A.D.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda (R.D.H.) - both in Maryland; the Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI (B.R.V., A.R.L.); the Division of Neonatology, University of Alabama at Birmingham, Birmingham (W.A.C.); the University of Rochester School of Medicine and Dentistry, Rochester, NY (C.T.D., M.F.C.); the Department of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston (K.A.K.), and the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (M.H.W.); the University of New Mexico Health Sciences Center, Albuquerque (R.K.O.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (R.K.O., B.A.Y.); the Department of Pediatrics, Indiana University School of Medicine, Indianapolis (B.B.P., G.M.S.); Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (B.B.P., K.S.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W.), and Nationwide Children's Hospital and the Department of Pediatrics, Ohio State University College of Medicine, Columbus (R.S.); the Department of Pediatrics, Dalhousie University, Halifax, NS, Canada (R.K.W.); the Department of Neonatology, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston (J.A.F.Z.); the Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO (W.E.T.); Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (R.M.P.); the Department of Pediatrics, Wayne State University, Detroit (S.C.); and the College of Health and Human Services, George Mason University, Fairfax, VA (R.D.H.).""}, {'ForeName': 'Abhik', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': ""From the Department of Pediatrics, University of Pennsylvania, and Children's Hospital of Philadelphia, Philadelphia (H.K., B.S., A.S.C.); the Department of Pediatrics, University of Iowa, Iowa City (E.F.B., K.J.J., J.A.W.); the Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto (S.R.H., V.Y.C.), and the Department of Pediatrics, University of California, Los Angeles, Los Angeles (U.D.) - both in California; the Biostatistics and Epidemiology Division, RTI International, Research Triangle Park (S.T., M.M.C.), and the Department of Pediatrics, Duke University School of Medicine, Durham (C.M.C.) - both in North Carolina; the Biostatistics and Epidemiology Division, RTI International, Rockville (J.E.N., A.D.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda (R.D.H.) - both in Maryland; the Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI (B.R.V., A.R.L.); the Division of Neonatology, University of Alabama at Birmingham, Birmingham (W.A.C.); the University of Rochester School of Medicine and Dentistry, Rochester, NY (C.T.D., M.F.C.); the Department of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston (K.A.K.), and the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (M.H.W.); the University of New Mexico Health Sciences Center, Albuquerque (R.K.O.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (R.K.O., B.A.Y.); the Department of Pediatrics, Indiana University School of Medicine, Indianapolis (B.B.P., G.M.S.); Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (B.B.P., K.S.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W.), and Nationwide Children's Hospital and the Department of Pediatrics, Ohio State University College of Medicine, Columbus (R.S.); the Department of Pediatrics, Dalhousie University, Halifax, NS, Canada (R.K.W.); the Department of Neonatology, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston (J.A.F.Z.); the Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO (W.E.T.); Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (R.M.P.); the Department of Pediatrics, Wayne State University, Detroit (S.C.); and the College of Health and Human Services, George Mason University, Fairfax, VA (R.D.H.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2020248'] 1906,33819055,Preventing Hospital Readmission for Patients With Comorbid Substance Use Disorder : A Randomized Trial.,"BACKGROUND Hospitalized patients with comorbid substance use disorders (SUDs) are at high risk for poor outcomes, including readmission and emergency department (ED) use. OBJECTIVE To determine whether patient navigation services reduce hospital readmissions. DESIGN Randomized controlled trial comparing Navigation Services to Avoid Rehospitalization (NavSTAR) versus treatment as usual (TAU). (ClinicalTrials.gov: NCT02599818). SETTING Urban academic hospital in Baltimore, Maryland, with an SUD consultation service. PARTICIPANTS 400 hospitalized adults with comorbid SUD (opioid, cocaine, or alcohol). INTERVENTION NavSTAR used proactive case management, advocacy, service linkage, and motivational support to resolve internal and external barriers to care and address SUD, medical, and basic needs for 3 months after discharge. MEASUREMENTS Data on inpatient readmissions (primary outcome) and ED visits for 12 months were obtained for all participants via the regional health information exchange. Entry into SUD treatment, substance use, and related outcomes were assessed at 3-, 6-, and 12-month follow-up. RESULTS Participants had high levels of acute care use: 69% had an inpatient readmission and 79% visited the ED over the 12-month observation period. Event rates per 1000 person-days were 6.05 (NavSTAR) versus 8.13 (TAU) for inpatient admissions (hazard ratio, 0.74 [95% CI, 0.58 to 0.96]; P = 0.020) and 17.66 (NavSTAR) versus 27.85 (TAU) for ED visits (hazard ratio, 0.66 [CI, 0.49 to 0.89]; P = 0.006). Participants in the NavSTAR group were less likely to have an inpatient readmission within 30 days than those receiving TAU (15.5% vs. 30.0%; P < 0.001) and were more likely to enter community SUD treatment after discharge ( P = 0.014; treatment entry within 3 months, 50.3% NavSTAR vs. 35.3% TAU). LIMITATION Single-site trial, which limits generalizability. CONCLUSION Patient navigation reduced inpatient readmissions and ED visits in this clinically challenging sample of hospitalized patients with comorbid SUDs. PRIMARY FUNDING SOURCE National Institute on Drug Abuse.",2021,"(TAU) for ED visits (hazard ratio, 0.66 [CI, 0.49 to 0.89]; P = 0.006).","['Patients With Comorbid Substance Use Disorder ', '400 hospitalized adults with comorbid SUD (opioid, cocaine, or alcohol', 'Hospitalized patients with comorbid substance use disorders (SUDs', 'Urban academic hospital in Baltimore, Maryland, with an SUD consultation service', 'hospitalized patients with comorbid SUDs']",['Navigation Services to Avoid Rehospitalization (NavSTAR'],"['Hospital Readmission', 'inpatient readmissions and ED visits', 'inpatient readmission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]","[{'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}]",400.0,0.230627,"(TAU) for ED visits (hazard ratio, 0.66 [CI, 0.49 to 0.89]; P = 0.006).","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Gryczynski', 'Affiliation': 'Friends Research Institute, Baltimore, Maryland (J.G., C.D.N., S.G.M., R.P.S.).'}, {'ForeName': 'Courtney D', 'Initials': 'CD', 'LastName': 'Nordeck', 'Affiliation': 'Friends Research Institute, Baltimore, Maryland (J.G., C.D.N., S.G.M., R.P.S.).'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Welsh', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, Maryland (C.W.).'}, {'ForeName': 'Shannon G', 'Initials': 'SG', 'LastName': 'Mitchell', 'Affiliation': 'Friends Research Institute, Baltimore, Maryland (J.G., C.D.N., S.G.M., R.P.S.).'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': ""O'Grady"", 'Affiliation': 'and University of Maryland, College Park, Maryland (K.E.O.).'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Schwartz', 'Affiliation': 'Friends Research Institute, Baltimore, Maryland (J.G., C.D.N., S.G.M., R.P.S.).'}]",Annals of internal medicine,['10.7326/M20-5475'] 1907,33429977,Effect of the Natural Sweetener Xylitol on Gut Hormone Secretion and Gastric Emptying in Humans: A Pilot Dose-Ranging Study.,"Sugar consumption is associated with a whole range of negative health effects and should be reduced and the natural sweetener xylitol might be helpful in achieving this goal. The present study was conducted as a randomized, placebo-controlled, double-blind, cross-over trial. Twelve healthy, lean volunteers received intragastric solutions with 7, 17 or 35 g xylitol or tap water on four separate days. We examined effects on: gut hormones, glucose, insulin, glucagon, uric acid, lipid profile, as well as gastric emptying rates, appetite-related sensations and gastrointestinal symptoms. We found: (i) a dose-dependent stimulation of cholecystokinin (CCK), active glucagon-like peptide-1 (aGLP-1), peptide tyrosine tyrosine (PYY)-release, and decelerated gastric emptying rates, (ii) a dose-dependent increase in blood glucose and insulin, (iii) no effect on motilin, glucagon, or glucose-dependent insulinotropic peptide (GIP)-release, (iv) no effect on blood lipids, but a rise in uric acid, and (v) increased bowel sounds as only side effects. In conclusion, low doses of xylitol stimulate the secretion of gut hormones and induce a deceleration in gastric emptying rates. There is no effect on blood lipids and only little effect on plasma glucose and insulin. This combination of properties (low-glycemic sweetener which stimulates satiation hormone release) makes xylitol an attractive candidate for sugar replacement.",2021,There is no effect on blood lipids and only little effect on plasma glucose and insulin.,"['Twelve healthy, lean volunteers', 'Humans']","['xylitol', 'Natural Sweetener Xylitol', 'placebo', 'cholecystokinin (CCK), active glucagon-like peptide-1']","['gastric emptying rates', 'rise in uric acid, and (v) increased bowel sounds as only side effects', 'blood lipids', 'aGLP-1), peptide tyrosine tyrosine (PYY)-release, and decelerated gastric emptying rates', 'gut hormones, glucose, insulin, glucagon, uric acid, lipid profile, as well as gastric emptying rates, appetite-related sensations and gastrointestinal symptoms', 'plasma glucose and insulin', 'Gut Hormone Secretion and Gastric Emptying', 'blood glucose and insulin, (iii) no effect on motilin, glucagon, or glucose-dependent insulinotropic peptide (GIP)-release, (iv) no effect on blood lipids']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0043369', 'cui_str': 'Xylitol'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0038998', 'cui_str': 'Sweeteners'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008328', 'cui_str': 'Cholecystokinin'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}]","[{'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0232693', 'cui_str': 'Bowel sounds'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0077599', 'cui_str': 'tyrosyltyrosine'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0312431', 'cui_str': 'Hormone secretion'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C1301751', 'cui_str': 'No effect'}, {'cui': 'C0026594', 'cui_str': 'Motilin'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}]",12.0,0.228576,There is no effect on blood lipids and only little effect on plasma glucose and insulin.,"[{'ForeName': 'Anne Christin', 'Initials': 'AC', 'LastName': 'Meyer-Gerspach', 'Affiliation': 'St. Clara Research Ltd. at St. Claraspital, 4002 Basel, Switzerland.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Drewe', 'Affiliation': 'Department of Clinical Pharmacology and Toxicology, University Hospital of Basel, 4001 Basel, Switzerland.'}, {'ForeName': 'Wout', 'Initials': 'W', 'LastName': 'Verbeure', 'Affiliation': 'Translational Research Center for Gastrointestinal Disorders, Catholic University of Leuven, 3000 Leuven, Belgium.'}, {'ForeName': 'Carel W le', 'Initials': 'CWL', 'LastName': 'Roux', 'Affiliation': 'Diabetes Complications Research Centre, Conway Institute University College Dublin, 3444 Dublin, Ireland.'}, {'ForeName': 'Ludmilla', 'Initials': 'L', 'LastName': 'Dellatorre-Teixeira', 'Affiliation': 'Diabetes Complications Research Centre, Conway Institute University College Dublin, 3444 Dublin, Ireland.'}, {'ForeName': 'Jens F', 'Initials': 'JF', 'LastName': 'Rehfeld', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences and Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, 2200 Copenhagen, Denmark.'}, {'ForeName': 'Bolette', 'Initials': 'B', 'LastName': 'Hartmann', 'Affiliation': 'Department of Biomedical Sciences and Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, 2200 Copenhagen, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Tack', 'Affiliation': 'Translational Research Center for Gastrointestinal Disorders, Catholic University of Leuven, 3000 Leuven, Belgium.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Peterli', 'Affiliation': 'Clarunis, Department of Surgery, St. Claraspital, 4002 Basel, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Beglinger', 'Affiliation': 'St. Clara Research Ltd. at St. Claraspital, 4002 Basel, Switzerland.'}, {'ForeName': 'Bettina K', 'Initials': 'BK', 'LastName': 'Wölnerhanssen', 'Affiliation': 'St. Clara Research Ltd. at St. Claraspital, 4002 Basel, Switzerland.'}]",Nutrients,['10.3390/nu13010174'] 1908,33480860,"Efficacy of a Transdiagnostic Self-Help Internet Intervention for Reducing Depression, Anxiety, and Suicidal Ideation in Adults: Randomized Controlled Trial.","BACKGROUND Low-intensity self-guided mental health interventions that are delivered on the web may meet the needs and preferences of adults with mild to moderate symptoms. However, few clinical trials have examined the effectiveness of self-guided transdiagnostic interventions within a naturalistic setting. OBJECTIVE This randomized controlled trial (RCT) tests the effectiveness of the video-based transdiagnostic intervention FitMindKit in reducing depression symptoms (primary outcome), anxiety symptoms, disability, and suicidal ideation, relative to an attention-matched control condition called HealthWatch. METHODS The RCT was conducted with adults living in the Australian Capital Territory, Australia. Participants (n=1986) were recruited through the web using social media advertisements, screened for psychological distress, and then randomized to receive one of two 4-week programs: FitMindKit (12-module psychotherapy intervention) or HealthWatch (12-module program providing general health information). Participants were assessed at baseline and at 4 weeks postbaseline. To maintain the ecological validity of the trial, participants completed brief assessments and interventions without direct researcher contact or incentives. RESULTS Mixed model repeated-measures analyses of variance demonstrated that FitMindKit significantly improved depression symptoms (F 1,701.7 =3.97; P=.047), along with panic symptoms (F 1,706.5 =5.59; P=.02) and social anxiety symptoms (F 1,680.0 =12.37; P<.001), relative to the attention control condition. There were no significant effects on other outcomes. CONCLUSIONS Self-guided transdiagnostic interventions can be beneficial when delivered directly to end users through the internet. Despite low adherence and small effect sizes, the availability of such interventions is likely to fill a critical gap in the accessibility of mental health services for the community. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry ACTRN12618001688279; http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376113. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) RR2-10.1016/j.conctc.2019.100341.",2021,"RESULTS Mixed model repeated-measures analyses of variance demonstrated that FitMindKit significantly improved depression symptoms (F 1,701.7 =3.97; P=.047), along with panic symptoms (F 1,706.5 =5.59; P=.02) and social anxiety symptoms (F 1,680.0 =12.37; P<.001), relative to the attention control condition.","['adults with mild to moderate symptoms', 'adults living in the Australian Capital Territory, Australia', 'Participants (n=1986) were recruited through the web using social media advertisements, screened for psychological distress', 'Adults']","['FitMindKit (12-module psychotherapy intervention) or HealthWatch (12-module program providing general health information', 'video-based transdiagnostic intervention FitMindKit', 'Transdiagnostic Self-Help Internet Intervention', 'direct researcher contact or incentives']","['depression symptoms', 'Depression, Anxiety, and Suicidal Ideation', 'panic symptoms', 'social anxiety symptoms', 'depression symptoms (primary outcome), anxiety symptoms, disability, and suicidal ideation, relative to an attention-matched control condition called HealthWatch']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0454764', 'cui_str': 'Australian Capital Territory'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}]","[{'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1720420', 'cui_str': 'Call'}]",1986.0,0.325699,"RESULTS Mixed model repeated-measures analyses of variance demonstrated that FitMindKit significantly improved depression symptoms (F 1,701.7 =3.97; P=.047), along with panic symptoms (F 1,706.5 =5.59; P=.02) and social anxiety symptoms (F 1,680.0 =12.37; P<.001), relative to the attention control condition.","[{'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Batterham', 'Affiliation': 'Centre for Mental Health Research, Research School of Population Health, Australian National University, Canberra ACT, Australia.'}, {'ForeName': 'Alison L', 'Initials': 'AL', 'LastName': 'Calear', 'Affiliation': 'Centre for Mental Health Research, Research School of Population Health, Australian National University, Canberra ACT, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Farrer', 'Affiliation': 'Centre for Mental Health Research, Research School of Population Health, Australian National University, Canberra ACT, Australia.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Gulliver', 'Affiliation': 'Centre for Mental Health Research, Research School of Population Health, Australian National University, Canberra ACT, Australia.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Kurz', 'Affiliation': 'Centre for Mental Health Research, Research School of Population Health, Australian National University, Canberra ACT, Australia.'}]",Journal of medical Internet research,['10.2196/22698'] 1909,33460240,Internet-delivered acceptance and commitment therapy as microlearning for chronic pain: A randomized controlled trial with 1-year follow-up.,"BACKGROUND Studies of Internet-delivered acceptance and commitment therapy (ACT) for chronic pain have shown small to moderate positive effects for pain interference and pain acceptance. Effects on pain intensity, depression, anxiety and quality of life (QoL) have been less favourable, and improvements for values and sleep are lacking. In this randomized controlled trial iACT - a novel format of Internet-ACT using daily microlearning exercises - was examined for efficacy compared to a waitlist condition. METHODS Adult participants (mean age 49.5 years, pain duration 18.1 years) with diverse chronic pain conditions were recruited via self-referral, and randomized to iACT (n = 57) or waitlist (n = 56). The primary outcome was pain interference. The secondary outcomes were QoL, depression, anxiety, insomnia and pain intensity. The process variables included psychological inflexibility and values. Post-assessments were completed by 88% (n = 100) of participants. Twelve-month follow-up assessments were completed by 65% (iACT only, n = 37). Treatment efficacy was analysed using linear mixed models and an intention-to-treat-approach. RESULTS Significant improvements in favour of iACT were seen for pain interference, depression, anxiety, pain intensity and insomnia, as well as process variables psychological inflexibility and values. Between-group effect sizes were large for pain interference (d = 0.99) and pain intensity (d = 1.2), moderate for anxiety and depressive symptoms and small for QoL and insomnia. For the process variables, the between-group effect size was large for psychological inflexibility (d = 1.0) and moderate for values. All improvements were maintained at 1-year follow-up. CONCLUSIONS Internet-ACT as microlearning may improve a broad range of outcomes in chronic pain. SIGNIFICANCE The study evaluates a novel behavioral treatment with positive results on pain interference, mood as well as pain intensity for longtime chronic pain sufferers. The innovative format of a digital ACT intervention delivered in short and experiential daily learnings may be a promising way forward.",2021,"RESULTS Significant improvements in favour of iACT were seen for pain interference, depression, anxiety, pain intensity and insomnia, as well as process variables psychological inflexibility and values.","['chronic pain', 'Adult participants (mean age 49.5\xa0years, pain duration 18.1\xa0years) with diverse chronic pain conditions were recruited via self-referral, and randomized to iACT (n\xa0=\xa057) or waitlist (n\xa0=\xa056', 'longtime chronic pain sufferers']","['Internet-delivered acceptance and commitment therapy', 'Internet-delivered acceptance and commitment therapy (ACT', 'digital ACT intervention']","['pain intensity, depression, anxiety and quality of life (QoL', 'QoL, depression, anxiety, insomnia and pain intensity', 'psychological inflexibility', 'pain interference, mood as well as pain intensity', 'pain interference', 'pain intensity', 'pain interference, depression, anxiety, pain intensity and insomnia, as well as process variables psychological inflexibility and values', 'psychological inflexibility and values', 'moderate for anxiety and depressive symptoms and small for QoL and insomnia']","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0237824', 'cui_str': 'Self-referral'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}]",,0.238959,"RESULTS Significant improvements in favour of iACT were seen for pain interference, depression, anxiety, pain intensity and insomnia, as well as process variables psychological inflexibility and values.","[{'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Rickardsson', 'Affiliation': 'Functional Unit Behavioral Medicine, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Gentili', 'Affiliation': 'Functional Unit Behavioral Medicine, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Holmström', 'Affiliation': 'Functional Unit Behavioral Medicine, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Vendela', 'Initials': 'V', 'LastName': 'Zetterqvist', 'Affiliation': 'Functional Unit Behavioral Medicine, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Andersson', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Persson', 'Affiliation': 'Functional Unit Behavioral Medicine, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Lekander', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Brjánn', 'Initials': 'B', 'LastName': 'Ljótsson', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Rikard K', 'Initials': 'RK', 'LastName': 'Wicksell', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}]","European journal of pain (London, England)",['10.1002/ejp.1723'] 1910,33465768,Treatment with Diazepam in Acute Stroke Prevents Poststroke Seizures: A Substudy of the EGASIS Trial.,"OBJECTIVE The frequency of seizures after stroke is high, with a severe impact on the quality of life. However, little is known about their prevention. Therefore, we investigated whether early administration of diazepam prevents the development of seizures in acute stroke patients. METHODS We performed a substudy of the EGASIS trial, a multicenter double-blind, randomized trial in which acute stroke patients were treated with diazepam or placebo for 3 days. Follow-up was after 2 weeks and 3 months. The occurrence of seizures was registered prospectively as one of the prespecified secondary outcomes. RESULTS 784 EGASIS patients were eligible for this substudy (389 treated with diazepam [49.6%] and 395 treated with placebo [50.4%]). Seizures were reported in 19 patients (2.4% of the total patient group). Seizures occurred less frequently in patients treated with diazepam (1.5 vs. 3.3% in the placebo group); however, this difference was only statistically significant in patients with a cortical anterior circulation infarction (0.9% in the diazepam group vs. 4.6% in the placebo group, incidence rate ratio 0.20, 95% CI: 0.05-0.78, p = 0.02, NNT = 27). CONCLUSION We found that a 3-day treatment with diazepam after acute cortical anterior circulation stroke prevents the occurrence of seizures in the first 3 months following stroke.",2021,"Seizures occurred less frequently in patients treated with diazepam (1.5 vs. 3.3% in the placebo group); however, this difference was only statistically significant in patients with a cortical anterior circulation infarction (0.9% in the diazepam group vs. 4.6% in the placebo group, incidence rate ratio 0.20, 95% CI: 0.05-0.78, p = 0.02, NNT = 27). ","['784 EGASIS patients were eligible for this substudy (389 treated with', 'acute stroke patients']","['diazepam or placebo', 'diazepam', 'placebo', 'Diazepam']","['Poststroke Seizures', 'Seizures', 'cortical anterior circulation infarction', 'occurrence of seizures']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517752', 'cui_str': '389'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}]","[{'cui': 'C0012010', 'cui_str': 'Diazepam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",784.0,0.633547,"Seizures occurred less frequently in patients treated with diazepam (1.5 vs. 3.3% in the placebo group); however, this difference was only statistically significant in patients with a cortical anterior circulation infarction (0.9% in the diazepam group vs. 4.6% in the placebo group, incidence rate ratio 0.20, 95% CI: 0.05-0.78, p = 0.02, NNT = 27). ","[{'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'van Tuijl', 'Affiliation': 'Department of Neurology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Elisabeth P M', 'Initials': 'EPM', 'LastName': 'van Raak', 'Affiliation': 'Department of Neurology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'van Oostenbrugge', 'Affiliation': 'Department of Neurology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Albert P', 'Initials': 'AP', 'LastName': 'Aldenkamp', 'Affiliation': 'Department of Neurology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Rob P W', 'Initials': 'RPW', 'LastName': 'Rouhl', 'Affiliation': 'Department of Neurology, Maastricht University Medical Center, Maastricht, The Netherlands, R.Rouhl@mumc.nl.'}]","Cerebrovascular diseases (Basel, Switzerland)",['10.1159/000512799'] 1911,33481829,Tai Chi training's effect on lower extremity muscle co-contraction during single- and dual-task gait: Cross-sectional and randomized trial studies.,"BACKGROUND Tai Chi (TC) mind-body exercise has been shown to reduce falls and improve balance and gait, however, few studies have evaluated the role of lower extremity muscle activation patterns in the observed benefits of TC on mobility. PURPOSE To perform an exploratory analysis of the association between TC training and levels of lower extremity muscle co-contraction in healthy adults during walking under single-task (ST) and cognitive dual-task (DT) conditions. METHODS Surface electromyography of the anterior tibialis and lateral gastrocnemius muscles was recorded during 90 sec trials of overground ST (walking normally) and DT (walking with verbalized serial subtractions) walking. A mean co-contraction index (CCI), across all strides, was calculated based on the percentage of total muscle activity when antagonist muscles were simultaneously activated. A hybrid study design investigated long-term effects of TC via a cross-sectional comparison of 27 TC experts and 60 age-matched TC-naïve older adults. A longitudinal comparison assessed the shorter-term effects of TC; TC-naïve participants were randomly allocated to either 6 months of TC training or to usual care. RESULTS Across all participants at baseline, greater CCI was correlated with slower gait speed under DT (β(95% CI) = -26.1(-48.6, -3.7)) but not ST (β(95% CI) = -15.4(-38.2, 7.4)) walking. Linear models adjusting for age, gender, BMI and other factors that differed at baseline indicated that TC experts exhibited lower CCI compared to TC naives under DT, but not ST conditions (ST: mean difference (95% CI) = -7.1(-15.2, 0.97); DT: mean difference (95% CI) = -10.1(-18.1, -2.4)). No differences were observed in CCI for TC-naive adults randomly assigned to 6 months of TC vs. usual care. CONCLUSION Lower extremity muscle co-contraction may play a role in the observed benefit of longer-term TC training on gait and postural control. Longer-duration and adequately powered randomized trials are needed to evaluate the effect of TC on neuromuscular coordination and its impact on postural control. TRIAL REGISTRATION The randomized trial component of this study was registered at ClinicalTrials.gov (NCT01340365).",2021,"No differences were observed in CCI for TC-naive adults randomly assigned to 6 months of TC vs. usual care. ","['healthy adults during', '27 TC experts and 60 age-matched TC-naïve older adults', 'naïve participants']","['TC; TC', 'TC training or to usual care', 'walking under single-task (ST) and cognitive dual-task (DT) conditions', 'overground ST (walking normally) and DT (walking with verbalized serial subtractions) walking', 'single- and dual-task gait', 'TC', ""Tai Chi training's"", 'Tai Chi (TC) mind-body exercise']","['slower gait speed under DT', 'mean co-contraction index (CCI', 'lower extremity muscle co-contraction', 'CCI']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",,0.0552766,"No differences were observed in CCI for TC-naive adults randomly assigned to 6 months of TC vs. usual care. ","[{'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Wayne', 'Affiliation': ""Osher Center for Integrative Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States of America.""}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Gow', 'Affiliation': ""Osher Center for Integrative Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States of America.""}, {'ForeName': 'Fengzhen', 'Initials': 'F', 'LastName': 'Hou', 'Affiliation': 'Key Laboratory of Biomedical Functional Materials, School of Science, China Pharmaceutical University, Nanjing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Division of Interdisciplinary Medicine and Biotechnology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Hausdorff', 'Affiliation': 'Center for the Study of Movement, Cognition, and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Sagol School of Neuroscience and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Lo', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Pamela M', 'Initials': 'PM', 'LastName': 'Rist', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States of America.""}, {'ForeName': 'Chung-Kang', 'Initials': 'CK', 'LastName': 'Peng', 'Affiliation': 'Division of Interdisciplinary Medicine and Biotechnology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Lewis A', 'Initials': 'LA', 'LastName': 'Lipsitz', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Novak', 'Affiliation': 'Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Manor', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, Boston, Massachusetts, United States of America.'}]",PloS one,['10.1371/journal.pone.0242963'] 1912,33486048,Effects of non-supervised aerobic exercise on sleep quality and maternal-fetal attachment in pregnant women: A randomized controlled trial.,"OBJECTIVES This study was designed to evaluate the effect in pregnant women of a non-supervised aerobic exercise intervention on sleep quality and maternal-fetal attachment. DESIGN Pretest-posttest randomized controlled trial. SETTING Prenatal clinic of a medical center in southern Taiwan. PARTICIPANTS One hundred and forty eligible, pregnant women were assigned systematically, at a random starting point, to either the experimental group (n = 70) or the control group (n = 70). INTERVENTION Participants in the experimental group received a 20-minute, low-impact aerobic exercise video on DVD and were instructed to exercise at home at least three times per week for a period of three months. Participants in the control group received routine prenatal care only. MAIN OUTCOME MEASURES The Pittsburgh Sleep Quality Index and Modified Maternal-Fetal Attachment Scale were used to assess outcome measures before the intervention and at four and 12-weeks post-intervention. RESULTS The paired-sample t-tests revealed a significant improvement in sleep quality in the experimental group at 4-weeks posttest, which persisted through 12-weeks posttest. In addition, the experimental group reported a significantly higher mean score for maternal-fetal attachment at 4-weeks posttest than the control group. CONCLUSION The results of this study indicate that performing aerobic exercise ameliorates the decline in sleep quality and improves maternal-fetal attachment in women who are pregnant. These findings may be used to encourage pregnant women to regularly perform low-impact aerobic exercise.",2021,"In addition, the experimental group reported a significantly higher mean score for maternal-fetal attachment at 4-weeks posttest than the control group. ","['pregnant women', 'One hundred and forty eligible', 'pregnant women of a non', 'women who are pregnant', 'Prenatal clinic of a medical center in southern Taiwan']","['supervised aerobic exercise intervention', 'aerobic exercise', 'routine prenatal care only', 'non-supervised aerobic exercise', 'low-impact aerobic exercise video on DVD and were instructed to exercise']","['mean score for maternal-fetal attachment', 'sleep quality', 'Pittsburgh Sleep Quality Index and Modified Maternal-Fetal Attachment Scale', 'sleep quality and improves maternal-fetal attachment', 'sleep quality and maternal-fetal attachment']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",140.0,0.0965548,"In addition, the experimental group reported a significantly higher mean score for maternal-fetal attachment at 4-weeks posttest than the control group. ","[{'ForeName': 'Wen-Chun', 'Initials': 'WC', 'LastName': 'Shen', 'Affiliation': 'Institute of Allied Health Sciences, College of Medicine, National Cheng Kung University, and Case Manager, Department of Neurology, National Cheng Kung University Hospital, Tainan, Taiwan. Electronic address: nckuwenchun@gmail.com.'}, {'ForeName': 'Chung-Hey', 'Initials': 'CH', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, Hungkuang University, Taichung, and Adjunct Professor, Department of Nursing & Institute of Allied Health Sciences, National Cheng Kung University, Tainan, Taiwan. Electronic address: chunghey@ncku.edu.tw.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2021.102671'] 1913,32332475,The Effects of a Gluten-Free Diet on Immune Markers and Kynurenic Acid Pathway Metabolites in Patients With Schizophrenia Positive for Antigliadin Antibodies Immunoglobulin G.,,2020,,['Patients With Schizophrenia Positive for Antigliadin Antibodies'],"['Gluten-Free Diet', 'Immunoglobulin G']",['Immune Markers and Kynurenic Acid Pathway Metabolites'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C4552268', 'cui_str': 'Antigliadin antibody'}]","[{'cui': 'C0344351', 'cui_str': 'Gluten free diet'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}]","[{'cui': 'C0162489', 'cui_str': 'Immunologic Marker'}, {'cui': 'C0022816', 'cui_str': 'Kynurenic acid'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",,0.0230119,,"[{'ForeName': 'C Renay', 'Initials': 'CR', 'LastName': 'Friendshuh', 'Affiliation': ''}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Pocivavsek', 'Affiliation': ''}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Demyonovich', 'Affiliation': ''}, {'ForeName': 'Katrina M', 'Initials': 'KM', 'LastName': 'Rodriguez', 'Affiliation': ''}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Cihakova', 'Affiliation': ''}, {'ForeName': 'Monica V', 'Initials': 'MV', 'LastName': 'Talor', 'Affiliation': ''}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Richardson', 'Affiliation': ''}, {'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Vyas', 'Affiliation': ''}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Adams', 'Affiliation': ''}, {'ForeName': 'Annalisa B', 'Initials': 'AB', 'LastName': 'Baratta', 'Affiliation': ''}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Fasano', 'Affiliation': ''}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Cascella', 'Affiliation': ''}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Feldman', 'Affiliation': ''}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Sayer', 'Affiliation': ''}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Powell', 'Affiliation': ''}, {'ForeName': 'Heidi J', 'Initials': 'HJ', 'LastName': 'Wehring', 'Affiliation': ''}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Buchanan', 'Affiliation': ''}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Carpenter', 'Affiliation': ''}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Eaton', 'Affiliation': ''}, {'ForeName': 'Deanna L', 'Initials': 'DL', 'LastName': 'Kelly', 'Affiliation': ''}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001197'] 1914,33822466,Re: Vaginal Er:YAG laser application in the menopausal ewe model: a randomised estrogen and sham-controlled trial.,,2021,,"['menopausal ewe model', 'Re']",['Vaginal Er:YAG laser application'],[],"[{'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0337831', 'cui_str': 'Ewe'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0457903', 'cui_str': 'Erbium:YAG laser device'}, {'cui': 'C0185125', 'cui_str': 'Application'}]",[],,0.337268,,"[{'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Gaspar', 'Affiliation': 'University of Mendoza, Mendoza, Argentina.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Gambacciani', 'Affiliation': 'University Hospital Pisa, Pisa, Italy.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16655'] 1915,33422518,Acute kidney injury after radial or femoral artery access in ST-segment elevation myocardial infarction: AKI-SAFARI.,"BACKGROUND Acute kidney injury (AKI) complicating primary percutaneous coronary intervention (PCI) is an independent predictor of short- and long-term outcomes in patients presenting with ST-elevation myocardial infarction (STEMI). Prior studies suggest a lower incidence of AKI in patients undergoing PCI through radial artery compared to femoral artery access; however, no randomized clinical trials have specifically investigated this question in patients presenting with STEMI. METHODS To determine whether radial access (RA) is associated with a reduced frequency of AKI following primary PCI, we performed a substudy of the SAFARI-STEMI trial. The SAFARI-STEMI trial was an open-label, multicenter trial, which randomized patients presenting with STEMI to RA or femoral access (FA), between July 2011 and December 2018. The primary outcome of this post hoc analysis was the incidence of AKI, defined as an absolute (>0.5 mg/dL) or relative (>25%) increase in serum creatinine from baseline. RESULTS In total 2,285 (99.3%) of the patients enrolled in SAFARI-STEMI were included in the analysis-1,132 RA and 1,153 FA. AKI occurred in 243 (21.5%) RA patients and 226 (19.6%) FA patients (RR: 0.91, 95% CI: 0.78-1.07, P = .27). An absolute increase in serum creatinine >0.5 mg/dL was seen in 49 (4.3%) radial and 52 (4.5%) femoral patients (RR: 1.04, 95% CI: 0.71-1.53, P = .83). AKI was lower in both groups when the KDIGO definition was applied (RA 11.9% vs FA 10.8%; RR: 0.90, 95% CI: 0.72-1.13, P = .38). CONCLUSIONS Among STEMI patients enrolled in the SAFARI-STEMI trial, there was no association between catheterization access site and AKI, irrespective of the definition applied. These results challenge the independent association between catheterization access site and AKI noted in prior investigations.",2021,"AKI was lower in both groups when the KDIGO definition was applied (RA 11.9% vs. FA 10.8%; RR 0.90, 95% CI 0.72-1.13; p=0.38). ","['Acute Kidney Injury after Radial or Femoral Artery Access in ST-Segment Elevation Myocardial Infarction', 'patients presenting with ST-elevation myocardial infarction (STEMI', 'patients presenting with STEMI to radial access (RA) or femoral access (FA), between July 2011 and December 2018', 'patients undergoing', 'patients presenting with STEMI']",['percutaneous coronary intervention'],"['AKI', 'serum creatinine', 'incidence of AKI']","[{'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",2285.0,0.564728,"AKI was lower in both groups when the KDIGO definition was applied (RA 11.9% vs. FA 10.8%; RR 0.90, 95% CI 0.72-1.13; p=0.38). ","[{'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Marbach', 'Affiliation': 'CAPITAL Research Group, Division of Cardiology, Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Wells', 'Affiliation': 'Division of Statistics and Epidemiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Pietro Di', 'Initials': 'PD', 'LastName': 'Santo', 'Affiliation': 'CAPITAL Research Group, Division of Cardiology, Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'So', 'Affiliation': 'CAPITAL Research Group, Division of Cardiology, Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Aun-Yeong', 'Initials': 'AY', 'LastName': 'Chong', 'Affiliation': 'CAPITAL Research Group, Division of Cardiology, Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Russo', 'Affiliation': 'CAPITAL Research Group, Division of Cardiology, Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Marino', 'Initials': 'M', 'LastName': 'Labinaz', 'Affiliation': 'CAPITAL Research Group, Division of Cardiology, Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Dick', 'Affiliation': 'CAPITAL Research Group, Division of Cardiology, Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Froeschl', 'Affiliation': 'CAPITAL Research Group, Division of Cardiology, Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Glover', 'Affiliation': 'CAPITAL Research Group, Division of Cardiology, Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Hibbert', 'Affiliation': 'CAPITAL Research Group, Division of Cardiology, Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Marquis', 'Affiliation': 'CAPITAL Research Group, Division of Cardiology, Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'MacDougall', 'Affiliation': 'Department of Medicine, Thunder Bay Regional Health Sciences Centre, Thunder Bay, Ontario, Canada.'}, {'ForeName': 'Malek', 'Initials': 'M', 'LastName': 'Kass', 'Affiliation': 'Department of Medicine, St. Boniface General Hospital, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Vernon', 'Initials': 'V', 'LastName': 'Paddock', 'Affiliation': 'Department of Medicine, Saint John Regional Hospital, Saint John, New Brunswick, Canada.'}, {'ForeName': 'Ata Ur Rehman', 'Initials': 'AUR', 'LastName': 'Quraishi', 'Affiliation': 'Dalhousie University, QE II Health Sciences Centre, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Jaya', 'Initials': 'J', 'LastName': 'Chandrasekhar', 'Affiliation': 'Department of Cardiology, Box Hill Hospital, Eastern Health Clinical School and Monash University, Melbourne, Australia.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Ghosh', 'Affiliation': 'CAPITAL Research Group, Division of Cardiology, Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Bernick', 'Affiliation': 'Division of Statistics and Epidemiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Le May', 'Affiliation': 'CAPITAL Research Group, Division of Cardiology, Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada. Electronic address: MLemay@ottawaheart.ca.'}]",American heart journal,['10.1016/j.ahj.2020.12.019'] 1916,33422517,An immediate or early invasive strategy in non-ST-elevation acute coronary syndrome: The OPTIMA-2 randomized controlled trial.,"BACKGROUND In intermediate- and high-risk non-ST elevated acute coronary syndrome (NSTE-ACS) patients, a routine invasive approach is recommended. The timing of coronary angiography remains controversial. To assess whether an immediate (<3 hours) invasive treatment strategy would reduce infarct size and is safe, compared with an early strategy (12-24 hours), for patients admitted with NSTE-ACS while preferably treated with ticagrelor. METHODS In this single-center, prospective, randomized trial an immediate or early invasive strategy was randomly assigned to patients with NSTE-ACS. At admission, the patients were preferably treated with a combination of aspirin, ticagrelor and fondaparinux. The primary endpoint was the infarct size as measured by area under the curve (AUC) of CK-MB in 48 hours. Secondary endpoints were bleeding outcomes and major adverse cardiac events (MACE): composite of all-cause death, MI and unplanned revascularization. Interim analysis showed futility regarding the primary endpoint and trial inclusion was terminated. RESULTS In total 249 patients (71% of planned) were included. The primary endpoint of in-hospital infarct size was a median AUC of CK-MB 186.2 ng/mL in the immediate group (IQR 112-618) and 201.3 ng/mL in the early group (IQR 119-479). Clinical follow-up was 1-year. The MACE-rate was 10% in the immediate and 10% in the early group (hazard ratio [HR] 1.13, 95% CI: 0.52-2.49). CONCLUSIONS In NSTE-ACS patients randomized to either an immediate or an early-invasive strategy the observed median difference in the primary endpoint was about half the magnitude of the expected difference. The trial was terminated early for futility after 71% of the projected enrollment had been randomized into the trial.",2021,The primary endpoint of in-hospital infarct size was a median AUC of CK-MB 186.2 ng/mL in the immediate group [IQR 112-618] and 201.3 ng/mL in the early group [IQR 119-479].,"['patients with NSTE-ACS', 'non-ST-elevation acute coronary syndrome', 'In total 249 patients (71% of planned) were included']","['ticagrelor', 'aspirin, ticagrelor and fondaparinux']","['composite of all-cause death, MI and unplanned revascularization', 'bleeding outcomes and major adverse cardiac events (MACE', 'MACE-rate', 'hospital infarct size', 'infarct size as measured by area under the curve (AUC) of CK-MB']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C1098510', 'cui_str': 'fondaparinux'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0010290', 'cui_str': 'Creatine kinase isoenzyme, MB fraction'}]",,0.312809,The primary endpoint of in-hospital infarct size was a median AUC of CK-MB 186.2 ng/mL in the immediate group [IQR 112-618] and 201.3 ng/mL in the early group [IQR 119-479].,"[{'ForeName': 'Nick D', 'Initials': 'ND', 'LastName': 'Fagel', 'Affiliation': 'Heart Center, OLVG Hospital, Amsterdam, the Netherlands. Electronic address: n.d.fagel@olvg.nl.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Amoroso', 'Affiliation': 'Heart Center, OLVG Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Maarten A', 'Initials': 'MA', 'LastName': 'Vink', 'Affiliation': 'Heart Center, OLVG Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Ton', 'Initials': 'T', 'LastName': 'Slagboom', 'Affiliation': 'Heart Center, OLVG Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'René J', 'Initials': 'RJ', 'LastName': 'van der Schaaf', 'Affiliation': 'Heart Center, OLVG Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Herrman', 'Affiliation': 'Heart Center, OLVG Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Patterson', 'Affiliation': 'Heart Center, OLVG Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Erik F J', 'Initials': 'EFJ', 'LastName': 'Oosterwerff', 'Affiliation': 'Division of Cardiology, Isala Hospital, Zwolle, the Netherlands.'}, {'ForeName': 'Nicola S', 'Initials': 'NS', 'LastName': 'Vos', 'Affiliation': 'Heart Center, OLVG Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Freek W A', 'Initials': 'FWA', 'LastName': 'Verheugt', 'Affiliation': 'Heart Center, OLVG Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Jan G P', 'Initials': 'JGP', 'LastName': 'Tijssen', 'Affiliation': 'Division of Cardiology, Amsterdam UMC Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Robbert J', 'Initials': 'RJ', 'LastName': 'de Winter', 'Affiliation': 'Division of Cardiology, Amsterdam UMC Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Robert K', 'Initials': 'RK', 'LastName': 'Riezebos', 'Affiliation': 'Heart Center, OLVG Hospital, Amsterdam, the Netherlands.'}]",American heart journal,['10.1016/j.ahj.2021.01.001'] 1917,33431374,"Lifestyle Intervention in Pregnant Women With Obesity Impacts Cord Blood DNA Methylation, Which Associates With Body Composition in the Offspring.","Maternal obesity may lead to epigenetic alterations in the offspring and might thereby contribute to disease later in life. We investigated whether a lifestyle intervention in pregnant women with obesity is associated with epigenetic variation in cord blood and body composition in the offspring. Genome-wide DNA methylation was analyzed in cord blood from 208 offspring from the Treatment of Obese Pregnant women (TOP)-study, which includes pregnant women with obesity randomized to lifestyle interventions comprised of physical activity with or without dietary advice versus control subjects (standard of care). DNA methylation was altered at 379 sites, annotated to 370 genes, in cord blood from offspring of mothers following a lifestyle intervention versus control subjects (false discovery rate [FDR] <5%) when using the Houseman reference-free method to correct for cell composition, and three of these sites were significant based on Bonferroni correction. These 370 genes are overrepresented in gene ontology terms, including response to fatty acids and adipose tissue development. Offspring of mothers included in a lifestyle intervention were born with more lean mass compared with control subjects. Methylation at 17 sites, annotated to, for example, DISC1 , GBX2 , HERC2 , and HUWE1 , partially mediates the effect of the lifestyle intervention on lean mass in the offspring (FDR <5%). Moreover, 22 methylation sites were associated with offspring BMI z scores during the first 3 years of life ( P < 0.05). Overall, lifestyle interventions in pregnant women with obesity are associated with epigenetic changes in offspring, potentially influencing the offspring's lean mass and early growth.",2021,"DNA methylation was altered at 379 sites, annotated to 370 genes, in cord blood from offspring of mothers following a lifestyle intervention versus controls ( FDR <5%) when using the Houseman reference-free method to correct for cell composition and three of these sites were significant based on Bonferroni correction.","['pregnant women with obesity randomized to', 'pregnant women with obesity', 'Pregnant Women With Obesity Impacts']","['lifestyle interventions', 'physical activity with or without dietary advice versus controls (standard of care', 'lifestyle intervention', 'Lifestyle Intervention']","['offspring BMI z-scores', 'response to fatty acids and adipose tissue development', 'DNA methylation', 'Cord Blood DNA Methylation', 'lean mass']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0596843', 'cui_str': 'Adipogenesis'}, {'cui': 'C0376452', 'cui_str': 'DNA Methylation'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",,0.0258068,"DNA methylation was altered at 379 sites, annotated to 370 genes, in cord blood from offspring of mothers following a lifestyle intervention versus controls ( FDR <5%) when using the Houseman reference-free method to correct for cell composition and three of these sites were significant based on Bonferroni correction.","[{'ForeName': 'Josefine', 'Initials': 'J', 'LastName': 'Jönsson', 'Affiliation': 'Epigenetics and Diabetes Unit, Department of Clinical Sciences, Lund University Diabetes Centre, Lund University, Scania University Hospital, Malmö, Sweden josefin.jonsson@med.lu.se charlotte.ling@med.lu.se.'}, {'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Renault', 'Affiliation': 'Department of Obstetrics and Gynecology, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'García-Calzón', 'Affiliation': 'Epigenetics and Diabetes Unit, Department of Clinical Sciences, Lund University Diabetes Centre, Lund University, Scania University Hospital, Malmö, Sweden.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Perfilyev', 'Affiliation': 'Epigenetics and Diabetes Unit, Department of Clinical Sciences, Lund University Diabetes Centre, Lund University, Scania University Hospital, Malmö, Sweden.'}, {'ForeName': 'Angela C', 'Initials': 'AC', 'LastName': 'Estampador', 'Affiliation': 'Genetic and Molecular Epidemiology Unit, Department of Clinical Sciences, Lund University Diabetes Centre, Lund University, Malmö, Sweden.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Nørgaard', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Mads Vendelbo', 'Initials': 'MV', 'LastName': 'Lind', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Vaag', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Hjort', 'Affiliation': 'Department of Obstetrics, Center for Pregnant Women with Diabetes, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Kim F', 'Initials': 'KF', 'LastName': 'Michaelsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Emma Malchau', 'Initials': 'EM', 'LastName': 'Carlsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Franks', 'Affiliation': 'Genetic and Molecular Epidemiology Unit, Department of Clinical Sciences, Lund University Diabetes Centre, Lund University, Malmö, Sweden.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Ling', 'Affiliation': 'Epigenetics and Diabetes Unit, Department of Clinical Sciences, Lund University Diabetes Centre, Lund University, Scania University Hospital, Malmö, Sweden josefin.jonsson@med.lu.se charlotte.ling@med.lu.se.'}]",Diabetes,['10.2337/db20-0487'] 1918,33432731,Effectiveness of neonatal emergency nursing education through simulation training: Flipped learning based on Tanner's Clinical Judgement Model.,"AIM To examine the effects of neonatal simulation-based practice by applying flipped learning based on Tanner's clinical judgement model to pre-simulation briefing for nursing students. DESIGN A quasi-experimental non-equivalent control group pre- and postintervention design. METHODS Using Tanner's clinical judgment model, flipped learning was developed and applied to the pre-simulation briefing curriculum prior to the neonatal nursing simulation exercise. Flipped learning was compared with a general pre-simulation briefing with 65 South Korean students. From September 7, 2019, to October 25, 2019. RESULTS The experimental group's critical thinking, self-confidence and clinical judgement ability increased, but knowledge, satisfaction and anxiety did not differ from that of the control group. Pre-simulation briefing design focuses on improving students' environmental comfort and reducing anxiety rather than developing complex reasoning skills and clinical judgement abilities. Applying flipped learning based on Tanner's clinical judgement model to pre-simulation briefing increased critical thinking, self-confidence and clinical judgement ability.",2021,"The experimental group's critical thinking, self-confidence and clinical judgement ability increased, but knowledge, satisfaction and anxiety did not differ from that of the control group.","['nursing students', '65 South Korean students']","['Flipped learning', 'neonatal emergency nursing education', 'neonatal simulation-based practice by applying flipped learning']","['knowledge, satisfaction and anxiety']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0540654', 'cui_str': 'Casper Protein'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0085125', 'cui_str': 'Nursing, Emergency'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1632850', 'cui_str': 'Apply'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.024393,"The experimental group's critical thinking, self-confidence and clinical judgement ability increased, but knowledge, satisfaction and anxiety did not differ from that of the control group.","[{'ForeName': 'Sun-Yi', 'Initials': 'SY', 'LastName': 'Yang', 'Affiliation': 'College of Nursing, Konyang University, Daejeon, Korea.'}]",Nursing open,['10.1002/nop2.748'] 1919,33434303,"Pathways of diabetes distress, decisional balance, self-efficacy and resilience to quality of life in insulin-treated patients with type 2 diabetes: A 9-month prospective study.","AIMS AND OBJECTIVES To construct a path model addressing influences of diabetes distress, self-efficacy of injecting insulin, resilience and decisional balance of injecting insulin to quality of life (QoL) in insulin-treated patients with type 2 diabetes (T2DM). BACKGROUND Insulin regimens more negatively impact QoL than oral medication treatments in patients with T2DM. Understanding the factors and influencing pathways associated with subsequent QoL will help nurses design timely interventions to improve QoL of insulin-treated T2DM patients. DESIGN A 9-month prospective design was employed in this study. METHODS Self-reported questionnaires were used to collect data from 185 insulin-treated T2DM patients. At baseline, diabetes distress and self-efficacy of injecting insulin were collected, while QoL, resilience and decisional balance of injecting insulin were collected 9 months later. Data were collected from February 2017 to February 2018. Structural equation modelling was used for analysis. This study was conducted based on the STROBE. RESULTS Low baseline diabetes distress and high 9-month decisional balance of injecting insulin directly associated with high 9-month QoL. High baseline self-efficacy of injecting insulin and high 9-month resilience directly associated with high 9-month decisional balance of insulin injection and indirectly associated with high 9-month QoL. High baseline diabetes distress directly and indirectly associated with poor 9-month QoL. CONCLUSIONS Diabetes distress, self-efficacy of injecting insulin, resilience and decisional balance of injecting insulin play different roles in associating with QoL in insulin-treated T2DM patients. RELEVANCE TO CLINICAL PRACTICE Nurses could provide educational programs focusing on enhancing decisional balance of injecting insulin to improve QoL in insulin-treated patients. Improving self-efficacy of injecting insulin and resilience could be promising strategies to improve the decisional balance of injecting insulin. More timely assessment of diabetes distress and intervention might be powerful strategies to improve subsequent QoL in these patients.",2021,"RELEVANCE TO CLINICAL PRACTICE Nurses could provide educational programs focusing on enhancing decisional balance of injecting insulin to improve QoL in insulin-treated patients.","['patients with T2DM', 'insulin-treated patients with type 2 diabetes', 'Self-reported questionnaires were used to collect data from 185 insulin-treated T2DM patients', 'Data were collected from February 2017 to February 2018', 'insulin-treated patients with type 2 diabetes (T2DM']",[],"['QoL, resilience, and decisional balance of injecting insulin', 'diabetes distress, self-efficacy of injecting insulin, resilience, and decisional balance of injecting insulin to quality of life (QoL', 'diabetes distress, decisional balance, self-efficacy, and resilience to quality of life', 'diabetes distress and self-efficacy of injecting insulin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4517617', 'cui_str': '185'}]",[],"[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.0223587,"RELEVANCE TO CLINICAL PRACTICE Nurses could provide educational programs focusing on enhancing decisional balance of injecting insulin to improve QoL in insulin-treated patients.","[{'ForeName': 'Hui-Chun', 'Initials': 'HC', 'LastName': 'Hsu', 'Affiliation': ""Lee's Endocrinology Clinic, Pingtung City, Taiwan.""}, {'ForeName': 'Shi-Yu', 'Initials': 'SY', 'LastName': 'Chen', 'Affiliation': 'Tri-Service General Hospital, Taipei City, Taiwan.'}, {'ForeName': 'Yau-Jiunn', 'Initials': 'YJ', 'LastName': 'Lee', 'Affiliation': ""Lee's Endocrinology Clinic, Pingtung City, Taiwan.""}, {'ForeName': 'Wan-Yi', 'Initials': 'WY', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, Shu-Zen Junior College of Medicine and Management, Kaohsiung City, Taiwan.'}, {'ForeName': 'Ruey-Hsia', 'Initials': 'RH', 'LastName': 'Wang', 'Affiliation': 'College of Nursing, Kaohsiung Medical University, Kaohsiung City, Taiwan.'}]",Journal of clinical nursing,['10.1111/jocn.15652'] 1920,33443719,"Effects of Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07 Supplementation on Nutritional and Metabolic Parameters in the Early Postoperative Period after Roux-en-Y Gastric Bypass: a Randomized, Double-Blind, Placebo-Controlled Trial.","Studies have suggested that Roux-en-Y gastric bypass (RYGB) causes changes in the intestinal microbiota composition and function due to anatomical and physiological modifications. The role of probiotic supplementation after bariatric procedures remains to be determined. PURPOSE The aim of this study was to investigate the effects of Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07 supplementation on nutritional and metabolic parameters after RYGB. MATERIALS AND METHODS This is a randomized, double-blind, placebo-controlled clinical trial. Patients were assigned to receive either a probiotic supplement (FloraVantage®) or placebo for three consecutive months, beginning 7 days after surgery. Anthropometric and biochemical indexes were evaluated in the preoperative period and at the end of the study. RESULTS Following RYGB, serum 25-OH vitamin D increased in both groups compared to baseline; however, this increase was significant only in the probiotic group (p = 0.004). Vitamin B 12 levels tended to be higher in the probiotic group compared to the placebo group (p = 0.063), and triglyceride levels showed a significant reduction in the probiotic group only (p < 0.001). In addition, a significant reduction was observed in the anthropometric parameters and glycemic profile (p < 0.05) in both groups. CONCLUSION Probiotic supplementation after RYGB improves the vitamin and lipid profile.",2021,"Vitamin B 12 levels tended to be higher in the probiotic group compared to the placebo group (p = 0.063), and triglyceride levels showed a significant reduction in the probiotic group only (p < 0.001).",['Early Postoperative Period after Roux-en-Y Gastric Bypass'],"['placebo', 'probiotic supplementation', 'Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07 Supplementation', 'probiotic supplement (FloraVantage®) or placebo', 'Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07 supplementation', 'Roux-en-Y gastric bypass (RYGB', 'Placebo']","['nutritional and metabolic parameters', 'Anthropometric and biochemical indexes', 'triglyceride levels', 'serum 25-OH vitamin D', 'anthropometric parameters and glycemic profile', 'Nutritional and Metabolic Parameters', 'vitamin and lipid profile']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C1001866', 'cui_str': 'Bifidobacterium animalis'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}]",,0.154752,"Vitamin B 12 levels tended to be higher in the probiotic group compared to the placebo group (p = 0.063), and triglyceride levels showed a significant reduction in the probiotic group only (p < 0.001).","[{'ForeName': 'Marília Rizzon Zaparolli', 'Initials': 'MRZ', 'LastName': 'Ramos', 'Affiliation': 'UFPR, Curitiba, Brazil. mariliazaparolli@gmail.com.'}, {'ForeName': 'Lígia', 'Initials': 'L', 'LastName': 'de Oliveira Carlos', 'Affiliation': 'UFPR, Curitiba, Brazil.'}, {'ForeName': 'Nathalia Ramori Farinha', 'Initials': 'NRF', 'LastName': 'Wagner', 'Affiliation': 'UFPR, Curitiba, Brazil.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Felicidade', 'Affiliation': 'School of Medicine, Department of Pathology, São Paulo State University (UNESP), São Paulo, Brazil.'}, {'ForeName': 'Magda Ramos', 'Initials': 'MR', 'LastName': 'da Cruz', 'Affiliation': 'Nutrition Course of the Pontifical Catholic University of Paraná (PUCPR), Curitiba, Brazil.'}, {'ForeName': 'Cesar Augusto', 'Initials': 'CA', 'LastName': 'Taconeli', 'Affiliation': 'Department of Statistics, Federal University of Paraná, Curitiba, Brazil.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Fernandes', 'Affiliation': 'Faculty of Health Sciences, Federal University of Grande Dourados, Dourados, Brazil.'}, {'ForeName': 'Alcides José Branco', 'Initials': 'AJB', 'LastName': 'Filho', 'Affiliation': 'Santa Casa de Misericórdia de Curitiba Hospital, Curitiba, Brazil.'}, {'ForeName': 'Antônio Carlos Ligocki', 'Initials': 'ACL', 'LastName': 'Campos', 'Affiliation': 'Post-graduate Program in Clinical Surgery, Surgery Department, Federal University of Parana, Curitiba, Brazil.'}]",Obesity surgery,['10.1007/s11695-021-05222-2'] 1921,33443290,Comparison of use of plaster casting versus elastic bandage following carpal tunnel release: a randomized controlled study.,"OBJECTIVE To compare the effects of two postoperative regimens following carpal tunnel release; plaster casting and elastic bandaging. DESIGN A randomized controlled study. PATIENTS Patients with carpal tunnel syndrome and planned surgical carpal tunnel release were invited to participate. METHODS A total of 94 patients were randomized to either plaster casting or elastic bandaging to be used 2 weeks postoperatively. Muscle strength, pain rated on a visual analogue scale, range of movement, sensibility, oedema, and different scores regarding symptoms and function were measured before and 2, 4, 6, 8 and 26 weeks after surgery. RESULTS No differences were found between the 2 groups for any measurement, except for the DASH (Disability of the Arm, Shoulder and Hand) Health Score and daily function, rated 2 weeks postoperatively, in which the bandage group scored better. Both groups improved significantly over time for all measurements, sensibility was improved after 2 weeks, while strength was not fully recovered until week 26. CONCLUSION Following carpal tunnel release no benefits were found in using plaster casting, compared with elastic bandaging. Among these patients there was more discomfort during plaster casting compared with elastic bandaging; therefore plaster casting is not recommended following this type of surgery.",2021,"No differences were found between the 2 groups for any measurement, except for the Disabilities of the Arm, Shoulder and Hand (DASH) Health score and daily function, rated 2 weeks postoperatively, in which the bandage group scored better.","['carpal tunnel release', 'Patients with carpal tunnel syndrome and planned surgical carpal tunnel release were invited to participate', '94 patients']","['plaster casting or elastic bandaging', 'elastic bandaging', 'plaster casting and elastic bandaging', 'plaster casting']","['Muscle strength, pain rated on a visual analogue scale, range of movement, sensibility, oedema, and different scores regarding symptoms and function', 'Disabilities of the Arm, Shoulder and Hand (DASH) Health score and daily function', 'sensibility was improved [AQ16', 'discomfort']","[{'cui': 'C0196576', 'cui_str': 'Decompression of median nerve'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0460977', 'cui_str': 'Plasters'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0150468', 'cui_str': 'Application of bandage'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0439823', 'cui_str': 'Sensibilities'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",94.0,0.0433927,"No differences were found between the 2 groups for any measurement, except for the Disabilities of the Arm, Shoulder and Hand (DASH) Health score and daily function, rated 2 weeks postoperatively, in which the bandage group scored better.","[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Svegard', 'Affiliation': 'Department of Orthopaedics, Eksjö, Region Jönköping County and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Nordvall Persson', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Zetterlund', 'Affiliation': ''}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Alkner', 'Affiliation': ''}]",Journal of rehabilitation medicine,['10.2340/16501977-2788'] 1922,33449316,Caregivers' Understanding of Informed Consent in a Randomized Control Trial.,"There are differences in caregivers' literacy and health literacy levels that may affect their ability to consent to children participating in clinical research trials. This study aimed to explore the effectiveness, and caregivers' understandings, of the process of informed consent that accompanied their child's participation in a dental randomized control trial (RCT). Telephone interviews were conducted with a convenience sample of ten caregivers who each had a child participating in the RCT. Pre-tested closed and open-ended questions were used, and the findings were produced from an inductive analysis of the latter and a descriptive analysis of the former. Participants had limited understanding of the purpose of the RCT and rated the readability of the consent form more highly than they rated their understanding of the research. All felt that informed consent was vital, but some caregivers had not read the consent documents. Some caregivers enrolled their child in the RCT because they trusted the researchers, and the majority wanted to improve dental care for children. The informed consent process was not always effective despite high readability of the informed consent documents. Researchers must consider the health literacy of the study group, and actively engaging with caregivers to achieve meaningful informed consent may be challenging. Future research could explore participants' perspectives of informed consent in populations with low health literacy and assess whether an underlying expectation not to comprehend health-related information may be a barrier to informed consent.",2021,Participants had limited understanding of the purpose of the RCT and rated the readability of the consent form more highly than they rated their understanding of the research.,['Telephone interviews were conducted with a convenience sample of ten caregivers who each had a child participating in the RCT. Pre-tested closed and open-ended questions'],[],[],"[{'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0282440', 'cui_str': 'Randomized Controlled Trials as Topic'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0444930', 'cui_str': 'End'}]",[],[],10.0,0.0579988,Participants had limited understanding of the purpose of the RCT and rated the readability of the consent form more highly than they rated their understanding of the research.,"[{'ForeName': 'Dorothy Helen', 'Initials': 'DH', 'LastName': 'Boyd', 'Affiliation': 'Faculty of Dentistry, University of Otago, 310 Great King Street, Dunedin, 9016, New Zealand. dorothy.boyd@otago.ac.nz.'}, {'ForeName': 'Yinan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Stratford Dental, 82 Miranda Street, Taranaki, Stratford District, 4332, New Zealand.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Smith', 'Affiliation': 'Wellington Institute of Technology, Private Bag 39803, Wellington Mail Centre, Lower Hutt, 5045, New Zealand.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Adam', 'Affiliation': 'Faculty of Dentistry, University of Otago, 310 Great King Street, Dunedin, 9016, New Zealand.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Foster Page', 'Affiliation': 'Faculty of Dentistry, University of Otago, 310 Great King Street, Dunedin, 9016, New Zealand.'}, {'ForeName': 'W M', 'Initials': 'WM', 'LastName': 'Thomson', 'Affiliation': 'Faculty of Dentistry, University of Otago, 310 Great King Street, Dunedin, 9016, New Zealand.'}]",Journal of bioethical inquiry,['10.1007/s11673-020-10085-w'] 1923,33452108,Improved Cognitive Promotion through Accelerated Magnetic Stimulation.,"Noninvasive brain stimulation to enhance cognition is an area of increasing research interest. Theta burst stimulation (TBS) is a novel accelerated form of stimulation, which more closely mimics the brain's natural firing patterns and may have greater effects on cognitive performance. We report here the comparative assessment of the effect of conventional high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) protocols and TBS protocols on cognition enhancement in healthy controls. Sixty healthy adults (34 males and 26 females) were randomized and counterbalanced and assigned to HF-rTMS ( n  = 20), TBS ( n  = 20), or sham ( n  = 20) groups. The promotion effects of different parameters of prefrontal stimulation on working memory and executive function were compared, as assessed by performance in N-back tasks and the Wisconsin Card Sorting Test (WCST). Both HF-rTMS and intermittent TBS (iTBS) groups displayed a significant improvement in N-back tasks, with an effect size of 0.79 and 1.50, respectively. Furthermore, the iTBS group displayed a significant improvement in the WCST, with an effect size of 0.84. The iTBS group demonstrated higher effect sizes than the HF-rTMS group ( t  =   2.68, p  =   0.011), with an effect size of 0.85. However, no improvement in other tasks was observed ( p  >   0.05). Intermittent TBS has a stronger cognitive promoting effect than conventional rTMS. In summary, our findings provide direct evidence that iTBS may be a superior protocol for cognitive promotion.",2021,"The iTBS group demonstrated higher effect sizes than the HF-rTMS group ( t =2.68, P =0.011), with an effect size of 0.85.","['healthy controls', 'Sixty healthy adults (34 males and 26 females']","['HF-rTMS', '20 Hz rTMS and iTBS', 'HF-rTMS and intermittent TBS (iTBS', 'placebo', 'Theta burst stimulation (TBS', 'TBS', 'conventional high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) protocols and TBS protocols', 'Noninvasive brain stimulation']","['cognition enhancement', 'executive function (cognitive flexibility) performance', 'working memory and executive function']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",60.0,0.139158,"The iTBS group demonstrated higher effect sizes than the HF-rTMS group ( t =2.68, P =0.011), with an effect size of 0.85.","[{'ForeName': 'Xingqi', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, the First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, the First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Geng', 'Affiliation': ""Department of Neurology, Second People's Hospital of Hefei City, The Hefei Affiliated Hospital of Anhui Medical University, Hefei 230022, China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': 'Department of Neurology, the First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Yibing', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Department of Neurology, the First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Chengjuan', 'Initials': 'C', 'LastName': 'Xie', 'Affiliation': 'Department of Neurology, the First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Xingui', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, the First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Gong-Jun', 'Initials': 'GJ', 'LastName': 'Ji', 'Affiliation': 'Department of Neurology, the First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Yanghua', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Department of Neurology, the First Affiliated Hospital of Anhui Medical University, Hefei 230022, China wangkai1964@126.com ayfytyh@126.com.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, the First Affiliated Hospital of Anhui Medical University, Hefei 230022, China wangkai1964@126.com ayfytyh@126.com.'}]",eNeuro,['10.1523/ENEURO.0392-20.2020'] 1924,33452200,Instantaneous wave-free ratio guided multivessel revascularisation during percutaneous coronary intervention for acute myocardial infarction: study protocol of the randomised controlled iMODERN trial.,"INTRODUCTION Recent randomised clinical trials showed benefit of non-culprit lesion revascularisation in ST-elevation myocardial infarction (STEMI) patients. However, it remains unclear whether revascularisation should be performed at the index procedure or at a later stage. METHODS AND ANALYSIS The instantaneous wave-free ratio (iFR) Guided Multivessel Revascularisation During Percutaneous Coronary Intervention for Acute Myocardial Infarction trial is a multicentre, randomised controlled prospective open-label trial with blinded evaluation of endpoints. After successful primary percutaneous coronary intervention (PCI), eligible STEMI patients with residual non-culprit lesions are randomised, to instantaneous wave-free ratio guided treatment of non-culprit lesions during the index procedure versus deferred cardiac MR-guided management within 4 days to 6 weeks. The primary endpoint of the study is the combined occurrence of all-cause death, recurrent myocardial infarction and hospitalisation for heart failure at 12 months follow-up. Clinical follow-up includes questionnaires at 3 months and outpatient visits at 6 months and 12 months after primary PCI. Furthermore, a cost-effectiveness analysis will be performed. ETHICS AND DISSEMINATION Permission to conduct this trial has been granted by the Medical Ethical Committee of the Amsterdam University Medical Centres (loc. VUmc, ID NL60107.029.16). The primary results of this trial will be shared in a main article and subgroup analyses or spin-off studies will be shared in secondary papers. TRIAL REGISTRATION NUMBER NCT03298659.",2021,"The primary endpoint of the study is the combined occurrence of all-cause death, recurrent myocardial infarction and hospitalisation for heart failure at 12 months follow-up.","['ST-elevation myocardial infarction (STEMI) patients', 'acute myocardial infarction', 'After successful primary percutaneous coronary intervention (PCI), eligible STEMI patients with residual non-culprit lesions']","['percutaneous coronary intervention', 'instantaneous wave-free ratio guided treatment of non-culprit lesions during the index procedure versus deferred cardiac MR-guided management', 'Instantaneous wave-free ratio guided multivessel revascularisation', 'instantaneous wave-free ratio (iFR) Guided Multivessel Revascularisation During Percutaneous Coronary Intervention']","['combined occurrence of all-cause death, recurrent myocardial infarction and hospitalisation for heart failure']","[{'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",,0.173306,"The primary endpoint of the study is the combined occurrence of all-cause death, recurrent myocardial infarction and hospitalisation for heart failure at 12 months follow-up.","[{'ForeName': 'Casper W H', 'Initials': 'CWH', 'LastName': 'Beijnink', 'Affiliation': 'Cardiology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Troels', 'Initials': 'T', 'LastName': 'Thim', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus N, Denmark.'}, {'ForeName': 'Dirk Jan', 'Initials': 'DJ', 'LastName': 'van der Heijden', 'Affiliation': 'Cardiology, Medisch Centrum Haaglanden, Den Haag, The Netherlands.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Klem', 'Affiliation': 'Cardiology, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Rasha', 'Initials': 'R', 'LastName': 'Al-Lamee', 'Affiliation': 'Cardiology, Imperial College London Faculty of Medicine, London, UK.'}, {'ForeName': 'Jacqueline L', 'Initials': 'JL', 'LastName': 'Vos', 'Affiliation': 'Cardiology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Koop', 'Affiliation': 'Cardiology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Marcel G W', 'Initials': 'MGW', 'LastName': 'Dijkgraaf', 'Affiliation': 'Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC - Locatie AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Marcel A M', 'Initials': 'MAM', 'LastName': 'Beijk', 'Affiliation': 'Cardiology, Amsterdam UMC Locatie AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Raymond J', 'Initials': 'RJ', 'LastName': 'Kim', 'Affiliation': 'Cardiology, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Davies', 'Affiliation': 'Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Raposo', 'Affiliation': 'Cardiology, Centro Hospitalar de Lisboa Ocidental EPE, Lisboa, Portugal.'}, {'ForeName': 'Sérgio B', 'Initials': 'SB', 'LastName': 'Baptista', 'Affiliation': 'Cardiology Department, Hospital Fernando Fonseca, Amadora, Portugal.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': 'Interventional Cardiology, Hospital Clínico Universitario San Carlos, Madrid, Spain.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Piek', 'Affiliation': 'Cardiology, Amsterdam UMC Locatie AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Maeng', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus N, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Cardiology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Nijveldt', 'Affiliation': 'Cardiology, Radboudumc, Nijmegen, The Netherlands robin@nijveldt.net.'}]",BMJ open,['10.1136/bmjopen-2020-044035'] 1925,33456728,An RCT of acute health effects in COPD-patients after passive vape exposure from e-cigarettes.,"Background : E-cigarette use has been shown to have short-term acute effects among active users but less is known of the acute passive effects, particularly among individuals with existing respiratory diseases. Objective : To investigate local and systemic effects of short-term passive vape exposure among patients with mild or moderate chronic obstructive pulmonary disease (COPD). Methods : In a double-blinded crossover study 16 non-smoking COPD-patients (mean age 68) were randomly exposed for 4 h to passive vape (median PM 2.5 : 18 µg/m 3 (range: 8-333)) and clean air (PM 2.5  < 6 µg/m 3 ) separated by 14 days. Particles were measured using an ultrafine particle counter (P-TRAK) and a scanning mobility particle sizer (SMPS). Health effects including Surfactant Protein-A (SP-A) and albumin in exhaled air, spirometry, FeNO, and plasma proteins were evaluated before, right after, and 24 hours after exposure. Participants reported symptoms throughout exposure sessions. Data were analyzed using mixed models. Results : SP-A in exhaled air was negatively affected by exposure to vape and several plasma proteins increased significantly. Throat irritation was more pronounced during passive vape exposure, while FVC and FEV 1 decreased, however, not significantly. Conclusions: SP-A in exhaled air and some plasma proteins were affected by passive vape in patients with COPD indicating inflammation, showing that passive vape exposure is potentially harmful.",2020,"Throat irritation was more pronounced during passive vape exposure, while FVC and FEV 1 decreased, however, not significantly. ","['16 non-smoking COPD-patients (mean age 68', 'patients with mild or moderate chronic obstructive pulmonary disease (COPD', 'individuals with existing respiratory diseases', 'COPD-patients after passive vape exposure from e-cigarettes', 'patients with COPD indicating inflammation']","['Surfactant Protein-A (SP-A) and albumin', 'short-term passive vape exposure', ' ']","['Throat irritation', 'exhaled air, spirometry, FeNO, and plasma proteins']","[{'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0730605', 'cui_str': 'Moderate chronic obstructive pulmonary disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0035204', 'cui_str': 'Disorder of respiratory system'}, {'cui': 'C0291011', 'cui_str': 'VAPE protocol'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]","[{'cui': 'C0143146', 'cui_str': 'SP-A Protein'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0291011', 'cui_str': 'VAPE protocol'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0700184', 'cui_str': 'Throat irritation'}, {'cui': 'C0225387', 'cui_str': 'Exhaled air'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0032120', 'cui_str': 'Plasma protein'}]",,0.0429683,"Throat irritation was more pronounced during passive vape exposure, while FVC and FEV 1 decreased, however, not significantly. ","[{'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Rosenkilde Laursen', 'Affiliation': 'Environment, Work and Health, Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Jakob Hjort', 'Initials': 'JH', 'LastName': 'Bønløkke', 'Affiliation': 'Environment, Work and Health, Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Bendstrup', 'Affiliation': 'Center for Rare Lung Diseases, Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Bilde', 'Affiliation': 'Department of Chemistry, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Glasius', 'Affiliation': 'Department of Chemistry, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Heitmann Gutzke', 'Affiliation': 'Environment, Work and Health, Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Shamjad', 'Initials': 'S', 'LastName': 'Puthukkadan Moosakutty', 'Affiliation': 'Department of Chemistry, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Anna-Carin', 'Initials': 'AC', 'LastName': 'Olin', 'Affiliation': 'Department of Public Health and Community Medicine, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ravn', 'Affiliation': 'Environment, Work and Health, Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Østergaard', 'Affiliation': 'Environment, Work and Health, Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Sigsgaard', 'Affiliation': 'Environment, Work and Health, Department of Public Health, Aarhus University, Aarhus, Denmark.'}]",European clinical respiratory journal,['10.1080/20018525.2020.1861580'] 1926,33469962,Artificial intelligence against hate: Intervention reducing verbal aggression in the social network environment.,"This article presents a quasi-experimental intervention study designed to reduce the level of verbal aggression on a social networking service (Reddit). The interventions were based on three psychological mechanisms: induction of a descriptive norm, induction of a prescriptive norm, and empathy induction. Each intervention was generated using a communicating bot. Participants exposed to these interventions were compared with a control group that received no intervention. The bot-generated normative communications (both the ones priming descriptive and the ones priming prescriptive norms), as well as the empathizing intervention, reduced the proportion of verbal aggression posted by Reddit accounts. All three interventions proved effective in reducing verbal violence when compared with the control condition.",2021,All three interventions proved effective in reducing verbal violence when compared with the control condition.,[],['Artificial intelligence against hate: Intervention'],"['verbal violence', 'verbal aggression']",[],"[{'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0018616', 'cui_str': 'Feeling hatred'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0424322', 'cui_str': 'Verbal aggression'}]",3.0,0.0124894,All three interventions proved effective in reducing verbal violence when compared with the control condition.,"[{'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Bilewicz', 'Affiliation': 'Faculty of Psychology, University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Patrycja', 'Initials': 'P', 'LastName': 'Tempska', 'Affiliation': 'Samurai Labs, Gdynia, Poland.'}, {'ForeName': 'Gniewosz', 'Initials': 'G', 'LastName': 'Leliwa', 'Affiliation': 'Samurai Labs, Gdynia, Poland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Dowgiałło', 'Affiliation': 'Samurai Labs, Gdynia, Poland.'}, {'ForeName': 'Michalina', 'Initials': 'M', 'LastName': 'Tańska', 'Affiliation': 'Institute of Psychology, Jagiellonian University, Kraków, Poland.'}, {'ForeName': 'Rafał', 'Initials': 'R', 'LastName': 'Urbaniak', 'Affiliation': 'Faculty of Social Sciences, University of Gdańsk, Gdańsk, Poland.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Wroczyński', 'Affiliation': 'Samurai Labs, Gdynia, Poland.'}]",Aggressive behavior,['10.1002/ab.21948'] 1927,33473163,Clinical utility of circulating tumour cell-based monitoring of late-line chemotherapy for metastatic breast cancer: the randomised CirCe01 trial.,"BACKGROUND CirCe01 trial aimed to assess the clinical utility of circulating tumour cell (CTC)-based monitoring in metastatic breast cancer (MBC) patients beyond the third line of chemotherapy (LC). METHODS CirCe01 was a prospective, multicentre, randomised trial (NCT01349842) that included patients with MBC after two systemic LC. Patients with ≥5 CTC/7.5 mL (CellSearch®) were randomised between the CTC-driven and the standard arm. In the CTC arm, changes in CTC count were assessed at the first cycle of each LC; patients in whom CTC levels predicted early tumour progression had to switch to a subsequent LC. RESULTS Greater than or equal to 5 CTC/7.5 mL were observed in N = 101/204 patients. In the CTC arm (N = 51), 43 (83%) and 18 (44%) patients completed CTC monitoring in the third and fourth lines, respectively, and 18 (42%) and 11 (61%) of these patients, respectively, had no CTC response. Thirteen (72%) and 5 (46%) of these patients underwent early switch to the next LC. Overall survival was not different between the two arms (hazard ratio = 0.95, 95% confidence interval = [0.6;1.4], p = 0.8). In subgroup analyses, patients with no CTC response who switched chemotherapy experienced longer survival than patients who did not. CONCLUSIONS Due to the limited accrual and compliance, this trial failed to demonstrate the clinical utility of CTC monitoring. CLINICAL TRIAL REGISTRATION NCT, NCT01349842, https://clinicaltrials.gov/ct2/show/NCT01349842 , registered 9 May 2011.",2021,"Overall survival was not different between the two arms (hazard ratio = 0.95, 95% confidence interval = [0.6;1.4], p = 0.8).","['metastatic breast cancer', 'Patients with ≥5', 'patients with MBC after two systemic LC', 'metastatic breast cancer (MBC) patients beyond the third line of chemotherapy (LC']","['circulating tumour cell-based monitoring of late-line chemotherapy', 'circulating tumour cell (CTC)-based monitoring', 'CTC/7.5', 'mL (CellSearch®']","['longer survival', 'CTC count', 'Overall survival']","[{'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.322912,"Overall survival was not different between the two arms (hazard ratio = 0.95, 95% confidence interval = [0.6;1.4], p = 0.8).","[{'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Cabel', 'Affiliation': 'Department of Medical Oncology, Institut Curie, Paris, France.'}, {'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Berger', 'Affiliation': 'Department of Biostatistics, Institut Curie, PSL Research University, Saint Cloud, France.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Cottu', 'Affiliation': 'Department of Medical Oncology, Institut Curie, Paris, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Loirat', 'Affiliation': 'Department of Medical Oncology, Institut Curie, Paris, France.'}, {'ForeName': 'Aurore', 'Initials': 'A', 'LastName': 'Rampanou', 'Affiliation': 'Circulating Tumor Biomarkers Laboratory, SIRIC2 Institut Curie, Paris, France.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Brain', 'Affiliation': 'Department of Medical Oncology, Institut Curie, Paris, France.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Cyrille', 'Affiliation': 'Department of Biostatistics, Institut Curie, PSL Research University, Saint Cloud, France.'}, {'ForeName': 'Hugues', 'Initials': 'H', 'LastName': 'Bourgeois', 'Affiliation': 'Department of Medical Oncology, Centre Jean Bernard, Le Mans, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Kiavue', 'Affiliation': 'Department of Medical Oncology, Institut Curie, Paris, France.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Deluche', 'Affiliation': 'Department of Medical Oncology, CHU de Limoges, Limoges, France.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Ladoire', 'Affiliation': 'Department of Medical Oncology, CLCC Georges François Leclerc, Dijon, France.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Campone', 'Affiliation': ""Department of Medical Oncology, Institut de cancérologie de l'Ouest, Saint-Herblain, France.""}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Pierga', 'Affiliation': 'Department of Medical Oncology, Institut Curie, Paris, France.'}, {'ForeName': 'Francois-Clement', 'Initials': 'FC', 'LastName': 'Bidard', 'Affiliation': 'Department of Medical Oncology, Institut Curie, Paris, France. fcbidard@curie.fr.'}]",British journal of cancer,['10.1038/s41416-020-01227-3'] 1928,33473017,Chloroquine nasal drops in asymptomatic & mild COVID-19: An exploratory randomized clinical trial.,"Background & objectives : Chloroquine (CQN) administered as nasal drops has the potential to achieve much greater local tissue levels than with oral/systemic administration. This trial was undertaken to study the efficacy and safety profile of topical nasal administration of CQN drops in reducing viral load and preventing clinical progression in early COVID-19 infection. Methods : This randomized clinical trial was done with a sample size of 60. Reverse transcription-polymerase chain reaction (RT-PCR) confirmed asymptomatic patients or those with mild COVID-19 illness [National Early Warning Score (NEWS) =4] were included. Patients were randomized in a 1:1 manner. Control arm (standard supportive treatment, n=30) was compared with intervention arm (n=30) of standard treatment plus CQN eye drops (0.03%) repurposed as nasal drops administered six times daily (0.5 ml/dose) for 10 days. Outcome measures were adverse events and adherence; clinical progression and outcomes were measured by NEWS; sequential RT-PCR cycle threshold (Ct) values were also noted on days 0, 3, 7 and 10. Results : Nasal CQN was associated with local irritation in seven and non-compliance in one of 30 patients. Eleven patients were excluded due to enrolment error (2 - recovered; 9 - false-positive referral), and 49 patients were analyzed as per modified intention-to-treat analysis. Clinical recovery was noted as similar with 100 per cent asymptomatic by day seven in both arms. Virological outcomes also indicated similarly improving Ct values in both arms, and similar proportion of patients transitioning to non-infectivity by day 10 (controls - 19/25; nasal CQN - 15/24). Nine false-positive patients with enrolment error and day 0 RT-PCR negative were initially uninfected but had continuing COVID-19 exposure and treatment as per randomization. Patients receiving nasal CQN (n=5) demonstrated stable Ct values from day 0 to 10, while patients with no nasal CQN (n=4) demonstrated significant dip in Ct value indicating to infection (Ct< 35) and infectivity (Ct< 33). Interpretation & conclusions : The present study suggests to the potential of topical nasal CQN in the prevention of COVID-19 infection if administered before the infection is established. No significant differences in clinical or virological outcome were however, demonstrated in patients with mild but established illness.",2021,"This trial was undertaken to study the efficacy and safety profile of topical nasal administration of CQN drops in reducing viral load and preventing clinical progression in early COVID-19 infection. ","['asymptomatic & mild COVID-19', 'Nine false-positive patients with enrolment error and day 0', 'Eleven patients were excluded due to enrolment error (2 - recovered; 9 - false-positive referral), and 49 patients were analyzed as per modified intention-to-treat analysis']","['standard treatment plus CQN eye drops', 'topical nasal CQN', 'nasal CQN', 'Chloroquine (CQN', 'Chloroquine nasal drops', 'CQN']","['RT-PCR negative', 'stable Ct values', 'clinical or virological outcome', 'Ct value indicating to infection', 'adverse events and adherence; clinical progression and outcomes were measured by NEWS; sequential RT-PCR cycle threshold (Ct) values', 'local tissue levels', 'Ct values', 'Clinical recovery']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0991524', 'cui_str': 'Nasal drops'}]","[{'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0282425', 'cui_str': 'News'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",11.0,0.280042,"This trial was undertaken to study the efficacy and safety profile of topical nasal administration of CQN drops in reducing viral load and preventing clinical progression in early COVID-19 infection. ","[{'ForeName': 'Alok', 'Initials': 'A', 'LastName': 'Thakar', 'Affiliation': 'Department of Otorhinolaryngology & Head & Neck Surgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Smriti', 'Initials': 'S', 'LastName': 'Panda', 'Affiliation': 'Department of Otorhinolaryngology & Head & Neck Surgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Pirabu', 'Initials': 'P', 'LastName': 'Sakthivel', 'Affiliation': 'Department of Otorhinolaryngology & Head & Neck Surgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Megha', 'Initials': 'M', 'LastName': 'Brijwal', 'Affiliation': 'Department of Microbiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Shivram', 'Initials': 'S', 'LastName': 'Dhakad', 'Affiliation': 'Department of Microbiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Avinash', 'Initials': 'A', 'LastName': 'Choudekar', 'Affiliation': 'Department of Microbiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Anupam', 'Initials': 'A', 'LastName': 'Kanodia', 'Affiliation': 'Department of Otorhinolaryngology & Head & Neck Surgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sushma', 'Initials': 'S', 'LastName': 'Bhatnagar', 'Affiliation': 'Department of Oncoanesthesia, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Anant', 'Initials': 'A', 'LastName': 'Mohan', 'Affiliation': 'Department of Pulmonary Medicine & Sleep Disorders, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Subir K', 'Initials': 'SK', 'LastName': 'Maulik', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Lalit', 'Initials': 'L', 'LastName': 'Dar', 'Affiliation': 'Department of Microbiology, All India Institute of Medical Sciences, New Delhi, India.'}]",The Indian journal of medical research,['10.4103/ijmr.IJMR_3665_20'] 1929,33429088,The effect of reducing posttraumatic stress disorder symptoms on cardiovascular risk: Design and methodology of a randomized clinical trial.,"Posttraumatic stress disorder (PTSD) has been associated with accelerated progression of coronary heart disease (CHD). However, the underlying pathophysiological pathway has remained elusive and it is unclear whether there is a direct link between PTSD and CHD risk. This paper describes the methods of a randomized controlled trial developed to examine how changes in PTSD symptoms affect CHD disease pathways. One hundred twenty participants with current PTSD and who are free of known CHD will be randomized to receive either an evidence-based treatment for PTSD (Cognitive Processing Therapy; CPT) or a waitlist control (WL). Before and after CPT/WL, participants undergo assessment of CHD risk biomarkers reflecting autonomic nervous system dysregulation, systemic inflammation, and vascular endothelial dysfunction. The primary hypothesis is that individuals who show improvement in PTSD symptoms will show improvement in CHD risk biomarkers, whereas individuals who fail to improve or show worsening PTSD symptoms will have no change or worsening in CHD biomarkers. This study is expected to provide knowledge of the role of both the direct impact of PTSD symptoms on CHD risk pathways and the role of these systems as candidate mechanisms underlying the relationship between PTSD and CHD risk. Further, results will provide guidance on the utility of cognitive therapy as a tool to mitigate the accelerated progression of CHD in PTSD. Clinical Trials Registration: https://clinicaltrials.gov/ct2/show/NCT02736929; Unique identifier: NCT02736929.",2021,"Before and after CPT/WL, participants undergo assessment of CHD risk biomarkers reflecting autonomic nervous system dysregulation, systemic inflammation, and vascular endothelial dysfunction.","['Posttraumatic stress disorder (PTSD', 'One hundred twenty participants with current PTSD and who are free of known CHD']",['evidence-based treatment for PTSD (Cognitive Processing Therapy; CPT) or a waitlist control (WL'],['CHD risk biomarkers'],"[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C1740791', 'cui_str': 'Evidence based treatment'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1277690', 'cui_str': 'Coronary heart disease risk'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",120.0,0.0349641,"Before and after CPT/WL, participants undergo assessment of CHD risk biomarkers reflecting autonomic nervous system dysregulation, systemic inflammation, and vascular endothelial dysfunction.","[{'ForeName': 'Stefanie T', 'Initials': 'ST', 'LastName': 'LoSavio', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Jean C', 'Initials': 'JC', 'LastName': 'Beckham', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA; Durham VA Healthcare System, Durham, NC, USA.'}, {'ForeName': 'Stephanie Y', 'Initials': 'SY', 'LastName': 'Wells', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA; Durham VA Healthcare System, Durham, NC, USA; VA Mid-Atlantic Mental Illness Research, Education, and Clinical Center, Durham, NC, United States of America.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Resick', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Sherwood', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Cynthia J', 'Initials': 'CJ', 'LastName': 'Coffman', 'Affiliation': 'VA Mid-Atlantic Mental Illness Research, Education, and Clinical Center, Durham, NC, United States of America; Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Healthcare System, Durham, NC, United States of America.'}, {'ForeName': 'Angela C', 'Initials': 'AC', 'LastName': 'Kirby', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA; Durham VA Healthcare System, Durham, NC, USA; VA Mid-Atlantic Mental Illness Research, Education, and Clinical Center, Durham, NC, United States of America.'}, {'ForeName': 'Tiffany A', 'Initials': 'TA', 'LastName': 'Beaver', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA; Durham VA Healthcare System, Durham, NC, USA.'}, {'ForeName': 'Michelle F', 'Initials': 'MF', 'LastName': 'Dennis', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA; Durham VA Healthcare System, Durham, NC, USA.'}, {'ForeName': 'Lana L', 'Initials': 'LL', 'LastName': 'Watkins', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA. Electronic address: lana.watkins@duke.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106269'] 1930,33433317,Evaluation of tofacitinib citrate bioequivalence based on pharmacokinetic parameters in healthy Chinese subjects.,"OBJECTIVE To evaluate the pharmacokinetics and bioequivalence of tofacitinib citrate using pharmacokinetic parameters, a single-dose, randomized-sequence, two-way crossover study of tofacitinib citrate test (T) and reference (R) formulations, with a 4-day washout period, was performed. MATERIALS AND METHODS 72 healthy Chinese subjects were randomly divided into 4 groups: sequence A (TR) and B (RT) in a fasted state and sequence C (TR) and D (RT) in a fed state. Plasma tofacitinib citrate levels were determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS), and the pharmacokinetic parameter maximum concentration (C max ) and area under the concentration-time curve (AUC 0-t and AUC 0-∞ ) were used to evaluate bioequivalence. RESULTS The geometric least-squares mean (GLSM) ratio and 90% confidence intervals for fasted state C max , AUC 0-t , and AUC 0-∞ were 93.90 - 108.17%, 100.41 - 103.95%, and 100.48 - 104.02% and at fed state were 99.45 - 119.52%, 100.05 - 104.23%, and 100.00 - 104.20%, respectively. The 90% CI of the two preparations, C max , AUC 0-t , and AUC 0-∞ , all fell within the equivalent range of 80 - 125%. t max was ~ 0.6 hours later, and C max was ~ 27% lower after a high-fat diet in the fasted state. CONCLUSION Two types of tofacitinib citrate tablets were bioequivalent under both fasted and fed conditions, and both were generally well tolerated; moreover, food-drug interaction may affect drug pharmacokinetics.",2021,"t max was ~ 0.6 hours later, and C max was ~ 27% lower after a high-fat diet in the fasted state. CONCLUSION ","['72 healthy Chinese subjects', 'healthy Chinese subjects']","['tofacitinib citrate test (T) and reference (R) formulations', 'sequence A (TR) and B (RT) in a fasted state and sequence C (TR) and D (RT', 'tofacitinib citrate', 'tofacitinib citrate tablets', 'tofacitinib citrate bioequivalence']","['geometric least-squares mean (GLSM) ratio', 'pharmacokinetic parameter maximum concentration (C max ) and area under the concentration-time curve (AUC 0-t and AUC 0-∞ ', 'Plasma tofacitinib citrate levels']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C2987431', 'cui_str': 'Tofacitinib citrate'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0039789', 'cui_str': 'Equivalencies, Therapeutic'}]","[{'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C2987431', 'cui_str': 'Tofacitinib citrate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",72.0,0.0351427,"t max was ~ 0.6 hours later, and C max was ~ 27% lower after a high-fat diet in the fasted state. CONCLUSION ","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Xiaoru', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Yaru', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Xueyuan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP203751'] 1931,33434852,Impact of bifrontal transcranial Direct Current Stimulation on decision-making and stress reactivity. A pilot study.,"Stress is an adaptive response with repercussions on the human health. The dorsolateral prefrontal cortex (DLPFC) is thought to be involved in stress regulation by contributing to limit its biological and behavioral pejorative consequences. Here, to investigate the contribution of the DLPFC in stress response, we applied transcranial Direct Current Stimulation (tDCS) over the DLPFC during acute stress exposure in healthy participants. We hypothesized that active tDCS compared to sham would impact top-down control of the DLPFC on goal-directed behavior and hypothalamo-pituitary-adrenal (HPA) axis activity. In a double-blind sham-controlled study, 30 healthy subjects were randomly allocated to receive either active (2 mA, n = 15) or sham tDCS (n = 15) with the anode over the left DLPFC and the cathode over the right DLFPC. During the 30-min stimulation period, participants faced an experimental acute stress paradigm. Changes in goal-directed behavior were measured with a decision-making task. HPA axis reactivity was assessed by repeated measures of salivary cortisol. Acute stress decreased appetite for immediate reward in the sham group (mean - 4.40%; p = 0.017) whereas no significant effect of stress was observed in the active group. During stress exposure, we observed a significant larger elevation of salivary cortisol (p = 0.045; Cohen's d = 0.431) in the sham tDCS group (+179.8%; Standard error of the mean (SEM) = 20.6) than in the active group (+138.5%; SEM = 14.2). Stimulating the DLPFC using bifrontal tDCS may prevent stress-induced acute effects on both biological and behavioral outcomes.",2021,Acute stress decreased appetite for immediate reward in the sham group (mean - 4.40%; p = 0.017) whereas no significant effect of stress was observed in the active group.,"['30 healthy subjects', 'healthy participants']","['transcranial Direct Current Stimulation (tDCS', 'active tDCS', 'bifrontal transcranial Direct Current Stimulation', 'active (2\xa0mA, n\xa0=\xa015) or sham tDCS']","['decision-making and stress reactivity', 'elevation of salivary cortisol', 'HPA axis reactivity', 'stress']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0445448', 'cui_str': 'Bifrontal'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C5200800', 'cui_str': 'Hypothalamo-Pituitary-Adrenal Axis'}]",30.0,0.0655343,Acute stress decreased appetite for immediate reward in the sham group (mean - 4.40%; p = 0.017) whereas no significant effect of stress was observed in the active group.,"[{'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Brunelin', 'Affiliation': 'Department of Psychiatry and Neurosciences, Medical School, Université Laval, CERVO Brain Research Center, Centre Intégré Universitaire en Santé et Services Sociaux de La Capitale-Nationale, Quebec City, QC, Canada; Centre Hospitalier Le Vinatier, F69500, Bron, France; INSERM, U1028, CNRS, UMR5292, Lyon Neuroscience Research Center, Psychiatric Disorders: from Resistance to Response-PSYR2 Team, Lyon, France. Electronic address: jerome.brunelin@ch-le-vinatier.fr.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Fecteau', 'Affiliation': 'Department of Psychiatry and Neurosciences, Medical School, Université Laval, CERVO Brain Research Center, Centre Intégré Universitaire en Santé et Services Sociaux de La Capitale-Nationale, Quebec City, QC, Canada.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.12.068'] 1932,33438372,Clinical usefulness of a urine dipstick to detect ethyl glucuronide (EtG): A quantitative clinical study in healthy young female volunteers.,"The metabolite of ethanol, ethyl glucuronide (EtG), reflects alcohol intake longer than ethanol and is used as a biomarker in clinical settings to detect alcohol use. We aimed to assess the clinical usefulness in a low-to-moderate alcohol intake setting and validate a new urine EtG dipstick. A three-way, open, cross-over trial was conducted. Data were collected from January to June 2019. Among 12 healthy female volunteers, we quantified urine EtG and used a dipstick following intake of either one, two or four units of alcohol. Main outcomes were concentrations of EtG in urine and serum, and creatinine and ethanol in serum. EtG in urine was determined dichotomously by dipsticks at two different thresholds and by mass spectrometry used as gold standard. EtG in urine was quantifiable up to 24 hours after alcohol intake. In some individual cases, EtG was quantifiable up to 72 hours at low concentrations. The dipstick detected EtG in urine up to 24 hours. At thresholds of 1000 and 1500 ng/mL, the dipsticks had a specificity of 100% (both), while sensitivity was 84% and 69%, respectively. The sensitivity of the dipsticks was insufficient to support a screening purpose in this setting of low-to-moderate alcohol intake.",2021,"At thresholds of 1,000 and 1,500 ng/mL, the dipsticks had a specificity of 100 % (both), while sensitivity was 84 and 69%, respectively.","['healthy young female volunteers', '12 healthy female volunteers']","['urine dipstick to detect ethyl glucuronide (EtG', 'ethanol, ethyl glucuronide (EtG']","['concentrations of EtG in urine and serum, and creatinine and ethanol in serum']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0441090', 'cui_str': 'Dipstick'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0298229', 'cui_str': 'Ethyl glucuronide'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0298229', 'cui_str': 'Ethyl glucuronide'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]",12.0,0.0194262,"At thresholds of 1,000 and 1,500 ng/mL, the dipsticks had a specificity of 100 % (both), while sensitivity was 84 and 69%, respectively.","[{'ForeName': 'Nete Lundager Klokker', 'Initials': 'NLK', 'LastName': 'Rausgaard', 'Affiliation': 'Department of Gynecology and Obstetrics, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Ravn', 'Affiliation': 'Department of Gynecology and Obstetrics, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Inge Olga', 'Initials': 'IO', 'LastName': 'Ibsen', 'Affiliation': 'Department of Gynecology and Obstetrics, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Palle Bach Nielsen', 'Initials': 'PBN', 'LastName': 'Fruekilde', 'Affiliation': 'Department of Clinical Biochemistry and Pharmacology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Ellen Aagaard', 'Initials': 'EA', 'LastName': 'Nohr', 'Affiliation': 'Department of Gynecology and Obstetrics, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Damkier', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}]",Basic & clinical pharmacology & toxicology,['10.1111/bcpt.13558'] 1933,33440972,A novel balanced anesthesia shortens time to emergence in patients undergoing modified radical mastectomy: a randomized prospective trial.,"BACKGROUND In balanced anesthesia, protocol during the last 30 min is very important to guarantee rapid emergence and smooth extubation. In clinical practice, sevoflurane and propofol are often used in combination to achieve a better anesthetic effect and less adverse reaction. Approximately 30 min before surgical completion, sevoflurane inhalation is often discontinued and propofol is adjusted to keep sufficient depth of anesthesia. However, propofol-based anesthesia may delay time to emergence due to its unpredictable interindividual variability. In contrast, sevoflurane can be rapidly excreted unchanged from the respiratory tract, and more importantly, with minimal variability. This study aimed to investigate the effect of a novel balanced anesthesia protocol, that is propofol-based intravenous induction, propofol-sevoflurane combined maintenance, and total sevoflurane inhalation during the last 30 min of the surgery, on the time to emergence/extubation. METHODS In our study, a total of 100 female patients undergoing modified radical mastectomy were enrolled. All patients received propofol-based intravenous anesthesia for induction followed by propofolsevoflurane combined maintenance. Approximately 30 min before the end of surgery, sevoflurane was continually inhaled without propofol infusion in group Sev (n=50), while propofol was only infused in group Pro (n=50). The primary outcome was the time to emergence/extubation. The second outcomes included time to respiratory recovery, and duration of post-anesthesia care unit (PACU) stay. The hemodynamic parameters and incidences of postoperative adverse events such as hypoxemia, nausea, vomiting, dizziness, and emergence agitation (EA) were also assessed. RESULTS The time to emergence/extubation in group Sev was shorter than that in group Pro (12.74±4.31 vs. 17.74±4.27 min, P<0.0001). Similarly, time to respiratory recovery, and duration of PACU stay were significantly shortened in group Sev (all P<0.0001). Most of the patients in group Sev were extubated under a totally waking state of consciousness. The hemodynamic parameters and incidences of postoperative hypoxemia, nausea, vomiting, dizziness, and EA during the PACU stay were similar between the two groups. CONCLUSIONS In patients undergoing modified radical mastectomy, this novel balanced anesthesia method could shorten the time to emergence/extubation and better waking state without increasing the incidence of adverse events.",2021,"Similarly, time to respiratory recovery, and duration of PACU stay were significantly shortened in group Sev (all P<0.0001).","['100 female patients undergoing', 'patients undergoing', 'patients undergoing modified radical mastectomy']","['sevoflurane inhalation', 'propofol-based anesthesia', 'propofol-based intravenous induction, propofol-sevoflurane combined maintenance, and total sevoflurane inhalation', 'propofol-based intravenous anesthesia for induction followed by propofolsevoflurane combined maintenance', 'propofol', 'sevoflurane', 'modified radical mastectomy', 'sevoflurane and propofol']","['time to emergence/extubation', 'time to respiratory recovery, and duration of PACU stay', 'hemodynamic parameters and incidences of postoperative adverse events such as hypoxemia, nausea, vomiting, dizziness, and emergence agitation (EA', 'time to respiratory recovery, and duration of post-anesthesia care unit (PACU) stay', 'extubated under a totally waking state of consciousness', 'time to emergence/extubation and better waking state', 'hemodynamic parameters and incidences of postoperative hypoxemia, nausea, vomiting, dizziness, and EA during the PACU stay']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002920', 'cui_str': 'Intravenous anesthesia'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0920253', 'cui_str': 'Agitated Emergence'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0009791', 'cui_str': 'Consciousness related finding'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",100.0,0.0437022,"Similarly, time to respiratory recovery, and duration of PACU stay were significantly shortened in group Sev (all P<0.0001).","[{'ForeName': 'Linjia', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology and Perioperative medicine, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Zhenfeng', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology and Perioperative medicine, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Sibi', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology and Perioperative medicine, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiuhong', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology and Perioperative medicine, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ni', 'Affiliation': 'Department of Anesthesiology and Perioperative medicine, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China. niyan812@njmu.edu.cn.'}]",Annals of palliative medicine,['10.21037/apm-20-1774'] 1934,33443879,A Comparative Study of Three-Dimensional Simulation in Nonsurgical Rhinoplasty With Hyaluronic Acid Fillers.,"BACKGROUND The use of 3-dimensional computer imaging has grown steadily over the past decade, especially with cosmetic facial surgery. The technological advance has influenced how we counsel patients, perform procedures, and assess outcomes. The purpose of this study was to analyze the feasibility of quantifying simulated versus actual outcomes for nonsurgical rhinoplasty with hyaluronic acid. METHODS A retrospective review of 3-dimensional images (LifeViz Inc, France) for rhinoplasty patients was performed. Randomized preoperative, simulated, and actual images were rated by a blinded panel of physicians (1 = poor, 5 = excellent). In addition, a quantitative assessment of nasofrontal angle and nasolabial angle was conducted where paired and 2-sample t tests were performed (P < 0.05 as significant). RESULTS Twenty-five patients were included in this comparison study. Fifty-six percent of preoperative images were rated as poor (mean, 1.7). The simulation received a mean score of 3.4 (good in 60% of cases), and 80% of actual cases were rated good to excellent (mean, 3.7). Mean nasofrontal angle decreased from 147.1 ± 1.2° preinjection to 143.3 ± 1.6° posttreatment, a mean change of 3.8 ± 2.0°. The mean nasolabial angle decreased from 125.5 ± 1.6° pretreatment to 117.5 ± 1.5° posttreatment. Average volume of actual dosage was 1.74 ± 0.18 mL. CONCLUSION Three-dimensional simulation for patients undergoing nonsurgical rhinoplasty is helpful for surgical planning and patient communications. It provides a mechanism for critical self-evaluation and helps set patients with realistic expectations about rhinoplasty.",2021,The mean nasolabial angle decreased from 125.5 ± 1.6° pretreatment to 117.5 ± 1.5° posttreatment.,['Twenty-five patients'],"['hyaluronic acid', '3-dimensional images (LifeViz Inc, France', 'Hyaluronic Acid Fillers']","['quantitative assessment of nasofrontal angle and nasolabial angle', 'Mean nasofrontal angle', 'mean nasolabial angle']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0729441', 'cui_str': 'Filler'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0429143', 'cui_str': 'Nasolabial angle'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",25.0,0.0261471,The mean nasolabial angle decreased from 125.5 ± 1.6° pretreatment to 117.5 ± 1.5° posttreatment.,"[{'ForeName': 'Chuhsin', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': ""From the Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.""}, {'ForeName': 'Junjun', 'Initials': 'J', 'LastName': 'He', 'Affiliation': ""Department of Plastic Surgery, Shenzhen Hospital, Peking University, Shenzhen, People's Republic of China.""}, {'ForeName': 'Zhezhen', 'Initials': 'Z', 'LastName': 'Xiong', 'Affiliation': ""From the Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.""}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Xue', 'Affiliation': ""From the Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.""}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': ""From the Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.""}]",Annals of plastic surgery,['10.1097/SAP.0000000000002637'] 1935,33350762,Effectiveness of dose-escalated topiramate monotherapy and add-on therapy in neurosurgery-related epilepsy: A prospective study.,"BACKGROUND Lesional and symptomatic causes of epilepsy are the most common neurological disorders of the brain. Topiramate effectively controls newly diagnosed epilepsy and refractory focal seizures, but high-dose topiramate does not improve seizure control. This study aimed to evaluate the clinical efficacy and safety of dose-escalated topiramate as first-line monotherapy and add-on therapy in patients with neurosurgery-related epilepsy. MATERIAL AND METHODS A total of 55 neurosurgical patients with epilepsy were divided into monotherapy and add-on therapy groups and both groups received topiramate via the dose-escalation method. The primary efficacy outcomes were seizure-free rate and seizure response rate. Adverse events and seizure frequency were recorded. RESULTS The seizure response rate in the first month of monotherapy was significantly better than that of add-on therapy (89% vs 65%, P < .05), but no significant differences were found in seizure response rates between the 2 groups after 2 months of treatment. Both monotherapy and add-on therapy were effective in controlling seizures, with mean seizure frequency of 0.725 vs 0.536 and seizure-free rate of 88% vs 78.6%. Both treatments showed good improvement of seizure frequency in patients without tumor. The efficacy of monotherapy was better than that of add-on therapy (80% vs 29.2%) in patients with body mass index (BMI) ≤24. However, add-on therapy was better than monotherapy (76.7% vs 21.4%) in patients with BMI > 24. Dizziness (25.5%) and headache (16.4%) were the most common adverse events. No severe adverse event such as cognitive impairment was observed. CONCLUSIONS Dose-escalated topiramate monotherapy and add-on therapy demonstrate good efficacy and safety, with fewer adverse events in seizure control in neurosurgical patients.",2020,Dizziness (25.5%) and headache (16.4%) were the most common adverse events.,"['neurosurgical patients', 'neurosurgery-related epilepsy', 'patients with neurosurgery-related epilepsy', '55 neurosurgical patients with epilepsy']","['dose-escalated topiramate monotherapy', 'topiramate', 'Topiramate', 'monotherapy']","['seizure response rate', 'Adverse events and seizure frequency', 'seizure control', 'clinical efficacy and safety', 'seizure-free rate and seizure response rate', 'seizure frequency', 'Dizziness', 'seizure response rates', 'headache', 'severe adverse event such as cognitive impairment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}]","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0076829', 'cui_str': 'topiramate'}]","[{'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1299590', 'cui_str': 'Seizure free'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]",55.0,0.077837,Dizziness (25.5%) and headache (16.4%) were the most common adverse events.,"[{'ForeName': 'Yu-Tse', 'Initials': 'YT', 'LastName': 'Liu', 'Affiliation': 'Department of Neurosurgery, Chang Gung Memorial Hospital, Linkou Branch and school of medicine.'}, {'ForeName': 'Guo-Tai', 'Initials': 'GT', 'LastName': 'Chen', 'Affiliation': 'Department of Neurosurgery, Chang Gung Memorial Hospital, Chiayi Branch and school of medicine, Chang Gung University, Taiwan.'}, {'ForeName': 'Yin-Cheng', 'Initials': 'YC', 'LastName': 'Huang', 'Affiliation': 'Department of Neurosurgery, Chang Gung Memorial Hospital, Linkou Branch and school of medicine.'}, {'ForeName': 'Jih-Tsun', 'Initials': 'JT', 'LastName': 'Ho', 'Affiliation': 'Department of Neurosurgery, Chang Gung Memorial Hospital, Kaohsiung Branch and school of medicine.'}, {'ForeName': 'Cheng-Chi', 'Initials': 'CC', 'LastName': 'Lee', 'Affiliation': 'Department of Neurosurgery, Chang Gung Memorial Hospital, Linkou Branch and school of medicine.'}, {'ForeName': 'Cheng-Chia', 'Initials': 'CC', 'LastName': 'Tsai', 'Affiliation': 'Department of Neurosurgery, Chang Gung Memorial Hospital, Chiayi Branch and school of medicine, Chang Gung University, Taiwan.'}, {'ForeName': 'Chen-Nen', 'Initials': 'CN', 'LastName': 'Chang', 'Affiliation': 'Department of Neurosurgery, Chang Gung Memorial Hospital, Chiayi Branch and school of medicine, Chang Gung University, Taiwan.'}]",Medicine,['10.1097/MD.0000000000023771'] 1936,33450074,"When the Label Does Not Match the Content of a Trial: ""Well-Being Therapy"" in Posttraumatic Stress Disorder: Commentary on Radstaak et al. (2020).","Radstaak, Hüning, and Bohlmeijer (2020) reported on a randomized controlled trial (RCT) of well-being therapy (WBT) compared to treatment as usual (TAU) in the treatment of residual posttraumatic stress disorder (PTSD) symptoms. No significant differences emerged between treatment conditions. However, our view is that what the authors labeled as WBT did not match the manualized psychotherapeutic strategy, and what was defined as TAU was actually an active control group. Further methodological limitations hinder the interpretation of results and make it difficult to draw conclusions from the study. Radstaak et al. (2020) deserve credit for addressing the vexing and neglected problem of residual symptoms in PTSD. However, the role of WBT in PTSD treatment still needs to be explored via an effectively designed RCT. Given that WBT does not require exposure to a patient's index traumatic event as a means of alleviating PTSD symptoms, WBT may represent a promising alternative to current treatments of PTSD.",2021,No significant differences emerged between treatment conditions.,"['Posttraumatic Stress Disorder', 'residual posttraumatic stress disorder (PTSD) symptoms']","['WBT', 'well-being therapy (WBT']",[],"[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.0244766,No significant differences emerged between treatment conditions.,"[{'ForeName': 'Giovanni A', 'Initials': 'GA', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, University at Buffalo, State University of New York, Buffalo, New York, USA.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Guidi', 'Affiliation': 'Department of Psychology, University of Bologna, Italy.'}]",Journal of traumatic stress,['10.1002/jts.22648'] 1937,33449919,The role of GLP-1 in the postprandial effects of acarbose in type 2 diabetes.,"Aims The alpha-glucosidase inhibitor acarbose is believed to reduce plasma glucose by delaying hydrolysis of carbohydrates. Acarbose-induced transfer of carbohydrates to the distal parts of the intestine increases circulating glucagon-like peptide 1 (GLP-1). Using the GLP-1 receptor antagonist exendin(9-39)NH2, we investigated the effect of acarbose-induced GLP-1 secretion on postprandial glucose metabolism in patients with type 2 diabetes. Methods In a double-blinded, placebo-controlled, randomized, crossover study, 15 participants with metformin-treated type 2 diabetes (age: 57-85 years, HbA1c: 40-74 mmol/mol) were subjected to two 14-day treatment periods with acarbose or placebo, respectively, separated by a 6-week wash-out period. At the end of each period, two randomized 4-h liquid mixed meal tests with concomitant infusion of exendin(9-39)NH2 and saline, respectively, were performed. Results Compared to placebo, acarbose increased postprandial GLP-1 concentrations and decreased postprandial glucose. We observed no absolute difference in the exendin(9-39)NH2-induced increase in postprandial glucose excursions between placebo and acarbose periods, but relatively, postprandial glucose was increased by 119 ± 116% (mean ± s.d.) during exendin(9-39)NH2 infusion in the acarbose period vs a 39 ± 27% increase during the placebo period (P = 0.0163). Conclusions We confirm that acarbose treatment stimulates postprandial GLP-1 secretion in patients with type 2 diabetes. Using exendin(9-39)NH2, we did not see an impact of acarbose-induced GLP-1 secretion on absolute measures of postprandial glucose tolerance, but relatively, the effect of exendin(9-39)NH2 was most pronounced during acarbose treatment.",2021,"We observed no absolute difference in the exendin(9-39)NH2-induced increase in postprandial glucose excursions between placebo and acarbose periods, but relatively, postprandial glucose was increased by 119 ± 116% (mean ± SD) during exendin(9-39)NH2 infusion in the acarbose period vs. a 39 ± 27% increase during the placebo period (p = 0.0163). ","['type 2 diabetes', '15 participants with metformin-treated type 2 diabetes (Age 57-85 years, HbA1c 40-74 mmol/mol', 'patients with type 2 diabetes']","['Acarbose', 'acarbose or placebo', 'placebo', 'placebo, acarbose', 'acarbose', 'acarbose-induced GLP-1 secretion']","['postprandial glucose metabolism', 'postprandial glucose', 'postprandial GLP-1 secretion', 'postprandial GLP-1 concentrations', 'postprandial glucose tolerance', 'postprandial glucose excursions']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0050393', 'cui_str': 'Acarbose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0036536', 'cui_str': 'secretion'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]",15.0,0.146263,"We observed no absolute difference in the exendin(9-39)NH2-induced increase in postprandial glucose excursions between placebo and acarbose periods, but relatively, postprandial glucose was increased by 119 ± 116% (mean ± SD) during exendin(9-39)NH2 infusion in the acarbose period vs. a 39 ± 27% increase during the placebo period (p = 0.0163). ","[{'ForeName': 'Niels B', 'Initials': 'NB', 'LastName': 'Dalsgaard', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Lærke S', 'Initials': 'LS', 'LastName': 'Gasbjerg', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Hansen', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Nina L', 'Initials': 'NL', 'LastName': 'Hansen', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Stensen', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Bolette', 'Initials': 'B', 'LastName': 'Hartmann', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens F', 'Initials': 'JF', 'LastName': 'Rehfeld', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}]",European journal of endocrinology,['10.1530/EJE-20-1121'] 1938,33452434,"Efficacy and safety of transcranial direct current stimulation as an add-on treatment for obsessive-compulsive disorder: a randomized, sham-controlled trial.","Obsessive-compulsive disorder (OCD) is a frequent, disabling disorder with high rates of treatment resistance. Transcranial direct current stimulation (tDCS) is a safe, tolerable noninvasive neuromodulation therapy with scarce evidence for OCD. This double-blind, randomized, and sham-controlled study investigates the efficacy of tDCS as add-on treatment for treatment-resistant OCD (failure to respond to at least one previous pharmacological treatment). On 20 consecutive weekdays (4 weeks), 43 patients with treatment-resistant OCD underwent 30 min active or sham tDCS sessions, followed by a 8 week follow-up. The cathode was positioned over the supplementary motor area (SMA) and the anode over the left deltoid. The primary outcome was the change in baseline Y-BOCS score at week 12. Secondary outcomes were changes in mood and anxiety and the occurrence of adverse events. Response was evaluated considering percent decrease of baseline Y-BOCS scores and the Improvement subscale of the Clinical Global Impression (CGI-I) between baseline and week 12. Patients that received active tDCS achieved a significant reduction of OCD symptoms than sham, with mean (SD) Y-BOCS score changes of 6.68 (5.83) and 2.84 (6.3) points, respectively (Cohen's d: 0.62 (0.06-1.18), p = 0.03). We found no between-group differences in responders (four patients in the active tDCS and one in the sham group). Active tDCS of the SMA was not superior to sham in reducing symptoms of depression or anxiety. Patients in both groups reported mild adverse events. Our results suggest that cathodal tDCS over the SMA is an effective add-on strategy in treatment-resistant OCD.",2021,We found no between-group differences in responders (four patients in the active tDCS and one in the sham group).,"['obsessive-compulsive disorder', '43 patients with treatment-resistant OCD underwent']","['SMA', '30\u2009min active or sham tDCS sessions', 'active tDCS', 'tDCS', 'Transcranial direct current stimulation (tDCS', 'transcranial direct current stimulation']","['mild adverse events', 'Efficacy and safety', 'OCD symptoms', 'symptoms of depression or anxiety', 'changes in mood and anxiety and the occurrence of adverse events', 'Obsessive-compulsive disorder (OCD', 'baseline Y-BOCS scores and the Improvement subscale of the Clinical Global Impression (CGI-I', 'change in baseline Y-BOCS score']","[{'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}]","[{'cui': 'C3496174', 'cui_str': 'Supplementary Motor Area'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",43.0,0.346696,We found no between-group differences in responders (four patients in the active tDCS and one in the sham group).,"[{'ForeName': 'Renata de Melo Felipe da', 'Initials': 'RMFD', 'LastName': 'Silva', 'Affiliation': 'Obsessive-Compulsive Spectrum Disorders Program, Laboratory of Psychopathology and Psychiatric Treatment (LIM-23), Department and Institute of Psychiatry, Hospital das Clínicas, University of São Paulo School of Medicine, Ovidio Pires de Campos, 785/3, São Paulo, 05403-000, Brazil. renatamelof@gmail.com.'}, {'ForeName': 'Andre R', 'Initials': 'AR', 'LastName': 'Brunoni', 'Affiliation': 'Department of Interdisciplinary Neuromodulation, Laboratory of Neurosciences, National Institute of Biomarkers in Psychiatry, University of São Paulo School of Medicine, Ovidio Pires de Campos, 785/3, São Paulo, 05403-000, Brazil.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Goerigk', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Ludwig Maximilians University, Munich, Germany.'}, {'ForeName': 'Marcelo Camargo', 'Initials': 'MC', 'LastName': 'Batistuzzo', 'Affiliation': 'Obsessive-Compulsive Spectrum Disorders Program, Laboratory of Psychopathology and Psychiatric Treatment (LIM-23), Department and Institute of Psychiatry, Hospital das Clínicas, University of São Paulo School of Medicine, Ovidio Pires de Campos, 785/3, São Paulo, 05403-000, Brazil.'}, {'ForeName': 'Daniel Lucas da Conceição', 'Initials': 'DLDC', 'LastName': 'Costa', 'Affiliation': 'Obsessive-Compulsive Spectrum Disorders Program, Laboratory of Psychopathology and Psychiatric Treatment (LIM-23), Department and Institute of Psychiatry, Hospital das Clínicas, University of São Paulo School of Medicine, Ovidio Pires de Campos, 785/3, São Paulo, 05403-000, Brazil.'}, {'ForeName': 'Juliana Belo', 'Initials': 'JB', 'LastName': 'Diniz', 'Affiliation': 'Obsessive-Compulsive Spectrum Disorders Program, Laboratory of Psychopathology and Psychiatric Treatment (LIM-23), Department and Institute of Psychiatry, Hospital das Clínicas, University of São Paulo School of Medicine, Ovidio Pires de Campos, 785/3, São Paulo, 05403-000, Brazil.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Padberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Ludwig Maximilians University, Munich, Germany.'}, {'ForeName': 'Giordano', 'Initials': 'G', 'LastName': ""D'Urso"", 'Affiliation': 'Unit of Psychiatry and Psychology, Laboratory of Neuromodulation, Department of Neuroscience, Reproductive Science and Odontostomatology, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Eurípedes Constantino', 'Initials': 'EC', 'LastName': 'Miguel', 'Affiliation': 'Obsessive-Compulsive Spectrum Disorders Program, Laboratory of Psychopathology and Psychiatric Treatment (LIM-23), Department and Institute of Psychiatry, Hospital das Clínicas, University of São Paulo School of Medicine, Ovidio Pires de Campos, 785/3, São Paulo, 05403-000, Brazil.'}, {'ForeName': 'Roseli Gedanke', 'Initials': 'RG', 'LastName': 'Shavitt', 'Affiliation': 'Obsessive-Compulsive Spectrum Disorders Program, Laboratory of Psychopathology and Psychiatric Treatment (LIM-23), Department and Institute of Psychiatry, Hospital das Clínicas, University of São Paulo School of Medicine, Ovidio Pires de Campos, 785/3, São Paulo, 05403-000, Brazil.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00928-w'] 1939,33458763,Safety and efficacy of omadacycline by BMI categories and diabetes history in two Phase III randomized studies of patients with acute bacterial skin and skin structure infections.,"OBJECTIVES The objectives of this post-hoc analysis were to examine the safety and efficacy of omadacycline by BMI categories and diabetes history in adults with acute bacterial skin and skin structure infections (ABSSSI) from two pivotal Phase III studies. PATIENTS AND METHODS OASIS-1 (ClinicalTrials.gov identifier NCT02378480): patients were randomized 1:1 to IV omadacycline or linezolid for 7-14 days, with optional transition to oral medication. OASIS-2 (ClinicalTrials.gov identifier NCT02877927): patients received once-daily oral omadacycline or twice-daily oral linezolid for 7-14 days. Early clinical response (ECR) was defined as ≥20% reduction in lesion size 48-72 h after the first dose. Clinical success at post-treatment evaluation (PTE; 7-14 days after the last dose) was defined as symptom resolution such that antibacterial therapy was unnecessary. Safety was assessed by treatment-emergent adverse events and laboratory measures. Between-treatment comparisons were made with regard to WHO BMI categories and diabetes history. RESULTS Patients were evenly distributed among healthy weight, overweight and obese groups. Clinical success for omadacycline-treated patients at ECR and PTE was similar across BMI categories. Outcomes by diabetes status were similar in omadacycline- and linezolid-treated patients: at ECR, clinical success rates were lower for those with diabetes; at PTE, clinical success was similar between treatment groups regardless of diabetes history. The safety of omadacycline and linezolid was largely similar across BMI groups and by diabetes history. CONCLUSIONS Omadacycline efficacy in patients with higher BMI and in patients with diabetes was consistent with results from two pivotal Phase III ABSSSI trials. Fixed-dose omadacycline is an appropriate treatment for ABSSSI in adults regardless of BMI.",2021,"Outcomes by diabetes status were similar in omadacycline- and linezolid-treated patients: at ECR, clinical success rates were lower for those with diabetes; at PTE, clinical success was similar between treatment groups regardless of diabetes history.","['Patients were evenly distributed among healthy weight, overweight and obese groups', 'patients with acute bacterial skin and skin structure infections', 'adults with acute bacterial skin and skin structure infections (ABSSSI', 'patients with higher BMI and in patients with diabetes']","['omadacycline and linezolid', 'once-daily oral omadacycline or twice-daily oral linezolid', 'omadacycline', 'IV omadacycline or linezolid']","['Early clinical response (ECR', 'Clinical success', 'Safety', 'clinical success rates', 'Safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4552481', 'cui_str': 'Acute bacterial skin and skin structure infection'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4552483', 'cui_str': 'ABSSSI'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C2983838', 'cui_str': 'omadacycline'}, {'cui': 'C0663241', 'cui_str': 'linezolid'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0432594,"Outcomes by diabetes status were similar in omadacycline- and linezolid-treated patients: at ECR, clinical success rates were lower for those with diabetes; at PTE, clinical success was similar between treatment groups regardless of diabetes history.","[{'ForeName': 'Manjunath P', 'Initials': 'MP', 'LastName': 'Pai', 'Affiliation': 'Department of Clinical Pharmacy, College of Pharmacy, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Wilcox', 'Affiliation': 'University of Leeds & Leeds Teaching Hospitals, Leeds LS2 9JT, UK.'}, {'ForeName': 'Surya', 'Initials': 'S', 'LastName': 'Chitra', 'Affiliation': 'Paratek Pharmaceuticals, Inc., King of Prussia, PA 19406, USA.'}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'McGovern', 'Affiliation': 'Paratek Pharmaceuticals, Inc., King of Prussia, PA 19406, USA.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkaa558'] 1940,33460579,A feasibility study for CODE-MI: High-sensitivity cardiac troponin-Optimizing the diagnosis of acute myocardial infarction/injury in women.,"BACKGROUND CODE-MI is a pan-Canadian, multicentre, stepped-wedge, cluster randomized trial that evaluates the impact of using the female-specific 99th percentile threshold for high-sensitivity cardiac troponin (hs-cTn) on the diagnosis, treatment and outcomes of women presenting to the emergency department (ED) with symptoms suggestive for myocardial ischemia. A feasibility study was conducted to estimate the number of eligible patients, the rate of the study's primary outcome under control conditions, and the statistical power to detect a clinically important difference in the primary outcome. METHODS Using linked administrative data from 11 hospitals in Ontario, Canada, from October 2014 to September 2017, the following estimates were obtained: number of women presenting to the ED with symptoms suggestive of myocardial ischemia and a 24-hour peak hs-cTn value within the female-specific and overall thresholds (ie, primary cohort); the rate of the 1-year composite outcome of all-cause mortality, re-admission for nonfatal myocardial infarction, incident heart failure, or emergent/urgent coronary revascularization. Study power was evaluated via simulations. RESULTS Overall, 2,073,849 ED visits were assessed. Among women, chest pain (with or without cardiac features) and shortness of breath were the most common complaints associated with a diagnosis of acute coronary syndrome. An estimated 7.7% of women with these complaints are eligible for inclusion in the primary cohort. The rate of the 1-year outcome in the primary cohort varied significantly across hospitals with a median rate of 12.2% (95%CI: 7.9%-17.7%). With 30 hospitals, randomized at 5-month intervals in 5 steps, approximately 19,600 women are expected to be included in CODE-MI, resulting in >82% power to detect a 20% decrease in the odds of the primary outcome at a 0.05 significance level. CONCLUSIONS This feasibility study greatly enhanced the design of CODE-MI, allowed accurate evaluation of the study power, and demonstrated the strength of using linked administrative health data to guide the design of pragmatic clinical trials.",2021,The rate of the 1-year outcome in the primary cohort varied significantly across hospitals with a median rate of 12.2% (95%CI: 7.9%-17.7%).,"['women presenting to the emergency department (ED) with symptoms suggestive for myocardial ischemia', 'Using linked administrative data from 11 hospitals in Ontario, Canada, from October 2014 to September 2017, the following estimates were obtained: number of women presenting to the ED with symptoms suggestive of myocardial ischemia and a 24-hour peak hs-cTn value within the female-specific and overall thresholds (i.e. primary cohort); the', 'Women']",['CODE-MI'],"['rate of the 1-year outcome', 'rate of the 1-year composite outcome of all-cause mortality, re-admission for non-fatal myocardial infarction, incident heart failure, or emergent/urgent coronary revascularization']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332299', 'cui_str': 'Suggestive of'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1292785', 'cui_str': 'Administrative action'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0009219', 'cui_str': 'Coding'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}]",,0.273224,The rate of the 1-year outcome in the primary cohort varied significantly across hospitals with a median rate of 12.2% (95%CI: 7.9%-17.7%).,"[{'ForeName': 'Yinshan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Population Data BC, Vancouver, Canada. Electronic address: yinshan@mail.ubc.ca.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Sivaswamy', 'Affiliation': 'ICES, Toronto, Canada.'}, {'ForeName': 'May K', 'Initials': 'MK', 'LastName': 'Lee', 'Affiliation': 'Centre for Improved Cardiovascular Health at Centre for Health Evaluation and Outcome Sciences, Vancouver, Canada.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Izadnegahdar', 'Affiliation': 'Division of Cardiology, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Chu', 'Affiliation': 'ICES, Toronto, Canada; University of Toronto, Toronto, Canada.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Ferreira-Legere', 'Affiliation': 'ICES, Toronto, Canada.'}, {'ForeName': 'Karin H', 'Initials': 'KH', 'LastName': 'Humphries', 'Affiliation': 'Centre for Improved Cardiovascular Health at Centre for Health Evaluation and Outcome Sciences, Vancouver, Canada; Division of Cardiology, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Jacob A', 'Initials': 'JA', 'LastName': 'Udell', 'Affiliation': ""ICES, Toronto, Canada; University of Toronto, Toronto, Canada; Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre, Toronto General Hospital, Toronto, Canada.""}]",American heart journal,['10.1016/j.ahj.2021.01.008'] 1941,33438529,Improving Botulinum Toxin Efficiency in Treating Post-Stroke Spasticity Using 3D Innervation Zone Imaging.,"Spasticity is a common post-stroke syndrome that imposes significant adverse impacts on patients and caregivers. This study aims to improve the efficiency of botulinum toxin (BoNT) in managing spasticity, by utilizing a three-dimensional innervation zone imaging (3DIZI) technique based on high-density surface electromyography (HD-sEMG) recordings. Stroke subjects were randomly assigned to two groups: the control group ([Formula: see text]) which received standard ultrasound-guided injections, and the experimental group ([Formula: see text]) which received 3DIZI-guided injections. The amount of BoNT given was consistent for all subjects. The Modified Ashworth Scale (MAS), compound muscle action potential (CMAP) and muscle activation volume (MAV) from bilateral biceps brachii muscles were obtained at the baseline, 3 weeks, and 3 months after injection. Intra-group and inter-group comparisons of MAS, CMAP amplitude and MAV were performed. An overall improvement in MAS of spastic elbow flexors was observed during the 3-week visit ([Formula: see text]), yet no statistically significant difference found with intra-group or inter-group analysis. Compared to the baseline, a significant reduction of CMAP amplitude and MAV were observed in the spastic biceps muscles of both groups at 3-week post-injection, and returned to approximate baseline value at 12-week post injection. A significantly higher reduction was found in CMAP amplitude ([Formula: see text]% versus [Formula: see text]%, [Formula: see text]) and MAV ([Formula: see text]% versus [Formula: see text]%, [Formula: see text]) in the experimental group compared to the control group. The study has demonstrated preliminary evidence that precisely directing BoNT to the innervation zones (IZs) localized by 3DIZI leads to a significantly higher treatment efficiency improvement in spasticity management. Results have also shown the feasibility of developing a personalized BoNT injection technique for the optimization of clinical treatment for post-stroke spasticity using proposed 3DIZI technique.",2021,"Compared to the baseline, a significant reduction of CMAP amplitude and MAV were observed in the spastic biceps muscles of both groups at 3-week post-injection, and returned to approximate baseline value at 12-week post injection.",['Stroke subjects'],"['botulinum toxin (BoNT', 'control group ([Formula: see text]) which received standard ultrasound-guided injections, and the experimental group ([Formula: see text]) which received 3DIZI-guided injections']","['MAS, CMAP amplitude and MAV', 'CMAP amplitude and MAV', 'CMAP amplitude', 'Modified Ashworth Scale (MAS), compound muscle action potential (CMAP) and muscle activation volume (MAV) from bilateral biceps brachii muscles', 'MAS of spastic elbow flexors']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0006055', 'cui_str': 'botulinum toxin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0522028', 'cui_str': 'Muscle action potential'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}]",,0.0256697,"Compared to the baseline, a significant reduction of CMAP amplitude and MAV were observed in the spastic biceps muscles of both groups at 3-week post-injection, and returned to approximate baseline value at 12-week post injection.","[{'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Biomedical Engineering, University of Houston, Houston, TX, USA.'}, {'ForeName': 'Yen-Ting', 'Initials': 'YT', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Texas Health Science Center at Houston and TIRR, Memorial Hermann Hospital, Houston, TX, USA.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Biomedical Engineering, University of Houston, Houston, TX, USA.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Magat', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Texas Health Science Center at Houston and TIRR, Memorial Hermann Hospital, Houston, TX, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Gutierrez-Verduzco', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Texas Health Science Center at Houston and TIRR, Memorial Hermann Hospital, Houston, TX, USA.'}, {'ForeName': 'Gerard E', 'Initials': 'GE', 'LastName': 'Francisco', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Texas Health Science Center at Houston and TIRR, Memorial Hermann Hospital, Houston, TX, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhou', 'Affiliation': 'Institute of Rehabilitation Engineering, The University of Rehabilitation, Qingdao, P. R. China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Texas Health Science Center at Houston and TIRR, Memorial Hermann Hospital, Houston, TX, USA.'}, {'ForeName': 'Yingchun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Biomedical Engineering, University of Houston, Houston, TX, USA.'}]",International journal of neural systems,['10.1142/S0129065721500076'] 1942,33439131,Effects of Website Interactivity on Skin Cancer-Related Intentions and User Experience: Factorial Randomized Experiment.,"BACKGROUND Digital media technologies provide users with the ability to interact with content and to receive information based on their preferences and engagement. OBJECTIVE We used skin cancer and sun protection as a health topic to explore how modality interactivity, interface tools that afford users greater activity, resulting in greater depth and breadth of mentally representing and experiencing mediated content, and message interactivity, the extent to which the system allows users to exchange messages back and forth on health websites, influenced users' attitudes, knowledge, behavioral intentions, and experience. METHODS We employed a 2×2 (modality interactivity: high vs low; message interactivity: high vs low) between-subject online experiment for which 4 websites were created. Participants (n=293) were recruited using Amazon Mechanical Turk and randomly assigned into to 1 of 4 conditions. After browsing the website, participants completed an online survey regarding their experience and cognitive perceptions. General linear models and path analysis were used to analyze the data. RESULTS Both modality interactivity (P=.001) and message interactivity (P<.001) had an impact on intention to use sun protection. Attitudes toward health websites and perceived knowledge mediated the effects of modality interactivity and message interactivity on sun protection use intention, individually. Participants in the high modality interactivity and high message interactivity condition felt more satisfied (P=.02). Participants in the low message interactivity condition had more interest in the experience with health websites than participants in the high message interactivity condition (P=.044). CONCLUSIONS Findings suggested that modality interactivity influenced intention to use sun protection directly as well as via attitudes toward the websites. Message interactivity impacted intention to use sunscreen directly and also through perceived knowledge. Implications for designing health websites and health intervention content are discussed.",2021,"Participants in the low message interactivity condition had more interest in the experience with health websites than participants in the high message interactivity condition (P=.044). ","['Skin Cancer-Related Intentions and User Experience', 'Participants (n=293) were recruited using Amazon Mechanical Turk and randomly assigned into to 1 of 4 conditions']",['Website Interactivity'],[],"[{'cui': 'C0007114', 'cui_str': 'Malignant neoplasm of skin'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0337911', 'cui_str': 'Turks'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",[],[],293.0,0.0592157,"Participants in the low message interactivity condition had more interest in the experience with health websites than participants in the high message interactivity condition (P=.044). ","[{'ForeName': 'Zhaomeng', 'Initials': 'Z', 'LastName': 'Niu', 'Affiliation': 'Section of Behavioral Sciences, Division of Medical Oncology, Rutgers Institute of New Jersey, New Brunswick, NJ, United States.'}, {'ForeName': 'Jessica Fitts', 'Initials': 'JF', 'LastName': 'Willoughby', 'Affiliation': 'The Edward R Murrow College of Communication, Washington State University, Pullman, WA, United States.'}, {'ForeName': 'Elliot J', 'Initials': 'EJ', 'LastName': 'Coups', 'Affiliation': 'Medical Data Analytics, Parsippany, NJ, United States.'}, {'ForeName': 'Jerod L', 'Initials': 'JL', 'LastName': 'Stapleton', 'Affiliation': 'Department of Health, Behavior & Society, College of Public Health, University of Kentucky, Lexington, KY, United States.'}]",Journal of medical Internet research,['10.2196/18299'] 1943,33822433,Hierarchical syntactic processing is beyond mere associating: Functional magnetic resonance imaging evidence from a novel artificial grammar.,"Grammar is central to any natural language. In the past decades, the artificial grammar of the A n B n type in which a pair of associated elements can be nested in the other pair was considered as a desirable model to mimic human language syntax without semantic interference. However, such a grammar relies on mere associating mechanisms, thus insufficient to reflect the hierarchical nature of human syntax. Here, we test how the brain imposes syntactic hierarchies according to the category relations on linearized sequences by designing a novel artificial ""Hierarchical syntactic structure-building Grammar"" (HG), and compare this to the A n B n grammar as a ""Nested associating Grammar"" (NG) based on multilevel associations. Thirty-six healthy German native speakers were randomly assigned to one of the two grammars. Both groups performed a grammaticality judgment task on auditorily presented word sequences generated by the corresponding grammar in the scanner after a successful explicit behavioral learning session. Compared to the NG group, we found that the HG group showed a (a) significantly higher involvement of Brodmann area (BA) 44 in Broca's area and the posterior superior temporal gyrus (pSTG); and (b) qualitatively distinct connectivity between the two regions. Thus, the present study demonstrates that the build-up process of syntactic hierarchies on the basis of category relations critically relies on a distinctive left-hemispheric syntactic network involving BA 44 and pSTG. This indicates that our novel artificial grammar can constitute a suitable experimental tool to investigate syntax-specific processes in the human brain.",2021,"Compared to the NG group, we found that the HG group showed a (a) significantly higher involvement of Brodmann area (BA) 44 in Broca's area and the posterior superior temporal gyrus (pSTG); and (b) qualitatively distinct connectivity between the two regions.",['Thirty-six healthy German native speakers'],['grammaticality judgment task on auditorily presented word sequences generated by the corresponding grammar in the scanner after a successful explicit behavioral learning session'],"[""Brodmann area (BA) 44 in Broca's area and the posterior superior temporal gyrus (pSTG); and (b) qualitatively distinct connectivity""]","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}]","[{'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0599720', 'cui_str': 'Brodmann area'}, {'cui': 'C0006208', 'cui_str': ""Structure of Broca's area""}, {'cui': 'C3850033', 'cui_str': 'Posterior Superior Temporal Gyrus'}]",36.0,0.0703109,"Compared to the NG group, we found that the HG group showed a (a) significantly higher involvement of Brodmann area (BA) 44 in Broca's area and the posterior superior temporal gyrus (pSTG); and (b) qualitatively distinct connectivity between the two regions.","[{'ForeName': 'Luyao', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'College of Chinese Language and Culture, Beijing Normal University, Beijing.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Goucha', 'Affiliation': 'Department of Neuropsychology, Max Planck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Männel', 'Affiliation': 'Department of Neuropsychology, Max Planck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany.'}, {'ForeName': 'Angela D', 'Initials': 'AD', 'LastName': 'Friederici', 'Affiliation': 'Department of Neuropsychology, Max Planck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany.'}, {'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Zaccarella', 'Affiliation': 'Department of Neuropsychology, Max Planck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany.'}]",Human brain mapping,['10.1002/hbm.25432'] 1944,33429741,Comparison of the efficacy of rivaroxaban and dabigatran etexilate in preventing venous thrombosis after arthroplasty: A protocol of randomized controlled trial.,,2021,,['venous thrombosis after arthroplasty'],['rivaroxaban and dabigatran etexilate'],[],"[{'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C1571583', 'cui_str': 'dabigatran etexilate'}]",[],,0.145168,,"[{'ForeName': 'Runze', 'Initials': 'R', 'LastName': 'Song', 'Affiliation': 'Department of Vascular Surgery, Lanzhou University Second Hospital, Lanzhou 730030, Gansu Province, China.'}, {'ForeName': 'Ruisheng', 'Initials': 'R', 'LastName': 'Qu', 'Affiliation': ''}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Anping', 'Initials': 'A', 'LastName': 'Zhang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000023814'] 1945,33449120,Can digital communication technology reduce health system personnel time? An evaluation of personnel requirements and costs in a randomized controlled trial.,"Use of digital communication technologies (DCT) shows promise for enhancing outcomes and efficiencies in asthma care management. However, little is known about the impact of DCT interventions on healthcare personnel requirements and costs, thus making it difficult for providers and health systems to understand the value of these interventions. This study evaluated the differences in healthcare personnel requirements and costs between usual asthma care (UC) and a DCT intervention (Breathewell) aimed at maintaining guidelines-based asthma care while reducing health care staffing requirements. We used data from a pragmatic, randomized controlled trial conducted in a large integrated health system involving 14,978 patients diagnosed with asthma. To evaluate differences in staffing requirements and cost between Breathewell and UC needed to deliver guideline-based care we used electronic health record (EHR) events, provider time tracking surveys, and invoicing. Differences in cost were reported at the patient and health system level. The Breathewell intervention significantly reduced personnel requirements with a larger percentage of participants requiring no personnel time (45% vs. 5%, p < .001) and smaller percentage of participants requiring follow-up outreach (44% vs. 68%, p < .001). Extrapolated to the total health system, cost for the Breathewell intervention was $16,278 less than usual care. The intervention became cost savings at a sample size of at least 957 patients diagnosed with asthma. At the population level, using DCT to compliment current asthma care practice presents an opportunity to reduce healthcare personnel requirements while maintaining population-based asthma control measures.",2021,"Extrapolated to the total health system, cost for the Breathewell intervention was $16,278 less than usual care.","['957 patients diagnosed with asthma', '14,978 patients diagnosed with asthma']","['usual asthma care (UC) and a DCT intervention (Breathewell) aimed at maintaining guidelines-based asthma care', 'digital communication technologies (DCT', 'DCT interventions']","['cost savings', 'personnel requirements']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C1318955', 'cui_str': 'Asthma management'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0683867', 'cui_str': 'Information Technology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0085550', 'cui_str': 'Cost Savings'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}]",14978.0,0.0490793,"Extrapolated to the total health system, cost for the Breathewell intervention was $16,278 less than usual care.","[{'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Wagner', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, CO, USA.'}, {'ForeName': 'Debra P', 'Initials': 'DP', 'LastName': 'Ritzwoller', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, CO, USA.'}, {'ForeName': 'Marsha A', 'Initials': 'MA', 'LastName': 'Raebel', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, CO, USA.'}, {'ForeName': 'Glenn K', 'Initials': 'GK', 'LastName': 'Goodrich', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, CO, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Cvietusa', 'Affiliation': 'Department of Asthma, Allergy and Immunology, Kaiser Permanente Colorado, Denver, CO, USA.'}, {'ForeName': 'Diane K', 'Initials': 'DK', 'LastName': 'King', 'Affiliation': 'Center for Behavioral Health Research and Services, Institute of Social and Economic Research, University of Alaska Anchorage, Anchorage, AK, USA.'}, {'ForeName': 'Jo Ann', 'Initials': 'JA', 'LastName': 'Shoup', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, CO, USA.'}, {'ForeName': 'Bruce G', 'Initials': 'BG', 'LastName': 'Bender', 'Affiliation': 'Division of Pediatric Behavioral Health, National Jewish Health, Denver, CO, USA.'}]",Translational behavioral medicine,['10.1093/tbm/ibaa130'] 1946,33453045,Adapting the InPACT Intervention to Enhance Implementation Fidelity and Flexibility.,"Adapting classroom-based physical activity interventions are critical for program feasibility and fidelity in low-resource elementary schools. The purpose of this pilot study was to use Replicating Effective Programs (REP) framework to tailor the Interrupting Prolonged sitting with ACTivity (InPACT) intervention and evaluate its effectiveness on program fidelity in classrooms within a low-resource school. REP was applied to adapt program packaging, teacher training, and technical assistance to disseminate Tailored InPACT, a 20-week intervention where teachers implemented 5 × 4-min activity breaks per day. Tailored InPACT was implemented in nine, 3rd-6th grade classrooms in one low-resource school in Detroit Michigan (80% qualified for free/reduced lunch). Intervention fidelity was measured via daily, weekly, and end-of-study self-report questionnaires and direct observation. Throughout the 20-week intervention period, 3rd-5th grade teachers achieved intervention dose (5 activity breaks per day at an average duration of 4 min 8 s). Sixth grade teachers did not achieve intervention dose as they were only able to implement 2 activity breaks per day at an average duration of 4 min 12 s. These findings suggest 5 × 4-min classroom activity breaks per day is a feasible dose of classroom activity that 3rd-5th grade teachers can implement in low-resource classroom settings. Additional adaptations are needed to maximize fidelity in 6th grade classrooms.",2021,The purpose of this pilot study was to use Replicating Effective Programs (REP) framework to tailor the Interrupting Prolonged sitting with ACTivity (InPACT) intervention and evaluate its effectiveness on program fidelity in classrooms within a low-resource school.,"['classrooms within a low-resource school', 'low-resource elementary schools']","['Adapting classroom-based physical activity interventions', 'InPACT Intervention', 'Prolonged sitting with ACTivity (InPACT) intervention', 'REP']",['Intervention fidelity'],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0443239', 'cui_str': 'Interrupted'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.0128631,The purpose of this pilot study was to use Replicating Effective Programs (REP) framework to tailor the Interrupting Prolonged sitting with ACTivity (InPACT) intervention and evaluate its effectiveness on program fidelity in classrooms within a low-resource school.,"[{'ForeName': 'Rebecca E', 'Initials': 'RE', 'LastName': 'Hasson', 'Affiliation': 'School of Kinesiology, University of Michigan, Ann Arbor, MI, USA. hassonr@umich.edu.'}, {'ForeName': 'Lexie R', 'Initials': 'LR', 'LastName': 'Beemer', 'Affiliation': 'School of Kinesiology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Tiwaloluwa A', 'Initials': 'TA', 'LastName': 'Ajibewa', 'Affiliation': 'School of Kinesiology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Andria B', 'Initials': 'AB', 'LastName': 'Eisman', 'Affiliation': 'College of Education, Wayne State University, Detroit, MI, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01199-z'] 1947,33465382,"The effects of abdominal ""I LOV U"" massage along with lifestyle training on constipation and distension in the elderly with stroke.","INTRODUCTION Constipation and distension are dominant gastrointestinal problems after stroke in the elderly. Always they are treated by the use of laxatives and fibers. Abdominal massage along with a healthy lifestyle can be a solution. PURPOSE This study aimed to investigate the effect of abdominal massage and lifestyle training on constipation and distention of the elderly with stroke. METHOD This study was a randomized clinical trial that was conducted on elderly patients with stroke at Qaem hospital of Mashhad, Iran. 68 patients were randomly allocated into control (n = 34) and intervention (n = 34) groups in 2017-2018. Finally 29 elderly in the intervention and 34 in the control group completed the study. Intervention included the abdominal massage by using ""I LOV U"" method along with lifestyle education. Each abdominal massage lasted for 15 min, twice daily for ten days that was performed at first session by the researcher and then continued by the key care giver. Data were collected by the demographic form, constipation assessment score (CAS), distension measurement tool (meter), and food tolerance evaluation checklist. RESULTS The results indicated that both groups were homogeneous in demographic variables (P > 0.05). The repeated ANOVA showed a more significant decrease in abdominal circumference of the intervention group during the 10- days study (P = 0.029).The Friedman test showed a significant difference in frequency of defecation in two groups in 10- day study (P < 0.0001). Therefore the CAS Score was significantly decreased in intervention group more than the control group (0.30 < 0.98 < 1.59, P = 0.001, EF = 0.44). The food tolerance frequencies through Gavage (P = 0.20), and also orally (P < 0.001) were significantly improved in the intervention group. CONCLUSION According to results, the abdominal massage along with lifestyle training could improve constipation and distension and also increase food intake tolerance in the elderly patients with stroke.",2021,"Therefore the CAS Score was significantly decreased in intervention group more than the control group (0.30 < 0.98 < 1.59, P = 0.001, EF = 0.44).","['Finally 29 elderly in the intervention and 34 in the control group completed the study', 'Elderly with Stroke', 'constipation and distention of the elderly with stroke', '68 patients', 'elderly patients with stroke', 'elderly patients with stroke at Qaem hospital of Mashhad, Iran']","['Lifestyle Training', 'lifestyle training', 'abdominal massage by using ""I LOV U"" method along with lifestyle education', 'Abdominal massage', 'abdominal massage and lifestyle training', 'Abdominal ""I LOV U"" Massage']","['constipation and distension', 'frequency of defecation', 'food intake tolerance', 'abdominal circumference', 'Constipation and Distension', 'CAS Score', 'demographic form, constipation assessment score (CAS), distension measurement tool (meter), and food tolerance evaluation checklist']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C2316341', 'cui_str': 'Massage of abdomen'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0581872', 'cui_str': 'Frequency of defecation'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]",68.0,0.0244849,"Therefore the CAS Score was significantly decreased in intervention group more than the control group (0.30 < 0.98 < 1.59, P = 0.001, EF = 0.44).","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Fekri', 'Affiliation': 'Department of Medical Surgical nursing, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Aghebati', 'Affiliation': 'Department of Medical Surgical nursing, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran; Nursing and Midwifery Care Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: aghebatin@mums.ac.ir.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Sadeghi', 'Affiliation': 'Nursing and Midwifery Care Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammd Taghi', 'Initials': 'MT', 'LastName': 'Farzadfard', 'Affiliation': 'Medical School, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2021.102665'] 1948,33465369,"Comparison of intravascular ultrasound-guided with angiography-guided double kissing crush stenting for patients with complex coronary bifurcation lesions: Rationale and design of a prospective, randomized, and multicenter DKCRUSH VIII trial.","BACKGROUND Double kissing (DK) crush approach for patients with coronary bifurcation lesions, particularly localized at distal left main or lesions with increased complexity, is associated with significant reduction in clinical events when compared with provisional stenting. Recently, randomized clinical trial has demonstrated the net clinical benefits by intravascular ultrasound (IVUS)-guided implantation of drug-eluting stent in all-comers. However, the improvement in clinical outcome after DK crush treatment guided by IVUS over angiography guidance for patients with complex bifurcation lesions have never been studied in a randomized fashion. TRIAL DESIGN DKCRUSH VIII study is a prospective, multicenter, randomized controlled trial designed to assess superiority of IVUS-guided vs angiography-guided DK crush stenting in patients with complex bifurcation lesions according to DEFINITION criteria. A total of 556 patients with complex bifurcation lesions will be randomly (1:1 of ratio) assigned to IVUS-guided or angiography-guided DK crush stenting group. The primary end point is the rate of 12-month target vessel failure, including cardiac death, target vessel myocardial infarction, or clinically driven target vessel revascularization. The secondary end points consist of the individual component of primary end point, all-cause death, myocardial infarction, and in-stent restenosis. The safety end point is the incidence of definite or probable stent thrombosis. An angiographic follow-up will be performed for all patients at 13 months and clinical follow-up will be continued annually until 3 years after the index procedure. CONCLUSIONS DKCRUSH VIII trial is the first study designed to evaluate the differences in efficacy and safety between IVUS-guided and angiography-guided DK crush stenting in patients with complex true bifurcation lesions. This study will also provide IVUS-derived criteria to define optimal DK crush stenting for bifurcation lesions at higher complexity.",2021,"The primary endpoint is the rate of 12-month target vessel failure (TVF), including cardiac death, target vessel myocardial infarction (TV-MI) or clinically driven target vessel revascularization (CD-TVR).","['556 patients with complex bifurcation lesions', 'patients with complex bifurcation lesions', 'patients with complex coronary bifurcation lesions', 'patients with complex true bifurcation lesions', 'patients with coronary bifurcation lesions']","['intravascular ultrasound (IVUS)-guided implantation of drug-eluting stent (DES', 'IVUS-guided or angiography-guided DK crush stenting group', 'IVUS-guided versus angiography-guided DK crush stenting', 'Double kissing (DK) crush approach', 'intravascular ultrasound-guided with angiography-guided double kissing crush stenting', 'DK crush treatment guided by IVUS', 'IVUS-guided and angiography-guided DK crush stenting']","['efficacy and safety', 'incidence of definite or probable stent thrombosis', 'individual component of primary endpoint, all-cause death, MI, and in-stent restenosis', 'rate of 12-month target vessel failure (TVF), including cardiac death, target vessel myocardial infarction (TV-MI) or clinically driven target vessel revascularization (CD-TVR']","[{'cui': 'C4517811', 'cui_str': '556'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205238', 'cui_str': 'True'}]","[{'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0185060', 'cui_str': 'Crushing'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3272317', 'cui_str': 'Stent restenosis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",556.0,0.109925,"The primary endpoint is the rate of 12-month target vessel failure (TVF), including cardiac death, target vessel myocardial infarction (TV-MI) or clinically driven target vessel revascularization (CD-TVR).","[{'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Ge', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Kan', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiao-Fei', 'Initials': 'XF', 'LastName': 'Gao', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiang-Quan', 'Initials': 'XQ', 'LastName': 'Kong', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Guang-Feng', 'Initials': 'GF', 'LastName': 'Zuo', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ye', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Nai-Liang', 'Initials': 'NL', 'LastName': 'Tian', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Zhi-Zhong', 'Initials': 'ZZ', 'LastName': 'Liu', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Zhi-Qi', 'Initials': 'ZQ', 'LastName': 'Sun', 'Affiliation': 'Division of Cardiology, Daqing Oilfield General Hospital, Daqing, China.'}, {'ForeName': 'Peng-Cheng', 'Initials': 'PC', 'LastName': 'He', 'Affiliation': ""Division of Cardiology, Guangdong Provincial People's Hospital, Guangzhou, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': 'Division of Cardiology, Harbin First Hospital, Harbin, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Division of Cardiology, The 4th Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Yu-Quan', 'Initials': 'YQ', 'LastName': 'He', 'Affiliation': 'Division of Cardiology, China-Japan Friendship Hospital, Changchun, China.'}, {'ForeName': 'Yu-Zeng', 'Initials': 'YZ', 'LastName': 'Xue', 'Affiliation': ""Division of Cardiology, Liaocheng People's Hospital, Liaocheng, China.""}, {'ForeName': 'Lian-Min', 'Initials': 'LM', 'LastName': 'Wang', 'Affiliation': 'Division of Cardiology, Mudanjiang Cardiovascular Hospital, Mudanjiang, China.'}, {'ForeName': 'Li-Fu', 'Initials': 'LF', 'LastName': 'Miao', 'Affiliation': 'Division of Cardiology, Beijing Huaxin Hospital, the First Hospital of Tsinghua University, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Pu', 'Affiliation': 'Division of Cardiology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Ya-Wu', 'Initials': 'YW', 'LastName': 'Sun', 'Affiliation': ""Division of Cardiology, Shanghai Fourth People's Hospital, Shanghai, China.""}, {'ForeName': 'Shao-Ping', 'Initials': 'SP', 'LastName': 'Nie', 'Affiliation': 'Division of Cardiology, Beijing Anzhen Hospital, Capital Medical Hospital, Beijing, China.'}, {'ForeName': 'Jian-Hong', 'Initials': 'JH', 'LastName': 'Tao', 'Affiliation': ""Division of Cardiology, Sichuan Province People's Hospital, Chengdu, China.""}, {'ForeName': 'Shang-Yu', 'Initials': 'SY', 'LastName': 'Wen', 'Affiliation': ""Division of Cardiology, Tianjin 4th People's Hospital, Tianjin, China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Division of Cardiology, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Su', 'Affiliation': 'Division of Cardiology, Wuhan Asia heart Hospital, Wuhan, China.'}, {'ForeName': 'Qi-Cheng', 'Initials': 'QC', 'LastName': 'Yao', 'Affiliation': 'Division of Cardiology, Shenzhen Hospital, The University of Hong Kong, Shenzhen, China.'}, {'ForeName': 'Yi-Jie', 'Initials': 'YJ', 'LastName': 'Huang', 'Affiliation': 'Division of Cardiology, XuZhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': 'Division of Cardiology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Fa-Rong', 'Initials': 'FR', 'LastName': 'Shen', 'Affiliation': 'Division of Cardiology, Zhejiang Greentown Cardiovascular Hospital, Zhejiang, China.'}, {'ForeName': 'Chun-Guang', 'Initials': 'CG', 'LastName': 'Qiu', 'Affiliation': 'Division of Cardiology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'You-Lin', 'Initials': 'YL', 'LastName': 'Mao', 'Affiliation': ""Division of Cardiology, The 7th People's Hospital of Zhengzhou, Zhengzhou, China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Division of Cardiology, Fuwai Hospital Chinese Academy of Medical Science, Shenzhen, China.'}, {'ForeName': 'Xin-Qun', 'Initials': 'XQ', 'LastName': 'Hu', 'Affiliation': 'Division of Cardiology, The Second Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Zhi-Min', 'Initials': 'ZM', 'LastName': 'Du', 'Affiliation': 'Division of Cardiology, The First Affiliated Hospital of Zhongshan University, Guangzhou, China.'}, {'ForeName': 'Ru-Qiong', 'Initials': 'RQ', 'LastName': 'Nie', 'Affiliation': 'Division of Cardiology, Sun Yat-Sen Memorial Hospital, Zhongshan University, Guangzhou, China.'}, {'ForeName': 'Ya-Ling', 'Initials': 'YL', 'LastName': 'Han', 'Affiliation': 'Division of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Jun-Jie', 'Initials': 'JJ', 'LastName': 'Zhang', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Shao-Liang', 'Initials': 'SL', 'LastName': 'Chen', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China. Electronic address: chmengx@126.com.'}]",American heart journal,['10.1016/j.ahj.2021.01.011'] 1949,33470727,Brief Report: Financial Incentives and Real-Time Adherence Monitoring to Promote Daily Adherence to HIV Treatment and Viral Suppression Among People Living With HIV: A Pilot Study.,"BACKGROUND Interventions to promote medication adherence and viral suppression are needed among HIV-positive individuals. We aimed to determine the feasibility, acceptability, and preliminary impact of daily financial incentives linked to real-time adherence monitoring among treatment-experienced individuals. METHODS At an HIV clinic in Philadelphia, we conducted a pilot randomized trial among treatment-experienced HIV-positive adults with unsuppressed viral loads (>400 copies/mL). Participants randomized to the intervention group were eligible for daily lottery-based financial rewards dependent on antiretroviral therapy (ART) adherence, measured by a wireless-enabled electronic pill bottle. Participants also received a financial incentive for achieving viral suppression at 3 months. The control group received the standard of care. We measured acceptance and feasibility through follow-up survey at 3 months, viral suppression at 3 months, and adherence. RESULTS Among 29 participants, 28 (93%) completed 3-month follow-up, and 24 (83%) completed a 3-month laboratory visit. Electronic pill bottles were highly acceptable to participants, with most strongly agreeing that they worked well, were reliable, and easy to use. Among those who received the intervention, 77% were very satisfied with their experience. Among those who completed the 3-month laboratory visit, viral suppression was achieved by 40% in the intervention group and 29% in the control group. ART adherence ≥80% was achieved by 36% and 25% in the intervention and control groups, respectively. CONCLUSIONS Daily financial incentives coupled with real-time adherence monitoring are a promising strategy to support ART adherence among HIV-positive individuals who are not virally suppressed. This novel approach warrants testing in a larger trial.",2021,"Among those who completed the 3-month lab visit, viral suppression was achieved by 40% in the intervention group and 29% in the control group.","['At an HIV clinic in Philadelphia', 'people living with HIV', '29 participants, 28 (93%) completed 3-month follow-up and 24 (83%) completed a 3-month laboratory visit', 'treatment-experienced HIV-positive adults with unsuppressed viral loads (>400 copies/ml', 'treatment-experienced individuals', 'HIV-positive individuals']","['financial incentive', 'Electronic pill bottles', 'daily lottery-based financial rewards dependent on antiretroviral therapy (ART) adherence, measured by a wireless-enabled electronic pill bottle']","['ART adherence', 'viral suppression']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C3816746', 'cui_str': '400'}]","[{'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0179376', 'cui_str': 'Bottle'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",,0.158211,"Among those who completed the 3-month lab visit, viral suppression was achieved by 40% in the intervention group and 29% in the control group.","[{'ForeName': 'Cedric H', 'Initials': 'CH', 'LastName': 'Bien-Gund', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Joshua I', 'Initials': 'JI', 'LastName': 'Ho', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Elizabeth F', 'Initials': 'EF', 'LastName': 'Bair', 'Affiliation': 'Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; and.'}, {'ForeName': 'Noora', 'Initials': 'N', 'LastName': 'Marcus', 'Affiliation': 'Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; and.'}, {'ForeName': 'Rebekah Ji', 'Initials': 'RJ', 'LastName': 'Choi', 'Affiliation': 'Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; and.'}, {'ForeName': 'Zsofia', 'Initials': 'Z', 'LastName': 'Szep', 'Affiliation': 'Partnership Comprehensive Care Practice, Drexel University College of Medicine, Philadelphia, PA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Althoff', 'Affiliation': 'Partnership Comprehensive Care Practice, Drexel University College of Medicine, Philadelphia, PA.'}, {'ForeName': 'Florence M', 'Initials': 'FM', 'LastName': 'Momplaisir', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Harsha', 'Initials': 'H', 'LastName': 'Thirumurthy', 'Affiliation': 'Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; and.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002628'] 1950,33472052,A randomized ablation-based atrial fibrillation rhythm control versus rate control trial in patients with heart failure and high burden atrial fibrillation: The RAFT-AF trial rationale and design.,"Heart failure (HF) and atrial fibrillation (AF) are 2 cardiac conditions that are increasing in prevalence and incidence. The 2 conditions frequently coexist, and are associated with increased morbidity and mortality. Catheter ablation of AF has been successfully performed in patients with HF, with an improvement in HF and AF, when compared to amiodarone, but further data is required to compare this to rate control. OBJECTIVES: The primary objective is to determine whether AF treated by catheter ablation, with or without antiarrhythmic drugs reduces all-cause mortality and hospitalizations for HF as compared with rate control in patients with HF and a high burden AF. METHODS: This is a multi-center prospective randomized open blinded endpoint (PROBE) study. Patients with NYHA class II-III HF (HF with reduced ejection fraction (<35%) or HF with preserved ejection fraction), and high burden AF are included in the trial. Patients are randomized to either rate control or catheter ablation-based AF rhythm control in a 1:1 ratio. Patients in the rate control group receive optimal HF therapy and rate control measures to achieve a resting hazard ratio (HR) < 80 bpm and 6-minute walk HR < 110 bpm. Patients randomized to catheter ablation-based AF rhythm control group receive optimal HF therapy and one or more aggressive catheter ablation, which include PV antral ablation and LA substrate ablation with or without adjunctive antiarrhythmic drug. The primary outcome is a composite of all-cause mortality and hospitalization for heart failure defined as an admission to a health care facility. The sample size is 600. Enrolment has been completed.",2021,"Catheter ablation of AF has been successfully performed in patients with HF, with an improvement in HF and AF, when compared to amiodarone, but further data is required to compare this to rate control.","['patients with heart failure and high burden Atrial Fibrillation', 'patients with HF', 'Patients with NYHA class II-III HF (HF with reduced ejection fraction (<35%) or HF with preserved ejection fraction), and high burden AF are included in the trial', 'patients with HF and a high burden AF']","['AF treated by catheter ablation', 'rate control or catheter ablation-based AF rhythm control', 'optimal HF therapy', 'catheter ablation-based AF rhythm control group receive optimal HF therapy and one or more aggressive catheter ablation, which include PV antral ablation and LA substrate ablation with or without adjunctive antiarrhythmic drug', 'Ablation-based atrial Fibrillation rhythm control', 'amiodarone']","['composite of all-cause mortality and hospitalization for heart failure defined as an admission to a health care facility', 'Heart failure (HF) and atrial fibrillation (AF', 'morbidity and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0293352', 'cui_str': 'Antral'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}, {'cui': 'C0002598', 'cui_str': 'Amiodarone'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",,0.0266138,"Catheter ablation of AF has been successfully performed in patients with HF, with an improvement in HF and AF, when compared to amiodarone, but further data is required to compare this to rate control.","[{'ForeName': 'Ratika', 'Initials': 'R', 'LastName': 'Parkash', 'Affiliation': 'Queen Elizabeth II Health Sciences Center, Halifax, Nova Scotia, Canada. Electronic address: Ratika.parkash@nshealth.ca.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Wells', 'Affiliation': 'University of Ottawa Cardiovascular Research Methods Center, Ottawa, ON, Canada.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Rouleau', 'Affiliation': 'Montreal Heart Institute, Montreal, QC, Canada.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Talajic', 'Affiliation': 'Montreal Heart Institute, Montreal, QC, Canada.'}, {'ForeName': 'Vidal', 'Initials': 'V', 'LastName': 'Essebag', 'Affiliation': 'McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Skanes', 'Affiliation': 'Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.'}, {'ForeName': 'Steve B', 'Initials': 'SB', 'LastName': 'Wilton', 'Affiliation': 'Libin Cardiovascular Institute, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Verma', 'Affiliation': 'Southlake Medical Centre, ON, Canada.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Healey', 'Affiliation': 'Population Health Research Institute, Hamilton, ON, Canada.'}, {'ForeName': 'Anthony Sl', 'Initials': 'AS', 'LastName': 'Tang', 'Affiliation': 'Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.'}]",American heart journal,['10.1016/j.ahj.2021.01.012'] 1951,33471963,A study protocol for a feasibility trial of telephone-delivered Adherence Therapy for adults with type 2 diabetes.,"AIMS Adherence therapy is a candidate intervention to improve medication adherence and clinical outcomes in patients with type 2 diabetes. The feasibility of conducting a trial of adherence therapy in this population has not been established. The objective of this study is therefore to test the feasibility of conducting a randomized controlled trial of adherence therapy in a Middle Eastern context. DESIGN A single-centre randomized controlled feasibility trial of adherence therapy in patients with type 2 diabetes. METHODS We will undertake an initial cultural adaptation of a telephone-delivered form of adherence therapy in four patients in a Middle Eastern context. Our subsequent feasibility trial will aim to recruit 40 non-adherent diabetic patients that will be randomly allocated to receive eight weekly 30-min telephone adherence therapy sessions delivered by a diabetes educator versus treatment as usual. Key outcomes of interest include the number of patients invited to take part in the trial that consent to participate and then go on to complete treatment. RESULT The findings of this study will determine the feasibility of undertaking a full randomized controlled trial of adherence therapy in patients with type 2 diabetes.",2021,We will undertake an initial cultural adaptation of a telephone-delivered form of adherence therapy in four patients in a Middle Eastern context.,"['a Middle Eastern context', 'adults with type 2 diabetes', '40 non-adherent diabetic patients', 'four patients in a Middle Eastern context', 'patients with type 2 diabetes']","['adherence therapy', 'telephone-delivered Adherence Therapy', 'telephone adherence therapy sessions', 'telephone-delivered form of adherence therapy']",['medication adherence and clinical outcomes'],"[{'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",40.0,0.111472,We will undertake an initial cultural adaptation of a telephone-delivered form of adherence therapy in four patients in a Middle Eastern context.,"[{'ForeName': 'Fatimah', 'Initials': 'F', 'LastName': 'Alenazi', 'Affiliation': 'College of Science Health and Engineering, La Trobe University, Bundoora, VIC, Australia.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Peddle', 'Affiliation': 'Lecturer in Nursing, School of Nursing and Midwifery, College of Science Health and Engineering, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bressington', 'Affiliation': 'Associate Professor, School of Nursing, Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Moeber', 'Initials': 'M', 'LastName': 'Mahzari', 'Affiliation': 'Assistant professor of Medicine-Endocrinology, King Saud Bin Abdulaziz University for Health Sciences, College of Medicine, Riyadh, KSA, Saudi Arabia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gray', 'Affiliation': 'Professor of Clinical Nursing Practice, La Trobe University, Melbourne, Australia.'}]",Nursing open,['10.1002/nop2.735'] 1952,33474707,Clinical Outcomes and Healthcare Resource Utilization in a Real-World Population Reflecting the DAPA-CKD Trial Participants.,"INTRODUCTION The DAPA-CKD trial assessed dapagliflozin in patients with chronic kidney disease (CKD) with or without type 2 diabetes (T2D). To aid interpretation of results, renal and cardiovascular outcomes plus healthcare resource utilization (HCRU) and costs were assessed in a real-world population similar to that of DAPA-CKD. METHODS Henry Ford Health System (2006-2016) data were used to identify patients with CKD stages 2-4 [estimated glomerular filtration rate (eGFR) 25-75 ml/min/1.73 m 2 at index and urine albumin-to-creatinine ratio (UACR) 0-5000 mg/g; n = 22,251]. Included patients had confirmatory eGFR ≥ 90 days post-index and no kidney transplant or progression to end-stage kidney disease during 12 months pre-index. The final population (n = 6557) was stratified by UACR (0-29, 30-199 and 200-5000 mg/g; the last comprising the DAPA-CKD-like cohort). Patients were followed for 5 years post-index. RESULTS Adverse clinical outcomes incidence increased with UACR and was highest for the DAPA-CKD-like cohort (UACR 200-5000 mg/g) versus lower UACR categories (0-29 mg/g and 30-199 mg/g): renal composite outcome (progression to CKD stage 5, dialysis, transplant, ≥ 50% sustained eGFR decline): 26.0% versus 2.2% and 5.8%; heart failure (HF): 36.1% versus 13.9% and 24.6%; myocardial infarction: 11.3% versus 4.7% and 7.4%; stroke: 8.9% versus 4.0% and 5.7%; and mortality: 18.5% versus 6.0% and 11.7%, respectively. Within the DAPA-CKD-like cohort, patients with versus without T2D or HF had a higher frequency of adverse outcomes. The DAPA-CKD-like cohort also had significantly higher annualized per-patient healthcare costs ($39,222/year versus $19,547/year), hospital admission rate (0.55/year versus 0.20/year) and outpatient specialist visit rate (7.55/year versus 6.74/year) versus the lowest UACR category. CONCLUSION The significant adverse renal and cardiovascular outcomes observed, particularly in the DAPA-CKD-like cohort, represent a substantial burden resulting in increased mortality, HCRU and costs, demonstrating the need for additional treatment options.",2021,"The DAPA-CKD-like cohort also had significantly higher annualized per-patient healthcare costs ($39,222/year versus $19,547/year), hospital admission rate (0.55/year versus 0.20/year) and outpatient specialist visit rate (7.55/year versus 6.74/year) versus the lowest UACR category. ","['patients with chronic kidney disease (CKD) with or without type 2 diabetes (T2D', 'Included patients had confirmatory eGFR\u2009≥', 'Henry Ford Health System (2006-2016) data were used to identify patients with CKD stages 2-4 [estimated glomerular filtration rate (eGFR) 25-75\xa0ml', 'a Real-World Population']",['dapagliflozin'],"['mortality, HCRU and costs', 'mortality', 'annualized per-patient healthcare costs', 'kidney transplant or progression to end-stage kidney disease', 'hospital admission rate', 'lower UACR categories', 'myocardial infarction', 'heart failure', 'outpatient specialist visit rate', 'adverse renal and cardiovascular outcomes', 'renal composite outcome', 'urine albumin-to-creatinine ratio (UACR) 0']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0582517', 'cui_str': 'henry'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1269815', 'cui_str': 'Patient identification'}, {'cui': 'C2316786', 'cui_str': 'Chronic kidney disease stage 2'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0042038', 'cui_str': 'Albumin urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0493742,"The DAPA-CKD-like cohort also had significantly higher annualized per-patient healthcare costs ($39,222/year versus $19,547/year), hospital admission rate (0.55/year versus 0.20/year) and outpatient specialist visit rate (7.55/year versus 6.74/year) versus the lowest UACR category. ","[{'ForeName': 'Tope', 'Initials': 'T', 'LastName': 'Olufade', 'Affiliation': 'AstraZeneca, Wilmington, DE, USA. Tope.Olufade@astrazeneca.com.'}, {'ForeName': 'Lois', 'Initials': 'L', 'LastName': 'Lamerato', 'Affiliation': 'Department of Public Health Sciences, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Juan José García', 'Initials': 'JJG', 'LastName': 'Sánchez', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Like', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'AstraZeneca, Wilmington, DE, USA.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'AstraZeneca, Wilmington, DE, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Nolan', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Janani', 'Initials': 'J', 'LastName': 'Rangaswami', 'Affiliation': 'Einstein Medical Center, Philadelphia, PA, USA.'}]",Advances in therapy,['10.1007/s12325-020-01609-2'] 1953,33474705,Evaluation of Cardiac Repolarization in the Randomized Phase 2 Study of Intermediate- or High-Risk Smoldering Multiple Myeloma Patients Treated with Daratumumab Monotherapy.,"INTRODUCTION Daratumumab is a CD38-targeting monoclonal antibody that has demonstrated clinical benefit for multiple myeloma. Daratumumab inhibition of CD38, which is expressed on immune cell populations and cardiomyocytes, could potentially affect cardiac function. This QTc substudy of the phase 2 CENTAURUS study investigated the potential effect of intravenous daratumumab monotherapy on QTc prolongation and other electrocardiogram (ECG) parameters, including concentration-QTc effect modeling. METHODS Patients had intermediate- or high-risk smoldering multiple myeloma. Patients with QT interval corrected by Fridericia's formula (QTcF) > 470 ms, QRS interval ≥ 110 ms, or PR interval ≥ 200 ms were excluded. Triplicate ECGs were collected at screening, Dose 1, and Dose 8. Analyses of on-treatment ECGs were conducted with a time-matched baseline (primary analysis). By time-point, pharmacokinetic-pharmacodynamic (PK/PD), and outlier analyses were conducted. RESULTS Of 123 patients in CENTAURUS, 31 were enrolled in the QTc substudy. Daratumumab produced a small increase in heart rate (5-12 beats per minute) of unclear significance. There was a small but clinically insignificant effect on QTc, as measured by both time-matched time-point and PK/PD analyses. The primary analysis demonstrated a maximum mean increase in QTcF of 9.1 ms (90% 2-sided upper confidence interval [CI], 14.1 ms). The primary PK/PD analysis predicted a maximum QTcF increase of 8.5 ms (90% 2-sided upper CI, 13.5 ms). No patient had an abnormal U wave, a new QTcF > 500 ms, or > 60 ms change from baseline for QTcF. CONCLUSION Analysis of ECG intervals and concentration-QTc relationships showed a small but clinically insignificant effect of daratumumab. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02316106.",2021,"Daratumumab inhibition of CD38, which is expressed on immune cell populations and cardiomyocytes, could potentially affect cardiac function.","[""Patients with QT interval corrected by Fridericia's formula (QTcF)\u2009>\u2009470\xa0ms, QRS interval\u2009≥"", '123 patients in CENTAURUS', 'Patients had intermediate- or high-risk']","['intravenous daratumumab monotherapy', 'Intermediate- or High-Risk', 'Daratumumab Monotherapy']","['maximum QTcF increase', 'heart rate', 'QTcF', 'ECG intervals and concentration-QTc relationships', 'QTc prolongation and other electrocardiogram (ECG) parameters, including concentration-QTc effect modeling', 'QTc', 'PR interval\u2009≥']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0520880', 'cui_str': 'QRS interval'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0855333', 'cui_str': 'Electrocardiogram QT corrected interval prolonged'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0429087', 'cui_str': 'PR interval - finding'}]",31.0,0.0480989,"Daratumumab inhibition of CD38, which is expressed on immune cell populations and cardiomyocytes, could potentially affect cardiac function.","[{'ForeName': 'Ajai', 'Initials': 'A', 'LastName': 'Chari', 'Affiliation': 'Tisch Cancer Institute, Mount Sinai School of Medicine, New York, NY, USA. ajai.chari@mountsinai.org.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Munder', 'Affiliation': 'Third Department of Medicine, University Medical Center of the Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Weisel', 'Affiliation': 'University Medical Center of Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Jenner', 'Affiliation': 'Southampton General Hospital, Southampton, UK.'}, {'ForeName': 'Ceri', 'Initials': 'C', 'LastName': 'Bygrave', 'Affiliation': 'University Hospital Wales, Cardiff, UK.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Petrucci', 'Affiliation': 'Division of Hematology, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Boccadoro', 'Affiliation': 'University of Torino, Torino, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, ""Seràgnoli"" Institute of Hematology, Bologna University School of Medicine, Bologna, Italy.'}, {'ForeName': 'Niels W C J', 'Initials': 'NWCJ', 'LastName': 'van de Donk', 'Affiliation': 'Department of Hematology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Turgut', 'Affiliation': 'Ondokuz Mayis University Medical Faculty Department of Hematology, Samsun, Turkey.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Demirkan', 'Affiliation': 'Division of Hematology, Dokuz Eylul University, Izmir, Turkey.'}, {'ForeName': 'Ihsan', 'Initials': 'I', 'LastName': 'Karadogan', 'Affiliation': 'Medstar Antalya Hastanesi, Antalya, Turkey.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Libby', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kleiman', 'Affiliation': 'eResearch Technology, Inc., Philadelphia, PA, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Kuppens', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Bandekar', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Neff', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Heuck', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Qi', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Pamela L', 'Initials': 'PL', 'LastName': 'Clemens', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Goldschmidt', 'Affiliation': 'University Clinic Heidelberg, Internal Medicine V and National Center for Tumor Diseases (NCT), Heidelberg, Germany.'}]",Advances in therapy,['10.1007/s12325-020-01601-w'] 1954,33306592,Effects of Transspinal Direct Current Stimulation on Cycling Perception of Effort and Time to Exhaustion.,"ABSTRACT Ciccone, AB, Fry, AC, Emerson, DM, Gallagher, PM, Herda, TJ, and Weir, JP. Effects of transspinal direct current stimulation on cycling perception of effort and time to exhaustion. J Strength Cond Res 35(2): 347-352, 2021-In the past decade, researchers have investigated the efficacy of transspinal direct current stimulation (tsDCS) on the central nervous system and afferent neuron function in humans. Recently, data have suggested it may be possible for such tsDCS-induced changes in neuromuscular function to enhance performance. This study used noninvasive thoracic spine tsDCS to determine if cycling performance and perception of effort could be modulated by tsDCS. In 3 different stimulation conditions, anodal, cathodal, and sham, subjects cycled at 80% of their maximal aerobic capacity until exhaustion and reported their rating of perceived exertion (RPE) every minute. From this period, we compared the RPE responses over the first 3 minutes and time to exhaustion. There was no significant difference in time to exhaustion between anodal (408 ± 121 seconds), cathodal (413 ± 168 seconds), and sham (440 ± 189 seconds) conditions (p = 0.58). There was no significant difference in RPE from minutes 1-3 (collapsed across time) between anodal (12.9 ± 2.4 arbitrary units (AUs)), cathodal (13.3 ± 2.2 AUs), and sham (12.9 ± 2.1 AUs) conditions (p = 0.51). These data suggest tsDCS condition did not influence cycling performance or perception of effort during high-intensity cycling. Therefore, thoracic spine and lower abdominal montage delivering a current density of 0.071 mA·cm-2 for 20 minutes likely does not substantially improve high-intensity cycling work capacity. Therefore, more research is needed to investigate the efficacy of tsDCS and which stimulation methods may and may not enhance human performance.",2021,"There was no significant difference in RPE from minutes 1-3 (collapsed across time) between anodal (12.9 ± 2.4 arbitrary units (AUs)), cathodal (13.3 ± 2.2 AUs), and sham (12.9 ± 2.1 AUs) conditions (p = 0.51).","['347-352, 2021-In the past decade', 'J Strength Cond Res 35(2', 'humans']","['transspinal direct current stimulation (tsDCS', 'Transspinal Direct Current Stimulation', 'transspinal direct current stimulation']","['RPE responses', 'RPE', 'cycling perception of effort and time to exhaustion', 'time to exhaustion', 'Cycling Perception of Effort and Time to Exhaustion']","[{'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}]",,0.0657055,"There was no significant difference in RPE from minutes 1-3 (collapsed across time) between anodal (12.9 ± 2.4 arbitrary units (AUs)), cathodal (13.3 ± 2.2 AUs), and sham (12.9 ± 2.1 AUs) conditions (p = 0.51).","[{'ForeName': 'Anthony B', 'Initials': 'AB', 'LastName': 'Ciccone', 'Affiliation': 'Department of Exercise Science and Outdoor Recreation, Utah Valley University, Orem, Utah; and.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Fry', 'Affiliation': 'Osness Human Performance Laboratories, Department of Health, Sport, and Exercise Sciences, University of Kansas, Lawrence, Kansas.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Emerson', 'Affiliation': 'Osness Human Performance Laboratories, Department of Health, Sport, and Exercise Sciences, University of Kansas, Lawrence, Kansas.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Gallagher', 'Affiliation': 'Osness Human Performance Laboratories, Department of Health, Sport, and Exercise Sciences, University of Kansas, Lawrence, Kansas.'}, {'ForeName': 'Trent J', 'Initials': 'TJ', 'LastName': 'Herda', 'Affiliation': 'Osness Human Performance Laboratories, Department of Health, Sport, and Exercise Sciences, University of Kansas, Lawrence, Kansas.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Weir', 'Affiliation': 'Osness Human Performance Laboratories, Department of Health, Sport, and Exercise Sciences, University of Kansas, Lawrence, Kansas.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003876'] 1955,33496955,Stapler-less burst pressure in an ex vivo human gastric tissue: a randomized controlled trial.,"Stapler-less laparoscopic sleeve gastrectomy (LSG) is emerging as a new potential affordable cost-effective alternative procedure. However, no pre-clinical data are currently available on human tissue. We aimed to evaluate whether traditionally suturing without the use of surgical stapling may produce a comparable bursting pressure on human gastric tissue. A prospective cohort of consecutive patients undergoing LSG was divided in two groups to compare a barbed extra-mucosal running suture (stapler-less) versus a standard stapler line. A burst pressure test was applied to the gastric specimen employing high-resolution manometric catheter. Type, location and features of the leak were described. We enrolled a total of 40 obese patients, 20 patients for each group. Median burst pressures of the stapler-less group resulted statistically significant increased (p < 0.0001) than the one in standard stapler group. In all cases, leak occurred along the surgical closure site independently from the used technique (group 1 vs 2; p = N.S.), more often at the proximal stomach (p < 0.05). In human ex vivo model, traditional surgical suture (i.e. running hand-sewn) produced an effective temporary closure, with superior resistance to increasing volume and pressure. How this may impact on clinical LSG outcomes needs further evaluations and was not the object of this study.",2021,Median burst pressures of the stapler-less group resulted statistically significant increased (p < 0.0001) than the one in standard stapler group.,"['40 obese patients, 20 patients for each group', 'consecutive patients undergoing']","['surgical stapling', 'Stapler-less laparoscopic sleeve gastrectomy (LSG', 'barbed extra-mucosal running suture (stapler-less) versus a standard stapler line', 'Stapler-less burst pressure', 'LSG']","['Median burst pressures', 'leak']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0206263', 'cui_str': 'Surgical stapling'}, {'cui': 'C0441062', 'cui_str': 'Stapler'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}]",40.0,0.0278734,Median burst pressures of the stapler-less group resulted statistically significant increased (p < 0.0001) than the one in standard stapler group.,"[{'ForeName': 'Gianmattia', 'Initials': 'G', 'LastName': 'Del Genio', 'Affiliation': 'Division of General, Mininvasive and Bariatric Surgery, University of Campania ""Luigi Vanvitelli"", Via Pansini 5, 80100, Naples, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Gambardella', 'Affiliation': 'Division of General, Mininvasive and Bariatric Surgery, University of Campania ""Luigi Vanvitelli"", Via Pansini 5, 80100, Naples, Italy. claudiog86@hotmail.it.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Tolone', 'Affiliation': 'Division of General, Mininvasive and Bariatric Surgery, University of Campania ""Luigi Vanvitelli"", Via Pansini 5, 80100, Naples, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Brusciano', 'Affiliation': 'Division of General, Mininvasive and Bariatric Surgery, University of Campania ""Luigi Vanvitelli"", Via Pansini 5, 80100, Naples, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Parmeggiani', 'Affiliation': 'Division of General, Mininvasive and Bariatric Surgery, University of Campania ""Luigi Vanvitelli"", Via Pansini 5, 80100, Naples, Italy.'}, {'ForeName': 'Mariachiara', 'Initials': 'M', 'LastName': 'Lanza Volpe', 'Affiliation': 'Division of General, Mininvasive and Bariatric Surgery, University of Campania ""Luigi Vanvitelli"", Via Pansini 5, 80100, Naples, Italy.'}, {'ForeName': 'Francesco Saverio', 'Initials': 'FS', 'LastName': 'Lucido', 'Affiliation': 'Division of General, Mininvasive and Bariatric Surgery, University of Campania ""Luigi Vanvitelli"", Via Pansini 5, 80100, Naples, Italy.'}, {'ForeName': 'Ludovico', 'Initials': 'L', 'LastName': 'Docimo', 'Affiliation': 'Division of General, Mininvasive and Bariatric Surgery, University of Campania ""Luigi Vanvitelli"", Via Pansini 5, 80100, Naples, Italy.'}]",Updates in surgery,['10.1007/s13304-021-00975-y'] 1956,33453192,Extracorporeal Shock Wave Therapy Combined With Oral Medication and Exercise for Chronic Low Back Pain: A Randomized Controlled Trial.,"OBJECTIVE To compare extracorporeal shock wave therapy combined with oral medication and an exercise program vs sham treatment with medication and exercise for the treatment of chronic low back pain (CLBP). DESIGN Randomized controlled trial. SETTING Outpatient clinic at a university hospital. PARTICIPANTS Eligibility criteria were age older than 18 years and duration of CLBP exceeding 3 months. Exclusion criteria were concurrent treatment or history of surgery for CLBP, cancer, fractures, infections, and disk degeneration. INTERVENTION The intervention group received extracorporeal shock wave therapy once a week for 4 weeks along with oral medications and an exercise program. The control group received sham extracorporeal shock wave therapy along with oral medications and an exercise program. MAIN OUTCOME MEASURES Visual analog scale and Oswestry Disability Index (ODI) were used to assess pain and disability at baseline and after 3 months. RESULTS The pain score in the intervention group (N=16) was 6.6 at baseline and 3.0 after 1 month (P<.0001) and 1.8 after 3 months (P<.0001). In the control group (N=16), the pain score was 6.8 at baseline, 4.6 after 1 month (P<.0001), and 1.1 after 3 months (P<.0001). ODI scores decreased significantly in both groups compared with baseline values (first month: P<.001, third month: P<.05). The mean ODI score did not differ significantly between the groups (P=.942). CONCLUSION Extracorporeal shock wave therapy combined with oral medication and exercise was safe and effective in the short-term treatment of chronic low back pain.",2021,"Disability decreased significantly in both groups compared with baseline values (first month: P<0.0001, third month: P<0.05).","['32 patients with CLBP were referred to Isfahan University Hospitals randomly divided into intervention and control groups', 'patients suffering from CLBP', 'patients with cancer, fractures, infections, disk degeneration, were excluded', 'Patients were enrolled in the study if they were older than 18 years and had CLBP for more than three months']","['Chronic Low Back Pain (Extracorporeal Shock Wave Therapy with oral medication and exercise program versus sham with oral medication and exercise program', 'ESWT', 'sham ESWT along with oral medications and exercise programs', 'CLBP', 'oral medications and exercise programs']","['pain score', 'mean ODI score', 'pain and disability', 'visual analog scale and Oswestry disability index (ODI', 'Disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0158266', 'cui_str': 'Degeneration of intervertebral disc'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C4082119', 'cui_str': 'Three months'}]","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2960603', 'cui_str': 'Oswestry disability index score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}]",32.0,0.0401963,"Disability decreased significantly in both groups compared with baseline values (first month: P<0.0001, third month: P<0.05).","[{'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Taheri', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Khosrawi', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Ramezani', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: mitra.ramezany@gmail.com.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.12.008'] 1957,33461986,"Electronic health record alerts for acute kidney injury: multicenter, randomized clinical trial.","OBJECTIVE To determine whether electronic health record alerts for acute kidney injury would improve patient outcomes of mortality, dialysis, and progression of acute kidney injury. DESIGN Double blinded, multicenter, parallel, randomized controlled trial. SETTING Six hospitals (four teaching and two non-teaching) in the Yale New Haven Health System in Connecticut and Rhode Island, US, ranging from small community hospitals to large tertiary care centers. PARTICIPANTS 6030 adult inpatients with acute kidney injury, as defined by the Kidney Disease: Improving Global Outcomes (KDIGO) creatinine criteria. INTERVENTIONS An electronic health record based ""pop-up"" alert for acute kidney injury with an associated acute kidney injury order set upon provider opening of the patient's medical record. MAIN OUTCOME MEASURES A composite of progression of acute kidney injury, receipt of dialysis, or death within 14 days of randomization. Prespecified secondary outcomes included outcomes at each hospital and frequency of various care practices for acute kidney injury. RESULTS 6030 patients were randomized over 22 months. The primary outcome occurred in 653 (21.3%) of 3059 patients with an alert and in 622 (20.9%) of 2971 patients receiving usual care (relative risk 1.02, 95% confidence interval 0.93 to 1.13, P=0.67). Analysis by each hospital showed worse outcomes in the two non-teaching hospitals (n=765, 13%), where alerts were associated with a higher risk of the primary outcome (relative risk 1.49, 95% confidence interval 1.12 to 1.98, P=0.006). More deaths occurred at these centers (15.6% in the alert group v 8.6% in the usual care group, P=0.003). Certain acute kidney injury care practices were increased in the alert group but did not appear to mediate these outcomes. CONCLUSIONS Alerts did not reduce the risk of our primary outcome among patients in hospital with acute kidney injury. The heterogeneity of effect across clinical centers should lead to a re-evaluation of existing alerting systems for acute kidney injury. TRIAL REGISTRATION ClinicalTrials.gov NCT02753751.",2021,"Analysis by each hospital showed worse outcomes in the two non-teaching hospitals (n=765, 13%), where alerts were associated with a higher risk of the primary outcome (relative risk 1.49, 95% confidence interval 1.12 to 1.98, P=0.006).","['acute kidney injury', 'patients in hospital with acute kidney injury', '6030 patients', 'Six hospitals (four teaching and two non-teaching) in the Yale New Haven Health System in Connecticut and Rhode Island, US, ranging from small community hospitals to large tertiary care centers', '6030 adult inpatients with acute kidney injury, as defined by the Kidney Disease: Improving Global Outcomes (KDIGO) creatinine criteria']",[],"['outcomes at each hospital and frequency of various care practices for acute kidney injury', 'deaths']","[{'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0009778', 'cui_str': 'Connecticut'}, {'cui': 'C0035487', 'cui_str': 'Rhode Island'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]",[],"[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",6030.0,0.649492,"Analysis by each hospital showed worse outcomes in the two non-teaching hospitals (n=765, 13%), where alerts were associated with a higher risk of the primary outcome (relative risk 1.49, 95% confidence interval 1.12 to 1.98, P=0.006).","[{'ForeName': 'F Perry', 'Initials': 'FP', 'LastName': 'Wilson', 'Affiliation': 'Department of Medicine, Section of Nephrology, Yale University School of Medicine, New Haven, CT, USA francis.p.wilson@yale.edu.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Department of Medicine, Section of Nephrology, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Medicine, Section of Nephrology, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Partridge', 'Affiliation': 'Joint Data Analytics Team, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Moreira', 'Affiliation': 'Joint Data Analytics Team, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Tanima', 'Initials': 'T', 'LastName': 'Arora', 'Affiliation': 'Department of Medicine, Section of Nephrology, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Biswas', 'Affiliation': 'Department of Medicine, Section of Nephrology, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Feldman', 'Affiliation': 'Department of Epidemiology and Biostatistics and the Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Amit X', 'Initials': 'AX', 'LastName': 'Garg', 'Affiliation': 'Department of Epidemiology and Biostatistics and Department of Medicine, Division of Nephrology, Schulich School of Medicine & Dentistry, Western University, ON, Canada.'}, {'ForeName': 'Jason H', 'Initials': 'JH', 'LastName': 'Greenberg', 'Affiliation': 'Clinical and Translational Research Accelerator, Department of Medicine, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Hinchcliff', 'Affiliation': 'Department of Medicine, Section of Rheumatology, Allergy and Immunology, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Latham', 'Affiliation': 'Yale Interdisciplinary Center for Bioethics, Yale Law School, New Haven, CT, USA.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Haiqun', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Rutgers University Biomedical and Health Sciences, Newark, NJ, USA.'}, {'ForeName': 'Sherry G', 'Initials': 'SG', 'LastName': 'Mansour', 'Affiliation': 'Department of Medicine, Section of Nephrology, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Dennis G', 'Initials': 'DG', 'LastName': 'Moledina', 'Affiliation': 'Department of Medicine, Section of Nephrology, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Palevsky', 'Affiliation': 'Medicine and Clinical & Translational Science, University of Pittsburgh School of Medicine and Renal Section, VA Pittsburgh Healthcare System, Pittsburgh, PA, USA.'}, {'ForeName': 'Chirag R', 'Initials': 'CR', 'LastName': 'Parikh', 'Affiliation': 'Department of Medicine, Division of Nephrology, John Hopkins Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Simonov', 'Affiliation': 'Clinical and Translational Research Accelerator, Department of Medicine, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Testani', 'Affiliation': 'Department of Internal Medicine, Section of Cardiology, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Ugochukwu', 'Initials': 'U', 'LastName': 'Ugwuowo', 'Affiliation': 'Department of Medicine, Section of Nephrology, Yale University School of Medicine, New Haven, CT, USA.'}]",BMJ (Clinical research ed.),['10.1136/bmj.m4786'] 1958,33471029,Effectiveness of Systematic Echocardiographic Screening for Rheumatic Heart Disease in Nepalese Schoolchildren: A Cluster Randomized Clinical Trial.,"Importance Echocardiographic screening allows for early detection of subclinical stages of rheumatic heart disease among children in endemic regions. Objective To investigate the effectiveness of systematic echocardiographic screening in combination with secondary antibiotic prophylaxis on the prevalence of rheumatic heart disease. Design, Setting, and Participants This cluster randomized clinical trial included students 9 to 16 years of age attending public and private schools in urban and rural areas of the Sunsari district in Nepal that had been randomly selected on November 17, 2012. Echocardiographic follow-up was performed between January 7, 2016, and January 3, 2019. Interventions In the experimental group, children underwent systematic echocardiographic screening followed by secondary antibiotic prophylaxis in case they had echocardiographic evidence of latent rheumatic heart disease. In the control group, children underwent no echocardiographic screening. Main Outcomes and Measures Prevalence of the composite of definite or borderline rheumatic heart disease according to the World Heart Federation criteria in experimental and control schools as assessed 4 years after intervention. Results A total of 35 schools were randomized to the experimental group (n = 19) or the control group (n = 16). After a median of 4.3 years (interquartile range [IQR], 4.0-4.5 years), 17 of 19 schools in the experimental group (2648 children; median age at follow-up, 12.1 years; IQR, 10.3-12.5 years; 1308 [49.4%] male) and 15 of 16 schools in the control group (1325 children; median age at follow-up, 10.6 years; IQR, 10.0-12.5 years; 682 [51.5%] male) underwent echocardiographic follow-up. The prevalence of definite or borderline rheumatic heart disease was 10.8 per 1000 children (95% CI, 4.7-24.7) in the control group and 3.8 per 1000 children (95% CI, 1.5-9.8) in the experimental group (odds ratio, 0.34; 95% CI, 0.11-1.07; P = .06). The prevalence in the experimental group at baseline had been 12.9 per 1000 children (95% CI, 9.2-18.1). In the experimental group, the odds ratio of definite or borderline rheumatic heart disease at follow-up vs baseline was 0.29 (95% CI, 0.13-0.65; P = .008). Conclusions and Relevance School-based echocardiographic screening in combination with secondary antibiotic prophylaxis in children with evidence of latent rheumatic heart disease may be an effective strategy to reduce the prevalence of definite or borderline rheumatic heart disease in endemic regions. Trial Registration ClinicalTrials.gov Identifier: NCT01550068.",2021,"The prevalence of definite or borderline rheumatic heart disease was 10.8 per 1000 children (95% CI, 4.7-24.7) in the control group and 3.8 per 1000 children (95% CI, 1.5-9.8) in the experimental group (odds ratio, 0.34; 95% CI, 0.11-1.07; P = .06).","['19 schools in the experimental group (2648 children; median age at follow-up, 12.1 years; IQR, 10.3-12.5 years; 1308 [49.4%] male) and 15 of 16 schools in the control group (1325 children; median age at follow-up, 10.6 years; IQR, 10.0-12.5 years; 682 [51.5%] male) underwent echocardiographic follow-up', 'children with evidence of latent rheumatic heart disease', 'A total of 35 schools', 'students 9 to 16 years of age attending public and private schools in urban and rural areas of the Sunsari district in Nepal that had been randomly selected on November 17, 2012', 'Rheumatic Heart Disease in Nepalese Schoolchildren', 'children in endemic regions']","['systematic echocardiographic screening in combination with secondary antibiotic prophylaxis', 'Systematic Echocardiographic Screening', 'systematic echocardiographic screening followed by secondary antibiotic prophylaxis']","['Measures\n\n\nPrevalence of the composite of definite or borderline rheumatic heart disease according to the World Heart Federation criteria in experimental and control schools', 'prevalence of definite or borderline rheumatic heart disease', 'odds ratio of definite or borderline rheumatic heart disease']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0035439', 'cui_str': 'Rheumatic heart disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0243130', 'cui_str': 'endemics'}]","[{'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0035439', 'cui_str': 'Rheumatic heart disease'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",35.0,0.122688,"The prevalence of definite or borderline rheumatic heart disease was 10.8 per 1000 children (95% CI, 4.7-24.7) in the control group and 3.8 per 1000 children (95% CI, 1.5-9.8) in the experimental group (odds ratio, 0.34; 95% CI, 0.11-1.07; P = .06).","[{'ForeName': 'Prahlad', 'Initials': 'P', 'LastName': 'Karki', 'Affiliation': 'Department of Internal Medicine and Cardiology, B.P. Koirala Institute of Health Sciences, Dharan, Nepal.'}, {'ForeName': 'Surendra', 'Initials': 'S', 'LastName': 'Uranw', 'Affiliation': 'Department of Internal Medicine and Cardiology, B.P. Koirala Institute of Health Sciences, Dharan, Nepal.'}, {'ForeName': 'Santosh', 'Initials': 'S', 'LastName': 'Bastola', 'Affiliation': 'Department of Internal Medicine and Cardiology, B.P. Koirala Institute of Health Sciences, Dharan, Nepal.'}, {'ForeName': 'Rajan', 'Initials': 'R', 'LastName': 'Mahato', 'Affiliation': 'Department of Internal Medicine and Cardiology, B.P. Koirala Institute of Health Sciences, Dharan, Nepal.'}, {'ForeName': 'Nikesh Raj', 'Initials': 'NR', 'LastName': 'Shrestha', 'Affiliation': 'Department of Cardiology, Neuro Cardio and Multispeciality Hospital, Biratnagar, Nepal.'}, {'ForeName': 'Kunjang', 'Initials': 'K', 'LastName': 'Sherpa', 'Affiliation': 'Department of Internal Medicine and Cardiology, B.P. Koirala Institute of Health Sciences, Dharan, Nepal.'}, {'ForeName': 'Sahadeb', 'Initials': 'S', 'LastName': 'Dhungana', 'Affiliation': 'Noble Medical College Teaching Hospital and Research Center, Biratnagar, Nepal.'}, {'ForeName': 'Ayodele', 'Initials': 'A', 'LastName': 'Odutayo', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Department of Medicine and Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Keshar', 'Initials': 'K', 'LastName': 'Gurung', 'Affiliation': 'Department of Cardiology, Neuro Cardio and Multispeciality Hospital, Biratnagar, Nepal.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Pandey', 'Affiliation': 'Department of Internal Medicine and Cardiology, B.P. Koirala Institute of Health Sciences, Dharan, Nepal.'}, {'ForeName': 'Krishna', 'Initials': 'K', 'LastName': 'Agrawal', 'Affiliation': 'Department of Internal Medicine and Cardiology, B.P. Koirala Institute of Health Sciences, Dharan, Nepal.'}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Shah', 'Affiliation': 'Department of Internal Medicine and Cardiology, B.P. Koirala Institute of Health Sciences, Dharan, Nepal.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Rothenbühler', 'Affiliation': 'Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Department of Medicine and Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Pilgrim', 'Affiliation': 'Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland.'}]",JAMA cardiology,['10.1001/jamacardio.2020.7050'] 1959,33471788,A randomized clinical trial of a new anti-cervical stenosis device after conization by loop electrosurgical excision.,"BACKGROUND The complications inherent to conization include vaginal bleeding, cervical stenosis, amenorrhea, dysmenorrhea, and deep dyspareunia. Cervical stenosis is the most important complication due to the clinical repercussions. Studies show rates of cervical stenosis ranging from 1.3 to 19% after the Loop Electrosurgical Excision Procedure (LEEP). OBJECTIVE Our primary outcome was to compare the role of a new endocervical device to prevent cervical stenosis after LEEP in patients with high-grade squamous intraepithelial lesions (HSILs). METHODS A randomized clinical trial was performed including phases II and III for evaluation of a new device for cervical stenosis prevention. In Phase II, we included 25 patients who underwent LEEP and placement of the device to assess its toxicity and efficacy. In phase III, we compared two groups (with and without the use of an anti-stenosis device) to evaluate its efficacy and safety. RESULTS From August 2015 to June 2018, 265 participants were randomized (Phase II: 25, Phase III: 120 with DUDA and 120 without DUDA). The toxicity during phase II was observed in only one patient (4%) with pain grade > 7. There were 7 cases of toxicity during Phase III, 2 in the DUDA group (1.8%), and 5 in the No DUDA group (4.5%). The complications rate was numerically higher in the No DUDA group (2.5x higher) than the DUDA group, but this difference did not reach statistical significance (p = 0.52). The rate of cervical stenosis in DUDA group was (4-7,3%), and in No DUDA group was (4.3-5.8%) (p = 0.5). We did not find a significant difference when comparing the evolution at 3, 6, and 12 months in terms of cervical patency and visualization of the squamocolumnar junction (SCJ) during colposcopy. The DUDA group exhibited 15% to 19% nonvisualization of the SCJ, whereas that rate ranged from 10 to 12% in the No DUDA group. CONCLUSIONS The rate of cervical stenosis was not different comparing the use of a new device, specifically produced to prevent cervical stenosis, compared to no use after LEEP procedure. This clinical trial opens up space for a discussion of the utility of using cervical stenosis devices after LEEP. Perhaps in another type of conization it can be evaluated to avoid cervical stenosis.",2021,"The complications rate was numerically higher in the No DUDA group (2.5x higher) than the DUDA group, but this difference did not reach statistical significance (p = 0.52).","['25 patients who underwent', 'From August 2015 to June 2018, 265 participants were randomized ', 'patients with high-grade squamous intraepithelial lesions (HSILs']","['new anti-cervical stenosis device after conization by loop electrosurgical excision', 'LEEP', 'Loop Electrosurgical Excision Procedure (LEEP', 'new endocervical device']","['rates of cervical stenosis', 'toxicity and efficacy', 'complications rate', 'efficacy and safety', 'toxicity', 'rate of cervical stenosis', 'cervical patency and visualization of the squamocolumnar junction (SCJ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0333875', 'cui_str': 'High-grade squamous intraepithelial lesion'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0269199', 'cui_str': 'Stenosis of cervix'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0195324', 'cui_str': 'Cone biopsy of cervix'}, {'cui': 'C0184930', 'cui_str': 'Loop electrosurgical excision procedure'}, {'cui': 'C0227837', 'cui_str': 'Endocervical structure'}]","[{'cui': 'C0269199', 'cui_str': 'Stenosis of cervix'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}]",265.0,0.0504159,"The complications rate was numerically higher in the No DUDA group (2.5x higher) than the DUDA group, but this difference did not reach statistical significance (p = 0.52).","[{'ForeName': 'Marcelo de Andrade', 'Initials': 'MA', 'LastName': 'Vieira', 'Affiliation': 'Department of Gynecologic Oncology, Barretos Cancer Hospital, Barretos, São Paulo, Brazil.'}, {'ForeName': 'Raphael Leonardo Cunha', 'Initials': 'RLC', 'LastName': 'de Araújo', 'Affiliation': 'Department of Digestive Surgery, Escola Paulista de Medicina, Universidade Federal de São Paulo (UNIFESP), São Paulo, Brazil.'}, {'ForeName': 'Carlos Eduardo Mattos', 'Initials': 'CEM', 'LastName': 'da Cunha Andrade', 'Affiliation': 'Department of Gynecologic Oncology, Barretos Cancer Hospital, Barretos, São Paulo, Brazil.'}, {'ForeName': 'Ronaldo Luis', 'Initials': 'RL', 'LastName': 'Schmidt', 'Affiliation': 'Department of Gynecologic Oncology, Barretos Cancer Hospital, Barretos, São Paulo, Brazil.'}, {'ForeName': 'Agnaldo Lopes', 'Initials': 'AL', 'LastName': 'Filho', 'Affiliation': 'Department of Obstetrics and Gynecology, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Ricardo Dos', 'Initials': 'RD', 'LastName': 'Reis', 'Affiliation': 'Department of Gynecologic Oncology, Barretos Cancer Hospital, Barretos, São Paulo, Brazil.'}]",PloS one,['10.1371/journal.pone.0242067'] 1960,33493423,The ARREST Pneumonia Clinical Trial. Rationale and Design.,"Patients hospitalized for pneumonia are at high risk for mortality. Effective therapies are therefore needed. Recent randomized clinical trials suggest that systemic steroids can reduce the length of hospital stays among patients hospitalized for pneumonia. Furthermore, preliminary findings from a feasibility study demonstrated that early treatment with a combination of an inhaled corticosteroid and a bronchodilator can improve oxygenation and reduce risk of respiratory failure in patients at risk of acute respiratory distress syndrome. Whether such a combination administered early is effective in reducing acute respiratory failure (ARF) among patients hospitalized with pneumonia is unknown. Here we describe the ARREST Pneumonia (Arrest Respiratory Failure due to Pneumonia) trial designed to address this question. ARREST Pneumonia is a two-arm, randomized, double-blinded, placebo-controlled trial designed to test the efficacy of a combination of an inhaled corticosteroid and a β-agonist compared with placebo for the prevention of ARF in hospitalized participants with severe pneumonia. The primary outcome is ARF within 7 days of randomization, defined as a composite endpoint of intubation and mechanical ventilation; need for high-flow nasal cannula oxygen therapy or noninvasive ventilation for >36 hours (each alone or combined); or death within 36 hours of being placed on respiratory support. The planned enrollment is 600 adult participants at 10 academic medical centers. In addition, we will measure selected plasma biomarkers to better understand mechanisms of action. The trial is funded by the U.S. National Heart Lung and Blood Institute.Clinical trial registered with www.clinicaltrials.gov (NCT04193878).",2021,"The primary outcome is acute respiratory failure within 7 days of randomization, defined as a composite endpoint of intubation and mechanical ventilation, or need for high flow nasal cannula oxygen therapy or non-invasive ventilation for > 36 hours (each alone or combined), or death within 36 hours of being placed on respiratory support.","['600 adult participants at ten academic medical centers', 'patients hospitalized for pneumonia', 'patients at risk of acute respiratory distress syndrome', 'patients hospitalized with pneumonia', 'hospitalized participants with severe pneumonia', 'Patients hospitalized for pneumonia are at high risk for mortality']","['ARREST', 'systemic steroids', 'inhaled corticosteroid and a beta agonist', 'placebo']","['length of hospital stay', 'acute respiratory failure', 'acute respiratory failure within 7 days of randomization, defined as a composite endpoint of intubation and mechanical ventilation, or need for high flow nasal cannula oxygen therapy or non-invasive ventilation for > 36 hours (each alone or combined), or death within 36 hours of being placed on respiratory support']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]","[{'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C4761117', 'cui_str': 'High-flow nasal cannula oxygen therapy'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0183683', 'cui_str': 'Support'}]",600.0,0.659084,"The primary outcome is acute respiratory failure within 7 days of randomization, defined as a composite endpoint of intubation and mechanical ventilation, or need for high flow nasal cannula oxygen therapy or non-invasive ventilation for > 36 hours (each alone or combined), or death within 36 hours of being placed on respiratory support.","[{'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Levitt', 'Affiliation': 'Division of Pulmonary, Allergy and Critical Care Medicine.'}, {'ForeName': 'Emir', 'Initials': 'E', 'LastName': 'Festic', 'Affiliation': 'Division of Pulmonary Medicine and.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Desai', 'Affiliation': 'Stanford Center for Biomedical Informatics and Research, and.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Hedlin', 'Affiliation': 'Stanford Center for Biomedical Informatics and Research, and.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Stanford Center for Clinical Research, Stanford University, Stanford, California.'}, {'ForeName': 'Angela J', 'Initials': 'AJ', 'LastName': 'Rogers', 'Affiliation': 'Division of Pulmonary, Allergy and Critical Care Medicine.'}, {'ForeName': 'Ognjen', 'Initials': 'O', 'LastName': 'Gajic', 'Affiliation': 'Division of Pulmonary Medicine and.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Matthay', 'Affiliation': 'Pulmonary, Critical Care, Allergy and Sleep Medicine Program, University of California, San Francisco, San Francisco, California.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.202009-1115SD'] 1961,33493954,Effects of light-to-moderate intensity aerobic exercise on objectively measured sleep parameters among community-dwelling older people.,"OBJECTIVES Although exercise improves sleep parameters in older people, most studies have been designed for people with insomnia or sleep complaints. Little is known of the effects of exercise among older people without sleep problems. We investigated the effects of 3-month light-to-moderate intensity aerobic exercise intervention on objectively measured sleep quantity and quality among community-dwelling older people. METHODS Fifty-eight community-dwelling older people were assigned into an exercise (EX) or control (CON) groups, and 49 participants (65.7 ± 5.7 years. BMI 24.4 ± 3.9 kg/m 2 ) were enrolled in the analysis. EX group members attended 60 min/week group-based exercise program and performed ≥140 min of home-based exercise, at ≥50% of maximum heart rate to exceed 200 min of total exercise per week. Sleep was assessed by an accelerometer and the Pittsburgh Sleep Quality Index (PSQI) before and after intervention. RESULTS In the EX group, total sleep time, hours in waking after sleep onset, sleep efficiency and consecutive wake episodes ≥10 min (WE≥10 min) significantly improved (p<0.05). EX group showed a significantly greater reduction in WE≥10 min than the CON group (p<0.05). The subgroup analyses in the EX group according to baseline PSQI cutoff value showed no differences in changes between subgroups. CONCLUSIONS Three-month aerobic exercise improved objectively measured sleep quality in community-dwelling older people. Baseline sleep conditions did not significantly influence the magnitude of changes in sleep quality and quantity. These results suggest that light aerobic exercise can improve sleep among community-dwelling older people, regardless of baseline sleep status, but the effect may be small.",2021,EX group showed a significantly greater reduction in WE≥10 min than the CON group (p<0.05).,"['older people without sleep problems', 'older people', 'people with insomnia or sleep complaints', 'community-dwelling older people', 'Fifty-eight community-dwelling older people', 'groups, and 49 participants (65.7\xa0±\xa05.7 years']","['exercise (EX) or control (CON', 'light aerobic exercise', 'EX group members attended 60\xa0min/week group-based exercise program and performed ≥140\xa0min of home-based exercise, at ≥50% of maximum heart rate to exceed 200\xa0min of total exercise per week', 'light-to-moderate intensity aerobic exercise', 'light-to-moderate intensity aerobic exercise intervention', 'CON', 'aerobic exercise']","['sleep quality and quantity', 'Pittsburgh Sleep Quality Index (PSQI', 'Sleep', 'sleep quality', 'sleep parameters', 'sleep quantity and quality', 'total sleep time, hours in waking after sleep onset, sleep efficiency and consecutive wake episodes ≥10']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",,0.0335926,EX group showed a significantly greater reduction in WE≥10 min than the CON group (p<0.05).,"[{'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Miyazaki', 'Affiliation': 'Faculty of Human Sciences, Shimane University, 1060 Nishikawatsu, Matsue, Shimane 690-8504, Japan. Electronic address: miyazaki@hmn.shimane-u.ac.jp.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Ayabe', 'Affiliation': 'Faculty of Computer Science and Systems Engineering, Okayama Prefectural University, 111 Kuboki, Soja, Okayama, 719-1197, Japan. Electronic address: ayabe@ss.oka-pu.ac.jp.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Kumahara', 'Affiliation': 'Faculty of Nutritional Sciences, Nakamura Gakuen University, 5-7-1 Befu, Jounan-ku, Fukuoka 814-0198, Japan. Electronic address: kumahara@nakamura-u.ac.jp.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Morimura', 'Affiliation': 'Faculty of Education, Shujitsu University, 1-6-1 Nishigawara, Naka-ku, Okayama-shi, Okayama 703-8516, Japan. Electronic address: k_morimura@shujitsu.ac.jp.'}, {'ForeName': 'Yoshihide', 'Initials': 'Y', 'LastName': 'Inukai', 'Affiliation': 'Faculty of Computer Science and Systems Engineering, Okayama Prefectural University, 111 Kuboki, Soja, Okayama, 719-1197, Japan. Electronic address: Inukaiyoshihide@gmail.com.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104336'] 1962,33497643,Comparison of contrast-enhanced versus conventional EUS-guided FNA/fine-needle biopsy in diagnosis of solid pancreatic lesions: a randomized controlled trial.,"BACKGROUND AND AIMS Contrast-enhanced harmonic EUS (CEH-EUS) is useful in the differential diagnosis of solid pancreatic lesions (SPLs). However, there is lack of verification about the usefulness of CEH-EUS-guided FNA/fine-needle biopsy (FNB) sampling. This study aimed to investigate the usefulness of CEH-EUS-guided FNA/FNB sampling without on-site cytopathology. METHODS Patients with SPLs were prospectively enrolled and randomly assigned (1:1) to 2 parallel groups, the interventional group (CEH-EUS) or the control group (conventional EUS). The diagnostic sensitivity and optimal number of needle passes for pathologic diagnosis were investigated and compared between groups. RESULTS Two hundred forty patients were enrolled from March 2016 to September 2019, with 120 patients assigned to each group. Pancreatic malignancies and neuroendocrine tumors were found in 202 (90.83%) and 9 (3.75%) patients, respectively. There was no statistically significant difference between the groups in terms of age, sex, lesion size (30.96 ± 12.09 mm in the CEH-EUS group vs 33.09 ± 16.39 mm in the conventional EUS group; P = .252), lesion location, adverse event rate, and disease distribution. The diagnostic sensitivity values in the CEH-EUS and conventional EUS groups were 85.8% and 88.3%, respectively (P = .564). All patients in the conventional EUS group and most in the CEH-EUS group received a pathologic diagnosis within 3 needle passes. CONCLUSIONS Diagnostic sensitivity for SPLs was not different between the CEH-EUS and conventional EUS groups, and no independent factors were found that could improve diagnostic sensitivity. CEH-EUS-guided FNA/FNB sampling does not need to be used routinely and may be selectively considered for small, indeterminate lesions. (Clinical trial registration number: KCT 0001840.).",2021,"There was no statistically significant difference between the groups in terms of age, sex, lesion size (30.96±12.09 mm in the CEH-EUS group vs 33.09 ± 16.39 mm in the conventional EUS group; p=0.252), location, adverse event rate, and disease distribution.","['240 patients were enrolled from March 2016 to September 2019, with 120 patients assigned to each group', 'diagnosis of solid pancreatic lesions', 'Patients with SPLs']","['CEH-EUS-guided fine-needle aspiration/biopsy (FNA/B', 'interventional group (CEH-EUS) or control group (conventional EUS', 'CEH-EUS', 'contrast-enhanced versus conventional EUS-guided fine-needle aspiration/biopsy', 'harmonic endoscopic ultrasound (CEH-EUS', 'conventional EUS']","['diagnostic sensitivity', 'diagnostic sensitivity values', 'age, sex, lesion size', 'Pancreatic malignancies and neuroendocrine tumors', 'location, adverse event rate, and disease distribution']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C1880510', 'cui_str': 'EUS-FNA'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1510483', 'cui_str': 'Fine needle aspiration biopsy - action'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0449453', 'cui_str': 'Lesion size'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0206754', 'cui_str': 'Neuroendocrine tumor'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}]",240.0,0.0348527,"There was no statistically significant difference between the groups in terms of age, sex, lesion size (30.96±12.09 mm in the CEH-EUS group vs 33.09 ± 16.39 mm in the conventional EUS group; p=0.252), location, adverse event rate, and disease distribution.","[{'ForeName': 'In Rae', 'Initials': 'IR', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Seok-Hoo', 'Initials': 'SH', 'LastName': 'Jeong', 'Affiliation': ""Department of Internal Medicine, Catholic Kwandong University International Saint Mary's Hospital, Incheon, Korea.""}, {'ForeName': 'Huapyong', 'Initials': 'H', 'LastName': 'Kang', 'Affiliation': 'Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea.'}, {'ForeName': 'Eui Joo', 'Initials': 'EJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea.'}, {'ForeName': 'Yeon Suk', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea.'}, {'ForeName': 'Jae Hee', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2021.01.018'] 1963,33448933,Virtual Reality Relaxation for Patients With a Psychiatric Disorder: Crossover Randomized Controlled Trial.,"BACKGROUND Virtual reality (VR) relaxation is a promising mental health intervention that may be an effective tool for stress reduction but has hardly been tested in clinical trials with psychiatric patients. We developed an easy-to-use VR self-management relaxation tool (VRelax) with immersive 360° nature videos and interactive animated elements. OBJECTIVE To investigate the immediate effects of VR relaxation on negative and positive affective states and short-term effects on perceived stress and symptoms in patients with a psychiatric disorder, compared to standard relaxation exercises. METHODS A randomized crossover trial was conducted in 50 patients receiving ambulatory treatment for anxiety, psychotic, depressive, or bipolar disorder. Participants were randomly assigned to start with VRelax or standard relaxation and used both interventions for 10 days at home. They completed 8 visual analog scales of momentary negative and positive affective states before and after each session. Global perceived stress and psychiatric symptoms were measured before and after both intervention periods. Treatment effects were analyzed with multilevel mixed model regression analyses and 2-way analysis of variance. RESULTS Both VRelax and standard relaxation exercises led to a statistically significant immediate improvement of all negative and positive affective states. Compared to standard relaxation, VRelax resulted in a significantly greater reduction of total negative affective state (change 16.2% versus 21.2%; t 1684 =-2.02, 95% CI -18.70 to -0.28; P=.04). Specifically, VRelax had a stronger beneficial effect on momentary anxiety (t 1684 =-3.24, 95% CI -6.86 to -1.69), sadness (t 1684 =-2.32, 95% CI -6.51 to -0.55), and cheerfulness (t 1684 =2.35, 95% CI 0.51 to 5.75). There were no significant differences between short-term effects of the two treatments on global perceived stress and symptoms. CONCLUSIONS If the results of this trial are replicated and extended, VRelax may provide a much-needed, effective, easy-to-use self-management relaxation intervention to enhance psychiatric treatments. TRIAL REGISTRATION Netherlands Trial Register NTR7294; https://www.trialregister.nl/trial/7096.",2021,"Compared to standard relaxation, VRelax resulted in a significantly greater reduction of total negative affective state (change 16.2% versus 21.2%; t 1684 =","['Patients With a Psychiatric Disorder', 'patients with a psychiatric disorder', '50 patients receiving ambulatory treatment for anxiety, psychotic, depressive, or bipolar disorder']","['VRelax or standard relaxation', 'easy-to-use VR self-management relaxation tool (VRelax) with immersive 360° nature videos and interactive animated elements', 'Virtual reality (VR) relaxation', 'VR relaxation', 'VRelax and standard relaxation exercises', 'Virtual Reality Relaxation']","['total negative affective state', 'global perceived stress and symptoms', 'visual analog scales of momentary negative and positive affective states', 'momentary anxiety', 'Global perceived stress and psychiatric symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C0203993', 'cui_str': 'Relaxation exercise'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}]",,0.14889,"Compared to standard relaxation, VRelax resulted in a significantly greater reduction of total negative affective state (change 16.2% versus 21.2%; t 1684 =","[{'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Veling', 'Affiliation': 'Department of Psychiatry, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Lestestuiver', 'Affiliation': 'Department of Psychiatry, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Jongma', 'Affiliation': 'VRelax BV, Groningen, Netherlands.'}, {'ForeName': 'H J Rogier', 'Initials': 'HJR', 'LastName': 'Hoenders', 'Affiliation': 'Centre for Integrative Psychiatry, Lentis, Groningen, Netherlands.'}, {'ForeName': 'Catheleine', 'Initials': 'C', 'LastName': 'van Driel', 'Affiliation': 'Department of Psychiatry, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.'}]",Journal of medical Internet research,['10.2196/17233'] 1964,33460156,Relationship of regular physical activity with neuroelectric indices of interference processing in young adults.,"The relationship of physical activity with interference processing was examined using behavioral and neuroelectrical measures in young adults divided into more active and less active groups. The participants completed Stroop (i.e., color-naming) and reverse Stroop (i.e., word-meaning) tasks that differed in the level of difficulty while event-related potentials were assessed. In the low interference Stroop task, participants were asked to respond to the ink color of the word, while the meaning was either congruent or incongruent with the color. In the high interference reverse Stroop task, participants had to indicate the meaning of colored words while ignoring the color of the font. The results indicated that young adults in the more active group exhibited a shorter response time (RT) and a lower intra-individual variability of RT than did those in the less active group. These behavioral differences were associated with larger P2 and P3 and smaller N450 amplitudes in the Stroop task and with larger P2 and N2 and smaller N450 amplitudes in the reverse Stroop task. No differences were observed in the contingent negative variation (CNV) between the groups. These findings suggest that, for young adults, regular physical activity is positively associated with a better neural efficiency in resource allocation for tasks that require the ability to inhibit cognitive interference and provide evidence for the potential neural mechanisms underlying the improved Stroop performance.",2020,These behavioral differences were associated with larger P2 and P3 and smaller N450 amplitudes in the Stroop task and with larger P2 and N2 and smaller N450 amplitudes in the reverse Stroop task.,"['young adults', 'young adults divided into more active and less active groups']",[],"['shorter response time (RT) and a lower intra-individual variability of RT', 'contingent negative variation (CNV']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009850', 'cui_str': 'Contingent negative variation'}]",,0.0205117,These behavioral differences were associated with larger P2 and P3 and smaller N450 amplitudes in the Stroop task and with larger P2 and N2 and smaller N450 amplitudes in the reverse Stroop task.,"[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Aly', 'Affiliation': 'Department of Psychology, Institute of Human and Social Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Haruyuki', 'Initials': 'H', 'LastName': 'Kojima', 'Affiliation': 'Department of Psychology, Institute of Human and Social Sciences, Kanazawa University, Kanazawa, Japan.'}]",Psychophysiology,['10.1111/psyp.13674'] 1965,33471240,Preservation of kidney function irrelevant of total kidney volume growth rate with tolvaptan treatment in patients with autosomal dominant polycystic kidney disease.,"BACKGROUND Tolvaptan slowed the rates of total kidney volume (TKV) growth and renal function decline over a 3-year period in patients with autosomal dominant polycystic kidney disease (ADPKD) enrolled in the Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and Its Outcomes (TEMPO) 3:4 trial (NCT00428948). In this post hoc analysis of Japanese patients from TEMPO 3:4, we evaluated whether the effects of tolvaptan on TKV and on renal function are interrelated. METHODS One hundred and forty-seven Japanese patients from TEMPO 3:4 were included in this analysis (placebo, n = 55; tolvaptan, n = 92). Tolvaptan-treated patients were stratified into the responder group (n = 37), defined as tolvaptan-treated patients with a net decrease in TKV from baseline to year 3, and the non-responder group (n = 55), defined as tolvaptan-treated patients with a net increase in TKV. RESULTS Mean changes during follow-up in the placebo, responder, and non-responder groups were 16.99%, - 8.33%, and 13.95%, respectively, for TKV and - 12.61, - 8.47, and - 8.58 mL/min/1.73 m 2 , respectively, for estimated glomerular filtration rate (eGFR). Compared with the placebo group, eGFR decline was significantly slowed in both the responder and non-responder groups (P < 0.05). CONCLUSION Tolvaptan was effective in slowing eGFR decline, regardless of TKV response, over 3 years in patients with ADPKD in Japan. Treatment with tolvaptan may have beneficial effects on slowing of renal function decline even in patients who have not experienced a reduction in the rate of TKV growth by treatment with tolvaptan.",2021,"Mean changes during follow-up in the placebo, responder, and non-responder groups were 16.99%, - 8.33%, and 13.95%, respectively, for TKV and - 12.61, - 8.47, and - 8.58 ","['Japanese patients', 'One hundred and forty-seven Japanese patients from TEMPO 3:4 were included in this analysis (placebo, n\u2009=\u200955; tolvaptan, n\u2009=\u200992', 'patients with autosomal dominant polycystic kidney disease (ADPKD', 'patients with ADPKD in Japan', 'patients with autosomal dominant polycystic kidney disease']","['placebo', 'tolvaptan', 'Tolvaptan', 'tolvaptan-treated patients with a net increase in TKV', 'tolvaptan treatment']","['glomerular filtration rate (eGFR', 'slowing eGFR decline, regardless of TKV response', 'Mean changes', 'eGFR decline', 'total kidney volume (TKV) growth and renal function decline']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0076084', 'cui_str': '2,2,6,6-tetramethyl-4-piperidine-N-oxide'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C0085413', 'cui_str': 'Autosomal dominant polycystic kidney disease'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}]",147.0,0.0331217,"Mean changes during follow-up in the placebo, responder, and non-responder groups were 16.99%, - 8.33%, and 13.95%, respectively, for TKV and - 12.61, - 8.47, and - 8.58 ","[{'ForeName': 'Shigeo', 'Initials': 'S', 'LastName': 'Horie', 'Affiliation': 'Department of Urology, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan. shorie@juntendo.ac.jp.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Muto', 'Affiliation': 'Department of Urology, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan.'}, {'ForeName': 'Haruna', 'Initials': 'H', 'LastName': 'Kawano', 'Affiliation': 'Department of Urology, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Okada', 'Affiliation': 'Department of Clinical Development, Otsuka Pharmaceutical Co., Ltd, Osaka, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Shibasaki', 'Affiliation': 'Medical Affairs, Otsuka Pharmaceutical Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Nakajima', 'Affiliation': 'Medical Affairs, Otsuka Pharmaceutical Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Tatsuki', 'Initials': 'T', 'LastName': 'Ibuki', 'Affiliation': 'Medical Affairs, Otsuka Pharmaceutical Co., Ltd, Tokyo, Japan.'}]",Clinical and experimental nephrology,['10.1007/s10157-020-02009-0'] 1966,33470602,Efficacy of Rest Redistribution During Squats: Considerations for Strength and Sex.,"ABSTRACT Boffey, D, Clark, NW, and Fukuda, DH. Efficacy of rest redistribution during squats: Considerations for strength and sex. J Strength Cond Res 35(3): 586-595, 2021-This study examined the kinematic, perceptual, and heart rate responses to rest redistribution (RR) and traditional sets (TS) during the barbell back squat for men and women possessing a wide range of strength levels. Forty-five resistance-trained subjects (30 men and 15 women) performed 40 repetitions of the barbell squat with 65% 1RM load with TS (4 × 10 repetitions, 3-minute rest) or RR (10 × 4 repetitions, 1-minute rest), in a randomized order on days separated by ≥72 hours. The significance was set at p ≤ 0.05 for all statistical analyses. The mean velocity (MV) maintenance was significantly higher for RR compared with TS (87.70 ± 4.50% vs. 84.07 ± 4.48%, respectively; p < 0.01, d = 0.35). Rating of perceived exertion (active muscles) was significantly lower for RR compared with TS (5.38 ± 1.42 vs. 6.08 ± 1.43, respectively; p = 0.02, d = -0.35). Rating of perceived exertion (overall) was also significantly lower for RR compared with TS (5.60 ± 1.40 vs. 6.48 ± 1.49, respectively; p = 0.02, d = -0.37). The relative strength ratio (relative strength ratio; squat 1RM: body mass) was significantly correlated with the difference in MV maintenance between RR and TS (r = -0.34, p = 0.02). No sex-based differences (p > 0.05) were found for any dependent variables. Rest redistribution produced significantly higher mean HR (143.25 ± 21.11 vs. 135.05 ± 20.74, p < 0.01) and minimum HR (102.77 ± 19.58 vs. 95.97 ± 22.17, p < 0.01). Subjects were better able to maintain velocity with RR compared with TS, while experiencing less perceived effort. Rest redistribution can be recommended for both men and women, but very strong individuals may not improve their velocity maintenance with RR to the same extent as less strong individuals.",2021,"The relative strength ratio (relative strength ratio; squat 1RM: body mass) was significantly correlated with the difference in MV maintenance between RR and TS (r = -0.34, p = 0.02).",['Forty-five resistance-trained subjects (30 men and 15 women) performed'],"['Rest Redistribution', '40 repetitions of the barbell squat with 65% 1RM load with TS (4 × 10 repetitions, 3-minute rest) or RR', 'J Strength Cond Res XX(X']","['Rating of perceived exertion (overall', 'relative strength ratio', 'kinematic, perceptual, and heart rate responses to rest redistribution (RR) and traditional sets (TS', 'mean velocity (MV) maintenance', 'Rating of perceived exertion (active muscles', 'MV maintenance']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0332620', 'cui_str': 'Redistribution'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C1997754', 'cui_str': 'Heart rate response'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0332620', 'cui_str': 'Redistribution'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",,0.0969138,"The relative strength ratio (relative strength ratio; squat 1RM: body mass) was significantly correlated with the difference in MV maintenance between RR and TS (r = -0.34, p = 0.02).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Boffey', 'Affiliation': 'Physiology of Work and Exercise Response (POWER) Laboratory, Institute of Exercise Physiology and Rehabilitation Science, University of Central Florida, Orlando, Florida; and.'}, {'ForeName': 'Nicolas W', 'Initials': 'NW', 'LastName': 'Clark', 'Affiliation': 'Physiology of Work and Exercise Response (POWER) Laboratory, Institute of Exercise Physiology and Rehabilitation Science, University of Central Florida, Orlando, Florida; and.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Fukuda', 'Affiliation': 'Physiology of Work and Exercise Response (POWER) Laboratory, Institute of Exercise Physiology and Rehabilitation Science, University of Central Florida, Orlando, Florida; and.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003893'] 1967,33470595,Reverse or Hemi Shoulder Arthroplasty in Proximal Humerus Fractures: A Single-Blinded Prospective Multicenter Randomized Clinical Trial.,"OBJECTIVES To compare outcomes between hemiarthroplasty (HA) and reversed shoulder arthroplasty (RSA) as a treatment for dislocated 3-part and 4-part proximal humerus fractures in the elderly population. DESIGN Prospective multicenter randomized controlled trial. SETTING Three Level-1 trauma centers. PATIENTS/PARTICIPANTS This study included 31 patients of which 14 were randomized into the HA group and 17 into the RSA group. INTERVENTION Patients randomized to the HA group were treated with a cemented-stem Aequalis-fracture HA and patients randomized to the RSA group with a cemented-stem Aequalis-fracture RSA. MAIN OUTCOME MEASUREMENTS Primary outcomes consisted of range of motion and constant score. Secondary outcomes were the visual analog scale for pain, DASH score, SF-12 scores, and radiographic outcomes. RESULTS After 6 and 12 months of follow-up, RSA showed a significant higher anterior elevation (105 degrees vs. 80 degrees, P = 0.002 and 110 degrees vs. 90 degrees, P = 0.02, respectively) and constant score (60 vs. 41, P = 0.01 and 51 vs. 32, P = 0.05, respectively) compared with HA. There were no significant differences in external and internal rotation. Also, visual analog scale pain, DASH scores, SF-12 scores, and radiological healing of the tuberosities and heterotopic ossification did not show any significant differences between groups. CONCLUSION RSA showed significant superior functional outcomes for anterior elevation and constant score compared with HA for dislocated 3-part and 4-part proximal humerus fractures after short-term follow-up. LEVEL OF EVIDENCE Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.",2021,"RSA showed significant superior functional outcomes for anterior elevation and Constant score compared to HA for dislocated three-part and four-part proximal humerus fractures after short term follow-up. ","['31 patients of which 14 were randomized into the HA group and 17 into the RSA group', 'Three level-1 trauma centers', 'dislocated three-part and four-part proximal humerus fractures in the elderly population', 'proximal humerus fractures']","['RSA', 'hemiarthroplasty (HA) and reversed shoulder arthroplasty (RSA', 'cemented-stem Aequalis-fracture hemiarthroplasty', 'Reverse or hemi shoulder arthroplasty', 'RSA group with a cemented-stem Aequalis-fracture reversed shoulder arthroplasty']","['anterior elevation', 'Range of Motion (ROM) and Constant score', 'VAS for pain, DASH score, SF-12 scores and radiographic outcomes', 'VAS-pain, DASH scores, SF-12 scores and radiological healing of the tuberosities and heterotopic ossification', 'Constant score', 'external and internal rotation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0186662', 'cui_str': 'Arthroplasty of shoulder'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0012691', 'cui_str': 'Dislocation'}, {'cui': 'C0588209', 'cui_str': 'Bone structure of proximal humerus'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0186662', 'cui_str': 'Arthroplasty of shoulder'}, {'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C1285521', 'cui_str': 'Hemi'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0029396', 'cui_str': 'Heterotopic ossification'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}]",14.0,0.120898,"RSA showed significant superior functional outcomes for anterior elevation and Constant score compared to HA for dislocated three-part and four-part proximal humerus fractures after short term follow-up. ","[{'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Laas', 'Affiliation': 'Department of Orthopaedic Surgery, Northwest Clinics, Alkmaar, the Netherlands.'}, {'ForeName': 'Yde', 'Initials': 'Y', 'LastName': 'Engelsma', 'Affiliation': 'Department of Orthopaedic Surgery, Northwest Clinics, Alkmaar, the Netherlands.'}, {'ForeName': 'Frans J A', 'Initials': 'FJA', 'LastName': 'Hagemans', 'Affiliation': 'Department of Orthopaedic Surgery, Northwest Clinics, Alkmaar, the Netherlands.'}, {'ForeName': 'Max A', 'Initials': 'MA', 'LastName': 'Hoelen', 'Affiliation': 'Department of Orthopaedic Surgery, Reinier de Graaf Hospital, Delft, the Netherlands; and.'}, {'ForeName': 'Derek F P', 'Initials': 'DFP', 'LastName': 'van Deurzen', 'Affiliation': 'Department of Orthopaedic Surgery, Onze Lieve Vrouwe Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Bart J', 'Initials': 'BJ', 'LastName': 'Burger', 'Affiliation': 'Department of Orthopaedic Surgery, Northwest Clinics, Alkmaar, the Netherlands.'}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001978'] 1968,33469713,Home phototherapy for hyperbilirubinemia in term neonates-an unblinded multicentre randomized controlled trial.,"The aim of this study was to assess whether home phototherapy was feasible and safe in a cohort of otherwise healthy term-born neonates who fulfilled the criteria for in-hospital phototherapy. This was a randomized controlled trial in which term newborns with a total serum bilirubin of 18-24 mg/dL (300-400 μmol) were randomized to either home phototherapy or conventional in-hospital phototherapy. The primary outcome measurements were safety and efficacy, length of stay and the number of failed treatments. The secondary outcomes were the number of blood samples and weight gain during treatment. One hundred forty-seven patients were recruited, 69 patients randomized to conventional phototherapy and 78 to home phototherapy. The results showed that no patients needed blood exchange and only 4% of the patients allocated to home phototherapy were admitted to the hospital. The duration of phototherapy, length of stay, amount of blood tests and weight change showed no statically significant differences.Conclusion: Home phototherapy could be a safe alternative to inpatient phototherapy for otherwise healthy newborns with hyperbilirubinemia if daily checkups and 24/7 telephone support can be provided. The parents should be informed to contact the hospital immediately if they fail to perform the treatment at home.Trial registration: Clinicaltrials.gov NCT03536078 What is Known: • Phototherapy in the hospital is a safe and effective treatment without major side effects. • Fibre optic equipment has made the choice of home phototherapy possible. What is New: • This is the first randomized controlled trial comparing home phototherapy with hospital phototherapy. • Results indicate that home phototherapy could be considered as a safe and feasible alternative when performed according to instructions given, to hospital treatment for otherwise healthy term newborns.",2021,"The duration of phototherapy, length of stay, amount of blood tests and weight change showed no statically significant differences.","['One hundred forty-seven patients were recruited, 69 patients randomized to', 'otherwise healthy term-born neonates who fulfilled the criteria for in-hospital phototherapy', 'term newborns with a total serum bilirubin of 18-24 mg/dL (300-400 μmol']","['home phototherapy with hospital phototherapy', 'Phototherapy', 'conventional phototherapy and 78 to home phototherapy', 'home phototherapy or conventional in-hospital phototherapy', 'Home phototherapy', 'home phototherapy']","['duration of phototherapy, length of stay, amount of blood tests and weight change', 'blood exchange', 'safety and efficacy, length of stay and the number of failed treatments', 'number of blood samples and weight gain']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1278039', 'cui_str': 'Serum total bilirubin measurement'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816746', 'cui_str': '400'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",147.0,0.111185,"The duration of phototherapy, length of stay, amount of blood tests and weight change showed no statically significant differences.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pettersson', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine and Health, Örebro University, S-701 85, Örebro, Sweden. miriam.pettersson@regionorebrolan.se.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Eriksson', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine and Health, Örebro University, S-701 85, Örebro, Sweden.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Albinsson', 'Affiliation': 'Department of Pediatrics, Karlstad Hospital, Karlstad, Sweden.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ohlin', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine and Health, Örebro University, S-701 85, Örebro, Sweden.'}]",European journal of pediatrics,['10.1007/s00431-021-03932-4'] 1969,33475701,Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19: A Randomized Clinical Trial.,"Importance Coronavirus disease 2019 (COVID-19) continues to spread rapidly worldwide. Neutralizing antibodies are a potential treatment for COVID-19. Objective To determine the effect of bamlanivimab monotherapy and combination therapy with bamlanivimab and etesevimab on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load in mild to moderate COVID-19. Design, Setting, and Participants The BLAZE-1 study is a randomized phase 2/3 trial at 49 US centers including ambulatory patients (N = 613) who tested positive for SARS-CoV-2 infection and had 1 or more mild to moderate symptoms. Patients who received bamlanivimab monotherapy or placebo were enrolled first (June 17-August 21, 2020) followed by patients who received bamlanivimab and etesevimab or placebo (August 22-September 3). These are the final analyses and represent findings through October 6, 2020. Interventions Patients were randomized to receive a single infusion of bamlanivimab (700 mg [n = 101], 2800 mg [n = 107], or 7000 mg [n = 101]), the combination treatment (2800 mg of bamlanivimab and 2800 mg of etesevimab [n = 112]), or placebo (n = 156). Main Outcomes and Measures The primary end point was change in SARS-CoV-2 log viral load at day 11 (±4 days). Nine prespecified secondary outcome measures were evaluated with comparisons between each treatment group and placebo, and included 3 other measures of viral load, 5 on symptoms, and 1 measure of clinical outcome (the proportion of patients with a COVID-19-related hospitalization, an emergency department [ED] visit, or death at day 29). Results Among the 577 patients who were randomized and received an infusion (mean age, 44.7 [SD, 15.7] years; 315 [54.6%] women), 533 (92.4%) completed the efficacy evaluation period (day 29). The change in log viral load from baseline at day 11 was -3.72 for 700 mg, -4.08 for 2800 mg, -3.49 for 7000 mg, -4.37 for combination treatment, and -3.80 for placebo. Compared with placebo, the differences in the change in log viral load at day 11 were 0.09 (95% CI, -0.35 to 0.52; P = .69) for 700 mg, -0.27 (95% CI, -0.71 to 0.16; P = .21) for 2800 mg, 0.31 (95% CI, -0.13 to 0.76; P = .16) for 7000 mg, and -0.57 (95% CI, -1.00 to -0.14; P = .01) for combination treatment. Among the secondary outcome measures, differences between each treatment group vs the placebo group were statistically significant for 10 of 84 end points. The proportion of patients with COVID-19-related hospitalizations or ED visits was 5.8% (9 events) for placebo, 1.0% (1 event) for 700 mg, 1.9% (2 events) for 2800 mg, 2.0% (2 events) for 7000 mg, and 0.9% (1 event) for combination treatment. Immediate hypersensitivity reactions were reported in 9 patients (6 bamlanivimab, 2 combination treatment, and 1 placebo). No deaths occurred during the study treatment. Conclusions and Relevance Among nonhospitalized patients with mild to moderate COVID-19 illness, treatment with bamlanivimab and etesevimab, compared with placebo, was associated with a statistically significant reduction in SARS-CoV-2 viral load at day 11; no significant difference in viral load reduction was observed for bamlanivimab monotherapy. Further ongoing clinical trials will focus on assessing the clinical benefit of antispike neutralizing antibodies in patients with COVID-19 as a primary end point. Trial Registration ClinicalTrials.gov Identifier: NCT04427501.",2021,"Compared with placebo, the differences in the change in log viral load at day 11 were 0.09 (95% CI, -0.35 to 0.52; P = .69) for 700 mg, -0.27 (95% CI, -0.71 to 0.16; P = .21) for 2800 mg, 0.31 (95% CI, -0.13 to 0.76; P = .16) for 7000 mg, and -0.57 (95% CI, -1.00 to -0.14; P = .01) for combination treatment.","['Patients', 'patients with COVID-19 as a primary end point', '577 patients who were randomized and received an infusion (mean age, 44.7 [SD, 15.7] years; 315 [54.6%] women), 533 (92.4%) completed the efficacy evaluation period (day 29', 'mild to moderate COVID-19', '49 US centers including ambulatory patients (N\u2009=\u2009613) who tested positive for SARS-CoV-2 infection and had 1 or more mild to moderate symptoms']","['placebo', 'combination treatment (2800 mg of bamlanivimab and 2800 mg of etesevimab [n\u2009=\u2009112]), or placebo', 'Bamlanivimab', 'bamlanivimab monotherapy or placebo', 'bamlanivimab monotherapy and combination therapy with bamlanivimab and etesevimab', 'bamlanivimab', 'bamlanivimab and etesevimab or placebo']","['log viral load', 'viral load reduction', 'viral load, 5 on symptoms, and 1 measure of clinical outcome (the proportion of patients with a COVID-19-related hospitalization, an emergency department [ED] visit, or death at day 29', 'Immediate hypersensitivity reactions', 'SARS-CoV-2 viral load', 'change in SARS-CoV-2 log viral load', 'deaths', 'proportion of patients with COVID-19-related hospitalizations or ED visits']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517680', 'cui_str': '2800'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0020523', 'cui_str': 'IgE-mediated allergic disorder'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",,0.45133,"Compared with placebo, the differences in the change in log viral load at day 11 were 0.09 (95% CI, -0.35 to 0.52; P = .69) for 700 mg, -0.27 (95% CI, -0.71 to 0.16; P = .21) for 2800 mg, 0.31 (95% CI, -0.13 to 0.76; P = .16) for 7000 mg, and -0.57 (95% CI, -1.00 to -0.14; P = .01) for combination treatment.","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Gottlieb', 'Affiliation': 'Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas, Texas.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Nirula', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': ""Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles, California.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Boscia', 'Affiliation': 'Vitalink Research, Union, South Carolina.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Heller', 'Affiliation': 'Long Beach Clinical Trials, Long Beach, California.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Morris', 'Affiliation': 'Imperial Health, Lake Charles, Louisiana.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Huhn', 'Affiliation': 'Cook County Health, Chicago, Illinois.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Cardona', 'Affiliation': 'Indago Research, Hialeah, Florida.'}, {'ForeName': 'Bharat', 'Initials': 'B', 'LastName': 'Mocherla', 'Affiliation': 'Las Vegas Medical Research Center, Las Vegas, Nevada.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Stosor', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Imad', 'Initials': 'I', 'LastName': 'Shawa', 'Affiliation': 'Franciscan Health, Greenwood, Indiana.'}, {'ForeName': 'Princy', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': 'Georgetown University, Washington, DC.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Adams', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Van Naarden', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Kenneth L', 'Initials': 'KL', 'LastName': 'Custer', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Durante', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Oakley', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Schade', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Holzer', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Ebert', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Higgs', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Kallewaard', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Janelle', 'Initials': 'J', 'LastName': 'Sabo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Dipak R', 'Initials': 'DR', 'LastName': 'Patel', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Klekotka', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Skovronsky', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}]",JAMA,['10.1001/jama.2021.0202'] 1970,33452295,MLIP genotype as a predictor of pharmacological response in primary open-angle glaucoma and ocular hypertension.,"Predicting the therapeutic response to ocular hypotensive drugs is crucial for the clinical treatment and management of glaucoma. Our aim was to identify a possible genetic contribution to the response to current pharmacological treatments of choice in a white Mediterranean population with primary open-angle glaucoma (POAG) or ocular hypertension (OH). We conducted a prospective, controlled, randomized, partial crossover study that included 151 patients of both genders, aged 18 years and older, diagnosed with and requiring pharmacological treatment for POAG or OH in one or both eyes. We sought to identify copy number variants (CNVs) associated with differences in pharmacological response, using a DNA pooling strategy of carefully phenotyped treatment responders and non-responders, treated for a minimum of 6 weeks with a beta-blocker (timolol maleate) and/or prostaglandin analog (latanoprost). Diurnal intraocular pressure reduction and comparative genome wide CNVs were analyzed. Our finding that copy number alleles of an intronic portion of the MLIP gene is a predictor of pharmacological response to beta blockers and prostaglandin analogs could be used as a biomarker to guide first-tier POAG and OH treatment. Our finding improves understanding of the genetic factors modulating pharmacological response in POAG and OH, and represents an important contribution to the establishment of a personalized approach to the treatment of glaucoma.",2021,Our finding that copy number alleles of an intronic portion of the MLIP gene is a predictor of pharmacological response to beta blockers and prostaglandin analogs could be used as a biomarker to guide first-tier POAG and OH treatment.,"['151 patients of both genders, aged 18\xa0years and older, diagnosed with and requiring pharmacological treatment for POAG or OH in one or both eyes', 'white Mediterranean population with primary open-angle glaucoma (POAG) or ocular hypertension (OH']","['beta-blocker (timolol maleate', 'prostaglandin analog (latanoprost']",['Diurnal intraocular pressure reduction and comparative genome wide CNVs'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C0028840', 'cui_str': 'Ocular hypertension'}, {'cui': 'C0229118', 'cui_str': 'Structure of both eyes'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}, {'cui': 'C0087093', 'cui_str': 'Timolol maleate'}, {'cui': 'C0033568', 'cui_str': 'Prostaglandin analog'}, {'cui': 'C0090306', 'cui_str': 'latanoprost'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C1511518', 'cui_str': 'Copy Number Polymorphisms'}]",151.0,0.0228742,Our finding that copy number alleles of an intronic portion of the MLIP gene is a predictor of pharmacological response to beta blockers and prostaglandin analogs could be used as a biomarker to guide first-tier POAG and OH treatment.,"[{'ForeName': 'María I', 'Initials': 'MI', 'LastName': 'Canut', 'Affiliation': 'Centro de Oftalmología Barraquer, Instituto Universitario Barraquer (UAB), Barcelona, Spain.'}, {'ForeName': 'Olaya', 'Initials': 'O', 'LastName': 'Villa', 'Affiliation': 'Quantitative Genomic Medicine Laboratories (qGenomics), Esplugues del Llobregat, Spain.'}, {'ForeName': 'Bachar', 'Initials': 'B', 'LastName': 'Kudsieh', 'Affiliation': 'Hospital Universitario Puerta de Hierro, Madrid, Spain.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Mattlin', 'Affiliation': 'Quantitative Genomic Medicine Laboratories (qGenomics), Esplugues del Llobregat, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Banchs', 'Affiliation': 'Quantitative Genomic Medicine Laboratories (qGenomics), Esplugues del Llobregat, Spain.'}, {'ForeName': 'Juan R', 'Initials': 'JR', 'LastName': 'González', 'Affiliation': 'Barcelona Institute for Global Health (ISGlobal) and Centro de Investigación Biomédica en Red en Epidemiologia Y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'Lluís', 'Initials': 'L', 'LastName': 'Armengol', 'Affiliation': 'Quantitative Genomic Medicine Laboratories (qGenomics), Esplugues del Llobregat, Spain. luis.armengol@qgenomics.com.'}, {'ForeName': 'Ricardo P', 'Initials': 'RP', 'LastName': 'Casaroli-Marano', 'Affiliation': 'Department of Surgery, School of Medicine and Health Sciences and Hospital Clinic de Barcelona (IDIBAPS), University of Barcelona, Calle Sabino de Arana 1 (2nd floor, Ophthalmology), 08028, Barcelona, Spain. rcasaroli@ub.edu.'}]",Scientific reports,['10.1038/s41598-020-80954-2'] 1971,33480963,Efficacy of Margetuximab vs Trastuzumab in Patients With Pretreated ERBB2-Positive Advanced Breast Cancer: A Phase 3 Randomized Clinical Trial.,"Importance ERRB2 (formerly HER2)-positive advanced breast cancer (ABC) remains typically incurable with optimal treatment undefined in later lines of therapy. The chimeric antibody margetuximab shares ERBB2 specificity with trastuzumab but incorporates an engineered Fc region to increase immune activation. Objective To compare the clinical efficacy of margetuximab vs trastuzumab, each with chemotherapy, in patients with pretreated ERBB2-positive ABC. Design, Setting, and Participants The SOPHIA phase 3 randomized open-label trial of margetuximab plus chemotherapy vs trastuzumab plus chemotherapy enrolled 536 patients from August 26, 2015, to October 10, 2018, at 166 sites in 17 countries. Eligible patients had disease progression on 2 or more prior anti-ERBB2 therapies and 1 to 3 lines of therapy for metastatic disease. Data were analyzed from February 2019 to October 2019. Interventions Investigators selected chemotherapy before 1:1 randomization to margetuximab, 15 mg/kg, or trastuzumab, 6 mg/kg (loading dose, 8 mg/kg), each in 3-week cycles. Stratification factors were metastatic sites (≤2, >2), lines of therapy (≤2, >2), and chemotherapy choice. Main Outcomes and Measures Sequential primary end points were progression-free survival (PFS) by central blinded analysis and overall survival (OS). All α was allocated to PFS, followed by OS. Secondary end points were investigator-assessed PFS and objective response rate by central blinded analysis. Results A total of 536 patients were randomized to receive margetuximab (n = 266) or trastuzumab (n = 270). The median age was 56 (27-86) years; 266 (100%) women were in the margetuximab group, while 267 (98.9%) women were in the trastuzumab group. Groups were balanced. All but 1 patient had received prior pertuzumab, and 489 (91.2%) had received prior ado-trastuzumab emtansine. Margetuximab improved primary PFS over trastuzumab with 24% relative risk reduction (hazard ratio [HR], 0.76; 95% CI, 0.59-0.98; P = .03; median, 5.8 [95% CI, 5.5-7.0] months vs 4.9 [95% CI, 4.2-5.6] months; October 10, 2018). After the second planned interim analysis of 270 deaths, median OS was 21.6 months with margetuximab vs 19.8 months with trastuzumab (HR, 0.89; 95% CI, 0.69-1.13; P = .33; September 10, 2019), and investigator-assessed PFS showed 29% relative risk reduction favoring margetuximab (HR, 0.71; 95% CI, 0.58-0.86; P < .001; median, 5.7 vs 4.4 months; September 10, 2019). Margetuximab improved objective response rate over trastuzumab: 22% vs 16% (P = .06; October 10, 2018), and 25% vs 14% (P < .001; September 10, 2019). Incidence of infusion-related reactions, mostly in cycle 1, was higher with margetuximab (35 [13.3%] vs 9 [3.4%]); otherwise, safety was comparable. Conclusions and Relevance In this phase 3 randomized clinical trial, margetuximab plus chemotherapy had acceptable safety and a statistically significant improvement in PFS compared with trastuzumab plus chemotherapy in ERBB2-positive ABC after progression on 2 or more prior anti-ERBB2 therapies. Final OS analysis is expected in 2021. Trial Registration ClinicalTrials.gov Identifier: NCT02492711.",2021,"Margetuximab improved objective response rate over trastuzumab: 22% vs 16% (P = .06; October 10, 2018), and 25% vs 14% (P < .001; September 10, 2019).","['Patients With Pretreated ERBB2-Positive Advanced Breast Cancer', 'Eligible patients had disease progression on 2 or more prior anti-ERBB2 therapies and 1 to 3 lines of therapy for metastatic disease', '536 patients', 'patients with pretreated ERBB2-positive ABC', 'The median age was 56 (27-86) years; 266 (100%) women were in the margetuximab group, while 267 (98.9', 'enrolled 536 patients from August 26, 2015, to October 10, 2018, at 166 sites in 17 countries']","['margetuximab plus chemotherapy vs trastuzumab plus chemotherapy', 'margetuximab plus chemotherapy', 'trastuzumab plus chemotherapy', 'ERRB2', 'Margetuximab vs Trastuzumab', 'trastuzumab', 'margetuximab vs trastuzumab', 'margetuximab']","['PFS', 'progression-free survival (PFS) by central blinded analysis and overall survival (OS', 'investigator-assessed PFS and objective response rate by central blinded analysis', 'median OS', 'Incidence of infusion-related reactions', 'objective response rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4053695', 'cui_str': 'margetuximab'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C4053695', 'cui_str': 'margetuximab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",536.0,0.255236,"Margetuximab improved objective response rate over trastuzumab: 22% vs 16% (P = .06; October 10, 2018), and 25% vs 14% (P < .001; September 10, 2019).","[{'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'University of California San Francisco Helen Diller Family Comprehensive Cancer Center.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Cardoso', 'Affiliation': 'Champalimaud Clinical Center/Champalimaud Foundation, Breast Unit, Lisbon, Portugal.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cortés', 'Affiliation': 'IOB Institute of Oncology, Quironsalud Group, Madrid and Barcelona, Spain.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Curigliano', 'Affiliation': 'European Institute of Oncology, IRCCS, Division of Early Drug Development, University of Milano, Milan, Italy.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Musolino', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Medical Oncology and Breast Unit, University Hospital of Parma, Parma, Italy.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Pegram', 'Affiliation': 'Stanford Comprehensive Cancer Institute, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Gail S', 'Initials': 'GS', 'LastName': 'Wright', 'Affiliation': 'Florida Cancer Specialists & Research Institute, New Port Richey.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Saura', 'Affiliation': ""Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), Medical Oncology Service, Barcelona, Spain.""}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Escrivá-de-Romaní', 'Affiliation': ""Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), Medical Oncology Service, Barcelona, Spain.""}, {'ForeName': 'Michelino', 'Initials': 'M', 'LastName': 'De Laurentiis', 'Affiliation': 'Department of Breast and Thoracic Oncology, Istituto Nazionale Tumori ""Fondazione Pascale"", Naples, Italy.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Levy', 'Affiliation': 'Centre François Baclesse, Institut Normand du Sein, Caen, France.'}, {'ForeName': 'Ursa', 'Initials': 'U', 'LastName': 'Brown-Glaberman', 'Affiliation': 'Division of Hematology/Oncology, University of New Mexico Comprehensive Cancer Center, Albuquerque.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Ferrero', 'Affiliation': ""Centre Antoine Lacassagne, Department of Medical Oncology, University Côte d'Azur, Nice, France.""}, {'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'de Boer', 'Affiliation': 'Maastricht University Medical Center, Division of Medical Oncology, Department of Internal Medicine, GROW-School of Oncology and Developmental Biology, Maastricht, the Netherlands.'}, {'ForeName': 'Sung-Bae', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': 'Department of Oncology, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Katarína', 'Initials': 'K', 'LastName': 'Petráková', 'Affiliation': 'Department of Comprehensive Cancer Care, Masaryk Memorial Cancer Institute, Brno, Czech Republic.'}, {'ForeName': 'Denise A', 'Initials': 'DA', 'LastName': 'Yardley', 'Affiliation': 'Sarah Cannon Research Institute, Tennessee Oncology PLLC, Nashville.'}, {'ForeName': 'Orit', 'Initials': 'O', 'LastName': 'Freedman', 'Affiliation': 'RS McLaughlin Durham Regional Cancer Centre, Lakeridge Health, Oshawa, Ontario, Canada.'}, {'ForeName': 'Erik H', 'Initials': 'EH', 'LastName': 'Jakobsen', 'Affiliation': 'Department of Oncology, Vejle Hospital, Vejle, Denmark.'}, {'ForeName': 'Bella', 'Initials': 'B', 'LastName': 'Kaufman', 'Affiliation': 'Chaim Sheba Medical Center, Breast Oncology Institute, Ramat Gan, Israel.'}, {'ForeName': 'Rinat', 'Initials': 'R', 'LastName': 'Yerushalmi', 'Affiliation': 'Davidoff Cancer Center, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'Erlangen University Hospital, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, Department of Gynecology and Obstetrics, Friedrich Alexander University of Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Nordstrom', 'Affiliation': 'MacroGenics, Inc, Rockville, Maryland.'}, {'ForeName': 'Ezio', 'Initials': 'E', 'LastName': 'Bonvini', 'Affiliation': 'MacroGenics, Inc, Rockville, Maryland.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Koenig', 'Affiliation': 'MacroGenics, Inc, Rockville, Maryland.'}, {'ForeName': 'Sutton', 'Initials': 'S', 'LastName': 'Edlich', 'Affiliation': 'MacroGenics, Inc, Rockville, Maryland.'}, {'ForeName': 'Shengyan', 'Initials': 'S', 'LastName': 'Hong', 'Affiliation': 'MacroGenics, Inc, Rockville, Maryland.'}, {'ForeName': 'Edwin P', 'Initials': 'EP', 'LastName': 'Rock', 'Affiliation': 'MacroGenics, Inc, Rockville, Maryland.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Gradishar', 'Affiliation': 'Division of Hematology/Oncology, Northwestern University, Chicago, Illinois.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA oncology,['10.1001/jamaoncol.2020.7932'] 1972,33494781,"Efficacy of different spinal cord stimulation paradigms for the treatment of chronic neuropathic pain (PARS-trial): study protocol for a double-blinded, randomized, and placebo-controlled crossover trial.","BACKGROUND Spinal cord stimulation (SCS) is an effective method to treat neuropathic pain; however, it is challenging to compare different stimulation modalities in an individual patient, and thus, it is largely unknown which of the many available SCS modalities is most effective. Specifically, electrodes leading out through the skin would have to be consecutively connected to different, incompatible SCS devices and be tested over a time period of several weeks or even months. The risk of wound infections for such a study would be unacceptably high and blinding of the trial difficult. The PARS-trial seizes the capacity of a new type of wireless SCS device, which enables a blinded and systematic intra-patient comparison of different SCS modalities over extended time periods and without increasing wound infection rates. METHODS The PARS-trial is designed as a double-blinded, randomized, and placebo-controlled multi-center crossover study. It will compare the clinical effectiveness of the three most relevant SCS paradigms in individual patients. The trial will recruit 60 patients suffering from intractable neuropathic pain of the lower extremities, who have been considered for SCS therapy and were already implanted with a wireless SCS device prior to study participation. Over a time period of 35 days, patients will be treated consecutively with three different SCS paradigms (""burst,"" ""1 kHz,"" and ""1.499 kHz"") and placebo stimulation. Each SCS paradigm will be applied for 5 days with a washout period of 70 h between stimulation cycles. The primary endpoint of the study is the level of pain self-assessment on the visual analogue scale after 5 days of SCS. Secondary, exploratory endpoints include self-assessment of pain quality (as determined by painDETECT questionnaire), quality of life (as determined by Quality of Life EQ-5D-5L questionnaire), anxiety perception (as determined by the Hospital Anxiety and Depression Scale), and physical restriction (as determined by the Oswestry Disability Index). DISCUSSION Combining paresthesia-free SCS modalities with wireless SCS offers a unique opportunity for a blinded and systematic comparison of different SCS modalities in individual patients. This trial will advance our understanding of the clinical effectiveness of the most relevant SCS paradigms. TRIAL REGISTRATION German Clinical Trials Register, DRKS00018929 . Registered on 14 January 2020.",2021,"quality of life (as determined by Quality of Life EQ-5D-5L questionnaire), anxiety perception (as determined by the Hospital Anxiety and Depression Scale), and physical restriction (as determined by the Oswestry Disability Index). ","['individual patients', '60 patients suffering from intractable neuropathic pain of the lower extremities, who have been considered for SCS therapy and were already implanted with a wireless SCS device prior to study participation']","['spinal cord stimulation paradigms', 'placebo stimulation', 'placebo', 'Spinal cord stimulation (SCS']","['quality of life (as determined by Quality of Life EQ-5D-5L questionnaire), anxiety perception (as determined by the Hospital Anxiety and Depression Scale), and physical restriction (as determined by the Oswestry Disability Index', 'self-assessment of pain quality (as determined by painDETECT questionnaire', 'chronic neuropathic pain', 'level of pain self-assessment on the visual analogue scale']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C4544057', 'cui_str': 'Chronic neuropathic pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",60.0,0.209828,"quality of life (as determined by Quality of Life EQ-5D-5L questionnaire), anxiety perception (as determined by the Hospital Anxiety and Depression Scale), and physical restriction (as determined by the Oswestry Disability Index). ","[{'ForeName': 'Rezvan', 'Initials': 'R', 'LastName': 'Ahmadi', 'Affiliation': 'Department of Neurosurgery, University Hospital Heidelberg, INF 400, 69120, Heidelberg, Germany. rezvan.ahmadi@med.uni-heidelberg.de.'}, {'ForeName': 'Benito', 'Initials': 'B', 'LastName': 'Campos', 'Affiliation': 'Department of Neurosurgery, University Hospital Heidelberg, INF 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Mohammad Mehdi', 'Initials': 'MM', 'LastName': 'Hajiabadi', 'Affiliation': 'Department of Neurosurgery, University Hospital Heidelberg, INF 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Colette', 'Initials': 'C', 'LastName': 'Doerr-Harim', 'Affiliation': 'The Study Center of the German Surgical Society (SDGC), University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Solveig', 'Initials': 'S', 'LastName': 'Tenckhoff', 'Affiliation': 'The Study Center of the German Surgical Society (SDGC), University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Rasche', 'Affiliation': 'Department of Neurosurgery, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Unterberg', 'Affiliation': 'Department of Neurosurgery, University Hospital Heidelberg, INF 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Vesper', 'Affiliation': 'Department of Functional Neurosurgery and Stereotaxy, Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Bruckner', 'Affiliation': 'Institute of Medical Bioinformatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Tronnier', 'Affiliation': 'Department of Neurosurgery, University of Lübeck, Lübeck, Germany.'}]",Trials,['10.1186/s13063-020-05013-7'] 1973,33501671,Safety and efficacy of nusinersen in spinal muscular atrophy: The EMBRACE study.,"INTRODUCTION The EMBRACE study (Clinical Trials No. NCT02462759) evaluated nusinersen in infants/children with infantile- or later-onset spinal muscular atrophy (SMA) who were ineligible for the ENDEAR and CHERISH studies. METHODS Participants were randomized to intrathecal nusinersen (12-mg scaled equivalent dose; n = 14) or sham procedure (n = 7) in part 1 (~14 months) and subsequently received open-label nusinersen for ~24 months in part 2 of the study. RESULTS Part 1 was stopped early after the demonstration of motor function benefit with nusinersen in ENDEAR. There were no nusinersen-related adverse events (AEs) and no study discontinuations due to nusinersen-related AEs. The most common AEs included pyrexia, cough, pneumonia, and upper respiratory tract infections. Motor milestone responder rates were higher in those receiving nusinersen at last available assessment (93%) than in those receiving sham procedure in part 1 (29%) or transitioned from sham to nusinersen in part 2 (83%). This functional improvement was observed despite the small sample size and shortened part 1 trial duration that undermined the power of the study to demonstrate such treatment effects at a significant level. DISCUSSION Nusinersen demonstrated a favorable long-term benefit-risk profile in this broad population of individuals with infantile- or later-onset SMA.",2021,There were no nusinersen-related adverse events (AEs) and no study discontinuations due to nusinersen-related AEs.,"['spinal muscular atrophy', 'infants/children with infantile- or later-onset spinal muscular atrophy (SMA) who were ineligible for the ENDEAR and CHERISH studies', 'Participants']","['intrathecal nusinersen (12-mg scaled equivalent dose; n\xa0=\xa014) or sham procedure (n\xa0=\xa07) in Part 1 (~14 months) and subsequently received open-label nusinersen', 'nusinersen']","['Safety and efficacy', 'pyrexia, cough, pneumonia, and upper respiratory tract infections', 'Motor milestone responder rates']","[{'cui': 'C0026847', 'cui_str': 'Spinal muscular atrophy'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C4301236', 'cui_str': 'nusinersen'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}]",,0.0573774,There were no nusinersen-related adverse events (AEs) and no study discontinuations due to nusinersen-related AEs.,"[{'ForeName': 'Gyula', 'Initials': 'G', 'LastName': 'Acsadi', 'Affiliation': ""Division of Pediatric Neurology, Connecticut Children's Medical Center, University of Connecticut School of Medicine, Farmington, Connecticut, USA.""}, {'ForeName': 'Thomas O', 'Initials': 'TO', 'LastName': 'Crawford', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Müller-Felber', 'Affiliation': 'Department of Neuropediatrics, Developmental Neurology and Social Pediatrics, LMU Campus Innenstadt, University of Munich, Munich, Germany.'}, {'ForeName': 'Perry B', 'Initials': 'PB', 'LastName': 'Shieh', 'Affiliation': 'Department of Neurology, UCLA Clinical and Translational Research Center, Los Angeles, California, USA.'}, {'ForeName': 'Randal', 'Initials': 'R', 'LastName': 'Richardson', 'Affiliation': ""Pediatric Neurology, Gillette Children's Specialty Healthcare, St Paul, Minnesota, USA.""}, {'ForeName': 'Niranjana', 'Initials': 'N', 'LastName': 'Natarajan', 'Affiliation': ""Department of Neurology, Seattle Children's Research Institute, Seattle, Washington, USA.""}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Castro', 'Affiliation': 'Department of Pediatrics, Neurology and Neurotherapeutics, UT Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Ramirez-Schrempp', 'Affiliation': 'Biogen, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Gambino', 'Affiliation': 'Biogen, Maidenhead, UK.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Sun', 'Affiliation': 'Biogen, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Wildon', 'Initials': 'W', 'LastName': 'Farwell', 'Affiliation': 'Biogen, Cambridge, Massachusetts, USA.'}]",Muscle & nerve,['10.1002/mus.27187'] 1974,33499519,Sleep Deprivation and Sleep-Onset Insomnia are Associated with Blunted Physiological Reactivity to Stressors.,"INTRODUCTION Military operations often involve intense exposure to stressors combined with acute sleep deprivation, while military personnel also experience high prevalence of chronic sleep deficiency from insomnia and other sleep disorders. However, the impact of acute and chronic sleep deficiency on physiologic stressor responses is poorly understood. In a controlled laboratory study with normal sleepers and individuals with chronic sleep-onset insomnia, we measured responses to an acute stressor administered in a sleep deprivation condition or a control condition. METHODS Twenty-two adults (aged 22-40 years; 16 females)-11 healthy normal sleepers and 11 individuals with sleep-onset insomnia-completed a 5-day (4-night) in-laboratory study. After an adaptation day and a baseline day, subjects were assigned to a 38-hour total sleep deprivation (TSD) condition or a control condition; the study ended with a recovery day. At 8:00 PM after 36 hours awake in the sleep deprivation condition or 12 hours awake in the control condition, subjects underwent a Maastricht Acute Stress Test (MAST). Salivary cortisol was measured immediately before the MAST at 8:00 PM, every 15 minutes after the MAST from 8:15 PM until 9:15 PM, and 30 minutes later at 9:45 PM. Baseline salivary cortisol was collected in the evening of the baseline day. Additionally, before and immediately upon completion of the MAST, self-report ratings of affect and pain were collected. RESULTS The MAST elicited a stressor response in both normal sleepers and individuals with sleep-onset insomnia, regardless of the condition, as evidenced by increases in negative affect and pain ratings. Relative to baseline, cortisol levels increased immediately following the MAST, peaked 30 minutes later, and then gradually returned to pre-MAST levels. At the cortisol peak, there was a significant difference across groups and conditions, reflecting a pronounced blunting of the cortisol response in the normal sleepers in the TSD condition and the sleep-onset insomnia group in both the TSD and control conditions. CONCLUSIONS Blunted stressor reactivity as a result of sleep deficiency, whether acute or chronic, may reflect reduced resiliency attributable to allostatic load and may put warfighters at increased risk in high-stakes, rapid response scenarios.",2021,"At the cortisol peak, there was a significant difference across groups and conditions, reflecting a pronounced blunting of the cortisol response in the normal sleepers in the TSD condition and the sleep-onset insomnia group in both the TSD and control conditions. ","['Twenty-two adults (aged 22-40 years; 16 females)-11 healthy normal sleepers and 11 individuals with sleep-onset insomnia-completed a 5-day (4-night) in-laboratory study', 'normal sleepers and individuals with chronic sleep-onset insomnia']","['Maastricht Acute Stress Test (MAST', 'acute stressor administered in a sleep deprivation condition or a control condition', '38-hour total sleep deprivation (TSD) condition or a control condition']","['Salivary cortisol', 'Sleep Deprivation and Sleep-Onset Insomnia', 'negative affect and pain ratings', 'cortisol levels', 'MAST, self-report ratings of affect and pain', 'Baseline salivary cortisol', 'cortisol response']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",22.0,0.0477768,"At the cortisol peak, there was a significant difference across groups and conditions, reflecting a pronounced blunting of the cortisol response in the normal sleepers in the TSD condition and the sleep-onset insomnia group in both the TSD and control conditions. ","[{'ForeName': 'Devon A', 'Initials': 'DA', 'LastName': 'Hansen', 'Affiliation': 'Sleep and Performance Research Center and Elson S. Floyd College of Medicine, Washington State University, Spokane, WA 99202, USA.'}, {'ForeName': 'Brieann C', 'Initials': 'BC', 'LastName': 'Satterfield', 'Affiliation': 'Sleep and Performance Research Center and Elson S. Floyd College of Medicine, Washington State University, Spokane, WA 99202, USA.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Layton', 'Affiliation': 'Sleep and Performance Research Center and Elson S. Floyd College of Medicine, Washington State University, Spokane, WA 99202, USA.'}, {'ForeName': 'Hans P A', 'Initials': 'HPA', 'LastName': 'Van Dongen', 'Affiliation': 'Sleep and Performance Research Center and Elson S. Floyd College of Medicine, Washington State University, Spokane, WA 99202, USA.'}]",Military medicine,['10.1093/milmed/usaa464'] 1975,33499510,Developing and Testing a Web-Based Provider Training for Cognitive Behavioral Therapy of Insomnia.,"INTRODUCTION Chronic insomnia is a common and debilitating disease that increases risk for significant morbidity and workplace difficulties. Cognitive behavioral therapy for insomnia (CBT-I) is the first-line treatment, but there is a critical lack of behavioral health providers trained in CBT-I because, in part, of a bottleneck in training availability and costs. The current project developed and evaluated a web-based provider training course for CBT-I: CBTIweb.org. MATERIALS AND METHODS Subject matter experts developed the content for CBTIweb.org. Then, trainees completed alpha testing (n = 24) and focus groups, and the site was improved. Next, licensed behavioral health providers and trainees completed beta testing (n = 41) and the site underwent another round of modifications. Finally, to compare CBTIweb.org to an in-person workshop, licensed behavioral health providers were randomly assigned to CBTIweb.org (n = 21) or an in-person workshop (n = 23). All participants were CBT-I naïve and completed the following assessments: Computer System Usability Questionnaire, Website Usability Satisfaction Questionnaire, Website Content Satisfaction Questionnaire, and Continuing Education knowledge acquisition questionnaires. RESULTS Alpha and beta testers of CBTIweb.org reported high levels of usability and satisfaction with the site and showed significant within-group knowledge acquisition. In the pilot comparison study, linear fixed-effects modeling on the pre-/postquestionnaires revealed a significant main effect for time, indicating a significant increase in knowledge acquisition from 69% correct at baseline to 92% correct at posttraining collapsed across in-person and CBTIweb.org groups. The interaction effect of Time by Condition was nonsignificant, indicating equivalence in knowledge gains across both groups. CONCLUSION CBTIweb.org appears to be an engaging, interactive, and concise provider training that can be easily navigated by its users and produce significant knowledge gains that are equivalent to traditional in-person workshops. CBTIweb.org will allow for worldwide dissemination of CBT-I to any English-speaking behavioral health providers. Future research will work on translating this training to other languages and extending this web-based platform to the treatment of other sleep disorders (e.g., nightmares) and populations (e.g., pediatric populations with insomnia).",2021,"The interaction effect of Time by Condition was nonsignificant, indicating equivalence in knowledge gains across both groups. ",['Subject matter experts developed the content for CBTIweb.org'],"['Cognitive behavioral therapy', 'CBTIweb.org']","['Computer System Usability Questionnaire, Website Usability Satisfaction Questionnaire, Website Content Satisfaction Questionnaire, and Continuing Education knowledge acquisition questionnaires', 'usability and satisfaction', 'knowledge acquisition']","[{'cui': 'C0423896', 'cui_str': 'Feeling content'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0009612', 'cui_str': 'Computer Systems'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0013626', 'cui_str': 'Continuing Education'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",,0.0319456,"The interaction effect of Time by Condition was nonsignificant, indicating equivalence in knowledge gains across both groups. ","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Taylor', 'Affiliation': 'Department of Psychology, University of North Texas, Denton, TX 76203, USA.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Dietch', 'Affiliation': 'Department of Psychology, University of North Texas, Denton, TX 76203, USA.'}, {'ForeName': 'Kristi', 'Initials': 'K', 'LastName': 'Pruiksma', 'Affiliation': 'Department of Psychiatry, UT Health San Antonio, San Antonio, TX 78229, USA.'}, {'ForeName': 'Casey D', 'Initials': 'CD', 'LastName': 'Calhoun', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC 29425, USA.'}, {'ForeName': 'Melissa E', 'Initials': 'ME', 'LastName': 'Milanak', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC 29425, USA.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Wardle-Pinkston', 'Affiliation': 'Department of Psychology, University of North Texas, Denton, TX 76203, USA.'}, {'ForeName': 'Alyssa A', 'Initials': 'AA', 'LastName': 'Rheingold', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC 29425, USA.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Ruggiero', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC 29425, USA.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Bunnell', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC 29425, USA.'}, {'ForeName': 'Allison K', 'Initials': 'AK', 'LastName': 'Wilkerson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC 29425, USA.'}]",Military medicine,['10.1093/milmed/usaa359'] 1976,31919134,Analysis of Pre- and Posttreatment Tissues from the SWOG S0800 Trial Reveals an Effect of Neoadjuvant Chemotherapy on the Breast Cancer Genome.,"PURPOSE We performed whole-exome sequencing (WES) of pre- and posttreatment cancer tissues to assess the somatic mutation landscape of tumors before and after neoadjuvant taxane and anthracycline chemotherapy with or without bevacizumab. EXPERIMENTAL DESIGN Twenty-nine pretreatment biopsies from the SWOG S0800 trial were subjected to WES to identify mutational patterns associated with response to neoadjuvant chemotherapy. Nine matching samples with residual cancer after therapy were also analyzed to assess changes in mutational patterns in response to therapy. RESULTS In pretreatment samples, a higher proportion of mutation signature 3, a BRCA-mediated DNA repair deficiency mutational signature, was associated with higher rate of pathologic complete response (pCR; median signature weight 24%, range 0%-38% in pCR vs. median weight 0%, range 0%-19% in residual disease, Wilcoxon rank sum, Bonferroni P = 0.007). We found no biological pathway level mutations associated with pCR or enriched in posttreatment samples. We observed statistically significant enrichment of high functional impact mutations in the ""E2F targets"" and ""G 2 -M checkpoint"" pathways in residual cancer samples implicating these pathways in resistance to therapy and a significant depletion of mutations in the ""myogenesis pathway"" suggesting the cells harboring these variants were effectively eradicated by therapy. CONCLUSIONS These results suggest that genomic disturbances in BRCA-related DNA repair mechanisms, reflected by a dominant mutational signature 3, confer increased chemotherapy sensitivity. Cancers that survive neoadjuvant chemotherapy frequently have alterations in cell-cycle-regulating genes but different genes of the same pathways are affected in different patients.",2020,"In pretreatment samples, a higher proportion of mutation signature 3, a BRCA-mediated DNA repair deficiency mutational signature, was associated with higher rate of pathologic complete response (pCR; median signature weight 24%, range 0%-38% in pCR vs. median weight 0%, range 0%-19% in residual disease, Wilcoxon rank sum, Bonferroni P =",['Twenty-nine pretreatment biopsies from the SWOG S0800 trial'],"['neoadjuvant taxane and anthracycline chemotherapy with or without bevacizumab', 'neoadjuvant chemotherapy', 'Neoadjuvant Chemotherapy']",['rate of pathologic complete response'],"[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",,0.056446,"In pretreatment samples, a higher proportion of mutation signature 3, a BRCA-mediated DNA repair deficiency mutational signature, was associated with higher rate of pathologic complete response (pCR; median signature weight 24%, range 0%-38% in pCR vs. median weight 0%, range 0%-19% in residual disease, Wilcoxon rank sum, Bonferroni P =","[{'ForeName': 'Ryan L', 'Initials': 'RL', 'LastName': 'Powles', 'Affiliation': 'Breast Medical Oncology, Yale Cancer Center, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Vikram B', 'Initials': 'VB', 'LastName': 'Wali', 'Affiliation': 'Breast Medical Oncology, Yale Cancer Center, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Xiaotong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Breast Medical Oncology, Yale Cancer Center, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Barlow', 'Affiliation': 'SWOG Statistical Center, Seattle, Washington.'}, {'ForeName': 'Zeina', 'Initials': 'Z', 'LastName': 'Nahleh', 'Affiliation': 'Cleveland Clinic Florida, Maroone Cancer Center, Weston, Florida.'}, {'ForeName': 'Alastair M', 'Initials': 'AM', 'LastName': 'Thompson', 'Affiliation': 'Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Andrew K', 'Initials': 'AK', 'LastName': 'Godwin', 'Affiliation': 'University of Kansas, Kansas City, Kansas.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Hatzis', 'Affiliation': 'Breast Medical Oncology, Yale Cancer Center, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Lajos', 'Initials': 'L', 'LastName': 'Pusztai', 'Affiliation': 'Breast Medical Oncology, Yale Cancer Center, Yale School of Medicine, New Haven, Connecticut. lajos.pusztai@yale.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-2405'] 1977,33507592,"Effect of watercress extract supplementation on lipid profile and oxidative stress markers in overweight people with physical disability: A randomized, double-blind, and placebo-controlled trial.","Studies have demonstrated that diet rich in cruciferous vegetables of the Brassicaceae family can reduce the risk of cardiovascular diseases and oxidative stress levels. Nasturtium officinale (Brassicaceae), commonly known as watercress is a perennial dicotyledonous plant usually found close to water. Although previous investigations have demonstrated the beneficial effects of watercress on hypercholesterolemia in animal studies, until now no such studies have been conducted with humans, up to this time. This study aimed to investigate whether overweight individuals were able to improve or maintain their serum lipid and oxidative stress markers when given standardized extract of Nasturtium officinale (SENO) as a supplement. This was a randomized, double-blind, and placebo-controlled trial conducted over 5 weeks. Thirty-four overweight people with physical disabilities were selected randomly to participate in this study and then they were assigned randomly to two groups, one treated with 750 mg//kg/d of SENO and the other treated with 750 mg/kg/d of placebo. The results indicated that SENO caused a significant improvement in the levels of low-density lipoprotein cholesterol, creatinine, and lipid peroxidation. However, SENO did not cause a significant statistical change in total serum cholesterol, triacylglycerol, and high-density lipoprotein levels; catalase, superoxide dismutase, creatinine, alanine aminotransferase, aspartate aminotransferase, and urea parameters. The present data might provide supportive evidence that SENO did not cause any harm and positively affected low-density lipoprotein cholesterol profile and creatinine as well as lipid peroxidation levels in the participants. Nevertheless, further studies are suggested to clarify the results presented in this clinical trial.",2021,"However, SENO did not cause a significant statistical change in total serum cholesterol, triacylglycerol, and high-density lipoprotein levels; catalase, superoxide dismutase, creatinine, alanine aminotransferase, aspartate aminotransferase, and urea parameters.","['Thirty-four overweight people with physical disabilities', 'overweight individuals', 'overweight people with physical disability']","['SENO', 'placebo', 'watercress extract supplementation']","['lipid profile and oxidative stress markers', 'levels of low-density lipoprotein cholesterol, creatinine, and lipid peroxidation', 'lipid peroxidation levels', 'total serum cholesterol, triacylglycerol, and high-density lipoprotein levels; catalase, superoxide dismutase, creatinine, alanine aminotransferase, aspartate aminotransferase, and urea parameters']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}]","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0453151', 'cui_str': 'Watercress'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0023775', 'cui_str': 'Lipid peroxidation'}, {'cui': 'C1445957', 'cui_str': 'Serum total cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",34.0,0.447374,"However, SENO did not cause a significant statistical change in total serum cholesterol, triacylglycerol, and high-density lipoprotein levels; catalase, superoxide dismutase, creatinine, alanine aminotransferase, aspartate aminotransferase, and urea parameters.","[{'ForeName': 'Mirna', 'Initials': 'M', 'LastName': 'Clemente', 'Affiliation': 'Department of Pharmaceutical Science, Federal University of Parana (UFPR), Curitiba, Brazil.'}, {'ForeName': 'Marilis D', 'Initials': 'MD', 'LastName': 'Miguel', 'Affiliation': 'Department of Pharmaceutical Science, Federal University of Parana (UFPR), Curitiba, Brazil.'}, {'ForeName': 'Karina B', 'Initials': 'KB', 'LastName': 'Felipe', 'Affiliation': 'Department of Biochemistry, Federal University of Parana (UFPR), Curitiba, Brazil.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Gribner', 'Affiliation': 'Department of Pharmaceutical Science, Federal University of Parana (UFPR), Curitiba, Brazil.'}, {'ForeName': 'Paula F', 'Initials': 'PF', 'LastName': 'Moura', 'Affiliation': 'Department of Pharmaceutical Science, Federal University of Parana (UFPR), Curitiba, Brazil.'}, {'ForeName': 'Ana A R', 'Initials': 'AAR', 'LastName': 'Rigoni', 'Affiliation': 'Department of Pharmaceutical Science, Federal University of Parana (UFPR), Curitiba, Brazil.'}, {'ForeName': 'Eduardo B', 'Initials': 'EB', 'LastName': 'Parisotto', 'Affiliation': 'School of Pharmaceutical Sciences, Food and Nutrition Federal University of Mato Grosso do Sul (UFMS), Campo Grande, Brazil.'}, {'ForeName': 'Railson', 'Initials': 'R', 'LastName': 'Henneberg', 'Affiliation': 'Clinical Analysis Department, Federal University of Parana (UFPR), Curitiba, Brazil.'}, {'ForeName': 'Josiane de Fatima Gaspari', 'Initials': 'JFG', 'LastName': 'Dias', 'Affiliation': 'Department of Pharmaceutical Science, Federal University of Parana (UFPR), Curitiba, Brazil.'}, {'ForeName': 'Marina T', 'Initials': 'MT', 'LastName': 'Piltz', 'Affiliation': 'Department of Pharmaceutical Science, Federal University of Parana (UFPR), Curitiba, Brazil.'}, {'ForeName': 'Erick F', 'Initials': 'EF', 'LastName': 'Clemente', 'Affiliation': 'Department of Pharmaceutical Science, Federal University of Parana (UFPR), Curitiba, Brazil.'}, {'ForeName': 'Christian B', 'Initials': 'CB', 'LastName': 'Schonhofen', 'Affiliation': 'Department of Pharmaceutical Science, Federal University of Parana (UFPR), Curitiba, Brazil.'}, {'ForeName': 'João L S', 'Initials': 'JLS', 'LastName': 'Carvalho', 'Affiliation': 'Department of Pharmaceutical Science, Federal University of Parana (UFPR), Curitiba, Brazil.'}, {'ForeName': 'Luiz C', 'Initials': 'LC', 'LastName': 'Fernandes', 'Affiliation': 'Department of Physiology, Federal University of Parana (UFPR), Curitiba, Brazil.'}, {'ForeName': 'Obdúlio G', 'Initials': 'OG', 'LastName': 'Miguel', 'Affiliation': 'Department of Pharmaceutical Science, Federal University of Parana (UFPR), Curitiba, Brazil.'}]",Phytotherapy research : PTR,['10.1002/ptr.6979'] 1978,33512028,Effectiveness of a structured group intervention based on pain neuroscience education for patients with fibromyalgia in primary care: A multicentre randomized open-label controlled trial.,"BACKGROUND There has been increased interest in pain neuroscience education (PNE) as a therapeutic approach for the management of fibromyalgia (FM). METHODS A multicentre randomized, open-label, controlled trial was conducted to assess the effectiveness of a structured group intervention based on PNE in patients with FM. A total of 139 patients were included in the study and randomized to the intervention group (7 group sessions of education in neurobiology of pain) or to the control group (treatment as usual only). The primary outcome was the improvement of functional status and pain measured with the Fibromyalgia Impact Questionnaire (FIQ), and secondary outcomes were the reduction in the impact of pain and other symptoms (catastrophizing, anxiety and depression) and number of patients reaching no worse than moderate functional impairment (FIQ score <39). Differences between groups were calculated by linear mixed-effects (intention-to-treat approach) and mediational models through path analyses. RESULTS At 1 year, improvements in FIQ scores were higher in the intervention group with moderate or high effect size, and decreases of ≥20% in 69.1% of patients (20.9% in the control group) and of ≥50% in 39.7% (4.5% in the control group). Also, 52.9% of patients had a FIQ <39 points (13.4% in the control group). CONCLUSIONS In this sample of patients with FM, the improvement in quality of life and control of symptoms obtained by adding a PNE intervention showed promising results, equalling or surpassing previously reported outcomes. SIGNIFICANCE A structured group intervention based on pain neuroscience education for 1 year in patients with fibromyalgia was associated with significant amelioration of the impact of the disease on scores of the Fibromyalgia Impact Questionnaire, the Health Assessment Questionnaire, the Hospital Anxiety and Depression Scale, the Pain Catastrophizing Scale and the Polysymptomatic Distress Scale as compared with only treatment as usual. These findings are clinically relevant considering the challenges posed by fibromyalgia to clinicians and patients alike.",2021,"At 1 year, improvements in FIQ scores were higher in the intervention group with moderate or high effect size, and decreases of ≥ 20% in 69.1% of patients (20.9 % in the control group) and of ≥ 50% in 39.7% (4.5% in the control group).","['patients with fibromyalgia in primary care', 'patients with FM', 'A total of 139 patients']","['intervention group (7 group sessions of education in neurobiology of pain) or to the control group (treatment as usual only', 'structured group intervention based on pain neuroscience education']","['improvement of functional status and pain measured with the Fibromyalgia Impact Questionnaire (FIQ), and secondary outcomes were the reduction of the impact of pain and other symptoms (catastrophizing, anxiety, and depression) and number of patients reaching no worse than moderate functional impairment (FIQ score < 39', 'quality of life and control of symptoms', 'FIQ scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C5191072', 'cui_str': '139'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027817', 'cui_str': 'Neurobiology'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",139.0,0.155448,"At 1 year, improvements in FIQ scores were higher in the intervention group with moderate or high effect size, and decreases of ≥ 20% in 69.1% of patients (20.9 % in the control group) and of ≥ 50% in 39.7% (4.5% in the control group).","[{'ForeName': 'María Jesús', 'Initials': 'MJ', 'LastName': 'Barrenengoa-Cuadra', 'Affiliation': 'Primary Health Care Center Sáenz de Buruaga, Osakidetza Basque Health Service, OSI Bilbao-Basurto, Bilbao, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Muñoa-Capron-Manieux', 'Affiliation': 'Working Group on Fibromyalgia, Migraine and Chronic Pain, Osatzen Sociedad Vasca de Medicina Familiar y Comunitaria, Bilbao, Spain.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Fernández-Luco', 'Affiliation': 'Working Group on Fibromyalgia, Migraine and Chronic Pain, Osatzen Sociedad Vasca de Medicina Familiar y Comunitaria, Bilbao, Spain.'}, {'ForeName': 'Luis Ángel', 'Initials': 'LÁ', 'LastName': 'Angón-Puras', 'Affiliation': 'Working Group on Fibromyalgia, Migraine and Chronic Pain, Osatzen Sociedad Vasca de Medicina Familiar y Comunitaria, Bilbao, Spain.'}, {'ForeName': 'Ana J', 'Initials': 'AJ', 'LastName': 'Romón-Gómez', 'Affiliation': 'Working Group on Fibromyalgia, Migraine and Chronic Pain, Osatzen Sociedad Vasca de Medicina Familiar y Comunitaria, Bilbao, Spain.'}, {'ForeName': 'Maider', 'Initials': 'M', 'LastName': 'Azkuenaga', 'Affiliation': 'Working Group on Fibromyalgia, Migraine and Chronic Pain, Osatzen Sociedad Vasca de Medicina Familiar y Comunitaria, Bilbao, Spain.'}, {'ForeName': 'Amaia', 'Initials': 'A', 'LastName': 'Etxebarria', 'Affiliation': 'Working Group on Fibromyalgia, Migraine and Chronic Pain, Osatzen Sociedad Vasca de Medicina Familiar y Comunitaria, Bilbao, Spain.'}, {'ForeName': 'Gixane', 'Initials': 'G', 'LastName': 'Orrantia', 'Affiliation': 'Working Group on Fibromyalgia, Migraine and Chronic Pain, Osatzen Sociedad Vasca de Medicina Familiar y Comunitaria, Bilbao, Spain.'}, {'ForeName': 'Ainhoa', 'Initials': 'A', 'LastName': 'Pikaza', 'Affiliation': 'Working Group on Fibromyalgia, Migraine and Chronic Pain, Osatzen Sociedad Vasca de Medicina Familiar y Comunitaria, Bilbao, Spain.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Uribe-Etxebarria', 'Affiliation': 'Working Group on Fibromyalgia, Migraine and Chronic Pain, Osatzen Sociedad Vasca de Medicina Familiar y Comunitaria, Bilbao, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Zorrilla', 'Affiliation': 'Working Group on Fibromyalgia, Migraine and Chronic Pain, Osatzen Sociedad Vasca de Medicina Familiar y Comunitaria, Bilbao, Spain.'}, {'ForeName': 'Gorka', 'Initials': 'G', 'LastName': 'Larrinaga', 'Affiliation': 'Department of Nursing, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Leioa, Spain.'}, {'ForeName': 'Eunate', 'Initials': 'E', 'LastName': 'Arana-Arri', 'Affiliation': 'Biocruces Bizkaia Health Research Institute, Cruces University Hospital, Barakaldo, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Gracia-Ballarín', 'Affiliation': 'Working Group on Fibromyalgia, Migraine and Chronic Pain, Osatzen Sociedad Vasca de Medicina Familiar y Comunitaria, Bilbao, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of pain (London, England)",['10.1002/ejp.1738'] 1979,33511576,Dupilumab Maintains Long-Term Disease Control in Adults with Moderate-to-Severe Atopic Dermatitis as Measured by Well-Controlled Weeks: Results From the LIBERTY AD CHRONOS Clinical Trial.,,2021,,['Adults with Moderate-to-Severe Atopic Dermatitis'],[],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}]",[],[],,0.0630416,,"[{'ForeName': 'Jashin J', 'Initials': 'JJ', 'LastName': 'Wu', 'Affiliation': 'Dermatology Research and Education Foundation, Irvine, CA, USA. jashinwu@gmail.com.'}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Spelman', 'Affiliation': 'Veracity Clinical Research and Probity Medical Research, Brisbane, Australia.'}, {'ForeName': 'Jerry L', 'Initials': 'JL', 'LastName': 'Tan', 'Affiliation': 'Windsor Clinical Research, Windsor, ON, Canada.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Etoh', 'Affiliation': 'Tokyo Teishin Postal Services Agency Hospital, Tokyo, Japan.'}, {'ForeName': 'Haixin', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Shumel', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Ana B', 'Initials': 'AB', 'LastName': 'Rossi', 'Affiliation': 'Sanofi Genzyme, Cambridge, MA, USA.'}]",Dermatology and therapy,['10.1007/s13555-021-00487-y'] 1980,33511505,"The effect of self-practicing systematic clinical observations in a multiplayer, immersive, interactive virtual reality application versus physical equipment: a randomized controlled trial.","This study aimed to investigate whether group self-practice of systematic clinical observation using the airway, breathing, circulation, disability and exposure (ABCDE) approach in a multiplayer, immersive, interactive virtual reality (VR) application provided a non-inferior learning outcome compared to practicing with physical equipment in first-year medical and nursing students. The study was a non-inferior, parallel-group randomized controlled trial. After a 15-min introduction session on the ABCDE approach, all students were randomly allocated to practice ABCDE in groups of three for 20 min either in a fully immersive, interactive, multiplayer virtual reality application (the VR group) or with physical equipment (the TP group). The primary outcome was the number of students who documented all predefined observations in the correct order of the ABCDE approach on a practical test performed immediately after group practice. A total of 84% of all eligible students participated, with 146 students in the VR group and 143 in the TP group. On the primary outcome, 20% in the VR group and 21% in the TP group got everything correct (absolute difference 1% point, one-sided 95% confidence interval 1.0-8.8% points), showing non-inferiority of the virtual reality application. For other outcomes, the results were mostly similar between the groups. Group self-practice of the ABCDE approach in multiplayer, immersive, interactive virtual reality application was non-inferior to practice with physical equipment.",2021,"Group self-practice of the ABCDE approach in multiplayer, immersive, interactive virtual reality application was non-inferior to practice with physical equipment.","['practicing with physical equipment in first-year medical and nursing students', 'A total of 84% of all eligible students participated, with 146 students in the VR group and 143 in the TP group']","['fully immersive, interactive, multiplayer virtual reality application (the VR group) or with physical equipment', 'practice ABCDE']",['everything correct'],"[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517573', 'cui_str': '143'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}]","[{'cui': 'C0205202', 'cui_str': 'Corrected'}]",,0.0466555,"Group self-practice of the ABCDE approach in multiplayer, immersive, interactive virtual reality application was non-inferior to practice with physical equipment.","[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Berg', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science and Technology, 7491, Trondheim, Norway. helen.berg@ntnu.no.'}, {'ForeName': 'Aslak', 'Initials': 'A', 'LastName': 'Steinsbekk', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science and Technology, 7491, Trondheim, Norway.'}]",Advances in health sciences education : theory and practice,['10.1007/s10459-020-10019-6'] 1981,33509678,Optimal interruption time of dabigatran oral administration to ablation (O-A time) in patients with atrial fibrillation: Integrated analysis of 2 randomized controlled clinical trials.,"BACKGROUND RE-CIRCUIT (NCT02348723) and ABRIDGE-J (UMIN000013129) are recently published randomized clinical trials showing that anticoagulation therapy with dabigatran during the periprocedural period of catheter ablation (CA) for atrial fibrillation (AF) was associated with fewer complications. However, the dabigatran administration protocols were different (uninterrupted in RE-CIRCUIT and minimally interrupted in ABRIDGE-J). The aim of this present study was to clarify the optimal interruption time of dabigatran Oral administration to Ablation (O-A time). METHODS We conducted an integrated analysis of the 2 prospective trials. The endpoint of the study was the incidence of major bleeding events during and up to 8 weeks after CA across participants with different O-A times. RESULTS The 535 patients in the dabigatran groups of the 2 trials were divided into 3 groups based on their O-A times (<8 h, n = 258; 8-24 h, n = 191; >24 h, n = 86). Major bleeding events occurred in 5 patients (1.9%) in the <8 h group, and 3 (3.5%) in the >24 h group; however, no major bleeding events occurred in the 8-24 h group (3 group-comparison, p = 0.026). No thromboembolic complication was observed in any of the 3 O-A time groups. CONCLUSION In patients undergoing CA for AF using dabigatran as a periprocedural anticoagulant, an O-A time of 8-24 h was associated with no bleeding complications. These data suggest that an O-A time of 8-24 h may be an appropriate option, especially in a low thromboembolic-risk patient.",2021,"No thromboembolic complication was observed in any of the 3 O-A time groups. ","['patients with atrial fibrillation', '535 patients in the dabigatran groups of the 2 trials']","['dabigatran oral administration to ablation (O-A time', 'dabigatran Oral administration to Ablation (O-A time']","['thromboembolic complication', 'incidence of major bleeding events', 'bleeding complications', 'no major bleeding events', 'Major bleeding events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0001563', 'cui_str': 'Medication administration: oral'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",,0.0249155,"No thromboembolic complication was observed in any of the 3 O-A time groups. ","[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Kimata', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Nogami', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Hiro', 'Initials': 'H', 'LastName': 'Yamasaki', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Ohigashi', 'Affiliation': 'Department of Biostatistics, Tsukuba Clinical Research & Development Organization, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Gosho', 'Affiliation': 'Department of Biostatistics, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Miyako', 'Initials': 'M', 'LastName': 'Igarashi', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Sekiguchi', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Ieda', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Hugh', 'Initials': 'H', 'LastName': 'Calkins', 'Affiliation': 'Johns Hopkins Medical Institutions, Baltimore, MD, USA.'}, {'ForeName': 'Kazutaka', 'Initials': 'K', 'LastName': 'Aonuma', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan. Electronic address: kaonuma@md.tsukuba.ac.jp.'}]",Journal of cardiology,['10.1016/j.jjcc.2020.12.010'] 1982,33509035,Aerobic exercise improves hippocampal blood flow for hypertensive Apolipoprotein E4 carriers.,"Cerebrovascular dysfunction likely contributes causally to Alzheimer's disease (AD). The strongest genetic risk factor for late-onset AD, Apolipoprotein E4 ( APOE4 ), may act synergistically with vascular risk to cause dementia. Therefore, interventions that improve vascular health, such as exercise, may be particularly beneficial for APOE4 carriers. We assigned cognitively normal adults (65-87 years) to an aerobic exercise intervention or education only. Arterial spin labeling MRI measured hippocampal blood flow (HBF) before and after the 52-week intervention. We selected participants with hypertension at enrollment (n = 44). For APOE4 carriers, change in HBF (ΔHBF) was significantly ( p  = 0.006) higher for participants in the exercise intervention (4.09 mL/100g/min) than the control group (-2.08 mL/100g/min). There was no difference in ΔHBF between the control (-0.32 mL/100g/min) and exercise (-0.54 mL/100g/min) groups for non-carriers (p = 0.918). Additionally, a multiple regression showed an interaction between change in systolic blood pressure (ΔSBP) and APOE4 carrier status on ΔHBF ( p  = 0.035), with reductions in SBP increasing HBF for APOE4 carriers only. Aerobic exercise improved HBF for hypertensive APOE4 carriers only. Additionally, only APOE4 carriers exhibited an inverse relationship between ΔSBP and ΔHBF. This suggests exercise interventions, particularly those that lower SBP, may be beneficial for individuals at highest genetic risk of AD. ClinicalTrials.gov Identifier : NCT02000583 .",2021,"For APOE4 carriers, change in HBF (ΔHBF) was significantly ( p  = 0.006) higher for participants in the exercise intervention (4.09 mL/100g/min) than the control group (-2.08 mL/100g/min).","['cognitively normal adults (65-87\u2009years', 'hypertensive Apolipoprotein E4 carriers', 'participants with hypertension at enrollment (n\u2009=\u200944']","['Aerobic exercise', 'aerobic exercise intervention or education only']","['ΔHBF', 'hippocampal blood flow', 'systolic blood pressure (ΔSBP) and APOE4 carrier status on ΔHBF', 'HBF (ΔHBF', 'Arterial spin labeling MRI measured hippocampal blood flow (HBF']","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0052201', 'cui_str': 'Apolipoprotein E4'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0052201', 'cui_str': 'Apolipoprotein E4'}, {'cui': 'C0449439', 'cui_str': 'Carrier status'}, {'cui': 'C0015936', 'cui_str': 'Hemoglobin F'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0831955,"For APOE4 carriers, change in HBF (ΔHBF) was significantly ( p  = 0.006) higher for participants in the exercise intervention (4.09 mL/100g/min) than the control group (-2.08 mL/100g/min).","[{'ForeName': 'Carolyn S', 'Initials': 'CS', 'LastName': 'Kaufman', 'Affiliation': 'Department of Molecular & Integrative Physiology, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Robyn A', 'Initials': 'RA', 'LastName': 'Honea', 'Affiliation': ""University of Kansas Alzheimer's Disease Center, Fairway, KS, USA.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Pleen', 'Affiliation': ""University of Kansas Alzheimer's Disease Center, Fairway, KS, USA.""}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Lepping', 'Affiliation': 'Hoglund Biomedical Imaging Center, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Watts', 'Affiliation': 'Department of Psychology, University of Kansas, Lawrence, KS, USA.'}, {'ForeName': 'Jill K', 'Initials': 'JK', 'LastName': 'Morris', 'Affiliation': ""University of Kansas Alzheimer's Disease Center, Fairway, KS, USA.""}, {'ForeName': 'Sandra A', 'Initials': 'SA', 'LastName': 'Billinger', 'Affiliation': 'Department of Molecular & Integrative Physiology, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Burns', 'Affiliation': ""University of Kansas Alzheimer's Disease Center, Fairway, KS, USA.""}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Vidoni', 'Affiliation': ""University of Kansas Alzheimer's Disease Center, Fairway, KS, USA.""}]",Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism,['10.1177/0271678X21990342'] 1983,33470755,"The short-term effects of estradiol, raloxifene, and a phytoestrogen in women with perimenopausal depression.","OBJECTIVE We examined the short-term efficacies of three estrogen-like compounds under placebo-controlled conditions in women with perimenopause-related depression (PMD). METHODS Women with PMD were randomized in a double-blind parallel design to one of four treatments: transdermal 17-beta estradiol (TE) (100 mcg/d); oral raloxifene (60 mg/d); a proprietary phytoestrogen compound, Rimostil (1,000 mg twice/d); or placebo for 8 weeks. The main outcome measures were the Center for Epidemiology Studies Depression Scale, 17-item Hamilton Rating Scale for Depression (HRSD), and the Beck Depression Inventory completed at each clinic visit. Secondary outcomes included a visual analogue self-rating completed at each clinic visit, and daily self-ratings of hot flush severity. Cognitive tests were performed at pretreatment baseline and at the end of the trial. In the primary analysis, we obtained four repeated measures in each woman in the four treatment arms. Analyses were done with SAS Version 9.4 software (SAS Institute, Inc, Cary, NC), using PROC MIXED (for mixed models). All models included the following four explanatory variables, regardless of whether they were statistically significant: 1) treatment group (TE, raloxifene, Rimostil, placebo); 2) week (W2, W4, W6, W8); 3) treatment group-by-week interaction; and 4) baseline value of the measure being analyzed. The inclusion of additional variables was evaluated individually for each outcome measure. RESULTS Sixty-six women were randomized into the trial, four women dropped out of the trial, and 62 women were included in the final data analysis. No effect of treatment group was observed in either the Center for Epidemiology Studies Depression Scale (P = 0.34) or Beck Depression Inventory (P = 0.27) scores; however, there was a difference in HRSD scores between treatment groups (P = 0.0037) that pair-wise comparisons of the combined weekly scores in each treatment demonstrated TE's beneficial effects on HRSD scores compared with Rimostil (P = 0.0005), and less consistently with placebo (P = 0.099). The average (SD) of the baseline scores for each treatment group on the HRSD was as follows: TE-15.3 (4.5), raloxifene-16.0 (3.7), Rimostil-14.0 (2.7), and placebo-15.2 (3.0). Whereas the HRSD scores after 8 weeks of treatment (least-square means) were TE-5.2(1.1), raloxifene-5.8(1.2), Rimostil-11.2(1.4), and placebo-7.8(1.1). No differences were observed between raloxifene and either TE or placebo in any scale score. HRSD scores in women assigned to TE were improved compared with those on Rimostil during weeks 6 and 8 (P values = 0.0008, 0.0011, respectively). Cognitive testing at week 8 showed that none of the three active treatment groups performed better than placebo. CONCLUSIONS This study did not identify significant therapeutic benefits of TE, Rimostil, or raloxifene compared with placebo in PMD. However, improvements in depression ratings were observed between TE compared with Rimostil. Thus, our findings do not support the role of ERbeta compounds in the treatment of PMD (and indeed could suggest a more important role of ERalpha).",2021,"No effect of treatment group was observed in either the Center for Epidemiology Studies Depression Scale (P = 0.34) or Beck Depression Inventory (P = 0.27) scores; however, there was a difference in HRSD scores between treatment groups (P = 0.0037) that pair-wise comparisons of the combined weekly scores in each treatment demonstrated TE's beneficial effects on HRSD scores compared with Rimostil (P = 0.0005), and less consistently with placebo (P = 0.099).","['women with perimenopause-related depression (PMD', 'women with perimenopausal depression', 'Women with PMD', 'Sixty-six women were randomized into the trial, four women dropped out of the trial, and 62 women were included in the final data analysis']","['raloxifene', 'proprietary phytoestrogen compound, Rimostil', 'placebo', 'estrogen-like compounds under placebo', 'raloxifene, Rimostil, placebo', 'TE or placebo', 'transdermal 17-beta estradiol (TE', 'TE, Rimostil, or raloxifene', 'estradiol, raloxifene', 'raloxifene-16.0']","['depression ratings', 'Beck Depression Inventory', 'HRSD scores', 'Epidemiology Studies Depression Scale', 'Cognitive testing', 'Center for Epidemiology Studies Depression Scale, 17-item Hamilton Rating Scale for Depression (HRSD), and the Beck Depression Inventory', 'visual analogue self-rating completed at each clinic visit, and daily self-ratings of hot flush severity']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0993589', 'cui_str': 'Perimenopause'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3839366', 'cui_str': 'Perimenopausal state'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0244404', 'cui_str': 'Raloxifene'}, {'cui': 'C0071011', 'cui_str': 'Phytoestrogen'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",4.0,0.400134,"No effect of treatment group was observed in either the Center for Epidemiology Studies Depression Scale (P = 0.34) or Beck Depression Inventory (P = 0.27) scores; however, there was a difference in HRSD scores between treatment groups (P = 0.0037) that pair-wise comparisons of the combined weekly scores in each treatment demonstrated TE's beneficial effects on HRSD scores compared with Rimostil (P = 0.0005), and less consistently with placebo (P = 0.099).","[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Schmidt', 'Affiliation': 'Section on Behavioral Endocrinology, National Institute of Mental Health, NIH, DHHS, Bethesda, MD.'}, {'ForeName': 'Shau-Ming', 'Initials': 'SM', 'LastName': 'Wei', 'Affiliation': 'Section on Behavioral Endocrinology, National Institute of Mental Health, NIH, DHHS, Bethesda, MD.'}, {'ForeName': 'Pedro E', 'Initials': 'PE', 'LastName': 'Martinez', 'Affiliation': 'Section on Behavioral Endocrinology, National Institute of Mental Health, NIH, DHHS, Bethesda, MD.'}, {'ForeName': 'Rivka R Ben', 'Initials': 'RRB', 'LastName': 'Dor', 'Affiliation': 'Section on Behavioral Endocrinology, National Institute of Mental Health, NIH, DHHS, Bethesda, MD.'}, {'ForeName': 'Gioia M', 'Initials': 'GM', 'LastName': 'Guerrieri', 'Affiliation': 'Section on Behavioral Endocrinology, National Institute of Mental Health, NIH, DHHS, Bethesda, MD.'}, {'ForeName': 'Paula P', 'Initials': 'PP', 'LastName': 'Palladino', 'Affiliation': 'Section on Behavioral Endocrinology, National Institute of Mental Health, NIH, DHHS, Bethesda, MD.'}, {'ForeName': 'Veronica L', 'Initials': 'VL', 'LastName': 'Harsh', 'Affiliation': 'Section on Behavioral Endocrinology, National Institute of Mental Health, NIH, DHHS, Bethesda, MD.'}, {'ForeName': 'Howard J', 'Initials': 'HJ', 'LastName': 'Li', 'Affiliation': 'Section on Behavioral Endocrinology, National Institute of Mental Health, NIH, DHHS, Bethesda, MD.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Wakim', 'Affiliation': 'Biostatistics and Clinical Epidemiology Service, Clinical Center, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Lynnette K', 'Initials': 'LK', 'LastName': 'Nieman', 'Affiliation': 'Intramural Research Program on Reproductive and Adult Endocrinology, The Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, DHHS, Bethesda, MD.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Rubinow', 'Affiliation': 'Department of Psychiatry, University of North Carolina, Chapel Hill, NC.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001724'] 1984,33470751,Integration of eHealth Into Pediatric Inflammatory Bowel Disease Care is Safe: 3 Years of Follow-up of Daily Care.,"OBJECTIVES The aim of the study was to evaluate integration of an eHealth solution, www.young.constant-care.com, into daily care (I-eHealth). METHODS The I-eHealth solution was offered to inflammatory bowel disease (IBD) patients ages 10 to 17 years old in nonbiological treatment. The application was used monthly and in case of flare-ups. Blood and fecal calprotectin (FC) were tested every 3 months and during flare-ups. A total inflammation score (based on symptoms and FC) was visualized for the patient in a traffic light curve. An IBD nurse followed up on the registrations every 2 weeks. Patients had 1 yearly planned visit at the hospital. On-demand visits were arranged depending on the total inflammation. I-eHealth results were compared with data from a previous randomized clinical trial (RCT)-eHealth study (the control group of which had 4 planned annual visits). RESULTS Thirty-six IBD patients were followed by I-eHealth, mean age 14.7 years (SD 7.75). The median (interquartile range [IQR]) duration of using I-eHealth was 1.9 years (0.29-2.51), equal to 66.11 patient-years, compared with 40.45 in the RCT-eHealth group and 46.49 in the RCT-control group. On-demand visits per patient-year did not differ between the groups: 1.13 (I-eHealth), 1.16 (RCT-eHealth), and 0.84 (RCT-control) (P = 0.84/0.85). Hospitalizations and acute outpatient visits per patient-year did not differ between the groups: 0.11 and 0.11 (I-eHealth), 0.05 and 0.02 (RCT-eHealth), 0.11 and 0.11 (RCT-control) (P = 0.17/0.81 and 0.12/0.81). Time to first escalation of medication, and time to first on-demand visit, did not differ between the I-eHealth group and data from the clinical trial (Log rank: P = 0.25 and P = 0.61). CONCLUSIONS I-eHealth is comparably with results from eHealth under RCT supervision.",2021,"Hospitalizations and acute outpatient visits per patient year did not differ between the groups: 0.11 and 0.11 (I-eHealth), 0.05 and 0.02 (RCT-eHealth), 0.11 and 0.11 (RCT-control) (p = 0.17/0.81 and 0.12/0.81).","['IBD patients aged 10-17\u200ayears old in non-biological treatment', '36 IBD patients were followed by I-eHealth, mean age 14.7 (SD 7.75', 'Patients had one yearly planned visit at the hospital']",[],"['median (IQR) duration of using I-eHealth', 'total inflammation score', 'Blood and fecal calprotectin (FC', 'Time to first escalation of medication, and time to first on-demand visit', 'Hospitalizations and acute outpatient visits per patient year']","[{'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0445097', 'cui_str': 'Non-biological'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",[],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}]",36.0,0.0350424,"Hospitalizations and acute outpatient visits per patient year did not differ between the groups: 0.11 and 0.11 (I-eHealth), 0.05 and 0.02 (RCT-eHealth), 0.11 and 0.11 (RCT-control) (p = 0.17/0.81 and 0.12/0.81).","[{'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Carlsen', 'Affiliation': 'Department of Pediatrics, Copenhagen University Hospital, Hvidovre.'}, {'ForeName': 'Nicoline Willum', 'Initials': 'NW', 'LastName': 'Frederiksen', 'Affiliation': 'Department of Pediatrics, Copenhagen University Hospital, Hvidovre.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Wewer', 'Affiliation': 'Department of Pediatrics, Copenhagen University Hospital, Hvidovre.'}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000003053'] 1985,33480123,Effectiveness and cost-effectiveness of the Transmural Trauma Care Model investigated in a multicenter trial with a controlled before-and-after design: A study protocol.,"OBJECTIVE The rehabilitation of trauma patients in primary care is challenging, and there are no guidelines for optimal treatment. Also, the organization of care is not well-structured. The Transmural Trauma Care Model (TTCM) has been developed in the Netherlands, aiming to improve patient outcomes by optimizing the organization and the quality of the rehabilitation process in primary care. A recent feasibility study showed that implementation of the TTCM at a Dutch Level 1 trauma center was feasible, patient outcomes were improved, and costs were reduced. This study aims to assess the effectiveness and cost-effectiveness of the TTCM compared to the usual care in a multicenter trial. METHODS A multicenter trial with a controlled before-and-after design will be performed at 10 hospitals in the Netherlands. First, participating hospitals will include 322 patients in the control group, receiving usual care as provided in these specific hospitals. Subsequently, the TTCM will be implemented in all participating hospitals, and hospitals will include an additional 322 patients in the intervention group. The TTCM consists of a multidisciplinary team at the outpatient clinic (trauma surgeon and hospital-based physical therapist), an educated and trained network of primary care trauma physical therapists, and structural communication between them. Co-primary outcomes will investigate generic and disease-specific, health-related quality of life. Secondary outcomes will include pain, patient satisfaction, perceived recovery, and patient-reported physical functioning. For the economic evaluation, societal and healthcare costs will be measured. Measurements will take place at baseline and after 6 weeks, 3, 6, and 9 months. Analyses will be based on the intention-to-treat principle. Missing data will be handled using longitudinal data analyses in the effect analyses and by multivariate imputation in the economic evaluation. CONCLUSION This trial with a controlled before-and-after design will give insight into the effectiveness and cost-effectiveness of the TTCM in a multicenter trial.",2021,"A recent feasibility study showed that implementation of the TTCM at a Dutch Level 1 trauma center was feasible, patient outcomes were improved, and costs were reduced.","['322 patients in the control group, receiving usual care as provided in these specific hospitals', '322 patients in the intervention group', '10 hospitals in the Netherlands']",['TTCM'],"['pain, patient satisfaction, perceived recovery, and patient-reported physical functioning', 'generic and disease-specific, health-related quality of life', 'Effectiveness and cost-effectiveness', 'effectiveness and cost-effectiveness']","[{'cui': 'C4517712', 'cui_str': '322'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0522497', 'cui_str': 'Transmural'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",322.0,0.133402,"A recent feasibility study showed that implementation of the TTCM at a Dutch Level 1 trauma center was feasible, patient outcomes were improved, and costs were reduced.","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Ratter', 'Affiliation': 'Department of Rehabilitation Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Wiertsema', 'Affiliation': 'Department of Rehabilitation Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Johanna M', 'Initials': 'JM', 'LastName': 'van Dongen', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Geleijn', 'Affiliation': 'Department of Rehabilitation Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Raymond W J G', 'Initials': 'RWJG', 'LastName': 'Ostelo', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'de Groot', 'Affiliation': 'Department of Rehabilitation Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Frank W', 'Initials': 'FW', 'LastName': 'Bloemers', 'Affiliation': 'Department of Trauma Surgery, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, The Netherlands.'}]",Physiotherapy research international : the journal for researchers and clinicians in physical therapy,['10.1002/pri.1894'] 1986,33495601,Off-treatment bone mineral density changes in postmenopausal women receiving anastrozole for 5 years: 7-year results from the IBIS-II prevention trial.,"BACKGROUND Anastrozole has been associated with substantial accelerated bone mineral density (BMD) loss during active treatment. METHODS One thousand four hundred and ten women were included in a BMD substudy and stratified into three strata according to their baseline T-score at spine or femoral neck. The primary objective of this analysis was to investigate whether DXA BMD at the spine and hip changed two years after treatment cessation (between years 5 and 7) in those who did not receive risedronate. RESULTS Five- and seven-year BMD data were available for a total of 528 women who did not receive risedronate. In women with normal BMD at baseline, an increase in BMD at the lumbar spine after anastrozole withdrawal was observed 1.25% (95% CI 0.73 to 1.77) (P = 0.0004), which was larger than in those on placebo (0.14% (-0.29 to 0.56))). At the hip, BMD remained unchanged between years 5 and 7 for those previously on anastrozole but continued to a decrease in those who had been randomised to placebo (-1.35% (-1.70 to -0.98)). CONCLUSIONS These are the first results reporting BMD changes after stopping anastrozole in a breast cancer prevention setting. Our results show that the negative effects of anastrozole on BMD in the preventive setting are partially reversible.",2021,"At the hip, BMD remained unchanged between years 5 and 7 for those previously on anastrozole but continued to a decrease in those who had been randomised to placebo (-1.35% (-1.70 to -0.98)). ","['postmenopausal women receiving anastrozole for 5 years', 'One thousand four hundred and ten women were included in a BMD substudy and stratified into three strata according to their baseline T-score at spine or femoral neck', '528 women who did not receive']","['anastrozole', 'risedronate', 'placebo', 'Anastrozole']","['bone mineral density (BMD) loss', 'BMD at the lumbar spine', 'DXA BMD']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0290883', 'cui_str': 'anastrozole'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0290883', 'cui_str': 'anastrozole'}, {'cui': 'C0246719', 'cui_str': 'Risedronate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}]",1410.0,0.323619,"At the hip, BMD remained unchanged between years 5 and 7 for those previously on anastrozole but continued to a decrease in those who had been randomised to placebo (-1.35% (-1.70 to -0.98)). ","[{'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Sestak', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University London, Charterhouse Square, London, EC1M 6BQ, UK. i.sestak@qmul.ac.uk.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Blake', 'Affiliation': ""School of Biomedical Engineering & Imaging Sciences, King's College London, St Thomas' Hospital, London, SE1 7EH, UK.""}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Patel', 'Affiliation': 'Imperial College London, London, SW7 2AZ, UK.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Cuzick', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University London, Charterhouse Square, London, EC1M 6BQ, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Howell', 'Affiliation': 'Division of Cancer Sciences, University of Manchester, Manchester, M13 9PL, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Coleman', 'Affiliation': 'Department of Oncology and Metabolism, University of Sheffield, Western Bank, Sheffield, S10 2TN, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Eastell', 'Affiliation': 'Department of Oncology and Metabolism, University of Sheffield, Western Bank, Sheffield, S10 2TN, UK.'}]",British journal of cancer,['10.1038/s41416-020-01228-2'] 1987,33499668,Association Between Sex and Treatment Outcomes of Atrial Fibrillation Ablation Versus Drug Therapy: Results From the CABANA Trial.,"BACKGROUND Among patients with atrial fibrillation (AF), women are less likely to receive catheter ablation and may have more complications and less durable results. Most information about sex-specific differences after ablation comes from observational data. We prespecified an examination of outcomes by sex in the 2204-patient CABANA trial (Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation). METHODS CABANA randomized patients with AF age ≥65 years or <65 years with ≥1 risk factor for stroke to a strategy of catheter ablation with pulmonary vein isolation versus drug therapy with rate/rhythm control agents. The primary composite outcome was death, disabling stroke, serious bleeding, or cardiac arrest, and key secondary outcomes included AF recurrence. RESULTS CABANA randomized 819 (37%) women (ablation 413, drug 406) and 1385 men (ablation 695, drug 690). Compared with men, women were older (median age, 69 years versus 67 years for men), were more symptomatic (48% Canadian Cardiovascular Society AF Severity Class 3 or 4 versus 39% for men), had more symptomatic heart failure (42% with New York Heart Association Class ≥II versus 32% for men), and more often had a paroxysmal AF pattern at enrollment (50% versus 39% for men) ( P <0.0001 for all). Women were less likely to have ancillary (nonpulmonary vein) ablation procedures performed during the index procedure (55.7% versus 62.2% in men, P =0.043), and complications from treatment were infrequent in both sexes. For the primary outcome, the hazard ratio for those who underwent ablation versus drug therapy was 1.01 (95% CI, 0.62-1.65) in women and 0.73 (95% CI, 0.51-1.05) in men (interaction P value=0.299). The risk of recurrent AF was significantly reduced in patients undergoing ablation compared with those receiving drug therapy regardless of sex, but the effect was greater in men (hazard ratio, 0.64 [95% CI, 0.51-0.82] for women versus hazard ratio, 0.48 [95% CI, 0.40-0.58] for men; interaction P value=0.060). CONCLUSIONS Clinically relevant treatment-related strategy differences in the primary and secondary clinical outcomes of CABANA were not seen between men and women, and there were no sex differences in adverse events. The CABANA trial results support catheter ablation as an effective treatment strategy for both women and men. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00911508.",2021,"The risk of recurrent AF was significantly reduced in patients undergoing ablation compared with those receiving drug therapy regardless of sex, but the effect was greater in men (HR 0.64, 95% CI 0.51-0.82 for women vs. HR 0.48, 95% CI 0.40-0.58 for men, interaction p value=0.060). ","['patients with AF age ≥65 or <65 with ≥1 risk factor for stroke to a strategy of catheter ablation with pulmonary vein isolation versus drug therapy with rate/rhythm control agents', 'patients with atrial fibrillation (AF', 'randomized 819 (37%) women (ablation 413, drug 406) and 1385 men (ablation 695, drug 690', 'women and men']","['catheter ablation', 'Atrial Fibrillation Ablation Versus Drug Therapy', '2204-patient Catheter Ablation vs. Antiarrhythmic Drug Therapy']","['death, disabling stroke, serious bleeding, or cardiac arrest, and key secondary outcomes included AF recurrence', 'hazard ratio (HR', 'risk of recurrent AF', 'adverse events', 'symptomatic heart failure', 'paroxysmal AF pattern']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",,0.254495,"The risk of recurrent AF was significantly reduced in patients undergoing ablation compared with those receiving drug therapy regardless of sex, but the effect was greater in men (HR 0.64, 95% CI 0.51-0.82 for women vs. HR 0.48, 95% CI 0.40-0.58 for men, interaction p value=0.060). ","[{'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Russo', 'Affiliation': 'Division of Cardiovascular Disease, Cooper Medical School of Rowan University, Camden, NJ (A.M.R.).'}, {'ForeName': 'Emily P', 'Initials': 'EP', 'LastName': 'Zeitler', 'Affiliation': 'The Geisel School of Medicine at Dartmouth, Hanover, NH, Division of Cardiology, Dartmouth-Hitchcock Medical Center, and The Dartmouth Institute, Lebanon, NH (E.P.Z.).'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Giczewska', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (A.G., A.P.S., H.R.A.-K., T.D.B., D.B.M.).'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Silverstein', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (A.G., A.P.S., H.R.A.-K., T.D.B., D.B.M.).'}, {'ForeName': 'Hussein R', 'Initials': 'HR', 'LastName': 'Al-Khalidi', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (A.G., A.P.S., H.R.A.-K., T.D.B., D.B.M.).'}, {'ForeName': 'Yong-Mei', 'Initials': 'YM', 'LastName': 'Cha', 'Affiliation': ""Mayo Clinic, St Mary's Campus, Rochester, MN (Y.-M.C., K.H.M., D.L.P.).""}, {'ForeName': 'Kristi H', 'Initials': 'KH', 'LastName': 'Monahan', 'Affiliation': ""Mayo Clinic, St Mary's Campus, Rochester, MN (Y.-M.C., K.H.M., D.L.P.).""}, {'ForeName': 'Tristram D', 'Initials': 'TD', 'LastName': 'Bahnson', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (A.G., A.P.S., H.R.A.-K., T.D.B., D.B.M.).'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (A.G., A.P.S., H.R.A.-K., T.D.B., D.B.M.).'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Packer', 'Affiliation': ""Mayo Clinic, St Mary's Campus, Rochester, MN (Y.-M.C., K.H.M., D.L.P.).""}, {'ForeName': 'Jeanne E', 'Initials': 'JE', 'LastName': 'Poole', 'Affiliation': 'University of Washington Medical Center, Seattle (J.E.P.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.120.051558'] 1988,33504955,Augmentation therapy with minocycline in treatment-resistant depression patients with low-grade peripheral inflammation: results from a double-blind randomised clinical trial.,"This study aimed to investigate the role of baseline levels of peripheral inflammation when testing the efficacy of antidepressant augmentation with minocycline in patients with treatment-resistant depression. We conducted a 4-week, placebo-controlled, randomised clinical trial of minocycline (200 mg/day) added to antidepressant treatment in 39 patients selected for elevated levels of serum C-reactive protein (CRP ≥ 1 mg/L), n = 18 randomised to minocycline (M) and n = 21 to placebo (P). The main outcome was the change in Hamilton Depression Rating Scale (HAM-D-17) score from baseline to week 4, expressed both as mean and as full or partial response, in the overall sample and after further stratification for baseline CRP≥3 mg/L. Secondary outcomes included changes in other clinical and inflammatory measures. Changes in HAM-D-17 scores and the proportion of partial responders did not differ between study arms. After stratification for CRP levels <3 mg/L (CRP - ) or ≥3 mg/L (CRP + ), CRP + /M patients showed the largest changes in HAM-D-17 scores (mean ± SD = 12.00 ± 6.45) compared with CRP - /M (2.42 ± 3.20, p < 0.001), CRP + /P (3.50 ± 4.34, p = 0.003) and CRP - /P (2.11 ± 3.26, p = 0.006) patients, and the largest proportion (83.3%, p = 0.04) of partial treatment response at week 4. The threshold point for baseline CRP to distinguish responders from non-responders to minocycline was 2.8 mg/L. Responders to minocycline had higher baseline IL-6 concentrations than non-responders (p = 0.03); IFNγ was significantly reduced after treatment with minocycline compared with placebo (p = 0.03). Our data show some evidence of efficacy of add-on treatment with minocycline in MDD patients but only in those with low-grade inflammation defined as CRP ≥3 mg/L.",2021,Changes in HAM-D-17 scores and the proportion of partial responders did not differ between study arms.,"['treatment-resistant depression patients with low-grade peripheral inflammation', 'patients with treatment-resistant depression', '39 patients selected for elevated levels of serum C-reactive protein (CRP\u2009≥\u20091\u2009mg/L), n\u2009']","['minocycline (M) and n\u2009=\u200921 to placebo (P', 'minocycline', 'placebo']","['IFNγ', 'HAM-D-17 scores', 'change in Hamilton Depression Rating Scale (HAM-D-17) score', 'changes in other clinical and inflammatory measures', 'baseline IL-6 concentrations']","[{'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0439268', 'cui_str': 'mg/L'}]","[{'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",39.0,0.318175,Changes in HAM-D-17 scores and the proportion of partial responders did not differ between study arms.,"[{'ForeName': 'Maria Antonietta', 'Initials': 'MA', 'LastName': 'Nettis', 'Affiliation': ""King's College London, Institute of Psychiatry Psychology and Neuroscience, Department of Psychological Medicine, London, UK.""}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Lombardo', 'Affiliation': ""King's College London, Institute of Psychiatry Psychology and Neuroscience, Department of Psychological Medicine, London, UK.""}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Hastings', 'Affiliation': ""King's College London, Institute of Psychiatry Psychology and Neuroscience, Department of Psychological Medicine, London, UK.""}, {'ForeName': 'Zuzanna', 'Initials': 'Z', 'LastName': 'Zajkowska', 'Affiliation': ""King's College London, Institute of Psychiatry Psychology and Neuroscience, Department of Psychological Medicine, London, UK.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Mariani', 'Affiliation': ""King's College London, Institute of Psychiatry Psychology and Neuroscience, Department of Psychological Medicine, London, UK.""}, {'ForeName': 'Naghmeh', 'Initials': 'N', 'LastName': 'Nikkheslat', 'Affiliation': ""King's College London, Institute of Psychiatry Psychology and Neuroscience, Department of Psychological Medicine, London, UK.""}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Worrell', 'Affiliation': ""King's College London, Institute of Psychiatry Psychology and Neuroscience, Department of Psychological Medicine, London, UK.""}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Enache', 'Affiliation': ""King's College London, Institute of Psychiatry Psychology and Neuroscience, Department of Psychological Medicine, London, UK.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'McLaughlin', 'Affiliation': ""King's College London, Institute of Psychiatry Psychology and Neuroscience, Department of Psychological Medicine, London, UK.""}, {'ForeName': 'Melisa', 'Initials': 'M', 'LastName': 'Kose', 'Affiliation': ""King's College London, Institute of Psychiatry Psychology and Neuroscience, Department of Psychological Medicine, London, UK.""}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Sforzini', 'Affiliation': ""King's College London, Institute of Psychiatry Psychology and Neuroscience, Department of Psychological Medicine, London, UK.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bogdanova', 'Affiliation': ""King's College London, Institute of Psychiatry Psychology and Neuroscience, Department of Psychological Medicine, London, UK.""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Cleare', 'Affiliation': ""King's College London, Institute of Psychiatry Psychology and Neuroscience, Department of Psychological Medicine, London, UK.""}, {'ForeName': 'Allan H', 'Initials': 'AH', 'LastName': 'Young', 'Affiliation': ""King's College London, Institute of Psychiatry Psychology and Neuroscience, Department of Psychological Medicine, London, UK.""}, {'ForeName': 'Carmine M', 'Initials': 'CM', 'LastName': 'Pariante', 'Affiliation': ""King's College London, Institute of Psychiatry Psychology and Neuroscience, Department of Psychological Medicine, London, UK.""}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Mondelli', 'Affiliation': ""King's College London, Institute of Psychiatry Psychology and Neuroscience, Department of Psychological Medicine, London, UK. valeria.mondelli@kcl.ac.uk.""}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00948-6'] 1989,33507360,Re: Results of a randomized trial of treatment modalities in patients with low or early‑intermediate risk prostate cancer (PREFERE trial).,"The authors of this ""Letter to the Editors"" express their major concern about selective and biased reporting in this paper.",2021,"The authors of this ""Letter to the Editors"" express their major concern about selective and biased reporting in this paper.",['patients with low or early‑intermediate risk prostate cancer (PREFERE trial'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],[],,0.0287849,"The authors of this ""Letter to the Editors"" express their major concern about selective and biased reporting in this paper.","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Boehle', 'Affiliation': 'Department of Urology, University of Luebeck, Ratzeburger Allee 160, Luebeck, 23562, Germany. boehle@urologie-bad-schwartau.de.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kahmann', 'Affiliation': 'MVZ Ihre Urologen GbR, Britzer Damm 63, 12347, Berlin, Germany.'}, {'ForeName': 'Thomas Oliver', 'Initials': 'TO', 'LastName': 'Henkel', 'Affiliation': 'MVZ Ihre Urologen GbR, Britzer Damm 63, 12347, Berlin, Germany.'}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Zimmermann', 'Affiliation': 'Praxiszentrum Alstertal, Heegbarg 2, 22391, Hamburg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Machtens', 'Affiliation': 'Department of Urology, Marien-Krankenhaus, Dr.-Robert-Koch-Straße 18, 51465, Bergisch Gladbach, Germany.'}]",Journal of cancer research and clinical oncology,['10.1007/s00432-020-03499-x'] 1990,33512666,Long-Term Safety and Efficacy of Risankizumab in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: Results from a Phase 2 Open-Label Extension Trial.,"INTRODUCTION Although many biologic therapies are effective for clearing skin of patients with psoriasis, some lose effectiveness over time. This phase 2 open-label extension (OLE) trial was designed to investigate the long-term safety and efficacy of risankizumab. METHODS In the phase 2, double-blind, active comparator, predecessor trial (NCT02054481), patients with moderate-to-severe chronic plaque psoriasis were treated for 24 weeks with subcutaneous (SC) risankizumab or ustekinumab, followed by a 24-week follow-up without treatment administration. Patients could enroll in the OLE (NCT02203851) when they experienced loss of treatment response (< 50% improvement in the Psoriasis Area Severity Index [PASI 50]) during follow-up) or at the end of follow-up if treatment response was ongoing. In the OLE, patients were treated every 12 weeks for at least 48 weeks with SC risankizumab 90 or 180 mg, beginning at week 12 (OLE visit 2), if the patient had not achieved PASI 90. Efficacy endpoints included the proportions of patients who achieved PASI 50/75/90/100 and static Physician's Global Assessment (sPGA) of clear or almost clear skin at week 48 (sPGA 0/1; OLE visit 5). RESULTS Of the 110 enrolled patients, 99 (90.0%) completed the OLE. No patients discontinued the study because of adverse events. At week 48, 74.1% of patients achieved PASI 90, whereas 98.1, 91.7, 53.7, and 67.6% achieved PASI 50/75/100 and sPGA 0/1, respectively. All efficacy results were consistent or slightly increased at OLE week 48 compared with week 12. No new safety findings were observed. CONCLUSION Risankizumab treatment was well tolerated with sustained clinical efficacy for at least 48 weeks. TRIAL REGISTRATION ClinicalTrials.gov identifier; NCT02203851.",2021,"At week 48, 74.1% of patients achieved PASI 90, whereas 98.1, 91.7, 53.7, and 67.6% achieved PASI 50/75/100 and sPGA 0/1, respectively.","['patients with psoriasis', 'Of the 110 enrolled patients, 99 (90.0%) completed the OLE', 'patients with moderate-to-severe chronic plaque psoriasis', 'Patients with Moderate-to-Severe Chronic Plaque Psoriasis']","['Risankizumab', 'subcutaneous (SC) risankizumab or ustekinumab', 'risankizumab']","[""proportions of patients who achieved PASI 50/75/90/100 and static Physician's Global Assessment (sPGA) of clear or almost clear skin"", 'tolerated with sustained clinical efficacy', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}]","[{'cui': 'C4505511', 'cui_str': 'risankizumab'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",110.0,0.0987288,"At week 48, 74.1% of patients achieved PASI 90, whereas 98.1, 91.7, 53.7, and 67.6% achieved PASI 50/75/100 and sPGA 0/1, respectively.","[{'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Papp', 'Affiliation': 'K Papp Clinical Research and Probity Medical Research, Waterloo, ON, Canada. kapapp@probitymedical.com.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'de Vente', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Jiewei', 'Initials': 'J', 'LastName': 'Zeng', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Flack', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Byron', 'Initials': 'B', 'LastName': 'Padilla', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Stephen K', 'Initials': 'SK', 'LastName': 'Tyring', 'Affiliation': 'University of Texas Health Science Center and Center for Clinical Studies, Houston, TX, USA.'}]",Dermatology and therapy,['10.1007/s13555-021-00490-3'] 1991,33509056,Brief breath awareness training yields poorer working memory performance in the context of acute stress.,"Mindfulness-based interventions that span multiple sessions over time appear to confer psychological benefits. However, the effects of brief periods of mindfulness meditation training are less clear, particularly on measures of cognitive functioning. This study assessed whether brief mindfulness practice (breath awareness) or training in two other contemplative practices - loving-kindness and gratitude - differentially impact working memory performance following acute physiological stress relative to an attentional control. Participants ( n  = 162) were randomly assigned to one of four training groups and completed the automated Operation Span (OSPAN) task pre-training and again after undergoing the cold pressor task. Three of the four groups improved in OSPAN performance, with loving-kindness, gratitude, and attentional control conditions showing increases in OSPAN relative to breath awareness. Changes in OSPAN were not correlated with changes in positive or negative affect. It appears that brief breath awareness training may not effectively buffer against acute stress in this predominantly meditation naïve sample and may in fact impair subsequent cognitive performance relative to a control or other contemplative practices. A granular approach is warranted to understand potentially distinct and contextually variable effects of different contemplative practices. Implications are discussed in light of the stress buffering hypothesis and Monitor and Acceptance Theory. Trial registration: ClinicalTrials.gov identifier: NCT02214264.",2021,"Three of the four groups improved in OSPAN performance, with loving-kindness, gratitude, and attentional control conditions showing increases in OSPAN relative to breath awareness.",['Participants ( n\u2009 =\u2009162'],"['mindfulness meditation training', 'automated Operation Span (OSPAN) task pre-training and again after undergoing the cold pressor task', 'mindfulness practice (breath awareness) or training in two other contemplative practices - loving-kindness and gratitude - differentially impact working memory performance']","['Changes in OSPAN', 'OSPAN relative to breath awareness', 'OSPAN performance']","[{'cui': 'C5191360', 'cui_str': '162'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0024028', 'cui_str': 'Love'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]",162.0,0.0229554,"Three of the four groups improved in OSPAN performance, with loving-kindness, gratitude, and attentional control conditions showing increases in OSPAN relative to breath awareness.","[{'ForeName': 'Simon B', 'Initials': 'SB', 'LastName': 'Goldberg', 'Affiliation': 'Center for Healthy Minds, University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Flook', 'Affiliation': 'Center for Healthy Minds, University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Hirshberg', 'Affiliation': 'Center for Healthy Minds, University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Davidson', 'Affiliation': 'Center for Healthy Minds, University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Stacey M', 'Initials': 'SM', 'LastName': 'Schaefer', 'Affiliation': 'Center for Healthy Minds, University of Wisconsin-Madison, Madison, WI, USA.'}]",Cognition & emotion,['10.1080/02699931.2021.1878113'] 1992,33515070,Oral insulin immunotherapy in children at risk for type 1 diabetes in a randomised controlled trial.,"AIMS/HYPOTHESIS Oral administration of antigen can induce immunological tolerance. Insulin is a key autoantigen in childhood type 1 diabetes. Here, oral insulin was given as antigen-specific immunotherapy before the onset of autoimmunity in children from age 6 months to assess its safety and immune response actions on immunity and the gut microbiome. METHODS A phase I/II randomised controlled trial was performed in a single clinical study centre in Germany. Participants were 44 islet autoantibody-negative children aged 6 months to 2.99 years who had a first-degree relative with type 1 diabetes and a susceptible HLA DR4-DQ8-containing genotype. Children were randomised 1:1 to daily oral insulin (7.5 mg with dose escalation to 67.5 mg) or placebo for 12 months using a web-based computer system. The primary outcome was immune efficacy pre-specified as induction of antibody or T cell responses to insulin and measured in a central treatment-blinded laboratory. RESULTS Randomisation was performed in 44 children. One child in the placebo group was withdrawn after the first study visit and data from 22 insulin-treated and 21 placebo-treated children were analysed. Oral insulin was well tolerated with no changes in metabolic variables. Immune responses to insulin were observed in children who received both insulin (54.5%) and placebo (66.7%), and the trial did not demonstrate an effect on its primary outcome (p = 0.54). In exploratory analyses, there was preliminary evidence that the immune response and gut microbiome were modified by the INS genotype Among children with the type 1 diabetes-susceptible INS genotype (n = 22), antibody responses to insulin were more frequent in insulin-treated (72.7%) as compared with placebo-treated children (18.2%; p = 0.03). T cell responses to insulin were modified by treatment-independent inflammatory episodes. CONCLUSIONS/INTERPRETATION The study demonstrated that oral insulin immunotherapy in young genetically at-risk children was safe, but was not associated with an immune response as predefined in the trial primary outcome. Exploratory analyses suggested that antibody responses to oral insulin may occur in children with a susceptible INS genotype, and that inflammatory episodes may promote the activation of insulin-responsive T cells. TRIAL REGISTRATION Clinicaltrials.gov NCT02547519 FUNDING: The main funding source was the German Center for Diabetes Research (DZD e.V.).",2021,"In exploratory analyses, there was preliminary evidence that the immune response and gut microbiome were modified by the INS genotype Among children with the type 1 diabetes-susceptible INS genotype (n = 22), antibody responses to insulin were more frequent in insulin-treated (72.7%) as compared with placebo-treated children (18.2%; p = 0.03).","['Participants were 44 islet autoantibody-negative children aged 6\xa0months to 2.99\xa0years who had a first-degree relative with type 1 diabetes and a susceptible HLA DR4-DQ8-containing genotype', 'children with a susceptible INS genotype', 'single clinical study centre in Germany', 'young genetically at-risk children', '44 children', 'children at risk for type 1 diabetes']","['Insulin', 'placebo', 'Oral insulin immunotherapy', 'daily oral insulin', 'oral insulin', 'oral insulin immunotherapy']","['immunological tolerance', 'immune efficacy pre-specified as induction of antibody or T cell responses to insulin and measured in a central treatment-blinded laboratory', 'immune response and gut microbiome', 'antibody responses to insulin', 'Immune responses to insulin']","[{'cui': 'C0911524', 'cui_str': 'AM 44'}, {'cui': 'C0854162', 'cui_str': 'Autoantibody negative'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444502', 'cui_str': 'First degree'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0231204', 'cui_str': 'Susceptible'}, {'cui': 'C0019774', 'cui_str': 'Human leukocyte antigen DR4'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0425119', 'cui_str': 'Child at risk'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0020963', 'cui_str': 'Immunologic tolerance'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}]",44.0,0.502356,"In exploratory analyses, there was preliminary evidence that the immune response and gut microbiome were modified by the INS genotype Among children with the type 1 diabetes-susceptible INS genotype (n = 22), antibody responses to insulin were more frequent in insulin-treated (72.7%) as compared with placebo-treated children (18.2%; p = 0.03).","[{'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Assfalg', 'Affiliation': 'Institute of Diabetes Research, Helmholtz Zentrum München, German Research Center for Environmental Health, Munich-Neuherberg, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Knoop', 'Affiliation': 'Institute of Diabetes Research, Helmholtz Zentrum München, German Research Center for Environmental Health, Munich-Neuherberg, Germany.'}, {'ForeName': 'Kristi L', 'Initials': 'KL', 'LastName': 'Hoffman', 'Affiliation': 'Alkek Center for Metagenomics and Microbiome Research, Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Pfirrmann', 'Affiliation': 'Institute for Medical Information Processing, Biometry, and Epidemiology, Ludwig-Maximilians-University Munich, Munich, Germany.'}, {'ForeName': 'Jose Maria', 'Initials': 'JM', 'LastName': 'Zapardiel-Gonzalo', 'Affiliation': 'Institute of Diabetes Research, Helmholtz Zentrum München, German Research Center for Environmental Health, Munich-Neuherberg, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hofelich', 'Affiliation': 'Forschergruppe Diabetes, Technical University Munich, at Klinikum rechts der Isar, Munich, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Eugster', 'Affiliation': 'Technische Universität Dresden, Center for Regenerative Therapies Dresden, Dresden, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Weigelt', 'Affiliation': 'Technische Universität Dresden, Center for Regenerative Therapies Dresden, Dresden, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Matzke', 'Affiliation': 'Institute of Diabetes Research, Helmholtz Zentrum München, German Research Center for Environmental Health, Munich-Neuherberg, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Reinhardt', 'Affiliation': 'Technische Universität Dresden, Center for Regenerative Therapies Dresden, Dresden, Germany.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Fuchs', 'Affiliation': 'Technische Universität Dresden, Center for Regenerative Therapies Dresden, Dresden, Germany.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Bunk', 'Affiliation': 'Institute of Diabetes Research, Helmholtz Zentrum München, German Research Center for Environmental Health, Munich-Neuherberg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Weiss', 'Affiliation': 'Institute of Diabetes Research, Helmholtz Zentrum München, German Research Center for Environmental Health, Munich-Neuherberg, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Hippich', 'Affiliation': 'Institute of Diabetes Research, Helmholtz Zentrum München, German Research Center for Environmental Health, Munich-Neuherberg, Germany.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Halfter', 'Affiliation': 'Institute for Medical Information Processing, Biometry, and Epidemiology, Ludwig-Maximilians-University Munich, Munich, Germany.'}, {'ForeName': 'Stefanie M', 'Initials': 'SM', 'LastName': 'Hauck', 'Affiliation': 'Research Unit Protein Science, Helmholtz Zentrum München, German Research Center for Environmental Health, Munich-Neuherberg, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Hasford', 'Affiliation': 'Institute for Medical Information Processing, Biometry, and Epidemiology, Ludwig-Maximilians-University Munich, Munich, Germany.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Petrosino', 'Affiliation': 'Alkek Center for Metagenomics and Microbiome Research, Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Achenbach', 'Affiliation': 'Institute of Diabetes Research, Helmholtz Zentrum München, German Research Center for Environmental Health, Munich-Neuherberg, Germany.'}, {'ForeName': 'Ezio', 'Initials': 'E', 'LastName': 'Bonifacio', 'Affiliation': 'German Center for Diabetes Research (DZD), Munich, Germany.'}, {'ForeName': 'Anette-Gabriele', 'Initials': 'AG', 'LastName': 'Ziegler', 'Affiliation': 'Institute of Diabetes Research, Helmholtz Zentrum München, German Research Center for Environmental Health, Munich-Neuherberg, Germany. anette-g.ziegler@helmholtz-muenchen.de.'}]",Diabetologia,['10.1007/s00125-020-05376-1'] 1993,33479782,"""Being There"" vs ""Being Direct:"" Perspectives of Persons with Serious Mental Illness on Receiving Support with Physical Health from Peer and Non-Peer Providers.","Individuals with serious mental illness (SMI) face significant health disparities and multiple barriers to engaging in health behavior change. To reduce these health disparities, it is necessary to enhance the support individuals with SMI receive through the collaboration of different healthcare providers. This study explored how people with SMI living in supportive housing perceived receiving support from peer and non-peer providers for their physical health. Qualitative interviews were conducted with 28 participants receiving a peer-led healthy lifestyle intervention in the context of a randomized trial in supportive housing agencies. Interviews explored participants' experiences working with the healthy lifestyle peer specialist and a non-peer provider who assisted them with health. Interviews were audio recorded, transcribed, and analyzed using strategies rooted in grounded theory. Participants viewed their relationships with peer and non-peer providers positively, but described differences in the approach to practice, power dynamics present, and how they identified with each provider. Participants described peers as process-oriented while non-peer staff as task-oriented, focusing on accomplishing concrete objectives. Each provider sought to boost participants' motivation, but peers built hope by emphasizing the possibility of change, while non-peer providers emphasized the consequences of inaction. Participants related to peer staff through shared experiences, while identifying the importance of having a shared treatment goal with their non-peer provider. Overall, participants appreciated the unique roles of both peer and non-peer staff in supporting their health. Study findings have implications for integrating the use of peer-based health interventions to improve the health of people with SMI.",2021,Study findings have implications for integrating the use of peer-based health interventions to improve the health of people with SMI.,"['people with SMI living in supportive housing perceived receiving support from peer and non-peer providers for their physical health', 'Individuals with serious mental illness (SMI', 'Persons with Serious Mental Illness', '28 participants receiving a']","['healthy lifestyle peer specialist and a non-peer provider who assisted them with health', 'peer-led healthy lifestyle intervention']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],28.0,0.0316009,Study findings have implications for integrating the use of peer-based health interventions to improve the health of people with SMI.,"[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Bochicchio', 'Affiliation': 'Columbia University School of Nursing, 550 West 168th Street, New York, NY, 10032, USA.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Stefancic', 'Affiliation': 'Columbia University Department of Psychiatry, 1051 Riverside Dr., Rm 6203, New York, NY, 10031, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'McTavish', 'Affiliation': 'New York University Department of Child and Adolescent Psychiatry, 1 Park Avenue, New York, NY, 10016, USA.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Tuda', 'Affiliation': 'Columbia University Department of Psychiatry, 1051 Riverside Dr., Rm 3205, New York, NY, 10031, USA.'}, {'ForeName': 'Leopoldo J', 'Initials': 'LJ', 'LastName': 'Cabassa', 'Affiliation': 'Brown School of Social Work at Washington University in St. Louis, Goldfarb Hall, Room 358, Campus Box 1196, One Brookings Drive, St. Louis, MO, 63130, USA. Ljcabassa@wustl.edu.'}]",Administration and policy in mental health,['10.1007/s10488-020-01098-z'] 1994,33495545,Accelerated brain aging predicts impulsivity and symptom severity in depression.,"Multiple structural and functional neuroimaging measures vary over the course of the lifespan and can be used to predict chronological age. Accelerated brain aging, as quantified by deviations in the MRI-based predicted age with respect to chronological age, is associated with risk for neurodegenerative conditions, bipolar disorder, and mortality. Whether age-related changes in resting-state functional connectivity are accelerated in major depressive disorder (MDD) is unknown, and, if so, it is unclear if these changes contribute to specific cognitive weaknesses that often occur in MDD. Here, we delineated age-related functional connectivity changes in a large sample of normal control subjects and tested whether brain aging is accelerated in MDD. Furthermore, we tested whether accelerated brain aging predicts individual differences in cognitive function. We trained a support vector regression model predicting age using resting-state functional connectivity in 710 healthy adults aged 18-89. We applied this model trained on normal aging subjects to a sample of actively depressed MDD participants (n = 109). The difference between predicted brain age and chronological age was 2.11 years greater (p = 0.015) in MDD patients compared to control participants. An older MDD brain age was significantly associated with increased impulsivity and, in males, increased depressive severity. Unexpectedly, accelerated brain aging was also associated with increased placebo response in a sham-controlled trial of high-frequency repetitive transcranial magnetic stimulation targeting the dorsomedial prefrontal cortex. Our results indicate that MDD is associated with accelerated brain aging, and that accelerated aging is selectively associated with greater impulsivity and depression severity.",2021,The difference between predicted brain age and chronological age was 2.11 years greater (p = 0.015) in MDD patients compared to control participants.,"['normal aging subjects to a sample of actively depressed MDD participants (n\u2009=\u2009109', '710 healthy adults aged 18-89']",['support vector regression model predicting age using resting-state functional connectivity'],['depressive severity'],"[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}]",710.0,0.0319125,The difference between predicted brain age and chronological age was 2.11 years greater (p = 0.015) in MDD patients compared to control participants.,"[{'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Dunlop', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medicine, New York, NY, USA. kad2032@med.cornell.edu.'}, {'ForeName': 'Lindsay W', 'Initials': 'LW', 'LastName': 'Victoria', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Downar', 'Affiliation': 'Department of Psychiatry and Krembil Research Institute, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Faith M', 'Initials': 'FM', 'LastName': 'Gunning', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medicine, New York, NY, USA. fgd2002@med.cornell.edu.'}, {'ForeName': 'Conor', 'Initials': 'C', 'LastName': 'Liston', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medicine, New York, NY, USA. col2004@med.cornell.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-021-00967-x'] 1995,33495363,Arsenic trioxide replacing or reducing chemotherapy in consolidation therapy for acute promyelocytic leukemia (APL2012 trial).,"As all- trans retinoic acid (ATRA) and arsenic trioxide (ATO) are widely accepted in treating acute promyelocytic leukemia (APL), deescalating toxicity becomes a research hotspot. Here, we evaluated whether chemotherapy could be replaced or reduced by ATO in APL patients at different risks. After achieving complete remission with ATRA-ATO-based induction therapy, patients were randomized (1:1) into ATO and non-ATO groups for consolidation: ATRA-ATO versus ATRA-anthracycline for low-/intermediate-risk patients, or ATRA-ATO-anthracycline versus ATRA-anthracycline-cytarabine for high-risk patients. The primary end point was to assess disease-free survival (DFS) at 3 y by a noninferiority margin of -5%; 855 patients were enrolled with a median follow-up of 54.9 mo, and 658 of 755 patients could be evaluated at 3 y. In the ATO group, 96.1% (319/332) achieved 3-y DFS, compared to 92.6% (302/326) in the non-ATO group. The difference was 3.45% (95% CI -0.07 to 6.97), confirming noninferiority ( P < 0.001). Using the Kaplan-Meier method, the estimated 7-y DFS was 95.7% (95% CI 93.6 to 97.9) in ATO and 92.6% (95% CI 89.8 to 95.4) in non-ATO groups ( P = 0.066). Concerning secondary end points, the 7-y cumulative incidence of relapse (CIR) was significantly lower in ATO (2.2% [95% CI 1.1 to 4.2]) than in non-ATO group (6.1% [95% CI 3.9 to 9.5], P = 0.011). In addition, grade 3 to 4 hematological toxicities were significantly reduced in the ATO group during consolidation. Hence, ATRA-ATO in both chemotherapy-replacing and -reducing settings in consolidation is not inferior to ATRA-chemotherapy (https://www.clinicaltrials.gov/, NCT01987297).",2021,"In the ATO group, 96.1% (319/332) achieved 3-y DFS, compared to 92.6% (302/326) in the non-ATO group.","['855 patients were enrolled with a median follow-up of 54.9 mo, and 658 of 755 patients could be evaluated at 3 y', 'acute promyelocytic leukemia (APL2012 trial']","['ATRA-anthracycline', 'arsenic trioxide (ATO', 'ATRA-ATO-anthracycline versus ATRA-anthracycline-cytarabine', 'Arsenic trioxide replacing or reducing chemotherapy']","['7-y cumulative incidence of relapse (CIR', 'disease-free survival (DFS', 'grade 3 to 4 hematological toxicities']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517872', 'cui_str': '755'}, {'cui': 'C0023487', 'cui_str': 'Acute promyelocytic leukemia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0052416', 'cui_str': 'arsenic trioxide'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",855.0,0.086615,"In the ATO group, 96.1% (319/332) achieved 3-y DFS, compared to 92.6% (302/326) in the non-ATO group.","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics, National Research Center for Translational Medicine at Shanghai, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 200025 Shanghai, China.'}, {'ForeName': 'Hong-Ming', 'Initials': 'HM', 'LastName': 'Zhu', 'Affiliation': 'Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics, National Research Center for Translational Medicine at Shanghai, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 200025 Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Hematology, First Hospital of China Medical University, 110001 Shenyang, China.'}, {'ForeName': 'Qi-Fa', 'Initials': 'QF', 'LastName': 'Liu', 'Affiliation': 'Department of Hematology, Nanfang Hospital of Southern Medical University, 510515 Guangzhou, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Hematology, Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 430022 Wuhan, China.'}, {'ForeName': 'Jian-Feng', 'Initials': 'JF', 'LastName': 'Zhou', 'Affiliation': 'Department of Hematology, Tong Ji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 430030 Wuhan, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of Zhejiang University College of Medicine, 310006 Hangzhou, China.'}, {'ForeName': 'Jian-Da', 'Initials': 'JD', 'LastName': 'Hu', 'Affiliation': 'Department of Hematology, Fujian Medical University Union Hospital, 350001 Fuzhou, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Department of Hematology, West China Hospital, Sichuan University, 610041 Chengdu, China.'}, {'ForeName': 'De-Pei', 'Initials': 'DP', 'LastName': 'Wu', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of Soochow University, 215006 Suzhou, China.'}, {'ForeName': 'Jie-Ping', 'Initials': 'JP', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology, Southwest Hospital, Third Military Medical University, 400038 Chongqing, China.'}, {'ForeName': 'Yong-Rong', 'Initials': 'YR', 'LastName': 'Lai', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of Guangxi Medical University, 530021 Nanning, China.'}, {'ForeName': 'Jian-Xiang', 'Initials': 'JX', 'LastName': 'Wang', 'Affiliation': 'Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 300020 Tianjin, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of Sun Yat-sen University, 510080 Guangzhou, China.'}, {'ForeName': 'Jian-Yong', 'Initials': 'JY', 'LastName': 'Li', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of Nanjing Medical University, 210029 Nanjing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': ""Department of Hematology, Guangdong Province People's Hospital, Guangdong Academy of Medical Sciences, 510055 Guangzhou, China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong University, 250021 Jinan, China.'}, {'ForeName': 'Ming-Zhen', 'Initials': 'MZ', 'LastName': 'Yang', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of Anhui Medical University, 230022 Hefei, China.'}, {'ForeName': 'Jin-Song', 'Initials': 'JS', 'LastName': 'Yan', 'Affiliation': 'Department of Hematology, The Second Affiliated Hospital of Dalian Medical University, 116027 Dalian, China.'}, {'ForeName': 'Gui-Fang', 'Initials': 'GF', 'LastName': 'Ouyang', 'Affiliation': 'Department of Hematology, Ningbo First Hospital, 315010 Ningbo, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Hematology, Tangdu Hospital, Fourth Military Medical University, 710038 Xi'an, China.""}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Hou', 'Affiliation': 'Department of Hematology, Qilu Hospital of Shandong University, 250012 Jinan, China.'}, {'ForeName': 'Xiao-Jun', 'Initials': 'XJ', 'LastName': 'Huang', 'Affiliation': ""Department of Hematology, Peking University People's Hospital, 100044 Beijing, China.""}, {'ForeName': 'Xiao-Jing', 'Initials': 'XJ', 'LastName': 'Yan', 'Affiliation': 'Department of Hematology, First Hospital of China Medical University, 110001 Shenyang, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': 'Department of Hematology, Nanfang Hospital of Southern Medical University, 510515 Guangzhou, China.'}, {'ForeName': 'Wei-Ming', 'Initials': 'WM', 'LastName': 'Li', 'Affiliation': 'Department of Hematology, Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 430022 Wuhan, China.'}, {'ForeName': 'Deng-Ju', 'Initials': 'DJ', 'LastName': 'Li', 'Affiliation': 'Department of Hematology, Tong Ji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 430030 Wuhan, China.'}, {'ForeName': 'Yin-Jun', 'Initials': 'YJ', 'LastName': 'Lou', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of Zhejiang University College of Medicine, 310006 Hangzhou, China.'}, {'ForeName': 'Zheng-Jun', 'Initials': 'ZJ', 'LastName': 'Wu', 'Affiliation': 'Department of Hematology, Fujian Medical University Union Hospital, 350001 Fuzhou, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Niu', 'Affiliation': 'Department of Hematology, West China Hospital, Sichuan University, 610041 Chengdu, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of Soochow University, 215006 Suzhou, China.'}, {'ForeName': 'Xiao-Yang', 'Initials': 'XY', 'LastName': 'Li', 'Affiliation': 'Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics, National Research Center for Translational Medicine at Shanghai, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 200025 Shanghai, China.'}, {'ForeName': 'Jian-Hua', 'Initials': 'JH', 'LastName': 'You', 'Affiliation': 'Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics, National Research Center for Translational Medicine at Shanghai, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 200025 Shanghai, China.'}, {'ForeName': 'Hui-Jin', 'Initials': 'HJ', 'LastName': 'Zhao', 'Affiliation': 'Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics, National Research Center for Translational Medicine at Shanghai, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 200025 Shanghai, China.'}, {'ForeName': 'Yú', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics, National Research Center for Translational Medicine at Shanghai, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 200025 Shanghai, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics, National Research Center for Translational Medicine at Shanghai, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 200025 Shanghai, China.'}, {'ForeName': 'Qiu-Sheng', 'Initials': 'QS', 'LastName': 'Chen', 'Affiliation': 'Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics, National Research Center for Translational Medicine at Shanghai, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 200025 Shanghai, China.'}, {'ForeName': 'Yù', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics, National Research Center for Translational Medicine at Shanghai, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 200025 Shanghai, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Clinical Research Center, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 200025 Shanghai, China.'}, {'ForeName': 'Bing-Shun', 'Initials': 'BS', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Clinical Research Center, Shanghai Jiao Tong University School of Medicine, 200025 Shanghai, China.'}, {'ForeName': 'Wei-Li', 'Initials': 'WL', 'LastName': 'Zhao', 'Affiliation': 'Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics, National Research Center for Translational Medicine at Shanghai, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 200025 Shanghai, China.'}, {'ForeName': 'Jian-Qing', 'Initials': 'JQ', 'LastName': 'Mi', 'Affiliation': 'Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics, National Research Center for Translational Medicine at Shanghai, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 200025 Shanghai, China.'}, {'ForeName': 'Kan-Kan', 'Initials': 'KK', 'LastName': 'Wang', 'Affiliation': 'Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics, National Research Center for Translational Medicine at Shanghai, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 200025 Shanghai, China.'}, {'ForeName': 'Jiong', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics, National Research Center for Translational Medicine at Shanghai, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 200025 Shanghai, China.'}, {'ForeName': 'Zhu', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics, National Research Center for Translational Medicine at Shanghai, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 200025 Shanghai, China; zchen@stn.sh.cn sjchen@stn.sh.cn ljm10378@rjh.com.cn.'}, {'ForeName': 'Sai-Juan', 'Initials': 'SJ', 'LastName': 'Chen', 'Affiliation': 'Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics, National Research Center for Translational Medicine at Shanghai, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 200025 Shanghai, China; zchen@stn.sh.cn sjchen@stn.sh.cn ljm10378@rjh.com.cn.'}, {'ForeName': 'Jun-Min', 'Initials': 'JM', 'LastName': 'Li', 'Affiliation': 'Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics, National Research Center for Translational Medicine at Shanghai, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 200025 Shanghai, China; zchen@stn.sh.cn sjchen@stn.sh.cn ljm10378@rjh.com.cn.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.2020382118'] 1996,33493393,Continuing besifovir dipivoxil maleate versus switching from tenofovir disoproxil fumarate for treatment of chronic hepatitis B: Results of 192-week phase 3 trial.,"BACKGROUND/AIMS Besifovir dipivoxil maleate (BSV), an acyclic nucleotide phosphonate, shows potent antiviral activity against hepatitis B virus. Our previous 48-week trial revealed that BSV has comparable antiviral efficacy to tenofovir disoproxil fumarate (TDF) and better safety profiles in terms of improved renal and bone safety. This extension study evaluated the prolonged efficacy and safety of BSV in treatment-naive chronic hepatitis B patients. METHODS Patients continued to participate in an open-label BSV study after an initial 48-week double-blind comparison of BSV and TDF treatment. The antiviral efficacy and drug safety was evaluated up to 192 weeks in two groups: patients continuing BSV treatment (BSV-BSV) and patients switching from TDF to BSV after 48 weeks (TDF-BSV). RESULTS Among 197 patients receiving randomized treatments, 170 (86%) entered the open-label phase and 152 (77%) entered the 192-week extension study. Virological response rates over 192 weeks were 92.50% and 93.06% in the BSV-BSV and TDF-BSV groups, respectively (P=0.90). Hepatitis B envelop antigen seroconversion and alanine aminotransferase normalization rates were similar between the groups (P=0.75 and P=0.36, respectively). There were no drug-resistant mutations to BSV. Bone mineral density and renal function were well preserved in the BSV-BSV group, whereas these initially worsened then recovered after switching therapy in the TDF-BSV group. CONCLUSION BSV maintained potent antiviral efficacy after 192 weeks and showed no evidence of drug resistance. BSV was safe, well tolerated, and effective in patients who switched from TDF to BSV. Trial Registration Number: NCT01937806 (date: 10 Sep 2013).",2021,"Hepatitis B envelop antigen seroconversion and alanine aminotransferase normalization rates were similar between the groups (p = 0.75 and p = 0.36, respectively).","['Chronic Hepatitis B', '197 patients receiving randomized treatments, 170 (86%) entered the open-label phase and 152 (77%) entered the 192-week extension study', 'treatment-naive chronic hepatitis B patients']","['BSV and TDF treatment', 'tenofovir disoproxil fumarate (TDF', 'Besifovir dipivoxil maleate (BSV', 'BSV', 'Continuing Besifovir Dipivoxil Maleate Versus Switching from Tenofovir Disoproxil Fumarate']","['Bone mineral density and renal function', 'antiviral efficacy and drug safety', 'Hepatitis B envelop antigen seroconversion and alanine aminotransferase normalization rates', 'antiviral efficacy', 'renal and bone safety', 'Virological response rates', 'BSV was safe, well tolerated, and effective']","[{'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4080032', 'cui_str': 'besifovir'}, {'cui': 'C0024572', 'cui_str': 'Maleates'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C4080032', 'cui_str': 'besifovir'}, {'cui': 'C0024572', 'cui_str': 'Maleates'}]",,0.0675746,"Hepatitis B envelop antigen seroconversion and alanine aminotransferase normalization rates were similar between the groups (p = 0.75 and p = 0.36, respectively).","[{'ForeName': 'Do Seon', 'Initials': 'DS', 'LastName': 'Song', 'Affiliation': ""Department of Internal Medicine, St. Vincent's Hospital, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Won', 'Initials': 'W', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul Metropolitan Government Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sang Hoon', 'Initials': 'SH', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyung Joon', 'Initials': 'HJ', 'LastName': 'Yim', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jae Young', 'Initials': 'JY', 'LastName': 'Jang', 'Affiliation': 'Department of Internal Medicine, College of Medicine, Soonchunhyang University, Seoul, Korea.'}, {'ForeName': 'Young Oh', 'Initials': 'YO', 'LastName': 'Kweon', 'Affiliation': 'Department of Internal Medicine, Kyungpook National University College of Medicine, Daegu, Korea.'}, {'ForeName': 'Yong Kyun', 'Initials': 'YK', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Yoon Jun', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Gun Young', 'Initials': 'GY', 'LastName': 'Hong', 'Affiliation': 'Department of Internal Medicine, Kwangju Christian Hospital, Gwangju, Korea.'}, {'ForeName': 'Dong Joon', 'Initials': 'DJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine and Center for Liver and Digestive Diseases, Hallym University, Chuncheon, Korea.'}, {'ForeName': 'Young Kul', 'Initials': 'YK', 'LastName': 'Jung', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Joo Hyun', 'Initials': 'JH', 'LastName': 'Sohn', 'Affiliation': 'Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jin-Woo', 'Initials': 'JW', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Inha University School of Medicine, Incheon, Korea.'}, {'ForeName': 'Sung Jae', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Paik Hospital, Inje University, Busan, Korea.'}, {'ForeName': 'Byung Seok', 'Initials': 'BS', 'LastName': 'Lee', 'Affiliation': 'Department of Gastroenterology and Hepatology, Chungnam National University School of Medicine, Daejeon, Korea.'}, {'ForeName': 'Ju Hyun', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Gacheon University College of Medicine, Incheon, Korea.'}, {'ForeName': 'Hong Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea.'}, {'ForeName': 'Seung Kew', 'Initials': 'SK', 'LastName': 'Yoon', 'Affiliation': ""Department of Internal Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Moon Young', 'Initials': 'MY', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea.'}, {'ForeName': 'Kwan Sik', 'Initials': 'KS', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Young Suk', 'Initials': 'YS', 'LastName': 'Lim', 'Affiliation': 'Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Wan Sik', 'Initials': 'WS', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Chonnam University Medical School, Gwangju, Korea.'}, {'ForeName': 'Jin Mo', 'Initials': 'JM', 'LastName': 'Yang', 'Affiliation': ""Department of Internal Medicine, St. Vincent's Hospital, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Kyun-Hwan', 'Initials': 'KH', 'LastName': 'Kim', 'Affiliation': 'Department of Precision Medicine, Sungkyunkwan University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Kwang-Hyub', 'Initials': 'KH', 'LastName': 'Han', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Soon Ho', 'Initials': 'SH', 'LastName': 'Um', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.'}]",Clinical and molecular hepatology,['10.3350/cmh.2020.0307'] 1997,33500355,Baseline Circulating Tumor Cell Count as a Prognostic Marker of PSA Response and Disease Progression in Metastatic Castrate-Sensitive Prostate Cancer (SWOG S1216).,"PURPOSE In metastatic castrate-sensitive prostate cancer (mCSPC), combined androgen axis inhibition is a standard of care. Noninvasive biomarkers that guide initial therapy decisions are needed. We hypothesized that CellSearch circulating tumor cell (CTC) count, an FDA-cleared assay in metastatic castrate-resistant prostate cancer (mCRPC), is a relevant biomarker in mCSPC. EXPERIMENTAL DESIGN SWOG S1216 is a phase III prospective randomized trial of androgen deprivation therapy (ADT) combined with orteronel or bicalutamide for mCSPC. CellSearch CTC count was measured at registration (baseline). Prespecified CTC cut-off points of 0, 1-4, and ≥5 were correlated with baseline patient characteristics and, in a stratified subsample, were also correlated with two prespecified trial secondary endpoints: 7-month PSA ≤0.2 ng/mL versus 0.2-4.0 versus >4.0 (intermediate endpoint for overall survival); and progression-free survival (PFS) ≤ versus >2 years. RESULTS A total of 523 patients submitted baseline samples, and CTCs were detected (median 3) in 33%. Adjusting for two trial stratification factors (disease burden and timing of ADT initiation), men with undetectable CTCs had nearly nine times the odds of attaining 7-month PSA ≤ 0.2 versus > 4.0 [OR 8.8, 95% confidence interval (CI), 2.7-28.6, P < 0.001, N = 264] and four times the odds of achieving > 2 years PFS (OR 4.0, 95% CI, 1.9-8.5, P < 0.001, N = 336) compared with men with baseline CTCs ≥5. CONCLUSIONS Baseline CTC count in mCSPC is highly prognostic of 7-month PSA and 2-year PFS after adjusting for disease burden and discriminates men who are likely to experience poor survival outcomes.",2021,Baseline CTC count in mCSPC is highly prognostic of 7-month PSA and 2-year PFS after adjusting for disease burden and discriminates men who are likely to experience poor survival outcomes.,"['men with undetectable CTCs had nearly 9-times', 'metastatic castrate sensitive prostate cancer (mCSPC']",['androgen deprivation therapy (ADT) combined with orteronel or bicalutamide'],"['overall survival); and progression-free survival (PFS) ', 'CellSearch CTC count']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer'}]","[{'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C2983781', 'cui_str': 'orteronel'}, {'cui': 'C0285590', 'cui_str': 'bicalutamide'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",523.0,0.0531348,Baseline CTC count in mCSPC is highly prognostic of 7-month PSA and 2-year PFS after adjusting for disease burden and discriminates men who are likely to experience poor survival outcomes.,"[{'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Goldkorn', 'Affiliation': 'University of Southern California Norris Comprehensive Cancer Center and Keck School of Medicine, Los Angeles, California. agoldkor@med.usc.edu.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Tangen', 'Affiliation': 'Statistics and Data Management Center at Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Plets', 'Affiliation': 'Statistics and Data Management Center at Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Gareth J', 'Initials': 'GJ', 'LastName': 'Morrison', 'Affiliation': 'University of Southern California Norris Comprehensive Cancer Center and Keck School of Medicine, Los Angeles, California.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Cunha', 'Affiliation': 'University of Southern California Norris Comprehensive Cancer Center and Keck School of Medicine, Los Angeles, California.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'University of Southern California Norris Comprehensive Cancer Center and Keck School of Medicine, Los Angeles, California.'}, {'ForeName': 'Jacek K', 'Initials': 'JK', 'LastName': 'Pinski', 'Affiliation': 'University of Southern California Norris Comprehensive Cancer Center and Keck School of Medicine, Los Angeles, California.'}, {'ForeName': 'Sue A', 'Initials': 'SA', 'LastName': 'Ingles', 'Affiliation': 'University of Southern California Norris Comprehensive Cancer Center and Keck School of Medicine, Los Angeles, California.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Triche', 'Affiliation': 'University of Southern California Norris Comprehensive Cancer Center and Keck School of Medicine, Los Angeles, California.'}, {'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Harzstark', 'Affiliation': 'Kaiser Permanente-Oakland, Oakland, California.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Kohli', 'Affiliation': 'University of Utah Huntsman Cancer Institute, Salt Lake City, Utah.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'MacVicar', 'Affiliation': 'Illinois Cancer Care/Heartland NCORP, Peoria, Illinois.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Vaena', 'Affiliation': 'West Cancer Center and Research Institute, Germantown, Tennessee, and University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Anthony W', 'Initials': 'AW', 'LastName': 'Crispino', 'Affiliation': 'UsTOO Las Vegas, Las Vegas, Nevada.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'McConkey', 'Affiliation': 'Johns Hopkins Greenberg Bladder Cancer Institute, Baltimore, Maryland.'}, {'ForeName': 'Primo N', 'Initials': 'PN', 'LastName': 'Lara', 'Affiliation': 'UC Davis Comprehensive Cancer Center, Sacramento, California.'}, {'ForeName': 'Maha H A', 'Initials': 'MHA', 'LastName': 'Hussain', 'Affiliation': 'Northwestern University, Chicago, Illinois.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Quinn', 'Affiliation': 'University of Southern California Norris Comprehensive Cancer Center and Keck School of Medicine, Los Angeles, California.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Vogelzang', 'Affiliation': 'Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada.'}, {'ForeName': 'Ian Murchie', 'Initials': 'IM', 'LastName': 'Thompson', 'Affiliation': 'Christus Santa Rosa Hospital-Medical Center, San Antonio, Texas.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Agarwal', 'Affiliation': 'University of Utah Huntsman Cancer Institute, Salt Lake City, Utah.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-3587'] 1998,33497912,Longitudinal impact and effects of booster sessions in a cognitive training program for healthy older adults.,"This paper reports the results from a 3-year follow-up study to measure the long-term efficacy of a cognitive training for healthy older adults and investigates the effects of booster sessions using an entropy-based metric. DESIGN semi-randomized quasi-experimental controlled design. PARTICIPANTS 50 older adults, (M = 73.3, SD = 7.77) assigned into experimental (N = 25; Mean age = 73.9; SD = 8.62) and control groups (N = 25; mean age = 72.9; SD = 6.97). INSTRUMENTS six subtests of WAIS and two episodic memory tasks. PROCEDURES the participants were assessed on four occasions: after the end of the original intervention, pre-booster sessions (three years after the original intervention), immediately after the booster sessions and three months after the booster sessions. RESULTS the repeated measures ANOVA showed that two of the cognitive gains reported in the original intervention were also identified in the follow-up: Coding (F(1, 44) = 11.79, MSE = 0.77, p = .001, eta squared = 0.084) and Picture Completion (F(1, 47) = 10.01, MSE = 0.73, p = .003, eta squared = 0.060). After the booster sessions, all variables presented a significant interaction between group and time favorable to the experimental group (moderate to high effect sizes). To compare the level of cohesion of the cognitive variables between the groups, an entropy-based metric was used. The experimental group presented a lower level of cohesion on three of the four measurement occasions, suggesting a differential impact of the intervention with immediate and short-term effects, but without long-term effects.",2021,"Coding (F(1, 44) = 11.79, MSE = 0.77, p = .001, eta squared = 0.084) and Picture Completion (F(1, 47) = 10.01, MSE = ","['50 older adults, (M\xa0=\xa073.3, SD\xa0=\xa07.77) assigned into experimental (N\xa0', 'healthy older adults', '25; Mean age\xa0=\xa073.9; SD\xa0=\xa08.62) and control groups (N\xa0=\xa025; mean age\xa0']","['cognitive training', 'cognitive training program', 'booster sessions']",['cognitive gains'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}]",[],50.0,0.0388754,"Coding (F(1, 44) = 11.79, MSE = 0.77, p = .001, eta squared = 0.084) and Picture Completion (F(1, 47) = 10.01, MSE = ","[{'ForeName': 'Lucas Matias', 'Initials': 'LM', 'LastName': 'Felix', 'Affiliation': 'Universidade Federal de Minas Gerais, Department of Psychology: 6627 Antonio Carlos avenue, Belo Horizonte, Minas Gerais, 31270-901, Brazil.'}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Mansur-Alves', 'Affiliation': 'Universidade Federal de Minas Gerais, Department of Psychology: 6627 Antonio Carlos avenue, Belo Horizonte, Minas Gerais, 31270-901, Brazil.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Teles', 'Affiliation': 'University of Virginia, Deparment of Psychology: 485, McCormick Road, Gilmer Hall, Charlottesville, VA 22903, U.S.. Electronic address: mt2yq@virginia.edu.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Jamison', 'Affiliation': 'University of Virginia, Deparment of Psychology: 485, McCormick Road, Gilmer Hall, Charlottesville, VA 22903, U.S.'}, {'ForeName': 'Hudson', 'Initials': 'H', 'LastName': 'Golino', 'Affiliation': 'University of Virginia, Deparment of Psychology: 485, McCormick Road, Gilmer Hall, Charlottesville, VA 22903, U.S.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2021.104337'] 1999,29927884,"Hormonal Contraceptive Use Does Not Affect Strength, Endurance, or Body Composition Adaptations to Combined Strength and Endurance Training in Women.","ABSTRACT Myllyaho, MM, Ihalainen, JK, Hackney, AC, Valtonen, M, Nummela, A, Vaara, E, Häkkinen, K, Kyröläinen, H, and Taipale, RS. Hormonal contraceptive use does not affect strength, endurance, or body composition adaptations to combined strength and endurance training in women. J Strength Cond Res 35(2): 449-457, 2021-This study examined the effects of a 10-week period of high-intensity combined strength and endurance training on strength, endurance, body composition, and serum hormone concentrations in physically active women using hormonal contraceptives (HCs, n = 9) compared with those who had never used hormonal contraceptives (NHCs, n = 9). Training consisted of 2 strength training sessions and 2 high-intensity running interval sessions per week. Maximal bilateral isometric leg press (Isom), maximal bilateral dynamic leg press (one repetition maximum [1RM]), countermovement jump (CMJ), a 3,000-m running test (3,000 m), body composition, and serum hormone levels were measured before and after training between days 1-5 of each subject's menstrual cycle. Both groups increased 1RM and CMJ: HC = 13.2% (p < 0.001) and 9.6% (p < 0.05), and NHC = 8.3% (p < 0.01) and 8.5% (p < 0.001). Hormonal contraceptive improved 3,000 m by 3.5% (p < 0.05) and NHC by 1% (n.s.). Never used hormonal contraceptive increased lean mass by 2.1% (p < 0.001), whereas body fat percentage decreased from 23.9 ± 6.7 to 22.4 ± 6.0 (-6.0%, p < 0.05). No significant changes were observed in body composition in HC. No significant between-group differences were observed in any of the performance variables. Luteinizing hormone concentrations decreased significantly (p < 0.05) over 10 weeks in NHC, whereas other hormone levels remained statistically unaltered in both groups. It seems that the present training is equally appropriate for improving strength, endurance, and body composition in women using HC as those not using HC without disrupting hypothalamic-pituitary-gonadal axis function.",2021,"Both groups increased 1RM and CMJ: HC = 13.2% (p < 0.001) and 9.6% (p < 0.05), and NHC = 8.3% (p < 0.01) and 8.5% (p < 0.001).","['women', 'J Strength Cond Res 35(2', 'Women', 'physically active women using hormonal contraceptives (HCs, n = 9) compared with those who had never used hormonal contraceptives (NHCs, n = 9']",['high-intensity combined strength and endurance training'],"['body composition in HC', 'body fat percentage', 'hormone levels', 'Strength, Endurance, or Body Composition Adaptations', 'Maximal bilateral isometric leg press (Isom), maximal bilateral dynamic leg press (one repetition maximum [1RM]), countermovement jump (CMJ), a 3,000-m running test (3,000 m), body composition, and serum hormone levels', 'Luteinizing hormone concentrations', 'strength, endurance, and body composition', 'Hormonal contraceptive', 'strength, endurance, or body composition adaptations', 'lean mass', 'strength, endurance, body composition, and serum hormone concentrations']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0032052', 'cui_str': 'Human placental lactogen'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",,0.0138398,"Both groups increased 1RM and CMJ: HC = 13.2% (p < 0.001) and 9.6% (p < 0.05), and NHC = 8.3% (p < 0.01) and 8.5% (p < 0.001).","[{'ForeName': 'Moona M', 'Initials': 'MM', 'LastName': 'Myllyaho', 'Affiliation': 'Biology of Physical Activity, Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Johanna K', 'Initials': 'JK', 'LastName': 'Ihalainen', 'Affiliation': 'Biology of Physical Activity, Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Hackney', 'Affiliation': 'Department of Exercise & Sport Science, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Maarit', 'Initials': 'M', 'LastName': 'Valtonen', 'Affiliation': 'Research Institute for Olympic Sport, Jyväskylä, Finland.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Nummela', 'Affiliation': 'Research Institute for Olympic Sport, Jyväskylä, Finland.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Vaara', 'Affiliation': 'JAMK University of Applied Sciences, Jyväskylä, Finland; and.'}, {'ForeName': 'Keijo', 'Initials': 'K', 'LastName': 'Häkkinen', 'Affiliation': 'Biology of Physical Activity, Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Kyröläinen', 'Affiliation': 'Biology of Physical Activity, Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Ritva S', 'Initials': 'RS', 'LastName': 'Taipale', 'Affiliation': 'Kajaani University of Applied Sciences, Kajaani, Finland.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002713'] 2000,33504677,Promoting physical activity among physically inactive people with impaired glucose tolerance and/or impaired fasting glucose: a clustered randomised controlled trial (abridged secondary publication).,,2020,,['physically inactive people with impaired glucose tolerance and/or impaired fasting glucose'],[],[],"[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",[],[],,0.117932,,"[{'ForeName': 'J T F', 'Initials': 'JTF', 'LastName': 'Lau', 'Affiliation': 'School of Public Health and Primary Care, The Chinese University of Hong Kong.'}, {'ForeName': 'J C N', 'Initials': 'JCN', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong.'}, {'ForeName': 'S O L', 'Initials': 'SOL', 'LastName': 'Pong', 'Affiliation': 'Shatin District Council.'}, {'ForeName': 'H H Y', 'Initials': 'HHY', 'LastName': 'Chung', 'Affiliation': 'Yao Chung Kit Diabetes Assessment Centre, The Chinese University of Hong Kong.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ozaki', 'Affiliation': 'Division of Diabetes and Endocrinology, The Chinese University of Hong Kong.'}, {'ForeName': 'M C S', 'Initials': 'MCS', 'LastName': 'Wong', 'Affiliation': 'School of Public Health and Primary Care, The Chinese University of Hong Kong.'}, {'ForeName': 'E F L', 'Initials': 'EFL', 'LastName': 'Leung', 'Affiliation': 'Physical Education Unit, The Chinese University of Hong Kong.'}, {'ForeName': 'L W H', 'Initials': 'LWH', 'LastName': 'Mui', 'Affiliation': 'School of Public Health and Primary Care, The Chinese University of Hong Kong.'}, {'ForeName': 'K C', 'Initials': 'KC', 'LastName': 'Choi', 'Affiliation': 'The Nethersole School of Nursing, The Chinese University of Hong Kong.'}]",Hong Kong medical journal = Xianggang yi xue za zhi,[] 2001,33504673,Fast-track versus traditional perioperative care for laparoscopic colorectal surgery: a prospective randomised trial (abridged secondary publication).,,2020,,['laparoscopic colorectal surgery'],['Fast-track versus traditional perioperative care'],[],"[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0150706', 'cui_str': 'Perioperative care'}]",[],,0.0545451,,"[{'ForeName': 'S S M', 'Initials': 'SSM', 'LastName': 'Ng', 'Affiliation': 'Department of Surgery, The Chinese University of Hong Kong.'}, {'ForeName': 'S K C', 'Initials': 'SKC', 'LastName': 'Chan', 'Affiliation': 'Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong.'}, {'ForeName': 'M H L', 'Initials': 'MHL', 'LastName': 'Ng', 'Affiliation': 'Department of Anatomical and Cellular Pathology, The Chinese University of Hong Kong.'}, {'ForeName': 'J F Y', 'Initials': 'JFY', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, The Chinese University of Hong Kong.'}, {'ForeName': 'P B S', 'Initials': 'PBS', 'LastName': 'Lai', 'Affiliation': 'Department of Surgery, The Chinese University of Hong Kong.'}]",Hong Kong medical journal = Xianggang yi xue za zhi,[] 2002,33504670,Purpose-built intervention for mental health of Mainland Chinese immigrant women survivors of intimate partner violence: a randomised controlled trial (abridged secondary publication).,,2020,,['mental health of Mainland Chinese immigrant women survivors of intimate partner violence'],[],[],"[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0282163', 'cui_str': 'Immigrant'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]",[],[],,0.21853,,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tiwari', 'Affiliation': 'School of Nursing, The University of Hong Kong.'}, {'ForeName': 'D Y T', 'Initials': 'DYT', 'LastName': 'Fong', 'Affiliation': 'School of Nursing, The University of Hong Kong.'}, {'ForeName': 'F K H', 'Initials': 'FKH', 'LastName': 'Yuen', 'Affiliation': 'School of Nursing, The University of Hong Kong.'}, {'ForeName': 'H Y K', 'Initials': 'HYK', 'LastName': 'Fung', 'Affiliation': 'H.K.S.K.H. Lady MacLehose Centre.'}, {'ForeName': 'P O Y', 'Initials': 'POY', 'LastName': 'Pang', 'Affiliation': 'H.K.S.K.H. Lady MacLehose Centre.'}, {'ForeName': 'J Y H', 'Initials': 'JYH', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, The University of Hong Kong.'}]",Hong Kong medical journal = Xianggang yi xue za zhi,[] 2003,33503629,Cost-Effectiveness and Cost-Utility of a Home-Based Exercise Program in Geriatric Patients with Cognitive Impairment.,"INTRODUCTION There is a substantial lack of home-based exercise programs in the highly vulnerable group of geriatric patients with cognitive impairment (CI) after discharge from ward rehabilitation. Beyond clinical effectiveness, the cost-effectiveness of intervention programs to enhance physical performance is not well investigated in this target group. OBJECTIVE The aim of the study was to determine the cost-effectiveness of a 12-week home-based exercise intervention following discharge from ward rehabilitation compared to unspecified flexibility training for geriatric patients with CI from a societal perspective. METHODS This cost-effectiveness study was conducted alongside a randomized placebo-controlled trial. A total of 118 geriatric patients with CI (Mini-Mental State Examination score: 17-26) were randomized either to the intervention group (IG, n = 63) or control group (CG, n = 55). Participants in the IG received a home-based individually tailored exercise program to increase physical performance, while participants in the CG received unspecific flexibility training (placebo control). Healthcare service use, physical performance (Short Physical Performance Battery, SPPB), and quality of life (EQ-5D-3L) were measured over 24 weeks. The net monetary benefit (NMB) approach was applied to calculate incremental cost-effectiveness of the exercise intervention compared to the CG with respect to improvement of (a) physical performance on the SPPB and (b) quality-adjusted life years (QALYs). RESULTS Physical performance was significantly improved in the IG compared to the CG (mean difference at 24 weeks: 1.3 points; 95% confidence interval [95% CI] = 0.5-2.2; p = 0.003), while health-related quality of life did not significantly differ between the groups at 24 weeks (mean difference: 0.08; 95% CI = -0.05 to 0.21; p = 0.218). Mean costs to implement the home-based exercise intervention were EUR 284 per patient. The probability of a positive incremental NMB of the intervention reached a maximum of 92% at a willingness to pay (WTP) of EUR 500 per point on the SPPB. The probability of cost-utility referring to QALYs was 85% at a WTP of EUR 5,000 per QALY. CONCLUSION The home-based exercise intervention demonstrated high probability of cost-effectiveness in terms of improved physical performance in older adults with CI following discharge from ward rehabilitation, but not in terms of quality of life.",2021,"The home-based exercise intervention demonstrated high probability of cost-effectiveness in terms of improved physical performance in older adults with CI following discharge from ward rehabilitation, but not in terms of quality of life.","['geriatric patients with CI from a societal perspective', 'older adults with CI following discharge from ward rehabilitation', '118 geriatric patients with CI (Mini-Mental State Examination score: 17-26', 'geriatric patients with cognitive impairment (CI) after discharge from ward rehabilitation', 'Geriatric Patients with Cognitive Impairment']","['home-based individually tailored exercise program', 'exercise intervention', 'Home-Based Exercise Program', 'placebo', 'unspecific flexibility training (placebo control', 'unspecified flexibility training', 'home-based exercise intervention']","['Physical performance', 'cost-effectiveness', 'SPPB and (b) quality-adjusted life years (QALYs', 'probability of cost-utility referring to QALYs', 'physical performance', 'Mean costs', 'health-related quality of life', 'Cost-Effectiveness and Cost-Utility', 'Healthcare service use, physical performance (Short Physical Performance Battery, SPPB), and quality of life (EQ-5D-3L']","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0584528', 'cui_str': 'Discharge from ward'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0557829', 'cui_str': 'Healthcare services'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}]",118.0,0.0719326,"The home-based exercise intervention demonstrated high probability of cost-effectiveness in terms of improved physical performance in older adults with CI following discharge from ward rehabilitation, but not in terms of quality of life.","[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Eckert', 'Affiliation': 'Department of Geriatric Research, AGAPLESION Bethanien Hospital Heidelberg/Geriatric Centre of the University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Wronski', 'Affiliation': 'Department for General Practice and Health Services Research, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bongartz', 'Affiliation': 'Department of Geriatric Research, AGAPLESION Bethanien Hospital Heidelberg/Geriatric Centre of the University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Phoebe', 'Initials': 'P', 'LastName': 'Ullrich', 'Affiliation': 'Department of Geriatric Research, AGAPLESION Bethanien Hospital Heidelberg/Geriatric Centre of the University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'Abel', 'Affiliation': 'Department of Geriatric Research, AGAPLESION Bethanien Hospital Heidelberg/Geriatric Centre of the University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Kiss', 'Affiliation': 'Department of Health and Social Affairs, FHM Bielefeld, University of Applied Sciences, Bielefeld, Germany.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Wensing', 'Affiliation': 'Department for General Practice and Health Services Research, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Koetsenruijter', 'Affiliation': 'Department for General Practice and Health Services Research, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Hauer', 'Affiliation': 'Department of Geriatric Research, AGAPLESION Bethanien Hospital Heidelberg/Geriatric Centre of the University of Heidelberg, Heidelberg, Germany, khauer@bethanien-heidelberg.de.'}]",Gerontology,['10.1159/000512748'] 2004,33507500,Benefit of Early Add-on of Linagliptin to Insulin in Japanese Patients With Type 2 Diabetes Mellitus: Randomized-Controlled Open-Label Trial (TRUST2).,"INTRODUCTION This trial was conducted to assess the long-term safety, efficacy, and benefit of early add-on of linagliptin to insulin in patients with type 2 diabetes mellitus (T2DM). METHODS This trial enrolled 246 subjects. The subjects were randomized to the linagliptin group or the control group and were observed for 156 weeks. After week 16, subjects in the control group were also allowed to add linagliptin to evaluate the benefit of early add-on of linagliptin to insulin. The primary end point was a change in HbA1c from baseline to week 16. Secondary end points included fasting plasma glucose, daily insulin dose, and frequency of adverse events. RESULTS HbA1c and fasting plasma glucose levels significantly decreased from baseline to week 16 in the linagliptin group compared with the control group. The significant improvement in HbA1c continued until week 52. The daily insulin dose significantly decreased in the linagliptin group compared with the control group. The frequency of hypoglycemia and adverse events was comparable in both groups. CONCLUSIONS Add-on of linagliptin to insulin was tolerated, improved glycemic control, and reduced the daily insulin dose. This study demonstrates the long-term safety, efficacy and benefit of early add-on of linagliptin to insulin in Japanese T2DM patients.",2021,"RESULTS HbA1c and fasting plasma glucose levels significantly decreased from baseline to week 16 in the linagliptin group compared with the control group.","['Japanese T2DM patients', '246 subjects', 'patients with type 2 diabetes mellitus (T2DM', 'Japanese Patients With Type 2 Diabetes Mellitus']","['Linagliptin', 'linagliptin', 'linagliptin to insulin']","['change in HbA1c', 'frequency of hypoglycemia and adverse events', 'tolerated, improved glycemic control', 'daily insulin dose', 'HbA1c and fasting plasma glucose levels', 'fasting plasma glucose, daily insulin dose, and frequency of adverse events']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",246.0,0.0422634,"RESULTS HbA1c and fasting plasma glucose levels significantly decreased from baseline to week 16 in the linagliptin group compared with the control group.","[{'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Katsuno', 'Affiliation': 'Division of Diabetes, Endocrinology and Clinical Immunology, Department of Internal Medicine, Hyogo College of Medicine, Hyogo, Japan. katsunoa@huhs.ac.jp.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Shiraiwa', 'Affiliation': 'Shiraiwa Medical Clinic, Osaka, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Iwasaki', 'Affiliation': 'Iwasaki Internal Medicine Clinic, Osaka, Japan.'}, {'ForeName': 'Hyohun', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Fukuda Clinic, Osaka, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Watanabe', 'Affiliation': 'Watanabe Clinic, Hyogo, Japan.'}, {'ForeName': 'Shizuka', 'Initials': 'S', 'LastName': 'Kaneko', 'Affiliation': 'Takatsuki Red Cross Hospital, Osaka, Japan.'}, {'ForeName': 'Jungo', 'Initials': 'J', 'LastName': 'Terasaki', 'Affiliation': 'Department of Internal Medicine (I), Osaka Medical College, Takatsuki, Osaka, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Hanafusa', 'Affiliation': 'Sakai City Medical Center, Osaka, Japan.'}, {'ForeName': 'Akihisa', 'Initials': 'A', 'LastName': 'Imagawa', 'Affiliation': 'Department of Internal Medicine (I), Osaka Medical College, Takatsuki, Osaka, Japan.'}, {'ForeName': 'Iichiro', 'Initials': 'I', 'LastName': 'Shimomura', 'Affiliation': 'Department of Metabolic Medicine, Graduate School of Medicine, Osaka University, Osaka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ikegami', 'Affiliation': 'Department of Endocrinology, Metabolism and Diabetes, Kindai University, Osaka, Japan.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Koyama', 'Affiliation': 'Division of Diabetes, Endocrinology and Clinical Immunology, Department of Internal Medicine, Hyogo College of Medicine, Hyogo, Japan.'}, {'ForeName': 'Mitsuyoshi', 'Initials': 'M', 'LastName': 'Namba', 'Affiliation': 'Division of Diabetes, Endocrinology and Clinical Immunology, Department of Internal Medicine, Hyogo College of Medicine, Hyogo, Japan.'}, {'ForeName': 'Jun-Ichiro', 'Initials': 'JI', 'LastName': 'Miyagawa', 'Affiliation': 'Division of Diabetes, Endocrinology and Clinical Immunology, Department of Internal Medicine, Hyogo College of Medicine, Hyogo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Advances in therapy,['10.1007/s12325-021-01631-y'] 2005,33507924,Gamifying quantitative face-to-face interviews in rural India: An empirical evaluation based on the basic psychological needs theory.,"OBJECTIVE Standardized face-to-face interviews are widely used in low and middle-income countries to collect data for social science and health research. Such interviews can be long and tedious. In an attempt to improve the respondents' experience of interviews, we developed a concept of gamified interview format by including a game element. Gamification is reported to increase engagement in tasks, but results from rigorously developed research are equivocal, and a theory of gamification is still needed. MATERIALS & METHODS We evaluated the proposed gamification with a randomized controlled trial based on self-determination theory, specifically on the basic psychological needs theory. In total, 1266 respondents were interviewed. Single and multiple mediation analyses were used to understand the effects of the gamified interview format. RESULTS Our evaluation showed that the gamification we had developed did not improve the outcome, the experience of the interview reported by respondent. The effect of the gamified interview format depended on the ability of respondents: gamification can be counterproductive if it overburdens the respondents. However, the basic psychological needs theory explained the mechanisms of action of gamification well: feeling competent and related to others improved the reported experience of the interview. CONCLUSION We emphasize the need to develop context-specific gamification and invite researchers to conduct equivalently rigorous evaluations of gamification in future studies.",2021,"Our evaluation showed that the gamification we had developed did not improve the outcome, the experience of the interview reported by respondent.","['rural India', 'In total, 1266 respondents were interviewed']",[],[],"[{'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]",[],[],1266.0,0.0266401,"Our evaluation showed that the gamification we had developed did not improve the outcome, the experience of the interview reported by respondent.","[{'ForeName': 'Alice H', 'Initials': 'AH', 'LastName': 'Aubert', 'Affiliation': 'Eawag: Swiss Federal Institute of Aquatic Science and Technology, Dübendorf, Switzerland.'}, {'ForeName': 'Max N D', 'Initials': 'MND', 'LastName': 'Friedrich', 'Affiliation': 'Eawag: Swiss Federal Institute of Aquatic Science and Technology, Dübendorf, Switzerland.'}]",PloS one,['10.1371/journal.pone.0244077'] 2006,33512318,Factors Associated With Dropout of Participants in an App-Based Child Injury Prevention Study: Secondary Data Analysis of a Cluster Randomized Controlled Trial.,"BACKGROUND Mobile health (mHealth) interventions offer great potential to reach large populations and improve public health. However, high attrition rates threaten evaluation and implementation of mHealth intervention studies. OBJECTIVE We explored factors associated with attrition of study participants in an mHealth randomized controlled trial (RCT) evaluating an intervention to reduce unintentional child injury risk in China. METHODS The cluster RCT compared two groups of an app-based intervention for caregivers of 3-6-year-old children (Bao Hu San). The intervention group received unintentional child injury and parenting education, whereas only parenting education was implemented in the control group. The trial included 2920 study participants in Changsha, China, and lasted 6 months. Data on participant engagement (using the app) were collected electronically throughout the 6-month period. Associations between participant attrition and demographic characteristics, and between attrition and intervention engagement were tested and quantified separately for the intervention and control groups using the adjusted odds ratio (aOR) based on generalized linear mixed models. RESULTS In total, 2920 caregivers from 20 eligible preschools participated, with 1510 in the intervention group and 1410 in the control group. The 6-month attrition rate differed significantly between the two groups (P<.001), at 28.9% (437/1510) in the intervention group and 35.7% (503/1410) in the control group. For the intervention group, the only significant predictor of attrition risk was participants who learned fewer knowledge segments (aOR 2.69, 95% CI 1.19-6.09). For the control group, significant predictors of attrition risk were lower monthly login frequency (aOR 1.48, 95% CI 1.00-2.18), learning fewer knowledge segments (aOR 1.70, 95% CI 1.02-2.81), and shorter learning durations during app engagement (aOR 2.39, 95% CI 1.11-5.15). Demographic characteristics were unrelated to attrition. CONCLUSIONS Engagement in the app intervention was associated with participant attrition. Researchers and practitioners should consider how to best engage participants in app-based interventions to reduce attrition. TRIAL REGISTRATION Chinese Clinical Trial Registry ChiCTR-IOR-17010438; http://www.chictr.org.cn/showproj.aspx?proj=17376. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) RR2-10.1186/s12889-018-5790-1.",2021,The cluster RCT compared two groups of an app-based intervention for caregivers of 3-6-year-old children (Bao Hu San).,"['2920 study participants in Changsha, China, and lasted 6 months', '2920 caregivers from 20 eligible preschools participated, with 1510 in the intervention group and 1410 in the control group', 'unintentional child injury risk in China']",['unintentional child injury and parenting education'],"['learning fewer knowledge segments', '6-month attrition rate', 'shorter learning durations', 'attrition risk']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1283932', 'cui_str': 'Unintentional'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0582456', 'cui_str': 'At risk for injury'}]","[{'cui': 'C1283932', 'cui_str': 'Unintentional'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0242261', 'cui_str': 'Parenting education'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",2920.0,0.142239,The cluster RCT compared two groups of an app-based intervention for caregivers of 3-6-year-old children (Bao Hu San).,"[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology and Health Statistics, Xiangya School of Public Health, Central South University, Changsha, China.'}, {'ForeName': 'Peishan', 'Initials': 'P', 'LastName': 'Ning', 'Affiliation': 'Department of Epidemiology and Health Statistics, Xiangya School of Public Health, Central South University, Changsha, China.'}, {'ForeName': 'Peixia', 'Initials': 'P', 'LastName': 'Cheng', 'Affiliation': 'Department of Epidemiology and Health Statistics, Xiangya School of Public Health, Central South University, Changsha, China.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Schwebel', 'Affiliation': 'Department of Psychology, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Biostatistics, College of Public Health and Health Professions, Emerging Pathogen Institute, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'Department of Epidemiology and Health Statistics, Xiangya School of Public Health, Central South University, Changsha, China.'}, {'ForeName': 'Jieyi', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Epidemiology and Health Statistics, Xiangya School of Public Health, Central South University, Changsha, China.'}, {'ForeName': 'Wanhui', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology and Health Statistics, Xiangya School of Public Health, Central South University, Changsha, China.'}, {'ForeName': 'Ruotong', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology and Health Statistics, Xiangya School of Public Health, Central South University, Changsha, China.'}, {'ForeName': 'Guoqing', 'Initials': 'G', 'LastName': 'Hu', 'Affiliation': 'Department of Epidemiology and Health Statistics, Xiangya School of Public Health, Central South University, Changsha, China.'}]",Journal of medical Internet research,['10.2196/21636'] 2007,33523583,"Caregiver-Oncologist Prognostic Concordance, Caregiver Mastery, and Caregiver Psychological Health and Quality of Life.","BACKGROUND Caregivers of adults with cancer often report a different understanding of the patient's prognosis than the oncologist. We examine the associations of caregiver-oncologist prognostic concordance with caregiver depressive symptoms, distress, and quality of life (QoL). We also explore whether these relationships differed by caregiver environment mastery, an individual's sense of control, and effectiveness in managing life situations. MATERIALS AND METHODS We used data from a national geriatric assessment cluster-randomized trial (URCC 13070) that recruited patients aged 70 years and older with incurable cancer considering any line of cancer treatment at community oncology practices, their caregivers, and their oncologists. At enrollment, caregivers and oncologists estimated the patient's prognosis (0-6 months, 7-12 months, 1-2 years, 2-5 years, and >5 years; identical responses were concordant). Caregivers completed the Ryff's environmental mastery at enrollment. At 4-6 weeks, caregivers completed the Patient Health Questionnaire-2 (depressive symptoms), distress thermometer, and 12-Item Short-Form Health Survey (quality of life [QoL]). We used generalized estimating equations in models adjusted for covariates. We then assessed the moderation effect of caregiver mastery. RESULTS Of 411 caregiver-oncologist dyads (mean age = 66.5 years), 369 provided responses and 28% were concordant. Prognostic concordance was associated with greater caregiver depressive symptoms (β = 0.30; p = .04) but not distress or QoL. A significant moderation effect for caregiver depressive symptoms was found between concordance and mastery (p = .01). Specifically, among caregivers with low mastery (below median), concordance was associated with greater depressive symptoms (β = 0.68; p = .003). CONCLUSIONS Caregiver-oncologist prognostic concordance was associated with caregiver depressive symptoms. We found a novel moderating effect of caregiver mastery on the relationship between concordance and caregiver depressive symptoms. IMPLICATIONS FOR PRACTICE Caregiver-oncologist prognostic concordance is associated with greater caregiver depressive symptoms, particularly in those with low caregiver mastery. When discussing prognosis with caregivers, physicians should be aware that prognostic understanding may affect caregiver psychological health and should assess their depressive symptoms. In addition, while promoting accurate prognostic understanding, physicians should also identify strengths and build resilience among caregivers.",2021,A significant moderation effect for caregiver depressive symptoms was found between concordance and mastery (p=0.01).,"['patients aged ≥70 with incurable cancer considering any line of cancer treatment at community oncology practices, their caregivers, and their oncologists', 'Caregivers of adults with cancer', 'Of 411 caregiver-oncologist dyads (meanage=66.5']",[],"['Caregiver-oncologist prognostic concordance, caregiver mastery, and caregiver psychological health and quality of life', 'caregiver depressive symptoms, distress, and quality of life (QoL', 'caregiver depressive symptoms', 'depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",,0.214725,A significant moderation effect for caregiver depressive symptoms was found between concordance and mastery (p=0.01).,"[{'ForeName': 'Kah Poh', 'Initials': 'KP', 'LastName': 'Loh', 'Affiliation': 'James P Wilmot Cancer Institute, Division of Hematology/Oncology, Department of Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.'}, {'ForeName': 'Mostafa R', 'Initials': 'MR', 'LastName': 'Mohamed', 'Affiliation': 'James P Wilmot Cancer Institute, Division of Hematology/Oncology, Department of Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.'}, {'ForeName': 'Sindhuja', 'Initials': 'S', 'LastName': 'Kadambi', 'Affiliation': 'James P Wilmot Cancer Institute, Division of Hematology/Oncology, Department of Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Culakova', 'Affiliation': 'Department\u2009of Surgery, Cancer Control, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.'}, {'ForeName': 'Huiwen', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department\u2009of Surgery, Cancer Control, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Magnuson', 'Affiliation': 'James P Wilmot Cancer Institute, Division of Hematology/Oncology, Department of Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Flannery', 'Affiliation': 'School of Nursing, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Duberstein', 'Affiliation': 'Department of Health Behavior, Society, and Policy, Rutgers School of Public Health, Piscataway, New Jersey, USA.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Epstein', 'Affiliation': 'James P Wilmot Cancer Institute, Division of Hematology/Oncology, Department of Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'McHugh', 'Affiliation': 'James P Wilmot Cancer Institute, Division of Hematology/Oncology, Department of Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.'}, {'ForeName': 'Ryan D', 'Initials': 'RD', 'LastName': 'Nipp', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Trevino', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Chandrika', 'Initials': 'C', 'LastName': 'Sanapala', 'Affiliation': 'James P Wilmot Cancer Institute, Division of Hematology/Oncology, Department of Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.'}, {'ForeName': 'Bianca A', 'Initials': 'BA', 'LastName': 'Hall', 'Affiliation': 'James P Wilmot Cancer Institute, Division of Hematology/Oncology, Department of Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Canin', 'Affiliation': 'SCOREboard Advisory Group, University of Rochester Medical Center, Rochester, New York, USA.'}, {'ForeName': 'Arlene A', 'Initials': 'AA', 'LastName': 'Gayle', 'Affiliation': 'Wisconsin National Cancer Institute (NCI) Community Oncology Research Program, Wisconsin, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Conlin', 'Affiliation': 'Pacific Cancer Research Consortium NCI Community Oncology Research Program, Washington, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Bearden', 'Affiliation': 'Southeast Clinical Oncology Research Consortium, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Supriya G', 'Initials': 'SG', 'LastName': 'Mohile', 'Affiliation': 'James P Wilmot Cancer Institute, Division of Hematology/Oncology, Department of Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.'}]",The oncologist,['10.1002/onco.13699'] 2008,33524060,"Sustained functional benefits after a single set of injections with abobotulinumtoxinA using a 2-mL injection volume in adults with cervical dystonia: 12-week results from a randomized, double-blind, placebo-controlled phase 3b study.","Cervical dystonia (CD) is primarily treated with botulinum toxin, at intervals of ≥ 12 weeks. We present efficacy, patient-reported outcomes (PROs), and safety in adults with CD at the last available visit after a single set of abobotulinumtoxinA (aboBoNT-A) injections versus placebo using 500 U in a 2-mL injection volume. In this 12-week, randomized, double-blind trial, patients were ≥ 18 years of age with primary idiopathic CD, had a Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score ≥ 20, and TWSTRS-Severity subscale score > 10 at baseline. Patients (N = 134) were randomized (2:1) to aboBoNT-A (n = 89) or placebo (n = 45), with aboBoNT-A patients treated with 500 units (U) if toxin-naïve, and 250 to 500 U based on previous onabotulinumtoxinA dose if non-naïve. Endpoints included total TWSTRS, Pain Numeric Rating Scale (NRS-Pain; 24-hour), Treatment Satisfaction Questionnaire for Medication, and other PROs for pain, depression, and global health. Results are for the intent-to-treat population, with ""Week 12"" (Wk12) comprising the last available post-baseline assessment (end-of-study or early withdrawal). Mean TWSTRS total scores improved from 42.5 at baseline to 35.4 at Wk12 with aboBoNT-A and 42.4 to 40.4 with placebo (treatment difference: -4.8; 95% confidence interval [CI]: -8.5, -1.1; p = 0.011). At Wk12, mean (95% CI) change from baseline in NRS-Pain was -1.0 (-1.59, -0.45) for aboBoNT-A and -0.2 (-0.96, 0.65) for placebo. AboBoNT-A demonstrated numeric improvements in other PROs. More aboBoNT-A-treated patients than patients receiving placebo reported being at least ""somewhat satisfied"" with treatment (60.4% vs 42.2%, respectively), symptom relief (57.0% vs 40.0%), and time for treatment to work (55.8% vs 33.3%). No new adverse events were reported. Results indicate that in patients with CD, treatment with aboBoNT-A using a 2-mL injection provided sustained improvement in the TWSTRS total score and patient-perceived benefits up to 12 weeks. Trial registration: Clinicaltrials.gov Identified: NCT01753310.",2021,"Mean TWSTRS total scores improved from 42.5 at baseline to 35.4 at Wk12 with aboBoNT-A and 42.4 to 40.4 with placebo (treatment difference: -4.8; 95% confidence interval [CI]: -8.5, -1.1; p = 0.011).","['patients were ≥ 18 years of age with primary idiopathic CD, had a Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score ≥ 20, and TWSTRS-Severity subscale score > 10 at baseline', 'adults with CD at the last available visit after a single set of', 'adults with cervical dystonia', 'Patients (N = 134']","['placebo', 'aboBoNT-A patients treated with 500 units (U) if toxin-naïve, and 250 to 500 U based on previous onabotulinumtoxinA dose if non-naïve', 'abobotulinumtoxinA (aboBoNT-A) injections versus placebo', 'botulinum toxin', 'abobotulinumtoxinA']","['Mean TWSTRS total scores', 'Cervical dystonia (CD', 'total TWSTRS, Pain Numeric Rating Scale (NRS-Pain; 24-hour), Treatment Satisfaction Questionnaire for Medication, and other PROs for pain, depression, and global health', 'NRS-Pain', 'symptom relief']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0949445', 'cui_str': 'Cervical Dystonia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C4517565', 'cui_str': '134'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2719424', 'cui_str': 'AbobotulinumtoxinA'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0040549', 'cui_str': 'Toxin'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0006055', 'cui_str': 'botulinum toxin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0949445', 'cui_str': 'Cervical Dystonia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}]",134.0,0.606297,"Mean TWSTRS total scores improved from 42.5 at baseline to 35.4 at Wk12 with aboBoNT-A and 42.4 to 40.4 with placebo (treatment difference: -4.8; 95% confidence interval [CI]: -8.5, -1.1; p = 0.011).","[{'ForeName': 'Atul T', 'Initials': 'AT', 'LastName': 'Patel', 'Affiliation': 'Kansas City Bone and Joint Clinic, Overland Park, KS, United States of America.'}, {'ForeName': 'Mark F', 'Initials': 'MF', 'LastName': 'Lew', 'Affiliation': 'Department of Neurology, Keck/University of Southern California School of Medicine, Los Angeles, CA, United States of America.'}, {'ForeName': 'Khashayar', 'Initials': 'K', 'LastName': 'Dashtipour', 'Affiliation': 'Department of Neurology/Movement Disorders, Loma Linda University, Loma Linda, CA, United States of America.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Isaacson', 'Affiliation': ""Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, FL, United States of America.""}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Hauser', 'Affiliation': ""University of South Florida Health Byrd Institute, Parkinson's Disease and Movement Disorders Center of Excellence, Tampa, FL, United States of America.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Ondo', 'Affiliation': 'Methodist Neurological Institute, Houston, TX, United States of America.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Maisonobe', 'Affiliation': 'Ipsen, Boulogne-Billancourt, France.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Wietek', 'Affiliation': 'Formerly of Ipsen, Cambridge, MA, United States of America.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Rubin', 'Affiliation': 'Formerly of Ipsen, Cambridge, MA, United States of America.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Brashear', 'Affiliation': 'University of California Davis School of Medicine, Sacramento, CA, United States of America.'}]",PloS one,['10.1371/journal.pone.0245827'] 2009,33526265,"Comments on ""Intravenous Mannitol reduces intra-compartmental pressure following tibia fractures: A randomized controlled trial""----relevant questions demanding attention related to the study.",,2021,,['tibia fractures'],['Intravenous mannitol'],['intra-compartmental pressure'],"[{'cui': 'C0040185', 'cui_str': 'Fracture of tibia'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",,0.0994177,,"[{'ForeName': 'Prateek', 'Initials': 'P', 'LastName': 'Behera', 'Affiliation': 'All India Institute of Medical Sciences, Bhopal, India. Electronic address: prateek.ortho@aiimsbhopal.edu.in.'}, {'ForeName': 'John Ashutosh', 'Initials': 'JA', 'LastName': 'Santoshi', 'Affiliation': 'All India Institute of Medical Sciences, Bhopal, India.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Dwivedi', 'Affiliation': 'All India Institute of Medical Sciences, Bhopal, India.'}, {'ForeName': 'Rajkumar', 'Initials': 'R', 'LastName': 'Selvanayagam', 'Affiliation': 'All India Institute of Medical Sciences, Bhopal, India.'}]",Chinese journal of traumatology = Zhonghua chuang shang za zhi,['10.1016/j.cjtee.2021.01.005'] 2010,33502448,"Effect of a Predictive Model on Planned Surgical Duration Accuracy, Patient Wait Time, and Use of Presurgical Resources: A Randomized Clinical Trial.","Importance Accurate surgical scheduling affects patients, clinical staff, and use of physical resources. Although numerous retrospective analyses have suggested a potential for improvement, the real-world outcome of implementing a machine learning model to predict surgical case duration appears not to have been studied. Objectives To assess accuracy and real-world outcome from implementation of a machine learning model that predicts surgical case duration. Design, Setting, and Participants This randomized clinical trial was conducted on 2 surgical campuses of a cancer specialty center. Patients undergoing colorectal and gynecology surgery at Memorial Sloan Kettering Cancer Center who were scheduled more than 1 day before surgery between April 7, 2018, and June 25, 2018, were included. The randomization process included 29 strata (11 gynecological surgeons at 2 campuses and 7 colorectal surgeons at a single campus) to ensure equal chance of selection for each surgeon and each campus. Patients undergoing more than 1 surgery during the study's timeframe were enrolled only once. Data analyses took place from July 2018 to November 2018. Interventions Cases were assigned to machine learning-assisted surgical predictions 1 day before surgery and compared with a control group. Main Outcomes and Measures The primary outcome measure was accurate prediction of the duration of each scheduled surgery, measured by (arithmetic) mean (SD) error and mean absolute error. Effects on patients and systems were measured by start time delay of following cases, the time between cases, and the time patients spent in presurgical area. Results A total of 683 patients were included (mean [SD] age, 55.8 [13.8] years; 566 women [82.9%]); 72 were excluded. Of the 683 patients included, those assigned to the machine learning algorithm had significantly lower mean (SD) absolute error (control group, 59.3 [72] minutes; intervention group, 49.5 [66] minutes; difference, -9.8 minutes; P = .03) compared with the control group. Mean start-time delay for following cases (patient wait time in a presurgical area), dropped significantly: 62.4 minutes (from 70.2 minutes to 7.8 minutes) and 16.7 minutes (from 36.9 minutes to 20.2 minutes) for patients receiving colorectal and gynecology surgery, respectively. The overall mean (SD) reduction of wait time was 33.1 minutes per patient (from 49.4 minutes to 16.3 minutes per patient). Improved accuracy did not adversely inflate time between cases (surgeon wait time). There was marginal improvement (1.5 minutes, from a mean of 70.6 to 69.1 minutes) in time between the end of cases and start of to-follow cases using the predictive model, compared with the control group. Patients spent a mean of 25.2 fewer minutes in the facility before surgery (173.3 minutes vs 148.1 minutes), indicating a potential benefit vis-à-vis available resources for other patients before and after surgery. Conclusions and Relevance Implementing machine learning-generated predictions for surgical case durations may improve case duration accuracy, presurgical resource use, and patient wait time, without increasing surgeon wait time between cases. Trial Registration ClinicalTrials.gov Identifier: NCT03471377.",2021,"There was marginal improvement (1.5 minutes, from a mean of 70.6 to 69.1 minutes) in time between the end of cases and start of to-follow cases using the predictive model, compared with the control group.","['683 patients', '2 surgical campuses of a cancer specialty center', ""Patients undergoing more than 1 surgery during the study's timeframe were enrolled only once"", 'Patients undergoing colorectal and gynecology surgery at Memorial Sloan Kettering Cancer Center who were scheduled more than 1 day before surgery between April 7, 2018, and June 25, 2018, were included', '29 strata (11 gynecological surgeons at 2 campuses and 7 colorectal surgeons at a single campus) to ensure equal chance of selection for each surgeon and each campus', 'A total of 683 patients were included (mean [SD] age, 55.8 [13.8] years; 566 women [82.9%]); 72 were excluded']","['machine learning model', 'machine learning-assisted surgical predictions 1 day before surgery and compared with a control group', 'machine learning algorithm']","['mean (SD) absolute error', 'overall mean (SD) reduction of wait time', 'time patients spent in presurgical area', 'Planned Surgical Duration Accuracy, Patient Wait Time, and Use of Presurgical Resources', 'Mean start-time delay', 'accurate prediction of the duration of each scheduled surgery, measured by (arithmetic) mean (SD) error and mean absolute error']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0586901', 'cui_str': 'Colorectal surgeon'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517561', 'cui_str': '13.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1301880', 'cui_str': 'Start time'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",683.0,0.0615311,"There was marginal improvement (1.5 minutes, from a mean of 70.6 to 69.1 minutes) in time between the end of cases and start of to-follow cases using the predictive model, compared with the control group.","[{'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Strömblad', 'Affiliation': 'Department of Strategy and Innovation, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Ryan G', 'Initials': 'RG', 'LastName': 'Baxter-King', 'Affiliation': 'Department of Strategy and Innovation, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Amirhossein', 'Initials': 'A', 'LastName': 'Meisami', 'Affiliation': 'Adobe Inc, San Jose, California.'}, {'ForeName': 'Shok-Jean', 'Initials': 'SJ', 'LastName': 'Yee', 'Affiliation': 'Department of Nursing, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Marcia R', 'Initials': 'MR', 'LastName': 'Levine', 'Affiliation': 'Department of Nursing, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Ostrovsky', 'Affiliation': 'Health Informatics, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Stein', 'Affiliation': 'Health Informatics, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Iasonos', 'Affiliation': 'Epidemiology-Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Weiser', 'Affiliation': 'Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Garcia-Aguilar', 'Affiliation': 'Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Nadeem R', 'Initials': 'NR', 'LastName': 'Abu-Rustum', 'Affiliation': 'Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Roger S', 'Initials': 'RS', 'LastName': 'Wilson', 'Affiliation': 'Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.'}]",JAMA surgery,['10.1001/jamasurg.2020.6361'] 2011,33502326,Effectiveness of Smartphone-Based Mindfulness Training on Maternal Perinatal Depression: Randomized Controlled Trial.,"BACKGROUND Despite potential for benefit, mindfulness remains an emergent area in perinatal mental health care, and evidence of smartphone-based mindfulness training for perinatal depression is especially limited. OBJECTIVE The objective of this study was to evaluate the effectiveness of a smartphone-based mindfulness training intervention during pregnancy on perinatal depression and other mental health problems with a randomized controlled design. METHODS Pregnant adult women who were potentially at risk of perinatal depression were recruited from an obstetrics clinic and randomized to a self-guided 8-week smartphone-based mindfulness training during pregnancy group or attention control group. Mental health indicators were surveyed over five time points through the postpartum period by online self-assessment. The assessor who collected the follow-up data was blind to the assignment. The primary outcome was depression as measured by symptoms, and secondary outcomes were anxiety, stress, affect, sleep, fatigue, memory, and fear. RESULTS A total of 168 participants were randomly allocated to the mindfulness training (n=84) or attention control (n=84) group. The overall dropout rate was 34.5%, and 52.4% of the participants completed the intervention. Mindfulness training participants reported significant improvement of depression (group × time interaction χ 2 4 =16.2, P=.003) and secondary outcomes (χ 2 4 =13.1, P=.01 for anxiety; χ 2 4 =8.4, P=.04 for positive affect) compared to attention control group participants. Medium between-group effect sizes were found on depression and positive affect at postintervention, and on anxiety in late pregnancy (Cohen d=0.47, -0.49, and 0.46, respectively). Mindfulness training participants reported a decreased risk of positive depressive symptom (Edinburgh Postnatal Depression Scale [EPDS] score>9) compared to attention control participants postintervention (odds ratio [OR] 0.391, 95% CI 0.164-0.930) and significantly higher depression symptom remission with different EPDS reduction scores from preintervention to postintervention (OR 3.471-27.986). Parity did not show a significant moderating effect; however, for nulliparous women, mindfulness training participants had significantly improved depression symptoms compared to nulliparous attention control group participants (group × time interaction χ 2 4 =18.1, P=.001). CONCLUSIONS Smartphone-based mindfulness training is an effective intervention in improving maternal perinatal depression for those who are potentially at risk of perinatal depression in early pregnancy. Nulliparous women are a promising subgroup who may benefit more from mindfulness training. TRIAL REGISTRATION Chinese Clinical Trial Registry ChiCTR1900028521; http://www.chictr.org.cn/showproj.aspx?proj=33474.",2021,"Medium between-group effect sizes were found on depression and positive affect at postintervention, and on anxiety in late pregnancy (Cohen d=0.47, -0.49, and 0.46, respectively).","['Maternal Perinatal Depression', 'Nulliparous women', 'Pregnant adult women who were potentially at risk of perinatal depression were recruited from an obstetrics clinic and randomized to a', '168 participants']","['mindfulness training (n=84) or attention control', 'Smartphone-Based Mindfulness Training', 'smartphone-based mindfulness training intervention', 'self-guided 8-week smartphone-based mindfulness training during pregnancy group or attention control group', 'Smartphone-based mindfulness training']","['risk of positive depressive symptom (Edinburgh Postnatal Depression Scale [EPDS] score>9', 'depression symptoms', 'overall dropout rate', 'depression as measured by symptoms, and secondary outcomes were anxiety, stress, affect, sleep, fatigue, memory, and fear', 'maternal perinatal depression', 'Mental health indicators', 'depression and positive affect at postintervention, and on anxiety in late pregnancy', 'depression symptom remission', 'depression']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0559477', 'cui_str': 'Perinatal asphyxia'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C4319556', 'cui_str': '168'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0559477', 'cui_str': 'Perinatal asphyxia'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",168.0,0.140469,"Medium between-group effect sizes were found on depression and positive affect at postintervention, and on anxiety in late pregnancy (Cohen d=0.47, -0.49, and 0.46, respectively).","[{'ForeName': 'Yaoyao', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'School of Nursing and Rehabilitation, Shandong University, Jinan, China.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'School of Nursing and Rehabilitation, Shandong University, Jinan, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'School of Nursing and Rehabilitation, Shandong University, Jinan, China.'}, {'ForeName': 'Qingyi', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'School of Nursing and Rehabilitation, Shandong University, Jinan, China.'}, {'ForeName': 'Alessandra N', 'Initials': 'AN', 'LastName': 'Bazzano', 'Affiliation': 'Tulane University School of Public Health and Tropical Medicine, New Orleans, LA, United States.'}, {'ForeName': 'Fenglin', 'Initials': 'F', 'LastName': 'Cao', 'Affiliation': 'School of Nursing and Rehabilitation, Shandong University, Jinan, China.'}]",Journal of medical Internet research,['10.2196/23410'] 2012,33499551,A Pilot Study to Examine Psychological and Neuropsychological Outcomes and a Novel Detoxification Program for Gulf War Illness.,"INTRODUCTION Exposures to environmental toxins have been associated with severe health problems for approximately one-quarter of the nearly 700,000 U.S. soldiers who served in the Gulf War between the years 1990 and 1991. Gulf War illness still affects about 30% of Gulf War veterans (GWV), causing reduced psychological wellness and neuropsychological function. METHOD AND MATERIALS This pilot study used a randomized wait-list control design to explore the feasibility and efficacy of a novel detoxification method for GWV exposed to toxicants such as pesticides, nerve gases, and pyridostigmine bromide. Our study included 32 GWV (67% male), with a mean age of 51 (range: 43-70, SD = 6.97), who participated in a 4- to 5-week treatment that was hypothesized to reduce the reported psychological and neuropsychological symptoms. Psychological measures used included tests given for the evaluation of neurocognitive function, including motor function for a dominant hand with the grooved pegboard test; verbal and visual immediate and delayed memory with the Wechsler Memory Scale III abbreviated subtests; executive function domains of attention, speed, and mental flexibility with trail making test parts A and B and Stroop color and word test. Psychological status was measured using the nine subscales of the Symptom Checklist-90-Revised. RESULTS Primary outcomes included between-group differences in self-reported psychological measures and a neuropsychological battery at 7-day and 3-month assessments. Baseline comparison revealed improvements in 16 of 19 psychological and neuropsychological measures at 7-day assessment and that 13 remained stable at 3-month assessment. CONCLUSIONS We conclude that the detoxification procedure provided improvement in psychological and cognitive function for GWV and that future study is warranted.",2021,"Baseline comparison revealed improvements in 16 of 19 psychological and neuropsychological measures at 7-day assessment and that 13 remained stable at 3-month assessment. ","['Gulf War Illness', 'severe health problems for approximately one-quarter of the nearly 700,000 U.S. soldiers who served in the Gulf War between the years 1990 and 1991', '32 GWV (67% male), with a mean age of 51 (range: 43-70, SD\u2009=\u20096.97']","['pyridostigmine bromide', 'Novel Detoxification Program']","['neurocognitive function, including motor function for a dominant hand with the grooved pegboard test; verbal and visual immediate and delayed memory with the Wechsler Memory Scale III abbreviated subtests; executive function domains of attention, speed, and mental flexibility with trail making test parts A and B and Stroop color and word test', 'psychological and neuropsychological symptoms', 'Psychological status', 'self-reported psychological measures and a neuropsychological battery', 'psychological and cognitive function']","[{'cui': 'C1449761', 'cui_str': 'Persian Gulf War, 1991'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0524647', 'cui_str': 'Soldiers'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0034262', 'cui_str': 'Pyridostigmine bromide'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0025516', 'cui_str': 'Detoxication, Drug, Metabolic'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0449722', 'cui_str': 'Dominant hand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0376364', 'cui_str': 'Delayed Memory'}, {'cui': 'C0451575', 'cui_str': 'Wechsler memory scale'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451331', 'cui_str': 'Neuropsychological battery'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.0219044,"Baseline comparison revealed improvements in 16 of 19 psychological and neuropsychological measures at 7-day assessment and that 13 remained stable at 3-month assessment. ","[{'ForeName': 'Donald F', 'Initials': 'DF', 'LastName': 'Graves', 'Affiliation': 'Psychology Department, Russell Sage College, Troy, NY 12181, USA.'}, {'ForeName': 'Gayle S', 'Initials': 'GS', 'LastName': 'Morse', 'Affiliation': 'Psychology Department, Russell Sage College, Troy, NY 12181, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Kerr', 'Affiliation': 'Department of Family & Community Medicine, University of Toronto, Toronto, ON M5G 1V7, Canada.'}, {'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Carpenter', 'Affiliation': 'Department of Environmental Health Sciences, University at Albany, Albany, NY 12144, USA.'}]",Military medicine,['10.1093/milmed/usaa486'] 2013,33497874,Mindfulness intervention for mild cognitive impairment led to attention-related improvements and neuroplastic changes: Results from a 9-month randomized control trial.,"Mindfulness-based interventions can enhance cognitive abilities among older adults, thereby effectively delaying cognitive decline. These cognitive enhancements are theorized to accompany neuroplastic changes in the brain. However, this mindfulness-associated neuroplasticity has yet to be documented adequately. A randomized controlled trial was carried out among participants with mild cognitive impairment (MCI) to examine the effects of a mindfulness-based intervention on various cognitive outcomes and cortical thickness (CT) in the context of age-related cognitive impairment. Participants were assigned to a mindfulness awareness program (MAP)(n = 27) and an active control condition - health education program (n = 27). In both, they attended weekly sessions for three months and subsequently, monthly sessions for six months. Cognitive assessments and structural scans were carried out across three time-points. Whole brain analyses on CT were carried out and were supplemented with region of interest-based analyses. ROI values and cognitive outcomes were analyzed with mixed MANOVAs and followed up with univariate ANOVAs. Nine-month MAP-associated gains in working memory span and divided attention, along with an increased CT in the right frontal pole and decreased CT in the left anterior cingulate were observed. Three-month MAP-associated CT increase was observed in the left inferior temporal gyrus but did not sustain thereafter. MAP led to significant cognitive gains and various CT changes. Most of these neurobehavioral changes, may require sustained effort across nine months, albeit at a reduced intensity. MAP can remediate certain cognitive impairments and engender neuroplastic effects even among those with MCI.",2021,"Nine-month MAP-associated gains in working memory span and divided attention, along with an increased CT in the right frontal pole and decreased CT in the left anterior cingulate were observed.","['participants with mild cognitive impairment (MCI', 'older adults']","['mindfulness awareness program (MAP)(n\xa0=\xa027) and an active control condition - health education program', 'Mindfulness-based interventions', 'Mindfulness intervention', 'mindfulness-based intervention']","['Cognitive assessments and structural scans', 'cognitive gains and various CT changes', 'ROI values and cognitive outcomes', 'cognitive abilities', 'CT increase', 'various cognitive outcomes and cortical thickness (CT']","[{'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",27.0,0.0197236,"Nine-month MAP-associated gains in working memory span and divided attention, along with an increased CT in the right frontal pole and decreased CT in the left anterior cingulate were observed.","[{'ForeName': 'Junhong', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Psychological Medicine, Mind Science Centre, Yong Loo Lin School of Medicine, National University of Singapore, Singapore. Electronic address: pcmyj@nus.edu.sg.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Rawtaer', 'Affiliation': 'Department of Psychiatry, Sengkang General Hospital, Singhealth Duke-Nus Academic Medical Centre, Singapore.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': 'Department of Psychological Medicine, Mind Science Centre, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Johnson', 'Initials': 'J', 'LastName': 'Fam', 'Affiliation': 'Department of Psychological Medicine, Mind Science Centre, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Alan Prem', 'Initials': 'AP', 'LastName': 'Kumar', 'Affiliation': 'Cancer Science Institute of Singapore, National University of Singapore, And Medical Science Cluster, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Irwin', 'Initials': 'I', 'LastName': 'Kee-Mun Cheah', 'Affiliation': 'Department of Biochemistry, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Honer', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Su', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Yuan Kun', 'Initials': 'YK', 'LastName': 'Lee', 'Affiliation': 'Department of Microbiology and Immunology, Yong Loo Lin School of Medicine, National University Hospital, Singapore.'}, {'ForeName': 'Ene Choo', 'Initials': 'EC', 'LastName': 'Tan', 'Affiliation': ""KK Research Laboratory, KK Women's and Children's Hospital, Singapore; SingHealth Duke-NUS Paediatrics Academic Clinical Program, Singapore.""}, {'ForeName': 'Ee Heok', 'Initials': 'EH', 'LastName': 'Kua', 'Affiliation': 'Department of Psychological Medicine, Mind Science Centre, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Rathi', 'Initials': 'R', 'LastName': 'Mahendran', 'Affiliation': 'Department of Psychological Medicine, Mind Science Centre, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Academic Development Department, Duke-NUS Medical School, 8 College Road, Singapore. Electronic address: pcmrathi@nus.edu.sg.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2021.01.032'] 2014,33506455,Endoscopic ultrasound (EUS)-guided fine needle biopsy alone vs. EUS-guided fine needle aspiration with rapid onsite evaluation in pancreatic lesions: a multicenter randomized trial.,"BACKGROUND Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is the standard in the diagnosis of solid pancreatic lesions, in particular when combined with rapid onsite evaluation of cytopathology (ROSE). More recently, a fork-tip needle for core biopsy (FNB) has been shown to be associated with excellent diagnostic yield. EUS-FNB alone has however not been compared with EUS-FNA + ROSE in a large clinical trial. Our aim was to compare EUS-FNB alone to EUS-FNA + ROSE in solid pancreatic lesions. METHODS A multicenter, non-inferiority, randomized controlled trial involving seven centers was performed. Solid pancreatic lesions referred for EUS were considered for inclusion. The primary end point was diagnostic accuracy. Secondary end points included sensitivity/specificity, mean number of needle passes, and cost. RESULTS 235 patients were randomized: 115 EUS-FNB alone and 120 EUS-FNA + ROSE. Overall, 217 patients had malignant histology. The diagnostic accuracy for malignancy of EUS-FNB alone was non-inferior to EUS-FNA + ROSE at 92.2 % (95 %CI 86.6 %-96.9 %) and 93.3 % (95 %CI 88.8 %-97.9 %), respectively ( P  = 0.72). Diagnostic sensitivity for malignancy was 92.5 % (95 %CI 85.7 %-96.7 %) for EUS-FNB alone vs. 96.5 % (93.0 %-98.6 %) for EUS-FNA + ROSE ( P  = 0.46), while specificity was 100 % in both. Adequate histological yield was obtained in 87.5 % of the EUS-FNB samples. The mean (SD) number of needle passes and procedure time favored EUS-FNB alone (2.3 [0.6] passes vs. 3.0 [1.1] passes [ P  < 0.001]; and 19.3 [8.0] vs. 22.7 [10.8] minutes [ P  = 0.008]). EUS-FNB alone cost on average 45 US dollars more than EUS-FNA + ROSE. CONCLUSION EUS-FNB alone is non-inferior to EUS-FNA + ROSE and is associated with fewer needle passes, shorter procedure time, and excellent histological yield at comparable cost.",2021,"The diagnostic accuracy for malignancy of EUS-FNB alone was non-inferior to EUS-FNA+ROSE 92.2% (95% CI: 86.6-96.9%) and 93.3% (95% CI: 88.8-97.9%), respectively p=0.72.","['217 patients had a malignant histology', 'pancreatic lesions', '235 patients', 'Multicenter non-inferiority RCT involving 7 centers']","['EUS-guided fine needle biopsy alone vs. EUS-guided fine needle aspiration', 'EUS-guided fine needle aspiration (EUS-FNA']","['diagnostic accuracy', 'Adequate histology yield', 'Mean number of needle of passes and procedure time favored EUS-FNB alone', 'Diagnostic sensitivity for malignancy', 'sensitivity/specificity, mean number of needle passes, and cost']","[{'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0085846', 'cui_str': 'Fine needle biopsy'}, {'cui': 'C1510483', 'cui_str': 'Fine needle aspiration biopsy - action'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",235.0,0.0979812,"The diagnostic accuracy for malignancy of EUS-FNB alone was non-inferior to EUS-FNA+ROSE 92.2% (95% CI: 86.6-96.9%) and 93.3% (95% CI: 88.8-97.9%), respectively p=0.72.","[{'ForeName': 'Yen-I', 'Initials': 'YI', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Avijit', 'Initials': 'A', 'LastName': 'Chatterjee', 'Affiliation': 'Division of Gastroenterology and Hepatology, Ottawa Hospital, Ottawa University, Ottawa, Ontario, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Berger', 'Affiliation': 'Division of Gastroenterology, Moncton Hospital, Moncton, New Brunswick, Canada.'}, {'ForeName': 'Yonca', 'Initials': 'Y', 'LastName': 'Kanber', 'Affiliation': 'Department of Pathology, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Wyse', 'Affiliation': 'Division of Gastroenterology and Hepatology, Jewish General Hospital, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lam', 'Affiliation': 'Division of Gastroenterology and Hepatology, St-Paul Hospital, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Gan', 'Affiliation': 'Division of Gastroenterology and Hepatology, Vancouver General Hospital, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Auger', 'Affiliation': 'Department of Pathology, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Sana', 'Initials': 'S', 'LastName': 'Kenshil', 'Affiliation': 'Division of Gastroenterology and Hepatology, Ottawa Hospital, Ottawa University, Ottawa, Ontario, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Telford', 'Affiliation': 'Division of Gastroenterology and Hepatology, St-Paul Hospital, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Fergal', 'Initials': 'F', 'LastName': 'Donnellan', 'Affiliation': 'Division of Gastroenterology and Hepatology, Vancouver General Hospital, Vancouver, British Columbia, Canada.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Quinlan', 'Affiliation': 'Division of Gastroenterology and Hepatology, Ottawa Hospital, Ottawa University, Ottawa, Ontario, Canada.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Lutzak', 'Affiliation': 'Division of Gastroenterology and Hepatology, Royal Alexandra Hospital, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Alshamsi', 'Affiliation': 'Division of Gastroenterology and Hepatology, Ottawa Hospital, Ottawa University, Ottawa, Ontario, Canada.'}, {'ForeName': 'Josee', 'Initials': 'J', 'LastName': 'Parent', 'Affiliation': 'Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Waschke', 'Affiliation': 'Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Alghamdi', 'Affiliation': 'Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Barkun', 'Affiliation': 'Department of Surgery, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Metrakos', 'Affiliation': 'Department of Surgery, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Prosanto', 'Initials': 'P', 'LastName': 'Chaudhury', 'Affiliation': 'Department of Surgery, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Martel', 'Affiliation': 'Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Dorreen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Ottawa Hospital, Ottawa University, Ottawa, Ontario, Canada.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Candido', 'Affiliation': 'Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Miller', 'Affiliation': 'Division of Gastroenterology and Hepatology, Jewish General Hospital, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'Adam', 'Affiliation': 'Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Barkun', 'Affiliation': 'Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Zogopoulos', 'Affiliation': 'Department of Surgery, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Clarence', 'Initials': 'C', 'LastName': 'Wong', 'Affiliation': 'Division of Gastroenterology and Hepatology, Royal Alexandra Hospital, University of Alberta, Edmonton, Alberta, Canada.'}]",Endoscopy,['10.1055/a-1375-9775'] 2015,33504496,Changes in Albuminuria Predict Cardiovascular and Renal Outcomes in Type 2 Diabetes: A Post Hoc Analysis of the LEADER Trial.,"OBJECTIVE A post hoc analysis to investigate the association between 1-year changes in albuminuria and subsequent risk of cardiovascular and renal events. RESEARCH DESIGN AND METHODS LEADER was a randomized trial of liraglutide up to 1.8 mg/day versus placebo added to standard care for 3.5-5 years in 9,340 participants with type 2 diabetes and high cardiovascular risk. We calculated change in urinary albumin-to-creatinine ratio (UACR) from baseline to 1 year in participants with >30% reduction ( n = 2,928), 30-0% reduction ( n = 1,218), or any increase in UACR ( n = 4,124), irrespective of treatment. Using Cox regression, risks of major adverse cardiovascular events (MACE) and a composite nephropathy outcome (from 1 year to end of trial in subgroups by baseline UACR [<30 mg/g, 30-300 mg/g, or ≥300 mg/g]) were assessed. The analysis was adjusted for treatment allocation alone as a fixed factor and for baseline variables associated with cardiovascular and renal outcomes. RESULTS For MACE, hazard ratios (HRs) for those with >30% and 30-0% UACR reduction were 0.82 (95% CI 0.71, 0.94; P = 0.006) and 0.99 (0.82, 1.19; P = 0.912), respectively, compared with any increase in UACR (reference). For the composite nephropathy outcome, respective HRs were 0.67 (0.49, 0.93; P = 0.02) and 0.97 (0.66, 1.43; P = 0.881). Results were independent of baseline UACR and consistent in both treatment groups. After adjustment, HRs were significant and consistent in >30% reduction subgroups with baseline micro- or macroalbuminuria. CONCLUSIONS A reduction in albuminuria during the 1st year was associated with fewer cardiovascular and renal outcomes, independent of treatment. Albuminuria monitoring remains an important part of diabetes care, with great unused potential.",2021,"For the composite nephropathy outcome, respective HRs were 0.67 (0.49, 0.93; P = 0.02) and 0.97 (0.66, 1.43; P = 0.881).","['9,340 participants with type 2 diabetes and high cardiovascular risk', 'Type 2 Diabetes']","['liraglutide', 'placebo']","['Albuminuria Predict Cardiovascular and Renal Outcomes', 'urinary albumin-to-creatinine ratio (UACR', 'Cox regression, risks of major adverse cardiovascular events (MACE) and a composite nephropathy outcome', 'cardiovascular and renal outcomes', 'hazard ratios (HRs', 'UACR (reference', 'albuminuria']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0033551', 'cui_str': 'Prostaglandin synthase'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}]",9340.0,0.15348,"For the composite nephropathy outcome, respective HRs were 0.67 (0.49, 0.93; P = 0.02) and 0.97 (0.66, 1.43; P = 0.881).","[{'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Persson', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark frederik.persson@regionh.dk.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Bain', 'Affiliation': 'Diabetes Research Unit Cymru, Swansea University Medical School, Swansea, U.K.'}, {'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Johannes F E', 'Initials': 'JFE', 'LastName': 'Mann', 'Affiliation': 'KfH Kidney Center, Munich, and Friedrich Alexander University, Erlangen, Germany.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pratley', 'Affiliation': 'AdventHealth Translational Research Institute, Orlando, FL.'}, {'ForeName': 'Itamar', 'Initials': 'I', 'LastName': 'Raz', 'Affiliation': 'Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Idorn', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Rasmussen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Bernt Johan', 'Initials': 'BJ', 'LastName': 'von Scholten', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc20-1622'] 2016,33506929,Effects of Lactobacillus rhamnosus GG on early postoperative outcome after pylorus-preserving pancreatoduodenectomy: a randomized trial.,"OBJECTIVE Pancreatoduodenectomy (PPPD) remains one of the most complex surgical procedures with high complication rates. Infectious complications, postoperative ileus and delayed gastric emptying in the perioperative period have a significant impact on the recovery from the treatment. Probiotics (PB) are known to have a beneficial effect as supportive therapy in major abdominal surgery but the evidence in pancreatic surgery is still limited. The aim of the study was to assess the influence of postoperative administration of PB on the early outcomes after PPPD. PATIENTS AND METHODS Forty patients undergoing pylorus-preserving PPPD were enrolled to prospective trial and randomized in two groups: A - control group (n=20) receiving standard nutrition and B - probiotic group (n=20) treated additionally with Lactobacillus rahmnosus GG (L. rhamnosus GG) in the postoperative period from the day of the surgery for 30 days. Gastrointestinal motility, infection complications, length of hospital stay, and mortality were compared in the perioperative period and during 2 follow-up (i.e., after 14 and 30 days). RESULTS There were no significant differences in mortality and infectious complications between groups. The length of hospital stay was shorter in the probiotic group compared to control (10 days vs. 8, respectively). The positive effect of L. rhamnosus GG on gastrointestinal tract's motility was observed, including earlier recurrence of postoperative bowel movements (group B: after 3.75 days vs. group A: 2.15 days), passing gasses (group B after 4 days vs. group A 2.9 days) and the first postoperative stool (group B after 5.84 days vs. group A 3.85 days). L. rhamnosus GG improved the appetite in postoperative day 1, 3, 5, 7 and 30 days after the surgery. CONCLUSIONS L. rhamnosus GG improves the function of the gastrointestinal tract after major pancreatic surgery and may reduce the length of hospital stay.",2021,"The length of hospital stay was shorter in the probiotic group compared to control (10 days vs. 8, respectively).","['Forty patients undergoing pylorus-preserving PPPD', 'after pylorus-preserving pancreatoduodenectomy']","['Lactobacillus rhamnosus GG', 'Probiotics (PB', 'L. rhamnosus GG', ' control group (n=20) receiving standard nutrition and B - probiotic group (n=20) treated additionally with Lactobacillus rahmnosus GG (L. rhamnosus GG', 'PB']","['early postoperative outcome', 'earlier recurrence of postoperative bowel movements', 'length of hospital stay', 'mortality and infectious complications', 'Infectious complications, postoperative ileus and delayed gastric emptying', ""gastrointestinal tract's motility"", 'Gastrointestinal motility, infection complications, length of hospital stay, and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0162838', 'cui_str': 'Porokeratosis plantaris palmaris et disseminata'}, {'cui': 'C4324570', 'cui_str': 'Pylorus preserving pancreatoduodenectomy'}]","[{'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0400877', 'cui_str': 'Postoperative ileus'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0017184', 'cui_str': 'Gastrointestinal Motility'}]",40.0,0.0603075,"The length of hospital stay was shorter in the probiotic group compared to control (10 days vs. 8, respectively).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Folwarski', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Medical University of Gdansk, Poland; Home Enteral and Parenteral Nutrition Unit, General Surgery, Nicolaus Copernicus Hospital, Gdansk, Poland. marcinfol@gumed.edu.pl.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dobosz', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Małgorzewicz', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Skonieczna-Żydecka', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kaźmierczak-Siedlecka', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_202101_24407'] 2017,33512328,Deliberative and Paternalistic Interaction Styles for Conversational Agents in Digital Health: Procedure and Validation Through a Web-Based Experiment.,"BACKGROUND Recent years have witnessed a constant increase in the number of people with chronic conditions requiring ongoing medical support in their everyday lives. However, global health systems are not adequately equipped for this extraordinarily time-consuming and cost-intensive development. Here, conversational agents (CAs) can offer easily scalable and ubiquitous support. Moreover, different aspects of CAs have not yet been sufficiently investigated to fully exploit their potential. One such trait is the interaction style between patients and CAs. In human-to-human settings, the interaction style is an imperative part of the interaction between patients and physicians. Patient-physician interaction is recognized as a critical success factor for patient satisfaction, treatment adherence, and subsequent treatment outcomes. However, so far, it remains effectively unknown how different interaction styles can be implemented into CA interactions and whether these styles are recognizable by users. OBJECTIVE The objective of this study was to develop an approach to reproducibly induce 2 specific interaction styles into CA-patient dialogs and subsequently test and validate them in a chronic health care context. METHODS On the basis of the Roter Interaction Analysis System and iterative evaluations by scientific experts and medical health care professionals, we identified 10 communication components that characterize the 2 developed interaction styles: deliberative and paternalistic interaction styles. These communication components were used to develop 2 CA variations, each representing one of the 2 interaction styles. We assessed them in a web-based between-subject experiment. The participants were asked to put themselves in the position of a patient with chronic obstructive pulmonary disease. These participants were randomly assigned to interact with one of the 2 CAs and subsequently asked to identify the respective interaction style. Chi-square test was used to assess the correct identification of the CA-patient interaction style. RESULTS A total of 88 individuals (42/88, 48% female; mean age 31.5 years, SD 10.1 years) fulfilled the inclusion criteria and participated in the web-based experiment. The participants in both the paternalistic and deliberative conditions correctly identified the underlying interaction styles of the CAs in more than 80% of the assessments (X 2 1,88 =38.2; P<.001; phi coefficient r φ =0.68). The validation of the procedure was hence successful. CONCLUSIONS We developed an approach that is tailored for a medical context to induce a paternalistic and deliberative interaction style into a written interaction between a patient and a CA. We successfully tested and validated the procedure in a web-based experiment involving 88 participants. Future research should implement and test this approach among actual patients with chronic diseases and compare the results in different medical conditions. This approach can further be used as a starting point to develop dynamic CAs that adapt their interaction styles to their users.",2021,"The participants in both the paternalistic and deliberative conditions correctly identified the underlying interaction styles of the CAs in more than 80% of the assessments (X 2 1,88 =38.2; P<.001; phi coefficient r φ =0.68).","['actual patients with chronic diseases', '88 individuals (42/88, 48% female; mean age 31.5 years, SD 10.1 years) fulfilled the inclusion criteria and participated in the web-based experiment', 'patient with chronic obstructive pulmonary disease', '88 participants']",['conversational agents (CAs'],['underlying interaction styles of the CAs'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]",88.0,0.0294647,"The participants in both the paternalistic and deliberative conditions correctly identified the underlying interaction styles of the CAs in more than 80% of the assessments (X 2 1,88 =38.2; P<.001; phi coefficient r φ =0.68).","[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Schachner', 'Affiliation': 'Department of Management, Technology, and Economics, Centre for Digital Health Interventions, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Gross', 'Affiliation': 'Department of Management, Technology, and Economics, Centre for Digital Health Interventions, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Hasl', 'Affiliation': 'Department of Educational Sciences, University of Potsdam, Potsdam, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'V Wangenheim', 'Affiliation': 'Department of Management, Technology, and Economics, Centre for Digital Health Interventions, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Kowatsch', 'Affiliation': 'Department of Management, Technology, and Economics, Centre for Digital Health Interventions, ETH Zurich, Zurich, Switzerland.'}]",Journal of medical Internet research,['10.2196/22919'] 2018,33516141,Oral hydration compared to intravenous hydration in the prevention of post-contrast acute kidney injury in patients with chronic kidney disease stage IIIb: A phase III non-inferiority study (NICIR study).,"OBJECTIVE To evaluate the non-inferiority of oral hydration compared to intravenous (i.v.) hydration in the prevention of post-contrast acute kidney injury (PC-AKI) in patients with stage IIIb chronic kidney disease (CKD) referred for an elective contrast-enhanced computed tomography (CE-CT). MATERIAL AND METHODS This is a prospective, randomized, phase 3, parallel-group, open-label, non-inferiority trial. Patients were randomly assigned 1:1 to receive prophylaxis against PC-AKI either with oral hydration: 500 mL of water two hours before and 2000 mL during the 24 h after performing CE-CT or i.v. hydration: sodium bicarbonate (166 mmol/L) 3 mL/kg/h starting one hour before and sodium bicarbonate (166 mmol/L) 1 mL/kg/h during the first hour after CE-CT. 100 mL of non-ionic iodinated contrast was administered in all cases. The primary outcome was the proportion of PC-AKI in the first 48-72 h after CE-CT. Secondary outcomes were persistent PC-AKI, the need for hemodialysis, and the occurrence of adverse events related to prophylaxis. RESULTS Of 264 patients randomized between January 2018 and January 2019, 114 received oral hydration, and 114 received i.v. hydration and were evaluable. No significant differences were found (p > 0.05) between arms in clinical characteristics or risk factors. PC-AKI rate was 4.4 % (95 %CI: 1.4-9.9 %) in the oral hydration arm and 5.3 % (95 %CI: 2.0-11.1%) in the i.v. hydration arm. The persistent PC-AKI rate was 1.8 % (95 %CI: 0.2-6.2 %) in both arms. No patient required dialysis during the first month after CE-CT or had adverse effects related to the hydration regime. CONCLUSION In those with stage IIIb CKD referred for an elective CE-CT, we provide evidence of non-inferiority of oral hydration compared to i.v. hydration in the prevention of PC-AKI.",2021,PC-AKI rate was 4.4 % (95 %CI: 1.4-9.9 %) in the oral hydration arm and 5.3 % (95 %CI: 2.0-11.1%) in the i.v.,"['264 patients randomized between January 2018 and January 2019', 'patients with stage IIIb chronic kidney disease (CKD', 'patients with chronic kidney disease stage IIIb']","['Oral hydration', 'oral hydration compared to intravenous (i.v.) hydration', 'intravenous hydration', 'elective contrast-enhanced computed tomography (CE-CT', 'oral hydration', 'sodium bicarbonate', 'hydration: sodium bicarbonate (166\u202fmmol/L) 3\u202fmL/kg/h', 'prophylaxis against PC-AKI either with oral hydration']","['persistent PC-AKI rate', 'proportion of PC-AKI', 'PC-AKI rate', 'persistent PC-AKI, the need for hemodialysis, and the occurrence of adverse events related to prophylaxis', 'adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C1532580', 'cui_str': 'mL/kg/hr'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}]","[{'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",264.0,0.0990071,PC-AKI rate was 4.4 % (95 %CI: 1.4-9.9 %) in the oral hydration arm and 5.3 % (95 %CI: 2.0-11.1%) in the i.v.,"[{'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Sebastià', 'Affiliation': 'Department of Radiology, Hospital Clínic de Barcelona, Barcelona, Spain. Electronic address: msebasti@clinic.cat.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Páez-Carpio', 'Affiliation': 'Department of Radiology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Guillen', 'Affiliation': 'Department of Nephrology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Paño', 'Affiliation': 'Department of Radiology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Garcia-Cinca', 'Affiliation': 'Clinical Trials Unit, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Poch', 'Affiliation': 'Department of Nephrology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Oleaga', 'Affiliation': 'Department of Radiology, Hospital Clínic de Barcelona, Barcelona, Spain; Universitat de Barcelona, Campus Clínic, Barcelona, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Nicolau', 'Affiliation': 'Department of Radiology, Hospital Clínic de Barcelona, Barcelona, Spain; Universitat de Barcelona, Campus Clínic, Barcelona, Spain.'}]",European journal of radiology,['10.1016/j.ejrad.2020.109509'] 2019,33523189,"Effectiveness of a Female Community Health Volunteer-Delivered Intervention in Reducing Blood Glucose Among Adults With Type 2 Diabetes: An Open-Label, Cluster Randomized Clinical Trial.","Importance Female community health volunteers (FCHVs) are frontline community health workers who have been a valuable resource in improving public health outcomes in Nepal, but their value is understudied in diabetes care. Objective To assess whether an FCHV-delivered intervention is associated with reduced blood glucose levels among adults with type 2 diabetes. Design, Setting, and Participants This community-based, open-label, 2-group, cluster randomized clinical trial with a 12-month delayed control group design was conducted in 14 clusters of a semiurban setting in Western Nepal. A total of 244 adults with type 2 diabetes were recruited between November 2016 and April 2017. The follow-up assessment was conducted at 12 months after enrollment. Data analysis was performed from January to February 2019. Interventions Seven clusters were randomized to the FCHV-delivered intervention in which 20 FCHVs provided home visits 3 times a year (once every 4 months) for health promotion counseling and blood glucose monitoring. If participants had blood glucose levels of 126 mg/dL or higher, the FCHVs referred them to the nearest health facility, and if participants were taking antihyperglycemic medication, they were followed up by the FCHVs for adherence to their medication. Seven clusters were randomized to usual care (control group). Main Outcomes and Measures The primary outcome was the change in mean fasting blood glucose from baseline to 12-month follow-up. Secondary outcomes included changes in mean systolic blood pressure, mean diastolic blood pressure, mean body mass index, percentage change in the proportion of low physical activity, harmful alcohol consumption, current smoking, low fruit and vegetable intake, and antihyperglycemic medication status. Results Of 244 participants, 120 women (56.6%) and 92 men (43.4%) completed the trial. At baseline, the mean (SD) age was 51.71 (8.77) years; 127 participants were in the intervention group, and 117 participants were in the control group (usual care). At baseline, the mean (SD) fasting blood glucose level was 156.06 (44.48) mg/dL (158.48 [45.50] mg/dL in the intervention group and 153.43 [43.39] mg/dL in the control group). At 12-month follow-up, the mean fasting blood glucose decreased by 22.86 mg/dL in the intervention group, whereas it increased by 7.38 mg/dL in the control group. The mean reduction was 27.90 mg/dL greater with the intervention (95% CI, -37.62 to -18.18 mg/dL; P < .001). In secondary outcome analyses, there was a greater decline in mean systolic blood pressure in the intervention group than in the control group (-5.40 mm Hg; 95% CI, -8.88 to -1.92 mm Hg; P = .002). There was detectable difference in the intake of antihyperglycemic medication between the groups (relative risk, 1.35; 95% CI, 1.1 to 1.74; P = .02). Conclusions and Relevance These findings suggest that an FCHV-delivered intervention is associated with reduced blood glucose levels among adults with type 2 diabetes in a low-resource setting in Nepal. Trial Registration ClinicalTrials.gov Identifier: NCT03304158.",2021,"The mean reduction was 27.90 mg/dL greater with the intervention (95% CI, -37.62 to -18.18 mg/dL; P < .001).","['Interventions\n\n\nSeven clusters', 'adults with type 2 diabetes', '244 adults with type 2 diabetes were recruited between November 2016 and April 2017', 'Adults With Type 2 Diabetes', 'Importance\n\n\nFemale community health volunteers (FCHVs', 'mean (SD) age was 51.71 (8.77) years; 127 participants were in the intervention group, and 117 participants were in the control group (usual care', '244 participants, 120 women (56.6%) and 92 men (43.4%) completed the trial', 'adults with type 2 diabetes in a low-resource setting in Nepal']","['FCHV-delivered intervention in which 20 FCHVs provided home visits 3 times a year (once every 4 months) for health promotion counseling and blood glucose monitoring', 'usual care (control group', 'Female Community Health Volunteer-Delivered Intervention', 'FCHV-delivered intervention']","['mean systolic blood pressure', 'change in mean fasting blood glucose', 'intake of antihyperglycemic medication', 'mean fasting blood glucose', 'mean (SD) fasting blood glucose level', 'mean reduction', 'blood glucose levels', 'changes in mean systolic blood pressure, mean diastolic blood pressure, mean body mass index, percentage change in the proportion of low physical activity, harmful alcohol consumption, current smoking, low fruit and vegetable intake, and antihyperglycemic medication status', 'Blood Glucose']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0585338', 'cui_str': 'Every four months'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}]",244.0,0.0609052,"The mean reduction was 27.90 mg/dL greater with the intervention (95% CI, -37.62 to -18.18 mg/dL; P < .001).","[{'ForeName': 'Bishal', 'Initials': 'B', 'LastName': 'Gyawali', 'Affiliation': 'Section of Global Health, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Rajan', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'Macquarie University Centre for the Health Economy, Macquarie Park, Sydney, Australia.'}, {'ForeName': 'Shiva Raj', 'Initials': 'SR', 'LastName': 'Mishra', 'Affiliation': 'Nepal Development Society, Chitwan, Nepal.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Neupane', 'Affiliation': 'Nepal Development Society, Chitwan, Nepal.'}, {'ForeName': 'Abhinav', 'Initials': 'A', 'LastName': 'Vaidya', 'Affiliation': 'Department of Community Medicine, Kathmandu Medical College and Teaching Hospital, Kathmandu, Nepal.'}, {'ForeName': 'Annelli', 'Initials': 'A', 'LastName': 'Sandbæk', 'Affiliation': 'Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Kallestrup', 'Affiliation': 'Department of Public Health, Aarhus University, Aarhus, Denmark.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.35799'] 2020,33821793,Identification of human glucocorticoid response markers using integrated multi-omic analysis from a randomized crossover trial.,"Background Glucocorticoids are among the most commonly prescribed drugs, but there is no biomarker that can quantify their action. The aim of the study was to identify and validate circulating biomarkers of glucocorticoid action. Methods In a randomized, crossover, single-blind, discovery study, 10 subjects with primary adrenal insufficiency (and no other endocrinopathies) were admitted at the in-patient clinic and studied during physiological glucocorticoid exposure and withdrawal. A randomization plan before the first intervention was used. Besides mild physical and/or mental fatigue and salt craving, no serious adverse events were observed. The transcriptome in peripheral blood mononuclear cells and adipose tissue, plasma miRNAomic, and serum metabolomics were compared between the interventions using integrated multi-omic analysis. Results We identified a transcriptomic profile derived from two tissues and a multi-omic cluster, both predictive of glucocorticoid exposure. A microRNA (miR-122-5p) that was correlated with genes and metabolites regulated by glucocorticoid exposure was identified (p=0.009) and replicated in independent studies with varying glucocorticoid exposure (0.01 ≤ p≤0.05). Conclusions We have generated results that construct the basis for successful discovery of biomarker(s) to measure effects of glucocorticoids, allowing strategies to individualize and optimize glucocorticoid therapy, and shedding light on disease etiology related to unphysiological glucocorticoid exposure, such as in cardiovascular disease and obesity. Funding The Swedish Research Council (Grant 2015-02561 and 2019-01112); The Swedish federal government under the LUA/ALF agreement (Grant ALFGBG-719531); The Swedish Endocrinology Association; The Gothenburg Medical Society; Wellcome Trust; The Medical Research Council, UK; The Chief Scientist Office, UK; The Eva Madura's Foundation; The Research Foundation of Copenhagen University Hospital; and The Danish Rheumatism Association. Clinical trial number NCT02152553.",2021,"A microRNA (miR-122-5p) that was correlated with genes and metabolites regulated by glucocorticoid exposure was identified (p=0.009) and replicated in independent studies with varying glucocorticoid exposure (0.01 ≤ p≤0.05). ",['10 subjects with primary adrenal insufficiency (and no other endocrinopathies) were admitted at the in-patient clinic and studied during physiological glucocorticoid exposure and withdrawal'],[],"['mild physical and/or mental fatigue and salt craving', 'peripheral blood mononuclear cells and adipose tissue, plasma miRNAomic, and serum metabolomics']","[{'cui': 'C0001403', 'cui_str': ""Addison's disease""}, {'cui': 'C0014130', 'cui_str': 'Disorder of endocrine system'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}]",[],"[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0240928', 'cui_str': 'Salt craving'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}]",10.0,0.0631733,"A microRNA (miR-122-5p) that was correlated with genes and metabolites regulated by glucocorticoid exposure was identified (p=0.009) and replicated in independent studies with varying glucocorticoid exposure (0.01 ≤ p≤0.05). ","[{'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Chantzichristos', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Institute of Medicine at Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Per-Arne', 'Initials': 'PA', 'LastName': 'Svensson', 'Affiliation': 'Department of Molecular and Clinical Medicine, Institute of Medicine at Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Terence', 'Initials': 'T', 'LastName': 'Garner', 'Affiliation': 'Division of Developmental Biology & Medicine, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Camilla Am', 'Initials': 'CA', 'LastName': 'Glad', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Institute of Medicine at Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Brian R', 'Initials': 'BR', 'LastName': 'Walker', 'Affiliation': 'Clinical and Translational Research Institute, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Ragnhildur', 'Initials': 'R', 'LastName': 'Bergthorsdottir', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Institute of Medicine at Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Oskar', 'Initials': 'O', 'LastName': 'Ragnarsson', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Institute of Medicine at Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Penelope', 'Initials': 'P', 'LastName': 'Trimpou', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Institute of Medicine at Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Roland H', 'Initials': 'RH', 'LastName': 'Stimson', 'Affiliation': 'BHF/University Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Stina W', 'Initials': 'SW', 'LastName': 'Borresen', 'Affiliation': 'Department of Medical Endocrinology and Metabolism, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Feldt-Rasmussen', 'Affiliation': 'Department of Medical Endocrinology and Metabolism, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Per-Anders', 'Initials': 'PA', 'LastName': 'Jansson', 'Affiliation': 'Wallenberg Laboratory, Department of Molecular and Clinical Medicine, Institute of Medicine at Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Stanko', 'Initials': 'S', 'LastName': 'Skrtic', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Institute of Medicine at Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Stevens', 'Affiliation': 'Division of Developmental Biology & Medicine, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Gudmundur', 'Initials': 'G', 'LastName': 'Johannsson', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Institute of Medicine at Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",eLife,['10.7554/eLife.62236'] 2021,33527729,The influence of new immediate tissue level abutment on crestal bone stability of subcrestally placed implants: A 1-year randomized controlled clinical trial.,"BACKGROUND The relation between implant abutment disconnection (AD) and increased crestal bone loss is still debated. PURPOSE To compare bone changes below implant-abutment junction of subcrestally placed implants between: (1) implant level restorations, that underwent four ADs and (2) implants with immediate tissue level abutment with no AD, 1 month (T2) and 1-year (T3) after final restoration delivery. MATERIALS AND METHODS Sixty-four patients received 64 bone level implants with platform-switching and conical connection in edentulous sites of posterior mandible and maxilla. All implants were placed 1.5 mm subcrestally and distributed among: (1) control group, that received a regular healing abutment and (2) test group with immediate tissue level (ITL) abutment, which was torqued to implants during surgery, transforming bone level implant to tissue level type. After 2-3 months of healing and a 1-month temporization, final zirconia-based screw-retained crowns were delivered to both groups. Crestal bone levels were calculated after final crown delivery (T2); after 1-year follow-up (T3) and compared using Mann-Whitney U test (p ≤ .05). RESULTS Early bone loss of the test and control groups was 0.14 ± 0.27 mm and 0.64 ± 0.64 mm, respectively; the 0.5 mm difference was statistically significant (p = .0001). Late bone loss was 0.06 ± 0.16 mm and 0.21 ± 0.56 mm for the test and control group, respectively; the 0.15 mm difference between the groups was no more statistically significant (p = .22). Both groups displayed bone gain, 0.08 and 0.43 mm, respectively, and the overall crestal bone loss was reduced. CONCLUSIONS Immediate tissue level abutments can significantly reduce early bone loss when measured 1 month after final prosthesis delivery, however, after 1-year follow-up, difference between the groups was no more statistically significant.",2021,"Both groups displayed bone gain, 0.08 and 0.43 mm, respectively, and the overall crestal bone loss was reduced. ","['subcrestally placed implants', 'Sixty-four patients received 64 bone level implants with platform-switching and conical connection in edentulous sites of posterior mandible and maxilla']","['new immediate tissue level abutment', 'regular healing abutment and (2) test group with immediate tissue level (ITL) abutment, which was torqued to implants during surgery, transforming bone level implant to tissue level type', 'implant abutment disconnection (AD']","['Late bone loss', 'overall crestal bone loss', 'Crestal bone levels', 'crestal bone loss', 'bone gain', 'crestal bone stability', 'early bone loss']","[{'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C3266125', 'cui_str': 'Healing abutment'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",64.0,0.0834988,"Both groups displayed bone gain, 0.08 and 0.43 mm, respectively, and the overall crestal bone loss was reduced. ","[{'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Linkevicius', 'Affiliation': 'Institute of Odontology, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Rokas', 'Initials': 'R', 'LastName': 'Linkevicius', 'Affiliation': 'Vilnius Research Group, Vilnius, Lithuania.'}, {'ForeName': 'Evelina', 'Initials': 'E', 'LastName': 'Gineviciute', 'Affiliation': 'Vilnius Research Group, Vilnius, Lithuania.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Alkimavicius', 'Affiliation': 'Vilnius Research Group, Vilnius, Lithuania.'}, {'ForeName': 'Asta', 'Initials': 'A', 'LastName': 'Mazeikiene', 'Affiliation': 'Institute of Biomedical Sciences, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Linkeviciene', 'Affiliation': 'Institute of Odontology, Vilnius University, Vilnius, Lithuania.'}]",Clinical implant dentistry and related research,['10.1111/cid.12979'] 2022,33821693,A randomized study of natalizumab dosing regimens for relapsing-remitting multiple sclerosis.,"BACKGROUND REFINE was an exploratory, dose- and frequency-blinded, prospective, randomized, dose-ranging study in relapsing-remitting multiple sclerosis (RRMS) patients. OBJECTIVE To examine the efficacy, safety, and tolerability of natalizumab administered via various regimens in RRMS patients. METHODS Clinically stable RRMS patients previously treated with 300 mg natalizumab intravenously for ⩾12 months were randomized to one of six natalizumab regimens over 60 weeks: 300 mg administered intravenously or subcutaneously every 4 weeks (Q4W), 300 mg intravenously or subcutaneously every 12 weeks (Q12W), or 150 mg intravenously or subcutaneously Q12W. The primary endpoint was the mean cumulative number of combined unique active magnetic resonance imaging (MRI) lesions at week 60. RESULTS In total, 290 patients were enrolled. All Q12W dosing arms were associated with increased clinical and MRI disease activity and closed early; ⩾39.5% of patients in each Q12W arm met rescue criteria. In the 300 mg intravenous and subcutaneous Q4 W arms, the mean cumulative number of combined unique active MRI lesions was 0.23 and 0.02, respectively; annualized relapse rates were 0.07 and 0.08, respectively; and trough natalizumab serum levels and α4-integrin saturation were comparable. CONCLUSION Natalizumab 300 mg subcutaneous Q4W was comparable to 300 mg intravenous Q4W dosing with respect to efficacy, pharmacokinetics/pharmacodynamics, and safety.",2021,All Q12W dosing arms were associated with increased clinical and MRI disease activity and closed early; ⩾39.5% of patients in each Q12W arm met rescue criteria.,"['relapsing-remitting multiple sclerosis (RRMS) patients', 'RRMS patients', 'Clinically stable RRMS patients previously treated with 300 mg natalizumab intravenously for ⩾12 months', 'relapsing-remitting multiple sclerosis', '290 patients were enrolled']","['Natalizumab 300 mg subcutaneous Q4W', 'subcutaneously Q12W', 'natalizumab']","['mean cumulative number of combined unique active magnetic resonance imaging (MRI) lesions', 'efficacy, safety, and tolerability', 'trough natalizumab serum levels and α4-integrin saturation', 'annualized relapse rates', 'efficacy, pharmacokinetics/pharmacodynamics, and safety', 'mean cumulative number of combined unique active MRI lesions', 'clinical and MRI disease activity']","[{'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1522002', 'cui_str': 'RRM Motif'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1172734', 'cui_str': 'natalizumab'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C5191218', 'cui_str': '290'}]","[{'cui': 'C1172734', 'cui_str': 'natalizumab'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C1172734', 'cui_str': 'natalizumab'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021701', 'cui_str': 'Integrins'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",290.0,0.131458,All Q12W dosing arms were associated with increased clinical and MRI disease activity and closed early; ⩾39.5% of patients in each Q12W arm met rescue criteria.,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Trojano', 'Affiliation': 'Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari ""Aldo Moro,"" Bari, Italy.'}, {'ForeName': 'Lluís', 'Initials': 'L', 'LastName': 'Ramió-Torrentà', 'Affiliation': 'Neurology Department, Dr. Josep Trueta University Hospital, Girona Biomedical Research Institute (IDIBGI), Medical Sciences Department, University of Girona, Girona, Spain.'}, {'ForeName': 'Luigi Me', 'Initials': 'LM', 'LastName': 'Grimaldi', 'Affiliation': 'Unità Operativa Neurologia, Fondazione Istituto San Raffaele G. Giglio di Cefalù, Cefalù, Italy.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Lubetzki', 'Affiliation': 'Sorbonne University and Paris Brain Institute (ICM), Pitié-Salpêtrière Hospital, Department of Neurology, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Schippling', 'Affiliation': 'Neuroimmunology and Multiple Sclerosis Research Section, Department of Neurology, University Hospital Zurich and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Karleyton C', 'Initials': 'KC', 'LastName': 'Evans', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Ren', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Kumar Kandadi', 'Initials': 'KK', 'LastName': 'Muralidharan', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Licata', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Arie R', 'Initials': 'AR', 'LastName': 'Gafson', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/13524585211003020'] 2023,33821679,Tu'Washindi na PrEP: Working With Young Women and Service Providers to Design an Intervention for PrEP Uptake and Adherence in the Context of Gender-Based Violence.,"HIV pre-exposure prophylaxis (PrEP) reduces HIV acquisition among adolescent girls and young women (AGYW). Existing evidence suggests that uptake and adherence are low among AGYW and that relationship factors such as gender-based violence (GBV) are important barriers. Through a community-based participatory research (CBPR) process, a youth advisory board (YAB), service providers (SP), and a study team developed the Tu'Washindi na PrEP intervention to support AGYW PrEP use in the context of GBV. The YAB also guided the formative research and interpretation of results. The authors pretested the intervention with SP, AGYW and their partners, and community change agents, and then developed guides for AGYW support clubs, community-based male sensitization sessions, and couples-based events that included formulation of story lines for dramatized PrEP negotiation and information dissemination skills. Stakeholder engagement led to an intervention responsive to AGYW's needs for PrEP support in the context of their relationships, which was evaluated through a 6-month pilot community randomized controlled trial.",2021,"Stakeholder engagement led to an intervention responsive to AGYW's needs for PrEP support in the context of their relationships, which was evaluated through a 6-month pilot community randomized controlled trial.",['adolescent girls and young women (AGYW'],"[""Tu'Washindi na PrEP"", 'HIV pre-exposure prophylaxis (PrEP']",['HIV acquisition'],"[{'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C1096319', 'cui_str': 'Prophylaxis against HIV infection'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",,0.0307508,"Stakeholder engagement led to an intervention responsive to AGYW's needs for PrEP support in the context of their relationships, which was evaluated through a 6-month pilot community randomized controlled trial.","[{'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Hartmann', 'Affiliation': ""Women's Global Health Imperative, RTI International, Berkeley, California.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Otticha', 'Affiliation': 'Impact Research Development Organization, Kisumu, Kenya.'}, {'ForeName': 'Kawango', 'Initials': 'K', 'LastName': 'Agot', 'Affiliation': 'Impact Research Development Organization, Kisumu, Kenya.'}, {'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Minnis', 'Affiliation': ""Women's Global Health Imperative, RTI International, Berkeley, California.""}, {'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Montgomery', 'Affiliation': ""Women's Global Health Imperative, RTI International, Berkeley, California.""}, {'ForeName': 'Sarah T', 'Initials': 'ST', 'LastName': 'Roberts', 'Affiliation': ""Women's Global Health Imperative, RTI International, Berkeley, California.""}]",AIDS education and prevention : official publication of the International Society for AIDS Education,['10.1521/aeap.2021.33.2.103'] 2024,33540413,Health Preference Measures in Patients with Obstructive Sleep Apnea Syndrome Undergoing Continuous Positive Airway Pressure Therapy: Data from a Randomized Trial.,"BACKGROUND In patients with obstructive sleep apnea syndrome (OSAS), the preference-based, health-related quality of life in terms of utility has not been extensively studied. OBJECTIVE To address this point, we compared the performance of different instruments assessing utility in patients with OSAS undergoing continuous positive airway pressure (CPAP) therapy. MATERIALS AND METHODS Data of 208 patients with OSAS (28 women, mean ± SE age 54.4 ± 0.7 years, apnea-hypopnea index (AHI) 51.9 ± 1.8/h, Epworth sleepiness score 13.4 ± 0.2) participating in a randomized trial of different CPAP modalities over 2 years were analyzed. Evaluations included sleep studies, Epworth sleepiness scale, and several utility instruments that measure subjective health preference on a scale ranging from 1 (most preferred and perfect health) to 0 (least preferred and very poor health). RESULTS After 2 years of CPAP therapy, the mean ± SE AHI was 6.7 ± 1.5/h and Epworth score 7.9 ± 0.4, both p < 0.001 versus baseline. Baseline utilities and changes (95% confidence interval) after 2 years of CPAP therapy were EuroQol 5-dimensions 0.79 ± 0.01, 0.02 (0.00-0.05, p = 0.064); short-form 6-dimension medical outcome questionnaire 0.72 ± 0.01, 0.06 (0.04-0.08, p < 0.001); Euro-thermometer visual analog scale 0.70 ± 0.01, 0.09 (0.07-0.12, p < 0.001); time trade-off 0.82 ± 0.01, 0.03 (0.01-0.06, p = 0.002); and standard gamble 0.82 ± 0.01, -0.01 (-0.03 to 0.02, p = 0.712). CONCLUSION The short-form 6-dimensions questionnaire, the Euro-thermometer, and the time trade-off instruments reflected the major clinical improvements in OSAS, while the EuroQoL 5-dimensions and standard gamble tests were not sensitive to CPAP effects. These results indicate that the evaluation of utility of a treatment for OSAS depends critically on the instrument used, which is important from an individual and societal perspective.",2021,"Baseline utilities and changes (95% confidence interval) after 2 years of CPAP therapy were EuroQol 5-dimensions 0.79 ± 0.01, 0.02 (0.00-0.05, p = 0.064); short-form 6-dimension medical outcome questionnaire 0.72 ± 0.01, 0.06 (0.04-0.08, p < 0.001); Euro-thermometer visual analog scale 0.70 ± 0.01, 0.09 (0.07-0.12, p < 0.001); time trade-off 0.82 ± 0.01, 0.03 (0.01-0.06, p = 0.002); and standard gamble 0.82 ± 0.01, -0.01 (-0.03 to 0.02, p = 0.712). ","['Patients with Obstructive Sleep Apnea Syndrome', 'patients with OSAS undergoing continuous positive airway pressure (CPAP) therapy', 'Data of 208 patients with OSAS (28 women, mean ± SE age 54.4 ± 0.7 years, apnea-hypopnea index (AHI) 51.9 ± 1.8/h, Epworth sleepiness score 13.4 ± 0.2) participating in a randomized trial of different CPAP modalities over 2 years were analyzed', 'patients with obstructive sleep apnea syndrome (OSAS']",['Undergoing Continuous Positive Airway Pressure Therapy'],"['sleep studies, Epworth sleepiness scale, and several utility instruments that measure subjective health preference on a scale ranging from 1 (most preferred and perfect health) to 0 (least preferred and very poor health']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4517558', 'cui_str': '13.4'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2936631', 'cui_str': 'Subjective Health Complaint'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]",208.0,0.0254391,"Baseline utilities and changes (95% confidence interval) after 2 years of CPAP therapy were EuroQol 5-dimensions 0.79 ± 0.01, 0.02 (0.00-0.05, p = 0.064); short-form 6-dimension medical outcome questionnaire 0.72 ± 0.01, 0.06 (0.04-0.08, p < 0.001); Euro-thermometer visual analog scale 0.70 ± 0.01, 0.09 (0.07-0.12, p < 0.001); time trade-off 0.82 ± 0.01, 0.03 (0.01-0.06, p = 0.002); and standard gamble 0.82 ± 0.01, -0.01 (-0.03 to 0.02, p = 0.712). ","[{'ForeName': 'Fabienne L', 'Initials': 'FL', 'LastName': 'Huber', 'Affiliation': 'Department of Respiratory Medicine, Sleep Disorders Center, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Furian', 'Affiliation': 'Department of Respiratory Medicine, Sleep Disorders Center, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Kohler', 'Affiliation': 'Department of Respiratory Medicine, Sleep Disorders Center, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Tsogyal D', 'Initials': 'TD', 'LastName': 'Latshang', 'Affiliation': 'Department of Respiratory Medicine, Sleep Disorders Center, Cantonal Hospital Chur, Chur, Switzerland.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Nussbaumer-Ochsner', 'Affiliation': 'Department of Internal Medicine, Cantonal Hospital Schaffhausen, Schaffhausen, Switzerland.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Turk', 'Affiliation': 'Department of Internal Medicine, See-Spital, Horgen, Switzerland.'}, {'ForeName': 'Otto D', 'Initials': 'OD', 'LastName': 'Schoch', 'Affiliation': 'Department of Respiratory Medicine, Center for Sleep Medicine, Cantonal Hospital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Laube', 'Affiliation': 'Department of Respiratory Medicine, Sleep Disorders Center, Triemli Hospital, Zurich, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Thurnheer', 'Affiliation': 'Department of Respiratory Medicine, Sleep Disorders Center, Cantonal Hospital Münsterlingen, Münsterlingen, Switzerland.'}, {'ForeName': 'Konrad E', 'Initials': 'KE', 'LastName': 'Bloch', 'Affiliation': 'Department of Respiratory Medicine, Sleep Disorders Center, University Hospital Zurich, Zurich, Switzerland, konrad.bloch@usz.ch.'}]",Respiration; international review of thoracic diseases,['10.1159/000513306'] 2025,33540298,"The effect on gastrointestinal system functions, pain and anxiety of acupressure applied following laparoscopic cholecystectomy operation: A randomised, placebo-controlled study.","The aim of this randomised, placebo-controlled, 3-way blinded study was to determine the effect on GIS symptoms, pain and anxiety of acupressure applied for a total of 12 min, as 3 min at each of the ST25, CV12, TH6, and HT7 acupuncture points, at 0, 4 and 8 h after laparoscopic cholecystectomy operation. The research data were collected using a patient data collection form, the Numeric Pain Intensity Scale and the State-Trait Anxiety Inventory. The patients were evaluated in respect of the time to first flatus and defecation, pain and the State-Trait Anxiety points at 0, 4, and 8 h postoperatively. The application of acupressure was determined to have signficantly reduced acute postoperative pain and shortened the time to defecation (p < 0.05). The application of acupressure can be recommended in the nursing interventions following laparoscopic cholecystectomy to reduce acute pain and shorten the time to defecation.",2021,The application of acupressure was determined to have signficantly reduced acute postoperative pain and shortened the time to defecation (p < 0.05).,[],"['laparoscopic cholecystectomy operation', 'placebo', 'acupressure']","['acute postoperative pain', 'gastrointestinal system functions, pain and anxiety of acupressure', 'Numeric Pain Intensity Scale and the State-Trait Anxiety Inventory', 'GIS symptoms, pain and anxiety of acupressure', 'time to first flatus and defecation, pain and the State-Trait Anxiety points']",[],"[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}]","[{'cui': 'C2215257', 'cui_str': 'Acute postoperative pain'}, {'cui': 'C0012240', 'cui_str': 'Structure of digestive system'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0815319', 'cui_str': 'Geographical Information Systems'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C1301808', 'cui_str': 'State'}]",,0.05456,The application of acupressure was determined to have signficantly reduced acute postoperative pain and shortened the time to defecation (p < 0.05).,"[{'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Soylu', 'Affiliation': 'Erciyes University, Institute of Health Sciences, Surgical Nursing, Kayseri, Turkey. Electronic address: dsoylu@ksu.edu.tr.'}, {'ForeName': 'Pınar', 'Initials': 'P', 'LastName': 'Tekinsoy Kartın', 'Affiliation': 'Erciyes University, Faculty of Health Sciences, Nursing Department, Kayseri, Turkey. Electronic address: ptekinsoy@erciyes.edu.tr.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101304'] 2026,33504555,Long-Term Follow-up of a Phase III Study of ch14.18 (Dinutuximab) + Cytokine Immunotherapy in Children with High-Risk Neuroblastoma: COG Study ANBL0032.,"PURPOSE Previously our randomized phase III trial demonstrated that immunotherapy including dinutuximab, a chimeric anti-GD2 mAb, GM-CSF, and IL2 improved survival for children with high-risk neuroblastoma that had responded to induction and consolidation therapy. These results served as the basis for FDA approval of dinutuximab. We now present long-term follow-up results and evaluation of predictive biomarkers. PATIENTS AND METHODS Patients recieved six cycles of isotretinoin with or without five cycles of immunotherapy which consists of dinutuximab with GM-CSF alternating with IL2. Accrual was discontinued early due to meeting the protocol-defined stopping rule for efficacy, as assessed by 2-year event-free survival (EFS). Plasma levels of dinutuximab, soluble IL2 receptor (sIL2R), and human anti-chimeric antibody (HACA) were assessed by ELISA. Fcγ receptor 2A and 3A genotypes were determined by PCR and direct sequencing. RESULTS For 226 eligible randomized patients, 5-year EFS was 56.6 ± 4.7% for patients randomized to immunotherapy ( n = 114) versus 46.1 ± 5.1% for those randomized to isotretinoin only ( n = 112; P = 0.042). Five-year overall survival (OS) was 73.2 ± 4.2% versus 56.6 ± 5.1% for immunotherapy and isotretinoin only patients, respectively ( P = 0.045). Thirteen of 122 patients receiving dinutuximab developed HACA. Plasma levels of dinutuximab, HACA, and sIL2R did not correlate with EFS/OS, or clinically significant toxicity. Fcγ receptor 2A and 3A genotypes did not correlate with EFS/OS. CONCLUSIONS Immunotherapy with dinutuximab improved outcome for patients with high-risk neuroblastoma. Early stoppage for efficacy resulted in a smaller sample size than originally planned, yet clinically significant long-term differences in survival were observed.",2021,"Plasma levels of dinutuximab, HACA, and sIL2R did not correlate with EFS/OS, or clinically significant toxicity.","['Children with High-risk Neuroblastoma', 'patients with high-risk neuroblastoma', '226 eligible randomized patients, 5-year EFS was', 'children with high-risk neuroblastoma', 'Thirteen of 122 patients receiving dinutuximab developed HACA']","['isotretinoin with or without 5 cycles of immunotherapy which consists of dinutuximab with GM-CSF alternating with IL2', 'ch14.18 (Dinutuximab) + Cytokine Immunotherapy', 'immunotherapy']","['Plasma levels of dinutuximab, soluble IL2 receptor (sIL2R) and human anti-chimeric antibody (HACA', 'survival', '2-year event-free survival (EFS', 'overall survival (OS', 'Plasma levels of dinutuximab, HACA, and sIL2R']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0027819', 'cui_str': 'Neuroblastoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0281581', 'cui_str': 'dinutuximab'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0008109', 'cui_str': 'Chimera'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]","[{'cui': 'C0022265', 'cui_str': 'Isotretinoin'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0281581', 'cui_str': 'dinutuximab'}, {'cui': 'C0018183', 'cui_str': 'Granulocyte'}, {'cui': 'C0079784', 'cui_str': 'Colony-stimulating factor, macrophage'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0281581', 'cui_str': 'dinutuximab'}, {'cui': 'C0487019', 'cui_str': 'Interleukin 2 receptor, soluble'}, {'cui': 'C0034819', 'cui_str': 'Interleukin-2 receptor'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0008109', 'cui_str': 'Chimera'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",226.0,0.0773798,"Plasma levels of dinutuximab, HACA, and sIL2R did not correlate with EFS/OS, or clinically significant toxicity.","[{'ForeName': 'Alice L', 'Initials': 'AL', 'LastName': 'Yu', 'Affiliation': 'University of California in San Diego, San Diego, California. a1yu@ucsd.edu pmsondel@humonc.wisc.edu.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Gilman', 'Affiliation': 'PRA Health Services, Raleigh, North Carolina.'}, {'ForeName': 'M Fevzi', 'Initials': 'MF', 'LastName': 'Ozkaynak', 'Affiliation': 'New York Medical College, Valhalla, New York.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Naranjo', 'Affiliation': ""Children's Oncology Group Statistics and Data Center, University of Florida, Gainesville, Florida.""}, {'ForeName': 'Mitchell B', 'Initials': 'MB', 'LastName': 'Diccianni', 'Affiliation': 'University of California in San Diego, San Diego, California.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Gan', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, Wisconsin.'}, {'ForeName': 'Jacquelyn A', 'Initials': 'JA', 'LastName': 'Hank', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, Wisconsin.'}, {'ForeName': 'Ayse', 'Initials': 'A', 'LastName': 'Batova', 'Affiliation': 'University of California in San Diego, San Diego, California.'}, {'ForeName': 'Wendy B', 'Initials': 'WB', 'LastName': 'London', 'Affiliation': ""Dana-Farber/Boston Children's Cancer and Blood Disorder Center, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Sheena C', 'Initials': 'SC', 'LastName': 'Tenney', 'Affiliation': ""Children's Oncology Group Statistics and Data Center, University of Florida, Gainesville, Florida.""}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Smith', 'Affiliation': 'National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Barry L', 'Initials': 'BL', 'LastName': 'Shulkin', 'Affiliation': ""Saint Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Parisi', 'Affiliation': ""Seattle Children's Hospital and University of Washington School of Medicine, Seattle, Washington.""}, {'ForeName': 'Katherine K', 'Initials': 'KK', 'LastName': 'Matthay', 'Affiliation': ""University of California School of Medicine and UCSF Children's Hospital, San Francisco, California.""}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Cohn', 'Affiliation': 'University of Chicago, Chicago, Illinois.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Maris', 'Affiliation': ""Children's Hospital of Philadelphia and University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.""}, {'ForeName': 'Rochelle', 'Initials': 'R', 'LastName': 'Bagatell', 'Affiliation': ""Children's Hospital of Philadelphia and University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.""}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Park', 'Affiliation': ""Seattle Children's Hospital and University of Washington School of Medicine, Seattle, Washington.""}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Sondel', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, Wisconsin. a1yu@ucsd.edu pmsondel@humonc.wisc.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-3909'] 2027,33506907,Application of simulated puncture in percutaneous nephrolithotomy.,"OBJECTIVE This study aimed to explore the clinical value of simulated puncture in percutaneous nephrolithotomy in the treatment of complex kidney stones. PATIENTS AND METHODS A total of 120 patients with complex kidney stones who were treated with percutaneous nephrolithotomy in our hospital between March 2017 and March 2020 were enrolled in this study and randomly divided into two groups: the research group and the control group (n = 60 in each). Each subject underwent a dual-source computed tomography (CT) scan of the pelvis and both kidneys before the operation. The research team imported the CT data into Mimics19 software to create a three-dimensional (3D) reconstruction of the skin, bones, kidneys, collecting system, and stones. Based on the 3D reconstruction model, the target renal calyx to be punctured was determined, the best puncture channel was designed, and puncture was simulated. Data regarding the simulated puncture were imported into 3-Matics11 software; the angle and depth of the puncture were measured, and then these data were used to guide percutaneous nephrolithotomy. 3D reconstruction and simulated puncture were not undertaken for the patients in the control group before the operation. The effects of treatment in the two groups were compared. RESULTS First-stage percutaneous nephrolithotomy was successfully completed in both groups of patients. The outcome was better in the research group than in the control group in terms of operation time, number of punctures required for successful establishment of a percutaneous renal channel, number of percutaneous kidney puncture channels, and intraoperative blood loss, and the differences were statistically significant (p < 0.05 for all). The stone clearance rate was higher in the research group than in the control group, but the difference was not statistically significant (p = 0.471). The incidence of penetrating kidney injury was lower in the research group than in the control group, but the difference was not statistically significant (p = 0.154). CONCLUSIONS For patients due to undergo percutaneous nephrolithotomy for the treatment of complex kidney stones, preoperative simulated puncture helps to improve the puncture accuracy and to reduce the number of punctures required for successful establishment of a percutaneous renal channel, the number of puncture channels, the operation time, and the blood loss, and therefore it is worth promoting.",2021,"The outcome was better in the research group than in the control group in terms of operation time, number of punctures required for successful establishment of a percutaneous renal channel, number of percutaneous kidney puncture channels, and intraoperative blood loss, and the differences were statistically significant (p < 0.05 for all).","['in our hospital between March 2017 and March 2020', 'percutaneous nephrolithotomy', '120 patients with complex kidney stones who were treated with']","['percutaneous nephrolithotomy', 'dual-source computed tomography (CT) scan']","['operation time, number of punctures required for successful establishment of a percutaneous renal channel, number of percutaneous kidney puncture channels, and intraoperative blood loss', 'incidence of penetrating kidney injury', 'stone clearance rate']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0160420', 'cui_str': 'Injury of kidney'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}]",120.0,0.0257234,"The outcome was better in the research group than in the control group in terms of operation time, number of punctures required for successful establishment of a percutaneous renal channel, number of percutaneous kidney puncture channels, and intraoperative blood loss, and the differences were statistically significant (p < 0.05 for all).","[{'ForeName': 'Y-S', 'Initials': 'YS', 'LastName': 'Huang', 'Affiliation': ""Department of Urology, The People's Hospital of Jiangxi Province (The People's Hospital of Nanchang University), Nanchang, China. huamghaipemg@21cn.com.""}, {'ForeName': 'X-S', 'Initials': 'XS', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'G-Y', 'Initials': 'GY', 'LastName': 'Wan', 'Affiliation': ''}, {'ForeName': 'Z-W', 'Initials': 'ZW', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'H-P', 'Initials': 'HP', 'LastName': 'Huang', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_202101_24384'] 2028,33512442,A phase 3 double-blind study of the addition of tocilizumab vs placebo to cyclosporin/methotrexate GVHD prophylaxis.,"We determined the efficacy of tocilizumab (TCZ) in preventing grade 2-4 acute graft-versus-host disease (aGVHD) in patients with acute leukemia or myelodysplasia undergoing matched sibling donor (MSD) or volunteer unrelated donor (VUD) allogeneic stem cell transplantation after myeloablative or reduced-intensity conditioning across 5 Australian centers. A total of 145 patients (50 MSD, 95 VUD) were randomly assigned to placebo or TCZ on day -1. All patients received T-cell-replete peripheral blood stem cell grafts and graft-versus-host disease (GVHD) prophylaxis with cyclosporin/methotrexate. A planned substudy analyzed the VUD cohort. With a median follow-up of 746 days, the incidence of grade 2-4 aGVHD at day 100 for the entire cohort was 36% for placebo vs 27% for TCZ (hazard ratio [HR], 0.69; 95% confidence interval [CI], 0.38-1.26; P = .23) and 45% vs 32% (HR, 0.61; 95% CI, 0.31-1.22; P = .16) for the VUD subgroup. The incidence of grade 2-4 aGVHD at day 180 for the entire cohort was 40% for placebo vs 29% for TCZ (HR, 0.68; 95% CI, 0.38-1.22; P = .19) and 48% vs 32% (HR, 0.59; 95% CI, 0.30-1.16; P = .13) for the VUD subgroup. Reductions in aGVHD were predominantly in grade 2 disease. For the entire cohort, transplant-related mortality occurred in 8% vs 11% of placebo-treated vs TCZ-treated patients, respectively (P = .56), and overall survival was 79% vs 71% (P = .27). Median day to neutrophil and platelet engraftment was delayed by 2 to 3 days in TCZ-treated patients, whereas liver toxicity and infectious complications were similar between groups. In this phase 3 randomized double-blind trial, TCZ showed nonsignificant trends toward reduced incidence of grade 2-4 aGVHD in recipients from HLA-matched VUDs but no improvements in long term-survival.",2021,"A trend to improved aGVHD-free survival (aGVHD-FS) was noted in the TCZ-treated VUD subgroup, 52% versus 68% for placebo versus TCZ (p=0.13).","['145 patients (50 MSD, 95 VUD', 'patients with acute-leukemia or myelodysplasia undertaking matched-related-sibling (MSD) or volunteer-unrelated-donor (VUD) allogeneic-SCT after myeloablative or reduced-intensity conditioning across five Australian centers']","['placebo', 'placebo or TCZ', 'cyclosporin/methotrexate', 'Cyclosporin/Methotrexate GvHD Prophylaxis', 'tocilizumab (TCZ', 'Tocilizumab versus Placebo', 'tocilizumab', 'TCZ']","['grade II-IV acute GVHD (aGVHD', 'overall-survival', 'liver toxicity and infectious complications', 'mortality', 'incidence of grade II-IV aGVHD and improved aGVHD-FS', 'aGVHD', 'Median day to neutrophil and platelet engraftment', 'incidence of grade II-IV aGVHD', 'aGVHD-free survival (aGVHD-FS']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0268263', 'cui_str': 'Multiple sulfatase deficiency'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C3179133', 'cui_str': 'Donors, Unrelated'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia'}, {'cui': 'C0026985', 'cui_str': 'Myelodysplasia'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0796149', 'cui_str': 'Scott syndrome'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0018133', 'cui_str': 'Graft versus host disease'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",,0.5253,"A trend to improved aGVHD-free survival (aGVHD-FS) was noted in the TCZ-treated VUD subgroup, 52% versus 68% for placebo versus TCZ (p=0.13).","[{'ForeName': 'Glen A', 'Initials': 'GA', 'LastName': 'Kennedy', 'Affiliation': ""Department of Haematology and Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia.""}, {'ForeName': 'Siok-Keen', 'Initials': 'SK', 'LastName': 'Tey', 'Affiliation': ""Department of Haematology and Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia.""}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Buizen', 'Affiliation': 'Melbourne EpiCentre, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Antiopi', 'Initials': 'A', 'LastName': 'Varelias', 'Affiliation': 'School of Medicine, University of Queensland, St Lucia, QLD, Australia.'}, {'ForeName': 'Kate H', 'Initials': 'KH', 'LastName': 'Gartlan', 'Affiliation': 'School of Medicine, University of Queensland, St Lucia, QLD, Australia.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Curley', 'Affiliation': ""Department of Haematology and Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia.""}, {'ForeName': 'Stuart D', 'Initials': 'SD', 'LastName': 'Olver', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia.'}, {'ForeName': 'Karshing', 'Initials': 'K', 'LastName': 'Chang', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia.'}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Butler', 'Affiliation': ""Department of Haematology and Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia.""}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Misra', 'Affiliation': ""Department of Haematology and Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia.""}, {'ForeName': 'Elango', 'Initials': 'E', 'LastName': 'Subramoniapillai', 'Affiliation': ""Department of Haematology and Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia.""}, {'ForeName': 'A James', 'Initials': 'AJ', 'LastName': 'Morton', 'Affiliation': ""Department of Haematology and Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Durrant', 'Affiliation': ""Department of Haematology and Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia.""}, {'ForeName': 'Andrea S', 'Initials': 'AS', 'LastName': 'Henden', 'Affiliation': ""Department of Haematology and Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Moore', 'Affiliation': ""Haematology and Bone Marrow Transplantation, St Vincent's Hospital, Sydney, NSW, Australia.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ritchie', 'Affiliation': 'Clinical Haematology, Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Parkville, VIC, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gottlieb', 'Affiliation': 'Department of Haematology and Bone Marrow Transplantation, Westmead Hospital, Sydney, NSW, Australia; and.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Cooney', 'Affiliation': 'Fiona Stanley Hospital, Murdoch, WA, Australia.'}, {'ForeName': 'Sanjoy K', 'Initials': 'SK', 'LastName': 'Paul', 'Affiliation': 'Melbourne EpiCentre, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Geoffrey R', 'Initials': 'GR', 'LastName': 'Hill', 'Affiliation': ""Department of Haematology and Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia.""}]",Blood,['10.1182/blood.2020009050'] 2029,33512329,Virtual Reality Cognitive Training Among Individuals With Alcohol Use Disorder Undergoing Residential Treatment: Pilot Randomized Controlled Trial.,"BACKGROUND Alcohol use disorder (AUD) has been associated with diverse physical and mental morbidities. Among the main consequences of chronic and excessive alcohol use are cognitive and executive deficits. Some of these deficits may be reversed in specific cognitive and executive domains with behavioral approaches consisting of cognitive training. The advent of computer-based interventions may leverage these improvements, but randomized controlled trials (RCTs) of digital interactive-based interventions are still scarce. OBJECTIVE The aim of this study is to explore whether a cognitive training approach using VR exercises based on activities of daily living is feasible for improving the cognitive function of patients with AUD undergoing residential treatment, as well as to estimate the effect size for this intervention to power future definitive RCTs. METHODS This study consisted of a two-arm pilot RCT with a sample of 36 individuals recovering from AUD in a therapeutic community; experimental group participants received a therapist-guided, VR-based cognitive training intervention combined with treatment as usual, and control group participants received treatment as usual without cognitive training. A comprehensive neuropsychological battery of tests was used both at pre- and postassessments, including measurement of global cognition, executive functions, attention, visual memory, and cognitive flexibility. RESULTS In order to control for potential effects of global cognition and executive functions at baseline, these domains were controlled for in the statistical analysis for each individual outcome. Results indicate intervention effects on attention in two out of five outcomes and on cognitive flexibility in two out of six outcomes, with effect sizes in significant comparisons being larger for attention than for cognitive flexibility. Patient retention in cognitive training was high, in line with previous studies. CONCLUSIONS Overall, the data suggest that VR-based cognitive training results in specific contributions to improving attention ability and cognitive flexibility of patients recovering from AUD. TRIAL REGISTRATION ClinicalTrials.gov NCT04505345; https://clinicaltrials.gov/show/NCT04505345.",2021,"Results indicate intervention effects on attention in two out of five outcomes and on cognitive flexibility in two out of six outcomes, with effect sizes in significant comparisons being larger for attention than for cognitive flexibility.","['36 individuals recovering from AUD in a therapeutic community; experimental group participants received a', 'patients with AUD undergoing residential treatment', 'Individuals With Alcohol Use Disorder Undergoing Residential Treatment', 'patients recovering from AUD']","['Virtual Reality Cognitive Training', 'cognitive training approach using VR exercises', 'therapist-guided, VR-based cognitive training intervention combined with treatment as usual, and control group participants received treatment as usual without cognitive training', 'VR-based cognitive training']","['attention ability and cognitive flexibility', 'global cognition, executive functions, attention, visual memory, and cognitive flexibility', 'cognitive flexibility']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0039786', 'cui_str': 'Community, Therapeutic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035189', 'cui_str': 'Residential Treatment'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0542316', 'cui_str': 'Visual memory'}]",36.0,0.0536769,"Results indicate intervention effects on attention in two out of five outcomes and on cognitive flexibility in two out of six outcomes, with effect sizes in significant comparisons being larger for attention than for cognitive flexibility.","[{'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Gamito', 'Affiliation': 'School of Psychology and Life Sciences, Lusófona University, Lisboa, Portugal.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Oliveira', 'Affiliation': 'School of Psychology and Life Sciences, Lusófona University, Lisboa, Portugal.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Matias', 'Affiliation': 'School of Psychology and Life Sciences, Lusófona University, Lisboa, Portugal.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Cunha', 'Affiliation': 'School of Psychology and Life Sciences, Lusófona University, Lisboa, Portugal.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Brito', 'Affiliation': 'Digital Human-Environment Interaction Lab, Lusófona University, Lisboa, Portugal.'}, {'ForeName': 'Paulo Ferreira', 'Initials': 'PF', 'LastName': 'Lopes', 'Affiliation': 'School of Psychology and Life Sciences, Lusófona University, Lisboa, Portugal.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Deus', 'Affiliation': 'Casa de Saúde do Telhal, Instituto São João de Deus, Sintra, Portugal.'}]",Journal of medical Internet research,['10.2196/18482'] 2030,33509742,A clinicobiochemical evaluation of curcumin as gel and as buccal mucoadhesive patches in the management of oral submucous fibrosis.,"OBJECTIVE The objective of this study was to evaluate and compare the efficacy of topical curcumin gel and buccal mucoadhesive patches in the management of oral submucous fibrosis (OSMF). STUDY DESIGN Forty patients clinically diagnosed with OSMF were randomly divided into 2 groups. Group A received curcumin gel and group B received curcumin mucoadhesive patches, to be used twice daily for 8 weeks. Evaluation was done every 2 weeks. Serum lactate dehydrogenase (LDH) levels were measured before and after treatment and also in 20 healthy controls. RESULTS A 100% reduction in burning sensation was observed in all 40 patients at the end of 4 weeks. Mouth opening improved by 5.45 ± 1.64 mm in group A and 5.9 ± 2.00 mm in group B. Pretreatment LDH was 359.72 ± 77.02 IU/L in patients with OSMF, which was significantly higher than that in healthy volunteers (173.2 ± 46.20 IU/L). In group A, LDH values reduced from 341.85 ± 71 IU/L to 264.95 ± 65.09 IU/L and in group B, values reduced from 377.6 ± 79.76 IU/L to 286.15 ± 72.95 IU/L after treatment. CONCLUSION Curcumin gel and mucoadhesive patches were effective in improving mouth opening and reducing burning sensation in patients with OSMF. They can therefore be considered as safe, noninvasive modalities for treatment of OSMF.",2021,Curcumin gel and mucoadhesive patches were effective in improving mouth opening and reducing burning sensation in patients with OSMF.,"['oral submucous fibrosis', 'patients with OSMF', '20 healthy controls', 'Forty patients clinically diagnosed with OSMF']","['Curcumin gel and mucoadhesive patches', 'topical curcumin gel and buccal mucoadhesive patches', 'curcumin gel and group B received curcumin mucoadhesive patches']","['burning sensation', 'mouth opening and reducing burning sensation', 'Serum lactate dehydrogenase (LDH) levels', 'LDH values', 'Mouth opening']","[{'cui': 'C0029172', 'cui_str': 'Oral submucosal fibrosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C0085624', 'cui_str': 'Burning sensation'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1278052', 'cui_str': 'Serum lactate dehydrogenase measurement'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",40.0,0.059342,Curcumin gel and mucoadhesive patches were effective in improving mouth opening and reducing burning sensation in patients with OSMF.,"[{'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Chandrashekar', 'Affiliation': 'Post graduate, Department of Oral Medicine and Radiology, College of Dental Sciences, Davangere, Karnataka, India. Electronic address: Aditi212121@gmail.com.'}, {'ForeName': 'Rajeshwari G', 'Initials': 'RG', 'LastName': 'Annigeri', 'Affiliation': 'Professor and Head, Department of Oral Medicine and Radiology, College of Dental Sciences, Davangere, Karnataka, India.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Va', 'Affiliation': 'Reader, Department of Oral Medicine and Radiology, College of Dental Sciences, Davangere, Karnataka, India.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Thimmasetty', 'Affiliation': 'Professor, Bapuji Pharmacy College, Davangere, Karnataka, India.'}]","Oral surgery, oral medicine, oral pathology and oral radiology",['10.1016/j.oooo.2020.12.020'] 2031,33514377,Letter to the editor: Modified Stoppa as an alternative surgical approach for fixation of anterior fracture acetabulum: a randomized control clinical trial.,,2021,,[],[],[],[],[],[],,0.0318889,,"[{'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Khalifa', 'Affiliation': 'Orthopaedic and Traumatolgy Department, Qena Faculty of Medicine and University Hospital, South Valley University, Qena, Egypt. ahmed_adel0391@med.svu.edu.eg.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-021-02231-w'] 2032,33520191,The effect of two clinical criteria in the assessment of caries lesions around restorations in children (CARDEC-03): study protocol for a diagnostic randomized clinical trial.,"Introduction: The detection of caries lesions around restoration can be challenging. Therefore, the use of some criteria has been proposed in order to give more objectivity to the diagnosis process. Two of them are the International Dental Federation (FDI) and the Caries Associated with Restorations and Sealants (CARS) criteria. Both methods have a different approach to caries, and it is not possible to know which one of them is the best to use in clinical practice to assess restorations in children. Thus, the present protocol aims to evaluate the effect of the use of the FDI and CARS criteria in the assessment of caries lesions around restorations in primary teeth on outcomes related to oral health in children and costs resulting from the assessments. Methods and analysis: A total of 626 restorations of children from three to 10 years were randomly assessed and are being treated following the FDI criteria (FDI group) or CARS criteria (CARS group). Participants will be followed-up after six, 12, 18, and 24 months. The primary outcome will be the need for a new intervention in the evaluated restorations. This outcome consists of several components, and each of these events will be analyzed separately as secondary outcomes. The changes in children's oral health-related quality of life and the cost of the restoration dental treatments will also be analyzed as secondary outcomes. The methods will be compared using the Cox regression model with shared frailty. A significance level of 5% will be adopted for all statistical analyses. Discussion: This will be the first randomized clinical study carried out regarding the detection of caries lesions around restorations in primary teeth. Trial registration: The study underwent registration in Clinicaltrials.gov ( NCT03520309) on 9 May 2018.",2020,The changes in children's oral health-related quality of life and the cost of the restoration dental treatments will also be analyzed as secondary outcomes.,"['children', 'Two of them are the International Dental Federation (FDI) and the Caries Associated with Restorations and Sealants (CARS) criteria', '626 restorations of children from three to 10 years were randomly assessed and are being treated following the FDI criteria (FDI group) or CARS criteria (CARS group', 'caries lesions around restorations in primary teeth', 'caries lesions around restorations in children (CARDEC-03']",[],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004381', 'cui_str': 'Automobile'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}]",[],[],,0.102531,The changes in children's oral health-related quality of life and the cost of the restoration dental treatments will also be analyzed as secondary outcomes.,"[{'ForeName': 'Bruna Lorena Pereira', 'Initials': 'BLP', 'LastName': 'Moro', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Cácia', 'Initials': 'C', 'LastName': 'Signori', 'Affiliation': 'Graduate Program in Dentistry, Federal University of Pelotas, Pelotas, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Raiza Dias', 'Initials': 'RD', 'LastName': 'Freitas', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Laura Regina Antunes', 'Initials': 'LRA', 'LastName': 'Pontes', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Tathiane Larissa', 'Initials': 'TL', 'LastName': 'Lenzi', 'Affiliation': 'Department of Surgery and Orthopedics, School of Dentistry, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Tamara Kerber', 'Initials': 'TK', 'LastName': 'Tedesco', 'Affiliation': 'Graduate Program in Dentistry, Ibirapuera University, São Paulo, Brazil.'}, {'ForeName': 'Daniela Prócida', 'Initials': 'DP', 'LastName': 'Raggio', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Mariana Minatel', 'Initials': 'MM', 'LastName': 'Braga', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Kim Rud', 'Initials': 'KR', 'LastName': 'Ekstrand', 'Affiliation': 'Department of Odontology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Maximiliano Sérgio', 'Initials': 'MS', 'LastName': 'Cenci', 'Affiliation': 'Graduate Program in Dentistry, Federal University of Pelotas, Pelotas, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Fausto Medeiros', 'Initials': 'FM', 'LastName': 'Mendes', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",F1000Research,['10.12688/f1000research.23801.3'] 2033,33518473,"Prevalence, clinical determinants and prognostic implications of coronary procedural complications of percutaneous coronary intervention in non-ST-segment elevation myocardial infarction: Insights from the contemporary multinational TAO trial.","BACKGROUND Few data are available on procedural complications of percutaneous coronary intervention (PCI) in the setting of acute coronary syndrome in the contemporary era. AIM We sought to describe the prevalence of procedural complications of PCI in a non-ST-segment elevation acute coronary syndrome (NSTE ACS) cohort, and to identify their clinical characteristics and association with clinical outcomes. METHODS Patients randomized in TAO (Treatment of Acute coronary syndrome with Otamixaban), an international randomized controlled trial (ClinicalTrials.gov Identifier: NCT01076764) that compared otamixaban with unfractionated heparin plus eptifibatide in patients with NSTE ACS who underwent PCI, were included in the analysis. Procedural complications were collected prospectively, categorized and adjudicated by a blinded Clinical Events Committee, with review of angiograms. A multivariable model was constructed to identify independent clinical characteristics associated with procedural complications. RESULTS A total of 8656 patients with NSTE ACS who were enrolled in the TAO trial underwent PCI, and 451 (5.2%) experienced at least one complication. The most frequent complications were no/slow reflow (1.5%) and dissection with decreased flow (1.2%). Procedural complications were associated with the 7-day ischaemic outcome of death, myocardial infarction or stroke (24.2% vs. 6.0%, odds ratio 5.01, 95% confidence interval 3.96-6.33; P<0.0001) and with Thrombolysis In Myocardial Infarction major and minor bleeding (6.2% vs. 2.3%, odds ratio 2.79, 95% confidence interval 1.86-4.2; P<0.0001). Except for previous coronary artery bypass grafting, multivariable analysis did not identify preprocedural clinical predictors of complications. CONCLUSIONS In a contemporary NSTE ACS population, procedural complications with PCI remain frequent, are difficult to predict based on clinical characteristics, and are associated with worse ischaemic and haemorrhagic outcomes.",2021,"Procedural complications were associated with the 7-day ischaemic outcome of death, myocardial infarction or stroke (24.2% vs. 6.0%, odds ratio 5.01, 95% confidence interval 3.96-6.33; P<0.0001) and with Thrombolysis","['8656 patients with NSTE ACS who were enrolled in the TAO trial underwent PCI, and 451 (5.2%) experienced at least one complication', 'patients with NSTE ACS who underwent PCI, were included in the analysis', 'non-ST-segment elevation myocardial infarction', 'Patients randomized in TAO (Treatment of Acute coronary syndrome with Otamixaban']","['percutaneous coronary intervention', 'percutaneous coronary intervention (PCI', 'otamixaban with unfractionated heparin plus eptifibatide', 'Thrombolysis']","['Myocardial Infarction major and minor bleeding', '7-day ischaemic outcome of death, myocardial infarction or stroke', 'Procedural complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3160886', 'cui_str': 'Non ST segment elevation acute coronary syndrome'}, {'cui': 'C0040021', 'cui_str': 'Thromboangiitis obliterans'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C5191282', 'cui_str': '451'}, {'cui': 'C4517790', 'cui_str': '5.2'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1536221', 'cui_str': 'Non ST segment elevation myocardial infarction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C1097497', 'cui_str': 'otamixaban'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1097497', 'cui_str': 'otamixaban'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0253563', 'cui_str': 'eptifibatide'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}]","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1141861', 'cui_str': 'Procedural complication'}]",8656.0,0.306243,"Procedural complications were associated with the 7-day ischaemic outcome of death, myocardial infarction or stroke (24.2% vs. 6.0%, odds ratio 5.01, 95% confidence interval 3.96-6.33; P<0.0001) and with Thrombolysis","[{'ForeName': 'Jeremie', 'Initials': 'J', 'LastName': 'Abtan', 'Affiliation': 'FACT (an F-CRIN network), DHU-FIRE, Hôpital Bichat, AP-HP, 75018 Paris, France; Université Paris-Diderot, Sorbonne Paris Cité, 75013 Paris, France; Inserm U1148, 75877 Paris, France. Electronic address: jeremie.abtan@aphp.fr.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, 02115 Boston, MA, USA.""}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Sorbets', 'Affiliation': 'Hôpital Avicenne, Université Paris 13, AP-HP, 93000 Bobigny, France.'}, {'ForeName': 'Batric', 'Initials': 'B', 'LastName': 'Popovic', 'Affiliation': 'Cardiology Department, CHRU Nancy, 54000 Nancy, France.'}, {'ForeName': 'Yedid', 'Initials': 'Y', 'LastName': 'Elbez', 'Affiliation': 'FACT (an F-CRIN network), DHU-FIRE, Hôpital Bichat, AP-HP, 75018 Paris, France; Université Paris-Diderot, Sorbonne Paris Cité, 75013 Paris, France; Inserm U1148, 75877 Paris, France.'}, {'ForeName': 'Shamir R', 'Initials': 'SR', 'LastName': 'Mehta', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, McMaster University, L8N 3Z5 Hamilton, ON, Canada.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, 02115 Boston, MA, USA.""}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Bode', 'Affiliation': 'Medizinische Universitatsklinik, 79106 Freiburg, Germany.'}, {'ForeName': 'Charles V', 'Initials': 'CV', 'LastName': 'Pollack', 'Affiliation': 'Department of Emergency Medicine, Thomas-Jefferson University Hospital and Sidney Kimmel Medical College, Thomas-Jefferson University, 19107 Philadelphia, PA, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Cohen', 'Affiliation': 'Division of Cardiology, Newark Beth Israel Medical Center, Mount-Sinai School of Medicine, 07112 Newark, NJ, USA.'}, {'ForeName': 'Tiziano', 'Initials': 'T', 'LastName': 'Moccetti', 'Affiliation': 'Division of Cardiology, Fondazione Cardiocentro Ticino, 6900 Lugano, Switzerland.'}, {'ForeName': 'Peep', 'Initials': 'P', 'LastName': 'Laanmets', 'Affiliation': 'North Estonia Medical Centre, 13419 Tallinn, Estonia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Faxon', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, 02115 Boston, MA, USA.""}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Okreglicki', 'Affiliation': 'Faculty of Health Sciences, Hatter Institute for Cardiovascular Research in Africa & IIDMM, University of Cape Town, 7935 Cape Town, South Africa.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Ducrocq', 'Affiliation': 'FACT (an F-CRIN network), DHU-FIRE, Hôpital Bichat, AP-HP, 75018 Paris, France; Université Paris-Diderot, Sorbonne Paris Cité, 75013 Paris, France; Inserm U1148, 75877 Paris, France.'}, {'ForeName': 'Ph Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'FACT (an F-CRIN network), DHU-FIRE, Hôpital Bichat, AP-HP, 75018 Paris, France; Université Paris-Diderot, Sorbonne Paris Cité, 75013 Paris, France; Inserm U1148, 75877 Paris, France; NLHI, ICMS, Royal Brompton Hospital, Imperial College, SW3 6LY London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Archives of cardiovascular diseases,['10.1016/j.acvd.2020.09.005'] 2034,33518452,Hyperbaric oxygen therapy to prevent central airway stenosis after lung transplantation.,"BACKGROUND Central airway stenosis (CAS) is a severe airway complication after lung transplantation associated with bronchial ischemia and necrosis. We sought to determine whether hyperbaric oxygen therapy (HBOT), an established treatment for tissue ischemia, attenuates post-transplant bronchial injury. METHODS We performed a randomized, controlled trial comparing usual care with HBOT (2 atm absolute for 2 hours × 20 sessions) in subjects with extensive airway necrosis 4 weeks after transplantation. Endobronchial biopsies were collected at 4, 7, and 10 weeks after transplantation for a quantitative polymerase chain reaction. Coprimary outcomes were incidence of airway stenting and acute cellular rejection (ACR) at 1 year. RESULTS The trial was stopped after enrolling 20 subjects (n = 10 per group) after a pre-planned interim analysis showed no difference between usual care and HBOT groups in stenting (both 40%), ACR (70% and 40%, respectively), or CAS (40% and 60%, respectively). Time to first stent placement (median [interquartile range]) was significantly shorter in the HBOT group (150 [73-150] vs 186 [167-206] days, p < 0.05). HIF gene expression was significantly increased in donor tissues at 4, 7, and 10 weeks after transplantation but was not altered by HBOT. Subjects who developed CAS or required stenting had significantly higher HMOX1 and VEGFA expression at 4 weeks (both p < 0.05). Subjects who developed ACR had significant FLT1, TIE2, and KDR expression at 4 weeks (all p < 0.05). CONCLUSIONS Incidence of CAS is high after severe, established airway necrosis after transplantation. HBOT does not reduce CAS severity or stenting. Elevated HMOX1 and VEGFA expressions appear to associate with airway complications.",2021,Subjects who developed CAS or required stenting had significantly higher HMOX1 and VEGFA expression at 4 weeks (both p < 0.05).,"['central airway stenosis after lung transplantation', 'subjects with extensive airway necrosis 4 weeks after transplantation']","['hyperbaric oxygen therapy (HBOT', 'HBOT', 'usual care with HBOT', 'Hyperbaric oxygen therapy']","['FLT1, TIE2, and KDR expression', 'HMOX1 and VEGFA expression', 'CAS severity or stenting', 'incidence of airway stenting and acute cellular rejection (ACR', 'Elevated HMOX1 and VEGFA expressions', 'HIF gene expression']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0024128', 'cui_str': 'Transplant of lung'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}]","[{'cui': 'C1568520', 'cui_str': 'FLT1 protein, human'}, {'cui': 'C3849882', 'cui_str': 'vascular endothelial growth factor receptor-2, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0538674', 'cui_str': 'Hemeoxygenase 1'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0877453', 'cui_str': 'Acute cellular rejection'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}]",20.0,0.125738,Subjects who developed CAS or required stenting had significantly higher HMOX1 and VEGFA expression at 4 weeks (both p < 0.05).,"[{'ForeName': 'Bryan D', 'Initials': 'BD', 'LastName': 'Kraft', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine; Center for Hyperbaric Medicine and Environmental Physiology, Department of Anesthesiology, Duke University School of Medicine, Durham, North Carolina. Electronic address: bryan.kraft@duke.edu.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Mahmood', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine.'}, {'ForeName': 'Nicole P', 'Initials': 'NP', 'LastName': 'Harlan', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine; Center for Hyperbaric Medicine and Environmental Physiology, Department of Anesthesiology, Duke University School of Medicine, Durham, North Carolina; Division of Pulmonary and Critical Care Medicine, Department of Medicine, Dartmouth-Hitchcock, Lebanon, New Hampshire.'}, {'ForeName': 'Matthew G', 'Initials': 'MG', 'LastName': 'Hartwig', 'Affiliation': 'Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Laurie D', 'Initials': 'LD', 'LastName': 'Snyder', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine.'}, {'ForeName': 'Hagir B', 'Initials': 'HB', 'LastName': 'Suliman', 'Affiliation': 'Center for Hyperbaric Medicine and Environmental Physiology, Department of Anesthesiology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Scott L', 'Initials': 'SL', 'LastName': 'Shofer', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2021.01.008'] 2035,33821797,The role of oxytocin in delay of gratification and flexibility in non-social decision making.,"Oxytocin is well-known for its impact on social cognition. This specificity for the social domain, however, has been challenged by findings suggesting a domain-general allostatic function for oxytocin by promoting future-oriented and flexible behavior. In this pre-registered study, we tested the hypothesized domain-general function of oxytocin by assessing the impact of intranasal oxytocin (24 IU) on core aspects of human social (inequity aversion) and non-social decision making (delay of gratification and cognitive flexibility) in 49 healthy volunteers (within-subject design). In intertemporal choice, patience was higher under oxytocin than under placebo, although this difference was evident only when restricting the analysis to the first experimental session (between-group comparison) due to carry-over effects. Further, oxytocin increased cognitive flexibility in reversal learning as well as generosity under conditions of advantageous but not disadvantageous inequity. Our findings show that oxytocin affects both social and non-social decision making, supporting theoretical accounts of domain-general functions of oxytocin.",2021,"In intertemporal choice, patience was higher under oxytocin than under placebo, although this difference was evident only when restricting the analysis to the first experimental session (between-group comparison) due to carry-over effects.",['49 healthy volunteers (within-subject design'],"['Oxytocin', 'intranasal oxytocin', 'placebo', 'oxytocin', 'human social (inequity aversion) and non-social decision making (delay of gratification and cognitive flexibility']",['cognitive flexibility'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0233496', 'cui_str': 'Aversion'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0870398', 'cui_str': 'Deferred Gratification'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}]",49.0,0.0734,"In intertemporal choice, patience was higher under oxytocin than under placebo, although this difference was evident only when restricting the analysis to the first experimental session (between-group comparison) due to carry-over effects.","[{'ForeName': 'Georgia Eleni', 'Initials': 'GE', 'LastName': 'Kapetaniou', 'Affiliation': 'Department of Psychology, Ludwig Maximilian University Munich, Munich, Germany.'}, {'ForeName': 'Matthias A', 'Initials': 'MA', 'LastName': 'Reinhard', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilian University Munich, Munich, Germany.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Christian', 'Affiliation': 'Department of Psychology, Ludwig Maximilian University Munich, Munich, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Jobst', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilian University Munich, Munich, Germany.'}, {'ForeName': 'Philippe N', 'Initials': 'PN', 'LastName': 'Tobler', 'Affiliation': 'Zurich Center for Neuroeconomics, Department of Economics, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Padberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilian University Munich, Munich, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Soutschek', 'Affiliation': 'Department of Psychology, Ludwig Maximilian University Munich, Munich, Germany.'}]",eLife,['10.7554/eLife.61844'] 2036,33524515,"Effectiveness, safety, and cost-utility of a knee brace in medial knee osteoarthritis: the ERGONOMIE randomized controlled trial.","OBJECTIVE This pragmatic, multicenter, open-label, randomized controlled trial (RCT) aimed to compare the effectiveness, safety, and cost-utility of a custom-made knee brace versus usual care over 1 year in medial knee osteoarthritis (OA). DESIGN 120 patients with medial knee OA (VAS pain at rest >40/100), classified as Kellgren-Lawrence grade II-IV, were randomized into two groups: ODRA plus usual care (ODRA group) and usual care alone (UCA group). The primary effectiveness outcome was the change in VAS pain between M0 and M12. Secondary outcomes included changes over 1 year in KOOS (function) and OAKHQOL (quality of life) scores. Drug consumption, compliance, safety of the knee brace, and cost-utility over 1 year were also assessed. RESULTS The ODRA group was associated with a higher improvement in: VAS pain (adjusted mean difference of -11.8; 95% CI: -21.1 to -2.5); all KOOS subscales (pain: +8.8; 95% CI: 1.4-16.2); other symptoms (+10.4; 95% CI: 2.7-18); function in activities of daily living (+9.2; 95% CI: 1.1-17.2); function in sports and leisure (+12.3; 95% CI: 4.3-20.3); quality of life (+9.9; 95% CI: 0.9-15.9), OAKHQOL subscales (pain: +14.8; 95% CI: 5.0-24.6); and physical activities (+8.2; 95% CI: 0.6-15.8), and with a significant decrease in analgesics consumption at M12 compared with the UCA group. Despite localized side-effects, observance was good at M12 (median: 5.3 h/day). The ODRA group had a more than 85% chance of being cost-effective for a willingness-to-pay threshold of €45 000 per QALY. CONCLUSIONS The ERGONOMIE RCT demonstrated significant clinical benefits of an unloader custom-made knee brace in terms of improvements in pain, function, and some aspects of quality of life over 1 year in medial knee OA, as well as its potential cost-utility from a societal perspective.",2021,"The ODRA group was associated with a higher improvement in: VAS pain (adjusted mean difference of -11.8; 95% CI: -21.1 to -2.5); all KOOS subscales (pain: +8.8; 95% CI: 1.4-16.2); other symptoms (+10.4; 95% CI: 2.7-18); function in activities of daily living (+9.2; 95% CI: 1.1-17.2); function in sports and leisure (+12.3; 95% CI: 4.3-20.3); quality of life (+9.9; 95% CI: 0.9-15.9), OAKHQOL subscales (pain: +14.8; 95% CI: 5.0-24.6); and physical activities (+8.2; 95% CI: 0.6-15.8), and with a significant decrease in analgesics consumption at M12 compared with the UCA group.","['120 patients with medial knee OA (VAS pain at rest >40/100), classified as Kellgren-Lawrence grade II-IV', 'medial knee osteoarthritis (OA', 'medial knee osteoarthritis']","['UCA', 'custom-made knee brace versus usual care', 'ODRA plus usual care (ODRA group) and usual care alone (UCA group', 'ODRA', 'knee brace']","['Drug consumption, compliance, safety of the knee brace, and cost-utility', 'KOOS subscales', 'Effectiveness, safety, and cost-utility', 'changes over 1 year in KOOS (function) and OAKHQOL (quality of life) scores', 'VAS pain', 'physical activities', 'change in VAS pain between M0 and M12', 'quality of life', 'analgesics consumption', 'effectiveness, safety, and cost-utility', 'function in activities of daily living']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C1017304', 'cui_str': 'Uca'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",120.0,0.186727,"The ODRA group was associated with a higher improvement in: VAS pain (adjusted mean difference of -11.8; 95% CI: -21.1 to -2.5); all KOOS subscales (pain: +8.8; 95% CI: 1.4-16.2); other symptoms (+10.4; 95% CI: 2.7-18); function in activities of daily living (+9.2; 95% CI: 1.1-17.2); function in sports and leisure (+12.3; 95% CI: 4.3-20.3); quality of life (+9.9; 95% CI: 0.9-15.9), OAKHQOL subscales (pain: +14.8; 95% CI: 5.0-24.6); and physical activities (+8.2; 95% CI: 0.6-15.8), and with a significant decrease in analgesics consumption at M12 compared with the UCA group.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gueugnon', 'Affiliation': ""INSERM, CIC 1432, Centre D'Investigation Clinique, Module Plurithématique, Plateforme D'Investigation Technologiques, Dijon, France CHU Dijon-Bourgogne, Dijon, France. Electronic address: mathieu.gueugnon@chu-dijon.fr.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Fournel', 'Affiliation': ""INSERM, CIC 1432, Centre D'Investigation Clinique, Module EC, CHU Dijon-Bourgogne, Dijon, France. Electronic address: isabelle.fournel@chu-dijon.fr.""}, {'ForeName': 'A-L', 'Initials': 'AL', 'LastName': 'Soilly', 'Affiliation': 'Department of Clinical Research, Clinical Research Unit-Methodological Support Network CHU Dijon-Bourgogne, F-21000, Dijon, France. Electronic address: anne-laure.soilly@chu-dijon.fr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Diaz', 'Affiliation': 'Department of Rheumatology, CHU Dijon Bourgogne, F-21000 Dijon, France. Electronic address: harmonie.diaz@chu-dijon.fr.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Baulot', 'Affiliation': 'Department of Orthopedic Surgery, CHU Dijon Bourgogne, F-21000 Dijon, France; INSERM UMR 1093-CAPS, Bourgogne Franche-Comté University, UFR des Sciences et Du Sport. Electronic address: emmanuel.baulot@chu-dijon.fr.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bussière', 'Affiliation': 'Department of Orthopedic Surgery, Centre Orthopédique Medico-chirugical, Dracy-Le-Fort, France. Electronic address: christophe.bussiere@dracy.fr.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Casillas', 'Affiliation': ""INSERM, CIC 1432, Centre D'Investigation Clinique, Module Plurithématique, Plateforme D'Investigation Technologiques, Dijon, France CHU Dijon-Bourgogne, Dijon, France; INSERM UMR 1093-CAPS, Bourgogne Franche-Comté University, UFR des Sciences et Du Sport; Department of Physical Medicine and Rehabilitation, CHU Dijon Bourgogne, F-2100 Dijon, France. Electronic address: jean-marie.casillas@chu-dijon.fr.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cherasse', 'Affiliation': 'Department of Rheumatology, Hospital Center Mâcon, Mâcon, France. Electronic address: AnCHERASSE@ch-macon.fr.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Conrozier', 'Affiliation': 'Department of Rheumatology, Hospital Nord Franche-Comté, Belfort, France. Electronic address: tconrozier@chbm.fr.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Loeuille', 'Affiliation': 'Department of Rheumatology, CHU Nancy, F-54500 Vandoeuvre-lès-Nancy, France INSERM, CIC-EC CIE6, Nancy, France University Hospital of Nancy, Epidemiology and Clinical Evaluation, F-54500 Vandoeuvre-lès-Nancy, France. Electronic address: d.loeuille@chu-nancy.fr.'}, {'ForeName': 'J-F', 'Initials': 'JF', 'LastName': 'Maillefert', 'Affiliation': 'Department of Rheumatology, CHU Dijon Bourgogne, F-21000 Dijon, France; INSERM UMR 1093-CAPS, Bourgogne Franche-Comté University, UFR des Sciences et Du Sport. Electronic address: jean-francis.maillefert@chu-dijon.fr.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Mazalovic', 'Affiliation': ""INSERM, CIC 1432, Centre D'Investigation Clinique, Module EC, CHU Dijon-Bourgogne, Dijon, France; Department of General Medicine, Bourgogne Franche-Comté University, UFR des Sciences de Santé, Dijon, France. Electronic address: katia.mazalovic@u-bourgogne.fr.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Timsit', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Clinique de Provence Bourbonne, F-13400 Aubagne, France. Electronic address: m.timsit@ramsaygds.fr.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Wendling', 'Affiliation': 'Department of Rheumatology, CHU Besançon EA4266 Bourgogne Franche-Comté University, F-25030 Besançon, France. Electronic address: dwendling@chu-besancon.fr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ramon', 'Affiliation': 'Department of Rheumatology, CHU Dijon Bourgogne, F-21000 Dijon, France. Electronic address: andre.ramon@chu-dijon.fr.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Binquet', 'Affiliation': ""INSERM, CIC 1432, Centre D'Investigation Clinique, Module EC, CHU Dijon-Bourgogne, Dijon, France. Electronic address: christine.binquet@chu-dijon.fr.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Morisset', 'Affiliation': ""INSERM, CIC 1432, Centre D'Investigation Clinique, Module Plurithématique, Plateforme D'Investigation Technologiques, Dijon, France CHU Dijon-Bourgogne, Dijon, France. Electronic address: claire.morisset@chu-dijon.fr.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ornetti', 'Affiliation': ""INSERM, CIC 1432, Centre D'Investigation Clinique, Module Plurithématique, Plateforme D'Investigation Technologiques, Dijon, France CHU Dijon-Bourgogne, Dijon, France; Department of Rheumatology, CHU Dijon Bourgogne, F-21000 Dijon, France; INSERM UMR 1093-CAPS, Bourgogne Franche-Comté University, UFR des Sciences et Du Sport. Electronic address: paul.ornetti@chu-dijon.fr.""}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.11.009'] 2037,33508442,Potential impacts of Acu-TENS in the treatment of adolescents with moderate to severe bronchial asthma: A randomized clinical study.,"OBJECTIVE The purpose of this study was to evaluate the efficacy of transcutaneous electrical nerve stimulation over the acupuncture points (Acu-TENS) on total serum immunoglobulin E (IgE total ), pulmonary function, and quality of life in adolescents with asthma. METHODS In a double-blind randomized clinical trial, 32 adolescents (age; 12-16 years) with asthma participated and were assigned randomly to receive either the breathing retraining program (control group) or the breathing retraining program plus Acu-TENS application (Acu-TENS group). Acu-TENS was applied for 40 min' day-after-day session for two successive months, with no side-effects reported. Serum IgE total , pulmonary function [forced vital capacity (FVC), forced expiratory volume at one second (FEV 1 ), and FEV 1 /FVC], and quality of life were evaluated pre- and post-treatment. RESULTS Serum IgE total (P = 0.028, η p 2 = 0.15), Pulmonary function [FVC (P = 0.043, η p 2 = 0.13), FEV 1 (P = .046, η p 2 = 0.12)], and quality of life (P < .001, η p 2 = 0.17) increased significantly in the Acu-TENS group when compared to the control group. CONCLUSION This study demonstrates that the Acu-TENS is an impending asthma treatment that may be used to reinforce the immune system response, ameliorate lung function, and increase the quality of life in adolescents with asthma.",2021,"total (P = 0.028, η p 2  = 0.15), Pulmonary function [FVC (P =  0.043, η p 2  = 0.13), FEV 1 (P =  .046, η p 2  = 0.12)], and quality of life (P <  .001, η p 2  = 0.17) increased significantly in the Acu-TENS group when compared to the control group. ","['adolescents with moderate to severe bronchial asthma', '32 adolescents (age; 12-16 years) with asthma participated', 'adolescents with asthma']","['Acu-TENS', 'breathing retraining program (control group) or the breathing retraining program plus Acu-TENS application (Acu-TENS group', 'transcutaneous electrical nerve stimulation over the acupuncture points (Acu-TENS']","['Serum IgE', 'Pulmonary function [FVC', 'total serum immunoglobulin E (IgE total ), pulmonary function, and quality of life', 'Serum IgE total , pulmonary function [forced vital capacity (FVC), forced expiratory volume at one second (FEV 1 ), and FEV 1 /FVC], and quality of life', 'quality of life']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0856520', 'cui_str': 'Serum immunoglobulin E'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0042834', 'cui_str': 'Vital capacity'}]",32.0,0.0221138,"total (P = 0.028, η p 2  = 0.15), Pulmonary function [FVC (P =  0.043, η p 2  = 0.13), FEV 1 (P =  .046, η p 2  = 0.12)], and quality of life (P <  .001, η p 2  = 0.17) increased significantly in the Acu-TENS group when compared to the control group. ","[{'ForeName': 'Ragab K', 'Initials': 'RK', 'LastName': 'Elnaggar', 'Affiliation': 'Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt; Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia. Electronic address: rke_pt2001@yahoo.com.'}, {'ForeName': 'Samah A', 'Initials': 'SA', 'LastName': 'Moawd', 'Affiliation': 'Department of Physical Therapy for Cardiovascular/Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt; Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}, {'ForeName': 'Shaimaa E', 'Initials': 'SE', 'LastName': 'Ali', 'Affiliation': 'Department of Basic Sciences, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Abeer M', 'Initials': 'AM', 'LastName': 'Yousef', 'Affiliation': 'Department of Basic Sciences, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Alshimaa R', 'Initials': 'AR', 'LastName': 'Azab', 'Affiliation': 'Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt; Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2021.102673'] 2038,33821899,Effect of Celecoxib vs Placebo Added to Standard Adjuvant Therapy on Disease-Free Survival Among Patients With Stage III Colon Cancer: The CALGB/SWOG 80702 (Alliance) Randomized Clinical Trial.,"Importance Aspirin and cyclooxygenase 2 (COX-2) inhibitors have been associated with a reduced risk of colorectal polyps and cancer in observational and randomized studies. The effect of celecoxib, a COX-2 inhibitor, as treatment for nonmetastatic colon cancer is unknown. Objective To determine if the addition of celecoxib to adjuvant chemotherapy with fluorouracil, leucovorin, and oxaliplatin (FOLFOX) improves disease-free survival in patients with stage III colon cancer. Design, Setting, and Participants Cancer and Leukemia Group B (Alliance)/Southwest Oncology Group 80702 was a 2 × 2 factorial design, phase 3 trial conducted at 654 community and academic centers throughout the United States and Canada. A total of 2526 patients with stage III colon cancer were enrolled between June 2010 and November 2015 and were followed up through August 10, 2020. Interventions Patients were randomized to receive adjuvant FOLFOX (every 2 weeks) for 3 vs 6 months with or without 3 years of celecoxib (400 mg orally daily; n = 1263) vs placebo (n = 1261). This report focuses on the results of the celecoxib randomization. Main Outcomes and Measures The primary end point was disease-free survival, measured from the time of randomization until documented recurrence or death from any cause. Secondary end points included overall survival, adverse events, and cardiovascular-specific events. Results Of the 2526 patients who were randomized (mean [SD] age, 61.0 years [11 years]; 1134 women [44.9%]), 2524 were included in the primary analysis. Adherence with protocol treatment, defined as receiving celecoxib or placebo for more than 2.75 years or continuing treatment until recurrence, death, or unacceptable adverse events, was 70.8% for patients treated with celecoxib and 69.9% for patients treated with placebo. A total of 337 patients randomized to celecoxib and 363 to placebo experienced disease recurrence or died, and with 6 years' median follow-up, the 3-year disease-free survival was 76.3% for celecoxib-treated patients vs 73.4% for placebo-treated patients (hazard ratio [HR] for disease recurrence or death, 0.89; 95% CI, 0.76-1.03; P = .12). The effect of celecoxib treatment on disease-free survival did not vary significantly according to assigned duration of adjuvant chemotherapy (P for interaction = .61). Five-year overall survival was 84.3% for celecoxib vs 81.6% for placebo (HR for death, 0.86; 95% CI, 0.72-1.04; P = .13). Hypertension (any grade) occurred while treated with FOLFOX in 14.6% of patients in the celecoxib group vs 10.9% of patients in the placebo group, and a grade 2 or higher increase in creatinine levels occurred after completion of FOLFOX in 1.7% vs 0.5% of patients, respectively. Conclusions and Relevance Among patients with stage III colon cancer, the addition of celecoxib for 3 years, compared with placebo, to standard adjuvant chemotherapy did not significantly improve disease-free survival. Trial Registration ClinicalTrials.gov Identifier: NCT01150045.",2021,The effect of celecoxib treatment on disease-free survival did not vary significantly according to assigned duration of adjuvant chemotherapy (P for interaction = .61).,"['Group 80702 was a 2\u2009×\u20092 factorial design, phase 3 trial conducted at 654 community and academic centers throughout the United States and Canada', '1134 women [44.9%]), 2524 were included in the primary analysis', '2526 patients with stage III colon cancer were enrolled between June 2010 and November 2015 and were followed up through August 10, 2020', 'patients with stage III colon cancer', 'nonmetastatic colon cancer', '2526 patients who were randomized (mean [SD] age, 61.0 years [11 years', 'Participants\n\n\nCancer and Leukemia Group B ', '337 patients randomized to', 'Patients With Stage III Colon Cancer']","['FOLFOX', 'adjuvant FOLFOX', 'fluorouracil, leucovorin, and oxaliplatin (FOLFOX', 'placebo', 'Aspirin and cyclooxygenase 2 (COX-2) inhibitors', 'Alliance)/Southwest Oncology', 'celecoxib', 'Celecoxib vs Placebo', 'celecoxib or placebo']","['Disease-Free Survival', 'Hypertension', 'overall survival, adverse events, and cardiovascular-specific events', 'creatinine levels', 'disease-free survival', 'time of randomization until documented recurrence or death', 'recurrence, death, or unacceptable adverse events', 'disease recurrence or died', '3-year disease-free survival', 'overall survival']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278480', 'cui_str': 'Carcinoma of colon, stage III'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0387583', 'cui_str': 'Cyclooxygenase 2'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0201975', 'cui_str': 'Creatinine measurement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C0439234', 'cui_str': 'year'}]",2526.0,0.780474,The effect of celecoxib treatment on disease-free survival did not vary significantly according to assigned duration of adjuvant chemotherapy (P for interaction = .61).,"[{'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Meyerhardt', 'Affiliation': 'Department of Medical Oncology, Dana-Farber/Partners CancerCare, Boston, Massachusetts.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': 'Alliance Statistics and Data Management Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Fuchs', 'Affiliation': 'Yale Cancer Center, Yale School of Medicine, Smilow Cancer Hospital, New Haven, Connecticut.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Meyer', 'Affiliation': 'Alliance Statistics and Data Management Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Niedzwiecki', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Zemla', 'Affiliation': 'Alliance Statistics and Data Management Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Kumthekar', 'Affiliation': 'Feinberg School of Medicine, Northwestern Medicine, Chicago, Illinois.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Guthrie', 'Affiliation': 'SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Couture', 'Affiliation': 'Hôtel-Dieu de Québec, Quebec, Canada.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Kuebler', 'Affiliation': 'Columbus NCI Community Oncology Research Program, Columbus, Ohio.'}, {'ForeName': 'Johanna C', 'Initials': 'JC', 'LastName': 'Bendell', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology, Nashville.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': 'Illinois CancerCare PC, Peoria, Illinois.'}, {'ForeName': 'Dequincy', 'Initials': 'D', 'LastName': 'Lewis', 'Affiliation': 'Cone Health Medical Group, Asheboro, North Carolina.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Tan', 'Affiliation': 'Siteman Cancer Center, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Bertagnolli', 'Affiliation': ""Office of the Alliance Group Chair, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Grothey', 'Affiliation': 'West Cancer Center & Research Institute, Germantown, Tennessee.'}, {'ForeName': 'Howard S', 'Initials': 'HS', 'LastName': 'Hochster', 'Affiliation': 'Rutgers Cancer Institute, New Brunswick, New Jersey.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Goldberg', 'Affiliation': 'West Virginia University Cancer Institute, Morgantown.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Venook', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Blanke', 'Affiliation': ""SWOG Cancer Research Network Group Chair's Office, Oregon Health and Science University Knight Cancer Institute.""}, {'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': ""O'Reilly"", 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Weill Cornell Medical Center, New York, New York.'}, {'ForeName': 'Anthony F', 'Initials': 'AF', 'LastName': 'Shields', 'Affiliation': 'Department of Oncology, Karmanos Cancer Institute, Wayne State University, Detroit, Michigan.'}]",JAMA,['10.1001/jama.2021.2454'] 2039,33821898,Effect of Low-Intensity vs High-Intensity Home-Based Walking Exercise on Walk Distance in Patients With Peripheral Artery Disease: The LITE Randomized Clinical Trial.,"Importance Supervised high-intensity walking exercise that induces ischemic leg symptoms is the first-line therapy for people with lower-extremity peripheral artery disease (PAD), but adherence is poor. Objective To determine whether low-intensity home-based walking exercise at a comfortable pace significantly improves walking ability in people with PAD vs high-intensity home-based walking exercise that induces ischemic leg symptoms and vs a nonexercise control. Design, Setting, and Participants Multicenter randomized clinical trial conducted at 4 US centers and including 305 participants. Enrollment occurred between September 25, 2015, and December 11, 2019; final follow-up was October 7, 2020. Interventions Participants with PAD were randomized to low-intensity walking exercise (n = 116), high-intensity walking exercise (n = 124), or nonexercise control (n = 65) for 12 months. Both exercise groups were asked to walk for exercise in an unsupervised setting 5 times per week for up to 50 minutes per session wearing an accelerometer to document exercise intensity and time. The low-intensity group walked at a pace without ischemic leg symptoms. The high-intensity group walked at a pace eliciting moderate to severe ischemic leg symptoms. Accelerometer data were viewable to a coach who telephoned participants weekly for 12 months and helped them adhere to their prescribed exercise. The nonexercise control group received weekly educational telephone calls for 12 months. Main Outcomes and Measures The primary outcome was mean change in 6-minute walk distance at 12 months (minimum clinically important difference, 8-20 m). Results Among 305 randomized patients (mean age, 69.3 [SD, 9.5] years, 146 [47.9%] women, 181 [59.3%] Black patients), 250 (82%) completed 12-month follow-up. The 6-minute walk distance changed from 332.1 m at baseline to 327.5 m at 12-month follow-up in the low-intensity exercise group (within-group mean change, -6.4 m [95% CI, -21.5 to 8.8 m]; P = .34) and from 338.1 m to 371.2 m in the high-intensity exercise group (within-group mean change, 34.5 m [95% CI, 20.1 to 48.9 m]; P < .001) and the mean change for the between-group comparison was -40.9 m (97.5% CI, -61.7 to -20.0 m; P < .001). The 6-minute walk distance changed from 328.1 m at baseline to 317.5 m at 12-month follow-up in the nonexercise control group (within-group mean change, -15.1 m [95% CI, -35.8 to 5.7 m]; P = .10), which was not significantly different from the change in the low-intensity exercise group (between-group mean change, 8.7 m [97.5% CI, -17.0 to 34.4 m]; P = .44). Of 184 serious adverse events, the event rate per participant was 0.64 in the low-intensity group, 0.65 in the high-intensity group, and 0.46 in the nonexercise control group. One serious adverse event in each exercise group was related to study participation. Conclusions and Relevance Among patients with PAD, low-intensity home-based exercise was significantly less effective than high-intensity home-based exercise and was not significantly different from the nonexercise control for improving 6-minute walk distance. These results do not support the use of low-intensity home-based walking exercise for improving objectively measured walking performance in patients with PAD. Trial Registration ClinicalTrials.gov Identifier: NCT02538900.",2021,"Of 184 serious adverse events, the event rate per participant was 0.64 in the low-intensity group, 0.65 in the high-intensity group, and 0.46 in the nonexercise control group.","['patients with PAD', '305 randomized patients (mean age, 69.3 [SD, 9.5] years, 146 [47.9', 'people with PAD vs high-intensity home-based', 'women, 181 [59.3%] Black patients), 250 (82%) completed 12-month follow-up', 'Interventions\n\n\nParticipants with PAD', '4 US centers and including 305 participants', 'Patients With Peripheral Artery Disease', 'people with lower-extremity peripheral artery disease (PAD']","['low-intensity walking exercise (n\u2009=\u2009116), high-intensity walking exercise (n\u2009=\u2009124), or nonexercise control', 'educational telephone calls', 'walking exercise', 'Importance\n\n\nSupervised high-intensity walking exercise', 'low-intensity home-based walking exercise', 'Low-Intensity vs High-Intensity Home-Based Walking Exercise']","['mean change in 6-minute walk distance', 'ischemic leg symptoms', '6-minute walk distance', 'Walk Distance', 'walking ability', 'severe ischemic leg symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]","[{'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0340565', 'cui_str': 'Lower limb ischemia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",305.0,0.0295625,"Of 184 serious adverse events, the event rate per participant was 0.64 in the low-intensity group, 0.65 in the high-intensity group, and 0.46 in the nonexercise control group.","[{'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'McDermott', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Spring', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Tian', 'Affiliation': 'Department of Health Research and Policy, Stanford University, Stanford, California.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Treat-Jacobson', 'Affiliation': 'School of Nursing, University of Minnesota, Minneapolis.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Ferrucci', 'Affiliation': 'Division of Intramural Research, National Institute on Aging, Bethesda, Maryland.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Lloyd-Jones', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Lihui', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Polonsky', 'Affiliation': 'Department of Medicine, Medical School, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Melina R', 'Initials': 'MR', 'LastName': 'Kibbe', 'Affiliation': 'Department of Surgery, School of Medicine, University of North Carolina, Chapel Hill.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Bazzano', 'Affiliation': 'Tulane University, New Orleans, Louisiana.'}, {'ForeName': 'Jack M', 'Initials': 'JM', 'LastName': 'Guralnik', 'Affiliation': 'Department of Epidemiology, University of Maryland, College Park.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Forman', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Al', 'Initials': 'A', 'LastName': 'Rego', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Dongxue', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Domanchuk', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Christiaan', 'Initials': 'C', 'LastName': 'Leeuwenburgh', 'Affiliation': 'University of Florida, Gainesville.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Sufit', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Smith', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Manini', 'Affiliation': 'University of Florida, Gainesville.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Criqui', 'Affiliation': 'University of California, San Diego.'}, {'ForeName': 'W Jack', 'Initials': 'WJ', 'LastName': 'Rejeski', 'Affiliation': 'Wake Forest University, Winston-Salem, North Carolina.'}]",JAMA,['10.1001/jama.2021.2536'] 2040,33516458,Amygdala and Insula Connectivity Changes Following Psychotherapy for Posttraumatic Stress Disorder: A Randomized Clinical Trial.,"BACKGROUND Exposure-based psychotherapy is a first-line treatment for posttraumatic stress disorder (PTSD), but its mechanisms are poorly understood. Functional brain connectivity is a promising metric for identifying treatment mechanisms and biosignatures of therapeutic response. To this end, we assessed amygdala and insula treatment-related connectivity changes and their relationship to PTSD symptom improvements. METHODS Individuals with a primary PTSD diagnosis (N = 66) participated in a randomized clinical trial of prolonged exposure therapy (n = 36) versus treatment waiting list (n = 30). Task-free functional magnetic resonance imaging was completed prior to randomization and 1 month following cessation of treatment/waiting list. Whole-brain blood oxygenation level-dependent responses were acquired. Intrinsic connectivity was assessed by subregion in the amygdala and insula, limbic structures key to the disorder pathophysiology. Dynamic causal modeling assessed evidence for effective connectivity changes in select nodes informed by intrinsic connectivity findings. RESULTS The amygdala and insula displayed widespread patterns of primarily subregion-uniform intrinsic connectivity change, including increased connectivity between the amygdala and insula; increased connectivity of both regions with the ventral prefrontal cortex and frontopolar and sensory cortices; and decreased connectivity of both regions with the left frontoparietal nodes of the executive control network. Larger decreases in amygdala-frontal connectivity and insula-parietal connectivity were associated with larger PTSD symptom reductions. Dynamic causal modeling evidence suggested that treatment decreased left frontal inhibition of the left amygdala, and larger decreases were associated with larger symptom reductions. CONCLUSIONS PTSD psychotherapy adaptively attenuates functional interactions between frontoparietal and limbic brain circuitry at rest, which may reflect a potential mechanism or biosignature of recovery.",2021,Larger decreases in amygdala-frontal connectivity and insula-parietal connectivity were associated with larger PTSD symptom reductions.,"['Posttraumatic Stress Disorder', 'posttraumatic stress disorder (PTSD', 'Individuals with a primary PTSD diagnosis (N\xa0= 66']","['Exposure-based psychotherapy', 'prolonged exposure therapy (n\xa0= 36) versus treatment waiting list', 'Psychotherapy', 'PTSD psychotherapy']","['left frontal inhibition', 'Intrinsic connectivity', 'amygdala-frontal connectivity and insula-parietal connectivity', 'connectivity of both regions with the ventral prefrontal cortex and frontopolar and sensory cortices']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0004302', 'cui_str': 'Auditory area of cortex'}]",66.0,0.0356912,Larger decreases in amygdala-frontal connectivity and insula-parietal connectivity were associated with larger PTSD symptom reductions.,"[{'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Fonzo', 'Affiliation': 'Department of Psychiatry, University of Texas at Austin Dell Medical School, Austin, Texas.'}, {'ForeName': 'Madeleine S', 'Initials': 'MS', 'LastName': 'Goodkind', 'Affiliation': 'New Mexico Veterans Affairs Healthcare System, Albuquerque, New Mexico.'}, {'ForeName': 'Desmond J', 'Initials': 'DJ', 'LastName': 'Oathes', 'Affiliation': 'Center for Neuromodulation in Depression and Stress, Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Yevgeniya V', 'Initials': 'YV', 'LastName': 'Zaiko', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California; Wu Tsai Neurosciences Institute, Stanford University, Stanford, California; Veterans Affairs Palo Alto Healthcare System and Sierra Pacific Mental Illness, Research, Education, and Clinical Center, Palo Alto, California.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Harvey', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California; Wu Tsai Neurosciences Institute, Stanford University, Stanford, California; Veterans Affairs Palo Alto Healthcare System and Sierra Pacific Mental Illness, Research, Education, and Clinical Center, Palo Alto, California.'}, {'ForeName': 'Kathy K', 'Initials': 'KK', 'LastName': 'Peng', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California; Wu Tsai Neurosciences Institute, Stanford University, Stanford, California; Veterans Affairs Palo Alto Healthcare System and Sierra Pacific Mental Illness, Research, Education, and Clinical Center, Palo Alto, California.'}, {'ForeName': 'M Elizabeth', 'Initials': 'ME', 'LastName': 'Weiss', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California; Wu Tsai Neurosciences Institute, Stanford University, Stanford, California; Veterans Affairs Palo Alto Healthcare System and Sierra Pacific Mental Illness, Research, Education, and Clinical Center, Palo Alto, California.'}, {'ForeName': 'Allison L', 'Initials': 'AL', 'LastName': 'Thompson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Sanno E', 'Initials': 'SE', 'LastName': 'Zack', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Lindley', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California; Veterans Affairs Palo Alto Healthcare System and Sierra Pacific Mental Illness, Research, Education, and Clinical Center, Palo Alto, California.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Arnow', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Booil', 'Initials': 'B', 'LastName': 'Jo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Barbara O', 'Initials': 'BO', 'LastName': 'Rothbaum', 'Affiliation': 'Trauma and Anxiety Recovery Program, Department of Psychiatry, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Etkin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California; Wu Tsai Neurosciences Institute, Stanford University, Stanford, California; Alto Neuroscience, Los Altos, California. Electronic address: amitetkin@altoneuroscience.com.'}]",Biological psychiatry,['10.1016/j.biopsych.2020.11.021'] 2041,33522019,Outcomes of combined use of topical and intravenous tranexamic acid on surgical field quality during functional endoscopic sinus surgery: Randomized controlled trial.,"BACKGROUND Intraoperative bleeding during functional endoscopic sinus surgery (FESS) poses a challenge to both surgeon and anesthetist. The primary aim of this study was to evaluate the effectiveness of local, intravenous and combined use of tranexamic acid (TA) in improving the surgical field quality during FESS. METHODS We conducted a randomized controlled double-blinded prospective trial on 120 patients scheduled for elective FESS. After induction of general anesthesia, patients were randomly and evenly assigned to one of four groups; IV TA, local TA, both IV and local TA, and placebo. Surgical field was assessed using five-point Boezaart scale. Total fentanyl and esmolol consumption, operative time, recovery time, and postoperative complications were recorded. RESULTS Surgical field quality score was the best in IV and local TA group compared to others (p < 0.001). Mean operative time was found significantly shorter in IV and local TA group than placebo one. Total fentanyl consumption was significantly lower in IV and local TA group comparing to others (p = 0.025). Mean recovery time was significantly shorter for IV and local TA group compared to others. Total fentanyl consumption was significantly lower in IV and local TA group comparing to others. No significant differences were found of mean arterial pressure and heart rate decline in four groups. None of the patients in four groups required esmolol administration. No statistically significant differences were found in change of hemoglobin, hematocrit, prothrombin time, and partial thromboplastin time over time in all groups. CONCLUSION The combined use of topical and intravenous TA provided the best surgical field in FESS, less fentanyl consumption, and less recovery time without causing significant side effects.",2021,Total fentanyl consumption was significantly lower in IV and local TA group comparing to others (p = 0.025).,"['functional endoscopic sinus surgery', '120 patients scheduled for elective FESS']","['tranexamic acid (TA', 'esmolol', 'IV TA, local TA, both IV and local TA, and placebo', 'topical and intravenous tranexamic acid', 'functional endoscopic sinus surgery (FESS', 'topical and intravenous TA']","['change of hemoglobin, hematocrit, prothrombin time, and partial thromboplastin time over time', 'Mean operative time', 'Total fentanyl consumption', 'mean arterial pressure and heart rate decline', 'Mean recovery time', 'surgical field quality', 'Total fentanyl and esmolol consumption, operative time, recovery time, and postoperative complications', 'Surgical field quality score']","[{'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0116569', 'cui_str': 'esmolol'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0116569', 'cui_str': 'esmolol'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",120.0,0.0878037,Total fentanyl consumption was significantly lower in IV and local TA group comparing to others (p = 0.025).,"[{'ForeName': 'Hala Salah El-Din', 'Initials': 'HSE', 'LastName': 'El-Ozairy', 'Affiliation': 'Department of Anaesthesia, ICU and Pain Management, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Ossama Mustafa', 'Initials': 'OM', 'LastName': 'Mady', 'Affiliation': 'Department of Otorhinolaryngology, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Gehad Mohamed', 'Initials': 'GM', 'LastName': 'Tawfik', 'Affiliation': 'Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Ahmed Mohamed', 'Initials': 'AM', 'LastName': 'Elhennawy', 'Affiliation': 'Department of Anaesthesia, ICU and Pain Management, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Ahmed Abdelmoneim', 'Initials': 'AA', 'LastName': 'Teaima', 'Affiliation': 'Department of Otorhinolaryngology, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Ebied', 'Affiliation': 'Online Research Club (http://www.onlineresearchclub.org/), Nagasaki, Japan.'}, {'ForeName': 'Nguyen Tien', 'Initials': 'NT', 'LastName': 'Huy', 'Affiliation': 'Institute of Research and Development, Duy Tan University, Da Nang, Vietnam.'}]",Head & neck,['10.1002/hed.26610'] 2042,33524264,Deficits of Learning in Procedural Memory and Consolidation in Declarative Memory in Adults With Developmental Language Disorder.,"Purpose This study examined procedural and declarative learning and consolidation abilities in adults with developmental language disorder (DLD) relative to their typical language (TD) peers. Method A total of 100 young adults (age 18-24 years) with ( n = 21) and without ( n = 79) DLD participated across two sites. Performance measures on a recognition memory task and a serial reaction time task were used to assess declarative and procedural memory, respectively. Performance was measured shortly after learning (8 a.m.) and again after a 12-hr, overnight delay (8 a.m.). Results Linear mixed-effects modeling was used to examine the effects of time and group membership on task performance. For the serial reaction time task, there were significant effects of group (TD > DLD) and time (Day 1 > Day 2), but no interaction between them. For the recognition memory task, there was a significant interaction between group and time, driven by overnight gains in the TD group, combined with stable performance across days by those with DLD. Conclusions In procedural memory, adults with DLD demonstrate a learning deficit relative to adults without DLD, but appear to have comparable retention of learned information. In declarative memory, adults with DLD demonstrate a deficit in the overnight enhancement of memory retrieval, despite typical-like learning exhibited when tested shortly after encoding. Supplemental Material https://doi.org/10.23641/asha.13626485.",2021,"Performance measures on a recognition memory task and a serial reaction time task were used to assess declarative and procedural memory, respectively.","['100 young adults (age 18-24 years) with ( n = 21) and without ( n = 79) DLD participated across two sites', 'Adults With Developmental Language Disorder', 'adults with developmental language disorder (DLD) relative to their typical language (TD) peers']",['Supplemental Material https://doi.org/10.23641/asha.13626485'],"['recognition memory task and a serial reaction time task', 'Performance', 'task performance']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023014', 'cui_str': 'Developmental language disorder'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0023008', 'cui_str': 'Language'}]","[{'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",100.0,0.0416893,"Performance measures on a recognition memory task and a serial reaction time task were used to assess declarative and procedural memory, respectively.","[{'ForeName': 'F Sayako', 'Initials': 'FS', 'LastName': 'Earle', 'Affiliation': 'Department of Communication Sciences and Disorders, University of Delaware, Newark.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Ullman', 'Affiliation': 'Department of Neuroscience, Georgetown University, Washington, DC.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2020_JSLHR-20-00292'] 2043,33527359,Conservative vs radical bowel surgery for endometriosis: A systematic analysis of complications.,"BACKGROUND Endometriosis of the bowel can be associated with significant morbidity. Surgery to remove it carries risks. Options include conservative shaving or discoid resection and more radical segmental bowel resection. AIMS To determine if more conservative shaving or discoid bowel resection is associated with fewer risks than more radical segmental resection. MATERIAL AND METHODS This study is a systematic review. We considered eligible any cohort, observational or randomised controlled trial (RCT) study of at least ten women per arm comparing conservative vs radical bowel surgery for endometriosis. We divided complications into two groups, major and minor. One additional article was added due to its significance in answering our study question as well as the high quality of the study design as an RCT. RESULTS There were 3041 studies screened. Eleven studies were included (n = 1648). For major complications, the risk ratio for shaving and disc excision vs segmental resection is 0.31 (95% CI 0.21-0.46), while the risk difference is -0.25 (95% CI -0.41 to 0.10). For minor complications, the risk ratio is 0.63 (95% CI 0.36-1.09), while the risk difference is -0.03 (95% CI -0.12 to 0.05). CONCLUSIONS Conservative shaving or discoid excision surgery is associated with reduced complications. Previous studies demonstrated a trend toward this finding, but suffered from relatively low participant numbers, increasing the risk of type one statistical error. Our results allow surgeons to make informed choices about potential complications when deciding how to approach bowel endometriosis. The results also allow patients to have more information about the risks. However, outcomes in the studies analysed are heterogenous and are from low-quality evidence.",2021,"For minor complications, the risk ratio is 0.63 (95% CI 0.36-1.09), while the risk difference is -0.03 (95% CI -0.12 to 0.05). ","['endometriosis', 'Eleven studies were included (n\xa0=\xa01648']","['conservative shaving or discoid resection', 'conservative vs radical bowel surgery', 'Conservative vs radical bowel surgery']",['risk ratio for shaving and disc excision vs segmental resection'],"[{'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0518505', 'cui_str': 'Does shave'}, {'cui': 'C0439641', 'cui_str': 'Discoid'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0192573', 'cui_str': 'Operation on intestine'}]","[{'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0518505', 'cui_str': 'Does shave'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205122', 'cui_str': 'Segmental'}]",,0.139661,"For minor complications, the risk ratio is 0.63 (95% CI 0.36-1.09), while the risk difference is -0.03 (95% CI -0.12 to 0.05). ","[{'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Heinz-Partington', 'Affiliation': 'Acute Gynaecology, Early Pregnancy and Advanced Endosurgery Unit, Sydney Medical School Nepean, Nepean Hospital, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Costa', 'Affiliation': 'Reproductive Medicine, Ginecologia, Goiânia, Brazil.'}, {'ForeName': 'Wellington P', 'Initials': 'WP', 'LastName': 'Martins', 'Affiliation': 'Reproductive Medicine, FMRP-USP, Ribeirao Preto, Brazil.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Condous', 'Affiliation': 'Acute Gynaecology, Early Pregnancy and Advanced Endosurgery Unit, Sydney Medical School Nepean, Nepean Hospital, University of Sydney, Sydney, New South Wales, Australia.'}]",The Australian & New Zealand journal of obstetrics & gynaecology,['10.1111/ajo.13311'] 2044,33529810,"Safety and Effectiveness of Dapoxetine On Demand in Chinese Men With Premature Ejaculation: Results of a Multicenter, Prospective, Open-Label Phase IV Study.","INTRODUCTION Dapoxetine on demand has been approved for premature ejaculation (PE) management in China; however, studies on the efficacy and safety of this treatment in the Chinese population are scarce. AIM The aim of this study was to evaluate the safety and effectiveness of dapoxetine 30 mg and 60 mg on demand in Chinese men with PE. METHODS Phase IV real-world study on 1,252 patients with PE. If men reported no response to dapoxetine 30 mg after 4 weeks treatment, dapoxetine has been uptitrated at 60 mg for 4 weeks more. MAIN OUTCOME MEASURE Self-reported data were collected for demographics, general and sexual health characteristics, PE severity, and treatment safety and effectiveness, as measured by the PE profile questionnaire. RESULTS Adverse events (AEs), such as nausea, thirst, headache, and dizziness, similarly to previous literature, were detected. The treatment-emergent AEs rate was higher in the patients treated with 30 and 60 mg (n = 192) compared with those treated with the dapoxetine 30 mg only (n = 1060) (34.4% vs 15.8%, respectively). No new safety concerns were observed. The overall effectiveness rates were 88.2% in subjects using 30 mg of dapoxetine, whereas a rescue from the previous failure was in 55.7% in the patients who received 60 mg after the initial 30 mg. Overall, 83.2% responded to dapoxetine at dosages equal to or lower than 60 mg. CONCLUSION The results in this study demonstrated in a large Chinese population that on-demand dapoxetine is a safe and effective symptomatic treatment in patients with PE. J Peng, L Yang, L Liu, et al. Safety and Effectiveness of Dapoxetine On Demand in Chinese Men With Premature Ejaculation: Results of a Multicenter, Prospective, Open-Label Phase IV Study. Sex Med 2021;9:100296.",2021,"The treatment-emergent AEs rate was higher in the patients treated with 30 and 60 mg (n = 192) compared with those treated with the dapoxetine 30 mg only (n = 1060) (34.4% vs 15.8%, respectively).","['patients with PE', 'Chinese men with PE', '1,252 patients with PE', 'Chinese Men With Premature Ejaculation', 'premature ejaculation (PE) management in China']","['dapoxetine', 'Dapoxetine']","['safety and effectiveness', 'Adverse events (AEs), such as nausea, thirst, headache, and dizziness', 'overall effectiveness rates', 'treatment-emergent AEs rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0215087', 'cui_str': 'dapoxetine'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",1252.0,0.0218966,"The treatment-emergent AEs rate was higher in the patients treated with 30 and 60 mg (n = 192) compared with those treated with the dapoxetine 30 mg only (n = 1060) (34.4% vs 15.8%, respectively).","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Peng', 'Affiliation': 'Andrology Center, Department of Urology, Peking University First Hospital, Peking University, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""Department of Urology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, North Theater General Hospital, Shenyang, China.'}, {'ForeName': 'Renyuan', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': 'Department of Urology, Shanghai Jingan District Central Hospital, Shanghai, China.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, Tongji Hospital Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Ningchen', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Peking University Shougang Hospital, Beijing, China.'}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Urology, General Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Yongguang', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Urology, Beijing Anzhen Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Yuqiang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Urology, Second Hospital of Shandong University, Ji'nan, China.""}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Department of Urology, Union Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Beijing Chaoyang Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Guowei', 'Initials': 'G', 'LastName': 'Shi', 'Affiliation': ""Department of Urology, Shanghai Fifth People's Hospital of Fudan University, Shanghai, China.""}, {'ForeName': 'Suyog', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Medical Department, A Menarini Asia Pacific, Singapore.'}, {'ForeName': 'Emmanuele A', 'Initials': 'EA', 'LastName': 'Jannini', 'Affiliation': 'Chair of Endocrinology and Medical Sexology (ENDOSEX), Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.'}, {'ForeName': 'Zhichao', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Andrology Center, Department of Urology, Peking University First Hospital, Peking University, Beijing, China. Electronic address: zhangzhichao@bjmu.edu.cn.'}]",Sexual medicine,['10.1016/j.esxm.2020.100296'] 2045,33533901,Early Corticosteroid Cessation vs Long-term Corticosteroid Therapy in Kidney Transplant Recipients: Long-term Outcomes of a Randomized Clinical Trial.,"Importance The complications of corticosteroids make the inclusion of these drugs in immunosuppressive protocols for kidney transplant patients undesirable. However, cessation of corticosteroids is associated with a higher risk of short-term rejection, and the long-term outcomes of patients withdrawn from corticosteroids remain uncertain. Objective To compare long-term kidney transplant outcomes of patients randomized to continue or withdraw corticosteroids. Design, Setting, and Participants This prospective multicenter randomized double-blind placebo-controlled trial was conducted between November 1999 and December 2002 with linkage to a mandatory national registry with validated outcome ascertainment until June 8, 2018. The study included 28 kidney transplant centers in the United States, including 386 low- to moderate-immune risk adult recipients of a living or deceased donor kidney transplant without delayed graft function or short-term rejection in the first week after transplant. Analyses were intention to treat. Analysis began September 2018 and ended June 2019. Interventions Patients were randomized to receive tacrolimus and mycophenolate mofetil with or without corticosteroids 7 days after transplant. Main Outcomes and Measures Kidney allograft failure from any cause including death and allograft failure censored for patient death defined by the requirement for long-term dialysis or repeat transplant. Results Of 385 patients, 191 were assigned to withdraw from corticosteroids (mean [SD] age, 46.5 [12.1] years), and 194 patients were assigned to continued corticosteroids (mean [SD] age, 46.3 [12.6] years). The median (interquartile range) follow-up time was 15.8 (12.0-16.3) years after transplant. The adjusted hazard ratios of allograft failure from any cause including death was 0.83 (95% CI, 0.62-1.10; P = .19) and for allograft failure censored for patient death was 0.78 (95% CI, 0.52-1.19; P = .25) and did not differ between the patients assigned to withdraw from corticosteroids vs assigned to continued corticosteroids. Results were consistent in a per-protocol analysis among 223 patients who continued the trial-assigned treatment of corticosteroid withdrawal (n = 114) or corticosteroids (n = 109) through at least 5 years after transplant. The outcomes of trial participants in either treatment group did not differ from similarly treated contemporary registry patients who met trial eligibility criteria and were treated with the same immunosuppressive drugs. Conclusions and Relevance Long-term corticosteroids may not be necessary as part of a calcineurin-based multiple drug immunosuppressive regimen in low- to moderate-immune risk kidney transplant recipients.",2021,"The outcomes of trial participants in either treatment group did not differ from similarly treated contemporary registry patients who met trial eligibility criteria and were treated with the same immunosuppressive drugs. ","['kidney transplant patients undesirable', 'Kidney Transplant Recipients', 'trial participants in either treatment group did not differ from similarly treated contemporary registry patients who met trial eligibility criteria and were treated with the same immunosuppressive drugs', '28 kidney transplant centers in the United States, including 386 low- to moderate-immune risk adult recipients of a living or deceased donor kidney transplant without delayed graft function or short-term rejection in the first week after transplant', '385 patients, 191 were assigned to withdraw from corticosteroids (mean [SD] age, 46.5 [12.1] years), and 194 patients were assigned to continued corticosteroids (mean [SD] age, 46.3 [12.6] years', '223 patients who continued the trial-assigned treatment of corticosteroid withdrawal (n\u2009=\u2009114) or', 'low- to moderate-immune risk kidney transplant recipients', 'November 1999 and December 2002 with linkage to a mandatory national registry with validated outcome ascertainment until June 8, 2018']","['corticosteroids', 'tacrolimus and mycophenolate mofetil with or without corticosteroids', 'Corticosteroid Cessation vs Long-term Corticosteroid Therapy', 'placebo']","['allograft failure censored for patient death', 'Measures\n\n\nKidney allograft failure from any cause including death and allograft failure censored for patient death defined by the requirement for long-term dialysis or repeat transplant', 'death', 'adjusted hazard ratios of allograft failure']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0260788', 'cui_str': 'Donor of kidney for transplant'}, {'cui': 'C1566590', 'cui_str': 'Delayed graft function'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C4517751', 'cui_str': '385'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517545', 'cui_str': '12.6'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",28.0,0.191103,"The outcomes of trial participants in either treatment group did not differ from similarly treated contemporary registry patients who met trial eligibility criteria and were treated with the same immunosuppressive drugs. ","[{'ForeName': 'E Steve', 'Initials': 'ES', 'LastName': 'Woodle', 'Affiliation': 'College of Medicine, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Gill', 'Affiliation': 'Division of Nephrology, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Clark', 'Affiliation': 'Providence Health Care Research Institute, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Stewart', 'Affiliation': 'United Network for Organ Sharing, Richmond, Virginia.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Alloway', 'Affiliation': 'College of Medicine, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'First', 'Affiliation': 'Comprehensive Transplant Center, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}]",JAMA surgery,['10.1001/jamasurg.2020.6929'] 2046,33533873,Association of Effective Regurgitation Orifice Area to Left Ventricular End-Diastolic Volume Ratio With Transcatheter Mitral Valve Repair Outcomes: A Secondary Analysis of the COAPT Trial.,"Importance Transcatheter mitral valve repair (TMVr) plus maximally tolerated guideline-directed medical therapy (GDMT) reduced heart failure (HF) hospitalizations (HFHs) and all-cause mortality (ACM) in symptomatic patients with HF and secondary mitral regurgitation (SMR) compared with GDMT alone in the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (COAPT) trial but not in a similar trial, Multicenter Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation (MITRA-FR), possibly because the degree of SMR relative to the left ventricular end-diastolic volume index (LVEDVi) was substantially lower. Objective To explore contributions of the degree of SMR using the effective regurgitation orifice area (EROA), regurgitant volume (RV), and LVEDVi to the benefit of TMVr in the COAPT trial. Design, Setting, and Participants This post hoc secondary analysis of the COAPT randomized clinical trial performed December 27, 2012, to June 23, 2017, evaluated a subgroup of COAPT patients (group 1) with characteristics consistent with patients enrolled in MITRA-FR (n = 56) (HF with grade 3+ to 4+ SMR, left ventricular ejection fraction of 20%-50%, and New York Heart Association function class II-IV) compared with remaining (group 2) COAPT patients (n = 492) using the end point of ACM or HFH at 24 months, components of the primary end point, and quality of life (QOL) (per the Kansas City Cardiomyopathy Questionnaire overall summary score) and 6-minute walk distance (6MWD). The same end points were evaluated in 6 subgroups of COAPT by combinations of EROA and LVEDVi and of RV relative to LVEDVi. Interventions Interventions were TMVr plus GDMT vs GDMT alone. Results A total of 548 participants (mean [SD] age, 71.9 [11.2] years; 351 [64%] male) were included. In group 1, no significant difference was found in the composite rate of ACM or HFH between TMVr plus GDMT vs GDMT alone at 24 months (27.8% vs 33.1%, P = .83) compared with a significant difference at 24 months (31.5% vs 50.2%, P < .001) in group 2. However, patients randomized to receive TMVr vs those treated with GDMT alone had significantly greater improvement in QOL at 12 months (mean [SD] Kansas City Cardiomyopathy Questionnaire summary scores: group 1: 18.36 [5.38] vs 0.43 [4.00] points; P = .01; group 2: 16.54 [1.57] vs 5.78 [1.82] points; P < .001). Group 1 TMVr-randomized patients vs those treated with GDMT alone also had significantly greater improvement in 6MWD at 12 months (mean [SD] paired improvement: 39.0 [28.6] vs -48.0 [18.6] m; P = .02). Group 2 TMVr-randomized patients vs those treated with GDMT alone tended to have greater improvement in 6MWD at 12 months, but the difference did not reach statistical significance (mean [SD] paired improvement: 35.0 [7.7] vs 16.0 [9.1] m; P = .11). Conclusions and Relevance A small subgroup of COAPT-resembling patients enrolled in MITRA-FR did not achieve improvement in ACM or HFH at 24 months but had a significant benefit on patient-centered outcomes (eg, QOL and 6MWD). Further subgroup analyses with 24-month follow-up suggest that the benefit of TMVr is not fully supported by the proportionate-disproportionate hypothesis. Trial Registration ClinicalTrials.gov Identifier: NCT01626079.",2021,Group 1 TMVr-randomized patients vs those treated with GDMT alone also had significantly greater improvement in 6MWD at 12 months,"['December 27, 2012, to June 23, 2017, evaluated a subgroup of COAPT patients (group 1) with characteristics consistent with patients enrolled in MITRA-FR (n\u2009=\u200956) (HF with grade 3+ to 4+ SMR, left ventricular ejection fraction of 20%-50%, and New York Heart Association function class II-IV) compared with remaining (group 2) COAPT patients (n\u2009=\u2009492) using the end point of', 'symptomatic patients with HF and secondary mitral regurgitation (SMR', 'Heart Failure Patients With Functional Mitral Regurgitation (COAPT', '548 participants (mean [SD] age, 71.9 [11.2] years; 351 [64%] male) were included']","['TMVr plus GDMT vs GDMT alone', 'GDMT alone', 'Percutaneous Mitral Valve Repair MitraClip Device', 'Transcatheter Mitral Valve Repair Outcomes', 'Transcatheter mitral valve repair (TMVr) plus maximally tolerated guideline-directed medical therapy (GDMT', 'ACM or HFH', 'GDMT', 'MitraClip Percutaneous Therapy', 'TMVr']","['6MWD', 'composite rate of ACM or HFH', 'QOL', 'quality of life (QOL) (per the Kansas City Cardiomyopathy Questionnaire overall summary score) and 6-minute walk distance (6MWD', 'EROA and LVEDVi and of RV relative to LVEDVi', 'ACM or HFH', 'heart failure (HF) hospitalizations (HFHs) and all-cause mortality (ACM', 'effective regurgitation orifice area (EROA), regurgitant volume (RV), and LVEDVi to the benefit of TMVr']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C3179739', 'cui_str': 'lanthanum citrate'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0340369', 'cui_str': 'Functional mitral regurgitation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517531', 'cui_str': '11.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C2921039', 'cui_str': 'Transcatheter mitral valve repair'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0396849', 'cui_str': 'Mitral valvuloplasty'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0232605', 'cui_str': 'Regurgitates after swallowing'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042509', 'cui_str': 'Ventricular End-Diastolic Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0455833', 'cui_str': 'Left ventricular end-diastolic cavity size'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C2921039', 'cui_str': 'Transcatheter mitral valve repair'}]",548.0,0.114519,Group 1 TMVr-randomized patients vs those treated with GDMT alone also had significantly greater improvement in 6MWD at 12 months,"[{'ForeName': 'JoAnn', 'Initials': 'J', 'LastName': 'Lindenfeld', 'Affiliation': 'Advanced Heart Failure, Vanderbilt Heart and Vascular Institute, Nashville, Tennessee.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Abraham', 'Affiliation': 'Division of Cardiovascular Medicine, The Ohio State University, Columbus.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Grayburn', 'Affiliation': 'Baylor University Medical Center, Baylor Heart and Vascular Institute, Dallas, Texas.'}, {'ForeName': 'Saibal', 'Initials': 'S', 'LastName': 'Kar', 'Affiliation': 'Center of Advanced Cardiac and Vascular Interventions, Los Angeles, California.'}, {'ForeName': 'Federico M', 'Initials': 'FM', 'LastName': 'Asch', 'Affiliation': 'MedStar Health Research Institute, Hyattsville, Maryland.'}, {'ForeName': 'D Scott', 'Initials': 'DS', 'LastName': 'Lim', 'Affiliation': 'Division of Cardiology, University of Virginia, Charlottesville.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Nie', 'Affiliation': 'Abbott, Santa Clara, California.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Singhal', 'Affiliation': 'Abbott, Santa Clara, California.'}, {'ForeName': 'Kartik S', 'Initials': 'KS', 'LastName': 'Sundareswaran', 'Affiliation': 'Abbott, Santa Clara, California.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Weissman', 'Affiliation': 'MedStar Health Research Institute, Hyattsville, Maryland.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Mack', 'Affiliation': 'Baylor Scott & White Heart Hospital Plano, Plano, Texas.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA cardiology,['10.1001/jamacardio.2020.7200'] 2047,33533688,"Positive Effects of Kangaroo Mother Care on Long-Term Breastfeeding Rates, Growth, and Neurodevelopment in Preterm Infants.","Background and Objectives: Kangaroo mother care (KMC) benefits preterm infants' health through increasing breastfeeding, but the longitudinal effects of KMC remain unknown. This study investigates the impact of KMC on breastfeeding and health outcomes in Chinese preterm infants. Methods: A longitudinal randomized controlled study was conducted with 79 preterm infant-mother dyads. The KMC group ( n  = 36) was provided 2.5 hours/day KMC during the neonatal intensive care unit (NICU) hospitalization, while the control group ( n  = 43) received standard care. Infant's feeding regimens and physical growth were documented daily at NICU. Physical growth and Neonatal Behavioral Neurological Assessment were measured at 40 weeks, 3 months, and 6 months of corrected age (CA). Breastfeeding outcomes were documented at 6 months of CA. Results: Compared with the control group, KMC infants received higher mothers' milk proportion during hospitalization ( B  = 0.16, confidence interval [CI] = [0.11-0.21]) and less feeding intolerance at discharge (odds ratio [OR] = 0.11, CI = [0.02-0.43]); and higher exclusive breastfeeding proportion (OR = 14.6, CI = [3.5-60.9]) at 6 months CA. KMC infants also had significant increased body weight and body length at hospital discharge; and more increases of body weight, body length, and head circumference in follow-ups. The neurobehavioral score was also higher in the KMC group compared to the control group over time. Conclusions: Longitudinal KMC effects are significant in promoting preterm infants' breastfeeding outcomes, growth, and neurodevelopment. Early initiation of KMC practice is highly recommended to the parent-infant population in Chinese NICUs to promote breastfeeding and developmental outcomes.",2021,"Compared with the control group, KMC infants received higher mothers' milk proportion during hospitalization ( B  = 0.16, confidence interval [CI] = [0.11-0.21]) and less feeding intolerance at discharge (odds ratio [OR] = 0.11, CI = [0.02-0.43]); and higher exclusive breastfeeding proportion (OR = 14.6, CI = [3.5-60.9]) at 6 months CA.","['Preterm Infants', 'Chinese preterm infants', '79 preterm infant-mother dyads']","['Kangaroo mother care (KMC', 'standard care', 'Kangaroo Mother Care', 'KMC']","['Physical growth and Neonatal Behavioral Neurological Assessment', 'body weight, body length, and head circumference', 'neurobehavioral score', 'breastfeeding and health outcomes', ""preterm infants' breastfeeding outcomes, growth, and neurodevelopment"", 'feeding intolerance at discharge', 'body weight and body length at hospital discharge', 'Long-Term Breastfeeding Rates, Growth, and Neurodevelopment']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C1257803', 'cui_str': 'Kangaroo-Mother Care'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0221097', 'cui_str': 'Length of body'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C1820738', 'cui_str': 'Feeding intolerance'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",79.0,0.0865375,"Compared with the control group, KMC infants received higher mothers' milk proportion during hospitalization ( B  = 0.16, confidence interval [CI] = [0.11-0.21]) and less feeding intolerance at discharge (odds ratio [OR] = 0.11, CI = [0.02-0.43]); and higher exclusive breastfeeding proportion (OR = 14.6, CI = [3.5-60.9]) at 6 months CA.","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neonatal Intensive Care Unit, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Zhao', 'Affiliation': 'School of Nursing, University of Connecticut, Storrs, Connecticut, USA.'}, {'ForeName': 'Yiming', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Statistics; University of Connecticut, Storrs, Connecticut, USA.'}, {'ForeName': 'Siying', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Neonatal Intensive Care Unit, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Cong', 'Affiliation': 'School of Nursing, University of Connecticut, Storrs, Connecticut, USA.'}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2020.0358'] 2048,33538306,"Fidelity and factors influencing implementation of Healthy Me, Healthy: process evaluation of a social marketing campaign for diet and physical activity behaviors of children in childcare.","The effectiveness of interventions targeting children's eating and physical activity behaviors through childcare settings is inconsistent. To enhance public health impact, it is imperative to evaluate fidelity of implementing complex interventions in real-world settings. This study evaluated fidelity and contextual factors influencing implementation of Healthy Me, Healthy We (HMHW). HMHW was an 8-month social marketing campaign delivered through childcare to support children's healthy eating and physical activity. HMHW required two levels of implementation support (research team and childcare providers) and two levels of campaign delivery (childcare providers and parents). Process evaluation was conducted among childcare centers in the intervention group (n=48) of the cluster-randomized control trial. Measures included attendance logs, self-report surveys, observation checklists, field notes, and semi-structured interviews. A 35-item fidelity index was created to assess fidelity of implementation support and campaign delivery. The fidelity with which HMHW was implemented by childcare providers and parents was low (mean 17.4 out of 35) and decreased between childcare providers and parents. Childcare providers had high acceptability of the program and individual components (80 - 93%). Only half of parents felt intervention components were acceptable. Frequently cited barriers to implementation by childcare providers included time constraints, parent engagement, staff turnover, and restrictive policies. The lack of observable effect of HMHW on children's dietary or physical activity behaviors may be due to inadequate implementation at multiple levels. Different or additional strategies are necessary to support implementation of multilevel interventions, particularly when individuals are expected to deliver intervention components and support others in doing so.",2021,Process evaluation was conducted among childcare centers in the intervention group (n=48) of the cluster-randomized control trial.,"['childcare centers in the intervention group (n=48) of the cluster-randomized control trial', 'children in childcare']","['HMHW', 'social marketing campaign']","['time constraints, parent engagement, staff turnover, and restrictive policies', 'attendance logs, self-report surveys, observation checklists, field notes, and semi-structured interviews']","[{'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0037424', 'cui_str': 'Social Marketing'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0031227', 'cui_str': 'Employee Turnover'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]",,0.0408251,Process evaluation was conducted among childcare centers in the intervention group (n=48) of the cluster-randomized control trial.,"[{'ForeName': 'Courtney T', 'Initials': 'CT', 'LastName': 'Luecking', 'Affiliation': 'Department of Dietetics and Human Nutrition, College of Agriculture, Food and Environment, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Amber E', 'Initials': 'AE', 'LastName': 'Vaughn', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Regan', 'Initials': 'R', 'LastName': 'Burney', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Hennink-Kaminski', 'Affiliation': 'Hussman School of Journalism and Media, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Hales', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Dianne S', 'Initials': 'DS', 'LastName': 'Ward', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Translational behavioral medicine,['10.1093/tbm/ibab001'] 2049,33536253,Rapid Changes in Serum Testosterone in Men With Newly Diagnosed Type 2 Diabetes With Intensive Insulin and Metformin.,"OBJECTIVE To investigate the effect of metformin on testosterone levels in men with type 2 diabetes mellitus (T2DM). RESEARCH DESIGN AND METHODS Seventy men with newly diagnosed drug-naive T2DM and HbA 1c >9.0% (75 mmol/mol) were treated with intensive insulin pump therapy for 5 days to achieve glucose normalization. They were randomized to control (continued on intensive insulin only) and metformin (plus metformin) groups (1:1) for 1 month. Testosterone was measured at baseline, randomization, and after 1-month treatment. RESULTS Total, free, and bioavailable testosterone increased significantly within 5 days (all P < 0.001). After 1 month, compared with the control group, the metformin group had lower total (12.7 vs. 15.3 nmol/L), free (0.20 vs. 0.24 nmol/L), and bioavailable (4.56 vs. 5.31 nmol/L) testosterone (all P < 0.05). CONCLUSIONS In men with T2DM, 1-month oral metformin may decrease serum testosterone levels independent of blood glucose control. The effects of long-term metformin on testosterone in men need further study.",2021,"RESULTS Total, free, and bioavailable testosterone increased significantly within 5 days (all P < 0.001).","['men with type 2 diabetes mellitus (T2DM', 'men need further study', 'Men with Newly Diagnosed Type 2 Diabetes With Intensive Insulin and Metformin', 'Seventy men with newly diagnosed drug-naive T2DM and HbA 1c']","['metformin', 'intensive insulin pump therapy', 'long-term metformin', 'metformin (plus metformin']","['serum testosterone levels', 'testosterone levels', 'Testosterone', 'Serum Testosterone', 'Total, free, and bioavailable testosterone']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0428413', 'cui_str': 'Serum testosterone measurement'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0370051', 'cui_str': 'Bioavailable testosterone'}]",70.0,0.0414633,"RESULTS Total, free, and bioavailable testosterone increased significantly within 5 days (all P < 0.001).","[{'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Jiangsu, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Ding', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Jiangsu, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Jiangsu, China.'}, {'ForeName': 'Reng-Na', 'Initials': 'RN', 'LastName': 'Yan', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Jiangsu, China.'}, {'ForeName': 'Feng-Fei', 'Initials': 'FF', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Jiangsu, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Sun', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Jiangsu, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Jing', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Jiangsu, China.'}, {'ForeName': 'Kok-Onn', 'Initials': 'KO', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Jian-Hua', 'Initials': 'JH', 'LastName': 'Ma', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Jiangsu, China majianhua196503@126.com.'}]",Diabetes care,['10.2337/dc20-1558'] 2050,33539981,Surgical Timing Does Not Interfere on Clinical Outcomes in Combined Reconstruction of the Anterior Cruciate Ligament and Anterolateral Ligament: A Comparative Study With Minimum 2-Year Follow-Up.,"PURPOSE To compare the functional outcomes, knee stability, failure rate and complication rates of combined anterior cruciate ligament (ACL) and anterolateral ligament (ALL) reconstruction with hamstrings grafts between acute and chronic cases. METHODS Consecutive patients who underwent combined ACL and ALL reconstruction with hamstrings grafts were evaluated. Patients operated on less than 8 weeks after injury were allocated to group 1, and the others were allocated to group 2. Demographic data, knee stability, and functional outcomes of the 2 groups were evaluated. RESULTS Thirty-four patients in the acute group and 96 in the chronic group were evaluated. The follow-up time was similar between the groups (28.7 ± 5.2 [24-43] months vs 29.4 ± 7.2 [24-58] months; P = 0.696). No differences were found between the groups in age, sex, trauma mechanism, presence of knee hyperextension, graft diameter, and meniscal injuries. There was no difference between the groups in the postoperative KT-1000 and in the pre- or postoperative pivot shift. The preoperative KT-1000 was higher in group 2 (7.9 ± 1.1 vs 7.4 ± 1.2; P = 0.031). There were no differences in the International Knee Documentation Committee or Lysholm. Three (2.3%) patients developed failure, 1 (2.9%) in group 1 and 2 (2.1%) in group 2. The total complication rate was 10% and did not differ between the groups. CONCLUSIONS Combined ACL and ALL reconstruction has similar outcomes in patients undergoing surgery in the acute and chronic phases. Patients with chronic injury have similar knee stability, functional scores, and failure rates as acute-injury patients, and patients with acute injury have no more complications than chronic patients. LEVEL OF EVIDENCE Level III, retrospective comparative therapeutic trial.",2021,There was no difference between the groups in the postoperative KT-1000 and in the pre- or postoperative pivot shift.,"['patients undergoing surgery in the acute and chronic phases', 'Patients with chronic injury', 'anterior cruciate ligament and anterolateral ligament', 'Consecutive patients who underwent', 'Thirty-four patients in the acute group and 96 in the chronic group', 'Patients operated on less than 8 weeks after injury']","['combined ACL and ALL reconstruction with hamstrings grafts', 'Combined ACL and ALL reconstruction', 'combined anterior cruciate ligament (ACL) and anterolateral ligament (ALL) reconstruction']","['preoperative KT-1000', 'Demographic data, knee stability and functional outcomes', 'functional outcomes, knee stability, failure rate and complication rates', 'total complication rate', 'postoperative KT-1000', 'knee stability, functional scores, and failure rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0332194', 'cui_str': 'Anterolateral'}, {'cui': 'C0023685', 'cui_str': 'Structure of ligament'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0332194', 'cui_str': 'Anterolateral'}, {'cui': 'C0547071', 'cui_str': 'Ligament reconstruction'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0023685', 'cui_str': 'Structure of ligament'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0251686,There was no difference between the groups in the postoperative KT-1000 and in the pre- or postoperative pivot shift.,"[{'ForeName': 'Camilo Partezani', 'Initials': 'CP', 'LastName': 'Helito', 'Affiliation': 'Grupo de Joelho, Instituto de Ortopedia e Traumatologia, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo; Hospital Sírio Libanês, São Paulo, Brazil.'}, {'ForeName': 'Marcel Faraco', 'Initials': 'MF', 'LastName': 'Sobrado', 'Affiliation': 'Grupo de Joelho, Instituto de Ortopedia e Traumatologia, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo; Hospital Sírio Libanês, São Paulo, Brazil. Electronic address: marcelfs@gmail.com.'}, {'ForeName': 'Pedro Nogueira', 'Initials': 'PN', 'LastName': 'Giglio', 'Affiliation': 'Grupo de Joelho, Instituto de Ortopedia e Traumatologia, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo.'}, {'ForeName': 'Marcelo Batista', 'Initials': 'MB', 'LastName': 'Bonadio', 'Affiliation': 'Grupo de Joelho, Instituto de Ortopedia e Traumatologia, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo.'}, {'ForeName': 'José Ricardo', 'Initials': 'JR', 'LastName': 'Pécora', 'Affiliation': 'Grupo de Joelho, Instituto de Ortopedia e Traumatologia, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo.'}, {'ForeName': 'Riccardo Gomes', 'Initials': 'RG', 'LastName': 'Gobbi', 'Affiliation': 'Grupo de Joelho, Instituto de Ortopedia e Traumatologia, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo.'}, {'ForeName': 'Gilberto Luis', 'Initials': 'GL', 'LastName': 'Camanho', 'Affiliation': 'Grupo de Joelho, Instituto de Ortopedia e Traumatologia, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2021.01.045'] 2051,33545940,Nursing intervention using healing touch in total knee replacement: A randomized controlled study protocol.,,2021,,['total knee replacement'],['Nursing intervention'],[],"[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.034695,,"[{'ForeName': 'Pingfang', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Department of nursing.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': 'Department of nursing.'}, {'ForeName': 'Chengfeng', 'Initials': 'C', 'LastName': 'Qiu', 'Affiliation': ""Department of Pharmacy, Huaihua First People's Hospital, Hunan, China.""}]",Medicine,['10.1097/MD.0000000000023735'] 2052,33549723,Early anterior cruciate ligament reconstruction does not affect 5 year change in knee cartilage thickness: secondary analysis of a randomized clinical trial.,"OBJECTIVE To compare 5-year change in femorotibial cartilage thickness in 121 young, active adults with an acute anterior cruciate ligament (ACL) tear randomized to a strategy of structured rehabilitation plus early ACL reconstruction (ACLR) or structured rehabilitation plus optional delayed ACLR. DESIGN 62 patients were randomized to early ACLR, 59 to optional delayed ACLR. Magnetic resonance imaging (MRI) was acquired within 4 weeks of injury, at two- and 5-years follow-up. Main outcome was 5-year change in overall femorotibial cartilage thickness. Secondary outcomes included the location-independent cartilage ChangeScore, summarizing thinning and thickening in 16 femorotibial subregions. An exploratory as-treated comparison was performed additionally. RESULTS Baseline and at least one follow-up MRI were available for 117 patients. Over 5 years, a comparable increase in overall femorotibial cartilage thickness was observed for patients randomized to early ACLR (n = 59) and patients randomized to optional delayed ACLR (n = 58, adjusted mean difference: -5 μm, 95% CI: [-118, 108]μm). However, the location-independent cartilage ChangeScore was greater in those treated with early ACLR than in patients treated with optional delayed ACLR (adjusted mean difference: 403 μm [119, 687]μm). As-treated analysis showed no between-group differences for the main outcome, while the location-independent cartilage ChangeScore was greater for patients treated with early (adjusted mean difference: 632 μm [268, 996]μm) or delayed ACLR (adjusted mean difference: 449 μm [108, 791]μm) than for patients treated with rehabilitation alone. CONCLUSIONS In young active adults with acute ACL-injury, choice of treatment strategy for the injured ACL did not modify the magnitude of 5-year change in overall femorotibial cartilage thickness. TRIAL REGISTRATION ISRCTN84752559.",2021,"Over five years, a comparable increase in overall femorotibial cartilage thickness was observed for patients randomized to early ACLR (n=59) and patients randomized to optional delayed ACLR (n=58, adjusted mean difference: -5μm, 95% CI: [-118, 108]μm).","['62 patients', '121 young, active adults with an acute anterior cruciate ligament (ACL', 'young active adults with acute ACL-injury']","['anterior cruciate ligament reconstruction', 'structured rehabilitation plus early ACL reconstruction (ACLR) or structured rehabilitation plus optional delayed ACLR']","['location-independent cartilage ChangeScore', 'delayed ACLR', 'knee cartilage thickness', 'overall femorotibial cartilage thickness', 'location-independent cartilage ChangeScore, summarizing thinning and thickening in 16 femorotibial subregions', 'femorotibial cartilage thickness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C1456574', 'cui_str': 'Injury of anterior cruciate ligament'}]","[{'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}]","[{'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205400', 'cui_str': 'Thickened'}]",62.0,0.164412,"Over five years, a comparable increase in overall femorotibial cartilage thickness was observed for patients randomized to early ACLR (n=59) and patients randomized to optional delayed ACLR (n=58, adjusted mean difference: -5μm, 95% CI: [-118, 108]μm).","[{'ForeName': 'W', 'Initials': 'W', 'LastName': 'Wirth', 'Affiliation': 'Department for Imaging & Functional Musculoskeletal Research, Institute of Anatomy & Cell Biology, Paracelsus Medical University Salzburg & Nuremberg, Salzburg, Austria; Ludwig Boltzmann Institute for Arthritis and Rehabilitation, Paracelsus Medical University, Salzburg, Austria; Chondrometrics GmbH, Ainring, Germany. Electronic address: wolfgang.wirth@pmu.ac.at.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Eckstein', 'Affiliation': 'Department for Imaging & Functional Musculoskeletal Research, Institute of Anatomy & Cell Biology, Paracelsus Medical University Salzburg & Nuremberg, Salzburg, Austria; Ludwig Boltzmann Institute for Arthritis and Rehabilitation, Paracelsus Medical University, Salzburg, Austria; Chondrometrics GmbH, Ainring, Germany. Electronic address: felix.eckstein@pmu.ac.at.'}, {'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Culvenor', 'Affiliation': 'Department for Imaging & Functional Musculoskeletal Research, Institute of Anatomy & Cell Biology, Paracelsus Medical University Salzburg & Nuremberg, Salzburg, Austria; La Trobe Sport & Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Bundoora, Australia. Electronic address: A.Culvenor@latrobe.edu.au.'}, {'ForeName': 'M I', 'Initials': 'MI', 'LastName': 'Hudelmaier', 'Affiliation': 'Department for Imaging & Functional Musculoskeletal Research, Institute of Anatomy & Cell Biology, Paracelsus Medical University Salzburg & Nuremberg, Salzburg, Austria. Electronic address: martin.hudelmaier@pmu.ac.at.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Stefan Lohmander', 'Affiliation': 'Department of Clinical Sciences Lund, Orthopaedics, Lund University, Lund, Sweden. Electronic address: stefan.lohmander@med.lu.se.'}, {'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Frobell', 'Affiliation': 'Department of Clinical Sciences Lund, Orthopaedics, Lund University, Lund, Sweden. Electronic address: richard.frobell@med.lu.se.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2021.01.004'] 2053,33548749,Effects of deep tissue massage on pain and comfort after cesarean: A randomized controlled trial.,"PURPOSE In this study, it was aimed to determine the effect of deep tissue massage (DTM) applied by midwife on pain and comfort after cesarean section. MATERIAL AND METHODS This study was designed as a randomized controlled trial conducted with experimental and control groups. The data were collected using a personal information form, visual analogue scale (VAS), the Postpartum Comfort Questionnaire (PPCQ). DTM was applied to participants in the experimental group twice (at the 10th and 22nd h) after cesarean. No applications were performed in the control group. RESULTS According to the measurements, the mean VAS score of the mother in the experimental group was lower than that of the control group (17.51 ± 6.15, 56.16 ± 9.53; respectively) and PPCQ total and sub-dimension mean scores were found to be statistically significant in favor of the experimental group (p < 0.001). CONCLUSIONS It was indicated that DTM application decreased the levels of pain and increased the comfort levels of the women who had cesarean sections.",2021,"According to the measurements, the mean VAS score of the mother in the experimental group was lower than that of the control group (17.51 ± 6.15, 56.16 ± 9.53; respectively) and PPCQ total and sub-dimension mean scores were found to be statistically significant in favor of the experimental group (p < 0.001). ",['after cesarean'],"['DTM', 'deep tissue massage (DTM', 'deep tissue massage']","['pain and comfort', 'visual analogue scale (VAS), the Postpartum Comfort Questionnaire (PPCQ', 'levels of pain', 'PPCQ total and sub-dimension mean scores', 'mean VAS score']",[],"[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",,0.0341934,"According to the measurements, the mean VAS score of the mother in the experimental group was lower than that of the control group (17.51 ± 6.15, 56.16 ± 9.53; respectively) and PPCQ total and sub-dimension mean scores were found to be statistically significant in favor of the experimental group (p < 0.001). ","[{'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Güney', 'Affiliation': 'Inonu University, Department of Midwifery, 44280 Malatya, Turkey. Electronic address: esra.guney@inonu.edu.tr.'}, {'ForeName': 'Tuba', 'Initials': 'T', 'LastName': 'Uçar', 'Affiliation': 'Inonu University, Department of Midwifery, 44280 Malatya, Turkey. Electronic address: tuba.ucar@inonu.edu.tr.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101320'] 2054,33548748,Clinical and phytochemical studies of Plantago major in pressure ulcer treatment: A randomized controlled trial.,"BACKGROUND Plantago major L. is used by local people to improve various wounds and lesions such as pressure ulcer. In this study, the therapeutic effects of P. major topical formulation on the stage 1 pressure ulcer in patients have been investigated. MATERIALS AND METHODS This randomized triple blind clinical trial study was performed on 130 patients. During the 14 days of study, each of the test and control groups was checked according to check list. Also the topical formulation was standardized by HPLC based on the amount of quercetin. RESULTS The findings of this study indicated a significant difference in resolution of the damage between the test and control groups. Topical formulation was standardized by HPLC based on the quercetin (1.88 mg/100g) and no side effects associated with this topical formulation was found. CONCLUSION The results confirmed the traditional use of P. major in resolution of the damage. CLINICAL TRIAL ID: (IRCT201609209014N117).",2021,"Topical formulation was standardized by HPLC based on the quercetin (1.88 mg/100g) and no side effects associated with this topical formulation was found. ",['130 patients'],[],[],"[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],[],130.0,0.0438995,"Topical formulation was standardized by HPLC based on the quercetin (1.88 mg/100g) and no side effects associated with this topical formulation was found. ","[{'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Ghiasian', 'Affiliation': 'Department of Neurology, School of Medicine, Hamadan University of Medical Science, Hamadan, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Niroomandi', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Medicinal Plants and Natural Products Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Dara', 'Initials': 'D', 'LastName': 'Dastan', 'Affiliation': 'Department of Pharmacognosy, School of Pharmacy, Medicinal Plants and Natural Products Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Jalal', 'Initials': 'J', 'LastName': 'Poorolajal', 'Affiliation': 'Department of Epidemiology, School of Public Health, Hamadan University of Medical Science, Hamadan, Iran.'}, {'ForeName': 'Fateme', 'Initials': 'F', 'LastName': 'Zare', 'Affiliation': 'Department of Neurology, School of Medicine, Hamadan University of Medical Science, Hamadan, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ataei', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Medicinal Plants and Natural Products Research Center, Hamadan University of Medical Sciences, Hamadan, Iran. Electronic address: s.ataei@umsha.ac.ir.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101325'] 2055,33821837,Effect of preoperative subanaesthetic ketamine on postoperative pain in women undergoing modified radical mastectomy: A randomised control trial.,,2021,,['women undergoing modified radical mastectomy'],['preoperative subanaesthetic ketamine'],['postoperative pain'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",,0.36551,,"[{'ForeName': 'Bhukya Mohan', 'Initials': 'BM', 'LastName': 'Nayak', 'Affiliation': 'From the Department of Anesthesiology and Critical Care, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, Bhubaneswar, Odisha 751019, India (BMN, SM, JKM, AKS).'}, {'ForeName': 'Satyajeet', 'Initials': 'S', 'LastName': 'Misra', 'Affiliation': ''}, {'ForeName': 'Jayanta Kumar', 'Initials': 'JK', 'LastName': 'Mitra', 'Affiliation': ''}, {'ForeName': 'Alok Kumar', 'Initials': 'AK', 'LastName': 'Sahoo', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001336'] 2056,33821835,General anaesthesia with desflurane or propofol in lung volume reduction surgery: Results of an unpublished randomised clinical trial.,,2021,,['lung volume reduction surgery'],['desflurane or propofol'],[],"[{'cui': 'C0375931', 'cui_str': 'Lung volume reduction surgery'}]","[{'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]",[],,0.0998527,,"[{'ForeName': 'Bessie', 'Initials': 'B', 'LastName': 'Kachulis', 'Affiliation': 'From the Department of Anesthesiology, Weill Cornell Medicine, New York, New York (BK), Department of Anesthesiology, Cooper University Healthcare, One Cooper Plaza, Camden, New Jersey (LM), Division of Biostatistics, Department of Population Health Sciences, New York, New York (IE) and Department of Anesthesiology & Perioperative Medicine, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA (BM).'}, {'ForeName': 'Ludmil', 'Initials': 'L', 'LastName': 'Mitrev', 'Affiliation': ''}, {'ForeName': 'Imaani', 'Initials': 'I', 'LastName': 'Easthausen', 'Affiliation': ''}, {'ForeName': 'Berend', 'Initials': 'B', 'LastName': 'Mets', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001328'] 2057,33517104,"The comparative effects of spinal manipulation, myofascial release and exercise in tension-type headache patients with neck pain: A randomized controlled trial.","OBJECTIVES To evaluate the effects of two manual treatment methods on pain, disability, and pressure pain threshold (PPT) in tension-type headache (TTH) patients with and neck pain. METHODS Forty-five patients with TTH were randomly assigned to one of three groups and received eight sessions treatment: manipulation plus exercise (manipulation), suboccipital inhibition plus exercise (myofascial release), and exercise only (control). Headache frequency, pain severity (VAS-headache, VAS-neck pain) and headache and neck disability (HIT-6 and NDI, respectively) were measured at baseline, posttreatment, and at the third month follow-up. PPT was also evaluated on the temporalis muscle. RESULTS Manipulation group was statistically better than myofascial release group in terms of headache frequency, headache severity, and PPT scores. Also, manipulation group showed statistically significant improvements in all outcome criteria when compared control group. CONCLUSIONS Manipulation and exercise, in addition to pharmacologic treatment in TTH patients with cervical dysfunction appear to be a promising approach.",2021,"RESULTS Manipulation group was statistically better than myofascial release group in terms of headache frequency, headache severity, and PPT scores.","['Forty-five patients with TTH', 'tension-type headache (TTH) patients with and neck pain', 'TTH patients with cervical dysfunction', 'tension-type headache patients with neck pain']","['spinal manipulation, myofascial release and exercise', 'eight sessions treatment: manipulation plus exercise (manipulation), suboccipital inhibition plus exercise (myofascial release), and exercise only (control']","['Headache frequency, pain severity (VAS-headache, VAS-neck pain) and headache and neck disability (HIT-6 and NDI, respectively', 'pain, disability, and pressure pain threshold (PPT', 'headache frequency, headache severity, and PPT scores']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033893', 'cui_str': 'Psychogenic headache'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]","[{'cui': 'C0086586', 'cui_str': 'Manipulation of spine'}, {'cui': 'C0695600', 'cui_str': 'Myofascial release'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0442187', 'cui_str': 'Suboccipital approach'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C1563705', 'cui_str': 'Diabetes Insipidus, Nephrogenic, Type I'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",45.0,0.0458596,"RESULTS Manipulation group was statistically better than myofascial release group in terms of headache frequency, headache severity, and PPT scores.","[{'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Corum', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul Physical Medicine and Rehabilitation Training and Research Hospital, Istanbul, Turkey. Electronic address: mustafacorum@gmail.com.'}, {'ForeName': 'Tugba', 'Initials': 'T', 'LastName': 'Aydin', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul Physical Medicine and Rehabilitation Training and Research Hospital, Istanbul, Turkey. Electronic address: drtugbaaydin@gmail.com.'}, {'ForeName': 'Cansın', 'Initials': 'C', 'LastName': 'Medin Ceylan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul Physical Medicine and Rehabilitation Training and Research Hospital, Istanbul, Turkey. Electronic address: cansinmedin@hotmail.com.'}, {'ForeName': 'Fatma Nur', 'Initials': 'FN', 'LastName': 'Kesiktas', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul Physical Medicine and Rehabilitation Training and Research Hospital, Istanbul, Turkey. Electronic address: nur.kesiktas@gmail.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101319'] 2058,33517103,Green tea extract for mild-to-moderate diabetic peripheral neuropathy A randomized controlled trial.,"BACKGROUND AND AIM This randomized study aimed to evaluate the effect of green tea extract (GTE) intake on clinical and neurophysiological parameters in patients with mild-to-moderate diabetic peripheral neuropathy (DPN). PATIENTS AND METHODS The present study included 194 patients with DPN. Patients were randomized into two treatment arms: GTE (n = 96) and placebo (n = 98) arms who received allocated treatment for 16 weeks. Symptoms of DPN were assessed using Toronto Clinical Scoring System (TCSS). Sensorineural pain was assessed using visual analog scale (VAS). Neural dysfunction was evaluated using the vibration perception thresholds (VPT). Assessments were made at baseline and after 4, 8, and 16 weeks of starting treatment. RESULTS At baseline and after 4 weeks of treatment, VAS, TCSS and VPT were comparable in the studied groups. However, after 8 weeks of treatment, patients in GTE group expressed lower VAS scores, significantly lower TCSS scores and significantly lower VPT. As treatment continued, the differences between groups regarding the outcome parameters became more evident at 16 weeks. CONCLUSIONS GTE intake may have a beneficial value in treatment of DPN.",2021,"However, after 8 weeks of treatment, patients in GTE group expressed lower VAS scores, significantly lower TCSS scores and significantly lower VPT.","['194 patients with DPN', 'mild-to-moderate diabetic peripheral neuropathy', 'patients with mild-to-moderate diabetic peripheral neuropathy (DPN']","['GTE', 'placebo', 'green tea extract (GTE) intake', 'Green tea extract']","['Sensorineural pain', 'VAS, TCSS and VPT', 'vibration perception thresholds (VPT', 'Symptoms of DPN', 'Neural dysfunction', 'VAS scores', 'visual analog scale (VAS', 'TCSS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0740447', 'cui_str': 'Diabetic peripheral neuropathy'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C1704263', 'cui_str': 'Green Tea Extract'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0740447', 'cui_str': 'Diabetic peripheral neuropathy'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",194.0,0.185216,"However, after 8 weeks of treatment, patients in GTE group expressed lower VAS scores, significantly lower TCSS scores and significantly lower VPT.","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Essmat', 'Affiliation': 'Department of Neurology, Al-Azhar University, Faculty of Medicine, Cairo, Egypt. Electronic address: ahmadesmat81@yahoo.com.'}, {'ForeName': 'Mohammed Salah', 'Initials': 'MS', 'LastName': 'Hussein', 'Affiliation': 'Internal Medicine Department, Al-Azhar University, Faculty of Medicine, Cairo, Egypt.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101317'] 2059,33524608,The effect of flavor on the oral perception and palatability of viscosity in healthy human subjects.,"OBJECTIVES Thickeners are frequently used in various foods, including ice cream and sauces, to impart viscosity. Generally, viscous foods have some flavor (smell and taste). In this study, we examined the effects of flavor on the oral perception and palatability of viscosity in humans. METHODS Viscous fluids were prepared by adding the commercial thickener Tsururinko® (0.5 and 3.0%) to water and apple juice, which were used as the control and flavor fluids, respectively. The viscosity and palatability perception of the test fluids were evaluated in nine healthy volunteers using a visual analog scale. In the other seven volunteers, fluid viscosities were measured before and after spitting following retention in the mouth for 5 s to investigate the dilution of viscous fluids by flavor-stimulated saliva. RESULTS With 1.5% Tsururinko®, there was no difference between the physical viscosity of water and apple juice, but the perceived viscosity of apple juice was significantly lower than that of water. With 3.0% Tsururinko®, the viscosity of apple juice was significantly higher than that of water, but the perceived viscosities did not differ significantly. The addition of Tsururinko® reduced palatability in water in a dose-dependent manner. Apple juice suppressed this Tsururinko®-induced reduction. The reduction in viscosity after spitting was significantly larger in apple juice than in water. CONCLUSION Our results suggest that a favorable flavor reduces the perception of oral viscosity, which is due to mixing with stimulated saliva, and suppresses the unpalatability of thickeners.",2021,"With 3.0% Tsururinko®, the viscosity of apple juice was significantly higher than that of water, but the perceived viscosities did not differ significantly.","['nine healthy volunteers using a visual analog scale', 'healthy human subjects', 'humans']",['flavor'],"['reduction in viscosity', 'perceived viscosity of apple juice', 'fluid viscosities', 'physical viscosity of water and apple juice', 'perception of oral viscosity', 'viscosity of apple juice', 'viscosity and palatability perception', 'oral perception and palatability of viscosity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0452454', 'cui_str': 'Apple juice'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]",9.0,0.0219805,"With 3.0% Tsururinko®, the viscosity of apple juice was significantly higher than that of water, but the perceived viscosities did not differ significantly.","[{'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Nakatomi', 'Affiliation': 'Division of Physiology, Kyushu Dental University, 2-6-1 Manazuru, Kokurakita-ku, Kitakyushu, Fukuoka, 803-8580, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Yoshino', 'Affiliation': 'Section of Primary Dental Education, Kyushu Dental University, 2-6-1 Manazuru, Kokurakita-ku, Kitakyushu, Fukuoka, 803-8580, Japan.'}, {'ForeName': 'Yukine', 'Initials': 'Y', 'LastName': 'Shono', 'Affiliation': 'Section of Primary Dental Education, Kyushu Dental University, 2-6-1 Manazuru, Kokurakita-ku, Kitakyushu, Fukuoka, 803-8580, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Miyamura', 'Affiliation': 'Division of Oral and Maxillofacial Radiology, Kyushu Dental University, 2-6-1 Manazuru, Kokurakita-ku, Kitakyushu, Fukuoka, 803-8580, Japan.'}, {'ForeName': 'Suzuro', 'Initials': 'S', 'LastName': 'Hitomi', 'Affiliation': 'Division of Physiology, Kyushu Dental University, 2-6-1 Manazuru, Kokurakita-ku, Kitakyushu, Fukuoka, 803-8580, Japan.'}, {'ForeName': 'Izumi', 'Initials': 'I', 'LastName': 'Ujihara', 'Affiliation': 'Division of Physiology, Kyushu Dental University, 2-6-1 Manazuru, Kokurakita-ku, Kitakyushu, Fukuoka, 803-8580, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Ono', 'Affiliation': 'Division of Physiology, Kyushu Dental University, 2-6-1 Manazuru, Kokurakita-ku, Kitakyushu, Fukuoka, 803-8580, Japan. Electronic address: ono@kyu-dent.ac.jp.'}]",Journal of oral biosciences,['10.1016/j.job.2021.01.008'] 2060,33526855,Six-month changes in ghrelin and glucagon-like peptide-1 with weight loss are unrelated to long-term weight regain in obese older adults.,"BACKGROUND AND OBJECTIVE Weight loss (WL) and subsequent regain are complex physiologic processes, and our understanding of the hormonal changes associated with these processes continues to evolve. We aimed to examine the effects of behavioral WL on 6-month changes in ghrelin and GLP-1 and evaluate the effects of these changes in gut hormones on weight regain among older adults. SUBJECTS AND METHODS One hundred seventy-seven obese (BMI: 33.5 (3.5) kg/m 2 ) older adults (66.9 ± 4.7 years, 71.2% female, 67.6% white) were randomized to WL (WL; n = 68), WL plus aerobic training (n = 79), or WL plus resistance training (n = 75) for 18 months. Ghrelin, GLP-1, power of food scale (PFS), and weight were measured at baseline, 6 months, and 18 months. RESULTS There was no differential treatment effect on change in either gut hormone, however, there was a significant time effect across all groups (p < 0.001), with increases in ghrelin (∆ = +106.77 pg/ml; 95% CI = + 84.82, +128.71) and decreases in GLP-1 (∆ = -4.90 pM; 95% CI = -6.27, -3.51) at 6-month. Ratings on the PFS decreased from baseline to 6-month and there was significant loss of weight from baseline to either 6- or 18-month, ∆ = -7.96 kg; 95% CI = -7.95, -8.78 and ∆ = -7.80 kg; 95% CI = -8.93, -6.65, respectively (p < 0.001). Changes in ghrelin and GLP-1 at 6-month did not predict weight regain from 6- to 18-month. DISCUSSION AND CONCLUSION Among older adults with obesity and cardiometabolic disease, the intensive phase of dietary WL results in increasing levels of ghrelin and decreasing levels of GLP-1 that are unrelated to weight regain a year later. Registered with ClinicalTrials.gov (NCT01547182).",2021,"Ratings on the PFS decreased from baseline to 6-month and there was significant loss of weight from baseline to either 6- or 18-month, ∆ = -7.96 kg; 95% CI = -7.95, -8.78 and ∆ = -7.80 kg; 95% CI = -8.93, -6.65, respectively (p < 0.001).","['older adults', 'One hundred seventy-seven obese', 'obese older adults', 'BMI: 33.5 (3.5) kg/m 2 ) older adults (66.9\u2009±\u20094.7 years, 71.2% female, 67.6% white', 'older adults with obesity and cardiometabolic disease']","['WL plus aerobic training (n\u2009=\u200979), or WL plus resistance training']","['PFS', 'GLP-1', 'weight regain', 'loss of weight', 'Ghrelin, GLP-1, power of food scale (PFS), and weight']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}]",177.0,0.0764704,"Ratings on the PFS decreased from baseline to 6-month and there was significant loss of weight from baseline to either 6- or 18-month, ∆ = -7.96 kg; 95% CI = -7.95, -8.78 and ∆ = -7.80 kg; 95% CI = -8.93, -6.65, respectively (p < 0.001).","[{'ForeName': 'Jared J', 'Initials': 'JJ', 'LastName': 'Rejeski', 'Affiliation': 'Department of Internal Medicine, Section on Gastroenterology, Wake Forest School of Medicine, Winston-Salem, NC, USA. jarejesk@wakehealth.edu.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Fanning', 'Affiliation': 'Department of Health & Exercise Science, Wake Forest University, Winston-Salem, NC, USA.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Nicklas', 'Affiliation': 'Department of Internal Medicine, Section on Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'W Jack', 'Initials': 'WJ', 'LastName': 'Rejeski', 'Affiliation': 'Department of Health & Exercise Science, Wake Forest University, Winston-Salem, NC, USA.'}]",International journal of obesity (2005),['10.1038/s41366-021-00754-0'] 2061,33529620,Effect of Obesity on Response to Spironolactone in Patients With Heart Failure With Preserved Ejection Fraction.,"Obesity is common in heart failure with preserved ejection fraction (HFpEF). Whether obesity modifies the response to spironolactone in patients with HFpEF remains unclear. We aimed to investigate the effect of obesity, defined by body mass index (BMI) and waist circumference (WC), on response to spironolactone in patients with HFpEF enrolled in Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist trial. This was a post-hoc, exploratory analysis of the Americas cohort of Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist trial. BMI≥30 kg/m2 was used to define the obese group and WC≥102 cm in men and ≥88 cm in women were defined as high WC. In separate analyses, BMI and WC were treated as continuous variables. The effect of spironolactone versus placebo on outcomes was calculated by BMI and WC using Cox proportional hazard models. Obese patients were younger and had more co-morbidities. In multivariate analysis, spironolactone use was associated with a significant reduction in the primary end point, compared with placebo in obese [hazard ratio (HR = 0.618, 95% CI 0.460 to 0.831, p = 0.001), but not in nonobese subjects (HR = 0.946, 95% CI 0.623 to 1.437, p = 0.796; p for interaction = 0.056). There was a linear association between continuous BMI and the effect of spironolactone, with the effect becoming significant at 33kg/m 2 . Similar results were obtained for the WC-based analysis. In conclusion, use of spironolactone in obese patients with HFpEF was associated with a decreased risk of the primary end point, cardiovascular death and HF hospitalizations, compared with placebo. Further prospective randomized studies in obese subjects are required.",2021,"In multivariate analysis, spironolactone use was associated with a significant reduction in the primary endpoint, compared to placebo in obese [hazard ratio (HR=0.618, 95% CI 0.460-0.831, p=0.001), but not in non-obese subjects (HR=0.946, 95% CI 0.623-1.437, p=0.796; p for interaction=0.056).","['patients with HFpEF enrolled in TOPCAT (Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist) trial', 'Patients with Heart Failure with Preserved Ejection Fraction', 'obese patients with HFpEF', 'obese subjects', 'patients with HFpEF', 'Obese patients were younger and had more comorbidities']","['placebo', 'spironolactone', 'BMI≥30', 'spironolactone vs. placebo', 'Spironolactone']","['body mass index (BMI) and waist circumference (WC', 'cardiovascular death and HF hospitalizations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0002007', 'cui_str': 'Aldosterone receptor antagonist-containing product'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",,0.123759,"In multivariate analysis, spironolactone use was associated with a significant reduction in the primary endpoint, compared to placebo in obese [hazard ratio (HR=0.618, 95% CI 0.460-0.831, p=0.001), but not in non-obese subjects (HR=0.946, 95% CI 0.623-1.437, p=0.796; p for interaction=0.056).","[{'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Elkholey', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Lampros', 'Initials': 'L', 'LastName': 'Papadimitriou', 'Affiliation': 'University of Mississippi Medical Center, Jackson, Mississippi.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'University of Mississippi Medical Center, Jackson, Mississippi.'}, {'ForeName': 'Udho', 'Initials': 'U', 'LastName': 'Thadani', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Stavrakis', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma. Electronic address: stavros-stavrakis@ouhsc.edu.'}]",The American journal of cardiology,['10.1016/j.amjcard.2021.01.018'] 2062,33533139,The effect of acute-experimental pain models on offset analgesia.,"BACKGROUND Offset analgesia (OA) is characterized by a disproportionately large decrease in pain perception after a slight decrease in noxious stimulation. In patients with ongoing pain, this response is reduced. The effect is pronounced in painful body areas. The influence of acute pain has not been sufficiently investigated. The aim of this study was to investigate the influence of two experimental acute pain models, measured within the area of acute pain and on the non-affected opposite side, thereby considering the possible somatotopic nature of OA. METHODS Healthy, pain-free volunteers (n = 75) were randomly assigned to one of three groups (cold water, exercise and control group). The 'cold water group' immersed one hand into cold water for 3 min (Cold Pressor Task), while the 'exercise group' performed an isometric grip exercise for 3 min. There was no manipulation in the control group. Each experimental pain stimulus was performed at both (dominant, non-dominant) forearms. The individualized OA paradigm consisted of offset and constant temperature trials. Offset analgesia was measured immediately before, during and after the experimental pain stimuli. RESULTS A significant difference in OA was shown during experimental pain when compared to the control condition (exercise vs. control: p < 0.001, cold vs. control: p = 0.001), with no difference between the experimental conditions (p > 0.05). Immediately following the pain stimulation, results were marginally non-significant (p = 0.05). CONCLUSIONS Experimental painful stimulation reduced OA. This result should be interpreted with caution due to potential influences of conditioned pain modulation or exercise-induced hypoalgesia as well as possible floor effects. SIGNIFICANCE Temporal contrast of pain perception is inhibited in acute pain states. This study showed that reduced offset analgesia is observed when pain is experimentally induced using noxious cold and exercise stimuli.",2021,"A significant difference in OA was shown during experimental pain when compared to the control condition (exercise vs. control: p<0.001, cold vs. control: p=0.001), with no difference between the experimental conditions (p>0.05).","['Healthy, pain-free volunteers (n = 75']","['exercise group"" performed an isometric grip exercise']","['OA', 'pain perception', 'Offset analgesia']","[{'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0454331', 'cui_str': 'Gripping exercises'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",75.0,0.0504037,"A significant difference in OA was shown during experimental pain when compared to the control condition (exercise vs. control: p<0.001, cold vs. control: p=0.001), with no difference between the experimental conditions (p>0.05).","[{'ForeName': 'Tibor M', 'Initials': 'TM', 'LastName': 'Szikszay', 'Affiliation': 'Department of Physiotherapy, Pain and Exercise Research Luebeck (P. E. R. L.), Institute of Health Sciences, University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Waclaw M', 'Initials': 'WM', 'LastName': 'Adamczyk', 'Affiliation': 'Department of Physiotherapy, Pain and Exercise Research Luebeck (P. E. R. L.), Institute of Health Sciences, University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Hoegner', 'Affiliation': 'Department of Physiotherapy, Pain and Exercise Research Luebeck (P. E. R. L.), Institute of Health Sciences, University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Nele', 'Initials': 'N', 'LastName': 'Woermann', 'Affiliation': 'Department of Physiotherapy, Pain and Exercise Research Luebeck (P. E. R. L.), Institute of Health Sciences, University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Luedtke', 'Affiliation': 'Department of Physiotherapy, Pain and Exercise Research Luebeck (P. E. R. L.), Institute of Health Sciences, University of Luebeck, Luebeck, Germany.'}]","European journal of pain (London, England)",['10.1002/ejp.1740'] 2063,33537760,Branched-Chain Amino Acid Supplementation Does Not Preserve Lean Mass or Affect Metabolic Profile in Adults with Overweight or Obesity in a Randomized Controlled Weight Loss Intervention.,"BACKGROUND Branched-chain amino acid (BCAA) supplementation has been shown to increase muscle mass or prevent muscle loss during weight loss. OBJECTIVE We aimed to investigate the effects of a BCAA-supplemented hypocaloric diet on lean mass preservation and insulin sensitivity. METHODS A total of 132 Chinese adults (63 men and 69 women aged 21-45 y, BMI 25-36 kg/m2) were block randomly assigned by gender and BMI into 3 hypocaloric diet (deficit of 500 kcal/d) groups: standard-protein (14%) with placebo (control, CT) or BCAA supplements at 0.1 g · kg-1 body weight · d-1 (BCAA) or high-protein (27%) with placebo (HP). The subjects underwent 16 wk of dietary intervention with provision of meals and supplements, followed by 8 wk of weight maintenance with provision of supplements only. One-way ANOVA analysis was conducted to analyze the primary (lean mass and insulin sensitivity) and secondary outcomes (anthropometric and metabolic parameters) among the 3 groups. Paired t-test was used to analyze the change in each group. RESULTS The 3 groups demonstrated similar significant reductions in body weight (7.97%), fat mass (13.8%), and waist circumference (7.27%) after 16 wk of energy deficit. Lean mass loss in BCAA (4.39%) tended to be lower than in CT (5.39%) and higher compared with HP (3.67%) (P = 0.06). Calf muscle volume increased 3.4% in BCAA and intramyocellular lipids (IMCLs) decreased in BCAA (17%) and HP (18%) (P < 0.05) over 16 wk. During the 8 wk weight maintenance period, lean mass gain in BCAA (1.03%) tended to be lower compared with CT (1.58%) and higher than in HP (-0.002%) (P = 0.04). Lean mass gain differed significantly between CT and HP (P = 0.03). Insulin sensitivity and metabolic profiles did not differ among the groups throughout the study period. CONCLUSIONS BCAA supplementation does not preserve lean mass or affect insulin sensitivity in overweight and obese adults during weight loss. A higher protein diet may be more advantageous for lean mass preservation.",2021,"The 3 groups demonstrated similar significant reductions in body weight (7.97%), fat mass (13.8%), and waist circumference (7.27%) after 16 wk of energy deficit.","['132 Chinese adults (63 men and 69 women aged 21-45 y, BMI 25-36\xa0kg/m2', 'Adults with Overweight or Obesity']","['Branched-chain amino acid (BCAA) supplementation', 'dietary intervention with provision of meals and supplements', 'standard-protein (14%) with placebo (control, CT) or BCAA supplements at 0.1', 'Branched-Chain Amino Acid Supplementation', 'placebo (HP', 'BCAA supplementation', 'BCAA-supplemented hypocaloric diet']","['Calf muscle volume', 'intramyocellular lipids (IMCLs', 'Lean mass loss in BCAA', 'BCAA', 'fat mass', 'body weight', 'Lean mass gain', 'waist circumference', 'Insulin sensitivity and metabolic profiles']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0556085', 'cui_str': 'Branched chain amino acid supplementation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0448482', 'cui_str': 'Posterior crural muscle structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}]",132.0,0.21972,"The 3 groups demonstrated similar significant reductions in body weight (7.97%), fat mass (13.8%), and waist circumference (7.27%) after 16 wk of energy deficit.","[{'ForeName': 'Delicia S Q', 'Initials': 'DSQ', 'LastName': 'Ooi', 'Affiliation': 'Department of Paediatrics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Jennifer Q R', 'Initials': 'JQR', 'LastName': 'Ling', 'Affiliation': 'Department of Paediatrics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Suresh Anand', 'Initials': 'SA', 'LastName': 'Sadananthan', 'Affiliation': 'Clinical Nutrition Research Center, Singapore Institute for Clinical Sciences, Agency for Science, Technology and Research, Singapore.'}, {'ForeName': 'S Sendhil', 'Initials': 'SS', 'LastName': 'Velan', 'Affiliation': 'Clinical Nutrition Research Center, Singapore Institute for Clinical Sciences, Agency for Science, Technology and Research, Singapore.'}, {'ForeName': 'Fang Yi', 'Initials': 'FY', 'LastName': 'Ong', 'Affiliation': 'Department of Paediatrics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Chin Meng', 'Initials': 'CM', 'LastName': 'Khoo', 'Affiliation': 'Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'E Shyong', 'Initials': 'ES', 'LastName': 'Tai', 'Affiliation': 'Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Christiani Jeyakumar', 'Initials': 'CJ', 'LastName': 'Henry', 'Affiliation': 'Clinical Nutrition Research Center, Singapore Institute for Clinical Sciences, Agency for Science, Technology and Research, Singapore.'}, {'ForeName': 'Melvin K S', 'Initials': 'MKS', 'LastName': 'Leow', 'Affiliation': 'Clinical Nutrition Research Center, Singapore Institute for Clinical Sciences, Agency for Science, Technology and Research, Singapore.'}, {'ForeName': 'Eric Y H', 'Initials': 'EYH', 'LastName': 'Khoo', 'Affiliation': 'Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Chuen Seng', 'Initials': 'CS', 'LastName': 'Tan', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore.'}, {'ForeName': 'Yung Seng', 'Initials': 'YS', 'LastName': 'Lee', 'Affiliation': 'Department of Paediatrics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Mary F F', 'Initials': 'MFF', 'LastName': 'Chong', 'Affiliation': 'Clinical Nutrition Research Center, Singapore Institute for Clinical Sciences, Agency for Science, Technology and Research, Singapore.'}]",The Journal of nutrition,['10.1093/jn/nxaa414'] 2064,33541457,Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) vs . a licensed quadrivalent meningococcal tetanus toxoid-conjugate vaccine in meningococcal vaccine-naïve and meningococcal C conjugate vaccine-primed toddlers: a phase III randomised study.,"Vaccination remains the best strategy to reduce invasive meningococcal disease. This study evaluated an investigational tetanus toxoid-conjugate quadrivalent meningococcal vaccine (MenACYW-TT) vs. a licensed tetanus toxoid-conjugate quadrivalent meningococcal vaccine (MCV4-TT) (NCT02955797). Healthy toddlers aged 12-23 months were included if they were either meningococcal vaccine-naïve or MenC conjugate (MCC) vaccine-primed (≥1 dose of MCC prior to 12 months of age). Vaccine-naïve participants were randomised 1:1 to either MenACYW-TT (n = 306) or MCV4-TT (n = 306). MCC-primed participants were randomised 2:1 to MenACYW-TT (n = 203) or MCV4-TT (n = 103). Antibody titres against each of the four meningococcal serogroups were measured by serum bactericidal antibody assay using the human complement. The co-primary objectives of this study were to demonstrate the non-inferiority of MenACYW-TT to MCV4-TT in terms of seroprotection (titres ≥1:8) at Day 30 in both vaccine-naïve and all participants (vaccine-naïve and MCC-primed groups pooled). The immune response for all four serogroups to MenACYW-TT was non-inferior to MCV4-TT in vaccine-naïve participants (seroprotection: range 83.6-99.3% and 81.4-91.6%, respectively) and all participants (seroprotection: range 83.6-99.3% and 81.4-98.0%, respectively). The safety profiles of both vaccines were comparable. MenACYW-TT was well-tolerated and demonstrated non-inferior immunogenicity when administered to MCC vaccine-primed and vaccine-naïve toddlers.",2021,,['Primed Toddlers'],"['Meningococcal C Conjugate Vaccine', 'Quadrivalent Meningococcal Tetanus Toxoid-Conjugate Vaccine', 'Quadrivalent Meningococcal Tetanus Toxoid-Conjugate Vaccine (MenACYW-TT']",['Immunogenicity and Safety'],"[{'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}]","[{'cui': 'C0915344', 'cui_str': 'Meningococcal C conjugate vaccine'}, {'cui': 'C0127526', 'cui_str': 'Meningococcal polysaccharide vaccine'}, {'cui': 'C0039620', 'cui_str': 'Tetanus vaccine'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.044069,,"[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'van der Vliet', 'Affiliation': ""Sanofi Pasteur, Marcy l'Etoile, France.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Vesikari', 'Affiliation': 'Vaccine Research Center, University of Tampere, Tampere, Finland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Sandner', 'Affiliation': ""NETSTAP (Network of children's physicians for clinical trials in the ambulant pediatrics), Aschaffenburg, Germany.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Martinón-Torres', 'Affiliation': 'Translational Pediatrics and Infectious Diseases, Pediatrics Department, Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Muzsay', 'Affiliation': 'Gyor-Marcal Város II. sz. Gyermekorvosi Rendelő, Pediatrics, Győr, Hungary.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Forsten', 'Affiliation': 'Vaccine Research Center, University of Tampere, Tampere, Finland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Adelt', 'Affiliation': ""Pediatric practice, Bramsche, in cooperation with NETSTAP (Network of Children's Physicians for clinical trials in the ambulant pediatrics), Germany.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Diaz Gonzalez', 'Affiliation': 'Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Simko', 'Affiliation': 'Futurenest Clinical Research, Miskolc, Hungary.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': ""B'Chir"", 'Affiliation': ""Sanofi Pasteur, Marcy l'Etoile, France.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Neveu', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Jordanov', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Dhingra', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}]",Epidemiology and infection,['10.1017/S0950268821000261'] 2065,33539734,"Chlorhexidine plus alcohol versus povidone iodine plus alcohol, combined or not with innovative devices, for prevention of short-term peripheral venous catheter infection and failure (CLEAN 3 study): an investigator-initiated, open-label, single centre, randomised-controlled, two-by-two factorial trial.","BACKGROUND Two billion peripheral venous catheters are sold globally each year, but the optimal skin disinfection and types of devices are not well established. We aimed to show the superiority of disinfection with 2% chlorhexidine plus alcohol over 5% povidone iodine plus alcohol in preventing infectious complications, and of closed integrated catheters, positive displacement needleless-connectors, disinfecting caps, and single-use prefilled flush syringes used in combination (innovation group) over open catheters and three-way stopcocks for treatment administration (standard group) in preventing catheter failure. METHODS We did an open-label, randomised-controlled trial with a two-by-two factorial design, for which we enrolled adults (age ≥18 years) visiting the emergency department at the Poitiers University Hospital, France, and requiring one peripheral venous catheter before admission to the medical wards. Before catheter insertion, patients were randomly assigned (1:1:1:1) using a secure web-based random-number generator to one of four treatment groups based on skin preparation and type of devices (innovative devices or standard devices; 2% chlorhexidine plus alcohol or 5% povidone iodine plus alcohol). Primary outcomes were the incidence of infectious complications (local infection, catheter colonisation, or bloodstream infections) and time between catheter insertion and catheter failure (occlusion, dislodgment, infiltration, phlebitis, or infection). This study is registered with ClinicalTrials.gov, NCT03757143. FINDINGS 1000 patients were recruited between Jan 7, and Sept 6, 2019, of whom 500 were assigned to the chlorhexidine plus alcohol group and 500 to the povidone iodine plus alcohol group (250 with innovative solutions and 250 with standard devices in each antiseptic group). No significant interaction was found between the two study interventions. Local infections occurred less frequently with chlorhexidine plus alcohol than with povidone iodine plus alcohol (0 [0%] of 496 patients vs six [1%] of 493 patients) and the same was observed for catheter colonisation (4/431 [1%] vs 70/415 [17%] catheters among the catheters cultured; adjusted subdistribution hazard ratio 0·08 [95% CI 0·02-0·18]). Median time between catheter insertion and catheter failure was longer in the innovation group compared with the standard group (50·4 [IQR 29·6-69·4] h vs 30·0 [16·6-52·6] h; p=0·0017). Minor skin reactions occurred in nine (2%) patients in the chlorhexidine plus alcohol group and seven (1%) patients in the povidone iodine plus alcohol group. INTERPRETATION For skin antisepsis, chlorhexidine plus alcohol provides greater protection of peripheral venous catheter-related infectious complications than does povidone iodine plus alcohol. Use of innovative devices extends the catheter complication-free dwell time. FUNDING Becton Dickinson. TRANSLATIONS For the Chinese, Portuguese, Spanish, Turkish and Russian translations of the abstract see Supplementary Materials section.",2021,Local infections occurred less frequently with chlorhexidine plus alcohol than with povidone iodine plus alcohol (0 [0%] of 496 patients vs six [1%] of 493 patients) and the same was observed for catheter colonisation (4/431 [1%] vs 70/415,"['group (250 with innovative solutions and 250 with standard devices in each antiseptic group', 'enrolled adults (age ≥18 years) visiting the emergency department at the Poitiers University Hospital, France, and requiring one peripheral venous catheter before admission to the medical wards', '1000 patients were recruited between Jan 7, and Sept 6, 2019, of whom 500 were assigned to the']","['chlorhexidine plus alcohol over 5% povidone iodine plus alcohol', 'Chlorhexidine plus alcohol versus povidone iodine plus alcohol, combined or not with innovative devices', 'secure web-based random-number generator to one of four treatment groups based on skin preparation and type of devices (innovative devices or standard devices; 2% chlorhexidine plus alcohol or 5% povidone iodine plus alcohol', 'chlorhexidine plus alcohol', 'povidone iodine plus alcohol']","['Median time between catheter insertion and catheter failure', 'incidence of infectious complications (local infection, catheter colonisation, or bloodstream infections) and time between catheter insertion and catheter failure (occlusion, dislodgment, infiltration, phlebitis, or infection', 'catheter colonisation', 'Minor skin reactions', 'catheter complication-free dwell time', 'Local infections']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0003205', 'cui_str': 'Antiseptic agent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0745442', 'cui_str': 'Venous catheter'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0237638', 'cui_str': 'Generator'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0455085', 'cui_str': 'Skin preparation'}, {'cui': 'C0449497', 'cui_str': 'Type of device'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0031542', 'cui_str': 'Phlebitis'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction'}, {'cui': 'C0274317', 'cui_str': 'Complication of catheter'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0429659', 'cui_str': 'Dwell time'}]",1000.0,0.123774,Local infections occurred less frequently with chlorhexidine plus alcohol than with povidone iodine plus alcohol (0 [0%] of 496 patients vs six [1%] of 493 patients) and the same was observed for catheter colonisation (4/431 [1%] vs 70/415,"[{'ForeName': 'Jérémy', 'Initials': 'J', 'LastName': 'Guenezan', 'Affiliation': 'Service des Urgences et SAMU 86 Centre 15, CHU de Poitiers, France; Université de Poitiers, UFR de Médecine-Pharmacie, Poitiers, France; INSERM U1070, Pharmacologie des Agents Anti-Infectieux, Poitiers, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Marjanovic', 'Affiliation': 'Service des Urgences et SAMU 86 Centre 15, CHU de Poitiers, France; Université de Poitiers, UFR de Médecine-Pharmacie, Poitiers, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Drugeon', 'Affiliation': 'Service des Urgences et SAMU 86 Centre 15, CHU de Poitiers, France.'}, {'ForeName': 'Rodérick O', 'Initials': 'RO', 'LastName': 'Neill', 'Affiliation': 'Service des Urgences et SAMU 86 Centre 15, CHU de Poitiers, France.'}, {'ForeName': 'Evelyne', 'Initials': 'E', 'LastName': 'Liuu', 'Affiliation': 'Service de Gériatrie, CHU de Poitiers, France.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Roblot', 'Affiliation': 'Université de Poitiers, UFR de Médecine-Pharmacie, Poitiers, France; INSERM U1070, Pharmacologie des Agents Anti-Infectieux, Poitiers, France; Service des Maladies Infectieuses et Tropicales, CHU de Poitiers, France.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Palazzo', 'Affiliation': 'Université de Poitiers, UFR de Médecine-Pharmacie, Poitiers, France; Service de Neurologie, CHU de Poitiers, France.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Bironneau', 'Affiliation': 'Service de Pneumologie, CHU de Poitiers, France.'}, {'ForeName': 'Frederique', 'Initials': 'F', 'LastName': 'Prevost', 'Affiliation': ""Service d'Hépato-Gastro Entérologie, CHU de Poitiers, France.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Paul', 'Affiliation': 'Plateforme Méthodologie-Data-Management, CHU de Poitiers, France.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Pichon', 'Affiliation': 'Université de Poitiers, UFR de Médecine-Pharmacie, Poitiers, France; INSERM U1070, Pharmacologie des Agents Anti-Infectieux, Poitiers, France; Département des agents infectieux, Laboratoire de Bactériologie-Hygiène, Chu de Poitiers, France.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Boisson', 'Affiliation': ""Université de Poitiers, UFR de Médecine-Pharmacie, Poitiers, France; INSERM U1070, Pharmacologie des Agents Anti-Infectieux, Poitiers, France; Service d'Anesthésie, Réanimation et Médecine Péri-Opératoire, CHU de Poitiers, France.""}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Frasca', 'Affiliation': ""Université de Poitiers, UFR de Médecine-Pharmacie, Poitiers, France; Service d'Anesthésie, Réanimation et Médecine Péri-Opératoire, CHU de Poitiers, France; INSERM U1246, Methods in Patients-centered outcomes and Health Research - SPHERE, Nantes, France.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Mimoz', 'Affiliation': 'Service des Urgences et SAMU 86 Centre 15, CHU de Poitiers, France; Université de Poitiers, UFR de Médecine-Pharmacie, Poitiers, France; INSERM U1070, Pharmacologie des Agents Anti-Infectieux, Poitiers, France. Electronic address: olivier.mimoz@chu-poitiers.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30738-6'] 2066,33544819,The dolutegravir/valproic acid drug-drug interaction is primarily based on protein displacement.,"OBJECTIVES The dolutegravir/valproic acid drug-drug interaction (DDI) is suggested to be caused by protein displacement. Here, we assess the underlying mechanism. METHODS Participants in a randomized controlled trial investigating valproic acid as an HIV latency reversing agent were recruited in a predefined pharmacokinetic substudy if they were on once-daily 50 mg dolutegravir-containing combination ART (cART) for >12 months with a plasma HIV-RNA <50 copies/mL (trial registration: ClinicalTrials.gov NCT03525730). Participants were randomized to receive 30 mg/kg/day valproic acid orally (divided into two equal doses) for 14 days or not. Total and unbound dolutegravir concentrations were measured on day 0 (before intake of valproic acid and 6 h after intake of valproic acid) and on days 1, 7, 14 and 42. Intra- and inter-subject dolutegravir concentrations and geometric means (GMs) were evaluated. RESULTS Six of 10 participants on dolutegravir were randomized to receive valproic acid. During 14 days of valproic acid treatment, the GM total dolutegravir concentration decreased sharply from 1.36 mg/L on day 0 to 0.85, 0.31 and 0.20 mg/L on days 0, 1, 7 and 14, respectively, while total dolutegravir concentrations in the controls remained comparable during the same period: 1.27-1.49 mg/L. We observed a parallel increase in unbound dolutegravir fractions ranging from 0.39% to 0.58% during valproic acid administration, compared with 0.25% to 0.28% without valproic acid. Unbound dolutegravir concentrations were above the established in vitro EC90 value for unbound dolutegravir in 85% of the tested samples. CONCLUSIONS This study confirms protein displacement as the main mechanism for this DDI, although additional mechanisms might be involved too. If dolutegravir is taken with food, this DDI is probably not clinically relevant.",2021,"Unbound dolutegravir concentrations were above the established in vitro EC90 value for unbound dolutegravir in 85% of the tested samples. ","['as an HIV latency reversing agent were recruited in a predefined pharmacokinetic substudy if they were on once-daily 50\u2009mg', 'Six of 10 participants on dolutegravir', 'Participants']","['valproic acid', 'dolutegravir-containing combination ART (cART', '30\u2009mg/kg/day valproic acid']","['unbound dolutegravir fractions', 'Intra- and inter-subject dolutegravir concentrations and geometric means (GMs', 'total dolutegravir concentrations', 'GM total dolutegravir concentration', 'Unbound dolutegravir concentrations', 'Total and unbound dolutegravir concentrations']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}]","[{'cui': 'C0042291', 'cui_str': 'valproic acid'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}]","[{'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.075199,"Unbound dolutegravir concentrations were above the established in vitro EC90 value for unbound dolutegravir in 85% of the tested samples. ","[{'ForeName': 'P D J', 'Initials': 'PDJ', 'LastName': 'Bollen', 'Affiliation': 'Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'H A B', 'Initials': 'HAB', 'LastName': 'Prins', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Colbers', 'Affiliation': 'Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Velthoven-Graafland', 'Affiliation': 'Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'B J A', 'Initials': 'BJA', 'LastName': 'Rijnders', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'T E M S', 'Initials': 'TEMS', 'LastName': 'de Vries-Sluijs', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'van Nood', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Nouwen', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Bax', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'de Mendonca Melo', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Verbon', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Burger', 'Affiliation': 'Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rokx', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, Erasmus Medical Center, Rotterdam, The Netherlands.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkab021'] 2067,33545575,"The effects of yoga on dyspnea, sleep and fatigue in chronic respiratory diseases.","PURPOSE This study was carried out to find out the effects of yoga applied to chronic respiratory disease patients on dyspnea, sleep quality and fatigue. MATERIAL AND METHOD The study was conducted between May and August 2020 as a randomized controlled study. 'Personal Information Form', 'Respiratory Functions Monitoring Form', 'COPD and Asthma Fatigue Scale (CAFS), ""Asthma and COPD Sleep Impact Scale (CASIS)"" and Modified Medical Research Council Dyspnea Scale (mMRC) were used in data collection. RESULTS When the post-test mean scores of the patients in the experimental and control group were compared, it was found that CAFS, CASIS and mMRC mean scores of the patients in the experimental group decreased positively compared to the patients in the control group and the difference between was found to be statistically significant (p < 0.05). CONCLUSION Yoga has been found to reduce the severity of dyspnea and fatigue and improve sleep quality in chronic respiratory diseases.",2021,"When the post-test mean scores of the patients in the experimental and control group were compared, it was found that CAFS, CASIS and mMRC mean scores of the patients in the experimental group decreased positively compared to the patients in the control group and the difference between was found to be statistically significant (p < 0.05). ",['chronic respiratory diseases'],[],"['severity of dyspnea and fatigue and improve sleep quality', 'dyspnea, sleep and fatigue', 'dyspnea, sleep quality and fatigue', 'CAFS, CASIS and mMRC mean scores', 'Personal Information Form\', \'Respiratory Functions Monitoring Form\', \'COPD and Asthma Fatigue Scale (CAFS), ""Asthma and COPD Sleep Impact Scale (CASIS)"" and Modified Medical Research Council Dyspnea Scale (mMRC']","[{'cui': 'C0264220', 'cui_str': 'Chronic disease of respiratory system'}]",[],"[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2983694', 'cui_str': 'Personally Identifiable Information'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]",,0.0106463,"When the post-test mean scores of the patients in the experimental and control group were compared, it was found that CAFS, CASIS and mMRC mean scores of the patients in the experimental group decreased positively compared to the patients in the control group and the difference between was found to be statistically significant (p < 0.05). ","[{'ForeName': 'Zülfünaz', 'Initials': 'Z', 'LastName': 'Özer', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Istanbul Sabahattin Zaim University, Istanbul, Turkey. Electronic address: zulfinazozer@gmail.com.'}, {'ForeName': 'Gülcan', 'Initials': 'G', 'LastName': 'Bahçecioğlu Turan', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Firat University, Elazıg, Turkey. Electronic address: glcnbah@hotmail.com.'}, {'ForeName': 'Meyreme', 'Initials': 'M', 'LastName': 'Aksoy', 'Affiliation': 'Department of Nursing, Faculty of Health Science Siirt University, Siirt, Turkey. Electronic address: meryeme_072@hotmail.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101306'] 2068,33545574,The effect of compound Da-Cheng-Qi Decoction on the treatment of malignant bowel obstruction with transnasal ileus tube.,"OBJECTIVE To study the effect of compound Da-Cheng-Qi Decoction (CDCQD) on the treatment of malignant bowel obstruction (MBO) with transnasal ileus tube (TIT). METHODS We observed 30 cases of MBO from July 2018 to August 2019. The patients were divided into the control group (n = 15) and the CDCQD group (n = 15) according to a random number table. All patients were inserted the TIT after admission. Twenty-four hours later, the CDCQD group began to take 100 ml CDCQD twice a day for 7 days. The control group took the plain boiled water instead. Other treatment was the same in the two groups. The waistline reduction, the release time of abdominal pain and distention, recovery of exhaust and defecation time, drainage volume of TIT were observed and compared between the two groups. RESULTS Three days after insertion of TIT, the abdominal plain film was re-examined in the two groups. Most of the patients' gas-liquid level disappeared and there was no significant difference between the two groups (P > 0.05). The effective rate of CDCQD group (86.7%) was significantly higher than that of control group (53.3%). The recovery time of exhaust and defecation in the CDCQD group was earlier than that in the control group (P < 0.05). The daily drainage volume of TIT in the CDCQD group was less than that in the control group, especially from the fourth day to the sixth day after insertion of TIT, with a significant difference (P < 0.05). CONCLUSION TIT is an effective treatment for patients with MBO. With the basis of TIT treatment, CDCQD therapy can improve the curative effect of MBO. It can promote intestinal exhaust and defecation and improves the curative effect of palliative treatment of MBO. It is an effective method to assist Tit in the treatment for MBO patients.",2021,Most of the patients' gas-liquid level disappeared and there was no significant difference between the two groups (P > 0.05).,"['30 cases of MBO from July 2018 to August 2019', 'malignant bowel obstruction (MBO) with transnasal ileus tube (TIT', 'patients with MBO', 'malignant bowel obstruction with transnasal ileus tube', 'MBO patients']","['compound Da-Cheng-Qi Decoction', 'plain boiled water instead', 'TIT', 'compound Da-Cheng-Qi Decoction (CDCQD', 'CDCQD']","['curative effect of MBO', 'recovery time of exhaust and defecation', 'effective rate', 'release time of abdominal pain and distention, recovery of exhaust and defecation time, drainage volume of TIT', 'daily drainage volume of TIT', 'gas-liquid level']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0021843', 'cui_str': 'Intestinal obstruction'}, {'cui': 'C0521131', 'cui_str': 'Transnasal approach'}, {'cui': 'C1258215', 'cui_str': 'Ileus'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C2935869', 'cui_str': 'Da-Cheng-Qi'}, {'cui': 'C0439892', 'cui_str': 'Boiled water'}, {'cui': 'C0521131', 'cui_str': 'Transnasal approach'}, {'cui': 'C1258215', 'cui_str': 'Ileus'}, {'cui': 'C0175730', 'cui_str': 'Tube'}]","[{'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0021843', 'cui_str': 'Intestinal obstruction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0521131', 'cui_str': 'Transnasal approach'}, {'cui': 'C1258215', 'cui_str': 'Ileus'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0162882,Most of the patients' gas-liquid level disappeared and there was no significant difference between the two groups (P > 0.05).,"[{'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Qi', 'Affiliation': 'Department of Nutrition, Tianjin Nankai Hospital, 300100, Tianjin, China. Electronic address: xiangqixiangqi@163.com.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Shimin', 'Affiliation': 'Department of Gastrointestinal Surgery, Tianjin Nankai Hospital, 300100, Tianjin, China.'}, {'ForeName': 'Wu', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Gastrointestinal Surgery, Tianjin Nankai Hospital, 300100, Tianjin, China.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101316'] 2069,33545542,"Effect of cacao polyphenol-rich chocolate on postprandial glycemia, insulin, and incretin secretion in healthy participants.","OBJECTIVES There is substantial interest in using dark chocolate to prevent postprandial hyperglycemia. We investigated the effects of cacao polyphenol-rich chocolate on postprandial glycemic and insulinemic responses and whether cacao polyphenol-rich chocolate increases glucagon-like peptide-1 (GLP-1) secretion. METHODS In a stratified, randomized, crossover study, 48 healthy participants ingested either water (W) or cacao polyphenol-rich chocolate plus water (C) 15 min before a 50 g oral glucose tolerance test (OGTT). Pre- and postprandial concentrations of blood glucose, insulin, free fatty acid, glucagon, and GLP-1 were evaluated. RESULTS Peak plasma glucose concentrations did not differ significantly between groups W and C; however, plasma glucose concentrations at 120 min in group C were significantly lower than those in group W (P < .01). Postprandial serum insulin and plasma GLP-1 concentrations and incremental serum insulin and plasma GLP-1 area under the curve (AUC) - 15-180 min for group C were significantly higher than those for group W (P < .05). When comparing the changes after the OGTT, the incremental plasma glucose AUC 0-180 min for group C was significantly lower than that for group W (P < .05), but the incremental serum insulin and plasma GLP-1 AUC 0-180 min did not differ significantly between groups W and C. CONCLUSIONS This study indicated that the intake of cacao polyphenol-rich chocolate before a 50 g OGTT could enhance early insulin and GLP-1 secretion in healthy participants, and illustrates the potential of cacao polyphenol-rich chocolate in managing postprandial glucose excursions.",2021,"Pre- and postprandial concentrations of blood glucose, insulin, free fatty acid, glucagon, and GLP-1 were evaluated. ","['48 healthy participants ingested either', 'healthy participants']","['cacao polyphenol-rich chocolate', 'water (W) or cacao polyphenol-rich chocolate plus water (C) 15 min before a 50 g oral glucose tolerance test (OGTT', 'GLP-1']","['postprandial glycemic and insulinemic responses', 'Postprandial serum insulin and plasma GLP-1 concentrations and incremental serum insulin and plasma GLP-1 area under the curve (AUC', 'Peak plasma glucose concentrations', 'postprandial hyperglycemia', 'Pre- and postprandial concentrations of blood glucose, insulin, free fatty acid, glucagon, and GLP-1', 'early insulin and GLP-1 secretion', 'postprandial glycemia, insulin, and incretin secretion', 'incremental plasma glucose AUC', 'incremental serum insulin and plasma', 'plasma glucose concentrations']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C1278023', 'cui_str': 'Plasma glucagon measurement'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}, {'cui': 'C1855520', 'cui_str': 'Postprandial Hyperglycemia'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C1562292', 'cui_str': 'Incretin'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",48.0,0.0188671,"Pre- and postprandial concentrations of blood glucose, insulin, free fatty acid, glucagon, and GLP-1 were evaluated. ","[{'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Kawakami', 'Affiliation': 'Laboratory of Clinical Nutrition and Management, Graduate Division of Nutritional and Environmental Sciences, and Graduate School of Integrated Pharmaceutical and Nutritional Sciences, The University of Shizuoka, Shizuoka, Japan. Electronic address: kawakami@u-shizuoka-ken.ac.jp.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Watanabe', 'Affiliation': 'Laboratory of Clinical Nutrition and Management, Graduate Division of Nutritional and Environmental Sciences, and Graduate School of Integrated Pharmaceutical and Nutritional Sciences, The University of Shizuoka, Shizuoka, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Mazuka', 'Affiliation': 'Laboratory of Clinical Nutrition and Management, Graduate Division of Nutritional and Environmental Sciences, and Graduate School of Integrated Pharmaceutical and Nutritional Sciences, The University of Shizuoka, Shizuoka, Japan.'}, {'ForeName': 'Natsuki', 'Initials': 'N', 'LastName': 'Yagi', 'Affiliation': 'Laboratory of Clinical Nutrition and Management, Graduate Division of Nutritional and Environmental Sciences, and Graduate School of Integrated Pharmaceutical and Nutritional Sciences, The University of Shizuoka, Shizuoka, Japan.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Sawazaki', 'Affiliation': 'Food Microbiology and Function Research Laboratories, R&D Division, Meiji Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Koganei', 'Affiliation': 'Food Microbiology and Function Research Laboratories, R&D Division, Meiji Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Midori', 'Initials': 'M', 'LastName': 'Natsume', 'Affiliation': 'Food Microbiology and Function Research Laboratories, R&D Division, Meiji Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Kiyonori', 'Initials': 'K', 'LastName': 'Kuriki', 'Affiliation': 'Laboratory of Public Health, Graduate Division of Nutritional and Environmental Sciences, and Graduate School of Integrated Pharmaceutical and Nutritional Sciences, The University of Shizuoka, Shizuoka, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Morimoto', 'Affiliation': 'Division of Molecular Medicine, Graduate Division of Pharmaceutical Sciences, and Graduate School of Integrated Pharmaceutical and Nutritional Sciences, The University of Shizuoka, Shizuoka, Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Asai', 'Affiliation': 'Asai Clinic, Shizuoka, Japan.'}, {'ForeName': 'Hidekazu', 'Initials': 'H', 'LastName': 'Arai', 'Affiliation': 'Laboratory of Clinical Nutrition and Management, Graduate Division of Nutritional and Environmental Sciences, and Graduate School of Integrated Pharmaceutical and Nutritional Sciences, The University of Shizuoka, Shizuoka, Japan.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.111128'] 2070,33546622,Effect of balanced crystalloids versus saline on urinary biomarkers of acute kidney injury in critically ill adults.,"BACKGROUND Recent trials have suggested use of balanced crystalloids may decrease the incidence of major adverse kidney events compared to saline in critically ill adults. The effect of crystalloid composition on biomarkers of early acute kidney injury remains unknown. METHODS From February 15 to July 15, 2016, we conducted an ancillary study to the Isotonic Solutions and Major Adverse Renal Events Trial (SMART) comparing the effect of balanced crystalloids versus saline on urinary levels of neutrophil gelatinase-associated lipocalin (NGAL) and kidney injury molecule-1 (KIM-1) among 261 consecutively-enrolled critically ill adults admitted from the emergency department to the medical ICU. After informed consent, we collected urine 36 ± 12 h after hospital admission and measured NGAL and KIM-1 levels using commercially available ELISAs. Levels of NGAL and KIM-1 at 36 ± 12 h were compared between patients assigned to balanced crystalloids versus saline using a Mann-Whitney U test. RESULTS The 131 patients (50.2%) assigned to the balanced crystalloid group and the 130 patients (49.8%) assigned to the saline group were similar at baseline. Urinary NGAL levels were significantly lower in the balanced crystalloid group (median, 39.4 ng/mg [IQR 9.9 to 133.2]) compared with the saline group (median, 64.4 ng/mg [IQR 27.6 to 339.9]) (P < 0.001). Urinary KIM-1 levels did not significantly differ between the balanced crystalloid group (median, 2.7 ng/mg [IQR 1.5 to 4.9]) and the saline group (median, 2.4 ng/mg [IQR 1.3 to 5.0]) (P = 0.36). CONCLUSIONS In this ancillary analysis of a clinical trial comparing balanced crystalloids to saline among critically ill adults, balanced crystalloids were associated with lower urinary concentrations of NGAL and similar urinary concentrations of KIM-1, compared with saline. These results suggest only a modest reduction in early biomarkers of acute kidney injury with use of balanced crystalloids compared with saline. TRIAL REGISTRATION ClinicalTrials.gov number: NCT02444988 . Date registered: May 15, 2015.",2021,"Urinary KIM-1 levels did not significantly differ between the balanced crystalloid group (median, 2.7 ng/mg [IQR 1.5 to 4.9]) and the saline group (median, 2.4 ng/mg [IQR 1.3 to 5.0])","['From February 15 to July 15, 2016', 'critically ill adults', '131 patients (50.2%) assigned to the', '261 consecutively-enrolled critically ill adults admitted from the emergency department to the medical ICU']","['balanced crystalloids versus saline', 'crystalloid composition', 'balanced crystalloid']","['Urinary NGAL levels', 'Urinary KIM-1 levels', 'urinary levels of neutrophil gelatinase-associated lipocalin (NGAL) and kidney injury molecule-1 (KIM-1']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]","[{'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0206528', 'cui_str': 'Gelatinase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1956074', 'cui_str': 'Lipocalin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1313407', 'cui_str': 'HAVCR1 protein, human'}, {'cui': 'C0243173', 'cui_str': 'urinary levels'}]",,0.284863,"Urinary KIM-1 levels did not significantly differ between the balanced crystalloid group (median, 2.7 ng/mg [IQR 1.5 to 4.9]) and the saline group (median, 2.4 ng/mg [IQR 1.3 to 5.0])","[{'ForeName': 'Blake E', 'Initials': 'BE', 'LastName': 'Funke', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Jackson', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, C-1216 MCN, 1161 21st Ave South, Nashville, TN, 37232, USA.'}, {'ForeName': 'Wesley H', 'Initials': 'WH', 'LastName': 'Self', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Collins', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Christina T', 'Initials': 'CT', 'LastName': 'Saunders', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Blume', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Wickersham', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, C-1216 MCN, 1161 21st Ave South, Nashville, TN, 37232, USA.'}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Brown', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, C-1216 MCN, 1161 21st Ave South, Nashville, TN, 37232, USA.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Casey', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, C-1216 MCN, 1161 21st Ave South, Nashville, TN, 37232, USA.'}, {'ForeName': 'Gordon R', 'Initials': 'GR', 'LastName': 'Bernard', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, C-1216 MCN, 1161 21st Ave South, Nashville, TN, 37232, USA.'}, {'ForeName': 'Todd W', 'Initials': 'TW', 'LastName': 'Rice', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, C-1216 MCN, 1161 21st Ave South, Nashville, TN, 37232, USA.'}, {'ForeName': 'Edward D', 'Initials': 'ED', 'LastName': 'Siew', 'Affiliation': 'Division of Nephrology and Hypertension, Vanderbilt Center for Kidney Disease (VCKD) and Integrated Program for AKI (VIP-AKI), Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Semler', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, C-1216 MCN, 1161 21st Ave South, Nashville, TN, 37232, USA. matthew.w.semler@vumc.org.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC nephrology,['10.1186/s12882-021-02236-x'] 2071,33554636,"Darolutamide and survival in nonmetastatic, castration-resistant prostate cancer: a patient perspective of the ARAMIS trial.","This is a summary of a publication about the ARAMIS (Androgen Receptor Antagonizing Agent for Metastasis-free Survival) trial, which was published in the New England Journal of Medicine in September 2020. The trial was in adult participants with nonmetastatic, castration-resistant prostate cancer (nmCRPC) who received a trial treatment called darolutamide (brand name Nubeqa®). Darolutamide is currently available as an oral treatment for adults with nmCRPC. The ARAMIS trial looked at darolutamide taken by mouth in 1509 participants from 36 countries with nmCRPC (prostate cancer that has not spread to other parts of the body and no longer responds adequately to initial hormone therapy). The trial showed that darolutamide in addition to hormone therapy increased the length of time that the trial participants were still alive for and lowered the risk of death by 31% compared with placebo (sugar pill) and hormone therapy. The participants who received darolutamide and hormone therapy also had longer time to worsening pain, needing chemotherapy, and having cancer-related bone fractures or symptoms related to cancer-related bone fractures compared with those who received placebo and hormone therapy during the trial. In general, the percentage of participants who experienced medical problems (referred to as adverse events) was similar between those who received darolutamide and those who received placebo, in addition to hormone therapy. This summary also includes insights and perspectives from a participant who was in the ARAMIS trial and from a prostate cancer patient advocate. To read the full Plain Language Summary of this article, click on the View Article button above and download the PDF. Clinical Trial Registration: NCT02200614 (ClinicalTrials.gov).",2021,"In general, the percentage of participants who experienced medical problems (referred to as adverse events) was similar between those who received darolutamide and those who received placebo, in addition to hormone therapy.","['adult participants with nonmetastatic, castration-resistant prostate cancer (nmCRPC) who received a trial treatment called darolutamide (brand name Nubeqa®', 'nonmetastatic, castration-resistant prostate cancer', 'adults with nmCRPC', '1509 participants from 36 countries with nmCRPC (prostate cancer that has not spread to other parts of the body and no longer responds adequately to initial hormone therapy']","['placebo and hormone therapy', 'darolutamide and hormone therapy', 'placebo']","['longer time to worsening pain, needing chemotherapy, and having cancer-related bone fractures or symptoms related to cancer-related bone fractures', 'risk of death', 'length of time', 'Darolutamide and survival']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C4547776', 'cui_str': 'darolutamide'}, {'cui': 'C5196199', 'cui_str': 'Nubeqa'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C4547776', 'cui_str': 'darolutamide'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C4547776', 'cui_str': 'darolutamide'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.201405,"In general, the percentage of participants who experienced medical problems (referred to as adverse events) was similar between those who received darolutamide and those who received placebo, in addition to hormone therapy.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Blue', 'Affiliation': 'Patient author.'}, {'ForeName': 'Joel T', 'Initials': 'JT', 'LastName': 'Nowak', 'Affiliation': 'Patient author.'}]","Future oncology (London, England)",['10.2217/fon-2020-1291'] 2072,33554614,Ablation Versus Drug Therapy for Atrial Fibrillation in Heart Failure: Results From the CABANA Trial.,"BACKGROUND In patients with heart failure and atrial fibrillation (AF), several clinical trials have reported improved outcomes, including freedom from AF recurrence, quality of life, and survival, with catheter ablation. This article describes the treatment-related outcomes of the AF patients with heart failure enrolled in the CABANA trial (Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation). METHODS The CABANA trial randomized 2204 patients with AF who were ≥65 years old or <65 years old with ≥1 risk factor for stroke at 126 sites to ablation with pulmonary vein isolation or drug therapy including rate or rhythm control drugs. Of these, 778 (35%) had New York Heart Association class >II at baseline and form the subject of this article. The CABANA trial's primary end point was a composite of death, disabling stroke, serious bleeding, or cardiac arrest. RESULTS Of the 778 patients with heart failure enrolled in CABANA, 378 were assigned to ablation and 400 to drug therapy. Ejection fraction at baseline was available for 571 patients (73.0%), and 9.3% of these had an ejection fraction <40%, whereas 11.7% had ejection fractions between 40% and 50%. In the intention-to-treat analysis, the ablation arm had a 36% relative reduction in the primary composite end point (hazard ratio, 0.64 [95% CI, 0.41-0.99]) and a 43% relative reduction in all-cause mortality (hazard ratio, 0.57 [95% CI, 0.33-0.96]) compared with drug therapy alone over a median follow-up of 48.5 months. AF recurrence was decreased with ablation (hazard ratio, 0.56 [95% CI, 0.42-0.74]). The adjusted mean difference for the AFEQT (Atrial Fibrillation Effect on Quality of Life) summary score averaged over the entire 60-month follow-up was 5.0 points, favoring the ablation arm (95% CI, 2.5-7.4 points), and the MAFSI (Mayo Atrial Fibrillation-Specific Symptom Inventory) frequency score difference was -2.0 points, favoring ablation (95% CI, -2.9 to -1.2). CONCLUSIONS In patients with AF enrolled in the CABANA trial who had clinically diagnosed stable heart failure at trial entry, catheter ablation produced clinically important improvements in survival, freedom from AF recurrence, and quality of life relative to drug therapy. These results, obtained in a cohort most of whom had preserved left ventricular function, require independent trial verification. Registration: URL: https://www.clinicaltrials.gov/ct2/show/NCT00911508; Unique identifier: NCT0091150.",2021,"AF recurrence was decreased with ablation (HR 0.56; 95% CI, 0.42 to 0.74).","['patients with heart failure (HF) and atrial fibrillation (AF', 'patients with atrial fibrillation enrolled in CABANA who had clinically diagnosed stable heart failure at trial entry', 'Atrial Fibrillation in Heart Failure', '778 HF patients enrolled in CABANA, 378 were assigned to ablation and 400 to drug therapy', 'AF patients with HF enrolled in the Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation (CABANA) trial', '2204 patients with AF who were ≥65 years old or <65 with ≥1 risk factor for stroke at 126 sites to ablation with pulmonary vein isolation or drug therapy including rate/rhythm control drugs']","['catheter ablation', 'Ablation Versus Drug Therapy']","['AF recurrence, quality of life (QOL), and survival, with catheter ablation', 'survival, freedom from AF recurrence, and quality of life relative to drug therapy', 'composite of death, disabling stroke, serious bleeding, or cardiac arrest', 'QOL (AFEQT) summary score', 'Mayo AF-specific Symptom Inventory (MAFSI) frequency score difference', 'Ejection fraction (EF', 'AF recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013168', 'cui_str': 'Drug Control'}]","[{'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]",2204.0,0.213114,"AF recurrence was decreased with ablation (HR 0.56; 95% CI, 0.42 to 0.74).","[{'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Packer', 'Affiliation': 'Mayo Clinic Hospital, St. Marys Campus, Rochester, MN (D.L.P., K.H.M., P.A.N.).'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Piccini', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (J.P.P., H.R.A.-K., A.P.S., T.D.B., K.L.L., D.B.M.).'}, {'ForeName': 'Kristi H', 'Initials': 'KH', 'LastName': 'Monahan', 'Affiliation': 'Mayo Clinic Hospital, St. Marys Campus, Rochester, MN (D.L.P., K.H.M., P.A.N.).'}, {'ForeName': 'Hussein R', 'Initials': 'HR', 'LastName': 'Al-Khalidi', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (J.P.P., H.R.A.-K., A.P.S., T.D.B., K.L.L., D.B.M.).'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Silverstein', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (J.P.P., H.R.A.-K., A.P.S., T.D.B., K.L.L., D.B.M.).'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Noseworthy', 'Affiliation': 'Mayo Clinic Hospital, St. Marys Campus, Rochester, MN (D.L.P., K.H.M., P.A.N.).'}, {'ForeName': 'Jeanne E', 'Initials': 'JE', 'LastName': 'Poole', 'Affiliation': 'University of Washington Medical Center, Seattle (J.E.P.).'}, {'ForeName': 'Tristram D', 'Initials': 'TD', 'LastName': 'Bahnson', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (J.P.P., H.R.A.-K., A.P.S., T.D.B., K.L.L., D.B.M.).'}, {'ForeName': 'Kerry L', 'Initials': 'KL', 'LastName': 'Lee', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (J.P.P., H.R.A.-K., A.P.S., T.D.B., K.L.L., D.B.M.).'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (J.P.P., H.R.A.-K., A.P.S., T.D.B., K.L.L., D.B.M.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.120.050991'] 2073,33524994,"Adenoma detection by Endocuff-assisted versus standard colonoscopy in an organized screening program: the ""ItaVision"" randomized controlled trial.","BACKGROUND The Endocuff Vision device (Arc Medical Design Ltd., Leeds, UK) has been shown to increase mucosal exposure, and consequently adenoma detection rate (ADR), during colonoscopy. This nationwide multicenter study assessed possible benefits and harms of using Endocuff Vision in a fecal immunochemical test (FIT)-based screening program. METHODS Patients undergoing colonoscopy after a FIT-positive test were randomized 1:1 to undergo Endocuff-assisted colonoscopy or standard colonoscopy, stratified by sex, age, and screening history. Primary outcome was ADR. Secondary outcomes were ADR stratified by endoscopists' ADR, advanced ADR (AADR), adenomas per colonoscopy (APC), withdrawal time, and adverse events. RESULTS 1866 patients were enrolled across 13 centers. After exclusions, 1813 (mean age 60.1 years; male 53.8 %) were randomized (908 Endocuff Vision, 905 standard colonoscopy). ADR was significantly higher in the Endocuff Vision arm (47.8 % vs. 40.8 %; relative risk [RR] 1.17, 95 % confidence interval [CI] 1.06-1.30), with no differences between arms regarding size or morphology. When stratifying for endoscopists' ADR, only low detectors (ADR < 33.3 %) showed a statistically significant ADR increase (Endocuff Vision 41.1 % [95 %CI 35.7-46.7] vs. standard colonoscopy 26.0 % [95 %CI 21.3-31.4]). AADR (24.8 % vs. 20.5 %, RR 1.21, 95 %CI 1.02-1.43) and APC (0.94 vs. 0.77; P  = 0.001) were higher in the Endocuff Vision arm. Withdrawal time and adverse events were similar between arms. CONCLUSION Endocuff Vision increased ADR in a FIT-based screening program by improvingexamination of the whole colonic mucosa. Utility was highest among endoscopists with a low ADR.",2021,"AADR (24.8% vs 20.5%, RR 1.21; 95%CI 1.02-1.43) and APC (0.94 vs. 0.77, p=0.001) were higher in the EV arm.","['1,864 patients were enrolled in 13 centres', 'Design Patients undergoing colonoscopy after a FIT+ test', 'After exclusions, 1,813 (males: 53.7%; mean age: 60.1 years) were randomised, 908 in the EV arm and 905 in the control']","['Endocuff-assisted versus standard colonoscopy', 'colonoscopy with EV or standard colonoscopy']","['APC', 'AADR', ""ADR stratified by endoscopists' ADR, advanced ADR (AADR), adenoma per colonoscopy (APC), withdrawal time (WT), and adverse events (AE"", 'ADR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1321660', 'cui_str': 'Fosamprenavir calcium'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0003315', 'cui_str': 'Immunologic Accessory Cells'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1864.0,0.205146,"AADR (24.8% vs 20.5%, RR 1.21; 95%CI 1.02-1.43) and APC (0.94 vs. 0.77, p=0.001) were higher in the EV arm.","[{'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Zorzi', 'Affiliation': 'Veneto Tumor Registry, Azienda Zero, Padova, Italy.'}, {'ForeName': 'Cesare', 'Initials': 'C', 'LastName': 'Hassan', 'Affiliation': 'Gastroenterology Unit, Nuovo Regina Margherita Hospital, Rome, Italy.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Battagello', 'Affiliation': 'Veneto Tumor Registry, Azienda Zero, Padova, Italy.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Antonelli', 'Affiliation': 'Gastroenterology Unit, Nuovo Regina Margherita Hospital, Rome, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Pantalena', 'Affiliation': 'Gastroenterology Unit, Cazzavillan Hospital, ULSS 8 Berica, Arzignano, Italy.'}, {'ForeName': 'Gianmarco', 'Initials': 'G', 'LastName': 'Bulighin', 'Affiliation': 'Gastroenterology and Digestive Endoscopy Unit, Fracastoro Hospital, ULSS 9 Scaligera, San Bonifacio, Italy.'}, {'ForeName': 'Saverio', 'Initials': 'S', 'LastName': 'Alicante', 'Affiliation': 'Gastroenterology Department, ASST-Crema, Maggiore Hospital, Crema, Italy.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Meggiato', 'Affiliation': 'Department of Gastroenterology, Rovigo General Hospital, ULSS 5 Polesana, Rovigo, Italy.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Rosa-Rizzotto', 'Affiliation': 'Gastroenterology Unit, St. Anthony Hospital, Azienda Ospedale-Università, Padua, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Iacopini', 'Affiliation': 'Gastroenterology and Digestive Endoscopy Unit, Ospedale dei Castelli (N.O.C.), ASL Roma 6, Ariccia, Rome, Italy.'}, {'ForeName': 'Carmelo', 'Initials': 'C', 'LastName': 'Luigiano', 'Affiliation': 'Unit of Digestive Endoscopy, ASST Santi Paolo e Carlo, Milan, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Monica', 'Affiliation': 'Gastroenterology and Digestive Endoscopy Unit, Cattinara University Hospital, Trieste, Italy.'}, {'ForeName': 'Arrigo', 'Initials': 'A', 'LastName': 'Arrigoni', 'Affiliation': 'Gastroenterology Unit, University Hospital Città della Salute e della Scienza, Turin, Italy.'}, {'ForeName': 'Bastianello', 'Initials': 'B', 'LastName': 'Germanà', 'Affiliation': 'Gastroenterology and Digestive Endoscopy Unit, San Martino Hospital, ULSS 1 Dolomiti, Belluno, Italy.'}, {'ForeName': 'Flavio', 'Initials': 'F', 'LastName': 'Valiante', 'Affiliation': 'Gastroenterology and Digestive Endoscopy Unit, Santa Maria del Prato Hospital, ULSS 1 Dolomiti, Feltre, Italy.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Mallardi', 'Affiliation': 'Screening Unit, Institute for Cancer Research, Prevention and Oncological Network (ISPRO), Florence, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Senore', 'Affiliation': 'Epidemiology and Screening Unit - CPO, University Hospital Città della Salute e della Scienza, Turin, Italy.'}, {'ForeName': 'Grazia', 'Initials': 'G', 'LastName': 'Grazzini', 'Affiliation': 'Screening Unit, Institute for Cancer Research, Prevention and Oncological Network (ISPRO), Florence, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Mantellini', 'Affiliation': 'Screening Unit, Institute for Cancer Research, Prevention and Oncological Network (ISPRO), Florence, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Endoscopy,['10.1055/a-1379-6868'] 2074,33529593,Real-Time Photographic- and Fluorescein Angiographic-Guided Management of Diabetic Retinopathy: Randomized PRIME Trial Outcomes.,"PURPOSE To assess the safety and efficacy of as-needed (PRN) intravitreal aflibercept injections (IAI) in managing diabetic retinopathy (DR) guided by the real-time DR severity scale (DRSS) level or panretinal leakage index (PLI) assessment among eyes without diabetic macular edema (DME). DESIGN Prospective, randomized phase 2 trial (PRIME). METHODS A total of 40 eyes with nonproliferative (NPDR) or proliferative DR (PDR) received monthly IAIs until a DRSS improvement of ≥2 steps was achieved and eyes were randomized (1:1) to DRSS-guided or PLI-guided management strategies graded by a central reading center. Main outcome measurements included safety and changes in DRSS and PLI. RESULTS Through week 52, 95% of eyes achieved a DRSS improvement of ≥2 steps. Following DRSS improvement, 97% of eyes required at least 1 PRN IAI. In eyes requiring PRN IAI and completing week 52, 100% and 59% experienced DRSS worsening (P = .01) in the DRSS- and PLI-guided arms, respectively. Through week 52, mean PLI decreased 18.2% (P = .49) and 54.6% (P <.0001), respectively, in the DRSS- and PLI-guided arms. NPDR versus PDR eyes at baseline achieved a DRSS improvement of ≥2 steps after a mean 4.9 and 3.6 IAIs (P = .03). Two eyes developed a PDR event at week 52 following 5 months of quiescence. CONCLUSIONS The randomized PRIME study analyzed 2 imaging-based biomarkers to guide PRN management with IAI of DR without DME: DRSS level and PLI. Within the context of this study with limitations, most patients required IAI re-treatment every 3-4 months, and deterioration of PLI appeared to precede DRSS level worsening. Finally, these findings reaffirm the fact that close clinical follow-up is important even among eyes that achieve substantial DRSS improvements with apparently quiescent disease.",2021,"Through W52, mean PLI decreased 18.2% (p=0.49) and 54.6% (p<0.0001) in the DRSS- and PLI-guided arms.","['eyes without diabetic macular edema (DME', 'Forty eyes with non-proliferative (NPDR) or proliferative DR (PDR) received monthly IAI until a ≥2-step DRSS improvement was achieved and were randomized (1:1) to', 'Diabetic Retinopathy']","['needed (PRN) intravitreal aflibercept injections (IAI', 'DRSS-guided or PLI-guided management strategies, graded by a central reading center']","['mean PLI', 'safety and efficacy', 'safety as well as changes in DRSS and PLI', 'DRSS worsening', 'PDR event', 'real-time DR severity scale (DRSS) level or panretinal leakage index (PLI) assessment', '≥2-step DRSS improvement']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0334094', 'cui_str': 'Proliferation'}, {'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}]","[{'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442132', 'cui_str': 'Panretinal'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0442132', 'cui_str': 'Panretinal'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0334094', 'cui_str': 'Proliferation'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}]",40.0,0.0376806,"Through W52, mean PLI decreased 18.2% (p=0.49) and 54.6% (p<0.0001) in the DRSS- and PLI-guided arms.","[{'ForeName': 'Hannah J', 'Initials': 'HJ', 'LastName': 'Yu', 'Affiliation': 'Retina Consultants of Texas, Houston, Texas, USA.'}, {'ForeName': 'Justis P', 'Initials': 'JP', 'LastName': 'Ehlers', 'Affiliation': 'Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA. Electronic address: ehlersj@ccf.org.'}, {'ForeName': 'Duriye Damla', 'Initials': 'DD', 'LastName': 'Sevgi', 'Affiliation': 'Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Hach', 'Affiliation': 'Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': ""O'Connell"", 'Affiliation': 'Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Jamie L', 'Initials': 'JL', 'LastName': 'Reese', 'Affiliation': 'Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Sunil K', 'Initials': 'SK', 'LastName': 'Srivastava', 'Affiliation': 'Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Texas, Houston, Texas, USA; Blanton Eye Institute (CCW), Houston Methodist Hospital, Houston, Texas, USA. Electronic address: charleswykoff@gmail.com.'}]",American journal of ophthalmology,['10.1016/j.ajo.2021.01.024'] 2075,33529588,"Early Onset and Broad Activity of Reproxalap in a Randomized, Double-Masked, Vehicle-Controlled Phase 2b Trial in Dry Eye Disease.","PURPOSE To assess the activity of reproxalap, a novel reactive aldehyde species (RASP) inhibitor, relative to vehicle in patients with dry eye disease (DED) DESIGN: Randomized, double-masked, vehicle-controlled Phase 2b trial METHODS: Three hundred patients with DED were randomly assigned 1:1:1 at multiple US sites to receive 0.1% topical ocular reproxalap, 0.25% topical ocular reproxalap, or vehicle. Eyes were treated bilaterally 4 times daily for 12 weeks. Standard signs and symptoms of DED were assessed at baseline and at Weeks 2, 4, 8, and 12. RESULTS A dose response was observed for signs and symptoms of DED. Relative to vehicle over 12 weeks of therapy, the largest symptomatic improvement was observed in ocular dryness (0.25%, P = .047), and the largest objective sign improvement was observed in nasal region fluorescein staining (0.25%, P = .030). A greater proportion of patients receiving 0.25% reproxalap vs. vehicle reported dryness scores of 0 (P = .012). Improvements in combined DED symptoms were evident by the first post-baseline visit (Week 2, 0.25%, P < .0001) in patients with baseline scores greater than or equal to median values. No significant changes in safety measures were observed. CONCLUSION The novel RASP inhibitor reproxalap demonstrated rapid, broad, and clinically relevant symptomatic control, in conjunction with statistically significant improvement over vehicle in signs of DED as demonstrated by fluorescein staining, in DED patients over 12 weeks of therapy. The results represent the first vehicle-controlled evidence for the therapeutic potential of RASP inhibition to mitigate the signs and symptoms of dry eye disease.",2021,"Relative to vehicle over 12 weeks of therapy, the largest symptomatic improvement was observed in ocular dryness (0.25% P = .047), and the largest objective sign improvement was observed in nasal region fluorescein staining (0.25% P = .030).","['Three hundred patients with DED', 'patients with dry eye disease (DED']","['topical ocular reproxalap, 0.25% topical ocular reproxalap, or vehicle']","['ocular dryness', 'safety measures', 'dryness scores', 'nasal region fluorescein staining', 'Standard signs and symptoms of DED', 'largest objective sign improvement']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0446452', 'cui_str': 'Region of nose'}, {'cui': 'C0060520', 'cui_str': 'Fluorescein'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0220912', 'cui_str': 'signs'}]",300.0,0.248719,"Relative to vehicle over 12 weeks of therapy, the largest symptomatic improvement was observed in ocular dryness (0.25% P = .047), and the largest objective sign improvement was observed in nasal region fluorescein staining (0.25% P = .030).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Clark', 'Affiliation': 'From Aldeyra Therapeutics (D.C., T.C.B.), Lexington, Massachusetts.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Tauber', 'Affiliation': 'Tauber Eye Center (J.T.), Kansas City, Missouri.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sheppard', 'Affiliation': 'Virginia Eye Consultants (J.S.), Norfolk, Virginia, USA.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Brady', 'Affiliation': 'From Aldeyra Therapeutics (D.C., T.C.B.), Lexington, Massachusetts. Electronic address: tbrady@aldeyra.com.'}]",American journal of ophthalmology,['10.1016/j.ajo.2021.01.011'] 2076,33533037,Cardiac device implant wound closure with a novel low-density suture spacing single layer method.,"BACKGROUND To establish a novel time-saving and safe suture method for cardiac implantable electronic device (CIED) implantation. METHODS From January 2017 to April 2020, a total of 1317 patients scheduled for CIED procedure were consecutively enrolled in this study. Wound closure of all patients were prospectively assigned either to low-density suture spacing single layer suture group (single-layer group) or traditional two layer suture group (two-layer group). The effects of two closure methods on wound healing and pocket related complications were compared. RESULTS There were no significant differences in age, gender, BMI, comorbid diseases (diabetes, hypertension, coronary heart disease, and chronic kidney disease), and antiplatelet or anticoagulant drug use between the two groups. The number of suture stitches in the single-layer group was significantly less than that in the two-layer group [3.03(3-4) vs. 7.17(7-10), p < .001], the suture time in the single-layer group was significantly shorter than that in the two-layer group [190.57(167-256) s vs. 493.36(452-655) s, p < .001], and the incidence of clinically significant hematoma in the single-layer group was comparable to that in the two-layer group (0.7% vs. 0.3%, p = .742). Additionally, there were no significant differences in the incidence of pocket infection, dehiscence and keloid between the two groups. CONCLUSION Novel single-layer suture with low-density suture spacing is feasible and associated with a low incidence of wound dehiscence or infection for CIED implantation.",2021,"Additionally, there were no significant differences in the incidence of pocket infection, dehiscence and keloid between the two groups. ","['From January 2017 to April 2020, a total of 1317 patients scheduled for CIED procedure were consecutively enrolled in this study']","['Cardiac device implant wound closure with a novel low-density suture spacing single layer method', 'low-density suture spacing single layer suture group (single-layer group) or traditional two layer suture group']","['incidence of clinically significant hematoma', 'wound healing and pocket related complications', 'suture time', 'incidence of pocket infection, dehiscence and keloid', 'number of suture stitches', 'age, gender, BMI, comorbid diseases (diabetes, hypertension, coronary heart disease, and chronic kidney disease']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C1320542', 'cui_str': 'Procedure device'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence'}, {'cui': 'C0022548', 'cui_str': 'Keloid'}, {'cui': 'C0457280', 'cui_str': 'Number of sutures'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]",1317.0,0.0349731,"Additionally, there were no significant differences in the incidence of pocket infection, dehiscence and keloid between the two groups. ","[{'ForeName': 'Tianbao', 'Initials': 'T', 'LastName': 'Yao', 'Affiliation': 'Department of Cardiology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Nie', 'Affiliation': 'Department of Cardiology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Jiateng', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Cardiology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'Department of Cardiology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Minhua', 'Initials': 'M', 'LastName': 'Zang', 'Affiliation': 'Department of Cardiology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Shenghen', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Jialiang', 'Initials': 'J', 'LastName': 'Mao', 'Affiliation': 'Department of Cardiology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Pu', 'Affiliation': 'Department of Cardiology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}]",Pacing and clinical electrophysiology : PACE,['10.1111/pace.14184'] 2077,33532995,The immunomodulatory effect of ketamine in colorectal cancer surgery: a randomized-controlled trial.,"PURPOSE Ketamine's inhibitory action on the N-methyl-D-aspartate receptor and anti-inflammatory effects may provide beneficial immunomodulation in cancer surgery. We investigated the effect of subanesthetic-dose ketamine as an adjunct to desflurane anesthesia on natural killer (NK) cell activity and inflammation in patients undergoing colorectal cancer surgery. METHODS A total of 100 patients were randomly assigned to a control or ketamine group. The ketamine group received a bolus of 0.25 mg·kg -1 ketamine five minutes before the start of surgery, followed by an infusion 0.05 mg·kg -1 ·hr -1 until the end of surgery; the control group received a similar amount of normal saline. We measured NK cell activity and proinflammatory cytokines (interleukin-6 [IL-6] and tumour necrosis factor-α [TNF-α]) before surgery and one, 24, and 48 hr after surgery. C-reactive protein (CRP) was measured before surgery and one, three, and five days after surgery. Carcinoembryonic antigen and cancer recurrence/metastasis were assessed two years after surgery. RESULTS The NK cell activity was significantly decreased after surgery in both groups, but the change was not different between groups in the linear mixed model analysis (P = 0.47). Changes in IL-6, TNF-α, CRP, and carcinoembryonic antigen levels were not different between groups (P = 0.27, 0.69, 0.99, and 0.97, respectively). Cancer recurrence within 2 years after surgery was similar between groups (10% vs 8%, P = 0.62). CONCLUSIONS Intraoperative low-dose ketamine administration did not convey any favourable impacts on overall postoperative NK cell activity, inflammatory responses, and prognosis in colorectal cancer surgery patients. TRIAL REGISTRATION www.clinicaltrial.gov (NCT03273231); registered 6 September 2017.",2021,"Changes in IL-6, TNF-α, CRP, and carcinoembryonic antigen levels were not different between groups (P = 0.27, 0.69, 0.99, and 0.97, respectively).","['colorectal cancer surgery patients', 'A total of 100 patients', 'patients undergoing colorectal cancer surgery', 'cancer surgery', 'colorectal cancer surgery']","['ketamine', 'Ketamine', 'control group received a similar amount of normal saline', 'desflurane anesthesia', 'bolus of 0.25 mg·kg -1 ketamine', 'subanesthetic-dose ketamine', 'control or ketamine']","['Cancer recurrence', 'C-reactive protein (CRP', 'NK cell activity and proinflammatory cytokines (interleukin-6 [IL-6] and tumour necrosis factor-α [TNF-α', 'overall postoperative NK cell activity, inflammatory responses, and prognosis', 'natural killer (NK) cell activity and inflammation', 'IL-6, TNF-α, CRP, and carcinoembryonic antigen levels', 'Carcinoembryonic antigen and cancer recurrence/metastasis', 'NK cell activity']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0022688', 'cui_str': 'NK-cell'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0007082', 'cui_str': 'Carcinoembryonic antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",100.0,0.251179,"Changes in IL-6, TNF-α, CRP, and carcinoembryonic antigen levels were not different between groups (P = 0.27, 0.69, 0.99, and 0.97, respectively).","[{'ForeName': 'Jin Sun', 'Initials': 'JS', 'LastName': 'Cho', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Republic of Korea.'}, {'ForeName': 'Na Young', 'Initials': 'NY', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Republic of Korea.'}, {'ForeName': 'Jae-Kwang', 'Initials': 'JK', 'LastName': 'Shim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Republic of Korea.'}, {'ForeName': 'Ji Hae', 'Initials': 'JH', 'LastName': 'Jun', 'Affiliation': 'Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sugeun', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Republic of Korea.'}, {'ForeName': 'Young-Lan', 'Initials': 'YL', 'LastName': 'Kwak', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Republic of Korea. ylkwak@yuhs.ac.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-021-01925-3'] 2078,33532993,Programmed intermittent epidural bolus for labour analgesia during first stage of labour: a sequential allocation trial to determine the effective interval time between boluses of a fixed volume of 2.5 mL of bupivacaine 0.25% plus fentanyl 8 µg·mL -1 .,"PURPOSE We studied the programmed intermittent epidural bolus (PIEB) time interval between boluses of 2.5 mL of bupivacaine 0.25% with fentanyl 8 µg·mL -1 to produce effective analgesia in 90% of women (EI90) during the first stage of labour. METHODS In a double-blind sequential allocation trial using a biased coin up-and-down design to determine the EI90, the PIEB boluses of 2.5 mL of 0.25% bupivacaine plus fentanyl 8 µg·mL -1 were delivered at varying intervals-60, 50, 40, and 30 min. The primary outcome was the adequate response of the patient to the PIEB regimen, defined as no use of supplemental analgesia for six hours or until the first stage of labour was completed, whichever came first. The secondary outcomes were the upper sensory block level to ice, motor block and hypotension. The isotonic regression with extrapolation approach was used to estimate the EI90. RESULTS In the 20 women studied, the estimated EI90 was 20 (95% CI, 5.9 to 28.8) min. For the secondary outcomes, we classified women into those assigned to 30 min (16 women) and those assigned to more than 30 min (four women). The median upper sensory block for women in the 30-min group and more than 30 min were T6 (or T5) and T7, respectively. No participants experienced motor block. Hypotension occurred in one patient in the 30-min group. CONCLUSION The estimated EI90 for boluses of 2.5 mL of bupivacaine 0.25% with fentanyl 8 µg·mL -1 was 20 (95% CI, 5.9 to 28.8) min. These results suggest that there is no advantage in using this regimen compared with those reported in the literature using the same dose of bupivacaine in concentrations of 0.0625% and 0.125%. TRIAL REGISTRATION www.clinicaltrials.gov (NCT03735771); registered 7 November 2018.",2021,"The estimated EI90 for boluses of 2.5 mL of bupivacaine 0.25% with fentanyl 8 µg·mL -1 was 20 (95% CI, 5.9 to 28.8) min.","['labour analgesia during first stage of labour', '90% of women (EI90) during the first stage of labour']","['bupivacaine', 'bupivacaine plus fentanyl']","['effective interval time', 'Hypotension', 'motor block', 'adequate response of the patient to the PIEB regimen, defined as no use of supplemental analgesia for six hours or until the first stage of labour', 'median upper sensory block', 'upper sensory block level to ice, motor block and hypotension']","[{'cui': 'C1301740', 'cui_str': 'Analgesia in labor'}, {'cui': 'C0022871', 'cui_str': 'First stage of labor'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0022871', 'cui_str': 'First stage of labor'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020746', 'cui_str': 'Ice'}]",,0.286925,"The estimated EI90 for boluses of 2.5 mL of bupivacaine 0.25% with fentanyl 8 µg·mL -1 was 20 (95% CI, 5.9 to 28.8) min.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Shatalin', 'Affiliation': 'Department of Anesthesia and Pain Management, Mount Sinai Hospital, University of Toronto, 600 University Avenue, Room 7-405, Toronto, ON, M5G 1X5, Canada. danielsmail@gmail.com.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Arzola', 'Affiliation': 'Department of Anesthesia and Pain Management, Mount Sinai Hospital, University of Toronto, 600 University Avenue, Room 7-405, Toronto, ON, M5G 1X5, Canada.'}, {'ForeName': 'Kristi', 'Initials': 'K', 'LastName': 'Downey', 'Affiliation': 'Department of Anesthesia and Pain Management, Mount Sinai Hospital, University of Toronto, 600 University Avenue, Room 7-405, Toronto, ON, M5G 1X5, Canada.'}, {'ForeName': 'Xiang Y', 'Initials': 'XY', 'LastName': 'Ye', 'Affiliation': 'Department of Pediatrics, Micare Research Centre, Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Jose C A', 'Initials': 'JCA', 'LastName': 'Carvalho', 'Affiliation': 'Department of Anesthesia and Pain Management, Mount Sinai Hospital, University of Toronto, 600 University Avenue, Room 7-405, Toronto, ON, M5G 1X5, Canada.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-021-01922-6'] 2079,33537871,Efficacy of Agomelatine 25-50 mg for the Treatment of Anxious Symptoms and Functional Impairment in Generalized Anxiety Disorder: A Meta-Analysis of Three Placebo-Controlled Studies.,"INTRODUCTION The purpose of this study is to investigate the effects of agomelatine on anxious symptoms and functional impairment in a pooled dataset from randomized placebo-controlled trials for generalized anxiety disorder (GAD). METHODS Data from three randomized, placebo-controlled trials that evaluated the efficacy of agomelatine 25-50 mg were pooled. The short-term (12 weeks) efficacy of agomelatine was assessed in regards to (1) anxious symptoms using the Hamilton Anxiety Scale (HAM-A), and (2) functional impairment using the Sheehan Disability Scale (SDS). Meta-analysis using a random effect model was used to assess differences between groups. Remission and response rates for the HAM-A and SDS were calculated, and analyses were repeated in participants with more severe anxiety symptoms. RESULTS In total, 669 patients (340 on agomelatine; 329 on placebo) were included in the analyses. Compared to placebo, the agomelatine group had a significant reduction in HAM-A total score at week 12 (between group difference: 6.30 ± 2.51, p = 0.012). Significant effects were also found for symptom response on the HAM-A (67.1% of patients on agomelatine vs. 32.5% on placebo) and symptom remission (38.8% of patients on agomelatine vs. 17.3% on placebo). Compared to placebo, there was a significant difference in favour of the agomelatine group at week 12 on the SDS total score (5.11 ± 1.81, p = 0.005). Significant effects were also found for functional response on the SDS (79.1% of patients on agomelatine vs. 43.2% of placebo) and functional remission (55.2% of patients on agomelatine vs. 25.4% on placebo). All findings for anxious symptoms and functional impairment were confirmed in the subset of more severely anxious patients. Agomelatine was well tolerated by patients. CONCLUSION This meta-analysis confirms that agomelatine reduces anxiety symptoms and improves the global functioning of GAD patients.",2021,"Compared to placebo, there was a significant difference in favour of the agomelatine group at week 12 on the SDS total score (5.11 ± 1.81, p = 0.005).","['generalized anxiety disorder (GAD', '669 patients (340 on agomelatine; 329 on', 'Anxious Symptoms and Functional Impairment in Generalized Anxiety Disorder']","['agomelatine', 'Agomelatine', 'placebo']","['regards to (1) anxious symptoms using the Hamilton Anxiety Scale (HAM-A), and (2) functional impairment using the Sheehan Disability Scale (SDS', 'anxiety symptoms', 'severe anxiety symptoms', 'SDS total score', 'HAM-A total score', 'functional response on the SDS', 'Remission and response rates', 'symptom remission', 'symptom response on the HAM-A', 'functional remission', 'anxious symptoms and functional impairment']","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0971637', 'cui_str': 'agomelatine'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]","[{'cui': 'C0971637', 'cui_str': 'agomelatine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C4720840', 'cui_str': 'Sheehan disability scale'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0231403', 'cui_str': 'Severe anxiety (panic)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",669.0,0.200147,"Compared to placebo, there was a significant difference in favour of the agomelatine group at week 12 on the SDS total score (5.11 ± 1.81, p = 0.005).","[{'ForeName': 'Dan J', 'Initials': 'DJ', 'LastName': 'Stein', 'Affiliation': 'SAMRC Unit on Risk and Resilience in Mental Disorders, Department of Psychiatry and Neuroscience Institute, University of Cape Town and Groote Schuur Hospital, Cape Town, South Africa. dan.stein@uct.ac.za.'}, {'ForeName': 'Jon-Paul', 'Initials': 'JP', 'LastName': 'Khoo', 'Affiliation': 'Toowong Specialist Clinic, Toowong, Brisbane, Australia.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Picarel-Blanchot', 'Affiliation': 'Servier Affaires Médicales, Suresnes Cedex, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Olivier', 'Affiliation': 'Institut de Recherches Internationales Servier (IRIS), Suresnes Cedex, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Van Ameringen', 'Affiliation': 'Department of Psychiatry and Behavioural Neuroscience, McMaster University-MacAnxiety Research Centre, Hamilton, ON, Canada.'}]",Advances in therapy,['10.1007/s12325-020-01583-9'] 2080,33539946,Second-line nivolumab in relapsed small-cell lung cancer: CheckMate 331 ☆ .,"BACKGROUND Patients with relapsed small-cell lung cancer (SCLC) have few treatment options and dismal survival. Phase I/II data show activity of nivolumab in previously treated SCLC. PATIENTS AND METHODS CheckMate 331 is a randomized, open-label, phase III trial of nivolumab versus standard chemotherapy in relapsed SCLC. Patients with relapse after first-line, platinum-based chemotherapy were randomized 1 : 1 to nivolumab 240 mg every 2 weeks or chemotherapy (topotecan or amrubicin) until progression or unacceptable toxicity. Primary endpoint was overall survival (OS). RESULTS Overall, 284 patients were randomized to nivolumab and 285 to chemotherapy. Minimum follow-up was 15.8 months. No significant improvement in OS was seen with nivolumab versus chemotherapy [median OS, 7.5 versus 8.4 months; hazard ratio (HR), 0.86; 95% confidence interval (CI), 0.72-1.04; P = 0.11]. A survival benefit with nivolumab was suggested in patients with baseline lactate dehydrogenase ≤ upper limit of normal and in those without baseline liver metastases. OS (nivolumab versus chemotherapy) was similar in patients with programmed death-ligand 1 combined positive score ≥1% versus <1%. Median progression-free survival was 1.4 versus 3.8 months (HR, 1.41; 95% CI, 1.18-1.69). Objective response rate was 13.7% versus 16.5% (odds ratio, 0.80; 95% CI, 0.50-1.27); median duration of response was 8.3 versus 4.5 months. Rates of grade 3 or 4 treatment-related adverse events were 13.8% versus 73.2%. CONCLUSION Nivolumab did not improve survival versus chemotherapy in relapsed SCLC. No new safety signals were seen. In exploratory analyses, select baseline characteristics were associated with improved OS for nivolumab.",2021,"Objective response rate was 13.7% versus 16.5% (odds ratio, 0.80; 95% CI, 0.50-1.27); median duration of response was 8.3 versus 4.5 months.","['Patients with relapsed small-cell lung cancer (SCLC', 'Patients with relapse after first-line platinum-based chemotherapy', 'CheckMate 331', '284 patients were randomized to nivolumab and 285 to chemotherapy']","['nivolumab versus standard chemotherapy', 'nivolumab', 'OS (nivolumab vs chemotherapy', 'Second-Line Nivolumab', 'nivolumab versus chemotherapy', 'nivolumab 240 mg every 2 weeks or chemotherapy (topotecan or amrubicin']","['survival', 'overall survival (OS', 'OS', 'median duration of response', 'Objective response rate', 'adverse events', 'Median progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278727', 'cui_str': 'Small cell lung cancer recurrent'}, {'cui': 'C0149925', 'cui_str': 'Small cell carcinoma of lung'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0146224', 'cui_str': 'Topotecan'}, {'cui': 'C0762659', 'cui_str': 'amrubicin'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",284.0,0.199279,"Objective response rate was 13.7% versus 16.5% (odds ratio, 0.80; 95% CI, 0.50-1.27); median duration of response was 8.3 versus 4.5 months.","[{'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Spigel', 'Affiliation': 'Oncology Department, Sarah Cannon Research Institute/Tennessee Oncology, PLLC, Nashville, USA. Electronic address: David.spigel@sarahcannon.com.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Vicente', 'Affiliation': 'Department of Medical Oncology, Hosp Univ Virgen Macarena, Seville, Spain.'}, {'ForeName': 'T E', 'Initials': 'TE', 'LastName': 'Ciuleanu', 'Affiliation': 'Medical Oncology, Prof. Dr. Ion Chiricuta Institute of Oncology and UMF Iuliu Hatieganu, Cluj-Napoca, Romania.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gettinger', 'Affiliation': 'Medical Oncology, Yale Cancer Center, New Haven, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'Oncology Department, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Horn', 'Affiliation': 'Department of Medicine, Vanderbilt-Ingram Cancer Center, Nashville, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Audigier-Valette', 'Affiliation': 'Pulmonology Department, Hôpital Sainte Musse, Toulon, France.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Pardo Aranda', 'Affiliation': ""Thoracic Unit, Medical Oncology Department, Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), Barcelona.""}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Juan-Vidal', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario La Fe, Valencia, Spain.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Thoracic Oncology, Jilin Cancer Hospital, Changchun, Jilin, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Department of Oncology, Tangdu Hospital, Xi'an, Shaanxi, China.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Shi', 'Affiliation': 'Department of Medical Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Luft', 'Affiliation': 'Department of Thoracic Surgery, Leningrad Regional Clinical Hospital, St. Petersburg, Russian Federation.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wolf', 'Affiliation': 'Clinic I for Internal Medicine, Center for Integrated Oncology, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Antonia', 'Affiliation': 'Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Medical Oncology, Kindai University Hospital, Osaka, Japan.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Fairchild', 'Affiliation': 'Clinical Development, Bristol Myers Squibb, Princeton, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Baudelet', 'Affiliation': 'Global Drug Development, Biometrics & Data Sciences, Bristol Myers Squibb, Princeton, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Pandya', 'Affiliation': 'Translational Pathology, Bristol Myers Squibb, Princeton, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Doshi', 'Affiliation': 'Translational Medicine, Bristol Myers Squibb, Princeton, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Chang', 'Affiliation': 'Translational Bioinformatics, Bristol Myers Squibb, Princeton, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'Thoracic Oncology, LungenClinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2021.01.071'] 2081,33539945,Ibrutinib in combination with nab-paclitaxel and gemcitabine for first-line treatment of patients with metastatic pancreatic adenocarcinoma: phase III RESOLVE study.,"BACKGROUND First-line treatment of metastatic pancreatic ductal adenocarcinoma (PDAC) includes nab-paclitaxel/gemcitabine. Ibrutinib, a Bruton's tyrosine kinase inhibitor, exhibits antitumor activity through tumor microenvironment modulation. The safety and efficacy of first-line ibrutinib plus nab-paclitaxel/gemcitabine treatment in patients with PDAC were evaluated. PATIENTS AND METHODS RESOLVE (NCT02436668) was a phase III, randomized, double-blind, placebo-controlled study. Patients (histologically-confirmed PDAC; stage IV diagnosis ≥6 weeks of randomization; Karnofsky performance score ≥70) were randomized to once-daily oral ibrutinib (560 mg) or placebo plus nab-paclitaxel (125 mg/m 2 ) and gemcitabine (1000 mg/m 2 ). Primary endpoints were overall survival (OS) and investigator-assessed progression-free survival (PFS); overall response rate and safety were assessed. RESULTS In total, 424 patients were randomized (ibrutinib arm, n = 211; placebo arm, n = 213). Baseline characteristics were balanced across arms. After a median follow-up of 25 months, there was no significant difference in OS between ibrutinib plus nab-paclitaxel/gemcitabine versus placebo plus nab-paclitaxel/gemcitabine (median of 9.7 versus 10.8 months; P = 0.3225). PFS was shorter for ibrutinib plus nab-paclitaxel/gemcitabine compared with placebo plus nab-paclitaxel/gemcitabine (median 5.3 versus 6.0 months; P < 0.0001). Overall response rates were 29% and 42%, respectively (P = 0.0058). Patients in the ibrutinib arm had less time on treatment and received lower cumulative doses for all agents compared with the placebo arm. The most common grade ≥3 adverse events for ibrutinib versus placebo arms included neutropenia (24% versus 35%), peripheral sensory neuropathy (17% versus 8%), and anemia (16% versus 17%). Primary reasons for any treatment discontinuation were disease progression and adverse events. CONCLUSIONS Ibrutinib plus nab-paclitaxel/gemcitabine did not improve OS or PFS for patients with PDAC. Safety was consistent with known profiles for these agents.",2021,Patients in the ibrutinib arm had less time on treatment and received lower cumulative dose for all agents compared to placebo arm.,"['metastatic pancreatic ductal adenocarcinoma (PDAC', '424 patients were randomized (ibrutinib arm, n=211; placebo arm, n=213', 'Patients (histologically-confirmed PDAC; stage IV diagnosis ≥6 weeks of randomization; Karnofsky performance score ≥70', 'patients with PDAC was evaluated', 'Patients with Metastatic Pancreatic Adenocarcinoma', 'patients with PDAC']","['gemcitabine', 'first-line ibrutinib plus nab-paclitaxel/gemcitabine', 'placebo plus nab-paclitaxel', 'placebo', 'Ibrutinib in Combination with Nab-Paclitaxel and Gemcitabine', 'Ibrutinib plus nab-paclitaxel/gemcitabine', 'placebo plus nab-paclitaxel/gemcitabine', 'paclitaxel/gemcitabine vs placebo plus nab-paclitaxel/gemcitabine', 'paclitaxel/gemcitabine']","['PFS', 'disease progression and AEs', 'ORRs', 'anemia', 'OS or PFS', 'OS', 'safety and efficacy', 'peripheral sensory neuropathy', 'overall survival (OS) and investigator-assessed progression-free survival (PFS); overall response rate (ORR) and safety', 'neutropenia']","[{'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3501358', 'cui_str': 'Ibrutinib'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky performance status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0861727', 'cui_str': 'Pancreatic adenocarcinoma metastatic'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C3501358', 'cui_str': 'Ibrutinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}]",424.0,0.392036,Patients in the ibrutinib arm had less time on treatment and received lower cumulative dose for all agents compared to placebo arm.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tempero', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, USA. Electronic address: Margaret.Tempero@ucsf.edu.'}, {'ForeName': 'D-Y', 'Initials': 'DY', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine, Cancer Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tabernero', 'Affiliation': ""Department of Medical Oncology, Vall d'Hebron University Hospital and Institute of Oncology (VHIO), IOB-Quiron, UVic-UICC, CIBERONC, Barcelona, Spain.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Reni', 'Affiliation': 'Department of Radiochemotherapy, San Raffaele Hospital Scientific Institute, Milan, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'Department of Digestive Oncology, University Hospitals Gasthuisberg/Leuven & KU Leuven, Leuven, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hendifar', 'Affiliation': 'Department of Medical Oncology, Cedars-Sinai Medical Center, Los Angeles, USA.'}, {'ForeName': 'D-T', 'Initials': 'DT', 'LastName': 'Waldschmidt', 'Affiliation': 'Department of General, Visceral and Cancer Surgery, University of Cologne, Köln, Germany.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Starling', 'Affiliation': 'Section of GI and Lymphoma Units, Department of Medicine, The Royal Marsden, London, UK.'}, {'ForeName': 'J-B', 'Initials': 'JB', 'LastName': 'Bachet', 'Affiliation': 'Department of Hepatogastroenterology, UPMC, Sorbonne University, Pitié Salpêtrière Hospital, APHP, Paris, France.'}, {'ForeName': 'H-M', 'Initials': 'HM', 'LastName': 'Chang', 'Affiliation': 'Division of Oncology, Department of Internal Medicine, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Maurel', 'Affiliation': 'Department of Medical Oncology, Translational Genomics and Targeted Therapeutics in Solid Tumors Group, IDIBAPS, Hospital Clinic Barcelona, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Garcia-Carbonero', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario Doce de Octubre, Imas12, UCM, CNIO, CIBERONC, Madrid, Spain.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Dipartimento di Oncologia Clinical e Sperimentale, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.'}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Coussens', 'Affiliation': 'Department of Cell, Developmental & Cancer Biology, Knight Cancer Institute, Oregon Health & Science University, Portland, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Fong', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, USA.'}, {'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Tsao', 'Affiliation': 'Department of Statistics, Pharmacyclics LLC, an AbbVie Company, Sunnyvale, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Cole', 'Affiliation': 'Department of Oncology Development, Pharmacyclics LLC, an AbbVie Company, Sunnyvale, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'James', 'Affiliation': 'Department of Clinical Science, Pharmacyclics LLC, an AbbVie Company, Sunnyvale, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Macarulla', 'Affiliation': ""Department of Medical Oncology, Vall d'Hebron University Hospital and Institute of Oncology (VHIO), IOB-Quiron, UVic-UICC, CIBERONC, Barcelona, Spain.""}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2021.01.070'] 2082,33539944,"A phase II randomized trial of cobimetinib plus chemotherapy, with or without atezolizumab, as first-line treatment for patients with locally advanced or metastatic triple-negative breast cancer (COLET): primary analysis.","BACKGROUND Resistance to standard chemotherapy in metastatic triple-negative breast cancer (mTNBC) is associated with upregulation of the mitogen-activated protein kinase (MAPK) pathway. Cobimetinib, an MAPK/extracellular signal-regulated kinase (MEK) inhibitor, may increase sensitivity to taxanes and programmed death-ligand 1 inhibitors. COLET is a three-cohort phase II study evaluating first-line cobimetinib plus chemotherapy, with or without atezolizumab, in patients with locally advanced or mTNBC. PATIENTS AND METHODS Patients were ≥18 years with locally advanced or mTNBC. Following a safety run-in, patients in cohort I were randomized 1:1 to cobimetinib (60 mg, D3-D23 of each 28-day cycle) or placebo, plus paclitaxel (80 mg/m 2 , D1, 8, and 15). Additional patients were randomized (1:1) to cohort II or III to receive cobimetinib plus atezolizumab (840 mg, D1 and D15) and either paclitaxel (cohort II) or nab-paclitaxel [cohort III (100 mg/m 2 , D1, D8, and D15)]. Primary endpoints were investigator-assessed progression-free survival (PFS) (cohort I) and confirmed objective response rate (ORR) (cohorts II/III). Safety and tolerability were also assessed. RESULTS In the expansion stages, median PFS was 5.5 months for cobimetinib/paclitaxel versus 3.8 months for placebo/paclitaxel in cohort I [hazard ratio 0.73; 95% confidence interval (CI) 0.43-1.24; P = 0.25]. In cohort I, ORR was 38.3% (95% CI 24.40-52.20) for cobimetinib/paclitaxel and 20.9% (95% CI 8.77-33.09) for placebo/paclitaxel; ORRs in cohorts II and III were 34.4% (95% CI 18.57-53.19) and 29.0% (95% CI 14.22-48.04), respectively. Diarrhea was the most common grade ≥3 adverse events across all cohorts. CONCLUSIONS Cobimetinib added to paclitaxel did not lead to a statistically significant increase in PFS or ORR, although a nonsignificant trend toward a numerical increase was observed. Cobimetinib plus atezolizumab and a taxane did not appear to increase ORR. This demonstrates the potential activity of a combinatorial MEK inhibitor, chemotherapy, and immunotherapy in this difficult-to-treat population.",2021,"I, ORR was 38.3% (95% CI 24.40-52.20) for cobimetinib/paclitaxel and 20.9% (95% CI 8.77-33.09) for placebo/paclitaxel; ORRs in Cohorts II and III were 34.4% (95% CI 18.57-53.19) and 29.0% (95% CI 14.22-48.04), respectively.","['Patients were ≥18 years with locally advanced or mTNBC', 'patients with locally advanced or mTNBC', 'patients with locally advanced or metastatic triple-negative breast cancer (COLET', 'metastatic triple-negative breast cancer (mTNBC']","['paclitaxel', 'cobimetinib', 'standard chemotherapy', 'taxane', 'atezolizumab', 'cobimetinib plus chemotherapy, with or without atezolizumab', 'cobimetinib plus atezolizumab', 'Cobimetinib plus atezolizumab', 'paclitaxel (Cohort II) or nab-paclitaxel (Cohort III', 'placebo, plus paclitaxel', 'placebo/paclitaxel']","['Diarrhea', 'PFS or ORR', 'ORR', 'median PFS', 'Safety/tolerability', 'investigator-assessed progression-free survival (PFS) (Cohort I) and confirmed objective response rate (ORR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C4049146', 'cui_str': 'Cobimetinib'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]",,0.245477,"I, ORR was 38.3% (95% CI 24.40-52.20) for cobimetinib/paclitaxel and 20.9% (95% CI 8.77-33.09) for placebo/paclitaxel; ORRs in Cohorts II and III were 34.4% (95% CI 18.57-53.19) and 29.0% (95% CI 14.22-48.04), respectively.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Brufsky', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, University of Pittsburgh Medical Center, Pittsburgh, USA. Electronic address: brufskyam@upmc.edu.'}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ž', 'Initials': 'Ž', 'LastName': 'Zvirbule', 'Affiliation': 'Department of Oncology, Latvian Oncology Centre of Riga East Clinical University Hospital, Riga, Latvia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Eniu', 'Affiliation': ""Department of Breast Tumors, Cancer Institute 'Prof. Dr. Ion Chiricuţă' (IOCN), Cluj-Napoca, Romania.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mebis', 'Affiliation': 'Department of Medical Oncology, Jessa Ziekenhuis, University of Hasselt, Belgium.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Sohn', 'Affiliation': 'Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wongchenko', 'Affiliation': 'Genentech, Inc., South San Francisco, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chohan', 'Affiliation': 'F. Hoffmann-La Roche, Ltd., Mississauga, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Amin', 'Affiliation': 'Genentech, Inc., South San Francisco, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Genentech, Inc., South San Francisco, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'McNally', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Miles', 'Affiliation': 'Mount Vernon Cancer Centre, Northwood, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loi', 'Affiliation': 'Division of Clinical Medicine and Research, Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Australia. Electronic address: sherene.loi@petermac.org.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2021.01.065'] 2083,33539541,A novel three-dimensional morphological analysis of idiopathic condylar resorption following stabilisation splint treatment.,"Bone modelling evaluation is important for monitoring idiopathic condylar resorption (ICR) progress. To compare condylar modelling in ICR patients treated with or without stabilisation splints (SSs). Eighty-four condyles from 84 ICR patients were studied: 42 received SS therapy (SS group); 42 received conventional therapy (control group). Cone-beam computed tomography images at diagnosis (T0) and after at least 6 months (T1) were used for three-dimensional reconstruction. Volume differences between T0 and T1 (δV) were used to evaluate the amount of modelling. Percentage of growth area (PCT) was used to assess the condylar surface growth tendency. No significant change in condylar volume was found in the SS group, whereas that in the control group was significantly decreased at T1 (P <.0001). The amount of modelling differed among condylar subregions within the SS group: among 6 subregions (P =.0137), between anterior and posterior regions (P =.0336) and between lateral, intermediate and medial regions (P =.0275). Control group condylar subregions showed no significant differences in the amount of modelling. The anabolic modelling tendency of the total condylar surface in the SS group was greater than that in the control group (P =.0251); however, there were no statistical differences in PCTs among condylar subregions in either group. SS therapy effectively reduced further bone destruction and promoted condylar modelling. Three-dimensional morphological analysis is a novel method that can accurately evaluate the amount of bone modelling and growth tendency in ICR patients.",2021,"The anabolic modelling tendency of the total condylar surface in the SS group was greater than that in the control group (P=0.0251); however, there were no statistical differences in PCTs among condylar subregions in either group. ","['ICR patients', 'ICR patients treated with or without stabilisation splints (SSs', '84 condyles from 84 ICR patients were studied: 42 received']","['SS therapy (SS group); 42 received conventional therapy (control group', 'stabilisation splint treatment']","['bone destruction and promoted condylar modelling', 'Percentage of growth area (PCT', 'total condylar surface', 'idiopathic condylar resorption', 'condylar volume']","[{'cui': 'C4552164', 'cui_str': 'Idiopathic condylar resorption'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0037052', 'cui_str': 'Sick sinus syndrome'}, {'cui': 'C0524414', 'cui_str': 'Structure of condyle'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0238790', 'cui_str': 'Bone destruction'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C4552164', 'cui_str': 'Idiopathic condylar resorption'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",84.0,0.0118548,"The anabolic modelling tendency of the total condylar surface in the SS group was greater than that in the control group (P=0.0251); however, there were no statistical differences in PCTs among condylar subregions in either group. ","[{'ForeName': 'Jialiang', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'State Key Laboratory of Oral Disease, Department of Orthodontics, West China School of Stomatology, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Yujie', 'Initials': 'Y', 'LastName': 'Fu', 'Affiliation': 'School and Hospital of Stomatology, Tongji University, Shanghai Engineering Research Centre of Tooth Restoration and Regeneration, Shanghai, China.'}, {'ForeName': 'Lixia', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'State Key Laboratory of Oral Disease, Department of Temporomandibular Joint, West China School of Stomatology, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Ziyu', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Oral Disease, Department of Orthodontics, West China School of Stomatology, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Oral Disease, Department of Orthodontics, West China School of Stomatology, Sichuan University, Chengdu, Sichuan, China.'}]",Journal of oral rehabilitation,['10.1111/joor.13154'] 2084,33530006,A Clinical Trial of a Video Intervention Targeting Opioid Disposal After General Surgery: A Feasibility Study.,"BACKGROUND The opioid epidemic continues and although some initiatives have shown promise in reducing the number of opiates prescribed, few studies have focused on education of general surgery patients about home storage and safe disposal. The purpose of this feasibility study was to explore the use of an online video intervention to prepare surgical patients to properly dispose of unused opioids. METHODS Eligible patients undergoing elective general surgery between August and October 2019 were enrolled into this prospective randomized controlled feasibility study. Patients with reported opioid use preoperatively were excluded from the study. The control group followed usual care, and the intervention group received usual care plus a brief educational video guided by the theory of reasoned action describing safe storage and disposal practices of unused opioid pills. Measures were collected at baseline and 2 wk postoperatively. RESULTS A total of 40 participants were enrolled in the study; average age was 44.7 (range 21-75 y); most were Caucasian, educated, and employed. Recruitment took 11 wk, and the retention rate was excellent at 85%. Differences in opioid disposal were not significantly different by age, sex, education, or type of surgery. The video intervention was positively received, but the majority (80%) still stored their pills unsecured. CONCLUSIONS Results demonstrate that a video intervention addressing safe storage and disposal practices of unused opioids is feasible, and more research is needed to determine efficacy in increasing rates of secure storage and disposal of unused opioid pills.",2021,"The control group followed usual care, and the intervention group received usual care plus a brief educational video guided by the theory of reasoned action describing safe storage and disposal practices of unused opioid pills.","['Patients with reported opioid use preoperatively were excluded from the study', 'surgical patients to properly dispose of unused opioids', 'A total of 40 participants were enrolled in the study; average age was 44.7 (range 21-75\xa0y); most were Caucasian, educated, and employed', 'Eligible patients undergoing elective general surgery between August and October 2019']","['control group followed usual care, and the intervention group received usual care plus a brief educational video guided by the theory of reasoned action describing safe storage and disposal practices of unused opioid pills', 'Video Intervention Targeting Opioid Disposal', 'online video intervention']","['retention rate', 'opioid disposal']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0445107', 'cui_str': 'Not used'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1274039', 'cui_str': 'General surgery'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0445107', 'cui_str': 'Not used'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]",40.0,0.0885486,"The control group followed usual care, and the intervention group received usual care plus a brief educational video guided by the theory of reasoned action describing safe storage and disposal practices of unused opioid pills.","[{'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Lewis', 'Affiliation': 'University of Massachusetts Medical School, Graduate School of Nursing, Worcester, Massachusetts. Electronic address: Joanne.lewis@umassmed.edu.'}, {'ForeName': 'Sybil', 'Initials': 'S', 'LastName': 'Crawford', 'Affiliation': 'University of Massachusetts Medical School, Graduate School of Nursing, Worcester, Massachusetts.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Sullivan-Boylai', 'Affiliation': 'University of Massachusetts Medical School, Graduate School of Nursing, Worcester, Massachusetts.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Poza', 'Affiliation': 'University of Massachusetts Medical School, Graduate School of Nursing, Worcester, Massachusetts.'}]",The Journal of surgical research,['10.1016/j.jss.2020.12.010'] 2085,33544305,"Onset, Maintenance, and Cessation of Effect of Galcanezumab for Prevention of Migraine: A Narrative Review of Three Randomized Placebo-Controlled Trials.","INTRODUCTION Galcanezumab, a humanized monoclonal antibody that binds to calcitonin gene-related peptide, is approved for the preventive treatment of migraine in adults. It is self-administered once monthly as a subcutaneous injection. This paper describes the time course of effect of galcanezumab in patients with episodic and chronic migraine. METHODS Data were based on three double-blind, placebo-controlled, phase 3 studies. Patients (1773 episodic and 1113 chronic) were randomized (2:1:1) to monthly doses of placebo, galcanezumab 120 mg with a 240 mg loading dose, or galcanezumab 240 mg (January 2016-March 2017). Onset of effect was determined using a sequential analysis approach based on earliest time point at which galcanezumab achieved and subsequently maintained statistical superiority to placebo. Maintenance of effect was a comparison of the percentages of galcanezumab- and placebo-treated patients with maintenance of at least 50% response at the individual patient level. Cessation of effect was determined during a 4-month post-treatment period on the basis of change from baseline in monthly migraine headache days. RESULTS Galcanezumab led to a lower percentage of patients who had a migraine headache on the first day after injection, provided maintenance of effect throughout the duration of the double-blind treatment period, and gradually lost effect without signs of rebound headache throughout the post-treatment period in most patients with episodic and chronic migraine. CONCLUSION Galcanezumab is a novel preventive therapeutic option for adult patients with migraine that has early onset of action, maintenance of effect, and gradual reduction of effect upon treatment cessation. TRIAL REGISTRATION ClinicalTrials.gov: NCT02614183 (EVOLVE-1); NCT02614196 (EVOLVE-2); NCT02614261 (REGAIN).",2021,"RESULTS Galcanezumab led to a lower percentage of patients who had a migraine headache on the first day after injection, provided maintenance of effect throughout the duration of the double-blind treatment period, and gradually lost effect without signs of rebound headache throughout the post-treatment period in most patients with episodic and chronic migraine. ","['treated patients with maintenance of at least 50% response at the individual patient level', 'patients with episodic and chronic migraine', 'Patients (1773 episodic and 1113 chronic', 'adult patients with migraine', 'Migraine']","['galcanezumab- and placebo', 'galcanezumab', 'placebo', 'Galcanezumab', 'placebo, galcanezumab 120\xa0mg with a 240\xa0mg loading dose, or galcanezumab', 'Placebo']","['rebound headache', 'migraine headache']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}]","[{'cui': 'C4694273', 'cui_str': 'galcanezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0520961', 'cui_str': 'Drug withdrawal headache'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}]",,0.233367,"RESULTS Galcanezumab led to a lower percentage of patients who had a migraine headache on the first day after injection, provided maintenance of effect throughout the duration of the double-blind treatment period, and gradually lost effect without signs of rebound headache throughout the post-treatment period in most patients with episodic and chronic migraine. ","[{'ForeName': 'Dulanji K', 'Initials': 'DK', 'LastName': 'Kuruppu', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA. kuruppu_dulanji@lilly.com.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'North', 'Affiliation': 'Health Center on Broad Street, Glens Falls, NY, USA.'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Kovacik', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Pearlman', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Hutchinson', 'Affiliation': 'Orange County Migraine and Headache Center, Irvine, CA, USA.'}]",Advances in therapy,['10.1007/s12325-021-01632-x'] 2086,33544277,Improved Parent-Child Interactions Predict Reduced Internalizing Symptoms Among the Offspring of Parents with Bipolar Disorder Undergoing a Prevention Program: A Proof-of-Concept Study.,"The offspring of parents with bipolar disorder (OBD) exhibit elevated rates of psychopathology. However, preventative interventions are lacking. Using a quasi-experimental design with an assessment-only control group, we examined if a 12-week program (entitled Reducing Unwanted Stress in the Home, RUSH) decreases internalizing and externalizing symptoms in the OBD (aged 6-11 years) via intervention-related gains in parent-child interaction quality. Participants consisted of 55 offspring (26 OBD; 29 controls) and their parents. Assessments were conducted at four time points up to six months following the end of the RUSH program, during which parent and teacher ratings of child symptoms, and parent-child interaction quality (parental positivity and negativity, and dyadic mutuality) were measured. Multilevel modelling showed improved parental positivity and negativity, and dyadic mutuality among target dyads immediately and six months post-intervention. For the bootstrapping mediation analyses, intervention-related change in parental negativity fully mediated the relations between having participated in the RUSH program and lower parent-reported internalizing problems among the OBD six months later. These data provide evidence of the efficacy of the RUSH program for OBD who exhibited improved interactions with their parents post-intervention. Further investigation via a randomized controlled trial is warranted.",2021,"Multilevel modelling showed improved parental positivity and negativity, and dyadic mutuality among target dyads immediately and six months post-intervention.","['parents with bipolar disorder (OBD', 'Participants consisted of 55 offspring (26 OBD; 29 controls) and their parents', 'Offspring of Parents with Bipolar Disorder Undergoing a Prevention Program']",[],"['parental positivity and negativity, and dyadic mutuality', 'internalizing and externalizing symptoms', 'teacher ratings of child symptoms, and parent-child interaction quality (parental positivity and negativity, and dyadic mutuality']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",55.0,0.0340301,"Multilevel modelling showed improved parental positivity and negativity, and dyadic mutuality among target dyads immediately and six months post-intervention.","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Serravalle', 'Affiliation': 'Centre for Research in Human Development, Concordia University, Québec, Montréal, Canada.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Iacono', 'Affiliation': 'Centre for Research in Human Development, Concordia University, Québec, Montréal, Canada.'}, {'ForeName': 'Alexa L', 'Initials': 'AL', 'LastName': 'Wilson', 'Affiliation': 'Department of Psychology, University of Montreal, Québec, Montréal, Canada.'}, {'ForeName': 'Mark Anthony', 'Initials': 'MA', 'LastName': 'Orlando', 'Affiliation': 'Centre for Research in Human Development, Concordia University, Québec, Montréal, Canada.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Tsekova', 'Affiliation': 'Department of Psychology, Ryerson University, Toronto, Ontario, Canada.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Ellenbogen', 'Affiliation': 'Centre for Research in Human Development, Concordia University, Québec, Montréal, Canada. mark.ellenbogen@concordia.ca.'}]",Research on child and adolescent psychopathology,['10.1007/s10802-020-00743-3'] 2087,33471452,Lower or Higher Oxygenation Targets for Acute Hypoxemic Respiratory Failure.,"BACKGROUND Patients with acute hypoxemic respiratory failure in the intensive care unit (ICU) are treated with supplemental oxygen, but the benefits and harms of different oxygenation targets are unclear. We hypothesized that using a lower target for partial pressure of arterial oxygen (Pao 2 ) would result in lower mortality than using a higher target. METHODS In this multicenter trial, we randomly assigned 2928 adult patients who had recently been admitted to the ICU (≤12 hours before randomization) and who were receiving at least 10 liters of oxygen per minute in an open system or had a fraction of inspired oxygen of at least 0.50 in a closed system to receive oxygen therapy targeting a Pao 2 of either 60 mm Hg (lower-oxygenation group) or 90 mm Hg (higher-oxygenation group) for a maximum of 90 days. The primary outcome was death within 90 days. RESULTS At 90 days, 618 of 1441 patients (42.9%) in the lower-oxygenation group and 613 of 1447 patients (42.4%) in the higher-oxygenation group had died (adjusted risk ratio, 1.02; 95% confidence interval, 0.94 to 1.11; P = 0.64). At 90 days, there was no significant between-group difference in the percentage of days that patients were alive without life support or in the percentage of days they were alive after hospital discharge. The percentages of patients who had new episodes of shock, myocardial ischemia, ischemic stroke, or intestinal ischemia were similar in the two groups (P = 0.24). CONCLUSIONS Among adult patients with acute hypoxemic respiratory failure in the ICU, a lower oxygenation target did not result in lower mortality than a higher target at 90 days. (Funded by the Innovation Fund Denmark and others; HOT-ICU ClinicalTrials.gov number, NCT03174002.).",2021,"At 90 days, there was no significant between-group difference in the percentage of days that patients were alive without life support or in the percentage of days they were alive after hospital discharge.","['adult patients with acute hypoxemic respiratory failure', 'Acute Hypoxemic Respiratory Failure', '2928 adult patients who had recently been admitted to the ICU (≤12 hours before randomization) and who were receiving at least 10 liters of oxygen per minute in an open system or had a fraction of inspired oxygen of at least 0.50 in a closed system to receive', 'Patients with acute hypoxemic respiratory failure in the intensive care unit (ICU']",['oxygen therapy targeting a Pao 2 of either 60 mm Hg (lower-oxygenation group) or 90 mm Hg (higher-oxygenation group'],"['new episodes of shock, myocardial ischemia, ischemic stroke, or intestinal ischemia', 'death within 90 days', 'lower mortality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4039867', 'cui_str': 'Acute hypoxemic respiratory failure'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0475211', 'cui_str': 'L'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0587267', 'cui_str': 'Closed'}]","[{'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0565959', 'cui_str': 'New episode'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0156149', 'cui_str': 'Gastrointestinal tract vascular insufficiency'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",2928.0,0.447975,"At 90 days, there was no significant between-group difference in the percentage of days that patients were alive without life support or in the percentage of days they were alive after hospital discharge.","[{'ForeName': 'Olav L', 'Initials': 'OL', 'LastName': 'Schjørring', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Klitgaard', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Perner', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Jørn', 'Initials': 'J', 'LastName': 'Wetterslev', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Siegemund', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Bäcklund', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Keus', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Jon H', 'Initials': 'JH', 'LastName': 'Laake', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Morgan', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Katrin M', 'Initials': 'KM', 'LastName': 'Thormar', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Søren A', 'Initials': 'SA', 'LastName': 'Rosborg', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Jannie', 'Initials': 'J', 'LastName': 'Bisgaard', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Annette E S', 'Initials': 'AES', 'LastName': 'Erntgaard', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Anne-Sofie H', 'Initials': 'AH', 'LastName': 'Lynnerup', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Rasmus L', 'Initials': 'RL', 'LastName': 'Pedersen', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Crescioli', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Theis C', 'Initials': 'TC', 'LastName': 'Gielstrup', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Meike T', 'Initials': 'MT', 'LastName': 'Behzadi', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Lone M', 'Initials': 'LM', 'LastName': 'Poulsen', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Stine', 'Initials': 'S', 'LastName': 'Estrup', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Jens P', 'Initials': 'JP', 'LastName': 'Laigaard', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Cheme', 'Initials': 'C', 'LastName': 'Andersen', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Camilla B', 'Initials': 'CB', 'LastName': 'Mortensen', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Björn A', 'Initials': 'BA', 'LastName': 'Brand', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'White', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Inge-Lise', 'Initials': 'IL', 'LastName': 'Jarnvig', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Morten H', 'Initials': 'MH', 'LastName': 'Møller', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Quist', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Morten H', 'Initials': 'MH', 'LastName': 'Bestle', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schønemann-Lund', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Maj K', 'Initials': 'MK', 'LastName': 'Kamper', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Hindborg', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Alexa', 'Initials': 'A', 'LastName': 'Hollinger', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Caroline E', 'Initials': 'CE', 'LastName': 'Gebhard', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Zellweger', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Meyhoff', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Hjort', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Bech', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Thorbjørn', 'Initials': 'T', 'LastName': 'Grøfte', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Bundgaard', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Lars H M', 'Initials': 'LHM', 'LastName': 'Østergaard', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Thyø', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hildebrandt', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Bülent', 'Initials': 'B', 'LastName': 'Uslu', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Christoffer G', 'Initials': 'CG', 'LastName': 'Sølling', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Nette', 'Initials': 'N', 'LastName': 'Møller-Nielsen', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'Brøchner', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Borup', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Marjatta', 'Initials': 'M', 'LastName': 'Okkonen', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'Dieperink', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Ulf G', 'Initials': 'UG', 'LastName': 'Pedersen', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Anne S', 'Initials': 'AS', 'LastName': 'Andreasen', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Buus', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Tayyba N', 'Initials': 'TN', 'LastName': 'Aslam', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Winding', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Joerg C', 'Initials': 'JC', 'LastName': 'Schefold', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Stine B', 'Initials': 'SB', 'LastName': 'Thorup', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Susanne A', 'Initials': 'SA', 'LastName': 'Iversen', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Janus', 'Initials': 'J', 'LastName': 'Engstrøm', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Maj-Brit N', 'Initials': 'MN', 'LastName': 'Kjær', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': 'Bodil S', 'Initials': 'BS', 'LastName': 'Rasmussen', 'Affiliation': 'From the Department of Anesthesia and Intensive Care, Aalborg University Hospital, Aalborg University, Aalborg (O.L.S., T.L.K., S.A.R., J.B., A.E.S.E., A.-S.H.L., R.L.P., E.C., T.C.G., M.T.B., B.S.R.), Zealand University Hospital, Køge (L.M.P., S.E., J.P.L., C.A., C.B.M.), Rigshospitalet (A.P., B.A.B., J. Wetterslev, I.-L.J., M.H.M., L.Q., M.-B.N.K.) and the Section of Biostatistics, Department of Public Health (T.L.), University of Copenhagen, Bispebjerg, and Frederiksberg Hospital (C.S.M., M. Hjort, L.K.B.) and the Copenhagen Trial Unit (J. White, J.E.), Copenhagen, Nordsjaellands Hospital, Hillerod (M.H.B., M.S.-L., M.K.K., M. Hindborg), Randers Hospital, Randers (T.G., H.B.), Aarhus University Hospital, Skejby North, Aarhus (L.H.M.Ø., M.A.T.), Zealand University Hospital, Roskilde (T.H., B.U.), Viborg Hospital, Viborg (C.G.S., N.M.-N.), Kolding Hospital, Kolding (A.C.B., M. Bäcklund), Hvidovre Hospital, Hvidovre (U.G.P.), Herlev Hospital, Herlev (A.S.A.), Horsens Hospital, Horsens (L.B.), Herning Hospital, Herning (R.R.W.), Holbæk Hospital, Holbæk (S.B.T.), and Slagelse Hospital, Slagelse (S.A.I.) - all in Denmark; the Department of Intensive Care and Department of Clinical Research, University of Basel, Basel (M.S., A.H., C.E.G., N.Z.), and the Department of Intensive Care, Inselspital, University of Bern, Bern (J.C.S.) - both in Switzerland; the Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki (M.B., M.O.); the Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands (F.K., W.D.); the Departments of Anesthesia and Intensive Care and of Clinical Research, Rikshospitalet, Oslo University Hospital, Oslo (J.H.L., T.N.A.); the Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, United Kingdom (M.M.); and the Department of Anesthesia and Intensive Care, Landspitali University Hospital, Reykjavik, Iceland (K.M.T.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2032510'] 2088,33531690,Serum alpha-fetoprotein and clinical outcomes in patients with advanced hepatocellular carcinoma treated with ramucirumab.,"BACKGROUND Post hoc analyses assessed the prognostic and predictive value of baseline alpha-fetoprotein (AFP), as well as clinical outcomes by AFP response or progression, during treatment in two placebo-controlled trials (REACH, REACH-2). METHODS Serum AFP was measured at baseline and every three cycles. The prognostic and predictive value of baseline AFP was assessed by Cox regression models and Subpopulation Treatment Effect Pattern Plot method. Associations between AFP (≥ 20% increase) and radiographic progression and efficacy were assessed. RESULTS Baseline AFP was confirmed as a continuous (REACH, REACH-2; p < 0.0001) and dichotomous (≥400 vs. <400 ng/ml; REACH, p < 0.01) prognostic factor, and was predictive for ramucirumab survival benefit in REACH (p = 0.0042 continuous; p < 0.0001 dichotomous). Time to AFP (hazard ratio [HR] 0.513; p < 0.0001) and radiographic (HR 0.549; p < 0.0001) progression favoured ramucirumab. Association between AFP and radiographic progression was shown for up to 6 (odds ratio [OR] 5.1; p < 0.0001) and 6-12 weeks (OR 1.8; p = 0.0065). AFP response was higher with ramucirumab vs. placebo (p < 0.0001). Survival was longer in patients with an AFP response than patients without (13.6 vs. 5.6 months, HR 0.451; 95% confidence interval, 0.354-0.574; p < 0.0001). CONCLUSIONS AFP is an important prognostic factor and a predictive biomarker for ramucirumab survival benefit. AFP ≥ 400 ng/ml is an appropriate selection criterion for ramucirumab. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, REACH (NCT01140347) and REACH-2 (NCT02435433).",2021,AFP response was higher with ramucirumab vs. placebo (p < 0.0001).,"['patients with advanced hepatocellular carcinoma treated with', 'AFP\u2009≥\u2009400']","['ramucirumab vs. placebo', 'ramucirumab']","['AFP and radiographic progression', 'Serum alpha-fetoprotein and clinical outcomes', 'Survival', 'AFP response', 'radiographic progression and efficacy', 'Serum AFP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0002210', 'cui_str': 'Alpha fetoprotein'}, {'cui': 'C3816746', 'cui_str': '400'}]","[{'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0002210', 'cui_str': 'Alpha fetoprotein'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0373538', 'cui_str': 'Alpha-1-fetoprotein measurement, serum'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.324213,AFP response was higher with ramucirumab vs. placebo (p < 0.0001).,"[{'ForeName': 'Andrew X', 'Initials': 'AX', 'LastName': 'Zhu', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, MA, USA. azhu@mgh.harvard.edu.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Finn', 'Affiliation': 'Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Yoon-Koo', 'Initials': 'YK', 'LastName': 'Kang', 'Affiliation': 'Asan Medical Center, University of Ulsan, Seoul, South Korea.'}, {'ForeName': 'Chia-Jui', 'Initials': 'CJ', 'LastName': 'Yen', 'Affiliation': 'National Cheng Kung University Hospital, Tainan, Taiwan.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Galle', 'Affiliation': 'University Medical Center, Mainz, Germany.'}, {'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Llovet', 'Affiliation': 'Liver Cancer Program, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Assenat', 'Affiliation': 'Department of Medical Oncology, CHU de Montpellier, Montpellier, France.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Brandi', 'Affiliation': 'University Hospital S.Orsola-Malpighi, Bologna, Italy.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Motomura', 'Affiliation': 'Aso Iizuka Hospital, Fukuoka, Japan.'}, {'ForeName': 'Izumi', 'Initials': 'I', 'LastName': 'Ohno', 'Affiliation': 'National Cancer Center Hospital East-Hepatobiliary and Pancreatic Oncology, Kashiwa, Japan.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Daniele', 'Affiliation': 'Azienda Ospedaliera Gaetano Rummo, Benevento, Italy.'}, {'ForeName': 'Arndt', 'Initials': 'A', 'LastName': 'Vogel', 'Affiliation': 'Medizinische Hochschule Hannover, Hannover, Germany.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': 'Graduate School of Medicine, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Chih-Hung', 'Initials': 'CH', 'LastName': 'Hsu', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Gerken', 'Affiliation': 'Universtitätsklinikum Essen AöR, Essen, Germany.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bilbruck', 'Affiliation': 'Envision Pharma Group, Horsham, UK.'}, {'ForeName': 'Yanzhi', 'Initials': 'Y', 'LastName': 'Hsu', 'Affiliation': 'Eli Lilly and Company, New York, NY, USA.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Liang', 'Affiliation': 'Eli Lilly and Company, Branchburg, NJ, USA.'}, {'ForeName': 'Ryan C', 'Initials': 'RC', 'LastName': 'Widau', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Chunxiao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Abada', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': 'Kindai University, Osaka, Japan.'}]",British journal of cancer,['10.1038/s41416-021-01260-w'] 2089,33538790,Efficacy of Endocrine Therapy for the Treatment of Breast Cancer in Men: Results from the MALE Phase 2 Randomized Clinical Trial.,"Importance The extent of changes in estradiol levels in male patients with hormone receptor-positive breast cancer receiving standard endocrine therapies is unknown. The sexual function and quality of life related to those changes have not been adequately evaluated. Objective To assess the changes in estradiol levels in male patients with breast cancer after 3 months of therapy. Design, Setting, and Participants This multicenter, phase 2 randomized clinical trial assessed 56 male patients with hormone receptor-positive breast cancer. Patients were recruited from 24 breast units across Germany between October 2012 and May 2017. The last patient completed 6 months of treatment in December 2017. The analysis data set was locked on August 24, 2018, and analysis was completed on December 19, 2018. Interventions Patients were randomized to 1 of 3 arms: tamoxifen alone or tamoxifen plus gonadotropin-releasing hormone analogue (GnRHa) or aromatase inhibitor (AI) plus GnRHa for 6 months. Main Outcomes and Measures The primary end point was the change in estradiol levels from baseline to 3 months. Secondary end points were changes of estradiol levels after 6 months, changes of additional hormonal parameters, adverse effects, sexual function, and quality of life after 3 and 6 months. Results In this phase 2 randomized clinical trial, a total of 52 of 56 male patients with a median (range) age of 61.5 (37-83) years started treatment. A total of 3 patients discontinued study treatment prematurely, 1 in each arm. A total of 50 patients were evaluable for the primary end point. After 3 months the patients' median estradiol levels increased by 67% (a change of +17.0 ng/L) with tamoxifen, decreased by 85% (-23.0 ng/L) with tamoxifen plus GnRHa, and decreased by 72% (-18.5 ng/L) with AI plus GnRHa (P < .001). After 6 months, median estradiol levels increased by 41% (a change of +12 ng/L) with tamoxifen, decreased by 61% (-19.5 ng/L) with tamoxifen plus GnRHa, and decreased by 64% (-17.0 ng/L) with AI plus GnRHa (P < .001). Sexual function and quality of life decreased when GnRHa was added but were unchanged with tamoxifen alone. Conclusions and Relevance This phase 2 randomized clinical trial found that AI or tamoxifen plus GnRHa vs tamoxifen alone led to a sustained decrease of estradiol levels. The decreased hormonal parameters were associated with impaired sexual function and quality of life. Trial Registration ClinicalTrials.gov Identifier: NCT01638247.",2021,"After 6 months, median estradiol levels increased by 41% (a change of +12 ng/L) with tamoxifen, decreased by 61% (-19.5 ng/L) with tamoxifen plus GnRHa, and decreased by 64% (-17.0 ng/L) with AI plus GnRHa (P < .001).","['total of 52 of 56 male patients with a median (range) age of 61.5 (37-83) years started treatment', '56 male patients with hormone receptor-positive breast cancer', 'male patients with breast cancer after 3 months of therapy', '50 patients were evaluable for the primary end point', 'Breast Cancer in Men', 'Patients were recruited from 24 breast units across Germany between October 2012 and May 2017', 'male patients with hormone receptor-positive breast cancer receiving']","['standard endocrine therapies', 'Endocrine Therapy', 'tamoxifen alone or tamoxifen plus gonadotropin-releasing hormone analogue (GnRHa) or aromatase inhibitor (AI) plus GnRHa', 'tamoxifen', 'AI or tamoxifen plus GnRHa vs tamoxifen']","['change in estradiol levels', 'sexual function and quality of life', 'Sexual function and quality of life', 'changes of estradiol levels after 6 months, changes of additional hormonal parameters, adverse effects, sexual function, and quality of life', 'estradiol levels', 'median estradiol levels']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0337434', 'cui_str': 'Estradiol measurement'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",56.0,0.288894,"After 6 months, median estradiol levels increased by 41% (a change of +12 ng/L) with tamoxifen, decreased by 61% (-19.5 ng/L) with tamoxifen plus GnRHa, and decreased by 64% (-17.0 ng/L) with AI plus GnRHa (P < .001).","[{'ForeName': 'Mattea', 'Initials': 'M', 'LastName': 'Reinisch', 'Affiliation': 'Breast Unit, Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Seiler', 'Affiliation': 'German Breast Group, GBG Forschungs GmbH Neu-Isenburg, Germany.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Hauzenberger', 'Affiliation': 'Klinikum St. Marien, Amberg, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Kamischke', 'Affiliation': 'MVZ Kinderwunschzentrum Münster, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schmatloch', 'Affiliation': 'Elisabeth Krankenhaus Kassel, Germany.'}, {'ForeName': 'Hans-Joachim', 'Initials': 'HJ', 'LastName': 'Strittmatter', 'Affiliation': 'Rems-Murr-Klinik-Winnenden, Germany.'}, {'ForeName': 'Dirk-Michael', 'Initials': 'DM', 'LastName': 'Zahm', 'Affiliation': 'SRH Wald-Klinikum, Gera, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Thode', 'Affiliation': 'Amedes MVZ Wagnerstibbe für Laboratoriumsmedizin, medizinische Mikrobiologie und Immunologie, Göttingen, Germany.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Furlanetto', 'Affiliation': 'German Breast Group, GBG Forschungs GmbH Neu-Isenburg, Germany.'}, {'ForeName': 'Dominika', 'Initials': 'D', 'LastName': 'Strik', 'Affiliation': 'Endokrinologikum Berlin, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Möbus', 'Affiliation': 'Department of Medicine II, Hematology and Oncology, Goethe University of Frankfurt, Germany.'}, {'ForeName': 'Toralf', 'Initials': 'T', 'LastName': 'Reimer', 'Affiliation': 'Universitätsfrauenklinik Rostock, Germany.'}, {'ForeName': 'Bruno Valentin', 'Initials': 'BV', 'LastName': 'Sinn', 'Affiliation': 'Department of Pathology, Charité - Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Elmar', 'Initials': 'E', 'LastName': 'Stickeler', 'Affiliation': 'Universitätsfrauenklinik Aachen, Germany.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Marmé', 'Affiliation': 'Universitätsfrauenklinik Mannheim, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Janni', 'Affiliation': 'Universitätsfrauenklinik Ulm, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Schmidt', 'Affiliation': 'Universitätsklinikum Mainz, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rudlowski', 'Affiliation': 'Evangelisches Krankenhaus Bergisch Gladbach, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Untch', 'Affiliation': 'Helios-Kliniken Berlin-Buch, Berlin, Germany.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Nekljudova', 'Affiliation': 'German Breast Group, GBG Forschungs GmbH Neu-Isenburg, Germany.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, GBG Forschungs GmbH Neu-Isenburg, Germany.'}]",JAMA oncology,['10.1001/jamaoncol.2020.7442'] 2090,33538782,Comparison of Multiparametric Magnetic Resonance Imaging-Targeted Biopsy With Systematic Transrectal Ultrasonography Biopsy for Biopsy-Naive Men at Risk for Prostate Cancer: A Phase 3 Randomized Clinical Trial.,"Importance Magnetic resonance imaging (MRI) with targeted biopsy is an appealing alternative to systematic 12-core transrectal ultrasonography (TRUS) biopsy for prostate cancer diagnosis, but has yet to be widely adopted. Objective To determine whether MRI with only targeted biopsy was noninferior to systematic TRUS biopsies in the detection of International Society of Urological Pathology grade group (GG) 2 or greater prostate cancer. Design, Setting, and Participants This multicenter, prospective randomized clinical trial was conducted in 5 Canadian academic health sciences centers between January 2017 and November 2019, and data were analyzed between January and March 2020. Participants included biopsy-naive men with a clinical suspicion of prostate cancer who were advised to undergo a prostate biopsy. Clinical suspicion was defined as a 5% or greater chance of GG2 or greater prostate cancer using the Prostate Cancer Prevention Trial Risk Calculator, version 2. Additional criteria were serum prostate-specific antigen levels of 20 ng/mL or less (to convert to micrograms per liter, multiply by 1) and no contraindication to MRI. Interventions Magnetic resonance imaging-targeted biopsy (MRI-TB) only if a lesion with a Prostate Imaging Reporting and Data System (PI-RADS), v 2.0, score of 3 or greater was identified vs 12-core systematic TRUS biopsy. Main Outcome and Measures The proportion of men with a diagnosis of GG2 or greater cancer. Secondary outcomes included the proportion who received a diagnosis of GG1 prostate cancer; GG3 or greater cancer; no significant cancer but subsequent positive MRI results and/or GG2 or greater cancer detected on a repeated biopsy by 2 years; and adverse events. Results The intention-to-treat population comprised 453 patients (367 [81.0%] White, 19 [4.2%] African Canadian, 32 [7.1%] Asian, and 10 [2.2%] Hispanic) who were randomized to undergo TRUS biopsy (226 [49.9%]) or MRI-TB (227 [51.1%]), of which 421 (93.0%) were evaluable per protocol. A lesion with a PI-RADS score of 3 or greater was detected in 138 of 221 men (62.4%) who underwent MRI, with 26 (12.1%), 82 (38.1%), and 30 (14.0%) having maximum PI-RADS scores of 3, 4, and 5, respectively. Eighty-three of 221 men who underwent MRI-TB (37%) had a negative MRI result and avoided biopsy. Cancers GG2 and greater were identified in 67 of 225 men (30%) who underwent TRUS biopsy vs 79 of 227 (35%) allocated to MRI-TB (absolute difference, 5%, 97.5% 1-sided CI, -3.4% to ∞; noninferiority margin, -5%). Adverse events were less common in the MRI-TB arm. Grade group 1 cancer detection was reduced by more than half in the MRI arm (from 22% to 10%; risk difference, -11.6%; 95% CI, -18.2% to -4.9%). Conclusions and Relevance Magnetic resonance imaging followed by selected targeted biopsy is noninferior to initial systematic biopsy in men at risk for prostate cancer in detecting GG2 or greater cancers. Trial Registration ClinicalTrials.gov Identifier: NCT02936258.",2021,"Cancers GG2 and greater were identified in 67 of 225 men (30%) who underwent TRUS biopsy vs 79 of 227 (35%) allocated to MRI-TB (absolute difference, 5%, 97.5% 1-sided CI, -3.4% to ∞; noninferiority margin, -5%).","['Eighty-three of 221 men who underwent MRI-TB (37%) had a negative MRI result and avoided biopsy', 'Biopsy-Naive Men at Risk for Prostate Cancer', 'African Canadian, 32 [7.1%] Asian, and 10 [2.2%] Hispanic', '5 Canadian academic health sciences centers between January 2017 and November 2019, and data were analyzed between January and March 2020', 'men with a diagnosis of GG2 or greater cancer', 'Participants included biopsy-naive men with a clinical suspicion of prostate cancer who were advised to undergo a prostate biopsy']","['Multiparametric Magnetic Resonance Imaging-Targeted Biopsy With Systematic Transrectal Ultrasonography Biopsy', 'Magnetic resonance imaging (MRI', 'transrectal ultrasonography (TRUS) biopsy']","['proportion who received a diagnosis of GG1 prostate cancer; GG3 or greater cancer; no significant cancer but subsequent positive MRI results and/or GG2 or greater cancer detected on a repeated biopsy by 2 years; and adverse events', 'Adverse events', 'Grade group 1 cancer detection', 'serum prostate-specific antigen levels']","[{'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242114', 'cui_str': 'Suspicion'}, {'cui': 'C1828381', 'cui_str': 'Recommendation - action'}, {'cui': 'C0194804', 'cui_str': 'Biopsy of prostate'}]","[{'cui': 'C3898221', 'cui_str': 'Multiparametric magnetic resonance elastography'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205518', 'cui_str': 'Transrectal approach'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332326', 'cui_str': 'Gleason grading system for prostatic cancer'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.218941,"Cancers GG2 and greater were identified in 67 of 225 men (30%) who underwent TRUS biopsy vs 79 of 227 (35%) allocated to MRI-TB (absolute difference, 5%, 97.5% 1-sided CI, -3.4% to ∞; noninferiority margin, -5%).","[{'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Klotz', 'Affiliation': 'Division of Urology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Chin', 'Affiliation': 'London Health Sciences Centre, University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Black', 'Affiliation': 'Vancouver Prostate Centre, Department of Urologic Sciences, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Finelli', 'Affiliation': 'Princess Margaret Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Anidjar', 'Affiliation': 'Jewish General Hospital, McGill University, Montreal, Québec, Canada.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Bladou', 'Affiliation': 'Division of Urology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Mercado', 'Affiliation': 'Vancouver Prostate Centre, Department of Urologic Sciences, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Levental', 'Affiliation': 'Jewish General Hospital, McGill University, Montreal, Québec, Canada.'}, {'ForeName': 'Sangeet', 'Initials': 'S', 'LastName': 'Ghai', 'Affiliation': 'Princess Margaret Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Sylvia D', 'Initials': 'SD', 'LastName': 'Chang', 'Affiliation': 'Department of Radiology, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Milot', 'Affiliation': 'Body and VIR Radiology Department, Hospices Civils de Lyon, Hospital Edouard Herriot, Lyon, France.'}, {'ForeName': 'Chirag', 'Initials': 'C', 'LastName': 'Patel', 'Affiliation': 'Division of Urology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Kassam', 'Affiliation': 'London Health Sciences Centre, University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Moore', 'Affiliation': 'University College London, London, England.'}, {'ForeName': 'Veeru', 'Initials': 'V', 'LastName': 'Kasivisvanathan', 'Affiliation': 'University College London, London, England.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Loblaw', 'Affiliation': 'Institute of Healthcare Policy and Management, Department of Radiation Oncology, Ontario Institute of Cancer Research, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Kebabdjian', 'Affiliation': 'Division of Urology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Craig C', 'Initials': 'CC', 'LastName': 'Earle', 'Affiliation': 'Ontario Institute of Cancer Research, Toronto, Ontario, Canada.'}, {'ForeName': 'Greg R', 'Initials': 'GR', 'LastName': 'Pond', 'Affiliation': 'Department of Biostatistics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Masoom A', 'Initials': 'MA', 'LastName': 'Haider', 'Affiliation': 'Toronto General Hospital, Department of Radiology, University of Toronto, Toronto, Ontario, Canada.'}]",JAMA oncology,['10.1001/jamaoncol.2020.7589'] 2091,33538761,"Povidone Iodine Mouthwash, Gargle, and Nasal Spray to Reduce Nasopharyngeal Viral Load in Patients With COVID-19: A Randomized Clinical Trial.",,2021,,['Patients With COVID-19'],"['Povidone Iodine Mouthwash, Gargle, and Nasal Spray']",['Nasopharyngeal Viral Load'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}]","[{'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}]",,0.132392,,"[{'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Guenezan', 'Affiliation': 'Emergency Department, University Hospital of Poitiers, Poitiers, France.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Garcia', 'Affiliation': 'Virology laboratory, University Hospital of Poitiers, Poitiers, France.'}, {'ForeName': 'Deidre', 'Initials': 'D', 'LastName': 'Strasters', 'Affiliation': 'Emergency Department, University Hospital of Poitiers, Poitiers, France.'}, {'ForeName': 'Clément', 'Initials': 'C', 'LastName': 'Jousselin', 'Affiliation': 'Virology laboratory, University Hospital of Poitiers, Poitiers, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Lévêque', 'Affiliation': 'Virology laboratory, University Hospital of Poitiers, Poitiers, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Frasca', 'Affiliation': 'Department of Anesthesia, Intensive Care and Perioperative Medicine, University Hospital of Poitiers, Poitiers, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Mimoz', 'Affiliation': 'Emergency Department, University Hospital of Poitiers, Poitiers, France.'}]",JAMA otolaryngology-- head & neck surgery,['10.1001/jamaoto.2020.5490'] 2092,33563735,Challenges in diabetic foot treatment during pandemic of COVID-19.,"OBJECTIVES To avoid hospital spread of Coronavirus-2019 (COVID-19) and to analyze out of hospital outcomes after amputation. METHODS Prospective analysis of data obtained from 60 diabetic patients in 2020 was performed at Cantonal Hospital Zenica, Zenica, Bosnia and Herzegovina. Personal protection equipment included double surgical mask, glasses, disposable surgical coats, and surgical masks for patients. Swabs were used to take samples from wounds. We randomly divided patients in 2 groups of 30 patients each. In pre-operative treatment, we used local anesthesia lidocaine hydrochloride 2% (Belupo, Koprivnica, Croatia) in group A and systemic analgesia intravenous tramadol chloride 100 mg intravenous (Krka, Novo Mesto, Slovenia) in group B. Wounds were surgically treated each day and heal spontaneously. Periodical control exams were performed. RESULTS Wound healing did not present any statistically significant differences between groups (group A: 69±21.97 and B: 61±22.13 days, t=-1.22; p =0.11). No statistically significant differences ( p <0.05) between groups A and B in wound healing regarding to gender or cigarette use was noted. CONCLUSION No significant differences in amputation treatment between the 2 comparative groups were noted. No confirmed COVID-19 infections in medical staff who performed surgical interventions or in treated patients were detected.",2021,"RESULTS Wound healing did not present any statistically significant differences between groups (group A:","['60 diabetic patients in 2020 was performed at Cantonal Hospital Zenica, Zenica, Bosnia and Herzegovina', 'patients']","['tramadol chloride 100\xa0mg intravenous (Krka, Novo Mesto, Slovenia', 'local anesthesia lidocaine hydrochloride 2% (Belupo, Koprivnica, Croatia']","['amputation treatment', 'Wound healing']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006036', 'cui_str': 'Bosnia - Herzegovnia'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0008203', 'cui_str': 'Chloride salt'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0037334', 'cui_str': 'Slovenia'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0546869', 'cui_str': 'Lidocaine hydrochloride'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}]","[{'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",,0.0188769,"RESULTS Wound healing did not present any statistically significant differences between groups (group A:","[{'ForeName': 'Haris', 'Initials': 'H', 'LastName': 'Vukas', 'Affiliation': 'From the Department of Vascular Surgery (Vukas), from the Department of Neurology (Kadić-Vukas), Cantonal Hospital Zenica, Zenica; from the Department of Vascular Surgery (Dragan Piljic), Cardiovascular Surgery Clinic, and from the Intensive Care (Dilista Piljic), University Clinical Center Tuzla, Clinic of Infective Disease, Tuzla, Bosnia and Herzegovina.'}, {'ForeName': 'Dragan', 'Initials': 'D', 'LastName': 'Piljic', 'Affiliation': 'From the Department of Vascular Surgery (Vukas), from the Department of Neurology (Kadić-Vukas), Cantonal Hospital Zenica, Zenica; from the Department of Vascular Surgery (Dragan Piljic), Cardiovascular Surgery Clinic, and from the Intensive Care (Dilista Piljic), University Clinical Center Tuzla, Clinic of Infective Disease, Tuzla, Bosnia and Herzegovina.'}, {'ForeName': 'Samra', 'Initials': 'S', 'LastName': 'Kadić-Vukas', 'Affiliation': 'From the Department of Vascular Surgery (Vukas), from the Department of Neurology (Kadić-Vukas), Cantonal Hospital Zenica, Zenica; from the Department of Vascular Surgery (Dragan Piljic), Cardiovascular Surgery Clinic, and from the Intensive Care (Dilista Piljic), University Clinical Center Tuzla, Clinic of Infective Disease, Tuzla, Bosnia and Herzegovina.'}, {'ForeName': 'Dilista', 'Initials': 'D', 'LastName': 'Piljic', 'Affiliation': 'From the Department of Vascular Surgery (Vukas), from the Department of Neurology (Kadić-Vukas), Cantonal Hospital Zenica, Zenica; from the Department of Vascular Surgery (Dragan Piljic), Cardiovascular Surgery Clinic, and from the Intensive Care (Dilista Piljic), University Clinical Center Tuzla, Clinic of Infective Disease, Tuzla, Bosnia and Herzegovina.'}]",Saudi medical journal,['10.15537/smj.2021.2.25687'] 2093,33561220,Walking Initiated 20 Minutes before the Time of Individual Postprandial Glucose Peak Reduces the Glucose Response in Young Men with Overweight or Obesity: A Randomized Crossover Study.,"BACKGROUND Although a single bout of postmeal exercise can lower postprandial glucose (PPG), its optimal timing remains unclear. OBJECTIVE This study aimed to investigate the effect of exercise timing using an individualized approach on PPG in overweight or obese young men. METHODS Twenty men [age: 23.0 ± 4.3 y; BMI (kg/m2): 27.4 ± 2.8] each completed three 240-min trials in a randomized order separated by 6-14 d: 1) sitting (SIT), 2) walking initiated at each participant's PPG-peak time (PPGP) (iP), and 3) walking initiated 20 min before the PPGP (20iP). For each participant, PPGP was predetermined using continuous glucose monitoring. Walking was performed at 50% maximal oxygen consumption for 30 min. Venous blood was collected at 15- and 30-min intervals for 0-120 min and 120-240 min, respectively. The primary outcome was plasma PPG. Generalized estimating equations were used for comparison between trials. RESULTS Compared with SIT, the 4-h incremental AUCs (iAUCs) for plasma PPG (-0.6 mmol · L-1 · h; P = 0.047) and insulin (-28.7%, P < 0.001) were reduced in 20iP only, and C-peptide concentrations were lower after iP (-14.9%, P = 0.001) and 20iP (-28.7%, P < 0.001). Plasma insulin (-11.1%, P = 0.006) and C-peptide (-8.3%, P = 0.012) were lower due to the 20iP compared with iP treatment. Finally, PPG reductions due to iP and 20iP occurred only in men with a BMI > 27.5 kg/m2 (iP, -11.2%; 20iP, -14.7%; P = 0.047) and higher glucose iAUC values during SIT (iP, -25.5%; 20iP, -25.7%; P < 0.001). CONCLUSIONS Walking initiated 20 min before PPGP lowered PPG and plasma insulin and C-peptide concentrations in young men with overweight or obesity, in particular in those with high BMI or glucose iAUC values during SIT; it also lowered plasma insulin and C-peptide concentrations more effectively than did exercise initiated at PPGP. This trial was registered at the Chinese Clinical Trial Registry (http://www.chictr.org.cn/index.aspx) as ChiCTR1900023175.",2021,"Plasma insulin (-11.1%, P = 0.006) and C-peptide (-8.3%, P = 0.012) were lower due to the 20iP compared with iP treatment.","['overweight or obese young men', 'Twenty men [age: 23.0\xa0±', 'Young Men with Overweight or Obesity', 'young men with overweight or obesity']","[""sitting (SIT), 2) walking initiated at each participant's PPG-peak time (PPGP) (iP), and 3) walking initiated 20\xa0min before the PPGP (20iP"", 'postmeal exercise']","['20iP only, and C-peptide concentrations', '4-h incremental AUCs (iAUCs) for plasma PPG', 'glucose iAUC values', 'Glucose Response', 'Venous blood', 'plasma PPG', 'Individual Postprandial Glucose Peak', 'Plasma insulin', 'PPG reductions due to iP and 20iP', 'PPG and plasma insulin and C-peptide concentrations']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0061969', 'cui_str': ""guanosine 5'-diphosphate-3'-monophosphate""}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",,0.116547,"Plasma insulin (-11.1%, P = 0.006) and C-peptide (-8.3%, P = 0.012) were lower due to the 20iP compared with iP treatment.","[{'ForeName': 'Xiaoyuan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Sports Science and Physical Education, Faculty of Education, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Waris', 'Initials': 'W', 'LastName': 'Wongpipit', 'Affiliation': 'Department of Sports Science and Physical Education, Faculty of Education, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Fenghua', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'Department of Health and Physical Education, The Education University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Sinead', 'Initials': 'S', 'LastName': 'Sheridan', 'Affiliation': 'Department of Sports Science and Physical Education, Faculty of Education, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Wendy Y J', 'Initials': 'WYJ', 'LastName': 'Huang', 'Affiliation': 'Department of Sport, Physical Education, and Health, Hong Kong Baptist University, Hong Kong, China.'}, {'ForeName': 'Cindy H P', 'Initials': 'CHP', 'LastName': 'Sit', 'Affiliation': 'Department of Sports Science and Physical Education, Faculty of Education, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Stephen H S', 'Initials': 'SHS', 'LastName': 'Wong', 'Affiliation': 'Department of Sports Science and Physical Education, Faculty of Education, The Chinese University of Hong Kong, Hong Kong, China.'}]",The Journal of nutrition,['10.1093/jn/nxaa420'] 2094,33561214,"Small-Quantity Lipid-Based Nutrient Supplements Do Not Affect Plasma or Milk Retinol Concentrations Among Malawian Mothers, or Plasma Retinol Concentrations among Young Malawian or Ghanaian Children in Two Randomized Trials.","BACKGROUND Vitamin A (VA) deficiency is prevalent in preschool-aged children in sub-Saharan Africa. OBJECTIVES We assessed the effect of small-quantity lipid-based nutrient supplements (SQ-LNS) given to women during pregnancy and lactation and their children from 6 to 18 mo of age on women's plasma and milk retinol concentrations in Malawi, and children's plasma retinol concentration in Malawi and Ghana. METHODS Pregnant women (≤20 wk of gestation) were randomized to receive daily: 1) iron and folic acid (IFA) during pregnancy only; 2) multiple micronutrients (MMN; 800 μg retinol equivalent (RE)/capsule), or 3) SQ-LNS (800 μg RE/20g) during pregnancy and the first 6 mo postpartum. Children of mothers in the SQ-LNS group received SQ-LNS (400 μg RE/20 g) from 6 to 18 mo of age; children of mothers in the IFA and MMN groups received no supplement. Plasma retinol was measured in mothers at ≤20 and 36 wk of gestation and 6 mo postpartum, and in children at 6 and 18 mo of age. Milk retinol was measured at 6 mo postpartum. VA status indicators were compared by group. RESULTS Among Malawian mothers, geometric mean (95% CI) plasma retinol concentrations at 36 wk of gestation and 6 mo postpartum were 0.97 μmol/L (0.94, 1.01 μmol/L) and 1.35 μmol/L (1.31, 1.39 μmol/L), respectively; geometric mean (95% CI) milk retinol concentration at 6 mo postpartum was 1.04 μmol/L (0.97, 1.13 μmol/L); results did not differ by intervention group. Geometric mean (95% CI) plasma retinol concentrations for Malawian children at 6 and 18 mo of age were 0.78 μmol/L (0.75, 0.81 μmol/L) and 0.81 μmol/L (0.78, 0.85 μmol/L), respectively, and for Ghanaian children they were 0.85 μmol/L (0.82, 0.88 μmol/L) and 0.88 μmol/L (0.85, 0.91 μmol/L), respectively; results did not differ by intervention group in either setting. CONCLUSIONS SQ-LNS had no effect on VA status of mothers or children, possibly because of low responsiveness of the VA status indicators.",2021,"CONCLUSIONS SQ-LNS had no effect on VA status of mothers or children, possibly because of low responsiveness of the VA status indicators.","[""women during pregnancy and lactation and their children from 6 to 18\xa0mo of age on women's plasma and milk retinol concentrations in Malawi, and children's plasma retinol concentration in Malawi and Ghana"", 'Pregnant women (≤20\xa0wk of gestation', 'preschool-aged children in sub-Saharan Africa']","['daily: 1) iron and folic acid (IFA) during pregnancy only; 2) multiple micronutrients (MMN; 800\xa0μg retinol equivalent (RE)/capsule), or 3) SQ-LNS', 'small-quantity lipid-based nutrient supplements (SQ-LNS', 'SQ-LNS']","['VA status', 'milk retinol concentration', 'Plasma retinol', 'plasma retinol concentrations', 'Plasma Retinol Concentrations', 'Plasma or Milk Retinol Concentrations', 'Geometric mean', 'Milk retinol']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017516', 'cui_str': 'Ghana'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0393847', 'cui_str': 'Motor neuropathy with multiple conduction block'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0556581', 'cui_str': 'Retinol equivalents'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.284722,"CONCLUSIONS SQ-LNS had no effect on VA status of mothers or children, possibly because of low responsiveness of the VA status indicators.","[{'ForeName': 'Marjorie J', 'Initials': 'MJ', 'LastName': 'Haskell', 'Affiliation': 'Institute for Global Nutrition, University of California, Davis, Davis, CA, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Young', 'Affiliation': 'Institute for Global Nutrition, University of California, Davis, Davis, CA, USA.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Adu-Afaruwah', 'Affiliation': 'Department of Nutrition and Food Science, University of Ghana, Accra, Ghana.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lartey', 'Affiliation': 'Department of Nutrition and Food Science, University of Ghana, Accra, Ghana.'}, {'ForeName': 'Harriet Eyram Teiko', 'Initials': 'HET', 'LastName': 'Okronipa', 'Affiliation': 'Institute for Global Nutrition, University of California, Davis, Davis, CA, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Maleta', 'Affiliation': 'Department of Public Health, Blantyre, School of Public Health and Family Medicine, College of Medicine, University of Malawi, Malawi.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Ashorn', 'Affiliation': 'Center for Child Health Research, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Josh M', 'Initials': 'JM', 'LastName': 'Jorgensen', 'Affiliation': 'Institute for Global Nutrition, University of California, Davis, Davis, CA, USA.'}, {'ForeName': 'Yue-Mei', 'Initials': 'YM', 'LastName': 'Fan', 'Affiliation': 'Center for Child Health Research, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Arnold', 'Affiliation': 'Institute for Global Nutrition, University of California, Davis, Davis, CA, USA.'}, {'ForeName': 'Lindsay H', 'Initials': 'LH', 'LastName': 'Allen', 'Affiliation': 'Institute for Global Nutrition, University of California, Davis, Davis, CA, USA.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ashorn', 'Affiliation': 'Center for Child Health Research, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Kathryn G', 'Initials': 'KG', 'LastName': 'Dewey', 'Affiliation': 'Institute for Global Nutrition, University of California, Davis, Davis, CA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa439'] 2095,33571369,Adequacy of Nutrient Intakes of Severely and Acutely Malnourished Children Treated with Different Doses of Ready-To-Use Therapeutic Food in Burkina Faso.,"BACKGROUND Ready-to-use therapeutic foods (RUTF) are designed to cover the daily nutrient requirements of children with severe acute malnutrition (SAM). However, with the transfer of uncomplicated SAM care from the hospital environment to the community level, children will be able to consume complementary and family foods (CFF) in addition to RUTF, and this might decrease the quantity of RUTF needed for recovery. OBJECTIVES Using an individually randomized clinical trial, we investigated the effects of a reduced RUTF dose on the daily energy and macronutrient intakes, the proportion of energy coming from CFF, and the mean probability of adequacy (MPA) of intake in 11 micronutrients of 516 children aged 6-59 mo who were treated for SAM in Burkina Faso. METHODS The data were collected using a single 24-h multipass dietary recall, 1 mo after starting treatment, from December 2016 to August 2018, repeated on a subsample of 66 children. Differences between children receiving the reduced RUTF (intervention arm) and those receiving standard RUTF (control arm) were assessed by linear mixed models. RESULTS Daily energy intake was lower (P < 0.01) in the intervention arm (mean ± SD 1321 ± 339 kcal) than in the control arm (1467 ± 319 kcal). CFF contributed to 40% of the daily energy intake in the intervention and 35% in the control arm. The MPA for 11 micronutrients was 0.89 ± 0.1 in the intervention arm and 0.95 ± 0.07 in the control arm (P = 0.06). CONCLUSIONS Reducing the dose of RUTF during SAM treatment had a negative impact on daily energy intake of the children. Despite this, children covered their recommended energy intake. The energy intake coming from CFF was similar between arms, suggesting that children's feeding practices did not change due to the reduction in RUTF in this context. This trial was registered at the IRSCTN registry as ISRCTN50039021.",2021,"RESULTS Daily energy intake was lower (P < 0.01) in the intervention arm (mean ± SD 1321 ± 339 kcal) than in the control arm (1467 ± 319 kcal).","['11 micronutrients of 516 children aged 6-59 mo who were treated for SAM in Burkina Faso.\nMETHODS\n\n\nThe data were collected using a single 24-h multipass dietary recall, 1 mo after starting treatment, from December 2016 to August 2018, repeated on a subsample of 66 children', 'children with severe acute malnutrition (SAM', 'Malnourished Children', 'Severely and Acutely']","['reduced RUTF', 'RUTF']","['CFF', 'daily energy intake', 'Daily energy intake']","[{'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}, {'cui': 'C0006409', 'cui_str': 'Burkina Faso'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]","[{'cui': 'C0453818', 'cui_str': 'Family food'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",516.0,0.0780283,"RESULTS Daily energy intake was lower (P < 0.01) in the intervention arm (mean ± SD 1321 ± 339 kcal) than in the control arm (1467 ± 319 kcal).","[{'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Nikièma', 'Affiliation': 'Nutrition and Health Department, Action contre la Faim, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Suvi T', 'Initials': 'ST', 'LastName': 'Kangas', 'Affiliation': 'Expertise and Advocacy Department, Action contre la Faim, Paris, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Salpéteur', 'Affiliation': 'Expertise and Advocacy Department, Action contre la Faim, Paris, France.'}, {'ForeName': 'Abdoulaye', 'Initials': 'A', 'LastName': 'Ouédraogo', 'Affiliation': 'Food Security and Livelihoods Department, Action contre la Faim, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Lachat', 'Affiliation': 'Department of Food Technology, Safety, and Health, Faculty of Bioscience Engineering, Ghent University, Belgium.'}, {'ForeName': 'Nestor H I', 'Initials': 'NHI', 'LastName': 'Bassolé', 'Affiliation': 'Department of Biochemistry and microbiology, Joseph KI-ZERBO University, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Nadia F', 'Initials': 'NF', 'LastName': 'Fogny', 'Affiliation': 'School of Nutrition and Food Sciences and Technologies, Faculty of Agronomic Sciences, University of Abomey-Calavi, Benin.'}]",The Journal of nutrition,['10.1093/jn/nxaa393'] 2096,33579336,Isometric blood flow restriction exercise: acute physiological and neuromuscular responses.,"BACKGROUND Numerous studies have demonstrated that the addition of blood flow restriction (BFR) to low-load (LL) resistance exercise leads to elevated levels of muscle hypertrophy and strength gains. In terms of main underlying mechanisms, metabolic accumulation and increased neuromuscular adaptations seem to play a primary role. However, this evidence is largely based on dynamic exercise conditions. Therefore, the main objective was to investigate the acute physiological adaptations following isometric LL-BFR exercise. METHODS Fifteen males participated in this cross-over trial and completed the following sessions in a random and counterbalanced order: isometric LL-BFR exercise (20% maximum voluntary contraction, MVC) and load matched LL exercise without BFR. Lactate levels, muscle activation as well as muscle swelling were recorded during the whole exercise and until 15 min post completion. Additionally, changes in maximal voluntary torque and ratings of perceived exertion (RPE) were monitored. RESULTS During exercise, EMG amplitudes (72.5 ± 12.7% vs. 46.3 ± 6.7% of maximal EMG activity), muscle swelling and RPE were significantly higher during LL-BFR compared to LL (p < 0.05). Lactate levels did not show significant group differences during exercise but revealed higher increases 15 min after completion in the LL-BFR condition (LL-BFR: + 69%, LL: + 22%) (p < 0.05). Additionally, MVC torque significantly decreased immediately post exercise only in LL-BFR (~ - 11%) (p < 0.05) but recovered after 15 min. CONCLUSIONS The present results demonstrate that isometric LL-BFR causes increased metabolic, neuromuscular as well as perceptual responses compared to LL alone. These adaptations are similar to dynamic exercise and therefore LL-BFR represents a valuable type of exercise where large joint movements are contraindicated (e.g. rehabilitation after orthopedic injuries).",2021,"Lactate levels did not show significant group differences during exercise but revealed higher increases 15 min after completion in the LL-BFR condition (LL-BFR: + 69%, LL: + 22%) (p < 0.05).",['Fifteen males participated in this cross-over trial and completed the following sessions in a random and counterbalanced order'],"['isometric LL-BFR exercise (20% maximum voluntary contraction, MVC) and load matched LL exercise without BFR', 'isometric LL-BFR exercise', 'Isometric blood flow restriction exercise']","['maximal voluntary torque and ratings of perceived exertion (RPE', 'MVC torque', 'Lactate levels', 'LL-BFR', 'maximal EMG activity), muscle swelling and RPE', 'Lactate levels, muscle activation as well as muscle swelling']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4284072', 'cui_str': 'Order document'}]","[{'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0281913', 'cui_str': 'Swelling of skeletal muscle'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",15.0,0.0420079,"Lactate levels did not show significant group differences during exercise but revealed higher increases 15 min after completion in the LL-BFR condition (LL-BFR: + 69%, LL: + 22%) (p < 0.05).","[{'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Lauber', 'Affiliation': 'Department of Neurosciences and Movement Sciences, University of Fribourg, Fribourg, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'König', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Schwarzwaldstraße 175, 79117, Freiburg, Germany.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Gollhofer', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Schwarzwaldstraße 175, 79117, Freiburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Centner', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Schwarzwaldstraße 175, 79117, Freiburg, Germany. christoph.centner@sport.uni-freiburg.de.'}]","BMC sports science, medicine & rehabilitation",['10.1186/s13102-021-00239-7'] 2097,33577388,Photon-Induced Photoacoustic Streaming Activation of the Postbleaching Antioxidant Application Rapidly Improves Bonding to Pulp Chamber Dentin.,"Objective: This study explored whether the erbium/yttrium/aluminum/garnet (Er:YAG) laser irradiated through the photon-induced photoacoustic streaming (PIPS) method would impact on the resin bonding to pulp chamber dentin when used to activate bleaching and/or postbleaching antioxidant treatment. Materials and methods: One hundred five dentin samples prepared from freshly extracted human incisors were randomly assigned to seven groups ( n  = 15): control (no bleaching/antioxidant); CB (conventional bleaching only); MB (modified bleaching only); CB-NI (conventional bleaching+antioxidant with needle irrigation); MB-NI (modified bleaching+antioxidant with needle irrigation); CB-PIPSI (conventional bleaching+antioxidant with PIPS-activated irrigation); and MB-PIPSI (modified bleaching+antioxidant with PIPS-activated irrigation). Bleaching (40% hydrogen peroxide) lasted for 20 min. Modified bleaching groups were irradiated with Er:YAG laser using the PIPS tip (2940 nm, 0.90 W, 30 Hz, 30 mJ/pulse, 50-μsec pulse duration) during the first 60 sec of the procedure. The antioxidant treatment with 10% sodium ascorbate lasted for 60 sec. PIPS-activated antioxidant groups were irradiated with Er:YAG laser using the PIPS tip (2940 nm, 0.30 W, 15 Hz, 20 mJ per pulse, 50-μsec pulse duration) throughout the procedure. After completing the composite restorations, all samples were subjected to 5000 thermocycling and the shear bond strength (SBS) test at a crosshead speed of 1 mm/min. SBS data were analyzed using the Kruskal-Wallis test with Bonferroni correction (α& 0.05). Results: No significant difference was detected among the control, CB-PIPSI, and MB-PIPSI ( p  > 0.05), which presented a significantly higher SBS compared with the other groups ( p  < 0.05). Conclusions: Irrespective of the application mode of the initial bleaching, PIPS-activated irrigation of the antioxidant improved SBS to bleached dentin to the level of the control in 1 min. Postbleaching antioxidant treatment combined with the PIPS method might be a promising approach to enable immediate resin restoration of bleached dentin.",2021,"No significant difference was detected among the control, CB-PIPSI, and MB-PIPSI ( p  > 0.05), which presented a significantly higher SBS compared with the other groups ( p  < 0.05). ",['One hundred five dentin samples prepared from freshly extracted human incisors'],"['erbium/yttrium/aluminum/garnet (Er:YAG) laser irradiated through the photon-induced photoacoustic streaming (PIPS', 'Postbleaching Antioxidant Application', 'control (no bleaching/antioxidant); CB (conventional bleaching only); MB (modified bleaching only); CB-NI (conventional bleaching+antioxidant with needle irrigation); MB-NI (modified bleaching+antioxidant with needle irrigation); CB-PIPSI (conventional bleaching+antioxidant with PIPS-activated irrigation); and MB-PIPSI ', 'sodium ascorbate', 'Bleaching (40% hydrogen peroxide', 'modified bleaching+antioxidant with PIPS-activated irrigation', 'PIPS-activated antioxidant groups were irradiated with Er:YAG laser using the PIPS tip', 'Modified bleaching groups were irradiated with Er:YAG laser using the PIPS tip']","['control, CB-PIPSI, and MB-PIPSI', 'SBS data', 'shear bond strength (SBS) test', 'SBS']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}]","[{'cui': 'C0014688', 'cui_str': 'Erbium'}, {'cui': 'C0043432', 'cui_str': 'Yttrium'}, {'cui': 'C0002367', 'cui_str': 'Aluminum'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C1277077', 'cui_str': 'Irradiated blood product'}, {'cui': 'C0086805', 'cui_str': 'Photon'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0887557', 'cui_str': 'Sodium Ascorbate'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0457903', 'cui_str': 'Erbium:YAG laser device'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003380', 'cui_str': 'Antimony'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0226614,"No significant difference was detected among the control, CB-PIPSI, and MB-PIPSI ( p  > 0.05), which presented a significantly higher SBS compared with the other groups ( p  < 0.05). ","[{'ForeName': 'Nasibe Aycan', 'Initials': 'NA', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Restorative Dentistry and Faculty of Dentistry, Aydın Adnan Menderes University, Aydın, Turkey.'}, {'ForeName': 'Hicran', 'Initials': 'H', 'LastName': 'Dönmez Özkan', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Aydın Adnan Menderes University, Aydın, Turkey.'}]","Photobiomodulation, photomedicine, and laser surgery",['10.1089/photob.2020.4949'] 2098,33541567,"A 6-month, double-blind, placebo-controlled, randomized trial to evaluate the effect of Eurycoma longifolia (Tongkat Ali) and concurrent training on erectile function and testosterone levels in androgen deficiency of aging males (ADAM).","BACKGROUND Androgen deficiency of aging males (ADAM) largely manifests as sexual symptoms. Erectile dysfunction is one of the most common symptoms of ADAM. AIM To ascertain the effect of concurrent training and supplementation with Eurycoma longifolia on erectile function and testosterone levels in men with ADAM, and the association of erectile function with levels of total testosterone. METHODS 6-month, randomized, double-blind, placebo-controlled four-arm clinical. 45 men (47.38 ± 5.03 years) were randomized into 4 groups (G1: control + placebo; G2: control + Eurycoma longifolia; G3: concurrent training + placebo; G4: concurrent training + Eurycoma longifolia). 22 received a 200 mg supplement of Eurycoma longifolia and 23 underwent the intervention with concurrent training, 3 times a week for 60 min at progressive intensity. OUTCOMES International Index of Erectile Function (IIEF-5), Aging Male Scale (AMS) and total testosterone. RESULTS Erectile function demonstrated improvements in both interventions; however, the most significant results were obtained by men allocated to concurrent training + Eurycoma longifolia. CLINICAL IMPLICATIONS A 200 mg supplement of Eurycoma longifolia and the practice of concurrent training for 6 months significantly improved the erectile function of men with ADAM. STRENGTHS & LIMITATIONS The study's design stands out as a strength, in addition to the six-month intervention. The main limitation is the study not having groups that used only Eurycoma longifolia and only concurrent training. CONCLUSION The combination of Eurycoma longifolia and concurrent training improved erectile function and increased total testosterone levels in men with ADAM.",2021,The combination of Eurycoma longifolia and concurrent training improved erectile function and increased total testosterone levels in men with ADAM.,"['men with ADAM', '45 men (47.38 ± 5.03 years', 'androgen deficiency of aging males (ADAM']","['placebo', 'Eurycoma longifolia and concurrent training', 'control + placebo; G2: control + Eurycoma longifolia; G3: concurrent training + placebo; G4: concurrent training + Eurycoma longifolia', 'Eurycoma longifolia', 'Eurycoma longifolia (Tongkat Ali) and concurrent training', 'concurrent training and supplementation with Eurycoma longifolia']","['International Index of Erectile Function (IIEF-5), Aging Male Scale (AMS) and total testosterone', 'total testosterone levels', 'erectile function', 'Erectile dysfunction', 'erectile function and testosterone levels']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0342527', 'cui_str': 'Deficiency of testosterone biosynthesis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1258070', 'cui_str': 'Long Jack'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1258069', 'cui_str': 'Tongkat Ali'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0202227', 'cui_str': 'Testosterone measurement, total'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}]",,0.172957,The combination of Eurycoma longifolia and concurrent training improved erectile function and increased total testosterone levels in men with ADAM.,"[{'ForeName': 'Alice Erwig', 'Initials': 'AE', 'LastName': 'Leitão', 'Affiliation': 'University of Santa Catarina State, Universidade do Estado de Santa Catarina Florianopolis, Santa Catarina, Brazil. Electronic address: aliceerwig@gmail.com.'}, {'ForeName': 'Melissa Carvalho de Souza', 'Initials': 'MCS', 'LastName': 'Vieira', 'Affiliation': 'University of Santa Catarina State, Universidade do Estado de Santa Catarina Florianopolis, Santa Catarina, Brazil.'}, {'ForeName': 'Andreia', 'Initials': 'A', 'LastName': 'Pelegrini', 'Affiliation': 'University of Santa Catarina State, Universidade do Estado de Santa Catarina Florianopolis, Santa Catarina, Brazil.'}, {'ForeName': 'Edson Luiz', 'Initials': 'EL', 'LastName': 'da Silva', 'Affiliation': 'Federal University of Santa Catarina, Universidade Federal de Santa Catarina, Brazil.'}, {'ForeName': 'Adriana Coutinho de Azevedo', 'Initials': 'ACA', 'LastName': 'Guimarães', 'Affiliation': 'University of Santa Catarina State, Universidade do Estado de Santa Catarina Florianopolis, Santa Catarina, Brazil.'}]",Maturitas,['10.1016/j.maturitas.2020.12.002'] 2099,33545411,Comparison of two automated sperm analyzers using 2 different detection methods versus manual semen assessment.,"PURPOSE The exploration of male infertility is mainly based on semen analysis, but its evaluation might be affected by the operator's competence and subjectivity. This led to the development of automated semen analyzing systems. Despite continuous improvement, the precision and correlation of these automated systems with manual sperm assessment performed strictly according to WHO guidelines remains variable in the literature, and their role in daily practice is debated. METHODS In this double blind prospective study, we compared the results provided by 2 automated systems based on different concepts (CASA and electro-optical signal) with manual sperm assessment. Sperm concentration, motility and morphology were performed simultaneously and independently by different operators, blinded to each other. RESULTS A total of 102 unselected men attending the andrology department for routine sperm analysis were included in the study. We found no significant difference between each automated method and manual assessment for all sperm parameters, except for sperm morphology assessment where the electro-optical system gave higher results and performed slightly poorer than CASA. Correlation was moderate to high between manual assessment and each automated methods for all sperm parameters, with randomly distributed differences. CONCLUSIONS Overall, these results show that both types of automated systems can be implemented in andrology laboratory for routine sperm analysis.",2021,"We found no significant difference between each automated method and manual assessment for all sperm parameters, except for sperm morphology assessment where the electro-optical system gave higher results and performed slightly poorer than CASA.",['102 unselected men attending the andrology department for routine sperm analysis were included in the study'],[],"['Sperm concentration, motility and morphology']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0085806', 'cui_str': 'Andrology'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0430988', 'cui_str': 'Sperm examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0429845', 'cui_str': 'Sperm concentration measurement'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}]",102.0,0.0581372,"We found no significant difference between each automated method and manual assessment for all sperm parameters, except for sperm morphology assessment where the electro-optical system gave higher results and performed slightly poorer than CASA.","[{'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Lammers', 'Affiliation': 'CHU Nantes, Nantes Université, Service de biologie et médecine de la reproduction, Nantes, France; Nantes Université, Inserm, Centre de Recherche en Transplantation et Immunologie, UMR 1064, ITUN, Nantes, France.'}, {'ForeName': 'Sana', 'Initials': 'S', 'LastName': 'Chtourou', 'Affiliation': 'CHU Nantes, Nantes Université, Service de biologie et médecine de la reproduction, Nantes, France; Laboratoire de biologie de la reproduction et de cytogénétique, Hôpital Aziza Othmana, Tunis, Tunisia.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Reignier', 'Affiliation': 'CHU Nantes, Nantes Université, Service de biologie et médecine de la reproduction, Nantes, France; Nantes Université, Inserm, Centre de Recherche en Transplantation et Immunologie, UMR 1064, ITUN, Nantes, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Loubersac', 'Affiliation': 'CHU Nantes, Nantes Université, Service de biologie et médecine de la reproduction, Nantes, France; Nantes Université, Inserm, Centre de Recherche en Transplantation et Immunologie, UMR 1064, ITUN, Nantes, France.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Barrière', 'Affiliation': 'CHU Nantes, Nantes Université, Service de biologie et médecine de la reproduction, Nantes, France; Nantes Université, Inserm, Centre de Recherche en Transplantation et Immunologie, UMR 1064, ITUN, Nantes, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Fréour', 'Affiliation': 'CHU Nantes, Nantes Université, Service de biologie et médecine de la reproduction, Nantes, France; Nantes Université, Inserm, Centre de Recherche en Transplantation et Immunologie, UMR 1064, ITUN, Nantes, France. Electronic address: thomas.freour@chu-nantes.fr.'}]",Journal of gynecology obstetrics and human reproduction,['10.1016/j.jogoh.2021.102084'] 2100,33545336,"Benzoyl peroxide treatment decreases Cutibacterium acnes in shoulder surgery, from skin incision until wound closure.","INTRODUCTION Most surgical site infections after shoulder surgery are caused by Cutibacterium acnes. Topically applied benzoyl peroxide (BPO) has for years been used to decrease the skin load of C acnes in treatment of acne vulgaris. The purpose of this study was to examine this effect on bacterial colonization in patients subjected to elective shoulder surgery at different stages of the procedure. METHODS A total of 100 patients scheduled for primary elective open shoulder surgery were randomized to prepare either with BPO or according to local guidelines-with soap (control group). Four skin swabs were taken in a standardized manner at different times, before and after surgical skin preparation, 1 in dermis, and finally after the skin was sutured. Before skin incision, 5 punch biopsies (3 mm in diameter and maximum 4 mm deep) were retrieved spaced 2 cm apart in the planned skin incision. On culturing, quantification of C acnes was made by serial dilutions. RESULTS Men had a 5-fold higher amount of C acnes on untreated skin. Treatment with BPO considerably lowered this count (P = .0001) both before and after skin disinfection compared to the control group. This positive effect of BPO persisted until skin closure, the point at which some recolonization of C acnes had occurred, but to a higher degree in the control group (P = .040). CONCLUSION Preoperative BPO treatment of the shoulder may be an effective method to decrease bacterial skin load of C acnes from skin incision until wound closure.",2021,Treatment with BPO considerably lowered this count (p=0.0001) both before and after skin disinfection compared to the control group.,"['100 patients scheduled for primary elective open shoulder surgery', 'patients subjected to elective shoulder surgery at different stages of the procedure']","['BPO or according to local guidelines: with soap (control group', 'benzoyl peroxide (BPO', 'Benzoyl peroxide']",[],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0186321', 'cui_str': 'Operative procedure on shoulder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0005088', 'cui_str': 'Benzoyl Peroxide'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],100.0,0.0254559,Treatment with BPO considerably lowered this count (p=0.0001) both before and after skin disinfection compared to the control group.,"[{'ForeName': 'Vendela M', 'Initials': 'VM', 'LastName': 'Scheer', 'Affiliation': 'Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden. Electronic address: vendela.scheer@liu.se.'}, {'ForeName': 'Malin Bergman', 'Initials': 'MB', 'LastName': 'Jungeström', 'Affiliation': 'Faculty of Health Sciences, University Hospital, Linköping, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Serrander', 'Affiliation': 'Division of Clinical Microbiology, Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Kalén', 'Affiliation': 'Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden; Department of Orthopedics, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Johan H', 'Initials': 'JH', 'LastName': 'Scheer', 'Affiliation': 'Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden; Department of Orthopedics, Linköping University, Linköping, Sweden.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2020.12.019'] 2101,33547510,"Invited Discussion on: ""Effect on Tumescent Lidocaine and Epinephrine Infiltration on Blood Loss in Inferior Pedicle Wise-Pattern Breast Reduction: A Prospective Randomized Study"".",,2021,,['Inferior Pedicle Wise-Pattern Breast Reduction'],['Lidocaine and Epinephrine Infiltration'],['Blood Loss'],"[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0456605', 'cui_str': 'Pedicle'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0191922', 'cui_str': 'Reduction mammoplasty'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",,0.0157658,,"[{'ForeName': 'Dana Mihaela', 'Initials': 'DM', 'LastName': 'Jianu', 'Affiliation': 'ProEstetica Medical Center, str. Paris 40 A, sector 1, 011817, Bucharest, Romania. djianu02@gmail.com.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01943-4'] 2102,33550193,"The effect of rosemary essential oil inhalation on sleepiness and alertness of shift-working nurses: A randomized, controlled field trial.","BACKGROUND Sleepiness during the night shift is a common complaint of shift workers, including the nurses. This study investigated the effects of inhaled rosemary oil on sleepiness and alertness of shift-working nurses. METHODS Eighty shift-working nurses were selected and assigned randomly into control (n = 40) and intervention (n = 40) groups. Both groups completed the Karolinska Sleep Questionnaire and Epworth Sleepiness Survey before the intervention. The intervention group received one drop of rosemary essential oil using a mask. The control group received a drop of distilled water instead, after which the questionnaires were completed for a second time. RESULTS The sleepiness mean score in the intervention group reduced from 12.15 to 8.3, while it increased from 11.41 to 13.76 in the control group (P < 0.001). The alertness mean scores changed from 4.45 to 3.25 and from 4.41 to 5.34 in intervention and control groups, respectively (P < 0.001). CONCLUSION Rosemary aroma decreased sleepiness and increased alertness in shift-working nurses.",2021,"The alertness mean scores changed from 4.45 to 3.25 and from 4.41 to 5.34 in intervention and control groups, respectively (P < 0.001). ","['sleepiness and alertness of shift-working nurses', 'Eighty shift-working nurses', 'n\xa0=\xa040) and intervention (n\xa0=\xa040']","['Rosemary aroma', 'rosemary essential oil using a mask', 'rosemary essential oil inhalation', 'inhaled rosemary oil']","['sleepiness mean score', 'Karolinska Sleep Questionnaire and Epworth Sleepiness Survey', 'alertness mean scores', 'sleepiness and increased alertness']","[{'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0425104', 'cui_str': 'Shift worker'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0939869', 'cui_str': 'rosemary extract'}, {'cui': 'C2987717', 'cui_str': 'Scents'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0304114', 'cui_str': 'rosemary oil'}]","[{'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",80.0,0.0394962,"The alertness mean scores changed from 4.45 to 3.25 and from 4.41 to 5.34 in intervention and control groups, respectively (P < 0.001). ","[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Nasiri', 'Affiliation': 'Medical Toxicology and Drug Abuse Research Center (MTDRC), Birjand University of Medical Sciences, Birjand, Iran. Electronic address: nasiri2006@bums.ac.ir.'}, {'ForeName': ""Masoomeh Mo'tamed"", 'Initials': 'MM', 'LastName': 'Boroomand', 'Affiliation': 'MScN, Department of Nursing, Nursing and Midwifery Faculty, Birjand University of Medical Sciences, Birjand, Iran. Electronic address: motamed@bums.ac.ir.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101326'] 2103,33549526,Comparison of Outcomes and Mortality in Patients Having Left Ventricular Assist Device Implanted Early -vs- Late After Diagnosis of Cardiomyopathy.,"LVAD implantation in patients with a recently diagnosed cardiomyopathy has been poorly investigated. This work aims at describing the characteristics and outcomes of patients receiving a LVAD within 30 days following the diagnosis of cardiomyopathy. Patients from the ASSIST-ICD study was divided into recently and remotely diagnosed cardiomyopathy based on the time from initial diagnosis of cardiomyopathy to LVAD implantation using the cut point of 30 days. The primary end point of the study was all-cause mortality at 30-day and during follow-up. A total of 652 patients were included and followed during a median time of 9.1 (2.5 to 22.1) months. In this population, 117 (17.9%) had a recently diagnosed cardiomyopathy and had LVAD implantation after a median time of 15.0 (9.0 to 24.0) days following the diagnosis. This group of patients was significantly younger, with more ischemic cardiomyopathy, more sudden cardiac arrest (SCA) events at the time of the diagnosis and were more likely to receive temporary mechanical support before LVAD compared with the remotely diagnosed group. Postoperative in-hospital survival was similar in groups, but recently diagnosed patients had a better long-term survival after hospital discharge. SCA before LVAD and any cardiac surgery combined with LVAD implantation were identified as 2 independent predictors of postoperative mortality in recently diagnosed patients. In conclusion, rescue LVAD implantation for recently diagnosed severe cardiomyopathy is common in clinical practice. Such patients experience a relatively low postoperative mortality and have a better long-term survival compared with remotely diagnosed patients.",2021,"Post-operative in-hospital survival was similar among groups, but recently diagnosed patients had a better long-term survival after hospital discharge.","['Patients from the ASSIST-ICD study were divided into recently and remotely diagnosed cardiomyopathy based on the time from initial diagnosis of cardiomyopathy to LVAD implantation using the cut point of 30 days', 'Patients', 'A total of 652 patients were included and followed during a median time of 9.1 (2.5-22.1) months', 'patients receiving a LVAD within 30 days following the diagnosis of cardiomyopathy', 'patients with a recently diagnosed cardiomyopathy']","['LVAD implantation', 'Having Left Ventricular Assist Device Implanted Early -vs']","['LVAD implantation', 'Post-operative in-hospital survival', 'Late', 'sudden cardiac arrest (SCA) events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0020725', 'cui_str': 'I-cell disease'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C1720824', 'cui_str': 'Cardiac Arrest, Sudden'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",652.0,0.0797811,"Post-operative in-hospital survival was similar among groups, but recently diagnosed patients had a better long-term survival after hospital discharge.","[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Chen', 'Affiliation': 'Univ Rennes, CHU Rennes, INSERM, LTSI - UMR 1099, Rennes, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Nesseler', 'Affiliation': 'Univ Rennes, CHU Rennes, INSERM, LTSI - UMR 1099, Rennes, France.'}, {'ForeName': 'Raphaël P', 'Initials': 'RP', 'LastName': 'Martins', 'Affiliation': 'Univ Rennes, CHU Rennes, INSERM, LTSI - UMR 1099, Rennes, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Goéminne', 'Affiliation': 'CHU Lille, Institut Coeur-Poumons, Cardiac Intensive Care Unit, Department of Cardiology, Department of Cardiac Surgery, Lille, France.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Vincentelli', 'Affiliation': 'CHU Lille, Institut Coeur-Poumons, Cardiac Intensive Care Unit, Department of Cardiology, Department of Cardiac Surgery, Lille, France.'}, {'ForeName': 'Clément', 'Initials': 'C', 'LastName': 'Delmas', 'Affiliation': 'Centre Hospitalier Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Porterie', 'Affiliation': 'Centre Hospitalier Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Nubret', 'Affiliation': 'Hôpital Cardiologique du Haut-Lévêque, LIRYC institute, Université Bordeaux, Bordeaux, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Pernot', 'Affiliation': 'Hôpital Cardiologique du Haut-Lévêque, LIRYC institute, Université Bordeaux, Bordeaux, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Kindo', 'Affiliation': 'Département de chirurgie cardiovasculaire, hôpitaux universitaires de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Tam', 'Initials': 'T', 'LastName': 'Hoang Minh', 'Affiliation': 'Département de chirurgie cardiovasculaire, hôpitaux universitaires de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gaudard', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, PhyMedExp, University of Montpellier, INSERM, CNRS, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Rouvière', 'Affiliation': 'Department of Cardiac Surgery, Anesthesiology and Critical Care Medicine, Arnaud de Villeneuve Hospital, CHRU Montpellier, Montpellier, France.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Michel', 'Affiliation': 'Department of Cardiology and Heart Transplantation Unit, CHU Nantes, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Sénage', 'Affiliation': 'Department of Cardiology and Heart Transplantation Unit, CHU Nantes, France.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Boignard', 'Affiliation': 'Department of Cardiology and Cardiovascular Surgery, CHU Michallon, Grenoble, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Chavanon', 'Affiliation': 'Department of Cardiology and Cardiovascular Surgery, CHU Michallon, Grenoble, France.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Verdonk', 'Affiliation': 'Department of Cardiology and cardiac surgery, Bichat-Hospital, Paris, France.'}, {'ForeName': 'Marylou', 'Initials': 'M', 'LastName': 'Para', 'Affiliation': 'Department of Cardiology and cardiac surgery, Bichat-Hospital, Paris, France.'}, {'ForeName': 'Edeline', 'Initials': 'E', 'LastName': 'Pelcé', 'Affiliation': 'Department of Cardiac Surgery, La Timone Hospital, Marseille, France.'}, {'ForeName': 'Vlad', 'Initials': 'V', 'LastName': 'Gariboldi', 'Affiliation': 'Department of Cardiac Surgery, La Timone Hospital, Marseille, France.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Pozzi', 'Affiliation': 'Department of Cardiac Surgery, ""Louis Pradel"" Cardiologic Hospital, Lyon, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Baudry', 'Affiliation': 'Department of Cardiac Surgery, ""Louis Pradel"" Cardiologic Hospital, Lyon, France.'}, {'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Litzler', 'Affiliation': 'Department of Cardiology and Cardiovascular Surgery, Hospital Charles Nicolle, Rouen, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Anselme', 'Affiliation': 'Department of Cardiology and Cardiovascular Surgery, Hospital Charles Nicolle, Rouen, France.'}, {'ForeName': 'Katrien', 'Initials': 'K', 'LastName': 'Blanchart', 'Affiliation': 'Department of Cardiology and Cardiac Surgery, University of Caen and University Hospital of Caen, France.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Babatasi', 'Affiliation': 'Department of Cardiology and Cardiac Surgery, University of Caen and University Hospital of Caen, France.'}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Garnier', 'Affiliation': 'Department of Cardiology and cardiac surgery, University Hospital, Dijon, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Bielefeld', 'Affiliation': 'Department of Cardiology and cardiac surgery, University Hospital, Dijon, France.'}, {'ForeName': 'Costin', 'Initials': 'C', 'LastName': 'Radu', 'Affiliation': 'Department of Cardiology and Cardiac Surgery, AP-HP CHU Henri Mondor, Créteil, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Lellouche', 'Affiliation': 'Department of Cardiology and Cardiac Surgery, AP-HP CHU Henri Mondor, Créteil, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Bourguignon', 'Affiliation': 'Department of Cardiology and Cardiac Surgery, Tours University Hospital, Tours, France.'}, {'ForeName': 'Thibaud', 'Initials': 'T', 'LastName': 'Genet', 'Affiliation': 'Department of Cardiology and Cardiac Surgery, Tours University Hospital, Tours, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Eschalier', 'Affiliation': 'CHU Clermont-Ferrand, Cardiology Department, Clermont-Ferrand, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': ""D'Ostrevy"", 'Affiliation': 'CHU Clermont-Ferrand, Cardiology Department, Clermont-Ferrand, France.'}, {'ForeName': 'Marie-Cécile', 'Initials': 'MC', 'LastName': 'Bories', 'Affiliation': 'European Georges Pompidou Hospital, Cardiology Department, Paris, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Baudinaud', 'Affiliation': 'European Georges Pompidou Hospital, Cardiology Department, Paris, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Vanhuyse', 'Affiliation': 'Department of Cardiology and Cardiac Surgery, CHU de Nancy, Hopital de Brabois, Nancy, France.'}, {'ForeName': 'Hugues', 'Initials': 'H', 'LastName': 'Blangy', 'Affiliation': 'Department of Cardiology and Cardiac Surgery, CHU de Nancy, Hopital de Brabois, Nancy, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Leclercq', 'Affiliation': 'Univ Rennes, CHU Rennes, INSERM, LTSI - UMR 1099, Rennes, France.'}, {'ForeName': 'Erwan', 'Initials': 'E', 'LastName': 'Flécher', 'Affiliation': 'Univ Rennes, CHU Rennes, INSERM, LTSI - UMR 1099, Rennes, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Galand', 'Affiliation': 'Univ Rennes, CHU Rennes, INSERM, LTSI - UMR 1099, Rennes, France. Electronic address: vincent.galand35@gmail.com.'}]",The American journal of cardiology,['10.1016/j.amjcard.2021.01.027'] 2104,33549017,Prognostic nomogram for patients with lung metastatic renal cell carcinoma: a SEER-based study.,"BACKGROUND Our study aimed to establish a clinically practical and reliable prognostic nomogram based on the important prognostic factors to predict the prognosis of patients with lung metastatic renal cell carcinoma (RCC). METHODS Clinical data of patients with lung metastatic RCC between 2010 and 2015 were collected from the SEER database. Prognostic nomogram was established using R software to predict the OS and CSS probability for individual patients. Consistency index (C-index), calibration curve and decision curve analysis (DCA) were used to assess the predictive performance of the nomogram, and to calibrated the nomogram for 1-, 2-, and 3-year cancer-specific survival (CSS) and overall survival (OS). RESULTS 1,563 patients were enrolled in this study. All patients were randomly divided into the primary cohort (937) and the validation cohort (626). Multivariate Cox regression showed that age, histology, N-stage, T-stage, surgery and radiotherapy were independent risk factor of OS, and histology, N-stage, T-stage, surgery were CSS related factors in patients with lung metastatic RCC in the primary cohort. The C-index of the nomogram OS was 0.662 and the C-index of CSS was 0.658 in the primary cohort. In the validation cohort, the C-index of the nomogram CSS and OS were 0.685 and 0.694, respectively. Moreover, the calibration curves showed good consistency between nomogram predictions and actual 1-, 2-, and 3-year OS and CSS rates in the primary and external verification cohorts. CONCLUSIONS The prognostic nomogram constructed in this study can provide an individualized treatment and risk assessment for survival in patients with lung metastatic RCC.",2021,The C-index of the nomogram OS was 0.662 and the C-index of CSS was 0.658 in the primary cohort.,"['1,563 patients were enrolled in this study', 'patients with lung metastatic renal cell carcinoma (RCC', 'patients with lung metastatic RCC', 'patients with lung metastatic RCC between 2010 and 2015 were collected from the SEER database', 'patients with lung metastatic renal cell carcinoma']",[],"['3-year cancer-specific survival (CSS) and overall survival (OS', 'Consistency index (C-index), calibration curve and decision curve analysis (DCA', '3-year OS and CSS rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C4721698', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0242638', 'cui_str': 'Surveillance, Epidemiology, and End Results Program'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]",[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0006751', 'cui_str': 'Calibration'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",1563.0,0.0382863,The C-index of the nomogram OS was 0.662 and the C-index of CSS was 0.658 in the primary cohort.,"[{'ForeName': 'Weipu', 'Initials': 'W', 'LastName': 'Mao', 'Affiliation': ""Department of Urology, Affiliated Zhongda Hospital of Southeast University, Nanjing, China; Surgical Research Center, Institute of Urology, Southeast University Medical School, Nanjing, China; Department of Urology, Nanjing Lishui District People's Hospital, Zhongda Hospital Lishui Branch, Southeast University, Nanjing, China.""}, {'ForeName': 'Zhenrui', 'Initials': 'Z', 'LastName': 'Fu', 'Affiliation': 'Department of Urology, Affiliated Zhongda Hospital of Southeast University, Nanjing, China.'}, {'ForeName': 'Keyi', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': ""Department of Urology, Shanghai Tenth People's Hospital, School of Medicine, Tongji University, Shanghai, China.""}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Urology, Affiliated Zhongda Hospital of Southeast University, Nanjing, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': ""Department of Urology, Affiliated Zhongda Hospital of Southeast University, Nanjing, China; Surgical Research Center, Institute of Urology, Southeast University Medical School, Nanjing, China; Department of Urology, Nanjing Lishui District People's Hospital, Zhongda Hospital Lishui Branch, Southeast University, Nanjing, China. njxb1982@126.com.""}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': ""Department of Urology, Affiliated Zhongda Hospital of Southeast University, Nanjing, China; Surgical Research Center, Institute of Urology, Southeast University Medical School, Nanjing, China; Department of Urology, Nanjing Lishui District People's Hospital, Zhongda Hospital Lishui Branch, Southeast University, Nanjing, China. mingchenseu@126.com.""}]",Annals of palliative medicine,['10.21037/apm-20-1488'] 2105,33548182,Cost-effectiveness of a Diet and Resistance Exercise Intervention in Community-Dwelling Older Adults: ProMuscle in Practice.,"OBJECTIVES Ageing is associated with a decline in functioning and a loss of independence, which will lead to increased health care costs in the future. The ProMuscle in Practice intervention was found to be effective in improving muscle strength, muscle mass, and functioning of older adults. The current study assesses the cost-effectiveness and perceived benefits of the intervention. DESIGN Trial-based cost-effectiveness analysis complemented by interviews. SETTING AND PARTICIPANTS A total of 168 community-dwelling older adults were included. Intervention participants started with a 12-week intensive support program, comprising resistance exercise guided by physiotherapists and consultations with a dietitian to increase protein intake. To maintain the adapted lifestyle pattern, they continued with a 12-week moderate support intervention. The control group received usual care. METHODS Costs and outcomes were measured at baseline, after 12 and 24 weeks. Costs were assessed from a societal perspective. Health care use, out-of-pocket costs, and productivity losses were measured using questionnaires. Intervention costs were quantified according to bottom-up micro-costing. Outcomes included quality of life (EQ-5D-5L) and physical functioning (Short Physical Performance Battery [SPPB]). Bootstrap analyses were used to generate cost-effectiveness planes and acceptability curves. Interviews with participants and professionals were conducted after 24 weeks to measure perceived benefits. RESULTS An Incremental Cost-Effectiveness Ratio of €2988 ($3385)/point increase in SPPB was found. The intervention has an 82.4% probability of being cost-effective at a willingness to pay (WTP) of €12.000 ($13.559)/point increase in SPPB. No change in quality of life was found according to EQ-5D-5L. Interviews, however, revealed a wide range of function-related perceived benefits. CONCLUSIONS AND IMPLICATIONS At a WTP of €12.000 ($13.559)/point increase in SPPB, the intervention was found to have an 82.4% probability of being cost-effective. Because generic quality of life questionnaires seem unable to detect subtle changes in public health interventions, future studies are advised to include targeted and specific questionnaires.",2021,An Incremental Cost-Effectiveness Ratio of €2988 ($3385)/point increase in SPPB was found.,"['Community-Dwelling Older Adults', 'A total of 168 community-dwelling older adults were included']","['usual care', 'intensive support program, comprising resistance exercise guided by physiotherapists and consultations with a dietitian to increase protein intake', 'Diet and Resistance Exercise Intervention']","['Cost-effectiveness', 'Incremental Cost-Effectiveness Ratio', 'quality of life (EQ-5D-5L) and physical functioning (Short Physical Performance Battery [SPPB', 'cost-effectiveness', 'muscle strength, muscle mass, and functioning of older adults', 'Intervention costs', 'quality of life', 'cost-effectiveness planes and acceptability curves']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",168.0,0.0219671,An Incremental Cost-Effectiveness Ratio of €2988 ($3385)/point increase in SPPB was found.,"[{'ForeName': 'Berber G', 'Initials': 'BG', 'LastName': 'Dorhout', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University and Research, the Netherlands. Electronic address: berber.dorhout@wur.nl.'}, {'ForeName': 'Annemien', 'Initials': 'A', 'LastName': 'Haveman-Nies', 'Affiliation': 'Chair group Consumption and Healthy Lifestyles, Wageningen University and Research, the Netherlands; GGD Noord- en Oost-Gelderland, Academic Collaborative Center AGORA, Zutphen, the Netherlands.'}, {'ForeName': 'Ellen J I', 'Initials': 'EJI', 'LastName': 'van Dongen', 'Affiliation': 'Food, Health and Consumer Research, Wageningen Food and Biobased Research, Wageningen, the Netherlands.'}, {'ForeName': 'Nick L W', 'Initials': 'NLW', 'LastName': 'Wezenbeek', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University and Research, the Netherlands.'}, {'ForeName': 'Esmée L', 'Initials': 'EL', 'LastName': 'Doets', 'Affiliation': 'Food, Health and Consumer Research, Wageningen Food and Biobased Research, Wageningen, the Netherlands.'}, {'ForeName': 'Anneke', 'Initials': 'A', 'LastName': 'Bulten', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University and Research, the Netherlands.'}, {'ForeName': 'G Ardine', 'Initials': 'GA', 'LastName': 'de Wit', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Lisette C P G M', 'Initials': 'LCPGM', 'LastName': 'de Groot', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University and Research, the Netherlands.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2020.12.036'] 2106,33546681,Physicians' attitudes to disability pension - impact of diagnosis: an experimental study.,"BACKGROUND The purpose of this study is to increase understanding of physicians' attitudes towards disability pension applicants, and the impact of diagnosis. We hypothesize that physicians are more likely to think that patients with physical illnesses should get a disability pension than those with mental illness or alcohol dependence. Disability pension is an important source of income for those unable to work because of a disability and type of diagnosis should not impact accessing these benefits. METHODS We conducted an experiment with a 2 by 3 factorial structure in Sweden. Each physician was randomly assigned one of six patient vignettes, with the same background description but with a different diagnosis. Each vignette had a diagnosis of either depression, alcohol dependence or low back pain, and was about a man or a woman. Logistic regression was used to examine the odds of a physician reporting that a patient should get a disability pension. Effects are reported in terms of odds ratios (ORs). RESULTS 1414 Swedish registered physicians in psychiatry or general practice (24% response rate) completed the survey. Physicians assigned the alcohol dependent vignette had OR 0.45 (95% CI: 0.34 to 0.60) for perceiving that a patient should get a disability pension compared to physicians assigned the low back pain vignette. Physicians assigned the depression vignette had OR 1.89 (95% CI: 1.42 to 2.50) for perceiving that a patient should get a disability pension compared to physicians assigned the low back pain vignette. CONCLUSION The patient diagnosis was associated with the physicians' response regarding if the patient should get a disability pension. A physician's perception is likely to impact a patient's access to disability pension.",2021,Physicians assigned the alcohol dependent vignette had OR 0.45 (95% CI: 0.34 to 0.60) for perceiving that a patient should get a disability pension compared to physicians assigned the low back pain vignette.,"['1414', 'patients with physical illnesses', 'Swedish registered physicians in psychiatry or general practice (24% response rate)\xa0completed the survey']",[],['odds ratios (ORs'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",[],"[{'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",1414.0,0.0769523,Physicians assigned the alcohol dependent vignette had OR 0.45 (95% CI: 0.34 to 0.60) for perceiving that a patient should get a disability pension compared to physicians assigned the low back pain vignette.,"[{'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'McAllister', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden. ashley.mcallister@unimelb.edu.au.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Milner', 'Affiliation': 'Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Engblom', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Corrigan', 'Affiliation': 'Department of Psychology, Illinois Institute of Technology, Chicago, USA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Burström', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}]",BMC health services research,['10.1186/s12913-020-06043-2'] 2107,33555215,Mitochondrial DNA copy number may be associated with attention deficit/hyperactivity disorder severity in treatment: a one-year follow-up study.,"OBJECTIVE Studies on etiopathogenesis of attention deficit/hyperactivity disorder (ADHD) are increasingly focussing on mitochondrial dysfunction. Children diagnosed with ADHD who had significantly higher mitochondrial DNA (mtDNA) copy numbers than healthy children in our first study were re-examined in 1-year follow-up to investigate effects of severity and treatment of ADHD on mtDNA. METHODS Twenty-eight patients who participated in previous study were included in this follow-up study. Patients were equally divided into two groups according to whether they had been receiving treatment. Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version, and Conners Parent Rating Scale (CPRS) were used. Polymerase chain reaction was performed. RESULTS Means of the first and second mtDNA copy were similar in all patients. mtDNA copy numbers did not change between two measurements in treated and non-treated groups. There was a correlation between CPRS ADHD index and inattention scores and mtDNA copy number in treated group. mtDNA copy number did not change in patients with ADHD over a period of 1 year regardless of treatment. CONCLUSIONS There may be a relationship between decreased ADHD severity with treatment and positive effects of mitochondrial functions. Mitochondrial dysfunction may play a role in pathophysiology of ADHD.KEY POINTSThis was the first study to follow up ADHD patients in order to investigate mitochondrial dysfunction by measuring mtDNA copy numbers 1 year after the initial measurements.mtDNA copy number, one of the best markers of mitochondrial dysfunction, did not change in ADHD patients over a period of 1 year regardless of treatment.Mitochondrial dysfunction may play a role in the pathophysiology of ADHD, where it may be involved with or without treatment.In the treated group, there was an association between decreased ADHD severity and reduced mtDNA copy numbers.There may be a relationship between decreased ADHD severity with treatment and the positive effects of mitochondrial functions.",2021,mtDNA copy numbers did not change between two measurements in treated and non-treated groups.,"['Twenty-eight patients who participated in previous study were included in this follow-up study', 'Children diagnosed with ADHD who had significantly higher mitochondrial DNA (mtDNA) copy numbers than healthy children']",[],"['Conners Parent Rating Scale (CPRS', 'CPRS ADHD index and inattention scores and mtDNA copy number']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012929', 'cui_str': 'Mitochondrial DNA'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0686744', 'cui_str': 'Well child'}]",[],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0424101', 'cui_str': 'Inattention'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012929', 'cui_str': 'Mitochondrial DNA'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",28.0,0.0284567,mtDNA copy numbers did not change between two measurements in treated and non-treated groups.,"[{'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Öğütlü', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Ankara City Hospital, Ankara, Turkey.'}, {'ForeName': 'İbrahim Selçuk', 'Initials': 'İS', 'LastName': 'Esin', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Ataturk University Faculty of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Haktan Bağış', 'Initials': 'HB', 'LastName': 'Erdem', 'Affiliation': 'Department of Medical Genetic, Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Abdülgani', 'Initials': 'A', 'LastName': 'Tatar', 'Affiliation': 'Department of Medical Genetic, Ataturk University Faculty of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Onur Burak', 'Initials': 'OB', 'LastName': 'Dursun', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University of Health Sciences Faculty of Medicine, Trabzon, Turkey.'}]",International journal of psychiatry in clinical practice,['10.1080/13651501.2021.1879158'] 2108,33555941,Addition of Lenalidomide to R-CHOP Improves Outcomes in Newly Diagnosed Diffuse Large B-Cell Lymphoma in a Randomized Phase II US Intergroup Study ECOG-ACRIN E1412.,"PURPOSE Lenalidomide combined with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) (R2CHOP) in untreated diffuse large B-cell lymphoma (DLBCL) has shown promising activity, particularly in the activated B-cell-like (ABC) subtype. Eastern Cooperative Oncology Group (ECOG)-ACRIN trial E1412 was a randomized phase II study comparing R2CHOP versus R-CHOP in untreated DLBCL. PATIENTS AND METHODS Patients with newly diagnosed DLBCL, stage II bulky-IV disease, International Prognostic Index (IPI) ≥ 2, and ECOG performance status ≤ 2 were eligible and randomly assigned 1:1 to R2CHOP versus R-CHOP for six cycles. Tumors were analyzed using the NanoString Lymph2Cx for cell of origin. The primary end point was progression-free survival (PFS) in all patients with the co-primary end point of PFS in ABC-DLBCL. Secondary end points included overall response rate (ORR), complete response (CR) rate, and overall survival (OS). RESULTS Three hundred forty-nine patients were enrolled; 280 patients (145 R2CHOP and 135 R-CHOP) were evaluable: 94 were ABC-DLBCL, 122 germinal center B-cell-like-DLBCL, 18 unclassifiable, and 46 unknowns. Baseline characteristics were well-balanced between arms, and the median age was 66 (range, 24-92); 70% of patients had stage IV disease; 34%, 43%, and 24% had IPI 2, 3, and 4 or 5, respectively. Myelosuppression was more common in the R2CHOP arm. The ORR and CR rate were 92% and 68% in R-CHOP and 97% ( P = .06) and 73% ( P = .43) in the R2CHOP arm, respectively. The median follow-up was 3.0 years; R2CHOP was associated with a 34% reduction in risk of progression or death versus R-CHOP (hazard ratio [HR], 0.66 95% CI, 0.43 to 1.01) and 3-year PFS of 73% versus 61%, one-sided P = .03, and an improvement in OS (83% and 75% at 3 years; HR, 0.67; one-sided P = .05). The PFS HR for R2CHOP was 0.67 for ABC-DLBCL, one-sided P = .1. CONCLUSION In this signal-seeking study, the addition of lenalidomide to R-CHOP (R2CHOP) improved outcomes in newly diagnosed DLBCL including patients with ABC-DLBCL.",2021,"The PFS HR for R2CHOP was 0.67 for ABC-DLBCL, one-sided P = .1. ","['≥ 2, and ECOG performance status ≤ 2 were eligible', 'Three hundred forty-nine patients were enrolled; 280 patients (145 R2CHOP and 135 R-CHOP) were evaluable: 94 were ABC-DLBCL, 122 germinal center B-cell-like-DLBCL, 18 unclassifiable, and 46 unknowns', 'Patients with newly diagnosed DLBCL, stage II bulky-IV disease, International Prognostic Index (IPI', 'untreated diffuse large B-cell lymphoma (DLBCL', 'Eastern Cooperative Oncology Group (ECOG)-ACRIN trial']","['R2CHOP versus R-CHOP', 'lenalidomide to R-CHOP (R2CHOP', 'rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) (R2CHOP', 'Lenalidomide to R-CHOP']","['overall response rate (ORR), complete response (CR) rate, and overall survival (OS', 'OS', 'ORR and CR rate', 'Myelosuppression', 'risk of progression or death versus R-CHOP', 'PFS HR for R2CHOP', 'progression-free survival (PFS', '3-year PFS']","[{'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1333296', 'cui_str': 'Activated B-cell type diffuse large B-cell lymphoma'}, {'cui': 'C0282491', 'cui_str': 'Structure of germinal center of lymph node'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1512894', 'cui_str': 'International Prognostic Index'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}]",349.0,0.188626,"The PFS HR for R2CHOP was 0.67 for ABC-DLBCL, one-sided P = .1. ","[{'ForeName': 'Grzegorz S', 'Initials': 'GS', 'LastName': 'Nowakowski', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Fangxin', 'Initials': 'F', 'LastName': 'Hong', 'Affiliation': 'Department of Data Sciences, Dana Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Scott', 'Affiliation': 'British Columbia Cancer Center for Lymphoid Cancer, Vancouver, Canada.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Macon', 'Affiliation': 'Division of Hematopathology, Mayo Clinic Rochester MN.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'King', 'Affiliation': 'Division of Hematopathology, Mayo Clinic Rochester MN.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Habermann', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Wagner-Johnston', 'Affiliation': 'Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Casulo', 'Affiliation': 'University of Rochester, NY.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Wade', 'Affiliation': 'Heartland NORP, Decatur IL.'}, {'ForeName': 'Gauri G', 'Initials': 'GG', 'LastName': 'Nagargoje', 'Affiliation': 'Marcy Hospital, Coon Rapids, MN.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Reynolds', 'Affiliation': 'Saint Joseph Mercy Hospital, Ann Arbor, MI.'}, {'ForeName': 'Jonathon B', 'Initials': 'JB', 'LastName': 'Cohen', 'Affiliation': 'Emory University-Winship Cancer Institute, Atlanta, GA.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Khan', 'Affiliation': 'Fox Case Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Amengual', 'Affiliation': 'Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Kristy L', 'Initials': 'KL', 'LastName': 'Richards', 'Affiliation': 'Weill Cornell Medicine, New York, NY.'}, {'ForeName': 'R F', 'Initials': 'RF', 'LastName': 'Little', 'Affiliation': 'National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Leonard', 'Affiliation': 'Weill Cornell Medicine, New York, NY.'}, {'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Friedberg', 'Affiliation': 'University of Rochester, NY.'}, {'ForeName': 'Lale', 'Initials': 'L', 'LastName': 'Kostakoglu', 'Affiliation': 'University of Virginia, Charlottesville VA.'}, {'ForeName': 'Brad S', 'Initials': 'BS', 'LastName': 'Kahl', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Witzig', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, MN.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01375'] 2109,33561274,Acute Nutritional Ketosis and Its Implications for Plasma Glucose and Glucoregulatory Peptides in Adults with Prediabetes: A Crossover Placebo-Controlled Randomized Trial.,"BACKGROUND The potential of a ketone monoester (β-hydroxybutyrate; KEβHB) supplement to rapidly mimic a state of nutritional ketosis offers a new therapeutic possibility for diabetes prevention and management. While KEβHB supplementation has a glucose-lowering effect in adults with obesity, its impact on glucose control in other insulin-resistant states is unknown. OBJECTIVES The primary objective was to investigate the effect of KEβHB-supplemented drink on plasma glucose in adults with prediabetes. The secondary objective was to determine its impact on plasma glucoregulatory peptides. METHODS This randomized controlled trial [called CETUS (Cross-over randomizEd Trial of β-hydroxybUtyrate in prediabeteS)] included 18 adults [67% men, mean age = 55 y, mean BMI (kg/m2) = 28.4] with prediabetes (glycated hemoglobin between 5.7% and 6.4% and/or fasting plasma glucose between 100 and 125 mg/dL). Participants were randomly assigned to receive KEβHB-supplemented and placebo drinks in a crossover sequence (washout period of 7-10 d between the drinks). Blood samples were collected from 0 to 150 min, at intervals of 30 min. Paired-samples t tests were used to investigate the change in the outcome variables [β-hydroxybutyrate (βHB), glucose, and glucoregulatory peptides] after both drinks. Repeated measures analyses were conducted to determine the change in concentrations of the prespecified outcomes over time. RESULTS Blood βHB concentrations increased to 3.5 mmol/L within 30 minutes after KEβHB supplementation. Plasma glucose AUC was significantly lower after KEβHB supplementation than after the placebo [mean difference (95% CI): -59 (-85.3, -32.3) mmol/L × min]. Compared with the placebo, KEβHB supplementation led to significantly greater AUCs for plasma insulin [0.237 (0.044, 0.429) nmol/L × min], C-peptide [0.259 (0.114, 0.403) nmol/L × min], and glucose-dependent insulinotropic peptide [0.243 (0.085, 0.401) nmol/L × min], with no significant differences in the AUCs for amylin, glucagon, and glucagon-like peptide 1. CONCLUSIONS Ingestion of the KEβHB-supplemented drink acutely increased the blood βHB concentrations and lowered the plasma glucose concentrations in adults with prediabetes. Further research is needed to investigate the dynamics of repeated ingestions of a KEβHB supplement by individuals with prediabetes, with a view to preventing new-onset diabetes. This trial was registered at www.clinicaltrials.gov as NCT03889210.",2021,"Compared with the placebo, KEβHB supplementation led to significantly greater AUCs for plasma insulin [0.237 (0.044, 0.429) nmol/L × min], C-peptide [0.259 (0.114, 0.403) nmol/L × min], and glucose-dependent insulinotropic peptide [0.243 (0.085, 0.401) nmol/L × min], with no significant differences in the AUCs for amylin, glucagon, and glucagon-like peptide 1. ","['Adults with Prediabetes', '18 adults [67% men, mean age\xa0=\xa055 y', 'adults with prediabetes', 'adults with obesity']","['KEβHB-supplemented drink', 'ketone monoester (β-hydroxybutyrate; KEβHB', 'KEβHB-supplemented and placebo drinks', 'placebo', 'β-hydroxybUtyrate', 'placebo, KEβHB supplementation', 'Placebo']","['outcome variables [β-hydroxybutyrate (βHB), glucose, and glucoregulatory peptides', 'blood βHB concentrations', 'Plasma glucose AUC', 'Blood βHB concentrations', 'plasma glucose concentrations', 'fasting plasma glucose', 'AUCs for plasma insulin', 'plasma glucose', 'prediabetes (glycated hemoglobin', 'AUCs for amylin, glucagon, and glucagon-like peptide 1']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0063684', 'cui_str': 'Amylin'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}]",18.0,0.134376,"Compared with the placebo, KEβHB supplementation led to significantly greater AUCs for plasma insulin [0.237 (0.044, 0.429) nmol/L × min], C-peptide [0.259 (0.114, 0.403) nmol/L × min], and glucose-dependent insulinotropic peptide [0.243 (0.085, 0.401) nmol/L × min], with no significant differences in the AUCs for amylin, glucagon, and glucagon-like peptide 1. ","[{'ForeName': 'Sakina H', 'Initials': 'SH', 'LastName': 'Bharmal', 'Affiliation': 'School of Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Jaelim', 'Initials': 'J', 'LastName': 'Cho', 'Affiliation': 'School of Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Gisselle', 'Initials': 'G', 'LastName': 'C Alarcon Ramos', 'Affiliation': 'School of Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Juyeon', 'Initials': 'J', 'LastName': 'Ko', 'Affiliation': 'School of Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cameron-Smith', 'Affiliation': 'Singapore Institute for Clinical Sciences, Agency for Science, Technology, and Research, Singapore.'}, {'ForeName': 'Maxim S', 'Initials': 'MS', 'LastName': 'Petrov', 'Affiliation': 'School of Medicine, University of Auckland, Auckland, New Zealand.'}]",The Journal of nutrition,['10.1093/jn/nxaa417'] 2110,33566107,Effect of Levothyroxine Therapy on the Development of Depressive Symptoms in Older Adults With Subclinical Hypothyroidism: An Ancillary Study of a Randomized Clinical Trial.,"Importance Previous trials on the effect of levothyroxine on depressive symptom scores in patients with subclinical hypothyroidism were limited by small sample sizes (N = 57 to 94) and potential biases. Objective To assess the effect of levothyroxine on the development of depressive symptoms in older adults with subclinical hypothyroidism in the largest trial on this subject and to update a previous meta-analysis including the results from this study. Design, Setting, and Participants This predefined ancillary study analyzed data from participants in the Thyroid Hormone Replacement for Untreated Older Adults with Subclinical Hypothyroidism (TRUST) trial, a double-blind, randomized, placebo-controlled, parallel-group clinical trial conducted from April 2013 to October 31, 2016. The TRUST trial included adults aged 65 years or older diagnosed with subclinical hypothyroidism, defined as the presence of persistently elevated thyroid-stimulating hormone (TSH) levels (4.6-19.9 mIU/L) with free thyroxine (T4) within the reference range. Participants were identified from clinical and general practitioner laboratory databases and recruited from the community in Switzerland, the Netherlands, Ireland, and the UK. This ancillary study included a subgroup of 472 participants from the Netherlands and Switzerland; after exclusions, a total of 427 participants (211 randomized to levothyroxine and 216 to placebo) were analyzed. This analysis was conducted from December 1, 2019, to September 1, 2020. Interventions Randomization to either levothyroxine or placebo. Main Outcomes and Measures Depressive symptom scores after 12 months measured with the Geriatric Depression Scale (GDS-15), with higher scores indicating more depressive symptoms (minimal clinically important difference = 2). Results A total of 427 participants with subclinical hypothyroidism (mean [SD] age, 74.52 [6.29] years; 239 women [56%]) were included in this analysis. The mean (SD) TSH level was 6.57 (2.22) mIU/L at baseline and decreased after 12 months to 3.83 (2.29) mIU/L in the levothyroxine group; in the placebo group, it decreased from 6.55 (2.04) mIU/L to 5.91 (2.66) mIU/L. At baseline, the mean (SD) GDS-15 score was 1.26 (1.85) in the levothyroxine group and 0.96 (1.58) in the placebo group. The mean (SD) GDS-15 score at 12 months was 1.39 (2.13) in the levothyroxine and 1.07 (1.67) in the placebo group with an adjusted between-group difference of 0.15 for levothyroxine vs placebo (95% CI, -0.15 to 0.46; P = .33). In a subgroup analysis including participants with a GDS-15 of at least 2, the adjusted between-group difference was 0.61 (95% CI, -0.32 to 1.53; P = .20). Results did not differ according to age, sex, or TSH levels. A previous meta-analysis (N = 278) on the association of levothyroxine with depressive symptoms was updated to include these findings, resulting in an overall standardized mean difference of 0.09 (95% CI, -0.05 to 0.22). Conclusions and Relevance This ancillary study of a randomized clinical trial found that depressive symptoms did not differ after levothyroxine therapy compared with placebo after 12 months; thus, these results do not provide evidence in favor of levothyroxine therapy in older persons with subclinical hypothyroidism to reduce the risk of developing depressive symptoms. Trial Registration ClinicalTrials.gov Identifier: NCT01853579.",2021,"Results did not differ according to age, sex, or TSH levels.","['for Untreated Older Adults with Subclinical Hypothyroidism (TRUST) trial', 'December 1, 2019, to September 1, 2020', 'Participants were identified from clinical and general practitioner laboratory databases and recruited from the community in Switzerland, the Netherlands, Ireland, and the UK', 'older adults with subclinical hypothyroidism', 'patients with subclinical hypothyroidism were limited by small sample sizes (N\u2009=\u200957 to 94) and potential biases', 'older persons with subclinical hypothyroidism', 'adults aged 65 years or older diagnosed with subclinical hypothyroidism, defined as the presence of persistently elevated thyroid-stimulating hormone (TSH) levels (4.6-19.9 mIU/L) with free thyroxine (T4) within the reference range', '427 participants with subclinical hypothyroidism (mean [SD] age, 74.52 [6.29] years; 239 women [56', 'Older Adults With Subclinical Hypothyroidism', '472 participants from the Netherlands and Switzerland; after exclusions, a total of 427 participants (211 randomized to']","['levothyroxine therapy', 'placebo', 'GDS-15', 'Levothyroxine Therapy', 'Thyroid Hormone Replacement', 'levothyroxine or placebo', 'levothyroxine and 216 to placebo', 'levothyroxine']","['Depressive Symptoms', 'mean (SD) TSH level', 'depressive symptom scores', 'depressive symptoms', 'Geriatric Depression Scale (GDS-15', 'Measures\n\n\nDepressive symptom scores', 'mean (SD']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0271790', 'cui_str': 'Subclinical hypothyroidism'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0586553', 'cui_str': 'Raised TSH level'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0439462', 'cui_str': 'mIU/L'}, {'cui': 'C0202225', 'cui_str': 'T4 free measurement'}, {'cui': 'C0086715', 'cui_str': 'Normal range'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C4708905', 'cui_str': '216'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",427.0,0.735848,"Results did not differ according to age, sex, or TSH levels.","[{'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Wildisen', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Feller', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Del Giovane', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Elisavet', 'Initials': 'E', 'LastName': 'Moutzouri', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Du Puy', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Simon P', 'Initials': 'SP', 'LastName': 'Mooijaart', 'Affiliation': 'Department of Gerontology and Geriatrics, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Tinh-Hai', 'Initials': 'TH', 'LastName': 'Collet', 'Affiliation': 'Service of Endocrinology, Diabetology, Nutrition, and Therapeutic Education, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Rosalinde K E', 'Initials': 'RKE', 'LastName': 'Poortvliet', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Kearney', 'Affiliation': 'School of Public Health, University College Cork, Cork, Ireland.'}, {'ForeName': 'Terence J', 'Initials': 'TJ', 'LastName': 'Quinn', 'Affiliation': 'Institute of Cardiovascular Medicine, University of Glasgow, Glasgow, Scotland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Klöppel', 'Affiliation': 'University Hospital of Old Age Psychiatry, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Douglas C', 'Initials': 'DC', 'LastName': 'Bauer', 'Affiliation': 'Departments of Medicine and Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Robin P', 'Initials': 'RP', 'LastName': 'Peeters', 'Affiliation': 'Department of Medicine, Erasmus Medical Center, Rotterdam, the Netherland.'}, {'ForeName': 'Rudi', 'Initials': 'R', 'LastName': 'Westendorp', 'Affiliation': 'Department of Public Health and Center for Healthy Aging, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Drahomir', 'Initials': 'D', 'LastName': 'Aujesky', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Jacobijn', 'Initials': 'J', 'LastName': 'Gussekloo', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rodondi', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.36645'] 2111,33567462,[Planning and Design of a Prospective Randomised Multi-Centre Trial on the Repair of Large Hiatal Hernias with Sutures vs. Pledgeted Sutures vs. Absorbable Mesh].,"BACKGROUND The hernia recurrence rate after surgical treatment of large hiatal hernias is still very high. The optimal technique to reduce the recurrence rate is still under debate. The aim of this work is to clarify whether pledgeted reinforced sutures or a resorbable mesh can reduce the recurrence rate compared to hiatus closure with only sutures. MATERIALS AND METHODS An Austria-wide, multi-centre, prospective, randomised study was planned. The study protocol was prepared by the main test centre (University Clinic for General, Visceral and Thoracic Surgery, Paracelsus Medical University Salzburg). The study includes patients who are scheduled to undergo laparoscopic or robot-assisted surgery for a large symptomatic hiatal hernia. A large hiatal hernia is defined as > 5 cm in manometry or gastroscopy or at least ⅓ of the stomach lying intrathoracically. The primary study endpoint is defined as the hernia recurrence rate, objectively assessed by gastroscopy. After inclusion in the study, patients will be followed up for 6 months, 1 year, 3 years and 5 years after the operation, using standardised questionnaires and gastroscopy. The power calculation showed a requirement of 55 patients per group. Preoperative randomisation and data management are software-based. RESULTS The study approval by the leading ethics committee is currently pending and the study itself has been registered on ClinicalTrials.gov since October 2020. The Clinical Trials Registration Number is NCT04591860. Five clinics are participating in the study at the moment and all centres are actively enrolling patients. The duration of the study is set until January 2027. CONCLUSION This study is the world's first prospective randomised study that examines the value of pledgets and resorbable mesh to reduce the recurrence rate after treatment of large hiatal hernias. The results will help to find the optimal technique to close the hiatus of large hiatal hernias.",2021,"After inclusion in the study, patients will be followed up for 6 months, 1 year, 3 years and 5 years after the operation, using standardised questionnaires and gastroscopy.","['patients who are scheduled to undergo laparoscopic or robot-assisted surgery for a large symptomatic hiatal hernia', 'large hiatal hernias', 'An Austria-wide, multi-centre', 'Five clinics are participating in the study at the moment and all centres are actively enrolling patients', 'main test centre (University Clinic for General, Visceral and Thoracic Surgery, Paracelsus Medical University Salzburg']","['Sutures vs. Pledgeted Sutures vs. Absorbable Mesh', 'pledgeted reinforced sutures or a resorbable mesh']","['hernia recurrence rate, objectively assessed by gastroscopy', 'hernia recurrence rate', 'recurrence rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C3489393', 'cui_str': 'Hiatal hernia'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C4521311', 'cui_str': 'Pledget'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}]","[{'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0017195', 'cui_str': 'Endoscopy of stomach'}]",,0.0481248,"After inclusion in the study, patients will be followed up for 6 months, 1 year, 3 years and 5 years after the operation, using standardised questionnaires and gastroscopy.","[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Koch', 'Affiliation': 'Universitätsklinik für Allgemein-, Viszeral- und Thoraxchirurgie, Landeskrankenhaus Salzburg - Universitätsklinikum der Paracelsus Medizinischen Privatuniversität, Salzburg, Österreich.'}, {'ForeName': 'Burkhard H A', 'Initials': 'BHA', 'LastName': 'von Rahden', 'Affiliation': 'Universitätsklinik für Allgemein-, Viszeral- und Thoraxchirurgie, Landeskrankenhaus Salzburg - Universitätsklinikum der Paracelsus Medizinischen Privatuniversität, Salzburg, Österreich.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Wykypiel', 'Affiliation': 'Department Operative Medizin, Universitätsklinik für Viszeral-, Transplantations- und Thoraxchirurgie, Medizinische Universität Innsbruck, Österreich.'}, {'ForeName': 'Sebastian F', 'Initials': 'SF', 'LastName': 'Schoppmann', 'Affiliation': 'Universitätsklinik für Chirurgie, Medizinische Universität Wien, Österreich.'}, {'ForeName': 'Reinhold', 'Initials': 'R', 'LastName': 'Függer', 'Affiliation': 'Abteilung für Allgemein- und Viszeralchirurgie, Ordensklinikum Linz, Barmherzige Schwestern Hospital Linz, Österreich.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Rosanelli', 'Affiliation': 'Abteilung für Chirurgie, Krankenhaus der Elisabethinen Graz, Österreich.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Emmanuel', 'Affiliation': 'Universitätsklinik für Allgemein-, Viszeral- und Thoraxchirurgie, Landeskrankenhaus Salzburg - Universitätsklinikum der Paracelsus Medizinischen Privatuniversität, Salzburg, Österreich.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weitzendorfer', 'Affiliation': 'Universitätsklinik für Allgemein-, Viszeral- und Thoraxchirurgie, Landeskrankenhaus Salzburg - Universitätsklinikum der Paracelsus Medizinischen Privatuniversität, Salzburg, Österreich.'}]",Zentralblatt fur Chirurgie,['10.1055/a-1369-9694'] 2112,33582249,Induction chemotherapy plus concomitant chemoradiotherapy in nasopharyngeal carcinoma: An updated network meta-analysis.,"BACKGROUND Induction chemotherapy (IC) added to concurrent chemoradiotherapy (CCRT) appears to be superior to CCRT alone for locally-advanced nasopharyngeal carcinoma (NPC). The main objective of this network meta-analysis (NMA) was to assess the impact of different IC regimens on patient outcome. PATIENTS AND METHODS We systematically searched and extracted data from randomized, controlled trials involving stage III-IV NPC patients randomly assigned to receive IC + CCRT vs. CCRT alone. Overall survival (OS), locoregional recurrence-free survival (LRFS) and distant metastasis-free survival (DMFS) in the two arms were compared using hazard ratios (HRs). RESULTS Eight clinical trials were identified including 2362 patients. OS-benefit from doublet IC regimens, in particular platinum-docetaxel and platinum-gemcitabine regimens, was seen. With regard to LRFS, docetaxel-platinum-5FU regimen showed a greater impact than the others. An indirect comparison between taxane- and gemcitabine-based IC regimens showed a benefit of the latter in terms of OS and DMFS. CONCLUSIONS Although CCRT with cisplatin has been the gold standard of treatment in NPC for several years. Docetaxel + cisplatin-IC and cisplatin + gemcitabine-IC regimens have a positive impact on survival in locally-advanced NPC and should be considered the new standard option.",2021,"Overall survival (OS), locoregional recurrence-free survival (LRFS) and distant metastasis-free survival (DMFS) in the two arms were compared using hazard ratios (HRs). ","['stage III-IV NPC patients', 'Nasopharyngeal Carcinoma', '2362 patients', 'locally-advanced nasopharyngeal carcinoma (NPC']","['CCRT with cisplatin', 'platinum-docetaxel and platinum-gemcitabine', 'taxane- and gemcitabine-based IC regimens', 'LRFS, docetaxel-platinum-5FU regimen', 'Induction Chemotherapy plus Concomitant Chemoradiotherapy', 'IC\u2009+\u2009CCRT vs. CCRT alone', 'CCRT alone', 'Docetaxel\u2009+\u2009cisplatin-IC and cisplatin\u2009+\u2009gemcitabine-IC regimens', 'Induction chemotherapy (IC) added to concurrent chemoradiotherapy (CCRT']","['Overall survival (OS), locoregional recurrence-free survival (LRFS) and distant metastasis-free survival (DMFS']","[{'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",,0.124424,"Overall survival (OS), locoregional recurrence-free survival (LRFS) and distant metastasis-free survival (DMFS) in the two arms were compared using hazard ratios (HRs). ","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Bongiovanni', 'Affiliation': 'Osteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy. Electronic address: alberto.bongiovanni@irst.emr.it.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Vagheggini', 'Affiliation': 'Unit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Fausti', 'Affiliation': 'Osteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mercatali', 'Affiliation': 'Osteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Sebastiano', 'Initials': 'S', 'LastName': 'Calpona', 'Affiliation': 'Osteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Giandomenico', 'Initials': 'G', 'LastName': 'Di Menna', 'Affiliation': 'Osteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Miserocchi', 'Affiliation': 'Osteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Ibrahim', 'Affiliation': 'Osteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}]",Critical reviews in oncology/hematology,['10.1016/j.critrevonc.2021.103244'] 2113,33587286,Evaluation of the Pharmacokinetics and Exposure-Response Relationship of Dapagliflozin in Patients without Diabetes and with Chronic Kidney Disease.,"BACKGROUND AND OBJECTIVE Dapagliflozin, a sodium-glucose co-transporter inhibitor, was originally developed as an oral glucose-lowering drug for the treatment of type 2 diabetes mellitus. Emerging data suggest that cardiovascular and kidney benefits extend to patients without diabetes. Limited pharmacological data are, however, available in patients without diabetes. We aimed to characterise the pharmacokinetic profile of dapagliflozin in patients with chronic kidney disease without type 2 diabetes. METHODS Plasma samples were collected in a randomised, placebo-controlled, double-blind, cross-over trial (DIAMOND, NCT03190694, n = 53) that assessed the effects of 10 mg of dapagliflozin in patients with a glomerular filtration rate ≥ 25 mL/min/1.73 m 2 and proteinuria > 500 mg/day. Mixed-effects models were used to develop a pharmacokinetic model and to evaluate the association between plasma exposure and response. RESULTS Plasma concentrations (n = 430 observations) from 48 patients (mean age 50.8 years, mean glomerular filtration rate 57.9 mL/min/1.73 m 2 , median proteinuria 1115 mg/24 h) were best described using a two-compartment model with first-order elimination. Apparent clearance and volume of distribution were 11.7 (95% confidence interval 10.7-12.7) L/h and 44.9 (95% confidence interval 39.0-50.9) L, respectively. Median dapagliflozin plasma exposure was 740.9 ng h/mL (2.5th-97.5th percentiles: 434.0-1615.3). Plasma exposure increased with decreasing kidney function. Every 100-ng h/mL increment in dapagliflozin plasma exposure was associated with a decrease in the urinary albumin:creatinine ratio (β = - 2.8%, p = 0.01), glomerular filtration rate (β = - 0.5 mL/min/1.73 m 2 , p < 0.01) and systolic blood pressure (β = - 0.4 mmHg, p = 0.03). CONCLUSIONS The dapagliflozin plasma concentration-time profile in patients with non-diabetic kidney disease appears similar to the profile of patients with diabetic kidney disease described in the literature. Furthermore, the plasma exposure was associated with changes in risk markers for kidney disease.",2021,Apparent clearance and volume of distribution were 11.7 (95% confidence interval 10.7-12.7) L/h and 44.9,"['patients with a glomerular filtration rate ≥\xa025', 'patients without diabetes', 'Patients without Diabetes and with Chronic Kidney Disease', 'patients with non-diabetic kidney disease', 'type 2 diabetes mellitus', 'patients with chronic kidney disease without type 2 diabetes']","['Dapagliflozin', 'dapagliflozin', 'placebo']","['mean glomerular filtration rate', 'proteinuria', 'systolic blood pressure', 'glomerular filtration rate', 'urinary albumin:creatinine ratio', 'Apparent clearance and volume of distribution', 'dapagliflozin plasma exposure', 'Median dapagliflozin plasma exposure', 'kidney function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}]",,0.161272,Apparent clearance and volume of distribution were 11.7 (95% confidence interval 10.7-12.7) L/h and 44.9,"[{'ForeName': 'Annemarie B', 'Initials': 'AB', 'LastName': 'van der Aart-van der Beek', 'Affiliation': 'Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, PO Box 30 001, 9700 RB, Groningen, The Netherlands.'}, {'ForeName': 'Jeroen V', 'Initials': 'JV', 'LastName': 'Koomen', 'Affiliation': 'Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, PO Box 30 001, 9700 RB, Groningen, The Netherlands.'}, {'ForeName': 'Claire C J', 'Initials': 'CCJ', 'LastName': 'Dekkers', 'Affiliation': 'Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, PO Box 30 001, 9700 RB, Groningen, The Netherlands.'}, {'ForeName': 'Sean J', 'Initials': 'SJ', 'LastName': 'Barbour', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Boulton', 'Affiliation': 'Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Ron T', 'Initials': 'RT', 'LastName': 'Gansevoort', 'Affiliation': 'Department of Nephrology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Greasley', 'Affiliation': 'Early Clinical Development, Research and Early Development, Cardiovascular, Renal and Metabolism (CVRM), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Abdul Halim', 'Initials': 'AH', 'LastName': 'Abdul Gafor', 'Affiliation': 'Department of Medicine, Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Gozewijn D', 'Initials': 'GD', 'LastName': 'Laverman', 'Affiliation': 'Department of Internal Medicine, ZGT Hospital, Almelo and Hengelo, The Netherlands.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'The George Institute for Global Health, Royal Prince Alfred Hospital and University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Soo Kun', 'Initials': 'SK', 'LastName': 'Lim', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Stevens', 'Affiliation': 'Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, PO Box 30 001, 9700 RB, Groningen, The Netherlands.'}, {'ForeName': 'Marc G', 'Initials': 'MG', 'LastName': 'Vervloet', 'Affiliation': 'Department of Nephrology and Amsterdam Cardiovascular Sciences, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Division of Nephrology, Department of Medicine, University Health Network and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Cattran', 'Affiliation': 'Division of Nephrology, Department of Medicine, University Health Network and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Heather N', 'Initials': 'HN', 'LastName': 'Reich', 'Affiliation': 'Division of Nephrology, Department of Medicine, University Health Network and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'David Z I', 'Initials': 'DZI', 'LastName': 'Cherney', 'Affiliation': 'Division of Nephrology, Department of Medicine, University Health Network and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, PO Box 30 001, 9700 RB, Groningen, The Netherlands. h.j.lambers.heerspink@umcg.nl.'}]",Clinical pharmacokinetics,['10.1007/s40262-020-00956-1'] 2114,33820541,Effects of different thermal insulation methods on the nasopharyngeal temperature in patients undergoing laparoscopic hysterectomy: a prospective randomized controlled trial.,"BACKGROUND This study explored the comparison of the thermal insulation effect of incubator to infusion thermometer in laparoscopic hysterectomy. METHODS We assigned 75 patients enrolled in the study randomly to three groups: Group A: Used warming blanket; group B: Used warming blanket and infusion thermometer; group C: Used warming blanket and incubator. The nasopharyngeal temperature at different time points during the operation served as the primary outcome. RESULTS The nasopharyngeal temperature of the infusion heating group was significantly higher than that of the incubator group 60 min from the beginning of surgery (T3): 36.10 ± 0.20 vs 35.81 ± 0.20 (P<0.001)90 min from the beginning of surgery (T4): 36.35 ± 0.20 vs 35.85 ± 0.17 (P<0.001). Besides, the nasopharyngeal temperature of the incubator group was significantly higher compared to that of the control group 60 min from the beginning of surgery (T3): 35.81 ± 0.20 vs 35.62 ± 0.18 (P<0.001); 90 min from the beginning of surgery (T4): 35.85 ± 0.17 vs 35.60 ± 0.17 (P<0.001). Regarding the wake-up time, that of the control group was significantly higher compared to the infusion heating group: 24 ± 4 vs 21 ± 4 (P = 0.004) and the incubator group: 24 ± 4 vs 22 ± 4 (P = 0.035). CONCLUSION Warming blanket (38 °C) combined infusion thermometer (37 °C) provides better perioperative thermal insulation. Hospitals without an infusion thermometer can opt for an incubator as a substitute. TRIAL REGISTRATION This trial was registered with ChiCTR2000039162 , 20 October 2020.",2021,The nasopharyngeal temperature of the infusion heating group was significantly higher than that of the incubator group 60 min from the beginning of surgery (T3): 36.10 ± 0.20 vs 35.81 ± 0.20 (P<0.001)90 min from the beginning of surgery (T4): 36.35 ± 0.20 vs 35.85 ± 0.17 (P<0.001).,"['patients undergoing laparoscopic hysterectomy', '75 patients enrolled in the study randomly to three groups: Group A']","['Used warming blanket; group B: Used warming blanket and infusion thermometer; group C: Used warming blanket and incubator', 'thermal insulation methods', 'Warming blanket (38\u2009°C']",['nasopharyngeal temperature'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0179330', 'cui_str': 'Blanket'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0039818', 'cui_str': 'Thermometer'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0021178', 'cui_str': 'Incubators'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0184351', 'cui_str': 'Warming blanket'}]","[{'cui': 'C3697005', 'cui_str': 'Nasopharyngeal temperature'}]",75.0,0.0992945,The nasopharyngeal temperature of the infusion heating group was significantly higher than that of the incubator group 60 min from the beginning of surgery (T3): 36.10 ± 0.20 vs 35.81 ± 0.20 (P<0.001)90 min from the beginning of surgery (T4): 36.35 ± 0.20 vs 35.85 ± 0.17 (P<0.001).,"[{'ForeName': 'Guanyu', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Pain and Perioperative Medicine, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China.'}, {'ForeName': 'Zefei', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, Pain and Perioperative Medicine, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Department of Anesthesiology, Pain and Perioperative Medicine, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China.'}, {'ForeName': 'Shifeng', 'Initials': 'S', 'LastName': 'He', 'Affiliation': 'Department of Anesthesiology, Pain and Perioperative Medicine, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China.'}, {'ForeName': 'Wanyue', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Pain and Perioperative Medicine, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China.'}, {'ForeName': 'Zhentao', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, Pain and Perioperative Medicine, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China. gentlesun@126.com.'}]",BMC anesthesiology,['10.1186/s12871-021-01324-7'] 2115,33586144,Speed of electroconvulsive therapy for depression: Effects of electrode placement.,"OBJECTIVE Electroconvulsive therapy (ECT) is a rapidly effective treatment for severe depression. Treatment with right unilateral (RUL) or bitemporal (BT) ECT may explain individual differences in speed of ECT effectiveness. There is limited evidence for demographic and clinical factors that predict speed of response and remission with ECT. We aimed to investigate differences in speed of improvement as well as achieving response and remission between twice-weekly brief-pulse high-dose (6 × seizure threshold) RUL ECT and moderate-dose (1.5 × seizure threshold) BT ECT. We also explored demographic and clinical characteristics that predict speed of response and remission. METHODS Weekly 24-item Hamilton Depression Rating Scale scores were assessed among patients with severe depression who participated in the EFFECT-Dep trial (ISRCTN23577151). Speed of improvement in patients randomised to RUL ECT (n = 69) or BT ECT (n = 69) was compared using independent sample t tests. Pearson's chi-square and Fisher's exact tests compared proportions of responders and remitters at each weekly assessment. Predictors of speed of response and remission were explored using Cox regression analyses. RESULTS There were no significant differences between RUL and BT ECT in speed of improvement, response or remission. Exploratory analyses indicated that speed of response and remission were not predicted by a wide variety of demographic and clinical characteristics. CONCLUSION ECT electrode placement did not have predictive value when determining speed of improvement, response and remission with ECT. Other clinical factors, such as cognitive side-effects, may be more relevant when making the clinical choice between RUL and BT ECT.",2021,Treatment with right unilateral (RUL) or bitemporal (BT) ECT may explain individual differences in speed of ECT effectiveness.,['patients with severe depression who participated in the EFFECT-Dep trial (ISRCTN23577151'],"['electroconvulsive therapy', 'RUL ECT', 'ECT electrode placement', 'right unilateral (RUL) or bitemporal (BT) ECT', 'BT ECT', 'electrode placement', 'Electroconvulsive therapy (ECT']","['RUL and BT ECT in speed of improvement, response or remission', '24-item Hamilton Depression Rating Scale scores', 'speed of response and remission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0588008', 'cui_str': 'Severe depression'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0057472', 'cui_str': '1-(2-(dodecyloxy)ethyl)pyrrolidine hydrochloride'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0562344', 'cui_str': 'Unilateral electroconvulsive therapy'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0445452', 'cui_str': 'Bitemporal'}]","[{'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0445452', 'cui_str': 'Bitemporal'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",69.0,0.107202,Treatment with right unilateral (RUL) or bitemporal (BT) ECT may explain individual differences in speed of ECT effectiveness.,"[{'ForeName': 'Celine A', 'Initials': 'CA', 'LastName': 'Fox', 'Affiliation': ""Department of Psychiatry, Trinity College Dublin, St. Patrick's University Hospital, Dublin 8, Ireland.""}, {'ForeName': 'Declan M', 'Initials': 'DM', 'LastName': 'McLoughlin', 'Affiliation': ""Department of Psychiatry, Trinity College Dublin, St. Patrick's University Hospital, Dublin 8, Ireland.""}]",Acta psychiatrica Scandinavica,['10.1111/acps.13286'] 2116,33587901,Do Blue-blocking Lenses Reduce Eye Strain From Extended Screen Time? A Double-Masked Randomized Controlled Trial.,"PURPOSE To investigate if blue-blocking lenses are effective in reducing the ocular signs and symptoms of eye strain associated with computer use. DESIGN Double-masked, randomized controlled trial. METHODS A total of 120 symptomatic computer users were randomly assigned (1:1) into a ""positive"" or ""negative"" advocacy arm (ie, a clinician either advocating or not advocating for the intervention via a prerecorded video). Participants were further sub-randomized (1:1) to receive either clear (placebo) or blue-blocking spectacles. All participants were led to believe they had received an active intervention. Participants performed a 2-hour computer task while wearing their assigned spectacle intervention. The prespecified primary outcome measures were the mean change (post- minus pre-computer task) in eye strain symptom score and critical flicker-fusion frequency (CFF, an objective measure of eye strain). The study also investigated whether clinician advocacy of the intervention (in a positive or negative light) modulated clinical outcomes. RESULTS All participants completed the study. In the primary analysis, for CFF, no significant effect was found for advocacy type (positive or negative, p = .164) and spectacle intervention type (blue-blocking or clear lens, p = .304). Likewise, for eye strain symptom score, no differences were found for advocacy (p = .410) or spectacle lens types (p = .394). No adverse events were documented. CONCLUSIONS Blue-blocking lenses did not alter signs or symptoms of eye strain with computer use relative to standard clear lenses. Clinician advocacy type had no bearing on clinical outcomes.",2021,"Likewise, for eye strain symptom score, no differences were found for advocacy (p=0.410) or spectacle lens types (p=0.394).",['120 symptomatic computer users'],"['blue-blocking lenses', 'clear (placebo) or blue-blocking spectacles', ""positive' or 'negative' advocacy arm (i.e., a clinician either advocating, or not advocating, for the intervention via a pre-recorded video"", 'Blue-blocking lenses']","['mean change (post- minus pre-computer task) in eye strain symptom score and critical flicker-fusion frequency (CFF, an objective measure of eye strain', 'eye strain symptom score', 'adverse events']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0009622', 'cui_str': 'Computer'}]","[{'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0150446', 'cui_str': 'Advocacy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0004095', 'cui_str': 'Accommodative asthenopia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016236', 'cui_str': 'Flicker Fusion'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",120.0,0.467133,"Likewise, for eye strain symptom score, no differences were found for advocacy (p=0.410) or spectacle lens types (p=0.394).","[{'ForeName': 'Sumeer', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'From the Department of Optometry and Vision Sciences, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Downie', 'Affiliation': 'From the Department of Optometry and Vision Sciences, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Anderson', 'Affiliation': 'From the Department of Optometry and Vision Sciences, The University of Melbourne, Parkville, Victoria, Australia.. Electronic address: aaj@unimelb.edu.au.'}]",American journal of ophthalmology,['10.1016/j.ajo.2021.02.010'] 2117,33591006,Safety and Efficacy of Human Chorionic Gonadotropin Hormone-Derivative EA-230 in Cardiac Surgery Patients: A Randomized Double-Blind Placebo-Controlled Study.,"OBJECTIVES To determine the safety and efficacy of human chorionic gonadotropin hormone-derivative EA-230 in cardiac surgery patients. Cardiac surgery induces systemic inflammation and may impair renal function, affecting patient outcome. EA-230 exerted immunomodulatory and renoprotective effects in preclinical models and was safe and showed efficacy in phase I and II human studies. DESIGN Double-blinded, placebo-controlled, randomized study. SETTING Collaboration of the Cardiothoracic Surgery, Anesthesiology, and the Intensive Care departments of a tertiary hospital in the Netherlands. PATIENTS One hundred eighty patients undergoing an on-pump coronary artery bypass procedure with or without concomitant valve surgery. INTERVENTIONS Ninety mg/kg/hr EA-230 or placebo administered during surgery. MEASUREMENTS AND MAIN RESULTS During the study, no safety concerns emerged. EA-230 did not modulate interleukin-6 plasma concentrations (area under the curve 2,730 pg/mL × hr [1,968-3,760] vs 2,680 pg/mL × hr [2,090-3,570] for EA-230 and placebo group, respectively; p = 0.80). Glomerular filtration rate increased following surgery (mean ± sem increase in the EA-230 vs placebo groups: glomerular filtration rateiohexol measured using iohexol plasma clearance: 19 ± 2 vs 16 ± 2 mL/min/1.73 m2; p = 0.13 and estimated glomerular filtration rate with the Modification of Diet in Renal Disease equation using creatinine: 6 ± 1 vs 2 ± 1 mL/min/1.73 m2; p = 0.01). The ""injury"" stage of the Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease criteria for acute kidney injury was 7% in the EA-230 group versus 18% in the placebo group (p = 0.07). In addition, EA-230-treated patients had a less positive fluid balance compared with placebo-treated patients (217 ± 108 vs 605 ± 103 mL; p = 0.01), while the use of vasoactive agents was similar in both groups (p = 0.39). Finally, hospital length of stay was shorter in EA-230 treated patients (8 d [7-11] vs 10 d [8-12]; p = 0.001). Efficacy results were more pronounced in patients that had longer duration of surgery and thus longer duration of study drug infusion. CONCLUSIONS EA-230 was safe in patients undergoing on-pump cardiac surgery. It did not modulate interleukin-6 plasma concentrations but appeared to exert beneficial renal and cardiovascular effects and shortened in-hospital length of stay.",2021,Glomerular filtration rate increased following surgery (mean ± SEM increase in the EA-230 vs placebo groups: glomerular filtration rateiohexol measured using iohexol plasma clearance: 19 ± 2 vs 16 ± 2 mL/min/1.73 m2; p = 0.13 and estimated glomerular filtration rate with the Modification of Diet in Renal Disease equation using creatinine: 6 ± 1 vs 2 ± 1 mL/min/1.73 m2; p = 0.01).,"['cardiac surgery patients', 'Collaboration of the Cardiothoracic Surgery, Anesthesiology, and the Intensive Care departments of a tertiary hospital in the Netherlands', 'One hundred eighty patients undergoing an on-pump coronary artery bypass procedure with or without concomitant valve surgery', 'patients undergoing on-pump cardiac surgery', 'Cardiac Surgery Patients']","['placebo', 'Human Chorionic Gonadotropin Hormone-Derivative EA-230', 'EA-230 and placebo', 'EA-230 or placebo', 'human chorionic gonadotropin hormone-derivative EA-230', 'Placebo']","['interleukin-6 plasma concentrations', 'hospital length of stay', 'Glomerular filtration rate', 'safety and efficacy', 'glomerular filtration rate', 'glomerular filtration rateiohexol', 'positive fluid balance', 'Safety and Efficacy']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1274037', 'cui_str': 'Cardiothoracic surgery'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C4079739', 'cui_str': 'EA-230'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0232809', 'cui_str': 'Glomerular filtration'}, {'cui': 'C2364300', 'cui_str': 'Positive fluid balance'}]",180.0,0.573229,Glomerular filtration rate increased following surgery (mean ± SEM increase in the EA-230 vs placebo groups: glomerular filtration rateiohexol measured using iohexol plasma clearance: 19 ± 2 vs 16 ± 2 mL/min/1.73 m2; p = 0.13 and estimated glomerular filtration rate with the Modification of Diet in Renal Disease equation using creatinine: 6 ± 1 vs 2 ± 1 mL/min/1.73 m2; p = 0.01).,"[{'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'van Groenendael', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Remi', 'Initials': 'R', 'LastName': 'Beunders', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Pleun', 'Initials': 'P', 'LastName': 'Hemelaar', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hofland', 'Affiliation': 'Department of Anesthesiology, Pain and Palliative Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Wim J', 'Initials': 'WJ', 'LastName': 'Morshuis', 'Affiliation': 'Department of Cardiothoracic Surgery, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Johannes G', 'Initials': 'JG', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Jelle', 'Initials': 'J', 'LastName': 'Gerretsen', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Wensvoort', 'Affiliation': 'Exponential Biotherapies, Inc. (EBI), The Hague, The Netherlands.'}, {'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Kooistra', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Wout J', 'Initials': 'WJ', 'LastName': 'Claassen', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Waanders', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Maud G A', 'Initials': 'MGA', 'LastName': 'Lamberts', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Leonie S E', 'Initials': 'LSE', 'LastName': 'Buijsse', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Kox', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Lucas T', 'Initials': 'LT', 'LastName': 'van Eijk', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Pickkers', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}]",Critical care medicine,['10.1097/CCM.0000000000004847'] 2118,33591004,von Willebrand Factor Multimer Formation Contributes to Immunothrombosis in Coronavirus Disease 2019.,"OBJECTIVES Prevention and therapy of immunothrombosis remain crucial challenges in the management of coronavirus disease 2019, since the underlying mechanisms are incompletely understood. We hypothesized that endothelial damage may lead to substantially increased concentrations of von Willebrand factor with subsequent relative deficiency of a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 (ADAMTS13). DESIGN Prospective controlled cross-over trial. SETTING Blood samples of patients with confirmed coronavirus disease 2019 and healthy controls were obtained in three German hospitals and analyzed in a German hemostaseologic laboratory. PATIENTS Seventy-five patients with confirmed coronavirus disease 2019 of mild to critical severity and 30 healthy controls. MEASUREMENTS AND MAIN RESULTS von Willebrand factor antigen, ADAMTS13, and von Willebrand factor multimer formation were analyzed. von Willebrand factor antigen was 4.1 times higher in COVID-19 patients compared with healthy controls (p < 0.0001), whereas ADAMTS13 activities were not significantly different (p = 0.18). The ADAMTS13/von Willebrand factor antigen ratio was significantly lower in COVID-19 than in the control group (24.4 ± 20.5 vs 82.0 ± 30.7; p < 0.0001). Fourteen patients (18.7%) undercut a critical ratio of 10 as described in thrombotic thrombocytopenic purpura. Gel analysis of multimers resembled a thrombotic thrombocytopenic purpura pattern with loss of the largest multimers in 75% and a smeary triplet pattern in 39% of the patients. The ADAMTS13/von Willebrand factor antigen ratio decreased continuously from mild to critical disease (analysis of variance p = 0.026). Furthermore, it differed significantly between surviving patients and those who died from COVID-19 (p = 0.001) yielding an area under the curve of 0.232 in receiver operating characteristic curve curve analysis. CONCLUSION COVID-19 is associated with a substantial increase in von Willebrand factor levels, which can exceed the ADAMTS13 processing capacity resulting in the formation of large von Willebrand factor multimers indistinguishable from thrombotic thrombocytopenic purpura. The ADAMTS13/von Willebrand factor antigen ratio is an independent predictor of severity of disease and mortality. These findings provide a rationale to consider plasma exchange as a therapeutic option in COVID-19 and to include von Willebrand factor and ADAMTS13 in the diagnostic workup.",2021,The ADAMTS13/von Willebrand factor antigen ratio was significantly lower in COVID-19 than in the control group (24.4 ± 20.5 vs 82.0 ± 30.7; p < 0.0001).,"['patients with confirmed coronavirus disease 2019 and healthy controls were obtained in three German hospitals and analyzed in a German hemostaseologic laboratory', 'Seventy-five patients with confirmed coronavirus disease 2019 of mild to critical severity and 30 healthy controls']",['ADAMTS13'],"['thrombotic thrombocytopenic purpura', 'ADAMTS13/von Willebrand factor antigen ratio', 'activities', 'von Willebrand factor antigen', 'von Willebrand factor antigen, ADAMTS13, and von Willebrand factor multimer formation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",[],"[{'cui': 'C0034155', 'cui_str': 'Thrombotic thrombocytopenic purpura'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0370148', 'cui_str': 'von Willebrand factor multimer'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",75.0,0.0414936,The ADAMTS13/von Willebrand factor antigen ratio was significantly lower in COVID-19 than in the control group (24.4 ± 20.5 vs 82.0 ± 30.7; p < 0.0001).,"[{'ForeName': 'Adrian A N', 'Initials': 'AAN', 'LastName': 'Doevelaar', 'Affiliation': 'Medical Department I, University Hospital Marien Hospital Herne, Ruhr-University Bochum, Herne, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bachmann', 'Affiliation': 'Department of Intensive Care and Ventilatory Medicine, Asklepios Klinikum Hamburg Harburg, Hamburg, Germany.'}, {'ForeName': 'Bodo', 'Initials': 'B', 'LastName': 'Hölzer', 'Affiliation': 'Medical Department I, University Hospital Marien Hospital Herne, Ruhr-University Bochum, Herne, Germany.'}, {'ForeName': 'Felix S', 'Initials': 'FS', 'LastName': 'Seibert', 'Affiliation': 'Medical Department I, University Hospital Marien Hospital Herne, Ruhr-University Bochum, Herne, Germany.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Rohn', 'Affiliation': 'Medical Department I, University Hospital Marien Hospital Herne, Ruhr-University Bochum, Herne, Germany.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Bauer', 'Affiliation': 'Medical Department I, University Hospital Marien Hospital Herne, Ruhr-University Bochum, Herne, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Witzke', 'Affiliation': 'Department of Infectiology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Dittmer', 'Affiliation': 'Department of Virology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bachmann', 'Affiliation': 'Department of Microbiology and Molecular Genetics, Michigan State University, East Lansing, MI.'}, {'ForeName': 'Serap', 'Initials': 'S', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Intensive Care and Ventilatory Medicine, Asklepios Klinikum Hamburg Harburg, Hamburg, Germany.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Dittmer', 'Affiliation': 'Department of Hemostaseology, MEDILYS Laborgesellschaft mbH, Hamburg, Germany.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Schneppenheim', 'Affiliation': 'Department of Hemostaseology, MEDILYS Laborgesellschaft mbH, Hamburg, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Babel', 'Affiliation': 'Medical Department I, University Hospital Marien Hospital Herne, Ruhr-University Bochum, Herne, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Budde', 'Affiliation': 'Department of Hemostaseology, MEDILYS Laborgesellschaft mbH, Hamburg, Germany.'}, {'ForeName': 'Timm H', 'Initials': 'TH', 'LastName': 'Westhoff', 'Affiliation': 'Medical Department I, University Hospital Marien Hospital Herne, Ruhr-University Bochum, Herne, Germany.'}]",Critical care medicine,['10.1097/CCM.0000000000004918'] 2119,33590999,The Impact of Preintubation Noninvasive Ventilation on Outcomes in Pediatric Acute Respiratory Distress Syndrome.,"OBJECTIVES There is evidence that noninvasive ventilation decreases the need for invasive mechanical ventilation. However, children with pediatric acute respiratory distress syndrome who fail noninvasive ventilation may have worse outcomes than those who are intubated without exposure to noninvasive ventilation. Our objective was to evaluate the impact of preintubation noninvasive ventilation on children with pediatric acute respiratory distress syndrome. DESIGN Secondary analysis of data from the Randomized Evaluation of Sedation Titration for Respiratory Failure trial. SETTING Thirty-one PICUs in the United States. PATIENTS Children 2 weeks to 17 years old with pediatric acute respiratory distress syndrome receiving invasive mechanical ventilation, excluding those admitted with tracheostomies. INTERVENTIONS None. MEASUREMENTS AND MAIN RESULTS Of 2,427 subjects receiving invasive mechanical ventilation, preintubation noninvasive ventilation was used in 995 (41%). Compared with subjects without preintubation noninvasive ventilation use, subjects with preintubation noninvasive ventilation use were more likely to have a history of seizures (10% vs 8%; p = 0.04) or cancer (11% vs 6%; p < 0.001) and have moderate or severe pediatric acute respiratory distress syndrome by the end of their first full day of invasive mechanical ventilation (68% vs 60%; p < 0.001). Adjusting for age, severity of illness on PICU admission, and baseline functional status, preintubation noninvasive ventilation use resulted in longer invasive mechanical ventilation duration (median 7.0 vs 6.0 d), longer PICU (10.8 vs 8.9 d), and hospital (17 vs 14 d) lengths of stay, and higher 28-day (5% vs 4%) and 90-day (8% vs 5%) inhospital mortalities (all comparisons p < 0.001). Longer duration of noninvasive ventilation before intubation was associated with worse outcomes. CONCLUSIONS In children with pediatric acute respiratory distress syndrome, preintubation noninvasive ventilation use is associated with worse outcomes when compared with no preintubation noninvasive ventilation use. These data can be used to inform the design of clinical studies to evaluate best noninvasive ventilation practices in children with pediatric acute respiratory distress syndrome.",2021,"In children with pediatric acute respiratory distress syndrome, preintubation noninvasive ventilation use is associated with worse outcomes when compared with no preintubation noninvasive ventilation use.","['2,427 subjects receiving', 'children with pediatric acute respiratory distress syndrome', 'Thirty-one PICUs in the United States', 'Pediatric Acute Respiratory Distress Syndrome', 'Children 2 weeks to 17 years old with pediatric acute respiratory distress syndrome receiving invasive mechanical ventilation, excluding those admitted with tracheostomies']","['noninvasive ventilation', 'preintubation noninvasive ventilation', 'Preintubation Noninvasive Ventilation']","['longer PICU', 'history of seizures', 'inhospital mortalities', 'moderate or severe pediatric acute respiratory distress syndrome', 'invasive mechanical ventilation duration', 'Longer duration of noninvasive ventilation', 'invasive mechanical ventilation, preintubation noninvasive ventilation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}]","[{'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}]","[{'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}]",2427.0,0.134644,"In children with pediatric acute respiratory distress syndrome, preintubation noninvasive ventilation use is associated with worse outcomes when compared with no preintubation noninvasive ventilation use.","[{'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Kopp', 'Affiliation': ""Department of Pediatrics, Sacred Hearts Children's Hospital, Spokane, WA.""}, {'ForeName': 'Rainer G', 'Initials': 'RG', 'LastName': 'Gedeit', 'Affiliation': 'Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Asaro', 'Affiliation': 'Department of Pediatrics, University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Gwenn E', 'Initials': 'GE', 'LastName': 'McLaughlin', 'Affiliation': 'Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wypij', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Martha A Q', 'Initials': 'MAQ', 'LastName': 'Curley', 'Affiliation': ""Department of Pediatrics, Sacred Hearts Children's Hospital, Spokane, WA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Critical care medicine,['10.1097/CCM.0000000000004819'] 2120,33528922,Dexmedetomidine or Propofol for Sedation in Mechanically Ventilated Adults with Sepsis.,"BACKGROUND Guidelines currently recommend targeting light sedation with dexmedetomidine or propofol for adults receiving mechanical ventilation. Differences exist between these sedatives in arousability, immunity, and inflammation. Whether they affect outcomes differentially in mechanically ventilated adults with sepsis undergoing light sedation is unknown. METHODS In a multicenter, double-blind trial, we randomly assigned mechanically ventilated adults with sepsis to receive dexmedetomidine (0.2 to 1.5 μg per kilogram of body weight per hour) or propofol (5 to 50 μg per kilogram per minute), with doses adjusted by bedside nurses to achieve target sedation goals set by clinicians according to the Richmond Agitation-Sedation Scale (RASS, on which scores range from -5 [unresponsive] to +4 [combative]). The primary end point was days alive without delirium or coma during the 14-day intervention period. Secondary end points were ventilator-free days at 28 days, death at 90 days, and age-adjusted total score on the Telephone Interview for Cognitive Status questionnaire (TICS-T; scores range from 0 to 100, with a mean of 50±10 and lower scores indicating worse cognition) at 6 months. RESULTS Of 432 patients who underwent randomization, 422 were assigned to receive a trial drug and were included in the analyses - 214 patients received dexmedetomidine at a median dose of 0.27 μg per kilogram per hour, and 208 received propofol at a median dose of 10.21 μg per kilogram per minute. The median duration of receipt of the trial drugs was 3.0 days (interquartile range, 2.0 to 6.0), and the median RASS score was -2.0 (interquartile range, -3.0 to -1.0). We found no difference between dexmedetomidine and propofol in the number of days alive without delirium or coma (adjusted median, 10.7 vs. 10.8 days; odds ratio, 0.96; 95% confidence interval [CI], 0.74 to 1.26), ventilator-free days (adjusted median, 23.7 vs. 24.0 days; odds ratio, 0.98; 95% CI, 0.63 to 1.51), death at 90 days (38% vs. 39%; hazard ratio, 1.06; 95% CI, 0.74 to 1.52), or TICS-T score at 6 months (adjusted median score, 40.9 vs. 41.4; odds ratio, 0.94; 95% CI, 0.66 to 1.33). Safety end points were similar in the two groups. CONCLUSIONS Among mechanically ventilated adults with sepsis who were being treated with recommended light-sedation approaches, outcomes in patients who received dexmedetomidine did not differ from outcomes in those who received propofol. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT01739933.).",2021,"We found no difference between dexmedetomidine and propofol in the number of days alive without delirium or coma (adjusted median, 10.7 vs. 10.8 days; odds ratio, 0.96; 95% confidence interval [CI], 0.74 to 1.26), ventilator-free days (adjusted median, 23.7 vs. 24.0 days; odds ratio, 0.98; 95% CI, 0.63 to 1.51), death at 90 days (38% vs. 39%; hazard ratio, 1.06; 95% CI, 0.74 to 1.52), or TICS-T score at 6 months (adjusted median score, 40.9 vs. 41.4; odds ratio, 0.94; 95% CI, 0.66 to 1.33).","['mechanically ventilated adults with sepsis', 'adults receiving mechanical ventilation', 'mechanically ventilated adults with sepsis to receive', 'mechanically ventilated adults with sepsis undergoing light sedation', '432 patients who underwent randomization', 'Mechanically Ventilated Adults with Sepsis']","['dexmedetomidine', 'Dexmedetomidine', 'propofol', 'dexmedetomidine or propofol', 'bedside nurses to achieve target sedation goals set by clinicians according to the Richmond Agitation-Sedation Scale (RASS', 'Propofol']","['median RASS score', 'median duration of receipt', 'TICS-T score', 'arousability, immunity, and inflammation', 'ventilator-free days at 28 days, death at 90 days, and age-adjusted total score on the Telephone Interview for Cognitive Status questionnaire (TICS-T; scores range', 'death', 'days alive without delirium or coma', 'number of days alive without delirium or coma']","[{'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040188', 'cui_str': 'Tic disorder'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0020964', 'cui_str': 'Immune status'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",432.0,0.620308,"We found no difference between dexmedetomidine and propofol in the number of days alive without delirium or coma (adjusted median, 10.7 vs. 10.8 days; odds ratio, 0.96; 95% confidence interval [CI], 0.74 to 1.26), ventilator-free days (adjusted median, 23.7 vs. 24.0 days; odds ratio, 0.98; 95% CI, 0.63 to 1.51), death at 90 days (38% vs. 39%; hazard ratio, 1.06; 95% CI, 0.74 to 1.52), or TICS-T score at 6 months (adjusted median score, 40.9 vs. 41.4; odds ratio, 0.94; 95% CI, 0.66 to 1.33).","[{'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Hughes', 'Affiliation': 'From the Critical Illness, Brain Dysfunction, and Survivorship Center (C.G.H., J.C.J., A.S.H., B.T.P., O.M.O., R.R., J.L.S., A.L.K, M.B.P., N.E.B., T.D.G., R.S.D., G.R.B., E.W.E., P.P.P.), the Center for Health Services Research (C.G.H., J.C.J., R.R., M.B.P., T.D.G., R.S.D., E.W.E., P.P.P.), the Division of Anesthesiology Critical Care Medicine, Department of Anesthesiology (C.G.H., P.P.P.), the Division of Allergy, Pulmonary, and Critical Care Medicine (J.C.J., B.T.P., G.R.B., E.W.E.), and the Division of General Internal Medicine and Public Health (R.S.D.), Department of Medicine, the Departments of Biostatistics (O.M.O., R.R.) and Pharmaceutical Services (J.L.S.), and Division of Trauma and Surgical Critical Care, Department of Surgery (M.B.P.), Vanderbilt University Medical Center, and the Anesthesia Service (C.G.H., P.P.P.), Research Service (J.C.J.), Surgical Service (M.B.P.), and Geriatric Research, Education and Clinical Center (R.S.D., E.W.E.), Department of Veterans Affairs Medical Center, Tennessee Valley Healthcare System - both in Nashville; the Neuroscience Institute and Department of Critical Care Medicine, Maine Medical Center, Portland (P.T.M.); the Department of Pharmacy and Health Systems Sciences, Bouve College of Health Sciences, Northeastern University, Boston (J.W.D., M.S.D.); the Departments of Pharmacy (J.T.S., L.N.B.) and Surgery (J.T.S.) and the Center for Outcomes Research (J.T.S.), Houston Methodist, and the Pulmonary, Critical Care and Sleep Medicine Section, Ben Taub Hospital, Baylor College of Medicine (K.K.G.), Houston; the Division of Pulmonary/Critical Care Medicine, University of Texas Health, and the South Texas Veterans Health Care System, San Antonio (A.A.); and Texas Health Harris Methodist Hospital Fort Worth, Fort Worth (A.S.) - all in Texas; the University of Sydney, and the Department of Anaesthetics, Royal Prince Alfred Hospital, Sydney, and the Department of Anesthesiology, University of Wisconsin, Madison (R.D.S.); Pulmonary and Critical Care Medicine, Baton Rouge General Medical Center and Our Lady of the Lake Regional Medical Center, Baton Rouge, LA (H.R.O.); the Department of Anesthesia and Perioperative Care, University of California, San Francisco, San Francisco (M.A.G.); Pulmonary and Critical Care, Mission Hospital, Asheville, NC (G.J.S.); the Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus (N.E.B.); and Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh (T.D.G.).'}, {'ForeName': 'Patrick T', 'Initials': 'PT', 'LastName': 'Mailloux', 'Affiliation': 'From the Critical Illness, Brain Dysfunction, and Survivorship Center (C.G.H., J.C.J., A.S.H., B.T.P., O.M.O., R.R., J.L.S., A.L.K, M.B.P., N.E.B., T.D.G., R.S.D., G.R.B., E.W.E., P.P.P.), the Center for Health Services Research (C.G.H., J.C.J., R.R., M.B.P., T.D.G., R.S.D., E.W.E., P.P.P.), the Division of Anesthesiology Critical Care Medicine, Department of Anesthesiology (C.G.H., P.P.P.), the Division of Allergy, Pulmonary, and Critical Care Medicine (J.C.J., B.T.P., G.R.B., E.W.E.), and the Division of General Internal Medicine and Public Health (R.S.D.), Department of Medicine, the Departments of Biostatistics (O.M.O., R.R.) and Pharmaceutical Services (J.L.S.), and Division of Trauma and Surgical Critical Care, Department of Surgery (M.B.P.), Vanderbilt University Medical Center, and the Anesthesia Service (C.G.H., P.P.P.), Research Service (J.C.J.), Surgical Service (M.B.P.), and Geriatric Research, Education and Clinical Center (R.S.D., E.W.E.), Department of Veterans Affairs Medical Center, Tennessee Valley Healthcare System - both in Nashville; the Neuroscience Institute and Department of Critical Care Medicine, Maine Medical Center, Portland (P.T.M.); the Department of Pharmacy and Health Systems Sciences, Bouve College of Health Sciences, Northeastern University, Boston (J.W.D., M.S.D.); the Departments of Pharmacy (J.T.S., L.N.B.) and Surgery (J.T.S.) and the Center for Outcomes Research (J.T.S.), Houston Methodist, and the Pulmonary, Critical Care and Sleep Medicine Section, Ben Taub Hospital, Baylor College of Medicine (K.K.G.), Houston; the Division of Pulmonary/Critical Care Medicine, University of Texas Health, and the South Texas Veterans Health Care System, San Antonio (A.A.); and Texas Health Harris Methodist Hospital Fort Worth, Fort Worth (A.S.) - all in Texas; the University of Sydney, and the Department of Anaesthetics, Royal Prince Alfred Hospital, Sydney, and the Department of Anesthesiology, University of Wisconsin, Madison (R.D.S.); Pulmonary and Critical Care Medicine, Baton Rouge General Medical Center and Our Lady of the Lake Regional Medical Center, Baton Rouge, LA (H.R.O.); the Department of Anesthesia and Perioperative Care, University of California, San Francisco, San Francisco (M.A.G.); Pulmonary and Critical Care, Mission Hospital, Asheville, NC (G.J.S.); the Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus (N.E.B.); and Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh (T.D.G.).'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Devlin', 'Affiliation': 'From the Critical Illness, Brain Dysfunction, and Survivorship Center (C.G.H., J.C.J., A.S.H., B.T.P., O.M.O., R.R., J.L.S., A.L.K, M.B.P., N.E.B., T.D.G., R.S.D., G.R.B., E.W.E., P.P.P.), the Center for Health Services Research (C.G.H., J.C.J., R.R., M.B.P., T.D.G., R.S.D., E.W.E., P.P.P.), the Division of Anesthesiology Critical Care Medicine, Department of Anesthesiology (C.G.H., P.P.P.), the Division of Allergy, Pulmonary, and Critical Care Medicine (J.C.J., B.T.P., G.R.B., E.W.E.), and the Division of General Internal Medicine and Public Health (R.S.D.), Department of Medicine, the Departments of Biostatistics (O.M.O., R.R.) and Pharmaceutical Services (J.L.S.), and Division of Trauma and Surgical Critical Care, Department of Surgery (M.B.P.), Vanderbilt University Medical Center, and the Anesthesia Service (C.G.H., P.P.P.), Research Service (J.C.J.), Surgical Service (M.B.P.), and Geriatric Research, Education and Clinical Center (R.S.D., E.W.E.), Department of Veterans Affairs Medical Center, Tennessee Valley Healthcare System - both in Nashville; the Neuroscience Institute and Department of Critical Care Medicine, Maine Medical Center, Portland (P.T.M.); the Department of Pharmacy and Health Systems Sciences, Bouve College of Health Sciences, Northeastern University, Boston (J.W.D., M.S.D.); the Departments of Pharmacy (J.T.S., L.N.B.) and Surgery (J.T.S.) and the Center for Outcomes Research (J.T.S.), Houston Methodist, and the Pulmonary, Critical Care and Sleep Medicine Section, Ben Taub Hospital, Baylor College of Medicine (K.K.G.), Houston; the Division of Pulmonary/Critical Care Medicine, University of Texas Health, and the South Texas Veterans Health Care System, San Antonio (A.A.); and Texas Health Harris Methodist Hospital Fort Worth, Fort Worth (A.S.) - all in Texas; the University of Sydney, and the Department of Anaesthetics, Royal Prince Alfred Hospital, Sydney, and the Department of Anesthesiology, University of Wisconsin, Madison (R.D.S.); Pulmonary and Critical Care Medicine, Baton Rouge General Medical Center and Our Lady of the Lake Regional Medical Center, Baton Rouge, LA (H.R.O.); the Department of Anesthesia and Perioperative Care, University of California, San Francisco, San Francisco (M.A.G.); Pulmonary and Critical Care, Mission Hospital, Asheville, NC (G.J.S.); the Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus (N.E.B.); and Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh (T.D.G.).'}, {'ForeName': 'Joshua T', 'Initials': 'JT', 'LastName': 'Swan', 'Affiliation': 'From the Critical Illness, Brain Dysfunction, and Survivorship Center (C.G.H., J.C.J., A.S.H., B.T.P., O.M.O., R.R., J.L.S., A.L.K, M.B.P., N.E.B., T.D.G., R.S.D., G.R.B., E.W.E., P.P.P.), the Center for Health Services Research (C.G.H., J.C.J., R.R., M.B.P., T.D.G., R.S.D., E.W.E., P.P.P.), the Division of Anesthesiology Critical Care Medicine, Department of Anesthesiology (C.G.H., P.P.P.), the Division of Allergy, Pulmonary, and Critical Care Medicine (J.C.J., B.T.P., G.R.B., E.W.E.), and the Division of General Internal Medicine and Public Health (R.S.D.), Department of Medicine, the Departments of Biostatistics (O.M.O., R.R.) and Pharmaceutical Services (J.L.S.), and Division of Trauma and Surgical Critical Care, Department of Surgery (M.B.P.), Vanderbilt University Medical Center, and the Anesthesia Service (C.G.H., P.P.P.), Research Service (J.C.J.), Surgical Service (M.B.P.), and Geriatric Research, Education and Clinical Center (R.S.D., E.W.E.), Department of Veterans Affairs Medical Center, Tennessee Valley Healthcare System - both in Nashville; the Neuroscience Institute and Department of Critical Care Medicine, Maine Medical Center, Portland (P.T.M.); the Department of Pharmacy and Health Systems Sciences, Bouve College of Health Sciences, Northeastern University, Boston (J.W.D., M.S.D.); the Departments of Pharmacy (J.T.S., L.N.B.) and Surgery (J.T.S.) and the Center for Outcomes Research (J.T.S.), Houston Methodist, and the Pulmonary, Critical Care and Sleep Medicine Section, Ben Taub Hospital, Baylor College of Medicine (K.K.G.), Houston; the Division of Pulmonary/Critical Care Medicine, University of Texas Health, and the South Texas Veterans Health Care System, San Antonio (A.A.); and Texas Health Harris Methodist Hospital Fort Worth, Fort Worth (A.S.) - all in Texas; the University of Sydney, and the Department of Anaesthetics, Royal Prince Alfred Hospital, Sydney, and the Department of Anesthesiology, University of Wisconsin, Madison (R.D.S.); Pulmonary and Critical Care Medicine, Baton Rouge General Medical Center and Our Lady of the Lake Regional Medical Center, Baton Rouge, LA (H.R.O.); the Department of Anesthesia and Perioperative Care, University of California, San Francisco, San Francisco (M.A.G.); Pulmonary and Critical Care, Mission Hospital, Asheville, NC (G.J.S.); the Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus (N.E.B.); and Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh (T.D.G.).'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Sanders', 'Affiliation': 'From the Critical Illness, Brain Dysfunction, and Survivorship Center (C.G.H., J.C.J., A.S.H., B.T.P., O.M.O., R.R., J.L.S., A.L.K, M.B.P., N.E.B., T.D.G., R.S.D., G.R.B., E.W.E., P.P.P.), the Center for Health Services Research (C.G.H., J.C.J., R.R., M.B.P., T.D.G., R.S.D., E.W.E., P.P.P.), the Division of Anesthesiology Critical Care Medicine, Department of Anesthesiology (C.G.H., P.P.P.), the Division of Allergy, Pulmonary, and Critical Care Medicine (J.C.J., B.T.P., G.R.B., E.W.E.), and the Division of General Internal Medicine and Public Health (R.S.D.), Department of Medicine, the Departments of Biostatistics (O.M.O., R.R.) and Pharmaceutical Services (J.L.S.), and Division of Trauma and Surgical Critical Care, Department of Surgery (M.B.P.), Vanderbilt University Medical Center, and the Anesthesia Service (C.G.H., P.P.P.), Research Service (J.C.J.), Surgical Service (M.B.P.), and Geriatric Research, Education and Clinical Center (R.S.D., E.W.E.), Department of Veterans Affairs Medical Center, Tennessee Valley Healthcare System - both in Nashville; the Neuroscience Institute and Department of Critical Care Medicine, Maine Medical Center, Portland (P.T.M.); the Department of Pharmacy and Health Systems Sciences, Bouve College of Health Sciences, Northeastern University, Boston (J.W.D., M.S.D.); the Departments of Pharmacy (J.T.S., L.N.B.) and Surgery (J.T.S.) and the Center for Outcomes Research (J.T.S.), Houston Methodist, and the Pulmonary, Critical Care and Sleep Medicine Section, Ben Taub Hospital, Baylor College of Medicine (K.K.G.), Houston; the Division of Pulmonary/Critical Care Medicine, University of Texas Health, and the South Texas Veterans Health Care System, San Antonio (A.A.); and Texas Health Harris Methodist Hospital Fort Worth, Fort Worth (A.S.) - all in Texas; the University of Sydney, and the Department of Anaesthetics, Royal Prince Alfred Hospital, Sydney, and the Department of Anesthesiology, University of Wisconsin, Madison (R.D.S.); Pulmonary and Critical Care Medicine, Baton Rouge General Medical Center and Our Lady of the Lake Regional Medical Center, Baton Rouge, LA (H.R.O.); the Department of Anesthesia and Perioperative Care, University of California, San Francisco, San Francisco (M.A.G.); Pulmonary and Critical Care, Mission Hospital, Asheville, NC (G.J.S.); the Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus (N.E.B.); and Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh (T.D.G.).'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Anzueto', 'Affiliation': 'From the Critical Illness, Brain Dysfunction, and Survivorship Center (C.G.H., J.C.J., A.S.H., B.T.P., O.M.O., R.R., J.L.S., A.L.K, M.B.P., N.E.B., T.D.G., R.S.D., G.R.B., E.W.E., P.P.P.), the Center for Health Services Research (C.G.H., J.C.J., R.R., M.B.P., T.D.G., R.S.D., E.W.E., P.P.P.), the Division of Anesthesiology Critical Care Medicine, Department of Anesthesiology (C.G.H., P.P.P.), the Division of Allergy, Pulmonary, and Critical Care Medicine (J.C.J., B.T.P., G.R.B., E.W.E.), and the Division of General Internal Medicine and Public Health (R.S.D.), Department of Medicine, the Departments of Biostatistics (O.M.O., R.R.) and Pharmaceutical Services (J.L.S.), and Division of Trauma and Surgical Critical Care, Department of Surgery (M.B.P.), Vanderbilt University Medical Center, and the Anesthesia Service (C.G.H., P.P.P.), Research Service (J.C.J.), Surgical Service (M.B.P.), and Geriatric Research, Education and Clinical Center (R.S.D., E.W.E.), Department of Veterans Affairs Medical Center, Tennessee Valley Healthcare System - both in Nashville; the Neuroscience Institute and Department of Critical Care Medicine, Maine Medical Center, Portland (P.T.M.); the Department of Pharmacy and Health Systems Sciences, Bouve College of Health Sciences, Northeastern University, Boston (J.W.D., M.S.D.); the Departments of Pharmacy (J.T.S., L.N.B.) and Surgery (J.T.S.) and the Center for Outcomes Research (J.T.S.), Houston Methodist, and the Pulmonary, Critical Care and Sleep Medicine Section, Ben Taub Hospital, Baylor College of Medicine (K.K.G.), Houston; the Division of Pulmonary/Critical Care Medicine, University of Texas Health, and the South Texas Veterans Health Care System, San Antonio (A.A.); and Texas Health Harris Methodist Hospital Fort Worth, Fort Worth (A.S.) - all in Texas; the University of Sydney, and the Department of Anaesthetics, Royal Prince Alfred Hospital, Sydney, and the Department of Anesthesiology, University of Wisconsin, Madison (R.D.S.); Pulmonary and Critical Care Medicine, Baton Rouge General Medical Center and Our Lady of the Lake Regional Medical Center, Baton Rouge, LA (H.R.O.); the Department of Anesthesia and Perioperative Care, University of California, San Francisco, San Francisco (M.A.G.); Pulmonary and Critical Care, Mission Hospital, Asheville, NC (G.J.S.); the Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus (N.E.B.); and Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh (T.D.G.).'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Jackson', 'Affiliation': 'From the Critical Illness, Brain Dysfunction, and Survivorship Center (C.G.H., J.C.J., A.S.H., B.T.P., O.M.O., R.R., J.L.S., A.L.K, M.B.P., N.E.B., T.D.G., R.S.D., G.R.B., E.W.E., P.P.P.), the Center for Health Services Research (C.G.H., J.C.J., R.R., M.B.P., T.D.G., R.S.D., E.W.E., P.P.P.), the Division of Anesthesiology Critical Care Medicine, Department of Anesthesiology (C.G.H., P.P.P.), the Division of Allergy, Pulmonary, and Critical Care Medicine (J.C.J., B.T.P., G.R.B., E.W.E.), and the Division of General Internal Medicine and Public Health (R.S.D.), Department of Medicine, the Departments of Biostatistics (O.M.O., R.R.) and Pharmaceutical Services (J.L.S.), and Division of Trauma and Surgical Critical Care, Department of Surgery (M.B.P.), Vanderbilt University Medical Center, and the Anesthesia Service (C.G.H., P.P.P.), Research Service (J.C.J.), Surgical Service (M.B.P.), and Geriatric Research, Education and Clinical Center (R.S.D., E.W.E.), Department of Veterans Affairs Medical Center, Tennessee Valley Healthcare System - both in Nashville; the Neuroscience Institute and Department of Critical Care Medicine, Maine Medical Center, Portland (P.T.M.); the Department of Pharmacy and Health Systems Sciences, Bouve College of Health Sciences, Northeastern University, Boston (J.W.D., M.S.D.); the Departments of Pharmacy (J.T.S., L.N.B.) and Surgery (J.T.S.) and the Center for Outcomes Research (J.T.S.), Houston Methodist, and the Pulmonary, Critical Care and Sleep Medicine Section, Ben Taub Hospital, Baylor College of Medicine (K.K.G.), Houston; the Division of Pulmonary/Critical Care Medicine, University of Texas Health, and the South Texas Veterans Health Care System, San Antonio (A.A.); and Texas Health Harris Methodist Hospital Fort Worth, Fort Worth (A.S.) - all in Texas; the University of Sydney, and the Department of Anaesthetics, Royal Prince Alfred Hospital, Sydney, and the Department of Anesthesiology, University of Wisconsin, Madison (R.D.S.); Pulmonary and Critical Care Medicine, Baton Rouge General Medical Center and Our Lady of the Lake Regional Medical Center, Baton Rouge, LA (H.R.O.); the Department of Anesthesia and Perioperative Care, University of California, San Francisco, San Francisco (M.A.G.); Pulmonary and Critical Care, Mission Hospital, Asheville, NC (G.J.S.); the Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus (N.E.B.); and Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh (T.D.G.).'}, {'ForeName': 'Aimee S', 'Initials': 'AS', 'LastName': 'Hoskins', 'Affiliation': 'From the Critical Illness, Brain Dysfunction, and Survivorship Center (C.G.H., J.C.J., A.S.H., B.T.P., O.M.O., R.R., J.L.S., A.L.K, M.B.P., N.E.B., T.D.G., R.S.D., G.R.B., E.W.E., P.P.P.), the Center for Health Services Research (C.G.H., J.C.J., R.R., M.B.P., T.D.G., R.S.D., E.W.E., P.P.P.), the Division of Anesthesiology Critical Care Medicine, Department of Anesthesiology (C.G.H., P.P.P.), the Division of Allergy, Pulmonary, and Critical Care Medicine (J.C.J., B.T.P., G.R.B., E.W.E.), and the Division of General Internal Medicine and Public Health (R.S.D.), Department of Medicine, the Departments of Biostatistics (O.M.O., R.R.) and Pharmaceutical Services (J.L.S.), and Division of Trauma and Surgical Critical Care, Department of Surgery (M.B.P.), Vanderbilt University Medical Center, and the Anesthesia Service (C.G.H., P.P.P.), Research Service (J.C.J.), Surgical Service (M.B.P.), and Geriatric Research, Education and Clinical Center (R.S.D., E.W.E.), Department of Veterans Affairs Medical Center, Tennessee Valley Healthcare System - both in Nashville; the Neuroscience Institute and Department of Critical Care Medicine, Maine Medical Center, Portland (P.T.M.); the Department of Pharmacy and Health Systems Sciences, Bouve College of Health Sciences, Northeastern University, Boston (J.W.D., M.S.D.); the Departments of Pharmacy (J.T.S., L.N.B.) and Surgery (J.T.S.) and the Center for Outcomes Research (J.T.S.), Houston Methodist, and the Pulmonary, Critical Care and Sleep Medicine Section, Ben Taub Hospital, Baylor College of Medicine (K.K.G.), Houston; the Division of Pulmonary/Critical Care Medicine, University of Texas Health, and the South Texas Veterans Health Care System, San Antonio (A.A.); and Texas Health Harris Methodist Hospital Fort Worth, Fort Worth (A.S.) - all in Texas; the University of Sydney, and the Department of Anaesthetics, Royal Prince Alfred Hospital, Sydney, and the Department of Anesthesiology, University of Wisconsin, Madison (R.D.S.); Pulmonary and Critical Care Medicine, Baton Rouge General Medical Center and Our Lady of the Lake Regional Medical Center, Baton Rouge, LA (H.R.O.); the Department of Anesthesia and Perioperative Care, University of California, San Francisco, San Francisco (M.A.G.); Pulmonary and Critical Care, Mission Hospital, Asheville, NC (G.J.S.); the Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus (N.E.B.); and Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh (T.D.G.).'}, {'ForeName': 'Brenda T', 'Initials': 'BT', 'LastName': 'Pun', 'Affiliation': 'From the Critical Illness, Brain Dysfunction, and Survivorship Center (C.G.H., J.C.J., A.S.H., B.T.P., O.M.O., R.R., J.L.S., A.L.K, M.B.P., N.E.B., T.D.G., R.S.D., G.R.B., E.W.E., P.P.P.), the Center for Health Services Research (C.G.H., J.C.J., R.R., M.B.P., T.D.G., R.S.D., E.W.E., P.P.P.), the Division of Anesthesiology Critical Care Medicine, Department of Anesthesiology (C.G.H., P.P.P.), the Division of Allergy, Pulmonary, and Critical Care Medicine (J.C.J., B.T.P., G.R.B., E.W.E.), and the Division of General Internal Medicine and Public Health (R.S.D.), Department of Medicine, the Departments of Biostatistics (O.M.O., R.R.) and Pharmaceutical Services (J.L.S.), and Division of Trauma and Surgical Critical Care, Department of Surgery (M.B.P.), Vanderbilt University Medical Center, and the Anesthesia Service (C.G.H., P.P.P.), Research Service (J.C.J.), Surgical Service (M.B.P.), and Geriatric Research, Education and Clinical Center (R.S.D., E.W.E.), Department of Veterans Affairs Medical Center, Tennessee Valley Healthcare System - both in Nashville; the Neuroscience Institute and Department of Critical Care Medicine, Maine Medical Center, Portland (P.T.M.); the Department of Pharmacy and Health Systems Sciences, Bouve College of Health Sciences, Northeastern University, Boston (J.W.D., M.S.D.); the Departments of Pharmacy (J.T.S., L.N.B.) and Surgery (J.T.S.) and the Center for Outcomes Research (J.T.S.), Houston Methodist, and the Pulmonary, Critical Care and Sleep Medicine Section, Ben Taub Hospital, Baylor College of Medicine (K.K.G.), Houston; the Division of Pulmonary/Critical Care Medicine, University of Texas Health, and the South Texas Veterans Health Care System, San Antonio (A.A.); and Texas Health Harris Methodist Hospital Fort Worth, Fort Worth (A.S.) - all in Texas; the University of Sydney, and the Department of Anaesthetics, Royal Prince Alfred Hospital, Sydney, and the Department of Anesthesiology, University of Wisconsin, Madison (R.D.S.); Pulmonary and Critical Care Medicine, Baton Rouge General Medical Center and Our Lady of the Lake Regional Medical Center, Baton Rouge, LA (H.R.O.); the Department of Anesthesia and Perioperative Care, University of California, San Francisco, San Francisco (M.A.G.); Pulmonary and Critical Care, Mission Hospital, Asheville, NC (G.J.S.); the Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus (N.E.B.); and Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh (T.D.G.).'}, {'ForeName': 'Onur M', 'Initials': 'OM', 'LastName': 'Orun', 'Affiliation': 'From the Critical Illness, Brain Dysfunction, and Survivorship Center (C.G.H., J.C.J., A.S.H., B.T.P., O.M.O., R.R., J.L.S., A.L.K, M.B.P., N.E.B., T.D.G., R.S.D., G.R.B., E.W.E., P.P.P.), the Center for Health Services Research (C.G.H., J.C.J., R.R., M.B.P., T.D.G., R.S.D., E.W.E., P.P.P.), the Division of Anesthesiology Critical Care Medicine, Department of Anesthesiology (C.G.H., P.P.P.), the Division of Allergy, Pulmonary, and Critical Care Medicine (J.C.J., B.T.P., G.R.B., E.W.E.), and the Division of General Internal Medicine and Public Health (R.S.D.), Department of Medicine, the Departments of Biostatistics (O.M.O., R.R.) and Pharmaceutical Services (J.L.S.), and Division of Trauma and Surgical Critical Care, Department of Surgery (M.B.P.), Vanderbilt University Medical Center, and the Anesthesia Service (C.G.H., P.P.P.), Research Service (J.C.J.), Surgical Service (M.B.P.), and Geriatric Research, Education and Clinical Center (R.S.D., E.W.E.), Department of Veterans Affairs Medical Center, Tennessee Valley Healthcare System - both in Nashville; the Neuroscience Institute and Department of Critical Care Medicine, Maine Medical Center, Portland (P.T.M.); the Department of Pharmacy and Health Systems Sciences, Bouve College of Health Sciences, Northeastern University, Boston (J.W.D., M.S.D.); the Departments of Pharmacy (J.T.S., L.N.B.) and Surgery (J.T.S.) and the Center for Outcomes Research (J.T.S.), Houston Methodist, and the Pulmonary, Critical Care and Sleep Medicine Section, Ben Taub Hospital, Baylor College of Medicine (K.K.G.), Houston; the Division of Pulmonary/Critical Care Medicine, University of Texas Health, and the South Texas Veterans Health Care System, San Antonio (A.A.); and Texas Health Harris Methodist Hospital Fort Worth, Fort Worth (A.S.) - all in Texas; the University of Sydney, and the Department of Anaesthetics, Royal Prince Alfred Hospital, Sydney, and the Department of Anesthesiology, University of Wisconsin, Madison (R.D.S.); Pulmonary and Critical Care Medicine, Baton Rouge General Medical Center and Our Lady of the Lake Regional Medical Center, Baton Rouge, LA (H.R.O.); the Department of Anesthesia and Perioperative Care, University of California, San Francisco, San Francisco (M.A.G.); Pulmonary and Critical Care, Mission Hospital, Asheville, NC (G.J.S.); the Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus (N.E.B.); and Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh (T.D.G.).'}, {'ForeName': 'Rameela', 'Initials': 'R', 'LastName': 'Raman', 'Affiliation': 'From the Critical Illness, Brain Dysfunction, and Survivorship Center (C.G.H., J.C.J., A.S.H., B.T.P., O.M.O., R.R., J.L.S., A.L.K, M.B.P., N.E.B., T.D.G., R.S.D., G.R.B., E.W.E., P.P.P.), the Center for Health Services Research (C.G.H., J.C.J., R.R., M.B.P., T.D.G., R.S.D., E.W.E., P.P.P.), the Division of Anesthesiology Critical Care Medicine, Department of Anesthesiology (C.G.H., P.P.P.), the Division of Allergy, Pulmonary, and Critical Care Medicine (J.C.J., B.T.P., G.R.B., E.W.E.), and the Division of General Internal Medicine and Public Health (R.S.D.), Department of Medicine, the Departments of Biostatistics (O.M.O., R.R.) and Pharmaceutical Services (J.L.S.), and Division of Trauma and Surgical Critical Care, Department of Surgery (M.B.P.), Vanderbilt University Medical Center, and the Anesthesia Service (C.G.H., P.P.P.), Research Service (J.C.J.), Surgical Service (M.B.P.), and Geriatric Research, Education and Clinical Center (R.S.D., E.W.E.), Department of Veterans Affairs Medical Center, Tennessee Valley Healthcare System - both in Nashville; the Neuroscience Institute and Department of Critical Care Medicine, Maine Medical Center, Portland (P.T.M.); the Department of Pharmacy and Health Systems Sciences, Bouve College of Health Sciences, Northeastern University, Boston (J.W.D., M.S.D.); the Departments of Pharmacy (J.T.S., L.N.B.) and Surgery (J.T.S.) and the Center for Outcomes Research (J.T.S.), Houston Methodist, and the Pulmonary, Critical Care and Sleep Medicine Section, Ben Taub Hospital, Baylor College of Medicine (K.K.G.), Houston; the Division of Pulmonary/Critical Care Medicine, University of Texas Health, and the South Texas Veterans Health Care System, San Antonio (A.A.); and Texas Health Harris Methodist Hospital Fort Worth, Fort Worth (A.S.) - all in Texas; the University of Sydney, and the Department of Anaesthetics, Royal Prince Alfred Hospital, Sydney, and the Department of Anesthesiology, University of Wisconsin, Madison (R.D.S.); Pulmonary and Critical Care Medicine, Baton Rouge General Medical Center and Our Lady of the Lake Regional Medical Center, Baton Rouge, LA (H.R.O.); the Department of Anesthesia and Perioperative Care, University of California, San Francisco, San Francisco (M.A.G.); Pulmonary and Critical Care, Mission Hospital, Asheville, NC (G.J.S.); the Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus (N.E.B.); and Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh (T.D.G.).'}, {'ForeName': 'Joanna L', 'Initials': 'JL', 'LastName': 'Stollings', 'Affiliation': 'From the Critical Illness, Brain Dysfunction, and Survivorship Center (C.G.H., J.C.J., A.S.H., B.T.P., O.M.O., R.R., J.L.S., A.L.K, M.B.P., N.E.B., T.D.G., R.S.D., G.R.B., E.W.E., P.P.P.), the Center for Health Services Research (C.G.H., J.C.J., R.R., M.B.P., T.D.G., R.S.D., E.W.E., P.P.P.), the Division of Anesthesiology Critical Care Medicine, Department of Anesthesiology (C.G.H., P.P.P.), the Division of Allergy, Pulmonary, and Critical Care Medicine (J.C.J., B.T.P., G.R.B., E.W.E.), and the Division of General Internal Medicine and Public Health (R.S.D.), Department of Medicine, the Departments of Biostatistics (O.M.O., R.R.) and Pharmaceutical Services (J.L.S.), and Division of Trauma and Surgical Critical Care, Department of Surgery (M.B.P.), Vanderbilt University Medical Center, and the Anesthesia Service (C.G.H., P.P.P.), Research Service (J.C.J.), Surgical Service (M.B.P.), and Geriatric Research, Education and Clinical Center (R.S.D., E.W.E.), Department of Veterans Affairs Medical Center, Tennessee Valley Healthcare System - both in Nashville; the Neuroscience Institute and Department of Critical Care Medicine, Maine Medical Center, Portland (P.T.M.); the Department of Pharmacy and Health Systems Sciences, Bouve College of Health Sciences, Northeastern University, Boston (J.W.D., M.S.D.); the Departments of Pharmacy (J.T.S., L.N.B.) and Surgery (J.T.S.) and the Center for Outcomes Research (J.T.S.), Houston Methodist, and the Pulmonary, Critical Care and Sleep Medicine Section, Ben Taub Hospital, Baylor College of Medicine (K.K.G.), Houston; the Division of Pulmonary/Critical Care Medicine, University of Texas Health, and the South Texas Veterans Health Care System, San Antonio (A.A.); and Texas Health Harris Methodist Hospital Fort Worth, Fort Worth (A.S.) - all in Texas; the University of Sydney, and the Department of Anaesthetics, Royal Prince Alfred Hospital, Sydney, and the Department of Anesthesiology, University of Wisconsin, Madison (R.D.S.); Pulmonary and Critical Care Medicine, Baton Rouge General Medical Center and Our Lady of the Lake Regional Medical Center, Baton Rouge, LA (H.R.O.); the Department of Anesthesia and Perioperative Care, University of California, San Francisco, San Francisco (M.A.G.); Pulmonary and Critical Care, Mission Hospital, Asheville, NC (G.J.S.); the Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus (N.E.B.); and Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh (T.D.G.).'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Kiehl', 'Affiliation': 'From the Critical Illness, Brain Dysfunction, and Survivorship Center (C.G.H., J.C.J., A.S.H., B.T.P., O.M.O., R.R., J.L.S., A.L.K, M.B.P., N.E.B., T.D.G., R.S.D., G.R.B., E.W.E., P.P.P.), the Center for Health Services Research (C.G.H., J.C.J., R.R., M.B.P., T.D.G., R.S.D., E.W.E., P.P.P.), the Division of Anesthesiology Critical Care Medicine, Department of Anesthesiology (C.G.H., P.P.P.), the Division of Allergy, Pulmonary, and Critical Care Medicine (J.C.J., B.T.P., G.R.B., E.W.E.), and the Division of General Internal Medicine and Public Health (R.S.D.), Department of Medicine, the Departments of Biostatistics (O.M.O., R.R.) and Pharmaceutical Services (J.L.S.), and Division of Trauma and Surgical Critical Care, Department of Surgery (M.B.P.), Vanderbilt University Medical Center, and the Anesthesia Service (C.G.H., P.P.P.), Research Service (J.C.J.), Surgical Service (M.B.P.), and Geriatric Research, Education and Clinical Center (R.S.D., E.W.E.), Department of Veterans Affairs Medical Center, Tennessee Valley Healthcare System - both in Nashville; the Neuroscience Institute and Department of Critical Care Medicine, Maine Medical Center, Portland (P.T.M.); the Department of Pharmacy and Health Systems Sciences, Bouve College of Health Sciences, Northeastern University, Boston (J.W.D., M.S.D.); the Departments of Pharmacy (J.T.S., L.N.B.) and Surgery (J.T.S.) and the Center for Outcomes Research (J.T.S.), Houston Methodist, and the Pulmonary, Critical Care and Sleep Medicine Section, Ben Taub Hospital, Baylor College of Medicine (K.K.G.), Houston; the Division of Pulmonary/Critical Care Medicine, University of Texas Health, and the South Texas Veterans Health Care System, San Antonio (A.A.); and Texas Health Harris Methodist Hospital Fort Worth, Fort Worth (A.S.) - all in Texas; the University of Sydney, and the Department of Anaesthetics, Royal Prince Alfred Hospital, Sydney, and the Department of Anesthesiology, University of Wisconsin, Madison (R.D.S.); Pulmonary and Critical Care Medicine, Baton Rouge General Medical Center and Our Lady of the Lake Regional Medical Center, Baton Rouge, LA (H.R.O.); the Department of Anesthesia and Perioperative Care, University of California, San Francisco, San Francisco (M.A.G.); Pulmonary and Critical Care, Mission Hospital, Asheville, NC (G.J.S.); the Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus (N.E.B.); and Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh (T.D.G.).'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Duprey', 'Affiliation': 'From the Critical Illness, Brain Dysfunction, and Survivorship Center (C.G.H., J.C.J., A.S.H., B.T.P., O.M.O., R.R., J.L.S., A.L.K, M.B.P., N.E.B., T.D.G., R.S.D., G.R.B., E.W.E., P.P.P.), the Center for Health Services Research (C.G.H., J.C.J., R.R., M.B.P., T.D.G., R.S.D., E.W.E., P.P.P.), the Division of Anesthesiology Critical Care Medicine, Department of Anesthesiology (C.G.H., P.P.P.), the Division of Allergy, Pulmonary, and Critical Care Medicine (J.C.J., B.T.P., G.R.B., E.W.E.), and the Division of General Internal Medicine and Public Health (R.S.D.), Department of Medicine, the Departments of Biostatistics (O.M.O., R.R.) and Pharmaceutical Services (J.L.S.), and Division of Trauma and Surgical Critical Care, Department of Surgery (M.B.P.), Vanderbilt University Medical Center, and the Anesthesia Service (C.G.H., P.P.P.), Research Service (J.C.J.), Surgical Service (M.B.P.), and Geriatric Research, Education and Clinical Center (R.S.D., E.W.E.), Department of Veterans Affairs Medical Center, Tennessee Valley Healthcare System - both in Nashville; the Neuroscience Institute and Department of Critical Care Medicine, Maine Medical Center, Portland (P.T.M.); the Department of Pharmacy and Health Systems Sciences, Bouve College of Health Sciences, Northeastern University, Boston (J.W.D., M.S.D.); the Departments of Pharmacy (J.T.S., L.N.B.) and Surgery (J.T.S.) and the Center for Outcomes Research (J.T.S.), Houston Methodist, and the Pulmonary, Critical Care and Sleep Medicine Section, Ben Taub Hospital, Baylor College of Medicine (K.K.G.), Houston; the Division of Pulmonary/Critical Care Medicine, University of Texas Health, and the South Texas Veterans Health Care System, San Antonio (A.A.); and Texas Health Harris Methodist Hospital Fort Worth, Fort Worth (A.S.) - all in Texas; the University of Sydney, and the Department of Anaesthetics, Royal Prince Alfred Hospital, Sydney, and the Department of Anesthesiology, University of Wisconsin, Madison (R.D.S.); Pulmonary and Critical Care Medicine, Baton Rouge General Medical Center and Our Lady of the Lake Regional Medical Center, Baton Rouge, LA (H.R.O.); the Department of Anesthesia and Perioperative Care, University of California, San Francisco, San Francisco (M.A.G.); Pulmonary and Critical Care, Mission Hospital, Asheville, NC (G.J.S.); the Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus (N.E.B.); and Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh (T.D.G.).'}, {'ForeName': 'Lan N', 'Initials': 'LN', 'LastName': 'Bui', 'Affiliation': 'From the Critical Illness, Brain Dysfunction, and Survivorship Center (C.G.H., J.C.J., A.S.H., B.T.P., O.M.O., R.R., J.L.S., A.L.K, M.B.P., N.E.B., T.D.G., R.S.D., G.R.B., E.W.E., P.P.P.), the Center for Health Services Research (C.G.H., J.C.J., R.R., M.B.P., T.D.G., R.S.D., E.W.E., P.P.P.), the Division of Anesthesiology Critical Care Medicine, Department of Anesthesiology (C.G.H., P.P.P.), the Division of Allergy, Pulmonary, and Critical Care Medicine (J.C.J., B.T.P., G.R.B., E.W.E.), and the Division of General Internal Medicine and Public Health (R.S.D.), Department of Medicine, the Departments of Biostatistics (O.M.O., R.R.) and Pharmaceutical Services (J.L.S.), and Division of Trauma and Surgical Critical Care, Department of Surgery (M.B.P.), Vanderbilt University Medical Center, and the Anesthesia Service (C.G.H., P.P.P.), Research Service (J.C.J.), Surgical Service (M.B.P.), and Geriatric Research, Education and Clinical Center (R.S.D., E.W.E.), Department of Veterans Affairs Medical Center, Tennessee Valley Healthcare System - both in Nashville; the Neuroscience Institute and Department of Critical Care Medicine, Maine Medical Center, Portland (P.T.M.); the Department of Pharmacy and Health Systems Sciences, Bouve College of Health Sciences, Northeastern University, Boston (J.W.D., M.S.D.); the Departments of Pharmacy (J.T.S., L.N.B.) and Surgery (J.T.S.) and the Center for Outcomes Research (J.T.S.), Houston Methodist, and the Pulmonary, Critical Care and Sleep Medicine Section, Ben Taub Hospital, Baylor College of Medicine (K.K.G.), Houston; the Division of Pulmonary/Critical Care Medicine, University of Texas Health, and the South Texas Veterans Health Care System, San Antonio (A.A.); and Texas Health Harris Methodist Hospital Fort Worth, Fort Worth (A.S.) - all in Texas; the University of Sydney, and the Department of Anaesthetics, Royal Prince Alfred Hospital, Sydney, and the Department of Anesthesiology, University of Wisconsin, Madison (R.D.S.); Pulmonary and Critical Care Medicine, Baton Rouge General Medical Center and Our Lady of the Lake Regional Medical Center, Baton Rouge, LA (H.R.O.); the Department of Anesthesia and Perioperative Care, University of California, San Francisco, San Francisco (M.A.G.); Pulmonary and Critical Care, Mission Hospital, Asheville, NC (G.J.S.); the Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus (N.E.B.); and Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh (T.D.G.).'}, {'ForeName': 'Hollis R', 'Initials': 'HR', 'LastName': ""O'Neal"", 'Affiliation': 'From the Critical Illness, Brain Dysfunction, and Survivorship Center (C.G.H., J.C.J., A.S.H., B.T.P., O.M.O., R.R., J.L.S., A.L.K, M.B.P., N.E.B., T.D.G., R.S.D., G.R.B., E.W.E., P.P.P.), the Center for Health Services Research (C.G.H., J.C.J., R.R., M.B.P., T.D.G., R.S.D., E.W.E., P.P.P.), the Division of Anesthesiology Critical Care Medicine, Department of Anesthesiology (C.G.H., P.P.P.), the Division of Allergy, Pulmonary, and Critical Care Medicine (J.C.J., B.T.P., G.R.B., E.W.E.), and the Division of General Internal Medicine and Public Health (R.S.D.), Department of Medicine, the Departments of Biostatistics (O.M.O., R.R.) and Pharmaceutical Services (J.L.S.), and Division of Trauma and Surgical Critical Care, Department of Surgery (M.B.P.), Vanderbilt University Medical Center, and the Anesthesia Service (C.G.H., P.P.P.), Research Service (J.C.J.), Surgical Service (M.B.P.), and Geriatric Research, Education and Clinical Center (R.S.D., E.W.E.), Department of Veterans Affairs Medical Center, Tennessee Valley Healthcare System - both in Nashville; the Neuroscience Institute and Department of Critical Care Medicine, Maine Medical Center, Portland (P.T.M.); the Department of Pharmacy and Health Systems Sciences, Bouve College of Health Sciences, Northeastern University, Boston (J.W.D., M.S.D.); the Departments of Pharmacy (J.T.S., L.N.B.) and Surgery (J.T.S.) and the Center for Outcomes Research (J.T.S.), Houston Methodist, and the Pulmonary, Critical Care and Sleep Medicine Section, Ben Taub Hospital, Baylor College of Medicine (K.K.G.), Houston; the Division of Pulmonary/Critical Care Medicine, University of Texas Health, and the South Texas Veterans Health Care System, San Antonio (A.A.); and Texas Health Harris Methodist Hospital Fort Worth, Fort Worth (A.S.) - all in Texas; the University of Sydney, and the Department of Anaesthetics, Royal Prince Alfred Hospital, Sydney, and the Department of Anesthesiology, University of Wisconsin, Madison (R.D.S.); Pulmonary and Critical Care Medicine, Baton Rouge General Medical Center and Our Lady of the Lake Regional Medical Center, Baton Rouge, LA (H.R.O.); the Department of Anesthesia and Perioperative Care, University of California, San Francisco, San Francisco (M.A.G.); Pulmonary and Critical Care, Mission Hospital, Asheville, NC (G.J.S.); the Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus (N.E.B.); and Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh (T.D.G.).'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Snyder', 'Affiliation': 'From the Critical Illness, Brain Dysfunction, and Survivorship Center (C.G.H., J.C.J., A.S.H., B.T.P., O.M.O., R.R., J.L.S., A.L.K, M.B.P., N.E.B., T.D.G., R.S.D., G.R.B., E.W.E., P.P.P.), the Center for Health Services Research (C.G.H., J.C.J., R.R., M.B.P., T.D.G., R.S.D., E.W.E., P.P.P.), the Division of Anesthesiology Critical Care Medicine, Department of Anesthesiology (C.G.H., P.P.P.), the Division of Allergy, Pulmonary, and Critical Care Medicine (J.C.J., B.T.P., G.R.B., E.W.E.), and the Division of General Internal Medicine and Public Health (R.S.D.), Department of Medicine, the Departments of Biostatistics (O.M.O., R.R.) and Pharmaceutical Services (J.L.S.), and Division of Trauma and Surgical Critical Care, Department of Surgery (M.B.P.), Vanderbilt University Medical Center, and the Anesthesia Service (C.G.H., P.P.P.), Research Service (J.C.J.), Surgical Service (M.B.P.), and Geriatric Research, Education and Clinical Center (R.S.D., E.W.E.), Department of Veterans Affairs Medical Center, Tennessee Valley Healthcare System - both in Nashville; the Neuroscience Institute and Department of Critical Care Medicine, Maine Medical Center, Portland (P.T.M.); the Department of Pharmacy and Health Systems Sciences, Bouve College of Health Sciences, Northeastern University, Boston (J.W.D., M.S.D.); the Departments of Pharmacy (J.T.S., L.N.B.) and Surgery (J.T.S.) and the Center for Outcomes Research (J.T.S.), Houston Methodist, and the Pulmonary, Critical Care and Sleep Medicine Section, Ben Taub Hospital, Baylor College of Medicine (K.K.G.), Houston; the Division of Pulmonary/Critical Care Medicine, University of Texas Health, and the South Texas Veterans Health Care System, San Antonio (A.A.); and Texas Health Harris Methodist Hospital Fort Worth, Fort Worth (A.S.) - all in Texas; the University of Sydney, and the Department of Anaesthetics, Royal Prince Alfred Hospital, Sydney, and the Department of Anesthesiology, University of Wisconsin, Madison (R.D.S.); Pulmonary and Critical Care Medicine, Baton Rouge General Medical Center and Our Lady of the Lake Regional Medical Center, Baton Rouge, LA (H.R.O.); the Department of Anesthesia and Perioperative Care, University of California, San Francisco, San Francisco (M.A.G.); Pulmonary and Critical Care, Mission Hospital, Asheville, NC (G.J.S.); the Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus (N.E.B.); and Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh (T.D.G.).'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Gropper', 'Affiliation': 'From the Critical Illness, Brain Dysfunction, and Survivorship Center (C.G.H., J.C.J., A.S.H., B.T.P., O.M.O., R.R., J.L.S., A.L.K, M.B.P., N.E.B., T.D.G., R.S.D., G.R.B., E.W.E., P.P.P.), the Center for Health Services Research (C.G.H., J.C.J., R.R., M.B.P., T.D.G., R.S.D., E.W.E., P.P.P.), the Division of Anesthesiology Critical Care Medicine, Department of Anesthesiology (C.G.H., P.P.P.), the Division of Allergy, Pulmonary, and Critical Care Medicine (J.C.J., B.T.P., G.R.B., E.W.E.), and the Division of General Internal Medicine and Public Health (R.S.D.), Department of Medicine, the Departments of Biostatistics (O.M.O., R.R.) and Pharmaceutical Services (J.L.S.), and Division of Trauma and Surgical Critical Care, Department of Surgery (M.B.P.), Vanderbilt University Medical Center, and the Anesthesia Service (C.G.H., P.P.P.), Research Service (J.C.J.), Surgical Service (M.B.P.), and Geriatric Research, Education and Clinical Center (R.S.D., E.W.E.), Department of Veterans Affairs Medical Center, Tennessee Valley Healthcare System - both in Nashville; the Neuroscience Institute and Department of Critical Care Medicine, Maine Medical Center, Portland (P.T.M.); the Department of Pharmacy and Health Systems Sciences, Bouve College of Health Sciences, Northeastern University, Boston (J.W.D., M.S.D.); the Departments of Pharmacy (J.T.S., L.N.B.) and Surgery (J.T.S.) and the Center for Outcomes Research (J.T.S.), Houston Methodist, and the Pulmonary, Critical Care and Sleep Medicine Section, Ben Taub Hospital, Baylor College of Medicine (K.K.G.), Houston; the Division of Pulmonary/Critical Care Medicine, University of Texas Health, and the South Texas Veterans Health Care System, San Antonio (A.A.); and Texas Health Harris Methodist Hospital Fort Worth, Fort Worth (A.S.) - all in Texas; the University of Sydney, and the Department of Anaesthetics, Royal Prince Alfred Hospital, Sydney, and the Department of Anesthesiology, University of Wisconsin, Madison (R.D.S.); Pulmonary and Critical Care Medicine, Baton Rouge General Medical Center and Our Lady of the Lake Regional Medical Center, Baton Rouge, LA (H.R.O.); the Department of Anesthesia and Perioperative Care, University of California, San Francisco, San Francisco (M.A.G.); Pulmonary and Critical Care, Mission Hospital, Asheville, NC (G.J.S.); the Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus (N.E.B.); and Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh (T.D.G.).'}, {'ForeName': 'Kalpalatha K', 'Initials': 'KK', 'LastName': 'Guntupalli', 'Affiliation': 'From the Critical Illness, Brain Dysfunction, and Survivorship Center (C.G.H., J.C.J., A.S.H., B.T.P., O.M.O., R.R., J.L.S., A.L.K, M.B.P., N.E.B., T.D.G., R.S.D., G.R.B., E.W.E., P.P.P.), the Center for Health Services Research (C.G.H., J.C.J., R.R., M.B.P., T.D.G., R.S.D., E.W.E., P.P.P.), the Division of Anesthesiology Critical Care Medicine, Department of Anesthesiology (C.G.H., P.P.P.), the Division of Allergy, Pulmonary, and Critical Care Medicine (J.C.J., B.T.P., G.R.B., E.W.E.), and the Division of General Internal Medicine and Public Health (R.S.D.), Department of Medicine, the Departments of Biostatistics (O.M.O., R.R.) and Pharmaceutical Services (J.L.S.), and Division of Trauma and Surgical Critical Care, Department of Surgery (M.B.P.), Vanderbilt University Medical Center, and the Anesthesia Service (C.G.H., P.P.P.), Research Service (J.C.J.), Surgical Service (M.B.P.), and Geriatric Research, Education and Clinical Center (R.S.D., E.W.E.), Department of Veterans Affairs Medical Center, Tennessee Valley Healthcare System - both in Nashville; the Neuroscience Institute and Department of Critical Care Medicine, Maine Medical Center, Portland (P.T.M.); the Department of Pharmacy and Health Systems Sciences, Bouve College of Health Sciences, Northeastern University, Boston (J.W.D., M.S.D.); the Departments of Pharmacy (J.T.S., L.N.B.) and Surgery (J.T.S.) and the Center for Outcomes Research (J.T.S.), Houston Methodist, and the Pulmonary, Critical Care and Sleep Medicine Section, Ben Taub Hospital, Baylor College of Medicine (K.K.G.), Houston; the Division of Pulmonary/Critical Care Medicine, University of Texas Health, and the South Texas Veterans Health Care System, San Antonio (A.A.); and Texas Health Harris Methodist Hospital Fort Worth, Fort Worth (A.S.) - all in Texas; the University of Sydney, and the Department of Anaesthetics, Royal Prince Alfred Hospital, Sydney, and the Department of Anesthesiology, University of Wisconsin, Madison (R.D.S.); Pulmonary and Critical Care Medicine, Baton Rouge General Medical Center and Our Lady of the Lake Regional Medical Center, Baton Rouge, LA (H.R.O.); the Department of Anesthesia and Perioperative Care, University of California, San Francisco, San Francisco (M.A.G.); Pulmonary and Critical Care, Mission Hospital, Asheville, NC (G.J.S.); the Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus (N.E.B.); and Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh (T.D.G.).'}, {'ForeName': 'Gregg J', 'Initials': 'GJ', 'LastName': 'Stashenko', 'Affiliation': 'From the Critical Illness, Brain Dysfunction, and Survivorship Center (C.G.H., J.C.J., A.S.H., B.T.P., O.M.O., R.R., J.L.S., A.L.K, M.B.P., N.E.B., T.D.G., R.S.D., G.R.B., E.W.E., P.P.P.), the Center for Health Services Research (C.G.H., J.C.J., R.R., M.B.P., T.D.G., R.S.D., E.W.E., P.P.P.), the Division of Anesthesiology Critical Care Medicine, Department of Anesthesiology (C.G.H., P.P.P.), the Division of Allergy, Pulmonary, and Critical Care Medicine (J.C.J., B.T.P., G.R.B., E.W.E.), and the Division of General Internal Medicine and Public Health (R.S.D.), Department of Medicine, the Departments of Biostatistics (O.M.O., R.R.) and Pharmaceutical Services (J.L.S.), and Division of Trauma and Surgical Critical Care, Department of Surgery (M.B.P.), Vanderbilt University Medical Center, and the Anesthesia Service (C.G.H., P.P.P.), Research Service (J.C.J.), Surgical Service (M.B.P.), and Geriatric Research, Education and Clinical Center (R.S.D., E.W.E.), Department of Veterans Affairs Medical Center, Tennessee Valley Healthcare System - both in Nashville; the Neuroscience Institute and Department of Critical Care Medicine, Maine Medical Center, Portland (P.T.M.); the Department of Pharmacy and Health Systems Sciences, Bouve College of Health Sciences, Northeastern University, Boston (J.W.D., M.S.D.); the Departments of Pharmacy (J.T.S., L.N.B.) and Surgery (J.T.S.) and the Center for Outcomes Research (J.T.S.), Houston Methodist, and the Pulmonary, Critical Care and Sleep Medicine Section, Ben Taub Hospital, Baylor College of Medicine (K.K.G.), Houston; the Division of Pulmonary/Critical Care Medicine, University of Texas Health, and the South Texas Veterans Health Care System, San Antonio (A.A.); and Texas Health Harris Methodist Hospital Fort Worth, Fort Worth (A.S.) - all in Texas; the University of Sydney, and the Department of Anaesthetics, Royal Prince Alfred Hospital, Sydney, and the Department of Anesthesiology, University of Wisconsin, Madison (R.D.S.); Pulmonary and Critical Care Medicine, Baton Rouge General Medical Center and Our Lady of the Lake Regional Medical Center, Baton Rouge, LA (H.R.O.); the Department of Anesthesia and Perioperative Care, University of California, San Francisco, San Francisco (M.A.G.); Pulmonary and Critical Care, Mission Hospital, Asheville, NC (G.J.S.); the Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus (N.E.B.); and Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh (T.D.G.).'}, {'ForeName': 'Mayur B', 'Initials': 'MB', 'LastName': 'Patel', 'Affiliation': 'From the Critical Illness, Brain Dysfunction, and Survivorship Center (C.G.H., J.C.J., A.S.H., B.T.P., O.M.O., R.R., J.L.S., A.L.K, M.B.P., N.E.B., T.D.G., R.S.D., G.R.B., E.W.E., P.P.P.), the Center for Health Services Research (C.G.H., J.C.J., R.R., M.B.P., T.D.G., R.S.D., E.W.E., P.P.P.), the Division of Anesthesiology Critical Care Medicine, Department of Anesthesiology (C.G.H., P.P.P.), the Division of Allergy, Pulmonary, and Critical Care Medicine (J.C.J., B.T.P., G.R.B., E.W.E.), and the Division of General Internal Medicine and Public Health (R.S.D.), Department of Medicine, the Departments of Biostatistics (O.M.O., R.R.) and Pharmaceutical Services (J.L.S.), and Division of Trauma and Surgical Critical Care, Department of Surgery (M.B.P.), Vanderbilt University Medical Center, and the Anesthesia Service (C.G.H., P.P.P.), Research Service (J.C.J.), Surgical Service (M.B.P.), and Geriatric Research, Education and Clinical Center (R.S.D., E.W.E.), Department of Veterans Affairs Medical Center, Tennessee Valley Healthcare System - both in Nashville; the Neuroscience Institute and Department of Critical Care Medicine, Maine Medical Center, Portland (P.T.M.); the Department of Pharmacy and Health Systems Sciences, Bouve College of Health Sciences, Northeastern University, Boston (J.W.D., M.S.D.); the Departments of Pharmacy (J.T.S., L.N.B.) and Surgery (J.T.S.) and the Center for Outcomes Research (J.T.S.), Houston Methodist, and the Pulmonary, Critical Care and Sleep Medicine Section, Ben Taub Hospital, Baylor College of Medicine (K.K.G.), Houston; the Division of Pulmonary/Critical Care Medicine, University of Texas Health, and the South Texas Veterans Health Care System, San Antonio (A.A.); and Texas Health Harris Methodist Hospital Fort Worth, Fort Worth (A.S.) - all in Texas; the University of Sydney, and the Department of Anaesthetics, Royal Prince Alfred Hospital, Sydney, and the Department of Anesthesiology, University of Wisconsin, Madison (R.D.S.); Pulmonary and Critical Care Medicine, Baton Rouge General Medical Center and Our Lady of the Lake Regional Medical Center, Baton Rouge, LA (H.R.O.); the Department of Anesthesia and Perioperative Care, University of California, San Francisco, San Francisco (M.A.G.); Pulmonary and Critical Care, Mission Hospital, Asheville, NC (G.J.S.); the Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus (N.E.B.); and Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh (T.D.G.).'}, {'ForeName': 'Nathan E', 'Initials': 'NE', 'LastName': 'Brummel', 'Affiliation': 'From the Critical Illness, Brain Dysfunction, and Survivorship Center (C.G.H., J.C.J., A.S.H., B.T.P., O.M.O., R.R., J.L.S., A.L.K, M.B.P., N.E.B., T.D.G., R.S.D., G.R.B., E.W.E., P.P.P.), the Center for Health Services Research (C.G.H., J.C.J., R.R., M.B.P., T.D.G., R.S.D., E.W.E., P.P.P.), the Division of Anesthesiology Critical Care Medicine, Department of Anesthesiology (C.G.H., P.P.P.), the Division of Allergy, Pulmonary, and Critical Care Medicine (J.C.J., B.T.P., G.R.B., E.W.E.), and the Division of General Internal Medicine and Public Health (R.S.D.), Department of Medicine, the Departments of Biostatistics (O.M.O., R.R.) and Pharmaceutical Services (J.L.S.), and Division of Trauma and Surgical Critical Care, Department of Surgery (M.B.P.), Vanderbilt University Medical Center, and the Anesthesia Service (C.G.H., P.P.P.), Research Service (J.C.J.), Surgical Service (M.B.P.), and Geriatric Research, Education and Clinical Center (R.S.D., E.W.E.), Department of Veterans Affairs Medical Center, Tennessee Valley Healthcare System - both in Nashville; the Neuroscience Institute and Department of Critical Care Medicine, Maine Medical Center, Portland (P.T.M.); the Department of Pharmacy and Health Systems Sciences, Bouve College of Health Sciences, Northeastern University, Boston (J.W.D., M.S.D.); the Departments of Pharmacy (J.T.S., L.N.B.) and Surgery (J.T.S.) and the Center for Outcomes Research (J.T.S.), Houston Methodist, and the Pulmonary, Critical Care and Sleep Medicine Section, Ben Taub Hospital, Baylor College of Medicine (K.K.G.), Houston; the Division of Pulmonary/Critical Care Medicine, University of Texas Health, and the South Texas Veterans Health Care System, San Antonio (A.A.); and Texas Health Harris Methodist Hospital Fort Worth, Fort Worth (A.S.) - all in Texas; the University of Sydney, and the Department of Anaesthetics, Royal Prince Alfred Hospital, Sydney, and the Department of Anesthesiology, University of Wisconsin, Madison (R.D.S.); Pulmonary and Critical Care Medicine, Baton Rouge General Medical Center and Our Lady of the Lake Regional Medical Center, Baton Rouge, LA (H.R.O.); the Department of Anesthesia and Perioperative Care, University of California, San Francisco, San Francisco (M.A.G.); Pulmonary and Critical Care, Mission Hospital, Asheville, NC (G.J.S.); the Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus (N.E.B.); and Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh (T.D.G.).'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Girard', 'Affiliation': 'From the Critical Illness, Brain Dysfunction, and Survivorship Center (C.G.H., J.C.J., A.S.H., B.T.P., O.M.O., R.R., J.L.S., A.L.K, M.B.P., N.E.B., T.D.G., R.S.D., G.R.B., E.W.E., P.P.P.), the Center for Health Services Research (C.G.H., J.C.J., R.R., M.B.P., T.D.G., R.S.D., E.W.E., P.P.P.), the Division of Anesthesiology Critical Care Medicine, Department of Anesthesiology (C.G.H., P.P.P.), the Division of Allergy, Pulmonary, and Critical Care Medicine (J.C.J., B.T.P., G.R.B., E.W.E.), and the Division of General Internal Medicine and Public Health (R.S.D.), Department of Medicine, the Departments of Biostatistics (O.M.O., R.R.) and Pharmaceutical Services (J.L.S.), and Division of Trauma and Surgical Critical Care, Department of Surgery (M.B.P.), Vanderbilt University Medical Center, and the Anesthesia Service (C.G.H., P.P.P.), Research Service (J.C.J.), Surgical Service (M.B.P.), and Geriatric Research, Education and Clinical Center (R.S.D., E.W.E.), Department of Veterans Affairs Medical Center, Tennessee Valley Healthcare System - both in Nashville; the Neuroscience Institute and Department of Critical Care Medicine, Maine Medical Center, Portland (P.T.M.); the Department of Pharmacy and Health Systems Sciences, Bouve College of Health Sciences, Northeastern University, Boston (J.W.D., M.S.D.); the Departments of Pharmacy (J.T.S., L.N.B.) and Surgery (J.T.S.) and the Center for Outcomes Research (J.T.S.), Houston Methodist, and the Pulmonary, Critical Care and Sleep Medicine Section, Ben Taub Hospital, Baylor College of Medicine (K.K.G.), Houston; the Division of Pulmonary/Critical Care Medicine, University of Texas Health, and the South Texas Veterans Health Care System, San Antonio (A.A.); and Texas Health Harris Methodist Hospital Fort Worth, Fort Worth (A.S.) - all in Texas; the University of Sydney, and the Department of Anaesthetics, Royal Prince Alfred Hospital, Sydney, and the Department of Anesthesiology, University of Wisconsin, Madison (R.D.S.); Pulmonary and Critical Care Medicine, Baton Rouge General Medical Center and Our Lady of the Lake Regional Medical Center, Baton Rouge, LA (H.R.O.); the Department of Anesthesia and Perioperative Care, University of California, San Francisco, San Francisco (M.A.G.); Pulmonary and Critical Care, Mission Hospital, Asheville, NC (G.J.S.); the Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus (N.E.B.); and Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh (T.D.G.).'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Dittus', 'Affiliation': 'From the Critical Illness, Brain Dysfunction, and Survivorship Center (C.G.H., J.C.J., A.S.H., B.T.P., O.M.O., R.R., J.L.S., A.L.K, M.B.P., N.E.B., T.D.G., R.S.D., G.R.B., E.W.E., P.P.P.), the Center for Health Services Research (C.G.H., J.C.J., R.R., M.B.P., T.D.G., R.S.D., E.W.E., P.P.P.), the Division of Anesthesiology Critical Care Medicine, Department of Anesthesiology (C.G.H., P.P.P.), the Division of Allergy, Pulmonary, and Critical Care Medicine (J.C.J., B.T.P., G.R.B., E.W.E.), and the Division of General Internal Medicine and Public Health (R.S.D.), Department of Medicine, the Departments of Biostatistics (O.M.O., R.R.) and Pharmaceutical Services (J.L.S.), and Division of Trauma and Surgical Critical Care, Department of Surgery (M.B.P.), Vanderbilt University Medical Center, and the Anesthesia Service (C.G.H., P.P.P.), Research Service (J.C.J.), Surgical Service (M.B.P.), and Geriatric Research, Education and Clinical Center (R.S.D., E.W.E.), Department of Veterans Affairs Medical Center, Tennessee Valley Healthcare System - both in Nashville; the Neuroscience Institute and Department of Critical Care Medicine, Maine Medical Center, Portland (P.T.M.); the Department of Pharmacy and Health Systems Sciences, Bouve College of Health Sciences, Northeastern University, Boston (J.W.D., M.S.D.); the Departments of Pharmacy (J.T.S., L.N.B.) and Surgery (J.T.S.) and the Center for Outcomes Research (J.T.S.), Houston Methodist, and the Pulmonary, Critical Care and Sleep Medicine Section, Ben Taub Hospital, Baylor College of Medicine (K.K.G.), Houston; the Division of Pulmonary/Critical Care Medicine, University of Texas Health, and the South Texas Veterans Health Care System, San Antonio (A.A.); and Texas Health Harris Methodist Hospital Fort Worth, Fort Worth (A.S.) - all in Texas; the University of Sydney, and the Department of Anaesthetics, Royal Prince Alfred Hospital, Sydney, and the Department of Anesthesiology, University of Wisconsin, Madison (R.D.S.); Pulmonary and Critical Care Medicine, Baton Rouge General Medical Center and Our Lady of the Lake Regional Medical Center, Baton Rouge, LA (H.R.O.); the Department of Anesthesia and Perioperative Care, University of California, San Francisco, San Francisco (M.A.G.); Pulmonary and Critical Care, Mission Hospital, Asheville, NC (G.J.S.); the Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus (N.E.B.); and Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh (T.D.G.).'}, {'ForeName': 'Gordon R', 'Initials': 'GR', 'LastName': 'Bernard', 'Affiliation': 'From the Critical Illness, Brain Dysfunction, and Survivorship Center (C.G.H., J.C.J., A.S.H., B.T.P., O.M.O., R.R., J.L.S., A.L.K, M.B.P., N.E.B., T.D.G., R.S.D., G.R.B., E.W.E., P.P.P.), the Center for Health Services Research (C.G.H., J.C.J., R.R., M.B.P., T.D.G., R.S.D., E.W.E., P.P.P.), the Division of Anesthesiology Critical Care Medicine, Department of Anesthesiology (C.G.H., P.P.P.), the Division of Allergy, Pulmonary, and Critical Care Medicine (J.C.J., B.T.P., G.R.B., E.W.E.), and the Division of General Internal Medicine and Public Health (R.S.D.), Department of Medicine, the Departments of Biostatistics (O.M.O., R.R.) and Pharmaceutical Services (J.L.S.), and Division of Trauma and Surgical Critical Care, Department of Surgery (M.B.P.), Vanderbilt University Medical Center, and the Anesthesia Service (C.G.H., P.P.P.), Research Service (J.C.J.), Surgical Service (M.B.P.), and Geriatric Research, Education and Clinical Center (R.S.D., E.W.E.), Department of Veterans Affairs Medical Center, Tennessee Valley Healthcare System - both in Nashville; the Neuroscience Institute and Department of Critical Care Medicine, Maine Medical Center, Portland (P.T.M.); the Department of Pharmacy and Health Systems Sciences, Bouve College of Health Sciences, Northeastern University, Boston (J.W.D., M.S.D.); the Departments of Pharmacy (J.T.S., L.N.B.) and Surgery (J.T.S.) and the Center for Outcomes Research (J.T.S.), Houston Methodist, and the Pulmonary, Critical Care and Sleep Medicine Section, Ben Taub Hospital, Baylor College of Medicine (K.K.G.), Houston; the Division of Pulmonary/Critical Care Medicine, University of Texas Health, and the South Texas Veterans Health Care System, San Antonio (A.A.); and Texas Health Harris Methodist Hospital Fort Worth, Fort Worth (A.S.) - all in Texas; the University of Sydney, and the Department of Anaesthetics, Royal Prince Alfred Hospital, Sydney, and the Department of Anesthesiology, University of Wisconsin, Madison (R.D.S.); Pulmonary and Critical Care Medicine, Baton Rouge General Medical Center and Our Lady of the Lake Regional Medical Center, Baton Rouge, LA (H.R.O.); the Department of Anesthesia and Perioperative Care, University of California, San Francisco, San Francisco (M.A.G.); Pulmonary and Critical Care, Mission Hospital, Asheville, NC (G.J.S.); the Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus (N.E.B.); and Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh (T.D.G.).'}, {'ForeName': 'E Wesley', 'Initials': 'EW', 'LastName': 'Ely', 'Affiliation': 'From the Critical Illness, Brain Dysfunction, and Survivorship Center (C.G.H., J.C.J., A.S.H., B.T.P., O.M.O., R.R., J.L.S., A.L.K, M.B.P., N.E.B., T.D.G., R.S.D., G.R.B., E.W.E., P.P.P.), the Center for Health Services Research (C.G.H., J.C.J., R.R., M.B.P., T.D.G., R.S.D., E.W.E., P.P.P.), the Division of Anesthesiology Critical Care Medicine, Department of Anesthesiology (C.G.H., P.P.P.), the Division of Allergy, Pulmonary, and Critical Care Medicine (J.C.J., B.T.P., G.R.B., E.W.E.), and the Division of General Internal Medicine and Public Health (R.S.D.), Department of Medicine, the Departments of Biostatistics (O.M.O., R.R.) and Pharmaceutical Services (J.L.S.), and Division of Trauma and Surgical Critical Care, Department of Surgery (M.B.P.), Vanderbilt University Medical Center, and the Anesthesia Service (C.G.H., P.P.P.), Research Service (J.C.J.), Surgical Service (M.B.P.), and Geriatric Research, Education and Clinical Center (R.S.D., E.W.E.), Department of Veterans Affairs Medical Center, Tennessee Valley Healthcare System - both in Nashville; the Neuroscience Institute and Department of Critical Care Medicine, Maine Medical Center, Portland (P.T.M.); the Department of Pharmacy and Health Systems Sciences, Bouve College of Health Sciences, Northeastern University, Boston (J.W.D., M.S.D.); the Departments of Pharmacy (J.T.S., L.N.B.) and Surgery (J.T.S.) and the Center for Outcomes Research (J.T.S.), Houston Methodist, and the Pulmonary, Critical Care and Sleep Medicine Section, Ben Taub Hospital, Baylor College of Medicine (K.K.G.), Houston; the Division of Pulmonary/Critical Care Medicine, University of Texas Health, and the South Texas Veterans Health Care System, San Antonio (A.A.); and Texas Health Harris Methodist Hospital Fort Worth, Fort Worth (A.S.) - all in Texas; the University of Sydney, and the Department of Anaesthetics, Royal Prince Alfred Hospital, Sydney, and the Department of Anesthesiology, University of Wisconsin, Madison (R.D.S.); Pulmonary and Critical Care Medicine, Baton Rouge General Medical Center and Our Lady of the Lake Regional Medical Center, Baton Rouge, LA (H.R.O.); the Department of Anesthesia and Perioperative Care, University of California, San Francisco, San Francisco (M.A.G.); Pulmonary and Critical Care, Mission Hospital, Asheville, NC (G.J.S.); the Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus (N.E.B.); and Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh (T.D.G.).'}, {'ForeName': 'Pratik P', 'Initials': 'PP', 'LastName': 'Pandharipande', 'Affiliation': 'From the Critical Illness, Brain Dysfunction, and Survivorship Center (C.G.H., J.C.J., A.S.H., B.T.P., O.M.O., R.R., J.L.S., A.L.K, M.B.P., N.E.B., T.D.G., R.S.D., G.R.B., E.W.E., P.P.P.), the Center for Health Services Research (C.G.H., J.C.J., R.R., M.B.P., T.D.G., R.S.D., E.W.E., P.P.P.), the Division of Anesthesiology Critical Care Medicine, Department of Anesthesiology (C.G.H., P.P.P.), the Division of Allergy, Pulmonary, and Critical Care Medicine (J.C.J., B.T.P., G.R.B., E.W.E.), and the Division of General Internal Medicine and Public Health (R.S.D.), Department of Medicine, the Departments of Biostatistics (O.M.O., R.R.) and Pharmaceutical Services (J.L.S.), and Division of Trauma and Surgical Critical Care, Department of Surgery (M.B.P.), Vanderbilt University Medical Center, and the Anesthesia Service (C.G.H., P.P.P.), Research Service (J.C.J.), Surgical Service (M.B.P.), and Geriatric Research, Education and Clinical Center (R.S.D., E.W.E.), Department of Veterans Affairs Medical Center, Tennessee Valley Healthcare System - both in Nashville; the Neuroscience Institute and Department of Critical Care Medicine, Maine Medical Center, Portland (P.T.M.); the Department of Pharmacy and Health Systems Sciences, Bouve College of Health Sciences, Northeastern University, Boston (J.W.D., M.S.D.); the Departments of Pharmacy (J.T.S., L.N.B.) and Surgery (J.T.S.) and the Center for Outcomes Research (J.T.S.), Houston Methodist, and the Pulmonary, Critical Care and Sleep Medicine Section, Ben Taub Hospital, Baylor College of Medicine (K.K.G.), Houston; the Division of Pulmonary/Critical Care Medicine, University of Texas Health, and the South Texas Veterans Health Care System, San Antonio (A.A.); and Texas Health Harris Methodist Hospital Fort Worth, Fort Worth (A.S.) - all in Texas; the University of Sydney, and the Department of Anaesthetics, Royal Prince Alfred Hospital, Sydney, and the Department of Anesthesiology, University of Wisconsin, Madison (R.D.S.); Pulmonary and Critical Care Medicine, Baton Rouge General Medical Center and Our Lady of the Lake Regional Medical Center, Baton Rouge, LA (H.R.O.); the Department of Anesthesia and Perioperative Care, University of California, San Francisco, San Francisco (M.A.G.); Pulmonary and Critical Care, Mission Hospital, Asheville, NC (G.J.S.); the Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus (N.E.B.); and Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh (T.D.G.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2024922'] 2121,33548056,Is social support pre-treatment associated with prognosis for adults with depression in primary care?,"OBJECTIVE Depressed patients rate social support as important for prognosis, but evidence for a prognostic effect is lacking. We aimed to test the association between social support and prognosis independent of treatment type, and the severity of depression, and other clinical features indicating a more severe illness. METHODS Individual patient data were collated from all six eligible RCTs (n = 2858) of adults seeking treatment for depression in primary care. Participants were randomized to any treatment and completed the same baseline assessment of social support and clinical severity factors. Two-stage random effects meta-analyses were conducted. RESULTS Social support was associated with prognosis independent of randomized treatment but effects were smaller when adjusting for depressive symptoms and durations of depression and anxiety, history of antidepressant treatment, and comorbid panic disorder: percentage decrease in depressive symptoms at 3-4 months per z-score increase in social support = -4.14(95%CI: -6.91 to -1.29). Those with a severe lack of social support had considerably worse prognoses than those with no lack of social support: increase in depressive symptoms at 3-4 months = 14.64%(4.25% to 26.06%). CONCLUSIONS Overall, large differences in social support pre-treatment were associated with differences in prognostic outcomes. Adding the Social Support scale to clinical assessments may be informative, but after adjusting for routinely assessed clinical prognostic factors the differences in prognosis are unlikely to be of a clinically important magnitude. Future studies might investigate more intensive treatments and more regular clinical reviews to mitigate risks of poor prognosis for those reporting a severe lack of social support.",2021,"RESULTS Social support was associated with prognosis independent of randomized treatment but effects were smaller when adjusting for depressive symptoms and durations of depression and anxiety, history of antidepressant treatment, and co-morbid panic disorder: percentage decrease in depressive symptoms at 3-4 months per z-score increase in social support =-4.14(95%CI:",['Individual patient data were collated from all six eligible RCTs (n=2858) of adults seeking treatment for depression in primary care'],[],"['depressive symptoms', 'depressive symptoms and durations of depression and anxiety, history of antidepressant treatment, and co-morbid panic disorder', 'social support =-4.14(95%CI']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]",[],"[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0037438', 'cui_str': 'Social support'}]",,0.0314645,"RESULTS Social support was associated with prognosis independent of randomized treatment but effects were smaller when adjusting for depressive symptoms and durations of depression and anxiety, history of antidepressant treatment, and co-morbid panic disorder: percentage decrease in depressive symptoms at 3-4 months per z-score increase in social support =-4.14(95%CI:","[{'ForeName': 'Joshua E J', 'Initials': 'JEJ', 'LastName': 'Buckman', 'Affiliation': 'Centre for Outcomes Research and Effectiveness (CORE), Research Department of Clinical, Educational & Health Psychology, University College London, London, UK.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Saunders', 'Affiliation': 'Centre for Outcomes Research and Effectiveness (CORE), Research Department of Clinical, Educational & Health Psychology, University College London, London, UK.'}, {'ForeName': 'Ciaran', 'Initials': 'C', 'LastName': ""O'Driscoll"", 'Affiliation': 'Centre for Outcomes Research and Effectiveness (CORE), Research Department of Clinical, Educational & Health Psychology, University College London, London, UK.'}, {'ForeName': 'Zachary D', 'Initials': 'ZD', 'LastName': 'Cohen', 'Affiliation': 'Department of Psychiatry, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Stott', 'Affiliation': 'Centre for Outcomes Research and Effectiveness (CORE), Research Department of Clinical, Educational & Health Psychology, University College London, London, UK.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Ambler', 'Affiliation': 'Statistical Science, University College London, London, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gilbody', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Hollon', 'Affiliation': 'Department of Psychology, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Kendrick', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Watkins', 'Affiliation': 'Department of Psychology, University of Exeter, Exeter, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Wiles', 'Affiliation': 'Centre for Academic Mental Health, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kessler', 'Affiliation': 'Centre for Academic Primary Care, Department of Population Health Science, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Nomsa', 'Initials': 'N', 'LastName': 'Chari', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'White', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Lewis', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Pilling', 'Affiliation': 'Centre for Outcomes Research and Effectiveness (CORE), Research Department of Clinical, Educational & Health Psychology, University College London, London, UK.'}]",Acta psychiatrica Scandinavica,['10.1111/acps.13285'] 2122,33548020,Safety of As-Needed Budesonide-Formoterol in Mild Asthma: Data from the Two Phase III SYGMA Studies.,"INTRODUCTION Budesonide-formoterol taken as needed is an emerging treatment for mild asthma. OBJECTIVE We used data from the SYGMA studies to assess the safety of As-needed budesonide-formoterol compared with As-needed terbutaline and compared with maintenance budesonide. METHODS SYGMA 1 and 2 were 52-week, double-blind, parallel-group studies in patients aged ≥ 12 years with physician-assessed mild asthma. Patients were randomized to As-needed budesonide-formoterol 200/6 μg, twice-daily budesonide 200 μg as maintenance plus As-needed terbutaline 0.5 mg, and As-needed terbutaline 0.5 mg (SYGMA 1 only). Adverse events (AEs), serious AEs (SAEs), discontinuations due to AEs (DAEs), and study-defined asthma-related discontinuations from corresponding treatment groups in both studies were pooled. SYGMA 1 data were used for comparisons with As-needed terbutaline alone. RESULTS The pooled analysis included 3366 patients in the As-needed budesonide-formoterol group and 3369 in the budesonide maintenance group, with AEs in 40.8% and 42.5% of patients, respectively. Common AEs included viral upper respiratory tract infection (viral URTI) and URTI. SAE, DAE, and asthma-related discontinuation rates were similar with As-needed budesonide-formoterol and maintenance budesonide. Potential local and systemic corticosteroid class effects were reported in ≤ 1% of patients for each budesonide-containing regimen. In SYGMA 1, AEs were more common in the As-needed terbutaline (n = 1277) than As-needed budesonide-formoterol (n = 1277) groups (42.7 vs. 38.0%), as were DAEs (2.9 vs. 0.8%) and asthma-related discontinuations (1.6 vs. 0.3%). CONCLUSIONS Budesonide-formoterol anti-inflammatory reliever therapy is generally well-tolerated in patients with mild asthma and has a safety profile similar to that of daily budesonide. No new safety signals were identified. CLINICALTRIAL. GOV IDENTIFIERS NCT02149199 (SYGMA 1) and NCT02224157 (SYGMA 2).",2021,"In SYGMA 1, AEs were more common in the As-needed terbutaline (n = 1277) than As-needed budesonide-formoterol (n = 1277) groups (42.7 vs. 38.0%), as were DAEs (2.9 vs. 0.8%) and asthma-related discontinuations (1.6 vs. 0.3%). ","['Mild Asthma', 'patients with mild asthma', 'SYGMA 1 and 2 were 52-week, double-blind, parallel-group studies in patients aged ≥ 12\xa0years with physician-assessed mild asthma', 'mild asthma', '3366 patients in the As-needed budesonide-formoterol group and 3369 in the budesonide maintenance group, with AEs in 40.8% and 42.5% of patients, respectively']","['budesonide-formoterol', 'budesonide-formoterol 200/6 μg, twice-daily budesonide 200\xa0μg as maintenance plus As-needed terbutaline 0.5\xa0mg, and As-needed terbutaline 0.5\xa0mg (SYGMA 1 only', 'Budesonide-Formoterol', 'Budesonide-formoterol']","['Adverse events (AEs), serious AEs (SAEs), discontinuations due to AEs (DAEs), and study-defined asthma-related discontinuations', 'Potential local and systemic corticosteroid class effects', 'viral upper respiratory tract infection (viral URTI) and URTI', 'SAE, DAE, and asthma-related discontinuation rates']","[{'cui': 'C0581124', 'cui_str': 'Mild asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]","[{'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0039542', 'cui_str': 'Terbutaline'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0339916', 'cui_str': 'Viral upper respiratory tract infection'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}]",,0.202048,"In SYGMA 1, AEs were more common in the As-needed terbutaline (n = 1277) than As-needed budesonide-formoterol (n = 1277) groups (42.7 vs. 38.0%), as were DAEs (2.9 vs. 0.8%) and asthma-related discontinuations (1.6 vs. 0.3%). ","[{'ForeName': 'J Mark', 'Initials': 'JM', 'LastName': 'FitzGerald', 'Affiliation': 'Centre for Lung Health, Vancouver Coastal Health Research Institute, University of British Columbia, 2775 Laurel Street, Vancouver, BC, V5Z1M9, Canada. Mark.fitzgerald@vch.ca.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': ""O'Byrne"", 'Affiliation': ""Firestone Institute for Respiratory Health, St Joseph's Healthcare and Department of Medicine, Michael G. DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada.""}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Bateman', 'Affiliation': 'Division of Pulmonology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Barnes', 'Affiliation': 'Airway Disease Section, National Heart and Lung Institute, Imperial College, London, UK.'}, {'ForeName': 'Jinping', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'State Key Laboratory of Respiratory Diseases, National Clinical Research Centre for Respiratory Disease, First Affiliated Hospital, Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Ivanov', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Lamarca', 'Affiliation': 'AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Larsdotter', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Emerath', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Gerreke', 'Initials': 'G', 'LastName': 'Jansen', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Margareta', 'Initials': 'M', 'LastName': 'Puu', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Vijay K T', 'Initials': 'VKT', 'LastName': 'Alagappan', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Surmont', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Helen K', 'Initials': 'HK', 'LastName': 'Reddel', 'Affiliation': 'Woolcock Institute of Medical Research, University of Sydney, Sydney, NSW, Australia.'}]",Drug safety,['10.1007/s40264-020-01041-z'] 2123,33549516,Transcranial Direct Current Stimulation to the Left Dorsolateral Prefrontal Cortex Improves Cognitive Control in Patients With Attention-Deficit/Hyperactivity Disorder: A Randomized Behavioral and Neurophysiological Study.,"BACKGROUND Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder associated with significant morbidity and mortality that may affect over 5% of children and approximately 2.8% of adults worldwide. Pharmacological and behavioral therapies for ADHD exist, but critical symptoms such as dysexecutive deficits remain unaffected. In a randomized, sham-controlled, double-blind, crossover mechanistic study, we assessed the cognitive and physiological effects of transcranial direct current stimulation (tDCS) in 40 adult patients with ADHD in order to identify diagnostic (cross-sectional) and treatment biomarkers (targets). METHODS Patients performed three experimental sessions in which they received 30 minutes of 2 mA anodal tDCS targeting the left dorsolateral prefrontal cortex, 30 minutes of 2 mA anodal tDCS targeting the right dorsolateral prefrontal cortex, and 30 minutes of sham. Before and after each session, half the patients completed the Eriksen flanker task and the other half completed the stop signal task while we assessed behavior (reaction time, accuracy) and neurophysiology (event-related potentials). RESULTS Anodal tDCS to the left dorsolateral prefrontal cortex modulated cognitive (reaction time) and physiological (P300 amplitude) measures in the Eriksen flanker task in a state-dependent manner, but no effects were found in the stop signal reaction time of the stop signal task. CONCLUSIONS These findings show procognitive effects in ADHD associated with the modulation of event-related potential signatures of cognitive control, linking target engagement with cognitive benefit, proving the value of event-related potentials as cross-sectional biomarkers of executive performance, and mechanistically supporting the state-dependent nature of tDCS. We interpret these results as an improvement in cognitive control but not action cancellation, supporting the existence of different impulsivity constructs with overlapping but distinct anatomical substrates, and highlighting the implications for the development of individualized therapeutics.",2021,"RESULTS Anodal tDCS to the left dorsolateral prefrontal cortex modulated cognitive (reaction time) and physiological (P300 amplitude) measures in the Eriksen flanker task in a state-dependent manner, but no effects were found in the stop signal reaction time of the stop signal task. ","['With Attention-Deficit/Hyperactivity Disorder', 'Patients', '40 adult patients with ADHD in order to identify diagnostic (cross-sectional) and treatment biomarkers (targets']","['mA anodal tDCS targeting the left dorsolateral prefrontal cortex, 30 minutes of 2 mA anodal tDCS targeting the right dorsolateral prefrontal cortex, and 30 minutes of sham', 'transcranial direct current stimulation (tDCS', 'Transcranial Direct Current Stimulation']","['behavior (reaction time, accuracy) and neurophysiology (event-related potentials', 'left dorsolateral prefrontal cortex modulated cognitive (reaction time) and physiological (P300 amplitude) measures']","[{'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0027901', 'cui_str': 'Neurophysiology'}, {'cui': 'C0282171', 'cui_str': 'Event-related potentials'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0444781', 'cui_str': 'P300 (P3)'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",40.0,0.0436272,"RESULTS Anodal tDCS to the left dorsolateral prefrontal cortex modulated cognitive (reaction time) and physiological (P300 amplitude) measures in the Eriksen flanker task in a state-dependent manner, but no effects were found in the stop signal reaction time of the stop signal task. ","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dubreuil-Vall', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts; Department of Psychiatry and Clinical Psychobiology, Universitat de Barcelona, Barcelona, Spain; Neuroelectrics Corporation, Barcelona, Spain. Electronic address: ldubreuilvall@mgh.harvard.edu.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Gomez-Bernal', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Ana C', 'Initials': 'AC', 'LastName': 'Villegas', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Cirillo', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Surman', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Ruffini', 'Affiliation': 'Neuroelectrics Corporation, Barcelona, Spain.'}, {'ForeName': 'Alik S', 'Initials': 'AS', 'LastName': 'Widge', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Joan A', 'Initials': 'JA', 'LastName': 'Camprodon', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}]",Biological psychiatry. Cognitive neuroscience and neuroimaging,['10.1016/j.bpsc.2020.11.006'] 2124,33549004,The impact of palliative care education and training program on the resident physicians.,"BACKGROUND Due to the advancements in medicine coupled with the aging population, palliative care has become widely needed. In many countries, medical students are trained in palliative care in their postgraduate courses. However, palliative care education is not available as an independent course or standardized training for residents in China. METHODS This parallel randomized controlled trial was conducted in the Department of Internal Medicine, Beijing Chao-yang Hospital, Capital Medical University, between June 2016 and August 2017. The aim of the study was to explore the impact of the palliative care education and training program on 72 residents who were trained in standardization and were randomly divided into experimental and control groups at the ratio 1:1. The experimental group received resident physician standardized training and palliative care training program, while the control group received only standardized training. Standardized training included training in humanistic medical skills. The two groups were tested after training. A questionnaire survey was carried out to analyze the effect of palliative care education in humanistic medical skills. RESULTS The total score of humanistic medical skills assessment of residents in the experimental group was higher compared to the control group (82.92±8.39 vs. 77.36±7.41, t =2.978, P=0.004). The experimental group performed better in terms of medical skills and the ability to care for dying patients. CONCLUSIONS Palliative care education and training program should be required for residents as it is very useful. The purpose of palliative care education is to translate the knowledge in practice, truly implement the idea of palliative care, and relieve patients of terminal discomfort. The educational promotion of palliative care is of great value in China.",2021,"The total score of humanistic medical skills assessment of residents in the experimental group was higher compared to the control group (82.92±8.39 vs. 77.36±7.41, t =2.978, P=0.004).","['Department of Internal Medicine, Beijing Chao-yang Hospital, Capital Medical University, between June 2016 and August 2017', 'residents in China', '72 residents who were trained in standardization']","['resident physician standardized training and palliative care training program, while the control group received only standardized training', 'palliative care education', 'palliative care education and training program']",['total score of humanistic medical skills assessment of residents'],"[{'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C1194380', 'cui_str': 'Chaos'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0038136', 'cui_str': 'Standardization'}]","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3266593', 'cui_str': 'Palliative care education'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]",,0.0184707,"The total score of humanistic medical skills assessment of residents in the experimental group was higher compared to the control group (82.92±8.39 vs. 77.36±7.41, t =2.978, P=0.004).","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chang', 'Affiliation': 'Department of Internal Medicine, Beijing Chao-yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhuoran', 'Initials': 'Z', 'LastName': 'Qi', 'Affiliation': 'Department of Internal Medicine, Beijing Chao-yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': 'Department of Internal Medicine, Beijing Chao-yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Medical Education, Beijing Chao-yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Qianmei', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': 'Department of Internal Medicine, Beijing Chao-yang Hospital, Capital Medical University, Beijing, China. sunqianmei5825@126.com.'}]",Annals of palliative medicine,['10.21037/apm-20-1625'] 2125,33547300,Efficacy and tolerability of bevacizumab in patients with severe Covid-19.,"On the basis of Covid-19-induced pulmonary pathological and vascular changes, we hypothesize that the anti-vascular endothelial growth factor (VEGF) drug bevacizumab might be beneficial for treating Covid-19 patients. From Feb 15 to April 5, 2020, we conducted a single-arm trial (NCT04275414) and recruited 26 patients from 2-centers (China and Italy) with severe Covid-19, with respiratory rate ≥30 times/min, oxygen saturation ≤93% with ambient air, or partial arterial oxygen pressure to fraction of inspiration O 2 ratio (PaO 2 /FiO 2 ) >100 mmHg and ≤300 mmHg, and diffuse pneumonia confirmed by chest imaging. Followed up for 28 days. Among these, bevacizumab plus standard care markedly improves the PaO 2 /FiO 2 ratios at days 1 and 7. By day 28, 24 (92%) patients show improvement in oxygen-support status, 17 (65%) patients are discharged, and none show worsen oxygen-support status nor die. Significant reduction of lesion areas/ratios are shown in chest computed tomography (CT) or X-ray within 7 days. Of 14 patients with fever, body temperature normalizes within 72 h in 13 (93%) patients. Relative to comparable controls, bevacizumab shows clinical efficacy by improving oxygenation and shortening oxygen-support duration. Our findings suggest bevacizumab plus standard care is highly beneficial for patients with severe Covid-19. Randomized controlled trial is warranted.",2021,Significant reduction of lesion areas/ratios are shown in chest computed tomography (CT) or X-ray within 7 days.,"['patients with severe Covid-19', '14 patients with fever, body temperature normalizes within 72\u2009h in 13 (93%) patients', '26 patients from 2-centers', 'China and Italy) with severe Covid-19, with respiratory rate ≥30']",['bevacizumab'],"['times/min, oxygen saturation ≤93% with ambient air, or partial arterial oxygen pressure to fraction of inspiration O 2 ratio (PaO 2 /FiO 2 ', 'oxygen-support status', 'Efficacy and tolerability', 'worsen oxygen-support status nor die']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",14.0,0.136155,Significant reduction of lesion areas/ratios are shown in chest computed tomography (CT) or X-ray within 7 days.,"[{'ForeName': 'Jiaojiao', 'Initials': 'J', 'LastName': 'Pang', 'Affiliation': 'Department of Emergency Medicine, Shandong Provincial Clinical Research Center for Emergency and Critical Care Medicine, Institute of Emergency and Critical Care Medicine of Shandong University, Qilu Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Department of Emergency Medicine, Shandong Provincial Clinical Research Center for Emergency and Critical Care Medicine, Institute of Emergency and Critical Care Medicine of Shandong University, Qilu Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Gianmarco', 'Initials': 'G', 'LastName': 'Aondio', 'Affiliation': 'Department of Medicine and Oncology, Moriggia-Pelascini Hospital, Gravedona ed Uniti, Gravedona, Italy.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Qilu Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Fumagalli', 'Affiliation': 'Department of Medicine and Oncology, Moriggia-Pelascini Hospital, Gravedona ed Uniti, Gravedona, Italy.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Lu', 'Affiliation': 'Clinical Research Center of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Valmadre', 'Affiliation': 'Department of Medicine and Oncology, Moriggia-Pelascini Hospital, Gravedona ed Uniti, Gravedona, Italy.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'Department of Emergency Medicine, Renmin Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Bian', 'Affiliation': 'Department of Emergency Medicine, Shandong Provincial Clinical Research Center for Emergency and Critical Care Medicine, Institute of Emergency and Critical Care Medicine of Shandong University, Qilu Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Canesi', 'Affiliation': 'Department of Neurological Rehabilitation, Moriggia-Pelascini Hospital, Gravedona ed Uniti, Gravedona, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Damiani', 'Affiliation': 'Department of Radiology, Moriggia-Pelascini Hospital, Gravedona ed Uniti, Gravedona, Italy.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Clinical Research Center of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Dexin', 'Initials': 'D', 'LastName': 'Yu', 'Affiliation': 'Department of Radiology, Qilu Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, Renmin Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Ji', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Qilu Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Wenhai', 'Initials': 'W', 'LastName': 'Sui', 'Affiliation': 'Key Laboratory of Cardiovascular Remodeling and Function Research, Chinese Ministry of Education, Chinese National Health Commission and Chinese Academy of Medical Sciences, The State and Shandong Province Joint Key Laboratory of Translational Cardiovascular Medicine, Jinan, Shandong, China.'}, {'ForeName': 'Bailu', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Clinical Research Center of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Emergency Medicine, Shandong Provincial Clinical Research Center for Emergency and Critical Care Medicine, Institute of Emergency and Critical Care Medicine of Shandong University, Qilu Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Attila', 'Initials': 'A', 'LastName': 'Kovacs', 'Affiliation': 'Department of Intensive Care Unit, Moriggia-Pelascini Hospital, Gravedona ed Uniti, Gravedona, 22015, Italy.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Revera', 'Affiliation': 'Department of Cardiology, Moriggia-Pelascini Hospital, Gravedona ed Uniti, Gravedona, 22015, Italy.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Critical Care Medicine, Qilu Hospital of Shandong University, Jinan, Shandong, 250012, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Jing', 'Affiliation': 'Department of Emergency Medicine, Shandong Provincial Clinical Research Center for Emergency and Critical Care Medicine, Institute of Emergency and Critical Care Medicine of Shandong University, Qilu Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Emergency Medicine, Shandong Provincial Clinical Research Center for Emergency and Critical Care Medicine, Institute of Emergency and Critical Care Medicine of Shandong University, Qilu Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Yuguo', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Emergency Medicine, Shandong Provincial Clinical Research Center for Emergency and Critical Care Medicine, Institute of Emergency and Critical Care Medicine of Shandong University, Qilu Hospital of Shandong University, Jinan, Shandong, China. chen919085@sdu.edu.cn.'}, {'ForeName': 'Yihai', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Department of Microbiology, Tumor and Cell Biology, Karolinska Institutet, Stockholm, 17177, Sweden. yihai.cao@ki.se.'}]",Nature communications,['10.1038/s41467-021-21085-8'] 2126,33551284,"Effects of Repetitive Transcranial Magnetic Stimulation on Working Memory Performance and Brain Structure in People With Schizophrenia Spectrum Disorders: A Double-Blind, Randomized, Sham-Controlled Trial.","BACKGROUND There are currently no approved treatments for working memory deficits in schizophrenia spectrum disorders (SSDs). The objective of the present study was to assess whether repetitive transcranial magnetic stimulation (rTMS) to the bilateral dorsolateral prefrontal cortex (DLPFC) in people with SSDs 1) improves working memory deficits and 2) changes brain structure. METHODS We conducted a double-blind, parallel, randomized, sham-controlled study at the Centre for Addiction and Mental Health in Toronto, Canada. We randomized 83 participants with SSDs to receive either active 20 Hz rTMS applied to the bilateral DLPFC or sham rTMS for 4 weeks. The participants also completed pre/posttreatment magnetic resonance imaging. Clinical and cognitive assessments were performed at baseline, treatment end, and 1 month later. The primary outcome was change in verbal n-back working memory performance accuracy (d-prime). The secondary outcome measures were change in DLPFC thickness and fractional anisotropy of white matter tracts connecting to the DLPFC. Prespecified exploratory outcome measures were changes in general cognition; positive, negative, and depressive symptoms. RESULTS Compared with sham treatment, active rTMS did not lead to significant change in working memory performance; it was associated with an increase in right DLPFC thickness but not fractional anisotropy. Prespecified exploratory analysis showed a significant decrease in depressive symptoms in the active group; the decrease in depressive symptoms was correlated with an increase in right DLPFC thickness. CONCLUSIONS Although rTMS applied to the bilateral DLPFC was not efficacious in treating working memory deficits in SSDs, it did increase right DLPFC thickness and decrease depressive symptoms. These findings deserve further study given the lack of efficacy of antidepressant medications in SSDs.",2021,"Compared with sham treatment, active rTMS did not lead to significant change in working memory performance; it was associated with an increase in right DLPFC thickness but not fractional anisotropy.","['people with SSDs 1', 'People With Schizophrenia Spectrum Disorders', 'Centre for Addiction and Mental Health in Toronto, Canada', '83 participants with SSDs to receive either', 'schizophrenia spectrum disorders (SSDs']","['active 20 Hz rTMS applied to the bilateral DLPFC or sham rTMS', 'rTMS', 'repetitive transcranial magnetic stimulation (rTMS', 'Repetitive Transcranial Magnetic Stimulation']","['change in DLPFC thickness and fractional anisotropy of white matter tracts connecting to the DLPFC', 'changes in general cognition; positive, negative, and depressive symptoms', 'depressive symptoms', 'change in verbal n-back working memory performance accuracy (d-prime', 'working memory performance', 'right DLPFC thickness', 'Working Memory Performance and Brain Structure']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0723179', 'cui_str': 'SSD'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0071973', 'cui_str': 'PRIME protocol'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}]",83.0,0.55993,"Compared with sham treatment, active rTMS did not lead to significant change in working memory performance; it was associated with an increase in right DLPFC thickness but not fractional anisotropy.","[{'ForeName': 'Aristotle N', 'Initials': 'AN', 'LastName': 'Voineskos', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada. Electronic address: Aristotle.Voineskos@camh.ca.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Christin', 'Initials': 'C', 'LastName': 'Schifani', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Hawco', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Erin W', 'Initials': 'EW', 'LastName': 'Dickie', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Tarek K', 'Initials': 'TK', 'LastName': 'Rajji', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Foussias', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada; Department of Psychiatry, University of California San Diego School of Medicine, La Jolla, California.'}]",Biological psychiatry. Cognitive neuroscience and neuroimaging,['10.1016/j.bpsc.2020.11.011'] 2127,33550634,Comparison between the use of intense pulsed light and Q-switched neodymium-doped yttrium aluminum garnet laser for the treatment of axillary hyperpigmentation.,"BACKGROUND Axillary hyperpigmentation (AH) is a condition in which axillary skin is darker than the adjacent areas. To date, there is no standard treatment for AH. The Q-switched neodymium-doped yttrium aluminum garnet 1064-nm(QS) laser and intense pulsed light (IPL) are two effective modalities for the treatment of pigmentary disorders; however, the efficacy and safety levels of both treatments for AH have not yet been compared in a controlled study. AIMS To evaluate and compare the efficacy and safety of the QS laser and IPL in the treatment of AH. METHODS A randomized, split-side study was conducted on 22 subjects; all subjects received a total of five split-side treatments every 2 weeks. The efficacy was determined using the melanin index (MI), color chart level using the Pantone SkinTone™ Guide, improvement grading scale (IGS), and patient satisfaction scores at weeks 2, 4, 6, 8, and 10. RESULTS The results showed that there was no significant difference in MI, color chart level, IGS, and patient satisfaction scores between the two treatments. Both treatments significantly improved AH after three sessions. However, the pain score was lower for IPL treatment. The adverse effects were transient and were found after IPL treatment in one participant (4.45%) who developed hyperpigmentation and another participant (4.45%) who developed erythema. CONCLUSIONS Intense pulsed light therapy is safe and effective for the treatment of AH, with no significant difference in the outcome compared with QS laser treatment.",2021,"The results showed that there was no significant difference in MI, color chart level, IGS, and patient satisfaction scores between the two treatments.","['axillary hyperpigmentation', '22 subjects; all subjects']","['QS laser and IPL', 'intense pulsed light and Q-switched neodymium-doped yttrium aluminum garnet laser', 'neodymium-doped yttrium aluminum garnet 1064-nm(QS', 'laser and intense pulsed light (IPL', 'IPL therapy']","['efficacy and safety levels', 'pain score', 'melanin index (MI), color chart level using the Pantone Skintone™ Guide, improvement grading scale (IGS), and patient satisfaction scores', 'MI, color chart level, IGS, and patient satisfaction scores', 'efficacy and safety', 'adverse effects']","[{'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}]","[{'cui': 'C1289832', 'cui_str': 'Q-switching laser device'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0392276', 'cui_str': 'Neodymium-YAG laser'}, {'cui': 'C0027599', 'cui_str': 'Neodymium'}, {'cui': 'C0013039', 'cui_str': 'Doping in Sports'}, {'cui': 'C1609285', 'cui_str': 'yttrium-aluminum-garnet'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0025196', 'cui_str': 'Melanin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",22.0,0.0205367,"The results showed that there was no significant difference in MI, color chart level, IGS, and patient satisfaction scores between the two treatments.","[{'ForeName': 'Watinee', 'Initials': 'W', 'LastName': 'Amornpetkul', 'Affiliation': 'Skin Center, Faculty of Medicine, Srinakharinwirot University, Bangkok, Thailand.'}, {'ForeName': 'Silada', 'Initials': 'S', 'LastName': 'Kanokrungsee', 'Affiliation': 'Skin Center, Faculty of Medicine, Srinakharinwirot University, Bangkok, Thailand.'}, {'ForeName': 'Nanticha', 'Initials': 'N', 'LastName': 'Kamanamool', 'Affiliation': 'Department of Preventive and Social Medicine, Srinakharinwirot University, Bangkok, Thailand.'}, {'ForeName': 'Montree', 'Initials': 'M', 'LastName': 'Udompataikul', 'Affiliation': 'Skin Center, Faculty of Medicine, Srinakharinwirot University, Bangkok, Thailand.'}, {'ForeName': 'Salinee', 'Initials': 'S', 'LastName': 'Rojhirunsakool', 'Affiliation': 'Skin Center, Faculty of Medicine, Srinakharinwirot University, Bangkok, Thailand.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13981'] 2128,33559842,Safety and Efficacy of Prefilled Liquid Etanercept-Biosimilar Yisaipu for Active Ankylosing Spondylitis: A Multi-Center Phase III Trial.,"INTRODUCTION The aim of this work is to examine the efficacy and safety of prefilled liquid etanercept-biosimilar Yisaipu versus lyophilized Yisaipu in active ankylosing spondylitis (AS) patients. METHODS This double-blind, phase III trial with non-inferiority design randomized adult patients with active AS in a 3:1:1 ratio to receive twice-weekly 25-mg prefilled liquid Yisaipu for a total of 48 injections (group I, n = 330), once-weekly 50-mg prefilled liquid Yisaipu for 24 injections (group II, n = 110), or twice-weekly 25-mg lyophilized Yisaipu for 48 injections (group III, n = 110). Both physicians and patients who received 25-mg twice-weekly lyophilized or liquid Yisaipu were blinded to treatment assignment while patients who received 50-mg once-weekly liquid Yisaipu received treatment in an open-label design. In addition, 90 patients in the PK/PD study were randomized in a 1:1:1 ratio to each group. The primary outcome was the proportion of patients who achieved ASAS20 at week 24. RESULTS A total of 640 subjects were enrolled. The proportion of patients who attained ASAS20 at week 24 was 85.56% in group I, 85.71% in group II, and 83.45% in group III (group I vs. III, P = 0.545; group II vs. III, P = 0.605). The difference between group I and III was 2.10% (95% CI - 5.06%, 9.27%) and 2.26% (95% CI - 6.21%, 10.73%) between group II and III, meeting the non-inferiority threshold (Δ = - 15%) (P < 0.001). Except for a statistical difference between group I (75.83%) and group III at week 8 (64.75%, P = 0.011), there was no statistical difference in the ASAS20 attainment rate among the three groups at other time points. The incidence of serious adverse events was comparable among the three groups (group I, 2.50%, II, 2.86% and III, 1.43%; P > 0.05). No deaths were reported. CONCLUSIONS Once-weekly 50-mg or twice-weekly 25-mg prefilled liquid Yisaipu is safe and non-inferior to twice-weekly 25-mg lyophilized Yisaipu. TRIAL REGISTRATION CTR20130124 and NCT04345458.",2021,"The incidence of serious adverse events was comparable among the three groups (group I, 2.50%, II, 2.86% and III, 1.43%; P > 0.05).","['adult patients with active AS in a 3:1:1 ratio to receive', 'active ankylosing spondylitis (AS) patients', 'Active Ankylosing Spondylitis', '640 subjects were enrolled', '90 patients in the PK/PD study']","['25-mg twice-weekly lyophilized or liquid', 'prefilled liquid etanercept-biosimilar Yisaipu versus lyophilized Yisaipu', 'Prefilled Liquid Etanercept-Biosimilar Yisaipu', 'twice-weekly 25-mg prefilled liquid Yisaipu']","['proportion of patients who achieved ASAS20', 'incidence of serious adverse events', 'efficacy and safety', 'Safety and Efficacy', 'ASAS20 attainment rate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4708790', 'cui_str': '640'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}]",640.0,0.0586866,"The incidence of serious adverse events was comparable among the three groups (group I, 2.50%, II, 2.86% and III, 1.43%; P > 0.05).","[{'ForeName': 'Dongbao', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'Department of Rheumatology and Immunology, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Dongyi', 'Initials': 'D', 'LastName': 'He', 'Affiliation': 'Department of Rheumatology, Guanghua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Liqi', 'Initials': 'L', 'LastName': 'Bi', 'Affiliation': 'Department of Rheumatology and Immunology, China-Japan Union Hospital of Jilin University, Changchun, Jilin Province, China.'}, {'ForeName': 'Huaxiang', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Rheumatology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Rheumatology, West China Hospital, Sichuan University, Chengdu, Sichuan Province, China.'}, {'ForeName': 'Zhenbiao', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': ""Department of Rheumatology, The First Affiliated Hospital of Air Force Medical University of PLA, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Rheumatology and Immunology, The Second Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang Province, China.'}, {'ForeName': 'Guochun', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Rheumatology, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Xingfu', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Rheumatology, Qilu Hospital of Shandong University, Jinan, Shandong Province, China.'}, {'ForeName': 'Chunde', 'Initials': 'C', 'LastName': 'Bao', 'Affiliation': 'Department of Rheumatology and Immunology, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Lindi', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Rheumatology and Immunology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Zhiyi', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Rheumatology, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang Province, China.'}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Xiao', 'Affiliation': 'Department of Rheumatology, The First Hospital of China Medical University, Shenyang , Liaoning Province, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Tong', 'Affiliation': 'Medical Department, R&D, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, Shanghai, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Medical Department, R&D, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, Shanghai, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Huang', 'Affiliation': 'Department of Rheumatology and Immunology, Chinese PLA General Hospital, Beijing, China. fhuang@301hospital.com.cn.'}]",Rheumatology and therapy,['10.1007/s40744-021-00276-1'] 2129,33564854,"High susceptibility to zoliflodacin and conserved target (GyrB) for zoliflodacin among 1209 consecutive clinical Neisseria gonorrhoeae isolates from 25 European countries, 2018.","OBJECTIVES Novel antimicrobials for treatment of gonorrhoea are imperative. The first-in-class spiropyrimidinetrione zoliflodacin is promising and currently in an international Phase 3 randomized controlled clinical trial (RCT) for treatment of uncomplicated gonorrhoea. We evaluated the in vitro activity of and the genetic conservation of the target (GyrB) and other potential zoliflodacin resistance determinants among 1209 consecutive clinical Neisseria gonorrhoeae isolates obtained from 25 EU/European Economic Area (EEA) countries in 2018 and compared the activity of zoliflodacin with that of therapeutic antimicrobials currently used. METHODS MICs of zoliflodacin, ceftriaxone, cefixime, azithromycin and ciprofloxacin were determined using an agar dilution technique for zoliflodacin or using MIC gradient strip tests or an agar dilution technique for the other antimicrobials. Genome sequences were available for 96.1% of isolates. RESULTS Zoliflodacin modal MIC, MIC50, MIC90 and MIC range were 0.125, 0.125, 0.125 and ≤0.004-0.5 mg/L, respectively. The resistance was 49.9%, 6.7%, 1.6% and 0.2% to ciprofloxacin, azithromycin, cefixime and ceftriaxone, respectively. Zoliflodacin did not show any cross-resistance to other tested antimicrobials. GyrB was highly conserved and no zoliflodacin gyrB resistance mutations were found. No fluoroquinolone target GyrA or ParC resistance mutations or mutations causing overexpression of the MtrCDE efflux pump substantially affected the MICs of zoliflodacin. CONCLUSIONS The in vitro susceptibility to zoliflodacin was high and the zoliflodacin target GyrB was conserved among EU/EEA gonococcal isolates in 2018. This study supports further clinical development of zoliflodacin. However, additional zoliflodacin data regarding particularly the treatment of pharyngeal gonorrhoea, pharmacokinetics/pharmacodynamics and resistance selection, including suppression, would be valuable.",2021,"RESULTS Zoliflodacin modal MIC, MIC50, MIC90 and MIC","['1209 consecutive clinical Neisseria gonorrhoeae isolates obtained from 25 EU/European Economic Area (EEA) countries in 2018 and compared the activity of zoliflodacin with that of therapeutic antimicrobials currently used', '1209 consecutive clinical Neisseria gonorrhoeae isolates from 25 European countries, 2018']","['zoliflodacin', 'ciprofloxacin, azithromycin, cefixime and ceftriaxone', 'Zoliflodacin', 'zoliflodacin, ceftriaxone, cefixime, azithromycin and ciprofloxacin', 'zoliflodacin and conserved target (GyrB) for zoliflodacin']","['Zoliflodacin modal MIC, MIC50, MIC90 and MIC']","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0027573', 'cui_str': 'Neisseria gonorrhoeae'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0454713', 'cui_str': 'European country'}]","[{'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0060400', 'cui_str': 'Cefixime'}, {'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}]","[{'cui': 'C0066256', 'cui_str': 'Methyl isocyanate'}]",,0.0494711,"RESULTS Zoliflodacin modal MIC, MIC50, MIC90 and MIC","[{'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Unemo', 'Affiliation': 'WHO Collaborating Centre for Gonorrhoea and Other STIs, National Reference Laboratory for STIs, Department of Laboratory Medicine, Microbiology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Josefine', 'Initials': 'J', 'LastName': 'Ahlstrand', 'Affiliation': 'WHO Collaborating Centre for Gonorrhoea and Other STIs, National Reference Laboratory for STIs, Department of Laboratory Medicine, Microbiology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Leonor', 'Initials': 'L', 'LastName': 'Sánchez-Busó', 'Affiliation': 'Centre for Genomic Pathogen Surveillance, Big Data Institute, Nuffield Department of Medicine, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Day', 'Affiliation': 'National Infection Service, Public Health England, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Aanensen', 'Affiliation': 'Centre for Genomic Pathogen Surveillance, Big Data Institute, Nuffield Department of Medicine, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Golparian', 'Affiliation': 'WHO Collaborating Centre for Gonorrhoea and Other STIs, National Reference Laboratory for STIs, Department of Laboratory Medicine, Microbiology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Jacobsson', 'Affiliation': 'WHO Collaborating Centre for Gonorrhoea and Other STIs, National Reference Laboratory for STIs, Department of Laboratory Medicine, Microbiology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Michelle J', 'Initials': 'MJ', 'LastName': 'Cole', 'Affiliation': 'National Infection Service, Public Health England, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkab024'] 2130,33588086,Shoe-stiffening inserts for first metatarsophalangeal joint osteoarthritis: a randomised trial.,"OBJECTIVE To evaluate the efficacy of carbon-fibre shoe-stiffening inserts in individuals with first metatarsophalangeal joint osteoarthritis. DESIGN This was a randomised, sham-controlled, participant- and assessor-blinded trial. One hundred participants with first metatarsophalangeal joint osteoarthritis received rehabilitation therapy and were randomised to receive either carbon fibre shoe-stiffening inserts (n = 49) or sham inserts (n = 51). The primary outcome measure was the Foot Health Status Questionnaire (FHSQ) pain domain assessed at 12 weeks. RESULTS All 100 randomised participants (mean age 57.5 (SD 10.3) years; 55 (55%) women) were included in the analysis of the primary outcome. At the 12 week primary endpoint, there were 13 drop-outs (7 in the sham insert group and 6 in the shoe-stiffening insert group), giving completion rates of 86 and 88%, respectively. Both groups demonstrated improvements in the FHSQ pain domain score at each follow-up period, and there was a significant between-group difference in favour of the shoe-stiffening insert group (adjusted mean difference of 6.66 points, 95% CI 0.65 to 12.67, P = 0.030). There were no between-group differences for the secondary outcomes, although global improvement was more common in the shoe-stiffening insert group compared to the sham insert group (61 vs 34%, RR 1.73, 95% CI 1.05 to 2.88, P = 0.033; number needed to treat 4, 95% CI 2 to 16). CONCLUSION Carbon-fibre shoe-stiffening inserts were more effective at reducing foot pain than sham inserts at 12 weeks. These results support the use of shoe-stiffening inserts for the management of this condition, although due to the uncertainty around the effect on the primary outcome, some individuals may not experience a clinically worthwhile improvement.",2021,"CONCLUSION Carbon-fibre shoe-stiffening inserts were more effective at reducing foot pain than sham inserts at 12 weeks.","['One hundred participants with first metatarsophalangeal joint osteoarthritis received', 'first metatarsophalangeal joint osteoarthritis', 'All 100 randomised participants (mean age 57.5 (SD 10.3) years; 55 (55%) women', 'individuals with first metatarsophalangeal joint osteoarthritis']","['carbon-fibre shoe-stiffening inserts', 'carbon fibre shoe-stiffening inserts', 'rehabilitation therapy']","['global improvement', 'FHSQ pain domain score', 'Foot Health Status Questionnaire (FHSQ) pain domain assessed at 12 weeks', 'foot pain', 'giving completion rates']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0025589', 'cui_str': 'Metatarsophalangeal joint structure'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0108411', 'cui_str': 'Carbon fiber'}, {'cui': 'C0036988', 'cui_str': 'Shoes'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0016512', 'cui_str': 'Foot pain'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",100.0,0.290855,"CONCLUSION Carbon-fibre shoe-stiffening inserts were more effective at reducing foot pain than sham inserts at 12 weeks.","[{'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'Munteanu', 'Affiliation': 'Discipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria, 3086, Australia; La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria, 3086, Australia.'}, {'ForeName': 'K B', 'Initials': 'KB', 'LastName': 'Landorf', 'Affiliation': 'Discipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria, 3086, Australia; La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria, 3086, Australia.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'McClelland', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria, 3086, Australia; Discipline of Physiotherapy, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria, 3086, Australia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Roddy', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, Staffordshire, ST5 5BG, United Kingdom; Haywood Academic Rheumatology Centre, Midlands Partnership NHS Foundation Trust, Haywood Hospital, Burslem, Staffordshire, ST6 7AG, United Kingdom.'}, {'ForeName': 'F M', 'Initials': 'FM', 'LastName': 'Cicuttini', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, Victoria, 3004, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shiell', 'Affiliation': 'School of Psychology and Public Health, La Trobe University, Melbourne, Victoria, 3086, Australia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Auhl', 'Affiliation': 'Discipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria, 3086, Australia; La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria, 3086, Australia.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Allan', 'Affiliation': 'Discipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria, 3086, Australia; La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria, 3086, Australia.'}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Buldt', 'Affiliation': 'Discipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria, 3086, Australia; La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria, 3086, Australia.'}, {'ForeName': 'H B', 'Initials': 'HB', 'LastName': 'Menz', 'Affiliation': 'Discipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria, 3086, Australia; La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria, 3086, Australia; Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, Staffordshire, ST5 5BG, United Kingdom. Electronic address: h.menz@latrobe.edu.au.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2021.02.002'] 2131,33588084,The cross-sectional and longitudinal associations of dietary patterns with knee symptoms and MRI detected structure in patients with knee osteoarthritis.,"OBJECTIVES To examine the cross-sectional and longitudinal associations of dietary patterns with knee symptoms and structures in patients with knee osteoarthritis (OA). METHODS Participants with symptomatic knee OA were recruited from a randomised, placebo-controlled trial conducted in Tasmania (N = 259) and Victoria (N = 133). Diet was assessed by the Anti-Cancer Council of Victoria food frequency questionnaire. Factor analysis was used to identify dietary patterns. Knee symptoms were assessed using Western Ontario and McMaster Universities Arthritis Index (WOMAC) and structures using MRI. Multivariable linear regressions were used to examine associations. RESULTS Three dietary patterns (""high-fat"", ""healthy"" and ""mixed"") were identified in whole sample. Participants with higher ""healthy pattern"" score had lower total WOMAC, pain, function and stiffness scores at baseline but the associations were not significant over 24 months. Three (""western"", ""vegetable and meat"" and ""mediterranean"") and two (""processed"" and ""vegetable"") patterns were identified in Tasmania and Victoria, respectively. Cross-sectionally, only ""mediterranean pattern"" and ""vegetable pattern"" scores were significantly and negatively associated with total WOMAC or function scores. Longitudinally, participants with higher ""western pattern"" had worsening function (β: 0.35, 95%CI: 0.03, 0.67) and total WOMAC (β: 0.40, 95%CI: 0.07, 0.72) scores; furthermore, ""vegetable pattern"" was associated with decreased WOMAC stiffness score (β: -0.47, 95%CI: -0.93, -0.02). In contrast, dietary patterns were largely not associated with structural changes. CONCLUSION Some healthy dietary patterns were associated with reduced joint symptoms but dietary patterns were not associated with joint structure in this sample with knee OA. Further studies are required to confirm these findings.",2021,"Participants with higher ""healthy pattern"" score had lower total WOMAC, pain, function and stiffness scores at baseline but the associations were not significant over 24 months.","['Participants with symptomatic knee OA', 'patients with knee osteoarthritis', 'N=259) and Victoria (N=133', 'patients with knee osteoarthritis (OA']","['placebo', 'Tasmania']","['total WOMAC or function scores', 'Knee symptoms', 'total WOMAC', 'worsening function', 'total WOMAC, pain, function and stiffness scores', 'mediterranean pattern"" and ""vegetable pattern"" scores', 'Western Ontario and McMaster Universities Arthritis Index (WOMAC) and structures using MRI', 'WOMAC stiffness score']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039335', 'cui_str': 'Tasmania'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]",,0.0336802,"Participants with higher ""healthy pattern"" score had lower total WOMAC, pain, function and stiffness scores at baseline but the associations were not significant over 24 months.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'Department of Rheumatology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, PR China; Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Winzenberg', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Cicuttini', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Victoria, Australia.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Wluka', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Victoria, Australia.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Antony', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Aitken', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Blizzard', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ding', 'Affiliation': 'Department of Rheumatology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, PR China; Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia; Clinical Research Centre, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, PR China. Electronic address: Changhai.Ding@utas.edu.au.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.12.023'] 2132,33596623,Transepithelial Laser versus Alcohol Assisted Photorefractive Keratectomy Safety and Efficacy: 1-Year Follow-up of a Contralateral Eye Study.,"PURPOSE To compare single-step transepithelial photorefractive keratectomy (TPRK) to conventional alcohol assisted epithelial removal then photorefractive keratectomy (AAPRK) regarding pain, epithelial healing, visual acuity, corneal haze measured subjectively and objectively, higher order aberrations changes, contrast sensitivity and vector analysis of astigmatic correction with one year follow-up. METHODS A prospective double-blind randomized study of 29 subjects (58 eyes) who underwent myopic aberration-free laser correction by smart pulse technology using Schwind Amaris 1050 Hz with 1-year follow-up. Right eye was randomly treated by AAPRK or TPRK. Postoperative assessment was performed on day 1 and 3, at 1st week, and 1st, 3rd, 6th, and 12th months. Patients were assessed for pain, epithelial healing, visual acuity, corneal haze, astigmatic correction, higher order aberrations and contrast sensitivity. RESULTS Epithelial healing was complete by the 3rd day in 62.1% of AAPRK eyes and in 89.7% of TPRK eyes. First day postoperative pain was higher in TPRK group (p = 0.0134). The decimal uncorrected visual acuity at 12 months was 1.47 ± 0.39 and 1.57 ± 0.38 in the AAPRK and TPRK groups respectively (p = 0.3719). Post-photorefractive keratectomy haze reached a final level of 0.04 ± 0.14 and 0.02 ± 0.1 in AAPRK and TPRK groups respectively (p = 0.5607). Contrast sensitivity was comparable in low and high frequency cycles per degree. Vector analysis of astigmatic correction showed correction index at one year of 0.99 and 1.05 for AAPRK and TPRK groups respectively. CONCLUSIONS Alcohol assisted and transepithelial photorefractive keratectomy have comparable results regarding safety and efficacy.",2021,First day postoperative pain was higher in TPRK group (P= 0.0134).,['29 subjects (58 eyes) who underwent'],"['AAPRK or TPRK', 'Transepithelial Laser versus Alcohol', 'single-step transepithelial PRK (TPRK', 'myopic aberration-free laser correction by Smart Pulse Technology using Schwind Amaris 1050Hz (SCHWIND eye-tech-solutions GmbH, Kleinostheim, Germany) with one year follow-up']","['pain, epithelial healing, visual acuity, corneal haze, astigmatic correction, higher order aberrations and contrast sensitivity', 'postoperative pain', 'safety and efficacy', 'Decimal uncorrected visual acuity', 'Epithelial healing', 'Contrast sensitivity', 'correction index']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0022772', 'cui_str': ""Democratic people's republic of Korea""}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C2714641', 'cui_str': 'Amaris'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0010038', 'cui_str': 'Corneal opacity'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1637380', 'cui_str': 'Uncorrected visual acuity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",29.0,0.0530263,First day postoperative pain was higher in TPRK group (P= 0.0134).,"[{'ForeName': 'Hesham Mohamed', 'Initials': 'HM', 'LastName': 'Gharieb', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': ""Mo'mena Ahmad A"", 'Initials': 'MAA', 'LastName': 'Awad-Allah', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Anas Adel', 'Initials': 'AA', 'LastName': 'Ahmed', 'Affiliation': 'Eye World Hospital, Dokki, Giza, Egypt.'}, {'ForeName': 'Ihab Saad', 'Initials': 'IS', 'LastName': 'Othman', 'Affiliation': 'Eye World Hospital, Dokki, Giza, Egypt.'}]",Korean journal of ophthalmology : KJO,['10.3341/kjo.2020.0105'] 2133,33596155,Fatigability of the external anal sphincter muscles using a novel strength training resistance exercise device.,"Exercises involving pelvic floor muscles including repetitive voluntary contractions of external anal sphincter (EAS) musculature have been used to improve fecal incontinence. Muscle fatigue is a prerequisite for successful strength training. However, muscle fatigue induced by these exercises has not been systematically studied. We aimed to assess the fatigability of EAS muscles during various exercise methods. Twelve nulliparous (21 ± 2.7 yr) women were studied. We evaluated fatigue during 40 repetitive 3-s contractions and 30-s long squeeze contractions both with and without an intra-anal compressible resistant load. The sequence of exercises was randomized. This load was provided by the continence muscles Resistance Exerciser Device. Anal canal pressures were recorded by high-resolution manometry. Exercise against a resistive load showed significant decrease in anal contractile integral (CI) and maximum squeeze pressure during repetitive short squeeze contractions compared with exercise without a load. Linear regression analysis showed a significant negative correlation between anal CI and successive contraction against load, suggesting ""fatigue."" Similar findings were observed for maximum squeeze pressure (slope with load = -4.2, P = 0.0003, vs. without load = -0.9, P = 0.3). Long squeeze contraction against a load was also more susceptible to fatigue than without a load ( P < 0.0001). In conclusion, repetitive contractions against a compressible load induce fatigue and thus have the potential to strengthen the anal sphincter contractile function than contractions without a load. Fatigue rate in long squeeze contraction exercises with a load is significantly faster than that without a load, also indicating greater effectiveness in inducing muscle fatigue. NEW & NOTEWORTHY Fecal incontinence is a distressing disorder with a mainstay of treatment being pelvic floor muscle exercises. However, none of these exercises has proven occurrence of fatigability, which is an important prerequisite for successful muscle strengthening in rehabilitative exercises. In this study, we proved that we can fatigue the external anal sphincter muscles more efficiently by providing a resistive load during anal repetitive short squeeze contractions and long squeeze contraction exercise.",2021,"Long squeeze contraction against a load was also more susceptible to fatigue than without a load (p<0.0001). ",['Twelve nulliparous (21 ± 2.7 yrs'],"['External Anal Sphincter Muscles Using a Novel Strength Training Resistance Exercise Device', '40 repetitive 3 sec contractions and 30 sec long squeeze contractions both with and without an intra-anal compressible resistant load', 'Exercises involving pelvic floor muscles including repetitive voluntary contractions of external anal sphincter (EAS) musculature']","['anal CI and successive contraction against load, suggesting ""fatigue', 'Fatigue rate', 'fecal incontinence', 'maximum squeeze pressure', 'anal contractile integral (CI) and maximum squeeze pressure', 'Anal canal pressures']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C4517635', 'cui_str': '2.7'}]","[{'cui': 'C0224395', 'cui_str': 'External anal sphincter structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0059387', 'cui_str': 'staphylococcal enterotoxin C'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0413258', 'cui_str': 'Barotrauma of descent'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0003461', 'cui_str': 'Anal structure'}, {'cui': 'C0577306', 'cui_str': 'Compressible'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0232725', 'cui_str': 'Contraction of external anal sphincter'}]","[{'cui': 'C0003461', 'cui_str': 'Anal structure'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0443238', 'cui_str': 'Integral'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0413258', 'cui_str': 'Barotrauma of descent'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0227411', 'cui_str': 'Anal canal structure'}]",,0.0715709,"Long squeeze contraction against a load was also more susceptible to fatigue than without a load (p<0.0001). ","[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Mei', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Krupa', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Navjit', 'Initials': 'N', 'LastName': 'Lehal', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Mark K', 'Initials': 'MK', 'LastName': 'Kern', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Benjamin', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Sanvanson', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Shaker', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical College of Wisconsin, Milwaukee, Wisconsin.'}]",American journal of physiology. Gastrointestinal and liver physiology,['10.1152/ajpgi.00456.2020'] 2134,33599773,"Comparison of an Artificial Intelligence-Enabled Patient Decision Aid vs Educational Material on Decision Quality, Shared Decision-Making, Patient Experience, and Functional Outcomes in Adults With Knee Osteoarthritis: A Randomized Clinical Trial.","Importance Decision aids can help inform appropriate selection of total knee replacement (TKR) for advanced knee osteoarthritis (OA). However, few decision aids combine patient education, preference assessment, and artificial intelligence (AI) using patient-reported outcome measurement data to generate personalized estimations of outcomes to augment shared decision-making (SDM). Objective To assess the effect of an AI-enabled patient decision aid that includes education, preference assessment, and personalized outcome estimations (using patient-reported outcome measurements) on decision quality, patient experience, functional outcomes, and process-level outcomes among individuals with advanced knee OA considering TKR in comparison with education only. Design, Setting, and Participants This randomized clinical trial at a single US academic orthopedic practice included 129 new adult patients presenting for OA-related knee pain from March 2019 to January 2020. Data were analyzed from April to May 2020. Intervention Patients were randomized into a group that received a decision aid including patient education, preference assessment, and personalized outcome estimations (intervention group) or a group receiving educational material only (control group) alongside usual care. Main Outcomes and Measures The primary outcome was decision quality, measured using the Knee OA Decision Quality Instrument (K-DQI). Secondary outcomes were collaborative decision-making (assessed using the CollaboRATE survey), patient satisfaction with consultation (using a numerical rating scale), Knee Injury and Osteoarthritis Outcome Score Joint Replacement (KOOS JR) score, consultation time, TKR rate, and treatment concordance. Results A total of 69 patients in the intervention group (46 [67%] women) and 60 patients in the control group (37 [62%] women) were included in the analysis. The intervention group showed better decisional quality (K-DQI mean difference, 20.0%; SE, 3.02; 95% CI, 14.2%-26.1%; P < .001), collaborative decision-making (CollaboRATE, 8 of 69 [12%] vs 28 of 60 [47%] patients below median; P < .001), satisfaction (numerical rating scale, 9 of 65 [14%] vs 19 of 58 [33%] patients below median; P = .01), and improved functional outcomes at 4 to 6 months (mean [SE] KOOS JR, 4.9 [2.24] points higher in intervention group; 95% CI, 0.8-9.0 points; P = .02). The intervention did not significantly affect consultation time (mean [SE] difference, 2.23 [2.18] minutes; P = .31), TKR rates (16 of 69 [23%] vs 7 of 60 [12%] patients; P = .11), or treatment concordance (58 of 69 [84%] vs 44 of 60 [73%] patients; P = .19). Conclusions and Relevance In this randomized clinical trial, an AI-enabled decision aid significantly improved decision quality, level of SDM, satisfaction, and physical limitations without significantly impacting consultation times, TKR rates, or treatment concordance in patients with knee OA considering TKR. Decision aids using a personalized, data-driven approach can enhance SDM in the management of knee OA. Trial Registration ClinicalTrials.gov Identifier: NCT03956004.",2021,"The intervention did not significantly affect consultation time (mean [SE] difference, 2.23 [2.18] minutes; P = .31), TKR rates (16 of 69 [23%] vs 7 of 60 [12%] patients; P = .11), or treatment concordance (58 of 69 [84%] vs 44 of 60 [73%] patients; P = .19). ","['69 patients in the intervention group (46 [67%] women) and 60 patients in the control group (37 [62%] women) were included in the analysis', 'individuals with advanced knee OA considering TKR in comparison with education only', 'patients with knee OA considering TKR', '129 new adult patients presenting for OA-related knee pain from March 2019 to January 2020', 'Adults With Knee Osteoarthritis', 'advanced knee osteoarthritis (OA']","['Artificial Intelligence-Enabled Patient Decision Aid vs Educational Material', 'decision aid including patient education, preference assessment, and personalized outcome estimations (intervention group) or a group receiving educational material only (control group) alongside usual care']","['decision quality, level of SDM, satisfaction, and physical limitations without significantly impacting consultation times, TKR rates', 'consultation time', 'satisfaction (numerical rating scale', 'decision quality, measured using the Knee OA Decision Quality Instrument (K-DQI', 'functional outcomes', 'decisional quality', 'decision quality, patient experience, functional outcomes, and process-level outcomes', 'collaborative decision-making (assessed using the CollaboRATE survey), patient satisfaction with consultation (using a numerical rating scale), Knee Injury and Osteoarthritis Outcome Score Joint Replacement (KOOS JR) score, consultation time, TKR rate, and treatment concordance', 'TKR rates', 'collaborative decision-making']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0185317', 'cui_str': 'Implantation of joint prosthesis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",129.0,0.11832,"The intervention did not significantly affect consultation time (mean [SE] difference, 2.23 [2.18] minutes; P = .31), TKR rates (16 of 69 [23%] vs 7 of 60 [12%] patients; P = .11), or treatment concordance (58 of 69 [84%] vs 44 of 60 [73%] patients; P = .19). ","[{'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Jayakumar', 'Affiliation': 'Dell Medical School at the University of Texas at Austin, Austin.'}, {'ForeName': 'Meredith G', 'Initials': 'MG', 'LastName': 'Moore', 'Affiliation': 'Dell Medical School at the University of Texas at Austin, Austin.'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Furlough', 'Affiliation': 'Dell Medical School at the University of Texas at Austin, Austin.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Uhler', 'Affiliation': 'Dell Medical School at the University of Texas at Austin, Austin.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Andrawis', 'Affiliation': 'Dell Medical School at the University of Texas at Austin, Austin.'}, {'ForeName': 'Karl M', 'Initials': 'KM', 'LastName': 'Koenig', 'Affiliation': 'Dell Medical School at the University of Texas at Austin, Austin.'}, {'ForeName': 'Nazan', 'Initials': 'N', 'LastName': 'Aksan', 'Affiliation': 'Dell Medical School at the University of Texas at Austin, Austin.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Rathouz', 'Affiliation': 'Dell Medical School at the University of Texas at Austin, Austin.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Bozic', 'Affiliation': 'Dell Medical School at the University of Texas at Austin, Austin.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.37107'] 2135,33603241,Neoadjuvant nivolumab or nivolumab plus ipilimumab in operable non-small cell lung cancer: the phase 2 randomized NEOSTAR trial.,"Ipilimumab improves clinical outcomes when combined with nivolumab in metastatic non-small cell lung cancer (NSCLC), but its efficacy and impact on the immune microenvironment in operable NSCLC remain unclear. We report the results of the phase 2 randomized NEOSTAR trial (NCT03158129) of neoadjuvant nivolumab or nivolumab + ipilimumab followed by surgery in 44 patients with operable NSCLC, using major pathologic response (MPR) as the primary endpoint. The MPR rate for each treatment arm was tested against historical controls of neoadjuvant chemotherapy. The nivolumab + ipilimumab arm met the prespecified primary endpoint threshold of 6 MPRs in 21 patients, achieving a 38% MPR rate (8/21). We observed a 22% MPR rate (5/23) in the nivolumab arm. In 37 patients resected on trial, nivolumab and nivolumab + ipilimumab produced MPR rates of 24% (5/21) and 50% (8/16), respectively. Compared with nivolumab, nivolumab + ipilimumab resulted in higher pathologic complete response rates (10% versus 38%), less viable tumor (median 50% versus 9%), and greater frequencies of effector, tissue-resident memory and effector memory T cells. Increased abundance of gut Ruminococcus and Akkermansia spp. was associated with MPR to dual therapy. Our data indicate that neoadjuvant nivolumab + ipilimumab-based therapy enhances pathologic responses, tumor immune infiltrates and immunologic memory, and merits further investigation in operable NSCLC.",2021,Increased abundance of gut Ruminococcus and Akkermansia spp. was associated with MPR to dual therapy.,"['44 patients with operable NSCLC, using major pathologic response (MPR) as the primary endpoint', '37 patients resected on trial, nivolumab and nivolumab\u2009', 'metastatic non-small cell lung cancer (NSCLC', 'operable non-small cell lung cancer']","['nivolumab', 'Ipilimumab', 'neoadjuvant nivolumab or nivolumab\u2009+\u2009ipilimumab', 'Neoadjuvant nivolumab or nivolumab plus ipilimumab', 'ipilimumab', 'nivolumab, nivolumab\u2009+\u2009ipilimumab']","['higher pathologic complete response rates', 'frequencies of effector, tissue-resident memory and effector memory T cells', 'viable tumor', 'MPR rate', 'MPR rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C4543203', 'cui_str': 'Effector'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",,0.23233,Increased abundance of gut Ruminococcus and Akkermansia spp. was associated with MPR to dual therapy.,"[{'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Cascone', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA. tcascone@mdanderson.org.'}, {'ForeName': 'William N', 'Initials': 'WN', 'LastName': 'William', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Annikka', 'Initials': 'A', 'LastName': 'Weissferdt', 'Affiliation': 'Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Cheuk H', 'Initials': 'CH', 'LastName': 'Leung', 'Affiliation': 'Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Heather Y', 'Initials': 'HY', 'LastName': 'Lin', 'Affiliation': 'Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Apar', 'Initials': 'A', 'LastName': 'Pataer', 'Affiliation': 'Thoracic and Cardiovascular Surgery, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Myrna C B', 'Initials': 'MCB', 'LastName': 'Godoy', 'Affiliation': 'Thoracic Imaging, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Brett W', 'Initials': 'BW', 'LastName': 'Carter', 'Affiliation': 'Thoracic Imaging, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Federico', 'Affiliation': 'Melanoma Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Reuben', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Md Abdul Wadud', 'Initials': 'MAW', 'LastName': 'Khan', 'Affiliation': 'Surgical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Dejima', 'Affiliation': 'Translational Molecular Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Francisco-Cruz', 'Affiliation': 'Translational Molecular Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Edwin R', 'Initials': 'ER', 'LastName': 'Parra', 'Affiliation': 'Translational Molecular Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Luisa M', 'Initials': 'LM', 'LastName': 'Solis', 'Affiliation': 'Translational Molecular Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Fujimoto', 'Affiliation': 'Translational Molecular Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Hai T', 'Initials': 'HT', 'LastName': 'Tran', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Kalhor', 'Affiliation': 'Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Frank V', 'Initials': 'FV', 'LastName': 'Fossella', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Frank E', 'Initials': 'FE', 'LastName': 'Mott', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Anne S', 'Initials': 'AS', 'LastName': 'Tsao', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Blumenschein', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Xiuning', 'Initials': 'X', 'LastName': 'Le', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Ferdinandos', 'Initials': 'F', 'LastName': 'Skoulidis', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Kurie', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Altan', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Bonnie S', 'Initials': 'BS', 'LastName': 'Glisson', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Lauren Averett', 'Initials': 'LA', 'LastName': 'Byers', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Yasir Y', 'Initials': 'YY', 'LastName': 'Elamin', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Reza J', 'Initials': 'RJ', 'LastName': 'Mehran', 'Affiliation': 'Thoracic and Cardiovascular Surgery, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Rice', 'Affiliation': 'Thoracic and Cardiovascular Surgery, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Garrett L', 'Initials': 'GL', 'LastName': 'Walsh', 'Affiliation': 'Thoracic and Cardiovascular Surgery, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Wayne L', 'Initials': 'WL', 'LastName': 'Hofstetter', 'Affiliation': 'Thoracic and Cardiovascular Surgery, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Roth', 'Affiliation': 'Thoracic and Cardiovascular Surgery, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Mara B', 'Initials': 'MB', 'LastName': 'Antonoff', 'Affiliation': 'Thoracic and Cardiovascular Surgery, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Humam', 'Initials': 'H', 'LastName': 'Kadara', 'Affiliation': 'Translational Molecular Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Haymaker', 'Affiliation': 'Translational Molecular Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Chantale', 'Initials': 'C', 'LastName': 'Bernatchez', 'Affiliation': 'Melanoma Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Nadim J', 'Initials': 'NJ', 'LastName': 'Ajami', 'Affiliation': 'Genomic Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Jenq', 'Affiliation': 'Genomic Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Padmanee', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Allison', 'Affiliation': 'Immunology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Futreal', 'Affiliation': 'Genomic Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Wargo', 'Affiliation': 'Surgical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Ignacio I', 'Initials': 'II', 'LastName': 'Wistuba', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Swisher', 'Affiliation': 'Thoracic and Cardiovascular Surgery, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'J Jack', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Don L', 'Initials': 'DL', 'LastName': 'Gibbons', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Ara A', 'Initials': 'AA', 'LastName': 'Vaporciyan', 'Affiliation': 'Thoracic and Cardiovascular Surgery, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'John V', 'Initials': 'JV', 'LastName': 'Heymach', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Sepesi', 'Affiliation': 'Thoracic and Cardiovascular Surgery, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",Nature medicine,['10.1038/s41591-020-01224-2'] 2136,33602603,Duration of effect of Biotène spray in patients with symptomatic dry mouth: A pilot study.,"OBJECTIVES The objective of this study was to assess the duration of effect of a single dose of Biotène Moisturizing Spray on xerostomia compared to water spray. STUDY DESIGN This double-blind randomized controlled crossover trial compared the duration of effect of 2 agents on relieving xerostomia in adult patients recruited through convenience sampling. Following a xerostomia questionnaire, qualifying patients with an unstimulated whole saliva flow rate of ≤0.20 mL/min rated their baseline level of discomfort from oral dryness and received a single dose (3 sprays) of Biotène Moisturizing Spray or water (active control). Patients indicated their level of oral discomfort every 15 min and the precise time when relief ceased. After a minimum 48-h washout, patients repeated the exercise with the alternative product. RESULTS The baseline severity of discomfort from oral dryness among qualifying patients was significantly related to their level of hyposalivation (P = .001). The mean duration of effect of Biotène Moisturizing Spray was 27 ± 25 min, which was not significantly different from that for water (26 ± 25 min; P = .88; n = 25). CONCLUSION Biotène Moisturizing Spray and water spray had variable durations of effect averaging approximately 30 min. The results of this pilot study provide guidance regarding anticipated usage and dispensing needs for patients with objective xerostomia. ClinicalTrials.gov NCT03663231.",2021,"The mean duration of effect of Biotène Moisturizing Spray was 27 ± 25 min, which was not significantly different from that for water (26 ± 25 min; P = .88; n = 25). ","['patients with objective xerostomia', 'patients with symptomatic dry mouth', 'adult patients recruited through convenience sampling']","['Biotène Moisturizing Spray and water spray', 'Biotène Moisturizing Spray', 'Biotène spray', 'Biotène Moisturizing Spray or water (active control']","['baseline severity of discomfort from oral dryness', 'relieving xerostomia', 'level of oral discomfort', 'xerostomia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}]","[{'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0399459', 'cui_str': 'Discomfort in mouth'}]",,0.248505,"The mean duration of effect of Biotène Moisturizing Spray was 27 ± 25 min, which was not significantly different from that for water (26 ± 25 min; P = .88; n = 25). ","[{'ForeName': 'Christine Bambi', 'Initials': 'CB', 'LastName': 'Lung', 'Affiliation': 'Dental Resident and Study Sub-PI, Department of General Dentistry, Department of Pediatric Dentistry, University of Rochester-Eastman Institute for Oral Health, Rochester, NY, USA. Electronic address: christine.lung@utoronto.ca.'}, {'ForeName': 'Gene E', 'Initials': 'GE', 'LastName': 'Watson', 'Affiliation': 'Professor, Department of Dentistry, Center for Oral Biology, Department of Pharmacology and Physiology, Department of Environmental Medicine, University of Rochester-Eastman Institute for Oral Health, Rochester, NY, USA.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': 'Dental Resident, Department of General Dentistry, University of Rochester-Eastman Institute for Oral Health, Rochester, NY, USA.'}, {'ForeName': 'Changyong', 'Initials': 'C', 'LastName': 'Feng', 'Affiliation': 'Statistician, Department of Biostatistics and Computational Biology, University of Rochester-Eastman Institute for Oral Health, Rochester, NY, USA.'}, {'ForeName': 'Ralph H', 'Initials': 'RH', 'LastName': 'Saunders', 'Affiliation': 'Professor, Faculty, and Study PI, Department of General Dentistry, Eastman Institute for Oral Health, Rochester, NY, USA.'}]","Oral surgery, oral medicine, oral pathology and oral radiology",['10.1016/j.oooo.2020.12.002'] 2137,33601934,"School-Based Secondary Obesity Prevention for Eight- to Twelve-Year-Olds: Results from the Students, Nurses, and Parents Seeking Healthy Options Together Randomized Trial.","Objective: The primary aim of this randomized controlled trial, conducted in Minneapolis/St. Paul, Minnesota (2014-2019), was to evaluate the effects of a school-based, school nurse-delivered, secondary obesity prevention intervention to reduce excess weight gain among preadolescent children with obesity or at risk of developing obesity. Methods: Parent/child dyads ( n  = 132) were randomized to the 9-month Students, Nurses, and Parents Seeking Healthy Options Together (SNAPSHOT) intervention (32.5 contact hours) or newsletter-only control group. Eligible children were 8 to 12 years old, proficient in English, and with a BMI ≥75th percentile, calculated using height/weight reported by a parent, school nurse, or clinician. The primary outcome was child BMI for sex/age z -score (BMI z ) at postintervention (12 months) and follow-up (24 months). Results: Among children, 63% were non-White, 51% were male, and 51% with obesity, including 21% with severe obesity. Among families, 59% received economic assistance and 30% reported food insecurity. The mean number of intervention contact hours received was 20 (range: 0-32.5). Among dyads ( n  = 54) receiving the intervention, parents were very satisfied/satisfied with SNAPSHOT and SNAPSHOT staff, 96% and 100%, respectively, and very likely/likely (97%) to recommend SNAPSHOT to others. Most (70%) children liked the kid group sessions ""a lot."" In an intent-to-treat analysis, there were no significant between-group differences in child BMI z at 12 [0.04; 95% confidence interval (CI) -0.07 to 0.16] or 24 months (0.06; 95% CI -0.08 to 0.20), with participant retention of 92% and 93%, respectively. Conclusions: The SNAPSHOT intervention was well received, but did not improve BMI in a mostly diverse, low-income preadolescent population. Approaches to intervention delivery that are feasible, maximize accessibility, and optimize clinician and school nurse collaboration warrant consideration. Clinical trial registration identifier NCT02029976.",2021,"Among dyads ( n  = 54) receiving the intervention, parents were very satisfied/satisfied with SNAPSHOT and SNAPSHOT staff, 96% and 100%, respectively, and very likely/likely (97%) to recommend SNAPSHOT to others.","['children, 63% were non-White, 51% were male, and 51% with obesity, including 21% with severe obesity', 'Methods: Parent/child dyads ( n \u2009=\u2009132) were randomized to the 9-month Students, Nurses, and Parents Seeking Healthy Options', 'School-Based Secondary Obesity Prevention for 8- to 12-Year-Olds', 'Eligible children were 8 to 12 years old, proficient in English, and with a BMI ≥75th percentile, calculated using height/weight reported by a parent, school nurse, or clinician', 'Students, Nurses, and Parents Seeking Healthy Options', 'preadolescent children with obesity or at risk of developing obesity']","['SNAPSHOT intervention', 'SNAPSHOT) intervention (32.5 contact hours) or newsletter-only control group', 'school-based, school nurse-delivered, secondary obesity prevention intervention']","['z -score (BMI z ', 'child BMI for sex/age', 'BMI', 'child BMI z']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4534427', 'cui_str': 'Proficient in English'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0302833', 'cui_str': 'School nurse'}, {'cui': 'C1444711', 'cui_str': 'Pre-teen'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517710', 'cui_str': '32.5'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0027988', 'cui_str': 'Newsletters'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0302833', 'cui_str': 'School nurse'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",,0.077969,"Among dyads ( n  = 54) receiving the intervention, parents were very satisfied/satisfied with SNAPSHOT and SNAPSHOT staff, 96% and 100%, respectively, and very likely/likely (97%) to recommend SNAPSHOT to others.","[{'ForeName': 'Martha Y', 'Initials': 'MY', 'LastName': 'Kubik', 'Affiliation': 'School of Nursing, College of Health and Human Services, George Mason University, Fairfax, VA, USA.'}, {'ForeName': 'Jiwoo', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Jayne A', 'Initials': 'JA', 'LastName': 'Fulkerson', 'Affiliation': 'School of Nursing, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Olga V', 'Initials': 'OV', 'LastName': 'Gurvich', 'Affiliation': 'School of Nursing, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Sirard', 'Affiliation': 'Department of Kinesiology, University of Massachusetts Amherst, Amherst, MA, USA.'}]",Childhood obesity (Print),['10.1089/chi.2020.0321'] 2138,33601395,Influence of Medical Compression Stockings on Skin Hydration in Mainly Health Care Givers with Occupational Leg Symptoms and Edema.,"BACKGROUND AND OBJECTIVE Although compression therapy is a very effective therapy in reducing stasis-induced complaints, the wearing comfort is not always as requested. Most frequent problems are dryness of the skin and itching. This randomized, cross-over trial investigated 33 healthy participants and compared 2 different medical compression stockings: conventional stockings (type A = MCS) versus compression stockings with integrated care emulsion (type B = MCS-SkC). METHODS Participants were divided into 2 cohorts. Both compression types were worn one after the other, 1 week each. The cohorts were named according to the sequence of the wearing periods (cohort AB/BA). PRIMARY OUTCOME skin hydration. SECONDARY OUTCOMES transepidermal water loss (TEWL), skin roughness, leg volume, interface pressure, and questionnaires about stasis-induced complaints and wearing comfort. RESULTS Skin hydration: significant reduction after wearing MCS in both cohorts (p < 0.001); preservation of skin moisture after wearing MCS-SkC (p = 0.546 and p = 0.1631). TEWL: significant increase after wearing MCS (p = 0.007 and p = 0.0031); significant reduction by wearing MCS-SkC (p = 0.006 and p = 0.0005). Skin roughness: significant increase after wearing MCS (p = 0.0015 and p = 0.010), and nonsignificant decrease of skin roughness after wearing MCS-SkC (p = 0.933 and p = 0.4570). Leg volume: significantly reduced with both stockings (p = 0.004 and p = 0.0047). Regarding stasis-induced complaints, both stockings achieved good results. CONCLUSIONS Both compression stockings are appropriate to reduce leg edema and minimize leg symptoms. MCS-SkC helps to obtain the natural skin barrier function in preserving the epidermal water content and reducing the TEWL.",2021,Leg volume: significantly reduced with both stockings (p = 0.004 and p = 0.0047).,"['Mainly Health Care Givers with Occupational Leg Symptoms and Edema', 'Participants were divided into 2 cohorts', '33 healthy participants and compared 2 different']","['compression stockings', 'medical compression stockings: conventional stockings (type A = MCS) versus compression stockings with integrated care emulsion (type B = MCS-SkC', 'compression therapy', 'Medical Compression Stockings']","['transepidermal water loss (TEWL), skin roughness, leg volume, interface pressure, and questionnaires about stasis-induced complaints and wearing comfort', 'leg edema and minimize leg symptoms', 'preservation of skin moisture', 'Leg volume', 'skin hydration', 'skin roughness']","[{'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0038348', 'cui_str': 'Compression stocking'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0445269', 'cui_str': 'Socks'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0036221', 'cui_str': 'Mast cell sarcoma'}, {'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0859038', 'cui_str': 'Skin roughness'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0333138', 'cui_str': 'Stasis'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0235886', 'cui_str': 'Leg edema'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}]",33.0,0.0148563,Leg volume: significantly reduced with both stockings (p = 0.004 and p = 0.0047).,"[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Mayer-Yousif', 'Affiliation': 'Department of Dermatology, Universitätsmedizin Greifswald, Greifswald, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Konschake', 'Affiliation': 'Department of Dermatology, Universitätsmedizin Greifswald, Greifswald, Germany.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Haase', 'Affiliation': 'Department of Dermatology, Universitätsmedizin Greifswald, Greifswald, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Jünger', 'Affiliation': 'Department of Dermatology, Universitätsmedizin Greifswald, Greifswald, Germany, Michael.Juenger@med.uni-greifswald.de.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Riebe', 'Affiliation': 'Department of Dermatology, Universitätsmedizin Greifswald, Greifswald, Germany.'}]",Skin pharmacology and physiology,['10.1159/000512642'] 2139,33601285,A tailored mindfulness-based program for resident physicians: A qualitative study.,"BACKGROUND Diminished well-being is prevalent in resident physicians. This qualitative study explored the effects of a tailored mindfulness-based program (MBP) aimed at increasing resident physicians' well-being. A second goal was to compare the MBP with an active control group. MATERIALS AND METHODS We conducted interviews with 35 resident physicians: 21 physicians attended an eight-week MBP (intervention group) and 14 physicians received text-based information about mindfulness for self-study (control group). The interviews were analyzed using thematic analysis. RESULTS Participants in the intervention group reported that the MBP helped them integrate mindfulness into their everyday life, increased their self-awareness, equanimity and well-being, and had positive effects on their self-care and interactions with patients. In the control group, the perceived effects were minor. CONCLUSION A tailored mindfulness-based program can help resident physicians care for their own well-being during medical residency and can have positive effects on their interactions with patients.",2021,"RESULTS Participants in the intervention group reported that the MBP helped them integrate mindfulness into their everyday life, increased their self-awareness, equanimity and well-being, and had positive effects on their self-care and interactions with patients.",['We conducted interviews with 35 resident physicians: 21 physicians attended an eight-week'],"['MBP (intervention group) and 14 physicians received text-based information about mindfulness for self-study (control group', 'tailored mindfulness-based program (MBP']","['MBP helped them integrate mindfulness into their everyday life, increased their self-awareness, equanimity and well-being']","[{'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C3146223', 'cui_str': 'Awareness of self'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0147913,"RESULTS Participants in the intervention group reported that the MBP helped them integrate mindfulness into their everyday life, increased their self-awareness, equanimity and well-being, and had positive effects on their self-care and interactions with patients.","[{'ForeName': 'Vanessa M', 'Initials': 'VM', 'LastName': 'Aeschbach', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Hauptstraße 8, 79104, Freiburg, Germany; Department of Occupational and Consumer Psychology, Institute of Psychology, University of Freiburg, Engelbergerstraße 41, 79106, Freiburg, Germany. Electronic address: vanessa.aeschbach@uniklinik-freiburg.de.'}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'Fendel', 'Affiliation': 'Department of Occupational and Consumer Psychology, Institute of Psychology, University of Freiburg, Engelbergerstraße 41, 79106, Freiburg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Hauptstraße 8, 79104, Freiburg, Germany.'}, {'ForeName': 'Anja S', 'Initials': 'AS', 'LastName': 'Göritz', 'Affiliation': 'Department of Occupational and Consumer Psychology, Institute of Psychology, University of Freiburg, Engelbergerstraße 41, 79106, Freiburg, Germany.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101333'] 2140,33600915,Baricitinib in patients with moderate-to-severe atopic dermatitis: Results from a randomized monotherapy phase 3 trial in the United States and Canada (BREEZE-AD5).,"BACKGROUND Baricitinib, an oral selective Janus kinase 1/Janus kinase 2 inhibitor, is being studied for moderate-to-severe atopic dermatitis (AD) in adults. OBJECTIVE To evaluate the efficacy and safety of baricitinib monotherapy in a North American phase 3 trial (BREEZE-AD5/NCT03435081) of adults with moderate-to-severe AD who responded inadequately or were intolerant to topical therapy. METHODS Patients (N = 440) were randomized 1:1:1 to once-daily placebo or baricitinib (1 mg or 2 mg). The primary endpoint was the proportion of patients achieving ≥75% reduction in the Eczema Area and Severity Index at week 16. A key secondary endpoint was the proportion of patients achieving a validated Investigator Global Assessment for AD score of 0 (clear)/1(almost clear) with ≥2-point improvement. RESULTS At week 16, the proportion of patients achieving Eczema Area and Severity Index was 8%, 13%, and 30% (P < .001, 2 mg vs placebo) and those with a validated Investigator Global Assessment for AD score of 0/1 were 5%, 13%, and 24% (P < .001, 2 mg vs placebo) for placebo, baricitinib 1 mg, and baricitinib 2 mg, respectively. Safety findings were similar to those of other baricitinib AD studies. LIMITATIONS Short-term clinical trial results may not be generalizable to real-world settings. CONCLUSION Baricitinib was efficacious for patients with moderate-to-severe AD with no new safety findings over 16 weeks.",2021,Baricitinib was efficacious for patients with moderate-to-severe AD with no new safety findings over 16 weeks.,"['patients with moderate-to-severe AD', 'adults with moderate-to-severe AD who responded inadequately or were intolerant to topical therapy', 'patients with moderate-to-severe atopic dermatitis', 'Patients (N=440', 'moderate-to-severe atopic dermatitis (AD) in adults']","['baricitinib monotherapy', 'placebo or baricitinib', 'placebo']","['proportion of patients achieving ≥75% reduction in the Eczema Area and Severity Index (EASI75', 'proportion of patients achieving EASI75', 'efficacy and safety', 'proportion of patients achieving a validated Investigator Global Assessment for AD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}]",440.0,0.272111,Baricitinib was efficacious for patients with moderate-to-severe AD with no new safety findings over 16 weeks.,"[{'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Oregon Health and Science University, Portland, Oregon. Electronic address: simpsone@ohsu.edu.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Forman', 'Affiliation': 'ForCare Clinical Research, Tampa, Florida.'}, {'ForeName': 'Jonathan I', 'Initials': 'JI', 'LastName': 'Silverberg', 'Affiliation': 'George Washington University, Washington, DC.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Zirwas', 'Affiliation': 'Bexley Dermatology Research Clinic, Bexley, Ohio.'}, {'ForeName': 'Emanual', 'Initials': 'E', 'LastName': 'Maverakis', 'Affiliation': 'University of California Davis, Sacramento, California.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Han', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Guttman-Yassky', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Marnell', 'Affiliation': 'Medical Center for Clinical Research-Wake Research, San Diego, California.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bissonnette', 'Affiliation': 'Innovaderm Research, Montreal, Quebec, Canada.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Waibel', 'Affiliation': 'Miami Dermatology and Laser Institute, Miami, Florida.'}, {'ForeName': 'Fabio P', 'Initials': 'FP', 'LastName': 'Nunes', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'DeLozier', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Robinette', 'Initials': 'R', 'LastName': 'Angle', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Gamalo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Holzwarth', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Orin', 'Initials': 'O', 'LastName': 'Goldblum', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Jinglin', 'Initials': 'J', 'LastName': 'Zhong', 'Affiliation': 'IQVIA, Morrisville, North Carolina.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Janes', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Papp', 'Affiliation': 'K Papp Clinical Research and Probity Medical Research, Waterloo, Ontario, Canada.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2021.02.028'] 2141,33548747,"Effect of therapeutic touch on daytime sleepiness, stress and fatigue among students of nursing and midwifery: A randomized sham-controlled trial.","OBJECTIVES This study was conducted to assess the effect of therapeutic touch on stress, daytime sleepiness, sleep quality and fatigue among students of nursing and midwifery. METHODS 96 students were randomized into three groups: the therapeutic touch (TT) group, the sham therapeutic touch (STT) group, and the control group. In this randomized sham-controlled study, the TT group was subjected to therapeutic touch twice a week for four weeks with each session lasting 20 min. RESULTS When the TT group was compared to the STT and control groups following the intervention, the decrease in the levels of stress (p < 0.001), fatigue (p < 0.001) and daytime sleepiness (p < 0.001), and the increase in the sleep quality (p < 0.001) were found to be significant. CONCLUSION It was found that TT, which is one form of complementary therapy, was relatively effective in decreasing the levels of stress, fatigue and daytime sleepiness, and in increasing the sleep quality of university students of nursing and midwifery.",2021,"It was found that TT, which is one form of complementary therapy, was relatively effective in decreasing the levels of stress, fatigue and daytime sleepiness, and in increasing the sleep quality of university students of nursing and midwifery.","['students of nursing and midwifery', '96 students']","['STT', 'therapeutic touch', 'therapeutic touch (TT) group, the sham therapeutic touch (STT']","['stress, daytime sleepiness, sleep quality and fatigue', 'daytime sleepiness', 'levels of stress, fatigue and daytime sleepiness', 'sleep quality', 'fatigue', 'daytime sleepiness, stress and fatigue', 'levels of stress']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0026082', 'cui_str': 'Midwifery'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]",96.0,0.0270069,"It was found that TT, which is one form of complementary therapy, was relatively effective in decreasing the levels of stress, fatigue and daytime sleepiness, and in increasing the sleep quality of university students of nursing and midwifery.","[{'ForeName': 'Birgül', 'Initials': 'B', 'LastName': 'Vural Doğru', 'Affiliation': 'Mersin University, Faculty of Nursing, Internal Nursing Department, Mersin, Turkey. Electronic address: bvuraldogru@gmail.com.'}, {'ForeName': 'Hediye', 'Initials': 'H', 'LastName': 'Utli', 'Affiliation': 'Mardin Artuklu University, Elderly Care Department, Mardin, Turkey. Electronic address: hediyeutli@gmail.com.'}, {'ForeName': 'Fisun', 'Initials': 'F', 'LastName': 'Şenuzun Aykar', 'Affiliation': 'Izmir Tinaztepe University, Faculty of Health Sciences, Nursing Department, Izmir, Turkey. Electronic address: fisunsenuzun@gmail.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101322'] 2142,33555332,Effect of Wearing a Novel Electronic Wearable Device on Hand Hygiene Compliance Among Health Care Workers: A Stepped-Wedge Cluster Randomized Clinical Trial.,"Importance Hand hygiene (HH) is essential to prevent hospital-acquired infections. Objective To determine whether providing real-time feedback on a simplified HH action improves compliance with the World Health Organization's ""5 Moments"" and the quality of the HH action. Design, Setting, and Participants This open-label, cluster randomized, stepped-wedge clinical trial was conducted between June 1, 2017, and January 6, 2018 (with a follow-up in March 2018), in a geriatric hospital of the University of Geneva Hospitals, Switzerland. All 12 wards and 97 of 306 eligible health care workers (HCWs) volunteered to wear a novel electronic wearable device that delivered real-time feedback on duration of hand rubbing and application of a hand-sized customized volume of alcohol-based handrub (ABHR). Interventions This study had 3 sequential periods: baseline (no device), transition (device monitoring without feedback), and intervention (device monitoring and feedback). The start of the transition period was randomly allocated based on a computer-generated block randomization. Main Outcomes and Measures The primary outcome was HH compliance, according to the direct observation method during intervention as compared with baseline. Secondary outcomes included the volume of ABHR and duration of hand rubbing measured by the device during intervention as compared with transition. Results All wards and respective HCWs were evenly assigned to group 1 (26 participants), 2 (22 participants), 3 (25 participants), or 4 (24 participants). Twelve HCWs did not fully complete the intervention but were included in the analysis. During 759 observation sessions, 6878 HH opportunities were observed. HH compliance at intervention (62.9%; 95% CI, 61.1%-64.7%) was lower than at baseline (66.6%; 95% CI, 64.8%-68.4%). After adjusting for covariates, HH compliance was not different between periods (odds ratio, 1.03; 95% CI, 0.75-1.42; P = .85). Days since study onset (OR, 0.997; 95% CI, 0.994-0.998; P < .001), older age (OR, 0.97; 95% CI, 0.95-0.99; P = .015), and workload (OR, 0.29; 95% CI, 0.20-0.41; P < .001) were independently associated with reduced HH compliance. The median (interquartile range) volume of ABHR and duration of hand rubbing in transition and intervention increased from 1.12 (0.76-1.68) mL to 1.71 (1.01-2.76) mL and from 6.5 (4.5-10.5) seconds to 8 (4.5-15.5) seconds, respectively. There were no serious adverse events. Conclusions and Relevance The use of this device did not change HH compliance, but increased the duration of hand rubbing and volume of ABHR used by HCWs. Trial Registration isrctn.org Identifier: ISRCTN25430066.",2021,"HH compliance at intervention (62.9%; 95% CI, 61.1%-64.7%) was lower than at baseline (66.6%; 95% CI, 64.8%-68.4%).","['All 12 wards and 97 of 306 eligible health care workers (HCWs) volunteered to wear a', 'Health Care Workers']","['simplified HH action', 'Importance\n\n\nHand hygiene (HH', 'transition (device monitoring without feedback), and intervention (device monitoring and feedback', 'Wearing a Novel Electronic Wearable Device', 'novel electronic wearable device that delivered real-time feedback on duration of hand rubbing and application of a hand-sized customized volume of alcohol-based handrub (ABHR']","['duration of hand rubbing and volume of ABHR', 'median (interquartile range) volume of ABHR and duration of hand rubbing in transition and intervention', 'volume of ABHR and duration of hand rubbing measured by the device during intervention as compared with transition', 'HH compliance', 'reduced HH compliance']","[{'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C4505348', 'cui_str': 'Wearable Technology'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",,0.160312,"HH compliance at intervention (62.9%; 95% CI, 61.1%-64.7%) was lower than at baseline (66.6%; 95% CI, 64.8%-68.4%).","[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pires', 'Affiliation': 'Infection Control Programme and World Health Organization Collaborating Centre on Patient Safety-Infection Control & Improving Practices, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Angele', 'Initials': 'A', 'LastName': 'Gayet-Ageron', 'Affiliation': 'Infection Control Programme and World Health Organization Collaborating Centre on Patient Safety-Infection Control & Improving Practices, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Guitart', 'Affiliation': 'Infection Control Programme and World Health Organization Collaborating Centre on Patient Safety-Infection Control & Improving Practices, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Yves-Alain', 'Initials': 'YA', 'LastName': 'Robert', 'Affiliation': 'iQati, Sion, Switzerland.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Fankhauser', 'Affiliation': 'Infection Control Programme and World Health Organization Collaborating Centre on Patient Safety-Infection Control & Improving Practices, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Ermira', 'Initials': 'E', 'LastName': 'Tartari', 'Affiliation': 'Infection Control Programme and World Health Organization Collaborating Centre on Patient Safety-Infection Control & Improving Practices, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Peters', 'Affiliation': 'Infection Control Programme and World Health Organization Collaborating Centre on Patient Safety-Infection Control & Improving Practices, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Funda', 'Initials': 'F', 'LastName': 'Tymurkaynak', 'Affiliation': 'Infection Control Programme and World Health Organization Collaborating Centre on Patient Safety-Infection Control & Improving Practices, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Fourquier', 'Affiliation': ""Haute école du paysage, d'ingénierie et d'architecture de Genève (HEPIA), Geneva, Switzerland.""}, {'ForeName': 'Herve', 'Initials': 'H', 'LastName': 'Soule', 'Affiliation': 'Infection Control Programme and World Health Organization Collaborating Centre on Patient Safety-Infection Control & Improving Practices, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Beuchat', 'Affiliation': ""Haute école du paysage, d'ingénierie et d'architecture de Genève (HEPIA), Geneva, Switzerland.""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Bellissimo-Rodrigues', 'Affiliation': 'Infection Control Programme and World Health Organization Collaborating Centre on Patient Safety-Infection Control & Improving Practices, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Martin', 'Affiliation': 'Infection Control Programme and World Health Organization Collaborating Centre on Patient Safety-Infection Control & Improving Practices, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Zingg', 'Affiliation': 'Infection Control Programme and World Health Organization Collaborating Centre on Patient Safety-Infection Control & Improving Practices, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Pittet', 'Affiliation': 'Infection Control Programme and World Health Organization Collaborating Centre on Patient Safety-Infection Control & Improving Practices, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.35331'] 2143,33555314,Comparison of Corticosteroid Tapering Regimens in Myasthenia Gravis: A Randomized Clinical Trial.,"Importance The tapering of prednisone therapy in generalized myasthenia gravis (MG) presents a therapeutic dilemma; however, the recommended regimen has not yet been validated. Objective To compare the efficacy of the standard slow-tapering regimen of prednisone therapy with a rapid-tapering regimen. Design From June 1, 2009, to July 31, 2013, a multicenter, parallel, single-blind randomized trial was conducted to compare 2 regimens of prednisone tapering. Data analysis was conducted from February 18, 2019, to January 23, 2020. A total of 2291 adults with a confirmed diagnosis of moderate to severe generalized MG at 7 specialized centers in France were assessed for eligibility. Interventions The slow-tapering arm included a gradual increase of the prednisone dose to 1.5 mg/kg every other day and a slow decrease once minimal manifestation status of MG was attained. The rapid-tapering arm consisted of immediate high-dose daily administration of prednisone, 0.75 mg/kg, followed by an earlier and rapid decrease once improved MG status was attained. Azathioprine, up to a maximum dose of 3 mg/kg/d, was prescribed for all participants. Main Outcomes and Measures The primary outcome was attainment of minimal manifestation status of MG without prednisone at 12 months and without clinical relapse at 15 months. Intention-to-treat analysis was conducted. Results Of the 2291 patients assessed, 2086 did not fulfill the inclusion criteria, 87 declined to participate, and 1 patient registered after trial closure. A total of 117 patients (58 in the slow-tapering arm and 59 in the rapid-tapering arm) were selected for inclusion by MG specialists and were randomized. The population included 62 men (53%); median age was 65 years (interquartile range, 35-69 years). The proportion of patients having met the primary outcome was higher in the rapid- vs slow-tapering arm (23 [39%] vs 5 [9%]), with a risk ratio of 3.61 (95% CI, 1.64-7.97; P < .001) after adjusting for center and thymectomy. The rapid-tapering regimen allowed sparing of a mean of 1898 mg (95% CI, -3121 to -461 mg) of prednisone over 1 year (ie, 5.3 mg/d per patient, P = .03). The number of serious adverse events did not differ significantly between the slow- vs rapid-tapering group (13 [22%] vs 21 [36%], P = .15). Conclusions and Relevance In patients with moderate to severe generalized MG who require high-dose prednisone with azathioprine therapy, rapid tapering of prednisone appears to be feasible, well tolerated, and associated with a good outcome. Trial Registration ClinicalTrials.gov Identifier: NCT00987116.",2021,"The number of serious adverse events did not differ significantly between the slow- vs rapid-tapering group (13 [22%] vs 21 [36%], P = .15). ","['Data analysis was conducted from February 18, 2019, to January 23, 2020', 'The population included 62 men (53%); median age was 65 years (interquartile range, 35-69 years', 'Myasthenia Gravis', '2291 adults with a confirmed diagnosis of moderate to severe generalized MG at 7 specialized centers in France were assessed for eligibility', 'generalized myasthenia gravis (MG', '117 patients (58 in the slow-tapering arm and 59 in the rapid-tapering arm) were selected for inclusion by MG specialists and were randomized', 'patients with moderate to severe generalized MG who require high-dose', '2291 patients assessed']","['prednisone', 'prednisone with azathioprine', 'prednisone tapering', 'Azathioprine', 'Corticosteroid Tapering Regimens', 'prednisone therapy']","['number of serious adverse events', 'attainment of minimal manifestation status of MG without prednisone at 12 months and without clinical relapse']","[{'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia gravis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0472367', 'cui_str': 'Generalized myasthenia'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia gravis'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",2291.0,0.237285,"The number of serious adverse events did not differ significantly between the slow- vs rapid-tapering group (13 [22%] vs 21 [36%], P = .15). ","[{'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Sharshar', 'Affiliation': 'Neuro-anesthesiology and Intensive Care Medicine, GHU-Paris, Sainte-Anne Hospital, Paris-17 Université de Paris, Paris, France.'}, {'ForeName': 'Raphaël', 'Initials': 'R', 'LastName': 'Porcher', 'Affiliation': 'Center for Clinical Epidemiology, Assistance Publique Hôpitaux de Paris, Hôtel Dieu Hospital, University Paris Descartes-France, Paris, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Demeret', 'Affiliation': 'Department of Neurology, Neuro-ICU, APHP-Paris-Sorbonne University, Pitié-Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Tranchant', 'Affiliation': 'Department of Neurology, University Hospital, Strasbourg, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Gueguen', 'Affiliation': 'Department of Neurology, Rothschild Ophthalmologic Foundation, Paris, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Eymard', 'Affiliation': 'Department of Neurology, Neuro-ICU, APHP-Paris-Sorbonne University, Pitié-Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Nadaj-Pakleza', 'Affiliation': 'Department of Neurology, University Hospital, Strasbourg, France.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Spinazzi', 'Affiliation': 'France Department of Neurology, University Hospital, Angers, France.'}, {'ForeName': 'Lamiae', 'Initials': 'L', 'LastName': 'Grimaldi', 'Affiliation': 'Clinical Research Unit, Ambroise Paré Hospital, University of Versailles Saint-Quentin en Yvelines, Boulogne-Billancourt, France.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Birnbaum', 'Affiliation': 'Neuromuscular Investigation Centre, Institute of Myology, Pitié-Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Friedman', 'Affiliation': 'General Intensive Care Unit, APHP, Raymond Poincaré Hospital, University of Versailles Saint-Quentin en Yvelines, Garches, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Clair', 'Affiliation': 'General Intensive Care Unit, APHP, Raymond Poincaré Hospital, University of Versailles Saint-Quentin en Yvelines, Garches, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA neurology,['10.1001/jamaneurol.2020.5407'] 2144,33284337,Assessment of Financial Toxicity Among Older Adults With Advanced Cancer.,"Importance Financial toxicity (FT), unintended and unanticipated financial burden experienced by cancer patients undergoing cancer care, is associated with negative consequences and increased risk of mortality. Older patients (≥70 years) with cancer are at risk for FT, yet data are limited on FT and whether oncologists discuss FT with their patients. Objective To examine the prevalence of FT in older adults with advanced cancer, its association with health-related quality of life (HRQoL), and cost conversations between oncologists and patients. Design, Setting, and Participants This cross-sectional secondary analysis was performed on baseline data from the Improving Communication in Older Cancer Patients and Their Caregivers study, a cluster randomized trial from 31 community oncology practices across the US that was conducted from October 29, 2014, to April 28, 2017. Participants included 536 patients with advanced cancer who answered 3 questions regarding financial toxicity. Data were analyzed from September 1, 2019, to May 1, 2020. Exposure Older patients undergoing cancer care treatments. Main Outcomes and Measures The main outcome looked at FT and its association with HRQoL. Three questions were used to identify patients 70 years or older experiencing FT. Multivariable linear regression models were used to assess the independent associations of FT with HRQoL. A single audio-recorded clinic transcript was analyzed within 4 weeks of enrollment for patients with FT. The framework method was used to identify frequency and themes related to cost conversations. Results This study evaluated 536 patients 70 years or older with advanced cancer. Ninety-eight patients (18.3%) reported FT; mean (SD) age was 76.4 (5.4) years; 59 (60.2%) were female, 14 (14.3%) were Black/African American, 91 (92.9%) were not employed, and 29 (29.6%) had Medicare as their sole insurance coverage. On multivariate regression analyses, FT was associated with higher levels of depression (β = 0.81; 95% CI, 0.15-1.48), anxiety (β = 1.67; 95% CI, 0.74-2.61), and distress (β = 0.73; 95% CI, 0.08-1.39) and lower HRQoL (β = -5.30; 95% CI, -8.92 to -1.69). Among those who reported FT, 49% had a conversation with their health care professional about costs. Most conversations (79%) were initiated by oncologists or patients. Four themes were generated from cost conversations: statements regarding cost of care, ability to afford medical prescriptions, indirect consequences associated with inability to work and provide for family, and cost burden in nontreatment domains. Conclusions and Relevance In this study, among older adults with advanced cancer, FT is associated with worse HRQoL. Almost half of conversations among patients reporting FT demonstrated costs are being actively discussed. Resources and interventions are needed to manage FT.",2020,"On multivariate regression analyses, FT was associated with higher levels of depression (β = 0.81; 95% CI, 0.15-1.48), anxiety (β = 1.67; 95% CI, 0.74-2.61), and distress (β = 0.73; 95% CI, 0.08-1.39) and lower HRQoL (β = -5.30; 95% CI, -8.92 to -1.69).","['older adults with advanced cancer', 'cancer patients undergoing cancer care', 'Older Adults With Advanced Cancer', 'Ninety-eight patients (18.3%) reported FT; mean (SD) age was 76.4 (5.4) years; 59 (60.2%) were female, 14 (14.3%) were Black/African American, 91 (92.9%) were not employed, and 29 (29.6%) had Medicare as their sole insurance coverage', 'Older Cancer Patients and Their Caregivers study, a cluster randomized trial from 31 community oncology practices across the US that was conducted from October 29, 2014, to April 28, 2017', 'Participants included 536 patients with advanced cancer who answered 3 questions regarding financial toxicity', 'Older patients (≥70 years) with cancer', '536 patients 70 years or older with advanced cancer', 'Older patients undergoing cancer care treatments']",[],"['Financial Toxicity', 'anxiety']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0376629', 'cui_str': 'Insurance Status'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],"[{'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",31.0,0.0542144,"On multivariate regression analyses, FT was associated with higher levels of depression (β = 0.81; 95% CI, 0.15-1.48), anxiety (β = 1.67; 95% CI, 0.74-2.61), and distress (β = 0.73; 95% CI, 0.08-1.39) and lower HRQoL (β = -5.30; 95% CI, -8.92 to -1.69).","[{'ForeName': 'Asad', 'Initials': 'A', 'LastName': 'Arastu', 'Affiliation': 'Department of Medicine, Oregon Health and Science University Hospital, Portland.'}, {'ForeName': 'Arpan', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Division of Hematology/Oncology, James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Supriya Gupta', 'Initials': 'SG', 'LastName': 'Mohile', 'Affiliation': 'Division of Hematology/Oncology, James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Ciminelli', 'Affiliation': 'Department of Biostatistics, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Ramya', 'Initials': 'R', 'LastName': 'Kaushik', 'Affiliation': 'University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Wells', 'Affiliation': 'Division of Hematology/Oncology, James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Culakova', 'Affiliation': 'Department of Surgery, Cancer Control, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Lianlian', 'Initials': 'L', 'LastName': 'Lei', 'Affiliation': 'Department of Public Health Sciences, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Huiwen', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Surgery, Cancer Control, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dougherty', 'Affiliation': 'Dana Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Mostafa R', 'Initials': 'MR', 'LastName': 'Mohamed', 'Affiliation': 'Division of Hematology/Oncology, James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Hill', 'Affiliation': 'Department of Public Health Sciences, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Duberstein', 'Affiliation': 'Department of Health Behavior, Society, and Policy, Rutgers School of Public Health, Piscataway, New Jersey.'}, {'ForeName': 'Marie Anne', 'Initials': 'MA', 'LastName': 'Flannery', 'Affiliation': 'School of Nursing, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Charles Stewart', 'Initials': 'CS', 'LastName': 'Kamen', 'Affiliation': 'Division of Hematology/Oncology, James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Chintan', 'Initials': 'C', 'LastName': 'Pandya', 'Affiliation': 'Dana Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Berenberg', 'Affiliation': 'Hawaii National Cancer Institute Community Oncology Research Program, Honolulu.'}, {'ForeName': 'Valerie G', 'Initials': 'VG', 'LastName': 'Aarne Grossman', 'Affiliation': 'Division of Hematology/Oncology, James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Neurosurgery, University of Rochester, Rochester, New York.'}, {'ForeName': 'Kah Poh', 'Initials': 'KP', 'LastName': 'Loh', 'Affiliation': 'Division of Hematology/Oncology, James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.25810'] 2145,33556230,Atezolizumab and bevacizumab combination compared with sorafenib as the first-line systemic treatment for patients with unresectable hepatocellular carcinoma: A cost-effectiveness analysis in China and the United states.,"BACKGROUND & AIMS In patients with unresectable hepatocellular carcinoma (HCC), the combination of atezolizumab and bevacizumab improved progression-free survival (PFS) and overall survival compared with sorafenib in the IMbrave150 trial. However, whether the price of the combination could be affordable is unknown. The current study assessed the cost-effectiveness of the combination of atezolizumab and bevacizumab as first-line systemic therapy for patients with unresectable HCC from the Chinese and American payers' perspective. METHODS A Markov model was built based on a global, multicentre, open-label, phase III randomized trial (IMbrave150, NCT03434379) that included three states of the patient's health: stable disease (SD), progressive disease (PD) and death. Data for all medical costs were acquired from the Red Book, published literature and West China Hospital. Quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs) were the primary outcomes. Sensitivity analyses were performed to evaluate the model uncertainty. RESULTS The treatment consisting of a combination of atezolizumab and bevacizumab yielded an additional 0.53 QALYs compared with sorafenib alone, leading to an ICER of $145,546.21 per QALY in China and $168,030.21 per QALY in the USA, both beyond the willing-to-pay threshold ($28,527.00/QALY in China and $150,000.00 /QALY in the USA). The utility of the PD state was the most influential factor in the Chinese model, and the American model was the most sensitive to the price of sorafenib. The results of the models were robust across sensitivity analyses. CONCLUSION The combination of atezolizumab and bevacizumab was not a cost-effective strategy for the first-line systemic treatment of unresectable HCC from the Chinese and American payers' perspective.",2021,"The treatment consisting of a combination of atezolizumab and bevacizumab yielded an additional 0.53 QALYs compared with sorafenib alone, leading to an ICER of $145,546.21 per QALY in China and $168,030.21 per QALY in the USA, both beyond the willing-to-pay threshold ($28,527.00/QALY in China and $150,000.00 /QALY in the USA).","[""included three states of the patient's health: stable disease (SD), progressive disease (PD) and death"", 'patients with unresectable hepatocellular carcinoma (HCC', ""patients with unresectable HCC from the Chinese and American payers' perspective"", 'patients with unresectable hepatocellular carcinoma']","['Atezolizumab and bevacizumab combination', 'atezolizumab and bevacizumab', 'sorafenib']","['Quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs', 'progression-free survival (PFS) and overall survival', 'cost-effectiveness']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1112459', 'cui_str': 'Liver cell carcinoma non-resectable'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.0707393,"The treatment consisting of a combination of atezolizumab and bevacizumab yielded an additional 0.53 QALYs compared with sorafenib alone, leading to an ICER of $145,546.21 per QALY in China and $168,030.21 per QALY in the USA, both beyond the willing-to-pay threshold ($28,527.00/QALY in China and $150,000.00 /QALY in the USA).","[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Wen', 'Affiliation': 'Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Hanrui', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'West China Biostatistics and Cost-Benefit Analysis Center, Sichuan University, Chengdu, China.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Weiting', 'Initials': 'W', 'LastName': 'Liao', 'Affiliation': 'Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Kexun', 'Initials': 'K', 'LastName': 'Zhou', 'Affiliation': 'Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Qiu', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.'}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.14795'] 2146,33560350,Early results from the CODEL trial for anaplastic oligodendrogliomas: is temozolomide futile?,,2021,,[],['temozolomide'],[],[],"[{'cui': 'C0076080', 'cui_str': 'temozolomide'}]",[],,0.0323027,,"[{'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Lassman', 'Affiliation': 'Division of Neuro-Oncology, Department of Neurology, Columbia University Vagelos College of Physicians and Surgeons, Herbert Irving Comprehensive Cancer Center, NewYork-Presbyterian Hospital, New York, New York.'}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Cloughesy', 'Affiliation': 'Neuro-Oncology Program and Department of Neurology, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California.'}]",Neuro-oncology,['10.1093/neuonc/noab006'] 2147,33560349,Safety and Pharmacokinetics of Double-Dose Lopinavir/Ritonavir + Rifampin vs. Lopinavir/Ritonavir + Daily Rifabutin for Treatment of HIV-TB Coinfection.,"BACKGROUND Protease inhibitor-based antiretroviral therapy (ART) may be used in resource-limited settings in persons with HIV-TB. Data on safety, pharmacokinetics/pharmacodynamics (PK/PD), and HIV-TB outcomes for lopinavir/ritonavir (LPV/r) used with rifampin (RIF) or rifabutin (RBT) are limited. METHODS We randomized adults with HIV-TB from July 2013 to February 2016 to: Arm A, LPV/r 400mg/100mg twice daily+RBT 150mg/day; Arm B, LPV/r 800mg/200mg twice daily+RIF 600mg/day; or Arm C, LPV/r 400mg/100mg twice daily+raltegravir (RAL) 400mg twice daily+RBT 150mg/day; all received two nucleoside reverse transcriptase inhibitors and other TB drugs. PK visits occurred on day 12+2. Within-arm HIV-TB outcomes were summarized using proportions and 95% confidence intervals; PK was compared using Wilcoxon tests. RESULTS Among 71 participants, 52% were women; 72% Black; 46% Hispanic; median age 37 years; median CD4 + 130 cells/mm 3; median HIV-1 RNA 4.6 log10 copies/mL; 46% had confirmed TB. LPV concentrations were similar across arms. Pooled LPV AUC12 (157,203 h*ng/mL) and Ctrough (9,876 ng/mL) were similar to historical controls; RBT AUC24 (7,374 h*ng/mL) and Ctrough (208 ng/mL) were higher. Grade 3 uveitis due to RBT occurred in three participants; three in Arm C had RBT Cmax <250ng/mL. Proportions with week 48 HIV-1 RNA <400 copies/mL were 58%, 67%, and 61% and week 8 sputum conversion were 88%, 82%, and 70%, respectively, in Arms A, B, and C. CONCLUSIONS Double-dose LPV/r+RIF and LPV/r+RBT 150mg/day had acceptable safety, PK and TB outcomes; viral suppression was suboptimal unrelated to PK. Faster RBT clearance and low Cmax in three participants on RBT+RAL requires further study.",2021,"Grade 3 uveitis due to RBT occurred in three participants; three in Arm C had RBT Cmax <250ng/mL. Proportions with week 48 HIV-1 RNA <400 copies/mL were 58%, 67%, and 61% and week 8 sputum conversion were 88%, 82%, and 70%, respectively, in Arms A, B, and C. CONCLUSIONS Double-dose LPV/r+RIF and LPV/r+RBT 150mg/day had acceptable safety, PK and TB outcomes; viral suppression was suboptimal unrelated to PK.","['72% Black; 46% Hispanic; median age 37 years; median CD4\xa0+\xa0130 cells/mm 3', 'persons with HIV-TB', 'HIV-TB Coinfection', '71 participants, 52% were women']","['LPV/r 400mg/100mg twice daily+RBT 150mg/day; Arm B, LPV/r 800mg/200mg twice daily+RIF', 'Double-Dose Lopinavir/Ritonavir + Rifampin vs. Lopinavir/Ritonavir + Daily Rifabutin', 'LPV/r 400mg/100mg twice daily+raltegravir (RAL', 'lopinavir/ritonavir (LPV/r) used with rifampin (RIF) or rifabutin (RBT', 'Pooled LPV AUC12', 'nucleoside reverse transcriptase inhibitors and other TB drugs', 'Protease inhibitor-based antiretroviral therapy (ART']","['LPV concentrations', 'Grade 3 uveitis due to RBT', 'Safety and Pharmacokinetics', 'Faster RBT clearance and low Cmax', 'PK visits', 'median HIV-1', 'acceptable safety, PK and TB outcomes; viral suppression', 'safety, pharmacokinetics/pharmacodynamics (PK/PD), and HIV-TB outcomes']","[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0275524', 'cui_str': 'Mixed infectious disease'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0140575', 'cui_str': 'Rifabutin'}, {'cui': 'C1871526', 'cui_str': 'raltegravir'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0028621', 'cui_str': 'Nucleoside'}, {'cui': 'C0282519', 'cui_str': 'Reverse transcriptase inhibitor'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0033607', 'cui_str': 'Peptide hydrolase inhibitor'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0140575', 'cui_str': 'Rifabutin'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",52.0,0.515645,"Grade 3 uveitis due to RBT occurred in three participants; three in Arm C had RBT Cmax <250ng/mL. Proportions with week 48 HIV-1 RNA <400 copies/mL were 58%, 67%, and 61% and week 8 sputum conversion were 88%, 82%, and 70%, respectively, in Arms A, B, and C. CONCLUSIONS Double-dose LPV/r+RIF and LPV/r+RBT 150mg/day had acceptable safety, PK and TB outcomes; viral suppression was suboptimal unrelated to PK.","[{'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Kendall', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Umesh', 'Initials': 'U', 'LastName': 'Lalloo', 'Affiliation': 'Enhancing Care Foundation, Durban International Clinical Research Site (CRS), Durban, South Africa.'}, {'ForeName': 'Courtney V', 'Initials': 'CV', 'LastName': 'Fletcher', 'Affiliation': 'UNMC Center for Drug Discovery, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Xingye', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Anthony T', 'Initials': 'AT', 'LastName': 'Podany', 'Affiliation': 'UNMC Center for Drug Discovery, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Sandra W', 'Initials': 'SW', 'LastName': 'Cardoso', 'Affiliation': 'Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS, Rio de Janeiro, Brazil.'}, {'ForeName': 'Prudence', 'Initials': 'P', 'LastName': 'Ive', 'Affiliation': 'Clinical HIV Research Unit, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Constance A', 'Initials': 'CA', 'LastName': 'Benson', 'Affiliation': 'Antiviral Research Center, University of California, San Diego, San Diego, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciab097'] 2148,33560775,A Single Bout of Upper-Body Exercise Has No Effect on Postprandial Metabolism in Persons with Chronic Paraplegia.,"PURPOSE The acute effects of a single bout of upper-body exercise on postprandial metabolism in persons with spinal cord injury are currently not well understood. The primary aim of this study was to evaluate the effects of a single bout of upper-body high-intensity interval exercise (HIIE) and moderate-intensity continuous exercise (MICE) in comparison with a no-exercise control (REST) condition on postprandial metabolic responses in persons with chronic paraplegia. METHODS Ten participants (eight males, two females; age, 49 ± 10 yr; time since injury, 22 ± 13 yr) with chronic paraplegia took part in a randomized crossover study, consisting of three trials: HIIE (8 × 60 s at 70% peak power output [PPEAK]), MICE (25 min at 45% PPEAK), and REST, at least 3 d apart. Exercise was performed in the fasted state, and participants consumed a mixed-macronutrient liquid meal 1-h postexercise. Venous blood and expired gas samples were collected at regular intervals for 6-h postmeal consumption. RESULTS There were no significant differences in postprandial incremental area under the curve for triglycerides (P = 0.59) or glucose (P = 0.56) between conditions. Insulin incremental area under the curve tended to be lower after MICE (135 ± 85 nmol·L-1 per 360 min) compared with REST (162 ± 93 nmol·L-1 per 360 min), but this did not reach statistical significance (P = 0.06, d = 0.30). Participants reported a greater fondness (P = 0.04) and preference for HIIE over MICE. CONCLUSIONS After an overnight fast, a single bout of upper-body exercise before eating has no effect on postprandial metabolism in persons with chronic paraplegia, irrespective of exercise intensity. This suggests that alternative exercise strategies may be required to stimulate postprandial substrate oxidation for this population.",2021,There were no significant differences in postprandial iAUC for triglycerides (p=0.59) or glucose (p=0.56) between conditions.,"['persons with spinal cord injury', 'Persons with Chronic Paraplegia', '10 participants (eight males, two females, age: 49 ± 10 yrs, time since injury: 22 ± 13 yrs) with chronic paraplegia took part in a randomised cross-over study', 'persons with chronic paraplegia']","['single bout of upper-body high-intensity interval exercise (HIIE) and moderate-intensity continuous exercise (MICE', 'Upper-Body Exercise', 'exercise control (REST) condition', 'single bout of upper-body exercise']","['Venous blood and expired gas samples', 'postprandial metabolic responses', 'Postprandial Metabolism', 'Insulin iAUC', 'postprandial metabolism', 'postprandial iAUC for triglycerides']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C3698571', 'cui_str': 'Chronic paraplegia'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449246', 'cui_str': 'Time since injury'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1268087', 'cui_str': 'Upper body structure'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",10.0,0.0948133,There were no significant differences in postprandial iAUC for triglycerides (p=0.59) or glucose (p=0.56) between conditions.,"[{'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Farrow', 'Affiliation': ''}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Maher', 'Affiliation': ''}, {'ForeName': 'Tom E', 'Initials': 'TE', 'LastName': 'Nightingale', 'Affiliation': ''}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': ''}, {'ForeName': 'James L J', 'Initials': 'JLJ', 'LastName': 'Bilzon', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002561'] 2149,33566105,Effect of Personalized Incentives on Dietary Quality of Groceries Purchased: A Randomized Crossover Trial.,"Importance Many factors are associated with food choice. Personalized interventions could help improve dietary intake by using individual purchasing preferences to promote healthier grocery purchases. Objective To test whether a healthy food incentive intervention using an algorithm incorporating customer preferences, purchase history, and baseline diet quality improves grocery purchase dietary quality and spending on healthy foods. Design, Setting, and Participants This was a 9-month randomized clinical crossover trial (AB-BA) with a 2- to 4-week washout period between 3-month intervention periods. Participants included 224 loyalty program members at an independent Rhode Island supermarket who completed baseline questionnaires and were randomized from July to September 2018 to group 1 (AB) or group 2 (BA). Data analysis was performed from September 2019 to May 2020. Intervention Participants received personalized weekly coupons with nutrition education during the intervention period (A) and occasional generic coupons with nutrition education during the control period (B). An automated study algorithm used customer data to allocate personalized healthy food incentives to participant loyalty cards. All participants received a 5% grocery discount. Main Outcomes and Measures Grocery Purchase Quality Index-2016 (GPQI-16) scores (range, 0-75, with higher scores denoting healthier purchases) and percentage spending on targeted foods were calculated from cumulative purchasing data. Participants in the top and bottom 1% of spending were excluded. Paired t tests examined between-group differences. Results The analytical sample included 209 participants (104 in group 1 and 105 in group 2), with a mean (SD) age of 55.4 (14.0) years. They were predominantly non-Hispanic White (193 of 206 participants [94.1%]) and female (187 of 207 participants [90.3%]). Of 161 participants with income data, 81 (50.3%) had annual household incomes greater than or equal to $100 000. Paired t tests showed that the intervention increased GPQI-16 scores (between-group difference, 1.06; 95% CI, 0.27-1.86; P = .01) and percentage spending on targeted foods (between-group difference, 1.38%; 95% CI, 0.08%-2.69%; P = .04). During the initial intervention period, group 1 (AB) and group 2 (BA) had similar mean (SD) GPQI-16 scores (41.2 [6.6] vs 41.0 [7.5]) and mean (SD) percentage spending on targeted healthy foods (32.0% [10.8%] vs 31.0% [10.5%]). During the crossover intervention period, group 2 had a higher mean (SD) GPQI-16 score than group 1 (42.9 [7.7] vs 41.0 [6.8]) and mean (SD) percentage spending on targeted foods (34.0% [12.1%] vs 32.0% [13.1%]). Conclusions and Relevance This pilot trial demonstrated preliminary evidence for the effectiveness of a novel personalized healthy food incentive algorithm to improve grocery purchase dietary quality. Trial Registration ClinicalTrials.gov Identifier: NCT03748056.",2021,"Paired t tests showed that the intervention increased GPQI-16 scores (between-group difference, 1.06; 95% CI, 0.27-1.86; P = .01) and percentage spending on targeted foods (between-group difference, 1.38%; 95% CI, 0.08%-2.69%; P = .04).","['Participants in the top and bottom 1% of spending were excluded', '209 participants (104 in group 1 and 105 in group 2), with a mean (SD) age of 55.4 (14.0) years', 'Groceries Purchased', '161 participants with income data, 81 (50.3%) had annual household incomes greater than or equal to $100\u202f000', 'They were predominantly non-Hispanic White (193 of 206 participants [94.1%]) and female (187 of 207 participants [90.3', 'Participants included 224 loyalty program members at an independent Rhode Island supermarket who completed baseline questionnaires']","['Personalized Incentives', 'novel personalized healthy food incentive algorithm', 'healthy food incentive intervention', 'personalized weekly coupons with nutrition education during the intervention period (A) and occasional generic coupons with nutrition education']","['dietary intake', 'percentage spending on targeted foods', 'GPQI-16 scores', 'higher mean (SD) GPQI-16 score', 'mean (SD) GPQI-16 scores', 'Measures\n\n\nGrocery Purchase Quality Index-2016 (GPQI-16) scores (range, 0-75, with higher\u2009scores denoting\u2009healthier purchases) and percentage spending on targeted foods']","[{'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0557163', 'cui_str': 'Household income'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0035487', 'cui_str': 'Rhode Island'}, {'cui': 'C0557778', 'cui_str': 'Supermarket'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0521114', 'cui_str': 'Infrequent'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}]","[{'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",161.0,0.100386,"Paired t tests showed that the intervention increased GPQI-16 scores (between-group difference, 1.06; 95% CI, 0.27-1.86; P = .01) and percentage spending on targeted foods (between-group difference, 1.38%; 95% CI, 0.08%-2.69%; P = .04).","[{'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Vadiveloo', 'Affiliation': 'Department of Nutrition and Food Sciences, College of Health Sciences, University of Rhode Island, Kingston.'}, {'ForeName': 'Xintong', 'Initials': 'X', 'LastName': 'Guan', 'Affiliation': 'Marketing Area, College of Business Administration, University of Rhode Island, Kingston.'}, {'ForeName': 'Haley W', 'Initials': 'HW', 'LastName': 'Parker', 'Affiliation': 'Department of Nutrition and Food Sciences, College of Health Sciences, University of Rhode Island, Kingston.'}, {'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'Perraud', 'Affiliation': 'AgroParis Tech, Paris, France.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Buchanan', 'Affiliation': 'Department of Pharmacy Practice, College of Pharmacy, University of Rhode Island, Kingston.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Atlas', 'Affiliation': 'Marketing Area, College of Business Administration, University of Rhode Island, Kingston.'}, {'ForeName': 'Anne N', 'Initials': 'AN', 'LastName': 'Thorndike', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.30921'] 2150,33570248,Achieving optimal adherence to medical therapy by telehealth: Findings from the ORBITA medication adherence sub-study.,"INTRODUCTION The ORBITA trial of percutaneous coronary intervention (PCI) versus a placebo procedure for patients with stable angina was conducted across six sites in the United Kingdom via home monitoring and telephone consultations. Patients underwent detailed assessment of medication adherence which allowed us to measure the efficacy of the implementation of the optimization protocol and interpretation of the main trial endpoints. METHODS Prescribing data were collected throughout the trial. Self-reported adherence was assessed, and urine samples collected at pre-randomization and at follow-up for direct assessment of adherence using high-performance liquid chromatography with tandem mass spectrometry (HPLC MS/MS). RESULTS Self-reported adherence was >96% for all drugs in both treatment groups at both stages. The percentage of samples in which drug was detected at pre-randomization and at follow-up in the PCI versus placebo groups respectively was: clopidogrel, 96% versus 90% and 98% versus 94%; atorvastatin, 95% versus 92% and 92% versus 91%; perindopril, 95% versus 97% and 85% versus 100%; bisoprolol, 98% versus 99% and 96% versus 97%; amlodipine, 99% versus 99% and 94% versus 96%; nicorandil, 98% versus 96% and 94% versus 92%; ivabradine, 100% versus 100% and 100% versus 100%; and ranolazine, 100% versus 100% and 100% versus 100%. CONCLUSIONS Adherence levels were high throughout the study when quantified by self-reporting methods and similarly high proportions of drug were detected by urinary assay. The results indicate successful implementation of the optimization protocol delivered by telephone, an approach that could serve as a model for treatment of chronic conditions, particularly as consultations are increasingly conducted online.",2021,Self-reported adherence was >96% for all drugs in both treatment groups at both stages.,['patients with stable angina was conducted across six sites in the United Kingdom via home monitoring and telephone consultations'],"['ranolazine', 'placebo', 'percutaneous coronary intervention (PCI', 'perindopril', 'placebo procedure', 'amlodipine', 'nicorandil', 'atorvastatin']",['Self-reported adherence'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0175745', 'cui_str': 'Telephone consultation'}]","[{'cui': 'C0073633', 'cui_str': 'ranolazine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0136123', 'cui_str': 'Perindopril'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0068700', 'cui_str': 'Nicorandil'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.0320677,Self-reported adherence was >96% for all drugs in both treatment groups at both stages.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Rasha', 'Initials': 'R', 'LastName': 'Al-Lamee', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Foley', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Hakim M', 'Initials': 'HM', 'LastName': 'Dehbi', 'Affiliation': 'Comprehensive Clinical Trials Unit at UCL, University College London, London, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Thom', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Justin E', 'Initials': 'JE', 'LastName': 'Davies', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Darrel P', 'Initials': 'DP', 'LastName': 'Francis', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Prashanth', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Department of Chemical Pathology and Metabolic Diseases, University Hospitals of Leicester, Leicester, UK.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': 'Department of Chemical Pathology and Metabolic Diseases, University Hospitals of Leicester, Leicester, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pharmacology research & perspectives,['10.1002/prp2.710'] 2151,33568510,A Randomized Placebo-Controlled Efficacy Study of a Prime Boost Therapeutic Vaccination Strategy in HIV-1-Infected Individuals: VRI02 ANRS 149 LIGHT Phase II Trial.,"In this placebo-controlled phase II randomized clinical trial, 103 human immunodeficiency virus type 1 (HIV-1)-infected patients under cART (combined antiretroviral treatment) were randomized 2:1 to receive either 3 doses of DNA GTU-MultiHIV B (coding for Rev, Nef, Tat, Gag, and gp160) at week 0 (W0), W4, and W12, followed by 2 doses of LIPO-5 vaccine containing long peptides from Gag, Pol, and Nef at W20 and W24, or placebo. Analytical treatment interruption (ATI) was performed between W36 to W48. At W28, vaccinees experienced an increase in functional CD4 + T-cell responses ( P  < 0.001 for each cytokine compared to W0) measured, predominantly against Gag and Pol/Env, and an increase in HIV-specific CD8 + T cells producing interleukin 2 (IL-2) and tumor necrosis factor alpha (TNF-α) ( P  = 0.001 and 0.013, respectively), predominantly against Pol/Env and Nef. However, analysis of T-cell subsets by mass cytometry in a subpopulation showed an increase in the W28/W0 ratio for memory CD8 + T cells coexpressing exhaustion and senescence markers such as PD-1/TIGIT ( P  = 0.004) and CD27/CD57 ( P  = 0.044) in vaccinees compared to the placebo group. During ATI, all patients experienced viral rebound, with the maximum observed HIV RNA level at W42 (median, 4.63 log 10 copies [cp]/ml; interquartile range [IQR], 4.00 to 5.09), without any difference between arms. No patient resumed cART for CD4 cell count drop. Globally, the vaccine strategy was safe. However, a secondary HIV transmission during ATI was observed. These data show that the prime-boost combination of DNA and LIPO-5 vaccines elicited broad and polyfunctional T cells. The contrast between the quality of immune responses and the lack of potent viral control underscores the need for combined immunomodulatory strategies. (This study has been registered at ClinicalTrials.gov under registration no. NCT01492985.) IMPORTANCE In this placebo-controlled phase II randomized clinical trial, we evaluated the safety and immunogenicity of a therapeutic prime-boost vaccine strategy using a recombinant DNA vaccine (GTU-MultiHIV B clade) followed by a boost vaccination with a lipopeptide vaccine (HIV-LIPO-5) in HIV-infected patients on combined antiretroviral therapy. We show here that this prime-boost strategy is well tolerated, consistently with previous studies in HIV-1-infected individuals and healthy volunteers who received each vaccine component individually. Compared to the placebo group, vaccinees elicited strong and polyfunctional HIV-specific CD4 + and CD8 + T-cell responses. However, these immune responses presented some qualitative defects and were not able to control viremia following antiretroviral treatment interruption, as no difference in HIV viral rebound was observed in the vaccine and placebo groups. Several lessons were learned from these results, pointing out the urgent need to combine vaccine strategies with other immune-based interventions.",2021,"Compared to placebo group, vaccines elicited strong and polyfunctional HIV-specific CD4 + and CD8 + T cell responses.","['103 HIV-1 infected patients under c-ART (combined antiretroviral treatment', 'HIV-1 infected individuals and healthy volunteers', 'HIV-infected patients while on combined antiretroviral therapy', 'HIV-1 infected individuals']","['lipopeptide vaccine (HIV-LIPO-5', 'recombinant DNA vaccine (GTU®-MultiHIV B clade', 'DNA GTU-MultiHIV B (coding for Rev, Nef, Tat, Gag and gp160) at Week (W)0, W4 and W12 followed by 2 doses of LIPO-5 vaccine containing long peptides from Gag, Pol and Nef at W20 and W24 or placebos', 'placebo']","['HIV-specific CD8 + T cells producing IL-2 and TNF-α', 'functional CD4 + T cell responses', 'safety and immunogenicity', 'polyfunctional HIV-specific CD4 + and CD8 + T cell responses', 'W28/W0 ratio for memory CD8 + T cells co-expressing exhaustion and senescence markers such as PD-1/TIGIT', 'HIV viral rebound', 'HIV RNA level']","[{'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0122111', 'cui_str': 'HMGI-C Protein'}, {'cui': 'C0376613', 'cui_str': 'DNA Vaccines'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0017375', 'cui_str': 'TAT gene'}, {'cui': 'C0016927', 'cui_str': 'Gagging'}, {'cui': 'C0062790', 'cui_str': 'gp160(HIV)'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0078435', 'cui_str': 'W 12'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0032356', 'cui_str': 'Poland'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",103.0,0.246695,"Compared to placebo group, vaccines elicited strong and polyfunctional HIV-specific CD4 + and CD8 + T cell responses.","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Lévy', 'Affiliation': 'Vaccine Research Institute-VRI, Hôpital Henri Mondor, Créteil, France yves.levy@aphp.fr.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lacabaratz', 'Affiliation': 'Vaccine Research Institute-VRI, Hôpital Henri Mondor, Créteil, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lhomme', 'Affiliation': 'Vaccine Research Institute-VRI, Hôpital Henri Mondor, Créteil, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wiedemann', 'Affiliation': 'Vaccine Research Institute-VRI, Hôpital Henri Mondor, Créteil, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bauduin', 'Affiliation': 'University of Bordeaux, ISPED, Inserm, Population Health Research Center, Team MORPH3EUS, UMR 1219, CIC-EC 1401, Bordeaux, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Fenwick', 'Affiliation': 'Vaccine Research Institute-VRI, Hôpital Henri Mondor, Créteil, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Foucat', 'Affiliation': 'Vaccine Research Institute-VRI, Hôpital Henri Mondor, Créteil, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Surenaud', 'Affiliation': 'Vaccine Research Institute-VRI, Hôpital Henri Mondor, Créteil, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Guillaumat', 'Affiliation': 'Vaccine Research Institute-VRI, Hôpital Henri Mondor, Créteil, France.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Boilet', 'Affiliation': 'University of Bordeaux, ISPED, Inserm, Population Health Research Center, Team MORPH3EUS, UMR 1219, CIC-EC 1401, Bordeaux, France.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Rieux', 'Affiliation': 'Inserm-ANRS, Vaccine Research Office, Paris, France.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Bouchaud', 'Affiliation': 'Hôpital Avicenne, AP-HP, Université Paris 13, Bobigny, France.'}, {'ForeName': 'P-M', 'Initials': 'PM', 'LastName': 'Girard', 'Affiliation': 'Hôpital Saint Antoine, AP-HP, INSERM UMR S_1136, Paris, France.'}, {'ForeName': 'J-M', 'Initials': 'JM', 'LastName': 'Molina', 'Affiliation': 'Hôpital Saint-Louis, AP-HP, Université Paris Diderot INSERM U941, Paris, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Morlat', 'Affiliation': 'CHU de Bordeaux, Bordeaux, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Hocqueloux', 'Affiliation': ""CHR d'Orléans, La Source, France.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Richert', 'Affiliation': 'Vaccine Research Institute-VRI, Hôpital Henri Mondor, Créteil, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Pantaleo', 'Affiliation': 'Vaccine Research Institute-VRI, Hôpital Henri Mondor, Créteil, France.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Lelièvre', 'Affiliation': 'Vaccine Research Institute-VRI, Hôpital Henri Mondor, Créteil, France.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Thiébaut', 'Affiliation': 'Vaccine Research Institute-VRI, Hôpital Henri Mondor, Créteil, France.'}]",Journal of virology,['10.1128/JVI.02165-20'] 2152,33571652,Does dual plating clavicle fractures increase the risk of refracture after hardware removal? A biomechanical investigation.,"BACKGROUND Dual orthogonal plating of midshaft clavicle fractures is increasingly used for osteosynthesis. The risk of refracture after hardware removal remains unknown. The purpose of this study was to compare the torsional and 3-point bending loads to failure of the clavicle following removal of single-plane, superior 3.5-mm plate fixation vs. dual orthogonal plating 2.7-mm constructs. METHODS This study used 12 pairs of clavicles (N = 24) harvested from cadaveric specimens with a mean age at death of 56.5 years (range, 46-65 years). One clavicle from each pair was randomly assigned to either superior plating (SP, n = 12) or double plating (DP, n = 12). For SP, a superior 3.5-mm plate was used as a template to drill 3 bicortical 2.8-mm holes medial and lateral to the center of the clavicle. For DP, two 2.7-mm plates were used as a template to drill 4 bicortical 2.0-mm holes medial and lateral to the center of the clavicle. Clavicle pairs were randomly and evenly distributed to undergo either 3-point bending (n = 12) or posterior torsional loading (n = 12). Cyclic loading was performed, followed by load-to-failure testing. Stiffness, displacement at failure, load to failure, and failure mode were assessed and compared between SP and DP constructs. RESULTS No significant differences between the SP and DP groups were observed for stiffness (768.2 ± 281.3 N/mm vs. 785.5 ± 315.0 N/mm, P = .872), displacement at failure (8.1 ± 2.8 mm vs. 5.4 ± 1.2 mm, P = .150), and ultimate load at failure (1831.0 ± 229.6 N vs. 1842.0 ± 662.4 N, P = .964) under the condition of 3-point bending. Similarly, no significant differences between the SP and DP groups were observed for torsional stiffness (1.3 ± 0.8 N · m/° vs. 1.1 ± 0.4 N · m/°, P = .844), rotation at failure (17.3° ± 4.4° vs. 14.4° ± 1.2°, P = .205), and ultimate torque at failure (14.8 ± 6.5 N · m vs. 14.7 ± 6.9 N · m, P = .103) under the condition of posterior torsional loading. The most common mode of failure for 3-point bending testing was an oblique fracture (7 of 12 clavicles, 58.3%), with no significant difference between groups (3 of 6 in SP group [50%] vs. 4 of 6 in DP group [66.7%], P > .999). The most common mode of failure with posterior torsional loading was a spiral fracture (10 of 12 clavicles, 83.3%), with no significant difference between groups (4 of 6 in SP group [66.7%] vs. 6 of 6 in DP group [100%], P = .455). CONCLUSION Following clavicle plate removal of either DP or SP, there is no statistically significant difference in the amount of force, under the condition of 3-point bending or torsional loading, required to fracture the diaphyseal clavicle in vitro.",2021,"No significant differences between the SP and DP group were observed for stiffness (768.2±281.3 N/mm vs. 785.5±315.0 N/mm; P=0.872), displacement at failure (8.1±2.8 mm vs. 5.4±1.2 mm; P=0.150) and ultimate load at failure (1831.0±229.6 N vs. 1842.0±662.4 N; P=0.964) at 3-point bending.","['Twelve pairs of clavicles (n=24) harvested from cadaveric specimen with a mean age at death of 56.5 years (range, 46 - 65) were utilized']","['superior plating (SP; n=12) or double plating', 'single plane superior 3.5 mm plate fixation versus dual orthogonal plating 2.7 mm constructs', 'posterior torsional loading']","['torsional stiffness', 'ultimate load at failure', 'rotation at failure', 'oblique fracture', 'ultimate torque at failure', 'displacement at failure', 'Stiffness, displacement at failure, load to failure and failure modes']","[{'cui': 'C0008913', 'cui_str': 'Bone structure of clavicle'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0450425', 'cui_str': 'Torsional'}]","[{'cui': 'C0450425', 'cui_str': 'Torsional'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0332711', 'cui_str': 'Fracture, oblique'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}]",,0.0422256,"No significant differences between the SP and DP group were observed for stiffness (768.2±281.3 N/mm vs. 785.5±315.0 N/mm; P=0.872), displacement at failure (8.1±2.8 mm vs. 5.4±1.2 mm; P=0.150) and ultimate load at failure (1831.0±229.6 N vs. 1842.0±662.4 N; P=0.964) at 3-point bending.","[{'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Ruzbarsky', 'Affiliation': 'Department of Orthopaedic Surgery, Steadman Philippon Research Institute, Vail, CO, USA; Department of Orthopaedic Surgery, The Steadman Clinic, Vail, CO, USA. Electronic address: jruzbarsky@thesteadmanclinic.com.'}, {'ForeName': 'Philip-C', 'Initials': 'PC', 'LastName': 'Nolte', 'Affiliation': 'Department of Orthopaedic Surgery, Steadman Philippon Research Institute, Vail, CO, USA; Clinic for Trauma and Orthopaedic Surgery, BG Trauma Center Ludwigshafen, University of Heidelberg, Ludwigshafen, Germany.'}, {'ForeName': 'Jon W', 'Initials': 'JW', 'LastName': 'Miles', 'Affiliation': 'Department of Orthopaedic Surgery, Steadman Philippon Research Institute, Vail, CO, USA.'}, {'ForeName': 'Kira K', 'Initials': 'KK', 'LastName': 'Tanghe', 'Affiliation': 'Department of Orthopaedic Surgery, Steadman Philippon Research Institute, Vail, CO, USA.'}, {'ForeName': 'Anna-K', 'Initials': 'AK', 'LastName': 'Tross', 'Affiliation': 'Department of Orthopaedic Surgery, Steadman Philippon Research Institute, Vail, CO, USA; Clinic for Orthopedics and Trauma Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Hackett', 'Affiliation': 'Department of Orthopaedic Surgery, Steadman Philippon Research Institute, Vail, CO, USA; Department of Orthopaedic Surgery, The Steadman Clinic, Vail, CO, USA.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2020.12.026'] 2153,33577055,"Effect of omeprazole on symptoms of gastroesophageal reflux disease in children with cystic fibrosis. A randomized, double-blind, placebo-controlled trial.","OBJECTIVE The incidence of gastroesophageal reflux disease (GERD) is higher in patients with cystic fibrosis (CF) than in the general population. While the relationship between GERD and its typical symptom, heartburn, is beyond doubt, its effect on cough or abdominal pain is unclear. In CF patients, in particular, it is often difficult to confirm the causal relationship between GERD and these symptoms. The aim of this trial was to evaluate the effect of omeprazole treatment of GERD on abdominal pain and cough, in children with CF. PATIENTS AND METHODS This was a multicentre, randomized, double-blind, placebo-controlled trial. All children aged 4-18 years underwent 24-hour multichannel intraluminal pH-impedance monitoring. The patients with diagnosed GERD were randomly assigned to receive omeprazole (20 mg twice daily for 12 weeks) or placebo. The severity of symptoms was assessed on visual analog scale. RESULTS 22 consecutive patients (median age 11.02± 3,67, range 6.4-17.0) were enrolled. A statistically significant reduction in abdominal pain and typical GERD symptoms, but not cough, was observed in both omeprazole (N=12) and placebo (N=10) groups. However, there were no statistically significant differences between the groups in the degree of reduction. We did not observe any differences between the groups in terms of adverse reactions. CONCLUSIONS Treatment of GERD in children with CF seems not to have a stronger effect than a placebo on the severity of cough and abdominal pain. Considering this, as well as the previously raised concerns about the impact of chronic proton pump inhibitor treatment on the course of CF, perhaps one should be more careful in intensively treating suspected atypical GERD symptoms in patients with CF.",2021,"A statistically significant reduction in abdominal pain and typical GERD symptoms, but not cough, was observed in both omeprazole (N=12) and placebo (N=10) groups.","['22 consecutive patients (median age 11.02± 3,67, range 6.4-17.0) were enrolled', 'patients with diagnosed GERD', 'patients with CF', 'All children aged 4-18 years underwent', 'patients with cystic fibrosis (CF) than in the general population', 'children with CF', 'children with cystic fibrosis']","['24-hour multichannel intraluminal pH-impedance monitoring', 'GERD', 'placebo', 'omeprazole']","['abdominal pain and cough', 'abdominal pain and typical GERD symptoms', 'gastroesophageal reflux disease (GERD', 'visual analog scale', 'severity of cough and abdominal pain', 'gastroesophageal reflux disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0442115', 'cui_str': 'Intraluminal'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}]","[{'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",22.0,0.347657,"A statistically significant reduction in abdominal pain and typical GERD symptoms, but not cough, was observed in both omeprazole (N=12) and placebo (N=10) groups.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dziekiewicz', 'Affiliation': 'Department of Pediatric Gastroenterology and Nutrition, Medical University of Warsaw, Warsaw, Poland. marcin.dziekiewicz@wum.edu.pl.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mielus', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lisowska', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Walkowiak', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Sands', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Radzikowski', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Banaszkiewicz', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_202101_24669'] 2154,33577011,"Changes of anti-β2 glycoprotein I antibody IgA/G/M, platelet aggregation rate, plasma fibrinogen and d-dimer in guiding venous thrombosis during pregnancy.","OBJECTIVE This study provides a theoretical basis for the prevention, treatment and diagnosis of venous thrombosis during pregnancy. PATIENTS AND METHODS Sixty patients with venous thrombosis in gestation period were treated as the research group, including every 30 people in the middle and late pregnancy groups, and the control group randomly selected 33 healthy pregnant women during the same period. The anti-β2 glycoprotein I antibody IgA/G/M, platelet aggregation rate, plasma fibrinogen, and D-dimer levels were measured in all subjects. RESULTS Resistance-β2 glycoprotein I antibody IgA/G/M, platelet aggregation rate, plasma fibrinogen, and compared with the control group, D-dimer levels were significantly increased (p<0.05), but for the middle pregnancy group and late pregnancy group, the difference was not statistically significant (p>0.05). In the control group of pregnant women anti-β2 glycoprotein Ⅰ antibody IgA/G/M, platelet aggregation rate, plasma fibrinogen, and D-dimer no obvious correlation (p>0.05), Anti-β2 glycoprotein Ⅰ antibody IgA/G/M, platelet aggregation rate, plasma fibrinogen, D-dimer entry equation are closely related risk factors for venous thrombosis during pregnancy (p<0.05), and D-dimer is the most important. CONCLUSIONS Vein thrombosis during pregnancy patients anti-β2 glycoprotein I antibody IgA/G/M, platelet aggregation rate, plasma fibrinogen, and D-dimer in pregnant women group increased significantly compared with the control group, suggesting these above indicators are closely related to Venous thrombosis in pregnant women and associated with the severity of the disease. Vascular endothelial injury plays an important role in phlebothrombosis in gestation period.",2021,"The anti-β2 glycoprotein I antibody IgA/G/M, platelet aggregation rate, plasma fibrinogen, and D-dimer levels were measured in all subjects. ","['pregnancy patients', 'Sixty patients with venous thrombosis in gestation period were treated as the research group, including every 30 people in the middle and late pregnancy groups, and the control group randomly selected 33 healthy pregnant women during the same period']",['anti-β2 glycoprotein'],"['anti-β2 glycoprotein I antibody IgA/G/M, platelet aggregation rate, plasma fibrinogen, and D-dimer levels', 'anti-β2 glycoprotein I antibody IgA/G/M, platelet aggregation rate, plasma fibrinogen and d-dimer', 'Vein thrombosis', 'D-dimer levels', 'pregnant women anti-β2 glycoprotein Ⅰ antibody IgA/G/M, platelet aggregation rate, plasma fibrinogen, and D-dimer no obvious correlation (p>0.05), Anti-β2 glycoprotein Ⅰ antibody IgA/G/M, platelet aggregation rate, plasma fibrinogen, D-dimer entry equation', 'platelet aggregation rate, plasma fibrinogen, and D-dimer', 'Resistance-β2 glycoprotein I antibody IgA/G/M, platelet aggregation rate, plasma fibrinogen']","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}, {'cui': 'C0460089', 'cui_str': 'Finding of length of gestation'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0017968', 'cui_str': 'Glycoprotein'}]","[{'cui': 'C0017968', 'cui_str': 'Glycoprotein'}, {'cui': 'C0221138', 'cui_str': 'Blood group antibody I'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0032176', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0856510', 'cui_str': 'Plasma fibrinogen'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",33.0,0.0279337,"The anti-β2 glycoprotein I antibody IgA/G/M, platelet aggregation rate, plasma fibrinogen, and D-dimer levels were measured in all subjects. ","[{'ForeName': 'X', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Operation Room, The Fifth Hospital of Wuhan, Wuhan, Hubei, China. whdwyykjk@163.com.'}, {'ForeName': 'H-P', 'Initials': 'HP', 'LastName': 'Tao', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'F-R', 'Initials': 'FR', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Q-Y', 'Initials': 'QY', 'LastName': 'Pan', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_202101_24616'] 2155,33575950,"Pharmacokinetics and Pharmacodynamics of Esomeprazole/Sodium Bicarbonate Immediate-Release Capsules in Healthy Chinese Volunteers: A Cross-Over, Randomized Controlled Trial.","INTRODUCTION Esomeprazole delayed release tablets (ESO) are one of the most effective treatments for acid-related disorders. The purpose of this study is to compare the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of an immediate-release capsule formulation containing esomeprazole 20 mg and sodium bicarbonate 1100 mg (IR-ESO) compared to those of the esomeprazole delayed release tablet 20 mg (ESO). In addition, the impact of CYP2C19 gene polymorphisms on PK and PD was evaluated. METHODS A single-center, open-label, randomized, 2-treatment, 2-sequence, and 2-period crossover study was conducted in 40 healthy Chinese subjects. Subjects received either IR-ESO or ESO for 5 days. After single- and multiple-dosing administration, blood samples were collected for PK analysis, and intragastric pH was assessed by 24-h pH monitoring. The CYP2C19 gene polymorphisms were analyzed by Sanger sequencing. RESULTS The geometric mean ratios (90% confidence interval) [GMR (95%CI)] of IR-ESO/ESO for AUC inf [single dose: 103.60% (96.58%, 111.14%), multiple doses: 101.65% (97.88%, 105.57%)] were within the range of 80.00-125.00%. The AUC inf showed an increasing trend between CYP2C19 extensive metabolizer (EM), intermediate metabolizer (IM), and poor metabolizer (PM) after single-dose and multiple-dose administration (p < 0.05). The GMR (95%CI) of IR-ESO/ESO for 24-h integrated gastric acidity from baseline [single dose: 101.07% (96.56%, 105.78%), multiple doses: 101.24% (97.74%, 104.86%)] were within the range of 80.00-125.00%. The percentage changes in 24-h integrated gastric acidity from baseline was significant difference between EM, IM, and PM after single-dose IR-ESO and ESO (p < 0.05). Drugs were all well tolerated, and there were no significant differences in adverse events between IR-ESO and ESO. CONCLUSION This study showed that IR-ESO can inhibit the secretion of gastric acid rapidly and continuously, and that the PK and PD of IR-ESO are affected by CYP2C19 genotypes. The GMR (95% CI) of IR-ESO/ESO for AUC inf and the percentage changes in 24-h integrated gastric acidity from baseline were all within the range of 80.00-125.00%. TRIAL REGISTRATION Chinese Clinical Trial Registry: ChiCTR1900024935.",2021,"Drugs were all well tolerated, and there were no significant differences in adverse events between IR-ESO and ESO. ","['40 healthy Chinese subjects', 'Healthy Chinese Volunteers']","['Esomeprazole delayed release tablets (ESO', 'IR-ESO', 'Esomeprazole/Sodium Bicarbonate Immediate-Release Capsules', 'esomeprazole', 'esomeprazole 20\xa0mg and sodium bicarbonate 1100\xa0mg (IR-ESO', 'IR-ESO or ESO']","['safety, pharmacokinetics (PK) and pharmacodynamics (PD', 'GMR (95%CI) of IR-ESO/ESO for 24-h integrated gastric acidity', '24-h integrated gastric acidity', 'adverse events', 'geometric mean ratios', 'CYP2C19 extensive metabolizer (EM), intermediate metabolizer (IM), and poor metabolizer (PM']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C1146111', 'cui_str': 'Esomeprazole 20 MG'}, {'cui': 'C1702614', 'cui_str': 'Sodium Bicarbonate 1100 MG'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1522544', 'cui_str': 'CSF2RA protein, human'}, {'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0017120', 'cui_str': 'Gastric acidity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]",40.0,0.0408513,"Drugs were all well tolerated, and there were no significant differences in adverse events between IR-ESO and ESO. ","[{'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Jing', 'Affiliation': 'Clinical Pharmacology Centre, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Changchun Haiyue Pharmaceutical Co., Ltd., Changchun, China.'}, {'ForeName': 'Wenfang', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Clinical Pharmacology Centre, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Kexu', 'Initials': 'K', 'LastName': 'Yang', 'Affiliation': 'Clinical Pharmacology Centre, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': 'Changchun Haiyue Pharmaceutical Co., Ltd., Changchun, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Deng', 'Affiliation': 'Changchun Haiyue Pharmaceutical Co., Ltd., Changchun, China.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': 'Clinical Pharmacology Centre, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Clinical Pharmacology Centre, Beijing Anzhen Hospital, Capital Medical University, Beijing, China. icp@anzhengcp.com.'}]",Advances in therapy,['10.1007/s12325-021-01644-7'] 2156,33594912,Appropriateness of Replacing Fluoroscopic Guidance With ECG-Electromagnetic Guidance for PICC Insertion: A Randomized Controlled Trial.,"OBJECTIVE. Coupled ECG-electromagnetic (EM) guidance shows promise for use in placement of peripherally inserted central catheters (PICCs) when compared with the classic blind technique. However, ECG-EM guidance has not been appropriately compared with the reference standard of fluoroscopy (FX) guidance. Here, we aimed to compare ECG-EM guidance with FX guidance with regard to the final tip position of PICCs. SUBJECTS AND METHODS. A total of 120 patients (age range, 19-94 years) referred for PICC placement were randomized to the ECG-EM or FX group. All interventions were performed by PICC team members who had the same standardized training and experience. Final tip position was assessed using chest radiography and was classified as optimal, suboptimal, or inadequate requiring repositioning on the basis of the distance from the PICC tip to the cavoatrial junction (CAJ). Statistical analyses were performed using the Mann-Whitney U test for final catheter tip position (mean distance from CAJ) and Fisher and chi-square tests for proportions. RESULTS. PICCs were successfully inserted in 118 patients (53 men and 65 women). Catheter tip positions were optimal or suboptimal in 100% of the FX group and 77.2% of the ECG-EM group. Furthermore, precision of placement was significantly better ( p = .004) in the FX group (mean distance from the PICC tip to the CAJ = 0.83 cm) than in the ECGEM group (mean distance from the PICC tip to the CAJ = 1.37 cm). Thirteen (22.8%) of the PICCs placed using ECG-EM guidance, all of which were inserted from the left side, were qualified as inadequate requiring repositioning and required another intervention. CONCLUSION. Our results revealed significant differences in final tip position between the ECG-EM and FX guidance techniques and indicate that ECG-EM guidance cannot appropriately replace FX guidance among unselected patients. However, ECGEM guidance could be considered as an acceptable technique for patients in whom the PICC could be inserted from the right side. TRIAL REGISTRATION. ClinicalTrials.gov NCT03652727.",2021,"Furthermore, precision of placement was significantly better ( p = .004) in the FX group (mean distance from the PICC tip to the CAJ = 0.83 cm) than in the ECGEM group (mean distance from the PICC tip to the CAJ = 1.37 cm).","['120 patients (age range, 19-94 years) referred for PICC placement', '118 patients (53 men and 65 women', 'PICC Insertion']","['Replacing Fluoroscopic Guidance With ECG-Electromagnetic Guidance', 'Coupled ECG-electromagnetic (EM) guidance', 'ECG-EM or FX', 'ECGEM']","['precision of placement', 'final tip position']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C2049629', 'cui_str': 'PICC Line Catheterization'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0560563', 'cui_str': 'Fluoroscopic guidance'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0013838', 'cui_str': 'Electromagnetics'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0733755', 'cui_str': 'Position'}]",120.0,0.039347,"Furthermore, precision of placement was significantly better ( p = .004) in the FX group (mean distance from the PICC tip to the CAJ = 0.83 cm) than in the ECGEM group (mean distance from the PICC tip to the CAJ = 1.37 cm).","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Gullo', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Cardiothoracic and Vascular Unit, Lausanne University Hospital, Rue du Bugnon 46, 1011 Lausanne, Switzerland.'}, {'ForeName': 'Anaïs', 'Initials': 'A', 'LastName': 'Colin', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Cardiothoracic and Vascular Unit, Lausanne University Hospital, Rue du Bugnon 46, 1011 Lausanne, Switzerland.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Frossard', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Cardiothoracic and Vascular Unit, Lausanne University Hospital, Rue du Bugnon 46, 1011 Lausanne, Switzerland.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Jouannic', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Cardiothoracic and Vascular Unit, Lausanne University Hospital, Rue du Bugnon 46, 1011 Lausanne, Switzerland.'}, {'ForeName': 'Jean François', 'Initials': 'JF', 'LastName': 'Knebel', 'Affiliation': 'EEG Brain Mapping Core, Center for Biomedical Imaging, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Salah Dine', 'Initials': 'SD', 'LastName': 'Qanadli', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Cardiothoracic and Vascular Unit, Lausanne University Hospital, Rue du Bugnon 46, 1011 Lausanne, Switzerland.'}]",AJR. American journal of roentgenology,['10.2214/AJR.20.23345'] 2157,33600284,Acute cardiovascular responses to a single bout of high intensity inspiratory muscle strength training in healthy young adults.,"High intensity, low volume inspiratory muscle strength training (IMST) has favorable effects on casual systolic blood pressure and systemic vascular resistance. However, the acute effects of IMST on heart rate (HR), blood pressure (BP), and sympathetic regulation of vascular resistance and the trajectory of post exercise recovery are not known. We recruited 14 young adults (7 women/7 men, age: 22 ± 2 years) to perform a single bout of high intensity IMST (inspiratory resistance set at 75% of maximal inspiratory pressure) importantly, female and male subjects were matched in regard to the target inspiratory pressure and target inspiratory muscle work per breath. We recorded HR, beat-to-beat changes in BP and postganglionic, muscle sympathetic nerve activities (MSNA) continuously throughout baseline, a single bout of IMST (comprising five sets of 6 inspiratory efforts) and in recovery. We show that one bout of IMST does not effect a change in BP, however, it effects a significant increase in HR (68.4 ± 11.7 beats/min versus 85.4 ± 13.6 beats/min; P < 0.001) and a significant decline in MSNA (6.8 ± 1.1 bursts/15 s bin; P < 0.001 versus 3.6 ± 0.6 bursts/15 s bin) relative to baseline. Remarkably, among men MSNA rebounded to baseline levels within the first minute of recovery, however, in women, MSNA suppression persisted for 5 min. We show that in healthy young adults, high intensity, low volume respiratory training results in the acute suppression of MSNA. Importantly, MSNA suppression is of greater magnitude and longer duration in women than in men. NEW & NOTEWORTHY Previous studies show 6 weeks of high intensity, low volume inspiratory muscle strength training (IMST) lowers blood pressure (BP) and systemic vascular resistance in young adults. However, the acute response to IMST is unknown. We characterized BP, heart rate, and sympathetic nervous activity (SNA) in healthy young adults at baseline, during IMST, and in recovery. There was no acute effect of IMST on BP, however, there was significant IMST-related suppression of SNA that was of greater magnitude in women than men.",2021,"Remarkably, among men MSNA rebounded to Baseline levels within the first minute of Recovery however in women, MSNA suppression persisted for 5 minutes.","['healthy young adults', 'fourteen young adults (7 women/7 men, age: 22±2 years) to perform a single bout of high intensity IMST (inspiratory resistance set at 75% of maximal inspiratory pressure) importantly, female and male subjects']","['High intensity, low volume inspiratory muscle strength training (IMST', 'single bout of high intensity inspiratory muscle strength training', 'IMST']","['HR', 'MSNA', 'casual systolic blood pressure and systemic vascular resistance', 'HR, beat-to-beat changes in BP and postganglionic, muscle sympathetic nerve activities (MSNA', 'heart rate (HR), blood pressure (BP) and sympathetic regulation of vascular resistance and the trajectory of post exercise recovery']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0042380', 'cui_str': 'Vascular resistance, function'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}]",14.0,0.0941367,"Remarkably, among men MSNA rebounded to Baseline levels within the first minute of Recovery however in women, MSNA suppression persisted for 5 minutes.","[{'ForeName': 'Claire M', 'Initials': 'CM', 'LastName': 'DeLucia', 'Affiliation': 'Department of Physiology University of Arizona College of Medicine, Tucson, Arizona.'}, {'ForeName': 'Dean R', 'Initials': 'DR', 'LastName': 'DeBonis', 'Affiliation': 'Department of Physiology University of Arizona College of Medicine, Tucson, Arizona.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Schwyhart', 'Affiliation': 'Department of Physiology University of Arizona College of Medicine, Tucson, Arizona.'}, {'ForeName': 'E Fiona', 'Initials': 'EF', 'LastName': 'Bailey', 'Affiliation': 'Department of Physiology University of Arizona College of Medicine, Tucson, Arizona.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.01015.2020'] 2158,33559157,Early life stress sensitizes youth to the influence of stress-induced cortisol on memory for affective words.,"Early life stress (ELS) is a well-established risk factor for psychopathology across the lifespan. Cognitive vulnerability to stress-induced cortisol may explain risk and resilience. The current study aimed to elucidate a psychobiological pathway linking stress to altered memory for affective words among youth with and without exposure to ELS. One hundred and fifteen youth (ages 9-16, 47% female) were randomized either to a psychosocial stressor or a control condition. Immediately following the stress or control condition, participants completed a memory task for affective words. Change in salivary cortisol from immediately before to 25 min after stress onset were used to predict memory for affective words. Exposure to the acute laboratory stressor led to activation of the HPA axis. Greater cortisol reactivity was associated with less accurate recognition of negative valence words. Among youth exposed to ELS, greater cortisol reactivity to acute stress was associated with poorer recognition of dysphoric and neutral words. Acute increases in cortisol may interfere with negatively-valenced information processing that has implications for memory. Youth exposed to high ELS may be particularly vulnerable to the effects of cortisol, which may explain one pathway through which stress leads to psychopathology among at-risk youth.",2021,"Among youth exposed to ELS, greater cortisol reactivity to acute stress was associated with poorer recognition of dysphoric and neutral words.","['One hundred and fifteen youth (ages 9-16, 47% female', 'youth with and without exposure to ELS']",['psychosocial stressor or a control condition'],"['cortisol reactivity', 'Change in salivary cortisol', 'Greater cortisol reactivity']","[{'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0205393', 'cui_str': 'Most'}]",,0.0127031,"Among youth exposed to ELS, greater cortisol reactivity to acute stress was associated with poorer recognition of dysphoric and neutral words.","[{'ForeName': 'Kate R', 'Initials': 'KR', 'LastName': 'Kuhlman', 'Affiliation': 'Department of Psychological Science, School of Social Ecology, University of California Irvine, Irvine, CA, USA.'}, {'ForeName': 'Stefanie E', 'Initials': 'SE', 'LastName': 'Mayer', 'Affiliation': 'Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Vargas', 'Affiliation': 'Department of Psychological Science, University of Arkansas, Fayetteville, AR, USA.'}, {'ForeName': 'Nestor L', 'Initials': 'NL', 'LastName': 'Lopez-Duran', 'Affiliation': 'Department of Psychology, University of Michigan, Ann Arbor, MI, USA.'}]",Developmental psychobiology,['10.1002/dev.22105'] 2159,33560426,Effect of Clinical Decision Support on Diagnostic Imaging for Pediatric Appendicitis: A Cluster Randomized Trial.,"Importance Appendicitis is the most common pediatric surgical emergency. Efforts to improve efficiency and quality of care have increased reliance on computed tomography (CT) and ultrasonography (US) in children with suspected appendicitis. Objective To evaluate the effectiveness of an electronic health record-linked clinical decision support intervention, AppyCDS, on diagnostic imaging, health care costs, and safety outcomes for patients with suspected appendicitis. Design, Setting, and Participants In this parallel, cluster randomized trial, 17 community-based general emergency departments (EDs) in California, Minnesota, and Wisconsin were randomized to the AppyCDS intervention group or usual care (UC) group. Patients were aged 5 to 20 years, presenting for an ED visit with right-sided or diffuse abdominal pain lasting 5 days or less. We excluded pregnant patients, those with a prior appendectomy, those with selected comorbidities, and those with traumatic injuries. The trial was conducted from October 2016 to July 2019. Interventions AppyCDS prompted data entry at the point of care to estimate appendicitis risk using the pediatric appendicitis risk calculator (pARC). Based on pARC estimates, AppyCDS recommended next steps in care. Main Outcomes and Measures Primary outcomes were CT, US, or any imaging (CT or US) during the index ED visit. Safety outcomes were perforations, negative appendectomies, and missed appendicitis. Costs were a secondary outcome. Ratio of ratios (RORs) for primary and safety outcomes and differences by group in cost were used to evaluate effectiveness of the clinical decision support tool. Results We enrolled 3161 patients at intervention EDs and 2779 patients at UC EDs. The mean age of patients was 11.9 (4.6) years and 2614 (44.0%) were boys or young men. RORs for CT (0.94; 95% CI, 0.75-1.19), US (0.98; 95% CI, 0.84-1.14), and any imaging (0.96; 95% CI, 0.86-1.07) did not differ by study group. In an exploratory analysis conducted in 1 health system, AppyCDS was associated with a reduction in any imaging (ROR, 0.82; 95% CI, 0.73- 0.93) for patients with pARC score of 15% or less and a reduction in CT (ROR, 0.58; 95% CI, 0.45-0.74) for patients with a pARC score of 16% to 50%. Perforations, negative appendectomies, and cases of missed appendicitis by study phase did not differ significantly by study group. Costs did not differ overall by study group. Conclusions and Relevance In this study, AppyCDS was not associated with overall reductions in diagnostic imaging; exploratory analysis revealed more appropriate use of imaging in patients with a low pARC score. Trial Registration ClinicalTrials.gov Identifier: NCT02633735.",2021,"Perforations, negative appendectomies, and cases of missed appendicitis by study phase did not differ significantly by study group.","['17 community-based general emergency departments (EDs) in California, Minnesota, and Wisconsin', 'Pediatric Appendicitis', 'patients with suspected appendicitis', 'children with suspected appendicitis', 'October 2016 to July 2019', 'Patients were aged 5 to 20 years, presenting for an ED visit with right-sided or diffuse abdominal pain lasting 5 days or less', 'patients with a low pARC score', 'pregnant patients, those with a prior appendectomy, those with selected comorbidities, and those with traumatic injuries', 'The mean age of patients was 11.9 (4.6) years and 2614 (44.0%) were boys or young men', '3161 patients at intervention EDs and 2779 patients at UC EDs']","['AppyCDS intervention group or usual care (UC', 'computed tomography (CT) and ultrasonography (US', 'AppyCDS', 'Clinical Decision Support', 'electronic health record-linked clinical decision support intervention, AppyCDS']","['Ratio of ratios (RORs', 'Costs', 'diagnostic imaging, health care costs, and safety outcomes', 'CT, US, or any imaging (CT or US', 'Perforations, negative appendectomies, and cases of missed appendicitis', 'perforations, negative appendectomies, and missed appendicitis']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0870240', 'cui_str': 'Calculator'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C4042765', 'cui_str': 'Decision Support, Clinical'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}]",3161.0,0.133618,"Perforations, negative appendectomies, and cases of missed appendicitis by study phase did not differ significantly by study group.","[{'ForeName': 'Anupam B', 'Initials': 'AB', 'LastName': 'Kharbanda', 'Affiliation': ""Department of Pediatric Emergency Medicine, Children's Minnesota, Minneapolis.""}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Vazquez-Benitez', 'Affiliation': 'Division of Research, HealthPartners Institute, Minneapolis, Minnesota.'}, {'ForeName': 'Dustin W', 'Initials': 'DW', 'LastName': 'Ballard', 'Affiliation': 'The Permanente Medical Group, Oakland, California.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Vinson', 'Affiliation': 'The Permanente Medical Group, Oakland, California.'}, {'ForeName': 'Uli K', 'Initials': 'UK', 'LastName': 'Chettipally', 'Affiliation': 'The Permanente Medical Group, Oakland, California.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Dehmer', 'Affiliation': 'Division of Research, HealthPartners Institute, Minneapolis, Minnesota.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Ekstrom', 'Affiliation': 'Division of Research, HealthPartners Institute, Minneapolis, Minnesota.'}, {'ForeName': 'Adina S', 'Initials': 'AS', 'LastName': 'Rauchwerger', 'Affiliation': 'The Kaiser Permanente Northern California Division of Research, Oakland, California.'}, {'ForeName': 'Brianna', 'Initials': 'B', 'LastName': 'McMichael', 'Affiliation': ""Department of Pediatric Emergency Medicine, Children's Minnesota, Minneapolis.""}, {'ForeName': 'Dale M', 'Initials': 'DM', 'LastName': 'Cotton', 'Affiliation': 'The Permanente Medical Group, Oakland, California.'}, {'ForeName': 'Mamata V', 'Initials': 'MV', 'LastName': 'Kene', 'Affiliation': 'The Permanente Medical Group, Oakland, California.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Simon', 'Affiliation': 'The Kaiser Permanente Northern California Division of Research, Oakland, California.'}, {'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Division of Research, HealthPartners Institute, Minneapolis, Minnesota.'}, {'ForeName': 'E Margaret', 'Initials': 'EM', 'LastName': 'Warton', 'Affiliation': 'The Kaiser Permanente Northern California Division of Research, Oakland, California.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': ""O'Connor"", 'Affiliation': 'Division of Research, HealthPartners Institute, Minneapolis, Minnesota.'}, {'ForeName': 'Elyse O', 'Initials': 'EO', 'LastName': 'Kharbanda', 'Affiliation': 'Division of Research, HealthPartners Institute, Minneapolis, Minnesota.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA network open,['10.1001/jamanetworkopen.2020.36344'] 2160,33564828,"Soy protein supplementation in men following radical prostatectomy: a 2-year randomized, placebo-controlled clinical trial.","BACKGROUND Many studies have addressed effects of dietary supplementation with soy protein, but most have been inconsistent and few have been long-term studies in men. OBJECTIVES This study was a secondary analysis of body weight, blood pressure, thyroid hormones, iron status, and clinical chemistry in a 2-y trial of soy protein supplementation in middle-aged to older men. METHODS Data were analyzed as secondary outcomes of a randomized controlled trial of dietary supplementation with 20 g/d soy protein isolate, providing 41 mg/d total isoflavones and 23 mg/d genistein, in 44- to 75-y-old men who were at risk of cancer recurrence following prostatectomy randomized to soy (n = 50) or a casein-based placebo (n  = 43). Weight, blood pressure, and blood samples were collected at baseline, every 2 mo in year 1, and every 3 mo in year 2. RESULTS Compared with casein, soy supplementation did not affect body weight, blood pressure, serum total cholesterol, calcium, phosphorus, and thyroid hormones. Serum ferritin concentrations doubled over 2 y in both groups (117-129%), whereas hemoglobin and hematocrit increased slightly. In an exploratory subgroup analysis of soy group data, weight increased in subjects producing equol but not in nonproducers. Blood pressure was reduced in nonequol producers but not in producers. Other endpoints were not affected by equol production status. CONCLUSIONS Soy protein supplementation for 2 y compared with a casein-based placebo did not affect body weight, blood pressure, serum total cholesterol, iron status parameters, calcium, phosphorus, and thyroid hormones. Exploratory analysis suggests that equol production status of subjects on soy may modify effects of soy on body weight and possibly blood pressure. This trial was registered at clinicaltrials.gov as NCT00765479.",2021,"Serum ferritin concentrations doubled over 2 y in both groups (117-129%), whereas hemoglobin and hematocrit increased slightly.","['men following radical prostatectomy', 'middle-aged to older men', '44- to 75-y-old men who were at risk of cancer recurrence following prostatectomy randomized to soy (n\xa0=\xa050) or a']","['placebo', 'casein, soy supplementation', 'Soy protein supplementation', 'dietary supplementation with 20 g/d soy protein isolate, providing 41 mg/d total isoflavones and 23 mg/d genistein', 'casein-based placebo', 'soy protein supplementation']","['body weight, blood pressure, thyroid hormones, iron status, and clinical chemistry', 'body weight, blood pressure, serum total cholesterol, iron status parameters, calcium, phosphorus, and thyroid hormones', 'Serum ferritin concentrations', 'hemoglobin and hematocrit', 'Blood pressure', 'Weight, blood pressure, and blood samples', 'body weight, blood pressure, serum total cholesterol, calcium, phosphorus, and thyroid hormones', 'body weight and possibly blood pressure']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0026062', 'cui_str': 'Middle-age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0074926', 'cui_str': 'Soy Proteins'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0450403', 'cui_str': '20G'}, {'cui': 'C0677666', 'cui_str': 'soy protein isolate'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022179', 'cui_str': 'Isoflavone Derivatives'}, {'cui': 'C0061202', 'cui_str': 'Genistein'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0008000', 'cui_str': 'Clinical Chemistry'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C2362652', 'cui_str': 'Possible diagnosis'}]",,0.285205,"Serum ferritin concentrations doubled over 2 y in both groups (117-129%), whereas hemoglobin and hematocrit increased slightly.","[{'ForeName': 'Maarten C', 'Initials': 'MC', 'LastName': 'Bosland', 'Affiliation': 'Department of Pathology, College of Medicine, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Enk', 'Affiliation': 'Department of Pathology, College of Medicine, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Schmoll', 'Affiliation': 'Department of Environmental Medicine, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Schlicht', 'Affiliation': 'Department of Pathology, College of Medicine, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Randolph', 'Affiliation': 'Department of Environmental Medicine, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Deaton', 'Affiliation': 'Department of Pathology, College of Medicine, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Zeleniuch-Jacquotte', 'Affiliation': 'Department of Environmental Medicine, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Ikuko', 'Initials': 'I', 'LastName': 'Kato', 'Affiliation': 'Department of Environmental Medicine, New York University School of Medicine, New York, NY, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa390'] 2161,33564825,"Impact of nutritional interventions among lactating mothers on the growth of their infants in the first 6 months of life: a randomized controlled trial in Delhi, India.","BACKGROUND In lower-middle-income settings, growth faltering in the first 6 mo of life occurs despite exclusive breastfeeding. OBJECTIVE The aim was to test the efficacy of an approach to improve the dietary adequacy of mothers during lactation and thus improve the growth of their infants. METHODS Eligible mother-infant dyads (infants ≤7 d of age) were randomly assigned to either intervention or control groups. Mothers in the intervention group received snacks that were to be consumed daily, which provided 600 kcal of energy-with 25-30% of energy derived from fats (150-180 kcal) and 13% of energy from protein (80 kcal). Micronutrients were supplemented as daily tablets. We provided counseling on breastfeeding and infant-care practices to mothers in both groups. The primary outcome was attained infant length-for-age z scores (LAZ) at 6 mo of age. Secondary outcomes included exclusive breastfeeding proportion reported by the mother, maternal BMI and midupper arm circumference (MUAC), hemoglobin concentrations in mothers and infants, and the proportion of anemic infants at 6 mo of age. RESULTS We enrolled 816 mother-infant dyads. The intervention did not achieve a significant effect on LAZ at 6 mo (adjusted mean difference: 0.09; 95% CI: -0.03, 0.20). Exclusive breastfeeding at 5 mo was higher (45.1% vs. 34.5%; RR: 1.31; 95% CI: 1.04, 1.64) in the intervention group compared with the controls. There were no significant effects on mean hemoglobin concentration or the proportion of anemic infants at 6 mo of age compared with the control group. We noted significant effects on maternal nutritional status (BMI, MUAC, hemoglobin concentration, and proportion anemic). CONCLUSIONS Postnatal supplementation of 600 kcal energy, 20 g protein, and multiple micronutrients daily to lactating mothers did not affect infant LAZ at age 6 mo. Such supplementation may improve maternal nutritional status. This trial was registered at Clinical Trials Registry-India as CTRI/2018/04/013095.",2021,"Exclusive breastfeeding at 5 mo was higher (45.1% vs. 34.5%; RR: 1.31; 95% CI: 1.04, 1.64) in the intervention group compared with the controls.","['We enrolled 816 mother-infant dyads', 'Eligible mother-infant dyads (infants', 'lactating mothers on the growth of their infants in the first 6 months of life', '≤7']","['snacks that were to be consumed daily, which provided 600 kcal of energy-with 25-30% of energy derived from fats', 'LAZ', 'nutritional interventions']","['attained infant length-for-age z scores (LAZ', 'maternal nutritional status', 'maternal nutritional status (BMI, MUAC, hemoglobin concentration, and proportion anemic', 'exclusive breastfeeding proportion reported by the mother, maternal BMI and midupper arm circumference (MUAC), hemoglobin concentrations', 'mean hemoglobin concentration']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0455806', 'cui_str': 'Infant length'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",816.0,0.114003,"Exclusive breastfeeding at 5 mo was higher (45.1% vs. 34.5%; RR: 1.31; 95% CI: 1.04, 1.64) in the intervention group compared with the controls.","[{'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Taneja', 'Affiliation': 'Center for Health Research and Development, Society for Applied Studies, New Delhi, India.'}, {'ForeName': 'Ravi Prakash', 'Initials': 'RP', 'LastName': 'Upadhyay', 'Affiliation': 'Center for Health Research and Development, Society for Applied Studies, New Delhi, India.'}, {'ForeName': 'Ranadip', 'Initials': 'R', 'LastName': 'Chowdhury', 'Affiliation': 'Center for Health Research and Development, Society for Applied Studies, New Delhi, India.'}, {'ForeName': 'Anura V', 'Initials': 'AV', 'LastName': 'Kurpad', 'Affiliation': ""Department of Physiology, St John's Medical College, Bengaluru, India.""}, {'ForeName': 'Himani', 'Initials': 'H', 'LastName': 'Bhardwaj', 'Affiliation': 'Center for Health Research and Development, Society for Applied Studies, New Delhi, India.'}, {'ForeName': 'Tivendra', 'Initials': 'T', 'LastName': 'Kumar', 'Affiliation': 'Center for Health Research and Development, Society for Applied Studies, New Delhi, India.'}, {'ForeName': 'Pratibha', 'Initials': 'P', 'LastName': 'Dwarkanath', 'Affiliation': ""Department of Physiology, St John's Medical College, Bengaluru, India.""}, {'ForeName': 'Beena', 'Initials': 'B', 'LastName': 'Bose', 'Affiliation': ""Department of Physiology, St John's Medical College, Bengaluru, India.""}, {'ForeName': 'Sarita', 'Initials': 'S', 'LastName': 'Devi', 'Affiliation': ""Department of Physiology, St John's Medical College, Bengaluru, India.""}, {'ForeName': 'Gunjan', 'Initials': 'G', 'LastName': 'Kumar', 'Affiliation': 'Center for Health Research and Development, Society for Applied Studies, New Delhi, India.'}, {'ForeName': 'Baljeet', 'Initials': 'B', 'LastName': 'Kaur', 'Affiliation': 'Center for Health Research and Development, Society for Applied Studies, New Delhi, India.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Bahl', 'Affiliation': 'Department of Maternal, Newborn, Child, and Adolescent Health, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Nita', 'Initials': 'N', 'LastName': 'Bhandari', 'Affiliation': 'Center for Health Research and Development, Society for Applied Studies, New Delhi, India.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa383'] 2162,33568383,Roxadustat for Treating Anemia in Patients with CKD Not on Dialysis: Results from a Randomized Phase 3 Study.,"BACKGROUND Current anemia therapies for patients with non-dialysis-dependent CKD may require injection and medical visits. Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, stimulates erythropoiesis and improves iron homeostasis. METHODS In this double-blind phase 3 study, we randomized patients with non-dialysis-dependent CKD stages 3-5 and hemoglobin <10.0 g/dl (1:1) to thrice-weekly 70-mg oral roxadustat or placebo. Doses were titrated throughout the study based on hemoglobin levels. The primary efficacy end point was mean change from baseline in hemoglobin averaged over weeks 28-52 versus placebo, irrespective of rescue therapy use. We assessed patients for adverse events. RESULTS The study included 2781 patients, 1393 who received roxadustat and 1388 who received placebo. Mean baseline hemoglobin was 9.1 g/dl for both groups. The mean change in hemoglobin from baseline was 1.75 g/dl (95% confidence interval [95% CI], 1.68 to 1.81) with roxadustat versus 0.40 g/dl (95% CI, 0.33 to 0.47) with placebo, ( P <0.001). Among 411 patients with baseline elevated high-sensitivity C-reactive protein, mean change in hemoglobin from baseline was 1.75 g/dl (95% CI, 1.58 to 1.92) with roxadustat versus 0.62 g/dl (95% CI, 0.44 to 0.80) with placebo, ( P <0.001). Roxadustat reduced the risk of red blood cell transfusion by 63% (hazard ratio, 0.37; 95% CI, 0.30 to 0.44). The most common adverse events with roxadustat and placebo, respectively, were ESKD (21.0% versus 20.5%), urinary tract infection (12.8% versus 8.0%), pneumonia (11.9% versus 9.4%), and hypertension (11.5% versus 9.1%). CONCLUSIONS Roxadustat effectively increased hemoglobin in patients with non-dialysis-dependent CKD and reduced the need for red blood cell transfusion, with an adverse event profile comparable to that of placebo. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With CKD, Not on Dialysis, NCT02174627.",2021,"Roxadustat reduced the risk of red blood cell transfusion by 63% (hazard ratio, 0.37; 95% CI, 0.30 to 0.44).","['Patients with CKD Not on Dialysis', 'patients with non-dialysis-dependent CKD stages 3-5 and hemoglobin <10.0 g/dl (1:1) to', '411 patients with baseline elevated high', 'patients with non-dialysis-dependent CKD may require injection and medical visits', '2781 patients, 1393 who received roxadustat and 1388 who received']","['placebo', 'thrice-weekly 70-mg oral roxadustat or placebo']","['sensitivity C-reactive protein, mean change in hemoglobin', 'Mean baseline hemoglobin', 'hemoglobin', 'pneumonia', 'mean change from baseline in hemoglobin', 'hypertension', 'urinary tract infection', 'risk of red blood cell transfusion', 'mean change in hemoglobin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C2316787', 'cui_str': 'Chronic kidney disease stage 3'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0086252', 'cui_str': 'Transfusion of red blood cells'}]",2781.0,0.538988,"Roxadustat reduced the risk of red blood cell transfusion by 63% (hazard ratio, 0.37; 95% CI, 0.30 to 0.44).","[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Fishbane', 'Affiliation': 'Department of Medicine, Zucker School of Medicine at Hofstra/Northwell Health, Great Neck, New York sfishbane@northwell.edu.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'El-Shahawy', 'Affiliation': 'Department of Medicine, Keck-University of Southern California School of Medicine, Los Angeles, California.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Pecoits-Filho', 'Affiliation': 'School of Medicine, Pontifical Catholic University of Parana, Curitiba, Brazil.'}, {'ForeName': 'Bui Pham', 'Initials': 'BP', 'LastName': 'Van', 'Affiliation': 'Department of Medicine, Pham Ngoc Thach University of Medicine, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Houser', 'Affiliation': 'Global Medicines Development, Biopharmaceuticals Research & Development, AstraZeneca Gaithersburg, Gaithersburg, Maryland.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Frison', 'Affiliation': 'Biostatistics, Biopharmaceuticals Research & Development, AstraZeneca Gothenburg, Mölndal, Sweden.'}, {'ForeName': 'Dustin J', 'Initials': 'DJ', 'LastName': 'Little', 'Affiliation': 'Global Medicines Development, Biopharmaceuticals Research & Development, AstraZeneca Gaithersburg, Gaithersburg, Maryland.'}, {'ForeName': 'Nicolas J', 'Initials': 'NJ', 'LastName': 'Guzman', 'Affiliation': 'Global Medicines Development, Biopharmaceuticals Research & Development, AstraZeneca Gaithersburg, Gaithersburg, Maryland.'}, {'ForeName': 'Pablo E', 'Initials': 'PE', 'LastName': 'Pergola', 'Affiliation': 'Renal Associates PA, San Antonio, Texas.'}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2020081150'] 2163,33576037,The HEAR-VA Pilot Study: Hearing Assistance Provided to Older Adults in the Emergency Department.,"BACKGROUND/OBJECTIVES Poor communication is a barrier to care for people with hearing loss. We assessed the feasibility and potential benefit of providing a simple hearing assistance device during an emergency department (ED) visit, for people who reported difficulty hearing. DESIGN Randomized controlled pilot study. SETTING The ED of New York Harbor Manhattan Veterans Administration Medical Center. PARTICIPANTS One hundred and thirty-three Veterans aged 60 and older, presenting to the ED, likely to be discharged to home, who either (1) said that they had difficulty hearing, or (2) scored 10 or greater (range 0-40) on the Hearing Handicap Inventory-Survey (HHI-S). INTERVENTION Subjects were randomized (1:1), and intervention subjects received a personal amplifier (PA; Williams Sound Pocketalker 2.0) for use during their ED visit. MEASUREMENTS Three survey instruments: (1) six-item Hearing and Understanding Questionnaire (HUQ); (2) three-item Care Transitions Measure; and (3) three-item Patient Understanding of Discharge Information. Post-ED visit phone calls to assess ED returns. RESULTS Of the 133 subjects, 98.3% were male; mean age was 76.4 years (standard deviation (SD) = 9.2). Mean HHI-S score was 19.2 (SD = 8.3). Across all HUQ items, intervention subjects reported better in-ED experience than controls. Seventy-five percent of intervention subjects agreed or strongly agreed that ability to understand what was said was without effort versus 56% for controls. Seventy-five percent of intervention subjects versus 36% of controls said clinicians provided them with an explanation about presenting problems. Three percent of intervention subjects had an ED revisit within 3 days compared with 9.0% controls. CONCLUSION Veterans with hearing difficulties reported improved in-ED experiences with use of PAs, and were less likely to return to the ED within 3 days. PAs may be an important adjunct to older patient ED care but require validation in a larger more definitive randomized controlled trial.",2021,Seventy-five percent of intervention subjects agreed or strongly agreed that ability to understand what was said was without effort versus 56% for controls.,"['people who reported difficulty hearing', 'Of the 133 subjects, 98.3% were male; mean age was 76.4\u2009years (standard deviation (SD) = 9.2', 'The ED of New York Harbor Manhattan Veterans Administration Medical Center', 'Older Adults in the Emergency Department', 'One hundred and thirty-three Veterans aged 60 and older, presenting to the ED, likely to be discharged to home, who either (1) said that they had difficulty hearing, or (2) scored 10 or greater (range 0-40) on the Hearing Handicap Inventory-Survey (HHI-S', 'people with hearing loss']","['simple hearing assistance device', 'personal amplifier (PA; Williams Sound Pocketalker 2.0) for use during their ED visit']","['ED revisit', 'six-item Hearing and Understanding Questionnaire (HUQ); (2) three-item Care Transitions Measure; and (3) three-item Patient Understanding of Discharge Information', 'Mean HHI-S score']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0018772', 'cui_str': 'Partial deafness'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C5191219', 'cui_str': '9.2'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0184713', 'cui_str': 'Discharge to home'}, {'cui': 'C0080151', 'cui_str': 'Simian AIDS'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}]","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0002684', 'cui_str': 'Electronic Amplifiers'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}]","[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4019079', 'cui_str': 'Care Transition'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",133.0,0.073384,Seventy-five percent of intervention subjects agreed or strongly agreed that ability to understand what was said was without effort versus 56% for controls.,"[{'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Chodosh', 'Affiliation': 'VA New York Harbor Healthcare System, New York, New York, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Goldfeld', 'Affiliation': 'Division of Biostatistics, Department of Population Health, NYU Grossman School of Medicine, New York, New York, USA.'}, {'ForeName': 'Barbara E', 'Initials': 'BE', 'LastName': 'Weinstein', 'Affiliation': 'Division of Geriatrics and Palliative Care, Department of Medicine, NYU Grossman School of Medicine, New York, New York, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Radcliffe', 'Affiliation': 'VA New York Harbor Healthcare System, New York, New York, USA.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Burlingame', 'Affiliation': 'VA New York Harbor Healthcare System, New York, New York, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Dickson', 'Affiliation': 'Rory Meyers College of Nursing, New York University, New York, New York, USA.'}, {'ForeName': 'Corita', 'Initials': 'C', 'LastName': 'Grudzen', 'Affiliation': 'Department of Population Health, NYU Grossman School of Medicine, New York, New York, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Sherman', 'Affiliation': 'VA New York Harbor Healthcare System, New York, New York, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Smilowitz', 'Affiliation': 'VA New York Harbor Healthcare System, New York, New York, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Blustein', 'Affiliation': 'Department of Population Health, NYU Grossman School of Medicine, New York, New York, USA.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.17037'] 2164,33573994,"Child Involvement in Choosing a Recipe, Purchasing Ingredients, and Cooking at School Increases Willingness to Try New Foods and Reduces Food Neophobia.","OBJECTIVE To investigate the effect of involving children in their feeding process (choosing a recipe, purchasing the ingredients, and cooking) on their lunch food choice in a school environment. DESIGN Quasi-experimental. SETTING Two schools in Bilbao, Spain. PARTICIPANTS A total of 202 children (aged 8-9 years) participated in the study (43% girls), with 99 in the nutrition education (NE) group and 103 in the hands-on (HO) group. INTERVENTION Three 1-hour workshops (1 workshop/wk), different for each group: HO, cooking-related activities, and NE, healthy habits promotion through nutrition education activities. MAIN OUTCOME MEASURES Food neophobia, diet quality, cooking self-efficacy and attitudes toward cooking, and food intake and selection of the experimental lunches. ANALYSIS Chi-square test of independence, ANCOVA, and t tests were performed. RESULTS Students from the HO group selected and ate more spinach/broccoli (P < 0.001 and P = 0.02, respectively) for the first lunch; and selected more spinach/broccoli (P = 0.04) for the second lunch. After the intervention, improvements were observed for spinach liking and neophobia for the HO group and cooking self-efficacy and KidMed score for both groups. CONCLUSIONS AND IMPLICATIONS Both interventions succeeded in improving children's diet quality, but only the HO group reduced food neophobia levels. Therefore, involving children in choosing a recipe, purchasing ingredients, and cooking may promote changing eating behaviors toward healthy habits such as increasing vegetable consumption.",2021,"RESULTS Students from the HO group selected and ate more spinach/broccoli (P < 0.001 and P = 0.02, respectively) for the first lunch; and selected more spinach/broccoli (P = 0.04) for the second lunch.","['A total of 202 children (aged 8-9 years) participated in the study (43% girls), with 99 in the nutrition education (NE) group and 103 in the hands-on (HO) group', 'Two schools in Bilbao, Spain']",[],"['Food neophobia, diet quality, cooking self-efficacy and attitudes toward cooking, and food intake and selection', 'spinach liking and neophobia for the HO group and cooking self-efficacy and KidMed score', ""children's diet quality"", 'spinach/broccoli', 'food neophobia levels']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]",[],"[{'cui': 'C3840121', 'cui_str': 'Avoidant restrictive food intake disorder'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0242949', 'cui_str': 'Spinach'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0330498', 'cui_str': 'Brassica oleracea'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",202.0,0.0209524,"RESULTS Students from the HO group selected and ate more spinach/broccoli (P < 0.001 and P = 0.02, respectively) for the first lunch; and selected more spinach/broccoli (P = 0.04) for the second lunch.","[{'ForeName': 'Edurne', 'Initials': 'E', 'LastName': 'Maiz', 'Affiliation': 'Department of Clinical and Health Psychology and Research Methodology, Faculty of Psychology, University of the Basque Country (UPV/EHU), Donostia-San Sebastián, Guipúzcoa, Spain; BCCInnovation, Technological Center of Gastronomy, Paseo Juan Avelino Barriola, Donostia-San Sebastián, Guipúzcoa, Spain. Electronic address: edurne.maiz@ehu.eus.'}, {'ForeName': 'Iratxe', 'Initials': 'I', 'LastName': 'Urkia-Susin', 'Affiliation': 'BCCInnovation, Technological Center of Gastronomy, Paseo Juan Avelino Barriola, Donostia-San Sebastián, Guipúzcoa, Spain; Pharmacy and Food Sciences, Faculty of Pharmacy, University of the Basque Country (UPV/EHU), Vitoria-Gasteiz, Álava, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Urdaneta', 'Affiliation': 'BCCInnovation, Technological Center of Gastronomy, Paseo Juan Avelino Barriola, Donostia-San Sebastián, Guipúzcoa, Spain; Euskampus, Cooperative Innovation, Leioa, Vizcaya, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Allirot', 'Affiliation': 'BCCInnovation, Technological Center of Gastronomy, Paseo Juan Avelino Barriola, Donostia-San Sebastián, Guipúzcoa, Spain.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2020.12.015'] 2165,33577770,"Real-time continuous glucose monitoring in preterm infants (REACT): an international, open-label, randomised controlled trial.","BACKGROUND Hyperglycaemia and hypoglycaemia are common in preterm infants and have been associated with increased risk of mortality and morbidity. Interventions to reduce risk associated with these exposures are particularly challenging due to the infrequent measurement of blood glucose concentrations, with the potential of causing more harm instead of improving outcomes for these infants. Continuous glucose monitoring (CGM) is widely used in adults and children with diabetes to improve glucose control, but has not been approved for use in neonates. The REACT trial aimed to evaluate the efficacy and safety of CGM in preterm infants requiring intensive care. METHODS This international, open-label, randomised controlled trial was done in 13 neonatal intensive care units in the UK, Spain, and the Netherlands. Infants were included if they were within 24 h of birth, had a birthweight of 1200 g or less, had a gestational age up to 33 weeks plus 6 days, and had parental written informed consent. Infants were randomly assigned (1:1) to real-time CGM or standard care (with masked CGM for comparison) using a central web randomisation system, stratified by recruiting centre and gestational age (<26 or ≥26 weeks). The primary efficacy outcome was the proportion of time sensor glucose concentration was 2·6-10 mmol/L for the first week of life. Safety outcomes related to hypoglycaemia (glucose concentrations <2·6 mmol/L) in the first 7 days of life. All outcomes were assessed on the basis of intention to treat in the full analysis set with available data. The study is registered with the International Standard Randomised Control Trials Registry, ISRCTN12793535. FINDINGS Between July 4, 2016, and Jan 27, 2019, 182 infants were enrolled, 180 of whom were randomly assigned (85 to real-time CGM, 95 to standard care). 70 infants in the real-time CGM intervention group and 85 in the standard care group had CGM data and were included in the primary analysis. Compared with infants in the standard care group, infants managed using CGM had more time in the 2·6-10 mmol/L glucose concentration target range (mean proportion of time 84% [SD 22] vs 94% [11]; adjusted mean difference 8·9% [95% CI 3·4-14·4]), equivalent to 13 h (95% CI 5-21). More infants in the standard care group were exposed to at least one episode of sensor glucose concentration of less than 2·6 mmol/L for more than 1 h than those in the intervention group (13 [15%] of 85 vs four [6%] of 70). There were no serious adverse events related to the use of the device or episodes of infection. INTERPRETATION Real-time CGM can reduce exposure to prolonged or severe hyperglycaemia and hypoglycaemia. Further studies using CGM are required to determine optimal glucose targets, strategies to obtain them, and the potential effect on long-term health outcomes. FUNDING National Institute for Health Research Efficacy and Mechanisms Evaluation Programme.",2021,"There were no serious adverse events related to the use of the device or episodes of infection. ","['Between July 4, 2016, and Jan 27, 2019, 182 infants were enrolled, 180 of whom were randomly assigned (85 to real-time CGM, 95 to standard care', 'preterm infants (REACT', 'preterm infants', 'preterm infants requiring intensive care', 'Infants were included if they were within 24 h of birth, had a birthweight of 1200 g or less, had a gestational age up to 33 weeks plus 6 days, and had parental written informed consent', '13 neonatal intensive care units in the UK, Spain, and the Netherlands', 'adults and children with diabetes', '70 infants in the real-time CGM intervention group and 85 in the standard care group had CGM data and were included in the primary analysis']","['CGM', 'Continuous glucose monitoring (CGM', 'real-time CGM or standard care (with masked CGM for comparison']","['proportion of time sensor glucose concentration', 'efficacy and safety', 'sensor glucose concentration', 'hypoglycaemia (glucose concentrations <2·6 mmol/L']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C4224854', 'cui_str': 'React'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}]",182.0,0.141351,"There were no serious adverse events related to the use of the device or episodes of infection. ","[{'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Beardsall', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge, UK; Neonatal Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK. Electronic address: kb274@cam.ac.uk.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Thomson', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge, UK; Neonatal Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Guy', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Iglesias-Platas', 'Affiliation': 'Neonatal Unit, Institut de Recerca, Sant Joan de Déu, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Mirjam M', 'Initials': 'MM', 'LastName': 'van Weissenbruch', 'Affiliation': 'Department of Paediatrics, VU University Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Bond', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Annabel', 'Initials': 'A', 'LastName': 'Allison', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Sungwook', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Warwick Clinical Trials Unit, The University of Warwick, Coventry, UK.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Petrou', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford Radcliffe Observatory Quarter, University of Oxford, Oxford, UK.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Pantaleo', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hovorka', 'Affiliation': 'Wellcome Trust MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dunger', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge, UK; Wellcome Trust MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(20)30367-9'] 2166,33581283,Cortical plasticity is correlated with cognitive improvement in Alzheimer's disease patients after rTMS treatment.,"OBJECTIVE Repetitive transcranial magnetic stimulation (rTMS) has been widely used in non-invasive treatments for different neurological disorders. Few biomarkers are available for treatment response prediction. This study aims to analyze the correlation between changes in long-term potentiation (LTP)-like cortical plasticity and cognitive function in patients with Alzheimer's disease (AD) that underwent rTMS treatment. METHODS A total of 75 AD patients were randomized into either 20 Hz rTMS treatment at the dorsolateral prefrontal cortex (DLPFC) group (n = 37) or a sham treatment group (n = 38) for 30 sessions over six weeks (five days per week) with a three-month follow-up. Neuropsychological assessments were conducted using the Mini-Mental State Examination (MMSE) and Alzheimer's Disease Assessment-Cognitive Component (ADAS-Cog). The cortical plasticity reflected by the motor-evoked potential (MEP) before and after high-frequency repetitive TMS to the primary motor cortex (M1) was also examined prior to and after the treatment period. RESULTS The results showed that the cognitive ability of patients who underwent the MMSE and ADAS-Cog assessments showed small but significant improvement after six weeks of rTMS treatment compared with the sham group. The cortical plasticity improvement correlated to the observed cognition change. CONCLUSIONS Cortical LTP-like plasticity could predict the treatment responses of cognitive improvements in AD patients receiving rTMS intervention. This warrants future clinical trials using cortical LTP as a predictive marker.",2021,"The cortical plasticity reflected by the motor-evoked potential (MEP) before and after high-frequency repetitive TMS to the primary motor cortex (M1) was also examined prior to and after the treatment period. ","['AD patients receiving rTMS intervention', ""Alzheimer's disease patients after rTMS treatment"", ""patients with Alzheimer's disease (AD) that underwent rTMS treatment"", '75 AD patients']","['20 Hz rTMS treatment at the dorsolateral prefrontal cortex (DLPFC', 'rTMS', 'Repetitive transcranial magnetic stimulation (rTMS']","['cognitive ability', ""Mini-Mental State Examination (MMSE) and Alzheimer's Disease Assessment-Cognitive Component (ADAS-Cog""]","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}]","[{'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",75.0,0.0409499,"The cortical plasticity reflected by the motor-evoked potential (MEP) before and after high-frequency repetitive TMS to the primary motor cortex (M1) was also examined prior to and after the treatment period. ","[{'ForeName': 'Xingxing', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Ningbo Kangning Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Gangqiao', 'Initials': 'G', 'LastName': 'Qi', 'Affiliation': ""Taizhou Second People's Hospital, Taizhou, Zhejiang, China.""}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Ningbo Kangning Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Guomin', 'Initials': 'G', 'LastName': 'Lian', 'Affiliation': 'Ningbo Kangning Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Ningbo Kangning Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Shaochang', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': ""The Second People's Hospital of Lishui, Lishui, Zhejiang, China. Electronic address: seywsc@163.com.""}, {'ForeName': 'Ti-Fei', 'Initials': 'TF', 'LastName': 'Yuan', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Co-innovation Center of Neuroregeneration, Nantong University, Nantong, Jiangsu, China. Electronic address: ytf0707@126.com.'}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': 'Ningbo Kangning Hospital, Ningbo, Zhejiang, China. Electronic address: wyzhouds@sina.com.'}]",Brain stimulation,['10.1016/j.brs.2021.01.012'] 2167,33583000,The sarcopenia and physical frailty in older people: multi-component treatment strategies (SPRINTT) project: description and feasibility of a nutrition intervention in community-dwelling older Europeans.,"BACKGROUND The ""Sarcopenia and Physical Frailty in Older People: Multicomponent Treatment Strategies"" (SPRINTT) project sponsored a multi-center randomized controlled trial (RCT) with the objective to determine the effect of physical activity and nutrition intervention for prevention of mobility disability in community-dwelling frail older Europeans. We describe here the design and feasibility of the SPRINTT nutrition intervention, including techniques used by nutrition interventionists to identify those at risk of malnutrition and to carry out the nutrition intervention. METHODS SPRINTT RCT recruited older adults (≥ 70 years) from 11 European countries. Eligible participants (n = 1517) had functional limitations measured with Short Physical Performance Battery (SPPB score 3-9) and low muscle mass as determined by DXA scans, but were able to walk 400 m without assistance within 15 min. Participants were followed up for up to 3 years. The nutrition intervention was carried out mainly by individual nutrition counseling. Nutrition goals included achieving a daily protein intake of 1.0-1.2 g/kg body weight, energy intake of 25-30 kcal/kg of body weight/day, and serum vitamin D concentration ≥ 75 mmol/L. Survey on the method strategies and feasibility of the nutrition intervention was sent to all nutrition interventionists of the 16 SPRINTT study sites. RESULTS Nutrition interventionists from all study sites responded to the survey. All responders found that the SPRINTT nutrition intervention was feasible for the target population, and it was well received by the majority. The identification of participants at nutritional risk was accomplished by combining information from interviews, questionnaires, clinical and laboratory data. Although the nutrition intervention was mainly carried out using individual nutritional counselling, other assisting methods were used as appropriate. CONCLUSION The SPRINTT nutrition intervention was feasible and able to adapt flexibly to varying needs of this heterogeneous population. The procedures adopted to identify older adults at risk of malnutrition and to design the appropriate intervention may serve as a model to deliver nutrition intervention for community-dwelling older people with mobility limitations.",2021,"All responders found that the SPRINTT nutrition intervention was feasible for the target population, and it was well received by the majority.","['Eligible participants (n\u2009=\u20091517) had functional limitations measured with Short Physical Performance Battery (SPPB score 3-9) and low muscle mass as determined by DXA scans, but were able to walk 400\xa0m without assistance within 15\xa0min', 'Older People', 'SPRINTT RCT recruited older adults (≥\u200970\xa0years) from 11 European countries', 'older people', 'community-dwelling older Europeans', 'older adults at risk of malnutrition', 'community-dwelling frail older Europeans', 'community-dwelling older people with mobility limitations']","['physical activity and nutrition intervention', 'nutrition intervention', 'SPRINTT nutrition intervention']",['mobility disability'],"[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C2712089', 'cui_str': 'Able to walk'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C1565249', 'cui_str': 'Mobility Limitation'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",,0.0195684,"All responders found that the SPRINTT nutrition intervention was feasible for the target population, and it was well received by the majority.","[{'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Jyväkorpi', 'Affiliation': 'Clinicum, Department of General Practice, Helsinki University Central Hospital, University of Helsinki, Tukholmankatu 8 B, 00014, Helsinki, Finland. satu.jyvakorpi@gery.fi.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ramel', 'Affiliation': 'The Icelandic Gerontological Research Center, The National University Hospital of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'T E', 'Initials': 'TE', 'LastName': 'Strandberg', 'Affiliation': 'Clinicum, Department of General Practice, Helsinki University Central Hospital, University of Helsinki, Tukholmankatu 8 B, 00014, Helsinki, Finland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Piotrowicz', 'Affiliation': 'Faculty of Medicine, Department of Internal Medicine and Gerontology, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Błaszczyk-Bębenek', 'Affiliation': 'Department of Nutrition and Drug Research, Institute of Public Health, Faculty of Health Science, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Urtamo', 'Affiliation': 'Clinicum, Department of General Practice, Helsinki University Central Hospital, University of Helsinki, Tukholmankatu 8 B, 00014, Helsinki, Finland.'}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Rempe', 'Affiliation': 'Institute for Biomedicine of Aging, Friedrich-Alexander-University of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Ó', 'Initials': 'Ó', 'LastName': 'Geirsdóttir', 'Affiliation': 'The Icelandic Gerontological Research Center, The National University Hospital of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Vágnerová', 'Affiliation': '1St Faculty of Medicine, Department of Gerontology & Geriatrics, Charles University in Prague, General University Hospital Prague, Nové Město, Czech Republic.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Billot', 'Affiliation': 'PRISMATICS Lab (Predictive Research In Spine/Neuromodulation Management And Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, Poitiers, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Larreur', 'Affiliation': 'Department of Geriatrics, University Hospital of Limoges, Limoges, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Savera', 'Affiliation': 'Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Soriano', 'Affiliation': 'Gérontopôle, Centre Hospitalier Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Picauron', 'Affiliation': 'Gérontopôle, Centre Hospitalier Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tagliaferri', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sanchez-Puelles', 'Affiliation': 'University Hospital Getafe, Madrid, Spain.'}, {'ForeName': 'V Sánchez', 'Initials': 'VS', 'LastName': 'Cadenas', 'Affiliation': 'University Hospital Ramon Y Cajal Madrid, Madrid, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Perl', 'Affiliation': 'Medical University of Graz, Graz, Austria.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Tirrel', 'Affiliation': 'Diabetes Frail, Medici Medical Practice, Luton, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Öhman', 'Affiliation': 'Clinicum, Department of General Practice, Helsinki University Central Hospital, University of Helsinki, Tukholmankatu 8 B, 00014, Helsinki, Finland.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Weling-Scheepers', 'Affiliation': 'Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ambrosi', 'Affiliation': 'IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Costantini', 'Affiliation': 'IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Pavelková', 'Affiliation': 'Silesian Hospital, Opava, Czech Republic.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Klimkova', 'Affiliation': 'Silesian Hospital, Opava, Czech Republic.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Freiberger', 'Affiliation': '1St Faculty of Medicine, Department of Gerontology & Geriatrics, Charles University in Prague, General University Hospital Prague, Nové Město, Czech Republic.'}, {'ForeName': 'P V', 'Initials': 'PV', 'LastName': 'Jonsson', 'Affiliation': 'The Icelandic Gerontological Research Center, The National University Hospital of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Marzetti', 'Affiliation': 'Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'K H', 'Initials': 'KH', 'LastName': 'Pitkälä', 'Affiliation': 'Clinicum, Department of General Practice, Helsinki University Central Hospital, University of Helsinki, Tukholmankatu 8 B, 00014, Helsinki, Finland.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Landi', 'Affiliation': 'Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Calvani', 'Affiliation': 'Fondazione Policlinico Universitario ""A. Gemelli"" IRCCS, Rome, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European geriatric medicine,['10.1007/s41999-020-00438-4'] 2168,33582788,Effective recruitment strategies for African-American men and women: the Nutritious Eating with Soul study.,"Previous studies have found it challenging to recruit African-American (AA) participants into health education research studies. The goal of this article is to describe the recruitment methods used for the Nutritious Eating with Soul (NEW Soul) study, a 2-year randomized behavioral health education intervention, conducted in two cohorts, with emphasis on methods used for reaching men. Participants indicated how they learned about the study on an online screening questionnaire from a list of the recruitment strategies we employed. Due to limited recruitment of men in Cohort 1, recruitment strategies for Cohort 2 focused on reaching men. Across the two cohorts, a total of 568 (23% men) participants completed the online screener and 159 (21% men) completed all baseline assessments and enrolled in the study. The most effective methods for completing screening questionnaires were radio ads, referrals from friends and family, TV interviews, social media posts and community events. Men were primarily recruited via radio ads, whereas women were more often recruited through TV and social media. Radio was an effective way to recruit AA adults into nutrition interventions, particularly men. In addition, low-cost methods, such as personal referrals, social media posts and community events were also effective strategies.",2021,"The most effective methods for completing screening questionnaires were radio ads, referrals from friends and family, TV interviews, social media posts and community events.","['African-American men and women', 'Nutritious Eating with Soul (NEW Soul) study, a 2-year randomized behavioral health education intervention, conducted in two cohorts, with emphasis on methods used for reaching men', 'Men were primarily recruited via radio ads, whereas women were more often recruited through TV and social media', 'two cohorts, a total of 568 (23% men) participants completed the online screener and 159 (21% men) completed all baseline assessments and enrolled in the study']",[],[],"[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0034546', 'cui_str': 'Radio'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",[],[],568.0,0.0294487,"The most effective methods for completing screening questionnaires were radio ads, referrals from friends and family, TV interviews, social media posts and community events.","[{'ForeName': 'Gabrielle M', 'Initials': 'GM', 'LastName': 'Turner-McGrievy', 'Affiliation': 'Department of Health Promotion, Education, and Behavior, Arnold School of Public Health, University of South Carolina, 915 Greene Street, Columbia, SC 29208, USA.'}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Wilson', 'Affiliation': 'Prevention Research Center, Arnold School of Public Health, University of South Carolina, 921 Assembly Street, Columbia, SC 29208, USA.'}, {'ForeName': 'Shiba', 'Initials': 'S', 'LastName': 'Bailey', 'Affiliation': 'Prevention Research Center, Arnold School of Public Health, University of South Carolina, 921 Assembly Street, Columbia, SC 29208, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Bernhart', 'Affiliation': 'Department of Health Promotion, Education, and Behavior, Arnold School of Public Health, University of South Carolina, 915 Greene Street, Columbia, SC 29208, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wilcox', 'Affiliation': 'Prevention Research Center, Arnold School of Public Health, University of South Carolina, 921 Assembly Street, Columbia, SC 29208, USA.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Frongillo', 'Affiliation': 'Department of Health Promotion, Education, and Behavior, Arnold School of Public Health, University of South Carolina, 915 Greene Street, Columbia, SC 29208, USA.'}, {'ForeName': 'E Angela', 'Initials': 'EA', 'LastName': 'Murphy', 'Affiliation': 'Department of Pathology, Microbiology and Immunology, School of Medicine, University of South Carolina, 6439 Garners Ferry Rd, Columbia, SC 29209, USA.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Hutto', 'Affiliation': 'Prevention Research Center, Arnold School of Public Health, University of South Carolina, 921 Assembly Street, Columbia, SC 29208, USA.'}]",Health education research,['10.1093/her/cyab003'] 2169,33587894,Circulating tumour DNA in patients with advanced melanoma treated with dabrafenib or dabrafenib plus trametinib: a clinical validation study.,"BACKGROUND Melanoma lacks validated blood-based biomarkers for monitoring and predicting treatment efficacy. Cell-free circulating tumour DNA (ctDNA) is a promising biomarker; however, various detection methods have been used, and, to date, no large studies have examined the association between serial changes in ctDNA and survival after BRAF, MEK, or BRAF plus MEK inhibitor therapy. We aimed to evaluate whether baseline ctDNA concentrations and kinetics could predict survival outcomes. METHODS In this clinical validation study, we used analytically validated droplet digital PCR assays to measure BRAF V600 -mutant ctDNA in pretreatment and on-treatment plasma samples from patients aged 18 years or older enrolled in two clinical trials. COMBI-d (NCT01584648) was a double-blind, randomised phase 3 study of dabrafenib plus trametinib versus dabrafenib plus placebo in previously untreated patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. Patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. COMBI-MB (NCT02039947) was an open-label, non-randomised, phase 2 study evaluating dabrafenib plus trametinib in patients with BRAF V600 mutation-positive metastatic melanoma and brain metastases. Patients in cohort A of COMBI-MB had asymptomatic brain metastases, no previous local brain-directed therapy, and an ECOG performance status of 0 or 1. Biomarker analysis was a prespecified exploratory endpoint in both trials and performed in the intention-to-treat populations in COMBI-d and COMBI-MB. We investigated the association between mutant copy number (baseline or week 4 or zero conversion status) and efficacy endpoints (progression-free survival, overall survival, and best overall response). We used Cox models, Kaplan-Meier plots, and log-rank tests to explore the association of pretreatment ctDNA concentrations with progression-free survival and overall survival. The effect of additional prognostic variables such as lactate dehydrogenase was also investigated in addition to the mutant copy number. FINDINGS In COMBI-d, pretreatment plasma samples were available from 345 (82%) of 423 patients and on-treatment (week 4) plasma samples were available from 224 (53%) of 423 patients. In cohort A of COMBI-MB, pretreatment and on-treatment samples were available from 38 (50%) of 76 patients with intracranial and extracranial metastatic melanoma. ctDNA was detected in pretreatment samples from 320 (93%) of 345 patients (COMBI-d) and 34 (89%) of 38 patients (COMBI-MB). When assessed as a continuous variable, elevated baseline BRAF V600 mutation-positive ctDNA concentration was associated with worse overall survival outcome (hazard ratio [HR] 1·13 [95% CI 1·09-1·18], p<0·0001 by univariate analysis), independent of treatment group and baseline lactate dehydrogenase concentrations (1·08 [1·03-1·13], p=0·0020), in COMBI-d. A ctDNA cutoff point of 64 copies per mL of plasma stratified patients enrolled in COMBI-d as high risk or low risk with respect to survival outcomes (HR 1·74 [95% CI 1·37-2·21], p<0·0001 for progression-free survival; 2·23 [1·73-2·87], p<0·0001 for overall survival) and was validated in the COMBI-MB cohort (3·20 [1·39-7·34], p=0·0047 for progression-free survival; 2·94 [1·18-7·32], p=0·016 for overall survival). In COMBI-d, undetectable ctDNA at week 4 was significantly associated with extended progression-free and overall survival, particularly in patients with elevated lactate dehydrogenase concentrations (HR 1·99 [95% CI 1·08-3·64], p=0·027 for progression-free survival; 2·38 [1·24-4·54], p=0·0089 for overall survival). INTERPRETATION Pretreatment and on-treatment BRAF V600 -mutant ctDNA measurements could serve as independent, predictive biomarkers of clinical outcome with targeted therapy. FUNDING Novartis.",2021,"In COMBI-d, undetectable ctDNA at week 4 was significantly associated with extended progression-free and overall survival, particularly in patients with elevated lactate dehydrogenase concentrations (HR 1·99 [95% CI 1·08-3·64], p=0·027 for progression-free survival; 2·38 [1·24-4·54], p=0·0089 for overall survival). ","['1·13', 'previously untreated patients with BRAF V600 mutation-positive unresectable or metastatic melanoma', 'patients with advanced melanoma treated with', '76 patients with intracranial and extracranial metastatic melanoma', 'patients aged 18 years or older enrolled in two clinical trials', 'Patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', 'patients with BRAF V600 mutation-positive metastatic melanoma and brain metastases']","['dabrafenib or dabrafenib plus trametinib', 'dabrafenib plus trametinib versus dabrafenib plus placebo']","['extended progression-free and overall survival', 'survival outcomes', 'elevated lactate dehydrogenase concentrations', 'efficacy endpoints (progression-free survival, overall survival, and best overall response', 'ctDNA', 'overall survival outcome (hazard ratio [HR', 'overall survival', 'baseline lactate dehydrogenase concentrations']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0580586', 'cui_str': 'Extracranial'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}]","[{'cui': 'C3467876', 'cui_str': 'dabrafenib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2697961', 'cui_str': 'trametinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0151754', 'cui_str': '[D]Lactic acid dehydrogenase raised'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}]",423.0,0.610155,"In COMBI-d, undetectable ctDNA at week 4 was significantly associated with extended progression-free and overall survival, particularly in patients with elevated lactate dehydrogenase concentrations (HR 1·99 [95% CI 1·08-3·64], p=0·027 for progression-free survival; 2·38 [1·24-4·54], p=0·0089 for overall survival). ","[{'ForeName': 'Mahrukh M', 'Initials': 'MM', 'LastName': 'Syeda', 'Affiliation': 'NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Wiggins', 'Affiliation': 'NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Broderick C', 'Initials': 'BC', 'LastName': 'Corless', 'Affiliation': 'NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Melanoma Institute Australia, The University of Sydney, Royal North Shore and Mater Hospitals, Sydney, NSW, Australia.'}, {'ForeName': 'Keith T', 'Initials': 'KT', 'LastName': 'Flaherty', 'Affiliation': 'Dana-Farber Cancer Institute/Harvard Medical School and Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'University Hospital Essen, Essen, Germany; German Cancer Consortium, Heidelberg, Germany.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Nathan', 'Affiliation': 'East and North NHS Trust, Northwood, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Institute Gustave Roussy and Paris-Sud University, Villejuif, France.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Ribas', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Davies', 'Affiliation': 'Department of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jean Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Dermatology and Skin Cancer Department, Aix-Marseille University, Marseille, France.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Gasal', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Squires', 'Affiliation': 'Novartis Institute for BioMedical Research, Cambridge, MA, USA.'}, {'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Marker', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Garrett', 'Affiliation': 'Novartis Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Jan C', 'Initials': 'JC', 'LastName': 'Brase', 'Affiliation': 'Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Polsky', 'Affiliation': 'NYU Langone Health, New York, NY, USA. Electronic address: david.polsky@nyulangone.org.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30726-9'] 2170,33591484,The FamilyTalk randomized controlled trial: patient-reported outcomes in clinical genetic sequencing for colorectal cancer.,"As genetics gains favor in clinical oncology, it is important to address patient concerns around confidentiality, privacy, and security of genetic information that might otherwise limit its utilization. We designed a randomized controlled trial to assess the social impact of an online educational tool (FamilyTalk) to increase family communication about colorectal cancer (CRC) risk and screening. Of 208 randomized participants, 149 (71.6%) returned six-month surveys. Overall, there was no difference in CRC screening between the study arms. Privacy and confidentiality concerns about medical and genetic information, reactions to genetic test results, and lifestyle changes did not differ between arms. Participants with pathogenic or likely pathogenic (P/LP) and variant of uncertain significance (VUS) results were more likely than those with negative results to report that the results accurately predicted their disease risks (OR 5.37, p = 0.02 and OR 3.13, p = 0.02, respectively). This trial demonstrated no evidence that FamilyTalk impacted patient-reported outcomes. Low power, due to the limited number of participants with P/LP results in the overall sample, as well as the short follow-up period, could have contributed to the null findings.",2021,We designed a randomized controlled trial to assess the social impact of an online educational tool (FamilyTalk) to increase family communication about colorectal cancer (CRC) risk and screening.,"['Of 208 randomized participants, 149 (71.6%) returned six-month surveys']",['online educational tool (FamilyTalk'],"['CRC screening', 'disease risks']","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1281905', 'cui_str': 'At risk of disease'}]",208.0,0.0857292,We designed a randomized controlled trial to assess the social impact of an online educational tool (FamilyTalk) to increase family communication about colorectal cancer (CRC) risk and screening.,"[{'ForeName': 'Sukh', 'Initials': 'S', 'LastName': 'Makhnoon', 'Affiliation': 'Department of Behavioral Science, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Bowen', 'Affiliation': 'Department of Bioethics and Humanities, University of Washington, Seattle, WA, USA. dbowen@uw.edu.'}, {'ForeName': 'Brian H', 'Initials': 'BH', 'LastName': 'Shirts', 'Affiliation': 'Department of Laboratory Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Fullerton', 'Affiliation': 'Department of Bioethics and Humanities, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Eric B', 'Initials': 'EB', 'LastName': 'Larson', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Ralston', 'Affiliation': 'Genetic Services, Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Leppig', 'Affiliation': 'Genetic Services, Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Crosslin', 'Affiliation': 'Department of Biomedical Informatics and Medical Education, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Veenstra', 'Affiliation': 'Department of Pharmacy, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Gail P', 'Initials': 'GP', 'LastName': 'Jarvik', 'Affiliation': 'Departments of Medicine (Medical Genetics) and Genome Sciences, University of Washington Medical Center, Seattle, WA, USA.'}]",Cancer causes & control : CCC,['10.1007/s10552-021-01398-1'] 2171,33592827,COmmuNity-engaged SimULation Training for Blood Pressure Control (CONSULT-BP): A study protocol.,"BACKGROUND Healthcare professionals have negative implicit biases toward minority and poor patients. Few communication skills interventions target implicit bias as a factor contributing to disparities in health outcomes. We report the protocol from the COmmuNity-engaged SimULation Training for Blood Pressure Control (CONSULT-BP), a trial evaluating a novel educational and training intervention targeting graduate medical and nursing trainees that is designed to mitigate the effects of implicit bias in clinical encounters. The CONSULT-BP intervention combines knowledge acquisition, bias awareness, and practice of bias mitigating skills in simulation-based communication encounters with racially/ethnically diverse standardized patients. The trial evaluates the effect of this 3-part program on patient BP outcomes, self-reported patient medication adherence, patient-reported quality of provider communication, and trainee bias awareness. METHODS We are conducting a cluster randomized trial of the intervention among cohorts of internal medicine (IM), family medicine (FM), and nurse practitioner (NP) trainees at a single academic medical center. We are enrolling entire specialty cohorts of IM, FM, and NP trainees over a 3-year period, with each academic year constituting an intervention cycle. There are 3 cycles of implementation corresponding to 3 sequential academic years. Within each academic year, we randomize training times to 1 of 5 start dates using a stepped wedge design. The stepped wedge design compares outcomes within training clusters before and after the intervention, as well as across exposed and unexposed clusters. Primary outcome of blood pressure control is measured at the patient-level for patients clustered within trainees. Eligible patients for outcomes analysis are: English-speaking; non-White racial/ethnic minority; Medicaid recipient (regardless of race/ethnicity); hypertension; not have pregnancy, dementia, schizophrenia, bipolar illness, or other serious comorbidities that would interfere with hypertension self-control; not enrolled in hospice. Secondary outcomes include trainee bias awareness. A unique feature of this trial is the engagement of academic and community stakeholders to design, pilot test and implement a training program addressing healthcare. DISCUSSION Equipping clinicians with skills to mitigate implicit bias in clinical encounters is crucial to addressing persistent disparities in healthcare outcomes. Our novel, integrated approach may improve patient outcomes. TRIAL REGISTRATION NCT03375918. PROTOCOL VERSION 1.0 (November 10, 2020).",2021,"The CONSULT-BP intervention combines knowledge acquisition, bias awareness, and practice of bias mitigating skills in simulation-based communication encounters with racially/ethnically diverse standardized patients.","['Eligible patients for outcomes analysis are: English-speaking; non-White racial/ethnic minority; Medicaid recipient (regardless of race/ethnicity); hypertension', 'cohorts of internal medicine (IM), family medicine (FM), and nurse practitioner (NP) trainees at a single academic medical center', '1.0 (November 10, 2020']","['COmmuNity-engaged SimULation Training', '3-part program']","['Blood Pressure Control (CONSULT-BP', 'trainee bias awareness', 'patient BP outcomes, self-reported patient medication adherence, patient-reported quality of provider communication, and trainee bias awareness', 'blood pressure control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0028657', 'cui_str': 'Nurse practitioner'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",,0.0617109,"The CONSULT-BP intervention combines knowledge acquisition, bias awareness, and practice of bias mitigating skills in simulation-based communication encounters with racially/ethnically diverse standardized patients.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Tjia', 'Affiliation': 'University of Massachusetts Medical School.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Pugnaire', 'Affiliation': 'University of Massachusetts Medical School.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Calista', 'Affiliation': 'Center for Health Impact, Worcester.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Esparza', 'Affiliation': 'Center for Health Impact, Worcester.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Valdman', 'Affiliation': 'University of Massachusetts Medical School.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Garcia', 'Affiliation': 'University of Massachusetts Medical School.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Yazdani', 'Affiliation': 'University of Massachusetts Medical School.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Hale', 'Affiliation': 'University of Massachusetts Medical School.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Terrien', 'Affiliation': 'University of Massachusetts Medical School.'}, {'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Eisdorfer', 'Affiliation': 'University of Massachusetts Medical School.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Zolezzi-Wyndham', 'Affiliation': 'Promoting Good, LLC, Upton, Massachusetts.'}, {'ForeName': 'Germán', 'Initials': 'G', 'LastName': 'Chiriboga', 'Affiliation': 'University of Massachusetts Medical School.'}, {'ForeName': 'Lynley', 'Initials': 'L', 'LastName': 'Rappaport', 'Affiliation': 'University of Massachusetts Medical School.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Puerto', 'Affiliation': 'University of Massachusetts Medical School.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Dykhouse', 'Affiliation': 'University of Massachusetts Medical School.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Potts', 'Affiliation': 'University of Massachusetts Medical School.'}, {'ForeName': 'Andriana Foiles', 'Initials': 'AF', 'LastName': 'Sifuentes', 'Affiliation': 'University of Massachusetts Medical School.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Stanhope', 'Affiliation': 'University of Massachusetts Medical School.'}, {'ForeName': 'Jeroan', 'Initials': 'J', 'LastName': 'Allison', 'Affiliation': 'University of Massachusetts Medical School.'}, {'ForeName': 'Vennesa', 'Initials': 'V', 'LastName': 'Duodo', 'Affiliation': 'University of Massachusetts Medical School.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Sabin', 'Affiliation': 'University of Washington, Seattle, Washington, USA.'}]",Medicine,['10.1097/MD.0000000000023680'] 2172,33608319,Effect Modifiers of Low-Dose Tamoxifen in a Randomized Trial in Breast Noninvasive Disease.,"PURPOSE Low-dose tamoxifen halved recurrence after surgery in a phase III trial in breast noninvasive disease without increasing adverse events. We explored the effect of low-dose tamoxifen in clinically relevant subgroups, including menopausal status, estradiol levels, smoking, body mass index, and proliferation of baseline lesion. PATIENTS AND METHODS Incidence of invasive breast cancer or ductal carcinoma in situ was the primary endpoint. HRs and interaction terms were estimated using Cox models. RESULTS A favorable HR and 95% confidence interval (CI) could be demonstrated for postmenopausal status (HR = 0.30; 95% CI, 0.11-0.82 vs. HR = 0.73; 95% CI, 0.30-1.76 in premenopausal women; P interaction = 0.13), women with estradiol less than 15.8 pg/mL, presence of menopausal symptoms at baseline, and never smoking ( P interaction = 0.07), although the interaction P value was >0.05 for all characteristics. Efficacy was similar in all body mass index categories. Tumors with Ki-67 above the median level of 10% had a greater benefit (HR = 0.27; 95% CI, 0.09-0.81) than those with Ki-67 ≤10% (HR = 1.58; 95% CI, 0.45-5.60; P interaction = 0.04). CONCLUSIONS The efficacy of low-dose tamoxifen seems to be greater in postmenopausal women and in women with lower estradiol levels. Benefits appear to be larger also in women with menopausal symptoms, never smokers, and tumors with Ki-67 >10%. Our results by menopausal status provide important insight into low-dose tamoxifen personalized treatment, although caution is necessary given their exploratory nature. Observation of an improved response in tumors with Ki-67 >10% is consistent but the use of the marker in this setting is investigational.",2021,"Tumors with Ki-67 above the median level of 10% had a greater benefit (HR=0.27, 95% CI, 0.09, 0.81) than those with Ki-67 {less than or equal to}10% (HR=1.58, 95% CI, 0.45, 5.60, p-interaction=0.04). ","['breast non-invasive disease', 'postmenopausal women and in women with lower estradiol levels']",['tamoxifen'],"['Efficacy', 'menopausal status, estradiol levels, smoking, body mass index and proliferation of baseline lesion', 'postmenopausal status']","[{'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0860850', 'cui_str': 'Oestradiol decreased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0039286', 'cui_str': 'Tamoxifen'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0337434', 'cui_str': 'Estradiol measurement'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0334094', 'cui_str': 'Proliferation'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}]",,0.192859,"Tumors with Ki-67 above the median level of 10% had a greater benefit (HR=0.27, 95% CI, 0.09, 0.81) than those with Ki-67 {less than or equal to}10% (HR=1.58, 95% CI, 0.45, 5.60, p-interaction=0.04). ","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'DeCensi', 'Affiliation': 'E.O. Ospedali Galliera, Genoa, Italy. andrea.decensi@galliera.it.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Puntoni', 'Affiliation': 'E.O. Ospedali Galliera, Genoa, Italy.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Johansson', 'Affiliation': 'IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Aliana', 'Initials': 'A', 'LastName': 'Guerrieri-Gonzaga', 'Affiliation': 'IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Caviglia', 'Affiliation': 'E.O. Ospedali Galliera, Genoa, Italy.'}, {'ForeName': 'Franca', 'Initials': 'F', 'LastName': 'Avino', 'Affiliation': 'Istituto Nazionale Tumori ""Fondazione Pascale,"" Naples, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cortesi', 'Affiliation': 'A. O. Universitaria Policlinico di Modena, Modena, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ponti', 'Affiliation': 'CPO Piemonte, A.O.U. Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Pacquola', 'Affiliation': 'Ospedale SS Antonio e Margherita-ASL AL, Tortona, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Falcini', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.), Meldola, Italy.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Gulisano', 'Affiliation': 'ULSS 8 Vicenza, Vicenza, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Digennaro', 'Affiliation': 'Ospedale Oncologico di Bari - Istituto Tumori ""G. Paolo II,"" Bari, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Cariello', 'Affiliation': 'AUSL della Romagna, Ravenna, Italy.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Cagossi', 'Affiliation': 'Ospedale Bernardino Ramazzini, Carpi, Modena, Italy.'}, {'ForeName': 'Graziella', 'Initials': 'G', 'LastName': 'Pinotti', 'Affiliation': 'Asst Sette Laghi, Varese, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Lazzeroni', 'Affiliation': 'IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Serrano', 'Affiliation': 'IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Irene Maria', 'Initials': 'IM', 'LastName': 'Briata', 'Affiliation': 'E.O. Ospedali Galliera, Genoa, Italy.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Buttiron Webber', 'Affiliation': 'E.O. Ospedali Galliera, Genoa, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Boni', 'Affiliation': 'IRCCS Ospedale San Martino, Genova, Italy.'}, {'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Bonanni', 'Affiliation': 'IEO, European Institute of Oncology IRCCS, Milan, Italy.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-4213'] 2173,33607803,"The effect of the therapy of ""combination 3 methods progression"" in patients with neurogenic bowel dysfunction (constipated type): Study protocol for a randomized controlled trial.","BACKGROUND As one of the important manifestations of neurogenic bowel dysfunction, constipation is characterized by high incidence and harmful effects. It has a negative impact on both physical and psychological health of patients. And there are no effective treatment options for this type of disease clinically. Therefore, this study is designed to examine the effect of the therapy of ""combination 3 methods progression"" in patients with neurogenic bowel dysfunction (constipated type). METHODS This is a randomized, controlled, parallel-design clinical trial. A total of 60 patients with neurogenic bowel dysfunction (constipated type) will be randomly assigned to intervention group and control group. The control group will receive 4 weeks of usual rehabilitation care, the intervention group will receive 4 weeks of the therapy of ""combination 3 methods progression"" in addition to usual rehabilitation care. The primary outcome is the number of spontaneous bowel movement per week. Secondary outcomes are stool characteristics, degree of difficulty in defecation, level of anxiety, level of depression, and level of self-efficacy. DISCUSSION The interventions of this protocol have been programmed to alleviate constipation in patients with neurogenic bowel dysfunction. Findings may provide preliminary evidence for clinical efficacy of the therapy of ""combination 3 methods progression."" TRIAL REGISTRATION Chinese Clinical Trial Registry, IDF: ChiCTR2000041463. Registered on December 26, 2020.",2021,A total of 60 patients with neurogenic bowel dysfunction (constipated type) will be randomly assigned to intervention group and control group.,"['patients with neurogenic bowel dysfunction', 'patients with neurogenic bowel dysfunction (constipated type', '60 patients with neurogenic bowel dysfunction (constipated type']","['combination 3 methods progression', 'usual rehabilitation care, the intervention group will receive 4\u200aweeks of the therapy of ""combination 3 methods progression"" in addition to usual rehabilitation care']","['number of spontaneous bowel movement per week', 'stool characteristics, degree of difficulty in defecation, level of anxiety, level of depression, and level of self-efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0695242', 'cui_str': 'Neurogenic bowel'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",60.0,0.118068,A total of 60 patients with neurogenic bowel dysfunction (constipated type) will be randomly assigned to intervention group and control group.,"[{'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Nursing School, Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Yin-Li', 'Initials': 'YL', 'LastName': 'Shen', 'Affiliation': 'Department of Rehabilitation, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Yun-Lan', 'Initials': 'YL', 'LastName': 'Jiang', 'Affiliation': 'College of Clinical Medicine, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan Province, PR China.'}, {'ForeName': 'Dong-Shuang', 'Initials': 'DS', 'LastName': 'Li', 'Affiliation': 'Nursing School, Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Jin', 'Affiliation': 'Department of Rehabilitation, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine.'}]",Medicine,['10.1097/MD.0000000000024662'] 2174,33607802,Comparative effectiveness of furosemide vs torasemide in symptomatic therapy in heart failure patients: A randomized controlled study protocol.,,2021,,['heart failure patients'],['furosemide vs torasemide'],[],"[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0076840', 'cui_str': 'torsemide'}]",[],,0.0407024,,"[{'ForeName': 'Yifan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of cardiovascular surgery.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of critical care medicine, Shanxi Cardiovascular Hospital, Shanxi.'}, {'ForeName': 'Zhipeng', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': 'Department of cardiovascular surgery, TEDA International Cardiovascular Hospital, Tianjin, China.'}, {'ForeName': 'Shunye', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of cardiovascular surgery.'}]",Medicine,['10.1097/MD.0000000000024661'] 2175,33607792,Intraoperative periarticular injection can alleviate the inflammatory response and enhance joint function recovery after hip arthroplasty in elderly patients with osteoporotic femoral neck fractures.,"PURPOSE This study aimed to investigate the potential beneficial effects of periarticular injection (PAI) of multimodal drugs on the inflammatory response and joint function after hip arthroplasty in elderly patients with osteoporotic femoral neck fractures. METHODS Fifty six elderly patients with unilateral osteoporotic femoral neck fractures were randomly allocated to 2 groups: the PAI group, which received the multimodal drug PAI intraoperatively before incision closure, and the control group, which received an injection of saline at the same time as placebo. The C-reactive protein (CRP), interleukin-1β (IL-1β), and IL-6 levels as well as the erythrocyte sedimentation rate (ESR) in peripheral venous blood samples were measured, along with the Visual Analogue Scale (VAS) score with activity and Harris hip score preoperation at 1, 2, 4, 7, and 14 days as well as 1 and 3 months post-operation. RESULTS The 2 groups were comparable in sex and age, and no significant differences were observed in the preoperative CRP, IL-1β, and IL-6 levels, ESR, VAS score, or Harris hip score between the 2 groups (all P > .05). However, during the postoperative period, the PAI group exhibited significantly lower levels of CRP, IL-1β, and IL-6 as well as a lower ERS and VAS score compared with the control group (P < .05), while the Harris hip score was significantly higher postoperatively in the PAI group (P < .05). CONCLUSION Multimodal drug PAI can alleviate the inflammatory response and enhance hip function recovery after hip arthroplasty in elderly patients with osteoporotic femoral neck fractures.",2021,"The C-reactive protein (CRP), interleukin-1β (IL-1β), and IL-6 levels as well as the erythrocyte sedimentation rate (ESR) in peripheral venous blood samples were measured, along with the Visual Analogue Scale (VAS) score with activity and Harris hip score preoperation at 1, 2, 4, 7, and 14 days as well as 1 and 3 months post-operation. ","['elderly patients with osteoporotic femoral neck fractures', 'Fifty six elderly patients with unilateral osteoporotic femoral neck fractures']","['periarticular injection (PAI) of multimodal drugs', 'Intraoperative periarticular injection', 'placebo', 'multimodal drug PAI intraoperatively before incision closure, and the control group, which received an injection of saline']","['C-reactive protein (CRP), interleukin-1β (IL-1β), and IL-6 levels', 'inflammatory response and joint function', 'levels of CRP, IL-1β, and IL-6 as well as a lower ERS and VAS score', 'Harris hip score', 'preoperative CRP, IL-1β, and IL-6 levels, ESR, VAS score, or Harris hip score', 'erythrocyte sedimentation rate (ESR) in peripheral venous blood samples', 'Visual Analogue Scale (VAS) score with activity and Harris hip score preoperation']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015806', 'cui_str': 'Fracture of neck of femur'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0595695', 'cui_str': 'Periarticular route'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0542330', 'cui_str': 'Joint mobilization'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",56.0,0.0190487,"The C-reactive protein (CRP), interleukin-1β (IL-1β), and IL-6 levels as well as the erythrocyte sedimentation rate (ESR) in peripheral venous blood samples were measured, along with the Visual Analogue Scale (VAS) score with activity and Harris hip score preoperation at 1, 2, 4, 7, and 14 days as well as 1 and 3 months post-operation. ","[{'ForeName': 'Zhizheng', 'Initials': 'Z', 'LastName': 'Xiong', 'Affiliation': ""Department of Orthopaedics, Second People's Hospital of Yueyang.""}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Cao', 'Affiliation': ""Department of Orthopaedics, Second Affiliated Hospital of Medical College of Xi'an Jiaotong University, Xi'an, Shaanxi, PR China.""}, {'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': ""Department of Orthopaedics, Second People's Hospital of Yueyang.""}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopaedics, Second People's Hospital of Yueyang.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': ""Department of Orthopaedics, Second People's Hospital of Yueyang.""}, {'ForeName': 'Jinxi', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': ""Department of Orthopaedics, Second People's Hospital of Yueyang.""}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': ""Department of Orthopaedics, Second People's Hospital of Yueyang.""}, {'ForeName': 'Yongwei', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Orthopaedics, Second Affiliated Hospital of Medical College of Xi'an Jiaotong University, Xi'an, Shaanxi, PR China.""}]",Medicine,['10.1097/MD.0000000000024596'] 2176,33607790,The efficacy and safety of auricular acupuncture versus electroacupuncture in ameliorating chemotherapy-induced nausea and vomiting among patients receiving cisplatin-based regimens.,"BACKGROUND Nausea and vomiting are among the most common and distressing side effects of chemotherapy. Difference in views about the effectiveness of auricular acupuncture (AA) versus electroacupuncture (EA) of chemotherapy-induced nausea and vomiting (CINV) lies at the heart of the debate. The aim of this study is to compare the antiemetic efficacy and safety of AA and EA for CINV. METHODS One hundred twenty participants, 18 to 75 years old malignant tumors will receiving chemotherapy with cisplatin, will be recruited and randomized into 3 groups equally, Group A (the AA group), Group B (the EA group), and Group C (the control group). The participants in Group A and Group B will receive AA or EA regimens, alternatively, beginning on the day before first day of chemotherapy for a third consecutive cycles. All participants will continue to receive conventional treatment. The incidence and severity of CINV will be assessed using the definition and classification of nausea and vomiting (NCI-CTC AE4.0) and the MASCC (Multinational Association for Supportive Care in Cancer) Antiemesis Tool (MAT). Secondary outcome measures include the degree of abdominal distension, the first time of flatus and defecation, and life quality. Additionally, adverse events will also be documented during the period of the treatment. DISCUSSION This trial may provide evidence regarding the clinical effectiveness and safety of AA versus EA for CINV following cisplatin-based regimens. TRAIL REGISTRATION This study is registered with the Chinese Clinical Trial Registry: ChiCTR2000040942.",2021,Difference in views about the effectiveness of auricular acupuncture (AA) versus electroacupuncture (EA) of chemotherapy-induced nausea and vomiting (CINV) lies at the heart of the debate.,"['One hundred twenty participants', 'patients receiving cisplatin-based regimens', 'Cancer', '18 to 75\u200ayears old malignant tumors will receiving']","['auricular acupuncture versus electroacupuncture', 'chemotherapy with cisplatin', 'auricular acupuncture (AA) versus electroacupuncture (EA']","['nausea and vomiting', 'nausea and vomiting (CINV', 'degree of abdominal distension, the first time of flatus and defecation, and life quality', 'antiemetic efficacy and safety', 'efficacy and safety', 'adverse events']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0752217', 'cui_str': 'Ear Acupuncture'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0401160', 'cui_str': 'Chemotherapy-induced nausea and vomiting'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",120.0,0.0794282,Difference in views about the effectiveness of auricular acupuncture (AA) versus electroacupuncture (EA) of chemotherapy-induced nausea and vomiting (CINV) lies at the heart of the debate.,"[{'ForeName': 'Meng-Yue', 'Initials': 'MY', 'LastName': 'Liu', 'Affiliation': 'Department of Traditional Chinese Medicine.'}, {'ForeName': 'Lai', 'Initials': 'L', 'LastName': 'Sung', 'Affiliation': ""Oncology Department, Chengdu Second People's Hospital.""}, {'ForeName': 'Yan-Sen', 'Initials': 'YS', 'LastName': 'Liao', 'Affiliation': ""Oncology Department, Chengdu Second People's Hospital.""}, {'ForeName': 'Yi-Fei', 'Initials': 'YF', 'LastName': 'Jiao', 'Affiliation': ""Department of Traditional Chinese Medicine, Chengdu Seventh People's Hospital, Chengdu, Sichuan Province, P.R. China.""}, {'ForeName': 'Chang-Sheng', 'Initials': 'CS', 'LastName': 'Sun', 'Affiliation': 'Department of Traditional Chinese Medicine.'}, {'ForeName': 'Xiao-Dong', 'Initials': 'XD', 'LastName': 'Peng', 'Affiliation': ""Oncology Department, Chengdu Second People's Hospital.""}]",Medicine,['10.1097/MD.0000000000024588'] 2177,33607775,Efficacy and safety of Shenfu injection combined with sodium nitroprusside in the treatment of chronic heart failure in patients with coronary heart disease: A protocol of randomized controlled trial.,"BACKGROUND Coronary heart disease is a serious cardiovascular disease. There is coronary atherosclerosis, resulting in lumen stenosis, blockage, and then the symptoms of insufficient blood supply and hypoxia in the myocardium. Chronic heart failure is a kind of syndrome with abnormal ventricular filling and ejection function, which is the final stage of the development of coronary heart disease. At present, the treatment plan of Western medicine can significantly reduce the hospitalization rate, but it is still not satisfactory for the prognosis and mortality of patients. Shenfu injection has advantages in the treatment of heart failure in patients with coronary heart disease, but there is a lack of standard clinical studies to verify it, so the purpose of this randomized controlled study is to evaluate the efficacy and safety of Shenfu injection combined with sodium nitroprusside in the treatment of chronic heart failure in patients with coronary heart disease. METHODS This is a prospective randomized controlled trial to study the efficacy and safety of Shenfu injection combined with sodium nitroprusside in the treatment of chronic heart failure in patients with coronary heart disease. The patients will be randomly divided into a treatment group and the control group according to 1:1, in which the treatment group is treated with Shenfu injection combined with sodium nitroprusside, and the control group is treated with sodium nitroprusside alone. Both groups will be treated with standard treatment for 7 days and followed up for 30 days to pay attention to their efficacy and safety indexes. The observation indexes include TCM syndrome score, N-terminal pro-brain natriuretic peptide, left ventricular ejection fraction, brain natriuretic peptide, left ventricular end-systolic diameter, left ventricular end-diastolic diameter, stroke volume, adverse reactions and so on. We will use SPSS 25.0 software for data analysis. DISCUSSION This study will evaluate the efficacy and safety of Shenfu injection combined with sodium nitroprusside in the treatment of chronic heart failure in patients with coronary heart disease. The results of this experiment will provide a clinical basis for Shenfu injection combined with sodium nitroprusside in the treatment of chronic heart failure in coronary heart disease. TRIAL REGISTRATION DOI 10.17605/OSF.IO/4KNG3.",2021,"At present, the treatment plan of Western medicine can significantly reduce the hospitalization rate, but it is still not satisfactory for the prognosis and mortality of patients.",['patients with coronary heart disease'],"['Shenfu injection combined with sodium nitroprusside', 'sodium nitroprusside alone', 'Shenfu injection', 'sodium nitroprusside']","['chronic heart failure', 'Efficacy and safety', 'hospitalization rate', 'efficacy and safety', 'TCM syndrome score, N-terminal pro-brain natriuretic peptide, left ventricular ejection fraction, brain natriuretic peptide, left ventricular end-systolic diameter, left ventricular end-diastolic diameter, stroke volume, adverse reactions and so on']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C1528398', 'cui_str': 'Shen-Fu'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0037533', 'cui_str': 'Sodium nitroprusside'}]","[{'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",,0.0324013,"At present, the treatment plan of Western medicine can significantly reduce the hospitalization rate, but it is still not satisfactory for the prognosis and mortality of patients.","[{'ForeName': 'Binbin', 'Initials': 'B', 'LastName': 'Guo', 'Affiliation': 'Department of Clinical Medicine, Jiangxi Health Vocational College of China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': 'Department of Clinical Medicine, Jiangxi Health Vocational College of China.'}, {'ForeName': 'Jinniang', 'Initials': 'J', 'LastName': 'Nan', 'Affiliation': 'Department of Clinical Medicine, Jiangxi Health Vocational College of China.'}, {'ForeName': 'Qianghui', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Second Affiliated Hospital of Nanchang University.'}, {'ForeName': 'Chenxiu', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""Jiangxi Provincial People's Hospital.""}, {'ForeName': 'Wenpeng', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Jiangxi Provincial Traditional Chinese Medical Hospital, Nanchang, Jiangxi Province, China.'}]",Medicine,['10.1097/MD.0000000000024414'] 2178,33606922,"First-in-Human Study for a Selective Rearranged During Transfection Tyrosine Kinase Inhibitor, GSK3352589, to Investigate the Safety, Tolerability, and Pharmacokinetics in Healthy Volunteers.","Rearranged during transfection (RET), a neuronal growth factor receptor tyrosine kinase, regulates the development of sympathetic, parasympathetic, motor, and sensory neurons in the enteric nervous system. The intended site of action for GSK3352589 is intestinal tissues. GSK3352589 is an RET kinase inhibitor that was administered in double-blind, randomized, placebo-controlled single-dose (SD) and repeat-dose (RD) studies in healthy subjects to investigate its safety/tolerability and pharmacokinetics. In the SD study (n = 28), GSK3352589 was dosed from 2 to 400 mg, including a food effect arm (25 mg). In the RD study (n = 40), GSK3352589 was dosed for 14 days with food twice daily from 5 to 200 mg. With single (fed and fasted) and repeat (fed) doses, bioavailability was low and less than dose-proportional. There was a food effect with 25 mg once daily but may not be clinically relevant. Elimination half-life was ≥17 hours at SD ≥ 15 mg. Accumulation ratios for C max , AUC t , AUC tau , and AUC 24 after twice-daily dosing to steady state ranged from 1.2 to 1.8 for all doses except the 200-mg dose, which had ratios between 1.9 and 2.7. Administration of GSK3352589 after SD and RD was well tolerated with no safety concerns in healthy subjects.",2021,Administration of GSK3352589 after SD and RD was well tolerated with no safety concerns in healthy subjects.,"['healthy subjects', 'Healthy Volunteers']","['placebo', 'GSK3352589']","['Accumulation ratios for C max , AUC t , AUC tau , and AUC 24 after twice-daily dosing to steady state', 'bioavailability', 'safety/tolerability and pharmacokinetics', 'Safety, Tolerability, and Pharmacokinetics']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",,0.130064,Administration of GSK3352589 after SD and RD was well tolerated with no safety concerns in healthy subjects.,"[{'ForeName': 'Beth Ann', 'Initials': 'BA', 'LastName': 'Reedy', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': ""O'Connor-Semmes"", 'Affiliation': 'Parexel International, CPMS, Durham, USA.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Hacquoil', 'Affiliation': 'Clinical Statistics, GlaxoSmithKline, Stevenage, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gorycki', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Adeline', 'Initials': 'A', 'LastName': 'Verticelli', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Molga', 'Affiliation': 'CMAX Clinical Research Pty Ltd, Adelaide, Australia.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.911'] 2179,33610123,Cediranib in addition to chemotherapy for women with relapsed platinum-sensitive ovarian cancer (ICON6): overall survival results of a phase III randomised trial.,"BACKGROUND Cediranib, an oral anti-angiogenic VEGFR 1-3 inhibitor, was studied at a daily dose of 20 mg in combination with platinum-based chemotherapy and as maintenance in a randomised trial in patients with first relapse of 'platinum-sensitive' ovarian cancer and has been shown to improve progression-free survival (PFS). PATIENTS AND METHODS ICON6 (NCT00532194) was an international three-arm, double-blind, placebo-controlled randomised trial. Between December 2007 and December 2011, 456 women were randomised, using stratification, to receive either chemotherapy with placebo throughout (arm A, reference); chemotherapy with concurrent cediranib, followed by maintenance placebo (arm B, concurrent); or chemotherapy with concurrent cediranib, followed by maintenance cediranib (arm C, maintenance). Due to an enforced redesign of the trial in September 2011, the primary endpoint became PFS between arms A and C which we have previously published, and the overall survival (OS) was defined as a secondary endpoint, which is reported here. RESULTS After a median follow-up of 25.6 months, strong evidence of an effect of concurrent plus maintenance cediranib on PFS was observed [hazard ratio (HR) 0.56, 95% confidence interval (CI) 0.44-0.72, P < 0.0001]. In this final update of the survival analysis, 90% of patients have died. There was a 7.4-month difference in median survival and an HR of 0.86 (95% CI: 0.67-1.11, P = 0.24) in favour of arm C. There was strong evidence of a departure from the assumption of non-proportionality using the Grambsch-Therneau test (P = 0.0031), making the HR difficult to interpret. Consequently, the restricted mean survival time (RMST) was used and the estimated difference over 6 years by the RMST was 4.8 months (95% CI: -0.09 to 9.74 months). CONCLUSIONS Although a statistically significant difference in time to progression was seen, the enforced curtailment in recruitment meant that the secondary analysis of OS was underpowered. The relative reduction in the risk of death of 14% risk of death was not conventionally statistically significant, but this improvement and the increase in the mean survival time in this analysis suggest that cediranib may have worthwhile activity in the treatment of recurrent ovarian cancer and that further research should be undertaken.",2021,"The relative reduction in the risk of death of 14% risk of death was not conventionally statistically significant, but this improvement and the increase in the mean survival time in this analysis suggest that cediranib may have worthwhile activity in the treatment of recurrent ovarian cancer and that further research should be undertaken.","[""patients with first relapse of 'platinum-sensitive' ovarian cancer"", 'Between December 2007 and December 2011, 456 women', 'women with relapsed platinum-sensitive ovarian cancer (ICON6']","['placebo', 'chemotherapy with concurrent cediranib, followed by maintenance placebo (arm B, concurrent); or chemotherapy with concurrent cediranib, followed by maintenance cediranib', 'chemotherapy with placebo', 'chemotherapy', 'platinum-based chemotherapy', 'cediranib', 'Cediranib']","['time to progression', 'overall survival (OS', 'median survival', 'mean survival time (RMST', 'hazard ratio (HR', 'mean survival time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C1698364', 'cui_str': 'cediranib'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0086595', 'cui_str': 'Mean Survival Time'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",456.0,0.635554,"The relative reduction in the risk of death of 14% risk of death was not conventionally statistically significant, but this improvement and the increase in the mean survival time in this analysis suggest that cediranib may have worthwhile activity in the treatment of recurrent ovarian cancer and that further research should be undertaken.","[{'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Ledermann', 'Affiliation': 'UCL Cancer Institute, Cancer Research UK & UCL Trials Centre, London, UK. Electronic address: j.ledermann@ucl.ac.uk.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Embleton-Thirsk', 'Affiliation': 'UCL Comprehensive Clinical Trials Unit, London, UK.'}, {'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'Perren', 'Affiliation': ""Leeds Institute of Medical Research at St James's, Leeds, UK.""}, {'ForeName': 'G C', 'Initials': 'GC', 'LastName': 'Jayson', 'Affiliation': 'Christie Hospital and University of Manchester, Manchester, UK.'}, {'ForeName': 'G J S', 'Initials': 'GJS', 'LastName': 'Rustin', 'Affiliation': 'Mount Vernon Cancer Centre, London, UK.'}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Kaye', 'Affiliation': 'Royal Marsden Hospital, London, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hirte', 'Affiliation': 'Juravinski Cancer Centre, Hamilton, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Oza', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Vaughan', 'Affiliation': 'Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Friedlander', 'Affiliation': 'Prince of Wales Clinical School, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'González-Martín', 'Affiliation': 'Clínica Universidad de Navarra, Madrid, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Deane', 'Affiliation': 'UCL Comprehensive Clinical Trials Unit, London, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Popoola', 'Affiliation': 'Medical Research Council Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Farrelly', 'Affiliation': 'UCL Cancer Institute, Cancer Research UK & UCL Trials Centre, London, UK.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Swart', 'Affiliation': 'University of East Anglia, Norwich, UK.'}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Kaplan', 'Affiliation': 'Medical Research Council Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': 'M K B', 'Initials': 'MKB', 'LastName': 'Parmar', 'Affiliation': 'Medical Research Council Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",ESMO open,['10.1016/j.esmoop.2020.100043'] 2180,33610094,Modafinil reduces smoked cocaine self-administration in humans: effects vary as a function of cocaine 'priming' and cost.,"BACKGROUND The absence of an FDA-approved medication for the treatment of cocaine use disorder (CUD) may, in part, reflect the varying conditions present when the decision to use cocaine is made, with one medication unlikely to work under all conditions. The objective of this double-blind, placebo-controlled, human laboratory study was to test the effects of modafinil, a medication with mixed efficacy for the treatment of CUD, using a novel self-administration procedure designed to model distinct clinical scenarios. METHODS During modafinil maintenance (0, 300 mg/day), participants chose to self-administer up to 7 doses of smoked cocaine (25 mg) under 9 conditions: immediately after exposure to: (a) cues associated with cocaine and a non-contingent cocaine administration, i.e. 'prime' (25 mg), (b) only cocaine cues, and (c) neither cues nor cocaine. Each condition was tested when self-administered cocaine cost $5, $10 and $15/dose. RESULTS Nontreatment-seeking cocaine smokers (3 F,13 M), spending $388 ± 218/week on cocaine and with no history of alcohol use disorder, completed the study. Relative to placebo, modafinil robustly attenuated self-administration when cocaine was expensive ($10,$15/dose) and when there was no 'prime.' Modafinil had no effect on self-administration when cocaine was inexpensive ($5/dose) or when participants received a 'prime.' CONCLUSIONS Modafinil's effects on cocaine-taking varied substantially as a function of recent cocaine exposure and cost, which may help explain the mixed clinical findings. Modafinil may be most effective for preventing relapse in abstinent patients, particularly under conditions in which cocaine is costly, rather than initiating abstinence for those continuing to use cocaine.",2021,"Relative to placebo, modafinil robustly attenuated self-administration when cocaine was expensive ($10,$15/dose) and when there was no 'prime.'","['smoked cocaine self-administration in humans', 'abstinent patients', 'Nontreatment-seeking cocaine smokers (3\u2009F,13\u2009M), spending $388\u2009±\u2009218/week on']","['Modafinil', 'placebo', ""smoked cocaine (25\u2009mg) under 9 conditions: immediately after exposure to: (a) cues associated with cocaine and a non-contingent cocaine administration, i.e. 'prime' (25\u2009mg), (b) only cocaine cues, and (c) neither cues nor cocaine"", 'placebo, modafinil', 'modafinil maintenance', 'modafinil', 'cocaine']",[],"[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0036589', 'cui_str': 'Self-administration of medication'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0066677', 'cui_str': 'modafinil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0071973', 'cui_str': 'PRIME protocol'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",[],,0.0245067,"Relative to placebo, modafinil robustly attenuated self-administration when cocaine was expensive ($10,$15/dose) and when there was no 'prime.'","[{'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Haney', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center and the New York State Psychiatric Institute, USA. Electronic address: mh235@cumc.columbia.edu.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Rubin', 'Affiliation': 'Department of Psychiatry, Harlem Hospital Center, Columbia University College of Physicians and Surgeons, USA.'}, {'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Denson', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center and the New York State Psychiatric Institute, USA.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Foltin', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center and the New York State Psychiatric Institute, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.108554'] 2181,33555830,Oral Contraceptives Do Not Affect Physiological Responses to Strength Exercise.,"ABSTRACT Umlauff, L, Weil, P, Zimmer, P, Hackney, AC, Bloch, W, and Schumann, M. Oral contraceptives do not affect physiological responses to strength exercise. J Strength Cond Res 35(4): 894-901, 2021-This study investigated the effect of oral contraceptive (OC) use on acute changes in steroid hormone concentrations and tryptophan (TRP) metabolites in response to strength exercise. Twenty-one women (age: 23 ± 3 years), 8 combined OC users (OC group) and 13 naturally cycling women (menstrual cycle [MC] group), participated. Testing was performed during the pill-free interval for the OC group and the follicular phase for the MC group. Subjects completed an intense strength exercise protocol (4 × 10 repetitions back squat). Blood samples were taken at baseline (T0), post-exercise (T1), and after 24 hours (T2) to determine serum concentrations of cortisol, estradiol, testosterone, TRP, and kynurenine (KYN). Statistical significance was defined as p ≤ 0.05. At T0, the OC group showed higher cortisol (OC: 493.7 ± 47.1 ng·mL-1, MC: 299.1 ± 62.7 ng·mL-1, p < 0.001) and blood lactate (OC: 1.81 ± 0.61 mmol·L-1, MC: 1.06 ± 0.30 mmol·L-1, p = 0.001) and lower estradiol (OC: 31.12 ± 4.24 pg·mL-1, MC: 38.34 ± 7.50 pg·mL-1, p = 0.023) and KYN (OC: 1.15 ± 0.23 µmol·L-1, MC: 1.75 ± 0.50 µmol·L-1, p = 0.005). No significant interactions (group × time, p > 0.05) were found for the hormones and TRP metabolites assessed. Oral contraceptive use did not affect the physiological response of steroid hormones and TRP metabolites to acute strength exercise during the low hormone phase of the contraceptive or MC in healthy young women, even when some baseline concentrations differed between groups. Consequently, these findings provide important implications for practitioners testing heterogeneous groups of female athletes.",2021,"Oral contraceptive use did not affect the physiological response of steroid hormones and TRP metabolites to acute strength exercise during the low hormone phase of the contraceptive or MC in healthy young women, even when some baseline concentrations differed between groups.","['practitioners testing heterogeneous groups of female athletes', 'Twenty-one women (age: 23 ± 3 years), 8 combined OC users (OC group) and 13 naturally cycling women (menstrual cycle [MC] group), participated', ' 000-000', 'healthy young women']","['intense strength exercise protocol', 'oral contraceptive (OC', 'J Strength Cond Res XX(X']","['blood lactate', 'serum concentrations of cortisol, estradiol, testosterone, TRP, and kynurenine (KYN']","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0242960', 'cui_str': 'Heterogeneity, Genetic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009906', 'cui_str': 'Oral Contraceptives, Combined'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0022818', 'cui_str': 'Kynurenine'}]",,0.0299249,"Oral contraceptive use did not affect the physiological response of steroid hormones and TRP metabolites to acute strength exercise during the low hormone phase of the contraceptive or MC in healthy young women, even when some baseline concentrations differed between groups.","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Umlauff', 'Affiliation': 'Department for Molecular and Cellular Sports Medicine, Institute of Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Weil', 'Affiliation': 'Department for Molecular and Cellular Sports Medicine, Institute of Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Zimmer', 'Affiliation': 'Department of Performance and Health (Sports Medicine), Institute of Sport and Sport Science, Technical University Dortmund, Dortmund, Germany; and.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Hackney', 'Affiliation': 'Department of Exercise & Sport Science, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Bloch', 'Affiliation': 'Department for Molecular and Cellular Sports Medicine, Institute of Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Schumann', 'Affiliation': 'Department for Molecular and Cellular Sports Medicine, Institute of Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003958'] 2182,33563040,Quality-adjusted survival in patients with metastatic colorectal cancer treated with fruquintinib in the FRESCO trial.,"Aim: To assess whether the survival benefit of fruquintinib is quality-adjusted. Materials & methods: Data of 416 metastatic colorectal cancer patients from the Phase III FRESCO trial were used. The Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST) analysis assessed the quality-adjusted survival benefit of fruquintinib versus placebo, accounting for freedom from symptomatic disease and from severe side effects of treatment. Results: Fruquintinib significantly improved patients' Q-TWiST (difference: 2.23 [1.41, 3.04] months) versus placebo. The Q-TWiST gain was 28.3% in the base case and ranged from 16.7 to 39.9% in the threshold analysis, favoring fruquintinib. The Q-TWiST benefit was observed in fruquintinib-treated patients regardless of prior targeted therapy. Conclusion: Fruquintinib provides a clinically meaningful quality-adjusted survival benefit versus placebo as a third-line treatment for metastatic colorectal cancer patients.",2021,"significantly improved patients' Q-TWiST (difference: 2.23 [1.41, 3.04] months) versus placebo.","['416 metastatic colorectal cancer\xa0patients from the Phase III FRESCO trial were used', 'patients with metastatic colorectal cancer treated with fruquintinib in FRESCO trial', 'metastatic colorectal cancer patients']",['placebo'],"['Q-TWiST gain', 'Q-TWiST benefit', 'quality-adjusted survival benefit', 'Quality-adjusted survival', 'Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST']","[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040480', 'cui_str': 'Torsion'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",416.0,0.343916,"significantly improved patients' Q-TWiST (difference: 2.23 [1.41, 3.04] months) versus placebo.","[{'ForeName': 'Shukui', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': 'Department of Medical Oncology, Cancer Center of Jinling Hospital, Nanjing, 210029, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Tongji University East Hospital, Department of Medical Oncology, Shanghai, 200120, China.'}, {'ForeName': 'Yuxian', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Harbin Medical University Cancer Hospital, Department of Medical Oncology, Harbin, 120081, China.'}, {'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Department of Medical Oncology, The Sixth Hospital Affiliated to Sun Yat-Sen University, Guangzhou, 510655, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Nantong Tumor Hospital, Department of medical oncology, Nantong, 226361, China.'}, {'ForeName': 'Rui-Hua', 'Initials': 'RH', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, Sun Yat-Sen University, Guangzhou, 510080, China.'}, {'ForeName': 'Haijun', 'Initials': 'H', 'LastName': 'Zhong', 'Affiliation': 'Zhejiang Cancer Hospital, Department of Medical Oncology, Hangzhou, 310022, China.'}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Second Hospital of Anhui Medical University, Department of Medical Oncology, Hefei, 230601, China.'}, {'ForeName': 'Hongming', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': 'Sir Run Run Shaw Hospital, Department of Medical Oncology, Hangzhou, 310020, China.'}, {'ForeName': 'Weijian', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai Medical College, Department of Medical Oncology, Shanghai, 200032, China.'}, {'ForeName': 'Yongqian', 'Initials': 'Y', 'LastName': 'Shu', 'Affiliation': 'Jiangsu Provincial Hospital, Department of Medical Oncology, Nanjing, 210029, China.'}, {'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': '307th Hospital of Chinese PLA-The Affiliated Hospital of Military Medical Sciences, Department of Medical Oncology, Beijing, 100071, China.'}, {'ForeName': 'Cike', 'Initials': 'C', 'LastName': 'Peng', 'Affiliation': 'Eli Lilly & Company China Affiliate, Lilly China Drug Development & Medical Affairs Center, Shanghai, 200041, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Eli Lilly & Company China Affiliate, Lilly China Drug Development & Medical Affairs Center, Shanghai, 200041, China.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Eli Lilly & Company China Affiliate, Lilly China Drug Development & Medical Affairs Center, Shanghai, 200041, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Eli Lilly & Company China Affiliate, Lilly China Drug Development & Medical Affairs Center, Shanghai, 200041, China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Hutchison MediPharma Ltd, Shanghai, 201203, China.'}, {'ForeName': 'Mengye', 'Initials': 'M', 'LastName': 'Peng', 'Affiliation': 'Hutchison MediPharma Ltd, Shanghai, 201203, China.'}, {'ForeName': 'Songhua', 'Initials': 'S', 'LastName': 'Fan', 'Affiliation': 'Hutchison MediPharma Ltd, Shanghai, 201203, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis & Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, 100048, China.'}]","Future oncology (London, England)",['10.2217/fon-2020-1215'] 2183,33561724,Preoperative Tamsulosin to Prevent Postoperative Urinary Retention: A Randomized Controlled Trial.,"BACKGROUND The purpose of this study was to evaluate the efficacy of tamsulosin, administered preoperatively, for the prevention of postoperative urinary retention (POUR). POUR is a common complication of abdominal surgery, leading to the use of urinary catheters, which are a risk factor for urinary tract infection. Tamsulosin is a uroselective alpha-1a blocker used for the treatment of lower urinary tract symptoms. MATERIALS AND METHODS A randomized, double-blind, placebo-controlled trial was undertaken from August 2015 to May 2018. Adults undergoing elective inpatient abdominal surgery were randomized to receive either tamsulosin 0.4 mg or placebo daily for 7 d before surgery and continuing for up to 7 d postoperatively. The primary outcome was need for at least a single intermittent catheterization postoperatively. Secondary outcomes included first postvoid residual volume, number of catheterizations, need for replacement of an indwelling catheter, hospital length of stay, and urinary tract infection within 30 d of surgery. RESULTS A total of 158 participants were enrolled, with a final analytic cohort of 141 participants. The two groups had similar baseline characteristics, operative characteristics, and timing of catheter removal. There was no difference in the incidence of POUR between the two groups (26% in tamsulosin versus 31% in placebo, P = 0.49). There was also no difference in any of the secondary outcomes between the two groups. Epidural usage, open surgery, and age <50 were identified as risk factors for POUR. CONCLUSIONS Perioperative prophylaxis with tamsulosin is not effective in reducing the incidence of POUR in patients undergoing elective abdominal surgery.",2021,"CONCLUSIONS Perioperative prophylaxis with tamsulosin is not effective in reducing the incidence of POUR in patients undergoing elective abdominal surgery.","['Adults undergoing elective inpatient abdominal surgery', 'August 2015 to May 2018', 'patients undergoing elective abdominal surgery', '158 participants were enrolled, with a final analytic cohort of 141 participants']","['tamsulosin', 'tamsulosin 0.4\xa0mg or placebo', 'placebo', 'Preoperative Tamsulosin', 'Tamsulosin']","['need for at least a single intermittent catheterization postoperatively', 'Postoperative Urinary Retention', 'operative characteristics, and timing of catheter removal', 'incidence of POUR', 'postoperative urinary retention (POUR', 'first postvoid residual volume, number of catheterizations, need for replacement of an indwelling catheter, hospital length of stay, and urinary tract infection within 30\xa0d of surgery']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C4517572', 'cui_str': '141'}]","[{'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0394884', 'cui_str': 'Removal of catheter'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0007439', 'cui_str': 'In-Dwelling Catheters'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",158.0,0.345461,"CONCLUSIONS Perioperative prophylaxis with tamsulosin is not effective in reducing the incidence of POUR in patients undergoing elective abdominal surgery.","[{'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Papageorge', 'Affiliation': 'Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Bailey', 'Initials': 'B', 'LastName': 'Howington', 'Affiliation': 'Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Leverson', 'Affiliation': 'Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Kennedy', 'Affiliation': 'Department of Surgery, University of Alabama-Birmingham, Gardendale, Alabama.'}, {'ForeName': 'Evie H', 'Initials': 'EH', 'LastName': 'Carchman', 'Affiliation': 'Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin. Electronic address: carchman@surgery.wisc.edu.'}]",The Journal of surgical research,['10.1016/j.jss.2020.12.055'] 2184,33823783,Response to a sexual risk reduction intervention provided in combination with hepatitis C treatment by HIV/HCV co-infected men who have sex with men: a reflexive thematic analysis.,"BACKGROUND Hepatitis C virus reinfections in HIV-positive men-who-have-sex-with-men (MSM) challenge the effectiveness of antiviral treatment. To fight this problem, an adapted sexual risk reduction intervention was implemented within a hepatitis C treatment trial. Following this, the current study had two aims and describes 1) how the program was received by participants; and 2) their responses to the program regarding sexual risk taking. Based on the participants' input, we hoped to judge the intervention's potential for scale-up. METHODS Seventeen participants who received the sexual risk reduction intervention in addition to hepatitis C treatment were recruited for semi-structured interviews six to 12 months post-intervention. We evaluated the responses via reflexive thematic analysis and applied the concept of sense-making. RESULTS Giving hepatitis C a place and living without it again illustrates how participants received the program and how their experiences were altered by the impact of sense-making. Based on their responses, we allocated participants to three groups: 1. Avoid risks: get rid of hepatitis C for life. For these men, hepatitis C remained a life-threatening disease: they actively modified their risk behavior and felt supported by the intervention in maintaining their behavioral changes. 2. Minimize risks: live as long as possible without hepatitis C. In contrast to group 1, these men saw hepatitis C as a manageable disease. The intervention facilitated reflection on risks and how to develop behavioral changes that suited them individually. 3. Accept risks; live with the risk of hepatitis C. These men perceived behavioral changes as much more difficult than ""easy"" medical treatment. They expected to either undergo repeated rounds of treatment or stay HCV re-infected. CONCLUSION These results illustrate the diversity of men's responses and their decisions regarding sexual risk behavior after participating in a combination of antiviral treatment and a sexual risk reduction intervention. Two major aspects were identified: 1) Teachable moments, particularly at the time of diagnosis/treatment, could offer an opportunity to develop openness for behavioral change; 2) adapting sexual risk reduction interventions to sense-making patterns could help to improve its effectiveness. Support for reducing infection risk and raising awareness of preventative measures are additional benefits. TRIAL REGISTRATION Clinical Trial Number: NCT02785666 , 30.05.2016.",2021,"For these men, hepatitis C remained a life-threatening disease: they actively modified their risk behavior and felt supported by the intervention in maintaining their behavioral changes.","['infected men who have sex with men', 'Seventeen participants who received the sexual risk reduction intervention in addition to hepatitis C treatment were recruited for semi-structured interviews six to 12 months post-intervention', 'HIV-positive men-who-have-sex-with-men (MSM']",['sexual risk reduction intervention provided in combination with hepatitis C treatment by HIV/HCV co'],['sexual risk behavior'],"[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0058231', 'cui_str': 'methylsulfonylmethane'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}]",17.0,0.0261181,"For these men, hepatitis C remained a life-threatening disease: they actively modified their risk behavior and felt supported by the intervention in maintaining their behavioral changes.","[{'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Künzler-Heule', 'Affiliation': 'Nursing Science, Department Public Health, Medical Faculty, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Fierz', 'Affiliation': 'Zurich University of Applied Sciences (ZUAS), Winterthur, Switzerland.'}, {'ForeName': 'Axel Jeremias', 'Initials': 'AJ', 'LastName': 'Schmidt', 'Affiliation': 'Division of Infectious Diseases, Cantonal Hospital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Rasi', 'Affiliation': 'Department of Public & Global Health, Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Jasmina', 'Initials': 'J', 'LastName': 'Bogdanovic', 'Affiliation': 'Nursing Science, Department Public Health, Medical Faculty, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Kocher', 'Affiliation': 'Nursing Science, Department Public Health, Medical Faculty, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Engberg', 'Affiliation': 'Nursing Science, Department Public Health, Medical Faculty, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Battegay', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Christiana', 'Initials': 'C', 'LastName': 'Nöstlinger', 'Affiliation': 'Institute of Tropical Medicine, Department of Public Health, Antwerp, Belgium.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Lehner', 'Affiliation': 'AIDS-Hilfe Schweiz, Zurich, Switzerland.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Kouyos', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schmid', 'Affiliation': 'Division of Infectious Diseases, Cantonal Hospital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Dominique Laurent', 'Initials': 'DL', 'LastName': 'Braun', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Fehr', 'Affiliation': 'Department of Public & Global Health, Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Dunja', 'Initials': 'D', 'LastName': 'Nicca', 'Affiliation': 'Nursing Science, Department Public Health, Medical Faculty, University of Basel, Basel, Switzerland. dunja.nicca@unibas.ch.'}]",BMC infectious diseases,['10.1186/s12879-021-06003-z'] 2185,33567005,Use of computerized campimetry and/or optical coherence tomography for glaucoma diagnosis by non-glaucoma specialists.,"PURPOSE To compare the use of visual field and/or optical coherence tomography (OCT) combined with color retinography by non-glaucoma specialists for differentiating glaucoma from physiological cupping. METHODS Eighty patients with glaucoma or physiological cupping (40 of each) were randomized according to the examination used (GI: color retinography, GII: color retinography + visual field, GIII: color retinography + optical coherence tomography, GIV: color retinography + visual field + optical coherence tomography). Twenty non-specialist ophthalmologists diagnosed glaucoma from PowerPoint slide images, without direct patient examination. RESULTS Inter-examiner agreement was good for GII (ĸ: 0.63; 95%CI, 0.53-0.72), moderate for GIII (ĸ: 0.58; 95%CI, 0.48-0.68) and GIV (ĸ: 0.41; 95%CI, 0.31-0.51), and low for GI (ĸ: 0.30; 95%CI, 0.20-0.39) (p<0.001). Diagnostic accuracy was higher in GIII (15.8 ± 1.82) than GI (12.95 ± 1.46, p<0.001) and higher in GII (16.25 ± 2.02) than GI and GIV (14.10 ± 2.24) (both p<0.001). For glaucoma patients only, diagnostic accuracy in GII and GIII was superior to that in GI and GIV (both p<0.001). Sensitivity and specificity were 59% and 70.5% in GI; 86.5% and 76% in GII, 86.5% and 71.5% in GIII; and 68.5% and 72.5% in GIV, respectively. Accuracy was highest in GII (81.3% [95%CI, 77.1-84.8]), followed by GIII (79% [95%CI, 74.7-82.7]), GIV (70,5% [95%CI, 65.9-74.8]), and GI (64.8% [95%CI, 60.0-69.3]). CONCLUSIONS Non-glaucoma specialists could not differentiate glaucoma from increased physiological cupping when using color retinography assessment alone. Diagnostic accuracy and inter-rater agreement improved significantly with the addition of visual field or optical coherence tomography. However, the use of both modalities did not improve sensitivity/specificity.",2021,"Accuracy was highest in GII (81.3% [95%CI, 77.1-84.8]), followed by GIII (79% [95%CI, 74.7-82.7]), GIV (70,5% [95%CI, 65.9-74.8]), and GI (64.8% [95%CI, 60.0-69.3]). ","['Twenty non-specialist ophthalmologists diagnosed glaucoma from PowerPoint slide images, without direct patient examination', 'Eighty patients with glaucoma or physiological cupping (40 of each']","['computerized campimetry and/or optical coherence tomography', 'examination used (GI: color retinography, GII: color retinography + visual field, GIII: color retinography + optical coherence tomography, GIV: color retinography + visual field + optical coherence tomography', 'visual field and/or optical coherence tomography (OCT) combined with color retinography']","['Sensitivity and specificity', 'sensitivity/specificity', 'Diagnostic accuracy', 'Diagnostic accuracy and inter-rater agreement', 'Accuracy']","[{'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C1704292', 'cui_str': 'Ophthalmologist'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0332246', 'cui_str': 'Sliding'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}]","[{'cui': 'C0006810', 'cui_str': 'Campimetry'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0522507', 'cui_str': 'With color'}]","[{'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}]",80.0,0.213809,"Accuracy was highest in GII (81.3% [95%CI, 77.1-84.8]), followed by GIII (79% [95%CI, 74.7-82.7]), GIV (70,5% [95%CI, 65.9-74.8]), and GI (64.8% [95%CI, 60.0-69.3]). ","[{'ForeName': 'Cláudia Gomide Vilela de Sousa', 'Initials': 'CGVS', 'LastName': 'Franco', 'Affiliation': 'Ophthalmology Department, Universidade Federal de Goiás, Goiânia, GO, Brazil.'}, {'ForeName': 'Marcos Pereira de', 'Initials': 'MP', 'LastName': 'Ávila', 'Affiliation': 'Ophthalmology Department, Universidade Federal de Goiás, Goiânia, GO, Brazil.'}, {'ForeName': 'Leopoldo', 'Initials': 'L', 'LastName': 'Magacho', 'Affiliation': 'Ophthalmology Department, Universidade Federal de Goiás, Goiânia, GO, Brazil.'}]",Arquivos brasileiros de oftalmologia,['10.5935/0004-2749.20210016'] 2186,33570548,Validation of a 22-Gene Genomic Classifier in Patients With Recurrent Prostate Cancer: An Ancillary Study of the NRG/RTOG 9601 Randomized Clinical Trial.,"Importance Decipher (Decipher Biosciences Inc) is a genomic classifier (GC) developed to estimate the risk of distant metastasis (DM) after radical prostatectomy (RP) in patients with prostate cancer. Objective To validate the GC in the context of a randomized phase 3 trial. Design, Setting, and Participants This ancillary study used RP specimens from the phase 3 placebo-controlled NRG/RTOG 9601 randomized clinical trial conducted from March 1998 to March 2003. The specimens were centrally reviewed, and RNA was extracted from the highest-grade tumor available in 2019 with a median follow-up of 13 years. Clinical-grade whole transcriptomes from samples passing quality control were assigned GC scores (scale, 0-1). A National Clinical Trials Network-approved prespecified statistical plan included the primary objective of validating the independent prognostic ability of GC for DM, with secondary end points of prostate cancer-specific mortality (PCSM) and overall survival (OS). Data were analyzed from September 2019 to December 2019. Intervention Salvage radiotherapy (sRT) with or without 2 years of bicalutamide. Main Outcomes and Measures The preplanned primary end point of this study was the independent association of the GC with the development of DM. Results In this ancillary study of specimens from a phase 3 randomized clinical trial, GC scores were generated from 486 of 760 randomized patients with a median follow-up of 13 years; samples from a total of 352 men (median [interquartile range] age, 64.5 (60-70) years; 314 White [89.2%] participants) passed microarray quality control and comprised the final cohort for analysis. On multivariable analysis, the GC (continuous variable, per 0.1 unit) was independently associated with DM (hazard ratio [HR], 1.17; 95% CI, 1.05-1.32; P = .006), PCSM (HR, 1.39; 95% CI, 1.20-1.63; P < .001), and OS (HR, 1.17; 95% CI, 1.06-1.29; P = .002) after adjusting for age, race/ethnicity, Gleason score, T stage, margin status, entry prostate-specific antigen, and treatment arm. Although the original planned analysis was not powered to detect a treatment effect interaction by GC score, the estimated absolute effect of bicalutamide on 12-year OS was less when comparing patients with lower vs higher GC scores (2.4% vs 8.9%), which was further demonstrated in men receiving early sRT at a prostate-specific antigen level lower than 0.7 ng/mL (-7.8% vs 4.6%). Conclusions and Relevance This ancillary validation study of the Decipher GC in a randomized trial cohort demonstrated association of the GC with DM, PCSM, and OS independent of standard clinicopathologic variables. These results suggest that not all men with biochemically recurrent prostate cancer after surgery benefit equally from the addition of hormone therapy to sRT. Trial Registration ClinicalTrials.gov identifier: NCT00002874.",2021,"On multivariable analysis, the GC (continuous variable, per 0.1 unit) was independently associated with DM (hazard ratio [HR], 1.17; 95% CI, 1.05-1.32; P = .006), PCSM (HR, 1.39; 95% CI, 1.20-1.63; P < .001), and OS (HR, 1.17; 95% CI, 1.06-1.29; P = .002) after adjusting for age, race/ethnicity, Gleason score, T stage, margin status, entry prostate-specific antigen, and treatment arm.","['With Recurrent Prostate Cancer', '486 of 760 randomized patients with a median follow-up of 13 years; samples from a total of 352 men (median [interquartile range] age, 64.5 (60-70) years; 314 White [89.2%] participants) passed microarray quality control and comprised the final cohort for analysis', 'Patients', 'patients with prostate cancer']","['radical prostatectomy (RP', 'Intervention\n\n\nSalvage radiotherapy (sRT) with or without 2 years of bicalutamide', 'bicalutamide']",['prostate cancer-specific mortality (PCSM) and overall survival (OS'],"[{'cui': 'C0278838', 'cui_str': 'Prostate cancer recurrent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0285590', 'cui_str': 'bicalutamide'}]","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",760.0,0.230703,"On multivariable analysis, the GC (continuous variable, per 0.1 unit) was independently associated with DM (hazard ratio [HR], 1.17; 95% CI, 1.05-1.32; P = .006), PCSM (HR, 1.39; 95% CI, 1.20-1.63; P < .001), and OS (HR, 1.17; 95% CI, 1.06-1.29; P = .002) after adjusting for age, race/ethnicity, Gleason score, T stage, margin status, entry prostate-specific antigen, and treatment arm.","[{'ForeName': 'Felix Y', 'Initials': 'FY', 'LastName': 'Feng', 'Affiliation': 'Department of Radiation Oncology, UCSF Medical Center, San Francisco, California.'}, {'ForeName': 'Huei-Chung', 'Initials': 'HC', 'LastName': 'Huang', 'Affiliation': 'Decipher Biosciences, San Diego, California.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Spratt', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Shuang George', 'Initials': 'SG', 'LastName': 'Zhao', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Sandler', 'Affiliation': 'Department of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Jeffry P', 'Initials': 'JP', 'LastName': 'Simko', 'Affiliation': 'NRG Biorepository, Department of Pathology, UCSF Medical Center, San Francisco, California.'}, {'ForeName': 'Elai', 'Initials': 'E', 'LastName': 'Davicioni', 'Affiliation': 'Decipher Biosciences, San Diego, California.'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Nguyen', 'Affiliation': ""Department of Radiation Oncology, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Pollack', 'Affiliation': 'Department of Radiation Oncology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Efstathiou', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Dicker', 'Affiliation': 'Department of Radiation Oncology, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Todorovic', 'Affiliation': 'Decipher Biosciences, San Diego, California.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Margrave', 'Affiliation': 'Decipher Biosciences, San Diego, California.'}, {'ForeName': 'Yang Seagle', 'Initials': 'YS', 'LastName': 'Liu', 'Affiliation': 'Decipher Biosciences, San Diego, California.'}, {'ForeName': 'Bashar', 'Initials': 'B', 'LastName': 'Dabbas', 'Affiliation': 'Decipher Biosciences, San Diego, California.'}, {'ForeName': 'Darby J S', 'Initials': 'DJS', 'LastName': 'Thompson', 'Affiliation': 'Emmes Canada, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Rajdeep', 'Initials': 'R', 'LastName': 'Das', 'Affiliation': 'Department of Radiation Oncology, UCSF Medical Center, San Francisco, California.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Dignam', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Sweeney', 'Affiliation': 'Department of Medicine, Dana-Farber/Harvard Cancer Center, Boston, Massachusetts.'}, {'ForeName': 'Gerhardt', 'Initials': 'G', 'LastName': 'Attard', 'Affiliation': 'Department of Oncology, University College London, London, United Kingdom.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Bahary', 'Affiliation': ""Department of Radiation Oncology, Centre Hospitalier de l'Université de Montréal-Notre Dame, Montreal, Quebec, Canada.""}, {'ForeName': 'Himanshu R', 'Initials': 'HR', 'LastName': 'Lukka', 'Affiliation': 'Department of Radiation Oncology, Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Hall', 'Affiliation': 'Department of Radiation Oncology, Froedtert and the Medical College of Wisconsin, Madison, Wisconsin.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Pisansky', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Amit B', 'Initials': 'AB', 'LastName': 'Shah', 'Affiliation': 'Department of Radiation Oncology, WellSpan Health-York Cancer Center accruals under Thomas Jefferson University Hospital, Philadelphia, Pennsylvania.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Pugh', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'William U', 'Initials': 'WU', 'LastName': 'Shipley', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Phuoc T', 'Initials': 'PT', 'LastName': 'Tran', 'Affiliation': 'Department of Radiation Oncology, Johns Hopkins University, Baltimore, Maryland.'}]",JAMA oncology,['10.1001/jamaoncol.2020.7671'] 2187,33820931,Baseline low-density lipoprotein cholesterol predicts the benefit of adding ezetimibe on statin in statin-naïve acute coronary syndrome.,"We aimed to evaluate the effect of baseline low-density lipoprotein cholesterol (LDL-C) on the outcomes of patients with the acute coronary syndrome (ACS) receiving pitavastatin monotherapy or the combination of pitavastatin + ezetimibe. In the HIJ-PROPER study, 1734 ACS patients with dyslipidemia were randomly assigned to receive pitavastatin or pitavastatin + ezetimibe therapy. Statin-naïve participants (n = 1429) were divided into two groups based on the median LDL-C level (131 mg/dL) at enrollment. The primary endpoint was a composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, unstable angina, and ischemia-driven coronary revascularization. The median follow-up was 3.2 years. In the < 131 mg/dL group (n = 686), LDL-C changes were - 34.0% and - 49.8% in the pitavastatin monotherapy and pitavastatin + ezetimibe-treated groups (P < 0.0001), respectively; in the ≥ 131 mg/dL group (n = 743), LDL-C changes were - 42.9% and - 56.4% (P < 0.0001, respectively. Kaplan-Meier analyses revealed that the primary endpoint was not significantly different between the treatment groups for the < 131 mg/dL group, however, it was significantly lower in patients treated with pitavastatin + ezetimibe in the ≥ 131 mg/dL group (Hazard ratio = 0.72, 95% confidence interval = 0.56-0.91, P = 0.007, P value for interaction = 0.012). Statin-naïve ACS patients with baseline LDL-C < 131 mg/dL did not clinically benefit from pitavastatin + ezetimibe, while patients with baseline LDL-C ≥ 131 mg/dL treated with pitavastatin + ezetimibe showed better clinical results than those treated with pitavastatin monotherapy.Clinical Trial Registration: Original HIJ PROPER study; URL: http://www.umin.ac.jp/ctr . Unique Identifier; UMIN000002742, registered as an International Standard Randomized Controlled Trial.",2021,"Kaplan-Meier analyses revealed that the primary endpoint was not significantly different between the treatment groups for the < 131 mg/dL group, however, it was significantly lower in patients treated with pitavastatin + ezetimibe in the ≥ ","['Statin-naïve participants (n\u2009=\u20091429', 'naïve ACS patients with baseline LDL-C', '1734 ACS patients with dyslipidemia', 'patients with the acute coronary syndrome (ACS) receiving pitavastatin monotherapy or the combination of', 'statin-naïve acute coronary syndrome']","['Statin', 'pitavastatin monotherapy', 'pitavastatin\u2009+\u2009ezetimibe', 'pitavastatin or pitavastatin\u2009+\u2009ezetimibe therapy', 'ezetimibe', 'baseline low-density lipoprotein cholesterol (LDL-C']","['composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, unstable angina, and ischemia-driven coronary revascularization', 'LDL-C changes']","[{'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0002455', 'cui_str': 'American Cancer Society'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C1101838', 'cui_str': 'pitavastatin'}]","[{'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C1101838', 'cui_str': 'pitavastatin'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",1734.0,0.138929,"Kaplan-Meier analyses revealed that the primary endpoint was not significantly different between the treatment groups for the < 131 mg/dL group, however, it was significantly lower in patients treated with pitavastatin + ezetimibe in the ≥ ","[{'ForeName': 'Jihaeng', 'Initials': 'J', 'LastName': 'Im', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, 8-1, Kawada-cho, Shinjuku, Tokyo, 162-8666, Japan.""}, {'ForeName': 'Erisa', 'Initials': 'E', 'LastName': 'Kawada-Watanabe', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, 8-1, Kawada-cho, Shinjuku, Tokyo, 162-8666, Japan.""}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Yamaguchi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, 8-1, Kawada-cho, Shinjuku, Tokyo, 162-8666, Japan. j.yamaguchi0110@gmail.com.""}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Arashi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, 8-1, Kawada-cho, Shinjuku, Tokyo, 162-8666, Japan.""}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Otsuki', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, 8-1, Kawada-cho, Shinjuku, Tokyo, 162-8666, Japan.""}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Matsui', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, 8-1, Kawada-cho, Shinjuku, Tokyo, 162-8666, Japan.""}, {'ForeName': 'Haruki', 'Initials': 'H', 'LastName': 'Sekiguchi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, 8-1, Kawada-cho, Shinjuku, Tokyo, 162-8666, Japan.""}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Fujii', 'Affiliation': 'Department of Cardiology, Cardiovascular Center of Sendai, Miyagi, Japan.'}, {'ForeName': 'Fumiaki', 'Initials': 'F', 'LastName': 'Mori', 'Affiliation': 'Department of Cardiology, Yokohama Medical Center, Kanagawa, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ogawa', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, 8-1, Kawada-cho, Shinjuku, Tokyo, 162-8666, Japan.""}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Hagiwara', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, 8-1, Kawada-cho, Shinjuku, Tokyo, 162-8666, Japan.""}]",Scientific reports,['10.1038/s41598-021-87098-x'] 2188,33571868,"Body composition and weight changes after ivacaftor treatment in adults with cystic fibrosis carrying the G551 D cystic fibrosis transmembrane conductance regulator mutation: A double-blind, placebo-controlled, randomized, crossover study with open-label extension.","OBJECTIVES In patients with cystic fibrosis (CF) who carry the G551D mutation, treatment with ivacaftor improves lung function and weight; however, short- and long-term impacts on body composition have not been well studied. METHODS Twenty adults with CF carrying the G551D mutation (mean ± standard deviation body mass index [BMI] 23.3 ± 4.3 kg/m 2 ) were recruited for a single-center, double-blind, placebo-controlled, 28-d, crossover study of ivacaftor, followed by an open-label extension (OLE) for 5 mo. Eleven patients underwent measurements 2 y later. The study variables included weight, BMI, and body composition (including fat-free mass [FFM] and fat mass). RESULTS After 28 d of treatment with ivacaftor, weight increased by 1.1 ± 1.3 kg, BMI by 0.4 ± 0.5 kg/m 2 , and FFM by 1.1 ± 1.2 kg (all P < .005) with no change in fat mass. Differences between 28-d changes on ivacaftor and placebo were not statistically significant. In the following 5 mo of the OLE, there were significant increases in weight (1.2 ± 1.9 kg; P < .05) and fat mass (1.5 ± 1.9 kg; P < .01), but not in FFM. Between baseline and the end of the OLE, the total weight gain was 2.5 ± 2.4 kg (P < .005), comprised of 0.9 ± 1.5 kg FFM (P < .05) and 1.6 ± 1.8 kg fat mass (P < .005). For the 11 participants who were followed for a further 2 y, no further changes in mean weight, BMI, or body composition parameters between 6 mo and 2 y later were observed. CONCLUSIONS Small gains were seen in FFM in the first month of ivacaftor treatment. Weight, BMI, and fat-mass gains in the first 6 mo on ivacaftor plateaued by 2.5 y. The metabolic and clinical consequences of weight and fat-mass gains remain to be determined.",2021,Differences between 28-d changes on ivacaftor and placebo were not statistically significant.,"['Twenty adults with CF carrying the G551D mutation (mean ± standard deviation body mass index', 'adults with cystic fibrosis carrying the G551 D cystic fibrosis transmembrane conductance regulator mutation', 'patients with cystic fibrosis (CF) who carry the G551D mutation, treatment with', 'Eleven patients underwent measurements 2']","['ivacaftor treatment', 'ivacaftor', 'placebo']","['weight', 'lung function and weight', 'fat mass', 'mean weight, BMI, or body composition parameters', 'weight, BMI, and body composition (including fat-free mass [FFM] and fat mass', 'Weight, BMI, and fat-mass gains', 'Body composition and weight changes', 'FFM', 'total weight gain']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0056889', 'cui_str': 'CFTR Protein'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]","[{'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0271093', 'cui_str': ""Stargardt's disease""}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",20.0,0.0404613,Differences between 28-d changes on ivacaftor and placebo were not statistically significant.,"[{'ForeName': 'Susannah J', 'Initials': 'SJ', 'LastName': 'King', 'Affiliation': 'Nutrition Department, Alfred Hospital, Melbourne, Victoria, Australia; Cystic Fibrosis Service, Department of Respiratory Medicine, Alfred Hospital, Melbourne, Victoria, Australia; Department of Dietetics, Nutrition and Sport, LaTrobe University, Victoria, Australia. Electronic address: s.king@alfred.org.au.'}, {'ForeName': 'Audrey C', 'Initials': 'AC', 'LastName': 'Tierney', 'Affiliation': 'Nutrition Department, Alfred Hospital, Melbourne, Victoria, Australia; Cystic Fibrosis Service, Department of Respiratory Medicine, Alfred Hospital, Melbourne, Victoria, Australia; Department of Dietetics, Nutrition and Sport, LaTrobe University, Victoria, Australia; School of Allied Health, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'Deirdre', 'Initials': 'D', 'LastName': 'Edgeworth', 'Affiliation': ""Cystic Fibrosis Service, Department of Respiratory Medicine, Alfred Hospital, Melbourne, Victoria, Australia; Department of Anesthesia and Intensive Care Medicine, St James' Hospital, Dublin, Ireland.""}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Keating', 'Affiliation': 'Cystic Fibrosis Service, Department of Respiratory Medicine, Alfred Hospital, Melbourne, Victoria, Australia; Department of Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Elyssa', 'Initials': 'E', 'LastName': 'Williams', 'Affiliation': 'Cystic Fibrosis Service, Department of Respiratory Medicine, Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Kotsimbos', 'Affiliation': 'Cystic Fibrosis Service, Department of Respiratory Medicine, Alfred Hospital, Melbourne, Victoria, Australia; Department of Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Brenda M', 'Initials': 'BM', 'LastName': 'Button', 'Affiliation': 'Cystic Fibrosis Service, Department of Respiratory Medicine, Alfred Hospital, Melbourne, Victoria, Australia; Department of Medicine, Monash University, Melbourne, Victoria, Australia; Physiotherapy Department, Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Wilson', 'Affiliation': 'Cystic Fibrosis Service, Department of Respiratory Medicine, Alfred Hospital, Melbourne, Victoria, Australia; Department of Medicine, Monash University, Melbourne, Victoria, Australia.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.111124'] 2189,33571034,Low-dose CT urography using deep learning image reconstruction: a prospective study for comparison with conventional CT urography.,"OBJECTIVES To compare the image quality of low-dose CT urography (LD-CTU) using deep learning image reconstruction (DLIR) with conventional CTU (C-CTU) using adaptive statistical iterative reconstruction (ASIR-V). METHODS This was a prospective, single-institutional study using the excretory phase CTU images for analysis. Patients were assigned to the LD-DLIR group (100kV and automatic mA modulation for noise index (NI) of 23) and C-ASIR-V group (100kV and NI of 10) according to the scan protocols in the excretory phase. Two radiologists independently assessed the overall image quality, artifacts, noise and sharpness of urinary tracts. Additionally, the mean CT attenuation, signal-to-noise ratio (SNR) and contrast-to-noise (CNR) in the urinary tracts were evaluated. RESULTS 26 patients each were included in the LD-DLIR group (10 males and 16 females; mean age: 57.23 years, range: 33-76 years) and C-ASIR-V group (14 males and 12 females; mean age: 60 years, range: 33-77 years). LD-DLIR group used a significantly lower effective radiation dose compared with the C-ASIR-V group (2.01 ± 0.44 mSv vs 6.9 ± 1.46 mSv, p < 0.001). LD-DLIR group showed good overall image quality with average score >4 and was similar to that of the C-ASIR-V group. Both groups had adequate and similar attenuation value, SNR and CNR in most segments of urinary tracts. CONCLUSION It is feasibility to provide comparable image quality while reducing 71% radiation dose in low-dose CTU with a deep learning image reconstruction algorithm compared to the conventional CTU with ASIR-V. ADVANCES IN KNOWLEDGE (1) CT urography with deep learning reconstruction algorithm can reduce the radiation dose by 71% while still maintaining image quality.",2021,LD-DLIR group showed good overall image quality with average score >4 and was similar to that of the C-ASIR-V group.,"['26 patients each were included in the LD-DLIR group (10 males and 16 females; mean age: 57.23 years, range: 33-76 years) and C-ASIR-V group (14 males and 12 females; mean age: 60 years, range: 33-77 years']","['deep learning image reconstruction (DLIR) with conventional CTU (C-CTU', 'Low-dose CT urography', 'conventional CT urography', 'low-dose CT urography (LD-CTU', 'LD-DLIR group (100kV and automatic mA modulation for noise index (NI) of 23) and C-ASIR-V group (100kV and NI of 10) according to the scan protocols', 'CT urography with deep learning reconstruction algorithm']","['overall image quality, artefact, noise and sharpness of urinary tracts', 'overall image quality', 'mean attenuation, signal-to-noise ratio (SNR) and contrast-to-noise (CNR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1504583', 'cui_str': 'CT urography'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0085089', 'cui_str': 'Artifact'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C1508753', 'cui_str': 'Urinary system structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}]",,0.0162464,LD-DLIR group showed good overall image quality with average score >4 and was similar to that of the C-ASIR-V group.,"[{'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': ""Department of Radiology, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710061, Shaanxi province, PR China.""}, {'ForeName': 'Yangyang', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': ""Department of Radiology, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710061, Shaanxi province, PR China.""}, {'ForeName': 'Jianying', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'GE Healthcare, Computed Tomography Research Center, Beijing, 100176, PR China.'}, {'ForeName': 'Ganglian', 'Initials': 'G', 'LastName': 'Fan', 'Affiliation': ""Department of Radiology, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710061, Shaanxi province, PR China.""}, {'ForeName': 'Le', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': ""Department of Radiology, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710061, Shaanxi province, PR China.""}, {'ForeName': 'Junjun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Radiology, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710061, Shaanxi province, PR China.""}, {'ForeName': 'Xiaoqian', 'Initials': 'X', 'LastName': 'Jia', 'Affiliation': ""Department of Radiology, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710061, Shaanxi province, PR China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Radiology, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710061, Shaanxi province, PR China.""}, {'ForeName': 'Jianxin', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': ""Department of Radiology, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710061, Shaanxi province, PR China.""}]",The British journal of radiology,['10.1259/bjr.20201291'] 2190,33580606,Effect of laughter yoga on mental symptoms and salivary cortisol levels in first-year nursing students: A randomized controlled trial.,"BACKGROUND University students are faced with several stress factors affecting their mental health. Therefore, the first year at university is a period that calls for careful attention and research. AIM The aim of this study is to evaluate the effect of laughter yoga on mental symptoms and cortisol levels in nursing students. METHODS This study is a randomized controlled study employing a pre-/post-test design with a control group. A total of 75 healthy university students were assigned to the intervention group and control group. The Brief Symptom Inventory was applied to both groups before Session 1 and after Session 8. Saliva samples were taken from the students to measure their cortisol levels before and after each session. RESULTS Evaluation of the mean scores obtained from the Brief Symptom Inventory before and after the intervention showed a significant decrease in the scores between groups (P < 0.05). In three out of the eight sessions, there was a significant decrease in the intervention group compared with the control group regarding the mean values of pre-test and post-test salivary cortisol levels (P < 0.05). CONCLUSION Laughter yoga can provide an effective means to help first-year nursing students cope with stress and reduce mental symptoms.",2021,"In three out of the eight sessions, there was a significant decrease in the intervention group compared with the control group regarding the mean values of pre-test and post-test salivary cortisol levels (P < 0.05). ","['nursing students', '75 healthy university students', 'first-year nursing students', 'University students']","['Laughter yoga', 'laughter yoga']","['mean values of pre-test and post-test salivary cortisol levels', 'mental symptoms and salivary cortisol levels', 'mental symptoms and cortisol levels']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4045984', 'cui_str': 'Laughter Yoga'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}]",75.0,0.0455894,"In three out of the eight sessions, there was a significant decrease in the intervention group compared with the control group regarding the mean values of pre-test and post-test salivary cortisol levels (P < 0.05). ","[{'ForeName': 'Fatma Ozlem', 'Initials': 'FO', 'LastName': 'Ozturk', 'Affiliation': 'Department of Nursing, Faculty of Nursing, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Ayfer', 'Initials': 'A', 'LastName': 'Tezel', 'Affiliation': 'Department of Nursing, Faculty of Nursing, Ankara University, Ankara, Turkey.'}]",International journal of nursing practice,['10.1111/ijn.12924'] 2191,33582490,Effects of acute distress and tobacco cues on tobacco demand.,"INTRODUCTION Cigarette demand, or relative value, can be assessed via analysis of performance on a hypothetical behavioral economic cigarette purchase task (CPT). Substance purchase tasks are highly amenable to manipulation, namely, external stimuli, instructional changes, or acute stressors. In this regard, the current secondary analysis evaluates the role a novel, computerized stress induction paradigm, the Contextual-Frustration Intolerance Typing Task (C-FiTT), plays in eliciting varying levels of stress and resulting demand. METHOD Daily smokers (n = 484) completed the C-FiTT wherein they were randomly assigned to one of five distress conditions: combination of task difficulty (low or high difficulty) with neutral or withdrawal cues, and a neutral control group. Tobacco demand was assessed immediately following the distress task using the hypothetical CPT. RESULTS The C-FiTT distress-induction task significantly increased key cigarette demand indices, including price at maximum expenditure (P max ) and first price where consumption was suppressed to zero (breakpoint). Moreover, demand increased with severity of C-FiTT condition, with the high-difficulty condition resulting in significantly higher breakpoint and P max , compared to other conditions. C-FiTT condition was not related to a significant increase in O max , intensity, or elasticity. DISCUSSION The novel C-FiTT paradigm produced comparable effects on tobacco demand relative to in vivo withdrawal induction, indicating that the C-FiTT is a viable procedure by which to influence demand. Reduction of internal and external stressors may be effective in lowering motivation for tobacco. These results highlight the importance of state distress in tobacco demand, and offer a potential avenue for intervention.",2021,"The C-FiTT distress-induction task significantly increased key cigarette demand indices, including price at maximum expenditure (P max ) and first price where consumption was suppressed to zero (breakpoint).",['Daily smokers (n = 484) completed the C-FiTT wherein they were randomly assigned to one of five distress conditions'],"['combination of task difficulty (low or high difficulty) with neutral or withdrawal cues, and a neutral control group']","['price at maximum expenditure (P max ) and first price where consumption', 'O max , intensity, or elasticity']","[{'cui': 'C3266136', 'cui_str': 'Smokes tobacco daily'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0016770', 'cui_str': 'Feeling frustrated'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0441704', 'cui_str': 'Typings'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0080045', 'cui_str': 'Prices'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",484.0,0.0173953,"The C-FiTT distress-induction task significantly increased key cigarette demand indices, including price at maximum expenditure (P max ) and first price where consumption was suppressed to zero (breakpoint).","[{'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Aston', 'Affiliation': 'Brown University School of Public Health, Center for Alcohol and Addiction Studies, Providence, RI USA. Electronic address: Elizabeth_Aston@Brown.edu.'}, {'ForeName': 'Jacqueline E', 'Initials': 'JE', 'LastName': 'Smith', 'Affiliation': 'Brown University School of Public Health, Center for Alcohol and Addiction Studies, Providence, RI USA.'}, {'ForeName': 'Angelo M', 'Initials': 'AM', 'LastName': 'DiBello', 'Affiliation': 'Brown University School of Public Health, Center for Alcohol and Addiction Studies, Providence, RI USA; City University of New York (CUNY), Brooklyn College, Brooklyn, NY USA.'}, {'ForeName': 'Samantha G', 'Initials': 'SG', 'LastName': 'Farris', 'Affiliation': 'Rutgers, the State University of New Jersey, Piscataway, NJ, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.108522'] 2192,33587135,Effects of Tai Chi or Exercise on Sleep in Older Adults With Insomnia: A Randomized Clinical Trial.,"Importance Previous studies that have shown tai chi to improve sleep were mainly based on subjective assessments, which might have produced results confounded by self-reporting bias. Objective To compare the effectiveness of tai chi for improving sleep in older adults with insomnia with conventional exercise and a passive control group using actigraphy-based objective measurements. Design, Setting, and Participants This randomized, 3-arm, parallel group, assessor-masked clinical trial was conducted at a single research unit in Hong Kong between August 2014 and August 2018. Eligible participants, aged 60 years or older and with chronic insomnia, were randomly allocated into tai chi training, exercise, and control groups. Interventions 12-week tai chi training, 12-week conventional exercise, and no intervention control. Main Outcomes and Measures Primary outcomes were measures taken from actigraphy sleep assessment. Secondary outcomes included remission of insomnia, insomnia treatment response, Pittsburgh Sleep Quality Index score, Insomnia Severity Index score, and self-reported sleep using a 7-day sleep diary. Assessments were performed at baseline, end of the intervention (postintervention), and 24 months after the intervention (follow-up). Data analysis was performed from September 2018 to August 2020. Results A total of 320 participants (mean [SD] age, 67.3 [6.8] years; mean [SD] insomnia duration, 124.4 [134.5] months; 256 [80.0%] women) were randomly allocated into control (110 participants), exercise (105 participants), and tai chi (105 participants) groups and included in the data analysis. Compared with the control group, the exercise and tai chi groups showed improved sleep efficiency (exercise vs control: adjusted mean difference, +3.5%; 95% CI, 1.8-5.2; P < .001; tai chi vs control: adjusted mean difference, +3.4%; 95% CI, 1.6-5.1; P < .001) and reductions of wake time after sleep onset (exercise vs control: -17.0 minutes; 95% CI, -24.9 to -9.0; P < .001; tai chi vs control: -13.3 minutes; 95% CI, -21.3 to -5.2; P = .001) and number of awakenings (exercise vs control: -2.8 times; 95% CI, -4.0 to -1.6; P < .001; tai chi vs control: -2.2 times; 95% CI, -3.5 to -1.0; P < .001) as assessed by actigraphy at postintervention; although there were no significant differences between the exercise and tai chi groups. The actigraphy-assessed beneficial effects were maintained in both intervention groups at follow-up. Conclusions and Relevance Conventional exercise and tai chi improved sleep and the beneficial effects sustained for 24 months, although the absolute improvements in sleep parameters were modest. Improvements in objective sleep parameters were not different between the tai chi and exercise groups, suggesting that tai chi can be an alternative approach for managing insomnia. Trial Registration ClinicalTrials.gov Identifier: NCT02260843.",2021,"Compared with the control group, the exercise and tai chi groups showed improved sleep efficiency (exercise vs control: adjusted mean difference, +3.5%; 95% CI, 1.8-5.2; P < .001; tai chi vs control: adjusted mean difference, +3.4%; 95% CI, 1.6-5.1; P < .001) and reductions of wake time after sleep onset (exercise vs control: -17.0 minutes; 95% CI, -24.9 to -9.0; P < .001; tai chi vs control: -13.3 minutes; 95% CI, -21.3 to -5.2; P = .001) and number of awakenings (exercise vs control: -2.8 times; 95% CI, -4.0 to -1.6; P < .001; tai chi vs control: -2.2 times; 95% CI, -3.5 to -1.0; P < .001) as assessed by actigraphy at postintervention; although there were no significant differences between the exercise and tai chi groups.","['single research unit in Hong Kong between August 2014 and August 2018', 'Eligible participants, aged 60 years or older and with chronic insomnia', 'older adults with insomnia with conventional exercise and a passive control group using actigraphy-based objective measurements', '320 participants (mean [SD] age, 67.3 [6.8] years; mean [SD] insomnia duration, 124.4 [134.5] months; 256 [80.0%] women', 'Older Adults With Insomnia']","['tai chi training, 12-week conventional exercise, and no intervention control', 'tai chi training, exercise, and control groups', 'Tai Chi or Exercise', 'tai chi']","['remission of insomnia, insomnia treatment response, Pittsburgh Sleep Quality Index score, Insomnia Severity Index score, and self-reported sleep using a 7-day sleep diary', 'objective sleep parameters', 'sleep efficiency', 'reductions of wake time after sleep onset', 'measures taken from actigraphy sleep assessment', 'number of awakenings', 'actigraphy-assessed beneficial effects']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C4706228', 'cui_str': 'ISI (Insomnia Severity Index) score'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",320.0,0.106652,"Compared with the control group, the exercise and tai chi groups showed improved sleep efficiency (exercise vs control: adjusted mean difference, +3.5%; 95% CI, 1.8-5.2; P < .001; tai chi vs control: adjusted mean difference, +3.4%; 95% CI, 1.6-5.1; P < .001) and reductions of wake time after sleep onset (exercise vs control: -17.0 minutes; 95% CI, -24.9 to -9.0; P < .001; tai chi vs control: -13.3 minutes; 95% CI, -21.3 to -5.2; P = .001) and number of awakenings (exercise vs control: -2.8 times; 95% CI, -4.0 to -1.6; P < .001; tai chi vs control: -2.2 times; 95% CI, -3.5 to -1.0; P < .001) as assessed by actigraphy at postintervention; although there were no significant differences between the exercise and tai chi groups.","[{'ForeName': 'Parco M', 'Initials': 'PM', 'LastName': 'Siu', 'Affiliation': 'Division of Kinesiology, School of Public Health, Li Ka Shing Faculty of Medicine, the University of Hong Kong, Pokfulam, Hong Kong, China.'}, {'ForeName': 'Angus P', 'Initials': 'AP', 'LastName': 'Yu', 'Affiliation': 'Division of Kinesiology, School of Public Health, Li Ka Shing Faculty of Medicine, the University of Hong Kong, Pokfulam, Hong Kong, China.'}, {'ForeName': 'Bjorn T', 'Initials': 'BT', 'LastName': 'Tam', 'Affiliation': 'Department of Health, Kinesiology and Applied Physiology, Concordia University, Montreal, Canada.'}, {'ForeName': 'Edwin C', 'Initials': 'EC', 'LastName': 'Chin', 'Affiliation': 'Division of Kinesiology, School of Public Health, Li Ka Shing Faculty of Medicine, the University of Hong Kong, Pokfulam, Hong Kong, China.'}, {'ForeName': 'Doris S', 'Initials': 'DS', 'LastName': 'Yu', 'Affiliation': 'School of Nursing, Li Ka Shing Faculty of Medicine, the University of Hong Kong, Pokfulam, Hong Kong, China.'}, {'ForeName': 'Ka-Fai', 'Initials': 'KF', 'LastName': 'Chung', 'Affiliation': 'Department of Psychiatry, Li Ka Shing Faculty of Medicine, the University of Hong Kong, Pokfulam, Hong Kong, China.'}, {'ForeName': 'Stanley S', 'Initials': 'SS', 'LastName': 'Hui', 'Affiliation': 'Department of Sports Science and Physical Education, Faculty of Education, the Chinese University of Hong Kong, Shatin, Hong Kong, China.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Woo', 'Affiliation': 'Department of Medicine and Therapeutics, Faculty of Medicine, the Chinese University of Hong Kong, Shatin, Hong Kong, China.'}, {'ForeName': 'Daniel Y', 'Initials': 'DY', 'LastName': 'Fong', 'Affiliation': 'School of Nursing, Li Ka Shing Faculty of Medicine, the University of Hong Kong, Pokfulam, Hong Kong, China.'}, {'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, Faculty of Health and Social Sciences, the Hong Kong Polytechnic University, Hung Hom, Hong Kong, China.'}, {'ForeName': 'Gao X', 'Initials': 'GX', 'LastName': 'Wei', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Irwin', 'Affiliation': 'Cousins Center for Psychoneuroimmunology and Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.37199'] 2193,33587132,Effect of a Coordinated Community and Chronic Care Model Team Intervention vs Usual Care on Systolic Blood Pressure in Patients With Stroke or Transient Ischemic Attack: The SUCCEED Randomized Clinical Trial.,"Importance Few stroke survivors meet recommended cardiovascular goals, particularly among racial/ethnic minority populations, such as Black or Hispanic individuals, or socioeconomically disadvantaged populations. Objective To determine if a chronic care model-based, community health worker (CHW), advanced practice clinician (APC; including nurse practitioners or physician assistants), and physician team intervention improves risk factor control after stroke in a safety-net setting (ie, health care setting where all individuals receive care, regardless of health insurance status or ability to pay). Design, Setting, and Participants This randomized clinical trial included participants recruited from 5 hospitals serving low-income populations in Los Angeles County, California, as part of the Secondary Stroke Prevention by Uniting Community and Chronic Care Model Teams Early to End Disparities (SUCCEED) clinical trial. Inclusion criteria were age 40 years or older; experience of ischemic or hemorrhagic stroke or transient ischemic attack (TIA) no more than 90 days prior; systolic blood pressure (BP) of 130 mm Hg or greater or 120 to 130 mm Hg with history of hypertension or using hypertensive medications; and English or Spanish language proficiency. The exclusion criterion was inability to consent. Among 887 individuals screened for eligibility, 542 individuals were eligible, and 487 individuals were enrolled and randomized, stratified by stroke type (ischemic or TIA vs hemorrhagic), language (English vs Spanish), and site to usual care vs intervention in a 1:1 fashion. The study was conducted from February 2014 to September 2018, and data were analyzed from October 2018 to November 2020. Interventions Participants randomized to intervention were offered a multimodal coordinated care intervention, including hypothesized core components (ie, ≥3 APC clinic visits, ≥3 CHW home visits, and Chronic Disease Self-Management Program workshops), and additional telephone visits, protocol-driven risk factor management, culturally and linguistically tailored education materials, and self-management tools. Participants randomized to the control group received usual care, which varied by site but frequently included a free BP monitor, self-management tools, and linguistically tailored information materials. Main Outcomes and Measures The primary outcome was change in systolic BP at 12 months. Secondary outcomes were non-high density lipoprotein cholesterol, hemoglobin A1c, and C-reactive protein (CRP) levels, body mass index, antithrombotic adherence, physical activity level, diet, and smoking status at 12 months. Potential mediators assessed included access to care, health and stroke literacy, self-efficacy, perceptions of care, and BP monitor use. Results Among 487 participants included, the mean (SD) age was 57.1 (8.9) years; 317 (65.1%) were men, and 347 participants (71.3%) were Hispanic, 87 participants (18.3%) were Black, and 30 participants (6.3%) were Asian. A total of 246 participants were randomized to usual care, and 241 participants were randomized to the intervention. Mean (SD) systolic BP improved from 143 (17) mm Hg at baseline to 133 (20) mm Hg at 12 months in the intervention group and from 146 (19) mm Hg at baseline to 137 (22) mm Hg at 12 months in the usual care group, with no significant differences in the change between groups. Compared with the control group, participants in the intervention group had greater improvements in self-reported salt intake (difference, 15.4 [95% CI, 4.4 to 26.0]; P = .004) and serum CRP level (difference in log CRP, -0.4 [95% CI, -0.7 to -0.1] mg/dL; P = .003); there were no differences in other secondary outcomes. Although 216 participants (89.6%) in the intervention group received some of the 3 core components, only 35 participants (14.5%) received the intended full dose. Conclusions and Relevance This randomized clinical trial of a complex multilevel, multimodal intervention did not find vascular risk factor improvements beyond that of usual care; however, further studies may consider testing the SUCCEED intervention with modifications to enhance implementation and participant engagement. Trial Registration ClinicalTrials.gov Identifier: NCT01763203.",2021,"Compared with the control group, participants in the intervention group had greater improvements in self-reported salt intake (difference, 15.4 [95% CI, 4.4 to 26.0];","['Inclusion criteria were age 40 years or older', 'February 2014 to September 2018, and data were analyzed from October 2018 to November 2020', '487 participants included', 'participants recruited from 5 hospitals serving low-income populations in Los Angeles County, California, as part of the Secondary Stroke Prevention by Uniting Community and Chronic Care Model Teams Early to End Disparities (SUCCEED) clinical trial', '246 participants were randomized to usual care, and 241 participants', 'mean (SD) age was 57.1 (8.9) years; 317 (65.1%) were men, and 347 participants (71.3%) were Hispanic, 87 participants (18.3%) were Black, and 30 participants (6.3%) were Asian', 'Patients With Stroke or Transient Ischemic Attack', '887 individuals screened for eligibility, 542 individuals were eligible, and 487 individuals were enrolled and randomized, stratified by stroke type (ischemic or TIA vs hemorrhagic), language (English vs Spanish), and site to usual care vs intervention in a 1:1 fashion']","['physician team intervention', 'control group received usual care, which varied by site but frequently included a free BP monitor, self-management tools, and linguistically tailored information materials', 'Coordinated Community and Chronic Care Model Team Intervention vs Usual Care', 'transient ischemic attack (TIA', 'multimodal coordinated care intervention, including hypothesized core components (ie, ≥3 APC clinic visits, ≥3 CHW home visits, and Chronic Disease Self-Management Program workshops), and additional telephone visits, protocol-driven risk factor management, culturally and linguistically tailored education materials, and self-management tools']","['Systolic Blood Pressure', 'change in systolic BP', 'non-high density lipoprotein cholesterol, hemoglobin A1c, and C-reactive protein (CRP) levels, body mass index, antithrombotic adherence, physical activity level, diet, and smoking status at 12 months', 'Mean (SD) systolic BP', 'serum CRP level', 'care, health and stroke literacy, self-efficacy, perceptions of care, and BP monitor use', 'systolic blood pressure (BP', 'self-reported salt intake']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0024045', 'cui_str': 'Low Income Population'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1277289', 'cui_str': 'Stroke prevention'}, {'cui': 'C0166872', 'cui_str': 'Unite resin'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0005825', 'cui_str': 'Sphygmomanometers, Continuous'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1277266', 'cui_str': 'Serum C reactive protein level'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0005825', 'cui_str': 'Sphygmomanometers, Continuous'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",246.0,0.139094,"Compared with the control group, participants in the intervention group had greater improvements in self-reported salt intake (difference, 15.4 [95% CI, 4.4 to 26.0];","[{'ForeName': 'Amytis', 'Initials': 'A', 'LastName': 'Towfighi', 'Affiliation': 'University of Southern California, Los Angeles.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Cheng', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Ayala-Rivera', 'Affiliation': 'University of Southern California, Los Angeles.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Barry', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'McCreath', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Ganz', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Martin L', 'Initials': 'ML', 'LastName': 'Lee', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Nerses', 'Initials': 'N', 'LastName': 'Sanossian', 'Affiliation': 'University of Southern California, Los Angeles.'}, {'ForeName': 'Bijal', 'Initials': 'B', 'LastName': 'Mehta', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Dutta', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, California.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Razmara', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, California.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bryg', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Shlee S', 'Initials': 'SS', 'LastName': 'Song', 'Affiliation': 'Cedars Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Phyllis', 'Initials': 'P', 'LastName': 'Willis', 'Affiliation': 'Watts Labor Community Action Committee, Los Angeles, California.'}, {'ForeName': 'Shinyi', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'University of Southern California, Los Angeles.'}, {'ForeName': 'Magaly', 'Initials': 'M', 'LastName': 'Ramirez', 'Affiliation': 'University of Washington School of Public Health, Seattle.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Richards', 'Affiliation': 'Community Partners International, San Francisco, California.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Jackson', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Wacksman', 'Affiliation': 'Dimagi, Cambridge, Massachusetts.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Mittman', 'Affiliation': 'Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, California.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Tran', 'Affiliation': 'Harbor-UCLA Medical Center, Torrance, California.'}, {'ForeName': 'Renee R', 'Initials': 'RR', 'LastName': 'Johnson', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, California.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Ediss', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, California.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Sivers-Teixeira', 'Affiliation': 'University of Southern California, Los Angeles.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Shaby', 'Affiliation': 'Olive View-UCLA Medical Center, Sylmar, California.'}, {'ForeName': 'Ana L', 'Initials': 'AL', 'LastName': 'Montoya', 'Affiliation': 'Harbor-UCLA Medical Center, Torrance, California.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Corrales', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, California.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Mojarro-Huang', 'Affiliation': 'University of Southern California, Los Angeles.'}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, California.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Gomez', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, California.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Muñoz', 'Affiliation': 'University of Southern California, Los Angeles.'}, {'ForeName': 'Diamond', 'Initials': 'D', 'LastName': 'Garcia', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, California.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Moreno', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, California.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Fernandez', 'Affiliation': 'University of Southern California, Los Angeles.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Lopez', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, California.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Valdez', 'Affiliation': 'Harbor-UCLA Medical Center, Torrance, California.'}, {'ForeName': 'Hilary R', 'Initials': 'HR', 'LastName': 'Haber', 'Affiliation': 'Dimagi, Cambridge, Massachusetts.'}, {'ForeName': 'Valerie A', 'Initials': 'VA', 'LastName': 'Hill', 'Affiliation': 'University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Neal M', 'Initials': 'NM', 'LastName': 'Rao', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Martinez', 'Affiliation': 'University of Southern California, Los Angeles.'}, {'ForeName': 'Lillie', 'Initials': 'L', 'LastName': 'Hudson', 'Affiliation': 'University of Southern California, Los Angeles.'}, {'ForeName': 'Natalie P', 'Initials': 'NP', 'LastName': 'Valle', 'Affiliation': 'St Jude Medical Center, Fullerton, California.'}, {'ForeName': 'Barbara G', 'Initials': 'BG', 'LastName': 'Vickrey', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA network open,['10.1001/jamanetworkopen.2020.36227'] 2194,33619579,Evaluation of a group family-based intervention programme for adolescent obesity: the LITE randomised controlled pilot trial.,"INTRODUCTION This study aimed to evaluate the LITE (Lifestyle Intervention for TEenagers) group programme, a family-based behavioural lifestyle intervention for overweight and obese adolescents. METHODS We conducted a two-arm randomised controlled trial that recruited overweight and obese adolescents who attended a tertiary care weight management clinic. Participants were randomised to the LITE programme or usual care. The primary outcome assessed was body mass index (BMI) z-score. Secondary outcomes of anthropometric measurements, metabolic profile, parenting and adolescents' perception of family support were measured at baseline, three months and six months. Feasibility and acceptability of the LITE programme were also evaluated. RESULTS 61 adolescents were enrolled, with 31 in the LITE programme and 30 in usual care. At three months, participants in the programme had a greater reduction in weight (-0.18 ± 2.40 kg vs. 1.48 ± 1.97 kg; p = 0.107), waist circumference (-1.0 ± 3.1 cm vs. 2.4 ± 2.7 cm; p = 0.016), waist-height ratio (-0.01 ± 0.02 vs. 0.01 ± 0.02; p = 0.040) and systolic blood pressure (-3.8 ± 13.7 vs. 5.7 ± 13.1; p = 0.119) compared to the usual care group. There was no significant difference in BMI z-score. At six months, there were significant improvements in adolescents' perception of family support for eating habits in the LITE group compared to the usual care group. The LITE programme had a good attendance rate of 67.7% and was well received. CONCLUSION The LITE programme showed feasibility and short-term clinical effectiveness in improving some clinical outcomes and improved adolescents' perception of family support.",2021,"At six months, there were significant improvements in adolescents' perception of family support for eating habits in the LITE group compared to the usual care group.","['61 adolescents were enrolled, with 31 in the LITE programme and 30 in usual care', 'adolescent obesity', 'recruited overweight and obese adolescents who attended a tertiary care weight management clinic', 'overweight and obese adolescents']","['LITE programme or usual care', 'LITE (Lifestyle Intervention for TEenagers) group programme, a family-based behavioural lifestyle intervention', 'group family-based intervention programme']","['body mass index (BMI) z-score', 'Feasibility and acceptability', 'reduction in weight', 'systolic blood pressure', ""adolescents' perception of family support"", 'BMI z-score', ""anthropometric measurements, metabolic profile, parenting and adolescents' perception of family support"", ""adolescents' perception of family support for eating habits"", 'waist circumference', 'waist-height ratio', 'good attendance rate']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4317171', 'cui_str': 'Obesity in Adolescence'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0150232', 'cui_str': 'Family support'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0016468', 'cui_str': 'Eating Habits'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C1821269', 'cui_str': 'Waist to Height Ratio'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]",61.0,0.0767689,"At six months, there were significant improvements in adolescents' perception of family support for eating habits in the LITE group compared to the usual care group.","[{'ForeName': 'Chu Shan Elaine', 'Initials': 'CSE', 'LastName': 'Chew', 'Affiliation': ""Adolescent Medicine Service, KK Women's and Children's Hospital, Singapore.""}, {'ForeName': 'Jean Yin', 'Initials': 'JY', 'LastName': 'Oh', 'Affiliation': ""Adolescent Medicine Service, KK Women's and Children's Hospital, Singapore.""}, {'ForeName': 'Kumudhini', 'Initials': 'K', 'LastName': 'Rajasegaran', 'Affiliation': ""Adolescent Medicine Service, KK Women's and Children's Hospital, Singapore.""}, {'ForeName': 'Seyed Ehsan', 'Initials': 'SE', 'LastName': 'Saffari', 'Affiliation': 'Centre for Quantitative Medicine, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Chee Ming Micheal', 'Initials': 'CMM', 'LastName': 'Lim', 'Affiliation': ""Family Medicine Service, KK Women's and Children's Hospital, Singapore.""}, {'ForeName': 'Siew Choo', 'Initials': 'SC', 'LastName': 'Lim', 'Affiliation': ""Department of Nutrition and Dietetics, KK Women's and Children's Hospital, Singapore.""}, {'ForeName': 'Shiling', 'Initials': 'S', 'LastName': 'Tan', 'Affiliation': ""Department of Nutrition and Dietetics, KK Women's and Children's Hospital, Singapore.""}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Kelly', 'Affiliation': ""Psychology Service, KK Women's and Children's Hospital, Singapore.""}]",Singapore medical journal,['10.11622/smedj.2019122'] 2195,33620447,Effectiveness of Internet-Based Exercises Aimed at Treating Knee Osteoarthritis: The iBEAT-OA Randomized Clinical Trial.,"Importance Osteoarthritis is a prevalent, debilitating, and costly chronic disease for which recommended first-line treatment is underused. Objective To compare the effect of an internet-based treatment for knee osteoarthritis vs routine self-management (ie, usual care). Design, Setting, and Participants This randomized clinical trial was conducted from October 2018 to March 2020. Participants included individuals aged 45 years or older with a diagnosis of knee osteoarthritis recruited from an existing primary care database or from social media advertisements were invited. Data were analyzed April to July 2020. Interventions The intervention and control group conformed to first-line knee osteoarthritis treatment. For the intervention group, treatment was delivered via a smartphone application. The control group received routine self-management care. Main Outcomes and Measures The primary outcome was change from baseline to 6 weeks in self-reported pain during the last 7 days, reported on a numerical rating scale (NRS; range, 0-10, with 0 indicating no pain and 10, worst pain imaginable), compared between groups. Secondary outcomes included 2 physical functioning scores, hamstring and quadriceps muscle strength, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and quantitative sensory testing. Results Among a total of 551 participants screened for eligibility, 146 were randomized and 105 were analyzed (mean [SD] age, 66.7 [9.2] years, 71 [67.1%] women), including 48 participants in the intervention group and 57 participants in the control group. There were no significant differences in baseline characteristics between the groups. At the 6-week follow-up, the intervention group showed a greater NRS pain score reduction than the control group (between-group difference, -1.5 [95% CI, -2.2 to -0.8]; P < .001). Similarly, the intervention group had better improvements in the 30-second sit-to-stand test (between-group difference, 3.4 [95% CI, 2.2 to 4.5]; P < .001) and Timed Up-and-Go test (between-group difference, -1.8 [95% CI, -3.0 to -0.5] seconds; P = .007), as well as the WOMAC subscales for pain (between-group difference, -1.1 [95% CI, -2.0 to -0.2]; P = .02), stiffness (between-group difference, -1.0 [95% CI, -1.5 to -0.5]; P < .001), and physical function (between-group difference, -3.4 [95% CI, -6.2 to -0.7]; P = .02). The magnitude of within-group changes in pain (d = 0.83) and function outcomes (30 second sit-to-stand test d = 1.24; Timed Up-and-Go test d = 0.76) in the intervention group corresponded to medium to very strong effects. No adverse events were reported. Conclusions and Relevance These findings suggest that this internet-delivered, evidence-based, first-line osteoarthritis treatment was superior to routine self-managed usual care and could be provided without harm to people with osteoarthritis. Effect sizes observed in the intervention group corresponded to clinically important improvements. Trial Registration ClinicalTrials.gov Identifier: NCT03545048.",2021,"At the 6-week follow-up, the intervention group showed a greater NRS pain score reduction than the control group (between-group difference, -1.5 [95% CI, -2.2 to -0.8]; P < .001).","['October 2018 to March 2020', 'Participants included individuals aged 45 years or older with a diagnosis of knee osteoarthritis recruited from an existing primary care database or from social media advertisements were invited', 'Knee Osteoarthritis', '551 participants screened for eligibility, 146 were randomized and 105 were analyzed (mean [SD] age, 66.7 [9.2] years, 71 [67.1%] women), including 48 participants in the intervention group and 57 participants in the control group']","['routine self-management care', 'control group conformed to first-line knee osteoarthritis treatment', 'internet-based treatment for knee osteoarthritis vs routine self-management (ie, usual care', 'Internet-Based Exercises']","['change from baseline to 6 weeks in self-reported pain', 'physical function', 'NRS pain score reduction', 'function outcomes', '2 physical functioning scores, hamstring and quadriceps muscle strength, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and quantitative sensory testing', 'numerical rating scale (NRS; range, 0-10, with 0 indicating no pain and 10, worst pain imaginable', '30-second sit-to-stand test', 'adverse events', 'pain', 'WOMAC subscales for pain']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517843', 'cui_str': '66.7'}, {'cui': 'C5191219', 'cui_str': '9.2'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0430838', 'cui_str': 'Quantitative sensory test'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",2.0,0.119671,"At the 6-week follow-up, the intervention group showed a greater NRS pain score reduction than the control group (between-group difference, -1.5 [95% CI, -2.2 to -0.8]; P < .001).","[{'ForeName': 'Sameer Akram', 'Initials': 'SA', 'LastName': 'Gohir', 'Affiliation': 'National Institute for Health Research, Nottingham Biomedical Research Centre, School of Medicine, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Frida', 'Initials': 'F', 'LastName': 'Eek', 'Affiliation': 'Department of Health Sciences, Lund University, Lund University, Sweden.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Kelly', 'Affiliation': 'National Institute for Health Research, Nottingham Biomedical Research Centre, School of Medicine, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Abhishek', 'Affiliation': 'National Institute for Health Research, Nottingham Biomedical Research Centre, School of Medicine, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Valdes', 'Affiliation': 'National Institute for Health Research, Nottingham Biomedical Research Centre, School of Medicine, University of Nottingham, Nottingham, United Kingdom.'}]",JAMA network open,['10.1001/jamanetworkopen.2021.0012'] 2196,30102683,Endothelial Vasodilation After a High-Volume Training Load and Tapered Training in Collegiate Female Swimmers.,"ABSTRACT Weihl, FM and Van Guilder, GP. Endothelial vasodilation after a high-volume training load and tapered training in collegiate female swimmers. J Strength Cond Res 35(3): 811-818, 2021-High-volume endurance training loads have been linked to adverse remodeling of the heart and large arteries; yet, data on the vascular endothelial function are unclear. Moreover, although collegiate-level endurance athletes often perform high-volumes of vigorous endurance training and resistance training as part of their strength and conditioning programs, it is unknown whether they also experience vascular abnormalities, particularly changes in endothelial function. The aim of this study was to verify the impact of a high-volume training load phase followed by low-volume tapered training on endothelial vasodilator function in National Collegiate Athletic Association (NCAA) Division I competitive female swimmers. Microvascular endothelial vasodilation was assessed by pulse arterial tonometry that provides a reactive hyperemia index in 10 female NCAA Division 1 swimmers after 4 weeks of a high-volume training load, and subsequently, after 3 weeks of low-volume tapered training as part of preparation for annual conference championships. The reactive hyperemia index was calculated as the ratio of the pulse volume amplitude after 5 minutes of left-arm brachial artery ischemia to the baseline amplitude, divided by same ratio in the contralateral arm. The high-volume training load included a 4-week block of dual-day sessions (120 minutes per practice) consisting of vigorous intensity endurance and high-intensity interval/sprint swim training, coupled with 5K running, resistance training, and Olympic weightlifting. Tapered training consisted of 3 weeks of 3-5 swims per week at ∼50% V̇o2max for 60 minutes per practice (∼4,000 minutes per practice). The reactive hyperemia index (1.73 ± 0.50) was low in athletes after the high-volume training load with 8 athletes demonstrating endothelial dysfunction. However, after tapered training, the reactive hyperemia index was ∼33% higher (2.29 ± 0.43; 95% confidence interval [CI]: 1.98-2.60, p = 0.0223 vs. the high-volume training load). Effect size, as expressed by the partial eta2 (0.46) and Cohen's dz (1.1923; 95% CI: 0.1687-2.4643) with tapered training, was large. These results demonstrate distinct differences in endothelial vasodilation after 4 weeks of a high-volume training load compared with a 3-week taper in NCAA Division I female swimmers.",2021,The reactive hyperemia index (1.73 ± 0.50) was low in athletes after the high-volume training load with 8 athletes demonstrating endothelial dysfunction.,"['Collegiate Female Swimmers', 'I competitive female swimmers', 'J Strength Cond Res 35(3', 'I female swimmers', 'National Collegiate Athletic Association (NCAA', 'collegiate female swimmers']","['NCAA Division', 'vigorous intensity endurance and high-intensity interval/sprint swim training, coupled with 5K running, resistance training, and Olympic weightlifting', 'Division', 'high-volume training load phase followed by low-volume tapered training']","['reactive hyperemia index', 'Microvascular endothelial vasodilation', 'Endothelial Vasodilation', 'endothelial vasodilation', 'Endothelial vasodilation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0450068', 'cui_str': 'Swimmer'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0004083', 'cui_str': 'Association'}]","[{'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}]","[{'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}]",,0.0247808,The reactive hyperemia index (1.73 ± 0.50) was low in athletes after the high-volume training load with 8 athletes demonstrating endothelial dysfunction.,"[{'ForeName': 'Fawn M', 'Initials': 'FM', 'LastName': 'Weihl', 'Affiliation': 'Vascular Protection Research Laboratory, Department of Health & Nutritional Sciences, South Dakota State University, Brookings, South Dakota.'}, {'ForeName': 'Gary P', 'Initials': 'GP', 'LastName': 'Van Guilder', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002769'] 2197,33587381,Prior Botulinum Toxin Treatment Does Not Impact Efficacy or Safety in Clinical Trials: Analysis of DaxibotulinumtoxinA for Injection in the SAKURA Program.,"BACKGROUND Pivotal studies of approved botulinum toxin type A (BoNTA) formulations for treatment of glabellar lines have mostly included treatment-naive participants, and the impact of prior BoNTA treatment on efficacy and safety is not well documented. OBJECTIVE To evaluate whether prior BoNTA treatment affects efficacy, duration of response, and tolerability for treatment of glabellar lines. METHODS Adults with moderate or severe glabellar lines treated with DaxibotulinumtoxinA for Injection (DAXI) or placebo from the randomized, double-blind SAKURA 1/2 trials and the open-label SAKURA 3 safety study were analyzed by prior BoNTA treatment status. Efficacy was evaluated using investigator and participant assessments. RESULTS In this analysis, 609 participants (52.2% BoNTA-experienced) from the SAKURA 1/2 trials and 2,380 (38.0% BoNTA-experienced) from the SAKURA 3 study were evaluated. Proportion of participants with none or mild glabellar lines and duration of response were similar between the BoNTA-naive and BoNTA-experienced cohorts in both the DAXI and placebo groups. The incidence of adverse events was also comparable regardless of prior BoNTA treatment status. CONCLUSION Efficacy and tolerability were similar with DAXI and placebo regardless of prior BoNTA treatment. Assuming an appropriate washout is observed, future BoNTA trials should enroll both treatment-experienced and treatment-naive participants to reflect clinical practice.",2021,Proportion of participants with none or mild glabellar lines and duration of response were similar between the BoNTA-naive and BoNTA-experienced cohorts in both the DAXI and placebo groups.,"['Adults with moderate or severe glabellar lines treated with', '609 participants (52.2% BoNTA-experienced) from the SAKURA 1/2 trials and 2,380 (38.0% BoNTA-experienced) from the SAKURA 3 study were evaluated']","['Botulinum Toxin Treatment', 'DaxibotulinumtoxinA for Injection (DAXI) or placebo', 'DAXI and placebo', 'botulinum toxin type A (BoNTA) formulations', 'DaxibotulinumtoxinA']","['Efficacy', 'Efficacy and tolerability', 'efficacy, duration of response, and tolerability', 'mild glabellar lines and duration of response', 'adverse events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0442019', 'cui_str': 'Glabellar'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4517801', 'cui_str': '52.2'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0006055', 'cui_str': 'botulinum toxin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0442019', 'cui_str': 'Glabellar'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",3.0,0.179842,Proportion of participants with none or mild glabellar lines and duration of response were similar between the BoNTA-naive and BoNTA-experienced cohorts in both the DAXI and placebo groups.,"[{'ForeName': 'Joel L', 'Initials': 'JL', 'LastName': 'Cohen', 'Affiliation': 'AboutSkin Dermatology and DermSurgery PC, Greenwood Village, Colorado.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Green', 'Affiliation': 'Department of Dermatology, George Washington University School of Medicine, Washington, District of Columbia.'}, {'ForeName': 'Kenneth R', 'Initials': 'KR', 'LastName': 'Beer', 'Affiliation': 'Beer Dermatology, West Palm Beach, Florida.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Revance Therapeutics, Inc., Newark, California.'}, {'ForeName': 'Conor J', 'Initials': 'CJ', 'LastName': 'Gallagher', 'Affiliation': 'Revance Therapeutics, Inc., Newark, California.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002877'] 2198,33587369,"A Randomized, Controlled, Evaluator-Blinded, Multi-Center Study of Hyaluronic Acid Filler Effectiveness and Safety in Lip Fullness Augmentation.","BACKGROUND HARK was recently approved in the US for lip augmentation and correction of upper perioral rhytids. OBJECTIVE To demonstrate noninferiority of HARK versus a control (HAJV) in lip fullness augmentation at Week 8 after last injection (blinded evaluation). Secondary objectives were to evaluate the effectiveness and safety of HARK in lip fullness augmentation and correction of upper perioral rhytids. METHODS AND MATERIALS Treatment with HARK or control (randomized 2:1) was administered on Day 1 in this 48-week, evaluator-blinded study with optional touch-up at Week 4. Primary endpoint was change from baseline to Week 8 in lip fullness. Secondary endpoints included lip fullness, wrinkle severity, aesthetic improvement, subject satisfaction, adverse events, and local tolerability (subject diary entries). RESULTS The primary objective was met; HARK was noninferior to control in lip fullness augmentation at Week 8. Lip fullness and wrinkle severity improvement persisted at Week 48, and was accompanied by high aesthetic improvement and subject satisfaction scores. The mean volume of HARK injected was approximately 20% lower than control. Treatment-related adverse events and local tolerability symptoms were predominantly mild and transient. CONCLUSION HARK was noninferior to control in lip fullness augmentation at Week 8, well-tolerated, and effective throughout this 48-week study.",2021,"Secondary endpoints included lip fullness, wrinkle severity, aesthetic improvement, subject satisfaction, adverse events, and local tolerability (subject diary entries). ",['Lip Fullness Augmentation'],"['Hyaluronic Acid', 'HARK', 'HARK versus a control (HAJV']","['lip fullness, wrinkle severity, aesthetic improvement, subject satisfaction, adverse events, and local tolerability (subject diary entries', 'aesthetic improvement and subject satisfaction scores', 'Lip fullness and wrinkle severity improvement', 'adverse events and local tolerability symptoms', 'change from baseline to Week 8 in lip fullness', 'mean volume of HARK', 'effectiveness and safety of HARK in lip fullness augmentation and correction of upper perioral rhytids']","[{'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}]","[{'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0277938', 'cui_str': 'Circumoral rhytides'}]",,0.103697,"Secondary endpoints included lip fullness, wrinkle severity, aesthetic improvement, subject satisfaction, adverse events, and local tolerability (subject diary entries). ","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Weiss', 'Affiliation': 'Maryland Dermatology, Laser, Skin and Vein Institute, Hunt Valley, Maryland.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Beer', 'Affiliation': 'Research Institute of SouthEast, West Palm Beach, Florida.'}, {'ForeName': 'Sue E', 'Initials': 'SE', 'LastName': 'Cox', 'Affiliation': 'Aesthetic Solutions, Chapel Hill, North Carolina.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Palm', 'Affiliation': 'Art of Skin Maryland, Solana Beach, California.'}, {'ForeName': 'Joely', 'Initials': 'J', 'LastName': 'Kaufman-Janette', 'Affiliation': 'Skin Research Institute, LLC, Coral Gables, Florida.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Bassichis', 'Affiliation': 'Center for Advanced Clinical Research, Dallas, Texas.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Biesman', 'Affiliation': 'Brian S. Biesman, Nashville, Tennessee.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Joseph', 'Affiliation': 'Clinical Testing of Beverly Hills, Encino, California.'}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Almegård', 'Affiliation': 'Galderma Aesthetics, Clinical Development, Uppsala, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Nilsson', 'Affiliation': 'Galderma Aesthetics, Clinical Development, Uppsala, Sweden.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Edwartz', 'Affiliation': 'Galderma Aesthetics, Global Medical Affairs, Uppsala, Sweden.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002856'] 2199,33820488,A quasi-experimental study of specialized training on the clinical decision-making skills and social problem-solving abilities of nursing students.,"Background: In Asian countries, clinical practice places little emphasis on developing the clinical decision-making skills and social problem-solving abilities of nursing students. Objective: This study explored whether a 3-months-in-1-unit training program improved nursing students' clinical decision-making skills and social problem-solving abilities compared to the 1-month-in-1-unit rotation program. Methods: A quasi-experimental study was conducted. A 3-months-in-1-unit training program was conducted in the intervention group ( n  = 77), rountine1-month-in-1-unit rotation was conducted in the control group ( n  = 73). Clinical decision-making skills and problem-solving abilities were measured using the Chinese version of the Clinical Decision-Making Nursing Scale and the Social Problem-Solving Inventory-Revised. Results: Nursing students in the intervention group scored higher clinical decision-making skills ( t  = 7.677, p  < 0.05), positive problem orientation ( t  = 18.359, p  < 0.05), negative problem orientation ( t  = -3.711, p  < 0.05), and rational problem-solving ( t  = 2.312, p  < 0.05) than the control group. Conclusions: The 3-months-in-1-unit specialized training program had a significant positive impact on students' clinical decision-making skills and social problem-solving abilities.",2021,"No significant differences in nursing students' clinical decision-making skills or social problem-solving abilities existed between the intervention group and control group pre-intervention; compared to the standard 1-month-in-1-unit rotation program, the 3-months-in-1-unit specialized training program had a significant positive impact on students' clinical decision-making skills and social problem-solving abilities. ","['nursing students', '150 nursing students were recruited (77 in intervention group, 73 in control group), of which 137 (91.30%) were female, mean age was 21.21 years ( SD =0.97', 'comprehensive hospital in China']","['specialized training', '3-months-in-1-unit specialized training program']","[""nursing students' clinical decision-making skills or social problem-solving abilities"", ""students' clinical decision-making skills and social problem-solving abilities"", 'clinical decision-making skills', 'positive problem orientation', 'clinical decision-making skills and social problem-solving abilities', 'social problem-solving abilities', 'negative problem orientation']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C4042877', 'cui_str': 'Medical Decision-Making'}, {'cui': 'C0037431', 'cui_str': 'Social problem'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",150.0,0.00820695,"No significant differences in nursing students' clinical decision-making skills or social problem-solving abilities existed between the intervention group and control group pre-intervention; compared to the standard 1-month-in-1-unit rotation program, the 3-months-in-1-unit specialized training program had a significant positive impact on students' clinical decision-making skills and social problem-solving abilities. ","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""Nursing Department, Shandong Provincial Hospital, Shandong First Medical University, Jinan, Shandong, People's Republic of China.""}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Kong', 'Affiliation': ""Nursing Department, Shandong Provincial Hospital, Shandong First Medical University, Jinan, Shandong, People's Republic of China.""}, {'ForeName': 'Shufang', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Shandong University of Traditional Chinese Medicine, Jinan, Shandong, Chian.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""Nursing Department, Shandong Provincial Hospital, Shandong First Medical University, Jinan, Shandong, People's Republic of China.""}]",Contemporary nurse,['10.1080/10376178.2021.1912616'] 2200,33587505,"Feasibility and Successful Enrollment in a Proof-of-Concept HIV Prevention Trial of VRC01, a Broadly Neutralizing HIV-1 Monoclonal Antibody.","BACKGROUND The Antibody-Mediated Prevention trials (HVTN 704/HPTN 085 and HVTN 703/HPTN 081) are the first efficacy trials to evaluate whether VRC01, a broadly neutralizing monoclonal antibody targeting the CD4-binding site of the HIV envelope protein, prevents sexual transmission of HIV-1. HVTN 704/HPTN 085 enrolled 2701 cisgender men and transgender (TG) individuals who have sex with men at 26 sites in Brazil, Peru, Switzerland, and the United States. METHODS Participants were recruited and retained through early, extensive community engagement. Eligible participants were randomized 1:1:1 to 10 mg/kg or 30 mg/kg of VRC01 or saline placebo. Visits occurred monthly, with intravenous (IV) infusions every 8 weeks over 2 years, for a total of 10 infusions. Participants were followed for 104 weeks after first infusion. RESULTS The median HVTN 704/HPTN 085 participant age was 28 years; 99% were assigned male sex; 90% identified as cisgender men, 5% as TG women and the remaining as other genders. Thirty-two percent were White, 15% Black, and 57% Hispanic/Latinx. Twenty-eight percent had a sexually transmitted infection at enrollment. More than 23,000 infusions were administered with no serious IV administration complications. Overall, retention and adherence to the study schedule exceeded 90%, and the dropout rate was below 10% annually (7.3 per 100 person-years) through week 80, the last visit for the primary end point. CONCLUSIONS HVTN 704/HPTN 085 exceeded accrual and retention expectations. With exceptional safety of IV administration and operational feasibility, it paves the way for future large-scale monoclonal antibody trials for HIV prevention and/or treatment.",2021,"Overall retention and adherence to the study schedule exceeded 90%, and the drop-out rate was below 10% annually (7.3 per 100-person years) through Week 80, the last visit for the primary endpoint. ","['The median HVTN 704/HPTN 085 participant age was 28; 99% were assigned male sex; 90% identified as cisgender male, 5% as TG female and the remaining as other genders', 'Twenty-eight percent had a sexually transmitted infection at enrollment', 'Participants were recruited and retained through early, extensive community engagement', 'Thirty-two percent were White, 15% Black and 57', 'HVTN 704/HPTN 085 enrolled 2,701 cisgender men and transgender (TG) individuals who have sex with men at 26 sites in Brazil, Peru, Switzerland and the United States', 'Eligible participants']","['HVTN', 'VRC01 or saline placebo']",['Overall retention and adherence'],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",2701.0,0.166727,"Overall retention and adherence to the study schedule exceeded 90%, and the drop-out rate was below 10% annually (7.3 per 100-person years) through Week 80, the last visit for the primary endpoint. ","[{'ForeName': 'Srilatha', 'Initials': 'S', 'LastName': 'Edupuganti', 'Affiliation': 'Division of Infectious Disease, Department of Medicine, Emory University, Atlanta, GA.'}, {'ForeName': 'Nyaradzo', 'Initials': 'N', 'LastName': 'Mgodi', 'Affiliation': 'University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe.'}, {'ForeName': 'Shelly T', 'Initials': 'ST', 'LastName': 'Karuna', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Andrew', 'Affiliation': 'Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Rudnicki', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Kochar', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'deCamp', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'De La Grecca', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Maija', 'Initials': 'M', 'LastName': 'Anderson', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Carissa', 'Initials': 'C', 'LastName': 'Karg', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'India', 'Initials': 'I', 'LastName': 'Tindale', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Greene', 'Affiliation': 'Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Gail B', 'Initials': 'GB', 'LastName': 'Broder', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Lucas', 'Affiliation': 'Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hural', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Gallardo-Cartagena', 'Affiliation': 'Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos, Lima, Peru.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Gonzales', 'Affiliation': 'Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo, Lima.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Frank', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Pennsylvania, Pennsylvania, PA.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Sobieszczyk', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, Columbia University, New York, NY.'}, {'ForeName': 'Margarita M', 'Initials': 'MM', 'LastName': 'Gomez Lorenzo', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Burns', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Anderson', 'Affiliation': 'Department of Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Maurine D', 'Initials': 'MD', 'LastName': 'Miner', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Ledgerwood', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD; and.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Mascola', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD; and.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Gilbert', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Myron S', 'Initials': 'MS', 'LastName': 'Cohen', 'Affiliation': 'Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Corey', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002639'] 2201,33588770,Rapid component of excess post-exercise oxygen consumption of children of different weight status after playing active video games.,"BACKGROUND Excess post-exercise oxygen consumption (EPOC) of children could indicate the potential of an exercise therapy to treat or prevent obesity. However, EPOC as a result of playing active video games (AVG) has been poorly investigated. Therefore, we aimed to investigate the rapid component of EPOC of children with healthy weight and overweight/obesity (according to their BMI percentile) after playing AVGs that feature predominately upper body (UB) and whole-body (WB) movement. METHODS Twenty-one children with healthy weight (BMI percentile < 85%) and with overweight/obesity (BMI percentile ≥ 85%) randomly underwent two 10-min AVG sessions (UB and WB). The heart rate (HR), minute ventilation (VE), oxygen consumption (VO 2 ) and carbon dioxide production (VCO 2 ) were recorded during exercise and post-exercise recovery period. For the rapid component of EPOC in each AVG session, measurements were recorded every 15 s for 5-min of post-exercise recovery. The rate of perceived exertion (RPE) was also measured immediately before and after each AVG play. RESULTS Children with overweight/obesity had a higher average of absolute VE, VO 2 , and VCO 2 than their healthy-weight counterparts (BMI percentile < 85%; n = 21) during post-exercise recovery. RPE, HR, and HR% were not different between the game sessions and weight groups. Children with overweight/obesity showed a higher absolute VO 2 during EPOC than healthy-weight children in both game sessions, but relative VO 2 was higher in healthy-weight children during EPOC. No differences were observed for EPOC between UB and WB sessions. CONCLUSIONS Children with overweight/obesity had a greater EPOC than healthy-weight children after AVG sessions in terms of absolute oxygen values, whereas healthy-weight children have higher EPOC considering relative VO 2 when controlling for body mass. UB and WB AVGs induced a similar EPOC among children with healthy weight and overweight/obesity. As UB and WB AVGs induce the rapid component of EPOC in children regardless their weight status, AVGs could be used as an exercise method to treat and prevent child obesity.",2021,"Children with overweight/obesity showed a higher absolute VO 2 during EPOC than healthy-weight children in both game sessions, but relative VO 2 was higher in healthy-weight children during EPOC.","['children of different weight status after playing active video games', 'children with healthy weight and overweight/obesity (according to their BMI percentile) after playing AVGs that feature predominately upper body (UB) and whole-body (WB) movement', 'Children with overweight/obesity', 'Twenty-one children with healthy weight (BMI percentile\xa0<\u200985%) and with overweight/obesity (BMI percentile\xa0≥\xa085%) randomly underwent', 'children with healthy weight and overweight/obesity']","['Excess post-exercise oxygen consumption (EPOC', 'two 10-min AVG sessions (UB and WB']","['heart rate (HR), minute ventilation (VE), oxygen consumption (VO 2 ) and carbon dioxide production (VCO 2 ', 'RPE, HR, and HR', 'rate of perceived exertion (RPE']","[{'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332251', 'cui_str': 'Predominate'}, {'cui': 'C1268087', 'cui_str': 'Upper body structure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0280558', 'cui_str': 'COPE regimen'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C1268087', 'cui_str': 'Upper body structure'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",21.0,0.0296125,"Children with overweight/obesity showed a higher absolute VO 2 during EPOC than healthy-weight children in both game sessions, but relative VO 2 was higher in healthy-weight children during EPOC.","[{'ForeName': 'Caio Victor', 'Initials': 'CV', 'LastName': 'Sousa', 'Affiliation': 'Health Technology Lab, College of Arts, Media & Design; Bouvé College of Health Sciences, Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Jungyun', 'Initials': 'J', 'LastName': 'Hwang', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Herbert Gustavo', 'Initials': 'HG', 'LastName': 'Simoes', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasilia, Brasilia, Brazil.'}, {'ForeName': 'Kyung Jin', 'Initials': 'KJ', 'LastName': 'Sun', 'Affiliation': 'Health Technology Lab, College of Arts, Media & Design; Bouvé College of Health Sciences, Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Amy Shirong', 'Initials': 'AS', 'LastName': 'Lu', 'Affiliation': 'Health Technology Lab, College of Arts, Media & Design; Bouvé College of Health Sciences, Northeastern University, Boston, MA, USA. a.lu@northeastern.edu.'}]",BMC pediatrics,['10.1186/s12887-021-02528-z'] 2202,33588088,Amino acids and vitamins status during continuous renal replacement therapy: An ancillary prospective observational study of a randomised control trial.,"BACKGROUND Continuous renal replacement therapy (CRRT) is associated with micronutrients loss. Current recommendations are to administer 1-1.5g/kg/day of proteins during CRRT. We aim to evaluate the net effect of CRRT on amino acids (AA), vitamins A and C (Vit A, Vit C) levels. METHODS This is a prospective observational study embedded within a randomised controlled trial comparing two CRRT doses in patients with septic shock. CRRT was provided in continuous veno-venous haemofiltration mode at a dose of either 35ml/kg/h or 70ml/kg/h. All patients received parenteral nutrition with standard trace elements and vitamins (protein intake 1g/kg/d). We measured serum levels of glutamine, valine and alanine as well as Vit A and Vit C upon randomisation, study day four and eight. In addition, we measured a larger panel of AA in a subset of 11 patients. RESULTS We included 30 patients (17 allocated to 70ml/kg/h and 13 to 35ml/kg/h CRRT). Before CRRT initiation, mean plasma levels of glutamine and valine, Vit A and Vit C were low. CRRT was not associated with any significant change in AA levels except for a decrease in cystein. It was associated with an increase in Vit A and a decrease in Vit C levels. CRRT dose had no impact on those nutrients blood levels. CONCLUSIONS Irrespective of dose, CRRT was associated with a decrease in cysteine and Vit C and an increase in Vit A with no significant change in other AA. Further studies should focus on lean mass wasting during CRRT.",2021,"CONCLUSIONS Irrespective of dose, CRRT was associated with a decrease in cysteine and Vit C and an increase in Vit A with no significant change in other AA.","['30 patients (17 allocated to 70ml/kg/h and 13 to 35ml/kg/h CRRT', 'patients with septic shock']","['CRRT', 'continuous renal replacement therapy', 'parenteral nutrition with standard trace elements and vitamins (protein intake', 'Amino acids and vitamins status', 'Continuous renal replacement therapy (CRRT']","['AA levels', 'amino acids (AA), vitamins A and C', 'cysteine and Vit C', 'serum levels of glutamine, valine and alanine', 'mean plasma levels of glutamine and valine, Vit A and Vit C', 'Vit C levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3649547', 'cui_str': 'Continuous renal replacement therapy'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}]","[{'cui': 'C3649547', 'cui_str': 'Continuous renal replacement therapy'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C1328436', 'cui_str': 'Amino acid level'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0010654', 'cui_str': 'Cysteine'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0042285', 'cui_str': 'Valine'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",30.0,0.133403,"CONCLUSIONS Irrespective of dose, CRRT was associated with a decrease in cysteine and Vit C and an increase in Vit A with no significant change in other AA.","[{'ForeName': 'Antoine G', 'Initials': 'AG', 'LastName': 'Schneider', 'Affiliation': 'Adult Intensive Care Unit and Burn Centre, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland; Faculty of Biology and Medicine, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Picard', 'Affiliation': 'Service de réanimation, Hôpital F. Mitterrand, 4, boulevard Hauterive, 64046 Pau, France.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Honoré', 'Affiliation': 'Intensive Care Department, Centre Hospitalier Universitaire Brugmann-Brugmann University Hospital, Brussels, Belgium.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Dewitte', 'Affiliation': 'CHU de Bordeaux, Service Anesthésie et Réanimation SUD, Centre médico-chirurgical Magellan, Bordeaux, France; Inserm, UMR 1034, Biology of Cardiovascular Diseases, Pessac, France.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Mesli', 'Affiliation': 'CHU de Bordeaux, Hôpital Pellegrin, Département de Biochimie, Bordeaux, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Redonnet-Vernhet', 'Affiliation': 'CHU de Bordeaux, Hôpital Pellegrin, Département de Biochimie, Bordeaux, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Fleureau', 'Affiliation': 'CHU de Bordeaux, Service Anesthésie et Réanimation SUD, Centre médico-chirurgical Magellan, Bordeaux, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Ouattara', 'Affiliation': 'CHU de Bordeaux, Service Anesthésie et Réanimation SUD, Centre médico-chirurgical Magellan, Bordeaux, France; Inserm, UMR 1034, Biology of Cardiovascular Diseases, Pessac, France.'}, {'ForeName': 'Mette M', 'Initials': 'MM', 'LastName': 'Berger', 'Affiliation': 'Adult Intensive Care Unit and Burn Centre, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland; Faculty of Biology and Medicine, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Joannes-Boyau', 'Affiliation': 'CHU de Bordeaux, Service Anesthésie et Réanimation SUD, Centre médico-chirurgical Magellan, Bordeaux, France. Electronic address: olivier.joannes-boyau@chu-bordeaux.fr.'}]","Anaesthesia, critical care & pain medicine",['10.1016/j.accpm.2021.100813'] 2203,33599270,Extensive drug resistance during low-level HIV viraemia while taking NNRTI-based ART supports lowering the viral load threshold for regimen switch in resource-limited settings: a pre-planned analysis from the SESOTHO trial.,"OBJECTIVES WHO guidelines on ART define the HIV-1 viral load (VL) threshold for treatment failure at 1000 copies/mL. The Switch Either near Suppression Or THOusand (SESOTHO) trial, conducted in Lesotho from 2017 to 2020, found that patients with persistent viraemia below this threshold (100-999 copies/mL) benefit from switching to second-line ART. This pre-planned nested study assesses the prevalence of resistance-associated mutations (RAMs) in SESOTHO trial participants. METHODS The SESOTHO trial [registered at ClinicalTrials.gov (NCT03088241)] enrolled 80 persons taking NNRTI-based first-line ART with low-level HIV-1 viraemia (100-999 copies/mL) and randomized them (1:1) to switch to a PI-based second-line regimen (switch) or continue on first-line therapy (control). We sequenced relevant regions of the viral pol gene using plasma samples obtained at enrolment and 36 weeks. RAMs were classified with the Stanford HIV Drug Resistance Database. RESULTS Sequencing data were obtained for 37/80 (46%) participants at baseline and 26/48 (54%) participants without viral suppression to <50 copies/mL at 36 weeks (21 control participants and 5 switch participants). At baseline, 31/37 (84%) participants harboured high-level resistance to at least two drugs of their current regimen. At 36 weeks, 17/21 (81%) control participants harboured resistance to at least two drugs of their current regimen, while no PI-associated resistance was detected in the 5 switch participants with ongoing viraemia. CONCLUSIONS Among persons with low-level viraemia while taking NNRTI-based first-line ART enrolled in the SESOTHO trial, the majority harboured HIV-1 with RAMs that necessitate ART modification. These findings support lowering the VL threshold triggering a switch to second-line ART in future WHO guidelines.",2021,"This pre-planned nested study assesses the prevalence of resistance-associated mutations (RAMs) in SESOTHO trial participants. ","['Lesotho from 2017 to 2020, found that patients with persistent viraemia below this threshold (100-999 copies/mL) benefit from switching to second-line ART', '80 persons taking NNRTI-based first-line ART with low-level HIV-1 viraemia (100-999 copies/mL) and randomized them (1:1) to', 'persons with low-level viraemia while taking NNRTI-based first-line ART enrolled', 'trial participants']",['switch to a PI-based second-line regimen (switch) or continue on first-line therapy (control'],[],"[{'cui': 'C0023376', 'cui_str': 'Lesotho'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C5191069', 'cui_str': '999'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.224736,"This pre-planned nested study assesses the prevalence of resistance-associated mutations (RAMs) in SESOTHO trial participants. ","[{'ForeName': 'Jennifer Anne', 'Initials': 'JA', 'LastName': 'Brown', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Amstutz', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Bienvenu Lengo', 'Initials': 'BL', 'LastName': 'Nsakala', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Seeburg', 'Affiliation': 'Molecular Virology, Department of Biomedicine, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Vanobberghen', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'Vanobberghen', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Muhairwe', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Klimkait', 'Affiliation': 'Molecular Virology, Department of Biomedicine, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Niklaus', 'Initials': 'N', 'LastName': 'Daniel Labhardt', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkab025'] 2204,33598937,Effect of a brief motivational intervention in the immediate postpartum period on breastfeeding self-efficacy: Randomized controlled trial.,"Brief motivational intervention (bMI) is a therapeutic approach that encourages self-efficacy and may have a positive effect on breastfeeding self-efficacy (BSE). The purpose of this study was to analyze the effectiveness of a bMI in increasing BSE in women who started breastfeeding in the immediate postpartum period and to explore the roles of general self-efficacy and other baseline variables in this relationship. A randomized, parallel-group clinical trial was carried out. A bMI was compared with an educational session on breastfeeding. Changes in BSE and its dimensions and the interaction and mediation/moderation of general self-efficacy and other variables were analyzed. BSE increased in the bMI group from a mean baseline score of 59.14 (±9.35) to 64.62 (±7.91) at 1st month (p < 0.001). An interaction was found in that only women with higher education had an improvement in BSE during the follow-up period that was attributable to the bMI (mean difference between the bMI and the attention control group: 18.25 (95% confidence interval: 5.86-30.19; p = 0.006). This interaction was not found for the changes produced in the intrapersonal thoughts dimension of BSE, whose scores were higher in the bMI group at 3 and 6 months. General self-efficacy exerted a moderating effect on the association of bMI with BSE change. The effect of bMI was no longer significant when the general self-efficacy score was above 84. Thus, bMI is effective in increasing BSE. This effectiveness was limited by the mother's educational level and moderated by baseline general self-efficacy.",2021,An interaction was found in that only women with higher education had an improvement in BSE during the follow-up period that was attributable to the bMI (mean difference between the bMI and the attention control group: 18.25 (95% confidence interval: 5.86-30.19; p = 0.006).,['women who started breastfeeding in the immediate postpartum period'],"['brief motivational intervention', 'Brief motivational intervention (bMI', 'bMI']","['breastfeeding self-efficacy', 'general self-efficacy score', 'BSE']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085105', 'cui_str': 'Breast self-examination'}]",,0.0331615,An interaction was found in that only women with higher education had an improvement in BSE during the follow-up period that was attributable to the bMI (mean difference between the bMI and the attention control group: 18.25 (95% confidence interval: 5.86-30.19; p = 0.006).,"[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Franco-Antonio', 'Affiliation': 'Department of Nursing, Nursing and Occupational Therapy College, University of Extremadura, Cáceres, Spain.'}, {'ForeName': 'Esperanza', 'Initials': 'E', 'LastName': 'Santano-Mogena', 'Affiliation': 'Department of Nursing, Nursing and Occupational Therapy College, University of Extremadura, Cáceres, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Sánchez-García', 'Affiliation': 'Health and Care Research Group (GISyC), University of Extremadura, Cáceres, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Chimento-Díaz', 'Affiliation': 'Health and Care Research Group (GISyC), University of Extremadura, Cáceres, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Cordovilla-Guardia', 'Affiliation': 'Department of Nursing, Nursing and Occupational Therapy College, University of Extremadura, Cáceres, Spain.'}]",Research in nursing & health,['10.1002/nur.22115'] 2205,33588893,"Impact of treating iron deficiency, diagnosed according to hepcidin quantification, on outcomes after a prolonged ICU stay compared to standard care: a multicenter, randomized, single-blinded trial.","BACKGROUND Anemia is a significant problem in patients on ICU. Its commonest cause, iron deficiency (ID), is difficult to diagnose in the context of inflammation. Hepcidin is a new marker of ID. We aimed to assess whether hepcidin levels would accurately guide treatment of ID in critically ill anemic patients after a prolonged ICU stay and affect the post-ICU outcomes. METHODS In a controlled, single-blinded, multicenter study, anemic (WHO definition) critically ill patients with an ICU stay ≥ 5 days were randomized when discharge was expected to either intervention by hepcidin treatment protocol or control. In the intervention arm, patients were treated with intravenous iron (1 g of ferric carboxymaltose) when hepcidin was < 20 μg/l and with intravenous iron and erythropoietin for 20 ≤ hepcidin < 41 μg/l. Control patients were treated according to standard care (hepcidin quantification remained blinded). Primary endpoint was the number of days spent in hospital 90 days after ICU discharge (post-ICU LOS). Secondary endpoints were day 15 anemia, day 30 fatigue, day 90 mortality and 1-year survival. RESULTS Of 405 randomized patients, 399 were analyzed (201 in intervention and 198 in control arm). A total of 220 patients (55%) had ID at discharge (i.e., a hepcidin < 41 μg/l). Primary endpoint was not different (medians (IQR) post-ICU LOS 33(13;90) vs. 33(11;90) days for intervention and control, respectively, median difference - 1(- 3;1) days, p = 0.78). D90 mortality was significantly lower in intervention arm (16(8%) vs 33(16.6%) deaths, absolute risk difference - 8.7 (- 15.1 to - 2.3)%, p = 0.008, OR 95% IC, 0.46, 0.22-0.94, p = 0.035), and one-year survival was improved (p = 0.04). CONCLUSION Treatment of ID diagnosed according to hepcidin levels did not reduce the post-ICU LOS, but was associated with a significant reduction in D90 mortality and with improved 1-year survival in critically ill patients about to be discharged after a prolonged stay. TRIAL REGISTRATION www.clinicaltrial.gov NCT02276690 (October 28, 2014; retrospectively registered).",2021,"D90 mortality was significantly lower in intervention arm (16(8%) vs 33(16.6%) deaths, absolute risk difference - 8.7 (- 15.1 to - 2.3)%, p = 0.008, OR 95% IC, 0.46, 0.22-0.94, p = 0.035), and one-year survival was improved (p = 0.04). ","['patients on ICU', 'critically ill anemic patients after a prolonged ICU stay and affect the post-ICU outcomes', 'anemic (WHO definition) critically ill patients with an ICU stay\u2009≥\u20095\xa0days', '220 patients (55%) had ID at discharge (i.e., a hepcidin', '405 randomized patients']","['Hepcidin', 'intravenous iron (1\xa0g of ferric carboxymaltose', 'hepcidin treatment protocol or control', 'hepcidin was\u2009<\u200920\xa0μg/l and with intravenous iron and erythropoietin for 20\u2009≤\u2009hepcidin\u2009<\u200941\xa0μg/l']","['year survival', 'number of days spent in hospital 90\xa0days after ICU discharge (post-ICU LOS', 'day 15 anemia, day 30 fatigue, day 90 mortality and 1-year survival', 'D90 mortality', '1-year survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C4517768', 'cui_str': '405'}]","[{'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C2001867', 'cui_str': 'ferric carboxymaltose'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",405.0,0.286186,"D90 mortality was significantly lower in intervention arm (16(8%) vs 33(16.6%) deaths, absolute risk difference - 8.7 (- 15.1 to - 2.3)%, p = 0.008, OR 95% IC, 0.46, 0.22-0.94, p = 0.035), and one-year survival was improved (p = 0.04). ","[{'ForeName': 'Sigismond', 'Initials': 'S', 'LastName': 'Lasocki', 'Affiliation': ""Département Anesthésie Réanimation, CHU Angers, Université D'Angers, 4 rue Larrey, 49933, Angers Cedex 9, France. sigismond@lasocki.com.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Asfar', 'Affiliation': ""Département Médecine Intensive Réanimation, CHU Angers, Université D'Angers, Angers, France.""}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Jaber', 'Affiliation': 'Département Anesthésie Réanimation, Université de Montpellier, Montpellier, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Ferrandiere', 'Affiliation': 'Département Anesthésie Réanimation, CHU de Tours, Université de Tours, Tours, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kerforne', 'Affiliation': ""Service D'anesthésie-réanimation, CHU de Poitiers, Université de Poitiers, Poitiers, France.""}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Asehnoune', 'Affiliation': 'Département Anesthésie Réanimation, CHU de Nantes, Université de Nantes, Nantes, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Montravers', 'Affiliation': 'Département Anesthésie Réanimation, APHP, HUPNSV, CHU Bichat, Université Paris Diderot Sorbonne, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Seguin', 'Affiliation': 'Département Anesthésie Réanimation, CHU de Rennes, Université de Rennes, Rennes, France.'}, {'ForeName': 'Katell', 'Initials': 'K', 'LastName': ""Peoc'h"", 'Affiliation': ""INSERM U1149, UFR de Médecine Bichat, Centre de Recherche Sur L'Inflammation, Université de Paris, Paris, France.""}, {'ForeName': 'Soizic', 'Initials': 'S', 'LastName': 'Gergaud', 'Affiliation': ""Département Anesthésie Réanimation, CHU Angers, Université D'Angers, 4 rue Larrey, 49933, Angers Cedex 9, France.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Nagot', 'Affiliation': ""Département D'information médicale, CHU Montpellier, Université de Montpellier, Montpellier, France.""}, {'ForeName': 'Thibaud', 'Initials': 'T', 'LastName': 'Lefebvre', 'Affiliation': ""INSERM U1149, UFR de Médecine Bichat, Centre de Recherche Sur L'Inflammation, Université de Paris, Paris, France.""}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Lehmann', 'Affiliation': 'Laboratoire de Biochimie Protéomique Clinique Et IRMB INSERM, CHU de Montpellier, Université de Montpellier, Montpellier, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Critical care (London, England)",['10.1186/s13054-020-03430-3'] 2206,33588293,Effect of Smartphone Laparoscopy Simulator on Laparoscopic Performance in Medical Students.,"BACKGROUND This study aims to investigate if a smartphone laparoscopy simulator, SimuSurg, is effective in improving laparoscopic skills in surgically inexperienced medical students. METHODS This is a single-blinded randomized controlled trial featuring 30 preclinical medical students without prior laparoscopic simulation experience. The students were randomly allocated to a control or intervention group (n = 15 each) and 28 students completed the study (n = 14 each). All participants performed three validated exercises in a laparoscopic box trainer and repeated them after 1 week. The intervention group spent the intervening time completing all levels in SimuSurg, whereas the control group refrained from any laparoscopic activity. A prestudy questionnaire was used to collect data on age, sex, handedness, and experience with gaming. RESULTS The total score improved significantly between the two testing sessions for the intervention group (n = 14, median change [MC] = 182.00, P = 0.009) but not for the control group (n = 14, MC = 161.50, P = 0.08). Scores for the nondominant hand improved significantly in the intervention group (MC = 66.50, P = 0.008) but not in the control group (MC = 9.00, P = 0.98). There was no improvement in dominant hand scores for either the intervention (MC = 62.00, P = 0.08) or control (MC = 26.00, P = 0.32) groups. Interest in surgery (β = -234.30, P = 0.02) was positively correlated with the baseline total scores; however, age, sex, and experience with video games were not. CONCLUSIONS The results suggest that smartphone applications improve laparoscopic skills in medical students, especially for the nondominant hand. These simulators may be a cost-effective and accessible adjunct for laparoscopic training among surgically inexperienced students and clinicians.",2021,These simulators may be a cost-effective and accessible adjunct for laparoscopic training among surgically inexperienced students and clinicians.,"['group (n\xa0=\xa015 each) and 28 students completed the study (n\xa0=\xa014 each', '30 preclinical medical students without prior laparoscopic simulation experience', 'medical students', 'Medical Students', 'surgically inexperienced medical students']","['Smartphone Laparoscopy Simulator', 'smartphone laparoscopy simulator', 'smartphone', 'control or intervention']","['total score', 'laparoscopic skills', 'Laparoscopic Performance']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}]",30.0,0.0325935,These simulators may be a cost-effective and accessible adjunct for laparoscopic training among surgically inexperienced students and clinicians.,"[{'ForeName': 'Wasim', 'Initials': 'W', 'LastName': 'Awal', 'Affiliation': 'Gold Coast University Hospital, Southport, Queensland, Australia. Electronic address: wasim.awal123@gmail.com.'}, {'ForeName': 'Lakal', 'Initials': 'L', 'LastName': 'Dissabandara', 'Affiliation': 'School of Medicine, Griffith University, Southport, Queensland, Australia.'}, {'ForeName': 'Zain', 'Initials': 'Z', 'LastName': 'Khan', 'Affiliation': 'School of Medicine, Griffith University, Southport, Queensland, Australia.'}, {'ForeName': 'Arunan', 'Initials': 'A', 'LastName': 'Jeyakumar', 'Affiliation': 'School of Medicine, Griffith University, Southport, Queensland, Australia.'}, {'ForeName': 'Malak', 'Initials': 'M', 'LastName': 'Habib', 'Affiliation': 'School of Medicine, Griffith University, Southport, Queensland, Australia.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Byfield', 'Affiliation': 'School of Medicine, Griffith University, Southport, Queensland, Australia.'}]",The Journal of surgical research,['10.1016/j.jss.2021.01.003'] 2207,33820449,The acute impact of resistance training on fatigue in patients with pulmonary sarcoidosis.,"Fatigue is the most prevalent symptom among patients with sarcoidosis, and skeletal muscle dysfunction is a common clinical feature, making resistance training (RT) a recommended treatment strategy. Despite lacking knowledge regarding whether high-intensity RT will aggravate fatigue, low to moderate-intensity is routinely used even if the evidence for this protocol to improve muscle strength is inconclusive. This study aimed to investigate whether one single session of high-intensity RT induces a higher increase in fatigue than one single session of moderate-intensity RT. In this randomized crossover study, 41 patients with pulmonary sarcoidosis (age: 53 ± 11 yr) were recruited. They randomly performed one single session of high-intensity RT, 4 sets × 5 repetitions maximum (5RM), and one single session of moderate-intensity RT, 2 sets × 25 RM. Fatigue was assessed with the Visual Analogue Scale (0-100 mm) immediately before (T0), immediately after (T1) and 24 hours after (T2) each exercise session. Fatigue development from T0 to T1 was significantly lower after 5RM (-3 ± 18 mm) than after 25RM (5 ± 15 mm), p = 0.004. No difference was seen from T0 to T2 between 5RM (0 ± 17 mm) and 25RM (6 ± 18 mm), p = 0.147. The high-intensity 5RM session did not induce a larger increase in fatigue than the moderate-intensity 25RM session. RT appears feasible and safe in patients with pulmonary sarcoidosis irrespective of the intensity. Thus, the long-term effects of high-intensity RT on fatigue should be explored in a RT programme of longer duration.",2020,Fatigue development from T0 to T1 was significantly lower after 5RM,"['patients with pulmonary sarcoidosis irrespective of the intensity', '41 patients with pulmonary sarcoidosis (age: 53 ± 11 yr', 'patients with pulmonary sarcoidosis']","['RT', '5RM', 'resistance training']","['Fatigue development', 'Fatigue', 'Visual Analogue Scale', 'fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036205', 'cui_str': 'Pulmonary sarcoidosis'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",41.0,0.0293776,Fatigue development from T0 to T1 was significantly lower after 5RM,"[{'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Grongstad', 'Affiliation': 'LHL Hospital Gardermoen, Jessheim, Norway.'}, {'ForeName': 'Nina Køpke', 'Initials': 'NK', 'LastName': 'Vøllestad', 'Affiliation': 'Department of Interdisciplinary Health Sciences, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Line Merethe', 'Initials': 'LM', 'LastName': 'Oldervoll', 'Affiliation': 'LHL Clinics, Trondheim, Norway.'}, {'ForeName': 'Martijn Arthur', 'Initials': 'MA', 'LastName': 'Spruit', 'Affiliation': 'Department of Research & Development, CIRO, Horn, The Netherlands.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Edvardsen', 'Affiliation': 'LHL Hospital Gardermoen, Jessheim, Norway.'}]",Chronic respiratory disease,['10.1177/1479973120967024'] 2208,33599706,Association of Bone Metastatic Burden With Survival Benefit From Prostate Radiotherapy in Patients With Newly Diagnosed Metastatic Prostate Cancer: A Secondary Analysis of a Randomized Clinical Trial.,"Importance Prostate radiotherapy (RT) improves survival in men with low-burden metastatic prostate cancer. However, owing to the dichotomized nature of metastatic burden criteria, it is not clear how this benefit varies with bone metastasis counts and metastatic site. Objective To evaluate the association of bone metastasis count and location with survival benefit from prostate RT. Design, Setting, and Participants This exploratory analysis of treatment outcomes based on metastatic site and extent as determined by conventional imaging (computed tomography/magnetic resonance imaging and bone scan) evaluated patients with newly diagnosed metastatic prostate cancer randomized within the STAMPEDE trial's metastasis M1 RT comparison. The association of baseline bone metastasis counts with overall survival (OS) and failure-free survival (FFS) was assessed using a multivariable fractional polynomial interaction procedure. Further analysis was conducted in subgroups. Interventions Patients were randomized to receive either standard of care (androgen deprivation therapy with or without docetaxel) or standard of care and prostate RT. Main Outcomes and Measures The primary outcomes were OS and FFS. Results A total of 1939 of 2061 men were included (median [interquartile range] age, 68 [63-73] years); 1732 (89%) had bone metastases. Bone metastasis counts were associated with OS and FFS benefit from prostate RT. Survival benefit decreased continuously as the number of bone metastases increased, with benefit most pronounced up to 3 bone metastases. A plot of estimated treatment effect indicated that the upper 95% CI crossed the line of equivalence (hazard ratio [HR], 1) above 3 bone metastases without a detectable change point. Further analysis based on subgroups showed that the magnitude of benefit from the addition of prostate RT was greater in patients with low metastatic burden with only nonregional lymph nodes (M1a) or 3 or fewer bone metastases without visceral metastasis (HR for OS, 0.62; 95% CI, 0.46-0.83; HR for FFS, 0.57; 95% CI, 0.47-0.70) than among patients with 4 or more bone metastases or any visceral/other metastasis (HR for OS, 1.08; 95% CI, 0.91-1.28; interaction P = .003; HR for FFS, 0.87; 95% CI, 0.76-0.99; interaction P = .002). Conclusions and Relevance In this exploratory analysis of a randomized clinical trial, bone metastasis count and metastasis location based on conventional imaging were associated with OS and FFS benefit from prostate RT in M1 disease. Trial Registration ClinicalTrials.gov Identifier: NCT00268476; ISRCTN.com Identifier: ISRCTN78818544.",2021,The association of baseline bone metastasis counts with overall survival (OS) and failure-free survival (FFS) was assessed using a multivariable fractional polynomial interaction procedure.,"['Patients', 'Newly Diagnosed Metastatic Prostate Cancer', ""patients with newly diagnosed metastatic prostate cancer randomized within the STAMPEDE trial's metastasis M1 RT comparison"", 'men with low-burden metastatic prostate cancer', 'A total of 1939 of 2061 men were included (median [interquartile range] age, 68 [63-73] years); 1732 (89%) had bone metastases']","['conventional imaging (computed tomography/magnetic resonance imaging and bone scan', 'standard of care (androgen deprivation therapy with or without docetaxel) or standard of care and prostate RT', 'Importance\n\n\nProstate radiotherapy (RT', 'Prostate Radiotherapy']","['survival', 'baseline bone metastasis counts with overall survival (OS) and failure-free survival (FFS', 'OS and FFS', 'Survival benefit', 'number of bone metastases', 'Bone metastasis counts', 'Bone Metastatic Burden']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0936223', 'cui_str': 'Prostate cancer metastatic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0153690', 'cui_str': 'Secondary malignant neoplasm of bone'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0203668', 'cui_str': 'Radioisotope scan of bone'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0948317', 'cui_str': 'Radiotherapy to prostate'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0153690', 'cui_str': 'Secondary malignant neoplasm of bone'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}]",2061.0,0.354377,The association of baseline bone metastasis counts with overall survival (OS) and failure-free survival (FFS) was assessed using a multivariable fractional polynomial interaction procedure.,"[{'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': 'Genito-Urinary Cancer Research Group, Division of Cancer Sciences, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Hoyle', 'Affiliation': 'Genito-Urinary Cancer Research Group, Division of Cancer Sciences, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Áine M', 'Initials': 'ÁM', 'LastName': 'Haran', 'Affiliation': 'Genito-Urinary Cancer Research Group, Division of Cancer Sciences, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Brawley', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, United Kingdom.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Cook', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, United Kingdom.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Amos', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, United Kingdom.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Calvert', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, United Kingdom.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Douis', 'Affiliation': 'Department of Radiology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom.'}, {'ForeName': 'Malcolm D', 'Initials': 'MD', 'LastName': 'Mason', 'Affiliation': 'Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dearnaley', 'Affiliation': 'Royal Marsden Hospital and The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Gerhardt', 'Initials': 'G', 'LastName': 'Attard', 'Affiliation': 'UCL Cancer Institute, London, United Kingdom.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Gillessen', 'Affiliation': 'Division of Cancer Sciences, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Mahesh K B', 'Initials': 'MKB', 'LastName': 'Parmar', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, United Kingdom.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Parker', 'Affiliation': 'Royal Marsden Hospital and The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Sydes', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, United Kingdom.'}, {'ForeName': 'Nicholas D', 'Initials': 'ND', 'LastName': 'James', 'Affiliation': 'Royal Marsden Hospital and The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Noel W', 'Initials': 'NW', 'LastName': 'Clarke', 'Affiliation': 'Genito-Urinary Cancer Research Group, Division of Cancer Sciences, The University of Manchester, Manchester, United Kingdom.'}]",JAMA oncology,['10.1001/jamaoncol.2020.7857'] 2209,33599688,Association of Immunophenotype With Pathologic Complete Response to Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer: A Secondary Analysis of the BrighTNess Phase 3 Randomized Clinical Trial.,"Importance Adding carboplatin to standard neoadjuvant chemotherapy (NAC) in triple-negative breast cancer (TNBC) likely benefits a subset of patients; however, determinants of benefit are poorly understood. Objective To define the association of molecular subtype, tumor proliferation, and immunophenotype with benefit of carboplatin added to NAC for patients with stages II to III TNBC. Design, Setting, and Participants This was a prespecified secondary analysis of a phase 3, double-blind, randomized clinical trial (BrighTNess) that enrolled 634 women across 145 centers in 15 countries. Women with clinical stages II to III TNBC who had undergone pretreatment biopsy were eligible to participate. Whole transcriptome RNA sequencing was performed on the biopsy specimens. The prespecified end point was association of pathologic complete response (pCR) with gene expression-based molecular subtype, with secondary end points investigating established signatures (proliferation, immune) and exploratory analyses of immunophenotype. Data were collected from April 2014 to March 2016. The study analyses were performed from January 2018 to March 2019. Interventions Neoadjuvant chemotherapy with paclitaxel followed by doxorubicin and cyclophosphamide, or this same regimen with carboplatin or carboplatin plus veliparib. Main Outcomes and Measures Association of gene expression-based molecular subtype (PAM50 and TNBC subtypes) with pCR. Results Of the 634 women (median age, 51 [range, 22-78] years) enrolled in BrighTNess, 482 (76%) patients had evaluable RNA sequencing data, with similar baseline characteristics relative to the overall intention-to-treat population. Pathologic complete response was significantly more frequent in PAM50 basal-like vs nonbasal-like cancers overall (202 of 386 [52.3%] vs 34 of 96 [35.4%]; P = .003). Carboplatin benefit was not significantly different in basal-like vs nonbasal-like subgroups (P = .80 for interaction). In multivariable analysis, proliferation (hazard ratio, 0.36; 95% CI, 0.21-0.61; P < .001) and immune (hazard ratio, 0.62; 95% CI, 0.49-0.79; P < .001) signatures were independently associated with pCR. Tumors above the median for proliferation and immune signatures had the highest pCR rate (84 of 125; 67%), while those below the median for both signatures had the lowest pCR rate (42 of 125; 34%). Exploratory gene expression immune analyses suggested that tumors with higher inferred CD8+ T-cell infiltration may receive greater benefit with addition of carboplatin. Conclusions and Relevance In this secondary analysis of a randomized clinical trial, triple-negative breast cancer subtyping revealed high pCR rates in basal-like and immunomodulatory subsets. Analysis of biological processes related to basal-like and immunomodulatory phenotypes identified tumor cell proliferation and immune scores as independent factors associated with achieving pCR; the benefit of carboplatin on pCR was seen across all molecular subtypes. Further validation of immunophenotype with existing biomarkers may help to escalate or de-escalate therapy for patients with TNBC. Trial Registration ClinicalTrials.gov Identifier: NCT02032277.",2021,"Tumors above the median for proliferation and immune signatures had the highest pCR rate (84 of 125; 67%), while those below the median for both signatures had the lowest pCR rate (42 of 125; 34%).","['enrolled 634 women across 145 centers in 15 countries', 'patients with stages II to III TNBC', '634 women (median age, 51 [range, 22-78] years) enrolled in BrighTNess, 482 (76', 'patients with TNBC', 'Women with clinical stages II to III TNBC who had undergone pretreatment biopsy were eligible to participate', 'Triple-Negative Breast Cancer']","['carboplatin added to NAC', 'carboplatin', 'carboplatin to standard neoadjuvant chemotherapy (NAC', 'carboplatin or carboplatin plus veliparib', 'Immunophenotype', 'Neoadjuvant Chemotherapy', 'paclitaxel followed by doxorubicin and cyclophosphamide']","['highest pCR rate', 'Measures\n\n\nAssociation of gene expression-based molecular subtype (PAM50 and TNBC subtypes) with pCR', 'pathologic complete response (pCR) with gene expression-based molecular subtype, with secondary end points investigating established signatures (proliferation, immune) and exploratory analyses of immunophenotype', 'Carboplatin benefit', 'lowest pCR rate', 'pCR rates', 'Pathologic complete response']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205571', 'cui_str': 'Clinical stage II'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]","[{'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1958300', 'cui_str': 'veliparib'}, {'cui': 'C0079611', 'cui_str': 'Immunophenotyping'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0334094', 'cui_str': 'Proliferation'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0079611', 'cui_str': 'Immunophenotyping'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",634.0,0.281871,"Tumors above the median for proliferation and immune signatures had the highest pCR rate (84 of 125; 67%), while those below the median for both signatures had the lowest pCR rate (42 of 125; 34%).","[{'ForeName': 'Otto Metzger', 'Initials': 'OM', 'LastName': 'Filho', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Daniel G', 'Initials': 'DG', 'LastName': 'Stover', 'Affiliation': 'Department of Medicine, The Ohio State University College of Medicine, Columbus.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Asad', 'Affiliation': 'Division of Medical Oncology, The Ohio State University Comprehensive Cancer Center, Columbus.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Ansell', 'Affiliation': 'AbbVie, Inc, North Chicago, Illinois.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Watson', 'Affiliation': 'Washington University, St Louis, Missouri.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Geyer', 'Affiliation': 'Massey Cancer Center, Virginia Commonwealth University, Richmond.'}, {'ForeName': 'Junu', 'Initials': 'J', 'LastName': 'Bae', 'Affiliation': 'Department of Medicine, The Ohio State University College of Medicine, Columbus.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Collier', 'Affiliation': 'Department of Medicine, The Ohio State University College of Medicine, Columbus.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Cherian', 'Affiliation': 'Department of Medicine, The Ohio State University College of Medicine, Columbus.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': ""O'Shaughnessy"", 'Affiliation': 'Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Untch', 'Affiliation': 'Helios Klinikum Berlin-Buch, Berlin, Germany.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Jens B', 'Initials': 'JB', 'LastName': 'Huober', 'Affiliation': 'University Medical Center Ulm, Ulm, Germany.'}, {'ForeName': 'Mehra', 'Initials': 'M', 'LastName': 'Golshan', 'Affiliation': ""Division of Breast Surgery, Department of Surgery, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Sikov', 'Affiliation': 'Women and Infants Hospital of Rhode Island, Providence.'}, {'ForeName': 'Gunter', 'Initials': 'G', 'LastName': 'von Minckwitz', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Rastogi', 'Affiliation': 'University of Pittsburgh Medical Center, Hillman Cancer Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Maag', 'Affiliation': 'AbbVie, Inc, North Chicago, Illinois.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Wolmark', 'Affiliation': 'Allegheny General Hospital, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Denkert', 'Affiliation': 'Institute of Physiology and Pathophysiology, Department of Medicine, Philipps-University Marburg and University Hospital of Giessen and Marburg, Marburg, Germany.'}, {'ForeName': 'W Fraser', 'Initials': 'WF', 'LastName': 'Symmans', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston.'}]",JAMA oncology,['10.1001/jamaoncol.2020.7310'] 2210,33598759,Methylphenidate decreases the EEG mu power in the right primary motor cortex in healthy adults during motor imagery and execution.,"This study investigated the effects of dopaminergic drugs on the EEG mu power during motor imagery, action observation, and execution. This is a double-blind, crossover study with a sample of 15 healthy adults under placebo vs. methylphenidate vs. risperidone conditions during motor imagery, action observation, and execution tasks. The participants had drug dosage adjustment based on body weight/dose (mg/kg). We also analyzed the mu band power by electroencephalography during the study steps. The main result is the interaction between the condition and task factors for the C3 and C4 electrodes, with decreasing EEG mu power in the methylphenidate when compared to risperidone (p ≤ 0.0083). Our results can indicate that the methylphenidate decreases the neurophysiological activity in the central cortical regions during the perceptual experience of tasks with or without body movement.",2021,"The main result is the interaction between the condition and task factors for the C3 and C4 electrodes, with decreasing EEG mu power in the methylphenidate when compared to risperidone (p ≤ 0.0083).","['participants had drug dosage adjustment based on body weight/dose (mg/kg', '15 healthy adults under', 'healthy adults']","['placebo vs. methylphenidate vs. risperidone', 'methylphenidate', 'Methylphenidate', 'risperidone']","['neurophysiological activity', 'EEG mu power']","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]",15.0,0.0322511,"The main result is the interaction between the condition and task factors for the C3 and C4 electrodes, with decreasing EEG mu power in the methylphenidate when compared to risperidone (p ≤ 0.0083).","[{'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Aprigio', 'Affiliation': 'Brain Mapping and Sensory Motor Integration Laboratory, Institute of Psychiatry of Federal, University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Bittencourt', 'Affiliation': 'Neurophysiology and Neuropsychology of Attention Laboratory, Institute of Psychiatry of the Federal University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Gongora', 'Affiliation': 'Brain Mapping and Sensory Motor Integration Laboratory, Institute of Psychiatry of Federal, University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Marinho', 'Affiliation': 'The Northeast Biotechnology Network (RENORBIO), Federal University of Piauí, Teresina, Brazil. victormarinhophb@hotmail.com.'}, {'ForeName': 'Silmar', 'Initials': 'S', 'LastName': 'Teixeira', 'Affiliation': 'The Northeast Biotechnology Network (RENORBIO), Federal University of Piauí, Teresina, Brazil.'}, {'ForeName': 'Victor Hugo', 'Initials': 'VH', 'LastName': 'Bastos', 'Affiliation': 'The Northeast Biotechnology Network (RENORBIO), Federal University of Piauí, Teresina, Brazil.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Cagy', 'Affiliation': 'Brain Mapping and Sensory Motor Integration Laboratory, Institute of Psychiatry of Federal, University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Budde', 'Affiliation': 'Faculty of Human Sciences, Medical School Hamburg, Sport Science, Reykjavik University, Reykjavik, Iceland.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Ribeiro', 'Affiliation': 'Brain Mapping and Sensory Motor Integration Laboratory, Institute of Psychiatry of Federal, University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Luis Fernando', 'Initials': 'LF', 'LastName': 'Basile', 'Affiliation': 'Division of Neurosurgery, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Velasques', 'Affiliation': 'Neurophysiology and Neuropsychology of Attention Laboratory, Institute of Psychiatry of the Federal University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil.'}]",Brain structure & function,['10.1007/s00429-021-02233-8'] 2211,33596863,"Influence of painless one-eye blindness on depression, anxiety and quality of life in glaucoma patients with a normal fellow eye.","BACKGROUND For clinical practice it is important to evaluate and compare anxiety, depression and quality of life of glaucoma patients with painless one-eye blindness and a normal fellow eye to unaffected age-matched individuals from a similar environment. METHODS Twenty-eight stable glaucoma patients (age, mean ± SD: 69.0 ± 13.3 years) with one normal and one painless blind eye, and 26 controls (age: 67.0 ± 14.0 years) completed the standard Hungarian adaptations of the Beck Depression Inventory, Beck Anxiety Inventory, Spielberger-Trait Anxiety Inventory, Hopelessness Scale, and Quality of Life Questionnaire SF-36 with the assistance of trained psychologist interviewers within 3 months after a detailed ophthalmological examination. RESULTS The groups did not differ in age, gender distribution, number of children, grandchildren and people in their household (p ≥ 0.235). The best corrected visual acuity (BCVA) of the diseased eye was minimal (median: 0.00), while BCVA of their better eye (median: 1.0) did not differ from that of the control group (p ≥ 0.694). Compared to the control group, the patients' scores were significantly higher for depression (p ≤ 0.01), cognitive and psychophysiological symptoms of anxiety (p ≤ 0.05) and hopelessness (p ≤ 0.013), and lower (worse) for physical function, vitality, general health and bodily pain (p ≤ 0.045). No difference was found between the groups for mental health, physical role functioning, emotional role functioning and social role functioning (p ≥ 0.117). CONCLUSION Our results show that patients with glaucoma-related one-eye blindness may require regular psychological support even when the visual performance of the fellow eye is fully maintained on the long run, and the patients' everyday functioning is normal.",2021,"No difference was found between the groups for mental health, physical role functioning, emotional role functioning and social role functioning (p ≥ 0.117). ","['Twenty-eight stable glaucoma patients (age, mean\u2009±\u2009SD: 69.0\u2009±\u200913.3\u2009years) with one normal and one painless blind eye, and 26 controls (age: 67.0\u2009±\u200914.0\u2009years', 'patients with glaucoma-related one-eye blindness', 'glaucoma patients with painless one-eye blindness and a normal fellow eye to unaffected age-matched individuals from a similar environment', 'glaucoma patients with a normal fellow eye']",[],"['hopelessness', 'standard Hungarian adaptations of the Beck Depression Inventory, Beck Anxiety Inventory, Spielberger-Trait Anxiety Inventory, Hopelessness Scale, and Quality of Life Questionnaire SF-36', 'corrected visual acuity (BCVA) of the diseased eye', 'cognitive and\xa0psychophysiological symptoms of anxiety', 'depression, anxiety and quality of life', 'anxiety, depression and quality of life', 'mental health, physical role functioning, emotional role functioning and social role functioning', 'physical function, vitality, general health and bodily pain']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0234226', 'cui_str': 'Painless'}, {'cui': 'C0271240', 'cui_str': 'Blindness of one eye'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]",[],"[{'cui': 'C0150041', 'cui_str': 'Feeling hopeless'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0020173', 'cui_str': 'Hungarian language'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0451217', 'cui_str': 'Hopelessness scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",28.0,0.0745123,"No difference was found between the groups for mental health, physical role functioning, emotional role functioning and social role functioning (p ≥ 0.117). ","[{'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Holló', 'Affiliation': 'Department of Ophthalmology, Semmelweis University, Mária u. 39, Budapest, 1085, Hungary. hollo.gabor@med.semmelweis-univ.hu.'}, {'ForeName': 'Nikolett Gabriella', 'Initials': 'NG', 'LastName': 'Sándor', 'Affiliation': 'Department of Personality and Clinical Psychology, Pázmány Péter Catholic University, Institute of Psychology, Budapest, Hungary.'}, {'ForeName': 'Péter', 'Initials': 'P', 'LastName': 'Kóthy', 'Affiliation': 'Department of Ophthalmology, Semmelweis University, Mária u. 39, Budapest, 1085, Hungary.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Géczy', 'Affiliation': 'Department of Personality and Clinical Psychology, Pázmány Péter Catholic University, Institute of Psychology, Budapest, Hungary.'}]",BMC ophthalmology,['10.1186/s12886-021-01845-2'] 2212,33596734,Differences in brain structure and theta burst stimulation-induced plasticity implicate the corticomotor system in loss of function after musculoskeletal injury.,"Traumatic musculoskeletal injury (MSI) may involve changes in corticomotor structure and function, but direct evidence is needed. To determine the corticomotor basis of MSI, we examined interactions among skeletomotor function, corticospinal excitability, corticomotor structure (cortical thickness and white matter microstructure), and intermittent theta burst stimulation (iTBS)-induced plasticity. Nine women with unilateral anterior cruciate ligament rupture (ACL) 3.2 ± 1.1 yr prior to the study and 11 matched controls (CON) completed an MRI session followed by an offline plasticity-probing protocol using a randomized, sham-controlled, double-blind, cross-over study design. iTBS was applied to the injured (ACL) or nondominant (CON) motor cortex leg representation (M1 LEG ) with plasticity assessed based on changes in skeletomotor function and corticospinal excitability compared with sham iTBS. The results showed persistent loss of function in the injured quadriceps, compensatory adaptations in the uninjured quadriceps and both hamstrings, and injury-specific increases in corticospinal excitability. Injury was associated with lateralized reductions in paracentral lobule thickness, greater centrality of nonleg corticomotor regions, and increased primary somatosensory cortex leg area inefficiency and eccentricity. Individual responses to iTBS were consistent with the principles of homeostatic metaplasticity; corresponded to injury-related differences in skeletomotor function, corticospinal excitability, and corticomotor structure; and suggested that corticomotor adaptations involve both hemispheres. Moreover, iTBS normalized skeletomotor function and corticospinal excitability in ACL. The results of this investigation directly confirm corticomotor involvement in chronic loss of function after traumatic MSI, emphasize the sensitivity of the corticomotor system to skeletomotor events and behaviors, and raise the possibility that brain-targeted therapies could improve recovery. NEW & NOTEWORTHY Traumatic musculoskeletal injuries may involve adaptive changes in the brain that contribute to loss of function. Our combination of neuroimaging and theta burst transcranial magnetic stimulation (iTBS) revealed distinct patterns of iTBS-induced plasticity that normalized differences in muscle and brain function evident years after unilateral knee ligament rupture. Individual responses to iTBS corresponded to injury-specific differences in brain structure and physiological activity, depended on skeletomotor deficit severity, and suggested that corticomotor adaptations involve both hemispheres.",2021,"Injury was associated with lateralized reductions in paracentral lobule thickness, greater centrality of non-leg corticomotor regions, and reduced (increased) primary somatosensory cortex leg area efficiency (segregation).","['Traumatic musculoskeletal injury (MSI', 'Nine women with unilateral anterior cruciate ligament rupture']",[],"['paracentral lobule thickness, greater centrality of non-leg corticomotor regions, and reduced (increased) primary somatosensory cortex leg area efficiency (segregation', 'corticospinal excitability', 'skeletomotor function and corticospinal excitability']","[{'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0272448', 'cui_str': 'Injury of musculoskeletal system'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0409312', 'cui_str': 'Rupture of anterior cruciate ligament'}]",[],"[{'cui': 'C0228203', 'cui_str': 'Structure of paracentral lobule'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C3496281', 'cui_str': 'Primary Somatic Sensory Area'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0080141', 'cui_str': 'Racial Segregation'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",9.0,0.0619659,"Injury was associated with lateralized reductions in paracentral lobule thickness, greater centrality of non-leg corticomotor regions, and reduced (increased) primary somatosensory cortex leg area efficiency (segregation).","[{'ForeName': 'Shawn D', 'Initials': 'SD', 'LastName': 'Flanagan', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Proessl', 'Affiliation': 'Neuromuscular Research Laboratory, Department of Sports Medicine and Nutrition, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Courtenay', 'Initials': 'C', 'LastName': 'Dunn-Lewis', 'Affiliation': 'Department of Cardiothoracic Surgery, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Sterczala', 'Affiliation': 'Neuromuscular Research Laboratory, Department of Sports Medicine and Nutrition, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Connaboy', 'Affiliation': 'Neuromuscular Research Laboratory, Department of Sports Medicine and Nutrition, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Canino', 'Affiliation': 'Neuromuscular Research Laboratory, Department of Sports Medicine and Nutrition, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Anne Z', 'Initials': 'AZ', 'LastName': 'Beethe', 'Affiliation': 'Neuromuscular Research Laboratory, Department of Sports Medicine and Nutrition, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Shawn R', 'Initials': 'SR', 'LastName': 'Eagle', 'Affiliation': 'Neuromuscular Research Laboratory, Department of Sports Medicine and Nutrition, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Tunde K', 'Initials': 'TK', 'LastName': 'Szivak', 'Affiliation': 'Department of Health Sciences, Merrimack College, North Andover, Massachusetts.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Onate', 'Affiliation': 'School of Health and Rehabilitation Sciences, College of Medicine, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Volek', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Carl M', 'Initials': 'CM', 'LastName': 'Maresh', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Kaeding', 'Affiliation': 'Sports Health and Performance Institute, Department of Orthopaedics, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Kraemer', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, Ohio.'}]",Journal of neurophysiology,['10.1152/jn.00689.2020'] 2213,33596722,Human corticospinal-motoneuronal output is reduced with 5-HT 2 receptor antagonism.,"Animal models indicate that serotonin (5-HT) release onto motoneurons facilitates motor output, particularly during strong motor activities. However, evidence for 5-HT effects during human movement are limited. This study examined how antagonism of the 5-HT 2 receptor, which is a 5-HT receptor that promotes motoneuron excitability, affects human movement. Ten healthy participants (24.2 ± 1.9 yr) ingested 8 mg of cyproheptadine (competitive 5-HT 2 antagonist) in a double-blinded, placebo-controlled, repeated-measures design. Transcranial magnetic stimulation (TMS) of the motor cortex was used to elicit motor evoked potentials (MEPs) from biceps brachii. First, stimulus-response curves (90%-160% active motor threshold) were obtained during very weak elbow flexions (10% of maximal). Second, to determine if 5-HT effects are scaled to the intensity of muscle contraction, TMS at a fixed intensity was applied during elbow flexions of 20%, 40%, 60%, 80%, and 100% of maximal. Cyproheptadine reduced the size of MEPs across the stimulus-response curves ( P = 0.045). Notably, MEP amplitude was 22.3% smaller for the cyproheptadine condition for the strongest TMS intensity. In addition, cyproheptadine reduced maximal torque ( P = 0.045), lengthened the biceps silent period during maximal elbow flexions ( P = 0.037), and reduced superimposed twitch amplitude during moderate-intensity elbow flexions ( P = 0.035). This study presents novel evidence that 5-HT 2 receptors influence corticospinal-motoneuronal output, which was particularly evident when a large number of descending inputs to motoneurons were active. Although it is likely that antagonism of 5-HT 2 receptors reduces motoneuron gain to ionotropic inputs, supraspinal mechanisms may have also contributed to the study findings. NEW & NOTEWORTHY Voluntary contractions and responses to magnetic stimulation of the motor cortex are dependent on serotonin activity in the central nervous system. 5-HT 2 antagonism decreased evoked potential size to high-intensity stimulation, and reduced torque and lengthened inhibitory silent periods during maximal contractions. We provide novel evidence that 5-HT 2 receptors are involved in muscle activation, where 5-HT effects are strongest when a large number of descending inputs activate motoneurons.",2021,Cyproheptadine reduced the size of MEPs across the stimulus-response curves (P = 0.045).,['Ten healthy participants (24.2 ± 1.9 yr) ingested 8 mg of'],"['cyproheptadine', 'Cyproheptadine', 'Transcranial magnetic stimulation (TMS', 'cyproheptadine (competitive 5-HT2 antagonist', 'serotonin (5-HT']","['maximal torque', 'superimposed twitch amplitude', 'MEP amplitude', 'size of MEPs']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4517517', 'cui_str': '1.9'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0010620', 'cui_str': 'Cyproheptadine'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C2936522', 'cui_str': '5-HT2 Antagonist'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0054871', 'cui_str': 'Cathepsin L'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}]",10.0,0.112937,Cyproheptadine reduced the size of MEPs across the stimulus-response curves (P = 0.045).,"[{'ForeName': 'Jacob R', 'Initials': 'JR', 'LastName': 'Thorstensen', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Janet L', 'Initials': 'JL', 'LastName': 'Taylor', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Perth, Western Australia, Australia.'}, {'ForeName': 'Justin J', 'Initials': 'JJ', 'LastName': 'Kavanagh', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia.'}]",Journal of neurophysiology,['10.1152/jn.00698.2020'] 2214,33595663,Evaluation of Optimal Diastolic Blood Pressure Range Among Adults With Treated Systolic Blood Pressure Less Than 130 mm Hg.,"Importance Extremely low diastolic blood pressure has been reported to be associated with increased adverse cardiovascular events (ie, the diastolic J-shape phenomenon); however, current US guidelines recommend an intensive blood pressure target of less than 130/80 mm Hg without mentioning the lower limits of diastolic blood pressure. Objectives To evaluate whether there is a diastolic J-shape phenomenon for patients with an treated systolic blood pressure of less than 130 mm Hg and to explore the safe and optimal diastolic blood pressure ranges for this patient population. Design, Setting, and Participants This cohort study analyzed outcome data of patients at high cardiovascular risk who were randomized to intensive or standard blood pressure control and achieved treated systolic blood pressure of less than 130 mm Hg in the Systolic Blood Pressure Intervention Trial (SPRINT) and Action to Control Cardiovascular Risk in Diabetes-Blood Pressure (ACCORD-BP) trial. Data were collected from October 2010 to August 2015 (SPRINT) and from September 1999 to June 2009 (ACCORD-BP). Data were analyzed from January to May 2020. Exposure Treated diastolic blood pressure, divided in intervals of less than 60, 60 to less than 70, 70 to less than 80, and 80 mm Hg and greater. Main Outcomes and Measures The primary outcome was a composite of all-cause death, nonfatal myocardial infarction, and nonfatal stroke. A composite cardiovascular outcome, including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, was among the key secondary outcomes. Results A total of 7515 patients (mean [SD] age, 65.6 [8.7] years; 4553 [60.6%] men) were included in this analysis. The nominally lowest risk was observed at a diastolic blood pressure between 70 and 80 mm Hg for the primary outcome, the composite cardiovascular outcome, nonfatal myocardial infarction, and cardiovascular death. A mean diastolic blood pressure of less than 60 mm Hg was associated with significantly increased risk of the primary outcome (hazard ratio [HR], 1.46; 95% CI, 1.13-1.90; P = .004), the composite cardiovascular outcome (HR, 1.74; 95% CI, 1.26-2.41; P = .001), nonfatal myocardial infarction (HR, 1.73; 95% CI, 1.15-2.59; P = .008), and nonfatal stroke (HR, 2.67; 95% CI, 1.26-5.63; P = .01). Conclusions and Relevance This cohort study found that lowering diastolic blood pressure to less than 60 mm Hg was associated with increased risk of cardiovascular events in patients with high cardiovascular risk and an treated systolic blood pressure less than 130 mm Hg. The finding that a diastolic blood pressure value between 70 and 80 mm Hg was an optimum target for this patient population merits further study.",2021,"A composite cardiovascular outcome, including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, was among the key secondary outcomes. ","['patients with high cardiovascular risk and an treated systolic blood pressure less than 130 mm Hg', '7515 patients (mean [SD] age', '65.6 [8.7] years; 4553', 'Exposure\n\n\nTreated diastolic blood pressure, divided in intervals of less than 60, 60 to less than 70, 70 to less than 80, and 80 mm Hg and greater', 'patients at high cardiovascular risk who were randomized to', 'patients with an treated systolic blood pressure of less than 130 mm Hg', 'Adults With Treated Systolic Blood Pressure']",['intensive or standard blood pressure control and achieved treated systolic blood pressure of less than 130 mm Hg in the Systolic Blood Pressure Intervention Trial (SPRINT) and Action to Control Cardiovascular Risk'],"['composite of all-cause death, nonfatal myocardial infarction, and nonfatal stroke', 'composite cardiovascular outcome, nonfatal myocardial infarction, and cardiovascular death', 'risk of cardiovascular events', 'mean diastolic blood pressure', 'nonfatal myocardial infarction', 'composite cardiovascular outcome', 'diastolic blood pressure value', 'diastolic blood pressure', 'cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke', 'nonfatal stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",7515.0,0.19176,"A composite cardiovascular outcome, including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, was among the key secondary outcomes. ","[{'ForeName': 'Jingen', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Virend K', 'Initials': 'VK', 'LastName': 'Somers', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Internal Medicine Division, Tieying Hospital of Fengtai District, Beijing, China.'}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Cardiovascular Diseases Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, National Clinical Research Center for Chinese Medicine Cardiology, Beijing, China.'}, {'ForeName': 'Jianqing', 'Initials': 'J', 'LastName': 'Ju', 'Affiliation': 'Cardiovascular Diseases Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, National Clinical Research Center for Chinese Medicine Cardiology, Beijing, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Lin', 'Affiliation': 'Cardiovascular Diseases Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, National Clinical Research Center for Chinese Medicine Cardiology, Beijing, China.'}, {'ForeName': 'Essa A', 'Initials': 'EA', 'LastName': 'Mohamed', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Shahid', 'Initials': 'S', 'LastName': 'Karim', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Cardiovascular Diseases Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, National Clinical Research Center for Chinese Medicine Cardiology, Beijing, China.'}, {'ForeName': 'Lijing', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.37554'] 2215,33592561,"First-line Chemotherapy in Advanced Biliary Tract Cancer Ten Years After the ABC-02 Trial: ""And Yet It Moves!""","Biliary tract cancers (BTCs) include a heterogeneous group of highly aggressive hepatobiliary malignancies, representing the 3% of all gastrointestinal cancers and the second most frequent type of primary liver cancer after hepatocellular carcinoma. Ten years after the publication of the phase III, randomized, ABC-02 trial, the combination of cisplatin plus gemcitabine remains the standard first-line treatment for patients with advanced BTC. In the last decade, a large number of attempts has been made to improve the efficacy of the reference doublet by using novel drugs or adding a third agent to cisplatin-gemcitabine. Unfortunately, despite the addition of different cytotoxic drugs failed to improve clinical outcomes in several studies, recently published clinical trials have provided interesting results, and other first-line chemotherapy options are currently under investigation in randomized phase III studies. Moreover, recent years have witnessed the parallel emergence of molecularly targeted therapies and immune checkpoint inhibitors, with these novel agents having the potential to revolutionize the therapeutic algorithm of advanced BTC. In this review, we will provide an overview on first-line therapeutic opportunities currently available in the management of advanced BTCs, especially focusing on recently published data and ongoing clinical trials in this setting.",2021,"Ten years after the publication of the phase III, randomized, ABC-02 trial, the combination of cisplatin plus gemcitabine remains the standard first-line treatment for patients with advanced BTC.","['patients with advanced BTC', 'Ten Years', 'Advanced Biliary Tract Cancer']","['cisplatin plus gemcitabine', 'cisplatin-gemcitabine', 'First-line Chemotherapy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0053251', 'cui_str': 'Benzotrichloride'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750952', 'cui_str': 'Malignant tumor of biliary tract'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.0327104,"Ten years after the publication of the phase III, randomized, ABC-02 trial, the combination of cisplatin plus gemcitabine remains the standard first-line treatment for patients with advanced BTC.","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Rizzo', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, S. Orsola-Malpighi University Hospital, Bologna, Italy; Oncologia Medica, Azienda Ospedaliero-Universitaria di Bologna, via Albertoni, 15 Bologna, Italy. Electronic address: rizzo.alessandro179@gmail.com.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Brandi', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, S. Orsola-Malpighi University Hospital, Bologna, Italy; Oncologia Medica, Azienda Ospedaliero-Universitaria di Bologna, via Albertoni, 15 Bologna, Italy.'}]",Cancer treatment and research communications,['10.1016/j.ctarc.2021.100335'] 2216,33592558,Effect of Δ9-Tetrahydrocannabinol on frontostriatal resting state functional connectivity and subjective euphoric response in healthy young adults.,"BACKGROUND Few studies have examined how Δ9-Tetrahydrocannabinol (THC), the main psychoactive component of cannabis, impacts brain reward circuitry in humans. In this study, we examined if an acute dose of THC altered resting state functional connectivity between the striatum and prefrontal cortex among healthy young adults with limited cannabis use. METHODS Participants received THC (n = 24) or placebo (n = 22) in a double-blind, randomized, between-subject design. Participants completed self-report measures of euphoria and drug-liking throughout the visit. Approximately 120 min after drug administration, participants completed an 8-min resting state functional MRI (rs-fMRI) scan. We utilized seed-based connectivity of the striatum (bilateral putamen, caudate, and NAcc seeds) to the frontal cortex. RESULTS Individuals who received THC demonstrated greater rs-fMRI connectivity between the right NAcc and regions of the medial prefrontal cortex (mPFC) (p-values<0.05, corrected) and higher subjective euphoria ratings (p = .03) compared to compared to individuals who received placebo. Higher ratings of euphoria were related to greater right NAcc-dorsal mPFC (dmPFC) connectivity for the THC group (p=.03), but not for the placebo group (p=.98). CONCLUSIONS This is one of the first studies to examine rs-fMRI connectivity in healthy young non-users after THC administration. We found individuals receiving THC show greater rs-fMRI connectivity between the NAcc and mPFC, regions implicated in reward, compared to individuals receiving placebo. In addition, individuals receiving THC reported higher subjective euphoria ratings, which were positively associated with NAcc-dmPFC connectivity. Overall, our findings suggest THC may produce subjective and neural reward responses that contribute to the rewarding, reinforcing properties of cannabis.",2021,"RESULTS Individuals who received THC demonstrated greater rs-fMRI connectivity between the right NAcc and regions of the medial prefrontal cortex (mPFC) (p-values<0.05, corrected) and higher subjective euphoria ratings (p = .03) compared to compared to individuals who received placebo.","['healthy young non-users after THC administration', 'healthy young adults', 'Participants received THC (n\u2009=\u200924) or', 'healthy young adults with limited cannabis use']","['Δ9-Tetrahydrocannabinol (THC', 'placebo', 'Δ9-Tetrahydrocannabinol', 'THC']","['right NAcc-dorsal mPFC (dmPFC) connectivity', 'medial prefrontal cortex (mPFC', 'rs-fMRI connectivity', 'euphoria and drug-liking', 'subjective euphoria ratings', 'Higher ratings of euphoria']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0235146', 'cui_str': 'Euphoria'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.239823,"RESULTS Individuals who received THC demonstrated greater rs-fMRI connectivity between the right NAcc and regions of the medial prefrontal cortex (mPFC) (p-values<0.05, corrected) and higher subjective euphoria ratings (p = .03) compared to compared to individuals who received placebo.","[{'ForeName': 'Natania A', 'Initials': 'NA', 'LastName': 'Crane', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, United States. Electronic address: ncrane3@uic.edu.'}, {'ForeName': 'K Luan', 'Initials': 'KL', 'LastName': 'Phan', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, United States; Department of Psychiatry and Behavioral Health, The Ohio State University, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.108565'] 2217,33592551,Effects of art-based mandala intervention on distress and anxiety in cancer patients.,"OBJECTIVE This study was planned to determine the effect of art-based mandala intervention on the distress and anxiety experienced by cancer patients. METHODS This semi-experimental study with a single group pretest-posttest design was performed with 12 breast cancer survival patients. The data were collected through ""Patient Diagnostic Form"", ""Distress Thermometer"", ""Trait Anxiety Inventory"". Patients participated in the ""Art-Based Mandala Interventıon"" for eight weeks, one day a week, 2 h each. The distress and anxiety levels of the patients were measured before starting the program and at the end of the program. RESULTS Cancer patients experienced moderate level of anxiety (50.66 ± 6.91) and clinically significant distress (4.08 ± 2.74). Anxiety scores of cancer patients decreased significantly after the program compared to before the program (p < 0.05). The distress scores of cancer patients increased after the program compared to before the program (p > 0.05). CONCLUSION After the art-based mandala intervention program, anxiety scores of breast cancer survival patients decreased, and distress scores increased.",2021,Anxiety scores of cancer patients decreased significantly after the program compared to before the program (p < 0.05).,"['cancer patients', 'distress and anxiety experienced by cancer patients', '12 breast cancer survival patients']",['art-based mandala intervention'],"['anxiety scores of breast cancer survival', 'moderate level of anxiety', 'distress and anxiety', 'Anxiety scores of cancer patients', 'distress scores of cancer patients', 'distress and anxiety levels']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",12.0,0.0286735,Anxiety scores of cancer patients decreased significantly after the program compared to before the program (p < 0.05).,"[{'ForeName': 'Hatice Karabuga', 'Initials': 'HK', 'LastName': 'Yakar', 'Affiliation': 'Faculty of Health Sciences, Department of Nursing, Marmara University, Istanbul, Turkey. Electronic address: hatice.karabuga@marmara.edu.tr.'}, {'ForeName': 'Banu', 'Initials': 'B', 'LastName': 'Yilmaz', 'Affiliation': 'Mandala Meditation Therapy Specialist, Bachelor of Arts in Human Behavior, Newport International University, California, United States.'}, {'ForeName': 'Ozan', 'Initials': 'O', 'LastName': 'Ozkol', 'Affiliation': 'License Graduated Nurse, Faculty of Health Sciences, Department of Nursing, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Fadime', 'Initials': 'F', 'LastName': 'Gevher', 'Affiliation': 'License Graduated Nurse, Faculty of Health Sciences, Department of Nursing, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Celik', 'Affiliation': 'License Graduated Nurse, Faculty of Health Sciences, Department of Nursing, Marmara University, Istanbul, Turkey.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101331'] 2218,33602643,Effect of intraoperative secretin on operative outcomes in pancreatic resection: A randomized controlled trial.,"BACKGROUND Objectives: We performed a randomized, double-blind, placebo-controlled trial to determine if using Secretin intra-operatively to identify leaks and subsequently target operative intervention would decrease the frequency of clinically significant post-operative pancreatic fistula formation. METHODS Patients undergoing pancreaticoduodenectomy or distal pancreatectomy were randomized to receive intra-operative Secretin or placebo intra-operatively following the completed pancreaticojejunostomy or closure of the cut remnant stump. If a potential leak was identified, targeted therapy with directed suture placement was performed. RESULTS 170 patients were randomized; 83 receiving placebo and 87 receiving Secretin. The rate of clinically significant fistula formation was 3% (3/87) in the Secretin group and 6% (5/83) in the placebo group (p = 0.489). The rate of biochemical leak was 29% (25/87) in the Secretin group and 19% (16/83) in the placebo group (p = 0.157). There were no Grade C post-operative fistula in either group. Of the 9% of patients in the Secretin group who had a targeted intra-operative intervention, none developed a clinically significant fistula. Adverse events were similar between groups. CONCLUSIONS Compared to placebo, intra-operative Secretin administration was not associated with an overall reduction in clinically significant pancreatic fistula formation. However, patients with an intra-operative leak identified by Secretin may benefit from intervention (clinicaltrials.gov: NCT02160808).",2021,"Compared to placebo, intra-operative Secretin administration was not associated with an overall reduction in clinically significant pancreatic fistula formation.","['Patients undergoing pancreaticoduodenectomy or distal pancreatectomy', '170 patients were randomized; 83 receiving', 'pancreatic resection']","['Secretin', 'intraoperative secretin', 'intra-operative Secretin or placebo intra-operatively following the completed pancreaticojejunostomy or closure of the cut remnant stump', 'placebo']","['rate of biochemical leak', 'operative outcomes', 'Adverse events', 'rate of clinically significant fistula formation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0176940', 'cui_str': 'Distal subtotal pancreatectomy'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0854522', 'cui_str': 'Pancreatic resection'}]","[{'cui': 'C0036534', 'cui_str': 'Secretin'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030303', 'cui_str': 'Pancreaticojejunostomy'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0002690', 'cui_str': 'Amputation stump'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",170.0,0.628549,"Compared to placebo, intra-operative Secretin administration was not associated with an overall reduction in clinically significant pancreatic fistula formation.","[{'ForeName': 'Kerrington D', 'Initials': 'KD', 'LastName': 'Smith', 'Affiliation': 'Section of General Surgery, Dartmouth-Hitchcock Medical Center, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Barth', 'Affiliation': 'Section of General Surgery, Dartmouth-Hitchcock Medical Center, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Colacchio', 'Affiliation': 'Section of General Surgery, Dartmouth-Hitchcock Medical Center, USA.'}, {'ForeName': 'Jessica I', 'Initials': 'JI', 'LastName': 'Chevalier', 'Affiliation': 'Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, USA.'}, {'ForeName': 'Lindsay E', 'Initials': 'LE', 'LastName': 'Bergmann', 'Affiliation': 'Section of General Surgery, Dartmouth-Hitchcock Medical Center, USA.'}, {'ForeName': 'Edward D', 'Initials': 'ED', 'LastName': 'Purich', 'Affiliation': 'ChiRhoClin, Inc, Burtonsville, MD, USA.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Gardner', 'Affiliation': 'Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, USA. Electronic address: timothy.b.gardner@hitchcock.org.'}]",Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.],['10.1016/j.pan.2021.02.002'] 2219,33622669,"The SimpliciT1 Study: A Randomized, Double-Blind, Placebo-Controlled Phase 1b/2 Adaptive Study of TTP399, a Hepatoselective Glucokinase Activator, for Adjunctive Treatment of Type 1 Diabetes.","OBJECTIVE Despite advances in exogenous insulin therapy, many patients with type 1 diabetes do not achieve acceptable glycemic control and remain at risk for ketosis and insulin-induced hypoglycemia. We conducted a randomized controlled trial to determine whether TTP399, a novel hepatoselective glucokinase activator, improved glycemic control in people with type 1 diabetes without increasing hypoglycemia or ketosis. RESEARCH DESIGN AND METHODS SimpliciT1 was a phase 1b/2 adaptive study. Phase 2 activities were conducted in two parts. Part 1 randomly assigned 20 participants using continuous glucose monitors and continuous subcutaneous insulin infusion (CSII). Part 2 randomly assigned 85 participants receiving multiple daily injections of insulin or CSII. In both parts 1 and 2, participants were randomly assigned to 800 mg TTP399 or matched placebo (fully blinded) and treated for 12 weeks. The primary end point was change in HbA 1c from baseline to week 12. RESULTS The difference in change in HbA 1c from baseline to week 12 between TTP399 and placebo was -0.7% (95% CI -1.3, -0.07) in part 1 and -0.21% (95% CI -0.39, -0.04) in part 2. Despite a greater decrease in HbA 1c with TTP399, the frequency of severe or symptomatic hypoglycemia decreased by 40% relative to placebo in part 2. In both parts 1 and 2, plasma β-hydroxybutyrate and urinary ketones were lower during treatment with TTP399 than placebo. CONCLUSIONS TTP399 lowers HbA 1c and reduces hypoglycemia without increasing the risk of ketosis and should be further evaluated as an adjunctive therapy for the treatment of type 1 diabetes.",2021,"In both parts 1 and 2, plasma β-hydroxybutrate and urinary ketones were lower during treatment with TTP399 than placebo. ","['patients with type 1 diabetes', 'Type 1 Diabetes', 'people with type 1 diabetes without increasing hypoglycemia or ketosis']","['multiple daily injections of insulin or CSII', 'TTP399', 'placebo', 'TTP399 or matched placebo', 'continuous glucose monitors and continuous subcutaneous insulin infusion (CSII', 'Placebo']","['plasma β-hydroxybutrate and urinary ketones', 'hypoglycemia', 'frequency of severe or symptomatic hypoglycemia', 'change in HbA 1c']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0022638', 'cui_str': 'Ketosis'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}]",20.0,0.193933,"In both parts 1 and 2, plasma β-hydroxybutrate and urinary ketones were lower during treatment with TTP399 than placebo. ","[{'ForeName': 'Klara R', 'Initials': 'KR', 'LastName': 'Klein', 'Affiliation': 'Division of Endocrinology and Metabolism, University of North Carolina School of Medicine, Chapel Hill, NC klara_klein@med.unc.edu.'}, {'ForeName': 'Jennifer L R', 'Initials': 'JLR', 'LastName': 'Freeman', 'Affiliation': 'vTv Therapeutics LLC, High Point, NC.'}, {'ForeName': 'Imogene', 'Initials': 'I', 'LastName': 'Dunn', 'Affiliation': 'vTv Therapeutics LLC, High Point, NC.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Dvergsten', 'Affiliation': 'vTv Therapeutics LLC, High Point, NC.'}, {'ForeName': 'M Sue', 'Initials': 'MS', 'LastName': 'Kirkman', 'Affiliation': 'Division of Endocrinology and Metabolism, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'Division of Endocrinology and Metabolism, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Valcarce', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc20-2684'] 2220,33622650,Research Note: Estimating the complier average causal effect when participants in randomised trials depart from allocated treatment.,,2021,,[],[],[],[],[],[],,0.0982511,,"[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Kasza', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Australia. Electronic address: jessica.kasza@monash.edu.'}]",Journal of physiotherapy,['10.1016/j.jphys.2021.02.002'] 2221,33622624,Vitamin B12 supplementation orally and intramuscularly in people with obesity undergoing gastric bypass.,"PURPOSE Although bariatric surgery can facilitate weight loss and improve many diseases, it impairs the absorption of many vitamins and micronutrients. Vitamin B12 is important for these patients and should be controlled and supplemented postoperatively. The aim of this paper is to compare serum vitamin B12 levels in two forms of supplementation (oral vs. intramuscular) for 6 months after gastric bypass. METHODS In a prospective controlled cohort study, people with obesity patients undergoing gastric bypass received vitamin B12 supplementation either orally or intramuscularly. The patients were followed for 6 months, receiving serial doses of vitamin B12 and methylmalonic acid assessment at 6 months. RESULTS A total of 53 patients were divided into two homogeneous groups: an oral group (n=24) and an intramuscular group (n=29). Serum vitamin B12 was measured preoperatively and postoperatively at 1, 2, 3, and 6 months. Serum methylmalonic acid was measured at 6 months. At each point, the serum vitamin B12 level remained within reference values in both groups, although it was higher in the oral group (p<0.001). Methylmalonic acid also remained within reference values in both groups, with no significant differences. CONCLUSION Despite the anatomical and functional alterations that impair vitamin B12 absorption after gastric bypass, oral vitamin B12 supplementation was as effective as intramuscular in this population.",2021,"At each point, the serum vitamin B12 level remained within reference values in both groups, although it was higher in the oral group (p<0.001).","['53 patients', 'people with obesity undergoing gastric bypass', 'after gastric bypass', 'people with obesity patients undergoing gastric bypass received']","['vitamin B12 supplementation either orally or intramuscularly', 'vitamin B12 and methylmalonic acid assessment at 6 months', 'oral vitamin B12 supplementation', 'Vitamin B12 supplementation']","['serum vitamin B12 level', 'Serum vitamin B12', 'vitamin B12 absorption', 'Methylmalonic acid', 'serum vitamin B12 levels', 'Serum methylmalonic acid']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}]","[{'cui': 'C4524262', 'cui_str': 'Vitamin B12 supplementation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0025787', 'cui_str': 'Methyl malonic acid'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0427408', 'cui_str': 'Serum vitamin B12 measurement'}, {'cui': 'C0412482', 'cui_str': 'Vitamin B12 absorption'}, {'cui': 'C0025787', 'cui_str': 'Methyl malonic acid'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",53.0,0.0366573,"At each point, the serum vitamin B12 level remained within reference values in both groups, although it was higher in the oral group (p<0.001).","[{'ForeName': 'Rafael Jacques', 'Initials': 'RJ', 'LastName': 'Ramos', 'Affiliation': 'Center for Obesity and Metabolic Syndrome (COM), Hospital São Lucas, Av. Ipiranga, 6690, 90619-900 Porto Alegre, RS, Brazil; Graduate Program in Medicine and Health Sciences, PUCRS, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Cláudio Corá', 'Initials': 'CC', 'LastName': 'Mottin', 'Affiliation': 'Center for Obesity and Metabolic Syndrome (COM), Hospital São Lucas, Av. Ipiranga, 6690, 90619-900 Porto Alegre, RS, Brazil; Graduate Program in Medicine and Health Sciences, PUCRS, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Leticia Biscaino', 'Initials': 'LB', 'LastName': 'Alves', 'Affiliation': 'Center for Obesity and Metabolic Syndrome (COM), Hospital São Lucas, Av. Ipiranga, 6690, 90619-900 Porto Alegre, RS, Brazil; Graduate Program in Medicine and Health Sciences, PUCRS, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Carolina Mattana', 'Initials': 'CM', 'LastName': 'Mulazzani', 'Affiliation': 'PUCRS, School of Medicine, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Alexandre Vontobel', 'Initials': 'AV', 'LastName': 'Padoin', 'Affiliation': 'Center for Obesity and Metabolic Syndrome (COM), Hospital São Lucas, Av. Ipiranga, 6690, 90619-900 Porto Alegre, RS, Brazil; Graduate Program in Medicine and Health Sciences, PUCRS, Porto Alegre, RS, Brazil. Electronic address: alexandre.padoin@pucrs.br.'}]",Obesity research & clinical practice,['10.1016/j.orcp.2021.02.002'] 2222,33819845,A novel reflective practice intervention improves quality of care in the emergency department.,"INTRODUCTION Most interventions to improve clinical outcomes in the emergency department (ED) are based on structural changes. This study embraced a different strategy and examined the impact of a reflective practice intervention (RPI) on ED quality of care. METHODS A pre-post-intervention quasi-experimental nested design was conducted between January 2017 and June 2018 in an Israeli public tertiary academic ED. Nighty-six ED teams (triage and staff nurses and a physician) were included pre and post RPI. Data were collected pre and post RPI at patient-triage nurse encounters using triage-accuracy questionnaires. Time to decision, length-of-stay, and hospitalization and mortality rates were retrieved from the medical charts of 1920 patients (20 per team). RESULTS Accurate triage was significantly higher post than pre intervention (4.84 ± 1.45 vs. 3.87 ± 1.48; range 1-7; p < .001), whereas time to decision (253.30 ± 246.75 vs. 304.64 ± 249.14 min), hospitalization rates (n = 291, 30.3% vs. n = 374, 39.0%; p < .001), and hospital length-of-stay (5.73 ± 6.72 vs. 6.69 ± 6.20; p = .04) significantly decreased. CONCLUSIONS By adapting organizational reflective practice principles to the ED dynamic environment, the RPI was associated with a significant improvement in ED quality-of-care measures.",2021,"RESULTS Accurate triage was significantly higher post than pre intervention (4.84 ± 1.45 vs. 3.87 ± 1.48;",['A pre-post-intervention quasi-experimental nested design was conducted between January 2017 and June 2018 in an Israeli public tertiary academic ED'],['reflective practice intervention (RPI'],"['quality of care', 'hospitalization rates', 'hospital length-of-stay', 'time to decision', 'Time to decision, length-of-stay, and hospitalization and mortality rates', 'ED quality of care']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]",,0.0537297,"RESULTS Accurate triage was significantly higher post than pre intervention (4.84 ± 1.45 vs. 3.87 ± 1.48;","[{'ForeName': 'Mor', 'Initials': 'M', 'LastName': 'Saban', 'Affiliation': 'The Gertner Institute for Epidemiology and Health Policy Research, Ramat Gan, Israel. Electronic address: morsab1608@gmail.com.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Drach-Zahavy', 'Affiliation': 'The Cheryl Spencer Department of Nursing, The Faculty of Social Welfare and Health Sciences, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Efrat', 'Initials': 'E', 'LastName': 'Dagan', 'Affiliation': 'The Cheryl Spencer Department of Nursing, The Faculty of Social Welfare and Health Sciences, University of Haifa, Haifa, Israel.'}]",International emergency nursing,['10.1016/j.ienj.2021.100977'] 2223,33595631,Five-Year Survival Outcomes of Hybrid Minimally Invasive Esophagectomy in Esophageal Cancer: Results of the MIRO Randomized Clinical Trial.,"Importance Available data comparing the long-term results of hybrid minimally invasive esophagectomy (HMIE) with that of open esophagectomy are conflicting, with similar or even better results reported for the minimally invasive esophagectomy group. Objective To evaluate the long-term, 5-year outcomes of HMIE vs open esophagectomy, including overall survival (OS), disease-free survival (DFS), and pattern of disease recurrence, and the potential risk factors associated with these outcomes. Design, Setting, and Participants This randomized clinical trial is a post hoc follow-up study that analyzes the results of the open-label Multicentre Randomized Controlled Phase III Trial, which enrolled patients from 13 different centers in France and was conducted from October 26, 2009, to April 4, 2012. Eligible patients were 18 to 75 years of age and were diagnosed with resectable cancer of the middle or lower third of the esophagus. After exclusions, patients were randomized to either the HMIE group or the open esophagectomy group. Data analysis was performed on an intention-to-treat basis from November 19, 2019, to December 4, 2020. Interventions Hybrid minimally invasive esophagectomy (laparoscopic gastric mobilization with open right thoracotomy) was compared with open esophagectomy. Main Outcomes and Measures The primary end points of this follow-up study were 5-year OS and DFS. The secondary end points were the site of disease recurrence and potential risk factors associated with DFS and OS. Results A total of 207 patients were randomized, of whom 175 were men (85%), and the median (range) age was 61 (23-78) years. The median follow-up duration was 58.2 (95% CI, 56.5-63.8) months. The 5-year OS was 59% (95% CI, 48%-68%) in the HMIE group and 47% (95% CI, 37%-57%) in the open esophagectomy group (hazard ratio [HR], 0.71; 95% CI, 0.48-1.06). The 5-year DFS was 52% (95% CI, 42%-61%) in the HMIE group vs 44% (95% CI, 34%-53%) in the open esophagectomy group (HR, 0.81; 95% CI, 0.55-1.17). No statistically significant difference in recurrence rate or location was found between groups. In a multivariable analysis, major intraoperative and postoperative complications (HR, 2.21; 95% CI, 1.41-3.45; P < .001) and major pulmonary complications (HR, 1.94; 95% CI, 1.21-3.10; P = .005) were identified as risk factors associated with decreased OS. Similarly, multivariable analysis of DFS identified overall intraoperative and postoperative complications (HR, 1.93; 95% CI, 1.28-2.90; P = .002) and major pulmonary complications (HR, 1.85; 95% CI, 1.19-2.86; P = .006) as risk factors. Conclusions and Relevance This study found no difference in long-term survival between the HMIE and open esophagectomy groups. Major postoperative overall complications and pulmonary complications appeared to be independent risk factors in decreased OS and DFS, providing additional evidence that HMIE may be associated with improved oncological results compared with open esophagectomy primarily because of a reduction in postoperative complications. Trial Registration ClinicalTrials.gov Identifier: NCT00937456.",2021,"The 5-year OS was 59% (95% CI, 48%-68%) in the HMIE group and 47% (95% CI, 37%-57%) in the open esophagectomy group (hazard ratio [HR], 0.71; 95% CI, 0.48-1.06).","['Esophageal Cancer', '207 patients were randomized, of whom 175 were men (85%), and the median (range) age was 61 (23-78) years', 'Eligible patients were 18 to 75 years of age and were diagnosed with resectable cancer of the middle or lower third of the esophagus', 'enrolled patients from 13 different centers in France and was conducted from October 26, 2009, to April 4, 2012']","['open esophagectomy group', 'Interventions\n\n\nHybrid minimally invasive esophagectomy (laparoscopic gastric mobilization with open right thoracotomy', 'Hybrid', 'HMIE', 'HMIE vs open esophagectomy', 'Minimally Invasive Esophagectomy', 'hybrid minimally invasive esophagectomy (HMIE']","['major intraoperative and postoperative complications', 'median follow-up duration', 'recurrence rate or location', 'major pulmonary complications', '5-year DFS', 'overall survival (OS), disease-free survival (DFS), and pattern of disease recurrence', '5-year OS and DFS', 'DFS identified overall intraoperative and postoperative complications', '5-year OS', 'site of disease recurrence and potential risk factors associated with DFS and OS', 'long-term survival']","[{'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0227191', 'cui_str': 'Structure of lower third of esophagus'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0039991', 'cui_str': 'Chest wall incision'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0449782', 'cui_str': 'Pattern of disease'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",207.0,0.272836,"The 5-year OS was 59% (95% CI, 48%-68%) in the HMIE group and 47% (95% CI, 37%-57%) in the open esophagectomy group (hazard ratio [HR], 0.71; 95% CI, 0.48-1.06).","[{'ForeName': 'Frederiek', 'Initials': 'F', 'LastName': 'Nuytens', 'Affiliation': 'Department of Digestive and Oncological Surgery, Hôpital Claude Huriez, Centre Hospitalier Universitaire (CHU) de Lille, Lille, France.'}, {'ForeName': 'Tienhan Sandrine', 'Initials': 'TS', 'LastName': 'Dabakuyo-Yonli', 'Affiliation': 'Epidemiology and Quality of Life Unit, Institut National de la Santé et de la Recherche Médicale (INSERM) Unité 1231, Centre Georges François Leclerc, Dijon, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Meunier', 'Affiliation': 'Department of Hepatobiliary and Digestive Surgery, CHU Rennes, University of Rennes 1, Rennes, France.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Gagnière', 'Affiliation': 'Université Clermont Auvergne, INSERM, CHU Clermont-Ferrand, Service de Chirurgie Digestive, Clermont-Ferrand, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Collet', 'Affiliation': 'Department of Digestive Surgery, Haut Lévèque University Hospital, Bordeaux, France.'}, {'ForeName': 'Xavier B', 'Initials': 'XB', 'LastName': ""D'Journo"", 'Affiliation': 'Department of Thoracic Surgery, Hôpital Nord, Aix-Marseille Université, Assistance Publique-Hôpitaux de Marseille, Marseille, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Brigand', 'Affiliation': 'Department of Digestive Surgery, Strasbourg University, Strasbourg, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Perniceni', 'Affiliation': 'Department of Digestive Surgery, Institut Mutualiste Montsouris, Paris, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Carrère', 'Affiliation': 'Department of Digestive Surgery, Purpan Hospital, CHU Toulouse, Université Toulouse III, Toulouse, France.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Mabrut', 'Affiliation': 'Department of General Surgery and Liver Transplantation, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Equipe Mixte de Recherche 3738, Université Lyon 1, Lyon, France.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Msika', 'Affiliation': ""Department of Digestive and General Surgery, CHU Louis Mourier, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris 7, Denis Diderot, Pôle de Recherche et d'Enseignement Supérieur (PRES) Sorbonne Paris Cité, Colombes, France.""}, {'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Peschaud', 'Affiliation': 'Department of Surgery and Oncology, CHU Ambroise Paré, AP-HP, Université de Versailles, Boulogne-Billancourt, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Prudhomme', 'Affiliation': 'Department of Digestive Surgery, CHU Nîmes, Nîmes, France.'}, {'ForeName': 'Sheraz R', 'Initials': 'SR', 'LastName': 'Markar', 'Affiliation': 'Department of Surgery and Cancer, Imperial College, London, United Kingdom.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Piessen', 'Affiliation': 'Department of Digestive and Oncological Surgery, Hôpital Claude Huriez, Centre Hospitalier Universitaire (CHU) de Lille, Lille, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA surgery,['10.1001/jamasurg.2020.7081'] 2224,33595625,Evaluating Growth Patterns of Abdominal Aortic Aneurysm Diameter With Serial Computed Tomography Surveillance.,"Importance Small abdominal aortic aneurysms (AAAs) are common in the elderly population. Their growth rates and patterns, which drive clinical surveillance, are widely disputed. Objective To assess the growth patterns and rates of AAAs as documented on serial computed tomography (CT) scans. Design, Setting, and Participants Cohort study and secondary analysis of the Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial (N-TA3CT), a randomized, double-blind placebo-controlled clinical trial conducted from 2013 to 2018, with CT imaging every 6 months for 2 years. The trial was a multicenter, observational secondary analysis, not related to treatment hypotheses of data collected in the N-TA3CT. Participants included 254 patients with baseline AAA diameter between 3.5 and 5.0 cm. Exposures Patients received serial CT scan measurements, analyzed for maximum transverse diameter, at 6-month intervals. Main Outcomes and Measures The primary study outcome was AAA annual growth rate. Secondary analyses included characterizing AAA growth patterns, assessing likelihood of AAA diameter to exceed sex-specific intervention thresholds over 2 years. Results A total of 254 patients, 35 women with baseline AAA diameter 3.5 to 4.5 cm and 219 men with baseline diameter 3.5 to 5.0 cm, were included. Yearly growth rates of AAA diameters were a median of 0.17 cm/y (interquartile range [IQR], 0.16) and a mean (SD), 0.19 (0.14) cm/y. Ten percent of AAAs displayed minimal to no growth (<0.05 cm/y), 62% displayed low growth (0.05-0.25 cm/y), and 28% displayed high growth (>0.25 cm/y). Baseline AAA diameter accounted for 5.4% of variance of growth rate (P < .001; R2, 0.054). Most AAAs displayed linear growth (70%); large variations in interval growth rates occurred infrequently (3% staccato growth and 4% exponential growth); and some patients' growth patterns were not clearly classifiable (23% indeterminate). No patients with a maximum transverse diameter less than 4.25 cm exceeded sex-specific repair thresholds at 2 years (men, 0 of 92; 95% CI, 0.00-0.055; women, 0 of 25 ; 95% CI, 0.00-0.247). Twenty-six percent of patients with a maximum transverse diameter of at least 4.25 cm exceeded sex-specific repair thresholds at 2 years (n = 12 of 83 men with diameter ranging from 4.25 to <4.75 cm; 95% CI, 0.091-0.264; n = 21 of 44 men with diameter ranging from 4.75-5.0 cm; 95% CI, 0.362-0.669; n = 3 of 10 women with diameter ≥4.25 cm; 95% CI, 0.093-0.726). Conclusions and Relevance Most small AAAs showed linear growth; large intrapatient variations in interval growth rates were infrequently observed over 2 years. Linear growth modeling of AAAs in individual patients suggests smaller AAAs (<4.25 cm) can be followed up with a CT scan in at least 2 years with little chance of exceeding interventional thresholds. Trial Registration ClinicalTrials.gov Identifier: NCT01756833.",2021,"Baseline AAA diameter accounted for 5.4% of variance of growth rate (P < .001; R2, 0.054).","['254 patients, 35 women with baseline AAA diameter 3.5 to 4.5 cm and 219 men with baseline diameter 3.5 to 5.0 cm, were included', 'Participants\n\n\nCohort study and secondary analysis of the Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial', 'Participants included 254 patients with baseline AAA diameter between 3.5 and 5.0 cm', '2013 to 2018, with CT imaging every 6 months for 2 years']","['serial CT scan measurements', 'placebo']","['growth rate', 'interval growth rates', 'AAA annual growth rate', 'Yearly growth rates of AAA diameters', 'growth patterns and rates of AAAs', 'sex-specific repair thresholds', 'linear growth', 'Evaluating Growth Patterns of Abdominal Aortic Aneurysm Diameter', 'characterizing AAA growth patterns, assessing likelihood of AAA diameter to exceed sex-specific intervention thresholds over 2 years']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0003486', 'cui_str': 'Aortic aneurysm'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0162871', 'cui_str': 'Abdominal aortic aneurysm'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0585339', 'cui_str': 'Every six months'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449249', 'cui_str': 'Growth rate'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0003486', 'cui_str': 'Aortic aneurysm'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C1156245', 'cui_str': 'Growth pattern'}, {'cui': 'C0162871', 'cui_str': 'Abdominal aortic aneurysm'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439234', 'cui_str': 'year'}]",254.0,0.252771,"Baseline AAA diameter accounted for 5.4% of variance of growth rate (P < .001; R2, 0.054).","[{'ForeName': 'Sydney L', 'Initials': 'SL', 'LastName': 'Olson', 'Affiliation': 'Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison.'}, {'ForeName': 'Marniker A', 'Initials': 'MA', 'LastName': 'Wijesinha', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Annalise M', 'Initials': 'AM', 'LastName': 'Panthofer', 'Affiliation': 'Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Blackwelder', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Gilbert R', 'Initials': 'GR', 'LastName': 'Upchurch', 'Affiliation': 'Department of Surgery, University of Florida, Gainesville.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Terrin', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Curci', 'Affiliation': 'Division of Vascular Surgery, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'B Timothy', 'Initials': 'BT', 'LastName': 'Baxter', 'Affiliation': 'Division of Vascular Surgery, University of Nebraska School of Medicine, Omaha.'}, {'ForeName': 'Jon S', 'Initials': 'JS', 'LastName': 'Matsumura', 'Affiliation': 'Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison.'}]",JAMA surgery,['10.1001/jamasurg.2020.7190'] 2225,33594720,The effect of pedometer-supported walking and telemonitoring after disc hernia surgery on pain and disability levels and quality of life.,"AIM The aim of this study was to determine the effect of pedometer-supported walking and telemonitoring after lumbar disc hernia surgery on pain and disability levels and quality of life. METHODS This was a randomized controlled trial with two randomly selected groups conducted between March 2018 and January 2019. Sixty-seven participants (33 in the intervention group and 34 in the control group) who had undergone lumbar microdiscectomy were allocated to receive and not to receive walking exercise. Pain and disability levels and quality of life of groups were tested with the McGill Pain Questionnaire, the Oswestry Disability Index and the 36-Item Short Form Survey. Measurements were taken 3 weeks after surgery and following completion of the first, second and third months. RESULTS Compared with the control group, pain level at the first and second months and disability level at the second and third months in the intervention group were significantly lower (p < 0.05), and in the third month, subdimension scores of quality of life (the physical role difficulty, energy and vitality, mental health, social functionality and pain) were higher (p < 0.05). CONCLUSIONS Walking after herniated disc surgery decreased pain and disability levels and increased the quality of life; nurses can encourage adherence to walking as an effective intervention.",2021,"Pain and disability levels and quality of life of groups were tested with the McGill Pain Questionnaire, the Oswestry Disability Index and the 36-Item Short Form Survey.","['Sixty-seven participants (33 in the intervention group and 34 in the control group) who had undergone lumbar microdiscectomy', 'two randomly selected groups conducted between March 2018 and January 2019']","['pedometer-supported walking and telemonitoring after lumbar disc hernia surgery', 'walking exercise', 'pedometer-supported walking and telemonitoring after disc hernia surgery']","['pain level', 'Pain and disability levels and quality of life', 'disability level', 'pain and disability levels', 'subdimension scores of quality of life (the physical role difficulty, energy and vitality, mental health, social functionality and pain', 'pain and disability levels and quality of life', 'McGill Pain Questionnaire, the Oswestry Disability Index']","[{'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0457629', 'cui_str': 'Lumbar microdiscectomy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}]",2.0,0.0711626,"Pain and disability levels and quality of life of groups were tested with the McGill Pain Questionnaire, the Oswestry Disability Index and the 36-Item Short Form Survey.","[{'ForeName': 'Kadriye', 'Initials': 'K', 'LastName': 'Aldemir', 'Affiliation': 'School of Susehri Health High, Sivas Cumhuriyet University, Sivas, Turkey.'}, {'ForeName': 'Aysel', 'Initials': 'A', 'LastName': 'Gürkan', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Marmara University, Istanbul, Turkey.'}]",International journal of nursing practice,['10.1111/ijn.12917'] 2226,33593654,"Re: Maria S. Lindgren, Peter Bue, Nessn Azawi, et al. The DaBlaCa-13 Study: Short-term, Intensive Chemoresection Versus Standard Adjuvant Intravesical Instillations in Non-muscle-invasive Bladder Cancer-A Randomized Controlled Trial. Eur Urol 2020;78:856-62.",,2021,,['Non-muscle-invasive Bladder Cancer'],['Intensive Chemoresection Versus Standard Adjuvant Intravesical Instillations'],[],"[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0021917', 'cui_str': 'Instillation of bladder'}]",[],,0.0411163,,"[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Signorini', 'Affiliation': 'Urology Department, ASST Ovest Milanese, Fornaroli Hospital, Magenta, Italy. Electronic address: clasign@tiscali.it.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Maffezzini', 'Affiliation': 'Urology Department, ASST Ovest Milanese, Fornaroli Hospital, Magenta, Italy.'}]",European urology,['10.1016/j.eururo.2021.01.034'] 2227,33593653,"Reply to Claudia Signorini and Massimo Maffezzini's Letter to the Editor re: Maria S. Lindgren, Peter Bue, Nessn Azawi, et al. The DaBlaCa-13 Study: Short-term, Intensive Chemoresection Versus Standard Adjuvant Intravesical Instillations in Non-muscle-invasive Bladder Cancer-A Randomized Controlled Trial. Eur Urol 2020;78:856-62.",,2021,,['Non-muscle-invasive Bladder Cancer'],['Intensive Chemoresection Versus Standard Adjuvant Intravesical Instillations'],[],"[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0021917', 'cui_str': 'Instillation of bladder'}]",[],,0.0319543,,"[{'ForeName': 'Maria S', 'Initials': 'MS', 'LastName': 'Lindgren', 'Affiliation': 'Department of Urology, Aarhus University Hospital, Aarhus, Denmark; Department of Urology, Gødstrup Hospital, Denmark; Department of Clinical Medicine, Aarhus University, Aarhus Denmark. Electronic address: maalin@rm.dk.'}, {'ForeName': 'Jørgen B', 'Initials': 'JB', 'LastName': 'Jensen', 'Affiliation': 'Department of Urology, Aarhus University Hospital, Aarhus, Denmark; Department of Urology, Gødstrup Hospital, Denmark; Department of Clinical Medicine, Aarhus University, Aarhus Denmark.'}]",European urology,['10.1016/j.eururo.2021.02.001'] 2228,33606269,Certolizumab Pegol for the Treatment of Moderate to Severe Plaque Psoriasis: 16-Week Results from a Phase 2/3 Japanese Study.,"INTRODUCTION Certolizumab pegol (CZP), the Fc-free, PEGylated anti-tumor necrosis factor, is approved for the treatment of moderate to severe plaque psoriasis (PSO) in Western countries and in Japan, among other indications. METHODS We report results from the first 16 weeks of a 52-week phase 2/3 trial of CZP in Japanese patients with PSO. Patients ≥ 20 years with PSO ≥ 6 months (Psoriasis Area and Severity Index [PASI] ≥ 12, body surface area affected ≥ 10%, and Physician's Global Assessment [PGA] ≥ 3 on a 5-point scale) were randomized 2:2:1 to CZP 400 mg every 2 weeks (Q2W), CZP 200 mg Q2W (400 mg weeks 0/2/4), or placebo Q2W. Outcomes assessed to week 16: PASI 75, PASI 90, PGA 0/1 (Markov chain Monte Carlo), Dermatology Life Quality Index (DLQI 0/1) and Itch Numeric Rating Scale (INRS 0) (non-responder imputation), and DLQI and INRS change from baseline (last observation carried forward). Safety data were reported for patients receiving ≥ 1 dose of study medication through weeks 0-16; adverse events were evaluated using Medical Dictionary for Regulatory Activities version 18.1. RESULTS A total of 127 patients were randomized to CZP 400 mg Q2W (N = 53), CZP 200 mg Q2W (N = 48), placebo (N = 26). Week 16 responder rates for CZP 400 mg/200 mg Q2W versus placebo were 87.1%/73.0% versus 7.9% for PASI 75; 75.7%/53.8% versus 0.2% for PASI 90; 66.7%/52.7% versus 0.0% for PGA 0/1 (all p < 0.0001 for both CZP doses versus placebo). Significant improvements in DLQI and INRS were reported at week 16 by patients receiving both CZP doses compared with placebo (p < 0.0001). Incidence of treatment-emergent adverse events within the CZP 400 mg Q2W, CZP 200 mg Q2W, and placebo groups were 326.1, 404.9, and 682.4 per 100 patient-years. No new safety signals were identified compared to previously reported data. CONCLUSION CZP dosed at 400 mg or 200 mg Q2W was associated with improved PSO signs and symptoms. TRIAL REGISTRATION ClinicalTrials.gov identifier, NCT03051217.",2021,Significant improvements in DLQI and INRS were reported at week 16 by patients receiving both CZP doses compared with placebo (p < 0.0001).,"['Japanese patients with PSO', 'Patients\u2009≥', 'Moderate to Severe Plaque Psoriasis', '127 patients', '20\xa0years with PSO\u2009≥']","['Certolizumab Pegol', 'placebo', 'CZP 200\xa0mg Q2W', 'CZP 400\xa0mg Q2W', 'CZP', 'Certolizumab pegol (CZP', 'CZP 400\xa0mg Q2W, CZP 200\xa0mg Q2W, and placebo']","['PSO signs and symptoms', 'DLQI and INRS', 'PASI\xa075, PASI\xa090, PGA\xa00/1 (Markov chain Monte Carlo), Dermatology Life Quality Index (DLQI 0/1) and Itch Numeric Rating Scale (INRS 0) (non-responder imputation), and DLQI and INRS', ""6\xa0months (Psoriasis Area and Severity Index [PASI]\u2009≥\u200912, body surface area affected\u2009≥\u200910%, and Physician's Global Assessment [PGA]\u2009≥\u20093 on a 5-point scale""]","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1872109', 'cui_str': 'certolizumab pegol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4026841', 'cui_str': 'certolizumab pegol 200 MG'}, {'cui': 'C3816746', 'cui_str': '400'}]","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0024828', 'cui_str': 'Markov Chain'}, {'cui': 'C0026507', 'cui_str': 'Monte Carlo Method'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",127.0,0.285011,Significant improvements in DLQI and INRS were reported at week 16 by patients receiving both CZP doses compared with placebo (p < 0.0001).,"[{'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Umezawa', 'Affiliation': 'The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Sakurai', 'Affiliation': 'UCB Japan Co., Ltd., Tokyo, Japan. Shinya.Sakurai@ucb.com.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Hoshii', 'Affiliation': 'UCB Japan Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Hidemi', 'Initials': 'H', 'LastName': 'Nakagawa', 'Affiliation': 'The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Dermatology and therapy,['10.1007/s13555-021-00494-z'] 2229,33605887,A Web-Based eHealth Intervention to Improve the Quality of Life of Older Adults With Multiple Chronic Conditions: Protocol for a Randomized Controlled Trial.,"BACKGROUND Multiple chronic conditions (MCCs) are common among older adults and expensive to manage. Two-thirds of Medicare beneficiaries have multiple conditions (eg, diabetes and osteoarthritis) and account for more than 90% of Medicare spending. Patients with MCCs also experience lower quality of life and worse medical and psychiatric outcomes than patients without MCCs. In primary care settings, where MCCs are generally treated, care often focuses on laboratory results and medication management, and not quality of life, due in part to time constraints. eHealth systems, which have been shown to improve multiple outcomes, may be able to fill the gap, supplementing primary care and improving these patients' lives. OBJECTIVE This study aims to assess the effects of ElderTree (ET), an eHealth intervention for older adults with MCCs, on quality of life and related measures. METHODS In this unblinded study, 346 adults aged 65 years and older with at least 3 of 5 targeted high-risk chronic conditions (hypertension, hyperlipidemia, diabetes, osteoarthritis, and BMI ≥30 kg/m2) were recruited from primary care clinics and randomized in a ratio of 1:1 to one of 2 conditions: usual care (UC) plus laptop computer, internet service, and ET or a control consisting of UC plus laptop and internet but no ET. Patients with ET have access for 12 months and will be followed up for an additional 6 months, for a total of 18 months. The primary outcomes of this study are the differences between the 2 groups with regard to measures of quality of life, psychological well-being, and loneliness. The secondary outcomes are between-group differences in laboratory scores, falls, symptom distress, medication adherence, and crisis and long-term health care use. We will also examine the mediators and moderators of the effects of ET. At baseline and months 6, 12, and 18, patients complete written surveys comprising validated scales selected for good psychometric properties with similar populations; laboratory data are collected from eHealth records; health care use and chronic conditions are collected from health records and patient surveys; and ET use data are collected continuously in system logs. We will use general linear models and linear mixed models to evaluate primary and secondary outcomes over time, with treatment condition as a between-subjects factor. Separate analyses will be conducted for outcomes that are noncontinuous or not correlated with other outcomes. RESULTS Recruitment was conducted from January 2018 to December 2019, and 346 participants were recruited. The intervention period will end in June 2021. CONCLUSIONS With self-management and motivational strategies, health tracking, educational tools, and peer community and support, ET may help improve outcomes for patients coping with ongoing, complex MCCs. In addition, it may relieve some stress on the primary care system, with potential cost implications. TRIAL REGISTRATION ClinicalTrials.gov NCT03387735; https://www.clinicaltrials.gov/ct2/show/NCT03387735. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/25175.",2021,"At baseline and months 6, 12, and 18, patients complete written surveys comprising validated scales selected for good psychometric properties with similar populations; laboratory data are collected from eHealth records; health care use and chronic conditions are collected from health records and patient surveys; and ET use data are collected continuously in system logs.","['346 adults aged 65 years and older with at least 3 of 5 targeted high-risk chronic conditions (hypertension, hyperlipidemia, diabetes, osteoarthritis, and BMI ≥30 kg/m2) were recruited from primary care clinics and randomized in a ratio of 1:1 to one of 2 conditions', 'older adults with MCCs', 'Older Adults With Multiple Chronic Conditions', 'patients coping with ongoing, complex MCCs', 'Recruitment was conducted from January 2018 to December 2019, and 346 participants were recruited']","['usual care (UC) plus laptop computer, internet service, and ET or a control consisting of UC plus laptop and internet but no ET', 'A Web-Based eHealth Intervention', 'eHealth intervention', 'ElderTree (ET']","['quality of life, psychological well-being, and loneliness', 'Quality of Life', 'quality of life and worse medical and psychiatric outcomes', 'laboratory scores, falls, symptom distress, medication adherence, and crisis and long-term health care use']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3266262', 'cui_str': 'Multiple chronic diseases'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1737642', 'cui_str': 'Laptop computer'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",346.0,0.0771652,"At baseline and months 6, 12, and 18, patients complete written surveys comprising validated scales selected for good psychometric properties with similar populations; laboratory data are collected from eHealth records; health care use and chronic conditions are collected from health records and patient surveys; and ET use data are collected continuously in system logs.","[{'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Gustafson', 'Affiliation': 'Center for Health Enhancement Systems Studies, University of Wisconsin-Madison, Madison, WI, United States.'}, {'ForeName': 'Marie-Louise', 'Initials': 'ML', 'LastName': 'Mares', 'Affiliation': 'Department of Communication Arts, University of Wisconsin-Madison, Madison, WI, United States.'}, {'ForeName': 'Darcie C', 'Initials': 'DC', 'LastName': 'Johnston', 'Affiliation': 'Center for Health Enhancement Systems Studies, University of Wisconsin-Madison, Madison, WI, United States.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Mahoney', 'Affiliation': 'Department of Medicine, University of Wisconsin-Madison, Madison, WI, United States.'}, {'ForeName': 'Randall T', 'Initials': 'RT', 'LastName': 'Brown', 'Affiliation': 'Department of Family Medicine, University of Wisconsin School of Medicine & Public Health, Madison, WI, United States.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Landucci', 'Affiliation': 'Center for Health Enhancement Systems Studies, University of Wisconsin-Madison, Madison, WI, United States.'}, {'ForeName': 'Klaren', 'Initials': 'K', 'LastName': 'Pe-Romashko', 'Affiliation': 'Center for Health Enhancement Systems Studies, University of Wisconsin-Madison, Madison, WI, United States.'}, {'ForeName': 'Olivia J', 'Initials': 'OJ', 'LastName': 'Cody', 'Affiliation': 'Center for Health Enhancement Systems Studies, University of Wisconsin-Madison, Madison, WI, United States.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Gustafson', 'Affiliation': 'Center for Health Enhancement Systems Studies, University of Wisconsin-Madison, Madison, WI, United States.'}, {'ForeName': 'Dhavan V', 'Initials': 'DV', 'LastName': 'Shah', 'Affiliation': 'School of Journalism and Mass Communication, University of Wisconsin-Madison, Madison, WI, United States.'}]",JMIR research protocols,['10.2196/25175'] 2230,33608233,Determinants of attrition in a pediatric healthy lifestyle intervention: The CIRCUIT program experience.,"INTRODUCTION Attrition in pediatric weight management programs is notoriously high. Greater understanding of its determinants is needed to inform retention strategies. We identified determinants of attrition in CIRCUIT, a healthy lifestyle intervention program for youth at risk of cardiovascular disease. METHODS A one-arm intervention study of children aged 4-18 years who initiated the CIRCUIT program in the first five years of its existence (N = 403). We defined attrition as attending the baseline visit but ceasing attendance prior to the 1-year follow-up. Potential determinants of dropout included the child's age, sex, ethnicity, body mass index (BMI) z-score, family socio-demographic characteristics, and estimated driving time to the program, all measured at baseline. Associations were estimated bivariately, using chi-squared- and t-tests, and simultaneously in a multivariable logistic regression model. RESULTS Of the 403 participants who started the program, 198 (49%) dropped out within 12 months of enrollment. Youth who dropped out were older (mean age 12.8y vs. 11.3y; p < 0.01), were less likely to live with both parents (62% vs. 71%; p = 0.05), and to have mothers who had completed high school (79% vs. 88%; p = 0.01). No group differences were observed for sex, ethnicity, baseline BMI z-score, fathers' education, or driving time to the program. In multivariate models, only older age at initiation of the intervention (OR: 1.2; CI: 1.1,1.3) and lower maternal education (OR: 2.0; CI: 1.0,3.8) were associated with dropout. CONCLUSION Improved tailoring of interventions to older pediatric participants and to families of lower maternal education may help reduce attrition in CIRCUIT and similar lifestyle intervention programs.",2021,"No group differences were observed for sex, ethnicity, baseline BMI z-score, fathers' education, or driving time to the program.","['older pediatric participants', '403 participants who started the program, 198 (49%) dropped out within 12 months of enrollment', 'pediatric healthy lifestyle intervention', 'children aged 4-18 years who initiated the CIRCUIT program in the first five years of its existence (N = 403']",['healthy lifestyle intervention program'],"[""sex, ethnicity, baseline BMI z-score, fathers' education, or driving time to the program""]","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",403.0,0.015987,"No group differences were observed for sex, ethnicity, baseline BMI z-score, fathers' education, or driving time to the program.","[{'ForeName': 'Prince Kevin', 'Initials': 'PK', 'LastName': 'Danieles', 'Affiliation': 'Research Center of CHU Sainte Justine, Université de Montréal 3175 chemin de la Côte-Sainte-Catherine, Montréal, Quebec H3T 1C5, Canada; Department of Mathematics and Statistics, Concordia University 1455 boulevard de Maisonneuve Ouest, Montréal, Quebec H3G 1M8, Canada.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Ybarra', 'Affiliation': 'Research Center of CHU Sainte Justine, Université de Montréal 3175 chemin de la Côte-Sainte-Catherine, Montréal, Quebec H3T 1C5, Canada.'}, {'ForeName': 'Andraea', 'Initials': 'A', 'LastName': 'Van Hulst', 'Affiliation': 'Ingram School of Nursing, McGill University 680 rue Sherbrooke Ouest, Montréal, Quebec H3A 2M7, Canada.'}, {'ForeName': 'Tracie A', 'Initials': 'TA', 'LastName': 'Barnett', 'Affiliation': 'Research Center of CHU Sainte Justine, Université de Montréal 3175 chemin de la Côte-Sainte-Catherine, Montréal, Quebec H3T 1C5, Canada; Department of Family Medicine, McGill University 5858 chemin de la Côte-des-Neiges, Montréal, Quebec H3S 1Z1, Canada.'}, {'ForeName': 'Marie-Ève', 'Initials': 'MÈ', 'LastName': 'Mathieu', 'Affiliation': 'Research Center of CHU Sainte Justine, Université de Montréal 3175 chemin de la Côte-Sainte-Catherine, Montréal, Quebec H3T 1C5, Canada; School of Kinesiology and Physical Activity Sciences, Université de Montréal 2100 boulevard Edouard Montpetit, Montréal, Quebec H3T 1J4, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Kakinami', 'Affiliation': 'Department of Mathematics and Statistics, Concordia University 1455 boulevard de Maisonneuve Ouest, Montréal, Quebec H3G 1M8, Canada; PERFORM Centre, Concordia University 7141 rue Sherbrooke Ouest, Montréal, Quebec H4B 1R6, Canada.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Drouin', 'Affiliation': 'Research Center of CHU Sainte Justine, Université de Montréal 3175 chemin de la Côte-Sainte-Catherine, Montréal, Quebec H3T 1C5, Canada; Department of Pediatrics, Université de Montréal 3175 chemin de la Côte-Sainte-Catherine, Montréal, Quebec H3T 1C5, Canada.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Bigras', 'Affiliation': 'Research Center of CHU Sainte Justine, Université de Montréal 3175 chemin de la Côte-Sainte-Catherine, Montréal, Quebec H3T 1C5, Canada; Department of Pediatrics, Université de Montréal 3175 chemin de la Côte-Sainte-Catherine, Montréal, Quebec H3T 1C5, Canada.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Henderson', 'Affiliation': 'Research Center of CHU Sainte Justine, Université de Montréal 3175 chemin de la Côte-Sainte-Catherine, Montréal, Quebec H3T 1C5, Canada; Department of Pediatrics, Université de Montréal 3175 chemin de la Côte-Sainte-Catherine, Montréal, Quebec H3T 1C5, Canada. Electronic address: melanie.henderson.hsj@gmail.com.'}]",Obesity research & clinical practice,['10.1016/j.orcp.2021.01.007'] 2231,33607462,Effects of increased attention allocation to threat and safety stimuli on fear extinction and its recall.,"BACKGROUND AND OBJECTIVES Attention plays an important role in the treatment of anxiety. Increased attention to threat has been shown to yield improved treatment outcomes in anxious patients following exposure-based therapy. This study examined whether increasing attention to learned stimuli during fear extinction, an experimental analogue for exposure-based treatments, could improve extinction learning and its maintenance. METHODS Sixty-five healthy adults were randomized into experimental or control conditions. All completed a differential fear conditioning task. During extinction, a subtle attentional manipulation was implemented in the experimental group, designed to increase participants' attention to both threat and safety cues. Three days later, an extinction recall test was conducted using the original cues and two perceptually similar morphs. RESULTS Fear conditioning was achieved in both behavioral and psychophysiological measures. In addition, between-group differences emerged during extinction. The experimental group exhibited increased attention to stimuli and lower fear responses in physiological measure than the control group. Similarly, during extinction recall, the experimental group exhibited lower startle responses than the control group. Last, across groups, attending to the safety cue during extinction was associated with lower self-reported risk of the two generalization morphs displayed during extinction recall. LIMITATIONS Skin conductance response (SCR) was not measured during extinction recall. Future research should include both SCR and additional generalization morphs so as to allow for the examination of more subtle individual differences. CONCLUSIONS Results indicate that the attentional manipulation increased attention allocation to stimuli during extinction; this, in turn, affected fear-related physiological response.",2021,The experimental group exhibited increased attention to stimuli and lower fear responses in physiological measure than the control group.,['Sixty-five healthy adults'],[],"['startle responses', 'fear extinction and its recall', 'attention to stimuli and lower fear responses']","[{'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]",[],"[{'cui': 'C0038186', 'cui_str': 'Startle Reaction'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",65.0,0.0226257,The experimental group exhibited increased attention to stimuli and lower fear responses in physiological measure than the control group.,"[{'ForeName': 'Zohar', 'Initials': 'Z', 'LastName': 'Klein', 'Affiliation': 'School of Psychological Sciences and the Integrated Brain and Behavior Research Center, University of Haifa, Abba Hushi 199, Mt Carmel, Haifa, Israel.'}, {'ForeName': 'Rivkah', 'Initials': 'R', 'LastName': 'Ginat-Frolich', 'Affiliation': 'School of Psychological Sciences and the Integrated Brain and Behavior Research Center, University of Haifa, Abba Hushi 199, Mt Carmel, Haifa, Israel.'}, {'ForeName': 'Tom J', 'Initials': 'TJ', 'LastName': 'Barry', 'Affiliation': ""Department of Psychology, The University of Hong Kong, Hong Kong. the Institute of Psychiatry, Psychology, & Neuroscience, King's College, London, UK.""}, {'ForeName': 'Tomer', 'Initials': 'T', 'LastName': 'Shechner', 'Affiliation': 'School of Psychological Sciences and the Integrated Brain and Behavior Research Center, University of Haifa, Abba Hushi 199, Mt Carmel, Haifa, Israel. Electronic address: tshechner@psy.haifa.ac.il.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2021.101640'] 2232,33607371,The position of urethrovesical anastomosis after robotic radical prostatectomy assessed by MRI predicts early functional recovery: A cohort analyses from a randomized clinical trial.,"PURPOSE Functional and anatomical changes associated with prostate removal coincide with alterations in pelvic structures. Posterior rhabdosphincter reconstruction was designed to improve urinary continence after radical prostatectomy. The aim of this study was to determine magnetic resonance anatomic predictors of urinary recovery after radical prostatectomy, and to assess their relation to the type of reconstruction. MATERIAL AND METHODS Forty patients were randomly selected from a trial (NCT03302169). Two independent radiologists determined the situation of the anastomosis in the pelvis according to MRI performed a month after the radical prostatectomy: vertical situation assessed as the distance to the line coccyx-inferior pubic margin (ACPv) and anteroposterior situation as the distance from the pubis (Distance A), and from the coccyx (Distance B). RESULTS The Pearson correlation of ACPv, Distance A, and B between readers were 0.975, 0.940, and 0.711, p < 0.001. Patients with the reconstruction presented more cephalic situation of the anastomosis (higher ACPv) than patients with standard reconstruction technique. A multivariate analysis was performed including age, BMI, prostate volume, PRRS, and the MRI parameters. ACPv and Distance B were the only two independent predictors of no need for any urinary protection at 6 months after the surgery. CONCLUSIONS This is the first study that suggests positional differences according to the type of reconstruction after radical prostatectomy related to early urinary recovery. Magnetic resonance measurements to determine anastomosis positioning are reliable and have a strong correlation between readers. Anatomic MRI features are independent predictors of urinary recovery after robotic radical prostatectomy.",2021,"ACPv and Distance B were the only two independent predictors of no need for any urinary protection at 6 months after the surgery. ",['Forty patients'],"['robotic radical prostatectomy assessed by MRI', 'radical prostatectomy', 'robotic radical prostatectomy', 'Posterior rhabdosphincter reconstruction']","['Pearson correlation of ACPv, Distance A, and B between readers', 'urinary continence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}]","[{'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0542565', 'cui_str': 'Bladder control'}]",40.0,0.0228705,"ACPv and Distance B were the only two independent predictors of no need for any urinary protection at 6 months after the surgery. ","[{'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Regis', 'Affiliation': ""Department of Urology, Vall d'Hebron University Hospital, Pg Vall d'Hebron 119, 08035, Barcelona, Spain; Universitat Autònoma de Barcelona, UAB, Campus de la UAB, Plaça Cívica, 08193, Bellaterra, Barcelona, Spain. Electronic address: lregis@vheborn.net.""}, {'ForeName': 'Aina', 'Initials': 'A', 'LastName': 'Salazar', 'Affiliation': ""Department of Urology, Vall d'Hebron University Hospital, Pg Vall d'Hebron 119, 08035, Barcelona, Spain; Universitat Autònoma de Barcelona, UAB, Campus de la UAB, Plaça Cívica, 08193, Bellaterra, Barcelona, Spain. Electronic address: aina.salazar@gmail.com.""}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Planas', 'Affiliation': ""Department of Urology, Vall d'Hebron University Hospital, Pg Vall d'Hebron 119, 08035, Barcelona, Spain; Universitat Autònoma de Barcelona, UAB, Campus de la UAB, Plaça Cívica, 08193, Bellaterra, Barcelona, Spain. Electronic address: jplanas@vhebron.net.""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Celma', 'Affiliation': ""Department of Urology, Vall d'Hebron University Hospital, Pg Vall d'Hebron 119, 08035, Barcelona, Spain; Universitat Autònoma de Barcelona, UAB, Campus de la UAB, Plaça Cívica, 08193, Bellaterra, Barcelona, Spain. Electronic address: acelma@vhebron.net.""}, {'ForeName': 'Merce', 'Initials': 'M', 'LastName': 'Cuadras', 'Affiliation': ""Department of Urology, Vall d'Hebron University Hospital, Pg Vall d'Hebron 119, 08035, Barcelona, Spain; Universitat Autònoma de Barcelona, UAB, Campus de la UAB, Plaça Cívica, 08193, Bellaterra, Barcelona, Spain. Electronic address: mcuadras@vhebron.net.""}, {'ForeName': 'Sarai', 'Initials': 'S', 'LastName': 'Roche', 'Affiliation': ""Department of Radiology, Vall d'Hebron University Hospital, Pg Vall d'Hebron 119, 08035, Barcelona, Spain. Electronic address: sarai.roche@idi.gencat.cat.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Mast', 'Affiliation': ""Department of Radiology, Vall d'Hebron University Hospital, Pg Vall d'Hebron 119, 08035, Barcelona, Spain. Electronic address: richard.mast.idi@gencat.cat.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Morote', 'Affiliation': ""Department of Urology, Vall d'Hebron University Hospital, Pg Vall d'Hebron 119, 08035, Barcelona, Spain; Universitat Autònoma de Barcelona, UAB, Campus de la UAB, Plaça Cívica, 08193, Bellaterra, Barcelona, Spain. Electronic address: jmorote@vhebron.net.""}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Trilla', 'Affiliation': ""Department of Urology, Vall d'Hebron University Hospital, Pg Vall d'Hebron 119, 08035, Barcelona, Spain; Universitat Autònoma de Barcelona, UAB, Campus de la UAB, Plaça Cívica, 08193, Bellaterra, Barcelona, Spain. Electronic address: etrilla@vhebron.net.""}]",European journal of radiology,['10.1016/j.ejrad.2021.109589'] 2233,33607215,The effect of GB21 acupressure on pain intensity in the first stage of labor in primiparous women: A randomized controlled trial.,"INTRODUCTION Labor pain is one of the most intensive pains experienced by women; it results in physical, emotional, and physiological changes in women's body. The present study aimed to examine the effect of GB21 acupressure on labor pain. DESIGN In this randomized clinical trial, 174 primiparous women in their first stage of labor were selected and assigned to three groups: GB21 acupressure group (n = 58), sham group (n = 58), and control group (n = 58). INTERVENTIONS The acupressure and sham groups received routine labor care and acupressure in three different phases of cervical dilations to 3-5 cm, 6-7 cm, and 8-10 cm. The control group received routine care in labor. MAIN OUTCOME MEASURES Pain severity was measured using a pain scale ruler in three cervical dilations before and after intervention. The collected data were analyzed using the ANOVA, Kruskal-Wallis, paired-t test and Mann-Whitney tests. RESULTS Pain reduction was significantly higher in GB21 groups compared with sham and control groups (P = 0.001). No statistically significant difference was observed between the three groups in terms of delivery outcomes. CONCLUSIONS In this study, GB21 acupressure was effective in pain relief during labor, hence recommended as a practical, effective, inexpensive, and accessible method for labor pain management.",2021,"RESULTS Pain reduction was significantly higher in GB21 groups compared with sham and control groups (P = 0.001).","['primiparous women', '174 primiparous women in their first stage of labor']","['GB21 acupressure', 'routine care in labor', 'acupressure and sham groups received routine labor care and acupressure']","['pain relief', 'Pain reduction', 'pain intensity', 'delivery outcomes', 'Pain severity']","[{'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0022871', 'cui_str': 'First stage of labor'}]","[{'cui': 'C0450741', 'cui_str': 'GB21'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1171200', 'cui_str': 'Labor care'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",174.0,0.0748518,"RESULTS Pain reduction was significantly higher in GB21 groups compared with sham and control groups (P = 0.001).","[{'ForeName': 'Hamideh', 'Initials': 'H', 'LastName': 'Torkiyan', 'Affiliation': 'Student Research Committee, Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: iranifarvahar@gmail.com.'}, {'ForeName': 'Sedigheh', 'Initials': 'S', 'LastName': 'Sedigh Mobarakabadi', 'Affiliation': 'Department of Midwifery and Reproductive Health, Midwifery and Reproductive Health Research Center, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: Sedighehsedigh@gmail.com.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Heshmat', 'Affiliation': 'Iranian Scientific Acupuncture Association, Tehran, Iran. Electronic address: heshmat@tebbessozani.com.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Khajavi', 'Affiliation': 'Department of Biostatistics, School of Paramedical Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: khajavi.student@gmail.com.'}, {'ForeName': 'Giti', 'Initials': 'G', 'LastName': 'Ozgoli', 'Affiliation': 'Department of Midwifery and Reproductive Health, Midwifery and Reproductive Health Research Center, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: gozgoli@sbmu.ac.ir.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2021.102683'] 2234,33609973,Impact of high-risk features for stage II adenocarcinoma of the appendix.,"BACKGROUND Clinico-pathological high-risk features are frequently utilized in adjuvant chemotherapy (AC) decisions in stage II colorectal cancer and their utility in stage II appendiceal adenocarcinoma (AA) is not established. The aim of this study is to determine the impact of high-risk features in clinical outcomes and whether high risk features are predictive of AC benefit in stage II AA. METHODS Patients with pathological stage II AA between 2010 and 2015 were identified from the National Cancer Database (NCDB) using ICD-O-3 morphology and topography codes: 8140, 8480 and C18.1. High risk stage II AA was defined as having at least one of the following clinicopathological features: T4 tumor, <12 lymph nodes examined, poorly differentiated histology, positive margins, or lymphovascular invasion. Patients with none of these features were defined as low-risk. RESULTS A total of 1040 patients with pathological stage II AA were identified. 51.0% males, 84.5% Caucasian; median age 61 (range, 19-90). 46.4% were determined to have high-risk stage II AA. High-risk status was associated with worse OS compared to low-risk in univariate (HR 1.55; 95% CI 1.18-2.02; p = 0.001) and multivariable analyses (HR 1.36; 95% CI 1.03-1.79; p = 0.028). High-risk stage II AA patients had significantly worse 5-year OS compared to low-risk patients (67.1% vs. 74.5%, p = 0.0013). AC was administered in 34.4% (n = 166) of high-risk patients and in 36.5% (n = 203) of low-risk patients. Among high-risk patients, AC was not associated with better OS in univariate (HR 0.86; 95% CI 0.59-1.26; p = 0.448) and multivariable analyses (HR 1.35; 95% CI 0.90-2.04; p = 0.151) compared to no AC. Similarly, among low-risk patients, AC was not associated with better OS in univariate (HR 0.92; 95% CI 0.60-1.39; p = 0.679) and multivariable analyses (HR 1.27; 95% CI 0.81-2.02; p = 0.299) compared to no AC. For high-risk patients, 5-year OS was 68.3% in patients that received AC vs. 66.5% in patients that did not (p = 0.722). For low-risk patients, 5-year OS was 74.0% in patients that received AC vs. 76.3% in patients that did not (p = 0.813). CONCLUSION High-risk stage II AA patients had significantly worse 5-year OS compared to low-risk patients. AC did not improve survival regardless of high-risk features in stage II AA in this retrospective study. A prospective randomized clinical trial would be required to determine the impact of high-risk features on AC in stage II AA.",2021,"For high-risk patients, 5-year OS was 68.3% in patients that received AC vs. 66.5% in patients that did not (p = 0.722).","['203) of low-risk patients', '51.0% males, 84.5% Caucasian; median age 61 (range, 19-90', '1040 patients with pathological stage II AA', 'stage II adenocarcinoma of the appendix', 'Patients with pathological stage II AA between 2010 and 2015 were identified from the National Cancer Database (NCDB) using ICD-O-3 morphology and topography codes: 8140, 8480 and C18.1']",[],"['High risk stage II AA', '5-year OS', 'High-risk stage']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0238003', 'cui_str': 'Adenocarcinoma of appendix'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0020725', 'cui_str': 'I-cell disease'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0009219', 'cui_str': 'Coding'}]",[],"[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",1040.0,0.29023,"For high-risk patients, 5-year OS was 68.3% in patients that received AC vs. 66.5% in patients that did not (p = 0.722).","[{'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Akce', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA. Electronic address: mehmet.akce@emory.edu.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Zakka', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'McKenna', 'Initials': 'M', 'LastName': 'Penley', 'Affiliation': 'Winship Research Informatics, Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Renjian', 'Initials': 'R', 'LastName': 'Jiang', 'Affiliation': 'Winship Research Informatics, Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Lana', 'Initials': 'L', 'LastName': 'Khalil', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Olatunji B', 'Initials': 'OB', 'LastName': 'Alese', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Walid L', 'Initials': 'WL', 'LastName': 'Shaib', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Madhusmita', 'Initials': 'M', 'LastName': 'Behera', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA; Winship Research Informatics, Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Bassel F', 'Initials': 'BF', 'LastName': 'El-Rayes', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}]",Cancer treatment and research communications,['10.1016/j.ctarc.2021.100329'] 2235,33611164,Metronomic oral vinorelbine in previously untreated advanced non-small-cell lung cancer patients unfit for platinum-based chemotherapy: results of the randomized phase II Tempo Lung trial.,"BACKGROUND To assess the efficacy and safety of a metronomic schedule of oral vinorelbine (mVNR) in advanced non-small-cell lung cancer (NSCLC) in patients unfit for platinum-based combination chemotherapy. PATIENTS AND METHODS This was a multicenter, prospective, randomized, open-label phase II study in treatment-naive patients with TNM stage IIIB/IV NSCLC. Patients received mVNR at a fixed dose of 50 mg × 3 or standard schedule 60-80 mg/m 2 weekly until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS) without grade 4 toxicity (G4PFS; NCI-CTC v4). Main secondary objectives were safety, disease control rate (DCR) without grade 4 toxicity (G4DCR), DCR, PFS, overall survival (OS) and quality of life (QoL). RESULTS A total of 167 patients were included, 83 and 84 patients in the mVNR and standard arms, respectively. The median G4PFS was 4.0 months [95% confidence interval (CI): 2.6-4.3] and 2.2 months (95% CI: 1.5-2.9), hazard ration (HR) = 0.63 (95% CI: 0.45-0.88), P = 0.0068 in favor of metronomic arm; G4DCR was 45.8% and 26.8% in the mVNR and standard arms, respectively. Grade 3-4 treatment-related adverse events were less frequent in the mVNR arm (25.3% versus 54.4%) mainly owing to a reduction in all grades (15.7% versus 51.9%) and grade 3-4 neutropenia (10.8% versus 42%). PFS was 4.3 (95% CI: 3.3-5.1) and 3.9 months (95% CI: 2.8-5.2) in mVNR and standard arms, respectively. No difference in median OS was observed. QoL was comparable between arms. CONCLUSIONS Metronomic oral vinorelbine significantly prolonged median G4PFS in advanced NSCLC patients unfit for platinum combinations as first-line treatment. It was associated with a clear reduction in toxicity and may be considered as an important option in this challenging population.",2021,"PFS was 4.3 (95% CI: 3.3-5.1) and 3.9 months (95% CI: 2.8-5.2) in mVNR and standard arms, respectively.","['A total of 167 patients were included, 83 and 84 patients in the mVNR and standard arms, respectively', 'treatment-naive patients with TNM stage IIIB/IV NSCLC', 'previously untreated advanced non-small-cell lung cancer patients unfit for', 'advanced non-small-cell lung cancer (NSCLC) in patients unfit for platinum-based combination chemotherapy', 'advanced NSCLC patients']","['oral vinorelbine (mVNR', 'platinum-based chemotherapy', 'Metronomic oral vinorelbine', 'mVNR']","['median G4PFS', 'PFS', 'progression-free survival (PFS) without grade 4 toxicity (G4PFS; NCI-CTC v4', 'grade 3-4 neutropenia', 'efficacy and safety', 'toxicity', 'median OS', 'adverse events', 'QoL', 'safety, disease control rate (DCR) without grade 4 toxicity (G4DCR), DCR, PFS, overall survival (OS) and quality of life (QoL']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0039694', 'cui_str': 'Tetranitromethane'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0560007', 'cui_str': 'nCi'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010931', 'cui_str': 'Dacryocystorhinostomy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",167.0,0.16936,"PFS was 4.3 (95% CI: 3.3-5.1) and 3.9 months (95% CI: 2.8-5.2) in mVNR and standard arms, respectively.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Camerini', 'Affiliation': 'Medical Oncology Department, Versilia Hospital, Lido di Camaiore, Italy. Electronic address: andrea.camerini@uslnordovest.toscana.it.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Morabito', 'Affiliation': 'Thoracic Medical Oncology, Istituto Nazionale Tumori, ""Fondazione G. Pascale"", IRCCS, Napoli, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Montanino', 'Affiliation': 'Thoracic Medical Oncology, Istituto Nazionale Tumori, ""Fondazione G. Pascale"", IRCCS, Napoli, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bernabé', 'Affiliation': 'Medical Oncology Department, Hospital Virgen del Rocio, Institute for Biomedical Research, Seville, Spain.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Grossi', 'Affiliation': ""Division of Medical Oncology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ramlau', 'Affiliation': 'Oncology Department, Poznan University of Medical Sciences, Poland.'}, {'ForeName': 'T-E', 'Initials': 'TE', 'LastName': 'Ciuleanu', 'Affiliation': 'Oncology Institute ""Pr Dr Ion Chiricuta"", Cluj-Napoca, Romania.'}, {'ForeName': 'G-L', 'Initials': 'GL', 'LastName': 'Ceresoli', 'Affiliation': 'Oncology Department, Cliniche Humanitas Gavazzeni, Bergamo, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Pasello', 'Affiliation': 'Oncology 2, Istituto Oncologico Veneto IRCCS, Padova, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'de Marinis', 'Affiliation': 'Thoracic Oncology Division, European Institute of Oncology, IRCCS, Milan, Italy.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bosch-Barrera', 'Affiliation': 'Lung Cancer Unit, Catalan Institute of Oncology, Hospital Universitari Dr Josep Trueta, Girona, Spain.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Laundreau', 'Affiliation': 'Medical Affairs Oncology, Pierre Fabre Médicament, Boulogne, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gautier', 'Affiliation': 'IRPF, Pierre Fabre Médicament, Toulouse, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ta Thanh Minh', 'Affiliation': 'Medical Affairs Oncology, Pierre Fabre Médicament, Boulogne, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kowalski', 'Affiliation': 'Lung Cancer and Chest Tumours Department, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland.'}]",ESMO open,['10.1016/j.esmoop.2021.100051'] 2236,33615803,Effects of 5-mg dose of olanzapine for breakthrough nausea and vomiting in patients receiving carboplatin-based chemotherapy: a prospective trial.,"BACKGROUND Olanzapine 10 mg is recommended for breakthrough chemotherapy-induced nausea and vomiting. However, there is a possibility that 5 mg can be expected to be sufficiently effective. We aimed to investigate the efficacy and safety of olanzapine 5 mg for breakthrough chemotherapy-induced nausea and vomiting. METHODS A single-arm prospective trial of olanzapine 5 mg every 24 h for 72 h was conducted to treat breakthrough chemotherapy-induced nausea and vomiting in patients receiving carboplatinbased chemotherapy. The primary endpoint was total control (i.e., no emesis, no nausea, and no rescue medications) over 72 h. The secondary endpoints were early efficacy using the nausea scores at 30, 60, and 120 min after taking olanzapine from baseline and adverse events. RESULTS Among 84 potentially eligible patients, 19 patients who took olanzapine for breakthrough chemotherapy-induced nausea and vomiting were examined. The total control rate was 32% (95% CI: 13- 57%), 65% (95% CI: 38-89%), 65% (95% CI: 38-89%), and 29% (95% CI: 10-56%) during 2-24, 24-48, 48-72 h, and overall period, respectively. The nausea scale significantly reduced after 30 min (P=0.0078), and the scale had been reduced by 67% from the baseline after 60 min. The adverse event of somnolence of any grade was observed in 13 (68%) patients, 6 (32%) of whom had grade 2 and 1 (5%) grade 3 somnolence. CONCLUSIONS Olanzapine 5 mg did not show the expected effect on the complete disappearance of breakthrough chemotherapy-induced nausea and vomiting within 24 h.",2021,"The nausea scale significantly reduced after 30 min (P=0.0078), and the scale had been reduced by 67% from the baseline after 60 min.","['patients receiving', '84 potentially eligible patients, 19 patients who took', 'patients receiving carboplatinbased chemotherapy']","['carboplatin-based chemotherapy', 'olanzapine', 'Olanzapine']","['nausea and vomiting', 'total control (i.e., no emesis, no nausea, and no rescue medications', 'nausea scores', 'adverse event of somnolence of any grade', 'total control rate', 'efficacy and safety', 'breakthrough nausea and vomiting', 'nausea scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0423584', 'cui_str': 'No nausea'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444503', 'cui_str': 'Breakthrough'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.115911,"The nausea scale significantly reduced after 30 min (P=0.0078), and the scale had been reduced by 67% from the baseline after 60 min.","[{'ForeName': 'Akimitsu', 'Initials': 'A', 'LastName': 'Maeda', 'Affiliation': 'Department of Pharmacy, Aichi Cancer Center Hospital, Nagoya, Aichi 464-8681, Japan. m.akimitsu@aichi-cc.jp.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Yoshida', 'Affiliation': 'Department of Pharmacy, Japanese Red Cross Nagoya Daini Hospital, Nagoya, Aichi 466-8650, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Inoue', 'Affiliation': 'Department of Pharmacy, National Hospital Organization Nagoya Medical Center, Nagoya, Aichi 460-0001, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Ejiri', 'Affiliation': 'Department of Pharmacy, Aichi Medical University, Nagakute, Aichi 480-1195, Japan.'}, {'ForeName': 'Satoe', 'Initials': 'S', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Pharmacy, Chubu Rosai Hospital, Minato-ku Nagoya, Aichi 455-8530, Japan.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Kushihara', 'Affiliation': 'Department of Pharmacy, Japanese Red Cross Nagoya Daiichi Hospital, Nagoya, Aichi 453- 8511, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Pharmacy, Komaki City Hospital, Komaki, Aichi 485-8520, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Ando', 'Affiliation': 'Department of Clinical Pharmacy, Fujita Health University School of Medicine, Toyoake, Aichi 470-1192, Japan.'}, {'ForeName': 'Yumiko', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Department of Pharmacy, Nagoya City West Medical Center, Nagoya, Aichi 462- 8508, Japan.'}, {'ForeName': 'Yuusuke', 'Initials': 'Y', 'LastName': 'Tashiro', 'Affiliation': 'Department of Pharmacy, Nagoya City University Hospital, Nagoya, Aichi 467-8602, Japan.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Pharmacy, Aichi Cancer Center Hospital, Nagoya, Aichi 464-8681, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Takahara', 'Affiliation': 'Department of Pharmacy, Japanese Red Cross Nagoya Daini Hospital, Nagoya, Aichi 466-8650, Japan.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Mizutani', 'Affiliation': 'Department of Pharmacy, National Hospital Organization Nagoya Medical Center, Nagoya, Aichi 460-0001, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Oze', 'Affiliation': 'Division of Cancer Epidemiology and Prevention, Aichi Cancer Center Research Institute, Nagoya, Aichi 464-8681, Japan.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Shimizu', 'Affiliation': 'Department of Thoracic Oncology, Aichi Cancer Center Hospital, Nagoya, Aichi 464-8681, Japan.'}]",Annals of palliative medicine,['10.21037/apm-20-1784'] 2237,33617303,TRANSFORMER: A Randomized Phase II Study Comparing Bipolar Androgen Therapy Versus Enzalutamide in Asymptomatic Men With Castration-Resistant Metastatic Prostate Cancer.,"PURPOSE Prostate cancer (PCa) becomes resistant to androgen ablation through adaptive upregulation of the androgen receptor in response to the low-testosterone microenvironment. Bipolar androgen therapy (BAT), defined as rapid cycling between high and low serum testosterone, disrupts this adaptive regulation in castration-resistant PCa (CRPC). METHODS The TRANSFORMER (Testosterone Revival Abolishes Negative Symptoms, Fosters Objective Response and Modulates Enzalutamide Resistance) study is a randomized study comparing monthly BAT (n = 94) with enzalutamide (n = 101). The primary end point was clinical or radiographic progression-free survival (PFS); crossover was permitted at progression. Secondary end points included overall survival (OS), prostate-specific antigen (PSA) and objective response rates, PFS from randomization through crossover (PFS2), safety, and quality of life (QoL). RESULTS The PFS was 5.7 months for both arms (hazard ratio [HR], 1.14; 95% CI, 0.83 to 1.55; P = .42). For BAT, 50% decline in PSA (PSA50) was 28.2% of patients versus 25.3% for enzalutamide. At crossover, PSA50 response occurred in 77.8% of patients crossing to enzalutamide and 23.4% to BAT. The PSA-PFS for enzalutamide increased from 3.8 months after abiraterone to 10.9 months after BAT. The PFS2 for BAT→enzalutamide was 28.2 versus 19.6 months for enzalutamide→BAT (HR, 0.44; 95% CI, 0.22 to 0.88; P = .02). OS was 32.9 months for BAT versus 29.0 months for enzalutamide (HR, 0.95; 95% CI, 0.66 to 1.39; P = .80). OS was 37.1 months for patients crossing from BAT to enzalutamide versus 30.2 months for the opposite sequence (HR, 0.68; 95% CI, 0.36 to 1.28; P = .225). BAT adverse events were primarily grade 1-2. Patient-reported QoL consistently favored BAT. CONCLUSION This randomized trial establishes meaningful clinical activity and safety of BAT and supports additional study to determine its optimal clinical integration. BAT can sensitize CRPC to subsequent antiandrogen therapy. Further study is required to confirm whether sequential therapy with BAT and enzalutamide can improve survival in men with CRPC.",2021,"The PFS2 for BAT→enzalutamide was 28.2 versus 19.6 months for enzalutamide→BAT (HR, 0.44; 95% CI, 0.22 to 0.88; P = .02).","['Asymptomatic Men', 'men with CRPC', 'n = 94) with enzalutamide (n = 101']","['Bipolar Androgen Therapy Versus Enzalutamide', 'BAT', 'Bipolar androgen therapy (BAT', 'BAT and enzalutamide']","['clinical or radiographic progression-free survival (PFS', 'PSA50 response', 'survival', 'overall survival (OS), prostate-specific antigen (PSA) and objective response rates, PFS from randomization through crossover (PFS2), safety, and quality of life (QoL', 'PFS2 for BAT→enzalutamide', 'BAT adverse events', 'PSA (PSA50', 'PSA-PFS for enzalutamide']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0007344', 'cui_str': 'Gonadectomy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0030131', 'cui_str': 'p-Chloramphetamine'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}]","[{'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0279493', 'cui_str': 'Androgen therapy'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}, {'cui': 'C0279493', 'cui_str': 'Androgen therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}]",94.0,0.104314,"The PFS2 for BAT→enzalutamide was 28.2 versus 19.6 months for enzalutamide→BAT (HR, 0.44; 95% CI, 0.22 to 0.88; P = .02).","[{'ForeName': 'Samuel R', 'Initials': 'SR', 'LastName': 'Denmeade', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Agarwal', 'Affiliation': 'The Huntsman Cancer Institute, Salt Lake City, UT.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Smith', 'Affiliation': 'The University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Schweizer', 'Affiliation': 'The University of Washington, Seattle, WA.'}, {'ForeName': 'Mark N', 'Initials': 'MN', 'LastName': 'Stein', 'Affiliation': 'Rutgers University, New Brunswick, NJ.'}, {'ForeName': 'Vasileios', 'Initials': 'V', 'LastName': 'Assikis', 'Affiliation': 'Piedmont Cancer Institute, Atlanta, GA.'}, {'ForeName': 'Przemyslaw W', 'Initials': 'PW', 'LastName': 'Twardowski', 'Affiliation': 'City of Hope Cancer Center, Duarte, CA.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Flaig', 'Affiliation': 'University of Colorado, Aurora, CO.'}, {'ForeName': 'Russell Z', 'Initials': 'RZ', 'LastName': 'Szmulewitz', 'Affiliation': 'University of Chicago, Chicago, IL.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Holzbeierlein', 'Affiliation': 'University of Kansas, Kansas City, KA.'}, {'ForeName': 'Ralph J', 'Initials': 'RJ', 'LastName': 'Hauke', 'Affiliation': 'Nebraska Cancer Specialists, Omaha, NE.'}, {'ForeName': 'Guru', 'Initials': 'G', 'LastName': 'Sonpavde', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Garcia', 'Affiliation': 'The Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Hussain', 'Affiliation': 'The University of Maryland, Baltimore, MD.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Sartor', 'Affiliation': 'Tulane University, New Orleans, LA.'}, {'ForeName': 'Shifeng', 'Initials': 'S', 'LastName': 'Mao', 'Affiliation': 'Allegheny General Hospital, Pittsburgh, PA.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Fu', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.'}, {'ForeName': 'Rehab', 'Initials': 'R', 'LastName': 'Abdallah', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.'}, {'ForeName': 'Su Jin', 'Initials': 'SJ', 'LastName': 'Lim', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Bolejack', 'Affiliation': 'Cancer Research and Biostatistics, Seattle, WA.'}, {'ForeName': 'Channing J', 'Initials': 'CJ', 'LastName': 'Paller', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Carducci', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Markowski', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.'}, {'ForeName': 'Mario A', 'Initials': 'MA', 'LastName': 'Eisenberger', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.'}, {'ForeName': 'Emmanuel S', 'Initials': 'ES', 'LastName': 'Antonarakis', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.02759'] 2238,33625939,Muscarinic receptor blockade causes postcontraction enhancement in corticospinal excitability following maximal contractions.,"Although s ynaptic transmission in motor pathways can be regulated by neuromodulators, such as acetylcholine, few studies have examined how cholinergic activity affects cortical and spinal motor circuits following muscle contractions of varying intensities. This was a human, double-blinded, placebo-controlled, crossover study. Participants attended two sessions where they were administered either a placebo or 25 mg of promethazine. Electromyography of the abductor digiti minimi (ADM) was measured for all conditions. Motor evoked potentials (MEPs) were obtained via motor cortical transcranial magnetic stimulation (TMS), and F waves were obtained via ulnar nerve electrical stimulation. MEPs and F waves were examined: 1 ) when the muscle was at rest; 2 ) after the muscle had been active; and 3 ) after the muscle had been fatigued. MEPs were unaffected by muscarinic receptor blockade when measurements were recorded from resting muscle or following a 50% isometric maximal voluntary contraction (MVC). However, muscarinic receptor blockade increased MEP area following a 10-s MVC ( P = 0.019) and following a fatiguing 60-s MVC ( P = 0.040). F wave area and persistence were not affected by promethazine for any muscle contraction condition. Corticospinal excitability was influenced by cholinergic effects when voluntary drive to the muscle was high. Given that spinal motoneurone excitability remained unaffected, it is likely that cholinergic effects are influential within the motor cortex during strong muscle contractions. Future research should evaluate how cholinergic effects alter the relationship between subcortical structures and the motor cortex, as well as brainstem neuromodulatory pathways and spinal motoneurons. NEW & NOTEWORTHY The relationship between motor function and cholinergic circuitry in the central nervous system is complex. Although many studies have approached this issue at the cellular level, few studies have examined cholinergic mechanisms in humans performing muscle contractions. This study demonstrates that blockade of muscarinic acetylcholine receptors enhances motor evoked potentials (elicited with transcranial magnetic stimulation) following strong muscle contractions, but not weak muscle contractions.",2021,"However, muscarinic receptor blockade increased MEP area following a 10 s MVC (p = 0.019) and following a fatiguing 60 s MVC (p = 0.040).",[],"['promethazine', 'placebo', 'Motor evoked potentials (MEPs) were obtained via motor cortical transcranial magnetic stimulation (TMS), and F waves were obtained via ulnar nerve electrical stimulation']","['MEP area', 'Electromyography of the abductor digiti minimi (ADM']",[],"[{'cui': 'C0033405', 'cui_str': 'Promethazine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0041602', 'cui_str': 'Structure of ulnar nerve'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0054871', 'cui_str': 'Cathepsin L'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}]",,0.265182,"However, muscarinic receptor blockade increased MEP area following a 10 s MVC (p = 0.019) and following a fatiguing 60 s MVC (p = 0.040).","[{'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Dempsey', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Justin J', 'Initials': 'JJ', 'LastName': 'Kavanagh', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia.'}]",Journal of neurophysiology,['10.1152/jn.00673.2020'] 2239,33630043,Balanced Opioid-free Anesthesia with Dexmedetomidine versus Balanced Anesthesia with Remifentanil for Major or Intermediate Noncardiac Surgery.,"BACKGROUND It is speculated that opioid-free anesthesia may provide adequate pain control while reducing postoperative opioid consumption. However, there is currently no evidence to support the speculation. The authors hypothesized that opioid-free balanced anesthetic with dexmedetomidine reduces postoperative opioid-related adverse events compared with balanced anesthetic with remifentanil. METHODS Patients were randomized to receive a standard balanced anesthetic with either intraoperative remifentanil plus morphine (remifentanil group) or dexmedetomidine (opioid-free group). All patients received intraoperative propofol, desflurane, dexamethasone, lidocaine infusion, ketamine infusion, neuromuscular blockade, and postoperative lidocaine infusion, paracetamol, nefopam, and patient-controlled morphine. The primary outcome was a composite of postoperative opioid-related adverse events (hypoxemia, ileus, or cognitive dysfunction) within the first 48 h after extubation. The main secondary outcomes were episodes of postoperative pain, opioid consumption, and postoperative nausea and vomiting. RESULTS The study was stopped prematurely because of five cases of severe bradycardia in the dexmedetomidine group. The primary composite outcome occurred in 122 of 156 (78%) dexmedetomidine group patients compared with 105 of 156 (67%) in the remifentanil group (relative risk, 1.16; 95% CI, 1.01 to 1.33; P = 0.031). Hypoxemia occurred 110 of 152 (72%) of dexmedetomidine group and 94 of 155 (61%) of remifentanil group patients (relative risk, 1.19; 95% CI, 1.02 to 1.40; P = 0.030). There were no differences in ileus or cognitive dysfunction. Cumulative 0 to 48 h postoperative morphine consumption (11 mg [5 to 21] versus 6 mg [0 to 17]) and postoperative nausea and vomiting (58 of 157 [37%] versus 37 of 157 [24%]; relative risk, 0.64; 95% CI, 0.45 to 0.90) were both less in the dexmedetomidine group, whereas measures of analgesia were similar in both groups. Dexmedetomidine patients had more delayed extubation and prolonged postanesthesia care unit stay. CONCLUSIONS This trial refuted the hypothesis that balanced opioid-free anesthesia with dexmedetomidine, compared with remifentanil, would result in fewer postoperative opioid-related adverse events. Conversely, it did result in a greater incidence of serious adverse events, especially hypoxemia and bradycardia. EDITOR’S PERSPECTIVE ",2021,There were no differences in ileus or cognitive dysfunction.,['Patients'],"['dexmedetomidine', 'Dexmedetomidine', 'standard balanced anesthetic with either intraoperative remifentanil plus morphine (remifentanil group) or dexmedetomidine (opioid-free group', 'remifentanil', 'Dexmedetomidine versus Balanced Anesthesia with Remifentanil', 'intraoperative propofol, desflurane, dexamethasone, lidocaine infusion, ketamine infusion, neuromuscular blockade, and postoperative lidocaine infusion, paracetamol, nefopam, and patient-controlled morphine']","['ileus or cognitive dysfunction', 'Cumulative 0 to 48 h postoperative morphine consumption', 'composite of postoperative opioid-related adverse events (hypoxemia, ileus, or cognitive dysfunction', 'episodes of postoperative pain, opioid consumption, and postoperative nausea and vomiting', 'severe bradycardia', 'delayed extubation and prolonged postanesthesia care unit stay', 'serious adverse events, especially hypoxemia and bradycardia', 'Hypoxemia', 'postoperative nausea and vomiting', 'analgesia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C2936341', 'cui_str': 'Balanced Anesthesia'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0234119', 'cui_str': 'Neuromuscular blockade'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0027556', 'cui_str': 'Nefopam'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1258215', 'cui_str': 'Ileus'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",,0.209579,There were no differences in ileus or cognitive dysfunction.,"[{'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Beloeil', 'Affiliation': ''}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Garot', 'Affiliation': ''}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Lebuffe', 'Affiliation': ''}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Gerbaud', 'Affiliation': ''}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Bila', 'Affiliation': ''}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Cuvillon', 'Affiliation': ''}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Dubout', 'Affiliation': ''}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Oger', 'Affiliation': ''}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Nadaud', 'Affiliation': ''}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Becret', 'Affiliation': ''}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Coullier', 'Affiliation': ''}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Lecoeur', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Fayon', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Godet', 'Affiliation': ''}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Mazerolles', 'Affiliation': ''}, {'ForeName': 'Fouad', 'Initials': 'F', 'LastName': 'Atallah', 'Affiliation': ''}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Sigaut', 'Affiliation': ''}, {'ForeName': 'Pierre-Marie', 'Initials': 'PM', 'LastName': 'Choinier', 'Affiliation': ''}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Asehnoune', 'Affiliation': ''}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Roquilly', 'Affiliation': ''}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Chanques', 'Affiliation': ''}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Esvan', 'Affiliation': ''}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Futier', 'Affiliation': ''}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Laviolle', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003725'] 2240,33629973,Use of Gloves to Examine Intermittent Palm Cooling's Impact on Rowing Ergometry.,"ABSTRACT O'Brien, IT, Kozerski, AE, Gray, WD, Chen, L, Vargas, LJ, McEnroe, CB, Vanhoover, AC, King, KM, Pantalos, GM, and Caruso, JF. Use of gloves to examine intermittent palm cooling's impact on rowing ergometry. J Strength Cond Res 35(4): 931-940, 2021-The aim of this study was to examine the use of gloves on intermittent palm cooling's impact on rowing ergometry workouts. Our methods had subjects (n = 34) complete 3 rowing ergometer workouts of up to 8 2-minute stages separated by 45- or 60-second rests. They were randomized to one of the following treatments per workout: no palm cooling (NoPC), intermittent palm cooling as they rowed (PCex), or intermittent palm cooling as they rowed and post-exercise (PCex&post). Palm cooling entailed intermittent cold (initial temperature: 8.1° C) application and totaled 10 (PCex) and 20 (PCex&post) minutes, respectively. Workouts began with 8 minutes of rest after which pre-exercise data were obtained, followed by a ten-minute warm-up and the workout, and 20 minutes of post-exercise recovery. Numerous physiological and performance variables were collected before, during, and after workouts, and each was analyzed with either a two- or three-way analysis of variance. Our results include, with a 0.05 alpha and a simple effects post hoc, the distance rowed analysis produced a significant workout effect with PCex, PCex&post > NoPC. There were also significant interworkout differences for heart rate (HR) (NoPC > PCex) and blood lactate concentration (NoPC > PCex, PCex&post). We conclude that lower HRs and blood lactate concentrations from intermittent cooling caused subjects to experience less fatigue during those workouts and enabled more work to be performed. Continued research should identify optimal cooling characteristics to expedite body heat removal. Practical applications suggest that intermittent palm cooling administered with gloves enhance performance by abating physiological markers of fatigue.",2021,"There were also significant interworkout differences for heart rate (HR) (NoPC > PCex) and blood lactate concentration (NoPC > PCex, PCex&post).",[],"['Palm cooling entailed intermittent cold (initial temperature: 8.1° C) application and totaled 10 (PCex) and 20 (PCex&post', 'workout: no palm cooling (NoPC), intermittent palm cooling as they rowed (PCex), or intermittent palm cooling as they rowed and post-exercise (PCex&post', 'J Strength Cond Res XX(X']","['heart rate (HR) (NoPC > PCex) and blood lactate concentration (NoPC > PCex, PCex&post', 'lower HRs and blood lactate concentrations', 'rowing ergometry', 'Rowing Ergometry']",[],"[{'cui': 'C0230373', 'cui_str': 'Palm of hand (surface region)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0085143', 'cui_str': 'Ergometry'}]",,0.0583127,"There were also significant interworkout differences for heart rate (HR) (NoPC > PCex) and blood lactate concentration (NoPC > PCex, PCex&post).","[{'ForeName': 'Ian T', 'Initials': 'IT', 'LastName': ""O'Brien"", 'Affiliation': 'Exercise Physiology Program, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Kozerski', 'Affiliation': 'Exercise Physiology Program, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Gray', 'Affiliation': 'Exercise Physiology Program, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Exercise Physiology Program, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Liliana J', 'Initials': 'LJ', 'LastName': 'Vargas', 'Affiliation': 'Exercise Physiology Program, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'McEnroe', 'Affiliation': 'Exercise Physiology Program, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Alexandria C', 'Initials': 'AC', 'LastName': 'Vanhoover', 'Affiliation': 'Exercise Physiology Program, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Kristi M', 'Initials': 'KM', 'LastName': 'King', 'Affiliation': 'Exercise Physiology Program, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'George M', 'Initials': 'GM', 'LastName': 'Pantalos', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, Cardiovascular Innovation Institute, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Caruso', 'Affiliation': 'Exercise Physiology Program, University of Louisville, Louisville, Kentucky.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003561'] 2241,33629227,Phase 2 Randomized Clinical Study of Netarsudil Ophthalmic Solution in Japanese Patients with Primary Open-Angle Glaucoma or Ocular Hypertension.,"INTRODUCTION Netarsudil reduces intraocular pressure (IOP) by increasing aqueous outflow through the trabecular meshwork (TM) pathway and decreasing episcleral venous pressure. The primary objective of this phase 2 study was to evaluate ocular hypotensive efficacy and safety of three netarsudil concentrations (0.01%, 0.02%, and 0.04%) relative to its placebo over 4 weeks in Japanese patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT). METHODS Patients were randomized to one of four treatment arms, netarsudil ophthalmic solution 0.01%, 0.02%, 0.04%, or placebo, and treated once-daily (QD) in the evening (P.M.) for 4 weeks. The primary efficacy variable was mean diurnal IOP (average of diurnal time points at 9 A.M., 11 A.M., and 4 P.M.) at week 4. RESULTS A total of 215 patients were randomized and 207 (96.3%) completed the study. The mean of mean diurnal IOP at baseline ranged from 20.28 to 21.14 mmHg across groups. At week 4, least squares (LS) mean of mean diurnal IOP adjusted for baseline was 16.53, 15.82, 16.06, and 18.94 mmHg in the netarsudil 0.01%, 0.02%, 0.04%, and placebo groups, respectively, demonstrating the superiority of netarsudil (all concentrations) over placebo. At week 4, mean reduction (mean percentage reduction) from baseline in mean diurnal IOP was 4.10 (19.8%), 4.80 (23.5%), 4.81 (23.8%), and 1.73 mmHg (8.2%), respectively, demonstrating statistically significant reductions (p < 0.0001) in all netarsudil concentrations over placebo. Adverse events (AEs) occurred in a concentration-dependent manner, and the incidence of ocular AEs was 34.5%, 42.6%, 68.6%, and 9.1% in the netarsudil 0.01%, 0.02%, 0.04%, and placebo groups, respectively. The most frequently reported AE was conjunctival hyperemia, with an incidence of 23.6%, 37.0%, 56.9%, and 1.8%, respectively. No serious AEs were reported. CONCLUSION Netarsudil ophthalmic solutions 0.01%, 0.02%, and 0.04% dosed QD (P.M.) demonstrated superiority to placebo in terms of hypotensive effectiveness at week 4 and were found to be safe and generally well tolerated. Netarsudil 0.02% QD provided an optimal efficacy and safety profile for the treatment of Japanese patients with POAG or OHT. TRIAL REGISTRATION NCT03844945.",2021,"Adverse events (AEs) occurred in a concentration-dependent manner, and the incidence of ocular AEs was 34.5%, 42.6%, 68.6%, and 9.1% in the netarsudil 0.01%, 0.02%, 0.04%, and placebo groups, respectively.","['Patients', 'Japanese patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT', 'A total of 215 patients were randomized and 207 (96.3%) completed the study', 'Japanese Patients with Primary Open-Angle Glaucoma or Ocular Hypertension', 'Japanese patients with POAG or OHT']","['trabecular meshwork (TM', 'netarsudil ophthalmic solution', 'Netarsudil Ophthalmic Solution', 'placebo']","['hypotensive effectiveness', 'mean diurnal IOP (average of diurnal time points', 'incidence of ocular AEs', 'Adverse events (AEs', 'episcleral venous pressure', 'mean diurnal IOP', 'conjunctival hyperemia', 'optimal efficacy and safety profile', 'mean of mean diurnal IOP', 'Netarsudil reduces intraocular pressure (IOP', 'safe and generally well tolerated', 'ocular hypotensive efficacy and safety of three netarsudil concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C0028840', 'cui_str': 'Ocular hypertension'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0040573', 'cui_str': 'Trabecular meshwork structure'}, {'cui': 'C4535721', 'cui_str': 'netarsudil Ophthalmic Solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1827744', 'cui_str': 'Episcleral venous pressure'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4535718', 'cui_str': 'netarsudil'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",215.0,0.447732,"Adverse events (AEs) occurred in a concentration-dependent manner, and the incidence of ocular AEs was 34.5%, 42.6%, 68.6%, and 9.1% in the netarsudil 0.01%, 0.02%, 0.04%, and placebo groups, respectively.","[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Araie', 'Affiliation': 'Kanto Central Hospital of the Mutual Aid Association of Public School Teachers, Tokyo, Japan. m.araie-tky@nifty.com.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Sugiyama', 'Affiliation': 'Department of Ophthalmology, Kanazawa University Graduate School of Medical Science, Kanazawa, Ishikawa, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Aso', 'Affiliation': 'Aerie Pharmaceuticals Ireland Ltd. (Japan Branch), Tokyo, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Kanemoto', 'Affiliation': 'Aerie Pharmaceuticals Ireland Ltd. (Japan Branch), Tokyo, Japan.'}, {'ForeName': 'Kalyani', 'Initials': 'K', 'LastName': 'Kothapalli', 'Affiliation': 'Statistics and Data Corporation, Tempe, AZ, USA.'}, {'ForeName': 'Casey', 'Initials': 'C', 'LastName': 'Kopczynski', 'Affiliation': 'Aerie Pharmaceuticals, Inc., Irvine, CA, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Senchyna', 'Affiliation': 'Aerie Pharmaceuticals, Inc., Irvine, CA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Hollander', 'Affiliation': 'Aerie Pharmaceuticals, Inc., Irvine, CA, USA.'}]",Advances in therapy,['10.1007/s12325-021-01634-9'] 2242,33634478,Rationale and design of the OPTIMAL-REPERFUSION trial: A prospective randomized multi-center clinical trial comparing different fibrinolysis-transfer percutaneous coronary intervention strategies in acute ST-segment elevation myocardial infarction.,"Primary percutaneous coronary intervention (PPCI), the preferred reperfusion strategy for all acute ST-segment elevation myocardial infarction (STEMI) patients, is not universally available in clinical practice. Pharmacoinvasive strategy has been proposed as a therapeutic option in patients with STEMI when timely PPCI is not feasible. However, pharmacoinvasive strategy has potential delay between clinical patency and complete myocardial perfusion. The optimal reperfusion strategy for STEMI patients with anticipated PPCI delay according to current practice is uncertain. OPTIMAL-REPERFUSION is an investigator-initiated, prospective, multicenter, randomized, open-label, superiority trial with blinded evaluation of outcomes. A total of 632 STEMI patients presenting within 6 hours after symptom onset and with an expected time of first medical contact to percutaneous coronary intervention (PCI) ≥120 minute will be randomized to a reduced-dose facilitated PCI strategy (reduced-dose fibrinolysis combined with simultaneous transfer for immediate invasive therapy with a time interval between fibrinolysis to PCI < 3 hours) or to standard pharmacoinvasive treatment. The primary endpoint is the composite of death, reinfarction, refractory ischemia, congestive heart failure, or cardiogenic shock at 30-days. Enrollment of the first patient is planned in March 2021. The recruitment is anticipated to last for 12 to 18 months and to complete in September 2023 with 1 year follow-up. The OPTIMAL-REPERFUSION trial will help determine whether reduced-dose facilitated PCI strategy improves clinical outcomes in patients with STEMI and anticipated PPCI delay. This study is registered with the ClinicalTrials.gov (NCT04752345).",2021,The OPTIMAL-REPERFUSION trial will help determine whether reduced-dose facilitated PCI strategy improves clinical outcomes in patients with STEMI and anticipated PPCI delay.,"['632 STEMI patients presenting within 6 hours after symptom onset and with an expected time of first medical contact to percutaneous coronary intervention (PCI) ≥120\u2009minute', 'patients with STEMI and anticipated PPCI delay', 'acute ST-segment elevation myocardial infarction']","['fibrinolysis-transfer percutaneous coronary intervention strategies', 'Primary percutaneous coronary intervention (PPCI']","['composite of death, reinfarction, refractory ischemia, congestive heart failure, or cardiogenic shock at 30-days']","[{'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1292428', 'cui_str': '6 hours'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}]","[{'cui': 'C0016017', 'cui_str': 'Fibrinolysis'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",632.0,0.0940303,The OPTIMAL-REPERFUSION trial will help determine whether reduced-dose facilitated PCI strategy improves clinical outcomes in patients with STEMI and anticipated PPCI delay.,"[{'ForeName': 'Zhongxiu', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Duolao', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Ma', 'Affiliation': 'Department of Cardiology, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Wan', 'Affiliation': 'Department of Emergency Medicine, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Cardiology, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Mian', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Sen', 'Initials': 'S', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Department of Cardiology, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Jiafu', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'Department of Cardiology, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Baotao', 'Initials': 'B', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiology, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical cardiology,['10.1002/clc.23582'] 2243,33607831,Anesthetic effect of ultrasound-guided multiple-nerve blockade in modified radical mastectomy in patients with breast cancer.,"INTRODUCTION Routine anesthesia modality for modified radical mastectomy (MRM) includes general anesthesia (GA), epidural blockade-combined GA and nerve blockade-combined GA. However, GA has been associated with postoperative adverse effects such as vertigo, postoperative nausea and vomiting and requirement for postoperative analgesia, which hinders recovery and prognosis. Moreover, combined blockade of thoracic paravertebral nerves or intercostal nerves and adjuvant basic sedation for massive lumpectomy provided perfect anesthesia and reduced opioid consumption, whereas the excision coverage did not attain the target of MRM. Regional anesthesia strategies involving supplementation of analgesics in ultrasound-guided multiple nerve blocks have garnered interests of clinicians. Nevertheless, the precise effects of intercostal nerves, brachial plexus and supraclavicular nerves in MRM in patients with breast cancer remain obscure. METHODS Eighty female patients with breast cancer scheduled for MRM were recruited in the present trial between May, 2019 and Dec., 2019 in our hospital. The patients ranged from 30 to 65 years of age and 18∼30 kg/m2 in body-mass index, with the American Society of Anesthesiologists I or II. The patients were randomized to ultrasound-guided multiple nerve blocks group and GA group. The patients in multiple nerve blocks group underwent ultrasound guided multiple intercostal nerve blocks, interscalene brachial plexus and supraclavicular nerve blocks, (local anesthesia with 0.3% ropivacaine: 5 ml for each intercostal nerve block, 8 ml for brachial plexus block, 7 mL for supraclavicular nerve block) and basic sedation and intraoperative mask oxygen inhalation. The variations of hemodynamic parameters such as mean arterial pressure, heart rate (HR) and pulse oxygen saturation were monitored. The visual analog scale scores were recorded at postoperative 0 hour, 3 hour, 6 hour, 12 hour and 24 hour in resting state. The postoperative adverse effects, including vertigo, postoperative nausea, and vomiting, pruritus, and urinary retention and so on, as well as the analgesic consumption were recorded. CONCLUSIONS The ultrasound guided multiple intercostal nerve blocks, brachial plexus and supraclavicular nerve blocks could provide favorable anesthesia and analgesia, with noninferiority to GA and the reduced incidence of adverse effects and consumption of postoperative analgesics.",2021,"The postoperative adverse effects, including vertigo, postoperative nausea, and vomiting, pruritus, and urinary retention and so on, as well as the analgesic consumption were recorded. ","['Eighty female patients with breast cancer scheduled for MRM were recruited in the present trial between May, 2019 and Dec., 2019 in our hospital', 'patients with breast cancer remain obscure', 'patients with breast cancer', 'patients ranged from 30 to 65\u200ayears of age and 18∼30\u200akg/m2 in body-mass index, with the American Society of Anesthesiologists I or II']","['ultrasound-guided multiple nerve blocks group and GA', 'epidural blockade-combined GA and nerve blockade-combined GA', 'ultrasound guided multiple intercostal nerve blocks, interscalene brachial plexus and supraclavicular nerve blocks, (local anesthesia with 0.3% ropivacaine: 5\u200aml for each intercostal nerve block, 8\u200aml for brachial plexus block, 7\u200amL for supraclavicular nerve block) and basic sedation and intraoperative mask oxygen inhalation', 'ultrasound-guided multiple-nerve blockade', 'modified radical mastectomy (MRM']","['mean arterial pressure, heart rate (HR) and pulse oxygen saturation', 'visual analog scale scores', 'postoperative adverse effects, including vertigo, postoperative nausea, and vomiting, pruritus, and urinary retention and so on, as well as the analgesic consumption']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0196716', 'cui_str': 'Local anesthetic intercostal nerve block'}, {'cui': 'C0589495', 'cui_str': 'Interscalene approach'}, {'cui': 'C0006090', 'cui_str': 'Brachial plexus structure'}, {'cui': 'C0228833', 'cui_str': 'Supraclavicular nerves'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0394697', 'cui_str': 'Injection of anesthetic agent into brachial plexus'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0181744', 'cui_str': 'Oxygen mask'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}]","[{'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",80.0,0.0436187,"The postoperative adverse effects, including vertigo, postoperative nausea, and vomiting, pruritus, and urinary retention and so on, as well as the analgesic consumption were recorded. ","[{'ForeName': 'Haiyun', 'Initials': 'H', 'LastName': 'Du', 'Affiliation': ""Department of Anesthesiology, The Yancheng Clinical College of Xuzhou Medical University, The First People's Hospital of Yancheng, No. 166 West Yulong Road, Yancheng, P. R. China.""}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Zhouya', 'Initials': 'Z', 'LastName': 'Xue', 'Affiliation': ''}, {'ForeName': 'Yuhai', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Qian', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000024786'] 2244,33607823,"The clinical efficacy of external application of mirabilite and rhubarb combined with intrathoracic chemotherapy in treating malignant pleural effusion: A prospective, randomized, controlled clinical trial.","BACKGROUND Malignant pleural effusion (MPE) is one of the commonest causes of an exudative pleural effusion. Breathlessness, dyspnea and other symptoms often seriously distress and affect the quality of life. The external application of mirabilite and rhubarb (EAMR) combined with intrathoracic infusion of cisplatin, as an alternative treatment for MPE, is popular in China. The study aims to assess its effectiveness and safety combined with intrathoracic chemotherapy. METHODS This study is a prospective, randomized controlled clinical trial. Patient visits were performed at baseline and days 14 and 28 after treatment. Clinical outcomes were measured after chest drain placement using the criterion of efficacy refer to WHO standard, and QLQ-C30 questionnaire. RESULTS Database records of patients treated in our institution for MPE between October, 2016 and March, 2019. The study included 84 eligible patients. They were categorized with a randomization schedule into treatment group (N = 42) and control group (N = 42). There is statistical significance in the comparison of the total effective rate between these 2 groups (66.67% vs 54.76%, P < .05). Furthermore, there is statistical significance in the comparison of items of Physical (1.95 ± 0.50 vs 2.19 ± 0.58%, P < .05), Pain (1.98 ± 0.42 vs 2.07 ± 0.32, P < .05), and Global Health (1.23 ± 0.64 vs 1.13 ± 0.23%, P < .05) between these 2 groups. None of the patients had adverse reactions such as skin allergy and chest tightness. CONCLUSIONS The total effective rate of treatment group using extra external application of mirabilite rhubarb powder is significantly higher than that of control group. The improvement of patients' clinical symptoms is greater in treatment group and no adverse reactions is found. Therefore, external application of mirabilite and rhubarb combined with intrathoracic infusion of cisplatin is an effective method for the treatment of MPE, which is worth popularizing.",2021,"There is statistical significance in the comparison of the total effective rate between these 2 groups (66.67% vs 54.76%, P < .05).","['84 eligible patients', 'treating malignant pleural effusion']","['cisplatin', 'mirabilite and rhubarb combined with intrathoracic chemotherapy', 'intrathoracic chemotherapy', 'mirabilite and rhubarb (EAMR) combined with intrathoracic infusion of cisplatin']","['total effective rate', 'adverse reactions such as skin allergy and chest tightness', 'efficacy refer to WHO standard, and QLQ-C30 questionnaire', 'Pain', 'quality of life', 'Global Health', ""patients' clinical symptoms"", 'Breathlessness, dyspnea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0080032', 'cui_str': 'Neoplastic pleural effusion'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0035509', 'cui_str': 'Rhubarb'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0595836', 'cui_str': 'Intrathoracic route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0585186', 'cui_str': 'Cutaneous hypersensitivity'}, {'cui': 'C0232292', 'cui_str': 'Tight chest'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}]",84.0,0.0628036,"There is statistical significance in the comparison of the total effective rate between these 2 groups (66.67% vs 54.76%, P < .05).","[{'ForeName': 'Huachun', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, LongHua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Mengyuan', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': ''}, {'ForeName': 'Lirong', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': ''}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Lin', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000024758'] 2245,33607813,Ketorolac plus Lidocaine vs Lidocaine for pain relief following core needle soft tissue biopsy: A CONSORT-compliant double-blind randomized controlled study.,"BACKGROUNDS The main objective of this study was to compare the pain control efficacy of local administration of Lidocaine with or without the nonsteroidal anti-inflammatory drug, Ketorolac, and local conventional Lidocaine injection in core needle biopsy of the musculoskeletal tumor. METHODS The current study was a randomized, double-blind controlled clinical trial that included 128 patients with suspected musculoskeletal tumors. Patients were randomly assigned to either the Ketorolac plus Lidocaine (n = 64) or Lidocaine group (n = 64). The Ketorolac - Lidocaine combination syringe contained 30 mg Ketorolac and 2% Lidocaine - adrenaline dosage, and the Lidocaine syringe contained 2% Lidocaine - adrenaline dosage. The level of pain after core needle biopsy was evaluated for each patient at 1, 6, 12, 24, 48, and >48 hours by a Visual Analog Scale (VAS). The mean VAS changes over time were compared between the Ketorolac plus Lidocaine and Lidocaine groups using a linear mixed model. RESULTS baseline information including mean age of patients in Lidocaine group (51.5 ± 19.4 years) and in Lidocaine - Ketorolac combination group (50.1 ± 18 years), diagnosis (malignant, benign, metastatic, infection), tumor location (upper and lower extremities, back), VAS score 1-hour post-operation (mild and moderate pain) were noted. The VAS score ratings were significantly lower in Lidocaine - Ketorolac combination group when compared to the Lidocaine group during the 1 to 24 hours post-operation time period. CONCLUSION Patients receiving Lidocaine - Ketorolac combination dosage had significantly lower VAS scores, and these results confirm that local injection of Lidocaine - Ketorolac combination had a superior pain-controlling effect during the first 24 hours after the biopsy procedure in comparison to Lidocaine injection alone, as measured by VAS score scale.",2021,"The VAS score ratings were significantly lower in Lidocaine - Ketorolac combination group when compared to the Lidocaine group during the 1 to 24 hours post-operation time period. ","['pain relief following core needle soft tissue biopsy', '128 patients with suspected musculoskeletal tumors']","['Lidocaine - Ketorolac', 'Lidocaine - adrenaline', 'Ketorolac plus Lidocaine', 'Ketorolac - Lidocaine', 'Lidocaine syringe', 'Ketorolac and 2% Lidocaine - adrenaline', 'Lidocaine', 'nonsteroidal anti-inflammatory drug, Ketorolac, and local conventional Lidocaine injection']","['VAS score ratings', 'level of pain', 'VAS score scale', 'pain control efficacy', 'diagnosis (malignant, benign, metastatic, infection), tumor location (upper and lower extremities, back), VAS score 1-hour post-operation (mild and moderate pain', 'superior pain-controlling effect', 'Visual Analog Scale (VAS', 'VAS scores', 'mean VAS changes']","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0185275', 'cui_str': 'Biopsy of soft tissue'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C4049857', 'cui_str': 'Lidocaine Injection'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0278139', 'cui_str': 'Moderate pain'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",128.0,0.120413,"The VAS score ratings were significantly lower in Lidocaine - Ketorolac combination group when compared to the Lidocaine group during the 1 to 24 hours post-operation time period. ","[{'ForeName': 'Thanapon', 'Initials': 'T', 'LastName': 'Chobpenthai', 'Affiliation': 'Faculty of Medicine and Public Health, HRH Princess Chulabhorn College of Medical Science, Chulabhorn Royal Academy.'}, {'ForeName': 'Thammasin', 'Initials': 'T', 'LastName': 'Ingviya', 'Affiliation': 'Department of Family and Preventive Medicine.'}, {'ForeName': 'Pichaya', 'Initials': 'P', 'LastName': 'Thanindratarn', 'Affiliation': 'Department of Orthopedics, Chulabhorn Hospital, Bangkok.'}, {'ForeName': 'Rattakorn', 'Initials': 'R', 'LastName': 'Jaiwithee', 'Affiliation': 'Department of Orthopedics, Chulabhorn Hospital, Bangkok.'}, {'ForeName': 'Kulwadee', 'Initials': 'K', 'LastName': 'Sutthivaiyakit', 'Affiliation': 'Department of Anesthesiology Unit, Chulabhorn Hospital, Bangkok, Thailand.'}]",Medicine,['10.1097/MD.0000000000024721'] 2246,33607806,Comparison of airway management without neuromuscular blockers in laparoscopic gynecological surgery.,"ABSTRACT New generation supraglottic airway devices are suitable for airway management in many laparoscopic surgeries. In this study, we evaluated and compared the ventilation parameters of the laryngeal mask airway-supreme (LM-S) and endotracheal tube (ETT) when a neuromuscular blocker (NMB) agent was not used during laparoscopic gynecological surgery. The second outcome was based on the evaluation of the surgical view because it may affect the surgical procedure.This was a randomized study that enrolled 100 patients between 18 and 65 years old with an ASA I-II classification. Patients were divided into 2 groups: Group ETT and Group LM-S. Standard anesthesia and ventilation protocols were administered to patients in each group. Ventilation parameters [airway peak pressure (Ppeak), mean airway pressure (Pmean), total volume, and oropharyngeal leak pressure] were recorded before, after, and during peritoneal insufflation and before desufflation, as well as after the removal of the airway device. Perioperative surgical view quality and the adequacy of the pneumoperitoneum were also recorded.The data of 100 patients were included in the statistical analysis. The Ppeak values in Group ETT were significantly higher in the second minute after airway device insertion. The Ppeak and Pmean values in Group ETT were significantly higher before desufflation and after removal of the airway device. No significant differences were found between the groups in terms of adequacy of the pneumoperitoneum or quality of the surgical view.The results of this study showed that gynecological laparoscopies can be performed without using a NMB. Satisfactory conditions for ventilation and surgery can be achieved while sparing the use of muscle relaxants in both groups despite the Trendelenburg position and the pneumoperitoneum of the patients, which are typical for laparoscopic gynecological surgery. The results are of clinical significance because they show that the use of a muscle relaxant is unnecessary when supraglottic airways are used for these surgical procedures.",2021,No significant differences were found between the groups in terms of adequacy of the pneumoperitoneum or quality of the surgical view.,"['100 patients were included in the statistical analysis', 'laparoscopic gynecological surgery', 'enrolled 100 patients between 18 and 65\u200ayears old with an ASA I-II classification']","['neuromuscular blocker (NMB', 'airway management without neuromuscular blockers', 'laryngeal mask airway-supreme (LM-S) and endotracheal tube (ETT', 'Group ETT and Group LM-S. Standard anesthesia and ventilation protocols']","['Ventilation parameters [airway peak pressure (Ppeak), mean airway pressure (Pmean), total volume, and oropharyngeal leak pressure', 'adequacy of the pneumoperitoneum or quality of the surgical view']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]","[{'cui': 'C0027866', 'cui_str': 'Neuromuscular blocking agent'}, {'cui': 'C0150126', 'cui_str': 'Airway management'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C3282376', 'cui_str': 'Supreme'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3267120', 'cui_str': 'Airway peak pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0449911', 'cui_str': 'View'}]",100.0,0.0212584,No significant differences were found between the groups in terms of adequacy of the pneumoperitoneum or quality of the surgical view.,"[{'ForeName': 'Sule', 'Initials': 'S', 'LastName': 'Ozbilgin', 'Affiliation': 'Department of Anesthesiology and Intensive Care.'}, {'ForeName': 'Bahar', 'Initials': 'B', 'LastName': 'Kuvaki', 'Affiliation': 'Department of Anesthesiology and Intensive Care.'}, {'ForeName': 'Hatice Keskin', 'Initials': 'HK', 'LastName': 'Şimşek', 'Affiliation': 'Department of Public Health.'}, {'ForeName': 'Bahadir', 'Initials': 'B', 'LastName': 'Saatli', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Dokuz Eylul University, Izmir, Turkey.'}]",Medicine,['10.1097/MD.0000000000024676'] 2247,33601033,"Letter to the editor on ""Efficacy and safety of favipiravir, an oral RNA-dependent RNA polymerase inhibitor, in mild-to-moderate COVID-19: A randomized, comparative, open-label, multicenter, phase 3 clinical trial"" by Udwadia et al.",,2021,,[],"['Favipiravir, an Oral RNA-Dependent RNA Polymerase Inhibitor']",[],[],"[{'cui': 'C1138226', 'cui_str': 'favipiravir'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0035685', 'cui_str': 'RNA-directed RNA polymerase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]",[],,0.0324477,,"[{'ForeName': 'Mahender Kumar', 'Initials': 'MK', 'LastName': 'Medisetty', 'Affiliation': 'Apollo Institute of Medical Science and Research, Apollo Health Campus, Hyderabad, India. Electronic address: mahenderkumar.dr@gmail.com.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Department of Infectious Disease, Sterling Hospital, Ahmedabad, India. Electronic address: atulpatel65@gmail.com.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Pujari', 'Affiliation': 'Institute of Infectious Disease, Pune, India. Electronic address: sanjaypujari@gmail.com.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2021.02.035'] 2248,33610734,FAST: a randomised phase II study of zolbetuximab (IMAB362) plus EOX versus EOX alone for first-line treatment of advanced CLDN18.2-positive gastric and gastro-oesophageal adenocarcinoma.,"BACKGROUND Claudin 18.2 (CLDN18.2) is contained within normal gastric mucosa epithelial tight junctions; upon malignant transformation, CLDN18.2 epitopes become exposed. Zolbetuximab, a chimeric monoclonal antibody, mediates specific killing of CLDN18.2-positive cells through immune effector mechanisms. PATIENTS AND METHODS The FAST study enrolled advanced gastric/gastro-oesophageal junction and oesophageal adenocarcinoma patients (aged ≥18 years) with moderate-to-strong CLDN18.2 expression in ≥40% tumour cells. Patients received first-line epirubicin + oxaliplatin + capecitabine (EOX, arm 1, n = 84) every 3 weeks (Q3W), or zolbetuximab + EOX (loading dose, 800 mg/m 2 then 600 mg/m 2 Q3W) (arm 2, n = 77). Arm 3 (exploratory) was added after enrolment initiation (zolbetuximab + EOX 1000 mg/m 2 Q3W, n = 85). The primary endpoint was progression-free survival (PFS) and overall survival (OS) was a secondary endpoint. RESULTS In the overall population, both PFS [hazard ratio (HR) = 0.44; 95% confidence interval (CI), 0.29-0.67; P < 0.0005] and OS (HR = 0.55; 95% CI, 0.39-0.77; P < 0.0005) were significantly improved with zolbetuximab + EOX (arm 2) compared with EOX alone (arm 1). This significant PFS benefit was retained in patients with moderate-to-strong CLDN18.2 expression in ≥70% of tumour cells (HR = 0.38; 95% CI, 0.23-0.62; P < 0.0005). Significant improvement in PFS was also reported in the overall population of arm 3 versus arm 1 (HR = 0.58; 95% CI, 0.39-0.85; P = 0.0114) but not in high CLDN18.2-expressing patients; no significant improvement in OS was observed in either population. Most adverse events (AEs) related to zolbetuximab + EOX (nausea, vomiting, neutropenia, anaemia) were grade 1-2. Grade ≥3 AEs showed no substantial increases overall (zolbetuximab + EOX versus EOX alone). CONCLUSIONS In advanced gastric/gastro-oesophageal junction and oesophageal adenocarcinoma patients expressing CLDN18.2, adding zolbetuximab to first-line EOX provided longer PFS and OS versus EOX alone. Zolbetuximab + EOX was generally tolerated and AEs were manageable. Zolbetuximab 800/600 mg/m 2 is being evaluated in phase III studies based on clinical benefit observed in the overall population and in patients with moderate-to-strong CLDN18.2 expression in ≥70% of tumour cells.",2021,"In the overall population, both PFS (HR=0.44; 95% CI, 0.29-0.67; P<0.0005) and OS (HR=0.55; 95% CI, 0.39-0.77; P<0.0005) were significantly improved with zolbetuximab+EOX (Arm 2) compared with EOX alone (Arm 1).","['The FAST study enrolled advanced gastric/gastro-oesophageal junction (G/GEJ) and oesophageal adenocarcinoma (EC) patients (≥18 years) with moderate-to-strong CLDN18.2 expression in ≥40% tumour cells', 'advanced CLDN18.2 positive gastric and gastro-oesophageal adenocarcinoma']","['first-line epirubicin+oxaliplatin+capecitabine (EOX, Arm 1, n=84) every 3 weeks (Q3W), or zolbetuximab+EOX (loading dose, 800 mg/m 2 then 600 mg/m 2 Q3W', 'Zolbetuximab', 'Zolbetuximab+EOX', 'zolbetuximab+EOX', 'FAST', 'zolbetuximab (IMAB362) plus EOX vs EOX']","['PFS', 'PFS benefit', 'OS', 'progression-free survival (PFS) and overall survival (OS', 'zolbetuximab+EOX (nausea, vomiting, neutropaenia, anaemia']","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0014871', 'cui_str': 'Cardioesophageal junction structure'}, {'cui': 'C0279628', 'cui_str': 'Adenocarcinoma of esophagus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]","[{'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C2827697', 'cui_str': 'claudiximab'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",,0.0963059,"In the overall population, both PFS (HR=0.44; 95% CI, 0.29-0.67; P<0.0005) and OS (HR=0.55; 95% CI, 0.39-0.77; P<0.0005) were significantly improved with zolbetuximab+EOX (Arm 2) compared with EOX alone (Arm 1).","[{'ForeName': 'U', 'Initials': 'U', 'LastName': 'Sahin', 'Affiliation': 'Department of Experimental and Translational Oncology, TRON - Translational Oncology at the University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany; Department of Oncology, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany; Biopharmaceutical New Technologies (BioNTech) Corporation, Mainz, Germany.'}, {'ForeName': 'Ö', 'Initials': 'Ö', 'LastName': 'Türeci', 'Affiliation': 'Biopharmaceutical New Technologies (BioNTech) Corporation, Mainz, Germany; CI3 - Cluster of Individualized Immune Intervention, Mainz, Germany; formerly of Ganymed Pharmaceuticals GmbH.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Manikhas', 'Affiliation': 'Department of Oncology, City Clinical Oncology Center, St. Petersburg, Russia.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Lordick', 'Affiliation': 'Department of Medicine II and University Cancer Center Leipzig, University of Leipzig Medical Center, Leipzig, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rusyn', 'Affiliation': 'Department of Oncology, Transcarpathian Regional Clinical Oncological Center, Uzhhorod, Ukraine.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Vynnychenko', 'Affiliation': 'Sumy State University, Sumy Regional Clinical Oncology Center, Oncothoracic Department, Sumy, Ukraine.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dudov', 'Affiliation': 'Department of Oncology, Acibadem City Clinic Mladost, Sofia, Bulgaria.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Bazin', 'Affiliation': 'Department of Clinical Pharmacology and Chemotherapy, Russian Oncology Research Center n. a. N.N. Blokhin, Moscow, Russia.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Bondarenko', 'Affiliation': 'Dnipropetrovsk Medical Academy, City Multispecialty Clinical Hospital #4, Department of Chemotherapy, Dnipropetrovsk, Ukraine.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Melichar', 'Affiliation': 'Department of Oncology, Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Dhaene', 'Affiliation': 'MD Dhaene Pathology Lab BVBA, Destelbergen, Belgium.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Wiechen', 'Affiliation': 'Department of Pathology, Klinikum Worms GmbH, Institute for Pathology, Worms, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Huber', 'Affiliation': 'Department of Experimental and Translational Oncology, TRON - Translational Oncology at the University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany; Biopharmaceutical New Technologies (BioNTech) Corporation, Mainz, Germany; CI3 - Cluster of Individualized Immune Intervention, Mainz, Germany; formerly of Ganymed Pharmaceuticals GmbH.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Maurus', 'Affiliation': 'Formerly of Ganymed Pharmaceuticals GmbH, Mainz, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Arozullah', 'Affiliation': 'Astellas Pharma Global Development, Inc., Northbrook, USA.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'Astellas Pharma Global Development, Inc., Northbrook, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schuler', 'Affiliation': 'West German Cancer Center, University Duisburg-Essen, and German Cancer Consortium (DKTK), Partner Site University Hospital Essen, Essen, Germany.'}, {'ForeName': 'S-E', 'Initials': 'SE', 'LastName': 'Al-Batran', 'Affiliation': 'Institute of Clinical Cancer Research (IKF) at Krankenhaus Nordwest, Frankfurt, Germany. Electronic address: albatran.salah@khnw.de.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2021.02.005'] 2249,33610726,Effect of French maritime pine bark extract supplementation on metabolic status and serum vascular cell adhesion molecule-1 levels in patients with type 2 diabetes and microalbuminuria.,"OBJECTIVES This study investigated the effect of French maritime pine bark extract (PBE) supplementation on metabolic parameters, vascular cell adhesion molecule 1 (VCAM-1), urinary albumin-to-creatinine ratio (UACR), and anthropometric indexes in patients with type 2 diabetes (T2DM) and microalbuminuria. DESIGN This randomized, double-blind, placebo-controlled clinical trial was conducted on 46 patients with T2DM and the evidence of microalbuminuria aged 30-65 years. SETTING Patients were recruited from the endocrinology clinic of Sina hospital (Tabriz, Iran) from March 2018 to April 2019. INTERVENTIONS The subjects were randomly assigned to receive two capsules/day each containing 50mg of PBE or placebo for eight weeks. MAIN OUTCOME MEASURES Glycemic parameters, serum VCAM-1 and lipid profile, UACR, and anthropometric indexes were measured for all patients at baseline and the end of the study. RESULTS PBE supplementation significantly reduced glycosylated hemoglobin, VCAM-1, total cholesterol, UACR, waist circumference, and waist-to-height ratio compared to the placebo group at the end of the study (all P < 0.05). Changes in fasting blood glucose, insulin, triglyceride, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol were not significant between the two groups (all P > 0.05). CONCLUSIONS The study findings demonstrated some favorable effects of PBE supplementation on glycemic control, serum VCAM-1 and total cholesterol levels, and microalbuminuria, as well as abdominal obesity in patients with T2DM.",2021,"RESULTS PBE supplementation significantly reduced glycosylated hemoglobin, VCAM-1, total cholesterol, UACR, waist circumference, and waist-to-height ratio compared to the placebo group at the end of the study (all P < 0.05).","['patients with T2DM', 'Patients were recruited from the endocrinology clinic of Sina hospital (Tabriz, Iran) from March 2018 to April 2019', 'patients with type 2 diabetes (T2DM) and microalbuminuria', 'patients with type 2 diabetes and microalbuminuria', '46 patients with T2DM and the evidence of microalbuminuria aged 30 to 65 years']","['placebo', 'PBE supplementation', 'PBE or placebo', 'French maritime pine bark extract supplementation', 'French maritime pine bark extract (PBE) supplementation']","['fasting blood glucose, insulin, triglyceride, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol', 'Glycemic parameters, serum VCAM-1 and lipid profile, UACR, and anthropometric indexes', 'metabolic status and serum vascular cell adhesion molecule-1 levels', 'glycemic control, serum VCAM-1 and total cholesterol levels, and microalbuminuria, as well as abdominal obesity', 'metabolic parameters, vascular cell adhesion molecule 1 (VCAM-1), urinary albumin-to-creatinine ratio (UACR), and anthropometric indexes', 'glycosylated hemoglobin, VCAM-1, total cholesterol, UACR, waist circumference, and waist-to-height ratio']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3810855', 'cui_str': 'Endocrinology clinic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0872909', 'cui_str': 'pine bark extract'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4283948', 'cui_str': 'French maritime pine bark extract'}]","[{'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C1821269', 'cui_str': 'Waist to Height Ratio'}]",46.0,0.220432,"RESULTS PBE supplementation significantly reduced glycosylated hemoglobin, VCAM-1, total cholesterol, UACR, waist circumference, and waist-to-height ratio compared to the placebo group at the end of the study (all P < 0.05).","[{'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Navval-Esfahlan', 'Affiliation': ""Students' Research Committee, Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Tabriz, Iran.""}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Rafraf', 'Affiliation': 'Nutrition Research Center, Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: rafrafm@tbzmed.ac.ir.'}, {'ForeName': 'Somayyeh', 'Initials': 'S', 'LastName': 'Asghari', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Imani', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Asghari-Jafarabadi', 'Affiliation': 'Road Traffic Injury Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Karimi-Avval', 'Affiliation': 'Department of Endocrine and Metabolism, Sina Medical Research and Training Hospital, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2021.102689'] 2250,33611761,MMSE is an independent prognostic factor for survival in primary central nervous system lymphoma.,"INTRODUCTION To assess the value of the Mini-Mental State Examination (MMSE)-score at baseline in predicting survival in adult primary central nervous system lymphoma (PCNSL) patients. METHODS In the HOVON 105/ ALLG NHL 24 phase III study patients with newly-diagnosed PCNSL were randomized between high-dose methotrexate-based chemotherapy with or without rituximab. Data on potential (MMSE-score), and known baseline prognostic factors (age, performance status, serum LDH, cerebrospinal fluid total protein, involvement of deep brain structures, multiple cerebral lesions, and the IELSG-score) were collected prospectively. Multivariable stepwise Cox regression analyses were used to assess the prognostic value of all factors on progression-free survival (PFS) and overall survival (OS) among patients with available MMSE score at baseline. Age was analyzed as continuous variable, the MMSE-score both as a continuous and as a categorical variable. RESULTS In univariable analysis, age, MMSE-score and whether the patient received rituximab were statistically significantly prognostic factors for PFS. Age and MMSE-score were statistically significantly associated with OS. In a multivariable analysis of the univariately significant factors only MMSE-score was independently associated with the survival endpoints, as a continuous variable (HR for PFS 1.04, 95% CI 1.01-1.08; OS 1.06 (95% CI 1.02-1.10) and as categorical variable HR (< 27 versus ≥ 27 for PFS 1.55 (1.02-2.35); OS 1.68 (1.05-2.70). In our population, performance status, serum LDH, and CSF protein level were not of prognostic value. CONCLUSION Neurocognitive disturbances, measured with the MMSE at baseline, are an unfavorable prognostic factor for both PFS and OS in adult PCNSL patients up to 70 years-old.",2021,"In univariable analysis, age, MMSE-score and whether the patient received rituximab were statistically significantly prognostic factors for PFS.","['patients with newly-diagnosed PCNSL', 'adult primary central nervous system lymphoma (PCNSL) patients']","['Mini-Mental State Examination (MMSE)-score at baseline', 'MMSE', 'methotrexate-based chemotherapy with or without rituximab']","['performance status, serum LDH, and CSF protein level', 'survival endpoints', 'potential (MMSE-score), and known baseline prognostic factors (age, performance status, serum LDH, cerebrospinal fluid total protein, involvement of deep brain structures, multiple cerebral lesions, and the IELSG-score', 'categorical variable HR', 'progression-free survival (PFS) and overall survival (OS', 'Age and MMSE-score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0280803', 'cui_str': 'Primary central nervous system lymphoma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1278052', 'cui_str': 'Serum lactate dehydrogenase measurement'}, {'cui': 'C0201943', 'cui_str': 'Measurement of protein in cerebrospinal fluid specimen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1514474', 'cui_str': 'Prognostic Factors'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0221505', 'cui_str': 'Lesion of brain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.236234,"In univariable analysis, age, MMSE-score and whether the patient received rituximab were statistically significantly prognostic factors for PFS.","[{'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'van der Meulen', 'Affiliation': 'Department of Neuro-Oncology, Erasmus MC Cancer Institute, Brain Tumor Center, University Medical Center Rotterdam, Dr. Molewaterplein 40, 3015 GD, Rotterdam, Netherlands. m.vandermeulen.2@erasmusmc.nl.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Dirven', 'Affiliation': 'Department of Neurology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Bakunina', 'Affiliation': 'Department of Hematology, HOVON Data Center, Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'van den Bent', 'Affiliation': 'Department of Neuro-Oncology, Erasmus MC Cancer Institute, Brain Tumor Center, University Medical Center Rotterdam, Dr. Molewaterplein 40, 3015 GD, Rotterdam, Netherlands.'}, {'ForeName': 'Samar', 'Initials': 'S', 'LastName': 'Issa', 'Affiliation': 'Department of Hematology, Middlemore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Jeanette K', 'Initials': 'JK', 'LastName': 'Doorduijn', 'Affiliation': 'Department of Hematology, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Jacoline E C', 'Initials': 'JEC', 'LastName': 'Bromberg', 'Affiliation': 'Department of Neuro-Oncology, Erasmus MC Cancer Institute, Brain Tumor Center, University Medical Center Rotterdam, Dr. Molewaterplein 40, 3015 GD, Rotterdam, Netherlands.'}]",Journal of neuro-oncology,['10.1007/s11060-021-03708-8'] 2251,33611742,Beneficial Effects of Intravenous Magnesium Administration During Robotic Radical Prostatectomy: A Randomized Controlled Trial.,"INTRODUCTION Robotic radical prostatectomy requires prolonged pneumoperitoneum and a steep Trendelenburg position. Magnesium can attenuate the stress response and hemodynamic perturbations. This study aimed to evaluate the effects of intravenous magnesium administration on hemodynamics and the stress response in patients undergoing robotic radical prostatectomy. METHODS In this prospective, double-blind, randomized controlled study, 52 patients undergoing robotic radical prostatectomy were randomized into two groups: 26 in the magnesium group and 26 in the control group. The patients in the magnesium group received magnesium sulfate 50 mg/kg intravenously, followed by infusion at a rate of 10 mg/kg/h during surgery. The patients in the control group received an equal volume of 0.9% saline. The primary outcomes were the changes in heart rate and mean arterial pressure (MAP) during surgery. The serum stress hormones (adrenocorticotropic hormone, cortisol, epinephrine, and norepinephrine) were also measured. RESULTS MAP showed a significant intergroup difference over time (P group*time  = 0.017); it increased significantly at 5 min after Trendelenburg position in the control group and decreased significantly at 30 min after Trendelenburg position in the magnesium group. The intergroup difference in the change in cortisol concentrations was significant over time (P group*time  = 0.006). The cortisol concentration decreased significantly from baseline to 24 h after surgery in the magnesium group but did not change significantly in the control group. The requirement for intraoperative remifentanil was 35% lower in the magnesium group (P = 0.011), and the severity of postoperative pain at 30 min and 6 h after surgery was also lower in the magnesium group (P = 0.024 and P = 0.015). CONCLUSION There is a possibility that intravenous magnesium administration during robotic radical prostatectomy reduces the increases in arterial pressure, cortisol concentrations, opioid requirements, and postoperative pain. TRIAL REGISTRATION ClinicalTrials.gov identifier, NCT02833038.",2021,"The requirement for intraoperative remifentanil was 35% lower in the magnesium group (P = 0.011), and the severity of postoperative pain at 30 min and 6 h after surgery was also lower in the magnesium group (P = 0.024 and P = 0.015). ","['52 patients undergoing robotic radical prostatectomy', 'patients undergoing robotic radical prostatectomy', 'Robotic Radical Prostatectomy']","['Robotic radical prostatectomy', 'magnesium sulfate', 'Magnesium', 'magnesium', 'equal volume of 0.9% saline', 'Intravenous Magnesium']","['serum stress hormones (adrenocorticotropic hormone, cortisol, epinephrine, and norepinephrine', 'stress response and hemodynamic perturbations', 'severity of postoperative pain', 'change in cortisol concentrations', 'arterial pressure, cortisol concentrations, opioid requirements, and postoperative pain', 'requirement for intraoperative remifentanil', 'changes in heart rate and mean arterial pressure (MAP', 'cortisol concentration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0232108', 'cui_str': 'Arterial pulse pressure'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",52.0,0.287592,"The requirement for intraoperative remifentanil was 35% lower in the magnesium group (P = 0.011), and the severity of postoperative pain at 30 min and 6 h after surgery was also lower in the magnesium group (P = 0.024 and P = 0.015). ","[{'ForeName': 'Ha Yeon', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, South Korea.'}, {'ForeName': 'Sook Young', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, South Korea.'}, {'ForeName': 'Hye Sun', 'Initials': 'HS', 'LastName': 'Lee', 'Affiliation': 'Biostatistics Collaboration Unit, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Bo Kyeong', 'Initials': 'BK', 'LastName': 'Jun', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, South Korea.'}, {'ForeName': 'Jong Bum', 'Initials': 'JB', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, South Korea.'}, {'ForeName': 'Ji Eun', 'Initials': 'JE', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, South Korea. beye98@aumc.ac.kr.'}]",Advances in therapy,['10.1007/s12325-021-01643-8'] 2252,33619370,Development of a human skin commensal microbe for bacteriotherapy of atopic dermatitis and use in a phase 1 randomized clinical trial.,"Staphylococcus aureus colonizes patients with atopic dermatitis (AD) and exacerbates disease by promoting inflammation. The present study investigated the safety and mechanisms of action of Staphylococcus hominis A9 (ShA9), a bacterium isolated from healthy human skin, as a topical therapy for AD. ShA9 killed S. aureus on the skin of mice and inhibited expression of a toxin from S. aureus (psmα) that promotes inflammation. A first-in-human, phase 1, double-blinded, randomized 1-week trial of topical ShA9 or vehicle on the forearm skin of 54 adults with S. aureus-positive AD (NCT03151148) met its primary endpoint of safety, and participants receiving ShA9 had fewer adverse events associated with AD. Eczema severity was not significantly different when evaluated in all participants treated with ShA9 but a significant decrease in S. aureus and increased ShA9 DNA were seen and met secondary endpoints. Some S. aureus strains on participants were not directly killed by ShA9, but expression of mRNA for psmα was inhibited in all strains. Improvement in local eczema severity was suggested by post-hoc analysis of participants with S. aureus directly killed by ShA9. These observations demonstrate the safety and potential benefits of bacteriotherapy for AD.",2021,Eczema severity was not significantly different when evaluated in all participants treated with ShA9 but a significant decrease in S. aureus and increased ShA9 DNA were seen and met secondary endpoints.,"['54 adults with S. aureus-positive AD', 'Staphylococcus aureus colonizes patients with atopic dermatitis (AD', 'healthy human skin']","['bacteriotherapy', 'topical ShA9', 'Staphylococcus hominis A9 (ShA9']","['Eczema severity', 'S. aureus and increased ShA9 DNA', 'local eczema severity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3859811', 'cui_str': 'human skin preparation'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0318113', 'cui_str': 'Staphylococcus hominis'}]","[{'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0318113', 'cui_str': 'Staphylococcus hominis'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0205276', 'cui_str': 'Local'}]",54.0,0.40691,Eczema severity was not significantly different when evaluated in all participants treated with ShA9 but a significant decrease in S. aureus and increased ShA9 DNA were seen and met secondary endpoints.,"[{'ForeName': 'Teruaki', 'Initials': 'T', 'LastName': 'Nakatsuji', 'Affiliation': 'Department of Dermatology, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Tissa R', 'Initials': 'TR', 'LastName': 'Hata', 'Affiliation': 'Department of Dermatology, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Tong', 'Affiliation': 'Department of Dermatology, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Joyce Y', 'Initials': 'JY', 'LastName': 'Cheng', 'Affiliation': 'Department of Dermatology, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Faiza', 'Initials': 'F', 'LastName': 'Shafiq', 'Affiliation': 'Department of Dermatology, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Butcher', 'Affiliation': 'Department of Dermatology, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Secilia S', 'Initials': 'SS', 'LastName': 'Salem', 'Affiliation': 'Department of Dermatology, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Brinton', 'Affiliation': 'Department of Dermatology, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Amanda K', 'Initials': 'AK', 'LastName': 'Rudman Spergel', 'Affiliation': 'Division of Allergy, Immunology and Transplantation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Keli', 'Initials': 'K', 'LastName': 'Johnson', 'Affiliation': 'Rho Federal Systems Division, Inc., Durham, NC, USA.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Jepson', 'Affiliation': 'Rho Federal Systems Division, Inc., Durham, NC, USA.'}, {'ForeName': 'Agustin', 'Initials': 'A', 'LastName': 'Calatroni', 'Affiliation': 'Rho Federal Systems Division, Inc., Durham, NC, USA.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'David', 'Affiliation': 'Rho Federal Systems Division, Inc., Durham, NC, USA.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Ramirez-Gama', 'Affiliation': 'Division of Allergy and Immunology, Department of Pediatrics, National Jewish Health, Denver, CO, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Taylor', 'Affiliation': 'Division of Allergy and Immunology, Department of Pediatrics, National Jewish Health, Denver, CO, USA.'}, {'ForeName': 'Donald Y M', 'Initials': 'DYM', 'LastName': 'Leung', 'Affiliation': 'Division of Allergy and Immunology, Department of Pediatrics, National Jewish Health, Denver, CO, USA.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Gallo', 'Affiliation': 'Department of Dermatology, University of California, San Diego, La Jolla, CA, USA. rgallo@health.ucsd.edu.'}]",Nature medicine,['10.1038/s41591-021-01256-2'] 2253,33617696,Direct-access physiotherapy to help manage patients with musculoskeletal disorders in an emergency department: Results of a randomized controlled trial.,"OBJECTIVES The objective was to evaluate the effects of direct-access physiotherapy on patients presenting with a musculoskeletal disorder (MSKD) to the emergency department (ED) on clinical outcomes and use of health care resources. METHODS We conducted a randomized controlled trial in an academic ED in Québec City, Canada. We included patients aged 18 to 80 years with minor MSKD. The intervention group had direct access to a physiotherapist (PT) in the ED immediately after triage and prior to physician assessment, and the control group received usual care by the emergency physician without PT intervention. The key variables included clinical outcomes (pain, interference of pain on function) and resources use (ED return visit, medications, diagnostic tests, additional consultations). They were analyzed using descriptive statistics and compared between groups using two-way analyses of variance, log-linear analysis, and chi-square tests. RESULTS Seventy-eight patients suffering from MSKDs were included (40.2 ± 17.6 years old; 44% women). For the primary clinical outcome, participants in the PT group (n = 40) had statistically lower levels of pain and pain interference at 1 and 3 months. In terms of resource use, participants in the PT group returned significantly less often to the ED. At baseline and 1 month, less prescription medication was used, including opioids, but there were no differences at 3 months. Although over-the-counter medication was recommended more at baseline in the PT group, there were no differences in use at 1 month, and the PT group had used them less at 3 months. There were no differences between groups at follow-up for imaging tests, other professionals consulted, and hospitalization rates. CONCLUSION Patients presenting with a MSKD to the ED with direct access to a PT had better clinical outcomes and used less services and resources than those in the usual care group after ED discharge and up to 3 months after discharge.",2021,"At baseline and 1 month, less prescription medication was used, including opioids, but there were no differences at 3 months.","['patients presenting with a musculoskeletal disorder (MSKD) to the emergency department (ED', 'Seventy-eight patients suffering from MSKDs were included (40.2 ± 17.6 years old; 44% women', 'patients with musculoskeletal disorders in an emergency department', 'academic ED in Québec City, Canada', 'patients aged 18-80 years with minor MSKD']","['direct access physiotherapy', 'control group received usual care by the emergency physician without PT intervention', 'direct access to a physiotherapist (PT', 'Direct access physiotherapy']","['hospitalization rates', 'clinical outcomes (pain, interference of pain on function) and resources use (ED return visit, medications, diagnostic tests, additional consultations', 'prescription medication', 'pain and pain interference']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0026857', 'cui_str': 'Disorder of musculoskeletal system'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0026193', 'cui_str': 'Minor'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0430022', 'cui_str': 'Diagnostic procedure'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}]",78.0,0.0612577,"At baseline and 1 month, less prescription medication was used, including opioids, but there were no differences at 3 months.","[{'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Gagnon', 'Affiliation': 'Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS), Quebec, Quebec, Canada.'}, {'ForeName': 'Kadija', 'Initials': 'K', 'LastName': 'Perreault', 'Affiliation': 'Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS), Quebec, Quebec, Canada.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Berthelot', 'Affiliation': 'Departments of Rehabilitation, Medicine and Radiology and Nuclear Medicine, Faculty of Medicine, Université Laval, Quebec, Quebec, Canada.'}, {'ForeName': 'Eveline', 'Initials': 'E', 'LastName': 'Matifat', 'Affiliation': 'Faculté de Médecine, École de Réhabilitation, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Desmeules', 'Affiliation': 'Faculté de Médecine, École de Réhabilitation, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Achou', 'Affiliation': 'HEC Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Laroche', 'Affiliation': 'CHU de Québec-Université Laval, Quebec, Quebec, Canada.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Van Neste', 'Affiliation': 'CHU de Québec-Université Laval, Quebec, Quebec, Canada.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Tremblay', 'Affiliation': 'CHU de Québec-Université Laval, Quebec, Quebec, Canada.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Leblond', 'Affiliation': 'Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS), Quebec, Quebec, Canada.'}, {'ForeName': 'Luc J', 'Initials': 'LJ', 'LastName': 'Hébert', 'Affiliation': 'Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS), Quebec, Quebec, Canada.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14237'] 2254,33621109,ROBUST: A Phase III Study of Lenalidomide Plus R-CHOP Versus Placebo Plus R-CHOP in Previously Untreated Patients With ABC-Type Diffuse Large B-Cell Lymphoma.,"PURPOSE Patients with the activated B-cell-like (ABC) subtype of diffuse large B-cell lymphoma (DLBCL) historically showed inferior survival with standard rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). Phase II studies demonstrated that adding the immunomodulatory agent lenalidomide to R-CHOP improved outcomes in ABC-type DLBCL. The goal of the global, phase III ROBUST study was to compare lenalidomide plus R-CHOP (R2-CHOP) with placebo/R-CHOP in previously untreated, ABC-type DLBCL. METHODS Histology and cell-of-origin type were prospectively analyzed by central pathology prior to random assignment and study treatment. Patients with ABC-DLBCL received lenalidomide oral 15 mg/d, days 1-14/21 plus standard R-CHOP21 versus placebo/R-CHOP21 for six cycles. The primary end point was progression-free survival (PFS) per independent central radiology review. RESULTS A total of 570 patients with ABC-DLBCL (n = 285 per arm) were stratified by International Prognostic Index score, age, and bulky disease, and randomly assigned to R2-CHOP or placebo/R-CHOP. Baseline demographics were similar between arms. Most patients completed six cycles of treatment: 74% R2-CHOP and 84% placebo/R-CHOP. The most common grade 3/4 adverse events for R2-CHOP versus placebo/R-CHOP were neutropenia (60% v 48%), anemia (22% v 14%), thrombocytopenia (17% v 11%), and leukopenia (14% v 15%). The primary end point of PFS was not met, with a hazard ratio of 0.85 (95% CI, 0.63 to 1.14) and P = .29; median PFS has not been reached for either arm. PFS trends favoring R2-CHOP over placebo/R-CHOP were seen in patients with higher-risk disease. CONCLUSION ROBUST is the first DLBCL phase III study to integrate biomarker-driven identification of eligible ABC patients. Although the ROBUST trial did not meet the primary end point of PFS in all patients, the safety profile of R2-CHOP was consistent with individual treatments with no new safety signals.",2021,"The primary end point of PFS was not met, with a hazard ratio of 0.85 (95% CI, 0.63 to 1.14) and ","['Histology and cell-of-origin type were prospectively analyzed by central pathology prior to random assignment and study treatment', 'eligible ABC patients', 'Previously Untreated Patients', '570 patients with ABC-DLBCL (n = 285 per arm) were stratified by International Prognostic Index score, age, and bulky disease', 'patients with higher-risk disease', 'Patients with the activated B-cell-like (ABC) subtype of diffuse large B-cell lymphoma (DLBCL']","['Lenalidomide Plus R-CHOP Versus Placebo Plus R-CHOP', 'rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP', 'lenalidomide plus R-CHOP (R2-CHOP) with placebo/R-CHOP', 'R2-CHOP or placebo/R-CHOP', 'placebo/R-CHOP', 'placebo/R-CHOP21']","['PFS', 'progression-free survival (PFS) per independent central radiology review', 'anemia', 'thrombocytopenia', 'safety profile of R2-CHOP', 'neutropenia', 'leukopenia']","[{'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C1333296', 'cui_str': 'Activated B-cell type diffuse large B-cell lymphoma'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C1512894', 'cui_str': 'International Prognostic Index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0055598', 'cui_str': 'CHOP protocol'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0055598', 'cui_str': 'CHOP protocol'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}]",570.0,0.227269,"The primary end point of PFS was not met, with a hazard ratio of 0.85 (95% CI, 0.63 to 1.14) and ","[{'ForeName': 'Grzegorz S', 'Initials': 'GS', 'LastName': 'Nowakowski', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Chiappella', 'Affiliation': 'Division of Hematology, A.O.U. Città della Salute e della Scienza Hospital and University, Torino, Italy.'}, {'ForeName': 'Randy D', 'Initials': 'RD', 'LastName': 'Gascoyne', 'Affiliation': 'Centre for Lymphoid Cancer, British Columbia Cancer, Vancouver, British Columbia, Canada.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Scott', 'Affiliation': 'Centre for Lymphoid Cancer, British Columbia Cancer, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Qingyuan', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Jurczak', 'Affiliation': 'Maria Sklodowska-Curie Institute-Oncology Centre, Cracow, Poland.'}, {'ForeName': 'Muhit', 'Initials': 'M', 'LastName': 'Özcan', 'Affiliation': 'Department of Hematology, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Xiaonan', 'Initials': 'X', 'LastName': 'Hong', 'Affiliation': 'Cancer Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Beijing Cancer Hospital, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'The First Affiliated Hospital of Medical School of Zhejiang University, First Hospital of Zhejiang Province, Hangzhou, Zhejiang, China.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Belada', 'Affiliation': 'Fourth Department of Internal Medicine-Hematology, Charles University Hospital and Faculty of Medicine, Hradec Králové, Czech Republic.'}, {'ForeName': 'Juan Miguel', 'Initials': 'JM', 'LastName': 'Bergua', 'Affiliation': 'Servicio de Hematologia, Hospital Universitario San Pedro de Alcántara, Cáceres, Spain.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Piazza', 'Affiliation': 'Division of Hematology, Department of Medicine, University of Padova and Azienda Ospedaliera di Padova, Padova, Italy.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Mócikova', 'Affiliation': 'Department of Internal Medicine and Haematology, Faculty Hospital Kralovske Vinohrady, Prague, Czech Republic.'}, {'ForeName': 'Anna Lia', 'Initials': 'AL', 'LastName': 'Molinari', 'Affiliation': 'UO Ematologia, Ospedale Degli Infermi, Rimini, Italy.'}, {'ForeName': 'Dok Hyun', 'Initials': 'DH', 'LastName': 'Yoon', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Cavallo', 'Affiliation': 'AOU Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Tani', 'Affiliation': 'U.O. Ematologia, Dipartimento Oncologia e Ematologia, Ospedale Santa Maria delle Croci, Ravenna, Italy.'}, {'ForeName': 'Kazuhito', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Hematology and Cell Therapy, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Izutsu', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Kato', 'Affiliation': 'Department of Medicine and Biosystemic Science, Kyushu University Faculty of Medicine, Fukuoka City, Japan.'}, {'ForeName': 'Myron', 'Initials': 'M', 'LastName': 'Czuczman', 'Affiliation': 'Clinical Research and Development, Celgene Corporation, Summit, NJ.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hersey', 'Affiliation': 'Translational Development, Precision Medicine and Companion Diagnostics, Celgene Corporation, Summit, NJ.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Kilcoyne', 'Affiliation': 'Clinical Research and Development, Celgene Corporation, Summit, NJ.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Russo', 'Affiliation': 'Clinical Research and Development, Celgene Corporation, Summit, NJ.'}, {'ForeName': 'Krista', 'Initials': 'K', 'LastName': 'Hudak', 'Affiliation': 'Clinical Research and Development, Celgene Corporation, Summit, NJ.'}, {'ForeName': 'Jingshan', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Clinical Research and Development, Celgene Corporation, Summit, NJ.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Wade', 'Affiliation': 'Department of Statistical Programming, Celgene Corporation, Overland Park, KS.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Witzig', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Vitolo', 'Affiliation': 'Division of Hematology, A.O.U. Città della Salute e della Scienza Hospital and University, Torino, Italy.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01366'] 2255,33625508,Cost-effectiveness of Atezolizumab Plus Bevacizumab vs Sorafenib as First-Line Treatment of Unresectable Hepatocellular Carcinoma.,"Importance Treatment with atezolizumab plus bevacizumab may prolong overall survival among patients with unresectable hepatocellular carcinoma. However, to our knowledge, the cost-effectiveness of using this high-priced therapy for this indication is currently unknown. Objective To evaluate the cost-effectiveness of atezolizumab plus bevacizumab to treat unresectable hepatocellular carcinoma from the US payer perspective. Design, Setting, and Participants This economic evaluation used a partitioned survival model consisting of 3 discrete health states to assess the cost-effectiveness of treatment of hepatocellular carcinoma with atezolizumab plus bevacizumab vs sorafenib. The characteristics of patients in the model were similar to patients in a phase 3, open-label randomized clinical trial (IMbrave150) who had unresectable hepatocellular carcinoma and had not previously received systemic treatment. Key clinical data were generated from the IMbrave150 trial conducted between March 15, 2018, and January 30, 2019, and cost and health preference data were collected from the literature. Main Outcomes and Measures Costs, quality-adjusted life-years (QALYs), incremental cost-utility ratios, incremental net health benefits, and incremental net monetary benefits were calculated for the 2 treatment strategies. Subgroup, 1-way sensitivity, and probabilistic sensitivity analyses were performed. Results Treatment of hepatocellular carcinoma with atezolizumab plus bevacizumab added 0.530 QALYs and resulted in an incremental cost of $89 807 compared with sorafenib therapy, which had an incremental cost-utility ratio of $169 223 per QALY gained. The incremental net health benefit was -0.068 QALYs, and the incremental net monetary benefit was -$10 202 at a willingness-to-pay threshold of $150 000/QALY. The probabilistic sensitivity analysis indicated that treatment with atezolizumab plus bevacizumab achieved a 35% probability of cost-effectiveness at a threshold of $150 000/QALY. One-way sensitivity analysis revealed that the results were most sensitive to the hazard ratio of overall survival. The subgroup analysis found that treatment with atezolizumab plus bevacizumab was associated with preferred incremental net health benefits in several subgroups, including patients with hepatitis B and C. Conclusions and Relevance Atezolizumab plus bevacizumab treatment is unlikely to be a cost-effective option compared with sorafenib for patients with unresectable hepatocellular carcinoma. Reducing the prices of atezolizumab and bevacizumab may improve cost-effectiveness. The economic outcomes also may be improved by tailoring treatments based on individual patient factors.",2021,"Results Treatment of hepatocellular carcinoma with atezolizumab plus bevacizumab added 0.530 QALYs and resulted in an incremental cost of $89 807 compared with sorafenib therapy, which had an incremental cost-utility ratio of $169 223 per QALY gained.","['patients with unresectable hepatocellular carcinoma', 'Unresectable Hepatocellular Carcinoma', 'patients in the model were similar to patients in a phase 3, open-label randomized clinical trial (IMbrave150) who had unresectable hepatocellular carcinoma and had not previously received systemic treatment']","['Atezolizumab Plus Bevacizumab vs Sorafenib', 'bevacizumab', 'atezolizumab plus bevacizumab vs sorafenib', 'atezolizumab and bevacizumab', 'atezolizumab plus bevacizumab', 'sorafenib']","['cost-effectiveness', 'hazard ratio of overall survival', 'incremental cost-utility ratio', '1-way sensitivity, and probabilistic sensitivity analyses', 'incremental cost', 'incremental net health benefit', 'Measures\n\n\nCosts, quality-adjusted life-years (QALYs), incremental cost-utility ratios, incremental net health benefits, and incremental net monetary benefits', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1112459', 'cui_str': 'Liver cell carcinoma non-resectable'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0086387', 'cui_str': 'Health Benefits'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",,0.0816223,"Results Treatment of hepatocellular carcinoma with atezolizumab plus bevacizumab added 0.530 QALYs and resulted in an incremental cost of $89 807 compared with sorafenib therapy, which had an incremental cost-utility ratio of $169 223 per QALY gained.","[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Su', 'Affiliation': 'Department of Pharmacy, The First Affiliated Hospital of University of Science and Technology of China, Hefei, Anhui, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Medical Decision and Economic Group, Department of Pharmacy, Ren Ji Hospital, South Campus, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Lizheng', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Department of Global Health Management and Policy, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}]",JAMA network open,['10.1001/jamanetworkopen.2021.0037'] 2256,33625476,Effect of Subcutaneous Semaglutide vs Placebo as an Adjunct to Intensive Behavioral Therapy on Body Weight in Adults With Overweight or Obesity: The STEP 3 Randomized Clinical Trial.,"Importance Weight loss improves cardiometabolic risk factors in people with overweight or obesity. Intensive lifestyle intervention and pharmacotherapy are the most effective noninvasive weight loss approaches. Objective To compare the effects of once-weekly subcutaneous semaglutide, 2.4 mg vs placebo for weight management as an adjunct to intensive behavioral therapy with initial low-calorie diet in adults with overweight or obesity. Design, Setting, and Participants Randomized, double-blind, parallel-group, 68-week, phase 3a study (STEP 3) conducted at 41 sites in the US from August 2018 to April 2020 in adults without diabetes (N = 611) and with either overweight (body mass index ≥27) plus at least 1 comorbidity or obesity (body mass index ≥30). Interventions Participants were randomized (2:1) to semaglutide, 2.4 mg (n = 407) or placebo (n = 204), both combined with a low-calorie diet for the first 8 weeks and intensive behavioral therapy (ie, 30 counseling visits) during 68 weeks. Main Outcomes and Measures The co-primary end points were percentage change in body weight and the loss of 5% or more of baseline weight by week 68. Confirmatory secondary end points included losses of at least 10% or 15% of baseline weight. Results Of 611 randomized participants (495 women [81.0%], mean age 46 years [SD, 13], body weight 105.8 kg [SD, 22.9], and body mass index 38.0 [SD, 6.7]), 567 (92.8%) completed the trial, and 505 (82.7%) were receiving treatment at trial end. At week 68, the estimated mean body weight change from baseline was -16.0% for semaglutide vs -5.7% for placebo (difference, -10.3 percentage points [95% CI, -12.0 to -8.6]; P < .001). More participants treated with semaglutide vs placebo lost at least 5% of baseline body weight (86.6% vs 47.6%, respectively; P < .001). A higher proportion of participants in the semaglutide vs placebo group achieved weight losses of at least 10% or 15% (75.3% vs 27.0% and 55.8% vs 13.2%, respectively; P < .001). Gastrointestinal adverse events were more frequent with semaglutide (82.8%) vs placebo (63.2%). Treatment was discontinued owing to these events in 3.4% of semaglutide participants vs 0% of placebo participants. Conclusions and Relevance Among adults with overweight or obesity, once-weekly subcutaneous semaglutide compared with placebo, used as an adjunct to intensive behavioral therapy and initial low-calorie diet, resulted in significantly greater weight loss during 68 weeks. Further research is needed to assess the durability of these findings. Trial Registration ClinicalTrials.gov Identifier: NCT03611582.",2021,Gastrointestinal adverse events were more frequent with semaglutide (82.8%) vs placebo (63.2%).,"['Adults With Overweight or Obesity', '41 sites in the US from August 2018 to April 2020 in adults without diabetes (N\u2009=\u2009611) and with either overweight (body mass index ≥27) plus at least 1 comorbidity or obesity (body mass index ≥30', 'adults with overweight or obesity', 'people with overweight or obesity', 'adults with overweight or obesity, once-weekly subcutaneous semaglutide compared with', '611 randomized participants (495 women [81.0%], mean age 46 years [SD, 13], body weight 105.8 kg [SD, 22.9], and body mass index 38.0 [SD, 6.7]), 567 (92.8%) completed the trial, and 505 (82.7%) were receiving treatment at trial end']","['intensive behavioral therapy with initial low-calorie diet', 'once-weekly subcutaneous semaglutide, 2.4 mg vs placebo', 'placebo', 'Subcutaneous Semaglutide vs Placebo', 'combined with a low-calorie diet for the first 8 weeks and intensive behavioral therapy', 'semaglutide vs placebo', 'Intensive lifestyle intervention and pharmacotherapy', 'Intensive Behavioral Therapy']","['weight loss', 'weight losses', 'body weight and the loss of 5% or more of baseline weight', 'mean body weight change', 'Body Weight', 'cardiometabolic risk factors', 'Gastrointestinal adverse events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444930', 'cui_str': 'End'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1303013', 'cui_str': 'Baseline weight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",611.0,0.341192,Gastrointestinal adverse events were more frequent with semaglutide (82.8%) vs placebo (63.2%).,"[{'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Timothy S', 'Initials': 'TS', 'LastName': 'Bailey', 'Affiliation': 'AMCR Institute, Escondido, California.'}, {'ForeName': 'Liana K', 'Initials': 'LK', 'LastName': 'Billings', 'Affiliation': 'Department of Medicine, NorthShore University HealthSystem/University of Chicago Pritzker School of Medicine, Skokie, Illinois.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Frias', 'Affiliation': 'National Research Institute, Los Angeles, California.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Koroleva', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Ildiko', 'Initials': 'I', 'LastName': 'Lingvay', 'Affiliation': 'Departments of Internal Medicine/Endocrinology and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': ""O'Neil"", 'Affiliation': 'Weight Management Center, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Domenica M', 'Initials': 'DM', 'LastName': 'Rubino', 'Affiliation': 'Washington Center for Weight Management and Research, Arlington, Virginia.'}, {'ForeName': 'Dorthe', 'Initials': 'D', 'LastName': 'Skovgaard', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Signe O R', 'Initials': 'SOR', 'LastName': 'Wallenstein', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'W Timothy', 'Initials': 'WT', 'LastName': 'Garvey', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2021.1831'] 2257,33635325,Effect of Collaborative Care on Persistent Postconcussive Symptoms in Adolescents: A Randomized Clinical Trial.,"Importance Despite the high level of impairment for adolescents with persistent postconcussive symptoms, few studies have tested whether such problems can be remediated. Objective To examine whether collaborative care treatment is associated with improvements in postconcussive, quality of life, anxiety, and depressive symptoms over 1 year, compared with usual care. Design, Setting, and Participants The Collaborative Care Model for Treatment of Persistent Symptoms After Concussion Among Youth II Trial was a randomized clinical trial conducted from March 2017 to May 2020 with follow-up assessments at 3, 6, and 12 months. Participants were recruited from pediatric primary care, sports medicine, neurology, and rehabilitation clinics in western Washington. Adolescents aged 11 to 18 years with a diagnosed sports-related or recreational-related concussion within the past 9 months and with at least 3 symptoms persisting at least 1 month after injury were eligible. Data analysis was performed from June to September 2020. Interventions The collaborative care intervention included cognitive behavioral therapy and care management, delivered mostly through telehealth, throughout the 6-month treatment period, with enhanced medication consultation when warranted. The comparator group was usual care provided in specialty clinics. Main Outcomes and Measures Primary outcomes were adolescents' reports of postconcussive, quality of life, anxiety, and depressive symptoms. Secondary outcomes were parent-reported symptoms. Results Of the 390 eligible adolescents, 201 (51.5%) agreed to participate, and 200 were enrolled (mean [SD] age, 14.7 [1.7] years; 124 girls [62.0%]), with 96% to 98% 3- to 12-month retention. Ninety-nine participants were randomized to usual care, and 101 were randomized to collaborative care. Adolescents who received collaborative care reported significant improvements in Health Behavior Inventory scores compared with usual care at 3 months (3.4 point decrease; 95% CI, -6.6 to -0.1 point decrease) and 12 months (4.1 point decrease; 95% CI, -7.7 to -0.4 point decrease). In addition, youth-reported Pediatric Quality of Life Inventory scores at 12 months improved by a mean of 4.7 points (95% CI, 0.05 to 9.3 points) in the intervention group compared with the control group. No differences emerged by group over time for adolescent depressive or anxiety symptoms or for parent-reported outcomes. Conclusions and Relevance Although both groups improved over time, youth receiving the collaborative care intervention had fewer symptoms and better quality of life over 1 year. Intervention delivery through telehealth broadens the reach of this treatment. Trial Registration ClinicalTrials.gov Identifier: NCT03034720.",2021,"Adolescents who received collaborative care reported significant improvements in Health Behavior Inventory scores compared with usual care at 3 months (3.4 point decrease; 95% CI, -6.6 to -0.1 point decrease) and 12 months (4.1 point decrease; 95% CI, -7.7 to -0.4 point decrease).","['Ninety-nine participants', 'Adolescents aged 11 to 18 years with a diagnosed sports-related or recreational-related concussion within the past 9 months and with at least 3 symptoms persisting at least 1 month after injury were eligible', 'March 2017 to May 2020 with follow-up assessments at 3, 6, and 12 months', 'adolescents with persistent postconcussive symptoms', '390 eligible adolescents, 201 (51.5%) agreed to participate, and 200 were enrolled (mean [SD] age, 14.7 [1.7] years; 124 girls [62.0%]), with 96% to 98% 3- to 12-month retention', 'Adolescents', 'Participants were recruited from pediatric primary care, sports medicine, neurology, and rehabilitation clinics in western Washington']","['collaborative care intervention included cognitive behavioral therapy and care management, delivered mostly through telehealth', 'Collaborative Care']","['Health Behavior Inventory scores', 'symptoms and better quality of life', ""adolescents' reports of postconcussive, quality of life, anxiety, and depressive symptoms"", 'postconcussive, quality of life, anxiety, and depressive symptoms', 'adolescent depressive or anxiety symptoms', 'parent-reported symptoms', 'Pediatric Quality of Life Inventory scores']","[{'cui': 'C3828813', 'cui_str': '99'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0038040', 'cui_str': 'Medicine, Sport'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C3839785', 'cui_str': 'Rehabilitation clinic'}, {'cui': 'C0043038', 'cui_str': 'Washington'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]",99.0,0.17981,"Adolescents who received collaborative care reported significant improvements in Health Behavior Inventory scores compared with usual care at 3 months (3.4 point decrease; 95% CI, -6.6 to -0.1 point decrease) and 12 months (4.1 point decrease; 95% CI, -7.7 to -0.4 point decrease).","[{'ForeName': 'Carolyn A', 'Initials': 'CA', 'LastName': 'McCarty', 'Affiliation': ""Seattle Children's Research Institute, Center for Child Health, Behavior and Development, University of Washington, Seattle.""}, {'ForeName': 'Douglas F', 'Initials': 'DF', 'LastName': 'Zatzick', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle.'}, {'ForeName': 'Lyscha A', 'Initials': 'LA', 'LastName': 'Marcynyszyn', 'Affiliation': ""Seattle Children's Research Institute, Center for Child Health, Behavior and Development, University of Washington, Seattle.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Harborview Injury Prevention and Research Center, University of Washington, Seattle.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hilt', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jinguji', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle.'}, {'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Quitiquit', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle.'}, {'ForeName': 'Sara P D', 'Initials': 'SPD', 'LastName': 'Chrisman', 'Affiliation': ""Seattle Children's Research Institute, Center for Child Health, Behavior and Development, University of Washington, Seattle.""}, {'ForeName': 'Frederick P', 'Initials': 'FP', 'LastName': 'Rivara', 'Affiliation': ""Seattle Children's Research Institute, Center for Child Health, Behavior and Development, University of Washington, Seattle.""}]",JAMA network open,['10.1001/jamanetworkopen.2021.0207'] 2258,33636650,Effects of self-healing intervention on quality of life and mother-child interaction among female breadwinners.,"OBJECTIVES This study aimed to investigate the effectiveness of self-healing (the healing codes) intervention on quality of life (QoL) and mother-child interaction among female breadwinners. METHODS The study population comprised all female breadwinners who referred to the welfare centers of Isfahan in 2020; using convenience sampling, we selected 30 women and divided them into experimental and control groups (n = 15 per group). The experimental group underwent fourteen sessions (90-min sessions per week) of self-healing training. RESULTS The mean ± SD of QoL and mother-child interaction for experimental and control groups in the post-test stage were 84.33 ± 3.92 and 160.86 ± 8.74 respectively. Self-healing intervention had significant effects on QoL and mother-child interaction among female breadwinners. The intervention program improved the components of QoL and mother-child interaction among female breadwinners (p < 0.01). CONCLUSIONS Self-healing training can be used as a novel approach to enhance QoL and mother-child interaction in this group of women.",2021,"The intervention program improved the components of QoL and mother-child interaction among female breadwinners (p < 0.01). ","['study population comprised all female breadwinners who referred to the welfare centers of Isfahan in 2020; using', 'female breadwinners']","['self-healing intervention', 'Self-healing intervention', 'self-healing (the healing codes) intervention', 'convenience sampling', 'self-healing training']","['quality of life (QoL', 'mean\xa0±\xa0SD of QoL and mother-child interaction', 'QoL and mother-child interaction', 'quality of life and mother-child interaction']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0037440', 'cui_str': 'Social services'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0885003', 'cui_str': 'Xiakucao'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0026590', 'cui_str': 'Mother-Child Relationship'}]",30.0,0.0108561,"The intervention program improved the components of QoL and mother-child interaction among female breadwinners (p < 0.01). ","[{'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Zarean', 'Affiliation': 'Department of Education and Psychology, University of Mohaghegh Ardabili, Ardabil, Iran. Electronic address: zareanfah@gmail.com.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Latifi', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101334'] 2259,33610177,Costs of health and social services use in children of parents with mental illness.,"BACKGROUND Children of parents with mental illness have a higher risk of developing mental health problems when compared with the general population. Therefore, families with parents with mental illness are a suitable target group for selective prevention. In order to plan and evaluate the health economic consequences of preventive interventions for this target group, data on the societal costs related to parenthood under the condition of mental disorders are needed. To date, within Germany there has been a lack of research evaluating the costs of mental health treatment and use of social services by children and adolescents with parents with mental illness. METHODS As part of a multicentre randomised controlled trial, use and costs of health and social services were assessed for a sample of 332 children and adolescents with parents with mental illness in six regions of Germany. Service use at baseline was assessed by the German version of the Children and Adolescent Mental Health Service Receipt Inventory. Costs were calculated for 12 months based on diagnosis and service user status and described separately. Cost drivers were identified by means of a two-part regression model. RESULTS Total mean costs for 12 months for the total sample amount of € 3736.35 (95% CI: € 2816.84-4813.83) per person. Children with a psychiatric diagnosis generated a total of € 5691.93 (95% CI: € 4146.27-7451.38) of costs per person, compared to € 1245.01 (95% CI: € 657.44-1871.49) for children without a psychiatric diagnosis. The logit part indicates significant odds ratios for individual functioning and diagnosis of the child as well as for family functioning. The linear part reveals that increasing individual functioning in the child is related to decreasing costs. CONCLUSIONS Children of families with parents with mental illness use a broad spectrum of mental health care, school-based support and youth welfare services even if they are not yet diagnosed as having a mental disorder. Further research should examine whether these institutions are sufficiently qualified and interlinked to meet the support needs of this vulnerable group. Trial registration The study was registered at the 07/10/2014 before the start of data collection (04/11/2014) at the German clinical trials register (Deutsches Register Klinischer Studien, DRKS, nr: DRKS00006806, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00006806 ).",2021,"RESULTS Total mean costs for 12 months for the total sample amount of € 3736.35","['children of parents with mental illness', 'families with parents with mental illness', 'Children of parents with mental illness', '332 children and adolescents with parents with mental illness in six regions of Germany', 'children and adolescents with parents with mental illness', 'Children of families with parents with mental illness']",[],"['Costs of health and social services', 'Costs']","[{'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]",[],"[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}]",332.0,0.187239,"RESULTS Total mean costs for 12 months for the total sample amount of € 3736.35","[{'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Waldmann', 'Affiliation': 'Department of Psychiatry and Psychotherapy II, University of Ulm and BKH Günzburg, Lindenallee 2, 89312, Günzburg, Germany. tamara.waldmann@uni-ulm.de.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Stiawa', 'Affiliation': 'Department of Psychiatry and Psychotherapy II, University of Ulm and BKH Günzburg, Lindenallee 2, 89312, Günzburg, Germany.'}, {'ForeName': 'Ümügülsüm', 'Initials': 'Ü', 'LastName': 'Dinc', 'Affiliation': 'Department of Psychiatry and Psychotherapy II, University of Ulm and BKH Günzburg, Lindenallee 2, 89312, Günzburg, Germany.'}, {'ForeName': 'Gülsah', 'Initials': 'G', 'LastName': 'Saglam', 'Affiliation': 'Department of Psychiatry and Psychotherapy II, University of Ulm and BKH Günzburg, Lindenallee 2, 89312, Günzburg, Germany.'}, {'ForeName': 'Mareike', 'Initials': 'M', 'LastName': 'Busmann', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Daubmann', 'Affiliation': 'Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Adema', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Wegscheider', 'Affiliation': 'Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Wiegand-Grefe', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Reinhold', 'Initials': 'R', 'LastName': 'Kilian', 'Affiliation': 'Department of Psychiatry and Psychotherapy II, University of Ulm and BKH Günzburg, Lindenallee 2, 89312, Günzburg, Germany.'}]",Child and adolescent psychiatry and mental health,['10.1186/s13034-021-00360-y'] 2260,33820426,Changes in Heart Rate Variability Following Acoustic Therapy in Individuals With Tinnitus.,"Purpose The aim of the study was to investigate changes in autonomic function, as measured by heart rate variability, in individuals with tinnitus following acoustic therapy implemented using tinnitus maskers presented via hearing aids. Method Twenty-six individuals with tinnitus and hearing impairment completed an 8-week field trial wearing hearing aids providing acoustic therapy via three tinnitus masker options set just below minimum masking level. Tinnitus handicap was measured using the Tinnitus Handicap Inventory at baseline (before starting acoustic therapy) and posttreatment (at end of 8-week trial). Resting heart rate and heart rate variability were measured using electrocardiography at baseline and posttreatment. Results There was a significant decrease in tinnitus handicap posttreatment compared to baseline. There was no change in heart rate, but there was a significant increase in heart rate variability posttreatment compared to baseline. Conclusions Acoustic therapy using tinnitus maskers delivered via hearing aids provided tinnitus relief and produced a concurrent increase in heart rate variability, suggesting a decrease in stress. Heart rate variability is a potential biomarker for tracking efficacy of acoustic therapy; however, further research is required.",2021,"There was no change in heart rate, but there was a significant increase in heart rate variability posttreatment compared to baseline.","['individuals with tinnitus following acoustic therapy implemented using tinnitus maskers presented via hearing aids', 'Individuals With Tinnitus', 'Method Twenty-six individuals with tinnitus and hearing impairment']","['Acoustic Therapy', 'acoustic therapy', 'hearing aids providing acoustic therapy via three tinnitus masker options set just below minimum masking level']","['Resting heart rate and heart rate variability', 'Tinnitus Handicap Inventory', 'heart rate variability', 'tinnitus handicap posttreatment', 'heart rate', 'Heart Rate Variability', 'autonomic function', 'Tinnitus handicap', 'heart rate variability posttreatment']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0492828', 'cui_str': 'Tinnitus masker'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0018768', 'cui_str': 'Hearing aid'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]","[{'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018768', 'cui_str': 'Hearing aid'}, {'cui': 'C0492828', 'cui_str': 'Tinnitus masker'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",26.0,0.0439581,"There was no change in heart rate, but there was a significant increase in heart rate variability posttreatment compared to baseline.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Reinhart', 'Affiliation': 'Starkey Hearing Technologies, Eden Prairie, MN.'}, {'ForeName': 'Kendra', 'Initials': 'K', 'LastName': 'Griffin', 'Affiliation': 'Starkey Hearing Technologies, Eden Prairie, MN.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Micheyl', 'Affiliation': 'Starkey France, Creteil.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2021_JSLHR-20-00596'] 2261,33621782,"A preliminary study on the effects of the Peer-Led Self-Management (PLSM) program on self-efficacy, self-management, and physiological measures in older adults with diabetes: A block randomized controlled trial.","This study explored the effects and feasibility of the peer-led self-management (PLSM) program for older adults with diabetes. Twenty-eight participants from 10 communities in southern Taiwan were randomly allocated to experimental and control groups. Those in the experimental group were enrolled in a 4-week PLSM program; those in the control group received a self-management manual and continued their usual clinical care. Improvement in outcomes (self-efficacy, self-management, physiological measures) over time in both groups were evaluated. After PLSM intervention, self-efficacy and self-management had improved; body weight and body mass index measures of the experimental group at post-test 1 and post-test 2 were significantly lower than those of the control group (p < .001); HbA1c, total cholesterol, and triglycerides at post-test 2 were also significantly better (p < .001; p = .03; p = .02). We discuss preliminary benefits and feasibility of the PLSM program.",2021,This study explored the effects and feasibility of the peer-led self-management (PLSM) program for older adults with diabetes.,"['Twenty-eight participants from 10 communities in southern Taiwan', 'older adults with diabetes']","['self-management manual and continued their usual clinical care', 'Peer-Led Self-Management (PLSM) program', 'peer-led self-management (PLSM) program']","['HbA1c, total cholesterol, and triglycerides', 'outcomes (self-efficacy, self-management, physiological measures', ' body weight and body mass index measures', 'self-efficacy, self-management, and physiological measures']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",28.0,0.018694,This study explored the effects and feasibility of the peer-led self-management (PLSM) program for older adults with diabetes.,"[{'ForeName': 'Wen-Chun', 'Initials': 'WC', 'LastName': 'Chen', 'Affiliation': 'Department of Community Medicine, St. Martin De Porres Hospital, Chiayi, Taiwan; School of Nursing, Kaohsiung Medical University, Kaohsiung, Taiwan; Department of Nursing, Chang Gung University of Science and Technology, Chiayi Campus, Taiwan. Electronic address: shermie@stm.org.tw.'}, {'ForeName': 'Chia-Chi', 'Initials': 'CC', 'LastName': 'Kuo', 'Affiliation': 'Emergency Department, Chi-Mei Medical Center, Tainan, Taiwan; Department of Nursing, Chang Jung Christian University, Tainan, Taiwan.'}, {'ForeName': 'Chiu-Chu', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'School of Nursing, Kaohsiung Medical University, Kaohsiung, Taiwan; Department of Renal Care, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan; Department of Medical Research, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan. Electronic address: chiuchu@kmu.edu.tw.'}, {'ForeName': 'Chia-Chen', 'Initials': 'CC', 'LastName': 'Wu', 'Affiliation': 'School of Nursing, Fooyin University, Kaohsiung, Taiwan.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2021.01.011'] 2262,33620895,Comparison of 100 U With 200 U of Intradetrusor OnabotulinumToxinA for Nonneurogenic Urgency Incontinence.,"OBJECTIVES The objective of this study was to compare efficacy and adverse events between 100 U and 200 U of onabotulinumtoxinA for 6 months in women with nonneurogenic urgency incontinence. METHODS This is a secondary analysis of 2 multicenter randomized controlled trials assessing efficacy of onabotulinumtoxinA in women with nonneurogenic urgency incontinence; one compared 100 U to anticholinergics and the other 200 U to sacral neuromodulation. Of 307 women who received onabotulinumtoxinA injections, 118 received 100 U, and 189 received 200 U. The primary outcome was mean adjusted change in daily urgency incontinence episodes from baseline over 6 months, measured on monthly bladder diaries. Secondary outcomes included perceived improvement, quality of life, and adverse events. The primary outcome was assessed via a multivariate linear mixed model. RESULTS Women receiving 200 U had a lower mean reduction in urgency incontinence episodes by 6 months compared with 100 U (-3.65 vs -4.28 episodes per day; mean difference, 0.63 episodes per day [95% confidence interval (CI), 0.05-1.20]). Women receiving 200 U had lower perceptions of improvement (adjusted odds ratio, 0.32 [95% CI, 0.14-0.75]) and smaller improvement in severity score (adjusted mean difference, 12.0 [95% CI, 5.63-18.37]). Upon subanalysis of only women who were treated with prior anticholinergic medications, these differences between onabotulinumtoxinA doses were no longer statistically significant. There was no statistically significant difference in adverse events in women receiving 200 U (catheterization, 32% vs 23%; adjusted odds ratio, 1.4 [95% CI, 0.8-2.4]; urinary tract infection, 37% vs 27%; adjusted odds ratio, 1.5 [95% CI, 0.9-2.6]). CONCLUSIONS A higher dose of onabotulinumtoxinA may not directly result in improved outcomes, but rather baseline disease severity may be a more important prediction of outcomes.",2021,"Women receiving 200 U had lower perceptions of improvement (adjusted odds ratio, 0.32","['Nonneurogenic Urgency Incontinence', '307 women who received onabotulinumtoxinA injections, 118 received 100 U, and 189 received 200 U', 'women with nonneurogenic urgency incontinence']","['onabotulinumtoxinA', '100 U With 200 U of Intradetrusor OnabotulinumToxinA']","['severity score', 'mean adjusted change in daily urgency incontinence episodes', 'efficacy and adverse events', 'improvement, quality of life, and adverse events', 'urgency incontinence episodes', 'urinary tract infection', 'monthly bladder diaries', 'adverse events']","[{'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart'}]",307.0,0.551267,"Women receiving 200 U had lower perceptions of improvement (adjusted odds ratio, 0.32","[{'ForeName': 'Whitney K', 'Initials': 'WK', 'LastName': 'Hendrickson', 'Affiliation': 'From the Division of Urogynecology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Cindy L', 'Initials': 'CL', 'LastName': 'Amundsen', 'Affiliation': 'From the Division of Urogynecology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Rahn', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, UT Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Isuzu', 'Initials': 'I', 'LastName': 'Meyer', 'Affiliation': 'Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Megan S', 'Initials': 'MS', 'LastName': 'Bradley', 'Affiliation': 'Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics, Gynecology and Reproductive Services, School of Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Ariana L', 'Initials': 'AL', 'LastName': 'Smith', 'Affiliation': 'Division of Urology, Department of Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': 'Myers', 'Affiliation': 'Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, Brown University, Providence, RI.'}, {'ForeName': 'J Eric', 'Initials': 'JE', 'LastName': 'Jelovsek', 'Affiliation': 'From the Division of Urogynecology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Lukacz', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics, Gynecology and Reproductive Sciences, UC San Diego, San Diego, CA.'}]",Female pelvic medicine & reconstructive surgery,['10.1097/SPV.0000000000001020'] 2263,33625291,"Patterns and predictors of air purifier adherence in children with asthma living in low-income, urban households.","OBJECTIVE Black children and children from low-income communities are disproportionately affected by asthma, attributed partly to pollution exposure. Air purifiers reduce indoor air pollution and improve asthma symptoms in children. In order to implement air purifier interventions, an understanding of patterns of use and potential barriers is necessary. METHODS In a home intervention study, 127 children with asthma living in Baltimore were randomized to receive two active or two placebo air purifiers. The 16-week study period included: baseline clinic visit, home visit for air purifier installation (active or placebo) with instruction to use the high or turbo settings, and electronic adherence monitoring of air purifiers. Determinants of adherence were identified using linear regression models. RESULTS Air purifiers were used 80% of the time, and participants demonstrated adherence to high or turbo settings for 60% of the time. In an adjusted model, season was the major determinant of air purifier adherence, with 21% lower use in the winter ( p  = 0.025) attributed to the cold draft generated by the machine. CONCLUSION In a clinical trial with electronic adherence monitoring, air purifier use was high and participants were adherent to use of high or turbo settings the majority of the time. Addressing practical barriers to consistent use, such as draft during the winter, in addition to financial barriers may improve air purifier adherence among children with asthma living in low-income, urban households. CLINICAL TRIALS REGISTRY NUMBER NCT02763917.",2021,"In an adjusted model, season was the major determinant of air purifier adherence, with 21% lower use in the winter ( p  = 0.025) attributed to the cold draft generated by the machine.","['children with asthma living in low-income, urban households', 'children', 'Children with Asthma Living in Low-Income, Urban Households', '127 children with asthma living in Baltimore', 'Black children and children from low-income communities']","['baseline clinic visit, home visit for air purifier installation (active or placebo) with instruction to use the high or turbo settings, and electronic adherence monitoring of air purifiers', 'placebo']",['adherence to high or turbo settings'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0262774', 'cui_str': 'Air Purifier'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205250', 'cui_str': 'High'}]",127.0,0.0366453,"In an adjusted model, season was the major determinant of air purifier adherence, with 21% lower use in the winter ( p  = 0.025) attributed to the cold draft generated by the machine.","[{'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Kaviany', 'Affiliation': 'Department of Pediatric Pulmonology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Emily P', 'Initials': 'EP', 'LastName': 'Brigham', 'Affiliation': 'Department of Pulmonology and Critical Care, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Collaco', 'Affiliation': 'Department of Pulmonology and Critical Care, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Rice', 'Affiliation': 'Department of Pediatric Pulmonology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Woo', 'Affiliation': 'Department of Pulmonology and Critical Care, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Wood', 'Affiliation': 'Department of Environmental and Health Engineering, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Koehl', 'Affiliation': 'Department of Pulmonology and Critical Care, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Tianshi D', 'Initials': 'TD', 'LastName': 'Wu', 'Affiliation': 'Department of Pulmonology and Critical Care, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Michelle N', 'Initials': 'MN', 'LastName': 'Eakin', 'Affiliation': 'Department of Pulmonology and Critical Care, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Koehler', 'Affiliation': 'Department of Environmental and Health Engineering, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Nadia N', 'Initials': 'NN', 'LastName': 'Hansel', 'Affiliation': 'Department of Pulmonology and Critical Care, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Meredith C', 'Initials': 'MC', 'LastName': 'McCormack', 'Affiliation': 'Department of Pulmonology and Critical Care, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2021.1893745'] 2264,33622370,"CRBP-TS - evaluation of a home-based training and health care program for colorectal, breast, and prostate cancer using telemonitoring and self-management: study protocol for a randomized controlled trial.","BACKGROUND Physical training is recommended in various national and international guidelines for patients with cancer. Observational studies have shown that physical activity leads to reduced recurrence and mortality rates by 20-40% in colorectal, breast, and prostate cancer. Despite existing evidence, a systematic care structure is still lacking. The primary aim of this study is to implement and evaluate an online training platform to strengthen physical performance and patient empowerment after cancer surgery. METHODS The evaluation will be conducted as a prospective multicenter randomized controlled trial with three subgroups (colorectal-, breast-, and prostate cancer). Each group will include 100 patients (total 300 patients including dropouts; clinical stages T1-3 and/or N+; M0 after surgery intervention) and the primary endpoint (13% increase in the maximal oxygen consumption during exercise) will be examined. The intervention group will receive a 6-month home-based online training (2-3 times per week strength-endurance training using video presentations), bidirectional activity feedback information, online communication, and online counseling. The control group (usual care) will be advised lifestyle improvement. In-hospital testing will be performed before, during, and after the intervention. In addition to cardiopulmonary capacity, tumor specific diagnostics (liquid biopsy, depression and fatigue assessment, metabolic and endothelial screening) will be applied. DISCUSSION Due to the increasing incidence of cancer, associated with considerable mortality, morbidity and impaired quality of life, there is an imperative requirement for improved cancer care, of which structured physical training may become an integral component. TRIAL REGISTRATION DRKS-ID: DRKS00020499 ; Registered 17 March 2020.",2021,"Observational studies have shown that physical activity leads to reduced recurrence and mortality rates by 20-40% in colorectal, breast, and prostate cancer.","['patients with cancer', 'three subgroups (colorectal-, breast-, and prostate cancer', '100 patients (total 300 patients including dropouts; clinical stages T1-3 and/or N+; M0 after surgery intervention']","['6-month home-based online training (2-3 times per week strength-endurance training using video presentations), bidirectional activity feedback information, online communication, and online counseling', 'CRBP-TS - evaluation of a home-based training and health care program', 'online training platform', 'DRKS-ID', 'Physical training']","['cardiopulmonary capacity, tumor specific diagnostics (liquid biopsy, depression and fatigue assessment, metabolic and endothelial screening', 'maximal oxygen consumption', 'recurrence and mortality rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205563', 'cui_str': 'Clinical stage finding'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4505151', 'cui_str': 'Liquid Biopsies'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",300.0,0.0642057,"Observational studies have shown that physical activity leads to reduced recurrence and mortality rates by 20-40% in colorectal, breast, and prostate cancer.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Falz', 'Affiliation': 'Institute of Sport Medicine and Prevention, University Leipzig, Marschnerstraße 29a, 04109, Leipzig, Germany. roberto.falz@uni-leipzig.de.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Thieme', 'Affiliation': 'Department of Visceral, Transplant, Thoracic and Vascular Surgery, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Tegtbur', 'Affiliation': 'Institute of Sport Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Bischoff', 'Affiliation': 'Institute of Sport Medicine and Prevention, University Leipzig, Marschnerstraße 29a, 04109, Leipzig, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Leps', 'Affiliation': 'Institute of Sport Medicine and Prevention, University Leipzig, Marschnerstraße 29a, 04109, Leipzig, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillemanns', 'Affiliation': 'Department of Gynecology and Obstetrics, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Kohlhaw', 'Affiliation': 'Department of Surgery, Sana Hospitals ""Leipziger Land"", Borna, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Klempnauer', 'Affiliation': 'Department of General, Visceral and Transplant Surgery, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Lordick', 'Affiliation': 'Department of Oncology, Gastroenterology, Hepatology, Pulmonology and Infectious Diseases, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Jens-Uwe', 'Initials': 'JU', 'LastName': 'Stolzenburg', 'Affiliation': 'Department of Urology, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Bahriye', 'Initials': 'B', 'LastName': 'Aktas', 'Affiliation': 'Department of Gynaecology, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Weitz', 'Affiliation': 'Department of Visceral-, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Bork', 'Affiliation': 'Department of Visceral-, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Wimberger', 'Affiliation': 'National Center for Tumor Diseases (NCT), Partner site Dresden, Dresden, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Thomas', 'Affiliation': 'National Center for Tumor Diseases (NCT), Partner site Dresden, Dresden, Germany.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Biemann', 'Affiliation': 'Institute of Laboratory Medicine, Clinical Chemistry and Molecular Diagnostics, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Jansen-Winkeln', 'Affiliation': 'Department of Visceral, Transplant, Thoracic and Vascular Surgery, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Antina', 'Initials': 'A', 'LastName': 'Schulze', 'Affiliation': 'Institute of Sport Medicine and Prevention, University Leipzig, Marschnerstraße 29a, 04109, Leipzig, Germany.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Gockel', 'Affiliation': 'Department of Visceral, Transplant, Thoracic and Vascular Surgery, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Busse', 'Affiliation': 'Institute of Sport Medicine and Prevention, University Leipzig, Marschnerstraße 29a, 04109, Leipzig, Germany.'}]","BMC sports science, medicine & rehabilitation",['10.1186/s13102-021-00244-w'] 2265,33626326,Topical Oxygen Jet Therapy (TOJT) for treating infected chronic surgical wounds.,"OBJECTIVES To evaluate the effectiveness of Topical Oxygen Jet Therapy (TOJT) in the treatment of surgical wounds in adult patients who has clinical signs of infection for over 30 days; and to identify the pathogens causing complicated skin and soft tissue infections. METHOD Parallel, randomized clinical trials randomly divided into ""Control Group"" (CG) and ""Treatment Group"" (TG), which were followed up for 10 consecutive days. Venous antibiotics and dressings were used in both groups. In addition, TOJT were used on the wounds in the TG. The outcome criteria were based on clinical indicators: Pressure Ulcer Scale for Healing (PUSH) and Visual Analog Scale Pain (VAS). The paired t-test or Wilcoxon, chi-squared or Fisher's exact test, and Student's t-test or Mann-Whitney tests were used with a significance level of 5%. RESULTS 73 inpatients were included and followed up: 39 in TG and 34, CG. There were no significant differences in socio-demographic variables or of initial laboratory tests, except for blood glucose that was higher in TG than in CG (p = 0.044). Ten days into treatment, both the area of PUSH wounds (p < 0.001) and the pain scale (p = 0.029) were significantly reduced in TG. Staphylococcus aureus was the most prevalent pathogen (40%) with no significant difference between the two groups. DISCUSSION Although the follow-up time was of only ten days, a significant improvement was observed in TG. As a limitation of the study, the small sample size precluded the comparison of S. aureus infections between the two groups. CONCLUSION TOJT accelerated the healing process, reduced pain and contributed to an improvement in the clinical status of the wounds when compared to CG. These findings demonstrate the effectiveness and relevance of the employed technique. It can be easily incorporated as a routine procedure in hospitals without extra investment.",2021,"Ten days into treatment, both the area of PUSH wounds (p < 0.001) and the pain scale (p = 0.029) were significantly reduced in TG.","['73 inpatients were included and followed up: 39 in TG and 34, CG', 'surgical wounds in adult patients who has clinical signs of infection for over 30 days', 'treating infected chronic surgical wounds']","['Topical Oxygen Jet Therapy (TOJT', 'Control Group"" (CG) and ""Treatment Group"" (TG']","['pain scale', 'clinical indicators: Pressure Ulcer Scale for Healing (PUSH) and Visual Analog Scale Pain (VAS', 'socio-demographic variables or of initial laboratory tests, except for blood glucose', 'TG', 'healing process, reduced pain']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332803', 'cui_str': 'Surgical wound'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0336862', 'cui_str': 'Jet airplane'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0011127', 'cui_str': 'Pressure ulcer'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0332300', 'cui_str': 'Except for'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",73.0,0.019121,"Ten days into treatment, both the area of PUSH wounds (p < 0.001) and the pain scale (p = 0.029) were significantly reduced in TG.","[{'ForeName': 'Maria Helena', 'Initials': 'MH', 'LastName': 'Otaviano', 'Affiliation': 'Faculdade de Ciências Medicas da Santa Casa de São Paulo, São Paulo, SP, Brazil. Electronic address: mariahelena1957@hotmail.com.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Salles', 'Affiliation': 'Faculdade de Ciências Medicas da Santa Casa de São Paulo, São Paulo, SP, Brazil. Electronic address: salles.infecto@gmail.com.'}, {'ForeName': 'Ting Hui', 'Initials': 'TH', 'LastName': 'Ching', 'Affiliation': 'Faculdade de Ciências Medicas da Santa Casa de São Paulo, São Paulo, SP, Brazil. Electronic address: jthc8720@gmail.com.'}, {'ForeName': 'Josilene Lopes', 'Initials': 'JL', 'LastName': 'Dettoni', 'Affiliation': 'Universidade Federal de Rondônia, Porto Velho, RO, Brazil. Electronic address: josilenedettoni@gmail.com.'}, {'ForeName': 'Ieda Guedes Simões', 'Initials': 'IGS', 'LastName': 'Coulibaly', 'Affiliation': 'EBRAMEC - Escola Brasileira de Medicina Chinesa, São Paulo, SP, Brazil. Electronic address: ieda9182@gmail.com.'}, {'ForeName': 'Erika Tiemi', 'Initials': 'ET', 'LastName': 'Fukunaga', 'Affiliation': 'Faculdade de Ciências Medicas da Santa Casa de São Paulo, São Paulo, SP, Brazil. Electronic address: erika.fukunaga@gmail.com.'}, {'ForeName': 'Mônica Antar', 'Initials': 'MA', 'LastName': 'Gamba', 'Affiliation': 'Universidade Federal de São Paulo, São Paulo, SP, Brazil. Electronic address: antar.gamba@unifesp.com.'}, {'ForeName': 'José Cássio de', 'Initials': 'JC', 'LastName': 'Moraes', 'Affiliation': 'Faculdade de Ciências Medicas da Santa Casa de São Paulo, São Paulo, SP, Brazil. Electronic address: jcassiom@uol.com.br.'}]",The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious Diseases,['10.1016/j.bjid.2021.101547'] 2266,33630447,"Robotic versus Laparoscopic Ventral Hernia Repair: One-year Results from a Prospective, Multicenter, Blinded Randomized Controlled Trial.","OBJECTIVE The aim of this study was to compare clinical and patient-reported outcomes of robotic versus laparoscopic ventral hernia repair (LVHR) at one-year post-operative. SUMMARY BACKGROUND DATA Despite a relative lack of research at low risk for bias assessing robotic ventral hernia repair (RVHR), the growth of RVHR has been rapid. We previously reported short-term results of the first randomized control trial (RCT) comparing RVHR versus LVHR; there was no clear difference in clinical outcomes but increased operative time and cost with robotic repair. METHODS Patients from a multicenter, blinded RCT comparing RVHR versus LVHR were followed at one year. Outcomes included wound complication (surgical site infection, surgical site occurrence, wound dehiscence), hernia occurrence including recurrence and port site hernia, readmission, reoperation, and patient-reported outcomes (functional status, pain, and satisfaction with repair and cosmesis). RESULTS A total of 124 patients were randomized and 113 patients (91%; 60 robot, 53 laparoscopic) completed one-year follow-up. Baseline demographics were similar in both groups. No differences were seen in wound complication (15% vs 15%; p = 0.899), hernia recurrence (7% vs 9%; p = 0.576), or readmission (2% vs 6%; p = 0.251). No patients underwent reoperation in the robotic arm, whereas five (9%) did in the laparoscopic arm (p = 0.020). No differences were seen in patient-reported outcomes. Both arms reported clinically significant improvements in functional status, low pain scores and high satisfaction scores at one-year post repair. CONCLUSION This study confirms that robotic ventral hernia repair is safe when compared to laparoscopy. Further studies are needed to confirm these findings.",2021,"Both arms reported clinically significant improvements in functional status, low pain scores and high satisfaction scores at one-year post repair. ","['124 patients were randomized and 113 patients (91%; 60 robot, 53 laparoscopic) completed one-year follow-up', 'Patients from a multicenter, blinded']","['Robotic versus Laparoscopic Ventral Hernia Repair', 'robotic versus laparoscopic ventral hernia repair (LVHR', 'RCT comparing RVHR versus LVHR', 'robotic ventral hernia repair']","['readmission', 'functional status, low pain scores and high satisfaction scores', 'wound complication', 'hernia recurrence', 'operative time and cost with robotic repair', 'wound complication (surgical site infection, surgical site occurrence, wound dehiscence), hernia occurrence including recurrence and port site hernia, readmission, reoperation, and patient-reported outcomes (functional status, pain, and satisfaction with repair and cosmesis']","[{'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0019334', 'cui_str': 'Repair of ventral hernia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0332850', 'cui_str': 'Operative site'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0259768', 'cui_str': 'Wound dehiscence'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",124.0,0.369011,"Both arms reported clinically significant improvements in functional status, low pain scores and high satisfaction scores at one-year post repair. ","[{'ForeName': 'Naila H', 'Initials': 'NH', 'LastName': 'Dhanani', 'Affiliation': '*Department of Surgery, McGovern Medical School at UTHealth, Houston, TX †Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston TX.'}, {'ForeName': 'Oscar A', 'Initials': 'OA', 'LastName': 'Olavarria', 'Affiliation': ''}, {'ForeName': 'Julie L', 'Initials': 'JL', 'LastName': 'Holihan', 'Affiliation': ''}, {'ForeName': 'Shinil K', 'Initials': 'SK', 'LastName': 'Shah', 'Affiliation': ''}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Wilson', 'Affiliation': ''}, {'ForeName': 'Michele M', 'Initials': 'MM', 'LastName': 'Loor', 'Affiliation': ''}, {'ForeName': 'Tien C', 'Initials': 'TC', 'LastName': 'Ko', 'Affiliation': ''}, {'ForeName': 'Lillian S', 'Initials': 'LS', 'LastName': 'Kao', 'Affiliation': ''}, {'ForeName': 'Mike K', 'Initials': 'MK', 'LastName': 'Liang', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004795'] 2267,33630435,Estimating the Impact of Extended Delay to Surgery for Stage I Non-small-cell Lung Cancer on Survival.,"OBJECTIVE The purpose of this study is to evaluate the impact of extended delay to surgery for stage I NSCLC. SUMMARY OF BACKGROUND DATA During the COVID-19 pandemic, patients with NSCLC may experience delays in care, and some national guidelines recommend delays in surgery by >3 months for early NSCLC. METHODS Using data from the National Lung Screening Trial, a multi-center randomized trial, and the National Cancer Data Base, a multi-institutional oncology registry, the impact of ""early"" versus ""delayed"" surgery (surgery received 0-30 vs 90-120 days after diagnosis) for stage I lung adenocarcinoma and squamous cell carcinoma (SCC) was assessed using multivariable Cox regression analysis with penalized smoothing spline functions and propensity score-matched analyses. RESULTS In Cox regression analysis of the National Lung Screening Trial (n = 452) and National Cancer Data Base (n = 80,086) cohorts, an increase in the hazard ratio was seen the longer surgery was delayed. In propensity score-matched analysis, no significant differences in survival were found between early and delayed surgery for stage IA1 adenocarcinoma and IA1-IA3 SCC (all P > 0.13). For stage IA2-IB adenocarcinoma and IB SCC, delayed surgery was associated with worse survival (all P < 0.004). CONCLUSIONS The mortality risk associated with an extended delay to surgery differs across patient subgroups, and difficult decisions to delay care during the COVID-19 pandemic should take substage and histologic subtype into consideration.",2021,"In propensity score-matched analysis, no differences in survival were found between early and delayed surgery for stage IA1 adenocarcinoma and IA1-IA3 squamous cell carcinoma (all P > 0.13).",['For stage IA1 adenocarcinoma and IA squamous cell carcinoma'],['NLST'],"['survival', 'mortality risk', 'hazard ratio (HR', 'worse survival', 'stage IA1 adenocarcinoma and IA1-IA3 squamous cell carcinoma']","[{'cui': 'C0458828', 'cui_str': 'Stage 1A1'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}]","[{'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0458828', 'cui_str': 'Stage 1A1'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}]",,0.168728,"In propensity score-matched analysis, no differences in survival were found between early and delayed surgery for stage IA1 adenocarcinoma and IA1-IA3 squamous cell carcinoma (all P > 0.13).","[{'ForeName': 'Nicholas R', 'Initials': 'NR', 'LastName': 'Mayne', 'Affiliation': 'Department of Surgery, Duke University, Durham, North Carolina.'}, {'ForeName': 'Holly C', 'Initials': 'HC', 'LastName': 'Elser', 'Affiliation': 'Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Alice J', 'Initials': 'AJ', 'LastName': 'Darling', 'Affiliation': 'Department of Surgery, Duke University, Durham, North Carolina.'}, {'ForeName': 'Vignesh', 'Initials': 'V', 'LastName': 'Raman', 'Affiliation': 'Department of Surgery, Duke University, Durham, North Carolina.'}, {'ForeName': 'Douglas Z', 'Initials': 'DZ', 'LastName': 'Liou', 'Affiliation': 'Department of Cardiothoracic Surgery, Stanford University, Stanford, California.'}, {'ForeName': 'Yolonda L', 'Initials': 'YL', 'LastName': 'Colson', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': ""D'Amico"", 'Affiliation': 'Department of Surgery, Duke University, Durham, North Carolina.'}, {'ForeName': 'Chi-Fu Jeffrey', 'Initials': 'CJ', 'LastName': 'Yang', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}]",Annals of surgery,['10.1097/SLA.0000000000004811'] 2268,33629536,"Effect of Mastiha supplementation on NAFLD: The MAST4HEALTH Randomised, Controlled Trial.","SCOPE Nonalcoholic fatty liver disease (NAFLD) is the most common liver disease with poor therapeutic strategies. Mastiha possesses antioxidant/anti-inflammatory and lipid-lowering properties. The authors investigate the effectiveness of Mastiha as a nonpharmacological intervention in NAFLD. METHODS AND RESULTS Ninety-eight patients with NAFLD in three countries (Greece, Italy, Serbia) are randomly allocated to either Mastiha or Placebo for 6 months, as part of a multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial. The authors assess NAFLD severity via magnetic resonance imaging (MRI) scanning and LiverMultiScan technique and evaluate the effectiveness of Mastiha through medical, anthropometric, biochemical, metabolomic, and microbiota assessment. Mastiha is not superior to Placebo on changes in iron-corrected T1 (cT1) and Liver Inflammation Fibrosis score (LIF) in entire patient population; however, after BMI stratification (BMI ≤ 35 kg m -2 and BMI > 35 kg m -2 ), severely obese patients show an improvement in cT1 and LIF in Mastiha versus Placebo. Mastiha increases dissimilarity of gut microbiota, as shown by the Bray-Curtis index, downregulates Flavonifractor, a known inflammatory taxon and decreases Lysophosphatidylcholines-(LysoPC) 18:1, Lysophosphatidylethanolamines-(LysoPE) 18:1, and cholic acid compared to Placebo. CONCLUSION Mastiha supplementation improves microbiota dysbiosis and lipid metabolite levels in patients with NAFLD, although it reduces parameters of liver inflammation/fibrosis only in severely obese patients.",2021,"Mastiha was not superior to Placebo on changes in iron-corrected T1 (cT1) and Liver Inflammation Fibrosis score (LIF) in entire patient population; however, after BMI stratification (BMI≤ 35 kg/m 2 and BMI> 35 kg/m 2 ) severely obese patients showed improvement in cT1 and LIF in Mastiha versus Placebo.","['NAFLD', 'severely obese patients', '98 patients with NAFLD in three countries (Greece, Italy, Serbia', 'patients with NAFLD']","['placebo', 'cholic acid', 'Mastiha or Placebo', 'Mastiha supplementation', 'Lysophosphatidylethanolamines-(LysoPE', 'Magnetic Resonance Imaging (MRI) scanning and LiverMultiScan technique', 'Placebo']","['cT1 and LIF', 'microbiota dysbiosis and lipid metabolite levels', 'changes in iron-corrected T1 (cT1) and Liver Inflammation Fibrosis score (LIF', 'Lysophosphatidylcholines-(LysoPC', 'Mastiha increased dissimilarity of gut microbiota']","[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0036708', 'cui_str': 'Republic of Serbia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008404', 'cui_str': 'Cholalic Acids'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0065389', 'cui_str': 'lysophosphatidylethanolamine'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0019158', 'cui_str': 'Inflammatory disease of liver'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C3658208', 'cui_str': 'Dysbiosis'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0024360', 'cui_str': 'Lysolecithin'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]",98.0,0.548088,"Mastiha was not superior to Placebo on changes in iron-corrected T1 (cT1) and Liver Inflammation Fibrosis score (LIF) in entire patient population; however, after BMI stratification (BMI≤ 35 kg/m 2 and BMI> 35 kg/m 2 ) severely obese patients showed improvement in cT1 and LIF in Mastiha versus Placebo.","[{'ForeName': 'Charalampia', 'Initials': 'C', 'LastName': 'Amerikanou', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, Athens, Greece.'}, {'ForeName': 'Stavroula', 'Initials': 'S', 'LastName': 'Kanoni', 'Affiliation': 'William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, EC1M 6BQ, UK.'}, {'ForeName': 'Andriana C', 'Initials': 'AC', 'LastName': 'Kaliora', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, Athens, Greece.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Barone', 'Affiliation': 'Perspectum Ltd, Oxford, UK.'}, {'ForeName': 'Mladen', 'Initials': 'M', 'LastName': 'Bjelan', 'Affiliation': 'Faculty of Medicine, University of Novi Sad, Novi Sad, Serbia.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': ""D'Auria"", 'Affiliation': 'Sequencing and Bioinformatics Service, Fundació per al Foment de la Investigació Sanitària i Biomèdica de la Comunitat Valenciana (FISABIO-Salut Pública), Avda. Catalunya 21, València, 46020, Spain.'}, {'ForeName': 'Aristea', 'Initials': 'A', 'LastName': 'Gioxari', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, Athens, Greece.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Gosalbes', 'Affiliation': 'CIBER en Epidemiología y Salud Pública, Av. Monforte de Lemos 3-5, Madrid, 28029, Spain.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Mouchti', 'Affiliation': 'Perspectum Ltd, Oxford, UK.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Stathopoulou', 'Affiliation': 'UMR INSERM U1122; IGE-PCV, University of Loraine, Nancy, France.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Soriano', 'Affiliation': 'Biotechvana, Parc Científic, Universitat de València, Paterna, Valencia, Spain.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Stojanoski', 'Affiliation': 'Faculty of Medicine, University of Novi Sad, Novi Sad, Serbia.'}, {'ForeName': 'Rajarshi', 'Initials': 'R', 'LastName': 'Banerjee', 'Affiliation': 'Perspectum Ltd, Oxford, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Halabalaki', 'Affiliation': 'Division of Pharmacognosy and Natural Products Chemistry, Department of Pharmacy, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Eleni V', 'Initials': 'EV', 'LastName': 'Mikropoulou', 'Affiliation': 'Division of Pharmacognosy and Natural Products Chemistry, Department of Pharmacy, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Aimo', 'Initials': 'A', 'LastName': 'Kannt', 'Affiliation': 'Sanofi Research and Development, Industriepark Hoechst, Frankfurt, 65926, Germany.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lamont', 'Affiliation': 'Randox Laboratories Limited, Crumlin, Co. Antrim, Northern Ireland, UK.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Llorens', 'Affiliation': 'Biotechvana, Parc Científic, Universitat de València, Paterna, Valencia, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Marascio', 'Affiliation': 'Marascio Fernando, Intervideo, Catanzaro, CZ, 88100, Italy.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Marascio', 'Affiliation': 'Marascio Fernando, Intervideo, Catanzaro, CZ, 88100, Italy.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Roig', 'Affiliation': 'Biotechvana, Parc Científic, Universitat de València, Paterna, Valencia, Spain.'}, {'ForeName': 'Ilias', 'Initials': 'I', 'LastName': 'Smyrnioudis', 'Affiliation': 'Chios Mastic Gum Growers Association, Chios, Greece.'}, {'ForeName': 'Iraklis', 'Initials': 'I', 'LastName': 'Varlamis', 'Affiliation': 'Department of Informatics and Telematics, Harokopio University, Athens, Greece.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Visvikis-Siest', 'Affiliation': 'UMR INSERM U1122; IGE-PCV, University of Loraine, Nancy, France.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Vukic', 'Affiliation': 'Department of Food Technology, Faculty of Technology Zvornik, University of East Sarajevo, Zvornik, 75400, Bosnia and Herzegovina.'}, {'ForeName': 'Natasa', 'Initials': 'N', 'LastName': 'Milic', 'Affiliation': 'Faculty of Medicine, University of Novi Sad, Novi Sad, Serbia.'}, {'ForeName': 'Milica', 'Initials': 'M', 'LastName': 'Medic-Stojanoska', 'Affiliation': 'Faculty of Medicine, University of Novi Sad, Novi Sad, Serbia.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Cesarini', 'Affiliation': ""Division of Hepatology and Gastroenterology, Niguarda Ca' Grande Hospital Milan, Italy.""}, {'ForeName': 'Jonica', 'Initials': 'J', 'LastName': 'Campolo', 'Affiliation': 'Institute of Clinical Physiology, CNR, Milan, Italy.'}, {'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Gastaldelli', 'Affiliation': 'Cardiometabolic Risk Unit, Institute of Clinical Physiology, CNR, Pisa, Italy.'}, {'ForeName': 'Panos', 'Initials': 'P', 'LastName': 'Deloukas', 'Affiliation': 'William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, EC1M 6BQ, UK.'}, {'ForeName': 'Maria Giovanna', 'Initials': 'MG', 'LastName': 'Trivella', 'Affiliation': 'Institute of Clinical Physiology, CNR, Milan, Italy.'}, {'ForeName': 'M Pilar', 'Initials': 'MP', 'LastName': 'Francino', 'Affiliation': 'CIBER en Epidemiología y Salud Pública, Av. Monforte de Lemos 3-5, Madrid, 28029, Spain.'}, {'ForeName': 'George V', 'Initials': 'GV', 'LastName': 'Dedoussis', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, Athens, Greece.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Molecular nutrition & food research,['10.1002/mnfr.202001178'] 2269,33629524,Authors' reply re: Vaginal Er:YAG laser application in the menopausal ewe model: a randomised estrogen and sham-controlled trial.,,2021,,['menopausal ewe model'],['Vaginal Er:YAG laser application'],[],"[{'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0337831', 'cui_str': 'Ewe'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0457903', 'cui_str': 'Erbium:YAG laser device'}, {'cui': 'C0185125', 'cui_str': 'Application'}]",[],,0.18191,,"[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Mackova', 'Affiliation': 'Department of Development and Regeneration, Cluster Urogenital, Abdominal and Plastic Surgery, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Deprest', 'Affiliation': 'Department of Development and Regeneration, Cluster Urogenital, Abdominal and Plastic Surgery, KU Leuven, Leuven, Belgium.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16653'] 2270,33632327,Effects of a 90-min educational intervention for patients with insect venom allergy: a prospective controlled pilot study.,"BACKGROUND Anaphylactic sting reactions need a prompt management. A structured educational intervention for patients with insect sting allergy has not been implemented so far. The purpose of this study was to analyze the effects of a structured 90-min educational intervention for patients with insect sting allergy. METHODS Patients with an insect venom allergy were offered to participate in a structured 90-min group education (intervention group (IG)) or to attend a control group (CG). The patients' subjective self-assurance in using the emergency medication, the willingness to always carry the emergency medication, the mental health status, absolute one-time willingness-to-pay (WTP) for complete cure, a disease knowledge assessment and a simulation test to examine the ability to manage an acute sting reaction were estimated at baseline (t0) and at follow-up (t1) as outcome parameters. RESULTS 55 patients participated in the IG (n = 25, 52.0% female, mean age 55.9 years) or the CG (n = 30, 56.7% female, mean age 52.0 years). Both arms showed a significant gain in self-assurance in using the emergency medication (IG: 6.1 at t0 vs. 8.6 at t1, p < 0.0001 and CG: 7.1 vs. 8.0, p = 0.0062) and ability to manage an acute sting reaction (IG: 6.7 vs. 11.4, p < 0.0001 and CG: 9.0 vs. 10.5, p = 0.0002) at t1. However, trained participants showed a significantly higher gain in the respective parameters. There were no significant changes regarding the remaining examined outcome parameters. CONCLUSIONS Patients who are willing to invest 90 min in a patient education intervention benefit significantly by an increased subjective and objective empowerment to manage an acute sting reaction.",2021,"Both arms showed a significant gain in self-assurance in using the emergency medication (IG: 6.1 at t0 vs. 8.6 at t1, p < 0.0001 and CG: 7.1 vs. 8.0, p = 0.0062) and ability to manage an acute sting reaction (IG: 6.7 vs. 11.4, p < 0.0001 and CG: 9.0 vs. 10.5, p = 0.0002) at t1.","['patients with insect venom allergy', 'patients with insect sting allergy', 'Patients with an insect venom allergy', '55 patients participated in the IG (n\u2009=\u200925, 52.0% female, mean age 55.9\xa0years) or the CG (n\u2009=\u200930, 56.7% female, mean age 52.0\xa0years']","['90-min educational intervention', 'structured educational intervention', 'structured 90-min group education (intervention group (IG)) or to attend a control group (CG', 'structured 90-min educational intervention']","['significant gain in self-assurance', 'subjective and objective empowerment to manage an acute sting reaction', 'ability to manage an acute sting reaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0459796', 'cui_str': 'Insect venom'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0021585', 'cui_str': 'Class Insecta'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150375', 'cui_str': 'Group education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038340', 'cui_str': 'Sting'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",55.0,0.0288313,"Both arms showed a significant gain in self-assurance in using the emergency medication (IG: 6.1 at t0 vs. 8.6 at t1, p < 0.0001 and CG: 7.1 vs. 8.0, p = 0.0062) and ability to manage an acute sting reaction (IG: 6.7 vs. 11.4, p < 0.0001 and CG: 9.0 vs. 10.5, p = 0.0002) at t1.","[{'ForeName': 'Lisa-Sophie', 'Initials': 'LS', 'LastName': 'Schoeben', 'Affiliation': 'Department of Dermatology, University Medical Center Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68135, Mannheim, Germany.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Mohr', 'Affiliation': 'Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Bubak', 'Affiliation': 'Department of Dermatology, University Medical Center Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68135, Mannheim, Germany.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Schmieder', 'Affiliation': 'Department of Dermatology, University Medical Center Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68135, Mannheim, Germany.'}, {'ForeName': 'Marthe-Lisa', 'Initials': 'ML', 'LastName': 'Schaarschmidt', 'Affiliation': 'Department of Dermatology, University Medical Center Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68135, Mannheim, Germany. marthe-lisa.schaarschmidt@umm.de.'}]","Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology",['10.1186/s13223-021-00524-7'] 2271,33631541,Piloting a brief intervention plus mobile boosters for drug use among emerging adults receiving emergency department care.,"PURPOSE There are few efficacious prevention interventions for emerging adults (ages 18-25) drug use and concomitant risks (e.g., sexual risk behaviors). We developed and evaluated the feasibility and acceptability of an Emergency Department (ED)-initiated brief intervention (BI) combined with booster messaging as a clinician-extender primarily focusing on drug use, with a secondary focus on condomless sex. We examined descriptive outcomes of alcohol, drug use, and condomless sex. PROCEDURES We recruited N = 63 emerging adults who used drugs (primarily cannabis) from an ED (72.4 % participation rate). Their mean age was 21.7 years (SD = 2.3); 67 % were female and 52.4 % were Black/African American. Participants randomized to the intervention (N = 31) received a BI and 28 days of tailored booster messaging (based on drug use motives) daily, and the control condition received a community resource brochure. A post-test occurred at 1-month with a follow-up at 2-months. RESULTS The intervention was well-received (83.9 % allocated completed the BI) with 79 % overall liking the BI and 71 % finding it helpful to discuss substances. Mean ratings of booster messages were >4.0 (5-point scale); 77 % liked the daily messages and 91 % found them helpful. Descriptively, the intervention group evidenced absolute reductions over time on alcohol outcomes, cannabis use, and condomless sex. CONCLUSIONS This BI with booster messages was feasible and acceptable in the target population of emerging adults who use drugs (i.e., mostly cannabis). This intervention model, initiated during a healthcare visit and accompanied by a clinician-extender, should be tested in a future fully-powered trial.",2021,Mean ratings of booster messages were >4.0 (5-point scale); 77 % liked the daily messages and 91 % found them helpful.,"['adults receiving emergency department care', 'Their mean age was 21.7 years (SD = 2.3); 67 % were female and 52.4 % were Black/African American', 'We recruited N = 63 emerging adults who used drugs (primarily cannabis) from an ED (72.4 % participation rate']","['Emergency Department (ED)-initiated brief intervention (BI) combined with booster messaging', 'BI and 28 days of tailored booster messaging (based on drug use motives) daily, and the control condition received a community resource brochure']","['absolute reductions over time on alcohol outcomes, cannabis use, and condomless sex', 'Mean ratings of booster messages']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}]","[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}]",63.0,0.0467803,Mean ratings of booster messages were >4.0 (5-point scale); 77 % liked the daily messages and 91 % found them helpful.,"[{'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Bonar', 'Affiliation': 'Addiction Center, Department of Psychiatry, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 16, Ann Arbor, MI, 48109, USA; Injury Prevention Center, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 10, Ann Arbor, MI, 48109, USA; Center for Sexuality and Health Disparities, University of Michigan, 400 North Ingalls Street, Ann Arbor, MI, 48109, USA. Electronic address: erinbona@med.umich.edu.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Cunningham', 'Affiliation': 'Injury Prevention Center, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 10, Ann Arbor, MI, 48109, USA; Department of Emergency Medicine, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 10, Ann Arbor, MI, 48109, USA; Department of Health Behavior and Health Education, School of Public Health, University of Michigan, 1415 Washington Heights, Ann Arbor, MI, 48109, USA; Emergency Medicine, Hurley Medical Center, 1 Hurley Plaza, Flint, MI, 48503, USA.'}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Sweezea', 'Affiliation': 'Addiction Center, Department of Psychiatry, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 16, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Frederic C', 'Initials': 'FC', 'LastName': 'Blow', 'Affiliation': 'Addiction Center, Department of Psychiatry, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 16, Ann Arbor, MI, 48109, USA; VA Center for Clinical Management Research, North Campus Research Complex, 2800 Plymouth Rd Bldg 16, Ann Arbor, MI, 48109-2800, USA.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Drislane', 'Affiliation': 'Addiction Center, Department of Psychiatry, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 16, Ann Arbor, MI, 48109, USA; Department of Psychology and Philosophy, Sam Houston State University, 1901 Avenue I, Huntsville, TX, 77340, USA.'}, {'ForeName': 'Maureen A', 'Initials': 'MA', 'LastName': 'Walton', 'Affiliation': 'Addiction Center, Department of Psychiatry, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 16, Ann Arbor, MI, 48109, USA; Injury Prevention Center, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 10, Ann Arbor, MI, 48109, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.108625'] 2272,33639478,Impact of age on the comparison between short-term vs 12-month dual antiplatelet therapy in patients with acute coronary syndrome treated with the COMBO dual therapy stent: 2-Year follow-up results of the REDUCE trial.,"BACKGROUND AND AIMS The impact of advanced age on the optimal duration of dual antiplatelet therapy (DAPT) in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary revascularization (PCI) is still greatly debated. Therefore, the aim of the present sub-analysis of the REDUCE trial was to assess the impact of age on the comparison between a short 3 months vs standard 12 months DAPT in ACS patients treated with the COMBO Dual Stent Therapy. METHODS The REDUCE trial is a prospective, multicenter, investigator-initiated study that randomized ACS patients undergoing PCI with the COMBO drug eluting stent to either 3 or 12 months of DAPT. The study population was divided according to age ( 0.05). CONCLUSION Auricular point acupressure accelerates corneal epithelium reconstruction and suppresses postoperative pain, making it an ideal adjunct treatment for postoperative pterygium recovery. CLINICAL TRIAL REGISTRATION NUMBER ChiCTR2000032490 on http://www.chictr.org.cn/.",2021,Mean corneal epithelial scores of the auricular group were significantly lower on the first day and third day respectively than the control group (p < 0.05).,"['60 patients (60 eyes', 'Fifty-three patients completed the study', 'patients after pterygium surgery']","['auricular point acupressure', 'ear acupressure (acupressure points with Cowherb seeds) and the control group was treated using sham auricular therapy (acupressure points without Cowherb seeds', 'Auricular point acupressure', 'auricular point acupressure treatment']","['Mean corneal epithelial scores', 'pain scores and corneal epithelial scores', 'mean pain scores and corneal epithelial scores', 'pain score, corneal epithelial score, best-corrected visual acuity, and recurrence rate', 'mean pain scores', 'best-corrected visual acuity or recurrence rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",60.0,0.0907746,Mean corneal epithelial scores of the auricular group were significantly lower on the first day and third day respectively than the control group (p < 0.05).,"[{'ForeName': 'Lusha', 'Initials': 'L', 'LastName': 'Cen', 'Affiliation': 'Department of Ophthalmology, The First Affiliated Hospital of Zhejiang Chinese Medical University, Youdian Rd.54th, Hangzhou, 310006, China. Electronic address: 201811010712026@zcmu.edu.cn.'}, {'ForeName': 'Cao', 'Initials': 'C', 'LastName': 'Yi', 'Affiliation': 'Department of Dermatology, The First Affiliated Hospital of Zhejiang Chinese Medical University, China. Electronic address: 19873034@zcmu.edu.cn.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101339'] 2278,33638741,Removal of cement-augmented screws in distal femoral fractures and the effect of retained screws and cement on total knee arthroplasty: a biomechanical investigation.,"BACKGROUND Given the increasing number of osteoporotic fractures of the distal femur, screw augmentation with bone cement is an option to enhance implant anchorage. However, in implant removal or revision surgeries, the cement cannot be removed from the distal femur without an extended surgical procedure. Therefore, the aims of this study were to investigate (1) whether cement augmentation has any influence on screw removal and removal torque, and (2) whether the implantation of a femoral component of a knee arthroplasty and its initial interface stability are affected by the remaining screws/cement. MATERIAL AND METHODS Eight pairs of fresh-frozen human female cadaveric distal femurs (mean age, 86 years) with a simulated AO/OTA 33 A3 fracture were randomized in paired fashion to two groups and fixed with a distal femoral locking plate using cannulated perforated locking screws. Screw augmentation with bone cement was performed in one of the groups, while the other group received no screw augmentation. Following biomechanical testing until failure (results published separately), the screws were removed and the removal torque was measured. A femoral component of a knee arthroplasty was then implanted, and pull-out tests were performed after cement curing. Interference from broken screws/cement was assessed, and the maximum pull-out force was measured. RESULTS The mean screw removal torque was not significantly different between the augmented (4.9 Nm, SD 0.9) and nonaugmented (4.6 Nm, SD 1.3, p = 0.65) screw groups. However, there were significantly more broken screws in in the augmented screw group (17 versus 9; p < 0.001). There was no significant difference in the pull-out force of the femoral component between the augmented (2625 N, SD 603) and nonaugmented (2653 N, SD 542, p = 0.94) screw groups. CONCLUSION The screw removal torque during implant removal surgery does not significantly differ between augmented and nonaugmented screws. In the augmented screw group, significantly more screws failed. To overcome this, the use of solid screws in holes B, C, and G can be considered. Additionally, it is possible to implant a femoral component for knee arthroplasty that retains the initial anchorage and does not suffer from interference with broken screws and/or residual cement. LEVEL OF EVIDENCE 5.",2021,"The mean screw removal torque was not significantly different between the augmented (4.9 Nm, SD 0.9) and nonaugmented (4.6 Nm, SD 1.3, p = 0.65) screw groups.","['total knee arthroplasty', 'Eight pairs of fresh-frozen human female cadaveric distal femurs (mean age, 86\xa0years) with a simulated AO/OTA 33 A3 fracture']","['retained screws and cement', 'Screw augmentation with bone cement', 'distal femoral locking plate using cannulated perforated locking screws', 'no screw augmentation', 'Removal of cement-augmented screws']","['pull-out force of the femoral component', 'screw removal torque', 'mean screw removal torque', 'broken screws']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0069299', 'cui_str': 'ochratoxin A'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0005934', 'cui_str': 'Bone cements'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]","[{'cui': 'C0580846', 'cui_str': 'Does pull'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0449434', 'cui_str': 'Femoral component'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0502287,"The mean screw removal torque was not significantly different between the augmented (4.9 Nm, SD 0.9) and nonaugmented (4.6 Nm, SD 1.3, p = 0.65) screw groups.","[{'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Wähnert', 'Affiliation': 'Department of Trauma and Orthopedic Surgery, Protestant Hospital of Bethel Foundation, University Hospital OWL of Bielefeld University, Campus Bielefeld-Bethel, Burgsteig 13, 33617, Bielefeld, Germany. Dirk.Waehnert@evkb.de.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Grüneweller', 'Affiliation': 'Department of Trauma and Orthopedic Surgery, Protestant Hospital of Bethel Foundation, University Hospital OWL of Bielefeld University, Campus Bielefeld-Bethel, Burgsteig 13, 33617, Bielefeld, Germany.'}, {'ForeName': 'Boyko', 'Initials': 'B', 'LastName': 'Gueorguiev', 'Affiliation': 'AO Research Institute Davos, Clavadelerstrasse 8, 7270, Davos, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Vordemvenne', 'Affiliation': 'Department of Trauma and Orthopedic Surgery, Protestant Hospital of Bethel Foundation, University Hospital OWL of Bielefeld University, Campus Bielefeld-Bethel, Burgsteig 13, 33617, Bielefeld, Germany.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Gehweiler', 'Affiliation': 'AO Research Institute Davos, Clavadelerstrasse 8, 7270, Davos, Switzerland.'}]",Journal of orthopaedics and traumatology : official journal of the Italian Society of Orthopaedics and Traumatology,['10.1186/s10195-021-00568-w'] 2279,33646365,Clinical efficacy and implementation issues of an electronic pain reporting device among outpatients with cancer.,"PURPOSE Collecting patients' pain features for congruent pain relief treatment is time-consuming. We sought to identify implementation issues and evaluate the efficacy of an electronic patient self-reporting pain device in community-based cancer clinics. METHODS In a 2-phase descriptive pilot and randomized controlled trial (RCT) with pretest/posttest design, 178 cancer patients participated (n = 33 pilot phase; n = 145 in the RCT phase). Patients completed PAINReportIt®, an electronic version of the valid and reliable McGill Pain Questionnaire that comprehensively measures the multiple dimensions of pain. All pilot phase and RCT patients were asked to complete PAINReportIt® twice and received usual care. For RCT patients assigned to the experimental group, a copy of the PAINReportIt® Summary was placed in their clinic medical record before they visited their clinicians. Posttest measures were completed 3-7 days later. RESULTS We identified three implementation barriers: system resistance to deposit of research data into the medical record, staff resistance to change, and patients' physical manipulation of the tablet. The time required to complete the tool did not differ significantly between groups but reduced significantly pre- to posttest in both RCT groups. Current pain intensity and pain quality but not worst pain scores decreased significantly pre- to posttest in the experimental group. None of the pain variables differed significantly between groups. CONCLUSION Implementation of PAINReportIt® was feasible in community oncology clinic settings. Barriers identified were expected and were surmountable. The studied tool showed satisfactory time sparing for comprehensive pain assessment with data automatically recorded and easily accessed by the clinician in the form of a summary report. Findings support the need for additional research to demonstrate the clinical efficacy of tablet-based pain assessment on patient outcomes as well as clinical care processes such as pain documentation and analgesic prescriptions.",2021,The time required to complete the tool did not differ significantly between groups but reduced significantly pre- to posttest in both RCT groups.,"['178 cancer patients participated (n = 33 pilot phase; n = 145 in the RCT phase', 'outpatients with cancer', 'community-based cancer clinics']","['electronic pain reporting device', 'electronic patient self-reporting pain device']","['pain variables', 'Current pain intensity and pain quality', 'pain scores', 'time required to complete the tool']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]",178.0,0.0527144,The time required to complete the tool did not differ significantly between groups but reduced significantly pre- to posttest in both RCT groups.,"[{'ForeName': 'M Kay M', 'Initials': 'MKM', 'LastName': 'Judge', 'Affiliation': 'Nursing Consult LLC, 2125 First Ave #1802, Seattle, WA, 98121, USA. nursingconsultllc@gmail.com.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Luedke', 'Affiliation': 'Nursing Consult LLC, 2125 First Ave #1802, Seattle, WA, 98121, USA.'}, {'ForeName': 'Brenda W', 'Initials': 'BW', 'LastName': 'Dyal', 'Affiliation': 'Department of Biobehavioral Nursing Science, College of Nursing, University of Florida, 1225 Center Drive, Room 2203, Gainesville, FL, 32610, USA.'}, {'ForeName': 'Miriam O', 'Initials': 'MO', 'LastName': 'Ezenwa', 'Affiliation': 'Department of Biobehavioral Nursing Science, College of Nursing, University of Florida, 1225 Center Drive, Room 2203, Gainesville, FL, 32610, USA.'}, {'ForeName': 'Diana J', 'Initials': 'DJ', 'LastName': 'Wilkie', 'Affiliation': 'eNURSING LLC, 1138 E 5645th S, Salt Lake City, UT, 84121-1011, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-021-06075-2'] 2280,33621815,Evaluation of a self-management intervention for adults with epilepsy in Taiwan: A longitudinal randomized controlled trial.,"PURPOSE Epilepsy is a neurological disease that causes recurrent seizures and can have a significant impact on a person's quality of life (QOL). A self-management intervention (SMI) can allow adults with epilepsy to modify behaviors in order to manage their seizures and evaluate the impact of medication and treatments on their daily lives. The purpose of this study was to investigate the effects of a SMI for adults with epilepsy. METHODS This was a longitudinal randomized controlled trial. Adults with epilepsy between the age of 20 and 65 years were recruited from a medical center in northern Taiwan. Participants were assigned to an intervention group (IG) or control group (CG) through simple randomization. Data regarding demographic and clinical characteristics were collected at baseline (T0). In addition, participants answered nine validated self-report questionnaires, which were used as outcome measures. Following collection of baseline data, the CG received routine monthly counseling over the next 3 months. The IG received the routine monthly counseling, as well as individual face-to-face health counseling on self-management 1 h/month and remote counseling via the phone or computer network at least twice per month. After the first month (T1) and at the end of the third (T2) and sixth months (T3) participants answered the nine questionnaires again. Differences in outcomes between the IGs and CGs were analyzed by comparing scores for the nine outcome variables at T0 with scores at T1, T2, and T3 with generalized estimating equations. RESULTS A total of 210 adults agreed to participate in the study; however, only 155 participants completed the questionnaires for all three time points: 75 in the CG and 80 in the IG. The mean age of the 155 participants was 39.6 years (SD = 10.9). There was no significant difference between demographic or clinical variables between the two groups. The only difference in baseline scores (T0) among the nine self-report questionnaires was in epilepsy knowledge, measured with the Epilepsy Knowledge Profile questionnaire, which were significantly higher for the CG (mean = 32.28, SD = 3.92) than the IG (mean = 23.01, SD = 2.79) (p < 0.001). Generalized estimating equations (GEE) analysis showed scores decreased significantly at T3 from baseline for the CG for epilepsy knowledge and QOL (p < 0.001). Improvements in scores for sleep quality, anxiety, depression, self-efficacy, coping, and social support did not differ between groups. Classification of the IG by gender showed a significantly greater increase for males compared with females from baseline to T3 for epilepsy knowledge (p < 0.001). If we further classified the IGs by seizure frequency, participants with a seizure frequency of ≥1 per year had a more significant increase in epilepsy knowledge and increase in QOL compared with participants with a seizure frequency of <1 per year at T3 compared with T0. CONCLUSION The lack of improvement in health-related quality of life (HRQoL) following the SMI may indicate that additional time is required to change behaviors that impact this variable for patients with epilepsy. Additional research should focus on variables associated with medication compliance, epilepsy knowledge, medicine symptom distress, self-efficacy, anxiety, and HRQoL.",2021,"Improvements in scores for sleep quality, anxiety, depression, self-efficacy, coping, and social support did not differ between groups.","['The mean age of the 155 participants was 39.6\u202fyears (SD\u202f=\u202f10.9', '210 adults agreed to participate in the study; however, only 155 participants completed the questionnaires for all three time points: 75 in the CG and 80 in the IG', 'patients with epilepsy', 'Adults with epilepsy between the age of 20 and 65\u202fyears were recruited from a medical center in northern Taiwan', 'adults with epilepsy in Taiwan', 'adults with epilepsy']","['SMI', 'self-management intervention (SMI', 'routine monthly counseling, as well as individual face-to-face health counseling on self-management 1\u202fh/month and remote counseling via the phone or computer network at least twice per month', 'intervention group (IG) or control group (CG', 'self-management intervention']","['sleep quality, anxiety, depression, self-efficacy, coping, and social support', 'health-related quality of life (HRQoL', 'medication compliance, epilepsy knowledge, medicine symptom distress, self-efficacy, anxiety, and HRQoL', 'epilepsy knowledge and increase in QOL']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",210.0,0.0794783,"Improvements in scores for sleep quality, anxiety, depression, self-efficacy, coping, and social support did not differ between groups.","[{'ForeName': 'Hsiu-Fang', 'Initials': 'HF', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, Tao-Yuan, Taiwan; Department of Nursing, Chang Gung Memorial Hospital at Linkou, Taiwan.'}, {'ForeName': 'Yun-Fang', 'Initials': 'YF', 'LastName': 'Tsai', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, Tao-Yuan, Taiwan; School of Nursing, Chang Gung University, Tao-Yuan, Taiwan; Department of Psychiatry, Chang Gung Memorial Hospital at Keelung, Keelung, Taiwan. Electronic address: yftsai@mail.cgu.edu.tw.'}, {'ForeName': 'Jun-Yu', 'Initials': 'JY', 'LastName': 'Fan', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, Tao-Yuan, Taiwan; Department of Nursing, Chang Gung Memorial Hospital at Linkou, Taiwan.'}, {'ForeName': 'Min-Chi', 'Initials': 'MC', 'LastName': 'Chen', 'Affiliation': 'Graduate Institute of Biomedical Sciences, Chang Gung University, Tao-Yuan, Taiwan.'}, {'ForeName': 'Mo-Song', 'Initials': 'MS', 'LastName': 'Hsi', 'Affiliation': 'Department of Neurology, Chang Gung Memorial Hospital at Linkou, Taiwan.'}, {'ForeName': 'Mau-Sun', 'Initials': 'MS', 'LastName': 'Hua', 'Affiliation': 'Department of Psychology, National Taiwan University, Taipei, Taiwan.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2021.107845'] 2281,33621809,Testing the effects of the GLP-1 receptor agonist exenatide on cocaine self-administration and subjective responses in humans with cocaine use disorder.,"BACKGROUND Preclinical rodent studies have demonstrated reduced cocaine taking after administration of glucagon-like peptide 1 (GLP-1) analogues. We investigated effects of a GLP-1 analogue (exenatide) on behavioral and subjective effects of cocaine in individuals with cocaine use disorder (CUD). METHODS Non-treatment-seeking CUD subjects underwent two human laboratory cocaine self-administration test sessions following an acute 3 -h pre-treatment with exenatide (5 mcg; subcutaneously) or placebo. Primary outcomes consisted of infusions of cocaine and visual analog scale self-ratings of euphoria and wanting cocaine. Secondary outcomes consisted of pertinent hormone levels (GLP-1, insulin, and amylin). RESULTS Thirteen individuals completed the study. Acute pretreatment with exenatide versus placebo did not change cocaine infusions (8.5 ± 1.2 vs. 9.1 ± 1.2; p = 0.39), self-reported euphoria (4.4 ± 0.8 vs. 4.1 ± 0.8; p = 0.21), or wanting of cocaine (5.6 ± 0.9 vs. 5.4 ± 0.9; p = 0.46). Exenatide vs. placebo reduced levels of GLP-1 (p = 0.03) and insulin (p = 0.02). Self-administered cocaine also reduced levels of GLP-1 (p < 0.0001), insulin (p < 0.0001), and amylin (p < 0.0001). CONCLUSIONS We did not find evidence that low dose exenatide alters cocaine self-administration or the subjective effects of cocaine in people with CUD. Limitations such as single acute rather than chronic pre-treatment, as well as evaluation of only one dose, preclude drawing firm conclusions about the efficacy of exenatide. Exenatide and cocaine independently reduced levels of GLP-1 and insulin, while cocaine also reduced levels of amylin.",2021,Exenatide vs. placebo reduced levels of GLP-1 (p = 0.03) and insulin (p = 0.02).,"['Non-treatment-seeking CUD subjects underwent two human laboratory cocaine self-administration test sessions following an acute 3 -h pre-treatment with', 'Thirteen individuals completed the study', 'individuals with cocaine use disorder (CUD', 'humans with cocaine use disorder', 'people with CUD']","['GLP-1 receptor agonist exenatide', 'Exenatide vs. placebo', 'placebo', 'GLP-1 analogue (exenatide', 'exenatide versus placebo', 'exenatide', 'Exenatide and cocaine', 'cocaine']","['behavioral and subjective effects', 'pertinent hormone levels (GLP-1, insulin, and amylin', 'visual analog scale self-ratings of euphoria and wanting cocaine', 'levels of GLP-1 and insulin', 'levels of GLP-1']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0036589', 'cui_str': 'Self-administration of medication'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0063684', 'cui_str': 'Amylin'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0235146', 'cui_str': 'Euphoria'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",13.0,0.0754243,Exenatide vs. placebo reduced levels of GLP-1 (p = 0.03) and insulin (p = 0.02).,"[{'ForeName': 'Gustavo A', 'Initials': 'GA', 'LastName': 'Angarita', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, 300 George Street, Suite 901, New Haven, CT, 06511, USA; Clinical Neuroscience Research Unit, Connecticut Mental Health Center, 34 Park Street, New Haven, CT, 06519, USA. Electronic address: gustavo.angarita@yale.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Matuskey', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, 300 George Street, Suite 901, New Haven, CT, 06511, USA; Department of Radiology and Biomedical Imaging, Yale University School of Medicine, 801 Howard Ave, New Haven, CT, 06519, USA; Department of Neurology, Yale University School of Medicine, 15 York Street, New Haven, CT, 06510, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Pittman', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, 300 George Street, Suite 901, New Haven, CT, 06511, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Costeines', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, 300 George Street, Suite 901, New Haven, CT, 06511, USA; Clinical Neuroscience Research Unit, Connecticut Mental Health Center, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Marc N', 'Initials': 'MN', 'LastName': 'Potenza', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, 300 George Street, Suite 901, New Haven, CT, 06511, USA; Child Study Center, Yale University School of Medicine, New Haven, CT, 06510, USA; Department of Neuroscience, Yale University, New Haven, CT, 06510, USA; Connecticut Mental Health Center, New Haven, CT, 06519, USA; Connecticut Council on Problem Gambling, Wethersfield, CT, 06109, USA.'}, {'ForeName': 'Ania M', 'Initials': 'AM', 'LastName': 'Jastreboff', 'Affiliation': 'Department of Internal Medicine (Endocrinology & Metabolism), Yale University School of Medicine, New Haven, CT, 06519, USA; Department of Pediatrics (Pediatric Endocrinology), Yale University School of Medicine, New Haven, CT, 06520, USA.'}, {'ForeName': 'Heath D', 'Initials': 'HD', 'LastName': 'Schmidt', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 125 South 31stStreet, Philadelphia, PA, 19104, USA; Department of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, 125 South 31stStreet, Rm 2214, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Malison', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, 300 George Street, Suite 901, New Haven, CT, 06511, USA; Clinical Neuroscience Research Unit, Connecticut Mental Health Center, 34 Park Street, New Haven, CT, 06519, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.108614'] 2282,33625578,"Reply to Andreas Boehle, Frank Kahmann, Thomas Oliver Henkel, Joerg Zimmermann and Stefan Machten's to the Letter to the editor Re: results of a randomized trial of treatment modalities in patients with low or early-intermediate risk prostate cancer (PREFERE trial).",,2021,,['patients with low or early-intermediate risk prostate cancer (PREFERE trial'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],[],,0.0179056,,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wiegel', 'Affiliation': 'Department of Radiotherapy and Radiation Oncology, University Hospital Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany. thomas.wiegel@uniklinik-ulm.de.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Albers', 'Affiliation': 'Department of Urology, University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Detlef', 'Initials': 'D', 'LastName': 'Bartkowiak', 'Affiliation': 'Department of Radiotherapy and Radiation Oncology, University Hospital Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany.'}, {'ForeName': 'Roswitha', 'Initials': 'R', 'LastName': 'Bussar-Maatz', 'Affiliation': 'PREFERE Project Management, German Cancer Society, Berlin, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Härter', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Kristiansen', 'Affiliation': 'Institute of Pathology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Martus', 'Affiliation': 'Department of Clinical Epidemiology and Applied Biostatistics, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Wellek', 'Affiliation': 'Department of Medical Biostatistics, Epidemiology and Informatics, University of Mainz, Mainz, Germany.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Schmidberger', 'Affiliation': 'Department of Radiotherapy and Radiation Oncology, University Hospital Mainz, Mainz, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Grozinger', 'Affiliation': 'Department of Urology, Klinikum Leverkusen, Leverkusen, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Renner', 'Affiliation': 'Center for Urology, Lübeck, Germany.'}, {'ForeName': 'Fried', 'Initials': 'F', 'LastName': 'Schneider', 'Affiliation': 'Department of Urology, Klinikum Lippe Detmold, Detmold, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Burmester', 'Affiliation': 'Department of Urology, Vinzenzkrankenhaus, Hannover, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stöckle', 'Affiliation': 'Department of Urology, University Hospital Homburg/Saar, Homburg, Germany.'}]",Journal of cancer research and clinical oncology,['10.1007/s00432-021-03549-y'] 2283,33625509,Effect of Cigarette Constituent Messages With Engagement Text on Intention to Quit Smoking Among Adults Who Smoke Cigarettes: A Randomized Clinical Trial.,"Importance The US Food and Drug Administration (FDA) is required to communicate the risks of tobacco constituents to the public. Few studies have addressed how FDA media campaigns can effectively communicate about cigarette smoke constituents. Objective To examine whether messages about cigarette smoke constituents are effective in reducing smoking intentions and behaviors among adults who smoke. Design, Setting, and Participants This randomized clinical trial enrolled participants who were aged between 18 and 65 years, were English speakers, were living in the United States, and who smoked at least 100 cigarettes during their lifetime and now smoked every day or some days. Participants received daily messages via email for 15 days. Participants were randomized to 1 of 2 message conditions or a control group and reported their previous-day smoking behaviors daily. Follow-up surveys were conducted on days 16 and 32. Data were collected from June 2017 to April 2018 and analyzed from April to September 2018. Interventions The 3 groups were (1) constituent plus engagement messages (eg, ""Cigarette smoke contains arsenic. This causes heart damage."") that included the FDA as the source and engagement text (eg, ""Within 3 months of quitting, your heart and lungs work better. Ready to be tobacco free? You can quit. For free nicotine replacement, call 1-800-QUIT-NOW""); (2) constituent-only messages that did not list the FDA as the source or include engagement text; and (3) a control condition with messages about littering cigarette butts. Main Outcomes and Measures The primary outcome was the change in quit intentions (range, 1-4, with higher scores indicating stronger intentions) from pretest to day 16. Secondary outcome measures included daily smoking behaviors and quit attempts. Results A total of 789 participants (mean [SD] age, 43.4 [12.9] years; 483 [61.2%] women; 578 [73.3%] White; 717 [90.9%] non-Hispanic) were included in the study. The mean (SD) quit intention score was 2.5 (0.9) at pretest. Mean (SE) change in quit intention score from pretest to day 16 was 0.19 (0.07) points higher in the constituent plus engagement condition than in the control condition (P = .005) and 0.23 (0.07) points higher in the constituent-only condition compared with the control condition (P = .001). Participant reports of cigarettes smoked, forgone, and butted out were similar across study conditions at baseline and did not differ significantly at days 16 and 32 across study conditions. Viewing more messages was associated with an estimated decrease of 0.15 (SE, 0.01) cigarettes smoked per day per message viewed overall across conditions. Conclusions and Relevance To our knowledge, this is the first longitudinal test of cigarette constituent campaign messages in a national sample of adults who currently smoke. Messages about cigarette smoke constituents, with or without engagement text and source information, increased participants' intentions to quit, lending support to FDA efforts to educate consumers about such constituents. Trial Registration ClinicalTrials.gov Identifier: NCT03339206.",2021,"Messages about cigarette smoke constituents, with or without engagement text and source information, increased participants' intentions to quit, lending support to FDA efforts to educate consumers about such constituents. ","['adults who currently smoke', '43.4 [12.9] years; 483 [61.2%] women; 578 [73.3%] White; 717 [90.9%] non-Hispanic', '789 participants (mean [SD] age', 'Adults', 'Data were collected from June 2017 to April 2018 and analyzed from April to September 2018', 'participants who were aged between 18 and 65 years, were English speakers, were living in the United States, and who smoked at least 100 cigarettes during their lifetime and now smoked every day or some days', 'adults who smoke', 'Who Smoke Cigarettes']","['US Food and Drug Administration (FDA', 'Cigarette Constituent Messages', 'constituent plus engagement messages (eg, ""Cigarette smoke contains arsenic']","['Mean (SE) change in quit intention score', 'change in quit intentions', 'Intention to Quit Smoking', 'daily smoking behaviors and quit attempts', 'smoking intentions and behaviors', 'mean (SD) quit intention score']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517833', 'cui_str': '61.2'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}]","[{'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0729650', 'cui_str': 'Constituents'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0003818', 'cui_str': 'Arsenic'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1519383', 'cui_str': 'Smoking Behaviors'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",789.0,0.0754188,"Messages about cigarette smoke constituents, with or without engagement text and source information, increased participants' intentions to quit, lending support to FDA efforts to educate consumers about such constituents. ","[{'ForeName': 'Adam O', 'Initials': 'AO', 'LastName': 'Goldstein', 'Affiliation': 'Department of Family Medicine, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Kristen L', 'Initials': 'KL', 'LastName': 'Jarman', 'Affiliation': 'Department of Family Medicine, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Sarah D', 'Initials': 'SD', 'LastName': 'Kowitt', 'Affiliation': 'Department of Family Medicine, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Tara L', 'Initials': 'TL', 'LastName': 'Queen', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Kyung Su', 'Initials': 'KS', 'LastName': 'Kim', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Bonnie E', 'Initials': 'BE', 'LastName': 'Shook-Sa', 'Affiliation': 'Gillings School of Global Public Health, Department of Biostatistics, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Paschal', 'Initials': 'P', 'LastName': 'Sheeran', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Seth M', 'Initials': 'SM', 'LastName': 'Noar', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Leah M', 'Initials': 'LM', 'LastName': 'Ranney', 'Affiliation': 'Department of Family Medicine, University of North Carolina at Chapel Hill.'}]",JAMA network open,['10.1001/jamanetworkopen.2021.0045'] 2284,33623076,"A phase 1b randomised, placebo-controlled trial of nabiximols cannabinoid oromucosal spray with temozolomide in patients with recurrent glioblastoma.","BACKGROUND Preclinical data suggest some cannabinoids may exert antitumour effects against glioblastoma (GBM). Safety and preliminary efficacy of nabiximols oromucosal cannabinoid spray plus dose-intense temozolomide (DIT) was evaluated in patients with first recurrence of GBM. METHODS Part 1 was open-label and Part 2 was randomised, double-blind, and placebo-controlled. Both required individualised dose escalation. Patients received nabiximols (Part 1, n = 6; Part 2, n = 12) or placebo (Part 2 only, n = 9); maximum of 12 sprays/day with DIT for up to 12 months. Safety, efficacy, and temozolomide (TMZ) pharmacokinetics (PK) were monitored. RESULTS The most common treatment-emergent adverse events (TEAEs; both parts) were vomiting, dizziness, fatigue, nausea and headache. Most patients experienced TEAEs that were grade 2 or 3 (CTCAE). In Part 2, 33% of both nabiximols- and placebo-treated patients were progression-free at 6 months. Survival at 1 year was 83% for nabiximols- and 44% for placebo-treated patients (p = 0.042), although two patients died within the first 40 days of enrolment in the placebo arm. There were no apparent effects of nabiximols on TMZ PK. CONCLUSIONS With personalised dosing, nabiximols had acceptable safety and tolerability with no drug-drug interaction identified. The observed survival differences support further exploration in an adequately powered randomised controlled trial. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov: Part 1- NCT01812603; Part 2- NCT01812616.",2021,"The most common treatment-emergent adverse events (TEAEs; both parts) were vomiting, dizziness, fatigue, nausea and headache.","['Part 1 was open-label', 'patients with recurrent glioblastoma', 'patients with first recurrence of GBM']","['nabiximols cannabinoid oromucosal spray with temozolomide', 'nabiximols oromucosal cannabinoid spray plus dose-intense temozolomide (DIT', 'placebo']","['Safety, efficacy, and temozolomide (TMZ) pharmacokinetics (PK', 'vomiting, dizziness, fatigue, nausea and headache', 'progression-free', 'acceptable safety and tolerability', 'Survival']","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]","[{'cui': 'C2347556', 'cui_str': 'nabiximols'}, {'cui': 'C0006864', 'cui_str': 'cannabinoids'}, {'cui': 'C1273657', 'cui_str': 'Oromucosal spray'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C1299004', 'cui_str': 'Oromucosal route'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.634713,"The most common treatment-emergent adverse events (TEAEs; both parts) were vomiting, dizziness, fatigue, nausea and headache.","[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Twelves', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sabel', 'Affiliation': 'Department of Neurosurgery, Heinrich-Heine-University, Dusseldorf, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Checketts', 'Affiliation': 'GW Research Ltd., Sovereign House, Vision Park, Chivers Way, Histon, Cambridge, UK.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Miller', 'Affiliation': 'GW Research Ltd., Sovereign House, Vision Park, Chivers Way, Histon, Cambridge, UK.'}, {'ForeName': 'Bola', 'Initials': 'B', 'LastName': 'Tayo', 'Affiliation': 'GW Research Ltd., Sovereign House, Vision Park, Chivers Way, Histon, Cambridge, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Jove', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Brazil', 'Affiliation': ""Guy's and St Thomas Hospitals Cancer Centre, Guys Hospital, Great Maze Pond, London, UK.""}, {'ForeName': 'Susan C', 'Initials': 'SC', 'LastName': 'Short', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK. s.c.short@leeds.ac.uk.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",British journal of cancer,['10.1038/s41416-021-01259-3'] 2285,33622114,"Alpelisib for the treatment of PIK3CA -mutated, hormone receptor-positive, HER2-negative metastatic breast cancer.","Introduction : Two-thirds of advanced breast cancers are hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative (HR+/HER2-). Gene mutations in PIK3CA , encoding the PI3K catalytic subunit alpha of phosphatidyl-inositol 3-kinase (PI3K), are a frequent event in this population and are implicated in hormone therapy resistance. Alpelisib is a PI3K-alpha inhibitor and is the first PI3K inhibitor approved, in association with fulvestrant, by the FDA and EMA, based on improved progression-free survival (PFS) versus fulvestrant alone in a randomized phase III trial in HR+/HER2-, PIK3CA -mutated tumors following progression on/after HT. Areas covered : The scientific rationale, preclinical development, pharmacokinetics, and clinical efficacy/safety of alpelisib-fulvestrant are summarized. The role of alpelisib in the clinical setting is discussed, referencing current therapeutic options and clinical challenges associated with alpelisib's safety profile. Expert opinion : Alpelisib is an option for patients with HR+/HER2-, PIK3CA -mutated tumors whose disease progressed during/after aromatase inhibitor treatment. The PFS benefit appears clinically significant over fulvestrant alone, with a 7.9 months, non-significant, improvement in overall survival. Its safety profile requires strict patient selection, mainly based on baseline glycemic status, and close monitoring.",2021,"The PFS benefit appears clinically significant over fulvestrant alone, with a 7.9 months, non-significant, improvement in overall survival.","['patients with HR+/HER2-, PIK3CA -mutated tumors whose disease progressed during/after aromatase inhibitor treatment']","['hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative (HR+/HER2', 'alpelisib-fulvestrant']",['overall survival'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1451005', 'cui_str': 'PIK3CA protein, human'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C4055478', 'cui_str': 'alpelisib'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.0172118,"The PFS benefit appears clinically significant over fulvestrant alone, with a 7.9 months, non-significant, improvement in overall survival.","[{'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Leenhardt', 'Affiliation': 'Laboratoire de Pharmacocinétique, Faculté de Pharmacie, Université de Montpellier, Montpellier, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Alexandre', 'Affiliation': ""Département d'Oncologie Médicale, Institut du Cancer de Montpellier, Université de Montpellier, Montpellier, France.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Jacot', 'Affiliation': 'Institut de Recherche en Cancérologie de Montpellier (IRCM), INSERM U1194, Université de Montpellier, Montpellier, France.'}]",Expert opinion on pharmacotherapy,['10.1080/14656566.2021.1873952'] 2286,33819776,"Efficacy, feasibility and acceptability of the OptiMEDs tool for multidisciplinary medication review in nursing homes.","AIM(S) Exploring efficacy, feasibility and acceptability of a complex multifaced intervention (OptiMEDs) supporting multidisciplinary medication reviews in Belgian nursing homes (NHs). METHODS A pilot study in 2 intervention, 1 control NH was held, involving dementia and non-dementia NH residents (>65 years). OptiMEDs provided automated assessment of possible inappropriate medications (PIMs) and patient-specific nurse observation lists of potential side-effects. Medication changes were evaluated one month after the medication review. Feasibility and acceptability was collected via surveys among the health-care professionals. Trial registration NCT04142645, 31/10/2019. RESULTS Participants (n = 148, n = 100 in the intervention NHs) had a mean age of 87.2 years, with 75.0% females and 49.3% non-dementia patients. Prevalence of PIM use was 84.7% and of potential medication side-effects 84.5%, (range 1-19 per resident). One month after the intervention, the medication use decreased in 35.8% and PIM use in 25.9% of surviving intervention NHresidents (n = 88). GPs changed more medications when side-effects were observed (42% when side-effects present versus 12% when no side-effects, p = 0.019). Median workload for nurses was 45 min, 20 for pharmacists, and 8 for GPs. User satisfaction for the OptiMEDs tool was high (n = 33, median score of 8, IQR 6 -8), with GPs (n = 19) showing the highest appreciation. Nurses (n = 9) reported a median score on the System Usability Scale of 70 (IQR 55 - 72), with lower scores for learnability aspects. CONCLUSION The OptiMEDs intervention was feasible and user-friendly, showing decreases in the medication and PIM use; without affecting patient safety. A cluster-randomized trial is needed to explore impact on patient-related outcomes.",2021,"The OptiMEDs intervention was feasible and user-friendly, showing decreases in the medication and PIM use; without affecting patient safety.","['100 in the intervention NHs) had a mean age of 87.2 years, with 75.0% females and 49.3% non-dementia patients', 'Belgian nursing homes (NHs', 'Participants (n\xa0=\xa0148, n\xa0', 'nursing homes', '2 intervention, 1 control NH was held, involving dementia and non-dementia NH residents (>65 years']",['complex multifaced intervention (OptiMEDs'],"['User satisfaction', 'median score on the System Usability Scale', 'Feasibility and acceptability', 'Median workload for nurses', 'Efficacy, feasibility and acceptability']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0337797', 'cui_str': 'Belgians'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0330726,"The OptiMEDs intervention was feasible and user-friendly, showing decreases in the medication and PIM use; without affecting patient safety.","[{'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Wauters', 'Affiliation': 'Department of Basic and Applied Medical Sciences, Clinical Pharmacology Research Unit, Ghent University, Ghent, Belgium. Electronic address: maarten.wauters@ugent.be.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Elseviers', 'Affiliation': 'Department of Basic and Applied Medical Sciences, Clinical Pharmacology Research Unit, Ghent University, Ghent, Belgium; University of Antwerp, Centre for Research and Innovation in Care (CRIC), Wilrijk, Belgium.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Vander Stichele', 'Affiliation': 'Department of Basic and Applied Medical Sciences, Clinical Pharmacology Research Unit, Ghent University, Ghent, Belgium; RAMIT vzw, Research in Advanced Medical Informatics and Telematics, Ghent, Belgium.'}, {'ForeName': 'Tinne', 'Initials': 'T', 'LastName': 'Dilles', 'Affiliation': 'University of Antwerp, Centre for Research and Innovation in Care (CRIC), Wilrijk, Belgium.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Thienpont', 'Affiliation': 'RAMIT vzw, Research in Advanced Medical Informatics and Telematics, Ghent, Belgium.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Christiaens', 'Affiliation': 'Department of Basic and Applied Medical Sciences, Clinical Pharmacology Research Unit, Ghent University, Ghent, Belgium.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2021.104391'] 2287,33819769,"Bactericidal effect of Er,Cr:YSGG laser irradiation on endodontic biofilm: An ex vivo study.","AIM This ex vivo study aimed to evaluate the of Er,Cr:YSGG laser effectiveness in the decontamination of an endodontic biofilm. MATERIALS AND METHODS Seventy-three single rooted human teeth, freshly were chosen. Each tooth was exposed to four associated species in an endodontic biofilm (Enterococcus faecalis, Streptococcus salivarius, Porphyromonas gingivalis, and Prevotella intermedia) and randomly allocated to one of the seven experimental groups. The group 1 (7 teeth) was used to finalize the reliable biofilm-forming technique. The groups 2 and 3 (15 teeth each group) were irradiated with two different Er;Cr:YSGG laser settings (0,75 W - 40 Hz and 4 W - 40 Hz, respectively). The groups 4 and 5 (15 teeth each group) were irrigated with two different solutions and laser irradiated with the same settings (1,5 W - 15 Hz). The group 6 (6 teeth) was the control group treated only with 4 ml 2,5% NaOCl irrigation during 60 s. RESULTS The observations of group 2 and 3 specimens showed the ripeness of the biofilm with the presence of Enterococcus faecalis and Streptococcus salivarius in chains but in group 3 thermal edge effects produced by the optic fiber in the canal walls were present. The group 4 specimens observation showed an average cleaning of the root canal walls while on the canal walls of group 5 samples the apical third presented several debris and smear layer and in the centre cracks and melting dentin of the radicular wall were observed. CONCLUSION In those experimental conditions, this study, demonstrated that Er,Cr:YSGG laser has a canals decontamination ability when associated to NaOCl irrigation.",2021,"The group 4 specimens observation showed an average cleaning of the root canal walls while on the canal walls of group 5 samples the apical third presented several debris and smear layer and in the centre cracks and melting dentin of the radicular wall were observed. ","['Seventy-three single rooted human teeth, freshly were chosen']","['irradiated with two different Er;Cr:YSGG laser settings (0,75', 'Er,Cr:YSGG laser', 'Er,Cr:YSGG laser irradiation', 'control group treated only with 4\xa0ml 2,5% NaOCl irrigation']","['endodontic biofilm', 'average cleaning of the root canal walls']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C1277077', 'cui_str': 'Irradiated blood product'}, {'cui': 'C0879167', 'cui_str': 'Yttrium-Scandium-Gallium Garnet Lasers'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}]","[{'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C0081786', 'cui_str': 'Biofilm'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0205380', 'cui_str': 'Walled'}]",73.0,0.017378,"The group 4 specimens observation showed an average cleaning of the root canal walls while on the canal walls of group 5 samples the apical third presented several debris and smear layer and in the centre cracks and melting dentin of the radicular wall were observed. ","[{'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Merigo', 'Affiliation': ""University Côte d'Azur, Micoralis Research Laboratory UPR7354, 24 Avenue des Diables bleus, 06357 Nice Cedex 4, France. Electronic address: elisabetta.merigo@univ-cotedazur.fr.""}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Bufflier', 'Affiliation': 'Diplôme Universitaire Oral laser Applications (DUOLA), Université de Nice ""Sophia Antipolis"", 24 Avenue des Diables bleus, 06357 Nice Cedex 4, France. Electronic address: dr-bufflier@espace-dentaire-leman.fr.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Rocca', 'Affiliation': ""University Côte d'Azur, Micoralis Research Laboratory UPR7354, 24 Avenue des Diables bleus, 06357 Nice Cedex 4, France; 2(nd) Hospital, International Department of Stomatology, Shijiazhuang, Hebei Province, China. Electronic address: jean-paul.rocca@univ-cotedazur.fr.""}, {'ForeName': 'Marlène', 'Initials': 'M', 'LastName': 'Chevalier', 'Affiliation': ""University Côte d'Azur, Micoralis Research Laboratory UPR7354, 24 Avenue des Diables bleus, 06357 Nice Cedex 4, France. Electronic address: marlene.chevalier@univ-cotedazur.fr.""}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Medioni', 'Affiliation': ""University Côte d'Azur, Micoralis Research Laboratory UPR7354, 24 Avenue des Diables bleus, 06357 Nice Cedex 4, France. Electronic address: etienne.medioni@univ-cotedazur.fr.""}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Meng', 'Affiliation': '2(nd) Hospital, International Department of Stomatology, Shijiazhuang, Hebei Province, China. Electronic address: zhaomeng3718@163.com.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Fornaini', 'Affiliation': ""University Côte d'Azur, Micoralis Research Laboratory UPR7354, 24 Avenue des Diables bleus, 06357 Nice Cedex 4, France; 2(nd) Hospital, International Department of Stomatology, Shijiazhuang, Hebei Province, China. Electronic address: carlo@fornainident.it.""}]","Journal of photochemistry and photobiology. B, Biology",['10.1016/j.jphotobiol.2021.112185'] 2288,33819750,Rationale and study design of the CHIPPI-1808 trial: a phase III randomized clinical trial evaluating hyperthermic intraperitoneal chemotherapy (HIPEC) for stage III ovarian cancer patients treated with primary or interval cytoreductive surgery ☆ .,"BACKGROUND Ovarian cancer remains the most lethal gynecologic malignancy with high recurrence rates. Because recurrence involves primarily the peritoneum, intraperitoneal chemotherapy is being evaluated as a new approach to treat microscopic peritoneal disease. One trial showed that cisplatin-paclitaxel intraperitoneal chemotherapy with intravenous paclitaxel improved survival but increased morbidity. Another trial reported a significant improvement in overall survival (OS) and disease-free survival (DFS) without increasing the morbidity (P = 0.76) or mortality rates (hazard ratio 0.67, P = 0.02) after adding hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreduction. The current trial aims to evaluate the impact of adding HIPEC to primary or interval cytoreductive surgery for epithelial ovarian cancer (EOC) on the efficacy, safety, treatment feasibility, and quality of life. PATIENTS AND METHODS This is an international, multicenter, open-label, randomized (1 : 1), two-arm, phase III clinical trial that will enroll 432 patients with newly diagnosed International Federation of Gynecology and Obstetrics (FIGO) stage III EOC. Patients are randomized to receive or not HIPEC with the standard of care. Inclusion criteria include patients with FIGO stage III EOC, Fallopian tube carcinoma or primary peritoneal cancer who undergo complete primary or interval cytoreduction. The primary objective is to assess DFS of the addition of HIPEC. Secondary objectives are the assessment of OS, safety, return to intended oncologic treatment, quality of life and the trade-off between efficacy and morbidity. CONCLUSIONS The results might help extend the indications of HIPEC to include patients undergoing primary cytoreduction, providing a standardized protocol for HIPEC in EOC management and reliable information on the quality of life after adding HIPEC.",2021,"Another trial reported a significant improvement in overall survival (OS) and disease-free survival (DFS) without increasing the morbidity (P = 0.76) or mortality rates (hazard ratio 0.67, P = 0.02) after adding hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreduction.","['epithelial ovarian cancer (EOC', '432 patients with newly diagnosed International Federation of Gynecology and Obstetrics (FIGO) stage III EOC', 'stage III ovarian cancer patients treated with primary or interval cytoreductive surgery ☆ ', 'Inclusion criteria include patients with FIGO stage III EOC, Fallopian tube carcinoma or primary peritoneal cancer who undergo complete primary or interval cytoreduction']","['hyperthermic intraperitoneal chemotherapy (HIPEC', 'HIPEC to primary or interval cytoreductive surgery', 'cisplatin-paclitaxel intraperitoneal chemotherapy']","['efficacy, safety, treatment feasibility, and quality of life', 'assessment of OS, safety, return to intended oncologic treatment, quality of life and the trade-off between efficacy and morbidity', 'survival but increased morbidity', 'mortality rates', 'morbidity', 'overall survival (OS) and disease-free survival (DFS']","[{'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0278687', 'cui_str': 'Ovarian cancer stage III'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0238122', 'cui_str': 'Carcinoma of fallopian tube'}, {'cui': 'C0153467', 'cui_str': 'Malignant tumor of peritoneum'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0205478', 'cui_str': 'Oncologic'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",432.0,0.579215,"Another trial reported a significant improvement in overall survival (OS) and disease-free survival (DFS) without increasing the morbidity (P = 0.76) or mortality rates (hazard ratio 0.67, P = 0.02) after adding hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreduction.","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'El Hajj', 'Affiliation': 'Gynecologic Oncology Department, Oscar Lambret Cancer Centre, Lille, France. Electronic address: h-elhajj@o-lambret.fr.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Vanseymortier', 'Affiliation': 'Clinical Research and Innovation Department, Oscar Lambret Cancer Centre, Lille, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Hudry', 'Affiliation': 'Gynecologic Oncology Department, Oscar Lambret Cancer Centre, Lille, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Bogart', 'Affiliation': 'Clinical Research and Innovation Department, Oscar Lambret Cancer Centre, Lille, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Abdeddaim', 'Affiliation': 'Medical Oncology Department, Oscar Lambret Cancer Center, Lille, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Leblanc', 'Affiliation': 'Gynecologic Oncology Department, Oscar Lambret Cancer Centre, Lille, France.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Le Deley', 'Affiliation': 'Paris-Saclay University, Paris-Sud University, UVSQ, CESP, INSERM, Villejuif, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Narducci', 'Affiliation': 'Gynecologic Oncology Department, Oscar Lambret Cancer Centre, Lille, France.'}]",ESMO open,['10.1016/j.esmoop.2021.100098'] 2289,33626248,Hypothermic Machine Perfusion in Liver Transplantation - A Randomized Trial.,"BACKGROUND Transplantation of livers obtained from donors after circulatory death is associated with an increased risk of nonanastomotic biliary strictures. Hypothermic oxygenated machine perfusion of livers may reduce the incidence of biliary complications, but data from prospective, controlled studies are limited. METHODS In this multicenter, controlled trial, we randomly assigned patients who were undergoing transplantation of a liver obtained from a donor after circulatory death to receive that liver either after hypothermic oxygenated machine perfusion (machine-perfusion group) or after conventional static cold storage alone (control group). The primary end point was the incidence of nonanastomotic biliary strictures within 6 months after transplantation. Secondary end points included other graft-related and general complications. RESULTS A total of 160 patients were enrolled, of whom 78 received a machine-perfused liver and 78 received a liver after static cold storage only (4 patients did not receive a liver in this trial). Nonanastomotic biliary strictures occurred in 6% of the patients in the machine-perfusion group and in 18% of those in the control group (risk ratio, 0.36; 95% confidence interval [CI], 0.14 to 0.94; P = 0.03). Postreperfusion syndrome occurred in 12% of the recipients of a machine-perfused liver and in 27% of those in the control group (risk ratio, 0.43; 95% CI, 0.20 to 0.91). Early allograft dysfunction occurred in 26% of the machine-perfused livers, as compared with 40% of control livers (risk ratio, 0.61; 95% CI, 0.39 to 0.96). The cumulative number of treatments for nonanastomotic biliary strictures was lower by a factor of almost 4 after machine perfusion, as compared with control. The incidence of adverse events was similar in the two groups. CONCLUSIONS Hypothermic oxygenated machine perfusion led to a lower risk of nonanastomotic biliary strictures following the transplantation of livers obtained from donors after circulatory death than conventional static cold storage. (Funded by Fonds NutsOhra; DHOPE-DCD ClinicalTrials.gov number, NCT02584283.).",2021,"The cumulative number of treatments for nonanastomotic biliary strictures was lower by a factor of almost 4 after machine perfusion, as compared with control.","['patients who were undergoing transplantation of a liver obtained from a donor after circulatory death to receive that liver either after', '160 patients were enrolled, of whom 78 received a']","['Hypothermic oxygenated machine perfusion', 'machine-perfused liver and 78 received a liver after static cold storage', 'Hypothermic Machine Perfusion', 'hypothermic oxygenated machine perfusion (machine-perfusion group) or after conventional static cold storage alone (control group']","['nonanastomotic biliary strictures', 'cumulative number of treatments for nonanastomotic biliary strictures', 'incidence of nonanastomotic biliary strictures', 'Postreperfusion syndrome', 'graft-related and general complications', 'adverse events', 'Nonanastomotic biliary strictures', 'Early allograft dysfunction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0010405', 'cui_str': 'Cryopreservation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0597984', 'cui_str': 'Biliary stricture'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]",160.0,0.299372,"The cumulative number of treatments for nonanastomotic biliary strictures was lower by a factor of almost 4 after machine perfusion, as compared with control.","[{'ForeName': 'Rianne', 'Initials': 'R', 'LastName': 'van Rijn', 'Affiliation': 'From the Department of Surgery, Section of Hepatobiliary Surgery and Liver Transplantation (R.R., Y.V., O.B.L., V.E.M., R.J.P.), the Departments of Gastroenterology and Hepatology (A.P.B.) and Radiology (R.J.H., J.J.G.S.), University of Groningen, University Medical Center Groningen, Groningen, the Departments of Surgery (I.J.S., W.G.P., J.J.) and Gastroenterology and Hepatology (S.D.M.), Erasmus University Medical Center, Rotterdam, and the Departments of Surgery (J.I.E., V.A.L.H.) and Gastroenterology and Hepatology (B.H.), Leiden University Medical Center, Leiden - all in the Netherlands; the Institute of Liver Studies, Kings College Hospital NHS Foundation Trust, London (M.C.C., N.H.); the Transplantation Research Group, the Department of Microbiology, Immunology, and Transplantation, Katholieke Universiteit Leuven, and the Department of Abdominal Transplantation Surgery and Coordination, University Hospitals Leuven, Leuven (N.G., I.J., D.M.), and the Department of Transplant Surgery, Ghent University Hospital, Ghent (R.I.T., A.V.) - both in Belgium.'}, {'ForeName': 'Ivo J', 'Initials': 'IJ', 'LastName': 'Schurink', 'Affiliation': 'From the Department of Surgery, Section of Hepatobiliary Surgery and Liver Transplantation (R.R., Y.V., O.B.L., V.E.M., R.J.P.), the Departments of Gastroenterology and Hepatology (A.P.B.) and Radiology (R.J.H., J.J.G.S.), University of Groningen, University Medical Center Groningen, Groningen, the Departments of Surgery (I.J.S., W.G.P., J.J.) and Gastroenterology and Hepatology (S.D.M.), Erasmus University Medical Center, Rotterdam, and the Departments of Surgery (J.I.E., V.A.L.H.) and Gastroenterology and Hepatology (B.H.), Leiden University Medical Center, Leiden - all in the Netherlands; the Institute of Liver Studies, Kings College Hospital NHS Foundation Trust, London (M.C.C., N.H.); the Transplantation Research Group, the Department of Microbiology, Immunology, and Transplantation, Katholieke Universiteit Leuven, and the Department of Abdominal Transplantation Surgery and Coordination, University Hospitals Leuven, Leuven (N.G., I.J., D.M.), and the Department of Transplant Surgery, Ghent University Hospital, Ghent (R.I.T., A.V.) - both in Belgium.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'de Vries', 'Affiliation': 'From the Department of Surgery, Section of Hepatobiliary Surgery and Liver Transplantation (R.R., Y.V., O.B.L., V.E.M., R.J.P.), the Departments of Gastroenterology and Hepatology (A.P.B.) and Radiology (R.J.H., J.J.G.S.), University of Groningen, University Medical Center Groningen, Groningen, the Departments of Surgery (I.J.S., W.G.P., J.J.) and Gastroenterology and Hepatology (S.D.M.), Erasmus University Medical Center, Rotterdam, and the Departments of Surgery (J.I.E., V.A.L.H.) and Gastroenterology and Hepatology (B.H.), Leiden University Medical Center, Leiden - all in the Netherlands; the Institute of Liver Studies, Kings College Hospital NHS Foundation Trust, London (M.C.C., N.H.); the Transplantation Research Group, the Department of Microbiology, Immunology, and Transplantation, Katholieke Universiteit Leuven, and the Department of Abdominal Transplantation Surgery and Coordination, University Hospitals Leuven, Leuven (N.G., I.J., D.M.), and the Department of Transplant Surgery, Ghent University Hospital, Ghent (R.I.T., A.V.) - both in Belgium.'}, {'ForeName': 'Aad P', 'Initials': 'AP', 'LastName': 'van den Berg', 'Affiliation': 'From the Department of Surgery, Section of Hepatobiliary Surgery and Liver Transplantation (R.R., Y.V., O.B.L., V.E.M., R.J.P.), the Departments of Gastroenterology and Hepatology (A.P.B.) and Radiology (R.J.H., J.J.G.S.), University of Groningen, University Medical Center Groningen, Groningen, the Departments of Surgery (I.J.S., W.G.P., J.J.) and Gastroenterology and Hepatology (S.D.M.), Erasmus University Medical Center, Rotterdam, and the Departments of Surgery (J.I.E., V.A.L.H.) and Gastroenterology and Hepatology (B.H.), Leiden University Medical Center, Leiden - all in the Netherlands; the Institute of Liver Studies, Kings College Hospital NHS Foundation Trust, London (M.C.C., N.H.); the Transplantation Research Group, the Department of Microbiology, Immunology, and Transplantation, Katholieke Universiteit Leuven, and the Department of Abdominal Transplantation Surgery and Coordination, University Hospitals Leuven, Leuven (N.G., I.J., D.M.), and the Department of Transplant Surgery, Ghent University Hospital, Ghent (R.I.T., A.V.) - both in Belgium.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Cortes Cerisuelo', 'Affiliation': 'From the Department of Surgery, Section of Hepatobiliary Surgery and Liver Transplantation (R.R., Y.V., O.B.L., V.E.M., R.J.P.), the Departments of Gastroenterology and Hepatology (A.P.B.) and Radiology (R.J.H., J.J.G.S.), University of Groningen, University Medical Center Groningen, Groningen, the Departments of Surgery (I.J.S., W.G.P., J.J.) and Gastroenterology and Hepatology (S.D.M.), Erasmus University Medical Center, Rotterdam, and the Departments of Surgery (J.I.E., V.A.L.H.) and Gastroenterology and Hepatology (B.H.), Leiden University Medical Center, Leiden - all in the Netherlands; the Institute of Liver Studies, Kings College Hospital NHS Foundation Trust, London (M.C.C., N.H.); the Transplantation Research Group, the Department of Microbiology, Immunology, and Transplantation, Katholieke Universiteit Leuven, and the Department of Abdominal Transplantation Surgery and Coordination, University Hospitals Leuven, Leuven (N.G., I.J., D.M.), and the Department of Transplant Surgery, Ghent University Hospital, Ghent (R.I.T., A.V.) - both in Belgium.'}, {'ForeName': 'Sarwa', 'Initials': 'S', 'LastName': 'Darwish Murad', 'Affiliation': 'From the Department of Surgery, Section of Hepatobiliary Surgery and Liver Transplantation (R.R., Y.V., O.B.L., V.E.M., R.J.P.), the Departments of Gastroenterology and Hepatology (A.P.B.) and Radiology (R.J.H., J.J.G.S.), University of Groningen, University Medical Center Groningen, Groningen, the Departments of Surgery (I.J.S., W.G.P., J.J.) and Gastroenterology and Hepatology (S.D.M.), Erasmus University Medical Center, Rotterdam, and the Departments of Surgery (J.I.E., V.A.L.H.) and Gastroenterology and Hepatology (B.H.), Leiden University Medical Center, Leiden - all in the Netherlands; the Institute of Liver Studies, Kings College Hospital NHS Foundation Trust, London (M.C.C., N.H.); the Transplantation Research Group, the Department of Microbiology, Immunology, and Transplantation, Katholieke Universiteit Leuven, and the Department of Abdominal Transplantation Surgery and Coordination, University Hospitals Leuven, Leuven (N.G., I.J., D.M.), and the Department of Transplant Surgery, Ghent University Hospital, Ghent (R.I.T., A.V.) - both in Belgium.'}, {'ForeName': 'Joris I', 'Initials': 'JI', 'LastName': 'Erdmann', 'Affiliation': 'From the Department of Surgery, Section of Hepatobiliary Surgery and Liver Transplantation (R.R., Y.V., O.B.L., V.E.M., R.J.P.), the Departments of Gastroenterology and Hepatology (A.P.B.) and Radiology (R.J.H., J.J.G.S.), University of Groningen, University Medical Center Groningen, Groningen, the Departments of Surgery (I.J.S., W.G.P., J.J.) and Gastroenterology and Hepatology (S.D.M.), Erasmus University Medical Center, Rotterdam, and the Departments of Surgery (J.I.E., V.A.L.H.) and Gastroenterology and Hepatology (B.H.), Leiden University Medical Center, Leiden - all in the Netherlands; the Institute of Liver Studies, Kings College Hospital NHS Foundation Trust, London (M.C.C., N.H.); the Transplantation Research Group, the Department of Microbiology, Immunology, and Transplantation, Katholieke Universiteit Leuven, and the Department of Abdominal Transplantation Surgery and Coordination, University Hospitals Leuven, Leuven (N.G., I.J., D.M.), and the Department of Transplant Surgery, Ghent University Hospital, Ghent (R.I.T., A.V.) - both in Belgium.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Gilbo', 'Affiliation': 'From the Department of Surgery, Section of Hepatobiliary Surgery and Liver Transplantation (R.R., Y.V., O.B.L., V.E.M., R.J.P.), the Departments of Gastroenterology and Hepatology (A.P.B.) and Radiology (R.J.H., J.J.G.S.), University of Groningen, University Medical Center Groningen, Groningen, the Departments of Surgery (I.J.S., W.G.P., J.J.) and Gastroenterology and Hepatology (S.D.M.), Erasmus University Medical Center, Rotterdam, and the Departments of Surgery (J.I.E., V.A.L.H.) and Gastroenterology and Hepatology (B.H.), Leiden University Medical Center, Leiden - all in the Netherlands; the Institute of Liver Studies, Kings College Hospital NHS Foundation Trust, London (M.C.C., N.H.); the Transplantation Research Group, the Department of Microbiology, Immunology, and Transplantation, Katholieke Universiteit Leuven, and the Department of Abdominal Transplantation Surgery and Coordination, University Hospitals Leuven, Leuven (N.G., I.J., D.M.), and the Department of Transplant Surgery, Ghent University Hospital, Ghent (R.I.T., A.V.) - both in Belgium.'}, {'ForeName': 'Robbert J', 'Initials': 'RJ', 'LastName': 'de Haas', 'Affiliation': 'From the Department of Surgery, Section of Hepatobiliary Surgery and Liver Transplantation (R.R., Y.V., O.B.L., V.E.M., R.J.P.), the Departments of Gastroenterology and Hepatology (A.P.B.) and Radiology (R.J.H., J.J.G.S.), University of Groningen, University Medical Center Groningen, Groningen, the Departments of Surgery (I.J.S., W.G.P., J.J.) and Gastroenterology and Hepatology (S.D.M.), Erasmus University Medical Center, Rotterdam, and the Departments of Surgery (J.I.E., V.A.L.H.) and Gastroenterology and Hepatology (B.H.), Leiden University Medical Center, Leiden - all in the Netherlands; the Institute of Liver Studies, Kings College Hospital NHS Foundation Trust, London (M.C.C., N.H.); the Transplantation Research Group, the Department of Microbiology, Immunology, and Transplantation, Katholieke Universiteit Leuven, and the Department of Abdominal Transplantation Surgery and Coordination, University Hospitals Leuven, Leuven (N.G., I.J., D.M.), and the Department of Transplant Surgery, Ghent University Hospital, Ghent (R.I.T., A.V.) - both in Belgium.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Heaton', 'Affiliation': 'From the Department of Surgery, Section of Hepatobiliary Surgery and Liver Transplantation (R.R., Y.V., O.B.L., V.E.M., R.J.P.), the Departments of Gastroenterology and Hepatology (A.P.B.) and Radiology (R.J.H., J.J.G.S.), University of Groningen, University Medical Center Groningen, Groningen, the Departments of Surgery (I.J.S., W.G.P., J.J.) and Gastroenterology and Hepatology (S.D.M.), Erasmus University Medical Center, Rotterdam, and the Departments of Surgery (J.I.E., V.A.L.H.) and Gastroenterology and Hepatology (B.H.), Leiden University Medical Center, Leiden - all in the Netherlands; the Institute of Liver Studies, Kings College Hospital NHS Foundation Trust, London (M.C.C., N.H.); the Transplantation Research Group, the Department of Microbiology, Immunology, and Transplantation, Katholieke Universiteit Leuven, and the Department of Abdominal Transplantation Surgery and Coordination, University Hospitals Leuven, Leuven (N.G., I.J., D.M.), and the Department of Transplant Surgery, Ghent University Hospital, Ghent (R.I.T., A.V.) - both in Belgium.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'van Hoek', 'Affiliation': 'From the Department of Surgery, Section of Hepatobiliary Surgery and Liver Transplantation (R.R., Y.V., O.B.L., V.E.M., R.J.P.), the Departments of Gastroenterology and Hepatology (A.P.B.) and Radiology (R.J.H., J.J.G.S.), University of Groningen, University Medical Center Groningen, Groningen, the Departments of Surgery (I.J.S., W.G.P., J.J.) and Gastroenterology and Hepatology (S.D.M.), Erasmus University Medical Center, Rotterdam, and the Departments of Surgery (J.I.E., V.A.L.H.) and Gastroenterology and Hepatology (B.H.), Leiden University Medical Center, Leiden - all in the Netherlands; the Institute of Liver Studies, Kings College Hospital NHS Foundation Trust, London (M.C.C., N.H.); the Transplantation Research Group, the Department of Microbiology, Immunology, and Transplantation, Katholieke Universiteit Leuven, and the Department of Abdominal Transplantation Surgery and Coordination, University Hospitals Leuven, Leuven (N.G., I.J., D.M.), and the Department of Transplant Surgery, Ghent University Hospital, Ghent (R.I.T., A.V.) - both in Belgium.'}, {'ForeName': 'Volkert A L', 'Initials': 'VAL', 'LastName': 'Huurman', 'Affiliation': 'From the Department of Surgery, Section of Hepatobiliary Surgery and Liver Transplantation (R.R., Y.V., O.B.L., V.E.M., R.J.P.), the Departments of Gastroenterology and Hepatology (A.P.B.) and Radiology (R.J.H., J.J.G.S.), University of Groningen, University Medical Center Groningen, Groningen, the Departments of Surgery (I.J.S., W.G.P., J.J.) and Gastroenterology and Hepatology (S.D.M.), Erasmus University Medical Center, Rotterdam, and the Departments of Surgery (J.I.E., V.A.L.H.) and Gastroenterology and Hepatology (B.H.), Leiden University Medical Center, Leiden - all in the Netherlands; the Institute of Liver Studies, Kings College Hospital NHS Foundation Trust, London (M.C.C., N.H.); the Transplantation Research Group, the Department of Microbiology, Immunology, and Transplantation, Katholieke Universiteit Leuven, and the Department of Abdominal Transplantation Surgery and Coordination, University Hospitals Leuven, Leuven (N.G., I.J., D.M.), and the Department of Transplant Surgery, Ghent University Hospital, Ghent (R.I.T., A.V.) - both in Belgium.'}, {'ForeName': 'Ina', 'Initials': 'I', 'LastName': 'Jochmans', 'Affiliation': 'From the Department of Surgery, Section of Hepatobiliary Surgery and Liver Transplantation (R.R., Y.V., O.B.L., V.E.M., R.J.P.), the Departments of Gastroenterology and Hepatology (A.P.B.) and Radiology (R.J.H., J.J.G.S.), University of Groningen, University Medical Center Groningen, Groningen, the Departments of Surgery (I.J.S., W.G.P., J.J.) and Gastroenterology and Hepatology (S.D.M.), Erasmus University Medical Center, Rotterdam, and the Departments of Surgery (J.I.E., V.A.L.H.) and Gastroenterology and Hepatology (B.H.), Leiden University Medical Center, Leiden - all in the Netherlands; the Institute of Liver Studies, Kings College Hospital NHS Foundation Trust, London (M.C.C., N.H.); the Transplantation Research Group, the Department of Microbiology, Immunology, and Transplantation, Katholieke Universiteit Leuven, and the Department of Abdominal Transplantation Surgery and Coordination, University Hospitals Leuven, Leuven (N.G., I.J., D.M.), and the Department of Transplant Surgery, Ghent University Hospital, Ghent (R.I.T., A.V.) - both in Belgium.'}, {'ForeName': 'Otto B', 'Initials': 'OB', 'LastName': 'van Leeuwen', 'Affiliation': 'From the Department of Surgery, Section of Hepatobiliary Surgery and Liver Transplantation (R.R., Y.V., O.B.L., V.E.M., R.J.P.), the Departments of Gastroenterology and Hepatology (A.P.B.) and Radiology (R.J.H., J.J.G.S.), University of Groningen, University Medical Center Groningen, Groningen, the Departments of Surgery (I.J.S., W.G.P., J.J.) and Gastroenterology and Hepatology (S.D.M.), Erasmus University Medical Center, Rotterdam, and the Departments of Surgery (J.I.E., V.A.L.H.) and Gastroenterology and Hepatology (B.H.), Leiden University Medical Center, Leiden - all in the Netherlands; the Institute of Liver Studies, Kings College Hospital NHS Foundation Trust, London (M.C.C., N.H.); the Transplantation Research Group, the Department of Microbiology, Immunology, and Transplantation, Katholieke Universiteit Leuven, and the Department of Abdominal Transplantation Surgery and Coordination, University Hospitals Leuven, Leuven (N.G., I.J., D.M.), and the Department of Transplant Surgery, Ghent University Hospital, Ghent (R.I.T., A.V.) - both in Belgium.'}, {'ForeName': 'Vincent E', 'Initials': 'VE', 'LastName': 'de Meijer', 'Affiliation': 'From the Department of Surgery, Section of Hepatobiliary Surgery and Liver Transplantation (R.R., Y.V., O.B.L., V.E.M., R.J.P.), the Departments of Gastroenterology and Hepatology (A.P.B.) and Radiology (R.J.H., J.J.G.S.), University of Groningen, University Medical Center Groningen, Groningen, the Departments of Surgery (I.J.S., W.G.P., J.J.) and Gastroenterology and Hepatology (S.D.M.), Erasmus University Medical Center, Rotterdam, and the Departments of Surgery (J.I.E., V.A.L.H.) and Gastroenterology and Hepatology (B.H.), Leiden University Medical Center, Leiden - all in the Netherlands; the Institute of Liver Studies, Kings College Hospital NHS Foundation Trust, London (M.C.C., N.H.); the Transplantation Research Group, the Department of Microbiology, Immunology, and Transplantation, Katholieke Universiteit Leuven, and the Department of Abdominal Transplantation Surgery and Coordination, University Hospitals Leuven, Leuven (N.G., I.J., D.M.), and the Department of Transplant Surgery, Ghent University Hospital, Ghent (R.I.T., A.V.) - both in Belgium.'}, {'ForeName': 'Diethard', 'Initials': 'D', 'LastName': 'Monbaliu', 'Affiliation': 'From the Department of Surgery, Section of Hepatobiliary Surgery and Liver Transplantation (R.R., Y.V., O.B.L., V.E.M., R.J.P.), the Departments of Gastroenterology and Hepatology (A.P.B.) and Radiology (R.J.H., J.J.G.S.), University of Groningen, University Medical Center Groningen, Groningen, the Departments of Surgery (I.J.S., W.G.P., J.J.) and Gastroenterology and Hepatology (S.D.M.), Erasmus University Medical Center, Rotterdam, and the Departments of Surgery (J.I.E., V.A.L.H.) and Gastroenterology and Hepatology (B.H.), Leiden University Medical Center, Leiden - all in the Netherlands; the Institute of Liver Studies, Kings College Hospital NHS Foundation Trust, London (M.C.C., N.H.); the Transplantation Research Group, the Department of Microbiology, Immunology, and Transplantation, Katholieke Universiteit Leuven, and the Department of Abdominal Transplantation Surgery and Coordination, University Hospitals Leuven, Leuven (N.G., I.J., D.M.), and the Department of Transplant Surgery, Ghent University Hospital, Ghent (R.I.T., A.V.) - both in Belgium.'}, {'ForeName': 'Wojciech G', 'Initials': 'WG', 'LastName': 'Polak', 'Affiliation': 'From the Department of Surgery, Section of Hepatobiliary Surgery and Liver Transplantation (R.R., Y.V., O.B.L., V.E.M., R.J.P.), the Departments of Gastroenterology and Hepatology (A.P.B.) and Radiology (R.J.H., J.J.G.S.), University of Groningen, University Medical Center Groningen, Groningen, the Departments of Surgery (I.J.S., W.G.P., J.J.) and Gastroenterology and Hepatology (S.D.M.), Erasmus University Medical Center, Rotterdam, and the Departments of Surgery (J.I.E., V.A.L.H.) and Gastroenterology and Hepatology (B.H.), Leiden University Medical Center, Leiden - all in the Netherlands; the Institute of Liver Studies, Kings College Hospital NHS Foundation Trust, London (M.C.C., N.H.); the Transplantation Research Group, the Department of Microbiology, Immunology, and Transplantation, Katholieke Universiteit Leuven, and the Department of Abdominal Transplantation Surgery and Coordination, University Hospitals Leuven, Leuven (N.G., I.J., D.M.), and the Department of Transplant Surgery, Ghent University Hospital, Ghent (R.I.T., A.V.) - both in Belgium.'}, {'ForeName': 'Jules J G', 'Initials': 'JJG', 'LastName': 'Slangen', 'Affiliation': 'From the Department of Surgery, Section of Hepatobiliary Surgery and Liver Transplantation (R.R., Y.V., O.B.L., V.E.M., R.J.P.), the Departments of Gastroenterology and Hepatology (A.P.B.) and Radiology (R.J.H., J.J.G.S.), University of Groningen, University Medical Center Groningen, Groningen, the Departments of Surgery (I.J.S., W.G.P., J.J.) and Gastroenterology and Hepatology (S.D.M.), Erasmus University Medical Center, Rotterdam, and the Departments of Surgery (J.I.E., V.A.L.H.) and Gastroenterology and Hepatology (B.H.), Leiden University Medical Center, Leiden - all in the Netherlands; the Institute of Liver Studies, Kings College Hospital NHS Foundation Trust, London (M.C.C., N.H.); the Transplantation Research Group, the Department of Microbiology, Immunology, and Transplantation, Katholieke Universiteit Leuven, and the Department of Abdominal Transplantation Surgery and Coordination, University Hospitals Leuven, Leuven (N.G., I.J., D.M.), and the Department of Transplant Surgery, Ghent University Hospital, Ghent (R.I.T., A.V.) - both in Belgium.'}, {'ForeName': 'Roberto I', 'Initials': 'RI', 'LastName': 'Troisi', 'Affiliation': 'From the Department of Surgery, Section of Hepatobiliary Surgery and Liver Transplantation (R.R., Y.V., O.B.L., V.E.M., R.J.P.), the Departments of Gastroenterology and Hepatology (A.P.B.) and Radiology (R.J.H., J.J.G.S.), University of Groningen, University Medical Center Groningen, Groningen, the Departments of Surgery (I.J.S., W.G.P., J.J.) and Gastroenterology and Hepatology (S.D.M.), Erasmus University Medical Center, Rotterdam, and the Departments of Surgery (J.I.E., V.A.L.H.) and Gastroenterology and Hepatology (B.H.), Leiden University Medical Center, Leiden - all in the Netherlands; the Institute of Liver Studies, Kings College Hospital NHS Foundation Trust, London (M.C.C., N.H.); the Transplantation Research Group, the Department of Microbiology, Immunology, and Transplantation, Katholieke Universiteit Leuven, and the Department of Abdominal Transplantation Surgery and Coordination, University Hospitals Leuven, Leuven (N.G., I.J., D.M.), and the Department of Transplant Surgery, Ghent University Hospital, Ghent (R.I.T., A.V.) - both in Belgium.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Vanlander', 'Affiliation': 'From the Department of Surgery, Section of Hepatobiliary Surgery and Liver Transplantation (R.R., Y.V., O.B.L., V.E.M., R.J.P.), the Departments of Gastroenterology and Hepatology (A.P.B.) and Radiology (R.J.H., J.J.G.S.), University of Groningen, University Medical Center Groningen, Groningen, the Departments of Surgery (I.J.S., W.G.P., J.J.) and Gastroenterology and Hepatology (S.D.M.), Erasmus University Medical Center, Rotterdam, and the Departments of Surgery (J.I.E., V.A.L.H.) and Gastroenterology and Hepatology (B.H.), Leiden University Medical Center, Leiden - all in the Netherlands; the Institute of Liver Studies, Kings College Hospital NHS Foundation Trust, London (M.C.C., N.H.); the Transplantation Research Group, the Department of Microbiology, Immunology, and Transplantation, Katholieke Universiteit Leuven, and the Department of Abdominal Transplantation Surgery and Coordination, University Hospitals Leuven, Leuven (N.G., I.J., D.M.), and the Department of Transplant Surgery, Ghent University Hospital, Ghent (R.I.T., A.V.) - both in Belgium.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'de Jonge', 'Affiliation': 'From the Department of Surgery, Section of Hepatobiliary Surgery and Liver Transplantation (R.R., Y.V., O.B.L., V.E.M., R.J.P.), the Departments of Gastroenterology and Hepatology (A.P.B.) and Radiology (R.J.H., J.J.G.S.), University of Groningen, University Medical Center Groningen, Groningen, the Departments of Surgery (I.J.S., W.G.P., J.J.) and Gastroenterology and Hepatology (S.D.M.), Erasmus University Medical Center, Rotterdam, and the Departments of Surgery (J.I.E., V.A.L.H.) and Gastroenterology and Hepatology (B.H.), Leiden University Medical Center, Leiden - all in the Netherlands; the Institute of Liver Studies, Kings College Hospital NHS Foundation Trust, London (M.C.C., N.H.); the Transplantation Research Group, the Department of Microbiology, Immunology, and Transplantation, Katholieke Universiteit Leuven, and the Department of Abdominal Transplantation Surgery and Coordination, University Hospitals Leuven, Leuven (N.G., I.J., D.M.), and the Department of Transplant Surgery, Ghent University Hospital, Ghent (R.I.T., A.V.) - both in Belgium.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Porte', 'Affiliation': 'From the Department of Surgery, Section of Hepatobiliary Surgery and Liver Transplantation (R.R., Y.V., O.B.L., V.E.M., R.J.P.), the Departments of Gastroenterology and Hepatology (A.P.B.) and Radiology (R.J.H., J.J.G.S.), University of Groningen, University Medical Center Groningen, Groningen, the Departments of Surgery (I.J.S., W.G.P., J.J.) and Gastroenterology and Hepatology (S.D.M.), Erasmus University Medical Center, Rotterdam, and the Departments of Surgery (J.I.E., V.A.L.H.) and Gastroenterology and Hepatology (B.H.), Leiden University Medical Center, Leiden - all in the Netherlands; the Institute of Liver Studies, Kings College Hospital NHS Foundation Trust, London (M.C.C., N.H.); the Transplantation Research Group, the Department of Microbiology, Immunology, and Transplantation, Katholieke Universiteit Leuven, and the Department of Abdominal Transplantation Surgery and Coordination, University Hospitals Leuven, Leuven (N.G., I.J., D.M.), and the Department of Transplant Surgery, Ghent University Hospital, Ghent (R.I.T., A.V.) - both in Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2031532'] 2290,33639543,Heart-focused breathing and perceptions of burden in Alzheimer's caregivers: An online randomized controlled pilot study.,"Informal caregivers of patients with Alzheimer's disease (AD) often experience high stress and reduced wellbeing and quality of life. HeartMath's Heart Lock-In® technique has been shown to reduce stress. In a randomized controlled pilot study among ten informal AD caregivers, we examined a two-week ten-minute daily, internet delivered heart-focused breathing protocol (n = 5) compared to waitlist control (n = 5). Participants completed pre- and post- self-assessments of perceived caregiver burden, stress, quality of life, anxiety, self-compassion and heart rate variability (HRV). Quality of life improved significantly in the control group compared to intervention, while self-compassion and HRV trended towards the expected direction. Caregiver burden and anxiety worsened in the intervention vs. waitlist control, suggesting the perception of added stress related to the required new daily task. While heart-focused breathing may hold promise for improving aspects of the caregiving experience, exploring online delivery methods and schedules that do not add extra burden is needed.",2021,"Quality of life improved significantly in the control group compared to intervention, while self-compassion and HRV trended towards the expected direction.","[""Alzheimer's caregivers"", 'ten informal AD caregivers', ""Informal caregivers of patients with Alzheimer's disease (AD""]",['internet delivered heart-focused breathing protocol (n\xa0=\xa05) compared to waitlist control'],"['Quality of life', 'Caregiver burden and anxiety', 'self-assessments of perceived caregiver burden, stress, quality of life, anxiety, self-compassion and heart rate variability (HRV']","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}]",10.0,0.087476,"Quality of life improved significantly in the control group compared to intervention, while self-compassion and HRV trended towards the expected direction.","[{'ForeName': 'Taylor A', 'Initials': 'TA', 'LastName': 'James', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, 500 North 3rd Street, Phoenix, AZ 85004, USA. Electronic address: Taylorjamesrn@gmail.com.'}, {'ForeName': 'Dara', 'Initials': 'D', 'LastName': 'James', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, 500 North 3rd Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Linda K', 'Initials': 'LK', 'LastName': 'Larkey', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, 500 North 3rd Street, Phoenix, AZ 85004, USA.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2021.02.006'] 2291,33648940,Randomized Phase II Trial of Polyphenon E versus Placebo in Patients at High Risk of Recurrent Colonic Neoplasia.,"Polyphenon E (Poly E) is a green tea polyphenol preparation whose most active component is epigallocatechin gallate (EGCG). We studied the cancer preventive efficacy and safety of Poly E in subjects with rectal aberrant crypt foci (ACF), which represent putative precursors of colorectal cancers. Eligible subjects had prior colorectal advanced adenomas or cancers, and had ≥5 rectal ACF at a preregistration chromoendoscopy. Subjects ( N = 39) were randomized to 6 months of oral Poly E (780 mg EGCG) daily or placebo. Baseline characteristics were similar by treatment arm (all P >0.41); 32 of 39 (82%) subjects completed 6 months of treatment. The primary endpoint was percent reduction in rectal ACF at chromoendoscopy comparing before and after treatment. Among 32 subjects (15 Poly E, 17 placebo), percent change in rectal ACF number (baseline vs. 6 months) did not differ significantly between study arms (3.7% difference of means; P = 0.28); total ACF burden was also similar (-2.3% difference of means; P = 0.83). Adenoma recurrence rates at 6 months were similar by arm ( P > 0.35). Total drug received did not differ significantly by study arm; 31 (79%) subjects received ≥70% of prescribed Poly E. Poly E was well tolerated and adverse events (AE) did not differ significantly by arm. One subject on placebo had two grade 3 AEs; one subject had grade 2 hepatic transaminase elevations attributed to treatment. In conclusion, Poly E for 6 months did not significantly reduce rectal ACF number relative to placebo. Poly E was well tolerated and without significant toxicity at the dose studied. PREVENTION RELEVANCE: We report a chemoprevention trial of polyphenon E in subjects at high risk of colorectal cancer. The results show that polyphenon E was well tolerated, but did not significantly reduce the number of rectal aberrant crypt foci, a surrogate endpoint biomarker of colorectal cancer.",2021,Baseline characteristics were similar by treatment arm (all P >0.41); 32 of 39 (82%) subjects completed 6-months of treatment.,"['Patients at High Risk of Recurrent Colonic Neoplasia', 'Subjects (N=39', 'Eligible subjects had prior colorectal advanced adenomas or cancers, and had > 5 rectal ACF at a pre-registration chromoendoscopy', 'subjects with rectal aberrant crypt foci (ACF']","['Poly E', 'placebo', 'Polyphenon E versus Placebo', 'Polyphenon E (Poly E', 'oral Poly E (780 mg EGCG) daily or placebo']","['grade 2 hepatic transaminase elevations', 'tolerated and adverse events (AEs', 'Adenoma recurrence rates', 'rectal ACF', 'tolerated and without significant toxicity', 'rectal ACF number', 'total ACF burden']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C1879526', 'cui_str': 'Aberrant Crypt Foci'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0917976', 'cui_str': 'polyphenon E'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0059438', 'cui_str': 'epigallocatechin gallate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C1879526', 'cui_str': 'Aberrant Crypt Foci'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",39.0,0.404901,Baseline characteristics were similar by treatment arm (all P >0.41); 32 of 39 (82%) subjects completed 6-months of treatment.,"[{'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Sinicrope', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota. sinicrope.frank@mayo.edu.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Viggiano', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Navtej S', 'Initials': 'NS', 'LastName': 'Buttar', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Louis M Wong Kee', 'Initials': 'LMWK', 'LastName': 'Song', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Schroeder', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Kraichely', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Mark V', 'Initials': 'MV', 'LastName': 'Larson', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Sedlack', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Kisiel', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Gostout', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Abdul M', 'Initials': 'AM', 'LastName': 'Kalaiger', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Árpád V', 'Initials': 'ÁV', 'LastName': 'Patai', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': ""Della'Zanna"", 'Affiliation': 'Gastrointestinal and Other Cancers Research Group, Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Asad', 'Initials': 'A', 'LastName': 'Umar', 'Affiliation': 'Gastrointestinal and Other Cancers Research Group, Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Limburg', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Meyers', 'Affiliation': 'Department of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Nathan R', 'Initials': 'NR', 'LastName': 'Foster', 'Affiliation': 'Department of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Chung S', 'Initials': 'CS', 'LastName': 'Yang', 'Affiliation': 'Department of Chemical Biology, Ernest Mario School of Pharmacy, Rutgers University, The State University of New Jersey, Piscataway, New Jersey.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Sontag', 'Affiliation': 'Section of Gastroenterology, Edward Hines, Jr. VA Hospital, Hines, Illinois.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-20-0598'] 2292,33627069,"Evaluation of FindMyApps: protocol for a randomized controlled trial of the effectiveness and cost-effectiveness of a tablet-based intervention to improve self-management and social participation of community-dwelling people with mild dementia, compared to usual tablet use.","BACKGROUND For the rising number of people living with dementia, cost-effective community-based interventions to support psychosocial care are needed. The FindMyApps intervention has been developed with and for people with dementia and their caregivers, to help them use tablets to facilitate self-management and engagement in meaningful social activities. A feasibility study and exploratory pilot trial evaluating FindMyApps have been carried out. This definitive trial further evaluates the effectiveness of the intervention and, for the first time, the cost-effectiveness. METHODS A randomized controlled non-blinded single-center two-arm superiority trial will be conducted. Community-dwelling people with Mild Cognitive Impairment (MCI), or dementia with a Mini Mental-State Examination (MMSE) of > 17 and < 26, or Global Deterioration Scale 3 or 4, with an informal caregiver and access to a wireless internet connection will be included. In total, 150 patient-caregiver dyads will be randomly allocated to receive either usual care (control arm - tablet computer; n = 75 dyads) or usual care and the FindMyApps intervention (experimental arm - tablet computer and FindMyApps; n = 75 dyads). The primary outcomes are: for people with dementia, self-management and social participation; for caregivers, sense of competence. In addition to a main effect analysis, a cost-effectiveness analysis will be performed. In line with MRC guidance for evaluation of complex interventions a process evaluation will also be undertaken. DISCUSSION Results of the trial are expected to be available in 2023 and will be submitted for publication in international peer-reviewed scientific journals, in addition to conference presentations and reporting via the EU Marie Sklodowska-Curie DISTINCT ITN network. By providing evidence for or against the effectiveness and cost-effectiveness of the FindMyApps intervention, the results of the trial will influence national implementation of FindMyApps. We hope that the results of the trial will further stimulate research and development at the intersection of technology and psycho-social care in dementia. We hope to further demonstrate that the randomized controlled trial is a valuable and feasible means of evaluating new digital technologies, to stimulate further high-quality research in this growing field. TRIAL REGISTRATION NUMBER Netherlands Trial Register: NL8157 ; registered 15th November 2019.",2021,"The primary outcomes are: for people with dementia, self-management and social participation; for caregivers, sense of competence.","['community-dwelling people with mild dementia', '150 patient-caregiver dyads', 'Community-dwelling people with Mild Cognitive Impairment (MCI), or dementia with a Mini Mental-State Examination (MMSE) of >\u200917 and\u2009<\u200926, or Global Deterioration Scale 3 or 4, with an informal caregiver and access to a wireless internet connection will be included']","['NL8157 ', 'usual care (control arm - tablet computer; n\xa0=\u200975 dyads) or usual care and the FindMyApps intervention (experimental arm - tablet computer and FindMyApps; n\u2009=\u200975 dyads', 'tablet-based intervention']","['effectiveness and cost-effectiveness', 'people with dementia, self-management and social participation; for caregivers, sense of competence']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3494623', 'cui_str': 'Mild dementia'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C4537573', 'cui_str': 'Global Deterioration Scale'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4045980', 'cui_str': 'Tablet Computers'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0814554', 'cui_str': 'Social Participation'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",2023.0,0.113979,"The primary outcomes are: for people with dementia, self-management and social participation; for caregivers, sense of competence.","[{'ForeName': 'David Peter', 'Initials': 'DP', 'LastName': 'Neal', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Centers, location VUmc, Amsterdam, Netherlands.'}, {'ForeName': 'Yvonne J F', 'Initials': 'YJF', 'LastName': 'Kerkhof', 'Affiliation': 'Saxion University of Applied Sciences, Deventer, Netherlands.'}, {'ForeName': 'Teake P', 'Initials': 'TP', 'LastName': 'Ettema', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Centers, location VUmc, Amsterdam, Netherlands.'}, {'ForeName': 'Majon', 'Initials': 'M', 'LastName': 'Muller', 'Affiliation': 'Department of Internal Medicine, Amsterdam University Medical Centers, Amsterdam, Netherlands.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Bosmans', 'Affiliation': 'Department of Health Sciences, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Finnema', 'Affiliation': 'University Medical Centre Groningen, Groningen, Netherlands.'}, {'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Graff', 'Affiliation': 'Radboud University Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Dijkstra', 'Affiliation': 'Saxion University of Applied Sciences, Deventer, Netherlands.'}, {'ForeName': 'Max L', 'Initials': 'ML', 'LastName': 'Stek', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Centers, location VUmc, Amsterdam, Netherlands.'}, {'ForeName': 'Rose-Marie', 'Initials': 'RM', 'LastName': 'Dröes', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Centers, location VUmc, Amsterdam, Netherlands. rm.droes@amsterdamumc.nl.'}]",BMC geriatrics,['10.1186/s12877-021-02038-8'] 2293,33626005,Live Donor Assessment Tool (LDAT): A Turkish validity and reliability study.,"BACKGROUND/AIMS Psychosocial and psychiatric evaluations are crucial components of the assessment of a live donor candidate. The Live Donor Assessment Tool (LDAT) was developed for this purpose. This study aims to evaluate the validity and reliability of the Turkish version of LDAT. MATERIALS AND METHODS 132 live kidney or liver donor were referred to assess their psychosocial/psychiatric appropriateness for donation and were randomized for clinical evaluation as usual or with LDAT. The internal consistency of LDAT was measured by Chronbach's alpha coefficient. Inter-rater reliability was measured by using Spearman's correlation coefficient. The potential validity of LDAT was assessed by comparing LDAT scores to clinical decisions. The Mann-Whitney U test was used to compare LDAT scores across two clinically classified groups (acceptable/declined). Logistic regression was performed using LDAT scores to predict the clinical decision. RESULTS The Turkish version of LDAT items demonstrate good internal consistency (α=0.773). Inter-rater reliability of LDAT demonstrated strong correlation (ICC=0.72). LDAT scores differentiated the accepted/declined groups, and strongly predicted the clinical decision. With a cut-off score of 60.5, LDAT was found to have high sensitivity and specificity. CONCLUSION The Turkish version of LDAT was found to be a valid and reliable tool. LDAT could be an appropriate tool to assess live donor candidates.",2020,The Turkish version of LDAT was found to be a valid and reliable tool.,['132 live kidney or liver donor were referred to assess their psychosocial/psychiatric appropriateness for donation and were randomized for clinical evaluation as usual or with LDAT'],"['Live Donor Assessment Tool (LDAT', 'LDAT']",['LDAT scores'],"[{'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0302512', 'cui_str': 'Donor for liver transplant'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",132.0,0.0306166,The Turkish version of LDAT was found to be a valid and reliable tool.,"[{'ForeName': 'Berker', 'Initials': 'B', 'LastName': 'Duman', 'Affiliation': 'Division of Consultation-Liaison Psychiatry, Department of Psychiatry, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Oğuzhan', 'Initials': 'O', 'LastName': 'Herdi', 'Affiliation': 'Department of Psychiatry, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Damla', 'Initials': 'D', 'LastName': 'Sayar-Akaslan', 'Affiliation': 'Department of Psychiatry, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Elvan', 'Initials': 'E', 'LastName': 'Onur Kırımker', 'Affiliation': 'Department of Surgery, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Burçin', 'Initials': 'B', 'LastName': 'Çolak', 'Affiliation': 'Department of Psychiatry, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Ece', 'Initials': 'E', 'LastName': 'Ağtaş-Ertan', 'Affiliation': 'Department of Psychiatry, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Gülsüm', 'Initials': 'G', 'LastName': 'Çakar', 'Affiliation': 'Department of Psychiatry, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Jamal', 'Initials': 'J', 'LastName': 'Hasanlı', 'Affiliation': 'Department of Psychiatry, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Akın Fırat', 'Initials': 'AF', 'LastName': 'Kocaay', 'Affiliation': 'Department of Surgery, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Acar', 'Initials': 'A', 'LastName': 'Tüzüner', 'Affiliation': 'Department of Surgery, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Meltem', 'Initials': 'M', 'LastName': 'Koloğlu', 'Affiliation': 'Department of Pediatric Surgery, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Kaan', 'Initials': 'K', 'LastName': 'Karayalçın', 'Affiliation': 'Department of Surgery, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Beyza', 'Initials': 'B', 'LastName': 'Doğanay-Erdoğan', 'Affiliation': 'Department of Biostatistics, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Balcı', 'Affiliation': 'Department of Surgery, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Kumbasar', 'Affiliation': 'Division of Consultation-Liaison Psychiatry, Department of Psychiatry, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Iacoviello', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, USA.'}]",The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology,['10.5152/tjg.2020.19980'] 2294,33629920,"Associations between Early Psychosocial Deprivation, Cognitive and Psychiatric Morbidity, and Risk-taking Behavior in Adolescence.","Objective : Early psychosocial deprivation increases the risk of later cognitive and psychiatric problems, but not all deprived children show these difficulties. Here, we examine the extent to which psychosocial deprivation increases the risk of later cognitive and psychiatric difficulties and the downstream consequences of this for risk-taking behavior in adolescence. Method : Children abandoned to institutions early in life were randomly assigned to care-as-usual or a foster care intervention during infancy. A separate group of never-institutionalized children was recruited as a comparison sample. The current follow-up study included 165 children (51% female), 113 with a history of institutionalization and 52 with no such history. At age 12, caregivers reported on children's psychiatric difficulties, and their IQ was assessed by standardized testing. At 16 years, risk-taking behavior was assessed from youth self-reports. Results : Latent profile analysis revealed three subgroups of children with varying levels of cognitive and psychiatric difficulties: Low-Morbidity ( n = 104, 62.7%), Medium-Morbidity ( n = 46, 27.9%), and High-Morbidity ( n = 15, 9.4%). Nearly half of the institutionalized children belonged to the High- or Medium-Morbidity subgroups; and institutionally-reared children were significantly more likely to belong to one of these profiles than never-institutionalized children. Compared to the Low-Morbidity subgroup, membership in the Medium-Morbidity profile was associated with higher levels of risk-taking behavior at age 16 years. Conclusions : Children who experience psychosocial deprivation are considerably more likely to present with elevated cognitive and psychiatric difficulties in early adolescence and, for some children, this elevation is linked to heightened risk-taking behavior in later adolescence.",2021,Children abandoned to institutions early in life were randomly assigned to care-as-usual or a foster care intervention during infancy.,"['165 children (51% female), 113 with a history of institutionalization and 52 with no such history', 'Children abandoned to institutions early in life', 'A separate group of never-institutionalized children']",['care-as-usual or a foster care intervention'],"['risk of later cognitive and psychiatric problems', 'Medium-Morbidity', 'High-Morbidity', 'Early Psychosocial Deprivation, Cognitive and Psychiatric Morbidity, and Risk-taking Behavior in Adolescence', 'risk-taking behavior']","[{'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0021629', 'cui_str': 'Institutionalization'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C1272694', 'cui_str': 'Abandoned'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0562359', 'cui_str': 'Institutionalized'}]","[{'cui': 'C0419195', 'cui_str': 'Foster care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0033962', 'cui_str': 'Psychosocial deprivation'}, {'cui': 'C0035651', 'cui_str': 'Risk-Taking'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]",165.0,0.0329595,Children abandoned to institutions early in life were randomly assigned to care-as-usual or a foster care intervention during infancy.,"[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wade', 'Affiliation': 'Department of Applied Psychology and Human Development, University of Toronto.'}, {'ForeName': 'Devon', 'Initials': 'D', 'LastName': 'Carroll', 'Affiliation': ""Division of Developmental Medicine, Boston Children's Hospital of Harvard Medical School.""}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Fox', 'Affiliation': 'Department of Human Development and Quantitative Methodology, University of Maryland.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Zeanah', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Tulane University School of Medicine.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Nelson', 'Affiliation': ""Division of Developmental Medicine, Boston Children's Hospital of Harvard Medical School.""}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2020.1864737'] 2295,33629489,Authors' reply re: Vaginal Er:YAG laser application in the menopausal ewe model: a randomised estrogen and sham-controlled trial.,,2021,,['menopausal ewe model'],['Vaginal Er:YAG laser application'],[],"[{'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0337831', 'cui_str': 'Ewe'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0457903', 'cui_str': 'Erbium:YAG laser device'}, {'cui': 'C0185125', 'cui_str': 'Application'}]",[],,0.18191,,"[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Mackova', 'Affiliation': 'Department of Development and Regeneration, Cluster Urogenital, Abdominal and Plastic Surgery, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Deprest', 'Affiliation': 'Department of Development and Regeneration, Cluster Urogenital, Abdominal and Plastic Surgery, KU Leuven, Leuven, Belgium.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16652'] 2296,33634711,The Dramatic Impact of Explicit Instruction on Learning to Read in a New Writing System.,"There is profound and long-standing debate over the role of explicit instruction in reading acquisition. In this research, we investigated the impact of teaching regularities in the writing system explicitly rather than relying on learners to discover these regularities through text experience alone. Over 10 days, 48 adults learned to read novel words printed in two artificial writing systems. One group learned spelling-to-sound and spelling-to-meaning regularities solely through experience with the novel words, whereas the other group received a brief session of explicit instruction on these regularities before training commenced. Results showed that virtually all participants who received instruction performed at ceiling on tests that probed generalization of underlying regularities. In contrast, despite up to 18 hr of training on the novel words, less than 25% of discovery learners performed on par with those who received instruction. These findings illustrate the dramatic impact of teaching method on outcomes during reading acquisition.",2021,Results showed that virtually all participants who received instruction performed at ceiling on tests that probed generalization of underlying regularities.,['48 adults'],"['learned to read novel words printed in two artificial writing systems', 'learned spelling-to-sound and spelling-to-meaning regularities solely through experience with the novel words, whereas the other group received a brief session of explicit instruction', 'Explicit Instruction']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]",[],48.0,0.0192179,Results showed that virtually all participants who received instruction performed at ceiling on tests that probed generalization of underlying regularities.,"[{'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Rastle', 'Affiliation': 'Department of Psychology, Royal Holloway, University of London.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Lally', 'Affiliation': 'Department of Psychology, Royal Holloway, University of London.'}, {'ForeName': 'Matthew H', 'Initials': 'MH', 'LastName': 'Davis', 'Affiliation': 'MRC Cognition and Brain Sciences Unit, University of Cambridge.'}, {'ForeName': 'J S H', 'Initials': 'JSH', 'LastName': 'Taylor', 'Affiliation': 'Division of Psychology and Language Sciences, University College London.'}]",Psychological science,['10.1177/0956797620968790'] 2297,33631769,"""Consensus on Placebo and Nocebo Effects Connects Science with Practice:"" Reply to ""Questioning the Consensus on Placebo and Nocebo Effects"".",,2021,,[],['Placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.215415,,"[{'ForeName': 'Andrea W M', 'Initials': 'AWM', 'LastName': 'Evers', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Institute of Psychology, Leiden University, Leiden, The Netherlands, a.evers@fsw.leidenuniv.nl.'}, {'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Colloca', 'Affiliation': 'Departments of Pain Translational Symptoms Science and Anesthesiology, School of Nursing and Medicine, University of Maryland Baltimore, Baltimore, Maryland, USA.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Blease', 'Affiliation': 'General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Gaab', 'Affiliation': 'Faculty of Psychology, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Karin B', 'Initials': 'KB', 'LastName': 'Jensen', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Lauren Y', 'Initials': 'LY', 'LastName': 'Atlas', 'Affiliation': 'National Center for Complementary and Integrative Health, National Institute of Mental Health, and National Institute on Drug Abuse, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Chris J', 'Initials': 'CJ', 'LastName': 'Beedie', 'Affiliation': 'School of Psychology, University of Kent, Canterbury, United Kingdom.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Benedetti', 'Affiliation': 'Physiology and Neuroscience, University of Turin Medical School, Turin, Italy.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Bingel', 'Affiliation': 'Department of Neurology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Büchel', 'Affiliation': 'Department of Systems Neuroscience, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Jet', 'Initials': 'J', 'LastName': 'Bussemaker', 'Affiliation': 'Public Health and Primary Care, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Colagiuri', 'Affiliation': 'School of Psychology, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Alia J', 'Initials': 'AJ', 'LastName': 'Crum', 'Affiliation': 'Department of Psychology, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Damien G', 'Initials': 'DG', 'LastName': 'Finniss', 'Affiliation': 'Royal North Shore Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Geers', 'Affiliation': 'Department of Psychology, University of Toledo, Toledo, Ohio, USA.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Howick', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Regine', 'Initials': 'R', 'LastName': 'Klinger', 'Affiliation': 'Center for Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Stefanie Helena', 'Initials': 'SH', 'LastName': 'Meeuwis', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Institute of Psychology, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Meissner', 'Affiliation': 'Division of Health Promotion, University of Applied Sciences, Coburg, Germany.'}, {'ForeName': 'Vitaly', 'Initials': 'V', 'LastName': 'Napadow', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Charlestown, Massachusetts, USA.'}, {'ForeName': 'Keith J', 'Initials': 'KJ', 'LastName': 'Petrie', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Rief', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps University of Marburg, Marburg, Germany.'}, {'ForeName': 'Ionica', 'Initials': 'I', 'LastName': 'Smeets', 'Affiliation': 'Science Communication and Society, Institute of Biology, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Tor D', 'Initials': 'TD', 'LastName': 'Wager', 'Affiliation': 'Department of Psychological and Brain Sciences, Dartmouth College, Hanover, New Hampshire, USA.'}, {'ForeName': 'Vishvarani', 'Initials': 'V', 'LastName': 'Wanigasekera', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Vase', 'Affiliation': 'Department of Psychology and Behavioural Sciences, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kelley', 'Affiliation': 'Program in Placebo Studies, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Irving', 'Initials': 'I', 'LastName': 'Kirsch', 'Affiliation': 'Program in Placebo Studies, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Psychotherapy and psychosomatics,['10.1159/000514435'] 2298,33630677,Effects of 12 weeks of aerobic versus combined aerobic plus resistance exercise training on short-term blood pressure variability in patients with hypertension.,"Short-term blood pressure (BP) variability (BPV), measured by 24-h ambulatory BP monitoring (ABPM), has been independently related to a higher risk of cardiovascular events and target organ in hypertensive patients. The aim of this study was to compare the effects of two different exercise modalities on BPV in hypertensive patients enrolled in a cardiac rehabilitation program. This study is a randomized trial, with two intervention arms: 1 ) aerobic training (AT) and 2 ) combined aerobic and resistance training (CT). We studied 55 male patients with hypertension. They were randomly assigned either to AT or CT group. The training program lasted 12 wk for each group. Short-term BP variability was evaluated by means of average real variability (ARV), at baseline and after 12 wk, by ABPM. Systolic and diastolic 24-h BP values decreased significantly ( P < 0.01) in both groups, without between-groups differences ( P = 0.11). The 24-h systolic BP variability decreased in both groups (AT: from 8.4 ± 1.2 to 7.6 ± 0.8; CT: from 8.8 ± 1.5 to 7.1 ± 1.1), with a greater decrease in CT ( P = 0.02). Night-time systolic BPV decreased in CT (from 9.4 ± 1.3 to 8.3 ± 1.2, P = 0.03) and remained unchanged in AT (from 9.5 ± 1.2 to 9.4 ± 1.4). Day-time BPV decreased in both groups without between-groups differences ( P = 0.07). CT was more effective than AT in reducing short-term BPV in hypertensive patients, and both exercise modalities reduced BP to a same extent. CT appears to be a more appropriate exercise modality if the objective is to reduce BPV in addition to BP levels. NEW & NOTEWORTHY Combined exercise training (CT) including aerobic plus resistance exercises could be more effective in comparison with aerobic exercise (AT) alone in reducing blood pressure variability (BPV) in hypertensive patients. We report that CT was indeed more effective than AT in reducing short-term BPV, and both exercise modalities reduced BP levels to the same extent. CT appears to be a more appropriate exercise modality if the objective is to reduce BPV in addition to BP levels.",2021,"CONCLUSIONS CT was more effective than AT in reducing short-term BP variability in hypertensive patients while both exercise modalities reduced BP to a same extent.","['patients with hypertension', '55 males patients with hypertension', 'hypertensive patients', 'hypertensive patients enrolled in a cardiac rehabilitation program']","['exercise modalities', 'aerobic training (AT) and combined aerobic and resistance training (CT', 'CT', 'aerobic versus combined aerobic plus resistance exercise training', '24h ambulatory BP monitoring (ABPM']","['Short term BP variability', '24-h ambulatory BP monitoring Results: Systolic and diastolic 24-h BP values', 'BP variability', 'average real variability (ARV', 'CT', '24-h systolic BP variability', 'Nighttime systolic BP variability', 'Day-time BP variability', 'blood pressure (BP) variability (BPV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0026426', 'cui_str': 'Blood pressure monitoring'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0439511', 'cui_str': 'times/day'}, {'cui': 'C0006072', 'cui_str': 'Bovine papillomavirus'}]",55.0,0.0187863,"CONCLUSIONS CT was more effective than AT in reducing short-term BP variability in hypertensive patients while both exercise modalities reduced BP to a same extent.","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Caminiti', 'Affiliation': 'Department of Cardiology, IRCCS San Raffaele, Rome, Italy.'}, {'ForeName': 'Ferdinando', 'Initials': 'F', 'LastName': 'Iellamo', 'Affiliation': 'Department of Cardiology, IRCCS San Raffaele, Rome, Italy.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Mancuso', 'Affiliation': 'Department of Cardiology, IRCCS San Raffaele, Rome, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Cerrito', 'Affiliation': 'Department of Cardiology, IRCCS San Raffaele, Rome, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Montano', 'Affiliation': 'Dipartimento di Scienze Cliniche e Medicina Traslazionale, Università Tor Vergata, Rome, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Manzi', 'Affiliation': 'Department of Cardiology, IRCCS San Raffaele, Rome, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Volterrani', 'Affiliation': 'Department of Cardiology, IRCCS San Raffaele, Rome, Italy.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00910.2020'] 2299,33630662,Combined Memory Training: An Approach for Episodic Memory Deficits in Traumatic Brain Injury.,"Purpose The study aimed to test a combination of semantic memory and traditional episodic memory therapies on episodic memory deficits in adults with traumatic brain injury. Method Twenty-five participants who had been diagnosed with traumatic brain injury and had episodic memory deficits were randomly assigned either to a combined memory treatment group ( n = 16) or to a wait-list control group ( n = 9). Before and after treatment, they completed standardized neuropsychological testing for episodic memory and related cognitive domains, including the California Verbal Learning Test-Second Edition, the Controlled Oral Word Association Test, the University of Southern California Repeatable Episodic Memory Test, the Wechsler Abbreviated Scale of Intelligence-Second Edition Matrices, the Test of Everyday Attention, the Memory Assessment Clinics Self-Rating Scale, the Expressive Vocabulary Test-Second Edition, and the Story Recall subtest from the Rivermead Behavioural Memory Test. In addition to a traditional episodic memory therapy, the treatment group received a novel semantic memory-focused therapy, which involved participants finding meaningful connections between diverse concepts represented by sets of two or three words. Results The treatment group demonstrated statistically significant improvement in memory for list learning tasks, and there was a significant difference from pretest to posttest between the treatment group and the wait-list control group. Clinical significance was demonstrated for the treatment group using minimally important difference calculations. Conclusion Combined memory therapy resulted in significant improvements in episodic memory, semantic memory, and attention, in comparison to no treatment. Supplemental Material https://doi.org/10.23641/asha.14049968.",2021,"Results The treatment group demonstrated statistically significant improvement in memory for list learning tasks, and there was a significant difference from pretest to posttest between the treatment group and the wait-list control group.","['Traumatic Brain Injury', 'adults with traumatic brain injury', 'Method Twenty-five participants who had been diagnosed with traumatic brain injury and had episodic memory deficits']","['Combined Memory Training', 'traditional episodic memory therapy', 'combined memory treatment group ( n = 16) or to a wait-list control group', 'novel semantic memory-focused therapy', 'semantic memory and traditional episodic memory therapies']","['standardized neuropsychological testing for episodic memory and related cognitive domains, including the California Verbal Learning Test-Second Edition, the Controlled Oral Word Association Test, the University of Southern California Repeatable Episodic Memory Test, the Wechsler Abbreviated Scale of Intelligence-Second Edition Matrices, the Test of Everyday Attention, the Memory Assessment Clinics Self-Rating Scale, the Expressive Vocabulary Test-Second Edition, and the Story Recall subtest', 'episodic memory deficits', 'episodic memory, semantic memory, and attention', 'memory for list learning tasks']","[{'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0729377', 'cui_str': 'Memory skills training'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0542312', 'cui_str': 'Semantic memory'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}]","[{'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0589055', 'cui_str': 'California verbal learning test'}, {'cui': 'C0441795', 'cui_str': 'Second edition'}, {'cui': 'C3827022', 'cui_str': 'Controlled Oral Word Association Test'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0585653', 'cui_str': 'Test of everyday attention'}, {'cui': 'C0439045', 'cui_str': 'Memory assessment finding'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0042927', 'cui_str': 'Vocabulary Tests'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0542312', 'cui_str': 'Semantic memory'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",25.0,0.0325709,"Results The treatment group demonstrated statistically significant improvement in memory for list learning tasks, and there was a significant difference from pretest to posttest between the treatment group and the wait-list control group.","[{'ForeName': 'Elisabeth Cochran', 'Initials': 'EC', 'LastName': ""D'Angelo"", 'Affiliation': 'Department of Communication Sciences & Disorders, California State University, Sacramento.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Ober', 'Affiliation': 'Department of Human Ecology, University of California, Davis.'}, {'ForeName': 'Gregory K', 'Initials': 'GK', 'LastName': 'Shenaut', 'Affiliation': 'Department of Human Ecology, University of California, Davis.'}]",American journal of speech-language pathology,['10.1044/2020_AJSLP-20-00075'] 2300,33635156,eHealth parent education for hearing aid management: a pilot randomized controlled trial.,"OBJECTIVE Parents frequently experience challenges implementing daily routines important for consistent hearing aid management. Education that supports parents in learning new information and gaining confidence is essential for intervention success. We conducted a pilot study to test an eHealth program to determine if we could implement the program with adherence and affect important behavioural outcomes compared to treatment as usual. DESIGN Randomised controlled trial. STUDY SAMPLE Parents of children birth to 42 months who use hearing aids. Eighty-two parents were randomly assigned to the intervention or treatment-as-usual group. Four parents assigned to the intervention group did not continue after baseline testing. RESULTS The intervention was delivered successfully with low drop out (10%), high session completion (97%), and high program adherence. The intervention conditions showed significantly greater gains over time for knowledge, confidence, perceptions, and monitoring related to hearing aid management. Significant differences between groups were not observed for hearing aid use time. CONCLUSION We found that we could successfully implement this eHealth program and that it benefitted the participants in terms of knowledge and confidence with skills important for hearing aid management. Future research is needed to determine how to roll programs like this out on a larger scale.",2021,"The intervention conditions showed significantly greater gains over time for knowledge, confidence, perceptions, and monitoring related to hearing aid management.","['SAMPLE\n\n\nParents of children birth to 42\u2009months who use hearing aids', 'Eighty-two parents']",[],"['gains over time for knowledge, confidence, perceptions, and monitoring related to hearing aid management', 'hearing aid use time']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0581135', 'cui_str': 'Birth of child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C3816958', 'cui_str': '80'}]",[],"[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0567452', 'cui_str': 'Attention to hearing aid'}, {'cui': 'C0018768', 'cui_str': 'Hearing aid'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",82.0,0.0797324,"The intervention conditions showed significantly greater gains over time for knowledge, confidence, perceptions, and monitoring related to hearing aid management.","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Muñoz', 'Affiliation': 'Communication Disorders & Deaf Education, Utah State University, Logan, UT, USA.'}, {'ForeName': 'Guadalupe G', 'Initials': 'GG', 'LastName': 'San Miguel', 'Affiliation': 'Psychology, Utah State University, Logan, UT, USA.'}, {'ForeName': 'Tyson S', 'Initials': 'TS', 'LastName': 'Barrett', 'Affiliation': 'Office of Research Services, Utah State University, Logan, UT, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Kasin', 'Affiliation': 'Communication Disorders & Deaf Education, Utah State University, Logan, UT, USA.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Baughman', 'Affiliation': 'Communication Disorders & Deaf Education, Utah State University, Logan, UT, USA.'}, {'ForeName': 'Bailey', 'Initials': 'B', 'LastName': 'Reynolds', 'Affiliation': 'Communication Disorders & Deaf Education, Utah State University, Logan, UT, USA.'}, {'ForeName': 'Caitlyn', 'Initials': 'C', 'LastName': 'Ritter', 'Affiliation': 'Communication Disorders & Deaf Education, Utah State University, Logan, UT, USA.'}, {'ForeName': 'Makynzie', 'Initials': 'M', 'LastName': 'Larsen', 'Affiliation': 'Communication Disorders & Deaf Education, Utah State University, Logan, UT, USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Whicker', 'Affiliation': ""Rehabilitation, Primary Children's Hospital, Salt Lake City, UT, USA.""}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Twohig', 'Affiliation': 'Psychology, Utah State University, Logan, UT, USA.'}]",International journal of audiology,['10.1080/14992027.2021.1886354'] 2301,33634996,Evaluation of the safety and efficacy of using human menstrual blood-derived mesenchymal stromal cells in treating severe and critically ill COVID-19 patients: An exploratory clinical trial.,"The coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified in December 2019 and has subsequently spread worldwide. Currently, there is no effective method to cure COVID-19. Mesenchymal stromal cells (MSCs) may be able to effectively treat COVID-19, especially for severe and critical patients. Menstrual blood-derived MSCs have recently received much attention due to their superior proliferation ability and their lack of ethical problems. Forty-four patients were enrolled from January to April 2020 in a multicenter, open-label, nonrandomized, parallel-controlled exploratory trial. Twenty-six patients received allogeneic, menstrual blood-derived MSC therapy, and concomitant medications (experimental group), and 18 patients received only concomitant medications (control group). The experimental group was treated with three infusions totaling 9 × 10 7 MSCs, one infusion every other day. Primary and secondary endpoints related to safety and efficacy were assessed at various time points during the 1-month period following MSC infusion. Safety was measured using the frequency of treatment-related adverse events (AEs). Patients in the MSC group showed significantly lower mortality (7.69% died in the experimental group vs 33.33% in the control group; P = .048). There was a significant improvement in dyspnea while undergoing MSC infusion on days 1, 3, and 5. Additionally, SpO 2 was significantly improved following MSC infusion, and chest imaging results were improved in the experimental group in the first month after MSC infusion. The incidence of most AEs did not differ between the groups. MSC-based therapy may serve as a promising alternative method for treating severe and critical COVID-19.",2021,Patients in the MSC group showed significantly lower mortality (7.69% died in the experimental group vs 33.33% in the control group; P = .048).,"['treating severe and critically ill COVID-19 patients', 'Forty-four patients were enrolled from January to April 2020']","['allogeneic, menstrual blood-derived MSC therapy, and concomitant medications (experimental group), and 18 patients received only concomitant medications (control group', 'MSC', 'Mesenchymal stromal cells (MSCs', 'human menstrual blood-derived mesenchymal stromal cells', 'MSC-based therapy']","['dyspnea', 'safety and efficacy', 'Safety', 'frequency of treatment-related adverse events (AEs', 'MSC infusion, and chest imaging results', 'lower mortality']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0694689', 'cui_str': 'Menstrual blood'}, {'cui': 'C0074299', 'cui_str': 'selenomethylselenocysteine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3178844', 'cui_str': 'Mesenchymal Stromal Cells'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0074299', 'cui_str': 'selenomethylselenocysteine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C1531652', 'cui_str': 'Chest imaging'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",26.0,0.0563044,Patients in the MSC group showed significantly lower mortality (7.69% died in the experimental group vs 33.33% in the control group; P = .048).,"[{'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, P. R. China.'}, {'ForeName': 'Wanli', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': 'Department of Infectious Diseases, Renmin Hospital of Wuhan University, Wuhan, Hebei, P.R. China.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, P. R. China.'}, {'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Innovative Precision Medicine (IPM) Group, Hangzhou, Zhejiang, P. R. China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Innovative Precision Medicine (IPM) Group, Hangzhou, Zhejiang, P. R. China.'}, {'ForeName': 'Mengfei', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': 'Shulan (Hangzhou) Hospital, Zhejiang Shuren University Shulan International Medical College, Hangzhou, Zhejiang, P. R. China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Ye', 'Affiliation': 'Department of Infectious Diseases, Renmin Hospital of Wuhan University, Wuhan, Hebei, P.R. China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Innovative Precision Medicine (IPM) Group, Hangzhou, Zhejiang, P. R. China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, P. R. China.'}, {'ForeName': 'Xiaoyang', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Infectious Diseases, Renmin Hospital of Wuhan University, Wuhan, Hebei, P.R. China.'}, {'ForeName': 'Chenliang', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Department of Infectious Diseases, Renmin Hospital of Wuhan University, Wuhan, Hebei, P.R. China.'}, {'ForeName': 'Xiaobei', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Infectious Diseases, Renmin Hospital of Wuhan University, Wuhan, Hebei, P.R. China.'}, {'ForeName': 'Xiaoqin', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, P. R. China.'}, {'ForeName': 'Kaijin', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': 'State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, P. R. China.'}, {'ForeName': 'Hongliu', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': 'State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, P. R. China.'}, {'ForeName': 'Shufa', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, P. R. China.'}, {'ForeName': 'Wubian', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': 'Department of Infectious Diseases, Renmin Hospital of Wuhan University, Wuhan, Hebei, P.R. China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Infectious Diseases, Renmin Hospital of Wuhan University, Wuhan, Hebei, P.R. China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Infectious Diseases, Renmin Hospital of Wuhan University, Wuhan, Hebei, P.R. China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Innovative Precision Medicine (IPM) Group, Hangzhou, Zhejiang, P. R. China.'}, {'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Luo', 'Affiliation': 'Innovative Precision Medicine (IPM) Group, Hangzhou, Zhejiang, P. R. China.'}, {'ForeName': 'Yingyan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Innovative Precision Medicine (IPM) Group, Hangzhou, Zhejiang, P. R. China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Qu', 'Affiliation': 'Department of Respiratory Disease, Thoracic Disease Centre, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, P. R. China.'}, {'ForeName': 'Yifei', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, P. R. China.'}, {'ForeName': 'Wendi', 'Initials': 'W', 'LastName': 'Zheng', 'Affiliation': 'State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, P. R. China.'}, {'ForeName': 'Yingan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Infectious Diseases, Renmin Hospital of Wuhan University, Wuhan, Hebei, P.R. China.'}, {'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': 'Shulan (Hangzhou) Hospital, Zhejiang Shuren University Shulan International Medical College, Hangzhou, Zhejiang, P. R. China.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Xiang', 'Affiliation': 'State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, P. R. China.'}, {'ForeName': 'Lanjuan', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, P. R. China.'}]",Clinical and translational medicine,['10.1002/ctm2.297'] 2302,33636356,A comparison of the efficacy of normal saline and Savlon solutions in periurethral cleaning to reduce catheter-associated bacteriuria: A randomized control trial.,"OBJECTIVE Catheter-associated urinary tract infection (CAUTI) is a common nosocomial infection. However, there has been no randomized control trial (RCT) comparing the efficacy of periurethral cleaning solutions for reducing CAUTI. This study aimed to compare the efficacy of normal saline solution (NSS) and Savlon solution. METHODS A non-inferiority cross-over RCT was conducted to compare the 2 solutions by the incidence of significant bacteriuria (SB) on day 5 after Foley catheterization. Patients admitted to a tertiary referral hospital from June 2018 to August 2019 participated in the study. The acceptable prespecified non-inferiority margin was 10%. RESULTS There were 265 and 275 patients in the NSS and Savlon groups, respectively. The incidence of CAUTI was 2.65/1000 catheter-days, and the median duration of catheterization was 5 days (IQR 4, 7). There was no significant difference between the incidence of SB in the NSS and Savlon groups, as indicated by the adjusted difference of 0.6 (95% CI: -3.1-4.2). CONCLUSION This study was the first RCT in patients from multiple hospital units to compare the efficacy of the 2 solutions in the periurethral cleaning process. The study demonstrated non-inferiority of NSS to Savlon solution. THAI CLINICAL TRIALS REGISTRY STUDY ID TCTR20180518001.",2021,"The incidences of SB in NSS and Savlon groups had no significant difference, as indicated by the adjusted difference of 0.6 (95% CI of the difference: -3.1 to 4.2). ","['Catheter-Associated Bacteriuria', 'patients from various units', 'Patients admitted in a tertiary referral hospital from June 2018 to August 2019, were participated']","['Periurethral Cleaning between Normal Saline and Savlon Solutions', 'normal saline solution (NSS) and Savlon solution']","['median duration of catheterization', 'incidences of SB', 'incidence of significant bacteriuria (SB']","[{'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0004659', 'cui_str': 'Bacteriuria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0074089', 'cui_str': 'savlon'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0004659', 'cui_str': 'Bacteriuria'}]",,0.174825,"The incidences of SB in NSS and Savlon groups had no significant difference, as indicated by the adjusted difference of 0.6 (95% CI of the difference: -3.1 to 4.2). ","[{'ForeName': 'Sarin', 'Initials': 'S', 'LastName': 'Khahakaew', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand. Electronic address: s.khahakaew@gmail.com.'}, {'ForeName': 'Gompol', 'Initials': 'G', 'LastName': 'Suwanpimolkul', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand.'}, {'ForeName': 'Thanittha', 'Initials': 'T', 'LastName': 'Wongkeskij', 'Affiliation': 'Department of Microbiology, King Chulalongkorn Memorial Hospital, Bangkok 10330, Thailand.'}, {'ForeName': 'Napawan', 'Initials': 'N', 'LastName': 'Punakabutra', 'Affiliation': 'Department of Microbiology, King Chulalongkorn Memorial Hospital, Bangkok 10330, Thailand.'}, {'ForeName': 'Chusana', 'Initials': 'C', 'LastName': 'Suankratay', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2021.02.086'] 2303,33636297,Yoga versus home exercise program in children with enthesitis related arthritis: A pilot study.,"PURPOSE The aim was to compare the effects of yoga and home exercise program on lower extremity functional status, pain, and quality of life in children with enthesitis related arthritis (ERA). METHODS Twenty-one children with ERA were divided into two groups as yoga (n = 11) and home exercise (n = 10). Yoga group performed supervised yoga exercises twice a week for eight weeks. Home exercise group performed video-based exercises for the same period. Pain in rest and activity, lower extremity functional status, and quality of life were evaluated at baseline and following eight weeks. RESULTS The groups were similar at baseline (p > 0.05). All the parameters, except parent reported quality of life, significantly improved in yoga group (p < 0.05), where only stair climb test times significantly improved in home exercise group (p < 0.05). CONCLUSIONS Yoga seems promising for improving lower extremity functional status, pain, and quality of life as an exercise intervention in rehabilitation programs of children with ERA.",2021,"All the parameters, except parent reported quality of life, significantly improved in yoga group (p < 0.05), where only stair climb test times significantly improved in home exercise group (p < 0.05). ","['children with ERA', 'Twenty-one children with ERA', 'children with enthesitis related arthritis (ERA', 'Children with Enthesitis Related Arthritis']","['yoga and home exercise program', 'home exercise', 'Yoga versus Home Exercise Program', 'Home exercise group performed video-based exercises', 'supervised yoga exercises']","['quality of life', 'lower extremity functional status, pain, and quality of life', 'stair climb test times', 'Pain in rest and activity, lower extremity functional status, and quality of life']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C3715213', 'cui_str': '21'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C0429928', 'cui_str': 'Test time'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",21.0,0.02317,"All the parameters, except parent reported quality of life, significantly improved in yoga group (p < 0.05), where only stair climb test times significantly improved in home exercise group (p < 0.05). ","[{'ForeName': 'Ezgi', 'Initials': 'E', 'LastName': 'Yasar', 'Affiliation': 'Pamukkale University, Institute of Health Sciences, Department of Physical Therapy and Rehabilitation, Denizli, Turkey. Electronic address: ezgiyasar4@gmail.com.'}, {'ForeName': 'Erdogan', 'Initials': 'E', 'LastName': 'Kavlak', 'Affiliation': 'Pamukkale University, School of Physical Therapy and Rehabilitation, Denizli, Turkey. Electronic address: kavlake@hotmail.com.'}, {'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Turkucar', 'Affiliation': 'Dokuz Eylul University, Faculty of Medicine, Department of Pediatrics, Division of Pediatric Rheumatology, Izmir, Turkey. Electronic address: serkan_turkucar@hotmail.com.'}, {'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Bayraktar', 'Affiliation': 'Izmir Katip Celebi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Izmir, Turkey. Electronic address: ptdenislav@yahoo.com.'}, {'ForeName': 'Ceyhun', 'Initials': 'C', 'LastName': 'Acari', 'Affiliation': 'Dokuz Eylul University, Faculty of Medicine, Department of Pediatrics, Division of Pediatric Rheumatology, Izmir, Turkey. Electronic address: ceyhun_acari@hotmail.com.'}, {'ForeName': 'Erbil', 'Initials': 'E', 'LastName': 'Unsal', 'Affiliation': 'Dokuz Eylul University, Faculty of Medicine, Department of Pediatrics, Division of Pediatric Rheumatology, Izmir, Turkey. Electronic address: erbil.unsal@deu.edu.tr.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2021.102696'] 2304,33638647,Effect of a church-based intervention on abstinence communication among African-American caregiver-child dyads: the role of gender of caregiver and child.,"Parent-child sexual-health communication is critical. Religious involvement is important in many African-American families, but can be a barrier to sexual-health communication. We tested a theory-based, culturally tailored intervention to increase sexual-abstinence communication among church-attending African-American parent-child dyads. In a randomized controlled trial, 613 parent-child dyads were randomly assigned to one of three 3-session interventions: (i) faith-based abstinence-only; (ii) non-faith-based abstinence-only; or (iii) attention-matched health-promotion control. Data were collected pre- and post-intervention, and 3-, 6-, 12- and 18-months post-intervention. Generalized-estimating-equations Poisson-regression models revealed no differences in communication by intervention arm. However, three-way condition � sex-of-child � sex-of-parent interactions on children's reports of parent-child communication about puberty [IRR=0.065, 95% CI: (0.010, 0.414)], menstruation or wet dreams [IRR=0.103, 95% CI: (0.013, 0.825)] and dating [IRR=0.102, 95% CI: (0.016, 0.668)] indicated that the non-faith-based abstinence intervention's effect on increasing communication was greater with daughters than with sons, when the parent was the father. This study highlights the importance of considering parent and child gender in the efficacy of parent-child interventions and the need to tailor interventions to increase fathers' comfort with communication.",2021,Generalized-estimating-equations Poisson-regression models revealed no differences in communication by intervention arm.,"['613 parent-child dyads', 'African-American caregiver-child dyads', 'church-attending African-American parent-child dyads']","['church-based intervention', 'culturally tailored intervention', '3-session interventions: (i) faith-based abstinence-only; (ii) non-faith-based abstinence-only; or (iii) attention-matched health-promotion control']","['sexual-abstinence communication', 'abstinence communication', 'menstruation or wet dreams']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0562324', 'cui_str': 'Church'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]","[{'cui': 'C0562324', 'cui_str': 'Church'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0233931', 'cui_str': 'Nocturnal emission'}]",613.0,0.0304318,Generalized-estimating-equations Poisson-regression models revealed no differences in communication by intervention arm.,"[{'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Cederbaum', 'Affiliation': 'University of Southern California, Suzanne Dworak-Peck School of Social Work, 669 W. 34th Street, MRF 222, Los Angeles, CA 90089, USA.'}, {'ForeName': 'Soojong', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Annenberg School of Communication, 3901 Walnut Street, Suite 500, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'University of California, Davis, Department of Communication. One Shields Ave. Davis, CA 95616, USA.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Jemmott', 'Affiliation': 'University of Pennsylvania, Perelman School of Medicine and Annenberg School of Communication, 3901 Walnut Street, Suite 500, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Loretta S', 'Initials': 'LS', 'LastName': 'Jemmott', 'Affiliation': 'Drexel University, College of Nursing and Health Professions, 1601 Cherry Street, Philadelphia, PA 19102, USA.'}]",Health education research,['10.1093/her/cyab009'] 2305,33819444,Is there any priority between the alpha blockers on voiding functions after transrectal ultrasound guided prostate biopsy?,"OBJECTIVE Transrectal ultrasound-guided prostate biopsy is the gold standard in the diagnosis of prostate cancer. Major and minor complications may develop at varying rates after prostate biopsies, one of which is voiding impairment. This study aimed to evaluate whether all alpha1-blockers were effective in preventing voiding impairment after a transrectal ultrasound-guided prostate biopsy and if so, was one superior to the others. MATERIAL AND METHODS This study included 240 patients who underwent a transrectal ultrasound-guided 12-core prostate biopsy and were prospectively randomized. Of the patients, 40 received 10 mg alfuzosin, 40 received 4 mg doxazosin, 40 received 8 mg silodosin, 40 received 0.4 mg tamsulosin, and 40 received 5 mg terazosin beginning on the day before the biopsy and for the following 30 days. The international prostate symptom score (IPSS), maximal flow rate, and post-void residual urine were recorded in all the patients before the procedure and on post-biopsy days 7 and 30. All he patients were followed up and questioned about voiding difficulty and acute urinary retention after the procedure. RESULTS In all the alpha1-blocker groups, the IPSS and post-void residuals were statistically significantly lower, and the maximal flow rate was statistically significantly greater on post-biopsy days 7 and 30 compared with the baseline values (p<0.05). No patient in any of the alpha1-blocker groups developed acute urinary retention after the biopsy. CONCLUSION To prevent voiding impairment and deterioration in the quality of life after a prostate biopsy, preemptive therapy with alpha1-blockers may have a protective role, especially in patients with large prostate volumes.",2021,"In all the alpha1-blocker groups, the IPSS and post-void residuals were statistically significantly lower, and the maximal flow rate was statistically significantly greater on post-biopsy days 7 and 30 compared with the baseline values (p<0.05).","['240 patients who underwent a', 'patients with large prostate volumes']","['silodosin', 'doxazosin', 'terazosin', 'alpha blockers', 'transrectal ultrasound-guided 12-core prostate biopsy', 'tamsulosin', 'Transrectal ultrasound-guided prostate biopsy', 'alfuzosin', 'transrectal ultrasound-guided prostate biopsy']","['voiding impairment', 'acute urinary retention', 'international prostate symptom score (IPSS), maximal flow rate, and post-void residual urine', 'voiding functions', 'maximal flow rate', 'IPSS and post-void residuals']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0426732', 'cui_str': 'Large prostate'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]","[{'cui': 'C1870115', 'cui_str': 'silodosin'}, {'cui': 'C0114873', 'cui_str': 'Doxazosin'}, {'cui': 'C0076107', 'cui_str': 'Terazosin'}, {'cui': 'C0001641', 'cui_str': 'Alpha adrenergic receptor antagonist'}, {'cui': 'C0373345', 'cui_str': 'Transrectal ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0194804', 'cui_str': 'Biopsy of prostate'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C0051150', 'cui_str': 'alfuzosin'}]","[{'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0341742', 'cui_str': 'Acute retention of urine'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0278024', 'cui_str': 'Residual urine'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}]",240.0,0.0334222,"In all the alpha1-blocker groups, the IPSS and post-void residuals were statistically significantly lower, and the maximal flow rate was statistically significantly greater on post-biopsy days 7 and 30 compared with the baseline values (p<0.05).","[{'ForeName': 'Ozan', 'Initials': 'O', 'LastName': 'Efesoy', 'Affiliation': 'Department of Urology, Mersin City Training and Research Hospital, Mersin, Turkey.'}, {'ForeName': 'Barış', 'Initials': 'B', 'LastName': 'Saylam', 'Affiliation': 'Department of Urology, Mersin City Training and Research Hospital, Mersin, Turkey.'}, {'ForeName': 'Mesut', 'Initials': 'M', 'LastName': 'Tek', 'Affiliation': 'Department of Urology, Mersin University Faculty of Medicine, Mersin, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Bozlu', 'Affiliation': 'Department of Urology, Mersin University Faculty of Medicine, Mersin, Turkey.'}, {'ForeName': 'Erdem', 'Initials': 'E', 'LastName': 'Akbay', 'Affiliation': 'Department of Urology, Mersin University Faculty of Medicine, Mersin, Turkey.'}]",Turkish journal of urology,['10.5152/tud.2021.20509'] 2306,33652680,Action Observation Therapy for Upper Limb Recovery in Patients with Stroke: A Randomized Controlled Pilot Study.,"Due to the complexity of the interventions for upper limb recovery, at the moment there is a lack of evidence regarding innovative and effective rehabilitative interventions. Action Observation Training (AOT) constitutes a promising rehabilitative method to improve upper limb motor recovery in stroke patients. The aim of the present study was to evaluate the potential efficacy of AOT, both in upper limb recovery and in functional outcomes when compared to patients treated with task oriented training (TOT). Both treatments were added to traditional rehabilitative treatment. Thirty-two acute stroke patients at 15.6 days (±8.3) from onset, with moderate to severe upper limb impairment at baseline following their first-ever stroke, were enrolled and randomized into two groups: 16 in the experimental group (EG) and 16 in the control group (CG). The EG underwent 30 min sessions of AOT, and the CG underwent 30 min sessions of TOT. All participants received 20 sessions of treatment for four consecutive weeks (five days/week). The Fugl-Meyer Assessment for Upper Extremity (FMA-UE), Box and Block Test (BBT), Functional Independence Measure (FIM) and Modified Ashworth Scale (MAS) were administered at baseline (T 0 ) and at the end of treatment (T 1 ). No statistical differences were found at T 0 for inclusion criteria between the CG and EG, whereas both groups improved significantly at T 1 . After the treatment period, the rehabilitative gain was greater in the EG compared to the CG for FMA-UE and FIM (all p < 0.05). Our results suggest that AOT can contribute to increased motor recovery in subacute stroke patients with moderate to severe upper limb impairment in the early phase after stroke. The improvements presented in this article, together with the lack of adverse events, confirm that the use of AOT should be broadened out to larger pools of subacute stroke patients.",2021,"After the treatment period, the rehabilitative gain was greater in the EG compared to the CG for FMA-UE and FIM (all p < 0.05).","['Thirty-two acute stroke patients at 15.6 days (±8.3) from onset, with moderate to severe upper limb impairment at baseline following their first-ever stroke', 'stroke patients', 'Patients with Stroke', 'subacute stroke patients']","['Action Observation Training (AOT', 'Action Observation Therapy', 'AOT', 'task oriented training (TOT']","['motor recovery', 'Fugl-Meyer Assessment for Upper Extremity (FMA-UE), Box and Block Test (BBT), Functional Independence Measure (FIM) and Modified Ashworth Scale (MAS', 'rehabilitative gain']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}]","[{'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]",32.0,0.0194892,"After the treatment period, the rehabilitative gain was greater in the EG compared to the CG for FMA-UE and FIM (all p < 0.05).","[{'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Mancuso', 'Affiliation': 'Physical and Rehabilitative Medicine Unit, NHS-USL Tuscany South-Est, Via Senese 169, 58100 Grosseto (GR), Italy.'}, {'ForeName': 'Serena Di', 'Initials': 'SD', 'LastName': 'Tondo', 'Affiliation': 'Tuscany Rehabilitation Clinic, Montevarchi, Piazza del Volontariato 2, Montevarchi, 52025 Arezzo (AR), Italy.'}, {'ForeName': 'Enza', 'Initials': 'E', 'LastName': 'Costantini', 'Affiliation': 'Physical and Rehabilitative Medicine Unit, NHS-USL Tuscany South-Est, Via Senese 169, 58100 Grosseto (GR), Italy.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Damora', 'Affiliation': 'Tuscany Rehabilitation Clinic, Montevarchi, Piazza del Volontariato 2, Montevarchi, 52025 Arezzo (AR), Italy.'}, {'ForeName': 'Patrizio', 'Initials': 'P', 'LastName': 'Sale', 'Affiliation': ""Sant'Isidoro Hospital, FERB Onlus, Via Ospedale 34, 24069 Trescore Balneario (BG), Italy.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Abbruzzese', 'Affiliation': 'Tuscany Rehabilitation Clinic, Montevarchi, Piazza del Volontariato 2, Montevarchi, 52025 Arezzo (AR), Italy.'}]",Brain sciences,['10.3390/brainsci11030290'] 2307,33647599,The EMA review of trastuzumab emtansine (T-DM1) for the adjuvant treatment of adult patients with HER2-positive early breast cancer.,"Trastuzumab emtansine (T-DM1) is an antibody-drug conjugate of trastuzumab [a monoclonal antibody against human epidermal growth factor receptor 2 (HER2)] and DM1 (an inhibitor of tubulin polymerisation). It was initially approved in the European Union for the treatment of adult patients with HER2-positive unresectable locally advanced or metastatic breast cancer (BC) who had previously received trastuzumab and taxanes. On 18 December 2019, a variation of the marketing authorisation was approved extending this use to the adjuvant therapy of adult patients with HER2-positive early BC who have residual invasive disease in the breast and/or lymph nodes after neoadjuvant taxane-based and HER2-targeted therapy. A phase III randomised, multicentre, open-label trial compared T-DM1 with trastuzumab as adjuvant therapy in patients with HER2-positive early BC who had received preoperative chemotherapy and HER2-targeted therapy followed by surgery, with a finding of invasive residual disease in the breast and/or axillary lymph nodes. The study met its primary endpoint by showing an increased 3-year invasive disease-free survival rate in the T-DM1 arm (88.3%) compared with the trastuzumab arm (77.0%), with an unstratified hazard ratio of 0.50 (95% confidence interval: 0.39-0.64). There was a higher incidence of hepatotoxicity (37.3% versus 10.6%), thrombocytopenia (28.5% versus 2.4%), peripheral neuropathy (32.3% versus 16.9%), haemorrhage (29.2% versus 9.6%) and pulmonary toxicity (2.8% versus 0.8%) in the T-DM1 arm compared with the control arm. The aim of this manuscript was to summarise the scientific review of the application leading to regulatory approval of this additional indication in the European Union.",2021,"There was a higher incidence of hepatotoxicity (37.3% versus 10.6%), thrombocytopenia (28.5% versus 2.4%), peripheral neuropathy (32.3% versus 16.9%), haemorrhage (29.2% versus 9.6%) and pulmonary toxicity (2.8% versus 0.8%) in the T-DM1 arm compared with the control arm.","['adult patients with HER2-positive early breast cancer', 'adult patients with HER2-positive early BC who have residual invasive disease in the breast and/or lymph nodes after neoadjuvant taxane-based and HER2-targeted therapy', 'adult patients with HER2-positive unresectable locally advanced or metastatic breast cancer (BC) who had previously received', 'patients with HER2-positive early BC who had received preoperative chemotherapy and HER2-targeted therapy followed by surgery, with a finding of invasive residual disease in the breast and/or axillary lymph nodes']","['Trastuzumab emtansine (T-DM1', 'T-DM1 with trastuzumab', 'trastuzumab and taxanes', 'trastuzumab emtansine (T-DM1']","['pulmonary toxicity', 'thrombocytopenia', 'hepatotoxicity', 'peripheral neuropathy', 'haemorrhage', '3-year invasive disease-free survival rate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumour'}, {'cui': 'C0729594', 'cui_str': 'Axillary lymph node group'}]","[{'cui': 'C2935436', 'cui_str': 'ado-trastuzumab emtansine'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0215136', 'cui_str': 'taxane'}]","[{'cui': 'C0919924', 'cui_str': 'Pulmonary toxicity'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",,0.0845863,"There was a higher incidence of hepatotoxicity (37.3% versus 10.6%), thrombocytopenia (28.5% versus 2.4%), peripheral neuropathy (32.3% versus 16.9%), haemorrhage (29.2% versus 9.6%) and pulmonary toxicity (2.8% versus 0.8%) in the T-DM1 arm compared with the control arm.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Delgado', 'Affiliation': 'Oncology and Haematology Office, European Medicines Agency (EMA), Amsterdam, The Netherlands; Department of Haematology, Hospital Clinic, Barcelona, Spain. Electronic address: julio.delgado@ema.europa.eu.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Vleminckx', 'Affiliation': 'Oncology and Haematology Office, European Medicines Agency (EMA), Amsterdam, The Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sarac', 'Affiliation': 'Danish Medicines Agency, Copenhagen, Denmark; Committe for Medicinal Products for Human Use (CHMP), EMA, Amsterdam, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sosa', 'Affiliation': 'Danish Medicines Agency, Copenhagen, Denmark.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bergh', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institute and Breast Cancer Centre, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Giuliani', 'Affiliation': 'The Clatterbridge Cancer Centre, Liverpool, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Enzmann', 'Affiliation': 'Committe for Medicinal Products for Human Use (CHMP), EMA, Amsterdam, The Netherlands; Bundesinstitut fur Arzneimittel und Medizinprodukte, Bonn, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Pignatti', 'Affiliation': 'Oncology and Haematology Office, European Medicines Agency (EMA), Amsterdam, The Netherlands.'}]",ESMO open,['10.1016/j.esmoop.2021.100074'] 2308,33657762,Effect of neurogenic acupoint cupping on high sensitive C-reactive protein and pain perception in female chronic pelvic pain: A randomized controlled trial.,"OBJECTIVES To determine the effect of neurogenic acupoint dry cupping therapy on high sensitive C-reactive protein (hs-CRP) level, pain perception & intensity, and life impact of pelvic pain in women with chronic pelvic pain (CPP), with regard to the biological and neurophysiological impacts of dry cupping on acupoint. METHODS Thirty women with CPP were randomly divided into two equal groups; the study group received dry cupping on neurogenic acupoints plus lifestyle modifications for 8 weeks (n=15), while the control group received only lifestyle modifications for 8 weeks (n=15). Women were assessed pre- and post-rehabilitation program with the hs-CRP blood test, the short-form McGill Pain Questionnaire (SF-MPQ), and the pelvic pain impact questionnaire (PPIQ). RESULTS Comparing both groups post-treatment revealed that there were significant reductions in levels of hs-CRP, and scores of SF-MPQ & PPIQ (p<0.05) in the study group compared with the control group. Also, there were significant positive correlations between hs-CRP and both SF-MPQ ""Visual Analogue Scale (VAS), Present Pain Intensity (PPI) index & Pain Rating Index (PRI)"" and PPIQ (p<0.05). CONCLUSION Neurogenic acupoint cupping therapy had significantly improving effects on the degree of inflammation, pain perception & intensity, and life impact of pelvic pain in women with CPP.",2021,"Comparing both groups post-treatment revealed that there were significant reductions in levels of hs-CRP, and scores of SF-MPQ & PPIQ (p<0.05) in the study group compared with the control group.","['female chronic pelvic pain', 'women with CPP', 'women with chronic pelvic pain (CPP', 'Thirty women with CPP']","['neurogenic acupoint dry cupping therapy', 'Neurogenic acupoint cupping therapy', 'dry cupping on neurogenic acupoints plus lifestyle modifications', 'control group received only lifestyle modifications', 'neurogenic acupoint cupping']","['SF-MPQ ""Visual Analogue Scale (VAS), Present Pain Intensity (PPI) index & Pain Rating Index (PRI)"" and PPIQ (p<0.05', 'degree of inflammation, pain perception & intensity, and life impact of pelvic pain', 'levels of hs-CRP, and scores of SF-MPQ & PPIQ', 'high sensitive C-reactive protein (hs-CRP) level, pain perception & intensity, and life impact of pelvic pain', 'McGill Pain Questionnaire (SF-MPQ), and the pelvic pain impact questionnaire (PPIQ']","[{'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C5197695', 'cui_str': 'Cupping Treatment'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",30.0,0.0509402,"Comparing both groups post-treatment revealed that there were significant reductions in levels of hs-CRP, and scores of SF-MPQ & PPIQ (p<0.05) in the study group compared with the control group.","[{'ForeName': 'Khadiga S', 'Initials': 'KS', 'LastName': 'Abdulaziz', 'Affiliation': ""Department of Physical Therapy For Woman's Health, Faculty of Physical Therapy, Cairo University, Egypt.""}, {'ForeName': 'Rehab', 'Initials': 'R', 'LastName': 'Tareq Mohamad', 'Affiliation': 'Department of Physiotherapy, Family Medicine Unit, Health Affairs Directorate - 6th Of October (Ministry of health), Giza, Egypt.'}, {'ForeName': 'Lama', 'Initials': 'L', 'LastName': 'Saad El-Din Mahmoud', 'Affiliation': 'Department of Physical Therapy For Neuromuscular Disorders and its surgery, Faculty of Physical Therapy, October 6 University, Egypt.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Abdel Azim Ramzy', 'Affiliation': 'Department of Clinical and Chemical Pathology, Faculty of medicine, Cairo University, Egypt.'}, {'ForeName': 'Doaa A', 'Initials': 'DA', 'LastName': 'Osman', 'Affiliation': ""Department of Physical Therapy For Woman's Health, Faculty of Physical Therapy, Cairo University, Egypt.""}]",Journal of musculoskeletal & neuronal interactions,[] 2309,33657760,Multimodal analgesia protocol for pain management after total knee arthroplasty: comparison of three different regional analgesic techniques.,"OBJECTIVES To evaluate three different analgesic techniques, continuous epidural analgesia (EA), continuous intra-articular (IA) infusion analgesia and continuous femoral nerve block (FNB) in postoperative pain management, length of hospital stay (LOS), and time of patient mobilization after total knee arthroplasty (TKA). METHODS Seventy-two patients undergoing TKA were randomly allocated into three groups according to the analgesic technique used for postoperative pain management. Group EA patients received epidural analgesia (control group), group IA received intra-articular infusion and group FNB received femoral nerve block. RESULTS Upon analyzing the Numerical Rating Scale (NRS) scores at rest, at passive and active movement, up to 3 days postoperatively, we observed no statistically significant differences at any time point among the three groups. Similarly, no association among these analgesic techniques (EA, IA, FNB) was revealed regarding LOS. However, significant differences emerged concerning the time of mobilization. Patients who received IA achieved earlier mobilization compared to FNB and EA. CONCLUSIONS Both IA and FNB generate similar analgesic effect with EA for postoperative pain management after TKA. However, IA appears to be significantly more effective in early mobilization compared to EA and FNB. Finally, no clinically important differences could be detected regarding LOS among the techniques studied.",2021,"up to 3 days postoperatively, we observed no statistically significant differences at any time point among the three groups.","['pain management after total knee arthroplasty', 'Seventy-two patients undergoing TKA']","['continuous epidural analgesia (EA), continuous intra-articular (IA) infusion analgesia and continuous femoral nerve block (FNB', 'epidural analgesia (control group), group IA received intra-articular infusion and group FNB received femoral nerve block', 'Multimodal analgesia protocol', 'analgesic technique used for postoperative pain management']","['analgesic techniques (EA, IA, FNB', 'Numerical Rating Scale (NRS) scores', 'time of mobilization', 'postoperative pain management, length of hospital stay (LOS), and time of patient mobilization after total knee arthroplasty (TKA']","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0412784', 'cui_str': 'Analgesic technique'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0412784', 'cui_str': 'Analgesic technique'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]",72.0,0.0639441,"up to 3 days postoperatively, we observed no statistically significant differences at any time point among the three groups.","[{'ForeName': 'Georgios Z', 'Initials': 'GZ', 'LastName': 'Karpetas', 'Affiliation': 'Department of Anesthesiology and Critical Care, University Hospital of Patras, Patras, Greece.'}, {'ForeName': 'Maria K', 'Initials': 'MK', 'LastName': 'Spyraki', 'Affiliation': 'Department of Anesthesiology and Critical Care, University Hospital of Patras, Patras, Greece.'}, {'ForeName': 'Savvas I', 'Initials': 'SI', 'LastName': 'Giakoumakis', 'Affiliation': 'Department of Orthopedic Surgery, University Hospital of Patras, Patras, Greece.'}, {'ForeName': 'Fotini G', 'Initials': 'FG', 'LastName': 'Fligou', 'Affiliation': 'Department of Anesthesiology and Critical Care, University Hospital of Patras, Patras, Greece.'}, {'ForeName': 'Panagiotis D', 'Initials': 'PD', 'LastName': 'Megas', 'Affiliation': 'Department of Orthopedic Surgery, University Hospital of Patras, Patras, Greece.'}, {'ForeName': 'Gregorios S', 'Initials': 'GS', 'LastName': 'Voyagis', 'Affiliation': 'Department of Anesthesiology and Critical Care, University Hospital of Patras, Patras, Greece.'}, {'ForeName': 'Elias C', 'Initials': 'EC', 'LastName': 'Panagiotopoulos', 'Affiliation': 'Department of Orthopedic Surgery, University Hospital of Patras, Patras, Greece.'}]",Journal of musculoskeletal & neuronal interactions,[] 2310,33657757,Suit therapy versus whole-body vibration on bone mineral density in children with spastic diplegia.,"OBJECTIVES Osteoporosis because of physical inactivity is one of the major complications associated with neuromuscular disorders. The study aimed to compare using Suit therapy and whole-body vibration in addition to selected physical therapy program to improve Bone Mineral Density in children with cerebral palsy of spastic diplegia. METHODS Forty-six patients were classified randomly into two equal groups. Patients in the group (A) engaged in a selected physical therapy program, also besides, suit therapy training program while those in the group (B) received the same selected physical therapy program received by group (A) in addition to the whole-body vibration training program. The treatment programs were conducted three times per week for twelve successive weeks. Measurements obtained included bone mineral density at the lumbar spine as well as at the femoral neck. These measures were recorded pre- and post-treatment. RESULTS There was a significant improvement in favor of the whole-body Vibration group. Bone mineral density improved significantly at both the lumbar spine (P=.038) and the femoral neck (P=.005) in the WBV group as compared to the Suit therapy group. CONCLUSIONS Whole-body vibration is effective in improving Bone Mineral Density rather than Suit therapy in children with cerebral palsy of spastic diplegia.",2021,"Bone mineral density improved significantly at both the lumbar spine (P=.038) and the femoral neck (P=.005) in the WBV group as compared to the Suit therapy group. ","['children with cerebral palsy of spastic diplegia', 'Forty-six patients', 'children with spastic diplegia']","['Suit therapy and whole-body vibration in addition to selected physical therapy program', 'Suit therapy versus whole-body vibration', 'selected physical therapy program, also besides, suit therapy training program while those in the group (B) received the same selected physical therapy program received by group (A) in addition to the whole-body vibration training program']","['Bone mineral density', 'bone mineral density', 'femoral neck', 'Bone Mineral Density']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0023882', 'cui_str': 'Spastic diplegia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}]",46.0,0.00961162,"Bone mineral density improved significantly at both the lumbar spine (P=.038) and the femoral neck (P=.005) in the WBV group as compared to the Suit therapy group. ","[{'ForeName': 'Amira E', 'Initials': 'AE', 'LastName': 'El-Bagalaty', 'Affiliation': 'Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Egypt.'}, {'ForeName': 'Marwa M I', 'Initials': 'MMI', 'LastName': 'Ismaeel', 'Affiliation': 'Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Egypt.'}]",Journal of musculoskeletal & neuronal interactions,[] 2311,33632925,"FDA Approval Summary: Nivolumab with Ipilimumab and Chemotherapy for Metastatic Non-small Cell Lung Cancer, A Collaborative Project Orbis Review.","On May 26, 2020, the FDA approved nivolumab with ipilimumab and two cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or anaplastic lymphoma kinase ( ALK ) genomic tumor aberrations. The approval was based on results from Study CA2099LA (CheckMate 9LA), an open-label trial in which 719 patients with NSCLC were randomized to receive nivolumab with ipilimumab and two cycles of chemotherapy ( n = 361) or four cycles of platinum-doublet chemotherapy ( n = 358). Overall survival (OS) was improved for patients who received nivolumab with ipilimumab and chemotherapy, with a median OS of 14.1 months [95% confidence interval (CI), 13.2-16.2] compared with 10.7 months (95% CI, 9.5-12.5) for patients who received chemotherapy (HR, 0.69; 96.71% CI, 0.55-0.87; P = 0.0006). Progression-free survival and overall response rate per blinded independent central review were also statistically significant. This was the first NSCLC application reviewed under FDA's Project Orbis, in collaboration with Singapore's Health Sciences Authority, Australia's Therapeutic Goods Administration, and Health Canada. The benefit-risk analysis supports FDA's approval of nivolumab with ipilimumab and chemotherapy.",2021,"Overall survival (OS) was improved for patients who received nivolumab with ipilimumab and chemotherapy, with a median OS of 14.1 months (95% CI: 13.2, 16.2) compared to 10.7 months (95% CI: 9.5, 12.5) for patients who received chemotherapy (HR 0.69; 96.71% CI: 0.55, 0.87; p = 0.0006).","['719 patients with NSCLC', 'patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations']","['nivolumab with ipilimumab and two cycles of chemotherapy (n=361) or four cycles of platinum-doublet chemotherapy', 'platinum-doublet chemotherapy', 'Ipilimumab and Chemotherapy']","['Progression-free survival (PFS) and overall response rate (ORR) per blinded independent central review (BICR', 'Overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0278517', 'cui_str': 'Non-small cell lung cancer recurrent'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0252409', 'cui_str': 'ALK Tyrosine Kinase Receptor'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",719.0,0.213117,"Overall survival (OS) was improved for patients who received nivolumab with ipilimumab and chemotherapy, with a median OS of 14.1 months (95% CI: 13.2, 16.2) compared to 10.7 months (95% CI: 9.5, 12.5) for patients who received chemotherapy (HR 0.69; 96.71% CI: 0.55, 0.87; p = 0.0006).","[{'ForeName': 'Paz J', 'Initials': 'PJ', 'LastName': 'Vellanki', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. paz.vellanki@fda.hhs.gov.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Mulkey', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Adnan A', 'Initials': 'AA', 'LastName': 'Jaigirdar', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Rodriguez', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Yibo', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Howe', 'Affiliation': 'Health Canada, Ottawa, Ontario, Canada.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Health Canada, Ottawa, Ontario, Canada.'}, {'ForeName': 'Qiuyi', 'Initials': 'Q', 'LastName': 'Choo', 'Affiliation': 'Health Sciences Authority, Singapore, Republic of Singapore.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Golding', 'Affiliation': 'Therapeutic Goods Administration, Canberra, Australia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Mansell', 'Affiliation': 'Therapeutic Goods Administration, Canberra, Australia.'}, {'ForeName': 'Kwadwo', 'Initials': 'K', 'LastName': 'Korsah', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'Spillman', 'Affiliation': 'Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'R Angelo', 'Initials': 'RA', 'LastName': 'de Claro', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pazdur', 'Affiliation': 'Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Beaver', 'Affiliation': 'Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Harpreet', 'Initials': 'H', 'LastName': 'Singh', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-4338'] 2312,33632921,"Methods to Optimize Recruitment, Participation, and Retention Among Vulnerable Individuals Participating in a Longitudinal Clinical Trial.","Low-income and ethnic/racial minority adults do not often participate in research or may face unique barriers when participating in research, which delays and impedes medical advances for this vulnerable population. This article describes in detail the evidenced-based methods used to enhance recruitment, participation, and retention in a clinical trial at a center serving ethnic/racial minorities and low-income individuals. The article details the partnership with a community outreach center and describes the duties and impact of a community liaison to enhance recruitment, participation, and retention in a randomized controlled trial with a 6-month follow-up. Of the 246 individuals initially recruited for screening, 80 did not meet inclusion criteria with the most common reason for disqualification being meeting criteria for substance use disorder ( n = 44). One hundred sixty-six participants qualified for participation. The majority of participants identified as African American ( n = 127, 77.1%) and reported an annual individual income under $10,000 ( n = 121 (74.2%). Forty-five percent of the sample completed the requested number of sessions (i.e., 12). Sixty-three percent of participants completed post intervention assessments and 42% completed 6-month follow-up data collection. The participation and retention numbers in this study appear higher than typical participation and retention rates in longitudinal studies with similar populations. The methods and lessons learned may be useful for other clinical trials that recruit vulnerable populations and wish to enhance participation, engagement, and retention.",2021,"The majority of participants identified as African American ( n = 127, 77.1%) and reported an annual individual income under $10,000 ( n = 121 (74.2%).","['participants identified as African American ( n = 127, 77.1%) and reported an annual individual income under $10,000 ( n = 121 (74.2', 'Forty-five percent of the sample completed the requested number of sessions (i.e., 12', 'One hundred sixty-six participants qualified for participation', '246 individuals initially recruited for screening, 80 did not meet inclusion criteria with the most common reason for disqualification being meeting criteria for substance use disorder ( n = 44']",[],[],"[{'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0557168', 'cui_str': 'Individual income'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}]",[],[],166.0,0.133775,"The majority of participants identified as African American ( n = 127, 77.1%) and reported an annual individual income under $10,000 ( n = 121 (74.2%).","[{'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Doran', 'Affiliation': 'School of Nursing, University of Maryland, Baltimore, MD kdoran@umaryland.edu.'}, {'ForeName': 'Anahi', 'Initials': 'A', 'LastName': 'Collado', 'Affiliation': 'Department of Psychology, University of Kansas, Lawrence, KS.'}, {'ForeName': 'Hailey', 'Initials': 'H', 'LastName': 'Taylor', 'Affiliation': 'Department of Psychology, University of Kansas, Lawrence, KS.'}, {'ForeName': 'Julia W', 'Initials': 'JW', 'LastName': 'Felton', 'Affiliation': 'Division of Public Health, Michigan State University, Flint, MI.'}, {'ForeName': 'Kayla N', 'Initials': 'KN', 'LastName': 'Tormohlen', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Yi', 'Affiliation': 'Department of Psychology, University of Kansas, Lawrence, KS.'}]",Research and theory for nursing practice,['10.1891/RTNP-D-19-00039'] 2313,33637367,"Re: Jean F.P. Lestingi, Giuliano B. Guglielmetti, Quoc-Dien Trinh, et al. Extended Versus Limited Pelvic Lymph Node Dissection During Radical Prostatectomy for Intermediate- and High-risk Prostate Cancer: Early Oncological Outcomes from a Randomized Phase 3 Trial. Eur Urol. In press. https://doi.org/10.1016/j.eururo.2020.11.040: Time for a Change? Clinically Meaningful Reasons Why We Will Continue Performing Extended Pelvic Lymph Node Dissection in Selected Patients with Prostate Cancer.",,2021,,"['for Intermediate- and High-risk Prostate Cancer', 'Selected Patients with Prostate Cancer']","['Pelvic Lymph Node Dissection During Radical Prostatectomy', 'https://doi.org/10.1016/j.eururo.2020.11.040']",[],"[{'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0193883', 'cui_str': 'Pelvic lymphadenectomy'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}]",[],,0.0340046,,"[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Briganti', 'Affiliation': 'Division of Oncology/Unit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Gandaglia', 'Affiliation': 'Division of Oncology/Unit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy. Electronic address: giorgio.gandaglia@gmail.com.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Graefen', 'Affiliation': 'Martini-Klinik Prostate Cancer Center, University Hospital Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Joniau', 'Affiliation': 'Department of Urology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'R Jeffrey', 'Initials': 'RJ', 'LastName': 'Karnes', 'Affiliation': 'Department of Urology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Montorsi', 'Affiliation': 'Division of Oncology/Unit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy.'}]",European urology,['10.1016/j.eururo.2021.02.024'] 2314,33636163,Novel method for quantification of lipoprotein(a)-cholesterol: implications for improving accuracy of LDL-C measurements.,"Current methods for determining ""LDL-C"" in clinical practice measure the cholesterol content of both LDL and lipoprotein(a) [Lp(a)-C]. We developed a high-throughput, sensitive, and rapid method to quantitate Lp(a)-C and improve the accuracy of LDL-C by subtracting for Lp(a)-C (LDL-C corr ). Lp(a)-C is determined following isolation of the Lp(a) on magnetic beads linked to monoclonal antibody LPA4 recognizing apolipoprotein(a). This Lp(a)-C assay does not detect cholesterol in plasma samples lacking Lp(a) and is linear up to 747 nM Lp(a). To validate this method clinically over a wide range of Lp(a) (9.0-822.8 nM), Lp(a)-C and LDL-C corr were determined in 21 participants receiving an Lp(a)-specific lowering antisense oligonucleotide and in eight participants receiving placebo at baseline, at 13 weeks during peak drug effect, and off drug. In the groups combined, Lp(a)-C ranged from 0.6 to 35.0 mg/dl and correlated with Lp(a) molar concentration (r = 0.76; P < 0.001). However, the percent Lp(a)-C relative to Lp(a) mass varied from 5.8% to 57.3%. Baseline LDL-C corr was lower than LDL-C [mean (SD), 102.2 (31.8) vs. 119.2 (32.4) mg/dl; P < 0.001] and did not correlate with Lp(a)-C. It was demonstrated that three commercially available ""direct LDL-C"" assays also include measures of Lp(a)-C. In conclusion, we have developed a novel and sensitive method to quantitate Lp(a)-C that provides insights into the Lp(a) mass/cholesterol relationship and may be used to more accurately report LDL-C and reassess its role in clinical medicine.",2021,"In the groups combined, Lp(a)-C ranged from 0.6-35.0 mg/dL and correlated with Lp(a) molar concentration (r=0.76, p<0.001).",['21 participants receiving an Lp(a)-specific lowering ASO and in 8 participants receiving'],"['Lp(a', 'lipoprotein', 'Lp(a)-C', 'placebo']","['Baseline LDL-C corr', 'Lp(a) molar concentration']","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0003436', 'cui_str': 'Antistreptolysin O'}]","[{'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0457929', 'cui_str': 'Substance concentration'}]",21.0,0.033616,"In the groups combined, Lp(a)-C ranged from 0.6-35.0 mg/dL and correlated with Lp(a) molar concentration (r=0.76, p<0.001).","[{'ForeName': 'Calvin', 'Initials': 'C', 'LastName': 'Yeang', 'Affiliation': 'Vascular Medicine Program, Sulpizio Cardiovascular Center, Division of Cardiology, University of California San Diego, La Jolla, CA, USA. Electronic address: cyeang@health.ucsd.edu.'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Witztum', 'Affiliation': 'Division of Endocrinology and Metabolism, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Sotirios', 'Initials': 'S', 'LastName': 'Tsimikas', 'Affiliation': 'Vascular Medicine Program, Sulpizio Cardiovascular Center, Division of Cardiology, University of California San Diego, La Jolla, CA, USA. Electronic address: stsimikas@health.ucsd.edu.'}]",Journal of lipid research,['10.1016/j.jlr.2021.100053'] 2315,33638931,Effects of simvastatin on tissue factor pathway of blood coagulation in STATCOPE (Simvastatin in the prevention of COPD exacerbations) trial.,"BACKGROUND Statins are widely used to lower lipids and reduce cardiovascular events. In vitro studies and small studies in patients with hyperlipidemias show statins inhibit tissue factor (TF) and blood coagulation mechanisms. We assessed the effects of simvastatin on TF and coagulation biomarkers in patients entered in STATCOPE, a multicenter, randomized, placebo-controlled trial of simvastatin (40 mg daily) versus placebo on exacerbation rates in patients with chronic obstructive pulmonary disease (COPD). METHODS In 227 patients (114 simvastatin, 113 placebo; mean [± standard error of the mean] age 62 ± 0.53 years, 44.5% women) we measured (baseline, and 6 and 12 months): whole blood membrane TF-procoagulant activity (TF-PCA) and plasma factors VIIa, VII, VIII, fibrinogen, TF antigen, tissue factor pathway inhibitor (TFPI), thrombin-antithrombin complexes (TAT), and D-dimer. We excluded patients with diabetes, cardiovascular disease, and those taking or requiring a statin. RESULTS In the statin group, there was a small increase in TF-PCA (from 25.18 ± 1.08 to 30.36 ± 1.10 U/ml; p = .03) over 12 months; factors VIIa and VIII, fibrinogen, TAT, and D-dimer did not change. Plasma TFPI (from 52.4 ± 1.75 to 44.7 ± 1.78 ng/ml; p < .0001) and FVIIC (1.23 ± 0.04 to 1.15 ± 0.03 U/ml; p = .03) decreased and correlated with total cholesterol levels. No changes in biomarkers were observed with placebo. CONCLUSIONS In contrast to previous studies on statins, in COPD patients without diabetes, cardiovascular disease, or requiring a statin treatment, simvastatin (40 mg per day) did not decrease TF or factors VIIa and VIII, fibrinogen, TAT, or D-dimer. The decreases in TFPI and factor VII reflect the decrease in serum lipids.",2021,Plasma TFPI (from 52.4±1.75 to 44.7±1.78 ng/mL; p< 0.0001) and FVIIC (1.23±0.04 to 1.15±0.03 U/mL; p=0.03) decreased and correlated with total cholesterol levels.,"['COPD Exacerbations', 'COPD patients without diabetes, cardiovascular disease or requiring a statin treatment', 'patients with hyperlipidemias', 'patients with chronic obstructive pulmonary disease (COPD', '227 patients (114 simvastatin; 113 placebo; mean (±SEM) age 62 ± 0.53 years, 44.5 % women', 'patients with diabetes, cardiovascular disease and those taking or requiring a statin']","['simvastatin', 'placebo', 'Simvastatin']","['blood membrane TF-procoagulant activity (TF-PCA) and plasma factors VIIa, VII, VIII, fibrinogen, TF antigen, tissue factor pathway inhibitor (TFPI), thrombin-antithrombin complexes (TAT) and D-dimer', 'TF-PCA', 'FVIIC', 'Plasma TFPI', 'TF and coagulation biomarkers', 'total cholesterol levels', 'TFPI and factor VII', 'exacerbation rates', 'TF or factors VIIa and VIII, fibrinogen, TAT or D-dimer', 'Tissue Factor Pathway of Blood Coagulation', 'factors VIIa and VIII, fibrinogen, TAT and D-dimer', 'serum lipids']","[{'cui': 'C3508933', 'cui_str': 'Chronic obstructive pulmonary disease exacerbation'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0040048', 'cui_str': 'Thromboplastin'}, {'cui': 'C0030131', 'cui_str': 'p-Chloramphetamine'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0015505', 'cui_str': 'Factor VIIa'}, {'cui': 'C0445385', 'cui_str': 'VII'}, {'cui': 'C0445599', 'cui_str': 'VIII'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0164707', 'cui_str': 'Tissue factor pathway inhibitor'}, {'cui': 'C0052128', 'cui_str': 'Thrombin-antithrombin complex'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015502', 'cui_str': 'factor VII'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}]",227.0,0.25184,Plasma TFPI (from 52.4±1.75 to 44.7±1.78 ng/mL; p< 0.0001) and FVIIC (1.23±0.04 to 1.15±0.03 U/mL; p=0.03) decreased and correlated with total cholesterol levels.,"[{'ForeName': 'A Koneti', 'Initials': 'AK', 'LastName': 'Rao', 'Affiliation': 'Sol Sherry Thrombosis Research Center, Department of Medicine, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Fabiola', 'Initials': 'F', 'LastName': 'Del Carpio-Cano', 'Affiliation': 'Sol Sherry Thrombosis Research Center, Department of Medicine, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Sumalaxmi', 'Initials': 'S', 'LastName': 'Janapati', 'Affiliation': 'Sol Sherry Thrombosis Research Center, Department of Medicine, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Huaqing', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Clinical Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Voelker', 'Affiliation': 'Department of Biostatistics, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Xiaoning', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'Department of Clinical Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Criner', 'Affiliation': 'Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of thrombosis and haemostasis : JTH,['10.1111/jth.15282'] 2316,33638928,Assessing the effectiveness of the combination therapy with fractional Er-YAG laser and platelet-rich plasma in treatment of periorbital dark circles patients: A clinical trial.,"BACKGROUND Numerous therapeutic techniques for periorbital hyperpigmentation have been suggested. AIM In this comparative intrapatient study, the effectiveness of combination therapy included fractional Er: YAG laser and autologous platelet-rich plasma (PRP) compared to Er: YAG laser in periorbital hyperpigmentation treatment. PATIENTS/METHODS Thirty-two patients were enrolled. The right periorbital sides of patients received combination of Er: YAG laser and autologous platelet-rich plasma (PRP) and the left side received Er: YAG laser (three sessions with 4 weeks' intervals). PRP was used in two ways included injection and topical. Patients were evaluated by biometric characteristics, patients, and physician assessments. Also, the patient's satisfaction was assessed and side effects were evaluated. RESULTS The mexameter results showed that the melanin content in the right side of the periorbital of the patients was significantly decreased compared to left side. Also, significant increase was observed in the skin lightness of the right side in compare to left. The visioface results showed the decrease in the percent change of the color and wrinkle in both sides, but in the right side these changes were significantly more than left side. The patients and physician assessment confirmed the measured results. CONCLUSION Combination of Er: YAG laser and PRP is significantly effective for periorbital hyperpigmentation.",2021,The visioface results showed the decrease in the percent change of the color and wrinkle in both sides but in the right side this changes were significantly more than left side.,"['periorbital hyperpigmentation treatment', 'periorbital dark circles patients', 'Thirty-two patients were enrolled']","['fractional Er-YAG laser and Platelet Rich Plasma (PRP', 'combination of Er: YAG laser and autologous platelet-rich plasma (PRP) and the left side received Er: YAG laser', 'PRP', 'Er: YAG laser and PRP', 'fractional Er: YAG laser and autologous platelet-rich plasma (PRP) compared to Er: YAG laser']","['skin lightness', 'color and wrinkle']","[{'cui': 'C0230064', 'cui_str': 'Periorbital'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332582', 'cui_str': 'Dark color'}, {'cui': 'C0231706', 'cui_str': 'Circling gait'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450357', 'cui_str': '32'}]","[{'cui': 'C0457903', 'cui_str': 'Erbium:YAG laser device'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0205091', 'cui_str': 'Left'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}]",32.0,0.0145351,The visioface results showed the decrease in the percent change of the color and wrinkle in both sides but in the right side this changes were significantly more than left side.,"[{'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Nilforoushzadeh', 'Affiliation': 'Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Heidari-Kharaji', 'Affiliation': 'Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shiva', 'Initials': 'S', 'LastName': 'Alavi', 'Affiliation': 'Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Mahmoudbeyk', 'Affiliation': 'Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Torkamaniha', 'Affiliation': 'Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Aisan', 'Initials': 'A', 'LastName': 'Peyrovan', 'Affiliation': 'Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Nouri', 'Affiliation': 'Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sona', 'Initials': 'S', 'LastName': 'Zare', 'Affiliation': 'Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}]",Journal of cosmetic dermatology,['10.1111/jocd.14036'] 2317,33637110,"Narrative Exposure Therapy versus treatment as usual in a sample of trauma survivors who live under ongoing threat of violence in Rio de Janeiro, Brazil: study protocol for a randomised controlled trial.","BACKGROUND One in three individuals who live in Rio de Janeiro experience a traumatic event within a period of 12 months. In the favelas particularly, trauma exposure is ongoing. Psychological sequalae include posttraumatic stress disorder (PTSD), depression and other mental disorders. Trauma-focused therapy approaches have emerged as the treatment of choice when the dangerous events are over, but symptoms have remained for an extended time period. Ideally, the victim is in a safe context during treatment. However, frequently, survivors cannot escape from situations characterised by ongoing threat and traumatic stress. The aim of this study is to research the effectiveness of Narrative Exposure Therapy in a sample of PTSD patients living under these conditions. METHODS Individuals fulfilling the criteria for PTSD and who live in conditions of ongoing community violence (i.e. in the favelas) in Rio de Janeiro will be randomly assigned to one of two treatments: Narrative Exposure Therapy (NET) or treatment as usual (TAU). Clinical endpoints will be primarily PTSD and secondarily symptoms of shutdown dissociation, depression, substance involvement  and functionality. DISCUSSION Effective treatment for PTSD patients who live in unsafe conditions could substantially reduce suffering of individuals and their families in Brazil. Based on this result, the extent to which such interventions may be useful as a first step in tackling the consequences of violence on a global scale will be discussed. TRIAL REGISTRATION Deutsches Register Klinischer Studien (German Clinical Trials Register) DRKS00017843 . Registered on September 24, 2019.",2021,"DISCUSSION Effective treatment for PTSD patients who live in unsafe conditions could substantially reduce suffering of individuals and their families in Brazil.","['PTSD patients living under these conditions', 'Individuals fulfilling the criteria for PTSD and who live in conditions of ongoing community violence (i.e. in the favelas) in Rio de Janeiro', 'trauma survivors who live under ongoing threat of violence in Rio de Janeiro, Brazil', 'PTSD patients who live in unsafe conditions']","['Narrative Exposure Therapy (NET) or treatment as usual (TAU', 'Narrative Exposure Therapy']","['posttraumatic stress disorder (PTSD), depression and other mental disorders']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0445581', 'cui_str': 'Rio'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]",,0.0605352,"DISCUSSION Effective treatment for PTSD patients who live in unsafe conditions could substantially reduce suffering of individuals and their families in Brazil.","[{'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Serpeloni', 'Affiliation': 'Department of Studies on Violence and Health Jorge Careli, National School of Public Health, Oswaldo Cruz Foundation, Avenida Brasil 4036, 700 Manguinhos, Rio de Janeiro, 21040-361, Brazil.'}, {'ForeName': 'Jeanine Arabella', 'Initials': 'JA', 'LastName': 'Narrog', 'Affiliation': 'Vivo International e.V., Postbox 5108, 78430, Konstanz, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Gonçalves de Assis', 'Affiliation': 'Department of Studies on Violence and Health Jorge Careli, National School of Public Health, Oswaldo Cruz Foundation, Avenida Brasil 4036, 700 Manguinhos, Rio de Janeiro, 21040-361, Brazil.'}, {'ForeName': 'Joviana', 'Initials': 'J', 'LastName': 'Quintes Avanci', 'Affiliation': 'Department of Studies on Violence and Health Jorge Careli, National School of Public Health, Oswaldo Cruz Foundation, Avenida Brasil 4036, 700 Manguinhos, Rio de Janeiro, 21040-361, Brazil.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Carleial', 'Affiliation': 'Department of Psychology, University of Konstanz, Universitätsstraße 10, Konstanz, 78464, Germany.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Koebach', 'Affiliation': 'Vivo International e.V., Postbox 5108, 78430, Konstanz, Germany. anke.koebach@uni-konstanz.de.'}]",Trials,['10.1186/s13063-021-05082-2'] 2318,33647676,"Effect of guided imagery on anxiety, muscle pain, and vital signs in patients with COVID-19: A randomized controlled trial.","BACKGROUND COVID-19 can lead to anxiety due to its high mortality rate. Patients with COVID-19 may suffer from muscle pain. This study aimed to determine the effect of guided imagery on anxiety, muscle pain, and vital signs in patients with COVID-19. METHODS 110 patients with COVID-19 were recruited and randomly assigned to two control and intervention groups. Data were collected using the Spielberger Anxiety Inventory, the McGill Pain Questionnaire, and the Visual Analogue Scale. The intervention group received ten training sessions of guided imagery. RESULTS The results indicated a significant difference in the mean scores of state (t = -3.829, p < .001), trait anxiety (t = -2.946, p = .004), pain quality (t = -4.223, p < .001), pain intensity (t = -3.068, p = .003), and heart rate, systolic blood pressure, and oxygen saturation (p < .001) between the two groups after the intervention. CONCLUSIONS Guided imagery as a cost-effective method of complementary medicine is recommended to manage anxiety and pain in patients with COVID-19.",2021,"Data were collected using the Spielberger Anxiety Inventory, the McGill Pain Questionnaire, and the Visual Analogue Scale.","['110 patients with COVID-19', 'patients with COVID-19', 'Patients with COVID-19 may suffer from muscle pain']","['guided imagery', 'training sessions of guided imagery']","['trait anxiety', 'Spielberger Anxiety Inventory, the McGill Pain Questionnaire, and the Visual Analogue Scale', 'pain intensity', 'anxiety, muscle pain, and vital signs', 'mean scores of state', 'pain quality', 'heart rate, systolic blood pressure, and oxygen saturation']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}]",110.0,0.109641,"Data were collected using the Spielberger Anxiety Inventory, the McGill Pain Questionnaire, and the Visual Analogue Scale.","[{'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Parizad', 'Affiliation': 'Patient Safety Research Center, Clinical Research Institute, Nursing & Midwifery School, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Rasoul', 'Initials': 'R', 'LastName': 'Goli', 'Affiliation': 'Department of Medical-surgical Nursing, School of Nursing and Midwifery, Urmia University of Medical Sciences, Urmia, Iran. Electronic address: rasoulgoli94@gmail.com.'}, {'ForeName': 'Navid', 'Initials': 'N', 'LastName': 'Faraji', 'Affiliation': 'Department of Medical-surgical Nursing, School of Nursing and Midwifery, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Mam-Qaderi', 'Affiliation': 'Department of Medical-surgical Nursing, School of Nursing and Midwifery, Islamic Azad University, Urmia Branch, Urmia, Iran.'}, {'ForeName': 'Roshanak', 'Initials': 'R', 'LastName': 'Mirzaee', 'Affiliation': 'Department of Psychiatric Nursing, School of Nursing and Midwifery, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Gharebaghi', 'Affiliation': 'Department of Infectious Diseases, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Rahim', 'Initials': 'R', 'LastName': 'Baghaie', 'Affiliation': 'Patient Safety Research Center, Clinical Research Institute, Nursing & Midwifery School, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Haedeh', 'Initials': 'H', 'LastName': 'Feizipour', 'Affiliation': 'Department of Medical Sicences, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Mah-Monir', 'Initials': 'MM', 'LastName': 'Haghighi', 'Affiliation': 'Department of Medical Sicences, Urmia University of Medical Sciences, Urmia, Iran.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101335'] 2319,33640458,"Effects of applying external cold and vibration to children during vaccination on pain, fear and anxiety.","OBJECTIVES This study aimed to evaluate the effectiveness of the application of external cold and vibration on children experiencing pain, fear and anxiety during vaccination. DESIGN AND SETTING This randomized controlled, experimental study was conducted in primary schools selected within the scope of school immunization days by a community health center. The study population consisted of first grade students who were scheduled to receive a booster dose of diphtheria, tetanus, and acellular pertussis, inactivated poliovirus vaccine (DTaP-IPV) vaccine within the scope of the school immunization program of the said community health center and the study sample consisted of 90 students (experimental: 45, control:45). MAIN OUTCOME MEASURES In the experimental group, a device that applies external cold and vibration (Buzzy®) was placed on the injection site for 30 s before administration of the vaccine. The device was then placed above the injection site and kept there during the injection. No intervention was made during the injections in children included in the control group. The same nurse administered the injections in the experimental and control groups. RESULTS In the current study, it was found that there was a statistically significant difference between the experimental group and the control group in terms of the children's pain, the nurse's pain, the nurse's fear and the children's anxiety (p < 0.05), but no statistically significant difference in terms of the children's fear (p > 0.05). CONCLUSIONS It was concluded that applying external cold and vibration during vaccination has an effect on the level of children's pain and anxiety.",2021,"This study aimed to evaluate the effectiveness of the application of external cold and vibration on children experiencing pain, fear and anxiety during vaccination. ","['said community health center and the study sample consisted of 90 students (experimental: 45, control:45', 'primary schools selected within the scope of school immunization days by a community health center', 'children experiencing pain, fear and anxiety during vaccination']","['device that applies external cold and vibration (Buzzy®', 'diphtheria, tetanus, and acellular pertussis, inactivated poliovirus vaccine (DTaP-IPV) vaccine', 'external cold and vibration']","['pain, fear and anxiety', ""children's pain, the nurse's pain, the nurse's fear and the children's anxiety"", ""children's fear""]","[{'cui': 'C0080151', 'cui_str': 'Simian AIDS'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0012546', 'cui_str': 'Diphtheria'}, {'cui': 'C0039614', 'cui_str': 'Tetanus'}, {'cui': 'C0982332', 'cui_str': 'acellular pertussis vaccine, inactivated'}, {'cui': 'C0036106', 'cui_str': 'Salk Vaccine'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]",90.0,0.0269343,"This study aimed to evaluate the effectiveness of the application of external cold and vibration on children experiencing pain, fear and anxiety during vaccination. ","[{'ForeName': 'Eda', 'Initials': 'E', 'LastName': 'Sapçi', 'Affiliation': 'Gaziantep 25 Aralık State Hospital, Turkey.'}, {'ForeName': 'Elif', 'Initials': 'E', 'LastName': 'Bilsin Kocamaz', 'Affiliation': 'Gaziantep University, Faculty of Health Sciences, Department of Nursing, Turkey. Electronic address: elifbilsin-86@hotmail.com.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Gungormus', 'Affiliation': 'Gaziantep University, Faculty of Health Sciences, Department of Nursing, Turkey.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2021.102688'] 2320,33646146,Low Doses of Ionizing Radiation as a Treatment for Alzheimer's Disease: A Pilot Study.,"BACKGROUND In 2015, a patient in hospice with Alzheimer's disease (AD) was treated with ionizing radiation to her brain using repeated CT scans. Improvement in cognition, speech, movement, and appetite was observed. These improvements were so momentous that she was discharged from the hospice to a long-term care home. Based on this case, we conducted a pilot clinical trial to examine the effect of low-dose ionizing radiation (LDIR) in severe AD. OBJECTIVE To determine whether the previously reported benefits of LDIR in a single case with AD could be observed again in other cases with AD when the same treatments are given. METHODS In this single-arm study, four patients were treated with three consecutive treatments of LDIR, each spaced two weeks apart. Qualitative changes in communication and behavior with close relatives were observed and recorded. Quantitative measures of cognition and behavior were administered pre and post LDIR treatments. RESULTS Minor improvements on quantitative measures were noted in three of the four patients following treatment. However, the qualitative observations of cognition and behavior suggested remarkable improvements within days post-treatment, including greater overall alertness. One patient showed no change. CONCLUSION LDIR may be a promising, albeit controversial therapy for AD. Trials of patients with less severe AD, double-blind and placebo-controlled, should be carried out to determine the benefits of LDIR. Quantitative measures are needed that are sensitive to the remarkable changes induced by LDIR, such as biological markers of oxidative stress that are associated with AD.",2021,"However, the qualitative observations of cognition and behavior suggested remarkable improvements within days post-treatment, including greater overall alertness.","['patients with less severe AD', ""Alzheimer's Disease"", ""In 2015, a patient in hospice with Alzheimer's disease (AD"", 'severe AD']","['placebo', 'Ionizing Radiation', 'low-dose ionizing radiation (LDIR', 'ionizing radiation to her brain using repeated CT scans']","['cognition, speech, movement, and appetite', 'overall alertness', 'quantitative measures']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0019947', 'cui_str': 'Hospice'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034538', 'cui_str': 'Ionizing radiation'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",4.0,0.161687,"However, the qualitative observations of cognition and behavior suggested remarkable improvements within days post-treatment, including greater overall alertness.","[{'ForeName': 'Jerry M', 'Initials': 'JM', 'LastName': 'Cuttler', 'Affiliation': 'Cuttler & Associates, Vaughan, ON, Canada.'}, {'ForeName': 'Eslam', 'Initials': 'E', 'LastName': 'Abdellah', 'Affiliation': 'Baycrest Health Sciences, Toronto, ON, Canada.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Goldberg', 'Affiliation': 'Baycrest Health Sciences, Toronto, ON, Canada.'}, {'ForeName': 'Sarmad', 'Initials': 'S', 'LastName': 'Al-Shamaa', 'Affiliation': 'Baycrest Health Sciences, Toronto, ON, Canada.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Symons', 'Affiliation': 'Departments of Medical Imaging and Otolaryngology-Head and Neck Surgery, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Black', 'Affiliation': 'Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute, Toronto, ON, Canada.'}, {'ForeName': 'Morris', 'Initials': 'M', 'LastName': 'Freedman', 'Affiliation': 'Baycrest Health Sciences, Toronto, ON, Canada.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200620'] 2321,33648350,Efficacy and safety of modafinil versus dexamethasone in cancer-related fatigue: a prospective randomized controlled study.,"The aim of this study was to compare the efficacy and safety of modafinil and dexamethasone in the management of cancer-related fatigue and their effects on quality of life (QoL). A prospective randomized controlled study was conducted, enrolling 80 cancer patients experiencing moderate or severe fatigue following at least three cycles of chemotherapy or a course of palliative/curative radiotherapy. Patients received either oral modafinil 100 mg or dexamethasone 4 mg daily for 14 days. Levels of fatigue, QoL and symptom severity were compared after 14-21 days. Both drugs were efficacious and safe in the management of fatigue and QoL. However, modafinil performed marginally better. Although modafinil demonstrated marginal superiority, both modafinil and dexamethasone can improve fatigue and QoL in cancer patients. Clinical trials registry of India: CTRI/2018/05/014046 (www.ctri.nic.in).",2021,"Although modafinil demonstrated marginal superiority, both modafinil and dexamethasone can improve fatigue and QoL in cancer patients.","['cancer patients', 'enrolling 80 cancer patients experiencing moderate or severe fatigue following at least three cycles of chemotherapy or a course of palliative/curative radiotherapy', 'cancer-related fatigue']","['modafinil and dexamethasone', 'oral modafinil 100\xa0mg or dexamethasone', 'modafinil', 'modafinil versus dexamethasone']","['fatigue and QoL', 'Efficacy and safety', 'efficacy and safety', 'Levels of fatigue, QoL and symptom severity', 'quality of life (QoL']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}]","[{'cui': 'C0066677', 'cui_str': 'modafinil'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0987899', 'cui_str': 'modafinil 100 MG'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2586108', 'cui_str': 'Level of fatigue'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}]",80.0,0.0904192,"Although modafinil demonstrated marginal superiority, both modafinil and dexamethasone can improve fatigue and QoL in cancer patients.","[{'ForeName': 'Uttiya', 'Initials': 'U', 'LastName': 'Deb', 'Affiliation': 'Pharmacology, Burdwan Medical College, Burdwan, 713104, India.'}, {'ForeName': 'Sandip', 'Initials': 'S', 'LastName': 'Mukhopadhyay', 'Affiliation': 'Pharmacology, Burdwan Medical College, Burdwan, 713104, India.'}, {'ForeName': 'Biswamit', 'Initials': 'B', 'LastName': 'Bhattacharya', 'Affiliation': 'Radiation Oncology, Burdwan Medical College, Burdwan,\xa0713104, India.'}, {'ForeName': 'Sanatan', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Radiation Oncology, Burdwan Medical College, Burdwan,\xa0713104, India.'}, {'ForeName': 'Supreeti', 'Initials': 'S', 'LastName': 'Biswas', 'Affiliation': 'Pharmacology, Burdwan Medical College, Burdwan, 713104, India.'}]","Future oncology (London, England)",['10.2217/fon-2020-0853'] 2322,33647384,Physiological responses to acute psychosocial stress in women with menopausal insomnia.,"INTRODUCTION Insomnia disorder is a common sleep disorder and frequently emerges in the context of menopause, being associated with menopause-specific factors such as hot flashes and other psychosocial variables. Increased vulnerability to stress may also contribute to the development of insomnia in midlife women. Here, we aimed to investigate whether there are differences in physiological reactivity to acute psychosocial stress in women with menopausal insomnia compared with controls. METHODS We investigated cortisol and heart rate [HR] responses to an acute experimental psychosocial stress (Trier Social Stress Test, TSST) approximately 1 h after waking in the morning in midlife women with (n = 22) and without (n = 16) DSM-IV insomnia disorder (Age: 50.05 ± 3.10 years), developed in the context of menopause. RESULTS Despite similar perceived stress levels, women with insomnia showed blunted HR increases (~29% HR acceleration) to the TSST compared to controls (~44% HR acceleration) (p = 0.026). No group differences in HR were detected at baseline or during post-task recovery. Cortisol stress responses were inconclusive, with most of the women (60%) failing to exhibit significant cortisol increases in response to the TSST. A greater magnitude of the cortisol awakening response (CAR) predicted the likelihood of being a non-responder (p = 0.036), showing the confounding effect of CAR on cortisol stress responses. DISCUSSION Women with menopausal insomnia show blunted cardiac responses to stress, suggesting alterations in the autonomic reactivity to acute stress. Whether these alterations are pre-existing or are a consequence of insomnia, needs to be determined.",2021,"Despite similar perceived stress levels, women with insomnia showed blunted HR increases (~29% HR acceleration) to the TSST compared to controls (~44% HR acceleration) (p = 0.026).","['midlife women with (n\u202f=\u202f22) and without (n\u202f=\u202f16) DSM-IV insomnia disorder (Age: 50.05\u202f±\u202f3.10\u202fyears), developed in the context of menopause', 'women with menopausal insomnia compared with controls', 'women with menopausal insomnia', 'midlife women']","['acute experimental psychosocial stress (Trier Social Stress Test, TSST', 'TSST']","['HR', 'blunted HR increases', 'Cortisol stress responses', 'cortisol and heart rate [HR] responses', 'cortisol awakening response (CAR']","[{'cui': 'C0026062', 'cui_str': 'Middle-age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0341866', 'cui_str': 'Menopausal sleeplessness'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1997754', 'cui_str': 'Heart rate response'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}]",,0.0827947,"Despite similar perceived stress levels, women with insomnia showed blunted HR increases (~29% HR acceleration) to the TSST compared to controls (~44% HR acceleration) (p = 0.026).","[{'ForeName': 'Dilara', 'Initials': 'D', 'LastName': 'Yuksel', 'Affiliation': 'Center for Health Sciences, SRI International, Menlo Park, CA 94025, USA.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'de Zambotti', 'Affiliation': 'Center for Health Sciences, SRI International, Menlo Park, CA 94025, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sugarbaker', 'Affiliation': 'Center for Health Sciences, SRI International, Menlo Park, CA 94025, USA.'}, {'ForeName': 'Tilman', 'Initials': 'T', 'LastName': 'Schulte', 'Affiliation': 'Center for Health Sciences, SRI International, Menlo Park, CA 94025, USA; Department of Psychology, Palo Alto University, 1791 Arastradero Rd, Palo Alto, CA 94304, USA.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Colrain', 'Affiliation': 'Center for Health Sciences, SRI International, Menlo Park, CA 94025, USA; Melbourne School of Psychological Sciences, The University of Melbourne, Parkville, VIC 3010, Australia.'}, {'ForeName': 'Fiona C', 'Initials': 'FC', 'LastName': 'Baker', 'Affiliation': 'Center for Health Sciences, SRI International, Menlo Park, CA 94025, USA; Brain Function Research Group, School of Physiology, University of the Witwatersrand, Johannesburg 2000, South Africa. Electronic address: fiona.baker@sri.com.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2021.02.019'] 2323,33647373,A randomised controlled trial to compare the efficacy of an aluminium lactate/potassium nitrate/hydroxylapatite toothpaste with a control toothpaste for the prevention of dentine hypersensitivity.,"OBJECTIVES To determine the efficacy of a cosmetic aluminium lactate/potassium nitrate/hydroxylapatite toothpaste for the reduction of dentine hypersensitivity (DH) pain as compared to a control toothpaste containing potassium nitrate. METHODS The study was a randomised, examiner-blind, two treatment arm, parallel controlled trial in healthy adults with at least 2 sensitive teeth (Schiff >2). At baseline, immediately after treatment and at 7 and 14 days of twice-daily brushing of the test or control toothpaste the sensitivity of 2 test teeth was measured following iced-water (Schiff and VAS) and tactile (Yeaple probe) stimuli, and a whole mouth plaque score was obtained. Participants also completed a whole-mouth VAS and DHEQ15 quality of life questionnaire at baseline, 7 and 14 days. RESULTS Both toothpastes reduced DH in test teeth, but pain reduction in the test group was significantly better at all timepoints and by all measures (p = 0.005, tooth-level VAS immediately after brushing; p < 0.001 all other comparisons). There was a relative risk reduction of Schiff sensitivity of 55 % immediately after brushing which rose to 81 % after 7 and 88.6 % after 14 days (all p < 0.001). There were no differences in plaque, whole mouth VAS or DHEQ15 scores at any time point. CONCLUSION This study demonstrated the efficacy of an aluminium lactate/potassium nitrate/hydroxylapatite toothpaste compared to a potassium nitrate control toothpaste for the prevention of dentine hypersensitivity both immediately and over a 2 week period. This agent appears to have potential for pain alleviation from the common oral pain condition of DH and further research is warranted. CLINICAL SIGNIFICANCE DH pain, whilst transient in nature, is arresting in magnitude, affecting quality of life. Daily application of efficacious toothpastes can relieve DH pain however, as yet, there is no gold standard treatment. The results of this study support further investigation of an aluminium lactate/potassium nitrate/hydroxylapatite toothpaste for DH management.",2021,"Both toothpastes reduced DH in test teeth, but pain reduction in the test group was significantly better at all timepoints and by all measures (p = 0.005, tooth-level VAS immediately after brushing; p < 0.001 all other comparisons).",['healthy adults with at least 2 sensitive teeth (Schiff >2'],"['aluminium lactate/potassium nitrate/hydroxylapatite toothpaste', 'aluminium lactate/potassium nitrate/hydroxylapatite toothpaste with a control toothpaste', 'potassium nitrate control toothpaste', 'cosmetic aluminium lactate/potassium nitrate/hydroxylapatite toothpaste']","['whole-mouth VAS and DHEQ15 quality of life questionnaire', 'dentine hypersensitivity (DH) pain', 'pain reduction', 'dentine hypersensitivity', 'DH pain', 'plaque, whole mouth VAS or DHEQ15 scores', 'relative risk reduction of Schiff sensitivity']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C2949227', 'cui_str': 'Schiff'}]","[{'cui': 'C0002367', 'cui_str': 'Aluminum'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0071772', 'cui_str': 'potassium nitrate'}, {'cui': 'C0115137', 'cui_str': 'Durapatite'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C2949227', 'cui_str': 'Schiff'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.0387411,"Both toothpastes reduced DH in test teeth, but pain reduction in the test group was significantly better at all timepoints and by all measures (p = 0.005, tooth-level VAS immediately after brushing; p < 0.001 all other comparisons).","[{'ForeName': 'Joon', 'Initials': 'J', 'LastName': 'Seong', 'Affiliation': 'Clinical Trials Group, School of Oral and Dental Sciences, University of Bristol, Lower Maudlin Street, Bristol, BS1 2LY, UK. Electronic address: J.Seong@bristol.ac.uk.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Newcombe', 'Affiliation': 'Cardiff University, Cardiff, CF10 3AT, UK. Electronic address: newcombe@cardiff.ac.uk.'}, {'ForeName': 'Helen L', 'Initials': 'HL', 'LastName': 'Foskett', 'Affiliation': 'Clinical Trials Group, School of Oral and Dental Sciences, University of Bristol, Lower Maudlin Street, Bristol, BS1 2LY, UK. Electronic address: Helen.foskett@bristol.ac.uk.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Davies', 'Affiliation': 'Clinical Trials Group, School of Oral and Dental Sciences, University of Bristol, Lower Maudlin Street, Bristol, BS1 2LY, UK. Electronic address: maria.davies@bristol.ac.uk.'}, {'ForeName': 'Nicola X', 'Initials': 'NX', 'LastName': 'West', 'Affiliation': 'Clinical Trials Group, School of Oral and Dental Sciences, University of Bristol, Lower Maudlin Street, Bristol, BS1 2LY, UK. Electronic address: n.x.west@bristol.ac.uk.'}]",Journal of dentistry,['10.1016/j.jdent.2021.103619'] 2324,33652807,A Pilot Study Comparing the Effects of Consuming 100% Orange Juice or Sucrose-Sweetened Beverage on Risk Factors for Cardiometabolic Disease in Women.,"Overconsumption of sugar-sweetened beverages increases risk factors associated with cardiometabolic disease, in part due to hepatic fructose overload. However, it is not clear whether consumption of beverages containing fructose as naturally occurring sugar produces equivalent metabolic dysregulation as beverages containing added sugars. We compared the effects of consuming naturally-sweetened orange juice (OJ) or sucrose-sweetened beverages (sucrose-SB) for two weeks on risk factors for cardiometabolic disease. Healthy, overweight women ( n = 20) were assigned to consume either 3 servings of 100% orange juice or sucrose-SB/day. We conducted 16-hour serial blood collections and 3-h oral glucose tolerance tests during a 30-h inpatient visit at baseline and after the 2-week diet intervention. The 16-h area under the curve (AUC) for uric acid increased in subjects consuming sucrose-SB compared with subjects consuming OJ. Unlike sucrose-SB, OJ did not significantly increase fasting or postprandial lipoproteins. Consumption of both beverages resulted in reductions in the Matsuda insulin sensitivity index (OJ: -0.40 ± 0.18, p = 0.04 within group; sucrose-SB: -1.0 ± 0.38, p = 0.006 within group; p = 0.53 between groups). Findings from this pilot study suggest that consumption of OJ at levels above the current dietary guidelines for sugar intake does not increase plasma uric acid concentrations compared with sucrose-SB, but appears to lead to comparable decreases of insulin sensitivity.",2021,The 16-h area under the curve (AUC) for uric acid increased in subjects consuming sucrose-SB compared with subjects consuming OJ.,"['Healthy, overweight women ( n = 20', 'Cardiometabolic Disease in Women']","['consume either 3 servings of 100% orange juice or sucrose-SB/day', 'consuming naturally-sweetened orange juice (OJ) or sucrose-sweetened beverages (sucrose-SB', 'Consuming 100% Orange Juice or Sucrose-Sweetened Beverage']","['fasting or postprandial lipoproteins', '16-h area under the curve (AUC) for uric acid', 'insulin sensitivity', 'plasma uric acid concentrations', 'Matsuda insulin sensitivity index']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0857451', 'cui_str': 'Plasma uric acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",20.0,0.0411295,The 16-h area under the curve (AUC) for uric acid increased in subjects consuming sucrose-SB compared with subjects consuming OJ.,"[{'ForeName': 'Candice Allister', 'Initials': 'CA', 'LastName': 'Price', 'Affiliation': 'Department of Molecular Biosciences, School of Veterinary Medicine, University of California Davis, Davis, CA 95616, USA.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Medici', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine (V.M.), University of California Davis, Sacramento, CA 95817, USA.'}, {'ForeName': 'Marinelle V', 'Initials': 'MV', 'LastName': 'Nunez', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, CA 95616, USA.'}, {'ForeName': 'Vivien', 'Initials': 'V', 'LastName': 'Lee', 'Affiliation': 'Department of Molecular Biosciences, School of Veterinary Medicine, University of California Davis, Davis, CA 95616, USA.'}, {'ForeName': 'Desiree M', 'Initials': 'DM', 'LastName': 'Sigala', 'Affiliation': 'Department of Molecular Biosciences, School of Veterinary Medicine, University of California Davis, Davis, CA 95616, USA.'}, {'ForeName': 'Yanet', 'Initials': 'Y', 'LastName': 'Benyam', 'Affiliation': 'Department of Molecular Biosciences, School of Veterinary Medicine, University of California Davis, Davis, CA 95616, USA.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Keim', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, CA 95616, USA.'}, {'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Mason', 'Affiliation': 'Osher Center for Integrative Medicine, School of Medicine, University of California San Francisco, San Francisco, CA 94155, USA.'}, {'ForeName': 'Shin-Yu', 'Initials': 'SY', 'LastName': 'Chen', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, CA 95616, USA.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Parenti', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, CA 95616, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Slupsky', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, CA 95616, USA.'}, {'ForeName': 'Elissa S', 'Initials': 'ES', 'LastName': 'Epel', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA 94143, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Havel', 'Affiliation': 'Department of Molecular Biosciences, School of Veterinary Medicine, University of California Davis, Davis, CA 95616, USA.'}, {'ForeName': 'Kimber L', 'Initials': 'KL', 'LastName': 'Stanhope', 'Affiliation': 'Department of Molecular Biosciences, School of Veterinary Medicine, University of California Davis, Davis, CA 95616, USA.'}]",Nutrients,['10.3390/nu13030760'] 2325,33652763,The Effectiveness and Safety of Multi-Strain Probiotic Preparation in Patients with Diarrhea-Predominant Irritable Bowel Syndrome: A Randomized Controlled Study.,"The aim of this randomized double-blind placebo-controlled study was to evaluate the effectiveness and safety of multi-strain probiotic in adults with diarrhea-predominant irritable bowel syndrome (IBS-D). The patients were randomized to receive a mixture of Lactobacillus , Bifidobacterium , and Streptococcus thermophilus strains or placebo for eight weeks. Primary endpoints included changes in symptom severity and improvement assessed with the IBS Severity Scoring System (IBS-SSS) and Global Improvement Scale (IBS-GIS). The probiotic in comparison with placebo significantly improved the IBS symptom severity (the change of total IBS-SSS score from baseline ‒165.8 ± 78.9 in the probiotic group and ‒105.6 ± 60.2 in the placebo group, p = 0.005) and in the specific scores related to the severity of pain ( p = 0.015) and the quality of life ( p = 0.016) after eight weeks of intervention. The probiotic group indicated an improvement in symptoms with the use of the IBS-GIS compared with the placebo group after four ( p = 0.04) and eight weeks ( p = 0.003). The occurrence of adverse events did not differ between study groups. In conclusion, the multi-strain probiotic intervention resulted in a significant improvement in IBS symptoms evaluated with the use of both IBS-SSS and IBS-GIS scales. The results suggest that the studied probiotic preparation is well tolerated and safe and can offer benefits for patients with IBS-D. (registration number in Clinicaltrials.gov NCT04662957).",2021,The probiotic group indicated an improvement in symptoms with the use of the IBS-GIS compared with the placebo group after four ( p = 0.04) and eight weeks ( p = 0.003).,"['Patients with Diarrhea-Predominant Irritable Bowel Syndrome', 'adults with diarrhea-predominant irritable bowel syndrome (IBS-D']","['multi-strain probiotic intervention', 'placebo', 'multi-strain probiotic', 'Multi-Strain Probiotic Preparation', 'mixture of Lactobacillus , Bifidobacterium , and Streptococcus thermophilus strains or placebo']","['occurrence of adverse events', 'total IBS-SSS score', 'IBS symptoms', 'IBS symptom severity', 'IBS-GIS', 'severity of pain', 'changes in symptom severity and improvement assessed with the IBS Severity Scoring System (IBS-SSS) and Global Improvement Scale (IBS-GIS', 'effectiveness and safety', 'tolerated and safe', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1262211', 'cui_str': 'Diarrhoea predominant irritable bowel syndrome'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0318180', 'cui_str': 'Streptococcus salivarius subsp. thermophilus'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0037052', 'cui_str': 'Sick sinus syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0815319', 'cui_str': 'Geographical Information Systems'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.21493,The probiotic group indicated an improvement in symptoms with the use of the IBS-GIS compared with the placebo group after four ( p = 0.04) and eight weeks ( p = 0.003).,"[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Skrzydło-Radomańska', 'Affiliation': 'Department of Gastroenterology, Medical University of Lublin, Jaczewskiego 8, 20-950 Lublin, Poland.'}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Prozorow-Król', 'Affiliation': 'Department of Gastroenterology, Medical University of Lublin, Jaczewskiego 8, 20-950 Lublin, Poland.'}, {'ForeName': 'Halina', 'Initials': 'H', 'LastName': 'Cichoż-Lach', 'Affiliation': 'Department of Gastroenterology, Medical University of Lublin, Jaczewskiego 8, 20-950 Lublin, Poland.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Majsiak', 'Affiliation': 'Faculty of Medicine, Cardinal Stefan Wyszynski University, Wóycickiego 1/3, 01-938 Warsaw, Poland.'}, {'ForeName': 'Joanna Beata', 'Initials': 'JB', 'LastName': 'Bierła', 'Affiliation': 'Department of Pathomorphology, The Children Memorial Health Institute, Aleja Dzieci Polskich 20, 04-730 Warsaw, Poland.'}, {'ForeName': 'Ewelina', 'Initials': 'E', 'LastName': 'Kanarek', 'Affiliation': 'Department of Pathomorphology, The Children Memorial Health Institute, Aleja Dzieci Polskich 20, 04-730 Warsaw, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Sowińska', 'Affiliation': 'Department of Pathomorphology, The Children Memorial Health Institute, Aleja Dzieci Polskich 20, 04-730 Warsaw, Poland.'}, {'ForeName': 'Bożena', 'Initials': 'B', 'LastName': 'Cukrowska', 'Affiliation': 'Department of Pathomorphology, The Children Memorial Health Institute, Aleja Dzieci Polskich 20, 04-730 Warsaw, Poland.'}]",Nutrients,['10.3390/nu13030756'] 2326,33652705,Effect of a Low-Glycemic Load Diet Intervention on Maternal and Pregnancy Outcomes in Obese Pregnant Women.,"The increased prevalence of obese, pregnant women who have a higher risk of glucose intolerance warrants the need for nutritional interventions to improve maternal glucose homeostasis. In this study, the effect of a low-glycemic load (GL) ( n = 28) was compared to a high-GL ( n = 34) dietary intervention during the second half of pregnancy in obese women (body mass index (BMI) > 30 or a body fat >35%). Anthropometric and metabolic parameters were assessed at baseline (20 week) and at 28 and 34 weeks gestation. For the primary outcome 3h-glucose-iAUC (3h-incremental area under the curve), mean between-group differences were non-significant at every study timepoint ( p = 0.6, 0.3, and 0.8 at 20, 28, and 34 weeks, respectively) and also assessing the mean change over the study period ( p = 0.6). Furthermore, there was no statistically significant difference between the two intervention groups for any of the other examined outcomes ( p ≥ 0.07). In the pooled cohort, there was no significant effect of dietary GL on any metabolic or anthropometric outcome ( p ≥ 0.2). A post hoc analysis comparing the study women to a cohort of overweight or obese pregnant women who received only routine care showed that the non-study women were more likely to gain excess weight ( p = 0.046) and to deliver large-for-gestational-age (LGA) ( p = 0.01) or macrosomic ( p = 0.006) infants. Thus, a low-GL diet consumed during the last half of pregnancy did not improve pregnancy outcomes in obese women, but in comparison to non-study women, dietary counseling reduced the risk of adverse outcomes.",2021,"Furthermore, there was no statistically significant difference between the two intervention groups for any of the other examined outcomes ( p ≥ 0.07).","['Obese Pregnant Women', 'obese women', 'study women to a cohort of overweight or obese pregnant women who received only routine care showed that the non-study women']","['high-GL ( n = 34) dietary intervention', 'Low-Glycemic Load Diet Intervention', 'low-glycemic load (GL']","['glucose-iAUC', 'gain excess weight', 'metabolic or anthropometric outcome', 'Maternal and Pregnancy Outcomes', 'Anthropometric and metabolic parameters', 'pregnancy outcomes']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4042927', 'cui_str': 'Glycemic Load'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0262232,"Furthermore, there was no statistically significant difference between the two intervention groups for any of the other examined outcomes ( p ≥ 0.07).","[{'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Goletzke', 'Affiliation': 'Department of Nutritional Sciences and Toxicology, University of California, Berkeley, CA 94720, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'De Haene', 'Affiliation': 'Independent Nutrition Consultant, Dallas, TX 75035, USA.'}, {'ForeName': 'Naomi E', 'Initials': 'NE', 'LastName': 'Stotland', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California San Francisco, San Francisco, CA 94110, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Murphy', 'Affiliation': 'Department of Medicine, Division of Endocrinology and Metabolism, San Francisco General Hospital, University of California, San Francisco, San Francisco, CA 94110, USA.'}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Perez-Rodriguez', 'Affiliation': 'Research Coordinator, Mexican Institute of Social Security (IMSS), Mexico City 06720, Mexico.'}, {'ForeName': 'Janet C', 'Initials': 'JC', 'LastName': 'King', 'Affiliation': 'Department of Nutritional Sciences and Toxicology, University of California, Berkeley, CA 94720, USA.'}]",Nutrients,['10.3390/nu13030748'] 2327,33656578,Anodal tDCS modulates specific processing codes during conflict monitoring associated with superior and middle frontal cortices.,"Conflict monitoring processes are central for cognitive control. Neurophysiological correlates of conflict monitoring (i.e. the N2 ERP) likely represent a mixture of different cognitive processes. Based on theoretical considerations, we hypothesized that effects of anodal tDCS (atDCS) in superior frontal areas affect specific subprocesses in neurophysiological activity during conflict monitoring. To investigate this, young healthy adults performed a Simon task while EEG was recorded. atDCS and sham tDCS were applied in a single-blind, cross-over study design. Using temporal signal decomposition in combination with source localization analyses, we demonstrated that atDCS effects on cognitive control are very specific: the detrimental effect of atDCS on response speed was largest in case of response conflicts. This however only showed in aspects of the decomposed N2 component, reflecting stimulus-response translation processes. In contrast to this, stimulus-related aspects of the N2 as well as purely response-related processes were not modulated by atDCS. EEG source localization analyses revealed that the effect was likely driven by activity modulations in the superior frontal areas, including the supplementary motor cortex (BA6), as well as middle frontal (BA9) and medial frontal areas (BA32). atDCS did not modulate effects of proprioceptive information on hand position, even though this aspect is known to be processed within the same brain areas. Physiological effects of atDCS likely modulate specific aspects of information processing during cognitive control.",2021,"EEG source localization analyses revealed that the effect was likely driven by activity modulations in the superior frontal areas, including the supplementary motor cortex (BA6), as well as middle frontal (BA9) and medial frontal areas (BA32).",['young healthy adults'],"['atDCS and sham tDCS', 'Anodal tDCS', 'atDCS', 'anodal tDCS (atDCS']","['supplementary motor cortex (BA6), as well as middle frontal (BA9) and medial frontal areas (BA32']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C3496174', 'cui_str': 'Supplementary Motor Area'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",,0.0236817,"EEG source localization analyses revealed that the effect was likely driven by activity modulations in the superior frontal areas, including the supplementary motor cortex (BA6), as well as middle frontal (BA9) and medial frontal areas (BA32).","[{'ForeName': 'Nico', 'Initials': 'N', 'LastName': 'Adelhöfer', 'Affiliation': 'Cognitive Neurophysiology, Faculty of Medicine, Department of Child and Adolescent Psychiatry, TU Dresden, Fetscherstrasse 74, 01307, Dresden, Germany.'}, {'ForeName': 'Ann-Kathrin', 'Initials': 'AK', 'LastName': 'Stock', 'Affiliation': 'Cognitive Neurophysiology, Faculty of Medicine, Department of Child and Adolescent Psychiatry, TU Dresden, Fetscherstrasse 74, 01307, Dresden, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Beste', 'Affiliation': 'Cognitive Neurophysiology, Faculty of Medicine, Department of Child and Adolescent Psychiatry, TU Dresden, Fetscherstrasse 74, 01307, Dresden, Germany. christian.beste@uniklinikum-dresden.de.'}]",Brain structure & function,['10.1007/s00429-021-02245-4'] 2328,33638801,Safety and Efficacy of Perioperative Use of Evolocumab in Myocardial Infarction Patients: Study Protocol for a Multicentre Randomized Controlled Trial.,"INTRODUCTION The SECURE-PCI study supports a perioperative loading dose of statins, although whether an intensive lipid-lowering strategy prior to percutaneous coronary intervention further benefits acute coronary syndrome patients remains controversial. Evolocumab, a proprotein-converting enzyme subtilisin/kexin type 9 (PCSK9) inhibitor, acts more quickly and effectively than statins and reduces the risk of cardiovascular events in post-myocardial infarction (MI) patients. Nonetheless, whether it can be safely used in perioperative MI patients and whether perioperative application can benefit patients are still unknown. This study aims to evaluate the safety and efficacy of this treatment regimen. METHODS A multicentre, prospective, randomized, controlled superiority trial will be conducted in 530 statin-naïve MI patients. All eligible patients will be randomized to the evolocumab group (140 mg subcutaneously injected once before revascularization + 14 days after the first dose) or the control group (no evolocumab injection). Evolocumab will then be administered depending on the patient's lipid profile. Both groups will be treated simultaneously with standardized secondary preventive medications. The primary end points are major adverse cardiovascular events (a composite of death, recurrent MI, unanticipated revascularization, stroke and any rehospitalization for ischaemic causes) within 12 months. The secondary end point is post-infarction angina after pain relief. The safety end points include myopathy, impaired liver or renal function, and other adverse events during the follow-up period. OUTCOMES This is the first trial to evaluate the safety and efficacy of evolocumab pre-treatment on prognosis in MI patients. Perioperative evolocumab injection may be a new, safe way to improve prognosis. TRIAL REGISTRATION Chinese Clinical Trial Registry ( http://www.chictr.org.cn ; ChiCTR1900024526). Registered on 13 July 2019 and updated on 31 May 2020. The study is currently recruiting patients.",2021,"Evolocumab, a proprotein-converting enzyme subtilisin/kexin type 9 (PCSK9) inhibitor, acts more quickly and effectively than statins and reduces the risk of cardiovascular events in post-myocardial infarction (MI) patients.","['Myocardial Infarction Patients', '530 statin-naïve MI patients', 'MI patients']","['Evolocumab', 'evolocumab', 'control group (no evolocumab injection', 'Evolocumab, a proprotein-converting enzyme subtilisin/kexin type 9 (PCSK9) inhibitor', 'evolocumab pre-treatment']","['major adverse cardiovascular events (a composite of death, recurrent MI, unanticipated revascularization, stroke and any rehospitalization for ischaemic causes', 'post-infarction angina after pain relief', 'safety and efficacy', 'safety end points include myopathy, impaired liver or renal function, and other adverse events', 'Safety and Efficacy']","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}]","[{'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0038601', 'cui_str': 'Subtilisins'}, {'cui': 'C0165249', 'cui_str': 'Kexin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0423732', 'cui_str': 'After pains'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026848', 'cui_str': 'Disorder of muscle'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.122515,"Evolocumab, a proprotein-converting enzyme subtilisin/kexin type 9 (PCSK9) inhibitor, acts more quickly and effectively than statins and reduces the risk of cardiovascular events in post-myocardial infarction (MI) patients.","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Luan', 'Affiliation': ""Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, People's Republic of China. ryan1218@zju.edu.cn.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, People's Republic of China.""}, {'ForeName': 'Liding', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': ""Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, People's Republic of China.""}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': ""Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, People's Republic of China.""}, {'ForeName': 'Guosheng', 'Initials': 'G', 'LastName': 'Fu', 'Affiliation': ""Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, People's Republic of China. fugs@zju.edu.cn.""}, {'ForeName': 'Wenbin', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, People's Republic of China. 3313011@zju.edu.cn.""}]",Advances in therapy,['10.1007/s12325-021-01662-5'] 2329,33639518,Effects of progressive muscle relaxation training with music therapy on sleep and anger of patients at Community Mental Health Center.,"OBJECTIVE The objective is to examine the effects of progressive muscle relaxation training and music therapy applied to chronic psychiatric patients attending the Community Mental Health Center (CMHC) on their anger level and sleep quality. METHODS The sample of the study consisted of 66 chronic psychiatric patients (n = 32 in the control group; n = 34 in the intervention group). Progressive muscle relaxation training with music therapy were implemented in the intervention group as 2 sessions per week for 3 months. RESULTS A statistically significant difference was found between the pre-test and post-test mean scores of the intervention group (p ≤ .001). After the intervention, a statistically significant difference was found between the PSQI, anger-in, anger-out, anger-control, and trait anger scale scores of the two groups (p ≤ .001). CONCLUSION Relaxation training and music therapy are effective in controlling anger and increasing sleep quality in chronic psychiatric patients. CLINICAL TRIAL NUMBER NCT04620122.",2021,"After the intervention, a statistically significant difference was found between the PSQI, anger-in, anger-out, anger-control, and trait anger scale scores of the two groups (p ≤ .001). ","['chronic psychiatric patients attending the Community Mental Health Center (CMHC) on their anger level and sleep quality', 'chronic psychiatric patients', '66 chronic psychiatric patients (n\xa0=\xa032 in the control group; n\xa0=\xa034 in the intervention group', 'patients at Community Mental Health Center']","['progressive muscle relaxation training with music therapy', 'Relaxation training and music therapy', 'progressive muscle relaxation training and music therapy', 'Progressive muscle relaxation training with music therapy']","['sleep quality', 'PSQI, anger-in, anger-out, anger-control, and trait anger scale scores', 'sleep and anger']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0748064', 'cui_str': 'Psychiatric in-patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0009474', 'cui_str': 'CMHC'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]",66.0,0.0280356,"After the intervention, a statistically significant difference was found between the PSQI, anger-in, anger-out, anger-control, and trait anger scale scores of the two groups (p ≤ .001). ","[{'ForeName': 'Sema', 'Initials': 'S', 'LastName': 'İçel', 'Affiliation': 'Gaziantep Islamic Science and Technology University, Faculty of Health Sciences, Midwifery Department, Gaziantep, Turkey. Electronic address: icelsema@gmail.com.'}, {'ForeName': 'Ceyda', 'Initials': 'C', 'LastName': 'Başoğul', 'Affiliation': 'Adıyaman University, Faculty of Health Sciences, Department of Psychiatric Nursing, Adıyaman, Turkey. Electronic address: cbasogul@adiyaman.edu.tr.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101338'] 2330,33640444,Low-Dose Dexmedetomidine Reduces Median Effective Concentration (EC 50) of Propofol More than Fentanyl in Unparalysed Anaesthetised Patients for I-gel Insertion: a Randomised Controlled Trial.,"BACKGROUND Literature shows fentanyl reduces the median effective concentration (EC50) of propofol when used for various noxious stimuli. However, fentanyl combined with propofol has a depressive effect on haemodynamics. We hypothesise that low dose dexmedetomidine will reduce the propofol requirement for induction with better haemodynamic profile compared with fentanyl. MATERIAL AND METHODS 120 ASA I/II adult patients, of age group 20 to 60 years, scheduled for elective day-care surgeries under general anaesthesia were randomised to three equally distributed groups as group D, group F and group S (control) of 40 patients each. They received infusions of dexmedetomidine 0.5 mcg/kg, fentanyl 1.5 mcg/kg and normal saline (control) respectively over 5 min prior to induction with propofol TCI (Marsh model). EC50 of propofol (primary objective) for I-gel insertion in each group was determined from the estimated effect site concentration (Ce), using Dixon's up-and-down method . Secondary objectives were propofol dose requirement and percentage change in haemodynamics during induction. RESULTS Our study demonstrates that low-dose dexmedetomidine premedication achieves more reduction in the EC50 (2.4 µg/ml, IQR 2.4 - 2.6 µg/ml, 95% CI 2.40 - 2.55 µg/ml) and dose of propofol (1.14 ± 0.28 mg/kg, 95% CI 1.05 - 1.23 mg/kg), for I-gel insertion, than that can be achieved by the use of fentanyl with propofol (EC50 of 3.0 µg/ml IQR 3.0 - 3.05 µg/ml, 95% CI 2.94 - 3.11 µg/ml; propofol dose 1.89 ± 0.55 mg/kg, 95% CI 1.72 - 2.07 mg/kg ) without any significant change in the haemodynamics. CONCLUSION Low-dose dexmedetomidine when compared with fentanyl significantly reduce the EC50 and dose of propofol required for I-gel insertion with propofol TCI, without much change in the haemodynamic profile. CLINICAL TRIAL REGISTRATION NUMBER CTRI/2019/03/018003.",2021,"We hypothesise that low dose dexmedetomidine will reduce the propofol requirement for induction with better haemodynamic profile compared with fentanyl. ","['unparalysed anaesthetised patients for I-gel insertion', '120 ASA I/II adult patients of age group 20 to 60 years scheduled for elective day-care surgeries under general anaesthesia']","['dexmedetomidine', 'propofol', 'EC50 of propofol', 'fentanyl', 'dexmedetomidine 0.5 mcg/kg, fentanyl 1.5 mcg/kg and normal saline (control) respectively over 5\u2009min prior to induction with propofol TCI (Marsh model']","['hemodynamic profile', 'effect site concentration (Ce', 'EC50', 'propofol dose requirement and percentage change in haemodynamic during induction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0011017', 'cui_str': 'Day Care'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C1627892', 'cui_str': 'ug/kg'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1721089', 'cui_str': 'Marsh'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",120.0,0.154472,"We hypothesise that low dose dexmedetomidine will reduce the propofol requirement for induction with better haemodynamic profile compared with fentanyl. ","[{'ForeName': 'Venkata', 'Initials': 'V', 'LastName': 'Ganesh', 'Affiliation': 'Department of Anaesthesiology, Pain Medicine & Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Luthra', 'Affiliation': 'Department of Anaesthesia & Intensive Care, Post-Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Vamsidhar', 'Initials': 'V', 'LastName': 'Amburu', 'Affiliation': 'Department of Anaesthesia & Intensive Care, Post-Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'B Naveen', 'Initials': 'BN', 'LastName': 'Naik', 'Affiliation': 'Department of Anaesthesia & Intensive Care, Post-Graduate Institute of Medical Education and Research, Chandigarh, India. Electronic address: navin_amc@yahoo.com.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Department of Anaesthesia & Intensive Care, Post-Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'G D', 'Initials': 'GD', 'LastName': 'Puri', 'Affiliation': 'Department of Anaesthesia & Intensive Care, Post-Graduate Institute of Medical Education and Research, Chandigarh, India.'}]","Anaesthesia, critical care & pain medicine",['10.1016/j.accpm.2021.100815'] 2331,33640376,"Italian breakfast in mind: The effect of caffeine, carbohydrate and protein on physiological state, mood and cognitive performance.","Due to the bidirectional influence between eating and mental activity, there is a growing interest in the neurosciences in the potential of food to influence mental states. Breakfast is the most investigated meal since it is supposed to influence satiety, mood and cognitive performance for the rest of the day. However, there is insufficient consistency among studies to draw firm conclusions about the short-term influence of carbohydrates and proteins on self-reported physiological state and mood. In order to shed light on this topic, 40 young Italian adults were involved in a single-blind randomized counterbalanced crossover experiment, in which we asked them to report on a series of visuo-analogue scales their physiological (i.e., hunger, tiredness and thirst) and affective states (i.e., happiness, excitement, activeness and relaxation) and perform 2 computer-administered cognitive tasks (simple reaction time and forward digit span) before and after having breakfast with a bitter espresso coffee and a whole wheat or a protein croissant. Our data show that breakfast improves the self-reported mood and physiological state, and also short-term verbal memory assessed by means of the forward digit span: we suppose that both croissants and caffeine played an important role in such findings. As for the reaction times, the whole wheat croissant intake determined slower reaction time compared with the protein croissant, maybe due to the higher glycemic response induced by carbohydrate ingestion. Confirming the bidirectional relationship between mind and food intake, the present findings are significant for nutrition science, since mood, physiological state and cognitive performance play a substantial role in general well-being as well as in eating behavior.",2021,"Our data show that breakfast improves the self-reported mood and physiological state, and also short-term verbal memory assessed by means of the forward digit span: we suppose that both croissants and caffeine played an important role in such findings.","['40 young Italian adults', 'Italian breakfast in mind']","['2 computer-administered cognitive tasks (simple reaction time and forward digit span) before and after having breakfast with a bitter espresso coffee and a whole wheat or a protein croissant', 'caffeine, carbohydrate and protein']","['reaction time', 'physiological state, mood and cognitive performance']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0235290', 'cui_str': 'Taste bitter'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0038164', 'cui_str': 'Protein A'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",40.0,0.0189784,"Our data show that breakfast improves the self-reported mood and physiological state, and also short-term verbal memory assessed by means of the forward digit span: we suppose that both croissants and caffeine played an important role in such findings.","[{'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'Manippa', 'Affiliation': 'Department of Psychological, Health and Territorial Sciences, University G. ""d\'Annunzio"" of Chieti-Pescara, Chieti, Italy. Electronic address: valerio.manippa@unich.it.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Lupo', 'Affiliation': 'Department of Psychological, Health and Territorial Sciences, University G. ""d\'Annunzio"" of Chieti-Pescara, Chieti, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Tommasi', 'Affiliation': 'Department of Psychological, Health and Territorial Sciences, University G. ""d\'Annunzio"" of Chieti-Pescara, Chieti, Italy.'}, {'ForeName': 'Afredo', 'Initials': 'A', 'LastName': 'Brancucci', 'Affiliation': 'Department of Psychological, Health and Territorial Sciences, University G. ""d\'Annunzio"" of Chieti-Pescara, Chieti, Italy.'}]",Physiology & behavior,['10.1016/j.physbeh.2021.113371'] 2332,33646060,"The effect of platelet-rich plasma-fibrin glue dressing in combination with oral vitamin E and C for treatment of non-healing diabetic foot ulcers: a randomized, double-blind, parallel-group, clinical trial.","OBJECTIVE The current study assesses the effects of platelet-rich plasma-fibrin glue (PRP-FG) dressing along with oral vitamin E and C on wound healing and biochemical markers in patients with non-healing diabetic foot ulcers (non-healing DFU). METHODS This randomized controlled trial was performed on 25 patients with non-healing DFU. Patients were treated with PRP-FG dressing plus oral vitamin E and C (intervention group) or PRP-FG dressing plus placebo (control group) for 8 weeks. RESULTS Eight weeks after treatment, six wounds in the intervention group and two wounds in the control group were completely closed, and also wound size significantly reduced in both intervention and control groups ( p  < 0.05). This reduction in wound size was significantly greater in the intervention group compared to the control group ( p  = 0.019). Also, a significant decrease in prooxidant-antioxidant balance (PAB) , ESR, and hs-CRP was observed in the intervention group compared to the control group ( p  < 0.05). CONCLUSION Our results showed that PRP-FG dressing along with oral vitamin E and C could be used to increase wound healing in patients with non-healing DFU by enhancing the wound healing process and reducing oxidative stress. TRIAL REGISTRATION This trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT04315909).",2021,This reduction in wound size was significantly greater in the intervention group compared to the control group ( p = 0.019).,"['non-healing diabetic foot ulcers', 'patients with non-healing diabetic foot ulcers (non-healing DFU', 'twenty-five patients with non-healing DFU']","['PRP-FG dressing plus oral vitamin E and C (intervention group) or PRP-FG dressing plus placebo', 'platelet-rich plasma-fibrin glue dressing in combination with oral vitamin E and C', 'platelet-rich plasma-fibrin glue (PRP-FG) dressing along with oral vitamin E and C', 'placebo']","['wound healing and biochemical markers', 'wound size', 'wound healing', 'prooxidant-antioxidant balance (PAB) index, ESR, and hs-CRP']","[{'cui': 'C0205301', 'cui_str': 'Non-healed'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3715062', 'cui_str': '25'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0016004', 'cui_str': 'Autologous Fibrin Tissue Adhesive'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0013845', 'cui_str': 'Electron spin resonance measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",25.0,0.248596,This reduction in wound size was significantly greater in the intervention group compared to the control group ( p = 0.019).,"[{'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Yarahmadi', 'Affiliation': 'Department of Clinical Biochemistry, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammad-Hadi', 'Initials': 'MH', 'LastName': 'Saeed Modaghegh', 'Affiliation': 'Vascular and Endovascular Surgery Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Mostafavi-Pour', 'Affiliation': 'Department of Biochemistry, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Negar', 'Initials': 'N', 'LastName': 'Azarpira', 'Affiliation': 'Transplant Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Mousavian', 'Affiliation': 'Vascular and Endovascular Surgery Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Shokoufeh', 'Initials': 'S', 'LastName': 'Bonakdaran', 'Affiliation': 'Metabolic Syndrome Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Lida', 'Initials': 'L', 'LastName': 'Jarahi', 'Affiliation': 'Department of Community Medicine, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Samadi', 'Affiliation': 'Vascular and Endovascular Surgery Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Meghdad', 'Initials': 'M', 'LastName': 'Peimani', 'Affiliation': 'Vascular and Endovascular Surgery Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Daryoush', 'Initials': 'D', 'LastName': 'Hamidi Alamdari', 'Affiliation': 'Department of Clinical Biochemistry, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Expert opinion on biological therapy,['10.1080/14712598.2021.1897100'] 2333,33645253,Precision and accuracy of hyperglycemic clamps in a multicenter study.,"Application of glucose clamp methodologies in multicenter studies brings challenges for standardization. The Restoring Insulin Secretion (RISE) Consortium implemented a hyperglycemic clamp protocol across seven centers using a combination of technical and management approaches to achieve standardization. Two-stage hyperglycemic clamps with glucose targets of 200 mg/dL and >450 mg/dL were performed utilizing a centralized spreadsheet-based algorithm that guided dextrose infusion rates using bedside plasma glucose measurements. Clamp operators received initial and repeated training with ongoing feedback based on surveillance of clamp performance. The precision and accuracy of the achieved stage-specific glucose targets were evaluated, including differences by study center. We also evaluated robustness of the method to baseline physiologic differences and on-study treatment effects. The RISE approach produced high overall precision (3%-9% variance in achieved plasma glucose from target at various times across the procedure) and accuracy (SD < 10% overall). Statistically significant but numerically small differences in achieved target glucose concentrations were observed across study centers, within the magnitude of the observed technical variability. Variation of the achieved target glucose over time in placebo-treated individuals was low (<3% variation), and the method was robust to differences in baseline physiology (youth vs. adult, IGT vs. diabetes status) and differences in physiology induced by study treatments. The RISE approach to standardization of the hyperglycemic clamp methodology across multiple study centers produced technically excellent standardization of achieved glucose concentrations. This approach provides a reliable method for implementing glucose clamp methodology across multiple study centers. NEW & NOTEWORTHY The Restoring Insulin Secretion (RISE) study centers undertook hyperglycemic clamps using a simplified methodology and a decision guidance algorithm implemented in an easy-to-use spreadsheet. This approach, combined with active management including ongoing central data surveillance and routine feedback to study centers, produced technically excellent standardization of achieved glucose concentrations on repeat studies within and across study centers.",2021,"Variation of the achieved target glucose over time in placebo-treated individuals was low (<3% variation), and the method was robust to differences in baseline physiology (youth vs adult, IGT vs diabetes status) and to differences in physiology induced by study treatments. ",['Two- stage hyperglycemic clamps with glucose targets of 200 mg/dL and'],[],"['Restoring Insulin Secretion (RISE', 'target glucose concentrations', 'overall precision']","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]",[],"[{'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0717022,"Variation of the achieved target glucose over time in placebo-treated individuals was low (<3% variation), and the method was robust to differences in baseline physiology (youth vs adult, IGT vs diabetes status) and to differences in physiology induced by study treatments. ","[{'ForeName': 'Kieren J', 'Initials': 'KJ', 'LastName': 'Mather', 'Affiliation': 'Department of Medicine, School of Medicine, Indiana University, Indianapolis, Indiana.'}, {'ForeName': 'Ashley H', 'Initials': 'AH', 'LastName': 'Tjaden', 'Affiliation': 'The Biostatistics Center, Milken Institute School of Public Health, George Washington University, Washington, DC.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Hoehn', 'Affiliation': 'College of Osteopathic Medicine, Marian University, Indianapolis, Indiana.'}, {'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'Nadeau', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of Colorado Denver, Colorado.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Buchanan', 'Affiliation': 'Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': 'Department of Medicine, VA Puget Sound Health Care System, University of Washington, Seattle, Washington.'}, {'ForeName': 'Silva A', 'Initials': 'SA', 'LastName': 'Arslanian', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Caprio', 'Affiliation': 'Department of Pediatrics, School of Medicine, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Atkinson', 'Affiliation': 'Department of Medicine, VA Puget Sound Health Care System, University of Washington, Seattle, Washington.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Cree-Green', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of Colorado Denver, Colorado.'}, {'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Utzschneider', 'Affiliation': 'Department of Medicine, VA Puget Sound Health Care System, University of Washington, Seattle, Washington.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Edelstein', 'Affiliation': 'The Biostatistics Center, Milken Institute School of Public Health, George Washington University, Washington, DC.'}]",American journal of physiology. Endocrinology and metabolism,['10.1152/ajpendo.00598.2020'] 2334,33647900,Between Temperament and Psychopathology: Examples from Neuropharmacological Challenge Tests in Healthy Humans.,"BACKGROUND This paper tries to demonstrate that the questionnaire-based continuum between temperament traits and psychopathology can also be shown on the biochemical level. A common feature is the incapacity to adapt to external demands, as demonstrated by examples of disturbed hormone cycles as well as neurotransmitter (TM) responses related to affective and impulse control disorders. METHODS Pharmacological challenge tests performed in placebo-controlled balanced crossover experiments with consecutive challenges by serotonin (5-HT), noradrenaline (NA), and dopamine (DA) agonistic drugs were applied to healthy subjects, and individual responsivities of each TM system assessed by respective cortisol and prolactin responses were related to questionnaire-based facets of depressiveness and impulsivity, respectively. RESULTS The depression-related traits ""Fatigue"" and ""Physical Anhedonia"" were characterized by low and late responses to DA stimulation as opposed to ""Social Anhedonia,"" which rather mirrored the pattern of schizophrenia. Reward-related and premature responding-related impulsivity represented by high scores on ""Disinhibition"" and ""Motor Impulsivity,"" respectively, as well as the questionnaire-based components of attention deficit hyperactivity disorder, ""Cognitive"" and ""Motor Impulsivity,"" could be discriminated by their patterns of DA/NA responses. 5-HT responses suggested that instead of the expected low availability of 5-HT claimed to be associated with impulse control disorders, low NA responses indicated lack of inhibition in impulsivity and high NA responses in depression-related ""Anhedonia"" indicated suppression of approach motivation. CONCLUSIONS In spite of the flaws of pharmacological challenge tests, they may be suitable for demonstrating similarities in TM affinities between psychopathological disturbances and respective temperament traits and for separating sub-entities of larger disease spectra.",2021,"The depression-related traits ""Fatigue"" and ""Physical Anhedonia"" were characterized by low and late responses to DA stimulation as opposed to ""Social Anhedonia,"" which rather mirrored the pattern of schizophrenia.",['Healthy Humans'],"['placebo', 'serotonin (5-HT), noradrenaline (NA), and dopamine (DA) agonistic drugs']","['depression-related traits ""Fatigue"" and ""Physical Anhedonia']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3178804', 'cui_str': 'Physical Anhedonia'}]",,0.0172185,"The depression-related traits ""Fatigue"" and ""Physical Anhedonia"" were characterized by low and late responses to DA stimulation as opposed to ""Social Anhedonia,"" which rather mirrored the pattern of schizophrenia.","[{'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Netter', 'Affiliation': 'Department of Psychology, University of Gießen, Gießen, Germany, petra.netter@psychol.uni-giessen.de.'}]",Neuropsychobiology,['10.1159/000514074'] 2335,33647246,"Safety and efficacy of intensive blood pressure lowering after successful endovascular therapy in acute ischaemic stroke (BP-TARGET): a multicentre, open-label, randomised controlled trial.","BACKGROUND High systolic blood pressure after successful endovascular therapy for acute ischaemic stroke is associated with increased risk of intraparenchymal haemorrhage. However, no randomised controlled trials are available to guide optimal management. We therefore aimed to assess whether an intensive systolic blood pressure target resulted in reduced rates of intraparenchymal haemorrhage compared with a standard systolic blood pressure target. METHODS We did a multicentre, open-label, randomised controlled trial at four academic hospital centres in France. Eligible individuals were adults (aged ≥18 years) with an acute ischaemic stroke due to a large-vessel occlusion that was successfully treated with endovascular therapy. Patients were randomly assigned (1:1) to either an intensive systolic blood pressure target group (100-129 mm Hg) or a standard care systolic blood pressure target group (130-185 mm Hg), by means of a central web-based procedure, stratified by centre and intravenous thrombolysis use before endovascular therapy. In both groups, the target systolic blood pressure had to be achieved within 1 h after randomisation and maintained for 24 h with intravenous blood pressure lowering treatments. The primary outcome was the rate of radiographic intraparenchymal haemorrhage at 24-36 h and the primary safety outcome was the occurrence of hypotension. Analyses were done on an intention-to-treat basis. BP-TARGET is registered with ClinicalTrials.gov, number NCT03160677, and the trial is closed at all participating sites. FINDINGS Between June 21, 2017, and Sept 27, 2019, 324 patients were enrolled in the four participating stroke centres: 162 patients were randomly assigned to the intensive target group and 162 to the standard target group. Four (2%) of 162 patients were excluded from the intensive target group and two (1%) of 162 from the standard target group for withdrawal of consent or legal reasons. The mean systolic blood pressure during the first 24 h after reperfusion was 128 mm Hg (SD 11) in the intensive target group and 138 mm Hg (17) in the standard target group. The primary outcome was observed in 65 (42%) of 154 patients in the intensive target group and 68 (43%) of 157 in the standard target group on brain CT within 24-36 h after reperfusion] (adjusted odds ratio 0·96, 95% CI 0·60-1·51; p=0·84). Hypotensive events were not significantly different between both groups and occurred in 12 (8%) of 158 patients in the intensive target and five (3%) of 160 in the standard target group. Mortality within the first week after randomisation occurred in 11 (7%) of 158 patients in the intensive target group and in seven (4%) of 160 in the standard target group. INTERPRETATION An intensive systolic blood pressure target of 100-129 mm Hg after successful endovascular therapy did not reduce radiographic intraparenchymal haemorrhage rates at 24-36 h as compared with a standard care systolic blood pressure target of 130-185 mm Hg. Notably, these results are applicable to patients with successful reperfusion and systolic blood pressures of more than 130 mm Hg at the end of procedure. Further studies are needed to understand the association between blood pressure and outcomes after reperfusion. FUNDING French Health Ministry.",2021,"Mortality within the first week after randomisation occurred in 11 (7%) of 158 patients in the intensive target group and in seven (4%) of 160 in the standard target group. ","['acute ischaemic stroke (BP-TARGET', '324 patients were enrolled in the four participating stroke centres: 162 patients', 'four academic hospital centres in France', 'acute ischaemic stroke', 'Eligible individuals were adults (aged ≥18 years) with an acute ischaemic stroke due to a large-vessel occlusion that was successfully treated with', '162 patients were excluded from the intensive target group and two (1%) of 162 from the standard target group for withdrawal of consent or legal reasons', 'Between June 21, 2017, and Sept 27, 2019']","['endovascular therapy', 'intensive blood pressure lowering after successful endovascular therapy', 'intensive systolic blood pressure target group (100-129 mm Hg) or a standard care systolic blood pressure target group']","['mean systolic blood pressure', 'Mortality', 'Hypotensive events', 'target systolic blood pressure', 'radiographic intraparenchymal haemorrhage rates', 'rate of radiographic intraparenchymal haemorrhage', 'rates of intraparenchymal haemorrhage', 'occurrence of hypotension', 'systolic blood pressures', 'brain CT']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0225990', 'cui_str': 'Large blood vessel structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1301860', 'cui_str': 'Legal'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1277632', 'cui_str': 'Target systolic blood pressure'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0412585', 'cui_str': 'Computerized axial tomography of brain'}]",324.0,0.308852,"Mortality within the first week after randomisation occurred in 11 (7%) of 158 patients in the intensive target group and in seven (4%) of 160 in the standard target group. ","[{'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Mazighi', 'Affiliation': 'Department of Interventional Neuroradiology, Rothschild Foundation Hospital, Paris, France; Laboratory of Vascular Translational Science, INSERM, Paris, France; Université de Paris, Paris, France; FHU NeuroVasc, Assistance Publique-Hôpitaux de Paris, Paris, France. Electronic address: mmazighi@for.paris.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Richard', 'Affiliation': 'Department of Neurology, Stroke Unit, University Hospital of Nancy, Nancy, France; Université de Lorraine, INSERM, Nancy, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Lapergue', 'Affiliation': 'Department of Neurology, Foch Hospital, University Versailles Saint-Quentin en Yvelines, Suresnes, France.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Sibon', 'Affiliation': 'Stroke Unit, CHU Bordeaux, Université de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Gory', 'Affiliation': 'Department of Diagnostic and Therapeutic Neuroradiology, CHRU-Nancy, Université de Lorraine, Nancy, France; Université de Lorraine, IADI, INSERM U1254, Nancy, France.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Berge', 'Affiliation': 'Interventional and Diagnostic Neuroradiology Department, Bordeaux University Hospital, Bordeaux, France.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Consoli', 'Affiliation': 'Department of Neuroradiology, Foch Hospital, University Versailles Saint-Quentin en Yvelines, Suresnes, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Labreuche', 'Affiliation': 'Department of Biostatistics, University Lille, CHU de Lille, Lille, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Olivot', 'Affiliation': 'Stroke Unit, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Broderick', 'Affiliation': 'Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati, OH, USA.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Duhamel', 'Affiliation': 'Department of Biostatistics, University Lille, CHU de Lille, Lille, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Touze', 'Affiliation': 'Department of Neurology, Université Caen Normandie, INSERM U1237, CHU Caen Normandie, Caen, France.'}, {'ForeName': 'Adnan I', 'Initials': 'AI', 'LastName': 'Qureshi', 'Affiliation': ""Department of Neurology, University of Missouri, Women's and Children's Hospital, Columbia, MO, USA.""}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Yavchitz', 'Affiliation': 'Department of Clinical Research, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Escalard', 'Affiliation': 'Department of Interventional Neuroradiology, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Desilles', 'Affiliation': 'Department of Interventional Neuroradiology, Rothschild Foundation Hospital, Paris, France; Laboratory of Vascular Translational Science, INSERM, Paris, France; Université de Paris, Paris, France; FHU NeuroVasc, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Hocine', 'Initials': 'H', 'LastName': 'Redjem', 'Affiliation': 'Department of Interventional Neuroradiology, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'Stanislas', 'Initials': 'S', 'LastName': 'Smajda', 'Affiliation': 'Department of Interventional Neuroradiology, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fahed', 'Affiliation': 'Division of Neurology and Department of Medical Imaging, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Solène', 'Initials': 'S', 'LastName': 'Hébert', 'Affiliation': 'Department of Interventional Neuroradiology, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Maïer', 'Affiliation': 'Department of Interventional Neuroradiology, Rothschild Foundation Hospital, Paris, France; Laboratory of Vascular Translational Science, INSERM, Paris, France; Université de Paris, Paris, France; FHU NeuroVasc, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Delvoye', 'Affiliation': 'Department of Interventional Neuroradiology, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'Perrine', 'Initials': 'P', 'LastName': 'Boursin', 'Affiliation': 'Department of Interventional Neuroradiology, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'Malek Ben', 'Initials': 'MB', 'LastName': 'Maacha', 'Affiliation': 'Department of Clinical Research, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Obadia', 'Affiliation': 'Stroke Unit, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Sabben', 'Affiliation': 'Stroke Unit, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Blanc', 'Affiliation': 'Department of Interventional Neuroradiology, Rothschild Foundation Hospital, Paris, France; Laboratory of Vascular Translational Science, INSERM, Paris, France; FHU NeuroVasc, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Savatovsky', 'Affiliation': 'Diagnostic Imaging and Radiology Department, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Piotin', 'Affiliation': 'Department of Interventional Neuroradiology, Rothschild Foundation Hospital, Paris, France; Laboratory of Vascular Translational Science, INSERM, Paris, France; FHU NeuroVasc, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30483-X'] 2336,33650299,Effect of selenium on thyroid autoimmunity and regulatory T cells in patients with Hashimoto's thyroiditis: A prospective randomized-controlled trial.,"Selenium (Se) is an essential trace element in human. Recent studies of Se supplementation on the effect of Hashimoto's thyroiditis (HT) have been reported, but the exact benefit is unclear as well as the underlying immunologic mechanism. We aimed to evaluate the clinical effect of Se supplement in patients with HT, and explore the potential mechanism against thyroid autoimmunity. A prospective, randomized-controlled study was performed in patients with HT assigned to two groups. Se-treated group (n = 43) received selenious yeast tablet (SYT) for 6 months, whereas no treatment in control group (n = 47). The primary outcome is the change of thyroid peroxidase antibody (TPOAb) or thyroglobulin antibody (TGAb). Second, thyroid function, urinary iodine, Se, Glutathione peroxidase3 (GPx3), and Selenoprotein P1 (SePP1) levels were measured during the SYT treatment. Meanwhile, regulatory T cells (Tregs) and their subsets activated Tregs (aTregs), resting Tregs, and secreting Tregs, as well as Helios and PD-1 expression on these cells were also detected. The results showed that SYT treatment significantly decreased TPOAb, TGAb, and thyroid stimulating hormone (TSH) levels, accompanied with the increased Se, GPx3, and SePP1, compared with the control group. Subgroup analysis revealed that subclinical HT may benefit more from this treatment in the decrease of TSH levels by interaction test. Moreover, the percentage of aTregs, Helios/Tregs, and Helios/aTregs were significantly higher in the Se-treated group than control. In conclusion, Se supplementation may have a beneficial effect on thyroid autoantibodies and thyroid function by increasing the antioxidant activity and upregulating the activated Treg cells.",2021,"The results showed that Se supplementation significantly decreased thyroid peroxidase antibody (TPOAb), thyroglobulin antibody (TGAb), and thyroid stimulating hormone (TSH) levels, accompanied with the increased Se, GPx3 and SePP1, compared with control group.","['HT patients assigned to two groups', 'patients with thyroiditis', 'HT patients']","['selenium (Se) supplementation', 'selenium (Se', 'Selenium', 'selenium']","['thyroid function, urinary iodine (UI), Se, Glutathione peroxidase3 (GPx3) and Selenoprotein P1 (SePP1) levels', 'TSH levels', 'Se, GPx3 and SePP1', 'thyroid autoimmunity and regulatory T cells', 'Meanwhile, regulatory T cells (Tregs) and their subsets activated Tregs (aTregs), resting Tregs (rTregs) and secreting Tregs (sTregs), as well as Helios and PD-1 expression', 'percentage of aTregs, Helios/Tregs, and Helios/aTregs', 'changement of thyroid antibody (TPOAb or TGAb', 'thyroid peroxidase antibody (TPOAb), thyroglobulin antibody (TGAb), and thyroid stimulating hormone (TSH) levels']","[{'cui': 'C0677607', 'cui_str': 'Hashimoto thyroiditis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040147', 'cui_str': 'Thyroiditis'}]","[{'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0141948', 'cui_str': 'Selenoprotein P1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement'}, {'cui': 'C0004364', 'cui_str': 'Autoimmune disease'}, {'cui': 'C0039198', 'cui_str': 'Regulatory T-Lymphocytes'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0700384', 'cui_str': 'Thyroid antibody'}, {'cui': 'C0076635', 'cui_str': 'Thyroid microsomal antibody'}, {'cui': 'C0201512', 'cui_str': 'Thyroglobulin antibody measurement'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}]",,0.0220163,"The results showed that Se supplementation significantly decreased thyroid peroxidase antibody (TPOAb), thyroglobulin antibody (TGAb), and thyroid stimulating hormone (TSH) levels, accompanied with the increased Se, GPx3 and SePP1, compared with control group.","[{'ForeName': 'Yifang', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Wenwen', 'Initials': 'W', 'LastName': 'Feng', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Huanhuan', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xuqin', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiaoyun', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Wensong', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmacy, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yaoqi', 'Initials': 'Y', 'LastName': 'Ge', 'Affiliation': 'Department of Geriatrics, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Geriatrics, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Cui', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}]",Clinical and translational science,['10.1111/cts.12993'] 2337,33653964,Hypofractionated versus conventionally fractionated image-guided volumetric-modulated arc radiotherapy for localized prostate cancer: a phase II randomized trial from China.,"PURPOSE To determine the safety of hypofractionated imaging-guided (IG) volumetric-modulated arc radiotherapy (IG-VMAT; 70 Gy/28 fractions over 5.5 weeks) versus conventionally fractionated regimen (IG-VMAT; 80 Gy/40 fractions over 8 weeks) in Chinese patients with localized prostate cancer. METHOD In this randomized non-comparative phase II trial, 92 patients with localized prostate cancer were assigned to receive either hypofractionated IG-VMAT (HFRT; 70 Gy/2.5Gy/28f) or conventionally fractionated IG-VMAT (CFRT; 80 Gy/2Gy/40f). Primary endpoint was grade 2 or higher late gastrointestinal (GI) and genitourinary (GU) toxicity at 2 years. The GI/GU toxicity and biochemical relapse-free survival (bRFS) were compared between the two treatment groups. RESULTS Median follow-up was 26 months. The incidence of grade 2 or higher late GI/GU toxicity was low in both groups; the 5-year cumulative incidence of Radiation Therapy Oncology Group grade 2 or higher GI/GU toxicity at 2 years was 7.6% with HFRT versus 10.3% with CFRT ( P = 0.707). Biochemical control was not significantly different between the two groups; the 2-year bRFS was 94.6% for HFRT versus 95.0% for CFRT ( P = 0.704). CONCLUSION Hypofractionated IG-VMAT appears to be equivalent to conventionally fractionated IG-VMAT in terms of toxicity in Chinese patients with localized prostate cancer.",2021,Hypofractionated IG-VMAT appears to be equivalent to conventionally fractionated IG-VMAT in terms of toxicity in Chinese patients with localized prostate cancer.,"['Chinese patients with localized prostate cancer', 'localized prostate cancer', '92 patients with localized prostate cancer']","['Hypofractionated versus conventionally fractionated image-guided volumetric-modulated arc radiotherapy', 'hypofractionated IG-VMAT (HFRT; 70 Gy/2.5Gy/28f) or conventionally fractionated IG-VMAT', 'Hypofractionated IG-VMAT', 'HFRT', 'hypofractionated imaging-guided (IG) volumetric-modulated arc radiotherapy (IG-VMAT']","['incidence of grade 2 or higher late GI/GU toxicity', 'GI/GU toxicity', 'grade 2 or higher late gastrointestinal (GI) and genitourinary (GU) toxicity', '2-year bRFS', 'GI/GU toxicity and biochemical relapse-free survival (bRFS', 'Biochemical control']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C3489631', 'cui_str': 'Intensity-Modulated Arc Therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",92.0,0.0402588,Hypofractionated IG-VMAT appears to be equivalent to conventionally fractionated IG-VMAT in terms of toxicity in Chinese patients with localized prostate cancer.,"[{'ForeName': 'Qiu-Zi', 'Initials': 'QZ', 'LastName': 'Zhong', 'Affiliation': 'Department of Radiation Oncology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, P. R. China.'}, {'ForeName': 'Xiu', 'Initials': 'X', 'LastName': 'Xia', 'Affiliation': 'Department of Radiation Oncology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, P. R. China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': 'Department of Radiation Oncology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, P. R. China.'}, {'ForeName': 'Yong-Gang', 'Initials': 'YG', 'LastName': 'Xu', 'Affiliation': 'Department of Radiation Oncology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, P. R. China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Zhao', 'Affiliation': 'Department of Radiation Oncology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, P. R. China.'}, {'ForeName': 'Qin-Hong', 'Initials': 'QH', 'LastName': 'Wu', 'Affiliation': 'Department of Radiation Oncology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, P. R. China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, P. R. China.'}, {'ForeName': 'Hai-Lei', 'Initials': 'HL', 'LastName': 'Lin', 'Affiliation': 'Department of Radiation Oncology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, P. R. China.'}, {'ForeName': 'Xiang-Yan', 'Initials': 'XY', 'LastName': 'Sha', 'Affiliation': 'Department of Radiation Oncology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, P. R. China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Department of Radiation Oncology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, P. R. China.'}, {'ForeName': 'Gao-Feng', 'Initials': 'GF', 'LastName': 'Li', 'Affiliation': 'Department of Radiation Oncology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, P. R. China.'}]",Aging,['10.18632/aging.202551'] 2338,33652160,Addition of vaginal isosorbide mononitrate for labor induction in pregnancies complicated by hypertensive diseases of pregnancy: a randomized controlled trial.,"BACKGROUND Pregnancies complicated by hypertensive disease of pregnancy often require labor induction. Rates of cesarean delivery range from 15% to 60% in this population. Nitric oxide deficiency has been shown to underlay the pathophysiology of preeclampsia, and nitric oxide promotes cervical ripening. OBJECTIVE We hypothesized that addition of vaginal isosorbide mononitrate for labor induction could decrease the rate of cesarean delivery in pregnancies with hypertensive disease of pregnancy. STUDY DESIGN This study was a double-blind, placebo-controlled, randomized trial of patients with singleton pregnancy at ≥24 weeks' gestation undergoing labor induction for hypertensive diseases of pregnancy between November 2017 and February 2020. Participants were eligible if their Bishop score was <6 and if their cervical dilation was ≤2 cm. In addition, participants received up to 3 doses of 40 mg isosorbide mononitrate in addition to misoprostol for labor induction. Labor management was per healthcare provider preference. The primary outcome was rate of cesarean delivery. Secondary outcomes included the length of labor and frequency of intrapartum adverse events, including the use of intrapartum antihypertensive agents. RESULTS Here, 89 women were randomized to the isosorbide mononitrate group, and 87 women were randomized to the placebo group. Cesarean delivery rates were similar in both groups (32.6% vs 25.3%; relative risk, 1.29; 95% confidence interval, 0.81-2.06; P=.39). Maternal headache was increased in patients exposed to isosorbide mononitrate (42.7% vs 31%; relative risk, 1.52; 95% confidence interval, 1.04-2.23; P=.04). Clinical chorioamnionitis was increased in the placebo group (0% vs 8%; P=.02). Secondary outcomes were similar between groups. CONCLUSION The addition of vaginal isosorbide mononitrate for labor induction in pregnancies complicated by hypertensive disease of pregnancy did not result in fewer cesarean deliveries.",2021,"Clinical chorioamnionitis was increased in the placebo group (0% vs 8%, P=0.02).","['patients with singleton pregnancy ≥ 24 weeks undergoing induction for HDP between 11/2017-2/2020', '89 women', 'pregnancies with HDP', 'Participants were eligible if Bishop score was less than 6 and cervical dilation ≤2cm']","['vaginal isosorbide mononitrate (IMN', 'misoprostol', 'placebo', 'IMN', 'vaginal IMN']","['length of labor and frequency of intrapartum adverse events including the use of intrapartum antihypertensive agents', 'Clinical chorioamnionitis', 'cesarean deliveries', 'Rates of cesarean delivery (CD) range', 'CD rates', 'rate of CD', 'rate of cesarean delivery', 'Maternal headache']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2225498', 'cui_str': 'Bishop score'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0064079', 'cui_str': 'isosorbide mononitrate'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0566679', 'cui_str': 'Duration of labor'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0008495', 'cui_str': 'Chorioamnionitis'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0018681', 'cui_str': 'Headache'}]",89.0,0.72749,"Clinical chorioamnionitis was increased in the placebo group (0% vs 8%, P=0.02).","[{'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Gee', 'Affiliation': 'Department of Obstetrics and Gynecology, The Ohio State University College of Medicine, Columbus, OH. Electronic address: stephen.gee@osumc.edu.'}, {'ForeName': 'Marwan', 'Initials': 'M', 'LastName': ""Ma'ayeh"", 'Affiliation': 'Department of Obstetrics and Gynecology, The Ohio State University College of Medicine, Columbus, OH.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Cackovic', 'Affiliation': 'Department of Obstetrics and Gynecology, The Ohio State University College of Medicine, Columbus, OH.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Samuels', 'Affiliation': 'Department of Obstetrics and Gynecology, The Ohio State University College of Medicine, Columbus, OH.'}, {'ForeName': 'Stephen F', 'Initials': 'SF', 'LastName': 'Thung', 'Affiliation': 'Department of Obstetrics and Gynecology, The Ohio State University College of Medicine, Columbus, OH.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Landon', 'Affiliation': 'Department of Obstetrics and Gynecology, The Ohio State University College of Medicine, Columbus, OH.'}, {'ForeName': 'Kara M', 'Initials': 'KM', 'LastName': 'Rood', 'Affiliation': 'Department of Obstetrics and Gynecology, The Ohio State University College of Medicine, Columbus, OH.'}]",American journal of obstetrics & gynecology MFM,['10.1016/j.ajogmf.2021.100343'] 2339,33651675,"Passive Prophylactic Administration with a Single Dose of Anti-Fel d 1 Monoclonal Antibodies REGN1908-1909 in Cat Allergen-Induced Allergic Rhinitis: A Randomized, Double-blind, Placebo Controlled Trial.","RATIONALE Sensitization to Felis domesticus allergen 1 (Fel d 1) contributes to persistent allergic rhinitis and asthma. Existing treatment options for cat allergy, including allergen immunotherapy (AIT) are only moderately effective, and AIT has limited use due to safety concerns. OBJECTIVES To explore the relationship among the pharmaokinteic, clinical, and immunological effects of REGN1908-1909 (anti-Fel d 1 monoclonal antibodies) in patients after treatment. METHODS Patients received REGN1908-1909 (n=36) or placebo (n=37) in a phase 1b study. Fel d 1-induced basophil and IgE-facilitated allergen binding responses were evaluated at baseline and days 8, 29 and 85. Cytokine and chemokine levels in nasal fluids were measured. REGN1908-1909 inhibition of allergen-IgE binding in patient serum was evaluated. MEASUREMENTS AND MAIN RESULTS Peak serum drug concentrations were concordant with maximal observed clinical response. The anti-Fel d 1 IgE/cat-dander IgE ratio in pretreatment serum correlated with Total Nasal Symptom Score improvement. The allergen neutralizing capacity of REGN1908-1909 was observed in serum and nasal fluid, and was detected in an inhibition assay. Type-2 cytokines (IL-4, IL-5 and IL-13) and chemokines (CCL17/TARC, CCL5/RANTES) in nasal fluid were inhibited in REGN1908-1909-treated patients compared to placebo (all P < 0.05); IL-13 and IL-5 levels correlated with TNSS improvement. Ex vivo assays demonstrated that REGN1908 and REGN1909 combined was more potent than each alone for inhibiting FcεRI- and FcεRII (CD23)-mediated allergic responses and subsequent T-cell activation. CONCLUSION Single passive dose administration of Fel d 1-neutralizing IgG antibodies improved nasal symptoms in cat-allergic patients, and was underscored by suppression of FcεRI-, FcεRII- and Th2-mediated allergic responses. Clinical trial registration available at www.clinicaltrials.gov, ID: NCT02127801 This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License 4.0 (http://creativecommons.org/licenses/by-nc-nd/4.0/).",2021,The anti-Fel d 1 IgE/cat-dander IgE ratio in pretreatment serum correlated with Total Nasal Symptom Score improvement.,"['cat-allergic patients', 'patients after treatment', 'Patients received REGN1908-1909 (n=36) or', 'n=37) in a phase 1b study', '1909 in Cat Allergen-Induced Allergic Rhinitis']","['Monoclonal Antibodies REGN1908', 'Placebo', 'Fel d', 'placebo']","['inhibiting FcεRI- and FcεRII (CD23)-mediated allergic responses and subsequent T-cell activation', 'Cytokine and chemokine levels', 'Peak serum drug concentrations', 'nasal symptoms', 'IL-13 and IL-5 levels', 'Total Nasal Symptom Score improvement', 'Type-2 cytokines (IL-4, IL-5 and IL-13) and chemokines (CCL17/TARC, CCL5/RANTES) in nasal fluid']","[{'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}]","[{'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0272199', 'cui_str': 'Familial hemophagocytic lymphohistiocytosis'}]","[{'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C1527304', 'cui_str': 'Allergic reaction'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0214743', 'cui_str': 'Interleukin 13'}, {'cui': 'C0021759', 'cui_str': 'Interleukin-5'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C1444694', 'cui_str': 'Nasal fluid'}]",,0.275005,The anti-Fel d 1 IgE/cat-dander IgE ratio in pretreatment serum correlated with Total Nasal Symptom Score improvement.,"[{'ForeName': 'Mohamed H', 'Initials': 'MH', 'LastName': 'Shamji', 'Affiliation': 'Imperial College London, Allergy & Clinical Immunology, London, United Kingdom of Great Britain and Northern Ireland; m.shamji@imperial.ac.uk.'}, {'ForeName': 'Iesha', 'Initials': 'I', 'LastName': 'Singh', 'Affiliation': 'Imperial College London, Allergy & Clinical Immunology, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Janice A', 'Initials': 'JA', 'LastName': 'Layhadi', 'Affiliation': 'Imperial College London, Allergy & Clinical Immunology, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Ito', 'Affiliation': 'Imperial College London, Allergy & Clinical Immunology, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Angeliki', 'Initials': 'A', 'LastName': 'Karamani', 'Affiliation': 'Imperial College London, Allergy & Clinical Immunology, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Lubna', 'Initials': 'L', 'LastName': 'Kouser', 'Affiliation': 'Imperial College London, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Hanisah', 'Initials': 'H', 'LastName': 'Sharif', 'Affiliation': 'Imperial College London, Allergy & Clinical Immunology, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Jiaqian', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Imperial College London, Allergy & Clinical Immunology, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Sava', 'Initials': 'S', 'LastName': 'Handijiev', 'Affiliation': 'Imperial College London, Allergy & Clinical Immunology, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Rebecca V', 'Initials': 'RV', 'LastName': 'Parkin', 'Affiliation': 'Imperial College London, 4615, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Durham', 'Affiliation': 'National Heart & Lung Institute, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Kostic', 'Affiliation': 'Regeneron Pharmaceuticals Inc, 7845, Tarrytown, New York, United States.'}, {'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Orengo', 'Affiliation': 'Regeneron Pharmaceuticals Inc, 7845, Immunology & Inflammation, Tarrytown, New York, United States.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'DeVeaux', 'Affiliation': 'Regeneron Pharmaceuticals Inc, 7845, Tarrytown, New York, United States.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Kamal', 'Affiliation': 'Regeneron Pharmaceuticals Inc, 7845, Tarrytown, New York, United States.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Stahl', 'Affiliation': 'Regeneron Pharmaceuticals Inc, 7845, Tarrytown, New York, United States.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Yancopoulos', 'Affiliation': 'Regeneron Pharmaceuticals Inc, 7845, Immunology & Inflammation, Tarrytown, New York, United States.'}, {'ForeName': 'Claire Q', 'Initials': 'CQ', 'LastName': 'Wang', 'Affiliation': 'Regeneron Pharmaceuticals Inc, 7845, Tarrytown, New York, United States.'}, {'ForeName': 'Allen R', 'Initials': 'AR', 'LastName': 'Radin', 'Affiliation': 'Regeneron Pharmaceuticals Inc, 7845, Tarrytown, New York, United States.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202011-4107OC'] 2340,33651671,"Safety and Efficacy of B-Cell Depletion with Rituximab for the Treatment of Systemic Sclerosis Associated Pulmonary Arterial Hypertension: A Multi-center, Double-blind, Randomized, Placebo-controlled Trial.","RATIONALE Systemic sclerosis-pulmonary arterial hypertension (SSc-PAH) is one of the most prevalent and deadly forms of PAH. B cells may contribute to SSc pathogenesis. OBJECTIVE We investigated the safety and efficacy of B-cell depletion for SSc-PAH. METHODS AND MEASUREMENTS In an NIH-sponsored, multi-center, double-blinded, randomized, placebo-controlled, proof-of-concept trial, 57 SSc-PAH patients on stable-dose standard medical therapy received two infusions of 1000 mg of rituximab or placebo administered two weeks apart. The primary outcome measure was the change in six-minute walk distance (6MWD) at 24 weeks. Secondary endpoints included safety and invasive hemodynamics. We applied a machine learning approach to predict drug-responsiveness. MAIN RESULTS We randomized 57 subjects from 2010-2018. In the primary analysis, using data through week 24, the adjusted mean change in 6MWD at 24 weeks favored the treatment arm but did not reach statistical significance (23.6±11.1m vs. 0.5±9.7m, p=0.12). While a negative study, when data through week 48 were also considered, the estimated change in 6MWD at week 24 was 25.5±8.8m for rituximab and 0.4±7.4m for placebo (p=0.03). Rituximab treatment appeared to be safe and well tolerated. Low levels of rheumatoid factor (RF), IL-12, and IL-17 were sensitive and specific as favorable predictors of a rituximab response as measured by an improved 6MWD (ROC AUC 0.88-0.95). CONCLUSIONS B cell depletion therapy is a potentially effective and safe adjuvant treatment for SSc-PAH. Future studies in these patients can confirm whether the identified biomarkers predict rituximab-responsiveness. Clinical trial registration available at www.clinicaltrials.gov, ID: NCT01086540.",2021,"Low levels of rheumatoid factor (RF), IL-12, and IL-17 were sensitive and specific as favorable predictors of a rituximab response as measured by an improved 6MWD (ROC AUC 0.88-0.95). ","['57 subjects from 2010-2018', 'Systemic Sclerosis Associated Pulmonary Arterial Hypertension']","['machine learning approach', 'placebo', 'rituximab or placebo', 'B-Cell Depletion with Rituximab', 'Placebo', 'B cell depletion therapy', 'Rituximab']","['Low levels of rheumatoid factor (RF), IL-12, and IL-17', '6MWD', 'safety and invasive hemodynamics', 'safe and well tolerated', 'change in six-minute walk distance (6MWD']","[{'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary arterial hypertension'}]","[{'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C1171324', 'cui_str': 'B-cell depletion therapy'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035448', 'cui_str': 'Rheumatoid factor'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}]",57.0,0.756652,"Low levels of rheumatoid factor (RF), IL-12, and IL-17 were sensitive and specific as favorable predictors of a rituximab response as measured by an improved 6MWD (ROC AUC 0.88-0.95). ","[{'ForeName': 'Roham T', 'Initials': 'RT', 'LastName': 'Zamanian', 'Affiliation': 'Stanford University Medical Center, Department of Medicine, Stanfod, California, United States; zamanian@stanford.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Badesch', 'Affiliation': 'University of Colorado, Medicine, Aurora, Colorado, United States.'}, {'ForeName': 'Lorinda', 'Initials': 'L', 'LastName': 'Chung', 'Affiliation': 'Stanford University School of Medicine, Medicine/Rheumatology, Palo Alto, California, United States.'}, {'ForeName': 'Robyn T', 'Initials': 'RT', 'LastName': 'Domsic', 'Affiliation': 'University of Pittsburgh School of Medicine, 12317, Pittsburgh, Pennsylvania, United States.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Medsger', 'Affiliation': 'University of Pittsburgh, 6614, Division of Rheumatology and Clinical Immunology, Pittsburgh, Pennsylvania, United States.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Pinckney', 'Affiliation': 'Rho, Federal Systems Division, Durham, North Carolina, United States.'}, {'ForeName': 'Lynette', 'Initials': 'L', 'LastName': 'Keyes-Elstein', 'Affiliation': 'Rho, Federal Systems Division, Durham, North Carolina, United States.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': ""D'Aveta"", 'Affiliation': 'Rho, Federal Systems Division, Durham, North Carolina, United States.'}, {'ForeName': 'Meagan', 'Initials': 'M', 'LastName': 'Spychala', 'Affiliation': 'Rho, Federal Systems Division, Durham, North Carolina, United States.'}, {'ForeName': 'R James', 'Initials': 'RJ', 'LastName': 'White', 'Affiliation': 'University of Rochester, Pulmonary & Critical Care Medicine, Rochester, New York, United States.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Hassoun', 'Affiliation': 'Johns Hopkins University School of Medicine, Medicine - Pulmonary and Critical Care Medicine, Baltimore, Maryland, United States.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Torres', 'Affiliation': 'UT Southwestern, Medicine, Dallas, Texas, United States.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Sweatt', 'Affiliation': 'Stanford University, 6429, Medicine - Pulmonary and Critical Care, Stanford, California, United States.'}, {'ForeName': 'Jerry A', 'Initials': 'JA', 'LastName': 'Molitor', 'Affiliation': 'University of Minnesota, 5635, Minneapolis, Minnesota, United States.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Khanna', 'Affiliation': 'University of Michigan, 1259, Ann Arbor, Michigan, United States.'}, {'ForeName': 'Holden', 'Initials': 'H', 'LastName': 'Maecker', 'Affiliation': 'Stanford University School of Medicine, 10624, Stanford, California, United States.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Welch', 'Affiliation': 'NIAID DIR, 469049, Bethesda, Maryland, United States.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Goldmuntz', 'Affiliation': 'NIAID DIR, 469049, Bethesda, Maryland, United States.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nicolls', 'Affiliation': 'VA Palo Alto, Stanford University, Medicine, Palo Alto, California, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202009-3481OC'] 2341,33637412,"Effect and safety of Chinese herbal medicine granules in patients with severe coronavirus disease 2019 in Wuhan, China: a retrospective, single-center study with propensity score matching.","BACKGROUND Chinese herbal medicine (CHM) has been used for severe illness caused by coronavirus disease 2019 (COVID-19), but its treatment effects and safety are unclear. PURPOSE This study reviews the effect and safety of CHM granules in the treatment of patients with severe COVID-19. METHODS We conducteda single-center, retrospective study on patients with severe COVID-19 in a designated hospital in Wuhan from January 15, 2020 to March 30, 2020. The propensity score matching (PSM) was used to assess the effect and safety of the treatment using CHM granules. The ratio of patients who received treatment with CHM granules combined with usual care and those who received usual care alone was 1:1. The primary outcome was the time to clinical improvement within 28 days, defined as the time taken for the patients' health to show improvement by decline of two categories (from the baseline) on a modified six-category ordinal scale, or to be dischargedfrom the hospital before Day 28. RESULTS Using PSM, 43 patients (45% male) aged 65.6 (57-70) yearsfrom each group were exactly matched. No significant difference was observed in clinical improvement of patients treated with CHM granules compared with those who received usual (p = 0.851). However, the use of CHM granules reduced the 28-day mortality (p = 0.049) and shortened the duration of fever (4 days vs. 7 days, p = 0.002). The differences in the duration of cough and dyspnea and the difference in lung lesion ratio on computerized tomography scans were not significant.Commonly,patients in the CHM group had an increased D-dimer level (p = 0.036). CONCLUSION Forpatients with severe COVID-19, CHM granules, combined with usual care, showed no improvement beyond usual care alone. However, the use of CHM granules reduced the 28-day mortality rate and the time to fever alleviation. Nevertheless, CHM granules may be associated with high risk of fibrinolysis.",2021,"Commonly,patients in the CHM group had an increased D-dimer level (p = 0.036). ","['patients with severe COVID-19 in a designated hospital in Wuhan from January 15, 2020 to March 30, 2020', 'patients with severe coronavirus disease 2019 in Wuhan, China', 'patients with severe COVID-19', '43 patients (45% male) aged 65.6 (57-70']","['Chinese herbal medicine granules', 'CHM granules combined with usual care and those who received usual care alone', 'Chinese herbal medicine (CHM']","['28-day mortality rate', 'duration of fever', 'clinical improvement', 'duration of cough and dyspnea', ""time to clinical improvement within 28 days, defined as the time taken for the patients' health"", '28-day mortality', 'lung lesion ratio on computerized tomography scans', 'D-dimer level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C1273412', 'cui_str': 'Chinese herbal medicine'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0577916', 'cui_str': 'Lesion of lung'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0907756,"Commonly,patients in the CHM group had an increased D-dimer level (p = 0.036). ","[{'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Emergency, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China; Department of Global Public Health, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Yuntao', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Emergency, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China; Guangdong Provincial Key Laboratory of Research on Emergency in TCM, Guangzhou, China.'}, {'ForeName': 'Qingquan', 'Initials': 'Q', 'LastName': 'Lv', 'Affiliation': 'Department of Medical Administration, Wuhan Hankou Hospital, Wuhan, China.'}, {'ForeName': 'Danwen', 'Initials': 'D', 'LastName': 'Zheng', 'Affiliation': 'Department of Emergency, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Key Unit of Methodology in Clinical Research, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Wenwei', 'Initials': 'W', 'LastName': 'Ouyang', 'Affiliation': 'Department of Global Public Health, Karolinska Institute, Stockholm, Sweden; Key Unit of Methodology in Clinical Research, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Banghan', 'Initials': 'B', 'LastName': 'Ding', 'Affiliation': 'Department of Emergency, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zou', 'Affiliation': 'Intensive Care Unit, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Yan', 'Affiliation': 'Department of Internal Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Zhuhai, China.'}, {'ForeName': 'Tianzhu', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Zhuhai, China.'}, {'ForeName': 'Chicheng', 'Initials': 'C', 'LastName': 'Fu', 'Affiliation': 'Shanghai Aitrox Technology Corporation Limited, Shanghai, China.'}, {'ForeName': 'Qu', 'Initials': 'Q', 'LastName': 'Fang', 'Affiliation': 'Shanghai Aitrox Technology Corporation Limited, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Shanghai Aitrox Technology Corporation Limited, Shanghai, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Department of Emergency, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Ailan', 'Initials': 'A', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Cecilia Stålsby', 'Initials': 'CS', 'LastName': 'Lundborg', 'Affiliation': 'Department of Global Public Health, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Jianwen', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Department of Neurology, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. Electronic address: jianwen_guo@qq.com.'}, {'ForeName': 'Zehuai', 'Initials': 'Z', 'LastName': 'Wen', 'Affiliation': 'Key Unit of Methodology in Clinical Research, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. Electronic address: wenzh@gzucm.edu.cn.'}, {'ForeName': 'Zhongde', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Emergency, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China; Guangdong Provincial Key Laboratory of Research on Emergency in TCM, Guangzhou, China; State Key Laboratory of Dampness Syndrome of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. Electronic address: doctorzzd99@163.com.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2020.153404'] 2342,33650179,Weekly carfilzomib plus cyclophosphamide and dexamethasone in the treatment of relapsed/refractory multiple myeloma: Final results from the MCRN-003/MYX.1 single arm phase II trial.,"The MCRN-003/CCTGMYX.1 is a single arm phase II trial of weekly carfilzomib, cyclophosphamide and dexamethasone (wKCd), exploring a convenient immunomodulator (IMiD)-free regimen in relapsed myeloma. Weekly carfilzomib (20/70 mg/m 2 ), dexamethasone 40 mg and cyclophosphamide 300 mg/m 2 was delivered over 28-day cycles. The primary endpoint was overall response after four cycles. Secondary endpoints included toxicity, response depth, PFS and OS. Exploratory endpoints included the impact of cytogenetics, prior therapy exposure and serum free light chain (sFLC) escape; 76 patients were accrued. The ORR was 85% (68% ≥very good partial response [VGPR] and 29% ≥complete response [CR]). The median OS and PFS were 27 and 17 months respectively. High-risk cytogenetics conferred a worse ORR (75% vs. 97%, p = .013) and median OS (18 months vs. NR, p = .002) with a trend toward a worse median PFS (14 vs. 22 months, p = .06). Prior proteasome inhibitor (PI) or lenalidomide did not influence OS or PFS. The sFLC was noted in 15% of patients with a median PFS of 17 months when included as a progression event. The most common ≥ grade 3 non-hematologic adverse events were infectious (40%), vascular (17%) and cardiac (15%). The wKCD is a safe and effective regimen in relapse, especially for patients ineligible for lenalidomide-based therapies.",2021,"High-risk cytogenetics conferred a worse ORR (75% vs 97%, p = 0.013) and median OS (18 months vs NR, p = 0.002) with a trend toward a worse median PFS (14 vs 22 months, p = 0.06).","['Refractory Multiple Myeloma', '76 patients were accrued', 'patients ineligible for lenalidomide-based therapies']","['Weekly Carfilzomib plus Cyclophosphamide and Dexamethasone', 'Weekly carfilzomib', 'wKCD', 'dexamethasone 40 mg and cyclophosphamide', 'carfilzomib, cyclophosphamide and dexamethasone (wKCd']","['median OS and PFS', 'toxicity, response depth, PFS and OS', 'sFLC escape', 'impact of cytogenetics, prior therapy exposure and serum free light chain (sFLC) escape', 'overall response', 'ORR', 'median PFS', 'median OS']","[{'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C2001856', 'cui_str': 'carfilzomib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0010802', 'cui_str': 'Cytogenetics'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0806492', 'cui_str': 'Free immunoglobulin light chain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",76.0,0.0722321,"High-risk cytogenetics conferred a worse ORR (75% vs 97%, p = 0.013) and median OS (18 months vs NR, p = 0.002) with a trend toward a worse median PFS (14 vs 22 months, p = 0.06).","[{'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Venner', 'Affiliation': 'The Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'LeBlanc', 'Affiliation': ""CIUSSS de l'Est de l'Ile de Montréal, Université de Montréal, Montreal, Quebec, Canada.""}, {'ForeName': 'Irwindeep', 'Initials': 'I', 'LastName': 'Sandhu', 'Affiliation': 'The Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Darrell', 'Initials': 'D', 'LastName': 'White', 'Affiliation': 'Queen Elizabeth II Health Sciences Centre, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Belch', 'Affiliation': 'The Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Donna E', 'Initials': 'DE', 'LastName': 'Reece', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Dolan', 'Affiliation': 'University of New Brunswick, Saint John Regional Hospital, Saint John, New Brunswick, Canada.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Lalancette', 'Affiliation': 'Hotel Dieu Hospital, Quebec City, Quebec, Canada.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Louzada', 'Affiliation': 'London Regional Cancer Centre, University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Kew', 'Affiliation': 'The Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Arleigh', 'Initials': 'A', 'LastName': 'McCurdy', 'Affiliation': 'The Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Monteith', 'Affiliation': ""Queen's University, Canadian Cancer Trials Group, Kingston, Ontario, Canada.""}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Reiman', 'Affiliation': 'University of New Brunswick, Saint John Regional Hospital, Saint John, New Brunswick, Canada.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'McDonald', 'Affiliation': ""Queen's University, Canadian Cancer Trials Group, Kingston, Ontario, Canada.""}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Sherry', 'Affiliation': ""Queen's University, Canadian Cancer Trials Group, Kingston, Ontario, Canada.""}, {'ForeName': 'Engin', 'Initials': 'E', 'LastName': 'Gul', 'Affiliation': 'Canadian Myeloma Research Group (formerly the Myeloma Canada Research Network), Vaughan, Ontario, Canada.'}, {'ForeName': 'Bingshu E', 'Initials': 'BE', 'LastName': 'Chen', 'Affiliation': ""Queen's University, Canadian Cancer Trials Group, Kingston, Ontario, Canada.""}, {'ForeName': 'Annette E', 'Initials': 'AE', 'LastName': 'Hay', 'Affiliation': ""Queen's University, Canadian Cancer Trials Group, Kingston, Ontario, Canada.""}]",American journal of hematology,['10.1002/ajh.26147'] 2343,33650089,"Transcutaneous Electrical Acupoint Stimulation Combined with Dexamethasone and Tropisetron Prevents Postoperative Nausea and Vomiting in Female Patients Undergoing Laparoscopic Sleeve Gastrectomy: a Prospective, Randomized Controlled Trial.","BACKGROUND Despite the administration of prophylactic antiemetics, some patients who undergo laparoscopic sleeve gastrectomy (LSG) remain at high risk for postoperative nausea and vomiting (PONV). Although many trials have been conducted, the effectiveness of transcutaneous electrical acupoint stimulation (TEAS) on the prevention of PONV remains unknown. METHODS Sixty-two female patients undergoing elective LSG were randomly assigned to the TEAS combined with dexamethasone and tropisetron (TEAS group, n = 31) or dexamethasone and tropisetron (control group, n = 31) groups. The incidence and severity of PONV, as well as the need for rescue antiemetics, were collected within 48 h after surgery. RESULTS The patients in both groups had similar clinical characteristics and underwent the same surgical procedure. In the TEAS group, 13 patients (41.9%) had PONV within 48 h after LSG compared to 24 patients (77.4%) in the control group (P = 0.004, relative risk: 0.39 [0.19, 0.80]). The severity of PONV differed significantly between groups, with five patients (16.1%) in the TEAS group and 15 patients (48%) in the control group experiencing clinically important PONV (P = 0.007, relative risk: 0.62 [0.42, 0.90]). Moreover, fewer patients required antiemetic rescue medication in the TEAS group compared with the control group (29.0% vs. 58.1%, P = 0.021). CONCLUSION Multimodal antiemetic prophylaxis consisting of TEAS and antiemetics was effective in reducing PONV incidence and intensity in high-risk patients undergoing LSG.",2021,"The severity of PONV differed significantly between groups, with five patients (16.1%) in the TEAS group and 15 patients (48%) in the control group experiencing clinically important PONV (P = 0.007, relative risk: 0.62 [0.42, 0.90]).","['Sixty-two female patients undergoing elective LSG', 'Female Patients', 'patients who undergo laparoscopic sleeve gastrectomy (LSG) remain at high risk for postoperative nausea and vomiting (PONV', 'high-risk patients undergoing LSG']","['TEAS and antiemetics', 'TEAS', 'Dexamethasone and Tropisetron', 'Laparoscopic Sleeve Gastrectomy', 'TEAS combined with dexamethasone and tropisetron (TEAS group, n\u2009=\u200931) or dexamethasone and tropisetron', 'transcutaneous electrical acupoint stimulation (TEAS']","['PONV', 'Postoperative Nausea and Vomiting', 'incidence and severity of PONV', 'severity of PONV', 'PONV incidence and intensity', 'antiemetic rescue medication']","[{'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0063322', 'cui_str': 'tropisetron'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",62.0,0.0914821,"The severity of PONV differed significantly between groups, with five patients (16.1%) in the TEAS group and 15 patients (48%) in the control group experiencing clinically important PONV (P = 0.007, relative risk: 0.62 [0.42, 0.90]).","[{'ForeName': 'Qiuju', 'Initials': 'Q', 'LastName': 'Xiong', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Chongqing Medical University, Youyi Road 1, Yuzhong District, Chongqing, 400016, People's Republic of China.""}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Min', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Chongqing Medical University, Youyi Road 1, Yuzhong District, Chongqing, 400016, People's Republic of China. ms89011068@163.com.""}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Wei', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Chongqing Medical University, Youyi Road 1, Yuzhong District, Chongqing, 400016, People's Republic of China.""}, {'ForeName': 'Yanmei', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""College of Traditional Chinese Medicine, Chongqing Medical University, Chongqing, 401331, People's Republic of China.""}, {'ForeName': 'Jingyue', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Chongqing Medical University, Youyi Road 1, Yuzhong District, Chongqing, 400016, People's Republic of China.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Chongqing Medical University, Youyi Road 1, Yuzhong District, Chongqing, 400016, People's Republic of China.""}, {'ForeName': 'Menghua', 'Initials': 'M', 'LastName': 'Zeng', 'Affiliation': ""Department of Gastrointestinal Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, People's Republic of China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zou', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Chongqing Medical University, Youyi Road 1, Yuzhong District, Chongqing, 400016, People's Republic of China.""}]",Obesity surgery,['10.1007/s11695-020-05205-9'] 2344,33653009,Acceptability and Feasibility of a 13-Week Pilot Randomised Controlled Trial Testing the Effects of Incremental Doses of Beetroot Juice in Overweight and Obese Older Adults.,"Nitrate-rich food can increase nitric oxide production and improve vascular and brain functions. This study examines the feasibility of a randomised controlled trial (RCT) testing the effects of prolonged consumption of different doses of dietary nitrate (NO 3 - ) in the form of beetroot juice (BJ) in overweight and obese older participants. A single-blind, four-arm parallel pilot RCT was conducted in 62 overweight and obese (30.4 ± 4 kg/m 2 ) older participants (mean ± standard deviation (SD), 66 ± 4 years). Participants were randomized to: (1) high-NO 3 - (HN: 2 × 70 mL BJ/day) (2) medium-NO 3 - (MN: 70 mL BJ/day), (3) low-NO 3 - (LN: 70 mL BJ on alternate days) or (4) Placebo (PL: 70 mL of NO 3 - -depleted BJ on alternate days), for 13 weeks. Compliance was checked by a daily log of consumed BJ, NO 3 - intake, and by measuring NO 3 - and NO 2 - concentrations in plasma, saliva, and urine samples. Fifty participants completed the study. Self-reported compliance to the interventions was >90%. There were significant positive linear relationships between NO 3 - dose and the increase in plasma and urinary NO 3 - concentration (R 2 = 0.71, P < 0.001 and R 2 = 0.46 P < 0.001, respectively), but relationships between NO 3 - dose and changes in salivary NO 3 - and NO 2 - were non-linear (R 2 = 0.35, P = 0.002 and R 2 = 0.23, P = 0.007, respectively). The results confirm the feasibility of prolonged BJ supplementation in older overweight and obese adults.",2021,"NO 3 - and NO 2 - were non-linear (R 2 = 0.35, P = 0.002 and R 2 = 0.23, P = 0.007, respectively).","['62 overweight and obese (30.4 ± 4 kg/m 2 ) older participants (mean ± standard deviation (SD), 66 ± 4 years', 'older overweight and obese adults', 'overweight and obese older participants', 'Overweight and Obese Older Adults', 'Fifty participants completed the study']","['Nitrate-rich food', 'Placebo (PL: 70 mL of NO 3 - -depleted BJ', 'BJ supplementation', 'Beetroot Juice', 'dietary nitrate (NO 3 - ', 'beetroot juice (BJ']","['plasma, saliva, and urine samples', 'salivary', 'plasma and urinary NO 3 - concentration', 'nitric oxide production and improve vascular and brain functions']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0453861', 'cui_str': 'Rich food'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",62.0,0.0785749,"NO 3 - and NO 2 - were non-linear (R 2 = 0.35, P = 0.002 and R 2 = 0.23, P = 0.007, respectively).","[{'ForeName': 'Abrar M', 'Initials': 'AM', 'LastName': 'Babateen', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle Upon Tyne NE2 4HH, UK.'}, {'ForeName': 'Oliver M', 'Initials': 'OM', 'LastName': 'Shannon', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle Upon Tyne NE2 4HH, UK.'}, {'ForeName': 'Gerard M', 'Initials': 'GM', 'LastName': ""O'Brien"", 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle Upon Tyne NE2 4HH, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Okello', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle Upon Tyne NE2 4HH, UK.'}, {'ForeName': 'Anmar A', 'Initials': 'AA', 'LastName': 'Khan', 'Affiliation': 'Faculty of Applied Medical Sciences, Clinical Nutrition Department, Umm Al-Qura University, Makkah 21421, Saudi Arabia.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Rubele', 'Affiliation': 'Department of Geriatrics, St Bortolo Hospital, Vicenza, 37030 Verona, Italy.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Wightman', 'Affiliation': 'Brain Performance and Nutrition Research Centre, Northumbria University, Newcastle Upon Tyne NE1 8ST, UK.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Smith', 'Affiliation': 'Brain Performance and Nutrition Research Centre, Northumbria University, Newcastle Upon Tyne NE1 8ST, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'McMahon', 'Affiliation': 'School of Human Movement and Nutrition Sciences, University of Queensland, St. Lucia, QLD 4067, Australia.'}, {'ForeName': 'Dilara', 'Initials': 'D', 'LastName': 'Olgacer', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle Upon Tyne NE2 4HH, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Koehl', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle Upon Tyne NE2 4HH, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Fostier', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle Upon Tyne NE2 4HH, UK.'}, {'ForeName': 'Inês', 'Initials': 'I', 'LastName': 'Mendes', 'Affiliation': 'Endocrinology and Nutrition Department, Divino Espirito Santo Hospital, D.Manuel I Avenue, 9500-370 Azores, Portugal.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kennedy', 'Affiliation': 'Brain Performance and Nutrition Research Centre, Northumbria University, Newcastle Upon Tyne NE1 8ST, UK.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Mathers', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle Upon Tyne NE2 4HH, UK.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Siervo', 'Affiliation': ""School of Life Sciences, Queen's Medical Centre,The University of Nottingham Medical School, Nottingham NG7 2UH, UK.""}]",Nutrients,['10.3390/nu13030769'] 2345,33652910,"The Impact of Decaffeinated Green Tea Extract on Fat Oxidation, Body Composition and Cardio-Metabolic Health in Overweight, Recreationally Active Individuals.","This study investigated the effect of decaffeinated green tea extract (dGTE), with or without antioxidant nutrients, on fat oxidation, body composition and cardio-metabolic health measures in overweight individuals engaged in regular exercise. Twenty-seven participants (20 females, 7 males; body mass: 77.5 ± 10.5 kg; body mass index: 27.4 ± 3.0 kg·m 2 ; peak oxygen uptake (O 2peak ): 30.2 ± 5.8 mL·kg -1 ·min -1 ) were randomly assigned, in a double-blinded manner, either: dGTE (400 mg·d -1 (-)-epigallocatechin-3-gallate (EGCG), n = 9); a novel dGTE+ (400 mg·d -1 EGCG, quercetin (50 mg·d -1 ) and α-lipoic acid (LA, 150 mg·d -1 ), n = 9); or placebo (PL, n = 9) for 8 weeks, whilst maintaining standardised, aerobic exercise. Fat oxidation ('FAT MAX ' and steady state exercise protocols), body composition, cardio-metabolic and blood measures (serum glucose, insulin, leptin, adiponectin, glycerol, free fatty acids, total cholesterol, high [HDL-c] and low-density lipoprotein cholesterol [LDL-c], triglycerides, liver enzymes and bilirubin) were assessed at baseline, week 4 and 8. Following 8 weeks of dGTE+, maximal fat oxidation (MFO) significantly improved from 154.4 ± 20.6 to 224.6 ± 23.2 mg·min -1 ( p = 0.009), along with a 22.5% increase in the exercise intensity at which fat oxidation was deemed negligible (FAT MIN ; 67.6 ± 3.6%O 2peak , p = 0.003). Steady state exercise substrate utilisation also improved for dGTE+ only, with respiratory exchange ratio reducing from 0.94 ± 0.01 at week 4, to 0.89 ± 0.01 at week 8 ( p = 0.004). This corresponded with a significant increase in the contribution of fat to energy expenditure for dGTE+ from 21.0 ± 4.1% at week 4, to 34.6 ± 4.7% at week 8 ( p = 0.006). LDL-c was also lower (normalised fold change of -0.09 ± 0.06) for dGTE+ by week 8 ( p = 0.038). No other significant effects were found in any group. Eight weeks of dGTE+ improved MFO and substrate utilisation during exercise, and lowered LDL-c. However, body composition and cardio-metabolic markers in healthy, overweight individuals who maintained regular physical activity were largely unaffected by dGTE.",2021,LDL-c was also lower (normalised fold change of -0.09 ± 0.06) for dGTE+ by week 8 ( p = 0.038).,"['Overweight, Recreationally Active Individuals', 'overweight individuals engaged in regular exercise', 'Twenty-seven participants (20 females, 7 males; body mass: 77.5 ± 10.5 kg; body mass index: 27.4 ± 3.0 kg·m 2 ']","['dGTE', 'Decaffeinated Green Tea Extract', 'dGTE (400 mg·d -1 (-)-epigallocatechin-3-gallate (EGCG), n = 9); a novel dGTE+ (400 mg·d -1 EGCG, quercetin (50 mg·d -1 ) and α-lipoic acid (LA, 150 mg·d -1 ), n = 9); or placebo (PL, n = 9) for 8 weeks, whilst maintaining standardised, aerobic exercise', 'decaffeinated green tea extract (dGTE), with or without antioxidant nutrients']","['Fat Oxidation, Body Composition and Cardio-Metabolic Health', 'contribution of fat to energy expenditure', 'Steady state exercise substrate utilisation', 'MFO and substrate utilisation', 'body composition and cardio-metabolic markers', 'peak oxygen uptake', ""Fat oxidation ('FAT MAX ' and steady state exercise protocols), body composition, cardio-metabolic and blood measures (serum glucose, insulin, leptin, adiponectin, glycerol, free fatty acids, total cholesterol, high [HDL-c] and low-density lipoprotein cholesterol [LDL-c], triglycerides, liver enzymes and bilirubin"", 'LDL-c', 'fat oxidation, body composition and cardio-metabolic health measures', 'maximal fat oxidation (MFO', 'exercise intensity at which fat oxidation']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C5192328', 'cui_str': '27.4'}]","[{'cui': 'C1704263', 'cui_str': 'Green Tea Extract'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0059438', 'cui_str': 'epigallocatechin gallate'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1384640', 'cui_str': 'Green tea'}, {'cui': 'C0034392', 'cui_str': 'Quercetin'}, {'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",,0.121376,LDL-c was also lower (normalised fold change of -0.09 ± 0.06) for dGTE+ by week 8 ( p = 0.038).,"[{'ForeName': 'Justin D', 'Initials': 'JD', 'LastName': 'Roberts', 'Affiliation': 'Cambridge Centre for Sport and Exercise Sciences, School of Psychology and Sport Science, Anglia Ruskin University, Cambridge CB1 1PT, UK.'}, {'ForeName': 'Ashley G B', 'Initials': 'AGB', 'LastName': 'Willmott', 'Affiliation': 'Cambridge Centre for Sport and Exercise Sciences, School of Psychology and Sport Science, Anglia Ruskin University, Cambridge CB1 1PT, UK.'}, {'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Beasley', 'Affiliation': 'Cambridge Centre for Sport and Exercise Sciences, School of Psychology and Sport Science, Anglia Ruskin University, Cambridge CB1 1PT, UK.'}, {'ForeName': 'Mariette', 'Initials': 'M', 'LastName': 'Boal', 'Affiliation': 'Cambridge Centre for Sport and Exercise Sciences, School of Psychology and Sport Science, Anglia Ruskin University, Cambridge CB1 1PT, UK.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Davies', 'Affiliation': 'Cambridge Centre for Sport and Exercise Sciences, School of Psychology and Sport Science, Anglia Ruskin University, Cambridge CB1 1PT, UK.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Martin', 'Affiliation': 'Cambridge Centre for Sport and Exercise Sciences, School of Psychology and Sport Science, Anglia Ruskin University, Cambridge CB1 1PT, UK.'}, {'ForeName': 'Havovi', 'Initials': 'H', 'LastName': 'Chichger', 'Affiliation': 'School of Life Sciences, Anglia Ruskin University, Cambridge CB1 1PT, UK.'}, {'ForeName': 'Lata', 'Initials': 'L', 'LastName': 'Gautam', 'Affiliation': 'School of Life Sciences, Anglia Ruskin University, Cambridge CB1 1PT, UK.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Del Coso', 'Affiliation': 'Centre for Sport Studies, Rey Juan Carlos University, 28943 Fuenlabrada, Spain.'}]",Nutrients,['10.3390/nu13030764'] 2346,33657920,Combined aerobic and resistance training improves physical and executive functions in women with systemic lupus erythematosus.,"OBJECTIVES Exercise is considered as an adjuvant therapeutic modality to alleviate symptoms of several rheumatic diseases. However, data regarding the benefits of exercise to patients with systemic lupus erythematosus (SLE) are relatively scant. METHODS This study aimed to assess the effects of regular, moderate-intensity, aerobic exercise combined with resistance training on women with SLE who had no regular exercise. Patients were recruited and allocated into either the exercise or control group by their willingness. Patients in the exercise group (n = 12) underwent 12 weeks of combined exercise (five days per week), whereas those in the control group (n = 11) maintained their usual lifestyle. RESULTS At baseline, there were no between-group differences in body composition, disease activity, two-kilometer walking test, and executive function test. After the combined exercise intervention for 12 weeks, significant improvements of both fitness index and reaction time to the stimuli in the go/no-go test were observed in the exercise group, but not in the control group. The disease activities in both study groups did not change significantly at the end of the study period. CONCLUSION Our results suggest that regular moderate-intensity aerobic exercise combined with resistance training improves the physical and executive functions of SLE patients without exacerbating disease activity.",2021,"At baseline, there were no between-group differences in body composition, disease activity, two-kilometer walking test, and executive function test.","['patients with systemic lupus erythematosus (SLE', 'SLE patients without exacerbating disease activity', 'women with systemic lupus erythematosus', 'women with SLE who had no regular exercise']","['regular moderate-intensity aerobic exercise combined with resistance training', 'control group (n\u2009=\u200911) maintained their usual lifestyle', 'combined exercise', 'regular, moderate-intensity, aerobic exercise combined with resistance training', 'combined exercise intervention', 'Combined aerobic and resistance training', 'exercise or control group by their willingness']","['body composition, disease activity, two-kilometer walking test, and executive function test', 'physical and executive functions', 'disease activities', 'fitness index and reaction time to the stimuli in the go/no-go test']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0436331', 'cui_str': 'Symptom aggravating factors'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439198', 'cui_str': 'km'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]",12.0,0.0247753,"At baseline, there were no between-group differences in body composition, disease activity, two-kilometer walking test, and executive function test.","[{'ForeName': 'Victoria Py', 'Initials': 'VP', 'LastName': 'Kao', 'Affiliation': 'Division of Allergy, Immunology & Rheumatology, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Hualien, Taiwan.'}, {'ForeName': 'Huei-Jhen', 'Initials': 'HJ', 'LastName': 'Wen', 'Affiliation': 'Center of Physical Education, Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Yu-Jen', 'Initials': 'YJ', 'LastName': 'Pan', 'Affiliation': 'Division of Allergy, Immunology & Rheumatology, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Hualien, Taiwan.'}, {'ForeName': 'Chia-Sheng', 'Initials': 'CS', 'LastName': 'Pai', 'Affiliation': 'Division of Allergy, Immunology & Rheumatology, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Hualien, Taiwan.'}, {'ForeName': 'Shih-Tzu', 'Initials': 'ST', 'LastName': 'Tsai', 'Affiliation': 'Division of Allergy, Immunology & Rheumatology, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Hualien, Taiwan.'}, {'ForeName': 'Kuei-Ying', 'Initials': 'KY', 'LastName': 'Su', 'Affiliation': 'Division of Allergy, Immunology & Rheumatology, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Hualien, Taiwan.'}]",Lupus,['10.1177/0961203321998749'] 2347,33657901,Spine Treatment Appraisal Report (STAR): Does Riluzole Improve Outcomes in Patients Undergoing Decompression Surgery for Degenerative Cervical Myelopathy?,"Fehlings MG, Badhiwala JH, Ahn H, et al. Safety and efficacy of riluzole in patients undergoing decompressive surgery for degenerative cervical myelopathy (CSM-Protect): a multicentre, double-blind, placebo-controlled, randomised, phase 3 trial. Lancet Neurol . 2020.",2021,"Fehlings MG, Badhiwala JH, Ahn H, et al. Safety and efficacy of riluzole in patients undergoing decompressive surgery for degenerative cervical myelopathy (CSM-Protect): a multicentre, double-blind, placebo-controlled, randomised, phase 3 trial. ","['Patients Undergoing Decompression Surgery for Degenerative Cervical Myelopathy', 'patients undergoing decompressive surgery for degenerative cervical myelopathy (CSM-Protect']","['Spine Treatment Appraisal Report (STAR', 'Riluzole', 'riluzole', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022983', 'cui_str': 'Laminectomy'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0149645', 'cui_str': 'Cervical myelopathy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4521841', 'cui_str': 'US Military enlisted E9'}]","[{'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}, {'cui': 'C0073379', 'cui_str': 'Riluzole'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.259243,"Fehlings MG, Badhiwala JH, Ahn H, et al. Safety and efficacy of riluzole in patients undergoing decompressive surgery for degenerative cervical myelopathy (CSM-Protect): a multicentre, double-blind, placebo-controlled, randomised, phase 3 trial. ","[{'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Dettori', 'Affiliation': 'Spectrum Research, Steilacoom, WA, USA.'}]",Global spine journal,['10.1177/2192568221997401'] 2348,33657755,The effects of whole-body vibration on EMG activity of the lower body muscles in supine static bridge position.,"OBJECTIVES The purpose of the current study was to firstly examine the effects of different whole-body vibration (WBV) frequencies in the lower-body muscles when applied simultaneously during a bridge exercise. Secondly, determine if there were any sex differences in the lower-body muscles of WBV during the bridge. METHODS Seven females and 7 males completed 2 familiarization and 1 test sessions. In the test session participants were randomized to complete one 30 s bout of a bridge exercise for 3 separate conditions followed by 3-min of rest. The 3 conditions (a) No-WBV (without WBV); (b) WBV-30 (30 Hz, low amplitude); (c) WBV-50 (50 Hz, low amplitude) were performed on a WBV platform. Muscle activity of the biceps femoris (BF), semitendinosus (ST), gluteus maximus (Gmax), multifidus muscle (MF) muscles were measured. RESULTS Muscle activity was increased with WBV in the BF and ST muscles at WBV-30 and WBV-50 conditions (p<0.05) vs. no-WBV. During No-WBV and WBV-50 conditions, males had a higher biceps femoris activity compared to females for (p<0.05) 45 and 27 %, respectively; however, during all conditions females had a high level of Gmax activity (57%) than males (p<0.05). CONCLUSION Additional vibration at 30 and 50 Hz during the bridge exercise could be a useful method to enhance hamstring muscle activity.",2021,"During No-WBV and WBV-50 conditions, males had a higher biceps femoris activity compared to females for (p<0.05) 45 and 27 %, respectively; however, during all conditions females had a high level of Gmax activity (57%) than males (p<0.05). ","['supine static bridge position', 'Seven females and 7 males completed 2 familiarization and 1 test sessions']","['bridge exercise', 'whole-body vibration']","['high level of Gmax activity', 'WBV (without WBV); (b) WBV-30', 'hamstring muscle activity', 'Muscle activity', 'Muscle activity of the biceps femoris (BF), semitendinosus (ST), gluteus maximus (Gmax), multifidus muscle (MF) muscles', 'biceps femoris activity']","[{'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0444378', 'cui_str': 'Bridging position'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0454350', 'cui_str': 'Bridging exercise'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0224424', 'cui_str': 'Structure of gluteus maximus muscle'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0224449', 'cui_str': 'Biceps femoris muscle structure'}, {'cui': 'C0224453', 'cui_str': 'Semitendinosus muscle structure'}, {'cui': 'C0224319', 'cui_str': 'Structure of multifidus muscle'}]",,0.0168473,"During No-WBV and WBV-50 conditions, males had a higher biceps femoris activity compared to females for (p<0.05) 45 and 27 %, respectively; however, during all conditions females had a high level of Gmax activity (57%) than males (p<0.05). ","[{'ForeName': 'Pedro J', 'Initials': 'PJ', 'LastName': 'Marín', 'Affiliation': 'CYMO Research Institute, Valladolid, Spain.'}, {'ForeName': 'Darryl J', 'Initials': 'DJ', 'LastName': 'Cochrane', 'Affiliation': 'School of Sport, Exercise & Nutrition, Massey University, New Zealand.'}]",Journal of musculoskeletal & neuronal interactions,[] 2349,33657754,"Cross training effects of non-paralytic dorsiflexion muscle strengthening exercise on paralytic dorsiflexor muscle activity, gait ability, and balancing ability in patients with chronic stroke: A randomized, controlled, pilot trial.","OBJECTIVE To investigate the effects of non-paralytic dorsiflexion muscle strengthening exercise on functional abilities in chronic hemiplegic patients after stroke. METHODS A total of 21 patients with chronic stroke underwent dorsiflexion muscle strengthening exercise (MST) 5 times a week for 6 weeks (the experimental group, MST to non-paralytic dorsiflexion muscles, n=11; the control group, MST to paralytic dorsiflexion muscles; n=10). Paralytic dorsiflexor muscle activities (DFA) and 10 m walking tests (10MWT) and timed up and go tests (TUG) were measured before and after intervention. RESULTS A significant increase in DFA was observed after intervention in the experimental and control groups (p<0.05) (experimental 886.6% for reference voluntary contraction (RVC), control 931.6% for RVC). TUG and 10MWT results showed significant reductions post-intervention in the experimental and control groups (experimental group -5.6 sec, control -4.8 sec; experimental group -3.1 sec, control, -3.9 sec; respectively). No significant intergroup difference was observed between changes in DFA or between changes in TUG and 10MWT results after intervention (p>.05). CONCLUSION Strengthening exercise performed on non-paralytic dorsiflexion muscles had positive cross-training effects on paralytic dorsiflexor muscle activities, balance abilities, and walking abilities in patients with chronic stroke.",2021,"No significant intergroup difference was observed between changes in DFA or between changes in TUG and 10MWT results after intervention (p>.05). ","['patients with chronic stroke', 'chronic hemiplegic patients after stroke', '21 patients with chronic stroke']","['Strengthening exercise', 'non-paralytic dorsiflexion muscle strengthening exercise', 'dorsiflexion muscle strengthening exercise (MST']","['paralytic dorsiflexor muscle activities, balance abilities, and walking abilities', 'functional abilities', 'Paralytic dorsiflexor muscle activities (DFA) and 10 m walking tests (10MWT) and timed up and go tests (TUG', 'paralytic dorsiflexor muscle activity, gait ability, and balancing ability', 'DFA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0016928', 'cui_str': 'Gait'}]",21.0,0.0144399,"No significant intergroup difference was observed between changes in DFA or between changes in TUG and 10MWT results after intervention (p>.05). ","[{'ForeName': 'Sung-Chan', 'Initials': 'SC', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, Graduate School of Daejeon University, Republic of Korea.'}, {'ForeName': 'Jun-Nam', 'Initials': 'JN', 'LastName': 'Ryu', 'Affiliation': 'Department of Physical Therapy, Yeoju University, Republic of Korea.'}, {'ForeName': 'Se-Jung', 'Initials': 'SJ', 'LastName': 'Oh', 'Affiliation': 'Department of Physical Therapy, Graduate School of Daejeon University, Republic of Korea.'}, {'ForeName': 'Yong-Jun', 'Initials': 'YJ', 'LastName': 'Cha', 'Affiliation': 'Department of Physical Therapy, College of Health and Medical Science, Daejeon University, Republic of Korea.'}]",Journal of musculoskeletal & neuronal interactions,[] 2350,33657450,Effects of SSRI treatment on GABA and glutamate levels in an associative relearning paradigm.,"Impaired cognitive flexibility represents a widespread symptom in psychiatric disorders, including major depressive disorder (MDD), a disease, characterized by an imbalance of neurotransmitter concentrations. While memory formation is mostly associated with glutamate, also gamma-Aminobutyric acid (GABA) and serotonin show attributions in a complex interplay between neurotransmitter systems. Treatment with selective serotonin reuptake inhibitors (SSRIs) does not solely affect the serotonergic system but shows downstream effects on GABA- and glutamatergic neurotransmission, potentially helping to restore cognitive function via neuroplastic effects. Hence, this study aims to elaborate the effects of associative relearning and SSRI treatment on GABAergic and glutamatergic function within and between five brain regions using magnetic resonance spectroscopy imaging (MRSI). In this study, healthy subjects were randomized into four groups which underwent three weeks of an associative relearning paradigm, with or without emotional connotation, under SSRI (10mg escitalopram) or placebo administration. MRSI measurements, using a spiral-encoded, 3D-GABA-edited MEGA-LASER sequence at 3T, were performed on the first and last day of relearning. Mean GABA+/tCr (GABA+ = GABA + macromolecules; tCr = total creatine) and Glx/tCr (Glx = glutamate + glutamine) ratios were quantified in a ROI-based approach for the hippocampus, insula, putamen, pallidum and thalamus, using LCModel. A total of 66 subjects ((37 female, mean age ± SD = 25.4±4.7) for Glx/tCr and 58 subjects (32 female, mean age ± SD = 25.1±4.7) for GABA+/tCr were included in the final analysis. A significant measurement by region and treatment (SSRI vs placebo) interaction on Glx/tCr ratios was found (p cor =0.017), with post hoc tests confirming differential effects on hippocampus and thalamus (p cor =0.046). Moreover, treatment by time comparison, for each ROI independently, showed a reduction of hippocampal Glx/tCr ratios after SSRI treatment (p uncor =0.033). No significant treatment effects on GABA+/tCr ratios or effects of relearning condition on any neurotransmitter ratio could be found. Here, we showed a significant SSRI- and relearning-driven interaction effect of hippocampal and thalamic Glx/tCr levels, suggesting differential behavior based on different serotonin transporter and receptor densities. Moreover, an indication for Glx/tCr adaptions in the hippocampus after three weeks of SSRI treatment could be revealed. Our findings are in line with animal studies reporting glutamate adaptions in the hippocampus following chronic SSRI intake. Due to the complex interplay of serotonin and hippocampal function, involving multiple serotonin receptor subtypes on glutamatergic cells and GABAergic interneurons, the interpretation of underlying neurobiological actions remains challenging.",2021,No significant treatment effects on GABA+/tCr ratios or effects of relearning condition on any neurotransmitter ratio could be found.,"['healthy subjects', '66 subjects ((37 female, mean age ± SD\u202f=\u202f25.4±4.7) for Glx/tCr and 58 subjects (32 female, mean age ± SD\u202f=\u202f25.1±4.7) for GABA+/tCr were included in the final analysis']","['associative relearning and SSRI treatment', 'SSRI', 'magnetic resonance spectroscopy imaging (MRSI', 'associative relearning paradigm, with or without emotional connotation, under SSRI (10mg escitalopram) or placebo administration', 'selective serotonin reuptake inhibitors (SSRIs']","['\u202fGABA\u202f+\u202fmacromolecules; tCr\u202f=\u202ftotal creatine) and Glx/tCr (Glx\u202f=\u202fglutamate\u202f+\u202fglutamine) ratios', 'hippocampal Glx/tCr ratios', 'GABA+/tCr ratios', 'GABA and glutamate levels', 'Mean GABA+/tCr (GABA', 'Glx/tCr ratios']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0034790', 'cui_str': 'T-cell antigen receptor'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}, {'cui': 'C0034790', 'cui_str': 'T-cell antigen receptor'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",66.0,0.036752,No significant treatment effects on GABA+/tCr ratios or effects of relearning condition on any neurotransmitter ratio could be found.,"[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Spurny', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Vanicek', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Seiger', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Reed', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Klöbl', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Ritter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Unterholzner', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'G M', 'Initials': 'GM', 'LastName': 'Godbersen', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'L R', 'Initials': 'LR', 'LastName': 'Silberbauer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Pacher', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Klug', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Konadu', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Gryglewski', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Trattnig', 'Affiliation': 'Department of Biomedical Imaging and Image-guided Therapy, High Field MR Centre, Medical University of Vienna, Austria; Christian Doppler Laboratory for Clinical Molecular MR Imaging, Vienna, Austria.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Bogner', 'Affiliation': 'Department of Biomedical Imaging and Image-guided Therapy, High Field MR Centre, Medical University of Vienna, Austria.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Lanzenberger', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria. Electronic address: rupert.lanzenberger@meduniwien.ac.at.'}]",NeuroImage,['10.1016/j.neuroimage.2021.117913'] 2351,33647762,Effects of manipulating body temperature on sleep in postmenopausal women.,"STUDY OBJECTIVES A decline in sleep quality, slow wave sleep (SWS) and slow wave activity (SWA) are common in older adults. Prior studies have shown that manipulating body temperature during sleep can increase SWS/SWA. The aim of this study was to determine the effects of manipulation of body temperatures during sleep, using a high heat capacity mattress, on SWS/SWA and heart rate in post-menopausal women. METHODS Twenty-four healthy postmenopausal women between 40 and 75 years of age (mean age 62.4 ± 8.2 years, mean BMI 25.4 ± 3.5 kg/m 2 ) were randomized in a single-blind, counterbalanced, cross-over manner to sleep on either a high heat capacity mattress (HHCM) or a low heat capacity mattress (LHCM) a week apart. Sleep was recorded using polysomnography during an 8-h sleep opportunity. Core and peripheral temperature were recorded using an ingestible capsule and thermochron respectively. RESULTS In comparison to the LHCM, sleep on HHCM exhibited a selective increase in SWS (average increase in Stage N3 of 9.6 min (2.1%), p = 0.04) and in slow oscillatory (SO) activity (0.5-1 Hz) in the first NREM/REM cycle (p = 0.04). In addition, the HHCM induced a greater reduction in core body temperature (p = 0.002). The reduction in core body temperature (first 180 min after lights out) from LHCM to HHCM was associated (r = 0.5, p = 0.012) with the increase in SO activity (SO cycle 1 and 2/cycle 3 and 4). Average heart rate was 1.6 beats/minute lower across the night on the HHCM compared to the LHCM (p = 0.001). CONCLUSIONS The results of this study indicate that manipulation of body temperature during sleep may be a useful approach to enhance SWS sleep in postmenopausal women.",2021,"Average heart rate was 1.6 beats/minute lower across the night on the HHCM compared to the LHCM (p = 0.001). ","['postmenopausal women', 'older adults', 'Twenty-four healthy postmenopausal women between 40 and 75 years of age (mean age 62.4\xa0±\xa08.2 years, mean BMI 25.4\xa0±\xa03.5\xa0kg/m 2 ', 'post-menopausal women']","['counterbalanced, cross-over manner to sleep on either a high heat capacity mattress (HHCM) or a low heat capacity mattress (LHCM', 'HHCM', 'manipulating body temperature']","['sleep quality, slow wave sleep (SWS) and slow wave activity (SWA', 'SWS', 'Sleep', 'core body temperature', 'Average heart rate', 'Core and peripheral temperature', 'SO activity', 'reduction in core body temperature', 'slow oscillatory (SO) activity', 'SWS/SWA and heart rate']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}]","[{'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0024940', 'cui_str': 'Mattress'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0234451', 'cui_str': 'Non-rapid eye movement sleep'}, {'cui': 'C0858603', 'cui_str': 'Wave slowing'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0456240', 'cui_str': 'Core body temperature'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",24.0,0.0301902,"Average heart rate was 1.6 beats/minute lower across the night on the HHCM compared to the LHCM (p = 0.001). ","[{'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Reid', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA. Electronic address: k-reid@northwestern.edu.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Kräuchi', 'Affiliation': 'Psychiatric University Clinics, Basel, Switzerland.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Grimaldi', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Sbarboro', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Hrayr', 'Initials': 'H', 'LastName': 'Attarian', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Roneil', 'Initials': 'R', 'LastName': 'Malkani', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Mason', 'Affiliation': 'Technogel Italia S.r.l. Pozzoleone (VI) Italy.'}, {'ForeName': 'Phyllis C', 'Initials': 'PC', 'LastName': 'Zee', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}]",Sleep medicine,['10.1016/j.sleep.2021.01.064'] 2352,33636453,Impact of subsequent immune checkpoint inhibitor treatment on overall survival with avelumab vs docetaxel in platinum-treated advanced NSCLC: Post hoc analyses from the phase 3 JAVELIN Lung 200 trial.,"OBJECTIVES The JAVELIN Lung 200 phase 3 trial did not meet its primary endpoint of improving overall survival (OS) with avelumab vs docetaxel in patients with platinum-treated PD-L1+ NSCLC. We report post hoc analyses assessing the effects of subsequent immune checkpoint inhibitor (ICI) treatment on OS. MATERIAL AND METHODS Patients with stage IIIB/IV NSCLC progressed following platinum-doublet therapy were randomized to receive avelumab or docetaxel. OS was analyzed in the PD-L1+ population (≥1% of tumor cells) and full analysis set (PD-L1+ or PD-L1-). Effects of subsequent ICI (after permanent discontinuation of study treatment) on OS were analyzed using a preplanned naive sensitivity analysis and post hoc inverse probability of censoring weighting (IPCW) analysis. Subgroups with or without subsequent ICI treatment were analyzed using descriptive statistics. RESULTS In the avelumab and docetaxel arms, a subsequent ICI was received by 16/396 (4.0 %) and 104/396 (26.3 %) after a median of 10.5 months (range, 3.9-20.4) and 5.7 months (range, 0.1-24.4), respectively. Some subgroups showed trends for higher subsequent ICI treatment, including patients with non-squamous NSCLC (avelumab arm, 4.3 % vs docetaxel arm, 32.1 %) or with a baseline ECOG performance status of 0 (6.3 % vs 31.3 %); those enrolled in the early recruitment wave (11.6 % vs 54.3 %), or enrolled in the US/Western Europe (2.8 % vs 45.5 %) or Asia (11.0 % vs 35.4 %); and non-white patients (10.1 % vs 35.0 %). The hazard ratio for OS with avelumab vs docetaxel was lower in the IPCW analysis than in the naive sensitivity analysis (PD-L1+ population: 0.80 [95 % CI, 0.62-1.04] vs 0.86 [95 % CI, 0.68-1.09], respectively). CONCLUSION In the JAVELIN Lung 200 trial, avelumab showed clinical activity as second-line treatment for patients with advanced NSCLC. Post hoc analyses suggest that the primary OS analysis may have been confounded by subsequent ICI use in the docetaxel arm. ClinicalTrials.gov identifier: NCT02395172.",2021,"The hazard ratio for OS with avelumab vs docetaxel was lower in the IPCW analysis than in the naive sensitivity analysis (PD-L1+ population: 0.80 [95 % CI, 0.62-1.04] vs 0.86 [95 % CI, 0.68-1.09], respectively). ","['patients with platinum-treated PD-L1+ NSCLC', 'patients with advanced NSCLC', 'Patients with stage IIIB/IV NSCLC progressed following platinum-doublet therapy', 'platinum-treated advanced NSCLC']","['avelumab and docetaxel', 'avelumab vs docetaxel', 'avelumab or docetaxel', 'subsequent immune checkpoint inhibitor (ICI', 'subsequent ICI']","['overall survival (OS', 'clinical activity', 'hazard ratio for OS', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C4055417', 'cui_str': 'avelumab'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.166791,"The hazard ratio for OS with avelumab vs docetaxel was lower in the IPCW analysis than in the naive sensitivity analysis (PD-L1+ population: 0.80 [95 % CI, 0.62-1.04] vs 0.86 [95 % CI, 0.68-1.09], respectively). ","[{'ForeName': 'Keunchil', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. Electronic address: kpark@skku.edu.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': 'Department of Internal Medicine, Division of Medical Oncology, Cerrahpaşa Medical Faculty, Istanbul University Cerrahpaşa, Istanbul, Turkey. Electronic address: ozguroglu@gmail.com.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Vansteenkiste', 'Affiliation': 'Department of Respiratory Oncology, University Hospital KU Leuven, Leuven, Belgium. Electronic address: johan.vansteenkiste@uzleuven.be.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Spigel', 'Affiliation': 'Sarah Cannon Research Institute, Nashville, TN, USA. Electronic address: David.Spigel@sarahcannon.com.'}, {'ForeName': 'James C-H', 'Initials': 'JC', 'LastName': 'Yang', 'Affiliation': 'Department of Medical Oncology, National Taiwan University Cancer Center, Taipei, Taiwan. Electronic address: chihyang@ntu.edu.tw.'}, {'ForeName': 'Marcis', 'Initials': 'M', 'LastName': 'Bajars', 'Affiliation': 'EMD Serono Research & Development Institute, Inc., Billerica, MA, USA; an affiliate of Merck KGaA, Darmstadt, Germany. Electronic address: marcis.bajars@emdserono.com.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Ruisi', 'Affiliation': 'EMD Serono Research & Development Institute, Inc., Billerica, MA, USA; an affiliate of Merck KGaA, Darmstadt, Germany. Electronic address: mary.ruisi@emdserono.com.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Manitz', 'Affiliation': 'EMD Serono Research & Development Institute, Inc., Billerica, MA, USA; an affiliate of Merck KGaA, Darmstadt, Germany. Electronic address: juliane.manitz@emdserono.com.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Barlesi', 'Affiliation': 'Aix Marseille University, CNRS, INSERM, CRCM, Marseille, France; Gustave Roussy Cancer Campus, Villejuif, France. Electronic address: fabrice.barlesi@gustaveroussy.fr.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2021.01.026'] 2353,33639516,"The effects of reiki on heart rate, blood pressure, body temperature, and stress levels: A pilot randomized, double-blinded, and placebo-controlled study.","Reiki is a biofield energy therapy that focuses on optimizing the body's natural healing abilities by balancing the life force energy or qi/chi. Reiki has been shown to reduce stress, pain levels, help with depression/anxiety, increase relaxation, improve fatigue, and quality of life. In this pilot randomized, double-blinded, and placebo-controlled study, the effects of Reiki on heart rate, diastolic and systolic blood pressure, body temperature, and stress levels were explored in an effort to gain objective outcome measures and to understand the underlying physiological mechanisms of how Reiki may be having these therapeutic effects on subjective measures of stress, pain, relaxation, and depression/anxiety. Forty eight (n = 48) subjects were block randomized into three groups (Reiki treatment, sham treatment, and no treatment). The changes in pre- and post-treatment measurements for each outcome measure was analyzed through analysis of variance (ANOVA) post hoc multiple comparison test, which found no statistically significant difference between any of the groups. The p-value for the comparison of Reiki and sham groups for heart rate was 0.053, which is very close to being significant and so, a definitive conclusion can not be made based on this pilot study alone. A second study with a larger sample size is warranted to investigate this finding further and perhaps with additional outcome measures to look at other possible physiological mechanisms that may underlie the therapeutic effects of Reiki.",2021,"The p-value for the comparison of Reiki and sham groups for heart rate was 0.053, which is very close to being significant and so, a definitive conclusion can not be made based on this pilot study alone.",['Forty eight (n\xa0=\xa048) subjects'],['placebo'],"['heart rate', 'stress, pain levels, help with depression/anxiety, increase relaxation, improve fatigue, and quality of life', 'subjective measures of stress, pain, relaxation, and depression/anxiety', 'heart rate, diastolic and systolic blood pressure, body temperature, and stress levels', 'heart rate, blood pressure, body temperature, and stress levels']","[{'cui': 'C4319608', 'cui_str': '48'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",48.0,0.13131,"The p-value for the comparison of Reiki and sham groups for heart rate was 0.053, which is very close to being significant and so, a definitive conclusion can not be made based on this pilot study alone.","[{'ForeName': 'Namuun', 'Initials': 'N', 'LastName': 'Bat', 'Affiliation': 'Ohio Wesleyan University, Delaware, OH, USA. Electronic address: namuun.bat@bastyr.edu.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101328'] 2354,33666594,Agreement Between the Iron Path App and a Linear Position Transducer for Measuring Average Concentric Velocity and Range of Motion of Barbell Exercises.,"ABSTRACT Kasovic, J, Martin, B, Carzoli, JP, Zourdos, MC, and Fahs, CA. Agreement between the Iron Path app and a linear position transducer for measuring average concentric velocity and range of motion of barbell exercises. J Strength Cond Res 35(2S): S95-S101, 2021-The purpose of this study was to compare average concentric velocity (ACV) and range of motion (ROM) values measured by the Iron Path (IP) app to the previously validated Open Barbell System (OBS) linear position transducer during the front and back squat and conventional and sumo deadlift. Twenty-seven men and women (21 ± 3 years old; 76.7 ± 14.5 kg; 1.72 ± 0.09 m) with squat and deadlift training experience completed a modified one repetition maximum protocol on 4 separate occasions in a randomized order. The IP app and OBS device recorded ACV and ROM during each protocol. The level of statistical significant was set at p ≤ 0.05. Bland-Altman plots showed fairly large limits of agreement for both ACV and ROM. Furthermore, 95% confidence intervals for the intraclass correlation coefficients indicated the agreement in ACV between the devices for each of the 4 lifts to range from 0.648-0.876 to 0.849-0.930 and for agreement in ROM between devices to range from -0.053-0.480 to 0.545-0.770. Compared with the OBS, the IP app recorded significantly (p < 0.05) lower ACV values for the front squat and back squat and greater ROM values for the sumo deadlift. We suggest the IP app should not be used in place of a validated linear position transducer for measuring ACV or ROM for barbell lifts.",2021,"Compared with the OBS, the IP app recorded significantly (p < 0.05) lower ACV values for the front squat and back squat and greater ROM values for the sumo deadlift.",['Twenty-seven men and women (21 ± 3 years old; 76.7 ± 14.5 kg; 1.72 ± 0.09 m) with squat and deadlift training experience completed a'],"['J Strength Cond Res 35(2S', 'modified one repetition maximum protocol']","['ROM values', 'ACV values', 'Average Concentric Velocity and Range of Motion of Barbell Exercises', 'average concentric velocity and range of motion of barbell exercises', 'average concentric velocity (ACV) and range of motion (ROM) values']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517513', 'cui_str': '1.72'}, {'cui': 'C4517419', 'cui_str': '0.09'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0306052,"Compared with the OBS, the IP app recorded significantly (p < 0.05) lower ACV values for the front squat and back squat and greater ROM values for the sumo deadlift.","[{'ForeName': 'Jovana', 'Initials': 'J', 'LastName': 'Kasovic', 'Affiliation': 'Department of Exercise Science, Lindenwood University Belleville, Belleville Illinois.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Martin', 'Affiliation': 'Department of Exercise Science, Lindenwood University Belleville, Belleville Illinois.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Carzoli', 'Affiliation': 'Department of Integrative Physiology, University of Colorado, Boulder, Colorado.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Zourdos', 'Affiliation': 'Department of Exercise Science and Health Promotion, Muscle Physiology Laboratory, Florida Atlantic University, Boca Raton, Florida; and.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Fahs', 'Affiliation': 'College of Health Sciences, Logan University, Chesterfield, Missouri.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003574'] 2355,33662389,Six vs 12 Sessions of Gut-focused Hypnotherapy for Irritable Bowel Syndrome: A Randomized Trial.,,2021,,['irritable bowel syndrome'],['gut-focused hypnotherapy'],[],"[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}]","[{'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}]",[],,0.0306534,,"[{'ForeName': 'Syed S', 'Initials': 'SS', 'LastName': 'Hasan', 'Affiliation': 'Neurogastroenterology Unit, Wythenshawe Hospital, Manchester University NHS Foundation Trust, Manchester, United Kingdom; Division of Diabetes, Endocrinology and Gastroenterology, School of Medical Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Whorwell', 'Affiliation': 'Neurogastroenterology Unit, Wythenshawe Hospital, Manchester University NHS Foundation Trust, Manchester, United Kingdom; Division of Diabetes, Endocrinology and Gastroenterology, School of Medical Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Vivien', 'Initials': 'V', 'LastName': 'Miller', 'Affiliation': 'Neurogastroenterology Unit, Wythenshawe Hospital, Manchester University NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Morris', 'Affiliation': 'Department of Medical Statistics, Manchester University NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Dipesh H', 'Initials': 'DH', 'LastName': 'Vasant', 'Affiliation': 'Neurogastroenterology Unit, Wythenshawe Hospital, Manchester University NHS Foundation Trust, Manchester, United Kingdom; Division of Diabetes, Endocrinology and Gastroenterology, School of Medical Sciences, University of Manchester, Manchester, United Kingdom. Electronic address: dipesh.vasant@manchester.ac.uk.'}]",Gastroenterology,['10.1053/j.gastro.2021.02.058'] 2356,33668789,Effectiveness of Smartwatch Guidance for High-Quality Infant Cardiopulmonary Resuscitation: A Simulation Study.,"Background and objectives: As in adults, the survival rates and neurological outcomes after infant Cardiopulmonary resuscitation (CPR) are closely related to the quality of resuscitation. This study aimed to demonstrate that using a smartwatch as a haptic feedback device increases the quality of infant CPR performed by medical professionals. Materials and methods: We designed a prospective, randomized, case-crossover simulation study. The participants (n = 36) were randomly allocated to two groups: control first group and smartwatch first group. Each CPR session consisted of 2 min of chest compressions (CCs) using the two-finger technique (TFT), 2 min of rest, and 2 min of CCs using the two-thumb encircling hands technique (TTHT). Results: The primary outcome was the variation in the ""proportion of optimal chest compression duration"" and ""compression rate"" between the smartwatch-assisted and non-smartwatch-assisted groups. The secondary outcome was the variation in the ""compression depth"" between two groups. The proportion of optimal CC duration was significantly higher in the smartwatch-assisted group than in the non-smartwatch-assisted group. The absolute difference from 220 was much smaller in the smartwatch-assisted group (218.02) than in the non-smartwatch-assisted group (226.59) ( p -Value = 0.018). Conclusion: This study demonstrated the haptic feedback system using a smartwatch improves the quality of infant CPR by maintaining proper speed and depth regardless of the compression method used.",2021,The proportion of optimal CC duration was significantly higher in the smartwatch-assisted group than in the non-smartwatch-assisted group.,"['High-Quality Infant Cardiopulmonary Resuscitation', 'participants (n = 36']","['Smartwatch Guidance', 'chest compressions (CCs) using the two-finger technique (TFT), 2 min of rest, and 2 min of CCs using the two-thumb encircling hands technique (TTHT', 'control first group and smartwatch first group', 'haptic feedback device']","['proportion of optimal CC duration', 'compression depth', 'survival rates and neurological outcomes', 'quality of infant CPR', 'variation in the ""proportion of optimal chest compression duration"" and ""compression rate"" between the smartwatch-assisted and non-smartwatch-assisted groups']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]","[{'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0040067', 'cui_str': 'Thumb structure'}, {'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C0456980', 'cui_str': 'Hand endodontic technique'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",36.0,0.0267201,The proportion of optimal CC duration was significantly higher in the smartwatch-assisted group than in the non-smartwatch-assisted group.,"[{'ForeName': 'Seong A', 'Initials': 'SA', 'LastName': 'Jeon', 'Affiliation': 'Department of Emergency Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Hansol', 'Initials': 'H', 'LastName': 'Chang', 'Affiliation': 'Department of Emergency Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Sun Young', 'Initials': 'SY', 'LastName': 'Yoon', 'Affiliation': 'Department of Digital Health, Samsung Advanced Institute for Health Sciences and Technology, Sungkyunkwan University, Seoul 06355, Korea.'}, {'ForeName': 'Nayeong', 'Initials': 'N', 'LastName': 'Hwang', 'Affiliation': 'Biostatistics and Clinical Epidemiology Center, Samsung Medical Center, Seoul 06351, Korea.'}, {'ForeName': 'Kyunga', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Biostatistics and Clinical Epidemiology Center, Samsung Medical Center, Seoul 06351, Korea.'}, {'ForeName': 'Hee', 'Initials': 'H', 'LastName': 'Yoon', 'Affiliation': 'Department of Emergency Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Sung Yeon', 'Initials': 'SY', 'LastName': 'Hwang', 'Affiliation': 'Department of Emergency Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Tae Gun', 'Initials': 'TG', 'LastName': 'Shin', 'Affiliation': 'Department of Emergency Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Won Chul', 'Initials': 'WC', 'LastName': 'Cha', 'Affiliation': 'Department of Emergency Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Taerim', 'Initials': 'T', 'LastName': 'Kim', 'Affiliation': 'Department of Emergency Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina57030193'] 2357,33668740,Higher Impulse Electromyostimulation Contributes to Psychological Satisfaction and Physical Development in Healthy Men.,"Background and Objectives : This study investigated the various impulse effects of whole-body electromyostimulation (WB-EMS) on psychophysiological responses and adaptations. Materials and Methods : The participants included fifty-four men between 20 and 27 years of age who practiced isometric exercises for 20 min, three days a week, for 12 weeks while wearing WB-EMS suits, which enabled the simultaneous activation of eight muscle groups with three types of impulse intensities. Participants were allocated to one of four groups: control group (CON), low-impulse-intensity group (LIG), mid-impulse-intensity group (MIG), and high-impulse-intensity group (HIG). Psychophysiological conditions were measured at week 0, week 4, week 8, and week 12. Results : Compared with the CON, (1) three psychological conditions in LIG, MIG, and HIG showed positive tendencies every four weeks, and the analysis of covariance (ANCOVA) test revealed that body image ( p = 0.004), body shape ( p = 0.007), and self-esteem ( p = 0.001) were significantly different among the groups. (2) Body weight, fat mass, body mass index, and percent fat in the CON showed decreasing tendencies, whereas those in LIG, MIG, and HIG showed a noticeable decrease, which revealed that there were significant differences among the groups. Specifically, a higher impulse intensity resulted in a greater increase in muscle mass. (3) Although there was no interaction effect in the abdominal visceral fat area, there were significant interactions in the abdominal subcutaneous fat (ASF) and total fat (ATF) areas. Both the ASF and ATF in the CON showed decreasing tendencies, whereas those in other groups showed a noticeable decrease. The ANCOVA revealed that the ASF ( p = 0.002) and ATF ( p = 0.001) were significantly different among the groups. In particular, the higher the impulse intensity, the greater the decrease in abdominal fat. Conclusions : This study confirmed that high-impulse-intensity EMS can improve psychophysiological conditions. In other words, healthy young adults felt that the extent to which their body image, body shape, and self-esteem improved depended on how intense their EMS impulse intensities were. The results also showed that higher levels of impulse intensity led to improved physical conditions.",2021,The ANCOVA revealed that the ASF ( p = 0.002) and ATF ( p = 0.001) were significantly different among the groups.,"['healthy young adults', 'Healthy Men', 'participants included fifty-four men between 20 and 27 years of age who']","['whole-body electromyostimulation (WB-EMS', 'practiced isometric exercises', 'control group (CON), low-impulse-intensity group (LIG), mid-impulse-intensity group (MIG), and high-impulse-intensity group (HIG', 'Materials and Methods ']","['2) Body weight, fat mass, body mass index', 'abdominal fat', 'Psychophysiological conditions', 'muscle mass', 'self-esteem', 'psychophysiological responses and adaptations', 'abdominal subcutaneous fat (ASF) and total fat (ATF) areas', 'ATF', 'body shape']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1563742', 'cui_str': 'Fat, Abdominal'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C1563741', 'cui_str': 'Fat, Abdominal Subcutaneous'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1148798', 'cui_str': 'ATF Transcription Factors'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}]",54.0,0.016972,The ANCOVA revealed that the ASF ( p = 0.002) and ATF ( p = 0.001) were significantly different among the groups.,"[{'ForeName': 'Kangho', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Research Institute of Sports and Industry Science, Hanseo University, Seosan 31962, Korea.'}, {'ForeName': 'Denny', 'Initials': 'D', 'LastName': 'Eun', 'Affiliation': 'Research Institute of Sports and Industry Science, Hanseo University, Seosan 31962, Korea.'}, {'ForeName': 'Yong-Seok', 'Initials': 'YS', 'LastName': 'Jee', 'Affiliation': 'Research Institute of Sports and Industry Science, Hanseo University, Seosan 31962, Korea.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina57030191'] 2358,33667155,The effect of nursing interventions on immigrant women living in Northern Cyprus on their breastfeeding self-efficacy and success: a randomized controlled trial.,"This study was conducted as a randomized controlled study to determine the effect of nursing interventions, which were based on Dennis's Breastfeeding Self-Efficacy Theory and Pender's Health Promotion Model during home visits, on the breastfeeding self-efficacy and success of immigrant women living in Northern Cyprus. The sample consisted of N   =   60 primipar immigrant women (experimental group n   =   30, control group n   =   30) who attended a primary healthcare center in Northern Cyprus between April 2019 and January 2020. The data were collected from the participants using a Socio-Demographic Questionnaire, the Breastfeeding Self-Efficacy Scale and the LATCH Breastfeeding Assessment Tool. Before the study, no statistically significant difference was found between two groups in terms of breastfeeding self-efficacy and the LATCH assessment ( p   >   0.05). After the intervention, the mean score for the Breastfeeding Self-Efficacy Scale increased by 9.73 in the experimental group and 3.16 in the control group compared to before the study, and the effect size was found to be 6.57. The score for the LATCH assessment increased by 3.2 in the experimental group and 1.44 in the control group, and the effect size was found to be 1.76 ( p   <   0.05).",2021,"After the intervention, the mean score for the Breastfeeding Self-Efficacy Scale increased by 9.73 in the experimental group and 3.16 in the control group compared to before the study, and the effect size was found to be 6.57.","['immigrant women living in Northern Cyprus on their breastfeeding self-efficacy and success', 'in Northern Cyprus between April 2019 and January 2020', 'immigrant women living in Northern Cyprus']","['N \u2009 = \u2009 60 primipar immigrant women (experimental group n \u2009 = \u2009 30, control group n \u2009 = \u2009 30) who attended a primary healthcare center', 'nursing interventions']","['effect size', 'LATCH assessment', 'mean score for the Breastfeeding Self-Efficacy Scale', 'Socio-Demographic Questionnaire, the Breastfeeding Self-Efficacy Scale and the LATCH Breastfeeding Assessment Tool', 'breastfeeding self-efficacy and the LATCH assessment']","[{'cui': 'C0282163', 'cui_str': 'Immigrant'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0010622', 'cui_str': 'Cyprus'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0282163', 'cui_str': 'Immigrant'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0441848', 'cui_str': 'Group N'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4040399', 'cui_str': 'Assessment of breastfeeding'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]",,0.0272269,"After the intervention, the mean score for the Breastfeeding Self-Efficacy Scale increased by 9.73 in the experimental group and 3.16 in the control group compared to before the study, and the effect size was found to be 6.57.","[{'ForeName': 'Dilay', 'Initials': 'D', 'LastName': 'Necipoğlu', 'Affiliation': 'Faculty of Nursing, Near East University, Nicosia, Cyprus.'}, {'ForeName': 'Hatice', 'Initials': 'H', 'LastName': 'Bebiş', 'Affiliation': 'Faculty of Nursing, Near East University, Nicosia, Cyprus.'}, {'ForeName': 'Ümit', 'Initials': 'Ü', 'LastName': 'Seviğ', 'Affiliation': 'Faculty of Nursing, Near East University, Nicosia, Cyprus.'}]",Health care for women international,['10.1080/07399332.2021.1883023'] 2359,33675156,A pilot study of oxidative pathways in MS fatigue: randomized trial of N-acetyl cysteine.,"OBJECTIVE To assess feasibility, tolerability, and safety of N-acetyl cysteine (NAC) for fatigue in progressive MS. Secondary objectives evaluated changes in fatigue and oxidative pathway biomarkers on NAC versus placebo. METHODS Individuals with progressive MS with Modified Fatigue Impact Scale (MFIS) > t38 were randomized 2:1 to NAC 1250mg TID or placebo for 4 weeks. The primary outcome was tolerability and safety. The secondary outcome to evaluate efficacy was MFIS change from baseline to week 4 between groups. Exploratory biomarker outcomes included change in blood GSH/GSSG ratio (reduced-to-oxidized glutathione (GSH)) and in vivo relative GSH using 7T MR spectroscopy (MRS) between groups. Fisher exact test was used for categorical and rank sum for continuous outcomes. RESULTS Fifiteen were randomized (10 NAC, 5 placebo; mean age 56.1 years, 80% female, median EDSS 6.0). At least one adverse event (AE) occurred in 60% on NAC versus 80% on placebo (p = 0.75). There were two AEs attributed to NAC in one patient (abdominal pain and constipation), with 94% adherence to NAC. MFIS decreased in both groups at week 4, with the mean improvement of 11-points on NAC versus 18-points on placebo (p = 0.33). GSH/GSSG ratio decreased on placebo (-0.6) and NAC (-0.1) (p = 0.18). Change in GSH levels to total creatine in anterior and posterior cingulate cortex, insula, caudate, putamen, and thalamus did not differ between groups. INTERPRETATION NAC was well-tolerated in progressive MS, although reduction in fatigue on NAC was similar to placebo. Antioxidant blood and MRS biomarkers were not significantly altered by NAC, which could be due to dose, route of administration, time of sample collection, short half-life, or lack of effect. REGISTERED: clinicaltrials.gov NCT02804594.",2021,GSH/GSSG ratio decreased on placebo (-0.6) and NAC (-0.1) (p = 0.18).,"['Individuals with progressive MS with Modified Fatigue Impact Scale (MFIS) ', 'MS fatigue', 'Fifiteen were randomized (10 NAC, 5 placebo; mean age 56.1\xa0years, 80% female, median EDSS 6.0']","['placebo', 'NAC', 'NAC 1250mg TID or placebo', 'N-acetyl cysteine (NAC', 'N-acetyl cysteine']","['feasibility, tolerability, and safety', 'fatigue and oxidative pathway biomarkers', 'MFIS', 'blood GSH/GSSG ratio (reduced-to-oxidized glutathione (GSH', 'GSH/GSSG ratio', 'tolerability and safety', 'Antioxidant blood and MRS biomarkers', 'Change in GSH levels to total creatine in anterior and posterior cingulate cortex, insula, caudate, putamen, and thalamus', 'adverse event (AE']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2733557', 'cui_str': 'Fatigue impact scale'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C4517554', 'cui_str': '1250'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2733557', 'cui_str': 'Fatigue impact scale'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0061516', 'cui_str': 'Glutathione Disulfide'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate Gyri'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.538443,GSH/GSSG ratio decreased on placebo (-0.6) and NAC (-0.1) (p = 0.18).,"[{'ForeName': 'Kristen M', 'Initials': 'KM', 'LastName': 'Krysko', 'Affiliation': 'UCSF Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Bischof', 'Affiliation': 'UCSF Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Bardia', 'Initials': 'B', 'LastName': 'Nourbakhsh', 'Affiliation': 'Department of Neurology, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Roland G', 'Initials': 'RG', 'LastName': 'Henry', 'Affiliation': 'UCSF Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Revirajan', 'Affiliation': 'UCSF Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Manguinao', 'Affiliation': 'UCSF Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Khang', 'Initials': 'K', 'LastName': 'Nguyen', 'Affiliation': 'UCSF Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Akula', 'Affiliation': 'UCSF Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Radiology and Biomedical Imaging, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Waubant', 'Affiliation': 'UCSF Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, California, USA.'}]",Annals of clinical and translational neurology,['10.1002/acn3.51325'] 2360,33671031,Extended fMRI-Guided Anodal and Cathodal Transcranial Direct Current Stimulation Targeting Perilesional Areas in Post-Stroke Aphasia: A Pilot Randomized Clinical Trial.,"Transcranial direct current stimulation (tDCS) may enhance speech and language treatment (SLT) for stroke survivors with aphasia; however, to date, there is no standard protocol for the application of tDCS in post-stroke aphasia. We explored the safety and efficacy of fMRI-guided tDCS on functional language and cortical activity when delivered to the lesioned left hemisphere concurrently with SLT across an extended, six-week treatment period. Twelve persons with chronic, nonfluent aphasia following a single left-hemisphere stroke participated in the three-arm (anodal vs. cathodal vs. sham) single-blind, parallel, pilot trial. No serious adverse events occurred during 30 treatment sessions or in the following six weeks. All groups demonstrated functional language gains following intensive treatment; however, active tDCS resulted in greater gains in standardized, probe, and caregiver-reported measures of functional language than sham. Evidence declaring one polarity as superior for inducing language recovery was mixed. However, cathodal stimulation to the lesioned left hemisphere, expected to have a down-regulating effect, resulted in increased areas of cortical activation across both hemispheres, and specifically perilesionally. Generalization of these preliminary findings is limited; however, results are nevertheless compelling that tDCS combined with SLT can be safely applied across extended durations, with the potential to enhance functional language and cortical activation for persons with aphasia.",2021,"All groups demonstrated functional language gains following intensive treatment; however, active tDCS resulted in greater gains in standardized, probe, and caregiver-reported measures of functional language than sham.","['stroke survivors with aphasia', 'Post-Stroke Aphasia', 'persons with aphasia', 'Twelve persons with chronic, nonfluent aphasia following a single left-hemisphere stroke participated in the three']","['fMRI-guided tDCS', 'SLT', 'Extended fMRI-Guided Anodal and Cathodal Transcranial Direct Current Stimulation', 'Transcranial direct current stimulation (tDCS', 'arm (anodal vs. cathodal vs. sham) single-blind']","['serious adverse events', 'functional language and cortical activity', 'functional language gains', 'cortical activation', 'greater gains in standardized, probe, and caregiver-reported measures of functional language']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0003550', 'cui_str': 'Motor aphasia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0228176', 'cui_str': 'Left cerebral hemisphere structure'}]","[{'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0242570', 'cui_str': 'Single-Masked Study'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",12.0,0.136253,"All groups demonstrated functional language gains following intensive treatment; however, active tDCS resulted in greater gains in standardized, probe, and caregiver-reported measures of functional language than sham.","[{'ForeName': 'Leora R', 'Initials': 'LR', 'LastName': 'Cherney', 'Affiliation': 'Think + Speak Lab, Shirley Ryan AbilityLab, Chicago, IL 60611, USA.'}, {'ForeName': 'Edna M', 'Initials': 'EM', 'LastName': 'Babbitt', 'Affiliation': 'Think + Speak Lab, Shirley Ryan AbilityLab, Chicago, IL 60611, USA.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Feinberg School of Medicine, Northwestern University, Chicago, IL 60611, USA.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Pitts', 'Affiliation': 'Think + Speak Lab, Shirley Ryan AbilityLab, Chicago, IL 60611, USA.'}]",Brain sciences,['10.3390/brainsci11030306'] 2361,33670999,Coconut Oil Supplementation Does Not Affect Blood Pressure Variability and Oxidative Stress: A Placebo-Controlled Clinical Study in Stage-1 Hypertensive Patients.,"Exploring an alternative to improve the clinical management of hypertension, we tested the hypothesis that food supplementation with coconut oil (EVCO), alone or combined with aerobic exercise training, could exert an antihypertensive effect (primary outcome) in patients with stage 1 hypertension. Forty-five hypertensive volunteers of both genders participated in a placebo-controlled clinical trial. The volunteers were submitted to 24-hour ambulatory blood pressure monitoring, analysis of blood pressure variability (BPV), measurement of serum malondialdehyde (MDA) and nutritional assessment. Results indicate that EVCO consumption had no adverse effects. The supplementation did not increase the caloric intake compared with placebo, and the dietary constituents were similar between groups, except for the saturated fats, especially lauric acid. The analysis of blood pressure indicated absence of antihypertensive effect of EVCO alone or combined with physical training. Furthermore, no effects on blood pressure variability and oxidative stress were observed in the supplemented hypertensive patients. Thus, despite the results observed in pre-clinical studies, the current clinical study did not provide evidence to support the use of coconut oil as an adjuvant in the management of hypertension in humans.",2021,"The supplementation did not increase the caloric intake compared with placebo, and the dietary constituents were similar between groups, except for the saturated fats, especially lauric acid.","['Forty-five hypertensive volunteers of both genders participated in a', 'Stage-1 Hypertensive Patients', 'supplemented hypertensive patients', 'hypertension in humans', 'patients with stage 1 hypertension']","['Coconut Oil Supplementation', 'placebo', 'EVCO alone or combined with physical training', 'coconut oil', 'Placebo', 'coconut oil (EVCO), alone or combined with aerobic exercise training']","['24-hour ambulatory blood pressure monitoring, analysis of blood pressure variability (BPV), measurement of serum malondialdehyde (MDA) and nutritional assessment', 'blood pressure variability and oxidative stress', 'adverse effects', 'Blood Pressure Variability and Oxidative Stress', 'caloric intake']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0056060', 'cui_str': 'Coconut Oil'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0028708', 'cui_str': 'Assessment of nutritional status'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",45.0,0.101645,"The supplementation did not increase the caloric intake compared with placebo, and the dietary constituents were similar between groups, except for the saturated fats, especially lauric acid.","[{'ForeName': 'Francisco A O', 'Initials': 'FAO', 'LastName': 'Júnior', 'Affiliation': 'Health Sciences Center, Department of Physiology and Pathology, Federal University of Paraiba, Joao Pessoa 58051-900, Brazil.'}, {'ForeName': 'Clara R', 'Initials': 'CR', 'LastName': 'Ruiz', 'Affiliation': 'Biotechnology Center, Federal University of Paraiba, Joao Pessoa 58051-900, Brazil.'}, {'ForeName': 'Yohanna', 'Initials': 'Y', 'LastName': 'de Oliveira', 'Affiliation': 'Health Sciences Center, Department of Nutrition, Federal University of Paraiba,Joao Pessoa 58051-900, Brazil.'}, {'ForeName': 'Marco A V', 'Initials': 'MAV', 'LastName': 'Barros', 'Affiliation': 'Medical Sciences Center, Federal University of Paraiba, Joao Pessoa 58051-900, Brazil.'}, {'ForeName': 'Alexandre S', 'Initials': 'AS', 'LastName': 'Silva', 'Affiliation': 'Health Sciences Center, Department of Physical Education, Federal University of Paraiba, Joao Pessoa 58051-900, Brazil.'}, {'ForeName': 'Maria S B', 'Initials': 'MSB', 'LastName': 'Santos', 'Affiliation': 'Health Sciences Center, Department of Physical Education, Federal University of Paraiba, Joao Pessoa 58051-900, Brazil.'}, {'ForeName': 'Vinícius J B', 'Initials': 'VJB', 'LastName': 'Martins', 'Affiliation': 'Health Sciences Center, Department of Physiology and Pathology, Federal University of Paraiba, Joao Pessoa 58051-900, Brazil.'}, {'ForeName': 'Camille M', 'Initials': 'CM', 'LastName': 'Balarini', 'Affiliation': 'Health Sciences Center, Department of Physiology and Pathology, Federal University of Paraiba, Joao Pessoa 58051-900, Brazil.'}, {'ForeName': 'Valdir A', 'Initials': 'VA', 'LastName': 'Braga', 'Affiliation': 'Biotechnology Center, Federal University of Paraiba, Joao Pessoa 58051-900, Brazil.'}]",Nutrients,['10.3390/nu13030798'] 2362,33647588,How adolescents' working memory abilities relate to their alcohol craving in real-life contexts depends on biological sex.,"AIM We sought to elucidate whether stress, peers, and in vivo (i.e., direct) alcohol cues elicit alcohol craving in daily life among adolescents and to test whether individual variation in working memory function and biological sex alters these associations. METHODS We leveraged ecological momentary assessment (EMA) to examine momentary associations between stress, peers, and direct alcohol cues with craving, assessed as ""urge to drink alcohol,"" among 86 male (51.2 %) and female (48.8 %) frequent drinkers (i.e., two or more drinking days per week). Participants were ages 14-24 years (M = 20.7 years, SD = 2.1). Participants completed EMA throughout the day for about one week prior to randomization to a treatment condition for an AUD clinical trial. Pre-registered, secondary analyses focused on craving for assessments when adolescents were not drinking, and assessments occurring after drinking on drinking days were removed. Working memory performance was assessed in the laboratory via the Memory for Words subtest of the Woodcock-Johnson III Tests of Cognitive Abilities. RESULTS Craving was heightened at more stressful moments and when adolescents were with their peers and in the presence of direct alcohol cues. Working memory function was not related to craving but altered the relation of momentary stress, peers, and cues with craving once biological sex-related differences were considered. Females generally had lower craving than males, but working memory function served to buffer against stress-induced craving for males. CONCLUSIONS Higher working memory function buffered the in-the-moment relation of stress with alcohol craving for males but not females.",2021,"Females generally had lower craving than males, but working memory function served to buffer against stress-induced craving for males. ","['Participants were ages 14-24 years (M = 20.7 years, SD = 2.1', '86 male (51.2 %) and female (48.8 %) frequent drinkers (i.e., two or more drinking days per week']",[],['Working memory performance'],"[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]",[],"[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",86.0,0.0315985,"Females generally had lower craving than males, but working memory function served to buffer against stress-induced craving for males. ","[{'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Treloar Padovano', 'Affiliation': 'Department of Psychiatry and Human Behavior, Department of Behavioral and Social Sciences, Center for Alcohol and Addiction Studies, Brown University, Box G-S121-4, Providence, RI, 02912, United States. Electronic address: hayley_treloar@brown.edu.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Miranda', 'Affiliation': 'Department of Psychiatry and Human Behavior, Department of Behavioral and Social Sciences, Center for Alcohol and Addiction Studies, Brown University, Box G-S121-4, Providence, RI, 02912, United States. Electronic address: robert_miranda_jr@brown.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.108642'] 2363,33639484,Acoustic enhancement of slow wave sleep on consecutive nights improves alertness and attention in chronically short sleepers.,"INTRODUCTION Chronic sleep restriction has been linked to occupational errors and motor vehicle crashes. Enhancing slow wave sleep may alleviate some of the cognitive deficits associated with chronic sleep restriction. However, the extent to which acoustic stimulation of slow wave activity (SWA) may improve alertness and attention is not well established, particularly with respect to consecutive nights of exposure. METHODS Twenty-five healthy adults (32.9 ± 8.2 years; 16 female) who self-restricted their sleep during workdays participated in a randomized, double-blind, cross-over study. Participants wore an automated acoustic stimulation device for two consecutive nights. Acoustic tones (50 ms long) were delivered on the up-phase of the slow wave first and then at constant 1-s inter-tone-intervals once N3 was identified (STIM), until an arousal or shift to another sleep stage occurred, or at inaudible decibels during equivalent stimulation periods (SHAM). Subjective alertness/fatigue (KSS, Samn-Perelli) was assessed across both days, and objective measures of alertness (MSLT) and attention (PVT) were assessed after two nights of stimulation. RESULTS After one night of acoustic stimulation, increased slow wave energy was observed in 68% of participants, with an average significant increase of 17.7% (p = 0.01), while Night 2 was associated with a 22.2% increase in SWA (p = 0.08). SWE was highly stable across the two nights of STIM (ICC 0.93, p < 0.001), and around half (56%) of participants were consistently classified as responders (11/25) or non-responders (3/25). Daytime testing showed that participants felt more alert and awake following each night of acoustic stimulation (p < 0.05), with improved objective attention across the day following two nights of acoustic stimulation. DISCUSSION Consecutive nights of acoustic stimulation enhanced SWA on both nights, and improved next day alertness and attention. Given large individual differences, we highlight the need to examine both the long-term effects of stimulation, and to identify inter-individual differences in acoustic stimulation response. Our findings suggest that the use of an acoustic device to enhance slow wave sleep may alleviate some of the deficits in alertness and attention typically associated with sleep restriction.",2021,"Daytime testing showed that participants felt more alert and awake following each night of acoustic stimulation (p < 0.05), with improved objective attention across the day following two nights of acoustic stimulation. ","['Twenty-five healthy adults (32.9\xa0±\xa08.2 years; 16 female) who self-restricted their sleep during workdays participated', 'chronically short sleepers']",['automated acoustic stimulation device'],"['Acoustic tones', 'objective attention', 'SWA', 'Daytime testing', 'Subjective alertness/fatigue (KSS, Samn-Perelli', 'SWE', 'objective measures of alertness (MSLT) and attention (PVT', 'slow wave energy']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0751509', 'cui_str': 'Short-sleeper'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0001164', 'cui_str': 'Stimulation, Acoustic'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0858603', 'cui_str': 'Wave slowing'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0022541', 'cui_str': 'Kearns-Sayre syndrome'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",25.0,0.0783764,"Daytime testing showed that participants felt more alert and awake following each night of acoustic stimulation (p < 0.05), with improved objective attention across the day following two nights of acoustic stimulation. ","[{'ForeName': 'Charmaine', 'Initials': 'C', 'LastName': 'Diep', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, 3800, Clayton, Australia; Cooperative Research Centre for Alertness, Safety and Productivity, 3800, Australia.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Garcia-Molina', 'Affiliation': 'Sleep and Respiratory Care, Philips, Pittsburgh, PA, USA; Department of Psychiatry, University of Wisconsin-Madison, WI, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Jasko', 'Affiliation': 'Sleep and Respiratory Care, Philips, Pittsburgh, PA, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Manousakis', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, 3800, Clayton, Australia.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Ostrowski', 'Affiliation': 'Sleep and Respiratory Care, Philips, Pittsburgh, PA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'White', 'Affiliation': 'Sleep and Respiratory Care, Philips, Pittsburgh, PA, USA.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Anderson', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, 3800, Clayton, Australia; Cooperative Research Centre for Alertness, Safety and Productivity, 3800, Australia. Electronic address: clare.anderson@monash.edu.'}]",Sleep medicine,['10.1016/j.sleep.2021.01.044'] 2364,33656233,Re: Vaginal Er:YAG LASER application in the menopausal ewe model: a randomised estrogen and sham-controlled trial.,,2021,,"['Re', 'menopausal ewe model']",['Vaginal Er:YAG LASER application'],[],"[{'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0337831', 'cui_str': 'Ewe'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0457903', 'cui_str': 'Erbium:YAG laser device'}, {'cui': 'C0185125', 'cui_str': 'Application'}]",[],,0.1796,,"[{'ForeName': 'C T', 'Initials': 'CT', 'LastName': 'Erel', 'Affiliation': 'Department of Obstetrics and Gynaecology, Cerrahpasa Faculty of Medicine, Istanbul University-Cerrahpaşa, Istanbul, Turkey.'}, {'ForeName': 'I B', 'Initials': 'IB', 'LastName': 'Ozcivit', 'Affiliation': 'Department of Obstetrics and Gynaecology, Cerrahpasa Faculty of Medicine, Istanbul University-Cerrahpaşa, Istanbul, Turkey.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16651'] 2365,33661508,"Spesolimab, an Anti-Interleukin-36 Receptor Antibody, in Patients with Palmoplantar Pustulosis: Results of a Phase IIa, Multicenter, Double-Blind, Randomized, Placebo-Controlled Pilot Study.","INTRODUCTION Palmoplantar pustulosis (PPP) is a chronic, inflammatory skin disease, with high disease burden, that is often refractory to treatment. There is a high unmet clinical need for the treatment of patients with PPP. The objectives of this study were to evaluate the safety and efficacy of spesolimab, a novel anti-interleukin-36 receptor antibody, in patients with PPP. METHODS This was a phase IIa, multicenter, double-blind, randomized, placebo-controlled pilot study comparing 900 mg spesolimab (n = 19), 300 mg spesolimab (n = 19), and placebo (n = 21) administered intravenously every 4 weeks until week 12 in patients with PPP. The primary efficacy endpoint was the achievement of Palmoplantar Pustulosis Area and Severity Index 50 (PPP ASI50) at week 16, defined as achieving an ≥ 50% decrease from baseline PPP ASI. RESULTS At week 16, 31.6% of patients in both spesolimab dose groups achieved PPP ASI50 versus 23.8% receiving placebo (risk difference 0.078; 95% confidence interval -0.190, 0.338). Thus, the primary endpoint was not met. Spesolimab was well tolerated with no clinically relevant treatment-emergent safety signals observed. CONCLUSIONS PPP severity declined over time in all treatment groups after the start of treatment, with a faster decline in the spesolimab arms than in the placebo arm, indicating a potential treatment effect for spesolimab. Limitations to the study included a small sample size and lower overall disease severity than expected at baseline. It is possible that the primary efficacy endpoint may have coincided with natural disease resolution in some patients. Further effects of the efficacy of spesolimab in PPP are being explored in a phase IIb trial.",2021,"Spesolimab was well tolerated with no clinically relevant treatment-emergent safety signals observed. ","['patients with PPP', 'Patients with Palmoplantar Pustulosis']","['Placebo', 'placebo', 'spesolimab']","['achievement of Palmoplantar Pustulosis Area and Severity Index 50 (PPP ASI50', 'PPP ASI50', 'safety and efficacy', 'PPP severity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031106', 'cui_str': 'Aggressive periodontitis'}, {'cui': 'C0030246', 'cui_str': 'Pustular psoriasis of palms and soles'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0030246', 'cui_str': 'Pustular psoriasis of palms and soles'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031106', 'cui_str': 'Aggressive periodontitis'}]",,0.569467,"Spesolimab was well tolerated with no clinically relevant treatment-emergent safety signals observed. ","[{'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Mrowietz', 'Affiliation': 'Psoriasis-Center at the Department of Dermatology, University Medical Center, Schleswig-Holstein, Campus Kiel, Kiel, Germany. umrowietz@dermatology.uni-kiel.de.'}, {'ForeName': 'A David', 'Initials': 'AD', 'LastName': 'Burden', 'Affiliation': 'Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Pinter', 'Affiliation': 'Department of Dermatology, Venereology and Allergology, University Clinic Frankfurt Am Main, Frankfurt am Main, Germany.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Center of Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Schäkel', 'Affiliation': 'Department of Dermatology, Universitätsklinikum Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Baum', 'Affiliation': 'Boehringer Ingelheim International GmbH, Biberach, Germany.'}, {'ForeName': 'Yakov', 'Initials': 'Y', 'LastName': 'Datsenko', 'Affiliation': 'Boehringer Ingelheim International GmbH, Biberach, Germany.'}, {'ForeName': 'Hongjie', 'Initials': 'H', 'LastName': 'Deng', 'Affiliation': 'Boehringer Ingelheim (China) Investment Co. Ltd, Shanghai, China.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Padula', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Thoma', 'Affiliation': 'Boehringer Ingelheim International GmbH, Biberach, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bissonnette', 'Affiliation': 'Innovaderm Research Inc., Montreal, Quebec, Canada.'}]",Dermatology and therapy,['10.1007/s13555-021-00504-0'] 2366,33660198,Oral Semaglutide Reduces HbA 1c and Body Weight in Patients with Type 2 Diabetes Regardless of Background Glucose-Lowering Medication: PIONEER Subgroup Analyses.,"INTRODUCTION The efficacy and safety of oral semaglutide, the first oral glucagon-like peptide-1 receptor agonist, were investigated in patients with type 2 diabetes (T2D) in the Peptide InnOvatioN for Early diabEtes tReatment (PIONEER) programme. The current post-hoc exploratory subgroup analyses evaluated outcomes by background medication and insulin regimen subgroups. METHODS Data from patients in the PIONEER 3-5, 7 and 8 trials receiving once-daily oral semaglutide (14 mg/flexibly dosed) or a comparator (placebo, sitagliptin 100 mg or liraglutide 1.8 mg) were analysed for efficacy (glycated haemoglobin [HbA 1c ] and body weight changes from baseline to planned end of treatment) and safety outcomes. Patients were grouped according to background medication (metformin, sulphonylurea, thiazolidinedione, sodium-glucose cotransporter-2 inhibitor, insulin, or combinations thereof). Efficacy outcomes were analysed using the trial product estimand (which assumes that patients remained on the trial product without rescue medication use). A separate analysis by background insulin regimen (basal, premixed or basal-bolus) was done for PIONEER 8 using the treatment policy estimand (regardless of trial product discontinuation or rescue medication use). Safety outcomes were analysed descriptively for all patients. RESULTS In total, 2836 patients receiving oral semaglutide 14 mg/flexibly dosed or comparators were included. Baseline characteristics were generally similar across background medication subgroups within each trial. Diabetes duration tended to be longer in patients receiving more background medications. Greater HbA 1c and body weight reductions were seen across background medication subgroups with oral semaglutide (changes from baseline: - 1.0 to - 1.5% and - 2.2 to - 5.0 kg, respectively) than with comparators (except for similar HbA 1c reductions vs liraglutide). There were no statistically significant interactions by treatment and background medication subgroup for change in HbA 1c or body weight except for change in HbA 1c (background insulin vs insulin plus metformin) in PIONEER 8 (p = 0.0408). Changes in HbA 1c and body weight were generally similar across insulin regimen subgroups, without significant treatment interactions by subgroup, and the total daily insulin dose was decreased for patients receiving oral semaglutide. The incidence of adverse events was generally similar in background medication subgroups. CONCLUSION Oral semaglutide was effective at lowering HbA 1c and body weight, regardless of background medications, and appears suitable for a broad range of patients with T2D in combination with other glucose-lowering agents. TRIAL REGISTRATION Clinicaltrials.gov: NCT02607865 (PIONEER 3), NCT02863419 (PIONEER 4), NCT02827708 (PIONEER 5), NCT02849080 (PIONEER 7) and NCT03021187 (PIONEER 8).",2021,"Changes in HbA 1c and body weight were generally similar across insulin regimen subgroups, without significant treatment interactions by subgroup, and the total daily insulin dose was decreased for patients receiving oral semaglutide.","['Patients with Type 2 Diabetes', 'Data from patients in the PIONEER 3-5, 7 and 8 trials receiving once', 'patients with type 2 diabetes (T2D) in the Peptide', '2836 patients receiving']","['Oral Semaglutide', ' Glucose-Lowering Medication', 'oral semaglutide', 'daily oral semaglutide (14\xa0mg/flexibly dosed) or a comparator (placebo, sitagliptin 100\xa0mg or liraglutide', 'background medication (metformin, sulphonylurea, thiazolidinedione, sodium-glucose cotransporter-2 inhibitor, insulin, or combinations thereof']","['Safety outcomes', 'Greater HbA 1c and body weight reductions', 'Changes in HbA 1c and body weight', 'total daily insulin dose', 'adverse events', 'HbA 1c and Body Weight', 'Diabetes duration', 'efficacy (glycated haemoglobin [HbA 1c ] and body weight changes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1812980', 'cui_str': 'sitagliptin 100 MG'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0289779', 'cui_str': '2,4-thiazolidinedione'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]",2836.0,0.0889714,"Changes in HbA 1c and body weight were generally similar across insulin regimen subgroups, without significant treatment interactions by subgroup, and the total daily insulin dose was decreased for patients receiving oral semaglutide.","[{'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Pratley', 'Affiliation': 'AdventHealth Translational Research Institute, Orlando, FL, USA. richard.pratley.md@adventhealth.com.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Crowley', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Duke University Medical Center, and Durham Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham, NC, USA.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Gislum', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Christin L', 'Initials': 'CL', 'LastName': 'Hertz', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Jensen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00994-9'] 2367,33666595,"Acute Inflammatory, Cortisol, and Soreness Responses to Supramaximal Accentuated Eccentric Loading.","ABSTRACT Merrigan, JJ and Jones, MT. Acute inflammatory, cortisol, and soreness responses to supramaximal accentuated eccentric loading. J Strength Cond Res 35(2S): S107-S113, 2021-The purpose was to determine differences in time under tension, cortisol, inflammation, and perceived soreness between accentuated eccentric (AEL) and traditional loading (TRA) resistance exercise protocols. Resistance-trained men (n = 21) completed the AEL and TRA protocols in a random order, separated by 48 hours (sets × reps at eccentric/concentric) as follows: AEL65, 3 × 5 at 120/65% 1 repetition maximum (RM); AEL80, 3 × 3 at 120/80% 1RM; TRA65, 3 × 5 at 65/65% 1RM; and TRA80, 3 × 3 at 80/80% 1RM. Four linear position transducers measured eccentric time under tension (ETUT) and total time under tension (TTUT). Ultrasonography measured vastus lateralis muscle thickness and echo intensity at baseline and immediately post-exercise. Salivary cortisol was assessed at baseline, 0-, 15-, 30-, and 60-minute post-exercise. Perceived soreness was assessed at baseline, 24-, and 48-hours post-exercise. During rep 1, AEL65 and AEL80 had longer ETUT and TTUT than TRA65 (p ≤ 0.002) and TRA80 (p ≤ 0.008), respectively. However, AEL65 had shorter ETUT (reps 3-5) and TTUT (reps 3-5) than TRA65 (p ≤ 0.043). Similarly, ETUT (reps 2-3) and TTUT (rep 3) was shorter in AEL80 than TRA80 (p ≤ 0.045). However, there was no protocol effect for ETUT and TTUT (p > 0.05). Muscle thickness changes were trivial after each protocol (AEL80, d = 0.19; TRA80, d = 0.15; AEL65, d = 0.24; TRA65, d = 0.23), but changes in echo intensity were moderate (AEL80, d = 0.61; TRA80, d = 0.61; AEL65, d = 0.61; TRA65, d = 0.76). Salivary cortisol decreased below baseline at 30- and 60-minute post-exercise (p ≤ 0.006). Perceived soreness elevated from baseline to 24 hours for AEL80 (p = 0.006). The inflammatory, cortisol, and soreness responses after AEL were either low or similar to TRA, indicating similar recovery patterns between protocols.",2021,Salivary cortisol decreased below baseline at 30- and 60-minute post-exercise (p ≤ 0.006).,['Resistance-trained men (n = 21) completed the'],"['AEL and TRA protocols', 'J Strength Cond Res 35(2S']","['Perceived soreness', 'Ultrasonography measured vastus lateralis muscle thickness and echo intensity', 'Salivary cortisol', 'inflammatory, cortisol, and soreness responses', 'time under tension, cortisol, inflammation, and perceived soreness between accentuated eccentric (AEL) and traditional loading (TRA) resistance exercise protocols', 'Acute inflammatory, cortisol, and soreness responses', 'Muscle thickness changes', 'eccentric time under tension (ETUT) and total time under tension (TTUT', 'Acute Inflammatory, Cortisol, and Soreness Responses', 'changes in echo intensity', 'Perceived soreness elevated']","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0023440', 'cui_str': 'Acute myeloid leukemia, M6 type'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1997416', 'cui_str': 'Accentuated'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0486506,Salivary cortisol decreased below baseline at 30- and 60-minute post-exercise (p ≤ 0.006).,"[{'ForeName': 'Justin J', 'Initials': 'JJ', 'LastName': 'Merrigan', 'Affiliation': 'School of Kinesiology, George Mason University, Manassas, Virginia.'}, {'ForeName': 'Margaret T', 'Initials': 'MT', 'LastName': 'Jones', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003764'] 2368,33666156,"Benefits of anakinra versus TNF inhibitors in rheumatoid arthritis and type 2 diabetes: long-term findings from participants furtherly followed-up in the TRACK study, a multicentre, open-label, randomised, controlled trial.","OBJECTIVES Interleukin (IL)-1β is considered a shared pathogenic mediator between rheumatoid arthritis (RA) and type 2 diabetes (T2D). In the TRACK study, participants with both diseases were randomised to an IL-1 inhibitor, anakinra, or a TNF inhibitor (TNFi). After 6 months, anakinra induced a such of improvement on metabolic and inflammatory parameters, leading to a premature stoppage of the study. Thus, we aimed to assess how long IL-1 inhibition benefits lasted. METHODS Since the TRACK was prematurely discontinued for ""early benefit"", we furtherly followed-up the enrolled participants to assess how long persisted the improvement of glycated haemoglobin (HbA1c%) and of RA disease activity. RESULTS After a mean follow-up of 18 months (15 participants in anakinra-group and 14 in TNFi-group), RA clinical response was retained in both groups (DAS28: 2.59±1.01 vs. 2.88±0.91; p=0.109). Concomitant glucocorticoids were reduced in both groups (2.01±0.71 vs. 3.01±0.87 mg/die; p=0.124), but a larger percentage of anakinra-treated participants discontinued such drugs (53.3% vs. 28.6%; p=0.004). There was no difference between anakinra and TNFi for HbA1c% (6.60±0.52 vs. 6.79±0.43; p=0.291), but a reduction of anti-diabetic drugs was observed in anakinra-treated participants (53.3% vs. 7.1%; p=0.008) whereas an increase of anti-diabetic therapies was needed in TNFi-treated ones. Significant correlations were also observed among HbA1c% with DAS28 and with C-reactive protein. Analysing the safety profile, only minor side effects were recorded. CONCLUSIONS Data deriving from the long-term extension of participants with RA and T2D, enrolled in the TRACK study, could suggest that the benefits of IL-1 inhibition on metabolic and inflammatory parameters could last longer than first 6 months of follow-up, but further studies are needed to confirm these findings.",2021,"Concomitant glucocorticoids were reduced in both groups (2.01±0.71 vs. 3.01±0.87 mg/die; p=0.124), but a larger percentage of anakinra-treated participants discontinued such drugs (53.3% vs. 28.6%; p=0.004).","['rheumatoid arthritis and type 2 diabetes', 'participants with both diseases']","['anakinra versus TNF inhibitors', 'IL-1 inhibitor, anakinra, or a TNF inhibitor (TNFi']","['metabolic and inflammatory parameters', 'reduction of anti-diabetic drugs', 'anti-diabetic therapies', 'Concomitant glucocorticoids', 'RA clinical response', 'glycated haemoglobin (HbA1c%) and of RA disease activity']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0245109', 'cui_str': 'anakinra'}, {'cui': 'C3537192', 'cui_str': 'TNF Antagonists'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.151977,"Concomitant glucocorticoids were reduced in both groups (2.01±0.71 vs. 3.01±0.87 mg/die; p=0.124), but a larger percentage of anakinra-treated participants discontinued such drugs (53.3% vs. 28.6%; p=0.004).","[{'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Ruscitti', 'Affiliation': ""Rheumatology, Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, Italy. piero.ruscitti@univaq.it.""}, {'ForeName': 'Onorina', 'Initials': 'O', 'LastName': 'Berardicurti', 'Affiliation': ""Rheumatology, Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, Italy.""}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Cipriani', 'Affiliation': ""Rheumatology, Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, Italy.""}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Giacomelli', 'Affiliation': ""Rheumatology and Immunology Unit, Department of Medicine, University of Rome 'Campus Biomedico', Rome, Italy.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical and experimental rheumatology,[] 2369,33663034,Comparison of chronic kidney disease trial designs and analysis strategies.,"BACKGROUND Despite the large burden of chronic kidney disease (CKD), it is challenging to conduct adequately powered clinical trials in this setting. Sound and efficient trials are needed to advance treatment. Various analysis strategies can be used to compare the efficacy of a parallel trial design with that of three two period trial designs. METHODS The type 1 error rates and powers of various trial designs were calculated using simulated data from models fit to two recent CKD trials. In addition, we assessed the influences of a variety of analysis strategies and of the presence of a carryover effect. RESULTS The parallel and crossover designs (with analysis of change from baseline to the off treatment value) maintained the target type 1 error rate in all scenarios. In some scenarios, an open label design yielded inflated type 1 error rates. In many scenarios, the open label and delayed start designs had unacceptably low power and high type 1 error rates. Overall, the crossover design had the highest power by far, and always controlled the type 1 error rate. CONCLUSION The recommended approach to a CKD trial is a two period design with an endpoint that is the rate of change in estimated glomerular filtration rate from pretreatment to off treatment. As compared to a parallel trial, a crossover study involves a considerably smaller sample size and shorter total follow-up duration. A crossover design may also be preferable for patients, and facilitates recruitment of a sufficient number of subjects.",2021,"As compared to a parallel trial, a crossover study involves a considerably smaller sample size and shorter total follow-up duration.",[],[],['glomerular filtration rate'],[],[],"[{'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]",,0.101914,"As compared to a parallel trial, a crossover study involves a considerably smaller sample size and shorter total follow-up duration.","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lawrence', 'Affiliation': 'Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States.'}]",Kidney research and clinical practice,['10.23876/j.krcp.20.104'] 2370,33662102,Effect of Ivermectin on Time to Resolution of Symptoms Among Adults With Mild COVID-19: A Randomized Clinical Trial.,"Importance Ivermectin is widely prescribed as a potential treatment for COVID-19 despite uncertainty about its clinical benefit. Objective To determine whether ivermectin is an efficacious treatment for mild COVID-19. Design, Setting, and Participants Double-blind, randomized trial conducted at a single site in Cali, Colombia. Potential study participants were identified by simple random sampling from the state's health department electronic database of patients with symptomatic, laboratory-confirmed COVID-19 during the study period. A total of 476 adult patients with mild disease and symptoms for 7 days or fewer (at home or hospitalized) were enrolled between July 15 and November 30, 2020, and followed up through December 21, 2020. Intervention Patients were randomized to receive ivermectin, 300 μg/kg of body weight per day for 5 days (n = 200) or placebo (n = 200). Main Outcomes and Measures Primary outcome was time to resolution of symptoms within a 21-day follow-up period. Solicited adverse events and serious adverse events were also collected. Results Among 400 patients who were randomized in the primary analysis population (median age, 37 years [interquartile range {IQR}, 29-48]; 231 women [58%]), 398 (99.5%) completed the trial. The median time to resolution of symptoms was 10 days (IQR, 9-13) in the ivermectin group compared with 12 days (IQR, 9-13) in the placebo group (hazard ratio for resolution of symptoms, 1.07 [95% CI, 0.87 to 1.32]; P = .53 by log-rank test). By day 21, 82% in the ivermectin group and 79% in the placebo group had resolved symptoms. The most common solicited adverse event was headache, reported by 104 patients (52%) given ivermectin and 111 (56%) who received placebo. The most common serious adverse event was multiorgan failure, occurring in 4 patients (2 in each group). Conclusion and Relevance Among adults with mild COVID-19, a 5-day course of ivermectin, compared with placebo, did not significantly improve the time to resolution of symptoms. The findings do not support the use of ivermectin for treatment of mild COVID-19, although larger trials may be needed to understand the effects of ivermectin on other clinically relevant outcomes. Trial Registration ClinicalTrials.gov Identifier: NCT04405843.",2021,"The most common solicited adverse event was headache, reported by 104 patients (52%) given ivermectin and 111 (56%) who received placebo.","['Adults With Mild COVID-19', '476 adult patients with mild disease and symptoms for 7 days or fewer (at home or hospitalized) were enrolled between July 15 and November 30, 2020, and followed up through December 21, 2020', '400 patients who were randomized in the primary analysis population (median age, 37 years [interquartile range {IQR}, 29-48]; 231 women [58%]), 398 (99.5%) completed the trial', ""Potential study participants were identified by simple random sampling from the state's health department electronic database of patients with symptomatic, laboratory-confirmed COVID-19 during the study period""]","['ivermectin', 'Ivermectin', 'placebo']","['Solicited adverse events and serious adverse events', 'Time to Resolution of Symptoms', 'median time to resolution of symptoms', 'time to resolution of symptoms within a 21-day follow-up period', 'resolved symptoms', 'time to resolution of symptoms']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517912', 'cui_str': '99.5'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]","[{'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3714811', 'cui_str': 'Resolved'}]",476.0,0.796874,"The most common solicited adverse event was headache, reported by 104 patients (52%) given ivermectin and 111 (56%) who received placebo.","[{'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'López-Medina', 'Affiliation': 'Centro de Estudios en Infectología Pediátrica, Cali, Colombia.'}, {'ForeName': 'Pío', 'Initials': 'P', 'LastName': 'López', 'Affiliation': 'Centro de Estudios en Infectología Pediátrica, Cali, Colombia.'}, {'ForeName': 'Isabel C', 'Initials': 'IC', 'LastName': 'Hurtado', 'Affiliation': 'Department of Pediatrics, Universidad del Valle, Cali, Colombia.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Dávalos', 'Affiliation': 'Department of Public Health, Universidad Icesi, Cali, Colombia.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Ramirez', 'Affiliation': 'Clínica Imbanaco, Cali, Colombia.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Martínez', 'Affiliation': 'Department of Internal Medicine, Universidad del Valle, Cali, Colombia.'}, {'ForeName': 'Jesus A', 'Initials': 'JA', 'LastName': 'Díazgranados', 'Affiliation': 'Neurólogos de Occidente, Cali, Colombia.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Oñate', 'Affiliation': 'Clínica Imbanaco, Cali, Colombia.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Chavarriaga', 'Affiliation': 'Municipal Health Department, Cali, Colombia.'}, {'ForeName': 'Sócrates', 'Initials': 'S', 'LastName': 'Herrera', 'Affiliation': 'Caucaseco Scientific Research Center, Malaria Vaccine and Drug Development Center, Cali, Colombia.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Parra', 'Affiliation': 'Department of Microbiology, Universidad del Valle, Cali, Colombia.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Libreros', 'Affiliation': 'Department of Microbiology, Universidad del Valle, Cali, Colombia.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Jaramillo', 'Affiliation': 'Hemato Oncólogos, Cali, Colombia.'}, {'ForeName': 'Ana C', 'Initials': 'AC', 'LastName': 'Avendaño', 'Affiliation': 'Hemato Oncólogos, Cali, Colombia.'}, {'ForeName': 'Dilian F', 'Initials': 'DF', 'LastName': 'Toro', 'Affiliation': 'Health Experts Committee, Valle del Cauca, Colombia.'}, {'ForeName': 'Miyerlandi', 'Initials': 'M', 'LastName': 'Torres', 'Affiliation': 'Municipal Health Department, Cali, Colombia.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Lesmes', 'Affiliation': 'State Health Department, Valle del Cauca, Colombia.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Rios', 'Affiliation': 'Centro Médico Santuario, Cali, Colombia.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Caicedo', 'Affiliation': 'Clínica Imbanaco, Cali, Colombia.'}]",JAMA,['10.1001/jama.2021.3071'] 2371,33669119,The Effect of Kefir Supplementation on Improving Human Endurance Exercise Performance and Antifatigue.,"Kefir is an acidic, carbonated, and fermented dairy product produced by fermenting milk with kefir grains. The Lactobacillus species constitutes an important part of kefir grains. In a previous animal study, kefir effectively improved exercise performance and had anti-fatigue effects. The purpose of this research was to explore the benefits of applying kefir to improve exercise performance, reduce fatigue, and improve physiological adaptability in humans. The test used a double-blind crossover design and supplementation for 28 days. Sixteen 20-30 year-old subjects were divided into two groups in a balanced order according to each individual's initial maximal oxygen uptake and were assigned to receive a placebo (equal flavor, equal calories, 20 g/day) or SYNKEFIR™ (20 g/day) every morning. After the intervention, there were 28 days of wash-out, during which time the subjects did not receive further interventions. After supplementation with SYNKEFIR™, the exercise time to exhaustion was significantly greater than that before ingestion ( p = 0.0001) and higher than that in the Placebo group by 1.29-fold ( p = 0.0004). In addition, compared with the Placebo group, the SYNKEFIR™ administration group had significantly lower lactate levels in the exercise and recovery ( p < 0.05). However, no significant difference was observed in the changes in the gut microbiota. Although no significant changes in body composition were found, SYNKEFIR™ did not cause adverse reactions or harm to the participants' bodies. In summary, 28 days of supplementation with SYNKEFIR™ significantly improved exercise performance, reduced the production of lactic acid after exercise, and accelerated recovery while also not causing any adverse reactions.",2021,"Although no significant changes in body composition were found, SYNKEFIR™ did not cause adverse reactions or harm to the participants' bodies.","['Sixteen 20-30 year-old subjects', 'humans']","['Kefir Supplementation', 'placebo (equal flavor, equal calories, 20 g/day) or SYNKEFIR™', 'Placebo']","['body composition', 'gut microbiota', 'production of lactic acid', 'exercise performance', 'Human Endurance Exercise Performance and Antifatigue', 'lactate levels', 'exercise time to exhaustion']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0524649', 'cui_str': 'Kefir'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0450403', 'cui_str': '20G'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0064582', 'cui_str': 'lactic acid'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}, {'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}, {'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}]",,0.0835925,"Although no significant changes in body composition were found, SYNKEFIR™ did not cause adverse reactions or harm to the participants' bodies.","[{'ForeName': 'Mon-Chien', 'Initials': 'MC', 'LastName': 'Lee', 'Affiliation': 'Graduate Institute of Sports Science, National Taiwan Sport University, Taoyuan 333325, Taiwan.'}, {'ForeName': 'Wei-Lun', 'Initials': 'WL', 'LastName': 'Jhang', 'Affiliation': 'Graduate Institute of Sports Science, National Taiwan Sport University, Taoyuan 333325, Taiwan.'}, {'ForeName': 'Chia-Chia', 'Initials': 'CC', 'LastName': 'Lee', 'Affiliation': 'Culture Collection & Research Institute, Synbio Tech Incorporation, Kaohsiung 821, Taiwan.'}, {'ForeName': 'Nai-Wen', 'Initials': 'NW', 'LastName': 'Kan', 'Affiliation': 'Center for General Education, Taipei Medical University, Taipei 11031, Taiwan.'}, {'ForeName': 'Yi-Ju', 'Initials': 'YJ', 'LastName': 'Hsu', 'Affiliation': 'Graduate Institute of Sports Science, National Taiwan Sport University, Taoyuan 333325, Taiwan.'}, {'ForeName': 'Chin-Shan', 'Initials': 'CS', 'LastName': 'Ho', 'Affiliation': 'Graduate Institute of Sports Science, National Taiwan Sport University, Taoyuan 333325, Taiwan.'}, {'ForeName': 'Chun-Hao', 'Initials': 'CH', 'LastName': 'Chang', 'Affiliation': 'Graduate Institute of Sports Science, National Taiwan Sport University, Taoyuan 333325, Taiwan.'}, {'ForeName': 'Yi-Chen', 'Initials': 'YC', 'LastName': 'Cheng', 'Affiliation': 'Culture Collection & Research Institute, Synbio Tech Incorporation, Kaohsiung 821, Taiwan.'}, {'ForeName': 'Jin-Seng', 'Initials': 'JS', 'LastName': 'Lin', 'Affiliation': 'Culture Collection & Research Institute, Synbio Tech Incorporation, Kaohsiung 821, Taiwan.'}, {'ForeName': 'Chi-Chang', 'Initials': 'CC', 'LastName': 'Huang', 'Affiliation': 'Graduate Institute of Sports Science, National Taiwan Sport University, Taoyuan 333325, Taiwan.'}]",Metabolites,['10.3390/metabo11030136'] 2372,33669067,"Comparison of Immunogenicity and Safety between a Single Dose and One Booster Trivalent Inactivated Influenza Vaccination in Patients with Chronic Kidney Disease: A 20-Week, Open-Label Trial.","BACKGROUND Non-dialysis-dependent chronic kidney disease (CKD-ND) patients are recommended to receive a one-dose influenza vaccination annually. However, studies investigating vaccine efficacy in the CKD-ND population are still lacking. In this study, we aimed to evaluate vaccine efficacy between the one-dose and two-dose regimen and among patients with different stages of CKD throughout a 20-week follow-up period. METHODS We conducted a single-center, non-randomized, open-label, controlled trial among patients with all stages of CKD-ND. Subjects were classified as unvaccinated, one-dose, and two-dose groups (4 weeks apart) after enrollment. Serial changes in immunological parameters (0, 4, 8, and 20 weeks after enrollment), including seroprotection, geometric mean titer (GMT), GMT fold-increase, seroconversion, and seroresponse, were applied to evaluate vaccine efficacy. RESULTS There were 43, 84, and 71 patients in the unvaccinated, one-dose, and two-dose vaccination groups, respectively. At 4-8 weeks after vaccination, seroprotection rates in the one- and two-dose group for H1N1, H3N2, and B ranged from 82.6-95.8%, 97.4-100%, and 73.9-100%, respectively. The concomitant seroconversion and GMT fold-increases nearly met the suggested criteria for vaccine efficacy for the elderly population. Although the seroprotection rates for all of the groups were adequate, the seroconversion and GMT fold-increase at 20 weeks after vaccination did not meet the criteria for vaccine efficacy. The two-dose regimen had a higher probability of achieving seroprotection for B strains (Odds ratio: 3.5, 95% confidence interval (1.30-9.40)). No significant differences in vaccine efficacy were found between early (stage 1-3) and late (stage 4-5) stage CKD. CONCLUSIONS The standard one-dose vaccination can elicit sufficient protective antibodies. The two-dose regimen induced a better immune response when the baseline serum antibody titer was low. Monitoring change in antibody titers for a longer duration is warranted to further determine the current vaccine strategy in CKD-ND population.",2021,"No significant differences in vaccine efficacy were found between early (stage 1-3) and late (stage 4-5) stage CKD. CONCLUSIONS ","['Patients with Chronic Kidney Disease', 'patients with all stages of CKD-ND', 'patients with different stages of CKD throughout a 20-week follow-up period', 'Non-dialysis-dependent chronic kidney disease (CKD-ND) patients']",['Single Dose and One Booster Trivalent Inactivated Influenza Vaccination'],"['vaccine efficacy', 'Immunogenicity and Safety', 'antibody titers', 'higher probability of achieving seroprotection', 'seroprotection rates', 'seroprotection, geometric mean titer (GMT), GMT fold-increase, seroconversion, and seroresponse']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}]",,0.055444,"No significant differences in vaccine efficacy were found between early (stage 1-3) and late (stage 4-5) stage CKD. CONCLUSIONS ","[{'ForeName': 'Yu-Tzu', 'Initials': 'YT', 'LastName': 'Chang', 'Affiliation': 'Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan 704, Taiwan.'}, {'ForeName': 'Tsai-Chieh', 'Initials': 'TC', 'LastName': 'Ling', 'Affiliation': 'Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan 704, Taiwan.'}, {'ForeName': 'Ya-Yun', 'Initials': 'YY', 'LastName': 'Cheng', 'Affiliation': 'Department of Environmental Health, T.H Chan School of Public Health, Harvard University, Boston, MA 02115, USA.'}, {'ForeName': 'Chien-Yao', 'Initials': 'CY', 'LastName': 'Sun', 'Affiliation': 'Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan 704, Taiwan.'}, {'ForeName': 'Jia-Ling', 'Initials': 'JL', 'LastName': 'Wu', 'Affiliation': 'Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan 704, Taiwan.'}, {'ForeName': 'Ching Hui', 'Initials': 'CH', 'LastName': 'Tai', 'Affiliation': 'Department of Medical Laboratory Science and Biotechnology, College of Medicine, National Cheng Kung University, Tainan 704, Taiwan.'}, {'ForeName': 'Jen-Ren', 'Initials': 'JR', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Laboratory Science and Biotechnology, College of Medicine, National Cheng Kung University, Tainan 704, Taiwan.'}, {'ForeName': 'Junne-Ming', 'Initials': 'JM', 'LastName': 'Sung', 'Affiliation': 'Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan 704, Taiwan.'}]",Vaccines,['10.3390/vaccines9030192'] 2373,33668849,Prenatal Maternal Docosahexaenoic Acid (DHA) Supplementation and Newborn Anthropometry in India: Findings from DHANI.,"Long-chain omega-3 fatty acid status during pregnancy may influence newborn anthropometry and duration of gestation. Evidence from high-quality trials from low- and middle-income countries (LMICs) is limited. We conducted a double-blind, randomized, placebo-controlled trial among 957 pregnant women (singleton gestation, 14-20 weeks' gestation at enrollment) in India to test the effectiveness of 400 mg/day algal docosahexaenoic acid (DHA) compared to placebo provided from enrollment through delivery. Among 3379 women who were screened, 1171 were found eligible; 957 were enrolled and were randomized. The intervention was two microencapsulated algal DHA (200 × 2 = 400 mg/day) or two microencapsulated soy and corn oil placebo tablets to be consumed daily from enrollment (≤20 weeks) through delivery. The primary outcome was newborn anthropometry (birth weight, length, head circumference). Secondary outcomes were gestational age and 1 and 5 min Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) score. The groups (DHA; n = 478 and placebo; n = 479) were well balanced at baseline. There were 902 live births. Compliance with the intervention was similar across groups (DHA: 88.5%; placebo: 87.1%). There were no significant differences between DHA and placebo groups for birth weight (2750.6 ± 421.5 vs. 2768.2 ± 436.6 g, p = 0.54), length (47.3 ± 2.0 vs. 47.5 ± 2.0 cm, p = 0.13), or head circumference (33.7 ± 1.4 vs. 33.8 ± 1.4 cm, p = 0.15). The mean gestational age at delivery was similar between groups (DHA: 38.8 ± 1.7 placebo: 38.8 ± 1.7 wk, p = 0.54) as were APGAR scores at 1 and 5 min. Supplementing mothers through pregnancy with 400 mg/day DHA did not impact the offspring's birthweight, length, or head circumference.",2021,Compliance with the intervention was similar across groups (DHA: 88.5%; placebo: 87.1%).,"[""957 pregnant women (singleton gestation, 14-20 weeks' gestation at enrollment) in India to test the effectiveness of 400 mg"", '3379 women who were screened, 1171 were found eligible; 957 were enrolled and were randomized']","['day algal docosahexaenoic acid (DHA', 'placebo', 'microencapsulated soy and corn oil placebo tablets', 'Prenatal Maternal Docosahexaenoic Acid (DHA) Supplementation', 'microencapsulated algal DHA']","['newborn anthropometry and duration of gestation', 'mean gestational age at delivery', 'birthweight, length, or head circumference', 'gestational age and 1 and 5 min Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) score', 'birth weight', 'newborn anthropometry (birth weight, length, head circumference', 'APGAR scores']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0010029', 'cui_str': 'Corn Oil'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0556102', 'cui_str': 'Docosahexaenoic acid supplementation'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0460089', 'cui_str': 'Finding of length of gestation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0239779', 'cui_str': 'Grimaces'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}]",957.0,0.781465,Compliance with the intervention was similar across groups (DHA: 88.5%; placebo: 87.1%).,"[{'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Khandelwal', 'Affiliation': 'Public Health Foundation of India, Gurugram 122003, India.'}, {'ForeName': 'Dimple', 'Initials': 'D', 'LastName': 'Kondal', 'Affiliation': 'Public Health Foundation of India, Gurugram 122003, India.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Chaudhry', 'Affiliation': 'Public Health Foundation of India, Gurugram 122003, India.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Patil', 'Affiliation': ""Department of Obstetrics and Gynaecology, KAHER's J. N. Medical College, Belagavi 590010, India.""}, {'ForeName': 'Mallaiah Kenchaveeraiah', 'Initials': 'MK', 'LastName': 'Swamy', 'Affiliation': ""Department of Obstetrics and Gynaecology, KAHER's J. N. Medical College, Belagavi 590010, India.""}, {'ForeName': 'Gangubai', 'Initials': 'G', 'LastName': 'Pujeri', 'Affiliation': ""Department of Obstetrics and Gynaecology, KAHER's J. N. Medical College, Belagavi 590010, India.""}, {'ForeName': 'Swati Babu', 'Initials': 'SB', 'LastName': 'Mane', 'Affiliation': ""Department of Obstetrics and Gynaecology, KAHER's J. N. Medical College, Belagavi 590010, India.""}, {'ForeName': 'Yashaswi', 'Initials': 'Y', 'LastName': 'Kudachi', 'Affiliation': ""Department of Obstetrics and Gynaecology, KAHER's J. N. Medical College, Belagavi 590010, India.""}, {'ForeName': 'Ruby', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Public Health Foundation of India, Gurugram 122003, India.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Ramakrishnan', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA 30322, USA.'}, {'ForeName': 'Aryeh D', 'Initials': 'AD', 'LastName': 'Stein', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA 30322, USA.'}, {'ForeName': 'Dorairaj', 'Initials': 'D', 'LastName': 'Prabhakaran', 'Affiliation': 'Public Health Foundation of India, Gurugram 122003, India.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Tandon', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi 110016, India.'}]",Nutrients,['10.3390/nu13030730'] 2374,33667304,Supplemental Intraoperative Oxygen and Long-term Mortality: Subanalysis of a Multiple Crossover Cluster Trial.,"BACKGROUND Whether supplemental oxygen worsens long-term mortality remains unclear, with contradictory trial results. The authors therefore tested the hypothesis that supplemental oxygen (80% vs. 30%) increases the hazard for long-term mortality. METHODS The authors conducted a post hoc analysis of a large multiple crossover cluster trial in which more than 5,000 colorectal surgeries on 4,088 adults were allocated to receive either 30% or 80% inspired oxygen during general anesthesia. The authors assessed the effect of 80% versus 30% target-inspired oxygen on long-term mortality and calculated Kaplan-Meier survival estimates. Analysis was restricted to patients with a home address in Ohio because the authors could obtain reliable vital status information from the Ohio Department of Health (Columbus, Ohio) for them. RESULTS A total of 3,471 qualifying colorectal surgeries performed in 2,801 patients were analyzed, including 1,753 (51%) surgeries in 1,577 patients given 80% oxygen and 1,718 surgeries in 1,551 patients given 30% oxygen. The observed incidence of death after a median of 3 yr was 13% (234 of 1,753) in the 80% oxygen group and 14% (245 of 1,718) in the 30% oxygen group. The estimated hazard ratio for mortality was 0.94 (95% CI, 0.78 to 1.13; P = 0.493). CONCLUSIONS In this post hoc analysis of a large, controlled trial, supplemental oxygen did not increase postoperative mortality. EDITOR’S PERSPECTIVE ",2021,"The observed incidence of death after a median of 3 yr was 13% (234 of 1,753) in the 80% oxygen group and 14% (245 of 1,718) in the 30% oxygen group.","['3,471 qualifying colorectal surgeries performed in 2,801 patients were analyzed, including 1,753 (51%) surgeries in 1,577 patients given 80% oxygen and 1,718 surgeries in 1,551 patients given 30% oxygen', '5,000 colorectal surgeries on 4,088 adults']",['30% or 80% inspired oxygen during general anesthesia'],"['inspired oxygen on long-term mortality and calculated Kaplan-Meier survival estimates', 'hazard for long-term mortality', 'estimated hazard ratio for mortality', 'postoperative mortality', 'death']","[{'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",2801.0,0.508618,"The observed incidence of death after a median of 3 yr was 13% (234 of 1,753) in the 80% oxygen group and 14% (245 of 1,718) in the 30% oxygen group.","[{'ForeName': 'Qiliang', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Kurz', 'Affiliation': ''}, {'ForeName': 'Xiaobao', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003694'] 2375,33674999,"Comment on ""Cost-Effectiveness of Cannabidiol Adjunct Therapy Versus Usual Care for the Treatment of Seizures in Lennox-Gastaut Syndrome"".",,2021,,[],['Cannabidiol Adjunct Therapy Versus Usual Care'],[],[],"[{'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]",[],,0.0151455,,"[{'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Hollenack', 'Affiliation': 'Greenwich Biosciences, Inc., 5750 Fleet Street, Suite 200, Carlsbad, CA, 92008, USA. KHollenack@greenwichbiosciences.com.'}, {'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': 'GW Pharma Ltd, London, UK.'}]",PharmacoEconomics,['10.1007/s40273-021-01005-w'] 2376,33676071,Sex and female empowerment (SAFE): A randomized trial comparing sexual health interventions for women in treatment for opioid use disorder.,"BACKGROUND Unintended pregnancies are prevalent among women with opioid use disorder (OUD). The Sex and Female Empowerment (SAFE) project developed a social-cognitive, theory-driven intervention to increase acceptance of and adherence to contraceptive practices among women receiving medication for OUD (MOUD). This study evaluated the feasibility and acceptability of two SAFE interventions (Face-to-face and Computer-adapted) compared to usual care as well as their efficacy to improve contraception utilization. METHODS This pilot randomized trial enrolled 90 heterosexual, non-pregnant, reproductive-age women receiving MOUD. Participants were randomized into either a: SAFE Face-to-face intervention, SAFE Computer-adapted intervention, or usual care (UC) condition (n = 30 each) and followed for 6 months. Outcome measures included intervention completion, intervention satisfaction, attendance at a contraception consultation appointment, and long-acting reversible contraceptive (LARC) method receipt. A generalized linear model was used for inferential testing and to estimate least squares means (predicted probabilities for binary outcomes) and their standard errors. RESULTS Compared to the UC condition, both the SAFE Face-to-face and the SAFE Computer-adapted intervention had higher intervention completion [Means (Standard Errors) = 0.97 (.03) and 0.97 (.03), respectively, vs. 0.53 (.09); ps<.001], higher intervention satisfaction [Ms (SEs) = 3.7 (.11) and 3.8 (.11), respectively, vs. 3.1 (.11); ps<0.001), higher contraception consultation visit attendance [Ms(SEs) = 0.80 (.07) and 0.73 (.08) vs. 0.33 (.09); p < .001], and greater LARC receipt [Ms(SEs) = 0.77 (.08) and 0.73 (.08) vs. 0.23 (.08); p < .001). CONCLUSIONS SAFE appears feasible and efficacious for supporting women in contraception decision-making. Integrating SAFE into women's comprehensive OUD treatment services holds promise to increase contraceptive decision-making and initiation of a chosen method.",2021,"Compared to the UC condition, both the SAFE Face-to-face and the SAFE Computer-adapted intervention had higher intervention completion [Means (Standard Errors) =","['women receiving medication for OUD (MOUD', '90 heterosexual, non-pregnant, reproductive-age women receiving MOUD', 'women with opioid use disorder (OUD', 'women in treatment for opioid use disorder', 'Sex and female empowerment (SAFE']","['SAFE interventions (Face-to-face and Computer-adapted', 'sexual health interventions', 'SAFE', 'SAFE Face-to-face intervention, SAFE Computer-adapted intervention, or usual care (UC) condition']","['intervention completion, intervention satisfaction, attendance at a contraception consultation appointment, and long-acting reversible contraceptive (LARC) method receipt', 'higher contraception consultation visit attendance']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}]","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205250', 'cui_str': 'High'}]",90.0,0.046039,"Compared to the UC condition, both the SAFE Face-to-face and the SAFE Computer-adapted intervention had higher intervention completion [Means (Standard Errors) =","[{'ForeName': 'Hendrée E', 'Initials': 'HE', 'LastName': 'Jones', 'Affiliation': 'UNC Horizons and Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC 27510, United States; Departments of Psychiatry and Behavioral Sciences and Obstetrics and Gynecology, School of Medicine, Johns Hopkins University, Baltimore, MD 21224 United States. Electronic address: Hendree_Jones@med.unc.edu.'}, {'ForeName': 'Caitlin E', 'Initials': 'CE', 'LastName': 'Martin', 'Affiliation': 'Department of Obstetrics and Gynecology & Institute of Drug and Alcohol Studies, Virginia Commonwealth University School of Medicine, Richmond, VA 23298, United States.'}, {'ForeName': 'Kimberly R', 'Initials': 'KR', 'LastName': 'Andringa', 'Affiliation': 'UNC Horizons and Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC 27510, United States.'}, {'ForeName': 'Rachel Middlesteadt', 'Initials': 'RM', 'LastName': 'Ellerson', 'Affiliation': 'UNC Horizons and Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC 27510, United States.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Johnson', 'Affiliation': 'UNC Horizons and Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC 27510, United States.'}, {'ForeName': 'Essence', 'Initials': 'E', 'LastName': 'Hairston', 'Affiliation': 'UNC Horizons and Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC 27510, United States.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': ""O' Grady"", 'Affiliation': 'Department of Psychology, University of Maryland, College Park, College Park, MD 20742, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.108634'] 2377,33676009,Medial Prefrontal High-Definition Transcranial Direct Current Stimulation to Improve Pain Modulation in Chronic Low Back Pain: A Pilot Randomized Double-blinded Placebo-Controlled Crossover Trial.,"Chronic low back pain (CLBP) is highly disabling, but often without identifiable source. Focus has been on impaired anti-nociceptive mechanisms contributing to pain maintenance, though methods of targeting this impairment remain limited. This randomised-controlled cross-over pilot trial used active versus sham medial prefrontal cortex (mPFC) high-definition transcranial direct current stimulation (HD-tDCS) for 3-consecutive days to improve descending pain inhibitory function. Twelve CLBP patients were included with an average visual analogue scale (VAS) pain intensity of 3.0 ± 1.5 and pain duration of 5.3 ± 2.6 years. Pressure pain thresholds (PPTs), conditioned pain modulation (CPM), and temporal summation of pain (TSP) assessed by cuff algometry, as well as pain symptomatology (intensity, unpleasantness, quality, disability) and related psychological features (pain catastrophizing, anxiety, affect), were assessed on Day1 before 3 consecutive days of HD-tDCS sessions (each 20 minutes), at 24-hours (Day 4) and 2-weeks (Day 21) following final HD-tDCS. Blinding was successful. No significant differences in psychophysical (PPT, CPM, TSP), symptomatology or psychological outcomes were observed between active and sham HD-tDCS on Day4 and Day21. CPM-effects at Day 1 negatively correlated with change in CPM-effect at Day4 following active HD-tDCS (P = .002). Lack of efficacy was attributed to several factors, not least that patients did not display impaired CPM at baseline. TRIAL REGISTRATION: : ClinicalTrials.gov (NCT03864822). PERSPECTIVE: Medial prefrontal HD-tDCS did not alter pain, psychological nor psychophysical outcomes, though correlational analysis suggested response may depend on baseline pain inhibitory efficacy, with best potential effects in patients with severe impairments in descending pain inhibitory mechanisms. Future work should focus on appropriate patient selection and optimising stimulation targeting.",2021,"No significant differences in psychophysical (PPT, CPM, TSP), symptomatology or psychological outcomes were observed between active and sham HD-tDCS on Day4 and Day21.","['Chronic Low Back Pain', 'Twelve CLBP patients', 'Chronic low back pain (CLBP', 'patients with severe impairments in descending pain inhibitory mechanisms']","['Placebo', 'Medial Prefrontal High-Definition Transcranial Direct Current Stimulation', 'active versus sham medial prefrontal cortex (mPFC) high-definition transcranial direct current stimulation (HD-tDCS']","['Pressure pain thresholds (PPTs), conditioned pain modulation (CPM), and temporal summation of pain (TSP) assessed by cuff algometry, as well as pain symptomatology (intensity, unpleasantness, quality, disability) and related psychological features (pain catastrophizing, anxiety, affect', 'psychophysical (PPT, CPM, TSP), symptomatology or psychological outcomes', 'CPM-effects', 'average visual analogue scale (VAS) pain intensity']","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0032334', 'cui_str': 'podofilox'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",12.0,0.469232,"No significant differences in psychophysical (PPT, CPM, TSP), symptomatology or psychological outcomes were observed between active and sham HD-tDCS on Day4 and Day21.","[{'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'McPhee', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), Aalborg University, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Graven-Nielsen', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), Aalborg University, Denmark. Electronic address: tgn@hst.aau.dk.'}]",The journal of pain,['10.1016/j.jpain.2021.02.012'] 2378,33675624,In Site Placement vs. Anterior Transposition of the Ulnar Nerve for Distal Humerus Fractures Treated with Plate Fixation: A Multi Centre Randomized Controlled Trial.,"OBJECTIVES To compare clinical scores and electrodiagnostic evidence of ulnar neuropathy, between ulnar nerve mobilization and placement back in the cubital tunnel versus anterior transposition, during plate and screw fixation of a bicolumnar fracture of the distal humerus. DESIGN Multi-centre randomized controlled trial. SETTING Eight tertiary care centres in Canada. PATIENTS Fifty-eight patients with distal humerus fractures undergoing plate fixation of both columns were recruited and randomized. INTERVENTION All patients underwent bicolumnar plate fixation for an acute, displaced fracture of the distal humerus with identification, mobilization and protection of the ulnar nerve as part of the surgical approach. At the conclusion of the procedure they randomized to either 1) replacing the nerve in situ in the cubital tunnel or 2) anterior transposition. MAIN OUTCOME MEASUREMENTS The primary outcome was the Gabel & Amadio rating scale for ulnar neuropathy. Secondary outcomes included a functional outcome score (Mayo Elbow Performance Score [MEPS]), Disabilities of the Arm, Shoulder and Hand Instrument (DASH), two-point discrimination, nerve conduction testing, complications and secondary surgeries. RESULTS Thirty-one patients were randomized to in situ placement, and twenty-seven to anterior transposition. The mean age was 53 years, and 60% were women. There was no difference between the two groups with regards to age, gender, Body Mass Index (BMI), smoking, diabetes, injury characteristics, time to operation, length of operation, or surgical approach. There was no difference in outcome between the two groups at any time point with regards to Gabel & Amadio ulnar neuropathy scores, MEPS scores, DASH, or two-point discrimination. The incidence of ulnar nerve dysfunction as measured by use of the Gabel & Amadio ulnar neuropathy score, was poor in both groups acutely; however, there was significant improvement at 12 months post-operatively (6.0 to 7.8, p<0.001). CONCLUSIONS This study was unable to demonstrate any significant difference in outcomes when comparing ulnar nerve mobilization and in situ placement and anterior subcutaneous transposition following bicolumnar plate fixation of a distal humerus fracture. Either strategy for managing the ulnar nerve is acceptable and can be used at the discretion of the treating surgeon. LEVEL OF EVIDENCE Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2021,"There was no difference in outcome between the two groups at any time point with regards to Gabel & Amadio ulnar neuropathy scores, MEPS scores, DASH, or two-point discrimination.","['Thirty-one patients', 'Fifty-eight patients with distal humerus fractures undergoing plate fixation of both columns were recruited and randomized', 'The mean age was 53 years, and 60% were women', 'Eight tertiary care centres in Canada']","['bicolumnar plate fixation', 'Plate Fixation']","['Body Mass Index (BMI), smoking, diabetes, injury characteristics, time to operation, length of operation, or surgical approach', 'Gabel & Amadio rating scale for ulnar neuropathy', 'incidence of ulnar nerve dysfunction', 'functional outcome score (Mayo Elbow Performance Score [MEPS]), Disabilities of the Arm, Shoulder and Hand Instrument (DASH), two-point discrimination, nerve conduction testing, complications and secondary surgeries', 'Gabel & Amadio ulnar neuropathy score', 'time point with regards to Gabel & Amadio ulnar neuropathy scores, MEPS scores, DASH, or two-point discrimination']","[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0588211', 'cui_str': 'Bone structure of distal humerus'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C1185738', 'cui_str': 'Column structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0449446', 'cui_str': 'Surgical approach'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0154743', 'cui_str': 'Ulnar neuropathy'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0041602', 'cui_str': 'Structure of ulnar nerve'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0200125', 'cui_str': 'Nerve conduction study'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0054871', 'cui_str': 'Cathepsin L'}]",31.0,0.104165,"There was no difference in outcome between the two groups at any time point with regards to Gabel & Amadio ulnar neuropathy scores, MEPS scores, DASH, or two-point discrimination.","[{'ForeName': 'Niloofar', 'Initials': 'N', 'LastName': 'Dehghan', 'Affiliation': ""The CORE Institute, Phoenix, Arizona, USA Department of Orthopaedic Surgery, University of Arizona College of Medicine-Phoenix, Phoenix, Arizona, USA University of Toronto and St. Michael's Hospital, Toronto, Ontario, Canada Division of Orthopaedics, Department of Surgery, University of Western Ontario, London, Canada.""}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Nauth', 'Affiliation': ''}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Hall', 'Affiliation': ''}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Vicente', 'Affiliation': ''}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'McKee', 'Affiliation': ''}, {'ForeName': 'Emil H', 'Initials': 'EH', 'LastName': 'Schemitsch', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McKee', 'Affiliation': ''}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Hall', 'Affiliation': ''}, {'ForeName': 'G Midroni', 'Initials': 'GM', 'LastName': 'Milena Vicente', 'Affiliation': ''}, {'ForeName': 'Nauth', 'Initials': 'N', 'LastName': 'Aaron', 'Affiliation': ''}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Vicente', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hidy', 'Affiliation': ''}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'MacNevin', 'Affiliation': ''}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Foxall', 'Affiliation': ''}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Papp', 'Affiliation': ''}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Liew', 'Affiliation': ''}, {'ForeName': 'Wade', 'Initials': 'W', 'LastName': 'Gofton', 'Affiliation': ''}, {'ForeName': 'Karyn', 'Initials': 'K', 'LastName': 'Moon', 'Affiliation': ''}, {'ForeName': 'Raely', 'Initials': 'R', 'LastName': 'Moon', 'Affiliation': ''}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Moola', 'Affiliation': ''}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Perey', 'Affiliation': ''}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Apostle', 'Affiliation': ''}, {'ForeName': 'Darius', 'Initials': 'D', 'LastName': 'Viskontas', 'Affiliation': ''}, {'ForeName': 'H Michael', 'Initials': 'HM', 'LastName': 'Lemke', 'Affiliation': ''}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Stone', 'Affiliation': ''}, {'ForeName': 'Dory', 'Initials': 'D', 'LastName': 'Boyer', 'Affiliation': ''}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Kirkwood', 'Affiliation': ''}, {'ForeName': 'Tasha', 'Initials': 'T', 'LastName': 'Forbes', 'Affiliation': ''}, {'ForeName': 'Gene', 'Initials': 'G', 'LastName': 'Patterson', 'Affiliation': ''}, {'ForeName': 'Shaveen', 'Initials': 'S', 'LastName': 'Kullar', 'Affiliation': ''}, {'ForeName': 'Chaman Preet', 'Initials': 'CP', 'LastName': 'Singh Chahal', 'Affiliation': ''}, {'ForeName': 'Nigar', 'Initials': 'N', 'LastName': 'Sultana', 'Affiliation': ''}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Angeles', 'Affiliation': ''}, {'ForeName': 'Ted', 'Initials': 'T', 'LastName': 'Tufescu', 'Affiliation': ''}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Pilkey', 'Affiliation': ''}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Graham', 'Affiliation': ''}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hammond', 'Affiliation': ''}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Simunovic', 'Affiliation': ''}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Bzovsky', 'Affiliation': ''}, {'ForeName': 'Hiba', 'Initials': 'H', 'LastName': 'Mannan', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Crouch', 'Affiliation': ''}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lum', 'Affiliation': ''}, {'ForeName': 'Wesley', 'Initials': 'W', 'LastName': 'Ghent', 'Affiliation': ''}, {'ForeName': 'Fathima', 'Initials': 'F', 'LastName': 'Adamsahib', 'Affiliation': ''}, {'ForeName': 'Araby', 'Initials': 'A', 'LastName': 'Sivananthan', 'Affiliation': ''}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Nam', 'Affiliation': ''}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Axelrod', 'Affiliation': ''}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Axelrod', 'Affiliation': ''}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'MacDonald', 'Affiliation': ''}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Trask', 'Affiliation': ''}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Coles', 'Affiliation': ''}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Richardson', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Trenholm', 'Affiliation': ''}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Vicente', 'Affiliation': ''}, {'ForeName': 'Emil', 'Initials': 'E', 'LastName': 'Schemitsch', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McKee', 'Affiliation': ''}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Hall', 'Affiliation': ''}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Nauth', 'Affiliation': ''}, {'ForeName': 'Niloofar', 'Initials': 'N', 'LastName': 'Dehghan', 'Affiliation': ''}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Foxall', 'Affiliation': ''}, {'ForeName': 'Karyn', 'Initials': 'K', 'LastName': 'Moon', 'Affiliation': ''}, {'ForeName': 'Raely', 'Initials': 'R', 'LastName': 'Moon', 'Affiliation': ''}, {'ForeName': 'Mauri', 'Initials': 'M', 'LastName': 'Zomar', 'Affiliation': ''}, {'ForeName': 'Nigar', 'Initials': 'N', 'LastName': 'Sultana', 'Affiliation': ''}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Angeles', 'Affiliation': ''}, {'ForeName': 'Ted', 'Initials': 'T', 'LastName': 'Tufescu', 'Affiliation': ''}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Pilkey', 'Affiliation': ''}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Graham', 'Affiliation': ''}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Barron', 'Affiliation': ''}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hammond', 'Affiliation': ''}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Simunovic', 'Affiliation': ''}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Bzovsky', 'Affiliation': ''}, {'ForeName': 'Hiba', 'Initials': 'H', 'LastName': 'Mannan', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Crouch', 'Affiliation': ''}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lum', 'Affiliation': ''}, {'ForeName': 'Wesley', 'Initials': 'W', 'LastName': 'Ghent', 'Affiliation': ''}, {'ForeName': 'Fathima', 'Initials': 'F', 'LastName': 'Adamsahib', 'Affiliation': ''}, {'ForeName': 'Araby', 'Initials': 'A', 'LastName': 'Sivananthan', 'Affiliation': ''}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Kunz', 'Affiliation': ''}, {'ForeName': 'Elliott', 'Initials': 'E', 'LastName': 'Pally', 'Affiliation': ''}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'MacDonald', 'Affiliation': ''}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Trask', 'Affiliation': ''}, {'ForeName': 'Emil', 'Initials': 'E', 'LastName': 'Schemitsch', 'Affiliation': ''}, {'ForeName': 'Niloofar', 'Initials': 'N', 'LastName': 'Dehghan', 'Affiliation': ''}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Hall', 'Affiliation': ''}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Nauth', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McKee', 'Affiliation': ''}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Vicente', 'Affiliation': ''}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000002066'] 2379,33677430,The effect of peer support approach on communication skills of nursing students in pediatric clinical setting.,"Peer support is a valuable teaching-learning approach to enhance deep learning in the clinical environment. The purpose of the present study was to investigate the effect of peer support on the communication skills of undergraduate nursing students when interacting with hospitalized children and their parents. This was a pre-and post-test quasi-experimental study with two groups. Through the cluster random sampling method, six practical groups of students who undertook a 3-week pediatric practicum were selected. Three groups were allocated to the experimental (n = 51) and control groups (n = 52). Two volunteer post-graduate students in pediatric nursing formed the peer group. First, the peers participated in three 45-min sessions using different scenarios about communication skills. They then tutored the intervention group to improve their communication skills. The communication skills with 5 children and 5 parents were observed for each undergraduate student via the checklist. The experimental group demonstrated significantly higher mean scores of the communication skills than the control groups in post-test (P < 0.001). Moreover, the mean scores of communication skills was significantly higher in post-test than pre-test in both the experimental and control groups (p < 0.001). Peer support approach promoted the communication skills of undergraduate nursing students in pediatric clinical setting.",2021,The experimental group demonstrated significantly higher mean scores of the communication skills than the control groups in post-test (P < 0.001).,"['undergraduate nursing students when interacting with hospitalized children and their parents', 'Two volunteer post-graduate students in pediatric nursing formed the peer group', 'nursing students in pediatric clinical setting', 'undergraduate nursing students in pediatric clinical setting']","['peer support approach', 'peer support']","['mean scores of communication skills', 'mean scores of the communication skills']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0030753', 'cui_str': 'Nursing, Pediatric'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0030767', 'cui_str': 'Peer Group'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}]",5.0,0.0185718,The experimental group demonstrated significantly higher mean scores of the communication skills than the control groups in post-test (P < 0.001).,"[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Cheraghi', 'Affiliation': 'Department of Pediatric Nursing, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran. Electronic address: f_cheraghi@yahoo.com.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Hooshangian', 'Affiliation': 'Department of Pediatric Nursing, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Doosti-Irani', 'Affiliation': 'Department of Epidemiology, School of Public Health and Research Center for Health Sciences, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Khalili', 'Affiliation': 'Department of Pediatric Nursing, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran. Electronic address: arash5920@yahoo.com.'}]",Nurse education in practice,['10.1016/j.nepr.2021.102984'] 2380,33658092,Light therapy for seasonal affective disorder in visual impairment and blindness - a pilot study.,"OBJECTIVE Seasonal and non-seasonal depression are prevalent conditions in visual impairment (VI). We assessed the effects and side effects of light therapy in persons with severe VI/blindness who experienced recurrent depressive symptoms in winter corresponding to seasonal affective disorder (SAD) or subsyndromal SAD (sSAD). RESULTS We included 18 persons (11 with severe VI, 3 with light perception and 4 with no light perception) who met screening criteria for sSAD/SAD in a single-arm, assessor-blinded trial of 6 weeks light therapy. In the 12 persons who completed the 6 weeks of treatment, the post-treatment depression score was reduced (p < 0.001), and subjective wellbeing (p = 0.01) and sleep quality were improved (p = 0.03). In 6/12 participants (50%), the post-treatment depression score was below the cut-off set for remission. In four participants with VI, side effects (glare or transiently altered visual function) led to dropout or exclusion. CONCLUSION Light therapy was associated with a reduction in depressive symptoms in persons with severe VI/blindness. Eye safety remains a concern in persons with residual sight.",2021,"In the 12 persons who completed the 6 weeks of treatment, the post-treatment depression score was reduced (p < 0.001), and subjective wellbeing (p = 0.01) and sleep quality were improved (p = 0.03).","['persons with residual sight', 'persons with severe visual impairment/blindness', '18 persons (11 with severe visual impairment, 3 with light perception, 4 with no light perception) who met screening criteria for sSAD/SAD in a single-arm, assessor-blinded trial of 6 weeks light therapy', 'persons with severe visual impairment/blindness who had recurrent depressive symptoms in winter corresponding to seasonal affective disorder (SAD) or subsyndromal SAD (sSAD', '4 participants with visual impairment, side effects (glare or transiently altered visual function) led to drop-out or exclusion']","['light therapy', 'Light therapy']","['sleep quality', 'depressive symptoms', 'subjective wellbeing', 'post-treatment depression score']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C1301509', 'cui_str': 'Severe visual impairment'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0442774', 'cui_str': 'Visual acuity, no light perception'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0042798', 'cui_str': 'Dim vision'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0278215', 'cui_str': 'Glare'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}]","[{'cui': 'C0031765', 'cui_str': 'Light therapy'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",4.0,0.148923,"In the 12 persons who completed the 6 weeks of treatment, the post-treatment depression score was reduced (p < 0.001), and subjective wellbeing (p = 0.01) and sleep quality were improved (p = 0.03).","[{'ForeName': 'Helle Østergaard', 'Initials': 'HØ', 'LastName': 'Madsen', 'Affiliation': 'Mental Health Centre Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Shakoor', 'Initials': 'S', 'LastName': 'Ba-Ali', 'Affiliation': 'Department of Ophthalmology, Rigshospitalet-Glostrup Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Hageman', 'Affiliation': 'Mental Health Services, Capital Region of Denmark, Copenhagen, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Lund-Andersen', 'Affiliation': 'Department of Ophthalmology, Rigshospitalet-Glostrup Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Martiny', 'Affiliation': 'Mental Health Centre Copenhagen, Copenhagen, Denmark.'}]",Acta neuropsychiatrica,['10.1017/neu.2021.6'] 2381,33825030,Intraocular pressure responses to walking with surgical and FFP2/N95 face masks in primary open-angle glaucoma patients.,"PURPOSE The use of face mask is globally recommended as a preventive measure against COVID-19. However, the intraocular pressure (IOP) changes caused by face masks remain unknown. The objective of this study was to assess the impact of wearing surgical and FFP2/N95 face masks during a 400-m walking protocol on IOP in primary open-angle glaucoma (POAG) patients. METHODS Thirteen subjects diagnosed of POAG (21 eyes) were enrolled in this study. IOP was measured at baseline, during the 400-m walking protocol and after 5 min of passive recovery while POAG patients wore a surgical mask, FFP2/N95 mask and no mask in randomized order. From the 21 POAG eyes, we analyzed the IOP changes caused by physical exercise with two face masks and without wearing any face mask. RESULTS At rest (baseline and recovery measurements), the use of the different face masks did not affect IOP levels (mean differences ranging from 0.1 to 0.6 mmHg). During physical activity, wearing an FFP2/N95 mask caused a small (mean differences ranging from 1 to 2 mmHg), but statistically significant, IOP rise in comparison to both the surgical mask and control conditions (Cohen's d = 0.63 and 0.83, respectively). CONCLUSION Face masks must be used to minimize the risk of SARS-CoV-2 transmission, and POAG patients can safely use FFP2/N95 and surgical masks at rest. However, due to the IOP rise observed while walking with the FFP2/N95 mask, when possible, POAG patients should prioritized the use of surgical masks during physical activity.",2021,"At rest (baseline and recovery measurements), the use of the different face masks did not affect IOP levels (mean differences ranging from 0.1 to 0.6 mmHg).","['Thirteen subjects diagnosed of POAG (21 eyes', 'primary open-angle glaucoma (POAG) patients', 'primary open-angle glaucoma patients']","['wearing surgical and FFP2/N95 face masks', 'walking with surgical and FFP2/N95 face masks', 'surgical mask, FFP2/N95 mask and no mask']","['Intraocular pressure responses', 'intraocular pressure (IOP) changes', 'IOP changes', 'IOP levels', 'IOP rise', 'IOP']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0181758', 'cui_str': 'Surgical face mask'}]","[{'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035853', 'cui_str': 'Rose'}]",13.0,0.0310017,"At rest (baseline and recovery measurements), the use of the different face masks did not affect IOP levels (mean differences ranging from 0.1 to 0.6 mmHg).","[{'ForeName': 'Danica', 'Initials': 'D', 'LastName': 'Janicijevic', 'Affiliation': 'Research Academy of Human Biomechanics, The Affiliated Hospital of Medical School of Ningbo University, Ningbo University, Ningbo, China.'}, {'ForeName': 'Beatríz', 'Initials': 'B', 'LastName': 'Redondo', 'Affiliation': 'CLARO (Clinical and Laboratory Applications of Research in Optometry) Research Group, Department of Optics, Faculty of Sciences, University of Granada, Campus de la Fuentenueva 2, 18001, Granada, Spain. beatrizrc@ugr.es.'}, {'ForeName': 'Raimundo', 'Initials': 'R', 'LastName': 'Jiménez', 'Affiliation': 'CLARO (Clinical and Laboratory Applications of Research in Optometry) Research Group, Department of Optics, Faculty of Sciences, University of Granada, Campus de la Fuentenueva 2, 18001, Granada, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Lacorzana', 'Affiliation': 'Department of Ophthalmology, Virgen de las Nieves University Hospital, Granada, Spain.'}, {'ForeName': 'Amador', 'Initials': 'A', 'LastName': 'García-Ramos', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Vera', 'Affiliation': 'CLARO (Clinical and Laboratory Applications of Research in Optometry) Research Group, Department of Optics, Faculty of Sciences, University of Granada, Campus de la Fuentenueva 2, 18001, Granada, Spain.'}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-021-05159-3'] 2382,33665769,Serum Biomarkers of Regeneration and Plasticity are Associated with Functional Outcome in Pediatric Neurocritical Illness: An Exploratory Study.,"BACKGROUND/OBJECTIVE Pediatric neurocritical care survivorship is frequently accompanied by functional impairments. Lack of prognostic biomarkers is a barrier to early identification and management of impairment. We explored the association between blood biomarkers and functional impairment in children with acute acquired brain injury. METHODS This study is a secondary analysis of a randomized control trial evaluating early versus usual care rehabilitation in the pediatric intensive care unit (PICU). Forty-four children (17 [39%] female, median age 11 [interquartile range 6-13] years) with acute acquired brain injury admitted to the PICU were studied. A single center obtained serum samples on admission days 0, 1, 3, 5, and the day closest to hospital discharge. Biomarkers relevant to brain injury (neuron specific enolase [NSE], S100b), inflammation (interleukin [IL-6], C-reactive protein), and regeneration (brain-derived neurotrophic factor [BDNF], vascular endothelial growth factor [VEGF]) were collected. Biomarkers were analyzed using a Luminex® bioassay. Functional status scale (FSS) scores were abstracted from the medical record. New functional impairment was defined as a (worse) FSS score at hospital discharge compared to pre-PICU (baseline). Individual biomarker fluorescence index (FI) values for each sample collection day were correlated with new functional impairment using Spearman rank correlation coefficient (ρ). Trends in repeated measures of biomarker FI over time were explored graphically, and the association between repeated measures of biomarker FI and new functional impairment was analyzed using covariate adjusted linear mixed-effect models. RESULTS Functional impairment was inversely correlated with markers of regeneration and plasticity including BDNF at day 3 (ρ =  - 0.404, p = .015), day 5 (ρ =  - 0.549, p = 0.005) and hospital discharge (ρ =  - 0.420, p = 0.026) and VEGF at day 1 (ρ =  - 0.282, p = 0.008) and hospital discharge (ρ =  - 0.378, p = 0.047), such that lower levels of both markers at each time point were associated with greater impairment. Similarly, repeated measures of BDNF and VEGF were inversely correlated with new functional impairment (B =  - 0.001, p = 0.001 and B =  - 0.001, p = 0.003, respectively). NSE, a biomarker of acute brain injury, showed a positive correlation between day 0 levels and new functional impairment (ρ = 0.320, p = 0.044). CONCLUSIONS Blood-based biomarkers of regeneration and plasticity may hold prognostic utility for functional impairment among pediatric patients with neurocritical illness and warrant further investigation.",2021,"Similarly, repeated measures of BDNF and VEGF were inversely correlated with new functional impairment (B =  - 0.001, p = 0.001 and B =  - 0.001, p = 0.003, respectively).","['children with acute acquired brain injury', 'Forty-four children (17 [39%] female, median age 11 [interquartile range 6-13] years) with acute acquired brain injury admitted to the PICU were studied', 'Pediatric Neurocritical Illness', 'pediatric intensive care unit (PICU', 'pediatric patients with neurocritical illness']",['usual care rehabilitation'],"['hospital discharge', 'Functional status scale (FSS) scores', 'VEGF', 'BDNF and VEGF', 'brain injury (neuron specific enolase [NSE], S100b), inflammation (interleukin [IL-6], C-reactive protein), and regeneration (brain-derived neurotrophic factor [BDNF], vascular endothelial growth factor [VEGF', 'new functional impairment', 'biomarker FI and new functional impairment', 'Individual biomarker fluorescence index (FI) values', 'markers of regeneration and plasticity including BDNF']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0202144', 'cui_str': 'Neuron-specific enolase measurement'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0034963', 'cui_str': 'Regeneration'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0678558', 'cui_str': 'Plasticity'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",44.0,0.0464905,"Similarly, repeated measures of BDNF and VEGF were inversely correlated with new functional impairment (B =  - 0.001, p = 0.001 and B =  - 0.001, p = 0.003, respectively).","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Madurski', 'Affiliation': ""Department of Critical Care Medicine, UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA, USA.""}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Jarvis', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Sue R', 'Initials': 'SR', 'LastName': 'Beers', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Houtrow', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Amy K', 'Initials': 'AK', 'LastName': 'Wagner', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Fabio', 'Affiliation': 'Epidemiology Data Center, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Epidemiology Data Center, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Craig M', 'Initials': 'CM', 'LastName': 'Smith', 'Affiliation': ""Division of Critical Care, Department of Pediatrics, Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA.""}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Doughty', 'Affiliation': ""Division of Critical Care Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Keri', 'Initials': 'K', 'LastName': 'Janesko-Feldman', 'Affiliation': ""Department of Critical Care Medicine, UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA, USA.""}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Rubin', 'Affiliation': ""Department of Critical Care Medicine, UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA, USA.""}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Pollon', 'Affiliation': 'Special Needs Child Advocate and Study Stakeholder, Pittsburgh, PA, USA.'}, {'ForeName': 'Amery', 'Initials': 'A', 'LastName': 'Treble-Barna', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Kochanek', 'Affiliation': ""Department of Critical Care Medicine, UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA, USA.""}, {'ForeName': 'Ericka L', 'Initials': 'EL', 'LastName': 'Fink', 'Affiliation': ""Department of Critical Care Medicine, UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA, USA. finkel@ccm.upmc.edu.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurocritical care,['10.1007/s12028-021-01199-z'] 2383,33665714,ASO Visual Abstract: Laparoscopic R1 Vascular Hepatectomy for Hepatocellular Carcinoma (With Video).,,2021,,['Hepatocellular Carcinoma (With Video'],['ASO Visual Abstract: Laparoscopic R1 Vascular Hepatectomy'],[],"[{'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0003436', 'cui_str': 'Antistreptolysin O'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0000857', 'cui_str': 'Abstracting as Topic'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}]",[],,0.0381914,,"[{'ForeName': 'Annarita', 'Initials': 'A', 'LastName': 'Libia', 'Affiliation': 'Department of Surgical Science, University of Rome ""Sapienza"", Rome, Italy. libiamd@me.com.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Ferraro', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Surgery, Ecclesiastical Entity General Regional Hospital F. Miulli, Acquaviva delle Fonti, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Tedeschi', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Surgery, Ecclesiastical Entity General Regional Hospital F. Miulli, Acquaviva delle Fonti, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': ""de'Angelis"", 'Affiliation': 'Minimal Invasive and Robotic Gastrointestinal Surgery, Ecclesiastical Entity General Regional Hospital F. Miulli, Acquaviva delle Fonti, Italy.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Torzilli', 'Affiliation': 'Department of Surgery, Division of Hepatobiliary and General Surgery, Humanitas Clinical and Research Center, Humanitas University, Milan, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Aldrighetti', 'Affiliation': 'Department of Surgery-Liver Unit, Scientific Institute San Raffaele, Milan, Italy.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Pessaux', 'Affiliation': 'Hepatobiliary Surgery and Transplantation, Hautepierre Hospital, Strasbourg, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Cherqui', 'Affiliation': 'Centre Hepato-Biliaire, AP-HP Hopital Paul Brousse, Villejuif, France.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Memeo', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Surgery, Ecclesiastical Entity General Regional Hospital F. Miulli, Acquaviva delle Fonti, Italy.'}]",Annals of surgical oncology,['10.1245/s10434-021-09758-6'] 2384,33662894,"Efficacy of adjunctive cenobamate based on number of concomitant antiseizure medications, seizure frequency, and epilepsy duration at baseline: A post-hoc analysis of a randomized clinical study.","BACKGROUND In an 18-week, double-blind, placebo-controlled study (YKP3089C017; NCT01866111), cenobamate was effective for the treatment of focal-onset seizures. This post-hoc analysis examined the effects of baseline clinical features on the efficacy of adjunctive cenobamate during the study. METHODS Adults with uncontrolled focal seizures despite treatment with 1-3 antiepileptic drugs/antiseizure medications (AEDs/ASMs) were randomized 1:1:1:1 to placebo or cenobamate 100, 200, or 400 mg once daily. Median percent seizure frequency reduction/28 days and ≥50% responder rates were assessed during the 12-week maintenance phase (n = 397) by number of baseline (concomitant) ASMs (1, 2, >2), median baseline seizure frequency/28 days (≤9.5 vs >9.5), and median baseline duration of epilepsy (≤23 vs >23 years). RESULTS For patients taking 1 concomitant ASM, median percent seizure frequency reductions ranged from 44.7% to 86.0% for cenobamate-treated patients vs 24.1% for placebo; for 2 concomitant ASMs, reductions were 41.4-57.9% with cenobamate vs 33.3% for placebo; and for >2 concomitant ASMs, reductions were 41.5-67.4% with cenobamate vs 26.4% for placebo. The highest reductions occurred in the 200- and 400-mg/day cenobamate groups. For patients with baseline seizure frequency ≤9.5, the greatest reduction in median percent seizure frequency occurred in the 200-mg/day cenobamate group (66.5%); for patients with baseline seizure frequency >9.5 the greatest reduction occurred in the 400-mg/day cenobamate group (70.7%). Similar improvements were observed when assessed by median duration of epilepsy at baseline. For cenobamate-treated patients taking 1, 2, or >2 ASMs respectively, ≥50% responder rates of up to 66.7% (400 mg), 62.2% (200 mg), and 66.0% (400 mg) were observed, vs 20.0%, 29.3%, and 23.9% for placebo, respectively; 100% seizure reductions were observed in up to 25.0% (400 mg/day), 22.2% (400 mg/day), and 19.1% (400 mg/day) of cenobamate-treated patients, vs 0%, 0%, and 2.2% for placebo, respectively. Incidence of common (≥10%) central nervous system adverse events (dizziness, somnolence, fatigue, and diplopia) were highest in the >2 ASM group, but the rates were within the range reported in the primary study. CONCLUSIONS Clinically relevant reductions in seizure frequency including 100% seizure reductions occurred with adjunctive cenobamate regardless of number of concomitant ASMs, baseline seizure frequency, or disease duration. The greatest reductions occurred in the 200- and 400-mg/day groups.",2021,"CONCLUSIONS Clinically relevant reductions in seizure frequency including 100% seizure reductions occurred with adjunctive cenobamate regardless of number of concomitant ASMs, baseline seizure frequency, or disease duration.",['Adults with uncontrolled focal seizures despite treatment with 1-3 antiepileptic drugs/antiseizure medications (AEDs/ASMs'],"['placebo or cenobamate', 'adjunctive cenobamate', 'placebo']","['median baseline duration of epilepsy', 'seizure frequency reductions', 'median duration of epilepsy', 'highest reductions', 'median percent seizure frequency', 'seizure reductions', 'Incidence of common (≥10%) central nervous system adverse events (dizziness, somnolence, fatigue, and diplopia', 'number of concomitant antiseizure medications, seizure frequency, and epilepsy duration']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0012569', 'cui_str': 'Diplopia'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",,0.576846,"CONCLUSIONS Clinically relevant reductions in seizure frequency including 100% seizure reductions occurred with adjunctive cenobamate regardless of number of concomitant ASMs, baseline seizure frequency, or disease duration.","[{'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Rosenfeld', 'Affiliation': 'Comprehensive Epilepsy Care Center for Children and Adults, 11134 Conway Road, 63131 St. Louis, MO, USA. Electronic address: werosenfeldmd@gmail.com.'}, {'ForeName': 'Arkady', 'Initials': 'A', 'LastName': 'Nisman', 'Affiliation': 'SK Life Science, Inc., Paramus, NJ, USA.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Ferrari', 'Affiliation': 'SK Life Science, Inc., Paramus, NJ, USA.'}]",Epilepsy research,['10.1016/j.eplepsyres.2021.106592'] 2385,33662760,The elderly's physiological and perceptual responses to cooling during simulated activities of daily living in UK summer climatic conditions.,"OBJECTIVES The elderly are the most at-risk population for heat-related illness and mortality during the periods of hot weather. However, evidence-based elderly-specific cooling strategies to prevent heat-illness are limited. The aim of this investigation was to quantify the elderly's physiological and perceptual responses to cooling through cold water ingestion (COLD) or an L-menthol mouth rinse (MENT) during simulated activities of daily living in UK summer climatic conditions. STUDY DESIGN Randomised, controlled repeated measures research design. METHODS A total of ten participants (men n = 7, women n = 3: age; 69 ± 3 yrs, height; 168 ± 10 cm, body mass; 68.88 ± 13.72 kg) completed one preliminary and three experimental trials; control (CON), COLD and MENT. Experimental trials consisted of 40 min rest followed by 30 min of cycling exercise at 6 metabolic equivalents and a 6-min walk test (6MWT), within a 35 °C, 50% relative humidity environment. Experimental interventions (every 10 min); cold water (4 °C) ingestion (total of 1.5L) or menthol (5 ml mouth swill for 5 s, menthol concentration of 0.01%). RESULTS Peak rectal temperature (T re ) was significantly (P < 0.05) lower in COLD compared with CON (-0.34 ± 0.16 °C) and MENT (-0.36 ± 0.20 °C). End exercise heart rate (HR) decreased in COLD compared with CON (-7 ± 9 b min -1 ) and MENT (-6 ± 7 b min -1 ). There was no difference in end exercise thermal sensation (TS) (CON; 6.1 ± 0.4, COLD; 6.0 ± 0.4, MENT; 6.4 ± 0.6) or thermal comfort (TC) (CON; 4 ± 1, COLD; 4 ± 1, MENT; 4 ± 1) between trials. The participants walked significantly further during the COLD 6MWT compared with CON (40 m ± 40 m) and MENT (40 m ± 30 m). There was reduced physiological strain in the COLD 6MWT compared with CON (T re ; -0.21 ± 0.24 °C, HR; -7 ± 8 b min -1 ) and MENT (T re ; -0.23 ± 0.24 °C, HR; -4 ± 7 b min -1 ). CONCLUSION The elderly have reduced physiological strain (T re and HR) during activities of daily living and a 6MWT in hot UK climatic conditions, when they drink cold water. Furthermore, the elderly's perception (TS and TC) of the hot environment did not differ from CON at the end of exercise with COLD or MENT interventions. Menthol provided neither perceptual benefit to exercise in the heat nor functional gain. The TS data indicate that elderly may be at increased risk of heat illness, due to not feeling hot and uncomfortable enough to implement physiological strain reducing strategies such as cold-water ingestion.",2021,"RESULTS Peak rectal temperature (T re ) was significantly (P < 0.05) lower in COLD compared with CON (-0.34 ± 0.16 °C) and MENT (-0.36 ± 0.20 ","['A total of ten participants (men n\xa0=\xa07, women n\xa0=\xa03: age; 69\xa0±\xa03\xa0yrs, height; 168\xa0±\xa010\xa0cm, body mass; 68.88\xa0±\xa013.72\xa0kg) completed one preliminary and three experimental trials', 'daily living in UK summer climatic conditions']","['40\xa0min rest followed by 30\xa0min of cycling exercise at 6 metabolic equivalents and a 6-min walk test (6MWT', 'cooling through cold water ingestion (COLD) or an L-menthol mouth rinse (MENT', 'Experimental interventions (every 10\xa0min); cold water (4\xa0°C) ingestion (total of 1.5L) or menthol', 'Menthol', 'CON', 'control (CON), COLD and MENT', 'CON (-7\xa0±']","['Peak rectal temperature (T re ', 'end exercise thermal sensation (TS', 'End exercise heart rate (HR', 'physiological strain']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2355577', 'cui_str': 'Metabolic Equivalent'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C4708833', 'cui_str': 'Cold water'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0771655', 'cui_str': 'LEVOMENTHOL'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0084844', 'cui_str': 'trestolone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0489749', 'cui_str': 'Rectal temperature'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0039478', 'cui_str': 'Thermal sensation, function'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}]",10.0,0.120661,"RESULTS Peak rectal temperature (T re ) was significantly (P < 0.05) lower in COLD compared with CON (-0.34 ± 0.16 °C) and MENT (-0.36 ± 0.20 ","[{'ForeName': 'K A M', 'Initials': 'KAM', 'LastName': 'Waldock', 'Affiliation': 'Army Health and Performance Research, Andover, United Kingdom; Environmental Extremes Laboratory, University of Brighton, Eastbourne, United Kingdom. Electronic address: kirsty.waldock100@mod.gov.uk.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hayes', 'Affiliation': 'Environmental Extremes Laboratory, University of Brighton, Eastbourne, United Kingdom.'}, {'ForeName': 'P W', 'Initials': 'PW', 'LastName': 'Watt', 'Affiliation': 'Environmental Extremes Laboratory, University of Brighton, Eastbourne, United Kingdom.'}, {'ForeName': 'N S', 'Initials': 'NS', 'LastName': 'Maxwell', 'Affiliation': 'Environmental Extremes Laboratory, University of Brighton, Eastbourne, United Kingdom.'}]",Public health,['10.1016/j.puhe.2021.01.016'] 2386,33358848,Editorial: The Vanishing Value of Evidence-based Treatments: Is Our Mental Health Expertise Irrelevant?,"The article in this issue of JAACAP by the CAMELS (Child/Adolescent Anxiety Multimodal Extended Long-term Study) study team, Peris et al. 1 , offers 2 very important contributions. Conveniently, the first contribution is also the stated purpose of this report: to present findings detailing the extent to which children and adolescents who previously participated (averaging 6.5 years previously) in the landmark Child and Adolescent Multimodal Study of Anxiety (CAMS) multisite randomized controlled trial (RCT) 2 did or did not receive follow-up services. This is not a good-news story. By and large, over the 6-year follow-up, only 35% of the previous RCT-treated children and youth received ""consistent"" continuing services, either through medication or cognitive-behavioral therapy (CBT), despite ongoing issues of anxiety and significant impairment.",2021,"By and large, over the 6-year follow-up, only 35% of the previous RCT-treated children and youth received ""consistent"" continuing services, either through medication or cognitive-behavioral therapy (CBT), despite ongoing issues of anxiety and significant impairment.","['children and adolescents who previously participated (averaging 6.5 years previously) in the landmark Child and Adolescent Multimodal Study of Anxiety (CAMS', 'Editorial']","['cognitive-behavioral therapy (CBT', 'JAACAP']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0282412', 'cui_str': 'Editorial'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",[],,0.0248867,"By and large, over the 6-year follow-up, only 35% of the previous RCT-treated children and youth received ""consistent"" continuing services, either through medication or cognitive-behavioral therapy (CBT), despite ongoing issues of anxiety and significant impairment.","[{'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Jensen', 'Affiliation': 'The REACH Institute, New York, and the University of Arkansas for Medical Sciences, Little Rock. Electronic address: PeterJensen@TheReachInstitute.org.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2020.12.021'] 2387,33667497,Changes in food intake during the COVID-19 pandemic in New York City.,"The COVID-19 pandemic and stay-at-home orders across the nation have had substantial consequences on access to food and dietary behaviors. We investigated the dietary intake of adults in NYC, before and during the COVID-19 period. A subset of participants (n = 31) from an NIH-funded multi-level discount supermarket study were assessed. In this study, the experimental groups received a 0% (control), 15%, or 30% discount on fruits, vegetables, and noncaloric beverages for 8 months. The discount level for the participants who were selected for this study did not change from the pre-COVID to during COVID periods. Dietary intake data was collected using three unannounced 24-h dietary recalls (2 weekdays, 1 weekend) during each period. Changes in total daily kcal of food and beverages, total g of solid food, energy density of solid food (kcal/g), and g of fruit and vegetables, soda, non-caloric beverages, and snack foods were analyzed using multivariate linear regression. Energy density (ED) increased during COVID (+0.02 ± 0.5 [SD], F[4,26] = 3.0, p = 0.038). There was an interaction by gender (t = -3.2, p = 0.0035) such that ED increased for females (+0.27 ± 0.46, p = 0.037) and decreased for males (-0.22 ± 0.32, p = 0.012). The change in ED is likely due to the circumstances surrounding COVID-19, e.g. being at home, stress, and food shortages.",2021,"Energy density (ED) increased during COVID (+0.02 ± 0.5 [SD], F[4,26] = 3.0, p = 0.038).",['A subset of participants (n = 31) from an NIH-funded multi-level supermarket study were assessed'],[],"['Food Intake', 'total daily kcal of food and beverages, total g of solid food, energy density of solid food (kcal/g), and g of fruit and vegetables, soda, non-caloric beverages, and snack foods', 'Energy density (ED']","[{'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0557778', 'cui_str': 'Supermarket'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0524819', 'cui_str': 'Foods and drinks'}, {'cui': 'C0453855', 'cui_str': 'Solid food'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0683086', 'cui_str': 'Caffeinated soft drinks'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}]",31.0,0.0524785,"Energy density (ED) increased during COVID (+0.02 ± 0.5 [SD], F[4,26] = 3.0, p = 0.038).","[{'ForeName': 'Atene S', 'Initials': 'AS', 'LastName': 'Poskute', 'Affiliation': 'Department of Psychiatry Icahn School of Medicine at Mount Sinai New York, NY, USA. Electronic address: atene.poskute@mountsinai.org.'}, {'ForeName': 'Aniema', 'Initials': 'A', 'LastName': 'Nzesi', 'Affiliation': 'Department of Psychiatry Icahn School of Medicine at Mount Sinai New York, NY, USA.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Geliebter', 'Affiliation': 'Department of Psychiatry Icahn School of Medicine at Mount Sinai New York, NY, USA.'}]",Appetite,['10.1016/j.appet.2021.105191'] 2388,33671093,Low Energy Availability with and without a High-Protein Diet Suppresses Bone Formation and Increases Bone Resorption in Men: A Randomized Controlled Pilot Study.,"Suppression of insulin-like growth factor 1 (IGF-1) and leptin secondary to low energy availability (LEA) may contribute to adverse effects on bone health. Whether a high-protein diet attenuates these effects has not been tested. Seven men completed three five-day conditions operationally defined as LEA (15 kcal kg fat-free mass (FFM) -1 day -1 ) with low protein (LEA-LP; 0.8 g protein·kg body weight (BW) -1 ), LEA with high protein (LEA-HP; 1.7 g protein·kg BW -1 ) and control (CON; 40 kcal·kg FFM -1 ·day -1 , 1.7 g protein·kg BW -1 ). In all conditions, participants expended 15 kcal·kg FFM -1 ·day -1 during supervised cycling sessions. Serum samples were analyzed for markers of bone turnover, IGF-1 and leptin. The decrease in leptin during LEA-LP (-65.6 ± 4.3%) and LEA-HP (-54.3 ± 16.7%) was greater than during CON (-25.4 ± 11.4%; p = 0.02). Decreases in P1NP ( p = 0.04) and increases in CTX-I ( p = 0.04) were greater in LEA than in CON, suggesting that LEA shifted bone turnover in favour of bone resorption. No differences were found between LEA-LP and LEA-HP. Thus, five days of LEA disrupted bone turnover, but these changes were not attenuated by a high-protein diet.",2021,"Decreases in P1NP ( p = 0.04) and increases in CTX-I ( p = 0.04) were greater in LEA than in CON, suggesting that LEA shifted bone turnover in favour of bone resorption.",['Men'],"['LEA', 'Low Energy Availability with and without a High-Protein Diet']","['LEA-HP', 'CTX-I', 'Bone Resorption', 'bone turnover', 'P1NP', 'leptin during LEA-LP']","[{'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0425403', 'cui_str': 'Increased protein diet'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0299583', 'cui_str': 'leptin'}]",,0.0206593,"Decreases in P1NP ( p = 0.04) and increases in CTX-I ( p = 0.04) were greater in LEA than in CON, suggesting that LEA shifted bone turnover in favour of bone resorption.","[{'ForeName': 'Chaise', 'Initials': 'C', 'LastName': 'Murphy', 'Affiliation': 'Department of Nutrition and Health Sciences, University of Nebraska-Lincoln, Lincoln, NE 68503, USA.'}, {'ForeName': 'Laura D D', 'Initials': 'LDD', 'LastName': 'Bilek', 'Affiliation': 'College of Allied Health Professionals, University of Nebraska Medical Center, Omaha, NE 68198, USA.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Koehler', 'Affiliation': 'Department of Nutrition and Health Sciences, University of Nebraska-Lincoln, Lincoln, NE 68503, USA.'}]",Nutrients,['10.3390/nu13030802'] 2389,32961062,Effect of local cold application during exercise on gene expression related to mitochondrial homeostasis.,"Exercise training increases mitochondrial content in active skeletal muscle. Previous work suggests that mitochondrial-related genes respond favorably to exercise in cold environments. However, the impact of localized tissue cooling is unknown. The purpose of this study was to determine the impact of local muscle cooling during endurance exercise on human skeletal muscle mitochondrial-related gene expression. Twelve subjects (age, 28 ± 6 years) cycled at 65% peak power output. One leg was cooled (C) for 30 min before and during exercise with a thermal wrap while the other leg was wrapped but not cooled, room temperature (RT). Muscle biopsies were taken from each vastus lateralis before and 4 h after exercise for the analysis of gene expression. Muscle temperature was lower in the C (29.2 ± 0.7 °C) than the RT (34.1 ± 0.3 °C) condition after pre-cooling for 30 min before exercise ( p < 0.001) and remained lower after exercise in the C (36.9 ± 0.5) than the RT (38.4 ± 0.2, p < 0.001) condition. PGC-1α and NRF1 mRNA expression were lower in the C ( p = 0.012 and p = 0.045, respectively) than the RT condition at 4 h after exercise. There were no temperature-related differences in other genes ( p > 0.05). These data suggest that local cooling has an inhibitory effect on exercise-induced PGC-1α and NRF1 expression in human skeletal muscle. Those considering using local cooling during exercise should consider other systemic cooling options. Novelty: Local cooling has an inhibitory effect on exercise-induced PGC-1α and NRF1 expression in human skeletal muscle. Local cooling may lead to a less robust exercise stimulus compared with standard conditions.",2021,"PGC-1α and NRF1 mRNA expression were lower in the C ( p = 0.012 and p = 0.045, respectively) than the RT condition at 4 h after exercise.","['active skeletal muscle', 'Twelve subjects (age, 28 ± 6 years) cycled at 65% peak power output']","['local cold application', 'endurance exercise', 'Exercise training']","['Muscle temperature', 'PGC-1α and NRF1 mRNA expression']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0445194', 'cui_str': 'Power output'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",,0.0434269,"PGC-1α and NRF1 mRNA expression were lower in the C ( p = 0.012 and p = 0.045, respectively) than the RT condition at 4 h after exercise.","[{'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Meister', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska at Omaha, Omaha, NE 68182, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Collins', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska at Omaha, Omaha, NE 68182, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'McGlynn', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska at Omaha, Omaha, NE 68182, USA.'}, {'ForeName': 'Dustin', 'Initials': 'D', 'LastName': 'Slivka', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska at Omaha, Omaha, NE 68182, USA.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2020-0387'] 2390,33675935,Effect of Reiki on the stress level of caregivers of patients with cancer: Qualitative and single-blind randomized controlled trial.,"OBJECTIVE This study aimed to evaluate the effect of Reiki on stress levels of individuals caring for patients with cancer. METHODS The study was conducted a pretest-posttest, single-blind randomized controlled trial and qualitative study using a semi-structured in-depth interview. In this study, women who were primary caregivers of patients with cancer treated in a university hospital were randomized to Reiki and sham Reiki groups. The Reiki group received Reiki to nine main points for 45 min, once a week for 6 weeks, while the sham Reiki group received the same points during the same period without starting energy flow. CSI scores and salivary cortisol levels were evaluated at baseline and at the end of the study, whereas systolic and diastolic blood pressure and pulse rate were evaluated before and after application every week. After the study, the opinions of the Reiki group on Reiki experience were collected by using a questionnaire consisting of semi-structured questions. RESULTS The study was completed with a total of 42 caregivers. The sample size was calculated based on the difference in Caregiver Strain Index (CSI) scores before and after the intervention. According to the power analysis, with α = 0.05 and β = 0.20, the effect size was 1.71 and the power 99 %. Post-intervention CSI scores declined in the Reiki group compared with that in the sham Reiki group (p < 0.05). No significant difference was found between the groups in terms of saliva cortisol levels (p > 0.05). According to the results of the general linear model repeated measure and Friedman tests, which were conducted to evaluate the change in systolic and diastolic blood pressure and pulse rate over a 6-week period, the values of these parameters decreased before and after each application compared with the caregivers in the sham Reiki group (p < 0.05). All caregivers stated that they found the caring process less stressful after the Reiki sessions and felt relieved compared with the pre-therapy period, and some of their physical complaints decreased. CONCLUSION Reiki reduces the stress levels of caregivers, is effective in regulating blood pressure and pulse rate, does not cause a significant change on saliva cortisol level, and provides relief to caregivers.",2021,"Reiki reduces the stress levels of caregivers, is effective in regulating blood pressure and pulse rate, does not cause a significant change on saliva cortisol level, and provides relief to caregivers.","['Caregivers of Patients with Cancer', '42 women who were primary caregivers of patients with cancer treated in a university hospital', 'individuals caring for patients with cancer']",['Reiki'],"['systolic and diastolic blood pressure and pulse rate', 'blood pressure and pulse rate', 'saliva cortisol level', 'saliva cortisol levels', 'Caregiver Strain Index (CSI) scores', 'CSI scores and salivary cortisol levels', 'intervention CSI scores', 'change in systolic and diastolic blood pressure and pulse rate', 'Reiki experience']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1319883', 'cui_str': 'Primary caregiver'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0751715', 'cui_str': 'Reiki'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0751715', 'cui_str': 'Reiki'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",42.0,0.0518608,"Reiki reduces the stress levels of caregivers, is effective in regulating blood pressure and pulse rate, does not cause a significant change on saliva cortisol level, and provides relief to caregivers.","[{'ForeName': 'Ulviye', 'Initials': 'U', 'LastName': 'Özcan Yüce', 'Affiliation': 'Health Sciences Faculty, Nursing Department, Osmaniye Korkut Ata University, Osmaniye, Turkey. Electronic address: ulviyeyuce@osmaniye.edu.tr.'}, {'ForeName': 'Sultan', 'Initials': 'S', 'LastName': 'Taşcı', 'Affiliation': 'Health Sciences Faculty, Department of Internal Nursing, Erciyes University, Kayseri, Turkey. Electronic address: sultant@erciyes.edu.tr.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2021.102708'] 2391,33675695,Emergency Department Interventions for Frailty (EDIFY): Front-Door Geriatric Care Can Reduce Acute Admissions.,"OBJECTIVES The EDIFY program was developed to deliver early geriatric specialist interventions at the emergency department (ED) to reduce the number of acute admissions by identifying patients for safe discharge or transfer to low-acuity care settings. We evaluated the effectiveness of EDIFY in reducing potentially avoidable acute admissions. DESIGN A quasi-experimental study. SETTING ED of a 1700-bed tertiary hospital. PARTICIPANTS ED patients aged ≥85 years. MEASUREMENTS We compared EDIFY interventions versus standard care. Patients with plans for acute admission were screened and recruited. Data on demographics, premorbid function, frailty status, comorbidities, and acute illness severity were gathered. We examined the primary outcome of ""successful acute admission avoidance"" among the intervention group, which was defined as no ED attendance within 72 hours of discharge from ED, no transfer to an acute ward from subacute-care units (SCU) within 72-hours, or no transfer to an acute ward from the short-stay unit (SSU). Secondary outcomes were rehospitalization, ED re-attendance, institutionalization, functional decline, mortality, and frailty transitions at 1, 3, and 6 months. RESULTS We recruited 100 participants (mean age 90.0 ± 4.1 years, 66.0% women). There were no differences in baseline characteristics between intervention (n = 43) and nonintervention (n = 57) groups. Thirty-five (81.4%) participants in the intervention group successfully avoided an acute admission (20.9% home, 23.3% SCU, and 44.2% SSU). All participants in the nonintervention group were hospitalized. There were no differences in rehospitalization, ED re-attendance, institutionalization and mortality over the study period. Additionally, we observed a higher rate of progression to a poorer frailty category at all time points among the nonintervention group (1, 3, and 6 months: all P < .05). CONCLUSIONS AND IMPLICATIONS Results from our single-center study suggest that early geriatric specialist interventions at the ED can reduce potentially avoidable acute admissions without escalating the risk of rehospitalization, ED re-attendance, or mortality, and with possible benefit in attenuating frailty progression.",2021,There were no differences in baseline characteristics between intervention (n = 43) and nonintervention (n = 57) groups.,"['Patients with plans for acute admission were screened and recruited', 'within 72\xa0hours of discharge from ED, no transfer to an acute ward from subacute-care units (SCU) within 72-hours, or no transfer to an acute ward from the short-stay unit (SSU', 'ED patients aged ≥85\xa0years', 'ED of a 1700-bed tertiary hospital', '100 participants (mean age 90.0\xa0±\xa04.1\xa0years, 66.0% women']",['EDIFY'],"['rehospitalization, ED re-attendance, institutionalization and mortality', 'rehospitalization, ED re-attendance, institutionalization, functional decline, mortality, and frailty transitions at 1, 3, and 6\xa0months', 'successful acute admission avoidance', 'demographics, premorbid function, frailty status, comorbidities, and acute illness severity', 'acute admission', 'rate of progression to a poorer frailty category', 'no ED attendance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0376635', 'cui_str': 'Postacute Care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0021629', 'cui_str': 'Institutionalization'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]",100.0,0.0622834,There were no differences in baseline characteristics between intervention (n = 43) and nonintervention (n = 57) groups.,"[{'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Chong', 'Affiliation': 'Department of Geriatric Medicine, Tan Tock Seng Hospital (TTSH), Singapore; Institute of Geriatrics and Active Ageing (IGA), TTSH, Singapore. Electronic address: edward_chong@ttsh.com.sg.'}, {'ForeName': 'Birong', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': 'Department of Nursing Services, TTSH, Singapore.'}, {'ForeName': 'Hongyun', 'Initials': 'H', 'LastName': 'Tan', 'Affiliation': 'Department of Nursing Services, Woodlands Health Campus, Singapore.'}, {'ForeName': 'Joseph De Castro', 'Initials': 'JC', 'LastName': 'Molina', 'Affiliation': 'Health Services and Outcomes Research (HSOR), National Healthcare Group, Singapore.'}, {'ForeName': 'Eileen Fabia', 'Initials': 'EF', 'LastName': 'Goh', 'Affiliation': 'Institute of Geriatrics and Active Ageing (IGA), TTSH, Singapore.'}, {'ForeName': 'Jewel', 'Initials': 'J', 'LastName': 'Baldevarona-Llego', 'Affiliation': 'Department of Geriatric Medicine, Tan Tock Seng Hospital (TTSH), Singapore.'}, {'ForeName': 'Jia Qian', 'Initials': 'JQ', 'LastName': 'Chia', 'Affiliation': 'Department of Geriatric Medicine, Tan Tock Seng Hospital (TTSH), Singapore.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Chong', 'Affiliation': 'Department of Geriatric Medicine, Tan Tock Seng Hospital (TTSH), Singapore.'}, {'ForeName': 'Selina', 'Initials': 'S', 'LastName': 'Cheong', 'Affiliation': 'Department of Pharmacy, TTSH, Singapore.'}, {'ForeName': 'Palvinder', 'Initials': 'P', 'LastName': 'Kaur', 'Affiliation': 'Health Services and Outcomes Research (HSOR), National Healthcare Group, Singapore.'}, {'ForeName': 'Michelle Jessica', 'Initials': 'MJ', 'LastName': 'Pereira', 'Affiliation': 'Health Services and Outcomes Research (HSOR), National Healthcare Group, Singapore.'}, {'ForeName': 'Sheryl Hui Xian', 'Initials': 'SHX', 'LastName': 'Ng', 'Affiliation': 'Health Services and Outcomes Research (HSOR), National Healthcare Group, Singapore.'}, {'ForeName': 'Chik Loon', 'Initials': 'CL', 'LastName': 'Foo', 'Affiliation': 'Emergency Department, TTSH, Singapore.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Chan', 'Affiliation': 'Department of Geriatric Medicine, Tan Tock Seng Hospital (TTSH), Singapore; Institute of Geriatrics and Active Ageing (IGA), TTSH, Singapore.'}, {'ForeName': 'Wee Shiong', 'Initials': 'WS', 'LastName': 'Lim', 'Affiliation': 'Department of Geriatric Medicine, Tan Tock Seng Hospital (TTSH), Singapore; Institute of Geriatrics and Active Ageing (IGA), TTSH, Singapore.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2021.01.083'] 2392,33677172,A randomised controlled trial of laser acupuncture improves early outcomes of osteoarthritis patients' physical functional ability after total knee replacement.,"BACKGROUND AND PURPOSE Total knee replacement is the most effective intervention for late-stage osteoarthritis; however, a major concern is postoperative recovery of physical function. This randomised controlled trial evaluated the effects of acupuncture with low-level laser therapy (ALLLT) on early outcomes of physical function after total knee replacement. MATERIALS AND METHODS Eighty-two osteoarthritis patients were recruited and randomly assigned to the experimental group receiving ALLLT or the control group receiving sham ALLLT without laser beam output. Physical function was evaluated by assessing knee joint flexion and stiffness on days 1, 2, and 3 after total knee replacement. RESULTS Generalised estimating equations revealed a significant difference between the two groups in joint flexion. The experimental group displayed better joint flexion and less stiffness on days 2 and 3 than did the control group. CONCLUSION ALLLT can facilitate the recovery of physical function, as evidenced by knee joint flexion and stiffness, in patients receiving total knee replacement.",2021,"Physical function was evaluated by assessing knee joint flexion and stiffness on days 1, 2, and 3 after total knee replacement. ","['late-stage osteoarthritis', 'patients receiving total knee replacement', ""osteoarthritis patients' physical functional ability after total knee replacement"", 'Eighty-two osteoarthritis patients']","['laser acupuncture', 'acupuncture with low-level laser therapy (ALLLT', 'ALLLT or the control group receiving sham ALLLT without laser beam output']","['joint flexion', 'Physical function']","[{'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C3816958', 'cui_str': '80'}]","[{'cui': 'C0394654', 'cui_str': 'Laser acupuncture'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0458142', 'cui_str': 'Laser light'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}]","[{'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",82.0,0.0676184,"Physical function was evaluated by assessing knee joint flexion and stiffness on days 1, 2, and 3 after total knee replacement. ","[{'ForeName': 'Chiung-Hui', 'Initials': 'CH', 'LastName': 'Huang', 'Affiliation': 'Integration of Traditional Chinese Medicine with Western Nursing, National Taipei University of Nursing and Health Sciences, Nurse, Department of Nursing, Taipei Veterans General Hospital, 201, Sec. 2, Shipai Rd., Taipei City, 11217, Taiwan. Electronic address: chhuang10@vghtpe.gov.tw.'}, {'ForeName': 'Mei-Ling', 'Initials': 'ML', 'LastName': 'Yeh', 'Affiliation': 'Department of Nursing, National Taipei University of Nursing and Health Sciences, 365, Minte Rd., Taipei City, 11219, Taiwan. Electronic address: meiling@ntunhs.edu.tw.'}, {'ForeName': 'Fang-Pey', 'Initials': 'FP', 'LastName': 'Chen', 'Affiliation': 'Center for Traditional Medicine, Taipei Veterans General Hospital and Adjunct Professor, National Taipei University of Nursing and Health Sciences, 201, Sec. 2, Shipai Rd., Taipei City, 11217, Taiwan. Electronic address: fpchen@vghtpe.gov.tw.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Kuo', 'Affiliation': 'Department of Nursing, National Taipei University of Nursing and Health Sciences, Student, Taipei American School, 800, Sec. 6, Zhongshan N. Rd., Taipei City, 11152, Taiwan. Electronic address: 22matthewk@students.tas.tw.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101340'] 2393,33677157,The influence of high-frequency repetitive transcranial magnetic stimulation on endogenous estrogen in patients with disorders of consciousness.,"BACKGROUND Repetitive transcranial magnetic stimulation (rTMS) has been proposed as a promising therapeutic intervention for neurological disorders. However, the precise mechanisms of rTMS in neural excitability remains poorly understood. Estradiol is known to have strong influence on cortical excitability. This study aimed to determine whether high-frequency (HF) rTMS influences endogenous estradiol in male patients with disorders of consciousness (DOC). METHODS A randomized controlled trial was conducted with a total of 57 male patients with DOC. Eventually, 50 patients completed the study. Twenty-five patients underwent real rTMS, and 25 patients underwent sham rTMS, which were delivered over the dorsolateral prefrontal cortex. The primary outcome measure was the change in serum estradiol from baseline to after 10 sessions of HF-rTMS. The improvement in the total score of the JFK Coma Recovery Scale-Revised (CRS-R) was also assessed. RESULTS Changes in estradiol levels and CRS-R scores from pre-to post-treatment were significantly different between the active rTMS and sham stimulation conditions. A significant enhancement of CRS-R scores in the patients receiving rTMS stimulation was observed compared to the sham group. Serum estradiol levels in patients following HF-rTMS were significantly higher than their baseline levels, whereas no significant changes were found in the sham group from pre-to post-stimulation. The rise in estradiol levels was greater in responders than in non-responders. The changes in estradiol levels were significantly positively correlated with the improvement in CRS-R scores. CONCLUSION These preliminary findings indicate that serum estradiol levels are affected by HF-rTMS and positively related to clinical responses in male patients with DOC. The elevation of estradiol levels may lay a physiological foundation for successful rTMS treatment for DOC patients by increasing cortical excitability.",2021,"RESULTS Changes in estradiol levels and CRS-R scores from pre-to post-treatment were significantly different between the active rTMS and sham stimulation conditions.","['50 patients completed the study', 'male patients with DOC', '57 male patients with DOC', 'patients with disorders of consciousness', 'male patients with disorders of consciousness (DOC']","['Estradiol', 'real rTMS', 'Repetitive transcranial magnetic stimulation (rTMS', 'rTMS', 'high-frequency (HF) rTMS', 'sham rTMS', 'high-frequency Repetitive Transcranial Magnetic Stimulation']","['estradiol levels and CRS-R scores', 'rise in estradiol levels', 'serum estradiol levels', 'elevation of estradiol levels', 'total score of the JFK Coma Recovery Scale-Revised (CRS-R', 'estradiol levels', 'change in serum estradiol', 'CRS-R scores', 'Serum estradiol levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009792', 'cui_str': 'Consciousness Disorders'}]","[{'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0337434', 'cui_str': 'Estradiol measurement'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",57.0,0.133686,"RESULTS Changes in estradiol levels and CRS-R scores from pre-to post-treatment were significantly different between the active rTMS and sham stimulation conditions.","[{'ForeName': 'Ren Hong', 'Initials': 'RH', 'LastName': 'He', 'Affiliation': 'Department of Rehabilitation Medicine, Nanfang Hospital, Southern Medical University, P.R. China.'}, {'ForeName': 'Hui Juan', 'Initials': 'HJ', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, Nanfang Hospital, Southern Medical University, P.R. China.'}, {'ForeName': 'Zhou', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Rehabilitation Medicine, Nanfang Hospital, Southern Medical University, P.R. China.'}, {'ForeName': 'Jian Zhong', 'Initials': 'JZ', 'LastName': 'Fan', 'Affiliation': 'Department of Rehabilitation Medicine, Nanfang Hospital, Southern Medical University, P.R. China.'}, {'ForeName': 'Sheng Quan', 'Initials': 'SQ', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Medicine, Nanfang Hospital, Southern Medical University, P.R. China.'}, {'ForeName': 'Yu Hua', 'Initials': 'YH', 'LastName': 'Zhong', 'Affiliation': 'Department of Rehabilitation Medicine, Nanfang Hospital, Southern Medical University, P.R. China. Electronic address: zhongbinyue@163.com.'}]",Brain stimulation,['10.1016/j.brs.2021.02.014'] 2394,33677046,Sex-dependent complex association of TPH2 with multiple dimensions of ADHD.,"BACKGROUND Tryptophan hydroxylase 2 (TPH2) is a key enzyme in the biosynthesis of serotonin in the brain. This study aims to investigate the role of a functional variant in TPH2 (rs17110747) in the pathophysiology of ADHD. This variant has been implicated in mood disorders in recent meta-analysis. This study uses a comprehensive approach that combines association testing and pharmaco-dynamic evaluation of behaviour, in a large sample of children with ADHD (n = 570). METHODS The association between various ADHD relevant traits and rs17110747 was analyzed using family-based association tests (FBAT). Children were assessed by parents, teachers and research staff under three experimental conditions (EC): baseline, placebo, and methylphenidate using a double-blind placebo-controlled crossover trial. OUTCOMES FBAT analysis conducted in a sample stratified based on sex of the proband, showed that there was a highly significant overtransmission of the G allele from parents to affected girls. In addition, significant association with several behavioral and cognitive dimensions of ADHD was observed only when the proband was female. Further, girls with the G/G genotype (rs17110747) had greater response to placebo when evaluated by parents. INTERPRETATION These results suggest that there may be a complex association of TPH2 in the etiology of ADHD, with a sex-specific effect.",2021,"Further, girls with the G/G genotype (rs17110747) had greater response to placebo when evaluated by parents. ",['children with ADHD (n\u202f=\u202f570'],"['placebo, and methylphenidate using a double-blind placebo', 'placebo']",['several behavioral and cognitive dimensions of ADHD'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}]",,0.110759,"Further, girls with the G/G genotype (rs17110747) had greater response to placebo when evaluated by parents. ","[{'ForeName': 'Weam', 'Initials': 'W', 'LastName': 'Fageera', 'Affiliation': 'Douglas Mental Health University Institute, Montreal, Quebec, Canada; Department of Human Genetics, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Sarojini M', 'Initials': 'SM', 'LastName': 'Sengupta', 'Affiliation': 'Douglas Mental Health University Institute, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Marie-Ève', 'Initials': 'MÈ', 'LastName': 'Fortier', 'Affiliation': 'Douglas Mental Health University Institute, Montreal, Quebec, Canada.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Grizenko', 'Affiliation': 'Douglas Mental Health University Institute, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Babienco', 'Affiliation': 'Department of Decision Sciences, HEC Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Aurelie', 'Initials': 'A', 'LastName': 'Labbe', 'Affiliation': 'Department of Decision Sciences, HEC Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Ridha', 'Initials': 'R', 'LastName': 'Joober', 'Affiliation': 'Douglas Mental Health University Institute, Montreal, Quebec, Canada; Department of Human Genetics, McGill University, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada; Department of Neurology and Neurosurgery, McGill University, Montreal, Quebec, Canada. Electronic address: ridha.joober@douglas.mcgill.ca.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2021.110296'] 2395,33682773,Effects of core-postural stabilisation on fluoroscopy diaphragmatic measurement and dyspnea in chronic obstructive pulmonary disease: A randomized single-blinded clinical trial.,"BACKGROUND While respiratory and core-postural stabilisation has recently gained a widespread acceptance to improve pulmonary function and dyspena, the therapeutic effects of and rationale underlying the use of respiratory and core-postural stabilisation in the management of patients with chronic obstructive pulmonary disease have not been investigated. OBJECTIVE This study aimed to compare the effects of abdominal breathing and respiratory and core-postural stabilisation on diaphragmatic movement and pulmonary function. METHODS Fourteen patients with moderate chronic obstructive pulmonary disease were randomly assigned to either the respiratory and core-postural stabilisation or abdominal breathing group. All patients underwent fluoroscopy-guided chest X-ray imaging and pulmonary function tests before and after the interventions; the modified Medical Research Council questionnaire was also administered before and after the interventions. Six sessions of either intervention were consistently provided. The obtained data were assessed using independent t-tests and Wilcoxon signed-rank test with a significance threshold of P< 0.05. RESULTS Respiratory and core-postural stabilisation was more effective in increasing diaphragmatic movements than abdominal breathing (P< 0.05). Pulmonary function tests revealed more significant differences in the forced vital capacity (FVC(%)predicted) only after respiratory and core-postural stabilisation (P= 0.004). The Medical Research Council questionnaire score was significantly different within the Respiratory and core-postural stabilisation group (P= 0.014). CONCLUSIONS Our novel results suggest that the effects of respiratory and core-postural stabilisation breathing on diaphragmatic movement and pulmonary function were superior to those of abdominal breathing in patients with chronic obstructive pulmonary disease.",2021,"RESULTS Respiratory and core-postural stabilisation was more effective in increasing diaphragmatic movements than abdominal breathing (P< 0.05).","['chronic obstructive pulmonary disease', 'Fourteen patients with moderate chronic obstructive pulmonary disease', 'patients with chronic obstructive pulmonary disease']","['abdominal breathing and respiratory and core-postural stabilisation', 'fluoroscopy-guided chest X-ray imaging and pulmonary function tests', 'core-postural stabilisation', 'respiratory and core-postural stabilisation breathing', 'respiratory and core-postural stabilisation or abdominal breathing group']","['forced vital capacity (FVC(%)predicted) only after respiratory and core-postural stabilisation', 'diaphragmatic movements', 'Medical Research Council questionnaire score', 'fluoroscopy diaphragmatic measurement and dyspnea', 'diaphragmatic movement and pulmonary function']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0730605', 'cui_str': 'Moderate chronic obstructive pulmonary disease'}]","[{'cui': 'C0231898', 'cui_str': 'Diaphragmatic breathing'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0232079', 'cui_str': 'Diaphragmatic movement'}, {'cui': 'C0451290', 'cui_str': 'Medical Research Council questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}]",14.0,0.0411791,"RESULTS Respiratory and core-postural stabilisation was more effective in increasing diaphragmatic movements than abdominal breathing (P< 0.05).","[{'ForeName': 'Gihoon', 'Initials': 'G', 'LastName': 'Jung', 'Affiliation': 'Department of Rehabilitation Medicine, WonKwang University SanBon Hospital, Gunpo, Korea.'}, {'ForeName': 'Chanhee', 'Initials': 'C', 'LastName': 'Park', 'Affiliation': 'Sports Movement Artificial Robotics Technology (SMART) Institute, Department of Physical Therapy, Yonsei University, Wonju, Korea.'}, {'ForeName': 'Jongseok', 'Initials': 'J', 'LastName': 'Hwang', 'Affiliation': 'Sports Movement Artificial Robotics Technology (SMART) Institute, Department of Physical Therapy, Yonsei University, Wonju, Korea.'}, {'ForeName': 'Joshua Sung H', 'Initials': 'JSH', 'LastName': 'You', 'Affiliation': 'Sports Movement Artificial Robotics Technology (SMART) Institute, Department of Physical Therapy, Yonsei University, Wonju, Korea.'}, {'ForeName': 'Chunghwi', 'Initials': 'C', 'LastName': 'Yi', 'Affiliation': 'Department of Physical Therapy, Yonsei University, Wonju, Korea.'}, {'ForeName': 'Woochol Joseph', 'Initials': 'WJ', 'LastName': 'Choi', 'Affiliation': 'Department of Physical Therapy, Yonsei University, Wonju, Korea.'}]",Technology and health care : official journal of the European Society for Engineering and Medicine,['10.3233/THC-218034'] 2396,33682752,Effects of masticatory exercise on cognitive function in community-dwelling older adults.,"BACKGROUND Mastication improves cognitive function by activating cerebral cortical activity, and it is important to demonstrate the cognitive effects of masticatory training using a variety of different interventions. OBJECTIVE This study aimed to evaluate the effects of masticatory exercise on cognitive function in healthy older adults living in the community. METHODS For six weeks, twelve participants performed a masticatory exercise using a NOSICK exerciser device, and thirteen subjects performed daily life without masticatory exercises. Trail Making Test, Digit Span Test, and Stroop test were used to measure the cognitive function. RESULTS The participants in the experimental group showed significant improvements in TMT-A/B (p= 0.001 and 0.004), DST-forward (p= 0.001), and ST-word (p= 0.001). The effect sizes after the intervention were calculated as (1.2 and 0.8) for TMT-A/B, (0.8 and 0.2) for Digit Span Test forward/backward, and (0.6 and 0.2) for Stroop test color/word. CONCLUSIONS We suggest that the masticatory exercises improve cognitive function in healthy older adults. Therefore, masticatory exercises can be used as a therapeutic exercise during cognitive rehabilitation.",2021,"The participants in the experimental group showed significant improvements in TMT-A/B (p= 0.001 and 0.004), DST-forward (p= 0.001), and ST-word (p= 0.001).","['healthy older adults living in the community', 'healthy older adults', 'community-dwelling older adults']","['masticatory exercise using a NOSICK exerciser device, and thirteen subjects performed daily life without masticatory exercises', 'masticatory exercises', 'masticatory exercise']","['TMT-A/B', 'cognitive function']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0419105', 'cui_str': 'Masticatory exercises'}, {'cui': 'C0180776', 'cui_str': 'Exerciser'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0040604', 'cui_str': 'Trail making test'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",12.0,0.0335782,"The participants in the experimental group showed significant improvements in TMT-A/B (p= 0.001 and 0.004), DST-forward (p= 0.001), and ST-word (p= 0.001).","[{'ForeName': 'Tae-Hoon', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': ''}]",Technology and health care : official journal of the European Society for Engineering and Medicine,['10.3233/THC-218013'] 2397,33681988,Matrix-free 3D culture supports human follicular development from the unilaminar to the antral stage in vitro yielding morphologically normal metaphase II oocytes.,"STUDY QUESTION Can group culture with stage-specific anti-Müllerian hormone (AMH) modulation support human follicular development and oocyte maturation in vitro? SUMMARY ANSWER In the presence of FSH, AMH supplementation at the secondary-to-early antral stage followed by AMH depletion promotes the coordinated growth and function of human follicles during group culture, thereby yielding mature oocytes. WHAT IS KNOWN ALREADY Stage-specific AMH modulation promotes in-vitro development of nonhuman primate follicles. The group culture method supports nonhuman primate follicle growth from the primary to antral stage, producing developmentally competent oocytes. STUDY DESIGN, SIZE, DURATION Ovarian tissue samples were collected from 19 patients of reproductive age (22-47 years old having menstrual cycles) who underwent oophorectomy or hysterectomy for clinical purposes. Tissue pieces were cultured in a matrix-free system for 3 weeks followed by isolation of follicles for the subsequent 6-week individual or group culture. PARTICIPANTS/MATERIALS, SETTING, METHODS Pieces of ovarian cortical tissue were cultured to support primordial follicle activation and early-stage follicle growth. Secondary follicles isolated from cultured tissue were then randomly assigned to two groups for individual culture: control and AMH modulation, i.e., recombinant human AMH protein supplementation during the secondary-to-early antral stage followed by the addition of neutralizing anti-human AMH antibody. Secondary follicles were also cultured in groups with the same AMH modulation. Follicle survival, growth, steroid hormone and paracrine factor production, steroidogenic protein expression, as well as oocyte maturation and morphology were assessed. MAIN RESULTS AND THE ROLE OF CHANCE Follicles grew to the secondary stage during 3 weeks of ovarian tissue culture. In-vitro-developed follicles expressed AMH and levels of secreted AMH increased (P < 0.05) in the culture media over time. Secondary follicles isolated from cultured ovarian tissue survived and grew to the antral stage during 6 weeks of individual follicle culture. In-vitro-developed antral follicles produced granulosa and theca cell-derived steroid hormones and paracrine factors, which were detectable in the culture media. Germinal vesicle oocytes obtained from cultured follicles exhibited a perinucleolar chromatin rim configuration. AMH modulation did not alter follicle survival or oocyte maturation relative to those of the control follicles. However, follicle diameters, as well as steroid hormone and paracrine factor production, increased (P < 0.05) in the AMH-modulation group compared with the control group. Secondary follicles isolated from cultured ovarian tissue formed aggregates and grew to the antral stage during 6 weeks of group culture. In-vitro-developed antral follicles expressed steroidogenic enzymes and secreted steroid hormones were detectable in the culture media. Oocytes obtained from cultured follicle aggregates with AMH-modulation progressed to the metaphase II stage after IVM, containing a normal-sized first polar body and meiotic spindle. Oocytes exhibited a typical ultrastructure. LIMITATIONS, REASONS FOR CAUTION Follicles were obtained from fresh ovarian tissue of adult patients. Oocyte maturation rates were relatively low and oocytes were assessed by morphological evaluation. Owing to the lack of a control group, the beneficial effects of AMH modulation remained undetermined for the group culture in this study. WIDER IMPLICATIONS OF THE FINDINGS Stage-specific AMH modulation supports human follicular development in the matrix-free group culture, which is consistent with previously reported AMH actions on growing follicles in nonhuman primates. Oocytes generated by in-vitro-developed follicles achieve meiotic maturation with a typical morphology and ultrastructure, which supports in-vitro follicle maturation as a potential approach for fertility preservation in women. STUDY FUNDING/COMPETING INTEREST(S) NICHD R01HD082208 and NIH Office of the Director P51OD011092. The authors have no competing interest to declare. TRIAL REGISTRATION NUMBER N/A.",2021,In-vitro-developed follicles expressed AMH and levels of secreted AMH increased (P < 0.05) in the culture media over time.,"['Secondary follicles isolated from cultured tissue', 'Ovarian tissue samples were collected from 19 patients of reproductive age (22-47\u2009years old having menstrual cycles) who underwent oophorectomy or hysterectomy for clinical purposes', 'Pieces of ovarian cortical tissue were cultured to support primordial follicle activation and early-stage follicle growth']","['stage-specific anti-Müllerian hormone (AMH', 'recombinant human AMH protein supplementation']","['follicles expressed AMH and levels of secreted AMH', 'follicle survival or oocyte maturation', 'steroid hormone and paracrine factor production', 'cultured ovarian tissue survived and grew to the antral stage', 'Oocyte maturation rates', 'cultured ovarian tissue formed aggregates and grew to the antral stage', 'Follicle survival, growth, steroid hormone and paracrine factor production, steroidogenic protein expression, as well as oocyte maturation and morphology']","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0586787', 'cui_str': 'Tissue specimen from ovary'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0029936', 'cui_str': 'Oophorectomy'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0682768', 'cui_str': 'Protein hormone'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0301818', 'cui_str': 'Steroid hormone'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0293352', 'cui_str': 'Antral'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0205418', 'cui_str': 'Aggregate'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}]",,0.0414807,In-vitro-developed follicles expressed AMH and levels of secreted AMH increased (P < 0.05) in the culture media over time.,"[{'ForeName': 'Fuhua', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Division of Reproductive Endocrinology, Department of Obstetrics and Gynecology, School of Medicine, Oregon Health &\xa0Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Maralee S', 'Initials': 'MS', 'LastName': 'Lawson', 'Affiliation': 'Division of Reproductive &\xa0Developmental Sciences, Oregon National Primate Research Center, Oregon Health &\xa0Science University, Beaverton, OR 97006, USA.'}, {'ForeName': 'Yukie', 'Initials': 'Y', 'LastName': 'Bean', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, School of Medicine, Oregon Health &\xa0Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Alison Y', 'Initials': 'AY', 'LastName': 'Ting', 'Affiliation': 'Division of Reproductive &\xa0Developmental Sciences, Oregon National Primate Research Center, Oregon Health &\xa0Science University, Beaverton, OR 97006, USA.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Pejovic', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, School of Medicine, Oregon Health &\xa0Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'De Geest', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, School of Medicine, Oregon Health &\xa0Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Moffitt', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, School of Medicine, Oregon Health &\xa0Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Shoukhrat M', 'Initials': 'SM', 'LastName': 'Mitalipov', 'Affiliation': 'Division of Reproductive &\xa0Developmental Sciences, Oregon National Primate Research Center, Oregon Health &\xa0Science University, Beaverton, OR 97006, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Division of Reproductive Endocrinology, Department of Obstetrics and Gynecology, School of Medicine, Oregon Health &\xa0Science University, Portland, OR 97239, USA.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/deab003'] 2398,33686610,"Evaluation of tramadol human pharmacokinetics and safety after co-administration of magnesium ions in randomized, single- and multiple-dose studies.","BACKGROUND Magnesium ions (Mg 2+ ) increase and prolong opioid analgesia in chronic and acute pain. The nature of this synergistic analgesic interaction has not yet been explained. Our aim was to investigate whether Mg 2+ alter tramadol pharmacokinetics. Our secondary goal was to assess the safety of the combination. METHODS Tramadol was administered to healthy Caucasian subjects with and without Mg 2+ as (1) single 100-mg and (2) multiple 50-mg oral doses. Mg 2+ was administered orally at doses of 150 mg and 75 mg per tramadol dosing in a single- and multiple-dose study, respectively. Both studies were randomized, open label, laboratory-blinded, two-period, two-treatment, crossover trials. The plasma concentrations of tramadol and its active metabolite, O-desmethyltramadol, were measured. RESULTS A total of 25 and 26 subjects completed the single- and multiple-dose study, respectively. Both primary and secondary pharmacokinetic parameters were similar. The 90% confidence intervals for C max and AUC 0-t geometric mean ratios for tramadol were 91.95-102.40% and 93.22-102.76%. The 90% confidence intervals for C max,ss and AUC 0-τ geometric mean ratios for tramadol were 93.85-103.31% and 99.04-105.27%. The 90% confidence intervals for primary pharmacokinetic parameters were within the acceptance range. ANOVA did not show any statistically significant contribution of the formulation factor (p > 0.05) in either study. Adverse events and clinical safety were similar in the presence and absence of Mg 2+ . CONCLUSIONS The absence of Mg 2+ interaction with tramadol pharmacokinetics and safety suggests that this combination may be used in the clinical practice for the pharmacotherapy of pain.",2021,ANOVA did not show any statistically significant contribution of the formulation factor (p > 0.05) in either study.,"['chronic and acute pain', 'A total of 25 and 26 subjects', 'healthy Caucasian subjects with and without Mg 2+ as (1) single 100-mg and (2) multiple 50-mg oral doses']","['Tramadol', 'tramadol']","['plasma concentrations of tramadol and its active metabolite, O-desmethyltramadol', 'C max and AUC 0-t geometric mean ratios for tramadol', 'C max,ss and AUC 0-τ geometric mean ratios for tramadol', 'Adverse events and clinical safety']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0215051', 'cui_str': 'O-desmethyltramadol'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0947021,ANOVA did not show any statistically significant contribution of the formulation factor (p > 0.05) in either study.,"[{'ForeName': 'Piotr J', 'Initials': 'PJ', 'LastName': 'Rudzki', 'Affiliation': 'Łukasiewicz Research Network - Pharmaceutical Research Institute, ul. Rydygiera 8, 02-091, Warsaw, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Jarus-Dziedzic', 'Affiliation': 'BioVirtus Research Site Sp, ul. Borowa 14/18, 05-400, Otwock, Poland.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Filist', 'Affiliation': 'Łukasiewicz Research Network - Pharmaceutical Research Institute, ul. Rydygiera 8, 02-091, Warsaw, Poland.'}, {'ForeName': 'Edyta', 'Initials': 'E', 'LastName': 'Gilant', 'Affiliation': 'Łukasiewicz Research Network - Pharmaceutical Research Institute, ul. Rydygiera 8, 02-091, Warsaw, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Buś-Kwaśnik', 'Affiliation': 'Łukasiewicz Research Network - Pharmaceutical Research Institute, ul. Rydygiera 8, 02-091, Warsaw, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Leś', 'Affiliation': 'Łukasiewicz Research Network - Pharmaceutical Research Institute, ul. Rydygiera 8, 02-091, Warsaw, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Sasinowska-Motyl', 'Affiliation': 'Department of Pharmacodynamics, Centre for Preclinical Research and Technology, Medical University of Warsaw, ul. Banacha 1b, 01-793, Warsaw, Poland.'}, {'ForeName': 'Łukasz', 'Initials': 'Ł', 'LastName': 'Nagraba', 'Affiliation': 'Orthopedic and Rehabilitation Department, Medical University of Warsaw, ul. Kondratowicza 8, 03-242, Warsaw, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Bujalska-Zadrożny', 'Affiliation': 'Department of Pharmacodynamics, Centre for Preclinical Research and Technology, Medical University of Warsaw, ul. Banacha 1b, 01-793, Warsaw, Poland. magdalena.bujalska@wum.edu.pl.'}]",Pharmacological reports : PR,['10.1007/s43440-021-00239-x'] 2399,33667960,Investigation on the effectiveness of abdominal hollowing home-exercises using a portable ultrasound: Randomized controlled trial.,"We used a 3-arm randomized control trial to investigate whether abdominal hollowing (AH) home exercise using pocket-sized ultrasonography (US)-miruco (AH with miruco group)-was more effective than conventional AH home exercise using abdominal palpation and or also a wait-and-see approach (control group) to improve isolated control of the transversus abdominis (TrA) muscle during AH. We randomized 60 participants with low back pain into the three groups equally. Primary outcome measures for the US group were percentage of change in TrA thickness and excursion of the edge of the TrA fascia during AH when the thickness of the internal or external oblique muscles increased. Score on the Oswestry Disability Index (ODI) was a secondary outcome measure. The intervention period was 1 week, followed by 1 week without intervention. As a result, we found no statistically significant interaction effect (P > .05) in changes of the primary outcome measures from baseline for each follow-up period. The AH with miruco group had a statistically lower ODI (P = .036) than did the control group after the intervention. Results indicate a limited benefit for use of the miruco in AH home exercise to improve isolated control of the TrA muscle during AH.",2021,The AH with miruco group had a statistically lower ODI (P = .036),['60 participants with low back pain into the three groups equally'],"['abdominal hollowing home-exercises', 'abdominal hollowing (AH) home exercise using pocket-sized ultrasonography (US)-miruco (AH with miruco group)-was', 'conventional AH home exercise using abdominal palpation and or also a wait-and-see approach (control group) to improve isolated control of the transversus abdominis (TrA) muscle during AH']","['percentage of change in TrA thickness and excursion of the edge of the TrA fascia during AH when the thickness of the internal or external oblique muscles increased', 'ODI', 'Oswestry Disability Index (ODI']","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0030248', 'cui_str': 'Palpation of abdomen'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0224375', 'cui_str': 'External Oblique Muscle'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}]",60.0,0.0507781,The AH with miruco group had a statistically lower ODI (P = .036),"[{'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Takasaki', 'Affiliation': 'Department of Physical Therapy, Saitama Prefectural University, Saitama, Japan. Electronic address: physical.therapy.takasaki@gmail.com.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Kawazoe', 'Affiliation': 'Department of Physical Therapy, Saitama Prefectural University, Saitama, Japan.'}]",Journal of electromyography and kinesiology : official journal of the International Society of Electrophysiological Kinesiology,['10.1016/j.jelekin.2021.102532'] 2400,33667827,An emotional regulation approach to psychosis recovery: The Living Through Psychosis group programme.,"BACKGROUND AND OBJECTIVES Research indicates the value of targeting emotional regulation (ER) skills in psychological interventions for psychosis. These skills can be delivered in a group format, thereby increasing access to therapy. This pilot study examined the acceptability and clinical effects of teaching ER skills in The Living Through Psychosis (LTP) group programme. METHODS Patients with a psychotic illness were offered the LTP programme, comprising eight sessions over four weeks. Measures were completed by 55 participants. Acceptability was assessed by attendance rates and group cohesion. Measures of intervention targets, recovery and clinical outcomes were completed at baseline, pre-group, post-group, and one-month follow-up. RESULTS High group attendance and cohesion support the acceptability of the group. Participants reported less difficulty with ER (Coeff. = -8.29, 95% CI: -13.40 to -3.18, within participant uncontrolled effect size (ES) d = 0.29), increased mindful relating to distressing symptoms (Coeff. = 11.20, 95% CI: 7.02 to 15.38, d = 0.65), and improvements in recovery dimensions (Coeff. = 10.07, 95% CI: 5.6 to 14.54, d = 0.42) from pre-to post-intervention, and maintained at one-month follow-up. Participants' hallucinations and delusions reduced from pre-intervention to follow-up (t(18) = 4.64, p < 0.001; t(18) = 5.34, p < 0.001). There was no change in fear of relapse. LIMITATIONS The uncontrolled, pre-post design precluded blinded assessments, and may have inflated effect sizes. Other factors may have contributed to the improvements. CONCLUSIONS The LTP programme was acceptable to people with psychosis. The preliminary findings indicate the potential utility of teaching ER and mindfulness skills in a brief group programme. Findings require replication in a randomized controlled trial.",2021,"Participants' hallucinations and delusions reduced from pre-intervention to follow-up (t(18) = 4.64, p < 0.001; t(18) = ",['Patients with a psychotic illness'],"['LTP programme', 'teaching ER skills']","['recovery dimensions (Coeff', 'Acceptability', 'hallucinations and delusions', 'fear of relapse', 'recovery and clinical outcomes', 'mindful relating to distressing symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]","[{'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]","[{'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0018524', 'cui_str': 'Hallucinations'}, {'cui': 'C0011253', 'cui_str': 'Delusions'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.196434,"Participants' hallucinations and delusions reduced from pre-intervention to follow-up (t(18) = 4.64, p < 0.001; t(18) = ","[{'ForeName': 'Aisling', 'Initials': 'A', 'LastName': 'Ryan', 'Affiliation': 'School of Psychology, Trinity College Dublin, Ireland; Health Service Executive, Ireland.'}, {'ForeName': 'Edel', 'Initials': 'E', 'LastName': 'Crehan', 'Affiliation': ""Department of Psychology, St Patrick's Mental Health Services, Dublin, Ireland.""}, {'ForeName': 'Mizanur', 'Initials': 'M', 'LastName': 'Khondoker', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Fell', 'Affiliation': 'School of Psychology, Trinity College Dublin, Ireland; Health Service Executive, Ireland.'}, {'ForeName': 'Roisin', 'Initials': 'R', 'LastName': 'Curtin', 'Affiliation': ""Department of Psychology, St Patrick's Mental Health Services, Dublin, Ireland.""}, {'ForeName': 'Louise C', 'Initials': 'LC', 'LastName': 'Johns', 'Affiliation': 'Department of Psychiatry, University of Oxford, UK; Oxford Health NHS Foundation Trust, Oxford, UK. Electronic address: louise.johns@psych.ox.ac.uk.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2021.101651'] 2401,33667699,Alternate sessions of transcranial direct current stimulation (tDCS) reduce chronic pain in women affected by chikungunya. A randomized clinical trial.,"CONTEXT Thousands of people worldwide have been infected by the chikungunya virus (CHIKV), and the persistence of joint pain symptoms has been considered the main problem. Neuromodulation techniques such as transcranial direct current stimulation (tDCS) act on brain areas involved in the processing of chronic pain. It was previously demonstrated that tDCS for five consecutive days significantly reduced pain in the chronic phase of chikungunya (CHIK). OBJECTIVE To analyze the effect of alternate tDCS sessions on pain and functional capacity in individuals affected by CHIK. METHODS In a randomized clinical trial, 58 women in the chronic phase of CHIK were divided into two groups: active-tDCS (M1-S0, 2 mA, 20 min) and sham-tDCS. The Visual Analogue Scale (VAS) and the Brief Pain Inventory (BPI) were used to assess pain, while the Health Assessment Questionnaire (HAQ) assessed functional capacity. These scales were used before and after six sessions of tDCS in nonconsecutive days on the primary motor cortex, and at follow-up consultation 7 and 15 days after the last session. A repeated measures mixed-model ANOVA was used for comparison between groups (significant p-values < 0.05). RESULTS A significant pain reduction (Z [3, 171] = 14.303; p < 0.0001) was observed in the tDCS group compared to the sham group; no significant difference in functional capacity was observed (Z [1.57] = 2.797; p = 0.1). CONCLUSION Our results suggest that six nonconsecutive sessions of active tDCS on M1 reduce pain in chronic CHIKV arthralgia.",2021,"These scales were used before and after six sessions of tDCS in nonconsecutive days on the primary motor cortex, and at follow-up consultation 7 and 15 days after the last session.","['women affected by chikungunya', '58 women in the chronic phase of CHIK', 'individuals affected by CHIK']","['alternate tDCS sessions', 'transcranial direct current stimulation (tDCS', 'tDCS', 'active tDCS (M1-S0, 2mA, 20 minutes) and sham']","['Visual Analogue Scale (VAS) and Brief Pain Inventory (BPI', 'pain and functional capacity', 'pain, while the Health Assessment Questionnaire (HAQ) assessed functional capacity', 'pain reduction', 'functional capacity', 'chronic pain', 'pain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0008055', 'cui_str': 'Chikungunya fever'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]",58.0,0.0860557,"These scales were used before and after six sessions of tDCS in nonconsecutive days on the primary motor cortex, and at follow-up consultation 7 and 15 days after the last session.","[{'ForeName': 'Clecio Gabriel', 'Initials': 'CG', 'LastName': 'De Souza', 'Affiliation': 'Federal University of Rio Grande Do Norte, Postgraduate Program in Rehabilitation Sciences, Santa Cruz, RN, Brazil; Graduate Program in Collective Health, Universidade Federal do Rio Grande do Norte, Natal, RN, Brazil. Electronic address: cleciogabriel@ufrn.edu.br.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Pegado', 'Affiliation': 'Federal University of Rio Grande Do Norte, Postgraduate Program in Rehabilitation Sciences, Santa Cruz, RN, Brazil; NAPeN Network (Rede de Núcleos de Assistência e Pesquisa em Neuromodulação), Brazil. Electronic address: rodrigopegado@gmail.com.'}, {'ForeName': 'Jardson', 'Initials': 'J', 'LastName': 'Costa', 'Affiliation': 'Faculty Estacio of Rio Grande Do Norte, Natal, RN, Brazil.'}, {'ForeName': 'Edgard', 'Initials': 'E', 'LastName': 'Morya', 'Affiliation': 'Edmond and Lily Safra International Neuroscience Institute, Santos Dumont Institute, Macaíba, RN, Brazil; Brazilian Institute of Neuroscience and Neurotechnology (BRAINN/CEPID-FAPESP), University of Campinas, Campinas, São Paulo, Brazil; NAPeN Network (Rede de Núcleos de Assistência e Pesquisa em Neuromodulação), Brazil. Electronic address: edgard.morya@isd.org.br.'}, {'ForeName': 'Abrahão Fontes', 'Initials': 'AF', 'LastName': 'Baptista', 'Affiliation': 'Universidade Federal do ABC, Center for Mathematics, Computing and Cognition, São Bernardo do Campo, SP, Brazil; Brazilian Institute of Neuroscience and Neurotechnology (BRAINN/CEPID-FAPESP), University of Campinas, Campinas, São Paulo, Brazil; NAPeN Network (Rede de Núcleos de Assistência e Pesquisa em Neuromodulação), Brazil.'}, {'ForeName': 'Gozde', 'Initials': 'G', 'LastName': 'Unal', 'Affiliation': 'Department of Biomedical Engineering, The City College of New York, NY, USA.'}, {'ForeName': 'Marom', 'Initials': 'M', 'LastName': 'Bikson', 'Affiliation': 'Department of Biomedical Engineering, The City College of New York, NY, USA.'}, {'ForeName': 'Alexandre Hideki', 'Initials': 'AH', 'LastName': 'Okano', 'Affiliation': 'Universidade Federal do ABC, Center for Mathematics, Computing and Cognition, São Bernardo do Campo, SP, Brazil; Brazilian Institute of Neuroscience and Neurotechnology (BRAINN/CEPID-FAPESP), University of Campinas, Campinas, São Paulo, Brazil; NAPeN Network (Rede de Núcleos de Assistência e Pesquisa em Neuromodulação), Brazil. Electronic address: alexandre.okano@ufabc.edu.br.'}]",Brain stimulation,['10.1016/j.brs.2021.02.015'] 2402,33673587,Prospective Randomized Controlled Trial on the Effects of Almonds on Facial Wrinkles and Pigmentation.,"BACKGROUND Almonds have long been studied as a rich source of fatty acids, phytochemical polyphenols and antioxidants such as vitamin E. A recent study compared almond supplementations to a calorie-matched intervention for 16 weeks, yielding statistically significant improvement in wrinkle severity in postmenopausal women with Fitzpatrick skin types I and II that received almonds. This study furthers that assessment with a larger population and duration of 24 weeks to assess the influence of almond consumption on wrinkle severity, skin pigmentation and other skin biophysical profiles. OBJECTIVE To investigate the effects of almond consumption on photoaging such as wrinkles and pigment intensity as well as facial biophysical parameters such as sebum production, skin hydration and water loss. DESIGN AND INTERVENTIONS A prospective, randomized controlled study assessed postmenopausal women with Fitzpatrick skin types I or II who consumed 20% of their daily energy consumption in either almonds or a calorie-matched snack for 24 weeks. A facial photograph and image analysis system was used to obtain standardized high-resolution photographs and information on wrinkle width and severity at 0, 8, 16 and 24 weeks. Measurements of transepidermal water loss (TEWL), skin pigmentation, skin hydration and sebum production were also completed at each visit. RESULTS The average wrinkle severity was significantly decreased in the almond intervention group at week 16 and week 24 compared to baseline by 15% and 16%, respectively. Facial pigment intensity was decreased 20% in the almond group at week 16 and this was maintained by week 24. There were no significant differences in skin hydration or TEWL in the almond group compared to the control, although sebum excretion was increased in the control group. CONCLUSION The daily consumption of almonds may improve several aspects of photoaging such as facial wrinkles and pigment intensity in postmenopausal women. In conclusion, the daily consumption of almonds may contribute to the improvement of facial wrinkles and reduction of skin pigmentation among postmenopausal women with Fitzpatrick skin types I and II.",2021,"There were no significant differences in skin hydration or TEWL in the almond group compared to the control, although sebum excretion was increased in the control group. ","['postmenopausal women', 'postmenopausal women with Fitzpatrick skin types I or II who consumed 20% of their daily energy consumption in either almonds or a calorie-matched snack for 24 weeks', 'postmenopausal women with Fitzpatrick skin types I and II', 'postmenopausal women with Fitzpatrick skin types']",['almond consumption'],"['Facial pigment intensity', 'skin pigmentation', 'wrinkle severity, skin pigmentation and other skin biophysical profiles', 'average wrinkle severity', 'sebum production, skin hydration and water loss', 'wrinkle severity', 'sebum excretion', 'transepidermal water loss (TEWL), skin pigmentation, skin hydration and sebum production', 'skin hydration or TEWL']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0440286', 'cui_str': 'Almond'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0037290', 'cui_str': 'Skin pigmentation'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0005553', 'cui_str': 'Biophysics'}, {'cui': 'C0036511', 'cui_str': 'Sebum'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}]",,0.0353015,"There were no significant differences in skin hydration or TEWL in the almond group compared to the control, although sebum excretion was increased in the control group. ","[{'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Rybak', 'Affiliation': 'Department of Dermatology, University of California-Davis, Sacramento, CA 95816, USA.'}, {'ForeName': 'Alexis E', 'Initials': 'AE', 'LastName': 'Carrington', 'Affiliation': 'Department of Dermatology, University of California-Davis, Sacramento, CA 95816, USA.'}, {'ForeName': 'Simran', 'Initials': 'S', 'LastName': 'Dhaliwal', 'Affiliation': 'Department of Dermatology, University of California-Davis, Sacramento, CA 95816, USA.'}, {'ForeName': 'Aliza', 'Initials': 'A', 'LastName': 'Hasan', 'Affiliation': 'Department of Dermatology, Southern Illinois University, Springfield, IL 62901, USA.'}, {'ForeName': 'Hera', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'College of Medicine, California Northstate University, Sacramento, CA 95757, USA.'}, {'ForeName': 'Waqas', 'Initials': 'W', 'LastName': 'Burney', 'Affiliation': 'Department of Biological Sciences, California State University, Sacramento, CA 90802, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Maloh', 'Affiliation': 'Department of Dermatology, University of California-Davis, Sacramento, CA 95816, USA.'}, {'ForeName': 'Raja K', 'Initials': 'RK', 'LastName': 'Sivamani', 'Affiliation': 'Department of Dermatology, University of California-Davis, Sacramento, CA 95816, USA.'}]",Nutrients,['10.3390/nu13030785'] 2403,33673568,Exploratory Efficacy of Calcium-Vitamin D Milk Fortification and Periodontal Therapy on Maternal Oral Health and Metabolic and Inflammatory Profile.,"In this 2 × 2 factorial, outcome-assessor blinded, feasibility randomised trial we explored the effect of a non-pharmaceutical multi-component intervention on periodontal health and metabolic and inflammatory profiles among pregnant women with periodontitis receiving prenatal care in a Brazilian public health centre. 69 pregnant women (gestational age ≤20 weeks, T0) were randomly allocated into four groups: (1) fortified sachet (vitamin D and calcium) and powdered milk plus periodontal therapy during pregnancy (early PT) ( n = 17); (2) placebo sachet and powdered milk plus early PT ( n = 15); (3) fortified sachet and powdered milk plus late PT (after delivery) ( n = 19); (4) placebo sachet and powdered milk plus late PT ( n = 18). Third trimester (T1) and 6-8 weeks postpartum (T2) exploratory outcomes included periodontal health (% sites with bleeding on probing (BOP)), glucose, insulin, C-Reactive Protein, serum calcium and vitamin D. The mean BOP was significantly reduced in the early PT groups, while BOP worsened in the late PT groups. No significant effect of fortification on BOP was observed. Changes in glucose levels and variation on birthweight did not differ among groups This feasibility trial provides preliminary evidence for estimating the minimum clinically important differences for selected maternal outcomes. A large-scale trial to evaluate the interventions' clinical benefits and cost-effectiveness is warranted.",2021,"The mean BOP was significantly reduced in the early PT groups, while BOP worsened in the late PT groups.","['69 pregnant women (gestational age ≤20 weeks, T0', 'pregnant women with periodontitis receiving prenatal care in a Brazilian public health centre']","['placebo sachet and powdered milk plus late PT', 'Calcium-Vitamin D Milk Fortification and Periodontal Therapy', 'non-pharmaceutical multi-component intervention', 'placebo sachet and powdered milk plus early PT ( n = 15); (3) fortified sachet and powdered milk plus late PT', 'fortified sachet (vitamin D and calcium) and powdered milk plus periodontal therapy during pregnancy (early PT']","['periodontal health and metabolic and inflammatory profiles', 'mean BOP', 'periodontal health (% sites with bleeding on probing (BOP)), glucose, insulin, C-Reactive Protein, serum calcium and vitamin D', 'BOP', 'Maternal Oral Health and Metabolic and Inflammatory Profile']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2348127', 'cui_str': 'Sachet - unit of product usage'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0719107', 'cui_str': 'Calcium and vitamin D product'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]",69.0,0.0645621,"The mean BOP was significantly reduced in the early PT groups, while BOP worsened in the late PT groups.","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Rodrigues Amorim Adegboye', 'Affiliation': 'Faculty of Health and Life Sciences, School of Nursing, Midwifery and Health, Coventry University, Priory Street, Coventry CV1 5FB, UK.'}, {'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'Dias Santana', 'Affiliation': 'Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, Rio de Janeiro 21941-902, Brazil.'}, {'ForeName': 'Pedro Paulo', 'Initials': 'PP', 'LastName': 'Teixeira Dos Santos', 'Affiliation': 'Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, Rio de Janeiro 21941-902, Brazil.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Guedes Cocate', 'Affiliation': 'Department of Bioscience and Physical Activity, School of Physical Education and Sports, Federal University of Rio de Janeiro, Rio de Janeiro 21941-599, Brazil.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Benaim', 'Affiliation': 'Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, Rio de Janeiro 21941-902, Brazil.'}, {'ForeName': 'Maria Beatriz', 'Initials': 'MB', 'LastName': 'Trindade de Castro', 'Affiliation': 'Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, Rio de Janeiro 21941-902, Brazil.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Maia Schlüssel', 'Affiliation': 'The EQUATOR Network-UK Centre, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Old Road, Oxford OX3 7LD, UK.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'Kac', 'Affiliation': 'Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, Rio de Janeiro 21941-902, Brazil.'}, {'ForeName': 'Berit', 'Initials': 'B', 'LastName': 'Lilienthal Heitmann', 'Affiliation': 'Research Unit for Dietary Studies at the Parker Institute, Bispebjerg and Frederiksberg Hospital, The Capital Region, 2000 Frederiksberg, Denmark.'}]",Nutrients,['10.3390/nu13030783'] 2404,33673567,Placebo Effect of Caffeine on Substrate Oxidation during Exercise.,"By using deceptive experiments in which participants are informed that they received caffeine when, in fact, they received an inert substance (i.e., placebo), several investigations have demonstrated that exercise performance can be enhanced to a similar degree as a known caffeine dose. This 'placebo effect' phenomenon may be part of the mechanisms explaining caffeine's ergogenicity in exercise. However, there is no study that has established whether the placebo effect of caffeine is also present for other benefits obtained with acute caffeine intake, such as enhanced fat oxidation during exercise. Therefore, the aim of this investigation was to investigate the placebo effect of caffeine on fat oxidation during exercise. Twelve young men participated in a deceptive double-blind cross-over experiment. Each participant completed three identical trials consisting of a step incremental exercise test from 30 to 80% of V.O 2max . In the two first trials, participants ingested either 3 mg/kg of cellulose (placebo) or 3 mg/kg of caffeine (received caffeine) in a randomized order. In the third trial, participants were informed that they had received 3 mg/kg of caffeine, but a placebo was provided (informed caffeine). Fat oxidation rates were derived from stoichiometric equations. In received caffeine, participants increased their rate of fat oxidation over the values obtained with the placebo at 30%, 40%, 50%, and 60% of V.O 2max (all p < 0.050). In informed caffeine, participants increased their rate of fat oxidation at 30%, 40%, 50% 60%, and 70% of V.O 2max (all p < 0.050) over the placebo, while there were no differences between received versus informed caffeine. In comparison to placebo (0.32 ± 0.15 g/min), the rate of maximal fat oxidation was higher in received caffeine (0.44 ± 0.22 g/min, p = 0.045) and in informed caffeine (0.41 ± 0.20 g/min, p = 0.026) with no differences between received versus informed caffeine. However, the intensity at which maximal fat oxidation rate was obtained (i.e., Fat max ) was similar in placebo, received caffeine, and informed caffeine trials (42.5 ± 4.5, 44.2 ± 9.0, and 41.7 ± 10.5% of V.O 2max , respectively, p = 0.539). In conclusion, the expectancy of having received caffeine produced similar effects on fat oxidation rate during exercise than actually receiving caffeine. Therefore, the placebo effect of caffeine is also present for the benefits of acute caffeine intake on substrate oxidation during exercise and it may be used to enhance fat oxidation during exercise in participants while reducing any risks to health that this substance may have.",2021,"In comparison to placebo (0.32 ± 0.15 g/min), the rate of maximal fat oxidation was higher in received caffeine (0.44 ± 0.22 g/min, p = 0.045) and in informed caffeine (0.41 ± 0.20 g/min, p = 0.026) with no differences between received versus informed caffeine.",['Twelve young men participated in a deceptive double-blind cross-over experiment'],"['caffeine', 'cellulose (placebo', 'placebo', 'caffeine (received caffeine', 'Caffeine', 'Placebo']","['rate of fat oxidation', 'Fat oxidation rates', 'Substrate Oxidation', 'fat oxidation rate', 'rate of maximal fat oxidation', 'intensity at which maximal fat oxidation rate']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0007648', 'cui_str': 'Cellulose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",12.0,0.358221,"In comparison to placebo (0.32 ± 0.15 g/min), the rate of maximal fat oxidation was higher in received caffeine (0.44 ± 0.22 g/min, p = 0.045) and in informed caffeine (0.41 ± 0.20 g/min, p = 0.026) with no differences between received versus informed caffeine.","[{'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Gutiérrez-Hellín', 'Affiliation': 'Exercise and Sport Science, Faculty of Health Sciences, Universidad Francisco de Vitoria, 28223 Pozuelo, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ruiz-Moreno', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, 28692 Villanueva de la Cañada, Spain.'}, {'ForeName': 'Millán', 'Initials': 'M', 'LastName': 'Aguilar-Navarro', 'Affiliation': 'Exercise and Sport Science, Faculty of Health Sciences, Universidad Francisco de Vitoria, 28223 Pozuelo, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Muñoz', 'Affiliation': 'Exercise and Sport Science, Faculty of Health Sciences, Universidad Francisco de Vitoria, 28223 Pozuelo, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Varillas-Delgado', 'Affiliation': 'Faculty of Medicine, Universidad Francisco de Vitoria, 28223 Pozuelo, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Amaro-Gahete', 'Affiliation': 'Department of Medical Physiology, Faculty of Medicine, University of Granada, 18 Granada, Spain.'}, {'ForeName': 'Justin D', 'Initials': 'JD', 'LastName': 'Roberts', 'Affiliation': 'Cambridge Centre for Sport and Exercise Sciences, School of Psychology and Sport Science, Anglia Ruskin University, Cambridge CB1 1PT, UK.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Del Coso', 'Affiliation': 'Centre for Sport Studies, Rey Juan Carlos University, 28943 Fuenlabrada, Spain.'}]",Nutrients,['10.3390/nu13030782'] 2405,33675850,Health- and Vision-Related Quality of Life in a Randomized Controlled Trial Comparing Methotrexate and Mycophenolate Mofetil for Uveitis.,"PURPOSE To evaluate changes in health-related and vision-related quality of life (VRQoL) among patients with noninfectious uveitis who were treated with antimetabolites. DESIGN Secondary analysis of a randomized controlled trial. PARTICIPANTS Patients with noninfectious uveitis from India, the United States, Australia, Saudi Arabia, and Mexico. METHODS From 2013 through 2017, 216 participants were randomized to receive 25 mg weekly oral methotrexate or 1.5 g twice daily oral mycophenolate mofetil. Median changes in quality of life (QoL) were measured using Wilcoxon signed-rank tests, and differences between treatment groups were measured using linear mixed models, adjusting for baseline QoL score, age, gender, and site. Among Indian patients, VRQoL scores from a general scale (the National Eye Institute Visual Function Questionnaire [NEI-VFQ]) and a culturally specific scale (the Indian Visual Function Questionnaire [IND-VFQ]) were compared using Pearson correlation tests. MAIN OUTCOME MEASURES Vision-related QoL (NEI-VFQ and IND-VFQ) and health-related QoL (HRQoL; physical component score [PCS] and mental component score [MCS] of the Medical Outcomes Study 36-Item Short Form Survey [SF-36v2]) were measured at baseline, the primary end point (6 months or treatment failure before 6 months), and the secondary end point (12 months or treatment failure between 6 and 12 months). RESULTS Among 193 participants who reached the primary end point, VRQoL increased from baseline by a median of 12.0 points (interquartile range [IQR], 1.0-26.1, NEI-VFQ scale), physical HRQoL increased by a median of 3.6 points (IQR, -1.4 to 14.9, PCS SF-36v2), and mental HRQoL increased by a median of 3.0 points (IQR, -3.7 to 11.9, MCS SF-36v2). These improvements in NEI-VFQ, SF-36v2 PCS, and SF-36v2 MCS scores all were significant (P < 0.01). The linear mixed models showed that QoL did not differ between treatment groups for each QoL assessment (NEI-VFQ, IND-VFQ, PCS SF-36v2, and MCS SF-36v2; P > 0.05 for all). The NEI-VFQ and IND-VFQ scores for Indian participants were correlated highly at baseline and the primary and secondary end points (correlation coefficients, 0.87, 0.80, and 0.90, respectively). CONCLUSIONS Among patients treated with methotrexate or mycophenolate mofetil for uveitis, VRQoL and HRQoL improved significantly over the course of 1 year and did not differ by treatment allocation. These findings suggest that antimetabolites could improve overall patient well-being and daily functioning.",2021,"The linear mixed models showed that QoL did not differ between treatment groups for each QoL assessment (NEI-VFQ, IND-VFQ, PCS SF-36v2, and MCS SF-36v2; p > 0.05 for all).","['193 participants', 'From 2013-2017', 'Patients with noninfectious uveitis from India, the United States, Australia, Saudi Arabia, and Mexico', 'patients with noninfectious uveitis who were treated with antimetabolites', 'Uveitis', '216 participants']","['mycophenolate mofetil', 'Methotrexate and Mycophenolate Mofetil', 'oral methotrexate', 'methotrexate or mycophenolate mofetil']","['uveitis, vision-related and health-related QoL', 'vision-related QoL scores', 'Vision-related (NEI-VFQ and IND-VFQ) and health-related (PCS (physical component score) and MCS (mental component score) SF-36v2) QoL', 'health-related and vision-related quality of life (QoL', 'vision-related QoL', 'NEI-VFQ, SF-36v2 PCS, and SF-36v2 MCS scores', 'NEI-VFQ and IND-VFQ scores', 'Health and Vision-Related Quality of Life', 'overall patient well-being and daily functioning', 'physical health-related QoL', 'Median changes in QoL', 'mental health-related QoL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0003376', 'cui_str': 'Antimetabolite'}, {'cui': 'C4708905', 'cui_str': '216'}]","[{'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1955969', 'cui_str': 'National Eye Institute'}, {'cui': 'C0013230', 'cui_str': 'Investigational New Drugs'}, {'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0036221', 'cui_str': 'Mast cell sarcoma'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",216.0,0.171623,"The linear mixed models showed that QoL did not differ between treatment groups for each QoL assessment (NEI-VFQ, IND-VFQ, PCS SF-36v2, and MCS SF-36v2; p > 0.05 for all).","[{'ForeName': 'Nicole K', 'Initials': 'NK', 'LastName': 'Kelly', 'Affiliation': 'F. I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Aheli', 'Initials': 'A', 'LastName': 'Chattopadhyay', 'Affiliation': 'F. I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Rathinam', 'Affiliation': 'Uvea Services, Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology, Madurai, India.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Gonzales', 'Affiliation': 'F. I. Proctor Foundation, University of California, San Francisco, San Francisco, California; Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Radhika', 'Initials': 'R', 'LastName': 'Thundikandy', 'Affiliation': 'Uvea Services, Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology, Madurai, India.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Kanakath', 'Affiliation': 'Uvea Services, Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology, Coimbatore, India.'}, {'ForeName': 'S Bala', 'Initials': 'SB', 'LastName': 'Murugan', 'Affiliation': 'Uvea Services, Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology, Pondicherry, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Vedhanayaki', 'Affiliation': 'Uvea Services, Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology, Madurai, India.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Cugley', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, Australia.'}, {'ForeName': 'Lyndell L', 'Initials': 'LL', 'LastName': 'Lim', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, Australia.'}, {'ForeName': 'Eric B', 'Initials': 'EB', 'LastName': 'Suhler', 'Affiliation': ""Casey Eye Institute, Oregon Health and Science University, OHSU-PSU School of Public Health, and Portland Veterans' Affairs Health Care System, Portland, Oregon.""}, {'ForeName': 'Hassan A', 'Initials': 'HA', 'LastName': 'Al-Dhibi', 'Affiliation': 'Division of Vitreoretinal Surgery and Uveitis, King Khaled Eye Specialist Hospital, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Caleb D', 'Initials': 'CD', 'LastName': 'Ebert', 'Affiliation': 'F. I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Elyse J', 'Initials': 'EJ', 'LastName': 'Berlinberg', 'Affiliation': 'F. I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'F. I. Proctor Foundation, University of California, San Francisco, San Francisco, California; Department of Ophthalmology, University of California, San Francisco, San Francisco, California; Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Nisha R', 'Initials': 'NR', 'LastName': 'Acharya', 'Affiliation': 'F. I. Proctor Foundation, University of California, San Francisco, San Francisco, California; Department of Ophthalmology, University of California, San Francisco, San Francisco, California; Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California. Electronic address: nisha.acharya@ucsf.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2021.02.024'] 2406,33682678,An open label trial of anakinra to prevent respiratory failure in COVID-19.,"Background It was studied if early suPAR-guided anakinra treatment can prevent severe respiratory failure (SRF) of COVID-19. Methods A total of 130 patients with suPAR ≥6 ng/ml were assigned to subcutaneous anakinra 100 mg once daily for 10 days. Primary outcome was SRF incidence by day 14 defined as any respiratory ratio below 150 mmHg necessitating mechanical or non-invasive ventilation. Main secondary outcomes were 30-day mortality and inflammatory mediators; 28-day WHO-CPS was explored. Propensity-matched standard-of care comparators were studied. Results 22.3% with anakinra treatment and 59.2% comparators (hazard ratio, 0.30; 95% CI, 0.20-0.46) progressed into SRF; 30-day mortality was 11.5% and 22.3% respectively (hazard ratio 0.49; 95% CI 0.25-0.97). Anakinra was associated with decrease in circulating interleukin (IL)-6, sCD163 and sIL2-R; IL-10/IL-6 ratio on day 7 was inversely associated with SOFA score; patients were allocated to less severe WHO-CPS strata. Conclusions Early suPAR-guided anakinra decreased SRF and restored the pro-/anti-inflammatory balance. Funding This study was funded by the Hellenic Institute for the Study of Sepsis, Technomar Shipping Inc, Swedish Orphan Biovitrum, and the Horizon 2020 Framework Programme. Clinical trial number NCT04357366.",2021,"Anakinra was associated with decrease in circulating interleukin (IL)-6, sCD163 and sIL2-R; IL-10/IL-6 ratio on day 7 was inversely associated with SOFA score; patients were allocated to less severe WHO-CPS strata. ",['130 patients with suPAR ≥6 ng/ml'],['subcutaneous anakinra'],"['circulating interleukin (IL)-6, sCD163 and sIL2-R; IL-10/IL-6 ratio', '30-day mortality and inflammatory mediators; 28-day WHO-CPS', 'SRF; 30-day mortality', 'SRF incidence by day 14 defined as any respiratory ratio below 150 mmHg necessitating mechanical or non-invasive ventilation']","[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0149958', 'cui_str': 'Partial Seizures, Complex'}, {'cui': 'C0037668', 'cui_str': 'Somatotropin releasing factor'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0429743', 'cui_str': 'Respiratory ratio'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}]",130.0,0.399825,"Anakinra was associated with decrease in circulating interleukin (IL)-6, sCD163 and sIL2-R; IL-10/IL-6 ratio on day 7 was inversely associated with SOFA score; patients were allocated to less severe WHO-CPS strata. ","[{'ForeName': 'Evdoxia', 'Initials': 'E', 'LastName': 'Kyriazopoulou', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Periklis', 'Initials': 'P', 'LastName': 'Panagopoulos', 'Affiliation': '2nd Department of Internal Medicine, Democritus University of Thrace, Medical School, Alexandroupolis, Greece.'}, {'ForeName': 'Symeon', 'Initials': 'S', 'LastName': 'Metallidis', 'Affiliation': '1st Department of Internal Medicine, Aristotle University ofThessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'George N', 'Initials': 'GN', 'LastName': 'Dalekos', 'Affiliation': 'Department of Medicine and Research Laboratory of Internal Medicine, National Expertise Center of Greece in Autoimmune Liver Diseases, General University Hospital of Larissa, Larissa, Greece.'}, {'ForeName': 'Garyphallia', 'Initials': 'G', 'LastName': 'Poulakou', 'Affiliation': '3rd Department of Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Gatselis', 'Affiliation': 'Department of Medicine and Research Laboratory of Internal Medicine, National Expertise Center of Greece in Autoimmune Liver Diseases, General University Hospital of Larissa, Larissa, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Karakike', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Saridaki', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Loli', 'Affiliation': '1st Department of Internal Medicine, Aristotle University ofThessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Aggelos', 'Initials': 'A', 'LastName': 'Stefos', 'Affiliation': 'Department of Medicine and Research Laboratory of Internal Medicine, National Expertise Center of Greece in Autoimmune Liver Diseases, General University Hospital of Larissa, Larissa, Greece.'}, {'ForeName': 'Danai', 'Initials': 'D', 'LastName': 'Prasianaki', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Georgiadou', 'Affiliation': 'Department of Medicine and Research Laboratory of Internal Medicine, National Expertise Center of Greece in Autoimmune Liver Diseases, General University Hospital of Larissa, Larissa, Greece.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Tsachouridou', 'Affiliation': '1st Department of Internal Medicine, Aristotle University ofThessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Vasileios', 'Initials': 'V', 'LastName': 'Petrakis', 'Affiliation': '2nd Department of Internal Medicine, Democritus University of Thrace, Medical School, Alexandroupolis, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Tsiakos', 'Affiliation': '3rd Department of Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kosmidou', 'Affiliation': '1st Department of Internal Medicine,University of Ioannina, School of HealthSciences, Faculty of Medicine, Ioannina, Greece.'}, {'ForeName': 'Vassiliki', 'Initials': 'V', 'LastName': 'Lygoura', 'Affiliation': 'Department of Medicine and Research Laboratory of Internal Medicine, National Expertise Center of Greece in Autoimmune Liver Diseases, General University Hospital of Larissa, Larissa, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Dareioti', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Haralampos', 'Initials': 'H', 'LastName': 'Milionis', 'Affiliation': '1st Department of Internal Medicine,University of Ioannina, School of HealthSciences, Faculty of Medicine, Ioannina, Greece.'}, {'ForeName': 'Ilias C', 'Initials': 'IC', 'LastName': 'Papanikolaou', 'Affiliation': 'Department of Pulmonary Medicine, General Hospital of Kerkyra, Kerkyra, Greece.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Akinosoglou', 'Affiliation': 'Department of Internal Medicine, University of Patras, Medical School, Rion, Greece.'}, {'ForeName': 'Dimitra-Melia', 'Initials': 'DM', 'LastName': 'Myrodia', 'Affiliation': '3rd Department of Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Areti', 'Initials': 'A', 'LastName': 'Gravvani', 'Affiliation': '3rd Department of Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Aliki', 'Initials': 'A', 'LastName': 'Stamou', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Theologia', 'Initials': 'T', 'LastName': 'Gkavogianni', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Konstantina', 'Initials': 'K', 'LastName': 'Katrini', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Theodoros', 'Initials': 'T', 'LastName': 'Marantos', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Ioannis P', 'Initials': 'IP', 'LastName': 'Trontzas', 'Affiliation': '3rd Department of Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Syrigos', 'Affiliation': '3rd Department of Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Loukas', 'Initials': 'L', 'LastName': 'Chatzis', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Stamatios', 'Initials': 'S', 'LastName': 'Chatzis', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Vechlidis', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Avgoustou', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Stamatios', 'Initials': 'S', 'LastName': 'Chalvatzis', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Miltiades', 'Initials': 'M', 'LastName': 'Kyprianou', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Jos Wm', 'Initials': 'JW', 'LastName': 'van der Meer', 'Affiliation': 'Department of Internal Medicine and Center for Infectious Diseases, Radboud University, Nijmegen, Netherlands.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Eugen-Olsen', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Mihai G', 'Initials': 'MG', 'LastName': 'Netea', 'Affiliation': 'Department of Internal Medicine and Center for Infectious Diseases, Radboud University, Nijmegen, Netherlands.'}, {'ForeName': 'Evangelos J', 'Initials': 'EJ', 'LastName': 'Giamarellos-Bourboulis', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}]",eLife,['10.7554/eLife.66125'] 2407,33684925,Brentuximab Vedotin in Combination with Chemotherapy for Pediatric Patients with ALK+ALCL: Results of COG Trial ANHL12P1.,"Approximately 30% of pediatric patients with ALCL relapse. While brentuximab vendotin has demonstrated excellent activity in ALCL, it has not been used for newly diagnosed patients. Children's Oncology Group trial ANHL12P1 determined the toxicity and efficacy of brentuximab vedotin with chemotherapy in children with newly diagnosed, non-localized, ALK+/CD30+ ALCL. From 2013 to 2017, 68 children with ALK+ ALCL were enrolled and received brentuximab vedotin (Arm BV). All patients received five-day prophase followed by six cycles of chemotherapy at 21-day intervals. Brentuximab vedotin was given on day 1 of each of the six cycles. Of the 67 eligible patients for toxicity evaluation, 66 completed all six cycles of chemotherapy resulting in 399 cycles evaluable. There were no toxic deaths, no cases of progressive multifocal leukoencephalopathy syndrome, and no cases of grade 3 or 4 neuropathy. The two-year EFS is 79.1% (95% CI, 67.2% to 87.1%). The two-year OS is 97.0% (95% CI, 88.1% to 99.2%). Fourteen patients relapsed and were the only events contributing to EFS. 11 of 14 (79%) relapses occurred within ten months of initial diagnosis, with only one patient (1.5%) having relapsed during therapy. Quantitative RT-PCR for NPM-ALK at baseline (minimal disseminated disease) demonstrated prognostic value and impacted 2-year EFS (P=0.0004). Overall, the addition of brentuximab vedotin to standard chemotherapy does not add significant toxicity, nor does it alter the desired interval between cycles. The addition of brentuximab vedotin prevented relapses during therapy and the overall and event-free survival estimates compare favorably with results obtained using conventional chemotherapy.",2021,The addition of brentuximab vedotin prevented relapses during therapy and the overall and event-free survival estimates compare favorably with results obtained using conventional chemotherapy.,"['From 2013 to 2017, 68 children with ALK+ ALCL were enrolled and received', 'children with newly diagnosed, non-localized, ALK+/CD30+ ALCL', 'Pediatric Patients with ALK+ALCL', 'pediatric patients with ALCL relapse', '67 eligible patients for toxicity evaluation, 66 completed all six cycles of chemotherapy resulting in 399 cycles evaluable', 'newly diagnosed patients']","['Brentuximab vedotin', 'Brentuximab Vedotin in Combination with Chemotherapy', 'brentuximab vedotin', 'brentuximab vedotin with chemotherapy']","['progressive multifocal leukoencephalopathy syndrome', 'toxicity and efficacy', 'toxic deaths']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0206180', 'cui_str': 'Large cell anaplastic lymphoma'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}]","[{'cui': 'C2973446', 'cui_str': 'brentuximab vedotin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0023524', 'cui_str': 'Progressive multifocal leukoencephalopathy'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",68.0,0.0979265,The addition of brentuximab vedotin prevented relapses during therapy and the overall and event-free survival estimates compare favorably with results obtained using conventional chemotherapy.,"[{'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lowe', 'Affiliation': ""Children's Hospital of The King's Daughters, Norfolk, Virginia, United States.""}, {'ForeName': 'Anne F', 'Initials': 'AF', 'LastName': 'Reilly', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States.""}, {'ForeName': 'Megan S', 'Initials': 'MS', 'LastName': 'Lim', 'Affiliation': 'Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Gross', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Saguilig', 'Affiliation': ""Children's Oncology Group, Monrovia, California, United States.""}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Barkauskas', 'Affiliation': 'Keck School of Medicine of the University of Southern California, United States.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wu', 'Affiliation': 'Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Alexander', 'Affiliation': 'The Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Bollard', 'Affiliation': ""Children's National Health System, Washington, District of Columbia, United States.""}]",Blood,['10.1182/blood.2020009806'] 2408,33683939,Results of a Randomized Phase II Trial of Intense Androgen Deprivation Therapy prior to Radical Prostatectomy in Men with High-Risk Localized Prostate Cancer.,"PURPOSE This multicenter randomized phase 2 trial investigates the impact of intense androgen deprivation on radical prostatectomy pathologic response and radiographic and tissue biomarkers in localized prostate cancer (NCT02903368). MATERIALS AND METHODS Eligible patients had a Gleason score ≥4+3=7, PSA >20 ng/mL or T3 disease and lymph nodes <20 mm. In Part 1, patients were randomized 1:1 to apalutamide, abiraterone acetate, prednisone and leuprolide (AAPL) or abiraterone, prednisone, leuprolide (APL) for 6 cycles (1 cycle=28 days) followed by radical prostatectomy. Surgical specimens underwent central review. The primary end point was the rate of pathologic complete response or minimum residual disease (minimum residual disease, tumor ≤5 mm). Secondary end points included prostate specific antigen response, positive margin rate and safety. Magnetic resonance imaging and tissue biomarkers of pathologic outcomes were explored. RESULTS The study enrolled 118 patients at 4 sites. Median age was 61 years and 94% of patients had high risk disease. The combined pathologic complete response or minimum residual disease rate was 22% in the AAPL arm and 20% in the APL arm (difference: 1.5%; 1-sided 95% CI -11%, 14%; 1-sided p=0.4). No new safety signals were observed. There was low concordance and correlation between posttherapy magnetic resonance imaging assessed and pathologically assessed tumor volume. PTEN-loss, ERG positivity and presence of intraductal carcinoma were associated with extensive residual tumor. CONCLUSIONS Intense neoadjuvant hormone therapy in high-risk prostate cancer resulted in favorable pathologic responses (tumor < 5 mm) in 21% of patients. Pathologic responses were similar between treatment arms. Part 2 of this study will investigate the impact of adjuvant hormone therapy on biochemical recurrence.",2021,Pathologic responses were similar between treatment arms.,"['Men with High-Risk Localized Prostate Cancer', '118 patients at four sites', 'Median age was 61 years and 94% of patients had high-risk disease', 'Eligible patients had a Gleason score ≥4+3=7, PSA >20 ng/mL or T3 disease and lymph nodes <20 mm']","['intense androgen deprivation', 'Intense Androgen Deprivation Therapy Prior to Radical Prostatectomy', 'apalutamide, abiraterone acetate, prednisone, and leuprolide, (AAPL) or abiraterone, prednisone, leuprolide (APL', 'adjuvant hormone therapy']","['radical prostatectomy (RP) pathologic response and radiographic and tissue biomarkers', 'PTEN-loss, ERG positivity and presence of intraductal carcinoma', 'favorable pathologic responses', 'combined pCR or MRD rate', 'rate of pathologic complete response (pCR) or minimum residual disease (MRD, tumor ≤5 mm', 'PSA response, positive margin rate, and safety', 'biochemical recurrence', 'Pathologic responses']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332326', 'cui_str': 'Gleason grading system for prostatic cancer'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C4329353', 'cui_str': 'apalutamide'}, {'cui': 'C2607886', 'cui_str': 'Abiraterone acetate'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0085272', 'cui_str': 'Leuprolide'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]","[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1430988', 'cui_str': 'PTEN protein, human'}, {'cui': 'C0013867', 'cui_str': 'Electroretinography'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0007124', 'cui_str': 'Intraductal carcinoma, noninfiltrating'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumour'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",118.0,0.1364,Pathologic responses were similar between treatment arms.,"[{'ForeName': 'Rana R', 'Initials': 'RR', 'LastName': 'McKay', 'Affiliation': 'University of California San Diego, La Jolla, California.'}, {'ForeName': 'Wanling', 'Initials': 'W', 'LastName': 'Xie', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Huihui', 'Initials': 'H', 'LastName': 'Ye', 'Affiliation': 'University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Fennessy', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Zhenwei', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Rosina', 'Initials': 'R', 'LastName': 'Lis', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Calagua', 'Affiliation': 'University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Rathkopf', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Vincent P', 'Initials': 'VP', 'LastName': 'Laudone', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Bubley', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Einstein', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Peter K', 'Initials': 'PK', 'LastName': 'Chang', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Wagner', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'J Kellogg', 'Initials': 'JK', 'LastName': 'Parsons', 'Affiliation': 'University of California San Diego, La Jolla, California.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Preston', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Kilbridge', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Chang', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Atish D', 'Initials': 'AD', 'LastName': 'Choudhury', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Mark M', 'Initials': 'MM', 'LastName': 'Pomerantz', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Quoc-Dien', 'Initials': 'QD', 'LastName': 'Trinh', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Adam S', 'Initials': 'AS', 'LastName': 'Kibel', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Mary-Ellen', 'Initials': 'ME', 'LastName': 'Taplin', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}]",The Journal of urology,['10.1097/JU.0000000000001702'] 2409,33683919,Nivolumab and Ipilimumab as Maintenance Therapy in Extensive-Disease Small-Cell Lung Cancer: CheckMate 451.,"PURPOSE In extensive-disease small-cell lung cancer (ED-SCLC), response rates to first-line platinum-based chemotherapy are robust, but responses lack durability. CheckMate 451, a double-blind phase III trial, evaluated nivolumab plus ipilimumab and nivolumab monotherapy as maintenance therapy following first-line chemotherapy for ED-SCLC. METHODS Patients with ED-SCLC, Eastern Cooperative Oncology Group performance status 0-1, and no progression after ≤ 4 cycles of first-line chemotherapy were randomly assigned (1:1:1) to nivolumab 1 mg/kg plus ipilimumab 3 mg/kg once every 3 weeks for 12 weeks followed by nivolumab 240 mg once every 2 weeks, nivolumab 240 mg once every 2 weeks, or placebo for ≤ 2 years or until progression or unacceptable toxicity. Primary end point was overall survival (OS) with nivolumab plus ipilimumab versus placebo. Secondary end points were hierarchically tested. RESULTS Overall, 834 patients were randomly assigned. The minimum follow-up was 8.9 months. OS was not significantly prolonged with nivolumab plus ipilimumab versus placebo (hazard ratio [HR], 0.92; 95% CI, 0.75 to 1.12; P = .37; median, 9.2 v 9.6 months). The HR for OS with nivolumab versus placebo was 0.84 (95% CI, 0.69 to 1.02); the median OS for nivolumab was 10.4 months. Progression-free survival HRs versus placebo were 0.72 for nivolumab plus ipilimumab (95% CI, 0.60 to 0.87) and 0.67 for nivolumab (95% CI, 0.56 to 0.81). A trend toward OS benefit with nivolumab plus ipilimumab was observed in patients with tumor mutational burden ≥ 13 mutations per megabase. Rates of grade 3-4 treatment-related adverse events were nivolumab plus ipilimumab (52.2%), nivolumab (11.5%), and placebo (8.4%). CONCLUSION Maintenance therapy with nivolumab plus ipilimumab did not prolong OS for patients with ED-SCLC who did not progress on first-line chemotherapy. There were no new safety signals.",2021,"Progression-free survival HRs versus placebo were 0.72 for nivolumab plus ipilimumab (95% CI, 0.60 to 0.87) and 0.67 for nivolumab (95% CI, 0.56 to 0.81).","['Extensive-Disease Small-Cell Lung Cancer', '834 patients were randomly assigned', 'patients with tumor mutational burden ≥ 13 mutations per megabase', 'Patients with ED-SCLC, Eastern Cooperative Oncology Group performance status 0-1, and no progression after ≤ 4 cycles of first-line chemotherapy']","['nivolumab 1 mg/kg plus ipilimumab', 'placebo', 'nivolumab plus ipilimumab and nivolumab monotherapy', 'Nivolumab and Ipilimumab', 'nivolumab plus ipilimumab', 'nivolumab 240 mg once every 2 weeks, nivolumab 240 mg once every 2 weeks, or placebo']","['overall survival (OS', 'Progression-free survival HRs', 'OS', 'median OS']","[{'cui': 'C0278726', 'cui_str': 'Small cell lung cancer extensive stage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1533164', 'cui_str': 'Mb'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",834.0,0.434633,"Progression-free survival HRs versus placebo were 0.72 for nivolumab plus ipilimumab (95% CI, 0.60 to 0.87) and 0.67 for nivolumab (95% CI, 0.56 to 0.81).","[{'ForeName': 'Taofeek K', 'Initials': 'TK', 'LastName': 'Owonikoko', 'Affiliation': 'Winship Cancer Institute of Emory University, Atlanta, GA.'}, {'ForeName': 'Keunchil', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ramaswamy', 'Initials': 'R', 'LastName': 'Govindan', 'Affiliation': 'Alvin J Siteman Cancer Center at Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Ready', 'Affiliation': 'Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'Department of Thoracic Oncology, Airway Research Center North, German Center for Lung Research, LungClinic, Grosshansdorf, Germany.'}, {'ForeName': 'Solange', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'Oncology Department, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Shaker R', 'Initials': 'SR', 'LastName': 'Dakhil', 'Affiliation': 'Cancer Center of Kansas, Wichita, KS.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Navarro', 'Affiliation': ""Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.""}, {'ForeName': 'Jerónimo', 'Initials': 'J', 'LastName': 'Rodríguez-Cid', 'Affiliation': 'Centro Oncológico, Médica Sur-Instituto Nacional de Enfermedades Respiratorias, Mexico City, Mexico.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schenker', 'Affiliation': 'Centrul de Oncologie Sf Nectarie, Craiova, Romania.'}, {'ForeName': 'Jong-Seok', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Seoul National University Bundang Hospital, Seongnam, South Korea.'}, {'ForeName': 'Vanesa', 'Initials': 'V', 'LastName': 'Gutierrez', 'Affiliation': 'Hospital Regional Universitario de Málaga, Málaga, Spain.'}, {'ForeName': 'Ivor', 'Initials': 'I', 'LastName': 'Percent', 'Affiliation': 'Florida Cancer Specialists, Punta Gorda, FL.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Morgensztern', 'Affiliation': 'Alvin J Siteman Cancer Center at Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Carlos H', 'Initials': 'CH', 'LastName': 'Barrios', 'Affiliation': 'Oncology Research Center, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Porto Alegre, Brazil.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Greillier', 'Affiliation': 'Aix Marseille Univ, APHM, INSERM, CNRS, CRCM, Hôpital Nord, Multidisciplinary Oncology and Therapeutic Innovations Department, Marseille, France.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Baka', 'Affiliation': 'Interbalkan European Medical Center, Thessaloniki, Greece.'}, {'ForeName': 'Miten', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'Cancer Specialists of North Florida, Jacksonville, FL.'}, {'ForeName': 'Wen Hong', 'Initials': 'WH', 'LastName': 'Lin', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Selvaggi', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Baudelet', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Baden', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ.'}, {'ForeName': 'Dimple', 'Initials': 'D', 'LastName': 'Pandya', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Doshi', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ.'}, {'ForeName': 'Hye Ryun', 'Initials': 'HR', 'LastName': 'Kim', 'Affiliation': 'Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.02212'] 2410,33824629,THE IMPACT OF MEDICAID EXPANSION ON VOTER PARTICIPATION: EVIDENCE FROM THE OREGON HEALTH INSURANCE EXPERIMENT.,"In 2008, a group of uninsured low-income adults in Oregon was selected by lottery for the chance to apply for Medicaid. Using this randomized design and state administrative data on voter behavior, we analyze how a Medicaid expansion affected voter turnout and registration. We find that Medicaid increased voter turnout in the November 2008 Presidential election by about 7 percent overall, with the effects concentrated in men (18 percent increase) and in residents of Democratic counties (10 percent increase); there is suggestive evidence that the increase in voting reflected new voter registrations, rather than increased turnout among pre-existing registrants. There is no evidence of an increase in voter turnout in subsequent elections, up to and including the November 2010 midterm election.",2019,"There is no evidence of an increase in voter turnout in subsequent elections, up to and including the November 2010 midterm election.","['In 2008, a group of uninsured low-income adults in Oregon was selected by lottery for the chance to apply for Medicaid']",[],[],"[{'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0087134', 'cui_str': 'Uninsured'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029195', 'cui_str': 'Oregon'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}]",[],[],,0.0927463,"There is no evidence of an increase in voter turnout in subsequent elections, up to and including the November 2010 midterm election.","[{'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Baicker', 'Affiliation': 'University of Chicago, NBER, and J-PAL North America.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Finkelstein', 'Affiliation': 'NBER and J-PAL North America.'}]",Quarterly journal of political science,['10.1561/100.00019026'] 2411,33676295,Prognostic and predictive impact of consensus molecular subtypes and CRCAssigner classifications in metastatic colorectal cancer: a translational analysis of the TRIBE2 study.,"INTRODUCTION The consensus molecular subtypes (CMS) demonstrated prognostic value in metastatic colorectal cancer (mCRC). Similarly, a prognostic impact was suggested for the pre-consensus CRCAssigner (CRCA) classifier in early stages. The potential predictive role of these classifiers with regard to the choice of the first-line therapy has not been established. We investigated the prognostic and predictive impact of CMS and CRCA subtypes among mCRC patients treated in the TRIBE2 study. METHODS Among 679 randomized patients, 426 and 428 (63%) samples were profiled according to CMS and CRCA classifications, respectively. The prognostic and predictive impact of both CMS and CRCA subtypes was investigated with univariate and multivariate analyses for progression-free survival (PFS), PFS 2 (PFS2), and overall survival (OS). RESULTS Significant associations of CMS and CRCA subtypes with PFS, PFS2, and OS were demonstrated; the CMS classifier confirmed its independent prognostic value in the multivariable model (P value for PFS/PFS2/OS = 0.01/0.07/0.08). The effect of treatment intensification was independent of CMS subtypes (P value for interaction for PFS/PFS2/OS = 0.88/0.75/0.55). A significant interaction effect between CRCA subtypes and treatment arm was demonstrated in PFS (P = 0.02), PFS2 (P = 0.01), and OS (P = 0.008). The benefit of FOLFOXIRI seemed more relevant in the stem-like (PFS, hazard ratio = 0.60; P = 0.03) and mixed subtypes (hazard ratio = 0.44; P = 0.002). These findings were confirmed in a subgroup of patients of the previous TRIBE study. CONCLUSIONS We confirmed the independent prognostic role of CMS classification in mCRC independently of RAS/BRAF status. CRCA classification may help identifying subgroups of patients who may derive more benefit from FOLFOXIRI/bevacizumab.",2021,The effect of treatment intensification was independent of CMS subtypes (P value for interaction for PFS/PFS2/OS = 0.88/0.75/0.55).,"['mCRC patients treated in the TRIBE2 study', 'metastatic colorectal cancer (mCRC', 'Among 679 randomized patients, 426 and 428 (63', 'metastatic colorectal cancer']",['FOLFOXIRI/bevacizumab'],"['progression-free survival (PFS), PFS 2 (PFS2), and overall survival (OS', 'PFS2', 'PFS']","[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517775', 'cui_str': '428'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",679.0,0.0761612,The effect of treatment intensification was independent of CMS subtypes (P value for interaction for PFS/PFS2/OS = 0.88/0.75/0.55).,"[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Borelli', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, Unit of Medical Oncology, Azienda Ospedaliero-Universitaria Pisana, University of Pisa, Pisa, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Fontana', 'Affiliation': 'Division of Molecular Pathology, The Institute of Cancer Research, London, UK; Sarah Cannon Research Institute, London, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Giordano', 'Affiliation': 'Department of Surgical, Medical, Molecular Pathology and Critical Area, University of Pisa, Pisa, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Antoniotti', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, Unit of Medical Oncology, Azienda Ospedaliero-Universitaria Pisana, University of Pisa, Pisa, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Unit of Medical Oncology 1, Department of Oncology, Istituto Oncologico Veneto, IRCCS, Padua, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Bergamo', 'Affiliation': 'Unit of Medical Oncology 1, Department of Oncology, Istituto Oncologico Veneto, IRCCS, Padua, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Pietrantonio', 'Affiliation': 'Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy; Oncology and Hemato-Oncology Department, University of Milan, Milan, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Morano', 'Affiliation': 'Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Tamburini', 'Affiliation': 'Oncology Unit, Ospedale degli Infermi, Rimini, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Boccaccino', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, Unit of Medical Oncology, Azienda Ospedaliero-Universitaria Pisana, University of Pisa, Pisa, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Santini', 'Affiliation': 'Department of Medical Oncology, University Campus Biomedico, Rome, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Zucchelli', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, Unit of Medical Oncology, Azienda Ospedaliero-Universitaria Pisana, University of Pisa, Pisa, Italy.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Pella', 'Affiliation': 'Department of Oncology, University and General Hospital, Udine, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Maiello', 'Affiliation': 'Oncology Unit, Foundation IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Passardi', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCSS, Meldola, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zaniboni', 'Affiliation': 'Medical Oncology Unit, Fondazione Poliambulanza, Brescia, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ugolini', 'Affiliation': 'Unit of Pathological Anatomy, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Fontanini', 'Affiliation': 'Department of Surgical, Medical, Molecular Pathology and Critical Area, University of Pisa, Pisa, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, Unit of Medical Oncology, Azienda Ospedaliero-Universitaria Pisana, University of Pisa, Pisa, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Nyamundanda', 'Affiliation': 'Division of Molecular Pathology, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sadanandam', 'Affiliation': 'Division of Molecular Pathology, The Institute of Cancer Research, London, UK. Electronic address: anguraj.sadanandam@icr.ac.uk.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cremolini', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, Unit of Medical Oncology, Azienda Ospedaliero-Universitaria Pisana, University of Pisa, Pisa, Italy. Electronic address: chiaracremolini@gmail.com.'}]",ESMO open,['10.1016/j.esmoop.2021.100073'] 2412,33678522,Efficacy and Safety of Atezolizumab Plus Bevacizumab Following Disease Progression on Atezolizumab or Sunitinib Monotherapy in Patients with Metastatic Renal Cell Carcinoma in IMmotion150: A Randomized Phase 2 Clinical Trial.,"BACKGROUND The use of immune checkpoint inhibitors combined with vascular endothelial growth factor (VEGF)-targeted therapy as second-line treatment for metastatic clear cell renal cancer (mRCC) has not been evaluated prospectively. OBJECTIVE To evaluate the efficacy and safety of atezolizumab + bevacizumab following disease progression on atezolizumab or sunitinib monotherapy in patients with mRCC. DESIGN, SETTING, AND PARTICIPANTS IMmotion150 was a multicenter, randomized, open-label, phase 2 study of patients with untreated mRCC. Patients randomized to the atezolizumab or sunitinib arm who had investigator-assessed progression as per RECIST 1.1 could be treated with second-line atezolizumab + bevacizumab. INTERVENTION Patients received atezolizumab 1200 mg intravenously (IV) plus bevacizumab 15 mg/kg IV every 3 wk following disease progression on either atezolizumab or sunitinib monotherapy. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS The secondary endpoints analyzed during the second-line part of IMmotion150 included objective response rate (ORR), progression-free survival (PFS), and safety. PFS was examined using Kaplan-Meier methods. RESULTS AND LIMITATIONS Fifty-nine patients in the atezolizumab arm and 78 in the sunitinib arm were eligible, and 103 initiated second-line atezolizumab + bevacizumab (atezolizumab arm, n = 44; sunitinib arm, n = 59). ORR (95% confidence interval [CI]) was 27% (19-37%). The median PFS (95% CI) from the start of second line was 8.7 (5.6-13.7) mo. The median event follow-up duration was 19.4 (12.9-21.9) mo among the 25 patients without a PFS event. Eighty-six (83%) patients had treatment-related adverse events; 31 of 103 (30%) had grade 3/4 events. Limitations were the small sample size and selection for progressors. CONCLUSIONS The atezolizumab + bevacizumab combination had activity and was tolerable in patients with progression on atezolizumab or sunitinib. Further studies are needed to investigate sequencing strategies in mRCC. PATIENT SUMMARY Patients with advanced kidney cancer whose disease had worsened during treatment with atezolizumab or sunitinib began second-line treatment with atezolizumab + bevacizumab. Tumors shrank in more than one-quarter of patients treated with this combination, and side effects were manageable.",2021,The atezolizumab + bevacizumab combination had activity and was tolerable in patients with progression on atezolizumab or sunitinib.,"['patients with untreated mRCC', 'metastatic clear cell renal cancer (mRCC', 'Patients with advanced kidney cancer whose disease had worsened during treatment with atezolizumab or sunitinib began second-line treatment with', 'Patients with Metastatic Renal Cell Carcinoma in IMmotion150', 'patients with mRCC', 'arm, n\u2009=\u200944; sunitinib arm, n\u2009=\u200959', 'Fifty-nine patients in the atezolizumab arm and 78 in the sunitinib arm were eligible, and 103 initiated second-line', 'patients with progression on atezolizumab or sunitinib']","['atezolizumab\u2009+\u2009bevacizumab', 'atezolizumab 1200\u2009mg intravenously (IV) plus bevacizumab', 'atezolizumab or sunitinib', 'atezolizumab or sunitinib monotherapy', 'atezolizumab\u2009+\u2009bevacizumab (atezolizumab', 'Atezolizumab Plus Bevacizumab', 'vascular endothelial growth factor (VEGF)-targeted therapy']","['median event follow-up duration', 'ORR', 'median PFS', 'efficacy and safety', 'objective response rate (ORR), progression-free survival (PFS), and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0229473', 'cui_str': 'Cell of Claudius'}, {'cui': 'C0740457', 'cui_str': 'Malignant tumor of kidney'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1710038', 'cui_str': 'Second line treatment'}, {'cui': 'C4721698', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",25.0,0.135672,The atezolizumab + bevacizumab combination had activity and was tolerable in patients with progression on atezolizumab or sunitinib.,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Barts Cancer Institute, Queen Mary University of London, London, UK. Electronic address: Thomas.Powles@bartshealth.nhs.uk.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Atkins', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Washington, DC, USA.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Escudier', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Fong', 'Affiliation': 'University of California, San Francisco, School of Medicine, San Francisco, CA, USA.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Joseph', 'Affiliation': 'Mayo Clinic Hospital, Jacksonville, FL, USA.'}, {'ForeName': 'Sumanta K', 'Initials': 'SK', 'LastName': 'Pal', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Sznol', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hainsworth', 'Affiliation': 'Sarah Cannon Research Institute, Nashville, TN, USA.'}, {'ForeName': 'Walter M', 'Initials': 'WM', 'LastName': 'Stadler', 'Affiliation': 'The University of Chicago Medicine, Chicago, IL, USA.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Hutson', 'Affiliation': 'Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, TX, USA.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Ravaud', 'Affiliation': 'CHU Hopitaux de Bordeaux, Hôpital Saint-André, Bordeaux, France.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Bracarda', 'Affiliation': 'Azienda Ospedaliera S. Maria, Terni, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Suarez', 'Affiliation': ""Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Reeves', 'Affiliation': 'Florida Cancer Specialists & Research Institute, Fort Myers, FL, USA.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Cohn', 'Affiliation': 'Rocky Mountain Cancer Center, Denver, CO, USA.'}, {'ForeName': 'Beiying', 'Initials': 'B', 'LastName': 'Ding', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Leng', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Hashimoto', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'Mahrukh', 'Initials': 'M', 'LastName': 'Huseni', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Schiff', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'McDermott', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, MA, USA.'}]",European urology,['10.1016/j.eururo.2021.01.003'] 2413,33677189,Effect of liraglutide 3.0mg treatment on weight reduction in obese antipsychotic-treated patients.,"BACKGROUND Patients treated with antipsychotics experience significant weight gain and accompanying metabolic disorders. We investigated the efficacy of liraglutide 3.0 mg in reducing the weight of antipsychotic-treated obese patients. METHOD We retrospectively reviewed 16 obese patients with schizophrenia or bipolar disorder who were treated with 3.0 mg of liraglutide each. During the 16 weeks of treatment, changes in body weight and Clinical Global Impression-Severity scale (CGI-S) were analyzed. The participants were divided into responders (lost at least 5% of body weight) and non-responders for analysis. RESULTS Treatment with liraglutide 3.0 mg significantly decreased body weight (estimated marginal mean, 93.2 kg at baseline and 88.9 kg at 16 weeks; p < 0.001) as well as waist circumference, BMI and plasma glucose levels. Six of 16 patients (37.5%) complained of a modest degree of nausea. Six of the 12 subjects (50%) completing 16 weeks of treatment were responders. There were no significant differences in baseline characteristics between responders and non-responders. There was no worsening of CGI-S scores. CONCLUSION Liraglutide 3.0 mg significantly decreased body weight in obese patients treated with antipsychotics without altering the status of psychiatric diseases. A randomized controlled study is required to corroborate the results of this study.",2021,"During the 16 weeks of treatment, changes in body weight and Clinical Global Impression-Severity scale (CGI-S) were analyzed.","['16 obese patients with schizophrenia or bipolar disorder who were treated with 3.0 mg of liraglutide each', 'obese antipsychotic-treated patients', 'treated obese patients', 'Patients treated with antipsychotics experience significant weight gain and accompanying metabolic disorders', 'obese patients treated with']","['liraglutide', 'Liraglutide', 'antipsychotics']","['weight reduction', 'weight of antipsychotic', 'changes in body weight and Clinical Global Impression-Severity scale (CGI-S', 'body weight', 'nausea', 'CGI-S scores', 'waist circumference, BMI and plasma glucose levels']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0025517', 'cui_str': 'Metabolic disease'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",16.0,0.0244782,"During the 16 weeks of treatment, changes in body weight and Clinical Global Impression-Severity scale (CGI-S) were analyzed.","[{'ForeName': 'Seung Eun', 'Initials': 'SE', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Dongguk University Ilsan Hospital, Goyang, Gyeonggi-do, South Korea.'}, {'ForeName': 'Nam Young', 'Initials': 'NY', 'LastName': 'Lee', 'Affiliation': 'Department of Neuropsychiatry, Dongguk University Ilsan Hospital, Goyang, Gyeonggi-do, South Korea.'}, {'ForeName': 'Se Hyun', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Kyoung-Ah', 'Initials': 'KA', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Dongguk University Ilsan Hospital, Goyang, Gyeonggi-do, South Korea.'}, {'ForeName': 'Yong Sik', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Nowon Eulji Hospital, Eulji University College of Medicine, Seoul, South Korea; Institute of Clinical Psychopharmacology, Dongguk University College of Medicine, Goyang, Gyeonggi-do, South Korea. Electronic address: kys@snu.ac.kr.'}]",Psychiatry research,['10.1016/j.psychres.2021.113830'] 2414,33682358,"Pharmacokinetics, safety, and immunogenicity of HLX03, an adalimumab biosimilar, compared with reference biologic in healthy Chinese male volunteers: Results of a randomized, double-blind, parallel-controlled, phase 1 study.","The primary objective of this randomized, double-blind, parallel-controlled study (from December 2016 to October 2018) was to evaluate pharmacokinetic (PK) equivalence of adalimumab biosimilar HLX03 and reference adalimumab in healthy volunteers, and to assess safety, and immunogenicity of HLX03. The primary PK endpoints were maximum observed plasma concentration (C max ) and area under the concentration curve from time zero to the last quantifiable concentration (AUC 0-t ). Equivalence was determined if the 90% confidence interval (CI) of geometric least square mean ratio between the two treatment groups were within the predefined range of 80%-125%. Safety and immunogenicity were monitored during the study. Healthy Chinese males (N = 220) were randomized 1:1 to receive a single subcutaneous 40 mg dose of HLX03 or China (CN)-sourced adalimumab. The ratios of the geometric mean of C max and AUC 0-t were 102.2% and 105.7%, respectively, with corresponding 90% CIs falling in the predefined margins, which demonstrated PK equivalence between HLX03 and CN-adalimumab. The incidence of treatment-emergent adverse events (TEAEs) was similar in the two groups (73.8% and 66.0% in the HLX03 and CN-adalimumab groups, respectively). Grade 3-4 TEAEs were reported in 7.5% and 5.7% of participants, respectively. The incidences of participants with antidrug antibodies (HLX03: 96.2%; CN-adalimumab: 93.4%) or neutralizing antibodies (HLX03: 40.6%, CN-adalimumab: 41.4%) were comparable between groups. This study demonstrated PK bioequivalence between HLX03 and CN-adalimumab, with similar safety and immunogenicity profiles. These data support further clinical development of HLX03 as an adalimumab biosimilar.",2021,"The incidence of treatment-emergent adverse events (TEAEs) was similar in the two groups (73.8% and 66.0% in the HLX03 and CN-adalimumab groups, respectively).","['Healthy Chinese males (N\xa0=\xa0220', 'healthy Chinese male volunteers', 'healthy volunteers', 'December 2016 to October 2018']","['adalimumab biosimilar HLX03 and reference adalimumab', 'HLX03 and CN-adalimumab', 'single subcutaneous 40\xa0mg dose of HLX03 or China (CN)-sourced adalimumab']","['confidence interval (CI) of geometric least square mean ratio', 'safety, and immunogenicity of HLX03', 'Safety and immunogenicity', 'ratios of the geometric mean of C max and AUC 0-t', 'maximum observed plasma concentration (C max ) and area under the concentration curve from time zero to the last quantifiable concentration (AUC 0-t ', 'Pharmacokinetics, safety, and immunogenicity of HLX03', 'pharmacokinetic (PK) equivalence', 'incidence of treatment-emergent adverse events (TEAEs']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0449416', 'cui_str': 'Source'}]","[{'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",4.0,0.268403,"The incidence of treatment-emergent adverse events (TEAEs) was similar in the two groups (73.8% and 66.0% in the HLX03 and CN-adalimumab groups, respectively).","[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Phase 1 Clinical Research Center, the First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Phase 1 Clinical Research Center, the First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Jixuan', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Phase 1 Clinical Research Center, the First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Xiaoxue', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Phase 1 Clinical Research Center, the First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Cuiyun', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Phase 1 Clinical Research Center, the First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Phase 1 Clinical Research Center, the First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Xiaodi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Henlius Biotech, Inc., Shanghai, China.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Chai', 'Affiliation': 'Shanghai Henlius Biotech, Inc., Shanghai, China.'}, {'ForeName': 'Xiaojiao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Phase 1 Clinical Research Center, the First Hospital of Jilin University, Changchun, China.'}]",Pharmacology research & perspectives,['10.1002/prp2.733'] 2415,33682145,"Effects of acetate on cerebral blood flow, systemic inflammation, and behavior in alcohol use disorder.","BACKGROUND Alcohol use disorders (AUDs) are associated with altered regulation of physiological processes in the brain. Acetate, a metabolite of ethanol, has been implicated in several processes that are disrupted in AUDs including transcriptional regulation, metabolism, inflammation, and neurotransmission. To further understand the effects of acetate on brain function in AUDs, we investigated the effects of acetate on cerebral blood flow (CBF), systemic inflammatory cytokines, and behavior in AUD. METHODS Sixteen participants with AUD were recruited from a nonmedical, clinically managed detoxification center. Each participant received acetate and placebo in a randomly assigned order of infusion and underwent 3T MR scanning using quantitative pseudo-continuous arterial spin labeling. Participants and the study team were blinded to the infusion. CBF values (ml/100 g/min) extracted from thalamus were compared between placebo and acetate using a mixed effect linear regression model accounting for infusion order. Voxel-wise CBF comparisons were set at threshold of p < 0.05 cluster-corrected for multiple comparisons, voxel-level p < 0.0001. Plasma cytokine levels and behavior were also assessed between infusions. RESULTS Fifteen men and 1 woman were enrolled with Alcohol Use Disorders Identification Test (AUDIT) scores between 13 and 38 with a mean of 28.3 ± 9.1. Compared to placebo, acetate administration increased CBF in the thalamus bilaterally (Left: 51.2 vs. 68.8, p < 0.001; Right: 53.7 vs. 69.6, p = 0.001), as well as the cerebellum, brainstem, and cortex. Older age and higher AUDIT scores were associated with increases in acetate-induced thalamic blood flow. Cytokine levels and behavioral measures did not differ between placebo and acetate infusions. CONCLUSIONS This pilot study in AUD suggests that during the first week of abstinence from alcohol, the brain's response to acetate differs by brain region and this response may be associated with the severity of alcohol dependence.",2021,"Compared to placebo, acetate administration increased CBF in the thalamus bilaterally (Left: 51.2 vs. 68.8, p<0.001; Right: 53.7 vs. 69.6, p=0.001), as well as the cerebellum, brainstem, and cortex.","['Sixteen participants with AUD were recruited from a non-medical, clinically-managed detoxification center', 'Fifteen men and one woman were enrolled with Alcohol Use Disorders Identification Test (AUDIT) scores between 13 and 38 with a mean of 28.3 ± 9.1']","['Acetate', 'placebo, acetate', 'placebo', '3T MR scanning using quantitative pseudo-continuous arterial spin labeling', 'acetate and placebo']","['acetate-induced thalamic blood flow', 'CBF', 'Cytokine levels and behavioral measures', 'Plasma cytokine levels and behavior', 'Cerebral blood flow (CBF) values', 'Cerebral Blood Flow, Systemic Inflammation, and Behavior in Alcohol Use Disorder', 'cerebral blood flow, systemic inflammatory cytokines, and behavior in AUD']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0025516', 'cui_str': 'Detoxication, Drug, Metabolic'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1097281', 'cui_str': '3-(3,4-dimethoxyphenyl)-1H-1,2,4-triazole'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0205237', 'cui_str': 'False'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}]","[{'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}]",16.0,0.103136,"Compared to placebo, acetate administration increased CBF in the thalamus bilaterally (Left: 51.2 vs. 68.8, p<0.001; Right: 53.7 vs. 69.6, p=0.001), as well as the cerebellum, brainstem, and cortex.","[{'ForeName': 'Jody', 'Initials': 'J', 'LastName': 'Tanabe', 'Affiliation': 'Department of Radiology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Neff', 'Affiliation': 'Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Brianne', 'Initials': 'B', 'LastName': 'Sutton', 'Affiliation': 'Department of Psychiatry, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Ellis', 'Affiliation': 'Department of Pharmaceutical Sciences, School of Pharmacy, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Patten', 'Affiliation': 'Department of Biostatistics and Informatics, School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Brown', 'Affiliation': 'Department of Radiology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Paula L', 'Initials': 'PL', 'LastName': 'Hoffman', 'Affiliation': 'Department of Pharmacology, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Tabakoff', 'Affiliation': 'Department of Pharmaceutical Sciences, School of Pharmacy, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Ellen L', 'Initials': 'EL', 'LastName': 'Burnham', 'Affiliation': 'Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14588'] 2416,33686119,Patent ductus arteriosus shunt elimination results in a reduction in adverse outcomes: a post hoc analysis of the PDA RCT cohort.,"OBJECTIVE A post hoc appraisal of the PDA RCT to assess the relationship between early patent ductus arteriosus (PDA) shunt elimination and chronic lung disease or death (CLD/Death). STUDY DESIGN Infants <29 weeks were divided into four groups: intervention arm in whom PDA closure was achieved (n = 17); intervention arm in whom PDA closure was not achieved (n = 13); placebo arm (n = 30); low risk infants (n = 13). The main outcome measure was CLD/Death. RESULTS The rates of CLD/Death were lower in the Intervention Success Group (29%) when compared to the Intervention Failure Group (85%) or the Placebo Group (60%, all p < 0.05). There was no difference in CLD/Death between the Intervention Success and Low Risk Groups (8%, p > 0.05). A persistent PDA beyond Day 8 was associated with CLD/Death (aOR 6.5 [1.7-25.5]). CONCLUSIONS Early shunt elimination in preterm infants with a PDA may reduce respiratory morbidity when compared to infants with prolonged shunt exposure.",2021,"The rates of CLD/Death were lower in the Intervention Success Group (29%) when compared to the Intervention Failure Group (85%) or the Placebo Group (60%, all p < 0.05).","['Infants <29 weeks', 'preterm infants with a PDA']","['PDA RCT', 'Placebo', 'placebo']","['rates of CLD/Death', 'adverse outcomes', 'respiratory morbidity', 'CLD/Death']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}]","[{'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0746102', 'cui_str': 'Chronic lung disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1301752', 'cui_str': 'Respiratory morbidity'}]",,0.136275,"The rates of CLD/Death were lower in the Intervention Success Group (29%) when compared to the Intervention Failure Group (85%) or the Placebo Group (60%, all p < 0.05).","[{'ForeName': 'Neidín', 'Initials': 'N', 'LastName': 'Bussmann', 'Affiliation': 'Department of Neonatology, The Rotunda Hospital, Dublin, Ireland.'}, {'ForeName': 'Aisling', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Department of Neonatology, The Rotunda Hospital, Dublin, Ireland.'}, {'ForeName': 'Colm R', 'Initials': 'CR', 'LastName': 'Breatnach', 'Affiliation': 'Department of Neonatology, The Rotunda Hospital, Dublin, Ireland.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'McCallion', 'Affiliation': 'Department of Neonatology, The Rotunda Hospital, Dublin, Ireland.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Cleary', 'Affiliation': 'Department of Pharmacy, The Rotunda Hospital, Dublin, Ireland.'}, {'ForeName': 'Orla', 'Initials': 'O', 'LastName': 'Franklin', 'Affiliation': ""Department of Paediatric Cardiology, Our Lady's Children's Hospital Crumlin, Dublin, Ireland.""}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'McNamara', 'Affiliation': ""Division of Neonatology, Stead Family Children's Hospital, Iowa City, IA, USA.""}, {'ForeName': 'Afif', 'Initials': 'A', 'LastName': 'El-Khuffash', 'Affiliation': 'Department of Neonatology, The Rotunda Hospital, Dublin, Ireland. afifelkhuffash@rcsi.com.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-021-01002-z'] 2417,33685795,Effects of increased physical activity and/or weight loss diet on serum myokine and adipokine levels in overweight adults with impaired glucose metabolism.,"AIM The purpose of this study was to investigate the changes in serum irisin, fibroblast growth factor-21 (FGF21), visfatin, follistatin like protein-1 (FSTL1), and meteorin-like protein (Metrnl) levels in response to increased physical activity and/or diet interventions in overweight subjects with impaired glucose metabolism (IGM). METHODS A total of 60 subjects (BMI > 25.0 kg/m 2 ) with IGM were recruited in this single-centered interventional study. Twelve subjects dropped out during the study and the study was completed with 48 patients. Patients were divided into two groups as diet only (DI, n = 24) and diet and physical activity intervention (DPA, n = 24). Patients in DI group received a diet program while DPA group received a diet combined with a physical activity intervention for 12 weeks. Additional 24 healthy subjects were recruited to compare the baseline levels of proteins. Serum protein levels, anthropometric measurements, and biochemical parameters were assessed. RESULTS Irisin, FGF21, visfatin, and FSTL1 levels significantly decreased in both groups after 12-week intervention (p < 0.001). However, there were no differences in protein levels between DI and DPA groups (p > 0.05). Likewise, the total change in weight was similar in both DI (-4.35 kg) and DPA (-4.85 kg) groups (p > 0.05). A 5% reduction in initial body weight with DPA therapy resulted in a stronger correlation between the changes in irisin, visfatin, and FSTL1 levels and fasting glucose and HbA1c levels. CONCLUSIONS These results demonstrate that serum irisin, FGF21, visfatin, and FSTL1 levels decreased in response to weight loss interventions. Weight loss induced by DI or DPA therapies had similar lowering effects on these proteins in subjects with IGM, and these myokines might be related to glucose metabolism biomarkers.",2021,"RESULTS Irisin, FGF21, visfatin, and FSTL1 levels significantly decreased in both groups after 12-week intervention (p < 0.001).","['overweight subjects with impaired glucose metabolism (IGM', 'Twelve subjects dropped out during the study and the study was completed with 48 patients', 'overweight adults with impaired glucose metabolism', 'Additional 24 healthy subjects', '60 subjects (BMI\u202f>\u202f25.0\u202fkg/m 2 ) with IGM']","['diet and physical activity intervention', 'physical activity and/or weight loss diet', 'diet program while DPA group received a diet combined with a physical activity intervention']","['serum myokine and adipokine levels', 'Weight loss', 'protein levels', 'serum irisin, FGF21, visfatin, and FSTL1 levels', 'Irisin, FGF21, visfatin, and FSTL1 levels', 'physical activity', 'serum irisin, fibroblast growth', 'factor-21 (FGF21), visfatin, follistatin like protein-1 (FSTL1), and meteorin-like protein (Metrnl) levels', 'irisin, visfatin, and FSTL1 levels and fasting glucose and HbA1c levels', 'Serum protein levels, anthropometric measurements, and biochemical parameters', 'total change in weight', 'initial body weight']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012167', 'cui_str': 'Weight reduction diet'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0042291', 'cui_str': 'valproic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0068707', 'cui_str': 'Nicotinamide phosphoribosyltransferase'}, {'cui': 'C1136225', 'cui_str': 'Follistatin-Related Protein 1'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0016030', 'cui_str': 'Fibroblast'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0036825', 'cui_str': 'Serum protein'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]",60.0,0.0138425,"RESULTS Irisin, FGF21, visfatin, and FSTL1 levels significantly decreased in both groups after 12-week intervention (p < 0.001).","[{'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'Tok', 'Affiliation': 'Karadeniz Technical University, Faculty of Health Sciences, Department of Nutrition and Dietetics, Trabzon, Turkey. Electronic address: ozlemtok@ktu.edu.tr.'}, {'ForeName': 'Savaş Volkan', 'Initials': 'SV', 'LastName': 'Kişioğlu', 'Affiliation': 'Karadeniz Technical University, Faculty of Medicine, Division of Endocrinology and Metabolism, Trabzon, Turkey.'}, {'ForeName': 'Halil Önder', 'Initials': 'HÖ', 'LastName': 'Ersöz', 'Affiliation': 'Karadeniz Technical University, Faculty of Medicine, Division of Endocrinology and Metabolism, Trabzon, Turkey.'}, {'ForeName': 'Bahittin', 'Initials': 'B', 'LastName': 'Kahveci', 'Affiliation': 'Karadeniz Technical University, Faculty of Health Sciences, Department of Nutrition and Dietetics, Trabzon, Turkey.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Göktaş', 'Affiliation': 'Hacettepe University, Faculty of Health Sciences, Department of Nutrition and Dietetics, Ankara, Turkey. Electronic address: zeynep.goktas@hacettepe.edu.tr.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2021.107892'] 2418,33685036,The Behavioral Effects of Combination Therapy of Memantine and Acetylcholinesterase Inhibitors Compared with Acetylcholinesterase Inhibitors Alone in Patients with Moderate Alzheimer's Dementia: A Double-Blind Randomized Placebo-Controlled Trial.,"OBJECTIVE This study aimed to investigate treatment effects of combination therapy of memantine and acetylcholinesterase inhibitors (AchEIs) compared with AchEIs alone on behavioral and psychological symptoms of dementia (BPSD) in patients with moderate Alzheimer's dementia (AD). METHODS This was a 12-week, double-blind, randomized, placebo-controlled trial. A total of 148 patients with moderate AD participated in this study. Mini-Mental State Examination, Neuropsychiatric Inventory (NPI), Clinician's Interview-Based Impression of Change plus caregiver input, Gottfries-Bråne-Steen Scale, and Zarit Burden Interview were used as assessment scales. RESULTS There were no significant differences in age, sex, or education between AChEIs alone and combination groups. The combination group showed significantly more improvement of NPI-disinhibition score (0.76±2.15) than the AChEIs alone group (-0.14±1.71) after 12 weeks. CONCLUSION Our findings suggest that the combination therapy of memantine and AchEIs might be a beneficial option for reducing disinhibition symptoms of patients with moderate AD compared with AchEIs alone. We believe that clinicians need to consider additional memantine treatment when patients with moderate AD complain disinhibition symptom. A larger clinical trial is needed to further determine the efficacy and advantages of such combination therapy of memantine and AchEIs for treating BPSD of patients with moderate AD.",2021,"The combination group showed significantly more improvement of NPI-disinhibition score (0.76±2.15) than the AChEIs alone group (-0.14±1.71) after 12 weeks. ","[""patients with moderate Alzheimer's dementia (AD"", 'patients with moderate AD complain disinhibition symptom', '148 patients with moderate AD participated in this study', 'patients with moderate AD', ""Patients with Moderate Alzheimer's Dementia""]","['placebo', 'Memantine and Acetylcholinesterase Inhibitors', 'memantine and acetylcholinesterase inhibitors (AchEIs', 'Acetylcholinesterase Inhibitors Alone', 'Placebo', 'memantine']","[""Mini-Mental State Examination, Neuropsychiatric Inventory (NPI), Clinician's Interview-Based Impression of Change plus caregiver input, Gottfries-Bråne-Steen Scale, and Zarit Burden Interview"", 'disinhibition symptoms', 'NPI-disinhibition score', 'behavioral and psychological symptoms of dementia (BPSD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0234410', 'cui_str': 'Disinhibition'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0001046', 'cui_str': 'Acetylcholinesterase inhibitor'}]","[{'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0234410', 'cui_str': 'Disinhibition'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}]",148.0,0.430247,"The combination group showed significantly more improvement of NPI-disinhibition score (0.76±2.15) than the AChEIs alone group (-0.14±1.71) after 12 weeks. ","[{'ForeName': 'HyunChul', 'Initials': 'H', 'LastName': 'Youn', 'Affiliation': 'Department of Psychiatry, Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea.'}, {'ForeName': 'Kang Joon', 'Initials': 'KJ', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Ilsanpaik Hospital, Inje University College of Medicine, Goyang, Republic of Korea.'}, {'ForeName': 'Shin-Gyeom', 'Initials': 'SG', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea.'}, {'ForeName': 'Seong-Jin', 'Initials': 'SJ', 'LastName': 'Cho', 'Affiliation': 'Department of Psychiatry, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Woo Jung', 'Initials': 'WJ', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Yongin Severance Hospital, Yonsei University College of Medicine, Yongin, Republic of Korea.'}, {'ForeName': 'Won Joon', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jae Yeon', 'Initials': 'JY', 'LastName': 'Hwang', 'Affiliation': 'Department of Psychiatry, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Changsu', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'Department of Psychiatry, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Cheolmin', 'Initials': 'C', 'LastName': 'Shin', 'Affiliation': 'Department of Psychiatry, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Han-Yong', 'Initials': 'HY', 'LastName': 'Jung', 'Affiliation': 'Department of Psychiatry, Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea.'}]",Psychiatry investigation,['10.30773/pi.2020.0329'] 2419,33684508,"Adverse event recording failed to reflect potential harms: a review of trial protocols of behavioral, lifestyle and psychological therapy interventions.","OBJECTIVE To explore how potential harms are assessed in trials of behavioral, lifestyle and psychological therapy interventions. STUDY DESIGN AND SETTING This study was a review of protocols from the National Institute of Health Research Health Technology Assessment and Public Health Research programmes. Protocols were included if the study was a randomized controlled trial and the intervention intended to change lifestyle or behavior to improve health or improve psychological outcomes. RESULTS 95 of 151 protocols planned to record adverse events (AEs). Definitions of AEs were often not given and varied widely. Serious AEs were mostly defined using standards originally devised for pharmacological trials. Twenty-two protocols listed expected AEs. Few protocols described assessment of causation between AEs and intervention. Examples of useful AE recording practice were identified. CONCLUSION Monitoring and recording AEs in behavioral intervention trials was variable and frequently based on reporting guidelines for pharmacological trials. This may mean potential harms are being missed. Future trials should consider: 1) Potential harms posed by the intervention 2) How to define serious AEs 3) What are expected AEs. Further research to achieve consensus on AE recording is required, including identification of core adverse outcomes in clinical areas or caused by interventions.",2021,"RESULTS 95 of 151 protocols planned to record adverse events (AEs).",[],"['behavioural, lifestyle and psychological therapy interventions']",['adverse events (AEs'],[],"[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0841584', 'cui_str': 'Psychological therapies'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0474774,"RESULTS 95 of 151 protocols planned to record adverse events (AEs).","[{'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Papaioannou', 'Affiliation': 'Sheffield Clinical Trials Research Unit, School of Health and Related Research, University of Sheffield, Sheffield, United Kingdom. Electronic address: d.papaioannou@sheffield.ac.uk.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Sheffield Clinical Trials Research Unit, School of Health and Related Research, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Mooney', 'Affiliation': 'Sheffield Clinical Trials Research Unit, School of Health and Related Research, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Glover', 'Affiliation': 'Sheffield Clinical Trials Research Unit, School of Health and Related Research, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Coates', 'Affiliation': 'Sheffield Clinical Trials Research Unit, School of Health and Related Research, University of Sheffield, Sheffield, United Kingdom.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2021.03.002'] 2420,33687487,"Efficacy and safety of PEGylated exenatide injection (PB-119) in treatment-naive type 2 diabetes mellitus patients: a Phase II randomised, double-blind, parallel, placebo-controlled study.","AIMS/HYPOTHESIS Glucagon-like peptide 1 receptor agonists (GLP-1 RA) such as exenatide are used as monotherapy and add-on therapy for maintaining glycaemic control in patients with type 2 diabetes mellitus. The current study investigated the safety and efficacy of once-weekly PB-119, a PEGylated exenatide injection, in treatment-naive patients with type 2 diabetes. METHODS In this Phase II, randomised, placebo-controlled, double-blind study, we randomly assigned treatment-naive Chinese patients with type 2 diabetes in a 1:1:1:1 ratio to receive subcutaneous placebo or one of three subcutaneous doses of PB-119 (75, 150, and 200 μg) for 12 weeks. The primary endpoint was the change in HbA 1c from baseline to week 12, and other endpoints were fasting plasma glucose, 2 h postprandial glucose (PPG), and proportion of patients with HbA 1c  < 53 mmol/mol (<7.0%) and ≤48 mmol/mol (≤6.5%) at 2, 4, 8 and 12 weeks of treatment. Safety was assessed in all patients who received at least one dose of study drug. RESULTS We randomly assigned 251 patients to one of the four treatment groups (n = 62 in placebo and 63 each in PB-119 75 μg, 150 μg and 200 μg groups). At the end of 12 weeks, mean differences in HbA 1c in the treatment groups were -7.76 mmol/mol (95% CI -9.23, -4.63, p < 0.001) (-0.72%, 95% CI -1.01, -0.43), -12.89 mmol/mol (95% CI -16.05, -9.72, p < 0.001) (-1.18%, 95% CI -1.47, -0.89) and -11.14 mmol/mol (95% CI -14.19, -7.97, p <0 .001) (-1.02%, 95% CI -1.30, -0.73) in the 75 μg, 150 μg and 200 μg PB-119 groups, respectively, compared with that in the placebo group after adjusting for baseline HbA 1c . Similar results were also observed for other efficacy endpoints across different time points. There was no incidence of treatment-emergent serious adverse event, severe hypoglycaemia or death. CONCLUSIONS/INTERPRETATION All tested PB-119 doses had superior efficacy compared with placebo and were safe and well tolerated over 12 weeks in treatment-naive Chinese patients with type 2 diabetes. TRIAL REGISTRATION ClinicalTrials.gov NCT03520972 FUNDING: The study was funded by National Major Scientific and Technological Special Project for Significant New Drugs Development and PegBio.",2021,"All tested PB-119 doses had superior efficacy compared with placebo and were safe and well tolerated over 12 weeks in treatment-naive Chinese patients with type 2 diabetes. ","['naive Chinese patients with type 2 diabetes in a 1:1:1:1 ratio to receive', 'patients with type 2 diabetes mellitus', 'treatment-naive type 2 diabetes mellitus patients', 'naive Chinese patients with type 2 diabetes', 'treatment-naive patients with type 2 diabetes']","['PEGylated exenatide injection', 'placebo', 'mmol/mol ', 'PB-119', 'PEGylated exenatide injection (PB-119', 'subcutaneous placebo']","['change in HbA 1c', 'safe and well tolerated', 'safety and efficacy', 'Efficacy and safety', 'fasting plasma glucose, 2\xa0h postprandial glucose (PPG), and proportion of patients with HbA 1c', 'Safety', 'incidence of treatment-emergent serious adverse event, severe hypoglycaemia or death']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C4026821', 'cui_str': 'exenatide Injection'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",251.0,0.611628,"All tested PB-119 doses had superior efficacy compared with placebo and were safe and well tolerated over 12 weeks in treatment-naive Chinese patients with type 2 diabetes. ","[{'ForeName': 'Linong', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': ""Department of Endocrinology, Peking University People's Hospital, Beijing, China. jiln@bjmu.edu.cn.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'PegBio Co., Ltd, Suzhou, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'PegBio Co., Ltd, Suzhou, China.'}, {'ForeName': 'Xiangjun', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'PegBio Co., Ltd, Suzhou, China.'}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Mo', 'Affiliation': 'Department of Endocrinology, The Third Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing, China.'}, {'ForeName': 'Jiarui', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'The Third Endocrinology Department, Cangzhou Central Hospital, Cangzhou, China.'}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, Beijing Pinggu Hospital, Beijing, China.'}, {'ForeName': 'Jingna', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': ""Department of Endocrinology, Tianjin People's Hospital, Tianjin, China.""}, {'ForeName': 'Yanjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology, The Second Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Endocrinology, First Hospital of Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Weihong', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': ""Department of Endocrinology and Diabetes, Chenzhou No 1 People's Hospital, Chenzhou, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': 'Department of Endocrinology, Zhongda Hospital Southeast University, Nanjing, China.'}, {'ForeName': 'Shuguang', 'Initials': 'S', 'LastName': 'Pang', 'Affiliation': 'Department of Endocrinology, Jinan Central Hospital, Jinan, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Endocrinology, Luoyang Central Hospital, Luoyang, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, Yuncheng Central Hospital, Yuncheng, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Henan University of Science and Technology, Henan, China.'}, {'ForeName': 'Minxiu', 'Initials': 'M', 'LastName': 'Yao', 'Affiliation': 'Department of Endocrinology, Qingdao Central Hospital, Qingdao, China.'}, {'ForeName': 'Wenhui', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, Beijing Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': ""Department of Endocrinology, The First People's Hospital of Changzhou, Changzhou, China.""}, {'ForeName': 'Feixia', 'Initials': 'F', 'LastName': 'Shen', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Houfa', 'Initials': 'H', 'LastName': 'Geng', 'Affiliation': 'Department of Endocrinology, Xuzhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': ""Department of Endocrinology, The First People's Hospital, Changde, China.""}, {'ForeName': 'Jianmin', 'Initials': 'J', 'LastName': 'Ran', 'Affiliation': 'Department of Endocrinology, Guangzhou Red Cross Hospital, Guangzhou, China.'}, {'ForeName': 'Minxiang', 'Initials': 'M', 'LastName': 'Lei', 'Affiliation': 'Department of Endocrinology, Xiangya Hospital Central South University, Changsha, China.'}, {'ForeName': 'Yinghong', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Department of Endocrinology, Guangzhou Panyu Central Hospital, Guangzhou, China.'}, {'ForeName': 'Shandong', 'Initials': 'S', 'LastName': 'Ye', 'Affiliation': 'Department of Endocrinology, Anhui Provincial Hospital, Hefei, China.'}, {'ForeName': 'Qingbo', 'Initials': 'Q', 'LastName': 'Guan', 'Affiliation': 'Department of Endocrinology, Shandong Provincial Hospital, Jinan, China.'}, {'ForeName': 'Wenshan', 'Initials': 'W', 'LastName': 'Lv', 'Affiliation': 'Department of Endocrinology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Huiwen', 'Initials': 'H', 'LastName': 'Tan', 'Affiliation': 'Department of Endocrinology, West China Hospital Sichuan University, Sichuan, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Department of Endocrinology, West China Hospital Sichuan University, Sichuan, China.'}, {'ForeName': 'Jinkui', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Endocrinology, Beijing Tongren Hospital, CMU, Beijing, China.'}, {'ForeName': 'Guijun', 'Initials': 'G', 'LastName': 'Qin', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Zhengzhou University, Henan, China.'}, {'ForeName': 'Shiyun', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, Affiliated Hospital & Clinical Medical College of Chengdu University, Chengdu, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Endocrinology, Suzhou Municipal Hospital, Suzhou, China.'}]",Diabetologia,['10.1007/s00125-021-05392-9'] 2421,33694093,Efficacy and Safety of Ertugliflozin in Patients With Diabetes Mellitus Inadequately Controlled by Sulfonylurea Monotherapy: a Substudy of VERTIS CV.,"INTRODUCTION Sulfonylureas (SU) are commonly used antihyperglycemic agents. VERTIS CV was the cardiovascular outcome study for the sodium-glucose cotransporter 2 inhibitor ertugliflozin. Enrollment of patients in VERTIS CV occurred in two sequential cohorts (Cohort 1 and Cohort 2). METHODS This substudy assessed the efficacy and safety of adding ertugliflozin to SU monotherapy. The primary endpoint was the change in HbA1c from baseline at 18 weeks. RESULTS Among the 8246 patients who were randomized in VERTIS CV, 157 patients in Cohort 1 and 135 patients in Cohort 2 were on SU monotherapy at baseline. In the prespecified analysis (Cohort 1 only), the least squares (LS) mean HbA1c change from baseline for placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg was -  0.56%, -  0.91%, and -  0.78%, respectively (placebo-adjusted LS mean [95% CI] change: - 0.35% [-  0.72%, 0.02%]; -  0.22% [-  0.60%, 0.16%] for ertugliflozin 5 and 15 mg, respectively; p > 0.05 for both). In a post-hoc analysis that included Cohorts 1 and 2 (N = 292), the LS mean HbA1c change from baseline at week 18 for placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg was -  0.31%, - 0.77%, and -  0.68%, respectively (placebo-adjusted change: -  0.46% [-  0.73%, -  0.18%]; -  0.37% [-  0.66%, -  0.09%]; p = 0.001 and 0.01 for ertugliflozin 5 and 15 mg, respectively). In Cohort 1, adverse events were reported in 45.8%, 47.3%, and 25.9% of patients with placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg. The incidence rates of symptomatic hypoglycemia were 0.0%, 5.5%, and 3.7%, respectively, with no cases of severe hypoglycemia. The safety profile was similar for Cohorts 1 and 2 combined. CONCLUSION The addition of ertugliflozin to SU monotherapy reduced HbA1c but did not result in significant placebo-adjusted reductions from baseline according to the prespecified primary analysis (n = 157); however, in a post-hoc analysis with a larger patient population (n = 292), significant and clinically relevant HbA1c reductions were observed. Ertugliflozin was generally well tolerated. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT01986881.",2021,"The addition of ertugliflozin to SU monotherapy reduced HbA1c but did not result in significant placebo-adjusted reductions from baseline according to the prespecified primary analysis (n = 157); however, in a post-hoc analysis with a larger patient population (n = 292), significant and clinically relevant HbA1c reductions were observed.","['Patients With Diabetes', '8246 patients who were randomized in VERTIS CV, 157 patients in Cohort 1 and 135 patients in Cohort 2 were on SU monotherapy at baseline']","['ertugliflozin', 'ertugliflozin to SU monotherapy', 'Sulfonylurea Monotherapy', 'Sulfonylureas (SU', 'placebo, ertugliflozin', 'Ertugliflozin']","['incidence rates of symptomatic hypoglycemia', 'tolerated', 'safety profile', 'Efficacy and Safety', 'LS mean HbA1c change', 'efficacy and safety', 'change in HbA1c', 'adverse events', 'severe hypoglycemia', 'least squares (LS) mean HbA1c change']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}]",8246.0,0.326994,"The addition of ertugliflozin to SU monotherapy reduced HbA1c but did not result in significant placebo-adjusted reductions from baseline according to the prespecified primary analysis (n = 157); however, in a post-hoc analysis with a larger patient population (n = 292), significant and clinically relevant HbA1c reductions were observed.","[{'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Strojek', 'Affiliation': 'Department of Internal Diseases, Diabetology and Cardiometabolic Diseases, Faculty of Medical Sciences Zabrze, Medical University of Silesia, Katowice, Poland. KSTROJEK@sum.edu.pl.'}, {'ForeName': 'A Shekhar', 'Initials': 'AS', 'LastName': 'Pandey', 'Affiliation': 'Cambridge Cardiac Care Centre, Cambridge, ON, Canada.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Dell', 'Affiliation': 'Pfizer Inc., New York, NY, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Sisson', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Huyck', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Gantz', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-021-01018-w'] 2422,33689731,Comparison of Outcomes with Midodrine and Fludrocortisone for Objective Recurrence in Treating Syncope (COMFORTS trial): Rationale and design for a multi-center randomized controlled trial.,"BACKGROUND The cornerstone of the treatment of vasovagal syncope (VVS) is lifestyle modifications; however, some patients incur life-disturbing attacks despite compliance with these treatments which underscores the importance of pharmacological interventions. METHODS In this open-label multi-center randomized controlled trial, we are going to randomize 1375 patients with VVS who had ≥2 syncopal episodes in the last year into three parallel arms with a 2:2:1 ratio to receive midodrine, fludrocortisone, or no medication. All patients will be recommended to drink 2 to 3 liters of fluids per day, consume 10 grams of NaCl per day, and practice counter-pressure maneuvers. In medication arms, patients will start on 5 mg of midodrine TDS or 0.05 mg of fludrocortisone BD. After one week the dosage will be up-titrated to midodrine 30 mg/day and fludrocortisone 0.2 mg/day. Patient tolerance will be the principal guide to dosage adjustments. We will follow-up the patients on 3, 6, 9, and 12 months after randomization. The primary outcome is the time to first syncopal episode. Secondary outcomes include the recurrence rate of VVS, time interval between first and second episodes, changes in quality of life (QoL), and major and minor adverse drug reactions. QoL will be examined by the 36-Item Short Form Survey questionnaire at enrollment and 12 months after randomization. CONCLUSION The COMFORTS trial is the first study that aims to make a head-to-head comparison between midodrine and fludrocortisone, against a background of lifestyle modifications for preventing recurrences of VVS and improving QoL in patients with VVS.",2021,"Secondary outcomes include the recurrence rate of VVS, time interval between first and second episodes, changes in quality of life (QoL), and major and minor adverse drug reactions.","['1375 patients with VVS who had ≥2 syncopal episodes in the last year into three parallel arms with a 2:2:1 ratio to receive', 'Treating Syncope (COMFORTS trial', 'patients with VVS']","['Midodrine and Fludrocortisone', 'midodrine 30 mg/day and fludrocortisone 0.2 mg/day', 'midodrine, fludrocortisone, or no medication', 'fludrocortisone BD', 'midodrine TDS']","['recurrence rate of VVS, time interval between first and second episodes, changes in quality of life (QoL), and major and minor adverse drug reactions', 'time to first syncopal episode']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1836438', 'cui_str': 'Familial neurocardiogenic syncope'}, {'cui': 'C0751534', 'cui_str': 'Syncopal Episode'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0039070', 'cui_str': 'Syncope'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0026078', 'cui_str': 'Midodrine'}, {'cui': 'C0016280', 'cui_str': 'Fludrocortisone'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0172161', 'cui_str': 'tyramine-deoxysorbitol'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C1836438', 'cui_str': 'Familial neurocardiogenic syncope'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0751534', 'cui_str': 'Syncopal Episode'}]",1375.0,0.162459,"Secondary outcomes include the recurrence rate of VVS, time interval between first and second episodes, changes in quality of life (QoL), and major and minor adverse drug reactions.","[{'ForeName': 'Arya', 'Initials': 'A', 'LastName': 'Aminorroaya', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran; Non-Communicable Disease Research Center, Endocrinology and Metabolism Population Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Tavolinejad', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Sadeghian', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Jalali', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farshid', 'Initials': 'F', 'LastName': 'Alaeddini', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Emkanjoo', 'Affiliation': 'Cardiac Electrophysiology Research Center, Rajaie Cardiovascular, Medical & Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Mollazadeh', 'Affiliation': 'Department of Cardiology, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Bozorgi', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Oraii', 'Affiliation': 'Tehran Arrhythmia Center, Tehran, Iran.'}, {'ForeName': 'Mohamadreza', 'Initials': 'M', 'LastName': 'Kiarsi', 'Affiliation': 'Department of Cardiology, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Shahabi', 'Affiliation': 'Cardiac Rehabilitation Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Akbarzadeh', 'Affiliation': 'Cardiovascular Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Rahimi', 'Affiliation': 'Department of Cardiology, School of Medicine, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Joharimoghadam', 'Affiliation': 'Department of Cardiology, AJA University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Abolfazl', 'Initials': 'A', 'LastName': 'Mohsenizade', 'Affiliation': 'Department of Cardiology, AJA University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Roghayeh', 'Initials': 'R', 'LastName': 'Mohammadi', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Oraii', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Ariannejad', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sanatcha', 'Initials': 'S', 'LastName': 'Apakuppakul', 'Affiliation': 'Cardiac Arrhythmia Service, Cardiovascular Disease Section, Department of Internal Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Tachapong', 'Initials': 'T', 'LastName': 'Ngarmukos', 'Affiliation': 'Cardiac Arrhythmia Service, Cardiovascular Disease Section, Department of Internal Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand. Electronic address: tachapong.nga@mahidol.ac.th.'}, {'ForeName': 'Masih', 'Initials': 'M', 'LastName': 'Tajdini', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: mtajdini@sina.tums.ac.ir.'}]",American heart journal,['10.1016/j.ahj.2021.03.002'] 2423,33689730,Randomized comparison of early supplemental oxygen versus ambient air in patients with confirmed myocardial infarction: Sex-related outcomes from DETO2X-AMI.,"BACKGROUND The purpose of this study is to investigate the impact of oxygen therapy on cardiovascular outcomes in relation to sex in patients with confirmed myocardial infarction (MI). METHODS The DETermination of the role of Oxygen in suspected Acute Myocardial Infarction trial randomized 6,629 patients to oxygen at 6 L/min for 6-12 hours or ambient air. In the present subgroup analysis including 5,010 patients (1,388 women and 3,622 men) with confirmed MI, we report the effect of supplemental oxygen on the composite of all-cause death, rehospitalization with MI, or heart failure at long-term follow-up, stratified according to sex. RESULTS Event rate for the composite endpoint was 18.1% in women allocated to oxygen, compared to 21.4% in women allocated to ambient air (hazard ratio [HR] 0.83, 95% confidence interval [CI] 0.65-1.05). In men, the incidence was 13.6% in patients allocated to oxygen compared to 13.3% in patients allocated to ambient air (HR 1.03, 95% CI 0.86-1.23). No significant interaction in relation to sex was found (P= .16). Irrespective of allocated treatment, the composite endpoint occurred more often in women compared to men (19.7 vs 13.4%, HR 1.51; 95% CI, 1.30-1.75). After adjustment for age alone, there was no difference between the sexes (HR 1.06, 95% CI 0.91-1.24), which remained consistent after multivariate adjustment. CONCLUSION Oxygen therapy in normoxemic MI patients did not significantly affect all-cause mortality or rehospitalization for MI or heart failure in women or men. The observed worse outcome in women was explained by differences in baseline characteristics, especially age.",2021,"CONCLUSION Oxygen therapy in normoxemic MI patients did not significantly affect all-cause mortality or rehospitalization for MI or HF in women or men.","['on the composite of all-cause death, rehospitalization with MI, or heart failure (HF) at long-term follow-up, stratified according to sex', 'normoxemic MI patients', '5,010 patients (1,388 women and 3,622 men) with confirmed MI', 'patients with confirmed myocardial infarction (MI', 'patients with confirmed myocardial infarction', '6,629 patients to oxygen at 6 L/min for 6-12 hours or ambient air']","['early supplemental oxygen versus ambient air', 'oxygen therapy', 'Oxygen therapy', 'supplemental oxygen']",['cardiovascular outcomes'],"[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0001861', 'cui_str': 'Air'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",6629.0,0.205182,"CONCLUSION Oxygen therapy in normoxemic MI patients did not significantly affect all-cause mortality or rehospitalization for MI or HF in women or men.","[{'ForeName': 'Joakim', 'Initials': 'J', 'LastName': 'Alfredsson', 'Affiliation': 'Department of Health, Medicine and Caring Sciences and Department of Cardiology, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Stefan K', 'Initials': 'SK', 'LastName': 'James', 'Affiliation': 'Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden; Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Erlinge', 'Affiliation': 'Department of Clinical Sciences, Cardiology, Lund University, Lund, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Herlitz', 'Affiliation': 'Department of Health Sciences, University of Borås, Borås, Sweden.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Fröbert', 'Affiliation': 'Department of Cardiology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Dworeck', 'Affiliation': 'Department of Molecular and Clinical Medicine and Sahlgrenska University Hospital, Department of Cardiology, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Redfors', 'Affiliation': 'Department of Molecular and Clinical Medicine and Sahlgrenska University Hospital, Department of Cardiology, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Arefalk', 'Affiliation': 'Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Ollie', 'Initials': 'O', 'LastName': 'Östlund', 'Affiliation': 'Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Jernberg', 'Affiliation': 'Department of Clinical Sciences, Cardiology, Karolinska Institutet, Danderyd Hospital, Stockholm, Sweden.'}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Mars', 'Affiliation': 'Department of Clinical Science and Education, Division of Cardiology, Karolinska Institutet-Södersjukhuset, Stockholm, Sweden.'}, {'ForeName': 'Urban', 'Initials': 'U', 'LastName': 'Haaga', 'Affiliation': 'Department of Cardiology, Karlstad Central Hospital, Karlstad, Sweden.'}, {'ForeName': 'Bertil', 'Initials': 'B', 'LastName': 'Lindahl', 'Affiliation': 'Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden; Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Swahn', 'Affiliation': 'Department of Health, Medicine and Caring Sciences and Department of Cardiology, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Sofia Sederholm', 'Initials': 'SS', 'LastName': 'Lawesson', 'Affiliation': 'Department of Health, Medicine and Caring Sciences and Department of Cardiology, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Hofmann', 'Affiliation': 'Department of Clinical Science and Education, Division of Cardiology, Karolinska Institutet-Södersjukhuset, Stockholm, Sweden. Electronic address: robin.hofmann@sll.se.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2021.03.001'] 2424,33711390,THAP11 down-regulation may contribute to cardio-protective effects of sevoflurane anesthesia: Evidence from clinical and molecular evidence.,"This study aimed to explore the potential target of the cardio-protective effect induced by sevoflurane anesthesia based on evidence from clinical samples and in vitro model. Forty patients undergoing mitral valve replacement were randomly allocated to receive sevoflurane or propofol-based anesthesia. Atrial muscle specimens were collected from all patients, of which 5 were used to perform transcriptomics analysis. The cTn-I concentration was tested before, at the end of, and 24 h after surgery. In in vitro study, the expression level of the identified target gene, i.e., THAP11, was studied in H9C2 cells treated with sevoflurane or propofol. Then, we studied cell viability using CCK-8 staining, apoptosis by using flow cytometry, and cell death by lactic acid dehydrogenase (LDH) detection in H9C2 cells exposed to oxygen glucose deprivation/reoxygenation (OGD/R) injury. THAP11 was the most significantly down-regulated gene in the transcriptomics analysis (P < 0.001), as confirmed in validation samples (P = 0.006). THAP11 mRNA levels in atrial muscle specimens were positively associated with cTn-I levels at 24-h postoperatively (determination coefficient = 0.564; P < 0.001). Sevoflurane treatment down-regulated THAP11 in H9C2 cell models, which promoted cell viability, inhibited cell apoptosis, and death in the OGD/R injury cell model. Up-regulation of THAP11 reduced the protective effect of sevoflurane treatment against OGD/R injury. Sevoflurane anesthesia down-regulates the expression of THAP11, which contributes to a cardio-protective effect. THAP11 down-regulation promotes cell viability, and inhibits cell apoptosis and death, thereby protecting again myocardial injury; it may therefore be a novel target for perioperative cardio-protection.",2021,"THAP11 was the most significantly down-regulated gene in the transcriptomics analysis (P < 0.001), as confirmed in validation samples (P = 0.006).",['Forty patients undergoing mitral valve replacement'],"['sevoflurane', 'sevoflurane or propofol', 'Sevoflurane anesthesia', 'sevoflurane or propofol-based anesthesia', 'sevoflurane anesthesia', 'Sevoflurane', 'THAP11']","['THAP11 mRNA levels', 'THAP11', 'cell viability, inhibited cell apoptosis, and death', 'cell viability using CCK-8 staining, apoptosis by using flow cytometry, and cell death by lactic acid dehydrogenase (LDH) detection in H9C2 cells exposed to oxygen glucose deprivation/reoxygenation (OGD/R) injury']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026268', 'cui_str': 'Replacement of mitral valve'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007620', 'cui_str': 'Cell Viability'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0037167', 'cui_str': 'Sincalide'}, {'cui': 'C0487602', 'cui_str': 'Staining method'}, {'cui': 'C0016263', 'cui_str': 'Flow cytometry'}, {'cui': 'C0007587', 'cui_str': 'Cell death'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]",40.0,0.110554,"THAP11 was the most significantly down-regulated gene in the transcriptomics analysis (P < 0.001), as confirmed in validation samples (P = 0.006).","[{'ForeName': 'Zhenxin', 'Initials': 'Z', 'LastName': 'Duan', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Huifang', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Guangyou', 'Initials': 'G', 'LastName': 'Duan', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Army Medical University, Chongqing, China. Electronic address: dgy1986anesthesia@126.com.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Army Medical University, Chongqing, China. Electronic address: lh78553@163.com.'}]",Life sciences,['10.1016/j.lfs.2021.119327'] 2425,33676601,"Pembrolizumab versus investigator-choice chemotherapy for metastatic triple-negative breast cancer (KEYNOTE-119): a randomised, open-label, phase 3 trial.","BACKGROUND Pembrolizumab showed durable antitumour activity and manageable safety in metastatic triple-negative breast cancer in the single-arm KEYNOTE-012 and KEYNOTE-086 trials. In this study, we compared pembrolizumab with chemotherapy for second-line or third-line treatment of patients with metastatic triple-negative breast cancer. METHODS KEYNOTE-119 was a randomised, open-label, phase 3 trial done at 150 medical centres (academic medical centres, community cancer centres, and community hospitals) in 31 countries. Patients aged 18 years or older, with centrally confirmed metastatic triple-negative breast cancer, Eastern Cooperative Oncology Group performance status of 0 or 1, who had received one or two previous systemic treatments for metastatic disease, had progression on their most recent therapy, and had previous treatment with an anthracycline or taxane were eligible. Patients were randomly assigned (1:1) using a block method (block size of four) and an interactive voice-response system with integrated web-response to receive intravenous pembrolizumab 200 mg once every 3 weeks for 35 cycles (pembrolizumab group), or to single-drug chemotherapy per investigator's choice of capecitabine, eribulin, gemcitabine, or vinorelbine (60% enrolment cap for each; chemotherapy group). Randomisation was stratified by PD-L1 tumour status (positive [combined positive score (CPS) ≥1] vs negative [CPS <1]) and history of previous neoadjuvant or adjuvant treatment versus de-novo metastatic disease at initial diagnosis. Primary endpoints were overall survival in participants with a PD-L1 combined positive score (CPS) of 10 or more, those with a CPS of 1 or more, and all participants; superiority of pembrolizumab versus chemotherapy was tested in all participants only if shown in those with a CPS of one or more. The primary endpoint was analysed in the intention-to-treat population; safety was analysed in the all-subjects-as-treated population. This Article describes the final analysis of the trial, which is now completed. This trial is registered with ClinicalTrials.gov, number NCT02555657. FINDINGS From Nov 25, 2015, to April 11, 2017, 1098 participants were assessed for eligibility and 622 (57%) were randomly assigned to receive either pembrolizumab (312 [50%]) or chemotherapy (310 [50%]). Median study follow-up was 31·4 months (IQR 27·8-34·4) for the pembrolizumab group and 31·5 months (27·8-34·6) for the chemotherapy group. Median overall survival in patients with a PD-L1 CPS of 10 or more was 12·7 months (95% CI 9·9-16·3) for the pembrolizumab group and 11·6 months (8·3-13·7) for the chemotherapy group (hazard ratio [HR] 0·78 [95% CI 0·57-1·06]; log-rank p=0·057). In participants with a CPS of 1 or more, median overall survival was 10·7 months (9·3-12·5) for the pembrolizumab group and 10·2 months (7·9-12·6) for the chemotherapy group (HR 0·86 [95% CI 0·69-1·06]; log-rank p=0·073). In the overall population, median overall survival was 9·9 months (95% CI 8·3-11·4) for the pembrolizumab group and 10·8 months (9·1-12·6) for the chemotherapy group (HR 0·97 [95% CI 0·82-1·15]). The most common grade 3-4 treatment-related adverse events were anaemia (three [1%] patients in the pembrolizumab group vs ten [3%] in the chemotherapy group), decreased white blood cells (one [<1%] vs 14 [5%]), decreased neutrophil count (one [<1%] vs 29 [10%]), and neutropenia (0 vs 39 [13%]). 61 (20%) patients in the pembrolizumab group and 58 (20%) patients in the chemotherapy group had serious adverse events. Three (<1%) of 601 participants had treatment-related adverse events that led to death (one [<1%] in the pembrolizumab group due to circulatory collapse; two [1%] in the chemotherapy group, one [<1%] due to pancytopenia and sepsis and one [<1%] haemothorax). INTERPRETATION Pembrolizumab did not significantly improve overall survival in patients with previously treated metastatic triple-negative breast cancer versus chemotherapy. These findings might inform future research of pembrolizumab monotherapy for selected subpopulations of patients, specifically those with PD-L1-enriched tumours, and inform a combinatorial approach for the treatment of patients with metastatic triple-negative breast cancer. FUNDING Merck Sharp & Dohme.",2021,"INTERPRETATION Pembrolizumab did not significantly improve overall survival in patients with previously treated metastatic triple-negative breast cancer versus chemotherapy.","['metastatic triple-negative breast cancer (KEYNOTE-119', 'HR 0·97', '150 medical centres (academic medical centres, community cancer centres, and community hospitals) in 31 countries', 'Patients aged 18 years or older, with centrally confirmed metastatic triple-negative breast cancer, Eastern Cooperative Oncology Group performance status of 0 or 1, who had received one or two previous systemic treatments for metastatic disease, had progression on their most recent therapy, and had previous treatment with an', 'From Nov 25, 2015, to April 11, 2017, 1098 participants were assessed for eligibility and 622 (57', 'patients with metastatic triple-negative breast cancer', 'patients with previously treated metastatic triple-negative breast cancer versus']","['anthracycline or taxane', 'pembrolizumab monotherapy', 'Pembrolizumab versus investigator-choice chemotherapy', 'pembrolizumab with chemotherapy', 'pembrolizumab', 'chemotherapy', 'pembrolizumab versus chemotherapy', ""block method (block size of four) and an interactive voice-response system with integrated web-response to receive intravenous pembrolizumab 200 mg once every 3 weeks for 35 cycles (pembrolizumab group), or to single-drug chemotherapy per investigator's choice of capecitabine, eribulin, gemcitabine, or vinorelbine""]","['PD-L1 combined positive score (CPS', 'serious adverse events', 'Median overall survival', 'circulatory collapse', 'white blood cells', 'durable antitumour activity and manageable safety', 'median overall survival', 'neutrophil count', 'intention-to-treat population; safety', 'neutropenia', 'death', 'overall survival']","[{'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C2350866', 'cui_str': 'eribulin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}]","[{'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",1098.0,0.382782,"INTERPRETATION Pembrolizumab did not significantly improve overall survival in patients with previously treated metastatic triple-negative breast cancer versus chemotherapy.","[{'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Winer', 'Affiliation': 'Division of Breast Oncology, Dana-Farber Cancer Institute, Boston, MA, USA. Electronic address: eric_winer@dfci.harvard.edu.'}, {'ForeName': 'Oleg', 'Initials': 'O', 'LastName': 'Lipatov', 'Affiliation': 'Medical Oncology, Republican Clinical Oncology Dispensary, Ufa, Republic of Bashkortostan, Russia.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Internal Medicine, Seoul National University, Seoul, South Korea.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Goncalves', 'Affiliation': 'Department of Medical Oncology, Institut Paoli-Calmettes, Centre de Recherche en Cancérologie de Marseille, Aix-Marseille University, Centre National de la Recherche Scientifique, French National Institute of Health and Medical Research, Marseille, France.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Muñoz-Couselo', 'Affiliation': ""International Breast Cancer Center, Quiron Group, Madrid and Barcelona, Spain; Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Keun Seok', 'Initials': 'KS', 'LastName': 'Lee', 'Affiliation': 'Center for Breast Cancer, National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schmid', 'Affiliation': 'Centre for Experimental Cancer Medicine, Barts Cancer Institute, Queen Mary University London, London, UK.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': 'Department of Breast and Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Testa', 'Affiliation': 'Breast Medical Oncology, Instituto do Câncer do Estado de São Paulo, Faculdade de Medicina da Universidade do Estado do São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Isabell', 'Initials': 'I', 'LastName': 'Witzel', 'Affiliation': 'Department of Gynaecology, University Medical Center Hamburg, Hamburg, Germany.'}, {'ForeName': 'Shoichiro', 'Initials': 'S', 'LastName': 'Ohtani', 'Affiliation': 'Surgical Oncology, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Turner', 'Affiliation': 'Breast Unit, Royal Marsden National Health Service Foundation Trust, London, UK.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Zambelli', 'Affiliation': 'Medical Oncology, Istituto di Ricovero e Cura a Carattere Scientifico Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Harbeck', 'Affiliation': 'Breast Center, Ludwig-Maximilians-University, University Hospital, Munich, Germany.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Andre', 'Affiliation': 'Faculté de Medicine Paris-Sud XI, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Dent', 'Affiliation': 'Division of Medical Oncology, National Cancer Centre Singapore, Singapore.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Division of Medical Oncology, Merck, Kenilworth, NJ, USA.'}, {'ForeName': 'Vassiliki', 'Initials': 'V', 'LastName': 'Karantza', 'Affiliation': 'Division of Medical Oncology, Merck, Kenilworth, NJ, USA.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Mejia', 'Affiliation': 'Division of Medical Oncology, Merck, Kenilworth, NJ, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cortes', 'Affiliation': ""International Breast Cancer Center, Quiron Group, Madrid and Barcelona, Spain; Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30754-3'] 2426,33682223,Platelet-rich plasma with low dose oral minoxidil (1.25mg versus 2.5mg) along with trichoscopic pre- and post-treatment evaluation.,"BACKGROUND Low dose (<5 mg) oral minoxidil (OM) seems a promising option for male androgenetic alopecia (MAGA). AIM To evaluate the role of oral minoxidil 1.25 mg versus oral minoxidil 2.5 mg along with platelet-rich plasma in MAGA. METHODS Group A consisted of forty-seven patients which included patients on OM 1.25 mg daily and platelet-rich plasma therapy, and Group B consisted of 48 patients on OM 2.5 mg daily and platelet-rich plasma therapy. Photographs were taken before and after treatment along with trichoscopic evaluation. Selection of the dermoscopic variables was based on the published literature. RESULTS At 24 weeks, marked improvement on Global clinical photography (GCP) were seen in 19/47 (40.4%) in Group A and 28/48 (58.3%) patients in Group B with p value of 0.058. The total increase in total hair/cm 2 was around 24 and 36 in group A and B, respectively, with p > 0.05. The percentage increase in mean total hair count/cm 2 after 6 month of treatment was 15.41% in group A and 22.15% in group B, but they were not statistically significant. The patient satisfaction score on a Likert scale between both group were statistically significant,with Group B patients having a better satisfaction score. CONCLUSION This is a pilot study where OM along with PRP at different dosage (1.25mg vs 2.5mg) has been compared, low dose OM with PRP can be used in patients who are apprehensive of taking finasteride or dutasteride and are less responsive to topical minoxidil alone.",2021,"The percentage increase in mean total hair count/cm 2 after 6 month of treatment was 15.41% in group A and 22.15% in group B, but they were not statistically significant.","['patients who are a bit apprehensive on taking', ' Group A consisted of fourty seven patients which included patients on', 'male androgenetic alopecia (MAGA']","['OM 1.25mg daily and Platelet rich plasma therapy and Group B consisted of patients on OM 2.5 mg daily and Platelet rich plasma therapy', 'finasteride or dutasteride', 'minoxidil', 'minoxidil (OM', 'Platelet-rich plasma with low dose oral minoxidil']","['mean total hair count/cm 2', 'patient satisfaction score on a likert scale', 'GCP', 'total increase in total hair/cm2']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0045724', 'cui_str': '2-(4-ethoxybenzyl)-1-diethylaminoethyl-5-isothiocyanatobenzimidazole'}, {'cui': 'C0233485', 'cui_str': 'Apprehension'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0026196', 'cui_str': 'Minoxidil'}, {'cui': 'C4517497', 'cui_str': '1.25'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4727879', 'cui_str': 'Platelet rich plasma therapy'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0992616', 'cui_str': 'Minoxidil 2.5 MG'}, {'cui': 'C0060389', 'cui_str': 'Finasteride'}, {'cui': 'C0754659', 'cui_str': 'Dutasteride'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C1175868', 'cui_str': 'GCP (supplement)'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439479', 'cui_str': 'sq. cm'}]",,0.0191441,"The percentage increase in mean total hair count/cm 2 after 6 month of treatment was 15.41% in group A and 22.15% in group B, but they were not statistically significant.","[{'ForeName': 'Abhijeet Kumar', 'Initials': 'AK', 'LastName': 'Jha', 'Affiliation': 'Department of Skin& VD, Patna Medical College & Hospital, Patna, India.'}, {'ForeName': 'Md', 'Initials': 'M', 'LastName': 'Zeeshan', 'Affiliation': 'Department of Skin& VD, Patna Medical College & Hospital, Patna, India.'}, {'ForeName': 'Anupama', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Department of Skin& VD, Patna Medical College & Hospital, Patna, India.'}, {'ForeName': 'Prasoon Kumar', 'Initials': 'PK', 'LastName': 'Roy', 'Affiliation': 'Department of Skin& VD, Nalanda Medical College & Hospital, Patna, India.'}]",Journal of cosmetic dermatology,['10.1111/jocd.14049'] 2427,33686482,Early sedation with dexmedetomidine in ventilated critically ill patients and heterogeneity of treatment effect in the SPICE III randomised controlled trial.,"PURPOSE To quantify potential heterogeneity of treatment effect (HTE), of early sedation with dexmedetomidine (DEX) compared with usual care, and identify patients who have a high probability of lower or higher 90-day mortality according to age, and other identified clusters. METHODS Bayesian analysis of 3904 critically ill adult patients expected to receive invasive ventilation > 24 h and enrolled in a multinational randomized controlled trial comparing early DEX with usual care sedation. RESULTS HTE was assessed according to age and clusters (based on 12 baseline characteristics) using a Bayesian hierarchical models. DEX was associated with lower 90-day mortality compared to usual care in patients > 65 years (odds ratio [OR], 0.83 [95% credible interval [CrI] 0.68-1.00], with 97.7% probability of reduced mortality across broad categories of illness severity. Conversely, the probability of increased mortality in patients ≤ 65 years was 98.5% (OR 1.26 [95% CrI 1.02-1.56]. Two clusters were identified: cluster 1 (976 patients) mostly operative, and cluster 2 (2346 patients), predominantly non-operative. There was a greater probability of benefit with DEX in cluster 1 (OR 0.86 [95% CrI 0.65-1.14]) across broad categories of age, with 86.4% probability that DEX is more beneficial in cluster 1 than cluster 2. CONCLUSION In critically ill mechanically ventilated patients, early sedation with dexmedetomidine exhibited a high probability of reduced 90-day mortality in older patients regardless of operative or non-operative cluster status. Conversely, a high probability of increased 90-day mortality was observed in younger patients of non-operative status. Further studies are needed to confirm these findings.",2021,DEX was associated with lower 90-day mortality compared to usual care in patients > ,"['Two clusters were identified: cluster 1 (976 patients) mostly operative, and cluster 2 (2346 patients), predominantly non-operative', 'ventilated critically ill patients', 'patients who have a high probability of lower or higher 90-day mortality according to age, and other identified clusters', '3904 critically ill adult patients expected to receive invasive ventilation\u2009']","['dexmedetomidine (DEX', 'dexmedetomidine', 'DEX with usual care sedation', 'DEX']","['probability of increased mortality', '90-day mortality']","[{'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",3904.0,0.202491,DEX was associated with lower 90-day mortality compared to usual care in patients > ,"[{'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Shehabi', 'Affiliation': 'Monash Health School of Clinical Sciences, Monash University, Clayton, VIC, 3186, Australia. Yahya.shehabi@monashhealth.org.'}, {'ForeName': 'Ary', 'Initials': 'A', 'LastName': 'Serpa Neto', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Belinda D', 'Initials': 'BD', 'LastName': 'Howe', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Yaseen M', 'Initials': 'YM', 'LastName': 'Arabi', 'Affiliation': 'College of Medicine, King Saud Bin Abdulaziz University for Health Sciences and King Abdullah International Medical Research Center, King Abdulaziz Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bailey', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Frances E', 'Initials': 'FE', 'LastName': 'Bass', 'Affiliation': 'Critical Care Division, The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Suhaini Bin', 'Initials': 'SB', 'LastName': 'Kadiman', 'Affiliation': 'Department of Anesthesiology and Intensive Care, IJN-UTM Cardiovascular Engineering Center, National Heart Institute, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'McArthur', 'Affiliation': 'Department of Critical Care Medicine, Auckland City Hospital, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Reade', 'Affiliation': ""Faculty of Medicine, University of Queensland, Royal Brisbane and Women's Hospital, Brisbane, Australia.""}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Seppelt', 'Affiliation': 'Sydney Medical School-Nepean, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Takala', 'Affiliation': 'Department of Intensive Care, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Matt P', 'Initials': 'MP', 'LastName': 'Wise', 'Affiliation': 'Adult Critical Care, University Hospital of Wales, Cardiff, UK.'}, {'ForeName': 'Steve A', 'Initials': 'SA', 'LastName': 'Webb', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-021-06356-8'] 2428,33685241,Optimal design of cluster randomised trials with continuous recruitment and prospective baseline period.,"BACKGROUND Cluster randomised trials, like individually randomised trials, may benefit from a baseline period of data collection. We consider trials in which clusters prospectively recruit or identify participants as a continuous process over a given calendar period, and ask whether and for how long investigators should collect baseline data as part of the trial, in order to maximise precision. METHODS We show how to calculate and plot the variance of the treatment effect estimator for different lengths of baseline period in a range of scenarios, and offer general advice. RESULTS In some circumstances it is optimal not to include a baseline, while in others there is an optimal duration for the baseline. All other things being equal, the circumstances where it is preferable not to include a baseline period are those with a smaller recruitment rate, smaller intracluster correlation, greater decay in the intracluster correlation over time, or wider transition period between recruitment under control and intervention conditions. CONCLUSION The variance of the treatment effect estimator can be calculated numerically, and plotted against the duration of baseline to inform design. It would be of interest to extend these investigations to cluster randomised trial designs with more than two randomised sequences of control and intervention condition, including stepped wedge designs.",2021,"We show how to calculate and plot the variance of the treatment effect estimator for different lengths of baseline period in a range of scenarios, and offer general advice. ",[],[],[],[],[],[],,0.336036,"We show how to calculate and plot the variance of the treatment effect estimator for different lengths of baseline period in a range of scenarios, and offer general advice. ","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hooper', 'Affiliation': 'Centre for Clinical Trials & Methodology, Institute of Population Health Sciences, Queen Mary University of London, London, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Copas', 'Affiliation': 'MRC Clinical Trials Unit at University College London, London, UK.'}]","Clinical trials (London, England)",['10.1177/1740774520976564'] 2429,33684643,High-gamma oscillations as neurocorrelates of ADHD: A MEG crossover placebo-controlled study.,"Attention Deficit Hyperactive Disorder (ADHD) is a common neurobehavioral disorder with a significant and pervasive impact on patients' lives. Identifying neurophysiological correlates of ADHD is important for understanding its underlying mechanisms, as well as for improving clinical accuracy beyond cognitive and emotional factors. The present study focuses on finding a diagnostic stable neural correlate based on evaluating MEG resting state frequency bands. Twenty-two ADHD patients and 23 controls adults were blindly randomized to two methylphenidate/placebo evaluation days. On each evaluation day state anxiety was assessed, a 2N-back executive function task was performed, and resting state MEG brain activity was recorded at three timepoints. A frequency-based cluster analysis yielded higher high-gamma power for ADHD over posterior sensors and lower high-gamma power for ADHD over frontal-central sensors. These results were shown to be stable over three measurements, unaffected by methylphenidate treatment, and linked to cognitive accuracy and state anxiety. Furthermore, the differential high-gamma activity evidenced substantial ADHD diagnostic efficacy, comparable to the cognitive and emotional factors. These results indicate that resting state high-gamma activity is a promising, stable, valid and diagnostically-relevant neurocorrelate of ADHD. Due to the evolving understanding both in the cellular and network level of high-gamma oscillations, focusing future studies on this frequency band bears the potential for a better understanding of ADHD, thus advancing the specificity of the evaluation of the disorder and developing new tools for therapy.",2021,A frequency-based cluster analysis yielded higher high-gamma power for ADHD over posterior sensors and lower high-gamma power for ADHD over frontal-central sensors.,"['Twenty-two ADHD patients and 23 controls adults', 'ADHD']","['placebo', 'methylphenidate/placebo']","['substantial ADHD diagnostic efficacy', 'cognitive accuracy and state anxiety', 'resting state MEG brain activity']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0041671', 'cui_str': 'Attention Deficit Disorder'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}]","[{'cui': 'C0041671', 'cui_str': 'Attention Deficit Disorder'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0024489', 'cui_str': 'Magnetoencephalography'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}]",22.0,0.0257239,A frequency-based cluster analysis yielded higher high-gamma power for ADHD over posterior sensors and lower high-gamma power for ADHD over frontal-central sensors.,"[{'ForeName': 'Yair', 'Initials': 'Y', 'LastName': 'Dor-Ziderman', 'Affiliation': 'Gonda Brain Research Center, Bar Ilan University, Ramat-Gan, Israel; Edmond J. Safra Brain Research Center, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Maor', 'Initials': 'M', 'LastName': 'Zeev-Wolf', 'Affiliation': 'Department of Education & Zlotowski Center for Neuroscience, Ben Gurion University of the Negev, Israel.'}, {'ForeName': 'Efrat', 'Initials': 'E', 'LastName': 'Hirsch Klein', 'Affiliation': 'Gonda Brain Research Center, Bar Ilan University, Ramat-Gan, Israel.'}, {'ForeName': 'Dor', 'Initials': 'D', 'LastName': 'Bar-Oz', 'Affiliation': 'The Emotion-Cognition Research Center, Shalvata Mental Health Care Center, Hod-Hasharon, Israel; Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Uriel', 'Initials': 'U', 'LastName': 'Nitzan', 'Affiliation': 'The Emotion-Cognition Research Center, Shalvata Mental Health Care Center, Hod-Hasharon, Israel; Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Hagai', 'Initials': 'H', 'LastName': 'Maoz', 'Affiliation': 'The Emotion-Cognition Research Center, Shalvata Mental Health Care Center, Hod-Hasharon, Israel; Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Aviv', 'Initials': 'A', 'LastName': 'Segev', 'Affiliation': 'The Emotion-Cognition Research Center, Shalvata Mental Health Care Center, Hod-Hasharon, Israel; Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Goldstein', 'Affiliation': 'Gonda Brain Research Center, Bar Ilan University, Ramat-Gan, Israel; Department of Psychology, Bar Ilan University, Ramat-Gan, Israel.'}, {'ForeName': 'May', 'Initials': 'M', 'LastName': 'Koubi', 'Affiliation': 'The Emotion-Cognition Research Center, Shalvata Mental Health Care Center, Hod-Hasharon, Israel; Child and Adolescent Outpatient Clinic, Shalvata Mental Health Care Center, Hod-Hasharon, Israel; Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Shlomo', 'Initials': 'S', 'LastName': 'Mendelovic', 'Affiliation': 'The Emotion-Cognition Research Center, Shalvata Mental Health Care Center, Hod-Hasharon, Israel; Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Hila', 'Initials': 'H', 'LastName': 'Gvirts', 'Affiliation': 'Department of Behavioral Sciences and Psychology, Ariel University, Ariel, Israel.'}, {'ForeName': 'Yuval', 'Initials': 'Y', 'LastName': 'Bloch', 'Affiliation': 'The Emotion-Cognition Research Center, Shalvata Mental Health Care Center, Hod-Hasharon, Israel; Child and Adolescent Outpatient Clinic, Shalvata Mental Health Care Center, Hod-Hasharon, Israel; Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel. Electronic address: yuvalbloch10@gmail.com.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2021.02.050'] 2430,33684639,The effects of core stabilization exercise program in obese people awaiting bariatric surgery: A randomized controlled study.,"OBJECTIVE The aim of this study was the effects of the core stabilization exercise program (CSEP) and physical activity counseling on functional capacity, physical fitness, physical activity, fatigue and quality of life (QoL) in obese people awaiting bariatric surgery. METHODS Twenty-one patients were divided into two groups: an exercise group (n = 10) and a control group (n = 11). Both groups received physical activity counseling, but the exercise group also performed an 8-week CSEP. Functional capacity, physical fitness, physical activity, fatigue and QoL were assessed at baseline and after 8 weeks. RESULTS After eight weeks, results showed significant improvements in all parameters except for body composition for the exercise group, comparing to the control group (effect size = 0.40-0.87, p < 0.05). CONCLUSIONS Implementing an 8-week adding CSEP to physical activity counseling provided significant improvements in functional capacity, physical fitness, physical activity, fatigue and QoL compared to physical activity counseling in obese people awaiting bariatric surgery.",2021,"After eight weeks, results showed significant improvements in all parameters except for body composition for the exercise group, comparing to the control group (effect size = 0.40-0.87, p < 0.05). ","['obese people awaiting bariatric surgery', 'Twenty-one patients']","['core stabilization exercise program', 'exercise group', 'core stabilization exercise program (CSEP) and physical activity counseling', 'physical activity counseling, but the exercise group also performed an 8-week CSEP', 'physical activity counseling', 'CSEP to physical activity counseling']","['body composition', 'functional capacity, physical fitness, physical activity, fatigue and QoL', 'Functional capacity, physical fitness, physical activity, fatigue and QoL', 'functional capacity, physical fitness, physical activity, fatigue and quality of life (QoL']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",21.0,0.0204894,"After eight weeks, results showed significant improvements in all parameters except for body composition for the exercise group, comparing to the control group (effect size = 0.40-0.87, p < 0.05). ","[{'ForeName': 'Nilay', 'Initials': 'N', 'LastName': 'Arman', 'Affiliation': 'Istanbul University-Cerrahpasa, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Istanbul, Turkey. Electronic address: saimenilayarman@istanbul.edu.tr.'}, {'ForeName': 'Gulfidan', 'Initials': 'G', 'LastName': 'Tokgoz', 'Affiliation': ""Istanbul University-Cerrahpasa, Institute of Graduates Studies, Physiotherapy and Rehabilitation Master's Program, Istanbul, Turkey.""}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Seyit', 'Affiliation': 'University of Health Sciences, Faculty of Medicine, Bakirkoy Dr. Sadi Konuk Health Practice & Research Center, Department of General Surgery, Istanbul, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Karabulut', 'Affiliation': 'University of Health Sciences, Faculty of Medicine, Bakirkoy Dr. Sadi Konuk Health Practice & Research Center, Department of General Surgery, Istanbul, Turkey.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101342'] 2431,33684624,μ-Opioid antagonist naltrexone partially abolishes the antidepressant placebo effect and reduces OFC encoding of reinforcement.,"BACKGROUND Like placebo analgesia, the antidepressant placebo effect appears to involve cortical and subcortical endogenous opioid signaling, yet the mechanism through which opioid release impacts mood remains unclear. The orbitofrontal cortex (OFC) - which integrates various attributes of a stimulus to predict associated outcomes - has been implicated in placebo effects and is rich in μ-opioid receptors. We hypothesized that naltrexone blockade of μ-opioid receptors would blunt OFC-dependent antidepressant placebo effects. METHODS Twenty psychotropic-free patients with Major Depressive Disorder (MDD) completed a randomized, double-blind, placebo-controlled, crossover study of one oral dose of 50mg of naltrexone or matching placebo immediately before completing two sessions of the Antidepressant Placebo fMRI Task. This task manipulates placebo-associated expectancies and their reinforcement while assessing expected and actual mood improvement. RESULTS Behaviorally, manipulations of antidepressant placebo expectancies and their reinforcement had positive, interactive effects on participants' expectancy and mood ratings. The high expectancy condition recruited the dorsolateral and ventrolateral prefrontal cortex (dl/vlPFC), as well as dorsal attention stream regions. Interestingly, increased dl/vlPFC brain responses appeared to attenuate the antidepressant placebo effect. The administration of one oral dose of naltrexone, compared to placebo, partially abolished the interaction of the expectancy and reinforcement manipulation on mood and blocked reinforcement-induced responses in the right central OFC (cOFC). CONCLUSIONS Our results show preliminary evidence for the role of μ-opioid cOFC modulation in antidepressant placebo effects by positively biasing the value of placebo based on reinforcement and enhancing subsequent hedonic experiences.",2021,"The administration of one oral dose of naltrexone, compared to placebo, partially abolished the interaction of the expectancy and reinforcement manipulation on mood and blocked reinforcement-induced responses in the right central OFC (cOFC). ",['Twenty psychotropic-free patients with Major Depressive Disorder (MDD'],"['placebo', 'naltrexone', 'Antidepressant Placebo fMRI Task', 'naltrexone or matching placebo', 'μ-Opioid antagonist naltrexone']","['dl/vlPFC brain responses', ""participants' expectancy and mood ratings""]","[{'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0027410', 'cui_str': 'Opioid receptor antagonist'}]","[{'cui': 'C2983598', 'cui_str': 'Dorsolateral'}, {'cui': 'C3266730', 'cui_str': 'Ventrolateral'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",,0.308982,"The administration of one oral dose of naltrexone, compared to placebo, partially abolished the interaction of the expectancy and reinforcement manipulation on mood and blocked reinforcement-induced responses in the right central OFC (cOFC). ","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Peciña', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA. Electronic address: pecinam@upmc.edu.'}, {'ForeName': 'Jiazhou', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'National Institute of Health, Bethesda, MD, USA; University College London, London, UK.'}, {'ForeName': 'Thandi', 'Initials': 'T', 'LastName': 'Lyew', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Jordan F', 'Initials': 'JF', 'LastName': 'Karp', 'Affiliation': 'Department of Psychiatry, University of Arizona, Tucson, Arizona, USA.'}, {'ForeName': 'Alexandre Y', 'Initials': 'AY', 'LastName': 'Dombrovski', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}]",Biological psychiatry. Cognitive neuroscience and neuroimaging,['10.1016/j.bpsc.2021.02.009'] 2432,33684598,Motor cortex transcranial direct current stimulation effects on knee osteoarthritis pain in elderly subjects with dysfunctional descending pain inhibitory system: A randomized controlled trial.,"BACKGROUND Although evidence has indicated a positive effect of transcranial direct current stimulation (tDCS) on reducing pain, few studies have focused on the elderly population with knee osteoarthritis (KOA). OBJECTIVE To evaluate whether tDCS reduces KOA pain in elderly individuals with a dysfunctional descending pain inhibitory system (DPIS). METHODS In a double-blind trial, individuals ≥ 60 years with KOA pain and a dysfunctional DPIS, we randomly assigned patients to receive 15 daily sessions of 2 mA tDCS over the primary motor cortex (anode) and contralateral supraorbital area (cathode) (M1-SO) for 20 min or sham tDCS. Change in pain perception indexed by the Brief Pain Inventory (BPI) at the end of intervention was the primary outcome. Secondary outcomes included: disability, quantitative sensory testing, pain pressure threshold and conditioned pain modulation (CPM). Subjects were followed-up for 2 months. RESULTS Of the 104 enrolled subjects, with mean (SD) age of 73.9 (8.01) years and 88 (84.6%) female, 102 finished the trial. In the intention-to-treat analysis, the active tDCS group had a significantly greater reduction in BPI compared to the sham group (difference, 1.59; 95% CI, 0.95 to 2.23; P < 0.001; Cohen's d, 0.58); and, also a significantly greater improvement in CPM-pressure in the knee (P = 0.01) and CPM-pain in the hand (P = 0.01). These effects were not sustained at follow-up. The intervention was well tolerated, with no severe adverse effects. CONCLUSION M1-SO tDCS is associated with a moderate effect size in reducing pain in elderly patients with KOA after 15 daily sessions of stimulation. This intervention has also shown to modulate the DPIS.",2021,M1-SO tDCS is associated with a moderate effect size in reducing pain in elderly patients with KOA after 15 daily sessions of stimulation.,"['104 enrolled subjects, with mean(SD) age of 73.9(8.01) years and 88(84.6%) female, 102 finished the trial', 'elderly patients with KOA', 'elderly individuals with a dysfunctional descending pain inhibitory system (DPIS', 'Elderly Subjects with Dysfunctional Descending Pain Inhibitory System', 'individuals ≥ 60 years with KOA pain and a dysfunctional DPIS', 'elderly population with knee osteoarthritis (KOA']","['tDCS', 'M1-SO tDCS', 'Motor Cortex Transcranial Direct Current Stimulation', '15 daily sessions of 2mA tDCS over the primary motor cortex (anode) and contralateral supraorbital area (cathode) (M1-SO) for 20 min or sham tDCS', 'transcranial direct current stimulation (tDCS']","['Knee Osteoarthritis Pain', 'pain perception indexed by the Brief Pain Inventory (BPI', 'CPM-pain', 'CPM-pressure', 'KOA pain', 'disability, quantitative sensory testing, pain pressure threshold and conditioned pain modulation (CPM', 'BPI']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0230002', 'cui_str': 'Supraorbital area structure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0430838', 'cui_str': 'Quantitative sensory test'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",104.0,0.362551,M1-SO tDCS is associated with a moderate effect size in reducing pain in elderly patients with KOA after 15 daily sessions of stimulation.,"[{'ForeName': 'Daniela Regina Brandão', 'Initials': 'DRB', 'LastName': 'Tavares', 'Affiliation': 'Departament of Geriatrics and Gerontology, Federal University of São Paulo, São Paulo, SP, Brazil; Department of Evidence-Based Medicine, Brazilian Cochrane Centre, Federal University of São Paulo, São Paulo, SP, Brazil. Electronic address: daniela74_tavares@hotmail.com.'}, {'ForeName': 'Jane Erika Frazao', 'Initials': 'JEF', 'LastName': 'Okazaki', 'Affiliation': 'Department of Evidence-Based Medicine, Brazilian Cochrane Centre, Federal University of São Paulo, São Paulo, SP, Brazil. Electronic address: erikafrazao@gmail.com.'}, {'ForeName': 'Marcia Valéria de Andrade', 'Initials': 'MVA', 'LastName': 'Santana', 'Affiliation': 'Department of Evidence-Based Medicine, Brazilian Cochrane Centre, Federal University of São Paulo, São Paulo, SP, Brazil. Electronic address: lella-andrade@hotmail.com.'}, {'ForeName': 'Ana Carolina Pereira Nunes', 'Initials': 'ACPN', 'LastName': 'Pinto', 'Affiliation': 'Department of Evidence-Based Medicine, Brazilian Cochrane Centre, Federal University of São Paulo, São Paulo, SP, Brazil; Department of Physical Therapy, University of Pittsburgh, Fullbright Program, USA. Electronic address: anacarolinapnp@hotmail.com.'}, {'ForeName': 'Karina Kuraoka', 'Initials': 'KK', 'LastName': 'Tutiya', 'Affiliation': 'Departament of Geriatrics and Gerontology, Federal University of São Paulo, São Paulo, SP, Brazil. Electronic address: karina.tutiya@hotmail.com.'}, {'ForeName': 'Fernanda Martins', 'Initials': 'FM', 'LastName': 'Gazoni', 'Affiliation': 'Departament of Geriatrics and Gerontology, Federal University of São Paulo, São Paulo, SP, Brazil; Department of Evidence-Based Medicine, Brazilian Cochrane Centre, Federal University of São Paulo, São Paulo, SP, Brazil. Electronic address: fmgazoni@hotmail.com.'}, {'ForeName': 'Camila Bonin', 'Initials': 'CB', 'LastName': 'Pinto', 'Affiliation': 'Laboratory of Neuromodulation, Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: cboninpinto@gmail.com.'}, {'ForeName': 'Fania Cristina', 'Initials': 'FC', 'LastName': 'Santos', 'Affiliation': 'Departament of Geriatrics and Gerontology, Federal University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Fregni', 'Affiliation': 'Laboratory of Neuromodulation, Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: fregni.felipe@mgh.harvard.edu.'}, {'ForeName': 'Virginia Fernandes Moça', 'Initials': 'VFM', 'LastName': 'Trevisani', 'Affiliation': 'Department of Evidence-Based Medicine, Brazilian Cochrane Centre, Federal University of São Paulo, São Paulo, SP, Brazil; Department of Rheumatology, Santo Amaro University, São Paulo, SP, Brazil. Electronic address: vmoca@uol.com.br.'}]",Brain stimulation,['10.1016/j.brs.2021.02.018'] 2433,33687687,"Patient-Reported Outcomes from a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Repository Corticotropin Injection (Acthar ® Gel) for Persistently Active Systemic Lupus Erythematosus.","INTRODUCTION We assessed patient-reported outcomes from a multicenter, randomized, double-blind, placebo-controlled study of repository corticotropin injection (RCI; Acthar ® Gel) in patients with persistently active systemic lupus erythematosus (SLE) despite treatment with moderate-dose glucocorticoids. METHODS The trial enrolled adults with active SLE and moderate-to-severe rash and/or arthritis despite use of stable glucocorticoids (7.5 mg/day to 30 mg/day prednisone equivalent), antimalarials, and nonsteroidal anti-inflammatory drugs for ≥ 4 weeks and/or immunosuppressants for ≥ 8 weeks before screening. Patients were randomly assigned to 80 U of RCI or placebo subcutaneously every other day through week 4, then twice weekly through week 24. Primary analyses evaluated the change from baseline to week 24 in the Lupus Quality of Life (QoL) and Work Productivity and Activity Impairment (WPAI)-Lupus questionnaires. Post hoc analyses stratified results by baseline disease activity (SLE Disease Activity Index-2000 [SLEDAI-2K] < 10 or ≥ 10; Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI]-Activity < 11 or ≥ 11; and British Isles Lupus Assessment Group [BILAG]-2004 < 20 or ≥ 20) and by BILAG-based Combined Lupus Assessment (BICLA) response at weeks 20 and 24. RESULTS RCI treatment resulted in greater improvement in the LupusQoL pain domain at week 16 and planning domain at week 24 compared with placebo. Post hoc analyses demonstrated greater improvements with RCI in the pain, planning, and fatigue domains than with placebo at multiple time points in patients with higher disease activity by baseline SLEDAI-2K ≥ 10, CLASI-Activity ≥ 11, and BILAG-2004 ≥ 20 and/or in BICLA responders. Compared with placebo, RCI also resulted in greater improvements in percentage work time missed at week 24 in patients with baseline CLASI-Activity < 11 and in percentage impairment while working at week 16 in BICLA responders. CONCLUSIONS RCI may improve QoL and work productivity in patients who have persistently active SLE despite treatment with standard SLE therapy. TRIAL REGISTRATION ClinicalTrials.gov identifier NCT02953821.",2021,"Compared with placebo, RCI also resulted in greater improvements in percentage work time missed at week 24 in patients with baseline CLASI-Activity < 11 and in percentage impairment while working at week 16 in BICLA responders. ","['patients with persistently active systemic lupus erythematosus (SLE) despite treatment with moderate-dose glucocorticoids', 'patients who have persistently active SLE despite treatment with standard SLE therapy', 'Persistently Active Systemic Lupus Erythematosus', 'trial enrolled adults with active SLE and moderate-to-severe rash and/or arthritis despite use of\xa0stable glucocorticoids (7.5\xa0mg/day to 30\xa0mg/day prednisone equivalent), antimalarials, and nonsteroidal anti-inflammatory drugs for\u2009≥\u20094\xa0weeks']","['placebo', 'RCI or placebo', 'Repository Corticotropin Injection (Acthar ® Gel', 'placebo, RCI', 'repository corticotropin injection (RCI; Acthar ® Gel', 'Placebo']","['LupusQoL pain domain', 'Lupus Quality of Life (QoL) and Work Productivity and Activity Impairment (WPAI)-Lupus questionnaires', 'percentage work time missed', 'pain, planning, and fatigue domains', 'Cutaneous Lupus Erythematosus Disease Area and Severity Index', 'QoL and work productivity', 'BILAG-based Combined Lupus Assessment (BICLA) response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0003374', 'cui_str': 'Antimalarial'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0718234', 'cui_str': 'Acthar'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0024131', 'cui_str': 'Lupus vulgaris'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0024137', 'cui_str': 'Cutaneous lupus erythematosus'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.4567,"Compared with placebo, RCI also resulted in greater improvements in percentage work time missed at week 24 in patients with baseline CLASI-Activity < 11 and in percentage impairment while working at week 16 in BICLA responders. ","[{'ForeName': 'Anca D', 'Initials': 'AD', 'LastName': 'Askanase', 'Affiliation': 'Columbia University Irving Medical Center, New York, NY, USA. ada20@cumc.columbia.edu.'}, {'ForeName': 'George J', 'Initials': 'GJ', 'LastName': 'Wan', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Hampton, NJ, USA.'}, {'ForeName': 'Mary P', 'Initials': 'MP', 'LastName': 'Panaccio', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Hampton, NJ, USA.'}, {'ForeName': 'Enxu', 'Initials': 'E', 'LastName': 'Zhao', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Hampton, NJ, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Hampton, NJ, USA.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Bilyk', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Hampton, NJ, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Furie', 'Affiliation': 'Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.'}]",Rheumatology and therapy,['10.1007/s40744-021-00294-z'] 2434,33693945,"Glu298Asp (rs1799983) Polymorphism Influences Postprandial Vascular Reactivity and the Insulin Response to Meals of Varying Fat Composition in Postmenopausal Women: Findings from the Randomized, Controlled Dietary Intervention and VAScular function (DIVAS)-2 Study.","BACKGROUND Previous acute studies suggest the Glu298Asp polymorphism (rs1799983) may influence vascular reactivity in response to long-chain n-3 PUFA intake. However, the effects of this genotype on postprandial vascular function after meals rich in SFAs, n-6 PUFAs, and MUFAs are unclear. OBJECTIVES This study determined the impact of the Glu298Asp polymorphism on changes in vascular function and cardiometabolic risk biomarkers in response to sequential meals of varying fat composition. METHODS In a randomized, double-blind, crossover, acute study, 32 postmenopausal women (mean ± SD age: 58 ± 5 y; BMI: 25.9 ± 4.1 kg/m2) consumed mixed meals (breakfast: 0 min, 50 g fat; lunch: 330 min, 30 g fat) containing SFAs, n-6 PUFAs, or MUFAs on 3 occasions. Blood samples for cardiometabolic disease risk markers and real-time measures of vascular reactivity [including flow-mediated dilatation (FMD; primary outcome)] were collected/performed before and regularly for 480 min after breakfast. Participants were retrospectively genotyped for the Glu298Asp (rs1799983) polymorphism. Data were analyzed using linear mixed models. RESULTS For the postprandial %FMD response, a test fat × genotype interaction was observed for the AUC (P = 0.019) but not incremental AUC (IAUC), with the AUC being ∼24% greater after MUFA- than after SFA- and n-6 PUFA-rich meals in the Glu298 homozygotes (P ≤ 0.026). Test fat × genotype interactions were also evident for postprandial insulin (P ≤ 0.005), with the MUFA-rich meals demonstrating significantly higher AUC (12.8%/14.9%), IAUC (14.6%/20.0%), and maximum concentration (20.0%/34.5%) than the SFA- and n-6 PUFA-rich meals, respectively, in Asp298 carriers (P < 0.05). Genotype did not influence other study outcome measures in response to the test fats. CONCLUSIONS Our findings suggest the Glu298Asp polymorphism may represent a potential determinant of the inter-individual variability in postprandial responsiveness of %FMD and insulin to acute meal fat composition in postmenopausal women. Further studies are required to confirm these observations.This trial was registered at clinicaltrials.gov as NCT02144454.",2021,"Test fat × genotype interactions were also evident for postprandial insulin (P ≤ 0.005), with the MUFA-rich meals demonstrating significantly higher AUC (12.8%/14.9%), IAUC (14.6%/20.0%), and maximum concentration (20.0%/34.5%) than the SFA- and n-6 PUFA-rich meals, respectively, in Asp298 carriers (P < 0.05).","['Postmenopausal Women', '32 postmenopausal women (mean\xa0±', 'postmenopausal women']","['SFAs, n-6 PUFAs, or MUFAs', 'Glu298Asp polymorphism', 'mixed meals (breakfast: 0\xa0min, 50']","['postprandial insulin', 'AUC', 'IAUC', 'postprandial vascular function', 'maximum concentration']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0032615', 'cui_str': 'Polyunsaturated fatty acid'}, {'cui': 'C0015687', 'cui_str': 'Monounsaturated fatty acid'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",32.0,0.158856,"Test fat × genotype interactions were also evident for postprandial insulin (P ≤ 0.005), with the MUFA-rich meals demonstrating significantly higher AUC (12.8%/14.9%), IAUC (14.6%/20.0%), and maximum concentration (20.0%/34.5%) than the SFA- and n-6 PUFA-rich meals, respectively, in Asp298 carriers (P < 0.05).","[{'ForeName': 'Kumari M', 'Initials': 'KM', 'LastName': 'Rathnayake', 'Affiliation': 'Hugh Sinclair Unit of Human Nutrition, Institute for Food, Nutrition and Health and Institute for Cardiovascular and Metabolic Research, Department of Food & Nutritional Sciences, University of Reading, Whiteknights, Reading, United Kingdom.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Weech', 'Affiliation': 'Hugh Sinclair Unit of Human Nutrition, Institute for Food, Nutrition and Health and Institute for Cardiovascular and Metabolic Research, Department of Food & Nutritional Sciences, University of Reading, Whiteknights, Reading, United Kingdom.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Lovegrove', 'Affiliation': 'Hugh Sinclair Unit of Human Nutrition, Institute for Food, Nutrition and Health and Institute for Cardiovascular and Metabolic Research, Department of Food & Nutritional Sciences, University of Reading, Whiteknights, Reading, United Kingdom.'}, {'ForeName': 'Kim G', 'Initials': 'KG', 'LastName': 'Jackson', 'Affiliation': 'Hugh Sinclair Unit of Human Nutrition, Institute for Food, Nutrition and Health and Institute for Cardiovascular and Metabolic Research, Department of Food & Nutritional Sciences, University of Reading, Whiteknights, Reading, United Kingdom.'}]",The Journal of nutrition,['10.1093/jn/nxaa394'] 2435,33691499,"Mycobacterium vaccae Nebulization in the Treatment of COVID-19: A Randomized, Double-Blind, Placebo-Controlled Trial.","Background: Severe acute respiratory syndrome coronavirus 2 infection is associated with strong infectiousness and has no effective therapy. We aimed to explore the efficacy and safety of Mycobacterium vaccae nebulization in the treatment of Coronavirus Disease 2019 (COVID-19). Methods: In this randomized, double-blind, placebo-controlled clinical trial, we included 31 adult patients with moderate COVID-19 who were admitted to the Fourth People's Hospital of Nanning (Nanning, China) between January 22, 2020 and February 17, 2020. Patients were randomly divided into two groups: group A (standard care group) and group B ( M. vaccae in combination with standard care group). The primary outcome was the time interval from admission to viral RNA negative conversion (oropharyngeal swabs were used in this study). Secondary outcomes included chest computed tomography (CT), mortality, length of hospital stay, complications during treatment, and so on. Patients were followed up to 4 weeks after discharge (reexamination of viral RNA, chest CT, etc.). Results: Nucleic acid test negative conversion time in group B was shorter than that in group A (2.9 days [2.7-8.7] vs. 6.8 days [3.3-13.8]; p  = 0.045). No death and no conversion to severe or critical cases were observed in both groups. Two weeks after discharge, neither ""relapse"" nor ""return to positive"" cases were found. Four weeks after discharge, it was found that there was no case of "" relapse "" or ""return to positive"" in group B, and 1 patient in group A showed ""return to positive"", but there was no clinical manifestation and imaging progression. No adverse reactions related to M. vaccae were found during observation period. Conclusion: M. vaccae treatment might shorten the time interval from admission to viral RNA negative conversion, which might be beneficial to the prevention and treatment of COVID-19. Clinical Trial Registration: ChiCTR2000030016.",2021,"Four weeks after discharge, it was found that there was no case of "" relapse "" or ""return to positive"" in group B, and 1 patient in group A showed ""return to positive"", but there was no clinical manifestation and imaging progression.","['Severe acute respiratory syndrome coronavirus', 'Coronavirus Disease 2019 (COVID-19', 'group B', ""31 adult patients with moderate COVID-19 who were admitted to the Fourth People's Hospital of Nanning (Nanning, China) between January 22, 2020 and February 17, 2020"", 'COVID-19']","['group A (standard care group) and group B ( M. vaccae in combination with standard care group', 'Placebo', 'placebo']","['time interval from admission to viral RNA negative conversion (oropharyngeal swabs', 'chest computed tomography (CT), mortality, length of hospital stay, complications during treatment, and so on', ' relapse "" or ""return', 'relapse"" nor ""return', 'adverse reactions', 'No death and no conversion to severe or critical cases']","[{'cui': 'C1175743', 'cui_str': 'SARS coronavirus'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0035736', 'cui_str': 'Viral RNA'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0183753', 'cui_str': 'Swab'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0868928', 'cui_str': 'Case'}]",31.0,0.458716,"Four weeks after discharge, it was found that there was no case of "" relapse "" or ""return to positive"" in group B, and 1 patient in group A showed ""return to positive"", but there was no clinical manifestation and imaging progression.","[{'ForeName': 'Yan-Rong', 'Initials': 'YR', 'LastName': 'Lin', 'Affiliation': ""Department of Respiratory and Critical Care Medicine, The Fourth People's Hospital of Nanning, Nanning, Guangxi, China.""}, {'ForeName': 'Feng-Yao', 'Initials': 'FY', 'LastName': 'Wu', 'Affiliation': ""Department of Respiratory and Critical Care Medicine, The Fourth People's Hospital of Nanning, Nanning, Guangxi, China.""}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Xiao', 'Affiliation': 'Department of Respiratory Medicine, Guangxi Medical University, Nanning, Guangxi, China.'}, {'ForeName': 'Jian-Lin', 'Initials': 'JL', 'LastName': 'Huang', 'Affiliation': 'Department of Respiratory Medicine, Guangxi Medical University, Nanning, Guangxi, China.'}, {'ForeName': 'Bei-Bei', 'Initials': 'BB', 'LastName': 'Gong', 'Affiliation': ""Department of Respiratory and Critical Care Medicine, The Fourth People's Hospital of Nanning, Nanning, Guangxi, China.""}, {'ForeName': 'You-Ling', 'Initials': 'YL', 'LastName': 'Li', 'Affiliation': ""Department of Respiratory and Critical Care Medicine, The Fourth People's Hospital of Nanning, Nanning, Guangxi, China.""}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Lu', 'Affiliation': ""Department of Respiratory and Critical Care Medicine, The Fourth People's Hospital of Nanning, Nanning, Guangxi, China.""}, {'ForeName': 'Xiao-Hong', 'Initials': 'XH', 'LastName': 'Jiang', 'Affiliation': 'Department of Respiratory Medicine, Guangxi Medical University, Nanning, Guangxi, China.'}, {'ForeName': 'Qi-Xiang', 'Initials': 'QX', 'LastName': 'Sun', 'Affiliation': 'Department of Respiratory Medicine, Guangxi Medical University, Nanning, Guangxi, China.'}, {'ForeName': 'Jian-Feng', 'Initials': 'JF', 'LastName': 'Zhang', 'Affiliation': 'Department of Emergency, Guangxi Medical University, Nanning, Guangxi, China.'}, {'ForeName': 'Jun-Tao', 'Initials': 'JT', 'LastName': 'Hu', 'Affiliation': 'Department of Respiratory Medicine, Guangxi Medical University, Nanning, Guangxi, China.'}, {'ForeName': 'Yong-Xiang', 'Initials': 'YX', 'LastName': 'Zhao', 'Affiliation': 'Collaborative Innovation Center for Targeting Tumor Theranostics, Guangxi Medical University, Nanning, Guangxi, China.'}, {'ForeName': 'Chao-Qian', 'Initials': 'CQ', 'LastName': 'Li', 'Affiliation': 'Department of Respiratory Medicine, Guangxi Medical University, Nanning, Guangxi, China.'}]",Journal of aerosol medicine and pulmonary drug delivery,['10.1089/jamp.2020.1628'] 2436,33691454,Efficacy comparison between toric intraocular lens and aspheric intraocular lens plus steep-axis incision in cataract patients with low corneal astigmatism.,"BACKGROUND The present study aimed to evaluate and compare the efficacy of toric intraocular lens (IOL) implantation and aspheric IOL implantation with steep-axis incision for correcting mild to moderate corneal astigmatism in cataract patients. METHODS A prospective, single-center, open label, randomized, two-arm study was designed. Cataract patients with corneal astigmatism of 1.0-2.0D were enrolled and divided into test and control groups. The test group had the AcrySof® IQ Toric IOL implanted and the control group had the AcrySof® IQ IOL implanted with a steep-axis corneal incision. All patients underwent examinations of uncorrected distance visual acuity (UCDVA), corrected distance visual acuity (CDVA), subjective refraction, and corneal astigmatism before surgery and at the 1-day, 1-month, and 3-month follow-ups. Vector astigmatism analysis was evaluated using the Alpins method. RESULTS We enrolled 26 eyes of 20 patients in the study, with 13 eyes in each group. The test group had better vision than the control group at the 3-month follow-up and had more cases with a UCDVA of 20/20 (10/13 vs. 4/13). The surgically induced astigmatism (SIA) vector of the test group was higher than that of the control group (1.22±0.64 vs. 0.84±0.45). The correction index of the test group was closer to 1 compared to that of the control group (0.7 vs. 0.46). Approximately 85% of patients in the test group had an angle of error within -15° to 15°. However, only 23% of patients in the control group were within that range. CONCLUSIONS Though steep-axis corneal incision was cost-saving and easy-to perform, its astigmatismcorrecting efficacy was not as good as the Toric IOL implantation for cataract patients with low to moderate corneal astigmatism.",2021,The surgically induced astigmatism (SIA) vector of the test group was higher than that of the control group (1.22±0.64 vs. 0.84±0.45).,"['enrolled 26 eyes of 20 patients in the study, with 13 eyes in each group', 'Cataract patients with corneal astigmatism of 1.0-2.0D', 'cataract patients with low to moderate corneal astigmatism', 'cataract patients with low corneal astigmatism', 'cataract patients']","['toric intraocular lens (IOL) implantation and aspheric IOL implantation with steep-axis incision', 'AcrySof® IQ IOL implanted with a steep-axis corneal incision', 'toric intraocular lens and aspheric intraocular lens plus steep-axis incision']","['better vision', 'correction index', 'uncorrected distance visual acuity (UCDVA), corrected distance visual acuity (CDVA), subjective refraction, and corneal astigmatism before surgery', 'surgically induced astigmatism (SIA) vector']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0339682', 'cui_str': 'Regular astigmatism - corneal'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C1522223', 'cui_str': 'Intraocular route'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C1301318', 'cui_str': 'Subjective refraction'}, {'cui': 'C0339682', 'cui_str': 'Regular astigmatism - corneal'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C1689961', 'cui_str': 'Surgically induced astigmatism'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}]",26.0,0.0227728,The surgically induced astigmatism (SIA) vector of the test group was higher than that of the control group (1.22±0.64 vs. 0.84±0.45).,"[{'ForeName': 'Ziyuan', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Ophthalmology, Peking University Third Hospital, Beijing Key Laboratory of Restoration of Damaged Ocular Nerve, Beijing, China.'}, {'ForeName': 'Ren', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': 'Department of Ophthalmology, Peking University Third Hospital, Beijing Key Laboratory of Restoration of Damaged Ocular Nerve, Beijing, China.'}, {'ForeName': 'Aihua', 'Initials': 'A', 'LastName': 'Ding', 'Affiliation': 'Department of Ophthalmology, Peking University Third Hospital, Beijing Key Laboratory of Restoration of Damaged Ocular Nerve, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, Peking University Third Hospital, Beijing Key Laboratory of Restoration of Damaged Ocular Nerve, Beijing, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Yanxiu', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Ophthalmology, Peking University Third Hospital, Beijing Key Laboratory of Restoration of Damaged Ocular Nerve, Beijing, China. yxs0283@yahoo.com.'}]",Annals of palliative medicine,['10.21037/apm-20-1434'] 2437,33691439,The effectiveness of electro-acupuncture combined with dyclonine hydrochloride in relieving the side effects of gastroscopy: a controlled trial.,"BACKGROUND The present study aimed to explore the effectiveness of electro-acupuncture (EA) in combination with a local anesthetic used in Western medicine in preventing the side effects of gastroscopy. METHODS A sample group of 150 patients were divided into three groups based on treatment methods: an EA group, a dyclonine hydrochloride mucilage group, and a combined treatment group. In the EA group, EA stimulation was given at the Hegu, Neiguan, and Zusanli acupoints; in the dyclonine hydrochloride mucilage group, patients took 10 mL of dyclonine hydrochloride mucilage orally; in the combined treatment group, prevention of side effects was attempted by administration of both acupuncture and oral local anesthetic. The incidences of nausea, emesis, salivation, cough, restlessness, and breath holding during gastroscopy were observed and recorded for the three groups. Mean arterial pressure, heart rate, and oxygen saturation were recorded before the examination, and changes in these measures were recorded as the gastroscope passed through the pylorus and after the examination. The visual analogue scale (VAS) values of nausea and emesis, the rate of successful first-pass intubation, and the time of gastroscopy were also recorded. Statistical analysis was performed using R-3.5.3 software. RESULTS Incidences of side effects (e.g., nausea, emesis, salivation, restlessness, and breath holding) during the examination were lower in the combined treatment group than in the EA group and the dyclonine hydrochloride mucilage group (P<0.05 and P<0.01, respectively). Furthermore, the changes in heart rate and oxygen saturation when the gastroscope passed through the pylorus and after the examination were better in the combined treatment group than in the EA group and dyclonine hydrochloride mucilage group (P<0.01). The VAS values of nausea and emesis, the first-pass success rate, and examination duration were also better for the combined treatment group than for the other two groups (P<0.05 and P<0.01). CONCLUSIONS EA combined with local anesthesia with dyclonine hydrochloride mucilage can alleviate side effects during gastroscopy, reduce patient pain, and improve the efficiency of the procedure.",2021,"The VAS values of nausea and emesis, the first-pass success rate, and examination duration were also better for the combined treatment group than for the other two groups (P<0.05 and P<0.01). ",['A sample group of 150 patients'],"['acupuncture and oral local anesthetic', 'electro-acupuncture combined with dyclonine hydrochloride', 'dyclonine hydrochloride mucilage', 'electro-acupuncture (EA', 'dyclonine hydrochloride']","['Mean arterial pressure, heart rate, and oxygen saturation', 'patient pain', 'side effects (e.g., nausea, emesis, salivation, restlessness, and breath holding', 'nausea, emesis, salivation, cough, restlessness, and breath holding during gastroscopy', 'VAS values of nausea and emesis, the first-pass success rate, and examination duration', 'heart rate and oxygen saturation', 'visual analogue scale (VAS) values of nausea and emesis, the rate of successful first-pass intubation, and the time of gastroscopy']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0304455', 'cui_str': 'Dyclonine hydrochloride'}]","[{'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0036104', 'cui_str': 'Salivary secretion'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0235744', 'cui_str': 'Interrupted breathing'}, {'cui': 'C0017195', 'cui_str': 'Endoscopy of stomach'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444693', 'cui_str': 'First pass'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",150.0,0.0367767,"The VAS values of nausea and emesis, the first-pass success rate, and examination duration were also better for the combined treatment group than for the other two groups (P<0.05 and P<0.01). ","[{'ForeName': 'Jian-Ming', 'Initials': 'JM', 'LastName': 'Chen', 'Affiliation': ""Department of Intensive Medicine, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China; Department of Gastroenterology, The 81th Group Army Hospital of the Chinese People's Liberation Army, Zhangjiakou, China.""}, {'ForeName': 'Dong-Dong', 'Initials': 'DD', 'LastName': 'Li', 'Affiliation': ""Department of Cardiology, Tangdu Hospital, Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Yi-Shan', 'Initials': 'YS', 'LastName': 'Chen', 'Affiliation': 'Department of Intensive Medicine, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Lian', 'Affiliation': 'Department of Intensive Medicine, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiao-Peng', 'Initials': 'XP', 'LastName': 'Wang', 'Affiliation': 'Department of Intensive Medicine, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yu-Hong', 'Initials': 'YH', 'LastName': 'Guo', 'Affiliation': 'Department of Intensive Medicine, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiao-Long', 'Initials': 'XL', 'LastName': 'Xu', 'Affiliation': 'Department of Intensive Medicine, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China.'}, {'ForeName': 'Po', 'Initials': 'P', 'LastName': 'Huang', 'Affiliation': 'Department of Intensive Medicine, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China.'}, {'ForeName': 'Teng-Fei', 'Initials': 'TF', 'LastName': 'Chen', 'Affiliation': 'Department of Intensive Medicine, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Gastroenterology, The 81th Group Army Hospital of the Chinese People's Liberation Army, Zhangjiakou, China.""}, {'ForeName': 'Qing-Quan', 'Initials': 'QQ', 'LastName': 'Liu', 'Affiliation': 'Department of Intensive Medicine, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China. drliu_lqq1060@163.com.'}]",Annals of palliative medicine,['10.21037/apm-20-831'] 2438,33711123,Chronic pain after open inguinal hernia repair: expertise-based randomized clinical trial of heavyweight or lightweight mesh.,"BACKGROUND There is a shortage of high-quality studies regarding choice of mesh in open anterior inguinal hernia repair in relation to long-term chronic pain. The authors hypothesized that heavyweight compared with lightweight mesh causes increased postoperative pain. METHODS An RCT was undertaken between 2007 and 2009 at two sites in Sweden. Men aged 25 years or older with an inguinal hernia evaluated in the outpatient clinic were randomized in an unblinded fashion to heavyweight or lightweight mesh for open anterior inguinal hernia repair. Data on pain affecting daily activities, as measured by the Short-Form Inguinal Pain Questionnaire 9-12 years after surgery, were collected as the primary outcome. Differences between groups were evaluated by generalized odds and numbers needed to treat. RESULTS A total of 412 patients were randomized; 363 were analysed with 320 questionnaires sent out. A total of 271 questionnaires (84.7 per cent) were returned; of these, 121 and 150 patients were in the heavyweight and lightweight mesh groups respectively. Pain affecting daily activities was more pronounced in patients randomized to heavyweight versus lightweight mesh (generalized odds 1.33, 95 per cent c.i. 1.10 to 1.61). This translated into a number needed to treat of 7.06 (95 per cent c.i. 4.28 to 21.44). Two reoperations for recurrence were noted in the heavyweight mesh group, and one in the lightweight mesh group. CONCLUSION A large-pore lightweight mesh causes significantly less pain affecting daily activities a decade after open anterior inguinal hernia repair. Registration number: NCT00451893 (http://www.clinicaltrials.gov).",2021,"Pain affecting daily activities was more pronounced in patients randomized to heavyweight versus lightweight mesh (generalized odds 1.33, 95 per cent c.i.","['A total of 412 patients were randomized; 363 were analysed with 320 questionnaires sent out', 'Men aged 25 years or older with an inguinal hernia evaluated in the outpatient clinic']","['heavyweight or lightweight mesh', 'heavyweight or lightweight mesh for open anterior inguinal hernia repair', 'lightweight mesh']","['Pain affecting daily activities', 'Chronic pain', 'postoperative pain']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",412.0,0.585594,"Pain affecting daily activities was more pronounced in patients randomized to heavyweight versus lightweight mesh (generalized odds 1.33, 95 per cent c.i.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rutegård', 'Affiliation': 'Department of Surgical and Perioperative Sciences, Surgery, Umeå University, Umeå, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lindqvist', 'Affiliation': 'Department of Surgical and Perioperative Sciences, Surgery, Umeå University, Umeå, Sweden.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Svensson', 'Affiliation': 'Department of Surgical and Perioperative Sciences, Surgery, Umeå University, Umeå, Sweden.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Nordin', 'Affiliation': 'Department of Surgical and Perioperative Sciences, Surgery, Östersund Research Unit, Umeå University, Östersund, Sweden.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Haapamäki', 'Affiliation': 'Department of Surgical and Perioperative Sciences, Surgery, Umeå University, Umeå, Sweden.'}]",The British journal of surgery,['10.1093/bjs/znaa049'] 2439,33711106,Prevention of biliary fistula after partial hepatectomy by transcystic biliary drainage: randomized clinical trial.,,2021,,['biliary fistula after partial hepatectomy by transcystic biliary drainage'],[],[],"[{'cui': 'C0005417', 'cui_str': 'Fistula of bile duct'}, {'cui': 'C0193398', 'cui_str': 'Partial hepatectomy'}, {'cui': 'C0400745', 'cui_str': 'Biliary drainage'}]",[],[],,0.313592,,"[{'ForeName': 'Wafi', 'Initials': 'W', 'LastName': 'Attaallah', 'Affiliation': 'Department of General Surgery, Marmara University School of Medicine, Istanbul, Turkey.'}]",The British journal of surgery,['10.1093/bjs/znaa099'] 2440,33716034,Genetic Predictors of Response to Acupuncture or Cognitive Behavioral Therapy for Insomnia in Cancer Survivors: An Exploratory Analysis.,"CONTEXT Insomnia is a common problem affecting cancer survivors. While effective nonpharmacological treatments are available, it is unknown whether individual genetic characteristics influence treatment response. OBJECTIVES We conducted an exploratory analysis of genetic associations with insomnia treatment response in a randomized trial of cognitive behavioral therapy for insomnia (CBT-I) vs. acupuncture in a heterogeneous group of cancer survivors. METHODS We successfully genotyped 136 participants for 11 genetic variants. Successful treatment response was defined as a reduction in Insomnia Severity Index score of at least eight points from baseline to week 8. We used Fisher exact tests to evaluate associations between genotype and treatment success for each treatment arm, for an alpha level of 0.05 with unadjusted and Holm-Bonferroni-adjusted P-values. RESULTS We found that more carriers of COMT rs4680-A alleles responded to acupuncture compared to the GG carriers (63.6% vs. 27.8%, P = 0.013). More carriers of the NFKB2 rs1056890 CC genotype also responded to acupuncture compared to TT or CT carriers (72.2% vs. 38.9%, P = 0.009). There were no significant differences found between any of the tested gene variants and CBT-I response. None of the results remained statistically significant after adjustment for multiple testing. CONCLUSION In cancer survivors, specific variants in the COMT and NFKB2 genes are potentially associated with response to acupuncture but not to CBT-I. Confirming these preliminary results will help inform precision insomnia management for cancer survivors.",2021,"More carriers of the NFKB2 rs1056890 CC genotype also responded to acupuncture compared to TT or CT carriers (72.2% vs. 38.9%, p=0.009).","['Cancer Survivors', '136 participants for 11 genetic variants', 'heterogeneous group of cancer survivors']","['acupuncture', 'cognitive behavioral therapy', 'Acupuncture or Cognitive Behavioral Therapy']",['Insomnia Severity Index score'],"[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0242960', 'cui_str': 'Heterogeneity, Genetic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C4706228', 'cui_str': 'ISI (Insomnia Severity Index) score'}]",136.0,0.0872704,"More carriers of the NFKB2 rs1056890 CC genotype also responded to acupuncture compared to TT or CT carriers (72.2% vs. 38.9%, p=0.009).","[{'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Genovese', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA; The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Gehrman', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'MingXiao', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Integrative Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Yuelin', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Sheila N', 'Initials': 'SN', 'LastName': 'Garland', 'Affiliation': ""Departments of Psychology and Oncology, Memorial University of Newfoundland, St. John's, Newfoundland, Canada.""}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Orlow', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Jun J', 'Initials': 'JJ', 'LastName': 'Mao', 'Affiliation': 'Integrative Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA. Electronic address: maoj@mskcc.org.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2021.03.002'] 2441,33715402,Red Blood Cell Distribution Width Trajectory During a Multicomponent Exercise in Hospitalized Older Adults: A Secondary Analysis of a Randomized Clinical Trial.,,2021,Our aim was to investigate the association of RDW levels and the response to an individualized exercise program in hospitalized older adults.,"['Hospitalized Older Adults', 'hospitalized older adults', 'very old hospitalized patients']","['Multicomponent Exercise', 'individualized exercise program']","['RDW levels', 'Red Cell Distribution Width (RDW) Trajectory']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0427460', 'cui_str': 'Red cell distribution width determination'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0571936,Our aim was to investigate the association of RDW levels and the response to an individualized exercise program in hospitalized older adults.,"[{'ForeName': 'Nicolás', 'Initials': 'N', 'LastName': 'Martínez-Velilla', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de, Navarra (UPNA), IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Robinson', 'Initials': 'R', 'LastName': 'Ramírez-Vélez', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de, Navarra (UPNA), IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Mikel L', 'Initials': 'ML', 'LastName': 'Sáez de Asteasu', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de, Navarra (UPNA), IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Fabricio', 'Initials': 'F', 'LastName': 'Zambom-Ferraresi', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de, Navarra (UPNA), IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'García-Hermoso', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de, Navarra (UPNA), IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Itxaso', 'Initials': 'I', 'LastName': 'Marín-Epelde', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de, Navarra (UPNA), IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de, Navarra (UPNA), IdiSNA, Pamplona, Spain.'}]",Rejuvenation research,['10.1089/rej.2020.2405'] 2442,33684919,Metabolic Effects of Growth Hormone Treatment in Short Prepubertal Children: A Double-Blinded Randomized Clinical Trial.,"INTRODUCTION Growth hormone (GH) is a central hormone for regulating linear growth during childhood and also highly involved in the metabolism of lipids, carbohydrates, and protein. However, few studies report on how treatment with GH during childhood influences metabolic parameters. Our aim was to investigate metabolic effects of different doses of GH in short children with GH peak levels in the low to normal range. DESIGN Thirty-five prepubertal short children (<-2.5 SDS), aged 7-10 years, with peak levels of GH between 7 and 14 μg/L during an arginine-insulin tolerance test, were randomized to 3 different doses (11/33/100 μg/kg/day) of GH treatment for 2 years. Auxological and metabolic investigations were performed. These included metabolites in blood and interstitial microdialysis fluid, dual-energy X-ray absorptiometry, frequently sampled intravenous glucose tolerance test (FSIVGTT), and stable isotope examinations of rates of glucose production and lipolysis. RESULTS At 24 months, the high-dose group (HD) had higher fasting insulin compared with the standard-dose (SD) and low-dose (LD) groups (HD: 111.7 vs. SD: 61.2 and LD: 46.0 pmol/L [p < 0.001]) and showed signs of insulin resistance (HOMA-IR, HD: 4.20 vs. SD: 2.17 and LD: 1.71 (LD) [p < 0.001]). The FSIVGTT also demonstrated higher acute insulin response (p < 0.05). Few other metabolic differences were found at 24 months, but a decreased insulin sensitivity index (Si) could already be seen at 12 months for both SD and HD compared with the LD group (p < 0.05). CONCLUSION Treatment with GH resulted in a dose-dependent decrease in insulin sensitivity, demonstrated by higher levels of fasting insulin and signs of insulin resistance in both HOMA indices and FSIVGTT examinations.",2020,"Treatment with GH resulted in a dose-dependent decrease in insulin sensitivity, demonstrated by higher levels of fasting insulin and signs of insulin resistance in both HOMA indices and FSIVGTT examinations.","['short children with GH peak levels in the low to normal range', 'Thirty-five prepubertal short children (<-2.5 SDS), aged 7-10 years, with peak levels of GH between 7 and 14 μg/L during an arginine-insulin tolerance test', 'Short Prepubertal Children']","['GH', 'GH treatment', 'FSIVGTT', 'Growth Hormone Treatment', 'Growth hormone (GH']","['acute insulin response', 'higher fasting insulin', 'fasting insulin and signs of insulin resistance', 'signs of insulin resistance', 'insulin sensitivity index (Si', 'insulin sensitivity']","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086715', 'cui_str': 'Normal range'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0063632', 'cui_str': 'insulin, Arg(B29)-'}, {'cui': 'C0201777', 'cui_str': 'Tolerance test'}]","[{'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0021911', 'cui_str': 'Intravenous Glucose Tolerance'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.199038,"Treatment with GH resulted in a dose-dependent decrease in insulin sensitivity, demonstrated by higher levels of fasting insulin and signs of insulin resistance in both HOMA indices and FSIVGTT examinations.","[{'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Tidblad', 'Affiliation': ""Department of Women's and Children's Health, Division of Pediatric Endocrinology, Karolinska Institutet, Stockholm, Sweden, anders.tidblad@ki.se.""}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Gustafsson', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Marcus', 'Affiliation': 'Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Ritzén', 'Affiliation': ""Department of Women's and Children's Health, Division of Pediatric Endocrinology, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Klas', 'Initials': 'K', 'LastName': 'Ekström', 'Affiliation': ""Department of Women's and Children's Health, Division of Pediatric Endocrinology, Karolinska Institutet, Stockholm, Sweden.""}]",Hormone research in paediatrics,['10.1159/000513518'] 2443,33684370,"Cetuximab, docetaxel, and cisplatin versus platinum, fluorouracil, and cetuximab as first-line treatment in patients with recurrent or metastatic head and neck squamous-cell carcinoma (GORTEC 2014-01 TPExtreme): a multicentre, open-label, randomised, phase 2 trial.","BACKGROUND Results from a phase 2 trial of the TPEx chemotherapy regimen (docetaxel-platinum-cetuximab) showed promising results, with a median overall survival of 14·0 months in first-line recurrent or metastatic head and neck squamous-cell carcinoma (HNSCC). We therefore aimed to compare the efficacy and safety of the TPEx regimen with the standard of care EXTREME regimen (platinum-fluorouracil-cetuximab) in this setting. METHODS This was a multicentre, open-label, randomised, phase 2 trial, done in 68 centres (cancer centres, university and general hospitals, and private clinics) in France, Spain, and Germany. Eligible patients were aged 18-70 years with histologically confirmed recurrent or metastatic HNSCC unsuitable for curative treatment; had at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1; and had an Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less. Participants were randomly assigned (1:1) using the TenAlea website by investigators or delegated clinical research associates to the TPEx regimen or the EXTREME regimen, with minimisation by ECOG performance status, type of disease evolution, previous cetuximab treatment, and country. The TPEx regimen consisted of docetaxel 75 mg/m 2 and cisplatin 75 mg/m 2 , both intravenously on day 1, and cetuximab on days 1, 8, and 15 (intravenously 400 mg/m 2 on day 1 of cycle 1 and 250 mg/m 2 weekly subsequently). Four cycles were repeated every 21 days with systematic granulocyte colony-stimulating factor (G-CSF) support at each cycle. In case of disease control after four cycles, intravenous cetuximab 500 mg/m 2 was continued every 2 weeks as maintenance therapy until progression or unacceptable toxicity. The EXTREME regimen consisted of fluorouracil 4000 mg/m 2 on day 1-4, cisplatin 100 mg/m 2 on day 1, and cetuximab on days 1, 8, and 15 (400 mg/m 2 on day 1 of cycle 1 and 250 mg/m 2 weekly subsequently) all delivered intravenously. Six cycles were delivered every 21 days followed by weekly 250 mg/m 2 cetuximab as maintenance therapy in case of disease control. G-CSF support was not mandatory per the protocol in the EXTREME regimen. The primary endpoint was overall survival in the intention-to-treat population; safety was analysed in all patients who received at least one dose of chemotherapy or cetuximab. Enrolment is closed and this is the final analysis. This study is registered at ClinicalTrials.gov, NCT02268695. FINDINGS Between Oct 10, 2014, and Nov 29, 2017, 541 patients were enrolled and randomly assigned to the two treatment regimens (271 to TPEx, 270 to EXTREME). Two patients in the TPEx group had major deviations in consent forms and were not included in the final analysis. Median follow-up was 34·4 months (IQR 26·6-44·8) in the TPEx group and 30·2 months (25·5-45·3) in the EXTREME group. At data cutoff, 209 patients had died in the TPEx group and 218 had died in the EXTREME group. Overall survival did not differ significantly between the groups (median 14·5 months [95% CI 12·5-15·7] in the TPEx group and 13·4 months [12·2-15·4] in the EXTREME group; hazard ratio 0·89 [95% CI 0·74-1·08]; p=0·23). 214 (81%) of 263 patients in the TPEx group versus 246 (93%) of 265 patients in the EXTREME group had grade 3 or worse adverse events during chemotherapy (p<0·0001). In the TPEx group, 118 (45%) of 263 patients had at least one serious adverse event versus 143 (54%) of 265 patients in the EXTREME group. 16 patients in the TPEx group and 21 in the EXTREME group died in association with adverse events, including seven patients in each group who had fatal infections (including febrile neutropenia). Eight deaths in the TPEx group and 11 deaths in the EXTREME group were assessed as treatment related, most frequently sepsis or septic shock (four in each treatment group). INTERPRETATION Although the trial did not meet its primary endpoint, with no significant improvement in overall survival with TPEx versus EXTREME, the TPEx regimen had a favourable safety profile. The TPEx regimen could provide an alternative to standard of care with the EXTREME regimen in the first-line treatment of patients with recurrent or metastatic HNSCC, especially for those who might not be good candidates for up-front pembrolizumab treatment. FUNDING Merck Santé and Chugai Pharma.",2021,Overall survival did not differ significantly between the groups (median 14·5 months [95% CI 12·5-15·7] in the TPEx group and 13·4 months [12·2-15·4] in the EXTREME group; hazard ratio 0·89 [95% CI 0·74-1·08]; p=0·23).,"['Between Oct 10, 2014, and Nov 29, 2017, 541 patients', 'metastatic head and neck squamous-cell carcinoma (HNSCC', '16 patients in the', '68 centres (cancer centres, university and general hospitals, and private clinics) in France, Spain, and Germany', 'patients with recurrent or metastatic head and neck squamous-cell carcinoma (GORTEC 2014-01 TPExtreme', 'Eligible patients were aged 18-70 years with histologically confirmed recurrent or metastatic HNSCC unsuitable for curative treatment; had at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1; and had an Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less', 'patients with recurrent or metastatic HNSCC, especially for those who might not be good candidates for up-front pembrolizumab treatment']","['chemotherapy or cetuximab', 'fluorouracil 4000 mg/m 2 on day 1-4, cisplatin 100 mg/m 2 on day 1, and cetuximab', 'intravenous cetuximab', 'TPEx', 'Cetuximab, docetaxel, and cisplatin versus platinum, fluorouracil, and cetuximab', 'TPEx regimen with the standard of care EXTREME regimen (platinum-fluorouracil-cetuximab', 'TPEx chemotherapy regimen (docetaxel-platinum-cetuximab', 'docetaxel 75 mg/m 2 and cisplatin']","['overall survival', 'overall survival in the intention-to-treat population; safety', 'fatal infections (including febrile neutropenia', 'efficacy and safety', 'serious adverse event', 'Overall survival', 'major deviations', 'adverse events', 'grade 3 or worse adverse events']","[{'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0744620', 'cui_str': 'Squamous cell carcinoma of head and neck metastatic'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C3842327', 'cui_str': '4000'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}]",541.0,0.058274,Overall survival did not differ significantly between the groups (median 14·5 months [95% CI 12·5-15·7] in the TPEx group and 13·4 months [12·2-15·4] in the EXTREME group; hazard ratio 0·89 [95% CI 0·74-1·08]; p=0·23).,"[{'ForeName': 'Joël', 'Initials': 'J', 'LastName': 'Guigay', 'Affiliation': ""Department of Medical Oncology and Research, Centre Antoine Lacassagne, FHU Oncoage, University Côte d'Azur, Nice, France. Electronic address: joel.guigay@nice.unicancer.fr.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Aupérin', 'Affiliation': 'Biostatistic and Epidemiology Unit, Gustave Roussy, Oncostat 1018 INSERM, labeled Ligue Contre le Cancer, University Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Fayette', 'Affiliation': 'Department of Medical Oncology, University of Lyon, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Esma', 'Initials': 'E', 'LastName': 'Saada-Bouzid', 'Affiliation': ""Department of Medical Oncology, Centre Antoine Lacassagne, FHU Oncoage, University Côte d'Azur, Nice, France.""}, {'ForeName': 'Cédrik', 'Initials': 'C', 'LastName': 'Lafond', 'Affiliation': 'Department of Medical Oncology, ILC Centre Jean Bernard/Clinique Victor Hugo, Le Mans, France.'}, {'ForeName': 'Miren', 'Initials': 'M', 'LastName': 'Taberna', 'Affiliation': ""Department of Medical Oncology, Institut Català de Oncologia, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Lionnel', 'Initials': 'L', 'LastName': 'Geoffrois', 'Affiliation': 'Department of Medical Oncology, Institut de Cancérologie de Lorraine, Nancy, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Martin', 'Affiliation': 'Department of Medical Oncology, Clinique des Ormeaux, Le Havre, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Capitain', 'Affiliation': ""Department of Medical Oncology, Institut de Cancérologie de l'Ouest Paul Papin, Angers, France.""}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Cupissol', 'Affiliation': 'Department of Medical Oncology, Institut du Cancer de Montpellier, Montpellier, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Castanie', 'Affiliation': 'Department of Medical Oncology, Hôpital Privé le Confluent, Sainte Catherine de Sienne, Nantes, France.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Vansteene', 'Affiliation': ""Department of Medical Oncology, Institut de Cancérologie de l'Ouest René Gauducheau, Nantes, France.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Schafhausen', 'Affiliation': 'Department of Medical Oncology, Universitätsklinikum Hamburg Eppendorf Hubertus Wald Tumorzentrum, Hamburg, Germany.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Johnson', 'Affiliation': 'Department of Medical Oncology, Centre François Baclesse, Caen, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Even', 'Affiliation': 'Department of Head and Neck Oncology, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sire', 'Affiliation': 'Department of Medical Oncology, Centre Hospitalier de Bretagne Sud, Lorient, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Duplomb', 'Affiliation': 'Department of Medical Oncology, HCL, Hôpital de la Croix Rousse, Lyon, France.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Evrard', 'Affiliation': 'Department of Medical Oncology, CHU, Université de Poitiers, Poitiers, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Delord', 'Affiliation': 'Department of Medical Oncology, Institut Claudius Regaud, Toulouse, France.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Laguerre', 'Affiliation': 'Department of Medical Oncology, Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Zanetta', 'Affiliation': 'Department of Medical Oncology, Centre Georges-François Leclerc, Dijon, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Chevassus-Clément', 'Affiliation': 'Biostatistic and Epidemiology Unit, Gustave Roussy, Oncostat 1018 INSERM, labeled Ligue Contre le Cancer, University Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Aldéric', 'Initials': 'A', 'LastName': 'Fraslin', 'Affiliation': 'Biostatistic and Epidemiology Unit, Gustave Roussy, Oncostat 1018 INSERM, labeled Ligue Contre le Cancer, University Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Louat', 'Affiliation': 'GORTEC, Tours, France.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Sinigaglia', 'Affiliation': 'GORTEC, Tours, France.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Keilholz', 'Affiliation': 'Charité Comprehensive Cancer Center, Charité, Berlin, Germany.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bourhis', 'Affiliation': 'GORTEC, Tours, France.'}, {'ForeName': 'Ricard', 'Initials': 'R', 'LastName': 'Mesia', 'Affiliation': ""Department of Medical Oncology, Institut Català de Oncologia, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30755-5'] 2444,33684310,Reducing contrast medium dose with low photon energy images in renal dual-energy spectral CT angiography and adaptive statistical iterative reconstruction (ASIR).,"OBJECTIVE To evaluate the value of using low energy (keV) images in renal dual-energy spectral CT angiography (CTA) and adaptive statistical iterative reconstruction (ASIR) to reduce contrast medium dose. METHODS 40 patients with renal CTA on a Discovery CT750HD were randomly divided into two groups: 20 cases (Group A) with 600 mgI kg -1 and 20 cases (Group B) with 300 mgI kg -1 . The scan protocol for both groups was: dual-energy mode with mA selection for noise index of 10 HU, pitch 1.375:1, rotating speed 0.6 s/r. Images were reconstructed at 0.625 mm thickness with 40%ASIR, Group A used the conventional 70keV monochromatic images, and Group B used monochromatic images from 40 to 70 keV at 5 keV interval for analysis. The CT values and standard deviation (SD) values of the renal artery and erector spine in the plain and arterial phases were measured with the erector spine SD value representing image noise. The enhancement degree of the renal artery (ΔCT = CT(arterial) -CT(plain)), signal-to-noise ratio (SNR=CT renal-artery /SD renal-artery ) and contrast-to-noise ratio (CNR=(CT renal-artery -CT erector spine )/SD erector-spine ) were calculated. The single factor analysis of variance was used to analyze the difference of ΔCT, SNR and CNR among image groups with p < 0.05 being statistically significant. The subjective image scores of the groups were assessed blindly by two experienced physicians using a 5-point system and the score consistency was compared by the κ test. RESULTS Contrast medium dose in the 300 mgI kg -1 group was reduced by 50% compared with the 600 mgI kg -1 group, while radiation dose was similar between the two groups. The subjective scores were 4.00 ± 0.65, 4.50 ± 0.60 and 3.70 ± 0.80 for images at 70 keV (600 mgI kg -1 group), 40 keV (300 mgI kg -1 group) and 45 keV (300 mgI kg -1 group), respectively with good consistency between the two reviewers ( p > 0.05). The 40 keV images in the 300 mgI kg -1 group had similar ΔCT (469.77 ± 86.95 HU vs 398.54 ± 73.68 HU) and CNR (15.52 ± 3.32 vs 18.78 ± 6.71) values as the 70 keV images in the 600 mgI kg -1 ) group but higher SNR values (30.19 ± 4.41 vs 16.91 ± 11.12, p < 0,05). CONCLUSION Contrast dose may be reduced by 50% while maintaining image quality by using lower energy images combined with ASIR in renal dual-energy CTA. ADVANCES IN KNOWLEDGE Combined with ASIR and energy spectrum, can reduce the amount of contrast dose in renal CTA.",2021,"RESULTS Contrast medium dose in the 300 mgI kg -1 group was reduced by 50% compared with the 600 mgI kg -1 group, while radiation dose was similar between the two groups.",['40 patients with renal CTA on a Discovery CT750HD'],"['SD', 'low energy (keV) images in renal dual-energy spectral CT angiography (CTA) and adaptive statistical iterative reconstruction (ASIR']","['CT values and standard deviation (SD) values of the renal artery and erector spine', 'subjective image scores', 'SNR values', 'enhancement degree of the renal artery (ΔCT = CT(arterial) -CT(plain)), signal-to-noise ratio (SNR=CT renal-artery /SD renal-artery ) and contrast-to-noise ratio (CNR=(CT renal-artery -CT erector spine ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0035065', 'cui_str': 'Structure of renal artery'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",40.0,0.0270912,"RESULTS Contrast medium dose in the 300 mgI kg -1 group was reduced by 50% compared with the 600 mgI kg -1 group, while radiation dose was similar between the two groups.","[{'ForeName': 'Xirong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Techniques, Shaanxi University of Chinese medicine, Xianyang, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Techniques, Shaanxi University of Chinese medicine, Xianyang, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Yu', 'Affiliation': 'Department of Medical Techniques, Shaanxi University of Chinese medicine, Xianyang, China.'}, {'ForeName': 'Zhanli', 'Initials': 'Z', 'LastName': 'Ren', 'Affiliation': 'Department of Medical Techniques, Shaanxi University of Chinese medicine, Xianyang, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Tian', 'Affiliation': 'Department of Medical Techniques, Shaanxi University of Chinese medicine, Xianyang, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Tian', 'Affiliation': 'Department of Medical Techniques, Shaanxi University of Chinese medicine, Xianyang, China.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'Department of Medical Techniques, Shaanxi University of Chinese medicine, Xianyang, China.'}, {'ForeName': 'Taiping', 'Initials': 'T', 'LastName': 'He', 'Affiliation': 'Department of Medical Techniques, Shaanxi University of Chinese medicine, Xianyang, China.'}, {'ForeName': 'Changyi', 'Initials': 'C', 'LastName': 'Guo', 'Affiliation': 'Department of Medical Techniques, Shaanxi University of Chinese medicine, Xianyang, China.'}]",The British journal of radiology,['10.1259/bjr.20200974'] 2445,33704505,[Impact of handover of anesthesia care on adverse postoperative outcomes-The HandiCAP trial].,,2021,,[],['anesthesia care'],[],[],"[{'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]",[],,0.167063,,"[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Massoth', 'Affiliation': ''}, {'ForeName': 'Khaschayar', 'Initials': 'K', 'LastName': 'Saadat-Gilani', 'Affiliation': ''}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Meersch', 'Affiliation': 'Klinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie, Universitätsklinikum Münster, Albert-Schweitzer-Campus 1, Geb. A1, 48149, Münster, Deutschland. meersch@uni-muenster.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Der Anaesthesist,['10.1007/s00101-021-00940-9'] 2446,33704389,Effect of Clear vs Standard Covered Masks on Communication With Patients During Surgical Clinic Encounters: A Randomized Clinical Trial.,"Importance During the COVID-19 pandemic, wearing masks has become necessary, especially within health care. However, to our knowledge, the consequences of mask wearing on communication between surgeons and patients have not been studied. Objective To evaluate the effects of clear vs standard covered masks on communication during surgical clinic encounters. Design This randomized clinical trial examined communication between surgeons and their patients when surgeons wore clear vs covered masks in surgical outpatient clinics at a single academic medical center. New patients were recruited from participating surgeons' clinic schedules. Interventions Surgeons wore either clear masks or covered masks for each clinic visit with a new patient, based on a per-visit randomization plan. Main Outcomes and Measures The primary outcome measures included patient perceptions of (1) surgeon communication and (2) trust in surgeons, as well as (3) quantitative assessments and (4) qualitative assessments regarding patient impressions of the surgeon's mask. After the clinic encounter, patients completed a verbal survey including validated Clinician and Group Consumer Assessment of Healthcare Providers and Systems questions. Additional questions involved surgeon empathy, trust, and the patient's impression of the surgeon's mask. Data were analyzed by comparing patient data in the clear vs covered groups using Cochran-Mantel-Haenszel tests, and comments were analyzed for themes. Results Two hundred patients were enrolled from 15 surgeons' clinics spanning 7 subspecialties. When surgeons wore a clear mask, patients rated their surgeons higher for providing understandable explanations (clear, 95 of 100 [95%] vs covered, 78 of 100 [78%]; P < .001), demonstrating empathy (clear, 99 [99%] vs covered, 85 [85%]; P < .001), and building trust (clear, 94 [94%] vs covered, 72 [72%]; P < .001). Patients preferred clear masks (clear, 100 [100%] vs covered, 72 [72%]; P < .001), citing improved surgeon communication and appreciation for visualization of the face. Conversely, 8 of 15 surgeons (53%) were unlikely to choose the clear mask over their standard covered mask. Conclusions and Relevance This randomized clinical trial demonstrates that patients prefer to see their surgeon's face. Surgeons who wore clear masks were perceived by patients to be better communicators, have more empathy, and elicit greater trust. Because masks will remain part of the health care landscape for some time, deliberate attention to preserving communication within the surgeon-patient relationship is warranted. Trial Registration ClinicalTrials.gov Identifier: NCT04595695.",2021,"Patients preferred clear masks (clear, 100 [100%] vs covered, 72 [72%]; P < .001), citing improved surgeon communication and appreciation for visualization of the face.","[""patients prefer to see their surgeon's face"", ""New patients were recruited from participating surgeons' clinic schedules"", 'surgeons and their patients when surgeons wore clear vs covered masks in surgical outpatient clinics at a single academic medical center', ""Two hundred patients were enrolled from 15 surgeons' clinics spanning 7 subspecialties""]","['Clear vs Standard Covered Masks', 'clear vs standard covered masks', 'Interventions\n\n\nSurgeons wore either clear masks or covered masks']","['surgeon communication and appreciation for visualization of the face', 'building trust', ""patient perceptions of (1) surgeon communication and (2) trust in surgeons, as well as (3) quantitative assessments and (4) qualitative assessments regarding patient impressions of the surgeon's mask""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C1720477', 'cui_str': 'When'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}]","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0024861', 'cui_str': 'Mask'}]",200.0,0.185898,"Patients preferred clear masks (clear, 100 [100%] vs covered, 72 [72%]; P < .001), citing improved surgeon communication and appreciation for visualization of the face.","[{'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Kratzke', 'Affiliation': 'Department of Surgery, University of North Carolina, Chapel Hill.'}, {'ForeName': 'Marcy E', 'Initials': 'ME', 'LastName': 'Rosenbaum', 'Affiliation': 'Department of Family Medicine, University of Iowa, Iowa City.'}, {'ForeName': 'Chase', 'Initials': 'C', 'LastName': 'Cox', 'Affiliation': 'Department of Surgery, University of North Carolina, Chapel Hill.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Ollila', 'Affiliation': 'Department of Surgery, University of North Carolina, Chapel Hill.'}, {'ForeName': 'Muneera R', 'Initials': 'MR', 'LastName': 'Kapadia', 'Affiliation': 'Department of Surgery, University of North Carolina, Chapel Hill.'}]",JAMA surgery,['10.1001/jamasurg.2021.0836'] 2447,33711180,Randomised study: effects of the 5-HT 4 receptor agonist felcisetrag vs placebo on gut transit in patients with gastroparesis.,"BACKGROUND Gastroparesis is defined by delayed gastric emptying with associated symptoms in the absence of mechanical obstruction. AIM To evaluate pharmacokinetics and pharmacodynamics of felcisetrag, a highly selective 5-HT 4 receptor agonist, on total gut transit in patients with documented delayed gastric emptying of solids. METHODS Single-centre, placebo-controlled study of 36 participants receiving placebo, 0.1mg, 0.3mg or 1.0mg of felcisetrag I.V. infusion, daily, for 3 days. At baseline, each participant completed a 4h, 99m Tc-egg meal (300 kcal, 30% fat) gastric emptying test. Following infusion (Day 2), gastric, small bowel and colonic transit of solids were measured over 48h (same meal plus 111 In-charcoal delivered in methacrylate-coated capsule). Samples were collected for pharmacokinetics. The primary endpoint was gastric emptying T 1/2 . Statistical analysis used baseline parameters as covariates (ANCOVA). RESULTS Patients (22 idiopathic, 14 diabetic gastroparesis) were randomised to felcisetrag (0.1 mg, n = 10; 0.3 mg, n = 9; 1.0 mg, n = 7) or placebo (n = 10). Compared to placebo, felcisetrag significantly accelerated gastric emptying T 1/2 , colonic filling at 6h, and 10% small bowel transit time (overall P < 0.01; all three doses individually Bonferroni corrected P < 0.05) for all three measurements. Ascending colon emptying (T 1/2 ) was significantly accelerated (all doses), and colonic transit at 48 hours was accelerated with 0.1 mg and 0.3 mg felcisetrag compared to placebo. Pharmacokinetic results were dose proportional. Felcisetrag was well tolerated with no clinically significant findings from clinical laboratory, vital signs or ECG. CONCLUSION I.V. felcisetrag significantly accelerated gastric, small bowel and colonic transit in patients with gastroparesis, and should be further evaluated for short-term treatment of gastric and intestinal motility disorders. ClinicalTrials.gov #NCT03281577.",2021,"Compared to placebo, felcisetrag significantly accelerated gastric emptying T 1/2 , colonic filling at 6h, and 10% small bowel transit time (overall P ","['36 participants receiving', 'patients with documented delayed gastric emptying of solids', 'patients with gastroparesis', 'Patients (22 idiopathic, 14 diabetic gastroparesis']","['placebo, 0.1mg, 0.3mg or 1.0mg of felcisetrag I.V. infusion', 'placebo', '5-HT 4 receptor agonist felcisetrag vs placebo', 'Tc-egg meal']","['gastric emptying T 1/2 , colonic filling', 'small bowel transit time', 'Ascending colon emptying', 'gastric emptying T 1/2 ', 'colonic transit', 'accelerated gastric, small bowel and colonic transit']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0267176', 'cui_str': 'Gastroparesis with diabetes mellitus'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C2987634', 'cui_str': 'Receptor agonist'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0227375', 'cui_str': 'Ascending colon structure'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}]",36.0,0.0919374,"Compared to placebo, felcisetrag significantly accelerated gastric emptying T 1/2 , colonic filling at 6h, and 10% small bowel transit time (overall P ","[{'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Chedid', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Brandler', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'Arndt', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Vijayvargiya', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Xiao Jing', 'Initials': 'XJ', 'LastName': 'Wang', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Duane', 'Initials': 'D', 'LastName': 'Burton', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'W Scott', 'Initials': 'WS', 'LastName': 'Harmsen', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Jenifer', 'Initials': 'J', 'LastName': 'Siegelman', 'Affiliation': 'Takeda Pharmaceuticals International Co, Cambridge, MA, USA.'}, {'ForeName': 'Chunlin', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Takeda Pharmaceuticals International Co, Cambridge, MA, USA.'}, {'ForeName': 'Yinzhong', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Takeda Pharmaceuticals International Co, Cambridge, MA, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Almansa', 'Affiliation': 'Takeda Pharmaceuticals International Co, Cambridge, MA, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Dukes', 'Affiliation': 'Takeda Pharmaceuticals International Co, Cambridge, MA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Camilleri', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.16304'] 2448,33713618,Transcatheter aortic valve replacement in low-risk patients: 2-year results from the LRT trial.,"BACKGROUND Previous studies from the Low Risk TAVR (LRT) trial demonstrated that transcatheter aortic valve replacement (TAVR) is safe and feasible in low-risk patients, with excellent 30-day and 1-year outcomes. The objective of this study was to report clinical outcomes and the impact of 30-day hypoattenuated leaflet thickening (HALT) on structural valve deterioration (SVD) 2 years after TAVR. METHODS The LRT trial was the first Food and Drug Administration-approved Investigational Device Exemption trial in the United States to evaluate the safety and feasibility of TAVR in low-risk patients with symptomatic severe tricuspid aortic stenosis (AS). Valve hemodynamics and SVD by echo were recorded 30 days, 1 year, and 2 years post-TAVR. RESULTS The LRT trial enrolled 200 low-risk patients to receive TAVR. Their mean age was 73.6 years and 61.5% were men. At 2-year follow-up, the mortality rate was 4.2%; the cardiovascular death rate was 1.6%. The disabling stroke rate was 1.1%, permanent pacemaker implantation rate was 8.6%, and 4 patients (2.2%) presented with endocarditis (2 between years 1 and 2). Of the 14% of TAVR subjects who had evidence of HALT at 30 days, there was no impact on valve hemodynamics, endocarditis or stroke at 2 years. CONCLUSIONS TAVR for low-risk patients with symptomatic severe tricuspid AS is safe at 2 years. The presence of HALT at 30 days did not impact the early hemodynamic improvements nor the durability of the valve structure.",2021,"At 2-year follow-up, the mortality rate was 4.2%; the cardiovascular death rate was 1.6%.","['Low-Risk Patients', 'Their mean age was 73.6 years and 61.5% were men', '200 low-risk patients to receive', 'low-risk patients with symptomatic severe tricuspid aortic stenosis (AS']","['30-day hypoattenuated leaflet thickening (HALT', 'TAVR', 'transcatheter aortic valve replacement (TAVR', 'Transcatheter Aortic Valve Replacement']","['cardiovascular death rate', 'disabling stroke rate', 'valve hemodynamics, endocarditis or stroke', 'mortality rate', 'structural valve deterioration (SVD', 'permanent pacemaker implantation rate', 'Valve hemodynamics and SVD', 'durability of the valve structure']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0443327', 'cui_str': 'Tricuspid'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205400', 'cui_str': 'Thickened'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0014118', 'cui_str': 'Endocarditis'}, {'cui': 'C4285833', 'cui_str': 'Structural valve deterioration'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",200.0,0.154301,"At 2-year follow-up, the mortality rate was 4.2%; the cardiovascular death rate was 1.6%.","[{'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Waksman', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC. Electronic address: ron.waksman@medstar.net.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Torguson', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Giorgio A', 'Initials': 'GA', 'LastName': 'Medranda', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Shea', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gordon', 'Affiliation': 'Division of Cardiology, Miriam Hospital, Providence, RI.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Ehsan', 'Affiliation': 'Division of Cardiothoracic Surgery, Lifespan Cardiovascular Institute, Providence, RI.'}, {'ForeName': 'Sean R', 'Initials': 'SR', 'LastName': 'Wilson', 'Affiliation': 'Department of Medicine, Valley Hospital, Ridgewood, NJ.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Levitt', 'Affiliation': 'Department of Cardiology, HCA Virginia Health System, Richmond, VA.'}, {'ForeName': 'Chiwon', 'Initials': 'C', 'LastName': 'Hahn', 'Affiliation': 'Department of Cardiothoracic Surgery, HCA Virginia Health System, Richmond, VA.'}, {'ForeName': 'Puja', 'Initials': 'P', 'LastName': 'Parikh', 'Affiliation': 'Department of Medicine, Stony Brook Hospital, Stony Brook, NY.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bilfinger', 'Affiliation': 'Department of Surgery, Stony Brook Hospital, Stony Brook, NY.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Butzel', 'Affiliation': 'Cardiovascular Service Line, Maine Medical Center, Portland, ME.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Buchanan', 'Affiliation': 'Cardiovascular Service Line, Maine Medical Center, Portland, ME.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Hanna', 'Affiliation': 'St. John Heart Institute Cardiovascular Consultants, St. John Health System, Tulsa, OK.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Buchbinder', 'Affiliation': 'Foundation for Cardiovascular Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Asch', 'Affiliation': 'MedStar Health Research Institute, MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Gaby', 'Initials': 'G', 'LastName': 'Weissman', 'Affiliation': 'Department of Cardiology, MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Itsik', 'Initials': 'I', 'LastName': 'Ben-Dor', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Shults', 'Affiliation': 'Department of Cardiac Surgery, MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Hector M', 'Initials': 'HM', 'LastName': 'Garcia-Garcia', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Lowell F', 'Initials': 'LF', 'LastName': 'Satler', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Rogers', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC; Cardiovascular Branch, Division of Intramural Research, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD.'}]",American heart journal,['10.1016/j.ahj.2021.03.006'] 2449,33710588,Effect of Complex Weight-Reducing Interventions on Rhythm Control in Obese Individuals with Atrial Fibrillation Following Catheter Ablation: A Study Protocol.,"INTRODUCTION Obesity and atrial fibrillation (AF) pose a significant burden on healthcare systems worldwide. Reduction of body weight has been documented to reduce the risk of AF. Little is known about the effect of different weight-reducing interventions including bariatric surgery in obese individuals on the risk of arrhythmia recurrence following catheter ablation (CA) for AF, and about the pathophysiological mechanisms linking these two conditions. METHODS The Effect of complex weigHt-reducing interventiOns on rhythm control in oBese subjects wITh Atrial Fibrillation (HOBIT-AF) is a single-blinded, parallel-group randomised controlled trial with 18-month follow-up to assess the effect of complex weight-reducing interventions supported by the use of smart technologies and bariatric surgery on the arrhythmia burden in obese individuals following CA for AF. One hundred and sixty individuals (age 18-70 years, body mass index ≥ 30 kg/m 2 ) will be randomised in a 1:1 fashion to undergo a structured weight reduction programme and sleeve gastrectomy (when indicated and preferred by the patient) aiming to achieve greater than 10% weight reduction from baseline (intervention group) or standard post-ablation medical care (control group). Two-week continuous ECG monitoring will be used 3 and 18 months after CA to assess the arrhythmia burden. Other investigations will include transthoracic echocardiography with quantification of epicardial adipose tissue, and markers of low-grade inflammation and circulating adipokines. PLANNED OUTCOMES The main objective is to assess the effect of complex weight-reducing interventions on the arrhythmia burden and quality of life. Subgroup analyses to identify patient subgroups preferentially benefiting from weight loss related to a decrease in arrhythmia burden will be performed. Exploratory objectives will include investigation of potential mechanisms linking weight reduction with amelioration of arrhythmia burden such as changes in markers of low-grade inflammation, circulating adipokines, cytokines, monocytes or reduction of epicardial adipose tissue volume. TRIAL REGISTRATION NCT04560387.",2021,"The Effect of complex weigHt-reducing interventiOns on rhythm control in oBese subjects wITh Atrial Fibrillation (HOBIT-AF) is a single-blinded, parallel-group randomised controlled trial with 18-month follow-up to assess the effect of complex weight-reducing interventions supported by the use of smart technologies and bariatric surgery on the arrhythmia burden in obese individuals following CA for AF.","['obese individuals', 'oBese subjects wITh Atrial Fibrillation (HOBIT-AF', 'One hundred and sixty individuals (age 18-70\xa0years, body mass index\u2009≥\u200930\xa0kg/m 2 ', 'obese individuals following CA for AF', 'Obese Individuals with Atrial Fibrillation Following Catheter Ablation']","['structured weight reduction programme and sleeve gastrectomy (when indicated and preferred by the patient) aiming to achieve greater than 10% weight reduction from baseline (intervention group) or standard post-ablation medical care (control group', 'complex weight-reducing interventions', 'complex weigHt-reducing interventiOns', 'Complex Weight-Reducing Interventions', 'smart technologies and bariatric surgery', 'catheter ablation (CA']","['arrhythmia burden', 'arrhythmia burden and quality of life']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}]","[{'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",160.0,0.0871576,"The Effect of complex weigHt-reducing interventiOns on rhythm control in oBese subjects wITh Atrial Fibrillation (HOBIT-AF) is a single-blinded, parallel-group randomised controlled trial with 18-month follow-up to assess the effect of complex weight-reducing interventions supported by the use of smart technologies and bariatric surgery on the arrhythmia burden in obese individuals following CA for AF.","[{'ForeName': 'Kristýna', 'Initials': 'K', 'LastName': 'Štolbová', 'Affiliation': 'Department of Cardiology, Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Novodvorský', 'Affiliation': 'Diabetes Centre, Institute for Clinical and Experimental Medicine (IKEM), Vídeňská 1958, 140 21, Prague 4, Czech Republic.'}, {'ForeName': 'Iva', 'Initials': 'I', 'LastName': 'Jakubíková', 'Affiliation': 'Diabetes Centre, Institute for Clinical and Experimental Medicine (IKEM), Vídeňská 1958, 140 21, Prague 4, Czech Republic.'}, {'ForeName': 'Iveta', 'Initials': 'I', 'LastName': 'Dvořáková', 'Affiliation': 'Centre for Experimental Medicine, IKEM, Prague, Czech Republic.'}, {'ForeName': 'Miloš', 'Initials': 'M', 'LastName': 'Mráz', 'Affiliation': 'Diabetes Centre, Institute for Clinical and Experimental Medicine (IKEM), Vídeňská 1958, 140 21, Prague 4, Czech Republic.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wichterle', 'Affiliation': 'Department of Cardiology, Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Kautzner', 'Affiliation': 'Department of Cardiology, Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Haluzík', 'Affiliation': 'Diabetes Centre, Institute for Clinical and Experimental Medicine (IKEM), Vídeňská 1958, 140 21, Prague 4, Czech Republic. halm@ikem.cz.'}]",Advances in therapy,['10.1007/s12325-021-01667-0'] 2450,33706247,Effect of early withdrawal of phenobarbitone on the recurrence of neonatal seizures: An open-label randomized controlled trial.,"BACKGROUND The long-term administration of phenobarbitone in neonates may be associated with adverse neurological outcome. The timing of stopping phenobarbitone maintenance after acute seizure control in neonates is a matter of debate. OBJECTIVES To study the effect of early withdrawal of phenobarbitone on recurrence of neonatal seizures. STUDY DESIGN Open-label randomized controlled trial. PARTICIPANTS Outborn neonates (≥34 weeks of gestation to <28 days of postnatal period) with seizures (n = 221) admitted to Neonatal unit in Pediatric emergency of a tertiary care hospital in north India over 1 year. INTERVENTION After a loading dose of phenobarbitone (20 mg/kg), neonates who remained seizure free for at least 12 h were enrolled after written informed consent from parents, and randomized (computer generated block randomization) to 'phenobarbitone withdrawal group' (n = 112) where phenobarbitone maintenance was stopped and 'phenobarbitone continued group' (n = 109) where phenobarbitone maintenance was continued until discharge and further as per clinician's discretion. OUTCOMES The primary outcome was seizure recurrence until discharge and secondary outcomes were time to reach full enteral feeds, duration of hospital stay, abnormal neurological status at discharge, and mortality in two groups. RESULTS The baseline variables were comparable in 2 groups. The incidence of seizure recurrence was similar in the phenobarbitone withdrawal and phenobarbitone continued groups (50% vs. 37.6%, respectively, p = 0.078). Among secondary outcomes, the phenobarbitone withdrawal and continued groups had similar time to reach full enteral feeds (4.02 days vs. 4.2 days, p = 0.75), duration of hospital stay (6.3 days vs. 6.5 days, p = 0.23), abnormal neurological status at discharge (45.6% vs. 38%, p = 0.39), and mortality (11.6% vs. 8.3%, p = 0.50). CONCLUSION Early withdrawal of phenobarbitone in neonatal seizures does not lead to a significant increase in the rate of seizure recurrence.",2021,does not lead to a significant increase in the rate of seizure recurrence.,"['neonatal seizures', 'neonates who remained seizure free for at least 12\u202fh were enrolled after written informed consent from parents', 'Outborn neonates (≥34\u202fweeks of gestation to <28\u202fdays of postnatal period) with seizures (n\u202f=\u202f221) admitted to Neonatal unit in Pediatric emergency of a tertiary care hospital in north India over 1\u202fyear']","['phenobarbitone maintenance', 'phenobarbitone', 'phenobarbitone withdrawal group', ""phenobarbitone maintenance was stopped and 'phenobarbitone""]","['duration of hospital stay, abnormal neurological status at discharge, and mortality', 'similar time to reach full enteral feeds', 'mortality', 'recurrence of neonatal seizures', 'seizure recurrence until discharge and secondary outcomes were time to reach full enteral feeds', 'incidence of seizure recurrence', 'abnormal neurological status at discharge', 'duration of hospital stay', 'rate of seizure recurrence']","[{'cui': 'C0159020', 'cui_str': 'Convulsions in the newborn'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C1299590', 'cui_str': 'Seizure free'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0031412', 'cui_str': 'Phenobarbital'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0450446', 'cui_str': 'Stops'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0746866', 'cui_str': 'Neurological status'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0159020', 'cui_str': 'Convulsions in the newborn'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",221.0,0.333646,does not lead to a significant increase in the rate of seizure recurrence.,"[{'ForeName': 'Ankush', 'Initials': 'A', 'LastName': 'Jindal', 'Affiliation': 'Department of Pediatrics, Advanced Pediatric Centre, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Suresh Kumar', 'Initials': 'SK', 'LastName': 'Angurana', 'Affiliation': 'Division of Pediatric Critical Care, Department of Pediatrics, Advanced Pediatric Centre, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India. Electronic address: sureshangurana@gmail.com.'}, {'ForeName': 'Renu', 'Initials': 'R', 'LastName': 'Suthar', 'Affiliation': 'Division of Pediatric Neurology, Department of Pediatrics, Advanced Pediatric Centre, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Advanced Pediatric Centre, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Venkataseshan', 'Initials': 'V', 'LastName': 'Sundaram', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Advanced Pediatric Centre, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2021.107875'] 2451,33715216,Integration of Well-Being Therapy and Positive Psychotherapy: A Response to Fava and Guidi's (2021) Commentary on Radstaak et al. (2020).,"The results of our study on the effects of well-being therapy (WBT) compared with a treatment-as-usual (TAU) control condition among individuals with residual symptoms of posttraumatic stress disorder (PTSD) were recently published in the Journal of Traumatic Stress (Radstaak et al., 2020). In a subsequent commentary, Fava and Guidi (2020) raised several conceptual and methodological issues that they asserted potentially limited the interpretation of the results. In this response, we aim to clarify these issues, thus contributing to the optimal interpretation of the findings.",2021,"The results of our study on the effects of well-being therapy (WBT) compared with a treatment-as-usual (TAU) control condition among individuals with residual symptoms of posttraumatic stress disorder (PTSD) were recently published in the Journal of Traumatic Stress (Radstaak et al., 2020).",['individuals with residual symptoms of posttraumatic stress disorder (PTSD'],"['Well-Being Therapy and Positive Psychotherapy', 'well-being therapy (WBT']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]",[],,0.0255048,"The results of our study on the effects of well-being therapy (WBT) compared with a treatment-as-usual (TAU) control condition among individuals with residual symptoms of posttraumatic stress disorder (PTSD) were recently published in the Journal of Traumatic Stress (Radstaak et al., 2020).","[{'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Radstaak', 'Affiliation': 'Department of Psychology, Health and Technology, University of Twente, Enschede, The Netherlands.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hüning', 'Affiliation': 'Mediant Community Mental Health Center, Enschede, The Netherlands.'}, {'ForeName': 'Ernst T', 'Initials': 'ET', 'LastName': 'Bohlmeijer', 'Affiliation': 'Department of Psychology, Health and Technology, University of Twente, Enschede, The Netherlands.'}]",Journal of traumatic stress,['10.1002/jts.22671'] 2452,33713817,"Efficacy and safety of pegylated interferon alfa-2b in moderate COVID-19: A phase II, randomized, controlled, open-label study.","OBJECTIVE To evaluate the efficacy and safety of pegylated interferon alfa-2b (PEG IFN-α2b) along with the standard of care (SOC) in subjects with moderate COVID-19. METHODS In this phase 2, randomized, open-label study, adult subjects aged ≥18 years with RT-PCR confirmed COVID-19 with moderate symptoms were randomized in a 1:1 to receive PEG IFN-α2b plus SOC, or SOC alone. The primary endpoint was improvement in clinical status on day 15, measured by the WHO 7-point ordinal scale. RESULTS Forty subjects were randomized to PEG IFN-α2b plus SOC (n = 20) and SOC (n = 20). Overall, 19 (95.00%) subjects in PEG IFN-α2b plus SOC had achieved clinical improvement on day 15 compared to 13 (68.42%) subjects in SOC (p < 0.05). Overall, 80% and 95% of subjects in the PEG IFN-α2b plus SOC group had a negative RT-PCR result on day 7 and day 14, respectively, compared to 63% and 68% in the SOC group. Adverse events (AEs) were reported for eleven subjects in the PEG IFN-α2b plus SOC group and eight subjects in the SOC group. All reported AEs were mild. CONCLUSION The significant improvement in clinical status on day 15 is likely due to faster viral reduction compared to SOC with the PEG IFN-α2b treated moderate COVID-19 subjects showing a difference as early as day seven and becoming significant by day 14.",2021,"Overall, 19 (95.00%) subjects in PEG IFN-α2b plus SOC had achieved clinical improvement on day 15 compared to 13 (68.42%) subjects in SOC (p < 0.05).","['adult subjects aged >18 years with RT-PCR confirmed COVID-19 with moderate symptoms', 'Moderate COVID-19', 'Total 40 subjects', 'subjects with moderate COVID-19']","['pegylated interferon alfa-2b (PEG IFN-α2b', 'IFN-α2b', 'PEG IFN-α2b plus SOC', 'PEG', 'PEG IFN-α2b plus SOC, or SOC alone', 'Pegylated Interferon alfa-2b']","['clinical status on day 15, measured by WHO 7-point ordinal scale', 'Efficacy and Safety', 'negative RT-PCR', 'efficacy and safety', 'Adverse events (AEs', 'clinical improvement']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0021735', 'cui_str': 'Interferon Alfa-2b'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",40.0,0.0513311,"Overall, 19 (95.00%) subjects in PEG IFN-α2b plus SOC had achieved clinical improvement on day 15 compared to 13 (68.42%) subjects in SOC (p < 0.05).","[{'ForeName': 'Anuja', 'Initials': 'A', 'LastName': 'Pandit', 'Affiliation': 'National Cancer Institute, Badsa, Jhajjar, Haryana 124105, India.'}, {'ForeName': 'Nirav', 'Initials': 'N', 'LastName': 'Bhalani', 'Affiliation': 'Rhythm Heart Institute, Near Siddharth Bungalows, Sama Savli Road, Vadodara 390022, Gujarat, India.'}, {'ForeName': 'B L Shashi', 'Initials': 'BLS', 'LastName': 'Bhushan', 'Affiliation': 'Victoria Hospital, Bangalore Medical College & Research Institute, Fort K R Road, Bangalore Urban, Karnataka 560002, India.'}, {'ForeName': 'Parshottam', 'Initials': 'P', 'LastName': 'Koradia', 'Affiliation': 'BAPS Pramukh Swami Hospital, Shri Pramukh Swami Maharaj Marg, Adajan Char Road, Adajan, Surat 395009, Gujarat, India.'}, {'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Gargiya', 'Affiliation': 'Tapan Research Centre, Basement Tapan Hospital Nr. Platinum Hall, Anandnagar Cross Road Satellite, Ahmedabad 380015, Gujarat, India.'}, {'ForeName': 'Vinay', 'Initials': 'V', 'LastName': 'Bhomia', 'Affiliation': 'Sanjivani Super Speciality Hospital, 1, Uday Park Society, Nr. Sunrise Park, Vastrapur, Ahmedabad 380015, Gujarat, India.'}, {'ForeName': 'Kevinkumar', 'Initials': 'K', 'LastName': 'Kansagra', 'Affiliation': 'Zydus Research Centre, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad 382213, Gujarat, India. Electronic address: kevinkumarkansagra@zyduscadila.com.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2021.03.015'] 2453,33706305,Clinical Effect of Two Fluoride Varnishes in Caries-Active Preschool Children: A Randomized Controlled Trial.,"The prevention of dental caries in preschool children is a priority for dental services. The aim of the study was to investigate the caries-preventive effect of 2 fluoride varnishes in caries-active preschool children, and then compare the outcome with a non-varnish control group. After screening, 180 preschool children aged 36-71 months, with at least 1 noncavitated lesion, were enrolled and randomly allocated into 3 parallel groups, namely A: 1.5% ammonium fluoride varnish (Fluor Protector S), B: 5% NaF varnish (Duraphat), and C: professional tooth-cleaning. All children were recalled every third month for intervention and their parents were instructed to have them brush their teeth with a 1,000-ppm fluoride toothpaste twice daily. Caries were recorded at baseline and after 12 months by a calibrated examiner and the incidence was scored on noncavitated (d2) and cavitated (d3) level. We tested differences between the groups with the χ2 and two-sided t tests. One hundred and seventy-two children (95.6%) completed the trial and 56 (32.6%) and 35 (19.2%) developed new d2 and d3 lesions, respectively. Both varnishes reduced the incidence of caries compared with the control group, but there was no significant difference between group A and group B. Compared with group C, the relative risk for developing cavitated lesions was 0.39 (95% CI 0.22-0.62) in group A and 0.26 (95% CI 0.14-0.50) in group B. The total prevented fraction (Δd2d3mft) for group A and group B was 19.9 and 22.5% (p < 0.05), respectively. No adverse effects were observed or reported during the study period. In conclusion, the 2 fluoride varnishes demonstrated an equal capacity to reduce the incidence of caries in caries-active preschool children over a 12-month period in comparison with a control group.",2021,"Both varnishes reduced the incidence of caries compared with the control group, but there was no significant difference between group A and group B. Compared with group C, the relative risk for developing cavitated lesions was 0.39 (95% CI 0.22-0.62) in group A and 0.26 (95% CI 0.14-0.50) in group","['preschool children', 'caries-active preschool children', '180 preschool children aged 36-71 months, with at least 1 noncavitated lesion', 'Caries-Active Preschool Children']","['fluoride varnishes', 'ammonium fluoride varnish (Fluor Protector S), B: 5% NaF varnish (Duraphat), and C: professional tooth-cleaning', 'Two Fluoride Varnishes']","['incidence of caries', 'Caries', 'adverse effects', 'caries-preventive effect', 'relative risk for developing cavitated lesions']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0429170', 'cui_str': 'Caries active'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0051717', 'cui_str': 'ammonium fluoride'}, {'cui': 'C0042359', 'cui_str': 'Varnish'}, {'cui': 'C0060511', 'cui_str': 'Fluor Protector'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",180.0,0.141125,"Both varnishes reduced the incidence of caries compared with the control group, but there was no significant difference between group A and group B. Compared with group C, the relative risk for developing cavitated lesions was 0.39 (95% CI 0.22-0.62) in group A and 0.26 (95% CI 0.14-0.50) in group","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Turska-Szybka', 'Affiliation': 'Department of Paediatric Dentistry, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Gozdowski', 'Affiliation': 'Department of Experimental Statistics and Bioinformatics, Warsaw University of Life Science, Warsaw, Poland.'}, {'ForeName': 'Svante', 'Initials': 'S', 'LastName': 'Twetman', 'Affiliation': 'Department of Odontology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Olczak-Kowalczyk', 'Affiliation': 'Department of Paediatric Dentistry, Medical University of Warsaw, Warsaw, Poland, dorota.olczak-kowalczyk@wum.edu.pl.'}]",Caries research,['10.1159/000514168'] 2454,33706084,TRS2P and LDL-C alone or in combination for predicting absolute benefits from additional LDL-C lowering: Analysis from the TNT trial.,"BACKGROUND AND AIMS Despite trial evidence, high intensity statins are underutilized in routine clinical practice. This study sought to assess the individual and joint contributions of the TRS2P score as a measure of residual risk and LDL-C levels to benefits from further LDL-C lowering in the TNT trial. METHODS A total of 9980 patients were divided into 4 groups based on TRS2P and LDL-C at baseline: median (7.2%, group 4), NNT 78 vs. 14 (p-interaction <0.0001). CONCLUSIONS Measures of residual risk as well LDL-C identify patients who remain at high risk despite statins with the combination identifying those who derive the greatest benefits from even modest additional LDL-C lowering. Attention to residual risk as well as LDL-C may further help to optimize guideline implementation.",2021,"median were associated with more events and highest when both were ≥median (groups 1-4; 21.5%, 28.1%, 36.3%, and 40.5%, respectively; p-trend <0.0001.",['9980 patients'],"['TRS2P\xa0≥', 'TRS2P and LDL-C alone or in combination', 'TRS2P and LDL-C at baseline: .05). No significant differences were found in preoperative (opioid: 58.9 ± 7.0; nonopioid: 58.2 ± 5.5, P = .724) or postoperative (opioid: 59.8 ± 6.5; nonopioid: 54.9 ± 7.1, P = .064) Patient-Reported Outcomes Measurement and Information System Pain Interference Short Form scores. No difference was found in recorded side effects between both groups at any given time point: constipation, nausea, diarrhea, upset stomach, and drowsiness (P > .05). CONCLUSIONS This study found that a multimodal nonopioid pain protocol provided equivalent pain control and patient outcomes following primary meniscus surgery while having an equivalent side effect profile. All patients reported satisfaction with their pain management without requiring emergency opioid analgesia. LEVEL OF EVIDENCE Level I, prospective randomized controlled trial.",2021,"No difference was found in recorded side effects between both groups at any given time point: constipation, nausea, diarrhea, upset stomach, and drowsiness (p > 0.05). ","['A total of 61 patients', 'All patients reported satisfaction with their pain management without requiring emergency opioid analgesia', 'primary meniscectomy or meniscal repair', ' Ninety-nine patients undergoing primary meniscectomy or meniscal repair were assessed for participation']","['Multimodal Nonopioid Pain Protocol Provides Equivalent Pain Versus Opioid Control', 'multimodal nonopioid pain protocol', 'multimodal non-opioid analgesic protocol and a standard opioid regimen', 'nonopioid', 'nonopioid pain regimen', 'Meniscus Surgery']","['recorded side effects', 'equivalent pain control and patient outcomes', 'constipation, nausea, diarrhea, upset stomach, and drowsiness', 'patient reported outcomes, complications and patient satisfaction', 'postoperative pain level (visual analog scale', 'non-inferior VAS scores']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0187901', 'cui_str': 'Chondrectomy of semilunar cartilage of knee'}, {'cui': 'C0407887', 'cui_str': 'Repair of meniscus'}, {'cui': 'C3828813', 'cui_str': '99'}]","[{'cui': 'C0242937', 'cui_str': 'Non-opioid analgesic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0224498', 'cui_str': 'Meniscus structure of joint'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0235309', 'cui_str': 'Upset stomach'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",61.0,0.313949,"No difference was found in recorded side effects between both groups at any given time point: constipation, nausea, diarrhea, upset stomach, and drowsiness (p > 0.05). ","[{'ForeName': 'Toufic R', 'Initials': 'TR', 'LastName': 'Jildeh', 'Affiliation': 'Department of Orthopaedic Surgery, Henry Ford Hospital, Detroit, Michigan, U.S.A.. Electronic address: touficjildeh@gmail.com.'}, {'ForeName': 'Kelechi R', 'Initials': 'KR', 'LastName': 'Okoroha', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic, Minneapolis, Minnesota, U.S.A.'}, {'ForeName': 'Noah', 'Initials': 'N', 'LastName': 'Kuhlmann', 'Affiliation': 'Department of Orthopaedic Surgery, Henry Ford Hospital, Detroit, Michigan, U.S.A.'}, {'ForeName': 'Austin', 'Initials': 'A', 'LastName': 'Cross', 'Affiliation': 'Department of Orthopaedic Surgery, Henry Ford Hospital, Detroit, Michigan, U.S.A.'}, {'ForeName': 'Muhammad J', 'Initials': 'MJ', 'LastName': 'Abbas', 'Affiliation': 'Department of Orthopaedic Surgery, Henry Ford Hospital, Detroit, Michigan, U.S.A.'}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Moutzouros', 'Affiliation': 'Department of Orthopaedic Surgery, Henry Ford Hospital, Detroit, Michigan, U.S.A.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2021.02.043'] 2461,33716121,"Safety and Efficacy of an Amniotic Suspension Allograft Injection Over 12 Months in a Single-Blinded, Randomized Controlled Trial for Symptomatic Osteoarthritis of the Knee.","PURPOSE The purpose of this study is to determine the efficacy of amniotic suspension allograft (ASA) compared to hyaluronic acid (HA) and saline at up to 12 months of follow-up through the use of patient-reported outcomes, immunoglobulin levels, and anti-human leukocyte antigen (HLA) levels. METHODS Within this multicenter study, 200 patients were randomized 1:1:1 to a single intra-articular injection of saline, HA, or ASA. Patient-reported outcomes, including Knee Injury and Osteoarthritis Outcome Score (KOOS) and visual analog scale (VAS) score, were collected at multiple time points (baseline, 1 week, 6 weeks, 3 months, 6 months) out to 12 months to assess improvements in pain and function. Radiographs at baseline and 12 months were taken to determine radiographic changes, while blood was collected at baseline, 6 weeks, and 6 months to determine changes in immunoglobulins and anti-HLA levels. Statistical analyses were performed using last observation carried forward and mixed effects model for repeated measures. RESULTS Treatment with ASA resulted in significant improvements in KOOS and VAS scores that were maintained through 12 months (P < .05). Treatment with ASA resulted in a 63.2% responder rate at 12 months using the Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International simplified definition. There were no significant differences between groups for radiographic measures in the index knee, immunoglobulins, C-reactive protein, or anti-HLA serum levels (P > .05). The number and type of adverse events (AEs) reported for ASA were comparable to the HA injection group, while no treatment-emergent AEs were reported for the saline group. CONCLUSIONS This randomized controlled trial of ASA vs HA and saline for the treatment of symptomatic knee osteoarthritis demonstrated clinically meaningful improved outcomes with ASA over the controls out to 12 months postinjection. No concerning immunologic or adverse reactions to the ASA injection were identified with regards to severe AEs, immunoglobulin, or anti-HLA levels. LEVEL OF EVIDENCE Level I, randomized controlled multicenter trial.",2021,"There were no significant differences between groups for radiographic measures in the index knee, immunoglobulins, C-reactive protein (CRP), or anti-HLA serum levels (p>0.05).","['200 patients', 'Symptomatic Osteoarthritis of the Knee']","['single intra-articular injection of saline, HA, or ASA', 'ASA versus HA and saline', 'ASA', 'hyaluronic acid (HA) and saline', 'amniotic suspension allograft (ASA', 'Amniotic Suspension Allograft Injection']","['pain and function', 'KOOS and VAS scores', 'Patient-reported outcomes (PROs), including Knee Injury and Osteoarthritis Outcome Score (KOOS) and Visual Analog Score (VAS', 'severe adverse events, immunoglobulin or anti-HLA levels', 'Safety and Efficacy', 'immunoglobulins and anti-HLA levels', 'number and type of adverse events (AEs', 'index knee, immunoglobulins, C-reactive protein (CRP), or anti-HLA serum levels', 'immunoglobulin levels, and anti-HLA levels']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021488', 'cui_str': 'Intra-articular injection'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0002630', 'cui_str': 'Structure of amnion'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0019630', 'cui_str': 'Class II Histocompatibility Antigens'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0428536', 'cui_str': 'Immunoglobulin level - finding'}]",200.0,0.343022,"There were no significant differences between groups for radiographic measures in the index knee, immunoglobulins, C-reactive protein (CRP), or anti-HLA serum levels (p>0.05).","[{'ForeName': 'Andreas H', 'Initials': 'AH', 'LastName': 'Gomoll', 'Affiliation': 'Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, New York, U.S.A.. Electronic address: gomolla@hss.edu.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Farr', 'Affiliation': 'Knee Preservation and Cartilage Restoration Center, OrthoIndy, Indianapolis, Indiana, U.S.A.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Cole', 'Affiliation': 'Midwest Orthopaedics at Rush, Rush University Medical Center, Chicago, Illinois, U.S.A.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Flanigan', 'Affiliation': 'Division of Sports Medicine Cartilage Repair Center, Department of Orthopaedics, The Ohio State University, Columbus, Ohio, U.S.A.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lattermann', 'Affiliation': ""Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, Massachusetts, U.S.A.""}, {'ForeName': 'Bert R', 'Initials': 'BR', 'LastName': 'Mandelbaum', 'Affiliation': 'Cedars-Sinai Kerlan-Jobe Institute, Santa Monica, California, U.S.A.'}, {'ForeName': 'Sabrina M', 'Initials': 'SM', 'LastName': 'Strickland', 'Affiliation': 'Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, New York, U.S.A.'}, {'ForeName': 'Kenneth R', 'Initials': 'KR', 'LastName': 'Zaslav', 'Affiliation': 'OrthoVirginia, Richmond, Virginia.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Kimmerling', 'Affiliation': 'Department of Research and Development, Organogenesis, Birmingham, Alabama, U.S.A.'}, {'ForeName': 'Katie C', 'Initials': 'KC', 'LastName': 'Mowry', 'Affiliation': 'Department of Research and Development, Organogenesis, Birmingham, Alabama, U.S.A.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2021.02.044'] 2462,33716071,Effect of sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral ligament suspension on treatment failure in women with uterovaginal prolapse: 5-year results of a randomized clinical trial.,"BACKGROUND Vaginal hysterectomy with suture apical suspension is commonly performed for uterovaginal prolapse. Sacrospinous hysteropexy with graft (vaginal mesh hysteropexy) is an alternative, although in 2019 the Food and Drug Administration removed this mesh product from the United States market. OBJECTIVE Our objective was to compare the efficacy and adverse events of these 2 procedures. STUDY DESIGN At 9 clinical sites in the United States National Institutes of Health and National Institute of Child Health and Human Development Pelvic Floor Disorders Network, 183 postmenopausal women requesting vaginal surgery for symptomatic uterovaginal prolapse were enrolled in a multisite randomized superiority clinical trial, comparing a sacrospinous hysteropexy with graft (hysteropexy) with a vaginal hysterectomy with uterosacral ligament suspension (hysterectomy). Participants consented to remain masked to treatment assignment for the study duration. Study visits were conducted at 6-month intervals through 60 months. The primary treatment failure composite outcome (retreatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) was evaluated with survival modeling. Secondary outcomes included complications or adverse events, individual anatomic measures of the pelvic organ prolapse quantification examination, and presence, severity, and impact and bother of prolapse, urinary, bowel, and pain symptoms as measured by validated questionnaires. The 3-year published results suggested better primary outcomes with sacrospinous hysteropexy with graft, but the differences were not statistically significant (P=.06). This study reports the 5-year outcomes. RESULTS A total of 183 women with a mean age of 66 years were randomized between April 2013 and February 2015; 93 were randomized to hysteropexy and 90 were randomized to hysterectomy. Notably, 175 were included in the trial, and 156 (89%) completed the 5-year follow-up. The primary outcome showed fewer failures for hysteropexy than hysterectomy through 5 years (adjusted hazard ratio, 0.58; 95% confidence interval, 0.36-0.94; P=.03), with failure rates of 37% vs 54%, respectively, resulting in a difference of -18% (95% confidence interval, -33% to -3%) at 5 years. With the exception of the Urogenital Distress Inventory, no group differences were demonstrated in patient-reported pelvic floor symptoms, prolapse symptoms, bowel function symptoms, general quality of life, body image, or pelvic pain. At their last visit through 5 years, 70% of participants (129 of 183) reported they remained masked to their treatment with no difference in masking between groups. Adverse events for hysteropexy vs hysterectomy included mesh exposure (8% vs 0%), granulation tissue after 12 weeks (1% vs 12%), and suture exposure after 12 weeks (3% vs 21%), respectively. CONCLUSION Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery, sacrospinous hysteropexy with graft resulted in a lower composite failure rate than vaginal hysterectomy through 5 years. There were no meaningful differences in patient-reported outcomes between groups. Our results suggest that this vaginal mesh hysteropexy procedure should be made available to patients.",2021,"With the exception of the Urogenital Distress Inventory, no group differences were demonstrated in patient reported pelvic floor symptoms, prolapse symptoms, bowel function symptoms, general quality of life, body image, or pelvic pain.","['One hundred and eighty three women with a mean age of 66 years were randomized between April 2013 and February 2015, 93 were randomized to hysteropexy and 90 were randomized hysterectomy', '183 postmenopausal women requesting vaginal surgery for symptomatic uterovaginal prolapse', 'women with symptomatic uterovaginal prolapse undergoing vaginal surgery', 'women with uterovaginal prolapse', 'One hundred seventy-five (175) were included in the trial, and 156 (89%) completed the 5 year follow-up']","['Vaginal hysterectomy with suture apical suspension', 'vaginal hysterectomy with uterosacral ligament suspension (hysterectomy', 'Sacrospinous hysteropexy with graft (vaginal mesh hysteropexy', 'sacrospinous hysteropexy with graft (hysteropexy', 'sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral ligament suspension']","['composite failure rate', 'Adverse events', 'efficacy and adverse events', 'failure composite outcome (retreatment of prolapse, prolapse beyond the hymen, or prolapse symptoms', 'complications or adverse events, individual anatomic measures of the POP-Q examination, and presence, severity and impact/bother of prolapse, urinary, bowel, and pain symptoms as measured by validated questionnaires', 'failures for hysteropexy', 'failure rates', 'pelvic floor symptoms, prolapse symptoms, bowel function symptoms, general quality of life, body image, or pelvic pain', 'granulation tissue']","[{'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0195386', 'cui_str': 'Uteropexy'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0195117', 'cui_str': 'Operation on vagina'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0156353', 'cui_str': 'Uterovaginal prolapse'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0020700', 'cui_str': 'Vaginal hysterectomy'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0230306', 'cui_str': 'Structure of uterosacral ligament'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0195386', 'cui_str': 'Uteropexy'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0195386', 'cui_str': 'Uteropexy'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0018180', 'cui_str': 'Granulation tissue'}]",183.0,0.359576,"With the exception of the Urogenital Distress Inventory, no group differences were demonstrated in patient reported pelvic floor symptoms, prolapse symptoms, bowel function symptoms, general quality of life, body image, or pelvic pain.","[{'ForeName': 'Charles W', 'Initials': 'CW', 'LastName': 'Nager', 'Affiliation': 'Obstetrics, Gynecology, and Reproductive Sciences, University of California San Diego Health, San Diego, CA. Electronic address: cnager@health.ucsd.edu.'}, {'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Visco', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Richter', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Alabama At Birmingham, Birmingham, AL.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Rardin', 'Affiliation': 'Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Komesu', 'Affiliation': 'Department of Obstetrics and Gynecology, University of New Mexico, Albuquerque, NM.'}, {'ForeName': 'Heidi S', 'Initials': 'HS', 'LastName': 'Harvie', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Halina M', 'Initials': 'HM', 'LastName': 'Zyczynski', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, Magee-Womens Research Institute, Pittsburgh, PA.'}, {'ForeName': 'Marie Fidela R', 'Initials': 'MFR', 'LastName': 'Paraiso', 'Affiliation': 'Department of Obstetrics and Gynecology, Cleveland Clinic Foundation, Cleveland, OH.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Mazloomdoost', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Amaanti', 'Initials': 'A', 'LastName': 'Sridhar', 'Affiliation': 'Biostatistics and Epidemiology Division, RTI International, Research Triangle Park, NC.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': 'Biostatistics and Epidemiology Division, RTI International, Research Triangle Park, NC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2021.03.012'] 2463,33719448,Application of Comparative Lipidomics to Elucidate Postprandial Metabolic Excursions Following Dairy Milk Ingestion in Individuals with Prediabetes.,"Nutrient-dense dairy foods are an important component of a healthy diet. Recommendations, however, advise non- and low-fat dairy foods despite controversy concerning whether full-fat dairy foods adversely impact cardiometabolic health. Therefore, in this study, our objective is to examine the differential plasma lipidomic responses to non-fat or full-fat milk ingestion during postprandial hyperglycemia. Seven adults with prediabetes completed a randomized cross-over study in which glucose was consumed alone or with non-fat or full-fat dairy milk. Plasma samples collected at 90 min and 180 min post milk ingestion were used to perform untargeted lipidomics analysis. A total of 332 lipids from 20 classes and five lipid categories were detected at different time points during the postprandial period. Dairy milk, especially non-fat milk, protected against lipid changes otherwise induced by glucose ingestion. Co-ingestion of dairy milk with glucose, regardless of fat content, significantly altered lipid profiles although full-fat milk more substantially modulated lipid profiles. For the identified lipid biomarkers, 68.0% and 66.7% of the lipids significantly increased at 90 and 180 min, respectively, while phosphatidylcholines (GPs) contributed most for the significant increase. Comparative lipidomics analysis indicated that both types of dairy milk induced significant changes in several lipid pathways, including glycerophospholipid metabolism and α-linolenic acid metabolism, to protect against postprandial hyperglycemia. In summary, our comparative lipidomics results suggested that dairy milk-mediated lipid modulation may be an effective dietary approach to reduce the risk of metabolic diseases among those with prediabetes.",2021,"Co-ingestion of dairy milk with glucose, regardless of fat content, significantly altered lipid profiles although full-fat milk more substantially modulated lipid profiles.","['Seven adults with prediabetes', 'Individuals with Prediabetes']","['Dairy Milk Ingestion', 'glucose was consumed alone or with non-fat or full-fat dairy milk']","['several lipid pathways, including glycerophospholipid metabolism and α-linolenic acid metabolism', 'Postprandial Metabolic Excursions']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0162448', 'cui_str': 'Phosphoglycerides'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0051405', 'cui_str': 'alpha-Linolenic Acid'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}]",7.0,0.00834522,"Co-ingestion of dairy milk with glucose, regardless of fat content, significantly altered lipid profiles although full-fat milk more substantially modulated lipid profiles.","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Human Nutrition Program, Department of Human Sciences, The Ohio State University, Columbus, Ohio 43210, United States.'}, {'ForeName': 'Shiqi', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Human Nutrition Program, Department of Human Sciences, The Ohio State University, Columbus, Ohio 43210, United States.'}, {'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Human Nutrition Program, Department of Human Sciences, The Ohio State University, Columbus, Ohio 43210, United States.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'McDonald', 'Affiliation': 'Human Nutrition Program, Department of Human Sciences, The Ohio State University, Columbus, Ohio 43210, United States.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Bruno', 'Affiliation': 'Human Nutrition Program, Department of Human Sciences, The Ohio State University, Columbus, Ohio 43210, United States.'}, {'ForeName': 'Jiangjiang', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Human Nutrition Program, Department of Human Sciences, The Ohio State University, Columbus, Ohio 43210, United States.'}]",Journal of proteome research,['10.1021/acs.jproteome.0c01009'] 2464,33691760,Feasibility and efficacy of a decision aid for emergency department patients with suspected ureterolithiasis: protocol for an adaptive randomized controlled trial.,"BACKGROUND Approximately 2 million patients present to emergency departments in the USA annually with signs and symptoms of ureterolithiasis (or renal colic, the pain from an obstructing kidney stone). Both ultrasound and CT scan can be used for diagnosis, but the vast majority of patients receive a CT scan. Diagnostic pathways utilizing ultrasound have been shown to decrease radiation exposure to patients but are potentially less accurate. Because of these and other trade-offs, this decision has been proposed as appropriate for Shared Decision-Making (SDM), where clinicians and patients discuss clinical options and their consequences and arrive at a decision together. We developed a decision aid to facilitate SDM in this scenario. The objective of this study is to determine the effects of this decision aid, as compared to usual care, on patient knowledge, radiation exposure, engagement, safety, and healthcare utilization. METHODS This is the protocol for an adaptive randomized controlled trial to determine the effects of the intervention-a decision aid (""Kidney Stone Choice"")-on patient-centered outcomes, compared with usual care. Patients age 18-55 presenting to the emergency department with signs and symptoms consistent with acute uncomplicated ureterolithiasis will be consecutively enrolled and randomized. Participants will be blinded to group allocation. We will collect outcomes related to patient knowledge, radiation exposure, trust in physician, safety, and downstream healthcare utilization. DISCUSSION We hypothesize that this study will demonstrate that ""Kidney Stone Choice,"" the decision aid created for this scenario, improves patient knowledge and decreases exposure to ionizing radiation. The adaptive design of this study will allow us to identify issues with fidelity and feasibility and subsequently evaluate the intervention for efficacy. TRIAL REGISTRATION ClinicalTrials.gov NCT04234035 . Registered on 21 January 2020 - Retrospectively Registered.",2021,Patients age 18-55 presenting to the emergency department with signs and symptoms consistent with acute uncomplicated ureterolithiasis will be consecutively enrolled and randomized.,"['Patients age 18-55 presenting to the emergency department with signs and symptoms consistent with acute uncomplicated ureterolithiasis', 'emergency department patients with suspected ureterolithiasis', 'Registered on 21 January 2020 - Retrospectively Registered', 'Approximately 2 million patients present to emergency departments in the USA annually with signs and symptoms of ureterolithiasis (or renal colic, the pain from an obstructing kidney stone']",['ultrasound and CT scan'],['Feasibility and efficacy'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0152169', 'cui_str': 'Renal colic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0549186', 'cui_str': 'Obstructed'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.20566,Patients age 18-55 presenting to the emergency department with signs and symptoms consistent with acute uncomplicated ureterolithiasis will be consecutively enrolled and randomized.,"[{'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Schoenfeld', 'Affiliation': 'Department of Emergency Medicine and Institute for Healthcare Delivery and Population Science, University of Massachusetts Medical School - Baystate, Springfield, MA, USA. ElizSchoen@gmail.com.'}, {'ForeName': 'Kye E', 'Initials': 'KE', 'LastName': 'Poronsky', 'Affiliation': 'Department of Emergency Medicine and Institute for Healthcare Delivery and Population Science, University of Massachusetts Medical School - Baystate, Springfield, MA, USA.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Westafer', 'Affiliation': 'Department of Emergency Medicine and Institute for Healthcare Delivery and Population Science, University of Massachusetts Medical School - Baystate, Springfield, MA, USA.'}, {'ForeName': 'Brianna M', 'Initials': 'BM', 'LastName': 'DiFronzo', 'Affiliation': 'Department of Emergency Medicine and Institute for Healthcare Delivery and Population Science, University of Massachusetts Medical School - Baystate, Springfield, MA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Visintainer', 'Affiliation': 'Department of Medicine, and Institute for Healthcare Delivery and Population Science Epidemiology and Biostatistics Research Core, University of Massachusetts Medical School - Baystate, Springfield, MA, USA.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Scales', 'Affiliation': 'Duke Clinical Research Institute and Division of Urologic Surgery, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Erik P', 'Initials': 'EP', 'LastName': 'Hess', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, TN, Memphis, USA.'}, {'ForeName': 'Peter K', 'Initials': 'PK', 'LastName': 'Lindenauer', 'Affiliation': 'Institute for Healthcare Delivery and Population Science, University of Massachusetts Medical School - Baystate, Springfield, MA, USA.'}]",Trials,['10.1186/s13063-021-05140-9'] 2465,33711136,Randomized clinical trial on closure versus non-closure of mesenteric defects during laparoscopic gastric bypass surgery.,"BACKGROUND Internal herniation is a well known and potentially life-threatening complication of laparoscopic Roux-en-Y gastric bypass (LRYGB). The aim of this study was to evaluate the benefit and harm of closing the mesenteric defects with clips during LRYGB to prevent internal herniation. METHODS This was a single-centre, single-blinded RCT. Patients eligible for LRYGB were randomized to surgery with or without closure of mesenteric defects with clips. The primary endpoint was the incidence of (intermittent) internal herniation after LRYGB with a minimum follow-up of 24 months. Secondary outcomes were duration of surgery, number of clips used, trocars and sutures used, postoperative pain measured by a visual analogue scale (VAS), and postoperative complications. RESULTS Between 13 August 2012 and 18 May 2017, 401 patients were randomized to closure (201) or non-closure (200) of mesenteric defects. Median follow-up for both groups was 59 months (range 8-67 and 16-67 months in non-closure and closure groups respectively). The cumulated risk of internal herniation after 2 years was 8.0 per cent in the non-closure group compared with 4.5 per cent in the closure group (hazard ratio (HR) 1.81, 95 per cent c.i. 0.80 to 4.12; P = 0.231). At 5 years, rates were 15.5 and 6.5 per cent respectively (HR 2.52, 1.32 to 4.81; P = 0.005). Closure of mesenteric defects increased operating time by a median of 4 min (95 per cent c.i. 52 to 56 min for the non-closure group and 56 to 60 min for the closure group; P = 0.002). There was no difference in postoperative blood transfusion rates and VAS scores between the groups. CONCLUSION Routine closure of the mesenteric defects in LRYGB with clips is associated with a lower rate of internal herniation. Registration number: NCT01595230 (http://www.clinicaltrials.gov).",2021,"The cumulated risk of internal herniation after 2 years was 8.0 per cent in the non-closure group compared with 4.5 per cent in the closure group (hazard ratio (HR) 1.81, 95 per cent c.i.","['Between 13 August 2012 and 18 May 2017, 401 patients were randomized to closure (201) or non-closure (200) of mesenteric defects', 'Patients eligible for LRYGB']","['surgery with or without closure of mesenteric defects with clips', 'closure versus non-closure', 'laparoscopic gastric bypass surgery']","['postoperative blood transfusion rates and VAS scores', 'incidence of (intermittent) internal herniation', 'duration of surgery, number of clips used, trocars and sutures used, postoperative pain measured by a visual analogue scale (VAS), and postoperative complications', 'cumulated risk of internal herniation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0025474', 'cui_str': 'Mesenteric'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0025474', 'cui_str': 'Mesenteric'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C4039248', 'cui_str': 'Laparoscopic bypass of stomach'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0041158', 'cui_str': 'Trocar'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",401.0,0.218519,"The cumulated risk of internal herniation after 2 years was 8.0 per cent in the non-closure group compared with 4.5 per cent in the closure group (hazard ratio (HR) 1.81, 95 per cent c.i.","[{'ForeName': 'S D', 'Initials': 'SD', 'LastName': 'Kristensen', 'Affiliation': 'Department of Surgery, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gormsen', 'Affiliation': 'Department of Surgery, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Naver', 'Affiliation': 'Department of Surgery, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Helgstrand', 'Affiliation': 'Department of Surgery, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Floyd', 'Affiliation': 'Department of Surgery, Hospital South West Jutland, University Hospital Southern Denmark, Esbjerg, Denmark.'}]",The British journal of surgery,['10.1093/bjs/znaa055'] 2466,33711134,"Author response to: Comment on: ""Randomized clinical trial of negative pressure wound therapy as an adjunctive treatment for small-area thermal burns in children"" by Frear et al.",,2021,,"['small-area thermal burns in children"" by Frear et al']",['negative pressure wound therapy'],[],"[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0701836', 'cui_str': 'Thermal burn'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}]",[],,0.115268,,"[{'ForeName': 'Cody C', 'Initials': 'CC', 'LastName': 'Frear', 'Affiliation': ""Centre for Children's Burns and Trauma Research, Centre for Children's Health Research, South Brisbane, Australia.""}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Cuttle', 'Affiliation': ""Centre for Children's Burns and Trauma Research, Centre for Children's Health Research, South Brisbane, Australia.""}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'McPhail', 'Affiliation': 'Australian Centre for Health Services Innovation and Centre for Healthcare Transformation, School of Public Health and Social Work, Faculty of Health, Brisbane, Australia.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Chatfield', 'Affiliation': 'Faculty of Medicine, University of Queensland, Herston, Australia.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Kimble', 'Affiliation': ""Centre for Children's Burns and Trauma Research, Centre for Children's Health Research, South Brisbane, Australia.""}, {'ForeName': 'Bronwyn R', 'Initials': 'BR', 'LastName': 'Griffin', 'Affiliation': ""Centre for Children's Burns and Trauma Research, Centre for Children's Health Research, South Brisbane, Australia.""}]",The British journal of surgery,['10.1093/bjs/znaa078'] 2467,33711130,Correspondence: Comment on 'Randomized clinical trial of negative pressure wound therapy as an adjunctive treatment for small-area thermal burns in children' by Frear et al.,,2021,,"[""small-area thermal burns in children' by Frear et al""]",['negative pressure wound therapy'],[],"[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0701836', 'cui_str': 'Thermal burn'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}]",[],,0.154332,,"[{'ForeName': 'Pawan', 'Initials': 'P', 'LastName': 'Agarwal', 'Affiliation': 'Department of Surgery, NSCB Government Medical College, Jabalpur, India.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Sharma', 'Affiliation': 'Department of Surgery, NSCB Government Medical College, Jabalpur, India.'}]",The British journal of surgery,['10.1093/bjs/znaa077'] 2468,33711115,Comment on: Use of an intraoperative wound protector to prevent surgical-site infection after pancreatoduodenectomy: randomized clinical trial.,,2021,,[],['intraoperative wound protector'],[],[],"[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0021501', 'cui_str': 'wounds'}]",[],,0.364775,,"[{'ForeName': 'Chong-Chi', 'Initials': 'CC', 'LastName': 'Chiu', 'Affiliation': 'Department of General Surgery, E-Da Cancer Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Po-Huang', 'Initials': 'PH', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, E-Da Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Hui-Ming', 'Initials': 'HM', 'LastName': 'Lee', 'Affiliation': 'Department of General Surgery, E-Da Cancer Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Chao-Ming', 'Initials': 'CM', 'LastName': 'Hung', 'Affiliation': 'Department of General Surgery, E-Da Cancer Hospital, Kaohsiung, Taiwan.'}]",The British journal of surgery,['10.1093/bjs/znaa084'] 2469,33711113,Response to comments on 'Use of an intraoperative wound protector to prevent surgical-site infection after pancreatoduodenectomy: randomized clinical trial'.,,2021,,[],['intraoperative wound protector'],[],[],"[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0021501', 'cui_str': 'wounds'}]",[],,0.280515,,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'De Pastena', 'Affiliation': 'Department of General and Pancreatic Surgery, Pancreas Institute, University and Hospital Trust of Verona, Verona, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Marchegiani', 'Affiliation': 'Department of General and Pancreatic Surgery, Pancreas Institute, University and Hospital Trust of Verona, Verona, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Paiella', 'Affiliation': 'Department of General and Pancreatic Surgery, Pancreas Institute, University and Hospital Trust of Verona, Verona, Italy.'}]",The British journal of surgery,['10.1093/bjs/znaa085'] 2470,33711112,Author response to: Prevention of biliary fistula after partial hepatectomy by transcystic biliary drainage: randomized clinical trial.,,2021,,['biliary fistula after partial hepatectomy by transcystic biliary drainage'],[],[],"[{'cui': 'C0005417', 'cui_str': 'Fistula of bile duct'}, {'cui': 'C0193398', 'cui_str': 'Partial hepatectomy'}, {'cui': 'C0400745', 'cui_str': 'Biliary drainage'}]",[],[],,0.229218,,"[{'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Muscari', 'Affiliation': 'Department of Digestive Surgery and Liver Transplantation, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Maulat', 'Affiliation': 'Department of Digestive Surgery and Liver Transplantation, Toulouse University Hospital, Toulouse, France.'}]",The British journal of surgery,['10.1093/bjs/znaa100'] 2471,33711111,What comes next after the surgical randomized clinical trial?,,2021,,[],[],[],[],[],[],,0.498815,,"[{'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Markar', 'Affiliation': 'Department Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Penna', 'Affiliation': 'Department Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gisbertz', 'Affiliation': 'Department of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Centre Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'G B', 'Initials': 'GB', 'LastName': 'Hanna', 'Affiliation': 'Department Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'M I', 'Initials': 'MI', 'LastName': 'van Berge Henegouwen', 'Affiliation': 'Department of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Centre Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Cuesta', 'Affiliation': 'Department of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Centre Amsterdam, Amsterdam, the Netherlands.'}]",The British journal of surgery,['10.1093/bjs/znaa069'] 2472,33714906,The effect of the group-based Otago exercise program on frailty among nursing home older adults with cognitive impairment.,"This study investigated the effect of the group-based Otago exercise program (OEP) on frailty and physical function in older adults with cognitive impairment. We recruited eighteen older adults with cognitive impairment from a nursing-home to perform the OEP three times a week, for a period of three months in a nursing home. The intervention was feasible with attending an average of 21 out of 36 sessions. The frailty score decreased significantly (p<0.05). Physical function including Time Up and Go test (TUG), 30 seconds Sit-To-Stand Test (30 s-SST) and Four-Stage Balance Test was significantly positive after intervention (all p<0.001). The group-based OEP is a potentially effective strategy for reversing frailty and improving physical function among older adults with cognitive impairment.",2021,The group-based OEP is a potentially effective strategy for reversing frailty and improving physical function among older adults with cognitive impairment.,"['older adults with cognitive impairment', 'eighteen older adults with cognitive impairment from a nursing-home to perform the OEP three times a week, for a period of three months in a nursing home', 'nursing home older adults with cognitive impairment']","['group-based Otago exercise program (OEP', 'Otago exercise program']","['frailty score', 'Physical function including Time Up and Go test (TUG), 30 seconds Sit-To-Stand Test (30\xa0s-SST) and Four-Stage Balance Test', 'frailty and physical function']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",18.0,0.0102835,The group-based OEP is a potentially effective strategy for reversing frailty and improving physical function among older adults with cognitive impairment.,"[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Feng', 'Affiliation': 'School of Health Sciences, Wuhan University, Wuhan, China.'}, {'ForeName': 'Zhijie', 'Initials': 'Z', 'LastName': 'Zou', 'Affiliation': 'School of Health Sciences, Wuhan University, Wuhan, China. Electronic address: zouzhijiehope@163.com.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'School of Health Sciences, Wuhan University, Wuhan, China. Electronic address: whzhqing@163.com.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'The First Affiliated Hospital of XiaMen University, Fujian, China.'}, {'ForeName': 'Yan-Qiong', 'Initials': 'YQ', 'LastName': 'Ouyang', 'Affiliation': 'School of Health Sciences, Wuhan University, Wuhan, China.'}, {'ForeName': 'Zhongwan', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'School of Health Sciences, Wuhan University, Wuhan, China.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Ni', 'Affiliation': 'School of Medicine, Yale University, New Haven, CT, USA.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2021.02.012'] 2473,33714860,S-1 and oxaliplatin versus tegafur-uracil and leucovorin as post-operative adjuvant chemotherapy in patients with high-risk stage III colon cancer: updated 5-year survival of the phase III ACTS-CC 02 trial.,"BACKGROUND The ACTS-CC 02 trial demonstrated that S-1 plus oxaliplatin (SOX) was not superior to tegafur-uracil and leucovorin (UFT/LV) in terms of disease-free survival (DFS) as adjuvant chemotherapy for high-risk stage III colon cancer (any T, N2, or positive nodes around the origin of the feeding arteries). We now report the final overall survival (OS) and subgroup analysis according to the pathological stage (TNM 7th edition) for treatment efficacy. PATIENTS AND METHODS Patients who underwent curative resection for pathologically confirmed high-risk stage III colon cancer were randomly assigned to receive either UFT/LV (300 mg/m 2 of UFT and 75 mg/day of LV on days 1-28, every 35 days, five cycles) or SOX (100 mg/m 2 of oxaliplatin on day 1 and 80 mg/m 2 /day of S-1 on days 1-14, every 21 days, eight cycles). The primary endpoint was DFS and the patients' data were updated in February 2020. RESULTS A total of 478 patients in the UFT/LV group and 477 patients in the SOX group were included in the final analysis. With a median follow-up time of 74.3 months, the 5-year DFS rate was 55.2% in the UFT/LV group and 58.1% in the SOX group [stratified hazard ratio (HR) 0.92; 95% confidence interval (CI) 0.76-1.11; P = 0.3973], and the 5-year OS rates were 78.3% and 79.1%, respectively (stratified HR 0.97; 95% CI 0.76-1.24; P = 0.8175). In the subgroup analysis, the 5-year OS rates in patients with T4N2b disease were 51.0% and 64.1% in the UFT/LV and SOX groups, respectively (HR 0.72; 95% CI 0.40-1.31). CONCLUSION Our final analysis reconfirmed that SOX as adjuvant chemotherapy is not superior to UFT/LV in terms of DFS in patients with high-risk stage III colon cancer. The 5-year OS rate was similar in the UFT/LV and SOX groups.",2021,(stratified HR 0.97; 95% CI 0.76-1.24; P = 0.8175).,"['Patients who underwent curative resection for pathologically confirmed high-risk stage III colon cancer', '478 patients in the UFT/LV group and 477 patients in the SOX group were included in the final analysis', 'patients with high-risk stage III colon cancer']","['S-1 plus oxaliplatin (SOX', 'UFT/LV', 'SOX', 'oxaliplatin', 'UFT and 75 mg/day of LV', 'S-1 and oxaliplatin versus tegafur-uracil and leucovorin', 'tegafur-uracil and leucovorin (UFT/LV']","['5-year DFS rate', '5-year OS rates', '5-year survival', '5-year OS rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0278480', 'cui_str': 'Carcinoma of colon, stage III'}, {'cui': 'C1446539', 'cui_str': 'Tegafur- and uracil-containing product'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C1446539', 'cui_str': 'Tegafur- and uracil-containing product'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.442925,(stratified HR 0.97; 95% CI 0.76-1.24; P = 0.8175).,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Watanabe', 'Affiliation': 'Gastroenterological Center, Yokohama City University Medical Center, Kanagawa, Japan. Electronic address: nabe-jun@comet.ocn.ne.jp.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sasaki', 'Affiliation': 'Department of Surgical Oncology, Japanese Red Cross Medical Center, Tokyo, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Kusumoto', 'Affiliation': 'Department of Gastrointestinal Surgery and Clinical Research Institute Cancer Research Division, National Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Gastroenterological Surgery, Hirosaki University Graduate School of Medicine, Aomori, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': 'Department of Surgical Oncology, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Tomita', 'Affiliation': 'Division of Lower GI Surgery, Department of Surgery, Hyogo College of Medicine, Hyogo, Japan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Maeda', 'Affiliation': 'Department of Surgery, Ogaki Municipal Hospital, Gifu, Japan.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Teshima', 'Affiliation': 'Department of Gastrointestinal Surgery, Iwate Prefectural Central Hospital, Iwate, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Yokota', 'Affiliation': 'Department of General Surgery, Kurashiki Central Hospital, Okayama, Japan.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Tanaka', 'Affiliation': 'Department of Surgery, Gifu Prefectural General Medical Center, Gifu, Japan.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Yamauchi', 'Affiliation': 'Department of Surgery, Sendai Kousei Hospital, Miyagi, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Uetake', 'Affiliation': 'Department of Specialized Surgeries, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Itabashi', 'Affiliation': ""Department of Surgery, Institute of Gastroenterology, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Baba', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kotake', 'Affiliation': 'Department of Surgery, Sano City Hospital, Tochigi, Japan.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Boku', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Aiba', 'Affiliation': 'Division of Clinical Oncology/Hematology, Department of Internal Medicine, The Tokyo Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Takenaka', 'Affiliation': 'Clinical Research & Pharmacoepidemiology Department, Medical Affairs Division, Taiho Pharmaceutical Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Sugihara', 'Affiliation': 'Tokyo Medical and Dental University, Tokyo, Japan.'}]",ESMO open,['10.1016/j.esmoop.2021.100077'] 2474,33706433,[Effect of autologous skin paste on repairing wound of donor site of medium-thickness skin graft].,"Objective: To explore the effect of autologous skin paste on repairing wound of medium-thickness skin donor site. Methods: The prospective randomized controlled research method was applied. From October 2018 to December 2019, 18 patients with flame burn or hydrothermal scald, met the inclusion criteria were admitted to Jinhua Hospital Affiliated to Zhejiang University School of Medicine, including 15 males and 3 females, aged (45±6) years, and the wounds were repaired with medium-thickness skin grafts. The wound area after medium-thickness skin grafting was (121±33) cm2. The wound of donor site of medium-thickness skin graft in each patient was divided into 2 wounds in equal area and included into autologous skin paste group and conventional treatment group with random number table, with 18 wounds in each group.The wounds in autologous skin paste group were repaired with skin paste prepared with remaining skin fragments after autologous medium-thickness skin grafting, and the wounds in conventional treatment group were repaired with petroleum jelly gauze and sterile gauze. On 3, 7, 14, 21 d after operation, the wound healing in 2 groups was observed, and the wound healing rate was calculated. The wound healing time in 2 groups was recorded. Occurrences of subcutaneous effusion and infection on 3, 7, 14, 21 d after operation and wound rupture in 3 months after operation were observed. In 6 months after operation, the Vancouver scar scale (VSS) was used to evaluate the scar formation of wounds in 2 groups. Data were statistically analyzed with analysis of variance for repeated measurement, chi-square test, and group t test. Results: The wounds in 2 groups did not heal on 3 and 7 d after operation. The wound healing rate in autologous skin paste group was (29.8±2.5)% and (95.6±4.7)% on 14 and 21 d after operation, which were significantly higher than (25.8±2.9)% and (82.6±8.9)% in conventional treatment group (t=4.3, 5.6, P<0.01). The wound healing time in autologous skin paste group was (21.8±1.4) d, which was significantly shorter than (25.6±2.0) d in conventional treatment group (t=6.24, P<0.01). On 3, 7, 14, 21 d after operation, there were no complications such as subcutaneous effusion and infection in wounds of 2 groups. In 3 months after operation, ulceration occurred in wounds of 2 patients in autologous skin paste group, which was significantly less than 12 patients in conventional treatment group (χ2=11.688, P＜0.01). The wounds with ulceration healed after dressing change. In 6 months after operation, the VSS score of wounds in autologous skin paste group was (9.1±1.1) points, which was significantly lower than (11.3±1.2) points in conventional treatment group (t=-5.75, P＜0.01). Conclusion: The remaining fragments after autologous medium-thickness skin grafting are prepared into skin paste to repair wound of donor site of medium-thickness skin graft can shorten wound healing time, improve wound healing quality, reduce degree of scar hyperplasia, which has a good clinical effect.",2021,"On 3, 7, 14, 21 d after operation, there were no complications such as subcutaneous effusion and infection in wounds of 2 groups.","['From October 2018 to December 2019, 18 patients with flame burn or hydrothermal scald, met the inclusion criteria were admitted to Jinhua Hospital Affiliated to Zhejiang University School of Medicine, including 15 males and 3 females, aged (45±6) years, and the wounds were repaired with medium-thickness skin grafts']","['skin paste prepared with remaining skin fragments after autologous medium-thickness skin grafting, and the wounds in conventional treatment group were repaired with petroleum jelly gauze and sterile gauze', 'autologous skin paste group and conventional treatment group with random number table', 'autologous skin paste']","['repairing wound of donor site of medium-thickness skin graft', 'scar formation of wounds', 'wound healing time', 'wound healing quality', 'wound healing', 'VSS score of wounds', 'Vancouver scar scale (VSS', 'ulceration', 'wound rupture', 'subcutaneous effusion and infection', 'wound healing rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0332691', 'cui_str': 'Scalding injury'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0423756', 'cui_str': 'Thickness of skin'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0423756', 'cui_str': 'Thickness of skin'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0031262', 'cui_str': 'Petrolatum'}, {'cui': 'C0590323', 'cui_str': 'Gauzes'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039224', 'cui_str': 'Table'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C1444716', 'cui_str': 'Donor site'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0423756', 'cui_str': 'Thickness of skin'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0259768', 'cui_str': 'Wound dehiscence'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0013687', 'cui_str': 'Effusion'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",18.0,0.00874687,"On 3, 7, 14, 21 d after operation, there were no complications such as subcutaneous effusion and infection in wounds of 2 groups.","[{'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Mao', 'Affiliation': 'Department of Burns and Plastic Surgery, Affiliated Jinhua Hospital, Zhejiang University School of Medicine, Jinhua 321000, China.'}, {'ForeName': 'Y P', 'Initials': 'YP', 'LastName': 'Wang', 'Affiliation': 'Department of Burns and Plastic Surgery, Affiliated Jinhua Hospital, Zhejiang University School of Medicine, Jinhua 321000, China.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Burns and Plastic Surgery, Affiliated Jinhua Hospital, Zhejiang University School of Medicine, Jinhua 321000, China.'}, {'ForeName': 'W Z', 'Initials': 'WZ', 'LastName': 'Wang', 'Affiliation': 'Department of Burns and Plastic Surgery, Affiliated Jinhua Hospital, Zhejiang University School of Medicine, Jinhua 321000, China.'}, {'ForeName': 'W B', 'Initials': 'WB', 'LastName': 'Zhan', 'Affiliation': 'Department of Burns and Plastic Surgery, Affiliated Jinhua Hospital, Zhejiang University School of Medicine, Jinhua 321000, China.'}, {'ForeName': 'J Z', 'Initials': 'JZ', 'LastName': 'Ma', 'Affiliation': 'Department of Burns and Plastic Surgery, Affiliated Jinhua Hospital, Zhejiang University School of Medicine, Jinhua 321000, China.'}, {'ForeName': 'X G', 'Initials': 'XG', 'LastName': 'Chou', 'Affiliation': 'Department of Burns and Plastic Surgery, Affiliated Jinhua Hospital, Zhejiang University School of Medicine, Jinhua 321000, China.'}]",Zhonghua shao shang za zhi = Zhonghua shaoshang zazhi = Chinese journal of burns,['10.3760/cma.j.cn501120-20200304-00121'] 2475,33705182,Age and intranasal oxytocin effects on trust-related decisions after breach of trust: Behavioral and brain evidence.,"Age-related differences in cognition and socioemotional functions, and in associated brain regions, may reduce sensitivity to cues of untrustworthiness, with effects on trust-related decision making and trusting behavior. This study examined age-group differences in brain activity and behavior during a trust game. In this game, participants received ""breach-of-trust"" feedback after half of the trials. The feedback indicated that only 50% of the monetary investment into their fellow players had resulted in returns. The study also explored the effects of intranasal oxytocin on trust-related decisions in aging, based on suggestions of a modulatory role of oxytocin in response to negative social stimuli and perceptions of trust. Forty-seven younger and 46 older participants self-administered intranasal oxytocin or placebo, in a randomized, double-blind, between-subjects procedure, before they engaged in the trust game while undergoing functional magnetic resonance imaging (fMRI). Younger participants invested less into their game partners after breach-of-trust feedback, while older participants showed no significant difference in their investment after breach-of-trust feedback. Oxytocin did not modulate the behavioral effects. However, after breach-of-trust feedback, older participants in the oxytocin group showed less activity in the left superior temporal gyrus. In contrast, older participants in the placebo group showed more activity in left superior temporal gyrus after breach of trust. The findings may reflect reduced responsiveness to cues of untrustworthiness in older adults. Furthermore, the modulatory effect of oxytocin on left superior temporal gyrus activity among older adults supports the neuropeptide's age-differential role in neural processes in aging, including in the context of trust-related decision making. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"Age-related differences in cognition and socioemotional functions, and in associated brain regions, may reduce sensitivity to cues of untrustworthiness, with effects on trust-related decision making and trusting behavior.","['older adults', 'Forty-seven younger and 46 older participants self-administered']","['functional magnetic resonance imaging (fMRI', 'Oxytocin', 'intranasal oxytocin', 'placebo', 'oxytocin', 'intranasal oxytocin or placebo']","['brain activity and behavior', 'behavioral effects', 'activity']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.142375,"Age-related differences in cognition and socioemotional functions, and in associated brain regions, may reduce sensitivity to cues of untrustworthiness, with effects on trust-related decision making and trusting behavior.","[{'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Frazier', 'Affiliation': 'Department of Psychology, University of Florida.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': 'Department of Psychology, University of Florida.'}, {'ForeName': 'Peiwei', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Department of Psychology, University of Florida.'}, {'ForeName': 'Sondre', 'Initials': 'S', 'LastName': 'Skarsten', 'Affiliation': 'Department of Psychology, University of Florida.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Feifel', 'Affiliation': 'Department of Psychiatry, University of California, San Diego.'}, {'ForeName': 'Natalie C', 'Initials': 'NC', 'LastName': 'Ebner', 'Affiliation': 'Department of Psychology, University of Florida.'}]",Psychology and aging,['10.1037/pag0000545'] 2476,33710717,"Oral semaglutide improves postprandial glucose and lipid metabolism, and delays gastric emptying, in subjects with type 2 diabetes.","AIM To assess the effects of oral semaglutide on postprandial glucose and lipid metabolism, and gastric emptying, in subjects with type 2 diabetes (T2D). MATERIALS AND METHODS In this randomized, double-blind, single-centre, crossover trial, subjects with T2D received once-daily oral semaglutide (escalated to 14 mg) followed by placebo, or vice versa, over two consecutive 12-week periods. Glucose and lipid metabolism, and gastric emptying (paracetamol absorption) were assessed before and after two types of standardized meals (standard and/or fat-rich) at the end of each treatment period. The primary endpoint was area under the glucose 0-5-h curve (AUC 0-5h ) after the standard breakfast. RESULTS Fifteen subjects were enrolled (mean age 58.2 years, HbA1c 6.9%, body weight 93.9 kg, diabetes duration 3.1 years; 13 [86.7%] males). Fasting concentrations of glucose were significantly lower, and C-peptide significantly greater, with oral semaglutide versus placebo. Postprandial glucose (AUC 0-5h ) was significantly lower with oral semaglutide versus placebo (estimated treatment ratio, 0.71; 95% CI, 0.63, 0.81; p < .0001); glucose incremental AUC (iAUC 0-5h/5h ) and glucagon AUC 0-5h were also significantly reduced, with similar results after the fat-rich breakfast. Fasting concentrations of triglycerides, very low-density lipoprotein (VLDL) and apolipoprotein B48 (ApoB48) were significantly lower with oral semaglutide versus placebo. AUC 0-8h for triglycerides, VLDL and ApoB48, and triglycerides iAUC 0-8h/8h , were significantly reduced after oral semaglutide versus placebo. During the first postprandial hour, gastric emptying was delayed (a 31% decrease in paracetamol AUC 0-1h ) with oral semaglutide versus placebo. One serious adverse event (acute myocardial infarction) occurred during oral semaglutide treatment. CONCLUSION Oral semaglutide significantly improved fasting and postprandial glucose and lipid metabolism, and delayed gastric emptying.",2021,"Fasting concentrations of glucose were significantly lower, and C-peptide significantly greater, with oral semaglutide versus placebo.","['subjects with type 2 diabetes', 'subjects with type 2 diabetes (T2D', 'Fifteen subjects were enrolled (mean age 58.2\u2009years, glycated haemoglobin 6.9%, body weight 93.9\u2009kg, diabetes duration 3.1\u2009years; 13 [86.7%] males']","['placebo', 'oral semaglutide', 'placebo, or vice versa', 'Oral semaglutide']","['postprandial glucose and lipid metabolism, and gastric emptying', 'serious adverse event (acute myocardial infarction', 'fasting and postprandial glucose and lipid metabolism, and delayed gastric emptying', 'Fasting concentrations of glucose', 'glucose incremental AUC (iAUC 0-5h/5h ) and glucagon AUC 0-5h', 'postprandial glucose and lipid metabolism, and delays gastric emptying', 'Fasting concentrations of triglycerides, very low-density lipoprotein (VLDL) and apolipoprotein B48 (ApoB48', 'gastric emptying', 'area under the glucose 0-5-hour curve (AUC 0-5h ', 'Glucose and lipid metabolism, and gastric emptying (paracetamol absorption', 'Postprandial glucose (AUC 0-5h ', 'AUC 0-8h for triglycerides, VLDL and ApoB48, and triglycerides iAUC 0-8h/8h']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4517826', 'cui_str': '6.9'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1442467', 'cui_str': '5 hours'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0103839', 'cui_str': 'Apolipoprotein B-48'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}]",15.0,0.118673,"Fasting concentrations of glucose were significantly lower, and C-peptide significantly greater, with oral semaglutide versus placebo.","[{'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Dahl', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Brooks', 'Affiliation': 'Covance Clinical Research Unit Ltd, Leeds, UK.'}, {'ForeName': 'Firas', 'Initials': 'F', 'LastName': 'Almazedi', 'Affiliation': 'Covance Clinical Research Unit Ltd, Leeds, UK.'}, {'ForeName': 'Søren Tetens', 'Initials': 'ST', 'LastName': 'Hoff', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Boschini', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Tine A', 'Initials': 'TA', 'LastName': 'Baekdal', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14373'] 2477,33707410,[Cognitive-behavioral therapy as a damper of the negative psychological effects of confinement by COVID-19 on pregnant women.],"OBJECTIVE The pandemic caused by COVID-19, at a psychological level, can cause an increase in levels of stress and anxiety due to the fear of contagion and its consequences. Pregnant women are especially vulnerable to these psychological consequences. Thus, the objective of this study was to verify the efficacy of a cognitive-behavioral stress control program in reducing psychological stress and increasing resilience in pregnant women, which ended at the begining of the confinement due to COVID-19 in Spain. METHODS The study included 22 pregnant women who were randomly divided into two groups: the experimental group (GT) consisted of 11 participants and the control group (GC) also consisted of 11 participants. Participants were recruited from the Hospital Universitario Clínico San Cecilio in the province of Granada (Spain), where the weekly cognitive behavioral intervention was also carried out, which was implemented between January 22 and March 11, 2020. They used the assessment instruments: Pregnancy Distress Questionnaire (PDQ), Perceived Stress Scale (EEP-14), Inventory of Vulnerability to Stress (IVE) and Connor Davidson Resilience Scale (CD-RISC). A mixed ANOVA of repeated measures 2*2 was performed, with the variable between groups having two levels (CG and GT), and the within-subject having two time periods (pre and post). RESULTS The repeated measures ANOVA analysis showed group*time interaction effects between the therapy group and the control group and the CD-RISC scores (F 1,20 =10.658; p<0.02). Intrasubject differences in CD-RISC scores were found in the (GT) (t=-2.529; p<0.05), with a moderate effect size. CONCLUSIONS It can be affirmed that cognitive behavioral intervention in pregnant women, administrated prior to confinement in Spain and during the COVID-19 pandemic, has resulted in increased levels of resilience in this population.",2021,"They used the assessment instruments: Pregnancy Distress Questionnaire (PDQ), Perceived Stress Scale (EEP-14), Inventory of Vulnerability to Stress (IVE) and Connor Davidson Resilience Scale (CD-RISC).","['Participants were recruited from the Hospital Universitario Clínico San Cecilio in the province of Granada (Spain), where the weekly cognitive behavioral intervention was also carried out, which was implemented between January 22 and March 11, 2020', '22 pregnant women', 'pregnant women, which ended at the begining of the confinement due to COVID-19 in Spain', 'pregnant women', 'Pregnant women']","['cognitive behavioral intervention', 'Cognitive-behavioral therapy', 'control group (GC', 'cognitive-behavioral stress control program']","['group*time interaction effects', 'Pregnancy Distress Questionnaire (PDQ), Perceived Stress Scale (EEP-14), Inventory of Vulnerability to Stress (IVE) and Connor Davidson Resilience Scale (CD-RISC', 'psychological stress', 'CD-RISC scores', 'levels of stress and anxiety']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",22.0,0.0211288,"They used the assessment instruments: Pregnancy Distress Questionnaire (PDQ), Perceived Stress Scale (EEP-14), Inventory of Vulnerability to Stress (IVE) and Connor Davidson Resilience Scale (CD-RISC).","[{'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Puertas-Gonzalez', 'Affiliation': 'Centro de Investigación Mente, Cerebro y Comportamiento (CIMCYC). Granada. España.'}, {'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Romero-Gonzalez', 'Affiliation': 'Centro de Investigación Mente, Cerebro y Comportamiento (CIMCYC). Granada. España.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Mariño-Narvaez', 'Affiliation': 'Centro de Investigación Mente, Cerebro y Comportamiento (CIMCYC). Granada. España.'}, {'ForeName': 'Milagros', 'Initials': 'M', 'LastName': 'Cruz-Martinez', 'Affiliation': 'Departamento de Obstetricia y Ginecología del Hospital Universitario Clínico San Cecilio. Granada. España.'}, {'ForeName': 'Maria Isabel', 'Initials': 'MI', 'LastName': 'Peralta-Ramirez', 'Affiliation': 'Departamento de Personalidad, Evaluación y Tratamiento Psicológico. Facultad de Psicología. Universidad de Granada. Granada. España.'}]",Revista espanola de salud publica,[] 2478,33723616,A rehabilitation programme focussing on pelvic floor muscle training for persistent lumbopelvic pain after childbirth: A randomized controlled trial.,"OBJECTIVE To evaluate the effects of a rehabilitation programme for lumbopelvic pain after childbirth. METHODS Women with lumbopelvic pain 3 months postpartum were included in a randomized controlled trial. Patients in the intervention group (n = 48) received pelvic floor muscle training combined with neuromuscular electrical stimulation of the paraspinal muscles for 12 weeks, while patients in the control group (n = 48) received neuromuscular electrical stimulation for 12 weeks. Outcomes were measured with the Triple Numerical Pain Rating Scale (NPRS), Modified Oswestry Disability Questionnaire (MODQ) and Short-Form Health Survey-36 (SF-36). RESULTS The NPRS score was significantly better in the intervention group at 12 weeks compared with the control group (p = 0.000). The MODQ score was significantly better at 6 and 12 weeks compared with the control group (p = 0.009 and p = 0.015, respectively). The mean value of the Physical Components Summary of the SF-36, was significantly better in the intervention group at 6 weeks (p = 0.000) and 12 weeks (p = 0.000) compared with the control group, but there was no significant improvement in Mental Components Summary of the SF-36. CONCLUSION A postpartum programme for women with lumbopelvic pain is feasible and improves the physical domain of quality of life.",2021,The NPRS score was significantly better in the intervention group at 12 weeks compared with the control group (p = 0.000).,"['persistent lumbopelvic pain after childbirth', 'lumbopelvic pain after childbirth', 'women with lumbopelvic pain', 'Women with lumbopelvic pain 3 months postpartum']","['stabilization strengthening exercises', 'biofeedback-assisted pelvic floor muscle training', 'pelvic floor muscle training', 'neuromuscular electrical stimulation', 'rehabilitation programme, focusing on biofeedback-assisted pelvic floor muscle training', 'biofeedback-assisted pelvic floor muscle training in combination with neuromuscular electrical stimulation of the paraspinal muscles']","['NPRS score', 'MODQ score', 'Mental Components Summary of the SF-36', 'mean value of the Physical Components Summary of the SF-36', 'Triple Numerical Pain Rating Scale (NPRS), Modified Oswestry Disability Questionnaire (MODQ) and Short-Form Health Survey-36 (SF-36', 'Mental Components Summary score']","[{'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]","[{'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0448353', 'cui_str': 'Deep muscle of back'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",,0.0560582,The NPRS score was significantly better in the intervention group at 12 weeks compared with the control group (p = 0.000).,"[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of gynecology and obstetrics, The Third Affiliated Hospital of Southern Medical University, China.'}, {'ForeName': 'Xiaolan', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': ''}, {'ForeName': 'Zishu', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Ribo', 'Initials': 'R', 'LastName': 'Xiong', 'Affiliation': ''}]",Journal of rehabilitation medicine,['10.2340/16501977-2812'] 2479,33722312,Increasing dietary calcium intake of children and their parents: a randomised controlled trial.,"OBJECTIVE Approximately 25 % of Canadian children aged 4-8 years fail to meet the recommended dietary allowance (RDA) of calcium (Ca). Young children's food choices are primarily determined by their parents. No interventions have directly targeted parents as a medium through which to increase children's Ca consumption. This study compared the effectiveness of a Ca-specific intervention targeted towards parents, with generic dietary advice on the Ca consumption of children aged 4-10 years. DESIGN A parallel two-arm randomised controlled trial was conducted. SETTING The study was conducted across Canada. Both conditions received information on the RDA of Ca and an index of intake requirements. Material sent to the intervention condition included behavioural strategies to increase dietary Ca consumption, information on the benefits of dietary Ca intake and messages addressing perceived barriers to the consumption of Ca-rich foods. PARTICIPANTS A total of 239 parents (93 % mothers) of children aged 4-10 years who consumed less than the RDA of Ca were randomly assigned in a 1:1 allocation ratio. RESULTS There was a significant increase in total Ca intake and Ca from dairy for children at weeks 8, 34 and 52 (P ≤ 0·001) in both conditions. Parental Ca intake and amount spent on dairy products did not significantly increase following the intervention. CONCLUSIONS Provision of daily Ca requirements with regular reminders could impact parents' delivery of Ca-rich foods to their children. This finding is important for public health messaging as it suggests that parents are a potent medium through which to promote Ca intake in children.",2021,"There was a significant increase in total calcium intake and calcium from dairy for children at weeks 8, 34 and 52 (ps ≤.001) in both conditions.","['A total of 239 parents (93% mothers) of children aged 4-10 years who consumed less than the RDA of calcium', 'Approximately 25% of Canadian children aged 4-8 years', 'children aged 4-10 years']","['dietary allowance (RDA) of calcium', 'calcium-specific intervention']","['Parental calcium intake and amount spent on dairy products', 'total calcium intake and calcium']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0524787', 'cui_str': 'Recommended Dietary Allowance'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0524787', 'cui_str': 'Recommended Dietary Allowance'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake'}, {'cui': 'C0010947', 'cui_str': 'Dairy foods'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}]",239.0,0.127043,"There was a significant increase in total calcium intake and calcium from dairy for children at weeks 8, 34 and 52 (ps ≤.001) in both conditions.","[{'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Bourne', 'Affiliation': 'Centre for Exercise, Nutrition and Health Sciences, School of Policy Studies, University of Bristol, 8 Priory Road, BristolBS8 1TZ, UK.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Martin Ginis', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Kelowna, Canada.'}, {'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Buchholz', 'Affiliation': 'Department of Family Relations and Applied Nutrition, University of Guelph, Guelph, Canada.'}, {'ForeName': 'Skylar', 'Initials': 'S', 'LastName': 'Schmidtke', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Kelowna, Canada.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Jung', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Kelowna, Canada.'}]",Public health nutrition,['10.1017/S1368980021001087'] 2480,33720917,External Splinting Is Not Mandatory After All Rhinoplasties: A Prospective Randomized Trial.,"BACKGROUND Although casts or external splint materials are commonly applied on the external nose after rhinoplasty, their beneficial effects have not been previously demonstrated in controlled studies. METHODS A total of 40 adult patients who underwent primary rhinoplasty were included in this prospective study. The patients were randomized into 2 groups to use an external splint or not after surgery. Only surgical taping was applied to the nasal dorsum of the patients for whom external splints were not used. The periorbital edema and ecchymosis levels of the patients were recorded on the second and seventh days after surgery. Moreover, all patients had a computed tomography scan at the third postoperative week to measure the distance between the beginning of the osteotomy line on the right and left sides and the midline. RESULTS On the second and seventh postoperative days, the levels of periorbital edema and ecchymosis were significantly lower in the patients with taping than in the patients with splints (P < 0.05 for each). No statistically significant difference was observed in terms of the difference in the distance between the beginning of the osteotomy line on the right and left sides to the midline between the group with external splints and that with tape (P = 0.661). CONCLUSIONS External splinting may not be used in cases where osteotomy is not performed or in patients where the osteotomies are sufficiently stable. Thus, the disadvantages of external splinting are avoided, and at the same time, periorbital edema and ecchymosis are less common.",2021,"On the second and seventh postoperative days, the levels of periorbital edema and ecchymosis were significantly lower in the patients with taping than in the patients with splints (P < 0.05 for each).",['40 adult patients who underwent primary rhinoplasty'],"['External Splinting', 'external splint or not after surgery']","['levels of periorbital edema and ecchymosis', 'computed tomography scan', 'periorbital edema and ecchymosis levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0035467', 'cui_str': 'Rhinoplasty'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0204861', 'cui_str': 'Application of splint'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0151205', 'cui_str': 'Periorbital edema'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]",40.0,0.0133111,"On the second and seventh postoperative days, the levels of periorbital edema and ecchymosis were significantly lower in the patients with taping than in the patients with splints (P < 0.05 for each).","[{'ForeName': 'Cavid', 'Initials': 'C', 'LastName': 'Cabbarzade', 'Affiliation': 'From the Department of Otorhinolaryngology, Azerbaijan Medical University, Baku, Azerbaijan.'}, {'ForeName': 'Ömer Taşkin', 'Initials': 'ÖT', 'LastName': 'Yücel', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Hacettepe University.'}, {'ForeName': 'Tevfik', 'Initials': 'T', 'LastName': 'Sözen', 'Affiliation': 'Private Practice, Ankara, Turkey.'}, {'ForeName': 'Burce', 'Initials': 'B', 'LastName': 'Ozgen', 'Affiliation': 'Department of Radiology, University of Illinois at Chicago, Chicago, IL.'}]",Annals of plastic surgery,['10.1097/SAP.0000000000002710'] 2481,33724391,Effectiveness of Standard Local Anesthetic Bupivacaine and Liposomal Bupivacaine for Postoperative Pain Control in Patients Undergoing Truncal Incisions: A Randomized Clinical Trial.,"Importance Liposomal bupivacaine for pain relief is purported to last 3 days compared with 8 hours with standard bupivacaine. However, its effectiveness is unknown in truncal incisions for cardiothoracic or vascular operations. Objective To compare the effectiveness of single-administration standard bupivacaine vs liposomal bupivacaine in patients undergoing truncal incisions. Design, Setting, and Participants This randomized clinical trial enrolled patients undergoing sternotomy, thoracotomy, minithoracotomy, and laparotomy from a single cardiovascular surgery department in an academic medical center between November 2012 and June 2018. The study was powered to detect a Cohen effect size of 0.35 with a power of greater than 80%. Data analysis was performed from July to December 2018. Intervention Patients were randomized to standard bupivacaine or liposomal bupivacaine. Main Outcomes and Measures Pain was assessed over 3 postoperative days by the Numeric Rating Scale (NRS). Adjunctive opioids were converted to morphine equivalents units (MEU). NRS scores were compared using Wilcoxon rank-sum (3-day area under the curve) and 2-way nonparametric mixed models (daily scale score) to assess time-by-group interaction. Secondary outcomes included cumulative opioid consumption. Results A total of 280 patients were analyzed, with 140 in each group (single-administration standard bupivacaine vs liposomal bupivacaine). Mean (SD) age was 60.2 (14.4) years, and 101 of 280 patients (36%) were women. Irrespective of treatment assignment, pain decreased by a mean of approximately 1 point per day over 3 days (β = -0.87; SE = 0.11; mixed model regression P < .001). Incision type was associated with pain with patients undergoing thoracotomy (including minithoracotomy) reporting highest median (interquartile range [IQR]) pain scores on postoperative days 1 (liposomal vs standard bupivacaine, 6 [4-8] vs 5 [3-7]; P = .049, Wilcoxon rank-sum) and 2 (liposomal vs standard bupivacaine, 5 [4-7] vs 4 [2-6]; P = .003, Wilcoxon rank-sum) but not day 3 (liposomal vs standard bupivacaine, 3 [2-6] vs 3 [1-5]; P = .10, Wilcoxon rank-sum), irrespective of treatment group. Median (IQR) 3-day cumulative NRS was 12.0 (8.0-16.5) for bupivacaine and 13.5 (9.0-17.0) for liposomal bupivacaine (P = .15, Wilcoxon rank-sum) Furthermore, use of opioids was greater following liposomal bupivacaine compared with standard bupivacaine (median [IQR], 41.5 [21.3-73.8] MEU vs 33.0 [17.8-62.5] MEU; P = .03, Wilcoxon rank-sum). On multivariable analysis, no interaction by incision type was observed for mean pain scores or opioid use. Conclusions and Relevance In this randomized clinical trial involving truncal incisions for cardiovascular procedures, liposomal bupivacaine did not provide improved pain control and did not reduce adjunctive opioid use compared with conventional bupivacaine formulation over 3 postoperative days. Trial Registration ClinicalTrials.gov Identifier: NCT02111746.",2021,"In this randomized clinical trial involving truncal incisions for cardiovascular procedures, liposomal bupivacaine did not provide improved pain control and did not reduce adjunctive opioid use compared with conventional bupivacaine formulation over 3 postoperative days. ","['patients undergoing truncal incisions', 'patients undergoing sternotomy, thoracotomy, minithoracotomy, and laparotomy from a single cardiovascular surgery department in an academic medical center between November 2012 and June 2018', '280 patients', 'Mean (SD) age was 60.2 (14.4) years, and 101 of 280 patients (36%) were women', 'Patients Undergoing Truncal Incisions']","['standard bupivacaine', 'liposomal bupivacaine', 'truncal incisions', 'bupivacaine', 'liposomal vs standard bupivacaine', 'conventional bupivacaine', 'Standard Local Anesthetic Bupivacaine and Liposomal Bupivacaine', 'bupivacaine or liposomal bupivacaine', 'bupivacaine vs liposomal bupivacaine', 'Liposomal bupivacaine']","['pain', 'Measures\n\n\nPain', 'Numeric Rating Scale (NRS', 'mean pain scores', 'Median (IQR) 3-day cumulative NRS', 'highest median (interquartile range [IQR]) pain scores', 'cumulative opioid consumption', 'pain relief', 'NRS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0185792', 'cui_str': 'Sternotomy'}, {'cui': 'C0039991', 'cui_str': 'Chest wall incision'}, {'cui': 'C0405917', 'cui_str': 'Limited thoracotomy'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0038897', 'cui_str': 'Cardiovascular surgical procedure'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",280.0,0.41505,"In this randomized clinical trial involving truncal incisions for cardiovascular procedures, liposomal bupivacaine did not provide improved pain control and did not reduce adjunctive opioid use compared with conventional bupivacaine formulation over 3 postoperative days. ","[{'ForeName': 'Harleen K', 'Initials': 'HK', 'LastName': 'Sandhu', 'Affiliation': 'McGovern Medical School at the University of Texas Health Science Center at Houston.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Miller', 'Affiliation': 'McGovern Medical School at the University of Texas Health Science Center at Houston.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Tanaka', 'Affiliation': 'McGovern Medical School at the University of Texas Health Science Center at Houston.'}, {'ForeName': 'Anthony L', 'Initials': 'AL', 'LastName': 'Estrera', 'Affiliation': 'McGovern Medical School at the University of Texas Health Science Center at Houston.'}, {'ForeName': 'Kristofer M', 'Initials': 'KM', 'LastName': 'Charlton-Ouw', 'Affiliation': 'McGovern Medical School at the University of Texas Health Science Center at Houston.'}]",JAMA network open,['10.1001/jamanetworkopen.2021.0753'] 2482,33729467,Morbidity and Mortality of Patients Who Underwent Minimally Invasive Esophagectomy After Neoadjuvant Chemoradiotherapy vs Neoadjuvant Chemotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma: A Randomized Clinical Trial.,"Importance Safety and efficacy of neoadjuvant chemoradiotherapy (nCRT) vs neoadjuvant chemotherapy (nCT) for treatment of locally advanced esophageal squamous cell carcinoma (ESCC) remain uncertain given lack of high-level clinical evidence. Objective To compare safety and long-term survival of nCRT followed by minimally invasive esophagectomy (MIE) with that of nCT followed by MIE for patients with locally advanced ESCC. Design, Setting, and Participants A prospective, multicenter, open-label, randomized clinical trial that compared safety and efficacy of nCRT vs nCT followed by MIE for patients with locally advanced ESCC. From January 1, 2017, to December 31, 2018, 264 patients with ESCC of clinical stages from cT3 to T4aN0 to 1M0 were enrolled. Analysis was performed on an intention-to-treat basis from January 1, 2017, to August 30, 2020. Interventions Eligible patients were randomized to the nCRT group (n = 132) or the nCT group (n = 132) by a computer-generated random system. The chemotherapy, based on paclitaxel and cisplatin, was administered to both groups, while 40 Gy of concurrent radiotherapy was added for the nCRT group. At about 6 weeks after neoadjuvant therapy, MIE via thoracoscopy and laparoscopy was performed for the patients in both groups. Main Outcomes and Measures The primary outcome was 3-year overall survival. Secondary outcomes included postoperative complications, mortality, postoperative pathologic outcome, recurrence-free survival time, and quality of life. Results Among 264 patients (226 men [85.6%]; mean [SD] age, 61.4 [6.8] years), postoperative morbidity was 47.4% in the nCRT group (54 of 114) and 42.6% in the nCT group (46 of 108), with no significant difference between groups (difference, 4.8%; 95% CI, -8.2% to 17.5%; P = .48). Distribution of the severity of complications was similar between the 2 groups based on Clavien-Dindo classification. The 90-day perioperative mortality rate was 3.5% for the nCRT group (4 of 114) and 2.8% for the nCT group (3 of 108) (P = .94). The R0 resection rates were similar between groups (109 of 112 [97.3%] vs 100 of 104 [96.2%]; P = .92). However, patients in the nCRT group had a higher pathologic complete response (residual tumor, 0%) rate (40 of 112 [35.7%] vs 4 of 104 [3.8%]; P < .001) and a higher rate of negative lymph nodes (ypN0, 74 of 112 [66.1%] vs 48 of 104 [46.2%]; P = .03) than those in the nCT group. One-year overall survival using intention-to-treat analysis was 87.1% in the nCRT group (115 of 132) and 82.6% in the nCT group (109 of 132) (P = .30). Furthermore, deaths caused by tumor progression or recurrence were significantly less in the nCRT group than in the nCT group (9 of 132 [6.8%] vs 19 of 132 [14.4%]; P = .046); however, deaths from nontumor causes were similar (8 of 132 [6.1%] vs 4 of 132 [3.0%]; P = .24). Conclusions and Relevance Initial results of the trial showed that nCRT followed by MIE has similar safety to and better histopathologic outcome than nCT followed by MIE for treatment of locally advanced ESCC. Trial Registration ClinicalTrials.gov Identifier: NCT03001596.",2021,The R0 resection rates were similar between groups (109 of 112 [97.3%] vs 100 of 104 [96.2%]; P = .92).,"['264 patients (226 men [85.6%]; mean [SD] age, 61.4 [6.8] years', 'From January 1, 2017, to December 31, 2018, 264 patients with ESCC of clinical stages from cT3 to T4aN0 to 1M0 were enrolled', 'locally advanced esophageal squamous cell carcinoma (ESCC', 'Locally Advanced Esophageal Squamous Cell Carcinoma', 'patients with locally advanced ESCC']","['paclitaxel and cisplatin', 'nCT group (n\u2009=\u2009132) by a computer-generated random system', 'MIE via thoracoscopy and laparoscopy', 'neoadjuvant chemoradiotherapy (nCRT) vs neoadjuvant chemotherapy (nCT', 'Invasive Esophagectomy', 'nCRT vs nCT', 'nCT followed by MIE', 'nCRT followed by minimally invasive esophagectomy (MIE', 'nCT', 'nCRT', 'Neoadjuvant Chemoradiotherapy vs Neoadjuvant Chemotherapy']","['postoperative complications, mortality, postoperative pathologic outcome, recurrence-free survival time, and quality of life', '90-day perioperative mortality rate', '3-year overall survival', 'R0 resection rates', 'Morbidity and Mortality', 'pathologic complete response', 'rate of negative lymph nodes', 'tumor progression or recurrence', 'postoperative morbidity', 'severity of complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C0205563', 'cui_str': 'Clinical stage finding'}, {'cui': 'C1175872', 'cui_str': 'CAGE1 protein, human'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0039989', 'cui_str': 'Thoracoscopy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2919551', 'cui_str': 'Duration of recurrence-free survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0178874', 'cui_str': 'Tumor progression'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",264.0,0.127558,The R0 resection rates were similar between groups (109 of 112 [97.3%] vs 100 of 104 [96.2%]; P = .92).,"[{'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Thoracic Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': 'Department of Thoracic Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': 'Department of Thoracic Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Lijie', 'Initials': 'L', 'LastName': 'Tan', 'Affiliation': 'Department of Thoracic Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yin', 'Affiliation': 'Department of Thoracic Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yaxing', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Department of Thoracic Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Zhaochong', 'Initials': 'Z', 'LastName': 'Zeng', 'Affiliation': 'Department of Radiotherapy, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jiangyi', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of Radiotherapy, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yingyong', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': 'Department of Pathology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Du', 'Affiliation': 'Department of Cardiothoracic Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Jiao', 'Affiliation': 'Department of Cardiothoracic Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Hongjing', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Esophageal Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Gong', 'Affiliation': 'Department of Esophageal Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Radiotherapy, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Deyao', 'Initials': 'D', 'LastName': 'Xie', 'Affiliation': 'Department of Thoracic Surgery, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Wenfeng', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Radiation Oncology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Changhong', 'Initials': 'C', 'LastName': 'Lian', 'Affiliation': 'Department of General Surgery, Heping Hospital Affiliated to Changzhi Medical College, Changzhi, Shanxi, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Department of General Surgery, Heping Hospital Affiliated to Changzhi Medical College, Changzhi, Shanxi, China.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, Fujian Medical University Union Hospital, Fuzhou, Fujian, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zheng', 'Affiliation': 'Department of Thoracic Surgery, Fujian Medical University Union Hospital, Fuzhou, Fujian, China.'}, {'ForeName': 'Yongde', 'Initials': 'Y', 'LastName': 'Liao', 'Affiliation': 'Department of Thoracic Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Kuo', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Hecheng', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Dai', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), The First Department of Thoracic Surgery, Peking University Cancer Hospital and Institute, Peking University School of Oncology, Beijing, China.'}, {'ForeName': 'Ke-Neng', 'Initials': 'KN', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), The First Department of Thoracic Surgery, Peking University Cancer Hospital and Institute, Peking University School of Oncology, Beijing, China.'}]",JAMA surgery,['10.1001/jamasurg.2021.0133'] 2483,33729664,Dapagliflozin reduces systolic blood pressure and modulates vasoactive factors.,"AIM To investigate the mechanisms underlying improvements in blood pressure (BP) and congestive heart failure outcomes following treatment with dapagliflozin, a sodium-glucose co-transporter-2 inhibitor. RESEARCH DESIGN AND METHODS A total of 52 patients with type 2 diabetes (T2D) with an HbA1c of less than 8% participated in this prospective, double-blind and placebo-controlled study. Patients were randomized (1:1) to either dapagliflozin 10 mg daily or placebo for 12 weeks. Half the patients were also monitored for 6 h following their first dose for acute effects on BP. Blood and urine samples were collected and levels of angiotensinogen, angiotensin II, renin, aldosterone, endothelin-1, atrial natriuretic peptide (ANP), brain natriuretic peptide, cyclic adenosine monophosphate, cyclic guanosine monophosphate (cGMP) and neprilysin were measured. The expression of angiotensin-converting enzyme, guanylate cyclase and phosphodiesterase 5 (PDE5) was measured in circulating mononuclear cells (MNC). RESULTS A total of 24 and 23 patients receiving dapagliflozin and placebo, respectively, completed the 12-week study. Systolic BP decreased significantly, compared with placebo, both after single-dose (by 7 ± 3 mmHg) and 12-week (by 7 ± 2 mmHg) treatment with dapagliflozin. Dapagliflozin suppressed angiotensin II and angiotensinogen (by 10.5 ± 2.1 and 1.45 ± 0.42 μg/mL, respectively) and increased ANP and cGMP (by 34 ± 11 and 29 ± 11 pmol/mL, respectively) compared with the placebo group. cGMP levels also increased acutely following a single dose of dapagliflozin. Dapagliflozin also suppressed PDE5 expression by 26% ± 11% in MNC. There were no changes observed in the other vasoactive mediators investigated. CONCLUSIONS Dapagliflozin administration in T2D resulted in both acute and chronic reduction in systolic BP, a reduction in vasoconstrictors and an increase in vasodilators. These changes may potentially contribute to its antihypertensive effects and its benefits in congestive cardiac failure.",2021,"Expression of angiotensin converting enzyme, guanylate cyclase and phosphodiesterase 5 (PDE5) were measured in circulating mononuclear cells (MNC). ","['24 and 23 patients receiving', '52 type 2 diabetes patients (T2DM) with HbA1c <8% participated']","['dapagliflozin and placebo', 'dapagliflozin 10\u2009mg daily or placebo', 'dapagliflozin', 'placebo', 'Dapagliflozin']","['blood pressure (BP) and congestive heart failure outcomes', 'Systolic Blood Pressure and Modulates Vasoactive Factors', 'Expression of angiotensin converting enzyme, guanylate cyclase and phosphodiesterase 5 (PDE5', 'angiotensinogen, angiotensin II, renin, aldosterone, endothelin-1, Atrial natriuretic peptide (ANP), brain natriuretic peptide (BNP), Cyclic adenosine monophosphate (cAMP), Cyclic guanosine monophosphate (cGMP) and neprilysin', 'Dapagliflozin suppressed angiotensin II and angiotensinogen', 'PDE5 expression', 'cGMP levels', 'ANP and cGMP', 'Systolic BP', 'systolic BP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0022709', 'cui_str': 'Dipeptidyl carboxypeptidase I'}, {'cui': 'C0018358', 'cui_str': 'Guanylate cyclase'}, {'cui': 'C0757672', 'cui_str': 'Phosphodiesterase 5'}, {'cui': 'C0003017', 'cui_str': 'Angiotensinogen'}, {'cui': 'C0003009', 'cui_str': 'angiotensin II'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0002006', 'cui_str': 'Aldosterone'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0027481', 'cui_str': 'A-type natriuretic peptide'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0018338', 'cui_str': 'Cyclic guanosine monophosphate'}, {'cui': 'C0025250', 'cui_str': 'Lymphocyte antigen CD10'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",52.0,0.232165,"Expression of angiotensin converting enzyme, guanylate cyclase and phosphodiesterase 5 (PDE5) were measured in circulating mononuclear cells (MNC). ","[{'ForeName': 'Husam', 'Initials': 'H', 'LastName': 'Ghanim', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Williamsville, New York, USA.'}, {'ForeName': 'Manav', 'Initials': 'M', 'LastName': 'Batra', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Williamsville, New York, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Green', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Williamsville, New York, USA.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Hejna', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Williamsville, New York, USA.'}, {'ForeName': 'Sanaa', 'Initials': 'S', 'LastName': 'Abuaysheh', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Williamsville, New York, USA.'}, {'ForeName': 'Antione', 'Initials': 'A', 'LastName': 'Makdissi', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Williamsville, New York, USA.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Chaudhuri', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Williamsville, New York, USA.'}, {'ForeName': 'Paresh', 'Initials': 'P', 'LastName': 'Dandona', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Williamsville, New York, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14377'] 2484,33728044,Optimising retention success: a research team's experience of following-up participants recruited to a pilot trial through community pharmacies in England.,"Background : The CHAMP-1 ( Community pharmacy: Highlighting Alcohol use in Medication a Ppointments) pilot trial aimed to explore an intervention discussing alcohol during medication consultations with community pharmacists. It presented various challenges regarding patient retention, as participants were recruited by their pharmacist and followed-up remotely by a trained researcher, who they had not met, two months later.  We discuss our actions and experiences of completing follow-up activities. Methods : Community pharmacists recruited patients aged 18 and over, attending a Medicine Use Review (MUR) or New Medicine Service (NMS) consultation, and drinking alcohol at least twice per week. Pharmacies were randomised to conduct their consultations as usual (control), or to incorporate the Medicines and Alcohol Consultation (MAC) intervention. All participants were followed-up by a researcher after two months to complete data collection via telephone or post. We employed standard follow-up strategies, including a plan to text participants with a reminder in advance of their follow-up. Results : Forty-seven of 51 participants (92%) completed the two month follow-up. Thirty-eight (81%) responses were provided by telephone and nine (19%) by post. Of the 38 follow-up calls completed by telephone, 17 (45%) participants were reached at first attempt; 16 (42%) at second attempt; and five (13%) at the third attempt. We observed a high percentage of data completion across telephone and postal collection methods.  Participants were willing to discuss potentially sensitive issues, such as alcohol consumption, anxiety, and depression, with a researcher who was external to the pharmacy team.  Conclusions : The results suggest that patients recruited to a trial by community pharmacists are willing to take part in data collection activities, and remote follow-up can be successfully conducted by researchers. The techniques employed to encourage high levels of retention should be investigated further in a larger study, alongside consideration of optimal strategies to collect data within community pharmacies.",2020,The CHAMP-1 ( Community pharmacy: Highlighting Alcohol use in Medication a Ppointments) pilot trial aimed to explore an intervention discussing alcohol during medication consultations with community pharmacists.,"['Community pharmacists recruited patients aged 18 and over, attending a Medicine Use Review (MUR) or New Medicine Service (NMS) consultation, and drinking alcohol at least twice per week', 'up participants recruited to a pilot trial through community pharmacies in England']","['conduct their consultations as usual (control), or to incorporate the Medicines and Alcohol Consultation (MAC) intervention', ' ']",[],"[{'cui': 'C0402003', 'cui_str': 'Community pharmacist'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0429792,The CHAMP-1 ( Community pharmacy: Highlighting Alcohol use in Medication a Ppointments) pilot trial aimed to explore an intervention discussing alcohol during medication consultations with community pharmacists.,"[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Watson', 'Affiliation': 'Department of Health Sciences, University of York, York, YO10 5DD, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'van Dongen', 'Affiliation': 'Department of Health Sciences, University of York, York, YO10 5DD, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hewitt', 'Affiliation': 'Department of Health Sciences, University of York, York, YO10 5DD, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mandefield', 'Affiliation': 'Department of Health Sciences, University of York, York, YO10 5DD, UK.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Stewart', 'Affiliation': 'Department of Health Sciences, University of York, York, YO10 5DD, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Watson', 'Affiliation': 'Department of Health Sciences, University of York, York, YO10 5DD, UK.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'McCambridge', 'Affiliation': 'Department of Health Sciences, University of York, York, YO10 5DD, UK.'}]",F1000Research,['10.12688/f1000research.25372.2'] 2485,33729984,The Healing Hearts Together Randomized Controlled Trial and the COVID-19 Pandemic: A Tutorial for Transitioning From an In-Person to a Web-Based Intervention.,"Supportive couple relationships are associated with reduced risk of chronic illness development, such as cardiovascular disease, as well as improved secondary prevention. Healing Hearts Together (HHT) is an 8-week couples-based intervention designed to improve relationship quality, mental health, quality of life, and cardiovascular health among couples in which one partner has experienced a cardiac event. A randomized controlled trial began in October 2019 to test the efficacy of the in-person, group-based HHT program as compared to usual care. In March of 2020, all recruitment, assessments, and interventions halted due to the COVID-19 pandemic. Guided by optimal virtual care principles, as well as by Hom and colleagues' four-stage framework-consultation, adaptation, pilot-testing, and test launch-this paper is a tutorial for the step-by-step transition planning and implementation of a clinical research intervention from an in-person to a web-based format, using the HHT program as an example. Clinical and research considerations are reviewed, including (1) privacy, (2) therapeutic aspects of the intervention, (3) group cohesion, (4) research ethics, (5) participant recruitment, (6) assessment measures, (7) data collection, and (8) data analyses. This tutorial can assist clinical researchers in transitioning their research programs to a web-based format during the pandemic and beyond.",2021,"UNSTRUCTURED Supportive couple relationships are associated with reduced risk of chronic illness development, such as cardiovascular disease, as well as improved secondary prevention.",[],"['COVID-19 Pandemic', 'Healing Hearts Together (HHT', ""Guided by optimal virtual care principles, and Hom and colleagues' (2020) four-stage framework (consultation, adaptation, pilot testing, and test launch""]","['relationship quality, mental health, quality of life, and cardiovascular health']",[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0577521,"UNSTRUCTURED Supportive couple relationships are associated with reduced risk of chronic illness development, such as cardiovascular disease, as well as improved secondary prevention.","[{'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Lalande', 'Affiliation': 'Division of Cardiac Prevention and Rehabilitation, University of Ottawa Heart Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Greenman', 'Affiliation': 'Université du Québec en Outaouais, Gatineau, QC, Canada.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Bouchard', 'Affiliation': 'Division of Cardiac Prevention and Rehabilitation, University of Ottawa Heart Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Johnson', 'Affiliation': 'International Centre for Excellence in Emotionally Focused Therapy, Ottawa, ON, Canada.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Tulloch', 'Affiliation': 'Division of Cardiac Prevention and Rehabilitation, University of Ottawa Heart Institute, Ottawa, ON, Canada.'}]",Journal of medical Internet research,['10.2196/25502'] 2486,33727868,Time to Long-Acting Reversible Contraceptive Uptake Over Twelve Months Postpartum: Findings of the Yam Daabo Cluster Randomized-Controlled Trial in Burkina Faso and the Democratic Republic of the Congo.,"Purpose An earlier adoption of contraceptive methods during the postpartum period could help women to extend the inter-pregnancy interval. This article aimed to determine and compare the timing of long-acting reversible contraceptives (LARC) use (ie, intrauterine device and implant) in Burkina Faso (BF) and DR Congo (DRC) between the intervention and control groups. Patients and Methods A total of 1120 postpartum women were enrolled and followed up to 12 months postpartum. We used Yam-Daabo trial data which was a multi-intervention, single-blinded, cluster-randomised controlled trial done in primary health-care centres (clusters) in both countries. Centres were randomly allocated to receive the six-component intervention or standard antenatal and postnatal care in matched pairs (1:1). We did a secondary analysis using Royston-Parmar's semi-parametric model to estimate the effect of the interventions on the median time of LARC uptake. Results Our analysis included 567 postpartum women in BF (284 in the intervention group and 283 in the control group) and 553 in the DRC (274 in the intervention group and 279 in the control group). After showing an increase in family planning use in these two African countries, Yam Daabo's interventions showed a reduction of the median time of LARCs adoption in the intervention group compared to the control group in both countries (difference of 39 days in Burkina Faso; difference of 86 days in the DR Congo). Conclusion The Yam Daabo intervention package resulted in increased and earlier adoption of LARC in rural settings in Burkina Faso and urban settings in DR Congo. Such an intervention could be relevant in similar contexts in Sub-Saharan Africa with very high fertility rates and high unmet needs for contraception.",2021,The Yam Daabo intervention package resulted in increased and earlier adoption of LARC in rural settings in Burkina Faso and urban settings in DR Congo.,"['Postpartum', '567 postpartum women in BF (284 in the intervention group and 283 in the control group) and 553 in the DRC (274 in the intervention group and 279 in the control group', 'Patients and Methods\n\n\nA total of 1120 postpartum women were enrolled and followed up to 12 months postpartum', 'primary health-care centres (clusters) in both countries']","['six-component intervention or standard antenatal and postnatal care', 'long-acting reversible contraceptives (LARC']","['Burkina Faso (BF) and DR Congo (DRC', 'median time of LARCs adoption', 'Time to Long-Acting Reversible Contraceptive Uptake', 'median time of LARC uptake']","[{'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0006409', 'cui_str': 'Burkina Faso'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}]","[{'cui': 'C0006409', 'cui_str': 'Burkina Faso'}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}]",1120.0,0.0821203,The Yam Daabo intervention package resulted in increased and earlier adoption of LARC in rural settings in Burkina Faso and urban settings in DR Congo.,"[{'ForeName': 'Abou', 'Initials': 'A', 'LastName': 'Coulibaly', 'Affiliation': 'Institut de Recherche en Sciences de la Santé (IRSS), Département Biomédical et Santé Publique, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Tieba', 'Initials': 'T', 'LastName': 'Millogo', 'Affiliation': 'Institut Africain de Santé Publique, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Adama', 'Initials': 'A', 'LastName': 'Baguiya', 'Affiliation': 'Institut de Recherche en Sciences de la Santé (IRSS), Département Biomédical et Santé Publique, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Nguyen Toan', 'Initials': 'NT', 'LastName': 'Tran', 'Affiliation': 'University of Technology, Faculty of Health, Australian Centre for Public and Population Health Research, Sydney, Australia.'}, {'ForeName': 'Blandine', 'Initials': 'B', 'LastName': 'Thieba', 'Affiliation': 'Université Joseph KI-ZERBO, Unité de Formation et de Recherche en Sciences de la Santé, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Seuc', 'Affiliation': 'World Health Organization, Department of Reproductive Health Research, Geneva, Switzerland.'}, {'ForeName': 'Asa', 'Initials': 'A', 'LastName': 'Cuzin-Kihl', 'Affiliation': 'World Health Organization, Department of Reproductive Health Research, Geneva, Switzerland.'}, {'ForeName': 'Sihem', 'Initials': 'S', 'LastName': 'Landoulsi', 'Affiliation': 'World Health Organization, Department of Reproductive Health Research, Geneva, Switzerland.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kiarie', 'Affiliation': 'World Health Organization, Department of Reproductive Health Research, Geneva, Switzerland.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Yodi', 'Affiliation': 'Université de Kinshasa, Ecole de Santé Publique, Kinshasa, République Démocratique du Congo.'}, {'ForeName': 'Désiré', 'Initials': 'D', 'LastName': 'Mashinda', 'Affiliation': 'Université de Kinshasa, Ecole de Santé Publique, Kinshasa, République Démocratique du Congo.'}, {'ForeName': 'Séni', 'Initials': 'S', 'LastName': 'Kouanda', 'Affiliation': 'Institut de Recherche en Sciences de la Santé (IRSS), Département Biomédical et Santé Publique, Ouagadougou, Burkina Faso.'}]",Open access journal of contraception,['10.2147/OAJC.S287770'] 2487,33734167,Pharmacokinetic Profile of the Asenapine Transdermal System (HP-3070).,"PURPOSE/BACKGROUND The asenapine transdermal system (HP-3070) is the first antipsychotic patch approved in the United States for treatment of adults with schizophrenia. METHODS/PROCEDURES Three phase 1, open-label, randomized studies characterized the pharmacokinetic (PK) profile of HP-3070 by assessing its relative bioavailability compared with sublingual asenapine, its single-/multiple-dose PK and dose proportionality, and the effects of application site, ethnicity, and external heat on bioavailability. Two studies were conducted in healthy subjects, and 1 was conducted in adults with schizophrenia. FINDINGS/RESULTS During single HP-3070 administration, asenapine concentrations increased gradually over approximately 12 hours and remained steady until the patch was removed 24 hours after application. Asenapine area under the curve values at HP-3070 3.8 and 7.6 mg/24 hours doses were similar to those for sublingual asenapine 5 and 10 mg twice-daily doses, respectively, whereas peak exposure (maximum observed plasma concentration) was significantly lower. During daily application of HP-3070, steady-state PK was reached within approximately 72 hours after initiating daily dosing and was characterized by peak-to-trough asenapine plasma concentration ratio of approximately 1.5. HP-3070 PK was dose proportional in the dose range studied, not affected by administration site, and similar across the studied ethnic groups. Application of external heat increased the rate of asenapine absorption (time to reach maximum observed plasma concentration) but did not significantly affect peak and total exposure. IMPLICATIONS/CONCLUSIONS HP-3070 exhibited a dose-dependent PK profile unaffected by site of administration or ethnicity. HP-3070 showed a predictable absorption profile with limited variability, with an area under the curve similar to that of sublingual asenapine. Based on these PK metrics, HP-3070 steadily delivers asenapine with lower peaks and troughs than sublingual administration of asenapine.",2021,"HP-3070 PK was dose proportional in the dose range studied, not affected by administration site, and similar across the studied ethnic groups.","['adults with schizophrenia', 'healthy subjects, and 1 was conducted in adults with schizophrenia']","['Asenapine Transdermal System (HP-3070', 'HP-3070']","['asenapine concentrations', 'Asenapine area under the curve values', 'rate of asenapine absorption']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C2000088', 'cui_str': 'Asenapine'}, {'cui': 'C0991556', 'cui_str': 'Prolonged-release transdermal patch'}]","[{'cui': 'C2000088', 'cui_str': 'Asenapine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}]",,0.068597,"HP-3070 PK was dose proportional in the dose range studied, not affected by administration site, and similar across the studied ethnic groups.","[{'ForeName': 'Katsumi', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'From Product Development, Noven Pharmaceuticals, Inc, Jersey City, NJ Hisamitsu Pharmaceutical Co, Inc, Chiyoda-ku, Tokyo, Japan Psychiatry and Behavioral Sciences, New York Medical College, Valhalla, NY.'}, {'ForeName': 'Mariacristina', 'Initials': 'M', 'LastName': 'Castelli', 'Affiliation': ''}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Komaroff', 'Affiliation': ''}, {'ForeName': 'Brittney', 'Initials': 'B', 'LastName': 'Starling', 'Affiliation': ''}, {'ForeName': 'Takaaki', 'Initials': 'T', 'LastName': 'Terahara', 'Affiliation': ''}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Citrome', 'Affiliation': ''}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001383'] 2488,33734144,Continuous Pectoral Nerve Block Compared With Continuous Thoracic Paravertebral Block and Intravenous Opioid Analgesia for the Postoperative Analgesic Efficacy in Patients Undergoing Modified Radical Mastectomy: A Prospective Randomized Trial.,"OBJECTIVES Postoperative pain following mastectomy is often severe and pain management is necessary. We evaluated the analgesic efficacy of continuous pectoral nerve block (PEC) in comparison with that of the continuous thoracic paravertebral block (TPVB) and the intravenous opioid analgesia in patients scheduled for modified radical mastectomy (MRM). MATERIALS AND METHODS A total of 90 female patients aged 20 to 70 years, American Society of Anesthesiologists (ASA) I to III, undergoing unilateral MRM were randomly allocated into 3 groups. All patients received postoperative morphine patient-controlled analgesia (PCA). Continuous TPVB and continuous PECs were added in group II and group III, respectively. Postoperative morphine consumption during the first 48 hours and postoperative visual analog scale were recorded. RESULTS The cumulative morphine consumption in the first 24 hours postoperative was higher in the PCA-M group (27.47±4.95 mg) than that of the TPVB group (8.43±2.67 mg) and PEC group (13.47±3.89 mg) (P<0.001, confidence interval: 16.6-21.5 and 11.6-16.4, respectively). It was significantly higher in the PEC group as compared with the TPVB group (P<0.001, confidence interval: 2.6-7.5). On admission to postanesthesia care unit till 2 hours postoperative, the median visual analog scale score at rest was higher in the PCA-M group than that of the TPVB group (P<0.05) and PEC group (P<0.05) without statistical difference between the TPVB group and PEC group. DISCUSSION Continuous PEC and continuous TPVB reduced the postoperative morphine consumptions as compared with the intravenous opioid analgesia in patients undergoing MRM with greater reduction in TPVB and without increased adverse effects.",2021,"It was significantly higher in the Pecs group as compared to the TPVB group (P<0.001, CI; 2.6; 7.5).","['patients scheduled for modified radical mastectomy (MRM', 'Patients Undergoing Modified Radical Mastectomy', '90 female patients aged 20 - 70 years, ASA I-III, undergoing unilateral MRM']","['postoperative morphine patient-controlled analgesia (PCA', 'TPVB', 'Continuous Pectoral Nerve Block Compared with Continuous Thoracic Paravertebral Block and Intravenous Opioid Analgesia', 'continuous pectoral nerve block (Pecs', 'continuous thoracic paravertebral block (TPVB', 'opioid analgesia']","['postoperative visual analog scale', 'Postoperative morphine consumption', 'adverse effects', 'analgesic efficacy', 'median VAS score', 'cumulative morphine consumption']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0030131', 'cui_str': 'p-Chloramphetamine'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205967', 'cui_str': 'Pectoral Nerves'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",90.0,0.0737063,"It was significantly higher in the Pecs group as compared to the TPVB group (P<0.001, CI; 2.6; 7.5).","[{'ForeName': 'Mohamed M', 'Initials': 'MM', 'LastName': 'Abu Elyazed', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Shaimaa F', 'Initials': 'SF', 'LastName': 'Mostafa', 'Affiliation': ''}]",The Clinical journal of pain,['10.1097/AJP.0000000000000932'] 2489,33597289,Efficacy and Safety of Bimagrumab in Sporadic Inclusion Body Myositis: Long-term Extension of RESILIENT.,"OBJECTIVE To assess long-term (2 years) effects of bimagrumab in participants with sporadic inclusion body myositis (sIBM). METHODS Participants (aged 36-85 years) who completed the core study (RESILIENT [Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients]) were invited to join an extension study. Individuals continued on the same treatment as in the core study (10 mg/kg, 3 mg/kg, 1 mg/kg bimagrumab or matching placebo administered as IV infusions every 4 weeks). The co-primary outcome measures were 6-minute walk distance (6MWD) and safety. RESULTS Between November 2015 and February 2017, 211 participants entered double-blind placebo-controlled period of the extension study. Mean change in 6MWD from baseline was highly variable across treatment groups, but indicated progressive deterioration from weeks 24-104 in all treatment groups. Overall, 91.0% (n = 142) of participants in the pooled bimagrumab group and 89.1% (n = 49) in the placebo group had ≥1 treatment-emergent adverse event (AE). Falls were slightly higher in the bimagrumab 3 mg/kg group vs 10 mg/kg, 1 mg/kg, and placebo groups (69.2% [n = 36 of 52] vs 56.6% [n = 30 of 53], 58.8% [n = 30 of 51], and 61.8% [n = 34 of 55], respectively). The most frequently reported AEs in the pooled bimagrumab group were diarrhea 14.7% (n = 23), involuntary muscle contractions 9.6% (n = 15), and rash 5.1% (n = 8). Incidence of serious AEs was comparable between the pooled bimagrumab and the placebo group (18.6% [n = 29] vs 14.5% [n = 8], respectively). CONCLUSION Extended treatment with bimagrumab up to 2 years produced a good safety profile and was well-tolerated, but did not provide clinical benefits in terms of improvement in mobility. The extension study was terminated early due to core study not meeting its primary endpoint. CLINICAL TRIAL REGISTRATION Clinicaltrials.gov identifier NCT02573467. CLASSIFICATION OF EVIDENCE This study provides Class IV evidence that for patients with sIBM, long-term treatment with bimagrumab was safe, well-tolerated, and did not provide meaningful functional benefit. The study is rated Class IV because of the open-label design of extension treatment period 2.",2021,"Incidence of serious AEs was comparable between the pooled bimagrumab and the placebo group (18.6% [n = 29] vs 14.5% [n = 8], respectively). ","['participants with sporadic inclusion body myositis', 'patients with sIBM', 'Sporadic Inclusion Body', 'Between November 2015 and February 2017', 'Participants (aged 36-85 years) who completed the core study (RESILIENT) were invited to join an extension study', '211 participants entered double-blind placebo-controlled period of the extension study']","['Bimagrumab', 'bimagrumab', 'bimagrumab, or matching placebo', 'placebo']","['progressive deterioration', 'Mean change in 6MWD', '6-minute walk distance (6MWD) and safety', 'Incidence of serious AEs', 'involuntary muscle contractions', 'Falls', '≥1 treatment-emergent adverse event (AE', 'Efficacy and Safety']","[{'cui': 'C0751713', 'cui_str': 'Myopathy, Inclusion Body, Sporadic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205422', 'cui_str': 'Sporadic'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3899948', 'cui_str': 'bimagrumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0235086', 'cui_str': 'Involuntary muscle contraction'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",142.0,0.638796,"Incidence of serious AEs was comparable between the pooled bimagrumab and the placebo group (18.6% [n = 29] vs 14.5% [n = 8], respectively). ","[{'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Amato', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL. aamato@bwh.harvard.edu.""}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Hanna', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Pedro M', 'Initials': 'PM', 'LastName': 'Machado', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Umesh A', 'Initials': 'UA', 'LastName': 'Badrising', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Chinoy', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Benveniste', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Ananda Krishna', 'Initials': 'AK', 'LastName': 'Karanam', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'László B', 'Initials': 'LB', 'LastName': 'Tankó', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Agnes Annette', 'Initials': 'AA', 'LastName': 'Schubert-Tennigkeit', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Dimitris A', 'Initials': 'DA', 'LastName': 'Papanicolaou', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Lloyd', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Merrilee', 'Initials': 'M', 'LastName': 'Needham', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Liang', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Katrina A', 'Initials': 'KA', 'LastName': 'Reardon', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'de Visser', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Dana P', 'Initials': 'DP', 'LastName': 'Ascherman', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Barohn', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Mazen M', 'Initials': 'MM', 'LastName': 'Dimachkie', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'James A L', 'Initials': 'JAL', 'LastName': 'Miller', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Kissel', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Oskarsson', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Nanette C', 'Initials': 'NC', 'LastName': 'Joyce', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Van den Bergh', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Baets', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Jan L', 'Initials': 'JL', 'LastName': 'De Bleecker', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Chafic', 'Initials': 'C', 'LastName': 'Karam', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'David', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Mirabella', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Sharon P', 'Initials': 'SP', 'LastName': 'Nations', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Hans H', 'Initials': 'HH', 'LastName': 'Jung', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Pegoraro', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Maggi', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Carmelo', 'Initials': 'C', 'LastName': 'Rodolico', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Filosto', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Aziz I', 'Initials': 'AI', 'LastName': 'Shaibani', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Kumaraswamy', 'Initials': 'K', 'LastName': 'Sivakumar', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Namita A', 'Initials': 'NA', 'LastName': 'Goyal', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Madoka', 'Initials': 'M', 'LastName': 'Mori-Yoshimura', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yamashita', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Suzuki', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Aoki', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Masahisa', 'Initials': 'M', 'LastName': 'Katsuno', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Morihata', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Kenya', 'Initials': 'K', 'LastName': 'Murata', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Nodera', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Ichizo', 'Initials': 'I', 'LastName': 'Nishino', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Carla D', 'Initials': 'CD', 'LastName': 'Romano', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Valerie S L', 'Initials': 'VSL', 'LastName': 'Williams', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Vissing', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': 'Lixin', 'Initials': 'L', 'LastName': 'Zhang Auberson', 'Affiliation': ""From the Department of Neurology (A.A.A.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Medical Research Council Centre for Neuromuscular Diseases (M.G.H., P.M.M.) and Institute of Neurology, Department of Neuromuscular Diseases & Centre for Rheumatology (P.M.M.), University College London; Department of Rheumatology & Queen Square Centre for Neuromuscular Diseases (P.M.M.), University College London Hospitals NHS Foundation Trust; Department of Rheumatology (P.M.M.), Northwick Park Hospital, London North West University Healthcare NHS Trust, UK; Department of Neurology (U.A.B.), Leiden University Medical Center, Netherlands; National Institute for Health Research Manchester Biomedical Research Centre (H.C.), Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, UK; Department of Internal Medicine and Clinical Immunology (O.B.), Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France; Novartis Healthcare Pvt. Ltd. (K.A.K), Hyderabad, India; Novartis Pharmaceuticals (M.W., D.A.P.), East Hanover, NJ; Novartis Pharma AG (L.B.T., A.A.S-T.), Basel, Switzerland; Department of Neurology (T.E.L.), The Johns Hopkins University School of Medicine, Baltimore, MD; Institute for Immunology & Infectious Diseases (M.N.), Fiona Stanley Hospital, Murdoch University and Notre Dame University, Perth; Department of Neurology (C.L.), Royal North Shore Hospital, New South Wales; Calvary Health Care Bethlehem (K.A.R.), Caulfield South, Australia; Department of Neurology (M.d.V), Amsterdam University Medical Centre, the Netherlands; Department of Medicine (D.P.A.), University of Miami, FL; Department of Neurology (R.J.B., M.M.D.), University of Kansas Medical Center, Kansas City; Department of Neurology (J.A.L.M.), Newcastle upon Tyne Hospitals NHS Foundation Trust, UK; Department of Neurology (J.T.K.), The Ohio State University Wexner Medical Center, Columbus; Neuromuscular Research Center (B.O., N.C.J.), UC Davis School of Medicine, Sacramento, CA; Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels; Neuromuscular Reference Centre, Department of Neurology (J.B.), Antwerp University Hospital; Institute Born-Bunge (J.B.), University of Antwerp; Department of Neurology (J.L.d.B.), Ghent University Hospital, Belgium; Department of Neurology (C.K.), Oregon Health & Science University, Portland; Department of Neurology (W.S.D.), Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston; Department of Neurology (M.M.), Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Università Cattolica del Sacro Cuore (M.M.), Rome, Italy; Department of Neurology (S.P.N.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (H.H.J.), University Hospital and University of Zurich, Switzerland; Department of Neurosciences (E.P.), University of Padova School of Medicine; Fondazione IRCCS Istituto Neurologico Carlo Besta (L.M.), Milan; Unit of Neurology and Neuromuscular Disorders (C.R.), Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina; Center for Neuromuscular Diseases (M.F.), Unit of Neurology, ASST Spedali Civili and University of Brescia, Italy; Nerve and Muscle Center of Texas (A.I.S.), Houston; Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of Neurology (N.A.G.), ALS & Neuromuscular Center, University of California Irvine, Orange; Department of Neurology (M.M.-Y.), National Center Hospital, National Center of Neurology and Psychiatry, Tokyo; Department of Neurology (S.Y.), Kumamoto University Hospital; Department of Neurology (N.S.), Tohoku University Hospital, Miyagi; Department of Neurology (M.A.), Tohoku University School of Medicine, Sendai; Department of Neurology (M.K.), Nagoya University Hospital, Aichi; Department of Neurology (H.M.), Osaka City General Hospital; Wakayama Medical University Hospital (K.M.); Tokushima University Hospital (H.N.); Department of Neuromuscular Research (I.N.), National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan; RTI Health Solutions (C.D.R., V.S.L.W.), Research Triangle Park, NC; Copenhagen Neuromuscular Center (J.V.), Rigshospitalet, University of Copenhagen, Denmark; and UCB (L.Z.A.), Bulle, Switzerland. H.N. is currently affiliated with the Department of Neurology, Kanazawa Medical University, Ishikawa, Japan. B.O. is currently affiliated with the Department of Neurology, Mayo Clinic, Jacksonville, FL.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology,['10.1212/WNL.0000000000011626'] 2490,33715648,Spirulina supplementation during gradual weight loss in competitive wrestlers.,"We aimed to assess the effects of spirulina supplementation during gradual weight loss on serum concentrations of follistatin (FST), myostatin (MST), insulin-like growth factor 1 (IGF-1), aspartate aminotransferase (AST), alanine aminotransferase (ALT) and body composition in competitive wrestlers. Forty competitive wrestlers (age: 22 (sem 2) years) were randomly assigned to one of two groups: gradual weight loss + spirulina (SP; n 20) or gradual weight loss + placebo (PL; n 20). Subjects in both groups lost weight according to a designed diet over 12 d and were required to reduce baseline body mass (BM) by 4%. Subjects in the SP group received two tablets of spirulina, while subjects in the PL received two tablets of placebo before each meal. Concentrations of mentioned serum markers and body composition were measured before and after the interventions. BM (SP = -3·1 kg and PL = -2·9 kg), body fat percentage (BFP) (SP = -2·1 % and PL = -0·6 %), fat mass (FM) (SP = -2·2 kg and PL = -0·9 kg) and skeletal muscle mass (SP = -1·4 kg and PL = -1·5 kg) significantly decreased in both groups (P < 0·05). The changes in BFP and FM were significantly greater in SP compared with the PL group (P < 0·001). Additionally, MST (SP = -0·1 ng/ml), AST (SP = -2·1 u/l) and ALT (SP = -2·7 u/l) concentrations significantly diminished in SP group (P = 0·005), while FST (PL = -0·1 ng/ml) and IGF-1 (PL = -2·6 ng/ml) concentrations significantly decreased in PL group (P < 0·05). Spirulina supplementation during gradual weight loss is beneficial in reducing BFP, FM, MST and liver enzymes while maintaining IGF-1 and FST concentrations in competitive wrestlers.",2021,The changes in body fat percentage and fat mass were significantly greater in SP compared to the PL group (P<0.001).,['Forty competitive wrestlers (age: 22 ± 2 years'],"['spirulina supplementation', 'MST', 'gradual weight loss + spirulina (SP; n=20) or gradual weight loss + placebo', 'placebo', 'Spirulina supplementation']","['body fat percentage and fat mass', 'body fat percentage', 'serum concentrations of follistatin (FST), myostatin (MST), insulin-like growth factor 1 (IGF-1), aspartate aminotransferase (AST), alanine aminotransferase (ALT), and body composition in competitive wrestlers', 'fat mass', 'skeletal muscle mass', 'Body mass', 'IGF-1', 'Concentrations of mentioned serum markers and body composition']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0075026', 'cui_str': 'Spirulina'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0538238', 'cui_str': 'GDF8 protein, human'}, {'cui': 'C0439833', 'cui_str': 'Gradual'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0060623', 'cui_str': 'Activin-Binding Protein'}, {'cui': 'C0538238', 'cui_str': 'GDF8 protein, human'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0162491', 'cui_str': 'Marker, Serum'}]",40.0,0.0273331,The changes in body fat percentage and fat mass were significantly greater in SP compared to the PL group (P<0.001).,"[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Department of Exercise Physiology, University of Isfahan, Isfahan, Iran.'}, {'ForeName': 'Raoof', 'Initials': 'R', 'LastName': 'Negaresh', 'Affiliation': 'Department of Physical Education & Sport Sciences, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Mohamad S', 'Initials': 'MS', 'LastName': 'Motevalli', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Health and Human Performance, Marymount University, Arlington, VA, USA.'}, {'ForeName': 'Damoon', 'Initials': 'D', 'LastName': 'Ashtary-Larky', 'Affiliation': 'Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Kargarfard', 'Affiliation': 'Department of Exercise Physiology, University of Isfahan, Isfahan, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Rashidlamir', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran.'}]",The British journal of nutrition,['10.1017/S000711452100091X'] 2491,33705695,"Secondary cytoreduction followed by chemotherapy versus chemotherapy alone in platinum-sensitive relapsed ovarian cancer (SOC-1): a multicentre, open-label, randomised, phase 3 trial.","BACKGROUND The benefits of secondary cytoreduction for platinum-sensitive relapsed ovarian cancer are still widely debated. We aimed to assess the efficacy of secondary cytoreduction plus chemotherapy versus chemotherapy alone in this patient population. METHODS This multicentre, open-label, randomised, controlled, phase 3 trial (SOC-1), was done in four primarily academic centres in China (two in Shanghai, one in Hangzhou, and one in Guangzhou). Eligible patients were women aged 18 years and older with platinum-sensitive relapsed epithelial ovarian cancer with a platinum-free interval of at least 6 months after the end of first-line platinum-based chemotherapy and were predicted to have potentially resectable disease according to the international model (iMODEL) score and PET-CT imaging. iMODEL score was calculated using six variables: International Federation of Gynecology and Obstetrics stage, residual disease after primary surgery, platinum-free interval, Eastern Cooperative Oncology Group performance status, serum level of cancer antigen 125 at recurrence, and presence of ascites at recurrence. An iMODEL score of 4·7 or lower predicted a potentially complete resection. As per a protocol amendment, patients with an iMODEL score of more than 4·7 could only be included if the serum level of cancer antigen 125 was more than 105 U/mL, but the principal investigators assessed the disease to be resectable by PET-CT. Eligible participants were randomly assigned (1:1) via a permuted block design (block size of six) and stratified by study centre, iMODEL score, residual disease at primary surgery, and enrolment in the Shanghai Gynecologic Oncology Group SUNNY trial, to undergo secondary cytoreductive surgery followed by intravenous chemotherapy (six 3-weekly cycles of intravenous paclitaxel [175 mg/m 2 ] or docetaxel [75 mg/m 2 ] combined with intravenous carboplatin [area under the curve of 5 mg/mL per min]; surgery group) or intravenous chemotherapy alone (no surgery group). Primary endpoints were progression-free survival and overall survival, analysed in all participants randomly assigned to treatment, regardless of treatment received (intention-to-treat [ITT] population). Here, we report the final analysis of progression-free survival and the prespecified interim analysis of overall survival. Safety was assessed in all participants who received their assigned treatment and had available adverse event data. This study is registered with ClinicalTrials.gov, NCT01611766, and is ongoing but closed to accrual. FINDINGS Between July 19, 2012, and June 3, 2019, 357 patients were recruited and randomly assigned to the surgery group (182) or the no surgery group (175; ITT population). Median follow-up was 36·0 months (IQR 18·1-58·3). In the no surgery group, 11 (6%) of 175 participants had secondary cytoreduction during second-line therapy while 48 (37%) of 130 participants who had disease progression crossed-over and had surgery at a subsequent recurrence. Median progression-free survival was 17·4 months (95% CI 15·0-19·8) in the surgery group and 11·9 months (10·0-13·8) in the no surgery group (hazard ratio [HR] 0·58; 95% CI 0·45-0·74; p<0·0001). At the interim overall survival analysis, median overall survival was 58·1 months (95% CI not estimable to not estimable) in the surgery group and 53·9 months (42·2-65·5) in the no surgery group (HR 0·82, 95% CI 0·57-1·19). In the safety population, nine (5%) of 172 patients in the surgery group had grade 3-4 surgical morbidity at 30 days, and no patients in either group had died at 60 days after receiving assigned treatment. The most common grade 3-4 adverse events during chemotherapy were neutropenia (29 [17%] of 166 patients in the surgery group vs 19 [12%] of 156 patients in the no surgery group), leucopenia (14 [8%] vs eight [5%]), and anaemia (ten [6%] vs nine [6%]). Four serious adverse events occurred, all in the surgery group. No treatment-related deaths occurred in either group. INTERPRETATION Secondary cytoreduction followed by chemotherapy was associated with significantly longer progression-free survival than was chemotherapy alone in patients with platinum-sensitive relapsed ovarian cancer, and patients should be counselled about the option of secondary cytoreduction in specialised centres. Long-term survival outcomes will be assessed using mature data on overall survival. FUNDING Zhongshan Development Program. TRANSLATION For the Chinese translation of the abstract see Supplementary Materials section.",2021,"Primary endpoints were progression-free survival and overall survival, analysed in all participants randomly assigned to treatment, regardless of treatment received (intention-to-treat [ITT] population).","['participants who received their assigned treatment and had available adverse event data', 'four primarily academic centres in China (two in Shanghai, one in Hangzhou, and one in Guangzhou', 'patients with an iMODEL score of more than 4·7 could only be included if the', 'Eligible patients were women aged 18 years and older with platinum-sensitive relapsed epithelial ovarian cancer with a platinum-free interval of at least 6 months after the end of first-line platinum-based chemotherapy and were predicted to have potentially resectable disease according to the international model (iMODEL) score and PET-CT imaging', 'in platinum-sensitive relapsed ovarian cancer (SOC-1', 'Between July 19, 2012, and June 3, 2019, 357 patients were recruited and randomly assigned to the surgery group (182) or the no surgery group (175; ITT population', 'Eligible participants']","['chemotherapy versus chemotherapy alone', 'secondary cytoreductive surgery followed by intravenous chemotherapy (six 3-weekly cycles of intravenous paclitaxel [175 mg/m 2 ] or docetaxel [75 mg/m 2 ] combined with intravenous carboplatin [area under the curve of 5 mg/mL per min]; surgery group) or intravenous chemotherapy alone (no surgery group', 'secondary cytoreduction plus chemotherapy']","['serum level of cancer antigen', 'Median progression-free survival', 'grade 3-4 surgical morbidity', 'anaemia', 'longer progression-free survival', 'leucopenia', 'serum level of cancer antigen 125 at recurrence, and presence of ascites at recurrence', 'progression-free survival and overall survival', 'Safety', 'overall survival analysis, median overall survival', 'secondary cytoreduction', 'neutropenia', 'deaths']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1699633', 'cui_str': 'Positron emission tomography with computed tomography'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0413365', 'cui_str': 'Intravenous chemotherapy'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0006610', 'cui_str': 'Cancer antigen 125'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",357.0,0.739777,"Primary endpoints were progression-free survival and overall survival, analysed in all participants randomly assigned to treatment, regardless of treatment received (intention-to-treat [ITT] population).","[{'ForeName': 'Tingyan', 'Initials': 'T', 'LastName': 'Shi', 'Affiliation': 'Ovarian Cancer Program, Department of Gynaecologic Oncology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jianqing', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of Gynaecologic Oncology, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China.'}, {'ForeName': 'Yanling', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Department of Gynaecologic Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Sun Yat-sen University Cancer Centre, Guangzhou, China.'}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Tu', 'Affiliation': ""Department of Mathematics and Statistics, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Yuqin', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Ovarian Cancer Program, Department of Gynaecologic Oncology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Gynaecologic Oncology, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China.'}, {'ForeName': 'Huixun', 'Initials': 'H', 'LastName': 'Jia', 'Affiliation': 'Clinical Statistics Centre, Shanghai General Hospital, Shanghai, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Department of Gynaecologic Oncology, Fudan University Cancer Hospital, Shanghai, China.'}, {'ForeName': 'Yunlang', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': 'Department of Obstetrics and Gynaecology, Zhongda Hospital Southeast University, Nanjing, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Yin', 'Affiliation': 'Ovarian Cancer Program, Department of Gynaecologic Oncology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Jiang', 'Affiliation': 'Ovarian Cancer Program, Department of Gynaecologic Oncology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Wenjuan', 'Initials': 'W', 'LastName': 'Tian', 'Affiliation': 'Department of Gynaecologic Oncology, Fudan University Cancer Hospital, Shanghai, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': 'Department of Gynaecologic Oncology, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Gynaecologic Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Sun Yat-sen University Cancer Centre, Guangzhou, China.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Gynaecologic Oncology, Fudan University Cancer Hospital, Shanghai, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': 'Department of Gynaecologic Oncology, Fudan University Cancer Hospital, Shanghai, China.'}, {'ForeName': 'Rongyu', 'Initials': 'R', 'LastName': 'Zang', 'Affiliation': 'Ovarian Cancer Program, Department of Gynaecologic Oncology, Zhongshan Hospital, Fudan University, Shanghai, China. Electronic address: zang.rongyu@zs-hospital.sh.cn.'}]",The Lancet. Oncology,['10.1016/S1470-2045(21)00006-1'] 2492,33724534,Serum Glial Fibrillary Acidic Protein: A Neuromyelitis Optica Spectrum Disorder Biomarker.,"OBJECTIVE Blood tests to monitor disease activity, attack severity, or treatment impact in neuromyelitis optica spectrum disorder (NMOSD) have not been developed. This study investigated the relationship between serum glial fibrillary acidic protein (sGFAP) concentration and NMOSD activity and assessed the impact of inebilizumab treatment. METHODS N-MOmentum was a prospective, multicenter, double-blind, placebo-controlled, randomized clinical trial in adults with NMOSD. sGFAP levels were measured by single-molecule arrays (SIMOA) in 1,260 serial and attack-related samples from 215 N-MOmentum participants (92% aquaporin 4-immunoglobulin G-seropositive) and in control samples (from healthy donors and patients with relapsing-remitting multiple sclerosis). RESULTS At baseline, 62 participants (29%) exhibited high sGFAP concentrations (≥170 pg/ml; ≥2 standard deviations above healthy donor mean concentration) and were more likely to experience an adjudicated attack than participants with lower baseline concentrations (hazard ratio [95% confidence interval], 3.09 [1.6-6.1], p = 0.001). Median (interquartile range [IQR]) concentrations increased within 1 week of an attack (baseline: 168.4, IQR = 128.9-449.7 pg/ml; attack: 2,160.1, IQR = 302.7-9,455.0 pg/ml, p = 0.0015) and correlated with attack severity (median fold change from baseline [FC], minor attacks: 1.06, IQR = 0.9-7.4; major attacks: 34.32, IQR = 8.7-107.5, p = 0.023). This attack-related increase in sGFAP occurred primarily in placebo-treated participants (FC: 20.2, IQR = 4.4-98.3, p = 0.001) and was not observed in inebilizumab-treated participants (FC: 1.1, IQR = 0.8-24.6, p > 0.05). Five participants (28%) with elevated baseline sGFAP reported neurological symptoms leading to nonadjudicated attack assessments. INTERPRETATION Serum GFAP may serve as a biomarker of NMOSD activity, attack risk, and treatment effects. ANN NEUROL 2021;89:895-910.",2021,This attack-related increase in sGFAP occurred primarily in placebo-treated participants (FC: 20.2 [4.4-98.3]; p = ,"['neuromyelitis optica spectrum disorder (NMOSD', 'adults with NMOSD']",['placebo'],"['Median (interquartile range [IQR]) concentrations', 'sGFAP', 'sGFAP concentrations', 'attack severity', 'serum glial fibrillary acidic protein (sGFAP) concentration and NMOSD activity', 'sGFAP levels']","[{'cui': 'C0027873', 'cui_str': 'Neuromyelitis optica'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0017626', 'cui_str': 'Glial fibrillary acidic protein'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0027873', 'cui_str': 'Neuromyelitis optica'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",1260.0,0.360435,This attack-related increase in sGFAP occurred primarily in placebo-treated participants (FC: 20.2 [4.4-98.3]; p = ,"[{'ForeName': 'Orhan', 'Initials': 'O', 'LastName': 'Aktas', 'Affiliation': 'Medical Faculty, Heinrich Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Smith', 'Affiliation': 'Viela Bio, Gaithersburg, MD.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Rees', 'Affiliation': 'Viela Bio, Gaithersburg, MD.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Bennett', 'Affiliation': 'School of Medicine, Anschutz Medical Campus, University of Colorado, Aurora, CO.'}, {'ForeName': 'Dewei', 'Initials': 'D', 'LastName': 'She', 'Affiliation': 'Viela Bio, Gaithersburg, MD.'}, {'ForeName': 'Eliezer', 'Initials': 'E', 'LastName': 'Katz', 'Affiliation': 'Viela Bio, Gaithersburg, MD.'}, {'ForeName': 'Bruce A C', 'Initials': 'BAC', 'LastName': 'Cree', 'Affiliation': 'Department of Neurology, UCSF Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of neurology,['10.1002/ana.26067'] 2493,33722585,Effectiveness of the quadrivalent high-dose influenza vaccine for prevention of cardiovascular and respiratory events in people aged 65 years and above: Rationale and design of a real-world pragmatic randomized clinical trial.,"BACKGROUND Influenza has been an acknowledged cause of respiratory disease for decades. However, considerable related, and often unappreciated, disease burden stems from cardiovascular complications, exacerbations of underlying medical conditions and secondary respiratory complications, with the highest burden in the elderly. This novel study combines the gold standard method of a randomized controlled trial with real-world data collection through national registries, to assess the relative effectiveness of high-dose (QIV-HD) vs standard-dose quadrivalent influenza vaccine (QIV-SD) in preventing cardio-respiratory hospitalizations in a large cohort of adults aged ≥65 years. METHODS AND RESULTS This trial (NCT04137887) is a Phase III/IV, modified double-blinded, randomized, registry-based trial, conducted by the Finnish Institute for Health and Welfare (THL). Participants (n>120 000) are being enrolled over multiple influenza seasons and randomized (1:1) to receive QIV-HD or QIV-SD. Participant follow-up is based on data collection up to 11 months post-vaccination using Finnish national health registries. The primary objective is to demonstrate the relative superior effectiveness of QIV-HD over QIV-SD in preventing cardio-respiratory hospitalizations up to 6 months post-vaccination. Safety will be assessed using automated online tools throughout the study, with causality assessed using statistical and probabilistic methods; serious adverse reactions and adverse events of special interest will be investigated individually. CONCLUSION This large, real-world, randomized study will provide valuable insight into the contribution of influenza in causing severe cardio-respiratory events, and the role of vaccination with QIV-HD in reducing these outcomes compared to the current standard of care. FUNDING Sanofi Pasteur.",2021,The primary objective is to demonstrate the relative superior effectiveness of QIV-HD over QIV-SD in preventing cardio-respiratory hospitalizations up to 6 months post-vaccination.,"['people aged 65 years and above', 'Participants (n>120\xa0000) are being enrolled over multiple influenza seasons and randomized (1:1) to receive', 'adults aged ≥65 years', 'Finnish Institute for Health and Welfare (THL']","['QIV-HD or QIV-SD', 'high-dose (QIV-HD) versus standard-dose quadrivalent influenza vaccine (QIV-SD', 'QIV-HD over QIV-SD', 'quadrivalent high-dose influenza vaccine']",['cardiovascular and respiratory events'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0016134', 'cui_str': 'Finnish language'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037440', 'cui_str': 'Social services'}]","[{'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4318638', 'cui_str': 'Quadrivalent Influenza Vaccine'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1320717', 'cui_str': 'Respiratory event'}]",,0.388375,The primary objective is to demonstrate the relative superior effectiveness of QIV-HD over QIV-SD in preventing cardio-respiratory hospitalizations up to 6 months post-vaccination.,"[{'ForeName': 'Rosalind', 'Initials': 'R', 'LastName': 'Hollingsworth', 'Affiliation': 'Global Medical Affairs, Sanofi Pasteur, Swiftwater, PA.'}, {'ForeName': 'Arto', 'Initials': 'A', 'LastName': 'Palmu', 'Affiliation': 'Finnish Institute for Health and Welfare, Tampere, Finland.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Pepin', 'Affiliation': ""Global Clinical Sciences, Sanofi Pasteur, Marcy L'Etoile, France. Electronic address: stephanie.pepin@sanofipasteur.com.""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Dupuy', 'Affiliation': ""Biostatistics Sciences, Sanofi Pasteur, Marcy L'Etoile, France.""}, {'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Shrestha', 'Affiliation': 'Global Pharmacovigilance, Sanofi Pasteur, Swiftwater, PA.'}, {'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Jokinen', 'Affiliation': 'Finnish Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Ritva', 'Initials': 'R', 'LastName': 'Syrjänen', 'Affiliation': 'Finnish Institute for Health and Welfare, Tampere, Finland.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Nealon', 'Affiliation': 'Vaccines Epidemiology and Modelling, Sanofi Pasteur, Lyon, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Samson', 'Affiliation': 'Global Medical Affairs, Sanofi Pasteur, Swiftwater, PA.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'De Bruijn', 'Affiliation': ""Global Clinical Sciences, Sanofi Pasteur, Marcy L'Etoile, France.""}]",American heart journal,['10.1016/j.ahj.2021.03.007'] 2494,33729038,The Impact of Social Support on Treatment Participation and Completion in a Disability Prevention Intervention for Older Adults.,"Objectives: This study evaluates the role of emotional and instrumental social support on treatment participation and completion using the Positive Minds-Strong Bodies (PMSB) disability prevention program. Methods: Data from a multisite randomized controlled trial of the PMSB program for older adults (≥60 years) with physical impairment and mild to severe depression and/or anxiety were used. Participants were randomly assigned to receive 10 sessions of cognitive behavior therapy (CBT) plus 36 sessions of group exercise or usual care. Results: Adjusting for covariates, higher levels of emotional social support at baseline were associated with increased odds of completing the recommended number of CBT sessions (6 or more, OR = 2.58, p = .030), attending 5.56 more exercise sessions ( p = .006), and increased odds of completing the recommended exercise sessions (25 or more, OR = 2.37, p = .047). Discussion: Emotional social support appears to increase dosage in a disability prevention program.",2021,"Results: Adjusting for covariates, higher levels of emotional social support at baseline were associated with increased odds of completing the recommended number of CBT sessions (6 or more, OR = 2.58, p = .030), attending 5.56 more exercise sessions ( p = .006), and increased odds of completing the recommended exercise sessions (25 or more, OR = 2.37, p = .047). ","['older adults (≥60\xa0years) with physical impairment and mild to severe depression and/or anxiety were used', 'Older Adults']","['cognitive behavior therapy (CBT) plus 36 sessions of group exercise or usual care', 'Social Support', 'PMSB program']","['odds of completing the recommended exercise sessions', 'levels of emotional social support']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231171', 'cui_str': 'Physical impairment'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0588008', 'cui_str': 'Severe depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0037438', 'cui_str': 'Social support'}]",,0.0204608,"Results: Adjusting for covariates, higher levels of emotional social support at baseline were associated with increased odds of completing the recommended number of CBT sessions (6 or more, OR = 2.58, p = .030), attending 5.56 more exercise sessions ( p = .006), and increased odds of completing the recommended exercise sessions (25 or more, OR = 2.37, p = .047). ","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Vásquez', 'Affiliation': 'Department of Epidemiology & Biostatistics, School of Public Health, University at Albany (SUNY), Rensselaer, NY, USA.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': ""O'Malley"", 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Cruz-Gonzalez', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Velásquez', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital, Harvard T. H. Chan School of Public Health, Boston, MA, USA.""}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Alegría', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA.'}]",Journal of aging and health,['10.1177/0898264321999897'] 2495,33706003,"Bupropion for postpartum smoking relapse: A remote protocol for a two-arm, double-blind, placebo-controlled randomized clinical trial.","Cigarette smoking among postpartum women remains a significant public health problem despite known health risks to women and their newborns. It is estimated that over 50% of women quit smoking during pregnancy but 90% relapse by one year. Safe and effective postpartum relapse prevention strategies are urgently needed. In an attempt to address this deficit, we will investigate the efficacy of bupropion vs. placebo as a smoking relapse prevention aid in postpartum women. The objective of this paper is to detail an approach to investigate bupropion's efficacy for preventing postpartum smoking relapse among women who quit smoking during pregnancy. Specifically, we designed a two-arm, double-blind, placebo-controlled randomized trial testing the efficacy of bupropion vs. placebo as a relapse prevention tool. Mothers of healthy infants who quit smoking while pregnant will be stratified based on current or past history of major depressive disorder or persistent depressive disorder and randomized to receive either active (bupropion XL 300 mg/day) or placebo medication for 12 weeks. To respond to safety concerns associated with participant and staff exposure to COVID-19, we revised our original protocol and present procedures which allow our trial to be conducted entirely remotely. Primary and secondary outcomes will be assessed at weeks 12, 24, 36 and 52 post-randomization. The primary outcome is 7-day point prevalence abstinence at 24 weeks. Results of this work have the potential to positively impact women and their children by promoting lifelong cessation, eliminating secondhand smoke exposure, and modelling of abstinence to children.",2021,"Results of this work have the potential to positively impact women and their children by promoting lifelong cessation, eliminating secondhand smoke exposure, and modelling of abstinence to children.","['postpartum women', 'Mothers of healthy infants who quit smoking while pregnant will be stratified based on current or past history of major depressive disorder or persistent depressive disorder', 'women who quit smoking during pregnancy']","['bupropion vs. placebo', 'Bupropion', 'active (bupropion XL 300\u202fmg/day) or placebo medication', 'placebo']","['postpartum smoking relapse', '7-day point prevalence abstinence']","[{'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1444635', 'cui_str': 'Current or past'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0013415', 'cui_str': 'Dysthymia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]",,0.420768,"Results of this work have the potential to positively impact women and their children by promoting lifelong cessation, eliminating secondhand smoke exposure, and modelling of abstinence to children.","[{'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Allen', 'Affiliation': 'University of Minnesota, Department of Family Medicine and Community Health, 516 Delaware Street SE, Minneapolis, MN 55455, USA. Electronic address: allen001@umn.edu.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Thomas', 'Affiliation': 'University of Minnesota, Department of Medicine, Division of General Internal Medicine, Program in Health Disparities Research, 717 Delaware Street, SE, Suite 166, Minneapolis, MN 55414, USA. Electronic address: jthomas@umn.edu.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Harrison', 'Affiliation': 'University of Minnesota, Department of Family Medicine and Community Health, 717 Delaware Street SE, Minneapolis, MN 55455, USA. Electronic address: harr0644@umn.edu.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Emery', 'Affiliation': 'University of Minnesota School of Public Health, Division of Epidemiology and Community Health, 300 West Bank Office Building, Minneapolis, MN 55455, USA. Electronic address: emery049@umn.edu.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Petersen', 'Affiliation': 'University of Minnesota School of Public Health, Division of Biostatistics, 420 Delaware St SE, Minneapolis, MN 55455, USA. Electronic address: pete6459@umn.edu.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Winickoff', 'Affiliation': 'MassGeneral Hospital for Children, Division of General Pediatrics, 125 Nashua Street, Boston, MA 02114, USA. Electronic address: jwinickoff@mgh.harvard.edu.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Japuntich', 'Affiliation': 'Hennepin Healthcare, Department of Clinical Pharmacology and Toxicology, University of Minnesota Medical School, Department of Medicine, 701 Park Ave. S.9.303, Minneapolis, MN 55415, USA. Electronic address: Sandra.Jupuntich@hcmed.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106352'] 2496,33707304,"Type 2 Diabetes Subgroups, Risk for Complications, and Differential Effects Due to an Intensive Lifestyle Intervention.","OBJECTIVE We reevaluated the Action for Health in Diabetes (Look AHEAD) intervention, incorporating diabetes subgroups, to identify whether intensive lifestyle intervention (ILI) is associated with differential risk for cardiovascular disease (CVD) by diabetes subgroup. RESEARCH DESIGN AND METHODS In the Look AHEAD trial, 5,145 participants, aged 45-76 years, with type 2 diabetes (T2D) and overweight or obesity were randomly assigned to 10 years of ILI or a control condition of diabetes support and education. The ILI focused on weight loss through decreased caloric intake and increased physical activity. To characterize diabetes subgroups, we applied k-means clustering to data on age of diabetes diagnosis, BMI, waist circumference, and glycated hemoglobin. We examined whether relative intervention effects on the trial's prespecified CVD outcomes varied among diabetes subgroups. RESULTS We characterized four subgroups related to older age at diabetes onset (42% of sample), poor glucose control (14%), severe obesity (24%), and younger age at diabetes onset (20%). We observed interactions (all P < 0.05) between intervention and diabetes subgroups for three separate composite cardiovascular outcomes. Randomization to ILI was associated with increased risk for each cardiovascular outcome only among the poor-glucose-control subgroup (hazard ratio >1.32). Among the three other diabetes subgroups, ILI was not associated with increased risk for CVD. CONCLUSIONS Among overweight and obese adults with T2D, a lifestyle intervention was associated with differential risk for CVD that was dependent on diabetes subgroup. Diabetes subgroups may be important to identify the patients who would achieve benefit and avoid harm from an ILI.",2021,Randomization to ILI was associated with increased risk for each cardiovascular outcome only among the poor-glucose-control subgroup (hazard ratio >1.32).,"['overweight and obese adults with T2D', '5,145 participants, aged 45-76 years, with type 2 diabetes (T2D) and overweight or obesity', 'four subgroups related to older age at diabetes onset (42% of sample), poor glucose control (14%), severe obesity (24%), and younger age at diabetes onset (20']","['intensive lifestyle intervention (ILI', 'ILI or a control condition of diabetes support and education']",['physical activity'],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]",5145.0,0.0394919,Randomization to ILI was associated with increased risk for each cardiovascular outcome only among the poor-glucose-control subgroup (hazard ratio >1.32).,"[{'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Bancks', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, NC mbancks@wakehealth.edu.'}, {'ForeName': 'Haiying', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Balasubramanyam', 'Affiliation': 'Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Alain G', 'Initials': 'AG', 'LastName': 'Bertoni', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Espeland', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': 'VA Puget Sound Health Care System and University of Washington, Seattle, WA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Pilla', 'Affiliation': 'Johns Hopkins School of Medicine, Baltimore, MD.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Vaughan', 'Affiliation': 'Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Lynne E', 'Initials': 'LE', 'LastName': 'Wagenknecht', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc20-2372'] 2497,33724101,Methodology of the fatigue after stroke educational recovery group randomized controlled trial.,"RATIONALE Post-stroke fatigue affects up to 92% of stroke survivors, causing significant burden. Educational cognitive behavioral therapy fatigue groups show positive results in other health conditions. AIMS FASTER will determine if educational cognitive behavioral therapy fatigue management group reduces subjective fatigue in adults post-stroke. DESIGN Prospective, multi-centre, two-arm, single-blind, phase III RCT (parallel, superiority design), with blinded assessments at baseline, six weeks, and three months post-program commencement. With n  = 200 (100 per group, 20% drop-out), the trial will have 85% power (2-sided, p  = 0.05) to detect minimally clinically important differences of 0.60 (SD = 1.27) in fatigue severity scale and 1.70 points (SD = 3.6) in multidimensional fatigue inventory-20 at three months. OUTCOMES Primary outcomes are self-reported fatigue severity and dimensionality (i.e. types of fatigue experienced - physical, psychological and/or cognitive) post-intervention (six weeks). Secondary outcomes include subjective fatigue at three months, and health-related quality of life, disability, sleep, pain, mood, service use/costs, and caregiver burden at each follow-up. DISCUSSION FASTER will determine whether fatigue management group reduces fatigue post-stroke.Registered with the Australian New Zealand Clinical Trials Registry (ACTRN12619000626167).",2021,"Secondary outcomes include subjective fatigue at 3-months, and health-related quality of life, disability, sleep, pain, mood, service use/costs, and caregiver burden at each follow-up. ",['adults post-stroke'],"['educational CBT Fatigue Management Group (FMG', 'FMG', 'Educational Cognitive Behavioural Therapy (CBT']","['subjective fatigue', 'subjective fatigue at 3-months, and health-related quality of life, disability, sleep, pain, mood, service use/costs, and caregiver burden at each follow-up', 'Fatigue severity scale', 'self-reported fatigue severity and dimensionality (i.e., types of fatigue experienced - physical, psychological and/or cognitive']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0851283', 'cui_str': 'Management of fatigue'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]",,0.345656,"Secondary outcomes include subjective fatigue at 3-months, and health-related quality of life, disability, sleep, pain, mood, service use/costs, and caregiver burden at each follow-up. ","[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Barker-Collo', 'Affiliation': 'School of Psychology, University of Auckland, New Zealand.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Krishnamurthi', 'Affiliation': 'National Institute for Stroke and Applied Neurosciences, 1410Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Takayoshi', 'Initials': 'T', 'LastName': 'Ikeda', 'Affiliation': 'National Institute for Stroke and Applied Neurosciences, 1410Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Braden', 'Initials': 'B', 'LastName': 'TeAo', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Geoff', 'Initials': 'G', 'LastName': 'Green', 'Affiliation': 'Services for Older People, Counties Manukau District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Yogini', 'Initials': 'Y', 'LastName': 'Ratnasabapathy', 'Affiliation': 'Older Adults Health and Stroke, 1406Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Sulekha', 'Initials': 'S', 'LastName': 'DeSilva', 'Affiliation': 'National Institute for Stroke and Applied Neurosciences, 1410Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Valery', 'Initials': 'V', 'LastName': 'Feigin', 'Affiliation': 'National Institute for Stroke and Applied Neurosciences, 1410Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Jones', 'Affiliation': 'National Institute for Stroke and Applied Neurosciences, 1410Auckland University of Technology, Auckland, New Zealand.'}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/17474930211006295'] 2498,33721611,"Safety and efficacy of first-line dacomitinib in Asian patients with EGFR mutation-positive non-small cell lung cancer: Results from a randomized, open-label, phase 3 trial (ARCHER 1050).","OBJECTIVES To compare efficacy and safety of dacomitinib versus gefitinib as first-line therapy for EGFR mutation-positive advanced NSCLC in Asian patients enrolled in the ongoing ARCHER 1050 trial. MATERIALS AND METHODS In this ongoing, randomized, open-label, phase 3 trial (NCT01774721), eligible patients with newly diagnosed advanced EGFR mutation-positive NSCLC were randomized (1:1) to receive oral dacomitinib 45 mg/day or oral gefitinib 250 mg/day. Randomization, by a central computer system, was stratified by race and EGFR mutation type (exon 19 deletion mutation/exon 21 L858R substitution mutation). The primary endpoint was PFS by blinded independent review. RESULTS Of 346 Asian patients, 170 were randomized to dacomitinib and 176 to gefitinib. The hazard ratio (HR) for PFS with dacomitinib versus gefitinib was 0.509 (95 % confidence interval [CI]: 0.391-0.662; 1-sided p < 0.0001; median 16.5 months [95 % CI: 12.9-18.4] vs. 9.3 months [95 % CI: 9.2-11.0]). HR for OS with dacomitinib versus gefitinib was 0.759 (95 % CI: 0.578-0.996; median 37.7 months [95 % CI: 30.2-44.7] vs. 29.1 months [95 % CI: 25.6-36.0]). The OS benefit was still maintained in those patients who had a stepwise dose reduction of dacomitinib (to 30 and 15 mg/day). The most common adverse events (AEs) were diarrhea (154 [90.6 %] patients), paronychia (110 [64.7 %]), dermatitis acneiform (96 [56.5 %]), and stomatitis (87 [51.2 %]) with dacomitinib, and diarrhea (100 [56.8 %]), alanine aminotransferase increased (81 [46.0 %]), and aspartate aminotransferase increased (75 [42.6 %]) with gefitinib. Treatment-related serious AEs were reported in 16 (9.4 %) and 8 (4.5 %) patients treated with dacomitinib and gefitinib, respectively. CONCLUSION First-line dacomitinib was associated with significant prolongation of PFS and improved OS compared with gefitinib in Asian patients with EGFR mutation-positive advanced NSCLC. The AE profiles of dacomitinib and gefitinib in Asian patients were consistent with the overall ARCHER 1050 population.",2021,The hazard ratio (HR) for PFS with dacomitinib versus gefitinib was 0.509,"['346 Asian patients, 170 were randomized to dacomitinib and 176 to gefitinib', 'Asian patients', 'EGFR mutation-positive advanced NSCLC in Asian patients enrolled in the ongoing ARCHER 1050 trial', 'eligible patients with newly diagnosed advanced EGFR mutation-positive NSCLC', 'Asian patients with EGFR mutation-positive non-small cell lung cancer', 'Asian patients with EGFR mutation-positive advanced NSCLC']","['oral dacomitinib 45 mg/day or oral gefitinib', 'first-line dacomitinib', 'gefitinib', 'dacomitinib versus gefitinib']","['prolongation of PFS and improved OS', 'dermatitis acneiform', 'OS benefit', 'hazard ratio (HR', 'Safety and efficacy', 'paronychia', 'diarrhea', 'alanine aminotransferase', 'aspartate aminotransferase']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C2987430', 'cui_str': 'dacomitinib'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C4517528', 'cui_str': '1050'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4731604', 'cui_str': 'dacomitinib 45 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C2987430', 'cui_str': 'dacomitinib'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0234894', 'cui_str': 'Dermatitis acneiform'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030578', 'cui_str': 'Paronychia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}]",346.0,0.26581,The hazard ratio (HR) for PFS with dacomitinib versus gefitinib was 0.509,"[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Jilin Provincial Cancer Hospital, Changchun, China.'}, {'ForeName': 'Tony S', 'Initials': 'TS', 'LastName': 'Mok', 'Affiliation': 'State Key Laboratory of Translational Oncology, Department of Clinical Oncology, Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Xiangdong', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'First Affiliated Hospital of Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China.""}, {'ForeName': 'Jianying', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'First Affiliated Hospital of Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Yu', 'Affiliation': 'Sichuan Cancer Hospital, Chengdu, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Lung Cancer, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Chengping', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Department of Respiratory Medicine, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Thoracic Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Ki Hyeong', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, South Korea.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Kindai University Hospital, Osaka, Japan.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Linke', 'Affiliation': 'SFJ Pharmaceuticals Inc., Pleasanton, CA, USA.'}, {'ForeName': 'Chew Hooi', 'Initials': 'CH', 'LastName': 'Wong', 'Affiliation': 'Pfizer Pte. Ltd., Singapore.'}, {'ForeName': 'Yiyun', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Pfizer Oncology, La Jolla, CA, USA.'}, {'ForeName': 'Fanfan', 'Initials': 'F', 'LastName': 'Zhu', 'Affiliation': 'Pfizer Investment Co., Ltd., Shanghai, China.'}, {'ForeName': 'Keith D', 'Initials': 'KD', 'LastName': 'Wilner', 'Affiliation': 'Pfizer Inc., San Diego, CA, USA.'}, {'ForeName': 'Yi-Long', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China. Electronic address: syylwu@live.cn.""}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2021.02.025'] 2499,33721562,"Pembrolizumab versus brentuximab vedotin in relapsed or refractory classical Hodgkin lymphoma (KEYNOTE-204): an interim analysis of a multicentre, randomised, open-label, phase 3 study.","BACKGROUND PD-1 blockade via pembrolizumab monotherapy has shown antitumour activity and toxicity in patients with relapsed or refractory classical Hodgkin lymphoma. Here, we present interim analyses from the KEYNOTE-204 study evaluating pembrolizumab versus brentuximab vedotin for relapsed or refractory classical Hodgkin lymphoma. METHODS In this randomised, open-label, phase 3 study, patients aged 18 years or older with relapsed or refractory classical Hodgkin lymphoma with measurable disease and an Eastern Cooperative Oncology Group performance status of 0 or 1 who were ineligible for or had relapsed after autologous haematopoietic stem-cell transplantation (HSCT) were enrolled at 78 hospitals and cancer centres in 20 countries and territories. Patients were randomly assigned (1:1) with an interactive voice response system to pembrolizumab 200 mg intravenously every 3 weeks or brentuximab vedotin 1·8 mg/kg intravenously every 3 weeks. Randomisation was stratified by previous autologous HSCT and status after front-line therapy. Results from the second interim analysis are presented here, with a database cutoff of Jan 16, 2020. The dual primary endpoints assessed in the intention-to-treat population were progression-free survival as assessed by blinded independent central review, and overall survival (not analysed at this interim analysis). Safety was assessed in all patients who received at least one dose of the study drug. This study is registered with ClinicalTrials.gov, NCT02684292. Recruitment for this trial is closed. FINDINGS Between July 8, 2016, and July 13, 2018, 151 patients were randomly assigned to pembrolizumab and 153 to brentuximab vedotin. After a median time from randomisation to data cutoff of 25·7 months (IQR 23·4-33·0), median progression-free survival was 13·2 months (95% CI 10·9-19·4) for pembrolizumab versus 8·3 months (5·7-8·8) for brentuximab vedotin (hazard ratio 0·65 [95% CI 0·48-0·88]; p=0·0027). The most common grade 3-5 treatment-related adverse events were pneumonitis (six [4%] of 148 patients in the pembrolizumab group vs one [1%] of 152 patients in the brentuximab vedotin group), neutropenia (three [2%] vs 11 [7%]), decreased neutrophil count (one [1%] vs seven [5%]), and peripheral neuropathy (one [1%] vs five [3%]). Serious treatment-related adverse events occurred in 24 (16%) of 148 patients receiving pembrolizumab and 16 (11%) of 152 patients receiving brentuximab vedotin. One treatment-related death due to pneumonia occurred in the pembrolizumab group. INTERPRETATION Pembrolizumab showed statistically significant and clinically meaningful improvement in progression-free survival compared with brentuximab vedotin, with safety consistent with previous reports. These data support pembrolizumab as the preferred treatment option for patients with relapsed or refractory classical Hodgkin lymphoma who have relapsed post-autologous HSCT or are ineligible for autologous HSCT. FUNDING Merck Sharp & Dohme Corp (a subsidiary of Merck & Co, Inc, Kenilworth, NJ, USA).",2021,Serious treatment-related adverse events occurred in 24 (16%) of 148 patients receiving pembrolizumab and 16 (11%) of 152 patients receiving brentuximab vedotin.,"['148 patients receiving', 'Between July 8, 2016, and July 13, 2018, 151 patients', 'patients with relapsed or refractory classical Hodgkin lymphoma', 'patients with relapsed or refractory classical Hodgkin lymphoma who have relapsed post-autologous HSCT or are ineligible for autologous HSCT', 'patients aged 18 years or older with relapsed or refractory classical Hodgkin lymphoma with measurable disease and an Eastern Cooperative Oncology Group performance status of 0 or 1 who were ineligible for or had relapsed after autologous haematopoietic stem-cell transplantation (HSCT) were enrolled at 78 hospitals and cancer centres in 20 countries and territories', 'for relapsed or refractory classical Hodgkin lymphoma']","['Pembrolizumab versus brentuximab vedotin', 'pembrolizumab and 153 to brentuximab vedotin', 'pembrolizumab monotherapy', 'pembrolizumab', 'interactive voice response system to pembrolizumab 200 mg intravenously every 3 weeks or brentuximab vedotin 1·8 mg/kg intravenously every 3 weeks', 'pembrolizumab versus brentuximab vedotin']","['antitumour activity and toxicity', 'median progression-free survival', 'death due to pneumonia', 'adverse events', 'Safety', 'neutropenia', 'progression-free survival', 'decreased neutrophil count', 'peripheral neuropathy', 'intention-to-treat population were progression-free survival as assessed by blinded independent central review, and overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C1333064', 'cui_str': 'Classical Hodgkin lymphoma'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C2973446', 'cui_str': 'brentuximab vedotin'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0853697', 'cui_str': 'Neutropenia'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",151.0,0.368753,Serious treatment-related adverse events occurred in 24 (16%) of 148 patients receiving pembrolizumab and 16 (11%) of 152 patients receiving brentuximab vedotin.,"[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kuruvilla', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, ON, Canada. Electronic address: john.kuruvilla@uhn.ca.'}, {'ForeName': 'Radhakrishnan', 'Initials': 'R', 'LastName': 'Ramchandren', 'Affiliation': 'Department of Medicine, University of Tennessee, Knoxville, TN, USA.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Santoro', 'Affiliation': 'Humanitas University, Department of Biomedical Sciences, Milan, Italy.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Paszkiewicz-Kozik', 'Affiliation': 'Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Gasiorowski', 'Affiliation': 'Concord Hospital, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Nathalie A', 'Initials': 'NA', 'LastName': 'Johnson', 'Affiliation': 'Jewish General Hospital Montreal, Montreal, QC, Canada.'}, {'ForeName': 'Laura Maria', 'Initials': 'LM', 'LastName': 'Fogliatto', 'Affiliation': 'Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Iara', 'Initials': 'I', 'LastName': 'Goncalves', 'Affiliation': 'Fundação Pio XII-Hospital de Câncer de Barretos, São Paulo, Brazil.'}, {'ForeName': 'Jose S R', 'Initials': 'JSR', 'LastName': 'de Oliveira', 'Affiliation': 'Casa de Saude Santa Marcelina, São Paulo, Brazil.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Buccheri', 'Affiliation': 'Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Guilherme F', 'Initials': 'GF', 'LastName': 'Perini', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Neta', 'Initials': 'N', 'LastName': 'Goldschmidt', 'Affiliation': 'Hadassah Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Kriachok', 'Affiliation': 'National Cancer Institute, Kiev, Ukraine.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dickinson', 'Affiliation': 'Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Mieczyslaw', 'Initials': 'M', 'LastName': 'Komarnicki', 'Affiliation': 'Szpital Kliniczny im Przemienienia, Poznań, Poland.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McDonald', 'Affiliation': 'Pretoria East Hospital, Pretoria, South Africa.'}, {'ForeName': 'Muhit', 'Initials': 'M', 'LastName': 'Ozcan', 'Affiliation': 'Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Naohiro', 'Initials': 'N', 'LastName': 'Sekiguchi', 'Affiliation': 'Department of Hematology, National Hospital Organization Disaster Medical Center, Tokyo, Japan.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Concord Hospital, Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Akash', 'Initials': 'A', 'LastName': 'Nahar', 'Affiliation': 'Concord Hospital, Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Marinello', 'Affiliation': 'Concord Hospital, Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Pier Luigi', 'Initials': 'PL', 'LastName': 'Zinzani', 'Affiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy; Istituto di Ematologia ""Seràgnoli"", Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Università di Bologna, Bologna, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(21)00005-X'] 2500,33726855,Optimising medication management in children and young people with ADHD using a computerised test (QbTest): a feasibility randomised controlled trial.,"BACKGROUND Medication for attention deficit hyperactivity disorder (ADHD) should be closely monitored to ensure optimisation. There is growing interest in using computerised assessments of ADHD symptoms to support medication monitoring. The aim of this study was to assess the feasibility and acceptability of a randomised controlled trial (RCT) to evaluate the efficacy of one such computerised assessment, the Quantified Behavior (Qb) Test, as part of medication management for ADHD. METHODS This feasibility multi-site RCT conducted in child and adolescent mental health and community paediatric settings recruited participants aged 6-15 years diagnosed with ADHD starting stimulant medication. Participants were randomised into one of two arms: experimental (QbTest protocol) where participants completed a QbTest at baseline and two follow-up QbTests on medication (2-4 weeks and 8-10 weeks later) and control where participants received treatment as usual, including at least two follow-up consultations. Measures of parent, teacher, and clinician-rated symptoms and global functioning were completed at each time point. Clinicians recorded treatment decision-making and health economic measures were obtained. Data were analysed using multi-level modelling and participants (children and parents) and clinicians were interviewed about their experiences, resulting data were thematically analysed. RESULTS Forty-four children and young people were randomised. Completion of study outcome measures by care-givers and teachers ranged from 52 to 78% at baseline to 47-65% at follow-up. Participants reported the questionnaires to be useful to complete. SNAP-IV inattention scores showed greater reduction in the intervention than the control group (- 5.85, 95% CI - 10.33, - 1.36,). Engagement with the intervention ranged from 100% at baseline, to 78% follow-up 1 and 57% follow-up 2. However, only 37% of QbTests were conducted in the correct time period. Interview data highlighted that the objectivity of the QbTest was appreciated by clinicians and parents. Clinicians commented that the additional time and resources required meant that it is not feasible to use QbTest for all cases. CONCLUSION The trial design and protocol appear to be feasible and acceptable but could be improved by modifying QbTest time periods and the method of data collection. With these changes, the protocol may be appropriate for a full trial. Adding QbTest may improve symptom outcome as measured by SNAP-IV. TRIAL REGISTRATION ClinicalTrials.gov, NCT03368573 , prospectively registered, 11th December 2017, and ISRCTN, ISRCTN69461593 , retrospectively registered, 10th April 2018.",2021,"SNAP-IV inattention scores showed greater reduction in the intervention than the control group (- 5.85, 95% CI - 10.33, - 1.36,).","['Forty-four children and young people', 'children and young people with ADHD', 'child and adolescent mental health and community paediatric settings recruited participants aged 6-15\u2009years diagnosed with ADHD starting stimulant medication']",['QbTest at baseline and two follow-up QbTests on medication'],"['Measures of parent, teacher, and clinician-rated symptoms and global functioning', 'symptom outcome', 'feasibility and acceptability', 'SNAP-IV inattention scores']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1177045', 'cui_str': 'Snap'}, {'cui': 'C0424101', 'cui_str': 'Inattention'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",44.0,0.423217,"SNAP-IV inattention scores showed greater reduction in the intervention than the control group (- 5.85, 95% CI - 10.33, - 1.36,).","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Williams', 'Affiliation': 'School of Medicine, Division of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK. laura.williams1@nottingham.ac.uk.'}, {'ForeName': 'Charlotte L', 'Initials': 'CL', 'LastName': 'Hall', 'Affiliation': 'School of Medicine, Division of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Brown', 'Affiliation': 'School of Medicine, Division of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK.'}, {'ForeName': 'Boliang', 'Initials': 'B', 'LastName': 'Guo', 'Affiliation': 'School of Medicine, Division of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'James', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Matilde', 'Initials': 'M', 'LastName': 'Franceschini', 'Affiliation': 'Division of Rehabilitation and Ageing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Clarke', 'Affiliation': 'United Lincolnshire Hospitals NHS Trust, Grantham and District Hospital, Grantham, Lincolnshire, UK.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Selby', 'Affiliation': 'Department of Community Paediatrics, Medway NHS Foundation Trust, Kent, UK.'}, {'ForeName': 'Hena', 'Initials': 'H', 'LastName': 'Vijayan', 'Affiliation': 'North East London NHS Foundation Trust, Havering CAMHS, Essex, UK.'}, {'ForeName': 'Neeta', 'Initials': 'N', 'LastName': 'Kulkarni', 'Affiliation': 'Leicestershire Partnership NHS Trust, Leicester, UK.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Brown', 'Affiliation': 'School of Medicine, Division of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK.'}, {'ForeName': 'Kapil', 'Initials': 'K', 'LastName': 'Sayal', 'Affiliation': 'School of Medicine, Division of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Hollis', 'Affiliation': 'School of Medicine, Division of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK.'}, {'ForeName': 'Madeleine J', 'Initials': 'MJ', 'LastName': 'Groom', 'Affiliation': 'School of Medicine, Division of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK.'}]",Pilot and feasibility studies,['10.1186/s40814-021-00788-1'] 2501,33726834,"A randomized, placebo-controlled experimental medicine study of RIPK1 inhibitor GSK2982772 in patients with moderate to severe rheumatoid arthritis.","BACKGROUND Receptor-interacting protein kinase 1 (RIPK1) is a key mediator of inflammation through cell death and proinflammatory cytokine production. This multicenter, randomized, double-blind (sponsor-unblinded), placebo-controlled, experimental medicine study evaluated the safety, pharmacokinetics (PK), and preliminary efficacy of GSK2982772, a RIPK1 inhibitor, in moderate to severe rheumatoid arthritis (RA). METHODS Patients with moderate to severe RA who had received ≥12 weeks' stable-dose conventional synthetic disease-modifying antirheumatic drug (csDMARD) therapy were randomized (2:1) to GSK2982772 60 mg or placebo orally 2 or 3 times daily for 84 days. Safety, PK, disease activity, joint damage, and pharmacodynamic (PD) biomarkers were assessed at days 43 and 85. RESULTS A total of 52 patients were randomized (placebo, 18; GSK2982772, 34). Adverse events (AEs) were reported in 13 (72%) in patients in the placebo group (n = 3 b.i.d; n = 10 t.i.d.) and 20 (61%) in the GSK2982772 group (n = 3 b.i.d; n = 17 t.i.d.). All treatment-related AEs were mild/moderate, except one severe case of alopecia areata at day 49 and retinal vein thrombosis at day 66 (which led to withdrawal from the study) in patients receiving GSK2982772 t.i.d. Disease Activity Score in 28 Joints-C-reactive protein (DAS28-CRP) scores, ACR20/50/70 response, and rates of low disease activity and remission were similar between placebo and GSK2982772 arms. CONCLUSIONS These results suggest that inhibition of RIPK1 activity at the GSK2982772 exposure levels evaluated do not translate into meaningful clinical improvement of RA. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02858492 . Registered 8 August 2016.",2021,"All treatment-related AEs were mild/moderate, except one severe case of alopecia areata at day 49 and retinal vein thrombosis at day 66 (which led to withdrawal from the study) in patients receiving GSK2982772 t.i.d.","[""Patients with moderate to severe RA who had received ≥12\u2009weeks' stable-dose conventional synthetic disease-modifying antirheumatic drug "", 'A total of 52 patients', 'patients with moderate to severe rheumatoid arthritis']","['placebo', 'RIPK1 inhibitor GSK2982772']","['RIPK1 activity', 'retinal vein thrombosis', 'safety, pharmacokinetics (PK', 'Safety, PK, disease activity, joint damage, and pharmacodynamic (PD) biomarkers', 'Disease Activity Score in 28 Joints-C-reactive protein (DAS28-CRP) scores, ACR20/50/70 response, and rates of low disease activity and remission', 'Adverse events (AEs', 'alopecia areata']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0297981', 'cui_str': 'RIPK1 protein, human'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0297981', 'cui_str': 'RIPK1 protein, human'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0035328', 'cui_str': 'Retinal vein occlusion'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}]",52.0,0.522451,"All treatment-related AEs were mild/moderate, except one severe case of alopecia areata at day 49 and retinal vein thrombosis at day 66 (which led to withdrawal from the study) in patients receiving GSK2982772 t.i.d.","[{'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Weisel', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Berger', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Thorn', 'Affiliation': 'GlaxoSmithKline, Stockley Park, Uxbridge, UK.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Taylor', 'Affiliation': 'Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Peterfy', 'Affiliation': 'Spire Sciences, Inc., Boca Raton, FL, USA.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Siddall', 'Affiliation': 'GlaxoSmithKline Medicine Research Center, Gunnels Wood Road, Stevenage, Hertfordshire, SG1 2NY, UK. hilary.x.siddall@gsk.com.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Tompson', 'Affiliation': 'GlaxoSmithKline Medicine Research Center, Gunnels Wood Road, Stevenage, Hertfordshire, SG1 2NY, UK.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Quattrocchi', 'Affiliation': 'GlaxoSmithKline, Stockley Park, Uxbridge, UK.'}, {'ForeName': 'Susan W', 'Initials': 'SW', 'LastName': 'Burriss', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Walter', 'Affiliation': 'Rheumatologische Schwerpunktpraxis, Rendsburg, Germany.'}, {'ForeName': 'Paul Peter', 'Initials': 'PP', 'LastName': 'Tak', 'Affiliation': 'GlaxoSmithKline Medicine Research Center, Gunnels Wood Road, Stevenage, Hertfordshire, SG1 2NY, UK.'}]",Arthritis research & therapy,['10.1186/s13075-021-02468-0'] 2502,33729674,Maternal postpartum deworming and infant milk intake: Secondary outcomes from a trial.,"The World Health Organization recommends deworming to reduce soil-transmitted helminth (STH)-attributable morbidity in women of reproductive age, including pregnant and lactating women, to reduce blood loss, iron deficiency anaemia and nutrient malabsorption. This study assessed the impact of maternal postpartum deworming with albendazole approximately 1 day after delivery on infant milk intake among a subset of 216 randomly selected mother-infant pairs recruited into a large trial in Peru. Infant milk intake was measured using the deuterium-oxide method at 1- and 6-month postpartum. Maternal STH infection was measured at 6-month postpartum. At 1-month postpartum, mean intake was 756 ± 16 and 774 ± 18 mL day -1 in the albendazole and placebo groups, respectively (mean difference: -18 mL day -1 ; 95% CI: -65, 30). At 6-month postpartum, mean intake was 903 ± 16 and 908 ± 18 mL day -1 in the albendazole and placebo groups, respectively (mean difference: -5 mL day -1 ; 95% CI: -52, 43). There was no statistically significant difference in milk intake between groups at either time point. At 6-month postpartum, mothers infected with Trichuris trichiura had infants with higher milk intakes (adjusted mean difference: 70 mL day -1 ; 95% CI: 20, 120) compared with uninfected mothers. However, there was no statistically significant difference in infant milk intake between mothers who had moderate-and-heavy intensity infection compared with the comparison group (mothers with no and light intensity infection). A lower prevalence and intensity of infection, and inclusion of uninfected mothers in both arms of the trial, resulting in effect dilution, may explain the null findings.",2021,"However, there was no statistically significant difference in infant milk intake between mothers who had moderate-and-heavy intensity infection compared with the comparison group (mothers with no and light intensity infection).","['women of reproductive age, including pregnant and lactating women', 'infant milk intake among a subset of 216 randomly selected mother-infant pairs recruited into a large trial in Peru']","['albendazole', 'albendazole and placebo', 'placebo', 'Maternal postpartum deworming and infant milk intake']","['Maternal STH infection', 'milk intake', 'Infant milk intake', 'infant milk intake', 'higher milk intakes']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0556184', 'cui_str': 'Baby milk intake'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0031238', 'cui_str': 'Peru'}]","[{'cui': 'C0001911', 'cui_str': 'Albendazole'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0199859', 'cui_str': 'Deworming'}, {'cui': 'C0556184', 'cui_str': 'Baby milk intake'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0037592', 'cui_str': 'Soil'}, {'cui': 'C0018889', 'cui_str': 'Helminth infection'}, {'cui': 'C0556180', 'cui_str': 'Milk intake'}, {'cui': 'C0556184', 'cui_str': 'Baby milk intake'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.211609,"However, there was no statistically significant difference in infant milk intake between mothers who had moderate-and-heavy intensity infection compared with the comparison group (mothers with no and light intensity infection).","[{'ForeName': 'Layla S', 'Initials': 'LS', 'LastName': 'Mofid', 'Affiliation': 'Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montréal, Québec, Canada.'}, {'ForeName': 'Martín', 'Initials': 'M', 'LastName': 'Casapía', 'Affiliation': 'Asociación Civil Selva Amazónica, Iquitos, Peru.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Montresor', 'Affiliation': 'Department of Control of Neglected Tropical Diseases, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Rahme', 'Affiliation': 'Centre for Outcomes Research and Evaluation, Research Institute of the McGill University Health Centre, Montréal, Québec, Canada.'}, {'ForeName': 'Grace S', 'Initials': 'GS', 'LastName': 'Marquis', 'Affiliation': 'School of Human Nutrition, McGill University, Sainte Anne-de-Bellevue, Québec, Canada.'}, {'ForeName': 'Jozef', 'Initials': 'J', 'LastName': 'Vercruysse', 'Affiliation': 'Department of Virology, Parasitology and Immunology, Faculty of Veterinary Medicine, Ghent University, Merelbeke, Belgium.'}, {'ForeName': 'Lindsay H', 'Initials': 'LH', 'LastName': 'Allen', 'Affiliation': 'USDA, ARS Western Human Nutrition Research Center, University of California, Davis, California, USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Blouin', 'Affiliation': 'Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montréal, Québec, Canada.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Razuri', 'Affiliation': 'Centre for Outcomes Research and Evaluation, Research Institute of the McGill University Health Centre, Montréal, Québec, Canada.'}, {'ForeName': 'Lidsky', 'Initials': 'L', 'LastName': 'Pezo', 'Affiliation': 'Asociación Civil Selva Amazónica, Iquitos, Peru.'}, {'ForeName': 'Theresa W', 'Initials': 'TW', 'LastName': 'Gyorkos', 'Affiliation': 'Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montréal, Québec, Canada.'}]",Maternal & child nutrition,['10.1111/mcn.13183'] 2503,33727509,A comparative study of transdermal nitroglycerine patch and oral nifedipine in preterm labor.,"Background Currently, the main goal for the use of tocolytic therapy is to delay the birth so as to allow the use of corticosteroids for accelerating fetal lung maturity and maternal transfer to a tertiary care center and thereby reducing neonatal morbidity and mortality. Aims and Objectives The aims amd objectives were to compare the safety and efficacy of transdermal nitroglycerine patch with oral nifedipine as a tocolytic agent to arrest preterm labor and prevent preterm birth. Materials and Methods Based on the selection criteria, 50 patients were selected randomly in Group A and Group B. Group A women were given transdermal nitroglycerin patch, which delivered 10 mg Nitroglycerin (NTG) over 24 h and it was applied to the woman's abdomen followed by another patch of 10 mg after 1 h if contractions persisted. After 24 h, it was replaced by a fresh patch. Group B women were given an oral loading dose of nifedipine 20 mg followed by a similar dose if contractions persisted after 1 h. A maintenance dose of 10 mg thrice daily was given if contractions were suppressed. Patients were monitored from the time of admission to the time of discharge. Results The mean duration of prolongation of pregnancy in Group B (3.68 ± 1.91 days) was significantly more than Group A (2.78 ± 1.39 days). Headache was seen significantly more in Group A (42%) than group B (6%). Tachycardia, hypotension, and palpitation showed no statistically significant difference between them. There was no statistically significant difference in the birth weight of the babies in both the groups. Conclusion Nifedipine is a safe and effective drug in prolonging preterm labor and has minimal maternal and neonatal side effects.",2021,"Conclusion Nifedipine is a safe and effective drug in prolonging preterm labor and has minimal maternal and neonatal side effects.","['preterm labor', '50 patients']","['transdermal nitroglycerin patch', 'Nifedipine', 'Nitroglycerin (NTG', 'tocolytic therapy', 'transdermal nitroglycerine patch and oral nifedipine', 'transdermal nitroglycerine patch with oral nifedipine', 'nifedipine']","['time of admission to the time of discharge', 'safety and efficacy', 'Headache', 'birth weight of the babies', 'mean duration of prolongation of pregnancy', 'Tachycardia, hypotension, and palpitation']","[{'cui': 'C0022876', 'cui_str': 'Premature labor'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0699222', 'cui_str': 'Nitroglycerin Transdermal System'}, {'cui': 'C0028066', 'cui_str': 'Nifedipine'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C0040348', 'cui_str': 'Tocolysis'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0030252', 'cui_str': 'Palpitations'}]",50.0,0.0298175,"Conclusion Nifedipine is a safe and effective drug in prolonging preterm labor and has minimal maternal and neonatal side effects.","[{'ForeName': 'Prabhleen', 'Initials': 'P', 'LastName': 'Kaur', 'Affiliation': 'Department of Obstetrics and Gynaecology, Government Medical College, Amritsar, Punjab, India.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Madan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Government Medical College, Amritsar, Punjab, India.'}, {'ForeName': 'Sujata', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, Government Medical College, Amritsar, Punjab, India.'}]",Annals of African medicine,['10.4103/aam.aam_11_20'] 2504,33733479,Personalized physical rehabilitation program and employment in kidney transplant recipients: a randomized trial.,"Kidney transplantation is the preferred treatment for kidney failure; however after transplant, reduced physical function, poor self-perceptions, and unemployment are common concerns that remain. This randomized controlled trial compared the effects of a 12-month exercise rehabilitation program (intervention) to standard care alone (control) in kidney transplant recipients. The exercise intervention consisted of a 2 day/week, 60-minute personalized, one-on-one, resistance-based exercise trainings. Eighty participants completed the study (52 intervention vs. 28 control). For individuals unemployed at baseline, there was a 52.3% increase in employment compared to 13.3 % increase in the control group after 12 months (P = <0.0001). For those already employed at baseline, 100% of individuals maintained employment in both groups after 12 months (P = 0.4742). For all comers, there was a positive trend for Global Physical Health (P = 0.0034), Global Mental Health (P = 0.0064), and Physical Function (P = 0.0075), with the intervention group showing greater improvements. These findings suggest the implementation of an exercise rehabilitation program postkidney transplant can be beneficial to increase employment for individuals previously unemployed, improve self-perceived health, physical function, and mental health, overall contributing to better health outcomes in kidney transplant recipients. (Clinicaltrials.gov number: NCT02409901).",2021,"For all comers, there was a positive trend for Global Physical Health (p=0.0034), Global Mental Health (p=0.0064), and Physical Function","['Eighty participants completed the study (52 intervention vs. 28 control', 'kidney transplant recipients']","['12 month exercise rehabilitation program (intervention) to standard care alone (control', '60 minute personalized, one-on-one, resistance based exercise trainings', 'Personalized physical rehabilitation program']","['Physical Function', 'employment', 'Global Physical Health', 'Global Mental Health']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",80.0,0.0172545,"For all comers, there was a positive trend for Global Physical Health (p=0.0034), Global Mental Health (p=0.0064), and Physical Function","[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kastelz', 'Affiliation': 'Department of Surgery, University of Illinois University at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Fernhall', 'Affiliation': 'College of Applied Health Sciences, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Wang', 'Affiliation': 'College of Applied Health Sciences, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Tzvetanov', 'Affiliation': 'Department of Surgery, University of Illinois University at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Spaggiari', 'Affiliation': 'Department of Surgery, University of Illinois University at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Aneesha', 'Initials': 'A', 'LastName': 'Shetty', 'Affiliation': 'Internal Medicine Nephrology, Northwestern Medical Group, Chicago, IL, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Gallon', 'Affiliation': 'Internal Medicine Nephrology, Northwestern Medical Group, Chicago, IL, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Hachaj', 'Affiliation': 'GH FitLab, Chicago, IL, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Kaplan', 'Affiliation': 'Baylor Scott and White Health System, Corporate office, Dallas, TX, USA.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Benedetti', 'Affiliation': 'Department of Surgery, University of Illinois University at Chicago, Chicago, IL, USA.'}]",Transplant international : official journal of the European Society for Organ Transplantation,['10.1111/tri.13868'] 2505,33734299,"Effect of Intermediate-Dose vs Standard-Dose Prophylactic Anticoagulation on Thrombotic Events, Extracorporeal Membrane Oxygenation Treatment, or Mortality Among Patients With COVID-19 Admitted to the Intensive Care Unit: The INSPIRATION Randomized Clinical Trial.","Importance Thrombotic events are commonly reported in critically ill patients with COVID-19. Limited data exist to guide the intensity of antithrombotic prophylaxis. Objective To evaluate the effects of intermediate-dose vs standard-dose prophylactic anticoagulation among patients with COVID-19 admitted to the intensive care unit (ICU). Design, Setting, and Participants Multicenter randomized trial with a 2 × 2 factorial design performed in 10 academic centers in Iran comparing intermediate-dose vs standard-dose prophylactic anticoagulation (first hypothesis) and statin therapy vs matching placebo (second hypothesis; not reported in this article) among adult patients admitted to the ICU with COVID-19. Patients were recruited between July 29, 2020, and November 19, 2020. The final follow-up date for the 30-day primary outcome was December 19, 2020. Interventions Intermediate-dose (enoxaparin, 1 mg/kg daily) (n = 276) vs standard prophylactic anticoagulation (enoxaparin, 40 mg daily) (n = 286), with modification according to body weight and creatinine clearance. The assigned treatments were planned to be continued until completion of 30-day follow-up. Main Outcomes and Measures The primary efficacy outcome was a composite of venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation, or mortality within 30 days, assessed in randomized patients who met the eligibility criteria and received at least 1 dose of the assigned treatment. Prespecified safety outcomes included major bleeding according to the Bleeding Academic Research Consortium (type 3 or 5 definition), powered for noninferiority (a noninferiority margin of 1.8 based on odds ratio), and severe thrombocytopenia (platelet count <20 ×103/µL). All outcomes were blindly adjudicated. Results Among 600 randomized patients, 562 (93.7%) were included in the primary analysis (median [interquartile range] age, 62 [50-71] years; 237 [42.2%] women). The primary efficacy outcome occurred in 126 patients (45.7%) in the intermediate-dose group and 126 patients (44.1%) in the standard-dose prophylaxis group (absolute risk difference, 1.5% [95% CI, -6.6% to 9.8%]; odds ratio, 1.06 [95% CI, 0.76-1.48]; P = .70). Major bleeding occurred in 7 patients (2.5%) in the intermediate-dose group and 4 patients (1.4%) in the standard-dose prophylaxis group (risk difference, 1.1% [1-sided 97.5% CI, -∞ to 3.4%]; odds ratio, 1.83 [1-sided 97.5% CI, 0.00-5.93]), not meeting the noninferiority criteria (P for noninferiority >.99). Severe thrombocytopenia occurred only in patients assigned to the intermediate-dose group (6 vs 0 patients; risk difference, 2.2% [95% CI, 0.4%-3.8%]; P = .01). Conclusions and Relevance Among patients admitted to the ICU with COVID-19, intermediate-dose prophylactic anticoagulation, compared with standard-dose prophylactic anticoagulation, did not result in a significant difference in the primary outcome of a composite of adjudicated venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation, or mortality within 30 days. These results do not support the routine empirical use of intermediate-dose prophylactic anticoagulation in unselected patients admitted to the ICU with COVID-19. Trial Registration ClinicalTrials.gov Identifier: NCT04486508.",2021,"The primary efficacy outcome was a composite of venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation, or mortality within 30 days, assessed in randomized patients who met the eligibility criteria and received at least 1 dose of the assigned treatment.","['patients with COVID-19 admitted to the intensive care unit (ICU', 'unselected patients admitted to the ICU with COVID-19', '600 randomized patients, 562 (93.7%) were included in the primary analysis (median [interquartile range] age, 62 [50-71] years; 237 [42.2%] women', 'Admitted to the Intensive Care Unit', 'adult patients admitted to the ICU with COVID-19', '10 academic centers in Iran comparing', 'critically ill patients with COVID-19', 'Patients With COVID-19', 'Patients were recruited between July 29, 2020, and November 19, 2020']","['Interventions\n\n\nIntermediate-dose (enoxaparin, 1 mg/kg daily', 'standard prophylactic anticoagulation (enoxaparin', 'intermediate-dose vs standard-dose prophylactic anticoagulation', 'intermediate-dose vs standard-dose prophylactic anticoagulation (first hypothesis) and statin therapy vs matching placebo', 'Intermediate-Dose vs Standard-Dose Prophylactic Anticoagulation']","['Major bleeding', 'Severe thrombocytopenia', 'major bleeding according to the Bleeding Academic Research Consortium (type 3 or 5 definition', 'severe thrombocytopenia', 'Thrombotic Events, Extracorporeal Membrane Oxygenation Treatment, or Mortality', 'composite of adjudicated venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation, or mortality', 'composite of venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation, or mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0151942', 'cui_str': 'Arterial thrombosis'}]",600.0,0.529629,"The primary efficacy outcome was a composite of venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation, or mortality within 30 days, assessed in randomized patients who met the eligibility criteria and received at least 1 dose of the assigned treatment.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Parham', 'Initials': 'P', 'LastName': 'Sadeghipour', 'Affiliation': 'Cardiovascular Intervention Research Center, Rajaie Cardiovascular, Medical, and Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Azita H', 'Initials': 'AH', 'LastName': 'Talasaz', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Rashidi', 'Affiliation': 'Tuberclosis and Lung Diseases Research Center, Tabriz, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Sharif-Kashani', 'Affiliation': 'Tobacoo Prevention and control Research center, National Research institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Taghi', 'Initials': 'MT', 'LastName': 'Beigmohammadi', 'Affiliation': 'Anesthesiology and Intensive Care, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Farrokhpour', 'Affiliation': 'Firouzgar hospital, Department of internal medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Hashem', 'Initials': 'SH', 'LastName': 'Sezavar', 'Affiliation': 'Research Center for Prevention of Cardiovascular Disease, Institute of Endocrinology & Metabolism, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pooya', 'Initials': 'P', 'LastName': 'Payandemehr', 'Affiliation': 'Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Dabbagh', 'Affiliation': 'Department of Anesthesiology, School of Medicine Anesthesiology Research Center Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Keivan Gohari', 'Initials': 'KG', 'LastName': 'Moghadam', 'Affiliation': 'School of Medicine, Department of Internal Medicine, Shariati Hospital, Tehran, Iran.'}, {'ForeName': 'Sepehr', 'Initials': 'S', 'LastName': 'Jamalkhani', 'Affiliation': 'Student Research Committee, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Khalili', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Yadollahzadeh', 'Affiliation': 'Firouzgar hospital, Department of internal medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Taghi', 'Initials': 'T', 'LastName': 'Riahi', 'Affiliation': 'Rasoul-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Rezaeifar', 'Affiliation': 'Tuberclosis and Lung Diseases Research Center, Tabriz, Iran.'}, {'ForeName': 'Ouria', 'Initials': 'O', 'LastName': 'Tahamtan', 'Affiliation': 'Tuberclosis and Lung Diseases Research Center, Tabriz, Iran.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Matin', 'Affiliation': 'Tuberclosis and Lung Diseases Research Center, Tabriz, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Abedini', 'Affiliation': 'Chronic Respiratory Disease Research Center, Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Lookzadeh', 'Affiliation': 'Chronic Respiratory Disease Research Center, Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Rahmani', 'Affiliation': 'Department of Pharmacotherapy, Faculty of Pharmacy, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Zoghi', 'Affiliation': 'School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Keyhan', 'Initials': 'K', 'LastName': 'Mohammadi', 'Affiliation': 'School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pardis', 'Initials': 'P', 'LastName': 'Sadeghipour', 'Affiliation': 'Firouzgar hospital, Department of internal medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Homa', 'Initials': 'H', 'LastName': 'Abri', 'Affiliation': 'Firouzgar hospital, Department of internal medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Tabrizi', 'Affiliation': 'Rasoul-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Masoud', 'Initials': 'SM', 'LastName': 'Mousavian', 'Affiliation': 'Rasoul-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shaghayegh', 'Initials': 'S', 'LastName': 'Shahmirzaei', 'Affiliation': 'Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Bakhshandeh', 'Affiliation': 'Clinical Trial Center, Rajaie Cardiovascular, Medical, and Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Amin', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Farnaz', 'Initials': 'F', 'LastName': 'Rafiee', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Baghizadeh', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Bahram', 'Initials': 'B', 'LastName': 'Mohebbi', 'Affiliation': 'Cardiovascular Intervention Research Center, Rajaie Cardiovascular, Medical, and Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Ehsan', 'Initials': 'SE', 'LastName': 'Parhizgar', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Rasoul', 'Initials': 'R', 'LastName': 'Aliannejad', 'Affiliation': 'School of Medicine, Department of Pulmonary and Critical Care, Shariati Hospital, Tehran, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Eslami', 'Affiliation': 'Cardiovascular Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Kashefizadeh', 'Affiliation': 'Shahid Dr Labbafinejad Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hessam', 'Initials': 'H', 'LastName': 'Kakavand', 'Affiliation': 'School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Hossein', 'Initials': 'SH', 'LastName': 'Hosseini', 'Affiliation': 'School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Shafaghi', 'Affiliation': 'Lung Transplantation Research Center, Department of Cardiology, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Samrand Fattah', 'Initials': 'SF', 'LastName': 'Ghazi', 'Affiliation': 'Anesthesiology and Intensive Care, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Atabak', 'Initials': 'A', 'LastName': 'Najafi', 'Affiliation': 'Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jimenez', 'Affiliation': 'Respiratory Department, Hospital Ramón y Cajal (IRYCIS), Madrid, Spain.'}, {'ForeName': 'Aakriti', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Cardiovascular Research Foundation (CRF), New York, New York.'}, {'ForeName': 'Mahesh V', 'Initials': 'MV', 'LastName': 'Madhavan', 'Affiliation': 'Cardiovascular Research Foundation (CRF), New York, New York.'}, {'ForeName': 'Sanjum S', 'Initials': 'SS', 'LastName': 'Sethi', 'Affiliation': 'Cardiovascular Research Foundation (CRF), New York, New York.'}, {'ForeName': 'Sahil A', 'Initials': 'SA', 'LastName': 'Parikh', 'Affiliation': 'Cardiovascular Research Foundation (CRF), New York, New York.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Monreal', 'Affiliation': 'Department of Internal Medicine, Hospital Germans Trias i Pujol, Badalona, Barcelona, Universidad Católica de Murcia, Murcia, Spain.'}, {'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Hadavand', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Hajighasemi', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Maleki', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Sadeghian', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Piazza', 'Affiliation': ""Cardiovascular Medicine Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Ajay J', 'Initials': 'AJ', 'LastName': 'Kirtane', 'Affiliation': 'Cardiovascular Research Foundation (CRF), New York, New York.'}, {'ForeName': 'Benjamin W', 'Initials': 'BW', 'LastName': 'Van Tassell', 'Affiliation': 'School of Pharmacy, Department of Pharmacotherapy and Outcome Science, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Paul P', 'Initials': 'PP', 'LastName': 'Dobesh', 'Affiliation': 'College of Pharmacy, University of Nebraska Medical Center, Omaha.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Cardiovascular Research Foundation (CRF), New York, New York.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom.'}, {'ForeName': 'Harlan M', 'Initials': 'HM', 'LastName': 'Krumholz', 'Affiliation': 'Yale/YNHH Center for Outcomes Research & Evaluation, New Haven, Connecticut.'}, {'ForeName': 'Samuel Z', 'Initials': 'SZ', 'LastName': 'Goldhaber', 'Affiliation': ""Cardiovascular Medicine Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Behnood', 'Initials': 'B', 'LastName': 'Bikdeli', 'Affiliation': 'Cardiovascular Research Foundation (CRF), New York, New York.'}]",JAMA,['10.1001/jama.2021.4152'] 2506,33734289,Effect of Second-generation vs Third-generation Chemotherapy Regimens With Thoracic Radiotherapy on Unresectable Stage III Non-Small-Cell Lung Cancer: 10-Year Follow-up of a WJTOG0105 Phase 3 Randomized Clinical Trial.,"Importance Insufficient data are available regarding the long-term outcomes and cumulative incidences of toxic effects that are associated with chemoradiotherapy (CRT) for patients with stage III non-small-cell lung cancer. Objective To evaluate survival and late toxic effects 10 years after patients were treated with curative CRT. Design, Setting, and Participants This multicenter, phase 3 West Japan Thoracic Oncology Group (WJTOG) 0105 randomized clinical trial was conducted between September 2001 and September 2005 in Japan. Patients with histologically or cytologically confirmed non-small-cell lung cancer with unresectable stage III disease were assessed for eligibility. Additional data were analyzed from January 2018 to December 2019. Interventions A total of 440 eligible patients were randomly assigned to groups as follows: A (control), 4 cycles of mitomycin/vindesine/cisplatin plus thoracic radiotherapy (TRT) of 60 Gy; B, weekly irinotecan/carboplatin for 6 weeks plus TRT of 60 Gy followed by 2 courses of irinotecan/carboplatin consolidation; or C, weekly paclitaxel/carboplatin for 6 weeks plus TRT of 60 Gy followed by 2 courses of paclitaxel/carboplatin consolidation. Main Outcomes and Measures The primary outcome was 10-year survival probability after CRT. The secondary outcome was late toxic effects that occurred more than 90 days after initiating CRT. Results From September 2001 to September 2005, 440 patients (group A, n = 146 [33.2%; median (range) age, 63 (31-74) years; 18 women (12.3%)]; group B, n = 147 [33.4%; median (range) age, 63 (30-75) years; 22 women (15.0%)]; group C, n = 147 [33.4%; median (range) age, 63 (38-74) years; 19 women (12.9%)]) were enrolled. The median (range) follow-up was 11.9 (7.6-13.3) years. In groups A, B, and C, median (range) overall survival times were 20.5 (17.5-26.0), 19.8 (16.7-23.5), and 22.0 (18.7-26.2) months, respectively, and 10-year survival probabilities were 13.6%, 7.5%, and 15.2%, respectively. There were no significant differences in overall survival among treatment groups. The 10-year progression-free survival probabilities were 8.5%, 6.5%, and 11.1% in groups A, B, and C, respectively. Grade 3 or 4 late toxic effect rates were 3.4% (heart, 0.7%; lung, 2.7%) in group A, and those only affecting the lung represented 3.4% and 4.1% in groups B and C, respectively. No other cases of late toxic effects (grades 3/4) were observed since the initial report. Conclusion and Relevance In this 10-year follow-up of a phase 3 randomized clinical trial, group C achieved similar efficacy and toxic effect profiles as group A 10 years after initiating treatment. These results serve as a historical control for the long-term comparisons of outcomes of future clinical trials of CRT. Trial Registration UMIN Clinical Trial Registry: UMIN000030811.",2021,There were no significant differences in overall survival among treatment groups.,"['Unresectable Stage III Non-Small-Cell Lung Cancer', 'Additional data were analyzed from January 2018 to December 2019', 'Results\n\n\nFrom September 2001 to September 2005, 440 patients (group A, n\u2009=\u2009146 [33.2%; median (range) age, 63 (31-74) years; 18 women (12.3%)]; group B, n\u2009=\u2009147 [33.4%; median (range) age, 63 (30-75) years; 22 women (15.0%)]; group C, n\u2009=\u2009147 [33.4%; median (range) age, 63 (38-74) years; 19 women (12.9%)]) were enrolled', 'September 2001 and September 2005 in Japan', 'Patients with histologically or cytologically confirmed non-small-cell lung cancer with unresectable stage III disease', 'patients with stage III non-small-cell lung cancer', '440 eligible patients', '10 years after patients were treated with curative CRT.\nDesign, Setting, and Participants']","['paclitaxel/carboplatin consolidation', 'mitomycin/vindesine/cisplatin plus thoracic radiotherapy (TRT) of 60 Gy; B, weekly irinotecan/carboplatin', 'irinotecan/carboplatin consolidation; or C, weekly paclitaxel/carboplatin', 'Second-generation vs Third-generation Chemotherapy Regimens With Thoracic Radiotherapy', 'chemoradiotherapy (CRT']","['survival and late toxic effects', '10-year progression-free survival probabilities', '10-year survival probabilities', 'Grade 3 or 4 late toxic effect rates', 'late toxic effects', '10-year survival probability', 'overall survival', 'median (range) overall survival times']","[{'cui': 'C0278506', 'cui_str': 'Non-small cell lung cancer stage III'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C5191283', 'cui_str': '12.3'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0042682', 'cui_str': 'Vindesine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}]",440.0,0.500616,There were no significant differences in overall survival among treatment groups.,"[{'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Zenke', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Tsuboi', 'Affiliation': 'Department of Thoracic Surgery, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Yasutaka', 'Initials': 'Y', 'LastName': 'Chiba', 'Affiliation': 'Clinical Research Center, Kindai University Hospital, Osaka, Japan.'}, {'ForeName': 'Kayoko', 'Initials': 'K', 'LastName': 'Tsujino', 'Affiliation': 'Department of Radiation Oncology, Hyogo Cancer Center, Akashi, Hyogo, Japan.'}, {'ForeName': 'Miyako', 'Initials': 'M', 'LastName': 'Satouchi', 'Affiliation': 'Department of Thoracic Oncology, Hyogo Cancer Center, Akashi, Hyogo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Sawa', 'Affiliation': 'Department of Respiratory Medicine, Graduate School of Medicine, Osaka City University, Osaka, Japan.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Shimizu', 'Affiliation': 'Department of Thoracic Oncology, Aichi Cancer Center Hospital, Nagoya, Aichi, Japan.'}, {'ForeName': 'Haruko', 'Initials': 'H', 'LastName': 'Daga', 'Affiliation': 'Department of Medical Oncology, Osaka City General Hospital, Osaka, Japan.'}, {'ForeName': 'Daichi', 'Initials': 'D', 'LastName': 'Fujimoto', 'Affiliation': 'Department of Respiratory Medicine, Kobe City Medical Center General Hospital, Kobe, Japan.'}, {'ForeName': 'Masahide', 'Initials': 'M', 'LastName': 'Mori', 'Affiliation': 'Department of Thoracic Oncology, National Hospital Organization Osaka Toneyama Medical Center, Osaka, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Aoki', 'Affiliation': 'Division of Pulmonary Medicine, Department of Medicine, Tokai University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Sawa', 'Affiliation': 'Division of Respiratory Medicine and Oncology, Gifu Municipal Hospital, Gifu, Japan.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Omori', 'Affiliation': 'Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Saka', 'Affiliation': 'Department of Respiratory Medicine and Medical Oncology, National Hospital Organization Nagoya Medical Center, Aichi, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Iwamoto', 'Affiliation': 'Department of Respiratory Medicine, Hiroshima City Hospital, Hiroshima, Japan.'}, {'ForeName': 'Motoyasu', 'Initials': 'M', 'LastName': 'Okuno', 'Affiliation': 'Department of Respiratory Medicine, Okazaki City Hospital, Okazaki, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Hirashima', 'Affiliation': 'Department of Thoracic Oncology, Osaka Prefectural Hospital Organization Osaka Habikino Medical Center, Osaka, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Kashiwabara', 'Affiliation': 'Department of Respiratory Medicine, Kumamoto Regional Medical Center, Kumamoto, Japan.'}, {'ForeName': 'Motoko', 'Initials': 'M', 'LastName': 'Tachihara', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Ymamoto', 'Affiliation': 'Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan.'}]",JAMA oncology,['10.1001/jamaoncol.2021.0113'] 2507,33734288,Effectiveness of Electroacupuncture or Auricular Acupuncture vs Usual Care for Chronic Musculoskeletal Pain Among Cancer Survivors: The PEACE Randomized Clinical Trial.,"Importance The opioid crisis creates challenges for cancer pain management. Acupuncture confers clinical benefits for chronic nonmalignant pain, but its effectiveness in cancer survivors remains uncertain. Objective To determine the effectiveness of electroacupuncture or auricular acupuncture for chronic musculoskeletal pain in cancer survivors. Design, Setting, and Participants The Personalized Electroacupuncture vs Auricular Acupuncture Comparativeness Effectiveness (PEACE) trial is a randomized clinical trial that was conducted from March 2017 to October 2019 (follow-up completed April 2020) across an urban academic cancer center and 5 suburban sites in New York and New Jersey. Study statisticians were blinded to treatment assignments. The 360 adults included in the study had a prior cancer diagnosis but no current evidence of disease, reported musculoskeletal pain for at least 3 months, and self-reported pain intensity on the Brief Pain Inventory (BPI) ranging from 0 (no pain) to 10 (worst pain imaginable). Interventions Patients were randomized 2:2:1 to electroacupuncture (n = 145), auricular acupuncture (n = 143), or usual care (n = 72). Intervention groups received 10 weekly sessions of electroacupuncture or auricular acupuncture. Ten acupuncture sessions were offered to the usual care group from weeks 12 through 24. Main Outcomes and Measures The primary outcome was change in average pain severity score on the BPI from baseline to week 12. Using a gatekeeping multiple-comparison procedure, electroacupuncture and auricular acupuncture were compared with usual care using a linear mixed model. Noninferiority of auricular acupuncture to electroacupuncture was tested if both interventions were superior to usual care. Results Among 360 cancer survivors (mean [SD] age, 62.1 [12.7] years; mean [SD] baseline BPI score, 5.2 [1.7] points; 251 [69.7%] women; and 88 [24.4%] non-White), 340 (94.4%) completed the primary end point. Compared with usual care, electroacupuncture reduced pain severity by 1.9 points (97.5% CI, 1.4-2.4 points; P < .001) and auricular acupuncture reduced by 1.6 points (97.5% CI, 1.0-2.1 points; P < .001) from baseline to week 12. Noninferiority of auricular acupuncture to electroacupuncture was not demonstrated. Adverse events were mild; 15 of 143 (10.5%) patients receiving auricular acupuncture and 1 of 145 (0.7%) patients receiving electroacupuncture discontinued treatments due to adverse events (P < .001). Conclusions and Relevance In this randomized clinical trial among cancer survivors with chronic musculoskeletal pain, electroacupuncture and auricular acupuncture produced greater pain reduction than usual care. However, auricular acupuncture did not demonstrate noninferiority to electroacupuncture, and patients receiving it had more adverse events. Trial Registration ClinicalTrials.gov Identifier: NCT02979574.",2021,"Compared with usual care, electroacupuncture reduced pain severity by 1.9 points (97.5% CI, 1.4-2.4 points; P < .001) and auricular acupuncture reduced by 1.6 points (97.5% CI, 1.0-2.1 points; P < .001) from baseline to week 12.","['360 adults included in the study had a prior cancer diagnosis but no current evidence of disease, reported musculoskeletal pain for at least 3 months, and self-reported pain intensity on the Brief Pain Inventory (BPI) ranging from 0 (no pain) to 10 (worst pain imaginable', 'was conducted from March 2017 to October 2019 (follow-up completed April 2020) across an urban academic cancer center and 5 suburban sites in New York and New Jersey', 'cancer survivors with chronic musculoskeletal pain', 'chronic musculoskeletal pain in cancer survivors', '360 cancer survivors (mean [SD] age', 'Cancer Survivors']","['electroacupuncture or auricular acupuncture', 'Electroacupuncture vs Auricular Acupuncture Comparativeness Effectiveness', 'Acupuncture', 'auricular acupuncture', 'auricular acupuncture to electroacupuncture', 'gatekeeping multiple-comparison procedure, electroacupuncture and auricular acupuncture', 'Electroacupuncture or Auricular Acupuncture vs Usual Care', 'electroacupuncture', 'electroacupuncture and auricular acupuncture']","['Adverse events', 'average pain severity score', 'auricular acupuncture', 'adverse events', 'Chronic Musculoskeletal Pain', 'pain severity', 'pain reduction']","[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0027971', 'cui_str': 'New Jersey'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0752217', 'cui_str': 'Ear Acupuncture'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0752217', 'cui_str': 'Ear Acupuncture'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.534993,"Compared with usual care, electroacupuncture reduced pain severity by 1.9 points (97.5% CI, 1.4-2.4 points; P < .001) and auricular acupuncture reduced by 1.6 points (97.5% CI, 1.0-2.1 points; P < .001) from baseline to week 12.","[{'ForeName': 'Jun J', 'Initials': 'JJ', 'LastName': 'Mao', 'Affiliation': 'Integrative Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Kevin T', 'Initials': 'KT', 'LastName': 'Liou', 'Affiliation': 'Integrative Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Raymond E', 'Initials': 'RE', 'LastName': 'Baser', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Bao', 'Affiliation': 'Integrative Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Katherine S', 'Initials': 'KS', 'LastName': 'Panageas', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Sally A D', 'Initials': 'SAD', 'LastName': 'Romero', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego School of Medicine, San Diego.'}, {'ForeName': 'Q Susan', 'Initials': 'QS', 'LastName': 'Li', 'Affiliation': 'Integrative Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Rollin M', 'Initials': 'RM', 'LastName': 'Gallagher', 'Affiliation': 'Center for Health Equity Research and Promotion, Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Philip W', 'Initials': 'PW', 'LastName': 'Kantoff', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}]",JAMA oncology,['10.1001/jamaoncol.2021.0310'] 2508,33714077,Trajectories of symptoms of anxiety and depression among people on sick leave with mood or anxiety disorders: Secondary analysis from a randomized controlled trial.,"BACKGROUND Depression and anxiety are heterogenous disorders often combined into one entity in studies. Few studies have compared trajectories of depression and anxiety among clinically ill. We aimed to identify specific trajectories of depression, and anxiety and predictors of trajectory membership. METHODS Latent growth mixture modelling was carried out on data from the IPS-MA trial (n = 261), a supported employment intervention for people with mood or anxiety, to identify trajectories of depression and anxiety. Logistic regression was used to estimate predictors for trajectory membership. Associations between trajectory class and remission of comorbid depression or anxiety and return to work were also tested. RESULTS We identified three trajectories of depression and anxiety symptoms respectively; moderate-decreasing (60%), moderate-stable (26%), and low-stable (14%) depression and mild-decreasing (59%), moderate-decreasing (33%), and moderate-stable (8%) anxiety. The depression model showed low precision in class separation (entropy 0.66), hence, predictors of class membership were not estimated. For anxiety, lower age and higher levels of depressive symptoms were associated with a less desirable trajectory. Remission of comorbid depressive symptoms after two years differed significantly between classes (p < 0.000). Fewer had returned to work in the two moderate classes compared to the mild-decreasing anxiety class. LIMITATIONS Depression model not reliable. Only 80% of participants from original study included. Not able to distinguish between anxiety disorders. CONCLUSION Trajectories of anxiety confirm that, even after two years, a rather large proportion in the moderate-stable class had symptoms of moderate anxiety, moderate comorbid depressive symptoms, and less probability of having returned to work. TRIAL REGISTRATION ClinicalTrials.govNCT01721824.",2021,Remission of comorbid depressive symptoms after two years differed significantly between classes (p < 0.000).,"['people on sick leave with mood or anxiety disorders', '26%), and low-stable (14%) depression and mild-decreasing (59%), moderate-decreasing (33%), and moderate-stable (8%) anxiety', 'Latent growth mixture modelling was carried out on data from the IPS-MA trial (n\xa0=\xa0261']",['supported employment intervention'],"['Remission of comorbid depressive symptoms', 'moderate anxiety, moderate comorbid depressive symptoms', 'moderate-stable', 'depressive symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0231402', 'cui_str': 'Moderate anxiety'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",,0.0555192,Remission of comorbid depressive symptoms after two years differed significantly between classes (p < 0.000).,"[{'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Hellström', 'Affiliation': 'CORE: Copenhagen Research Center for Mental Health, Mental Health Centre Copenhagen, Gentofte Hospitalsvej 15, 2900, Hellerup, Denmark. Electronic address: lone.hellstroem@regionh.dk.'}, {'ForeName': 'Trine', 'Initials': 'T', 'LastName': 'Madsen', 'Affiliation': 'CORE: Copenhagen Research Center for Mental Health, Mental Health Centre Copenhagen, Gentofte Hospitalsvej 15, 2900, Hellerup, Denmark.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Nordentoft', 'Affiliation': 'CORE: Copenhagen Research Center for Mental Health, Mental Health Centre Copenhagen, Gentofte Hospitalsvej 15, 2900, Hellerup, Denmark; Department of Clinical Medicine, Faculty of Health Science, University of Copenhagen, Denmark.'}, {'ForeName': 'Lene Falgaard', 'Initials': 'LF', 'LastName': 'Eplov', 'Affiliation': 'CORE: Copenhagen Research Center for Mental Health, Mental Health Centre Copenhagen, Gentofte Hospitalsvej 15, 2900, Hellerup, Denmark.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2021.02.040'] 2509,33735635,Effect of rose oil on Gastroesophageal Reflux Disease in comparison with omeprazole: A double-blind controlled trial.,"BACKGROUND AND OBJECTIVE Gastroesophageal reflux disease (GERD) as one of the most common ailments of gastrointestinal system diminishes quality of life and impairs physical functioning and work productivity. Proton-pump inhibitors (PPIs), such as omeprazole play a more dominant role in amelioration of GERD symptoms; nonetheless, there is a growing concern about their side effects. According to traditional Persian medicine (TPM), the use of rose oil is recommended to alleviate GERD symptoms. MATERIALS AND METHODS Therefore, a randomized double-blind controlled trial was performed on 70 subjects who were randomly enrolled in two groups and received either rose oil softgel or omeprazole capsule combined with the placebo. Data were collected within 3 sessions of visit using the Mayo-gastroesophageal reflux questionnaire (GERQ). RESULTS Although, our findings showed that reflux symptoms were decreased in both groups after receiving medicine and the decrement was significant in treatment group, before and after the intervention, this decrease was not significant between two groups. CONCLUSION Given that the rose oil used in this study was produced according to the Iranian method and effective ingredients of Rosa damascena were preserved in sesame oil in production process, it seems that effectiveness of this product can be due to its tonic and enlivening properties. Consumption of rose oil soft capsule alleviates cardinal GERD symptoms similar to omeprazole. It seems that rose oil can have the same effects as PPIs in treatment of GERD but with no side effects due to its different mechanisms of action.",2021,Consumption of rose oil soft capsule alleviates cardinal GERD symptoms similar to omeprazole.,['70 subjects who were randomly enrolled in two groups and received either'],"['traditional Persian medicine (TPM', 'rose oil', 'Proton-pump inhibitors (PPIs', 'rose oil softgel or omeprazole capsule combined with the placebo', 'omeprazole']","['Mayo-gastroesophageal reflux questionnaire (GERQ', 'reflux symptoms', 'Gastroesophageal Reflux Disease']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0031188', 'cui_str': 'Persian language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0304113', 'cui_str': 'Rose oil'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",70.0,0.0745187,Consumption of rose oil soft capsule alleviates cardinal GERD symptoms similar to omeprazole.,"[{'ForeName': 'Mohammad Sadegh', 'Initials': 'MS', 'LastName': 'Adel Mehraban', 'Affiliation': 'School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: sadeghadel@gmail.com.'}, {'ForeName': 'Meysam', 'Initials': 'M', 'LastName': 'Shirzad', 'Affiliation': 'School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: shirzadmd@gmail.com.'}, {'ForeName': 'Mohammad Mahdi', 'Initials': 'MM', 'LastName': 'Ahmadian-Attari', 'Affiliation': 'Evidence-based Phytotherapy and Complementary Medicine Research Center, Alborz University of Medical Sciences, Karaj, Iran; Department of Pharmacognosy, Faculty of Pharmacy, Alborz University of Medical Sciences, Karaj, Iran. Electronic address: ahmadian.attari@gmail.com.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Shakeri', 'Affiliation': 'Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: rshakeri@gmail.com.'}, {'ForeName': 'Leila Mohamad', 'Initials': 'LM', 'LastName': 'Taghizadeh Kashani', 'Affiliation': 'Department of Traditional Medicine, Medicinal Plants Research Center of Barij, Kashan, Iran. Electronic address: kashanileila138@yahoo.com.'}, {'ForeName': 'Maliheh', 'Initials': 'M', 'LastName': 'Tabarrai', 'Affiliation': 'School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: Dr.mtabarrai@yahoo.com.'}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'Shirbeigi', 'Affiliation': 'School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: l.shirbeigi@yahoo.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101361'] 2510,33730652,Safety of pemetrexed plus platinum in combination with pembrolizumab for metastatic nonsquamous non-small cell lung cancer: A post hoc analysis of KEYNOTE-189.,"OBJECTIVES This post hoc analysis assessed the safety of pemetrexed and platinum in combination with pembrolizumab, including time-to-onset and time-to-resolution of all-cause any-grade and grade ≥3 adverse events (AEs) and renal AEs. MATERIALS AND METHODS Patient-level data from KEYNOTE-189 were analyzed in the all-subjects-as-treated population (pembrolizumab arm, n = 405; placebo arm, n = 202), and among patients who received ≥5 cycles of pemetrexed (pemetrexed/pembrolizumab/platinum arm, n = 310; pemetrexed/placebo/platinum arm, n = 135). All-cause AEs were selected based on ≥2 % incidence from previously reported KEYNOTE-189 data and included neutropenia, febrile neutropenia, anemia, thrombocytopenia, asthenia, fatigue, dyspnea, diarrhea, nausea, vomiting, pneumonitis, and renal events. Descriptive statistics summarized all-cause AEs. Medians and interquartile ranges were used to examine time-to-onset and time-to-resolution. The data cutoff was November 8, 2017. RESULTS In both treatment arms, most non-hematologic (nausea, vomiting, diarrhea, and asthenia), and hematologic (febrile neutropenia, thrombocytopenia, and neutropenia) grade ≥3 AEs with ≥2 % incidence had a median time-to-onset within the first 4 cycles, and a median time-to-resolution of within 2 weeks from onset. A small number of AEs had longer median time-to-onset (pneumonitis and fatigue) and median time-to-resolution (pneumonitis, fatigue, acute kidney injury, and anemia). Among patients who received ≥5 cycles of pemetrexed, the incidence of any-grade renal toxicity in the pemetrexed/pembrolizumab/platinum arm was 2.3 % in Cycles 1-4, 4.8 % in Cycles 5-8, 2.6 % in Cycles 9-12, and 2.5 % in Cycles ≥13; and, in the pemetrexed/placebo/platinum arm, 0.7 % in Cycles 1-4, 1.5 % in Cycles 5-8, 1.3 % in Cycles 9-12, and 2.0 % in Cycles ≥13. CONCLUSION Pemetrexed/pembrolizumab/platinum has manageable toxicity with longer duration of treatment. While the incidence of renal toxicity was slightly higher in the pembrolizumab combination as compared to pemetrexed, the incidence did not increase in later treatment cycles. These results support the safe use of the KEYNOTE-189 regimen in clinical practice. CLINICAL TRIAL REGISTRATION NUMBER NCT02578680 (clinicaltrials.gov).",2021,"A small number of AEs had longer median time-to-onset (pneumonitis and fatigue) and median time-to-resolution (pneumonitis, fatigue, acute kidney injury, and anemia).","['Patient-level data from KEYNOTE-189 were analyzed in the all-subjects-as-treated population (pembrolizumab arm, n\u202f=\u202f405; placebo arm, n\u202f=\u202f202), and among patients who received ≥5 cycles of', 'metastatic nonsquamous non-small cell lung cancer']","['pemetrexed/placebo/platinum', 'Pemetrexed/pembrolizumab/platinum', 'pemetrexed (pemetrexed/pembrolizumab/platinum arm, n\u202f=\u202f310; pemetrexed/placebo/platinum', 'pemetrexed/pembrolizumab/platinum', 'pemetrexed plus platinum', 'pembrolizumab', 'pemetrexed and platinum']","['hematologic (nausea, vomiting, diarrhea, and asthenia), and hematologic (febrile neutropenia, thrombocytopenia, and neutropenia) grade ≥3 AEs', 'renal toxicity', 'median time-to-onset (pneumonitis and fatigue) and median time-to-resolution (pneumonitis, fatigue, acute kidney injury, and anemia', 'time-to-onset and time-to-resolution of all-cause any-grade and grade ≥3 adverse events (AEs) and renal AEs', 'manageable toxicity', 'median time-to-onset', 'neutropenia, febrile neutropenia, anemia, thrombocytopenia, asthenia, fatigue, dyspnea, diarrhea, nausea, vomiting, pneumonitis, and renal events', 'incidence of any-grade renal toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4517768', 'cui_str': '405'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C5191352', 'cui_str': '310'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0595916', 'cui_str': 'Toxic nephropathy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C3714636', 'cui_str': 'Pneumonitis'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.162078,"A small number of AEs had longer median time-to-onset (pneumonitis and fatigue) and median time-to-resolution (pneumonitis, fatigue, acute kidney injury, and anemia).","[{'ForeName': 'Edward B', 'Initials': 'EB', 'LastName': 'Garon', 'Affiliation': 'David Geffen School of Medicine, University of California Los Angeles, 2825 Santa Monica Blvd, Santa Monica, CA, 90404, USA. Electronic address: egaron@mednet.ucla.edu.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Aerts', 'Affiliation': 'Erasmus University Medical Center, PO Box 2040, 3000 CA, Rotterdam, the Netherlands. Electronic address: j.aerts@erasmusmc.nl.'}, {'ForeName': 'Jong Seok', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA. Electronic address: kim_jong_seok@lilly.com.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Muehlenbein', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA. Electronic address: muehlenbein_catherine_e@lilly.com.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Peterson', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA. Electronic address: peterson_patrick@lilly.com.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Rizzo', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA. Electronic address: rizzo_maria_teresa@lilly.com.'}, {'ForeName': 'Shirish M', 'Initials': 'SM', 'LastName': 'Gadgeel', 'Affiliation': 'Henry Ford Cancer Institute/Henry Ford Health System, 2799 W Grand Blvd K13, Detroit, MI, 48202, USA. Electronic address: sgadgee1@hfhs.org.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2021.02.021'] 2511,33721365,"Randomized, double-blind, active-controlled, multicentre, phase III clinical trial with two stages to assess the safety and efficacy of letibotulinum toxin a vs. onabotulinum toxin a for subjects with moderate to severe crow's feet.","BACKGROUND Letibotulinum toxin A (LeBA) was approved by the Ministry of Food and Drug Safety (known as the Korea Food & Drug Administration) for cosmetic indications in 2012. However, the efficacy and safety of this newly introduced LeBA have not been investigated in crow's feet lines (CFL) treatment and standardization before its universal use. OBJECTIVE The aim of this multicentre, double-blind, randomized, parallel, active-controlled Phase III clinical trial with two stages (ClinicalTrials.gov identifier: NCT03408236) was to investigate the non-inferiority of LeBA vs. the existing onabotulinum toxin A (OnBA) for the treatment of CFL. METHODS A total of 240 subjects were randomized to either the test (LeBA) or control (OnBA) group. At the baseline and at weeks 4 while maximum smiling (primary efficacy assessment), 8, 12 and 16, investigator's on-site evaluation, independent evaluator, evaluation by the subjects, subjects' satisfaction assessment and safety assessment were performed. RESULTS At week 4, the response rate of primary efficacy assessment was 69.75% and 68.33% in the test (LeBA) and control (OnBA) groups, respectively, without a significant difference. Other minor secondary evaluation results showed significant differences suggesting that LeBA offered better improvement than OnBA, but the overall results did not show significant differences between the two groups. CONCLUSION This study showed that LeBA was as effective and safe as OnBA for the treatment of CFL at the same doses.",2021,"Other minor secondary evaluation results showed significant differences suggesting that LeBA offered better improvement than OnBA, but the overall results did not show significant differences between the two groups. ","[""Subjects with Moderate to Severe Crow's Feet"", '240 subjects']","['test (LeBA) or control (OnBA', 'Letibotulinum toxin A versus Onabotulinum toxin A', 'LeBA', 'LeBA versus the existing onabotulinum toxin A (OnBA']","['response rate of primary efficacy assessment', 'efficacy and safety', ""investigator's on-site evaluation, independent evaluator, evaluation by the subjects, subjects' satisfaction assessment, and safety assessment"", 'Safety and Efficacy']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0277939', 'cui_str': ""Crow's feet""}, {'cui': 'C4319600', 'cui_str': '240'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0076851', 'cui_str': 'toxin A (Pseudomonas)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4743433', 'cui_str': 'onabotulinum toxin A'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",240.0,0.42803,"Other minor secondary evaluation results showed significant differences suggesting that LeBA offered better improvement than OnBA, but the overall results did not show significant differences between the two groups. ","[{'ForeName': 'K H', 'Initials': 'KH', 'LastName': 'Yoo', 'Affiliation': 'Department of Dermatology, College of Medicine, Chung-Ang University Hospital, Seoul, Korea.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Dermatology, College of Medicine, Chung-Ang University Hospital, Seoul, Korea.'}, {'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Han', 'Affiliation': 'Department of Dermatology, College of Medicine, Chung-Ang University Hospital, Seoul, Korea.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Won', 'Affiliation': 'Department of Dermatology, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea.'}, {'ForeName': 'Y W', 'Initials': 'YW', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, College of Medicine, Konkuk University Hospital, Seoul, Korea.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, College of Medicine, Chung-Ang University Hospital, Seoul, Korea.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.17217'] 2512,33725995,Effects of probiotics on gastrointestinal complications and nutritional status of postoperative patients with esophageal cancer: A protocol of randomized controlled trial.,"BACKGROUND Gastrointestinal complications and malnutrition are common problems that affect postoperative rehabilitation and survival of patients with esophageal cancer. Evidence has shown that probiotics have a positive effect on improving gastrointestinal complications and nutritional status of patients with esophageal cancer after surgery, but there is a lack of prospective studies on this topic. We designed this prospective randomized controlled trial to evaluate the effects of probiotics on gastrointestinal complications and nutritional status in patients with postoperative esophageal cancer. METHODS This is a prospective, randomized, double-blind, placebo-controlled trial. It was approved by the Clinical Research Ethics Committee of our hospital. 192 patients will be randomly divided into probiotics group and the placebo group in a 1:1 ratio. After operation, probiotics and placebo will be given orally for 8 weeks. The indexes of nutritional status and incidence of digestive tract complications will be recorded and the data will be analyzed by SPSS 18.0 software. DISCUSSION This study will evaluate the effect of probiotics on gastrointestinal complications and nutritional status of postoperative patients with esophageal cancer. The results of this study will provide clinical basis for the use of probiotics in postoperative treatment of esophageal cancer. TRIAL REGISTRATION OSF Registration number: D DOI 10.17605/OSF.IO/QHW86.",2021,"The indexes of nutritional status and incidence of digestive tract complications will be recorded and the data will be analyzed by SPSS 18.0 software. ","['patients with postoperative esophageal cancer', 'postoperative patients with esophageal cancer', '192 patients', 'patients with esophageal cancer', 'patients with esophageal cancer after surgery']","['probiotics', 'placebo', 'probiotics and placebo']","['gastrointestinal complications and nutritional status', 'indexes of nutritional status and incidence of digestive tract complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C4517623', 'cui_str': '192'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0161819', 'cui_str': 'Gastrointestinal complication'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",192.0,0.363425,"The indexes of nutritional status and incidence of digestive tract complications will be recorded and the data will be analyzed by SPSS 18.0 software. ","[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'The NO.2 Hospital of Baoding Department of Gastroenterology.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'The NO.2 Hospital of Baoding Department of Gastroenterology.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Dong', 'Affiliation': 'The NO.2 Hospital of Baoding Department of Gastroenterology.'}, {'ForeName': 'Jinyan', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': ""Shanxi Provincial People's Hospital Thoracic Surgery.""}]",Medicine,['10.1097/MD.0000000000025138'] 2513,33725978,Critical thinking intervention for stress reduction among undergraduates in the Nigerian Universities.,"BACKGROUND The stress level of undergraduates is increasing at an alarming rate. This study's objective was to determine the effect of critical thinking intervention (CTI) for stress reduction among undergraduates in Nigerian Universities. METHODS This research used a pretest-posttest design. Participants were 103 undergraduates who had experienced a high level of stress. The Academic Stress Questionnaire (ASQ) and the Educational Stress Scale (ESSS) were the measures used for data collection in the study, while repeated measures analysis of variance was used for data analysis. RESULTS Before the intervention, assessment results showed that the stress level of participants was high, with no difference between those undergraduates in the treatment group and those in the no-treatment control group. After the intervention, the assessment results indicated a significant reduction in the undergraduates' stress level in the treatment group compared to those in the no-treatment control group. Further significant reduction was observed in the undergraduates' stress level in the treatment group compared to those in the no-treatment control group after follow-up assessment. CONCLUSION The authors concluded that CTI intervention was significantly effective for stress reduction among undergraduates in Nigerian Universities. Therefore, counselors are called upon to adopt the principle of CTI intervention to help patients under stress reduce their stress levels.",2021,"Further significant reduction was observed in the undergraduates' stress level in the treatment group compared to those in the no-treatment control group after follow-up assessment. ","['Participants were 103 undergraduates who had experienced a high level of stress', 'undergraduates in Nigerian Universities', 'undergraduates in the Nigerian Universities']","['critical thinking intervention (CTI', 'CTI intervention', 'Critical thinking intervention']","['stress reduction', ""undergraduates' stress level"", 'Academic Stress Questionnaire (ASQ) and the Educational Stress Scale (ESSS']","[{'cui': 'C2745478', 'cui_str': 'AM103'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C1556089', 'cui_str': 'Nigerians'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C4279941', 'cui_str': 'Critical Thinking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",103.0,0.0508136,"Further significant reduction was observed in the undergraduates' stress level in the treatment group compared to those in the no-treatment control group after follow-up assessment. ","[{'ForeName': 'Felix Okechukwu', 'Initials': 'FO', 'LastName': 'Ugwuozor', 'Affiliation': 'Department of Educational Foundations, Faculty of Education, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Mkpoikanke Sunday', 'Initials': 'MS', 'LastName': 'Otu', 'Affiliation': ''}, {'ForeName': 'Isaac Nnamdi', 'Initials': 'IN', 'LastName': 'Mbaji', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000025030'] 2514,33727090,Preliminary evidence for a race-based stress reduction intervention for Black women at risk for cardiovascular disease.,"OBJECTIVE Despite evidence that chronic stress, racism, and discrimination impact the well-being and the risk for cardiovascular disease (CVD) in Black women, there are few evidence-based interventions that improve well-being and reduce the risk for CVD in women of minority groups. The purpose of this pilot study was to evaluate the psychobehavioral and anti-inflammatory benefit of a race-based stress reduction program ""Resilience, Stress, and Ethnicity (RiSE) for Black women at risk for CVD. METHODS Black women were recruited from the Chicagoland community and randomized to either the 8-week RiSE intervention (n = 40) or control group (n = 34). Participants were assessed for coping strategies, psychological distress, and blood levels of TNF-alpha and high sensitivity C-reactive protein (hsCRP) at baseline and at 4 and 8 weeks after baseline. RESULTS Participation in RiSE was associated with a more rapid decline in the use of avoidance coping (b = -0.3585, SE = 0.1705, p < .01). Reductions over time in TNF-alpha (b = -0.0163, SE = .0087, p = .08) and hsCRP (b= -0.4064, SE = 0.2270, p = .08) approached statistical significance. CONCLUSIONS Findings provide preliminary evidence in Black women at risk for CVD that RiSE contributes to decreases in avoidance coping. Although preliminary, these results suggest RiSE to be an effective intervention to promote improved coping associated with racism and discrimination in minorities.",2021,"Reductions over time in TNF-alpha (b = -0.0163, SE = .0087, p = .08) and hsCRP (","['Black women at risk for CVD', 'Black Women at Risk for Cardiovascular Disease', 'Black women', 'Black women were recruited from the Chicagoland community and randomized to either the 8-week']","['race-based stress reduction program ""Resilience, Stress, and Ethnicity (RiSE', 'RiSE intervention (n\u2009=\u200940) or control group', 'Race-Based Stress Reduction Intervention']","['coping strategies, psychological distress, and blood levels of TNF-alpha and high sensitivity C-reactive protein (hsCRP', 'avoidance coping', 'Reductions over time in TNF-alpha']","[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1448177', 'cui_str': 'TNF protein, human'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.063114,"Reductions over time in TNF-alpha (b = -0.0163, SE = .0087, p = .08) and hsCRP (","[{'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Saban', 'Affiliation': 'Loyola University Chicago, Marcella Niehoff School of Nursing, 2160 S First Ave, Center for Translational Research and Education, Maywood, IL, 60153, United States. Electronic address: ksaban@luc.edu.'}, {'ForeName': 'Darnell', 'Initials': 'D', 'LastName': 'Motley', 'Affiliation': 'University of Chicago, The Center for Interdisciplinary Inquiry and Innovation in Sexual and Reproductive Health, 6030 South Ellis Avenue, Chicago, IL, 60637, United States. Electronic address: dmotley@bsd.uchicago.edu.'}, {'ForeName': 'Lamise', 'Initials': 'L', 'LastName': 'Shawahin', 'Affiliation': 'Governors State University, Division of Psychology and Counseling, 1 University Parkway, University Park, IL, 60484, United States. Electronic address: lshawahin@govst.edu.'}, {'ForeName': 'Herbert L', 'Initials': 'HL', 'LastName': 'Mathews', 'Affiliation': 'Loyola University Chicago, Department of Microbiology and Immunology, 2160 S. First Ave., Center for Translational Research and Education, Maywood, IL, 60153, United States. Electronic address: hmathew@luc.edu.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Tell', 'Affiliation': 'Loyola University Chicago, Marcella Niehoff School of Nursing, 2160 S First Ave, Center for Translational Research and Education, Maywood, IL, 60153, United States. Electronic address: dtell@luc.edu.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'De La Pena', 'Affiliation': 'Loyola University Chicago, Marcella Niehoff School of Nursing, 2160 S First Ave, Center for Translational Research and Education, Maywood, IL, 60153, United States. Electronic address: pdelapena@luc.edu.'}, {'ForeName': 'Linda Witek', 'Initials': 'LW', 'LastName': 'Janusek', 'Affiliation': 'Loyola University Chicago, Marcella Niehoff School of Nursing, 2160 S First Ave, Center for Translational Research and Education, Maywood, IL, 60153, United States. Electronic address: ljanuse@luc.edu.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2021.102710'] 2515,33730151,"Perioperative Methadone and Ketamine for Postoperative Pain Control in Spinal Surgical Patients: A Randomized, Double-blind, Placebo-controlled Trial.","BACKGROUND Despite application of multimodal pain management strategies, patients undergoing spinal fusion surgery frequently report severe postoperative pain. Methadone and ketamine, which are N-methyl-d-aspartate receptor antagonists, have been documented to facilitate postoperative pain control. This study therefore tested the primary hypothesis that patients recovering from spinal fusion surgery who are given ketamine and methadone use less hydromorphone on the first postoperative day than those give methadone alone. METHODS In this randomized, double-blind, placebo-controlled trial, 130 spinal surgery patients were randomized to receive either methadone at 0.2 mg/kg (ideal body weight) intraoperatively and a 5% dextrose in water infusion for 48 h postoperatively (methadone group) or 0.2 mg/kg methadone intraoperatively and a ketamine infusion (0.3 mg · kg-1 · h-1 infusion [no bolus] intraoperatively and then 0.1 mg · kg-1 · h-1 for next 48 h [both medications dosed at ideal body weight]; methadone/ketamine group). Anesthetic care was standardized in all patients. Intravenous hydromorphone use on postoperative day 1 was the primary outcome. Pain scores, intravenous and oral opioid requirements, and patient satisfaction with pain management were assessed for the first 3 postoperative days. RESULTS Median (interquartile range) intravenous hydromorphone requirements were lower in the methadone/ketamine group on postoperative day 1 (2.0 [1.0 to 3.0] vs. 4.6 [3.2 to 6.6] mg in the methadone group, median difference [95% CI] 2.5 [1.8 to 3.3] mg; P < 0.0001) and postoperative day 2. In addition, fewer oral opioid tablets were needed in the methadone/ketamine group on postoperative day 1 (2 [0 to 3] vs. 4 [0 to 8] in the methadone group; P = 0.001) and postoperative day 3. Pain scores at rest, with coughing, and with movement were lower in the methadone/ketamine group at 23 of the 24 assessment times. Patient-reported satisfaction scores were high in both study groups. CONCLUSIONS Postoperative analgesia was enhanced by the combination of methadone and ketamine, which act on both N-methyl-d-aspartate and μ-opioid receptors. The combination could be considered in patients having spine surgery. EDITOR’S PERSPECTIVE ",2021,"Pain scores at rest, with coughing, and with movement were lower in the methadone/ketamine group at 23 of the 24 assessment times.","['patients having spine surgery', 'Spinal Surgical Patients', '130 spinal surgery patients', 'patients recovering from spinal fusion surgery who are given', 'on the first postoperative day than those give methadone alone', 'patients undergoing spinal fusion surgery frequently report severe postoperative pain']","['Methadone and ketamine', 'methadone/ketamine', 'methadone', 'Intravenous hydromorphone', 'ketamine and methadone', 'placebo', 'hydromorphone', 'methadone and ketamine', 'Methadone and Ketamine', 'methadone at 0.2 mg/kg (ideal body weight) intraoperatively and a 5% dextrose in water infusion for 48 h postoperatively (methadone group) or 0.2 mg/kg methadone intraoperatively and a ketamine infusion (0.3 mg · kg-1 · h-1 infusion [no bolus] intraoperatively and then 0.1 mg · kg-1 · h-1 for next 48 h [both medications dosed at ideal body weight]; methadone/ketamine']","['Median (interquartile range) intravenous hydromorphone requirements', 'Pain scores', 'Anesthetic care', 'Pain scores, intravenous and oral opioid requirements, and patient satisfaction with pain management', 'satisfaction scores']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0920347', 'cui_str': 'Procedure on spinal cord'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0919636', 'cui_str': 'Spinal fusion surgery'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0421272', 'cui_str': 'Ideal body weight'}, {'cui': 'C0985452', 'cui_str': 'Glucose 50 MG/ML'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",130.0,0.417364,"Pain scores at rest, with coughing, and with movement were lower in the methadone/ketamine group at 23 of the 24 assessment times.","[{'ForeName': 'Glenn S', 'Initials': 'GS', 'LastName': 'Murphy', 'Affiliation': ''}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Avram', 'Affiliation': ''}, {'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Greenberg', 'Affiliation': ''}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Benson', 'Affiliation': ''}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Bilimoria', 'Affiliation': ''}, {'ForeName': 'Colleen E', 'Initials': 'CE', 'LastName': 'Maher', 'Affiliation': ''}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Teister', 'Affiliation': ''}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Szokol', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003743'] 2516,33714169,Scalp acupuncture therapy combined with exercise can improve the ability of stroke patients to participate in daily activities.,"OBJECTIVE To observe the improvement of stroke patients' ability to participate in daily activities by using Scalp acupuncture therapy combined with exercise. METHODS According to random number table, patients were divided into a treatment group, which received rehabilitation training and scalp acupuncture to retain needles at different times, and a control group, which received rehabilitation training alone. The Barthel index was used to evaluate the activities of daily living before and after treatment. RESULTS The scores of Barthel index of all groups were higher than those before treatment, and the scalp acupuncture for 2 h combined with rehabilitation training group had the highest score. There was significant difference compared with pre-treatment and other treatment groups. CONCLUSION Scalp acupuncture therapy combined with exercise therapy can significantly improve the ability of stroke patients to participate in daily activities; 2 h of scalp acupuncture combined with exercise therapy had the most significant effect.",2021,"The scores of Barthel index of all groups were higher than those before treatment, and the scalp acupuncture for 2 h combined with rehabilitation training group had the highest score.",[],"['rehabilitation training and scalp acupuncture to retain needles at different times, and a control group, which received rehabilitation training alone', 'rehabilitation training', 'Scalp acupuncture therapy combined with exercise', 'Scalp acupuncture therapy combined with exercise therapy']",['scores of Barthel index'],[],"[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}]",,0.0184712,"The scores of Barthel index of all groups were higher than those before treatment, and the scalp acupuncture for 2 h combined with rehabilitation training group had the highest score.","[{'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, No. 33 Beiling Street, 110032, China. Electronic address: hero9024@163.com.'}, {'ForeName': 'Bojin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Liaoning University of Traditional Chinese Medicine, No. 79 Chongshan East Road, 110847, China.'}, {'ForeName': 'Xuefeng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, No. 33 Beiling Street, 110032, China.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101343'] 2517,33706066,Benefits of Thai Yoga on physical mobility and lower limb muscle strength in overweight/obese older women: A randomized controlled pilot trial.,"BACKGROUND AND PURPOSE Although Thai Yoga (TY) is reported to improve health-related fitness for the elderly, no study has yet carried out the effect of TY Program on physical mobility and lower-limb muscle strength in overweight/obese older women. MATERIALS AND METHODS In a randomized controlled pilot design, twenty-two sedentary women with a BMI ≥ 23 kg/m 2 , aged 62 ± 1 years were randomly assigned to either a TY group for 60 min, 3 times a week or to a ""no exercise"" control (CON) group. Sit and reach (SRT), functional reach (FRT) and 30-s chair stand (CST-30), 8-foot up and go (8UGT), 6-min walk (6MWT)) and lower-limb muscle strength were measured at the beginning, 4, and 8 weeks. RESULTS At week 4, a significant between groups was obtained in CST-30, 8UGT, and 6MWT. At week 8, FRT, 8UGT, 6MWT and knee flexor and extensor muscle strength were improved in the TY over the CON. Significant improvement was found in all variables within the TY, but no change was observed in the CON. CONCLUSION An 8-week TY program appears to provide beneficial improvements in physical mobility in overweight/obese older women.",2021,"At week 4, a significant between groups was obtained in CST-30, 8UGT, and 6MWT.","['twenty-two sedentary women with a BMI\xa0≥\xa023\xa0kg', 'overweight/obese older women', 'm 2 , aged 62\xa0±\xa01 years']","['no exercise"" control (CON', 'Thai Yoga']","['CST-30, 8UGT, and 6MWT', 'physical mobility', 'FRT, 8UGT, 6MWT and knee flexor and extensor muscle strength', 'Sit and reach (SRT), functional reach (FRT) and 30-s chair stand (CST-30), 8-foot up and go (8UGT), 6-min walk (6MWT)) and lower-limb muscle strength', 'physical mobility and lower limb muscle strength']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}]","[{'cui': 'C0560172', 'cui_str': 'cSt'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0341703', 'cui_str': 'Adult Fanconi syndrome'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C1321055', 'cui_str': 'Functional reach'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",22.0,0.0324693,"At week 4, a significant between groups was obtained in CST-30, 8UGT, and 6MWT.","[{'ForeName': 'Waree', 'Initials': 'W', 'LastName': 'Widjaja', 'Affiliation': 'College of Sports Science and Technology, Mahidol University, Thailand.'}, {'ForeName': 'Thanarak', 'Initials': 'T', 'LastName': 'Wongwattanapong', 'Affiliation': 'College of Sports Science and Technology, Mahidol University, Thailand.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Laskin', 'Affiliation': 'School of Physical Therapy & Rehabilitation Sciences, University of Montana, USA.'}, {'ForeName': 'Amornpan', 'Initials': 'A', 'LastName': 'Ajjimaporn', 'Affiliation': 'College of Sports Science and Technology, Mahidol University, Thailand. Electronic address: amornpan.ajj@mahidol.ac.th.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101345'] 2518,33738560,Computed tomography versus fluoroscopic guided-sacroiliac joint injection: a prospective comparative study.,"BACKGROUND There are limited data discussing long-term pain relief and comparability of different image-guided sacroiliac joint (SIJ) injection. This study compared CT and fluoroscopic-guided SIJ injections regarding statistically and clinically significant differences in numeric pain reduction, radiation doses, and patient's satisfaction. METHODS A prospective study conducted on 52 patients who met specific inclusion criteria of SIJ pain. A mixture of 1 ml of 40 mg methylprednisolone acetate diluted in 2 ml of lidocaine 2% was injected under either CT or fluoroscopic guidance. Numeric rating score (NRS) and Oswestry disability index (ODI) were assessed and recorded for each patient before procedure and one-week, and one-, three-, six-, and 12-months after procedure. The results were compared between both groups. RESULTS Analysis of NRS one-month post-procedure showed a significant decrease from baseline in both groups: 12.5% in CT group (p = 0.002) and 9.5% in fluoroscopic group (p = 0.006). No significant difference in NRS between two groups at one- and three-months post-procedure (p = 0.11 and 0.1, respectively). There was a significant difference in NRS between two groups at six- and 12-months post-procedure (p = 0.001 and < 0.0001, respectively). Comparison of ODI at six-month post-procedure revealed that both groups had a statistically significant improvement (p < 0.0001). There was a significant difference in ODI between two groups at six-months post-procedure (p = 0.01). CONCLUSIONS CT-guided SIJ injection compares favorably with fluoroscopic guidance and offers statistically and clinically significant long-term pain relief. The use of dose reduction protocol in CT is important for decreasing the radiation dose.",2021,"No significant difference in NRS between two groups at one- and three-months post-procedure (p = 0.11 and 0.1, respectively).",['52 patients who met specific inclusion criteria of SIJ pain'],"['Computed tomography versus fluoroscopic guided-sacroiliac joint injection', 'CT-guided SIJ injection', 'CT and fluoroscopic-guided SIJ injections', 'methylprednisolone acetate', 'lidocaine']","['Numeric rating score (NRS) and Oswestry disability index (ODI', ""numeric pain reduction, radiation doses, and patient's satisfaction"", 'ODI', 'NRS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0458232', 'cui_str': 'Sacroiliac joint pain'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0394852', 'cui_str': 'Injection of sacroiliac joint'}, {'cui': 'C0600901', 'cui_str': 'Methylprednisolone acetate'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",52.0,0.026497,"No significant difference in NRS between two groups at one- and three-months post-procedure (p = 0.11 and 0.1, respectively).","[{'ForeName': 'Ahmed A A', 'Initials': 'AAA', 'LastName': 'Bessar', 'Affiliation': 'Department of Radiodiagnosis, Faculty of Human Medicine, Zagazig University, Zagazig, Egypt. Ahmedawadbessar@gmail.com.'}, {'ForeName': 'Mohamed M', 'Initials': 'MM', 'LastName': 'Arnaout', 'Affiliation': 'Department of Neurosurgery, Faculty of Human Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Mohammad Abd Alkhalik', 'Initials': 'MAA', 'LastName': 'Basha', 'Affiliation': 'Department of Radiodiagnosis, Faculty of Human Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Shady E', 'Initials': 'SE', 'LastName': 'Shaker', 'Affiliation': 'Department of Internal Medicine, Faculty of Human Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Ashraf E', 'Initials': 'AE', 'LastName': 'Elsayed', 'Affiliation': 'Department of Anesthesia, Surgical Intensive Care and Pain Medicine, Faculty of Human Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Manar Awad', 'Initials': 'MA', 'LastName': 'Bessar', 'Affiliation': 'Department of Radiodiagnosis, Faculty of Human Medicine, Zagazig University, Zagazig, Egypt.'}]",Insights into imaging,['10.1186/s13244-021-00982-y'] 2519,33735709,High-dose baclofen attenuates insula activation during anticipatory anxiety in treatment-seeking alcohol dependant individuals: Preliminary findings from a pharmaco-fMRI study.,"The GABA B agonist, baclofen, has been shown to reduce alcohol consumption in patients with alcohol use disorder and also those with comorbid anxiety. This study aimed to evaluate the effect of baclofen versus placebo on the BOLD response during an anticipatory anxiety fMRI task in treatment seeking alcohol patients. Participants included 28 alcohol dependant individuals who had received daily baclofen 30 mg (n = 10), 75 mg (n = 8) or placebo (n = 10) for at least 2 week on a randomized controlled trial (Morley, Leung et al. 2013, Morley, Baillie et al. 2018). Using functional magnetic resonance imaging (fMRI), we examined threat cue-elicited neural activation during a threat reactivity task 120 min following administration of BAC (30 mg or 75 mg) or placebo. Whole-brain analyses revealed no significant differences between the combined BAC doses versus PL. However, there were significant decreases in anticipatory threat cue-elicited activation observed in BAC 75 mg/day compared to PL participants in the insula. In response to threat cues, high dose (75 mg/day) baclofen administration attenuates activation in the insula and inferior frontal gyrus, relative to placebo. These preliminary findings suggests that modulating emotional regulation and attentional allocation during high threat stimuli may be mediated by GABA B receptors and may be a potential mechanism of action for baclofen's beneficial treatment effects for alcohol use disorder.",2021,"In response to threat cues, high dose (75 mg/day) baclofen administration attenuates activation in the insula and inferior frontal gyrus, relative to placebo.","['treatment-seeking alcohol dependant individuals', 'patients with alcohol use disorder and also those with comorbid anxiety', 'treatment seeking alcohol patients', 'Participants included 28 alcohol dependant individuals who had received daily baclofen 30\xa0mg (n\xa0=\xa010), 75\xa0mg (n\xa0=\xa08) or']","['High-dose baclofen', 'functional magnetic resonance imaging (fMRI', 'placebo', 'BAC ', 'baclofen versus placebo']","['BOLD response', 'anticipatory threat cue-elicited activation']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004609', 'cui_str': 'Baclofen'}]","[{'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0004609', 'cui_str': 'Baclofen'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004599', 'cui_str': 'Bacitracin'}]","[{'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}]",,0.0867909,"In response to threat cues, high dose (75 mg/day) baclofen administration attenuates activation in the insula and inferior frontal gyrus, relative to placebo.","[{'ForeName': 'Kirsten C', 'Initials': 'KC', 'LastName': 'Morley', 'Affiliation': 'Discipline of Addiction Medicine, Central Clinical School, Faculty of Medicine and Health, University of Sydney, NSW, Australia; Edith Collins Centre (Translational Research in Alcohol, Drugs and Toxicology), Sydney Local Health District, Sydney, NSW, Australia. Electronic address: kirsten.morley@sydney.edu.au.'}, {'ForeName': 'Warren B', 'Initials': 'WB', 'LastName': 'Logge', 'Affiliation': 'Discipline of Addiction Medicine, Central Clinical School, Faculty of Medicine and Health, University of Sydney, NSW, Australia; Drug Health Services, Royal Prince Alfred Hospital, NSW, Australia; Edith Collins Centre (Translational Research in Alcohol, Drugs and Toxicology), Sydney Local Health District, Sydney, NSW, Australia.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Fraser', 'Affiliation': 'Discipline of Addiction Medicine, Central Clinical School, Faculty of Medicine and Health, University of Sydney, NSW, Australia.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Morris', 'Affiliation': 'Psychological Medicine, Central Clinical School, Faculty of Medicine and Health, University of Sydney, NSW, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Baillie', 'Affiliation': 'Faculty of Health Sciences, University of Sydney, NSW, Australia.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Haber', 'Affiliation': 'Discipline of Addiction Medicine, Central Clinical School, Faculty of Medicine and Health, University of Sydney, NSW, Australia; Drug Health Services, Royal Prince Alfred Hospital, NSW, Australia; Edith Collins Centre (Translational Research in Alcohol, Drugs and Toxicology), Sydney Local Health District, Sydney, NSW, Australia.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2021.02.010'] 2520,33735707,Do effects of methylphenidate on cognitive performance last beyond treatment? A randomized placebo-controlled trial in boys and men with ADHD.,"Methylphenidate (MPH) is the first-choice pharmacological treatment for treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) across the lifespan. However, it is unclear whether MPH affects cognitive development, while recent (pre-) clinical studies suggest effects on the developing brain. The present randomized, placebo-controlled trial aims to determine whether MPH has short-term, age-dependent effects on cognitive performance in ADHD after a 1-week washout. Effects of 16 weeks MPH treatment were assessed after a one-week washout on cognitive functioning. Boys (age=10-12) and men (age=23-40) with ADHD were assigned to MPH treatment (boys n=25, men n=24) or placebo (boys n=25, men n=24). Outcome measures were working memory, response inhibition, response speed, episodic memory, and delay aversion. Differences in task performances over time (pre-, mid-, and post-treatment, following a 1-week wash-out) were compared between age and treatment conditions with mixed ANOVAs. MPH improved working memory and response speed, but only during treatment. No lasting age*treatment effects were observed post intervention. Overall, the results from the present randomized, placebo-controlled trial show that the effects of MPH on cognition do not extend past treatment in children or adults. While treatment with MPH improves cognition during treatment, these effects appear transient after 16-weeks of treatment. (Title trial: ""Effects of methylphenidate on the developing brain""; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3103).",2021,"MPH improved working memory and response speed, but only during treatment.","['children or adults', 'boys and men with ADHD', 'boys n=25, men n=24', 'Boys (age=10-12) and men (age=23-40) with ADHD', 'boys n=25, men n=24) or']","['Methylphenidate (MPH', 'placebo', 'MPH', 'MPH treatment', 'methylphenidate']","['cognitive performance', 'cognitive functioning', 'MPH improved working memory and response speed', 'working memory, response inhibition, response speed, episodic memory, and delay aversion']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0233496', 'cui_str': 'Aversion'}]",40.0,0.249755,"MPH improved working memory and response speed, but only during treatment.","[{'ForeName': 'Hyke G H', 'Initials': 'HGH', 'LastName': 'Tamminga', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands; Dutch\xa0Autism and ADHD Research Center, University of Amsterdam, Nieuwe achtergracht 129, 1018 Amsterdam, The Netherlands.'}, {'ForeName': 'Liesbeth', 'Initials': 'L', 'LastName': 'Reneman', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands; Amsterdam Brain and Cognition, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Anouk', 'Initials': 'A', 'LastName': 'Schrantee', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands; Amsterdam Brain and Cognition, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Bottelier', 'Affiliation': 'Center for child- and adolescent psychiatry Triversum, Alkmaar, The Netherlands.'}, {'ForeName': 'Cheima', 'Initials': 'C', 'LastName': 'Bouziane', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Hilde M', 'Initials': 'HM', 'LastName': 'Geurts', 'Affiliation': 'Dutch\xa0Autism and ADHD Research Center, University of Amsterdam, Nieuwe achtergracht 129, 1018 Amsterdam, The Netherlands; Amsterdam Brain and Cognition, University of Amsterdam, Amsterdam, The Netherlands; Research Priority Area Yield, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Annabeth P', 'Initials': 'AP', 'LastName': 'Groenman', 'Affiliation': 'Dutch\xa0Autism and ADHD Research Center, University of Amsterdam, Nieuwe achtergracht 129, 1018 Amsterdam, The Netherlands. Electronic address: a.p.groenman@uva.nl.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2021.02.002'] 2521,33721689,Intermittent vibrational stimulation enhances mobility during stair navigation in patients with knee pain.,"BACKGROUND Reduced quadriceps function and proprioception can cause decreased mobility during stair navigation in patients with knee pain. Patients can benefit from interventions to mitigate pain and restore quadriceps function. Activating the somatosensory system via intermittent vibrational stimulation has the potential to improve stair navigation mobility in patients with knee pain by moderating quadriceps inhibition and enhancing proprioception. RESEARCH QUESTION What are the effects of intermittent vibrational stimulus synchronized to stair ambulation on muscle activity, kinematics, kinetics, and pain using a randomized controlled clinical trial design. METHODS Thirty-eight patients with knee pain were enrolled into a blinded cross-over study, and twenty-nine patients completed all assessments and analyses. Subjects were randomly assigned sequentially to both an active Treatment A (active) and passive Treatment B (passive) worn at the knee during ambulation for 4 weeks with a 2-week washout period between treatments. RESULTS Knee pain during stair navigation was significantly reduced only with Treatment A (P = 0.007). During ascent, Treatment A (active) significantly increased vastus lateralis activation (P = 0.01), increased knee flexion moment (P = 0.04) and decreased trunk flexion angles (P = 0.015) between baseline and 4-week follow-up. After using passive Treatment B, there were no significant differences in pain (P = 0.19), knee flexion moment (P = 0.09), and trunk flexion angles (P = 0.23). Changes in muscle function correlated significantly with changes in knee flexion moment and trunk flexion with Treatment A (P < 0.015). Descending differed from ascending in response to Treatment A with significantly decreased knee flexion moment(P = 0.04), hip(P = 0.02) and ankle(P = 0.04) flexion angles. Treatment B significantly reduced hip flexion angles (P = 0.005) but not knee flexion moment (P = 0.85). SIGNIFICANCE The results of this study suggest that intermittent vibration can improve joint motion and loading during stair navigation by enhancing quadriceps function during stair ascent and improving movement control during stair descent by modifying an adaptive flexed movement pattern in the lower limb.",2021,"During ascent, Treatment A (active) significantly increased vastus lateralis activation (P = 0.01), increased knee flexion moment (P = 0.04) and decreased trunk flexion angles (P = 0.015) between baseline and 4-week follow-up.","['patients with knee pain', 'Thirty-eight patients with knee pain']","['active Treatment A (active) and passive Treatment B (passive) worn at the knee during ambulation', 'Intermittent vibrational stimulation']","['knee flexion moment', 'knee flexion moment(P', 'Knee pain during stair navigation', 'pain', 'muscle function', 'trunk flexion angles', 'hip flexion angles', 'muscle activity, kinematics, kinetics, and pain', 'vastus lateralis activation', 'knee flexion moment and trunk flexion', 'stair navigation mobility']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0450361', 'cui_str': '38'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C4302601', 'cui_str': 'During ambulation'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C1290942', 'cui_str': 'Climbing stairs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]",38.0,0.0310784,"During ascent, Treatment A (active) significantly increased vastus lateralis activation (P = 0.01), increased knee flexion moment (P = 0.04) and decreased trunk flexion angles (P = 0.015) between baseline and 4-week follow-up.","[{'ForeName': 'Arielle G', 'Initials': 'AG', 'LastName': 'Fischer', 'Affiliation': 'Department of Biomedical Engineering, Technion - Israel Institute of Technology, Haifa, Israel; Department of Mechanical Engineering, Stanford University, Stanford, CA, United States. Electronic address: ariellef@technion.ac.il.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Erhart-Hledik', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University, Stanford, CA, United States; Palo Alto Veterans Hospital, Palo Alto, CA, United States.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Asay', 'Affiliation': 'Department of Mechanical Engineering, Stanford University, Stanford, CA, United States; Palo Alto Veterans Hospital, Palo Alto, CA, United States.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Andriacchi', 'Affiliation': 'Department of Mechanical Engineering, Stanford University, Stanford, CA, United States.'}]",Gait & posture,['10.1016/j.gaitpost.2021.03.013'] 2522,33721623,Efficacy of myoinositol in treatment of gestational diabetes mellitus in Asian Indian women: A pilot randomized clinical trial.,"OBJECTIVE To compare efficacy of myoinositol as an adjuvant to dietary modification for treatment of gestational diabetes mellitus in Asian Indian women compared to controls. STUDY DESIGN Setting: This pilot randomized open label trial was conducted in a single antenatal clinic in India. SUBJECTS One hundred women with singleton pregnancy and gestational diabetes diagnosed between 14-28 weeks' gestation were included. Overt diabetes, twin pregnancy, pre-existing renal disease, heart disease and other chronic medical disorders were exclusions. INTERVENTION Participants were randomized in two groups (1:1 ratio) by opaque envelope method. Individualized nutrition counseling with dietary modification and routine antenatal care was provided to all. Fifty women received myoinositol 1000 mg twice daily; 50 controls did not receive myoinositol. Fasting and postprandial glucose levels were assessed after two weeks. Women not achieving glycemic targets (fasting glucose <95 and postprandial glucose <120 mg/dL) were given pharmacologic therapy. Contributory factors in women requiring additional pharmacologic therapy, maternal and fetal outcomes were noted. STATISTICAL ANALYSIS Between group comparisons reported relative risk and mean difference. To assess predictive factors for need for pharmacologic therapy, univariate and multivariable logistic regression analysis were used. RESULTS Baseline characteristics were comparable in both groups. Except one woman in the myoinositol group, all women provided glycaemia data throughout their pregnancy. Glycemic control was achieved in 44/ 49 (89.8 %) women in myoinositol group which was significantly higher than 34/50 (68 %) in the controls ((relative risk 0.31, 95 % confidence interval 0.13 to 0.80, p = 0.008). Mean duration of myoinositol treatment was 17.6 weeks (standard deviation 5.3). Additional treatment with metformin/insulin was needed in all women failing to achieve glycaemic control. The mean (range) dose of insulin was 25.3 units in myoinositol group compared to 14.27 units in controls (p = 0.058). Secondary outcomes were similar in two groups except baby weight which was higher in controls (p = 0.018). CONCLUSIONS Oral supplementation with myoinositol in dose of 1 gm twice-daily, when started soon after the diagnosis of GDM, is effective in achieving glycemic control and decreasing the need for additional pharmacological therapy in Asian Indian women.",2021,"Secondary outcomes were similar in two groups except baby weight which was higher in controls (p = 0.018). ","['gestational diabetes mellitus in Asian Indian women', 'Setting', ""One hundred women with singleton pregnancy and gestational diabetes diagnosed between 14-28 weeks' gestation were included"", 'single antenatal clinic in India', 'gestational diabetes mellitus in Asian Indian women compared to controls', 'Asian Indian women', 'Fifty women received']","['myoinositol', 'Individualized nutrition counseling with dietary modification and routine antenatal care', 'metformin/insulin', 'myoinositol 1000 mg twice daily; 50 controls did not receive myoinositol']","['Mean duration of myoinositol treatment', 'Glycemic control', 'Efficacy', 'baby weight', 'glycaemia data', 'mean (range) dose of insulin', 'Fasting and postprandial glucose levels']","[{'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C1524069', 'cui_str': 'Indian'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021547', 'cui_str': 'Inositol'}, {'cui': 'C3714365', 'cui_str': 'Nutrition counseling'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C1276362', 'cui_str': 'Routine antenatal care'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021547', 'cui_str': 'Inositol'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}]",100.0,0.0821245,"Secondary outcomes were similar in two groups except baby weight which was higher in controls (p = 0.018). ","[{'ForeName': 'Vidushi', 'Initials': 'V', 'LastName': 'Kulshrestha', 'Affiliation': 'Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, New Delhi, India. Electronic address: drvidushi.kul@gmail.com.'}, {'ForeName': 'Shrey', 'Initials': 'S', 'LastName': 'Balani', 'Affiliation': 'Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, New Delhi, India. Electronic address: shreybalani@gmail.com.'}, {'ForeName': 'Garima', 'Initials': 'G', 'LastName': 'Kachhawa', 'Affiliation': 'Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, New Delhi, India. Electronic address: garimakachhawa2012@gmail.com.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Vanamail', 'Affiliation': 'Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, New Delhi, India. Electronic address: pvanamail@gmail.com.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Kumari', 'Affiliation': 'Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, New Delhi, India. Electronic address: drrajeshkumari@yahoo.com.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, New Delhi, India. Electronic address: jbsharma2000@gmail.com.'}, {'ForeName': 'Neerja', 'Initials': 'N', 'LastName': 'Bhatla', 'Affiliation': 'Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, New Delhi, India. Electronic address: neerja.bhatla07@gmail.com.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2021.02.017'] 2523,33742775,A metabolomic analysis of thiol response for standard and modified N-acetyl cysteine treatment regimens in patients with acetaminophen overdose.,"N-acetylcysteine (NAC) is an antidote to prevent acetaminophen (paracetamol-APAP)-induced acute liver injury (ALI). The 3-bag licensed 20.25 h standard regimen, and a 12 h modified regimen, are used to treat APAP overdose. This study evaluated the redox thiol response and APAP metabolites, in patients with a single APAP overdose treated with either the 20.25 h standard or 12 h modified regimen. We used liquid chromatography tandem mass spectrometry to quantify clinically important oxidative stress biomarkers and APAP metabolites in plasma samples from 45 patients who participated in a randomized controlled trial (SNAP trial). We investigated the time course response of plasma metabolites at predose, 12 h, and 20.25 h post-start of NAC infusion. The results showed that the 12 h modified regimen resulted in a significant elevation of plasma NAC and cysteine concentrations at 12 h post-infusion. We found no significant alteration in the metabolism of APAP, mitochondrial, amino acids, and other thiol biomarkers with the two regimens. We examined APAP and purine metabolism in overdose patients who developed ALI. We showed the major APAP-metabolites and xanthine were significantly higher in patients with ALI. These biomarkers correlated well with alanine aminotransferase activity at admission. Receiver operating characteristic analysis showed that at admission, plasma APAP-metabolites and xanthine concentrations were predictive for ALI. In conclusion, a significantly higher redox thiol response with the modified NAC regimen at 12 h postdose suggests this regimen may produce greater antioxidant efficacy. At baseline, plasma APAP and purine metabolites may be useful biomarkers for early prediction of APAP-induced ALI.",2021,"At baseline, plasma APAP and purine metabolites may be useful biomarkers for early prediction of APAP-induced ALI.","['plasma samples from (n=45) patients who participated in a randomised controlled trial (SNAP Trial', 'patients with a single APAP overdose treated with either the 20.25 hr standard or 12 hr modified regimen', 'Patients With Acetaminophen Overdose', 'overdose patients who developed ALI']","['N-acetylcysteine (NAC', 'Thiol Response for Standard and Modified N-Acetyl Cysteine Treatment Regimens', 'acetaminophen (paracetamol', 'LC-MS/MS']","['redox thiol response and APAP metabolites', 'alanine aminotransferase (ALT) activity', 'antioxidant efficacy', 'plasma APAP-metabolites and xanthine concentrations', 'redox thiol response', 'major APAP-metabolites and xanthine', 'metabolism of APAP, mitochondrial, amino acids, and other thiol biomarkers', 'plasma NAC and cysteine concentrations']","[{'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0572025', 'cui_str': 'Acetaminophen overdose'}, {'cui': 'C2242583', 'cui_str': 'Acute liver injury'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0038734', 'cui_str': 'Sulfhydryls'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0599748', 'cui_str': 'Mass Spectrometry-Mass Spectrometry'}]","[{'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C0038734', 'cui_str': 'Sulfhydryls'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0043314', 'cui_str': 'xanthine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0010654', 'cui_str': 'Cysteine'}]",45.0,0.0481504,"At baseline, plasma APAP and purine metabolites may be useful biomarkers for early prediction of APAP-induced ALI.","[{'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Dear', 'Affiliation': 'Pharmacology, Toxicology, and Therapeutics, Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Mei Li', 'Initials': 'ML', 'LastName': 'Ng', 'Affiliation': 'Cardiovascular Research Institute, National University Health System, Singapore City, Singapore.'}, {'ForeName': 'D Nicholas', 'Initials': 'DN', 'LastName': 'Bateman', 'Affiliation': 'Pharmacology, Toxicology, and Therapeutics, Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Pakkiri', 'Initials': 'P', 'LastName': 'Leroy Sivappiragasam', 'Affiliation': 'Cardiovascular Research Institute, National University Health System, Singapore City, Singapore.'}, {'ForeName': 'Hyungwon', 'Initials': 'H', 'LastName': 'Choi', 'Affiliation': 'Cardiovascular Research Institute, National University Health System, Singapore City, Singapore.'}, {'ForeName': 'Bing Jie', 'Initials': 'BJ', 'LastName': 'Khoo', 'Affiliation': 'Cardiovascular Research Institute, National University Health System, Singapore City, Singapore.'}, {'ForeName': 'Baharudin', 'Initials': 'B', 'LastName': 'Ibrahim', 'Affiliation': 'School of Pharmaceutical Sciences, Universiti Sains Malaysia, Kepala Batas, Malaysia.'}, {'ForeName': 'Chester Lee', 'Initials': 'CL', 'LastName': 'Drum', 'Affiliation': 'Cardiovascular Research Institute, National University Health System, Singapore City, Singapore.'}]",Clinical and translational science,['10.1111/cts.13009'] 2524,33742764,"Safety, tolerability, pharmacokinetics, and pharmacodynamics of a TLR7 agonist prodrug RO6870868 in healthy volunteers.","RO6870868 is an oral prodrug of the toll-like receptor 7 (TLR7) specific agonist, RO6871765. TLR7 agonists augment host immune activity and are in development to treat hepatitis B infection. We evaluated the safety, tolerability, pharmacokinetics (PKs), and pharmacodynamics (PDs) of RO6870868 in a first-in-human, phase I, randomized, single ascending oral dose study in 60 healthy volunteers at 6 dose levels (200-2000 mg). Single oral doses were generally well-tolerated with a predictable safety profile associated with dose-dependent increases in systemic interferon. No serious adverse events (AEs) were reported and no subject withdrew from the study due to an AE. No clinically significant changes were observed in vital signs, electrocardiograms, or laboratory parameters. Following oral RO6870868 doses, plasma RO6871765 concentrations increased rapidly, exhibiting mean terminal half-life ranging 2-6 h across all cohorts, with area under the plasma concentration versus time curve extrapolated to infinity (AUC 0-∞ ) increasing proportionally with dose. A pattern of dose and time-dependent PD activity was demonstrated consistent with engagement of the TLR7 system. Single RO6870868 doses activated components of the TLR innate immune system in a dose-dependent manner with adequate safety and tolerability. Single-dose data in healthy volunteers are useful to evaluate safety, PK, and PD activity of TLR7 agonists and help to guide dose and regimen selection for further trials in patients with chronic hepatitis B.",2021,"No clinically significant changes were observed in vital signs, electrocardiograms or laboratory parameters.","['healthy volunteers', '60\xa0healthy volunteers at 6\xa0dose levels (200\xa0mg-2000\xa0mg', 'patients with chronic hepatitis\xa0B']","['TLR7 agonists', 'TLR7 agonist']","['vital signs, electrocardiograms or laboratory parameters', 'plasma RO6871765 concentrations', 'safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD', 'safety and tolerability', 'Safety, tolerability, pharmacokinetics and pharmacodynamics', 'systemic interferon', 'serious adverse events', 'PD activity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}]","[{'cui': 'C0971207', 'cui_str': 'TLR7 protein, human'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.0716009,"No clinically significant changes were observed in vital signs, electrocardiograms or laboratory parameters.","[{'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Grippo', 'Affiliation': 'Roche Innovation Center, New York, New York, USA.'}, {'ForeName': 'Ilia', 'Initials': 'I', 'LastName': 'Folitar', 'Affiliation': 'Roche Innovation Center, Basel, Switzerland.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Passe', 'Affiliation': 'Roche Innovation Center, New York, New York, USA.'}, {'ForeName': 'Qiudi', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': 'Roche Innovation Center Shanghai, Shanghai, China.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Rodriguez', 'Affiliation': 'Roche Innovation Center, New York, New York, USA.'}, {'ForeName': 'Scott H', 'Initials': 'SH', 'LastName': 'Fettner', 'Affiliation': 'Roche Innovation Center, New York, New York, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Calleja', 'Affiliation': 'Roche Innovation Center, New York, New York, USA.'}]",Clinical and translational science,['10.1111/cts.13016'] 2525,33741520,Yoga improves mitochondrial health and reduces severity of autoimmune inflammatory arthritis: A randomized controlled trial.,"BACKGROUND Oxidative stress (OS) and mitochondrial alterations have been implicated in the pathogenesis of rheumatoid arthritis (RA). Various environmental triggers like air pollutants, smoking, unhealthy social habits and sedentary lifestyle induce OS, which may compromise mitochondrial integrity. This trial was designed to explore the effect of 8-weeks yoga practice on mitochondrial health and disease severity in an active RA group compared with a usual-care control group. METHODS A total of 70 subjects were randomized into two groups: yoga group and non-yoga group. Mitochondrial health was assessed by calculation of mitochondrial DNA copy number (mtDNA-CN), OS markers, mitochondrial activity, mitochondrial membrane potential (ΔΨm), circadian rhythm markers and transcripts associated with mitochondrial integrity: AMPK, TIMP-1, KLOTHO, SIRT-1, and TFAM. Parameters of disease activity and disability quotient were also assessed by disease activity score - erythrocyte sedimentation rate (DAS28-ESR) and health assessment questionnaire-disability index (HAQ-DI), respectively. RESULTS In yoga group, there was a significant upregulation of mtDNA-CN, mitochondrial activity markers, ΔΨm, and transcripts that maintain mitochondrial integrity after 8-weeks of yoga. There was optimization of OS markers, and circadian rhythm markers post 8-weeks practice of yoga. Yoga group participants showed significant improvements in DAS28-ESR (p < 0.05) and HAQ-DI (p < 0.05) over the non-yoga group. CONCLUSION Adoption of yoga by RA patients holds the key to enhance mitochondrial health, improve circadian rhythm markers, OS marker regulation, upregulation of transcripts that maintain mitochondrial integrity, reduce disease activity and its associated consequences on health outcome and hence can be beneficial as an adjunct therapy.",2021,"Yoga group participants showed significant improvements in DAS28-ESR (p<0.05) and HAQ-DI (p<0.05) over the non-yoga group. ",['70 subjects'],"['8-weeks yoga practice', 'yoga group and non-yoga group']","['disease activity score - erythrocyte sedimentation rate (DAS28-ESR) and health assessment questionnaire- disability index (HAQ-DI), respectively', 'disease activity and disability quotient', 'DAS28-ESR (p<0.05) and HAQ-DI', 'Mitochondrial health', 'mitochondrial health', 'mitochondrial health and disease severity', 'autoimmune inflammatory arthritis', 'mitochondrial DNA copy number (mtDNA-CN), OS markers, mitochondrial activity, mitochondrial membrane potential (ΔΨm), circadian rhythm markers and transcripts associated with mitochondrial integrity: AMPK, TIMP-1, KLOTHO, SIRT-1,and TFAM', 'mtDNA-CN, mitochondrial activity markers ,ΔΨm, and transcripts that maintain mitochondrial integrity']",[],"[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0013845', 'cui_str': 'Electron spin resonance measurement'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0102923', 'cui_str': 'ametantrone'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0443146', 'cui_str': 'Autoimmune reaction'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0012929', 'cui_str': 'Mitochondrial DNA'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1720920', 'cui_str': 'Mitochondrial Membrane Potential'}, {'cui': 'C0008810', 'cui_str': 'Circadian rhythm'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C2350345', 'cui_str': 'AMP-Activated Protein Kinase'}, {'cui': 'C0145947', 'cui_str': 'Tissue inhibitor of metalloproteinases 1'}, {'cui': 'C1144173', 'cui_str': 'KL protein, human'}, {'cui': 'C1136177', 'cui_str': 'Silent Mating Type Information Regulator 2-like Proteins'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",70.0,0.137702,"Yoga group participants showed significant improvements in DAS28-ESR (p<0.05) and HAQ-DI (p<0.05) over the non-yoga group. ","[{'ForeName': 'Surabhi', 'Initials': 'S', 'LastName': 'Gautam', 'Affiliation': 'Laboratory for Molecular Reproduction and Genetics, Department of Anatomy, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Kumar', 'Affiliation': 'Department of Rheumatology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Kumar', 'Affiliation': 'Laboratory for Molecular Reproduction and Genetics, Department of Anatomy, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Deeksha', 'Initials': 'D', 'LastName': 'Rana', 'Affiliation': 'Laboratory for Molecular Reproduction and Genetics, Department of Anatomy, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Dada', 'Affiliation': 'Laboratory for Molecular Reproduction and Genetics, Department of Anatomy, All India Institute of Medical Sciences, New Delhi, India. Electronic address: rima_dada@rediffmail.com.'}]",Mitochondrion,['10.1016/j.mito.2021.03.004'] 2526,33741514,Individual versus collective debriefing after interprofessional training course simulation: The randomised DEBRIEF-SIM trial.,"INTRODUCTION Debriefing is a critical phase in simulation-based education that is extremely time-consuming for the instructors. The aim of the study was to assess whether a collective debriefing was non-inferior to an individual debriefing to improve learning outcomes after a simulation session. METHODS This randomised controlled multicentre non-inferiority study included pairs comprising one resident and one student nurse in anaesthesia. Each pair underwent two sessions of a simulated life-threatening emergency held at a 6-week interval. Six participant pairs underwent simulation sessions every half-day of training. The debriefing performed after the first session was either individual (1 debriefing by pair; individual group) or collective (1 debriefing by 6 pairs; collective group). The primary outcome was the evolution of a 34-parameter technical skill score (Delta-TSS-34) between the two simulation sessions. The non-inferiority margin was 5. The change in the Anaesthetists' Non-Technical Skills score (Delta-ANTS), and the debriefing duration per participant pair were secondary endpoint measures. RESULTS Respectively 23 and 21 pairs were included in the collective and individual groups. Delta-TSS-34 was non-inferior in the collective group compared to the individual group (mean intergroup difference [95% confidence interval]: 2.71 [0.44-4.98]). Delta-ANTS did not significantly differ between the two groups (median [interquartile range]: 22 [10-37] versus 25 [17-35], p = 0.57; respectively in the collective and individual groups). The debriefing duration per participant pair was significantly lower in the collective group (10 [10-11] min versus 27 [25-28] min; p < 0.001). CONCLUSION Collective debriefing was non-inferior to individual debriefing to improve learning outcomes after simulation of medical emergencies and allows a significant reduction in the time dedicated to the debriefing.",2021,"CONCLUSION Collective debriefing was non-inferior to individual debriefing to improve learning outcomes after simulation of medical emergencies and allows a significant reduction in the time dedicated to the debriefing.","['23 and 21 pairs were included in the collective and individual groups', 'pairs comprising one resident and one student nurse in anaesthesia']","['Collective debriefing', 'collective debriefing was non-inferior to an individual debriefing']","['evolution of a 34-parameter technical skill score (Delta-TSS-34', 'learning outcomes', 'Delta-TSS-34', 'debriefing duration per participant pair']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0015219', 'cui_str': 'Biological Evolution'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0600327', 'cui_str': 'Toxic shock syndrome'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",,0.232006,"CONCLUSION Collective debriefing was non-inferior to individual debriefing to improve learning outcomes after simulation of medical emergencies and allows a significant reduction in the time dedicated to the debriefing.","[{'ForeName': 'Floriane', 'Initials': 'F', 'LastName': 'Ciceron', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, University Hospital of Besancon, F-25000 Besancon, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Besch', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, University Hospital of Besancon, F-25000 Besancon, France; SFR FED 4234, EA 3920, University of Franche-Comté, F-25000 Besancon, France. Electronic address: gbesch@chu-besancon.fr.'}, {'ForeName': 'Medhi', 'Initials': 'M', 'LastName': 'Benkhadra', 'Affiliation': 'U-Seem Institute and Department of Anaesthesiology and Intensive Care Medicine, University Hospital of Dijon, F-21000 Dijon, France.'}, {'ForeName': 'Jeanne-Antide', 'Initials': 'JA', 'LastName': 'Rouge', 'Affiliation': 'Nurses School Anaesthetist, Healthcare Professionals Training Institute, University Hospital of Besancon, F-25000 Besancon, France.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Dupont', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, University Hospital of Besancon, F-25000 Besancon, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Avena', 'Affiliation': 'U-Seem Institute and Department of Anaesthesiology and Intensive Care Medicine, University Hospital of Dijon, F-21000 Dijon, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Laithier', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, University Hospital of Besancon, F-25000 Besancon, France.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Girard', 'Affiliation': 'U-Seem Institute and Department of Anaesthesiology and Intensive Care Medicine, University Hospital of Dijon, F-21000 Dijon, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Samain', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, University Hospital of Besancon, F-25000 Besancon, France; SFR FED 4234, EA 3920, University of Franche-Comté, F-25000 Besancon, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Pili-Floury', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, University Hospital of Besancon, F-25000 Besancon, France; SFR FED 4234, EA 3920, University of Franche-Comté, F-25000 Besancon, France.'}]","Anaesthesia, critical care & pain medicine",['10.1016/j.accpm.2021.100828'] 2527,33711748,Effects of aromatherapy with essential oil massage on the sleep quality of critical care nurses: A randomized controlled trial.,"The purpose of this study was to explore the effectiveness of an essential oil massage on the sleep quality of the critical care nurses. A randomized controlled trial with single blind was conducted. A total of 112 critical care nurses were recruited. Participants were randomly allocated to either the experimental or control group. Only the experimental group received four sessions consisting of a lavender essential oil massage. The results of this study revealed that the overall subjective sleep quality and objective sleep parameters did not reach a significant difference between the two groups before and after the intervention, but a progressive the subjective sleep quality score reduction was observed in the experimental group. The findings of this study might provide information to critical care nurses who are under high pressure to find the optional alternative way of managing their self-sleep health by employing safe and convenient alternatives through aromatherapy.",2021,"The results of this study revealed that the overall subjective sleep quality and objective sleep parameters did not reach a significant difference between the two groups before and after the intervention, but a progressive the subjective sleep quality score reduction was observed in the experimental group.","['critical care nurses', '112 critical care nurses']","['aromatherapy with essential oil massage', 'lavender essential oil massage', 'essential oil massage']","['sleep quality', 'subjective sleep quality score reduction', 'overall subjective sleep quality and objective sleep parameters']","[{'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0524903', 'cui_str': 'Lavender'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",112.0,0.0307894,"The results of this study revealed that the overall subjective sleep quality and objective sleep parameters did not reach a significant difference between the two groups before and after the intervention, but a progressive the subjective sleep quality score reduction was observed in the experimental group.","[{'ForeName': 'Hsiu-Chin', 'Initials': 'HC', 'LastName': 'Hsu', 'Affiliation': 'Department of Graduate Institute of Health Care, Chang Gung University of Science and Technology, And Assistant Research Fellow, Department of Internal Medicine, Chang Gung Memorial Hospital. 261 Wen-Hau 1st Rd, Kweishan, Tao-Yuan, Taiwan, ROC. Electronic address: hchsu@mail.cgust.edu.tw.'}, {'ForeName': 'Mei-Hsiang', 'Initials': 'MH', 'LastName': 'Lin', 'Affiliation': 'National Taipei University of Nursing and Health Sciences, No.365, Ming-te Road, Peitou District, Taipei City, Taiwan. Electronic address: mhlin5452@gmail.com.'}, {'ForeName': 'Hsiu-Fang', 'Initials': 'HF', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, Chang Gung Medical Foundation, Linkou. Department of Nursing, Chang Gung University of Science & Technology, No.5, Fuxing St., Guishan Dist., Taoyuan City, 333, Taiwan.'}, {'ForeName': 'Chiu-Yen', 'Initials': 'CY', 'LastName': 'Wu', 'Affiliation': 'Department of Cosmetics, Chang Gung University of Science and Technology, Taiwan.'}, {'ForeName': 'Chih-Ting', 'Initials': 'CT', 'LastName': 'Chou', 'Affiliation': 'Department of Nursing New Taipei Municipal Tucheng Hospital, Taiwan.'}, {'ForeName': 'Shu-Fen', 'Initials': 'SF', 'LastName': 'Lin', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, Taiwan.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101358'] 2528,33706065,"Effectiveness of topical ozonated oil in severe osteoarthritis: A randomised, triple-blinded, placebo-controlled study.","BACKGROUND Osteoarthritis is highly prevalent and a common locomotory disorder in the elderly. The treatments aim improves the quality of life. We aimed to evaluate the effectiveness of topical ozonated oil in relieving pain in patients with osteoarthritis. DESIGN A placebo-controlled, triple-blind, randomised controlled trial including osteoarthritis patients older than 50 years. INTERVENTIONS Eighty patients were randomly divided into two groups: treatment (ozonated oil) and placebo (non-ozonated oil). The oils were used twice a day for 60 days. Evaluations were performed using WOMAC (Western Ontario and McMaster Universities) and VAS (visual analogue scale) and laboratory analysis. RESULTS Pain relief was observed in all groups except in the placebo group where patients are diagnosed with severe osteoarthritis (degree 4) (p-value treatment and placebo group: 0.021 and 0.345, respectively). CONCLUSIONS For the first time, the pain relief in patients with severe osteoarthritis was demonstrated by the use of topical ozonated oil.",2021,"RESULTS Pain relief was observed in all groups except in the placebo group where patients are diagnosed with severe osteoarthritis (degree 4)","['patients with severe osteoarthritis', 'osteoarthritis patients older than 50 years', 'patients with osteoarthritis', 'severe osteoarthritis', 'Eighty patients']","['treatment (ozonated oil) and placebo (non-ozonated oil', 'placebo', 'topical ozonated oil']","['quality of life', 'severe osteoarthritis', 'relieving pain', 'Pain relief', 'WOMAC (Western Ontario and McMaster Universities) and VAS (visual analogue scale) and laboratory analysis', 'pain relief']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3816958', 'cui_str': '80'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",80.0,0.178692,"RESULTS Pain relief was observed in all groups except in the placebo group where patients are diagnosed with severe osteoarthritis (degree 4)","[{'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Anzolin', 'Affiliation': 'Graduate Program in Human Aging, University of Passo Fundo, Passo Fundo, Rio Grande do Sul, Brazil. Electronic address: anapaulasordianzolin@gmail.com.'}, {'ForeName': 'Diego da Silva', 'Initials': 'DDS', 'LastName': 'Collares', 'Affiliation': 'Clinical Hospital of Passo Fundo, Passo Fundo, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Tadeu Dos Santos', 'Affiliation': 'Clinical Hospital of Passo Fundo, Passo Fundo, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Adriano', 'Initials': 'A', 'LastName': 'Pasqualotti', 'Affiliation': 'Graduate Program in Human Aging, University of Passo Fundo, Passo Fundo, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Luciana Grazziotin', 'Initials': 'LG', 'LastName': 'Rossato-Grando', 'Affiliation': 'Graduate Program in Bioexperimentation, University of Passo Fundo, Passo Fundo, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Charise Dallazem', 'Initials': 'CD', 'LastName': 'Bertol', 'Affiliation': 'Graduate Program in Human Aging, University of Passo Fundo, Passo Fundo, Rio Grande do Sul, Brazil; College of Pharmacy, University of Passo Fundo, Passo Fundo, Rio Grande do Sul, Brazil. Electronic address: charise@upf.br.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101351'] 2529,33691268,"Multi-study randomised controlled trial to develop, implement and evaluate bra prescription to reduce breast pain and improve quality of life.","BACKGROUND and Purpose: Breast pain is a common condition presented at breast care clinics and bras are often recommended to reduce symptoms, although criteria and pathways for obtaining appropriate bras are limited. This multi-study, randomised controlled trial (RCT) aimed to establish criteria and performance variables to prescribe bras for breast pain patients, to implement this bra prescription, and evaluate whether, compared to standard care alone, the bra prescription improves breast pain and quality of life (QoL). MATERIALS AND METHODS Eighteen breast pain patients from a UK hospital were assigned to standard care or bra prescription groups and completed the study. Bra prescription patients were prescribed a bra to wear every day for eight weeks. Patient Global Impression of Change (PGIC), breast pain intensity, QoL, and adherence were assessed. RESULTS Between-groups there were no differences in baseline breast pain or QoL and no differences in PGIC or breast pain following the intervention. Within-groups, improvements in QoL within bra prescription patients were identified. CONCLUSION This study developed a framework for bra prescription for breast pain patients and the intervention demonstrated improvements in QoL.",2021,there were no differences in baseline breast pain or QoL and no differences in PGIC or breast pain following the intervention.,"['Eighteen breast pain patients from a UK hospital', 'breast pain patients']",[],"['baseline breast pain or QoL', 'PGIC or breast pain', 'QoL', 'breast pain and improve quality of life', 'breast pain and quality of life (QoL', 'Patient Global Impression of Change (PGIC), breast pain intensity, QoL, and adherence']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0024902', 'cui_str': 'Pain of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",[],"[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0024902', 'cui_str': 'Pain of breast'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.112657,there were no differences in baseline breast pain or QoL and no differences in PGIC or breast pain following the intervention.,"[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Sharland', 'Affiliation': 'School of Sport, Health & Exercise Science, University of Portsmouth, Spinnaker Building, Cambridge Road, Portsmouth, Hampshire, PO1 2ER, UK.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Burbage', 'Affiliation': 'School of Sport, Health & Exercise Science, University of Portsmouth, Spinnaker Building, Cambridge Road, Portsmouth, Hampshire, PO1 2ER, UK. Electronic address: jenny.burbage@port.ac.uk.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Noblet', 'Affiliation': 'Breast Services Department, Queen Alexandra Hospital, Southwick Hill Road, Cosham, Portsmouth, Hampshire, PO6 3LY, UK.'}, {'ForeName': 'Avi', 'Initials': 'A', 'LastName': 'Agrawal', 'Affiliation': 'Breast Services Department, Queen Alexandra Hospital, Southwick Hill Road, Cosham, Portsmouth, Hampshire, PO6 3LY, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Wakefield-Scurr', 'Affiliation': 'School of Sport, Health & Exercise Science, University of Portsmouth, Spinnaker Building, Cambridge Road, Portsmouth, Hampshire, PO1 2ER, UK.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101346'] 2530,33721561,70-gene signature as an aid for treatment decisions in early breast cancer: updated results of the phase 3 randomised MINDACT trial with an exploratory analysis by age.,"BACKGROUND The MINDACT trial showed excellent 5-year distant metastasis-free survival of 94·7% (95% CI 92·5-96·2) in patients with breast cancer of high clinical and low genomic risk who did not receive chemotherapy. We present long-term follow-up results together with an exploratory analysis by age. METHODS MINDACT was a multicentre, randomised, phase 3 trial done in 112 academic and community hospitals in nine European countries. Patients aged 18-70 years, with histologically confirmed primary invasive breast cancer (stage T1, T2, or operable T3) with up to three positive lymph nodes, no distant metastases, and a WHO performance status of 0-1 were enrolled and their genomic risk (using the MammaPrint 70-gene signature) and clinical risk (using a modified version of Adjuvant! Online) were determined. Patients with low clinical and low genomic risk results did not receive chemotherapy, and patients with high clinical and high genomic risk did receive chemotherapy (mostly anthracycline-based or taxane-based, or a combination thereof). Patients with discordant risk results (ie, patients with high clinical risk but low genomic risk, and those with low clinical risk but high genomic risk) were randomly assigned (1:1) to receive chemotherapy or not based on either the clinical risk or the genomic risk. Randomisation was done centrally and used a minimisation technique that was stratified by institution, risk group, and clinical-pathological characteristics. Treatment allocation was not masked. The primary endpoint was to test whether the distant metastasis-free survival rate at 5 years in patients with high clinical risk and low genomic risk not receiving chemotherapy had a lower boundary of the 95% CI above the predefined non-inferiority boundary of 92%. In the primary test population of patients with high clinical risk and low genomic risk who adhered to the treatment allocation of no chemotherapy and had no change in risk post-enrolment. Here, we present updated follow-up as well as an exploratory analysis of a potential age effect (≤50 years vs >50 years) and an analysis by nodal status for patients with hormone receptor-positive and HER2-negative disease. These analyses were done in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT00433589, and the European Clinical Trials database, EudraCT2005-002625-31. Recruitment is complete and further long-term follow-up is ongoing. FINDINGS Between Feb 8, 2007, and July 11, 2011, 6693 patients were enrolled. On Feb 26, 2020, median follow-up was 8·7 years (IQR 7·8-9·7). The updated 5-year distant metastasis-free survival rate for patients with high clinical risk and low genomic risk receiving no chemotherapy (primary test population, n=644) was 95·1% (95% CI 93·1-96·6), which is above the predefined non-inferiority boundary of 92%, supporting the previous analysis and proving MINDACT as a positive de-escalation trial. Patients with high clinical risk and low genomic risk were randomly assigned to receive chemotherapy (n=749) or not (n=748); this was the intention-to-treat population. The 8-year estimates for distant metastasis-free survival in the intention-to-treat population were 92·0% (95% CI 89·6-93·8) for chemotherapy versus 89·4% (86·8-91·5) for no chemotherapy (hazard ratio 0·66; 95% CI 0·48-0·92). An exploratory analysis confined to the subset of patients with hormone receptor-positive, HER2-negative disease (1358 [90.7%] of 1497 randomly assigned patients, of whom 676 received chemotherapy and 682 did not) shows different effects of chemotherapy administration on 8-year distant metastasis-free survival according to age: 93·6% (95% CI 89·3-96·3) with chemotherapy versus 88·6% (83·5-92·3) without chemotherapy in 464 women aged 50 years or younger (absolute difference 5·0 percentage points [SE 2·8, 95% CI -0·5 to 10·4]) and 90·2% (86·8-92·7) versus 90·0% (86·6-92·6) in 894 women older than 50 years (absolute difference 0·2 percentage points [2·1, -4·0 to 4·4]). The 8-year distant metastasis-free survival in the exploratory analysis by nodal status in these patients was 91·7% (95% CI 88·1-94·3) with chemotherapy and 89·2% (85·2-92·2) without chemotherapy in 699 node-negative patients (absolute difference 2·5 percentage points [SE 2·3, 95% CI -2·1 to 7·2]) and 91·2% (87·2-94·0) versus 89·9% (85·8-92·8) for 658 patients with one to three positive nodes (absolute difference 1·3 percentage points [2·4, -3·5 to 6·1]). INTERPRETATION With a more mature follow-up approaching 9 years, the 70-gene signature shows an intact ability of identifying among women with high clinical risk, a subgroup, namely patients with a low genomic risk, with an excellent distant metastasis-free survival when treated with endocrine therapy alone. For these women the magnitude of the benefit from adding chemotherapy to endocrine therapy remains small (2·6 percentage points) and is not enhanced by nodal positivity. However, in an underpowered exploratory analysis this benefit appears to be age-dependent, as it is only seen in women younger than 50 years where it reaches a clinically relevant threshold of 5 percentage points. Although, possibly due to chemotherapy-induced ovarian function suppression, it should be part of informed, shared decision making. Further study is needed in younger women, who might need reinforced endocrine therapy to forego chemotherapy. FUNDING European Commission Sixth Framework Programme.",2021,The primary endpoint was to test whether the distant metastasis-free survival rate at 5 years in patients with high clinical risk and low genomic risk not receiving chemotherapy had a lower boundary of the 95% CI above the predefined non-inferiority boundary of 92%.,"['patients with hormone receptor-positive, HER2-negative disease (1358 [90.7%] of 1497 randomly assigned patients, of whom 676 received', 'patients with hormone receptor-positive and HER2-negative disease', 'Patients with high clinical risk and low genomic risk', 'women younger than 50 years', '6693 patients were enrolled', 'younger women, who might need reinforced endocrine therapy to forego chemotherapy', 'patients with breast cancer of high clinical and low genomic risk who did not receive chemotherapy', '464 women aged 50 years or younger (absolute difference 5·0 percentage points [SE 2·8, 95% CI -0·5 to 10·4]) and 90·2% (86·8-92·7) versus 90·0% (86·6-92·6) in 894 women older than 50 years (absolute difference 0·2 percentage points [2·1, -4·0 to 4·4', 'Patients aged 18-70 years, with histologically confirmed primary invasive breast cancer (stage T1, T2, or operable T3) with up to three positive lymph nodes, no distant metastases, and a WHO performance status of 0-1 were enrolled and their genomic risk (using the MammaPrint 70-gene signature) and clinical risk (using a modified version of Adjuvant', 'early breast cancer', 'Patients with low clinical and low genomic risk results did not receive chemotherapy, and patients with high clinical and high genomic risk did receive', 'Between Feb 8, 2007, and July 11, 2011', 'Patients with discordant risk results (ie, patients with high clinical risk but low genomic risk, and those with low clinical risk but high genomic risk', '112 academic and community hospitals in nine European countries', 'patients with high clinical risk and low genomic risk receiving no chemotherapy (primary test population, n=644', 'patients with high clinical risk and low genomic risk']","['chemotherapy versus 88·6% (83·5-92·3) without chemotherapy', 'endocrine therapy alone', 'chemotherapy (mostly anthracycline-based or taxane-based, or a combination thereof', 'chemotherapy']","['8-year distant metastasis-free survival', 'distant metastasis-free survival rate', '5-year distant metastasis-free survival rate', '5-year distant metastasis-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0853879', 'cui_str': 'Invasive carcinoma of breast'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0215136', 'cui_str': 'taxane'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",6693.0,0.43692,The primary endpoint was to test whether the distant metastasis-free survival rate at 5 years in patients with high clinical risk and low genomic risk not receiving chemotherapy had a lower boundary of the 95% CI above the predefined non-inferiority boundary of 92%.,"[{'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Piccart', 'Affiliation': 'Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium. Electronic address: martine.piccart@bordet.be.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': ""van 't Veer"", 'Affiliation': 'UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA.'}, {'ForeName': 'Coralie', 'Initials': 'C', 'LastName': 'Poncet', 'Affiliation': 'European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium.'}, {'ForeName': 'Josephine M N', 'Initials': 'JMN', 'LastName': 'Lopes Cardozo', 'Affiliation': 'European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium.'}, {'ForeName': 'Suzette', 'Initials': 'S', 'LastName': 'Delaloge', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Pierga', 'Affiliation': 'Institut Curie, Paris & Saint-Cloud, Université de Paris, Paris, France.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vuylsteke', 'Affiliation': 'CHU Site Sainte-Elisabeth-UCL Namur, Namur, Belgium.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Brain', 'Affiliation': 'Institut Curie-Hôpital Rene Huguenin, Saint-Cloud, France.'}, {'ForeName': 'Suzan', 'Initials': 'S', 'LastName': 'Vrijaldenhoven', 'Affiliation': 'Noordwest Ziekenhuisgroep, Alkmaar, Netherlands.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Neijenhuis', 'Affiliation': 'Alrijne Ziekenhuis, Leiderdorp, Netherlands.'}, {'ForeName': 'Sylvian', 'Initials': 'S', 'LastName': 'Causeret', 'Affiliation': 'Centre George-Francois-Leclerc, Dijon, France.'}, {'ForeName': 'Tineke J', 'Initials': 'TJ', 'LastName': 'Smilde', 'Affiliation': ""Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, Netherlands.""}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Viale', 'Affiliation': 'University of Milan, Milan, Italy; European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Annuska M', 'Initials': 'AM', 'LastName': 'Glas', 'Affiliation': 'Agendia, Amsterdam, Netherlands.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Delorenzi', 'Affiliation': 'Swiss Institute of Bioinformatics and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Sotiriou', 'Affiliation': 'Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Isabel T', 'Initials': 'IT', 'LastName': 'Rubio', 'Affiliation': 'Clinica Universidad de Navarra, Madrid, Spain.'}, {'ForeName': 'Sherko', 'Initials': 'S', 'LastName': 'Kümmel', 'Affiliation': 'Breast Unit, Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Zoppoli', 'Affiliation': 'Gruppo Oncologico Italiano di Ricerca Clinica, Università degli Studi di Genova and IRCCS Ospedale Policlinico San Martino, Genoa, Italy.'}, {'ForeName': 'Alastair M', 'Initials': 'AM', 'LastName': 'Thompson', 'Affiliation': 'Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Matos', 'Affiliation': 'Institute of Oncology, Ljubljana, Slovenia.'}, {'ForeName': 'Khalil', 'Initials': 'K', 'LastName': 'Zaman', 'Affiliation': 'Lausanne University Hospital CHUV, Lausanne, Switzerland.'}, {'ForeName': 'Florentine', 'Initials': 'F', 'LastName': 'Hilbers', 'Affiliation': 'Breast International Group Headquarters, Brussels, Belgium.'}, {'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Fumagalli', 'Affiliation': 'Breast International Group Headquarters, Brussels, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ravdin', 'Affiliation': 'University of Texas Health Sciences Center, San Antonio, TX, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Knox', 'Affiliation': 'Europa Donna-European Breast Cancer Coalition, Milan, Italy.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Tryfonidis', 'Affiliation': 'European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Peric', 'Affiliation': 'European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Meulemans', 'Affiliation': 'European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Bogaerts', 'Affiliation': 'European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Cardoso', 'Affiliation': 'Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal.'}, {'ForeName': 'Emiel J T', 'Initials': 'EJT', 'LastName': 'Rutgers', 'Affiliation': 'Netherlands Cancer Institute, Amsterdam, Netherlands.'}]",The Lancet. Oncology,['10.1016/S1470-2045(21)00007-3'] 2531,33721560,"Adjuvant atezolizumab versus observation in muscle-invasive urothelial carcinoma (IMvigor010): a multicentre, open-label, randomised, phase 3 trial.","BACKGROUND Despite standard curative-intent treatment with neoadjuvant cisplatin-based chemotherapy, followed by radical surgery in eligible patients, muscle-invasive urothelial carcinoma has a high recurrence rate and no level 1 evidence for adjuvant therapy. We aimed to evaluate atezolizumab as adjuvant therapy in patients with high-risk muscle-invasive urothelial carcinoma. METHOD In the IMvigor010 study, a multicentre, open-label, randomised, phase 3 trial done in 192 hospitals, academic centres, and community oncology practices across 24 countries or regions, patients aged 18 years and older with histologically confirmed muscle-invasive urothelial carcinoma and an Eastern Cooperative Oncology Group performance status of 0, 1, or 2 were enrolled within 14 weeks after radical cystectomy or nephroureterectomy with lymph node dissection. Patients had ypT2-4a or ypN+ tumours following neoadjuvant chemotherapy or pT3-4a or pN+ tumours if no neoadjuvant chemotherapy was received. Patients not treated with neoadjuvant chemotherapy must have been ineligible for or declined cisplatin-based adjuvant chemotherapy. No post-surgical radiotherapy or previous adjuvant chemotherapy was allowed. Patients were randomly assigned (1:1) using a permuted block (block size of four) method and interactive voice-web response system to receive 1200 mg atezolizumab given intravenously every 3 weeks for 16 cycles or up to 1 year, whichever occurred first, or to observation. Randomisation was stratified by previous neoadjuvant chemotherapy use, number of lymph nodes resected, pathological nodal status, tumour stage, and PD-L1 expression on tumour-infiltrating immune cells. The primary endpoint was disease-free survival in the intention-to-treat population. Safety was assessed in patients who either received at least one dose of atezolizumab or had at least one post-baseline safety assessment. This trial is registered with ClinicalTrials.gov, NCT02450331, and is ongoing but not recruiting patients. FINDINGS Between Oct 5, 2015, and July 30, 2018, we enrolled 809 patients, of whom 406 were assigned to the atezolizumab group and 403 were assigned to the observation group. Median follow-up was 21·9 months (IQR 13·2-29·8). Median disease-free survival was 19·4 months (95% CI 15·9-24·8) with atezolizumab and 16·6 months (11·2-24·8) with observation (stratified hazard ratio 0·89 [95% CI 0·74-1·08]; p=0·24). The most common grade 3 or 4 adverse events were urinary tract infection (31 [8%] of 390 patients in the atezolizumab group vs 20 [5%] of 397 patients in the observation group), pyelonephritis (12 [3%]) vs 14 [4%]), and anaemia (eight [2%] vs seven [2%]). Serious adverse events occurred in 122 (31%) patients who received atezolizumab and 71 (18%) who underwent observation. 63 (16%) patients who received atezolizumab had a treatment-related grade 3 or 4 adverse event. One treatment-related death, due to acute respiratory distress syndrome, occurred in the atezolizumab group. INTERPRETATION To our knowledge, IMvigor010 is the largest, first-completed phase 3 adjuvant study to evaluate the role of a checkpoint inhibitor in muscle-invasive urothelial carcinoma. The trial did not meet its primary endpoint of improved disease-free survival in the atezolizumab group over observation. Atezolizumab was generally tolerable, with no new safety signals; however, higher frequencies of adverse events leading to discontinuation were reported than in metastatic urothelial carcinoma studies. These data do not support the use of adjuvant checkpoint inhibitor therapy in the setting evaluated in IMvigor010 at this time. FUNDING F Hoffmann-La Roche/Genentech.",2021,"One treatment-related death, due to acute respiratory distress syndrome, occurred in the atezolizumab group. ","['patients with high-risk muscle-invasive urothelial carcinoma', 'muscle-invasive urothelial carcinoma (IMvigor010', 'enrolled 809 patients, of whom 406 were assigned to the', 'eligible patients, muscle-invasive urothelial carcinoma', 'Patients had ypT2-4a or ypN+ tumours following neoadjuvant chemotherapy or pT3-4a or pN+ tumours if no neoadjuvant chemotherapy was received', 'Between Oct 5, 2015, and July 30, 2018', '192 hospitals, academic centres, and community oncology practices across 24 countries or regions, patients aged 18 years and older with histologically confirmed muscle-invasive urothelial carcinoma and an Eastern Cooperative Oncology Group performance status of 0, 1, or 2 were enrolled within 14 weeks after']","['permuted block (block size of four) method and interactive voice-web response system to receive 1200 mg atezolizumab', 'neoadjuvant cisplatin-based chemotherapy, followed by radical surgery', 'cisplatin-based adjuvant chemotherapy', 'Adjuvant atezolizumab', 'radical cystectomy or nephroureterectomy with lymph node dissection', 'neoadjuvant chemotherapy', 'atezolizumab', 'Atezolizumab']","['pyelonephritis', 'anaemia', 'urinary tract infection', 'disease-free survival', 'Safety', 'Median disease-free survival', 'Serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332393', 'cui_str': 'pT3 category'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C0027732', 'cui_str': 'Nephroureterectomy'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}]","[{'cui': 'C0034186', 'cui_str': 'Pyelonephritis'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",809.0,0.269397,"One treatment-related death, due to acute respiratory distress syndrome, occurred in the atezolizumab group. ","[{'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Bellmunt', 'Affiliation': 'Beth Israel Deaconess Medical Center and PSMAR-IMIM Lab, Harvard Medical School, Boston, MA, USA. Electronic address: jbellmun@bidmc.harvard.edu.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'Robert H Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Jürgen E', 'Initials': 'JE', 'LastName': 'Gschwend', 'Affiliation': 'Department of Urology, Rechts der Isar Hospital, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Albers', 'Affiliation': 'Department of Urology, Medical Faculty, Heinrich-Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Oudard', 'Affiliation': 'Georges Pompidou European Hospital, University of Paris, Paris, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Castellano', 'Affiliation': 'Medical Oncology Department University Hospital 12 de Octubre, CIBER-ONC, Madrid, Spain.'}, {'ForeName': 'Siamak', 'Initials': 'S', 'LastName': 'Daneshmand', 'Affiliation': 'Department of Urology, USC Norris Comprehensive Cancer Center, Los Angeles, CA, USA.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Nishiyama', 'Affiliation': 'Department of Urology, Faculty of Medicine University of Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Majchrowicz', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Viraj', 'Initials': 'V', 'LastName': 'Degaonkar', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Mariathasan', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Petros', 'Initials': 'P', 'LastName': 'Grivas', 'Affiliation': 'Division of Medical Oncology, University of Washington, Seattle, WA, USA; Division of Medical Oncology, Seattle Cancer Care Alliance, Seattle, WA, USA; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Drakaki', 'Affiliation': 'Division of Hematology/Oncology, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': ""O'Donnell"", 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Rosenberg', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medical Oncology, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Geynisman', 'Affiliation': 'Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Petrylak', 'Affiliation': 'Department of Urology, Yale Cancer Center, New Haven, CT, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Hoffman-Censits', 'Affiliation': 'Department of Medical Oncology and Department of Urology, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Bedke', 'Affiliation': 'Department of Urology, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Arash Rezazadeh', 'Initials': 'AR', 'LastName': 'Kalebasty', 'Affiliation': 'Department of Hematology/Oncology, University of California, Irvine, Irvine, CA, USA.'}, {'ForeName': 'Yousef', 'Initials': 'Y', 'LastName': 'Zakharia', 'Affiliation': 'Holden Comprehensive Cancer Center, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Michiel S', 'Initials': 'MS', 'LastName': 'van der Heijden', 'Affiliation': 'Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'Englander Institute for Precision Medicine, Weill Cornell Medicine, New York-Presbyterian, New York, NY, USA.'}, {'ForeName': 'Nicole N', 'Initials': 'NN', 'LastName': 'Davarpanah', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': ""Barts Cancer Institute, Queen Mary University of London, St Bartholomew's Hospital, London, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(21)00004-8'] 2532,33731305,The Cost-Effectiveness of Palliative Care: Insights from the PAL-HF Trial.,"BACKGROUND In a randomized control trial, Palliative Care in Heart Failure (PAL-HF) improved heart failure-related quality of life, though cost-effectiveness remains unknown. The aim of this study was to evaluate the cost-effectiveness of the PAL-HF trial, which provided outpatient palliative care to patients with advanced heart failure. METHODS AND RESULTS Outcomes for usual care and PAL-HF strategies were compared using a Markov cohort model over 36 months from a payer perspective. The model parameters were informed by PAL-HF trial data and supplemented with meta-analyses and Medicare administrative data. Outcomes included hospitalization, place of death, Medicare expenditures, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios. Simulated mortality rates were the same for PAL-HF and usual care cohorts, at 89.7% at 36 months. In the base case analysis, the PAL-HF intervention resulted in an incremental gain of 0.03 QALYs and an incremental cost of $964 per patient for an incremental cost-effectiveness ratio of $29,041 per QALY. In 1-way sensitivity analyses, an intervention cost of up to $140 per month is cost effective at $50,000 per QALY. Of 1000 simulations, the PC intervention had a 66.1% probability of being cost effective at a $50,000 willingness-to-pay threshold assuming no decrease in hospitalization. In a scenario analysis, PAL-HF decreased payer spending through reductions in noncardiovascular hospitalizations. CONCLUSIONS These results from this single-center trial are encouraging that palliative care for advanced heart failure is an economically attractive intervention. Confirmation of these findings in larger multicenter trials will be an important part of developing the evidence to support more widespread implementation of the PAL-HF palliative care intervention.",2021,"Of 1000 simulations, the PC intervention had a 66.1% probability of being cost-effective at $50,000 willingness-to-pay threshold assuming no reduction in hospitalization.",['patients with advanced heart failure'],"['PC intervention', 'PAL-HF intervention']","['mortality rates', 'hospitalization, place of death, Medicare expenditures, quality adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICER', 'probability of being cost-effective', 'cost-effectiveness', 'hospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0421611', 'cui_str': 'Place of death'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0998582,"Of 1000 simulations, the PC intervention had a 66.1% probability of being cost-effective at $50,000 willingness-to-pay threshold assuming no reduction in hospitalization.","[{'ForeName': 'Brystana G', 'Initials': 'BG', 'LastName': 'Kaufman', 'Affiliation': 'Margolis Center for Health Policy, Duke University, Durham, North Carolina. Electronic address: Brystana.kaufman@duke.edu.'}, {'ForeName': 'Bradi B', 'Initials': 'BB', 'LastName': 'Granger', 'Affiliation': 'Margolis Center for Health Policy, Duke University, Durham, North Carolina; School of Nursing, Duke University, Durham, North Carolina.'}, {'ForeName': 'Jie-Lena', 'Initials': 'JL', 'LastName': 'Sun', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Sanders', 'Affiliation': 'Margolis Center for Health Policy, Duke University, Durham, North Carolina; Department of Population Health Sciences, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Donald H', 'Initials': 'DH', 'LastName': 'Taylor', 'Affiliation': 'Margolis Center for Health Policy, Duke University, Durham, North Carolina; Sanford School of Public Policy, Duke University, Durham, North Carolina.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Haider', 'Initials': 'H', 'LastName': 'Warraich', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Fiuzat', 'Affiliation': 'Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Steinhauser', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Tulsky', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Joseph G', 'Initials': 'JG', 'LastName': 'Rogers', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': ""O'Connor"", 'Affiliation': 'Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}]",Journal of cardiac failure,['10.1016/j.cardfail.2021.02.019'] 2533,33734306,Intravitreal Aflibercept Injection vs Sham as Prophylaxis Against Conversion to Exudative Age-Related Macular Degeneration in High-risk Eyes: A Randomized Clinical Trial.,"Importance Anti-vascular endothelial growth factor (VEGF) agents may provide a prophylactic effect in high-risk eyes with intermediate dry age-related macular degeneration (AMD) against conversion to exudative AMD (eAMD), lowering the risk of vision loss. Objective To evaluate intravitreal aflibercept injection (IAI) as prophylaxis against the conversion to eAMD in high-risk eyes at 24 months. Design, Setting, and Participants This single-masked, sham-controlled, randomized clinical trial performed at 4 US clinical sites enrolled patients with intermediate AMD in 1 eye (study eye), defined as presence of more than 10 medium drusen (≥63 to <125 μm), at least 1 large druse (≥125 μm), and/or retinal pigmentary changes, and eAMD in the fellow eye. Patients were treated from June 23, 2015, to March 13, 2019. Interventions Intravitreal aflibercept injection (2 mg) or sham quarterly injection for 24 months (1:1 randomization). Main Outcomes and Measures The primary end point was the proportion of patients with conversion to eAMD at month 24 characterized by development of choroidal neovascularization, as assessed by leakage on fluorescein angiography and fluid on spectral-domain optical coherence tomography by an independent masked reading center. Results Of 128 patients enrolled, 127 (63 in the IAI group and 64 in the sham group) were included in the primary analysis (68 men [53.5%]; mean [SD] age, 76.5 [8.1] years). Baseline demographic and clinical characteristics were balanced between the groups. By month 24, 6 patients (9.5%) in the IAI group and 7 (10.9%) in the sham group developed eAMD (P = .98). Patients with a history of eAMD for longer than 2 years in their fellow eye at baseline showed a lower rate of conversion to eAMD in the study eye compared with those with a history of eAMD for 2 years or less in the fellow eye. Safety was consistent with previous studies involving intravitreal anti-VEGF injections. Conclusions and Relevance In this evaluation of quarterly anti-VEGF exposure as prophylaxis to reduce conversion of eyes with high-risk dry AMD to eAMD, the rates of conversion were not lower in the IAI group compared with the sham treatment group at month 24. Understanding the mechanism of conversion to eAMD and therapies that could prevent this event remains an important unmet need. Trial Registration ClinicalTrials.gov Identifier: NCT02462889.",2021,Patients with a history of eAMD for longer than 2 years in their fellow eye at baseline showed a lower rate of conversion to eAMD in the study eye compared with those with a history of eAMD for 2 years or less in the fellow eye.,"['high-risk eyes with intermediate dry age-related macular degeneration (AMD) against conversion to exudative AMD (eAMD', 'Patients were treated from June 23, 2015, to March 13, 2019', '128 patients enrolled, 127 (63 in the IAI group and 64 in the sham group) were included in the primary analysis (68 men [53.5%]; mean [SD] age, 76.5 [8.1] years', 'high-risk eyes at 24 months', 'enrolled patients with intermediate AMD in 1 eye (study eye), defined as presence of more than 10 medium drusen (≥63 to <125 μm), at least 1 large druse (≥125 μm), and/or retinal pigmentary changes, and eAMD in the fellow eye', 'High-risk Eyes']","['intravitreal aflibercept injection (IAI', 'Intravitreal aflibercept injection', 'Intravitreal Aflibercept Injection vs Sham', 'Importance\n\n\nAnti-vascular endothelial growth factor (VEGF) agents']","['proportion of patients with conversion to eAMD', 'rates of conversion', 'eAMD', 'rate of conversion to eAMD']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C3888461', 'cui_str': 'Dry age-related macular degeneration'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0311438', 'cui_str': 'Exudative'}, {'cui': 'C0017921', 'cui_str': 'Generalized glycogenosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0035312', 'cui_str': 'Retinal drusen'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1260926', 'cui_str': 'Abnormal pigmentation'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0311438', 'cui_str': 'Exudative'}, {'cui': 'C0017921', 'cui_str': 'Generalized glycogenosis'}]",128.0,0.372482,Patients with a history of eAMD for longer than 2 years in their fellow eye at baseline showed a lower rate of conversion to eAMD in the study eye compared with those with a history of eAMD for 2 years or less in the fellow eye.,"[{'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Heier', 'Affiliation': 'Ophthalmic Consultants of Boston, Boston, Massachusetts.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Brown', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas.'}, {'ForeName': 'Sumit P', 'Initials': 'SP', 'LastName': 'Shah', 'Affiliation': 'New Jersey Retina, New Brunswick, New Jersey.'}, {'ForeName': 'Namrata', 'Initials': 'N', 'LastName': 'Saroj', 'Affiliation': 'All Eyes Consulting, LLC, New York, New York.'}, {'ForeName': 'Sabin', 'Initials': 'S', 'LastName': 'Dang', 'Affiliation': 'The Retina Institute, St Louis, Missouri.'}, {'ForeName': 'Nadia K', 'Initials': 'NK', 'LastName': 'Waheed', 'Affiliation': 'Boston Image Reading Center, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Retina Consultants of America, Blanton Eye Institute, Houston Methodist Hospital, Weill Cornell Medical College, Houston, Texas.'}, {'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Prenner', 'Affiliation': 'Department of Ophthalmology, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Boyer', 'Affiliation': 'Retina Vitreous Associates Medical Group, Los Angeles, California.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2021.0221'] 2534,33706052,Evaluation of efficacy and safety of intraoral negative air pressure device in adults with obstructive sleep apnea in Taiwan.,"OBJECTIVE Through this study, we aimed to evaluate the efficacy and safety of the intraoral negative air pressure device (iNAP) in patients with moderate to severe obstructive sleep apnea (OSA) in Taiwan. DESIGN Crossover and evaluator-blind, self-control design. SETTING Academic medical center. PATIENTS A total of 35 patients provided their consent to participate in this study; however, only 34 patients (30 men [87.5%] and four women [12.50%]) were eligible and randomized to the Clinical Cohort and Safety Cohort. The mean age of the 32 evaluable patients (PE cohort) was 47.4 ± 11.2 years, and their mean BMI was 26.5 ± 3.2 kg/m 2 . MEASUREMENTS AND RESULTS The clinical response rate was 75% (24/32 patients) comparing the treatment polysomnography values to the baseline values. The mean (±standard deviation) baseline apnea-hypopnea index was 32.0 ± 11.3 events/h, which decreased significantly to 8.7 ± 9.4 events/h. Mo medical device-related adverse event or serious adverse event occurred during the study period. CONCLUSIONS Compared with the previous oral pressure therapy device, the iNAP treated approximately three-fourths of the patients with OSA and had a superior comfort and safety profile. Thus, the iNAP device could be an alternative treatment solution for patients with moderate to severe OSA.",2021,The clinical response rate was 75% (24/32 patients) comparing the treatment polysomnography values to the baseline values.,"['A total of 35 patients provided their consent to participate in this study; however, only 34 patients (30 men [87.5%] and four women [12.50%]) were eligible and randomized to the Clinical Cohort and Safety Cohort', 'adults with obstructive sleep apnea in Taiwan', 'patients with moderate to severe obstructive sleep apnea (OSA) in Taiwan', 'The mean age of the 32 evaluable patients (PE cohort) was 47.4\xa0±\xa011.2 years, and their mean BMI was 26.5\xa0±\xa03.2\xa0kg', 'patients with moderate to severe OSA', 'Academic medical center']","['intraoral negative air pressure device (iNAP', 'intraoral negative air pressure device']","['clinical response rate', 'superior comfort and safety profile', 'efficacy and safety', 'mean (±standard deviation) baseline apnea-hypopnea index']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517896', 'cui_str': '87.5'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517531', 'cui_str': '11.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C0442119', 'cui_str': 'Intraoral approach'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001876', 'cui_str': 'Air pressure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}]",35.0,0.042295,The clinical response rate was 75% (24/32 patients) comparing the treatment polysomnography values to the baseline values.,"[{'ForeName': 'Ching-Yuan', 'Initials': 'CY', 'LastName': 'Cheng', 'Affiliation': 'Sleep Center, Thoracic Medicine, Shin Kong Memorial Wu Ho-Su Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chia-Chi', 'Initials': 'CC', 'LastName': 'Chen', 'Affiliation': 'Sleep Center, Thoracic Medicine, Shin Kong Memorial Wu Ho-Su Hospital, Taipei, Taiwan; Department of Biomedical Sciences & Engineering, National Central University, Taoyuan, Taiwan.'}, {'ForeName': 'Men-Tzung', 'Initials': 'MT', 'LastName': 'Lo', 'Affiliation': 'Department of Biomedical Sciences & Engineering, National Central University, Taoyuan, Taiwan.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Guilleminault', 'Affiliation': 'Stanford University Sleep Medicine Division, Redwood City, CA, USA.'}, {'ForeName': 'Chia-Mo', 'Initials': 'CM', 'LastName': 'Lin', 'Affiliation': 'Sleep Center, Thoracic Medicine, Shin Kong Memorial Wu Ho-Su Hospital, Taipei, Taiwan; Graduate Institute of Biomedical and Pharmaceutical Science, Fu-Jen Catholic University, New Taipei City, Taiwan. Electronic address: aminus64@gmail.com.'}]",Sleep medicine,['10.1016/j.sleep.2021.02.013'] 2535,33736920,Active-controlled phase III study of an egg-cultivated quadrivalent inactivated split-virion influenza vaccine (GC3110A) in healthy Korean children aged 6-35 months.,"The inactivated trivalent influenza vaccine (TIV) offers limited protection when two influenza B lineages co-circulate or when there is a vaccine mismatch (i.e., discordance in the predominant circulating B strain and WHO-recommended B strain). Inactivated quadrivalent influenza vaccine (QIV) may reduce the burden of influenza. Here, we report the results of a phase 3 clinical trial that evaluated the immunogenicity and safety of a novel QIV, GC3110A, in Korean children aged 6-35 months, which has been approved and is currently in use in Korea. The study involved two parts. In Part 1, the safety of GC3110A was evaluated in 10 subjects. After none of the subjects reported grade 3 adverse events (AEs), we proceeded to Part 2. Part 2 was a randomized, double-blind, multicenter phase 3 trial wherein we compared the immunogenicity and safety of GC3110A with those of a licensed control TIV. Immunogenicity was evaluated by measuring hemagglutination inhibition titers. The 200 participants enrolled in Part 2 were randomized in a 4:1 ratio to receive GC3110A or control TIV. The study vaccine group met both primary (i.e., the lower limit of 95% confidence interval [CI] of the seroconversion rate exceeds 40% for four strains) and secondary (i.e., the lower limit of 95% CI of the seroprotection rate exceeds 70% for four strains) immunogenicity endpoints. There was no significant between-group difference in the seroconversion rate, seroprotection rate, and geometric mean titer for the shared strains. However, the study vaccine group demonstrated significantly higher immunity for the additional strain B/Yamagata. In the safety analysis, there was no significant between-group difference in the proportion of participants with solicited local AEs, solicited systemic AEs, and unsolicited AEs. In conclusion, the results indicate that GC3110A has comparable immunogenicity and safety to those of TIV. Clinical Trial Registry Number: NCT03285997.",2021,"There was no significant between-group difference in the seroconversion rate, seroprotection rate, and geometric mean titer for the shared strains.","['10 subjects', 'healthy Korean children aged 6-35\xa0months', 'Korean children aged 6-35\xa0months', '200 participants enrolled in Part 2']","['Inactivated quadrivalent influenza vaccine (QIV', 'inactivated trivalent influenza vaccine (TIV', 'novel QIV, GC3110A', 'GC3110A or control TIV', 'GC3110A', 'egg-cultivated quadrivalent inactivated split-virion influenza vaccine (GC3110A']","['Immunogenicity', 'hemagglutination inhibition titers', 'immunogenicity and safety', 'seroconversion rate', 'safety of GC3110A', 'seroconversion rate, seroprotection rate, and geometric mean titer', 'seroprotection rate']","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C4318638', 'cui_str': 'Quadrivalent Influenza Vaccine'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0042760', 'cui_str': 'Virion'}]","[{'cui': 'C0018904', 'cui_str': 'Hemagglutination inhibition assay'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",200.0,0.371371,"There was no significant between-group difference in the seroconversion rate, seroprotection rate, and geometric mean titer for the shared strains.","[{'ForeName': 'Ui Yoon', 'Initials': 'UY', 'LastName': 'Choi', 'Affiliation': ""Department of Pediatrics, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 1021, Tongil-ro, Eunpyeong-gu, Seoul, 03312, Republic of Korea. Electronic address: uiyoon@catholic.ac.kr.""}, {'ForeName': 'Ki Hwan', 'Initials': 'KH', 'LastName': 'Kim', 'Affiliation': ""Department of Pediatrics, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. Electronic address: poohwa99@gmail.com.""}, {'ForeName': 'Kyung Yil', 'Initials': 'KY', 'LastName': 'Lee', 'Affiliation': ""Department of Pediatrics, Daejeon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. Electronic address: leekyungyil@catholic.ac.kr.""}, {'ForeName': 'Jong-Hyun', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': ""Department of Pediatrics, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. Electronic address: jh00mn@catholic.ac.kr.""}, {'ForeName': 'Chun Soo', 'Initials': 'CS', 'LastName': 'Kim', 'Affiliation': 'Department of Pediatrics, Dongsan Medical Center, Keimyung University School of Medicine, Daegu, Republic of Korea. Electronic address: cskim@dsmc.or.kr.'}, {'ForeName': 'Byung Wook', 'Initials': 'BW', 'LastName': 'Eun', 'Affiliation': 'Department of Pediatrics, Nowon Eulji Medical Center, Eulji University School of Medicine, Seoul, Republic of Korea. Electronic address: acet0125@hanmail.net.'}, {'ForeName': 'Hwang Min', 'Initials': 'HM', 'LastName': 'Kim', 'Affiliation': 'Department of Pediatrics, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea. Electronic address: khm9120@yonsei.ac.kr.'}, {'ForeName': 'Dong Ho', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Department of Pediatrics, Korea Cancer Center Hospital, Seoul, Republic of Korea. Electronic address: kdh281920@gmail.com.'}, {'ForeName': 'Song Eun', 'Initials': 'SE', 'LastName': 'Song', 'Affiliation': ""Department of Pediatrics, Chonnam National University Children's Hospital, Gwangju, Republic of Korea. Electronic address: essong@jnu.ac.kr.""}, {'ForeName': 'Dae Sun', 'Initials': 'DS', 'LastName': 'Jo', 'Affiliation': ""Department of Pediatrics, Chonbuk National University Children's Hospital, Jeonju, Republic of Korea. Electronic address: drjo@chonbuk.ac.kr.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Pediatrics, Hanil General Hospital, Seoul, Republic of Korea. Electronic address: pedleejin@naver.com.'}, {'ForeName': 'Sang Hyuk', 'Initials': 'SH', 'LastName': 'Ma', 'Affiliation': 'Department of Pediatrics, Changwon Fatima Hospital, Changwon, Republic of Korea. Electronic address: msh6517@hanmail.net.'}, {'ForeName': 'Kwang Nam', 'Initials': 'KN', 'LastName': 'Kim', 'Affiliation': 'Department of Pediatrics, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea. Electronic address: kwangkim52@hanmail.net.'}, {'ForeName': 'Jin Han', 'Initials': 'JH', 'LastName': 'Kang', 'Affiliation': ""Department of Pediatrics, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea; Vaccine Bio Research Institute, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. Electronic address: kjhan@catholic.ac.kr.""}]",Vaccine,['10.1016/j.vaccine.2021.03.005'] 2536,33734750,"Providing witnesses with an option to say ""I'm not sure"" to a showup neither improves classification performance nor the reliability of suspect identifications.","Objective: Past research with one-person showup identification procedures suggests that providing witnesses with an explicit option to opt-out reduces innocent-suspect identifications without reducing culprit identifications (Weber & Perfect, 2012). This finding suggests that improving performance from identification procedures might be as simple as providing witnesses with the option to opt-out from deciding. We examined whether providing witnesses with an option to say ""not sure"" improved performance from showup procedures. Hypotheses: We predicted that participants would opt-out more when given a poor view. We also predicted that classification performance would be better for those who had option to opt-out, and this improvement would be more pronounced for those who had a poor view. Finally, we predicted that the opt-out option would reduce more low-confidence than high-confidence decisions. Method: We randomly assigned Amazon Mechanical Turk Workers (Experiment 1A: N = 2,003, average age = 36.90 [ SD = 11.67], 57.86% female) and university students (Experiment 1B: N = 721, average age = 19.91 ( SD = 3.99), 69.72% female) to a 2 (culprit: present, absent) × 2 (memory strength: strong, weak) × 2 (not sure option: yes, no) between-participants design. We manipulated memory strength by giving witnesses either a clear or degraded view of the encoding video. After watching the encoding video, participants completed a 10-min filler task and were then presented with a showup procedure. Results: Participants who were given a poor view were more likely to opt-out than were participants who were given a clear view. Participants who were given the option to respond not sure reported higher confidence in their decisions. However, the not sure option did not improve classification performance. Conclusion: Contrary to our prediction, we found no evidence that an opt-out option improves performance from a showup procedure, which is consistent with past research examining opt-out options with lineup procedures. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"Contrary to our prediction, we found no evidence that an opt-out option improves performance from a showup procedure, which is consistent with past research examining opt-out options with lineup procedures.","['Results: Participants who were given a poor view', 'Turk Workers (Experiment 1A: N = 2,003, average age = 36.90', ' SD = 11.67], 57.86% female) and university students (Experiment 1B: N = 721, average age = 19.91']",['Amazon Mechanical'],['classification performance'],"[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0337911', 'cui_str': 'Turks'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}]","[{'cui': 'C0008902', 'cui_str': 'Classification'}]",,0.0883237,"Contrary to our prediction, we found no evidence that an opt-out option improves performance from a showup procedure, which is consistent with past research examining opt-out options with lineup procedures.","[{'ForeName': 'Shaela T', 'Initials': 'ST', 'LastName': 'Jalava', 'Affiliation': ""Department of Psychology, Queen's University.""}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Smith', 'Affiliation': 'Department of Psychology, Iowa State University.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Mackovichova', 'Affiliation': 'Department of Psychology, Carleton University.'}]",Law and human behavior,['10.1037/lhb0000434'] 2537,33714847,Nelotanserin as symptomatic treatment for rapid eye movement sleep behavior disorder: a double-blind randomized study using video analysis in patients with dementia with Lewy bodies or Parkinson's disease dementia.,"STUDY OBJECTIVES Rapid eye movement sleep behavior disorder (RBD) is frequent in dementia with Lewy bodies (DLB) and Parkinson's disease dementia (PDD), and poses a risk of injury to patients and their bed partners. We assessed the efficacy of nelotanserin, a selective 5-HT (2A) inverse agonist, for symptomatic treatment of RBD using systematic video analysis. METHODS This was a phase 2 multicenter study in DLB or PDD with video polysomnography (vPSG)-confirmed RBD. After a single-blind placebo run-in period, patients meeting eligibility criteria entered a 4-week double-blind treatment period (1:1 ratio with nelotanserin 80 mg/placebo). Whole-night vPSG was conducted during the run-in and at the end of the treatment period. Videos of all rapid eye movement (REM) sleep periods were analysed for RBD behaviors (movements and vocalizations) using the Innsbruck classification system by two of the central reviewers, and a third reviewer adjudicated ambiguous cases. RESULTS 34 patients (N = 26 DLB, N = 8 PDD; 85.3% men; mean age 71.3 ± 6.36 years) were included in the analyses. Two (5.9%) patients were excluded due to protocol deviation in treatment compliance. Systematic video analysis demonstrated no difference between nelotanserin and placebo in RBD behaviors. Bland-Altman plot showed high interrater reliability. CONCLUSIONS Despite negative results, this is the first randomized, placebo-controlled study on symptomatic RBD treatment using objective outcome measures based on systematic video analysis. This study provides a new method for outcome research in RBD and proves that movement analysis is a feasible and meaningful outcome for studies evaluating changes in RBD severity. CLINICAL TRIAL INFORMATION ClinicalTrials.gov. NCT Number NCT02708186. https://clinicaltrials.gov/ct2/show/NCT02708186.",2021,Systematic video analysis demonstrated no difference between nelotanserin and placebo in RBD behaviors.,"['Rapid eye movement sleep behavior disorder (RBD', 'rapid eye movement sleep behavior disorder', '34 patients (N\xa0=\xa026 DLB, N\xa0=\xa08 PDD; 85.3% men; mean age 71.3\xa0±\xa06.36 years', ""dementia with Lewy bodies (DLB) and Parkinson's disease dementia (PDD"", ""patients with dementia with Lewy bodies or Parkinson's disease dementia""]","['nelotanserin 80 mg/placebo', 'placebo', 'nelotanserin, a selective 5-HT (2A) inverse agonist', 'Nelotanserin', 'video polysomnography (vPSG)-confirmed RBD', 'nelotanserin and placebo']",['RBD behaviors (movements and vocalizations'],"[{'cui': 'C0751772', 'cui_str': 'REM sleep behavior disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0752347', 'cui_str': 'Diffuse Lewy body disease'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C2744299', 'cui_str': 'nelotanserin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0439850', 'cui_str': 'Inverse'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0751772', 'cui_str': 'REM sleep behavior disorder'}]","[{'cui': 'C0751772', 'cui_str': 'REM sleep behavior disorder'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0042932', 'cui_str': 'Singing, Animal'}]",,0.244388,Systematic video analysis demonstrated no difference between nelotanserin and placebo in RBD behaviors.,"[{'ForeName': 'Ambra', 'Initials': 'A', 'LastName': 'Stefani', 'Affiliation': 'Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Santamaria', 'Affiliation': 'Neurology Service, Hospital Clinic de Barcelona, IDIBAPS, CIBERNED, Spain.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Iranzo', 'Affiliation': 'Neurology Service, Hospital Clinic de Barcelona, IDIBAPS, CIBERNED, Spain.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Hackner', 'Affiliation': 'Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Carlos H', 'Initials': 'CH', 'LastName': 'Schenck', 'Affiliation': 'Minnesota Regional Sleep Disorders Center, and Departments of Psychiatry, Hennepin County Medical Center and University of Minnesota Medical School, Minneapolis, USA. Electronic address: schen010@umn.edu.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Högl', 'Affiliation': 'Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria. Electronic address: birgit.ho@i-med.ac.at.'}]",Sleep medicine,['10.1016/j.sleep.2021.02.038'] 2538,33713924,Influence of enhanced nutrition and psychosocial stimulation in early childhood on cognitive functioning and psychological well-being in Guatemalan adults.,"RATIONALE Early-life nutrition interventions in low and middle-income countries have demonstrated long-term benefits on cognitive skills, however, their influence on socioemotional outcomes has not been fully explored. Moreover, the mediating processes through which nutrition intervention effects operate and are maintained over time are understudied. METHODS We followed-up a cohort of Guatemalan adults who participated as children in a community randomized food-supplementation trial. We examined associations of exposure to nutritional supplementation from conception to age 2 years with executive function (measured using three sub-tests of the NIH Toolbox Cognition Battery) and psychological well-being (measured using two sub-scales of the NIH Toolbox Emotion Battery) at ages 40-57 years (n = 1268). We used structural equation modeling to investigate the mediating role of psychosocial stimulation (measured in childhood using parent reports and ratings of home environments), cognitive ability (measured at ages 26-42 years using standardized tests), and executive function on the association of early-life exposure to nutritional supplementation with adult psychological well-being (n = 1640). RESULTS We found positive but inconsistent associations of nutritional supplementation in childhood with executive function and psychological well-being in adulthood. Psychosocial stimulation, cognitive ability, and executive function did not mediate the association of early-life nutritional supplementation with adult psychological well-being. We found strong and positive associations of psychosocial stimulation in childhood with cognitive ability, executive function, and psychological well-being in adulthood. Moreover, we observed no interaction of exposure to nutritional supplementation and psychosocial stimulation in childhood with cognitive and psychological well-being outcomes in adulthood. CONCLUSION Our findings suggest that childhood nutrition interventions have long-lasting effects on cognitive ability and psychological well-being outcomes.",2021,"We found strong and positive associations of psychosocial stimulation in childhood with cognitive ability, executive function, and psychological well-being in adulthood.","['early childhood on cognitive functioning and psychological well-being in Guatemalan adults', 'low and middle-income countries', 'Guatemalan adults who participated as children in a community randomized food-supplementation trial', 'conception to age 2 years with executive function (measured using three sub-tests of the NIH Toolbox Cognition Battery) and psychological well-being (measured using two sub-scales of the NIH Toolbox Emotion Battery) at ages 40-57 years (n\xa0=\xa01268']","['nutritional supplementation with adult psychological well-being (n\xa0=\xa01640', 'enhanced nutrition and psychosocial stimulation', 'nutritional supplementation']","['Psychosocial stimulation, cognitive ability, and executive function']","[{'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",,0.0850646,"We found strong and positive associations of psychosocial stimulation in childhood with cognitive ability, executive function, and psychological well-being in adulthood.","[{'ForeName': 'María J', 'Initials': 'MJ', 'LastName': 'Ramírez-Luzuriaga', 'Affiliation': 'Nutrition and Health Science Program, Laney Graduate School, Emory University, 201 Dowman Drive, Atlanta, GA, 30322, USA.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'DiGirolamo', 'Affiliation': 'Georgia Health Policy Center, Georgia State University, 55 Park Place NE, Eighth Floor, Park Pl NE, Atlanta, GA, 30303, USA.'}, {'ForeName': 'Reynaldo', 'Initials': 'R', 'LastName': 'Martorell', 'Affiliation': 'Nutrition and Health Science Program, Laney Graduate School, Emory University, 201 Dowman Drive, Atlanta, GA, 30322, USA; Hubert Department of Global Health, Rollins School of Public Health, Emory University, 201 Dowman Drive, Atlanta, GA, 30322, USA.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ramírez-Zea', 'Affiliation': 'INCAP Research Center for the Prevention of Chronic Diseases (CIIPEC), Institute of Nutrition of Central America and Panama (INCAP), Calzada Roosevelt 6-25 zona 11, Guatemala City, Guatemala.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Waford', 'Affiliation': 'Nutrition and Health Science Program, Laney Graduate School, Emory University, 201 Dowman Drive, Atlanta, GA, 30322, USA; Hubert Department of Global Health, Rollins School of Public Health, Emory University, 201 Dowman Drive, Atlanta, GA, 30322, USA.'}, {'ForeName': 'Aryeh D', 'Initials': 'AD', 'LastName': 'Stein', 'Affiliation': 'Nutrition and Health Science Program, Laney Graduate School, Emory University, 201 Dowman Drive, Atlanta, GA, 30322, USA; Hubert Department of Global Health, Rollins School of Public Health, Emory University, 201 Dowman Drive, Atlanta, GA, 30322, USA. Electronic address: aryeh.stein@emory.edu.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2021.113810'] 2539,33742692,Nitrate-rich diet alters the composition of the oral microbiota in periodontal recall patients.,"BACKGROUND This follow-up study evaluated microbiome changes in periodontal recall patients after consuming a nitrate-rich diet that led to a marked decrease of gingival inflammation. METHODS Subgingival microbial samples of 37 patients suffering from gingival inflammation with reduced periodontium were taken before professional mechanical plaque removal (baseline) and subsequently after 2 weeks of regularly consuming a lettuce juice beverage (day 14) containing a daily dosage of 200 mg of nitrate (test group, n = 18) or being void of nitrate (placebo group, n = 19). Three hundred base pairs paired-end sequencing of the V3-V4 hypervariable region of the 16S rDNA was performed. RESULTS At baseline, there were no significant differences about the bacterial diversity parameters between the groups (Mann-Whitney U test). After intervention in the test group, Rothia and Neisseria, including species reducing nitrate, increased significantly (negative binomial regression model). Alpha diversity decreased significantly from 115.69 ± 24.30 to 96.42 ± 24.82 aRSVs/sample (P = 0.04, Wilcoxon signed-rank test), accompanied by a significant change in beta diversity (P < 0.001, PERMANOVA). In the control group, however, no genus changed significantly, and alpha-, as well as beta-diversity did not change significantly. CONCLUSIONS The decrease of gingival inflammation in periodontal recall patients induced by a nitrate-rich diet is accompanied by significant compositional changes within the subgingival microbiome.",2021,"Alpha diversity decreased significantly from 115.69 ± 24.30 to 96.42 ± 24.82 aRSVs / sample (p = 0.04, Wilcoxon-Signed-Rank-test), accompanied by a significant change in beta diversity (p < 0.001, PERMANOVA).","['Subgingival microbial samples of 37 patients suffering from gingival inflammation with reduced periodontium were taken before professional mechanical plaque removal (baseline) and subsequently after two weeks of regularly consuming a', 'periodontal recall patients']","['nitrate-rich diet', 'lettuce juice beverage (day 14) containing a daily dosage of 200 mg of nitrate (test group, n = 18) or being void of nitrate (placebo']","['beta-diversity', 'gingival inflammation', 'bacterial diversity parameters', 'Alpha diversity', 'beta diversity']","[{'cui': 'C0595817', 'cui_str': 'Subgingival route'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0031093', 'cui_str': 'Periodontal ligament'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]","[{'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0242765', 'cui_str': 'Lettuce'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}]",300.0,0.0341748,"Alpha diversity decreased significantly from 115.69 ± 24.30 to 96.42 ± 24.82 aRSVs / sample (p = 0.04, Wilcoxon-Signed-Rank-test), accompanied by a significant change in beta diversity (p < 0.001, PERMANOVA).","[{'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Jockel-Schneider', 'Affiliation': 'Division of Periodontology, University Hospital of Julius-Maximilians-University, Würzburg, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Schlagenhauf', 'Affiliation': 'Division of Periodontology, University Hospital of Julius-Maximilians-University, Würzburg, Germany.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Stölzel', 'Affiliation': 'Division of Periodontology, University Hospital of Julius-Maximilians-University, Würzburg, Germany.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Goßner', 'Affiliation': 'Institute of Food Technology, Chair Plant Foodstuff Technology and Analysis, University of Hohenheim, Stuttgart, Germany.'}, {'ForeName': 'Reinhold', 'Initials': 'R', 'LastName': 'Carle', 'Affiliation': 'Institute of Food Technology, Chair Plant Foodstuff Technology and Analysis, University of Hohenheim, Stuttgart, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Ehmke', 'Affiliation': 'Department of Periodontology and Operative Dentistry, University Hospital of Münster, Münster, Germany.'}, {'ForeName': 'Karola', 'Initials': 'K', 'LastName': 'Prior', 'Affiliation': 'Department of Periodontology and Operative Dentistry, University Hospital of Münster, Münster, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hagenfeld', 'Affiliation': 'Department of Periodontology and Operative Dentistry, University Hospital of Münster, Münster, Germany.'}]",Journal of periodontology,['10.1002/JPER.20-0778'] 2540,33740610,Prospective evaluation of third-generation small bowel capsule endoscopy videos by independent readers demonstrates poor reproducibility of cleanliness classifications.,"OBJECTIVE The detection of lesions during small bowel (SB) capsule endoscopy (CE) depends on the cleanliness of the intestine. Quality reporting and comparison of different preparation methods require reliable scores. Three scores known as quantitative index (QI), qualitative evaluation (QE), and overall adequacy assessment (OAA), have been proposed to assess SB cleanliness, and are sometimes used in clinical practice and in clinical trials. However, none of these scores has received any external validation. The aim of our study was to re-assess the reproducibility of these three specific scores. METHODS One-hundred-and-fifty-five complete third-generation SB-CE video recordings were extracted from a multicenter randomized controlled trial (PREPINTEST) which evaluated three modalities of SB preparation for CE. Three experts independently read the 155 SB-CE video recordings twice, in a random order, over 48 -h periods at 6-week intervals, using the QI, QE and OAA scores. Cohen's linearly weighted kappa coefficients were calculated to assess intra-observer and inter-observer agreements. RESULTS Intra-observer reproducibility was fair to moderate, with kappa coefficients between 0.37 and 0.46 for QI, 0.41 and 0.51 for QE, 0.41 and 0.50 for OAA. Inter-observer reproducibility was fair to substantial according to kappa coefficients between experts varying from 0.40 to 0.64, 0.29 to 0.65, and 0.52 to 0.71, for QI, QE and OAA, respectively. CONCLUSIONS QI, QE and OAA scores, currently used for evaluation of the quality of the preparation of SB-CE, are not sufficiently reproducible. Other scores or methods are therefore needed for SB-CE cleanliness assessment.",2021,"Inter-observer reproducibility was fair to substantial according to kappa coefficients between experts varying from 0.40 to 0.64, 0.29 to 0.65, and 0.52 to 0.71, for QI, QE and OAA, respectively. ",['One-hundred-and-fifty-five complete third-generation SB-CE video recordings'],['third-generation small bowel capsule endoscopy videos'],"['QE and OAA scores', 'quantitative index (QI), qualitative evaluation (QE), and overall adequacy assessment (OAA']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C4285996', 'cui_str': 'Small bowel capsule endoscopy'}, {'cui': 'C0042650', 'cui_str': 'Audiovisual Recording'}]","[{'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C4285996', 'cui_str': 'Small bowel capsule endoscopy'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0034375', 'cui_str': 'Qualitative Evaluation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0530148,"Inter-observer reproducibility was fair to substantial according to kappa coefficients between experts varying from 0.40 to 0.64, 0.29 to 0.65, and 0.52 to 0.71, for QI, QE and OAA, respectively. ","[{'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Dray', 'Affiliation': 'Sorbonne University, Center for Digestive Endoscopy, Hôpital Saint-Antoine, APHP, 184 rue du Faubourg Saint-Antoine, 75012 Paris, France. Electronic address: xavier.dray@aphp.fr.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Houist', 'Affiliation': 'Department of Hepato-Gastroenterology, Centre Hospitalier du Sud Francilien, 40 Avenue Serge Dassault, 91100 Corbeil-Essonnes, France.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Le Mouel', 'Affiliation': 'Department of Hepato-Gastroenterology, Amiens University Hospital, Amiens, France.'}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Saurin', 'Affiliation': 'Department of Hepato-gastroenterology, E. Herriot Hospital, Hospices Civils de Lyon, France.'}, {'ForeName': 'Geoffroy', 'Initials': 'G', 'LastName': 'Vanbiervliet', 'Affiliation': ""Department of Hepato-Gastroenterology, L'Archet 2 Hospital, Nice University Hospital, Nice, F-06202 Cedex 3, France.""}, {'ForeName': 'Chloé', 'Initials': 'C', 'LastName': 'Leandri', 'Affiliation': 'Department of Hepato-Gastroenterology, Cochin Hospital, AP-HP, 75014, Paris, France.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Rahmi', 'Affiliation': 'Department of Hepato-Gastroenterology, Georges Pompidou European Hospital, AP-HP, Paris Descartes University, France.'}, {'ForeName': 'Clotilde', 'Initials': 'C', 'LastName': 'Duburque', 'Affiliation': 'Delegations for Clinical Research and Innovation - Department of Gastroenterology Lille Catholic Hospitals - Lille Catholic University, Lille, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Kirchgesner', 'Affiliation': 'Sorbonne University and Department of Gastroenterology, Hôpital Saint-Antoine, Paris, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Leenhardt', 'Affiliation': 'Sorbonne University, Center for Digestive Endoscopy, Hôpital Saint-Antoine, APHP, 184 rue du Faubourg Saint-Antoine, 75012 Paris, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Cholet', 'Affiliation': 'Department of Hepato-Gastroenterology, Brest University Hospital, Bd Tanguy Prigent, 29200 BREST, France.'}]",Clinics and research in hepatology and gastroenterology,['10.1016/j.clinre.2020.101612'] 2541,33740589,The roles of caffeine and corticosteroids in modulating cortical excitability after paired associative stimulation (PAS) and transcranial alternating current stimulation (tACS) in caffeine-naïve and caffeine-adapted subjects.,"The modulatory effects of non-invasive brain stimulation (NIBS) are highly variable between subjects. This variability may be due to uncontrolled caffeine consumption and circadian rhythms. Therefore, here we studied if caffeine consumption, systemically available caffeine measured in saliva, and daytime have effects on the excitability and plasticity of the motor cortex. Since both, time of the day and caffeine may mediate their effects via cortisol, we also quantified corticosteroids in saliva. Experiment 1 was performed in caffeine-naïve participants (n = 30) and compared the effects of PAS or tACS with different stimulation intensities on the motor cortex with or without caffeine 200 mg administered in a double-blind fashion. Experiment 2 was performed in regular caffeine consumers (n = 30) and compared the influence of time of day on the effects of tACS (true or sham) on the motor cortex also with or without caffeine administered in a double-blind fashion. Caffeine increased the saliva corticosteroid concentrations in both experimental groups, and corticosteroid concentrations were higher in the morning in caffeine consumers. Gender also affected corticosteroid concentrations. There was a positive correlation between caffeine concentrations and baseline cortical excitability in caffeine-adapted participants, and a negative correlation between poststimulation caffeine concentrations and motor evoked potential (MEP) amplitudes after sham stimulation in caffeine-naïve subjects. No correlations were found between poststimulation caffeine or corticosteroid concentrations, and plasticity aftereffects. PAS and tACS did not elicit changes in the corticosteroid concentrations. We conclude that moderate caffeine consumption alters cortical excitability but not plasticity aftereffects. This study was registered in the ClinicalTrials.gov with these registration IDs: 1) NCT03720665 https://clinicaltrials.gov/ct2/results?cond=NCT03720665&term=&cntry=&state=&city=&dist= 2) NCT04011670 https://clinicaltrials.gov/ct2/results?cond=&term=NCT04011670&cntry=&state=&city=&dist=.",2021,"Caffeine increased the saliva corticosteroid concentrations in both experimental groups, and corticosteroid concentrations were higher in the morning in caffeine consumers.",['caffeine-naïve and caffeine-adapted subjects'],"['PAS or tACS with different stimulation intensities on the motor cortex with or without caffeine 200\xa0mg administered in a double-blind fashion', 'caffeine and corticosteroids', 'NCT04011670&cntry=&state=&city=&dist', 'non-invasive brain stimulation (NIBS', 'Caffeine', 'tACS (true or sham) on the motor cortex also with or without caffeine', 'paired associative stimulation (PAS) and transcranial alternating current stimulation (tACS']","['corticosteroid concentrations', 'saliva corticosteroid concentrations', 'poststimulation caffeine or corticosteroid concentrations, and plasticity aftereffects', 'caffeine concentrations and baseline cortical excitability', 'poststimulation caffeine concentrations and motor evoked potential (MEP) amplitudes']","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}]","[{'cui': 'C0030125', 'cui_str': 'aminosalicylic acid'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0993287', 'cui_str': 'Caffeine 200 MG'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}, {'cui': 'C0205238', 'cui_str': 'True'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0678558', 'cui_str': 'Plasticity'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}]",,0.231398,"Caffeine increased the saliva corticosteroid concentrations in both experimental groups, and corticosteroid concentrations were higher in the morning in caffeine consumers.","[{'ForeName': 'Mohd Faizal Mohd', 'Initials': 'MFM', 'LastName': 'Zulkifly', 'Affiliation': 'Department of Clinical Neurophysiology, University Medical Center, Georg-August University, Göttingen, Germany; Brain and Behaviour Cluster, Department of Neurosciences, School of Medical Science, Universiti Sains Malaysia Health Campus, Kubang Kerian, Kota Bharu, Kelantan, Malaysia. Electronic address: faizal.zulkifly@usm.my.'}, {'ForeName': 'Ornela', 'Initials': 'O', 'LastName': 'Merkohitaj', 'Affiliation': 'Department of Clinical Neurophysiology, University Medical Center, Georg-August University, Göttingen, Germany.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Paulus', 'Affiliation': 'Department of Clinical Neurophysiology, University Medical Center, Georg-August University, Göttingen, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Brockmöller', 'Affiliation': 'Department of Clinical Pharmacology, University Medical Center, Georg-August University, Göttingen, Germany.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2021.105201'] 2542,33740496,Effects of an exercise program on health of people with epilepsy: A randomized clinical trial.,"To evaluate the effects of an exercise program on the health of people with epilepsy (PWE) and seizure frequency. A randomized clinical trial was carried out in Pelotas/Brazil. Recruitment was conducted through social media, in local press, and Public Health System facilities. The intervention program was performed at the gym of the Physical Education School/Federal University of Pelotas. A total of 21 people, aged 18-60 years, diagnosed with epilepsy and who were not engaged in systematic physical exercise in the last three months were divided into two groups: (1) exercise (EG) - 12 weeks of a structured physical exercise program; (2) control (CG) - no exercise and maintenance of usual activities. The allocation rate 1:1 was used. The exercise program consisted of two 60-min weekly sessions including warm-up (5-min), aerobic training (15-25 min at 14-17 on Borg scale), resistance training (2-3 sets, 10-15 repetitions), and stretching. Sociodemographic, clinical and health variables (frequency and number of seizures, quality of life, depression, anxiety, and side effects), anthropometrics (weight, height, hip and waist circumferences), cardiorespiratory fitness (VO 2max ), and strength (dynamometry) were measured at baseline and after the 12-week intervention. Generalized Estimating Equations (GEE) and Bonferroni posthoc tests were used for the comparison between moments and groups. Eleven participants were randomized to EG and 10 to CG. One EG participant did not complete the study. There was a reduction in frequency of epileptic seizures during the 3-month intervention period in EG (p = 0.010) with no improvement in CG. Improvement in quality of life (p = 0.004), stress levels (p = 0.017) and physical fitness (p = 0.017) were also observed in the EG compared to CG. A structured physical exercise program improved overall health of PWE and decreased seizure frequency.",2021,"Improvement in quality of life (p = 0.004), stress levels (p = 0.017) and physical fitness (p = 0.017) were also observed in the EG compared to CG.","['Eleven participants', 'A total of 21 people, aged 18-60\u202fyears, diagnosed with epilepsy and who were not engaged in systematic physical exercise in the last three months', 'people with epilepsy (PWE) and seizure frequency']","['structured physical exercise program', 'exercise (EG) - 12\u202fweeks of a structured physical exercise program; (2) control (CG) - no exercise and maintenance of usual activities', 'aerobic training', 'resistance training', 'exercise program']","['quality of life', 'frequency of epileptic seizures', 'Sociodemographic, clinical and health variables (frequency and number of seizures, quality of life, depression, anxiety, and side effects), anthropometrics (weight, height, hip and waist circumferences), cardiorespiratory fitness (VO 2max ), and strength (dynamometry', 'physical fitness', 'health of people with epilepsy', 'overall health of PWE and decreased seizure frequency', 'stress levels']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]",11.0,0.00522991,"Improvement in quality of life (p = 0.004), stress levels (p = 0.017) and physical fitness (p = 0.017) were also observed in the EG compared to CG.","[{'ForeName': 'César Augusto', 'Initials': 'CA', 'LastName': 'Häfele', 'Affiliation': 'Federal University of Pelotas, School of Physical Education, Pelotas, Brazil. Electronic address: hafele.c@hotmail.com.'}, {'ForeName': 'Airton José', 'Initials': 'AJ', 'LastName': 'Rombaldi', 'Affiliation': 'Federal University of Pelotas, School of Physical Education, Pelotas, Brazil.'}, {'ForeName': 'Natan', 'Initials': 'N', 'LastName': 'Feter', 'Affiliation': 'Federal University of Pelotas, School of Physical Education, Pelotas, Brazil; The University of Queensland, School of Human Movement and Nutrition Sciences, St Lucia Campus, Brisbane, Australia.'}, {'ForeName': 'Vítor', 'Initials': 'V', 'LastName': 'Häfele', 'Affiliation': 'Federal University of Pelotas, School of Physical Education, Pelotas, Brazil.'}, {'ForeName': 'Bianca Lamas', 'Initials': 'BL', 'LastName': 'Gervini', 'Affiliation': 'Brazilian Hospital Services Company (EBSERH), Pelotas, Brazil.'}, {'ForeName': 'Marlos Rodrigues', 'Initials': 'MR', 'LastName': 'Domingues', 'Affiliation': 'Federal University of Pelotas, School of Physical Education, Pelotas, Brazil.'}, {'ForeName': 'Marcelo Cozzensa', 'Initials': 'MC', 'LastName': 'da Silva', 'Affiliation': 'Federal University of Pelotas, School of Physical Education, Pelotas, Brazil.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2021.107904'] 2543,33745264,The comparative effects of intravenous iron on oxidative stress and inflammation in patients with chronic kidney disease and iron deficiency: a randomized controlled pilot study.,"BACKGROUND Concerns exist regarding the pro-oxidant and inflammatory potential of intravenous (IV) iron due to labile plasma iron (LPI) generation. This IRON-CKD trial compared the effects of different IV irons on oxidative stress and inflammation. METHODS In this randomized open-label explorative single-center study in the United Kingdom, non-dialysis-dependent chronic kidney disease (CKD) patients with iron deficiency were randomized (1:1:1:1) to receive a single infusion of 200 mg iron dextran, or 200 mg iron sucrose (IS), or 200 mg or 1,000 mg ferric derisomaltose (FDI) and were followed up for 3 months. The primary outcomes measured were induction of oxidative stress and inflammation. Secondarily, efficacy, vascular function, quality of life, and safety were monitored. RESULTS Forty patients were enrolled. No significant rise in oxidative stress existed, regardless of preparation or dose. There was a significant rise in LPI with 1,000 mg FDI at 2 hours that normalized within a week, not impacting oxidative stress or inflammation. A delayed rise in C-reactive protein was noted with IS. High-dose FDI produced a sustained serum ferritin increase (mean ± standard error of the mean of predose: 69.1 ± 18.4 μg/L, 3 months: 271.0 ± 83.3 μg/L; p = 0.007). Hemoglobin remained stable throughout. No adverse drug reactions were recorded during the study. CONCLUSION A single dose of IV iron in CKD patients does not trigger oxidative stress or inflammation biomarkers. Third-generation IV irons have a reassuring safety profile, and high-dose FDI produced a sustained serum ferritin rise and more efficient iron repletion, with no significant pro-oxidant or inflammatory signals when compared to a lower dose and other IV irons.",2021,"No adverse drug reactions were recorded during the study. ","['Forty patients were enrolled', 'CKD patients', 'United Kingdom, non-dialysis-dependent chronic kidney disease (CKD) patients with iron deficiency', 'patients with chronic kidney disease and iron deficiency']","['intravenous iron', 'single infusion of 200 mg iron dextran, or 200 mg iron sucrose (IS), or 200 mg or 1,000 mg ferric derisomaltose (FDI']","['Hemoglobin', 'adverse drug reactions', 'oxidative stress and inflammation', 'trigger oxidative stress or inflammation biomarkers', 'LPI', 'induction of oxidative stress and inflammation', 'sustained serum ferritin increase', 'Secondarily, efficacy, vascular function, quality of life, and safety', 'oxidative stress', 'oxidative stress or inflammation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0022092', 'cui_str': 'Iron-Dextran Complex'}, {'cui': 'C0060241', 'cui_str': 'iron sucrose'}, {'cui': 'C3848561', 'cui_str': 'ferric cation'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0858126', 'cui_str': 'Plasma iron'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",40.0,0.0610952,"No adverse drug reactions were recorded during the study. ","[{'ForeName': 'Xenophon', 'Initials': 'X', 'LastName': 'Kassianides', 'Affiliation': 'Academic Renal Research Department, Hull University Teaching Hospitals NHS Trust and Hull York Medical School, Hull Royal Infirmary, Hull, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Gordon', 'Affiliation': 'Centre for Atherothrombosis and Metabolic Disease, Hull York Medical School, University of Hull, Hull, UK.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Sturmey', 'Affiliation': 'Centre for Atherothrombosis and Metabolic Disease, Hull York Medical School, University of Hull, Hull, UK.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Bhandari', 'Affiliation': 'Academic Renal Research Department, Hull University Teaching Hospitals NHS Trust and Hull York Medical School, Hull Royal Infirmary, Hull, UK.'}]",Kidney research and clinical practice,['10.23876/j.krcp.20.120'] 2544,33744812,A randomized phase IIa study of quantified bone scan response in patients with metastatic castration-resistant prostate cancer (mCRPC) treated with radium-223 dichloride alone or in combination with abiraterone acetate/prednisone or enzalutamide.,"BACKGROUND In metastatic castration-resistant prostate cancer (mCRPC), assessing treatment response and bone lesions with technetium-99m is limited by image resolution and subjectivity. We evaluated bone scan lesion area (BSLA), a quantitative imaging assessment of response in patients with mCRPC receiving radium-223 alone or in combination with androgen receptor pathway inhibitors (abiraterone/prednisone or enzalutamide). PATIENTS AND METHODS This randomized, non-comparative phase IIa three-arm trial (NCT02034552) evaluated technetium-99m-based BSLA response rate (RR), safety, radiologic progression-free survival (rPFS), and time to first symptomatic skeletal event (SSE) in men with mCRPC and bone metastases receiving radium-223 with/without abiraterone/prednisone or enzalutamide. The primary endpoint was week 24 BSLA RR. RESULTS Overall, 63 patients received treatment (abiraterone/prednisone combination, n = 22; enzalutamide combination, n = 22; radium-223 monotherapy, n = 19). Median treatment duration (first to last dose of any study treatment) was 12 months (abiraterone/prednisone combination), 10 months (enzalutamide combination), and 3 months (radium-223 monotherapy). Week 24 BSLA RR was 58% [80% confidence interval (CI) 41% to 74%; one-sided P < 0.0001; 11/19 patients] with abiraterone/prednisone combination, 50% (32% to 68%; one-sided P < 0.0001; 8/16 patients) with enzalutamide combination, and 22% (10% to 40%; one-sided P = 0.0109; 4/18 patients) with radium-223 monotherapy. Median rPFS was not evaluable for combination arms and 4 months (80% CI 4 to 12) for monotherapy. SSEs were reported in 32% of patients; median time to first SSE was not estimable. Fatigue and back pain were the most commonly reported treatment-emergent adverse events (TEAEs); more patients receiving combination therapy than monotherapy had TEAEs. Fractures were reported in 18% receiving abiraterone/prednisone, 32% receiving enzalutamide, and 11% receiving radium-223 monotherapy. Fracture rates were lower in patients taking bone health agents versus not taking bone health agents at baseline. CONCLUSIONS Technetium-99m imaging BSLA may offer objective, quantifiable assessment of isotope uptake changes, and potentially treatment response, in patients with mCRPC and bone metastases treated with radium-223 alone or in combination with abiraterone/prednisone or enzalutamide. In this largely treatment-naive population, BSLA RR was numerically lower with radium-223 monotherapy versus combination therapy, indicating a limited role as first-line treatment. Use of radium-223 should follow evidence-based treatment guidelines and the licensed indication.",2021,Median rPFS was not evaluable for combination arms and 4 months (80% CI 4 to 12) for monotherapy.,"['patients with mCRPC and bone metastases treated with radium-223 alone or in combination with', '63 patients received', 'patients with mCRPC receiving radium-223 alone or in combination with', 'metastatic castration-resistant prostate cancer (mCRPC', 'patients with metastatic castration-resistant prostate cancer (mCRPC) treated with', 'men with mCRPC and bone metastases receiving radium-223 with/without']","['radium-223 dichloride alone or in combination with abiraterone acetate/prednisone or enzalutamide', 'androgen receptor pathway inhibitors (abiraterone/prednisone or enzalutamide', 'enzalutamide', 'treatment (abiraterone/prednisone combination, n\xa0= 22; enzalutamide combination, n\xa0= 22; radium-223 monotherapy', 'radium-223 monotherapy', 'abiraterone/prednisone', 'abiraterone/prednisone or enzalutamide']","['SSEs', 'technetium-99m-based BSLA response rate (RR), safety, radiologic progression-free survival (rPFS), and time to first symptomatic skeletal event (SSE', 'Median treatment duration', 'Median rPFS', 'Fatigue and back pain', 'median time to first SSE', '24 BSLA RR', 'Fractures', 'Fracture rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0153690', 'cui_str': 'Secondary malignant neoplasm of bone'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0303282', 'cui_str': 'Radium-223'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C3541342', 'cui_str': 'RADIUM CHLORIDE RA-223'}, {'cui': 'C2607886', 'cui_str': 'Abiraterone acetate'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0034786', 'cui_str': 'Androgen receptor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0303282', 'cui_str': 'Radium-223'}]","[{'cui': 'C0303611', 'cui_str': 'Technetium 99m'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0203668', 'cui_str': 'Radioisotope scan of bone'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]",,0.0865232,Median rPFS was not evaluable for combination arms and 4 months (80% CI 4 to 12) for monotherapy.,"[{'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Petrylak', 'Affiliation': 'Department of Urology, Yale School of Medicine, New Haven, USA. Electronic address: daniel.petrylak@yale.edu.'}, {'ForeName': 'U N', 'Initials': 'UN', 'LastName': 'Vaishampayan', 'Affiliation': 'Division of Solid Tumor Oncology, Karmanos Cancer Institute, Detroit, USA.'}, {'ForeName': 'K R', 'Initials': 'KR', 'LastName': 'Patel', 'Affiliation': 'Arizona Institute of Urology, Tucson, USA.'}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Higano', 'Affiliation': 'University of Washington, Seattle, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Albany', 'Affiliation': 'Indiana University Health Melvin and Bren Simon Cancer Center, Indianapolis, USA.'}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Dawson', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Washington, USA.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Mehlhaff', 'Affiliation': 'Oregon Urology Institute, Springfield, USA.'}, {'ForeName': 'D I', 'Initials': 'DI', 'LastName': 'Quinn', 'Affiliation': 'Department of Medicine, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, USA.'}, {'ForeName': 'L T', 'Initials': 'LT', 'LastName': 'Nordquist', 'Affiliation': 'Department of Medical Oncology, Genitourinary Research Network, Omaha, USA.'}, {'ForeName': 'V J', 'Initials': 'VJ', 'LastName': 'Wagner', 'Affiliation': 'Bayer Consumer Care AG, Basel, Switzerland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Siegel', 'Affiliation': 'Oncology Clinical Statistics, Bayer HealthCare Pharmaceuticals Inc., Whippany, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Trandafir', 'Affiliation': 'Bayer Consumer Care AG, Basel, Switzerland.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Sartor', 'Affiliation': 'Tulane Cancer Center, Tulane University School of Medicine, New Orleans, USA.'}]",ESMO open,['10.1016/j.esmoop.2021.100082'] 2545,33744810,[Impact of training on Motivational Interviewing (MI) for Family Physicians: Design and assessment of a Training Program (MOTIVA)].,"AIM To develop a training program in Motivational Interviewing for Family Physicians and assess the impact. STUDY DESIGN Multicenter, double blind and randomized clinical essay, with 2arms, Experimental (EG) and Control (CG) of Family Physicians with a follow up of 12 months. LOCATION 32 Primary Healthcare Centers. SAMPLE DESCRIPTION 54 physicians (CG=28, EG=26). INTERVENTIONS Training Program MOTIVA in ME with an initial presential course (16h), followed by online activities during 12months, and presential meetings (Problem BasedInterviewing with expert feedback). MAIN MEASUREMENTS Communicative skills in MI were assessed based on video-recordings (VR) with the EVEM 2.0 scale by peer reviewers. 236 VR with standardized patients and 96 VR with real patients. RESULTS Average results in EVEM scale (up to 56 points) at the beginning of the study were EG=21.27 (CI 95% 15.8-26.7) and CG=20.23 (CI95% 16.4-23.9) with no differences between both groups (P=.79). After the training, EG punctuation increased by 13.89 points (P<.001), average 35.16 (CI 95% 29.8-40.6). Real patients' VR in EG over a 12 month period keep their MI skills with an average of 36.9 points (CI 95% 30.3-43.6) versus CG 15.9 points (CI 95% 9.8-22.0). Once ended the MOTIVA Training Program, the EG maintains the acquired skills: final average EG=37.6 (CI 95% 33.2-41.1) versus CG=24.3 (CI95% 19.0-29.2) (P<.001). CONCLUSIONS The MOTIVA Training Program improves Motivational Interviewing skills, significatively improving after a presential course and sequential keep-alive activities. The effectiveness of the Program has been proven in the Third and Fourth steps of Miller's Pyramid.",2021,"After the training, EG punctuation increased by 13.89 points (P<.001), average 35.16 (CI 95% 29.8-40.6).","['Family Physicians', '236 VR with standardized patients and 96 VR with real patients', '32 Primary Healthcare Centers', 'Family Physicians with a follow up of 12 months']","['Training Program MOTIVA in ME with an initial presential course (16h), followed by online activities during 12months, and presential meetings (Problem BasedInterviewing with expert feedback', 'training on Motivational Interviewing (MI']","['Communicative skills in MI', 'EVEM scale', 'Motivational Interviewing skills', 'MI skills', 'EG punctuation']","[{'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}, {'cui': 'C0042650', 'cui_str': 'Audiovisual Recording'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]",236.0,0.0419744,"After the training, EG punctuation increased by 13.89 points (P<.001), average 35.16 (CI 95% 29.8-40.6).","[{'ForeName': 'Nieves', 'Initials': 'N', 'LastName': 'Barragán-Brun', 'Affiliation': 'EAP Vallcarca, EBA Vallcarca, Barcelona, España; Miembro del Grupo Programa Comunicación y Salud de semFYC. Electronic address: nbarragan@ebavallcarca.cat.'}, {'ForeName': 'Remedios', 'Initials': 'R', 'LastName': 'Martín-Álvarez', 'Affiliation': 'EAP Vallcarca, EBA Vallcarca, Barcelona, España; Miembro del Grupo Programa Comunicación y Salud de semFYC.'}, {'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Bosch-Fontcuberta', 'Affiliation': 'EAP Encants, Institut Català de la Salut, Barcelona, España; Miembro del Grupo Programa Comunicación y Salud de semFYC.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Campíñez-Navarro', 'Affiliation': 'EAP Vallcarca, EBA Vallcarca, Barcelona, España; Miembro del Grupo Programa Comunicación y Salud de semFYC.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Bóveda-Fontan', 'Affiliation': 'CS Colmeiro, SERGAS, Vigo, Pontevedra, España; Miembro del Grupo Programa Comunicación y Salud de semFYC.'}, {'ForeName': 'Luis Ángel', 'Initials': 'LÁ', 'LastName': 'Pérula-de-Torres', 'Affiliation': 'Instituto Maimónides de Investigación Biomédica-IMIBIC, Hospital Reina Sofía, Córdoba, España; Miembro del Grupo Programa Comunicación y Salud de semFYC.'}]",Atencion primaria,['10.1016/j.aprim.2020.09.010'] 2546,33744781,Health-related quality of life in the randomized phase III trial of brigatinib vs crizotinib in advanced ALK inhibitor-naive ALK + non-small cell lung cancer (ALTA-1L).,"OBJECTIVE In ALTA-1 L, first-line brigatinib versus crizotinib significantly prolonged progression-free survival in advanced ALK-positive (ALK+) non-small cell lung cancer (NSCLC). We report health-related quality of life (HRQOL) outcomes from ALTA-1 L. MATERIALS AND METHODS HRQOL was assessed using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and lung cancer-specific module (QLQ-LC13). HRQOL time to worsening, change from baseline, and duration of improvement were analyzed. RESULTS EORTC QLQ-C30 and QLQ-LC13 compliance was >90 % for both groups (n = 131 each). Brigatinib versus crizotinib significantly delayed time to worsening in the EORTC QLQ-C30 global health status (GHS)/QOL (median: 26.74 vs 8.31 months; hazard ratio [HR]: 0.70; 95 % CI: 0.49, 1.00; log-rank P = 0.0485); emotional functioning, social functioning, fatigue, nausea and vomiting, appetite loss, and constipation scales (log-rank P < 0.05); delays in time to worsening for the physical, role, and cognitive functioning scales were not statistically significant. Mean change from baseline showed greater improvement in GHS/QOL and most EORTC QLQ-C30 functional and symptom scales with brigatinib versus crizotinib. Among patients with GHS/QOL improvement, brigatinib had longer duration of improvement versus crizotinib (median: not reached vs 11.99 months); similar results were seen in the physical, role, emotional, and social functioning; fatigue; nausea and vomiting; and appetite loss scales. Median time to worsening in dyspnea (QLQ-LC13) was 23.98 versus 8.25 months (brigatinib vs crizotinib; HR: 0.64; 95 % CI: 0.39, 1.05). CONCLUSION Brigatinib significantly delayed time to worsening and prolonged duration of improvement in GHS/QOL versus crizotinib, supported by improvement in functional and symptom scores. These preliminary analyses suggest brigatinib is the first ALK inhibitor with better HRQOL versus another ALK inhibitor in ALK inhibitor-naive advanced ALK + NSCLC.",2021,Mean change from baseline showed greater improvement in GHS/QOL and most EORTC QLQ-C30 functional and symptom scales with brigatinib versus crizotinib.,[],['brigatinib vs crizotinib'],"['delayed time to worsening and prolonged duration of improvement in GHS/QOL', 'physical, role, emotional, and social functioning; fatigue; nausea and vomiting; and appetite loss scales', 'EORTC QLQ-C30 and QLQ-LC13 compliance', 'emotional functioning, social functioning, fatigue, nausea and vomiting, appetite loss, and constipation scales', 'HRQOL time to worsening, change from baseline, and duration of improvement', 'functional and symptom scores', 'Health-related quality of life', 'Median time to worsening in dyspnea (QLQ-LC13', 'Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and lung cancer-specific module (QLQ-LC13', 'cognitive functioning scales', 'GHS/QOL and most EORTC QLQ-C30 functional and symptom scales']",[],"[{'cui': 'C4287815', 'cui_str': 'brigatinib'}, {'cui': 'C2974289', 'cui_str': 'crizotinib'}]","[{'cui': 'C0522486', 'cui_str': 'Delay time'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]",,0.177708,Mean change from baseline showed greater improvement in GHS/QOL and most EORTC QLQ-C30 functional and symptom scales with brigatinib versus crizotinib.,"[{'ForeName': 'Maria Rosario', 'Initials': 'MR', 'LastName': 'Garcia Campelo', 'Affiliation': 'Medical Oncology Service, University Hospital A Coruña (XXIAC-SERGAS), Xubias de Arriba, 84, 15006, A Coruña, Spain. Electronic address: MA.Rosario.Garcia.Campelo@sergas.es.'}, {'ForeName': 'Huamao M', 'Initials': 'HM', 'LastName': 'Lin', 'Affiliation': 'Millennium Pharmaceuticals, Inc, 35 Landsdowne Street, Cambridge, MA, 02139, USA(3). Electronic address: mark.lin@takeda.com.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Millennium Pharmaceuticals, Inc, 35 Landsdowne Street, Cambridge, MA, 02139, USA(3). Electronic address: Yanyan.zhu@takeda.com.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Pérol', 'Affiliation': 'Department of Medical Oncology, Centre Léon Bérard, 28 Prom. Léa et Napoléon Bullukian, 69008, Lyon, France. Electronic address: maurice.perol@lyon.unicancer.fr.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Jahanzeb', 'Affiliation': 'Florida Precision Oncology, a division of 21st Century Oncology, 3651 FAU Boulevard, Suite 100, Boca Raton, FL, 33431, USA. Electronic address: mj@fponcology.com.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Popat', 'Affiliation': 'The Royal Marsden Hospital, 203 Fulham Road, Chelsea, London, SW3 6JJ, United Kingdom; The Institute of Cancer Research, 123 Old Brompton Road, London, SW7 3RP, United Kingdom. Electronic address: sanjay.popat@rmh.nhs.uk.'}, {'ForeName': 'Pingkuan', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Millennium Pharmaceuticals, Inc, 300 Massachusetts Avenue, Cambridge, MA, 02139, USA(3). Electronic address: Pingkuan.Zhang@takeda.com.'}, {'ForeName': 'D Ross', 'Initials': 'DR', 'LastName': 'Camidge', 'Affiliation': 'University of Colorado Cancer Center, 1665 Aurora Court, Aurora, CO, 80045, USA. Electronic address: Ross.Camidge@CUAnschutz.edu.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2021.03.005'] 2547,33744191,"Group-based exercise, individually supervised exercise and home-based exercise have similar clinical effects and cost-effectiveness in people with subacromial pain: a randomised trial.","QUESTION What are the relative effects of group-based exercise, individual exercise and home-based exercise on clinical outcomes and costs in patients with subacromial pain? DESIGN Multicentre, three-arm, randomised controlled trial with concealed allocation and intention-to-treat analysis. PARTICIPANTS A total of 208 patients referred to municipal rehabilitation for management of subacromial pain in six municipalities in the Central Denmark Region. INTERVENTIONS Patients were randomly allocated to group-based exercise rehabilitation (GE), individual exercise rehabilitation (IE) or home exercise rehabilitation (HE) for a period of 8 weeks. OUTCOME MEASURES The primary outcome measure was the shortened version of the Disabilities of the Arm, Shoulder and Hand questionnaire (Quick-DASH). The secondary outcome measures included the EQ-5D-5L index, pain intensity, fear avoidance, psychological wellbeing, and the participant's perception of improvement and satisfaction. Healthcare and productivity costs were extracted from national health and social registers. RESULTS There was no important between-group difference in Quick-DASH scores at 6 months: adjusted mean differences GE minus IE -2 (95% CI -9 to 5), GE minus HE -2 (95% CI -9 to 5) and HE minus IE 1 (95% CI -6 to 7). The estimates of the between-group differences were able to exclude any clinically important differences in the three regimens' effects on health benefits according to the EQ-5D-5L index and other secondary outcomes. The total average costs were highest for the IE group and lowest for the HE, but not statistically different across groups. CONCLUSION In people with subacromial pain, group-based exercise, individually supervised exercise and home-based supervised exercise regimens have similar benefits. The home exercise intervention was associated with lowest costs. TRIAL REGISTRATION ClinicalTrials.gov: NCT03055117.",2021,There was no important between-group difference in Quick-DASH scores at 6 months: adjusted mean differences GE minus IE -2,"['A total of 208 patients referred to municipal rehabilitation for management of subacromial pain in six municipalities in the Central Denmark Region', 'patients with subacromial pain', 'people with subacromial pain']","['supervised exercise and home-based supervised exercise regimens', 'group-based exercise, individual exercise and home-based exercise', 'home exercise intervention', 'group-based exercise rehabilitation (GE), individual exercise rehabilitation (IE) or home exercise rehabilitation (HE', 'Group-based exercise, individually supervised exercise and home-based exercise']","['Healthcare and productivity costs', 'total average costs', 'Quick-DASH scores', ""EQ-5D-5L index, pain intensity, fear avoidance, psychological wellbeing, and the participant's perception of improvement and satisfaction"", 'shortened version of the Disabilities of the Arm, Shoulder and Hand questionnaire (Quick-DASH']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0203986', 'cui_str': 'Individual exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",208.0,0.0715308,There was no important between-group difference in Quick-DASH scores at 6 months: adjusted mean differences GE minus IE -2,"[{'ForeName': 'David Høyrup', 'Initials': 'DH', 'LastName': 'Christiansen', 'Affiliation': 'Department of Occupational Medicine, University Research Clinic, Danish Ramazzini Centre Regional Hospital Gødstrup, Herning, Denmark; Department of Clinical Medicine, Health, Aarhus University, Aarhus, Denmark. Electronic address: davchr@rm.dk.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Hjort', 'Affiliation': 'Department of Clinical Medicine, Health, Aarhus University, Aarhus, Denmark.'}]",Journal of physiotherapy,['10.1016/j.jphys.2021.02.015'] 2548,33743788,Action observation treatment-based exoskeleton (AOT-EXO) for upper extremity after stroke: study protocol for a randomized controlled trial.,"BACKGROUND Stroke produces multiple symptoms, including sensory, motor, cognitive and psychological dysfunctions, among which motor deficit is the most common and is widely recognized as a major contributor to long-term functional disability. Robot-assisted training is effective in promoting upper extremity muscle strength and motor impairment recovery after stroke. Additionally, action observation treatment can enhance the effects of physical and occupational therapy by increasing neural activation. The AOT-EXO trial aims to investigate whether action observation treatment coupled with robot-assisted training could enhance motor circuit activation and improve upper extremity motor outcomes. METHODS The AOT-EXO trial is a multicentre, prospective, three-group randomized controlled trial (RCT). We will screen and enrol 132 eligible patients in the trial implemented in the Department of Rehabilitation Medicine of Tongji Hospital, Optical Valley Branch of Tongji Hospital and Hubei Province Hospital of Integrated Chinese & Western Medicine in Wuhan, China. Prior to study participation, written informed consent will be obtained from eligible patients in accordance with the Declaration of Helsinki. The enrolled stroke patients will be randomized to three groups: the CT group (conventional therapy); EXO group (exoskeleton therapy) and AOT-EXO group (action observation treatment-based exoskeleton therapy). The patients will undergo blinded assessments at baseline, post-intervention (after 4 weeks) and follow-up (after 12 weeks). The primary outcome will be the Fugl-Meyer Assessment for Upper Extremity (FMA-UE). Secondary outcomes will include the Action Research Arm Test (ARAT), modified Barthel Index (MBI), kinematic metrics assessed by inertial measurement unit (IMU), resting motor threshold (rMT), motor evoked potentials (MEP), functional magnetic resonance imaging (fMRI) and safety outcomes. DISCUSSION This trial will provide evidence regarding the feasibility and efficacy of the action observation treatment-based exoskeleton (AOT-EXO) for post-stroke upper extremity rehabilitation and elucidate the potential underlying kinematic and neurological mechanisms. TRIAL REGISTRATION Chinese Clinical Trial Registry ChiCTR1900026656 . Registered on 17 October 2019.",2021,"Secondary outcomes will include the Action Research Arm Test (ARAT), modified Barthel Index (MBI), kinematic metrics assessed by inertial measurement unit (IMU), resting motor threshold (rMT), motor evoked potentials (MEP), functional magnetic resonance imaging (fMRI) and safety outcomes. ","['132 eligible patients in the trial implemented in the Department of Rehabilitation Medicine of Tongji Hospital, Optical Valley Branch of Tongji Hospital and Hubei Province Hospital of Integrated Chinese & Western Medicine in Wuhan, China', 'enrolled stroke patients', 'eligible patients in accordance with the Declaration of Helsinki', 'upper extremity after stroke']","['CT group (conventional therapy); EXO group (exoskeleton therapy) and AOT-EXO group (action observation treatment-based exoskeleton therapy', 'Robot-assisted training', 'robot-assisted training', 'Action observation treatment-based exoskeleton (AOT-EXO', 'action observation treatment-based exoskeleton (AOT-EXO']","['Fugl-Meyer Assessment for Upper Extremity (FMA-UE', 'Action Research Arm Test (ARAT), modified Barthel Index (MBI), kinematic metrics assessed by inertial measurement unit (IMU), resting motor threshold (rMT), motor evoked potentials (MEP), functional magnetic resonance imaging (fMRI) and safety outcomes', 'motor circuit activation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0031813', 'cui_str': 'Physical Medicine and Rehabilitation'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0563004', 'cui_str': 'Valley'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018898', 'cui_str': 'Declaration of Helsinki'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C4720875', 'cui_str': 'Action research arm test'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0765592,"Secondary outcomes will include the Action Research Arm Test (ARAT), modified Barthel Index (MBI), kinematic metrics assessed by inertial measurement unit (IMU), resting motor threshold (rMT), motor evoked potentials (MEP), functional magnetic resonance imaging (fMRI) and safety outcomes. ","[{'ForeName': 'Zejian', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Xia', 'Affiliation': 'Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'He', 'Affiliation': 'Institute of Rehabilitation and Medical Robotics, State Key Lab of Digital Manufacturing Equipment and Technology, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Minghui', 'Initials': 'M', 'LastName': 'Gu', 'Affiliation': 'Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xiaohua', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. hanxiao1470@hust.edu.cn.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. xiaolinh2006@126.com.'}]",Trials,['10.1186/s13063-021-05176-x'] 2549,33742104,Precision medicine: preliminary results from the Initiative for Molecular Profiling and Advanced Cancer Therapy 2 (IMPACT2) study.,"Precision medicine is associated with favorable outcomes in selected patients with cancer. Herein, we report an interim analysis of IMPACT2, an ongoing randomized study evaluating genomic profiling and targeted agents in metastatic cancer. Patients with metastatic cancer underwent tumor genomic profiling (ClinialTrials.gov: NCT02152254), and 69 patients met the criteria for randomization. Tumor board and multidisciplinary review of molecular alterations optimized treatment selection. From 5/2014 to 4/2017, 320 patients (median age, 63 years; men, 47%) had tumor molecular aberrations, and 213 (66.56%) received anticancer therapy. The most frequently mutated genes were TP53 (42%), KRAS (16%), PIK3CA (12%), and CDKN2A (11%). The median OS was 10.9 months (95% CI, 8.8-12.9). OS was shorter in patients with higher tumor mutational burden. Independent factors associated with shorter OS were age ≥60 years, liver metastases, low albumin levels, high LDH levels, and KRAS and TP53 mutations. Outcomes for randomized patients will be reported after completion of the study.",2021,OS was shorter in patients with higher tumor mutational burden.,"['Patients with metastatic cancer underwent tumor genomic profiling (ClinialTrials.gov: NCT02152254), and 69 patients met the criteria for randomization', 'metastatic cancer', '320 patients (median age, 63 years; men, 47%) had tumor molecular aberrations, and 213 (66.56%) received', 'selected patients with cancer']","['IMPACT2', 'anticancer therapy']",['median OS'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}]",320.0,0.114,OS was shorter in patients with higher tumor mutational burden.,"[{'ForeName': 'Apostolia Maria', 'Initials': 'AM', 'LastName': 'Tsimberidou', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Department of Investigational Cancer Therapeutics, Houston, TX, USA. atsimber@mdanderson.org.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Hong', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Department of Investigational Cancer Therapeutics, Houston, TX, USA.'}, {'ForeName': 'Siqing', 'Initials': 'S', 'LastName': 'Fu', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Department of Investigational Cancer Therapeutics, Houston, TX, USA.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Karp', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Department of Investigational Cancer Therapeutics, Houston, TX, USA.'}, {'ForeName': 'Sarina', 'Initials': 'S', 'LastName': 'Piha-Paul', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Department of Investigational Cancer Therapeutics, Houston, TX, USA.'}, {'ForeName': 'Merrill S', 'Initials': 'MS', 'LastName': 'Kies', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Department of Thoracic, Head and Neck Medical Oncology, Houston, TX, USA.'}, {'ForeName': 'Vinod', 'Initials': 'V', 'LastName': 'Ravi', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Department of Sarcoma Medical Oncology, Houston, TX, USA.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Subbiah', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Department of Investigational Cancer Therapeutics, Houston, TX, USA.'}, {'ForeName': 'Sunil M', 'Initials': 'SM', 'LastName': 'Patel', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Regional Cancer Center in Katy, TX; current affiliation: Kelsey Seybold Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Shi-Ming', 'Initials': 'SM', 'LastName': 'Tu', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Department of Genitourinary Medical Oncology, Houston, TX, USA.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Janku', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Department of Investigational Cancer Therapeutics, Houston, TX, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Heymach', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Department of Thoracic, Head and Neck Medical Oncology, Houston, TX, USA.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Johnson', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Sheikh Khalifa Bin Zayed Al Nahyan Institute for Personalized Cancer Therapy, Houston, TX, USA.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Cartwright', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Department of Investigational Cancer Therapeutics, Houston, TX, USA.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Department of Genomic Medicine, Houston, TX, USA.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Department of Genomic Medicine, Houston, TX, USA.'}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Berry', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Department of Biostatistics, Houston, TX, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Vining', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Department of Abdominal Imaging, Houston, TX, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Futreal', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Department of Genomic Medicine, Houston, TX, USA.'}, {'ForeName': 'Vincent A', 'Initials': 'VA', 'LastName': 'Miller', 'Affiliation': 'Foundation Medicine, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Funda', 'Initials': 'F', 'LastName': 'Meric-Bernstam', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Department of Investigational Cancer Therapeutics, Houston, TX, USA.'}]",NPJ precision oncology,['10.1038/s41698-021-00159-2'] 2550,33653769,Post Discharge after Surgery Virtual Care with Remote Automated Monitoring Technology (PVC-RAM): protocol for a randomized controlled trial.,"BACKGROUND After nonelective (i.e., semiurgent, urgent and emergent) surgeries, patients discharged from hospitals are at risk of readmissions, emergency department visits or death. During the coronavirus disease 2019 (COVID-19) pandemic, we are undertaking the Post Discharge after Surgery Virtual Care with Remote Automated Monitoring Technology (PVC-RAM) trial to determine if virtual care with remote automated monitoring (RAM) compared with standard care will increase the number of days adult patients remain alive at home after being discharged following nonelective surgery. METHODS We are conducting a randomized controlled trial in which 900 adults who are being discharged after nonelective surgery from 8 Canadian hospitals are randomly assigned to receive virtual care with RAM or standard care. Outcome adjudicators are masked to group allocations. Patients in the experimental group learn how to use the study's tablet computer and RAM technology, which will measure their vital signs. For 30 days, patients take daily biophysical measurements and complete a recovery survey. Patients interact with nurses via the cellular modem-enabled tablet, who escalate care to preassigned and available physicians if RAM measurements exceed predetermined thresholds, patients report symptoms, a medication error is identified or the nurses have concerns they cannot resolve. The primary outcome is number of days alive at home during the 30 days after randomization. INTERPRETATION This trial will inform management of patients after discharge following surgery in the COVID-19 pandemic and offer insights for management of patients who undergo nonelective surgery in a nonpandemic setting. Knowledge dissemination will be supported through an online multimedia resource centre, policy briefs, presentations, peer-reviewed journal publications and media engagement. TRIAL REGISTRATION ClinicalTrials.gov, no. NCT04344665.",2021,"Knowledge dissemination will be supported through an online multimedia resource centre, policy briefs, presentations, peer-reviewed journal publications and media engagement. ","['patients who undergo nonelective surgery in a nonpandemic setting', '900 adults who are being discharged after nonelective surgery from 8 Canadian hospitals', 'days adult patients remain alive at home after being discharged following nonelective surgery']","['virtual care with RAM or standard care', 'virtual care with remote automated monitoring (RAM']",['number of days alive at home during the 30 days after randomization'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",900.0,0.308015,"Knowledge dissemination will be supported through an online multimedia resource centre, policy briefs, presentations, peer-reviewed journal publications and media engagement. ","[{'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'McGillion', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Parlow', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Flavia K', 'Initials': 'FK', 'LastName': 'Borges', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Marcucci', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Jacka', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Adili', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Manoj M', 'Initials': 'MM', 'LastName': 'Lalu', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Homer', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Ameen', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': ""O'Leary"", 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Tandon', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Gavin M', 'Initials': 'GM', 'LastName': 'Hamilton', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Mrkobrada', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Carley', 'Initials': 'C', 'LastName': 'Ouellette', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Bird', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Ofori', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Conen', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Pavel S', 'Initials': 'PS', 'LastName': 'Roshanov', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Harvey', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Gordon H', 'Initials': 'GH', 'LastName': 'Guyatt', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Le Manach', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Shrikant I', 'Initials': 'SI', 'LastName': 'Bangdiwala', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Ramiro', 'Initials': 'R', 'LastName': 'Arellano', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Ted', 'Initials': 'T', 'LastName': 'Scott', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Lounsbury', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Dylan A', 'Initials': 'DA', 'LastName': 'Taylor', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Rahima', 'Initials': 'R', 'LastName': 'Nenshi', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Forster', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Nagappa', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Lamy', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Peter', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Kelsea', 'Initials': 'K', 'LastName': 'Levesque', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Marosi', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Sultan', 'Initials': 'S', 'LastName': 'Chaudhry', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Shariq', 'Initials': 'S', 'LastName': 'Haider', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Lesly', 'Initials': 'L', 'LastName': 'Deuchar', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Brandi', 'Initials': 'B', 'LastName': 'LeBlanc', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Colin J L', 'Initials': 'CJL', 'LastName': 'McCartney', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Emil H', 'Initials': 'EH', 'LastName': 'Schemitsch', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Vincent', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Shirley M', 'Initials': 'SM', 'LastName': 'Pettit', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Paul', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'DuMerton', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Angela Djuric', 'Initials': 'AD', 'LastName': 'Paulin', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Simunovic', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Williams', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Halman', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Schlachta', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Shelley', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Harlock', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Ralph M', 'Initials': 'RM', 'LastName': 'Meyer', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Graham', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Harsha', 'Initials': 'H', 'LastName': 'Shanthanna', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Parry', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Pichora', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Haroon', 'Initials': 'H', 'LastName': 'Yousef', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Husein', 'Initials': 'H', 'LastName': 'Moloo', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'Sehmbi', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Waggott', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Emilie P', 'Initials': 'EP', 'LastName': 'Belley-Cote', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Whitlock', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont.""}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Devereaux', 'Affiliation': ""School of Nursing (McGillion, Levesque, Lounsbury, Bird, Ouellette), McMaster University, Hamilton, Ont.; Population Health Research Institute (McGillion, Whitlock, Devereaux, Belley-Cote, Borges, Vincent, Lamy, Bangdiwala, Le Manach, Harvey, Conen), Hamilton, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Arellano), Queen's University, Kingston, Ont.; Department of Anesthesiology and Perioperative Medicine (Parlow, Shelley, DuMerton, Arellano), Kingston Health Sciences Centre, Kingston, Ont.; Department of Medicine (Belley-Cote, Yousef, Borges, Marcucci, Chaudhry, Haider, Guyatt, Patel, Conen, Tandon), McMaster University, Hamilton, Ont.; Department of Health Research Methods, Evidence, and Impact (Whitlock, Devereaux, Marcucci, Bangdiwala, Guyatt), McMaster University, Hamilton, Ont.; Departments of Critical Care and Anesthesiology (Jacka), University of Alberta, Edmonton, Alta.; Department of Surgery (Adili, Harlock, Simunovic, Nenshi), McMaster University, Hamilton, Ont.; St. Joseph's Healthcare Hamilton (Adili, LeBlanc, Nenshi, Tandon), Hamilton, Ont.; Department of Anesthesiology and Pain Medicine (Lalu, McCartney, Hamilton), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Ottawa Hospital Research Institute (Moloo, Lalu, Halman, Forster, Hamilton), Ottawa, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Anesthesia and Perioperative Medicine (Sehmbi, Nagappa, Yang), London Health Sciences Centre, London, Ont.; Hamilton Health Sciences (Meyer, Paulin, Pettit, Lamy, Lounsbury, Scott, Patel, Ouellette, O'Leary), Hamilton, Ont.; Department of Anesthesia (Shanthanna, Paul, Le Manach, O'Leary), McMaster University, Hamilton, Ont.; Department of Medicine (Roshanov, Mrkobrada), Schulich School of Medicine, University of Western Ontario, London, Ont.; Department of Internal Medicine (Ofori), University of Port Harcourt, Port Harcourt, Nigeria, West Africa; Department of Medicine (Graham, Taylor), University of Alberta, Edmonton, Alta.; Department of Medicine (Halman, Forster), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; Lawrence S. Bloomberg Faculty of Nursing (Peter), University of Toronto, Toronto, Ont.; Department of Medicine (Marosi), Queen's University, Kingston, Ont.; Alberta Health Services (Deuchar), Alberta, Canada; Department of Surgery (Parry, Schlachta, Schemitsch), University of Western Ontario and London Health Sciences Centre, London, Ont.; Department of Surgery (Williams), University of Alberta, Edmonton, Alta.; Department of Oncology (Meyer), McMaster University, Hamilton, Ont.; Department of Surgery (Pichora), Queen's University and Kingston Health Sciences Centre, Kingston, Ont.; Department of Surgery (Moloo), University of Ottawa and The Ottawa Hospital, Ottawa, Ont.; The Ottawa Hospital (Waggott), Ottawa, Ont. p.j.devereaux@phri.ca.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",CMAJ open,['10.9778/cmajo.20200176'] 2551,33725939,To clip or to coil for unruptured intracranial aneurysm?: A protocol of randomized controlled trial.,"INTRODUCTION Microsurgical clipping and endovascular coiling are the main methods against unruptured intracranial aneurysm (UIA). The craniotomy of surgical clipping may increase the risk of cerebrospinal fluid leakage and infection, damage the brain tissue, produce excessive stimulation to the nerves and blood vessels around the aneurysm, and cause the corresponding neurological deficit. Endovascular coiling could significantly reduce the mortality and disability rate than surgical clipping technique, which made endovascular coiling to become the first choice for the treatment of UIA. However, the long-term results showed attenuated favorable outcomes of coiling over clipping, so it is still in debate whether to clip or to coil. Therefore, we try to conduct a randomized, controlled, prospective trial to assess the long term safety of endovascular coiling therapy against UIA compared with microsurgical clipping technique. METHODS Parallel-group randomization (1:1) is generated through the random number generator in Microsoft Excel 2010. In this trial, blinding to patients, physicians, and outcome assessors is not possible. Endovascular coiling or surgical clipping will be performed once for each patient in treatment group or control group, respectively. The mRS, overall mortality rate, disability rate, morbidity rate, and occurrence of a major aneurysm recurrence measured at 6 month and 1 year will be recorded. CONCLUSIONS The findings will be helpful for the choice of endovascular coiling or surgical clipping by assessing the long term efficacy and safety of both operations against UIA. TRIAL REGISTRATION OSF Registration number: DOI 10.17605/OSF.IO/QYE9F.",2021,"Endovascular coiling could significantly reduce the mortality and disability rate than surgical clipping technique, which made endovascular coiling to become the first choice for the treatment of UIA.",['OSF Registration number'],"['DOI 10.17605/OSF.IO/QYE9F', 'Microsurgical clipping and endovascular coiling', 'endovascular coiling therapy against UIA', 'microsurgical clipping technique', 'Endovascular coiling or surgical clipping']","['mortality and disability rate', 'mRS, overall mortality rate, disability rate, morbidity rate, and occurrence of a major aneurysm recurrence']","[{'cui': 'C0237753', 'cui_str': 'Number'}]","[{'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0007766', 'cui_str': 'Intracranial aneurysm'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.241543,"Endovascular coiling could significantly reduce the mortality and disability rate than surgical clipping technique, which made endovascular coiling to become the first choice for the treatment of UIA.","[{'ForeName': 'Xiaoshan', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': ""Huizhou Central People's Hospital, Huizhou, Guangdong province, China.""}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Yan', 'Affiliation': ''}, {'ForeName': 'Zhongzong', 'Initials': 'Z', 'LastName': 'Qin', 'Affiliation': ''}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Zhu', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000024692'] 2552,33727260,A Randomized Phase II Study of Androgen Deprivation Therapy with or without Palbociclib in RB-positive Metastatic Hormone-Sensitive Prostate Cancer.,"PURPOSE Palbociclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor, blocks proliferation in a RB and cyclin D-dependent manner in preclinical prostate cancer models. We hypothesized that cotargeting androgen receptor and cell cycle with palbociclib would improve outcomes in patients with metastatic hormone-sensitive prostate cancer (mHSPC). EXPERIMENTAL DESIGN A total of 60 patients with RB-intact mHSPC were randomized (1:2) to Arm 1: androgen deprivation (AD) or Arm 2: AD + palbociclib. Primary endpoint was PSA response rate (RR) after 28 weeks of therapy. Secondary endpoints included safety, PSA, and clinical progression-free survival (PFS), as well as PSA and radiographic RR. Tumors underwent exome sequencing when available. Circulating tumor cells (CTC) were enumerated at various timepoints. RESULTS A total of 72 patients with mHSPC underwent metastatic disease biopsy and 64 had adequate tissue for RB assessment. A total of 62 of 64 (97%) retained RB expression. A total of 60 patients initiated therapy (Arm 1: 20; Arm 2: 40). Neutropenia was the most common grade 3/4 adverse event in Arm 2. Eighty percent of patients (Arm 1: 16/20, Arm 2: 32/40; P = 0.87) met primary PSA endpoint ≤4 ng/mL at 28 weeks. PSA undetectable rate at 28 weeks was 50% and 43% in Arms 1 and 2, respectively ( P = 0.5). Radiographic RR was 89% in both arms. Twelve-month biochemical PFS was 69% and 74% in Arms 1 and 2, respectively ( P = 0.72). TP53 and PIK3 pathway mutations, 8q gains, and pretreatment CTCs were associated with reduced PSA PFS. CONCLUSIONS Palbociclib did not impact outcome in RB-intact mHSPC. Pretreatment CTC, TP53 and PIK3 pathway mutations, and 8q gain were associated with poor outcome.",2021,"12 month biochemical PFS was 69% and 74% in Arms 1 and 2, respectively (p=0.72).","['72 patients with mHSPC underwent metastatic disease biopsy and 64 had adequate tissue for RB assessment', '60 patients with Rb-intact mHSPC', '60 patients initiated therapy (Arm 1: 20; Arm 2: 40', 'RB-positive Metastatic Hormone Sensitive Prostate Cancer (mHSPC', 'patients with metastatic hormone-sensitive prostate cancer (mHSPC']","['palbociclib (a CDK4/6 inhibitor', 'Androgen Deprivation Therapy with or without Palbociclib', 'androgen deprivation (AD) or Arm 2: AD+ palbociclib']","['Neutropenia', 'Radiographic RR', 'safety, PSA and clinical progression-free survival (PFS), PSA and radiographic RR', 'RB expression', 'PSA response rate (RR', 'PSA undetectable rate', 'Circulating tumor cells (CTC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]","[{'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}]",60.0,0.186481,"12 month biochemical PFS was 69% and 74% in Arms 1 and 2, respectively (p=0.72).","[{'ForeName': 'Phillip L', 'Initials': 'PL', 'LastName': 'Palmbos', 'Affiliation': 'Michigan Medicine Rogel Cancer Center, Ann Arbor, Michigan.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Daignault-Newton', 'Affiliation': 'Michigan Medicine Rogel Cancer Center, Ann Arbor, Michigan.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Tomlins', 'Affiliation': 'Michigan Medicine Rogel Cancer Center, Ann Arbor, Michigan.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Agarwal', 'Affiliation': 'Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Przemyslaw', 'Initials': 'P', 'LastName': 'Twardowski', 'Affiliation': 'City of Hope Cancer Center, Duarte, California.'}, {'ForeName': 'Alicia K', 'Initials': 'AK', 'LastName': 'Morgans', 'Affiliation': 'Northwestern University/Robert H. Lurie Comprehensive Cancer Center, Chicago, Illinois.'}, {'ForeName': 'Wm Kevin', 'Initials': 'WK', 'LastName': 'Kelly', 'Affiliation': 'Sidney Kimmel Cancer Center at Jefferson Health and Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Vivek K', 'Initials': 'VK', 'LastName': 'Arora', 'Affiliation': 'Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Emmanuel S', 'Initials': 'ES', 'LastName': 'Antonarakis', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at John Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Siddiqui', 'Affiliation': 'Michigan Medicine Rogel Cancer Center, Ann Arbor, Michigan.'}, {'ForeName': 'Jon A', 'Initials': 'JA', 'LastName': 'Jacobson', 'Affiliation': 'Michigan Medicine Rogel Cancer Center, Ann Arbor, Michigan.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Davenport', 'Affiliation': 'Michigan Medicine Rogel Cancer Center, Ann Arbor, Michigan.'}, {'ForeName': 'Dan R', 'Initials': 'DR', 'LastName': 'Robinson', 'Affiliation': 'Michigan Medicine Rogel Cancer Center, Ann Arbor, Michigan.'}, {'ForeName': 'Arul M', 'Initials': 'AM', 'LastName': 'Chinnaiyan', 'Affiliation': 'Michigan Medicine Rogel Cancer Center, Ann Arbor, Michigan.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Knudsen', 'Affiliation': 'Sidney Kimmel Cancer Center at Jefferson Health and Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'Northwestern University/Robert H. Lurie Comprehensive Cancer Center, Chicago, Illinois. maha.hussain@northwestern.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-21-0024'] 2553,33689903,Fatigue failure of anterior teeth without ferrule restored with individualized fiber-reinforced post-core foundations.,"OBJECTIVES The aim was to explore the survival of extensively damaged anterior teeth without ferrule restored with different fiber-reinforced composite (FRC) post-core foundations and composite crowns. MATERIALS AND METHODS Sixty extracted upper central incisors were decoronated and randomly divided into four groups (n = 15). After endodontic treatment, the specimens were restored with different individualized fiber-reinforced post-core foundations as follows: control group (CTRL): multiple unidirectional FRC-post + dual-cure composite-core, PFC: multiple unidirectional FRC-post + packable short fiber-reinforced composite (SFRC), BPFC: Bioblock technique with only packable SFRC, BFFC: Bioblock technique with only flowable SFRC. After core build-up, the teeth were finalized with adhesively luted CAD/CAM composite crowns. Cyclic isometric loading (5 Hz) was applied at 100 N for 5000 cycles, and then 200 N and 300 N for 15,000 cycles each in a fluid chamber. The specimens were loaded until fracture occurred or when a total of 35,000 cycles were reached. Kaplan-Meyer survival analysis was conducted, followed by pairwise log-rank post hoc comparisons (Mantel-Cox). RESULTS The survival rates of the control (8279 cycles) and PFC (6161 cycles) were significantly higher compared to BPFC (3223 cycles) and BFFC (2271 cycles) (p < 0.05). Regarding fracture pattern, nearly all specimens fractured in a restorable manner. CONCLUSIONS For restoring extensively damaged anterior teeth, multiple unidirectional FRC posts are recommended. CLINICAL RELEVANCE Although different FRC post/core systems are available for the restoration of damaged root canal treated anterior teeth, multiple unidirectional FRC posts tend to be a good option when the ferrule is missing.",2021,The survival rates of the control (8279 cycles) and PFC (6161 cycles) were significantly higher compared to BPFC (3223 cycles) and BFFC (2271 cycles) (p < 0.05).,['Sixty extracted upper central incisors'],"['control group (CTRL): multiple unidirectional FRC-post\xa0+\xa0dual-cure composite-core, PFC: multiple unidirectional FRC-post\xa0+\xa0packable short fiber-reinforced composite (SFRC), BPFC: Bioblock technique with only packable SFRC, BFFC: Bioblock technique with only flowable SFRC', 'Cyclic isometric loading (5\xa0Hz', 'individualized fiber-reinforced post-core foundations']","['survival rates', 'survival', 'Fatigue failure']","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",60.0,0.051732,The survival rates of the control (8279 cycles) and PFC (6161 cycles) were significantly higher compared to BPFC (3223 cycles) and BFFC (2271 cycles) (p < 0.05).,"[{'ForeName': 'Márk', 'Initials': 'M', 'LastName': 'Fráter', 'Affiliation': 'Department of Operative and Esthetic Dentistry, Faculty of Dentistry, University of Szeged, Szeged, Hungary. Electronic address: meddentist.fm@gmail.com.'}, {'ForeName': 'Tekla', 'Initials': 'T', 'LastName': 'Sáry', 'Affiliation': 'Department of Operative and Esthetic Dentistry, Faculty of Dentistry, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Braunitzer', 'Affiliation': 'DicomLAB Dental Ltd., Szeged, Hungary.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Balázs Szabó', 'Affiliation': 'Department of Food Engineering, Faculty of Engineering, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Lippo', 'Initials': 'L', 'LastName': 'Lassila', 'Affiliation': 'Department of Biomaterials Science and Turku Clinical Biomaterials Center -TCBC Institute of Dentistry, University of Turku, Turku, Finland.'}, {'ForeName': 'Pekka K', 'Initials': 'PK', 'LastName': 'Vallittu', 'Affiliation': 'Department of Biomaterials Science and Turku Clinical Biomaterials Center -TCBC Institute of Dentistry, University of Turku, Turku, Finland; City of Turku Welfare Division, Oral Health Care, Turku, Finland.'}, {'ForeName': 'Sufyan', 'Initials': 'S', 'LastName': 'Garoushi', 'Affiliation': 'Department of Biomaterials Science and Turku Clinical Biomaterials Center -TCBC Institute of Dentistry, University of Turku, Turku, Finland.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2021.104440'] 2554,33737443,Epley manoeuvre for posterior semicircular canal benign paroxysmal positional vertigo in people with multiple sclerosis: protocol of a randomised controlled trial.,"INTRODUCTION Vestibular disorders in multiple sclerosis (MS) could have central or peripheral origin. Although the central aetiology is the most expected in MS, peripheral damage is also significant in this disease. The most prevalent effect of vestibular peripheral damage is benign paroxysmal positional vertigo (BPPV). Impairments of the posterior semicircular canals represent 60%-90% of cases of BPPV. The standard gold treatment for this syndrome is the Epley manoeuvre (EM), the effectiveness of which has been poorly studied in patients with MS. Only one retrospective research study and a case study have reported encouraging results for EM with regard to resolution of posterior semicircular canal BPPV. The aim of this future randomised controlled trial (RCT) is to assess the effectiveness of EM for BPPV in participants with MS compared with a sham manoeuvre. METHODS AND ANALYSIS The current protocol describes an RCT with two-arm, parallel-group design. Randomisation, concealed allocation and double-blinding will be conducted to reduce possible bias. Participants and evaluators will be blinded to group allocation. At least 80 participants who meet all eligibility criteria will be recruited. Participants will have the EM or sham manoeuvre performed within the experimental or control group, respectively. The primary outcome of the study is changes in the Dix Hallpike test. The secondary outcome will be changes in self-perceived scales: Dizziness Handicap Inventory and Vestibular Disorders Activities of Daily Living Scale. The sample will be evaluated at baseline, immediately after the intervention and 48 hours postintervention. ETHICS AND DISSEMINATION The study was approved by the Andalusian Review Board and Ethics Committee of Virgen Macarena-Virgen del Rocio Hospitals (ID 0107-N-20, 23 July 2020). The results of the research will be disseminated by the investigators to peer-reviewed journals. TRIAL REGISTRATION NUMBER NCT04578262.",2021,"The aim of this future randomised controlled trial (RCT) is to assess the effectiveness of EM for BPPV in participants with MS compared with a sham manoeuvre. ","['At least 80 participants who meet all eligibility criteria will be recruited', 'patients with MS', 'posterior semicircular canal benign paroxysmal positional vertigo in people with multiple sclerosis', 'participants with MS']",['Epley manoeuvre'],"['changes in self-perceived scales: Dizziness Handicap Inventory and Vestibular Disorders Activities of Daily Living Scale', 'Dix Hallpike test']","[{'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0229454', 'cui_str': 'Structure of posterior semicircular duct'}, {'cui': 'C0155502', 'cui_str': 'Benign paroxysmal positional vertigo'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1279393', 'cui_str': 'Epley maneuver'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0042594', 'cui_str': 'Vestibular disorder'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.430026,"The aim of this future randomised controlled trial (RCT) is to assess the effectiveness of EM for BPPV in participants with MS compared with a sham manoeuvre. ","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'García-Muñoz', 'Affiliation': 'Department of Physiotherapy, University of Seville, Sevilla, Spain.'}, {'ForeName': 'Maria-Dolores', 'Initials': 'MD', 'LastName': 'Cortes-Vega', 'Affiliation': 'Department of Physiotherapy, University of Seville, Sevilla, Spain mdcortes@us.es.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Hernández-Rodríguez', 'Affiliation': 'Dermatology Department, Hospital Universitario Virgen del Rocío, Sevilla, Spain.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Palomo-Carrión', 'Affiliation': 'Department of Nursery, Physiotherapy and Occupational Therapy, Universidad de Castilla-La Mancha, Toledo, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Martín-Valero', 'Affiliation': 'Department of Physiotherapy, University of Malaga, Malaga, Spain.'}, {'ForeName': 'María Jesús', 'Initials': 'MJ', 'LastName': 'Casuso-Holgado', 'Affiliation': 'Department of Physiotherapy, University of Seville, Sevilla, Spain.'}]",BMJ open,['10.1136/bmjopen-2020-046510'] 2555,33737211,"Sensory-specific satiety, the variety effect and physical context: Does change of context during a meal enhance food intake?","Food variety has been shown to increase food intake, and sensory-specific satiety (a relative decrease in pleasantness of a food as it is consumed) has been proposed as the mechanism through which variety increases consumption. The aim of this study was to investigate whether variation of eating context can add to experienced meal variety and hence increase consumption even further. A total of 128 participants were assigned to one of four conditions in which they first ate a specific food item (ad libitum) until satiated, after which they consumed a second course ad libitum of either the same or a different food in either the same context or in a different context. We hypothesized that, compared to eating the same food in the same context during the second course, introducing a different food item or changing the context for the second course increases consumption (of the second course), and changing both food and context enhances food intake to a greater degree than only changing the food or changing the context. Results indicated that food variety (introducing a different food) significantly increased consumption in the second course, but that a context switch did not enhance consumption. These results suggest that there is little reason to believe that sensory-specific satiety is context specific.",2021,"Results indicated that food variety (introducing a different food) significantly increased consumption in the second course, but that a context switch did not enhance consumption.",['128 participants'],[],[],[],[],[],128.0,0.0958439,"Results indicated that food variety (introducing a different food) significantly increased consumption in the second course, but that a context switch did not enhance consumption.","[{'ForeName': 'Anouk E M', 'Initials': 'AEM', 'LastName': 'Hendriks', 'Affiliation': 'Laboratory of Behavioural Gastronomy, Centre for Healthy Eating and Food Innovation, Maastricht University Campus Venlo, the Netherlands. Electronic address: anouk.hendriks@maastrichtuniversity.nl.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Nederkoorn', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology & Neuroscience, Maastricht University, the Netherlands.'}, {'ForeName': 'Ilse M J', 'Initials': 'IMJ', 'LastName': 'van Lier', 'Affiliation': 'Faculty of Health, Medicine and Life Sciences, Maastricht University Campus Venlo, the Netherlands.'}, {'ForeName': 'Britt', 'Initials': 'B', 'LastName': 'van Belkom', 'Affiliation': 'Chair Youth, Food, and Health, Maastricht University Campus Venlo, the Netherlands.'}, {'ForeName': 'Aalt', 'Initials': 'A', 'LastName': 'Bast', 'Affiliation': 'Department of Pharmacology & Toxicology, School of Nutrition and Translational Research in Metabolism, Faculty of Health, Medicine and Life Sciences, Maastricht University Campus Venlo, the Netherlands.'}, {'ForeName': 'Remco C', 'Initials': 'RC', 'LastName': 'Havermans', 'Affiliation': 'Laboratory of Behavioural Gastronomy, Centre for Healthy Eating and Food Innovation, Maastricht University Campus Venlo, the Netherlands; Chair Youth, Food, and Health, Maastricht University Campus Venlo, the Netherlands.'}]",Appetite,['10.1016/j.appet.2021.105179'] 2556,33734910,Comparison of the Intraocular Pressure-Lowering Effect and Safety of Preservative-Free And Preservative-Containing Brimonidine/Timolol Fixed-Combination Ophthalmic Solutions in Patients with Open-Angle Glaucoma.,"Purpose : To compare the therapeutic efficacy and safety of newly developed preservative-free (PF) brimonidine/timolol fixed-combination (BTFC) ophthalmic solutions and a preservative-containing (PC) BTFC ophthalmic solution in patients with open-angle glaucoma. Methods : This study was conducted as a multicenter, randomized, open-label, parallel-group clinical trial to evaluate the efficacy and safety of PF BTFC as compared with PC BTFC in adult patients (aged ≥ 19 years) with open-angle glaucoma (OAG) and ocular hypertension (OHT). A total of the 106 patients were enrolled, with 53 patients each randomized to the two treatment groups and included in the analysis of the safety set (SS).After a washout period, patients with an IOP below 35 mmHg at 9 a.m. were enrolled. After a full ophthalmic and glaucoma examination, a total of 106 OAG and OHT patients were randomized to the PF group or PC group.All subjects were examined 4 and 12 weeks after first administration. At each follow-up visit, IOP was measured at 9 a.m. and 11 a.m. and the efficacy, safety, and compliance were evaluated. Throughout the study, all adverse events were recorded and monitored by the investigators. Results The mean IOP changes from baseline to 12 weeks at 11:00 a.m. were -3.45 ± 2.53 mmHg in the PF group and -3.65 ± 2.76 mmHg in the PC group ( p < .0001 for both). The difference in mean IOP change between the two groups was 0.20 ± 2.65 mmHg, which was not significantly different. The proportion of patients with IOP reductions of ≥ 15% and ≥ 20% and IOP at all-time points in the PF group were not significantly different when compared with in the PC group. There were no specific differences between the two groups regarding the incidence of adverse events. Conclusions PF BTFC ophthalmic solution shows a similar efficacy and safety profile to that of PC BTFC.",2021,There were no specific differences between the two groups regarding the incidence of adverse events.,"['106 OAG and OHT patients', 'patients with open-angle glaucoma', '106 patients were enrolled, with 53 patients each randomized to the two treatment groups and included in the analysis of the safety set (SS).After a washout period, patients with an IOP below 35\xa0mmHg at 9 a.m. were enrolled', 'Patients with Open-Angle Glaucoma', 'adult patients (aged ≥ 19\xa0years) with open-angle glaucoma (OAG) and ocular hypertension (OHT']","['PC BTFC', 'newly developed preservative-free (PF) brimonidine/timolol fixed-combination (BTFC) ophthalmic solutions and a preservative-containing (PC) BTFC ophthalmic solution', 'PF group or PC', 'PF BTFC', 'Preservative-Free And Preservative-Containing Brimonidine/Timolol Fixed-Combination Ophthalmic Solutions']","['IOP reductions', 'efficacy, safety, and compliance', 'mean IOP changes', 'mean IOP change', 'therapeutic efficacy and safety', 'incidence of adverse events']","[{'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C0028840', 'cui_str': 'Ocular hypertension'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0033086', 'cui_str': 'Drug preservative'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1563133', 'cui_str': 'Brimonidine- and timolol-containing product'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",106.0,0.0857647,There were no specific differences between the two groups regarding the incidence of adverse events.,"[{'ForeName': 'Joon Mo', 'Initials': 'JM', 'LastName': 'Kim', 'Affiliation': 'Department of Ophthalmology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Tae-Woo', 'Initials': 'TW', 'LastName': 'Kim', 'Affiliation': 'Department of Ophthalmology , Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Sang-Woo', 'Initials': 'SW', 'LastName': 'Park', 'Affiliation': 'Department of Ophthalmology and Research Institute of Medical Sciences, Chonnam National University Medical School and Hospital, Gwangju, Republic of Korea.'}, {'ForeName': 'Hae-Young Lopilly', 'Initials': 'HL', 'LastName': 'Park', 'Affiliation': ""Department of Ophthalmology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Young Hoon', 'Initials': 'YH', 'LastName': 'Hwang', 'Affiliation': 'Department of Ophthalmology, Chungnam National University Hospital, Daejeon, Republic of Korea.'}, {'ForeName': 'Jin Wook', 'Initials': 'JW', 'LastName': 'Jeoung', 'Affiliation': 'Department of Ophthalmology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Chan Yun', 'Initials': 'CY', 'LastName': 'Kim', 'Affiliation': 'Department of Ophthalmology, Severance Hospital Institute of Vision Research, Yonsei University College of Medicine, Seoul, Republic of Korea.'}]",Seminars in ophthalmology,['10.1080/08820538.2021.1885722'] 2557,33734835,Critical Care Requirements Under Uncontrolled Transmission of SARS-CoV-2.,"Objectives. To estimate the critical care bed capacity that would be required to admit all critical COVID-19 cases in a setting of unchecked SARS-CoV-2 transmission, both with and without elderly-specific protection measures. Methods. Using electronic health records of all 2432 COVID-19 patients hospitalized in a large hospital in Madrid, Spain, between February 28 and April 23, 2020, we estimated the number of critical care beds needed to admit all critical care patients. To mimic a hypothetical intervention that halves SARS-CoV-2 infections among the elderly, we randomly excluded 50% of patients aged 65 years and older. Results. Critical care requirements peaked at 49 beds per 100 000 on April 1-2 weeks after the start of a national lockdown. After randomly excluding 50% of elderly patients, the estimated peak was 39 beds per 100 000. Conclusions. Under unchecked SARS-CoV-2 transmission, peak critical care requirements in Madrid were at least fivefold higher than prepandemic capacity. Under a hypothetical intervention that halves infections among the elderly, critical care peak requirements would have exceeded the prepandemic capacity of most high-income countries. Public Health Implications. Pandemic control strategies that rely exclusively on protecting the elderly are likely to overwhelm health care systems.",2021,Critical care requirements peaked at 49 beds per 100 000 on April 1-2 weeks after the start of a national lockdown.,"['halves SARS-CoV-2 infections among the elderly, we randomly excluded 50% of patients aged 65 years and older', '2432 COVID-19 patients hospitalized in a large hospital in Madrid, Spain, between February 28 and April 23, 2020, we estimated the number of critical care beds needed to admit all critical care patients']",[],[],"[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}]",[],[],,0.0807887,Critical care requirements peaked at 49 beds per 100 000 on April 1-2 weeks after the start of a national lockdown.,"[{'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Martínez-Alés', 'Affiliation': 'Gonzalo Martínez-Alés is with the Department of Epidemiology, Columbia University Mailman School of Public Health, New York, NY. Arce Domingo-Relloso is with the National Center of Epidemiology, Carlos III Health Institute, Madrid, Spain, and the Department of Environmental Health Sciences, Columbia University Mailman School of Public Health. José R. Arribas and Manuel Quintana-Díaz are with the Instituto de Investigación Hospital Universitario, La Paz University Hospital, Madrid, Spain. Manuel Quintana-Díaz is also with the Universidad Autónoma de Madrid School of Medicine, Madrid, Spain. Miguel A. Hernán is with the Departments of Epidemiology and Biostatics, Harvard T.H. Chan School of Public Health, Harvard-MIT Division of Health Sciences and Technology, Boston, MA.'}, {'ForeName': 'Arce', 'Initials': 'A', 'LastName': 'Domingo-Relloso', 'Affiliation': 'Gonzalo Martínez-Alés is with the Department of Epidemiology, Columbia University Mailman School of Public Health, New York, NY. Arce Domingo-Relloso is with the National Center of Epidemiology, Carlos III Health Institute, Madrid, Spain, and the Department of Environmental Health Sciences, Columbia University Mailman School of Public Health. José R. Arribas and Manuel Quintana-Díaz are with the Instituto de Investigación Hospital Universitario, La Paz University Hospital, Madrid, Spain. Manuel Quintana-Díaz is also with the Universidad Autónoma de Madrid School of Medicine, Madrid, Spain. Miguel A. Hernán is with the Departments of Epidemiology and Biostatics, Harvard T.H. Chan School of Public Health, Harvard-MIT Division of Health Sciences and Technology, Boston, MA.'}, {'ForeName': 'José R', 'Initials': 'JR', 'LastName': 'Arribas', 'Affiliation': 'Gonzalo Martínez-Alés is with the Department of Epidemiology, Columbia University Mailman School of Public Health, New York, NY. Arce Domingo-Relloso is with the National Center of Epidemiology, Carlos III Health Institute, Madrid, Spain, and the Department of Environmental Health Sciences, Columbia University Mailman School of Public Health. José R. Arribas and Manuel Quintana-Díaz are with the Instituto de Investigación Hospital Universitario, La Paz University Hospital, Madrid, Spain. Manuel Quintana-Díaz is also with the Universidad Autónoma de Madrid School of Medicine, Madrid, Spain. Miguel A. Hernán is with the Departments of Epidemiology and Biostatics, Harvard T.H. Chan School of Public Health, Harvard-MIT Division of Health Sciences and Technology, Boston, MA.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Quintana-Díaz', 'Affiliation': 'Gonzalo Martínez-Alés is with the Department of Epidemiology, Columbia University Mailman School of Public Health, New York, NY. Arce Domingo-Relloso is with the National Center of Epidemiology, Carlos III Health Institute, Madrid, Spain, and the Department of Environmental Health Sciences, Columbia University Mailman School of Public Health. José R. Arribas and Manuel Quintana-Díaz are with the Instituto de Investigación Hospital Universitario, La Paz University Hospital, Madrid, Spain. Manuel Quintana-Díaz is also with the Universidad Autónoma de Madrid School of Medicine, Madrid, Spain. Miguel A. Hernán is with the Departments of Epidemiology and Biostatics, Harvard T.H. Chan School of Public Health, Harvard-MIT Division of Health Sciences and Technology, Boston, MA.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Hernán', 'Affiliation': 'Gonzalo Martínez-Alés is with the Department of Epidemiology, Columbia University Mailman School of Public Health, New York, NY. Arce Domingo-Relloso is with the National Center of Epidemiology, Carlos III Health Institute, Madrid, Spain, and the Department of Environmental Health Sciences, Columbia University Mailman School of Public Health. José R. Arribas and Manuel Quintana-Díaz are with the Instituto de Investigación Hospital Universitario, La Paz University Hospital, Madrid, Spain. Manuel Quintana-Díaz is also with the Universidad Autónoma de Madrid School of Medicine, Madrid, Spain. Miguel A. Hernán is with the Departments of Epidemiology and Biostatics, Harvard T.H. Chan School of Public Health, Harvard-MIT Division of Health Sciences and Technology, Boston, MA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Gonzalo Martínez-Alés is with the Department of Epidemiology, Columbia University Mailman School of Public Health, New York, NY. Arce Domingo-Relloso is with the National Center of Epidemiology, Carlos III Health Institute, Madrid, Spain, and the Department of Environmental Health Sciences, Columbia University Mailman School of Public Health. José R. Arribas and Manuel Quintana-Díaz are with the Instituto de Investigación Hospital Universitario, La Paz University Hospital, Madrid, Spain. Manuel Quintana-Díaz is also with the Universidad Autónoma de Madrid School of Medicine, Madrid, Spain. Miguel A. Hernán is with the Departments of Epidemiology and Biostatics, Harvard T.H. Chan School of Public Health, Harvard-MIT Division of Health Sciences and Technology, Boston, MA.'}]",American journal of public health,['10.2105/AJPH.2020.306151'] 2558,33740415,"Aggressive fluid hydration plus non-steroidal anti-inflammatory drugs versus non-steroidal anti-inflammatory drugs alone for post-endoscopic retrograde cholangiopancreatography pancreatitis (FLUYT): a multicentre, open-label, randomised, controlled trial.","BACKGROUND Pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). Prophylactic rectal administration of non-steroidal anti-inflammatory drugs (NSAIDs) is considered as standard of care to reduce the risk of post-ERCP pancreatitis. It has been suggested that aggressive hydration might further reduce this risk. Guidelines already recommend aggressive hydration in patients who are unable to receive rectal NSAIDs, although it is laborious and time consuming. We aimed to evaluate the added value of aggressive hydration in patients receiving prophylactic rectal NSAIDs. METHODS FLUYT, a multicentre, open-label, randomised, controlled trial done across 22 Dutch hospitals, included patients aged between 18 and 85 years with moderate to high risk of post-ERCP pancreatitis. Patients were randomly assigned (1:1) by a web-based module with varying block sizes to a combination of aggressive hydration and rectal NSAIDs (100 mg diclofenac or indomethacin; aggressive hydration group) or rectal NSAIDs (100 mg diclofenac or indomethacin) alone (control group). Randomisation was stratified according to treatment centre. Aggressive hydration comprised 20 mL/kg intravenous Ringer's lactate solution within 60 min from the start of ERCP, followed by 3 mL/kg per h for 8 h. The control group received normal intravenous saline with a maximum of 1·5 mL/kg per h and 3 L per 24 h. The primary endpoint was post-ERCP pancreatitis and was analysed on a modified intention-to-treat basis (including all patients who underwent randomisation and an ERCP and for whom data regarding the primary outcome were available). The trial is registered with the ISRCTN registry, ISRCTN13659155. FINDINGS Between June 5, 2015, and June 6, 2019, 826 patients were randomly assigned, of whom 388 in the aggressive hydration group and 425 in the control group were included in the modified intention-to-treat analysis. Post-ERCP pancreatitis occurred in 30 (8%) patients in the aggressive hydration group and in 39 (9%) patients in the control group (relative risk 0·84, 95% CI 0·53-1·33, p=0·53). There were no differences in serious adverse events, including hydration-related complications (relative risk 0·99, 95% CI 0·59-1·64; p=1·00), ERCP-related complications (0·90, 0·62-1·31; p=0·62), intensive care unit admission (0·37, 0·07-1·80; p=0·22), and 30-day mortality (0·95, 0·50-1·83; p=1·00). INTERPRETATION Aggressive periprocedural hydration did not reduce the incidence of post-ERCP pancreatitis in patients with moderate to high risk of developing this complication who routinely received prophylactic rectal NSAIDs. Therefore, the burden of laborious and time-consuming aggressive periprocedural hydration to further reduce the risk of post-ERCP pancreatitis is not justified. FUNDING Netherlands Organisation for Health Research and Development and Radboud University Medical Center.",2021,"There were no differences in serious adverse events, including hydration-related complications (relative risk 0·99, 95% CI 0·59-1·64; p=1·00), ERCP-related complications (0·90, 0·62-1·31; p=0·62), intensive care unit admission (0·37, 0·07-1·80; p=0·22), and 30-day mortality (0·95, 0·50-1·83; p=1·00). ","['post-endoscopic retrograde cholangiopancreatography pancreatitis (FLUYT', 'Between June 5, 2015, and June 6, 2019', 'patients receiving prophylactic rectal NSAIDs', '826 patients were randomly assigned, of whom 388 in the aggressive hydration group and 425 in the control group were included in the modified intention-to-treat analysis', '22 Dutch hospitals, included patients aged between 18 and 85 years with moderate to high risk of post-ERCP pancreatitis']","['normal intravenous saline', 'Aggressive fluid hydration plus non-steroidal anti-inflammatory drugs versus non-steroidal anti-inflammatory drugs alone', 'prophylactic rectal NSAIDs', 'endoscopic retrograde cholangiopancreatography (ERCP', 'aggressive hydration and rectal NSAIDs (100 mg diclofenac or indomethacin; aggressive hydration group) or rectal NSAIDs (100 mg diclofenac or indomethacin) alone (control group', 'Prophylactic rectal administration of non-steroidal anti-inflammatory drugs (NSAIDs', ""Aggressive hydration comprised 20 mL/kg intravenous Ringer's lactate solution""]","['Post-ERCP pancreatitis', 'serious adverse events, including hydration-related complications', '30-day mortality', 'post-ERCP pancreatitis']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3844105', 'cui_str': '425'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1527425', 'cui_str': 'Rectal route'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0073385', 'cui_str': ""Lactated Ringer's Solution""}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",826.0,0.319,"There were no differences in serious adverse events, including hydration-related complications (relative risk 0·99, 95% CI 0·59-1·64; p=1·00), ERCP-related complications (0·90, 0·62-1·31; p=0·62), intensive care unit admission (0·37, 0·07-1·80; p=0·22), and 30-day mortality (0·95, 0·50-1·83; p=1·00). ","[{'ForeName': 'Christina J', 'Initials': 'CJ', 'LastName': 'Sperna Weiland', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, Netherlands; Department of Research and Development, St Antonius Hospital, Nieuwegein, Netherlands.'}, {'ForeName': 'Xavier J N M', 'Initials': 'XJNM', 'LastName': 'Smeets', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, Netherlands; Department of Research and Development, St Antonius Hospital, Nieuwegein, Netherlands.'}, {'ForeName': 'Wietske', 'Initials': 'W', 'LastName': 'Kievit', 'Affiliation': 'Department for Health Evidence, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Verdonk', 'Affiliation': 'Department of Gastroenterology and Hepatology, St Antonius Hospital, Nieuwegein, Netherlands.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Poen', 'Affiliation': 'Department of Gastroenterology and Hepatology, Isala Clinics, Zwolle, Netherlands.'}, {'ForeName': 'Abha', 'Initials': 'A', 'LastName': 'Bhalla', 'Affiliation': 'Department of Gastroenterology and Hepatology, Hagaziekenhuis, The Hague, Netherlands.'}, {'ForeName': 'Niels G', 'Initials': 'NG', 'LastName': 'Venneman', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medisch Spectrum Twente, Enschede, Netherlands.'}, {'ForeName': 'Ben J M', 'Initials': 'BJM', 'LastName': 'Witteman', 'Affiliation': 'Department of Gastroenterology and Hepatology, Gelderse Vallei Hospital, Ede, Netherlands.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'da Costa', 'Affiliation': 'Department of Radiology, St Antonius Hospital, Nieuwegein, Netherlands.'}, {'ForeName': 'Brechje C', 'Initials': 'BC', 'LastName': 'van Eijck', 'Affiliation': 'Department of Gastroenterology and Hepatology, Spaarne Gasthuis, Hoofddorp, Netherlands.'}, {'ForeName': 'Matthijs P', 'Initials': 'MP', 'LastName': 'Schwartz', 'Affiliation': 'Department of Gastroenterology and Hepatology, Meander Medical Centre, Amersfoort, Netherlands.'}, {'ForeName': 'Tessa E H', 'Initials': 'TEH', 'LastName': 'Römkens', 'Affiliation': 'Department of Gastroenterology and Hepatology, Jeroen Bosch Hospital, Den Bosch, Netherlands.'}, {'ForeName': 'Jan Maarten', 'Initials': 'JM', 'LastName': 'Vrolijk', 'Affiliation': 'Department of Gastroenterology and Hepatology, Rijnstate Hospital, Arnhem, Netherlands.'}, {'ForeName': 'Muhammed', 'Initials': 'M', 'LastName': 'Hadithi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Maasstad Hospital, Rotterdam, Netherlands.'}, {'ForeName': 'Annet M C J', 'Initials': 'AMCJ', 'LastName': 'Voorburg', 'Affiliation': 'Department of Gastroenterology and Hepatology, Diakonessenhuis, Utrecht, Netherlands.'}, {'ForeName': 'Lubbertus C', 'Initials': 'LC', 'LastName': 'Baak', 'Affiliation': 'Department of Gastroenterology and Hepatology, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands.'}, {'ForeName': 'Willem J', 'Initials': 'WJ', 'LastName': 'Thijs', 'Affiliation': 'Department of Gastroenterology and Hepatology, Martini Hospital, Groningen, Netherlands.'}, {'ForeName': 'Roy L', 'Initials': 'RL', 'LastName': 'van Wanrooij', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Adriaan C I T L', 'Initials': 'ACITL', 'LastName': 'Tan', 'Affiliation': 'Department of Gastroenterology and Hepatology, Canisius Wilhelmina Hospital, Nijmegen, Netherlands.'}, {'ForeName': 'Tom C J', 'Initials': 'TCJ', 'LastName': 'Seerden', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amphia Hospital, Breda, Netherlands.'}, {'ForeName': 'Yolande C A', 'Initials': 'YCA', 'LastName': 'Keulemans', 'Affiliation': 'Department of Gastroenterology and Hepatology, Zuyderland Hospital, Heerlen, Netherlands.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'de Wijkerslooth', 'Affiliation': 'Department of Gastroenterology and Hepatology, Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'van de Vrie', 'Affiliation': 'Department of Gastroenterology and Hepatology, Albert Schweitzer Hospital, Dordrecht, Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'van der Schaar', 'Affiliation': 'Department of Gastroenterology and Hepatology, St Antonius Hospital, Nieuwegein, Netherlands.'}, {'ForeName': 'Sven M', 'Initials': 'SM', 'LastName': 'van Dijk', 'Affiliation': 'Department of Research and Development, St Antonius Hospital, Nieuwegein, Netherlands; Department of Surgery, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Nora D L', 'Initials': 'NDL', 'LastName': 'Hallensleben', 'Affiliation': 'Department of Research and Development, St Antonius Hospital, Nieuwegein, Netherlands; Department of Anaesthesiology, Erasmus Medical Centre, Rotterdam, Netherlands.'}, {'ForeName': 'Ruud L', 'Initials': 'RL', 'LastName': 'Sperna Weiland', 'Affiliation': 'Institute for Environmental Studies, Vrije Universiteit, Amsterdam, Netherlands.'}, {'ForeName': 'Hester C', 'Initials': 'HC', 'LastName': 'Timmerhuis', 'Affiliation': 'Department of Research and Development, St Antonius Hospital, Nieuwegein, Netherlands.'}, {'ForeName': 'Devica S', 'Initials': 'DS', 'LastName': 'Umans', 'Affiliation': 'Department of Research and Development, St Antonius Hospital, Nieuwegein, Netherlands; Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Jeanin E', 'Initials': 'JE', 'LastName': 'van Hooft', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands; Department of Gastroenterology and Hepatology, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'van Goor', 'Affiliation': 'Department of Surgery, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Hjalmar C', 'Initials': 'HC', 'LastName': 'van Santvoort', 'Affiliation': 'Department of Surgery, St Antonius Hospital, Nieuwegein, Netherlands; Department of Surgery, University Medical Centre Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Marc G', 'Initials': 'MG', 'LastName': 'Besselink', 'Affiliation': 'Department of Surgery, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Marco J', 'Initials': 'MJ', 'LastName': 'Bruno', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus Medical Centre, Rotterdam, Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Fockens', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Joost P H', 'Initials': 'JPH', 'LastName': 'Drenth', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Erwin J M', 'Initials': 'EJM', 'LastName': 'van Geenen', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, Netherlands. Electronic address: erwin.vangeenen@radboudumc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(21)00057-1'] 2559,33740816,Posterior Quadratus Lumborum Block in Total Hip Arthroplasty: A Randomized Controlled Trial.,"BACKGROUND Pain management is important for ensuring early mobilization after hip arthroplasty; however, the optimal components remain controversial. Recently, the quadratus lumborum block has been proposed as an analgesic option. The current study tested the hypothesis that the posterior quadratus lumborum block combined with multimodal analgesia decreases morphine consumption after hip arthroplasty. METHODS This study was a prospective, randomized, double-blind, placebo-controlled trial. Before general anesthesia, 100 participating patients scheduled for elective total hip arthroplasty were randomly allocated to receive a 30-ml injection posterior to the quadratus lumborum muscle with either 0.33% ropivacaine (n = 50) or normal saline (n = 50). For all patients, multimodal analgesia included systematic administration of acetaminophen, ketoprofen, and a morphine intravenous patient-controlled analgesia. The primary outcome was total intravenous morphine consumption in the first 24 h. Secondary outcomes recorded intraoperative sufentanil consumption; morphine consumption in the postanesthesia care unit; pain scores at extubation and at 2, 6, 12, and 24 h; motor blockade; time to first standing and ambulation; hospital length of stay; and adverse events. RESULTS There was no significant difference in the 24-h total morphine consumption (ropivacaine group, median [interquartile range], 13 [7 to 21] versus saline group, 16 [9 to 21] mg; median difference, -1.5; 95% CI, -5 to 2; P = 0.337). Pain scores were not different between the groups (β = -0.4; 95% CI, -0.9 to 0.2; P = 0.199). There was no statistical difference between the two groups in intraoperative sufentanil consumption, morphine consumption in the postanesthesia care unit, motor blockade, times to first standing (median difference, 0.83 h; 95% CI, -1.7 to 3.4; P = 0.690) and ambulation (median difference, -1.85 h; 95% CI, -4.5 to 0.8; P = 0.173), hospital length of stay, and adverse events. CONCLUSIONS After elective hip arthroplasty, neither morphine consumption nor pain scores were reduced by the addition of a posterior quadratus lumborum block to a multimodal analgesia regimen. EDITOR’S PERSPECTIVE ",2021,"There was no statistical difference between the two groups in intraoperative sufentanil consumption, morphine consumption in the postanesthesia care unit, motor blockade, times to first standing (median difference, 0.83 h; 95% CI, -1.7 to 3.4; P = 0.690) and ambulation (median difference, -1.85 h; 95% CI, -4.5 to 0.8; P = 0.173), hospital length of stay, and adverse events. ","['100 participating patients scheduled for elective total hip arthroplasty', 'after hip arthroplasty', 'Total Hip Arthroplasty']","['Posterior Quadratus Lumborum Block', 'posterior quadratus lumborum block combined with multimodal analgesia', 'placebo', 'morphine intravenous patient-controlled analgesia', '30-ml injection posterior to the quadratus lumborum muscle with either 0.33% ropivacaine', 'acetaminophen, ketoprofen', 'normal saline']","['morphine consumption nor pain scores', 'intraoperative sufentanil consumption; morphine consumption in the postanesthesia care unit; pain scores at extubation and at 2, 6, 12, and 24 h; motor blockade; time to first standing and ambulation; hospital length of stay; and adverse events', 'Pain scores', 'ambulation', 'hospital length of stay, and adverse events', '24-h total morphine consumption', 'total intravenous morphine consumption', 'intraoperative sufentanil consumption, morphine consumption in the postanesthesia care unit, motor blockade, times to first standing', 'morphine consumption']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0186193', 'cui_str': 'Repair of hip'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C4517449', 'cui_str': '0.33'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0022635', 'cui_str': 'Ketoprofen'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]",100.0,0.692383,"There was no statistical difference between the two groups in intraoperative sufentanil consumption, morphine consumption in the postanesthesia care unit, motor blockade, times to first standing (median difference, 0.83 h; 95% CI, -1.7 to 3.4; P = 0.690) and ambulation (median difference, -1.85 h; 95% CI, -4.5 to 0.8; P = 0.173), hospital length of stay, and adverse events. ","[{'ForeName': 'Sophia Margareta', 'Initials': 'SM', 'LastName': 'Brixel', 'Affiliation': ''}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Biboulet', 'Affiliation': ''}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Swisser', 'Affiliation': ''}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Choquet', 'Affiliation': ''}, {'ForeName': 'Yassir', 'Initials': 'Y', 'LastName': 'Aarab', 'Affiliation': ''}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Nguyen', 'Affiliation': ''}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Bringuier', 'Affiliation': ''}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Capdevila', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003745'] 2560,33740113,Clinical benefit of glasdegib plus low-dose cytarabine in patients with de novo and secondary acute myeloid leukemia: long-term analysis of a phase II randomized trial.,"This analysis from the phase II BRIGHT AML 1003 trial reports the long-term efficacy and safety of glasdegib + low-dose cytarabine (LDAC) in patients with acute myeloid leukemia ineligible for intensive chemotherapy. The multicenter, open-label study randomized (2:1) patients to receive glasdegib + LDAC (de novo, n = 38; secondary acute myeloid leukemia, n = 40) or LDAC alone (de novo, n = 18; secondary acute myeloid leukemia, n = 20). At the time of analysis, 90% of patients had died, with the longest follow-up since randomization 36 months. The combination of glasdegib and LDAC conferred superior overall survival (OS) versus LDAC alone; hazard ratio (HR) 0.495; (95% confidence interval [CI] 0.325-0.752); p = 0.0004; median OS was 8.3 versus 4.3 months. Improvement in OS was consistent across cytogenetic risk groups. In a post-hoc subgroup analysis, a survival trend with glasdegib + LDAC was observed in patients with de novo acute myeloid leukemia (HR 0.720; 95% CI 0.395-1.312; p = 0.14; median OS 6.6 vs 4.3 months) and secondary acute myeloid leukemia (HR 0.287; 95% CI 0.151-0.548; p < 0.0001; median OS 9.1 vs 4.1 months). The incidence of adverse events in the glasdegib + LDAC arm decreased after 90 days' therapy: 83.7% versus 98.7% during the first 90 days. Glasdegib + LDAC versus LDAC alone continued to demonstrate superior OS in patients with acute myeloid leukemia; the clinical benefit with glasdegib + LDAC was particularly prominent in patients with secondary acute myeloid leukemia. ClinicalTrials.gov identifier: NCT01546038.",2021,The combination of glasdegib and LDAC conferred superior overall survival (OS) versus LDAC alone; hazard ratio (HR) 0.495; (95% confidence interval [CI] 0.325-0.752); p = 0.0004; median OS was 8.3 versus 4.3 months.,"['patients with de novo and secondary acute myeloid leukemia', 'patients with acute myeloid leukemia ineligible for intensive chemotherapy', 'patients with secondary acute myeloid leukemia', 'de novo, n = 38; secondary acute myeloid leukemia, n = 40) or LDAC alone (de novo, n = 18; secondary acute myeloid leukemia, n = 20', 'patients with acute myeloid leukemia']","['glasdegib + low-dose cytarabine (LDAC', 'glasdegib and LDAC', 'Glasdegib + LDAC versus LDAC', 'glasdegib plus low-dose cytarabine', 'glasdegib + LDAC']","['secondary acute myeloid leukemia', 'superior overall survival (OS', 'incidence of adverse events', 'survival trend with glasdegib + LDAC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C4519273', 'cui_str': 'glasdegib'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040833', 'cui_str': 'trends'}, {'cui': 'C4519273', 'cui_str': 'glasdegib'}]",,0.123747,The combination of glasdegib and LDAC conferred superior overall survival (OS) versus LDAC alone; hazard ratio (HR) 0.495; (95% confidence interval [CI] 0.325-0.752); p = 0.0004; median OS was 8.3 versus 4.3 months.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Heuser', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany. Heuser.Michael@mh-hannover.de.'}, {'ForeName': 'B Douglas', 'Initials': 'BD', 'LastName': 'Smith', 'Affiliation': 'Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Fiedler', 'Affiliation': 'Department of Hematology and Oncology, University Hospital Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Mikkael A', 'Initials': 'MA', 'LastName': 'Sekeres', 'Affiliation': 'Division of Hematology, Sylvester Comprehensive Cancer Center, University of Miami, FL, Miami, USA.'}, {'ForeName': 'Pau', 'Initials': 'P', 'LastName': 'Montesinos', 'Affiliation': 'Hospital Universitari i Politècnic La Fe, Valencia, Spain.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Leber', 'Affiliation': 'Juravinski Hospital at Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Akil', 'Initials': 'A', 'LastName': 'Merchant', 'Affiliation': 'Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Papayannidis', 'Affiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Pérez-Simón', 'Affiliation': 'Hospital Universitario Virgen del Rocío, Instituto de Biomedicina (IbiS)/CSIC/CIBERONC), Universidad de Sevilla, Seville, Spain.'}, {'ForeName': 'Caroline J', 'Initials': 'CJ', 'LastName': 'Hoang', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': ""O'Brien"", 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Weidong Wendy', 'Initials': 'WW', 'LastName': 'Ma', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Mirjana', 'Initials': 'M', 'LastName': 'Zeremski', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Ashleigh', 'Initials': 'A', 'LastName': ""O'Connell"", 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Chan', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Cortes', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",Annals of hematology,['10.1007/s00277-021-04465-4'] 2561,33739852,Favorable Trisomies and ETV6-RUNX1 Predict Cure in Low-Risk B-Cell Acute Lymphoblastic Leukemia: Results From Children's Oncology Group Trial AALL0331.,"PURPOSE Children's Oncology Group (COG) AALL0331 tested whether pegaspargase intensification on a low-intensity chemotherapy backbone would improve the continuous complete remission (CCR) rate in a low-risk subset of children with standard-risk B-acute lymphoblastic leukemia (ALL). METHODS AALL0331 enrolled 5,377 patients with National Cancer Institute standard-risk B-ALL (age 1-9 years, WBC < 50,000/μL) between 2005 and 2010. Following a common three-drug induction, a cohort of 1,857 eligible patients participated in the low-risk ALL random assignment. Low-risk criteria included no extramedullary disease, < 5% marrow blasts by day 15, end-induction marrow minimal residual disease < 0.1%, and favorable cytogenetics ( ETV6-RUNX1 fusion or simultaneous trisomies of chromosomes 4, 10, and 17). Random assignment was to standard COG low-intensity therapy (including two pegaspargase doses, one each during induction and delayed intensification) with or without four additional pegaspargase doses at 3-week intervals during consolidation and interim maintenance. The study was powered to detect a 4% improvement in 6-year CCR rate from 92% to 96%. RESULTS The 6-year CCR and overall survival (OS) rates for the entire low-risk cohort were 94.7% ± 0.6% and 98.7% ± 0.3%, respectively. The CCR rates were similar between arms (intensified pegaspargase 95.3% ± 0.8% v standard 94.0% ± 0.8%; P = .13) with no difference in OS (98.1% ± 0.5% v 99.2% ± 0.3%; P = .99). Compared to a subset of standard-risk study patients given identical therapy who had the same early response characteristics but did not have favorable or unfavorable cytogenetics, outcomes were significantly superior for low-risk patients (CCR hazard ratio 1.95; P = .0004; OS hazard ratio 5.42; P < .0001). CONCLUSION Standard COG therapy without intensified pegaspargase, which can easily be given as an outpatient with limited toxicity, cures nearly all children with B-ALL identified as low-risk by clinical, early response, and favorable cytogenetic criteria.",2021,The CCR rates were similar between arms (intensified pegaspargase 95.3% ± 0.8% v standard 94.0% ± 0.8%; P = .13) with no difference in OS (98.1% ± 0.5% v 99.2% ± 0.3%; P = .99).,"[""Children's Oncology Group (COG"", 'Low-Risk B-Cell Acute Lymphoblastic Leukemia', '1,857 eligible patients participated in the low-risk ALL random assignment', 'AALL0331 enrolled 5,377 patients with National Cancer Institute standard-risk B-ALL (age 1-9 years, WBC']","['ETV6-RUNX1', 'standard COG low-intensity therapy']","['6-year CCR rate', 'CCR rates', 'continuous complete remission (CCR) rate', '6-year CCR and overall survival']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C1292769', 'cui_str': 'Precursor B-cell lymphoblastic leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0349636', 'cui_str': 'Pre B-cell acute lymphoblastic leukemia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}]","[{'cui': 'C1568122', 'cui_str': 'ETV6 protein, human'}, {'cui': 'C1435548', 'cui_str': 'RUNX1 protein, human'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",5377.0,0.082472,The CCR rates were similar between arms (intensified pegaspargase 95.3% ± 0.8% v standard 94.0% ± 0.8%; P = .13) with no difference in OS (98.1% ± 0.5% v 99.2% ± 0.3%; P = .99).,"[{'ForeName': 'Leonard A', 'Initials': 'LA', 'LastName': 'Mattano', 'Affiliation': 'HARP Pharma Consulting, Mystic, CT.'}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Devidas', 'Affiliation': ""Department of Global Pediatric Medicine, St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Kelly W', 'Initials': 'KW', 'LastName': 'Maloney', 'Affiliation': ""Department of Pediatrics, University of Colorado and Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Colleges of Medicine, Public Health, and Health Professions, University of Florida, Gainesville, FL.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Friedmann', 'Affiliation': 'Department of Pediatrics, Massachusetts General Hospital Cancer Center, Boston, MA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Buckley', 'Affiliation': 'Department of Pathology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Borowitz', 'Affiliation': 'Department of Pathology, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Carroll', 'Affiliation': ""Department of Genetics, Children's Hospital of Alabama, Birmingham, AL.""}, {'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Gastier-Foster', 'Affiliation': ""Department of Pathology and Laboratory Medicine, Nationwide Children's Hospital, Ohio State University College of Medicine, Columbus, OH.""}, {'ForeName': 'Nyla A', 'Initials': 'NA', 'LastName': 'Heerema', 'Affiliation': 'Department of Pathology, Wexner Medical Center, Ohio State University, Columbus, OH.'}, {'ForeName': 'Nina S', 'Initials': 'NS', 'LastName': 'Kadan-Lottick', 'Affiliation': 'Department of Pediatrics, Yale University and Yale Cancer Center, New Haven, CT.'}, {'ForeName': 'Yousif H', 'Initials': 'YH', 'LastName': 'Matloub', 'Affiliation': 'Case Western Reserve University School of Medicine, Cleveland, OH.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Marshall', 'Affiliation': 'Department of Radiation Oncology, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Linda C', 'Initials': 'LC', 'LastName': 'Stork', 'Affiliation': 'Department of Pediatrics, Oregon Health and Science University, Portland, OR.'}, {'ForeName': 'Mignon L', 'Initials': 'ML', 'LastName': 'Loh', 'Affiliation': ""Department of Pediatrics, Benioff Children's Hospital and the Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA.""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Raetz', 'Affiliation': 'Perlmutter Cancer Center and Department of Pediatrics, NYU Langone Medical Center, New York, NY.'}, {'ForeName': 'Brent L', 'Initials': 'BL', 'LastName': 'Wood', 'Affiliation': 'Departments of Pathology and Medicine, University of Washington, Seattle, WA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Hunger', 'Affiliation': ""Department of Pediatrics and The Center for Childhood Cancer Research, Children's Hospital of Philadelphia and the Perelman School of Medicine at The University of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Carroll', 'Affiliation': 'Perlmutter Cancer Center and Department of Pediatrics, NYU Langone Medical Center, New York, NY.'}, {'ForeName': 'Naomi J', 'Initials': 'NJ', 'LastName': 'Winick', 'Affiliation': 'Department of Pediatrics, UT Southwestern, Simmons Cancer Center, Dallas, TX.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.02370'] 2562,33743292,Medical high-protein nutrition therapy and loss of muscle mass in adult ICU patients: A randomized controlled trial.,"BACKGROUND & AIMS The degradation of muscle mass and loss of functional proteins due to catabolism are associated with adverse outcomes in critically ill patients. While an adequate supply of protein within a medical nutrition concept is suggested to minimize proteolysis, the specificities on appropriate dosage and timing are still under debate. The current study aimed to evaluate the effect of two different quantities of protein as part of a standardized energetically controlled nutrition therapy for the preservation of muscle mass in the later phase of critical illness. METHODS A randomized controlled trial was conducted in 42 critically ill patients (age 65 ± 15; 12 females; SAPS 45 ± 11; TISS 20 ± 7; SOFA-score 7 ± 3). The subjects were randomly assigned to either the intervention (1.8 g protein/kg body weight [BW]/d) or standard (1.2 g protein/kg BW/d) group. Nutrient supply via enteral and/or parenteral nutrition was calculated based on the individual energy expenditure measured by indirect calorimetry and target protein content. Quadriceps muscle layer thickness (QMLT) was observed through sonography at inclusion, and during the follow-up period, two and four weeks after inclusion. The measurement points were fixed on two sides at the midpoint and two-thirds between the anterior superior iliac spine and top of the patella. The data were analyzed descriptively wherein chi-squared tests or unpaired two-samle t-tests checked group differences. Daily changes in muscle mass were estimated using a linear mixed model. All data are shown as the mean ± standard deviation (SD). RESULTS Actual protein intake reached 1.5 ± 0.5 g and 1.0 ± 0.5 g/kg BW/d in the intervention and standard group, respectively. Mean values of all measurements of QMLT at inclusion (day 13 ± 2 after ICU admission) were 13.5 ± 7.4 mm and 13.4 ± 7.1 mm in the intervention and standard group, respectively (P = 0.967). In both the groups, QMLT decreased over time (P < 0.001), while the estimated mean values of daily QMLT changes were -0.15 ± 0.08 mm (intervention) and -0.28 ± 0.08 mm (standard) without significant between-group differences (intervention effect, P = 0.368; time x intervention effect, P = 0.242). Illness scores and clinical outcomes showed no group differences. CONCLUSION In this single-center trial the increased amounts of protein (1.5 g vs. 1.0 g/kg BW/d) provided through medical nutrition therapy in the late phase of critical illness did not achieve a statistically significant impact on the loss of muscle mass in long-term immobilized ICU patients. Larger multi-center trials are needed to evaluate whether observed numerical differences in muscle mass could be a true finding, and will translate into improved clinical outcomes. TRIAL REGISTRATION German Clinical Trials Register (http://www.drks.de/), DRKS-ID: DRKS00013594.",2021,"In both the groups, QMLT decreased over time (P < 0.001), while the estimated mean values of daily QMLT changes were -0.15 ","['adult ICU patients', '42 critically ill patients (age 65\xa0±\xa015; 12 females; SAPS 45\xa0±\xa011; TISS 20\xa0±\xa07; SOFA-score 7\xa0±\xa03', 'critically ill patients']","['QMLT', 'medical nutrition therapy', 'Medical high-protein nutrition therapy']","['mean values of daily QMLT changes', 'loss of muscle mass', 'Illness scores and clinical outcomes', 'Quadriceps muscle layer thickness (QMLT']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1740186', 'cui_str': 'SKAP2 protein, human'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0225358', 'cui_str': 'Muscularis propria'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1257928', 'cui_str': 'Medical Nutrition Therapy'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0225358', 'cui_str': 'Muscularis propria'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",42.0,0.0942149,"In both the groups, QMLT decreased over time (P < 0.001), while the estimated mean values of daily QMLT changes were -0.15 ","[{'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Dresen', 'Affiliation': 'Department of Nutrition and Food Sciences, Nutritional Physiology, University of Bonn, Nußallee 9, 53115, Bonn, Germany. Electronic address: e.dresen@uni-bonn.de.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Weißbrich', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital of Bonn, Venusberg-Campus 1, 53127, Bonn, Germany. Electronic address: carsten.weissbrich@ukbonn.de.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Fimmers', 'Affiliation': 'Institute of Medical Biometry, Information Technology and Epidemiology, University of Bonn, Venusberg-Campus 1, 53127, Bonn, Germany. Electronic address: fimmers@imbie.meb.uni-bonn.de.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Putensen', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital of Bonn, Venusberg-Campus 1, 53127, Bonn, Germany. Electronic address: christian.putensen@ukbonn.de.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Stehle', 'Affiliation': 'Department of Nutrition and Food Sciences, Nutritional Physiology, University of Bonn, Nußallee 9, 53115, Bonn, Germany. Electronic address: pstehle@uni-bonn.de.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2021.02.021'] 2563,33743390,Binary dance rhythm or Quaternary dance rhythm which has the greatest effect on non-motor symptoms of individuals with Parkinson's disease?,"This study aimed to compare the effect of a binary and quaternary rhythm protocol on cognition, mental activity, daily life, and quality of life among individuals with Parkinson's Disease. A two-arm randomized clinical trial with 31 individuals diagnosed with Parkinson's disease, who were allocated to the binary group or quaternary group. Both groups underwent a 12-week intervention. The following variables were analyzed: personal and clinical information; MoCA; UPDRSI and II; PDQ-39. Both intervention groups improved cognition, mental activity, activities of daily living, and quality of life. In addition, there were intergroup differences in total UPDRSII, writing, and hygiene where the quaternary group was superior to the binary group. It concludes that the binary and quaternary rhythm positively influenced and presented similar effects on the complementary treatment of individuals with Parkinson's disease on the studied variables. Thus, it is believed that both interventions are possible and feasible for the health professionals involved in the area.",2021,"Both intervention groups improved cognition, mental activity, activities of daily living, and quality of life.","[""individuals with Parkinson's Disease"", ""31 individuals diagnosed with Parkinson's disease, who were allocated to the binary group or quaternary group"", ""individuals with Parkinson's disease""]",['binary and quaternary rhythm protocol'],"['cognition, mental activity, activities of daily living, and quality of life', 'cognition, mental activity, daily life, and quality of life', 'total UPDRSII, writing, and hygiene']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}]",31.0,0.0644119,"Both intervention groups improved cognition, mental activity, activities of daily living, and quality of life.","[{'ForeName': 'Jéssica', 'Initials': 'J', 'LastName': 'Moratelli', 'Affiliation': ""PhD Student in Sciences of Human Movement of the Center of Sciences of the Health and of the Sport of the State University of Santa Catarina, Brazil; Brazilian Parkinson's Disease Rehabilitation Initiative - BpaRkI, Brazil.""}, {'ForeName': 'Kettlyn Hames', 'Initials': 'KH', 'LastName': 'Alexandre', 'Affiliation': ""Master's Degree Student in Sciences of Human Movement of the Center of Sciences of the Health and of the Sport of the State University of Santa Catarina, Brazil; Brazilian Parkinson's Disease Rehabilitation Initiative - BpaRkI, Brazil.""}, {'ForeName': 'Leonessa', 'Initials': 'L', 'LastName': 'Boing', 'Affiliation': 'PhD Student in Sciences of Human Movement of the Center of Sciences of the Health and of the Sport of the State University of Santa Catarina, Brazil.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Swarowsky', 'Affiliation': ""Professor of the Department of Physiotherapy and Post-Graduation Program in Physiotherapy at the Health and Sports Sciences Center of the State University of Santa Catarina, Brazil; Brazilian Parkinson's Disease Rehabilitation Initiative - BpaRkI, Brazil.""}, {'ForeName': 'Clynton Lourenço', 'Initials': 'CL', 'LastName': 'Corrêa', 'Affiliation': ""Professor of the Department of Physiotherapy and Post-Graduation Program in Physical Education of the Federal University of Rio de Janeiro, Brazil; Brazilian Parkinson's Disease Rehabilitation Initiative - BpaRkI, Brazil.""}, {'ForeName': 'Adriana Coutinho de Azevedo', 'Initials': 'ACA', 'LastName': 'Guimarães', 'Affiliation': ""Professor of the Department of Physical Education and Post-Graduation Program in Human Movement Sciences at the Health and Sports Sciences Center of the State University of Santa Catarina, Brazil; Brazilian Parkinson's Disease Rehabilitation Initiative - BpaRkI, Brazil.""}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101348'] 2564,33735740,The Effects of Repetitive Transcranial Magnetic Stimulation in Patients with Chronic Schizophrenia: Insights from EEG Microstates.,"The objective of this study was to investigate the effects of 10 Hz repetitive transcranial magnetic stimulation (rTMS) in patients with schizophrenia using EEG microstates. Thirty-eight patients with chronic schizophrenia were included in a double-blind, randomized and sham-controlled trial (19 participants in the active group and 19 participants in the sham group) and received 10 Hz active or sham rTMS stimulation to the left dorsolateral prefrontal cortex (left DLPFC) 5 days per week over for 4 weeks. Four classical microstate classes (i.e., classes A, B, C and D) were identified by clustering, and the parameters (i.e., duration, occurrence and contribution) of each class were computed. Our results showed that (1) after stimulation, the positive and negative syndrome scale (PANSS) positive scores decreased significantly in the active group; (2) the duration of the microstate of class C derived from EEG data decreased significantly in the active group; and (3) the change of the duration of class D in the active group was significantly higher than that in the sham group. Our findings demonstrated that 10 Hz active rTMS stimulation was beneficial to improving the positive symptoms of patients with chronic schizophrenia, and the EEG microstate could be an effective indicator of symptom improvements.",2021,"Our findings demonstrated that 10 Hz active rTMS stimulation was beneficial to improving the positive symptoms of patients with chronic schizophrenia, and the EEG microstate could be an effective indicator of symptom improvements.","['patients with chronic schizophrenia', 'Thirty-eight patients with chronic schizophrenia', 'patients with schizophrenia using EEG microstates', 'Patients with Chronic Schizophrenia']","['10 Hz active or sham rTMS stimulation to the left dorsolateral prefrontal cortex (left DLPFC', 'Repetitive Transcranial Magnetic Stimulation', '10 Hz repetitive transcranial magnetic stimulation (rTMS']","['EEG data', 'duration of class D', 'positive and negative syndrome scale (PANSS) positive scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221765', 'cui_str': 'Chronic schizophrenia'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0450424', 'cui_str': 'To the left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}]","[{'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",38.0,0.0559854,"Our findings demonstrated that 10 Hz active rTMS stimulation was beneficial to improving the positive symptoms of patients with chronic schizophrenia, and the EEG microstate could be an effective indicator of symptom improvements.","[{'ForeName': 'Zhilin', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': 'Department of Biomedical Engineering, School of Material Science and Engineering, South China University of Technology, Guangzhou 510006, China; Guangdong Engineering Technology Research Center for Translational Medicine of Mental Disorders, Guangzhou 510370, China; National Engineering Research Center for Tissue Restoration and Reconstruction, South China University of Technology, Guangzhou 510006, China.'}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Xiong', 'Affiliation': 'Department of Biomedical Engineering, School of Material Science and Engineering, South China University of Technology, Guangzhou 510006, China; Guangdong Engineering Technology Research Center for Translational Medicine of Mental Disorders, Guangzhou 510370, China; National Engineering Research Center for Tissue Restoration and Reconstruction, South China University of Technology, Guangzhou 510006, China.'}, {'ForeName': 'Huisi', 'Initials': 'H', 'LastName': 'Xiao', 'Affiliation': 'Department of Biomedical Engineering, School of Material Science and Engineering, South China University of Technology, Guangzhou 510006, China; Guangdong Engineering Technology Research Center for Translational Medicine of Mental Disorders, Guangzhou 510370, China; National Engineering Research Center for Tissue Restoration and Reconstruction, South China University of Technology, Guangzhou 510006, China.'}, {'ForeName': 'Jiahui', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Biomedical Engineering, School of Material Science and Engineering, South China University of Technology, Guangzhou 510006, China; Guangdong Engineering Technology Research Center for Translational Medicine of Mental Disorders, Guangzhou 510370, China; National Engineering Research Center for Tissue Restoration and Reconstruction, South China University of Technology, Guangzhou 510006, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'The Affiliated Brain Hospital of Guangzhou Medical University, Guangzhou Huiai Hospital, Guangzhou 510370, China; Guangdong Engineering Technology Research Center for Translational Medicine of Mental Disorders, Guangzhou 510370, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Biomedical Engineering, School of Material Science and Engineering, South China University of Technology, Guangzhou 510006, China; Guangdong Engineering Technology Research Center for Translational Medicine of Mental Disorders, Guangzhou 510370, China; National Engineering Research Center for Tissue Restoration and Reconstruction, South China University of Technology, Guangzhou 510006, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Guangdong Engineering Technology Research Center for Diagnosis and Rehabilitation of Dementia, Guangzhou 510500, China; National Engineering Research Center for Healthcare Devices, Guangzhou 510500, China.'}, {'ForeName': 'Xiaobo', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Biomedical Engineering, New Jersey Institute of Technology, Newark, NJ, U.S.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Ning', 'Affiliation': 'The Affiliated Brain Hospital of Guangzhou Medical University, Guangzhou Huiai Hospital, Guangzhou 510370, China; Guangdong Engineering Technology Research Center for Translational Medicine of Mental Disorders, Guangzhou 510370, China.'}, {'ForeName': 'Fengchun', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'The Affiliated Brain Hospital of Guangzhou Medical University, Guangzhou Huiai Hospital, Guangzhou 510370, China; Guangdong Engineering Technology Research Center for Translational Medicine of Mental Disorders, Guangzhou 510370, China. Electronic address: 13580380071@163.com.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Wu', 'Affiliation': 'Department of Biomedical Engineering, School of Material Science and Engineering, South China University of Technology, Guangzhou 510006, China; The Affiliated Brain Hospital of Guangzhou Medical University, Guangzhou Huiai Hospital, Guangzhou 510370, China; Guangdong Engineering Technology Research Center for Translational Medicine of Mental Disorders, Guangzhou 510370, China; Guangdong Engineering Technology Research Center for Diagnosis and Rehabilitation of Dementia, Guangzhou 510500, China; National Engineering Research Center for Tissue Restoration and Reconstruction, South China University of Technology, Guangzhou 510006, China; Key Laboratory of Biomedical Engineering of Guangdong Province, South China University of Technology, Guangzhou 510006, China; National Engineering Research Center for Healthcare Devices, Guangzhou 510500, China; Department of Nuclear Medicine and Radiology, Institute of Development, Aging and Cancer, Tohoku University, Sendai, Japan 980-8575. Electronic address: kaiwu@scut.edu.cn.'}]",Psychiatry research,['10.1016/j.psychres.2021.113866'] 2565,33824389,Improves symptoms and urinary biomarkers in refractory interstitial cystitis/bladder pain syndrome patients randomized to extracorporeal shock wave therapy versus placebo.,"Extracorporeal shock wave therapy (ESWT) has been shown to improve symptoms in patients with interstitial cystitis/bladder pain syndrome (IC/BPS); however, there is a lack of objective evidence. We measured change of urinary biomarker levels in 25 patients with IC/BPS received ESWT or placebo once a week for 4 weeks. Urines were collected from participants at baseline, 4 and 12 weeks post treatment. A representative 41 inflammatory growth factors, cytokines, and chemokines in urine were measured using a MILLIPLEX immunoassay kit. Symptom bother was assessed by O'Leary-Sant symptom scores (OSS), and visual analog scale (VAS) for pain. The ESWT group exhibited a significant reduction in the OSS and VAS compared to the placebo group 4 weeks post-treatment (P < 0.05), and the effects were persistent at 12 weeks. The difference in urinary markers change in ESWT versus placebo was P = 0.054 for IL4, P = 0.013 for VEGF, and P = 0.039 for IL9 at 4 weeks. The change of urine biomarker was not significant in other biomarkers or all the measured proteins at 12 weeks. The current data suggest that IL4, IL9, and VEGF mediation may be involved in its pathophysiologic mechanisms and response to LESW treatment.",2021,"The ESWT group exhibited a significant reduction in the OSS and VAS compared to the placebo group 4 weeks post-treatment (P < 0.05), and the effects were persistent at 12 weeks.","['refractory interstitial cystitis/bladder pain syndrome patients', '25 patients with IC/BPS received', 'patients with interstitial cystitis/bladder pain syndrome (IC/BPS']","['Extracorporeal shock wave therapy (ESWT', 'placebo', 'ESWT or placebo', 'extracorporeal shock wave therapy versus placebo']","['Symptom bother', 'change of urine biomarker', 'urinary markers change', ""O'Leary-Sant symptom scores (OSS), and visual analog scale (VAS) for pain"", 'OSS and VAS', 'urinary biomarker levels']","[{'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0282488', 'cui_str': 'Ulcerative cystitis'}, {'cui': 'C1720830', 'cui_str': 'Bladder Pain Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",25.0,0.1983,"The ESWT group exhibited a significant reduction in the OSS and VAS compared to the placebo group 4 weeks post-treatment (P < 0.05), and the effects were persistent at 12 weeks.","[{'ForeName': 'Yuan-Chi', 'Initials': 'YC', 'LastName': 'Shen', 'Affiliation': 'Department of Urology, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, 123 Ta Pei Road, Niao Song District, Kaohsiung, Taiwan.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Tyagi', 'Affiliation': 'Department of Urology, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Wei-Chia', 'Initials': 'WC', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, 123 Ta Pei Road, Niao Song District, Kaohsiung, Taiwan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Chancellor', 'Affiliation': 'Department of Urology, Beaumont Health System, Oakland University William Beaumont School of Medicine, Royal Oak, MI, USA.'}, {'ForeName': 'Yao-Chi', 'Initials': 'YC', 'LastName': 'Chuang', 'Affiliation': 'Department of Urology, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, 123 Ta Pei Road, Niao Song District, Kaohsiung, Taiwan. chuang82@ms26.hinet.net.'}]",Scientific reports,['10.1038/s41598-021-87040-1'] 2566,33752964,Emergency department visits in African Americans with mild cognitive impairment and diabetes.,"AIMS Dementia, diabetes, and African American race are three factors that are independently associated with emergency department (ED) use. This study tested the hypothesis that ED use is associated with worse cognitive function in African Americans with Mild Cognitive Impairment (MCI) and poorly controlled diabetes. METHODS This study examined differences in ED use among African Americans with MCI and diabetes in a secondary data analysis of baseline data from a one-year randomized controlled trial (N = 101). RESULTS Over one year, 49/92 participants (53.3%) had at least one ED visit. At baseline, participants who had an incident ED visit had significantly fewer years of education; lower scores on neuropsychological tests assessing working memory, psychomotor speed, and complex scanning; higher diabetes-related interpersonal distress scores; lower adherence to a diabetes medication; and higher hemoglobin A1c levels compared to participants with no ED visits (p ≤ 0.05 for all comparisons). CONCLUSIONS This study identified multiple risk factors for ED visits in older African Americans with MCI and diabetes. Targeted interventions may be necessary to reduce the need for ED care in high risk populations.",2021,"At baseline, participants who had an incident ED visit had significantly fewer years of education; lower scores on neuropsychological tests assessing working memory, psychomotor speed, and complex scanning; higher diabetes-related interpersonal distress scores; lower adherence to a diabetes medication; and higher hemoglobin A1c levels compared to participants with no ED visits (p ≤ 0.05 for all comparisons). ","['African Americans with mild cognitive impairment and diabetes', 'African Americans with Mild Cognitive Impairment (MCI) and poorly controlled diabetes', 'African Americans with MCI and diabetes in a secondary data analysis of baseline data from a one-year randomized controlled trial (N\u202f=\u202f101', 'older African Americans with MCI and diabetes']",[],"['neuropsychological tests assessing working memory, psychomotor speed, and complex scanning; higher diabetes-related interpersonal distress scores; lower adherence to a diabetes medication; and higher hemoglobin A1c levels', 'cognitive function']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],"[{'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C2919483', 'cui_str': 'High hemoglobin A1c level'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.194191,"At baseline, participants who had an incident ED visit had significantly fewer years of education; lower scores on neuropsychological tests assessing working memory, psychomotor speed, and complex scanning; higher diabetes-related interpersonal distress scores; lower adherence to a diabetes medication; and higher hemoglobin A1c levels compared to participants with no ED visits (p ≤ 0.05 for all comparisons). ","[{'ForeName': 'Barry W', 'Initials': 'BW', 'LastName': 'Rovner', 'Affiliation': 'Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, PA, United States of America. Electronic address: barry.rovner@jefferson.edu.'}, {'ForeName': 'Robin J', 'Initials': 'RJ', 'LastName': 'Casten', 'Affiliation': 'Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, PA, United States of America. Electronic address: robin.casten@jefferson.edu.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2021.107905'] 2567,33721836,Network analysis of nitrate-sensitive oral microbiome reveals interactions with cognitive function and cardiovascular health across dietary interventions.,"Many oral bacteria reduce inorganic nitrate, a natural part of a vegetable-rich diet, into nitrite that acts as a precursor to nitric oxide, a regulator of vascular tone and neurotransmission. Aging is hallmarked by reduced nitric oxide production with associated detriments to cardiovascular and cognitive function. This study applied a systems-level bacterial co-occurrence network analysis across 10-day dietary nitrate and placebo interventions to test the stability of relationships between physiological and cognitive traits and clusters of co-occurring oral bacteria in older people. Relative abundances of Proteobacteria increased, while Bacteroidetes, Firmicutes and Fusobacteria decreased after nitrate supplementation. Two distinct microbiome modules of co-occurring bacteria, that were sensitive to nitrate supplementation, showed stable relationships with cardiovascular (Rothia-Streptococcus) and cognitive (Neisseria-Haemophilus) indices of health across both dietary conditions. A microbiome module (Prevotella-Veillonella) that has been associated with pro-inflammatory metabolism was diminished after nitrate supplementation, including a decrease in relative abundance of pathogenic Clostridium difficile. These nitrate-sensitive oral microbiome modules are proposed as potential pre- and probiotic targets to ameliorate age-induced impairments in cardiovascular and cognitive health.",2021,"Relative abundances of Proteobacteria increased, while Bacteroidetes, Firmicutes and Fusobacteria decreased after nitrate supplementation.",['older people'],[],"['Relative abundances of Proteobacteria increased, while Bacteroidetes, Firmicutes and Fusobacteria']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0751985', 'cui_str': 'Proteobacteria'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1003893', 'cui_str': 'Fusobacteria'}]",,0.0824511,"Relative abundances of Proteobacteria increased, while Bacteroidetes, Firmicutes and Fusobacteria decreased after nitrate supplementation.","[{'ForeName': 'Anni', 'Initials': 'A', 'LastName': 'Vanhatalo', 'Affiliation': 'College of Life and Environmental Sciences, University of Exeter, UK. Electronic address: a.vanhatalo@exeter.ac.uk.'}, {'ForeName': 'Joanna E', 'Initials': 'JE', 'LastName': ""L'Heureux"", 'Affiliation': 'College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kelly', 'Affiliation': 'College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Jamie R', 'Initials': 'JR', 'LastName': 'Blackwell', 'Affiliation': 'College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Lee J', 'Initials': 'LJ', 'LastName': 'Wylie', 'Affiliation': 'College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Fulford', 'Affiliation': 'NIHR Exeter Clinical Research Facility, University of Exeter, UK.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Winyard', 'Affiliation': 'College of Medicine and Health, University of Exeter, UK.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Williams', 'Affiliation': 'School of Dentistry, Cardiff University, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'van der Giezen', 'Affiliation': 'Department of Chemistry, Bioscience and Environmental Engineering, University of Stavanger, Norway.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Jones', 'Affiliation': 'College of Life and Environmental Sciences, University of Exeter, UK.'}]",Redox biology,['10.1016/j.redox.2021.101933'] 2568,33721765,CT-FFR vs a model of combined plaque characteristics for identifying ischemia: Results from CT-FFR CHINA trial.,"OBJECTIVES To evaluate the diagnostic performance of fractional flow reserve (FFR) derived from coronary computed tomography angiography (CCTA; CT-FFR) and combined plaque characteristics for ischemia in different CCTA stenosis levels. METHODS This clinical trial analyzed 317 patients with 30 %-90 % coronary stenosis in 366 vessels from 5 centers undergoing CCTA and invasive FFR. 366 vessels were assigned into < 50 % (nonobstructive) and ≥ 50 % (obstructive) stenosis groups. Lesion length (LL), plaque burden (PB), diameter stenosis (DS), volume ratio of plaque subcomponents < 30 HU (VR < 30HU), and high-risk features were analyzed. Logistic regression models were used to identify plaque characteristic predictors for lesion-specific ischemia in different stenosis grades. The area under receiver operating characteristics curve (AUC) of integrated plaque characteristics and CT-FFR were calculated and compared. RESULTS In < 50 % stenosis lesions, PB (OR: 1.296, p = 0.002), LL (OR:1.075, p = 0.020), and DS (OR:1.085, p = 0.031) were independent predictors of ischemia. In ≥ 50 % stenosis lesions, VR < 30HU (OR:1.031, p = 0.005) and DS (OR: 1.020, p =  0.044) were independent predictors for ischemia. AUC of plaque characteristic (VR < 30HU plus DS) for ischemia was 0.67 (95 % CI: 0.61-0.72) in ≥ 50 % stenosis level, which was significantly lower than CT-FFR (AUC=0.90; 95 % CI: 0.86-0.93) (p <  0.001). For lesions causing < 50 % stenosis, AUC of combined plaque model (VR < 30HU plus DS) was 0.88 (95 % CI: 0.80-0.95), equivalent to AUC of CT-FFR (AUC = 0.88; 95 % CI: 0.80-0.96; p =  0.957). CONCLUSION CT-FFR is a powerful functional assessment tool for both obstructive and nonobstructive diseases. However, for nonobstructive CAD confirmed by CCTA, a model of a combination of plaque characteristics could be a valuable alternative to CT-FFR.",2021,AUC of plaque characteristic (VR < 30HU plus DS) for ischemia was 0.67,"['366 vessels were assigned into < 50 % (nonobstructive) and ≥ 50 % (obstructive) stenosis groups', 'ischemia', '317 patients with 30 %-90 % coronary stenosis in 366 vessels from 5 centers undergoing CCTA and invasive FFR']","['CT-FFR', 'coronary computed tomography angiography (CCTA; CT-FFR']","['LL', 'area under receiver operating characteristics curve (AUC) of integrated plaque characteristics and CT-FFR', 'AUC of plaque characteristic (VR < 30HU plus DS', 'DS', 'diagnostic performance of fractional flow reserve (FFR', 'Lesion length (LL), plaque burden (PB), diameter stenosis (DS), volume ratio of plaque subcomponents < 30 HU (VR\u2009<\u200930HU), and high-risk features']","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242231', 'cui_str': 'Coronary artery stenosis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}]","[{'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",317.0,0.0777638,AUC of plaque characteristic (VR < 30HU plus DS) for ischemia was 0.67,"[{'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhao', 'Affiliation': 'Department of Radiology, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 167 North Lishi Road, Xicheng District, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Radiology, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 167 North Lishi Road, Xicheng District, Beijing, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Catheterization Laboratories, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 167 North Lishi Road, Xicheng District, Beijing, 100037, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': 'Department of Radiology, Beijing Chao-Yang Hospital, Capital Medical University, No. 8 Gongren Tiyuchang Nanlu, Chaoyang District, Beijing, 100020, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiology, Beijing Chao-Yang Hospital, Capital Medical University, No. 8 Gongren Tiyuchang Nanlu, Chaoyang District, Beijing, 100020, China.'}, {'ForeName': 'Hongjie', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'Department of Radiology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, China.'}, {'ForeName': 'Wenqiang', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Qilu Hospital of Shandong University, 107, Jinan Culture Road, Jinan, 250012, China.'}, {'ForeName': 'Dumin', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, Qilu Hospital of Shandong University, 107, Jinan Culture Road, Jinan, 250012, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Teda International Cardiovascular Hospital, 61, Third Avenue, TEDA, Tianjin, 300457, China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'Department of Radiology, Teda International Cardiovascular Hospital, 61, Third Avenue, TEDA, Tianjin, 300457, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Lu', 'Affiliation': 'Department of Radiology, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 167 North Lishi Road, Xicheng District, Beijing, China. Electronic address: blu@vip.sina.com.'}]",European journal of radiology,['10.1016/j.ejrad.2021.109634'] 2569,33721598,"Efficacy of pitolisant in patients with high burden of narcolepsy symptoms: pooled analysis of short-term, placebo-controlled studies.","STUDY OBJECTIVE To evaluate the efficacy of pitolisant, a histamine 3 (H 3 )-receptor antagonist/inverse agonist, in adult patients with high burden of narcolepsy symptoms. METHODS Data were pooled from two randomized, placebo-controlled, 7- or 8-week studies of pitolisant (titrated to a potential maximum dose of 35.6 mg/day) in adults with narcolepsy. Analyses included three independent patient subgroups: Epworth Sleepiness Scale (ESS) baseline score ≥16, Maintenance of Wakefulness Test (MWT) sleep latency ≤8 min, and ≥15 cataplexy attacks per week. RESULTS The analysis populations included 118 patients for ESS (pitolisant, n = 60; placebo, n = 58), 105 for MWT (pitolisant, n = 59; placebo, n = 46), and 31 for cataplexy (pitolisant, n = 20; placebo, n = 11). On the ESS, least-squares mean change from baseline was significantly greater for pitolisant (-6.1) compared with placebo (-2.3; P < 0.001). Significantly more pitolisant-treated patients were classified as treatment responders: ESS score reduction ≥3, 69.0% in the pitolisant group versus 35.1% in the placebo group (P = 0.001); final ESS score ≤10, 36.2% versus 10.5%, respectively (P = 0.005). On the MWT, mean sleep latency increased from 3.5 min to 10.4 min with pitolisant and from 3.4 min to 6.8 min with placebo (P = 0.017). Least-squares mean change in the weekly rate of cataplexy was significantly greater for pitolisant (-14.5; baseline, 23.9; final, 9.4) compared with placebo (-0.1; baseline, 23.1; final, 23.0; P = 0.004). Headache was the most common adverse event with pitolisant. CONCLUSIONS Pitolisant, at once-daily doses up to 35.6 mg, was efficacious for reducing excessive daytime sleepiness and cataplexy in patients with severe narcolepsy symptom burden.",2021,"On the MWT, mean sleep latency increased from 3.5 min to 10.4 min with pitolisant and from 3.4 min to 6.8 min with placebo (P = 0.017).","['patients with high burden of narcolepsy symptoms', 'adults with narcolepsy', 'adult patients with high burden of narcolepsy symptoms', '118 patients for ESS (pitolisant, n\xa0=\xa060; placebo, n\xa0=\xa058), 105 for MWT (pitolisant, n\xa0=\xa059; placebo, n\xa0=\xa046), and 31 for', 'patients with severe narcolepsy symptom burden']","['placebo', 'cataplexy (pitolisant, n\xa0=\xa020; placebo', 'pitolisant', 'histamine 3 (H 3 )-receptor']","['mean sleep latency', 'Epworth Sleepiness Scale (ESS) baseline score ≥16, Maintenance of Wakefulness Test (MWT) sleep latency ≤8\xa0min, and ≥15 cataplexy attacks per week', 'Headache', 'excessive daytime sleepiness', 'rate of cataplexy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0027404', 'cui_str': 'Narcolepsy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0206630', 'cui_str': 'Endometrial stromal sarcoma'}, {'cui': 'C3529928', 'cui_str': 'pitolisant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007384', 'cui_str': 'Cataplexy'}, {'cui': 'C3529928', 'cui_str': 'pitolisant'}, {'cui': 'C0019588', 'cui_str': 'Histamine'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0007384', 'cui_str': 'Cataplexy'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C4551761', 'cui_str': 'Excessive daytime sleepiness'}]",118.0,0.511282,"On the MWT, mean sleep latency increased from 3.5 min to 10.4 min with pitolisant and from 3.4 min to 6.8 min with placebo (P = 0.017).","[{'ForeName': 'Craig W', 'Initials': 'CW', 'LastName': 'Davis', 'Affiliation': 'Harmony Biosciences, LLC, Plymouth Meeting, PA, USA. Electronic address: cdavis@harmonybiosciences.com.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Kallweit', 'Affiliation': 'Universität Witten/Herdecke, Witten, Germany.'}, {'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Schwartz', 'Affiliation': 'Bioprojet Pharma, Paris, France.'}, {'ForeName': 'Lois E', 'Initials': 'LE', 'LastName': 'Krahn', 'Affiliation': 'Mayo Clinic Hospital, Phoenix, AZ, USA.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Vaughn', 'Affiliation': 'Rho, Durham, NC, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Thorpy', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY, USA.'}]",Sleep medicine,['10.1016/j.sleep.2021.02.037'] 2570,33714863,The effect of hand and foot massage on fatigue in hemodialysis patients: A randomized controlled trial.,"OBJECTIVE The aim of this study was to examine the effect of hand massage and foot massage on fatigue in hemodialysis patients. METHODS This randomized, controlled and quasi-experimental study was conducted between October 19, 2018 and February 11, 2019 with patients receiving hemodialysis therapy in the dialysis unit of a public hospital in Turkey. Data were collected using a Patient Identification Form and the Visual Analogue Scale for Fatigue. The study was carried out with 82 patients in three groups: a hand massage group (n = 27), a foot massage group (n = 27) and a control group (n = 28). The patients in the control group were not administered any treatments except for standard nursing interventions in the hemodialysis unit. RESULTS In between-groups comparison the hand and foot massage groups' mean fatigue score decreased after the application compared to that of the control group (p < 0.05). CONCLUSIONS Hand and foot massage were found to reduce fatigue in patients receiving hemodialysis.",2021,"In between-groups comparison the hand and foot massage groups' mean fatigue score decreased after the application compared to that of the control group (p < 0.05). ","['82 patients in three groups: a hand massage group (n\xa0=\xa027), a', 'hemodialysis patients', 'patients receiving hemodialysis', 'October 19, 2018 and February 11, 2019 with patients receiving hemodialysis therapy in the dialysis unit of a public hospital in Turkey']","['foot massage group', 'standard nursing interventions', 'hand and foot massage', 'hand massage and foot massage']","['mean fatigue score', 'Visual Analogue Scale for Fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C1629858', 'cui_str': 'Dialysis unit'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0321237,"In between-groups comparison the hand and foot massage groups' mean fatigue score decreased after the application compared to that of the control group (p < 0.05). ","[{'ForeName': 'Sultan', 'Initials': 'S', 'LastName': 'Çeçen', 'Affiliation': 'Vocational School of Health Services, Therapy and Rehabilitation Department, Hitit University, Çorum, Turkey. Electronic address: sultancecen@hitit.edu.tr.'}, {'ForeName': 'Diğdem', 'Initials': 'D', 'LastName': 'Lafcı', 'Affiliation': 'Mersin University, Faculty of Nursing Fundamentals of Nursing Department, Mersin, Turkey. Electronic address: lafci@mersin.edu.tr.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101344'] 2571,33714843,Site-specific risk factors for local recurrence after rectal cancer surgery.,"BACKGROUND Quite few studies examined risk factors for local recurrence after rectal cancer surgery with respect to local recurrence sites. METHODS Local recurrence sites were categorized into axial, anterior, posterior, and lateral (pelvic sidewall), and axial, anterior, and posterior type were combined as the ""other"" type of local recurrence. Among 76 patients enrolled into our prospective randomized controlled trial to determine the indication for pelvic autonomic nerve preservation (PANP) in patients with advanced lower rectal cancer (UMIN000021353), multivariate analyses were conducted to elucidate risk factors for either lateral or the ""other"" type of local recurrence. RESULTS Univariate analyses showed that tumor distance from the anal verge was significantly (p = 0.017), and type of operation (sphincter preserving operation (SPO) vs. abdominoperineal resection (APR)) was marginally (p = 0.065) associated with pelvic sidewall recurrence. Multivariate analysis using these two parameters showed that tumor distance from the anal verge was significantly and independently correlated with pelvic sidewall recurrence (p = 0.017). As for the ""other"" type of local recurrence, univariate analyses showed that depth of tumor invasion (p = 0.011), radial margin status (p < 0.001), and adjuvant chemotherapy (p = 0.037) were significantly associated, and multivariate analysis using these three parameters revealed that depth of tumor invasion (p = 0.004) and radial margin status (p < 0.001) were significantly and independently correlated with the ""other"" type of local recurrence. CONCLUSION Risk factors for local recurrence after rectal cancer surgery were totally different with respect to the intra-pelvic recurrent sites. Site-specific probability of local recurrence can be inferred using these risk factors. TRIAL REGISTRATION NUMBER UMIN000021353.",2021,Multivariate analysis using these two parameters showed that tumor distance from the anal verge was significantly and independently correlated with pelvic sidewall recurrence (p = 0.017).,"['local recurrence after rectal cancer surgery', '76 patients enrolled', 'patients with advanced lower rectal cancer (UMIN000021353']",['pelvic autonomic nerve preservation (PANP'],"['radial margin status', 'tumor distance from the anal verge', 'pelvic sidewall recurrence', 'type of operation (sphincter preserving operation (SPO) vs. abdominoperineal resection (APR', 'depth of tumor invasion']","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0206250', 'cui_str': 'Autonomic nerve structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}]","[{'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0227423', 'cui_str': 'Structure of transition zone of anal mucous membrane'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C2004459', 'cui_str': 'Abdominoperineal resection'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}]",76.0,0.088155,Multivariate analysis using these two parameters showed that tumor distance from the anal verge was significantly and independently correlated with pelvic sidewall recurrence (p = 0.017).,"[{'ForeName': 'Tadahiko', 'Initials': 'T', 'LastName': 'Masaki', 'Affiliation': 'Department of Surgery, Kyorin University, Japan. Electronic address: masaki@ks.kyorin-u.ac.jp.'}, {'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Matsuoka', 'Affiliation': 'Department of Surgery, Kyorin University, Japan.'}, {'ForeName': 'Tomokazu', 'Initials': 'T', 'LastName': 'Kishiki', 'Affiliation': 'Department of Surgery, Kyorin University, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Kojima', 'Affiliation': 'Department of Surgery, Kyorin University, Japan.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Tonari', 'Affiliation': 'Department of Surgery, Kyorin University, Japan.'}, {'ForeName': 'Nobuyoshi', 'Initials': 'N', 'LastName': 'Aso', 'Affiliation': 'Department of Surgery, Kyorin University, Japan.'}, {'ForeName': 'Ayumi', 'Initials': 'A', 'LastName': 'Beniya', 'Affiliation': 'Department of Surgery, Kyorin University, Japan.'}, {'ForeName': 'Aiko', 'Initials': 'A', 'LastName': 'Iioka', 'Affiliation': 'Department of Surgery, Kyorin University, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Wakamatsu', 'Affiliation': 'Department of Surgery, Kyorin University, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Sunami', 'Affiliation': 'Department of Surgery, Kyorin University, Japan.'}]",Surgical oncology,['10.1016/j.suronc.2021.101540'] 2572,33714071,"Erratum to 'Controlled drug delivery systems in eradicating bacterial biofilm-associated infections' [Journal of Controlled Release, Volume 329 (10 January 2021) 1102-1116].",,2021,,[],[],[],[],[],[],,0.0671359,,"[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""State Key Laboratory of Medicinal Chemical Biology, Key Laboratory of Functional Polymer Materials, Ministry of Education, Institute of Polymer Chemistry, College of Chemistry, Nankai University, 94 Weijin Road, Tianjin 300071, PR China; Jiangsu Key Laboratory for Carbon-Based Functional Materials & Devices, Institute of Functional Nano & Soft Materials (FUNSOM), Collaborative Innovation Center of Suzhou Nano Science and Technology, Soochow University, 199 Ren'ai Road, Suzhou 215123, PR China.""}, {'ForeName': 'Yuanfeng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Medicinal Chemical Biology, Key Laboratory of Functional Polymer Materials, Ministry of Education, Institute of Polymer Chemistry, College of Chemistry, Nankai University, 94 Weijin Road, Tianjin 300071, PR China; University of Groningen and University Medical Center Groningen, Department of Biomedical Engineering, Antonius Deusinglaan 1, 9713, AV, Groningen, the Netherlands.'}, {'ForeName': 'Linqi', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'State Key Laboratory of Medicinal Chemical Biology, Key Laboratory of Functional Polymer Materials, Ministry of Education, Institute of Polymer Chemistry, College of Chemistry, Nankai University, 94 Weijin Road, Tianjin 300071, PR China. Electronic address: shilinqi@nankai.edu.cn.'}]",Journal of controlled release : official journal of the Controlled Release Society,['10.1016/j.jconrel.2021.02.034'] 2573,33745805,Does the impact of intensive lifestyle intervention on cognitive function vary depending baseline level of frailty? An ancillary study to the Action for Health in Diabetes (Look AHEAD) Trial.,"AIMS To assess whether there is an opportune window when intensive lifestyle intervention (ILI) benefits cognitive function. METHODS Standardized cognitive assessments were collected following ≥8 years of either ILI or a control condition of diabetes support and education (DSE) in 3708 individuals, ages 45-76 years at enrollment, with type 2 diabetes and overweight or obesity. Frailty index (FI) scores were used to group individuals at baseline into tertiles according to their age-related health status. Linear models were used to describe intervention adherence and cognitive function, with interaction terms to examine the consistency of relationships among tertiles. RESULTS Worse baseline FI scores were associated with poorer subsequent performance in tests of attention, processing speed, and executive function. No differences in any measure of cognitive function were observed between intervention groups within any FI tertile (all p > 0.10). Among individuals with worse baseline FI scores, weight gain was associated with poorer global cognitive function among participants assigned to DSE. There was no association between weight changes and cognitive function among participants assigned to ILI. CONCLUSIONS Among adults with type 2 diabetes and overweight/obesity, we found no evidence that there is a window of opportunity based on FI when ILI benefits cognitive function.",2021,No differences in any measure of cognitive function were observed between intervention groups within any FI tertile (all p > 0.10).,"['Health in Diabetes (Look AHEAD', 'Standardized cognitive assessments were collected following ≥8\u202fyears of either ILI or a control condition of diabetes support and education (DSE) in 3708 individuals, ages 45-76\u202fyears at enrollment, with type 2 diabetes and overweight or obesity', 'adults with type 2 diabetes and overweight/obesity']",['intensive lifestyle intervention'],"['attention, processing speed, and executive function', 'global cognitive function', 'Frailty index (FI) scores', 'weight gain', 'weight changes and cognitive function', 'cognitive function']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4075886', 'cui_str': 'Frailty Index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]",,0.0685347,No differences in any measure of cognitive function were observed between intervention groups within any FI tertile (all p > 0.10).,"[{'ForeName': 'Felicia R', 'Initials': 'FR', 'LastName': 'Simpson', 'Affiliation': 'Department of Mathematics, Winston-Salem State University, 601 S. Martin Luther King Jr. Drive, Winston-Salem, NC 27110, United States of America.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Carmichael', 'Affiliation': 'Institute for Dementia Research and Prevention, Pennington Biomedical Research Center, Baton Rouge, LA 70808, United States of America.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Hayden', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest University, Winston-Salem, NC 27101, United States of America.'}, {'ForeName': 'Christina E', 'Initials': 'CE', 'LastName': 'Hugenschmidt', 'Affiliation': ""Sticht Center for Healthy Aging and Alzheimer's Prevention, Wake Forest School of Medicine, One Medical Center Blvd, Winston-Salem, NC 27101, United States of America.""}, {'ForeName': 'Jeanne M', 'Initials': 'JM', 'LastName': 'McCaffery', 'Affiliation': 'Department of Allied Health Sciences, University of Connecticut, Storrs, CT 06269, United States of America.'}, {'ForeName': 'Sevil', 'Initials': 'S', 'LastName': 'Yasar', 'Affiliation': 'Departrment of Medicine, Johns Hopkins School of Medicine, Baltimore, MD 21224, United States of America.'}, {'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Pajewski', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, One Medical Center Blvd, Winston-Salem, NC 27101, United States of America.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Espeland', 'Affiliation': ""Sticht Center for Healthy Aging and Alzheimer's Prevention, Wake Forest School of Medicine, One Medical Center Blvd, Winston-Salem, NC 27101, United States of America; Department of Biostatistics and Data Science, Wake Forest School of Medicine, One Medical Center Blvd, Winston-Salem, NC 27101, United States of America. Electronic address: mespelan@wakehealth.edu.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2021.107909'] 2574,33745731,Effect of a 2+1 schedule of ten-valent versus 13-valent pneumococcal conjugate vaccine on pneumococcal carriage: Results from a randomised controlled trial in Vietnam.,"BACKGROUND Pneumococcal conjugate vaccines (PCVs) generate herd protection by reducing nasopharyngeal (NP) carriage. Two PCVs, PCV10 and PCV13, have been in use for over a decade, yet there are few data comparing their impact on carriage. Here we report their effect on carriage in a 2+1 schedule, compared with each other and with unvaccinated controls. METHODS Data from four groups within a parallel, open-label randomised controlled trial in Ho Chi Minh City contribute to this article. Three groups were randomised to receive a 2+1 schedule of PCV10 (n = 250), a 2+1 schedule of PCV13 (n = 251), or two doses of PCV10 at 18 and 24 months (controls, n = 197). An additional group (n = 199) was recruited at 18 months to serve as controls from 18 to 24 months. NP swabs collected at 2, 6, 9, 12, 18, and 24 months were analysed (blinded) for pneumococcal carriage. This study aimed to determine if PCV10 and PCV13 have a differential effect on pneumococcal carriage, a secondary outcome of the trial. We also describe the serotype distribution among unvaccinated participants. TRIAL REGISTRATION ClinicalTrials.gov NCT01953510. FINDINGS Compared with unvaccinated controls, a 2+1 schedule of PCV10 reduced PCV10-type carriage by 45-62% from pre-booster through to 24 months of age, and a 2+1 schedule of PCV13 reduced PCV13-type carriage by 36-49% at 12 and 18 months of age. Compared directly with each other, there were few differences between the vaccines in their impact on carriage. Vaccine serotypes accounted for the majority of carriage in unvaccinated participants. INTERPRETATION Both PCV10 and PCV13 reduce the carriage of pneumococcal vaccine serotypes. The introduction of either vaccine would have the potential to generate significant herd protection in this population. FUNDING National Health and Medical Research Council of Australia, Bill & Melinda Gates Foundation.",2021,"Compared with unvaccinated controls, a 2+1 schedule of PCV10 reduced PCV10-type carriage by 45-62% from pre-booster through to 24 months of age, and a 2+1 schedule of PCV13 reduced PCV13-type carriage by 36-49% at 12 and 18 months of age.","['pneumococcal carriage', 'Vietnam', 'unvaccinated participants']","['PCV13', 'valent versus 13-valent pneumococcal conjugate vaccine', 'PCV10 and PCV13', 'PCV10', 'vaccine']","['carriage of pneumococcal vaccine serotypes', 'PCV10-type carriage', 'PCV13-type carriage']","[{'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}]","[{'cui': 'C3152625', 'cui_str': 'Pneumococcal 13-valent conjugate vaccine'}, {'cui': 'C3849486', 'cui_str': '10-valent pneumococcal conjugate vaccine'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0358314', 'cui_str': 'Pneumococcal vaccine'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C3849486', 'cui_str': '10-valent pneumococcal conjugate vaccine'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",,0.448438,"Compared with unvaccinated controls, a 2+1 schedule of PCV10 reduced PCV10-type carriage by 45-62% from pre-booster through to 24 months of age, and a 2+1 schedule of PCV13 reduced PCV13-type carriage by 36-49% at 12 and 18 months of age.","[{'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Temple', 'Affiliation': ""Global and Tropical Health Division, Menzies School of Health Research, Charles Darwin University, Darwin, NT, Australia; Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK; Infection and Immunity, Murdoch Children's Research Institute, Melbourne, VIC, Australia.""}, {'ForeName': 'Monica Larissa', 'Initials': 'ML', 'LastName': 'Nation', 'Affiliation': ""Infection and Immunity, Murdoch Children's Research Institute, Melbourne, VIC, Australia.""}, {'ForeName': 'Vo Thi Trang', 'Initials': 'VTT', 'LastName': 'Dai', 'Affiliation': 'Department of Microbiology and Immunology, Pasteur Institute of Ho Chi Minh City, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Jemima', 'Initials': 'J', 'LastName': 'Beissbarth', 'Affiliation': 'Child Health Division, Menzies School of Health Research, Charles Darwin University, Darwin, NT, Australia.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Bright', 'Affiliation': ""Infection and Immunity, Murdoch Children's Research Institute, Melbourne, VIC, Australia.""}, {'ForeName': 'Eileen Margaret', 'Initials': 'EM', 'LastName': 'Dunne', 'Affiliation': ""Infection and Immunity, Murdoch Children's Research Institute, Melbourne, VIC, Australia; Department of Paediatrics, The University of Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Hinds', 'Affiliation': ""Institute for Infection and Immunity, St George's, University of London, London, UK; BUGS Bioscience, London Bioscience Innovation Centre, London, UK.""}, {'ForeName': 'Pham Thi', 'Initials': 'PT', 'LastName': 'Hoan', 'Affiliation': 'Department of Microbiology and Immunology, Pasteur Institute of Ho Chi Minh City, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Lai', 'Affiliation': 'Child Health Division, Menzies School of Health Research, Charles Darwin University, Darwin, NT, Australia.'}, {'ForeName': 'Cattram Duong', 'Initials': 'CD', 'LastName': 'Nguyen', 'Affiliation': ""Infection and Immunity, Murdoch Children's Research Institute, Melbourne, VIC, Australia; Department of Paediatrics, The University of Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Belinda Daniela', 'Initials': 'BD', 'LastName': 'Ortika', 'Affiliation': ""Infection and Immunity, Murdoch Children's Research Institute, Melbourne, VIC, Australia.""}, {'ForeName': 'Thanh V', 'Initials': 'TV', 'LastName': 'Phan', 'Affiliation': 'Department of Microbiology and Immunology, Pasteur Institute of Ho Chi Minh City, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Ho Nguyen Loc', 'Initials': 'HNL', 'LastName': 'Thuy', 'Affiliation': 'Department of Microbiology and Immunology, Pasteur Institute of Ho Chi Minh City, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Nguyen Trong', 'Initials': 'NT', 'LastName': 'Toan', 'Affiliation': 'Department of Disease Control and Prevention, Pasteur Institute of Ho Chi Minh City, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Doan Y', 'Initials': 'DY', 'LastName': 'Uyen', 'Affiliation': 'Department of Disease Control and Prevention, Pasteur Institute of Ho Chi Minh City, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Satzke', 'Affiliation': ""Infection and Immunity, Murdoch Children's Research Institute, Melbourne, VIC, Australia; Department of Paediatrics, The University of Melbourne, Melbourne, VIC, Australia; Department of Microbiology and Immunology, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia.""}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Smith-Vaughan', 'Affiliation': 'Child Health Division, Menzies School of Health Research, Charles Darwin University, Darwin, NT, Australia.'}, {'ForeName': 'Tran Ngoc', 'Initials': 'TN', 'LastName': 'Huu', 'Affiliation': 'Department of Disease Control and Prevention, Pasteur Institute of Ho Chi Minh City, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Mulholland', 'Affiliation': ""Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK; Infection and Immunity, Murdoch Children's Research Institute, Melbourne, VIC, Australia. Electronic address: kim.mulholland@lshtm.ac.uk.""}]",Vaccine,['10.1016/j.vaccine.2021.02.043'] 2575,33744963,Revisiting Co-Trimoxazole Prophylaxis for African Adults in The Era of Antiretroviral Therapy: A Randomized Controlled Clinical Trial.,"BACKGROUND Daily co-trimoxazole is recommended for African adults living with HIV irrespective of antiretroviral treatment, immune status, or disease stage. Benefits of continued prophylaxis and whether co-trimoxazole can be stopped following immune reconstitution are unknown. METHODS We conducted a randomized, controlled trial at two sites in Malawi that enrolled HIV-infected adults with undetectable viral load and CD4 count of >250/mm 3 and randomized them to continue daily co-trimoxazole, discontinue daily co-trimoxazole and begin weekly chloroquine, or discontinue daily co-trimoxazole. The primary endpoint was the preventive effect of co-trimoxazole prophylaxis against death or World Health Organization (WHO) HIV/AIDS Stage 3-4 events, using Cox proportional hazards modelling, intention to treat population. RESULTS 1499 adults were enrolled. The preventive effect of co-trimoxazole on the primary endpoint was 22% (95%CI -14-47%, p=0.20) versus no prophylaxis and 25% (95%CI -10-48%, p=0.14) versus chloroquine. When WHO HIV/AIDS Stage 2 events were added to the primary endpoint, preventive effect increased to 31% (95%CI 3-51%, p=0.032) and 32% (95%CI 4-51%, p=0.026), respectively. Co-trimoxazole and chloroquine prophylaxis effectively prevented clinical malaria episodes (3.8 and 3.0, respectively, versus 28/100 person-years, p<0.001). CONCLUSIONS Malawian adults living with HIV who immune reconstituted on ART and continued co-trimoxazole prophylaxis experienced fewer deaths and WHO HIV/AIDS Stage 3-4 events compared to prophylaxis discontinuation, though statistical significance was not achieved. Cotrimoxazole prevented a composite of death plus WHO HIV/AIDS Stage 2-4 events. Given poor healthcare access and lack of routine viral load monitoring, co-trimoxazole prophylaxis should continue in adults on ART after immune reconstitution in sub-Saharan Africa.",2021,"The preventive effect of co-trimoxazole on the primary endpoint was 22% (95%CI -14-47%, p=0.20) versus no prophylaxis and 25% (95%CI -10-48%, p=0.14) versus chloroquine.","['two sites in Malawi that enrolled HIV-infected adults with undetectable viral load and CD4 count of >250/mm 3 and randomized them to', '1499 adults were enrolled', 'African Adults in The Era of Antiretroviral Therapy', 'African adults living with HIV irrespective of antiretroviral treatment, immune status, or disease stage']","['Co-trimoxazole and chloroquine prophylaxis', 'Cotrimoxazole', 'Revisiting Co-Trimoxazole Prophylaxis', 'Daily co-trimoxazole', 'co-trimoxazole', 'chloroquine', 'continue daily co-trimoxazole, discontinue daily co-trimoxazole and begin weekly chloroquine, or discontinue daily co-trimoxazole']","['preventive effect', 'preventive effect of co-trimoxazole prophylaxis against death or World Health Organization (WHO) HIV/AIDS Stage 3-4 events, using Cox proportional hazards modelling, intention to treat population', 'clinical malaria episodes']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C1521863', 'cui_str': 'estrogen receptor alpha, human'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0020964', 'cui_str': 'Immune status'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0041044', 'cui_str': 'sulfamethoxazole and trimethoprim'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0041044', 'cui_str': 'sulfamethoxazole and trimethoprim'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0033551', 'cui_str': 'Prostaglandin synthase'}, {'cui': 'C0205351', 'cui_str': 'Proportional'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4543807', 'cui_str': 'Clinical malaria'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",1499.0,0.471535,"The preventive effect of co-trimoxazole on the primary endpoint was 22% (95%CI -14-47%, p=0.20) versus no prophylaxis and 25% (95%CI -10-48%, p=0.14) versus chloroquine.","[{'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Laurens', 'Affiliation': 'Malaria Research Program, Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland, United States.'}, {'ForeName': 'Randy G', 'Initials': 'RG', 'LastName': 'Mungwira', 'Affiliation': 'Blantyre Malaria Project, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Nginache', 'Initials': 'N', 'LastName': 'Nampota', 'Affiliation': 'Blantyre Malaria Project, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Osward M', 'Initials': 'OM', 'LastName': 'Nyirenda', 'Affiliation': 'Blantyre Malaria Project, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Titus H', 'Initials': 'TH', 'LastName': 'Divala', 'Affiliation': 'Blantyre Malaria Project, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Maxwell', 'Initials': 'M', 'LastName': 'Kanjala', 'Affiliation': 'Blantyre Malaria Project, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Felix A', 'Initials': 'FA', 'LastName': 'Mkandawire', 'Affiliation': 'Blantyre Malaria Project, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Lufina Tsirizani', 'Initials': 'LT', 'LastName': 'Galileya', 'Affiliation': 'Blantyre Malaria Project, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Wongani', 'Initials': 'W', 'LastName': 'Nyangulu', 'Affiliation': 'Dignitas International, Zomba, Malawi.'}, {'ForeName': 'Edson', 'Initials': 'E', 'LastName': 'Mwinjiwa', 'Affiliation': 'Dignitas International, Zomba, Malawi.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Downs', 'Affiliation': 'Statistics Collaborative, Washington, DC, United States.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Tillman', 'Affiliation': 'Statistics Collaborative, Washington, DC, United States.'}, {'ForeName': 'Terrie E', 'Initials': 'TE', 'LastName': 'Taylor', 'Affiliation': 'Blantyre Malaria Project, University of Malawi College of Medicine, Blantyre, Malawi, and College of Osteopathic Medicine, Michigan State University, East Lansing, Michigan, United States.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Mallewa', 'Affiliation': 'University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Christopher V', 'Initials': 'CV', 'LastName': 'Plowe', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, Maryland, United States.'}, {'ForeName': 'Joep J', 'Initials': 'JJ', 'LastName': 'van Oosterhout', 'Affiliation': 'Dignitas International and University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Miriam K', 'Initials': 'MK', 'LastName': 'Laufer', 'Affiliation': 'Malaria Research Program, Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland, United States.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciab252'] 2576,33744668,Association of skin infections with sharing of injection drug preparation equipment among people who inject drugs.,"BACKGROUND Sharing needles and injection drug preparation equipment (IDPE) among people who inject drugs (PWID) are well-established risk factors for viral transmission. Shared needles and IDPE may serve as bacterial niduses for skin and soft tissue infections (SSTI). Given the rising rates of SSTI in PWID, we investigated the association of needle and IDPE sharing on incidence of SSTI in a cohort of PWID. METHODS Inpatient PWID (N = 252) were recruited to a randomized controlled trial of an intervention aimed at reducing infections. The primary outcome was self-reported incidence of SSTI one-year post-hospitalization. In this secondary analysis, we assessed two variables: 1) sharing of IDPE alone, 2) sharing needles with or without IDPE, and compared these groups separately to persons who reported no sharing of needles or IDPE via a mixed-effects negative binomial regression model to estimate the effect of baseline sharing behavior on SSTI during follow-up via incidence rate ratios (IRR). RESULTS Participant characteristics: 38 years [mean], 58% male, 60% White, 90% primarily injected opioids, 1.58 (± 2.35) mean SSTI in the year prior to baseline. In terms of sharing behavior, 29% didn't share needles or IDPE, 13% shared IDPE only, and 58% shared needles with or without IDPE three months prior to baseline. After adjusting for co-variables, PWID who shared IDPE alone had a 2.2 fold higher IRR of SSTI (95%CI 1.27; 3.85, p = 0.005) and PWID who shared needles with or without IDPE had a 3.31 fold higher IRR of SSTI (95%CI 2.04; 5.37, p < 0.001), compared to those who did not share any equipment. The number of SSTI at baseline was associated with an IRR of 1.20 of SSTI during follow-up (95%CI 1.09; 1.32, p < 0.001). CONCLUSIONS In this cohort of hospitalized PWID, we found a significant association between baseline sharing of IDPE alone and of sharing of needles with or without IDPE with one-year incidence of SSTI.",2021,"The number of SSTI at baseline was associated with an IRR of 1.20 of SSTI during follow-up (95%CI 1.09; 1.32, p < 0.001). ","['people who inject drugs (PWID', 'Inpatient PWID (N\xa0=\xa0252', 'people who inject drugs', 'Participant characteristics: 38 years [mean], 58% male, 60% White, 90% primarily injected opioids, 1.58 (± 2.35']","['Sharing needles and injection drug preparation equipment (IDPE', 'IDPE alone, 2) sharing needles with or without IDPE']","['IRR of SSTI', 'self-reported incidence of SSTI one-year post-hospitalization', 'number of SSTI']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]","[{'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0013164', 'cui_str': 'Drug Preparation'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}]","[{'cui': 'C0083017', 'cui_str': 'insulin receptor-related receptor'}, {'cui': 'C0149778', 'cui_str': 'Soft tissue infection'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",252.0,0.158976,"The number of SSTI at baseline was associated with an IRR of 1.20 of SSTI during follow-up (95%CI 1.09; 1.32, p < 0.001). ","[{'ForeName': 'Raagini', 'Initials': 'R', 'LastName': 'Jawa', 'Affiliation': 'Section of Infectious Diseases, Boston Medical Center, 801 Massachusetts Ave, 2nd floor, Boston 02118, MA, USA. Electronic address: raagini.jawa@bmc.org.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Stein', 'Affiliation': 'Boston University School of Public Health, Boston, MA, USA; Behavioral Medicine and Addictions Research, Butler Hospital, Providence, RI, USA.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Anderson', 'Affiliation': 'Behavioral Medicine and Addictions Research, Butler Hospital, Providence, RI, USA.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Liebschutz', 'Affiliation': 'Division of General Internal Medicine, Center for Research on Health Care, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Stewart', 'Affiliation': 'Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Kristina T', 'Initials': 'KT', 'LastName': 'Phillips', 'Affiliation': 'Center for Integrated Health Care Research, Kaiser Permanente Hawaii.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Barocas', 'Affiliation': 'Section of Infectious Diseases, Boston Medical Center, 801 Massachusetts Ave, 2nd floor, Boston 02118, MA, USA; Boston University School of Medicine, Boston, MA, USA.'}]",The International journal on drug policy,['10.1016/j.drugpo.2021.103198'] 2577,33744393,Immersive virtual reality is effective in the rehabilitation of older adults with balance disorders: A randomized clinical trial.,"QUESTION What are the effects of immersive virtual reality (IVR) training compared to conventional physiotherapy on body balance and risk of falls in older adults with balance disorders? DESIGN A randomized controlled trial with two intervention arms, concealed allocation, per-protocol analysis, and blinded assessment. PARTICIPANTS Thirty-seven older adults with balance disorders and risk of falling. INTERVENTION Participants were randomized into two groups: a control group, which received balance training with conventional physiotherapy using multimodal circuit exercises, and an experimental group, which received balance training using immersive virtual reality. Both groups received 16 individual sessions, twice a week. OUTCOME MEASURES The primary outcome was functional balance. Secondary outcomes were static balance, gait speed, functional range, dizziness symptoms, and fear of falling. Safety was ensured by assessing any adverse events during the intervention. RESULTS After 16 sessions, in the intragroup analysis, the functional balance score in the experimental group increased by 3.00 (95% CI 1.42 to 4.57) and in the control group by 3.88 (95% CI 2.16 to 5.59). Both groups improved in assessments of sensory interaction and anterior reach. Only the experimental group presented increased mobility and reduced dizziness. After two months, there was a maintenance of gains in functional balance and a reduction of the gains in functional reach for both groups. In the intergroup comparison, there was no significant difference. CONCLUSION Immersive Virtual Reality training proved to be effective for balance-related outcomes, although it was not superior to conventional therapy. TRIAL REGISTRATION RBR-3tk7fw.",2021,"Participants were randomized into two groups: a control group, which received balance training with conventional physiotherapy using multimodal circuit exercises, and an experimental group, which received balance training using immersive virtual reality.","['older adults with balance disorders', 'Thirty-seven older adults with balance disorders and risk of falling']","['Immersive virtual reality', 'immersive virtual reality (IVR) training', 'Immersive Virtual Reality training', 'conventional physiotherapy', 'balance training with conventional physiotherapy using multimodal circuit exercises, and an experimental group, which received balance training using immersive virtual reality']","['mobility and reduced dizziness', 'sensory interaction and anterior reach', 'adverse events', 'functional balance score', 'static balance, gait speed, functional range, dizziness symptoms, and fear of falling', 'functional balance', 'body balance and risk of falls']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0575090', 'cui_str': 'Balance disorder'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",37.0,0.0458854,"Participants were randomized into two groups: a control group, which received balance training with conventional physiotherapy using multimodal circuit exercises, and an experimental group, which received balance training using immersive virtual reality.","[{'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Lima Rebêlo', 'Affiliation': 'Health Sciences from the Federal University of Alagoas, Physiotherapy Department, State University of Health Sciences of Alagoas and Cesmac University Center, Maceió, Brazil; Health Sciences Graduate Program (PPGCS), Federal University of Sergipe, Aracaju, SE, Brazil; State University of Health Sciences of Alagoas, Maceió, Brazil; Department of Physiotherapy, Cesmac University Center, Maceió, Brazil. Electronic address: feliperebelo_fisio@yahoo.com.br.'}, {'ForeName': 'Luiz Fellipe', 'Initials': 'LF', 'LastName': 'de Souza Silva', 'Affiliation': 'State University of Health Sciences of Alagoas, Maceió, Brazil.'}, {'ForeName': 'Flávia', 'Initials': 'F', 'LastName': 'Doná', 'Affiliation': 'Health Sciences, Ibirapuera University, Physiotherapy Department, São Paulo, Brazil.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Sales Barreto', 'Affiliation': 'Health Sciences Graduate Program (PPGCS), Federal University of Sergipe, Aracaju, SE, Brazil; Health Sciences, Federal University of Sergipe, Health Education Department, Aracaju, Brazil.'}, {'ForeName': 'Jullyana', 'Initials': 'J', 'LastName': 'de Souza Siqueira Quintans', 'Affiliation': 'Health Sciences, Physiology Department, Health Sciences Graduate Program (PPGCS), Federal University of Sergipe, Aracaju, SE, Brazil.'}]",Experimental gerontology,['10.1016/j.exger.2021.111308'] 2578,33744043,The effectiveness of vibratory stimulation in reducing pain in children receiving vaccine injection: A randomized controlled trial.,"BACKGROUND Although vaccine injections are important, children experience pain and discomfort upon their administration. BUZZY®, a vibratory stimulation tool with an ice pack, was reported to be an effective tool for reducing the pain caused to children during injection administration; its mechanisms were explained by gate control theory. However, the evidence is inadequate because of insufficient methodology in previous reports. Therefore, we aimed to assess whether the application of vibration would significantly reduce children's pain during vaccine injections. METHODS A single-blind randomized controlled trial recruiting children aged ≤6 years who were receiving vaccine injections was conducted between August and December 2019. If the children's parents consented to their participation, BUZZY® was attached to the child's arm prior to vaccination. BUZZY® was switched on before injection in the intervention group but not in the control group. The vaccination procedure was recorded, and researchers and parents assessed each child's pain using validated pain scales. Researchers conducted their assessment using video data to ensure blinding. Parents were administered a questionnaire after the children's vaccination. Data were analyzed using the t-test or chi-square test. RESULTS We analyzed 118 children (intervention group = 62, control = 56). No between-group difference was observed according to the researchers' assessment (mean score = 6.98 and 7.63, respectively; p = 0.25); however, a significant difference was found based on the parents' assessment (mean score = 7.39 versus 8.46; p = 0.02). Most responses received to open-ended questions were positive comments for this study. CONCLUSIONS We revealed that the effect of vibration is not significant in reducing vaccine injection pain among children. Further studies are needed to examine the other components of BUZZY®, which include its cooling effect, and the effect of BUZZY® itself in terms of whether children will undergo vaccination without resistance and have reduced trauma related to vaccination.",2021,"No between-group difference was observed according to the researchers' assessment (mean score = 6.98 and 7.63, respectively; p = 0.25); however, a significant difference was found based on the parents' assessment (mean score = 7.39 versus 8.46; p = 0.02).","['children', 'children receiving vaccine injection', '118 children (intervention group\xa0=\xa062, control\xa0=\xa056', 'children aged ≤6\xa0years who were receiving']","['vaccine injections', 'vibratory stimulation']","['vaccine injection pain', ""children's pain"", 'pain']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1096717', 'cui_str': 'Pain during injection'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",118.0,0.201776,"No between-group difference was observed according to the researchers' assessment (mean score = 6.98 and 7.63, respectively; p = 0.25); however, a significant difference was found based on the parents' assessment (mean score = 7.39 versus 8.46; p = 0.02).","[{'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Ueki', 'Affiliation': ""School of Nursing, Mukogawa Women's University, 6-46, Ikebiraki, Nishinomiya, Hyogo 668-8558, Japan. Electronic address: ueki@mukogawa-u.ac.jp.""}, {'ForeName': 'Eriko', 'Initials': 'E', 'LastName': 'Matsunaka', 'Affiliation': 'Faculty of Nursing, Japanese Red Cross Kyushu International College of Nursing, 1-1, Asty, Munakata, Fukuoka 811-4157, Japan. Electronic address: e-matsunaka@jrckicn.ac.jp.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Takao', 'Affiliation': 'Faculty of Health and Medical Sciences, Kyoto University of Advanced Science, 18, Gotanda, Yamanouchi, Ukyou, Kyoto, Kyoto 615-8577, Japan. Electronic address: takao.kenji@kuas.ac.jp.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Kitao', 'Affiliation': ""School of Nursing, Mukogawa Women's University, 6-46, Ikebiraki, Nishinomiya, Hyogo 668-8558, Japan. Electronic address: kitao@mukogawa-u.ac.jp.""}, {'ForeName': 'Minae', 'Initials': 'M', 'LastName': 'Fukui', 'Affiliation': ""School of Nursing, Mukogawa Women's University, 6-46, Ikebiraki, Nishinomiya, Hyogo 668-8558, Japan. Electronic address: fukui_m@mukogawa-u.ac.jp.""}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Fujita', 'Affiliation': ""School of Nursing, Mukogawa Women's University, 6-46, Ikebiraki, Nishinomiya, Hyogo 668-8558, Japan. Electronic address: yfujita@mukogawa-u.ac.jp.""}]",Vaccine,['10.1016/j.vaccine.2021.03.013'] 2579,33743343,Mindfulness-based intervention to promote psychological wellbeing in people with epilepsy: A randomized controlled trial.,"BACKGROUND We investigated the efficacy of mindfulness-based intervention (MBI) in promoting psychological wellbeing in people with epilepsy (PWE) using an assessor-blinded randomized controlled design. METHODS A total of 28 PWE were randomly assigned to either intervention (n = 14 cases) or control group (n = 14 controls). The intervention group received a six 2.5-hour weekly MBI, while the control group did not receive any intervention. They were assessed at three timepoints (T0: before intervention, T1: immediately after intervention, and T2: 6 weeks after intervention). Repeated measures of analyses of variance (RM-ANOVAs) were used for inter-group comparisons to determine intervention effect from baseline -to T1 and -to T2 for all outcome measures. The individual changes were calculated using the reliable change index (RCI). Key outcomes included depression (BDI-II), anxiety (BAI), epilepsy-related quality of life (QOLIE-31), satisfaction with life (SWLS), and level of mindfulness (MAAS). RESULTS Participants who participated in the MBI showed significant reduction in BDI-II (p = 0.001), significant increases in MAAS (p = 0.027) and QOLIE-31 (p = 0.001) at T1 when compared with the control group. However, BAI and SWLS were not significant. The trend was similar at 6-week follow-up, all outcome measures of MBI remained significant (p < 0.05) except for BAI and SWLS. Beyond the 6-week intervention, RCI analysis showed a significant improvement in levels of mindfulness (45.45% vs. 21.43%, p = 0.009), depression (45.45% vs. 0.00%, p = 0.016), quality of life (45.45% vs. 14.29%, p = 0.017) with MBI, as compared to the no-intervention phase. CONCLUSION Mindfulness-based intervention is effective in reducing psychological distress and improving the quality of life in PWE.",2021,"RESULTS Participants who participated in the MBI showed significant reduction in BDI-II (p = 0.001), significant increases in MAAS (p = 0.027) and QOLIE-31 (p = 0.001) at T1 when compared with the control group.","['A total of 28 PWE', 'people with epilepsy (PWE', 'people with epilepsy']","['six 2.5-hour weekly MBI, while the control group did not receive any intervention', 'Mindfulness-based intervention', 'mindfulness-based intervention (MBI']","['depression', 'QOLIE-31', 'BDI-II', 'quality of life', 'psychological distress', 'BAI and SWLS', 'MAAS', 'levels of mindfulness', 'MBI', 'quality of life in PWE', 'depression (BDI-II), anxiety (BAI), epilepsy-related quality of life (QOLIE-31), satisfaction with life (SWLS), and level of mindfulness (MAAS']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}]","[{'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",28.0,0.0687758,"RESULTS Participants who participated in the MBI showed significant reduction in BDI-II (p = 0.001), significant increases in MAAS (p = 0.027) and QOLIE-31 (p = 0.001) at T1 when compared with the control group.","[{'ForeName': 'Siew-Tim', 'Initials': 'ST', 'LastName': 'Lai', 'Affiliation': 'Division of Neurology, Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Kheng-Seang', 'Initials': 'KS', 'LastName': 'Lim', 'Affiliation': 'Division of Neurology, Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia. Electronic address: kslimum@gmail.com.'}, {'ForeName': 'Venus', 'Initials': 'V', 'LastName': 'Tang', 'Affiliation': 'Department of Clinical Psychology, Prince of Wales Hospital, Hospital Authority, Hong Kong; Division of Neurosurgery, Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Wah-Yun', 'Initials': 'WY', 'LastName': 'Low', 'Affiliation': 'Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia; Asia-Europe Institute, University of Malaya, Kuala Lumpur, Malaysia.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2021.107916'] 2580,33743290,Nutritional risk is a predictor for long-term mortality: 5-Year follow-up of the EFFORT trial.,"BACKGROUND AND AIMS The nutritional risk screening (NRS 2002) is a validated screening tool for malnutrition. This study aims to investigate the prognostic value of the NRS 2002 and its individual components regarding long-term mortality and adverse outcomes in a well-characterized cohort of medical inpatients. METHODS We performed a 5-year follow-up investigation of patients included in the investigator-initiated, prospective, randomized controlled multicenter EFFORT trial that evaluated the effects of individualized nutritional intervention vs. standard hospital food. We used multivariable cox regression analyses adjusted for randomisation arm, study centre, comorbidities and main admission diagnosis to investigate associations between NRS 2002 total scores at time of hospital admission and several long-term outcomes. RESULTS We had confirmed mortality data over the mean follow-up time of 3.2 years in 1874 from the initial cohort of 2028 EFFORT patients. Mortality showed a step-wise increase in patients with NRS 3 (289/565 [51.2%]) and NRS 4 (355/717 [49.6%]) to 59.5% (353/593) in patient with NRS≥5 corresponding to an adjusted Hazard Ratio (HR) of 1.28 (95%CI 1.15 to 1.42, p ≤ 0.001) for mortality after one year and 1.13 (95%CI 1.05 to 1.23, p = 0.002) for the overall time period. All individual components of NRS including disease severity, food intake, weight loss and BMI provided prognostic information regarding long-term mortality risk. CONCLUSION Nutritional risk mirrored by a NRS 2002 total score is a strong and independent predictor of long-term mortality and morbidity in polymorbid medical inpatients particularly in patients with high nutritional risk with an NRS ≥5 points.",2021,"Mortality showed a step-wise increase in patients with NRS 3 (289/565 [51.2%]) and NRS 4 (355/717 [49.6%]) to 59.5% (353/593) in patient with NRS≥5 corresponding to an adjusted Hazard Ratio (HR) of 1.28 (95%CI 1.15 to 1.42, p ≤ 0.001) for mortality after one year and 1.13 (95%CI 1.05 to 1.23, p = 0.002) for the overall time period.","['a well-characterized cohort of medical inpatients', 'polymorbid medical inpatients particularly in patients with high nutritional risk with an NRS ≥5 points']",['individualized nutritional intervention vs. standard hospital food'],"['disease severity, food intake, weight loss and BMI provided prognostic information regarding long-term mortality risk', 'Nutritional risk', 'mortality', 'Mortality']","[{'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1268620', 'cui_str': 'At risk for nutritional problem'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1268620', 'cui_str': 'At risk for nutritional problem'}]",2028.0,0.0632958,"Mortality showed a step-wise increase in patients with NRS 3 (289/565 [51.2%]) and NRS 4 (355/717 [49.6%]) to 59.5% (353/593) in patient with NRS≥5 corresponding to an adjusted Hazard Ratio (HR) of 1.28 (95%CI 1.15 to 1.42, p ≤ 0.001) for mortality after one year and 1.13 (95%CI 1.05 to 1.23, p = 0.002) for the overall time period.","[{'ForeName': 'Andriana', 'Initials': 'A', 'LastName': 'Efthymiou', 'Affiliation': 'Division of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Hersberger', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Reber', 'Affiliation': 'Division of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Katja A', 'Initials': 'KA', 'LastName': 'Schönenberger', 'Affiliation': 'Inselspital, Bern, Switzerland.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Kägi-Braun', 'Affiliation': 'Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Tribolet', 'Affiliation': 'Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Mueller', 'Affiliation': 'Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Schuetz', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland. Electronic address: schuetzph@gmail.com.'}, {'ForeName': 'Zeno', 'Initials': 'Z', 'LastName': 'Stanga', 'Affiliation': 'Division of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, and University of Bern, Bern, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2021.02.032'] 2581,33751924,Treatment of Distal Radius Fracture During Immobilization with an Orthopedic Cast: A Double-Blinded Randomized Controlled Trial of Photobiomodulation Therapy.,"Objective: With distal radius fracture (DRF) many patients experience stiffness and pain after removal of the cast. The aim of this study was to investigate possible effects of photobiomodulation therapy (PBMT) in DRF during immobilization with semicircular orthopedic cast. Methods: In this double-blinded, placebo-controlled trial, 53 patients with DRF were randomized to receive nine treatments of either PBMT or placebo-PBMT. The fractures were irradiated through openings in the cast. Patient-Rated Wrist and Hand Evaluation (PRWHE) questionnaire and clinical outcomes were measured at baseline, 4, 8, 12, and 26 weeks after the trauma. Results: No significant differences were found for PRWHE scores, although PBMT was significantly superior to placebo regarding active range of motion [AROM; 95% (confidence interval) CI: -65.25° to -20.42° and -25.57° to -0.73°, respectively] and grip strength at week 4 (95% CI: -12.10 to -1.67 kg). Side-to-side differences between injured and noninjured wrists were significantly smaller in the PBMT group regarding grip and pinch strength at week 4 (95% CI: 0.89 to 8.87 kg and 0.55 to 3.79 kg, respectively). Significantly less patients in the PBMT group reported night pain at week 3. Conclusions: PBMT administered during the immobilization period of DRF had no effect on perceived pain and function measured through PRWHE. Night pain was significantly reduced after 3 weeks by PBMT. PBMT significantly improved pinch and grip strength and AROM, but these findings did not translate to the subjective experience of pain and function. Trial registration number: Clinical.trials.gov number NCT02749929. The study was approved by the Regional ethics committee (REK-Vest) in Norway (App. No: 2015/330). Informed consent was obtained from all patients.",2021,"No significant differences were found for PRWHE scores, although PBMT was significantly superior to placebo regarding active range of motion [AROM; 95% (confidence interval) CI: -65.25° to -20.42° and -25.57° to -0.73°, respectively] and grip strength at week 4 (95% CI: -12.10 to -1.67 kg).",['53 patients with DRF'],"['PBMT or placebo-PBMT', 'PBMT', 'Distal Radius Fracture', 'placebo', 'photobiomodulation therapy (PBMT', 'distal radius fracture (DRF']","['night pain', 'pinch and grip strength and AROM', 'pain and function', 'Night pain', 'Patient-Rated Wrist and Hand Evaluation (PRWHE) questionnaire and clinical outcomes', 'grip strength', 'PRWHE scores', 'subjective experience of pain and function', 'grip and pinch strength']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}]","[{'cui': 'C0234255', 'cui_str': 'Night pain'}, {'cui': 'C0418416', 'cui_str': 'Pinched'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0003805', 'cui_str': 'Androstenedione Aromatase'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C1720876', 'cui_str': 'Pinch Strength'}]",53.0,0.673214,"No significant differences were found for PRWHE scores, although PBMT was significantly superior to placebo regarding active range of motion [AROM; 95% (confidence interval) CI: -65.25° to -20.42° and -25.57° to -0.73°, respectively] and grip strength at week 4 (95% CI: -12.10 to -1.67 kg).","[{'ForeName': 'Humaira', 'Initials': 'H', 'LastName': 'Saebø', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Ingvill Fjell', 'Initials': 'IF', 'LastName': 'Naterstad', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Jan Magnus', 'Initials': 'JM', 'LastName': 'Bjordal', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Martin Bjørn', 'Initials': 'MB', 'LastName': 'Stausholm', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Joensen', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}]","Photobiomodulation, photomedicine, and laser surgery",['10.1089/photob.2020.4964'] 2582,33751906,Effects of l-Theanine on Cognitive Function in Middle-Aged and Older Subjects: A Randomized Placebo-Controlled Study.,"l-theanine ( γ -glutamylethylamide), an amino acid in green tea, has been shown to affect brain functions by relieving stress disorders, improving mood, and maintaining normal sleep. However, the cognitive functions for which theanine is effective are unclear. This study aimed to clarify which cognitive functions are positively affected by intake of l-theanine. A double-blind, randomized, placebo-controlled study was conducted. The subjects were Japanese men and women aged 50-69 years. Mini Mental State Examination-Japanese version score was 24 or higher. Cognitrax was used as a test battery for cognitive function. Evaluations were performed before the intervention, after a single dose of l-theanine, and after 12 weeks of regular intake. The single dose of l-theanine reduced the reaction time to attention tasks (Stroop test, Part 1), and it increased the number of correct answers and decreased the number of omission errors in working memory tasks (4-Part continuous performance test, Part 4). In conclusion, our study indicated that l-theanine may contribute to improving attention, thus enhancing working memory and executive functions. Clinical Trial No.: UMIN000033812.",2021,"The single dose of l-theanine reduced the reaction time to attention tasks (Stroop test, Part 1), and it increased the number of correct answers and decreased the number of omission errors in working memory tasks (4-Part continuous performance test, Part 4).","['subjects were Japanese men and women aged 50-69 years', 'Middle-Aged and Older Subjects']","['Placebo', 'l-theanine ( γ -glutamylethylamide', 'placebo', 'l-Theanine']","['number of omission errors in working memory tasks (4-Part continuous performance test, Part 4', 'Mini Mental State Examination-Japanese version score', 'Cognitive Function', 'reaction time to attention tasks (Stroop test, Part 1']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0076380', 'cui_str': 'theanine'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}]",,0.167001,"The single dose of l-theanine reduced the reaction time to attention tasks (Stroop test, Part 1), and it increased the number of correct answers and decreased the number of omission errors in working memory tasks (4-Part continuous performance test, Part 4).","[{'ForeName': 'Yoshitake', 'Initials': 'Y', 'LastName': 'Baba', 'Affiliation': 'Central Research Institute, ITO EN, LTD., Shizuoka, Japan.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Inagaki', 'Affiliation': 'Central Research Institute, ITO EN, LTD., Shizuoka, Japan.'}, {'ForeName': 'Sae', 'Initials': 'S', 'LastName': 'Nakagawa', 'Affiliation': 'Central Research Institute, ITO EN, LTD., Shizuoka, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Kaneko', 'Affiliation': 'Tokyo Skytree Station Medical Clinic, Tokyo, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Kobayashi', 'Affiliation': 'Central Research Institute, ITO EN, LTD., Shizuoka, Japan.'}, {'ForeName': 'Takanobu', 'Initials': 'T', 'LastName': 'Takihara', 'Affiliation': 'Central Research Institute, ITO EN, LTD., Shizuoka, Japan.'}]",Journal of medicinal food,['10.1089/jmf.2020.4803'] 2583,33750239,"Titrating the Smell of Fear: Initial Evidence for Dose-Invariant Behavioral, Physiological, and Neural Responses.","It is well accepted that emotional intensity scales with stimulus strength. Here, we used physiological and neuroimaging techniques to ask whether human body odor-which can convey salient social information-also induces dose-dependent effects on behavior, physiology, and neural responses. To test this, we first collected sweat from 36 males classified as low-, medium-, and high-fear responders. Next, in a double-blind within-subjects functional-MRI design, 31 women were exposed to three doses of fear-associated human chemosignals and neutral sweat while viewing face morphs varying between expressions of fear and disgust. Behaviorally, we found that all doses of fear-sweat volatiles biased participants toward perceiving fear in ambiguous morphs, a dose-invariant effect generally repeated across physiological and neural measures. Bayesian dose-response analysis indicated moderate evidence for the null hypothesis (except for the left amygdala), tentatively suggesting that the human olfactory system engages an all-or-none mechanism for tagging fear above a minimal threshold.",2021,"Bayesian dose-response analysis indicated moderate evidence for the null hypothesis (except for the left amygdala), tentatively suggesting that the human olfactory system engages an all-or-none mechanism for tagging fear above a minimal threshold.","['36 males classified as low-, medium-, and high-fear responders']",[],[],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]",[],[],31.0,0.039926,"Bayesian dose-response analysis indicated moderate evidence for the null hypothesis (except for the left amygdala), tentatively suggesting that the human olfactory system engages an all-or-none mechanism for tagging fear above a minimal threshold.","[{'ForeName': 'Jasper H B', 'Initials': 'JHB', 'LastName': 'de Groot', 'Affiliation': 'Department of Neurology, University of Pennsylvania.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Kirk', 'Affiliation': 'Department of Neurology, University of Pennsylvania.'}, {'ForeName': 'Jay A', 'Initials': 'JA', 'LastName': 'Gottfried', 'Affiliation': 'Department of Neurology, University of Pennsylvania.'}]",Psychological science,['10.1177/0956797620970548'] 2584,33754940,Weight Status and Effects of Non-Tobacco Flavors on E-Cigarette Product Appeal.,"BACKGROUND Flavors in tobacco products may be salient drivers of tobacco product use among people with overweight or obesity. Yet, whether perceived appeal of e-cigarettes with different flavors varies as a function of weight status is unknown. Purpose: To conduct secondary data analyses of a laboratory experiment to examine whether weight moderates differences in perceived appeal of fruit, menthol, and tobacco flavored e-cigarettes in young adults who vape. Methods: Using a within-subjects experimental design, young adults in Los Angeles, CA, USA. (Mage = 25.36 ± 4.42 Range: 18-35) with normal weight (n = 48) or overweight/obesity (n = 51) were administered standardized doses of e-cigarette solutions varying in flavor (fruit, menthol, tobacco). Following each administration, participants rated the appeal of the solution (range: 0-100). Results: The extent to which menthol (vs. tobacco)-flavored e-cigarettes were rated more appealing was amplified among participants with overweight or obesity versus normal weight participants (flavor × weight interaction Estimate = 7.54, p = .01 95% CI = [2.30, 12.80]). There were no differences in the effects of fruit (vs. tobacco) flavored e-cigarettes on appeal as a function of weight status. Conclusions: Menthol flavors in e-cigarettes may be disproportionately appealing to young adults with overweight and obesity. Supplemental data for this article is available online at https://doi.org/10.1080/10826084.2021.1899229.",2021,There were no differences in the effects of fruit (vs. tobacco) flavored e-cigarettes on appeal as a function of weight status.,"['Mage = 25.36\u2009±\u20094.42 Range: 18-35) with normal weight (n\u2009=\u200948) or overweight/obesity (n\u2009=\u200951', 'young adults with overweight and obesity', 'people with overweight or obesity', 'young adults who vape']","['e-cigarette solutions varying in flavor (fruit, menthol, tobacco']",[],"[{'cui': 'C4517762', 'cui_str': '4.42'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0291011', 'cui_str': 'VAPE protocol'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}]",[],,0.200616,There were no differences in the effects of fruit (vs. tobacco) flavored e-cigarettes on appeal as a function of weight status.,"[{'ForeName': 'Tyler B', 'Initials': 'TB', 'LastName': 'Mason', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Leventhal', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, Los Angeles, California, USA.'}]",Substance use & misuse,['10.1080/10826084.2021.1899229'] 2585,33745962,Cardiovascular reactivity to acute stress: Attachment styles and invisible stranger support.,"While the benefits of social support for physiological health are well established, the underlying pathways by which support can influence cardiovascular reactivity (CVR) are still being elucidated. In the present study, we adapted an attachment framework to further explore the support-CVR link. Specifically, we experimentally tested the effect of attachment and social support on CVR by manipulating the provision of invisible support from a stranger, across individuals with secure, anxious and avoidant attachment styles. Employing a 3 × 2 design, a sample of young adults (N = 138) from across each of the three attachment styles were randomly assigned to either an invisible support (from a stranger), or no support, condition. All participants were subject to an acute standardised stress testing protocol where cardiovascular indices were monitored throughout. Results from a factorial ANOVA showed no significant interaction between support and attachment on any cardiovascular reactivity parameter (SBP, DBP, HR) or any main effect of attachment or support. These findings suggest that, in this case, social support was not effective in buffering the effects of stress across various attachment styles. The benefits of incorporating a developmental perspective to the study of social support and health are discussed.",2021,"Results from a factorial ANOVA showed no significant interaction between support and attachment on any cardiovascular reactivity parameter (SBP, DBP, HR) or any main effect of attachment or support.","['individuals with secure, anxious and avoidant attachment styles', 'young adults (N\u202f=\u202f138) from across each of the three attachment styles']","['invisible support (from a stranger), or no support, condition']","['cardiovascular reactivity parameter (SBP, DBP, HR']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0205398', 'cui_str': 'Invisible'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",,0.0339225,"Results from a factorial ANOVA showed no significant interaction between support and attachment on any cardiovascular reactivity parameter (SBP, DBP, HR) or any main effect of attachment or support.","[{'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'McMahon', 'Affiliation': 'Department of Psychology, Centre for Social Issues Research, Study of Anxiety, Stress and Health Laboratory, University of Limerick, Limerick, Ireland; Health Research Institute, University of Limerick, Ireland. Electronic address: grace.mcmahon@ul.ie.'}, {'ForeName': 'Ann-Marie', 'Initials': 'AM', 'LastName': 'Creaven', 'Affiliation': 'Department of Psychology, Centre for Social Issues Research, Study of Anxiety, Stress and Health Laboratory, University of Limerick, Limerick, Ireland; Health Research Institute, University of Limerick, Ireland.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Gallagher', 'Affiliation': 'Department of Psychology, Centre for Social Issues Research, Study of Anxiety, Stress and Health Laboratory, University of Limerick, Limerick, Ireland; Health Research Institute, University of Limerick, Ireland.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2021.03.005'] 2586,33745460,Adiponectin and 8-epi-PGF 2α as intermediate influencing factors in weight reduction after legume consumption: a 12-week randomised controlled trial.,"Legumes are rich sources of essential nutrients, and their potential health benefits were reported in many studies. Several studies showed a positive effect of legumes on obesity, but randomised clinical trials are limited in the Korean population. The present intervention study investigated the impact of legumes on body weight in obese Korean subjects. A total of 400 participants (BMI ≥ 25 kg/m2) were randomised into two groups. The legume-enriched diet (LD) group replaced one-third of their refined rice consumption with legumes three times per day as a carbohydrate source. In contrast, the usual diet (UD) group consumed their UD. The mean weight loss at 12 weeks was 2·87 (sem 0·21) kg and 0·17 (sem 0·11) kg in the LD and UD, respectively, which was significantly different between the groups (P < 0·001). HDL-cholesterol and adiponectin levels were increased, and levels of glucose, insulin, TAG, and 8-epi-PGF2α and the homoeostasis model assessment of insulin resistance (IR) index value decreased at 12 weeks compared with baseline in the LD. The consumption of legumes may accelerate weight loss accompanied by regulation of adiponectin and 8-epi-PGF2α in obese subjects. In particular, legumes seemed to induce significant changes in BMI by increasing adiponectin in females. Additionally, increases in plasma adiponectin due to greater substantial weight loss may be related to the improvement in IR.",2021,"High-density lipoprotein cholesterol and adiponectin levels were increased, and levels of glucose, insulin, triglycerides, and 8-epi-prostaglandin F2α (8-epi-PGF2α) and the homeostasis model assessment of insulin resistance index value decreased at 12 weeks compared to baseline in the LD.","['obese Korean subjects', '400 participants [body mass index (BMI) ≥ 25 kg/m2', 'obese subjects', 'weight reduction after legume consumption']","['Adiponectin and 8-epi-PGF 2α', 'usual diet group (UD) consumed their usual diet']","['BMI', 'levels of glucose, insulin, triglycerides, and 8-epi-prostaglandin F2α (8-epi-PGF2α) and the homeostasis model assessment of insulin resistance index value', 'body weight', 'mean weight loss', 'High-density lipoprotein cholesterol and adiponectin levels', 'plasma adiponectin']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0023263', 'cui_str': 'Pea family'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0033561', 'cui_str': 'F series prostaglandin'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",400.0,0.0449258,"High-density lipoprotein cholesterol and adiponectin levels were increased, and levels of glucose, insulin, triglycerides, and 8-epi-prostaglandin F2α (8-epi-PGF2α) and the homeostasis model assessment of insulin resistance index value decreased at 12 weeks compared to baseline in the LD.","[{'ForeName': 'Youngmin', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, Seoul, South Korea.'}, {'ForeName': 'A Ram', 'Initials': 'AR', 'LastName': 'Kim', 'Affiliation': 'Department of Science for Aging, Graduate School of Yonsei University, Seoul, South Korea.'}, {'ForeName': 'Jong Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, Seoul, South Korea.'}, {'ForeName': 'Minjoo', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Department of Food and Nutrition, College of Life Science and Nano Technology, Hannam University, Daejeon, South Korea.'}]",The British journal of nutrition,['10.1017/S0007114521000970'] 2587,33744876,Machine Learning for Prediction and Risk Stratification of Lupus Nephritis Renal Flare.,"BACKGROUND Renal flare of lupus nephritis (LN) is strongly associated with poor kidney outcomes, and predicting renal flare and stratifying its risk are important for clinical decision-making and individualized management to reduce LN flare. METHODS We randomly divided 1,694 patients with biopsy-proven LN, who had achieved remission after treatment, into a derivation cohort (n = 1,186) and an internal validation cohort (n = 508), at a ratio of 7:3. The risk of renal flare 5 years after remission was predicted using an eXtreme Gradient Boosting (XGBoost) method model, developed from 59 variables, including demographic, clinical, immunological, pathological, and therapeutic characteristics. A simplified risk score prediction model (SRSPM) was developed from important variables selected by XGBoost model using stepwise Cox regression for practical convenience. RESULTS The 5-year relapse rates were 39.5% and 38.2% in the derivation and internal validation cohorts, respectively. Both the XGBoost model and the SRSPM had good predictive performance, with a C-index of 0.819 (95% confidence interval [CI]: 0.774-0.857) and 0.746 (95% CI: 0.697-0.795), respectively, in the validation cohort. The SRSPM comprised 6 variables, including partial remission and endocapillary hypercellularity at baseline, age, serum Alb, anti-dsDNA, and serum complement C3 at the point of remission. Using Kaplan-Meier analysis, the SRSPM identified significant risk stratification for renal flares (p < 0.001). CONCLUSIONS Renal flare of LN can be readily predicted using the XGBoost model and the SRSPM, and the SRSPM can also stratify flare risk. Both models are useful for clinical decision-making and individualized management in LN.",2021,"Using Kaplan-Meier analysis, the SRSPM identified significant risk stratification for renal flares (p < 0.001). ","['1,694 patients with biopsy-proven LN, who had achieved remission after treatment, into a derivation cohort (n = 1,186) and an internal validation cohort (n = 508), at a ratio of 7:3']",['Machine Learning'],"['5-year relapse rates', 'partial remission and endocapillary hypercellularity', 'renal flares']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0024143', 'cui_str': 'SLE glomerulonephritis syndrome'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0376284', 'cui_str': 'Machine Learning'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}]",1694.0,0.0262823,"Using Kaplan-Meier analysis, the SRSPM identified significant risk stratification for renal flares (p < 0.001). ","[{'ForeName': 'Yinghua', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'National Clinical Research Centre of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.'}, {'ForeName': 'Siwan', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Ping An Healthcare Technology, Beijing, China.'}, {'ForeName': 'Tiange', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Ping An Healthcare Technology, Beijing, China.'}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Liang', 'Affiliation': 'National Clinical Research Centre of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'National Clinical Research Centre of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.'}, {'ForeName': 'Caihong', 'Initials': 'C', 'LastName': 'Zeng', 'Affiliation': 'National Clinical Research Centre of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Ping An Healthcare Technology, Beijing, China.'}, {'ForeName': 'Guotong', 'Initials': 'G', 'LastName': 'Xie', 'Affiliation': 'Ping An Healthcare Technology, Beijing, China.'}, {'ForeName': 'ZhiHong', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'National Clinical Research Centre of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China, liuzhihong@nju.edu.cn.'}]",American journal of nephrology,['10.1159/000513566'] 2588,33744844,Perspectives of Inpatients With Cirrhosis and Caregivers on Using Health Information Technology: Cross-sectional Multicenter Study.,"BACKGROUND Health information technology (IT) interventions to decrease readmissions for cirrhosis may be limited by patient-associated factors. OBJECTIVE The aim of this study was to determine perspectives regarding adoption versus refusal of health IT interventions among patient-caregiver dyads. METHODS Inpatients with cirrhosis and their caregivers were approached to participate in a randomized health IT intervention trial requiring daily contact with research teams via the Patient Buddy app. This app focuses on ascites, medications, and hepatic encephalopathy over 30 days. Regression analyses for characteristics associated with acceptance were performed. For those who declined, a semistructured interview was performed with themes focused on caregivers, protocol, transport/logistics, technology demands, and privacy. RESULTS A total of 349 patient-caregiver dyads were approached (191 from Virginia Commonwealth University, 56 from Richmond Veterans Affairs Medical Center, and 102 from Mayo Clinic), 87 of which (25%) agreed to participate. On regression, dyads agreeing included a male patient (odds ratio [OR] 2.08, P=.01), gastrointestinal bleeding (OR 2.3, P=.006), or hepatic encephalopathy admission (OR 2.0, P=.01), whereas opioid use (OR 0.46, P=.03) and alcohol-related etiology (OR 0.54, P=.02) were associated with refusal. Race, study site, and other admission reasons did not contribute to refusing participation. Among the 262 dyads who declined randomization, caregiver reluctance (43%), perceived burden (31%), technology-related issues (14%), transportation/logistics (10%), and others (4%), but not privacy, were highlighted as major concerns. CONCLUSIONS Patients with cirrhosis admitted with hepatic encephalopathy and gastrointestinal bleeding without opioid use or alcohol-related etiologies were more likely to participate in a health IT intervention focused on preventing readmissions. Caregiver and study burden but not privacy were major reasons to decline participation. Reducing perceived patient-caregiver burden and improving communication may improve participation. TRIAL REGISTRATION ClinicalTrials.gov NCT03564626; https://www.clinicaltrials.gov/ct2/show/NCT03564626.",2021,"In the 262 dyads who declined randomization caregiver reluctance (43%), perceived burden (31%), technology-related issues (14%), transportation/logistics (10%) and others (4%), but not privacy, were major concerns. ","['Inpatients with Cirrhosis and Caregivers on Using Health Information Technology', 'Patients with cirrhosis admitted with HE and GI bleeding without opioid use or alcohol-related etiologies', '349 patient-caregiver dyads were approached (191 VCU, 56 VA and 102 Mayo) of which 87 dyads (25%) agreed to participate', 'Inpatients with cirrhosis and their caregivers']",['health-IT interventions requiring daily contact with research teams via the PatientBuddy App'],"['GI bleeding', 'HE admission']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C2936756', 'cui_str': 'Health Information Technology'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019151', 'cui_str': 'Hepatic encephalopathy'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}, {'cui': 'C0019151', 'cui_str': 'Hepatic encephalopathy'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",,0.0927104,"In the 262 dyads who declined randomization caregiver reluctance (43%), perceived burden (31%), technology-related issues (14%), transportation/logistics (10%) and others (4%), but not privacy, were major concerns. ","[{'ForeName': 'Chathur', 'Initials': 'C', 'LastName': 'Acharya', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA, United States.'}, {'ForeName': 'Tejasav S', 'Initials': 'TS', 'LastName': 'Sehrawat', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic School of Medicine, Rochester, MN, United States.'}, {'ForeName': 'Deborah B', 'Initials': 'DB', 'LastName': 'McGuire', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA, United States.'}, {'ForeName': 'Jawaid', 'Initials': 'J', 'LastName': 'Shaw', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA, United States.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fagan', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA, United States.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'McGeorge', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA, United States.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Olofson', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic School of Medicine, Rochester, MN, United States.'}, {'ForeName': 'Melanie B', 'Initials': 'MB', 'LastName': 'White', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA, United States.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Gavis', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA, United States.'}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Kamath', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic School of Medicine, Rochester, MN, United States.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Bergstrom', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic School of Medicine, Rochester, MN, United States.'}, {'ForeName': 'Jasmohan Singh', 'Initials': 'JS', 'LastName': 'Bajaj', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA, United States.'}]",Journal of medical Internet research,['10.2196/24639'] 2589,33744815,"Situation, Background, Assessment, and Recommendation Stepwise Education Program: A quasi-experimental study.","BACKGROUND A nurse, as the main subject of decision-making in clinical settings, experiences various situations that require communication with a range of health care providers. The communication process is important to the process of recognizing problems and choosing one among the available alternatives after reflection, which requires communication skills based on critical thinking. Communication competence is one of the basic competencies of nurses, and it is also important for providing qualitative healthcare service. OBJECTIVE To investigate how Situation, Background, Assessment, and Recommendation Stepwise Education Program (SBAR SEP) developed on the basis of the revised Bloom's Taxonomy affects nursing students on their communication competence and critical thinking. DESIGN Non-equivalent control group pretest-posttest design. SETTINGS A university in South Korea. PARTICIPANTS A total of 96 nursing college students (48 in the experimental group and 48 in the control group). METHOD The subjects were allocated using convenience sampling to one of the two groups: SBAR SEP or control. Subjects in SBAR SEP group received a lecture-style training of SBAR a week prior to clinical practicum and performed role-play during the two-week clinical practicum. The duration of the SBAR SEP role-play intervention was 2 weeks, twice a week, for 120 min each session. A control group performed a regular case presentation in the clinical practicum. Data were collected from August to October 2019. Data were analyzed using descriptive statistics, χ 2 test, independent t-test, and ANCOVA using SPSS 25.0. RESULTS A significant increase was observed in the scores of communication competence (p < .001) and critical thinking (p < .001) in the experimental group compared with the control group. CONCLUSIONS The SBAR SEP for nursing students is an effective educational method that improves communication competence and critical thinking under similar circumstances at the clinical site.",2021,"A significant increase was observed in the scores of communication competence (p < .001) and critical thinking (p < .001) in the experimental group compared with the control group. ","['Program', 'A total of 96 nursing college students (48 in the experimental group and 48 in the control group', 'A university in South Korea']","['lecture-style training of SBAR', 'SBAR SEP or control']","['scores of communication competence', 'critical thinking']","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}]","[{'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C4279941', 'cui_str': 'Critical Thinking'}]",,0.0180064,"A significant increase was observed in the scores of communication competence (p < .001) and critical thinking (p < .001) in the experimental group compared with the control group. ","[{'ForeName': 'Jisun', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, Honam University, 100, Honamdae-gil, Gwangsan-gu, Gwangju 62399, Republic of Korea. Electronic address: 2018091@honam.ac.kr.'}]",Nurse education today,['10.1016/j.nedt.2021.104847'] 2590,33744300,"Improving contraceptive use among Latina adolescents: A cluster-randomized controlled trial evaluating an mHealth application, Health-E You/Salud iTu.","OBJECTIVE To evaluate the effectiveness of Health-E You/Salud iTu, a mobile health application (app), on increasing knowledge, self-efficacy and contraception use among Latina adolescents, its impact on visit quality, and app satisfaction. STUDY DESIGN This study used cluster-randomized controlled trial (CRCT) of 18 school-based health centers (SBHCs). Prior to the visit, intervention participants received the patient-centered contraceptive decision-making support app and controls answered sexual health questions on iPads. Participants completed a previsit questionnaire and 3 follow-up surveys (48 hours, 3-, and 6-months) after the recruitment visit (where intervention participants completed the app). Differences in adolescents' contraceptive knowledge, self-efficacy, and use over the 6-month follow-up were assessed by generalized mixed effects regression models. RESULTS A total of 1,360 Latina adolescents participated; 57.2% responded to the 48-hour survey, 50.1% to the 3-month, 49.7% to the 6-month, and 42.3% to both the 3- and 6-month surveys. Health-E You users' demonstrated significant increases in pre-post knowledge (p < 0.001). Intervention participants who completed the follow-up survey reported greater increases in mean self-efficacy from baseline (23.2 intervention vs. 22.5 controls) to 6 months (26.1 vs. 23.4; b = 1.58, 95% CI 0.38-2.77, p = 0.01), and greater increases in non-barrier contraceptive use from baseline (29% intervention vs. 30% controls) to 3 months (63% vs. 45%; OR = 3.29, 95% CI 1.04-10.36, p = 0.04) and 6 months (63% vs. 44%; OR = 5.54, 95% CI 1.70-18.06, p = 0.005). Providers and adolescents reported high app satisfaction and stated it improved visit quality. CONCLUSIONS While data suggest that Health-E You improved outcomes, findings must be interpreted cautiously. Intervention participants had higher baseline sexual activity rates, more recruitment visits for pregnancy testing, emergency contraception or birth control, and lower completion rates of follow-up surveys than controls.",2021,"Intervention participants had higher rates of sexual activity at baseline, more of their recruitment visits were for pregnancy testing, emergency contraception or birth control, and they had lower completion rates of follow-up surveys than controls.","['Latina Adolescents', '1,360 Latina adolescents', '18 school-based health centers (SBHCs', 'Latina adolescents']",['patient-centered contraceptive decision-making support app and controls answered sexual health questions on iPads'],"['rates of sexual activity', ""adolescents' contraceptive knowledge, self-efficacy"", 'pregnancy testing, emergency contraception or birth control', 'Health-E', 'mean self-efficacy', 'Improving Contraceptive Use', 'non-barrier contraceptive', 'effectiveness and efficiency of care', 'visit quality, and adolescent and provider satisfaction']","[{'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0475309', 'cui_str': 'Health center'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0150185', 'cui_str': 'Decision making encouragement'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0032976', 'cui_str': 'Pregnancy detection examination'}, {'cui': 'C0558252', 'cui_str': 'Emergency contraception'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",1360.0,0.16327,"Intervention participants had higher rates of sexual activity at baseline, more of their recruitment visits were for pregnancy testing, emergency contraception or birth control, and they had lower completion rates of follow-up surveys than controls.","[{'ForeName': 'Kathleen P', 'Initials': 'KP', 'LastName': 'Tebb', 'Affiliation': 'Department of Pediatrics, University of California San Francisco, CA, USA. Electronic address: Kathleen.tebb@ucsf.edu.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Pediatrics, University of California San Francisco, CA, USA.'}, {'ForeName': 'Lance M', 'Initials': 'LM', 'LastName': 'Pollack', 'Affiliation': 'Department of Pediatrics, University of California San Francisco, CA, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Adams', 'Affiliation': 'Department of Pediatrics, University of California San Francisco, CA, USA.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Rico', 'Affiliation': ""The Los Angeles Trust for Children's Health, Los Angeles, CA, USA.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Renteria', 'Affiliation': ""The Los Angeles Trust for Children's Health, Los Angeles, CA, USA.""}, {'ForeName': 'Sang Leng', 'Initials': 'SL', 'LastName': 'Trieu', 'Affiliation': ""The Los Angeles Trust for Children's Health, Los Angeles, CA, USA.""}, {'ForeName': 'Loris', 'Initials': 'L', 'LastName': 'Hwang', 'Affiliation': 'Medical Center, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Claire D', 'Initials': 'CD', 'LastName': 'Brindis', 'Affiliation': 'Department of Pediatrics and the Philip R. Lee Institute for Health Policy Studies, University of California San Francisco, Los Angeles, CA, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ozer', 'Affiliation': 'Department of Pediatrics and the Office for Diversity and Outreach, University of California San Francisco, Los Angeles, CA, USA.'}, {'ForeName': 'Maryjane', 'Initials': 'M', 'LastName': 'Puffer', 'Affiliation': ""The Los Angeles Trust for Children's Health, Los Angeles, CA, USA.""}]",Contraception,['10.1016/j.contraception.2021.03.004'] 2591,33743283,SLC6A4 polymorphisms modulate the efficacy of a tryptophan-enriched diet on age-related depression and social cognition.,"BACKGROUND & AIMS In a placebo controlled study we sought to determine if a four-weeks tryptophan-enriched diet is able to improve age-related depression or social cognitive impairment, depending on polymorphisms located in the promoter region of Solute Carrier Family 6 Member 4 (SLC6A4), also known as serotonin transporter (SERT1) gene. METHODS 91 young volunteers (age: 21 ± 2 yrs) and 127 above 50 years old (58 ± 6 yrs) healthy volunteers completed the study. Participants from the placebo and tryptophan group followed the same protocol. Before starting the study blood samples, to measure serotonin-transporter-linked polymorphic region (5-HTTLPR) and rs25531 polymorphisms, were collected. In addition, before and after completing the study urine samples (to measure 5-hydroxyindolacetic acid (5-HIAA) were taken, while psychological questionnaires (to assess depression and social cognition levels), and a one week dietary record (to calculate the tryptophan (TRP) intake) were assessed. RESULTS The triallelic approach of SLC6A4 showed that in S'S´ subjects there was a positive correlation between TRP intake and 5-HIAA levels. Age of participants, SLC6A4 genotype, and experimental condition were important factors contributing to the outcome of depression and social cognition. CONCLUSIONS 5-HTTLPR and rs25531 polymorphisms play a key role in the response to the TRP- based nutritional intervention, improving only age-related depressive symptoms and empathy in S'S´ subjects who have a higher risk to show signs of depression during their lifetime.",2021,"Age of participants, SLC6A4 genotype, and experimental condition were important factors contributing to the outcome of depression and social cognition. ","['healthy volunteers', '91 young volunteers (age: 21\xa0±\xa02\xa0yrs) and 127 above 50 years old (58\xa0±\xa06\xa0yrs']","['placebo', 'tryptophan-enriched diet', 'placebo and tryptophan']","['TRP intake and 5-HIAA levels', 'tryptophan (TRP) intake']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0020361', 'cui_str': '5-hydroxyindole acetic acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",91.0,0.0537935,"Age of participants, SLC6A4 genotype, and experimental condition were important factors contributing to the outcome of depression and social cognition. ","[{'ForeName': 'Lierni', 'Initials': 'L', 'LastName': 'Ugartemendia', 'Affiliation': 'Department of Physiology, Neuroimmunophysiology and Chrononutrition Research Group, Faculty of Science, University of Extremadura, Badajoz, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Bravo', 'Affiliation': 'Department of Physiology, Neuroimmunophysiology and Chrononutrition Research Group, Faculty of Science, University of Extremadura, Badajoz, Spain. Electronic address: rbravo@unex.es.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reuter', 'Affiliation': 'Biological & Personality Psychology, Laboratory of Neurogenetics, Department of Psychology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'M Yolanda', 'Initials': 'MY', 'LastName': 'Castaño', 'Affiliation': 'Department of Physiology, Neuroimmunophysiology and Chrononutrition Research Group, Faculty of Science, University of Extremadura, Badajoz, Spain.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Plieger', 'Affiliation': 'Biological & Personality Psychology, Laboratory of Neurogenetics, Department of Psychology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Zamoscik', 'Affiliation': 'Department of Clinical Psychology, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kirsch', 'Affiliation': 'Department of Clinical Psychology, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Ana B', 'Initials': 'AB', 'LastName': 'Rodríguez', 'Affiliation': 'Department of Physiology, Neuroimmunophysiology and Chrononutrition Research Group, Faculty of Science, University of Extremadura, Badajoz, Spain.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2021.02.023'] 2592,33743237,"Second intravenous immunoglobulin dose in patients with Guillain-Barré syndrome with poor prognosis (SID-GBS): a double-blind, randomised, placebo-controlled trial.","BACKGROUND Treatment with one standard dose (2 g/kg) of intravenous immunoglobulin is insufficient in a proportion of patients with severe Guillain-Barré syndrome. Worldwide, around 25% of patients severely affected with the syndrome are given a second intravenous immunoglobulin dose (SID), although it has not been proven effective. We aimed to investigate whether a SID is effective in patients with Guillain-Barré syndrome with a predicted poor outcome. METHODS In this randomised, double-blind, placebo-controlled trial (SID-GBS), we included patients (≥12 years) with Guillain-Barré syndrome admitted to one of 59 participating hospitals in the Netherlands. Patients were included on the first day of standard intravenous immunoglobulin treatment (2 g/kg over 5 days). Only patients with a poor prognosis (score of ≥6) according to the modified Erasmus Guillain-Barré syndrome Outcome Score were randomly assigned, via block randomisation stratified by centre, to SID (2 g/kg over 5 days) or to placebo, 7-9 days after inclusion. Patients, outcome adjudicators, monitors, and the steering committee were masked to treatment allocation. The primary outcome measure was the Guillain-Barré syndrome disability score 4 weeks after inclusion. All patients in whom allocated trial medication was started were included in the modified intention-to-treat analysis. This study is registered with the Netherlands Trial Register, NTR 2224/NL2107. FINDINGS Between Feb 16, 2010, and June 5, 2018, 327 of 339 patients assessed for eligibility were included. 112 had a poor prognosis. Of those, 93 patients with a poor prognosis were included in the modified intention-to-treat analysis: 49 (53%) received SID and 44 (47%) received placebo. The adjusted common odds ratio for improvement on the Guillain-Barré syndrome disability score at 4 weeks was 1·4 (95% CI 0·6-3·3; p=0·45). Patients given SID had more serious adverse events (35% vs 16% in the first 30 days), including thromboembolic events, than those in the placebo group. Four patients died in the intervention group (13-24 weeks after randomisation). INTERPRETATION Our study does not provide evidence that patients with Guillain-Barré syndrome with a poor prognosis benefit from a second intravenous immunoglobulin course; moreover, it entails a risk of serious adverse events. Therefore, a second intravenous immunoglobulin course should not be considered for treatment of Guillain-Barre syndrome because of a poor prognosis. The results indicate the need for treatment trials with other immune modulators in patients severely affected by Guillain-Barré syndrome. FUNDING Prinses Beatrix Spierfonds and Sanquin Plasma Products.",2021,"Patients given SID had more serious adverse events (35% vs 16% in the first 30 days), including thromboembolic events, than those in the placebo group.","['patients with severe Guillain-Barré syndrome', 'patients (≥12 years) with Guillain-Barré syndrome admitted to one of 59 participating hospitals in the Netherlands', 'Between Feb 16, 2010, and June 5, 2018', 'Only patients with a poor prognosis (score of ≥6) according to the modified Erasmus Guillain-Barré syndrome Outcome Score', ' 327 of 339 patients assessed for eligibility were included', 'patients severely affected by Guillain-Barré syndrome', 'patients with Guillain-Barré syndrome with a predicted poor outcome', '93 patients with a poor prognosis', 'patients with Guillain-Barré syndrome with poor prognosis (SID-GBS']","['placebo-controlled trial (SID-GBS', 'placebo', 'SID', 'intravenous immunoglobulin', 'standard intravenous immunoglobulin treatment']","['Guillain-Barré syndrome disability score', 'thromboembolic events', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018378', 'cui_str': 'Guillain-Barré syndrome'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0278252', 'cui_str': 'Prognosis bad'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0018378', 'cui_str': 'Guillain-Barré syndrome'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0018378', 'cui_str': 'Guillain-Barré syndrome'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.431843,"Patients given SID had more serious adverse events (35% vs 16% in the first 30 days), including thromboembolic events, than those in the placebo group.","[{'ForeName': 'Christa', 'Initials': 'C', 'LastName': 'Walgaard', 'Affiliation': 'Department of Neurology, Erasmus MC University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Bart C', 'Initials': 'BC', 'LastName': 'Jacobs', 'Affiliation': 'Department of Neurology, Erasmus MC University Medical Center, Rotterdam, Netherlands; Department of Immunology, Erasmus MC University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Hester F', 'Initials': 'HF', 'LastName': 'Lingsma', 'Affiliation': 'Department of Public Health, Erasmus MC University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Ewout W', 'Initials': 'EW', 'LastName': 'Steyerberg', 'Affiliation': 'Department of Public Health, Erasmus MC University Medical Center, Rotterdam, Netherlands; Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'van den Berg', 'Affiliation': 'Department of Neurology, Erasmus MC University Medical Center, Rotterdam, Netherlands; Department of Neurology, Elisabeth-TweeSteden Hospital, Tilburg, Netherlands.'}, {'ForeName': 'Alexandra Y', 'Initials': 'AY', 'LastName': 'Doets', 'Affiliation': 'Department of Neurology, Erasmus MC University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Sonja E', 'Initials': 'SE', 'LastName': 'Leonhard', 'Affiliation': 'Department of Neurology, Erasmus MC University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Verboon', 'Affiliation': 'Department of Neurology, Erasmus MC University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Huizinga', 'Affiliation': 'Department of Immunology, Erasmus MC University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Drenthen', 'Affiliation': 'Department of Neurology, Erasmus MC University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Arends', 'Affiliation': 'Department of Neurology, Erasmus MC University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Ilona Kleine', 'Initials': 'IK', 'LastName': 'Budde', 'Affiliation': 'The Medical Department, Sanquin Plasma Products, Amsterdam, Netherlands.'}, {'ForeName': 'Ruud P', 'Initials': 'RP', 'LastName': 'Kleyweg', 'Affiliation': 'Department of Neurology, Albert Schweitzer Hospital, Dordrecht, Netherlands.'}, {'ForeName': 'Krista', 'Initials': 'K', 'LastName': 'Kuitwaard', 'Affiliation': 'Department of Neurology, Erasmus MC University Medical Center, Rotterdam, Netherlands; Department of Neurology, Albert Schweitzer Hospital, Dordrecht, Netherlands.'}, {'ForeName': 'Marjon F G', 'Initials': 'MFG', 'LastName': 'van der Meulen', 'Affiliation': 'Department of Neurology, Sint Antonius Hospital, Nieuwegein, Netherlands.'}, {'ForeName': 'Johnny P A', 'Initials': 'JPA', 'LastName': 'Samijn', 'Affiliation': 'Department of Neurology, Maasstad Hospital, Rotterdam, Netherlands.'}, {'ForeName': 'Frederique H', 'Initials': 'FH', 'LastName': 'Vermeij', 'Affiliation': 'Department of Neurology, Franciscus en Vlietland Hospital, Rotterdam, Netherlands.'}, {'ForeName': 'Jan B M', 'Initials': 'JBM', 'LastName': 'Kuks', 'Affiliation': 'Department of Neurology, University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'Gert W', 'Initials': 'GW', 'LastName': 'van Dijk', 'Affiliation': 'Department of Neurology, Canisius Wilhelmina Hospital, Nijmegen, Netherlands.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Wirtz', 'Affiliation': 'Department of Neurology, Haga Hospital, Den Haag, Netherlands.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Eftimov', 'Affiliation': 'Department of Neurology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Anneke J', 'Initials': 'AJ', 'LastName': 'van der Kooi', 'Affiliation': 'Department of Neurology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Marcel P J', 'Initials': 'MPJ', 'LastName': 'Garssen', 'Affiliation': 'Department of Neurology, Jeroen Bosch hospital, Den Bosch, Netherlands.'}, {'ForeName': 'Cees J', 'Initials': 'CJ', 'LastName': 'Gijsbers', 'Affiliation': 'Department of Neurology, Franciscus en Vlietland Hospital, Rotterdam, Netherlands.'}, {'ForeName': 'Maarten C', 'Initials': 'MC', 'LastName': 'de Rijk', 'Affiliation': 'Department of Neurology, Catharina Hospital, Eindhoven, Netherlands.'}, {'ForeName': 'Leo H', 'Initials': 'LH', 'LastName': 'Visser', 'Affiliation': 'Department of Neurology, Elisabeth-TweeSteden Hospital, Tilburg, Netherlands.'}, {'ForeName': 'Roderik J', 'Initials': 'RJ', 'LastName': 'Blom', 'Affiliation': 'Department of Neurology, Diakonessenhuis, Utrecht, Netherlands.'}, {'ForeName': 'Wim H J P', 'Initials': 'WHJP', 'LastName': 'Linssen', 'Affiliation': 'Department of Neurology, Onze Lieve Vrouwen Gasthuis-West, Amsterdam, Netherlands; Zaans Medical Center, Zaandam, Netherlands.'}, {'ForeName': 'Elly L', 'Initials': 'EL', 'LastName': 'van der Kooi', 'Affiliation': 'Department of Neurology, Leeuwarden Medical Center, Leeuwarden, Netherlands.'}, {'ForeName': 'Jan J G M', 'Initials': 'JJGM', 'LastName': 'Verschuuren', 'Affiliation': 'Department of Neurology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Rinske', 'Initials': 'R', 'LastName': 'van Koningsveld', 'Affiliation': 'Department of Neurology, Elkerliek Hospital, Helmond, Netherlands.'}, {'ForeName': 'Rita J G', 'Initials': 'RJG', 'LastName': 'Dieks', 'Affiliation': 'Department of Neurology, Röpke-Zweers Hospital, Hardenberg, Netherlands.'}, {'ForeName': 'H Job', 'Initials': 'HJ', 'LastName': 'Gilhuis', 'Affiliation': 'Department of Neurology, Reinier de Graaf Hospital, Delft, Netherlands.'}, {'ForeName': 'Korné', 'Initials': 'K', 'LastName': 'Jellema', 'Affiliation': 'Department of Neurology, Haaglanden Medical Center, Den Haag, Netherlands.'}, {'ForeName': 'Taco C', 'Initials': 'TC', 'LastName': 'van der Ree', 'Affiliation': 'Department of Neurology, Dijklander hospital, Hoorn, Netherlands.'}, {'ForeName': 'Henriette M E', 'Initials': 'HME', 'LastName': 'Bienfait', 'Affiliation': 'Department of Neurology, Spaarne Gasthuis, Haarlem, Netherlands.'}, {'ForeName': 'Catharina G', 'Initials': 'CG', 'LastName': 'Faber', 'Affiliation': 'Department of Neurology, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Lovenich', 'Affiliation': 'Department of Neurology, St Jans Hospital, Weert, Netherlands.'}, {'ForeName': 'Baziel G M', 'Initials': 'BGM', 'LastName': 'van Engelen', 'Affiliation': 'Department of Neurology, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Rutger J', 'Initials': 'RJ', 'LastName': 'Groen', 'Affiliation': 'Department of Neurology, Haaglanden Medical Center, Den Haag, Netherlands.'}, {'ForeName': 'Ingemar S J', 'Initials': 'ISJ', 'LastName': 'Merkies', 'Affiliation': 'Department of Neurology, Spaarne Gasthuis, Haarlem, Netherlands; Department of Neurology, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Bob W', 'Initials': 'BW', 'LastName': 'van Oosten', 'Affiliation': 'Department of Neurology, Amsterdam University Medical Centers, VUmc, Amsterdam, Netherlands.'}, {'ForeName': 'W Ludo', 'Initials': 'WL', 'LastName': 'van der Pol', 'Affiliation': 'Department of Neurology, University Medical Center Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Willem D M', 'Initials': 'WDM', 'LastName': 'van der Meulen', 'Affiliation': 'Department of Neurology, Rode Kruis Hospital, Beverwijk, Netherlands.'}, {'ForeName': 'Umesh A', 'Initials': 'UA', 'LastName': 'Badrising', 'Affiliation': 'Department of Neurology, Leiden University Medical Center, Leiden, Netherlands; Department of Neurology, van Weel-Bethesda Hospital, Dirksland, Netherlands.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Stevens', 'Affiliation': 'Department of Neurology, Tergooi Hospitals, Blaricum, Netherlands.'}, {'ForeName': 'Albert-Jan J', 'Initials': 'AJ', 'LastName': 'Breukelman', 'Affiliation': 'Department of Neurology, ZorgSaam Hospital, Terneuzen, Netherlands.'}, {'ForeName': 'Casper P', 'Initials': 'CP', 'LastName': 'Zwetsloot', 'Affiliation': 'Department of Neurology, Dijklander Hospital, Purmerend, Netherlands.'}, {'ForeName': 'Maaike M', 'Initials': 'MM', 'LastName': 'van der Graaff', 'Affiliation': 'Department of Neurology, BovenIJ Hospital, Amsterdam, Netherlands.'}, {'ForeName': 'Marielle', 'Initials': 'M', 'LastName': 'Wohlgemuth', 'Affiliation': 'Department of Neurology, Elisabeth-TweeSteden Hospital, Tilburg, Netherlands.'}, {'ForeName': 'Richard A C', 'Initials': 'RAC', 'LastName': 'Hughes', 'Affiliation': 'MRC Centre for Neuromuscular Diseases, National Hospital for Neurology and Neurosurgery, London, UK.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Cornblath', 'Affiliation': 'Department of Neurology, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Pieter A', 'Initials': 'PA', 'LastName': 'van Doorn', 'Affiliation': 'Department of Neurology, Erasmus MC University Medical Center, Rotterdam, Netherlands. Electronic address: p.a.vandoorn@erasmusmc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30494-4'] 2593,33743100,Optimization of contrast medium volume for abdominal CT in oncologic patients: prospective comparison between fixed and lean body weight-adapted dosing protocols.,"BACKGROUND Patient body size represents the main determinant of parenchymal enhancement and by adjusting the contrast media (CM) dose to patient weight may be a more appropriate approach to avoid a patient over dosage of CM. To compare the performance of fixed-dose and lean body weight (LBW)-adapted contrast media dosing protocols, in terms of image quality and parenchymal enhancement. RESULTS One-hundred cancer patients undergoing multiphasic abdominal CT were prospectively enrolled in this multicentric study and randomly divided in two groups: patients in fixed-dose group (n = 50) received 120 mL of CM while in LBW group (n = 50) the amount of CM was computed according to the patient's LBW. LBW protocol group received a significantly lower amount of CM (103.47 ± 17.65 mL vs. 120.00 ± 0.00 mL, p < 0.001). Arterial kidney signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) and pancreatic CNR were significantly higher in LBW group (all p ≤ 0.004). LBW group provided significantly higher arterial liver, kidney, and pancreatic contrast enhancement index (CEI) and portal venous phase kidney CEI (all p ≤ 0.002). Significantly lower portal vein SNR and CNR were observed in LBW-Group (all p ≤ 0.020). CONCLUSIONS LBW-adapted CM administration for abdominal CT reduces the volume of injected CM and improves both image quality and parenchymal enhancement.",2021,"Significantly lower portal vein SNR and CNR were observed in LBW-Group (all p ≤ 0.020). ","['oncologic patients', 'One-hundred cancer patients undergoing multiphasic abdominal CT']","['LBW', '120\xa0mL of CM while in LBW']","['Arterial kidney signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) and pancreatic CNR', 'image quality and parenchymal enhancement', 'arterial liver, kidney, and pancreatic contrast enhancement index (CEI) and portal venous phase kidney CEI', 'amount of CM', 'portal vein SNR and CNR']","[{'cui': 'C0205478', 'cui_str': 'Oncologic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}]","[{'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0032718', 'cui_str': 'Portal vein structure'}]",100.0,0.0178957,"Significantly lower portal vein SNR and CNR were observed in LBW-Group (all p ≤ 0.020). ","[{'ForeName': 'Damiano', 'Initials': 'D', 'LastName': 'Caruso', 'Affiliation': ""Radiology Unit, Department of Surgical and Medical Sciences and Translational Medicine, Sapienza University of Rome - Sant'Andrea University Hospital, Via di Grottarossa, 1035-1039, 00189, Rome, Italy.""}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Rosati', 'Affiliation': ""Radiology Unit, Department of Surgical and Medical Sciences and Translational Medicine, Sapienza University of Rome - Sant'Andrea University Hospital, Via di Grottarossa, 1035-1039, 00189, Rome, Italy.""}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Panvini', 'Affiliation': 'Diagnostic Imaging Unit, Department of Medico-Surgical Sciences and Biotechnologies, ICOT Hospital, ""Sapienza"" University of Rome, Via Franco Faggiana, 1668, 04100, Latina, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Rengo', 'Affiliation': 'Diagnostic Imaging Unit, Department of Medico-Surgical Sciences and Biotechnologies, ICOT Hospital, ""Sapienza"" University of Rome, Via Franco Faggiana, 1668, 04100, Latina, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Bellini', 'Affiliation': 'Diagnostic Imaging Unit, Department of Medico-Surgical Sciences and Biotechnologies, ICOT Hospital, ""Sapienza"" University of Rome, Via Franco Faggiana, 1668, 04100, Latina, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Moltoni', 'Affiliation': ""Radiology Unit, Department of Surgical and Medical Sciences and Translational Medicine, Sapienza University of Rome - Sant'Andrea University Hospital, Via di Grottarossa, 1035-1039, 00189, Rome, Italy.""}, {'ForeName': 'Benedetta', 'Initials': 'B', 'LastName': 'Bracci', 'Affiliation': ""Radiology Unit, Department of Surgical and Medical Sciences and Translational Medicine, Sapienza University of Rome - Sant'Andrea University Hospital, Via di Grottarossa, 1035-1039, 00189, Rome, Italy.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Lucertini', 'Affiliation': ""Radiology Unit, Department of Surgical and Medical Sciences and Translational Medicine, Sapienza University of Rome - Sant'Andrea University Hospital, Via di Grottarossa, 1035-1039, 00189, Rome, Italy.""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Zerunian', 'Affiliation': ""Radiology Unit, Department of Surgical and Medical Sciences and Translational Medicine, Sapienza University of Rome - Sant'Andrea University Hospital, Via di Grottarossa, 1035-1039, 00189, Rome, Italy.""}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Polici', 'Affiliation': ""Radiology Unit, Department of Surgical and Medical Sciences and Translational Medicine, Sapienza University of Rome - Sant'Andrea University Hospital, Via di Grottarossa, 1035-1039, 00189, Rome, Italy.""}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'De Santis', 'Affiliation': ""Radiology Unit, Department of Surgical and Medical Sciences and Translational Medicine, Sapienza University of Rome - Sant'Andrea University Hospital, Via di Grottarossa, 1035-1039, 00189, Rome, Italy.""}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Iannicelli', 'Affiliation': ""Radiology Unit, Department of Surgical and Medical Sciences and Translational Medicine, Sapienza University of Rome - Sant'Andrea University Hospital, Via di Grottarossa, 1035-1039, 00189, Rome, Italy.""}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Anibaldi', 'Affiliation': ""Hospital Direction and Clinical Departments, Sant'Andrea University Hospital, Via di Grottarossa, 1035-1039, 00189, Rome, Italy.""}, {'ForeName': 'Iacopo', 'Initials': 'I', 'LastName': 'Carbone', 'Affiliation': 'Diagnostic Imaging Unit, Department of Medico-Surgical Sciences and Biotechnologies, ICOT Hospital, ""Sapienza"" University of Rome, Via Franco Faggiana, 1668, 04100, Latina, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Laghi', 'Affiliation': ""Radiology Unit, Department of Surgical and Medical Sciences and Translational Medicine, Sapienza University of Rome - Sant'Andrea University Hospital, Via di Grottarossa, 1035-1039, 00189, Rome, Italy. andrea.laghi@uniroma1.it.""}]",Insights into imaging,['10.1186/s13244-021-00980-0'] 2594,33749913,Regression of human coronary artery plaque is associated with a high ratio of (18-hydroxy-eicosapentaenoic acid + resolvin E1) to leukotriene B 4 .,"Inflammation in arterial walls leads to coronary artery disease (CAD). We previously reported that a high omega-3 fatty index was associated with prevention of progression of coronary atherosclerosis, a disease of chronic inflammation in the arterial wall. However, the mechanism of such benefit is unclear. The two main omega-3 fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), are precursors of specialized pro-resolving lipid mediators (SPMs)-resolvins and maresins-which actively resolve chronic inflammation. To explore whether SPMs are associated with coronary plaque progression, levels of SPMs and proinflammatory mediators (leukotriene B 4 [LTB 4 ] and prostaglandins) were measured using liquid chromatography-tandem mass spectrometry in 31 statin-treated patients with stable CAD randomized to either EPA and DHA, 3.36 g daily, or no EPA/DHA (control). Coronary plaque volume was measured by coronary computed tomographic angiography at baseline and at 30-month follow-up. Higher plasma levels of EPA+DHA were associated with significantly increased levels of two SPMs-resolvin E1 and maresin 1-and 18-hydroxy-eicosapentaenoic acid (HEPE), the precursor of resolvin E1. Those with low plasma EPA+DHA levels had a low (18-HEPE+resolvin E1)/LTB 4 ratio and significant plaque progression. Those with high plasma EPA+DHA levels had either low (18-HEPE+resolvin E1)/LTB 4 ratios with significant plaque progression or high (18-HEPE+resolvin E1)/LTB 4 ratios with significant plaque regression. These findings suggest that an imbalance between pro-resolving and proinflammatory lipid mediators is associated with plaque progression and potentially mediates the beneficial effects of EPA and DHA in CAD patients.",2021,"Higher plasma levels of EPA+DHA were associated with significantly increased levels of two SPMs-resolvin E1 and maresin 1-and 18-hydroxy-eicosapentaenoic acid (HEPE), the precursor of resolvin E1.",[],"['omega-3 fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA', 'EPA and DHA, 3.36 g daily, or no EPA/DHA (control']",['Coronary plaque volume'],[],"[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",31.0,0.151671,"Higher plasma levels of EPA+DHA were associated with significantly increased levels of two SPMs-resolvin E1 and maresin 1-and 18-hydroxy-eicosapentaenoic acid (HEPE), the precursor of resolvin E1.","[{'ForeName': 'Francine K', 'Initials': 'FK', 'LastName': 'Welty', 'Affiliation': 'Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Schulte', 'Affiliation': 'The Forsyth Institute, Cambridge, MA, USA.'}, {'ForeName': 'Abdulhamied', 'Initials': 'A', 'LastName': 'Alfaddagh', 'Affiliation': 'Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Tarec K', 'Initials': 'TK', 'LastName': 'Elajami', 'Affiliation': 'Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Bistrian', 'Affiliation': 'Department of Internal Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Hardt', 'Affiliation': 'The Forsyth Institute, Cambridge, MA, USA.'}]",FASEB journal : official publication of the Federation of American Societies for Experimental Biology,['10.1096/fj.202002471R'] 2595,33749328,Effect of Web-Based Time-Use Intervention on Occupational Balance During the Covid-19 Pandemic.,"BACKGROUND. Restrictions implemented to control the spread of the Covid-19 pandemic may lead to disruptions in occupational balance among university students. PURPOSE. The aim of this study was to evaluate the effectiveness of a web-based time-use intervention on the occupational balance of university students. METHOD. A total of 60 participants were randomly assigned to the intervention and control groups. The intervention group received eight sessions of web-based time management intervention, while the control group received a single-session web-based time management intervention. Pre-and post-intervention occupational balance of the participants was evaluated with Occupational Balance Questionnaire (OBQ). FINDINGS. The eight-session intervention was more effective than the single-session intervention in improving OBQ total scores and all individual OBQ item scores except for ""Having sufficient things to do during a regular week."" IMPLICATIONS. Occupational therapists can implement web-based time management interventions to promote the occupational balance of university students during the Covid-19 pandemic.",2021,"The eight-session intervention was more effective than the single-session intervention in improving OBQ total scores and all individual OBQ item scores except for ""Having sufficient things to do during a regular week."" ","['60 participants', 'university students', 'university students during the Covid-19 pandemic']","['web-based time-use intervention', 'eight sessions of web-based time management intervention, while the control group received a single-session web-based time management intervention']","['occupational balance', 'Occupational Balance Questionnaire (OBQ', 'OBQ total scores and all individual OBQ item scores']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0206209', 'cui_str': 'Time Management'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0559741', 'cui_str': 'Item score'}]",60.0,0.00531271,"The eight-session intervention was more effective than the single-session intervention in improving OBQ total scores and all individual OBQ item scores except for ""Having sufficient things to do during a regular week."" ","[{'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Pekçetin', 'Affiliation': ''}, {'ForeName': 'Ayla', 'Initials': 'A', 'LastName': 'Günal', 'Affiliation': ''}]",Canadian journal of occupational therapy. Revue canadienne d'ergotherapie,['10.1177/0008417421994967'] 2596,33748923,Patient's perception of recovery after osteotome-mediated sinus floor elevation with Bio-Oss collagen compared with no grafting material: a randomized single-blinded controlled trial.,"BACKGROUND Osteotome-mediated sinus floor elevation with or without a grafting material is associated with high implant survival, intrasinus bone gain, and low frequency of complications. However, patient's perception of recovery and satisfaction with the surgical intervention are rarely reported. The objective of the present randomized controlled trial was to assess patient's perception of recovery after osteotome-mediated sinus floor elevation with Bio-Oss collagen compared with no grafting material. Forty healthy patients were randomly allocated to Bio-Oss collagen or no grafting material. Oral health-related quality of life was assessed by Oral Health Impact Profile-14 at enrollment. Patient's perception of recovery was assessed by self-administrated questionnaires and visual analog scale evaluating pain, social and working isolation, physical appearance, duration and quality of life alterations, eating and speaking ability, diet variations, and sleep impairment after 1 week and 1 month, respectively. Descriptive statistics was expressed as mean percentage with standard deviation. Correlation between impaired oral health-related quality of life, age, gender, and recovery were assessed by T test. Level of significance was 0.05. RESULTS Osteotome-mediated sinus floor elevation is associated with high patient satisfaction, limited postoperative discomfort, and willingness to undergo similar surgery. Influence on patient's daily life activities seems to be minimal and limited to the first postoperative days. Most patients managed to return to work and their routine daily activities after 0-2 days. Impaired preoperative oral health-related quality of life, gender, or younger age seems not to predispose for delayed recovery. However, number of days with pain, eating difficulties, and sleep disturbances were significantly increased with Bio-Oss collagen compared with no grafting material (P<0.05). CONCLUSION Patient's discomfort seems to be minimal and limited to the first postoperative days following osteotome-mediated sinus floor elevation with or without a grafting material. Impaired preoperative oral health-related quality of life, gender, or younger age seems not to predispose for delayed recovery.",2021,"Impaired preoperative oral health-related quality of life, gender, or younger age seems not to predispose for delayed recovery.",['Forty healthy patients'],"['no grafting material', 'Bio-Oss collagen or no grafting material', 'osteotome-mediated sinus floor elevation with Bio-Oss collagen compared with no grafting material']","['number of days with pain, eating difficulties, and sleep disturbances', 'Oral health-related quality of life', 'self-administrated questionnaires and visual analog scale evaluating pain, social and working isolation, physical appearance, duration and quality of life alterations, eating and speaking ability, diet variations, and sleep impairment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0174021', 'cui_str': 'Bio-Oss'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0182092', 'cui_str': 'Osteotome'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518085', 'cui_str': 'Difficulty eating'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0750731', 'cui_str': 'Body, Physical Appearance'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",40.0,0.0851797,"Impaired preoperative oral health-related quality of life, gender, or younger age seems not to predispose for delayed recovery.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Starch-Jensen', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Aalborg University Hospital, 18-22 Hobrovej, DK-9000, Aalborg, Denmark. thomas.jensen@rn.dk.'}, {'ForeName': 'Niels Henrik', 'Initials': 'NH', 'LastName': 'Bruun', 'Affiliation': 'Unit of Clinical Biostatistics, Aalborg University Hospital, Aalborg, Denmark.'}]",International journal of implant dentistry,['10.1186/s40729-021-00302-5'] 2597,33757813,Effects of high-intensity interval training combined with traditional strength or power training on functionality and physical fitness in healthy older men: A randomized controlled trial.,"Concurrent training (CT) is an efficient strategy to improve neuromuscular function and cardiorespiratory fitness in older adults, which are factors of pivotal importance for the maintenance of functional capacity with aging. However, there is a lack of evidence about the effectiveness of power training (PT) as an alternative to traditional strength training (TST) during CT. Thus, the aim of the present study was to examine the effect of 16 weeks (twice weekly) TST combined with high intensity interval training (TST + HIIT) vs. PT combined with HIIT (PT + HIIT) on functional performance, cardiorespiratory fitness and body composition in older men. Thirty five older men (65.8 ± 3.9 years) were randomly allocated into two training groups: TST + HIIT (n = 18), and PT + HIIT (n = 17). TST + HIIT performed resistance training at intensities ranging from 65% to 80% 1RM at slow controlled speed (≅ 2 s for each concentric phase), whereas PT + HIIT trained at intensities ranging from 40% to 60% of 1RM at maximal intentional speed. Both groups performed HIIT at intensities ranging from 75 to 90% of VO 2peak . Participants performed functional tests (sit-to-stand, timed-up-and-go, stair climbing); cardiopulmonary exercise testing (maximal cycling power output: W max , peak oxygen uptake: VO 2peak , cycling economy), as well as body composition assessment (DXA) before, post 8 and post 16 weeks of training. The groups improved similarly (P < 0.05) with training in all functional capacity outcomes, W max , cycling economy, VO 2peak and body composition (P < 0.05). These findings suggest that HIIT based CT programs involving TST vs. PT are equally effective in improving functionality, cardiorespiratory fitness and body composition in healthy older men.",2021,"The groups improved similarly (P < 0.05) with training in all functional capacity outcomes, W max , cycling economy, VO 2peak and body composition (P < 0.05).","['healthy older men', 'Thirty five older men (65.8\u202f±\u202f3.9\u202fyears', 'older adults', 'older men']","['TST combined with high intensity interval training (TST\u202f+\u202fHIIT) vs. PT combined with HIIT (PT\u202f+\u202fHIIT', 'high-intensity interval training combined with traditional strength or power training', 'functional tests (sit-to-stand, timed-up-and-go, stair climbing); cardiopulmonary exercise testing (maximal cycling power output: W max , peak oxygen uptake: VO 2peak , cycling economy), as well as body composition assessment (DXA', 'Concurrent training (CT', 'TST\u202f+\u202fHIIT performed resistance training', 'TST\u202f+\u202fHIIT', 'power training (PT']","['functionality and physical fitness', 'functionality, cardiorespiratory fitness and body composition', 'functional capacity outcomes, W max , cycling economy, VO 2peak and body composition', 'functional performance, cardiorespiratory fitness and body composition']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C1290942', 'cui_str': 'Climbing stairs'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.00914738,"The groups improved similarly (P < 0.05) with training in all functional capacity outcomes, W max , cycling economy, VO 2peak and body composition (P < 0.05).","[{'ForeName': 'Diana Carolina', 'Initials': 'DC', 'LastName': 'Müller', 'Affiliation': 'Exercise Research Laboratory, School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Brazil.'}, {'ForeName': 'Francesco Pinto', 'Initials': 'FP', 'LastName': 'Boeno', 'Affiliation': 'Exercise Research Laboratory, School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Brazil.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IDISNA, Pamplona, Navarra, Spain; CIBER of Frailty and Healthy Aging (CIBERFES), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Aagaard', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, Research Unit for Muscle Physiology and Biomechanics, University of Southern Denmark, Denmark.'}, {'ForeName': 'Juliana Lopes', 'Initials': 'JL', 'LastName': 'Teodoro', 'Affiliation': 'Exercise Research Laboratory, School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Brazil.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Grazioli', 'Affiliation': 'Exercise Research Laboratory, School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Brazil.'}, {'ForeName': 'Giovani', 'Initials': 'G', 'LastName': 'Cunha', 'Affiliation': 'Exercise Research Laboratory, School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Ferrari', 'Affiliation': 'Exercise Research Laboratory, School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Brazil; Postgraduate Program in Cardiology, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Mikel L', 'Initials': 'ML', 'LastName': 'Saez de Asteasu', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IDISNA, Pamplona, Navarra, Spain.'}, {'ForeName': 'Ronei Silveira', 'Initials': 'RS', 'LastName': 'Pinto', 'Affiliation': 'Exercise Research Laboratory, School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Brazil.'}, {'ForeName': 'Eduardo Lusa', 'Initials': 'EL', 'LastName': 'Cadore', 'Affiliation': 'Exercise Research Laboratory, School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Brazil. Electronic address: edu.cadore@ufrgs.br.'}]",Experimental gerontology,['10.1016/j.exger.2021.111321'] 2598,33749317,"A pilot study of the effects of losartan vs. placebo on pneumoproteins in HIV: A secondary analysis of a randomized, double blind, study.","Human immunodeficiency virus (HIV) is an independent risk factor for lung disease, including chronic obstructive pulmonary disease (COPD) and emphysema. Angiotensin receptor blockers may be beneficial in COPD and emphysema through pathways that have been implicated in HIV-related lung disease. We performed a randomized comparison of the effects of losartan vs placebo on the plasma concentrations of the pneumoproteins surfactant protein D (SPD) and club cell secretory protein (CCSP) in people living with HIV (PLWH). 108 PLWH were included (52 assigned to losartan and 56 assigned to placebo). We found no difference in the change from baseline in log(2) concentrations of CCSP or SPD over 1 year of follow-up. For SPD, we found a strong interaction by CD4+ counts, where those with CD4+ counts > 350 cells/mm3 treated with losartan had more reduction (improvement) in SPD concentration than those treated with placebo (p-value for interaction < 0.001). In conclusion, we did not find a beneficial effect of losartan on pneumoprotein concentrations in PLWH, but PLWH with higher CD4+ counts may have improvement in SPD when treated with losartan.",2021,We found no difference in the change from baseline in log(2) concentrations of CCSP or SPD over 1 year of follow-up.,"['people living with HIV (PLWH', 'pneumoproteins in HIV', '108 PLWH were included (52 assigned to']","['losartan and 56 assigned to placebo', 'losartan vs. placebo', 'placebo', 'losartan', 'losartan vs placebo', 'Angiotensin receptor blockers']","['log(2) concentrations of CCSP or SPD', 'SPD concentration', 'plasma concentrations of the pneumoproteins surfactant protein D (SPD) and club cell secretory protein (CCSP']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0225668', 'cui_str': 'Clara cell of bronchiole'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0084692', 'cui_str': 'Surfactant Protein D'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",108.0,0.365858,We found no difference in the change from baseline in log(2) concentrations of CCSP or SPD over 1 year of follow-up.,"[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'MacDonald', 'Affiliation': 'University of Minnesota System, 311816, 401 East River Parkway, Minneapolis, Minnesota, United States, 55455-2020; macdo147@umn.edu.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Collins', 'Affiliation': 'University of Minnesota System, 311816, Department of Biostatistics, Minneapolis, Minnesota, United States; gary-c@ccbr.umn.edu.'}, {'ForeName': 'Chris H', 'Initials': 'CH', 'LastName': 'Wendt', 'Affiliation': 'Minneapolis VA Health Care System, 20040, Pulmonary Section, Minneapolis, Minnesota, United States; wendt005@umn.edu.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Wolfson', 'Affiliation': 'University of Minnesota System, 311816, Department of Biostatistics , Minneapolis, Minnesota, United States; julianw@umn.edu.'}, {'ForeName': 'Russell P', 'Initials': 'RP', 'LastName': 'Tracy', 'Affiliation': 'University of Vermont College of Medicine, Department of Pathology- Colchester Research Facility, Colchester, Vermont, United States; russell.tracy@med.uvm.edu.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Rhame', 'Affiliation': 'Abbott Northwestern Hospital, Division of Infectious Disease, Minneapolis, Minnesota, United States; frankrhame@gmail.com.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Deeks', 'Affiliation': 'University of California, San Francisco, Department of Medicine, Ward 84, Building 80, 995 Potrero Avenue, San Francisco, California, United States, 94110; sdeeks@php.ucsf.edu.'}, {'ForeName': 'Stacey A', 'Initials': 'SA', 'LastName': 'Rizza', 'Affiliation': 'Mayo Clinic, Rochester, United States; rizza.stacey@mayo.edu.'}, {'ForeName': 'Zelalem', 'Initials': 'Z', 'LastName': 'Temesgen', 'Affiliation': 'Mayo Clinic, Rochester, United States; temesgen.zelalem@mayo.edu.'}, {'ForeName': 'Caryn', 'Initials': 'C', 'LastName': 'Morse', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, 35037, Laboratory of Immunoregulation, Bethesda, Maryland, United States; cmorse@wakehealth.edu.'}, {'ForeName': 'Angelike P', 'Initials': 'AP', 'LastName': 'Liappis', 'Affiliation': 'Washington DC VA Medical Center, 19986, Section of Infectious Diseases, Washington, District of Columbia, United States; Angelike.Liappis@va.gov.'}, {'ForeName': 'Irini', 'Initials': 'I', 'LastName': 'Sereti', 'Affiliation': 'National Institutes of Health, 10 Center Drive, Building 10, room 11B07A, Bethesda, Maryland, United States, 20892; isereti@niaid.nih.gov.'}, {'ForeName': 'Jason V', 'Initials': 'JV', 'LastName': 'Baker', 'Affiliation': 'Hennepin Healthcare, 5532, Division of Infectious Diseases, Minneapolis, Minnesota, United States; jason.Baker@hcmed.org.'}, {'ForeName': 'Ken M', 'Initials': 'KM', 'LastName': 'Kunisaki', 'Affiliation': 'Minneapolis VA Health Care System, 20040, Pulmonary Section, Minneapolis, Minnesota, United States; kunis001@umn.edu.'}]",AIDS research and human retroviruses,['10.1089/AID.2020.0285'] 2599,33748418,Effects of Exercise during Weight Loss Maintenance on Appetite Regulation in Women.,"Exercise is accepted as a method to improve weight loss maintenance; however, the mechanisms by which this occurs have yet to be elucidated. In this pilot study, 13 women with obesity underwent a structured weight loss program (goal 8%-10% weight loss) and were then randomized to either a 12-wk diet ( n = 7) or an aerobic exercise training ( n = 6) intervention aimed at maintaining weight loss. At baseline, post-weight loss, and following the weight loss maintenance interventions, measurements of appetite (hunger and satiety) and appetite-regulating hormones (leptin, ghrelin, peptide tyrosine tyrosine, and glucagon-like peptide 1) were obtained after an overnight fast and for 3 h after a standardized test meal. Ad libitum energy intake was measured at a lunch meal. During the weight loss phase, participants lost 9.1% ± 1.1% of baseline body weight. Participants in both groups maintained weight loss during the 12-wk weight loss maintenance intervention. No differences in fasting leptin ( P = 0.68) or in ghrelin ( P = 0.30), peptide tyrosine tyrosine ( P = 0.93), and glucagon-like peptide 1 ( P = 0.98) area under the curve were detected between groups. Similarly, ratings of hunger ( P = 0.99) and satiety ( P = 0.65) area under the curve after the standardized test meal also did not differ between the groups nor did ad libitum energy intake at lunch. In summary, the 12-wk diet and exercise interventions were equally effective at maintaining weight loss in women, and no differences in measures of appetite regulation and food intake were found.",2020,"No differences in fasting leptin ( P = 0.68) or in ghrelin ( P = 0.30), peptide tyrosine tyrosine ( P = 0.93), and glucagon-like peptide 1 ( P = 0.98) area under the curve were detected between groups.","['Women', '13 women with obesity underwent a structured weight loss program (goal 8%-10% weight loss']","['Exercise during Weight Loss Maintenance', 'aerobic exercise training ( n = 6) intervention aimed at maintaining weight loss']","['satiety', 'weight loss maintenance', 'Appetite Regulation', 'appetite regulation and food intake', 'ratings of hunger', 'fasting leptin', 'peptide tyrosine tyrosine', 'weight loss', 'appetite (hunger and satiety) and appetite-regulating hormones (leptin, ghrelin, peptide tyrosine tyrosine, and glucagon-like peptide 1']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}]","[{'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0003622', 'cui_str': 'Appetite control'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0077599', 'cui_str': 'tyrosyltyrosine'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}]",13.0,0.0445363,"No differences in fasting leptin ( P = 0.68) or in ghrelin ( P = 0.30), peptide tyrosine tyrosine ( P = 0.93), and glucagon-like peptide 1 ( P = 0.98) area under the curve were detected between groups.","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Foright', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Metabolism and Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Tanya M', 'Initials': 'TM', 'LastName': 'Halliday', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Metabolism and Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Melanson', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Metabolism and Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Hild', 'Affiliation': 'Anschutz Center for Health and Wellness, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Kristina T', 'Initials': 'KT', 'LastName': 'Legget', 'Affiliation': 'Department of Psychiatry, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Tregellas', 'Affiliation': 'Department of Psychiatry, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Marc-Andre', 'Initials': 'MA', 'LastName': 'Cornier', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Metabolism and Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO.'}]",Translational journal of the American College of Sports Medicine,['10.1249/tjx.0000000000000133'] 2600,33747798,Step-by-step: Feasibility randomised controlled trial of a mobile-based intervention for depression among populations affected by adversity in Lebanon.,"Background E-mental health interventions may help to bridge the mental health treatment gap. Evidence on their effectiveness is compelling in high-income countries. Not enough evidence has been generated on their use with communities affected by adversity in low- and middle-income countries. The World Health Organization (WHO), the National Mental Health Programme (NMMP) at Ministry of Public Health (MoPH) in Lebanon and other partners have adapted a WHO intervention called Step-by-Step for use with Lebanese and displaced people living in Lebanon. Step-by-Step is a minimally guided, internet-based intervention for adults with depression. In this study, a feasibility randomised controlled trial (RCT) and a qualitative process evaluation were conducted to explore the feasibility and the acceptability of the research methods, and the intervention, in preparation for two fully powered trials to assess the effectiveness and cost-effectiveness of Step-by-Step in Lebanon. Method Participants were recruited through social media. Inclusion criteria were: being able to understand and speak Arabic or English; access to an internet connected device; aged over 18; living in Lebanon; scores above cut-off on the Patient Health Questionnaire and the WHO Disability Assessment Schedule 2.0. Participants were randomly assigned to the intervention or enhanced care as usual. They completed post-assessments eight weeks after baseline, and follow-up assessments another three months later. Primary outcomes were depression and level of functioning, secondary outcomes were anxiety, post-traumatic stress, and well-being. Qualitative interviews were conducted to evaluate the feasibility and acceptability of the research procedures and the intervention. Results A total of N  = 138 participants, including 33 Syrians, were recruited and randomised into two equal groups. The dropout rate was higher in the control group (73% post- and 82% follow-up assessment) than in the intervention group (63% post- and 72% follow-up assessment). The intervention was perceived as relevant, acceptable and beneficial to those who completed it. Suggestions were made to further adapt the content and to make the intervention more engaging. Statistical analyses were conducted despite the small sample size. Complete cases analysis showed a statistically significant symptom reduction in depression, anxiety, disability, and post-traumatic stress, and statistically significant improvement in well-being and functioning. Intention-to-treat analysis revealed non-significant effects. Conclusion The research design, methods and procedures are feasible and acceptable in the context of Lebanon and can be applied in the RCTs. Preliminary findings suggest that Step-by-Step may be effective in reducing symptoms of depression and anxiety and improving functioning and well-being.",2021,"Complete cases analysis showed a statistically significant symptom reduction in depression, anxiety, disability, and post-traumatic stress, and statistically significant improvement in well-being and functioning.","['Method\n\n\nParticipants were recruited through social media', 'depression among populations affected by adversity in Lebanon', 'Inclusion criteria were: being able to understand and speak Arabic or English; access to an internet connected device; aged over 18; living in Lebanon; scores above cut-off on the Patient Health Questionnaire and the WHO Disability Assessment Schedule 2.0', 'N \xa0=\xa0138 participants, including 33 Syrians', 'adults with depression']","['mobile-based intervention', 'intervention or enhanced care as usual']","['depression, anxiety, disability, and post-traumatic stress', 'dropout rate', 'effectiveness and cost-effectiveness', 'well-being and functioning', 'depression and level of functioning, secondary outcomes were anxiety, post-traumatic stress, and well-being']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0023190', 'cui_str': 'Lebanon'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0574175', 'cui_str': 'Arabic language'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C4304971', 'cui_str': 'WHODAS (World Health Organization Disability Assessment Schedule) 2.0'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018561', 'cui_str': 'Mesocricetus auratus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",138.0,0.074783,"Complete cases analysis showed a statistically significant symptom reduction in depression, anxiety, disability, and post-traumatic stress, and statistically significant improvement in well-being and functioning.","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Heim', 'Affiliation': 'Department of Psychology, University of Zurich, Switzerland.'}, {'ForeName': 'Jinane Abi', 'Initials': 'JA', 'LastName': 'Ramia', 'Affiliation': 'National Mental Health Programme, Ministry of Public Health, Beirut, Lebanon.'}, {'ForeName': 'Racha Abi', 'Initials': 'RA', 'LastName': 'Hana', 'Affiliation': 'National Mental Health Programme, Ministry of Public Health, Beirut, Lebanon.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Burchert', 'Affiliation': 'Department of Education and Psychology, Freie Universität Berlin, Germany.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Carswell', 'Affiliation': 'Department of Mental Health and Substance Use, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Ilja', 'Initials': 'I', 'LastName': 'Cornelisz', 'Affiliation': 'Amsterdam Center for Learning Analytics, Research Institute, Vrije Universiteit Amsterdam, the Netherlands.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, the Netherlands.'}, {'ForeName': 'Rabih', 'Initials': 'R', 'LastName': 'El Chammay', 'Affiliation': 'National Mental Health Programme, Ministry of Public Health, Beirut, Lebanon.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Noun', 'Affiliation': 'National Mental Health Programme, Ministry of Public Health, Beirut, Lebanon.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'van Klaveren', 'Affiliation': 'Amsterdam Center for Learning Analytics, Research Institute, Vrije Universiteit Amsterdam, the Netherlands.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'van Ommeren', 'Affiliation': 'Department of Mental Health and Substance Use, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Edwina', 'Initials': 'E', 'LastName': 'Zoghbi', 'Affiliation': 'Country Office for Lebanon, World Health Organization, Beirut, Lebanon.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': ""Van't Hof"", 'Affiliation': 'Department of Mental Health and Substance Use, World Health Organization, Geneva, Switzerland.'}]",Internet interventions,['10.1016/j.invent.2021.100380'] 2601,33711671,Influence of BRAF and PIK3CA mutations on the efficacy of FOLFIRI plus bevacizumab or cetuximab as first-line therapy in patients with RAS wild-type metastatic colorectal carcinoma and <3 baseline circulating tumour cells: the randomised phase II VISNÚ-2 study.,"BACKGROUND We explored the influence of BRAF and PIK3CA mutational status on the efficacy of bevacizumab or cetuximab plus 5-fluorouracil/leucovorin and irinotecan (FOLFIRI) as first-line therapy in patients with RAS wild-type metastatic colorectal cancer (mCRC). PATIENTS AND METHODS VISNÚ-2 was a multicentre, randomised, phase II study. Patients with RAS wild-type mCRC and <3 circulating tumour cells/7.5 ml blood were stratified by BRAF/PIK3CA status (wild-type versus mutated) and number of affected organs (1 versus >1), and allocated to bevacizumab (5 mg/kg every 2 weeks) or cetuximab (400 mg/m 2 then 250 mg/m 2 weekly) plus FOLFIRI [irinotecan 180 mg/m 2 , leucovorin 400 mg/m 2 , 5-fluorouracil 400 mg/m 2 (bolus) then 2400 mg/m 2 (46-h continuous infusion) every 2 weeks]. The primary endpoint was progression-free survival (PFS). All analyses were exploratory. RESULTS Two hundred and forty patients with BRAF/PIK3CA wild-type (n = 196) or BRAF- and/or PIK3CA-mutated tumours (n = 44) were enrolled. Median PFS was 12.7 and 8.8 months in patients with BRAF/PIK3CA wild-type and BRAF/PIK3CA-mutated tumours, respectively [hazard ratio (HR) = 1.22; 95% confidence interval (CI) 0.80-1.85; P = 0.3602]. In the BRAF- and/or PIK3CA-mutated cohort, median PFS was 2.8, 8.8 and 15.0 months in patients with BRAF/PI3KCA-mutated (n = 8), BRAF-mutated/PI3KCA wild-type (n = 16) and BRAF wild-type/PI3KCA-mutated (n = 20) tumours, respectively (P = 0.0002). PFS was similar with bevacizumab plus FOLFIRI versus cetuximab plus FOLFIRI in BRAF/PIK3CA wild-type (HR = 0.99; 95% CI 0.67-1.45; P = 0.9486) and BRAF/PIK3CA-mutated tumours (HR = 1.11; 95% CI 0.53-2.35; P = 0.7820). The most common grade 3/4 treatment-related adverse events were neutropenia, diarrhoea and asthenia in both treatment groups. CONCLUSIONS BRAF/PIK3CA status influences outcomes in patients with RAS wild-type mCRC but does not appear to assist with the selection of first-line targeted therapy.",2021,"The most common grade 3/4 treatment-related adverse events were neutropenia, diarrhoea and asthenia in both treatment groups. ","['Two hundred and forty patients with BRAF/PIK3CA wild-type (n\xa0= 196) or BRAF- and/or PIK3CA-mutated tumours (n\xa0= 44) were enrolled', 'patients with RAS wild-type metastatic colorectal cancer (mCRC', 'patients with RAS wild-type mCRC', 'patients with RAS wild-type metastatic colorectal carcinoma and <3 baseline circulating tumour cells', 'Patients with RAS wild-type mCRC and <3 circulating tumour cells/7.5 ml blood']","['FOLFIRI [irinotecan 180 mg/m 2 , leucovorin 400 mg/m 2 , 5-fluorouracil', 'FOLFIRI plus bevacizumab or cetuximab', 'bevacizumab or cetuximab plus 5-fluorouracil/leucovorin and irinotecan (FOLFIRI', 'bevacizumab', 'cetuximab']","['Median PFS', 'neutropenia, diarrhoea and asthenia', 'median PFS', 'PFS', 'progression-free survival (PFS']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C1451005', 'cui_str': 'PIK3CA protein, human'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant'}, {'cui': 'C0005767', 'cui_str': 'Blood'}]","[{'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}]",44.0,0.089367,"The most common grade 3/4 treatment-related adverse events were neutropenia, diarrhoea and asthenia in both treatment groups. ","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sastre', 'Affiliation': 'Medical Oncology, Hospital Clínico San Carlos, Instituto de Investigación Hospital Clínico San Carlos (IdISSC), CIBERONC, Madrid, Spain. Electronic address: jsastrev@salud.madrid.org.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'García-Alfonso', 'Affiliation': 'Medical Oncology, Hospital Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Viéitez', 'Affiliation': 'Medical Oncology, Hospital Universitario Central de Asturias, Oviedo, Spain.'}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Cano', 'Affiliation': 'Medical Oncology, IMIBIC, Reina Sofía Hospital, University of Córdoba, CIBERONC, Instituto de Salud Carlos III, Cordoba, Spain.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Rivera', 'Affiliation': 'Medical Oncology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Reina-Zoilo', 'Affiliation': 'Medical Oncology, Complejo Hospitalario Virgen de la Macarena, Seville, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Salud-Salvia', 'Affiliation': 'Hospital Universitario Arnau de Vilanova de Lleida, Lleida, Spain.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Quintero', 'Affiliation': 'Medical Oncology, Hospital Lucus Augusti, Lugo, Spain.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Robles-Díaz', 'Affiliation': 'Medical Oncology, Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Safont', 'Affiliation': 'Medical Oncology, Hospital General Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'La Casta', 'Affiliation': 'Medical Oncology, Hospital de Donostia, Guipúzcoa, Spain.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gil', 'Affiliation': 'Medical Oncology, Hospital Universitario Regional y Virgen de la Victoria, Malaga, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Polo', 'Affiliation': 'Medical Oncology, Hospital Miguel Servet, Zaragoza, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Asensio-Martínez', 'Affiliation': 'Medical Oncology, Hospital General Universitario de Elche, Alicante, Spain.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'García-Paredes', 'Affiliation': 'Medical Oncology, Hospital Clínico San Carlos, Instituto de Investigación Hospital Clínico San Carlos (IdISSC), CIBERONC, Madrid, Spain.'}, {'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'López', 'Affiliation': 'Medical Oncology, University Clinical Hospital and Health Research Institute (IDIS), CIBERONC, Santiago de Compostela University School of Medicine, Santiago de Compostela, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Guillot', 'Affiliation': 'Medical Oncology, Hospital Son Espases, Palma de Mallorca, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Valladares-Ayerbes', 'Affiliation': 'Medical Oncology, Complejo Hospitalario Universitario A Coruña, Instituto de Investigación Biomédica (INIBIC), A Coruña, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Aranda', 'Affiliation': 'Medical Oncology, IMIBIC, Reina Sofía Hospital, University of Córdoba, CIBERONC, Instituto de Salud Carlos III, Cordoba, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Díaz-Rubio', 'Affiliation': 'Medical Oncology, Hospital Clínico San Carlos, Instituto de Investigación Hospital Clínico San Carlos (IdISSC), CIBERONC, Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",ESMO open,['10.1016/j.esmoop.2021.100062'] 2602,33753319,Effectiveness of Bilateral Ultrasound-Guided Erector Spinae Plane Block in Percutaneous Lumbar Osteosynthesis for Spine Trauma: A Retrospective Study.,"BACKGROUND Postoperative pain in spine surgery is an issue. Erector spinae plane block (ESPB) may reduce such postoperative pain, but its usefulness has never been evaluated in the specific context of trauma surgery. We thus studied the effect of bilateral ultrasound-guided ESPB on postoperative pain and opioid requirement after percutaneous lumbar arthrodesis for trauma. METHODS All patients who underwent percutaneous lumbar arthrodesis for spine trauma between December 2019 and March 2020 were retrospectively studied. Some patients received preoperative bilateral ESPB (30 mL of 0.375% ropivacaine on each side; ESPB group), others received the standard of care (i.e., postoperative muscular infiltration with 30 mL of 0.75% of ropivacaine; control group), according to the preference of the anesthesiologist in charge of the patient. The rest of the management was identical in all patients. The primary outcome was the cumulative morphine consumption at 24 hours postoperatively. Secondary outcomes included pain score at various time points until 24 hours. RESULTS Fifty-five patients were included, of whom 24 received an EPSB and 31 received the standard of care. The cumulative morphine consumption (mean [standard deviation]) at 24 hours was 13 (12) mg in the ESPB group, and 35 (17) mg in the control group (P < 0.001). Pain scores were significantly lower in the ESPB group compared with the control group up to 9 hours after surgery (P < 0.01). CONCLUSIONS In this pilot study, compared with standard analgesia, ESPB reduced opioid requirement and postoperative pain after percutaneous lumbar arthrodesis for trauma. A randomized controlled trial is required to prove this effectiveness.",2021,"Pain scores were significantly lower in the ESPB group compared with the control group up to 9 hours after surgery (p<0.01). ","['All patients who underwent percutaneous lumbar arthrodesis for spine trauma between December 2019 and March 2020 were retrospectively studied', 'percutaneous lumbar arthrodesis for trauma', 'after percutaneous lumbar arthrodesis for trauma', 'Percutaneous Lumbar Osteosynthesis For Spine Trauma', '55 patients were included, of whom 24 received an EPSB and 31 standard of care']","['Erector Spinae Plane Block (ESPB', 'standard analgesia, ESPB', 'ESPB', 'bilateral ultrasound-guided ESPB', 'ropivacaine', 'Bilateral Ultrasound-Guided Erector Spinae Plane Block', 'preoperative bilateral ESPB']","['Pain scores', 'opioid requirement and postoperative pain', 'pain score at various time points until 24 hours', 'cumulative morphine consumption', 'postoperative pain and opioid requirement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0186045', 'cui_str': 'Lumbar spinal fusion'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",55.0,0.104875,"Pain scores were significantly lower in the ESPB group compared with the control group up to 9 hours after surgery (p<0.01). ","[{'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Cirenei', 'Affiliation': ""Department of Anaesthesia and Intensive Care, CHU de Lille, Pôle d'Anesthésie Réanimation, Lille, France. Electronic address: cedric.cirenei@chru-lille.fr.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Boussemart', 'Affiliation': ""Department of Anaesthesia and Intensive Care, CHU de Lille, Pôle d'Anesthésie Réanimation, Lille, France.""}, {'ForeName': 'Henri-Arthur', 'Initials': 'HA', 'LastName': 'Leroy', 'Affiliation': 'Department of Neurosurgery, CHU de Lille, Lille, France.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Assaker', 'Affiliation': 'Department of Neurosurgery, CHU de Lille, Lille, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Tavernier', 'Affiliation': ""Department of Anaesthesia and Intensive Care, CHU de Lille, Pôle d'Anesthésie Réanimation, Lille, France.""}]",World neurosurgery,['10.1016/j.wneu.2021.03.068'] 2603,33753147,"Safety, tolerability, pharmacokinetics, and food effect of baicalein tablets in healthy Chinese subjects: A single-center, randomized, double-blind, placebo-controlled, single-dose phase I study.","ETHNOPHARMACOLOGICAL RELEVANCE Scutellaria baicalensis (Huang-Qin in Chinese) is a dry root of the perennial herb Scutellaria baicalensis Georgi, which has been used extensively in current prescriptions. Scutellaria baicalensis is an herb high in flavonoids, and baicalein is the one flavonoid found in the highest amount in Scutellaria baicalensis. AIM OF THE STUDY Influenza virus could cause mild respiratory tract illness to severe pneumonia and even death. Baicalein has been proved to be one of the effective components against the influenza virus. However, there have been few reports on human trials of baicalein. The purpose of this study was to evaluate the safety of baicalein in vivo and analyze its pharmacokinetic characteristics. MATERIALS AND METHODS Three randomized studies were conducted to evaluate the pharmacokinetics (PK), safety, tolerability, and food effects of baicalein tablets. In the 7-month single-dose safety study, 60 subjects were enrolled and randomized to receive 100-800 mg baicalein tablets or placebo. In the single-dose PK study, 40 subjects were enrolled and randomized to receive 200 mg, 400 mg, 600 mg, 800 mg baicalein tablets. In the study of food effect on PK of baicalein, an additional 10 subjects were enrolled in the 400 mg group, this part of the trial lasted for 7 months. Blood and urine samples for PK analysis were collected at a pre-specified time. PK properties in both fasted and fed states were evaluated, as well as safety and tolerability. RESULTS Among the 80 subjects who were evaluable for the single-dose safety and tolerability, 56 adverse events (AEs) were observed in 32/80 subjects, of which 49 events were from 28/68 subjects in baicalein group and 7 events were from 4/12 subjects in placebo group. All AEs were mild and resolved without any medical intervention. The most common AEs were elevated high-sensitivity C-reactive protein (hs-CRP) level and high triglycerides. After a single administration of baicalein tablets (200 mg, 400 mg, 600 mg, or 800 mg), C max were 280.44, 628.80, 845.20, 489.55 ng/mL; AUC 0-∞ were 2035.57, 2939.31, 4494.88, and 3754.43 h*ng/mL, respectively. And t 1/2z ranged from 7.80 to 14.91 h. The exposure of baicalein and its metabolites increased in a less than dose-proportional manner. CONCLUSION Baicalein tablets within the studied dose range were safe and well-tolerated in healthy Chinese subjects with no serious or severe adverse effects. Further investigation will be needed to assess the safety and efficacy in the target patients.",2021,Baicalein tablets within the studied dose range were safe and well-tolerated in healthy Chinese subjects with no serious or severe adverse effects.,"['10 subjects were enrolled in the 400 mg group, this part of the trial lasted for 7 months', 'healthy Chinese subjects with no serious or severe adverse effects', 'healthy Chinese subjects', '60 subjects', '80 subjects who were evaluable for the single-dose', 'Scutellaria baicalensis (Huang-Qin in Chinese', '40 subjects']","['placebo', '100-800 mg baicalein tablets or placebo', 'baicalein tablets']","['safety and efficacy', 'exposure of baicalein and its metabolites', 'safety and tolerability', 'elevated high-sensitivity C-reactive protein (hs-CRP', 'level and high triglycerides', 'pharmacokinetics (PK), safety, tolerability, and food effects', 'Safety, tolerability, pharmacokinetics, and food effect', 'PK properties', 'safe and well-tolerated', 'safety and tolerability, 56 adverse events (AEs']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1025331', 'cui_str': 'Huangqin'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0052927', 'cui_str': 'baicalein'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0052927', 'cui_str': 'baicalein'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",60.0,0.126063,Baicalein tablets within the studied dose range were safe and well-tolerated in healthy Chinese subjects with no serious or severe adverse effects.,"[{'ForeName': 'Ruihua', 'Initials': 'R', 'LastName': 'Dong', 'Affiliation': 'Beijing Friendship Hospital, Capital Medical University, Beijing, China; Department of Clinical Pharmacology, Affiliated Hospital of Academy of Military Medical Sciences, Beijing, China.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hongzhi', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': 'Department of Clinical Pharmacology, Affiliated Hospital of Academy of Military Medical Sciences, Beijing, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Lou', 'Affiliation': 'Department of Clinical Operations, Clinical Development Division, CSPC ZhongQi Pharmaceutical Technology Co., Ltd, Shijiazhuang, China.'}, {'ForeName': 'Hongmei', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': 'Department of Medicine, Clinical Development Division, CSPC ZhongQi Pharmaceutical Technology Co., Ltd, Shijiazhuang, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Hao', 'Affiliation': 'Department of Biostatistics, Clinical Development Division, CSPC ZhongQi Pharmaceutical Technology Co., Ltd, Shijiazhuang, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': 'Department of Biostatistics, Clinical Development Division, CSPC ZhongQi Pharmaceutical Technology Co., Ltd, Shijiazhuang, China.'}, {'ForeName': 'Zeyuan', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Clinical Pharmacology, Affiliated Hospital of Academy of Military Medical Sciences, Beijing, China. Electronic address: yjxbf9408@126.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2021.114052'] 2604,33753120,A survey of commercially available electronic hand hygiene monitoring systems and their impact on reducing healthcare-associated infections.,"BACKGROUND Although the benefits of electronic hand hygiene monitoring systems (EHHMSs) are well described, uptake has been poor since they were first introduced over 10 years ago. There is considerable published evidence on the association between the introduction of EHHMSs and improved hand hygiene (HH) compliance rates. However, their impact on healthcare-associated infection (HCAI) reduction is much less clear-cut. METHODS Commercial EHHMS identification was undertaken using a Google internet search and all relevant websites and marketing materials were reviewed. A structured literature search was undertaken to identify evidence of HCAI reduction through EHHMS implementation. Structured interviews were undertaken with a number of Directors of Infection Prevention and Control (DIPCs) from acute NHS Trusts in the North West of England to seek opinions on HH improvement strategies and the use of EHHMSs. RESULTS Twenty-nine commercial EHHMSs were identified, 20 of which are currently market active. Six EHHMSs had supporting evidence, across nine published studies, demonstrating their ability to reduce HCAIs. However, most evaluation designs were quasi-experimental with only one study using a high-quality stepped-wedge cluster randomized controlled trial design. In this study the EHHMS was part of a wider HH multi-modal improvement strategy. Structured interviews were undertaken with five DIPCs who consistently expressed a reluctance to support financial investment into this type of technology until EHHMS cost-effectiveness was better established. CONCLUSIONS The evidence base for the ability of EHHMSs to reduce HCAIs needs to improve before NHS trusts will consider procuring them.",2021,"Structured interviews were undertaken with five DIPCs who consistently expressed a reluctance to support financial investment into this type of technology until EHHMS cost-effectiveness was better established. ","['Twenty-nine commercial EHHMSs were identified, 20 of which are currently market active']",['EHHMS'],"['hand hygiene (HH) compliance rates', 'healthcare-associated infection (HCAI) reduction']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1318228', 'cui_str': 'Market'}, {'cui': 'C0205177', 'cui_str': 'Active'}]",[],"[{'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",29.0,0.0795626,"Structured interviews were undertaken with five DIPCs who consistently expressed a reluctance to support financial investment into this type of technology until EHHMS cost-effectiveness was better established. ","[{'ForeName': 'K-R', 'Initials': 'KR', 'LastName': 'Cawthorne', 'Affiliation': ""Department of Innovation Alder Hey Children's NHS Foundation Trust, Liverpool, UK. Electronic address: katierosecawthorne@gmail.com.""}, {'ForeName': 'R P D', 'Initials': 'RPD', 'LastName': 'Cooke', 'Affiliation': ""Department of Innovation Alder Hey Children's NHS Foundation Trust, Liverpool, UK; Department of Medical Microbiology Alder Hey Children's NHS Foundation Trust, Liverpool, UK.""}]",The Journal of hospital infection,['10.1016/j.jhin.2021.03.009'] 2605,33752251,Remote intervention engagement and outcomes in the Clinical Trials in Organ Transplantation in Children consortium multisite trial.,"Remote interventions are increasingly used in transplant medicine but have rarely been rigorously evaluated. We investigated a remote intervention targeting immunosuppressant management in pediatric lung transplant recipients. Patients were recruited from a larger multisite trial if they had a Medication Level Variability Index (MLVI) ≥2.0, indicating worrisome tacrolimus level fluctuation. The manualized intervention included three weekly phone calls and regular follow-up calls. A comparison group included patients who met enrollment criteria after the subprotocol ended. Outcomes were defined before the intent-to-treat analysis. Feasibility was defined as ≥50% of participants completing the weekly calls. MLVI was compared pre- and 180 days postenrollment and between intervention and comparison groups. Of 18 eligible patients, 15 enrolled. Seven additional patients served as the comparison. Seventy-five percent of participants completed ≥3 weekly calls; average time on protocol was 257.7 days. Average intervention group MLVI was significantly lower (indicating improved blood level stability) at 180 days postenrollment (2.9 ± 1.29) compared with pre-enrollment (4.6 ± 2.10), p = .02. At 180 days, MLVI decreased by 1.6 points in the intervention group but increased by 0.6 in the comparison group (p = .054). Participants successfully engaged in a long-term remote intervention, and their medication blood levels stabilized. NCT02266888.",2021,"At 180 days, MLVI decreased by 1.6 points in the intervention group, but increased by 0.6 in the comparison group (p=0.054).","['patients who met enrollment criteria after the sub-protocol ended', 'Patients were recruited from a larger multisite trial if they had a Medication Level Variability Index (MLVI) ≥ 2.0, indicating worrisome tacrolimus level fluctuation', '18 eligible patients, 15 enrolled', 'pediatric lung transplant recipients']","['manualized intervention included 3 weekly phone calls and regular follow-up calls', 'remote intervention targeting immunosuppressant management']","['blood level stability', 'MLVI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0519826', 'cui_str': 'Tacrolimus measurement'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0024128', 'cui_str': 'Transplant of lung'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",18.0,0.0350576,"At 180 days, MLVI decreased by 1.6 points in the intervention group, but increased by 0.6 in the comparison group (p=0.054).","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Duncan-Park', 'Affiliation': ""Department of Pediatrics, Icahn School of Medicine at Mount Sinai, Kravis Children's Hospital, New York, New York, USA.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Dunphy', 'Affiliation': ""Department of Pediatrics, Icahn School of Medicine at Mount Sinai, Kravis Children's Hospital, New York, New York, USA.""}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Becker', 'Affiliation': ""Department of Pediatrics, Icahn School of Medicine at Mount Sinai, Kravis Children's Hospital, New York, New York, USA.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': ""D'Urso"", 'Affiliation': ""Department of Pediatrics, Icahn School of Medicine at Mount Sinai, Kravis Children's Hospital, New York, New York, USA.""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Annunziato', 'Affiliation': ""Department of Pediatrics, Icahn School of Medicine at Mount Sinai, Kravis Children's Hospital, New York, New York, USA.""}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Blatter', 'Affiliation': 'Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Conrad', 'Affiliation': ""Lucille Packard Children's Hospital, Palo Alto, California, USA.""}, {'ForeName': 'Samuel B', 'Initials': 'SB', 'LastName': 'Goldfarb', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Hayes', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}, {'ForeName': 'Ernestina', 'Initials': 'E', 'LastName': 'Melicoff', 'Affiliation': ""Texas Children's Hospital, Houston, Texas, USA.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Schecter', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Visner', 'Affiliation': ""Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Armstrong', 'Affiliation': 'Rho Inc, Durham, North Carolina, USA.'}, {'ForeName': 'Hyunsook', 'Initials': 'H', 'LastName': 'Chin', 'Affiliation': 'Rho Inc, Durham, North Carolina, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Kesler', 'Affiliation': 'Rho Inc, Durham, North Carolina, USA.'}, {'ForeName': 'Nikki M', 'Initials': 'NM', 'LastName': 'Williams', 'Affiliation': 'National Institutes of Health, NIAID, Bethesda, Maryland, USA.'}, {'ForeName': 'Jonah N', 'Initials': 'JN', 'LastName': 'Odim', 'Affiliation': 'National Institutes of Health, NIAID, Bethesda, Maryland, USA.'}, {'ForeName': 'Stuart C', 'Initials': 'SC', 'LastName': 'Sweet', 'Affiliation': 'Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Danziger-Isakov', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Shemesh', 'Affiliation': ""Department of Pediatrics, Icahn School of Medicine at Mount Sinai, Kravis Children's Hospital, New York, New York, USA.""}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.16567'] 2606,33752222,Effects of a Strength-Dominated Exercise Program on Physical Fitness and Cognitive Performance in Preschool Children.,"ABSTRACT Wick, K, Kriemler, S, and Granacher, U. Effects of a strength-dominated exercise program on physical fitness and cognitive performance in preschool children. J Strength Cond Res 35(4): 983-990, 2021-Childhood is characterized by high neuroplasticity that affords qualitative rather than quantitative components of physical activity to maximize the potential to sufficiently develop motor skills and foster long-term engagement in regular physical activity. This study examined the effects of an integrative strength-dominated exercise program on measures of physical fitness and cognitive performance in preschool children. Children aged 4-6 years from 3 kindergartens were randomized into an intervention (INT) group (n = 32) or a control group (n = 22). The 10-week intervention period was conducted 3 times per week (each session lasted 30 minutes) and included exercises for the promotion of muscle strength and power, coordination, and balance. Pre and post training, tests were conducted for the assessment of muscle strength (i.e., handgrip strength), muscle power (i.e., standing long jump), balance (i.e., timed single-leg stand), coordination (hopping on right/left leg), and attentional span (i.e., ""Konzentrations-Handlungsverfahren für Vorschulkinder"" [concentration-action procedure for preschoolers]). Results from 2 × 2 repeated-measures analysis of covariance revealed a significant (p ≤ 0.05) and near significant (p = 0.051) group × time interaction for the standing long jump test and the Konzentrations-Handlungsverfahren. Post hoc tests showed significant pre-post changes for the INT (p < 0.001; d = 1.53) but not the CON (p = 0.72; d = 0.83). Our results indicate that a 10-week strength-dominated exercise program increased jump performance with a concomitant trend toward improvements in attentional capacity of preschool children. Thus, we recommend implementing this type of exercise program for preschoolers.",2021,Post hoc tests showed significant pre-post changes for the INT (p < 0.001; d = 1.53) but not the CON (p = 0.72; d = 0.83).,"['Preschool Children', 'preschool children', 'Children aged 4-6 years from 3 kindergartens']","['Strength-Dominated Exercise Program', 'strength-dominated exercise program', 'integrative strength-dominated exercise program']","['muscle strength (i.e., handgrip strength), muscle power (i.e., standing long jump), balance (i.e., timed single-leg stand), coordination (hopping on right/left leg), and attentional span (i.e., ""Konzentrations-Handlungsverfahren für Vorschulkinder"" [concentration-action procedure for preschoolers', 'Physical Fitness and Cognitive Performance', 'physical fitness and cognitive performance', 'attentional capacity']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0230443', 'cui_str': 'Structure of left lower leg'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}]",,0.00534363,Post hoc tests showed significant pre-post changes for the INT (p < 0.001; d = 1.53) but not the CON (p = 0.72; d = 0.83).,"[{'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Wick', 'Affiliation': 'University of Applied Sciences for Sport and Management Potsdam, Potsdam, Germany.'}, {'ForeName': 'Susi', 'Initials': 'S', 'LastName': 'Kriemler', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Granacher', 'Affiliation': 'Division of Training and Movement Sciences, University of Potsdam, Potsdam, Germany; and.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003942'] 2607,33752164,The effects of sprifermin on symptoms and structure in a subgroup at risk of progression in the FORWARD knee osteoarthritis trial.,"OBJECTIVE To assess pain outcomes and cartilage thickness change in a subgroup at risk (SAR) of further progression in the FORWARD trial of knee osteoarthritis patients treated with sprifermin. METHODS Patients were randomised 1:1:1:1:1 to: sprifermin 100 µg every 6 months (q6mo), 100 µg q12mo, 30 µg q6mo, 30 µg q12mo, or placebo for 18 months. SAR was defined as baseline medial or lateral minimum joint-space width (mJSW) 1.5-3.5 mm and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score 40-90 units. Follow-up to 3 years was included in the analysis. Treatment benefit was explored by repeated measures, linear dose-effect trends by timepoint. RESULTS The SAR comprised 161 (29%) of 549 patients. Mean difference (95% CI) in WOMAC pain at year 3 for sprifermin 100 µg q6mo vs placebo SAR was -8.75 (-22.42, 4.92) for SAR vs 0.97 (-6.22, 8.16) for the intent-to-treat population. SAR placebo patients lost more cartilage over 2 years than the modified ITT (mITT) placebo arm (mean change from baseline, mm [SD]: -0.05 [0.10] vs -0.02 [0.07]). Net total femorotibial joint thickness gain with sprifermin 100 µg q6mo (adjusted mean difference from placebo [95% CI] was similar in the SAR and in the mITT group: 0.06 [0.01, 0.11] vs 0.05 [0.03, 0.07]). CONCLUSIONS Selection for low mJSW and moderate-to-high pain at baseline resulted in more rapid disease progression and demonstrated translation of structure modification (with maintained net benefit on total cartilage thickness) into symptomatic benefit. This subgroup may represent a target population for future trials. CLINICAL TRIAL REGISTRATION NCT01919164.",2021,"SAR placebo patients lost more cartilage over 2 years than the modified ITT (mITT) placebo arm (mean change from baseline, mm [SD]: -0.05 [0.10] vs -0.02 [0.07]).","['Patients', 'knee osteoarthritis patients treated with sprifermin']","['sprifermin', 'SAR placebo', 'sprifermin 100\xa0µg every 6 months (q6mo), 100\xa0µg q12mo, 30\xa0µg q6mo, 30\xa0µg q12mo, or placebo', 'modified ITT (mITT) placebo']","['Net total femorotibial joint thickness gain', 'WOMAC pain', 'SAR', 'pain outcomes and cartilage thickness change']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0585339', 'cui_str': 'Every six months'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]","[{'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",549.0,0.714582,"SAR placebo patients lost more cartilage over 2 years than the modified ITT (mITT) placebo arm (mean change from baseline, mm [SD]: -0.05 [0.10] vs -0.02 [0.07]).","[{'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Guehring', 'Affiliation': 'Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Flavie', 'Initials': 'F', 'LastName': 'Moreau', 'Affiliation': 'EMD Serono Research and Development Institute, Inc., Billerica, MA, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Daelken', 'Affiliation': 'Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Ladel', 'Affiliation': 'Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Guenther', 'Affiliation': 'Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Asger Reinstrup', 'Initials': 'AR', 'LastName': 'Bihlet', 'Affiliation': 'NBCD A/S, Herlev, Denmark.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Wirth', 'Affiliation': 'Chondrometrics GmbH, Ainring, Germany; Department of Imaging and Functional Musculoskeletal Research, Institute of Anatomy & Cell Biology, Paracelsus Medical University Salzburg & Nuremberg, Salzburg, Austria; Ludwig Boltzmann Institute for Arthritis and Rehabilitation, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Eckstein', 'Affiliation': 'Chondrometrics GmbH, Ainring, Germany; Department of Imaging and Functional Musculoskeletal Research, Institute of Anatomy & Cell Biology, Paracelsus Medical University Salzburg & Nuremberg, Salzburg, Austria; Ludwig Boltzmann Institute for Arthritis and Rehabilitation, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Hochberg', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Philip G', 'Initials': 'PG', 'LastName': 'Conaghan', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Chapel Allerton Hospital, Leeds, UK. Electronic address: P.Conaghan@leeds.ac.uk.'}]",Seminars in arthritis and rheumatism,['10.1016/j.semarthrit.2021.03.005'] 2608,33751506,The impact of multimodal therapies on the comfort and safety of patients in the immediate post-anaesthetic period following gynaecological procedures - part II.,"OBJECTIVES The second part of the study was to assess the effects of the types of anaesthesia along with multimodal analgesia on the stability of vital functions at the critical moment of awakening from anaesthesia. MATERIAL AND METHODS The material comprised the medical records at the Department of Anaesthesiology and Intensive Care in Szczecin. The anaesthesia record forms and recovery room observation charts of 150 patients from the Gynaecology Clinic who had undergone category III and IV surgical procedures between October 2018 and January 2019 were selected for analysis. The patients were divided into three groups: 1. Patients given multimodal analgesia with non-opioid and opioid analgesics. 2. Patients given multimodal analgesia with non-opioid analgesics and adjuvants. 3. Patients given multimodal analgesia with non-opioid and opioid analgesics, as well as neuraxial anaesthesia. RESULTS The average minimum heart rate in the operating room was 63.92 in group I, 61.48 in group II, and 62.34 in group III. The most common cause of bradycardia during surgery was insufflation. The average SBP prior to surgery was similar in groups I and II - 128.74 and 128.66, respectively. The average maximum values during surgery were 135.24 in group I, 139.34 in group II, and 142.32 in group III. At the time of discharge from the post-anaesthetic care unit, all the patients from the study group had achieved an Aldrete score of 10. Following the anaesthesia, 24% of the patients in group I, 22% in group II, and 28% in group III required oxygen therapy. CONCLUSIONS When using multimodal analgesia, the time required to fully awaken even after extensive surgical procedures was no longer than two hours.",2021,"The average SBP prior to surgery was similar in groups I and II - 128.74 and 128.66, respectively.","['150 patients from the Gynaecology Clinic who had undergone category III and IV surgical procedures between October 2018 and January 2019 were selected for analysis', 'patients in the immediate post-anaesthetic period following gynaecological procedures - part II']","['multimodal analgesia with non-opioid analgesics and adjuvants', 'multimodal analgesia with non-opioid and opioid analgesics']","['average minimum heart rate', 'average SBP prior to surgery', 'Aldrete score', 'stability of vital functions', 'average maximum values', 'bradycardia']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839674', 'cui_str': 'Gynecology clinic'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0242937', 'cui_str': 'Non-opioid analgesic'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1821424', 'cui_str': 'Post Anesthetic Recovery score'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}]",,0.021196,"The average SBP prior to surgery was similar in groups I and II - 128.74 and 128.66, respectively.","[{'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Biskup', 'Affiliation': 'Independent Public Clinical Hospital No. 1, Szczecin, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Plagens-Rotman', 'Affiliation': 'Hipolit Cegielski State University of Applied Sciences, Gniezno, Poland. plagens.rotman@gmail.com.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Polocka-Molinska', 'Affiliation': 'Hipolit Cegielski State University of Applied Sciences, Gniezno, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Merks', 'Affiliation': 'Faculty of Medicine, Collegium Medicum, Cardinal Stefan Wyszyński University, Warsaw, Poland.'}]",Ginekologia polska,['10.5603/GP.a2021.0022'] 2609,33824222,[New Management of Cluster Headache].,"Galcanezumab, a CGRP monoclonal antibody drug, has been approved by the U.S. Food and Drug Administration (FDA) for the prevention of recurrent cluster headaches. This was done after a randomized, double-blind, placebo-controlled trial found it to be effective and safe. Similarly sphenopalatine ganglion stimulation has been found to be effective and safe in a randomized, controlled trial as an acute treatment for chronic cluster headache. This article reviews the mechanisms of action of these therapies and their clinical trial results, clinical uses, and prospects in Japan.",2021,"Galcanezumab, a CGRP monoclonal antibody drug, has been approved by the U.S. Food and Drug Administration (FDA) for the prevention of recurrent cluster headaches.",['Japan'],"['Galcanezumab', 'placebo']",['effective and safe'],"[{'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C4694273', 'cui_str': 'galcanezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.551291,"Galcanezumab, a CGRP monoclonal antibody drug, has been approved by the U.S. Food and Drug Administration (FDA) for the prevention of recurrent cluster headaches.","[{'ForeName': 'Noboru', 'Initials': 'N', 'LastName': 'Imai', 'Affiliation': 'Department of Neurology, Japanese Red Cross Shizuoka Hospital.'}]",Brain and nerve = Shinkei kenkyu no shinpo,['10.11477/mf.1416201766'] 2610,33755640,"Does The Use of Ethyl Chloride Improve Patient-Reported Pain Scores with Negative Pressure Wound Therapy Dressing Changes? A Prospective, Randomized Controlled Trial.","BACKGROUND Negative pressure wound therapy (NPWT) is commonly used for surgical incisions and large wounds, particularly in the context of trauma. Research has shown that patients report the most painful aspect of NPWT is related to foam dressing changes. This study aimed to determine whether topical use of the vapocoolant anesthetic ethyl chloride would impact patient-reported pain during these procedures. METHODS This study was a single-blinded, placebo-controlled randomized trial in patients who were undergoing NPWT foam dressing change following surgery performed by the orthopaedic trauma team. A total of 100 patients were randomized to receive ethyl chloride topical anesthetic spray or placebo (tissue culture grade water) during dressing change. The outcome measure specified prior to enrollment was a mean decrease in patient-reported pain of 1.7 points using a numeric rating scale. Baseline and procedural characteristics were collected in order to investigate contributions to patient-reported pain. We hypothesized that the use of ethyl chloride would decrease patient reported pain scores. RESULTS Significantly more females were randomized to the receive vapocoolant; remaining baseline and procedural characteristics were similar between groups. The median time for NPWT drape removal was 2.0 minutes in both groups (p=0.66). The post-procedural pain reported by patients was significantly lower in the experimental group compared to placebo (median 5.0 vs 7.0, p=0.03). Multivariate analysis adjusting for potential confounders showed treatment group to be the strongest predictor of post-procedure pain (p=0.002). Additionally, a generalized linear model suggests that treatment group was the strongest predictor of change in pain score as reported by patients prior to and immediately following dressing change. CONCLUSIONS Use of vapocoolant spray during NPWT dressing change for orthopaedic trauma wounds and surgical incisions was feasible and resulted in significant reduction in patient-reported pain associated with the procedure.NCT04635696 (retrospectively registered). LEVEL OF EVIDENCE Therapeutic Level I.",2021,The median time for NPWT drape removal was 2.0 minutes in both groups (p=0.66).,"['100 patients', 'patients who were undergoing NPWT foam dressing change following surgery performed by the orthopaedic trauma team']","['Negative pressure wound therapy (NPWT', 'Ethyl Chloride', 'vapocoolant anesthetic ethyl chloride', 'vapocoolant spray', 'placebo', 'ethyl chloride topical anesthetic spray or placebo', 'ethyl chloride']","['post-procedural pain', 'pain score', 'patient-reported pain of 1.7 points using a numeric rating scale', 'pain scores', 'median time for NPWT drape removal']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C3164124', 'cui_str': 'Foam dressing'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1274117', 'cui_str': 'Trauma & orthopedics'}]","[{'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0015058', 'cui_str': 'Ethyl Chloride'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3211801', 'cui_str': 'Ethyl Chloride Topical Product'}]","[{'cui': 'C0877303', 'cui_str': 'Post procedural pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]",100.0,0.287011,The median time for NPWT drape removal was 2.0 minutes in both groups (p=0.66).,"[{'ForeName': 'Jason C', 'Initials': 'JC', 'LastName': 'Tank', 'Affiliation': 'Department of Orthopaedic Surgery, Section of Orthopaedic Trauma, ProMedica Toledo Hospital, Toledo, OH Enterostomal Therapy, ProMedica Toledo Hospital, Toledo OH Department of Orthopaedics, ProMedica Toledo Hospital, Toledo, OH Department of Mathematics and Statistics, Bowling Green State University, Bowling Green, OH ProMedica Research, ProMedica Toledo Hospital, Toledo OH.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Georgiadis', 'Affiliation': ''}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Bair', 'Affiliation': ''}, {'ForeName': 'Alexi', 'Initials': 'A', 'LastName': 'Rice', 'Affiliation': ''}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': ""O'Mara Gardner"", 'Affiliation': ''}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Roberta E', 'Initials': 'RE', 'LastName': 'Redfern', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000003157'] 2611,33759787,"Community-Integrated Intermediary Care (CIIC) Service Model to Enhance Family-Based, Long-Term Care for Older People: Protocol for a Cluster Randomized Controlled Trial in Thailand.","BACKGROUND Thailand is one of the most rapidly aging countries in Asia. Traditional family-based care, which has been the basis of most care for older people, is becoming unsustainable as families become smaller. In addition, women tend to be adversely affected as they still form the bulk of caregivers for older people, and many are likely to exit the labor market in order to provide care. Many family caregivers also have no or minimal training, and they may be called upon to provide quite complex care, increasing the proportion of older people receiving suboptimal care if they rely only on informal care that is provided by families and friends. Facing the increasing burden of noncommunicable diseases and age-related morbidity, Thai communities are increasingly in need of community-integrated care models for older persons that can link existing health systems and reduce the burden upon caring families. This need is common to many countries in the Association of Southeast Asian Nations (ASEAN). OBJECTIVE In this study, we aimed to assess the effectiveness of a community-integrated intermediary care (CIIC) model to enhance family-based care for older people. METHODS This paper describes a cluster randomized controlled trial comprised of 6 intervention clusters and 6 control clusters that aim to recruit 2000 participants in each arm. This research protocol has been approved by the World Health Organization Ethics Review Committee. The intervention clusters will receive an integrated model of care structured around (1) a community respite service, (2) the strengthening of family care capacity, and (3) an exercise program that aims to prevent entry into long-term care for older people. Control group clusters receive usual care (ie, the current system of long-term care common to all provinces in Thailand), consisting principally of a volunteer-assisted home care service. The trial will be conducted over a period of 2 years. The primary outcome is family caregiver burden measured at a 6-month follow-up, as measured by the Caregiver Burden Inventory. Secondary outcomes consist of biopsychosocial indicators including functional ability, as measured using an activity of daily living scale; depression, as measured by the Geriatric Depression Scale; and quality of life of older people, as measured by the EuroQol 5-dimensions 5-levels scale. Intention-to-treat analysis will be followed. RESULTS The CIIC facility has been established. Community care prevention programs have been launched at the intervention clusters. Family caregivers are receiving training and assistance. However, the COVID-19 pandemic delayed the intervention. CONCLUSIONS Since ASEAN and many Asian countries share similar traditional family-based, long-term care systems, the proposed CIIC model and the protocol for its implementation and evaluation may benefit other countries wishing to adopt similar community-integrated care models for older people at risk of needing long-term care. TRIAL REGISTRATION Thai Clinical Trials Registry TCTR20190412004; http://www.thaiclinicaltrials.org/. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/20196.",2021,"Secondary outcomes consist of biopsychosocial indicators including functional ability, as measured using an activity of daily living scale; depression, as measured by the Geriatric Depression Scale; and quality of life of older people, as measured by the EuroQol 5-dimensions 5-levels scale.","['older persons', 'older people', '2000 participants in each arm', 'Older People']","['integrated model of care structured around (1) a community respite service, (2) the strengthening of family care capacity, and (3) an exercise program that aims to prevent entry into long-term care', 'community-integrated intermediary care (CIIC) model', 'Control group clusters receive usual care (ie, the current system of long-term care common to all provinces in Thailand), consisting principally of a volunteer-assisted home care service', 'Community-Integrated Intermediary Care (CIIC']","['family caregiver burden measured at a 6-month follow-up, as measured by the Caregiver Burden Inventory', 'biopsychosocial indicators including functional ability, as measured using an activity of daily living scale; depression, as measured by the Geriatric Depression Scale; and quality of life of older people, as measured by the EuroQol 5-dimensions 5-levels scale']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0019855', 'cui_str': 'Services, Home Care'}]","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}]",,0.101027,"Secondary outcomes consist of biopsychosocial indicators including functional ability, as measured using an activity of daily living scale; depression, as measured by the Geriatric Depression Scale; and quality of life of older people, as measured by the EuroQol 5-dimensions 5-levels scale.","[{'ForeName': 'Myo Nyein', 'Initials': 'MN', 'LastName': 'Aung', 'Affiliation': 'Advanced Research Institute for Health Sciences and Faculty of International Liberal Arts, Juntendo University, Tokyo, Japan.'}, {'ForeName': 'Saiyud', 'Initials': 'S', 'LastName': 'Moolphate', 'Affiliation': 'Department of Public Health, Faculty of Science and Technology, Chiang Mai Rajabhat University, Chiang Mai, Thailand.'}, {'ForeName': 'Motoyuki', 'Initials': 'M', 'LastName': 'Yuasa', 'Affiliation': 'Faculty of International Liberal Arts, Juntendo University, Tokyo, Japan.'}, {'ForeName': 'Thin Nyein Nyein', 'Initials': 'TNN', 'LastName': 'Aung', 'Affiliation': 'Department of Public Health, Juntendo University, Tokyo, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Koyanagi', 'Affiliation': 'Tokyo Ariake University of Medical and Health Sciences, Tokyo, Japan.'}, {'ForeName': 'Siripen', 'Initials': 'S', 'LastName': 'Supakankunti', 'Affiliation': 'Faculty of Economics, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Ishtiaq', 'Initials': 'I', 'LastName': 'Ahmad', 'Affiliation': 'Department of Public Health, Juntendo University, Tokyo, Japan.'}, {'ForeName': 'Ryoma', 'Initials': 'R', 'LastName': 'Kayano', 'Affiliation': 'Centre for Health Development, World Health Organisation, Kobe, Japan.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ong', 'Affiliation': 'Centre for Health Development, World Health Organisation, Kobe, Japan.'}]",JMIR research protocols,['10.2196/20196'] 2612,33757914,Reply to: The benefit of adding lidocaine to ketamine during rapid sequence endotracheal intubation in patients with septic shock: A randomised controlled trial.,,2021,,['patients with septic shock'],"['ketamine', 'lidocaine']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]",[],,0.546152,,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cardinale', 'Affiliation': 'Intensive Care Unit, Sainte Anne Military Teaching Hospital, Toulon, France. Electronic address: mickaelcardinale@hotmail.fr.'}, {'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Mathais', 'Affiliation': 'Department of Anaesthesia, Sainte Anne Military Teaching Hospital, Toulon, France.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Nguyen', 'Affiliation': 'Department of Anaesthesia, Sainte Anne Military Teaching Hospital, Toulon, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Bordes', 'Affiliation': 'Department of Anaesthesia, Sainte Anne Military Teaching Hospital, Toulon, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Meaudre', 'Affiliation': 'Intensive Care Unit, Sainte Anne Military Teaching Hospital, Toulon, France.'}]","Anaesthesia, critical care & pain medicine",['10.1016/j.accpm.2021.100843'] 2613,33764613,"Efficacy of platelet-poor plasma gel in combination with fractional CO 2 laser in striae distensae: A clinical, histological, and immunohistochemical study.","BACKGROUND Platelet-poor plasma gel is a semi-solid plasma formulation that recently recommended as autologous bio-filler for treatment of atrophic dermal scars. AIM To compare the therapeutic efficacy and safety of intradermal injection of plasma gel in combination with fractional CO 2 laser versus fractional CO 2 laser alone in striae distensae (SD). PATIENTS AND METHODS This study included 36 SD patients treated by three sessions (one session/1.5 months) of fractional CO 2 laser on all SD lesions following intradermal injection of plasma gel on one side and saline (as placebo) on the other side. RESULTS Significant clinical improvements associated with remarkable narrowing of SD lesions and prominent enhancement of skin texture were observed on both treatment sides. Obviously, higher degrees of clinical improvements of SD lesions were reported following combined therapy with fractional CO 2 laser and plasma gel rather than fractional CO 2 laser monotherapy. However, post-inflammatory hyperpigmentation (PIH) was reported more frequently with fractional CO 2 laser monotherapy. Histopathological and immunohistochemical examinations revealed significant epidermal improvement, and homogenization, and orientation of dermal collagen bundles as a result of both therapeutic procedures. CONCLUSION Plasma gel in combination with fractional CO 2 laser could be considered a promising novel treatment modality for SD. Plasma gel not only improves the efficacy of fractional CO 2 laser but also decreases the frequency of PIH.",2021,"Histopathological and immunohistochemical examinations revealed significant epidermal improvement, and homogenization, and orientation of dermal collagen bundles as a result of both therapeutic procedures. ","['striae distensae (SD', 'striae distensae', '36 SD patients treated by 3 sessions (one session/1.5 months) of']","['fractional CO 2 laser versus fractional CO 2 laser alone', 'fractional CO 2 laser on all SD lesions following intradermal injection of plasma gel on one side, and saline (as placebo', 'platelet poor plasma gel', 'plasma gel']","['epidermal improvement, and homogenization, and orientation of dermal collagen bundles', 'remarkable narrowing of SD lesions and prominent enhancement of skin texture', 'therapeutic efficacy and safety', 'frequency of PIH']","[{'cui': 'C0152459', 'cui_str': 'Linear atrophy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0021489', 'cui_str': 'Intradermal injection'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0370219', 'cui_str': 'Platelet poor plasma'}]","[{'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0333164', 'cui_str': 'Narrow'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205402', 'cui_str': 'Prominent'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0423752', 'cui_str': 'Finding of skin texture'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0033373', 'cui_str': 'Prolactin inhibiting factor'}]",36.0,0.0525784,"Histopathological and immunohistochemical examinations revealed significant epidermal improvement, and homogenization, and orientation of dermal collagen bundles as a result of both therapeutic procedures. ","[{'ForeName': 'Samar El-Sayed', 'Initials': 'SE', 'LastName': 'Gad', 'Affiliation': 'Dermatology and Venereology Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Yomna Mazid El-Hamd', 'Initials': 'YME', 'LastName': 'Neinaa', 'Affiliation': 'Dermatology and Venereology Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Omnia Kamel', 'Initials': 'OK', 'LastName': 'Rizk', 'Affiliation': 'Pathology Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Nahla El-Sayed Ramzy', 'Initials': 'NER', 'LastName': 'Ghaly', 'Affiliation': 'Dermatology and Venereology Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}]",Journal of cosmetic dermatology,['10.1111/jocd.14102'] 2614,33763982,Comparison of the effects of ultrasound toothbrushes with different frequencies on oral hygiene: A randomized-controlled clinical trial.,"BACKGROUND The purpose of this study was to examine whether high-frequency ultrasound toothbrushes have different effects on oral hygiene. METHODS Fifty first-year dental hygiene students were randomly divided into three groups using ultrasound toothbrushes with different frequencies (1.6, 3.2 and 4.8 MHz) twice a day (3-min sessions) for 8 weeks. Plaque index (PlI) and gingival index (GI) scores were assessed at 4 and 8 weeks. RESULTS Changes in GI scores from baseline to 8 weeks tended to differ among the groups (p = 0.0862). The GI was significantly lower in the 3.2 and 4.8 MHz groups at 8 weeks (3.2 MHz group: p < 0.01, 4.8 MHz group: p < 0.05). At 4 weeks, the GI was significantly lower in the 3.2 MHz group (p < 0.05) and tended to be lower in the 4.8 MHz group (p = 0.07). The PlI was significantly lower in the 3.2 MHz group at 8 weeks (p < 0.01) and tended to be lower in the 1.6 and 4.8 MHz groups (1.6 MHz: p = 0.07, 4.8 MHz: p = 0.05). In addition, the PlI was significantly lower in the 4.8 MHz group at 4 weeks (p < 0.05). No significant differences in the changes in any measurements were observed among the groups. CONCLUSIONS The results of this study indicated that ultrasound toothbrushes with different frequencies probably have different effects on oral hygiene. However, it is difficult to conclude strongly that higher frequency ultrasound toothbrushes are more effective as there were some limitations.",2021,"The PlI was significantly lower in the 3.2 MHz group at 8 weeks (p < 0.01) and tended to be lower in the 1.6 and 4.8 MHz groups (1.6 MHz: p = 0.07, 4.8 MHz: p = 0.05).",['Fifty first-year dental hygiene students'],['ultrasound toothbrushes'],"['oral hygiene', 'GI scores', 'Plaque index (PlI) and gingival index (GI) scores']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}]","[{'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}]",50.0,0.0291368,"The PlI was significantly lower in the 3.2 MHz group at 8 weeks (p < 0.01) and tended to be lower in the 1.6 and 4.8 MHz groups (1.6 MHz: p = 0.07, 4.8 MHz: p = 0.05).","[{'ForeName': 'Akane', 'Initials': 'A', 'LastName': 'Takenouchi', 'Affiliation': 'Dental Hygiene Course, Shinjuku Medical Career College, Tokyo, Japan.'}, {'ForeName': 'Etsuyo', 'Initials': 'E', 'LastName': 'Otani', 'Affiliation': 'School of Health and Social Services, Saitama Prefectural University, Saitama, Japan.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Satoho', 'Affiliation': 'Taiyo Dental Hygienists School, Tokyo, Japan.'}, {'ForeName': 'Yumiko', 'Initials': 'Y', 'LastName': 'Kakegawa', 'Affiliation': 'Taiyo Dental Hygienists School, Tokyo, Japan.'}, {'ForeName': 'Hiroe', 'Initials': 'H', 'LastName': 'Arai', 'Affiliation': 'Taiyo Dental Hygienists School, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Matsukubo', 'Affiliation': 'Tokyo Dental College, Chiyoda, Japan.'}]",International journal of dental hygiene,['10.1111/idh.12496'] 2615,33763879,Immediate and lasting effects of aerobic exercise on the actigraphic sleep parameters of female nurses: A randomized controlled trial.,"Sleep disturbance is highly prevalent among shift-working nurses. We aimed to evaluate whether aerobic exercise (i.e., walking combined with jogging) improves objective sleep parameters among female nurses who met eligibility criterion as poor sleepers at the end of an 8-week exercise program and 4 weeks after study completion. This single-blinded, parallel-design, randomized controlled trial was conducted in a classroom of a hospital in northern Taiwan. Sixty eligible female nurses were randomly assigned to either the aerobic exercise (n = 30) or usual activity status (n = 30) group. A moderate-intensity aerobic exercise program was administered over 5 days (60 min per day) a week for 8 weeks after the nurses' day shifts. Objective sleep outcomes including total sleep time (TST), sleep onset latency (SOL), wake after sleep onset (WASO), and sleep efficiency (SE) were retrieved using an actigraph device. A generalized estimating equation model was used for data analysis. The aerobic exercise group exhibited improvements in TST and SE at 4 and 8 weeks compared with the baseline evaluation (TST: B = 70.49 and 55.96; SE: B = 5.21 and 3.98). Between-group differences were observed in SOL and WASO at 4 weeks but not 8 weeks compared with the baseline evaluation (SOL: B = -7.18; WASO: B = -11.38). Positive lasting effects for TST were observed only until the 4-week follow-up. To improve sleep quality and quantity, we encourage female nurses who sleep poorly to regularly perform moderate-intensity aerobic exercise.",2021,Between-group differences were observed in SOL and WASO at 4 weeks but not 8 weeks compared with the baseline evaluation (SOL: B = -7.18; WASO: B = -11.38).,"['classroom of a hospital in northern Taiwan', 'female nurses who sleep poorly to regularly perform moderate-intensity aerobic exercise', 'female nurses who met eligibility criterion as poor sleepers at the end of an 8-week exercise program and 4 weeks after study completion', 'Sixty eligible female nurses', 'female nurses']","['aerobic exercise', 'aerobic exercise (n\u2009=\u200930) or usual activity status', 'intensity aerobic exercise program', 'aerobic exercise (i.e., walking combined with jogging']","['Sleep disturbance', 'total sleep time (TST), sleep onset latency (SOL), wake after sleep onset (WASO), and sleep efficiency (SE', 'SOL and WASO', 'objective sleep parameters', 'actigraphic sleep parameters', 'sleep quality and quantity', 'TST and SE']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205169', 'cui_str': 'Bad'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0022400', 'cui_str': 'Jogging'}]","[{'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}]",60.0,0.0703031,Between-group differences were observed in SOL and WASO at 4 weeks but not 8 weeks compared with the baseline evaluation (SOL: B = -7.18; WASO: B = -11.38).,"[{'ForeName': 'Shu-Fen', 'Initials': 'SF', 'LastName': 'Niu', 'Affiliation': 'Department of Nursing, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chia-Jou', 'Initials': 'CJ', 'LastName': 'Lin', 'Affiliation': 'School of Nursing, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Pin-Yuan', 'Initials': 'PY', 'LastName': 'Chen', 'Affiliation': 'School of Medicine, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Yen-Chun', 'Initials': 'YC', 'LastName': 'Fan', 'Affiliation': 'School of Public Health, College of Public Health, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Hui-Chuan', 'Initials': 'HC', 'LastName': 'Huang', 'Affiliation': 'School of Nursing, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Hsiao-Yean', 'Initials': 'HY', 'LastName': 'Chiu', 'Affiliation': 'School of Nursing, Taipei Medical University, Taipei, Taiwan.'}]",Research in nursing & health,['10.1002/nur.22126'] 2616,33763126,Resting-State Network Plasticity Induced by Music Therapy after Traumatic Brain Injury.,"Traumatic brain injury (TBI) is characterized by a complex pattern of abnormalities in resting-state functional connectivity (rsFC) and network dysfunction, which can potentially be ameliorated by rehabilitation. In our previous randomized controlled trial, we found that a 3-month neurological music therapy intervention enhanced executive function (EF) and increased grey matter volume in the right inferior frontal gyrus (IFG) in patients with moderate-to-severe TBI ( N = 40). Extending this study, we performed longitudinal rsFC analyses of resting-state fMRI data using a ROI-to-ROI approach assessing within-network and between-network rsFC in the frontoparietal (FPN), dorsal attention (DAN), default mode (DMN), and salience (SAL) networks, which all have been associated with cognitive impairment after TBI. We also performed a seed-based connectivity analysis between the right IFG and whole-brain rsFC. The results showed that neurological music therapy increased the coupling between the FPN and DAN as well as between these networks and primary sensory networks. By contrast, the DMN was less connected with sensory networks after the intervention. Similarly, there was a shift towards a less connected state within the FPN and SAL networks, which are typically hyperconnected following TBI. Improvements in EF were correlated with rsFC within the FPN and between the DMN and sensorimotor networks. Finally, in the seed-based connectivity analysis, the right IFG showed increased rsFC with the right inferior parietal and left frontoparietal (Rolandic operculum) regions. Together, these results indicate that the rehabilitative effects of neurological music therapy after TBI are underpinned by a pattern of within- and between-network connectivity changes in cognitive networks as well as increased connectivity between frontal and parietal regions associated with music processing.",2021,The results showed that neurological music therapy increased the coupling between the FPN and DAN as well as between these networks and primary sensory networks.,"['Traumatic brain injury (TBI', 'patients with moderate-to-severe TBI ( N = 40', 'after Traumatic Brain Injury']","['Music Therapy', 'ROI-to-ROI approach assessing within-network and between-network rsFC', 'neurological music therapy intervention']","['frontoparietal (FPN), dorsal attention (DAN), default mode (DMN), and salience (SAL) networks', 'neurological music therapy', 'executive function (EF']","[{'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",,0.0521208,The results showed that neurological music therapy increased the coupling between the FPN and DAN as well as between these networks and primary sensory networks.,"[{'ForeName': 'Noelia', 'Initials': 'N', 'LastName': 'Martínez-Molina', 'Affiliation': 'Music, Ageing and Rehabilitation Team, Cognitive Brain Research Unit, Department of Psychology and Logopedics, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Sini-Tuuli', 'Initials': 'ST', 'LastName': 'Siponkoski', 'Affiliation': 'Music, Ageing and Rehabilitation Team, Cognitive Brain Research Unit, Department of Psychology and Logopedics, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Kuusela', 'Affiliation': 'Department of Physics, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Sari', 'Initials': 'S', 'LastName': 'Laitinen', 'Affiliation': 'Espoo Hospital, Espoo, Finland.'}, {'ForeName': 'Milla', 'Initials': 'M', 'LastName': 'Holma', 'Affiliation': 'Music Therapy Cooperative Instrumental, Helsinki, Finland.'}, {'ForeName': 'Mirja', 'Initials': 'M', 'LastName': 'Ahlfors', 'Affiliation': 'Private Music Therapy, Espoo, Finland.'}, {'ForeName': 'Päivi', 'Initials': 'P', 'LastName': 'Jordan-Kilkki', 'Affiliation': 'Dialogic Partner Oy, Espoo, Finland.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Ala-Kauhaluoma', 'Affiliation': 'Ludus Assessment and Intervention Services, Helsinki, Finland.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Melkas', 'Affiliation': 'Department of Neurology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Pekkola', 'Affiliation': 'HUS Medical Imaging Center, Department of Radiology, Helsinki Central University Hospital and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Rodríguez-Fornells', 'Affiliation': ""Cognition and Brain Plasticity Group, Bellvitge Biomedical Research Institute, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Laine', 'Affiliation': 'Department of Psychology, Åbo Akademi University, Turku, Finland.'}, {'ForeName': 'Aarne', 'Initials': 'A', 'LastName': 'Ylinen', 'Affiliation': 'Department of Neurology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Rantanen', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Sanna', 'Initials': 'S', 'LastName': 'Koskinen', 'Affiliation': 'Department of Psychology and Logopedics, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Benjamin Ultan', 'Initials': 'BU', 'LastName': 'Cowley', 'Affiliation': 'Faculty of Educational Sciences, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Teppo', 'Initials': 'T', 'LastName': 'Särkämö', 'Affiliation': 'Music, Ageing and Rehabilitation Team, Cognitive Brain Research Unit, Department of Psychology and Logopedics, University of Helsinki, Helsinki, Finland.'}]",Neural plasticity,['10.1155/2021/6682471'] 2617,33766835,Protocol for a randomised controlled trial comparing laparoscopic cholecystectomy with observation/conservative management for preventing recurrent symptoms and complications in adults with uncomplicated symptomatic gallstones (C-Gall trial).,"BACKGROUND Gallstone disease (cholelithiasis) is common. In most people it is asymptomatic and does not require treatment, but in about 20% it can become symptomatic, causing pain and other complications requiring medical attention and/or surgery. A proportion of symptomatic people with uncomplicated gallstone disease do not experience further episodes of pain and, therefore, could be treated conservatively. Moreover, surgery carries risks of perioperative and postoperative complications. METHODS AND ANALYSIS C-Gall is a pragmatic, multicentre, randomised controlled trial and economic evaluation to assess whether cholecystectomy is cost-effective compared with observation/ conservative management (here after referred to as medical management) at 18 months post-randomisation (with internal pilot). PRIMARY OUTCOME MEASURE Patient-reported quality of life (QoL) (36-Item Short Form Survey (SF-36) bodily pain domain) up to 18 months after randomisation.The primary economic outcome is incremental cost per quality-adjusted life year gained at 18 months. SECONDARY OUTCOME MEASURES Secondary outcome measures include condition-specific QoL, SF-36 domains, complications, further treatment, persistent symptoms, healthcare resource use, and costs assessed at 18 and 24 months after randomisation. The bodily pain domain of the SF-36 will also be assessed at 24 months after randomisation.A sample size of 430 participants was calculated. Computer-generated 1:1 randomisation was used.The C-Gall Study is currently in follow-up in 20 UK research centres. The first patient was randomised on 1 August 2016, with follow-up to be completed by 30 November 2021. STATISTICAL ANALYSIS Statistical analysis of the primary outcome will be intention-to-treat and a per-protocol analysis. The primary outcome, area under the curve (AUC) for the SF-36 bodily pain up to 18 months, will be generated using the Trapezium rule and analysed using linear regression with adjustment for the minimisation variables (recruitment site, sex and age). For the secondary outcome, SF-36 bodily pain, AUC up to 24 months will be analysed in a similar way. Other secondary outcomes will be analysed using generalised linear models with adjustment for minimisation and baseline variables, as appropriate. Statistical significance will be at the two-sided 5% level with corresponding CIs. ETHICS AND DISSEMINATION The North of Scotland Research Ethics Committee approved this study (16/NS/0053). The dissemination plans include Health Technology Assessment monograph, international scientific meetings and publications in high-impact, open-access journals. TRIAL REGISTRATION NUMBER ISRCTN55215960; pre-results.",2021,"For the secondary outcome, SF-36 bodily pain, AUC up to 24 months will be analysed in a similar way.","['430 participants was calculated', 'adults with uncomplicated symptomatic gallstones (C-Gall trial']","['laparoscopic cholecystectomy with observation/conservative management', 'cholecystectomy']","['area under the curve (AUC) for the SF-36 bodily pain', 'incremental cost per quality-adjusted life year gained at 18 months', 'SF-36 bodily pain, AUC', 'condition-specific QoL, SF-36 domains, complications, further treatment, persistent symptoms, healthcare resource use, and costs assessed', 'quality of life (QoL) (36-Item Short Form Survey (SF-36) bodily pain domain']","[{'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0008350', 'cui_str': 'Biliary calculus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",430.0,0.491251,"For the secondary outcome, SF-36 bodily pain, AUC up to 24 months will be analysed in a similar way.","[{'ForeName': 'Irfan', 'Initials': 'I', 'LastName': 'Ahmed', 'Affiliation': 'Department of Surgery, NHS Grampian, Aberdeen, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Innes', 'Affiliation': 'Health Services Research Unit, University of Aberdeen Health Services Research Unit, Aberdeen, UK kareninnes@abdn.ac.uk.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Brazzelli', 'Affiliation': 'Health Services Research Unit, University of Aberdeen Health Services Research Unit, Aberdeen, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Gillies', 'Affiliation': 'Health Services Research Unit, University of Aberdeen Health Services Research Unit, Aberdeen, UK.'}, {'ForeName': 'Rumana', 'Initials': 'R', 'LastName': 'Newlands', 'Affiliation': 'Health Services Research Unit, University of Aberdeen College of Life Sciences and Medicine, Aberdeen, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Avenell', 'Affiliation': 'Health Services Research Unit, University of Aberdeen Health Services Research Unit, Aberdeen, UK.'}, {'ForeName': 'Rodolfo', 'Initials': 'R', 'LastName': 'Hernández', 'Affiliation': 'Health Economics Research Unit (HERU), University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Blazeby', 'Affiliation': 'Centre for Surgical Research and NIHR Bristol and Weston Biomedical Research Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Croal', 'Affiliation': 'Clinical Biochemistry, NHS Grampian, Aberdeen, UK.'}, {'ForeName': 'Jemma', 'Initials': 'J', 'LastName': 'Hudson', 'Affiliation': 'Health Services Research Unit, University of Aberdeen Health Services Research Unit, Aberdeen, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'Health Services Research Unit, University of Aberdeen Health Services Research Unit, Aberdeen, UK.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'McCormack', 'Affiliation': 'Health Services Research Unit, University of Aberdeen Health Services Research Unit, Aberdeen, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'McDonald', 'Affiliation': 'Health Services Research Unit, University of Aberdeen Health Services Research Unit, Aberdeen, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Murchie', 'Affiliation': 'Academic Primary Care, Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Ramsay', 'Affiliation': 'Health Services Research Unit, University of Aberdeen Health Services Research Unit, Aberdeen, UK.'}]",BMJ open,['10.1136/bmjopen-2020-039781'] 2618,33766759,"Efficacy and safety of Soshiho-tang in atopic dermatitis patients with gastrointestinal disorders: A double-blinded, randomized, and placebo-controlled clinical trial.","ETHNOPHARMACOLOGICAL RELEVANCE Because of the growing incidence of AD, psychosocial and economic burden of AD patients are often considerable. Steroid treatments are widely used, but long term use of this treatment can cause side effects. To reduce the burden of AD patients and find new efficient treatment, this study chose Soshiho-tang, a traditional medicine used in eastern Asia. AIM OF THE STUDY Soshiho-tang (SSHT) is a traditional herbal medicine that has anti-inflammatory effects and improves immune function. This clinical trial evaluated the efficacy and safety of SSHT in atopic dermatitis (AD) patients with gastrointestinal disorders in comparison with placebo. MATERIALS AND METHODS This study was a single-center, randomized, double-blinded, placebo-controlled, and investigator-initiated clinical trial. A total of 60 patients aged 3-18 years with gastrointestinal disorders and diagnosed with AD by Hanifin & Rajka criteria with a Scoring Atopic Dermatitis (SCORAD) index between 15 and 49 were enrolled. Participants were randomly assigned to the SSHT or placebo groups in a ratio of 1:1 and efficacy evaluation was conducted at week 4 and 8. The participants orally administered SSHT or placebo three times a day for 4 weeks. The primary outcome was measured based on a change of SCORAD index. The secondary outcome measurements included the following: survey questionnaires of gastrointestinal disorder, amount and frequency of ointment application for AD, dermatology quality of life index, and safety evaluation (diagnostic test, adverse reaction, and vital sign monitoring). RESULTS During efficacy evaluation, the SCORAD score and digestive symptoms in the experimental and placebo groups were not statistically significant. However, the amount and frequency of ointment application in the experimental group were reduced compared to those in the placebo group at week 8. Also, In the Children's Dermatology Life Quality Index (CDLQI), statistically significant Quality of Life (QOL) improvement was observed in the SSHT experimental group compared to the placebo group. In safety evaluation, all participants were within the normal range during the study period. Blood sample testing indicated that the lymphocytes ratio decreased, and neutrophils ratio increased in the experimental group, whereas the placebo group showed the opposite immune response pattern. CONCLUSION We concluded that SSHT administration can reduce steroid ointment dependence and improve the QOL in AD patients by regulating neutrophil-lymphocyte ratio.",2021,"However, the amount and frequency of ointment application in the experimental group were reduced compared to those in the placebo group at week 8.","['atopic dermatitis (AD) patients with gastrointestinal disorders in comparison with placebo', '60 patients aged 3 to 18 years with gastrointestinal disorders and diagnosed with AD by Hanifin & Rajka criteria with a Scoring Atopic Dermatitis (SCORAD) index between 15 and 49 were enrolled', 'atopic dermatitis patients with gastrointestinal disorders']","['SSHT or placebo', 'SSHT', 'Soshiho-tang', 'placebo', 'Soshiho-tang (SSHT']","['survey questionnaires of gastrointestinal disorder, amount and frequency of ointment application for AD, dermatology quality of life index, and safety evaluation (diagnostic test, adverse reaction, and vital sign monitoring', 'lymphocytes ratio decreased, and neutrophils ratio', 'SCORAD score and digestive symptoms', 'Quality of Life (QOL) improvement', 'change of SCORAD index', 'Dermatology Life Quality Index (CDLQI', 'steroid ointment dependence', 'Efficacy and safety']","[{'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017178', 'cui_str': 'Disorder of gastrointestinal tract'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3657623', 'cui_str': 'soshiho-tang'}]","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0017178', 'cui_str': 'Disorder of gastrointestinal tract'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0430022', 'cui_str': 'Diagnostic procedure'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0476288', 'cui_str': 'Digestive symptom'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",60.0,0.623766,"However, the amount and frequency of ointment application in the experimental group were reduced compared to those in the placebo group at week 8.","[{'ForeName': 'Ju Hyun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Korean Medicine Ophthalmology and Otolaryngology and Dermatology, Wonkwang University Korean Medicine Hospital, Iksan, Jeollabuk-do, Republic of Korea. Electronic address: tony9403@naver.com.'}, {'ForeName': 'Eun Heui', 'Initials': 'EH', 'LastName': 'Jo', 'Affiliation': 'Department of Acupuncture and Moxibustion, Wonkwang University Korean Medicine Hospital and Research Center of Traditional Korean Medicine, Wonkwang University, Deokjingu, Jeonju, Jeollabuk-do, Republic of Korea. Electronic address: freezo@wonkwang.ac.kr.'}, {'ForeName': 'Jee Youn', 'Initials': 'JY', 'LastName': 'Jung', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea. Electronic address: jjy0918@kiom.re.kr.'}, {'ForeName': 'Su Jin', 'Initials': 'SJ', 'LastName': 'Kang', 'Affiliation': 'Department of Korean Medicine Obstetrics & Gynecology, Wonkwang University Korean Medicine Hospital, Iksan, Jeollabuk-do, Republic of Korea. Electronic address: blissooj@hanmail.net.'}, {'ForeName': 'Geum Jin', 'Initials': 'GJ', 'LastName': 'Yang', 'Affiliation': 'Korean Medicine Dermatology Clinical Research Center of Wonkwang University, Iksan, Jeollabuk-do, Republic of Korea. Electronic address: goomdin2@hanmail.net.'}, {'ForeName': 'Yu Hwa', 'Initials': 'YH', 'LastName': 'Shim', 'Affiliation': 'Korean Medicine Dermatology Clinical Research Center of Wonkwang University, Iksan, Jeollabuk-do, Republic of Korea. Electronic address: loveis630@naver.com.'}, {'ForeName': 'Min Cheol', 'Initials': 'MC', 'LastName': 'Park', 'Affiliation': 'Department of Korean Medicine Ophthalmology and Otolaryngology and Dermatology, Wonkwang University Korean Medicine Hospital and Research Center of Traditional Korean Medicine, Wonkwang University, Iksan, Jeollabuk-do, Republic of Korea. Electronic address: spinx11@wonkwang.ac.kr.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2021.114006'] 2619,33766702,Head and neck cancer patients under (chemo-)radiotherapy undergoing nutritional intervention: Results from the prospective randomized HEADNUT-trial.,"PURPOSE/OBJECTIVE Patients with squamous cell carcinoma of the head and neck undergoing (chemo-)radiotherapy are at high risk of malnutrition. Nevertheless, there is still a lack of prospective, randomized trials investigating the influence of nutritional status on therapy-related toxicity and patients' outcome. MATERIALS AND METHODS Between October 2018 and October 2020, 61 patients were randomized into an intervention and control group. Questionnaires (MUST, NRS-2002, and Nutriscore), clinical examinations, laboratory analyses, and bioelectrical impedance analysis (BIA) were used to assess nutritional status for all patients at the beginning and end of therapy as well as every 2 weeks during therapy. The intervention consisted of an individualized nutritional counseling every 2 weeks during therapy. RESULTS Median baseline BMI for all participants was 23.8 (14.5-37.2) kg/m 2 and dropped to 22.9 (16.8-33) kg/m 2 after therapy (p < 0.001). In all patients, median baseline fat-free mass index (FFMI) was 18.1 (14-24.7) kg/m 2 and decreased to 17.8 (13.4-21.6) kg/m 2 till the end of therapy (p < 0.001). Compliant patients with a BMI < 22 kg/m 2 presented with less weight loss in the intervention group compared to the control (p = 0.015, CI: 0.33-2.95). At baseline, MUST was the only screening-test which showed both good sensitivity (86%) and specificity (88%) in detecting malnutrition. Median follow-up was 15 (1-26) months and is still ongoing. 2-year overall survival rate was 70% in the control and 79% in the intervention group (log-rank p = 0.79). Pretherapeutic phase angle, posttherapeutic FFMI and albumin level were prognostic indicators for overall survival (log-rank p = 0.002, p = 0.008 and p = 0.016). CONCLUSIONS Malnutrition negatively impacts patients' outcome under (chemo-)radiotherapy. Baseline phase angle, posttherapeutic FFMI and albumin level are proposed as reliable indicators for overall survival. This study was registered within the German Clinical Trials Register (DRKS00016862).",2021,"In all patients, median baseline fat-free mass index (FFMI) was 18.1 (14-24.7) kg/m 2 and decreased to 17.8 (13.4-21.6) kg/m 2 till the end of therapy (p<0.001).","['Between October 2018 and October 2020, 61 patients', 'Patients with squamous cell carcinoma of the head and neck undergoing (chemo-)radiotherapy are at high risk of malnutrition', 'Head and neck cancer patients under ']","['chemo-)radiotherapy undergoing nutritional intervention', 'individualized nutritional counseling']","['Pretherapeutic phase angle, posttherapeutic FFMI and albumin level', 'Baseline phase angle, posttherapeutic FFMI and albumin level', 'Questionnaires (MUST, NRS-2002, and Nutriscore), clinical examinations, laboratory analyses, and bioelectrical impedance analysis (BIA', 'median baseline fat-free mass index (FFMI', '2-year overall survival rate', 'weight loss', 'overall survival', 'good sensitivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}]","[{'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}]","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0201838', 'cui_str': 'Albumin measurement'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0162536', 'cui_str': 'Biolectric Impedance'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",61.0,0.127854,"In all patients, median baseline fat-free mass index (FFMI) was 18.1 (14-24.7) kg/m 2 and decreased to 17.8 (13.4-21.6) kg/m 2 till the end of therapy (p<0.001).","[{'ForeName': 'Anastassia', 'Initials': 'A', 'LastName': 'Löser', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Outpatient Center of the UKE GmbH, Department of Radiotherapy and Radiation Oncology, Hamburg, Germany. Electronic address: an.loeser@uke.de.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Abel', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Outpatient Center of the UKE GmbH, Department of Radiotherapy and Radiation Oncology, Hamburg, Germany.'}, {'ForeName': 'Laura Magdalena', 'Initials': 'LM', 'LastName': 'Kutz', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Outpatient Center of the UKE GmbH, Department of Radiotherapy and Radiation Oncology, Hamburg, Germany.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Krause', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Institute of Medical Biometry and Epidemiology, Hamburg, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Finger', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Outpatient Center of the UKE GmbH, Department of Radiotherapy and Radiation Oncology, Hamburg, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Greinert', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Outpatient Center of the UKE GmbH, Department of Radiotherapy and Radiation Oncology, Hamburg, Germany.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Sommer', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Outpatient Center of the UKE GmbH, Department of Radiotherapy and Radiation Oncology, Hamburg, Germany.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Lorenz', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Outpatient Center of the UKE GmbH, Department of Radiotherapy and Radiation Oncology, Hamburg, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Culmann', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Outpatient Center of the UKE GmbH, Department of Radiotherapy and Radiation Oncology, Hamburg, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'von Grundherr', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, University Cancer Center Hamburg, Germany.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Wegert', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, University Cancer Center Hamburg, Germany.'}, {'ForeName': 'Loreen', 'Initials': 'L', 'LastName': 'Lehmann', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Outpatient Center of the UKE GmbH, Department of Radiotherapy and Radiation Oncology, Hamburg, Germany.'}, {'ForeName': 'Gesa', 'Initials': 'G', 'LastName': 'Matnjani', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Outpatient Center of the UKE GmbH, Department of Radiotherapy and Radiation Oncology, Hamburg, Germany.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Schwarz', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Outpatient Center of the UKE GmbH, Department of Radiotherapy and Radiation Oncology, Hamburg, Germany.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Brackrock', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Outpatient Center of the UKE GmbH, Department of Radiotherapy and Radiation Oncology, Hamburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Krüll', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Outpatient Center of the UKE GmbH, Department of Radiotherapy and Radiation Oncology, Hamburg, Germany; University Medical Center Hamburg-Eppendorf, Department of Radiotherapy and Radiation Oncology, Hamburg, Germany.'}, {'ForeName': 'Cordula', 'Initials': 'C', 'LastName': 'Petersen', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Radiotherapy and Radiation Oncology, Hamburg, Germany; University Medical Center Hamburg-Eppendorf, Outpatient Center of the UKE GmbH, Department of Radiotherapy and Radiation Oncology, Hamburg, Germany.'}, {'ForeName': 'Cedric Oliver', 'Initials': 'CO', 'LastName': 'Carl', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Outpatient Center of the UKE GmbH, Department of Radiotherapy and Radiation Oncology, Hamburg, Germany.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2021.03.019'] 2620,33752431,Randomized controlled trial of PosiFlow regulator with infusion clamp for reducing intravenous catheter plugging.,"BACKGROUND Intravenous (IV) catheter insertion may cause adverse reactions. It is necessary to investigate optimal methods for reducing blood return and extending the usage time of IV catheter by existing technologies. We investigated the efficacy of the PosiFlow regulator with an infusion clip for preventing IV catheter plugging due to venous blood return. METHODS From January 2017 to August 2017, 960 patients requiring IV catheterization were recruited and by using the block randomization method randomly allocated to 4 groups (n=240 in each group): a control group receiving IV catheter with infusion clip; experimental group A receiving IV catheter without infusion clip; experimental group B receiving an IV catheter with the PosiFlow regulator; and experimental group C receiving an IV catheter with a PosiFlow regulator and infusion clip. The rates of catheter plugging and blood return were compared among groups. RESULTS In different reasons for needle pulling, The rates of catheter plugging and blood return in experimental group C (Received IV catheterization with an infusion clip and PosiFlow regulato) were the lowest among all groups (P<0.05). In different puncture sites, forearm puncture further reduced IV catheter plugging in all groups compared to other puncture sites. CONCLUSIONS Catheter plugging and blood return can be significantly reduced by combining the PosiFlow regulator and an infusion clip, resulting in reduced medical costs and patient distress from catheter reinsertion.",2021,"In different puncture sites, forearm puncture further reduced IV catheter plugging in all groups compared to other puncture sites. ","['From January 2017 to August 2017, 960 patients requiring IV catheterization']","['control group receiving IV catheter with infusion clip; experimental group A receiving IV catheter without infusion clip; experimental group B receiving an IV catheter with the PosiFlow regulator; and experimental group C receiving an IV catheter with a PosiFlow regulator and infusion clip', 'PosiFlow regulator with an infusion clip', 'PosiFlow regulator with infusion clamp']","['intravenous catheter plugging', 'forearm puncture further reduced IV catheter plugging', 'rates of catheter plugging and blood return']","[{'cui': 'C4517908', 'cui_str': '960'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0745442', 'cui_str': 'Venous catheter'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}]","[{'cui': 'C0745442', 'cui_str': 'Venous catheter'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0332156', 'cui_str': 'Return to'}]",,0.0763134,"In different puncture sites, forearm puncture further reduced IV catheter plugging in all groups compared to other puncture sites. ","[{'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Mi', 'Affiliation': 'Department of Hepatobiliary Surgery, the Second Affiliated Hospital of Army Medical University, Chongqing, China.'}, {'ForeName': 'Dahua', 'Initials': 'D', 'LastName': 'Lan', 'Affiliation': 'Medical Center of Hematology, the Second Affiliated Hospital of Army Medical University, Chongqing, China.'}, {'ForeName': 'Zhili', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': ""Dean's office, Army Medical University, Chongqing, China.""}, {'ForeName': 'Fengxia', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Department of Hepatobiliary Surgery, the Second Affiliated Hospital of Army Medical University, Chongqing, China.'}, {'ForeName': 'Zhenling', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Hepatobiliary Surgery, the Second Affiliated Hospital of Army Medical University, Chongqing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Hepatobiliary Surgery, the Second Affiliated Hospital of Army Medical University, Chongqing, China.'}, {'ForeName': 'Shuting', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Hepatobiliary Surgery, the Second Affiliated Hospital of Army Medical University, Chongqing, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Department of Hepatobiliary Surgery, the Second Affiliated Hospital of Army Medical University, Chongqing, China.'}, {'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Hepatobiliary Surgery, the Second Affiliated Hospital of Army Medical University, Chongqing, China.'}, {'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': 'Department of Hepatobiliary Surgery, the Second Affiliated Hospital of Army Medical University, Chongqing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Hepatobiliary Surgery, the Second Affiliated Hospital of Army Medical University, Chongqing, China. xqyylj@163.com.'}]",Annals of palliative medicine,['10.21037/apm-21-145'] 2621,33752426,Safety and effectiveness of dual guidance with video-laryngoscopy and ultrasound in jejunal tube placement in patients undergoing invasive mechanical ventilation.,"BACKGROUND Appropriate and effective post-pyloric enteral nutrition (EN) is valuable for patients undergoing invasive ventilation, but blind bedside insertion of jejunal tubes is often difficult during mechanical ventilation. Here, we first report on the safety and effectiveness of inserting the jejunal tubes under the dual guidance (DG) of video-laryngoscopy and ultrasound in patients in whom jejunal tube placement during invasive mechanical ventilation is difficult. METHODS Twenty patients in the emergency department-based intensive care unit (ICU) who were receiving invasive mechanical ventilation and had difficulty in jejunal tube placement were selected for video-laryngoscopy and ultrasound-guided jejunal tube placement (the DG group), and the outcomes were compared with patients experiencing difficult intubation before the introduction of the DG technique (the control group) in terms of the incidence of postintubation complications and the effectiveness and efficiency of nutritional support. RESULTS The DG group had a significantly higher success rate of intubation and better nutritional status than the control group. The incidences of nasopharyngeal bleeding, dental and gingival injuries, and tracheostomy tube dislodgement were not significantly increased in the DG group, and the blood pressure and heart rate also showed no significant fluctuations. CONCLUSIONS DG with both video-laryngoscopy and ultrasound is a safe and effective technique in patients with difficulty in jejunal tube placement.",2021,"The incidences of nasopharyngeal bleeding, dental and gingival injuries, and tracheostomy tube dislodgement were not significantly increased in the DG group, and the blood pressure and heart rate also showed no significant fluctuations. ","['Twenty patients in the emergency department-based intensive care unit (ICU) who were receiving', 'patients undergoing invasive ventilation', 'patients undergoing invasive mechanical ventilation', 'patients with difficulty in jejunal tube placement']","['jejunal tubes under the dual guidance (DG) of video-laryngoscopy and ultrasound in patients in whom jejunal tube placement during invasive mechanical ventilation', 'invasive mechanical ventilation and had difficulty in jejunal tube placement were selected for video-laryngoscopy and ultrasound-guided jejunal tube placement', 'pyloric enteral nutrition (EN', 'dual guidance with video-laryngoscopy and ultrasound in jejunal tube placement']","['safety and effectiveness', 'success rate of intubation and better nutritional status', 'blood pressure and heart rate', 'incidences of nasopharyngeal bleeding, dental and gingival injuries, and tracheostomy tube dislodgement', 'Safety and effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0022378', 'cui_str': 'Jejunal'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0022378', 'cui_str': 'Jejunal'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0034196', 'cui_str': 'Pyloric structure of stomach'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0560621', 'cui_str': 'Gum injury'}, {'cui': 'C0184159', 'cui_str': 'Tracheostomy tube'}]",20.0,0.0179938,"The incidences of nasopharyngeal bleeding, dental and gingival injuries, and tracheostomy tube dislodgement were not significantly increased in the DG group, and the blood pressure and heart rate also showed no significant fluctuations. ","[{'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Wu', 'Affiliation': 'Department of Endocrinology, Shengjing Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Haitao', 'Initials': 'H', 'LastName': 'Shen', 'Affiliation': 'Department of Emergency Medicine, Shengjing Hospital of China Medical University, Shenyang, China. shenht@sj-hospital.org.'}]",Annals of palliative medicine,['10.21037/apm-21-139'] 2622,33752148,Effects of preoperative oral single-dose and double-dose carbohydrates on insulin resistance in patients undergoing gastrectomy:a prospective randomized controlled trial.,"BACKGROUND & AIMS Preoperative oral carbohydrates are strongly recommended for routine use before various elective procedures. The regimen mainly includes preoperative oral single-dose carbohydrate (2-3 h before surgery) and preoperative oral double-dose carbohydrates (10 h before surgery and 2-3 h before surgery). The choice between the two options is still controversial. METHODS A total of 139 patients with gastric cancer who underwent radical gastrectomy were recruited from a hospital in Sichuan Province, China. The patients were randomly assigned to a single-dose group (n = 70) or a double-dose group (n = 69). Insulin resistance indicators, subjective comfort indicators, inflammatory mediators, immunological indicators, postoperative recovery indexes, and complications were compared between the two groups. RESULTS There were no differences in insulin resistance indicators (fasting plasma glucose, fasting insulin, and homeostasis model assessment indexes), inflammatory mediators (C-reactive protein, interleukin-6, and tumor necrosis factor-α), immunological indicators (CD3+, CD4+, CD8+, and CD4+/CD8+) between the single-dose group and double-dose group (all P > 0.05) at preoperative day 1, preoperative 3 h, and postoperative day 1. There were no differences in subjective comfort indicators (thirst, hunger, anxiety, nausea, fatigue, and weakness) between the two groups (all P > 0.05) at preoperative day 1, preoperative 3 h, preoperative 1 h, and postoperative day 1. The postoperative recovery indexes and complications (exhaust time, liquid intake time, postoperative hospital stay, complication incidence, unplanned readmission rate, and unplanned reoperation rate 30 days after operation) did not significantly differ between the two groups (all P > 0.05). The number of preoperative nighttime urinations in the double-dose group was higher than that in the single-dose group (88.3% VS 48.5%, P < 0.001), and the number of hours of preoperative sleep in the double-dose group was lower than that in the single-dose group (4.56 ± 0.68 VS 5.71 ± 0.57, P < 0.001). CONCLUSION Oral carbohydrates administered the night before surgery did not enhance the effects of oral carbohydrates administered 2-3 h before surgery on insulin resistance, subjective comfort, inflammation, and immunity and might affect the patients' night rest. In making a decision between oral carbohydrate regimes, evening carbohydrates could be omitted. TRIAL REGISTRATION ChiCTR, ChiCTR1900020608. Registered January 10, 2019, http://www.chictr.org.cn: ChiCTR1900020608.",2021,"There were no differences in subjective comfort indicators (thirst, hunger, anxiety, nausea, fatigue, and weakness) between the two groups (all P > 0.05) at preoperative day 1, preoperative 3 h, preoperative 1 h, and postoperative day 1.","['139 patients with gastric cancer who underwent radical gastrectomy were recruited from a hospital in Sichuan Province, China', 'Registered January 10, 2019, http://www.chictr.org.cn', 'patients undergoing gastrectomy']","['preoperative oral single-dose carbohydrate (2-3\xa0h before surgery) and preoperative oral double-dose carbohydrates', 'preoperative oral single-dose and double-dose carbohydrates']","['insulin resistance, subjective comfort, inflammation, and immunity', 'insulin resistance', 'number of preoperative nighttime urinations', 'Insulin resistance indicators, subjective comfort indicators, inflammatory mediators, immunological indicators, postoperative recovery indexes, and complications', 'postoperative recovery indexes and complications (exhaust time, liquid intake time, postoperative hospital stay, complication incidence, unplanned readmission rate, and unplanned reoperation rate 30 days after operation', 'insulin resistance indicators (fasting plasma glucose, fasting insulin, and homeostasis model assessment indexes), inflammatory mediators (C-reactive protein, interleukin-6, and tumor necrosis factor-α), immunological indicators (CD3+, CD4+, CD8+, and CD4+/CD8', 'subjective comfort indicators (thirst, hunger, anxiety, nausea, fatigue, and weakness', 'number of hours of preoperative sleep']","[{'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0565313', 'cui_str': 'Radical gastrectomy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0020964', 'cui_str': 'Immune status'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]",139.0,0.226818,"There were no differences in subjective comfort indicators (thirst, hunger, anxiety, nausea, fatigue, and weakness) between the two groups (all P > 0.05) at preoperative day 1, preoperative 3 h, preoperative 1 h, and postoperative day 1.","[{'ForeName': 'Xinrong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'West China School of Nursing /West China Hospital, Sichuan University, Chengdu, 610041, Sichuan Province, China.'}, {'ForeName': 'Ka', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'West China School of Nursing /West China Hospital, Sichuan University, Chengdu, 610041, Sichuan Province, China. Electronic address: lika127@126.com.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Yang', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital,Sichuan University, Chengdu, 610041, Sichuan Province, China.'}, {'ForeName': 'Jiankun', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital,Sichuan University, Chengdu, 610041, Sichuan Province, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital,Sichuan University, Chengdu, 610041, Sichuan Province, China.'}, {'ForeName': 'Jinhua', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'West China School of Nursing /West China Hospital, Sichuan University, Chengdu, 610041, Sichuan Province, China.'}, {'ForeName': 'Yanjie', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'West China School of Nursing /West China Hospital, Sichuan University, Chengdu, 610041, Sichuan Province, China.'}, {'ForeName': 'Xingxia', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'West China School of Nursing /West China Hospital, Sichuan University, Chengdu, 610041, Sichuan Province, China.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2021.03.002'] 2623,33752127,Itraconazole for COVID-19: preclinical studies and a proof-of-concept randomized clinical trial.,"BACKGROUND The antifungal drug itraconazole exerts in vitro activity against SARS-CoV-2 in Vero and human Caco-2 cells. Preclinical and clinical studies are required to investigate if itraconazole is effective for the treatment and/or prevention of COVID-19. METHODS Due to the initial absence of preclinical models, the effect of itraconazole was explored in a clinical, proof-of-concept, open-label, single-center study, in which hospitalized COVID-19 patients were randomly assigned to standard of care with or without itraconazole. Primary outcome was the cumulative score of the clinical status until day 15 based on the 7-point ordinal scale of the World Health Organization. In parallel, itraconazole was evaluated in a newly established hamster model of acute SARS-CoV-2 infection and transmission, as soon as the model was validated. FINDINGS In the hamster acute infection model, itraconazole did not reduce viral load in lungs, stools or ileum, despite adequate plasma and lung drug concentrations. In the transmission model, itraconazole failed to prevent viral transmission. The clinical trial was prematurely discontinued after evaluation of the preclinical studies and because an interim analysis showed no signal for a more favorable outcome with itraconazole: mean cumulative score of the clinical status 49 vs 47, ratio of geometric means 1.01 (95% CI 0.85 to 1.19) for itraconazole vs standard of care. INTERPRETATION Despite in vitro activity, itraconazole was not effective in a preclinical COVID-19 hamster model. This prompted the premature termination of the proof-of-concept clinical study. FUNDING KU Leuven, Research Foundation - Flanders (FWO), Horizon 2020, Bill and Melinda Gates Foundation.",2021,"In the hamster acute infection model, itraconazole did not reduce viral load in lungs, stools or ileum, despite adequate plasma and lung drug concentrations.",['hospitalized COVID-19 patients'],"['Itraconazole', 'itraconazole', 'standard of care with or without itraconazole']","['cumulative score of the clinical status until day 15 based on the 7-point ordinal scale of the World Health Organization', 'viral transmission', 'viral load in lungs, stools or ileum, despite adequate plasma and lung drug concentrations']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0020885', 'cui_str': 'Ileal structure'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.260187,"In the hamster acute infection model, itraconazole did not reduce viral load in lungs, stools or ileum, despite adequate plasma and lung drug concentrations.","[{'ForeName': 'Laurens', 'Initials': 'L', 'LastName': 'Liesenborghs', 'Affiliation': 'Laboratory of Virology and Chemotherapy, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium; The Outbreak Research Team, Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium. Electronic address: lliesenborghs@itg.be.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Spriet', 'Affiliation': 'Pharmacy Department University Hospitals Leuven and Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Belgium.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Jochmans', 'Affiliation': 'Laboratory of Virology and Chemotherapy, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Belmans', 'Affiliation': 'KU Leuven - University of Leuven & Universiteit Hasselt, I-BioStat, Leuven, Belgium.'}, {'ForeName': 'Iwein', 'Initials': 'I', 'LastName': 'Gyselinck', 'Affiliation': 'Department of Respiratory Diseases, UZ Leuven and CHROMETA, Research group BREATHE, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Laure-Anne', 'Initials': 'LA', 'LastName': 'Teuwen', 'Affiliation': 'Laboratory of Angiogenesis and Vascular Metabolism, Center for Cancer Biology, VIB, Department of Oncology, Leuven Cancer Institute, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Sebastiaan', 'Initials': 'S', 'LastName': 'Ter Horst', 'Affiliation': 'Laboratory of Virology and Chemotherapy, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Erwin', 'Initials': 'E', 'LastName': 'Dreesen', 'Affiliation': 'Clinical Pharmacology and Pharmacotherapy Unit, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Belgium.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Geukens', 'Affiliation': 'Department of Oncology, Laboratory for Translational Breast Cancer Research, KU Leuven, Belgium.'}, {'ForeName': 'Matthias M', 'Initials': 'MM', 'LastName': 'Engelen', 'Affiliation': 'Department of Cardiovascular Sciences, UZ and KU Leuven, Belgium.'}, {'ForeName': 'Ewout', 'Initials': 'E', 'LastName': 'Landeloos', 'Affiliation': 'Department of Oncology, Laboratory for molecular Cancer biology, VIB-KU Leuven, Belgium.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Geldhof', 'Affiliation': 'Laboratory of Angiogenesis and Vascular Metabolism, Center for Cancer Biology, VIB, Department of Oncology, Leuven Cancer Institute, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Ceunen', 'Affiliation': 'Department of General Internal Medicine, UZ Leuven and Department of Microbiology, Immunology and Transplantation, KU Leuven, Belgium.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Debaveye', 'Affiliation': 'Department of Cardiovascular Sciences, UZ and KU Leuven, Belgium.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Vandenberk', 'Affiliation': 'Department of Cardiovascular Sciences, UZ and KU Leuven, Belgium.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Van der Linden', 'Affiliation': 'Pharmacy Department University Hospitals Leuven and Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Belgium.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Jacobs', 'Affiliation': 'Laboratory of Virology and Chemotherapy, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Lana', 'Initials': 'L', 'LastName': 'Langendries', 'Affiliation': 'Laboratory of Virology and Chemotherapy, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Robbert', 'Initials': 'R', 'LastName': 'Boudewijns', 'Affiliation': 'Laboratory of Virology and Chemotherapy, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Thuc Nguyen Dan', 'Initials': 'TND', 'LastName': 'Do', 'Affiliation': 'Laboratory of Virology and Chemotherapy, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Winston', 'Initials': 'W', 'LastName': 'Chiu', 'Affiliation': 'Laboratory of Virology and Chemotherapy, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Xinyu', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Laboratory of Virology and Chemotherapy, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Laboratory of Virology and Chemotherapy, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Weynand', 'Affiliation': 'Translational Cell and Tissue Research, Department of Imaging and Pathology, KU Leuven, Belgium.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Vanassche', 'Affiliation': 'Department of Cardiovascular Sciences, UZ and KU Leuven, Belgium.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Devos', 'Affiliation': 'Department of Hematology, UZ Leuven and Department of Microbiology, Immunology and Transplantation, Laboratory of Molecular Immunology (Rega Institute), KU Leuven, Belgium.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Meyfroidt', 'Affiliation': 'Department and Laboratory of Intensive Care Medicine, UZ and KU Leuven, Belgium.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Janssens', 'Affiliation': 'Department of Respiratory Diseases, UZ Leuven and CHROMETA, Research group BREATHE, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Vos', 'Affiliation': 'Department of Respiratory Diseases, UZ Leuven and CHROMETA, Research group BREATHE, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Vermeersch', 'Affiliation': 'Department of Cardiovascular Sciences and Clinical Department of Laboratory Medicine, KU Leuven, Belgium.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Wauters', 'Affiliation': 'Medical Intensive Care Unit, UZ Leuven and Department of Microbiology, Immunology and Transplantation, KU Leuven, Belgium.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Verbeke', 'Affiliation': 'KU Leuven - University of Leuven & Universiteit Hasselt, I-BioStat, Leuven, Belgium.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'De Munter', 'Affiliation': 'Department of General Internal Medicine, UZ Leuven and Department of Microbiology, Immunology and Transplantation, KU Leuven, Belgium.'}, {'ForeName': 'Suzanne J F', 'Initials': 'SJF', 'LastName': 'Kaptein', 'Affiliation': 'Laboratory of Virology and Chemotherapy, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Rocha-Pereira', 'Affiliation': 'Laboratory of Virology and Chemotherapy, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Leen', 'Initials': 'L', 'LastName': 'Delang', 'Affiliation': 'Laboratory of Virology and Chemotherapy, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Wijngaerden', 'Affiliation': 'Department of General Internal Medicine, UZ Leuven and Department of Microbiology, Immunology and Transplantation, KU Leuven, Belgium.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Neyts', 'Affiliation': 'Laboratory of Virology and Chemotherapy, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Verhamme', 'Affiliation': 'Department of Cardiovascular Sciences, UZ and KU Leuven, Belgium.'}]",EBioMedicine,['10.1016/j.ebiom.2021.103288'] 2624,33755168,High-Dose vs Standard-Dose Amoxicillin Plus Clavulanate for Adults With Acute Sinusitis: A Randomized Clinical Trial.,"Importance Acute bacterial sinusitis is common, but currently recommended antibiotic treatment provides minimal benefit. Objective To confirm the previous finding that high-dose amoxicillin plus clavulanate (with double the amount of amoxicillin) may be superior to standard-dose amoxicillin plus clavulanate in adults. Design, Setting, and Participants This double-blind, comparative-effectiveness randomized clinical trial was conducted from February 26, 2018, through May 10, 2020, at the academic primary care internal medicine and pediatrics practice of Albany Medical Center, located in Cohoes, New York. Participants included adults aged 18 years or older who were prescribed amoxicillin plus clavulanate for acute bacterial sinusitis diagnosed in accordance with the Infectious Diseases Society of America guidelines. Interventions Amoxicillin 875 mg with clavulanate 125 mg plus either placebo (standard dose) or amoxicillin 875 mg (high dose) twice a day for 7 days. Main Outcomes and Measures The primary efficacy outcome was a global rating of ""a lot better"" or ""no symptoms"" at the end of 3 days of treatment using a Global Rating of Improvement scale, with outcomes ranging from 1 (a lot worse) to 6 (no symptoms). The primary adverse effect outcome was severe diarrhea at 3 or 10 days after the start of treatment. Results At an unplanned interim analysis prompted by COVID-19 restrictions, 157 of a projected 240 participants had been enrolled (mean age, 48.5 [range, 18.7-84.0] years; 117 women [74.5%]), with 79 randomized to the standard dose and 78 to the high dose; 9 and 12, respectively, withdrew or were lost to follow-up before the assessment of the primary outcome. At day 3, 31 of 70 participants (44.3%) in the standard-dose group reported a global rating of ""a lot better"" or ""no symptoms,"" as did 24 of 66 (36.4%) in the high-dose group, for a difference of -7.9% (95% CI, -24.4% to 8.5%; P = .35). The study was, therefore, stopped for futility. Diarrhea was common in both groups by day 3, with any diarrhea reported in 29 of 71 participants (40.8%) receiving the standard dose and 28 of 65 (43.1%) receiving the high dose and severe diarrhea reported in 5 of 71 (7.0%) and 5 of 65 (7.7%), respectively. Conclusions and Relevance The results of this randomized clinical trial suggest that adults treated for clinically diagnosed acute sinusitis did not appear to benefit from taking high-dose compared with standard-dose amoxicillin plus clavulanate. Trial Registration ClinicalTrials.gov Identifier: NCT03431337.",2021,"At day 3, 31 of 70 participants (44.3%) in the standard-dose group reported a global rating of ""a lot better"" or ""no symptoms,"" as did 24 of 66 (36.4%) in the high-dose group, for a difference of -7.9% (95% CI, -24.4% to 8.5%; P = .35).","['240 participants had been enrolled (mean age, 48.5 [range, 18.7-84.0] years; 117 women [74.5%]), with 79 randomized to the standard dose and 78 to the high dose; 9 and 12, respectively, withdrew or were lost to follow-up before the assessment of the primary outcome', 'Participants included adults aged 18 years or older who were prescribed', 'adults', 'adults treated for clinically diagnosed acute sinusitis', 'for acute bacterial sinusitis diagnosed in accordance with the Infectious Diseases Society of America guidelines', 'February 26, 2018, through May 10, 2020, at the academic primary care internal medicine and pediatrics practice of Albany Medical Center, located in Cohoes, New York', 'Adults With Acute Sinusitis']","['amoxicillin plus clavulanate', 'High-Dose vs Standard-Dose Amoxicillin Plus Clavulanate', 'amoxicillin', 'Amoxicillin 875 mg with clavulanate 125 mg plus either placebo']","['global rating of ""a lot better"" or ""no symptoms', 'severe diarrhea', 'Diarrhea', 'global rating of ""a lot better"" or ""no symptoms"" at the end of 3 days of treatment using a Global Rating of Improvement scale', 'diarrhea']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0149512', 'cui_str': 'Acute sinusitis'}, {'cui': 'C0275556', 'cui_str': 'Acute bacterial sinusitis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0002454', 'cui_str': 'America'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0027976', 'cui_str': 'New York'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0110038', 'cui_str': 'Clavulanate'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1124132', 'cui_str': 'Amoxicillin 875 MG'}, {'cui': 'C1126575', 'cui_str': 'Clavulanate 125 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C1443924', 'cui_str': 'Severe diarrhea'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.539069,"At day 3, 31 of 70 participants (44.3%) in the standard-dose group reported a global rating of ""a lot better"" or ""no symptoms,"" as did 24 of 66 (36.4%) in the high-dose group, for a difference of -7.9% (95% CI, -24.4% to 8.5%; P = .35).","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Gregory', 'Affiliation': 'Medicine and Pediatrics, Albany Medical Center Hospital, Cohoes, New York.'}, {'ForeName': 'Bichtram', 'Initials': 'B', 'LastName': 'Huynh', 'Affiliation': 'Medicine and Pediatrics, Albany Medical Center Hospital, Cohoes, New York.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Tayler', 'Affiliation': 'Medicine and Pediatrics, Albany Medical Center Hospital, Cohoes, New York.'}, {'ForeName': 'Chaitali', 'Initials': 'C', 'LastName': 'Korgaonkar-Cherala', 'Affiliation': 'Albany Medical College, Albany, New York.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Garrison', 'Affiliation': 'Department of Pharmacy Practice, Albany College of Pharmacy and Health Sciences, Albany, New York.'}, {'ForeName': 'Ashar', 'Initials': 'A', 'LastName': 'Ata', 'Affiliation': 'Department of Surgery, Albany Medical College, Albany, New York.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sorum', 'Affiliation': 'Department of Internal Medicine, Albany Medical College, Albany, New York.'}]",JAMA network open,['10.1001/jamanetworkopen.2021.2713'] 2625,33755145,"Intensity of statin treatment after acute coronary syndrome, residual risk, and its modification by alirocumab: insights from the ODYSSEY OUTCOMES trial.","AIMS Statins are pivotal to the secondary prevention of major adverse cardiovascular events, but some patients are statin-intolerant. We examined the effects of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor alirocumab on the risk of major adverse cardiovascular events according to the intensity of background statin treatment. METHODS AND RESULTS The ODYSSEY OUTCOMES trial compared alirocumab with placebo in 18,924 patients with acute coronary syndrome and dyslipidaemia despite intensive or maximum-tolerated statin treatment (including no statin if intolerance was documented). The primary outcome (major adverse cardiovascular events) comprised coronary heart disease death, non-fatal myocardial infarction, ischaemic stroke, or unstable angina. Median follow-up was 2.8 years. Baseline statin treatment was high-intensity (88.8%), low/moderate-intensity (8.7%) or none (2.4%). Median baseline low-density lipoprotein cholesterol was 86, 89 and 139 mg/dL (P < 0.001) in these statin treatment categories, respectively. Alirocumab produced similar relative reductions in low-density lipoprotein cholesterol from baseline across statin treatment subgroups, but the mean absolute reductions differed (52.9, 56.7 and 86.1 mg/dL, respectively; P < 0.001). With placebo, the incidence of major adverse cardiovascular events was highest in the no statin subgroup (10.8%, 10.7% and 26.0% respectively). Alirocumab reduced major adverse cardiovascular events in each statin subgroup (hazard ratio 0.88, 95% confidence interval (CI) 0.80-0.96; 0.68, 0.49-0.94; and 0.65, 0.44-0.97, respectively; Pinteraction = 0.14) with a gradient of absolute risk reduction: 1.25%, 95% CI 0.34-2.16; 3.16%, 0.38-5.94; 7.97%, 0.42-15.51; Pinteraction = 0.106). CONCLUSIONS PCSK9 inhibition with alirocumab reduces the relative risk of major adverse cardiovascular events after acute coronary syndrome irrespective of background statin treatment. However, patients on no statin are at high absolute risk for recurrent major adverse cardiovascular events; alirocumab substantially reduces that risk. PCSK9 inhibition may be an important therapeutic strategy for statin-intolerant patients with acute coronary syndrome.",2021,"Alirocumab reduced major adverse cardiovascular events in each statin subgroup (hazard ratio 0.88, 95% confidence interval (CI) 0.80-0.96; 0.68, 0.49-0.94; and 0.65, 0.44-0.97, respectively; Pinteraction = 0.14) with a gradient of absolute risk reduction: 1.25%, 95% CI 0.34-2.16; 3.16%, 0.38-5.94; 7.97%, 0.42-15.51; Pinteraction = 0.106). ","['18,924 patients with acute coronary syndrome and dyslipidaemia despite intensive or maximum-tolerated statin treatment (including no statin if intolerance was documented', 'statin-intolerant patients with acute coronary syndrome']","['Alirocumab', 'alirocumab with placebo', 'placebo', 'proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor alirocumab', 'alirocumab']","['low-density lipoprotein cholesterol', 'primary outcome (major adverse cardiovascular events) comprised coronary heart disease death, non-fatal myocardial infarction, ischaemic stroke, or unstable angina', 'major adverse cardiovascular events', 'relative risk of major adverse cardiovascular events', 'Median baseline low-density lipoprotein cholesterol', 'incidence of major adverse cardiovascular events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C1301725', 'cui_str': 'Documented'}]","[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1174937', 'cui_str': 'PCSK9 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",18924.0,0.235978,"Alirocumab reduced major adverse cardiovascular events in each statin subgroup (hazard ratio 0.88, 95% confidence interval (CI) 0.80-0.96; 0.68, 0.49-0.94; and 0.65, 0.44-0.97, respectively; Pinteraction = 0.14) with a gradient of absolute risk reduction: 1.25%, 95% CI 0.34-2.16; 3.16%, 0.38-5.94; 7.97%, 0.42-15.51; Pinteraction = 0.106). ","[{'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Clínicos Latino América, Instituto Cardiovascular de Rosario, Argentina.'}, {'ForeName': 'Qian H', 'Initials': 'QH', 'LastName': 'Li', 'Affiliation': 'Regeneron Pharmaceuticals Inc., Tarrytown, USA.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, USA.""}, {'ForeName': 'Vera A', 'Initials': 'VA', 'LastName': 'Bittner', 'Affiliation': 'Division of Cardiovascular Disease, University of Alabama at Birmingham, USA.'}, {'ForeName': 'Marie T', 'Initials': 'MT', 'LastName': 'Baccara-Dinet', 'Affiliation': 'Sanofi R&D, Montpellier, France.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Canada.'}, {'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Kyoto University, Graduate School of Medicine, Japan.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Parkhomenko', 'Affiliation': 'MD Strazhesko Institute of Cardiology, AMS of Ukraine, Ukraine.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pordy', 'Affiliation': 'Regeneron Pharmaceuticals Inc., Tarrytown, USA.'}, {'ForeName': 'Željko', 'Initials': 'Ž', 'LastName': 'Reiner', 'Affiliation': 'University Hospital Center Zagreb, University of Zagreb, Croatia.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Roe', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Szarek', 'Affiliation': 'State University of New York, Downstate School of Public Health, USA.'}, {'ForeName': 'Hung-Fat', 'Initials': 'HF', 'LastName': 'Tse', 'Affiliation': ""Queen Mary Hospital, Hong Kong, Special Administrative Region of the People's Republic of China.""}, {'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Green Lane Cardiovascular Services, Auckland City Hospital, New Zealand.'}, {'ForeName': 'Doron', 'Initials': 'D', 'LastName': 'Zahger', 'Affiliation': 'Soroka University Medical Center, Ben Gurion University of the Negev, Israel.'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Zeiher', 'Affiliation': 'Department of Medicine III, Goethe University, Germany.'}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Schwartz', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, USA.'}, {'ForeName': 'Ph Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Université de Paris, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, FACT (French Alliance for Cardiovascular Trials), and INSERM, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of preventive cardiology,['10.1177/2047487320941987'] 2626,33755143,Effects of linagliptin on left ventricular DYsfunction in patients with type 2 DiAbetes and concentric left ventricular geometry: results of the DYDA 2 trial.,"AIMS To evaluate the effect of linagliptin on left ventricular systolic function beyond glycaemic control in type 2 diabetes mellitus. METHODS AND RESULTS A multicentre, randomised, double-blind, placebo controlled, parallel-group study, was performed (the DYDA 2 trial). Individuals with type 2 diabetes mellitus and asymptomatic impaired left ventricular systolic function were randomly allocated in a 1:1 ratio to receive for 48 weeks either linagliptin 5 mg daily or placebo, in addition to their diabetes therapy. Eligibility criteria were age 40 years and older, haemoglobin A1c 8.0% or less (≤64 mmol/mol), no history of cardiac disease, concentric left ventricular geometry (relative wall thickness ≥0.42), impaired left ventricular systolic function defined as midwall fractional shortening 15% or less at baseline echocardiography. The primary end point was the modification of midwall fractional shortening over time. The main secondary objectives were changes in diastolic and/or in longitudinal left ventricular systolic function as measured by tissue Doppler echocardiography. One hundred and eighty-eight patients were enrolled, predominantly men with typical insulin-resistance comorbidities. At baseline, mean midwall fractional shortening was 13.3%±2.5. At final evaluation, 88 linagliptin patients and 86 placebo patients were compared: midwall fractional shortening increased from 13.29 to 13.82 (+4.1%) in the linagliptin group, from 13.58 to 13.84 in the placebo group (+1.8%, analysis of covariance P = 0.86), corresponding to a 2.3-fold higher increase in linagliptin than the placebo group, although non-statistically significant. Also, changes in diastolic and longitudinal left ventricular systolic function did not differ between the groups. Serious adverse events or linagliptin/placebo permanent discontinuation occurred in very few cases and in the same percentage between the groups. CONCLUSIONS In the DYDA 2 patients the addition of linagliptin to stable diabetes therapy was safe and provided a modest non-significant increase in left ventricular systolic function measured as midwall fractional shortening. TRIAL REGISTRATION NUMBER ClinicalTrial.gov (ID NCT02851745).",2021,"Serious adverse events or linagliptin/placebo permanent discontinuation occurred in very few cases and in the same percentage between the groups. ","['patients with type 2 DiAbetes and concentric left ventricular geometry', 'Eligibility criteria were age 40 years and older, haemoglobin A1c 8.0% or less (≤64 mmol/mol), no history of cardiac disease, concentric left ventricular geometry (relative wall thickness', 'One hundred and eighty-eight patients were enrolled, predominantly men with typical insulin-resistance comorbidities', 'Individuals with type 2 diabetes mellitus and asymptomatic impaired left ventricular systolic function', 'type 2 diabetes mellitus']","['linagliptin/placebo', 'placebo', 'linagliptin', 'linagliptin 5\u2009mg daily or placebo']","['left ventricular systolic function', 'midwall fractional shortening', 'mean midwall fractional shortening', 'left ventricular DYsfunction', 'modification of midwall fractional shortening over time', 'impaired left ventricular systolic function', 'changes in diastolic and longitudinal left ventricular systolic function', 'changes in diastolic and/or in longitudinal left ventricular systolic function as measured by tissue Doppler echocardiography']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0449829', 'cui_str': 'Geometry'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3153993', 'cui_str': 'Linagliptin 5 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0242698', 'cui_str': 'Impaired left ventricular function'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}]",188.0,0.176934,"Serious adverse events or linagliptin/placebo permanent discontinuation occurred in very few cases and in the same percentage between the groups. ","[{'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Cioffi', 'Affiliation': 'Division of Rheumatology, University and Azienda Ospedaliera Universitaria Integrata of Verona, Italy.'}, {'ForeName': 'Carlo Bruno', 'Initials': 'CB', 'LastName': 'Giorda', 'Affiliation': 'Metabolism and Diabetes Unit, ASL Torino 5, Italy.'}, {'ForeName': 'Donata', 'Initials': 'D', 'LastName': 'Lucci', 'Affiliation': 'ANMCO Research Center, Heart Care Foundation, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Nada', 'Affiliation': 'Metabolism and Diabetes Unit, ASL Torino 5, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Ognibeni', 'Affiliation': 'Division of Rheumatology, University and Azienda Ospedaliera Universitaria Integrata of Verona, Italy.'}, {'ForeName': 'Costantino', 'Initials': 'C', 'LastName': 'Mancusi', 'Affiliation': 'Hypertension Research Center, Federico II University, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Latini', 'Affiliation': 'Department of Cardiovascular Research, IRCCS Istituto di Ricerche Farmacologiche ""Mario Negri"", Italy.'}, {'ForeName': 'Aldo P', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': 'ANMCO Research Center, Heart Care Foundation, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of preventive cardiology,['10.1177/2047487320939217'] 2627,33760360,A machine learning-based survival prediction model of high grade glioma by integration of clinical and dose-volume histogram parameters.,"PURPOSE Glioma is the most common type of primary brain tumor in adults, and it causes significant morbidity and mortality, especially in high-grade glioma (HGG) patients. The accurate prognostic prediction of HGG is vital and helpful for clinicians when developing therapeutic strategies. Therefore, we propose a machine learning-based survival prediction model by analyzing clinical and dose-volume histogram (DVH) parameters, to improve the performance of the risk model in HGG patients. METHODS Eight clinical variables and 39 DVH parameters were extracted for each patient, who received radiotherapy for HGG with active follow-up. Ninety-five patients were randomly divided into training and testing cohorts, and we employed random survival forest (RSF), support vector machine (SVM), and Cox proportional hazards (CPHs) models to predict survival. Calibration plots, concordance indexes, and decision curve analyses were used to evaluate the calibration, discrimination, and clinical utility of these three models. RESULTS The RSF model showed the best performance among the three models, with concordance indexes of 0.824 and 0.847 in the training and testing sets, respectively, followed by the SVM (0.792/0.823) and CPH (0.821/0.811) models. Specifically, in the RSF model, we identified age, gross tumor volume (GTV), grade, Karnofsky performance status (KPS), isocitrate dehydrogenase (IDH), and D99 as important variables associated with survival. The AUCs of the testing set were 92.4%, 87.7%, and 84.0% for 1-, 2-, and 3-year survival, respectively. According to this model, HGG patients can be divided into high- and low-risk groups. CONCLUSION The machine learning-based RSF model integrating both clinical and DVH variables is an improved and useful tool for predicting the survival of HGG patients.",2021,"The RSF model showed the best performance among the three models, with concordance indexes of 0.824 and 0.847 in the training and testing sets, respectively, followed by the SVM (0.792/0.823) and CPH (0.821/0.811) models.","['Eight clinical variables and 39 DVH parameters were extracted for each patient, who received radiotherapy for HGG with active follow-up', 'HGG patients', 'Ninety-five patients']",[],"['3-year survival', 'gross tumor volume (GTV), grade, Karnofsky performance status (KPS), isocitrate dehydrogenase (IDH), and D99 as important variables associated with survival']","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0555198', 'cui_str': 'Glioma, malignant, no ICD-O subtype'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517906', 'cui_str': '95'}]",[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0475645', 'cui_str': 'Gross tumor volume'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky performance status'}, {'cui': 'C0022157', 'cui_str': 'Isocitrate dehydrogenase'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]",95.0,0.027649,"The RSF model showed the best performance among the three models, with concordance indexes of 0.824 and 0.847 in the training and testing sets, respectively, followed by the SVM (0.792/0.823) and CPH (0.821/0.811) models.","[{'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, Key Laboratory of Cancer Prevention and Intervention, Ministry of Education, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Radiation Oncology, Key Laboratory of Cancer Prevention and Intervention, Ministry of Education, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': 'Department of Radiation Oncology, Key Laboratory of Cancer Prevention and Intervention, Ministry of Education, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'Zhejiang University Cancer Center, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Yanlin', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'College of Science, Hangzhou Normal University, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Qichun', 'Initials': 'Q', 'LastName': 'Wei', 'Affiliation': 'Department of Radiation Oncology, Key Laboratory of Cancer Prevention and Intervention, Ministry of Education, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.'}]",Cancer medicine,['10.1002/cam4.3838'] 2628,33760089,Effect of Behaviorally Designed Gamification With a Social Support Partner to Increase Mobility After Hospital Discharge: A Randomized Clinical Trial.,"Importance Hospitalization is associated with decreased mobility and functional decline. Behaviorally designed gamification can increase mobility in community settings but has not been tested among patients at risk for functional decline during a high-risk transition period after hospitalization. Objective To test a behaviorally designed gamification intervention with a social support partner to increase patient mobility after hospital discharge. Design, Setting, and Participants This study is a randomized clinical trial of a 12-week intervention without follow-up. Enrollment occurred from January 2018 to June 2019 at a referral hospital with a remote at-home monitoring intervention among patients living predominantly in 3 states (Pennsylvania, New Jersey, and Delaware). Participants included adult patients discharged from general medicine and oncology units to home. Data analysis was performed from October 2019 to March 2020. Interventions All participants received a wearable device to track daily steps. The control group received feedback from the device but no other interventions. The intervention group entered into a 12-week game informed by behavioral economics to assign points and levels for achieving step goals and reinforced by a support partner who received updates on participant progress. Main Outcomes and Measures The primary outcome was change in mean daily steps from baseline through the 12-week intervention. Secondary measures were change in functional status and urgent care utilization (ie, emergency department visits and hospital readmissions) within this period. Results A total of 232 participants were enrolled in the study (118 randomized to control and 114 randomized to the intervention). Participants had a mean (SD) age of 40 (14) years, 141 (61%) were female, 101 (43%) were White, and 103 (44%) had an annual household income less than $50 000. Daily step counts increased from 3795 to 4652 steps (difference, 857 steps; 95% CI, 488 to 1224 steps) among intervention participants and increased from 3951 to 4499 steps (difference, 548 steps; 95% CI, 193 to 903 steps) among control participants. The change in mean daily step count from baseline was not significantly different for participants in the intervention group vs the control group (adjusted difference, 270 steps; 95% CI, -214 to 754 steps; P = .27). Among the subgroup of 76 participants with higher levels of social engagement, post hoc exploratory analyses showed a significant increase in mobility for intervention vs control (adjusted difference, 1125 steps; 95% CI, 409 to 1841 steps; P = .002). Fewer participants in this subgroup experienced functional decline (1 of 36 participants [4%] in the intervention group vs 5 of 40 participants [12%] in the control group) and hospital readmission at 30 days (3 of 36 participants [8%] in the intervention group vs 6 of 40 participants [15%] in the control group), but the differences were not statistically significant. There were no significant differences in these secondary outcomes for the overall sample. Conclusions and Relevance Gamification with social incentives did not affect mobility or functional decline in all participants, but post hoc analysis suggests positive findings for both outcomes for patients with higher social engagement. Trial Registration ClinicalTrials.gov Identifier: NCT03321279.",2021,"The change in mean daily step count from baseline was not significantly different for participants in the intervention group vs the control group (adjusted difference, 270 steps; 95% CI, -214 to 754 steps; P = .27).","['patients with higher social engagement', 'Participants had a mean (SD) age of 40 (14) years, 141 (61%) were female, 101 (43%) were White, and 103 (44%) had an annual household income', 'A total of 232 participants were enrolled in the study (118 randomized to control and 114 randomized to the intervention', 'Enrollment occurred from January 2018 to June 2019 at a referral hospital with a remote at-home monitoring intervention among patients living predominantly in 3 states (Pennsylvania, New Jersey, and Delaware', 'patients at risk for functional decline during a high-risk transition period after hospitalization', 'Participants included adult patients discharged from general medicine and oncology units to home']",['12-week game informed by behavioral economics to assign points and levels for achieving step goals and reinforced by a support partner who received updates on participant progress'],"['mobility and functional decline', 'functional decline', 'change in functional status and urgent care utilization (ie, emergency department visits and hospital readmissions', 'change in mean daily steps', 'social engagement', 'mobility', 'hospital readmission', 'Mobility', 'mean daily step count', 'Daily step counts']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0557163', 'cui_str': 'Household income'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0027971', 'cui_str': 'New Jersey'}, {'cui': 'C0011198', 'cui_str': 'Delaware'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0086343', 'cui_str': 'General medicine'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C2362545', 'cui_str': 'Urgent Care'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",232.0,0.314366,"The change in mean daily step count from baseline was not significantly different for participants in the intervention group vs the control group (adjusted difference, 270 steps; 95% CI, -214 to 754 steps; P = .27).","[{'ForeName': 'S Ryan', 'Initials': 'SR', 'LastName': 'Greysen', 'Affiliation': 'Section of Hospital Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia.'}, {'ForeName': 'Sujatha', 'Initials': 'S', 'LastName': 'Changolkar', 'Affiliation': 'University of Michigan School of Medicine, Ann Arbor.'}, {'ForeName': 'Dylan S', 'Initials': 'DS', 'LastName': 'Small', 'Affiliation': 'The Wharton School, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Reale', 'Affiliation': 'University of Michigan School of Medicine, Ann Arbor.'}, {'ForeName': 'Charles A L', 'Initials': 'CAL', 'LastName': 'Rareshide', 'Affiliation': 'University of Michigan School of Medicine, Ann Arbor.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Mercede', 'Affiliation': 'University of Michigan School of Medicine, Ann Arbor.'}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Snider', 'Affiliation': 'The Wharton School, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Greysen', 'Affiliation': 'Crescenz Veterans Affairs Medical Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Trotta', 'Affiliation': 'University of Pennsylvania School of Nursing, Philadelphia.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Halpern', 'Affiliation': 'Palliative and Advanced Illness Research Center, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Mitesh S', 'Initials': 'MS', 'LastName': 'Patel', 'Affiliation': 'University of Michigan School of Medicine, Ann Arbor.'}]",JAMA network open,['10.1001/jamanetworkopen.2021.0952'] 2629,33758387,Neurodevelopmental outcome of preterm infants enrolled in myo-inositol randomized controlled trial.,"OBJECTIVE This study evaluates the 24-month follow-up for the NICHD Neonatal Research Network (NRN) Inositol for Retinopathy Trial. STUDY DESIGN Bayley Scales of Infants Development-III and a standardized neurosensory examination were performed in infants enrolled in the main trial. Moderate/severe NDI was defined as BSID-III Cognitive or Motor composite score <85, moderate or severe cerebral palsy, blindness, or hearing loss that prevents communication despite amplification were assessed. RESULTS Primary outcome was determined for 605/638 (95%). The mean gestational age was 25.8 ± 1.3 weeks and mean birthweight was 805 ± 192 g. Treatment group did not affect the risk for the composite outcome of death or survival with moderate/severe NDI (60% vs 56%, p = 0.40). CONCLUSIONS Treatment group did not affect the risk of death or survival with moderate/severe NDI. Despite early termination, this study represents the largest RCT of extremely preterm infants treated with myo-inositol with neurodevelopmental outcome data.",2021,"The mean gestational age was 25.8 ± 1.3 weeks and mean birthweight was 805 ± 192 g. Treatment group did not affect the risk for the composite outcome of death or survival with moderate/severe NDI (60% vs 56%, p = 0.40). ","['Bayley Scales of Infants Development-III and a standardized neurosensory examination were performed in infants enrolled in the main trial', 'preterm infants enrolled in myo-inositol randomized controlled trial']",[],"['mean gestational age', 'BSID-III Cognitive or Motor composite score <85, moderate or severe cerebral palsy, blindness, or hearing loss', 'Moderate/severe NDI', 'risk of death or survival', 'death or survival with moderate/severe NDI']","[{'cui': 'C0451021', 'cui_str': 'Bayley scale of infant development'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0021547', 'cui_str': 'Inositol'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C1563705', 'cui_str': 'Diabetes Insipidus, Nephrogenic, Type I'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.283315,"The mean gestational age was 25.8 ± 1.3 weeks and mean birthweight was 805 ± 192 g. Treatment group did not affect the risk for the composite outcome of death or survival with moderate/severe NDI (60% vs 56%, p = 0.40). ","[{'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Adams-Chapman', 'Affiliation': ""Department of Pediatrics, Emory University School of Medicine and Children's Healthcare of Atlanta, Atlanta, GA, USA.""}, {'ForeName': 'Kristi L', 'Initials': 'KL', 'LastName': 'Watterberg', 'Affiliation': 'University of New Mexico Health Sciences Center, Albuquerque, NM, USA.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Nolen', 'Affiliation': 'Social, Statistical and Environmental Sciences Unit, RTI International, Research Triangle Park, North Carolina, NC, USA.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Hirsch', 'Affiliation': 'Social, Statistical and Environmental Sciences Unit, RTI International, Research Triangle Park, North Carolina, NC, USA.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Cole', 'Affiliation': 'University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.'}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Cotten', 'Affiliation': 'Department of Pediatrics, Duke University, Durham, NC, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Oh', 'Affiliation': ""Department of Pediatrics, Women & Infants' Hospital, Brown University, Providence, RI, USA.""}, {'ForeName': 'Brenda B', 'Initials': 'BB', 'LastName': 'Poindexter', 'Affiliation': ""Department of Pediatrics, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, OH, USA.""}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Zaterka-Baxter', 'Affiliation': 'Social, Statistical and Environmental Sciences Unit, RTI International, Research Triangle Park, North Carolina, NC, USA.'}, {'ForeName': 'Abhik', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Social, Statistical and Environmental Sciences Unit, RTI International, Rockville, MD, USA.'}, {'ForeName': 'Conra Backstrom', 'Initials': 'CB', 'LastName': 'Lacy', 'Affiliation': 'University of New Mexico Health Sciences Center, Albuquerque, NM, USA.'}, {'ForeName': 'Ann Marie', 'Initials': 'AM', 'LastName': 'Scorsone', 'Affiliation': 'University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.'}, {'ForeName': 'Andrea F', 'Initials': 'AF', 'LastName': 'Duncan', 'Affiliation': 'Department of Pediatrics, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Sara B', 'Initials': 'SB', 'LastName': 'DeMauro', 'Affiliation': ""Department of Pediatrics, The Children's Hospital of Philadelphia and The University of Pennsylvania, Philadelphia, PA, USA.""}, {'ForeName': 'Ricki F', 'Initials': 'RF', 'LastName': 'Goldstein', 'Affiliation': 'Department of Pediatrics, Duke University, Durham, NC, USA.'}, {'ForeName': 'Tarah T', 'Initials': 'TT', 'LastName': 'Colaizy', 'Affiliation': 'Department of Pediatrics, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Deanne E', 'Initials': 'DE', 'LastName': 'Wilson-Costello', 'Affiliation': ""Department of Pediatrics, Rainbow Babies & Children's Hospital, Case Western Reserve University, Cleveland, OH, USA.""}, {'ForeName': 'Isabell B', 'Initials': 'IB', 'LastName': 'Purdy', 'Affiliation': 'Department of Pediatrics, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Hintz', 'Affiliation': ""Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto, CA, USA.""}, {'ForeName': 'Roy J', 'Initials': 'RJ', 'LastName': 'Heyne', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Myers', 'Affiliation': 'University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.'}, {'ForeName': 'Janell', 'Initials': 'J', 'LastName': 'Fuller', 'Affiliation': 'University of New Mexico Health Sciences Center, Albuquerque, NM, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Merhar', 'Affiliation': ""Department of Pediatrics, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, OH, USA.""}, {'ForeName': 'Heidi M', 'Initials': 'HM', 'LastName': 'Harmon', 'Affiliation': 'Department of Pediatrics, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Peralta-Carcelen', 'Affiliation': 'Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Howard W', 'Initials': 'HW', 'LastName': 'Kilbride', 'Affiliation': ""Department of Pediatrics, Children's Mercy Hospital and University of Missouri Kansas City School of Medicine, Kansas City, MO, USA.""}, {'ForeName': 'Nathalie L', 'Initials': 'NL', 'LastName': 'Maitre', 'Affiliation': ""Department of Pediatrics, Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, OH, USA.""}, {'ForeName': 'Betty R', 'Initials': 'BR', 'LastName': 'Vohr', 'Affiliation': ""Department of Pediatrics, Women & Infants' Hospital, Brown University, Providence, RI, USA.""}, {'ForeName': 'Girija', 'Initials': 'G', 'LastName': 'Natarajan', 'Affiliation': 'Department of Pediatrics, Wayne State University, Detroit, MI, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Mintz-Hittner', 'Affiliation': 'Department of Ophthalmology and Visual Science, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Graham E', 'Initials': 'GE', 'LastName': 'Quinn', 'Affiliation': ""Department of Ophthalmology, The Children's Hospital of Philadelphia and The University of Pennsylvania, Philadelphia, PA, USA.""}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Wallace', 'Affiliation': 'Department of Ophthalmology, Duke University, Durham, NC, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Olson', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Faruk H', 'Initials': 'FH', 'LastName': 'Orge', 'Affiliation': ""Department of Ophthalmology, Rainbow Babies & Children's Hospital, Case Western Reserve University, Cleveland, OH, USA.""}, {'ForeName': 'Irena', 'Initials': 'I', 'LastName': 'Tsui', 'Affiliation': 'Department of Ophthalmology, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gaynon', 'Affiliation': ""Department of Ophthalmology, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto, CA, USA.""}, {'ForeName': 'Amy K', 'Initials': 'AK', 'LastName': 'Hutchinson', 'Affiliation': ""Department of Ophthalmology, Emory University School of Medicine and Children's Healthcare of Atlanta, Atlanta, GA, USA.""}, {'ForeName': 'Yu-Guang', 'Initials': 'YG', 'LastName': 'He', 'Affiliation': 'Department of Ophthalmology, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Winter', 'Affiliation': 'Division of Ophthalmology/Department of Surgery, University of New Mexico Health Sciences Center, Albuquerque, NM, USA.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Yang', 'Affiliation': ""Department of Ophthalmology, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, OH, USA.""}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Haider', 'Affiliation': 'Department of Ophthalmology, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Martin S', 'Initials': 'MS', 'LastName': 'Cogen', 'Affiliation': 'Department of Ophthalmology, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Hug', 'Affiliation': ""Department of Ophthalmology, Children's Mercy Hospital and University of Missouri Kansas City School of Medicine, Kansas City, MO, USA.""}, {'ForeName': 'Don L', 'Initials': 'DL', 'LastName': 'Bremer', 'Affiliation': ""Department of Ophthalmology, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Donahue', 'Affiliation': 'Alpert Medical School of Brown University and Consulting Staff, Women & Infants Hospital of Rhode Island, Providence, RI, USA.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Lucas', 'Affiliation': 'Department of Ophthalmology, Wayne State University, Detroit, MI, USA.'}, {'ForeName': 'Dale L', 'Initials': 'DL', 'LastName': 'Phelps', 'Affiliation': 'University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.'}, {'ForeName': 'Rosemary D', 'Initials': 'RD', 'LastName': 'Higgins', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA. rhiggin@gmu.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-021-01018-5'] 2630,33756376,Subgroups of comorbid PTSD and AUD in U.S. military veterans predict differential responsiveness to two integrated treatments: A latent class analysis.,"Posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) frequently co-occur. Integrated treatments are effective, but not all patients respond and predicting outcome remains difficult. In this study, latent class analysis (LCA) identified symptom-based subgroups of comorbid PTSD/AUD among 119 veterans with PTSD/AUD from a randomized controlled trial of integrated exposure therapy (I-PE) versus integrated coping skills therapy (I-CS). Multilevel models compared subgroups on PTSD severity and percentage of heavy drinking days at post-treatment and 3- and 6-month follow-up. LCA revealed three subgroups best fit the data: Moderate PTSD/Low AUD Impairment (21%), High PTSD/High AUD Impairment (48%), and Low PTSD/High AUD Impairment (31%). There was a three-way interaction between time, treatment condition, and subgroup in predicting PTSD outcomes (p < .05). For the Moderate PTSD/Low AUD Impairment class, outcomes at post-treatment and 3-months were similar (ds = 0.17, 0.55), however I-PE showed greater reductions at 6-months (d = 1.36). For the High PTSD/High AUD Impairment class, I-PE demonstrated better post-treatment (d = 0.83) but comparable follow-up (ds = -0.18, 0.49) outcomes. For the Low PTSD/High AUD Impairment class, I-PE demonstrated stronger outcomes at every timepoint (ds = 0.82-1.15). Heavy drinking days declined significantly through follow-up, with an effect of subgroup, but not treatment, on timing of response. This was the first study modeling how PTSD and AUD symptoms might cluster together in a treatment sample of veterans with PTSD/AUD. Symptom-based subgroups show promise in helping understand variability in treatment response among patients with PTSD/AUD and deserve further study.",2021,"Heavy drinking days declined significantly through follow-up, with an effect of subgroup, but not treatment, on timing of response.","['patients with PTSD/AUD', 'veterans with PTSD/AUD', '119 veterans with PTSD/AUD']","['integrated exposure therapy (I-PE) versus integrated coping skills therapy (I-CS', 'LCA']",['Heavy drinking days'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}]","[{'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4704739', 'cui_str': 'Latent Variable Modeling'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}]",,0.0284902,"Heavy drinking days declined significantly through follow-up, with an effect of subgroup, but not treatment, on timing of response.","[{'ForeName': 'Kaitlyn E', 'Initials': 'KE', 'LastName': 'Panza', 'Affiliation': 'VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA, 92161, USA; Department of Psychiatry, University of California San Diego, 9500 Gilman Drive, La Jolla, CA, 92093, USA. Electronic address: kaitlyn.panza@gmail.com.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Kline', 'Affiliation': 'VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA, 92161, USA; Department of Psychiatry, University of California San Diego, 9500 Gilman Drive, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Norman', 'Affiliation': 'Department of Family Medicine and Public Health, University of California San Diego, 9500 Gilman Drive, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Pitts', 'Affiliation': 'VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA, 92161, USA.'}, {'ForeName': 'Sonya B', 'Initials': 'SB', 'LastName': 'Norman', 'Affiliation': 'VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA, 92161, USA; Department of Psychiatry, University of California San Diego, 9500 Gilman Drive, La Jolla, CA, 92093, USA; National Center for Posttraumatic Stress Disorder, 163 Veterans Drive, White River Junction, VT, 05009, USA.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2021.02.061'] 2631,33756279,The relation between the flexion relaxation phenomenon onset angle and lumbar spine muscle reflex onset time in response to 30 min of slumped sitting.,"Viscoelastic creep of spine tissue, induced by submaximal spine flexion in sitting, can delay the onset of the flexion-relaxation phenomenon (FRP) and low back reflexes (LBR). Theoretically, these two outcome measures should be correlated; however, no studies have investigated this. This study aims to determine whether 30 min of near-maximal spine flexion will affect the onset of FRP and LBR in the lumbar erector spinae (LS) and lumbar multifidus (LM), and to examine the relation between these parameters. 15 participants were recruited (9F, 6M). Spine angle (between L1 and S2) was monitored synchronously with bilateral muscle activity in the LS (L1) and the LM (L4). FRP onset and LBR were measured in a randomized order before and after 30 min of slouched sitting. No significant difference was found for any muscle LBR onset time between pre and post-sitting (p > 0.05). A significant increase in FRP onset was found in the RLM (p = 0.016) following sitting. No significant correlation was found between the FRP and the LBR for any muscle. These results suggest that the LBR onset might not be as sensitive as an outcome measure to investigate shorter exposures of sitting as FRP.",2021,A significant increase in FRP onset was found in the RLM (p = 0.016) following sitting.,"['15 participants were recruited (9F, 6M']",['30\xa0min of near-maximal spine flexion'],"['FRP onset and LBR', 'FRP onset', 'muscle LBR onset time']",[],"[{'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}]","[{'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}]",15.0,0.0269414,A significant increase in FRP onset was found in the RLM (p = 0.016) following sitting.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mackey', 'Affiliation': ""School of Human Kinetics and Recreation, Memorial University of Newfoundland, St. John's NL, Canada.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Barnes', 'Affiliation': ""School of Human Kinetics and Recreation, Memorial University of Newfoundland, St. John's NL, Canada.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Pike', 'Affiliation': ""School of Human Kinetics and Recreation, Memorial University of Newfoundland, St. John's NL, Canada.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'De Carvalho', 'Affiliation': ""Faculty of Medicine, Memorial University of Newfoundland, St. John's NL, Canada. Electronic address: ddecarvalho@mun.ca.""}]",Journal of electromyography and kinesiology : official journal of the International Society of Electrophysiological Kinesiology,['10.1016/j.jelekin.2021.102545'] 2632,33756252,Program for attention rehabilitation and strengthening (PARS) improves executive functions in children with attention deficit- hyperactivity disorder (ADHD).,"Attention is improved through cognitive rehabilitation. The purpose of the present study was the evaluation of the effect of a paper and pencil program for attention rehabilitation and strengthening (PARS) in children with ADHD. Thirty children with ADHD were randomly divided into two equal intervention and control groups. The intervention group received 12-15 sessions of intervention through PARS. Sustained, selective, and shifting attention, inhibitory control, and working memory were assessed by Persian attention registration, Stroop, color trail making, Go/No-Go, and 1- back tests. Analyses indicated that the experimental group, in comparison with the control group, showed improved selective and sustained attention and the training effects transfers to executive functions, inhibitory control and working memory. The result is discussed in the light of transferability of training effects from attention to executive functions.",2021,"Analyses indicated that the experimental group, in comparison with the control group, showed improved selective and sustained attention and the training effects transfers to executive functions, inhibitory control and working memory.","['children with attention deficit- hyperactivity disorder (ADHD', 'Thirty children with ADHD', 'children with ADHD']","['Program for attention rehabilitation and strengthening (PARS', '12-15 sessions of intervention through PARS', 'paper and pencil program for attention rehabilitation and strengthening (PARS']","['Sustained, selective, and shifting attention, inhibitory control, and working memory were assessed by Persian attention registration, Stroop, color trail making, Go/No-Go, and 1- back tests', 'executive functions', 'selective and sustained attention and the training effects transfers to executive functions, inhibitory control and working memory']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0441059', 'cui_str': 'Pencil'}]","[{'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0031188', 'cui_str': 'Persian language'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",30.0,0.00192258,"Analyses indicated that the experimental group, in comparison with the control group, showed improved selective and sustained attention and the training effects transfers to executive functions, inhibitory control and working memory.","[{'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Nejati', 'Affiliation': 'Department of Psychology, Shahid Beheshti University, PO Box: 1983969411, Tehran, Iran. Electronic address: nejati@sbu.ac.ir.'}]",Research in developmental disabilities,['10.1016/j.ridd.2021.103937'] 2633,33769463,Patterns of Translocation Testing in Patients Enrolling to a Cooperative Group Trial for Newly Diagnosed Metastatic Ewing Sarcoma: A Report From the Children's Oncology Group.,"CONTEXT.— Molecular diagnostics play an increasing role in the diagnosis of Ewing sarcoma. The type of molecular testing used in clinical practice has been poorly described. OBJECTIVE.— To describe patterns of translocation testing for newly diagnosed Ewing sarcoma. DESIGN.— Children's Oncology Group (COG) trial AEWS1221 was a phase III randomized trial enrolling patients with newly diagnosed metastatic Ewing sarcoma from 2014 to 2019. Patients were required to have a histologic diagnosis of Ewing sarcoma, but translocation testing was not required. Sites provided types and results of any molecular diagnostics performed. RESULTS.— Data from 305 enrolled patients were available. The most common type of molecular testing was fluorescence in situ hybridization (FISH) performed on the primary tumor (236 of 305 patients; 77.4%), with positive testing for an EWSR1 or FUS translocation in 211 (89.4%). Reverse transcription-polymerase chain reaction (RT-PCR) on the primary tumor was performed in 61 of 305 (20%), with positive results in 48 of 61 patients (78.7%). Next-generation sequencing was reported in 7 patients on primary tumor and in 3 patients on metastatic sites. Evaluating all types of testing on either primary or metastatic tumor, 16 of 305 patients (5.2%) had no reported translocation testing. Evaluating all results from all testing, 44 of 305 patients (14.4%) lacked documentation of an abnormality consistent with a molecular diagnosis of Ewing sarcoma. CONCLUSIONS.— COG sites enrolling in a Ewing sarcoma trial have high rates of testing by FISH or PCR. A small proportion of patients have no translocation testing on either primary or metastatic sites. Next-generation sequencing techniques are not yet commonly used in this context.",2021,"Evaluating all results from all testing, 44 of 305 patients (14.4%) lacked documentation of an abnormality consistent with a molecular diagnosis of Ewing sarcoma. ","['Patients Enrolling to a Cooperative Group Trial for Newly Diagnosed Metastatic Ewing Sarcoma', ""Children's Oncology Group (COG) trial AEWS1221 was a phase III randomized trial enrolling patients with newly diagnosed metastatic Ewing sarcoma from 2014 to 2019"", 'newly diagnosed Ewing sarcoma', '305 enrolled patients were available']",[],"['Reverse transcription-polymerase chain reaction (RT-PCR', 'histologic diagnosis of Ewing sarcoma']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]",[],"[{'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma'}]",305.0,0.137249,"Evaluating all results from all testing, 44 of 305 patients (14.4%) lacked documentation of an abnormality consistent with a molecular diagnosis of Ewing sarcoma. ","[{'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'DuBois', 'Affiliation': ""From Dana-Farber/Boston Children's Cancer and Blood Disorders Center, Harvard Medical School, Boston, Massachusetts (DuBois, Crompton, Janeway).""}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Krailo', 'Affiliation': ""Children's Oncology Group Statistics and Data Center, Monrovia, California (Krailo, Buxton).""}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Buxton', 'Affiliation': ""Children's Oncology Group Statistics and Data Center, Monrovia, California (Krailo, Buxton).""}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Lessnick', 'Affiliation': ""Center for Childhood Cancer and Blood Diseases, Abigail Wexner Research Institute, Nationwide Children's Hospital, and The Division of Pediatric Heme/Onc/BMT, The Ohio State University College of Medicine, Columbus (Lessnick).""}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Teot', 'Affiliation': ""the Department of Pathology, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts (Teot).""}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Rakheja', 'Affiliation': 'the Department of Pathology, University of Texas Southwestern Medical Center, Dallas (Rakheja).'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Crompton', 'Affiliation': ""From Dana-Farber/Boston Children's Cancer and Blood Disorders Center, Harvard Medical School, Boston, Massachusetts (DuBois, Crompton, Janeway).""}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Janeway', 'Affiliation': ""From Dana-Farber/Boston Children's Cancer and Blood Disorders Center, Harvard Medical School, Boston, Massachusetts (DuBois, Crompton, Janeway).""}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Gorlick', 'Affiliation': 'the Department of Pediatrics, MD Anderson Cancer Center, Houston, Texas (Gorlick).'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Glade-Bender', 'Affiliation': 'the Department of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, New York (Glade-Bender).'}]",Archives of pathology & laboratory medicine,['10.5858/arpa.2020-0671-OA'] 2634,33768641,Double blind randomized repetitive efficacy test of various occupational skin protection preparations against sodium lauryl sulphate.,"BACKGROUND Skin protection products, formerly named as barrier creams, are being used as primary and secondary prevention measures against occupational dermatoses. Many of these cosmetic products are claimed by manufacturers to be efficacious against wet work-induced skin barrier impairment if applied prior to exposure. However, results of validated and standardized in vivo efficacy tests allowing the comparison of different products are lacking. MATERIAL AND METHODS Efficacy of six skin protection products against sodium lauryl sulphate-induced irritant contact dermatitis was investigated in a double blind, randomized and controlled repetitive irritation study in healthy volunteers using skin physiological methods. Transepidermal water loss (TEWL) results were used to calculate an efficacy index of protection by mathematical/statistical means according to a protocol developed in a German Statutory Accident Insurance (DGUV) multicenter study (research project FP 275). RESULTS All tested products had a demonstrable, protective effect against SLS compared to controls, but their relative efficacy varied significantly. Differences were also seen upon evaluation of other parameters such as corneometry and clinical irritation score (visual score). CONCLUSIONS Product ranking as a result of the established differences allows improved selection of appropriate skin protection products based on objective parameters, as compared to heterogenous product claims.",2021,"All tested products had a demonstrable, protective effect against SLS compared to controls, but their relative efficacy varied significantly.",['healthy volunteers using skin physiological methods'],"['various occupational skin protection preparations against sodium lauryl sulphate', 'six skin protection products against sodium lauryl sulphate-induced irritant contact dermatitis']","['corneometry and clinical irritation score (visual score', 'Transepidermal water loss (TEWL']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0162823', 'cui_str': 'Irritant contact dermatitis'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]",,0.0688718,"All tested products had a demonstrable, protective effect against SLS compared to controls, but their relative efficacy varied significantly.","[{'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Schliemann', 'Affiliation': 'Department of Dermatology, Jena University Medical Center.'}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Müller', 'Affiliation': ""Department of Health Protection, Prevention Division, Employer's Liability Insurance Association for the Food and Hospitality Sector (BGN), Erfurt.""}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Stadeler', 'Affiliation': ""Department of Health Protection, Prevention Division, Employer's Liability Insurance Association for the Food and Hospitality Sector (BGN), Erfurt.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Elsner', 'Affiliation': 'Department of Dermatology, Jena University Medical Center.'}]",Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG,['10.1111/ddg.14359'] 2635,33768581,"Evaluation of a Farm-to-School Intervention to Improve Locally Grown Vegetable Choices of Low-Income, Primary School Students.","BACKGROUND The study objective was to determine impact of a Farm-to-School intervention on low-income, diverse elementary school students' nutrition-related attitudes, self-efficacy, behaviors, and locally grown vegetable choices. METHODS Six elementary schools within 1 US school district were equally assigned to 1 of 3 conditions: Local Message, Nutrition Message, or Control. Locally grown vegetables (kale, green beans, zucchini, butternut squash, and beets) were served twice during lunch over 16 weeks. ""Local"" and ""Nutrition"" groups also received biweekly nutrition education and a messaging campaign in the cafeteria. Knowledge, attitudes, self-efficacy, and related behaviors were assessed using a validated questionnaire. Vegetable selection was assessed using the food service daily production records. General linear model analysis, analysis of covariance, and t tests were performed. RESULTS Students in the ""Local"" group (N = 81) had significantly improved nutrition-related attitudes (p = .0001), preferences (p = .001), and overall vegetable behavior score (p = .002), compared to control (N = 79). There was no difference in overall locally grown vegetable choices, but local beet choices were higher in the ""Local"" (p = .005) and ""Nutrition"" (p = .02) groups compared to control. CONCLUSIONS Messages about local foods in school cafeterias may improve students' attitudes, preferences, and selection of certain locally grown vegetables.",2021,"RESULTS Students in the ""Local"" group (N = 81) had significantly improved nutrition-related attitudes (p = .0001), preferences (p = .001), and overall vegetable behavior score (p = .002), compared to control (N = 79).","['Six elementary schools within 1 US school district', 'Low-Income, Primary School Students']","['Farm-to-School Intervention', 'Locally grown vegetables (kale, green beans, zucchini, butternut squash, and beets) were served twice during lunch over 16\u2009weeks. ', 'Farm-to-School intervention', 'Local Message, Nutrition Message, or Control']","['overall vegetable behavior score', 'local beet choices', 'nutrition-related attitudes', 'Nutrition', 'overall locally grown vegetable choices', 'Knowledge, attitudes, self-efficacy, and related behaviors']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0557759', 'cui_str': 'Farming environment'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0330498', 'cui_str': 'Brassica oleracea'}, {'cui': 'C0598763', 'cui_str': 'Green bean'}, {'cui': 'C0453125', 'cui_str': 'Zucchini'}, {'cui': 'C0330973', 'cui_str': 'Juglans cinerea'}, {'cui': 'C0038076', 'cui_str': 'Squash'}, {'cui': 'C0330391', 'cui_str': 'Beta vulgaris'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0330391', 'cui_str': 'Beta vulgaris'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",81.0,0.0217914,"RESULTS Students in the ""Local"" group (N = 81) had significantly improved nutrition-related attitudes (p = .0001), preferences (p = .001), and overall vegetable behavior score (p = .002), compared to control (N = 79).","[{'ForeName': 'Jesse D', 'Initials': 'JD', 'LastName': 'Chiero', 'Affiliation': 'Graduate Research Assistant, (jesse.chiero@uconn.edu), Nutritional Sciences, University of Connecticut, 27 Manter Road, Unit 4017, Storrs, CT, 06269., USA.'}, {'ForeName': 'Amy R', 'Initials': 'AR', 'LastName': 'Mobley', 'Affiliation': 'Associate Professor, (amy.mobley@ufl.edu), Health Education and Behavior, University of Florida, PO Box 118210, Gainesville, FL, 32611-8210., USA.'}]",The Journal of school health,['10.1111/josh.13019'] 2636,33725432,Efficacy of the ChAdOx1 nCoV-19 Covid-19 Vaccine against the B.1.351 Variant.,"BACKGROUND Assessment of the safety and efficacy of vaccines against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in different populations is essential, as is investigation of the efficacy of the vaccines against emerging SARS-CoV-2 variants of concern, including the B.1.351 (501Y.V2) variant first identified in South Africa. METHODS We conducted a multicenter, double-blind, randomized, controlled trial to assess the safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) in people not infected with the human immunodeficiency virus (HIV) in South Africa. Participants 18 to less than 65 years of age were assigned in a 1:1 ratio to receive two doses of vaccine containing 5×10 10 viral particles or placebo (0.9% sodium chloride solution) 21 to 35 days apart. Serum samples obtained from 25 participants after the second dose were tested by pseudovirus and live-virus neutralization assays against the original D614G virus and the B.1.351 variant. The primary end points were safety and efficacy of the vaccine against laboratory-confirmed symptomatic coronavirus 2019 illness (Covid-19) more than 14 days after the second dose. RESULTS Between June 24 and November 9, 2020, we enrolled 2026 HIV-negative adults (median age, 30 years); 1010 and 1011 participants received at least one dose of placebo or vaccine, respectively. Both the pseudovirus and the live-virus neutralization assays showed greater resistance to the B.1.351 variant in serum samples obtained from vaccine recipients than in samples from placebo recipients. In the primary end-point analysis, mild-to-moderate Covid-19 developed in 23 of 717 placebo recipients (3.2%) and in 19 of 750 vaccine recipients (2.5%), for an efficacy of 21.9% (95% confidence interval [CI], -49.9 to 59.8). Among the 42 participants with Covid-19, 39 cases (92.9%) were caused by the B.1.351 variant; vaccine efficacy against this variant, analyzed as a secondary end point, was 10.4% (95% CI, -76.8 to 54.8). The incidence of serious adverse events was balanced between the vaccine and placebo groups. CONCLUSIONS A two-dose regimen of the ChAdOx1 nCoV-19 vaccine did not show protection against mild-to-moderate Covid-19 due to the B.1.351 variant. (Funded by the Bill and Melinda Gates Foundation and others; ClinicalTrials.gov number, NCT04444674; Pan African Clinical Trials Registry number, PACTR202006922165132).",2021,Both the pseudovirus and the live-virus neutralization assays showed greater resistance to the B.1.351 variant in serum samples obtained from vaccine recipients than in samples from placebo recipients.,"['people not infected with the human immunodeficiency virus (HIV) in South Africa', 'Participants 18 to less than 65 years of age', 'Between June 24 and November 9, 2020, we enrolled 2026 HIV-negative adults (median age, 30 years); 1010 and 1011 participants received at least one dose of']","['ChAdOx1 nCoV-19 Covid-19 Vaccine', 'ChAdOx1 nCoV-19 vaccine (AZD1222', 'placebo or vaccine', 'vaccines', 'ChAdOx1 nCoV-19 vaccine', 'placebo', 'vaccine containing 5×10 10 viral particles or placebo (0.9% sodium chloride solution']","['safety and efficacy of the vaccine against laboratory-confirmed symptomatic coronavirus 2019 illness (Covid-19', 'incidence of serious adverse events', 'mild-to-moderate Covid-19', 'safety and efficacy']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0042760', 'cui_str': 'Virion'}, {'cui': 'C0990166', 'cui_str': 'Sodium Chloride 0.154 MEQ/ML'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]",2026.0,0.840956,Both the pseudovirus and the live-virus neutralization assays showed greater resistance to the B.1.351 variant in serum samples obtained from vaccine recipients than in samples from placebo recipients.,"[{'ForeName': 'Shabir A', 'Initials': 'SA', 'LastName': 'Madhi', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Baillie', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Clare L', 'Initials': 'CL', 'LastName': 'Cutland', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Merryn', 'Initials': 'M', 'LastName': 'Voysey', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Anthonet L', 'Initials': 'AL', 'LastName': 'Koen', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Fairlie', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Sherman D', 'Initials': 'SD', 'LastName': 'Padayachee', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Keertan', 'Initials': 'K', 'LastName': 'Dheda', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Shaun L', 'Initials': 'SL', 'LastName': 'Barnabas', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Qasim E', 'Initials': 'QE', 'LastName': 'Bhorat', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Briner', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Kwatra', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Khatija', 'Initials': 'K', 'LastName': 'Ahmed', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Parvinder', 'Initials': 'P', 'LastName': 'Aley', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Sutika', 'Initials': 'S', 'LastName': 'Bhikha', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Jinal N', 'Initials': 'JN', 'LastName': 'Bhiman', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': ""As'ad E"", 'Initials': 'AE', 'LastName': 'Bhorat', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'du Plessis', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Aliasgar', 'Initials': 'A', 'LastName': 'Esmail', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Groenewald', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Elizea', 'Initials': 'E', 'LastName': 'Horne', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Shi-Hsia', 'Initials': 'SH', 'LastName': 'Hwa', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Aylin', 'Initials': 'A', 'LastName': 'Jose', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Lambe', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Laubscher', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Mookho', 'Initials': 'M', 'LastName': 'Malahleha', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Masebole', 'Initials': 'M', 'LastName': 'Masenya', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Mduduzi', 'Initials': 'M', 'LastName': 'Masilela', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Shakeel', 'Initials': 'S', 'LastName': 'McKenzie', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Kgaogelo', 'Initials': 'K', 'LastName': 'Molapo', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Moultrie', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Suzette', 'Initials': 'S', 'LastName': 'Oelofse', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Faeezah', 'Initials': 'F', 'LastName': 'Patel', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Sureshnee', 'Initials': 'S', 'LastName': 'Pillay', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Rhead', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Hylton', 'Initials': 'H', 'LastName': 'Rodel', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Lindie', 'Initials': 'L', 'LastName': 'Rossouw', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Taoushanis', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Houriiyah', 'Initials': 'H', 'LastName': 'Tegally', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Asha', 'Initials': 'A', 'LastName': 'Thombrayil', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'van Eck', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Constantinos K', 'Initials': 'CK', 'LastName': 'Wibmer', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Durham', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Kelly', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Tonya L', 'Initials': 'TL', 'LastName': 'Villafana', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gilbert', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Pollard', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Tulio', 'Initials': 'T', 'LastName': 'de Oliveira', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Penny L', 'Initials': 'PL', 'LastName': 'Moore', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Sigal', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': 'Alane', 'Initials': 'A', 'LastName': 'Izu', 'Affiliation': 'From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban - all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) - all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2102214'] 2637,33725408,Preformed T cell alloimmunity and HLA eplet mismatch to guide immunosuppression minimization with tacrolimus monotherapy in kidney transplantation: Results of the CELLIMIN trial.,"Personalizing immunosuppression is a major objective in transplantation. Transplant recipients are heterogeneous regarding their immunological memory and primary alloimmune susceptibility. This biomarker-guided trial investigated whether in low immunological-risk kidney transplants without pretransplant DSA and donor-specific T cells assessed by a standardized IFN-γ ELISPOT, low immunosuppression (LI) with tacrolimus monotherapy would be non-inferior regarding 6-month BPAR than tacrolimus-based standard of care (SOC). Due to low recruitment rates, the trial was terminated when 167 patients were enrolled. ELISPOT negatives (E-) were randomized to LI (n = 48) or SOC (n = 53), E+ received the same SOC. Six- and 12-month BPAR rates were higher among LI than SOC/E- (4/35 [13%] vs. 1/43 [2%], p = .15 and 12/48 [25%] vs. 6/53 [11.3%], p = .073, respectively). E+ patients showed similarly high BPAR rates than LI at 6 and 12 months (12/55 [22%] and 13/66 [20%], respectively). These differences were stronger in per-protocol analyses. Post-hoc analysis revealed that poor class-II eplet matching, especially DQ, discriminated E- patients, notably E-/LI, developing BPAR (4/28 [14%] low risk vs. 8/20 [40%] high risk, p = .043). Eplet mismatch also predicted anti-class-I (p = .05) and anti-DQ (p < .001) de novo DSA. Adverse events were similar, but E-/LI developed fewer viral infections, particularly polyoma-virus-associated nephropathy (p = .021). Preformed T cell alloreactivity and HLA eplet mismatch assessment may refine current baseline immune-risk stratification and guide immunosuppression decision-making in kidney transplantation.",2021,Eplet mismatch also predicted anti-class-I (p=0.05) and anti-DQ (p=0.001) de novo DSA.,"['Transplant recipients', '167 patients were enrolled', 'Kidney Transplantation']","['Tacrolimus monotherapy', 'pretransplant DSA and donor-specific T cells assessed by a standardized IFN-γ ELISPOT, low immunosuppression (LI) with tacrolimus monotherapy']","['Six and 12-month BPAR', 'viral infections, particularly Polyoma-virus associated nephropathy', 'BPAR rates', 'Adverse events']","[{'cui': 'C0376387', 'cui_str': 'Recipient, Transplant'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0920508', 'cui_str': 'Enzyme linked immunospot assay'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0032556', 'cui_str': 'Genus Polyomavirus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",167.0,0.145921,Eplet mismatch also predicted anti-class-I (p=0.05) and anti-DQ (p=0.001) de novo DSA.,"[{'ForeName': 'Oriol', 'Initials': 'O', 'LastName': 'Bestard', 'Affiliation': 'Kidney Transplant Unit, Nephrology department, Bellvitge University Hospital, IDIBELL, Barcelona University, Barcelona, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Meneghini', 'Affiliation': 'Kidney Transplant Unit, Nephrology department, Bellvitge University Hospital, IDIBELL, Barcelona University, Barcelona, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Crespo', 'Affiliation': 'Nephrology and Transplantation Laboratory, IDIBELL, Barcelona University, Barcelona, Spain.'}, {'ForeName': 'Frederike', 'Initials': 'F', 'LastName': 'Bemelman', 'Affiliation': 'Renal Transplant Unit, Department of Internal Medicine, Amsterdam University Medical Centers, Academic Medical Center - University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Koch', 'Affiliation': 'Department of Hepatobiliary and Transplant Surgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Hans D', 'Initials': 'HD', 'LastName': 'Volk', 'Affiliation': 'BeCAT, BCRT, and Department of Nephrology & Intensive Care, Charité Universitätsmedizin Berlin, Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Ondrej', 'Initials': 'O', 'LastName': 'Viklicky', 'Affiliation': 'Transplant Laboratory, Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Giral', 'Affiliation': 'Nantes Université, Inserm, CHU Nantes, Centre de Recherche en Transplantation et Immunologie UMR1064, ITUN, Nantes, France.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Banas', 'Affiliation': 'Department of Nephrology, University Medical Center Regensburg, Regensburg, Germany.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Ruiz', 'Affiliation': 'Department of Nephrology, Hospital Universitario ""Marqués de Valdecilla"", Instituto de Investigación ""Marqués de Valdecilla"" (IDIVAL, Santander, Spain.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Melilli', 'Affiliation': 'Kidney Transplant Unit, Nephrology department, Bellvitge University Hospital, IDIBELL, Barcelona University, Barcelona, Spain.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': 'Renal Transplant Unit, Department of Internal Medicine, Amsterdam University Medical Centers, Academic Medical Center - University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'van Duivenvoorden', 'Affiliation': 'Renal Transplant Unit, Department of Internal Medicine, Amsterdam University Medical Centers, Academic Medical Center - University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Nashan', 'Affiliation': 'Department of Hepatobiliary and Transplant Surgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Friedrich', 'Initials': 'F', 'LastName': 'Thaiss', 'Affiliation': 'Department of Hepatobiliary and Transplant Surgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Natalie M', 'Initials': 'NM', 'LastName': 'Otto', 'Affiliation': 'BeCAT, BCRT, and Department of Nephrology & Intensive Care, Charité Universitätsmedizin Berlin, Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Gantuja', 'Initials': 'G', 'LastName': 'Bold', 'Affiliation': 'BeCAT, BCRT, and Department of Nephrology & Intensive Care, Charité Universitätsmedizin Berlin, Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Maik', 'Initials': 'M', 'LastName': 'Stein', 'Affiliation': 'BeCAT, BCRT, and Department of Nephrology & Intensive Care, Charité Universitätsmedizin Berlin, Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Anett', 'Initials': 'A', 'LastName': 'Sefrin', 'Affiliation': 'BeCAT, BCRT, and Department of Nephrology & Intensive Care, Charité Universitätsmedizin Berlin, Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Lachmann', 'Affiliation': 'HLA-Laboratory, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Hruba', 'Affiliation': 'Transplant Laboratory, Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Stranavova', 'Affiliation': 'Transplant Laboratory, Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Brouard', 'Affiliation': 'Nantes Université, Inserm, CHU Nantes, Centre de Recherche en Transplantation et Immunologie UMR1064, ITUN, Nantes, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Braudeau', 'Affiliation': 'Nantes Université, Inserm, CHU Nantes, Centre de Recherche en Transplantation et Immunologie UMR1064, ITUN, Nantes, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Blancho', 'Affiliation': 'Nantes Université, Inserm, CHU Nantes, Centre de Recherche en Transplantation et Immunologie UMR1064, ITUN, Nantes, France.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Banas', 'Affiliation': 'Department of Nephrology, University Medical Center Regensburg, Regensburg, Germany.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Irure', 'Affiliation': 'Immunology Department, University Hospital Marqués de Valdecilla-IDIVAL, Santander, Spain.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Christakoudi', 'Affiliation': ""Institute of Liver Studies, MRC Centre for Transplantation, Department of Inflammation Biology, Faculty of Sciences & Medicine, King's College London, London, UK.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Sanchez-Fueyo', 'Affiliation': ""Institute of Liver Studies, MRC Centre for Transplantation, Department of Inflammation Biology, Faculty of Sciences & Medicine, King's College London, London, UK.""}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Wood', 'Affiliation': 'Transplantation Research and Immunology Group, Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Reinke', 'Affiliation': 'BeCAT, BCRT, and Department of Nephrology & Intensive Care, Charité Universitätsmedizin Berlin, Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Grinyó', 'Affiliation': 'Kidney Transplant Unit, Nephrology department, Bellvitge University Hospital, IDIBELL, Barcelona University, Barcelona, Spain.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.16563'] 2638,33751495,"Relationship Among Treatment, Pruritus, Investigator's Static Global Assessment, and Quality of Life in Patients with Atopic Dermatitis.","INTRODUCTION The Investigator's Static Global Assessment (ISGA) is a 5-point rating scale that is recommended by the US Food and Drug Administration for assessing the severity of atopic dermatitis (AD), and ISGA success is a widely used endpoint in AD clinical studies. In this study, we seek to interpret the relationship of ISGA with treatment, pruritus, and quality of life (QoL) by conducting post hoc analyses of pooled data from two phase 3 crisaborole studies. METHODS Patients aged ≥ 2 years with baseline ISGA of 2 (mild) or 3 (moderate) were randomly assigned 2:1 to receive crisaborole or vehicle for 28 days. Disease severity, pruritus severity, and QoL were assessed with the ISGA, Severity of Pruritus Scale (SPS), and Dermatology Life Quality Index (DLQI; patients aged ≥ 16 years), or Children's Dermatology Life Quality Index (CDLQI; patients aged 2-15 years), respectively. The effect of treatment on ISGA and the relationship between ISGA and QoL were analyzed using a longitudinal repeated-measures model. The interrelationship between treatment, disease severity, pruritus, and QoL was analyzed with a mediation model. RESULTS Overall, 1522 patients (crisaborole, n = 1016; vehicle, n = 506) were included. Estimated longitudinal profiles indicated changes in ISGA by day 8 were large for crisaborole (effect size [ES]: - 0.68) and small for vehicle (ES: - 0.34). There was a direct relationship between ISGA and DLQI and CDLQI severity bands in the longitudinal repeated-measures model. For both QoL mediation models, treatment effects on QoL were mediated indirectly by reduction in pruritus (DLQI, 42.4%; CDLQI, 58.1%) and disease severity (DLQI, 12.2%; CDLQI, 33.1%). CONCLUSIONS These post hoc analyses suggest that ISGA success is a clinically meaningful endpoint associated with reduction in the severity of pruritus and improvement in QoL.",2021,There was a direct relationship between ISGA and DLQI and CDLQI severity bands in the longitudinal repeated-measures model.,"['1522 patients (crisaborole, n\u2009=\u20091016; vehicle, n\u2009=\u2009506) were included', 'Patients aged\u2009≥', 'Patients with Atopic Dermatitis', '2\xa0years with baseline ISGA of 2 (mild) or 3 (moderate', 'patients aged 2-15\xa0years']",['crisaborole or vehicle'],"[""Children's Dermatology Life Quality Index (CDLQI"", 'ISGA', 'ISGA, Severity of Pruritus Scale (SPS), and Dermatology Life Quality Index (DLQI; patients aged\u2009≥', 'severity of pruritus and improvement in QoL', 'disease severity, pruritus, and QoL', 'Disease severity, pruritus severity, and QoL', 'pruritus, and quality of life (QoL', ""Pruritus, Investigator's Static Global Assessment, and Quality of Life"", 'disease severity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4301781', 'cui_str': 'crisaborole'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C4301781', 'cui_str': 'crisaborole'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",1522.0,0.0753495,There was a direct relationship between ISGA and DLQI and CDLQI severity bands in the longitudinal repeated-measures model.,"[{'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Oregon Health and Science University, Portland, OR, USA. simpsone@ohsu.edu.'}, {'ForeName': 'Wynnis L', 'Initials': 'WL', 'LastName': 'Tom', 'Affiliation': ""UC San Diego and Rady Children's Hospital-San Diego, San Diego, CA, USA.""}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Bushmakin', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Cappelleri', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Yosipovitch', 'Affiliation': 'Department of Dermatology, Miami Itch Center, Miller School of Medicine, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Ständer', 'Affiliation': 'Center for Chronic Pruritus, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Luger', 'Affiliation': 'Department of Dermatology, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sanders', 'Affiliation': 'Pfizer Ltd., Surrey, UK.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Gerber', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Daniela E', 'Initials': 'DE', 'LastName': 'Myers', 'Affiliation': 'Pfizer Inc., Collegeville, PA, USA.'}]",Dermatology and therapy,['10.1007/s13555-021-00506-y'] 2639,33751403,Glycaemic Control with Insulin Glargine 300 U/mL in Individuals with Type 2 Diabetes and Chronic Kidney Disease: A REALI European Pooled Data Analysis.,"INTRODUCTION Management of type 2 diabetes mellitus (T2DM) in patients with chronic kidney disease is complex. Using the REALI European pooled database, we determined the impact of baseline renal function on the effectiveness and safety of insulin glargine 300 U/mL (Gla-300) initiated in adults with inadequately controlled T2DM. METHODS Data from 1712 patients with available estimated glomerular filtration rate (eGFR) at baseline were pooled from six 24-week prospective studies. Patients who received once-daily subcutaneous injections of Gla-300 were classified into four renal function subgroups, according to baseline eGFR: ≥ 90 (N = 599), 60-89 (N = 786), 45-59 (N = 219), and 15-44 mL/min/1.73 m 2 (N = 108). RESULTS Compared to those with baseline eGFR ≥ 60 mL/min/1.73 m 2 , patients with lower eGFR values tended to be older, had a longer T2DM duration, and were more likely to present diabetic complications. After 24 weeks of Gla-300 therapy, the least-squares mean (95% confidence interval) decrease in haemoglobin A1c (HbA1c) from baseline (- 1.14% [- 1.28 to - 1.00], - 1.21% [- 1.34 to - 1.08], - 1.19% [- 1.36 to - 1.01], and - 0.99% [- 1.22 to - 0.76]) and the proportion of patients achieving HbA1c < 7.5% (53.3%, 51.3%, 49.5%, and 51.5%) were comparable in the ≥ 90, 60-89, 45-59, and 15-44 mL/min/1.73 m 2 subgroups, respectively. Although the incidence of hypoglycaemia was overall low, more patients in the eGFR 15-44 mL/min/1.73 m 2 subgroup experienced hypoglycaemia at night or at any time of the day compared with higher eGFR subgroups. There were no notable differences between the renal function subgroups in the changes in Gla-300 daily dose and body weight from baseline to week 24. CONCLUSION Although an eGFR of 15-44 mL/min/1.73 m 2 was associated with a slightly increased risk of hypoglycaemia among patients with inadequately controlled T2DM, Gla-300 provided glycaemic improvement with an overall favourable safety profile regardless of baseline eGFR.",2021,"There were no notable differences between the renal function subgroups in the changes in Gla-300 daily dose and body weight from baseline to week 24. CONCLUSION ","['adults with inadequately controlled T2DM', 'Data from 1712 patients with available estimated glomerular filtration rate (eGFR) at baseline were pooled from six 24-week prospective studies', 'patients with chronic kidney disease is complex', 'Individuals with Type\xa02 Diabetes and Chronic Kidney Disease']","['U/mL', 'insulin glargine 300', 'Glycaemic Control with Insulin Glargine 300']","['hypoglycaemia', 'Gla-300 daily dose and body weight', 'risk of hypoglycaemia', 'diabetic complications', 'haemoglobin A1c (HbA1c']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0342257', 'cui_str': 'Diabetic complication'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",1712.0,0.0956625,"There were no notable differences between the renal function subgroups in the changes in Gla-300 daily dose and body weight from baseline to week 24. CONCLUSION ","[{'ForeName': 'Didac', 'Initials': 'D', 'LastName': 'Mauricio', 'Affiliation': 'Department of Endocrinology and Nutrition, CIBERDEM, Hospital de la Santa Creu i Sant Pau Institut de Recerca, Barcelona, Spain. didacmauricio@gmail.com.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Gourdy', 'Affiliation': 'Endocrinology, Diabetology and Nutrition Department, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'Riccardo C', 'Initials': 'RC', 'LastName': 'Bonadonna', 'Affiliation': 'Azienda Ospedaliero-Universitaria di Parma, Parma, Italy.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Freemantle', 'Affiliation': 'Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Bigot', 'Affiliation': 'IVIDATA, Paris, France.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Mauquoi', 'Affiliation': 'IDDI, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Ciocca', 'Affiliation': 'General Medicines, Sanofi, Paris, France.'}, {'ForeName': 'Mireille', 'Initials': 'M', 'LastName': 'Bonnemaire', 'Affiliation': 'General Medicines, Sanofi, Paris, France.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Müller-Wieland', 'Affiliation': 'Department of Medicine I, University Hospital Aachen, Aachen, Germany.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-021-01031-z'] 2640,33751401,"Efficacy and Safety of the Biosimilar IBI301 Plus Standard CHOP (I-CHOP) in Comparison With Rituximab Plus CHOP (R-CHOP) in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL): A Randomized, Double-Blind, Parallel-Group, Phase 3 Trial.","INTRODUCTION Patients with diffuse large B-cell lymphoma (DLBCL) have limited access to rituximab. IBI301 is a recombinant chimeric murine/human anti-CD20 monoclonal antibody and is a candidate biosimilar to rituximab. This study aimed to assess the therapeutic equivalence of IBI301 and rituximab in previously untreated patients with diffuse large B-cell lymphoma (DLBCL). METHODS This multicenter, randomized, double-blind, parallel-group, phase 3 trial compared IBI301 and rituximab, both plus the chemotherapy of doxorubicin, cyclophosphamide, vindesine, and prednisone (CHOP), was conducted in 68 centers across China. Eligible patients with untreated CD20 positive (CD20 + ) DLBCL randomly received IBI301 (375 mg/m 2 ) plus the standard CHOP or rituximab (375 mg/m 2 ) plus the standard CHOP for six cycles of a 21-day cycle. The primary end point was the overall remission rate (ORR). Efficacy equivalence was defined if 95% CIs for the ORR difference between the two groups were within a ± 12.0% margin. RESULTS Between August 22, 2016, and September 5, 2018, 419 patients were randomly allocated into the IBI301 group (N = 209) and rituximab group (N = 210). In the full analysis set, the ORR was 89.9% and 93.8% in the IBI301 and rituximab groups, respectively, and the ORR difference was -3.9% (95% CI - 9.1%-1.3%), falling within a ± 12.0% margin. The occurrences of treatment-emergent adverse events (TEAEs) (100% vs. 99.0%) and AEs of grade ≥ 3 (87.1% vs. 83.3%) were similar in the two groups (P > 0.05). CONCLUSIONS IBI301 had a non-inferiority efficacy and a comparable safety compared with rituximab. IBI301 plus CHOP could be suggested as a candidate treatment regimen for untreated patients with CD20 + DLBCL. TRIAL REGISTRATION This trial is registered on ClinicalTrials.gov (NCT02867566).",2021,"The occurrences of treatment-emergent adverse events (TEAEs) (100% vs. 99.0%) and AEs of grade ≥ 3 (87.1% vs. 83.3%) were similar in the two groups (P > 0.05). ","['Between August 22, 2016, and September 5, 2018, 419 patients', '68 centers across China', 'untreated patients with CD20 + DLBCL', 'Eligible patients with untreated CD20 positive (CD20 + ) DLBCL randomly received', 'Patients with Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL', 'Patients with diffuse large B-cell lymphoma (DLBCL', 'previously untreated patients with diffuse large B-cell lymphoma (DLBCL']","['IBI301 plus CHOP', 'rituximab', 'Biosimilar IBI301 Plus Standard CHOP (I-CHOP', 'IBI301 (375\xa0mg/m 2 ) plus the standard CHOP or rituximab', 'standard CHOP', 'IBI301 and rituximab, both plus the chemotherapy of doxorubicin, cyclophosphamide, vindesine, and prednisone (CHOP', 'Rituximab Plus CHOP (R-CHOP', 'IBI301 and rituximab']","['ORR', 'overall remission rate (ORR', 'Efficacy and Safety', 'Efficacy equivalence', 'ORR difference']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C3888518', 'cui_str': 'CD20 antigen positive'}, {'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0042682', 'cui_str': 'Vindesine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",419.0,0.482524,"The occurrences of treatment-emergent adverse events (TEAEs) (100% vs. 99.0%) and AEs of grade ≥ 3 (87.1% vs. 83.3%) were similar in the two groups (P > 0.05). ","[{'ForeName': 'Yuqin', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Lymphoma and Hematology, Hunan Province Cancer Hospital, Changsha, China.'}, {'ForeName': 'Huilai', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Lymphoma, Tianjin Cancer Hospital, Tianjin, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Experimental Hematology, National Clinical Research Center for Hematological Disorders, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Yuerong', 'Initials': 'Y', 'LastName': 'Shuang', 'Affiliation': 'Cancer Chemotherapy Center, Jiangxi Province Cancer Hospital, Nanchang, China.'}, {'ForeName': 'Keshu', 'Initials': 'K', 'LastName': 'Zhou', 'Affiliation': 'Hematology Department, The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Fangfang', 'Initials': 'F', 'LastName': 'Lv', 'Affiliation': 'Oncology Department, Fudan University Cancer Hospital, Shanghai, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': ""Hematology Department, Yancheng City No. 1 People's Hospital, Yancheng, China.""}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Hematology Department, Tongji Medical College Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Hematology Department, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Huaqing', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Oncology Department, Tianjin City People's Hospital, Tianjin, China.""}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Oncology Department, The Fifth Affiliated Hospital Sun Yat-Sen University, Zhuhai, China.'}, {'ForeName': 'Haiwen', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Qingyuan', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, Affiliated Cancer Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Hematology Department, Jiangsu Province Hospital, Nanjing, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Ge', 'Affiliation': 'Hematology Department, Zhongda Hospital Southeast, Nanjing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Xiang', 'Affiliation': 'Department of Hematology and Oncology, Chongqing Cancer Hospital, Chongqing, China.'}, {'ForeName': 'Shuye', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Hematology Department, First Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Da', 'Initials': 'D', 'LastName': 'Gao', 'Affiliation': 'Hematology Department, Affiliated Hospital of Inner Mongolia Medical University, Hohhot, China.'}, {'ForeName': ""Shun'e"", 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Lymphoma and Breast Cancer, First Affiliated Hospital of Xinjiang Medical University, Urumchi, China.'}, {'ForeName': 'Jinying', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': ""Department of Hematological Rheumatology, People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Oncology Department, Hainan General Hospital, Haikou, China.'}, {'ForeName': 'Liqun', 'Initials': 'L', 'LastName': 'Zou', 'Affiliation': 'Department of Oncology, West China Hospital Sichuan University, Chengdu, China.'}, {'ForeName': 'Meifang', 'Initials': 'M', 'LastName': 'Zheng', 'Affiliation': 'Department of Hematology, Linyi Cancer Hospital, Linyi, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Hematology Department, Third Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Zonghong', 'Initials': 'Z', 'LastName': 'Shao', 'Affiliation': 'Hematology Department, General Hospital, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Pang', 'Affiliation': 'Hematology Department, Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Ruixiang', 'Initials': 'R', 'LastName': 'Xia', 'Affiliation': 'Hematology Department, First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Oncology Department, Second Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Hou', 'Affiliation': 'Hematology Department, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Hongxia', 'Initials': 'H', 'LastName': 'Yao', 'Affiliation': 'Hematology Department, Hainan General Hospital, Haikou, China.'}, {'ForeName': 'Ru', 'Initials': 'R', 'LastName': 'Feng', 'Affiliation': 'Hematology Department, Nanfang Hospital, Guangzhou, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Cai', 'Affiliation': 'Department of Hematology, First Affiliated Hospital of Zhejiang Medical University, Hangzhou, China.'}, {'ForeName': 'Mingzhi', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Oncology Department, First Affiliated Hospital of Zhengzhou Medical University, Zhengzhou, China.'}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Ran', 'Affiliation': 'Cancer Center, Chongqing Three-Gorge Central Hospital, Chongqing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Hematology Department, First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Zeng', 'Affiliation': 'Oncology Department, Xiangya Hospital Central South University, Changsha, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Hematology Department, Shengjing Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Hematology Department, Affiliated Zhongshan Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Aibin', 'Initials': 'A', 'LastName': 'Liang', 'Affiliation': 'Hematology Department, Tongji Hospital of Tongji University, Shanghai, China.'}, {'ForeName': 'Xuelan', 'Initials': 'X', 'LastName': 'Zuo', 'Affiliation': 'Hematology Department, Zhongnan Hospital of Wuhan, Wuhan, China.'}, {'ForeName': 'Qingfeng', 'Initials': 'Q', 'LastName': 'Zou', 'Affiliation': 'Department of Oncology, Affiliated Cancer Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Junxun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Oncology, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sang', 'Affiliation': 'Department of Hematology, Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Oncology Department, Shanghai East Hospital, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Hematology Department, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Yongqing', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Department of Hematology and Oncology, First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Hematology Department, First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Jifeng', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Oncology Department, Jiangsu Cancer Hospital, Nanjing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': ""Hematology Department, Second People's Hospital of Shenzhen, Shenzhen, China.""}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Hematology Department, Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Hongguo', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Hematology Department, Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Innovent Biologics, Inc, Suzhou, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Innovent Biologics, Inc, Suzhou, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Innovent Biologics, Inc, Suzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital and Institute, Beijing, China. zhu-jun2017@outlook.com.'}, {'ForeName': 'Lugui', 'Initials': 'L', 'LastName': 'Qiu', 'Affiliation': 'State Key Laboratory of Experimental Hematology, National Clinical Research Center for Hematological Disorders, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China. qiulg@ihcams.ac.cn.'}]",Advances in therapy,['10.1007/s12325-020-01603-8'] 2641,33760092,Family-Centered Prevention Effects on the Association Between Racial Discrimination and Mental Health in Black Adolescents: Secondary Analysis of 2 Randomized Clinical Trials.,"Importance Some Black adolescents who frequently experience racial discrimination develop mental health problems. Protective caregiving may buffer adolescents from the negative mental health outcomes associated with experiencing racial discrimination. Objective To examine if participation in programs that enhance protective caregiving will attenuate the positive association between Black adolescents' encounters with discrimination and subsequent increases in mental health problems. Design, Setting, and Participants This secondary analysis used data from 2 randomized clinical trials testing family-centered prevention programs: the Strong African American Families-Teen (SAAF-T) program and the Adults in the Making (AIM) program. The programs were implemented in community locations convenient for participants in 12 rural Georgia counties. For the SAAF-T trial, Black adolescents and their primary caregivers were recruited from 2007 to 2008. In the AIM trial Black adolescents and their primary caregivers were recruited from 2006 to 2007. Data for this study were analyzed from June to August 2020. Exposures Adolescents provided data at baseline on the frequency of their encounters with racial discrimination. Treatment group participants in each trial took part in a family-centered prevention program designed to prevent substance use and mental health problems. SAAF-T is a 5-session, 10-hour psychosocial intervention for families with a Black adolescent aged 14 to 16 years. AIM is a 6-session, 12-hour psychosocial intervention for families with a Black youth who is a high school senior. Main Outcomes and Measures The primary outcomes were mental health problems, including conduct problems and depression or anxiety symptoms. Results The SAAF-T study included 502 Black adolescents (mean [SD] age, 16.0 [0.6] years; 281 [56.0%] girls), including 252 randomized to the intervention and 250 randomized to the control, and the AIM trial included 367 Black adolescents (mean [SD] age, 17.7 [0.8] years; 217 [59.1%] girls and women), including 187 randomized to the intervention and 180 randomized to the control. Adolescents assigned to the SAAF-T intervention group who frequently experienced discrimination at baseline evinced fewer subsequent increases in conduct problems (incident risk ratio, 0.530 [95% CI, 0.340 to 0.783]). Adolescents assigned to the AIM intervention group who frequently experienced discrimination at baseline evinced fewer subsequent increases in conduct problems (mean difference, -0.361 [95% CI, -0.577 to -0.144]) and fewer subsequent increases in depression or anxiety symptoms (mean difference, -0.220 [95% CI -0.402 to -0.038]). Moderated mediation analyses suggested that enhanced protective caregiving was partially responsible for all observed interaction effects (indirect effect: SAAF-T conduct problems, -0.063 [95% CI, -0.127 to -0.001]; AIM conduct problems, -0.048 [95% CI, -0.095 to -0.001]; AIM depression or anxious symptoms, -0.036 [95% CI, -0.074 to 0]). Conclusions and Relevance This secondary analysis of 2 randomized clinical trials found that participation in family-centered preventive interventions attenuated the association between frequent exposure to discriminatory behaviors and subsequent mental health problems. Notably, all but 1 of the treatment and moderated-mediation findings were reproduced across the SAAF-T and AIM trials. Trial Registrations ClinicalTrials.gov Identifiers: SAAF-T, NCT04501471; AIM, NCT04510116.",2021,"Adolescents assigned to the SAAF-T intervention group who frequently experienced discrimination at baseline evinced fewer subsequent increases in conduct problems (incident risk ratio, 0.530 [95% CI, 0.340 to 0.783]).","['African American Families-Teen (SAAF-T) program and the Adults in the Making (AIM) program', 'Black adolescents who frequently experience racial discrimination develop mental health problems', 'Black adolescents and their primary caregivers were recruited from 2006 to 2007', 'families with a Black adolescent aged 14 to 16 years', '502 Black adolescents (mean [SD] age, 16.0 [0.6] years; 281 [56.0%] girls', 'Black Adolescents', 'Black adolescents and their primary caregivers were recruited from 2007 to 2008', '367 Black adolescents (mean [SD] age, 17.7 [0.8] years; 217 [59.1%] girls and women), including 187 randomized to the intervention and 180 randomized to the control', '12 rural Georgia counties', 'families with a Black youth who is a high school senior']","['family-centered prevention program designed to prevent substance use and mental health problems', 'SAAF-T intervention', 'SAAF-T']","['conduct problems', 'mental health problems, including conduct problems and depression or anxiety symptoms', 'depression or anxiety symptoms', 'depression or anxious symptoms']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205905', 'cui_str': 'Racial Discrimination'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C1319883', 'cui_str': 'Primary caregiver'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517598', 'cui_str': '17.7'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0017452', 'cui_str': 'Georgia state'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",367.0,0.348992,"Adolescents assigned to the SAAF-T intervention group who frequently experienced discrimination at baseline evinced fewer subsequent increases in conduct problems (incident risk ratio, 0.530 [95% CI, 0.340 to 0.783]).","[{'ForeName': 'Gene H', 'Initials': 'GH', 'LastName': 'Brody', 'Affiliation': 'Center for Family Research, University of Georgia, Athens.'}, {'ForeName': 'Tianyi', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': 'Center for Family Research, University of Georgia, Athens.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Chen', 'Affiliation': 'Department of Psychology and Institute for Public Policy, Northwestern University, Evanston, Illinois.'}, {'ForeName': 'Gregory E', 'Initials': 'GE', 'LastName': 'Miller', 'Affiliation': 'Department of Psychology and Institute for Public Policy, Northwestern University, Evanston, Illinois.'}, {'ForeName': 'Allen W', 'Initials': 'AW', 'LastName': 'Barton', 'Affiliation': 'Department of Human Development and Family Studies, University of Illinois, Champagne-Urbana.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Kogan', 'Affiliation': 'Department of Human Development and Family Science and Center for Family Research, University of Georgia, Athens.'}]",JAMA network open,['10.1001/jamanetworkopen.2021.1964'] 2642,33756064,Comparative evaluation of fluorinol and calcium sodium phosphosilicate-containing toothpastes in the treatment of dentin hypersensitivity.,"BACKGROUND Dentin hypersensitivity is one of the most commonly encountered clinical problems. Various desensitizing agents have been widely used in the management of dentin hypersensitivity. Fluorinol, a fluoride-containing agent, has shown to be effective in fluoridating the hydroxyapatite crystal and thus reduce enamel solubility. Calcium sodium phosphosilicate mechanically occludes open tubules and releases calcium and phosphorous to remineralize tooth structure. OBJECTIVE To compare and assess the efficacy of fluorinol-containing toothpaste with 7.5% sodium calcium phosphosilicate-containing toothpaste in reducing dentin hypersensitivity. METHODOLOGY Thorough oral prophylaxis was done, and the patients were subjected to the washout phase, after which they were randomly allocated to the two study groups, Group A-fluorinol-containing toothpaste, Group B-sodium calcium phosphosilicate-containing toothpaste. Patients were recalled on 2 nd , 3 rd and 4 th weeks, and sensitivity was assessed using VAS scores by means of tactile, evaporative and cold water stimuli. Oral health-related quality of life was assessed using OHIP-14 questionnaire at baseline and 4 weeks. RESULT Compared to baseline, there was a significant decrease in dentin hypersensitivity in both the groups. The VAS scores for tactile stimuli were significantly lower in group A at 3 rd and 4 th weeks. CONCLUSION Fluorinol-containing toothpaste was shown to be effective in reducing dentinal hypersensitivity. Hence, it can be used routinely in the management of dentin hypersensitivity.",2021,"The VAS scores for tactile stimuli were significantly lower in group A at 3 rd and 4 th weeks. ",[],"['Fluorinol containing toothpaste', 'Fluorinol containing toothpaste with 7.5% sodium calcium phosphosilicate containing toothpaste', 'Fluorinol containing toothpaste, Group B - sodium calcium phosphosilicate containing toothpaste', 'Fluorinol and Calcium Sodium Phosphosilicate containing Toothpastes', 'Calcium Sodium Phosphosilicate']","['dentin hypersensitivity', 'dentinal hypersensitivity', 'Oral-health related quality of life', 'VAS scores for tactile stimuli', 'VAS scores by means of tactile, evaporative and cold water stimuli', 'Dentin Hypersensitivity']",[],"[{'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4708833', 'cui_str': 'Cold water'}]",,0.0131949,"The VAS scores for tactile stimuli were significantly lower in group A at 3 rd and 4 th weeks. ","[{'ForeName': 'Eeshita', 'Initials': 'E', 'LastName': 'Bhowmik', 'Affiliation': 'Department of Periodontology, JSS Dental College & Hospital, JSS Academy of Higher Education & Research, Mysuru, India.'}, {'ForeName': 'Deepika', 'Initials': 'D', 'LastName': 'Pawar Chandrashekhar', 'Affiliation': 'Department of Periodontology, JSS Dental College & Hospital, JSS Academy of Higher Education & Research, Mysuru, India.'}, {'ForeName': 'Manohar', 'Initials': 'M', 'LastName': 'Sharma Hareesha', 'Affiliation': 'Department of Periodontology, JSS Dental College & Hospital, JSS Academy of Higher Education & Research, Mysuru, India.'}]",International journal of dental hygiene,['10.1111/idh.12495'] 2643,33761920,"Effects of a randomized controlled trial of a brief, student-nurse led, parent-based sexual health intervention on parental protective factors and HPV vaccination uptake.","BACKGROUND Parents play a pivotal role in adolescent sexual health and Human Papillomavirus (HPV) vaccination. Nurses are on the frontlines of healthcare and play a critical role in promoting HPV vaccination and parent-child sexual health communication. We enhanced the Families Talking Together (FTT) parent-based sexual health curriculum to include adolescent vaccinations herein, FTT + HPV, and trained student nurses to provide a strong HPV vaccination and parent-child sexual health communication endorsement. METHODS Using a randomized attention-controlled trial design, we examined the efficacy of FTT + HPV among 519 parents and their 11-14 year old youth recruited from medically underserved communities between 2015 and 2018. Participants were recruited from 22 after-school programs (e.g., Boys and Girls Clubs) and 19 charter schools. For parents, we examined protective factors including parent-child sexual health communication and parental involvement. For youth, we examined sexual health knowledge, parent-child sexual health communication, and parent-child connectedness. To assess HPV vaccination initiation and completion, we searched IMMTRAC immunization registry records for 85% of youth and used parental report for youth without registry records. Group differences were calculated using the estimated mean difference at one- and six months post-intervention with significance set at the p < 0.05 level. RESULTS Baseline rates of HPV vaccination were low at 55.7%. No significant difference between the groups was seen in vaccination initiation or completion rates by one-month post-intervention. However, by six-months post intervention, there was a significant difference between the groups with 70.3% of the intervention group initiating the HPV vaccination series vs. 60.6% for the control group (p = 0.02). No difference between the groups was found for HPV series completion at six-months. There were significant differences in condom knowledge (p = 0.04), parent-child connectedness (p = 0.04), and communication frequency (p = 0.001) with greater improvement in the intervention vs. the control group. Rates of sexual activity remained low in both groups throughout the six-month follow-up period. CONCLUSION A brief parent-based adolescent sexual health and HPV vaccination intervention delivered by student nurses can improve sexual health outcomes including protective parental factors, adolescent sexual health knowledge, and HPV vaccination initiation rates. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02600884 . Prospectively registered September 1, 2015.",2021,"There were significant differences in condom knowledge (p = 0.04), parent-child connectedness (p = 0.04), and communication frequency (p = 0.001) with greater improvement in the intervention vs. the control group.","['519 parents and their 11-14\u2009year old youth recruited from medically underserved communities between 2015 and 2018', '85% of youth and used parental report for youth without registry records', 'Participants were recruited from 22 after-school programs (e.g., Boys and Girls Clubs) and 19 charter schools']","['HPV vaccination intervention', 'FTT\u2009+\u2009HPV', 'student-nurse led, parent-based sexual health intervention']","['vaccination initiation or completion rates', 'condom knowledge', 'communication frequency', 'sexual health outcomes including protective parental factors, adolescent sexual health knowledge, and HPV vaccination initiation rates', 'HPV series completion', 'Rates of sexual activity', 'HPV vaccination', 'parent-child connectedness']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}]","[{'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",,0.0576692,"There were significant differences in condom knowledge (p = 0.04), parent-child connectedness (p = 0.04), and communication frequency (p = 0.001) with greater improvement in the intervention vs. the control group.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Santa Maria', 'Affiliation': 'University of Texas Health Science Center at Houston, Cizik School of Nursing, 6901 Bertner Ave, Houston, TX, USA. diane.m.santamaria@uth.tmc.edu.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Markham', 'Affiliation': 'Health Promotion and Behavioral Sciences, University of Texas Health Science Center at Houston School of Public Health, 7000 Fannin Street, Houston, TX, USA.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Misra', 'Affiliation': ""Baylor College of Medicine, Texas Children's Hospital, 8080 North Stadium Drive, Suite 250, Houston, TX, USA.""}, {'ForeName': 'D C', 'Initials': 'DC', 'LastName': 'Coleman', 'Affiliation': 'University of Texas Health Science Center at Houston, Cizik School of Nursing, 6901 Bertner Ave, Houston, TX, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lyons', 'Affiliation': 'University of Texas Health Science Center at Houston, Cizik School of Nursing, 6901 Bertner Ave, Houston, TX, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Desormeaux', 'Affiliation': 'Cizik School of Nursing, University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cron', 'Affiliation': 'Cizik School of Nursing, University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Guilamo-Ramos', 'Affiliation': 'Center for Latino Adolescent and Family Health, New York University, New York, NY, USA.'}]",BMC public health,['10.1186/s12889-021-10534-0'] 2644,33764445,Randomized trial of granulocyte colony-stimulating factor for spinal cord injury.,"Attenuation of the secondary injury of spinal cord injury (SCI) can suppress the spread of spinal cord tissue damage, possibly resulting in spinal cord sparing that can improve functional prognoses. Granulocyte colony-stimulating factor (G-CSF) is a haematological cytokine commonly used to treat neutropenia. Previous reports have shown that G-CSF promotes functional recovery in rodent models of SCI. Based on preclinical results, we conducted early phase clinical trials, showing safety/feasibility and suggestive efficacy. These lines of evidence demonstrate that G-CSF might have therapeutic benefits for acute SCI in humans. To confirm this efficacy and to obtain strong evidence for pharmaceutical approval of G-CSF therapy for SCI, we conducted a phase 3 clinical trial designed as a prospective, randomized, double-blinded and placebo-controlled comparative trial. The current trial included cervical SCI [severity of American Spinal Injury Association (ASIA) Impairment Scale (AIS) B or C] within 48 h after injury. Patients are randomly assigned to G-CSF and placebo groups. The G-CSF group was administered 400 μg/m2/day × 5 days of G-CSF in normal saline via intravenous infusion for five consecutive days. The placebo group was similarly administered a placebo. Allocation was concealed between blinded evaluators of efficacy/safety and those for laboratory data, as G-CSF markedly increases white blood cell counts that can reveal patient treatment. Efficacy and safety were evaluated by blinded observer. Our primary end point was changes in ASIA motor scores from baseline to 3 months after drug administration. Each group includes 44 patients (88 total patients). Our protocol was approved by the Pharmaceuticals and Medical Device Agency in Japan and this trial is funded by the Center for Clinical Trials, Japan Medical Association. There was no significant difference in the primary end point between the G-CSF and the placebo control groups. In contrast, one of the secondary end points showed that the ASIA motor score 6 months (P = 0.062) and 1 year (P = 0.073) after drug administration tend to be higher in the G-CSF group compared with the placebo control group. Moreover, in patients aged over 65 years old, motor recovery 6 months after drug administration showed a strong trend towards a better recovery in the G-CSF treated group (P = 0.056) compared with the control group. The present trial failed to show a significant effect of G-CSF in primary end point although the subanalyses of the present trial suggested potential G-CSF benefits for specific population.",2021,There was no significant difference in the primary end point between the G-CSF and the placebo control groups.,"['spinal cord injury', '44 patients (88 total patients']","['granulocyte colony-stimulating factor', 'G-CSF and placebo', 'placebo', 'Granulocyte colony-stimulating factor (G-CSF', 'G-CSF']","['cervical SCI [severity of American Spinal Injury Association (ASIA', 'Impairment Scale (AIS) B or C', 'ASIA motor scores', 'efficacy/safety', 'Efficacy and safety', 'ASIA motor score']","[{'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0840414', 'cui_str': 'Cervical spinal cord injury'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0037937', 'cui_str': 'Spinal injury'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.462054,There was no significant difference in the primary end point between the G-CSF and the placebo control groups.,"[{'ForeName': 'Masao', 'Initials': 'M', 'LastName': 'Koda', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Hanaoka', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Yasuhisa', 'Initials': 'Y', 'LastName': 'Fujii', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Hanawa', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Kawasaki', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Yoshihito', 'Initials': 'Y', 'LastName': 'Ozawa', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Tadami', 'Initials': 'T', 'LastName': 'Fujiwara', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Takeo', 'Initials': 'T', 'LastName': 'Furuya', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Ijima', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Saito', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Kitamura', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Miyamoto', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Ohtori', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Yukei', 'Initials': 'Y', 'LastName': 'Matsumoto', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Abe', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Takahashi', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Hirano', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Ohashi', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Shoji', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Tatsuki', 'Initials': 'T', 'LastName': 'Mizouchi', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Kawahara', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Kawaguchi', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Yugo', 'Initials': 'Y', 'LastName': 'Orita', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Sasamoto', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Yoshioka', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Fujii', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Katsutaka', 'Initials': 'K', 'LastName': 'Yonezawa', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Soma', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Taneichi', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Daisaku', 'Initials': 'D', 'LastName': 'Takeuchi', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Inami', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Moridaira', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Haruki', 'Initials': 'H', 'LastName': 'Ueda', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Futoshi', 'Initials': 'F', 'LastName': 'Asano', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Shibao', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Ikuo', 'Initials': 'I', 'LastName': 'Aita', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Takeuchi', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Mimura', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Shimbo', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Someya', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Sumio', 'Initials': 'S', 'LastName': 'Ikenoue', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Sameda', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Kan', 'Initials': 'K', 'LastName': 'Takase', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Ikeda', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Fumitake', 'Initials': 'F', 'LastName': 'Nakajima', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Hashimoto', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Fumio', 'Initials': 'F', 'LastName': 'Hasue', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Fujiyoshi', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Koshiro', 'Initials': 'K', 'LastName': 'Kamiya', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Katoh', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Matsuyama', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Tomohiko', 'Initials': 'T', 'LastName': 'Hasegawa', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Go', 'Initials': 'G', 'LastName': 'Yoshida', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Arima', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Yamato', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Oe', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Togawa', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Sho', 'Initials': 'S', 'LastName': 'Kobayashi', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Akeda', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Kawamoto', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Imai', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Sakakibara', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Sudo', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Ito', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kikuchi', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Takigawa', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Morita', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Tanaka', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Kazuyoshi', 'Initials': 'K', 'LastName': 'Nakanishi', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Naosuke', 'Initials': 'N', 'LastName': 'Kamei', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Kotaka', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Baba', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Okudaira', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Konishi', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Keigo', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Yoshito', 'Initials': 'Y', 'LastName': 'Katayama', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Matsumoto', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Matsumoto', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Haruo', 'Initials': 'H', 'LastName': 'Kanno', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Toshimi', 'Initials': 'T', 'LastName': 'Aizawa', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Ko', 'Initials': 'K', 'LastName': 'Hashimoto', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Toshimitsu', 'Initials': 'T', 'LastName': 'Eto', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Takehiro', 'Initials': 'T', 'LastName': 'Sugaya', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Michiharu', 'Initials': 'M', 'LastName': 'Matsuda', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Kazunari', 'Initials': 'K', 'LastName': 'Fushimi', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Nozawa', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Chizuo', 'Initials': 'C', 'LastName': 'Iwai', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Taguchi', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Tsukasa', 'Initials': 'T', 'LastName': 'Kanchiku', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Nishida', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Funaba', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Sakai', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Imajo', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Yamazaki', 'Affiliation': 'G-SPIRIT Study Group, Chiba, Japan.'}]",Brain : a journal of neurology,['10.1093/brain/awaa466'] 2645,33770629,Induction of labor using balloon catheter as an outpatient versus prostaglandin as an inpatient: A cost-effectiveness analysis.,"OBJECTIVE The aim of this work was to assess the cost-effectiveness of induction of labor with outpatient balloon catheter cervical priming versus inpatient prostaglandin vaginal gel or tape. STUDY DESIGN Economic evaluation alongside a multi-centre, randomized controlled trial at eight Australian maternity hospitals. The trial reported on 448 women with live singleton term pregnancies, undergoing induction of labor for low-risk indications between September 2015 and October 2018. An economic decision tree model was designed from a health services perspective from time of induction of labor to hospital discharge. Sensitivity and subgroup analyses were performed to test the robustness of model outcomes. We estimated resource use, collected data on health outcomes (using EQ-5D-3 L questionnaire) and reported cost (Australian Dollars) per quality-adjusted life year gained, incremental cost-effect ratio and net monetary benefit. RESULTS Deterministic analysis showed lower mean costs ($7294 versus $7585) in the outpatient-balloon (n = 205) compared to the inpatient-prostaglandin group (n = 243), with similar health outcomes (0.75 vs 0.74 quality-adjusted life years gained) and overall higher net monetary benefit ($30,054 vs $29,338). In probabilistic analyses outpatient-balloon induction of labor was cost-effective in 55.3 % of all simulations and 59.1 % for women with favourable cervix (modified Bishop score >3) and 64.5 % for nulliparous women. CONCLUSIONS Outpatient-balloon induction of labor may be cost-saving compared to inpatient induction of labor with prostaglandin and is most likely to be cost-effective for nulliparous women, but more research is warranted in other settings to explore the generalisability of results.",2021,"In probabilistic analyses outpatient-balloon induction of labor was cost-effective in 55.3 % of all simulations and 59.1 % for women with favourable cervix (modified Bishop score >3) and 64.5 % for nulliparous women. ","['448 women with live singleton term pregnancies, undergoing induction of labor for low-risk indications between September 2015 and October 2018', 'eight Australian maternity hospitals', 'nulliparous women']",['labor with outpatient balloon catheter cervical priming versus inpatient prostaglandin vaginal gel or tape'],"['mean costs', 'health outcomes (using EQ-5D-3 L questionnaire) and reported cost (Australian Dollars) per quality-adjusted life year gained, incremental cost-effect ratio and net monetary benefit']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0232991', 'cui_str': 'Term pregnancy'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0020010', 'cui_str': 'Maternity Hospitals'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}]","[{'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0441127', 'cui_str': 'Balloon dilatation catheter'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C0042257', 'cui_str': 'Vaginal gel'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0562019', 'cui_str': 'dollar'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}]",448.0,0.128009,"In probabilistic analyses outpatient-balloon induction of labor was cost-effective in 55.3 % of all simulations and 59.1 % for women with favourable cervix (modified Bishop score >3) and 64.5 % for nulliparous women. ","[{'ForeName': 'Katharina M D', 'Initials': 'KMD', 'LastName': 'Merollini', 'Affiliation': 'School of Health and Behavioural Sciences, University of the Sunshine Coast, Queensland, Australia; Sunshine Coast Health Institute, Sunshine Coast University Hospital, Queensland, Australia. Electronic address: kmerolli@usc.edu.au.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Beckmann', 'Affiliation': 'Mater Research, The University of Queensland, Queensland, Australia; University of Queensland, School of Medicine, Queensland, Australia; Mater Mothers Hospitals, Queensland, Australia.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2021.03.020'] 2646,33770556,Homework adherence predicts therapeutic improvement from behavior therapy in Tourette's disorder.,"Behavior therapy is a first-line intervention for Tourette's Disorder (TD), and a key component is the practice of therapeutic skills between treatment visits (i.e., homework). This study examined the relationship between homework adherence during behavior therapy for TD and therapeutic outcomes, and explored baseline predictors of homework adherence during treatment. Participants included 119 individuals with TD (70 youth, 49 adults) who received behavior therapy in a clinical trial. After a baseline assessment of tic severity and clinical characteristics, participants received 8 sessions of behavior therapy. Therapists recorded homework adherence at each therapy session. After treatment, tic severity was re-assessed by independent evaluators masked to treatment condition. Greater overall homework adherence predicted tic severity reductions and treatment response across participants. Early homework adherence predicted therapeutic improvement in youth, whereas late adherence predicted improvement in adults. Baseline predictors of greater homework adherence in youth included lower hyperactivity/impulsivity and caregiver strain. Meanwhile in adults, baseline predictors of increased homework adherence included younger age, lower hyperactivity/impulsivity, obsessive-compulsive severity, anger, and greater work-related disability. Homework adherence is an integral component of behavior therapy and linked to therapeutic improvement. Strategies that improve homework adherence may optimize the efficacy of behavioral treatments and improve treatment outcomes.",2021,Greater overall homework adherence predicted tic severity reductions and treatment response across participants.,"[""Tourette's disorder"", 'Participants included 119 individuals with TD (70 youth, 49 adults) who received']","['Behavior therapy', 'behavior therapy']","['hyperactivity/impulsivity, obsessive-compulsive severity, anger, and greater work-related disability', 'hyperactivity/impulsivity and caregiver strain', 'homework adherence']","[{'cui': 'C0040517', 'cui_str': ""Gilles de la Tourette's syndrome""}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0589414', 'cui_str': 'Homework'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",119.0,0.0199729,Greater overall homework adherence predicted tic severity reductions and treatment response across participants.,"[{'ForeName': 'Joey K-Y', 'Initials': 'JK', 'LastName': 'Essoe', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Department of Psychiatry & Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Ricketts', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Kesley A', 'Initials': 'KA', 'LastName': 'Ramsey', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Department of Psychiatry & Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Piacentini', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Douglas W', 'Initials': 'DW', 'LastName': 'Woods', 'Affiliation': 'Department of Psychology, Marquette University, Milwaukee, WI, USA.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, Texas, USA; Department of Psychology, University of Texas at San Antonio, San Antonio, TX, USA; South Texas Veterans Health Care System, San Antonio, TX, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Scahill', 'Affiliation': 'Marcus Autism Center, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Wilhelm', 'Affiliation': 'Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Walkup', 'Affiliation': ""Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, IL, USA.""}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'McGuire', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Department of Psychiatry & Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: jfmcguire@jhmi.edu.'}]",Behaviour research and therapy,['10.1016/j.brat.2021.103844'] 2647,33771774,Differential effects of epidermal growth factor receptor inhibitors in a single patient with neuropathic pain.,"Neuropathic pain (NP) represents an unmet medical need, where analgesic responses to different epidermal growth factor receptor inhibitors (EGFR-Is) have been described. The human EGFR family of receptors consists of four members (human epidermal growth factor receptor, HER 1-4), signalling via different homodimer and heterodimer combinations. A 52-year-old man was treated with the EGFR-I cetuximab in a trial of severe NP. Pain scores decreased dramatically after blinded cetuximab, but not after placebo. On pain recurrence after the trial, he was prescribed the oral EGFR-Is erlotinib, gefitinib, and lapatinib without relief. However, treatment with the pan-HER-inhibitor afatinib was effective. After 4 years on afatinib, pain control remains excellent with manageable side effects. This is the first reported observation of differential effects of EGFR-Is on NP in the same patient and the first report describing NP relief with afatinib. Further understanding of the underlying pathophysiology could lead to development of EGFR-Is specifically targeting NP.",2021,"Pain scores decreased dramatically after blinded cetuximab, but not after placebo.",['single patient with neuropathic pain'],"['epidermal growth factor receptor inhibitors', 'placebo', 'EGFR-I cetuximab']","['pain recurrence', 'Pain scores', 'Neuropathic pain (NP']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}]","[{'cui': 'C1443775', 'cui_str': 'Epidermal growth factor receptor antagonist-containing product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}]",,0.0805028,"Pain scores decreased dramatically after blinded cetuximab, but not after placebo.","[{'ForeName': 'Marte Grønlie', 'Initials': 'MG', 'LastName': 'Cameron', 'Affiliation': 'Center for Cancer Treatment, Southern Norway Hospital Trust, Kristiansand, Norway Marte.Gronlie.Cameron@sshf.no.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kersten', 'Affiliation': 'Center for Cancer Treatment, Southern Norway Hospital Trust, Kristiansand, Norway.'}]",BMJ case reports,['10.1136/bcr-2020-239385'] 2648,33771763,Lack of effect of Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb12 on beta-cell function in children with newly diagnosed type 1 diabetes: a randomised controlled trial.,"INTRODUCTION The gut microbiota may be relevant in the development of type 1 diabetes (T1D). We examined the effects of Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb12 on beta-cell function in children with newly diagnosed T1D. RESEARCH DESIGN AND METHODS Children aged 8-17 years with newly (within 60 days) diagnosed T1D were enrolled in a double-blind, randomised controlled trial in which they received L. rhamnosus GG and B. lactis Bb12 at a dose of 10 9 colony-forming units or placebo, orally, once daily, for 6 months. The follow-up was for 12 months. The primary outcome measure was the area under the curve (AUC) of the C-peptide level during 2-hour responses to a mixed meal. RESULTS Ninety-six children were randomised (probiotics, n=48; placebo n=48; median age 12.3 years). Eighty-eight (92%) completed the 6-month intervention, and 87 (91%) completed the follow-up at 12 months. There was no significant difference between the study groups for the AUC of the C-peptide level. For the secondary outcomes at 6 months, there were no differences between the study groups. At 12 months, with one exception, there also were no significant differences between the groups. Compared with the placebo group, there was a significantly increased number of subjects with thyroid autoimmunity in the probiotic group. However, at baseline, there was also a higher frequency of thyroid autoimmunity in the probiotic group. There were no cases of severe hypoglycemia or ketoacidosis in any of the groups. No adverse events related to the study products were reported. CONCLUSIONS L. rhamnosus GG and B. lactis Bb12, as administered in this study, had no significant effect in maintaining the residual pancreatic beta-cell function in children with newly diagnosed T1D. It remains unclear which probiotics, if any, alone or in combination, are potentially the most useful for management of T1D. TRIAL REGISTRATION NUMBER NCT03032354.",2021,There was no significant difference between the study groups for the AUC of the C-peptide level.,"['children with newly diagnosed type 1 diabetes', 'Children aged 8-17 years with newly (within 60 days) diagnosed T1D', 'children with newly diagnosed T1D', 'Ninety-six children were randomised (probiotics, n=48; placebo n=48; median age 12.3 years']","['Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb12', 'placebo']","['area under the curve (AUC) of the C-peptide level during 2-hour responses to a mixed meal', 'frequency of thyroid autoimmunity', 'residual pancreatic beta-cell function', 'severe hypoglycemia or ketoacidosis', 'number of subjects with thyroid autoimmunity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C5191283', 'cui_str': '12.3'}]","[{'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}, {'cui': 'C1001866', 'cui_str': 'Bifidobacterium animalis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0202100', 'cui_str': 'Insulin C-peptide measurement'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0004364', 'cui_str': 'Autoimmune disease'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0030281', 'cui_str': 'Structure of beta Cell of islet'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",96.0,0.545389,There was no significant difference between the study groups for the AUC of the C-peptide level.,"[{'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Groele', 'Affiliation': ""Department of Paediatrics, The Children's Clinical Hospital Józef Polikarp Brudziński, Warsaw, Poland lgroele@wp.pl.""}, {'ForeName': 'Hania', 'Initials': 'H', 'LastName': 'Szajewska', 'Affiliation': 'Department of Paediatrics, The Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Mieczysław', 'Initials': 'M', 'LastName': 'Szalecki', 'Affiliation': ""Clinic of Endocrinology and Diabetology, The Children's Memorial Health Institute, Warsaw, Poland.""}, {'ForeName': 'Jolanta', 'Initials': 'J', 'LastName': 'Świderska', 'Affiliation': ""Clinic of Endocrinology and Diabetology, The Children's Memorial Health Institute, Warsaw, Poland.""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Wysocka-Mincewicz', 'Affiliation': ""Clinic of Endocrinology and Diabetology, The Children's Memorial Health Institute, Warsaw, Poland.""}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Ochocińska', 'Affiliation': ""Department of Biochemistry, Radioimmunology and Experimental Medicine, The Children's Memorial Health Institute, Warsaw, Poland.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Stelmaszczyk-Emmel', 'Affiliation': 'Deparment of Laboratory Diagnostics and Clinical Immunology of Developmental Age, The Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Urszula', 'Initials': 'U', 'LastName': 'Demkow', 'Affiliation': 'Deparment of Laboratory Diagnostics and Clinical Immunology of Developmental Age, The Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Szypowska', 'Affiliation': 'Department of Paediatrics, The Medical University of Warsaw, Warsaw, Poland.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2020-001523'] 2649,33823927,"Phase-IIa randomized, double-blind, sham-controlled, parallel group trial on anodal transcranial direct current stimulation (tDCS) over the left and right tempo-parietal junction in autism spectrum disorder-StimAT: study protocol for a clinical trial.","BACKGROUND Autism spectrum disorder (ASD) is characterized by impaired social communication and interaction, and stereotyped, repetitive behaviour and sensory interests. To date, there is no effective medication that can improve social communication and interaction in ASD, and effect sizes of behaviour-based psychotherapy remain in the low to medium range. Consequently, there is a clear need for new treatment options. ASD is associated with altered activation and connectivity patterns in brain areas which process social information. Transcranial direct current stimulation (tDCS) is a technique that applies a weak electrical current to the brain in order to modulate neural excitability and alter connectivity. Combined with specific cognitive tasks, it allows to facilitate and consolidate the respective training effects. Therefore, application of tDCS in brain areas relevant to social cognition in combination with a specific cognitive training is a promising treatment approach for ASD. METHODS A phase-IIa pilot randomized, double-blind, sham-controlled, parallel-group clinical study is presented, which aims at investigating if 10 days of 20-min multi-channel tDCS stimulation of the bilateral tempo-parietal junction (TPJ) at 2.0 mA in combination with a computer-based cognitive training on perspective taking, intention and emotion understanding, can improve social cognitive abilities in children and adolescents with ASD. The main objectives are to describe the change in parent-rated social responsiveness from baseline (within 1 week before first stimulation) to post-intervention (within 7 days after last stimulation) and to monitor safety and tolerability of the intervention. Secondary objectives include the evaluation of change in parent-rated social responsiveness at follow-up (4 weeks after end of intervention), change in other ASD core symptoms and psychopathology, social cognitive abilities and neural functioning post-intervention and at follow-up in order to explore underlying neural and cognitive mechanisms. DISCUSSION If shown, positive results regarding change in parent-rated social cognition and favourable safety and tolerability of the intervention will confirm tDCS as a promising treatment for ASD core-symptoms. This may be a first step in establishing a new and cost-efficient intervention for individuals with ASD. TRIAL REGISTRATION The trial is registered with the German Clinical Trials Register (DRKS), DRKS00014732 . Registered on 15 August 2018. PROTOCOL VERSION This study protocol refers to protocol version 1.2 from 24 May 2019.",2021,"To date, there is no effective medication that can improve social communication and interaction in ASD, and effect sizes of behaviour-based psychotherapy remain in the low to medium range.","['autism spectrum disorder-StimAT', 'Autism spectrum disorder (ASD', 'children and adolescents with ASD', 'individuals with ASD']","['Transcranial direct current stimulation (tDCS', '20-min multi-channel tDCS stimulation of the bilateral tempo-parietal junction (TPJ) at 2.0\u2009mA in combination with a computer-based cognitive training', 'anodal transcranial direct current stimulation (tDCS']","['change in other ASD core symptoms and psychopathology, social cognitive abilities and neural functioning post-intervention and at follow-up in order to explore underlying neural and cognitive mechanisms', 'social cognitive abilities', 'evaluation of change in parent-rated social responsiveness']","[{'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0076084', 'cui_str': '2,2,6,6-tetramethyl-4-piperidine-N-oxide'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}]",,0.173989,"To date, there is no effective medication that can improve social communication and interaction in ASD, and effect sizes of behaviour-based psychotherapy remain in the low to medium range.","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Luckhardt', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Frankfurt, Goethe University, Deutschordenstr.50, 60528, Frankfurt, Germany. Christina.Luckhardt@kgu.de.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Schütz', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Frankfurt, Goethe University, Deutschordenstr.50, 60528, Frankfurt, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Mühlherr', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Frankfurt, Goethe University, Deutschordenstr.50, 60528, Frankfurt, Germany.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Mössinger', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Frankfurt, Goethe University, Deutschordenstr.50, 60528, Frankfurt, Germany.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Boxhoorn', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Frankfurt, Goethe University, Deutschordenstr.50, 60528, Frankfurt, Germany.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Dempfle', 'Affiliation': 'Institute of Medical Informatics and Statistics (IMIS), Kiel University, Brunswiker Str. 10, 24105, Kiel, Germany.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Salvador', 'Affiliation': 'Neuroelectrics SLU, Av. Tibidabo 47 Bis, 08035, Barcelona, Spain.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Ruffini', 'Affiliation': 'Neuroelectrics SLU, Av. Tibidabo 47 Bis, 08035, Barcelona, Spain.'}, {'ForeName': 'Helena C', 'Initials': 'HC', 'LastName': 'Pereira', 'Affiliation': 'Coimbra Institute for Biomedical Imaging and Translational Research (CIBIT), ICNAS, Faculty of Medicine, Academic Clinical Centre, University of Coimbra (UC), Paco das Escolas, 3001 451, Coimbra, Portugal.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Castelo-Branco', 'Affiliation': 'Coimbra Institute for Biomedical Imaging and Translational Research (CIBIT), ICNAS, Faculty of Medicine, Academic Clinical Centre, University of Coimbra (UC), Paco das Escolas, 3001 451, Coimbra, Portugal.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Latinus', 'Affiliation': 'UMR 1253, iBrain, Université de Tours, Inserm, Centre de Pédopsychiatrie, CHRU Bretonneau, 2 bd Tonnellé, 37044, Tours Cedex 9, France.'}, {'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Bonnet-Brilhault', 'Affiliation': 'UMR 1253, iBrain, Université de Tours, Inserm, Centre de Pédopsychiatrie, CHRU Bretonneau, 2 bd Tonnellé, 37044, Tours Cedex 9, France.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Siemann', 'Affiliation': 'Clinic of Child and Adolescent Psychiatry and Psychotherapy, Protestant Hospital Bethel, EvKB, Remterweg 13a, 33617, Bielefeld, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Siniatchkin', 'Affiliation': 'Clinic of Child and Adolescent Psychiatry and Psychotherapy, Protestant Hospital Bethel, EvKB, Remterweg 13a, 33617, Bielefeld, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Ecker', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Frankfurt, Goethe University, Deutschordenstr.50, 60528, Frankfurt, Germany.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Freitag', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Frankfurt, Goethe University, Deutschordenstr.50, 60528, Frankfurt, Germany.'}]",Trials,['10.1186/s13063-021-05172-1'] 2650,33773476,"Instructional interventions for improving COVID-19 knowledge, attitudes, behaviors: Evidence from a large-scale RCT in India.","Seeking ways to encourage broad compliance with health guidelines during the pandemic, especially among youth, we test two hypotheses pertaining to the optimal design of instructional interventions for improving COVID-19-related knowledge, attitudes, and behaviors. We randomly assigned 8376 lower-middle income youth in urban India to three treatments: a concentrated and targeted fact-based, instructional intervention; a longer instructional intervention that provided the same facts along with underlying scientific concepts; and a control. Relative to existing efforts, we find that both instructional interventions increased COVID-19-related knowledge immediately after intervention. Relative to the shorter fact-based intervention, the longer intervention resulted in sustained improvements in knowledge, attitudes, and self-reported behavior. Instead of reducing attention and comprehension by youth, the longer scientific based treatment appears to have increased understanding and retention of the material. The findings are instrumental to understanding the design of instruction and communication in affecting compliance during this and future pandemics.",2021,"Relative to the shorter fact-based intervention, the longer intervention resulted in sustained improvements in knowledge, attitudes, and self-reported behavior.",['8376 lower-middle income youth in urban India to three treatments: a'],"['concentrated and targeted fact-based, instructional intervention; a longer instructional intervention that provided the same facts along with underlying scientific concepts; and a control']","['COVID-19-related knowledge', 'knowledge, attitudes, and self-reported behavior']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",8376.0,0.0284802,"Relative to the shorter fact-based intervention, the longer intervention resulted in sustained improvements in knowledge, attitudes, and self-reported behavior.","[{'ForeName': 'Dinsha', 'Initials': 'D', 'LastName': 'Mistree', 'Affiliation': 'Stanford University, Law School, 559 Nathan Abbott Way, Stanford, CA, 94305, USA. Electronic address: dmistree@law.stanford.edu.'}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Loyalka', 'Affiliation': 'Stanford University, Graduate School of Education and Freeman Spogli Institute for International Studies, Encina Hall East Wing Room 413, 616 Serra St., Stanford, CA, 94305, USA. Electronic address: loyalka@stanford.edu.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fairlie', 'Affiliation': 'University of California, Department of Economics, Santa Cruz, CA, 95064, USA. Electronic address: rfairlie@ucsc.edu.'}, {'ForeName': 'Ashutosh', 'Initials': 'A', 'LastName': 'Bhuradia', 'Affiliation': 'Freedom Employability Academy, Valmiki Temple One, Vasant Gaon, New Delhi, 110057, India; Harvard University, Graduate School of Education, 13 Appian Way, Cambridge, MA, 02138, USA. Electronic address: ashutosh_bhuradia@gsas.harvard.edu.'}, {'ForeName': 'Manyu', 'Initials': 'M', 'LastName': 'Angrish', 'Affiliation': 'Freedom Employability Academy, Valmiki Temple One, Vasant Gaon, New Delhi, 110057, India. Electronic address: manyuangrish@gmail.com.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Harker School, 500 Saratoga Ave., San Jose, CA, 95129, USA. Electronic address: jclin2.2009@gmail.com.'}, {'ForeName': 'Amar', 'Initials': 'A', 'LastName': 'Karoshi', 'Affiliation': 'Harker School, 500 Saratoga Ave., San Jose, CA, 95129, USA. Electronic address: wildkrattscrazy@gmail.com.'}, {'ForeName': 'Sara J', 'Initials': 'SJ', 'LastName': 'Yen', 'Affiliation': 'Harker School, 500 Saratoga Ave., San Jose, CA, 95129, USA. Electronic address: sarayen418@gmail.com.'}, {'ForeName': 'Jamsheed', 'Initials': 'J', 'LastName': 'Mistri', 'Affiliation': 'University of California, Department of Electrical Engineering and Computer Science, Berkeley, CA, 94720, USA. Electronic address: jmistri7@gmail.com.'}, {'ForeName': 'Vafa', 'Initials': 'V', 'LastName': 'Bayat', 'Affiliation': 'Bitscopic, Inc., 715 Colorado Avenue Suite B, Palo Alto, CA, 94303, USA. Electronic address: vafa@bitscopic.com.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2021.113846'] 2651,33773362,Treatment-resistant schizophrenia - A RCT on the effectiveness of repeated-dose sodium nitroprusside.,"OBJECTIVES Sodium nitroprusside (SNP) has shown efficacy in schizophrenia in early stages of the disease in a previous study, but in more recent studies it has not shown efficacy in patients with longer disease duration. In present study, we evaluated the efficacy of repeated-dose SNP in treatment-resistant schizophrenia. METHODS This was a double-blind, randomized, placebo-controlled trial. Twenty DSM-IV schizophrenia subjects, aged 18-60 years, with a history of nonresponse to ≥2 trials of antipsychotics of adequate dose and duration (≥6 weeks) were enrolled. Participants received SNP or placebo 4-hour infusions at 0.5 μg/kg/min. A total of 4 infusions and 4 follow-up evaluations, with an interval of 2 weeks, were performed. Severity of symptoms were assessed by using Positive and Negative Syndrome Scale (PANSS), Brief Psychiatric Rating Scale (BPRS-18) and Clinical Global Impression (CGI) scales. RESULTS SNP and placebo groups did not differ at baseline or in change from baseline for PANSS-total (F = 0.525; p = 0.841), PANSS-positive (F = 0.32; p = 0.958), PANSS-negative (F = 1.05; p = 0.483), BPRS (F = 0.615; p = 0.734), or CGI-S (F = 1.11; p = 0.416) scores. SNP was well tolerated and showed a good safety profile. CONCLUSION Although preliminary, the present findings suggest that SNP is not efficacious in TRS, reinforcing previous studies that have not demonstrated symptom improvement in chronic schizophrenia subjects. At this time, it is conceivable to speculate that efficacy of SNP might be restricted to early stages of disease.",2021,"RESULTS SNP and placebo groups did not differ at baseline or in change from baseline for PANSS-total (F = 0.525; p = 0.841), PANSS-positive (F = 0.32; p = 0.958), PANSS-negative (F = 1.05; p = 0.483), BPRS (F = 0.615; p = 0.734), or CGI-S (F = 1.11; p = 0.416) scores.","['patients with longer disease duration', 'Twenty DSM-IV schizophrenia subjects, aged 18-60\xa0years, with a history of nonresponse to ≥2 trials of antipsychotics of adequate dose and duration (≥6\xa0weeks) were enrolled', 'chronic schizophrenia subjects']","['SNP or placebo', 'sodium nitroprusside', 'SNP', 'placebo', 'Sodium nitroprusside (SNP']","['BPRS', 'Positive and Negative Syndrome Scale (PANSS), Brief Psychiatric Rating Scale (BPRS-18) and Clinical Global Impression (CGI) scales']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0221765', 'cui_str': 'Chronic schizophrenia'}]","[{'cui': 'C0037533', 'cui_str': 'Sodium nitroprusside'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0029941', 'cui_str': 'Brief psychiatric rating scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",20.0,0.190112,"RESULTS SNP and placebo groups did not differ at baseline or in change from baseline for PANSS-total (F = 0.525; p = 0.841), PANSS-positive (F = 0.32; p = 0.958), PANSS-negative (F = 1.05; p = 0.483), BPRS (F = 0.615; p = 0.734), or CGI-S (F = 1.11; p = 0.416) scores.","[{'ForeName': 'Marcelo P M', 'Initials': 'MPM', 'LastName': 'Adelino', 'Affiliation': 'CNS Unit, BR Trials - Clinical Research, São Paulo, Brazil; LiNC - Laboratory of Integrative Neuroscience, Department of Psychiatry, Universidade Federal de São Paulo, Sao Paulo, Brazil. Electronic address: marceloadelino221@gmail.com.'}, {'ForeName': 'Marcel V', 'Initials': 'MV', 'LastName': 'Nunes', 'Affiliation': 'CNS Unit, BR Trials - Clinical Research, São Paulo, Brazil; LiNC - Laboratory of Integrative Neuroscience, Department of Psychiatry, Universidade Federal de São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Marielle F Q', 'Initials': 'MFQ', 'LastName': 'Nunes', 'Affiliation': 'CNS Unit, BR Trials - Clinical Research, São Paulo, Brazil; LiNC - Laboratory of Integrative Neuroscience, Department of Psychiatry, Universidade Federal de São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Edivarley R', 'Initials': 'ER', 'LastName': 'Costa', 'Affiliation': 'CNS Unit, BR Trials - Clinical Research, São Paulo, Brazil; LiNC - Laboratory of Integrative Neuroscience, Department of Psychiatry, Universidade Federal de São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Ajub', 'Affiliation': 'Instituto Bairral de Psiquiatria, Itapira, Brazil.'}, {'ForeName': 'Milan P B', 'Initials': 'MPB', 'LastName': 'Mitrovitch', 'Affiliation': 'CNS Unit, BR Trials - Clinical Research, São Paulo, Brazil.'}, {'ForeName': 'Juliana M', 'Initials': 'JM', 'LastName': 'Ushirohira', 'Affiliation': 'Department of Neuroscience and Behavior, University of São Paulo, Ribeirão Preto, Brazil; National Institute of Science and Technology in Translational Medicine, CNPq/FAPESP/CAPES, Brazil.'}, {'ForeName': 'Lucas C', 'Initials': 'LC', 'LastName': 'Quarantini', 'Affiliation': 'Hospital Universitário Professor Edgard Santos, Serviço de Psiquiatria, Universidade Federal da Bahia, Salvador, Brazil; Laboratório de Neuropsicofarmacologia, Universidade Federal da Bahia, Salvador, Bahia, Brazil; Programa de Pós-Graduação em Medicina e Saúde, Faculdade de Medicina da Bahia, Universidade Federal da Bahia, Salvador, Brazil.'}, {'ForeName': 'Jaime C E', 'Initials': 'JCE', 'LastName': 'Hallak', 'Affiliation': 'Department of Neuroscience and Behavior, University of São Paulo, Ribeirão Preto, Brazil; National Institute of Science and Technology in Translational Medicine, CNPq/FAPESP/CAPES, Brazil.'}, {'ForeName': 'Acioly L T', 'Initials': 'ALT', 'LastName': 'Lacerda', 'Affiliation': 'CNS Unit, BR Trials - Clinical Research, São Paulo, Brazil; LiNC - Laboratory of Integrative Neuroscience, Department of Psychiatry, Universidade Federal de São Paulo, Sao Paulo, Brazil; National Institute of Science and Technology in Translational Medicine, CNPq/FAPESP/CAPES, Brazil; PRODAF - Programa de Transtornos Afetivos, Department of Psychiatry, Universidade Federal de São Paulo, São Paulo, Brazil.'}]",Schizophrenia research,['10.1016/j.schres.2021.03.005'] 2652,33773361,Transcranial direct current stimulation (tDCS) may reduce the expired CO concentration among opioid users who smoke cigarettes: a randomized sham-controlled study.,"Transcranial direct current stimulation (tDCS) could be a potential treatment for nicotine dependency. Little is known with regards to the efficacy of this treatment in cigarette-smoking patients with heroin dependency. In this sham-controlled study, we probed the effect of 5-day, 20-min, 2-mA-intensity tDCS treatment on the outcomes of cigarette-smoking. Our objectives are to examine the effects of tDCS on two outcomes: objective expired CO concentration and subjective self-reported number of cigarettes smoked per day. A total of 30 patients were randomized into active or sham control groups. The stimulation site was randomized to anodal stimulation of the left dorsal lateral prefrontal cortex or the orbital frontal cortex. The expired CO concentration was recorded. The patients also reported their cigarette consumption and level of craving prior to each 5-day treatment period and after 5 days of follow-up. tDCS was found to be effective in terms of reducing the expired CO concentration, and both groups demonstrated reduced numbers of cigarettes smoked. However, no significant group difference was found with regards to craving tendency. tDCS may affect objective outcomes related to cigarette-smoking among patients with heroin dependence.",2021,"tDCS was found to be effective in terms of reducing the expired CO concentration, and both groups demonstrated reduced numbers of cigarettes smoked.","['cigarette-smoking patients with heroin dependency', '30 patients', 'opioid users who smoke cigarettes', 'patients with heroin dependence']","['Transcranial direct current stimulation (tDCS', 'tDCS', '2-mA-intensity tDCS treatment']","['cigarette consumption and level of craving', 'craving tendency', 'expired CO concentration']","[{'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011892', 'cui_str': 'Heroin'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0019337', 'cui_str': 'Heroin dependence'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0459840', 'cui_str': 'Cigarette consumption'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",30.0,0.0376573,"tDCS was found to be effective in terms of reducing the expired CO concentration, and both groups demonstrated reduced numbers of cigarettes smoked.","[{'ForeName': 'Shih-Hsien', 'Initials': 'SH', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Institute of Behavioral Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Po See', 'Initials': 'PS', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Institute of Behavioral Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Department of Psychiatry, National Cheng Kung University Hospital, Dou-Liou Branch, Yunlin, Taiwan.'}, {'ForeName': 'Kao Chin', 'Initials': 'KC', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Wei Hung', 'Initials': 'WH', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Department of Psychiatry, National Cheng Kung University Hospital, Dou-Liou Branch, Yunlin, Taiwan.'}, {'ForeName': 'Tzu-Yun', 'Initials': 'TY', 'LastName': 'Wang', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Yen Kuang', 'Initials': 'YK', 'LastName': 'Yang', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Institute of Behavioral Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Department of Psychiatry, Tainan Hospital, Ministry of Health and Welfare, Tainan, Taiwan. Electronic address: ykyang@mail.ncku.edu.tw.'}]",Psychiatry research,['10.1016/j.psychres.2021.113874'] 2653,33823928,Effect of the combination of automated peripheral mechanical stimulation and physical exercise on aerobic functional capacity and cardiac autonomic control in patients with Parkinson's disease: a randomized clinical trial protocol.,"BACKGROUND Automated peripheral mechanical stimulation (AMPS) has been proposed as a new complementary therapy with potential for improving motor and cardiovascular abnormalities in Parkinson's disease (PD). However, AMPS long-term effects and its combination with physical exercise are unknown. Thus, this study aims to compare the effects of a program of 12 weeks of physical exercise with a 12-week intervention program combining physical exercise and AMPS on the aerobic capacity, cardiac autonomic control, and gait parameters in patients with PD. METHODS A randomized, controlled clinical trial will be conducted. Older volunteers with PD will be randomly assigned to one of the two groups studied: (1) exercise or (2) AMPS + exercise. Both groups will undergo an exercise program of 24 sessions, for 12 weeks, performed twice a week. Before exercise sessions, the group AMPS + exercise will receive a session of active AMPS, while the group exercise will receive an AMPS sham intervention. Shapiro-Wilk's and Levene's tests will be used to check for data normality and homogeneity, respectively. In case parametric assumptions are fulfilled, per-protocol and intention-to-treat analyses will be performed using a mixed model analysis of variance to check for group*time interaction. Significance level will be set at 5%. DISCUSSION Several non-pharmacological treatment modalities have been proposed for PD, focusing primarily on the reduction of motor and musculoskeletal disorders. Regular exercise and motor training have been shown to be effective in improving quality of life. However, treatment options in general remain limited given the high prevalence and adverse impact of these disorders. So, developing new strategies that can potentiate the improvement of motor disabilities and also improve non-motor symptoms in PD is relevant. It is expected that the participants from both groups will improve their quality of life, gait parameters, and their cardiac autonomic control, with greater improvements being observed in the group combining active AMPS and physical exercise. TRIAL REGISTRATION ClinicalTrials.gov NCT04251728 . Registered on February 05, 2020.",2021,"It is expected that the participants from both groups will improve their quality of life, gait parameters, and their cardiac autonomic control, with greater improvements being observed in the group combining active AMPS and physical exercise. ","[""patients with Parkinson's disease"", 'patients with PD', ""Parkinson's disease (PD"", 'Older volunteers with PD']","['physical exercise with a 12-week intervention program combining physical exercise and AMPS', 'exercise or (2) AMPS + exercise', 'automated peripheral mechanical stimulation and physical exercise', 'Regular exercise and motor training', 'peripheral mechanical stimulation (AMPS', 'AMPS sham intervention']","['aerobic functional capacity and cardiac autonomic control', 'quality of life', 'aerobic capacity, cardiac autonomic control, and gait parameters']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C1285354', 'cui_str': 'Mechanical stimulation'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0265469,"It is expected that the participants from both groups will improve their quality of life, gait parameters, and their cardiac autonomic control, with greater improvements being observed in the group combining active AMPS and physical exercise. ","[{'ForeName': 'Nicolle', 'Initials': 'N', 'LastName': 'Zelada-Astudillo', 'Affiliation': 'Laboratory of Clinical Research in Kinesiology, Department of Kinesiology, Universidad Católica del Maule, Talca, Chile.'}, {'ForeName': 'Vinicius Christianini', 'Initials': 'VC', 'LastName': 'Moreno', 'Affiliation': 'São Paulo State University (UNESP), Graduate Program in Movement Sciences, Department of Physical Education, Human Movement Research Laboratory (MOVI-LAB), Bauru, Brazil.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Herrera-Santelices', 'Affiliation': 'Laboratory of Clinical Research in Kinesiology, Department of Kinesiology, Universidad Católica del Maule, Talca, Chile.'}, {'ForeName': 'Fabio Augusto', 'Initials': 'FA', 'LastName': 'Barbieri', 'Affiliation': 'São Paulo State University (UNESP), Graduate Program in Movement Sciences, Department of Physical Education, Human Movement Research Laboratory (MOVI-LAB), Bauru, Brazil.'}, {'ForeName': 'Antonio Roberto', 'Initials': 'AR', 'LastName': 'Zamunér', 'Affiliation': 'Laboratory of Clinical Research in Kinesiology, Department of Kinesiology, Universidad Católica del Maule, Talca, Chile. beto.zam@gmail.com.'}]",Trials,['10.1186/s13063-021-05177-w'] 2654,33823924,"Ultrasound-guided erector spinae plane block versus thoracic paravertebral block on postoperative analgesia after laparoscopic nephroureterectomy: study protocol of a randomized, double-blinded, non-inferiority design trial.","INTRODUCTION Erector spinae plane block (ESPB) is a novel inter-fascial plane block, which is applied more and more in postoperative pain control, especially in chest surgery. Regional block is advocated in order to decrease opioid consumption and improve analgesia in urological surgery. Therefore, we aimed to explore whether ESPB would have similar analgesia compared with thoracic paravertebral block (TPVB) in laparoscopic nephroureterectomy. METHODS AND ANALYSIS This prospective, randomized, double-blinded, non-inferiority trial will enroll 166 patients undergoing laparoscopic nephroureterectomy. Participants will be randomly assigned 1:1 into receiving ESPB or TPVB before surgery. Both ultrasound-guided ESPB and TPVB will be performed with an injection of 0.375% ropivacaine 0.4 ml/kg before anesthesia induction. Standardized patients controlled intravenous analgesia (PCIA) will be applied for each patient. The primary endpoint is the joint of cumulative 24 h opioid (sufentanil) consumption and average pain score via numeric rating scale (NRS) at 24 h after surgery. Secondary endpoints include rescued analgesic demand, cumulative opioid consumption, and pain NRS scores at different preset timepoints within 48 h after surgery. Other predefined outcomes include clinical features of blockage, quality of recovery, subjective sleep quality, time to ambulation and diet, and adverse events, as well as length of stay in hospital and anesthesia cost. DISCUSSION Previous studies investigating the analgesic efficacy of ESPB only concentrated on a single endpoint for postoperative pain evaluation, while studies focusing on the direct comparison between ESPB and TPVB in urological surgery are still lacking. Our study is the first trial in non-inferiority design of comparing ESPB and TPVB in patient undergoing laparoscopic nephroureterectomy, and the primary outcome is the joint endpoint of opioid consumption and pain NRS score. TRIAL REGISTRATION Chinese Clinical Trial Registry ChiCTR 2000031916 . Registered on 14 April 2020.",2021,"Secondary endpoints include rescued analgesic demand, cumulative opioid consumption, and pain NRS scores at different preset timepoints within 48 h after surgery.","['patient undergoing laparoscopic nephroureterectomy', '166 patients undergoing']","['intravenous analgesia (PCIA', 'ESPB or TPVB', 'ESPB and TPVB', 'ESPB', 'ropivacaine', 'thoracic paravertebral block (TPVB', 'laparoscopic nephroureterectomy', 'Erector spinae plane block (ESPB', 'Ultrasound-guided erector spinae plane block versus thoracic paravertebral block']","['analgesic demand, cumulative opioid consumption, and pain NRS scores', 'joint of cumulative 24\u2009h opioid (sufentanil) consumption and average pain score via numeric rating scale (NRS', 'clinical features of blockage, quality of recovery, subjective sleep quality, time to ambulation and diet, and adverse events, as well as length of stay in hospital and anesthesia cost', 'opioid consumption and pain NRS score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2111394', 'cui_str': 'Laparoscopic nephroureterectomy'}, {'cui': 'C5191361', 'cui_str': '166'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C2111394', 'cui_str': 'Laparoscopic nephroureterectomy'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",166.0,0.751008,"Secondary endpoints include rescued analgesic demand, cumulative opioid consumption, and pain NRS scores at different preset timepoints within 48 h after surgery.","[{'ForeName': 'Zhen-Zhen', 'Initials': 'ZZ', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital, No. 8, Xishiku Street, Beijing, 100034, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital, No. 8, Xishiku Street, Beijing, 100034, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital, No. 8, Xishiku Street, Beijing, 100034, China.'}, {'ForeName': 'Zheng-Ye', 'Initials': 'ZY', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital, No. 8, Xishiku Street, Beijing, 100034, China.'}, {'ForeName': 'Lin-Lin', 'Initials': 'LL', 'LastName': 'Song', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital, No. 8, Xishiku Street, Beijing, 100034, China.'}, {'ForeName': 'Xue-Ying', 'Initials': 'XY', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital, No. 8, Xishiku Street, Beijing, 100034, China. zhanghong40@hotmail.com.'}]",Trials,['10.1186/s13063-021-05173-0'] 2655,33823907,How 'place' matters for addressing the HIV epidemic: evidence from the HPTN 071 (PopART) cluster-randomised controlled trial in Zambia and South Africa.,"BACKGROUND In a cluster-randomised trial (CRT) of combination HIV prevention (HPTN 071 (PopART)) in 12 Zambian communities and nine South African communities, carried out from 2012 to 2018, the intervention arm A that offered HIV treatment irrespective of CD4 count did not have a significant impact on population level HIV incidence. Intervention arm B, where HIV incidence was reduced by 30%, followed national guidelines that mid trial (2016) changed from starting HIV treatment according to a CD4 threshold of 500 to universal treatment. Using social science data on the 21 communities, we consider how place (community context) might have influenced the primary outcome result. METHODS A social science component documented longitudinally the context of trial communities. Data were collected through rapid qualitative assessment, interviews, group discussions and observations. There were a total of 1547 participants and 1127 observations. Using these data, literature and a series of qualitative analysis steps, we identified key community characteristics of relevance to HIV and triangulated these with HIV community level incidence. RESULTS Two interdependent social factors were relevant to communities' capability to manage HIV: stability/instability and responsiveness/resistance. Key components of stability were social cohesion; limited social change; a vibrant local economy; better health, education and recreational services; strong institutional presence; established middle-class residents; predictable mobility; and less poverty and crime. Key components of responsiveness were community leadership being open to change, stronger history of HIV initiatives, willingness to take up HIV services, less HIV-related stigma and a supported and enterprising youth population. There was a clear pattern of social factors across arms. Intervention arm A communities were notably more resistant and unstable. Intervention arm B communities were overall more responsive and stable. CONCLUSIONS In the specific case of the dissonant primary outcome results from the HPTN 071 (PopART) trial, the chance allocation of less stable, less responsive communities to arm A compared to arm B may explain some of the apparently smaller impact of the intervention in arm A. Stability and responsiveness appear to be two key social factors that may be relevant to secular trends in HIV incidence. We advocate for a systematic approach, using these factors as a framework, to community context in CRTs and monitoring HIV prevention efforts. TRIAL REGISTRATION ClinicalTrials.gov NCT01900977 . Registered on July 17, 2013.",2021,"Key components of responsiveness were community leadership being open to change, stronger history of HIV initiatives, willingness to take up HIV services, less HIV-related stigma and a supported and enterprising youth population.","['12 Zambian communities and nine South African communities, carried out from 2012 to 2018', '1547 participants and 1127 observations']",['combination HIV prevention (HPTN 071 (PopART'],"['HIV incidence', 'population level HIV incidence', 'CD4 count']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}]",1547.0,0.150182,"Key components of responsiveness were community leadership being open to change, stronger history of HIV initiatives, willingness to take up HIV services, less HIV-related stigma and a supported and enterprising youth population.","[{'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Bond', 'Affiliation': 'Department of Global Health and Development, Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine (LSHTM), 15-17 Tavistock Place, London, WC1H 9SH, UK. Virginia.Bond@lshtm.ac.uk.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Hoddinott', 'Affiliation': 'Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, P.O. Box 241, Cape Town, 8000, South Africa.'}, {'ForeName': 'Lario', 'Initials': 'L', 'LastName': 'Viljoen', 'Affiliation': 'Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, P.O. Box 241, Cape Town, 8000, South Africa.'}, {'ForeName': 'Fredrick', 'Initials': 'F', 'LastName': 'Ngwenya', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Ridgeway Campus, P.O. Box 50697, Lusaka, Zambia.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'Simuyaba', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Ridgeway Campus, P.O. Box 50697, Lusaka, Zambia.'}, {'ForeName': 'Bwalya', 'Initials': 'B', 'LastName': 'Chiti', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Ridgeway Campus, P.O. Box 50697, Lusaka, Zambia.'}, {'ForeName': 'Rhoda', 'Initials': 'R', 'LastName': 'Ndubani', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Ridgeway Campus, P.O. Box 50697, Lusaka, Zambia.'}, {'ForeName': 'Nozizwe', 'Initials': 'N', 'LastName': 'Makola', 'Affiliation': 'Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, P.O. Box 241, Cape Town, 8000, South Africa.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Donnell', 'Affiliation': 'Fred Hutchinson Cancer Research Center, 1100 Fairview Ave. N., P.O. Box 19024, Seattle, WA, 98109-1024, USA.'}, {'ForeName': 'Ab', 'Initials': 'A', 'LastName': 'Schaap', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Ridgeway Campus, P.O. Box 50697, Lusaka, Zambia.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Floyd', 'Affiliation': 'Department of Infectious Disease Epidemiology, Faculty of Epidemiology and Population Health, LSHTM, Keppel Street, London, WC17HT, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hargreaves', 'Affiliation': 'Centre for Evaluation, Faculty of Public Health and Policy, LSHTM, Keppel Street, London, WC17HT, UK.'}, {'ForeName': 'Kwame', 'Initials': 'K', 'LastName': 'Shanaube', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Ridgeway Campus, P.O. Box 50697, Lusaka, Zambia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Fidler', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, Imperial College, South Kensington, London, SW7 2BU, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bock', 'Affiliation': 'Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, P.O. Box 241, Cape Town, 8000, South Africa.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Ayles', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Ridgeway Campus, P.O. Box 50697, Lusaka, Zambia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hayes', 'Affiliation': 'Department of Infectious Disease Epidemiology, Faculty of Epidemiology and Population Health, LSHTM, Keppel Street, London, WC17HT, UK.'}, {'ForeName': 'Musonda', 'Initials': 'M', 'LastName': 'Simwinga', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Ridgeway Campus, P.O. Box 50697, Lusaka, Zambia.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Seeley', 'Affiliation': 'Department of Global Health and Development, Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine (LSHTM), 15-17 Tavistock Place, London, WC1H 9SH, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-021-05198-5'] 2656,33755728,Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults With Overweight or Obesity: The STEP 4 Randomized Clinical Trial.,"Importance The effect of continuing vs withdrawing treatment with semaglutide, a glucagon-like peptide 1 receptor agonist, on weight loss maintenance in people with overweight or obesity is unknown. Objective To compare continued once-weekly treatment with subcutaneous semaglutide, 2.4 mg, with switch to placebo for weight maintenance (both with lifestyle intervention) in adults with overweight or obesity after a 20-week run-in with subcutaneous semaglutide titrated to 2.4 mg weekly. Design, Setting, and Participants Randomized, double-blind, 68-week phase 3a withdrawal study conducted at 73 sites in 10 countries from June 2018 to March 2020 in adults with body mass index of at least 30 (or ≥27 with ≥1 weight-related comorbidity) and without diabetes. Interventions A total of 902 participants received once-weekly subcutaneous semaglutide during run-in. After 20 weeks (16 weeks of dose escalation; 4 weeks of maintenance dose), 803 participants (89.0%) who reached the 2.4-mg/wk semaglutide maintenance dose were randomized (2:1) to 48 weeks of continued subcutaneous semaglutide (n = 535) or switched to placebo (n = 268), plus lifestyle intervention in both groups. Main Outcomes and Measures The primary end point was percent change in body weight from week 20 to week 68; confirmatory secondary end points were changes in waist circumference, systolic blood pressure, and physical functioning (assessed using the Short Form 36 Version 2 Health Survey, Acute Version [SF-36]). Results Among 803 study participants who completed the 20-week run-in period (with a mean weight loss of 10.6%) and were randomized (mean age, 46 [SD, 12] years; 634 [79%] women; mean body weight, 107.2 kg [SD, 22.7 kg]), 787 participants (98.0%) completed the trial and 741 (92.3%) completed treatment. With continued semaglutide, mean body weight change from week 20 to week 68 was -7.9% vs +6.9% with the switch to placebo (difference, -14.8 [95% CI, -16.0 to -13.5] percentage points; P < .001). Waist circumference (-9.7 cm [95% CI, -10.9 to -8.5 cm]), systolic blood pressure (-3.9 mm Hg [95% CI, -5.8 to -2.0 mm Hg]), and SF-36 physical functioning score (2.5 [95% CI, 1.6-3.3]) also improved with continued subcutaneous semaglutide vs placebo (all P < .001). Gastrointestinal events were reported in 49.1% of participants who continued subcutaneous semaglutide vs 26.1% with placebo; similar proportions discontinued treatment because of adverse events with continued semaglutide (2.4%) and placebo (2.2%). Conclusions and Relevance Among adults with overweight or obesity who completed a 20-week run-in period with subcutaneous semaglutide, 2.4 mg once weekly, maintaining treatment with semaglutide compared with switching to placebo resulted in continued weight loss over the following 48 weeks. Trial Registration ClinicalTrials.gov Identifier: NCT03548987.",2021,"Waist circumference (-9.7 cm [95% CI, -10.9 to -8.5 cm]), systolic blood pressure","['803 participants (89.0%) who reached the 2.4-mg/wk semaglutide maintenance dose', 'adults with overweight or obesity after a 20-week run-in with subcutaneous semaglutide titrated to 2.4 mg weekly', 'people with overweight or obesity', 'adults with overweight or obesity', '803 study participants who completed the 20-week run-in period (with a mean weight loss of 10.6%) and were randomized (mean age, 46 [SD, 12] years; 634 [79%] women; mean body weight, 107.2 kg [SD, 22.7 kg]), 787 participants (98.0%) completed the trial and 741 (92.3%) completed treatment', '902 participants received', '68-week phase 3a withdrawal study conducted at 73 sites in 10 countries from June 2018 to March 2020 in adults with body mass index of at least 30 (or ≥27 with ≥1 weight-related comorbidity) and without diabetes', 'Adults With Overweight or Obesity']","['plus lifestyle intervention', 'continued subcutaneous semaglutide (n\u2009=\u2009535) or switched to placebo', 'subcutaneous semaglutide, 2.4 mg, with switch to placebo for weight maintenance (both with lifestyle intervention', 'Continued Weekly Subcutaneous Semaglutide vs Placebo', 'glucagon-like peptide 1 receptor agonist', 'placebo', 'once-weekly subcutaneous semaglutide']","['percent change in body weight', 'weight loss maintenance', 'Gastrointestinal events', 'systolic blood pressure', 'Weight Loss Maintenance', 'waist circumference, systolic blood pressure, and physical functioning (assessed using the Short Form 36 Version 2 Health Survey, Acute Version [SF-36', 'mean body weight change', 'weight loss', 'SF-36 physical functioning score', 'Waist circumference']","[{'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C3714445', 'cui_str': 'Maintenance dose'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",803.0,0.567717,"Waist circumference (-9.7 cm [95% CI, -10.9 to -8.5 cm]), systolic blood pressure","[{'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Rubino', 'Affiliation': 'Washington Center for Weight Management, Arlington, Virginia.'}, {'ForeName': 'Niclas', 'Initials': 'N', 'LastName': 'Abrahamsson', 'Affiliation': 'Endocrinology Unit, Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, England.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Hesse', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Greenway', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Jensen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Ildiko', 'Initials': 'I', 'LastName': 'Lingvay', 'Affiliation': 'Departments of Internal Medicine/Endocrinology and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center at Medical City, Dallas, Texas.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Rubio', 'Affiliation': 'Department of Endocrinology and Nutrition, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Faculty of Medicine, Universidad Complutense, Madrid, Spain.'}, {'ForeName': 'Gottfried', 'Initials': 'G', 'LastName': 'Rudofsky', 'Affiliation': 'Department of Endocrinology and Metabolic Diseases, Kantonsspital Olten, Olten, Switzerland.'}, {'ForeName': 'Sayeh', 'Initials': 'S', 'LastName': 'Tadayon', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Dror', 'Initials': 'D', 'LastName': 'Dicker', 'Affiliation': 'Internal Medicine Department and Obesity Clinic, Hasharon Hospital-Rabin Medical Center, Petach-Tikva, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2021.3224'] 2657,33759278,Visual illusions modulate body perception disturbance and pain in Complex Regional Pain Syndrome: A randomized trial.,"BACKGROUND Effective treatment of longstanding Complex Regional Pain Syndrome (CRPS) is a challenge, as causal mechanisms remain elusive. People with CRPS frequently report distorted subjective perceptions of their affected limb. Evidence of pain reduction when the affected limb is visually altered in size suggests that visual illusions used to target central processing could restore coherence of this disrupted limb representation. We hypothesized that using virtual reality that alters hand image to match the patient's desired hand appearance would improve body perception disturbance and pain. Also, repeated exposure would maintain any therapeutic effect. METHODS A blinded randomized controlled trial of 45 participants with refractory upper-limb CRPS and body perception disturbance (BPD) viewed a digital image of their affected hand for 1 min. The image was digitally altered according to the patient's description of how they desired their hand to look in the experimental group and unaltered in the control group. BPD and pain were measured pre- and post-intervention. A subgroup was followed up 2 weeks after a course of repeated interventions. RESULTS BPD (mean-6, ±SD 7.9, p = 0.036, effect size [ES] = 0.6) and pain intensity (mean-0.43, ±SD 1.3, p = 0.047, ES = 0.5) reduced in 23 participants after single exposure compared to controls (n = 22). At follow-up, the subgroup (experimental n = 21; control n = 18) showed sustained pain reduction only (p = 0.037, ±SD 1.9, ES = 0.7), with an overall 1.2 decrease on an 11-point scale. CONCLUSIONS Visually changing the CRPS hand to a desired appearance modulates BPD and pain suggesting therapeutic potential for those with refractory CRPS. Further research to optimize this therapeutic effect is required. SIGNIFICANCE Visual bodily illusions that change the shape and appearance of the painful CRPS hand to that desired by the patient result in a rapid amelioration of pain and body perception disturbance in people with longstanding CRPS. These findings highlight the future potential of this drug-free approach in the treatment of refractory CRPS.",2021,"At follow-up, the subgroup (experimental n=21; control n=18) showed sustained pain reduction only (p=0.037, ±SD 1.9, ES=0.7), with an overall 1.2 decrease on an 11-point scale. ","['45 participants with refractory upper-limb CRPS and body perception disturbance (BPD) viewed a digital image of their affected hand for one minute', 'longstanding Complex Regional Pain Syndrome (CRPS', 'Complex Regional Pain Syndrome', '23 participants after single exposure compared to controls (n=22']",['Visual illusions'],"['BPD and pain', 'body perception disturbance and pain', '11-point scale', 'sustained pain reduction', 'pain intensity', 'pain reduction']","[{'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0458219', 'cui_str': 'Complex regional pain syndrome'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0233746', 'cui_str': 'Disturbance of perception'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0751246', 'cui_str': 'Illusions, Visual'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0233746', 'cui_str': 'Disturbance of perception'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",45.0,0.0796438,"At follow-up, the subgroup (experimental n=21; control n=18) showed sustained pain reduction only (p=0.037, ±SD 1.9, ES=0.7), with an overall 1.2 decrease on an 11-point scale. ","[{'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Lewis', 'Affiliation': 'Royal National Hospital for Rheumatic Diseases, Royal United Hospitals Bath NHS Trust, Bath, UK.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Newport', 'Affiliation': 'University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Taylor', 'Affiliation': 'University of Exeter, Exeter, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Smith', 'Affiliation': 'Royal National Hospital for Rheumatic Diseases, Royal United Hospitals Bath NHS Trust, Bath, UK.'}, {'ForeName': 'Candida S', 'Initials': 'CS', 'LastName': 'McCabe', 'Affiliation': 'University of the West of England, Bristol, UK.'}]","European journal of pain (London, England)",['10.1002/ejp.1766'] 2658,33757745,The Efficacy of 4% Articaine Versus 2% Lidocaine in Inducing Palatal Anesthesia for Tooth Extraction in Different Maxillary Regions.,"PURPOSE This study was conducted to ascertain the efficacy of buccal injection of articaine compared to lidocaine in inducing palatal anesthesia in different maxillary regions. MATERIALS AND METHODS This double-blinded, randomized clinical trial included 300 patients who referred for extraction of 1 maxillary tooth. The patients were categorized into 3 strata according to the extraction area (anterior, premolar, molar), and then randomly assigned to 2 groups based on the administered medication. The first group received buccal infiltration by 0.6 mL of 2% lidocaine, whereas the second group was buccally administered using 0.6 mL of 4% articaine. After a waiting period of 2 minutes, the failure or success in achieving palatal anesthesia was assessed by the instrumentation technique. In cases of failed anesthesia, an additional 0.6 mL of the same anesthetic was given, and the procedure was repeated if palatal anesthesia was not attained after a 2-minute delay. If pain remained 2 minutes after the third injection, a supplemental palatal infiltration was administered and the extraction was attempted. RESULTS The success rate of buccal infiltration in achieving palatal anesthesia was 82.7% in the articaine group and 1.3% in the lidocaine group. There was a significant difference in the success rate and drug volume required to induce palatal anesthesia between the 2 groups (P < .001), but no significant difference was found between different maxillary regions, using either of the medications (P > .05). CONCLUSIONS Articaine can be considered as a suitable alternative to lidocaine for eliminating painful palatal infiltration in the extraction of maxillary teeth.",2021,The success rate of buccal infiltration in achieving palatal anesthesia was 82.7% in the articaine group and 1.3% in the lidocaine group.,"['300 patients who referred for extraction of 1 maxillary tooth', 'palatal anesthesia in different maxillary regions', 'Palatal Anesthesia for Tooth Extraction in Different Maxillary Regions']","['articaine', 'lidocaine', 'Articaine', 'Lidocaine']","['buccal infiltration', 'success rate of buccal infiltration', 'failure or success in achieving palatal anesthesia', 'success rate and drug volume required to induce palatal anesthesia']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0227028', 'cui_str': 'Structure of maxillary teeth'}, {'cui': 'C4285979', 'cui_str': 'Palatal anaesthesia'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}]","[{'cui': 'C1608295', 'cui_str': 'Articaine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C4285979', 'cui_str': 'Palatal anaesthesia'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",300.0,0.0763637,The success rate of buccal infiltration in achieving palatal anesthesia was 82.7% in the articaine group and 1.3% in the lidocaine group.,"[{'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Gholami', 'Affiliation': 'Associate Professor, Department of Oral and Maxillofacial Surgery, School of Dentistry, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Banihashemrad', 'Affiliation': 'Associate Professor, Department of Periodontics, School of Dentistry, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mohammadzadeh', 'Affiliation': 'Undergraduate Student, Student Research Committee, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Ahrari', 'Affiliation': 'Associate Professor, Dental Research Center, School of Dentistry, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: Farzaneh.Ahrari@Gmail.com.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2021.02.019'] 2659,33757719,Dry cupping therapy is not superior to sham cupping to improve clinical outcomes in people with non-specific chronic low back pain: a randomised trial.,"QUESTION What are the effects of dry cupping on pain intensity, physical function, functional mobility, trunk range of motion, perceived overall effect, quality of life, psychological symptoms and medication use in individuals with chronic non-specific low back pain? DESIGN Randomised controlled trial with concealed allocation, intention-to-treat analysis and blinding of participants and assessors. PARTICIPANTS Ninety participants with chronic non-specific low back pain. INTERVENTIONS The experimental group (n = 45) received dry cupping therapy, with cups bilaterally positioned parallel to the L1 to L5 vertebrae. The control group (n = 45) received sham cupping therapy. The interventions were applied once a week for 8 weeks. OUTCOME MEASURES Participants were assessed before and after the first treatment session, and after 4 and 8 weeks of intervention. The primary outcome was pain intensity, measured with the numerical pain scale at rest, during fast walking and during trunk flexion. Secondary outcomes were physical function, functional mobility, trunk range of motion, perceived overall effect, quality of life, psychological symptoms and medication use. RESULTS On a 0-to-10 scale, the between-group difference in pain severity at rest was negligible: MD 0.0 (95% CI -0.9 to 1.0) immediately after the first treatment, 0.4 (95% CI -0.5 to 1.5) at 4 weeks and 0.6 (95% CI -0.4 to 1.6) at 8 weeks. Similar negligible effects were observed on pain severity during fast walking or trunk flexion. Negligible effects were also found on physical function, functional mobility and perceived overall effect, where mean estimates and their confidence intervals all excluded worthwhile effects. No worthwhile benefits could be confirmed for any of the remaining secondary outcomes. CONCLUSION Dry cupping therapy was not superior to sham cupping for improving pain, physical function, mobility, quality of life, psychological symptoms or medication use in people with non-specific chronic low back pain. PROTOCOL REGISTRATION NUMBER NCT03909672.",2021,"CONCLUSION Dry cupping therapy was not superior to sham cupping for improving pain, physical function, mobility, quality of life, psychological symptoms or medication use in people with non-specific chronic low back pain. ","['Ninety participants with chronic non-specific low back pain', 'people with non-specific chronic low back pain', 'individuals with chronic non-specific low back pain']","['dry cupping therapy, with cups bilaterally positioned parallel to the L1 to L5 vertebrae', 'Dry cupping therapy', 'sham cupping therapy']","['physical function, functional mobility and perceived overall effect', 'physical function, functional mobility, trunk range of motion, perceived overall effect, quality of life, psychological symptoms and medication use', 'pain intensity, physical function, functional mobility, trunk range of motion, perceived overall effect, quality of life, psychological symptoms and medication use', 'pain intensity, measured with the numerical pain scale at rest, during fast walking and during trunk flexion', 'pain, physical function, mobility, quality of life, psychological symptoms or medication use', 'pain severity', 'clinical outcomes']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C5197695', 'cui_str': 'Cupping Treatment'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",90.0,0.259286,"CONCLUSION Dry cupping therapy was not superior to sham cupping for improving pain, physical function, mobility, quality of life, psychological symptoms or medication use in people with non-specific chronic low back pain. ","[{'ForeName': 'Hugo Jário', 'Initials': 'HJ', 'LastName': 'Almeida Silva', 'Affiliation': 'Postgraduate Program in Rehabilitation Sciences, Faculty of Health Sciences of Trairi, Federal University of Rio Grande do Norte (UFRN), Santa Cruz, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Germanna Medeiros', 'Initials': 'GM', 'LastName': 'Barbosa', 'Affiliation': 'Faculty of Health Sciences of Trairi, Federal University of Rio Grande do Norte (UFRN), Santa Cruz, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Scattone Silva', 'Affiliation': 'Postgraduate Program in Rehabilitation Sciences, Faculty of Health Sciences of Trairi, Federal University of Rio Grande do Norte (UFRN), Santa Cruz, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Bruno T', 'Initials': 'BT', 'LastName': 'Saragiotto', 'Affiliation': 'Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo (UNICID), São Paulo, Brazil.'}, {'ForeName': 'Jaine Maria Pontes', 'Initials': 'JMP', 'LastName': 'Oliveira', 'Affiliation': 'Faculty of Health Sciences of Trairi, Federal University of Rio Grande do Norte (UFRN), Santa Cruz, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Yago Tavares', 'Initials': 'YT', 'LastName': 'Pinheiro', 'Affiliation': 'Postgraduate Program in Rehabilitation Sciences, Faculty of Health Sciences of Trairi, Federal University of Rio Grande do Norte (UFRN), Santa Cruz, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Caio Alano Almeida', 'Initials': 'CAA', 'LastName': 'Lins', 'Affiliation': 'Postgraduate Program in Rehabilitation Sciences, Faculty of Health Sciences of Trairi, Federal University of Rio Grande do Norte (UFRN), Santa Cruz, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Marcelo Cardoso', 'Initials': 'MC', 'LastName': 'de Souza', 'Affiliation': 'Postgraduate Program in Rehabilitation Sciences, Faculty of Health Sciences of Trairi, Federal University of Rio Grande do Norte (UFRN), Santa Cruz, Rio Grande do Norte, Brazil. Electronic address: marcelocardoso@facisa.ufrn.br.'}]",Journal of physiotherapy,['10.1016/j.jphys.2021.02.013'] 2660,33762075,"A partially randomised trial of pretomanid, moxifloxacin and pyrazinamide for pulmonary TB.","BACKGROUND: Treatment for TB is lengthy and toxic, and new regimens are needed. METHODS: Participants with pulmonary drug-susceptible TB (DS-TB) were randomised to receive: 200 mg pretomanid (Pa, PMD) daily, 400 mg moxifloxacin (M) and 1500 mg pyrazinamide (Z) for 6 months (6Pa 200 MZ) or 4 months (4Pa 200 MZ); 100 mg pretomanid daily for 4 months in the same combination (4Pa 100 MZ); or standard DS-TB treatment for 6 months. The primary outcome was treatment failure or relapse at 12 months post-randomisation. The non-inferiority margin for between-group differences was 12.0%. Recruitment was paused following three deaths and not resumed. RESULTS: Respectively 4/47 (8.5%), 11/57 (19.3%), 14/52 (26.9%) and 1/53 (1.9%) DS-TB outcomes were unfavourable in patients on 6Pa 200 MZ, 4Pa 200 MZ, 4Pa 100 MZ and controls. There was a 6.6% (95% CI -2.2% to 15.4%) difference per protocol and 9.9% (95%CI -4.1% to 23.9%) modified intention-to-treat difference in unfavourable responses between the control and 6Pa 200 MZ arms. Grade 3+ adverse events affected 68/203 (33.5%) receiving experimental regimens, and 19/68 (27.9%) on control. Ten of 203 (4.9%) participants on experimental arms and 2/68 (2.9%) controls died. CONCLUSION: PaMZ regimens did not achieve non-inferiority in this under-powered trial. An ongoing evaluation of PMD remains a priority.",2021,"DS-TB outcomes were unfavourable in patients on 6Pa 200 MZ, 4Pa 200 MZ, 4Pa 100 MZ and controls.","['Participants with pulmonary drug-susceptible TB (DS-TB', 'pulmonary TB']","['standard DS-TB treatment', ' 200 mg pretomanid (Pa, PMD) daily, 400 mg moxifloxacin (M) and 1500 mg pyrazinamide (Z', 'PaMZ', 'pretomanid, moxifloxacin and pyrazinamide']","['Grade 3+ adverse events', 'treatment failure or relapse', 'DS-TB outcomes']","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0231204', 'cui_str': 'Susceptible'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205711', 'cui_str': 'Pelizaeus-Merzbacher disease'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0034239', 'cui_str': 'Pyrazinamide'}]","[{'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.412956,"DS-TB outcomes were unfavourable in patients on 6Pa 200 MZ, 4Pa 200 MZ, 4Pa 100 MZ and controls.","[{'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Tweed', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London (UCL), London, UK.'}, {'ForeName': 'G H', 'Initials': 'GH', 'LastName': 'Wills', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London (UCL), London, UK.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Crook', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London (UCL), London, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Amukoye', 'Affiliation': 'Centre for Respiratory Disease Research, Kenya Medical Research Institute (KEMRI), Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Balanag', 'Affiliation': 'Lung Center of the Philippines, National Centre for Pulmonary Research, Quezon City, The Philippines.'}, {'ForeName': 'A Y L', 'Initials': 'AYL', 'LastName': 'Ban', 'Affiliation': 'Pusat Perubatan Universiti Kebangsaan, Kuala Lumpur, Malaysia.'}, {'ForeName': 'A L C', 'Initials': 'ALC', 'LastName': 'Bateson', 'Affiliation': 'Centre for Clinical Microbiology, UCL, London, UK.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Betteridge', 'Affiliation': 'Global Alliance for TB Drug Development, New York, NY, USA.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Brumskine', 'Affiliation': 'Aurum Institute, Rustenburg, South Africa.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Caoili', 'Affiliation': 'Tropical Disease Foundation, Makati Medical Centre, Makati City, Phillippines.'}, {'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'Chaisson', 'Affiliation': 'School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cevik', 'Affiliation': 'Medical School, University of St Andrews, St Andrews, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Conradie', 'Affiliation': 'University of the Witwatersrand, Clinical HIV Research Unit, Johannesburg.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Dawson', 'Affiliation': 'University of Cape Town Lung Institute, Cape Town.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Del Parigi', 'Affiliation': 'Global Alliance for TB Drug Development, New York, NY, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Diacon', 'Affiliation': 'TASK Applied Science, Bellville, South Africa & Division of Physiology, Department of Medical Biochemistry, University of Stellenbosch, Tygerberg, South Africa.'}, {'ForeName': 'D E', 'Initials': 'DE', 'LastName': 'Everitt', 'Affiliation': 'Global Alliance for TB Drug Development, New York, NY, USA.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Fabiane', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London (UCL), London, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hunt', 'Affiliation': 'Centre for Clinical Microbiology, UCL, London, UK.'}, {'ForeName': 'A I', 'Initials': 'AI', 'LastName': 'Ismail', 'Affiliation': 'Universiti Teknologi MARA, Selangor, Malaysia.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Lalloo', 'Affiliation': 'Enhancing Care Foundation, Durban International Clinical Research Site, Wentworth Hospital, Durban.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Lombard', 'Affiliation': 'Global Alliance for TB Drug Development, New York, NY, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Louw', 'Affiliation': 'Madibeng Centre for Research, Brits, & Department of Family Medicine, University of Pretoria, Pretoria.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Malahleha', 'Affiliation': 'Setshaba Research Centre, Soshanguve, South Africa.'}, {'ForeName': 'T D', 'Initials': 'TD', 'LastName': 'McHugh', 'Affiliation': 'Centre for Clinical Microbiology, UCL, London, UK.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Mendel', 'Affiliation': 'Global Alliance for TB Drug Development, New York, NY, USA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Mhimbira', 'Affiliation': 'Ifakara Health Institute (IHI), Dar es Salaam, Tanzania.'}, {'ForeName': 'R N', 'Initials': 'RN', 'LastName': 'Moodliar', 'Affiliation': 'THINK (Tuberculosis and HIV Investigative Network), Durban, South Africa.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Nduba', 'Affiliation': 'KEMRI, Nairobi, Kenya.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Nunn', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London (UCL), London, UK.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Sabi', 'Affiliation': 'Mbeya Medical Research Center, National Institute for Medical Research, Mbeya, Tanzania.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Sebe', 'Affiliation': 'The Aurum Institute, Tembisa Clinical Research Centre, Tembisa.'}, {'ForeName': 'R A P', 'Initials': 'RAP', 'LastName': 'Selepe', 'Affiliation': 'The Aurum Institute, Klerksdorp, South Africa.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Staples', 'Affiliation': 'THINK (Tuberculosis and HIV Investigative Network), Durban, South Africa.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Swindells', 'Affiliation': 'Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'van Niekerk', 'Affiliation': 'Global Alliance for TB Drug Development, Pretoria.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Variava', 'Affiliation': 'Klerksdorp Tshepong Hospital, Klerksdorp, South Africa.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Spigelman', 'Affiliation': 'Global Alliance for TB Drug Development, New York, NY, USA.'}, {'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Gillespie', 'Affiliation': 'Medical School, University of St Andrews, St Andrews, UK.'}]",The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease,['10.5588/ijtld.20.0513'] 2661,33762023,Collaborative chronic care model implementation within outpatient behavioral health care teams: qualitative results from a multisite trial using implementation facilitation.,"BACKGROUND This paper reports on a qualitative evaluation of a hybrid type II stepped-wedge, cluster randomized trial using implementation facilitation to implement team-based care in the form of the collaborative chronic care model (CCM) in interdisciplinary outpatient mental health teams. The objective of this analysis is to compare the alignment of sites' clinical processes with the CCM elements at baseline (time 1) and after 12 months of implementation facilitation (time 2) from the perspective of providers. METHODS We conducted semi-structured interviews to assess the extent to which six CCM elements were in place: work role redesign, patient self-management support, provider decision support, clinical information systems, linkages to community resources, and organizational/leadership support. Interviews were transcribed and a priori CCM elements were coded using a directed content analysis approach at times 1 and 2. We sought consensus on, and compared, the extent to which each CCM element was in place at times 1 and 2. RESULTS We conducted 27 and 31 telephone interviews at times 1 and 2, respectively, with outpatient mental health providers at nine participating sites. At time 1 and time 2, three CCM elements were most frequently present across the sites: work role redesign, patient self-management support, and provider decision support. The CCM elements with increased implementation from time 1 to time 2 were work role redesign, patient self-management support, and clinical information systems. For two CCM elements, linkages to community resources and organizational/leadership support, some sites had increased implementation at time 2 compared to time 1, while others had reductions. For the provider decision support element, we saw little change in the extent of its implementation. CONCLUSIONS Sites increased the extent of implementation on several CCM elements. The most progress was made in the CCM elements where sites had CCM-aligned processes in place at time 1. Teams made progress on elements they could more easily control, such as work role redesign. Our results suggest that maximizing the benefits of CCM-based outpatient mental health care may require targeting resources and training toward specific CCM elements-especially in the use of clinical information systems and linking with community resources. TRIAL REGISTRATION Clinical Trials NCT02543840 .",2021,"The CCM elements with increased implementation from time 1 to time 2 were work role redesign, patient self-management support, and clinical information systems.","['27 and 31 telephone interviews at times 1 and 2, respectively, with outpatient mental health providers at nine participating sites', 'outpatient behavioral health care teams']",[],[],"[{'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}]",[],[],,0.0460867,"The CCM elements with increased implementation from time 1 to time 2 were work role redesign, patient self-management support, and clinical information systems.","[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Sullivan', 'Affiliation': 'Center for Healthcare Organization and Implementation Research, VA Boston Healthcare System, 150 S. Huntington Ave (152M), Boston, MA, USA. Jennifer.sullivan@va.gov.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Kim', 'Affiliation': 'Center for Healthcare Organization and Implementation Research, VA Boston Healthcare System, 150 S. Huntington Ave (152M), Boston, MA, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Miller', 'Affiliation': 'Center for Healthcare Organization and Implementation Research, VA Boston Healthcare System, 150 S. Huntington Ave (152M), Boston, MA, USA.'}, {'ForeName': 'A Rani', 'Initials': 'AR', 'LastName': 'Elwy', 'Affiliation': 'Center for Healthcare Organization and Implementation Research, VA Bedford Healthcare System, 200 Springs Road (152), Bedford, MA, USA.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Drummond', 'Affiliation': 'Center for Mental Healthcare and Outcomes Research, Central Arkansas Veterans Healthcare System, North Little Rock, AR, USA.'}, {'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Connolly', 'Affiliation': 'Center for Healthcare Organization and Implementation Research, VA Boston Healthcare System, 150 S. Huntington Ave (152M), Boston, MA, USA.'}, {'ForeName': 'Rachel P', 'Initials': 'RP', 'LastName': 'Riendeau', 'Affiliation': 'Center for Healthcare Organization and Implementation Research, VA Boston Healthcare System, 150 S. Huntington Ave (152M), Boston, MA, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Bauer', 'Affiliation': 'Center for Healthcare Organization and Implementation Research, VA Boston Healthcare System, 150 S. Huntington Ave (152M), Boston, MA, USA.'}]",Implementation science communications,['10.1186/s43058-021-00133-w'] 2662,33760671,The Effect of Photobiomodulation on Analgesia During Childbirth: A Controlled and Randomized Clinical Trial.,"Background: Pain during labor can be a barrier when choosing vaginal delivery. In an attempt to relief pain during labor, several pharmacological and nonpharmacological methods are proposed. Objective: To assess the effect of light-emitting diode (LED) photobiomodulation on analgesia during labor. Methods: A clinical trial was conducted with 29 women who were divided into two groups: G1 (experimental group-LED) and G2 (control group-hot shower). In the experimental group, an LED plate with red and infrared merged [red 660 ± 20 nm, 5 mW/cm 2 , 3 J per LED (108 J) and infrared 850 ± 20 nm, 5 mW/cm 2 , 3 J per LED (108 J), total energy = 216 J] was placed on the subjects' dorsal region, at the level of T10 to S4, for 10 min, with the plate automatically turning off. Hot shower at controlled temperature was offered for 30 min. To verify the effect of LED on analgesia during labor, the following variables were assessed: (1) perception of pain, (2) fetal well-being assessed by cardiotocography or intermittent auscultation of fetal heart rate, (3) Apgar score at minutes 1 and 5 after birth, and (4) labor duration. Results: There was a statistically significant difference ( p  < 0.05) in pain reduction evidenced by a millimetric visual scale, before and after application on G1-LED (7.92 ± 1.78). Regarding the other variables, there was no statistical difference between the groups when comparing fetal well-being, Apgar score and labor duration. Conclusions: It is concluded that LED can be considered an alternative, since it caused pain reduction without changing other parameters during labor, compared with hot shower, a method included in hospital protocols, proving to be safe. Clinical Trial Registration number: NCT03496857.",2021,"There was a statistically significant difference ( p  < 0.05) in pain reduction evidenced by a millimetric visual scale, before and after application on G1-LED (7.92 ± 1.78).","['Analgesia During Childbirth', '29 women who were divided into two groups']","['G1 (experimental group-LED) and G2 (control group-hot shower', 'LED plate with red and infrared merged [red 660\u2009±\u200920\u2009nm, 5', 'Photobiomodulation', 'light-emitting diode (LED) photobiomodulation', 'LED']","['Pain', 'millimetric visual scale', 'fetal well-being, Apgar score and labor duration', 'perception of pain, (2) fetal well-being assessed by cardiotocography or intermittent auscultation of fetal heart rate, (3) Apgar score at minutes 1 and 5 after birth, and (4) labor duration', 'pain reduction']","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0541748', 'cui_str': 'Shower'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C1532326', 'cui_str': 'Infra-red'}, {'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0162676', 'cui_str': 'Enzyme-multiplied immunoassay technique'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0566679', 'cui_str': 'Duration of labor'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0007208', 'cui_str': 'CTG, Antepartum'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0018811', 'cui_str': 'Fetal heart rate'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",29.0,0.117273,"There was a statistically significant difference ( p  < 0.05) in pain reduction evidenced by a millimetric visual scale, before and after application on G1-LED (7.92 ± 1.78).","[{'ForeName': 'Maria Aparecida', 'Initials': 'MA', 'LastName': 'Traverzim', 'Affiliation': 'Biophotonics Applied to Health Sciences, and University Nove de Julho, São Paulo, Brazil.'}, {'ForeName': 'Ana Paula Taboada', 'Initials': 'APT', 'LastName': 'Sobral', 'Affiliation': 'Biophotonics Applied to Health Sciences, and University Nove de Julho, São Paulo, Brazil.'}, {'ForeName': 'Kristianne Porta Santos', 'Initials': 'KPS', 'LastName': 'Fernandes', 'Affiliation': 'Biophotonics Applied to Health Sciences, and University Nove de Julho, São Paulo, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'de Fátima Teixeira Silva', 'Affiliation': 'Biophotonics Applied to Health Sciences, and University Nove de Julho, São Paulo, Brazil.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Pavani', 'Affiliation': 'Biophotonics Applied to Health Sciences, and University Nove de Julho, São Paulo, Brazil.'}, {'ForeName': 'Raquel Agnelli', 'Initials': 'RA', 'LastName': 'Mesquita-Ferrari', 'Affiliation': 'Biophotonics Applied to Health Sciences, and University Nove de Julho, São Paulo, Brazil.'}, {'ForeName': 'Anna Carolina Ratto Tempestini', 'Initials': 'ACRT', 'LastName': 'Horliana', 'Affiliation': 'Biophotonics Applied to Health Sciences, and University Nove de Julho, São Paulo, Brazil.'}, {'ForeName': 'Andréa Oliver', 'Initials': 'AO', 'LastName': 'Gomes', 'Affiliation': 'Post Graduation Program in Rehabilitation Sciences, University Nove de Julho, São Paulo, Brazil.'}, {'ForeName': 'Sandra Kalil', 'Initials': 'SK', 'LastName': 'Bussadori', 'Affiliation': 'Biophotonics Applied to Health Sciences, and University Nove de Julho, São Paulo, Brazil.'}, {'ForeName': 'Lara Jansiski', 'Initials': 'LJ', 'LastName': 'Motta', 'Affiliation': 'Biophotonics Applied to Health Sciences, and University Nove de Julho, São Paulo, Brazil.'}]","Photobiomodulation, photomedicine, and laser surgery",['10.1089/photob.2020.4976'] 2663,33767795,Comparison of the effectiveness of Satureja khuzestanica and clotrimazole vaginal creams for the treatment of vulvovaginal candidiasis.,"Candidal vaginitis has a relatively high prevalence, and its resistance to treatment is on the rise. Considering the complications of chemical drugs, the use of herbal medicines has now been favored due to the lack of changes in the normal vaginal flora. The aim of this study was to compare the effectiveness of Satureja khuzestanica and clotrimazole vaginal creams for the treatment of candidal vulvovaginitis. A randomized clinical trial was conducted on 84 reproductive-aged women in the city of Ahvaz, Iran. Individuals were randomly divided into two treatment groups: 1% Satureja khuzestanica vaginal creams (n=42) and 1% clotrimazole vaginal cream (n=42) who used a one-full applicator daily for one week. About 4-7 days after the end of treatment, a clinical examination and laboratory re-tests were performed to determine the level of treatment. The data were analyzed using the Mann-Whitney U, t-test and Chi-square tests, with SPSS version 22. After the treatment, no significant difference was observed between the two groups in terms of vaginal discharge (p = 0.32), vaginal itching (p = 0.26), dysuria (p = 0.99) and dyspareunia (p = 0.60). Moreover, the results of culture (p = 0.62) and smear (p = 0.58) were not statistically significant in the two groups. Also, there was no significant difference between the two groups in terms of complete recovery after the treatment (p = 0.35). Satureja khuzestanica seems to have the same effect as clotrimazole in improving the symptoms of vaginal candidiasis, the negative results of culture and smear, as well as complete treatment.",2021,"Moreover, the results of culture (p = 0.62) and smear (p = 0.58) were not statistically significant in the two groups.","['84 reproductive-aged women in the city of Ahvaz, Iran', 'candidal vulvovaginitis', 'vulvovaginal candidiasis']","['Satureja khuzestanica vaginal creams (n=42) and 1% clotrimazole vaginal cream (n=42) who used a one-full applicator daily for one week', 'clotrimazole', 'clotrimazole vaginal creams', 'Satureja khuzestanica and clotrimazole vaginal creams']","['dyspareunia', 'complete recovery', 'dysuria', 'vaginal discharge', 'vaginal itching']","[{'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0700345', 'cui_str': 'Candidal vulvovaginitis'}]","[{'cui': 'C1015032', 'cui_str': 'Savory Plant'}, {'cui': 'C0042238', 'cui_str': 'Vaginal cream'}, {'cui': 'C1251895', 'cui_str': 'Clotrimazole Vaginal Cream'}, {'cui': 'C0179108', 'cui_str': 'Applicator'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0009074', 'cui_str': 'Clotrimazole'}]","[{'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013428', 'cui_str': 'Dysuria'}, {'cui': 'C0227791', 'cui_str': 'Vaginal discharge'}, {'cui': 'C0042256', 'cui_str': 'Pruritus of vagina'}]",84.0,0.013117,"Moreover, the results of culture (p = 0.62) and smear (p = 0.58) were not statistically significant in the two groups.","[{'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Jaldani', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Fatahinia', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Health Research Institute, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Maraghi', 'Affiliation': 'Department of Medical Mycology, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Eskandar', 'Initials': 'E', 'LastName': 'Moghimipour', 'Affiliation': 'Medicinal Plant Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Javadnoori', 'Affiliation': 'Department of Biostatistics and Epidemiology, Faculty of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",Journal of medicine and life,['10.25122/jml-2020-0014'] 2664,33767791,The effect of ketamine on preventing postpartum depression.,"Postpartum depression is a common disabling psychosocial disorder that could have adverse effects on the life of the mother, infant, and family. The present study was conducted to evaluate the effect of ketamine on preventing postpartum depression in women undergoing caesarian sections considering the relatively known positive effect of ketamine on major depression. The present double-blind, randomized clinical trial was conducted on 134 women undergoing scheduled caesarian sections. Participants were randomly allocated into two groups of control and intervention. To induce anesthesia, 1-2 mg/kg of body weight of Nesdonal and 0.5 mg/kg of body weight of ketamine were used in the intervention group, while only 3-5 mg/kg of body weight Nesdonal was administered in the control group. Data were gathered using the Edinburgh Postnatal Depression Scale (EPDS) in three stages: before the caesarian section and two and four weeks after the caesarian section. Data were analyzed using variance analysis with repeated measures and the Chi-square test. Results of the present study showed that the mean (± standard deviation) of the depression score in the intervention and control groups were 13.78±3.87 and 13.79±4.78(p = 0.98) before the caesarian section, 11.82±3.41 and 14.34±4.29 (p < 0.001) two weeks after and 10.84±3.48 and 13.09±3.79 (p = 0.001) four weeks after the caesarian section, respectively. Using ketamine in the induction of general anesthesia could be effective in preventing postpartum depression. However, further studies are required to strengthen these findings.",2021,"Results of the present study showed that the mean (± standard deviation) of the depression score in the intervention and control groups were 13.78±3.87 and 13.79±4.78(p = 0.98) before the caesarian section, 11.82±3.41 and 14.34±4.29 (p < 0.001) two weeks after and 10.84±3.48 and 13.09±3.79 (p = 0.001) four weeks after the caesarian section, respectively.","['women undergoing caesarian sections', '134 women undergoing scheduled caesarian sections']",['ketamine'],"['Edinburgh Postnatal Depression Scale (EPDS', 'mean (± standard deviation) of the depression score', 'postpartum depression']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}]",134.0,0.0868006,"Results of the present study showed that the mean (± standard deviation) of the depression score in the intervention and control groups were 13.78±3.87 and 13.79±4.78(p = 0.98) before the caesarian section, 11.82±3.41 and 14.34±4.29 (p < 0.001) two weeks after and 10.84±3.48 and 13.09±3.79 (p = 0.001) four weeks after the caesarian section, respectively.","[{'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Alipoor', 'Affiliation': 'Department of Anesthesiology, School of Paramedical Sciences, Rafsanjan University of Medical Sciences, Rafsanjan, Iran.'}, {'ForeName': 'Marzeyeh', 'Initials': 'M', 'LastName': 'Loripoor', 'Affiliation': 'Department of Reproductive Health and Midwifery, School of Nursing and Midwifery; Geriatric Care Research Center, Rafsanjan University of Medical Sciences, Rafsanjan, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Kazemi', 'Affiliation': 'Department of Medical Surgical Nursing, Faculty of Nursing and Midwifery, Non-Communicable Disease Research Center, Rafsanjan University of Medical Sciences, Rafsanjan, Iran.'}, {'ForeName': 'Farshid', 'Initials': 'F', 'LastName': 'Farahbakhsh', 'Affiliation': 'Department of Anesthesiology, School of Medicine, Rafsanjan University of Medical Sciences, Rafsanjan, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Sarkoohi', 'Affiliation': 'Department of Anesthesiology, School of Medicine, Rafsanjan University of Medical Sciences, Rafsanjan, Iran.'}]",Journal of medicine and life,['10.25122/jml-2020-0116'] 2665,33767787,Comparative analysis of flexural strength of abraded and polished porcelain surfaces - an in vitro study.,"Typically, prosthodontists adjust ceramic restorations glazed surface by grinding prior to insertion. Such alterations of surfaces are necessary for the correction of occlusal interferences. We aimed to evaluate and compare the change in flexural strength of ceramic surfaces after re-glazing and polishing. This study included 40 samples of ceramic blocks that were fabricated and glazed, and then fired in accordance with the manufacturer's recommendations. The sample was randomly divided into four groups of 10 samples each. The first group was the control group with unaltered glazed samples. The second group was abraded with an extra-fine diamond bur followed by re-glazing, and the other two groups were polished with two commercially available polishing kits after abrading them with an extra-fine diamond bur. The samples were tested for their flexural strength using a universal testing machine. On the application of the F test on the means of all the groups, a value greater than 0.05 was found, which meant that there is no statistically significant difference in flexural strength values between the groups (P-value>0.05). Since the flexural strength values of the polished group were comparable to the other groups, polishing can be used instead of re-glazing for ceramic restorations. This reduces an additional clinical appointment for the patient and saves working time.",2021,"Since the flexural strength values of the polished group were comparable to the other groups, polishing can be used instead of re-glazing for ceramic restorations.","[""40 samples of ceramic blocks that were fabricated and glazed, and then fired in accordance with the manufacturer's recommendations""]",[],['flexural strength values'],"[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0014007', 'cui_str': 'Dismissed from job'}]",[],"[{'cui': 'C4704755', 'cui_str': 'Fracture Strength'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0180673,"Since the flexural strength values of the polished group were comparable to the other groups, polishing can be used instead of re-glazing for ceramic restorations.","[{'ForeName': 'Prathibha', 'Initials': 'P', 'LastName': 'Nandagiri', 'Affiliation': 'Sparkles Dental Clinic, Lalapet, Secunderabad, Hyderabad, Telangana, India.'}, {'ForeName': 'Mamidi', 'Initials': 'M', 'LastName': 'Praveen', 'Affiliation': 'Department of Prosthodontics, Panineeya Institute of Dental Sciences, Hyderabad, Telangana, India.'}, {'ForeName': 'Shikha', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': ""Department of Conservative Dentistry and Endodontics, People's Dental College of Dental Sciences and Research Center, Bhopal, India.""}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Singh', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Modern Dental College and Research Center, Indore, India.'}, {'ForeName': 'Namratha', 'Initials': 'N', 'LastName': 'Chandrahari', 'Affiliation': 'Clove Dental Hospital, Hyderabad Telangana, India.'}, {'ForeName': 'Fayez Hussain', 'Initials': 'FH', 'LastName': 'Niazi', 'Affiliation': 'Department of Restorative and Prosthetics Dental Sciences, College of Dentistry, Dar Al Uloom University, Riyadh, Saudi Arabia.'}]",Journal of medicine and life,['10.25122/jml-2020-0085'] 2666,33766685,Nasogastric tube insertion using conventional versus bubble technique for its confirmation in anesthetized patients: a prospective randomized study.,"BACKGROUND Nasogastric tube insertion and confirmation of its position can be difficult in the anesthetized patient. The purpose of the present study was to compare the bubble technique with the conventional method for confirmation of nasogastric tube placement in these patients. METHODS Two hundred sixty adult patients, aged between 20-70 years, posted for surgeries requiring general anesthesia, tracheal intubation, and a nasogastric tube were enrolled in this study. Patients were randomized into 2 groups: Group B (Bubble group) and Group C (Control group). In Group C, a conventional technique using a lubricated nasogastric tube was positioned through the nostril with head remained neutral. In Group B, 2% lidocaine jelly was added to the proximal end to form a single bubble. The correct placement of the nasogastric tube in the stomach was confirmed by fluoroscopy by an independent observer intraoperatively. RESULTS The duration of nasogastric tube insertion was 57.2±13.3seconds in Group B and 59.8±11.9seconds in Group C (p=0.111). The confirmation rate of the bubble technique was 76.8% (95% CI: 68.7-83.3), which was significantly better than the conventional method where the confirmation rate was 59.7% (95% CI 50.9-67.9), p<0.001. When compared to fluoroscopy, bubble technique was found to have a sensitivity of 92.3% (95% CI: 85.6-96.1) with specificity of 81.0% (95% CI: 60.0-92.3), positive predictive value of 96.0% (95% CI: 90.2-98.4), and a moderate negative predictive value of 68.0% (95% CI: 48.4-82.8). CONCLUSIONS The bubble technique of nasogastric tube insertion has a higher confirmation rate in comparison to the conventional technique. TRIAL REGISTRY NUMBER Clinical Trial Registry of India (CTRI/2018/09/015864).",2021,"When compared to fluoroscopy, bubble technique was found to have a sensitivity of 92.3% (95% CI: 85.6-96.1) with specificity of 81.0% (95% CI: 60.0-92.3), positive predictive value of 96.0% (95% CI: 90.2-98.4) and a moderate negative predictive value of 68.0% (95% CI: 48.4-82.8). ","['anesthetized patients', 'Two hundred sixty adult patients, aged between 20-70 years posted for surgeries requiring general anesthesia, tracheal intubation, and a nasogastric tube were enrolled in this study']","['Nasogastric tube insertion using conventional versus bubble technique', 'nasogastric tube placement', 'nasogastric tube insertion', 'lidocaine']","['confirmation rate', 'duration of nasogastric tube insertion', 'confirmation rate of the bubble technique', 'positive predictive value']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0085678', 'cui_str': 'Nasogastric tube'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0204819', 'cui_str': 'Insertion of nasogastric tube'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0085678', 'cui_str': 'Nasogastric tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0521091', 'cui_str': 'Confirmation of'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0204819', 'cui_str': 'Insertion of nasogastric tube'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",260.0,0.0598978,"When compared to fluoroscopy, bubble technique was found to have a sensitivity of 92.3% (95% CI: 85.6-96.1) with specificity of 81.0% (95% CI: 60.0-92.3), positive predictive value of 96.0% (95% CI: 90.2-98.4) and a moderate negative predictive value of 68.0% (95% CI: 48.4-82.8). ","[{'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'All India Institute of Medical Sciences (AIIMS), Department of Trauma & Emergency (Anaesthesiology), Jodhpur, India. Electronic address: ankuranaesthesia@gmail.com.'}, {'ForeName': 'Varuna', 'Initials': 'V', 'LastName': 'Vyas', 'Affiliation': 'All India Institute of Medical Sciences (AIIMS), Department of Pediatrics, Jodhpur, India.'}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Goyal', 'Affiliation': 'All India Institute of Medical Sciences (AIIMS), Department of Anaesthesiology & Critical Care, Jodhpur, India.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Bhatia', 'Affiliation': 'All India Institute of Medical Sciences (AIIMS), Department of Anaesthesiology & Critical Care, Jodhpur, India.'}, {'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Sethi', 'Affiliation': 'All India Institute of Medical Sciences (AIIMS), Department of Anaesthesiology & Critical Care, Jodhpur, India.'}, {'ForeName': 'Akhil Dhanesh', 'Initials': 'AD', 'LastName': 'Goel', 'Affiliation': 'All India Institute of Medical Sciences (AIIMS), Department of Community & Family Medicine, Jodhpur, India.'}]",Brazilian journal of anesthesiology (Elsevier),['10.1016/j.bjane.2021.01.011'] 2667,33766681,"Effect of ondansetron on spinal anesthesia-induced hypotension in non-obstetric surgeries: a randomised, double-blind and placebo-controlled trial.","BACKGROUND AND OBJECTIVES Spinal anesthesia is an effective technique for many surgical procedures, but it is often associated with an increased risk of potentially deleterious hemodynamic disturbances. The benefits of prophylactic ondansetron for preventing spinal anesthesia-induced hypotension are still uncertain. Therefore, this study aimed to compare the effect of ondansetron and placebo before spinal block on the incidence of hypotension in patients having non-obstetric surgeries. METHODS Randomized, double-blind, parallel-group, superiority trial with a 1:1 allocation ratio. A total of 144 patients scheduled for non-obstetric surgeries with an indication for spinal anesthesia were randomized. Patients received intravenous ondansetron (8mg) or placebo before standard spinal anesthesia. The primary outcome was the rate of hypotension in the first 30 minutes after spinal anesthesia. RESULTS Hypotension occurred in 20 of 72 patients (27.8%) in the ondansetron group and in 36 of 72 patients (50%) in the placebo group (Odds Ratio-OR=0.38; 95% Confidence Interval-CI 0.19 to 0.77; p=0.007). Fewer patients in the ondansetron group required ephedrine compared to the placebo group (13.9% vs. 27.8%; OR=0.42; 95% CI 0.18 to 0.98; p=0.04). Exploratory analyses revealed that ondansetron may be more effective than placebo in patients aged 60 years or older (OR=0.12; 95% CI 0.03 to 0.48; p=0.03). No difference in heart rate variations was observed. CONCLUSION Our findings suggest that ondansetron can be a viable and effective strategy to reduce both the incidence of spinal anesthesia-induced hypotension and vasopressors usage in non-obstetric surgeries.",2021,Fewer patients in the ondansetron group required ephedrine compared to the placebo group (13.9% vs. 27.8%; OR=0.42; 95% CI 0.18 to 0.98; p=0.04).,"['144 patients scheduled for non-obstetric surgeries with an indication for spinal anesthesia', 'non-obstetric surgeries', 'patients having non-obstetric surgeries']","['ephedrine', 'ondansetron and placebo', 'prophylactic ondansetron', 'ondansetron', 'placebo', 'intravenous ondansetron']","['spinal anesthesia-induced hypotension', 'incidence of hypotension', 'heart rate variations', 'Hypotension', 'rate of hypotension in the first 30-minutes after spinal anesthesia']","[{'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0038906', 'cui_str': 'Obstetric operation'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]","[{'cui': 'C0014479', 'cui_str': 'Ephedrine'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0456693', 'cui_str': '/30 min'}]",144.0,0.779431,Fewer patients in the ondansetron group required ephedrine compared to the placebo group (13.9% vs. 27.8%; OR=0.42; 95% CI 0.18 to 0.98; p=0.04).,"[{'ForeName': 'Fabrício Tavares', 'Initials': 'FT', 'LastName': 'Mendonça', 'Affiliation': 'Hospital de Base do Distrito Federal, Departamento de Anestesiologia, Brasília, DF, Brazil. Electronic address: fabricio.tavares@me.com.'}, {'ForeName': 'Luis Carlos', 'Initials': 'LC', 'LastName': 'Crepaldi Junior', 'Affiliation': 'Hospital de Base do Distrito Federal, Departamento de Anestesiologia, Brasília, DF, Brazil.'}, {'ForeName': 'Rafaela Carvalho', 'Initials': 'RC', 'LastName': 'Gersanti', 'Affiliation': 'Hospital de Base do Distrito Federal, Departamento de Anestesiologia, Brasília, DF, Brazil.'}, {'ForeName': 'Kamila Christine', 'Initials': 'KC', 'LastName': 'de Araújo', 'Affiliation': 'Hospital de Base do Distrito Federal, Departamento de Anestesiologia, Brasília, DF, Brazil.'}]",Brazilian journal of anesthesiology (Elsevier),['10.1016/j.bjane.2020.12.028'] 2668,33766513,Effects of different surface treatments and adhesive self-etch functional monomers on the repair of bulk fill composites: A randomised controlled study.,"OBJECTIVE To evaluate the effect of different adhesive protocols on the microtensile bond strength (μTBS) and integrity of the repaired bulk fill composite interface. METHODS Two hundred and seventy composite blocks made of bulk fill composites of different viscosity were randomly assigned to 18 surface conditioning groups (n = 15/group). The universal adhesive systems used were Heliobond™, Tokuyama bond force II™ and Scotchbond Universal™. A nanohybrid resin composite was applied as the repair material. Negative and positive control groups were included. Stick shape specimens of each group were subjected to μTBS testing. Representative samples from all test groups were subjected to microscopic, profilometric and SEM examination to determine their mode of failure. The data were analysed statistically using two-way ANOVA test, Tukey's test and the independent t-test (α = 0.05). RESULTS The mean μTBS of all test groups ranged between 28.5 and 46.8 MPa and varied with the type of adhesive system employed. Significantly highest μTBS values were obtained when Tokuyama bond force II™ and Scotchbond Universal™ adhesives were used (p < 0.01) which were comparable to the coherent strength of the bulk fill resin composite in the positive control groups (p > 0.05). The viscosity of the bulk fill composite did not significantly influence repair bond strength. The microscopy and SEM examination of the failed interfaces revealed a mixture of adhesive and cohesive failures. CONCLUSIONS Under the tested conditions, significantly greater μTBS of repaired bulk fill composite was achieved when the substrate surface was treated with adhesive systems containing a functional monomer. CLINICAL SIGNIFICANCE Eff ;ecting a repair of a bulk fill resin composite restoration with the application of a functional monomer containing adhesive system, such as Tokuyama Bond Force II™ or Scotchbond Universal™, would seem to enhance the interfacial bond strength and integrity of the repaired resin composite interface.",2021,Significantly highest μTBS values were obtained when Tokuyama bond force II TM and Scotchbond Universal TM adhesives were used (p < 0.01) which were comparable to the coherent strength of the bulk fill resin composite in the positive control groups (p > 0.05).,['Two hundred and seventy composite blocks made of bulk fill composites of different viscosity'],['adhesive self-etch functional monomers'],"['repair bond strength', 'mean μTBS', 'μTBS values', 'microtensile bond strength (μTBS) and integrity', 'coherent strength of the bulk fill resin composite']","[{'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}]","[{'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}]",270.0,0.0535798,Significantly highest μTBS values were obtained when Tokuyama bond force II TM and Scotchbond Universal TM adhesives were used (p < 0.01) which were comparable to the coherent strength of the bulk fill resin composite in the positive control groups (p > 0.05).,"[{'ForeName': 'Igor R', 'Initials': 'IR', 'LastName': 'Blum', 'Affiliation': ""Faculty of Dentistry, Oral & Craniofacial Sciences, King's College London, London, United Kingdom. Electronic address: igor.blum@kcl.ac.uk.""}, {'ForeName': 'Renáta', 'Initials': 'R', 'LastName': 'Martos', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dentistry, University of Debrecen, Nagyerdei krt. 98., H4032, Debrecen, Hungary. Electronic address: martos.renata@dental.unideb.hu.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Szalóki', 'Affiliation': 'Department of Biomaterials and Prosthetic Dentistry, Faculty of Dentistry, University of Debrecen, Nagyerdei krt. 98., H4032, Debrecen, Hungary. Electronic address: szaloki.melinda@dental.unideb.hu.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Lynch', 'Affiliation': 'Department of Restorative Dentistry, University Dental School and Hospital, University College Cork, Wilton, Cork Ireland, Ireland. Electronic address: chris.lynch@ucc.ie.'}, {'ForeName': 'Csaba', 'Initials': 'C', 'LastName': 'Hegedűs', 'Affiliation': 'Department of Biomaterials and Prosthetic Dentistry, Faculty of Dentistry, University of Debrecen, Nagyerdei krt. 98., H4032, Debrecen, Hungary. Electronic address: hegedus.csaba.prof@dental.unideb.hu.'}]",Journal of dentistry,['10.1016/j.jdent.2021.103637'] 2669,33775464,Engaging Patients to Ask More Questions: What's the Best Way? A Pragmatic Randomized Controlled Trial.,"PURPOSE Hand conditions are common, and often require a discussion of the tradeoffs of different treatment options. Our goal was to evaluate whether providing patients with a Question Prompt List (QPL) for common hand conditions improves their perceived involvement in care compared with providing patients with 3 generic questions. METHODS We performed a prospective, single-center, pragmatic randomized controlled trial. We created a QPL pamphlet for patients with common hand conditions. New patients with common hand conditions were enrolled between April 2019 and July 2019 and were randomized into either the QPL group (with 35 hand-specific questions) or the AskShareKnow group (3 generic questions: [1] What are my options? [2] What are the possible benefits and harms of those options? [3] How likely are each of these benefit and harms to happen to me?). Both groups received the questions prior to meeting with their surgeon. We used the Perceived Involvement in Care Scale (PICS), a validated instrument designed to evaluate patient participation in decision-making, as our primary outcome. The maximum PICS score is 13, and a higher score indicates higher perceived involvement. RESULTS One hundred twenty-six patients participated in the study, with 63 patients in the QPL group and 63 patients in the AskShareKnow group. The demographic characteristics were similar in the 2 groups. The mean AskShareKnow group PICS score was 8.3 ± 2.2 and the mean QPL PICS score was 7.5 ± 2.8, which was not deemed clinically significant. CONCLUSIONS The QPLs do not increase perceived involvement in care in patients with hand conditions compared with providing patients with 3 generic questions. CLINICAL RELEVANCE Various approaches have been evaluated to help improve patient involvement in their care. In hand surgery, 3 generic questions were no different than a lengthy QPL with respect to patient involvement in their care.",2021,"The QPLs do not increase perceived involvement in care in patients with hand conditions compared with providing patients with 3 generic questions. ","['One hundred twenty-six patients participated in the study, with 63 patients in the QPL group and 63 patients in the AskShareKnow group', 'New patients with common hand conditions were enrolled between April 2019 and July 2019', 'patients with common hand conditions']","['Question Prompt List (QPL', 'AskShareKnow group (3 generic questions: [1] What are my options', 'QPL', 'QPL pamphlet']","['mean AskShareKnow group PICS score', 'maximum PICS score', 'mean QPL PICS score']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0580931', 'cui_str': 'In care'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",126.0,0.106286,"The QPLs do not increase perceived involvement in care in patients with hand conditions compared with providing patients with 3 generic questions. ","[{'ForeName': 'Allison K', 'Initials': 'AK', 'LastName': 'Roe', 'Affiliation': 'Department of Orthopaedic Surgery, VOICES Health Policy Research Center, Stanford University, Redwood City, CA.'}, {'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'Eppler', 'Affiliation': 'Department of Orthopaedic Surgery, VOICES Health Policy Research Center, Stanford University, Redwood City, CA.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Shapiro', 'Affiliation': 'Department of Orthopaedic Surgery, VOICES Health Policy Research Center, Stanford University, Redwood City, CA.'}, {'ForeName': 'Ellen S', 'Initials': 'ES', 'LastName': 'Satteson', 'Affiliation': 'Department of Orthopaedic Surgery, VOICES Health Policy Research Center, Stanford University, Redwood City, CA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': 'Department of Orthopaedic Surgery, VOICES Health Policy Research Center, Stanford University, Redwood City, CA.'}, {'ForeName': 'Robin N', 'Initials': 'RN', 'LastName': 'Kamal', 'Affiliation': 'Department of Orthopaedic Surgery, VOICES Health Policy Research Center, Stanford University, Redwood City, CA. Electronic address: rnkamal@stanford.edu.'}]",The Journal of hand surgery,['10.1016/j.jhsa.2021.02.001'] 2670,33774848,"Insulin resistance in type 1 diabetes managed with metformin (INTIMET): Study protocol of a double-blind placebo-controlled, randomised trial.","BACKGROUND Insulin resistance is an under-recognised metabolic defect and cardiovascular risk factor in Type 1 diabetes. Whether metformin improves hepatic, muscle or adipose tissue insulin sensitivity has not been studied in adults with Type 1 diabetes. We initiated the INTIMET study (INsulin resistance in Type 1 diabetes managed with METformin), a double-blind randomised, placebo-controlled trial to measure the effect of metformin on tissue-specific insulin resistance in adults with Type 1 diabetes. METHODS We will study 40 adults aged 20-55 years with Type 1 diabetes (HbA1c ≤ 80 mmol/mol [9.5%], fasting C-peptide <0.3 nmol/L) and 20 age-, gender- and body mass index (BMI)-matched controls. Insulin sensitivity will be determined by the two-step hyperinsulinaemic-euglycaemic clamp method with deuterated glucose to document liver, muscle and adipose insulin sensitivity. Subjects with Type 1 diabetes will be randomised to metformin extended-release 1500 mg daily or matched placebo for 26 weeks. The primary outcome is change in hepatic insulin sensitivity, assessed by change in basal rate of appearance (Ra) of glucose and suppression of endogenous glucose production (EGP) during the low-dose stage of the clamp. CONCLUSION The INTIMET study is the first clinical trial to quantify the impact of metformin on liver, muscle and adipose insulin resistance in adults with Type 1 diabetes. This study may identify factors that predict an individual's response to metformin in Type 1 diabetes. TRIAL REGISTRATION ACTRN12619001440112.",2021,"We initiated the INTIMET study (INsulin resistance in Type 1 diabetes managed with METformin), a double-blind randomised, placebo-controlled trial to measure the effect of metformin on tissue-specific insulin resistance in adults with Type 1 diabetes. ","['Type 1 diabetes', 'Type 1 Diabetes Managed with', '40 adults aged 20-55 years with Type 1 diabetes (HbA1c ≤ 80mmol/mol [9.5%], fasting C-peptide <0.3nmol/L) and 20 age-, gender- and BMI-matched controls', 'Type 1 diabetes managed with', 'adults with Type 1 diabetes', 'Subjects with Type 1 diabetes']","['METformin', 'metformin extended-release 1500mg daily or matched placebo', 'metformin', 'placebo', 'Metformin']","['tissue-specific insulin resistance', 'hepatic, muscle or adipose tissue insulin sensitivity', 'liver, muscle and adipose insulin resistance', 'Insulin sensitivity', 'Insulin Resistance', 'change in hepatic insulin sensitivity, assessed by change in basal rate of appearance (Ra) of glucose and suppression of endogenous glucose production (EGP']","[{'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0903677', 'cui_str': 'TACSTD1 protein, human'}]",40.0,0.528017,"We initiated the INTIMET study (INsulin resistance in Type 1 diabetes managed with METformin), a double-blind randomised, placebo-controlled trial to measure the effect of metformin on tissue-specific insulin resistance in adults with Type 1 diabetes. ","[{'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Snaith', 'Affiliation': 'Healthy Ageing, Garvan Institute of Medical Research, Darlinghurst, NSW, Australia.'}, {'ForeName': 'Dorit', 'Initials': 'D', 'LastName': 'Samocha-Bonet', 'Affiliation': 'Healthy Ageing, Garvan Institute of Medical Research, Darlinghurst, NSW, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Evans', 'Affiliation': 'Healthy Ageing, Garvan Institute of Medical Research, Darlinghurst, NSW, Australia.'}, {'ForeName': 'Zhixin', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Stats Central, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Kowalski', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, Vic., Australia.'}, {'ForeName': 'Clinton', 'Initials': 'C', 'LastName': 'Bruce', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, Vic., Australia.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Holmes-Walker', 'Affiliation': 'Department of Diabetes and Endocrinology, Westmead Hospital, Westmead, NSW, Australia.'}, {'ForeName': 'Jerry R', 'Initials': 'JR', 'LastName': 'Greenfield', 'Affiliation': 'Healthy Ageing, Garvan Institute of Medical Research, Darlinghurst, NSW, Australia.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14564'] 2671,33774144,A comparison of physical exercise and cognitive training interventions to improve determinants of functional mobility in healthy older adults.,"OBJECTIVES Mobility is a complex but crucial clinical outcome in older adults. Past observational studies have highlighted that cardiorespiratory fitness (CRF), energy cost of walking (ECW), and cognitive switching abilities are associated with mobility performance, making these key determinants of mobility intervention targets to enhance mobility in older adults. The objective of this study was to compare, in the same design, the impact of three training methods - each known to improve either CRF, ECW, or cognitive switching abilities - on mobility in healthy older adults. METHODS Seventy-eight participants (69.28 ± 4.85yo) were randomly assigned to one of three twelve-week interventions: Aerobic Exercise (AE; n = 26), Gross Motor Abilities (GMA; n = 27), or Cognitive (COG; n = 25) training. Each intervention was designed to improve one of the three key determinants of mobility (CRF, ECW, and cognitive switching). Primary outcomes (usual gait speed, and TUG performance) and the three mobility determinants were measured before and after the intervention. RESULTS Repeated-measures ANOVAs showed a time effect for TUG performance (F (1,75)  = 14.92, p < .001): all groups equally improved after the intervention (Δ TUGpost-pre , in seconds, with 95% CI: AE = -0.44 [-0.81 to -0.08]; GMA = -0.60 [-1.10 to -0.10]; COG = -0.33 [-0.71 to 0.05]). No significant between group differences were observed. CRF was improved in the AE group only (Hedges' G = 0.27, small effect), ECW and cognitive switching improved the most in the GMA (Hedges' G = -0.78, moderate effect) and COG groups (Hedges' G = -1.93, large effect) respectively. Smaller improvements in ECW were observed following AE and COG trainings (Hedges' G: AE = -0.39, COG = -0.36, both small effects) as well as in cognitive switching following AE and GMA training (Hedges' G: AE = -0.42, GMA = -0.21, both small effects). DISCUSSION This study provides further support to the notion that multiple interventional approaches (aerobic, gross motor exercise, or cognitive training) can be employed to improve functional mobility in older adults, giving them, and professionals, more options to promote healthy ageing.",2021,"CRF was improved in the AE group only (Hedges' G = 0.27, small effect), ECW and cognitive switching improved the most in the GMA","['older adults', 'Seventy-eight participants (69.28\u202f±\u202f4.85yo', 'healthy older adults']","['Aerobic Exercise (AE; n\u202f=\u202f26), Gross Motor Abilities (GMA; n\u202f=\u202f27), or Cognitive (COG; n\u202f=\u202f25) training', 'multiple interventional approaches (aerobic, gross motor exercise, or cognitive training', 'physical exercise and cognitive training interventions', 'GMA']","['time effect for TUG performance', 'functional mobility', 'Primary outcomes (usual gait speed, and TUG performance) and the three mobility determinants', 'ECW', 'ECW and cognitive switching', 'CRF']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}]",78.0,0.0239213,"CRF was improved in the AE group only (Hedges' G = 0.27, small effect), ECW and cognitive switching improved the most in the GMA","[{'ForeName': 'Kristell', 'Initials': 'K', 'LastName': 'Pothier', 'Affiliation': 'Research Centre, Institut Universitaire de Gériatrie de Montréal, Montréal, Canada; PERFORM Centre, Concordia University, Montréal, Canada; EA 2114, Psychologie des Âges de la Vie et Adaptation, University of Tours, Tours, France. Electronic address: kpothier@univ-tours.fr.'}, {'ForeName': 'Tudor', 'Initials': 'T', 'LastName': 'Vrinceanu', 'Affiliation': 'Research Centre, Institut Universitaire de Gériatrie de Montréal, Montréal, Canada; Research Centre, Montreal Heart Institute, Montréal, Canada; Department of Medicine, University of Montréal, Montréal, Canada.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Intzandt', 'Affiliation': 'Research Centre, Institut Universitaire de Gériatrie de Montréal, Montréal, Canada; PERFORM Centre, Concordia University, Montréal, Canada; Research Centre, Montreal Heart Institute, Montréal, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bosquet', 'Affiliation': 'Laboratory MOVE (EA 6314), Faculty of Sport Sciences, University of Poitiers, Poitiers, France.'}, {'ForeName': 'Antony D', 'Initials': 'AD', 'LastName': 'Karelis', 'Affiliation': ""Research Centre, Institut Universitaire de Gériatrie de Montréal, Montréal, Canada; Département des Sciences de l'Activité Physique, Université du Québec à Montréal, Montréal, QC, Canada.""}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Lussier', 'Affiliation': 'Research Centre, Institut Universitaire de Gériatrie de Montréal, Montréal, Canada; Rehabilitation Science, Faculty of Medicine, University of Montréal, Montréal, Canada.'}, {'ForeName': 'T T Minh', 'Initials': 'TTM', 'LastName': 'Vu', 'Affiliation': ""Department of Medicine, University of Montréal, Montréal, Canada; Research Centre, Centre hospitalier de l'Université de Montréal, Montréal, Canada.""}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Nigam', 'Affiliation': 'Research Centre, Montreal Heart Institute, Montréal, Canada; Department of Medicine, University of Montréal, Montréal, Canada.'}, {'ForeName': 'Karen Z H', 'Initials': 'KZH', 'LastName': 'Li', 'Affiliation': 'PERFORM Centre, Concordia University, Montréal, Canada; Department of Psychology, Concordia University, Montreal, QC, Canada; Centre for Research in Human Development, Concordia University, Montreal, QC, Canada.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Berryman', 'Affiliation': ""Research Centre, Institut Universitaire de Gériatrie de Montréal, Montréal, Canada; Laboratory MOVE (EA 6314), Faculty of Sport Sciences, University of Poitiers, Poitiers, France; Département des Sciences de l'Activité Physique, Université du Québec à Montréal, Montréal, QC, Canada; Department of Sports Studies, Bishop's University, Sherbrooke, Canada.""}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Bherer', 'Affiliation': 'Research Centre, Institut Universitaire de Gériatrie de Montréal, Montréal, Canada; PERFORM Centre, Concordia University, Montréal, Canada; Research Centre, Montreal Heart Institute, Montréal, Canada; Department of Medicine, University of Montréal, Montréal, Canada. Electronic address: louis.bherer@umontreal.ca.'}]",Experimental gerontology,['10.1016/j.exger.2021.111331'] 2672,33762220,"Exposure to gamma tACS in Alzheimer's disease: A randomized, double-blind, sham-controlled, crossover, pilot study.","OBJECTIVE To assess whether exposure to non-invasive brain stimulation with transcranial alternating current stimulation at γ frequency (γ-tACS) applied over Pz (an area overlying the medial parietal cortex and the precuneus) can improve memory and modulate cholinergic transmission in mild cognitive impairment due to Alzheimer's disease (MCI-AD). METHODS In this randomized, double-blind, sham controlled, crossover pilot study, participants were assigned to a single 60 min treatment with exposure to γ-tACS over Pz or sham tACS. Each subject underwent a clinical evaluation including assessment of episodic memory pre- and post-γ-tACS or sham stimulation. Indirect measures of cholinergic transmission evaluated using transcranial magnetic stimulation (TMS) pre- and post-γ-tACS or sham tACS were evaluated. RESULTS Twenty MCI-AD participants completed the study. No tACS-related side effects were observed, and the intervention was well tolerated in all participants. We observed a significant improvement at the Rey auditory verbal learning (RAVL) test total recall (5.7 [95% CI, 4.0 to 7.4], p < 0.001) and long delayed recall scores (1.3 [95% CI, 0.4 to 2.1], p = 0.007) after γ-tACS but not after sham tACS. Face-name associations scores improved during γ-tACS (4.3 [95% CI, 2.8 to 5.8], p < 0.001) but not after sham tACS. Short latency afferent inhibition, an indirect measure of cholinergic transmission evaluated with TMS, increased only after γ-tACS (0.31 [95% CI, 0.24 to 0.38], p < 0.001) but not after sham tACS. CONCLUSIONS exposure to γ-tACS over Pz showed a significant improvement of memory performances, along with restoration of intracortical connectivity measures of cholinergic neurotransmission, compared to sham tACS.",2021,"We observed a significant improvement at the Rey auditory verbal learning (RAVL) test total recall (5.7 [95% CI, 4.0 to 7.4], p<0.001) and long delayed recall scores (1.3 [95% CI, 0.4 to 2.1], p=0.007) after γ-tACS but not after sham tACS.","['Twenty MCI-AD participants completed the study', ""mild cognitive impairment due to Alzheimer's disease (MCI-AD"", ""Alzheimer's disease""]","['transcranial alternating current stimulation at γ frequency (γ-tACS) applied over Pz', 'γ-tACS over Pz or sham tACS', 'transcranial magnetic stimulation (TMS) pre- and post-γ-tACS or sham tACS', 'gamma tACS', 'episodic memory pre- and post-γ-tACS or sham stimulation']","['memory performances', 'delayed recall scores', 'side effects', 'Rey auditory verbal learning (RAVL) test total recall']","[{'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C1285654', 'cui_str': 'Memory performance'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.438899,"We observed a significant improvement at the Rey auditory verbal learning (RAVL) test total recall (5.7 [95% CI, 4.0 to 7.4], p<0.001) and long delayed recall scores (1.3 [95% CI, 0.4 to 2.1], p=0.007) after γ-tACS but not after sham tACS.","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Benussi', 'Affiliation': 'Neurology Unit, Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy; Neurology Unit, Department of Neurological and Vision Sciences, ASST Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Cantoni', 'Affiliation': 'Neurology Unit, Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Maria Sofia', 'Initials': 'MS', 'LastName': 'Cotelli', 'Affiliation': 'Neurology Unit, Valle Camonica Hospital, Esine, Brescia, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Cotelli', 'Affiliation': 'Neuropsychology Unit, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Brattini', 'Affiliation': 'Neurology Unit, Department of Neurological and Vision Sciences, ASST Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Datta', 'Affiliation': 'Research & Development, Soterix Medical, Inc., New York, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Thomas', 'Affiliation': 'Research & Development, Soterix Medical, Inc., New York, USA.'}, {'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Santarnecchi', 'Affiliation': 'Berenson-Allen Center for Non-Invasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA; Department of Neurology, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Pascual-Leone', 'Affiliation': 'Department of Neurology, Harvard Medical School, Boston, MA, USA; Hinda and Arthur Marcus Institute for Aging Research and Center for Memory Health, Hebrew SeniorLife, Boston, MA, USA; Guttmann Brain Health Institut, Institut Guttmann, Universitat Autonoma Barcelona, Spain.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Borroni', 'Affiliation': 'Neurology Unit, Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy; Neurology Unit, Department of Neurological and Vision Sciences, ASST Spedali Civili, Brescia, Italy. Electronic address: bborroni@inwind.it.'}]",Brain stimulation,['10.1016/j.brs.2021.03.007'] 2673,33762197,"Quadratus lumborum block (transmuscular approach) versus transversus abdominis plane block (unilateral subcostal approach) for perioperative analgesia in patients undergoing open nephrectomy: a randomized, double-blinded, controlled trial.","STUDY OBJECTIVE Patients undergoing open nephrectomy surgery experience severe perioperative pain, which is primarily due to incision of several muscles. Abdominal wall blocks are known to reduce pain without causing epidural-associated hypotension. We conducted this study to compare unilateral ultrasound-guided transmuscular quadratus lumborum block and posterior transversus abdominis block in combination with general anesthesia alone in terms of intraoperative and postoperative analgesics and hemodynamics and postoperative complications. METHODS This was a randomized, double-blinded, controlled trial conducted in the operating room. This study included 48 patients aged 20-60 years, with ASA I and II, and a body mass index ≤ 30kg.m -2 who were scheduled for open nephrectomy procedure.The 48 patients scheduled for nephrectomy were randomly allocated into one of the following three groups after induction of general anesthesia: Group A (n=16) received USG transmuscular QLB; Group B (n=16) received unilateral USG posterior transversus abdominis plane (TAP) block; and Group C (n=16; control group) did not receive any blocks. Introperative fentanyl consumption, and hemodynamics (heart rate and mean arterial pressure (MAP)) were recorded after anesthesia induction, at surgical incision, and every 15min till the end of surgery. Visual Analogue Scale (VAS) was evaluated immediately at 30min and 1,2,4,6, and 12hours postoperatively. The time of first analgesic request was also recorded. RESULTS Intraoperative fentanyl consumption (μg) was significantly lower in Groups A and B (164.69±27.35 and 190.31±44.48, respectively) than in Group C (347.50±63.64) (p<0.001). Postoperatively, total pethidine consumption was significantly lower in Groups A and B than in Group C (85.31±6.68, 84.06±4.17mg, and 152.19±43.43mg, respectively) (p<0.001. Time to rescue analgesia was longer in Groups A and B than in Group C (138.75±52.39min, 202.50±72.25min, and 37.50±13.42min, respectively) (p<0.001). VAS score was significantly lower in Groups A and B than in Group C at 30min and 1, 2, 4, and 6hours postoperatively. CONCLUSION Transmuscular quadratus lumborum block and posterior transversus abdominis blocks were effective in providing perioperative analgesia in patients undergoing open nephrectomy. However, quadratus lumborum block provided superior analgesia.",2021,Transmuscular quadratus lumborum block and posterior transversus abdominis blocks were effective in providing perioperative analgesia in patients undergoing open nephrectomy.,"['48 patients scheduled for nephrectomy', 'patients undergoing open nephrectomy', 'Patients undergoing open nephrectomy surgery experience severe perioperative pain', '48 patients aged 20-60 years, with ASAI and II and a body mass index ≤ 30kg.m -2 who were scheduled for open nephrectomy procedure']","['USG transmuscular QLB', 'unilateral USG posterior transversus abdominis plane (TAP) block; and Group C (n=16; control group) did not receive any blocks', 'Quadratus lumborum block (transmuscular approach) versus transversus abdominis plane block (unilateral subcostal approach', 'Transmuscular quadratus lumborum block and posterior transversus abdominis blocks', 'unilateral ultrasound-guided transmuscular quadratus lumborum block and posterior transversus abdominis block in combination with general anesthesia alone']","['VAS score', 'total pethidine consumption', 'time of first analgesic request', 'Time to rescue analgesia', 'Visual Analogue Scale (VAS', 'Introperative fentanyl consumption, and hemodynamics (heart rate and mean arterial pressure (MAP']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0027695', 'cui_str': 'Kidney excision'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0442184', 'cui_str': 'Subcostal'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0224378', 'cui_str': 'Structure of transversus abdominis muscle'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025376', 'cui_str': 'Meperidine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0024779', 'cui_str': 'Maps'}]",48.0,0.216511,Transmuscular quadratus lumborum block and posterior transversus abdominis blocks were effective in providing perioperative analgesia in patients undergoing open nephrectomy.,"[{'ForeName': 'Amany H', 'Initials': 'AH', 'LastName': 'Saleh', 'Affiliation': 'Cairo University, Kasr Al Aini Hospital, Cairo, Egypt. Electronic address: dr_amanyhassan@hotmail.com.'}, {'ForeName': 'Mai W', 'Initials': 'MW', 'LastName': 'Abdallah', 'Affiliation': 'Cairo University, Kasr Al Aini Hospital, Cairo, Egypt.'}, {'ForeName': 'Ashraf M', 'Initials': 'AM', 'LastName': 'Mahrous', 'Affiliation': 'Cairo University, Kasr Al Aini Hospital, Cairo, Egypt.'}, {'ForeName': 'Norhan A', 'Initials': 'NA', 'LastName': 'Ali', 'Affiliation': 'Cairo University, Kasr Al Aini Hospital, Cairo, Egypt.'}]",Brazilian journal of anesthesiology (Elsevier),['10.1016/j.bjane.2021.01.009'] 2674,33762196,Effect of ketamine on emergence agitation following septoplasty: a randomized clinical trial.,"BACKGROUND AND OBJECTIVES The risk of emergence agitation (EA) is high in patients undergoing nasal surgery. The aim of the present study was to investigate the incidence of EA in adults undergoing septoplasty and the effect of ketamine on EA. METHODS In this randomized study, a total of 102 ASA I-II patients who underwent septoplasty between July 2018 and April 2019 were divided into two groups: ketamine (Group-K, n=52) and saline (Group-S, n=50). After anesthesia induction, Group-K was intravenously administered 20mL of saline containing 1mgkg -1 ketamine, whereas Group-S was administered 20mL of saline. Sedation and agitation scores at emergence from anesthesia, incidence of cough, emergence time, and response to verbal stimuli time were recorded. The sedation/agitation and pain levels were recorded for 30minutes in the recovery unit. RESULTS There was no significant difference between the groups in terms of the incidence of EA (Group-K: 15.4%, Group-S: 24%). The incidence of cough during emergence was higher in Group-S than in Group-K, but the response time to verbal stimuli and emergence time were shorter in Group-S. The sedation and agitation scores were similar after surgery. Pain scores were higher in Group-S at the time of admission to the recovery unit and were similar between groups in the other time points. CONCLUSION Administration of 1mgkg -1 ketamine after anesthesia induction does not affect the incidence of EA in patients undergoing septoplasty, but it prolongs the emergence and response time to verbal stimuli and reduces the incidence of cough.",2021,"Pain scores were higher in Group-S at the time of admission to the recovery unit and were similar between groups in the other time points. ","['102 ASA I-II patients who underwent septoplasty between July 2018 and April 2019', 'septoplasty', 'patients undergoing nasal surgery', 'patients undergoing septoplasty', 'adults undergoing septoplasty']","['ketamine', 'saline', 'saline containing 1mgkg -1 ketamine, whereas Group-S was administered 20mL of saline']","['Pain scores', 'incidence of cough during emergence', 'response time to verbal stimuli and emergence time', 'emergence agitation', 'risk of Emergence Agitation (EA', 'incidence of cough', 'incidence of EA', 'sedation/agitation and pain levels', 'Sedation and agitation scores at emergence from anesthesia, incidence of cough, emergence time, and response to verbal stimuli time', 'sedation and agitation scores']","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0844334', 'cui_str': 'Septoplasty'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0188970', 'cui_str': 'Operation on nose'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0441853', 'cui_str': 'Group S'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0920253', 'cui_str': 'Agitated Emergence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1301785', 'cui_str': 'Emergence from anesthesia'}]",102.0,0.0803425,"Pain scores were higher in Group-S at the time of admission to the recovery unit and were similar between groups in the other time points. ","[{'ForeName': 'Süheyla', 'Initials': 'S', 'LastName': 'Abitağaoğlu', 'Affiliation': 'University of Health Sciences Fatih Sultan Mehmet Health Application and Research Center, Anesthesiology and Reanimation Department, Istanbul, Turkey. Electronic address: suheylaatay81@gmail.com.'}, {'ForeName': 'Ceren', 'Initials': 'C', 'LastName': 'Köksal', 'Affiliation': 'University of Health Sciences Fatih Sultan Mehmet Health Application and Research Center, Anesthesiology and Reanimation Department, Istanbul, Turkey.'}, {'ForeName': 'Sevgi', 'Initials': 'S', 'LastName': 'Alagöz', 'Affiliation': 'University of Health Sciences Fatih Sultan Mehmet Health Application and Research Center, Anesthesiology and Reanimation Department, Istanbul, Turkey.'}, {'ForeName': 'Ceren Şanlı', 'Initials': 'CŞ', 'LastName': 'Karip', 'Affiliation': 'University of Health Sciences Fatih Sultan Mehmet Health Application and Research Center, Anesthesiology and Reanimation Department, Istanbul, Turkey.'}, {'ForeName': 'Dilek Erdoğan', 'Initials': 'DE', 'LastName': 'Arı', 'Affiliation': 'University of Health Sciences Fatih Sultan Mehmet Health Application and Research Center, Anesthesiology and Reanimation Department, Istanbul, Turkey.'}]",Brazilian journal of anesthesiology (Elsevier),['10.1016/j.bjane.2020.12.027'] 2675,33764299,Mother brain is wired for social moments.,"Reorganization of the maternal brain upon childbirth triggers the species-typical maternal social behavior. These brief social moments carry profound effects on the infant's brain and likely have a distinct signature in the maternal brain. Utilizing a double-blind, within-subject oxytocin/placebo administration crossover design, mothers' brain was imaged twice using fMRI while observing three naturalistic maternal-infant contexts in the home ecology; 'unavailable', 'unresponsive', and 'social', when mothers engaged in synchronous peek-a-boo play. The social condition elicited greater neural response across the human caregiving network, including amygdala, VTA, hippocampus, insula, ACC, and temporal cortex. Oxytocin impacted neural response primarily to the social condition and attenuated differences between social and non-social stimuli. Greater temporal consistency emerged in the 'social' condition across the two imaging sessions, particularly in insula, amygdala, and TP. Findings describe how mother's brain varies by caregiving experiences and gives salience to moments of social synchrony that support infant development and brain maturation.",2021,"Greater temporal consistency emerged in the 'social' condition across the two imaging sessions, particularly in insula, amygdala, and TP.",[],"['oxytocin/placebo', 'Oxytocin']","['amygdala, VTA, hippocampus, insula, ACC, and temporal cortex']",[],"[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0175405', 'cui_str': 'Ventral Tegmental Area of Tsai'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0175754', 'cui_str': 'Agenesis of corpus callosum'}, {'cui': 'C0039485', 'cui_str': 'Temporal lobe structure'}]",3.0,0.0470444,"Greater temporal consistency emerged in the 'social' condition across the two imaging sessions, particularly in insula, amygdala, and TP.","[{'ForeName': 'Ortal', 'Initials': 'O', 'LastName': 'Shimon-Raz', 'Affiliation': 'IDC Herzliya, Bar Ilan University, Ramat Gan, Israel.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Salomon', 'Affiliation': 'Gonda Brain Research Center, Bar Ilan University, Ramat Gan, Israel.'}, {'ForeName': 'Miki', 'Initials': 'M', 'LastName': 'Bloch', 'Affiliation': 'Department of Psychiatry, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Gabi', 'Initials': 'G', 'LastName': 'Aisenberg Romano', 'Affiliation': 'Department of Psychiatry, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Yaara', 'Initials': 'Y', 'LastName': 'Yeshurun', 'Affiliation': 'School of Psychological Sciences, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Ulmer Yaniv', 'Affiliation': 'IDC Herzliya, Bar Ilan University, Ramat Gan, Israel.'}, {'ForeName': 'Orna', 'Initials': 'O', 'LastName': 'Zagoory-Sharon', 'Affiliation': 'IDC Herzliya, Bar Ilan University, Ramat Gan, Israel.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Feldman', 'Affiliation': 'IDC Herzliya, Bar Ilan University, Ramat Gan, Israel.'}]",eLife,['10.7554/eLife.59436'] 2676,33824131,E-health StandingTall balance exercise for fall prevention in older people: results of a two year randomised controlled trial.,"OBJECTIVE To test whether StandingTall, a home based, e-health balance exercise programme delivered through an app, could provide an effective, self-managed fall prevention programme for community dwelling older people. DESIGN Assessor blinded, randomised controlled trial. SETTING Older people living independently in the community in Sydney, Australia. PARTICIPANTS 503 people aged 70 years and older who were independent in activities of daily living, without cognitive impairment, progressive neurological disease, or any other unstable or acute medical condition precluding exercise. INTERVENTIONS Participants were block randomised to an intervention group (two hours of StandingTall per week and health education; n=254) or a control group (health education; n=249) for two years. MAIN OUTCOME MEASURES The primary outcomes were the rate of falls (number of falls per person year) and the proportion of people who had a fall over 12 months. Secondary outcomes were the number of people who had a fall and the number who had an injurious fall (resulting in any injury or requiring medical care), adherence, mood, health related quality of life, and activity levels over 24 months; and balance and mobility outcomes over 12 months. RESULTS The fall rates were not statistically different in the two groups after the first 12 months (0.60 falls per year (standard deviation 1.05) in the intervention group; 0.76 (1.25) in the control group; incidence rate ratio 0.84, 95% confidence interval 0.62 to 1.13, P=0.071). Additionally, the proportion of people who fell was not statistically different at 12 months (34.6% in intervention group, 40.2% in control group; relative risk 0.90, 95% confidence interval 0.67 to 1.20, P=0.461). However, the intervention group had a 16% lower rate of falls over 24 months compared with the control group (incidence rate ratio 0.84, 95% confidence interval 0.72 to 0.98, P=0.027). Both groups had a similar proportion of people who fell over 24 months (relative risk 0.87, 95% confidence interval 0.68 to 1.10, P=0.239), but the proportion of people who had an injurious fall over 24 months was 20% lower in the intervention group compared with the control group (relative risk 0.80, 95% confidence interval 0.66 to 0.98, P=0.031). In the intervention group, 68.1% and 52.0% of participants exercised for a median of 114.0 min/week (interquartile range 53.5) after 12 months and 120.4 min/week (38.6) after 24 months, respectively. Groups remained similar in mood and activity levels. The intervention group had a 0.03 (95% confidence interval 0.01 to 0.06) improvement on the EQ-5D-5L (EuroQol five dimension five level) utility score at six months, and an improvement in standing balance of 11 s (95% confidence interval 2 to 19 s) at six months and 10 s (1 to 19 s) at 12 months. No serious training related adverse events occurred. CONCLUSIONS The StandingTall balance exercise programme did not significantly affect the primary outcomes of this study. However, the programme significantly reduced the rate of falls and the number of injurious falls over two years, with similar but not statistically significant effects at 12 months. E-health exercise programmes could provide promising scalable fall prevention strategies. TRIAL REGISTRATION ACTRN12615000138583.",2021,"The fall rates were not statistically different in the two groups after the first 12 months (0.60 falls per year (standard deviation 1.05) in the intervention group; 0.76 (1.25) in the control group; incidence rate ratio 0.84, 95% confidence interval 0.62 to 1.13, P=0.071).","['older people', '503 people aged 70 years and older who were independent in activities of daily living, without cognitive impairment, progressive neurological disease, or any other unstable or acute medical condition precluding exercise', 'Older people living independently in the community in Sydney, Australia', 'community dwelling older people']","['E-health StandingTall balance exercise', 'StandingTall balance exercise programme']","['mood and activity levels', 'fall rates', 'standing balance', 'rate of falls (number of falls per person year) and the proportion of people who had a fall over 12 months', 'injurious fall', 'proportion of people who fell', 'number of people who had a fall and the number who had an injurious fall (resulting in any injury or requiring medical care), adherence, mood, health related quality of life, and activity levels over 24 months; and balance and mobility outcomes', 'rate of falls and the number of injurious falls', 'EQ-5D-5L (EuroQol five dimension five level) utility score', 'rate of falls']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0027765', 'cui_str': 'Disorder of nervous system'}, {'cui': 'C0443343', 'cui_str': 'Unstable status'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1561668', 'cui_str': 'History of fall'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",503.0,0.111248,"The fall rates were not statistically different in the two groups after the first 12 months (0.60 falls per year (standard deviation 1.05) in the intervention group; 0.76 (1.25) in the control group; incidence rate ratio 0.84, 95% confidence interval 0.62 to 1.13, P=0.071).","[{'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Delbaere', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, Randwick, NSW, Australia k.delbaere@neura.edu.au.'}, {'ForeName': 'Trinidad', 'Initials': 'T', 'LastName': 'Valenzuela', 'Affiliation': 'Faculty of Medicine and Health, School of Public Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Lord', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, Randwick, NSW, Australia.'}, {'ForeName': 'Lindy', 'Initials': 'L', 'LastName': 'Clemson', 'Affiliation': 'Faculty of Medicine and Health, School of Public Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'G A Rixt', 'Initials': 'GAR', 'LastName': 'Zijlstra', 'Affiliation': 'Care and Public Health Research Institute, Department of Health Services Research, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Jacqueline C T', 'Initials': 'JCT', 'LastName': 'Close', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, Randwick, NSW, Australia.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lung', 'Affiliation': 'Faculty of Medicine and Health, School of Public Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Woodbury', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, Randwick, NSW, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Chow', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, Randwick, NSW, Australia.'}, {'ForeName': 'Garth', 'Initials': 'G', 'LastName': 'McInerney', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, Randwick, NSW, Australia.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Miles', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, Randwick, NSW, Australia.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Toson', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, Randwick, NSW, Australia.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Briggs', 'Affiliation': 'Stats Central, Mark Wainwright Analytical Centre, University of New South Wales, Kensington, NSW, Australia.'}, {'ForeName': 'Kimberley S', 'Initials': 'KS', 'LastName': 'van Schooten', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, Randwick, NSW, Australia.'}]",BMJ (Clinical research ed.),['10.1136/bmj.n740'] 2677,33767162,Association of CYP2D6 genotype and tamoxifen metabolites with breast cancer recurrence in a low-dose trial.,"Low-dose tamoxifen halves recurrence in non-invasive breast cancer without significant adverse events. Some adjuvant trials with tamoxifen 20 mg/day had shown an association between low endoxifen levels (9-16 nM) and recurrence, but no association with CYP2D6 was shown in the NSABP P1 and P2 prevention trials. We studied the association of CYP2D6 genotype and tamoxifen metabolites with tumor biomarkers and recurrence in a randomized phase III trial of low-dose tamoxifen. Median (IQR) endoxifen levels at year 1 were 8.4 (5.3-11.4) in patients who recurred vs 7.5 (5.1-10.2) in those who did not recur (p = 0.60). Tamoxifen and metabolites significantly decreased C-reactive protein (CRP, p < 0.05), and a CRP increase after 3 years was associated with higher risk of recurrence (HR = 4.37, 95% CI, 1.14-16.73, P = 0.03). In conclusion, endoxifen is below 9 nM in most subjects treated with 5 mg/day despite strong efficacy and there is no association with recurrence, suggesting that the reason for tamoxifen failure is not poor drug metabolism. Trial registration: ClinicalTrials.gov, Identifier: NCT01357772 .",2021,"Tamoxifen and metabolites significantly decreased C-reactive protein (CRP, p < 0.05), and a CRP increase after 3 years was associated with higher risk of recurrence (HR = 4.37, 95% CI, 1.14-16.73, P = 0.03).",[],"['tamoxifen metabolites', 'endoxifen', 'Low-dose tamoxifen', 'Tamoxifen', 'tamoxifen']","['Median (IQR) endoxifen levels', 'risk of recurrence', 'low endoxifen levels', 'CRP increase', 'C-reactive protein']",[],"[{'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0048311', 'cui_str': '4-hydroxy-N-desmethyltamoxifen'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0048311', 'cui_str': '4-hydroxy-N-desmethyltamoxifen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0742906', 'cui_str': 'Elevated C-reactive protein'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",,0.125554,"Tamoxifen and metabolites significantly decreased C-reactive protein (CRP, p < 0.05), and a CRP increase after 3 years was associated with higher risk of recurrence (HR = 4.37, 95% CI, 1.14-16.73, P = 0.03).","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'DeCensi', 'Affiliation': 'Division of Medical Oncology, E.O. Galliera Hospital, Genoa, Italy. andrea.decensi@galliera.it.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Johansson', 'Affiliation': 'Division of Cancer Prevention and Genetics, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Helland', 'Affiliation': 'Hormone Laboratory, Department of Medical Biochemistry and Pharmacology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Puntoni', 'Affiliation': 'Clinical Trial Unit, Office of the Scientific Director, E.O. Galliera Hospital, Genoa, Italy.'}, {'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Macis', 'Affiliation': 'Division of Cancer Prevention and Genetics, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Aristarco', 'Affiliation': 'Division of Cancer Prevention and Genetics, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Caviglia', 'Affiliation': 'Division of Medical Oncology, E.O. Galliera Hospital, Genoa, Italy.'}, {'ForeName': 'Tania Buttiron', 'Initials': 'TB', 'LastName': 'Webber', 'Affiliation': 'Division of Medical Oncology, E.O. Galliera Hospital, Genoa, Italy.'}, {'ForeName': 'Irene Maria', 'Initials': 'IM', 'LastName': 'Briata', 'Affiliation': 'Division of Medical Oncology, E.O. Galliera Hospital, Genoa, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': ""D'Amico"", 'Affiliation': 'Division of Medical Oncology, E.O. Galliera Hospital, Genoa, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Serrano', 'Affiliation': 'Division of Cancer Prevention and Genetics, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Aliana', 'Initials': 'A', 'LastName': 'Guerrieri-Gonzaga', 'Affiliation': 'Division of Cancer Prevention and Genetics, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Ersilia', 'Initials': 'E', 'LastName': 'Bifulco', 'Affiliation': 'Department of Clinical Science, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Steinar', 'Initials': 'S', 'LastName': 'Hustad', 'Affiliation': 'Department of Clinical Science, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Håvard', 'Initials': 'H', 'LastName': 'Søiland', 'Affiliation': 'Department of Clinical Science, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Boni', 'Affiliation': 'IRCCS San Martino Hospital, Genoa, Italy.'}, {'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Bonanni', 'Affiliation': 'Division of Cancer Prevention and Genetics, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Mellgren', 'Affiliation': 'Department of Clinical Science, University of Bergen, Bergen, Norway.'}]",NPJ breast cancer,['10.1038/s41523-021-00236-6'] 2678,33766814,A Surgical Window Trial Evaluating Medroxyprogesterone Acetate with or without Entinostat in Patients with Endometrial Cancer and Validation of Biomarkers of Cellular Response.,"PURPOSE This surgical window of opportunity (window) study assessed the short-term effect of medroxyprogesterone acetate (MPA) alone versus MPA plus the histone deacetylase (HDAC) inhibitor entinostat on regulation of progesterone receptor (PR) in women with newly diagnosed endometrioid endometrial adenocarcinoma. PATIENTS AND METHODS This multisite, randomized, open-label surgical window study treated women intramuscularly on day 1 with 400 mg MPA. Entinostat given 5 mg by mouth on days 1, 8, and 15 was randomly assigned with equal probability. Surgery followed on days 21-24. Pretreatment and posttreatment tissue was assessed for PR H-scores, Ki-67 levels, and histologic response. RESULTS Fifty patients were accrued in 4 months; 22 and 20 participants had PR evaluable pretreatment and posttreatment slides in the MPA and MPA/entinostat arms, respectively. Median posttreatment PR H-scores were significantly lower than pretreatment H-scores in both arms but did not differ significantly (MPA: 247 vs. 27, MPA/entinostat 260 vs. 23, respectively, P = 0.87). Decreased Ki-67 was shown in 90% treated with MPA/entinostat compared with 68% treated with MPA alone ( P = 0.13). Median PR H-score decreases were larger when Ki-67 was decreased (208) versus not decreased (45). The decrease in PR pretreatment versus posttreatment was associated with loss of Ki-67 nuclear staining, consistent with reduced cellular proliferation ( P < 0.008). CONCLUSIONS This surgical window trial rapidly accrued in a multisite setting and evaluated PR as its primary endpoint and Ki-67 as secondary endpoint. Despite no immediate effect of entinostat on PR in this short-term study, lessons learned can inform future window and treatment trials.",2021,"Median posttreatment PR H-scores were significantly lower than pretreatment H-scores in both arms but did not differ significantly (MPA: 247 vs. 27, MPA/entinostat","['women with newly diagnosed endometrioid endometrial adenocarcinoma', 'Patients with Endometrial Cancer and Validation of Biomarkers of Cellular Response']","['MPA', 'Medroxyprogesterone Acetate with or without Entinostat', '400 mg MPA', 'medroxyprogesterone acetate (MPA) alone versus MPA plus the histone deacetylase (HDAC) inhibitor entinostat']","['Decreased Ki-67', 'Median PR H-score decreases', 'PR H-scores, Ki-67 levels, and histologic response', 'cellular proliferation', 'Median posttreatment PR H-scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1336905', 'cui_str': 'Primary endometrioid carcinoma of endometrium of body of uterus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}]","[{'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}, {'cui': 'C2743752', 'cui_str': 'entinostat'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0019643', 'cui_str': 'Histone Deacetylase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0034833', 'cui_str': 'Progesterone receptor'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}]",50.0,0.033145,"Median posttreatment PR H-scores were significantly lower than pretreatment H-scores in both arms but did not differ significantly (MPA: 247 vs. 27, MPA/entinostat","[{'ForeName': 'Linda R', 'Initials': 'LR', 'LastName': 'Duska', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of Virginia School of Medicine, Charlottesville, Virginia. lduska@virginia.edu.'}, {'ForeName': 'Virginia L', 'Initials': 'VL', 'LastName': 'Filiaci', 'Affiliation': 'NRG Oncology SDMC, CTD Division, Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}, {'ForeName': 'Joan L', 'Initials': 'JL', 'LastName': 'Walker', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Holman', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Emily K', 'Initials': 'EK', 'LastName': 'Hill', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Iowa Hospitals and Clinics, Iowa City, Iowa.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Moore', 'Affiliation': 'Department of Obstetrics and Gynecology, Wilmont Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Kari L', 'Initials': 'KL', 'LastName': 'Ring', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of Virginia School of Medicine, Charlottesville, Virginia.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Pearl', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Medicine, Division of Gynecologic Oncology, Stony Brook University Medical Center, Stony Brook, New York.'}, {'ForeName': 'Carolyn Y', 'Initials': 'CY', 'LastName': 'Muller', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of New Mexico, Albuquerque, New Mexico.'}, {'ForeName': 'Christina L', 'Initials': 'CL', 'LastName': 'Kushnir', 'Affiliation': ""Department of Obstetrics and Gynecology, Women's Cancer Center, Las Vegas, Nevada.""}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Lankes', 'Affiliation': 'NRG Oncology, Operations Center-Philadelphia East, Philadelphia, Pennsylvania.'}, {'ForeName': 'Megan I', 'Initials': 'MI', 'LastName': 'Samuelson', 'Affiliation': 'Department of Pathology, University of Iowa Hospitals and Clinics, Iowa City, Iowa.'}, {'ForeName': 'Kelley S', 'Initials': 'KS', 'LastName': 'Carrick', 'Affiliation': 'Department of Pathology, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Rajan', 'Affiliation': 'Department of Pathology, University of Iowa Hospitals and Clinics, Iowa City, Iowa.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Rodgers', 'Affiliation': 'Department of Pathology, New York Hospital Queens, Weill Medical College of Cornell University, Flushing, New York.'}, {'ForeName': 'Elise C', 'Initials': 'EC', 'LastName': 'Kohn', 'Affiliation': 'Cancer Therapy Evaluation Program, NCI, Rockville, Maryland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Piekarz', 'Affiliation': 'Cancer Therapy Evaluation Program, NCI, Rockville, Maryland.'}, {'ForeName': 'Kimberly K', 'Initials': 'KK', 'LastName': 'Leslie', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Iowa Hospitals and Clinics, Iowa City, Iowa.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-4618'] 2679,33766422,"Nasopharyngeal carriage of otitis media pathogens in infants receiving 10-valent non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10), 13-valent pneumococcal conjugate vaccine (PCV13) or a mixed primary schedule of both vaccines: A randomised controlled trial.","BACKGROUND Aboriginal children in Northern Australia have a high burden of otitis media, driven by early and persistent nasopharyngeal carriage of otopathogens, including non-typeable Haemophilus influenzae (NTHi) and Streptococcus pneumoniae (Spn). In this context, does a combined mixed primary series of Synflorix and Prevenar13 provide better protection against nasopharyngeal carriage of NTHi and Spn serotypes 3, 6A and 19A than either vaccine alone? METHODS Aboriginal infants (n = 425) were randomised to receive Synflorix™ (S, PHiD-CV10) or Prevenar13™ (P, PCV13) at 2, 4 and 6 months (_SSS or _PPP, respectively), or a 4-dose early mixed primary series of PHiD-CV10 at 1, 2 and 4 months and PCV13 at 6 months of age (SSSP). Nasopharyngeal swabs were collected at 1, 2, 4, 6 and 7 months of age. Swabs of ear discharge were collected from tympanic membrane perforations. FINDINGS At the primary endpoint at 7 months of age, the proportion of nasopharyngeal (Np) swabs positive for PCV13-only serotypes 3, 6A, or 19A was 0%, 0.8%, and 1.5% in the _PPP, _SSS, and SSSP groups respectively, and NTHi 55%, 52%, and 52% respectively, and no statistically significant vaccine group differences in other otopathogens at any age. The most common serotypes (in order) were 16F, 11A, 10A, 7B, 15A, 6C, 35B, 23B, 13, and 15B, accounting for 65% of carriage. Ear discharge swabs (n = 108) were culture positive for NTHi (52%), S. aureus (32%), and pneumococcus (20%). CONCLUSIONS Aboriginal infants experience nasopharyngeal colonisation and tympanic membrane perforations associated with NTHi, non-PCV13 pneumococcal serotypes and S. aureus in the first months of life. Nasopharyngeal carriage of pneumococcus or NTHi was not significantly reduced in the early 4-dose combined SSSP group compared to standard _PPP or _SSS schedules at any time point. Current pneumococcal conjugate vaccine formulations do not offer protection from early onset NTHi and pneumococcal colonisation in this high-risk population.",2021,"Ear discharge swabs (n = 108) were culture positive for NTHi (52%), S. aureus (32%), and pneumococcus (20%). ","['Aboriginal children in Northern Australia', 'infants receiving 10-valent non-typeable Haemophilus influenzae protein D conjugate', 'Aboriginal infants (n\xa0', '425']","['Synflorix™ (S, PHiD-CV10) or Prevenar13™', 'vaccine', 'vaccine (PHiD-CV10), 13-valent pneumococcal conjugate vaccine (PCV13']","['proportion of nasopharyngeal (Np) swabs positive', 'Nasopharyngeal carriage of pneumococcus or NTHi', 'Nasopharyngeal carriage of otitis media pathogens']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0138826', 'cui_str': 'glpQ protein, Haemophilus influenzae'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C3844105', 'cui_str': '425'}]","[{'cui': 'C3252923', 'cui_str': 'synflorix'}, {'cui': 'C1864445', 'cui_str': 'Histiocytosis-lymphadenopathy plus syndrome'}, {'cui': 'C0450819', 'cui_str': 'CV10'}, {'cui': 'C2756364', 'cui_str': 'Prevnar 13'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C3152625', 'cui_str': 'Pneumococcal 13-valent conjugate vaccine'}]","[{'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C0018483', 'cui_str': 'Haemophilus influenzae'}, {'cui': 'C0029882', 'cui_str': 'Otitis media'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}]",425.0,0.273582,"Ear discharge swabs (n = 108) were culture positive for NTHi (52%), S. aureus (32%), and pneumococcus (20%). ","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Beissbarth', 'Affiliation': 'Child Health Division, Menzies School of Heath Research, Charles Darwin University, PO Box 41096, Casuarina, Northern Territory, Australia. Electronic address: Jemima.Beissbarth@menzies.edu.au.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Wilson', 'Affiliation': 'Child Health Division, Menzies School of Heath Research, Charles Darwin University, PO Box 41096, Casuarina, Northern Territory, Australia.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Arrowsmith', 'Affiliation': 'Child Health Division, Menzies School of Heath Research, Charles Darwin University, PO Box 41096, Casuarina, Northern Territory, Australia. Electronic address: Beth.Arrowsmith@telethonkids.org.au.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Binks', 'Affiliation': 'Child Health Division, Menzies School of Heath Research, Charles Darwin University, PO Box 41096, Casuarina, Northern Territory, Australia. Electronic address: Michael.binks@menzies.edu.au.'}, {'ForeName': 'V M', 'Initials': 'VM', 'LastName': 'Oguoma', 'Affiliation': 'Health Research Institute, University of Canberra, Canberra, ACT, Australia. Electronic address: victor.oguoma@menzies.edu.au.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Lawrence', 'Affiliation': 'Child Health Division, Menzies School of Heath Research, Charles Darwin University, PO Box 41096, Casuarina, Northern Territory, Australia. Electronic address: Katrina.lawrence@menzies.edu.au.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Llewellyn', 'Affiliation': 'Child Health Division, Menzies School of Heath Research, Charles Darwin University, PO Box 41096, Casuarina, Northern Territory, Australia. Electronic address: amy.bleakley@menzies.edu.au.'}, {'ForeName': 'E K', 'Initials': 'EK', 'LastName': 'Mulholland', 'Affiliation': ""Murdoch Children's Research Institute, Department of Paediatrics, University of Melbourne, Australia; London School of Hygiene and Tropical Medicine, UK. Electronic address: dKim.Mulholland@lshtm.ac.uk.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Santosham', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, USA. Electronic address: Msantosham@jhu.edu.'}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'Morris', 'Affiliation': 'Child Health Division, Menzies School of Heath Research, Charles Darwin University, PO Box 41096, Casuarina, Northern Territory, Australia; Department of Paediatrics, Royal Darwin Hospital, Darwin, Australia. Electronic address: Peter.morris@menzies.edu.au.'}, {'ForeName': 'H C', 'Initials': 'HC', 'LastName': 'Smith-Vaughan', 'Affiliation': 'Child Health Division, Menzies School of Heath Research, Charles Darwin University, PO Box 41096, Casuarina, Northern Territory, Australia. Electronic address: Heidi.Smith-Vaughan@menzies.edu.au.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Cheng', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Victoria, Australia; Infection Prevention and Healthcare Epidemiology Unit, Alfred Health, Victoria, Australia. Electronic address: allen.cheng@monash.edu.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Leach', 'Affiliation': 'Child Health Division, Menzies School of Heath Research, Charles Darwin University, PO Box 41096, Casuarina, Northern Territory, Australia. Electronic address: amanda.leach@menzies.edu.au.'}]",Vaccine,['10.1016/j.vaccine.2021.03.032'] 2680,33765656,Efficacy of Multidomain Intervention Against Physio-cognitive Decline Syndrome: A Cluster-randomized Trial.,"BACKGROUNDS To investigate the efficacy of a community group-based intervention among community-dwelling older adults with physio-cognitive decline syndrome (PCDS). METHODS A prospective cluster randomized controlled trial included 733 community-dwelling older adults with adjusted Montreal Cognitive Assessment (MoCA adj) scores >18 from 40 community-based sites across Taiwan. PCDS was defined as the concomitant presence of physical declines, i.e., slowness and/or weakness plus dysfunction in any cognitive domain. The multidomain intervention integrated physical exercise, cognitive training, nutritional advices and health education lessons. Conventional health education in control group entailed periodic telephone calls to offer participants health education and advice. The primary outcome was the mean differences of MoCA adj total scores and all domains of MoCA adj between baseline and 6- and 12-month follow-up in each group of PCDS, cognitive dysfunction, mobility-type frailty and normal functioning, and the secondary outcomes included the changes of frailty score, handgrip strength, gait speed and physical activity. Intervention effects were analysed using a generalized linear mixed model. RESULTS Overall, 18.9% of the study sample had PCDS. Multidomain intervention for 12 months significantly improved cognitive performance in people with PCDS, and those with cognitive dysfunction only. An early benefit on visuo-spatial executive function was seen in older adults with mobility-type frailty. Intervention also improved frailty scores among participants with mobility-type frailty, handgrip strength for participants with PCDS, and gait speed in the normal group. CONCLUSIONS PCDS is a potentially reversible condition that may prevent subsequent disability and dementia, which deserves further investigation to confirm the long-term effects.",2021,"Intervention also improved frailty scores among participants with mobility-type frailty, handgrip strength for participants with PCDS, and gait speed in the normal group. ","['Against Physio-cognitive Decline Syndrome', 'participants with mobility-type frailty, handgrip strength for participants with PCDS, and gait speed in the normal group', 'older adults with mobility-type frailty', 'participants health education and advice', '733 community-dwelling older adults with adjusted Montreal Cognitive Assessment (MoCA adj) scores >18 from 40 community-based sites across Taiwan', 'community-dwelling older adults with physio-cognitive decline syndrome (PCDS']","['community group-based intervention', 'Multidomain intervention', 'Multidomain Intervention', 'multidomain intervention integrated physical exercise, cognitive training, nutritional advices and health education lessons']","['cognitive performance', 'PCDS', 'frailty scores', 'PCDS, cognitive dysfunction, mobility-type frailty and normal functioning, and the secondary outcomes included the changes of frailty score, handgrip strength, gait speed and physical activity', 'mean differences of MoCA adj total scores and all domains of MoCA adj']","[{'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",733.0,0.0392909,"Intervention also improved frailty scores among participants with mobility-type frailty, handgrip strength for participants with PCDS, and gait speed in the normal group. ","[{'ForeName': 'Chih-Kuang', 'Initials': 'CK', 'LastName': 'Liang', 'Affiliation': 'Center for Geriatrics and Gerontology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan. No.386, Dazhong 1st Rd., Zuoying Dist., Kaohsiung City 81362, Taiwan; Division of Neurology, Department of Internal Medicine, Kaohsiung Veterans General hospital, Kaohsiung, Taiwan. No.386, Dazhong 1st Rd., Zuoying Dist., Kaohsiung City 81362, Taiwan; Aging and Health Research Center, National Yang Ming Chiao Tung University, Taipei, Taiwan. No. 155, Sec.2, Linong Street, Taipei 112 Taiwan.'}, {'ForeName': 'Wei-Ju', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'Aging and Health Research Center, National Yang Ming Chiao Tung University, Taipei, Taiwan. No. 155, Sec.2, Linong Street, Taipei 112 Taiwan; Department of Family Medicine, Taipei Veterans General Hospital, Yuanshan Branch, Yilan, Taiwan. No.386, Rongguang Rd., Neicheng, Yuanshan Township, Yilan County 264, Taiwan. Electronic address: leewju@gmail.com.'}, {'ForeName': 'An-Chun', 'Initials': 'AC', 'LastName': 'Hwang', 'Affiliation': 'Aging and Health Research Center, National Yang Ming Chiao Tung University, Taipei, Taiwan. No. 155, Sec.2, Linong Street, Taipei 112 Taiwan; Center for Geriatrics and Gerontology, Taipei Veterans General Hospital, Taipei, Taiwan. No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City 11217, Taiwan.'}, {'ForeName': 'Chu-Sheng', 'Initials': 'CS', 'LastName': 'Lin', 'Affiliation': 'Aging and Health Research Center, National Yang Ming Chiao Tung University, Taipei, Taiwan. No. 155, Sec.2, Linong Street, Taipei 112 Taiwan; Department of Family Medicine, Taichung Veterans General Hospital, Taichung, Taiwan. 1650 Taiwan Boulevard Sect. 4, Taichung 407204, Taiwan; Center for Geriatrics and Gerontology, Taichung Veterans General Hospital, Taichung, Taiwan. 1650 Taiwan Boulevard Sect. 4, Taichung 407204, Taiwan.'}, {'ForeName': 'Ming-Yueh', 'Initials': 'MY', 'LastName': 'Chou', 'Affiliation': 'Center for Geriatrics and Gerontology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan. No.386, Dazhong 1st Rd., Zuoying Dist., Kaohsiung City 81362, Taiwan; Aging and Health Research Center, National Yang Ming Chiao Tung University, Taipei, Taiwan. No. 155, Sec.2, Linong Street, Taipei 112 Taiwan.'}, {'ForeName': 'Li-Ning', 'Initials': 'LN', 'LastName': 'Peng', 'Affiliation': 'Aging and Health Research Center, National Yang Ming Chiao Tung University, Taipei, Taiwan. No. 155, Sec.2, Linong Street, Taipei 112 Taiwan; Center for Geriatrics and Gerontology, Taipei Veterans General Hospital, Taipei, Taiwan. No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City 11217, Taiwan.'}, {'ForeName': 'Ming-Hsien', 'Initials': 'MH', 'LastName': 'Lin', 'Affiliation': 'Aging and Health Research Center, National Yang Ming Chiao Tung University, Taipei, Taiwan. No. 155, Sec.2, Linong Street, Taipei 112 Taiwan; Center for Geriatrics and Gerontology, Taipei Veterans General Hospital, Taipei, Taiwan. No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City 11217, Taiwan.'}, {'ForeName': 'Liang-Kung', 'Initials': 'LK', 'LastName': 'Chen', 'Affiliation': 'Aging and Health Research Center, National Yang Ming Chiao Tung University, Taipei, Taiwan. No. 155, Sec.2, Linong Street, Taipei 112 Taiwan; Center for Geriatrics and Gerontology, Taipei Veterans General Hospital, Taipei, Taiwan. No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City 11217, Taiwan.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2021.104392'] 2681,33765633,The Effects of Upper Extremity Isokinetic Strengthening in Post-Stroke Hemiplegia: A Randomized Controlled Trial.,"OBJECTIVE The aim of this study was to evaluate the efficacy of isokinetic strengthening in paretic upper extremity among patients with post-stroke hemiplegia. METHODS Hemiplegic patients with at least 6 months post-stroke and those with arm and hand Brunnstrom motor recovery stage ≥ 3 were included to the study. Patients were randomized into two groups. Isokinetic training group received 4 weeks (3 days/week) of isokinetic strengthening, while the control group was tailored strengthening exercises with exercise bands. Outcome measures were the isokinetic peak torque of wrist flexor and extensors, Fugl-Meyer Assessment of upper extremity, Stroke Impact Scale (SIS), Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, hand grip strength, peak isometric strength of wrist flexor and extensors. Outcome measures were evaluated before treatment, after treatment (at the end of week 4) and 4 weeks after the end of treatment (at the end of week 8). The trial was registered at ClinicalTtrials.gov (ID: NCT03834311). RESULTS After 4 weeks, changes in extensor peak torque at 60°/sn (p=0.007) and extensor peak isometric muscle strength (p=0.007) were higher in the isokinetic group (n=12) than those in the control group (n=12). At the end of week 8, only DASH score revealed a significantly higher improvement in the isokinetic group than that in the control group (p=0.014). CONCLUSIONS Isokinetic strengthening may provide motor and functional improvement in paretic upper extremity among patients with post-stroke hemiplegia.",2021,(p=0.007) and extensor peak isometric muscle strength (p=0.007) were higher in the isokinetic group (n=12) than those in the control group (n=12).,"['patients with post-stroke hemiplegia', 'Post-Stroke Hemiplegia', 'Hemiplegic patients with at least 6 months post-stroke and those with arm and hand Brunnstrom motor recovery stage ≥ 3 were included to the study']","['Upper Extremity Isokinetic Strengthening', 'Isokinetic training', 'Isokinetic strengthening', 'isokinetic strengthening, while the control group was tailored strengthening exercises with exercise bands', 'isokinetic strengthening']","['extensor peak isometric muscle strength', 'DASH score', 'extensor peak torque', 'isokinetic peak torque of wrist flexor and extensors, Fugl-Meyer Assessment of upper extremity, Stroke Impact Scale (SIS), Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, hand grip strength, peak isometric strength of wrist flexor and extensors']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0175723', 'cui_str': 'Band'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}]",,0.0263856,(p=0.007) and extensor peak isometric muscle strength (p=0.007) were higher in the isokinetic group (n=12) than those in the control group (n=12).,"[{'ForeName': 'Kerim', 'Initials': 'K', 'LastName': 'Kerimov', 'Affiliation': 'Cukurova University Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Adana, Turkey. Electronic address: kkerimov81@gmail.com.'}, {'ForeName': 'Ilke', 'Initials': 'I', 'LastName': 'Coskun Benlidayi', 'Affiliation': 'Cukurova University Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Adana, Turkey. Electronic address: icbenlidayi@hotmail.com.'}, {'ForeName': 'Cigdem', 'Initials': 'C', 'LastName': 'Ozdemir', 'Affiliation': 'Cukurova University Faculty of Medicine, Department of Physiology, Adana, Turkey. Electronic address: cozdemir@cu.edu.tr.'}, {'ForeName': 'Ozgur', 'Initials': 'O', 'LastName': 'Gunasti', 'Affiliation': 'Cukurova University Faculty of Medicine, Department of Physiology, Adana, Turkey. Electronic address: ogunasti@cu.edu.tr.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2021.105729'] 2682,33765619,Autonomy support and preference-performance dissociation in choice-reaction time tasks.,"The purpose of the current study was threefold: (a) to examine the effects of participants having the autonomy to choose the practice order of two reaction time (RT) tasks - a choice-RT task and a Simon task - on performance, (b) to examine whether one order of practice is better than the other, and (c) to examine whether participants might choose a practice order that hinders their performance. The study was conducted online and participants completed the tasks on their own computer. Fifty-nine participants were randomly assigned into three groups: (a) autonomy - participants chose which task they would like to practice first, (b) choice-first - participants practiced the choice-RT task first, and (c) Simon-first - participants practiced the Simon task first. Out of these three groups we created an autonomy group (n = 17) and a no-autonomy (yoked) group (n = 17). All participants performed eight familiarization trials of each task, practiced 160 trials (8 blocks × 20 trials) of each task, and performed a post-test of 20 additional trials of each task after a three-minute rest. The main findings were that (a) participants in the autonomy group had faster RTs compared with participants in the no-autonomy group, (b) performing the choice-RT task first led to faster RTs compared with performing the Simon task first, and (c) nine of the 17 participants in the autonomy group chose to practice the Simon task first. The findings of this study suggest that providing participants with autonomy can lead to improved performance. However, there may be a dissociation between participants' preference of practice order and their performance.",2021,"The main findings were that (a) participants in the autonomy group had faster RTs compared with participants in the no-autonomy group, (b) performing the choice-RT task first led to faster RTs compared with performing the Simon task first, and (c) nine of the 17 participants in the autonomy group chose to practice the Simon task first.",['Fifty-nine participants'],"['autonomy - participants chose which task they would like to practice first, (b) choice-first - participants practiced the choice-RT task first, and (c']",['faster RTs'],"[{'cui': 'C3830128', 'cui_str': '59'}]","[{'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}]",59.0,0.176945,"The main findings were that (a) participants in the autonomy group had faster RTs compared with participants in the no-autonomy group, (b) performing the choice-RT task first led to faster RTs compared with performing the Simon task first, and (c) nine of the 17 participants in the autonomy group chose to practice the Simon task first.","[{'ForeName': 'Gal', 'Initials': 'G', 'LastName': 'Ziv', 'Affiliation': 'Motor Behavior Laboratory, The Academic College at Wingate, Netanya, Israel. Electronic address: galziv@wincol.ac.il.'}, {'ForeName': 'Ronnie', 'Initials': 'R', 'LastName': 'Lidor', 'Affiliation': 'Motor Behavior Laboratory, The Academic College at Wingate, Netanya, Israel.'}]",Human movement science,['10.1016/j.humov.2021.102786'] 2683,33765549,A randomized control trial to study the effect of integrated yoga on pregnancy outcome in hypertensive disorder of pregnancy.,"OBJECTIVE The study aimed to evaluate the effects of integrated yoga on blood pressure and pregnancy outcome in hypertensive disorder of pregnancy. METHODS Seventy-nine patients were randomized into study and control groups. The study group received the intervention in the form of integrated yoga for 4 weeks. Final analysis was done on 30 patients each of study and control group. RESULTS The mean systolic BP declined by 7.43 ± 5.86 mmHg in the study group as compared to 2.50 ± 5.21 mm Hg in the control group (p value 0.002). The mean diastolic BP prior to delivery was 88.00 ± 3.71 mmHg in the study group and 92.20 ± 5.02 mmHg in the control group (p = 0.001). The maternal comfort in labor was significantly higher and the duration of labor significantly reduced in the study group. CONCLUSION Integrated yoga effectively reduced systolic and diastolic blood pressures and increased maternal comfort during labor in hypertensive disorder of pregnancy.",2021,"The maternal comfort in labor was significantly higher and the duration of labor significantly reduced in the study group. ","['30 patients each of study and control group', 'Seventy-nine patients', 'hypertensive disorder of pregnancy']",['integrated yoga'],"['mean diastolic BP prior to delivery', 'duration of labor', 'maternal comfort in labor', 'blood pressure and pregnancy outcome', 'maternal comfort', 'mean systolic BP', 'systolic and diastolic blood pressures']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0566679', 'cui_str': 'Duration of labor'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",79.0,0.0524521,"The maternal comfort in labor was significantly higher and the duration of labor significantly reduced in the study group. ","[{'ForeName': 'Amrita', 'Initials': 'A', 'LastName': 'Makhija', 'Affiliation': 'Department of Obstetrics and Gynecology, Lady Hardinge Medical College, New Delhi, India. Electronic address: amritamakhija@gmail.com.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Khatik', 'Affiliation': 'Department of Obstetrics and Gynecology, Lady Hardinge Medical College, New Delhi, India.'}, {'ForeName': 'Chitra', 'Initials': 'C', 'LastName': 'Raghunandan', 'Affiliation': 'Department of Obstetrics and Gynecology, Lady Hardinge Medical College, New Delhi, India.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101366'] 2684,33769679,The effects of canagliflozin on heart failure and cardiovascular death by baseline participant characteristics: Analysis of the CREDENCE trial.,"Heart failure is prevalent in those with type 2 diabetes and chronic kidney disease, and is associated with significant mortality and morbidity. In the CREDENCE trial, canagliflozin reduced the risk of hospitalization for heart failure (HHF) or cardiovascular (CV) death by 31%. In the current analysis we sought to determine whether the effect of canagliflozin on HHF/CV death differed in subgroups defined by key baseline participant characteristics. Cox regression models were used to estimate hazard ratios and 95% confidence intervals. Canagliflozin was associated with a reduction in the relative risk of HHF/CV death regardless of age, sex, history of heart failure or CV disease, and the use of loop diuretics or glucagon-like peptide-1 receptor agonists (all p interaction  > .114). The absolute benefit of canagliflozin was greater in those at highest baseline risk, such as those with CV disease (50 fewer events/1000 patients treated over 2.5 years vs. 20 fewer events in those without CV disease) or advanced kidney disease (estimated glomerular filtration rate [eGFR] 30-45 mL/min/1.73m 2 : 61 events prevented/1000 patients treated over 2.5 years vs. 23 events in eGFR 60-90 mL/min/1.73m 2 ). Canagliflozin consistently reduces the proportional risk of HHF/CV death across a broad range of subgroups with greater absolute benefits in those at highest baseline risk.",2021,"Canagliflozin was associated with a reduction in the relative risk of HHF/CV death regardless of age, sex, history of HF or CV disease, and the use of loop diuretics or GLP1 receptor agonists (all p interaction >0.114).",[],"['canagliflozin', 'Canagliflozin']","['Heart Failure and Cardiovascular Death', 'proportional risk of HHF/CV death', 'absolute benefit of canagliflozin', 'advanced kidney disease', 'risk of hospitalization for heart failure (HHF) or cardiovascular (CV) death', 'HHF/CV death', 'Heart failure']",[],"[{'cui': 'C2974540', 'cui_str': 'canagliflozin'}]","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205351', 'cui_str': 'Proportional'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}]",,0.19849,"Canagliflozin was associated with a reduction in the relative risk of HHF/CV death regardless of age, sex, history of HF or CV disease, and the use of loop diuretics or GLP1 receptor agonists (all p interaction >0.114).","[{'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Arnott', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jing-Wei', 'Initials': 'JW', 'LastName': 'Li', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Cardiovascular Division, Brigham & Women's Hospital and Baim Institute for Clinical Research, Boston, Massachusetts, USA.""}, {'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'de Zeeuw', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Brendon L', 'Initials': 'BL', 'LastName': 'Neuen', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Charytan', 'Affiliation': 'Nephrology Division, NYU School of Medicine and NYU Langone Medical Center, New York, New York, USA.'}, {'ForeName': 'Anubha', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Huffman', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Gemma A', 'Initials': 'GA', 'LastName': 'Figtree', 'Affiliation': 'Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Bakris', 'Affiliation': 'Department of Medicine, University of Chicago Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Tara I-Hsin', 'Initials': 'TI', 'LastName': 'Chang', 'Affiliation': 'Division of Nephrology, Department of Medicine, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Feng', 'Affiliation': 'Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Rosenthal', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey, USA.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mt Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Meg J', 'Initials': 'MJ', 'LastName': 'Jardine', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14386'] 2685,33779212,Sexually Unexperienced Adolescents Benefit the Most From a Sexual Education Program for Adolescents: A Longitudinal Cluster Randomized Controlled Study.,"Using a longitudinal cluster-randomized controlled design, we examined whether the effects of Competencies for Adolescents with a Healthy Sexuality (COMPAS), an evidence-based sexual health promotion intervention, differ by adolescents' sexual experience. Participants were 699 students aged 14-16, 45.9% were sexually experienced, and assessed in the baseline, posttest, and 12- and 24-month follow-ups. All were recruited from 10 schools that were randomly assigned to the COMPAS program and waiting-list groups (WLG). Using an intent-to-treat analyses, longitudinal changes in psychosocial and behavioral outcomes were explored using generalized estimating equations. Compared to the WLG, COMPAS had a positive impact on six of the seven psychological and behavioral outcomes. Non-sexually experienced reported more favorable HIV-related attitudes, higher condom use intention, lower number of sexual partners, and higher condom use than those sexually experienced. Findings support the importance of implementing sex education actions before adolescents get involved in their first intimate relationships in order to achieve greater impact.",2020,"Non-sexually experienced reported more favorable HIV-related attitudes, higher condom use intention, lower number of sexual partners, and higher condom use than those sexually experienced.","['Sexually Unexperienced Adolescents Benefit the Most From a Sexual Education Program for Adolescents', ""Adolescents with a Healthy Sexuality (COMPAS), an evidence-based sexual health promotion intervention, differ by adolescents' sexual experience"", 'All were recruited from 10 schools', 'Participants were 699 students aged 14-16, 45.9% were sexually experienced, and assessed in the baseline, posttest, and 12- and 24-month follow-ups']","['COMPAS program and waiting-list groups (WLG', 'WLG, COMPAS']",[],"[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],699.0,0.0486886,"Non-sexually experienced reported more favorable HIV-related attitudes, higher condom use intention, lower number of sexual partners, and higher condom use than those sexually experienced.","[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Morales', 'Affiliation': 'Miguel Hernández University, Elche, Spain.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Orgilés', 'Affiliation': 'Miguel Hernández University, Elche, Spain.'}, {'ForeName': 'José P', 'Initials': 'JP', 'LastName': 'Espada', 'Affiliation': 'Miguel Hernández University, Elche, Spain.'}]",AIDS education and prevention : official publication of the International Society for AIDS Education,['10.1521/aeap.2020.32.6.493'] 2686,33778462,Case study of a critically ill person with COVID-19 on ECMO successfully treated with leronlimab.,"The number of confirmed cases of infection with SARS-CoV-2, the virus causing Coronavirus disease 2019 (COVID-19), continues to increase and is associated with substantial morbidity and mortality in virtually every country in the world. Although in the long-term mass vaccinations remains the most promising approach to control the pandemic, evidence suggests that new variants of the virus have emerged that may be able to evade the immune responses triggered by current vaccines. Therefore despite the recent approval of a number of SARS-CoV-2 vaccines there remains considerable urgency for effective treatments for COVID-19. Severe-to-critical COVID-19 has been shown to be associated with a dysregulated host immune response to SARS-CoV-2 with elevated levels of C-C chemokine receptor type 5 (CCR5) ligands including chemokine C-C ligands 3, 4, 5, as well as interleukins 6 and 10. Leronlimab, a CCR5-specific humanised IgG4 monoclonal antibody originally developed for the treatment of HIV has been studied for the treatment of COVID-19. In the TEMPEST trial which compared leronlimab to placebo in subjects with mild-to-moderate COVID-19, a post hoc analysis showed that leronlimab led to improvements from baseline in National Early Warning Score 2 (NEWS2) at Day 14 in the sub-set of people with more severe disease. Data has also been released on a further ongoing, randomized, placebo-controlled phase 3 registrational trial of leronlimab in 394 people with severe-to-critical COVID-19. The results show that Day 28 mortality was reduced (P ​= ​0.0319) in the subset of participants receiving leronlimab plus other pre-specified commonly used COVID-19 treatments including dexamethasone administered as part of their standard of care (SOC) compared to participants receiving placebo plus other pre-specified commonly used COVID-19 treatments including dexamethasone as part of their SOC. Several cases have recently been reported demonstrated that treatment with leronlimab restores immune function and achieves clinical improvement in people with critical COVID-19. Here we report on a further case of a critically ill person who was treated with leronlimab. This person had been on extracorporeal membrane oxygenation (ECMO) for an extended period of time before receiving 4 doses of leronlimab. The male subject received his first dose of leronlimab on Day 79 of hospitalization he was weaned off ECMO by Day 84 and discharged from the ECMO intensive care unit on Day 91.",2021,The results show that Day 28 mortality was reduced (P=0.0319) in the subset of participants receiving leronlimab plus other pre-specified commonly used COVID-19 treatments including dexamethasone administered as part of their standard of care (SOC) compared to participants receiving placebo plus other pre-specified commonly used COVID-19 treatments including dexamethasone as part of their SOC.,"['critically ill person who was treated with leronlimab', '394 people with severe-to-critical COVID-19', 'critically ill person with COVID-19 on ECMO successfully treated with leronlimab', 'subjects with mild-to-moderate COVID-19']","['dexamethasone', 'placebo', 'extracorporeal membrane oxygenation (ECMO']",['Day 28 mortality'],"[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",394.0,0.169732,The results show that Day 28 mortality was reduced (P=0.0319) in the subset of participants receiving leronlimab plus other pre-specified commonly used COVID-19 treatments including dexamethasone administered as part of their standard of care (SOC) compared to participants receiving placebo plus other pre-specified commonly used COVID-19 treatments including dexamethasone as part of their SOC.,"[{'ForeName': 'Sohier', 'Initials': 'S', 'LastName': 'Elneil', 'Affiliation': 'University College London, National Hospital for Neurology and Neurosurgery, London, UK.'}, {'ForeName': 'Jacob P', 'Initials': 'JP', 'LastName': 'Lalezari', 'Affiliation': 'Quest Clinical Research, 2300 Sutter Street, Suite #202 & 208, San Francisco, CA, 94115, USA.'}, {'ForeName': 'Nader Z', 'Initials': 'NZ', 'LastName': 'Pourhassan', 'Affiliation': 'CytoDyn, 1111 Main Street, Suite 660, Vancouver, WA, 98660, USA.'}]",Journal of translational autoimmunity,['10.1016/j.jtauto.2021.100097'] 2687,33765667,Investigation of oral malodor prevention by dentifrices as measured by VSC reduction.,"The oral malodor reduction efficacy of dentifrices containing stannous fluoride (SnF 2 ) or zinc plus arginine (Zn/Arg) was evaluated using a halimeter to measure volatile sulfur compounds (VSCs) in two randomized, controlled, single-blind, cross-over pilot clinical trials. Study 1 ( N = 16) had five 1100 ppm F dentifrices and five treatment periods: negative control (NC): 0.243% sodium fluoride (NaF); SnF 2 A: 0.454% SnF 2 + pyrophosphate; SnF 2 B: 0.454% SnF 2 + sodium hexametaphosphate; SnF 2 C: 0.454% SnF 2 + citrate; and SnF 2 D: experimental 0.454% SnF 2 with increased bioavailable Sn. Study 2 ( N = 16) had four 1450 ppm F dentifrices and four treatment periods: NC: 0.1% NaF + 0.76% sodium monofluorophosphate; Zn/Arg: NaF + zinc + arginine; SnF 2 E: 0.454% SnF 2 + 0.078% NaF + sodium hexametaphosphate; SnF 2 F: 0.454% SnF 2 + 0.078% NaF + citrate. Each period took 96 h; baseline (day 0) morning to day 4 morning. Subjects brushed 2 x /day with the treatment dentifrice. VSC levels were measured in the morning, prior to morning brushing, on days 0 and 4. Changes in VSC scores from day 0 to day 4 were assessed using a mixed-model analysis of covariance for cross-over studies. In study 1, SnF 2 dentifrices B, C and D showed statistically significant reductions (31.3%, 24.8%, 34%, respectively) in VSC scores versus baseline ( p < 0.001); the benefits of these treatments versus NC and SnF 2 dentifrice A were statistically significant ( p ⩽ 0.001). In study 2, SnF 2 dentifrices E and F showed statistically significant reductions (31.2%, 22.1%, respectively) in VSC scores versus baseline ( p ⩽ 0.010); the benefits of these treatments versus NC and the Zn/Arg dentifrice were statistically significant ( p ⩽ 0.035). The Zn/Arg dentifrice showed a significant increase of 35.2% ( p < 0.001) in VSC scores versus baseline. These studies demonstrated that SnF 2 dentifrices can provide significant oral malodor reductions, but the benefit is formulation dependent. The presence of SnF 2 is not sufficient to ensure efficacy. The Zn/Arg dentifrice increased VSC levels, indicating greater malodor. Clinical Trial Numbers : 20190429 and 20191028.",2021,The Zn/Arg dentifrice showed a significant increase of 35.2% (p<0.001) in VSC scores versus baseline.,[],"['ppm F dentifrices and five treatment periods: Negative Control (NC): 0.243% sodium fluoride (NaF', 'SnF2 dentifrices', 'SnF2 dentifrice', 'dentifrices containing stannous fluoride (SnF2) or zinc plus arginine', 'NaF+0.76% sodium monofluorophosphate; Zn/Arg: NaF+zinc+arginine; SnF2 E', 'SnF2+0.078% NaF +sodium hexametaphosphate; SnF2 F']","['VSC levels', 'VSC scores']",[],"[{'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0038143', 'cui_str': 'Stannous Fluoride'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0142890', 'cui_str': 'sodium monofluorophosphate'}, {'cui': 'C1639518', 'cui_str': '% negative control'}, {'cui': 'C0074759', 'cui_str': 'sodium polymetaphosphate'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0790197,The Zn/Arg dentifrice showed a significant increase of 35.2% (p<0.001) in VSC scores versus baseline.,"[{'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Zsiska', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, United States of America.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Schneiderman', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, United States of America.'}, {'ForeName': 'Yingkun', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, United States of America.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Farrell', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, United States of America.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Grender', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, United States of America.'}]",Journal of breath research,['10.1088/1752-7163/abf209'] 2688,33765458,A Modified Pressure Dressing to Avoid Severe Bleeding After Circumcision With a Disposable Circumcision Suture Device and a Discussion on the Mechanism of Bleeding With the Disposable Circumcision Suture Device.,"INTRODUCTION A novel type of a disposable circumcision suture device (DCSD) has been proved to be effective and safe; however, a few cases of severe bleeding took place after circumcisions. AIM To evaluate the effectiveness of a modified double-layer pressure dressing to avoid severe bleeding after circumcision with the DCSD, in our department in a prospective randomized controlled study, and discuss the mechanism of bleeding with DCSD. METHODS Patients with redundant foreskin or phimosis were included between September 2018 and November 2019 and divided into 2 groups: In group A, the conventional pressure dressing was performed; in group B, an modified double-layer pressure dressing was performed. MAIN OUTCOME MEASURE The main outcomes and complications (surgical time, incidence of glans ischemia, severe bleeding rate, infection rate, pain level, total cost, and overall satisfaction) were collected and analyzed. RESULTS A total of 624 patients were recruited for this study. There was no difference in the average age and body mass index between 2 groups. No patient suffered obvious glans ischemia. In group B, lower pain level, lower incidences of severe bleeding, and better satisfaction were recorded. CONCLUSION The mechanism of bleeding with the DCSD was discussed in this study, and the modified pressure dressing was proved effective, safe, and easy to perform. W Jiang, J-li Fu, W-l Guo, et al. A Modified Pressure Dressing to Avoid Severe Bleeding After Circumcision With a Disposable Circumcision Suture Device and a Discussion on the Mechanism of Bleeding With the Disposable Circumcision Suture Device. Sex Med 2021;9:100288.",2021,"In group B, lower pain level, lower incidences of severe bleeding, and better satisfaction were recorded. ","['Patients with redundant foreskin or phimosis were included between September 2018 and November 2019', 'A total of 624 patients were recruited for this study']","['Modified Pressure Dressing', 'modified double-layer pressure dressing was performed', 'conventional pressure dressing', 'disposable circumcision suture device (DCSD', 'modified double-layer pressure dressing']","['lower pain level, lower incidences of severe bleeding, and better satisfaction', 'complications (surgical time, incidence of glans ischemia, severe bleeding rate, infection rate, pain level, total cost, and overall satisfaction', 'average age and body mass index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0345325', 'cui_str': 'Redundant prepuce'}, {'cui': 'C0031538', 'cui_str': 'Phimosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1289828', 'cui_str': 'Pressure dressing'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",624.0,0.0507902,"In group B, lower pain level, lower incidences of severe bleeding, and better satisfaction were recorded. ","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': ""Department of Urology, Dongying People's Hospital, Dongying, China. Electronic address: jwmnwk@163.com.""}, {'ForeName': 'Jia-Li', 'Initials': 'JL', 'LastName': 'Fu', 'Affiliation': ""Department of Urology, Dongying People's Hospital, Dongying, China.""}, {'ForeName': 'Wen-Liang', 'Initials': 'WL', 'LastName': 'Guo', 'Affiliation': 'Surgery Department, Health Center of Qingzhou Economic Development Zone, Qingzhou, China.'}, {'ForeName': 'Zai-Chun', 'Initials': 'ZC', 'LastName': 'Yan', 'Affiliation': ""Department of Urology, Dongying People's Hospital, Dongying, China.""}, {'ForeName': 'Ru-Qiang', 'Initials': 'RQ', 'LastName': 'Zheng', 'Affiliation': ""Department of Urology, Dongying People's Hospital, Dongying, China.""}, {'ForeName': 'Ji-Ru', 'Initials': 'JR', 'LastName': 'Lu', 'Affiliation': ""Department of Urology, Dongying People's Hospital, Dongying, China.""}, {'ForeName': 'Xiao-Dong', 'Initials': 'XD', 'LastName': 'Lai', 'Affiliation': ""Department of Urology, Dongying People's Hospital, Dongying, China.""}]",Sexual medicine,['10.1016/j.esxm.2020.100288'] 2689,33769666,The beneficial short-term effects of a high-protein/low-carbohydrate diet on glycaemic control assessed by continuous glucose monitoring in patients with type 1 diabetes.,"AIM To compare the effects of three different but isocaloric dietary patterns, high-protein/low-carbohydrate (HPD) with 20% of calories as carbohydrates, Mediterranean/low glycaemic index (MED) with 40% carbohydrates, and a reference diet (REF) with 50% carbohydrates, in patients with type 1 diabetes (T1D). MATERIALS AND METHODS In a randomized crossover study, 15 patients with T1D were assigned to the three dietary patterns for three separate weeks, with 7-day washout periods in between. Continuous glucose monitoring was applied during the intervention periods. The primary outcome was glycaemic control, as measured by the percentage of time patients spent within the euglycaemic range (TIR 70-140   mg/d l ). Other key glycaemic metrics were also investigated as secondary outcomes. RESULTS TIR 70-140 was not statistically different between HPD, MED and REF (p = .105). Pairwise analysis revealed a statistically significant difference between HPD and REF at the .05 level, which was not retained after applying Bonferroni correction (54.87% ± 14.11% vs. 48.33% ± 13.72%; p = .018). During the HPD period, 11 out of 15 participants spent more time within TIR 70-140 compared with either the REF or MED. The HPD performed significantly better than the REF in terms of TIR 70-180 (74.33% ± 12.85% vs. 67.53% ± 12.73%; p = .012), glycaemic variability (coefficient of variation: 36.18% ± 9.30% vs. 41.48% ± 8.69%; p = .016) and time spent in the hypoglycaemic range (TBR 70   mg/d l ; median: 12, IQR: 16 vs. median: 14, IQR: 20; p = .007), whereas no statistically significant differences were observed between MED and HPD or REF. CONCLUSIONS Compared with REF and MED, an HPD plan may have a positive impact on glycaemic control in patients with T1D. During the HPD, patients spent a shorter time in hypoglycaemia and exhibited lower glycaemic variability.",2021,"RESULTS TIR 70-140 was not statistically different between the three diets (p=0.105).","['patients with type 1 diabetes (T1D', 'patients with T1D', 'patients with type 1 diabetes', '15 patients with T1D']","['isocaloric dietary patterns (high-protein/low-carbohydrate (HPD) with 20% calories as carbohydrates, Mediterranean/low glycemic index (MED) with 40% carbohydrates and reference diet (REF) with 50% carbohydrates', 'Continuous glucose monitoring (CGM', 'high-protein/low-carbohydrate diet']","['shorter time in hypoglycemia', 'glycemic variability', 'time spent in the hypoglycemic range', 'glycemic control, as measured by the percentage of time patients spent within the euglycemic range', 'HPD and REF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0259836', 'cui_str': 'Carbohydrate restricted diet'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0121300', 'cui_str': 'Hematoporphyrin D'}]",15.0,0.0253487,"RESULTS TIR 70-140 was not statistically different between the three diets (p=0.105).","[{'ForeName': 'Charilaos', 'Initials': 'C', 'LastName': 'Dimosthenopoulos', 'Affiliation': 'Department of Clinical Nutrition, Laiko General Hospital, Athens, Greece.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Liatis', 'Affiliation': 'First Department of Propaedeutic Internal Medicine, Medical School, National and Kapodistrian University of Athens, Diabetes Centre, Laiko General Hospital, Athens, Greece.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Kourpas', 'Affiliation': 'Department of Accounting and Management Information Systems, University of Delaware, Newark, Delaware, USA.'}, {'ForeName': 'Elpida', 'Initials': 'E', 'LastName': 'Athanasopoulou', 'Affiliation': 'First Department of Propaedeutic Internal Medicine, Medical School, National and Kapodistrian University of Athens, Diabetes Centre, Laiko General Hospital, Athens, Greece.'}, {'ForeName': 'Stamatina', 'Initials': 'S', 'LastName': 'Driva', 'Affiliation': 'First Department of Propaedeutic Internal Medicine, Medical School, National and Kapodistrian University of Athens, Diabetes Centre, Laiko General Hospital, Athens, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Makrilakis', 'Affiliation': 'First Department of Propaedeutic Internal Medicine, Medical School, National and Kapodistrian University of Athens, Diabetes Centre, Laiko General Hospital, Athens, Greece.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kokkinos', 'Affiliation': 'First Department of Propaedeutic Internal Medicine, Medical School, National and Kapodistrian University of Athens, Diabetes Centre, Laiko General Hospital, Athens, Greece.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14390'] 2690,33769656,"Henagliflozin as add-on therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin: A multicentre, randomized, double-blind, placebo-controlled, phase 3 trial.","AIM To evaluate the efficacy and safety of henagliflozin in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin. MATERIAL AND METHODS This multicentre phase 3 trial included a 24-week randomized, double-blind, placebo-controlled period, followed by a 28-week extension period. Patients with a glycated haemoglobin (HbA1c) level of 7.0% (53 mmol/mol) to 10.5% (91 mmol/mol) were randomized and treated with once-daily placebo (n = 161), henagliflozin 5 mg (n = 162), or henagliflozin 10 mg (n = 160). After 24 weeks, patients on placebo were switched to 5 mg or 10 mg henagliflozin for the additional 28-week treatment, and patients on henagliflozin during 24-week treatment period maintained this initial therapy. The primary endpoint was change in HbA1c from baseline to Week 24. RESULTS At Week 24, the least squares mean HbA1c changes versus placebo from baseline were - 0.76% (-8.3 mmol/mol) and - 0.80% (-8.7 mmol/mol) for henagliflozin 5 and 10 mg, respectively (all P < 0.0001). Compared with the placebo group, both doses of henagliflozin lowered fasting plasma glucose, 2-hour postprandial plasma glucose, body weight and blood pressure, and increased the proportions of patients achieving HbA1c <7.0% (53 mmol/mol) at Week 24. The trends in these improvements were sustained over an additional 28 weeks. Slightly higher proportions of ketosis and presence of urine ketone bodies were observed in patients treated with henagliflozin compared to placebo at Week 24. No diabetic ketoacidosis or episodes of severe hypoglycaemia were reported. CONCLUSIONS Henagliflozin 5 mg or 10 mg as add-on therapy to metformin provided a new therapeutic option for the treatment of T2DM patients who have inadequate glycaemic control with metformin alone, and was generally well tolerated.",2021,"Compared with the Placebo group, both doses of henagliflozin lowered fasting plasma glucose, 2-hour postprandial plasma glucose, body weight, blood pressure and increased the proportions of patients achieving HbA1c <7.0% at Week 24.","['patients with type 2 diabetes inadequately controlled with', 'patients with Type 2 diabetes mellitus (T2DM', 'Patients with a hemoglobin A1c (HbA1c) of 7.0%-10.5']","['Henagliflozin 5 mg (n=162), or Henagliflozin', 'henagliflozin', 'metformin', 'placebo', 'Henagliflozin', 'Placebo']","['tolerated', 'efficacy and safety', 'change in HbA1c', 'diabetic ketoacidosis or episode of severe hypoglycemia', 'fasting plasma glucose, 2-hour postprandial plasma glucose, body weight, blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517521', 'cui_str': '10.5'}]","[{'cui': 'C4309480', 'cui_str': 'henagliflozin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",,0.29962,"Compared with the Placebo group, both doses of henagliflozin lowered fasting plasma glucose, 2-hour postprandial plasma glucose, body weight, blood pressure and increased the proportions of patients achieving HbA1c <7.0% at Week 24.","[{'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Weng', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, China.'}, {'ForeName': 'Longyi', 'Initials': 'L', 'LastName': 'Zeng', 'Affiliation': 'Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yuwei', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Huaxi Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Shen', 'Initials': 'S', 'LastName': 'Qu', 'Affiliation': ""Shanghai 10th People's Hospital, Shanghai, China.""}, {'ForeName': 'Xueying', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Jinzhou Central Hospital, Jinzhou, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Yuncheng Central Hospital, Taiyuan, China.'}, {'ForeName': 'Liujun', 'Initials': 'L', 'LastName': 'Fu', 'Affiliation': 'First Affiliated Hospital of Henan University of Science and Technology, Luoyang, China.'}, {'ForeName': 'Boqing', 'Initials': 'B', 'LastName': 'Ma', 'Affiliation': 'Hebei General Hospital, Shijiazhuang, China.'}, {'ForeName': 'Shandong', 'Initials': 'S', 'LastName': 'Ye', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, China.'}, {'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Huadong Hospital Affiliated to Fudan University, Shanghai, China.'}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': ""First Affiliated Huai'an Hospital of Nanjing Medical University, Huai'an, China.""}, {'ForeName': 'Zhiwen', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Shanghai Xuhui District Central Hospital, Shanghai, China.'}, {'ForeName': 'Daoxiong', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Hainan General Hospital, Haikou, China.'}, {'ForeName': 'Zhifeng', 'Initials': 'Z', 'LastName': 'Cheng', 'Affiliation': 'Fourth Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Jiangsu Hengrui Medicine Co., Ltd, Shanghai, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Jiangsu Hengrui Medicine Co., Ltd, Shanghai, China.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': 'Jiangsu Hengrui Medicine Co., Ltd, Shanghai, China.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14389'] 2691,33769299,"System Architecture for ""Support Through Mobile Messaging and Digital Health Technology for Diabetes"" (SuMMiT-D): Design and Performance in Pilot and Randomized Controlled Feasibility Studies.","BACKGROUND Diabetes is a highly prevalent long-term condition with high morbidity and mortality rates. People with diabetes commonly worry about their diabetes medicines and do not always take them regularly as prescribed. This can lead to poor diabetes control. The Support Through Mobile Messaging and Digital Health Technology for Diabetes (SuMMiT-D) study aims to deliver brief messages as tailored interventions to support people with type 2 diabetes in better use of their diabetes medicines and to improve treatment adherence and health outcomes. OBJECTIVE This paper describes the overall architecture of a tailored intervention delivery system used in the pilot and randomized controlled feasibility studies of SuMMiT-D and reports its performance. METHODS The SuMMiT-D system includes several platforms and resources to recruit participants and deliver messages as tailored interventions. Its core component is called the clinical system and is responsible for interacting with the participants by receiving and sending SMS text messages from and to them. The personalization and tailoring of brief messages for each participant is based on a list of built-in commands that they can use. RESULTS For the pilot study, a total of 48 participants were recruited; they had a median age of 64 years (first quartile, third quartile [Q 1 , Q 3 : 54.5, 69]). For the feasibility study, a total of 209 participants were recruited and randomly assigned to either the control or intervention group; they had a median age of 65 years (Q 1 , Q 3 : 56, 71), with 41.1% (86/209) being female. The participants used the SuMMiT-D system for up to 6 months (26 weeks) and had a wide range of different interactions with the SuMMiT-D system while tailored interventions were being delivered. For both studies, we had low withdrawal rates: only 4.2% and 5.3% for the pilot and feasibility studies, respectively. CONCLUSIONS A system was developed to successfully deliver brief messages as tailored health interventions to more than 250 people with type 2 diabetes via SMS text messages. On the basis of the low withdrawal rates and positive feedback received, it can be inferred that the SuMMiT-D system is robust, user-friendly, useful, and positive for most participants. From the two studies, we found that online recruitment was more efficient than recruitment via postal mail; a regular SMS text reminder (eg, every 4 weeks) can potentially increase the participants' interactions with the system. TRIAL REGISTRATION ISRCTN Registry ISRCTN13404264; http://www.isrctn.com/ISRCTN13404264.",2021,Its core component is called the clinical system and is responsible for interacting with the participants by receiving and sending SMS text messages from and to them.,"['People with diabetes commonly worry about their diabetes medicines', '250 people with type 2 diabetes via SMS text messages', '209 participants', '48 participants were recruited; they had a median age of 64 years (first quartile, third quartile ']",['SuMMiT-D'],['low withdrawal rates'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0205437', 'cui_str': 'Third'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0752189', 'cui_str': 'Health Care Technology'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}]",48.0,0.0994746,Its core component is called the clinical system and is responsible for interacting with the participants by receiving and sending SMS text messages from and to them.,"[{'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Chi', 'Affiliation': 'Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Carmelo', 'Initials': 'C', 'LastName': 'Velardo', 'Affiliation': 'Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Allen', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Robinson', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Evgenia', 'Initials': 'E', 'LastName': 'Riga', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Judge', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Tarassenko', 'Affiliation': 'Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Farmer', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}]",JMIR formative research,['10.2196/18460'] 2692,33768619,Nitazoxanide versus rifaximin in preventing the recurrence of hepatic encephalopathy: A randomized double-blind controlled trial.,"BACKGROUND/PURPOSE Hepatic encephalopathy (HE) is a neuropsychiatric complication of liver cirrhosis. HE is associated with poor survival and detrimental effects on quality of life (QOL). The drawbacks of the long-term use of rifaximin in HE necessitates searching for alternative therapies. In this context, our study aimed at evaluating the safety and efficacy of nitazoxanide (NTZ) as compared to rifaximin (RFX) in preventing the recurrence of HE and assessing its impact on QOL. PATIENTS AND METHODS This prospective, randomized, double-blind controlled study included 60 patients who were randomly assigned to receive either rifaximin 550 mg twice daily (group 1; n = 30) or nitazoxanide 500 mg twice daily (group 2; n = 30) for 24 weeks. During the study period, the patients' neurological symptoms, mental status, and performance were monitored. The serum levels of HE triggers (ammonia, TNF-α, and octopamine) were assessed. The patients' health-related quality of life was also evaluated. RESULTS Six months after treatment, patients on NTZ therapy showed a statistically significant improvement in CHESS score and mental status. NTZ provided 136 days of remission vs 67 days of remission for patients on RFX (P 1  = .0001) and significant reduction in Child score (P 1  = .018). Additionally, NTZ showed a statistically significant decrease in serum ammonia, TNF-α, and octopamine levels as compared to rifaximin. Regarding QOL, NTZ group showed an improvement in total Chronic Liver Disease Questionnaire (CLDQ) score. Both groups experienced minor controllable side effects. CONCLUSION Nitazoxanide may represent a suitable and safe alternative therapy to rifaximin in preventing the recurrence of hepatic encephalopathy.",2021,"Additionally, NTZ showed a statistically significant decrease in serum ammonia, TNF-α, and octopamine levels as compared to rifaximin.","['Hepatic Encephalopathy', 'sixty patients']","['Nitazoxanide\xa0versus Rifaximin', 'rifaximin 550 mg twice daily', 'rifaximin (RFX', 'nitazoxanide', 'Nitazoxanide', 'nitazoxanide (NTZ', 'NTZ therapy', 'NTZ']","['quality of life (QOL', 'serum levels\xa0of HE triggers (ammonia, TNF-α, and octopamine', 'quality of life', 'Child score', 'safety and efficacy', 'serum ammonia, TNF-α, and octopamine levels', 'total Chronic Liver Disease Questionnaire (CLDQ) score', 'neurological symptoms, mental status and performance', 'CHESS score and\xa0mental status']","[{'cui': 'C0019151', 'cui_str': 'Hepatic encephalopathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0068788', 'cui_str': 'nitazoxanide'}, {'cui': 'C0073374', 'cui_str': 'rifaximin'}, {'cui': 'C2710454', 'cui_str': 'rifaximin 550 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019151', 'cui_str': 'Hepatic encephalopathy'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0002607', 'cui_str': 'Ammonia'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0028403', 'cui_str': 'Octopamine'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0341439', 'cui_str': 'Chronic liver disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0235031', 'cui_str': 'Neurological symptom'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}]",60.0,0.120798,"Additionally, NTZ showed a statistically significant decrease in serum ammonia, TNF-α, and octopamine levels as compared to rifaximin.","[{'ForeName': 'Khadija A M', 'Initials': 'KAM', 'LastName': 'Glal', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Sherief M', 'Initials': 'SM', 'LastName': 'Abd-Elsalam', 'Affiliation': 'Department of Tropical Medicine and Infectious Diseases, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Tarek M', 'Initials': 'TM', 'LastName': 'Mostafa', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Tanta University, Tanta, Egypt.'}]",Journal of hepato-biliary-pancreatic sciences,['10.1002/jhbp.947'] 2693,33768599,Virtual optimization of guideline-directed medical therapy in hospitalized patients with heart failure with reduced ejection fraction: the IMPLEMENT-HF pilot study.,"AIMS Implementation of guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF) remains incomplete. Non-cardiovascular hospitalization may present opportunities for GDMT optimization. We assessed the efficacy and durability of a virtual, multidisciplinary 'GDMT Team' on medical therapy prescription for HFrEF. METHODS AND RESULTS Consecutive hospitalizations in patients with HFrEF (ejection fraction ≤40%) were prospectively identified from 3 February to 1 March 2020 (usual care group) and 2 March to 28 August 2020 (intervention group). Patients with critical illness, de novo heart failure, and systolic blood pressure <90 mmHg in the preceeding 24 hs prior to enrollment were excluded. In the intervention group, a pharmacist-physician GDMT Team provided optimization suggestions to treating teams based on an evidence-based algorithm. The primary outcome was a GDMT optimization score, the sum of positive (+1 for new initiations or up-titrations) and negative therapeutic changes (-1 for discontinuations or down-titrations) at hospital discharge. Serious in-hospital safety events were assessed. Among 278 consecutive encounters with HFrEF, 118 met eligibility criteria; 29 (25%) received usual care and 89 (75%) received the GDMT Team intervention. Among usual care encounters, there were no changes in GDMT prescription during hospitalization. In the intervention group, β-blocker (72% to 88%; P = 0.01), angiotensin receptor-neprilysin inhibitor (6% to 17%; P = 0.03), mineralocorticoid receptor antagonist (16% to 29%; P = 0.05), and triple therapy (9% to 26%; P < 0.01) prescriptions increased during hospitalization. After adjustment for clinically relevant covariates, the GDMT Team was associated with an increase in GDMT optimization score (+0.58; 95% confidence interval +0.09 to +1.07; P = 0.02). There were no serious in-hospital adverse events. CONCLUSIONS Non-cardiovascular hospitalizations are a potentially safe and effective setting for GDMT optimization. A virtual GDMT Team was associated with improved heart failure therapeutic optimization. This implementation strategy warrants testing in a prospective randomized controlled trial.",2021,"In the intervention group, β-blocker (72% to 88%; P=0.01), ARNI (6% to 17%; P=0.03), MRA (16% to 29%; P=0.05), and triple therapy (9% to 26%; P<0.01) prescriptions increased during hospitalization.","['Consecutive hospitalizations in patients with HFrEF≤40% were prospectively identified from February 3 to March 1, 2020 (usual care group) and March 2 to August 28, 2020 (intervention group', 'Hospitalized Patients with Heart Failure with Reduced Ejection Fraction', 'Patients with critical illness, de-novo HF, and SBP<90mmHg were excluded', '278 consecutive encounters with HFrEF, 118 met eligibility criteria; 29 (25%) received usual care and 89 (75%) received the']","['HFrEF', 'Virtual Optimization of Guideline-Directed Medical Therapy', 'GDMT Team intervention']","['GDMT optimization score, the net of positive (+1 for new initiations or up-titrations) & negative therapeutic changes (-1 for discontinuations or down-titrations) at hospital discharge', 'GDMT optimization score', 'hospital adverse events', 'ARNI', 'β-blocker', 'efficacy and durability', 'MRA']","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0243032', 'cui_str': 'Magnetic resonance imaging (MRI) of vessels'}]",,0.0314161,"In the intervention group, β-blocker (72% to 88%; P=0.01), ARNI (6% to 17%; P=0.03), MRA (16% to 29%; P=0.05), and triple therapy (9% to 26%; P<0.01) prescriptions increased during hospitalization.","[{'ForeName': 'Ankeet S', 'Initials': 'AS', 'LastName': 'Bhatt', 'Affiliation': ""Division of Cardiology, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Anubodh S', 'Initials': 'AS', 'LastName': 'Varshney', 'Affiliation': ""Division of Cardiology, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Mahan', 'Initials': 'M', 'LastName': 'Nekoui', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Alea', 'Initials': 'A', 'LastName': 'Moscone', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Cunningham', 'Affiliation': ""Division of Cardiology, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Karola S', 'Initials': 'KS', 'LastName': 'Jering', 'Affiliation': ""Division of Cardiology, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Parth N', 'Initials': 'PN', 'LastName': 'Patel', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Sinnenberg', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Bernier', 'Affiliation': ""Department of Pharmacy, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Leo F', 'Initials': 'LF', 'LastName': 'Buckley', 'Affiliation': ""Department of Pharmacy, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Bryan M', 'Initials': 'BM', 'LastName': 'Cook', 'Affiliation': ""Department of Pharmacy, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Dempsey', 'Affiliation': ""Department of Pharmacy, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Kelly', 'Affiliation': ""Department of Pharmacy, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Knowles', 'Affiliation': ""Department of Pharmacy, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Lupi', 'Affiliation': ""Department of Pharmacy, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Rhynn', 'Initials': 'R', 'LastName': 'Malloy', 'Affiliation': ""Department of Pharmacy, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Lina S', 'Initials': 'LS', 'LastName': 'Matta', 'Affiliation': ""Department of Pharmacy, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Megan N', 'Initials': 'MN', 'LastName': 'Rhoten', 'Affiliation': ""Department of Pharmacy, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Krishan', 'Initials': 'K', 'LastName': 'Sharma', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Snyder', 'Affiliation': 'Brown University, Providence, RI, USA.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Ting', 'Affiliation': ""Department of Pharmacy, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'McElrath', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Mary G', 'Initials': 'MG', 'LastName': 'Amato', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Alobaidly', 'Affiliation': ""Department of Quality and Safety, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Ulbricht', 'Affiliation': 'Massachusetts College of Pharmacy and Health Sciences, Boston, MA, USA.'}, {'ForeName': 'Niteesh K', 'Initials': 'NK', 'LastName': 'Choudhry', 'Affiliation': ""Center for Healthcare Delivery Sciences, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Dale S', 'Initials': 'DS', 'LastName': 'Adler', 'Affiliation': ""Division of Cardiology, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Division of Cardiology, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}]",European journal of heart failure,['10.1002/ejhf.2163'] 2694,33768368,Can Pharmacokinetic Studies Assess the Pulmonary Fate of Dry Powder Inhaler Formulations of Fluticasone Propionate?,"In the context of streamlining generic approval, this study assessed whether pharmacokinetics (PK) could elucidate the pulmonary fate of orally inhaled drug products (OIDPs). Three fluticasone propionate (FP) dry powder inhaler (DPI) formulations (A-4.5, B-3.8, and C-3.7), differing only in type and composition of lactose fines, exhibited median mass aerodynamic diameter (MMAD) of 4.5 μm (A-4.5), 3.8 μm (B-3.8), and 3.7 μm (C-3.7) and varied in dissolution rates (A-4.5 slower than B-3.8 and C-3.7). In vitro total lung dose (TLD in vitro ) was determined as the average dose passing through three anatomical mouth-throat (MT) models and yielded dose normalization factors (DNF) for each DPI formulation X (DNF x = TLD in vitro,x /TLD in vitro,A-4.5 ). The DNF was 1.00 for A-4.5, 1.32 for B-3.8, and 1.21 for C-3.7. Systemic PK after inhalation of 500 μg FP was assessed in a randomized, double-blind, four-way crossover study in 24 healthy volunteers. Peak concentrations (C max ) of A-4.5 relative to those of B-3.8 or C-3.7 lacked bioequivalence without or with dose normalization. The area under the curve (AUC 0-Inf ) was bio-IN-equivalent before dose normalization and bioequivalent after dose normalization. Thus, PK could detect differences in pulmonary available dose (AUC 0-Inf ) and residence time (dose-normalized C max ). The differences in dose-normalized C max could not be explained by differences in in vitro dissolution. This might suggest that C max differences may indicate differences in regional lung deposition. Overall this study supports the use of PK studies to provide relevant information on the pulmonary performance characteristics (i.e., available dose, residence time, and regional lung deposition).",2021,Peak concentrations (C max ) of A-4.5 relative to those of B-3.8 or C-3.7 lacked bioequivalence without or with dose normalization.,['24 healthy volunteers'],"['fluticasone propionate (FP) dry powder inhaler (DPI) formulations', 'Fluticasone Propionate']","['median mass aerodynamic diameter (MMAD', 'regional lung deposition', 'Peak concentrations (C max ', 'dissolution rates']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C1967611', 'cui_str': 'Dry powder inhaler'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",24.0,0.149014,Peak concentrations (C max ) of A-4.5 relative to those of B-3.8 or C-3.7 lacked bioequivalence without or with dose normalization.,"[{'ForeName': 'Günther', 'Initials': 'G', 'LastName': 'Hochhaus', 'Affiliation': 'Department of Pharmaceutics, College of Pharmacy, University of Florida, 1345 Center Drive, Gainesville, Florida, 32610, USA. hochhaus@ufl.edu.'}, {'ForeName': 'Mong-Jen', 'Initials': 'MJ', 'LastName': 'Chen', 'Affiliation': 'Department of Pharmaceutics, College of Pharmacy, University of Florida, 1345 Center Drive, Gainesville, Florida, 32610, USA.'}, {'ForeName': 'Abhinav', 'Initials': 'A', 'LastName': 'Kurumaddali', 'Affiliation': 'Department of Pharmaceutics, College of Pharmacy, University of Florida, 1345 Center Drive, Gainesville, Florida, 32610, USA.'}, {'ForeName': 'Uta', 'Initials': 'U', 'LastName': 'Schilling', 'Affiliation': 'Department of Pharmaceutics, College of Pharmacy, University of Florida, 1345 Center Drive, Gainesville, Florida, 32610, USA.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Jiao', 'Affiliation': 'Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, 6550 Sanger Road, Gainesville, Florida, 32827-7445, USA.'}, {'ForeName': 'Stefanie K', 'Initials': 'SK', 'LastName': 'Drescher', 'Affiliation': 'Department of Pharmaceutics, College of Pharmacy, University of Florida, 1345 Center Drive, Gainesville, Florida, 32610, USA.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Amini', 'Affiliation': 'Department of Pharmaceutics, College of Pharmacy, University of Florida, 1345 Center Drive, Gainesville, Florida, 32610, USA.'}, {'ForeName': 'Bhargava', 'Initials': 'B', 'LastName': 'Kandala', 'Affiliation': 'Department of Pharmaceutics, College of Pharmacy, University of Florida, 1345 Center Drive, Gainesville, Florida, 32610, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Tabulov', 'Affiliation': 'Department of Pharmaceutics, College of Pharmacy, University of Florida, 1345 Center Drive, Gainesville, Florida, 32610, USA.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Shao', 'Affiliation': 'Department of Pharmaceutics, College of Pharmacy, University of Florida, 1345 Center Drive, Gainesville, Florida, 32610, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Seay', 'Affiliation': 'Division of Pediatric Pulmonary and Sleep Medicine, Department of Pediatrics, College of Medicine, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Mutasim N', 'Initials': 'MN', 'LastName': 'Abu-Hasan', 'Affiliation': 'Division of Pediatric Pulmonary and Sleep Medicine, Department of Pediatrics, College of Medicine, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Sandra M', 'Initials': 'SM', 'LastName': 'Baumstein', 'Affiliation': 'Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, 6550 Sanger Road, Gainesville, Florida, 32827-7445, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Winner', 'Affiliation': 'Department of Statistics, College of Liberal Arts & Sciences, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Jagdeep', 'Initials': 'J', 'LastName': 'Shur', 'Affiliation': 'Department of Pharmacy & Pharmacology, Centre for Therapeutic Innovation, University of Bath, Bath, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Price', 'Affiliation': 'Department of Pharmacy & Pharmacology, Centre for Therapeutic Innovation, University of Bath, Bath, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hindle', 'Affiliation': 'Department of Pharmaceutics, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Xiangyin', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'Department of Pharmaceutics, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Carrasco', 'Affiliation': 'Worldwide Clinical Trials, Austin, Texas, USA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Sandell', 'Affiliation': 'S5 Consulting, Blentarp, Sweden.'}, {'ForeName': 'Oluwamurewa', 'Initials': 'O', 'LastName': 'Oguntimein', 'Affiliation': 'Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Minori', 'Initials': 'M', 'LastName': 'Kinjo', 'Affiliation': 'Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Renishkumar', 'Initials': 'R', 'LastName': 'Delvadia', 'Affiliation': 'Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Bhawana', 'Initials': 'B', 'LastName': 'Saluja', 'Affiliation': 'Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Sau L', 'Initials': 'SL', 'LastName': 'Lee', 'Affiliation': 'Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Denise S', 'Initials': 'DS', 'LastName': 'Conti', 'Affiliation': 'Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Jürgen B', 'Initials': 'JB', 'LastName': 'Bulitta', 'Affiliation': 'Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, 6550 Sanger Road, Gainesville, Florida, 32827-7445, USA. jbulitta@cop.ufl.edu.'}]",The AAPS journal,['10.1208/s12248-021-00569-x'] 2695,33536271,Low-Dose vs Standard-Dose Alteplase in Acute Lacunar Ischemic Stroke: The ENCHANTED Trial.,"OBJECTIVE To determine any differential efficacy and safety of low- vs standard-dose IV alteplase for lacunar vs nonlacunar acute ischemic stroke (AIS), we performed post hoc analyzes from the Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED) alteplase dose arm. METHODS In a cohort of 3,297 ENCHANTED participants, we identified those with lacunar or nonlacunar AIS with different levels of confidence (definite/according to prespecified definitions based on clinical and adjudicated imaging findings. Logistic regression models were used to determine associations of lacunar AIS with 90-day outcomes (primary, modified Rankin Scale [mRS] scores 2-6; secondary, other mRS scores, intracerebral hemorrhage [ICH], and early neurologic deterioration or death) and treatment effects of low- vs standard-dose alteplase across lacunar and nonlacunar AIS with adjustment for baseline covariables. RESULTS Of 2,588 participants with available imaging and clinical data, we classified cases as definite/probable lacunar (n = 490) or nonlacunar AIS (n = 2,098) for primary analyses. Regardless of alteplase dose received, lacunar AIS participants had favorable functional (mRS 2-6, adjusted odds ratio [95% confidence interval] 0.60 [0.47-0.77]) and other clinical or safety outcomes compared to participants with nonlacunar AIS. Low-dose alteplase (versus standard) had no differential effect on functional outcomes (mRS 2-6, 1.04 [0.87-1.24]) but reduced the risk of symptomatic ICH in all included participants. There were no differential treatment effects of low- vs standard-dose alteplase on all outcomes across lacunar and nonlacunar AIS (all p interaction ≥0.07). CONCLUSIONS We found no evidence from the ENCHANTED trial that low-dose alteplase had any advantages over standard dose for definite/probable lacunar AIS. CLASSIFICATION OF EVIDENCE This study provides Class II evidence that for patients with lacunar AIS, low-dose alteplase had no additional benefit or safety over standard-dose alteplase. CLINICAL TRIAL REGISTRATION Clinicaltrials.gov identifier NCT01422616.",2021,"There were no differential treatment effects of low- vs standard-dose alteplase on all outcomes across lacunar and nonlacunar AIS (all p interaction ≥0.07). ","['lacunar vs nonlacunar acute ischemic stroke (AIS', '3,297 ENCHANTED participants, we identified those with lacunar or nonlacunar AIS with different levels of confidence (definite/according to prespecified definitions based on clinical and adjudicated imaging findings', '2,588 participants with available imaging and clinical data, we classified cases as definite/probable lacunar (n = 490) or nonlacunar AIS (n = 2,098) for primary analyses', 'Acute Lacunar Ischemic Stroke']","['lacunar AIS', 'Low-Dose vs Standard-Dose Alteplase', 'low- vs standard-dose IV alteplase']","['risk of symptomatic ICH', 'lacunar AIS with 90-day outcomes (primary, modified Rankin Scale [mRS] scores 2-6; secondary, other mRS scores, intracerebral hemorrhage [ICH], and early neurologic deterioration or death', 'functional outcomes']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0039585', 'cui_str': 'Androgen resistance syndrome'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0039585', 'cui_str': 'Androgen resistance syndrome'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0019191', 'cui_str': 'Infectious Canine Hepatitis'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",3297.0,0.177545,"There were no differential treatment effects of low- vs standard-dose alteplase on all outcomes across lacunar and nonlacunar AIS (all p interaction ≥0.07). ","[{'ForeName': 'Zien', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'From The George Institute for Global Health, Faculty of Medicine (Z.Z., C.D., C.X., S. Yoshimura, C.C., T.T.-Y., A.M., X.C., M.L.H., M.W., J.C., C.S.A.), and South Western Clinical School (M.W.P.), University of New South Wales Sydney, Australia; Department of Radiology (Z.Z., J.X.), Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, China; Department of Neurology (C.D., C.C., C.S.A.), Royal Prince Alfred Hospital, Sydney Health Partners; Sydney Medical School (C.D., C.C.), University of Sydney, Australia; Department of Neurosurgery (C.X.), West China Hospital, Sichuan University, Chengdu, China; Department of Cerebrovascular Medicine (S. Yoshimura, T.T.-Y.), National Cerebral and Cardiovascular Center, Osaka; Department of Neurology and Neuroscience (T.T.-Y.), Nagoya City University Graduate School of Medical Science, Japan; Department of Neurology (S. You), the Second Affiliated Hospital of Soochow University, Suzhou, China; The George Institute for Global Health, School of Public Health (M.W.), Imperial College, London; Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Center (T.G.R.), University of Leicester, UK; Melbourne Brain Centre, Royal Melbourne Hospital University Department of Medicine (M.W.P.), University of Melbourne, Australia; Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine (A.M.D.), University of Calgary, Canada; Westmead Applied Research Centre (R.I.L.), University of Sydney, Australia; Division of Neuroimaging Sciences, Edinburgh Imaging and Centre for Clinical Brain Sciences (G.M., J.M.W.), and UK Dementia Research Institute (J.M.W.), University of Edinburgh; and The George Institute China at Peking University Health Science Center (C.S.A.), Beijing, China.'}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Delcourt', 'Affiliation': 'From The George Institute for Global Health, Faculty of Medicine (Z.Z., C.D., C.X., S. Yoshimura, C.C., T.T.-Y., A.M., X.C., M.L.H., M.W., J.C., C.S.A.), and South Western Clinical School (M.W.P.), University of New South Wales Sydney, Australia; Department of Radiology (Z.Z., J.X.), Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, China; Department of Neurology (C.D., C.C., C.S.A.), Royal Prince Alfred Hospital, Sydney Health Partners; Sydney Medical School (C.D., C.C.), University of Sydney, Australia; Department of Neurosurgery (C.X.), West China Hospital, Sichuan University, Chengdu, China; Department of Cerebrovascular Medicine (S. Yoshimura, T.T.-Y.), National Cerebral and Cardiovascular Center, Osaka; Department of Neurology and Neuroscience (T.T.-Y.), Nagoya City University Graduate School of Medical Science, Japan; Department of Neurology (S. You), the Second Affiliated Hospital of Soochow University, Suzhou, China; The George Institute for Global Health, School of Public Health (M.W.), Imperial College, London; Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Center (T.G.R.), University of Leicester, UK; Melbourne Brain Centre, Royal Melbourne Hospital University Department of Medicine (M.W.P.), University of Melbourne, Australia; Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine (A.M.D.), University of Calgary, Canada; Westmead Applied Research Centre (R.I.L.), University of Sydney, Australia; Division of Neuroimaging Sciences, Edinburgh Imaging and Centre for Clinical Brain Sciences (G.M., J.M.W.), and UK Dementia Research Institute (J.M.W.), University of Edinburgh; and The George Institute China at Peking University Health Science Center (C.S.A.), Beijing, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Xia', 'Affiliation': 'From The George Institute for Global Health, Faculty of Medicine (Z.Z., C.D., C.X., S. Yoshimura, C.C., T.T.-Y., A.M., X.C., M.L.H., M.W., J.C., C.S.A.), and South Western Clinical School (M.W.P.), University of New South Wales Sydney, Australia; Department of Radiology (Z.Z., J.X.), Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, China; Department of Neurology (C.D., C.C., C.S.A.), Royal Prince Alfred Hospital, Sydney Health Partners; Sydney Medical School (C.D., C.C.), University of Sydney, Australia; Department of Neurosurgery (C.X.), West China Hospital, Sichuan University, Chengdu, China; Department of Cerebrovascular Medicine (S. Yoshimura, T.T.-Y.), National Cerebral and Cardiovascular Center, Osaka; Department of Neurology and Neuroscience (T.T.-Y.), Nagoya City University Graduate School of Medical Science, Japan; Department of Neurology (S. You), the Second Affiliated Hospital of Soochow University, Suzhou, China; The George Institute for Global Health, School of Public Health (M.W.), Imperial College, London; Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Center (T.G.R.), University of Leicester, UK; Melbourne Brain Centre, Royal Melbourne Hospital University Department of Medicine (M.W.P.), University of Melbourne, Australia; Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine (A.M.D.), University of Calgary, Canada; Westmead Applied Research Centre (R.I.L.), University of Sydney, Australia; Division of Neuroimaging Sciences, Edinburgh Imaging and Centre for Clinical Brain Sciences (G.M., J.M.W.), and UK Dementia Research Institute (J.M.W.), University of Edinburgh; and The George Institute China at Peking University Health Science Center (C.S.A.), Beijing, China.'}, {'ForeName': 'Sohei', 'Initials': 'S', 'LastName': 'Yoshimura', 'Affiliation': 'From The George Institute for Global Health, Faculty of Medicine (Z.Z., C.D., C.X., S. Yoshimura, C.C., T.T.-Y., A.M., X.C., M.L.H., M.W., J.C., C.S.A.), and South Western Clinical School (M.W.P.), University of New South Wales Sydney, Australia; Department of Radiology (Z.Z., J.X.), Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, China; Department of Neurology (C.D., C.C., C.S.A.), Royal Prince Alfred Hospital, Sydney Health Partners; Sydney Medical School (C.D., C.C.), University of Sydney, Australia; Department of Neurosurgery (C.X.), West China Hospital, Sichuan University, Chengdu, China; Department of Cerebrovascular Medicine (S. Yoshimura, T.T.-Y.), National Cerebral and Cardiovascular Center, Osaka; Department of Neurology and Neuroscience (T.T.-Y.), Nagoya City University Graduate School of Medical Science, Japan; Department of Neurology (S. You), the Second Affiliated Hospital of Soochow University, Suzhou, China; The George Institute for Global Health, School of Public Health (M.W.), Imperial College, London; Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Center (T.G.R.), University of Leicester, UK; Melbourne Brain Centre, Royal Melbourne Hospital University Department of Medicine (M.W.P.), University of Melbourne, Australia; Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine (A.M.D.), University of Calgary, Canada; Westmead Applied Research Centre (R.I.L.), University of Sydney, Australia; Division of Neuroimaging Sciences, Edinburgh Imaging and Centre for Clinical Brain Sciences (G.M., J.M.W.), and UK Dementia Research Institute (J.M.W.), University of Edinburgh; and The George Institute China at Peking University Health Science Center (C.S.A.), Beijing, China.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Carcel', 'Affiliation': 'From The George Institute for Global Health, Faculty of Medicine (Z.Z., C.D., C.X., S. Yoshimura, C.C., T.T.-Y., A.M., X.C., M.L.H., M.W., J.C., C.S.A.), and South Western Clinical School (M.W.P.), University of New South Wales Sydney, Australia; Department of Radiology (Z.Z., J.X.), Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, China; Department of Neurology (C.D., C.C., C.S.A.), Royal Prince Alfred Hospital, Sydney Health Partners; Sydney Medical School (C.D., C.C.), University of Sydney, Australia; Department of Neurosurgery (C.X.), West China Hospital, Sichuan University, Chengdu, China; Department of Cerebrovascular Medicine (S. Yoshimura, T.T.-Y.), National Cerebral and Cardiovascular Center, Osaka; Department of Neurology and Neuroscience (T.T.-Y.), Nagoya City University Graduate School of Medical Science, Japan; Department of Neurology (S. You), the Second Affiliated Hospital of Soochow University, Suzhou, China; The George Institute for Global Health, School of Public Health (M.W.), Imperial College, London; Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Center (T.G.R.), University of Leicester, UK; Melbourne Brain Centre, Royal Melbourne Hospital University Department of Medicine (M.W.P.), University of Melbourne, Australia; Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine (A.M.D.), University of Calgary, Canada; Westmead Applied Research Centre (R.I.L.), University of Sydney, Australia; Division of Neuroimaging Sciences, Edinburgh Imaging and Centre for Clinical Brain Sciences (G.M., J.M.W.), and UK Dementia Research Institute (J.M.W.), University of Edinburgh; and The George Institute China at Peking University Health Science Center (C.S.A.), Beijing, China.'}, {'ForeName': 'Takako', 'Initials': 'T', 'LastName': 'Torii-Yoshimura', 'Affiliation': 'From The George Institute for Global Health, Faculty of Medicine (Z.Z., C.D., C.X., S. Yoshimura, C.C., T.T.-Y., A.M., X.C., M.L.H., M.W., J.C., C.S.A.), and South Western Clinical School (M.W.P.), University of New South Wales Sydney, Australia; Department of Radiology (Z.Z., J.X.), Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, China; Department of Neurology (C.D., C.C., C.S.A.), Royal Prince Alfred Hospital, Sydney Health Partners; Sydney Medical School (C.D., C.C.), University of Sydney, Australia; Department of Neurosurgery (C.X.), West China Hospital, Sichuan University, Chengdu, China; Department of Cerebrovascular Medicine (S. Yoshimura, T.T.-Y.), National Cerebral and Cardiovascular Center, Osaka; Department of Neurology and Neuroscience (T.T.-Y.), Nagoya City University Graduate School of Medical Science, Japan; Department of Neurology (S. You), the Second Affiliated Hospital of Soochow University, Suzhou, China; The George Institute for Global Health, School of Public Health (M.W.), Imperial College, London; Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Center (T.G.R.), University of Leicester, UK; Melbourne Brain Centre, Royal Melbourne Hospital University Department of Medicine (M.W.P.), University of Melbourne, Australia; Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine (A.M.D.), University of Calgary, Canada; Westmead Applied Research Centre (R.I.L.), University of Sydney, Australia; Division of Neuroimaging Sciences, Edinburgh Imaging and Centre for Clinical Brain Sciences (G.M., J.M.W.), and UK Dementia Research Institute (J.M.W.), University of Edinburgh; and The George Institute China at Peking University Health Science Center (C.S.A.), Beijing, China.'}, {'ForeName': 'Shoujiang', 'Initials': 'S', 'LastName': 'You', 'Affiliation': 'From The George Institute for Global Health, Faculty of Medicine (Z.Z., C.D., C.X., S. Yoshimura, C.C., T.T.-Y., A.M., X.C., M.L.H., M.W., J.C., C.S.A.), and South Western Clinical School (M.W.P.), University of New South Wales Sydney, Australia; Department of Radiology (Z.Z., J.X.), Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, China; Department of Neurology (C.D., C.C., C.S.A.), Royal Prince Alfred Hospital, Sydney Health Partners; Sydney Medical School (C.D., C.C.), University of Sydney, Australia; Department of Neurosurgery (C.X.), West China Hospital, Sichuan University, Chengdu, China; Department of Cerebrovascular Medicine (S. Yoshimura, T.T.-Y.), National Cerebral and Cardiovascular Center, Osaka; Department of Neurology and Neuroscience (T.T.-Y.), Nagoya City University Graduate School of Medical Science, Japan; Department of Neurology (S. You), the Second Affiliated Hospital of Soochow University, Suzhou, China; The George Institute for Global Health, School of Public Health (M.W.), Imperial College, London; Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Center (T.G.R.), University of Leicester, UK; Melbourne Brain Centre, Royal Melbourne Hospital University Department of Medicine (M.W.P.), University of Melbourne, Australia; Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine (A.M.D.), University of Calgary, Canada; Westmead Applied Research Centre (R.I.L.), University of Sydney, Australia; Division of Neuroimaging Sciences, Edinburgh Imaging and Centre for Clinical Brain Sciences (G.M., J.M.W.), and UK Dementia Research Institute (J.M.W.), University of Edinburgh; and The George Institute China at Peking University Health Science Center (C.S.A.), Beijing, China.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Malavera', 'Affiliation': 'From The George Institute for Global Health, Faculty of Medicine (Z.Z., C.D., C.X., S. Yoshimura, C.C., T.T.-Y., A.M., X.C., M.L.H., M.W., J.C., C.S.A.), and South Western Clinical School (M.W.P.), University of New South Wales Sydney, Australia; Department of Radiology (Z.Z., J.X.), Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, China; Department of Neurology (C.D., C.C., C.S.A.), Royal Prince Alfred Hospital, Sydney Health Partners; Sydney Medical School (C.D., C.C.), University of Sydney, Australia; Department of Neurosurgery (C.X.), West China Hospital, Sichuan University, Chengdu, China; Department of Cerebrovascular Medicine (S. Yoshimura, T.T.-Y.), National Cerebral and Cardiovascular Center, Osaka; Department of Neurology and Neuroscience (T.T.-Y.), Nagoya City University Graduate School of Medical Science, Japan; Department of Neurology (S. You), the Second Affiliated Hospital of Soochow University, Suzhou, China; The George Institute for Global Health, School of Public Health (M.W.), Imperial College, London; Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Center (T.G.R.), University of Leicester, UK; Melbourne Brain Centre, Royal Melbourne Hospital University Department of Medicine (M.W.P.), University of Melbourne, Australia; Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine (A.M.D.), University of Calgary, Canada; Westmead Applied Research Centre (R.I.L.), University of Sydney, Australia; Division of Neuroimaging Sciences, Edinburgh Imaging and Centre for Clinical Brain Sciences (G.M., J.M.W.), and UK Dementia Research Institute (J.M.W.), University of Edinburgh; and The George Institute China at Peking University Health Science Center (C.S.A.), Beijing, China.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'From The George Institute for Global Health, Faculty of Medicine (Z.Z., C.D., C.X., S. Yoshimura, C.C., T.T.-Y., A.M., X.C., M.L.H., M.W., J.C., C.S.A.), and South Western Clinical School (M.W.P.), University of New South Wales Sydney, Australia; Department of Radiology (Z.Z., J.X.), Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, China; Department of Neurology (C.D., C.C., C.S.A.), Royal Prince Alfred Hospital, Sydney Health Partners; Sydney Medical School (C.D., C.C.), University of Sydney, Australia; Department of Neurosurgery (C.X.), West China Hospital, Sichuan University, Chengdu, China; Department of Cerebrovascular Medicine (S. Yoshimura, T.T.-Y.), National Cerebral and Cardiovascular Center, Osaka; Department of Neurology and Neuroscience (T.T.-Y.), Nagoya City University Graduate School of Medical Science, Japan; Department of Neurology (S. You), the Second Affiliated Hospital of Soochow University, Suzhou, China; The George Institute for Global Health, School of Public Health (M.W.), Imperial College, London; Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Center (T.G.R.), University of Leicester, UK; Melbourne Brain Centre, Royal Melbourne Hospital University Department of Medicine (M.W.P.), University of Melbourne, Australia; Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine (A.M.D.), University of Calgary, Canada; Westmead Applied Research Centre (R.I.L.), University of Sydney, Australia; Division of Neuroimaging Sciences, Edinburgh Imaging and Centre for Clinical Brain Sciences (G.M., J.M.W.), and UK Dementia Research Institute (J.M.W.), University of Edinburgh; and The George Institute China at Peking University Health Science Center (C.S.A.), Beijing, China.'}, {'ForeName': 'Maree L', 'Initials': 'ML', 'LastName': 'Hackett', 'Affiliation': 'From The George Institute for Global Health, Faculty of Medicine (Z.Z., C.D., C.X., S. Yoshimura, C.C., T.T.-Y., A.M., X.C., M.L.H., M.W., J.C., C.S.A.), and South Western Clinical School (M.W.P.), University of New South Wales Sydney, Australia; Department of Radiology (Z.Z., J.X.), Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, China; Department of Neurology (C.D., C.C., C.S.A.), Royal Prince Alfred Hospital, Sydney Health Partners; Sydney Medical School (C.D., C.C.), University of Sydney, Australia; Department of Neurosurgery (C.X.), West China Hospital, Sichuan University, Chengdu, China; Department of Cerebrovascular Medicine (S. Yoshimura, T.T.-Y.), National Cerebral and Cardiovascular Center, Osaka; Department of Neurology and Neuroscience (T.T.-Y.), Nagoya City University Graduate School of Medical Science, Japan; Department of Neurology (S. You), the Second Affiliated Hospital of Soochow University, Suzhou, China; The George Institute for Global Health, School of Public Health (M.W.), Imperial College, London; Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Center (T.G.R.), University of Leicester, UK; Melbourne Brain Centre, Royal Melbourne Hospital University Department of Medicine (M.W.P.), University of Melbourne, Australia; Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine (A.M.D.), University of Calgary, Canada; Westmead Applied Research Centre (R.I.L.), University of Sydney, Australia; Division of Neuroimaging Sciences, Edinburgh Imaging and Centre for Clinical Brain Sciences (G.M., J.M.W.), and UK Dementia Research Institute (J.M.W.), University of Edinburgh; and The George Institute China at Peking University Health Science Center (C.S.A.), Beijing, China.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Woodward', 'Affiliation': 'From The George Institute for Global Health, Faculty of Medicine (Z.Z., C.D., C.X., S. Yoshimura, C.C., T.T.-Y., A.M., X.C., M.L.H., M.W., J.C., C.S.A.), and South Western Clinical School (M.W.P.), University of New South Wales Sydney, Australia; Department of Radiology (Z.Z., J.X.), Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, China; Department of Neurology (C.D., C.C., C.S.A.), Royal Prince Alfred Hospital, Sydney Health Partners; Sydney Medical School (C.D., C.C.), University of Sydney, Australia; Department of Neurosurgery (C.X.), West China Hospital, Sichuan University, Chengdu, China; Department of Cerebrovascular Medicine (S. Yoshimura, T.T.-Y.), National Cerebral and Cardiovascular Center, Osaka; Department of Neurology and Neuroscience (T.T.-Y.), Nagoya City University Graduate School of Medical Science, Japan; Department of Neurology (S. You), the Second Affiliated Hospital of Soochow University, Suzhou, China; The George Institute for Global Health, School of Public Health (M.W.), Imperial College, London; Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Center (T.G.R.), University of Leicester, UK; Melbourne Brain Centre, Royal Melbourne Hospital University Department of Medicine (M.W.P.), University of Melbourne, Australia; Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine (A.M.D.), University of Calgary, Canada; Westmead Applied Research Centre (R.I.L.), University of Sydney, Australia; Division of Neuroimaging Sciences, Edinburgh Imaging and Centre for Clinical Brain Sciences (G.M., J.M.W.), and UK Dementia Research Institute (J.M.W.), University of Edinburgh; and The George Institute China at Peking University Health Science Center (C.S.A.), Beijing, China.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chalmers', 'Affiliation': 'From The George Institute for Global Health, Faculty of Medicine (Z.Z., C.D., C.X., S. Yoshimura, C.C., T.T.-Y., A.M., X.C., M.L.H., M.W., J.C., C.S.A.), and South Western Clinical School (M.W.P.), University of New South Wales Sydney, Australia; Department of Radiology (Z.Z., J.X.), Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, China; Department of Neurology (C.D., C.C., C.S.A.), Royal Prince Alfred Hospital, Sydney Health Partners; Sydney Medical School (C.D., C.C.), University of Sydney, Australia; Department of Neurosurgery (C.X.), West China Hospital, Sichuan University, Chengdu, China; Department of Cerebrovascular Medicine (S. Yoshimura, T.T.-Y.), National Cerebral and Cardiovascular Center, Osaka; Department of Neurology and Neuroscience (T.T.-Y.), Nagoya City University Graduate School of Medical Science, Japan; Department of Neurology (S. You), the Second Affiliated Hospital of Soochow University, Suzhou, China; The George Institute for Global Health, School of Public Health (M.W.), Imperial College, London; Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Center (T.G.R.), University of Leicester, UK; Melbourne Brain Centre, Royal Melbourne Hospital University Department of Medicine (M.W.P.), University of Melbourne, Australia; Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine (A.M.D.), University of Calgary, Canada; Westmead Applied Research Centre (R.I.L.), University of Sydney, Australia; Division of Neuroimaging Sciences, Edinburgh Imaging and Centre for Clinical Brain Sciences (G.M., J.M.W.), and UK Dementia Research Institute (J.M.W.), University of Edinburgh; and The George Institute China at Peking University Health Science Center (C.S.A.), Beijing, China.'}, {'ForeName': 'Jianrong', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'From The George Institute for Global Health, Faculty of Medicine (Z.Z., C.D., C.X., S. Yoshimura, C.C., T.T.-Y., A.M., X.C., M.L.H., M.W., J.C., C.S.A.), and South Western Clinical School (M.W.P.), University of New South Wales Sydney, Australia; Department of Radiology (Z.Z., J.X.), Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, China; Department of Neurology (C.D., C.C., C.S.A.), Royal Prince Alfred Hospital, Sydney Health Partners; Sydney Medical School (C.D., C.C.), University of Sydney, Australia; Department of Neurosurgery (C.X.), West China Hospital, Sichuan University, Chengdu, China; Department of Cerebrovascular Medicine (S. Yoshimura, T.T.-Y.), National Cerebral and Cardiovascular Center, Osaka; Department of Neurology and Neuroscience (T.T.-Y.), Nagoya City University Graduate School of Medical Science, Japan; Department of Neurology (S. You), the Second Affiliated Hospital of Soochow University, Suzhou, China; The George Institute for Global Health, School of Public Health (M.W.), Imperial College, London; Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Center (T.G.R.), University of Leicester, UK; Melbourne Brain Centre, Royal Melbourne Hospital University Department of Medicine (M.W.P.), University of Melbourne, Australia; Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine (A.M.D.), University of Calgary, Canada; Westmead Applied Research Centre (R.I.L.), University of Sydney, Australia; Division of Neuroimaging Sciences, Edinburgh Imaging and Centre for Clinical Brain Sciences (G.M., J.M.W.), and UK Dementia Research Institute (J.M.W.), University of Edinburgh; and The George Institute China at Peking University Health Science Center (C.S.A.), Beijing, China.'}, {'ForeName': 'Thompson G', 'Initials': 'TG', 'LastName': 'Robinson', 'Affiliation': 'From The George Institute for Global Health, Faculty of Medicine (Z.Z., C.D., C.X., S. Yoshimura, C.C., T.T.-Y., A.M., X.C., M.L.H., M.W., J.C., C.S.A.), and South Western Clinical School (M.W.P.), University of New South Wales Sydney, Australia; Department of Radiology (Z.Z., J.X.), Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, China; Department of Neurology (C.D., C.C., C.S.A.), Royal Prince Alfred Hospital, Sydney Health Partners; Sydney Medical School (C.D., C.C.), University of Sydney, Australia; Department of Neurosurgery (C.X.), West China Hospital, Sichuan University, Chengdu, China; Department of Cerebrovascular Medicine (S. Yoshimura, T.T.-Y.), National Cerebral and Cardiovascular Center, Osaka; Department of Neurology and Neuroscience (T.T.-Y.), Nagoya City University Graduate School of Medical Science, Japan; Department of Neurology (S. You), the Second Affiliated Hospital of Soochow University, Suzhou, China; The George Institute for Global Health, School of Public Health (M.W.), Imperial College, London; Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Center (T.G.R.), University of Leicester, UK; Melbourne Brain Centre, Royal Melbourne Hospital University Department of Medicine (M.W.P.), University of Melbourne, Australia; Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine (A.M.D.), University of Calgary, Canada; Westmead Applied Research Centre (R.I.L.), University of Sydney, Australia; Division of Neuroimaging Sciences, Edinburgh Imaging and Centre for Clinical Brain Sciences (G.M., J.M.W.), and UK Dementia Research Institute (J.M.W.), University of Edinburgh; and The George Institute China at Peking University Health Science Center (C.S.A.), Beijing, China.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Parsons', 'Affiliation': 'From The George Institute for Global Health, Faculty of Medicine (Z.Z., C.D., C.X., S. Yoshimura, C.C., T.T.-Y., A.M., X.C., M.L.H., M.W., J.C., C.S.A.), and South Western Clinical School (M.W.P.), University of New South Wales Sydney, Australia; Department of Radiology (Z.Z., J.X.), Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, China; Department of Neurology (C.D., C.C., C.S.A.), Royal Prince Alfred Hospital, Sydney Health Partners; Sydney Medical School (C.D., C.C.), University of Sydney, Australia; Department of Neurosurgery (C.X.), West China Hospital, Sichuan University, Chengdu, China; Department of Cerebrovascular Medicine (S. Yoshimura, T.T.-Y.), National Cerebral and Cardiovascular Center, Osaka; Department of Neurology and Neuroscience (T.T.-Y.), Nagoya City University Graduate School of Medical Science, Japan; Department of Neurology (S. You), the Second Affiliated Hospital of Soochow University, Suzhou, China; The George Institute for Global Health, School of Public Health (M.W.), Imperial College, London; Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Center (T.G.R.), University of Leicester, UK; Melbourne Brain Centre, Royal Melbourne Hospital University Department of Medicine (M.W.P.), University of Melbourne, Australia; Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine (A.M.D.), University of Calgary, Canada; Westmead Applied Research Centre (R.I.L.), University of Sydney, Australia; Division of Neuroimaging Sciences, Edinburgh Imaging and Centre for Clinical Brain Sciences (G.M., J.M.W.), and UK Dementia Research Institute (J.M.W.), University of Edinburgh; and The George Institute China at Peking University Health Science Center (C.S.A.), Beijing, China.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Demchuk', 'Affiliation': 'From The George Institute for Global Health, Faculty of Medicine (Z.Z., C.D., C.X., S. Yoshimura, C.C., T.T.-Y., A.M., X.C., M.L.H., M.W., J.C., C.S.A.), and South Western Clinical School (M.W.P.), University of New South Wales Sydney, Australia; Department of Radiology (Z.Z., J.X.), Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, China; Department of Neurology (C.D., C.C., C.S.A.), Royal Prince Alfred Hospital, Sydney Health Partners; Sydney Medical School (C.D., C.C.), University of Sydney, Australia; Department of Neurosurgery (C.X.), West China Hospital, Sichuan University, Chengdu, China; Department of Cerebrovascular Medicine (S. Yoshimura, T.T.-Y.), National Cerebral and Cardiovascular Center, Osaka; Department of Neurology and Neuroscience (T.T.-Y.), Nagoya City University Graduate School of Medical Science, Japan; Department of Neurology (S. You), the Second Affiliated Hospital of Soochow University, Suzhou, China; The George Institute for Global Health, School of Public Health (M.W.), Imperial College, London; Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Center (T.G.R.), University of Leicester, UK; Melbourne Brain Centre, Royal Melbourne Hospital University Department of Medicine (M.W.P.), University of Melbourne, Australia; Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine (A.M.D.), University of Calgary, Canada; Westmead Applied Research Centre (R.I.L.), University of Sydney, Australia; Division of Neuroimaging Sciences, Edinburgh Imaging and Centre for Clinical Brain Sciences (G.M., J.M.W.), and UK Dementia Research Institute (J.M.W.), University of Edinburgh; and The George Institute China at Peking University Health Science Center (C.S.A.), Beijing, China.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Lindley', 'Affiliation': 'From The George Institute for Global Health, Faculty of Medicine (Z.Z., C.D., C.X., S. Yoshimura, C.C., T.T.-Y., A.M., X.C., M.L.H., M.W., J.C., C.S.A.), and South Western Clinical School (M.W.P.), University of New South Wales Sydney, Australia; Department of Radiology (Z.Z., J.X.), Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, China; Department of Neurology (C.D., C.C., C.S.A.), Royal Prince Alfred Hospital, Sydney Health Partners; Sydney Medical School (C.D., C.C.), University of Sydney, Australia; Department of Neurosurgery (C.X.), West China Hospital, Sichuan University, Chengdu, China; Department of Cerebrovascular Medicine (S. Yoshimura, T.T.-Y.), National Cerebral and Cardiovascular Center, Osaka; Department of Neurology and Neuroscience (T.T.-Y.), Nagoya City University Graduate School of Medical Science, Japan; Department of Neurology (S. You), the Second Affiliated Hospital of Soochow University, Suzhou, China; The George Institute for Global Health, School of Public Health (M.W.), Imperial College, London; Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Center (T.G.R.), University of Leicester, UK; Melbourne Brain Centre, Royal Melbourne Hospital University Department of Medicine (M.W.P.), University of Melbourne, Australia; Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine (A.M.D.), University of Calgary, Canada; Westmead Applied Research Centre (R.I.L.), University of Sydney, Australia; Division of Neuroimaging Sciences, Edinburgh Imaging and Centre for Clinical Brain Sciences (G.M., J.M.W.), and UK Dementia Research Institute (J.M.W.), University of Edinburgh; and The George Institute China at Peking University Health Science Center (C.S.A.), Beijing, China.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Mair', 'Affiliation': 'From The George Institute for Global Health, Faculty of Medicine (Z.Z., C.D., C.X., S. Yoshimura, C.C., T.T.-Y., A.M., X.C., M.L.H., M.W., J.C., C.S.A.), and South Western Clinical School (M.W.P.), University of New South Wales Sydney, Australia; Department of Radiology (Z.Z., J.X.), Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, China; Department of Neurology (C.D., C.C., C.S.A.), Royal Prince Alfred Hospital, Sydney Health Partners; Sydney Medical School (C.D., C.C.), University of Sydney, Australia; Department of Neurosurgery (C.X.), West China Hospital, Sichuan University, Chengdu, China; Department of Cerebrovascular Medicine (S. Yoshimura, T.T.-Y.), National Cerebral and Cardiovascular Center, Osaka; Department of Neurology and Neuroscience (T.T.-Y.), Nagoya City University Graduate School of Medical Science, Japan; Department of Neurology (S. You), the Second Affiliated Hospital of Soochow University, Suzhou, China; The George Institute for Global Health, School of Public Health (M.W.), Imperial College, London; Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Center (T.G.R.), University of Leicester, UK; Melbourne Brain Centre, Royal Melbourne Hospital University Department of Medicine (M.W.P.), University of Melbourne, Australia; Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine (A.M.D.), University of Calgary, Canada; Westmead Applied Research Centre (R.I.L.), University of Sydney, Australia; Division of Neuroimaging Sciences, Edinburgh Imaging and Centre for Clinical Brain Sciences (G.M., J.M.W.), and UK Dementia Research Institute (J.M.W.), University of Edinburgh; and The George Institute China at Peking University Health Science Center (C.S.A.), Beijing, China.'}, {'ForeName': 'Joanna M', 'Initials': 'JM', 'LastName': 'Wardlaw', 'Affiliation': 'From The George Institute for Global Health, Faculty of Medicine (Z.Z., C.D., C.X., S. Yoshimura, C.C., T.T.-Y., A.M., X.C., M.L.H., M.W., J.C., C.S.A.), and South Western Clinical School (M.W.P.), University of New South Wales Sydney, Australia; Department of Radiology (Z.Z., J.X.), Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, China; Department of Neurology (C.D., C.C., C.S.A.), Royal Prince Alfred Hospital, Sydney Health Partners; Sydney Medical School (C.D., C.C.), University of Sydney, Australia; Department of Neurosurgery (C.X.), West China Hospital, Sichuan University, Chengdu, China; Department of Cerebrovascular Medicine (S. Yoshimura, T.T.-Y.), National Cerebral and Cardiovascular Center, Osaka; Department of Neurology and Neuroscience (T.T.-Y.), Nagoya City University Graduate School of Medical Science, Japan; Department of Neurology (S. You), the Second Affiliated Hospital of Soochow University, Suzhou, China; The George Institute for Global Health, School of Public Health (M.W.), Imperial College, London; Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Center (T.G.R.), University of Leicester, UK; Melbourne Brain Centre, Royal Melbourne Hospital University Department of Medicine (M.W.P.), University of Melbourne, Australia; Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine (A.M.D.), University of Calgary, Canada; Westmead Applied Research Centre (R.I.L.), University of Sydney, Australia; Division of Neuroimaging Sciences, Edinburgh Imaging and Centre for Clinical Brain Sciences (G.M., J.M.W.), and UK Dementia Research Institute (J.M.W.), University of Edinburgh; and The George Institute China at Peking University Health Science Center (C.S.A.), Beijing, China.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'From The George Institute for Global Health, Faculty of Medicine (Z.Z., C.D., C.X., S. Yoshimura, C.C., T.T.-Y., A.M., X.C., M.L.H., M.W., J.C., C.S.A.), and South Western Clinical School (M.W.P.), University of New South Wales Sydney, Australia; Department of Radiology (Z.Z., J.X.), Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, China; Department of Neurology (C.D., C.C., C.S.A.), Royal Prince Alfred Hospital, Sydney Health Partners; Sydney Medical School (C.D., C.C.), University of Sydney, Australia; Department of Neurosurgery (C.X.), West China Hospital, Sichuan University, Chengdu, China; Department of Cerebrovascular Medicine (S. Yoshimura, T.T.-Y.), National Cerebral and Cardiovascular Center, Osaka; Department of Neurology and Neuroscience (T.T.-Y.), Nagoya City University Graduate School of Medical Science, Japan; Department of Neurology (S. You), the Second Affiliated Hospital of Soochow University, Suzhou, China; The George Institute for Global Health, School of Public Health (M.W.), Imperial College, London; Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Center (T.G.R.), University of Leicester, UK; Melbourne Brain Centre, Royal Melbourne Hospital University Department of Medicine (M.W.P.), University of Melbourne, Australia; Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine (A.M.D.), University of Calgary, Canada; Westmead Applied Research Centre (R.I.L.), University of Sydney, Australia; Division of Neuroimaging Sciences, Edinburgh Imaging and Centre for Clinical Brain Sciences (G.M., J.M.W.), and UK Dementia Research Institute (J.M.W.), University of Edinburgh; and The George Institute China at Peking University Health Science Center (C.S.A.), Beijing, China. canderson@georgeinstitute.org.au.'}]",Neurology,['10.1212/WNL.0000000000011598'] 2696,33795561,Patient-Reported Symptoms and Disease Impacts in Adults With Moderate-to-Severe Atopic Dermatitis: Results From a Phase 2b Study With Abrocitinib.,"BACKGROUND Moderate-to-severe atopic dermatitis (AD) is inadequately controlled with current treatments for many patients. Abrocitinib is an oral Janus kinase 1 selective inhibitor under investigation for the treatment of AD. OBJECTIVE The aim of the study was to evaluate patient-reported outcomes in a phase 2b study of abrocitinib in adults with moderate-to-severe AD inadequately controlled by topical therapy (NCT02780167). METHODS Patients (N = 267) were randomly assigned 1:1:1:1:1 to 12-week, once-daily abrocitinib (200, 100, 30, 10 mg) or placebo. Patient-reported outcomes included pruritus numeric rating scale (average), Patient Global Assessment, Patient-Oriented Eczema Measure, Pruritus and Symptoms Assessment for AD, Dermatology Life Quality Index, and Hospital Anxiety and Depression Scale (HADS). RESULTS Abrocitinib 200 or 100 mg resulted in significantly greater improvements from baseline versus placebo in peak pruritus numeric rating scale (by days 2 and 3, respectively), Patient-Oriented Eczema Measure, Pruritus and Symptoms Assessment for AD, Dermatology Life Quality Index, and HADS (200 mg only, by week 1 or 2), and proportions of the patients with Patient Global Assessment clear/almost clear with 2-point or greater improvement (by weeks 1 and 4, respectively) that continued through week 12 (except HADS). CONCLUSIONS Abrocitinib treatment resulted in rapid (2 days to 2 weeks) and persistent improvements in AD symptoms and impacts in moderate-to-severe disease.",2021,"Abrocitinib 200 or 100 mg resulted in significantly greater improvements from baseline versus placebo in peak pruritus numeric rating scale (by days 2 and 3, respectively), Patient-Oriented Eczema Measure, Pruritus and Symptoms Assessment for AD, Dermatology Life Quality Index, and HADS (200 mg only, by week 1 or 2), and proportions of the patients with Patient Global Assessment clear/almost clear with 2-point or greater improvement (by weeks 1 and 4, respectively) that continued through week 12 (except HADS). ","['Moderate-to-severe atopic dermatitis (AD', 'Adults With Moderate-to-Severe Atopic Dermatitis', 'Patients (N = 267', 'adults with moderate-to-severe AD']",['placebo'],"['peak pruritus numeric rating scale', 'pruritus numeric rating scale (average), Patient Global Assessment, Patient-Oriented Eczema Measure, Pruritus and Symptoms Assessment for AD, Dermatology Life Quality Index, and Hospital Anxiety and Depression Scale (HADS', 'Patient-Oriented Eczema Measure, Pruritus and Symptoms Assessment for AD, Dermatology Life Quality Index, and HADS']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517672', 'cui_str': '267'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4304942', 'cui_str': 'POEM - Patient-Oriented Eczema Measure'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}]",267.0,0.315373,"Abrocitinib 200 or 100 mg resulted in significantly greater improvements from baseline versus placebo in peak pruritus numeric rating scale (by days 2 and 3, respectively), Patient-Oriented Eczema Measure, Pruritus and Symptoms Assessment for AD, Dermatology Life Quality Index, and HADS (200 mg only, by week 1 or 2), and proportions of the patients with Patient Global Assessment clear/almost clear with 2-point or greater improvement (by weeks 1 and 4, respectively) that continued through week 12 (except HADS). ","[{'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'From the Oregon Health and Science University, Portland Ludwig Maximilian University, Munich, Germany Innovaderm Research, Montreal, Quebec, Canada The George Washington University School of Medicine and Health Sciences, Washington, DC Pfizer Inc, Groton, CT Pfizer Inc, Collegeville, PA Pfizer Inc, Cambridge, MA Pfizer Inc, New York, NY.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wollenberg', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bissonnette', 'Affiliation': ''}, {'ForeName': 'Jonathan I', 'Initials': 'JI', 'LastName': 'Silverberg', 'Affiliation': ''}, {'ForeName': 'Jocelyne', 'Initials': 'J', 'LastName': 'Papacharalambous', 'Affiliation': ''}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Jean S', 'Initials': 'JS', 'LastName': 'Beebe', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Vincent', 'Affiliation': ''}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Peeva', 'Affiliation': ''}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Bushmakin', 'Affiliation': ''}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Cappelleri', 'Affiliation': ''}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Vanja', 'Initials': 'V', 'LastName': 'Sikirica', 'Affiliation': ''}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Xenakis', 'Affiliation': ''}]","Dermatitis : contact, atopic, occupational, drug",['10.1097/DER.0000000000000725'] 2697,33795545,Colonic Gene Expression and Fecal Microbiota in Diarrhea-predominant Irritable Bowel Syndrome: Increased Toll-like Receptor 4 but Minimal Inflammation and no Response to Mesalazine.,"Background/Aims Diarrhea-predominant irritable bowel syndrome (IBS-D) has been previously associated with evidence of immune activation and altered microbiota. Our aim is to assess the effect of the anti-inflammatory agent, mesalazine, on inflammatory gene expression and microbiota composition in IBS-D. Methods We studied a subset of patients (n = 43) from a previously published 12-week radomized placebo-controlled trial of mesalazine. Mucosal biopsies were assessed by immunohistochemistry and reverse transcription-polymerase chain reaction for a range of markers of inflammation, altered permeability, and sensory receptors including Toll-like receptors (TLRs) at randomization after treatment. All biopsy data were compared to 21 healthy controls. Patient's stool microbiota composition was analysed through 16S ribosomal RNA sequencing. Results We found no evidence of increased immune activation compared to healthy controls. However, we did find increased expression of receptors in both sensory pathways and innate immune response including TLR4. Higher TLR4 expression was associated with greater urgency. TLR4 expression correlated strongly with the expression of the receptors bradykinin receptor B2, chemerin chemokine-like receptor 1, and transient receptor potential cation channel, subfamily A, member 1 as well as TLR4's downstream adaptor myeloid differentiation factor 88. Mesalazine had minimal effect on either gene expression or microbiota composition. Conclusions Biopsies from a well-characterized IBS-D cohort showed no substantial inflammation. Mesalazine has little effect on gene expression and its previous reported effect on fecal microbiota associated with much greater inflammation found in inflammatory bowel diseases is likely secondary to reduced inflammation. Increased expression of TLR4 and correlated receptors in IBS may mediate a general increase in sensitivity to external stimuli, particularly those that signal via the TLR system.",2021,"TLR4 expression correlated strongly with the expression of the receptors bradykinin receptor B2, chemerin chemokine-like receptor 1, and transient receptor potential cation channel, subfamily A, member 1 as well as TLR4's downstream adaptor myeloid differentiation factor 88.","['subset of patients (n = 43) from a previously published 12-week radomized', 'Diarrhea-predominant Irritable Bowel Syndrome', '21 healthy controls']","['Mesalazine', 'placebo', 'mesalazine']","['gene expression or microbiota composition', ""Patient's stool microbiota composition"", 'Higher TLR4 expression', 'TLR4 expression', 'Colonic Gene Expression and Fecal Microbiota', 'immune activation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034037', 'cui_str': 'Publishing'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1262211', 'cui_str': 'Diarrhoea predominant irritable bowel syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0127615', 'cui_str': 'mesalamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1321919', 'cui_str': 'TLR4 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0439662', 'cui_str': 'Immune'}]",,0.054106,"TLR4 expression correlated strongly with the expression of the receptors bradykinin receptor B2, chemerin chemokine-like receptor 1, and transient receptor potential cation channel, subfamily A, member 1 as well as TLR4's downstream adaptor myeloid differentiation factor 88.","[{'ForeName': 'Jonna', 'Initials': 'J', 'LastName': 'Jalanka', 'Affiliation': 'Human Microbiome Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Ching', 'Initials': 'C', 'LastName': 'Lam', 'Affiliation': 'Nottingham Digestive Diseases Center and NIHR Nottingham Biomedical Research Center at Nottingham University Hospitals NHS Trust, the University of Nottingham, Nottingham, Notts, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bennett', 'Affiliation': 'Nottingham Digestive Diseases Center and NIHR Nottingham Biomedical Research Center at Nottingham University Hospitals NHS Trust, the University of Nottingham, Nottingham, Notts, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hartikainen', 'Affiliation': 'Human Microbiome Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Crispie', 'Affiliation': 'Teagasc Food Research Center, Moorepark, Fermoy, Co. Cork, Ireland.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Finnegan', 'Affiliation': 'Teagasc Food Research Center, Moorepark, Fermoy, Co. Cork, Ireland.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Cotter', 'Affiliation': 'Teagasc Food Research Center, Moorepark, Fermoy, Co. Cork, Ireland.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Spiller', 'Affiliation': 'Nottingham Digestive Diseases Center and NIHR Nottingham Biomedical Research Center at Nottingham University Hospitals NHS Trust, the University of Nottingham, Nottingham, Notts, UK.'}]",Journal of neurogastroenterology and motility,['10.5056/jnm20205'] 2698,33795542,Efficacy of S-pantoprazole 10 mg in the Symptom Control of Non-erosive Reflux Disease: A Phase III Placebo-controlled Trial.,"Background/Aims S-isomer (S) pantoprazole is more bioavailable and less dependent on cytochrome 2C19 than is racemic pantoprazole. We aim to evaluate the efficacy and safety of 10 mg S-pantoprazole for treatment of non-erosive reflux disease (NERD). Methods In this phase 3, double-blind, randomized placebo controlled, multicenter study, 174 NERD patients were randomized to one of both treatment groups: 10 mg S-pantoprazole, or placebo once daily for 4 weeks. Symptoms and safety were assessed. The efficacy endpoints were complete relief of symptoms, > 50% improvement of all reflux symptoms and recurrence. Results Eighty-eight patients were assigned to the S-pantoprazole group (25 males, mean 43.7 years old) and 86 to the placebo group (32 males, mean 43.0 years old), and 163 patients were subjected to full Analysis Set. A higher proportion of patients in the S-pantoprazole group had complete symptom relief (42.0 % [34/81] vs 17.1% [14/82], P < 0.001) and > 50% symptom responses (66.0% vs 50.0%, P = 0.010 for heartburn; 64.2% vs 28.0%, P = 0.010 for acid regurgitation; and 51.9% vs 30.5%, P = 0.03 for epigastric discomfort) compared to the placebo group. The factors associated with poor responsiveness to PPI were older age, female, greater body mass index, and severe baseline symptoms. Conclusions Low dose of S-pantoprazole (10 mg) for 4 weeks was more efficacious than placebo in providing reflux symptom relief in patients with NERD, especially acid regurgitation. More doses or longer periods of treatment with S-pantoprazole would be needed to completely eliminate symptoms.",2021,"A higher proportion of patients in the S-pantoprazole group had complete symptom relief (42.0 % [34/81] vs 17.1% [14/82], P < 0.001) and > 50% symptom responses (66.0% vs 50.0%, P = 0.010 for heartburn; 64.2% vs 28.0%, P = 0.010 for acid regurgitation; and 51.9% vs 30.5%, P = 0.03 for epigastric discomfort) compared to the placebo group.","['patients with NERD, especially acid regurgitation', 'non-erosive reflux disease (NERD', '174 NERD patients', 'Non-erosive Reflux Disease', 'group (25 males, mean 43.7 years old) and 86 to the placebo group (32 males, mean 43.0 years old), and 163 patients', 'Eighty-eight patients']","['racemic pantoprazole', 'placebo', 'pantoprazole', '/Aims\n\n\nS-isomer (S) pantoprazole', 'S-pantoprazole', '10 mg S-pantoprazole', '10 mg S-pantoprazole, or placebo']","['Symptoms and safety', 'complete symptom relief', 'efficacy and safety', 'reflux symptoms and recurrence', 'reflux symptom relief']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2242528', 'cui_str': 'Non-erosive reflux disease'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0232605', 'cui_str': 'Regurgitates after swallowing'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517898', 'cui_str': '88'}]","[{'cui': 'C0081876', 'cui_str': 'pantoprazole'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",174.0,0.419405,"A higher proportion of patients in the S-pantoprazole group had complete symptom relief (42.0 % [34/81] vs 17.1% [14/82], P < 0.001) and > 50% symptom responses (66.0% vs 50.0%, P = 0.010 for heartburn; 64.2% vs 28.0%, P = 0.010 for acid regurgitation; and 51.9% vs 30.5%, P = 0.03 for epigastric discomfort) compared to the placebo group.","[{'ForeName': 'Yu Kyung', 'Initials': 'YK', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, The Catholic University of Korea, College of Medicine, Seoul, Korea.'}, {'ForeName': 'Myung-Gyu', 'Initials': 'MG', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, The Catholic University of Korea, College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyojin', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Ji Won', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Boramae Medical Center, Seoul National University of College of Medicine, Seoul, Korea.'}, {'ForeName': 'Dong Ho', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Digestive Disease Center, CHA Bundang Medical Center, CHA University, Seongnam, Gyeonggi-do, Korea.'}, {'ForeName': 'Kwang Hyun', 'Initials': 'KH', 'LastName': 'Ko', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Gyeonggi-do, Korea.'}, {'ForeName': 'Sang Gyun', 'Initials': 'SG', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hwoon-Yong', 'Initials': 'HY', 'LastName': 'Jung', 'Affiliation': 'Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Su Jin', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Digestive Disease Center and Research Institute, Department of Internal Medicine, Soonchunhyang University College of Medicine, Bucheon, Gyeonggi-do, Korea.'}, {'ForeName': 'Yong Chan', 'Initials': 'YC', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Si Hyung', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea.'}]",Journal of neurogastroenterology and motility,['10.5056/jnm19053'] 2699,33794587,"Effects of an Integrated Exercise Program Including ""Functional"" Inspiratory Muscle Training in Geriatric Individuals with and without Chronic Obstructive Pulmonary Disease.","BACKGROUND Inspiratory muscle training (IMT) is a commonly used exercise method for both patients with chronic obstructive pulmonary disease (COPD) and the older adult population. In addition to their primary function, respiratory muscles play an active role in core stabilization. However, no IMT program includes both of these functions (i.e., core stabilization and postural control functions as well as respiration). This study investigated the effects of a newly integrated exercise program, termed ""functional IMT,"" in geriatric individuals with and without COPD. METHODS This prospective and experimental study included 45 geriatric individuals with COPD (n=22) and without COPD (n=23). The training program consisted of 4 weeks of conventional IMT followed by 4 weeks of functional IMT. Respiratory muscle strength, symptoms, exercise capacity, balance, postural control, physical activity, and quality of life were evaluated. RESULTS After training, respiratory muscle strength, symptoms, exercise capacity, balance, postural control, and quality of life improved in both groups (p<0.05). In addition, physical activity was increased in the COPD group (p<0.05). We observed no statistically significant difference in outcomes between the two groups before and after treatment (p>0.05). CONCLUSION The gains were similar in both groups. Functional IMT, which is an integrated approach that includes all respiratory muscle functions, is a safe, effective, and innovative method for use in geriatric individuals with and without COPD.",2021,"After training, respiratory muscle strength, symptoms, exercise capacity, balance, postural control, and quality of life improved in both groups (p<0.05).","['Geriatric Individuals with and without Chronic Obstructive Pulmonary Disease', '45 geriatric individuals with COPD (n=22) and without COPD (n=23', 'patients with chronic obstructive pulmonary disease (COPD) and the older adult population', 'geriatric individuals with and without COPD']","['Inspiratory muscle training (IMT', 'conventional IMT followed by 4 weeks of functional IMT', 'newly integrated exercise program', 'Integrated Exercise Program Including ""Functional"" Inspiratory Muscle Training']","['Respiratory muscle strength, symptoms, exercise capacity, balance, postural control, physical activity, and quality of life', 'physical activity', 'respiratory muscle strength, symptoms, exercise capacity, balance, postural control, and quality of life']","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",45.0,0.00480386,"After training, respiratory muscle strength, symptoms, exercise capacity, balance, postural control, and quality of life improved in both groups (p<0.05).","[{'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Ozsoy', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Selcuk University, Konya, Turkey.'}, {'ForeName': 'Buse Ozcan', 'Initials': 'BO', 'LastName': 'Kahraman', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Dokuz Eylul University, Izmir, Turkey.'}, {'ForeName': 'Gulsah', 'Initials': 'G', 'LastName': 'Ozsoy', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Selcuk University, Konya, Turkey.'}, {'ForeName': 'Nursen', 'Initials': 'N', 'LastName': 'Ilcin', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Dokuz Eylul University, Izmir, Turkey.'}, {'ForeName': 'Nil', 'Initials': 'N', 'LastName': 'Tekin', 'Affiliation': 'Narlidere Nursing Home Elderly Care and Rehabilitation Center, Izmir, Turkey.'}, {'ForeName': 'Sema', 'Initials': 'S', 'LastName': 'Savci', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Dokuz Eylul University, Izmir, Turkey.'}]",Annals of geriatric medicine and research,['10.4235/agmr.21.0014'] 2700,33794570,"A randomized prospective study comparing acute toxicity, compliance and objective response rate between simultaneous integrated boost and sequential intensity-modulated radiotherapy for locally advanced head and neck cancer.","PURPOSE Intensity-modulated radiotherapy (IMRT) provides higher dose to target volumes and limits the dose to normal tissues. IMRT may be applied using either simultaneous integrated boost (SIB-IMRT) or sequential boost (SEQ-IMRT) technique. The objectives of this study were to compare acute toxicity and objective response rates between SIB-IMRT and SEQ-IMRT in patients with locally advanced head and neck cancer. MATERIALS AND METHODS Total 110 patients with locally advanced carcinoma of oropharynx, hypopharynx, and larynx were randomized equally into the two arms (SIB-IMRT vs. SEQ-IMRT). Patients in SIB-IMRT arm received dose of 66 Gy in 30 fractions, 5 days a week, over 6 weeks. SEQ-IMRT arm's patients received 70 Gy in 35 fractions over 7 weeks. Weekly concurrent cisplatin chemotherapy was given in both arms. Patients were assessed for acute toxicities during the treatment and for objective response at 3 months after the radiotherapy. RESULTS Grade 3 dysphagia was significantly more with SIB-IMRT compared to SEQ-IMRT (72% vs. 41.2%; p = 0.006) but other toxicities including mucositis, dermatitis, xerostomia, weight-loss, incidence of nasogastric tube intubation and hospitalization for supportive management were similar in both the arms. Patients in SIB-IMRT arm showed better treatment-compliance and had significantly less treatment-interruption compared to SEQ-IMRT arm (p = 0.028). Objective response rates were similar in both the arms (p = 0.783). CONCLUSION Concurrent chemoradiation with SIB-IMRT for locally advanced head and neck cancer is well-tolerated and results in better treatment-compliance, similar objective response rates, comparable incidence of mucositis and higher incidence of grade 3 dysphagia compared to SEQ-IMRT.",2021,Patients in SIB-IMRT arm showed better treatment-compliance and had significantly less treatment-interruption compared to SEQ-IMRT arm (p = 0.028).,"['Total 110 patients with locally advanced carcinoma of oropharynx, hypopharynx, and larynx', 'locally advanced head and neck cancer', 'patients with locally advanced head and neck cancer']","['IMRT', 'SIB-IMRT and SEQ-IMRT', 'SIB-IMRT', 'simultaneous integrated boost and sequential intensity-modulated radiotherapy', 'cisplatin chemotherapy', 'simultaneous integrated boost (SIB-IMRT) or sequential boost (SEQ-IMRT) technique', 'Intensity-modulated radiotherapy (IMRT']","['acute toxicity and objective response rates', 'Grade 3 dysphagia', 'acute toxicity, compliance and objective response rate', 'acute toxicities', 'toxicities including mucositis, dermatitis, xerostomia, weight-loss, incidence of nasogastric tube intubation and hospitalization for supportive management', 'Objective response rates']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2349952', 'cui_str': 'Oropharyngeal cancer'}, {'cui': 'C0020629', 'cui_str': 'Hypopharyngeal structure'}, {'cui': 'C0023051', 'cui_str': 'Disorder of the larynx'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0085678', 'cui_str': 'Nasogastric tube'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",110.0,0.0112828,Patients in SIB-IMRT arm showed better treatment-compliance and had significantly less treatment-interruption compared to SEQ-IMRT arm (p = 0.028).,"[{'ForeName': 'Akanksha', 'Initials': 'A', 'LastName': 'Grover', 'Affiliation': 'Department of Radiation Oncology, Bhagwan Mahaveer Cancer Hospital and Research Centre, Jaipur, Rajasthan, India.'}, {'ForeName': 'Tej Prakash', 'Initials': 'TP', 'LastName': 'Soni', 'Affiliation': 'Department of Radiation Oncology, Bhagwan Mahaveer Cancer Hospital and Research Centre, Jaipur, Rajasthan, India.'}, {'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Patni', 'Affiliation': 'Department of Radiation Oncology, Bhagwan Mahaveer Cancer Hospital and Research Centre, Jaipur, Rajasthan, India.'}, {'ForeName': 'Dinesh Kumar', 'Initials': 'DK', 'LastName': 'Singh', 'Affiliation': 'Department of Radiation Oncology, Bhagwan Mahaveer Cancer Hospital and Research Centre, Jaipur, Rajasthan, India.'}, {'ForeName': 'Naresh', 'Initials': 'N', 'LastName': 'Jakhotia', 'Affiliation': 'Department of Radiation Oncology, Bhagwan Mahaveer Cancer Hospital and Research Centre, Jaipur, Rajasthan, India.'}, {'ForeName': 'Anil Kumar', 'Initials': 'AK', 'LastName': 'Gupta', 'Affiliation': 'Department of Surgical Oncology, Bhagwan Mahaveer Cancer Hospital and Research Centre, Jaipur, Rajasthan, India.'}, {'ForeName': 'Lalit Mohan', 'Initials': 'LM', 'LastName': 'Sharma', 'Affiliation': 'Department of Medical Oncology, Bhagwan Mahaveer Cancer Hospital and Research Centre, Jaipur, Rajasthan, India.'}, {'ForeName': 'Shantanu', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Radiotherapy, S.M.S Medical College and Hospital, Jaipur, Rajasthan, India.'}, {'ForeName': 'Ravindra Singh', 'Initials': 'RS', 'LastName': 'Gothwal', 'Affiliation': 'Department of Radiotherapy, S.M.S Medical College and Hospital, Jaipur, Rajasthan, India.'}]",Radiation oncology journal,['10.3857/roj.2020.01018'] 2701,33730454,Two Randomized Trials of Neutralizing Antibodies to Prevent HIV-1 Acquisition.,"BACKGROUND Whether a broadly neutralizing antibody (bnAb) can be used to prevent human immunodeficiency virus type 1 (HIV-1) acquisition is unclear. METHODS We enrolled at-risk cisgender men and transgender persons in the Americas and Europe in the HVTN 704/HPTN 085 trial and at-risk women in sub-Saharan Africa in the HVTN 703/HPTN 081 trial. Participants were randomly assigned to receive, every 8 weeks, infusions of a bnAb (VRC01) at a dose of either 10 or 30 mg per kilogram (low-dose group and high-dose group, respectively) or placebo, for 10 infusions in total. HIV-1 testing was performed every 4 weeks. The VRC01 80% inhibitory concentration (IC 80 ) of acquired isolates was measured with the TZM-bl assay. RESULTS Adverse events were similar in number and severity among the treatment groups within each trial. Among the 2699 participants in HVTN 704/HPTN 085, HIV-1 infection occurred in 32 in the low-dose group, 28 in the high-dose group, and 38 in the placebo group. Among the 1924 participants in HVTN 703/HPTN 081, infection occurred in 28 in the low-dose group, 19 in the high-dose group, and 29 in the placebo group. The incidence of HIV-1 infection per 100 person-years in HVTN 704/HPTN 085 was 2.35 in the pooled VRC01 groups and 2.98 in the placebo group (estimated prevention efficacy, 26.6%; 95% confidence interval [CI], -11.7 to 51.8; P = 0.15), and the incidence per 100 person-years in HVTN 703/HPTN 081 was 2.49 in the pooled VRC01 groups and 3.10 in the placebo group (estimated prevention efficacy, 8.8%; 95% CI, -45.1 to 42.6; P = 0.70). In prespecified analyses pooling data across the trials, the incidence of infection with VRC01-sensitive isolates (IC 80 <1 μg per milliliter) per 100 person-years was 0.20 among VRC01 recipients and 0.86 among placebo recipients (estimated prevention efficacy, 75.4%; 95% CI, 45.5 to 88.9). The prevention efficacy against sensitive isolates was similar for each VRC01 dose and trial; VRC01 did not prevent acquisition of other HIV-1 isolates. CONCLUSIONS VRC01 did not prevent overall HIV-1 acquisition more effectively than placebo, but analyses of VRC01-sensitive HIV-1 isolates provided proof-of-concept that bnAb prophylaxis can be effective. (Supported by the National Institute of Allergy and Infectious Diseases; HVTN 704/HPTN 085 and HVTN 703/HPTN 081 ClinicalTrials.gov numbers, NCT02716675 and NCT02568215.).",2021,"The prevention efficacy against sensitive isolates was similar for each VRC01 dose and trial; VRC01 did not prevent acquisition of other HIV-1 isolates. ","['2699 participants in HVTN 704/HPTN 085', 'enrolled at-risk cisgender men and transgender persons in the Americas and Europe in the HVTN 704/HPTN 085 trial and at-risk women in sub-Saharan Africa in the HVTN 703/HPTN 081 trial', '1924 participants in HVTN 703/HPTN 081']","['placebo', 'Neutralizing Antibodies']","['incidence of infection with VRC01-sensitive isolates', 'HIV-1 infection', 'HIV-1 Acquisition', 'infection', 'incidence of HIV-1 infection', 'overall HIV-1 acquisition', 'VRC01 80% inhibitory concentration (IC 80 ) of acquired isolates', 'HIV-1']","[{'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3266856', 'cui_str': 'Transgendered Persons'}, {'cui': 'C0002454', 'cui_str': 'America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}]",2699.0,0.456943,"The prevention efficacy against sensitive isolates was similar for each VRC01 dose and trial; VRC01 did not prevent acquisition of other HIV-1 isolates. ","[{'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Corey', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Gilbert', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Juraska', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Montefiori', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Morris', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'Shelly T', 'Initials': 'ST', 'LastName': 'Karuna', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'Srilatha', 'Initials': 'S', 'LastName': 'Edupuganti', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'Nyaradzo M', 'Initials': 'NM', 'LastName': 'Mgodi', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'Allan C', 'Initials': 'AC', 'LastName': 'deCamp', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Rudnicki', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'Yunda', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Gonzales', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'Robinson', 'Initials': 'R', 'LastName': 'Cabello', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Orrell', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'Javier R', 'Initials': 'JR', 'LastName': 'Lama', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Laher', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'Erica M', 'Initials': 'EM', 'LastName': 'Lazarus', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Sanchez', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Frank', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Hinojosa', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'Magdalena E', 'Initials': 'ME', 'LastName': 'Sobieszczyk', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'Kyle E', 'Initials': 'KE', 'LastName': 'Marshall', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'Pamela G', 'Initials': 'PG', 'LastName': 'Mukwekwerere', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Makhema', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'Lindsey R', 'Initials': 'LR', 'LastName': 'Baden', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'James I', 'Initials': 'JI', 'LastName': 'Mullins', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Williamson', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hural', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'M Juliana', 'Initials': 'MJ', 'LastName': 'McElrath', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'Carter', 'Initials': 'C', 'LastName': 'Bentley', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'Simbarashe', 'Initials': 'S', 'LastName': 'Takuva', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'Margarita M', 'Initials': 'MM', 'LastName': 'Gomez Lorenzo', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'David N', 'Initials': 'DN', 'LastName': 'Burns', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Espy', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'April K', 'Initials': 'AK', 'LastName': 'Randhawa', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Kochar', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Piwowar-Manning', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Donnell', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'Nirupama', 'Initials': 'N', 'LastName': 'Sista', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Andrew', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Kublin', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'Glenda', 'Initials': 'G', 'LastName': 'Gray', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Ledgerwood', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Mascola', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': 'Myron S', 'Initials': 'MS', 'LastName': 'Cohen', 'Affiliation': ""From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2031738'] 2702,33730455,Pegcetacoplan versus Eculizumab in Paroxysmal Nocturnal Hemoglobinuria.,"BACKGROUND Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, acquired disease characterized by chronic complement-mediated hemolysis. C5 inhibition controls intravascular hemolysis in untreated PNH but cannot address extravascular hemolysis. Pegcetacoplan, a pegylated peptide targeting proximal complement protein C3, potentially inhibits both intravascular and extravascular hemolysis. METHODS We conducted a phase 3 open-label, controlled trial to assess the efficacy and safety of pegcetacoplan as compared with eculizumab in adults with PNH and hemoglobin levels lower than 10.5 g per deciliter despite eculizumab therapy. After a 4-week run-in phase in which all patients received pegcetacoplan plus eculizumab, we randomly assigned patients to subcutaneous pegcetacoplan monotherapy (41 patients) or intravenous eculizumab (39 patients). The primary end point was the mean change in hemoglobin level from baseline to week 16. Additional clinical and hematologic markers of hemolysis and safety were assessed. RESULTS Pegcetacoplan was superior to eculizumab with respect to the change in hemoglobin level from baseline to week 16, with an adjusted (least squares) mean difference of 3.84 g per deciliter (P<0.001). A total of 35 patients (85%) receiving pegcetacoplan as compared with 6 patients (15%) receiving eculizumab no longer required transfusions. Noninferiority of pegcetacoplan to eculizumab was shown for the change in absolute reticulocyte count but not for the change in lactate dehydrogenase level. Functional Assessment of Chronic Illness Therapy-Fatigue scores improved from baseline in the pegcetacoplan group. The most common adverse events that occurred during treatment in the pegcetacoplan and eculizumab groups were injection site reactions (37% vs. 3%), diarrhea (22% vs. 3%), breakthrough hemolysis (10% vs. 23%), headache (7% vs. 23%), and fatigue (5% vs. 15%). There were no cases of meningitis in either group. CONCLUSIONS Pegcetacoplan was superior to eculizumab in improving hemoglobin and clinical and hematologic outcomes in patients with PNH by providing broad hemolysis control, including control of intravascular and extravascular hemolysis. (Funded by Apellis Pharmaceuticals; PEGASUS ClinicalTrials.gov, NCT03500549.).",2021,"The most common adverse events that occurred during treatment in the pegcetacoplan and eculizumab groups were injection site reactions (37% vs. 3%), diarrhea (22% vs. 3%), breakthrough hemolysis (10% vs. 23%), headache (7% vs. 23%), and fatigue (5% vs. 15%).","['patients with PNH', 'adults with PNH and hemoglobin levels lower than 10.5 g per deciliter despite eculizumab therapy', 'Paroxysmal Nocturnal Hemoglobinuria']","['Pegcetacoplan', 'pegcetacoplan', 'Pegcetacoplan versus Eculizumab', 'pegcetacoplan to eculizumab', 'pegcetacoplan plus eculizumab', 'subcutaneous pegcetacoplan monotherapy', 'eculizumab', 'intravenous eculizumab']","['hemoglobin level', 'hemoglobin and clinical and hematologic outcomes', 'eculizumab no longer required transfusions', 'Functional Assessment of Chronic Illness Therapy-Fatigue scores', 'headache', 'fatigue', 'diarrhea', 'breakthrough hemolysis', 'efficacy and safety', 'injection site reactions', 'mean change in hemoglobin level', 'absolute reticulocyte count']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024790', 'cui_str': 'Paroxysmal nocturnal hemoglobinuria'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0439241', 'cui_str': 'dL'}, {'cui': 'C1541483', 'cui_str': 'eculizumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1541483', 'cui_str': 'eculizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1541483', 'cui_str': 'eculizumab'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0444503', 'cui_str': 'Breakthrough'}, {'cui': 'C0019054', 'cui_str': 'Haemolysis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0206161', 'cui_str': 'Reticulocyte count'}]",35.0,0.174053,"The most common adverse events that occurred during treatment in the pegcetacoplan and eculizumab groups were injection site reactions (37% vs. 3%), diarrhea (22% vs. 3%), breakthrough hemolysis (10% vs. 23%), headache (7% vs. 23%), and fatigue (5% vs. 15%).","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillmen', 'Affiliation': ""From the Department of Haematology, St. James's University Hospital, Leeds (P.H., M.G.), and Lisa Tan Pharma Consulting, Cambridge (L.T.) - both in the United Kingdom; the Department of Clinical Haematology, Peter MacCallum Cancer Center and Royal Melbourne Hospital, Melbourne, VIC, Australia (J.S.); Jane Anne Nohl Division of Hematology, Keck School of Medicine of USC, Los Angeles (I.W.); the Department of Hematology, West German Cancer Center University Hospital Essen, University of Duisburg-Essen, Essen (A. Röth), the Institute of Transfusion Medicine, University of Ulm and Institute of Clinical Transfusion Medicine and Immunogenetics, German Red Cross Blood Transfusion Service and University Hospital Ulm, Ulm (B.H.), and the Department of Oncology, Hematology, Hemostaseology and Stem Cell Transplantation, University Hospital RWTH Aachen, Aachen (J.P.) - all in Germany; the Department of Hematology, NTT Medical Center Tokyo, Tokyo (K.U.), and the Department of Hematology and Oncology, Okayama University Hospital, Okayama (H.N.) - both in Japan; Centre d'Investigations Cliniques (J.-J.K.) and the French Reference Center for Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria (R.P.T.), Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Université de Paris, Paris; the Department of Medicine, Division of Hematologic Malignancies and Cellular Therapy, Duke University, Durham, NC (C.C.); Apellis Pharmaceuticals, Waltham, MA (M.H., P.D., C.F., F.G., T.A.); and the Hematology and BMT Unit, AORN San Giuseppe Moscati, Avellino, Italy (A. Risitano).""}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Szer', 'Affiliation': ""From the Department of Haematology, St. James's University Hospital, Leeds (P.H., M.G.), and Lisa Tan Pharma Consulting, Cambridge (L.T.) - both in the United Kingdom; the Department of Clinical Haematology, Peter MacCallum Cancer Center and Royal Melbourne Hospital, Melbourne, VIC, Australia (J.S.); Jane Anne Nohl Division of Hematology, Keck School of Medicine of USC, Los Angeles (I.W.); the Department of Hematology, West German Cancer Center University Hospital Essen, University of Duisburg-Essen, Essen (A. Röth), the Institute of Transfusion Medicine, University of Ulm and Institute of Clinical Transfusion Medicine and Immunogenetics, German Red Cross Blood Transfusion Service and University Hospital Ulm, Ulm (B.H.), and the Department of Oncology, Hematology, Hemostaseology and Stem Cell Transplantation, University Hospital RWTH Aachen, Aachen (J.P.) - all in Germany; the Department of Hematology, NTT Medical Center Tokyo, Tokyo (K.U.), and the Department of Hematology and Oncology, Okayama University Hospital, Okayama (H.N.) - both in Japan; Centre d'Investigations Cliniques (J.-J.K.) and the French Reference Center for Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria (R.P.T.), Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Université de Paris, Paris; the Department of Medicine, Division of Hematologic Malignancies and Cellular Therapy, Duke University, Durham, NC (C.C.); Apellis Pharmaceuticals, Waltham, MA (M.H., P.D., C.F., F.G., T.A.); and the Hematology and BMT Unit, AORN San Giuseppe Moscati, Avellino, Italy (A. Risitano).""}, {'ForeName': 'Ilene', 'Initials': 'I', 'LastName': 'Weitz', 'Affiliation': ""From the Department of Haematology, St. James's University Hospital, Leeds (P.H., M.G.), and Lisa Tan Pharma Consulting, Cambridge (L.T.) - both in the United Kingdom; the Department of Clinical Haematology, Peter MacCallum Cancer Center and Royal Melbourne Hospital, Melbourne, VIC, Australia (J.S.); Jane Anne Nohl Division of Hematology, Keck School of Medicine of USC, Los Angeles (I.W.); the Department of Hematology, West German Cancer Center University Hospital Essen, University of Duisburg-Essen, Essen (A. Röth), the Institute of Transfusion Medicine, University of Ulm and Institute of Clinical Transfusion Medicine and Immunogenetics, German Red Cross Blood Transfusion Service and University Hospital Ulm, Ulm (B.H.), and the Department of Oncology, Hematology, Hemostaseology and Stem Cell Transplantation, University Hospital RWTH Aachen, Aachen (J.P.) - all in Germany; the Department of Hematology, NTT Medical Center Tokyo, Tokyo (K.U.), and the Department of Hematology and Oncology, Okayama University Hospital, Okayama (H.N.) - both in Japan; Centre d'Investigations Cliniques (J.-J.K.) and the French Reference Center for Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria (R.P.T.), Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Université de Paris, Paris; the Department of Medicine, Division of Hematologic Malignancies and Cellular Therapy, Duke University, Durham, NC (C.C.); Apellis Pharmaceuticals, Waltham, MA (M.H., P.D., C.F., F.G., T.A.); and the Hematology and BMT Unit, AORN San Giuseppe Moscati, Avellino, Italy (A. Risitano).""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Röth', 'Affiliation': ""From the Department of Haematology, St. James's University Hospital, Leeds (P.H., M.G.), and Lisa Tan Pharma Consulting, Cambridge (L.T.) - both in the United Kingdom; the Department of Clinical Haematology, Peter MacCallum Cancer Center and Royal Melbourne Hospital, Melbourne, VIC, Australia (J.S.); Jane Anne Nohl Division of Hematology, Keck School of Medicine of USC, Los Angeles (I.W.); the Department of Hematology, West German Cancer Center University Hospital Essen, University of Duisburg-Essen, Essen (A. Röth), the Institute of Transfusion Medicine, University of Ulm and Institute of Clinical Transfusion Medicine and Immunogenetics, German Red Cross Blood Transfusion Service and University Hospital Ulm, Ulm (B.H.), and the Department of Oncology, Hematology, Hemostaseology and Stem Cell Transplantation, University Hospital RWTH Aachen, Aachen (J.P.) - all in Germany; the Department of Hematology, NTT Medical Center Tokyo, Tokyo (K.U.), and the Department of Hematology and Oncology, Okayama University Hospital, Okayama (H.N.) - both in Japan; Centre d'Investigations Cliniques (J.-J.K.) and the French Reference Center for Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria (R.P.T.), Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Université de Paris, Paris; the Department of Medicine, Division of Hematologic Malignancies and Cellular Therapy, Duke University, Durham, NC (C.C.); Apellis Pharmaceuticals, Waltham, MA (M.H., P.D., C.F., F.G., T.A.); and the Hematology and BMT Unit, AORN San Giuseppe Moscati, Avellino, Italy (A. Risitano).""}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Höchsmann', 'Affiliation': ""From the Department of Haematology, St. James's University Hospital, Leeds (P.H., M.G.), and Lisa Tan Pharma Consulting, Cambridge (L.T.) - both in the United Kingdom; the Department of Clinical Haematology, Peter MacCallum Cancer Center and Royal Melbourne Hospital, Melbourne, VIC, Australia (J.S.); Jane Anne Nohl Division of Hematology, Keck School of Medicine of USC, Los Angeles (I.W.); the Department of Hematology, West German Cancer Center University Hospital Essen, University of Duisburg-Essen, Essen (A. Röth), the Institute of Transfusion Medicine, University of Ulm and Institute of Clinical Transfusion Medicine and Immunogenetics, German Red Cross Blood Transfusion Service and University Hospital Ulm, Ulm (B.H.), and the Department of Oncology, Hematology, Hemostaseology and Stem Cell Transplantation, University Hospital RWTH Aachen, Aachen (J.P.) - all in Germany; the Department of Hematology, NTT Medical Center Tokyo, Tokyo (K.U.), and the Department of Hematology and Oncology, Okayama University Hospital, Okayama (H.N.) - both in Japan; Centre d'Investigations Cliniques (J.-J.K.) and the French Reference Center for Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria (R.P.T.), Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Université de Paris, Paris; the Department of Medicine, Division of Hematologic Malignancies and Cellular Therapy, Duke University, Durham, NC (C.C.); Apellis Pharmaceuticals, Waltham, MA (M.H., P.D., C.F., F.G., T.A.); and the Hematology and BMT Unit, AORN San Giuseppe Moscati, Avellino, Italy (A. Risitano).""}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Panse', 'Affiliation': ""From the Department of Haematology, St. James's University Hospital, Leeds (P.H., M.G.), and Lisa Tan Pharma Consulting, Cambridge (L.T.) - both in the United Kingdom; the Department of Clinical Haematology, Peter MacCallum Cancer Center and Royal Melbourne Hospital, Melbourne, VIC, Australia (J.S.); Jane Anne Nohl Division of Hematology, Keck School of Medicine of USC, Los Angeles (I.W.); the Department of Hematology, West German Cancer Center University Hospital Essen, University of Duisburg-Essen, Essen (A. Röth), the Institute of Transfusion Medicine, University of Ulm and Institute of Clinical Transfusion Medicine and Immunogenetics, German Red Cross Blood Transfusion Service and University Hospital Ulm, Ulm (B.H.), and the Department of Oncology, Hematology, Hemostaseology and Stem Cell Transplantation, University Hospital RWTH Aachen, Aachen (J.P.) - all in Germany; the Department of Hematology, NTT Medical Center Tokyo, Tokyo (K.U.), and the Department of Hematology and Oncology, Okayama University Hospital, Okayama (H.N.) - both in Japan; Centre d'Investigations Cliniques (J.-J.K.) and the French Reference Center for Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria (R.P.T.), Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Université de Paris, Paris; the Department of Medicine, Division of Hematologic Malignancies and Cellular Therapy, Duke University, Durham, NC (C.C.); Apellis Pharmaceuticals, Waltham, MA (M.H., P.D., C.F., F.G., T.A.); and the Hematology and BMT Unit, AORN San Giuseppe Moscati, Avellino, Italy (A. Risitano).""}, {'ForeName': 'Kensuke', 'Initials': 'K', 'LastName': 'Usuki', 'Affiliation': ""From the Department of Haematology, St. James's University Hospital, Leeds (P.H., M.G.), and Lisa Tan Pharma Consulting, Cambridge (L.T.) - both in the United Kingdom; the Department of Clinical Haematology, Peter MacCallum Cancer Center and Royal Melbourne Hospital, Melbourne, VIC, Australia (J.S.); Jane Anne Nohl Division of Hematology, Keck School of Medicine of USC, Los Angeles (I.W.); the Department of Hematology, West German Cancer Center University Hospital Essen, University of Duisburg-Essen, Essen (A. Röth), the Institute of Transfusion Medicine, University of Ulm and Institute of Clinical Transfusion Medicine and Immunogenetics, German Red Cross Blood Transfusion Service and University Hospital Ulm, Ulm (B.H.), and the Department of Oncology, Hematology, Hemostaseology and Stem Cell Transplantation, University Hospital RWTH Aachen, Aachen (J.P.) - all in Germany; the Department of Hematology, NTT Medical Center Tokyo, Tokyo (K.U.), and the Department of Hematology and Oncology, Okayama University Hospital, Okayama (H.N.) - both in Japan; Centre d'Investigations Cliniques (J.-J.K.) and the French Reference Center for Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria (R.P.T.), Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Université de Paris, Paris; the Department of Medicine, Division of Hematologic Malignancies and Cellular Therapy, Duke University, Durham, NC (C.C.); Apellis Pharmaceuticals, Waltham, MA (M.H., P.D., C.F., F.G., T.A.); and the Hematology and BMT Unit, AORN San Giuseppe Moscati, Avellino, Italy (A. Risitano).""}, {'ForeName': 'Morag', 'Initials': 'M', 'LastName': 'Griffin', 'Affiliation': ""From the Department of Haematology, St. James's University Hospital, Leeds (P.H., M.G.), and Lisa Tan Pharma Consulting, Cambridge (L.T.) - both in the United Kingdom; the Department of Clinical Haematology, Peter MacCallum Cancer Center and Royal Melbourne Hospital, Melbourne, VIC, Australia (J.S.); Jane Anne Nohl Division of Hematology, Keck School of Medicine of USC, Los Angeles (I.W.); the Department of Hematology, West German Cancer Center University Hospital Essen, University of Duisburg-Essen, Essen (A. Röth), the Institute of Transfusion Medicine, University of Ulm and Institute of Clinical Transfusion Medicine and Immunogenetics, German Red Cross Blood Transfusion Service and University Hospital Ulm, Ulm (B.H.), and the Department of Oncology, Hematology, Hemostaseology and Stem Cell Transplantation, University Hospital RWTH Aachen, Aachen (J.P.) - all in Germany; the Department of Hematology, NTT Medical Center Tokyo, Tokyo (K.U.), and the Department of Hematology and Oncology, Okayama University Hospital, Okayama (H.N.) - both in Japan; Centre d'Investigations Cliniques (J.-J.K.) and the French Reference Center for Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria (R.P.T.), Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Université de Paris, Paris; the Department of Medicine, Division of Hematologic Malignancies and Cellular Therapy, Duke University, Durham, NC (C.C.); Apellis Pharmaceuticals, Waltham, MA (M.H., P.D., C.F., F.G., T.A.); and the Hematology and BMT Unit, AORN San Giuseppe Moscati, Avellino, Italy (A. Risitano).""}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Kiladjian', 'Affiliation': ""From the Department of Haematology, St. James's University Hospital, Leeds (P.H., M.G.), and Lisa Tan Pharma Consulting, Cambridge (L.T.) - both in the United Kingdom; the Department of Clinical Haematology, Peter MacCallum Cancer Center and Royal Melbourne Hospital, Melbourne, VIC, Australia (J.S.); Jane Anne Nohl Division of Hematology, Keck School of Medicine of USC, Los Angeles (I.W.); the Department of Hematology, West German Cancer Center University Hospital Essen, University of Duisburg-Essen, Essen (A. Röth), the Institute of Transfusion Medicine, University of Ulm and Institute of Clinical Transfusion Medicine and Immunogenetics, German Red Cross Blood Transfusion Service and University Hospital Ulm, Ulm (B.H.), and the Department of Oncology, Hematology, Hemostaseology and Stem Cell Transplantation, University Hospital RWTH Aachen, Aachen (J.P.) - all in Germany; the Department of Hematology, NTT Medical Center Tokyo, Tokyo (K.U.), and the Department of Hematology and Oncology, Okayama University Hospital, Okayama (H.N.) - both in Japan; Centre d'Investigations Cliniques (J.-J.K.) and the French Reference Center for Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria (R.P.T.), Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Université de Paris, Paris; the Department of Medicine, Division of Hematologic Malignancies and Cellular Therapy, Duke University, Durham, NC (C.C.); Apellis Pharmaceuticals, Waltham, MA (M.H., P.D., C.F., F.G., T.A.); and the Hematology and BMT Unit, AORN San Giuseppe Moscati, Avellino, Italy (A. Risitano).""}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'de Castro', 'Affiliation': ""From the Department of Haematology, St. James's University Hospital, Leeds (P.H., M.G.), and Lisa Tan Pharma Consulting, Cambridge (L.T.) - both in the United Kingdom; the Department of Clinical Haematology, Peter MacCallum Cancer Center and Royal Melbourne Hospital, Melbourne, VIC, Australia (J.S.); Jane Anne Nohl Division of Hematology, Keck School of Medicine of USC, Los Angeles (I.W.); the Department of Hematology, West German Cancer Center University Hospital Essen, University of Duisburg-Essen, Essen (A. Röth), the Institute of Transfusion Medicine, University of Ulm and Institute of Clinical Transfusion Medicine and Immunogenetics, German Red Cross Blood Transfusion Service and University Hospital Ulm, Ulm (B.H.), and the Department of Oncology, Hematology, Hemostaseology and Stem Cell Transplantation, University Hospital RWTH Aachen, Aachen (J.P.) - all in Germany; the Department of Hematology, NTT Medical Center Tokyo, Tokyo (K.U.), and the Department of Hematology and Oncology, Okayama University Hospital, Okayama (H.N.) - both in Japan; Centre d'Investigations Cliniques (J.-J.K.) and the French Reference Center for Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria (R.P.T.), Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Université de Paris, Paris; the Department of Medicine, Division of Hematologic Malignancies and Cellular Therapy, Duke University, Durham, NC (C.C.); Apellis Pharmaceuticals, Waltham, MA (M.H., P.D., C.F., F.G., T.A.); and the Hematology and BMT Unit, AORN San Giuseppe Moscati, Avellino, Italy (A. Risitano).""}, {'ForeName': 'Hisakazu', 'Initials': 'H', 'LastName': 'Nishimori', 'Affiliation': ""From the Department of Haematology, St. James's University Hospital, Leeds (P.H., M.G.), and Lisa Tan Pharma Consulting, Cambridge (L.T.) - both in the United Kingdom; the Department of Clinical Haematology, Peter MacCallum Cancer Center and Royal Melbourne Hospital, Melbourne, VIC, Australia (J.S.); Jane Anne Nohl Division of Hematology, Keck School of Medicine of USC, Los Angeles (I.W.); the Department of Hematology, West German Cancer Center University Hospital Essen, University of Duisburg-Essen, Essen (A. Röth), the Institute of Transfusion Medicine, University of Ulm and Institute of Clinical Transfusion Medicine and Immunogenetics, German Red Cross Blood Transfusion Service and University Hospital Ulm, Ulm (B.H.), and the Department of Oncology, Hematology, Hemostaseology and Stem Cell Transplantation, University Hospital RWTH Aachen, Aachen (J.P.) - all in Germany; the Department of Hematology, NTT Medical Center Tokyo, Tokyo (K.U.), and the Department of Hematology and Oncology, Okayama University Hospital, Okayama (H.N.) - both in Japan; Centre d'Investigations Cliniques (J.-J.K.) and the French Reference Center for Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria (R.P.T.), Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Université de Paris, Paris; the Department of Medicine, Division of Hematologic Malignancies and Cellular Therapy, Duke University, Durham, NC (C.C.); Apellis Pharmaceuticals, Waltham, MA (M.H., P.D., C.F., F.G., T.A.); and the Hematology and BMT Unit, AORN San Giuseppe Moscati, Avellino, Italy (A. Risitano).""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tan', 'Affiliation': ""From the Department of Haematology, St. James's University Hospital, Leeds (P.H., M.G.), and Lisa Tan Pharma Consulting, Cambridge (L.T.) - both in the United Kingdom; the Department of Clinical Haematology, Peter MacCallum Cancer Center and Royal Melbourne Hospital, Melbourne, VIC, Australia (J.S.); Jane Anne Nohl Division of Hematology, Keck School of Medicine of USC, Los Angeles (I.W.); the Department of Hematology, West German Cancer Center University Hospital Essen, University of Duisburg-Essen, Essen (A. Röth), the Institute of Transfusion Medicine, University of Ulm and Institute of Clinical Transfusion Medicine and Immunogenetics, German Red Cross Blood Transfusion Service and University Hospital Ulm, Ulm (B.H.), and the Department of Oncology, Hematology, Hemostaseology and Stem Cell Transplantation, University Hospital RWTH Aachen, Aachen (J.P.) - all in Germany; the Department of Hematology, NTT Medical Center Tokyo, Tokyo (K.U.), and the Department of Hematology and Oncology, Okayama University Hospital, Okayama (H.N.) - both in Japan; Centre d'Investigations Cliniques (J.-J.K.) and the French Reference Center for Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria (R.P.T.), Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Université de Paris, Paris; the Department of Medicine, Division of Hematologic Malignancies and Cellular Therapy, Duke University, Durham, NC (C.C.); Apellis Pharmaceuticals, Waltham, MA (M.H., P.D., C.F., F.G., T.A.); and the Hematology and BMT Unit, AORN San Giuseppe Moscati, Avellino, Italy (A. Risitano).""}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Hamdani', 'Affiliation': ""From the Department of Haematology, St. James's University Hospital, Leeds (P.H., M.G.), and Lisa Tan Pharma Consulting, Cambridge (L.T.) - both in the United Kingdom; the Department of Clinical Haematology, Peter MacCallum Cancer Center and Royal Melbourne Hospital, Melbourne, VIC, Australia (J.S.); Jane Anne Nohl Division of Hematology, Keck School of Medicine of USC, Los Angeles (I.W.); the Department of Hematology, West German Cancer Center University Hospital Essen, University of Duisburg-Essen, Essen (A. Röth), the Institute of Transfusion Medicine, University of Ulm and Institute of Clinical Transfusion Medicine and Immunogenetics, German Red Cross Blood Transfusion Service and University Hospital Ulm, Ulm (B.H.), and the Department of Oncology, Hematology, Hemostaseology and Stem Cell Transplantation, University Hospital RWTH Aachen, Aachen (J.P.) - all in Germany; the Department of Hematology, NTT Medical Center Tokyo, Tokyo (K.U.), and the Department of Hematology and Oncology, Okayama University Hospital, Okayama (H.N.) - both in Japan; Centre d'Investigations Cliniques (J.-J.K.) and the French Reference Center for Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria (R.P.T.), Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Université de Paris, Paris; the Department of Medicine, Division of Hematologic Malignancies and Cellular Therapy, Duke University, Durham, NC (C.C.); Apellis Pharmaceuticals, Waltham, MA (M.H., P.D., C.F., F.G., T.A.); and the Hematology and BMT Unit, AORN San Giuseppe Moscati, Avellino, Italy (A. Risitano).""}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Deschatelets', 'Affiliation': ""From the Department of Haematology, St. James's University Hospital, Leeds (P.H., M.G.), and Lisa Tan Pharma Consulting, Cambridge (L.T.) - both in the United Kingdom; the Department of Clinical Haematology, Peter MacCallum Cancer Center and Royal Melbourne Hospital, Melbourne, VIC, Australia (J.S.); Jane Anne Nohl Division of Hematology, Keck School of Medicine of USC, Los Angeles (I.W.); the Department of Hematology, West German Cancer Center University Hospital Essen, University of Duisburg-Essen, Essen (A. Röth), the Institute of Transfusion Medicine, University of Ulm and Institute of Clinical Transfusion Medicine and Immunogenetics, German Red Cross Blood Transfusion Service and University Hospital Ulm, Ulm (B.H.), and the Department of Oncology, Hematology, Hemostaseology and Stem Cell Transplantation, University Hospital RWTH Aachen, Aachen (J.P.) - all in Germany; the Department of Hematology, NTT Medical Center Tokyo, Tokyo (K.U.), and the Department of Hematology and Oncology, Okayama University Hospital, Okayama (H.N.) - both in Japan; Centre d'Investigations Cliniques (J.-J.K.) and the French Reference Center for Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria (R.P.T.), Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Université de Paris, Paris; the Department of Medicine, Division of Hematologic Malignancies and Cellular Therapy, Duke University, Durham, NC (C.C.); Apellis Pharmaceuticals, Waltham, MA (M.H., P.D., C.F., F.G., T.A.); and the Hematology and BMT Unit, AORN San Giuseppe Moscati, Avellino, Italy (A. Risitano).""}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Francois', 'Affiliation': ""From the Department of Haematology, St. James's University Hospital, Leeds (P.H., M.G.), and Lisa Tan Pharma Consulting, Cambridge (L.T.) - both in the United Kingdom; the Department of Clinical Haematology, Peter MacCallum Cancer Center and Royal Melbourne Hospital, Melbourne, VIC, Australia (J.S.); Jane Anne Nohl Division of Hematology, Keck School of Medicine of USC, Los Angeles (I.W.); the Department of Hematology, West German Cancer Center University Hospital Essen, University of Duisburg-Essen, Essen (A. Röth), the Institute of Transfusion Medicine, University of Ulm and Institute of Clinical Transfusion Medicine and Immunogenetics, German Red Cross Blood Transfusion Service and University Hospital Ulm, Ulm (B.H.), and the Department of Oncology, Hematology, Hemostaseology and Stem Cell Transplantation, University Hospital RWTH Aachen, Aachen (J.P.) - all in Germany; the Department of Hematology, NTT Medical Center Tokyo, Tokyo (K.U.), and the Department of Hematology and Oncology, Okayama University Hospital, Okayama (H.N.) - both in Japan; Centre d'Investigations Cliniques (J.-J.K.) and the French Reference Center for Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria (R.P.T.), Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Université de Paris, Paris; the Department of Medicine, Division of Hematologic Malignancies and Cellular Therapy, Duke University, Durham, NC (C.C.); Apellis Pharmaceuticals, Waltham, MA (M.H., P.D., C.F., F.G., T.A.); and the Hematology and BMT Unit, AORN San Giuseppe Moscati, Avellino, Italy (A. Risitano).""}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Grossi', 'Affiliation': ""From the Department of Haematology, St. James's University Hospital, Leeds (P.H., M.G.), and Lisa Tan Pharma Consulting, Cambridge (L.T.) - both in the United Kingdom; the Department of Clinical Haematology, Peter MacCallum Cancer Center and Royal Melbourne Hospital, Melbourne, VIC, Australia (J.S.); Jane Anne Nohl Division of Hematology, Keck School of Medicine of USC, Los Angeles (I.W.); the Department of Hematology, West German Cancer Center University Hospital Essen, University of Duisburg-Essen, Essen (A. Röth), the Institute of Transfusion Medicine, University of Ulm and Institute of Clinical Transfusion Medicine and Immunogenetics, German Red Cross Blood Transfusion Service and University Hospital Ulm, Ulm (B.H.), and the Department of Oncology, Hematology, Hemostaseology and Stem Cell Transplantation, University Hospital RWTH Aachen, Aachen (J.P.) - all in Germany; the Department of Hematology, NTT Medical Center Tokyo, Tokyo (K.U.), and the Department of Hematology and Oncology, Okayama University Hospital, Okayama (H.N.) - both in Japan; Centre d'Investigations Cliniques (J.-J.K.) and the French Reference Center for Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria (R.P.T.), Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Université de Paris, Paris; the Department of Medicine, Division of Hematologic Malignancies and Cellular Therapy, Duke University, Durham, NC (C.C.); Apellis Pharmaceuticals, Waltham, MA (M.H., P.D., C.F., F.G., T.A.); and the Hematology and BMT Unit, AORN San Giuseppe Moscati, Avellino, Italy (A. Risitano).""}, {'ForeName': 'Temitayo', 'Initials': 'T', 'LastName': 'Ajayi', 'Affiliation': ""From the Department of Haematology, St. James's University Hospital, Leeds (P.H., M.G.), and Lisa Tan Pharma Consulting, Cambridge (L.T.) - both in the United Kingdom; the Department of Clinical Haematology, Peter MacCallum Cancer Center and Royal Melbourne Hospital, Melbourne, VIC, Australia (J.S.); Jane Anne Nohl Division of Hematology, Keck School of Medicine of USC, Los Angeles (I.W.); the Department of Hematology, West German Cancer Center University Hospital Essen, University of Duisburg-Essen, Essen (A. Röth), the Institute of Transfusion Medicine, University of Ulm and Institute of Clinical Transfusion Medicine and Immunogenetics, German Red Cross Blood Transfusion Service and University Hospital Ulm, Ulm (B.H.), and the Department of Oncology, Hematology, Hemostaseology and Stem Cell Transplantation, University Hospital RWTH Aachen, Aachen (J.P.) - all in Germany; the Department of Hematology, NTT Medical Center Tokyo, Tokyo (K.U.), and the Department of Hematology and Oncology, Okayama University Hospital, Okayama (H.N.) - both in Japan; Centre d'Investigations Cliniques (J.-J.K.) and the French Reference Center for Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria (R.P.T.), Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Université de Paris, Paris; the Department of Medicine, Division of Hematologic Malignancies and Cellular Therapy, Duke University, Durham, NC (C.C.); Apellis Pharmaceuticals, Waltham, MA (M.H., P.D., C.F., F.G., T.A.); and the Hematology and BMT Unit, AORN San Giuseppe Moscati, Avellino, Italy (A. Risitano).""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Risitano', 'Affiliation': ""From the Department of Haematology, St. James's University Hospital, Leeds (P.H., M.G.), and Lisa Tan Pharma Consulting, Cambridge (L.T.) - both in the United Kingdom; the Department of Clinical Haematology, Peter MacCallum Cancer Center and Royal Melbourne Hospital, Melbourne, VIC, Australia (J.S.); Jane Anne Nohl Division of Hematology, Keck School of Medicine of USC, Los Angeles (I.W.); the Department of Hematology, West German Cancer Center University Hospital Essen, University of Duisburg-Essen, Essen (A. Röth), the Institute of Transfusion Medicine, University of Ulm and Institute of Clinical Transfusion Medicine and Immunogenetics, German Red Cross Blood Transfusion Service and University Hospital Ulm, Ulm (B.H.), and the Department of Oncology, Hematology, Hemostaseology and Stem Cell Transplantation, University Hospital RWTH Aachen, Aachen (J.P.) - all in Germany; the Department of Hematology, NTT Medical Center Tokyo, Tokyo (K.U.), and the Department of Hematology and Oncology, Okayama University Hospital, Okayama (H.N.) - both in Japan; Centre d'Investigations Cliniques (J.-J.K.) and the French Reference Center for Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria (R.P.T.), Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Université de Paris, Paris; the Department of Medicine, Division of Hematologic Malignancies and Cellular Therapy, Duke University, Durham, NC (C.C.); Apellis Pharmaceuticals, Waltham, MA (M.H., P.D., C.F., F.G., T.A.); and the Hematology and BMT Unit, AORN San Giuseppe Moscati, Avellino, Italy (A. Risitano).""}, {'ForeName': 'Régis Peffault', 'Initials': 'RP', 'LastName': 'de la Tour', 'Affiliation': ""From the Department of Haematology, St. James's University Hospital, Leeds (P.H., M.G.), and Lisa Tan Pharma Consulting, Cambridge (L.T.) - both in the United Kingdom; the Department of Clinical Haematology, Peter MacCallum Cancer Center and Royal Melbourne Hospital, Melbourne, VIC, Australia (J.S.); Jane Anne Nohl Division of Hematology, Keck School of Medicine of USC, Los Angeles (I.W.); the Department of Hematology, West German Cancer Center University Hospital Essen, University of Duisburg-Essen, Essen (A. Röth), the Institute of Transfusion Medicine, University of Ulm and Institute of Clinical Transfusion Medicine and Immunogenetics, German Red Cross Blood Transfusion Service and University Hospital Ulm, Ulm (B.H.), and the Department of Oncology, Hematology, Hemostaseology and Stem Cell Transplantation, University Hospital RWTH Aachen, Aachen (J.P.) - all in Germany; the Department of Hematology, NTT Medical Center Tokyo, Tokyo (K.U.), and the Department of Hematology and Oncology, Okayama University Hospital, Okayama (H.N.) - both in Japan; Centre d'Investigations Cliniques (J.-J.K.) and the French Reference Center for Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria (R.P.T.), Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Université de Paris, Paris; the Department of Medicine, Division of Hematologic Malignancies and Cellular Therapy, Duke University, Durham, NC (C.C.); Apellis Pharmaceuticals, Waltham, MA (M.H., P.D., C.F., F.G., T.A.); and the Hematology and BMT Unit, AORN San Giuseppe Moscati, Avellino, Italy (A. Risitano).""}]",The New England journal of medicine,['10.1056/NEJMoa2029073'] 2703,33793585,Polyethylene eye-cover versus artificial teardrops in the prevention of ocular surface diseases in comatose patients: A prospective multicenter randomized triple-blinded three-arm clinical trial.,"BACKGROUND Polyethylene covers are claimed to be useful in preventing ocular surface diseases (OSD); however, evidence of their clinical efficacy is limited. This clinical trial aimed to compare the use of polyethylene eye covers and artificial teardrops versus normal saline on the incidence and severity of OSD in comatose patients. METHODS Of 90 eligible patients randomly assigned to three treatment groups, 79 patients completed the study, In group A, patients (n = 25) received artificial teardrops for left and normal saline for right eyes, in group B (n = 29) polyethylene covers for left and normal saline for right eyes, and in group C (n = 25) polyethylene covers for left and artificial teardrops for right eyes. As the patients were comatose, their blinding did not applicable, and a blinded observer evaluated the patients' eyes based on the Corneal Fluorescein Staining Pattern. The blinded analyzer analyzed collected data by SPSS-16 software at a 95% confidential level. RESULTS The OSDs were observed in 65 (41.14%) out of 158 eyes examined. The artificial teardrop was more effective than the normal saline in group A, polyethylene eye cover was more useful than the normal saline in group B, and polyethylene eye cover was more effective than the artificial teardrop in group C in reducing the incidence of OSD (p< 0.01). Polyethylene eye covers had the most impact on reducing the severity of the OSD compared to the other interventions (p< .001). CONCLUSIONS Polyethylene eye covers significantly reduced the incidence and severity of OSD. Using polyethylene cover is suggested as a safe, effective, and accessible eye care intervention for preventing OSD in comatose patients. TRIAL REGISTRATION (IRCT201609129014N115), Iranian Registry of Clinical Trials.",2021,"Polyethylene eye covers had the most impact on reducing the severity of the OSD compared to the other interventions (p< .001). ","['79 patients completed the study', 'Of 90 eligible patients randomly assigned to three treatment groups', 'comatose patients']","['Polyethylene eye-cover versus artificial teardrops', 'polyethylene covers for left and normal saline for right eyes, and in group C (n = 25) polyethylene covers for left and artificial teardrops for right eyes', 'artificial teardrops for left and normal saline', 'polyethylene eye covers and artificial teardrops versus normal saline']","['incidence of OSD', 'OSDs', 'severity of the OSD', 'incidence and severity of OSD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009421', 'cui_str': 'Coma'}]","[{'cui': 'C0032487', 'cui_str': 'Polyethylenes'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0229089', 'cui_str': 'Right eye structure'}, {'cui': 'C0441837', 'cui_str': 'Group C'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",158.0,0.0492631,"Polyethylene eye covers had the most impact on reducing the severity of the OSD compared to the other interventions (p< .001). ","[{'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Khatiban', 'Affiliation': 'Department of Medical-Surgical Nursing, Department of Ethics Education in Medical Sciences, Mother & Child Care Research Center, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Moradi Amin', 'Affiliation': 'Students Research Center, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Gholamhosein', 'Initials': 'G', 'LastName': 'Falahinia', 'Affiliation': 'Department of Medical-Surgical Nursing, Chronic Disease (Home Care) Research Center, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Moghimbeigi', 'Affiliation': 'Department of Biostatistics and Epidemiology, Modeling of Noncommunicable Disease Research Canter, School of Public Health, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Yadollahi', 'Affiliation': 'Malayer Mehr Hospital, Hamadan University of Medical Sciences, Hamadan, Iran.'}]",PloS one,['10.1371/journal.pone.0248830'] 2704,33793580,Examining therapeutic equivalence between branded and generic warfarin in Brazil: The WARFA crossover randomized controlled trial.,"OBJECTIVES To determine whether the generic and branded warfarins used as anticoagulants in Brazil are therapeutic equivalents based on their international normalized ratio (INR) results. METHODS This crossover randomized controlled trial had four periods. We used the branded Marevan and two generic versions of warfarin sodium tablets, manufactured by União Química and Teuto laboratories, all purchased from retail drugstores. Eligible participants were outpatients from an anticoagulation clinic at a university hospital in São Paulo, Brazil. They had atrial fibrillation or flutter and had been using warfarin for at least 2 months with an INR therapeutic range of 2.0-3.0. Randomization was by numbered, opaque, sealed envelopes. Healthcare personnel and outcome assessors were blinded to treatments, but patients were not. The primary outcome was the variability in the INR (ΔINR) and secondary outcomes included mean INR. We accepted formulations as equivalent if the 95% confidence interval (CI) of the comparison of ΔINR between branded and generic formulations was within the limit of ±0.49. RESULTS One hundred patients were recruited and randomized to six sequences of treatment (four sequences with n = 17 and two sequences with n = 16). União Química generic warfarin had equivalent variability in the INR to Marevan (ΔINR +0.09 [95% CI -0.29 to +0.46], n = 84). Comparison between Teuto generic warfarin and Marevan was inconclusive (ΔINR +0.29 [95% CI -0.09 to +0.68], n = 84). CONCLUSIONS Marevan and União Química warfarin had equivalent therapeutic effectiveness and both could be confidently used for anticoagulation. The comparison between Marevan and TW was inconclusive and does not warrant a statement of equivalence. Our methods are especially important for comparing generic and branded drugs that raise concerns and may be subject of future investigations by regulatory agents. TRIAL REGISTRATION ClinicalTrials.gov NCT02017197.",2021,"CONCLUSIONS Marevan and União Química warfarin had equivalent therapeutic effectiveness and both could be confidently used for anticoagulation.","['One hundred patients', 'Eligible participants were outpatients from an anticoagulation clinic at a university hospital in São Paulo, Brazil', 'Brazil']","['warfarin sodium tablets, manufactured by União Química and Teuto laboratories, all purchased from retail drugstores', 'warfarin', 'branded and generic warfarin']","['variability in the INR (ΔINR) and secondary outcomes included mean INR', 'atrial fibrillation or flutter']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C3839946', 'cui_str': 'Anticoagulation clinic'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0376218', 'cui_str': 'Warfarin sodium'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}]","[{'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]",100.0,0.256986,"CONCLUSIONS Marevan and União Química warfarin had equivalent therapeutic effectiveness and both could be confidently used for anticoagulation.","[{'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Gomes Freitas', 'Affiliation': 'Department of Medicine, Escola Paulista de Medicina, Universidade Federal de São Paulo (UNIFESP), São Paulo, SP, Brazil.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Walsh', 'Affiliation': 'Departments of Medicine (Nephrology) and Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Enia Lucia', 'Initials': 'EL', 'LastName': 'Coutinho', 'Affiliation': 'Clinical Cardiac Electrophysiology, Cardiology Division, Department of Medicine, Federal University of Sao Paulo, Escola Paulista de Medicina, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Angelo Amato', 'Initials': 'AA', 'LastName': 'Vincenzo de Paola', 'Affiliation': 'Clinical Cardiac Electrophysiology, Cardiology Division, Department of Medicine, Federal University of Sao Paulo, Escola Paulista de Medicina, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Álvaro Nagib', 'Initials': 'ÁN', 'LastName': 'Atallah', 'Affiliation': 'Discipline of Emergency Medicine and Evidence-Based Medicine, Escola Paulista de Medicina, Universidade Federal de Sao Paulo (UNIFESP), São Paulo, SP, Brazil.'}]",PloS one,['10.1371/journal.pone.0248567'] 2705,33785743,Peginterferon Lambda-1a for treatment of outpatients with uncomplicated COVID-19: a randomized placebo-controlled trial.,"Type III interferons have been touted as promising therapeutics in outpatients with coronavirus disease 2019 (COVID-19). We conducted a randomized, single-blind, placebo-controlled trial (NCT04331899) in 120 outpatients with mild to moderate COVID-19 to determine whether a single, 180 mcg subcutaneous dose of Peginterferon Lambda-1a (Lambda) within 72 hours of diagnosis could shorten the duration of viral shedding (primary endpoint) or symptoms (secondary endpoint). In both the 60 patients receiving Lambda and 60 receiving placebo, the median time to cessation of viral shedding was 7 days (hazard ratio [HR] = 0.81; 95% confidence interval [CI] 0.56 to 1.19). Symptoms resolved in 8 and 9 days in Lambda and placebo, respectively, and symptom duration did not differ significantly between groups (HR 0.94; 95% CI 0.64 to 1.39). Both Lambda and placebo were well-tolerated, though liver transaminase elevations were more common in the Lambda vs. placebo arm (15/60 vs 5/60; p = 0.027). In this study, a single dose of subcutaneous Peginterferon Lambda-1a neither shortened the duration of SARS-CoV-2 viral shedding nor improved symptoms in outpatients with uncomplicated COVID-19.",2021,"Symptoms resolved in 8 and 9 days in Lambda and placebo, respectively, and symptom duration did not differ significantly between groups (HR 0.94; 95% CI 0.64 to 1.39).","['60 patients receiving Lambda and 60 receiving', '120 outpatients with mild to moderate COVID-19 to determine whether a single, 180 mcg subcutaneous dose of Peginterferon Lambda-1a (Lambda) within 72 hours of diagnosis could shorten the duration of viral shedding (primary endpoint) or symptoms (secondary endpoint', 'outpatients with uncomplicated COVID-19', 'outpatients with coronavirus disease 2019 (COVID-19']","['placebo', 'Peginterferon Lambda-1a', 'subcutaneous Peginterferon Lambda-1a']","['symptom duration', 'median time to cessation of viral shedding', 'tolerated', 'liver transaminase elevations', 'duration of SARS-CoV-2 viral shedding nor improved symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1720314', 'cui_str': 'Lambda'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4043002', 'cui_str': 'peginterferon lambda-1a'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0162633', 'cui_str': 'Viral Shedding'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4043002', 'cui_str': 'peginterferon lambda-1a'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0162633', 'cui_str': 'Viral Shedding'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",120.0,0.505733,"Symptoms resolved in 8 and 9 days in Lambda and placebo, respectively, and symptom duration did not differ significantly between groups (HR 0.94; 95% CI 0.64 to 1.39).","[{'ForeName': 'Prasanna', 'Initials': 'P', 'LastName': 'Jagannathan', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA. prasj@stanford.edu.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Andrews', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Bonilla', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Hedlin', 'Affiliation': 'Quantitative Sciences Unit, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Karen B', 'Initials': 'KB', 'LastName': 'Jacobson', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Vidhya', 'Initials': 'V', 'LastName': 'Balasubramanian', 'Affiliation': 'Quantitative Sciences Unit, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Purington', 'Affiliation': 'Quantitative Sciences Unit, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Savita', 'Initials': 'S', 'LastName': 'Kamble', 'Affiliation': 'Stanford Center for Clinical Research, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Christiaan R', 'Initials': 'CR', 'LastName': 'de Vries', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Orlando', 'Initials': 'O', 'LastName': 'Quintero', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Feng', 'Affiliation': 'Stanford Center for Clinical Research, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ley', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Winslow', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Newberry', 'Affiliation': 'Department of Emergency Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Karlie', 'Initials': 'K', 'LastName': 'Edwards', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Hislop', 'Affiliation': 'Department of Pediatrics, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Choong', 'Affiliation': 'Department of Pediatrics, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Maldonado', 'Affiliation': 'Eiger BioPharmaceuticals, Palo Alto, CA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Glenn', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Ami', 'Initials': 'A', 'LastName': 'Bhatt', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Blish', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Taia', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Chaitan', 'Initials': 'C', 'LastName': 'Khosla', 'Affiliation': 'ChEM-H, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Pinsky', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Desai', 'Affiliation': 'Quantitative Sciences Unit, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Parsonnet', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Upinder', 'Initials': 'U', 'LastName': 'Singh', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA. usingh@stanford.edu.'}]",Nature communications,['10.1038/s41467-021-22177-1'] 2706,33799037,Associations between baseline cortisol and trajectory of symptom improvement in depressed adolescents receiving psychological therapy.,"BACKGROUND Cortisol hypersecretion in depressed adolescents and adults is associated with more persistent illness and may signal a lower response to psychological therapies. A meta-analysis of small and heterogenous studies demonstrated that higher pre-treatment basal cortisol levels were associated with poorer response specifically to psychological therapy for depression. The objective of this study was to investigate the relationship between both morning and evening salivary cortisol levels and response to psychological therapy in depressed adolescents participating in one large randomised controlled trial. METHODS We tested the association between morning and evening salivary cortisol levels at baseline and improvement in depressive symptoms in response to psychological therapies in depressed adolescents at 6 time points: baseline, 6, 12, 36, 52- and 86-weeks post-randomisation, using the self-reported Mood and Feelings Questionnaire (MFQ). RESULTS High evening cortisol was associated with a slower initial decline in depressive symptoms (cortisol x quadratic time p = .022); however it was not associated with total change in depressive symtoms over the whole course of the study. Morning cortisol was not associated with change in depressive symptoms. These effects were not significantly different across the three psychological therapies. LIMITATIONS Results may not generalize to adolescents receiving other treatments (medication) or no treatment, and may not generalize to adults. Only a minority of eligible participants collected valid cortisol samples. CONCLUSIONS Higher pretreatment evening cortisol may impair a depressed adolescent's ability to use psychological therapy.",2021,"RESULTS High evening cortisol was associated with a slower initial decline in depressive symptoms (cortisol x quadratic time","['depressed adolescents participating in one large randomised controlled trial', 'depressed adolescents at 6 time points: baseline, 6, 12, 36, 52- and 86-weeks post-randomisation, using the self-reported Mood and Feelings Questionnaire (MFQ', 'depressed adolescents and adults', 'depressed adolescents receiving psychological therapy']",['psychological therapy'],"['total change in depressive symtoms', 'depressive symptoms (cortisol x quadratic time', 'depressive symptoms']","[{'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0841584', 'cui_str': 'Psychological therapies'}]","[{'cui': 'C0841584', 'cui_str': 'Psychological therapies'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.130034,"RESULTS High evening cortisol was associated with a slower initial decline in depressive symptoms (cortisol x quadratic time","[{'ForeName': 'Ankit', 'Initials': 'A', 'LastName': 'Chadha', 'Affiliation': 'University of Cambridge.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Neufeld', 'Affiliation': 'University of Cambridge.'}, {'ForeName': 'Ian Michael', 'Initials': 'IM', 'LastName': 'Goodyer', 'Affiliation': 'University of Cambridge, Cambridgeshire and Peterborough NHS Foundation Trust.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fonagy', 'Affiliation': 'University College London, Anna Freud Centre.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Midgley', 'Affiliation': 'University College London, Anna Freud Centre.'}, {'ForeName': 'Paul Oliver', 'Initials': 'PO', 'LastName': 'Wilkinson', 'Affiliation': 'University of Cambridge, Cambridgeshire and Peterborough NHS Foundation Trust. Electronic address: pow12@cam.ac.uk.'}]",Journal of affective disorders,['10.1016/j.jad.2021.03.046'] 2707,33798921,Contingency management for smoking cessation among individuals with substance use disorders: In-treatment and post-treatment effects.,"INTRODUCTION Smokers with substance use disorders (SUDs) show elevated tobacco prevalence, and smoking abstinence rates are considerably low. This randomized controlled trial sought to compare the effect of a cognitive behavioral treatment (CBT) that includes an episodic future thinking (EFT) component with the same treatment protocol plus contingency management (CM). This study aims to examine the effect of CM on smoking outcomes and in-treatment behaviors (i.e., retention, session attendance and adherence to nicotine use reduction guidelines), and to analyze whether these in-treatment variables predicted days of continuous abstinence at end-of-treatment. METHOD A total of 54 treatment-seeking participants (75.9% males, M = 46.19 years old) were allocated to CBT + EFT (n = 30) or CBT + EFT + CM (n = 24). Intervention consisted of eight weeks of group-based sessions. Tobacco abstinence was verified biochemically by testing levels of carbon monoxide (≤4ppm) and urine cotinine (≤80 ng/ml). RESULTS CM intervention increased 24-hour tobacco abstinence (50% vs. 20%, χ 2 (1) = 5.4; p = .021) and days of continuous abstinence (M = 5.92 ± 7.67 vs. 5.53 ± 12.42; t(52) = -0.132; p = 0.89) at end-of-treatment in comparison with CBT + EFT intervention. Although not statistically significant, CBT + EFT + CM enhanced in-treatment behaviors, in terms of retention (83.3% vs. 70%; χ 2 (1) = 0.255; p = .208), sessions attended (12.29 ± 3.22 vs. 10.93 ± 3.26; t(52) = -1.527; p = .133) and adherence to weekly nicotine use reduction targets (41.07% ± 31.96 vs. 35% ±2 6.28; t(52) = -0.766; p = .447). A higher percentage of samples meeting reduction guidelines (β = 0.609; p<.001) predicted days of continuous abstinence at end-of-treatment. CONCLUSION Combining CM with CBT + EFT improves short-term quitting rates. Findings suggest the need to incorporate strategies for improving adherence to nicotine reduction guidelines.",2021,"RESULTS CM intervention increased 24-hour tobacco abstinence (50% vs. 20%, χ 2 (1) = 5.4; p = .021) and days of continuous abstinence (M = 5.92 ± 7.67 vs. 5.53 ± 12.42; t(52) = -0.132; p = 0.89) at end-of-treatment in comparison with CBT + EFT intervention.","['46.19\xa0years old', 'A total of 54 treatment-seeking participants (75.9% males, M\xa0', 'individuals with substance use disorders', 't(52)\xa0']","['Contingency management', 'CM', 'CBT\xa0+\xa0EFT', 'CBT\xa0+\xa0EFT\xa0+\xa0CM', 'cognitive behavioral treatment (CBT']","['carbon monoxide (≤4ppm) and urine cotinine', '24-hour tobacco abstinence', 'Tobacco abstinence', 'short-term quitting rates', 'tobacco prevalence, and smoking abstinence rates']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}]","[{'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0016884', 'cui_str': 'Future'}]","[{'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C1697737', 'cui_str': 'Urine cotinine test'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}]",,0.0389346,"RESULTS CM intervention increased 24-hour tobacco abstinence (50% vs. 20%, χ 2 (1) = 5.4; p = .021) and days of continuous abstinence (M = 5.92 ± 7.67 vs. 5.53 ± 12.42; t(52) = -0.132; p = 0.89) at end-of-treatment in comparison with CBT + EFT intervention.","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Aonso-Diego', 'Affiliation': 'Department of Psychology, University of Oviedo, Plaza Feijoo s/n, 33003 Oviedo, Spain. Electronic address: aonsogema@uniovi.es.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'González-Roz', 'Affiliation': 'Department of Psychology, University of Oviedo, Plaza Feijoo s/n, 33003 Oviedo, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Krotter', 'Affiliation': 'Department of Psychology, University of Oviedo, Plaza Feijoo s/n, 33003 Oviedo, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'García-Pérez', 'Affiliation': 'Department of Psychology, University of Oviedo, Plaza Feijoo s/n, 33003 Oviedo, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Secades-Villa', 'Affiliation': 'Department of Psychology, University of Oviedo, Plaza Feijoo s/n, 33003 Oviedo, Spain.'}]",Addictive behaviors,['10.1016/j.addbeh.2021.106920'] 2708,33798801,Young women's body image following upwards comparison to Instagram models: The role of physical appearance perfectionism and cognitive emotion regulation.,"The present study examined whether trait physical appearance perfectionism moderates young women's body image following upwards appearance comparison to idealized body images on social media, and whether cognitive coping mediates the relationship between physical appearance perfectionism and resulting body image from social comparison processes. Female undergraduate students (N = 142) were randomly assigned to either 1) compare the size of their body parts to the body parts of attractive Instagram models, or 2) an appearance-neutral control condition. All participants completed measures of trait physical appearance perfectionism, pre and post measures of state body image, and state cognitive coping processes. Appearance comparison to the models resulted in lowered confidence and increased appearance and weight dissatisfaction. High trait physical appearance perfectionism predicted lower confidence and higher weight dissatisfaction and appearance dissatisfaction, and these relationships were mediated by engagement in rumination and catastrophizing. Clinical implications of the findings are discussed.",2021,"High trait physical appearance perfectionism predicted lower confidence and higher weight dissatisfaction and appearance dissatisfaction, and these relationships were mediated by engagement in rumination and catastrophizing.",['Female undergraduate students (N = 142'],"['physical appearance perfectionism and cognitive emotion regulation', 'size of their body parts to the body parts of attractive Instagram models, or 2) an appearance-neutral control condition']","['appearance and weight dissatisfaction', 'trait physical appearance perfectionism, pre and post measures of state body image, and state cognitive coping processes']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0750731', 'cui_str': 'Body, Physical Appearance'}, {'cui': 'C0815110', 'cui_str': 'Perfectionism'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0229962', 'cui_str': 'Body part structure'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0750731', 'cui_str': 'Body, Physical Appearance'}, {'cui': 'C0815110', 'cui_str': 'Perfectionism'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C1522240', 'cui_str': 'Process'}]",142.0,0.00653255,"High trait physical appearance perfectionism predicted lower confidence and higher weight dissatisfaction and appearance dissatisfaction, and these relationships were mediated by engagement in rumination and catastrophizing.","[{'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'McComb', 'Affiliation': 'Department of Psychology, York University, 4700 Keele St, Toronto, ON, M3J 1P3, Canada. Electronic address: mccombs@yorku.ca.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Mills', 'Affiliation': 'Department of Psychology, York University, 4700 Keele St, Toronto, ON, M3J 1P3, Canada. Electronic address: jsmills@yorku.ca.'}]",Body image,['10.1016/j.bodyim.2021.03.012'] 2709,33798696,Perirhinal damage produces modality-dependent deficits in fear learning.,"The perirhinal cortex (PER) receives multimodal and unimodal sensory information from all modalities. In addition, the PER is anatomically connected with several brain regions that support fear learning. Several studies suggest that the PER is involved in fear conditioning to discontinuous auditory cues but not to continuous auditory cues. To date, studies examining the role of the PER in fear conditioning has largely focused on auditory and contextual stimuli. The present study assessed whether the role of the PER in fear conditioning would extend to visual modalities. Rodents were randomly assigned to one of four conditioned stimuli, which consisted of either a tone or a light stimulus that was either continuous or discontinuous. Pre-training excitotoxic lesions to the PER significantly reduced freezing to auditory and visual cues during the acquisition phase regardless of stimulus continuity. During subsequent testing, perirhinal lesions produced significant decreases in freezing levels to both continuous and discontinuous tones but not to either of the light CS groups. These results suggest that the PER is involved in the acquisition of fear across multiple cue modalities. However, the PER may have a more limited role in the retrieval of the fear memory dependent upon the cue modality.",2021,"During subsequent testing, perirhinal lesions produced significant decreases in freezing levels to both continuous and discontinuous tones but not to either of the light CS groups.",['Fear Learning'],[],"['freezing levels', 'freezing to auditory and visual cues']","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",[],"[{'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]",,0.0157299,"During subsequent testing, perirhinal lesions produced significant decreases in freezing levels to both continuous and discontinuous tones but not to either of the light CS groups.","[{'ForeName': 'Trevor D', 'Initials': 'TD', 'LastName': 'Bartley', 'Affiliation': 'Department of Psychology, California State University Sacramento, Sacramento, CA 95819, USA.'}, {'ForeName': 'Sharon C', 'Initials': 'SC', 'LastName': 'Furtak', 'Affiliation': 'Department of Psychology, California State University Sacramento, Sacramento, CA 95819, USA. Electronic address: furtak@csus.edu.'}]",Neurobiology of learning and memory,['10.1016/j.nlm.2021.107427'] 2710,33798613,"Neoadjuvant hypofractionated radiotherapy and chemotherapy for extremity soft tissue sarcomas: Safety, feasibility, and early oncologic outcomes of a phase 2 trial.","BACKGROUND AND PURPOSE Optimal treatment of extremity soft tissue sarcomas (ESTS) is controversial. The aim of this study was to evaluate neoadjuvant chemotherapy (ChT) plus concomitant hypofractionated RT (hypo-RT) in local and distant disease relapse. Here we report safety, feasibility and early outcomes. MATERIALS AND METHODS This was a prospective, single arm study with a goal accrual of 70 patients. Between 2015 and 2018, 18 patients with histologically confirmed nonmetastatic ESTS were assigned to receive doxorubicin and ifosfamide for three neoadjuvant cycles, concomitant with hypo-RT (25 Gy in 5 fractions) followed by surgery. The primary endpoint was disease-free survival (DFS). Secondary outcomes were pathologic response, wound complications (WC), and morbidity rates. RESULTS Median follow-up was 29 months. At last follow-up, 13/18 patients were alive without evidence of local or systemic disease (DFS 72%), 1 had died due to metastatic disease, and 3 were alive with distant metastasis. One patient presented with local relapse within the irradiated field. Mean DFS time was 48.6 months (95% CI: 37.3-59.9). Six patients (33%) had no residual viable tumor detected in pathologic specimens (3 of these myxoid liposarcomas). There was a significant difference in WC among patients with acute RT skin toxicity. Six patients (33%) developed major WC. No grade 3 or 4 ChT adverse events were reported. CONCLUSION Despite the limited sample size, these early outcomes demonstrate that this treatment regimen is feasible and well tolerated with high rates of limb preservation, local control, and pathologic complete response, supporting further investigation in a multi-institutional setting. TRIAL REGISTRATION ClinicalTrials.gov NCT02812654; https://clinicaltrials.gov/ct2/show/NCT02812654.",2021,", these early outcomes demonstrate that this treatment regimen is feasible and well tolerated with high rates of limb preservation, local control, and pathologic complete response, supporting further investigation in a multi-institutional setting. ","['patients with acute RT skin toxicity', 'Extremity Soft Tissue Sarcomas', 'extremity soft tissue sarcomas (ESTS', '70 patients', 'Between 2015 and 2018, 18 patients with histologically confirmed nonmetastatic ESTS']","['concomitant with hypo-RT (25Gy in 5 fractions) followed by surgery', 'neoadjuvant chemotherapy plus concomitant hypofractionated RT (hypo-RT', 'Neoadjuvant Hypofractionated Radiotherapy and Chemotherapy', 'doxorubicin and ifosfamide']","['pathologic response, wound complications (WC), and morbidity rates', 'WC', 'disease-free survival (DFS', 'alive without evidence of local or systemic disease', 'local relapse', 'Mean DFS time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0020823', 'cui_str': 'Ifosfamide'}]","[{'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0442893', 'cui_str': 'Systemic disease'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",18.0,0.168417,", these early outcomes demonstrate that this treatment regimen is feasible and well tolerated with high rates of limb preservation, local control, and pathologic complete response, supporting further investigation in a multi-institutional setting. ","[{'ForeName': 'Maria Leticia', 'Initials': 'ML', 'LastName': 'Gobo Silva', 'Affiliation': 'Department of Radiation Oncology, A C Camargo Cancer Center, São Paulo, Brazil. Electronic address: leticia.silva@accamargo.org.br.'}, {'ForeName': 'Celso Abdon', 'Initials': 'CA', 'LastName': 'Lopes de Mello', 'Affiliation': 'Department of Clinical Oncology, A C Camargo Cancer Center, São Paulo, Brazil. Electronic address: celso.mello@accamargo.org.br.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Aguiar Junior', 'Affiliation': 'Division of Surgery, Department of Sarcoma, A C Camargo Cancer Center, São Paulo, Brazil. Electronic address: samuel.aguiar@accamargo.org.br.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': ""D'Almeida Costa"", 'Affiliation': 'Department of Anatomic Pathology, A C Camargo Cancer Center, São Paulo, Brazil. Electronic address: felipe.costa@accamargo.org.br.'}, {'ForeName': 'Paulo Roberto', 'Initials': 'PR', 'LastName': 'Stevanato Filho', 'Affiliation': 'Division of Surgery, Department of Sarcoma, A C Camargo Cancer Center, São Paulo, Brazil. Electronic address: paulo.stevanato@accamargo.org.br.'}, {'ForeName': 'Tiago', 'Initials': 'T', 'LastName': 'Santoro Bezerra', 'Affiliation': 'Division of Surgery, Department of Sarcoma, A C Camargo Cancer Center, São Paulo, Brazil. Electronic address: tiago.bezerra@accamargo.org.br.'}, {'ForeName': 'Suely Akiko', 'Initials': 'SA', 'LastName': 'Nakagawa', 'Affiliation': 'Division of Surgery, Department of Orthopedics, A C Camargo Cancer Center, São Paulo, Brazil. Electronic address: suely.nakagawa@accamargo.org.br.'}, {'ForeName': 'Antonio Geraldo', 'Initials': 'AG', 'LastName': 'Nascimento', 'Affiliation': 'Department of Anatomic Pathology, A C Camargo Cancer Center, São Paulo, Brazil. Electronic address: nascimento.antonio@accamargo.org.br.'}, {'ForeName': 'Isabela', 'Initials': 'I', 'LastName': 'Werneck da Cunha', 'Affiliation': 'Department of Anatomic Pathology, A C Camargo Cancer Center, São Paulo, Brazil. Electronic address: isabela.werneck@rededor.com.br.'}, {'ForeName': 'Ranyell Matheus', 'Initials': 'RM', 'LastName': 'Spencer Sobreira Batista', 'Affiliation': 'Division of Surgery, Department of Sarcoma, A C Camargo Cancer Center, São Paulo, Brazil. Electronic address: ranyell.spencer@gmail.com.'}, {'ForeName': 'Ulisses Ribaldo', 'Initials': 'UR', 'LastName': 'Nicolau Daher', 'Affiliation': 'Department of Clinical Oncology, A C Camargo Cancer Center, São Paulo, Brazil. Electronic address: ulisses.nicolau@accamargo.org.br.'}, {'ForeName': 'Maria Nirvana', 'Initials': 'MN', 'LastName': 'Da Cruz Formiga', 'Affiliation': 'Department of Clinical Oncology, A C Camargo Cancer Center, São Paulo, Brazil. Electronic address: nirvana.formiga@accamargo.org.br.'}, {'ForeName': 'Janaina Naiara', 'Initials': 'JN', 'LastName': 'Germano', 'Affiliation': 'Department of Statistics, A C Camargo Cancer Center, São Paulo, Brazil. Electronic address: janaina.germano@accamargo.org.br.'}, {'ForeName': 'Bruna Elisa', 'Initials': 'BE', 'LastName': 'Catin Kupper', 'Affiliation': 'Division of Surgery, Department of Sarcoma, A C Camargo Cancer Center, São Paulo, Brazil. Electronic address: bruna.catin@accamargo.org.br.'}, {'ForeName': 'Antonio Cassio', 'Initials': 'AC', 'LastName': 'De Assis Pellizzon', 'Affiliation': 'Department of Radiation Oncology, A C Camargo Cancer Center, São Paulo, Brazil. Electronic address: acapellizzon@accamargo.org.br.'}, {'ForeName': 'Ademar', 'Initials': 'A', 'LastName': 'Lopes', 'Affiliation': 'Division of Surgery, Department of Sarcoma, A C Camargo Cancer Center, São Paulo, Brazil. Electronic address: ademar.lopes@accamargo.org.br.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2021.03.033'] 2711,33798499,Efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 variant of concern 202012/01 (B.1.1.7): an exploratory analysis of a randomised controlled trial.,"BACKGROUND A new variant of SARS-CoV-2, B.1.1.7, emerged as the dominant cause of COVID-19 disease in the UK from November, 2020. We report a post-hoc analysis of the efficacy of the adenoviral vector vaccine, ChAdOx1 nCoV-19 (AZD1222), against this variant. METHODS Volunteers (aged ≥18 years) who were enrolled in phase 2/3 vaccine efficacy studies in the UK, and who were randomly assigned (1:1) to receive ChAdOx1 nCoV-19 or a meningococcal conjugate control (MenACWY) vaccine, provided upper airway swabs on a weekly basis and also if they developed symptoms of COVID-19 disease (a cough, a fever of 37·8°C or higher, shortness of breath, anosmia, or ageusia). Swabs were tested by nucleic acid amplification test (NAAT) for SARS-CoV-2 and positive samples were sequenced through the COVID-19 Genomics UK consortium. Neutralising antibody responses were measured using a live-virus microneutralisation assay against the B.1.1.7 lineage and a canonical non-B.1.1.7 lineage (Victoria). The efficacy analysis included symptomatic COVID-19 in seronegative participants with a NAAT positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to vaccine received. Vaccine efficacy was calculated as 1 - relative risk (ChAdOx1 nCoV-19 vs MenACWY groups) derived from a robust Poisson regression model. This study is continuing and is registered with ClinicalTrials.gov, NCT04400838, and ISRCTN, 15281137. FINDINGS Participants in efficacy cohorts were recruited between May 31 and Nov 13, 2020, and received booster doses between Aug 3 and Dec 30, 2020. Of 8534 participants in the primary efficacy cohort, 6636 (78%) were aged 18-55 years and 5065 (59%) were female. Between Oct 1, 2020, and Jan 14, 2021, 520 participants developed SARS-CoV-2 infection. 1466 NAAT positive nose and throat swabs were collected from these participants during the trial. Of these, 401 swabs from 311 participants were successfully sequenced. Laboratory virus neutralisation activity by vaccine-induced antibodies was lower against the B.1.1.7 variant than against the Victoria lineage (geometric mean ratio 8·9, 95% CI 7·2-11·0). Clinical vaccine efficacy against symptomatic NAAT positive infection was 70·4% (95% CI 43·6-84·5) for B.1.1.7 and 81·5% (67·9-89·4) for non-B.1.1.7 lineages. INTERPRETATION ChAdOx1 nCoV-19 showed reduced neutralisation activity against the B.1.1.7 variant compared with a non-B.1.1.7 variant in vitro, but the vaccine showed efficacy against the B.1.1.7 variant of SARS-CoV-2. FUNDING UK Research and Innovation, National Institute for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midlands NIHR Clinical Research Network, and AstraZeneca.",2021,Neutralising antibody responses were measured using a live-virus microneutralisation assay against the B.1.1.7 lineage and a canonical non-B.1.1.7 lineage (Victoria).,"['seronegative participants with a NAAT positive swab more than 14 days after a second dose of', '401 swabs from 311 participants were successfully sequenced', '8534 participants in the primary efficacy cohort, 6636 (78%) were aged 18-55 years and 5065 (59%) were female', 'Volunteers (aged ≥18 years) who were enrolled in phase 2/3 vaccine efficacy studies in the UK, and who were randomly assigned (1:1) to receive', 'Participants in efficacy cohorts were recruited between May 31 and Nov 13, 2020, and received booster doses between Aug 3 and Dec 30, 2020']","['ChAdOx1 nCoV-19 (AZD1222) vaccine', 'adenoviral vector vaccine, ChAdOx1 nCoV-19 (AZD1222', 'vaccine', 'ChAdOx1 nCoV-19 or a meningococcal conjugate control (MenACWY) vaccine, provided upper airway swabs']","['neutralisation activity', 'Vaccine efficacy', 'Neutralising antibody responses', 'Clinical vaccine efficacy against symptomatic NAAT positive infection', 'SARS-CoV-2 infection']","[{'cui': 'C0521144', 'cui_str': 'Seronegative'}, {'cui': 'C0200932', 'cui_str': 'Nucleic acid amplification'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0183753', 'cui_str': 'Swab'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0001483', 'cui_str': 'Adenoviridae'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0127526', 'cui_str': 'Meningococcal polysaccharide vaccine'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0225377', 'cui_str': 'Structure of upper respiratory tract cavity'}, {'cui': 'C0183753', 'cui_str': 'Swab'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0200932', 'cui_str': 'Nucleic acid amplification'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",311.0,0.536314,Neutralising antibody responses were measured using a live-virus microneutralisation assay against the B.1.1.7 lineage and a canonical non-B.1.1.7 lineage (Victoria).,"[{'ForeName': 'Katherine R W', 'Initials': 'KRW', 'LastName': 'Emary', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Golubchik', 'Affiliation': 'Big Data Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Parvinder K', 'Initials': 'PK', 'LastName': 'Aley', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Cristina V', 'Initials': 'CV', 'LastName': 'Ariani', 'Affiliation': 'Wellcome Sanger Institute, Wellcome Genome Campus, Hinxton, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Angus', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sagida', 'Initials': 'S', 'LastName': 'Bibi', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Blane', 'Affiliation': 'COVID-19 Genomics UK, Department of Medicine, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bonsall', 'Affiliation': 'Wellcome Centre for Human Genetics, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Cicconi', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Charlton', 'Affiliation': 'National Infection Service, Public Health England, Salisbury, UK.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Clutterbuck', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Collins', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine and Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Cox', 'Affiliation': 'UK Biocentre, Milton Keynes, UK.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Darton', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, UK; Department of Infection and Tropical Medicine, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Dold', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alexander D', 'Initials': 'AD', 'LastName': 'Douglas', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Christopher J A', 'Initials': 'CJA', 'LastName': 'Duncan', 'Affiliation': 'Department of Infection and Tropical Medicine, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK; Translational and Clinical Research Institute, Immunity and Inflammation Theme, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Katie J', 'Initials': 'KJ', 'LastName': 'Ewer', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Flaxman', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Saul N', 'Initials': 'SN', 'LastName': 'Faust', 'Affiliation': 'NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust; Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Daniela M', 'Initials': 'DM', 'LastName': 'Ferreira', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine and Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Finn', 'Affiliation': 'University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Pedro M', 'Initials': 'PM', 'LastName': 'Folegatti', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Fuskova', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Galiza', 'Affiliation': ""St George's Vaccine Institute, St George's, University of London, London, UK.""}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Goodman', 'Affiliation': ""Department of Infection, Guy's and St Thomas' NHS Foundation Trust, St Thomas' Hospital, London, UK; MRC Clinical Trials Unit, University College London, London, UK.""}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Green', 'Affiliation': 'Clinical BioManufacturing Facility, University of Oxford, Oxford, UK.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Green', 'Affiliation': 'NIHR/Wellcome Trust Clinical Research Facility, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Greenland', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Bassam', 'Initials': 'B', 'LastName': 'Hallis', 'Affiliation': 'National Infection Service, Public Health England, Salisbury, UK.'}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Heath', 'Affiliation': ""St George's Vaccine Institute, St George's, University of London, London, UK.""}, {'ForeName': 'Jodie', 'Initials': 'J', 'LastName': 'Hay', 'Affiliation': 'University of Glasgow, Glasgow, UK; Lighthouse Laboratory in Glasgow, Queen Elizabeth University Hospital, Glasgow, UK.'}, {'ForeName': 'Helen C', 'Initials': 'HC', 'LastName': 'Hill', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine and Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Jenkin', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kerridge', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rajeka', 'Initials': 'R', 'LastName': 'Lazarus', 'Affiliation': 'Severn Pathology, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Libri', 'Affiliation': 'NIHR UCLH Clinical Research Facility, London, UK; NIHR UCLH Biomedical Research Centre, London, UK.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Lillie', 'Affiliation': 'Hull University Teaching Hospitals NHS Trust, Hull, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ludden', 'Affiliation': 'COVID-19 Genomics UK, Department of Medicine, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Natalie G', 'Initials': 'NG', 'LastName': 'Marchevsky', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Minassian', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alastair C', 'Initials': 'AC', 'LastName': 'McGregor', 'Affiliation': 'London Northwest University Healthcare, Harrow, UK.'}, {'ForeName': 'Yama F', 'Initials': 'YF', 'LastName': 'Mujadidi', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Phillips', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Plested', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Katrina M', 'Initials': 'KM', 'LastName': 'Pollock', 'Affiliation': 'NIHR Imperial Clinical Research Facility, London, UK; NIHR Imperial Biomedical Research Centre, London, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Robinson', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'College of Medical, Veterinary & Life Sciences, Glasgow Dental Hospital and School, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Rinn', 'Initials': 'R', 'LastName': 'Song', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Snape', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Sutherland', 'Affiliation': 'Clinical Infection Research Group, Regional Infectious Diseases Unit, Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'Emma C', 'Initials': 'EC', 'LastName': 'Thomson', 'Affiliation': 'MRC University of Glasgow Centre for Virus Research, Glasgow, UK; Severn Pathology, North Bristol NHS Trust, Bristol, UK; Department of Infectious Diseases, Queen Elizabeth University Hospital, Glasgow, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Toshner', 'Affiliation': 'Heart Lung Research Institute, Department of Medicine, University of Cambridge, Cambridge, UK; NIHR Cambridge Clinical Research Facility, Cambridge, UK; Cambridge University Hospital and Royal Papworth NHS Foundation Trusts, Cambridge, UK.'}, {'ForeName': 'David P J', 'Initials': 'DPJ', 'LastName': 'Turner', 'Affiliation': 'University of Nottingham, Nottingham, UK; Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Vekemans', 'Affiliation': 'AstraZeneca BioPharmaceuticals, Gaithersburg, MD, USA.'}, {'ForeName': 'Tonya L', 'Initials': 'TL', 'LastName': 'Villafana', 'Affiliation': 'AstraZeneca BioPharmaceuticals, Gaithersburg, MD, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Williams', 'Affiliation': 'Public Health Wales, Cardiff, UK; Aneurin Bevan University Health Board, Newport, UK.'}, {'ForeName': 'Adrian V S', 'Initials': 'AVS', 'LastName': 'Hill', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Lambe', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Gilbert', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Merryn', 'Initials': 'M', 'LastName': 'Voysey', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Maheshi N', 'Initials': 'MN', 'LastName': 'Ramasamy', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK. Electronic address: maheshi.ramasamy@paediatrics.ox.ac.uk.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Pollard', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(21)00628-0'] 2712,33798466,"Efficacy and safety of volanesorsen in patients with multifactorial chylomicronaemia (COMPASS): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial.","BACKGROUND Volanesorsen is an antisense oligonucleotide that targets hepatic apolipoprotein C-III synthesis and reduces plasma triglyceride concentration. The aim of this study was to explore the safety and efficacy of volanesorsen in patients with multifactorial chylomicronaemia syndrome. METHODS The COMPASS trial was a randomised, placebo-controlled, double-blind, phase 3 study done at 38 international clinical sites in Canada, France, Germany, the Netherlands, UK, and USA. Eligible patients were aged 18 years or older with multifactorial severe hypertriglyceridaemia or familial chylomicronaemia syndrome, who had a BMI of 45 kg/m 2 or less and fasting plasma triglyceride of 500 mg/dL or higher. Patients were randomly assigned (2:1) with an interactive response system using an allocation sequence and permuted block randomisation to receive subcutaneous volanesorsen (300 mg) or a matched volume of placebo (1·5 mL) once a week for 26 weeks. After 13 weeks of treatment, dosing was changed to 300 mg of volanesorsen or placebo every 2 weeks for all patients, except those who had completed 5 months or more of treatment as of May 27, 2016. Participants, investigators, sponsor personnel, and clinical research staff were all masked to the treatment assignments. The primary outcome was percentage change from baseline to 3 months in fasting triglyceride in the full analysis set (all patients who were randomly assigned and received at least one dose of study drug and had a baseline fasting triglyceride assessment). This trial is registered with ClinicalTrials.gov, NCT02300233 (completed). FINDINGS Between Feb 5, 2015, and Jan 24, 2017, 408 patients were screened for eligibility. 294 were excluded and 114 randomly assigned to receive either volanesorsen (n=76) or placebo (n=38). One patient in the volanesorsen group discontinued before receiving the study drug. The total number of dropouts was 28 (four in the placebo group and 24 in the treatment group). Volanesorsen reduced mean plasma triglyceride concentration by 71·2% (95% CI -79·3 to -63·2) from baseline to 3 months compared with 0·9% (-13·9 to 12·2) in the placebo group (p<0·0001), representing a mean absolute reduction of fasting plasma triglycerides of 869 mg/dL (95% CI -1018 to -720; 9·82 mmol/L [-11·51 to -8·14]) in volanesorsen compared with an increase in placebo of 74 mg/dL (-138 to 285; 0·83 mmol/L [-1·56 to 3·22]; p<0·0001). In the key safety analysis, five adjudicated events of acute pancreatitis occurred during the study treatment period, all in three of 38 patients in the placebo group. The most common adverse events were related to tolerability and included injection-site reactions (average of 24% of all volanesorsen injections vs 0·2% of placebo injections), which were all mild or moderate. One participant in the volanesorsen group had a platelet count reduction to less than 50 000 per μL and one patient had serum sickness, both of which were regarded as serious adverse events. INTERPRETATION Volanesorsen significantly reduced triglyceride concentrations in patients with multifactorial chlyomicronaemia and might reduce acute pancreatitis events in these patients. FUNDING Ionis Pharmaceuticals and Akcea Therapeutics.",2021,"The most common adverse events were related to tolerability and included injection-site reactions (average of 24% of all volanesorsen injections vs 0·2% of placebo injections), which were all mild or moderate.","['patients with multifactorial chylomicronaemia syndrome', 'patients with multifactorial chylomicronaemia (COMPASS', 'Eligible patients were aged 18 years or older with multifactorial severe hypertriglyceridaemia or familial chylomicronaemia syndrome, who had a BMI of 45 kg/m 2 or less and fasting plasma triglyceride of 500 mg/dL or higher', '38 international clinical sites in Canada, France, Germany, the Netherlands, UK, and USA', 'Between Feb 5, 2015, and Jan 24, 2017, 408 patients were screened for eligibility']","['interactive response system using an allocation sequence and permuted block randomisation to receive subcutaneous volanesorsen (300 mg) or a matched volume of placebo', 'volanesorsen', 'placebo', 'volanesorsen or placebo', 'dL']","['safety and efficacy', 'mean plasma triglyceride concentration', 'platelet count reduction', 'triglyceride concentrations', 'plasma triglyceride concentration', 'acute pancreatitis', 'percentage change from baseline to 3 months in fasting triglyceride', 'tolerability and included injection-site reactions', 'fasting plasma triglycerides', 'Efficacy and safety', 'total number of dropouts', 'acute pancreatitis events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0583329', 'cui_str': 'Plasma triglyceride measurement'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C4517769', 'cui_str': '408'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4726970', 'cui_str': 'Volanesorsen'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0583329', 'cui_str': 'Plasma triglyceride measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0001339', 'cui_str': 'Acute pancreatitis'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",408.0,0.737238,"The most common adverse events were related to tolerability and included injection-site reactions (average of 24% of all volanesorsen injections vs 0·2% of placebo injections), which were all mild or moderate.","[{'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Gouni-Berthold', 'Affiliation': 'Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Veronica J', 'Initials': 'VJ', 'LastName': 'Alexander', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, CA, USA.'}, {'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, CA, USA.'}, {'ForeName': 'Eunju', 'Initials': 'E', 'LastName': 'Hurh', 'Affiliation': 'Akcea Therapeutics, Cambridge, MA, USA.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Steinhagen-Thiessen', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Hospital Lipidambulanz, Berlin, Germany.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Moriarty', 'Affiliation': 'University of Kansas Medical Center, Lawrence, KS, USA.'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Hughes', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, CA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gaudet', 'Affiliation': 'Department of Medicine, Université de Montréal, Saguenay, QC, Canada.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Hegele', 'Affiliation': 'Robarts Research Institute, Western University, London, ON, Canada.'}, {'ForeName': 'Louis St L', 'Initials': 'LSL', 'LastName': ""O'Dea"", 'Affiliation': 'Akcea Therapeutics, Cambridge, MA, USA.'}, {'ForeName': 'Erik S G', 'Initials': 'ESG', 'LastName': 'Stroes', 'Affiliation': 'Department Vascular Medicine, Academic Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Sotirios', 'Initials': 'S', 'LastName': 'Tsimikas', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, CA, USA; Department of Medicine, University California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Witztum', 'Affiliation': 'Department of Medicine, University California San Diego, La Jolla, CA, USA. Electronic address: jwitztum@health.ucsd.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(21)00046-2'] 2713,33798465,Vitamin D supplementation to prevent acute respiratory infections: a systematic review and meta-analysis of aggregate data from randomised controlled trials.,"BACKGROUND A 2017 meta-analysis of data from 25 randomised controlled trials (RCTs) of vitamin D supplementation for the prevention of acute respiratory infections (ARIs) revealed a protective effect of this intervention. We aimed to examine the link between vitamin D supplementation and prevention of ARIs in an updated meta-analysis. METHODS For this systematic review and meta-analysis, we searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, Web of Science, and the ClinicalTrials.gov registry for studies listed from database inception to May 1, 2020. Double-blind RCTs of vitamin D 3 , vitamin D 2 , or 25-hydroxyvitamin D (25[OH]D) supplementation for any duration, with a placebo or low-dose vitamin D control, were eligible if they had been approved by a research ethics committee, and if ARI incidence was collected prospectively and prespecified as an efficacy outcome. Studies reporting results of long-term follow-up of primary RCTs were excluded. Aggregated study-level data, stratified by baseline 25(OH)D concentration and age, were obtained from study authors. Using the proportion of participants in each trial who had one or more ARIs, we did a random-effects meta-analysis to obtain pooled odds ratios (ORs) and 95% CIs to estimate the effect of vitamin D supplementation on the risk of having one or more ARIs (primary outcome) compared with placebo. Subgroup analyses were done to estimate whether the effects of vitamin D supplementation on the risk of ARI varied according to baseline 25(OH)D concentration (<25 nmol/L vs 25·0-49·9 nmol/L vs 50·0-74·9 nmol/L vs >75·0 nmol/L), vitamin D dose (daily equivalent of <400 international units [IU] vs 400-1000 IU vs 1001-2000 IU vs >2000 IU), dosing frequency (daily vs weekly vs once per month to once every 3 months), trial duration (≤12 months vs >12 months), age at enrolment (<1·00 years vs 1·00-15·99 years vs 16·00-64·99 years vs ≥65·00 years), and presence versus absence of airway disease (ie, asthma only, COPD only, or unrestricted). Risk of bias was assessed with the Cochrane Collaboration Risk of Bias Tool. The study was registered with PROSPERO, CRD42020190633. FINDINGS We identified 1528 articles, of which 46 RCTs (75 541 participants) were eligible. Data for the primary outcome were obtained for 48 488 (98·1%) of 49 419 participants (aged 0-95 years) in 43 studies. A significantly lower proportion of participants in the vitamin D supplementation group had one or more ARIs (14 332 [61·3%] of 23 364 participants) than in the placebo group (14 217 [62·3%] of 22 802 participants), with an OR of 0·92 (95% CI 0·86-0·99; 37 studies; I 2 =35·6%, p heterogeneity =0·018). No significant effect of vitamin D supplementation on the risk of having one or more ARIs was observed for any of the subgroups defined by baseline 25(OH)D concentration. However, protective effects of supplementation were observed in trials in which vitamin D was given in a daily dosing regimen (OR 0·78 [95% CI 0·65-0·94]; 19 studies; I 2 =53·5%, p heterogeneity =0·003), at daily dose equivalents of 400-1000 IU (0·70 [0·55-0·89]; ten studies; I 2 =31·2%, p heterogeneity =0·16), for a duration of 12 months or less (0·82 [0·72-0·93]; 29 studies; I 2 =38·1%, p heterogeneity =0·021), and to participants aged 1·00-15·99 years at enrolment (0·71 [0·57-0·90]; 15 studies; I 2 =46·0%, p heterogeneity =0·027). No significant interaction between allocation to the vitamin D supplementation group versus the placebo group and dose, dose frequency, study duration, or age was observed. In addition, no significant difference in the proportion of participants who had at least one serious adverse event in the vitamin supplementation group compared with the placebo group was observed (0·97 [0·86-1·07]; 36 studies; I 2 =0·0%, p heterogeneity =0·99). Risk of bias within individual studies was assessed as being low for all but three trials. INTERPRETATION Despite evidence of significant heterogeneity across trials, vitamin D supplementation was safe and overall reduced the risk of ARI compared with placebo, although the risk reduction was small. Protection was associated with administration of daily doses of 400-1000 IU for up to 12 months, and age at enrolment of 1·00-15·99 years. The relevance of these findings to COVID-19 is not known and requires further investigation. FUNDING None.",2021,"Despite evidence of significant heterogeneity across trials, vitamin D supplementation was safe and overall reduced the risk of ARI compared with placebo, although the risk reduction was small.","['1528 articles, of which 46 RCTs (75\u2009541 participants) were eligible']","['vitamin supplementation', 'Vitamin D supplementation', 'placebo or low-dose vitamin D control', 'vitamin D 3 , vitamin D 2 , or 25-hydroxyvitamin D (25[OH]D) supplementation', 'vitamin D', 'placebo', 'vitamin D supplementation']","['serious adverse event', 'risk of ARI', 'ARIs', 'acute respiratory infections', 'risk of having one or more ARIs']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0302837', 'cui_str': 'Vitamin supplement agent'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0014695', 'cui_str': 'Ergocalciferol'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0238990', 'cui_str': 'Acute lower respiratory tract infection'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}]",,0.8446,"Despite evidence of significant heterogeneity across trials, vitamin D supplementation was safe and overall reduced the risk of ARI compared with placebo, although the risk reduction was small.","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Jolliffe', 'Affiliation': 'Barts and The London School of Medicine and Dentistry, and Asthma UK Centre for Applied Research, Queen Mary University of London, London, UK. Electronic address: d.a.jolliffe@qmul.ac.uk.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Camargo', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Sluyter', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Aglipay', 'Affiliation': ""Department of Pediatrics, St Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Aloia', 'Affiliation': 'Bone Mineral Research Center, Winthrop University Hospital, Mineola, NY, USA.'}, {'ForeName': 'Davaasambuu', 'Initials': 'D', 'LastName': 'Ganmaa', 'Affiliation': 'Department of Nutrition, Harvard TH Chan Shool of Public Health, Boston, MA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bergman', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Heike A', 'Initials': 'HA', 'LastName': 'Bischoff-Ferrari', 'Affiliation': 'Department of Geriatric Medicine and Aging Research, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Borzutzky', 'Affiliation': 'Department of Pediatric Infectious Diseases and Immunology, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Camilla T', 'Initials': 'CT', 'LastName': 'Damsgaard', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Gal', 'Initials': 'G', 'LastName': 'Dubnov-Raz', 'Affiliation': ""Exercise, Lifestyle and Nutrition Clinic, Edmond and Lily Safra Children's Hospital, Tel Hashomer, Israel.""}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Esposito', 'Affiliation': 'Paediatric Clinic, Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Gilham', 'Affiliation': 'Department of Non-Communicable Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Adit A', 'Initials': 'AA', 'LastName': 'Ginde', 'Affiliation': 'Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Inbal', 'Initials': 'I', 'LastName': 'Golan-Tripto', 'Affiliation': 'Saban Pediatric Medical Center, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University, Beer Sheva, Israel.'}, {'ForeName': 'Emma C', 'Initials': 'EC', 'LastName': 'Goodall', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Cameron C', 'Initials': 'CC', 'LastName': 'Grant', 'Affiliation': 'Department of Paediatrics: Child and Youth Health, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Griffiths', 'Affiliation': 'Barts and The London School of Medicine and Dentistry, and Asthma UK Centre for Applied Research, Queen Mary University of London, London, UK.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Hibbs', 'Affiliation': ""Department of Pediatrics, Case Western Reserve University School of Medicine, Cleveland, OH, USA; University Hospitals Rainbow Babies and Children's Hospital, Cleveland, OH, USA.""}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Janssens', 'Affiliation': 'Universitair Ziekenhuis Leuven, Leuven, Belgium.'}, {'ForeName': 'Anuradha Vaman', 'Initials': 'AV', 'LastName': 'Khadilkar', 'Affiliation': 'Hirabai Cowasji Jehangir Medical Research Institute, Maharashtra, India.'}, {'ForeName': 'Ilkka', 'Initials': 'I', 'LastName': 'Laaksi', 'Affiliation': 'Faculty of Medicine and Health Technology, University of Tampere, Tampere, Finland; Centre for Military Medicine, Helsinki, Finland.'}, {'ForeName': 'Margaret T', 'Initials': 'MT', 'LastName': 'Lee', 'Affiliation': 'Division of Pediatric Hematology, Oncology, and Stem Cell Transplantation, Columbia University Medical Center, New York, NY USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Loeb', 'Affiliation': 'Department of Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Jonathon L', 'Initials': 'JL', 'LastName': 'Maguire', 'Affiliation': ""Department of Pediatrics, St Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Majak', 'Affiliation': 'Department of Pediatric Pulmonology, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Mauger', 'Affiliation': 'Department of Statistics, The Pennsylvania State University, Hershey, PA, USA.'}, {'ForeName': 'Semira', 'Initials': 'S', 'LastName': 'Manaseki-Holland', 'Affiliation': 'Department of Public Health, Epidemiology and Biostatistics, Institute of Applied Health Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Murdoch', 'Affiliation': 'Department of Pathology, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Nakashima', 'Affiliation': 'Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Neale', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, QLD, Australia.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Pham', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, QLD, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Rake', 'Affiliation': 'Department of Non-Communicable Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Judy R', 'Initials': 'JR', 'LastName': 'Rees', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Lebanon, NH, USA.'}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Rosendahl', 'Affiliation': ""Children's Hospital, Pediatric Research Centre, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Scragg', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Dheeraj', 'Initials': 'D', 'LastName': 'Shah', 'Affiliation': 'Department of Paediatrics, University College of Medical Sciences, Delhi, India.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Shimizu', 'Affiliation': 'FANCL Research Institute, FANCL Corporation, Yokohama, Japan.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Simpson-Yap', 'Affiliation': 'Neuroepidemiology Unit, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, VIC, Australia; Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia.'}, {'ForeName': 'Geeta', 'Initials': 'G', 'LastName': 'Trilok-Kumar', 'Affiliation': 'Institute of Home Economics, University of Delhi, New Delhi, India.'}, {'ForeName': 'Mitsuyoshi', 'Initials': 'M', 'LastName': 'Urashima', 'Affiliation': 'Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Adrian R', 'Initials': 'AR', 'LastName': 'Martineau', 'Affiliation': 'Barts and The London School of Medicine and Dentistry, and Asthma UK Centre for Applied Research, Queen Mary University of London, London, UK. Electronic address: a.martineau@qmul.ac.uk.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(21)00051-6'] 2714,33797983,Effect of Delayed-Release and Extended-Release Methylphenidate on Caregiver Strain and Validation of Psychometric Properties of the Caregiver Strain Questionnaire: Results from a Phase 3 Trial in Children with Attention-Deficit/Hyperactivity Disorder.,"Objectives: Inadequately controlled symptoms and associated impaired functioning have a significant negative impact on caregivers of children with attention-deficit/hyperactivity disorder (ADHD). This study aimed to assess the impact of evening-dosed, delayed-release, and extended-release methylphenidate (DR/ER-MPH) treatment on caregiver strain, measured by the Caregiver Strain Questionnaire (CGSQ), and present post hoc psychometric analyses assessing the reliability and validity of the CGSQ, its ability to detect change (responsiveness), and to derive responder definitions. Methods: The CGSQ was an exploratory efficacy endpoint in a phase 3, 3-week, randomized, double-blind, multicenter, placebo-controlled, forced-dose titration trial of DR/ER-MPH in children aged 6-12 years with ADHD (NCT02520388). Psychometric properties of the CGSQ evaluated post hoc included internal consistency using Cronbach's alpha; test/retest reliability using intraclass correlation coefficients (ICCs); construct validity (known groups and convergent/divergent validity); responsiveness to changes in assessments of ADHD severity (ADHD Rating Scale-IV [ADHD-RS-IV], Conners' Global Index-Parent [CGI-P], and Clinical Global Impression-Severity [CGI-S]/CGI-Improvement [CGI-I]); and meaningful change threshold (MCT) using receiver operating characteristic curves, which were used to compare response between DR/ER-MPH and placebo groups. Results: Randomized DR/ER-MPH (54.5) and placebo (54.9) groups had similar mean CGSQ scores at screening. Caregivers of children on DR/ER-MPH reported significant reductions in CGSQ scores after 3 weeks of DR/ER-MPH treatment versus placebo (least-squares mean: 41.2 vs. 49.1; p  < 0.001). The CGSQ demonstrated strong internal consistency (Cronbach's alpha = 0.93) and good test/retest reliability (ICC = 0.72). Known groups, convergent/divergent validity, and responsiveness were demonstrated from relationships between the CGSQ and the CGI-S, ADHD-RS-IV, and CGI-P. The mean anchor-based MCT for CGSQ total score was estimated as -9.0 (DR/ER-MPH vs. placebo: 53.2% vs. 29.9% p  = 0.003). Conclusions: CGSQ scores significantly decreased after 3 weeks of DR/ER-MPH treatment versus placebo, and the CGSQ was found to be a valid and reliable measure of strain in caregivers of children with ADHD. Clinical trial registration identification number: NCT02520388.",2021,Caregivers of children on DR/ER-MPH reported significant reductions in CGSQ scores after 3 weeks of DR/ER-MPH treatment versus placebo (least-squares mean: 41.2 vs. 49.1; p  < 0.001).,"['children aged 6-12 years with ADHD (NCT02520388', 'caregivers of children with ADHD', 'Children with Attention-Deficit/Hyperactivity Disorder', 'caregivers of children with attention-deficit/hyperactivity disorder (ADHD']","['placebo', 'evening-dosed, delayed-release, and extended-release methylphenidate (DR/ER-MPH', 'Delayed-Release and Extended-Release Methylphenidate']","['mean CGSQ scores', 'mean anchor-based MCT for CGSQ total score', 'Caregiver Strain Questionnaire (CGSQ', ""ADHD severity (ADHD Rating Scale-IV [ADHD-RS-IV], Conners' Global Index-Parent [CGI-P], and Clinical Global Impression-Severity [CGI-S]/CGI-Improvement [CGI-I]); and meaningful change threshold (MCT"", 'CGSQ scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026687', 'cui_str': 'Mucociliary clearance'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",,0.132056,Caregivers of children on DR/ER-MPH reported significant reductions in CGSQ scores after 3 weeks of DR/ER-MPH treatment versus placebo (least-squares mean: 41.2 vs. 49.1; p  < 0.001).,"[{'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'López', 'Affiliation': 'Pediatric Neurology, P.A., Winter Park, Florida, USA.'}, {'ForeName': 'Stephen V', 'Initials': 'SV', 'LastName': 'Faraone', 'Affiliation': 'Departments of Psychiatry and of Neuroscience and Physiology, State University of New York (SUNY) Upstate Medical University, Syracuse, New York, USA.'}, {'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Newcorn', 'Affiliation': 'Mount Sinai Medical Center, New York, New York, USA.'}, {'ForeName': 'Helen A', 'Initials': 'HA', 'LastName': 'Doll', 'Affiliation': 'Clinical Outcomes Assessments, ICON plc, Oxford, United Kingdom.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Rhoten', 'Affiliation': 'Patient Centered Outcomes, ICON plc, South San Francisco, California, USA.'}, {'ForeName': 'Hannah B', 'Initials': 'HB', 'LastName': 'Lewis', 'Affiliation': 'Patient Centred Outcomes, ICON plc, London, United Kingdom.'}, {'ForeName': 'Tayyaba F', 'Initials': 'TF', 'LastName': 'Khan', 'Affiliation': 'Highland Therapeutics, Inc., Toronto, Canada.'}, {'ForeName': 'Norberto J', 'Initials': 'NJ', 'LastName': 'DeSousa', 'Affiliation': 'Ironshore Pharmaceuticals & Development, Inc., Camana Bay, Grand Cayman, Cayman Islands.'}, {'ForeName': 'Floyd R', 'Initials': 'FR', 'LastName': 'Sallee', 'Affiliation': 'Ironshore Pharmaceuticals, Inc., Durham, North Carolina, USA.'}, {'ForeName': 'Bev', 'Initials': 'B', 'LastName': 'Incledon', 'Affiliation': 'Ironshore Pharmaceuticals & Development, Inc., Camana Bay, Grand Cayman, Cayman Islands.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2020.0159'] 2715,33770739,Effectiveness of empathic caring on stress and depression for women with recurrent miscarriage: A randomized controlled trial.,"AIM The purpose of this study was to investigate the effectiveness of empathic caring on sleep quality, depression, stress, and social support in women with recurrent miscarriage. MATERIALS AND METHODS Sixty-two eligible women were randomly assigned to either the experimental group (n = 31), which received three face-to-face nursing counseling sessions, or the control group (n = 31). Outcome measures included the Pittsburgh Sleep Quality Index, Edinburgh Prenatal Depression Scale, Perceived Stress Scale, and Interpersonal Support Evaluation List. RESULTS Paired-sample t-tests revealed that, after receiving nursing counseling, the participants in the experimental group showed significant decreases in stress and depression. However, no significant mean differences were found in the control group between the pretest and the 12-week posttest for any of the four outcome measures. CONCLUSION Clinical healthcare professionals may incorporate empathic caring into health-promotion protocols to assist women with recurrent miscarriage to improve their psychosocial health.",2021,"Outcome measures included the Pittsburgh Sleep Quality Index, Edinburgh Prenatal Depression Scale, Perceived Stress Scale, and Interpersonal Support Evaluation List. ","['women with recurrent miscarriage', 'Sixty-two eligible women']",['empathic caring'],"['sleep quality, depression, stress, and social support', 'stress and depression', 'Pittsburgh Sleep Quality Index, Edinburgh Prenatal Depression Scale, Perceived Stress Scale, and Interpersonal Support Evaluation List']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0000809', 'cui_str': 'Recurrent miscarriage'}, {'cui': 'C4517835', 'cui_str': '62'}]",[],"[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]",62.0,0.0533335,"Outcome measures included the Pittsburgh Sleep Quality Index, Edinburgh Prenatal Depression Scale, Perceived Stress Scale, and Interpersonal Support Evaluation List. ","[{'ForeName': 'Shu-Chen', 'Initials': 'SC', 'LastName': 'Chang', 'Affiliation': 'Department of Emergency Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan. Electronic address: csj52@mail.ncku.edu.tw.'}, {'ForeName': 'Pao-Lin', 'Initials': 'PL', 'LastName': 'Kuo', 'Affiliation': 'Department of Obstetrics and Gynecology, College of Medicine, National Cheng-Kung University, Tainan, Taiwan. Electronic address: paolinkuo@gmail.com.'}, {'ForeName': 'Chung-Hey', 'Initials': 'CH', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, Hungkuang University, Taichung, Taiwan; Department of Nursing & Institute of Allied Health Sciences, National Cheng Kung University, Tainan, Taiwan. Electronic address: chunghey@ncku.edu.tw.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101367'] 2716,33770710,"High frequency repetitive transcranial magnetic stimulation of dorsomedial prefrontal cortex for negative symptoms in patients with schizophrenia: A double-blind, randomized controlled trial.","Negative symptoms are the major challenge in clinical management of schizophrenia. Dorsomedial prefrontal cortex (DMPFC) has been suggested to be highly involved in the mechanisms of negative symptoms of schizophrenia. However, the effect of repetitive Transcranial Magnetic Stimulation (rTMS) over DMPFC has not yet been well studied. In this double-blind, randomized controlled rTMS clinical trial, thirty-three participants (17 in active group and 16 in sham group) were enrolled. This study includes the rTMS treatment phase (lasts for 4 weeks) and a subsequently naturalistic follow-up phase (lasts for another 4 weeks). Schizophrenia patients with prominently negative symptoms were randomly assigned to receive 10 Hz or sham rTMS intervention. The score change in Scale of Negative Symptoms (SANS) was defined as the primary outcome measure. There was a significant decrease in negative symptoms, especially affective flattening and anhedonia in schizophrenia patients after DMPFC-rTMS intervention. Moreover, the negative symptoms improvement could maintain at least another 4 weeks. In addition, no memory impairment or serious adverse reaction of rTMS emerged. Our results suggest that high frequency rTMS over DMPF may represent a safe and effective treatment for negative symptoms in patients with schizophrenia.",2021,"There was a significant decrease in negative symptoms, especially affective flattening and anhedonia in schizophrenia patients after DMPFC-rTMS intervention.","['thirty-three participants (17 in active group and 16 in sham group) were enrolled', 'patients with schizophrenia', 'Schizophrenia patients with prominently negative symptoms']","['repetitive Transcranial Magnetic Stimulation (rTMS', 'High frequency repetitive transcranial magnetic stimulation of dorsomedial prefrontal cortex', '10 Hz or sham rTMS intervention']","['score change in Scale of Negative Symptoms (SANS', 'negative symptoms, especially affective flattening and anhedonia']","[{'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}]",33.0,0.0736496,"There was a significant decrease in negative symptoms, especially affective flattening and anhedonia in schizophrenia patients after DMPFC-rTMS intervention.","[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Gan', 'Affiliation': 'First-episode Schizophrenia and Early Psychosis Program, Division of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Junjuan', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of EEG and Imaging, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Kaiming', 'Initials': 'K', 'LastName': 'Zhuo', 'Affiliation': 'First-episode Schizophrenia and Early Psychosis Program, Division of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jianye', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Imaging, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Department of EEG and Imaging, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhenying', 'Initials': 'Z', 'LastName': 'Qian', 'Affiliation': 'Department of EEG and Imaging, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Xiang', 'Affiliation': 'First-episode Schizophrenia and Early Psychosis Program, Division of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'First-episode Schizophrenia and Early Psychosis Program, Division of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'First-episode Schizophrenia and Early Psychosis Program, Division of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jinhong', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Imaging, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jijun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of EEG and Imaging, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China. Electronic address: jijunwang27@163.com.'}, {'ForeName': 'Dengtang', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'First-episode Schizophrenia and Early Psychosis Program, Division of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Institute of Mental Health, Fudan University, Shanghai, China. Electronic address: liudengtang@smhc.org.cn.'}]",Psychiatry research,['10.1016/j.psychres.2021.113876'] 2717,33769998,Outcomes of Ambulatory Heart Failure Patients Managed With an Intra-aortic Balloon Pump Before Left Ventricular Assist Device Implantation.,"Patients are admitted to the hospital for hemodynamic optimization before left ventricular assist device (LVAD) implantation. The aim of this study was to evaluate the clinical outcomes of hemodynamic optimization using an intra-aortic balloon pump (IABP) in ambulatory heart failure patients before LVAD placement. This retrospective single-center study included 199 noninotrope-dependent patients who underwent durable LVAD implantation between January 1, 2007 and April 10, 2017. Invasive hemodynamic as well as the primary composite end-point of stage 2 or 3 acute kidney injury, right ventricular failure, and 30-day mortality were compared between patients with and without an IABP. Median age was 64 (interquartile range [IQR], 57-71) years and 165 (82.9%) were male; 72 (36.2%) received an IABP. Patients treated with an IABP had worse baseline exercise capacity and hemodynamic parameters. Patients with an IABP had greater relative reduction in pulmonary artery mean pressure (-16% vs. -2%; p ≤ 0.001). The primary composite end-point was not different between patients who had an IABP and those who did not (20.8% vs. 20.5%; p = 0.952), as were each of the individual end-points. Despite worse baseline hemodynamic parameters and exercise capacity, ambulatory heart failure patients who received an IABP before LVAD implantation had more favorable reductions in pulmonary artery pressures without an increase in the composite end-point. These results suggest that IABP use before LVAD implantation may mitigate the risk of postoperative complications in ambulatory patients.",2021,Patients with an IABP had greater relative reduction in pulmonary artery mean pressure (-16% vs. -2%; p ≤ 0.001).,"['ambulatory heart failure patients before LVAD placement', 'Patients are admitted to the hospital for hemodynamic optimization before left ventricular assist device (LVAD) implantation', 'ambulatory patients', 'Median age was 64 (interquartile range [IQR], 57-71) years and 165 (82.9%) were male; 72 (36.2%) received an', '199 noninotrope-dependent patients who underwent durable LVAD implantation between January 1, 2007 and April 10, 2017']","['LVAD implantation', 'Ambulatory Heart Failure Patients Managed With an Intra-aortic Balloon Pump', 'intra-aortic balloon pump (IABP', 'IABP', 'IABP before LVAD implantation']","['pulmonary artery pressures', 'pulmonary artery mean pressure', 'right ventricular failure, and 30-day mortality', 'postoperative complications', 'Invasive hemodynamic', 'baseline exercise capacity and hemodynamic parameters']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0021860', 'cui_str': 'Cardioassist by aortic balloon pump'}]","[{'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0428645', 'cui_str': 'Pulmonary artery mean pressure'}, {'cui': 'C0235527', 'cui_str': 'Right heart failure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.14911,Patients with an IABP had greater relative reduction in pulmonary artery mean pressure (-16% vs. -2%; p ≤ 0.001).,"[{'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Ternus', 'Affiliation': 'From the Division of Cardiovascular Medicine, University of Wisconsin-Madison, Wisconsin.'}, {'ForeName': 'Atta', 'Initials': 'A', 'LastName': 'Behfar', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Schirger', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Barsness', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Mackram', 'Initials': 'M', 'LastName': 'Eleid', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Parag', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Stulak', 'Affiliation': 'Division of Cardiovascular Surgery, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Jentzer', 'Affiliation': 'From the Division of Cardiovascular Medicine, University of Wisconsin-Madison, Wisconsin.'}]",ASAIO journal (American Society for Artificial Internal Organs : 1992),['10.1097/MAT.0000000000001249'] 2718,33769849,Effect of Training With Anchors on Auditory-Perceptual Evaluation of Dysphonia in Speech-Language Pathology Students.,"Purpose Auditory-perceptual evaluation is essential for the clinical assessment of voice disorders. Unstable perceptual voice evaluation has been shown for inexperienced listeners as compared to expert listeners. We examined the effects of perceptual training with external auditory anchors with and without immediate feedback on the evaluation of roughness and breathiness of natural, nonsynthesized speech stimuli (reading of a standard passage) in speech-language pathology students. Method Perceptual voice evaluation and training with anchors using a visual analog scale was implemented with a computer software. Forty-eight speech-language pathology students were randomly assigned into three groups, feedback group (Group F), no feedback group (Group NF), and control group (Group C), attending one training session and four assessment sessions (before training, immediately after training, and 1 and 7 weeks after training). Group F received training with anchors with immediate feedback, Group NF received training without immediate feedback, and Group C received sham training (exposure session). Results Training with anchors significantly increased the rating accuracy (agreement with expert ratings) on both roughness and breathiness for Group F, with the effects lasting for 7 weeks. No significant changes in rating accuracy with training were observed for Group NF and Group C. No improvements in intra- and interrater reliability as well as intrarater agreement were observed in all three groups, whereas interrater agreement on breathiness (but not roughness) significantly increased for all groups, with the effect lasting for 7 weeks only for Group F. Conclusions These findings suggested that perceptual training with external auditory anchors and the use of immediate feedback could be effective for facilitating the development of perceptual voice evaluation skills in speech-language pathology students. Further studies involving more extensive training with stimuli covering a full range of dysphonia severity categories and improvements in design of the training protocol are recommended to verify these results.",2021,"Results Training with anchors significantly increased the rating accuracy (agreement with expert ratings) on both roughness and breathiness for Group F, with the effects lasting for 7 weeks.","['Speech-Language Pathology Students', 'speech-language pathology students', 'Forty-eight speech-language pathology students']","['feedback group (Group F), no feedback group (Group NF), and control group (Group C), attending one training session and four assessment sessions', 'Method Perceptual voice evaluation and training with anchors using a visual analog scale', 'Training With Anchors on Auditory-Perceptual Evaluation of Dysphonia', 'perceptual training with external auditory anchors with and without immediate feedback', 'training with anchors with immediate feedback, Group NF received training without immediate feedback, and Group C received sham training (exposure session', 'natural, nonsynthesized speech stimuli (reading of a standard passage']","['intra- and interrater reliability', 'rating accuracy']","[{'cui': 'C0037825', 'cui_str': 'Pathology, Speech-Language'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4319608', 'cui_str': '48'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441840', 'cui_str': 'Group F'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0556503', 'cui_str': 'Perceptual training'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439799', 'cui_str': 'Channel'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",,0.0037826,"Results Training with anchors significantly increased the rating accuracy (agreement with expert ratings) on both roughness and breathiness for Group F, with the effects lasting for 7 weeks.","[{'ForeName': 'Denise Wai-Man', 'Initials': 'DW', 'LastName': 'Wong', 'Affiliation': 'Department of Speech Language Pathology and Audiology, National Taipei University of Nursing and Health Sciences, Taiwan.'}, {'ForeName': 'Roger W', 'Initials': 'RW', 'LastName': 'Chan', 'Affiliation': 'Department of Speech Language Pathology and Audiology, National Taipei University of Nursing and Health Sciences, Taiwan.'}, {'ForeName': 'Chia-Hsin', 'Initials': 'CH', 'LastName': 'Wu', 'Affiliation': 'Department of Speech Language Pathology and Audiology, National Taipei University of Nursing and Health Sciences, Taiwan.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2020_JSLHR-20-00214'] 2719,33772220,Discordant results between conventional newborn screening and genomic sequencing in the BabySeq Project.,"PURPOSE Newborn screening (NBS) is performed to identify neonates at risk for actionable, severe, early-onset disorders, many of which are genetic. The BabySeq Project randomized neonates to receive conventional NBS or NBS plus exome sequencing (ES) capable of detecting sequence variants that may also diagnose monogenic disease or indicate genetic disease risk. We therefore evaluated how ES and conventional NBS results differ in this population. METHODS We compared results of NBS (including hearing screens) and ES for 159 infants in the BabySeq Project. Infants were considered ""NBS positive"" if any abnormal result was found indicating disease risk and ""ES positive"" if ES identified a monogenic disease risk or a genetic diagnosis. RESULTS Most infants (132/159, 84%) were NBS and ES negative. Only one infant was positive for the same disorder by both modalities. Nine infants were NBS positive/ES negative, though seven of these were subsequently determined to be false positives. Fifteen infants were ES positive/NBS negative, all of which represented risk of genetic conditions that are not included in NBS programs. No genetic explanation was identified for eight infants referred on the hearing screen. CONCLUSION These differences highlight the complementarity of information that may be gleaned from NBS and ES in the newborn period.",2021,"No genetic explanation was identified for eight infants referred on the hearing screen. ","['159 infants in the BabySeq Project', 'eight infants referred on the hearing screen']","['Newborn screening (NBS', 'NBS', 'conventional NBS or NBS plus exome sequencing (ES']",['NBS and ES negative'],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0027617', 'cui_str': 'Neonatal screening'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3640077', 'cui_str': 'Complete Exome Sequencing'}]","[{'cui': 'C0027617', 'cui_str': 'Neonatal screening'}, {'cui': 'C3640077', 'cui_str': 'Complete Exome Sequencing'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",15.0,0.072564,"No genetic explanation was identified for eight infants referred on the hearing screen. ","[{'ForeName': 'Monica H', 'Initials': 'MH', 'LastName': 'Wojcik', 'Affiliation': ""Division of Genetics and Genomics, The Manton Center for Orphan Disease Research, Boston Children's Hospital, and Department of Pediatrics, Harvard Medical School, Boston, MA, USA. monica.wojcik@childrens.harvard.edu.""}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': ""Division of Genetics and Genomics, The Manton Center for Orphan Disease Research, Boston Children's Hospital, and Department of Pediatrics, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Ozge', 'Initials': 'O', 'LastName': 'Ceyhan-Birsoy', 'Affiliation': 'Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Casie A', 'Initials': 'CA', 'LastName': 'Genetti', 'Affiliation': ""Division of Genetics and Genomics, The Manton Center for Orphan Disease Research, Boston Children's Hospital, and Department of Pediatrics, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Lebo', 'Affiliation': 'Laboratory for Molecular Medicine, Partners HealthCare Personalized Medicine, Cambridge, MA, USA.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Yu', 'Affiliation': ""Division of Genetics and Genomics, The Manton Center for Orphan Disease Research, Boston Children's Hospital, and Department of Pediatrics, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Parad', 'Affiliation': ""Department of Pediatric Newborn Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Ingrid A', 'Initials': 'IA', 'LastName': 'Holm', 'Affiliation': ""Division of Genetics and Genomics, The Manton Center for Orphan Disease Research, Boston Children's Hospital, and Department of Pediatrics, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Heidi L', 'Initials': 'HL', 'LastName': 'Rehm', 'Affiliation': 'Medical and Population Genetics, Broad Institute of MIT and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Alan H', 'Initials': 'AH', 'LastName': 'Beggs', 'Affiliation': ""Division of Genetics and Genomics, The Manton Center for Orphan Disease Research, Boston Children's Hospital, and Department of Pediatrics, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Green', 'Affiliation': 'Medical and Population Genetics, Broad Institute of MIT and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Pankaj B', 'Initials': 'PB', 'LastName': 'Agrawal', 'Affiliation': ""Division of Genetics and Genomics, The Manton Center for Orphan Disease Research, Boston Children's Hospital, and Department of Pediatrics, Harvard Medical School, Boston, MA, USA. pagrawal@enders.tch.harvard.edu.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Genetics in medicine : official journal of the American College of Medical Genetics,['10.1038/s41436-021-01146-5'] 2720,33771833,CHILD-BRIGHT READYorNot Brain-Based Disabilities Trial: protocol of a randomised controlled trial (RCT) investigating the effectiveness of a patient-facing e-health intervention designed to enhance healthcare transition readiness in youth.,"INTRODUCTION Youth with brain-based disabilities (BBDs), as well as their parents/caregivers, often feel ill-prepared for the transfer from paediatric to adult healthcare services. To address this pressing issue, we developed the MyREADY Transition TM BBD App, a patient-facing e-health intervention. The primary aim of this randomised controlled trial (RCT) was to determine whether the App will result in greater transition readiness compared with usual care for youth with BBD. Secondary aims included exploring the contextual experiences of youth using the App, as well as the interactive processes of youth, their parents/caregivers and healthcare providers around use of the intervention. METHODS AND ANALYSIS We aimed to randomise 264 youth with BBD between 15 and 17 years of age, to receive existing services/usual care (control group) or to receive usual care along with the App (intervention group). Our recruitment strategy includes remote and virtual options in response to the current requirements for physical distancing due to the COVID-19 pandemic. We will use an embedded experimental model design which involves embedding a qualitative study within a RCT. The Transition Readiness Assessment Questionnaire will be administered as the primary outcome measure. Analysis of covariance will be used to compare change in the two groups on the primary outcome measure; analysis will be intention-to-treat. Interviews will be conducted with subsets of youth in the intervention group, as well as parents/caregivers and healthcare providers. ETHICS AND DISSEMINATION The study has been approved by the research ethics board of each participating site in four different regions in Canada. We will leverage our patient and family partnerships to find novel dissemination strategies. Study findings will be shared with the academic and stakeholder community, including dissemination of teaching and training tools through patient associations, and patient and family advocacy groups. TRIAL REGISTRATION NUMBER NCT03852550.",2021,The primary aim of this randomised controlled trial (RCT) was to determine whether the App will result in greater transition readiness compared with usual care for youth with BBD.,"['youth', 'youth with BBD', 'Youth with brain-based disabilities (BBDs', '264 youth with BBD between 15 and 17 years of age, to receive']","['patient-facing e-health intervention', 'existing services/usual care (control group) or to receive usual care along with the App (intervention group']",[],"[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],,0.11803,The primary aim of this randomised controlled trial (RCT) was to determine whether the App will result in greater transition readiness compared with usual care for youth with BBD.,"[{'ForeName': 'Jan Willem', 'Initials': 'JW', 'LastName': 'Gorter', 'Affiliation': 'CanChild, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada gorter@mcmaster.ca.'}, {'ForeName': 'Khush', 'Initials': 'K', 'LastName': 'Amaria', 'Affiliation': 'CBT Associates of Toronto Cognitive Behavioural Therapy Services, Toronto, Ontario, Canada.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Kovacs', 'Affiliation': 'Knight Cardiovascular Institute, Oregon Health & Science Univeristy, Portland, Oregon, USA.'}, {'ForeName': 'Ronen', 'Initials': 'R', 'LastName': 'Rozenblum', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Galuppi', 'Affiliation': 'CanChild, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Nguyen', 'Affiliation': 'CanChild, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Strohm', 'Affiliation': 'CanChild, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Nadilein', 'Initials': 'N', 'LastName': 'Mahlberg', 'Affiliation': 'CanChild, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Via-Dufresne Ley', 'Affiliation': 'The Research Institute of the McGill University Health Centre (RI-MUHC), Montreal, Quebec, Canada.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Marelli', 'Affiliation': 'Department of Medicine, Faculty of Medicine, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2021-048756'] 2721,33771832,"Clinical and cost-effectiveness of bracing in symptomatic knee osteoarthritis management: protocol for a multicentre, primary care, randomised, parallel-group, superiority trial.","BACKGROUND Brace effectiveness for knee osteoarthritis (OA) remains unclear and international guidelines offer conflicting recommendations. Our trial will determine the clinical and cost-effectiveness of adding knee bracing (matched to patients' clinical and radiographic presentation and with adherence support) to a package of advice, written information and exercise instruction delivered by physiotherapists. METHODS AND ANALYSIS A multicentre, pragmatic, two-parallel group, single-blind, superiority, randomised controlled trial with internal pilot and nested qualitative study. 434 eligible participants with symptomatic knee OA identified from general practice, physiotherapy referrals and self-referral will be randomised 1:1 to advice, written information and exercise instruction and knee brace versus advice, written information and exercise instruction alone. The primary analysis will be intention-to-treat comparing treatment arms on the primary outcome (Knee Osteoarthritis Outcomes Score (KOOS)-5) (composite knee score) at the primary endpoint (6 months) adjusted for prespecified covariates. Secondary analysis of KOOS subscales (pain, other symptoms, activities of daily living, function in sport and recreation, knee-related quality of life), self-reported pain, instability (buckling), treatment response, physical activity, social participation, self-efficacy and treatment acceptability will occur at 3, 6, and 12 months postrandomisation. Analysis of covariance and logistic regression will model continuous and dichotomous outcomes, respectively. Treatment effect estimates will be presented as mean differences or ORs with 95% CIs. Economic evaluation will estimate cost-effectiveness. Semistructured interviews to explore acceptability and experiences of trial interventions will be conducted with participants and physiotherapists delivering interventions. ETHICS AND DISSEMINATION North West Preston Research Ethics Committee, the Health Research Authority and Health and Care Research in Wales approved the study (REC Reference: 19/NW/0183; IRAS Reference: 247370). This protocol has been coproduced with stakeholders including patients and public. Findings will be disseminated to patients and a range of stakeholders. TRIAL REGISTRATION NUMBER ISRCTN28555470.",2021,"Secondary analysis of KOOS subscales (pain, other symptoms, activities of daily living, function in sport and recreation, knee-related quality of life), self-reported pain, instability (buckling), treatment response, physical activity, social participation, self-efficacy and treatment acceptability will occur at 3, 6, and 12 months postrandomisation.","['knee osteoarthritis (OA', '434 eligible participants with symptomatic knee OA identified from general practice, physiotherapy referrals and self-referral', 'symptomatic knee osteoarthritis management']","['knee bracing', 'advice, written information and exercise instruction and knee brace versus advice, written information and exercise instruction alone']","['KOOS subscales (pain, other symptoms, activities of daily living, function in sport and recreation, knee-related quality of life), self-reported pain, instability (buckling), treatment response, physical activity, social participation, self-efficacy and treatment acceptability', 'primary outcome (Knee Osteoarthritis Outcomes Score (KOOS)-5) (composite knee score']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0237824', 'cui_str': 'Self-referral'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C1828220', 'cui_str': 'Application of brace'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0006086', 'cui_str': 'Brace'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0034872', 'cui_str': 'Recreation'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0814554', 'cui_str': 'Social Participation'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",434.0,0.187243,"Secondary analysis of KOOS subscales (pain, other symptoms, activities of daily living, function in sport and recreation, knee-related quality of life), self-reported pain, instability (buckling), treatment response, physical activity, social participation, self-efficacy and treatment acceptability will occur at 3, 6, and 12 months postrandomisation.","[{'ForeName': 'Melanie A', 'Initials': 'MA', 'LastName': 'Holden', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, UK m.holden@keele.ac.uk.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Callaghan', 'Affiliation': 'Faculty of Health, Psychology & Social Care, Manchester Metropolitan University, Manchester, Greater Manchester, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Felson', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Fraser', 'Initials': 'F', 'LastName': 'Birrell', 'Affiliation': 'Medical Research Council Versus Arthritis Centre for Integrated Research into Musculoskeletal Ageing, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Nicholls', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Jowett', 'Affiliation': 'Health Economics Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kigozi', 'Affiliation': 'Health Economics Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McBeth', 'Affiliation': 'Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, Manchester, UK.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Borrelli', 'Affiliation': 'Henry M. Goldman School of Dental Medicine, Boston University, Boston, Massachusetts, USA.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Jinks', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, UK.'}, {'ForeName': 'Nadine E', 'Initials': 'NE', 'LastName': 'Foster', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, UK.'}, {'ForeName': 'Krysia', 'Initials': 'K', 'LastName': 'Dziedzic', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mallen', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, UK.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Ingram', 'Affiliation': 'Research User Group, Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Sutton', 'Affiliation': 'Research User Group, Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lawton', 'Affiliation': 'Clinical Trials Unit, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Halliday', 'Affiliation': 'Clinical Trials Unit, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Hartshorne', 'Affiliation': 'Clinical Trials Unit, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Williams', 'Affiliation': 'Research in OsteoArthritis Manchester (ROAM), Centre for Epidemiology Versus Arthritis, Centre for Musculoskeletal Research, Institute of Inflammation and Repair, The University of Manchester, Manchester, Manchester, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Browell', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, North Shields, Tyne and Wear, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Hudson', 'Affiliation': 'Clinical Trials Unit, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Marshall', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, UK.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Sowden', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, UK.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Herron', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, UK.'}, {'ForeName': 'Evans', 'Initials': 'E', 'LastName': 'Asamane', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, UK.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Peat', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, UK.'}]",BMJ open,['10.1136/bmjopen-2020-048196'] 2722,33771716,"Evaluation of the pharmacokinetic effects of itraconazole on alflutinib (AST2818): an open-label, single-center, single-sequence, two-period randomized study in healthy volunteers.","Alflutinib (AST2818) is a newly developed third-generation EGFR tyrosine kinase inhibitor for the treatment of lung cancer patients with T790M-resistant mutations. It is metabolized mainly by the CYP3A4 enzyme. At the same time, it has the potential to induce CYP3A4. In this study, we aimed to estimate the effect of itraconazole (a strong inhibitor of CYP3A4) on the pharmacokinetics of alflutinib. For this aim, a single-center, open-label, single-sequence, two-period trial was designed. The pharmacokinetic parameters of AST2818 and its active metabolite AST5902 were established from blood concentration measurements, and adverse events (AEs) of two periods of treatment were documented. For AST2818, the C max , AUC 0-t , and AUC 0-∞ in period II (coadministration of itraconazole) increased by 6.5 ng/mL, 1263.0 h*ng/mL, and 1067.0 h*ng/mL, respectively. And the corresponding 90% CIs were 1.23 (1.14-1.32), 2.41 (2.29-2.54), and 2.22 (2.11-2.34), respectively. The C max , AUC 0-t , and AUC 0-∞ of AST5902 in period II decreased by 4.849 ng/mL, 415.60 h*ng/mL, and 391.4 h*ng/mL, respectively. Moreover, the corresponding 90% CIs were 0.09 (0.08-0.10), 0.18 (0.17-0.19), and 0.14 (0.13-0.15), respectively. Nonetheless, in period II, plasma concentrations of total active components (AST2818 and AST5902) changed marginally. The AUC 0-∞ of total active components increased 60%, and the corresponding C max increased 8%. Possible treatment-related AEs assessed by investigators were fewer in period II (23.3% vs 36.7%). In conclusion, the total exposure of AST2818 and active metabolite AST5902 increased following the coadministration of itraconazole, but it was still safe and well-tolerated.",2021,"Nonetheless, in period II, plasma concentrations of total active components (AST2818 and AST5902) changed marginally.","['healthy volunteers', 'lung cancer patients with T790M-resistant mutations']",['itraconazole'],"['plasma concentrations of total active components (AST2818 and AST5902', 'C max , AUC 0-t , and AUC 0-∞ of AST5902', 'total exposure of AST2818 and active metabolite AST5902', 'still safe and well-tolerated', 'blood concentration measurements, and adverse events (AEs']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}]","[{'cui': 'C0064113', 'cui_str': 'Itraconazole'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0427728', 'cui_str': 'Blood concentration, dipstick - finding'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0628178,"Nonetheless, in period II, plasma concentrations of total active components (AST2818 and AST5902) changed marginally.","[{'ForeName': 'Jianfu', 'Initials': 'J', 'LastName': 'Heng', 'Affiliation': 'Department of Clinical Pharmaceutical Research Institution, Hunan Cancer Hospital, Affiliated Tumor Hospital of Xiangya Medical School of Central South University, Changsha, Hunan, 410013, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Tang', 'Affiliation': 'Department of Clinical Pharmaceutical Research Institution, Hunan Cancer Hospital, Affiliated Tumor Hospital of Xiangya Medical School of Central South University, Changsha, Hunan, 410013, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Early Clinical Trail Center, Hunan Cancer Hospital, Affiliated Tumor Hospital of Xiangya Medical School of Central South University, Changsha, Hunan, 410013, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Bao', 'Affiliation': 'Shanghai Allist Pharmaceuticals Co., Ltd, Shanghai, 201203, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Deng', 'Affiliation': 'Department of Early Clinical Trail Center, Hunan Cancer Hospital, Affiliated Tumor Hospital of Xiangya Medical School of Central South University, Changsha, Hunan, 410013, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Early Clinical Trail Center, Hunan Cancer Hospital, Affiliated Tumor Hospital of Xiangya Medical School of Central South University, Changsha, Hunan, 410013, China.'}, {'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Early Clinical Trail Center, Hunan Cancer Hospital, Affiliated Tumor Hospital of Xiangya Medical School of Central South University, Changsha, Hunan, 410013, China.'}, {'ForeName': 'Songlin', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': 'Department of Clinical Pharmaceutical Research Institution, Hunan Cancer Hospital, Affiliated Tumor Hospital of Xiangya Medical School of Central South University, Changsha, Hunan, 410013, China.'}, {'ForeName': 'Xiaobao', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Clinical Pharmaceutical Research Institution, Hunan Cancer Hospital, Affiliated Tumor Hospital of Xiangya Medical School of Central South University, Changsha, Hunan, 410013, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Department of Clinical Pharmaceutical Research Institution, Hunan Cancer Hospital, Affiliated Tumor Hospital of Xiangya Medical School of Central South University, Changsha, Hunan, 410013, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Clinical Pharmaceutical Research Institution, Hunan Cancer Hospital, Affiliated Tumor Hospital of Xiangya Medical School of Central South University, Changsha, Hunan, 410013, China.'}, {'ForeName': 'Nong', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Department of Lung Cancer and Gastroenterology, Hunan Cancer Hospital, Affiliated Tumor Hospital of Xiangya Medical School of Central South University, Changsha, Hunan, 410013, China.'}, {'ForeName': 'Kunyan', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Department of Clinical Pharmaceutical Research Institution, Hunan Cancer Hospital, Affiliated Tumor Hospital of Xiangya Medical School of Central South University, Changsha, Hunan, 410013, China. Electronic address: likunyan@hnca.org.cn.'}]",European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences,['10.1016/j.ejps.2021.105815'] 2723,33771659,Histological evaluation of extraction sites grafted with Bio-Oss Collagen: Randomized controlled trial.,"The combination of bovine bone matrix with collagen shows good results in bone and volume preservation after tooth extraction. To determine the ideal time to apply an implant after augmentation with Bio-Oss Collagen and to observe if there are differences in the age of the patients and the sex, the aim of this randomized controlled clinical trial was to compare the post-extraction changes in angiogenic and osteogenic aspects during spontaneous bone regeneration with those during socket preservation using Bio-Oss Collagen. Sixty-six patients were included in this study. After 8-12 weeks, bone biopsies were embedded in paraffin and histological and immune-histological investigated. Using qRT-PCR bone (Alpl, Bglap, Runx2) and angiogenic markers (VEGF, caveolin-1) were identified. The histomorphometric analysis of all examined samples showed no differences between treated and untreated sockets, but a tissue compression. After classification in bone regeneration stages, more samples with woven bone were present in treated sockets than in controls. The Alpl expression correlates with increase in mature bone tissue. In treated sockets a significant decrease in CD34 and caveolin-1 protein expression was found. Additionally, a significant increase of Runx2 and VEGF mRNA was detected in patients younger than 50 years. Thus, all specimens showed ossification in different stages after eight weeks of healing. The treated group gives an earlier stage of ossification than controls, but produces densified tissue with greater volume fraction. It can be assumed that successful implant placement in Bio-Oss Collagen augmented extraction sockets is possible after eight weeks of bone healing.",2021,"Using qRT-PCR bone (Alpl, Bglap, Runx2) and angiogenic markers (VEGF, caveolin-1) were identified.","['Sixty-six patients were included in this study', 'patients younger than 50 years']",[],"['CD34 and caveolin-1 protein expression', 'Runx2 and VEGF mRNA']","[{'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0054953', 'cui_str': 'Lymphocyte antigen CD34'}, {'cui': 'C0379710', 'cui_str': 'Caveolin-1'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1529564', 'cui_str': 'RUNX2 protein, human'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}]",66.0,0.0126445,"Using qRT-PCR bone (Alpl, Bglap, Runx2) and angiogenic markers (VEGF, caveolin-1) were identified.","[{'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Keil', 'Affiliation': 'Department of Orthodontics, Technische Universität Dresden, Fetscherstr. 74, 01307 Dresden, Germany. Electronic address: christiane.keil@uniklinikum-dresden.de.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Gollmer', 'Affiliation': 'Department of Orthodontics, Technische Universität Dresden, Fetscherstr. 74, 01307 Dresden, Germany.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Zeidler-Rentzsch', 'Affiliation': 'Department of Orthodontics, Technische Universität Dresden, Fetscherstr. 74, 01307 Dresden, Germany.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Gredes', 'Affiliation': 'Department of Orthodontics, Technische Universität Dresden, Fetscherstr. 74, 01307 Dresden, Germany.'}, {'ForeName': 'Friedhelm', 'Initials': 'F', 'LastName': 'Heinemann', 'Affiliation': 'Department of Prosthodontics, Gerodontology and Biomaterials, University of Greifswald, Rotgerberstr. 8, 17475 Greifswald, Germany.'}]",Annals of anatomy = Anatomischer Anzeiger : official organ of the Anatomische Gesellschaft,['10.1016/j.aanat.2021.151722'] 2724,33773357,Predictors and moderators of symptom change during cognitive-behavioral therapy or supportive psychotherapy for body dysmorphic disorder.,"BACKGROUND Research on predictors of treatment outcome in body dysmorphic disorder, a common and severe disorder, is very limited, and no prior studies have examined moderators of outcome. Because treatment is often but not always efficacious, it is important to identify who is more likely to benefit. We examined predictors and moderators of improvement with therapist-delivered cognitive-behavioral therapy versus supportive psychotherapy in the only study of these treatments for body dysmorphic disorder. This report presents secondary analyses from a study whose primary findings have previously been published (Wilhelm et al., 2019). METHODS Participants (N=120) with DSM-IV body dysmorphic disorder were randomized to therapist-delivered weekly cognitive-behavioral therapy or supportive therapy for 24 weeks. Using reliable and valid measures, we tested baseline body dysmorphic disorder severity, insight/delusionality, and depression severity as predictors and moderators of overall and treatment modality-specific symptom change. We explored additional variables as predictors and moderators of outcome. RESULTS Greater treatment credibility (p=0.02) and presence of obsessive-compulsive personality disorder (p=0.03) predicted greater improvement. Serotonin-reuptake inhibitor treatment at baseline (unchanged during the study) (p=0.01) predicted less improvement. No other variables predicted or moderated outcome (all p>0.05). LIMITATIONS The study was not powered a priori to detect predictor or moderation effects, which limited our ability to detect them unless they were strong. CONCLUSIONS Because greater treatment credibility predicted better outcomes, fostering credibility during therapy may maximize gains. Improvement was not impeded by more severe body dysmorphic disorder, depressive symptoms, or poorer insight. No variables moderated treatment-specific improvement.",2021,"RESULTS Greater treatment credibility (p=0.02) and presence of obsessive-compulsive personality disorder (p=0.03) predicted greater improvement.","['Participants (N=120) with DSM-IV body dysmorphic disorder', 'body dysmorphic disorder']","['therapist-delivered weekly cognitive-behavioral therapy or supportive therapy', 'therapist-delivered cognitive-behavioral therapy versus supportive psychotherapy', 'cognitive-behavioral therapy or supportive psychotherapy']","['baseline body dysmorphic disorder severity, insight/delusionality, and depression severity as predictors and moderators of overall and treatment modality-specific symptom change', 'presence of obsessive-compulsive personality disorder', 'severe body dysmorphic disorder, depressive symptoms, or poorer insight']","[{'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0005887', 'cui_str': 'Body dysmorphic disorder'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0221295', 'cui_str': 'Supportive psychotherapy'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005887', 'cui_str': 'Body dysmorphic disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0233820', 'cui_str': 'Insight'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]",,0.0605692,"RESULTS Greater treatment credibility (p=0.02) and presence of obsessive-compulsive personality disorder (p=0.03) predicted greater improvement.","[{'ForeName': 'Katharine A', 'Initials': 'KA', 'LastName': 'Phillips', 'Affiliation': 'Rhode Island Hospital; Alpert Medical School of Brown University; New York-Presbyterian Hospital; Weill Cornell Medical College, Cornell University. Electronic address: kap9161@med.cornell.edu.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Greenberg', 'Affiliation': 'Massachusetts General Hospital; Harvard Medical School.'}, {'ForeName': 'Susanne S', 'Initials': 'SS', 'LastName': 'Hoeppner', 'Affiliation': 'Massachusetts General Hospital; Harvard Medical School.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Weingarden', 'Affiliation': 'Massachusetts General Hospital; Harvard Medical School.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': ""O'Keefe"", 'Affiliation': 'Massachusetts General Hospital; Harvard Medical School.'}, {'ForeName': 'Aparna', 'Initials': 'A', 'LastName': 'Keshaviah', 'Affiliation': 'Massachusetts General Hospital; Harvard Medical School; Mathematica Policy Research.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Schoenfeld', 'Affiliation': 'Massachusetts General Hospital; Harvard Medical School.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Wilhelm', 'Affiliation': 'Massachusetts General Hospital; Harvard Medical School.'}]",Journal of affective disorders,['10.1016/j.jad.2021.03.011'] 2725,33773200,Sleep and alcohol use among young adult drinkers with Insomnia: A daily process model.,"BACKGROUND Previous studies examining associations between sleep and alcohol use have done so primarily at the aggregate (between-person) level and primarily among healthy young adults. This study aimed to examine reciprocal, within-person associations between sleep and alcohol use among young adult drinkers with insomnia. METHODS Young adults who engaged in past-month binge drinking and met diagnostic criteria for insomnia (N = 56) wore wrist actigraphy and completed online daily diaries assessing sleep and drinking for an average of 8.52 days (SD = 2.31), resulting in 477 reports. Multilevel models were used to examine within- and between-person effects of sleep quality and efficiency on alcohol use and vice versa. Bedtime and waketime were included as secondary sleep parameters. RESULTS Participants reported drinking on 231 days (48%). Participants did not report significantly different sleep quality on heavier-drinking days, nor did they demonstrate significant changes in actigraphy-measured sleep efficiency. However, they self-reported better sleep efficiency on heavier-drinking days (driven primarily by improvements in sleep onset latency), and they reported heavier drinking following days of better sleep efficiency (driven by improvements in total sleep time). Drinking was also associated with later bedtimes and waketimes. CONCLUSIONS Young adult drinkers with insomnia report reciprocal associations between subjective sleep efficiency and alcohol use, but these results were not replicated using objective measures. Providers may need to challenge the belief that there is a positive association between alcohol use and sleep among young adults who drink and have insomnia.",2021,"Participants did not report significantly different sleep quality on heavier-drinking days, nor did they demonstrate significant changes in actigraphy-measured sleep efficiency.","['young adult drinkers with Insomnia', 'young adult drinkers with insomnia', 'young adults who drink and have insomnia', 'healthy young adults', 'Young adults who engaged in past-month binge drinking and met diagnostic criteria for insomnia']",['wrist actigraphy and completed online daily diaries assessing sleep and drinking'],"['sleep quality', 'total sleep time', 'actigraphy-measured sleep efficiency']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",,0.0339851,"Participants did not report significantly different sleep quality on heavier-drinking days, nor did they demonstrate significant changes in actigraphy-measured sleep efficiency.","[{'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Miller', 'Affiliation': 'University of Missouri, 1 Hospital Drive DC067.00, Columbia, MO 65212, USA. Electronic address: millmary@health.missouri.edu.'}, {'ForeName': 'Lindsey K', 'Initials': 'LK', 'LastName': 'Freeman', 'Affiliation': 'University of Missouri, 1 Hospital Drive DC067.00, Columbia, MO 65212, USA.'}, {'ForeName': 'Chelsea B', 'Initials': 'CB', 'LastName': 'Deroche', 'Affiliation': 'University of Missouri, 1 Hospital Drive DC067.00, Columbia, MO 65212, USA.'}, {'ForeName': 'Chan Jeong', 'Initials': 'CJ', 'LastName': 'Park', 'Affiliation': 'University of Missouri, 1 Hospital Drive DC067.00, Columbia, MO 65212, USA.'}, {'ForeName': 'Nicole A', 'Initials': 'NA', 'LastName': 'Hall', 'Affiliation': 'University of Missouri, 1 Hospital Drive DC067.00, Columbia, MO 65212, USA.'}, {'ForeName': 'Christina S', 'Initials': 'CS', 'LastName': 'McCrae', 'Affiliation': 'University of Missouri, 1 Hospital Drive DC067.00, Columbia, MO 65212, USA.'}]",Addictive behaviors,['10.1016/j.addbeh.2021.106911'] 2726,33773189,"Carvacrol improves pulmonary function tests, oxidant/antioxidant parameters and cytokine levels in asthmatic patients: A randomized, double-blind, clinical trial.","BACKGROUND Carvacrol effects on inflammatory mediators, lung pathology and tracheal responsiveness were indicated in animal models of pulmonary diseases. PURPOSE To evaluate carvacrol effects on respiratory symptoms, pulmonary function tests (PFT), oxidative stress markers and cytokine levels in asthmatic patients. STUDY DESIGN This study was a randomized, placebo-controlled double-blind, clinical trial. METHODS Thirty-three moderate asthmatic patients were divided to the two groups of: placebo group (n = 16) and carvacrol group (1.2 mg/kg/day, n = 17). Prepared capsules were taken for two months along, 3 times/day along with routine medications. Respiratory symptoms, PFT, and oxidative stress markers were evaluated before the treatment (step 0), and one (step I) and two months (step II) after the beginning of the treatment. However, cytokine levels in serum and supernatant of peripheral blood mononuclear cells (PBMC), and their gene expression were evaluated in step 0 and II. RESULTS In carvacrol-treated group, respiratory symptoms significantly decreased after one- and two-month treatment with carvacrol compared to pre-treatment values (p < 0.05 to p < 0.001). Compared to step 0, PFT values were significantly increased in step I and II, in treated group with carvacrol (p < 0.05 to p < 0.001). Most oxidative stress markers were improved following carvacrol treatment (p < 0.05 to p < 0.001). Treatment with carvacrol for two-month also significantly improved cytokine levels in serum and supernatant of PBMC, compared to step 0 (p < 0.05 to p < 0.001). However, no significant changes were observed in the above-noted parameters in the placebo group. CONCLUSION Due to anti-inflammatory and antioxidant effect, carvacrol could be suggested as a therapeutic agent for asthma.",2021,Most oxidative stress markers were improved following carvacrol treatment (p < 0.05 to p < 0.001).,"['asthmatic patients', 'Thirty-three moderate asthmatic patients']","['placebo', 'carvacrol', 'Carvacrol']","['respiratory symptoms', 'inflammatory mediators, lung pathology and tracheal responsiveness', 'oxidative stress markers', 'pulmonary function tests, oxidant/antioxidant parameters and cytokine levels', 'Respiratory symptoms, PFT, and oxidative stress markers', 'cytokine levels in serum and supernatant of peripheral blood mononuclear cells (PBMC), and their gene expression', 'cytokine levels in serum and supernatant of PBMC', 'respiratory symptoms, pulmonary function tests (PFT), oxidative stress markers and cytokine levels', 'PFT values']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007309', 'cui_str': 'carvacrol'}]","[{'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C2945595', 'cui_str': 'Tracheal'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0085403', 'cui_str': 'Oxidizing Agents'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",33.0,0.0783933,Most oxidative stress markers were improved following carvacrol treatment (p < 0.05 to p < 0.001).,"[{'ForeName': 'Vahideh', 'Initials': 'V', 'LastName': 'Ghorani', 'Affiliation': 'Applied Biomedical Research Center, Mashhad University of Medical Sciences, Mashhad, Iran; Department of Physiology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Alavinezhad', 'Affiliation': 'Applied Biomedical Research Center, Mashhad University of Medical Sciences, Mashhad, Iran; Department of Physiology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Rajabi', 'Affiliation': 'Department of Drug and Food Control, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Boskabady', 'Affiliation': 'Applied Biomedical Research Center, Mashhad University of Medical Sciences, Mashhad, Iran; Department of Physiology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: boskabadymh@mums.ac.ir.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2021.153539'] 2727,33773170,Adjuvant concomitant treatment with traditional Chinese medicines in patients receiving chemotherapy for HER2-Positive breast cancer: A pilot randomized controlled trial.,"This study aimed to evaluate the impact of Chinese medicine on controlling cancer and easing adverse events in patients with HER2-positive breast cancer. We recruited consecutive HER2-positive breast cancer patients who underwent radical mastectomy from January 2015 to January 2019. Patients were randomly assigned to receive chemotherapy plus Chinese medicine or chemotherapy alone. The left ventricular global longitudinal strain was better in the experimental group (P < 0.01). The reduction in white blood cells was more significant in the control group (P < 0.01). Hepatic function in the experimental group was better than that in control group after chemotherapy (P < 0.01). In addition, the scores of symptom dimensions for pain, diarrhea, and hair loss were better in the experimental group than in the control group after chemotherapy (P < 0.01). For patients with HER2-positive breast cancer, personalization of traditional Chinese medicine can not only enhance the anti-cancer function of chemotherapy but also ease serious adverse effects.",2021,The left ventricular global longitudinal strain was better in the experimental group (P < 0.01).,"['consecutive HER2-positive breast cancer patients who underwent radical mastectomy from January 2015 to January 2019', 'patients with HER2-positive breast cancer', 'patients receiving chemotherapy for HER2-Positive breast cancer']","['chemotherapy plus Chinese medicine or chemotherapy alone', 'traditional Chinese medicines', 'Chinese medicine']","['left ventricular global longitudinal strain', 'reduction in white blood cells', 'Hepatic function', 'scores of symptom dimensions for pain, diarrhea, and hair loss']","[{'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024884', 'cui_str': 'Radical mastectomy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}]",,0.0887945,The left ventricular global longitudinal strain was better in the experimental group (P < 0.01).,"[{'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'Department of Traditional Chinese Medicine, the First Affiliated Hospital of Anhui Medical University, 218 Jixi Rd, Hefei, 230022, Anhui, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Tumor Department of Anhui Provincial Hospital 17 Lu Jiang Rd, Hefei, 230001, Anhui, China; Provincial Hospital Affiliated to Anhui Medical University, Hefei, 230001, Anhui, China.'}, {'ForeName': 'Hua-Cheng', 'Initials': 'HC', 'LastName': 'Wang', 'Affiliation': 'Department of Traditional Chinese Medicine, the First Affiliated Hospital of Anhui Medical University, 218 Jixi Rd, Hefei, 230022, Anhui, China. Electronic address: wangchenghua20047@163.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101373'] 2728,33811444,"A Phase II study of autologous mesenchymal stromal cells and c-kit positive cardiac cells, alone or in combination, in patients with ischaemic heart failure: the CCTRN CONCERT-HF trial.","AIMS CONCERT-HF is an NHLBI-sponsored, double-blind, placebo-controlled, Phase II trial designed to determine whether treatment with autologous bone marrow-derived mesenchymal stromal cells (MSCs) and c-kit positive cardiac cells (CPCs), given alone or in combination, is feasible, safe, and beneficial in patients with heart failure (HF) caused by ischaemic cardiomyopathy. METHODS AND RESULTS Patients were randomized (1:1:1:1) to transendocardial injection of MSCs combined with CPCs, MSCs alone, CPCs alone, or placebo, and followed for 12 months. Seven centres enrolled 125 participants with left ventricular ejection fraction of 28.6 ± 6.1% and scar size 19.4 ± 5.8%, in New York Heart Association class II or III. The proportion of major adverse cardiac events (MACE) was significantly decreased by CPCs alone (-22% vs. placebo, P = 0.043). Quality of life (Minnesota Living with Heart Failure Questionnaire score) was significantly improved by MSCs alone (P = 0.050) and MSCs + CPCs (P = 0.023) vs. placebo. Left ventricular ejection fraction, left ventricular volumes, scar size, 6-min walking distance, and peak oxygen consumption did not differ significantly among groups. CONCLUSIONS This is the first multicentre trial assessing CPCs and a combination of two cell types from different tissues in HF patients. The results show that treatment is safe and feasible. Even with maximal guideline-directed therapy, both CPCs and MSCs were associated with improved clinical outcomes (MACE and quality of life, respectively) in ischaemic HF without affecting left ventricular function or structure, suggesting possible systemic or paracrine cellular mechanisms. Combining MSCs with CPCs was associated with improvement in both these outcomes. These results suggest potential important beneficial effects of CPCs and MSCs and support further investigation in HF patients.",2021,Quality of life (MLHFQ score) was significantly improved by MSCs alone (P = 0.050) and MSCs+CPCs (P = 0.023) vs. placebo.,"['Patients', 'Patients with Ischemic Heart Failure', 'Seven centers enrolled 125 participants with left ventricular ejection fraction (LVEF) of 28.6\u2009±\u20096.1% and scar size 19.4\u2009±\u20095.8%, in NYHA class II or III', 'HF patients', 'patients with heart failure (HF) caused by ischemic cardiomyopathy']","['autologous bone marrow-derived mesenchymal stromal cells (MSCs) and c-kit positive cardiac cells (CPCs', 'placebo', 'transendocardial injection of MSCs combined with CPCs, MSCs alone, CPCs alone, or placebo', 'Autologous Mesenchymal Stromal Cells and c-kit Positive Cardiac Cells, Alone or in Combination']","['proportion of major adverse cardiac events (MACE', 'LVEF, LV volumes, scar size, 6-min walking distance, and peak VO 2', 'Quality of life (MLHFQ score', 'clinical outcomes (MACE and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C4517679', 'cui_str': '28.6'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C4709305', 'cui_str': '19.4'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0349782', 'cui_str': 'Generalized ischemic myocardial dysfunction'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C3178844', 'cui_str': 'Mesenchymal Stromal Cells'}, {'cui': 'C0072470', 'cui_str': 'Lymphocyte antigen CD117'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",125.0,0.185245,Quality of life (MLHFQ score) was significantly improved by MSCs alone (P = 0.050) and MSCs+CPCs (P = 0.023) vs. placebo.,"[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Bolli', 'Affiliation': 'University of Louisville, School of Medicine, Louisville, KY, USA.'}, {'ForeName': 'Raul D', 'Initials': 'RD', 'LastName': 'Mitrani', 'Affiliation': 'University of Miami, Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Hare', 'Affiliation': 'University of Miami, Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Pepine', 'Affiliation': 'University of Florida College of Medicine, Gainesville, FL, USA.'}, {'ForeName': 'Emerson C', 'Initials': 'EC', 'LastName': 'Perin', 'Affiliation': ""Texas Heart Institute, CHI St. Luke's Health Baylor College of Medicine Medical Center, Houston, TX, USA.""}, {'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'Willerson', 'Affiliation': ""Texas Heart Institute, CHI St. Luke's Health Baylor College of Medicine Medical Center, Houston, TX, USA.""}, {'ForeName': 'Jay H', 'Initials': 'JH', 'LastName': 'Traverse', 'Affiliation': 'Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, and University of Minnesota School of Medicine, Minneapolis, MN, USA.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Henry', 'Affiliation': 'The Carl and Edyth Lindner Center for Research and Education, The Christ Hospital, Cincinnati, OH, USA.'}, {'ForeName': 'Phillip C', 'Initials': 'PC', 'LastName': 'Yang', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Murphy', 'Affiliation': 'Johns Hopkins University, Cardiovascular Imaging, Baltimore, MD, USA.'}, {'ForeName': 'Keith L', 'Initials': 'KL', 'LastName': 'March', 'Affiliation': 'University of Florida College of Medicine, Gainesville, FL, USA.'}, {'ForeName': 'Ivonne H', 'Initials': 'IH', 'LastName': 'Schulman', 'Affiliation': 'University of Miami, Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Sohail', 'Initials': 'S', 'LastName': 'Ikram', 'Affiliation': 'University of Louisville, School of Medicine, Louisville, KY, USA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Lee', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': ""O'Brien"", 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Joao A', 'Initials': 'JA', 'LastName': 'Lima', 'Affiliation': 'Johns Hopkins University, Cardiovascular Imaging, Baltimore, MD, USA.'}, {'ForeName': 'Mohammad R', 'Initials': 'MR', 'LastName': 'Ostovaneh', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Bharath', 'Initials': 'B', 'LastName': 'Ambale-Venkatesh', 'Affiliation': 'Johns Hopkins University, Cardiovascular Imaging, Baltimore, MD, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Lewis', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Aisha', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'University of Miami, Miller School of Medicine, Interdisciplinary Stem Cell Institute, Miami, FL, USA.'}, {'ForeName': 'Ketty', 'Initials': 'K', 'LastName': 'Bacallao', 'Affiliation': 'University of Miami, Miller School of Medicine, Interdisciplinary Stem Cell Institute, Miami, FL, USA.'}, {'ForeName': 'Krystalenia', 'Initials': 'K', 'LastName': 'Valasaki', 'Affiliation': 'University of Miami, Miller School of Medicine, Interdisciplinary Stem Cell Institute, Miami, FL, USA.'}, {'ForeName': 'Bangon', 'Initials': 'B', 'LastName': 'Longsomboon', 'Affiliation': 'University of Miami, Miller School of Medicine, Interdisciplinary Stem Cell Institute, Miami, FL, USA.'}, {'ForeName': 'Adrian P', 'Initials': 'AP', 'LastName': 'Gee', 'Affiliation': 'Center for Cell and Gene Therapy, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Richman', 'Affiliation': 'Center for Cell and Gene Therapy, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Doris A', 'Initials': 'DA', 'LastName': 'Taylor', 'Affiliation': ""Texas Heart Institute, CHI St. Luke's Health Baylor College of Medicine Medical Center, Houston, TX, USA.""}, {'ForeName': 'Dejian', 'Initials': 'D', 'LastName': 'Lai', 'Affiliation': 'UTHealth University of Texas Health Science Center at Houston School of Public Health, Houston, TX, USA.'}, {'ForeName': 'Shelly L', 'Initials': 'SL', 'LastName': 'Sayre', 'Affiliation': 'UTHealth University of Texas Health Science Center at Houston School of Public Health, Houston, TX, USA.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Bettencourt', 'Affiliation': 'UTHealth University of Texas Health Science Center at Houston School of Public Health, Houston, TX, USA.'}, {'ForeName': 'Rachel W', 'Initials': 'RW', 'LastName': 'Vojvodic', 'Affiliation': 'UTHealth University of Texas Health Science Center at Houston School of Public Health, Houston, TX, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Cohen', 'Affiliation': 'UTHealth University of Texas Health Science Center at Houston School of Public Health, Houston, TX, USA.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Simpson', 'Affiliation': 'UTHealth University of Texas Health Science Center at Houston School of Public Health, Houston, TX, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Aguilar', 'Affiliation': 'UTHealth University of Texas Health Science Center at Houston School of Public Health, Houston, TX, USA.'}, {'ForeName': 'Catalin', 'Initials': 'C', 'LastName': 'Loghin', 'Affiliation': 'UTHealth University of Texas Health Science Center at Houston McGovern Medical School, Houston, TX, USA.'}, {'ForeName': 'Lem', 'Initials': 'L', 'LastName': 'Moyé', 'Affiliation': 'UTHealth University of Texas Health Science Center at Houston School of Public Health, Houston, TX, USA.'}, {'ForeName': 'Ray F', 'Initials': 'RF', 'LastName': 'Ebert', 'Affiliation': 'NIH, National Heart, Lung and Blood Institute, Bethesda, MD, USA.'}, {'ForeName': 'Barry R', 'Initials': 'BR', 'LastName': 'Davis', 'Affiliation': 'UTHealth University of Texas Health Science Center at Houston School of Public Health, Houston, TX, USA.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Simari', 'Affiliation': 'University of Kansas, School of Medicine, Kansas City, KS, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of heart failure,['10.1002/ejhf.2178'] 2729,33810904,Immunogenicity and safety of sabin-strain based inactivated poliovirus vaccine replacing salk-strain based inactivated poliovirus vaccine: An innovative application of different strain-IPVs replacement.,"BACKGROUND A domestic Sabin strain-based inactivated poliovirus vaccine (Sabin IPV) was approved by China Food and Drug Administration in 2017 as a replacement for the Salk strain-based inactivated poliovirus vaccine (Salk IPV) that has been in use in China for over 10 years. The present post-marketing trial was implemented in China to assess the immunogenicity and safety of replacing the Salk IPV with the Sabin IPV in the last two immunizations of the standard three-dose schedule. METHODS We conducted a randomized, controlled clinical trial with two groups that received three doses of IPVs at the age of 2, 3, and 4 months: the Salk-Sabin-Sabin group and the Salk-Salk-Salk group. Blood samples were collected before vaccination and 30-40 days after the third dose of vaccination. The seroconversion rates and antibody geometric mean titers (GMTs) were calculated and analyzed to evaluate immunogenicity. The safety of both immunization schedules was also monitored and analyzed. RESULTS Of 360 recruited healthy infants, all three IPV doses were administered and blood collection was completed in 330 infants. All participants (100%) in both groups were seropositive for all three poliovirus types after the last vaccination. There were significant differences between the two groups (P < 0.001) in the GMTs for antibodies against poliovirus types 1 and 2, but no significant difference was observed for antibodies against type 3 (P = 0.009). A non-inferiority t-test showed that the post-immunization GMTs for all three types in the Salk-Sabin-Sabin group were not inferior to those in the Salk-Salk-Salk group (P < 0.001). Safety assessment indicated that there was no significant difference in the incidence of all adverse events between the two groups (P = 0.806). CONCLUSIONS The Salk-Sabin-Sabin IPV immunization schedule is not inferior to the Salk-Salk-Salk IPV schedule in terms of both immunogenicity and safety. Clinical trial number: NCT04051736.",2021,"There were significant differences between the two groups (P < 0.001) in the GMTs for antibodies against poliovirus types 1 and 2, but no significant difference was observed for antibodies against type 3 (P = 0.009).",['360 recruited healthy infants'],"['Salk-Sabin-Sabin group and the Salk-Salk-Salk group', 'sabin-strain based inactivated poliovirus vaccine replacing salk-strain based inactivated poliovirus vaccine', 'domestic Sabin strain-based inactivated poliovirus vaccine (Sabin IPV']","['seroconversion rates and antibody geometric mean titers (GMTs', 'Blood samples', 'Immunogenicity and safety', 'incidence of all adverse events']","[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036106', 'cui_str': 'Salk Vaccine'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0003063', 'cui_str': 'Domestic Animals'}]","[{'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",360.0,0.155328,"There were significant differences between the two groups (P < 0.001) in the GMTs for antibodies against poliovirus types 1 and 2, but no significant difference was observed for antibodies against type 3 (P = 0.009).","[{'ForeName': 'Haiping', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'China National Biotec Group Company Limited, Beijing, China.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Gao', 'Affiliation': 'Tianjin Centers for Disease Control and Prevention, Tianjin, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Bai', 'Affiliation': 'Beijing Center for Diseases and Prevention Control, Beijing, China.'}, {'ForeName': 'Xiaoqin', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'China National Biotec Group Company Limited, Beijing, China.'}, {'ForeName': 'Shasha', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': 'China National Biotec Group Company Limited, Beijing, China.'}, {'ForeName': 'Yanhui', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': 'China National Biotec Group Company Limited, Beijing, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Beijing Chaoyang District Center for Diseases and Prevention Control, Beijing, China.'}, {'ForeName': 'Yinghong', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Tianjin Jinghai District Center for Disease Control and Prevention, Tianjin, China.'}, {'ForeName': 'Hongmei', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Tianjin Jinghai District Center for Disease Control and Prevention, Tianjin, China.'}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'China National Biotec Group Company Limited, Beijing, China. Electronic address: yangxiaoming@sinopharm.com.'}]",Vaccine,['10.1016/j.vaccine.2021.02.073'] 2730,33812327,The effect of oral magnesium supplementation on acute non-specific low back pain: Prospective randomized clinical trial.,"OBJECTIVE We aimed to investigate the effect of oral magnesium supplementation for acute low back pain. METHODS This is a three-arm, prospective randomized open label clinical trial, which included two hundred and forty patients. We based our sample size calculation assumptions on a recently published clinical trial, thus we enrolled 80 patients for each group. NSAID alone group included (400 mg etodolac twice a day), NSAID + mg group included NSAID - magnesium combination treatment (400 mg etodolac twice a day with 365 mg oral magnesium supplementation) and NSAID + paracetamol group included NSAID - paracetamol combination treatment (400 mg etodolac twice a day with 500 mg paracetamol twice a day). Follow-up visits after initiation of relevant treatment were performed at 4th and 10th days and outcome measures included pain (Visual analogue scale - VAS), mobility of lumbar spine and functional outcome (RMDQ). RESULTS Thirty-one patients were considered lost to follow-up or excluded due to use of other medications and final analysis was performed with 209 participants in three groups (71 patients in NSAID alone group, 68 patients in NSAID + mg group and 70 patients in NSAID + paracetamol group). NSAID + mg showed a significantly higher improvement in RMDQ and VAS scores at acute stage (at 4th day visit) compared to two other study groups However, there was no significant difference between three groups in terms of mean improvement of RMDQ, VAS scores and lumbar mobility between initial visit and 10-day. CONCLUSION Results of this study suggest that addition of magnesium to acute low-back pain treatment does not significantly improve final clinical outcomes. LEVEL OF EVIDENCE Level I, prospective randomized controlled study.",2021,NSAID + mg showed a significantly higher improvement in RMDQ and VAS scores at acute stage (at 4th day visit) compared to two other study groups,"['enrolled 80 patients for each group', 'Thirty-one patients were considered lost to follow-up or excluded due to use of other medications and final analysis was performed with 209 participants in three groups (71 patients in NSAID alone group, 68 patients in', 'acute non-specific low back pain', 'two hundred and forty patients']","['oral magnesium supplementation', 'NSAID + mg group included NSAID - magnesium combination treatment', 'NSAID', 'NSAID + mg group and 70 patients in NSAID + paracetamol', 'magnesium', 'NSAID + paracetamol group included NSAID - paracetamol combination treatment']","['RMDQ and VAS scores', 'mean improvement of RMDQ, VAS scores and lumbar mobility', 'pain (Visual analogue scale - VAS), mobility of lumbar spine and functional outcome (RMDQ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C4319600', 'cui_str': '240'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1096534', 'cui_str': 'Magnesium supplement therapy'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",80.0,0.0747373,NSAID + mg showed a significantly higher improvement in RMDQ and VAS scores at acute stage (at 4th day visit) compared to two other study groups,"[{'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Bayram', 'Affiliation': 'Department of Orthopedics and Traumatology, Istanbul University, Istanbul Faculty of Medicine, Istanbul, Turkey. Electronic address: dr.serkanbayram89@gmail.com.'}, {'ForeName': 'Koray', 'Initials': 'K', 'LastName': 'Şahin', 'Affiliation': 'Department of Orthopedics and Traumatology, Istanbul University, Istanbul Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Fikret Berkan', 'Initials': 'FB', 'LastName': 'Anarat', 'Affiliation': 'Department of Orthopedics and Traumatology, Istanbul University, Istanbul Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Chasan Memet', 'Initials': 'CM', 'LastName': 'Chousein', 'Affiliation': 'Department of Orthopedics and Traumatology, Istanbul University, Istanbul Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Kocazeybek', 'Affiliation': 'Department of Orthopedics and Traumatology, Istanbul University, Istanbul Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Altan', 'Affiliation': 'Department of Orthopedics and Traumatology, Istanbul University, Istanbul Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Turgut', 'Initials': 'T', 'LastName': 'Akgül', 'Affiliation': 'Department of Orthopedics and Traumatology, Istanbul University, Istanbul Faculty of Medicine, Istanbul, Turkey.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2021.03.078'] 2731,33812296,Effects of family participatory dignity therapy on the psychological well-being and family function of patients with haematologic malignancies and their family caregivers: A randomised controlled trial.,"BACKGROUND Strong family ties appear to buffer patient's and family members' difficult experiences during life and health crises. The family participatory dignity therapy programme, a patient-family-centred psychological intervention, was developed based on dignity therapy and performed by one therapist in the form of interview according to a specific question prompt. OBJECTIVES This study aimed to confirm the efficacy of the family participatory dignity therapy programme in improving the psychological well-being and family cohesion and adaptability of patients with haematologic malignancies and their family caregivers. DESIGN A single-blinded, two-arm parallel group, randomised controlled trial was conducted. SETTING(S) and Participants: Participants were patient-family caregiver dyads recruited from Fujian Medical University Union Hospital from March to September 2019. METHODS A total of 68 eligible dyads agreed to participate and were randomly assigned to the intervention group (n = 33) or control group receiving usual care (n = 35). Each pair of patient-family dyads in the intervention group received two or three interviews (each interview approximately lasting 45 to 60 min) performed by one therapist according to a specific question prompt containing 10 questions for patients and 10 corresponding questions for their family caregivers. To evaluate the effects of the intervention, we assessed patients' hope, spiritual well-being, and family cohesion and adaptability, as well as their family caregivers' depression, anxiety, and family cohesion and adaptability at baseline (T0), 1 week (T1), 4 weeks (T2), and 8 weeks post-intervention (T3) and compared the scores between the groups. A two-way repeated-measures analysis of variance was conducted to examine the effects of time, group, and their interaction. RESULTS For patients, there was a significant difference in hope (p = 0.001), spiritual well-being (p = 0.002), and family cohesion (p<0.001) and adaptability (p<0.001) between the intervention and control groups. The difference over time was also significant in family cohesion (p = 0.018) and adaptability (p = 0.003). The interaction effects were significant for hope (p = 0.034), spiritual well-being (p<0.001), and family cohesion (p<0.001) and adaptability (p<0.001). For family caregivers, there was a significant difference in anxiety (p = 0.037), depression (p = 0.001), and family adaptability (p = 0.036) between the intervention and control groups. Within groups, a significant difference in family adaptability (p = 0.012) was found. Moreover, the interaction effects were significant on anxiety (p = 0.001) and family cohesion (p = 0.038). CONCLUSIONS The family participatory dignity therapy programme showed a positive effect on promoting patients' hope, spiritual well-being, and family cohesion and adaptability; amongst family caregivers, it decreased anxiety and depression, and enhanced family cohesion and adaptability. Registration number: ChiCTR1900021433 Tweetable abstract: The family participatory dignity therapy programme promoted patients' hope, spiritual well-being, and family cohesion and adaptability, decreased their family caregivers' anxiety and depression, and enhanced the caregivers' family cohesion and adaptability.",2021,"For patients, there was a significant difference in hope (p = 0.001), spiritual well-being (","['68 eligible dyads agreed to participate', 'patients with haematologic malignancies and their family caregivers', 'Registration number', '\n\n\nand Participants', 'Participants were patient-family caregiver dyads recruited from Fujian Medical University Union Hospital from March to September 2019']","['control group receiving usual care', 'family participatory dignity therapy', 'three interviews (each interview approximately lasting 45 to 60\xa0min) performed by one therapist according to a specific question prompt containing 10 questions for patients and 10 corresponding questions for their family caregivers', 'family participatory dignity therapy programme']","['depression', 'spiritual well-being ', 'anxiety', 'family adaptability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C4704841', 'cui_str': 'Dignity'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015576', 'cui_str': 'Family'}]",68.0,0.0891815,"For patients, there was a significant difference in hope (p = 0.001), spiritual well-being (","[{'ForeName': 'Chunfeng', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Fujian Medical University, No.1 of Xueyuan Road, Shangjie Town, Minhou County, Fuzhou City, Fujian Province, China.'}, {'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, Fujian Medical University, No.1 of Xueyuan Road, Shangjie Town, Minhou County, Fuzhou City, Fujian Province, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Fujian Medical University, No.1 of Xueyuan Road, Shangjie Town, Minhou County, Fuzhou City, Fujian Province, China.'}, {'ForeName': 'Wenkui', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'School of Nursing, Fujian Medical University, No.1 of Xueyuan Road, Shangjie Town, Minhou County, Fuzhou City, Fujian Province, China.'}, {'ForeName': 'Mengting', 'Initials': 'M', 'LastName': 'Xie', 'Affiliation': 'School of Nursing, Fujian Medical University, No.1 of Xueyuan Road, Shangjie Town, Minhou County, Fuzhou City, Fujian Province, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of haematology, Fujian Medical University Union Hospital, No.1 of Xueyuan Road, Shangjie Town, Minhou County, Fuzhou City, Fujian Province, China. Electronic address: wuyong9195@126.com.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Hu', 'Affiliation': 'School of Nursing, Fujian Medical University, No.1 of Xueyuan Road, Shangjie Town, Minhou County, Fuzhou City, Fujian Province, China. Electronic address: ronghu1246@fjmu.edu.cn.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2021.103922'] 2732,33812218,"The effect of berberine adjunctive treatment on glycolipid metabolism in patients with schizophrenia: A randomized, double-blind, placebo-controlled clinical trial.","Previous studies have shown that berberine can improve metabolic disturbances in non-psychiatric patients, but no clinical research has been conducted in schizophrenia. This study was a randomized, double-blind, placebo-controlled clinical trial. Eligible patients diagnosed with schizophrenia were randomized to receive placebo or berberine (900mg/day) as an adjunctive treatment for eight weeks. Peripheral glycolipid metabolism parameters were measured at baseline, week 4, and week 8. Sixty-five patients were included, and forty-nine patients completed the 8-week trial. Berberine led to significant declines in total cholesterol, low-density lipoprotein cholesterol, fasting serum insulin, and insulin resistance(all p<0.05) compared with placebo. Baseline body mass index and serum prolactin concentration could predict the effect of berberine on insulin resistance. Berberine adjunctive treatment may reduce the risk of glycolipid metabolic disturbances in patients with schizophrenia.",2021,"Berberine led to significant declines in total cholesterol, low-density lipoprotein cholesterol, fasting serum insulin, and insulin resistance(all p<0.05) compared with placebo.","['Eligible patients diagnosed with schizophrenia', 'patients with schizophrenia', 'non-psychiatric patients', 'Sixty-five patients were included, and forty-nine patients completed the 8-week trial']","['Berberine adjunctive treatment', 'placebo', 'berberine adjunctive treatment', 'placebo or berberine']","['metabolic disturbances', 'Peripheral glycolipid metabolism parameters', 'total cholesterol, low-density lipoprotein cholesterol, fasting serum insulin, and insulin resistance(all p<0.05', 'glycolipid metabolic disturbances', 'glycolipid metabolism']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0748064', 'cui_str': 'Psychiatric in-patient'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0005117', 'cui_str': 'Berberine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0017950', 'cui_str': 'Glycolipid'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]",65.0,0.538599,"Berberine led to significant declines in total cholesterol, low-density lipoprotein cholesterol, fasting serum insulin, and insulin resistance(all p<0.05) compared with placebo.","[{'ForeName': 'Meijuan', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Laboratory of Biological Psychiatry, Institute of Mental Health, Tianjin Mental Health Center, Tianjin Anding Hospital,Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Laboratory of Biological Psychiatry, Institute of Mental Health, Tianjin Mental Health Center, Tianjin Anding Hospital,Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Yuying', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': 'Laboratory of Biological Psychiatry, Institute of Mental Health, Tianjin Mental Health Center, Tianjin Anding Hospital,Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Institute of Mental Health, Suzhou Psychiatric Hospital, The Affiliated Guangji Hospital of Soochow University, Suzhou, Jiangsu, China.'}, {'ForeName': 'Yonghui', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Laboratory of Biological Psychiatry, Institute of Mental Health, Tianjin Mental Health Center, Tianjin Anding Hospital,Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Yongping', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Laboratory of Biological Psychiatry, Institute of Mental Health, Tianjin Mental Health Center, Tianjin Anding Hospital,Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Jia', 'Affiliation': 'Laboratory of Biological Psychiatry, Institute of Mental Health, Tianjin Mental Health Center, Tianjin Anding Hospital,Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Laboratory of Biological Psychiatry, Institute of Mental Health, Tianjin Mental Health Center, Tianjin Anding Hospital,Tianjin Medical University, Tianjin, China. Electronic address: jieli@tjmhc.com.'}]",Psychiatry research,['10.1016/j.psychres.2021.113899'] 2733,33812203,Transcranial Electrical Stimulation targeting limbic cortex increases the duration of human deep sleep.,"BACKGROUND Researchers have proposed that impaired sleep may be a causal link in the progression from Mild Cognitive Impairment (MCI) to Alzheimer's Disease (AD). Several recent findings suggest that enhancing deep sleep (N3) may improve neurological health in persons with MCI, and buffer the risk for AD. Specifically, Transcranial Electrical Stimulation (TES) of frontal brain areas, the inferred source of the Slow Oscillations (SOs) of N3 sleep, can extend N3 sleep duration and improve declarative memory for recently learned information. Recent work in our laboratory using dense array Electroencephalography (dEEG) localized the sources of SOs to anterior limbic sites - suggesting that targeting these sites with TES may be more effective for enhancing N3. METHODS For the present study, we recruited 13 healthy adults (M = 42 years) to participate in three all-night sleep EEG recordings where they received low level (0.5 mA) TES designed to target anterior limbic areas and a sham stimulation (placebo). We used a convolutional neural network, trained and tested on professionally scored EEG sleep staging, to predict sleep stages for each recording. RESULTS When compared to the sham session, limbic-targeted TES significantly increased the duration of N3 sleep. TES also significantly increased spectral power in the 0.5-1 Hz frequency band (relative to pre-TES epochs) in left temporoparietal and left occipital scalp regions compared to sham. CONCLUSION These results suggest that even low-level TES, when specifically targeting anterior limbic sites, can increase deep (N3) sleep and thereby contribute to healthy sleep quality.",2021,"TES also significantly increased spectral power in the 0.5-1 Hz frequency band (relative to pre-TES epochs) in left temporoparietal and left occipital scalp regions compared to sham. ",['13 healthy adults (M\xa0=\xa042 years) to participate in three all-night sleep EEG recordings where they received low level (0.5\xa0mA'],"['TES', 'sham stimulation (placebo', 'Transcranial Electrical Stimulation targeting limbic cortex', 'Transcranial Electrical Stimulation (TES']","['neurological health', 'duration of N3 sleep', 'spectral power', 'duration of human deep sleep', 'deep (N3) sleep']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0200101', 'cui_str': 'Sleep electroencephalogram'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0455803', 'cui_str': 'Transcranial electrical stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0458337', 'cui_str': 'Limbic lobe'}]","[{'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0234451', 'cui_str': 'Non-rapid eye movement sleep'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]",13.0,0.0564699,"TES also significantly increased spectral power in the 0.5-1 Hz frequency band (relative to pre-TES epochs) in left temporoparietal and left occipital scalp regions compared to sham. ","[{'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Hathaway', 'Affiliation': 'Brain Electrophysiology Laboratory, Co., Eugene, OR, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Morgan', 'Affiliation': 'Brain Electrophysiology Laboratory, Co., Eugene, OR, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Carson', 'Affiliation': 'Brain Electrophysiology Laboratory, Co., Eugene, OR, USA.'}, {'ForeName': 'Roma', 'Initials': 'R', 'LastName': 'Shusterman', 'Affiliation': 'Brain Electrophysiology Laboratory, Co., Eugene, OR, USA.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Fernandez-Corazza', 'Affiliation': 'LEICI Instituto de Investigaciones en Electrónica, Control y Procesamiento de Señales, Universidad Nacional de La Plata, CONICET, Argentina.'}, {'ForeName': 'Phan', 'Initials': 'P', 'LastName': 'Luu', 'Affiliation': 'Brain Electrophysiology Laboratory, Co., Eugene, OR, USA.'}, {'ForeName': 'Don M', 'Initials': 'DM', 'LastName': 'Tucker', 'Affiliation': 'Brain Electrophysiology Laboratory, Co., Eugene, OR, USA; University of Oregon Department of Psychology, Eugene, OR, USA. Electronic address: don.tucker@bel.company.'}]",Sleep medicine,['10.1016/j.sleep.2021.03.001'] 2734,33812168,Omega-3 fatty acids ameliorate vascular inflammation: A rationale for their atheroprotective effects.,"BACKGROUND AND AIMS Clinical trials have demonstrated reductions in major adverse cardiovascular events with purified high-dose eicosapentaenoic acid (EPA), independent of effects on lipids. We aimed to investigate whether omega-3 fatty acids reduce vascular inflammation, a critical mediator of atherosclerosis, and hypothesised that EPA is superior to docosahexaenoic acid (DHA). METHODS In a double-blind randomised controlled trial and cell-culture study, 40 healthy volunteers were supplemented with 4 g daily of either EPA, DHA, fish oil (2:1 EPA:DHA), or placebo for 30 days. Serum was incubated with TNF-stimulated human umbilical vein endothelial cells (HUVECs), and markers of acute vascular inflammation (AVI) were measured. The effects of EPA, DHA (600 mg/kg/day), olive oil, or no treatment were also measured in preclinical models of [1] AVI using a periarterial collar (C57Bl/6J; n = 40 mice) and [2] atherosclerosis where ApoE -/- mice (n = 40) were fed a 16-week atherogenic diet. RESULTS EPA supplementation reduced expression of C-C motif chemokine ligand 2 (CCL2) by 25% compared to placebo (p = 0.03). In the AVI model, EPA reduced vascular expression of VCAM1 by 43% (p = 0.02) and CCL2 by 41% (p = 0.03). Significant inverse correlations were observed between EPA levels and vascular expression of VCAM1 (r = -0.56, p = 0.001) and CCL2 (r = -0.56, p = 0.001). In ApoE -/- mice, EPA reduced aortic expression of Il1b by 44% (p = 0.04) and Tnf by 49% (p = 0.04), with similar inverse correlations between EPA levels and both Il1b (r = -0.63, p = 0.009) and Tnf (r = -0.50, p = 0.04). CONCLUSIONS Supplementation with EPA, more so than DHA, ameliorates acute and chronic vascular inflammation, providing a rationale for the cardiovascular benefit observed with high dose omega-3 fatty acid administration.",2021,"In the AVI model, EPA reduced vascular expression of VCAM1 by 43% (p = 0.02) and CCL2 by 41% (p = 0.03).","['40 healthy volunteers', 'periarterial collar (C57Bl/6J; n\xa0=\xa040 mice) and [2] atherosclerosis where ApoE -/- mice (n\xa0=\xa040) were fed a 16-week']","['olive oil, or no treatment', 'EPA, DHA', 'atherogenic diet', 'omega-3 fatty acids', 'eicosapentaenoic acid (EPA', 'EPA, DHA, fish oil (2:1 EPA:DHA), or placebo', 'placebo', 'CCL2', 'Omega-3 fatty acids']","['umbilical vein endothelial cells (HUVECs), and markers of acute vascular inflammation (AVI', 'aortic expression', 'vascular expression of VCAM1', 'EPA levels and vascular expression of VCAM1', 'expression of C-C motif chemokine ligand 2 (CCL2']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0175751', 'cui_str': 'Cervical collar'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0003595', 'cui_str': 'Apolipoprotein E'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0012161', 'cui_str': 'Diet, Atherogenic'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}]","[{'cui': 'C0041637', 'cui_str': 'Structure of umbilical vein'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C3179121', 'cui_str': 'Endothelial Cells, Human Umbilical Vein'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}]",40.0,0.506158,"In the AVI model, EPA reduced vascular expression of VCAM1 by 43% (p = 0.02) and CCL2 by 41% (p = 0.03).","[{'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'Pisaniello', 'Affiliation': 'Discipline of Medicine, University of Adelaide, Adelaide, Australia; South Australian Health and Medical Research Institute, Adelaide, Australia; School of Medicine, Johns Hopkins University, Baltimore, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Psaltis', 'Affiliation': 'Discipline of Medicine, University of Adelaide, Adelaide, Australia; South Australian Health and Medical Research Institute, Adelaide, Australia.'}, {'ForeName': 'Peta M', 'Initials': 'PM', 'LastName': 'King', 'Affiliation': 'Discipline of Medicine, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Ge', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'School of Agriculture, Food and Wine, FOODPlus Research Centre, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Gibson', 'Affiliation': 'School of Agriculture, Food and Wine, FOODPlus Research Centre, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Joanne Tm', 'Initials': 'JT', 'LastName': 'Tan', 'Affiliation': 'Discipline of Medicine, University of Adelaide, Adelaide, Australia; South Australian Health and Medical Research Institute, Adelaide, Australia.'}, {'ForeName': 'MyNgan', 'Initials': 'M', 'LastName': 'Duong', 'Affiliation': 'GenesisCare, Adelaide, Australia.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': 'GenesisCare, Adelaide, Australia.'}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Bursill', 'Affiliation': 'Discipline of Medicine, University of Adelaide, Adelaide, Australia; South Australian Health and Medical Research Institute, Adelaide, Australia.'}, {'ForeName': 'Matthew I', 'Initials': 'MI', 'LastName': 'Worthley', 'Affiliation': 'Discipline of Medicine, University of Adelaide, Adelaide, Australia; South Australian Health and Medical Research Institute, Adelaide, Australia.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Nicholls', 'Affiliation': 'South Australian Health and Medical Research Institute, Adelaide, Australia; Monash Cardiovascular Research Centre, Victorian Heart Institute, Monash University, Clayton, Australia.'}, {'ForeName': 'Belinda A', 'Initials': 'BA', 'LastName': 'Di Bartolo', 'Affiliation': 'Discipline of Medicine, University of Adelaide, Adelaide, Australia; Kolling Institute, University of Sydney, Sydney, Australia. Electronic address: Belinda.dibartolo@sydney.edu.au.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2021.03.003'] 2735,33798930,Interlimb differences in visuomotor and dynamic adaptation during targeted reaching in children.,"While a number of studies have focused on movement (a)symmetries between the arms in adults, less is known about movement asymmetries in typically developing children. The goal of this study was to examine interlimb differences in children when adapting to novel visuomotor and dynamic conditions while performing a center-out reaching task. We tested 13 right-handed children aged 9-11 years old. Prior to movement, one of eight targets arranged radially around the start position was randomly displayed. Movements were made either with the right (dominant) arm or the left (nondominant) arm. The children participated in two experiments separated by at least one week. In one experiment, subjects were exposed to a rotated visual display (30° about the start circle); and in the other, a 1 kg mass (attached eccentrically to the forearm axis). Each experiment consisted of three blocks: pre-exposure, exposure and post-exposure. Three measures of task performance were calculated from hand trajectory data: hand-path deviation from the straight target line, direction error at peak velocity and final position error. Results showed that during visuomotor adaptation, no interlimb differences were observed for any of the three measures. During dynamic adaptation, however, a significant difference between the arms was observed at the first cycle during dynamic adaptation. With regard to the aftereffects observed during the post-exposure block, direction error data indicate considerably large aftereffects for both arms during visuomotor adaptation; and there was a significant difference between the arms, resulting in substantially larger aftereffects for the right arm. Similarly, dynamic adaptation results also showed a significant difference between the arms; and post hoc analyses indicated that aftereffects were present only for the right arm. Collectively, these findings indicate that the dominant arm advantage for developing an internal model associated with a novel visuomotor or dynamic transform, as previously shown in young adults, may already be apparent at 9 to 11-year old children.",2021,"Results showed that during visuomotor adaptation, no interlimb differences were observed for any of the three measures.","['children', '13 right-handed children aged 9-11\xa0years old']",[],['visuomotor and dynamic adaptation'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],"[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}]",,0.0427688,"Results showed that during visuomotor adaptation, no interlimb differences were observed for any of the three measures.","[{'ForeName': 'Leia B', 'Initials': 'LB', 'LastName': 'Bagesteiro', 'Affiliation': 'Department of Kinesiology, San Francisco State University, San Francisco, CA 94132, USA. Electronic address: lbb@sfsu.edu.'}, {'ForeName': 'Karina O', 'Initials': 'KO', 'LastName': 'Lima', 'Affiliation': 'Universidade Federal do ABC, Santo Andre, SP, 09210580, Brazil.'}, {'ForeName': 'Jinsung', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Kinesiology, University of Wisconsin - Milwaukee, Milwaukee, WI, 53151, USA.'}]",Human movement science,['10.1016/j.humov.2021.102788'] 2736,33802283,Short-Term Creatine Loading Improves Total Work and Repetitions to Failure but Not Load-Velocity Characteristics in Strength-Trained Men.,"This study assessed the effects of a 7-day creatine (CRE) supplementation on the load-velocity profile and repeated sub-maximal bouts in the deep squat using mean propulsive velocity (MPV) and mean propulsive power (MPP). Eleven strength-trained men (31.4 ± 5.4 years) supplemented 0.3 g·kg -1 ·d -1 CRE or a placebo (PLA, maltodextrin) for seven days in a randomized order, separated by a 30-day washout period. Prior to and after the supplementation, the subjects performed an incremental maximal strength (1RM) test, as well as 3 × 10 repetitions and a repetitions-to-failure test (RFT), all at 70% 1RM. Maximal strength remained statistically unaltered in CRE ( p = 0.107) and PLA ( p = 0.568). No statistical main effect for time ( p = 0.780) or interaction ( p = 0.737) was observed for the load-velocity profile. The number of repetitions during RFT remained statistically unaltered in both conditions (CRE: +16.8 ± 32.8%, p = 0.112; PLA: +8.2 ± 47.2%, p = 0.370), but the effect size was larger in creatine compared to placebo (g = 0.51 vs. g = 0.01). The total work during RFT increased following creatine supplementation (+23.1 ± 35.9%, p = 0.043, g = 0.70) but remained statistically unaltered in the placebo condition (+15.0 ± 60.8%, p = 0.801, g = 0.08; between conditions: p = 0.410, g = 0.25). We showed that CRE loading over seven days did not affect load-velocity characteristics but may have increased total work and power output during submaximal deep squat protocols, as was indicated by moderate effect sizes.",2021,No statistical main effect for time ( p = 0.780) or interaction ( p = 0.737) was observed for the load-velocity profile.,"['Eleven strength-trained men (31.4 ± 5.4 years', 'Strength-Trained Men']","['7-day creatine (CRE) supplementation', 'placebo', 'supplemented 0.3 g·kg -1 ·d -1 CRE or a placebo (PLA, maltodextrin']","['total work during RFT', 'load-velocity characteristics', 'Maximal strength', 'total work and power output', 'CRE', 'mean propulsive velocity (MPV) and mean propulsive power (MPP', 'Total Work and Repetitions to Failure', 'number of repetitions during RFT']","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3653283', 'cui_str': 'PROPULSIVES'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.110949,No statistical main effect for time ( p = 0.780) or interaction ( p = 0.737) was observed for the load-velocity profile.,"[{'ForeName': 'Joshua F', 'Initials': 'JF', 'LastName': 'Feuerbacher', 'Affiliation': 'Department of Molecular and Cellular Sports Medicine, German Sport University Cologne, 50933 Cologne, Germany.'}, {'ForeName': 'Valerian', 'Initials': 'V', 'LastName': 'von Schöning', 'Affiliation': 'Department of Molecular and Cellular Sports Medicine, German Sport University Cologne, 50933 Cologne, Germany.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Melcher', 'Affiliation': 'Department of Molecular and Cellular Sports Medicine, German Sport University Cologne, 50933 Cologne, Germany.'}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Notbohm', 'Affiliation': 'Department of Molecular and Cellular Sports Medicine, German Sport University Cologne, 50933 Cologne, Germany.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Freitag', 'Affiliation': 'Department of Molecular and Cellular Sports Medicine, German Sport University Cologne, 50933 Cologne, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Schumann', 'Affiliation': 'Department of Molecular and Cellular Sports Medicine, German Sport University Cologne, 50933 Cologne, Germany.'}]",Nutrients,['10.3390/nu13030826'] 2737,33802012,Urinary Titin N-Fragment Evaluation in a Randomized Controlled Trial of Beta-Hydroxy-Beta-Methylbutyrate for Acute Mild Trauma in Older Adults.,"The effects of beta-hydroxy-beta-methylbutyrate (HMB) complex administration and the significance of titin, a biomarker of muscle injury, in elderly minor trauma patients in acute phase has not been established. In this single-center, randomized controlled study, trauma patients aged ≥ 70 years with an injury severity score < 16 were included. Titin values on days 1 and 3 were measured and the intervention group received HMB complex (2.4 g of HMB + 14 g of glutamine + 14 g of arginine) and the control group received glutamine complex (7.2 g of protein including 6 g of glutamine). The cross-sectional area of the rectus femoris (RFCSA) on ultrasound, grip strength, and the Barthel Index were assessed on the first day of rehabilitation and after 2 weeks. We analyzed 24 HMB and 25 control participants. Titin values on day 3 correlated with grip strength ( r = -0.34, p = 0.03) and the Barthel Index ( r = -0.39, p = 0.01) at follow-up. HMB complex supplementation had no effect on the RFCSA (2.41 vs. 2.45 cm 2 , p = 0.887), grip strength (13.3 vs. 13.1 kg, p = 0.946), or the Barthel Index (20.0 vs. 50.0, p = 0.404) at follow-up. Titin values might associate with subsequent physical function. Short-term HMB complex supplementation from acute phase did not ameliorate muscle injury.",2021,"Titin values on day 3 correlated with grip strength ( r = -0.34, p = 0.03) and the Barthel Index ( r = -0.39, p = 0.01) at follow-up.","['trauma patients aged ≥ 70 years with an injury severity score < 16 were included', 'Acute Mild Trauma in Older Adults', 'elderly minor trauma patients']","['beta-hydroxy-beta-methylbutyrate (HMB) complex', 'glutamine complex (7.2 g of protein including 6 g of glutamine', 'HMB complex', 'Beta-Hydroxy-Beta-Methylbutyrate', 'HMB complex supplementation', 'HMB + 14 g of glutamine + 14 g of arginine']","['Barthel Index', 'RFCSA', 'Titin values', 'grip strength', 'ultrasound, grip strength, and the Barthel Index']","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021504', 'cui_str': 'Injury severity score'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0026193', 'cui_str': 'Minor'}]","[{'cui': 'C0053454', 'cui_str': '3-hydroxyisovaleric acid'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C1318184', 'cui_str': '14G'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}]","[{'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0283134', 'cui_str': 'Titin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]",,0.066662,"Titin values on day 3 correlated with grip strength ( r = -0.34, p = 0.03) and the Barthel Index ( r = -0.39, p = 0.01) at follow-up.","[{'ForeName': 'Hidehiko', 'Initials': 'H', 'LastName': 'Nakano', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Hitachi General Hospital, Hitachi, Ibaraki 317-0077, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Hitachi General Hospital, Hitachi, Ibaraki 317-0077, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Mochizuki', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Hitachi General Hospital, Hitachi, Ibaraki 317-0077, Japan.'}, {'ForeName': 'Hiromu', 'Initials': 'H', 'LastName': 'Naraba', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Hitachi General Hospital, Hitachi, Ibaraki 317-0077, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Hitachi General Hospital, Hitachi, Ibaraki 317-0077, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Sonoo', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Hitachi General Hospital, Hitachi, Ibaraki 317-0077, Japan.'}, {'ForeName': 'Yujiro', 'Initials': 'Y', 'LastName': 'Matsuishi', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki 305-8575, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Ogawa', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki 305-8575, Japan.'}, {'ForeName': 'Nobutake', 'Initials': 'N', 'LastName': 'Shimojo', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki 305-8575, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki 305-8575, Japan.'}, {'ForeName': 'Kensuke', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Hitachi General Hospital, Hitachi, Ibaraki 317-0077, Japan.'}]",Nutrients,['10.3390/nu13030899'] 2738,33801790,Reduced Interaction of Aggregated α-Synuclein and VAMP2 by Environmental Enrichment Alleviates Hyperactivity and Anxiety in a Model of Parkinson's Disease.,"Parkinson's disease (PD) is a prevalent motor disease caused by the accumulation of mutated α-synuclein (α-Syn); however, its early stages are also characterized by non-motor symptoms, such as olfactory loss, cognitive decline, depression, and anxiety. The therapeutic effects of environmental enrichment (EE) on motor recovery have been reported, but its effects on non-motor symptoms remain unclear. Herein, we reveal the beneficial effects of EE on PD-related non-motor symptoms and changes in synaptic plasticity in the nucleus accumbens. To investigate its therapeutic effects in the early phase of PD, we randomly assigned eight-month-old mice overexpressing human A53T (hA53T) α-Syn to either the EE or standard condition groups for two months. Next, we performed behavioral tests and biochemical and histological analyses at 10 months of age. EE significantly alleviated locomotor hyperactivity and anxiety during the early stages of PD. It normalized the levels of tyrosine hydroxylase, phosphorylated and oligomeric α-Syn, and soluble N -ethylmaleimide-sensitive factor attachment protein receptor complex-forming proteins, including synaptosomal-associated protein, 25 kDa, syntaxin1, and vesicle-associated membrane protein 2 (VAMP2). Moreover, the interactions between VAMP2 and pSer129 α-Syn were markedly reduced following EE. The restoration of synaptic vesicle transportation status may underlie the neuroprotective effects of EE in hA53T α-Syn mice.",2021,"It normalized the levels of tyrosine hydroxylase, phosphorylated and oligomeric α-Syn, and soluble N -ethylmaleimide-sensitive factor attachment protein receptor complex-forming proteins, including synaptosomal-associated protein, 25 kDa, syntaxin1, and vesicle-associated membrane protein 2 (VAMP2).","['hA53T α-Syn mice', ""Parkinson's disease (PD""]","['old mice overexpressing human A53T (hA53T) α-Syn to either the EE or standard condition', 'environmental enrichment (EE']","['VAMP2 and pSer129 α-Syn', 'locomotor hyperactivity and anxiety']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0165073', 'cui_str': 'Synuclein'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0165073', 'cui_str': 'Synuclein'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0148340', 'cui_str': 'Synaptobrevin 2'}, {'cui': 'C0165073', 'cui_str': 'Synuclein'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0291901,"It normalized the levels of tyrosine hydroxylase, phosphorylated and oligomeric α-Syn, and soluble N -ethylmaleimide-sensitive factor attachment protein receptor complex-forming proteins, including synaptosomal-associated protein, 25 kDa, syntaxin1, and vesicle-associated membrane protein 2 (VAMP2).","[{'ForeName': 'Kyungri', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul 03722, Korea.'}, {'ForeName': 'Soohyun', 'Initials': 'S', 'LastName': 'Wi', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul 03080, Korea.'}, {'ForeName': 'Jung Hwa', 'Initials': 'JH', 'LastName': 'Seo', 'Affiliation': 'Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul 03722, Korea.'}, {'ForeName': 'Soonil', 'Initials': 'S', 'LastName': 'Pyo', 'Affiliation': 'Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul 03722, Korea.'}, {'ForeName': 'Sung-Rae', 'Initials': 'SR', 'LastName': 'Cho', 'Affiliation': 'Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul 03722, Korea.'}]",Genes,['10.3390/genes12030392'] 2739,33801720,The Acute Effect of Foam Rolling and Vibration Foam Rolling on Drop Jump Performance.,"The purpose of this study was to examine the acute effect of foam rolling and vibration foam rolling on drop jump performance. The optimal time interval between warm-up using foam rolling or vibration foam rolling and drop jump performance was identified. This study included 16 male NCAA Division I college volleyball athletes. Three interventions were performed in a randomized order: the foam rolling exercise (FRE), vibration foam rolling exercise (VFRE), and static rest (control). The drop jump was performed before interventions, as well as 2 and 5 min after interventions. The FRE exhibited higher values for drop jump height (DJH) ( p = 0.001; η 2 = 0.382; statistical power = 0.964) and mean power generation at the hip joint ( p = 0.006; η 2 = 0.277; statistical power = 0.857) at 2 min compared with before intervention but not at 5 min ( p > 0.05). However, the VFRE showed no significant changes in DJH ( p > 0.05), and found that hip power was decreased at 5 min ( p = 0.027; η 2 = 0.214; statistical power = 0.680). The FRE completed in 2 min before rapid single action competition (sprint, long jump, triple jump, etc.) could increase sports performance.",2021,The FRE exhibited higher values for drop jump height (DJH) ( p = 0.001; η 2 = 0.382; statistical power = 0.964) and mean power generation at the hip joint ( p = 0.006; η 2 = 0.277; statistical power = 0.857) at 2 min compared with before intervention but not at 5 min ( p > 0.05).,['16 male NCAA Division I college volleyball athletes'],"['Foam Rolling and Vibration Foam Rolling', 'foam rolling exercise (FRE), vibration foam rolling exercise (VFRE), and static rest (control', 'foam rolling and vibration foam rolling', 'VFRE']","['hip power', 'sports performance', 'DJH']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C1956059', 'cui_str': 'Volleyball'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0871966', 'cui_str': 'Sports Performance'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}]",16.0,0.0301769,The FRE exhibited higher values for drop jump height (DJH) ( p = 0.001; η 2 = 0.382; statistical power = 0.964) and mean power generation at the hip joint ( p = 0.006; η 2 = 0.277; statistical power = 0.857) at 2 min compared with before intervention but not at 5 min ( p > 0.05).,"[{'ForeName': 'Wei-Chi', 'Initials': 'WC', 'LastName': 'Tsai', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Zuoying Branch of Kaohsiung Armed Forces General Hospital, Kaohsiung 813, Taiwan.'}, {'ForeName': 'Zong-Rong', 'Initials': 'ZR', 'LastName': 'Chen', 'Affiliation': 'Department of Athletic Performance, National University of Kaohsiung, Kaohsiung 811, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph18073489'] 2740,33801621,The Effect of Autoregulated Flywheel and Traditional Strength Training on Training Load Progression and Motor Skill Performance in Youth Athletes.,"BACKGROUND The effects of flywheel resistance training (FRT) on youth are relatively unknown. The aim of this study was to compare the effects of autoregulated FRT with traditional strength training (TST) on jumping, running performance and resistance training load progression in youth athletes. Thirty youth athletes (11.8 ± 0.9 yr) were matched for peak height velocity (PHV) status and block-randomised into two groups: FRT ( n = 15, PHV -0.8 ± 1.6) and TST ( n = 15, PHV -0.8 ± 1.5). Twelve resistance training sessions over a six-week intervention with flywheel or barbell squats were performed using autoregulated load prescription. Squat jump (SJ); countermovement jump (CMJ); and 10 m, 20 m and 30 m sprints were assessed pre- and post-intervention. The external load increased similarly for FRT and TST ( z = 3.8, p = 0.06). SJ increased for both groups ( p < 0.05) but running performance was unaffected ( p > 0.05). CONCLUSIONS FRT resulted in similar load progression and motor skill development in youth athletes as TST, but the perceived exertion was less. Autoregulation is a practical method for adjusting training load during FRT and should be considered as an alternative to autoregulated TST.",2021,"SJ increased for both groups ( p < 0.05) but running performance was unaffected ( p > 0.05). ","['Youth Athletes', 'Thirty youth athletes (11.8 ± 0.9 yr) were matched for peak height velocity (PHV) status and block-randomised into two groups', 'youth athletes']","['FRT', 'flywheel resistance training (FRT', 'autoregulated FRT with traditional strength training (TST', 'Autoregulated Flywheel and Traditional Strength Training']","['external load increased similarly for FRT and TST', 'running performance', 'load progression and motor skill development', 'SJ', 'Training Load Progression and Motor Skill Performance', 'Squat jump (SJ); countermovement jump (CMJ); and 10 m, 20 m and']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}]",30.0,0.0240601,"SJ increased for both groups ( p < 0.05) but running performance was unaffected ( p > 0.05). ","[{'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Westblad', 'Affiliation': 'Department of Physiology, Nutrition and Biomechanics, The Swedish School of Sport and Health Sciences, 114 33 Stockholm, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Petré', 'Affiliation': 'Department of Physiology, Nutrition and Biomechanics, The Swedish School of Sport and Health Sciences, 114 33 Stockholm, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kårström', 'Affiliation': 'Swedish Winter Sports Research Centre, Department of Health Sciences, Mid Sweden University, 831 25 Östersund, Sweden.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Psilander', 'Affiliation': 'Department of Physiology, Nutrition and Biomechanics, The Swedish School of Sport and Health Sciences, 114 33 Stockholm, Sweden.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Björklund', 'Affiliation': 'Swedish Winter Sports Research Centre, Department of Health Sciences, Mid Sweden University, 831 25 Östersund, Sweden.'}]",International journal of environmental research and public health,['10.3390/ijerph18073479'] 2741,33801604,The Seneb's Enigma: Impact of a Hybrid Personal and Social Responsibility and Gamification Model-Based Practice on Motivation and Healthy Habits in Physical Education.,"Increasing physical activity (PA) and personal and social values are two of the greatest demands in the current educational system. This study examined the effects of a program based on the hybridization of the Personal and Social Responsibility Model and gamification. A total of 58 students (13.89 years old, SD = 1.14) in two groups (experimental and control) participated during a complete academic year. Motivation, physical activity and sedentary behavior were assessed through questionnaires. Physical fitness was evaluated using previously validated field tests. The results showed significant differences over time between the experimental group (EG) and control group (CG) in afterschool physical activity (APA) during the weekend ( p = 0.003), sedentary time ( p = 0.04) and speed-agility ( p = 0.04). There were no significant differences in motivation. In reference to the intervention, the speed-agility ( p = 0.000), strength ( p = 0.000), agility ( p = 0.000), cardiorespiratory fitness ( p = 0.001), APA-weekend ( p = 0.000), APA-week ( p = 0.000) and sedentary time ( p = 0.000) increased significantly in the EG. The speed-agility ( p = 0.000), APA-weekend ( p = 0.03) and sedentary time ( p = 0.008) increased in the CG. The implementation of a program based on the hybridization of pedagogical models can be useful in producing improvements in physical fitness, physical activity and sedentary behaviors.",2021,"In reference to the intervention, the speed-agility ( p = 0.000), strength ( p = 0.000), agility ( p = 0.000), cardiorespiratory fitness ( p = 0.001), APA-weekend ( p = 0.000), APA-week ( p = 0.000) and sedentary time ( p = 0.000) increased significantly in the EG.","['58 students (13.89 years old, SD = 1.14) in two groups (experimental and control) participated during a complete academic year']",['Hybrid Personal and Social Responsibility and Gamification Model-Based Practice'],"['cardiorespiratory fitness', 'Motivation, physical activity and sedentary behavior', 'sedentary time', 'speed-agility', 'motivation', 'Increasing physical activity (PA) and personal and social values', 'physical fitness, physical activity and sedentary behaviors', 'afterschool physical activity (APA', 'Physical fitness']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517492', 'cui_str': '1.14'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0037433', 'cui_str': 'Responsibility, Social'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity'}, {'cui': 'C0037439', 'cui_str': 'Values, Social'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}]",58.0,0.00743298,"In reference to the intervention, the speed-agility ( p = 0.000), strength ( p = 0.000), agility ( p = 0.000), cardiorespiratory fitness ( p = 0.001), APA-weekend ( p = 0.000), APA-week ( p = 0.000) and sedentary time ( p = 0.000) increased significantly in the EG.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Melero-Canas', 'Affiliation': 'Department of Physical Activity and Sport, CEI Campus Mare Nostrum, University of Murcia, 30720 Santiago de la Ribera, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Manzano-Sánchez', 'Affiliation': 'Department of Physical Activity and Sport, CEI Campus Mare Nostrum, University of Murcia, 30720 Santiago de la Ribera, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Navarro-Ardoy', 'Affiliation': 'Department of Physical Education and Sports, School of Sport Sciences, University of Granada, 18071 Granada, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Morales-Baños', 'Affiliation': 'Department of Physical Activity and Sport, CEI Campus Mare Nostrum, University of Murcia, 30720 Santiago de la Ribera, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Valero-Valenzuela', 'Affiliation': 'Department of Physical Activity and Sport, CEI Campus Mare Nostrum, University of Murcia, 30720 Santiago de la Ribera, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph18073476'] 2742,33801559,Eye-Tracking Training Improves Inhibitory Control in Children with Attention-Deficit/Hyperactivity Disorder.,"Disinhibition is a common sign among children with attention-deficit/hyperactivity disorder (ADHD). The present study examined the effect of computerized eye-tracking training to improve inhibitory control in ADHD children. Thirty-two ADHD children (mean age = 8.4 years) were recruited. Half of the participants underwent 240 min of eye-tracking training over two weeks (i.e., experimental group), while the other half did not receive any training (i.e., control group). After training, the experimental group exhibited significant improvements in neuropsychological tests of inhibition, such as faster reaction time in the incongruent condition of the Flanker test, more unique designs in the Category Fluency and Five-Point Tests, and a faster completion time in Trail 2 of the Children's Color Trail Test. The control group did not show significant changes in any of these tests. Our findings support the use of eye-tracking training to improve the inhibitory control of ADHD children.",2021,"After training, the experimental group exhibited significant improvements in neuropsychological tests of inhibition, such as faster reaction time in the incongruent condition of the Flanker test, more unique designs in the Category Fluency and Five-Point Tests, and a faster completion time in Trail 2 of the Children's Color Trail Test.","['children with attention-deficit/hyperactivity disorder (ADHD', 'Children with Attention-Deficit/Hyperactivity Disorder', 'ADHD children', 'Thirty-two ADHD children (mean age = 8.4 years) were recruited']","['computerized eye-tracking training', 'eye-tracking training', 'Eye-Tracking Training']","['neuropsychological tests of inhibition, such as faster reaction time']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",32.0,0.00781814,"After training, the experimental group exhibited significant improvements in neuropsychological tests of inhibition, such as faster reaction time in the incongruent condition of the Flanker test, more unique designs in the Category Fluency and Five-Point Tests, and a faster completion time in Trail 2 of the Children's Color Trail Test.","[{'ForeName': 'Tsz Lok', 'Initials': 'TL', 'LastName': 'Lee', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong, China.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Yeung', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Sophia L', 'Initials': 'SL', 'LastName': 'Sze', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong, China.'}, {'ForeName': 'Agnes S', 'Initials': 'AS', 'LastName': 'Chan', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong, China.'}]",Brain sciences,['10.3390/brainsci11030314'] 2743,33801295,"The Influence of EMG-Triggered Robotic Movement on Walking, Muscle Force and Spasticity after an Ischemic Stroke.","Background and Objectives : Application of the EMG-driven robotic training in everyday therapeutic processes is a modern and innovative form of neurorehabilitation among patients after stroke. Active participation of the patient contributes to significantly higher activation of the sensorimotor network during active motor control rather than during passive movement. The study objective was to determine the effect of electromyographic triggering (EMG-triggered) robotic rehabilitation device treatment on walking, muscle force, and spasticity after an ischemic stroke. Materials and Methods : A total of 60 participants with impaired motor function and gait after subacute stroke were included in the study. Each patient was randomly assigned to an intervention or control group (IG or CG). All patients, except standard therapy, underwent 1 additional session of therapy per day, 5 days a week for 6 weeks. IG had 30 min of training on the robot, while CG received exercises on the lower limb rotor. The subjects were assessed with Timed Up and Go Test (TUG), Ashworth scale, knee range of motion (ROM), Lovett Scale, and tight circumference at baseline and at weeks 2, 4, and 6. Results : For seven parameters, the values credibly increased between consecutive measurements, and for the Ashworth scale, they credibly decreased. The biggest changes were observed for the measurements made with Lovett scale. The average thigh circumference as measured 5 and 15 cm above the knee increased credibly more in the robot condition, as compared to control condition. Additionally, the decrease in Ashworth values over time, although statistically credible in both groups, was credibly higher in the robot condition. Conclusion : The inclusion of the EMG-triggered neurorehabilitation robot in the patient's daily rehabilitation plan has a positive effect on outcomes of the treatment. Both proposed rehabilitation protocols significantly improved patients' condition regarding all measured outcomes, but the spasticity and thigh circumference improved significantly better in the robotic group in comparison to controls.",2021,"Both proposed rehabilitation protocols significantly improved patients' condition regarding all measured outcomes, but the spasticity and thigh circumference improved significantly better in the robotic group in comparison to controls.","['60 participants with impaired motor function and gait after subacute stroke', 'patients after stroke']","['intervention or control group (IG or CG', 'electromyographic triggering (EMG-triggered) robotic rehabilitation device treatment', 'Materials and Methods ', 'EMG-Triggered Robotic Movement', 'EMG-driven robotic training']","['Timed Up and Go Test (TUG), Ashworth scale, knee range of motion (ROM), Lovett Scale, and tight circumference', 'spasticity and thigh circumference', 'walking, muscle force, and spasticity', 'average thigh circumference', 'Ashworth values']","[{'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0576094', 'cui_str': 'Knee joint - range of movement'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",60.0,0.0138102,"Both proposed rehabilitation protocols significantly improved patients' condition regarding all measured outcomes, but the spasticity and thigh circumference improved significantly better in the robotic group in comparison to controls.","[{'ForeName': 'Patrycja', 'Initials': 'P', 'LastName': 'Lewandowska-Sroka', 'Affiliation': 'Faculty of Rehabilitation, State Higher Vocational School in Nowy Sacz, 33-300 Nowy Sącz, Poland.'}, {'ForeName': 'Rafał', 'Initials': 'R', 'LastName': 'Stabrawa', 'Affiliation': 'Faculty of Rehabilitation, State Higher Vocational School in Nowy Sacz, 33-300 Nowy Sącz, Poland.'}, {'ForeName': 'Dominika', 'Initials': 'D', 'LastName': 'Kozak', 'Affiliation': 'Clinical Department, Egzotech sp. z o.o., 44-100 Gliwice, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Poświata', 'Affiliation': 'Clinical Department, Egzotech sp. z o.o., 44-100 Gliwice, Poland.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Łysoń-Uklańska', 'Affiliation': 'Faculty of Rehabilitation, The Jozef Pilsudski University of Physical Education, 00-968 Warsaw, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Bienias', 'Affiliation': 'Faculty of Rehabilitation, The Jozef Pilsudski University of Physical Education, 00-968 Warsaw, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Roksela', 'Affiliation': 'Faculty of Automatic Control, Electronics and Computer Science, Silesian University of Technology, 44-100 Gliwice, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Kliś', 'Affiliation': 'Faculty of Automatic Control, Electronics and Computer Science, Silesian University of Technology, 44-100 Gliwice, Poland.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Mikulski', 'Affiliation': 'Clinical Department, Egzotech sp. z o.o., 44-100 Gliwice, Poland.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina57030227'] 2744,33801251,Caffeine-Induced Effects on Human Skeletal Muscle Contraction Time and Maximal Displacement Measured by Tensiomyography.,"Studies on muscle activation time in sport after caffeine supplementation confirmed the effectiveness of caffeine. The novel approach was to determine whether a dose of 9 mg/kg/ body mass (b.m.) of caffeine affects the changes of contraction time and the displacement of electrically stimulated muscle (gastrocnemius medialis) in professional athletes who regularly consume products rich in caffeine and do not comply with the caffeine discontinuation period requirements. The study included 40 professional male handball players (age = 23.13 ± 3.51, b.m. = 93.51 ± 15.70 kg, height 191 ± 7.72, BMI = 25.89 ± 3.10). The analysis showed that in the experimental group the values of examined parameters were significantly reduced ( p ≤ 0.001) (contraction time: before = 20.60 ± 2.58 ms/ after = 18.43 ± 3.05 ms; maximal displacement: before = 2.32 ± 0.80 mm/after = 1.69 ± 0.51 mm). No significant changes were found in the placebo group. The main achievement of this research was to demonstrate that caffeine at a dose of 9 mg/kg in professional athletes who regularly consume products rich in caffeine has a direct positive effect on the mechanical activity of skeletal muscle stimulated by an electric pulse.",2021,The analysis showed that in the experimental group the values of examined parameters were significantly reduced ( p ≤ 0.001) (contraction time: before = 20.60 ± 2.58 ms/ after = 18.43 ± 3.05 ms; maximal displacement: before = 2.32 ± 0.80 mm/after = 1.69 ± 0.51 mm).,"['professional athletes who regularly consume products rich in caffeine and do not comply with the caffeine discontinuation period requirements', '40 professional male handball players (age = 23.13 ± 3.51, b.m. = 93.51 ± 15.70 kg, height 191 ± 7.72, BMI = 25.89 ± 3.10']","['placebo', 'caffeine', 'Caffeine']",['Human Skeletal Muscle Contraction Time and Maximal Displacement'],"[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0336936', 'cui_str': 'Handball'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0541840', 'cui_str': 'Contraction skeletal muscle'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}]",40.0,0.0881372,The analysis showed that in the experimental group the values of examined parameters were significantly reduced ( p ≤ 0.001) (contraction time: before = 20.60 ± 2.58 ms/ after = 18.43 ± 3.05 ms; maximal displacement: before = 2.32 ± 0.80 mm/after = 1.69 ± 0.51 mm).,"[{'ForeName': 'Przemysław', 'Initials': 'P', 'LastName': 'Domaszewski', 'Affiliation': 'Faculty of Physical Education and Physiotherapy, Opole University of Technology, 45-758 Opole, Poland.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Pakosz', 'Affiliation': 'Faculty of Physical Education and Physiotherapy, Opole University of Technology, 45-758 Opole, Poland.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Konieczny', 'Affiliation': 'Faculty of Physical Education and Physiotherapy, Opole University of Technology, 45-758 Opole, Poland.'}, {'ForeName': 'Dawid', 'Initials': 'D', 'LastName': 'Bączkowicz', 'Affiliation': 'Faculty of Physical Education and Physiotherapy, Opole University of Technology, 45-758 Opole, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Sadowska-Krępa', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education, 40-065 Katowice, Poland.'}]",Nutrients,['10.3390/nu13030815'] 2745,33801247,"A Ketogenic Low-Carbohydrate High-Fat Diet Increases LDL Cholesterol in Healthy, Young, Normal-Weight Women: A Randomized Controlled Feeding Trial.","Ketogenic low-carbohydrate high-fat (LCHF) diets are popular among young, healthy, normal-weight individuals for various reasons. We aimed to investigate the effect of a ketogenic LCHF diet on low-density lipoprotein (LDL) cholesterol (primary outcome), LDL cholesterol subfractions and conventional cardiovascular risk factors in the blood of healthy, young, and normal-weight women. The study was a randomized, controlled, feeding trial with crossover design. Twenty-four women were assigned to a 4 week ketogenic LCHF diet (4% carbohydrates; 77% fat; 19% protein) followed by a 4 week National Food Agency recommended control diet (44% carbohydrates; 33% fat; 19% protein), or the reverse sequence due to the crossover design. Treatment periods were separated by a 15 week washout period. Seventeen women completed the study and treatment effects were evaluated using mixed models. The LCHF diet increased LDL cholesterol in every woman with a treatment effect of 1.82 mM ( p < 0.001). In addition, Apolipoprotein B-100 (ApoB), small, dense LDL cholesterol as well as large, buoyant LDL cholesterol increased ( p < 0.001, p < 0.01, and p < 0.001, respectively). The data suggest that feeding healthy, young, normal-weight women a ketogenic LCHF diet induces a deleterious blood lipid profile. The elevated LDL cholesterol should be a cause for concern in young, healthy, normal-weight women following this kind of LCHF diet.",2021,The LCHF diet increased LDL cholesterol in every woman with a treatment effect of 1.82 mM ( p < 0.001).,"['Twenty-four women', 'Seventeen women', 'healthy, young, and normal-weight women', 'Healthy, Young', 'Normal-Weight Women']","['Ketogenic Low-Carbohydrate High-Fat Diet', 'Ketogenic low-carbohydrate high-fat (LCHF) diets', 'ketogenic LCHF diet (4% carbohydrates; 77% fat; 19% protein) followed by a 4 week National Food Agency recommended control diet', 'ketogenic LCHF diet']","['Apolipoprotein B-100 (ApoB), small, dense LDL cholesterol', 'buoyant LDL cholesterol', 'low-density lipoprotein (LDL) cholesterol (primary outcome), LDL cholesterol subfractions and conventional cardiovascular risk factors', 'deleterious blood lipid profile', 'LDL cholesterol']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0521974', 'cui_str': 'High fat diet'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}]","[{'cui': 'C0205666', 'cui_str': 'Apolipoprotein B-100'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}]",24.0,0.0124293,The LCHF diet increased LDL cholesterol in every woman with a treatment effect of 1.82 mM ( p < 0.001).,"[{'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Burén', 'Affiliation': 'Department of Food, Nutrition and Culinary Science, Umeå University, 90187 Umeå, Sweden.'}, {'ForeName': 'Madelene', 'Initials': 'M', 'LastName': 'Ericsson', 'Affiliation': 'Department of Medical Biosciences, Physiological Chemistry, Umeå University, 90187 Umeå, Sweden.'}, {'ForeName': 'Nágila Raquel Teixeira', 'Initials': 'NRT', 'LastName': 'Damasceno', 'Affiliation': 'Department of Nutrition, School of Public Health, University of Sao Paulo, 05508-060 Sao Paulo, Brazil.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Sjödin', 'Affiliation': 'Department of Food, Nutrition and Culinary Science, Umeå University, 90187 Umeå, Sweden.'}]",Nutrients,['10.3390/nu13030814'] 2746,33823845,Application of 3D modeling and fusion technology of medical image data in image teaching.,"BACKGROUND We combined anatomy with imaging, transformed the 2D information of various imaging techniques into 3D information, and form the assessment system of real medical imaging cases in order to make up for the deficiencies in the current teaching of the medical imaging technology students. METHODS A total of 460 medical imaging students were selected and randomly divided into two groups. The research group received the teaching of the fusion of the original CT and MR data 3D model and the original image combined with 3D anatomical image. CT and MRI data are imported through load DICOM of 3D slicer. Different tissues and organs are segmented by threshold and watershed algorithm of segment editor module. Models are exported through export / import models and label maps in segmentation. Save the NHDR file of the original data and Obj file of the corresponding model through save the NHDR and corresponding Obj files are loaded into probe 1.0 software. The software can give different colors to the three-dimensional models of different organs or tissues to display the stereo models and related data, and display the hook edges of organ models on coronal, sagittal and axial images. At the same time, annotation can be established in the corresponding anatomical position. Finally, it can be saved as a single file of Hwl, and the teaching can be opened at any time through the program of probe 1.0. Statistical analysis Academic self-efficacy scale and Self-directed learning ability scale was adopted by self-directed learning evaluation scale between two groups. RESULTS Compare the theoretical scores and case analysis scores of the two groups. The scores of the study and control groups were significantly higher than those of the control group. Before the experiment, no significant difference was detected in the self-efficacy of learning ability and learning behavior between the two groups, while after the experiment, these differences between the two groups were statistically significan. Moreover, the learning ability self-efficacy and learning behavior of the two groups of students after the experiment was significantly higher than that before the experiment. The self-efficacy of the learning behavior of the control group was higher after the experiment than that before the experiment, albeit the difference was not statistically significant. CONCLUSIONS The modern, information-based and humanized experimental teaching mode will be constantly improved under the support of PACS system in order to optimize the medical imaging teaching activities for the development of modern medical education.",2021,"Before the experiment, no significant difference was detected in the self-efficacy of learning ability and learning behavior between the two groups, while after the experiment, these differences between the two groups were statistically significan.",['A total of 460 medical imaging students'],[],"['Statistical analysis Academic self-efficacy scale and Self-directed learning ability scale', 'learning ability self-efficacy and learning behavior', 'learning behavior', 'self-efficacy of learning ability and learning behavior']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",[],"[{'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0233832', 'cui_str': 'Learning ability'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",460.0,0.0216584,"Before the experiment, no significant difference was detected in the self-efficacy of learning ability and learning behavior between the two groups, while after the experiment, these differences between the two groups were statistically significan.","[{'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Yuan', 'Affiliation': 'Department of Imaging, Yi-Ji Shan Hospital, Wannan Medical College, Zheshan West Road on the 2nd, Wuhu, 241000, Anhui, China.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Imaging, Yi-Ji Shan Hospital, Wannan Medical College, Zheshan West Road on the 2nd, Wuhu, 241000, Anhui, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhai', 'Affiliation': 'Department of Imaging, Yi-Ji Shan Hospital, Wannan Medical College, Zheshan West Road on the 2nd, Wuhu, 241000, Anhui, China.'}, {'ForeName': 'Yadi', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Imaging, Yi-Ji Shan Hospital, Wannan Medical College, Zheshan West Road on the 2nd, Wuhu, 241000, Anhui, China.'}, {'ForeName': 'Qingxiang', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Imaging, Yi-Ji Shan Hospital, Wannan Medical College, Zheshan West Road on the 2nd, Wuhu, 241000, Anhui, China.'}, {'ForeName': 'Zhongxiao', 'Initials': 'Z', 'LastName': 'Tan', 'Affiliation': 'Department of Imaging, Yi-Ji Shan Hospital, Wannan Medical College, Zheshan West Road on the 2nd, Wuhu, 241000, Anhui, China.'}, {'ForeName': 'Gao', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Hewanlan digital S T CO.LTD, Shuihu Road on Room204 First building, HeFei, 230000, Anhui, China.'}, {'ForeName': 'Kangle', 'Initials': 'K', 'LastName': 'Zhuang', 'Affiliation': 'Hewanlan digital S T CO.LTD, Shuihu Road on Room204 First building, HeFei, 230000, Anhui, China.'}, {'ForeName': 'Jianying', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Imaging, Yi-Ji Shan Hospital, Wannan Medical College, Zheshan West Road on the 2nd, Wuhu, 241000, Anhui, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Hewanlan digital S T CO.LTD, Shuihu Road on Room204 First building, HeFei, 230000, Anhui, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Qiang', 'Affiliation': 'Department of Imaging, Yi-Ji Shan Hospital, Wannan Medical College, Zheshan West Road on the 2nd, Wuhu, 241000, Anhui, China.'}, {'ForeName': 'Xuefei', 'Initials': 'X', 'LastName': 'Shao', 'Affiliation': 'Department of Imaging, Yi-Ji Shan Hospital, Wannan Medical College, Zheshan West Road on the 2nd, Wuhu, 241000, Anhui, China. drshao@163.com.'}]",BMC medical education,['10.1186/s12909-021-02620-z'] 2747,33775745,Different neurocognitive profiles of risperidone and aripiprazole in the FIRST episode of psychosis: A 3-year follow-up comparison.,"Cognitive deficits have been recognized as a central feature of schizophrenia spectrum disorders. These deficits are often related to more severe negative symptoms, as well as a poorer adjustment in social functioning. Therefore, it is important to improve cognitive performance from the onset of the disease. In this study, we compared the effects of two atypical antipsychotics, risperidone and aripiprazole, on cognition. The data used in the present investigation were obtained from a large epidemiological cohort of patients with a first episode of psychosis who were treated in a longitudinal intervention programme. The patients included in the program were randomized to treatment with risperidone or aripiprazole and were assessed for cognitive function at baseline and 3 years later. The final sample consisted of 115 patients, 55 of whom were initially assigned to risperidone and 60 to aripiprazole. The groups did not show significant differences in their sociodemographic or clinical characteristics at intake. Longitudinal analyses showed that risperidone-treated patients improved in the processing speed domain at the 3-year follow-up, while the aripiprazole group showed better scores for the executive function domain. Our study shows slight differences between the effects of risperidone and aripiprazole on cognition, suggesting different patterns of efficacy on cognitive function that may warrant more thorough research to determine the beneficial effects of these drugs on cognition. Future studies should evaluate the effects of these treatments over longer follow-up periods using standardized tools for the assessment of cognitive function.",2021,"Longitudinal analyses showed that risperidone-treated patients improved in the processing speed domain at the 3-year follow-up, while the aripiprazole group showed better scores for the executive function domain.","['patients with a first episode of psychosis who were treated in a longitudinal intervention programme', '115 patients, 55 of whom were initially assigned to']","['risperidone or aripiprazole', 'atypical antipsychotics, risperidone and aripiprazole', 'risperidone', 'aripiprazole', 'risperidone and aripiprazole']","['cognitive performance', 'processing speed domain', 'cognitive function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0205182', 'cui_str': 'Atypical'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}]","[{'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",115.0,0.0170887,"Longitudinal analyses showed that risperidone-treated patients improved in the processing speed domain at the 3-year follow-up, while the aripiprazole group showed better scores for the executive function domain.","[{'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Setién-Suero', 'Affiliation': 'University Hospital Marqués de Valdecilla, Department of Psychiatry, School of Medicine, University of Cantabria, Santander, Spain; IDIVAL, Valdecilla Biomedical Research Institute, Santander, Spain.. Electronic address: setiensuero@hotmail.com.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Ortiz-García de la Foz', 'Affiliation': 'University Hospital Marqués de Valdecilla, Department of Psychiatry, School of Medicine, University of Cantabria, Santander, Spain; IDIVAL, Valdecilla Biomedical Research Institute, Santander, Spain.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Suárez-Pinilla', 'Affiliation': 'University Hospital Marqués de Valdecilla, Department of Psychiatry, School of Medicine, University of Cantabria, Santander, Spain.'}, {'ForeName': 'Benedicto', 'Initials': 'B', 'LastName': 'Crespo-Facorro', 'Affiliation': 'CIBERSAM, Centro Investigación Biomédica en Red Salud Mental, Madrid, Spain; University Hospital Virgen del Rocío, Department of Psychiatry, Instituto de Investigación Sanitaria de Sevilla, IBiS, Sevilla, Spain; University of Sevilla, Sevilla, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Ayesa-Arriola', 'Affiliation': 'University Hospital Marqués de Valdecilla, Department of Psychiatry, School of Medicine, University of Cantabria, Santander, Spain; IDIVAL, Valdecilla Biomedical Research Institute, Santander, Spain.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2021.110309'] 2748,33774594,Systemic methylprednisolone for hearing preservation during cochlear implant surgery: A double blinded placebo-controlled trial.,"AIM To assess whether a single, peri-operative, high dose of methylprednisolone can improve the preservation of residual acoustic hearing following cochlear implantation (CI). METHODS This was a double blinded placebo-controlled trial, performed in a tertiary academic centre. The hypothesis was that methylprednisolone would improve the preservation of hearing, and lower electrode impedances. Adult patients (18-85 years) with hearing at 85 dB or better at 500 Hz in the ear to be implanted were randomly allocated to either treatment (methylprednisolone, 1g administered intravenously upon induction of anaesthesia) or control (normal saline infusion). As per standard clinical practice, all patients received a routine dose of dexamethasone (8 mg intravenously) on induction of anaesthesia. Implantation was undertaken with a slim and flexible lateral wall electrode via the round window. Surgical technique was routine, with adherence to soft surgical principles. The primary outcome was hearing preservation within 20 dB at 500 Hz, 12 months following cochlear implantation. Secondary outcomes included hearing preservation at 6 weeks and 3 months, monopolar electrode impedance, and Consonant-Vowel-Consonant (CVC) Phoneme scores at 3 and 12 months after surgery. RESULTS Forty-five patients were enrolled into the control group and 48 patients received the steroid. The number of patients achieving hearing preservation at 12 months did not differ significantly between those receiving methylprednisolone treatment and the controls. There were no differences in hearing preservation at any frequency at either 6 weeks or 3 months after implantation. Neither CVC phoneme scores nor electrode impedances differed between the groups. CONCLUSIONS This paper demonstrates that high-dose local steroid injection at surgery was not effective in preventing a loss of residual hearing, improving speech perception, or lowering electrode impedances. The findings were contrary to the experimental literature, and emerging clinical evidence that steroid elution from implant electrodes influences cochlear biology in humans. We found no evidence to support the widely-held practice of administering intravenous steroids in the perioperative period, in an attempt to preserve residual hearing.",2021,The number of patients achieving hearing preservation at 12 months did not differ significantly between those receiving methylprednisolone treatment and the controls.,"['hearing preservation during cochlear implant surgery', 'Forty-five patients were enrolled into the control group and 48 patients received the', 'residual acoustic hearing following cochlear implantation (CI', 'Adult patients (18-85 years) with hearing at 85 dB or better at 500 Hz in the ear to be implanted']","['dexamethasone', 'steroid', 'treatment (methylprednisolone, 1g administered intravenously upon induction of anaesthesia) or control (normal saline infusion', 'placebo', 'Systemic methylprednisolone', 'methylprednisolone']","['preservation of hearing, and lower electrode impedances', 'number of patients achieving hearing preservation', 'hearing preservation', 'CVC phoneme scores nor electrode impedances', 'hearing preservation at 6 weeks and 3 months, monopolar electrode impedance, and Consonant-Vowel-Consonant (CVC) Phoneme scores']","[{'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0009199', 'cui_str': 'Cochlear prosthesis'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0302559', 'cui_str': 'Implantation of cochlear prosthetic device'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}]","[{'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",45.0,0.478748,The number of patients achieving hearing preservation at 12 months did not differ significantly between those receiving methylprednisolone treatment and the controls.,"[{'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': ""O'Leary"", 'Affiliation': 'Department of Surgery - Otolaryngology, The University of Melbourne, Royal Victorian Eye and Ear Hospital, 32 Gisborne St RVEEH, Melbourne East 3002,Victoria, Australia; Cochlear Implant Clinic, Royal Victorian Eye and Ear Hospital, 32 Gisborne St, Melbourne East 3002, Australia. Electronic address: sjoleary@unimelb.edu.au.'}, {'ForeName': 'June', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'Department of Surgery - Otolaryngology, The University of Melbourne, Royal Victorian Eye and Ear Hospital, 32 Gisborne St RVEEH, Melbourne East 3002,Victoria, Australia; Department of Otorhinolaryngology - Head & Neck Surgery, Ansan Hospital, College of Medicine, Korea University, 123, Jeokgeum-ro (Street), Gojan-dong, Danwon-gu, Ansan-si, Gyeonggi-do 15355, Republic of Korea.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Brady', 'Affiliation': 'Department of Surgery - Otolaryngology, The University of Melbourne, Royal Victorian Eye and Ear Hospital, 32 Gisborne St RVEEH, Melbourne East 3002,Victoria, Australia.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Matthews', 'Affiliation': 'Department of Surgery - Otolaryngology, The University of Melbourne, Royal Victorian Eye and Ear Hospital, 32 Gisborne St RVEEH, Melbourne East 3002,Victoria, Australia.'}, {'ForeName': 'Katie Boncza', 'Initials': 'KB', 'LastName': 'Ozdowska', 'Affiliation': 'Department of Surgery - Otolaryngology, The University of Melbourne, Royal Victorian Eye and Ear Hospital, 32 Gisborne St RVEEH, Melbourne East 3002,Victoria, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Payne', 'Affiliation': 'Department of Surgery - Otolaryngology, The University of Melbourne, Royal Victorian Eye and Ear Hospital, 32 Gisborne St RVEEH, Melbourne East 3002,Victoria, Australia.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'McLean', 'Affiliation': 'Department of Surgery - Otolaryngology, The University of Melbourne, Royal Victorian Eye and Ear Hospital, 32 Gisborne St RVEEH, Melbourne East 3002,Victoria, Australia.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Rousset', 'Affiliation': 'Department of Surgery - Otolaryngology, The University of Melbourne, Royal Victorian Eye and Ear Hospital, 32 Gisborne St RVEEH, Melbourne East 3002,Victoria, Australia.'}, {'ForeName': 'Jonathon', 'Initials': 'J', 'LastName': 'Lo', 'Affiliation': 'Department of Surgery - Otolaryngology, The University of Melbourne, Royal Victorian Eye and Ear Hospital, 32 Gisborne St RVEEH, Melbourne East 3002,Victoria, Australia.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Creber', 'Affiliation': 'Department of Surgery - Otolaryngology, The University of Melbourne, Royal Victorian Eye and Ear Hospital, 32 Gisborne St RVEEH, Melbourne East 3002,Victoria, Australia.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Tari', 'Affiliation': 'Department of Surgery - Otolaryngology, The University of Melbourne, Royal Victorian Eye and Ear Hospital, 32 Gisborne St RVEEH, Melbourne East 3002,Victoria, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Dowell', 'Affiliation': 'Department of Surgery - Otolaryngology, The University of Melbourne, Royal Victorian Eye and Ear Hospital, 32 Gisborne St RVEEH, Melbourne East 3002,Victoria, Australia; Department of Audiology and Speech Sciences, University of Melbourne, 550 Swanston St, Carlton 3053, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Briggs', 'Affiliation': 'Department of Surgery - Otolaryngology, The University of Melbourne, Royal Victorian Eye and Ear Hospital, 32 Gisborne St RVEEH, Melbourne East 3002,Victoria, Australia; Cochlear Implant Clinic, Royal Victorian Eye and Ear Hospital, 32 Gisborne St, Melbourne East 3002, Australia.'}]",Hearing research,['10.1016/j.heares.2021.108224'] 2749,33774503,Structuralist mental representation of dual-action demands: Evidence for compositional coding from dual tasks with low cross-task dimensional overlap.,"The present study asks how behavioral (dual-action) demands in dual tasks are mentally represented and whether changes in representation might govern practice-related dual-task performance improvements. Three different representation accounts were empirically tested based on the idea that dual-action demands required in a dual-task trial might be represented in different ways. According to a compositional (Structuralist) account, component tasks remain structurally intact when combined with another task. In contrast, a holistic (Gestalt) account posits that dual-action requirements in dual tasks are represented holistically and entirely distinct from its component action requirements. Finally, a contextual change account assumes that a change in context (e.g., from single- to dual-action requirement) generally impedes response retrieval, similar to repeating a response while the task context switches. To address this issue, we analyzed trial-by-trial effects in a single/dual switch paradigm (SDS paradigm, involving a randomized mix of single- and dual-task trials within blocks). Specifically, we analyzed performance in an extensive dual-task training setting (involving training sessions across several days) combining an auditory-vocal task and a visual-manual task. The results indicated that, throughout practice, nearly all relevant comparisons of performance between complete switch trials (e.g., between the two single tasks) and partial repetition trials (e.g., from dual to single task) revealed partial repetition benefits, that is, for both the auditory-vocal and the visual-manual task, and for both single- and dual-task performance analyses. Therefore, dual-action requirements in the present dual-task setting are mentally represented in a compositional, Structuralist fashion, probably due to low between-task dimensional overlap.",2021,Three different representation accounts were empirically tested based on the idea that dual-action demands required in a dual-task trial might be represented in different ways.,[],"['dual switch paradigm (SDS paradigm', 'extensive dual-task training setting (involving training sessions across several days) combining an auditory-vocal task and a visual-manual task']",['partial repetition benefits'],[],"[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C3845714', 'cui_str': 'Several days'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}]",,0.0782191,Three different representation accounts were empirically tested based on the idea that dual-action demands required in a dual-task trial might be represented in different ways.,"[{'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Huestegge', 'Affiliation': 'University of Würzburg, Würzburg, Germany. Electronic address: lynn.huestegge@uni-wuerzburg.de.'}, {'ForeName': 'Tilo', 'Initials': 'T', 'LastName': 'Strobach', 'Affiliation': 'MSH Medical School, Hamburg, Germany.'}]",Acta psychologica,['10.1016/j.actpsy.2021.103298'] 2750,33823833,Designing and evaluation of E-health educational intervention on students' physical activity: an application of Pender's health promotion model.,"BACKGROUND The present study was conducted to design and evaluate the software and web-based curriculum based on Pender Model in order to promote students' physical activity. METHODS This is a quasi-experimental study conducted on 225 eligible students who were randomly divided into two groups of web and software-based intervention and control. The sample size of the study was selected using stratified sampling method. The evaluation was done with pre-test and post-test and follow-up, which were performed immediately two and six months following the intervention. The data were analyzed employing statistical software SPSS using descriptive statistics, chi-square, one way ANOVA, and repeated measures ANOVA. RESULTS The obtained results revealed that the level of physical activity after the intervention in the web and software groups significantly increased compared to the control group (p < 0.001). Moreover, the mean score of Pender model constructs, immediately two and six months after the intervention, was significantly different in the web and software groups (p < 0.001). CONCLUSION Our results indicated that, providing tailored message based on health promotion model's constructs has a positive effect on promoting physical activity of students. TRIAL REGISTRATION Name: Iranian Registry of Clinical Trials. Registration number: IRCT20181009041298N1 . Registration date: 2018-12-02 [retrospectively registered].",2021,The obtained results revealed that the level of physical activity after the intervention in the web and software groups significantly increased compared to the control group (p < 0.001).,"[""students' physical activity"", 'Registration number', 'Registration date: 2018-12-02 [retrospectively registered', '225 eligible students']",['E-health educational intervention'],"['level of physical activity', 'mean score of Pender model constructs']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C4517652', 'cui_str': '225'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}]",225.0,0.0128082,The obtained results revealed that the level of physical activity after the intervention in the web and software groups significantly increased compared to the control group (p < 0.001).,"[{'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Sabooteh', 'Affiliation': 'Student Research Committee, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Awat', 'Initials': 'A', 'LastName': 'Feizi', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Parivash', 'Initials': 'P', 'LastName': 'Shekarchizadeh', 'Affiliation': 'Department of General courses, School of Management and Medical Information Science, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Shahnazi', 'Affiliation': 'Department of Health Education and Promotion, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Firoozeh', 'Initials': 'F', 'LastName': 'Mostafavi', 'Affiliation': 'Department of Health Education and Promotion, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran. f_mostafavi@yahoo.com.'}]",BMC public health,['10.1186/s12889-021-10641-y'] 2751,33779417,Effect of educative reminder telephone calls on human papillomavirus immunization rate: A randomized controlled trial.,"CONTEXT Human papillomavirus coverage varies widely among women depending on their race, incomes, geographical location and education level. OBJECTIVE To evaluate whether reminder educative phone calls increase human papillomavirus vaccination rates in adult women aged 18-45 with high-risk factors of cervical cancer. DESIGN We conducted a single-blind randomized controlled trial in patients who consulted at a Canadian tertiary center in October 2019 during National Cervical Cancer Awareness Week. INTERVENTIONS We randomized women to receive three standardized educative phone calls or standard care. MAIN OUTCOME MEASURE We assessed the immunization rate at 6 months. RESULTS A total of 130 patients were randomized of which 62 patients were randomized to the intervention. Eight patients (15.4%) got immunized at 6 months in the intervention group as compared to seven (11.7%) in the control group (p = 0.5645). The main barrier to vaccination reported by non-immunized patients at 6 months was the cost of vaccination (42.3%). CONCLUSION Reminder educative phone calls did not increase human papillomavirus vaccination rates in adult women with risk factors of cervical cancer.ISRCTN registration number: ISRCTN58518971.",2021,"CONCLUSION Reminder educative phone calls did not increase human papillomavirus vaccination rates in adult women with risk factors of cervical cancer.","['human papillomavirus immunization rate', 'adult women aged 18-45 with high-risk factors of cervical cancer', 'patients who consulted at a Canadian tertiary center in October 2019 during National Cervical Cancer Awareness Week', '130 patients were randomized of which 62 patients', 'adult women with risk factors of cervical cancer']","['reminder educative phone calls', 'educative reminder telephone calls', 'standardized educative phone calls or standard care']","['human papillomavirus vaccination rates', 'papillomavirus vaccination rates', 'immunization rate', 'cost of vaccination']","[{'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C0030358', 'cui_str': 'Genus Papillomavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",62.0,0.328981,"CONCLUSION Reminder educative phone calls did not increase human papillomavirus vaccination rates in adult women with risk factors of cervical cancer.","[{'ForeName': 'Marie-Pier', 'Initials': 'MP', 'LastName': 'Bernard-Genest', 'Affiliation': 'Department of Obstetrics & Gynaecology, Division of Gynecologic Oncology, Université de Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ruel-Laliberté', 'Affiliation': 'Department of Obstetrics & Gynaecology, Division of Gynecologic Oncology, Université de Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'Korine', 'Initials': 'K', 'LastName': 'Lapointe-Milot', 'Affiliation': 'Department of Obstetrics & Gynaecology, Division of Gynecologic Oncology, Université de Sherbrooke, Sherbrooke, QC, Canada.'}]","Women's health (London, England)",['10.1177/17455065211003821'] 2752,33778124,Comparison of Anesthesia Results between Wide Awake Local Anesthesia no Tourniquet (WALANT) and Forearm Tourniquet Bier Block in Hand Surgeries: A Randomized Clinical Trial.,"Background There is still some debate regarding the most proper anesthetic technique in minor hand surgeries. We hypothesized that both the WALANT and forearm tourniquet Bier block methods provide effective anesthesia in minor hand surgeries without significant difference. Methods A total of 85 patients consented to participate in this study and were randomized into WALANT and single tourniquet forearm Bier block groups. In WALANT group, patients received adrenaline-contained lidocaine without tourniquet while lidocaine was administered accordingly after applying a forearm tourniquet in Bier group. Due to difference in intervention methods, the study was non-blinded. Need for additional analgesia during surgery, visual analogue scale (VAS) for pain intensity during operation and an hour later, amount of bleeding and active hand movements were evaluated and recorded. Results The need for analgesia and severity of pain (VAS) during surgery and one hour later were significantly less in WALANT group, whereas the amount of bleeding was less in Bier block group. The ability to move hand and fingers during the operation was the same in both groups. Conclusion Both WALANT and single cuff forearm tourniquet Bier block are effective methods in minor hand surgeries, however, forearm Bier block provides less analgesia and pain control with a drier field than WALANT method.",2021,"The need for analgesia and severity of pain (VAS) during surgery and one hour later were significantly less in WALANT group, whereas the amount of bleeding was less in Bier block group.","['Hand Surgeries', '85 patients consented to participate in this study and were randomized into WALANT and single tourniquet forearm Bier block groups']","['adrenaline-contained lidocaine', 'lidocaine']","['visual analogue scale (VAS) for pain intensity', 'amount of bleeding', 'analgesia and severity of pain (VAS']","[{'cui': 'C0187067', 'cui_str': 'Operative procedure on hand'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0580806', 'cui_str': 'Local anesthetic intravenous regional block'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",85.0,0.0771874,"The need for analgesia and severity of pain (VAS) during surgery and one hour later were significantly less in WALANT group, whereas the amount of bleeding was less in Bier block group.","[{'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Farzam', 'Affiliation': 'Department of Orthopedy, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Deilami', 'Affiliation': 'Department of Anesthesiology, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Jalili', 'Affiliation': 'Department of Anesthesiology, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Koorosh', 'Initials': 'K', 'LastName': 'Kamali', 'Affiliation': 'Department of Public Health, School of Public Health, Zanjan University of Medical Sciences, Zanjan, Iran.'}]",The archives of bone and joint surgery,['10.22038/abjs.2020.49526.2487'] 2753,33778117,Computed Tomography and Magnetic Resonance Imaging are Similarly Reliable in the Assessment of Glenohumeral Arthritis and Glenoid Version.,"Background The purpose of this study was to compare the intraobserver and interobserver reliability of CT and T2-weighted MRI for evaluation of the severity of glenoid wear, glenohumeral subluxation, and glenoid version. Methods Sixty-one shoulders with primary osteoarthritis had CT and MRI scans before shoulder arthroplasty. All slices were blinded and randomized before evaluation. Two fellowship-trained shoulder surgeons and three orthopaedic surgery trainees reviewed the images to classify glenoid wear (Walch and Mayo classifications) and glenohumeral subluxation (Mayo classification). Glenoid version was measured using Friedman's technique. After a minimum two-week interval, the process was repeated. Results Intraobserver reliability was good for the CT group and fair-to-good for the MRI group for the Walch, Mayo glenoid, and Mayo subluxation classifications; interobserver reliability was poor for the CT and fair-to-poor for the MRI group. For the measurement of glenoid version, intraobserver reliability was good for the CT and substantial for the MRI group; interobserver agreement was good for both groups. There were no significant differences in reliability between staff surgeons and trainees for any of the classifications or measurements. Conclusion CT and MRI appear similarly reliable for the classification of glenohumeral wear patterns. For the measurement of glenoid version, MRI was slightly more reliable than CT within observers. Differences in training level did not produce substantial differences in agreement, suggesting these systems can be applied by observers of different experience levels with similar reliability.",2021,"Intraobserver reliability was good for the CT group and fair-to-good for the MRI group for the Walch, Mayo glenoid, and Mayo subluxation classifications; interobserver reliability was poor for the CT and fair-to-poor for the MRI group.","['Two fellowship-trained shoulder surgeons and three orthopaedic surgery trainees', 'Methods\n\n\nSixty-one shoulders with primary osteoarthritis had CT and MRI scans before shoulder arthroplasty']","['Computed Tomography and Magnetic Resonance Imaging', 'CT']","['Glenoid version', 'Intraobserver reliability']","[{'cui': 'C0015770', 'cui_str': 'Fellowships'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0409952', 'cui_str': 'Idiopathic osteoarthritis'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0186662', 'cui_str': 'Arthroplasty of shoulder'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}]",61.0,0.0579013,"Intraobserver reliability was good for the CT group and fair-to-good for the MRI group for the Walch, Mayo glenoid, and Mayo subluxation classifications; interobserver reliability was poor for the CT and fair-to-poor for the MRI group.","[{'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Hopkins', 'Affiliation': 'University of Tennessee-Campbell Clinic Department of Orthopaedic Surgery and Biomedical Engineering, Memphis, Tennessee, USA.'}, {'ForeName': 'Frederick M', 'Initials': 'FM', 'LastName': 'Azar', 'Affiliation': 'University of Tennessee-Campbell Clinic Department of Orthopaedic Surgery and Biomedical Engineering, Memphis, Tennessee, USA.'}, {'ForeName': 'Ryan P', 'Initials': 'RP', 'LastName': 'Mulligan', 'Affiliation': 'Duke University Medical School, Department of Orthopaedic Surgery, Durham, North Carolina, USA.'}, {'ForeName': 'Anthony M', 'Initials': 'AM', 'LastName': 'Hollins', 'Affiliation': 'Memphis Shoulder and Orthopaedic Surgery, Memphis, Tennessee, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Smith', 'Affiliation': 'University of Tennessee-Campbell Clinic Department of Orthopaedic Surgery and Biomedical Engineering, Memphis, Tennessee, USA.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Throckmorton', 'Affiliation': 'University of Tennessee-Campbell Clinic Department of Orthopaedic Surgery and Biomedical Engineering, Memphis, Tennessee, USA.'}]",The archives of bone and joint surgery,['10.22038/abjs.2020.38922.2035'] 2754,33823815,Effect of low-concentration carbohydrate on patient-centered quality of recovery in patients undergoing thyroidectomy: a prospective randomized trial.,"BACKROUND At present, low-concentration carbohydrate is rarely used in minor trauma surgery, and its clinical efficacy is unknown. The aim of the study was to evaluate the effect of preoperative oral low-concentration carbohydrate on patient-centered quality of recovery in patients undergoing thyroidectomy using Quality of Recovery - 15 (QoR-15) questionnaire. METHODS One hundred twenty patients were randomized to oral intake of 300 ml carbohydrate solution (CH group) or 300 ml pure water (PW group) 2 h before surgery or fasting for 8 h before surgery (F group). The QoR-15 questionnaire was administered to compare the quality of recovery at 1d before surgery (T0), 24 h, 48 h, 72 h after surgery (T1, T2, T3), and perioperative blood glucose was recorded. RESULTS Compared to the F group, the QoR-15 scores were statistically higher in the CH and PW group at T1 (P < 0.05), and the enhancement of recovery quality reached the clinical significance at T1 in the CH group compared with the F group. Among the five dimensions of the QoR-15 questionnaire, physical comfort, physiological support and emotional dimension in the CH group were significantly better than the F group (P < 0.05) at T1. Besides, blood glucose of CH group was significantly lower than the PW group and F group at each time point after surgery. CONCLUSIONS Low-concentration carbohydrate could decrease the incidence of postoperative hyperglycemia and improve the patient-centered quality of recovery on patients undergoing open thyroidectomy at the early stage postoperatively. TRIAL REGISTRATION ChiCTR1900024731 . Date of registration: 25/07/2019.",2021,"Compared to the F group, the QoR-15 scores were statistically higher in the CH and PW group at T1 (P ","['patients undergoing thyroidectomy using Quality of Recovery -\u200915 (QoR-15) questionnaire', 'One hundred twenty patients', 'patients undergoing thyroidectomy']","['low-concentration carbohydrate', 'preoperative oral low-concentration carbohydrate', '300\u2009ml carbohydrate solution (CH group) or 300\u2009ml pure water (PW group) 2\u2009h before surgery or fasting for 8\u2009h before surgery']","['QoR-15 questionnaire, physical comfort, physiological support and emotional dimension', 'QoR-15 scores', 'perioperative blood glucose', 'blood glucose', 'postoperative hyperglycemia', 'enhancement of recovery quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",120.0,0.0685627,"Compared to the F group, the QoR-15 scores were statistically higher in the CH and PW group at T1 (P ","[{'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of North Sichuan Medical College, Nanchong, 637000, Sichuan, China.'}, {'ForeName': 'Peng-Fei', 'Initials': 'PF', 'LastName': 'Gao', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of North Sichuan Medical College, Nanchong, 637000, Sichuan, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of North Sichuan Medical College, Nanchong, 637000, Sichuan, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of North Sichuan Medical College, Nanchong, 637000, Sichuan, China.'}, {'ForeName': 'Yun-Feng', 'Initials': 'YF', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of North Sichuan Medical College, Nanchong, 637000, Sichuan, China.'}, {'ForeName': 'Guo-Qiang', 'Initials': 'GQ', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of North Sichuan Medical College, Nanchong, 637000, Sichuan, China.'}, {'ForeName': 'Jing-Yan', 'Initials': 'JY', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of North Sichuan Medical College, Nanchong, 637000, Sichuan, China. 419931094@qq.com.'}]",BMC anesthesiology,['10.1186/s12871-021-01323-8'] 2755,33823786,"Analgesic efficacy of postoperative bilateral, ultrasound-guided, posterior transversus abdominis plane block for laparoscopic colorectal cancer surgery: a randomized, prospective, controlled study.","BACKGROUND We assessed whether a postoperative bilateral, ultrasound-guided, posterior transversus abdominis plane (TAP) block could reduce 24 h rescue tramadol requirement compared with placebo in patients undergoing elective laparoscopic colorectal cancer surgery. METHODS Patients scheduled to undergo elective laparoscopic surgery following the diagnosis of colorectal cancer were included in this study and randomized into Group and Group Control. The patients received a postoperative bilateral, ultrasound-guided, posterior TAP block in either 20 mL of 0.5% ropivacaine (Group TAP) per side or an equivalent volume of normal saline (Group Control). The primary outcome was the cumulative consumption of rescue tramadol within 24 h after the surgery. Secondary endpoints included (1) resting and movement numerical rating scale (NRS) pain scores at 2, 4, 6, 12, 24, 48, and 72 h; (2) incidences of related side effects; (3) time to the first request for rescue tramadol; (4) patient satisfaction regarding postoperative analgesia; (5) time to restoration of intestinal function; (6) time to mobilization; and (7) the length of hospital stay. RESULTS In total, 92 patients were randomized, and 82 patients completed the analysis. The total rescue tramadol requirement (median [interquartile range]) within the first 24 h was lower in Group TAP (0 [0, 87.5] mg) than in Group Control (100 [100, 200] mg), P < 0.001. The posterior TAP block reduced resting and movement NRS pain scores at 2, 4, 6, 12, and 24 h after surgery (all P < 0.001) but showed similar scores at 48 h or 72 h. A higher level of satisfaction with postoperative analgesia was observed in Group TAP on day 1 (P = 0.002), which was similar on days 2 (P = 0.702) and 3 (P = 0.551), compared with the Group Control. A few incidences of opioid-related side effects (P < 0.001) and a lower percentage of patients requiring rescue tramadol analgesia within 24 h (P < 0.001) were observed in Group TAP. The time to the first request for rescue analgesia was prolonged, and the time to mobilization and flatus was reduced with a shorter hospital stay in Group TAP as compared with Group Control. CONCLUSIONS A postoperative bilateral, ultrasound-guided, posterior TAP block resulted in better pain management and a faster recovery in patients undergoing laparoscopic colorectal cancer surgery, without adverse effects. TRIAL REGISTRATION The study was registered at http://www.chictr.org.cn ( ChiCTR-IPR-17012650 ; Sep 12, 2017).",2021,"A higher level of satisfaction with postoperative analgesia was observed in Group TAP on day 1 (P = 0.002), which was similar on days 2 (P = 0.702) and 3 (P = 0.551), compared with the Group Control.","['92 patients were randomized, and 82 patients completed the analysis', 'laparoscopic colorectal cancer surgery', 'Patients scheduled to undergo elective laparoscopic surgery following the diagnosis of colorectal cancer', 'patients undergoing elective laparoscopic colorectal cancer surgery', 'patients undergoing laparoscopic colorectal cancer surgery']","['ultrasound-guided, posterior TAP block', 'postoperative bilateral, ultrasound-guided, posterior transversus abdominis plane (TAP) block', 'postoperative bilateral, ultrasound-guided, posterior transversus abdominis plane block', 'placebo', 'postoperative bilateral, ultrasound-guided, posterior TAP block in either 20\u2009mL of 0.5% ropivacaine (Group TAP) per side or an equivalent volume of normal saline']","['level of satisfaction with postoperative analgesia', 'time to mobilization and flatus', 'Analgesic efficacy', 'cumulative consumption of rescue tramadol', '1) resting and movement numerical rating scale (NRS) pain scores', 'posterior TAP block reduced resting and movement NRS pain scores', 'pain management', '72\u2009h; (2) incidences of related side effects; (3) time to the first request for rescue tramadol; (4) patient satisfaction regarding postoperative analgesia; (5) time to restoration of intestinal function; (6) time to mobilization; and (7) the length of hospital stay', 'hospital stay', 'total rescue tramadol requirement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0686900', 'cui_str': 'Request for'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",92.0,0.316651,"A higher level of satisfaction with postoperative analgesia was observed in Group TAP on day 1 (P = 0.002), which was similar on days 2 (P = 0.702) and 3 (P = 0.551), compared with the Group Control.","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of North Sichuan Medical College, Nanchong, Sichuan, China.'}, {'ForeName': 'Han-Ying', 'Initials': 'HY', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Pidu District People's Hospital, 156# East Street, Pitong Town, Pidu District, Chengdu, Sichuan, 611730, People's Republic of China.""}, {'ForeName': 'Zong-Yi', 'Initials': 'ZY', 'LastName': 'Yuan', 'Affiliation': 'Departments of Oral and Maxillofacial, Nanchong Central Hospital, The Second Clinical Medical College, North Sichuan Medical College (University), Nanchong, Sichuan, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of North Sichuan Medical College, Nanchong, Sichuan, China.'}, {'ForeName': 'Yi-Rong', 'Initials': 'YR', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, China.'}, {'ForeName': 'Qi-Lin', 'Initials': 'QL', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of North Sichuan Medical College, Nanchong, Sichuan, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, West China Hospital of Sichuan University, Chengdu, 610041, Sichuan, P. R. China. 739501155@qq.com.'}]",BMC anesthesiology,['10.1186/s12871-021-01317-6'] 2756,33795024,"Self-management advice, exercise and foot orthoses for plantar heel pain: the TREADON pilot and feasibility randomised trial.","BACKGROUND Plantar heel pain (PHP) is common and impacts negatively on physical function and quality of life. Initial treatment usually comprises analgesia and self-management advice (SMA), with referral to a physiotherapist or podiatrist recommended only when symptoms persist. Systematic reviews highlight limitations of existing evidence for the effectiveness of exercises and orthoses. The objective of the TREADON pilot and feasibility trial was to inform the design of a future main trial to compare the clinical and cost-effectiveness of self-management advice (SMA), individualised exercises and foot orthoses for PHP. METHODS This was a four-arm randomised feasibility and pilot trial with 12-week follow-up. Adults aged ≥ 18 years with PHP were identified from primary care by general practice consultation, retrospective general practice medical record review or a population survey. Participants were randomised to either (i) SMA, (ii) SMA plus individualised exercises (SMA-exercises), (iii) SMA plus prefabricated foot orthoses (SMA-orthoses) or (iv) SMA plus combined individualised exercises and prefabricated foot orthoses (SMA-combined). Feasibility outcomes were recruitment; retention; intervention adherence, credibility and satisfaction; performance of three potential primary outcome measures (pain numeric rating scale (NRS), Foot Function Index-pain subscale (FFI-pain), Manchester Foot Pain and Disability Index-pain subscale (MFPDI-pain)); and parameters for informing the main trial sample size calculation. RESULTS Eighty-two participants were recruited. All three identification methods met the target number of participants. Retention at 12 weeks was 67%. All interventions were successfully delivered as per protocol. Adherence (range over 12 weeks 64-100%) and credibility (93%) were highest in the SMA-combined arm. Satisfaction with treatment was higher for the three clinician-supported interventions (SMA 29%, SMA-exercises 72%, SMA-orthoses 71%, SMA-combined 73%). Responsiveness (baseline to 12 weeks) was higher for FFI-pain (standardised response mean 0.96) and pain NRS (1.04) than MFPDI-pain (0.57). Conservative sample size parameter estimates for standard deviation were pain NRS 2.5, FFI-pain 25 and MFPDI-pain 4, and baseline-outcome correlations were 0.5-0.6, 0.4 and < 0.3, respectively. CONCLUSIONS We demonstrated the feasibility of conducting a future main randomised clinical trial comparing the clinical and cost-effectiveness of SMA, exercises and/or foot orthoses for PHP. TRIAL REGISTRATION NUMBER ISRCTN 12160508 . Prospectively registered 5 th July 2016.",2021,"Satisfaction with treatment was higher for the three clinician-supported interventions (SMA 29%, SMA-exercises 72%, SMA-orthoses 71%, SMA-combined 73%).","['Adults aged ≥\u200918 years with PHP were identified from primary care by general practice consultation, retrospective general practice medical record review or a population survey', 'plantar heel pain', 'Eighty-two participants were recruited']","['analgesia and self-management advice (SMA', 'self-management advice (SMA), individualised exercises and foot orthoses', 'SMA, (ii) SMA plus individualised exercises (SMA-exercises), (iii) SMA plus prefabricated foot orthoses (SMA-orthoses) or (iv) SMA plus combined individualised exercises and prefabricated foot orthoses', 'SMA, exercises and/or foot orthoses', 'Self-management advice, exercise and foot orthoses']","['retention; intervention adherence, credibility and satisfaction; performance of three potential primary outcome measures (pain numeric rating scale (NRS), Foot Function Index-pain subscale (FFI-pain), Manchester Foot Pain and Disability Index-pain subscale (MFPDI-pain)); and parameters for informing the main trial sample size calculation', 'Adherence', 'pain NRS', 'FFI-pain', 'credibility', 'physical function and quality of life', 'Satisfaction']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231786', 'cui_str': 'Plantar heel pain'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0730229', 'cui_str': 'Medical records review'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C3816958', 'cui_str': '80'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4706287', 'cui_str': 'Foot Function Index'}, {'cui': 'C0206042', 'cui_str': 'Fatal familial insomnia'}, {'cui': 'C2960415', 'cui_str': 'Manchester foot pain and disability index'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C1441506', 'cui_str': 'Calculation technique'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",82.0,0.294446,"Satisfaction with treatment was higher for the three clinician-supported interventions (SMA 29%, SMA-exercises 72%, SMA-orthoses 71%, SMA-combined 73%).","[{'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'Chesterton', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Thomas', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Hendry', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, G4 0BA, UK.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Goddin', 'Affiliation': 'Keele Clinical Trials Unit, David Weatherall Building, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Halliday', 'Affiliation': 'Keele Clinical Trials Unit, David Weatherall Building, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Lawton', 'Affiliation': 'Keele Clinical Trials Unit, David Weatherall Building, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Lewis', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'Christian D', 'Initials': 'CD', 'LastName': 'Mallen', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'Hylton B', 'Initials': 'HB', 'LastName': 'Menz', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'Nadine E', 'Initials': 'NE', 'LastName': 'Foster', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Roddy', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, Staffordshire, ST5 5BG, UK. e.roddy@keele.ac.uk.'}]",Pilot and feasibility studies,['10.1186/s40814-021-00808-0'] 2757,33794205,"Avelumab plus standard-of-care chemoradiotherapy versus chemoradiotherapy alone in patients with locally advanced squamous cell carcinoma of the head and neck: a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial.","BACKGROUND Chemoradiotherapy is the standard of care for unresected locally advanced squamous cell carcinoma of the head and neck. We aimed to assess if addition of avelumab (anti-PD-L1) to chemoradiotherapy could improve treatment outcomes for this patient population. METHODS In this randomised, double-blind, placebo-controlled, phase 3 study, patients were recruited from 196 hospitals and cancer treatment centres in 22 countries. Patients aged 18 years or older, with histologically confirmed, previously untreated, locally advanced squamous cell carcinoma of the oropharynx, hypopharynx, larynx, or oral cavity (unselected for PD-L1 status), an Eastern Cooperative Oncology Group performance status score of 0 or 1, and who could receive chemoradiotherapy were eligible. Patients were randomly assigned (1:1) centrally by means of stratified block randomisation with block size four (stratified by human papillomavirus status, tumour stage, and nodal stage, and done by an interactive response technology system) to receive 10 mg/kg avelumab intravenously every 2 weeks plus chemoradiotherapy (100 mg/m 2 cisplatin every 3 weeks plus intensity-modulated radiotherapy with standard fractionation of 70 Gy [35 fractions during 7 weeks]; avelumab group) or placebo plus chemoradiotherapy (placebo group). This was preceded by a single 10 mg/kg avelumab or placebo lead-in dose given 7 days previously and followed by 10 mg/kg avelumab or placebo every 2 weeks maintenance therapy for up to 12 months. The primary endpoint was progression-free survival by investigator assessment per modified Response Evaluation Criteria in Solid Tumors, version 1.1, in all randomly assigned patients. Adverse events were assessed in patients who received at least one dose of avelumab or placebo. This trial is registered with ClinicalTrials.gov, NCT02952586. Enrolment is no longer ongoing, and the trial has been discontinued. FINDINGS Between Dec 12, 2016, and Jan 29, 2019, from 907 patients screened, 697 patients were randomly assigned to the avelumab group (n=350) or the placebo group (n=347). Median follow-up for progression-free survival was 14·6 months (IQR 8·5-19·6) in the avelumab group and 14·8 months (11·6-18·8) in the placebo group. Median progression-free survival was not reached (95% CI 16·9 months-not estimable) in the avelumab group and not reached (23·0 months-not estimable) in the placebo group (stratified hazard ratio 1·21 [95% CI 0·93-1·57] favouring the placebo group; one-sided p=0·92). The most common grade 3 or worse treatment-related adverse events were neutropenia (57 [16%] of 348 patients in the avelumab group vs 52 [15%] of 344 patients in the placebo group), mucosal inflammation (50 [14%] vs 45 [13%]), dysphagia (49 [14%] vs 47 [14%]), and anaemia (41 [12%] vs 44 [13%]). Serious treatment-related adverse events occurred in 124 (36%) patients in the avelumab group and in 109 (32%) patients in the placebo group. Treatment-related deaths occurred in two (1%) patients in the avelumab group (due to general disorders and site conditions, and vascular rupture) and one (<1%) in the placebo group (due to acute respiratory failure). INTERPRETATION The primary objective of prolonging progression-free survival with avelumab plus chemoradiotherapy followed by avelumab maintenance in patients with locally advanced squamous cell carcinoma of the head and neck was not met. These findings may help inform the design of future trials investigating the combination of immune checkpoint inhibitors plus CRT. FUNDING Pfizer and Merck KGaA, Darmstadt, Germany.",2021,Median progression-free survival was not reached (95% CI 16·9 months-not estimable) in the avelumab group and not reached (23·0 months-not estimable) in the placebo group (stratified hazard ratio 1·21 [95% CI 0·93-1·57] favouring the placebo group; one-sided p=0·92).,"['patients with locally advanced squamous cell carcinoma of the head and neck', 'Between Dec 12, 2016, and Jan 29, 2019, from 907 patients screened, 697 patients', 'patients were recruited from 196 hospitals and cancer treatment centres in 22 countries', 'patients with locally advanced squamous cell carcinoma of the head and neck was not met', 'Patients aged 18 years or older, with histologically confirmed, previously untreated, locally advanced squamous cell carcinoma of the oropharynx, hypopharynx, larynx, or oral cavity (unselected for PD-L1 status), an Eastern Cooperative Oncology Group performance status score of 0 or 1, and who could receive chemoradiotherapy were eligible', 'unresected locally advanced squamous cell carcinoma of the head and neck']","['avelumab or placebo lead-in dose given 7 days previously and followed by 10 mg/kg avelumab or placebo', 'avelumab plus chemoradiotherapy', 'Avelumab plus standard-of-care chemoradiotherapy versus chemoradiotherapy alone', 'avelumab or placebo', 'chemoradiotherapy (100 mg/m 2 cisplatin every 3 weeks plus intensity-modulated radiotherapy with standard fractionation of 70 Gy [35 fractions during 7 weeks]; avelumab group) or placebo plus chemoradiotherapy (placebo', 'avelumab (anti-PD-L1) to chemoradiotherapy', 'placebo', 'avelumab', 'Chemoradiotherapy']","['Median progression-free survival', 'dysphagia', 'anaemia', 'Adverse events', 'Median follow-up for progression-free survival', 'mucosal inflammation', 'adverse events', 'deaths', 'neutropenia', 'progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0280313', 'cui_str': 'Squamous cell carcinoma of oropharynx'}, {'cui': 'C0020629', 'cui_str': 'Hypopharyngeal structure'}, {'cui': 'C0023051', 'cui_str': 'Disorder of the larynx'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C4055417', 'cui_str': 'avelumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0524811', 'cui_str': 'Dose Fractionation, Radiotherapy'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}]",697.0,0.793647,Median progression-free survival was not reached (95% CI 16·9 months-not estimable) in the avelumab group and not reached (23·0 months-not estimable) in the placebo group (stratified hazard ratio 1·21 [95% CI 0·93-1·57] favouring the placebo group; one-sided p=0·92).,"[{'ForeName': 'Nancy Y', 'Initials': 'NY', 'LastName': 'Lee', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA. Electronic address: leen2@mskcc.org.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Ferris', 'Affiliation': 'UPMC Hillman Cancer Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Psyrri', 'Affiliation': 'Attikon University Hospital, National Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Robert I', 'Initials': 'RI', 'LastName': 'Haddad', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Tahara', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bourhis', 'Affiliation': 'Centre Hospitalier Universitaire Vaudois, Lausanne, Vaud, Switzerland.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Harrington', 'Affiliation': 'The Royal Marsden Hospital-The Institute of Cancer Research National Institute for Health Research Biomedical Research Centre, London, UK.'}, {'ForeName': 'Peter Mu-Hsin', 'Initials': 'PM', 'LastName': 'Chang', 'Affiliation': 'Taipei Veterans General Hospital, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Jin-Ching', 'Initials': 'JC', 'LastName': 'Lin', 'Affiliation': 'Department of Radiation Oncology, Changhua Christian Hospital, Changhua, Taiwan.'}, {'ForeName': 'Mohammad Abdul', 'Initials': 'MA', 'LastName': 'Razaq', 'Affiliation': 'Stephenson Cancer Center, University of Oklahoma, Oklahoma, OK, USA.'}, {'ForeName': 'Maria Margarida', 'Initials': 'MM', 'LastName': 'Teixeira', 'Affiliation': 'Instituto Português de Oncologia de Coimbra Francisco Gentil, EPE, Coimbra, Portugal.'}, {'ForeName': 'József', 'Initials': 'J', 'LastName': 'Lövey', 'Affiliation': 'Országos Onkológiai Intézet, Sugárterápiás Osztály Semmelweis Egyetem, Onkológiai Tanszék, Budapest, Hungary.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Chamois', 'Affiliation': 'Centre Hospitalier Prive Saint Gregoire, Saint Gregoire, France.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Rueda', 'Affiliation': 'Medical Oncology, Costa del Sol Sanitary Agency and Regional University Hospital, IBIMA, Málaga, Spain.'}, {'ForeName': 'Chaosu', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Fudan University Cancer Hospital, Xuhui, Shanghai, China.'}, {'ForeName': 'Lara A', 'Initials': 'LA', 'LastName': 'Dunn', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Mikhail Vladimirovich', 'Initials': 'MV', 'LastName': 'Dvorkin', 'Affiliation': 'Budgetary Institution of Healthcare of the Omsk Region, Clinical Oncology Dispensary, Omsk, Russia.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'De Beukelaer', 'Affiliation': 'Pfizer, Zürich, Switzerland.'}, {'ForeName': 'Dmitri', 'Initials': 'D', 'LastName': 'Pavlov', 'Affiliation': 'Pfizer, La Jolla, CA, USA.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thurm', 'Affiliation': 'Pfizer, La Jolla, CA, USA.'}, {'ForeName': 'Ezra', 'Initials': 'E', 'LastName': 'Cohen', 'Affiliation': 'Moores Cancer Center, UC San Diego Health, La Jolla, CA, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30737-3'] 2758,33794005,"One year of Football Fitness improves L1-L4 BMD, postural balance, and muscle strength in women treated for breast cancer.","PURPOSE To examine efficacy of 12 months Football Fitness offered twice per week on bone mineral density (BMD), bone turnover markers (BTM), postural balance, muscle strength, and body composition in women treated for early-stage breast cancer (BC). METHODS Women treated for early-stage BC were randomized to Football Fitness (FFG, n = 46) or control (CON, n = 22) in a 2:1 ratio for 12 months, with assessments performed at baseline, 6 months and 12 months. Outcomes were total body-, lumbar spine- and proximal femur BMD, total body lean and fat mass, leg muscle strength, postural balance, and plasma amino-terminal propeptide of type 1 procollagen (P1NP), osteocalcin, and C-terminal telopeptide of type 1 collagen (CTX). Intention-to-treat (ITT) analyses and per-protocol analyses (≥50% attendance in FFG) were performed using linear mixed models. RESULTS Participants in FFG completing the 12-month intervention (n = 33) attended 0.8 (SD = 0.4) sessions per week. Intention to treat analysis of mean changes over 12 months showed significant differences (p<.05) in L1-L4 BMD (0.029 g/cm 2 , 95%CI: 0.001 to 0.057), leg press strength (7.2 kg, 95%CI: 0.1 to 14.3), and postural balance (-4.3 n need of support, 95%CI: -8.0 to -0.7) favoring FFG compared to CON. In the per-protocol analyses, L1-L4 and trochanter major BMD were improved (p = .012 and .030, respectively) in FFG compared with CON. No differences were observed between groups in BTMs in the ITT or per protocol analyses. CONCLUSION One year of Football Fitness training may improve L1-L4 BMD, leg muscle strength, and postural balance in women treated for early-stage breast cancer.",2021,"One year of Football Fitness training may improve L1-L4 BMD, leg muscle strength and postural balance in women treated for early-stage breast cancer.","['women treated for early-stage breast cancer', 'Women treated for early-stage BC', 'women treated for breast cancer', 'women treated for early-stage breast cancer (BC']","['Football Fitness training', '95%CI', 'Football Fitness (FFG, n=46) or control (CON']","['leg press strength', 'L1-L4 BMD, leg muscle strength and postural balance', 'total body-, lumbar spine- and proximal femur BMD, total body lean and fat mass, leg muscle strength, postural balance, and plasma amino-terminal propeptide of type 1 procollagen (P1NP), osteocalcin and C-terminal telopeptide of type 1 collagen (CTX', 'postural balance ', 'bone mineral density (BMD), bone turnover markers (BTM), postural balance, muscle strength and body composition', 'L1-L4 BMD', 'L1-L4 and trochanter major BMD', 'L1-L4 BMD, postural balance and muscle strength']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0224456', 'cui_str': 'Skeletal muscle structure of lower leg'}, {'cui': 'C1256755', 'cui_str': 'Postural balance'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",,0.138903,"One year of Football Fitness training may improve L1-L4 BMD, leg muscle strength and postural balance in women treated for early-stage breast cancer.","[{'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Uth', 'Affiliation': 'University Hospitals Centre for Health Research, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Fristrup', 'Affiliation': 'Section of Sport and Health Sciences, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Sørensen', 'Affiliation': 'University Hospitals Centre for Health Research, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Eva Wulff', 'Initials': 'EW', 'LastName': 'Helge', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Maja Kjaergaard', 'Initials': 'MK', 'LastName': 'Christensen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Julie Boye', 'Initials': 'JB', 'LastName': 'Kjaergaard', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Trine Kjeldgaard', 'Initials': 'TK', 'LastName': 'Møller', 'Affiliation': 'Section of Sport and Health Sciences, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Jørn Wulff', 'Initials': 'JW', 'LastName': 'Helge', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Niklas Rye', 'Initials': 'NR', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Clinical Biochemistry, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Rørth', 'Affiliation': 'Department of Clinical Epidemiology, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Eva Soelberg', 'Initials': 'ES', 'LastName': 'Vadstrup', 'Affiliation': 'Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Krustrup', 'Affiliation': 'Section of Sport and Health Sciences, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13963'] 2759,33797501,Temporal profile of the pro- and anti-inflammatory responses to severe hemorrhage in patients with venous thromboembolism: Findings from the PROPPR trial.,"BACKGROUND The Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) trial showed that 15% of patients developed venous thromboembolism (VTE) following hemorrhage, but the mechanisms are unknown. Since inflammation is associated with hypercoagulability and thrombosis, our goal was to compare the temporal inflammatory profile following hemorrhagic shock in patients with and without VTE. STUDY DESIGN Secondary analysis was performed on data collected from PROPPR. Blood samples collected at 0, 2, 4, 6, 12, 24, 48 and 72 hours following admission were assayed on a 27-target cytokine panel, and compared between VTE (n=83) and non-VTE (n=475) patients. p<0.05 indicated significance. RESULTS Over time, both groups exhibited elevations in pro-inflammatory mediators interleukin (IL)-6, IL-8, IL-10, granulocyte colony-stimulating (G-CSF) 57, monocyte chemoattractant protein (MCP)-1 and macrophage inflammatory protein (MIP)-1β, and anti-inflammatory mediators IL-1ra and IL-10 (P<0.05 vs admission). VTE patients showed amplified responses for IL-6 (6-72 hours) and IL-8 (6-24 hours), which peaked at later time points, and GCSF-57 (12-24 hours), MCP-1 (6-72 hours), and MIP-1β (2-12 hours) (P<0.05 vs non-VTE per time point) that peaked at similar time points to non-VTE patients. The anti-inflammatory responses were similar between groups, but the interleukin-mediated pro-inflammatory responses continued to rise after the peak anti-inflammatory response in the VTE group. The occurrence rate of adverse events was higher in VTE (97%) versus non-VTE (87%, p=0.009) and was associated with higher inflammation. CONCLUSION Patients with VTE following hemorrhagic shock exhibited a prolonged and amplified pro-inflammatory responses mediated by select interleukin, chemotactic, and glycoprotein cytokines that are not antagonized by anti-inflammatory mediators. This response is not related to randomization group, injury severity or degree of shock, but may be linked to adverse events. LEVEL OF EVIDENCE Prognostic, Level III.",2021,VTE patients showed amplified responses for IL-6 (6-72 hours) and IL-8,"['patients with and without VTE', 'patients with venous thromboembolism']",['VTE'],"['venous thromboembolism (VTE', 'pro-inflammatory mediators interleukin (IL)-6, IL-8, IL-10, granulocyte colony-stimulating (G-CSF) 57, monocyte chemoattractant protein (MCP)-1 and macrophage inflammatory protein (MIP)-1β, and anti-inflammatory mediators IL-1ra and IL-10', 'occurrence rate of adverse events', 'IL-8', 'anti-inflammatory responses']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}]","[{'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}]","[{'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0018183', 'cui_str': 'Granulocyte'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}, {'cui': 'C0282566', 'cui_str': 'Monocyte Chemotactic Proteins'}, {'cui': 'C0376579', 'cui_str': 'Macrophage Inflammatory Proteins'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",475.0,0.21612,VTE patients showed amplified responses for IL-6 (6-72 hours) and IL-8,"[{'ForeName': 'Belinda H', 'Initials': 'BH', 'LastName': 'McCully', 'Affiliation': 'Division of Trauma, Critical Care & Acute Care Surgery, Department of Surgery, Oregon Health & Science University, Portland OR Center for Translational Injury Research, Division of Acute Care Surgery, Department of Surgery, University of Texas Health Science Center, Houston, TX Divison of Acute Care Surgery, Department of Surgery, University of Southern California, Los Angeles, CA Department of Surgery, Denver Health Medical Center and the University of Colorado; Denver, CO Department of Surgery, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Charlie E', 'Initials': 'CE', 'LastName': 'Wade', 'Affiliation': ''}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Fox', 'Affiliation': ''}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Inaba', 'Affiliation': ''}, {'ForeName': 'Mitchell J', 'Initials': 'MJ', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Holcomb', 'Affiliation': ''}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Schreiber', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000003088'] 2760,33797494,A quasi-experimental study of targeted normoxia in critically ill trauma patients.,"BACKGROUND Avoidance of hypoxia and hyperoxia may reduce morbidity and mortality in critically ill civilian and military trauma patients. The objective of this study is to determine if a multimodal quality improvement intervention increases adherence to a consensus-based, targeted normoxia strategy. We hypothesized that this intervention would safely improve compliance with targeted normoxia. METHODS This is a pre/post quasi-experimental pilot study to improve adherence to normoxia, defined as a pulse oximetry (SpO2) of 90-96% or an arterial partial pressure oxygen (PaO2) of 60-100mmHg. We used a multimodal informatics and educational intervention guiding clinicians to safely titrate supplemental oxygen to normoxia based on SpO2 monitoring in critically ill trauma patients admitted to the surgical-trauma or neurosurgical intensive care unit within 24 hours of emergency department arrival. The primary outcome was effectiveness in delivering targeted normoxia (i.e., an increase in the probability of being in the targeted normoxia range and/or a reduction in the probability of being on a higher FiO2). RESULTS Analysis included 371 pre-intervention subjects and 201 post-intervention subjects. Pre-and post-intervention subjects were of similar age, race/ethnicity, and gender and had similar comorbidities and APACHE II scores. Overall, the adjusted probability of being hyperoxic while on supplemental oxygen was reduced during the post-intervention period (adjusted odds ratio (aOR) 0.74, 95% confidence interval (CI) 0.57-0.97). There was a higher probability of being on room air (fraction inspired oxygen concentration (FiO2)=0.21) in the post-intervention period (aOR 1.38, 95%CI 0.83-2.30). Additionally, there was a decreased amount of patient time spent on higher levels of FiO2 (FiO2 >40%) without a concomitant increase in hypoxia. CONCLUSIONS A multimodal intervention targeting normoxia in critically ill trauma patients increased normoxia and lowered the use of supplemental oxygen. A large clinical trial is needed to validate the impact of this protocol on patient-centered clinical outcomes. LEVEL OF EVIDENCE Therapeutic/Care Management, level II.",2021,"Overall, the adjusted probability of being hyperoxic while on supplemental oxygen was reduced during the post-intervention period (adjusted odds ratio (aOR) 0.74, 95% confidence interval (CI) 0.57-0.97).","['Analysis included 371 pre-intervention subjects and 201 post-intervention subjects', 'critically ill civilian and military trauma patients', 'critically ill trauma patients admitted to the surgical-trauma or neurosurgical intensive care unit within 24 hours of emergency department arrival', 'critically ill trauma patients']",['multimodal informatics and educational intervention guiding clinicians to safely titrate supplemental oxygen to normoxia based on SpO2 monitoring'],"['probability of being in the targeted normoxia range and/or a reduction in the probability of being on a higher FiO2', 'effectiveness in delivering targeted normoxia', 'adjusted probability of being hyperoxic while on supplemental oxygen', 'hypoxia', 'morbidity and mortality', 'higher probability of being on room air (fraction inspired oxygen concentration', 'patient time spent on higher levels of FiO2']","[{'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]","[{'cui': 'C0599807', 'cui_str': 'Informatics'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0513686', 'cui_str': 'Pulse oximetry monitoring'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0428648', 'cui_str': 'Inspired oxygen concentration'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",371.0,0.0817454,"Overall, the adjusted probability of being hyperoxic while on supplemental oxygen was reduced during the post-intervention period (adjusted odds ratio (aOR) 0.74, 95% confidence interval (CI) 0.57-0.97).","[{'ForeName': 'Layne', 'Initials': 'L', 'LastName': 'Dylla', 'Affiliation': 'Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, CO Department of Anesthesiology, University of Colorado School of Medicine, Aurora, CO Department of Biostatistics and Informatics, Colorado School of Public Health, Aurora, CO US Army Institute of Surgical Research, JBSA Fort Sam, Houston, TX US Air Force 59th Medical Wing, Office of the Chief Scientist, JBSA, Lackland, TX Department of Emergency Medicine, Brooke Army Medical Center, San Antonio, TX Department of Surgery, University of Colorado School of Medicine, Aurora, CO Center for COMBAT Research, Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Anderson', 'Affiliation': ''}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Douin', 'Affiliation': ''}, {'ForeName': 'Conner L', 'Initials': 'CL', 'LastName': 'Jackson', 'Affiliation': ''}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Rice', 'Affiliation': ''}, {'ForeName': 'Maj Steven G', 'Initials': 'MSG', 'LastName': 'Schauer', 'Affiliation': ''}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Neumann', 'Affiliation': ''}, {'ForeName': 'Col Vikhyat S', 'Initials': 'CVS', 'LastName': 'Bebarta', 'Affiliation': ''}, {'ForeName': 'Franklin L', 'Initials': 'FL', 'LastName': 'Wright', 'Affiliation': ''}, {'ForeName': 'Adit A', 'Initials': 'AA', 'LastName': 'Ginde', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000003177'] 2761,33797490,Resolution of Organ Dysfunction as a Predictor of Long-Term Survival in Necrotizing Soft Tissue Infections: Analysis of the ACCUTE Trial and a Retrospective Claims-Linked Database Study.,"BACKGROUND Necrotizing soft tissue infections (NSTI) are an acute surgical condition with high morbidity and mortality. Timely identification, resuscitation and aggressive surgical management has significantly decreased inpatient mortality. However, reduced inpatient mortality has shifted the burden of disease to long-term mortality associated with persistent organ dysfunction. METHODS We performed a combined analysis of NSTI patients from the ACCUTE randomized-controlled interventional trial (ATB-202) and comprehensive administrative database (ATB-204) in order to determine the association of persistent organ dysfunction on inpatient and long-term outcomes. Persistent organ dysfunction was defined as a modified SOFA (mSOFA) score ≥2 at Day 14 (D14) after NSTI diagnosis, and resolution of organ dysfunction defined as mSOFA <1. RESULTS The analysis included 506 hospitalized NSTI patients requiring surgical debridement, including 247 from ATB-202, and 259 from ATB-204. In both study cohorts, age and comorbidity burden were higher in the D14 mSOFA ≥2 group. Patients with D14 mSOFA ≤1 had significantly lower 90-day mortality than those with mSOFA ≥2 in both ATB-202 (2.4% vs 21.5%; p<0.001) and ATB-204 (6% vs 16%: p=0.008) studies. Additionally, in an adjusted covariate analysis of the combined study datasets D14 mSOFA ≤1 was an independent predictor of lower 90-day mortality (OR 0.26, 95% CI 0.13-0.53; p=0.001). In both studies, D14 mSOFA ≤1 was associated with more favorable discharge status and decreased resource utilization. CONCLUSION For patients with NSTI undergoing surgical management, persistent organ dysfunction at 14 days, strongly predicts higher resource utilization, poor discharge disposition, and higher long-term mortality. Promoting the resolution of acute organ dysfunction after NSTI should be considered as a target for investigational therapies to improve long-term outcomes after NSTI. LEVEL OF EVIDENCE Prognostic/epidemiology study, Level III.",2021,"CONCLUSION For patients with NSTI undergoing surgical management, persistent organ dysfunction at 14 days, strongly predicts higher resource utilization, poor discharge disposition, and higher long-term mortality.","['506 hospitalized NSTI patients requiring surgical debridement, including 247 from ATB-202, and 259 from ATB-204']",[],"['favorable discharge status and decreased resource utilization', 'Persistent organ dysfunction', 'Resolution of Organ Dysfunction', 'resource utilization, poor discharge disposition, and higher long-term mortality', '90-day mortality', 'inpatient mortality']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0149778', 'cui_str': 'Soft tissue infection'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0048072', 'cui_str': '4-anisyltetrazolium blue'}]",[],"[{'cui': 'C0586514', 'cui_str': 'Discharge status'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}]",506.0,0.0619901,"CONCLUSION For patients with NSTI undergoing surgical management, persistent organ dysfunction at 14 days, strongly predicts higher resource utilization, poor discharge disposition, and higher long-term mortality.","[{'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Brakenridge', 'Affiliation': 'From the Department of Surgery (S.C.B), University of Florida College of Medicine, Gainesville Florida; Atox Bio, Ltd (D.A.W, W.M.D), Durham, North Carolina; Biomedical Statistical Consulting (G.M.), Wynnewood, Pennsylvania; Health Economics and Outcomes Research, Optum (K.E.A., V.W.), Eden Prairie, Minnesota; Division of Acute Care Surgery (A.K.M.), Atrium Health, Charlotte, North Carolina; Department of Surgery (E.M.B) University of Washington, Harborview Medical Center, Seattle, Washington.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Wilfret', 'Affiliation': ''}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Maislin', 'Affiliation': ''}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Andrade', 'Affiliation': ''}, {'ForeName': 'Valery', 'Initials': 'V', 'LastName': 'Walker', 'Affiliation': ''}, {'ForeName': 'Addison K', 'Initials': 'AK', 'LastName': 'May', 'Affiliation': ''}, {'ForeName': 'Wayne M', 'Initials': 'WM', 'LastName': 'Dankner', 'Affiliation': ''}, {'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': 'Bulger', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000003183'] 2762,33797489,Can Educational Videos Reduce Opioid Consumption in Trauma Inpatients? A Cluster-Randomized Pilot Study.,"BACKGROUND Opioids are often used to treat pain after traumatic injury, but patient education on safe use of opioids is not standard. To address this gap, we created a video-based opioid education program for patients. We hypothesized that video viewing would lead to a decrease in overall opioid use and morphine equivalent doses (MEDs) on their penultimate hospital day. Our secondary aim was to study barriers to video implementation. METHODS We performed a prospective pragmatic cluster randomized pilot study of video education for trauma floor patients. One of two equivalent trauma floors was selected as the intervention group; patients were equally likely to be admitted to either floor. Nursing staff were to show videos to English-speaking or Spanish-literate patients within one day of floor arrival, excluding patients with GCS < 15. Opioid use and MEDs taken on the day before discharge were compared. Intention to treat (ITT, intervention vs. control) and per-protocol groups (PP, video viewers vs. non-viewers) were compared, alpha=0.05. Protocol compliance was also assessed. RESULTS In ITT analysis, there was no difference in percent of patients using opioids or MEDs on the day before discharge. In PP analysis, there was no different in percent of patients using opioids on the day before discharge. However, video-viewers still on opioids took significantly fewer MEDs than patients who did not see the video (26 vs 38, p<0.05). Protocol compliance was poor; only 46% of the intervention group saw the videos. CONCLUSIONS Video-based education did not reduce inpatient opioid consumption, although there may be benefits in specific subgroups. Implementation was hindered by staffing and workflow limitations, and staff bias may have limited the effect of randomization. We must continue to establish effective methods to educate patients about safe pain management and translate these into standard practices. LEVEL OF EVIDENCE Level IV, therapeutic.",2021,"In ITT analysis, there was no difference in percent of patients using opioids or MEDs on the day before discharge.","['trauma floor patients', 'Trauma Inpatients', 'patients']",['video education'],[],"[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",[],,0.0201442,"In ITT analysis, there was no difference in percent of patients using opioids or MEDs on the day before discharge.","[{'ForeName': 'Esther S', 'Initials': 'ES', 'LastName': 'Tseng', 'Affiliation': 'Division of Trauma, Critical Care, Burns, and Emergency General Surgery, MetroHealth Medical Center, Department of Surgery, Case Western Reserve University School of Medicine, Cleveland, OH Department of Surgery, Cleveland Clinic, Cleveland, OH Department of Surgery, Cleveland Clinic South Pointe Hospital, Warrensville, OH Department of Population and Quantitative Health Sciences, Case Western Reserve University School of Medicine, Cleveland, OH.'}, {'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'Zolin', 'Affiliation': ''}, {'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Young', 'Affiliation': ''}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Claridge', 'Affiliation': ''}, {'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'Conrad-Schnetz', 'Affiliation': ''}, {'ForeName': 'Eric T', 'Initials': 'ET', 'LastName': 'Curfman', 'Affiliation': ''}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Wise', 'Affiliation': ''}, {'ForeName': 'Vetrica C', 'Initials': 'VC', 'LastName': 'Lemaitre', 'Affiliation': ''}, {'ForeName': 'Vanessa P', 'Initials': 'VP', 'LastName': 'Ho', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000003174'] 2763,33799833,8-Week Supplementation of 2S-Hesperidin Modulates Antioxidant and Inflammatory Status after Exercise until Exhaustion in Amateur Cyclists.,"Both acute and chronic ingestion of 2S-hesperidin have shown antioxidant and anti-inflammatory effects in animal studies, but so far, no one has studied this effect of chronic ingestion in humans. The main objective was to evaluate whether an 8-week intake of 2S-hesperidin had the ability to modulate antioxidant-oxidant and inflammatory status in amateur cyclists. A parallel, randomized, double-blind, placebo-controlled trial study was carried out with two groups (500 mg/d 2S-hesperidin; n = 20 and 500 mg/d placebo; n = 20). An incremental test was performed to determine the working zones in a rectangular test, which was used to analyze for changes in antioxidant and inflammatory biomarkers. After 2S-hesperidin ingestion, we found in the rectangular test: (1) an increase in superoxide dismutase (SOD) after the exercise phase until exhaustion ( p = 0.045) and the acute recovery phase ( p = 0.004), (2) a decrease in the area under the oxidized glutathione curve (GSSG) ( p = 0.016), and (3) a decrease in monocyte chemoattractant protein 1 (MCP1) after the acute recovery phase ( p = 0.004), post-intervention. Chronic 2S-hesperidin supplementation increased endogenous antioxidant capacity (↑SOD) after maximal effort and decreased oxidative stress (↓AUC-GSSG) during the rectangular test, decreasing inflammation (↓MCP1) after the acute recovery phase.",2021,"Chronic 2S-hesperidin supplementation increased endogenous antioxidant capacity (↑SOD) after maximal effort and decreased oxidative stress (↓AUC-GSSG) during the rectangular test, decreasing inflammation (↓MCP1) after the acute recovery phase.","['amateur cyclists', 'Amateur Cyclists']","['placebo', '2S-hesperidin; n = 20 and 500 mg/d placebo', 'Chronic 2S-hesperidin supplementation', '2S-Hesperidin']","['monocyte chemoattractant protein 1 (MCP1', 'area under the oxidized glutathione curve (GSSG', 'oxidative stress (↓AUC-GSSG', 'superoxide dismutase (SOD', 'endogenous antioxidant capacity (↑SOD']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0019392', 'cui_str': 'Hesperidin'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0061516', 'cui_str': 'Glutathione Disulfide'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}]",,0.278509,"Chronic 2S-hesperidin supplementation increased endogenous antioxidant capacity (↑SOD) after maximal effort and decreased oxidative stress (↓AUC-GSSG) during the rectangular test, decreasing inflammation (↓MCP1) after the acute recovery phase.","[{'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Martínez-Noguera', 'Affiliation': 'Research Center for High Performance Sport, Catholic University of Murcia, Campus de los Jerónimos Nº 135, UCAM, 30107 Murcia, Spain.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Marín-Pagán', 'Affiliation': 'Research Center for High Performance Sport, Catholic University of Murcia, Campus de los Jerónimos Nº 135, UCAM, 30107 Murcia, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Carlos-Vivas', 'Affiliation': 'Health, Economy, Motricity and Education Research Group (HEME), Faculty of Sport Sciences, University of Extremadura, Avda. de Elvas, s/n., 06006 Badajoz, Spain.'}, {'ForeName': 'Pedro E', 'Initials': 'PE', 'LastName': 'Alcaraz', 'Affiliation': 'Research Center for High Performance Sport, Catholic University of Murcia, Campus de los Jerónimos Nº 135, UCAM, 30107 Murcia, Spain.'}]","Antioxidants (Basel, Switzerland)",['10.3390/antiox10030432'] 2764,33799800,Perseverative Cognition and Snack Choice: An Online Pilot Investigation.,"Perseverative cognition (PC), consisting of worry and rumination, has been consistently linked to a variety of poorer health outcomes, namely via the worsening of stress-induced health risk behaviours. However, research into PC and unhealthy food choice, a key health behaviour, still remains relatively unexplored. In the current pilot investigation, 284 participants were recruited to take part in an online food choice paradigm before completing the Perseverative Thinking Questionnaire (PTQ) and the Brief State Rumination Inventory (BSRI). As a reduced availability of unhealthy snacks has been shown to improve snack choice, participants were randomly allocated to either an even condition (a 3:3 ratio of ≤99 kcal and ≥199 kcal snacks) or an uneven condition (a 4:2 ratio in favour of ≤99 kcal snacks). It was hypothesized that higher levels of PC may predict greater instances of poorer snack choices across, or even within, this paradigm. Despite an increase availability of lower calorie snacks leading to a healthier snack choice, both state and trait PC measures did not significantly influence snack choice irrespective of this varying availability. Although, marginal trends were found for higher state PC and higher calorie crisp selections. The current pilot therefore adds to the growing literature advocating for the use of behavioural economic tactics to engender healthier food choices, yet further work is needed to unpick the mediating role of PC (and its components) in snack consumption paradigms.",2021,"Despite an increase availability of lower calorie snacks leading to a healthier snack choice, both state and trait PC measures did not significantly influence snack choice irrespective of this varying availability.",['284 participants were recruited to take part in an online food choice paradigm before completing the'],[],"['Perseverative Thinking Questionnaire (PTQ) and the Brief State Rumination Inventory (BSRI', 'Perseverative Cognition and Snack Choice']","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",[],"[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]",284.0,0.0507857,"Despite an increase availability of lower calorie snacks leading to a healthier snack choice, both state and trait PC measures did not significantly influence snack choice irrespective of this varying availability.","[{'ForeName': 'Timothy M', 'Initials': 'TM', 'LastName': 'Eschle', 'Affiliation': 'Psychology Department, School of Education and Social Sciences, University of the West of Scotland, Paisley PA1 2BE, UK.'}, {'ForeName': 'Dane', 'Initials': 'D', 'LastName': 'McCarrick', 'Affiliation': 'School of Psychology, Faculty of Medicine and Health, University of Leeds, Leeds LS2 9JT, UK.'}]","Behavioral sciences (Basel, Switzerland)",['10.3390/bs11030033'] 2765,33799774,Effect of Integrated Neuromuscular Exercise in Physical Education Class on Health-Related Fitness in Female Children.,"Integrated neuromuscular training (INT) showed benefits for improving fundamental movement skills (FMS). However, the INT health-related fitness (HRF) effects are lacking. The current study aimed to determine the effects of INT implemented during physical education (PE) in a primary school in the Republic of Serbia on HRF in female children. The sample consisted of 72 healthy girls who were divided into the intervention (EG: n = 37; mean ± SD: age = 8.17 ± 0.31) and control (CG: n = 35; age = 8.11 ± 0.31) groups. The EG and CG performed the INT program and traditional PE activities two times per week within the first ~15 min of PE class, respectively. The Fitnessgram battery tests assessed the HRF (body composition, cardiorespiratory endurance, muscular fitness, and flexibility) before and after the program. After eight weeks, the EG significantly reduced all fat measures, while the CG decreased only triceps skinfold but to a smaller extent ( F = 5.92, p < 0.02, ŋ 2 = 0.09). Both groups significantly improved the performance of almost all muscular fitness tests (curl-ups, trunk lift, push-ups); however, the EG increased the push-ups more than the CG ( F = 9.01, p < 0.01, ŋ 2 = 0.14). The EG additionally improved the modified pull-ups ( F = 14.09, p < 0.01, ŋ 2 = 0.19) and flexed arm hang ( F = 28.82, p < 0.01, ŋ 2 = 0.33) tests. The flexibility and cardiorespiratory endurance of both groups did not significantly change after eight weeks. This approach of exercise showed positive acceptance and relatively good results after only eight weeks.",2021,"Both groups significantly improved the performance of almost all muscular fitness tests (curl-ups, trunk lift, push-ups); however, the EG increased the push-ups more than the CG ( F = 9.01, p < 0.01, ŋ 2 = 0.14).","['72 healthy girls who were divided into the intervention (EG: n = 37; mean ± SD: age = 8.17 ± 0.31) and control (CG: n = 35; age = 8.11 ± 0.31) groups', 'primary school in the Republic of Serbia on HRF in female children', 'Female Children']","['Integrated neuromuscular training (INT', 'Integrated Neuromuscular Exercise', 'INT implemented during physical education (PE']","['flexibility and cardiorespiratory endurance', 'CG decreased only triceps skinfold', 'performance of almost all muscular fitness tests (curl-ups, trunk lift, push-ups', 'HRF (body composition, cardiorespiratory endurance, muscular fitness, and flexibility', 'INT health-related fitness (HRF) effects', 'modified pull-ups']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517447', 'cui_str': '0.31'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0026510', 'cui_str': 'Montenegro'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0870604', 'cui_str': 'Female child'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0010474', 'cui_str': ""Curling's ulcers""}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}]",72.0,0.00933846,"Both groups significantly improved the performance of almost all muscular fitness tests (curl-ups, trunk lift, push-ups); however, the EG increased the push-ups more than the CG ( F = 9.01, p < 0.01, ŋ 2 = 0.14).","[{'ForeName': 'Marijana', 'Initials': 'M', 'LastName': 'Sinđić', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Draženka', 'Initials': 'D', 'LastName': 'Mačak', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Todorović', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Bianka', 'Initials': 'B', 'LastName': 'Purda', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Batez', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare9030312'] 2766,33798214,The emotion storyboard: A method to examine social judgments of emotion.,"As perceivers, we need to understand context to make social judgments about emotion, such as judging whether emotion is appropriate. We propose a graphic novel-like method, the emotion storyboard, for use in research on social judgments of emotion. Across two studies, participants were randomly assigned to read emotion storyboards or written vignettes to compare the efficacy of the emotion storyboard to that of vignettes in studies on social judgments of emotion. In Study 1, undergraduates (N = 194) answered comprehension questions and rated story clarity and immersion. Participants also made social judgments of emotion by rating main character emotion control and appropriateness of intensity. To further compare the efficacy of the methods, in Study 2, Amazon Mechanical Turk workers (N = 213) answered comprehension questions while response times were recorded, rated clarity, answered a race manipulation check, and rated main character emotion type appropriateness. Overall, emotion storyboards resulted in greater clarity ratings, greater race manipulation check accuracy, and in some instances, enhanced comprehension and comprehension response times relative to vignettes. In emotion storyboards, main character emotion was rated more controlled and more appropriate in intensity, but not different in emotion type appropriateness, than in vignettes. Overall, the method offers a new method of examining social elements of emotion that enhances comprehension and maximizes experimental efficiency.",2021,"Overall, emotion storyboards resulted in greater clarity ratings, greater race manipulation check accuracy, and in some instances, enhanced comprehension and comprehension response times relative to vignettes.","['Study 2, Amazon Mechanical Turk workers (N = 213']",['read emotion storyboards or written vignettes'],"['clarity ratings, greater race manipulation check accuracy, and in some instances, enhanced comprehension and comprehension response times relative to vignettes', 'comprehension questions and rated story clarity and immersion', 'social judgments of emotion by rating main character emotion control and appropriateness of intensity']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0337911', 'cui_str': 'Turks'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0043266', 'cui_str': 'Writing'}]","[{'cui': 'C0486588', 'cui_str': 'Clarity (property)'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0007952', 'cui_str': 'Character'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",213.0,0.0330772,"Overall, emotion storyboards resulted in greater clarity ratings, greater race manipulation check accuracy, and in some instances, enhanced comprehension and comprehension response times relative to vignettes.","[{'ForeName': 'Kaitlin', 'Initials': 'K', 'LastName': 'McCormick-Huhn', 'Affiliation': 'William S. Boyd School of Law, University of Nevada, Las Vegas, Las Vegas, Nevada, United States of America.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Shields', 'Affiliation': 'Department of Psychology, The Pennsylvania State University, University Park, Pennsylvania, United States of America.'}]",PloS one,['10.1371/journal.pone.0249294'] 2767,33773988,The effect of a quality improvement intervention on sleep and delirium in critically ill patients in a surgical intensive care unit.,"BACKGROUND Delirium is a deleterious condition affecting up to 60% of patients in the surgical intensive care unit (SICU). Few SICU-focused delirium interventions have been implemented, including those addressing sleep-wake disruption, a modifiable delirium risk factor common in critically ill patients. RESEARCH QUESTION What is the effect on delirium and sleep quality of a multicomponent non-pharmacological intervention aimed at improving sleep-wake disruption in patients in the SICU setting? STUDY DESIGN AND METHODS Using a staggered pre-post design, we implemented a quality improvement intervention in two SICUs (general surgery/trauma and cardiovascular) in an academic medical center. After a pre-intervention (baseline) period, a multicomponent unit-wide nighttime (i.e., efforts to minimize unnecessary sound and light, provision of earplugs and eye masks) and daytime (i.e., raising blinds, promotion of physical activity) intervention bundle was implemented. A daily checklist was used to prompt staff to complete intervention bundle elements. Delirium was evaluated twice-daily using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Patient sleep quality ratings were evaluated daily using the Richards-Campbell Sleep Questionnaire (RCSQ). RESULTS Six hundred and forty-six SICU admissions (332 baseline, 314 intervention) were analyzed. Median [IQR) age was 61 [49, 70] years with 35% females and 83% white race. During the intervention period, patients experienced fewer days of delirium (proportion [±SD] of intensive care unit days = 15% [±27]) as compared to the pre-intervention period (20% [±31]; p=0.022), with an adjusted pre-post decrease of 4.9% [95% CI, 0.5-9.2%], p=0.03). Overall RCSQ perceived sleep quality ratings did not change, but the RCSQ noise subscore increased (9.5% [95% CI, 1.1-17.5%], p=0.02). INTERPRETATION Our multicomponent intervention was associated with a significant reduction in the proportion of days patients experienced delirium, reinforcing the feasibility and effectiveness of a non-pharmacological sleep-wake bundle to reduce delirium in critically ill patients in the SICU.",2021,"Overall RCSQ perceived sleep quality ratings did not change, but the RCSQ noise subscore increased (9.5% [95% CI, 1.1-17.5%], p=0.02). ","['patients in the SICU setting', 'Six hundred and forty-six', 'critically ill patients', 'patients in the surgical intensive care unit (SICU', 'two SICUs (general surgery/trauma and cardiovascular) in an academic medical center', 'Median [IQR) age was 61 [49, 70] years with 35% females and 83% white race', 'critically ill patients in a surgical intensive care unit']",['quality improvement intervention'],"['RCSQ noise subscore', 'sleep and delirium', 'Campbell Sleep Questionnaire (RCSQ', 'Patient sleep quality ratings', 'Delirium', 'Overall RCSQ perceived sleep quality ratings']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1690590', 'cui_str': 'Surgical intensive care unit'}, {'cui': 'C4708790', 'cui_str': '640'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C1274039', 'cui_str': 'General surgery'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.0198121,"Overall RCSQ perceived sleep quality ratings did not change, but the RCSQ noise subscore increased (9.5% [95% CI, 1.1-17.5%], p=0.02). ","[{'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Tonna', 'Affiliation': 'Division of Cardiothoracic Surgery, Department of Surgery, University of Utah Health, Salt Lake City, UT, USA; Division of Emergency Medicine, Department of Surgery, University of Utah Health, Salt Lake City, UT, USA. Electronic address: joseph.tonna@hsc.utah.edu.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Dalton', 'Affiliation': 'Division of Cardiothoracic Surgery, Department of Surgery, University of Utah Health, Salt Lake City, UT, USA.'}, {'ForeName': 'Angela P', 'Initials': 'AP', 'LastName': 'Presson', 'Affiliation': 'Division of Epidemiology, Department of Medicine, University of Utah Health, Salt Lake City, UT, USA.'}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Division of Epidemiology, Department of Medicine, University of Utah Health, Salt Lake City, UT, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Colantuoni', 'Affiliation': 'Outcomes After Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, MD, USA; Department of Biostatistics, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Lander', 'Affiliation': 'Cardiovascular Intensive Care Unit, University of Utah Health, Salt Lake City, UT, USA.'}, {'ForeName': 'Sullivan', 'Initials': 'S', 'LastName': 'Howard', 'Affiliation': 'Surgical Intensive Care Unit, University of Utah Health, Salt Lake City, UT, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Beynon', 'Affiliation': 'Critical Care, AirMed & Emergency Nursing, University of Utah Health, Salt Lake City, UT, USA.'}, {'ForeName': 'Biren B', 'Initials': 'BB', 'LastName': 'Kamdar', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, UC San Diego School of Medicine, La Jolla, CA, USA.'}]",Chest,['10.1016/j.chest.2021.03.030'] 2768,33779741,Assessment of Diagnosis and Triage in Validated Case Vignettes Among Nonphysicians Before and After Internet Search.,"Importance When confronted with new medical symptoms, many people turn to the internet to understand why they are ill as well as whether and where they should get care. Such searches may be harmful because they may facilitate misdiagnosis and inappropriate triage. Objective To empirically measure the association of an internet search for health information with diagnosis, triage, and anxiety by laypeople. Design, Setting, and Participants This survey study used a nationally representative sample of US adults who were recruited through an online platform between April 1, 2019, and April 15, 2019. A total of 48 validated case vignettes of both common (eg, viral illness) and severe (eg, heart attack) conditions were used. Participants were asked to relay their diagnosis, triage, and anxiety regarding 1 of these cases before and after searching the internet for health information. Exposures Short, validated case vignettes written at or below the sixth-grade reading level randomly assigned to participants. Main Outcomes and Measures Correct diagnosis, correct triage, and flipping (changing) or anchoring (not changing) diagnosis and triage decisions were the main outcomes. Multivariable modeling was performed to identify patient factors associated with correct triage and diagnosis. Results Of the 5000 participants, 2549 were female (51.0%), 3819 were White (76.4%), and the mean (SD) age was 45.0 (16.9) years. Mean internet search time was 12.1 (95% CI, 10.7-13.5) minutes per case. No difference in triage accuracy was found before and after search (74.5% vs 74.1%; difference, -0.4 [95% CI, -1.4 to 0.6]; P = .06), but improved diagnostic accuracy was found (49.8% vs 54.0%; difference, 4.2% [95% CI, 3.1%-5.3%]; P < .001). Most participants (4254 [85.1%]) were anchored on their diagnosis. Of the 14.9% of participants (n = 746) who flipped their diagnosis, 9.6% (n = 478) flipped from incorrect to correct and 5.4% (n = 268) flipped from correct to incorrect. The following groups had an increased rate of correct diagnosis: adults 40 years or older (eg, 40-49 years: 5.1 [95% CI, 0.8-9.4] percentage points better than those aged <30 years; P = .02), women (9.4 [95% CI, 6.8-12.0] percentage points better than men; P < .001), and those with perceived poor health status (16.3 [95% CI, 6.9-25.6] percentage points better than those with excellent status; P = .001) and with more than 2 chronic diseases (6.8 [95% CI, 1.5-12.1] percentage points better than those with 0 conditions; P = .01). Conclusions and Relevance This study found that an internet search for health information was associated with small increases in diagnostic accuracy but not with triage accuracy.",2021,This study found that an internet search for health information was associated with small increases in diagnostic accuracy but not with triage accuracy.,"['5000 participants, 2549 were female (51.0%), 3819 were White (76.4%), and the mean (SD) age was 45.0 (16.9) years', 'nationally representative sample of US adults who were recruited through an online platform between April 1, 2019, and April 15, 2019', 'A total of 48 validated case vignettes of both common (eg, viral illness) and severe (eg, heart attack) conditions', 'adults 40 years or older']",[],"['poor health status', 'triage accuracy', 'Measures\n\n\nCorrect diagnosis, correct triage, and flipping (changing) or anchoring (not changing) diagnosis and triage decisions', 'diagnostic accuracy', 'Mean internet search time', 'chronic diseases', 'rate of correct diagnosis']","[{'cui': 'C4319610', 'cui_str': '5000'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],"[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0540654', 'cui_str': 'Casper Protein'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}]",5000.0,0.297766,This study found that an internet search for health information was associated with small increases in diagnostic accuracy but not with triage accuracy.,"[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Levine', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Ateev', 'Initials': 'A', 'LastName': 'Mehrotra', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}]",JAMA network open,['10.1001/jamanetworkopen.2021.3287'] 2769,33779716,Randomized comparison of the clinical Outcome of single versus Multiple Arterial grafts: Quality of Life (ROMA:QOL) - Rationale and Study Protocol.,"The objective of the Randomized comparison of the Outcome of single vs Multiple Arterial grafts: Quality of Life (ROMA:QOL) trial is to evaluate the impact of coronary artery bypass graft surgery (CABG) on quality of life (QOL). The primary hypothesis of ROMA:QOL is that participants in the multiple arterial group (MAG) will report time-varying changes in QOL that will be lower in the post-operative recovery period and higher after 12 months compared to patients in the single arterial group (SAG). The secondary hypotheses are that both groups will have improvements in symptoms at 12 months, and that compared to the SAG group, participants in the MAG group will experience better physical functioning and physical and mental health symptoms. An estimated 2,111 participants will be enrolled from the parent ROMA trial from 13 countries. Outcome assessments include the Seattle Angina Questionnaire (SAQ) (primary outcome), Short Form-12v2, EQ-5D-5L, PROMIS-29 and PROMIS Neuropathic Pain measured at baseline, first post-operative visit, 6, 12, 24, 36, 48 and 60- months. The analysis for the primary outcome, the change in the SAQ from baseline to 12- months, will be compared across all time-points between the two treatment arms. The ROMA:QOL trial will answer whether there are differences in QOL, physical and mental health symptoms overall for CABG, by MAG and SAG intervention arms, by sex, and between patients with and without diabetes.",2021,"QOL trial will answer whether there are differences in QOL, physical and mental health symptoms overall for CABG, by MAG and SAG intervention arms, by sex, and between patients with and without diabetes.","['2,111 participants will be enrolled from the parent ROMA trial from 13 countries']","['coronary artery bypass graft surgery (CABG', 'ROMA', 'single versus Multiple Arterial grafts: Quality of Life', 'MAG', 'single vs Multiple Arterial grafts: Quality of Life (ROMA:QOL', 'SAG']","['physical functioning and physical and mental health symptoms', 'quality of life (QOL', 'Seattle Angina Questionnaire (SAQ) (primary outcome), Short Form-12v2, EQ-5D-5L, PROMIS-29 and PROMIS Neuropathic Pain', 'QOL, physical and mental health symptoms overall for CABG']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0018422', 'cui_str': 'Gypsies'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0018422', 'cui_str': 'Gypsies'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0450140', 'cui_str': 'Arterial graft'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]",2111.0,0.173671,"QOL trial will answer whether there are differences in QOL, physical and mental health symptoms overall for CABG, by MAG and SAG intervention arms, by sex, and between patients with and without diabetes.","[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Masterson Creber', 'Affiliation': 'Department of Population Health Sciences, Division of Health Informatics, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Safford', 'Affiliation': 'Department of Medicine, Division of General Internal Medicine, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Ballman', 'Affiliation': 'Department of Population Health Sciences, Division of Health Informatics, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Myers', 'Affiliation': 'Department of Population Health Sciences, Division of Health Informatics, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Fremes', 'Affiliation': 'Schulich Heart Centre, Sunnybrook Health Science, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Gaudino', 'Affiliation': 'Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York, NY, USA.'}]",European heart journal. Quality of care & clinical outcomes,['10.1093/ehjqcco/qcab022'] 2770,33779698,Ponesimod Compared With Teriflunomide in Patients With Relapsing Multiple Sclerosis in the Active-Comparator Phase 3 OPTIMUM Study: A Randomized Clinical Trial.,"Importance To our knowledge, the Oral Ponesimod Versus Teriflunomide In Relapsing Multiple Sclerosis (OPTIMUM) trial is the first phase 3 study comparing 2 oral disease-modifying therapies for relapsing multiple sclerosis (RMS). Objective To compare the efficacy of ponesimod, a selective sphingosine-1-phosphate receptor 1 (S1P1) modulator with teriflunomide, a pyrimidine synthesis inhibitor, approved for the treatment of patients with RMS. Design, Setting, and Participants This multicenter, double-blind, active-comparator, superiority randomized clinical trial enrolled patients from April 27, 2015, to May 16, 2019, who were aged 18 to 55 years and had been diagnosed with multiple sclerosis per 2010 McDonald criteria, with a relapsing course from the onset, Expanded Disability Status Scale (EDSS) scores of 0 to 5.5, and recent clinical or magnetic resonance imaging disease activity. Interventions Patients were randomized (1:1) to 20 mg of ponesimod or 14 mg of teriflunomide once daily and the placebo for 108 weeks, with a 14-day gradual up-titration of ponesimod starting at 2 mg to mitigate first-dose cardiac effects of S1P1 modulators and a follow-up period of 30 days. Main Outcomes and Measures The primary end point was the annualized relapse rate. The secondary end points were the changes in symptom domain of Fatigue Symptom and Impact Questionnaire-Relapsing Multiple Sclerosis (FSIQ-RMS) at week 108, the number of combined unique active lesions per year on magnetic resonance imaging, and time to 12-week and 24-week confirmed disability accumulation. Safety and tolerability were assessed. Exploratory end points included the percentage change in brain volume and no evidence of disease activity (NEDA-3 and NEDA-4) status. Results For 1133 patients (567 receiving ponesimod and 566 receiving teriflunomide; median [range], 37.0 [18-55] years; 735 women [64.9%]), the relative rate reduction for ponesimod vs teriflunomide in the annualized relapse rate was 30.5% (0.202 vs 0.290; P < .001); the mean difference in FSIQ-RMS, -3.57 (-0.01 vs 3.56; P < .001); the relative risk reduction in combined unique active lesions per year, 56% (1.405 vs 3.164; P < .001); and the reduction in time to 12-week and 24-week confirmed disability accumulation risk estimates, 17% (10.1% vs 12.4%; P = .29) and 16% (8.1% vs 9.9; P = .37), respectively. Brain volume loss at week 108 was lower by 0.34% (-0.91% vs -1.25%; P < .001); the odds ratio for NEDA-3 achievement was 1.70 (25.0% vs 16.4%; P < .001). Incidence of treatment-emergent adverse events (502 of 565 [88.8%] vs 499 of 566 [88.2%]) and serious treatment-emergent adverse events (49 [8.7%] vs 46 [8.1%]) was similar for both groups. Treatment discontinuations because of adverse events was more common in the ponesimod group (49 of 565 [8.7%] vs 34 of 566 [6.0%]). Conclusions and Relevance In this study, ponesimod was superior to teriflunomide on annualized relapse rate reduction, fatigue, magnetic resonance imaging activity, brain volume loss, and no evidence of disease activity status, but not confirmed disability accumulation. The safety profile was in line with the previous safety observations with ponesimod and the known profile of other S1P receptor modulators. Trial Registration ClinicalTrials.gov Identifier: NCT02425644.",2021,"In this study, ponesimod was superior to teriflunomide on annualized relapse rate reduction, fatigue, magnetic resonance imaging activity, brain volume loss, and no evidence of disease activity status, but not confirmed disability accumulation.","['Patients', 'enrolled patients from April 27, 2015, to May 16, 2019, who were aged 18 to 55 years and had been diagnosed with multiple sclerosis per 2010 McDonald criteria, with a relapsing course from the onset, Expanded Disability Status Scale (EDSS) scores of 0 to 5.5, and recent clinical or magnetic resonance imaging disease activity', '1133 patients (567 receiving ponesimod and 566 receiving teriflunomide; median [range], 37.0 [18-55] years; 735 women [64.9', 'patients with RMS']","['Teriflunomide', 'Oral Ponesimod Versus Teriflunomide', 'ponesimod or 14 mg of teriflunomide once daily and the placebo']","['number of combined unique active lesions per year on magnetic resonance imaging, and time to 12-week and 24-week confirmed disability accumulation', 'serious treatment-emergent adverse events', 'Safety and tolerability', 'Incidence of treatment-emergent adverse events', 'annualized relapse rate reduction, fatigue, magnetic resonance imaging activity, brain volume loss, and no evidence of disease activity status', 'relative risk reduction', 'odds ratio for NEDA-3 achievement', 'adverse events', 'percentage change in brain volume and no evidence of disease activity (NEDA-3 and NEDA-4) status', 'disability accumulation risk estimates', 'Brain volume loss', 'changes in symptom domain of Fatigue Symptom and Impact Questionnaire-Relapsing Multiple Sclerosis (FSIQ-RMS', 'annualized relapse rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205336', 'cui_str': 'Relapsing course'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C2934701', 'cui_str': 'ponesimod'}, {'cui': 'C1718383', 'cui_str': 'teriflunomide'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}]","[{'cui': 'C1718383', 'cui_str': 'teriflunomide'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C2934701', 'cui_str': 'ponesimod'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439508', 'cui_str': '/year'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0332125', 'cui_str': 'No evidence of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}]",,0.411691,"In this study, ponesimod was superior to teriflunomide on annualized relapse rate reduction, fatigue, magnetic resonance imaging activity, brain volume loss, and no evidence of disease activity status, but not confirmed disability accumulation.","[{'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Kappos', 'Affiliation': 'Neurology and Research Center for Clinical Neuroimmunology and Neuroscience Basel, Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering University Hospital and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Fox', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Burcklen', 'Affiliation': 'Actelion Pharmaceuticals, Part of Janssen Pharmaceutical Companies, Allschwil, Switzerland.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Freedman', 'Affiliation': 'Department of Medicine, University of Ottawa, The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Eva K', 'Initials': 'EK', 'LastName': 'Havrdová', 'Affiliation': 'Department of Neurology, First Medical Faculty, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hennessy', 'Affiliation': 'Actelion Pharmaceuticals, Part of Janssen Pharmaceutical Companies, Allschwil, Switzerland.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Hohlfeld', 'Affiliation': 'Institute of Clinical Neuroimmunology, Ludwig Maximilians University Munich, Munich, Germany.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Lublin', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Montalban', 'Affiliation': ""Department of Neurology-Neuroimmunology, Multiple Sclerosis Center of Catalonia, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Pozzilli', 'Affiliation': ""Sant'Andrea Multiple Sclerosis Centre, Sapienza University of Rome, Rome, Italy.""}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Scherz', 'Affiliation': 'Actelion Pharmaceuticals, Part of Janssen Pharmaceutical Companies, Allschwil, Switzerland.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': ""D'Ambrosio"", 'Affiliation': 'Actelion Pharmaceuticals, Part of Janssen Pharmaceutical Companies, Allschwil, Switzerland.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Linscheid', 'Affiliation': 'Actelion Pharmaceuticals, Part of Janssen Pharmaceutical Companies, Allschwil, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Vaclavkova', 'Affiliation': 'Actelion Pharmaceuticals, Part of Janssen Pharmaceutical Companies, Allschwil, Switzerland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Pirozek-Lawniczek', 'Affiliation': 'Actelion Pharmaceuticals, Part of Janssen Pharmaceutical Companies, Allschwil, Switzerland.'}, {'ForeName': 'Hilke', 'Initials': 'H', 'LastName': 'Kracker', 'Affiliation': 'Actelion Pharmaceuticals, Part of Janssen Pharmaceutical Companies, Allschwil, Switzerland.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Sprenger', 'Affiliation': 'Neurology and Research Center for Clinical Neuroimmunology and Neuroscience Basel, Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering University Hospital and University of Basel, Basel, Switzerland.'}]",JAMA neurology,['10.1001/jamaneurol.2021.0405'] 2771,33789169,The effect of acute alcohol consumption on meal memory and subsequent food intake: Two laboratory experiments.,"Altering the quality of episodic meal memories has been shown to affect subsequent food intake. Acute alcohol consumption disrupts memory formation and produces short-term overeating. In two studies, we investigated whether alcohol consumption can affect meal-related memories and later food intake. Study 1 (N = 60, 50% male) investigated how consumption of an alcoholic drink (0.5 g/kg) prior to consumption of a lunch meal affected meal memory of that lunch, and later food intake, compared with a placebo-alcohol. Findings revealed that alcohol consumption did not impair meal memory, and did not affect subsequent food intake. Study 2 (N = 72, 50% male) investigated whether, due to alcohol's retrograde facilitation effect (the enhancement of recall due to reduced interference at the point of exposure) consuming alcohol after consumption of a lunch meal could enhance meal memory, compared with when consumed before a lunch meal (both a dosage of 0.6 g/kg), and compared with consumption of a soft drink. Contrary to prediction, alcohol consumed after a lunch meal did not significantly increase meal memory. But, certain types of meal memory were impaired when alcohol was consumed before the meal, compared with consumption of a soft drink. Subsequent food intake did not differ between conditions. Taken together, findings suggest that alcohol intoxication can impair some forms of meal memory recall, likely due to disruption of memory formation during the encoding phase. However, there was no evidence that this impairment contributes towards alcohol-induced overeating.",2021,Subsequent food intake did not differ between conditions.,"['Study 2 (N = 72, 50% male']","['acute alcohol consumption', 'alcoholic drink (0.5 g/kg) prior to consumption of a lunch meal affected meal memory of that lunch, and later food intake, compared with a placebo-alcohol']","['meal memory and subsequent food intake', 'meal memory']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]","[{'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0013470', 'cui_str': 'Eating'}]",,0.0220721,Subsequent food intake did not differ between conditions.,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gough', 'Affiliation': 'Department of Psychology, University of Liverpool, Eleanor Rathbone Building, Bedford Street South, Liverpool, L69 7ZA, UK. Electronic address: tomgough@liverpool.ac.uk.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Christiansen', 'Affiliation': 'Department of Psychology, University of Liverpool, Eleanor Rathbone Building, Bedford Street South, Liverpool, L69 7ZA, UK.'}, {'ForeName': 'Abigail K', 'Initials': 'AK', 'LastName': 'Rose', 'Affiliation': 'Department of Psychology, University of Liverpool, Eleanor Rathbone Building, Bedford Street South, Liverpool, L69 7ZA, UK; Liverpool Centre for Alcohol Research, Liverpool Health Partners, IC3, Liverpool Science Park, Liverpool, UK.'}, {'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Hardman', 'Affiliation': 'Department of Psychology, University of Liverpool, Eleanor Rathbone Building, Bedford Street South, Liverpool, L69 7ZA, UK.'}]",Appetite,['10.1016/j.appet.2021.105225'] 2772,33794971,Family Talk versus usual services in improving child and family psychosocial functioning in families with parental mental illness (PRIMERA-Promoting Research and Innovation in Mental hEalth seRvices for fAmilies and children): study protocol for a randomised controlled trial.,"BACKGROUND Parental mental illness is common and can lead to dependent children incurring a high risk of developing mental disorders, physical illness, and impaired educational and occupational outcomes. Family Talk is one of the better known interventions designed to prevent the intergenerational transmission of mental illness. However, its evidence base is small, with few robust independent randomised controlled trials, and no associated process or cost evaluations. The PRIMERA (Promoting Research and Innovation in Mental hEalth seRvices for fAmilies and children) research programme involves a mixed method evaluation of Family Talk which is being delivered in mental health settings in Ireland to improve child and family psychosocial functioning in families with parental mental illness. METHODS The study comprises a multi-centre, randomised controlled trial (RCT), with nested economic and process evaluations, to assess the clinical and cost-effectiveness and implementation mechanisms of Family Talk compared to usual services. The study is being conducted in 15 adult and child mental health settings in Ireland. Families with a parent with mental illness, and children aged 5-18 years (n = 144 families) will be randomised to either the 7-session Family Talk programme (n = 96) or to standard care (n = 48) using a 2:1 allocation ratio. The primary outcomes are child psychosocial functioning and family functioning. Secondary outcomes are as follows: understanding and experience of parental mental illness, parental mental health, child and parental resilience, partner wellbeing and service utilisation. Blind assessments will take place at pre-intervention and at 6- and 12-month follow-up. DISCUSSION Given the prevalence and burden of intergenerational mental illness, it is imperative that prevention through evidence-based interventions becomes a public health priority. The current study will provide an important contribution to the international evidence base for Family Talk whilst also helping to identify key implementation lessons in the scaling up of Family Talk, and other similar interventions, within routine mental health settings. TRIAL REGISTRATION ISRCTN Registry, ISRCTN13365858 . Registered 5th February 2019.",2021,"The PRIMERA (Promoting Research and Innovation in Mental hEalth seRvices for fAmilies and children) research programme involves a mixed method evaluation of Family Talk which is being delivered in mental health settings in Ireland to improve child and family psychosocial functioning in families with parental mental illness. ","['Families with a parent with mental illness, and children aged 5-18\u2009years (n\u2009=\u2009144 families', '15 adult and child mental health settings in Ireland', 'families with parental mental illness']","['Family Talk versus usual services', '7-session Family Talk programme (n\u2009=\u200996) or to standard care']","['follows: understanding and experience of parental mental illness, parental mental health, child and parental resilience, partner wellbeing and service utilisation', 'child psychosocial functioning and family functioning']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0015576', 'cui_str': 'Family'}]",15.0,0.167183,"The PRIMERA (Promoting Research and Innovation in Mental hEalth seRvices for fAmilies and children) research programme involves a mixed method evaluation of Family Talk which is being delivered in mental health settings in Ireland to improve child and family psychosocial functioning in families with parental mental illness. ","[{'ForeName': 'Mairead', 'Initials': 'M', 'LastName': 'Furlong', 'Affiliation': 'Centre for Mental Health and Community Research, Department of Psychology and Social Sciences Institute, Maynooth University, Maynooth, Co. Kildare, Ireland. Mairead.Furlong@mu.ie.'}, {'ForeName': 'Sinead', 'Initials': 'S', 'LastName': 'McGilloway', 'Affiliation': 'Centre for Mental Health and Community Research, Department of Psychology and Social Sciences Institute, Maynooth University, Maynooth, Co. Kildare, Ireland.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Mulligan', 'Affiliation': 'Centre for Mental Health and Community Research, Department of Psychology and Social Sciences Institute, Maynooth University, Maynooth, Co. Kildare, Ireland.'}, {'ForeName': 'Colm', 'Initials': 'C', 'LastName': 'McGuinness', 'Affiliation': 'Department of Business, Technological University Dublin, Blanchardstown Campus, Dublin, Ireland.'}, {'ForeName': 'Nuala', 'Initials': 'N', 'LastName': 'Whelan', 'Affiliation': 'Department of Sociology, Maynooth University, Maynooth, Co. Kildare, Ireland.'}]",Trials,['10.1186/s13063-021-05199-4'] 2773,33794969,"Evaluating the efficacy of a multistrain probiotic supplementation for prevention of neonatal sepsis in 0-2-month-old low birth weight infants in India-the ""ProSPoNS"" Study protocol for a phase III, multicentric, randomized, double-blind, placebo-controlled trial.","BACKGROUND Progress has been made in the reduction of under-five mortality in India; however, neonatal mortality is reducing at a slower rate. Efforts are required to bring down neonatal mortality in order to attain the Sustainable Development Goal-3. Prevention of sepsis among the high-risk, vulnerable low birth weight neonates by a newer intervention with probiotic supplementation is promising. METHODS A phase III, multicenter, randomized, double-blind, placebo-controlled study is being conducted at six sites in India. A total of 6144 healthy low birth weight (LBW) infants fulfilling the eligibility criteria would be enrolled within the first week of life, after obtaining written informed consent from the parents of the infant. Randomization in 1:1 ratio, stratified by site, sex, and birth weight, would be done through an interactive web response system (IWRS) using a standard web browser and email service. Vivomixx®, a probiotic containing a mix of 8 strains of bacteria, in a suspension form standardized to deliver 10 billion CFU/ml, or an organoleptically similar placebo would be fed to enrolled infants in a 1-ml/day dose for 30 days. The follow-up of enrolled infants for 60 days would take place as per a pre-specified schedule for recording morbidities and outcome assessments at the six participating sites. Screening for morbidities would be conducted by trained field workers in the community, and sick infants would be referred to designated clinics/hospitals. A physician would examine the referred infants presenting with complaints and clinical signs, and blood samples would be collected from sick infants for diagnosis of neonatal sepsis by performing sepsis screen and blood culture. Appropriate treatment would be provided as per hospital protocol. The study would be implemented as per the MRC guideline for the management of Global Health Trials in accordance with ICH-GCP and Indian Regulatory guidelines. A contract research organization would be engaged for comprehensive monitoring and quality assurance. The final analysis would be conducted in a blinded manner as per the statistical analysis plan (SAP) to estimate the primary outcomes of sepsis, possible serious bacterial infection (PSBI), and secondary outcomes. The codes will be broken after DMC permission. The protocol has been reviewed by the Research Ethics Committee of the Liverpool School of Tropical Medicine (REC-LSTM), from Research Ethics Committees of the six subject recruitment participating sites. DISCUSSION This adequately powered and well-designed trial would conclusively answer the question whether probiotics can prevent neonatal sepsis in the high-risk group of low birth weight infants as indicated by a pilot study in 1340 LBW infants, evidence from systematic reviews of hospital-based studies, and a primary study on healthy newborns in Orissa. Results of the study would be generalizable to India and other low-middle-income countries. TRIAL REGISTRATION Clinical Trial Registry of India (CTRI) CTRI/2019/05/019197 . Registered on 16 May 2019.",2021,"A total of 6144 healthy low birth weight (LBW) infants fulfilling the eligibility criteria would be enrolled within the first week of life, after obtaining written informed consent from the parents of the infant.","['6144 healthy low birth weight (LBW) infants fulfilling the eligibility criteria would be enrolled within the first week of life, after obtaining written informed consent from the parents of the infant', 'six sites in India', '0-2-month-old low birth weight infants in India', 'healthy newborns in Orissa', '1340 LBW infants']","['probiotic supplementation', 'placebo', 'multistrain probiotic supplementation']",['neonatal sepsis'],"[{'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021288', 'cui_str': 'Low birth weight infant'}, {'cui': 'C0578757', 'cui_str': 'Good neonatal condition at birth'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456103', 'cui_str': 'Sepsis of the newborn'}]",6144.0,0.65759,"A total of 6144 healthy low birth weight (LBW) infants fulfilling the eligibility criteria would be enrolled within the first week of life, after obtaining written informed consent from the parents of the infant.","[{'ForeName': 'Anju Pradhan', 'Initials': 'AP', 'LastName': 'Sinha', 'Affiliation': 'Division of Reproductive Biology, Maternal & Child Health (RBM&CH), Indian Council of Medical Research (ICMR) Headquarters, V Ramalingaswami Bhawan, Ansari Nagar, New Delhi, Delhi, 110029, India. apradhandr@gmail.com.'}, {'ForeName': 'Subodh S', 'Initials': 'SS', 'LastName': 'Gupta', 'Affiliation': 'Department of Community Medicine, Dr. Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences (MGIMS), Sewagram, Wardha, Maharashtra, 442102, India.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Poluru', 'Affiliation': 'The International Clinical Epidemiology Network (INCLEN) Trust International, F-1/5, 2nd Floor, Okhla Industrial Area Phase - 1, New Delhi, Delhi, 110019, India.'}, {'ForeName': 'Abhishek V', 'Initials': 'AV', 'LastName': 'Raut', 'Affiliation': 'Department of Community Medicine, Dr. Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences (MGIMS), Sewagram, Wardha, Maharashtra, 442102, India.'}, {'ForeName': 'Narendra Kumar', 'Initials': 'NK', 'LastName': 'Arora', 'Affiliation': 'The International Clinical Epidemiology Network (INCLEN) Trust International, F-1/5, 2nd Floor, Okhla Industrial Area Phase - 1, New Delhi, Delhi, 110019, India.'}, {'ForeName': 'Ravindra Mohan', 'Initials': 'RM', 'LastName': 'Pandey', 'Affiliation': 'Department of Biostatistics, All India Institute of Medical Sciences (AIIMS), New Delhi, Delhi, 110029, India.'}, {'ForeName': 'Aditya Ranjan', 'Initials': 'AR', 'LastName': 'Sahu', 'Affiliation': 'Next Gen Pharma India Pvt. Ltd., 331, Sector 15A, Noida, Uttar Pradesh, 201301, India.'}, {'ForeName': 'Adhisivam', 'Initials': 'A', 'LastName': 'Bethou', 'Affiliation': 'Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Dhanvantri Nagar, Gorimedu, Puducherry, 605006, India.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Sazawal', 'Affiliation': 'Centre for Public Health Kinetics (CPHK), 214 A, Vinoba Puri, Lajpat Nagar-II, New Delhi, Delhi, 110024, India.'}, {'ForeName': 'Sailajanandan', 'Initials': 'S', 'LastName': 'Parida', 'Affiliation': 'Neonatal Health & Human Nutrition, Asian Institute of Public Health (AIPH), 8A, Unit-6, Ganga Nagar (Near Raj Bhawan), Bhubaneswar, Odisha, 751001, India.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Bavdekar', 'Affiliation': 'Department of Pediatrics, KEM Hospital Research Centre, 489 Rasta Peth, Sardar Moodliar Road, Pune, Maharashtra, 411011, India.'}, {'ForeName': 'Arvind', 'Initials': 'A', 'LastName': 'Saili', 'Affiliation': ""Department of Neonatology, Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital (KSCH), Near Gole Market, Central Dist., New Delhi, Delhi, 110001, India.""}, {'ForeName': 'Rajni', 'Initials': 'R', 'LastName': 'Gaind', 'Affiliation': 'Department of Microbiology, Vardhaman Mahavir Medical College and Safdarjung Hospital (VMMC & SJH), Ansari Nagar (W), New Delhi, Delhi, 110029, India.'}, {'ForeName': 'Arti', 'Initials': 'A', 'LastName': 'Kapil', 'Affiliation': 'Department of Microbiology, All India Institute of Medical Sciences (AIIMS), New Delhi, Delhi, 110029, India.'}, {'ForeName': 'Bishan S', 'Initials': 'BS', 'LastName': 'Garg', 'Affiliation': 'Department of Community Medicine, Dr. Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences (MGIMS), Sewagram, Wardha, Maharashtra, 442102, India.'}, {'ForeName': 'Chetna', 'Initials': 'C', 'LastName': 'Maliye', 'Affiliation': 'Department of Community Medicine, Dr. Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences (MGIMS), Sewagram, Wardha, Maharashtra, 442102, India.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Jain', 'Affiliation': 'Department of Community Medicine, Dr. Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences (MGIMS), Sewagram, Wardha, Maharashtra, 442102, India.'}, {'ForeName': 'Kamlesh S', 'Initials': 'KS', 'LastName': 'Mahajan', 'Affiliation': 'Department of Community Medicine, Dr. Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences (MGIMS), Sewagram, Wardha, Maharashtra, 442102, India.'}, {'ForeName': 'Pratibha', 'Initials': 'P', 'LastName': 'Dhingra', 'Affiliation': 'Centre for Public Health Kinetics (CPHK), 214 A, Vinoba Puri, Lajpat Nagar-II, New Delhi, Delhi, 110024, India.'}, {'ForeName': 'Keshab C', 'Initials': 'KC', 'LastName': 'Pradhan', 'Affiliation': 'Neonatal Health & Human Nutrition, Asian Institute of Public Health (AIPH), 8A, Unit-6, Ganga Nagar (Near Raj Bhawan), Bhubaneswar, Odisha, 751001, India.'}, {'ForeName': 'Anand S', 'Initials': 'AS', 'LastName': 'Kawade', 'Affiliation': 'Department of Pediatrics, KEM Hospital Research Centre, 489 Rasta Peth, Sardar Moodliar Road, Pune, Maharashtra, 411011, India.'}, {'ForeName': 'Sushma', 'Initials': 'S', 'LastName': 'Nangia', 'Affiliation': ""Department of Neonatology, Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital (KSCH), Near Gole Market, Central Dist., New Delhi, Delhi, 110001, India.""}, {'ForeName': 'Ajit', 'Initials': 'A', 'LastName': 'Mukherjee', 'Affiliation': 'Division of Reproductive Biology, Maternal & Child Health (RBM&CH), Indian Council of Medical Research (ICMR) Headquarters, V Ramalingaswami Bhawan, Ansari Nagar, New Delhi, Delhi, 110029, India.'}, {'ForeName': 'Reeta', 'Initials': 'R', 'LastName': 'Rasaily', 'Affiliation': 'Division of Reproductive Biology, Maternal & Child Health (RBM&CH), Indian Council of Medical Research (ICMR) Headquarters, V Ramalingaswami Bhawan, Ansari Nagar, New Delhi, Delhi, 110029, India.'}, {'ForeName': 'Radhey Shyam', 'Initials': 'RS', 'LastName': 'Sharma', 'Affiliation': 'Division of Reproductive Biology, Maternal & Child Health (RBM&CH), Indian Council of Medical Research (ICMR) Headquarters, V Ramalingaswami Bhawan, Ansari Nagar, New Delhi, Delhi, 110029, India.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-021-05193-w'] 2774,33794182,Epigenetic age acceleration changes 2 years after antiretroviral therapy initiation in adults with HIV: a substudy of the NEAT001/ANRS143 randomised trial.,"BACKGROUND DNA methylation-based estimators of biological age are reliable biomarkers of the ageing process. We aimed to investigate a range of epigenetic ageing biomarkers in a substudy of the NEAT001/ANRS143 clinical trial, which compared ritonavir-boosted darunavir with either raltegravir or tenofovir disoproxil fumarate and emtricitabine in antiretroviral therapy (ART)-naive adults. METHODS We analysed frozen whole blood samples from 168 ART-naive participants with HIV from the NEAT001/ANRS143 trial, before ART initiation and after 2 years of ART (84 participants on ritonavir-boosted darunavir with raltegravir and 84 participants on ritonavir-boosted darunavir with tenofovir disoproxil fumarate and emtricitabine). We also included 44 participants without HIV with a similar age and sex distribution. We analysed DNA methylation. Epigenetic age estimators (Horvath's clock, Hannum's clock, GrimAge, and PhenoAge) and estimated leucocyte compositions were generated using Horvath's New Online Methylation Age Calculator and Houseman's method. We calculated epigenetic age acceleration measures for each estimator of epigenetic age. The NEAT001/ANRS143 trial is registered with ClinicalTrials.gov, NCT01066962. FINDINGS Compared with the HIV-uninfected group, ART-naive participants with HIV showed higher epigenetic age acceleration (EAA) according to all EAA estimators (mean 2·5 years, 95% CI 1·89-3·22 for Horvath-EAA; 1·4 years, 0·74-1·99 for Hannum-EAA; 2·8 years, 1·97-3·68 for GrimAge-EAA; and 7·3 years, 6·40-8·13 for PhenoAge-EAA), with all differences being statistically significant except for Hannum-EAA (Horvath-EAA p=0·0008; Hannum-EAA p=0·059; GrimAge-EAA p=0·0021; and PhenoAge-EAA p<0·0001). Epigenetic ageing was more pronounced in participants who had CD4 counts less than 200 cells per μL (significant for PhenoAge and Hannum's clock, p=0·0015 and p=0·034, respectively) or viral loads over 100 000 copies per mL at baseline (significant for PhenoAge, p=0·017). After 2 years of ART, epigenetic age acceleration was reduced, although PhenoAge and GrimAge remained significantly higher in participants with HIV compared with participants without HIV (mean difference 3·69 years, 95% CI 1·77-5·61; p=0·0002 and 2·2 years, 0·47-3·99; p=0·013, respectively). There were no significant differences in the ART effect on epigenetic ageing between treatment regimens. At baseline, participants with HIV showed dysregulation of DNA methylation-based estimated leucocyte subsets towards more differentiated T-cell phenotypes and proinflammatory leucocytes, which was also partly restored with ART. INTERPRETATION ART initiation partly reversed epigenetic ageing associated with untreated HIV infection. Further studies are needed to understand the long-term dynamics and clinical relevance of epigenetic ageing biomarkers in people with HIV. FUNDING NEAT-ID Foundation.",2021,"After 2 years of ART, epigenetic age acceleration was reduced, although PhenoAge and GrimAge remained significantly higher in participants with HIV compared with participants without HIV (mean difference 3·69 years, 95% CI 1·77-5·61; p=0·0002 and 2·2 years, 0·47-3·99; p=0·013, respectively).","['and 84 participants on', 'adults with HIV', 'antiretroviral therapy (ART)-naive adults', 'people with HIV', '168 ART-naive participants with HIV from the NEAT001/ANRS143 trial, before ART initiation and after 2 years of ART (84 participants on', '44 participants without HIV with a similar age and sex distribution']","['ritonavir-boosted darunavir with either raltegravir or tenofovir disoproxil fumarate and emtricitabine', 'ritonavir-boosted darunavir with raltegravir', 'ritonavir-boosted darunavir with tenofovir disoproxil fumarate and emtricitabine']","['Epigenetic ageing', 'viral loads', 'higher epigenetic age acceleration (EAA', 'PhenoAge and GrimAge', 'epigenetic age acceleration', 'ART effect on epigenetic ageing']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0036878', 'cui_str': 'Sex Distribution'}]","[{'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C1435444', 'cui_str': 'darunavir'}, {'cui': 'C1871526', 'cui_str': 'raltegravir'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}]","[{'cui': 'C1655731', 'cui_str': 'Epigenetic'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",44.0,0.435431,"After 2 years of ART, epigenetic age acceleration was reduced, although PhenoAge and GrimAge remained significantly higher in participants with HIV compared with participants without HIV (mean difference 3·69 years, 95% CI 1·77-5·61; p=0·0002 and 2·2 years, 0·47-3·99; p=0·013, respectively).","[{'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Esteban-Cantos', 'Affiliation': 'HIV/AIDS and Infectious Diseases Research Group, Hospital Universitario La Paz-IdiPAZ, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Rodríguez-Centeno', 'Affiliation': 'HIV/AIDS and Infectious Diseases Research Group, Hospital Universitario La Paz-IdiPAZ, Madrid, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Barruz', 'Affiliation': 'Genomics Laboratory, Hospital Universitario La Paz-IdiPAZ, Madrid, Spain.'}, {'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Alejos', 'Affiliation': 'Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Saiz-Medrano', 'Affiliation': 'HIV/AIDS and Infectious Diseases Research Group, Hospital Universitario La Paz-IdiPAZ, Madrid, Spain.'}, {'ForeName': 'Julián', 'Initials': 'J', 'LastName': 'Nevado', 'Affiliation': 'Genomics Laboratory, Hospital Universitario La Paz-IdiPAZ, Madrid, Spain.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'HIV/AIDS and Infectious Diseases Research Group, Hospital Universitario La Paz-IdiPAZ, Madrid, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Gayá', 'Affiliation': 'Biostatistic Unit, Hospital Universitario La Paz-IdiPAZ, Madrid, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'De Miguel', 'Affiliation': 'HIV/AIDS and Infectious Diseases Research Group, Hospital Universitario La Paz-IdiPAZ, Madrid, Spain; Infectious Diseases Unit, Department of Internal Medicine, Hospital Universitario La Paz-IdiPAZ, Madrid, Spain.'}, {'ForeName': 'Jose I', 'Initials': 'JI', 'LastName': 'Bernardino', 'Affiliation': 'HIV/AIDS and Infectious Diseases Research Group, Hospital Universitario La Paz-IdiPAZ, Madrid, Spain; Infectious Diseases Unit, Department of Internal Medicine, Hospital Universitario La Paz-IdiPAZ, Madrid, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Montejano', 'Affiliation': 'HIV/AIDS and Infectious Diseases Research Group, Hospital Universitario La Paz-IdiPAZ, Madrid, Spain; Infectious Diseases Unit, Department of Internal Medicine, Hospital Universitario La Paz-IdiPAZ, Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Mena-Garay', 'Affiliation': 'HIV/AIDS and Infectious Diseases Research Group, Hospital Universitario La Paz-IdiPAZ, Madrid, Spain.'}, {'ForeName': 'Julen', 'Initials': 'J', 'LastName': 'Cadiñanos', 'Affiliation': 'HIV/AIDS and Infectious Diseases Research Group, Hospital Universitario La Paz-IdiPAZ, Madrid, Spain; Infectious Diseases Unit, Department of Internal Medicine, Hospital Universitario La Paz-IdiPAZ, Madrid, Spain.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Florence', 'Affiliation': 'Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Mulcahy', 'Affiliation': ""St James's Hospital, Dublin, Ireland.""}, {'ForeName': 'Denes', 'Initials': 'D', 'LastName': 'Banhegyi', 'Affiliation': 'Szent Laszlo Hospital, Budapest, Hungary.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Antinori', 'Affiliation': 'National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Pozniak', 'Affiliation': 'Chelsea and Westminster Hospital, London, UK.'}, {'ForeName': 'Cédrick', 'Initials': 'C', 'LastName': 'Wallet', 'Affiliation': 'University of Bordeaux, INSERM, Bordeaux Population Health Research Center, CHU de Bordeaux, Bordeaux, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Raffi', 'Affiliation': 'University Hospital and INSERM CIC 1413 Nantes University, Nantes, France.'}, {'ForeName': 'Berta', 'Initials': 'B', 'LastName': 'Rodés', 'Affiliation': 'HIV/AIDS and Infectious Diseases Research Group, Hospital Universitario La Paz-IdiPAZ, Madrid, Spain.'}, {'ForeName': 'Jose R', 'Initials': 'JR', 'LastName': 'Arribas', 'Affiliation': 'HIV/AIDS and Infectious Diseases Research Group, Hospital Universitario La Paz-IdiPAZ, Madrid, Spain; Infectious Diseases Unit, Department of Internal Medicine, Hospital Universitario La Paz-IdiPAZ, Madrid, Spain. Electronic address: joser.arribas@salud.madrid.org.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(21)00006-0'] 2775,33794181,"Long-acting cabotegravir plus rilpivirine for treatment in adults with HIV-1 infection: 96-week results of the randomised, open-label, phase 3 FLAIR study.","BACKGROUND There is a need for more convenient, less frequent treatment to help address challenges associated with daily oral HIV treatment in people living with HIV, including stigma, pill burden, drug-food interactions, and adherence. The phase 3 ATLAS and FLAIR studies showed non-inferiority of long-acting cabotegravir and rilpivirine dosed every 4 weeks compared with standard oral therapy for the maintenance of virological suppression in adults with HIV-1 over 48 weeks. We present the 96-week findings. METHODS FLAIR is a randomised, phase 3, open-label, multicentre study done in 11 countries investigating whether switching to long-acting cabotegravir and rilpivirine is non-inferior to daily dolutegravir, abacavir, and lamivudine in virologically suppressed adults living with HIV-1. Antiretroviral therapy (ART)-naive participants received induction therapy with daily oral dolutegravir (50 mg), abacavir (600 mg), and lamivudine (300 mg) for 20 weeks. After 16 weeks, participants with less than 50 HIV-1 RNA copies per mL were randomly assigned (1:1) to continue the standard of care regimen (standard care group) or switch to receive daily oral cabotegravir 30 mg and rilpivirine 25 mg for at least 4 weeks followed by long-acting cabotegravir 400 mg and rilpivirine 600 mg, administered as two 2 mL intramuscular injections, every 4 weeks for at least 96 weeks (long-acting group). Randomisation was stratified by baseline (preinduction) HIV-1 RNA (<100 000 or ≥100 000 copies per mL) and sex at birth and used GlaxoSmithKline-verified randomisation software (RandAll NG, version 1.3.3) for treatment assignment. The primary endpoint was the proportion of participants with plasma HIV-1 RNA of 50 copies per mL or more assessed as per the US Food and Drug Administration (FDA) Snapshot algorithm at week 48, which has been reported previously. Here, we report the proportion of participants with 50 or more HIV-1 RNA copies per mL using the FDA Snapshot algorithm at week 96 (intention-to-treat population; non-inferiority margin 6%). The trial is registered with ClinicalTrials.gov, NCT02938520. FINDINGS Between Oct 27, 2016, and March 24, 2017, 809 participants were screened. 631 (78%) participants entered the induction phase and 566 (70%) were randomly assigned to either the standard care group (283 [50%] participants) or the long-acting group (283 [50%]). Median age was 34 years (IQR 29 to 43), 62 (11%) were 50 years or older, 127 (22%) were women (sex at birth), and 419 (74%) were white. At week 96, nine (3%) participants in each arm had 50 or more HIV-1 RNA copies per mL, with an adjusted difference of 0·0 (95% CI -2·9 to 2·9), consistent with non-inferiority established at week 48. Across both treatment groups, adverse events leading to withdrawal were infrequent (14 [5%] participants in the long-acting group and four [1%] in the standard care group). Injection site reactions were the most common adverse event, reported by 245 (88%) participants in the long-acting group; their frequency decreased over time. Median injection site reaction duration was 3 days (IQR 2 to 4), and 3082 (99%) of 3100 reactions were grade 1 or 2. No deaths occurred during the maintenance phase. INTERPRETATION The 96-week results reaffirm the 48-week results, showing long-acting cabotegravir and rilpivirine continued to be non-inferior compared with continuing a standard care regimen in adults with HIV-1 for the maintenance of viral suppression. These results support the durability of long-acting cabotegravir and rilpivirine, over an almost 2-year-long period, as a therapeutic option for virally suppressed adults with HIV-1. FUNDING ViiV Healthcare and Janssen Research and Development.",2021,"Injection site reactions were the most common adverse event, reported by 245 (88%) participants in the long-acting group; their frequency decreased over time.","['Median age was 34 years (IQR 29 to 43), 62 (11%) were 50 years or older, 127 (22%) were women (sex at birth), and 419 (74%) were white', 'adults with HIV-1 infection', 'participants with 50 or more HIV-1 RNA copies per mL using the FDA Snapshot algorithm at week 96 (intention-to-treat population; non-inferiority margin 6', 'participants entered the induction phase and 566 (70', 'adults with HIV-1 over 48 weeks', 'Between Oct 27, 2016, and March 24, 2017, 809 participants were screened', 'participants with less than 50 HIV-1', '631 (78', 'virally suppressed adults with HIV-1', 'adults with HIV-1 for the maintenance of viral suppression', '11 countries investigating whether switching to long-acting cabotegravir and rilpivirine is non-inferior to daily dolutegravir, abacavir, and lamivudine in virologically suppressed adults living with HIV-1']","['Antiretroviral therapy', 'induction therapy with daily oral dolutegravir', 'abacavir', 'Long-acting cabotegravir plus rilpivirine', 'lamivudine', 'rilpivirine', 'care regimen (standard care group) or switch to receive daily oral cabotegravir 30 mg and rilpivirine 25 mg for at least 4 weeks followed by long-acting cabotegravir 400 mg and rilpivirine']","['proportion of participants with plasma HIV-1 RNA', 'deaths', 'adverse events leading to withdrawal', 'Median injection site reaction duration']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2363741', 'cui_str': 'HIV-1 infection'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C1566826', 'cui_str': 'Rilpivirine'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0663655', 'cui_str': 'abacavir'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0663655', 'cui_str': 'abacavir'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1566826', 'cui_str': 'Rilpivirine'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3154703', 'cui_str': 'Rilpivirine 25 MG'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C3816746', 'cui_str': '400'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",809.0,0.461344,"Injection site reactions were the most common adverse event, reported by 245 (88%) participants in the long-acting group; their frequency decreased over time.","[{'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Orkin', 'Affiliation': 'Department of Immunobiology, Queen Mary University, London, UK. Electronic address: c.m.orkin@qmul.ac.uk.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Oka', 'Affiliation': 'AIDS Clinical Center, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Philibert', 'Affiliation': 'Department for Internal Medicine and Infectious Diseases, Hôpital Européen, Marseille, France.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Brinson', 'Affiliation': 'Central Texas Clinical Research, Austin, TX, USA.'}, {'ForeName': 'Ayesha', 'Initials': 'A', 'LastName': 'Bassa', 'Affiliation': 'Mzansi Ethical Research Centre, Middelburg, South Africa.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Gusev', 'Affiliation': 'State Medical Center for the Prevention and Control of AIDS and Infectious Diseases, St Petersburg, Russia; St Petersburg State Budgetary Health Care Institution, St Petersburg, Russia.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Degen', 'Affiliation': 'Infectious Diseases Unit, Outpatient Center, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Juan González', 'Initials': 'JG', 'LastName': 'García', 'Affiliation': 'Department for Internal Medicine, Hospital La Paz Institute for Health Research, Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Enrique Bernal', 'Initials': 'EB', 'LastName': 'Morell', 'Affiliation': 'Sección de Enfermedades Infecciosas, Hospital General Universitario Reina Sofía, Murcia, Spain.'}, {'ForeName': 'Darrell H S', 'Initials': 'DHS', 'LastName': 'Tan', 'Affiliation': ""Division of Infectious Diseases, Department of Medicine, St Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': ""D'Amico"", 'Affiliation': 'Research and Development, ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dorey', 'Affiliation': 'Biostatistics, GlaxoSmithKline, Mississauga, ON, Canada.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Griffith', 'Affiliation': 'Research and Development, ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Shanker', 'Initials': 'S', 'LastName': 'Thiagarajah', 'Affiliation': 'SMG Pharma Safety, GlaxoSmithKline, Research Triangle Park, NC, USA.'}, {'ForeName': 'Marty', 'Initials': 'M', 'LastName': 'St Clair', 'Affiliation': 'Translational Medical Research, ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Rodica', 'Initials': 'R', 'LastName': 'Van Solingen-Ristea', 'Affiliation': 'Infectious Diseases & Vaccines, Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Herta', 'Initials': 'H', 'LastName': 'Crauwels', 'Affiliation': 'Infectious Diseases & Vaccines, Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Ford', 'Affiliation': 'Clinical Pharmacology, GlaxoSmithKline, Research Triangle Park, NC, USA.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Research and Development, ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Chounta', 'Affiliation': 'Health Outcomes Team, ViiV Healthcare, Brentford, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Vanveggel', 'Affiliation': 'Global Development, Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Cutrell', 'Affiliation': 'Research Statistics, ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Van Eygen', 'Affiliation': 'Infectious Diseases & Vaccines, Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Vandermeulen', 'Affiliation': 'Infectious Diseases & Vaccines, Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Margolis', 'Affiliation': 'Research and Development, ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Kimberly Y', 'Initials': 'KY', 'LastName': 'Smith', 'Affiliation': 'Research and Development, ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Spreen', 'Affiliation': 'Research and Development, ViiV Healthcare, Research Triangle Park, NC, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30340-4'] 2776,33792764,"Modified Talk Test: a Randomized Cross-over Trial Investigating the Comparative Utility of Two ""Talk Tests"" for Determining Aerobic Training Zones in Overweight and Obese Patients.","BACKGROUND To validate the traditional talk test (TTT) and an alternative talk test (ATT; using a visual analog scale) in overweight/obese (OW-OB) patients and to establish its accuracy in determining the aerobic training zones. METHODS We recruited 19 subjects aged 34.9 ± 6.7 years, diagnosed with overweight/obesity (BMI 31.8 ± 5.7). Every subject underwent incremental cycloergometric tests for maximal oxygen consumption, and TTT in a randomized order. At the end of each stage during the TTT, each subject read out loud a 40 words text and then had to identify the comfort to talk in two modalities: TTT which consisted in answering ""Yes,"" ""I don't know,"" or ""No"" to the question Was talking comfortable?, or ATT through a 1 to 10 numeric perception scale (visual analog scale (VAS)). The magnitude of differences was interpreted in comparison to the smallest worthwhile change and was used to determine agreement. RESULTS There was an agreement between the power output at the VAS 2-3 of ATT and the power output at the ventilatory threshold 1 (VT1) (very likely equivalent; mean difference - 1.3 W, 90% confidence limit (CL) (- 8.2; 5.6), percent chances for higher/similar/lower values of 0.7/99.1/0.2%). Also, there was an agreement between the power output at the VAS 6-7 of ATT and the power output at the ventilatory threshold 2 (VT2) (very likely equivalent; mean difference 11.1 W, 90% CL (2.8; 19.2), percent chances for higher/similar/lower values of 0.0/97.6/2.4%). CONCLUSIONS ATT is a tool to determine exercise intensity and to establish aerobic training zones for exercise prescription in OW-OB patients.",2021,"CONCLUSIONS ATT is a tool to determine exercise intensity and to establish aerobic training zones for exercise prescription in OW-OB patients.","['Overweight and Obese Patients', 'overweight/obese (OW-OB) patients', '19 subjects aged 34.9 ± 6.7\u2009years, diagnosed with overweight/obesity (BMI 31.8 ± 5.7', 'OW-OB patients']","['Two ""Talk Tests', 'traditional talk test (TTT) and an alternative talk test (ATT', ' ""I don\'t know,"" or ""No"" to the question Was talking comfortable?, or ATT']",['numeric perception scale (visual analog scale (VAS'],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517795', 'cui_str': '5.7'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C1880386', 'cui_str': ""Don't know""}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",19.0,0.0471831,"CONCLUSIONS ATT is a tool to determine exercise intensity and to establish aerobic training zones for exercise prescription in OW-OB patients.","[{'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Orizola-Cáceres', 'Affiliation': 'Unidad de Fisiología Integrativa, Laboratorio de Ciencias del Ejercicio, Clínica MEDS, Santiago, Chile.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Cerda-Kohler', 'Affiliation': 'Unidad de Fisiología Integrativa, Laboratorio de Ciencias del Ejercicio, Clínica MEDS, Santiago, Chile.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Burgos-Jara', 'Affiliation': 'Unidad de Fisiología Integrativa, Laboratorio de Ciencias del Ejercicio, Clínica MEDS, Santiago, Chile.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Meneses-Valdes', 'Affiliation': 'Unidad de Fisiología Integrativa, Laboratorio de Ciencias del Ejercicio, Clínica MEDS, Santiago, Chile.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Gutierrez-Pino', 'Affiliation': 'Unidad de Fisiología Integrativa, Laboratorio de Ciencias del Ejercicio, Clínica MEDS, Santiago, Chile.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Sepúlveda', 'Affiliation': 'Unidad de Fisiología Integrativa, Laboratorio de Ciencias del Ejercicio, Clínica MEDS, Santiago, Chile. csepulvedag@ug.uchile.cl.'}]",Sports medicine - open,['10.1186/s40798-021-00315-9'] 2777,33797667,Relationship Between Mental Health and HIV Transmission Knowledge and Prevention Attitudes Among Adolescents Living with HIV: Lessons from Suubi + Adherence Cluster Randomized Study in Southern Uganda.,"We assessed the effect of depression, hopelessness, and self-concept on HIV prevention attitudes and knowledge about infection, transmission and sexual risk behavior among adolescents living with HIV in Uganda. Utilizing longitudinal data from 635 adolescents living with HIV, multiple ordinary least square regression was used to evaluate associations between the three indicators of mental health functioning at baseline and HIV knowledge and prevention attitudes at 12-months follow-up. We found that depression (β = - 0.17; 95% CI - 0.31, - 0.04) and hopelessness (β = - 0.16; 95% CI - 0.28, - 0.04) scores at baseline were associated with a 0.17 and 0.16 average reduction in HIV prevention attitudes and HIV knowledge scores, respectively at 12-months follow-up. However, self-concept was not significantly associated with HIV knowledge or prevention attitudes. Adolescents living with HIV with greater levels of hopelessness are at increased risk of having limited HIV knowledge while those with greater symptoms of depression had less favorable HIV prevention attitudes.",2021,"However, self-concept was not significantly associated with HIV knowledge or prevention attitudes.","['Adolescents living with HIV with greater levels of hopelessness', 'Adolescents Living with HIV', '635 adolescents living with HIV, multiple ordinary least square regression', 'Southern Uganda', 'adolescents living with HIV in Uganda']",[],"['HIV knowledge or prevention attitudes', 'Mental Health and HIV Transmission Knowledge and Prevention Attitudes', 'HIV prevention attitudes and knowledge about infection, transmission and sexual risk behavior', 'HIV prevention attitudes and HIV knowledge scores']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0150041', 'cui_str': 'Feeling hopeless'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]",[],"[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",635.0,0.116633,"However, self-concept was not significantly associated with HIV knowledge or prevention attitudes.","[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Byansi', 'Affiliation': 'International Center for Child Health and Development, Brown School, Washington University in St. Louis, St. Louis, MO, 63130, USA. byansiw@wustl.edu.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Brathwaite', 'Affiliation': 'International Center for Child Health and Development, Brown School, Washington University in St. Louis, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Madison', 'Initials': 'M', 'LastName': 'Calvert', 'Affiliation': 'Sargent College of Health and Rehabilitation Sciences, Boston University, Boston, MA, 02215, USA.'}, {'ForeName': 'Proscovia', 'Initials': 'P', 'LastName': 'Nabunya', 'Affiliation': 'International Center for Child Health and Development, Brown School, Washington University in St. Louis, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Ozge', 'Initials': 'O', 'LastName': 'Sensoy Bahar', 'Affiliation': 'International Center for Child Health and Development, Brown School, Washington University in St. Louis, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Damulira', 'Affiliation': 'International Center for Child Health and Development, Brown School, Washington University in St. Louis, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Namuwonge', 'Affiliation': 'International Center for Child Health and Development, Brown School, Washington University in St. Louis, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'McKay', 'Affiliation': 'Brown School, Washington University in St. Louis, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Claude A', 'Initials': 'CA', 'LastName': 'Mellins', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, New York State Psychiatric Institute, Columbia University Medical Center, 1051 Riverside Drive, Box 15, New York, NY, 10032, USA.'}, {'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'International Center for Child Health and Development, Brown School, Washington University in St. Louis, St. Louis, MO, 63130, USA.'}]",AIDS and behavior,['10.1007/s10461-021-03243-7'] 2778,33795646,Translating the immediate effects of S-Ketamine using hippocampal subfield analysis in healthy subjects-results of a randomized controlled trial.,"Antidepressant doses of ketamine rapidly facilitate synaptic plasticity and modify neuronal function within prefrontal and hippocampal circuits. However, most studies have demonstrated these effects in animal models and translational studies in humans are scarce. A recent animal study showed that ketamine restored dendritic spines in the hippocampal CA1 region within 1 h of administration. To translate these results to humans, this randomized, double-blind, placebo-controlled, crossover magnetic resonance imaging (MRI) study assessed ketamine's rapid neuroplastic effects on hippocampal subfield measurements in healthy volunteers. S-Ketamine vs. placebo data were analyzed, and data were also grouped by brain-derived neurotrophic factor (BDNF) genotype. Linear mixed models showed that overall hippocampal subfield volumes were significantly larger (p = 0.009) post ketamine than post placebo (LS means difference=0.008, standard error=0.003). Post-hoc tests did not attribute effects to specific subfields (all p > 0.05). Trend-wise volumetric increases were observed within the left hippocampal CA1 region (p = 0.076), and trend-wise volumetric reductions were obtained in the right hippocampal-amygdaloid transition region (HATA) (p = 0.067). Neither genotype nor a genotype-drug interaction significantly affected the results (all p > 0.7). The study provides evidence that ketamine has short-term effects on hippocampal subfield volumes in humans. The results translate previous findings from animal models of depression showing that ketamine has pro-neuroplastic effects on hippocampal structures and underscore the importance of the hippocampus as a key region in ketamine's mechanism of action.",2021,"Trend-wise volumetric increases were observed within the left hippocampal CA1 region (p = 0.076), and trend-wise volumetric reductions were obtained in the right hippocampal-amygdaloid transition region (HATA) (p = 0.067).","['healthy volunteers', 'healthy subjects', 'humans']","['ketamine', 'placebo', 'S-Ketamine vs. placebo', 'S-Ketamine']","['overall hippocampal subfield volumes', 'left hippocampal CA1 region']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2825616', 'cui_str': 'esketamine'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0694598', 'cui_str': 'CA1 Field of Hippocampus'}]",,0.258445,"Trend-wise volumetric increases were observed within the left hippocampal CA1 region (p = 0.076), and trend-wise volumetric reductions were obtained in the right hippocampal-amygdaloid transition region (HATA) (p = 0.067).","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Höflich', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kraus', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Ruth M', 'Initials': 'RM', 'LastName': 'Pfeiffer', 'Affiliation': 'Biostatistics Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Seiger', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Rujescu', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Martin-Luther-University Halle-Wittenberg, Halle, Germany.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Experimental Therapeutics and Pathophysiology Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Siegfried', 'Initials': 'S', 'LastName': 'Kasper', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Winkler', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Lanzenberger', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria. rupert.lanzenberger@meduniwien.ac.at.'}]",Translational psychiatry,['10.1038/s41398-021-01318-6'] 2779,33795622,Use of Patient Abdominal Compression Device Reduces Staff Musculoskeletal Pain Associated With Supporting Colonoscopy: Results From a Randomized Controlled Trial.,"Work-related musculoskeletal disorders occur frequently among the endoscopy staff, and patient-handling duties involved with colonoscopy-applying manual pressure and repositioning patients-are particularly physically demanding. This study explored whether the use of a lower abdominal compression device (ColoWrap), previously shown to reduce the need for manual pressure and patient repositioning, would diminish the frequency of staff-reported musculoskeletal pain. A randomized, blinded, sham-controlled clinical trial was performed at the University of North Carolina Hospitals. Three hundred fifty patients had either ColoWrap or a sham device applied before colonoscopy. The primary outcome was the frequency of staff-reported musculoskeletal pain after assisting with colonoscopy. In the intention-to-treat analysis, which included procedures in which ColoWrap was removed, there was no statistical difference in the frequency of staff-reported pain in the control versus ColoWrap arm (4.6% vs. 3.4% of procedures, p = .59). However, when ColoWrap was used as directed (e.g., remained in place for the duration of the procedure), the frequency of staff-reported musculoskeletal pain was significantly reduced (4.6% vs. 0.7% of procedures, p = 0.04). Use of ColoWrap as directed was also found to be independently associated with reduced odds of staff-reported pain relative to the sham arm (OR = 0.12; 95% CI [0.02, 0.95]). When used as directed, ColoWrap reduced the frequency of musculoskeletal pain experienced related to assisting with colonoscopy and may reduce the risk of musculoskeletal disorders and injuries among the endoscopy staff.",2021,"Use of ColoWrap as directed was also found to be independently associated with reduced odds of staff-reported pain relative to the sham arm (OR = 0.12; 95% CI [0.02, 0.95]).","['Three hundred fifty patients had either ColoWrap or a sham device applied before colonoscopy', 'University of North Carolina Hospitals']","['Patient Abdominal Compression Device', 'Colonoscopy', 'lower abdominal compression device (ColoWrap']","['frequency of staff-reported pain', 'frequency of staff-reported musculoskeletal pain', 'Staff Musculoskeletal Pain']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}]",350.0,0.352145,"Use of ColoWrap as directed was also found to be independently associated with reduced odds of staff-reported pain relative to the sham arm (OR = 0.12; 95% CI [0.02, 0.95]).","[{'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Crockett', 'Affiliation': 'Seth Crockett, MD, MPH, is Associate Professor of Medicine, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill.'}, {'ForeName': 'Evan S', 'Initials': 'ES', 'LastName': 'Dellon', 'Affiliation': 'Seth Crockett, MD, MPH, is Associate Professor of Medicine, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Biggers', 'Affiliation': 'Seth Crockett, MD, MPH, is Associate Professor of Medicine, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill.'}, {'ForeName': 'Donna A', 'Initials': 'DA', 'LastName': 'Ernst', 'Affiliation': 'Seth Crockett, MD, MPH, is Associate Professor of Medicine, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill.'}]",Gastroenterology nursing : the official journal of the Society of Gastroenterology Nurses and Associates,['10.1097/SGA.0000000000000550'] 2780,33807296,Erector Spinae Plane Block for Perioperative Analgesia after Percutaneous Nephrolithotomy.,"Erector spinae plane block was recently introduced as an alternative to postoperative analgesia in surgical procedures including thoracoscopies and mastectomies. There are no clinical trials regarding erector spinae plane block in percutaneous nephrolithotomy. The aim of our study was to test the efficacy and safety of erector spinae plane block after percutaneous nephrolithotomy. We analyzed 68 patients, 34 of whom received erector spinae plane block. The average visual analogue scale score 24 h postoperatively was the primary endpoint. The secondary endpoints were nalbuphine consumption and the need for rescue analgesia. Safety measures included the mean arterial pressure, Ramsey scale score, and rate of nausea and vomiting. The visual analogue scale, blood pressure, and Ramsey scale were assessed simultaneously at 1, 2, 4, 6, 12, and 24 h postoperatively. The average visual analogue scale was 2.9 and 3 ( p = 0.65) in groups 1 (experimental) and 2 (control), respectively. The visual analogue scale after 1 h postoperatively was significantly lower in the erector spinae plane block group (2.3 vs. 3.3; p = 0.01). The average nalbuphine consumption was the same in both groups (46 mL vs. 47.2 mL, p = 0.69). The need for rescue analgesia was insignificantly different in both groups (group 1, 29.4; group 2, 26.4%; p = 1). The mean arterial pressure was similar in both groups postoperatively (91.8 vs. 92.5 mmHg; p = 0.63). The rate of nausea and vomiting was insignificantly different between the groups (group 1, 17.6%; group 2, 14.7%; p = 1). The median Ramsey scale in all the measurements was two. Erector spinae plane block is an effective pain treatment after percutaneous nephrolithotomy but only for a very short postoperative period.",2021,"The average visual analogue scale was 2.9 and 3 ( p = 0.65) in groups 1 (experimental) and 2 (control), respectively.","['Perioperative Analgesia after Percutaneous Nephrolithotomy', '68 patients, 34 of whom received erector spinae plane block']","['percutaneous nephrolithotomy', 'erector spinae plane block']","['average visual analogue scale score', 'average visual analogue scale', 'efficacy and safety', 'average nalbuphine consumption', 'mean arterial pressure', 'rescue analgesia', 'rate of nausea and vomiting', 'median Ramsey scale', 'nalbuphine consumption and the need for rescue analgesia', 'mean arterial pressure, Ramsey scale score, and rate of nausea and vomiting', 'visual analogue scale, blood pressure, and Ramsey scale', 'visual analogue scale']","[{'cui': 'C1096288', 'cui_str': 'Perioperative analgesia'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027348', 'cui_str': 'Nalbuphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",68.0,0.071397,"The average visual analogue scale was 2.9 and 3 ( p = 0.65) in groups 1 (experimental) and 2 (control), respectively.","[{'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Bryniarski', 'Affiliation': 'Department of Urology in Zabrze, Faculty of Medical Sciences in Zabrze, Medical University of Silesia in Katowice, 40-055 Katowice, Poland.'}, {'ForeName': 'Szymon', 'Initials': 'S', 'LastName': 'Bialka', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Emergency Medicine, Faculty of Medical Sciences in Zabrze, Medical University of Silesia in Katowice, 40-055 Katowice, Poland.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kepinski', 'Affiliation': 'Department of Urology in Zabrze, Faculty of Medical Sciences in Zabrze, Medical University of Silesia in Katowice, 40-055 Katowice, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Szelka-Urbanczyk', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Emergency Medicine, Faculty of Medical Sciences in Zabrze, Medical University of Silesia in Katowice, 40-055 Katowice, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Paradysz', 'Affiliation': 'Department of Urology in Zabrze, Faculty of Medical Sciences in Zabrze, Medical University of Silesia in Katowice, 40-055 Katowice, Poland.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Misiolek', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Emergency Medicine, Faculty of Medical Sciences in Zabrze, Medical University of Silesia in Katowice, 40-055 Katowice, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph18073625'] 2781,33807285,Effectiveness of an Intervention Aimed at Improving Information for Patients with High Cardiovascular Risk: INFORISK Clinical Trial.,"BACKGROUND The concept of global cardiovascular risk is not usually well understood by patients in consultation. METHODS This was a multicenter, prospective, randomized, open clinical trial of one-year duration to evaluate the effectiveness in reducing global cardiovascular risk with an intervention aimed at high-risk patients to improve information on the cardiovascular risk compared to the usual care. The intervention was focused on providing information about cardiovascular risk in a more understandable way, explaining the best practices to reduce cardiovascular risk, and tailoring information to the individual. RESULTS Four-hundred and sixty-four subjects participated in the study; 59.3% were men, and the mean age was 61.0 (SD 8.0) years. Significant reductions in systolic blood pressure (SBP) (-3.12 mmHg), body mass index (BMI) (-0.34 kg/m 2 ), abdominal circumference (-1.24 cm), and REGICOR cardiovascular risk (-0.63) were observed in the intervention group. Overall, no differences in cardiovascular risk score were observed between groups at the end of follow-up. CONCLUSIONS Providing an easy-to-understand assessment of the cardiovascular risk motivated high-risk patients to adopt a healthier lifestyle and improved cardiovascular risk after one year in the intervention group. Clinicians should assess a patient's baseline understanding of their CV risk using tools other than absolute risk before making treatment recommendations.",2021,"Significant reductions in systolic blood pressure (SBP) (-3.12 mmHg), body mass index (BMI) (-0.34 kg/m 2 ), abdominal circumference (-1.24 cm), and REGICOR cardiovascular risk (-0.63) were observed in the intervention group.","['Four-hundred and sixty-four subjects participated in the study; 59.3% were men, and the mean age was 61.0 (SD 8.0) years', 'Patients with High Cardiovascular Risk']",[],"['global cardiovascular risk', 'abdominal circumference', 'systolic blood pressure (SBP) (-3.12 mmHg), body mass index (BMI', 'cardiovascular risk', 'cardiovascular risk score']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",[],"[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",464.0,0.0663189,"Significant reductions in systolic blood pressure (SBP) (-3.12 mmHg), body mass index (BMI) (-0.34 kg/m 2 ), abdominal circumference (-1.24 cm), and REGICOR cardiovascular risk (-0.63) were observed in the intervention group.","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Brotons', 'Affiliation': 'EAP Sardenya-IIB Sant Pau, 08025 Barcelona, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Moral', 'Affiliation': 'EAP Sardenya-IIB Sant Pau, 08025 Barcelona, Spain.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Fernández', 'Affiliation': 'EAP Sardenya-IIB Sant Pau, 08025 Barcelona, Spain.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Puig', 'Affiliation': 'EAP Sardenya-IIB Sant Pau, 08025 Barcelona, Spain.'}, {'ForeName': 'M Teresa', 'Initials': 'MT', 'LastName': 'Vilella', 'Affiliation': 'EAP Sardenya-IIB Sant Pau, 08025 Barcelona, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Puig', 'Affiliation': 'Epidemiology Department, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, CIBER Cardiovascular, IIB Sant Pau, 08041 Barcelona, Spain.'}, {'ForeName': 'LLuís', 'Initials': 'L', 'LastName': 'Cuixart', 'Affiliation': ""EAP Dreta de l'Eixample, 08013 Barcelona, Spain.""}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Férriz', 'Affiliation': 'ABS Sagrada Familia, 08017 Barcelona, Spain.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Pedro', 'Affiliation': 'ABS Gaudí, 08017 Barcelona, Spain.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Codinachs', 'Affiliation': 'EAP Vic Sud, 08500 Vic, Spain.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Rodríguez', 'Affiliation': 'CAP Pare Claret, 08037 Barcelona, Spain.'}, {'ForeName': 'Rubén', 'Initials': 'R', 'LastName': 'Fuentes', 'Affiliation': 'EAP Sardenya-IIB Sant Pau, 08025 Barcelona, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': 'On Behalf Of Inforisk Study Investigators', 'Affiliation': ''}]",International journal of environmental research and public health,['10.3390/ijerph18073621'] 2782,33807284,Time-Restricted Eating for 12 Weeks Does Not Adversely Alter Bone Turnover in Overweight Adults.,"Weight loss is a major focus of research and public health efforts. Time-restricted eating (TRE) is shown to be effective for weight loss, but the impact on bone is unclear. Short-term TRE studies show no effect on bone mineral density (BMD), but no study has measured bone turnover markers. This secondary analysis examined the effect of 12 weeks of TRE vs. unrestricted eating on bone turnover and BMD. Overweight and obese adults aged 18-65 y ( n = 20) were randomized to TRE (ad libitum 8-h eating window) or non-TRE. Serum N-terminal propeptide of type I collagen (P1NP), cross-linked N-telopeptide of type I collagen (NTX), and parathyroid hormone (PTH) levels were measured and dual-energy X-ray absorptiometry (DXA) scans were taken pre- and post-intervention. In both groups, P1NP decreased significantly ( p = 0.04) but trended to a greater decrease in the non-TRE group ( p = 0.07). The treatment time interaction for bone mineral content (BMC) was significant ( p = 0.02), such that BMC increased in the TRE group and decreased in the non-TRE group. Change in P1NP was inversely correlated with change in weight ( p = 0.04) overall, but not within each group. These findings suggest that TRE does not adversely affect bone over a moderate timeframe. Further research should examine the long-term effects of TRE on bone.",2021,"In both groups, P1NP decreased significantly ( p = 0.04) but trended to a greater decrease in the non-TRE group ( p = 0.07).","['Overweight Adults', 'Overweight and obese adults aged 18-65 y ( n = 20']","['I collagen (P1NP', 'TRE', 'Time-restricted eating (TRE', 'TRE vs. unrestricted eating', 'TRE (ad libitum 8-h eating window) or non-TRE']","['P1NP', 'Serum N-terminal propeptide of type', 'Weight loss', 'bone mineral content (BMC', 'Change in P1NP', 'change in weight', 'I collagen (NTX), and parathyroid hormone (PTH) levels', 'bone mineral density (BMD', 'Bone Turnover', 'bone turnover and BMD', 'BMC']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0557702', 'cui_str': 'Window'}]","[{'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}]",20.0,0.0142476,"In both groups, P1NP decreased significantly ( p = 0.04) but trended to a greater decrease in the non-TRE group ( p = 0.07).","[{'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Lobene', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, IN 47907, USA.'}, {'ForeName': 'Satchidananda', 'Initials': 'S', 'LastName': 'Panda', 'Affiliation': 'Salk Institute for Biological Studies, La Jolla, CA 92037, USA.'}, {'ForeName': 'Douglas G', 'Initials': 'DG', 'LastName': 'Mashek', 'Affiliation': 'Department of Biochemistry, Molecular Biology and Biophysics, University of Minnesota, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Emily N C', 'Initials': 'ENC', 'LastName': 'Manoogian', 'Affiliation': 'Salk Institute for Biological Studies, La Jolla, CA 92037, USA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Hill Gallant', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, IN 47907, USA.'}, {'ForeName': 'Lisa S', 'Initials': 'LS', 'LastName': 'Chow', 'Affiliation': 'Department of Medicine, Division of Diabetes, Endocrinology and Metabolism, University of Minnesota, Minneapolis, MN 55455, USA.'}]",Nutrients,['10.3390/nu13041155'] 2783,33806822,"Effects of a Short-Term ""Fat Adaptation with Carbohydrate Restoration"" Diet on Metabolic Responses and Exercise Performance in Well-Trained Runners.","Periodized carbohydrate availability can enhance exercise capacity, but the effects of short-term fat adaptation carbohydrate restoration (FACR) diets on metabolic responses and exercise performance in endurance athletes have not been conclusively determined. This study aimed to investigate the effect of a FACR diet on measures of resting metabolism, exercise metabolism, and exercise performance. Well-trained male runners ( n = 8) completed a FACR dietary intervention (five days' carbohydrate < 20% and fat > 60% energy, plus one-day carbohydrate ≥ 70% energy), and a control high-carbohydrate (HCHO) diet for six days (carbohydrate > 60% energy; fat < 20% energy) in a randomized crossover design. Pre- and post-intervention metabolic measures included resting metabolic rate (RMR), respiratory quotient (RQ), maximum fat oxidation rate during exercise (MFO), and maximum fat oxidation intensity (FATmax). Measures of exercise performance included maximal oxygen uptake (VO 2 max), running economy (RE), and 5 km running time trial (5 km-TT). In FACR compared with HCHO, there were significant improvements in FATmax ( p = 0.006) and RE ( p = 0.048). There were no significant differences ( p > 0.05) between FACR and HCHO in RMR, RQ, VO 2 max, or 5 km-TT. Findings suggest that a short-term (six days) FACR diet may facilitate increased fat oxidation and submaximal exercise economy but does not improve 5 km-TT performance.",2021,"In FACR compared with HCHO, there were significant improvements in FATmax ( p = 0.006) and RE ( p = 0.048).","['Well-Trained Runners', 'endurance athletes', 'Well-trained male runners ( n = 8) completed a']","['FACR diet', ""FACR dietary intervention (five days' carbohydrate < 20% and fat > 60% energy, plus one-day carbohydrate ≥ 70% energy), and a control high-carbohydrate (HCHO) diet for six days (carbohydrate > 60% energy; fat < 20% energy"", 'adaptation carbohydrate restoration (FACR) diets', 'Short-Term ""Fat Adaptation with Carbohydrate Restoration"" Diet']","['FACR and HCHO in RMR, RQ, VO 2 max, or 5 km-TT', 'fat oxidation and submaximal exercise economy', 'Metabolic Responses and Exercise Performance', 'metabolic responses and exercise performance', 'resting metabolic rate (RMR), respiratory quotient (RQ), maximum fat oxidation rate during exercise (MFO), and maximum fat oxidation intensity (FATmax', 'maximal oxygen uptake (VO 2 max), running economy (RE), and 5 km running time trial (5 km-TT', 'FATmax', 'resting metabolism, exercise metabolism, and exercise performance']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0259835', 'cui_str': 'High carbohydrate diet'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",,0.0111224,"In FACR compared with HCHO, there were significant improvements in FATmax ( p = 0.006) and RE ( p = 0.048).","[{'ForeName': 'Kaixuan', 'Initials': 'K', 'LastName': 'Che', 'Affiliation': 'Department of Exercise Biochemistry, Exercise Science School, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Junqiang', 'Initials': 'J', 'LastName': 'Qiu', 'Affiliation': 'Department of Exercise Biochemistry, Exercise Science School, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Longyan', 'Initials': 'L', 'LastName': 'Yi', 'Affiliation': 'Department of Exercise Biochemistry, Exercise Science School, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Menghui', 'Initials': 'M', 'LastName': 'Zou', 'Affiliation': 'China Athletics School, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Zhihui', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Exercise Biochemistry, Exercise Science School, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Carr', 'Affiliation': 'Centre for Sport Research, Faculty of Health, Deakin University, Melbourne, VIC 3125, Australia.'}, {'ForeName': 'Rhiannon M J', 'Initials': 'RMJ', 'LastName': 'Snipe', 'Affiliation': 'Centre for Sport Research, Faculty of Health, Deakin University, Melbourne, VIC 3125, Australia.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Benardot', 'Affiliation': 'Department of Nutrition, Georgia State University, Atlanta, GA 30303, USA.'}]",Nutrients,['10.3390/nu13031033'] 2784,33806669,Change in Exercise Performance and Markers of Acute Kidney Injury Following Heat Acclimation with Permissive Dehydration.,"Implementing permissive dehydration (DEH) during short-term heat acclimation (HA) may accelerate adaptations to the heat. However, HA with DEH may augment risk for acute kidney injury (AKI). This study investigated the effect of HA with permissive DEH on time-trial performance and markers of AKI. Fourteen moderately trained men (age and VO 2max = 25 ± 0.5 yr and 51.6 ± 1.8 mL . kg -1 . min -1 ) were randomly assigned to DEH or euhydration (EUH). Time-trial performance and VO 2max were assessed in a temperate environment before and after 7 d of HA. Heat acclimation consisted of 90 min of cycling in an environmental chamber (40 °C, 35% RH). Neutrophil gelatinase-associated lipocalin (NGAL) and kidney injury molecule-1 (KIM-1) were assessed pre- and post-exercise on day 1 and day 7 of HA. Following HA, VO 2max did not change in either group ( p = 0.099); however, time-trial performance significantly improved (3%, p < 0.01) with no difference between groups ( p = 0.485). Compared to pre-exercise, NGAL was not significantly different following day 1 and 7 of HA ( p = 0.113) with no difference between groups ( p = 0.667). There was a significant increase in KIM-1 following day 1 and 7 of HA ( p = 0.002) with no difference between groups ( p = 0.307). Heat acclimation paired with permissive DEH does not amplify improvements in VO 2max or time-trial performance in a temperate environment versus EUH and does not increase markers of AKI.",2021,There was a significant increase in KIM-1 following day 1 and 7 of HA ( p = 0.002) with no difference between groups ( p = 0.307).,['Fourteen moderately trained men (age and VO 2max = 25 ± 0.5 yr and 51.6 ± 1.8 mL '],"['Implementing permissive dehydration (DEH) during short-term heat acclimation (HA', 'DEH or euhydration (EUH', 'HA with DEH', 'Heat Acclimation with Permissive Dehydration', 'HA with permissive DEH']","['VO 2max or time-trial performance', 'time-trial performance', 'KIM-1', 'Time-trial performance and VO 2max', 'Neutrophil gelatinase-associated lipocalin (NGAL) and kidney injury molecule-1 (KIM-1', 'time-trial performance and markers of AKI']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C4068742', 'cui_str': '1.8'}]","[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1313407', 'cui_str': 'HAVCR1 protein, human'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0206528', 'cui_str': 'Gelatinase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1956074', 'cui_str': 'Lipocalin'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}]",14.0,0.101328,There was a significant increase in KIM-1 following day 1 and 7 of HA ( p = 0.002) with no difference between groups ( p = 0.307).,"[{'ForeName': 'Arpie', 'Initials': 'A', 'LastName': 'Haroutounian', 'Affiliation': 'School of Kinesiology, Nutrition, and Food Science, California State University, Los Angeles, Los Angeles, CA 90032, USA.'}, {'ForeName': 'Fabiano T', 'Initials': 'FT', 'LastName': 'Amorim', 'Affiliation': 'Department of Health, Exercise, and Sports Sciences, University of New Mexico, Albuquerque, NM 87131, USA.'}, {'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Astorino', 'Affiliation': 'Department of Kinesiology, California State University, San Marcos, San Marcos, CA 92096, USA.'}, {'ForeName': 'Nazareth', 'Initials': 'N', 'LastName': 'Khodiguian', 'Affiliation': 'School of Kinesiology, Nutrition, and Food Science, California State University, Los Angeles, Los Angeles, CA 90032, USA.'}, {'ForeName': 'Katharine M', 'Initials': 'KM', 'LastName': 'Curtiss', 'Affiliation': 'School of Kinesiology, Nutrition, and Food Science, California State University, Los Angeles, Los Angeles, CA 90032, USA.'}, {'ForeName': 'Aaron R D', 'Initials': 'ARD', 'LastName': 'Matthews', 'Affiliation': 'School of Kinesiology, Nutrition, and Food Science, California State University, Los Angeles, Los Angeles, CA 90032, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Estrada', 'Affiliation': 'School of Kinesiology, Nutrition, and Food Science, California State University, Los Angeles, Los Angeles, CA 90032, USA.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Fennel', 'Affiliation': 'Department of Health, Exercise, and Sports Sciences, University of New Mexico, Albuquerque, NM 87131, USA.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'McKenna', 'Affiliation': 'Department of Health, Exercise, and Sports Sciences, University of New Mexico, Albuquerque, NM 87131, USA.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Nava', 'Affiliation': 'Department of Health, Exercise, and Sports Sciences, University of New Mexico, Albuquerque, NM 87131, USA.'}, {'ForeName': 'Ailish C', 'Initials': 'AC', 'LastName': 'Sheard', 'Affiliation': 'School of Kinesiology, Nutrition, and Food Science, California State University, Los Angeles, Los Angeles, CA 90032, USA.'}]",Nutrients,['10.3390/nu13030841'] 2785,33806257,The Combined Effects of Obesity and Cardiorespiratory Fitness Are Associated with Response Inhibition: An ERP Study.,"Obesity and cardiorespiratory fitness exhibit negative and positive impacts, respectively, on executive function. Nevertheless, the combined effects of these two factors on executive function remain unclear. This study investigated the combined effects of obesity and cardiorespiratory fitness on response inhibition of executive function from both behavioral and neuroelectric perspectives. Ninety-six young adults aged between 18 and 25 years were recruited and assigned into four groups: the high cardiorespiratory fitness with normal weight (NH), high cardiorespiratory fitness with obesity (OH), low cardiorespiratory fitness with normal weight (NL), and low cardiorespiratory fitness with obesity (OL) groups. The stop-signal task and its induced P3 component of event-related potentials was utilized to index response inhibition. The participants with higher cardiorespiratory fitness (i.e., the NH and OH groups) demonstrated better behavioral performance (i.e., shorter response times and higher accuracy levels), as well as shorter stop-signal response times and larger P3 amplitudes than their counterparts with low cardiorespiratory fitness (i.e., the NL and OL groups). The study provides first-hand evidence of the substantial effects of cardiorespiratory fitness on the response inhibition, including evidence that the detrimental effects of obesity might be overcome by high cardiorespiratory fitness.",2021,"The participants with higher cardiorespiratory fitness (i.e., the NH and OH groups) demonstrated better behavioral performance (i.e., shorter response times and higher accuracy levels), as well as shorter stop-signal response times and larger P3 amplitudes than their counterparts with low cardiorespiratory fitness (i.e., the NL and OL groups).",['Ninety-six young adults aged between 18 and 25 years'],"['high cardiorespiratory fitness with normal weight (NH), high cardiorespiratory fitness with obesity (OH), low cardiorespiratory fitness with normal weight (NL), and low cardiorespiratory fitness with obesity (OL) groups']","['behavioral performance', 'shorter stop-signal response times and larger P3 amplitudes']","[{'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0549177', 'cui_str': 'Large'}]",96.0,0.0338714,"The participants with higher cardiorespiratory fitness (i.e., the NH and OH groups) demonstrated better behavioral performance (i.e., shorter response times and higher accuracy levels), as well as shorter stop-signal response times and larger P3 amplitudes than their counterparts with low cardiorespiratory fitness (i.e., the NL and OL groups).","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Chi', 'Affiliation': 'School of Physical Education, Minnan Normal University, Zhangzhou 363000, Fujian, China.'}, {'ForeName': 'Chiao-Ling', 'Initials': 'CL', 'LastName': 'Hung', 'Affiliation': 'Department of Athletics, National Taiwan University, Taipei 106319, Taiwan.'}, {'ForeName': 'Chi-Yen', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Physical Education Office, National Taiwan Ocean University, Keelung 202301, Taiwan.'}, {'ForeName': 'Tai-Fen', 'Initials': 'TF', 'LastName': 'Song', 'Affiliation': 'Department of Sport Performance, National Taiwan University of Sport, Taichung 404401, Taiwan.'}, {'ForeName': 'Chien-Heng', 'Initials': 'CH', 'LastName': 'Chu', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei 106209, Taiwan.'}, {'ForeName': 'Yu-Kai', 'Initials': 'YK', 'LastName': 'Chang', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei 106209, Taiwan.'}, {'ForeName': 'Chenglin', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'School of Psychology, Shanghai University of Sport, Shanghai 200438, China.'}]",International journal of environmental research and public health,['10.3390/ijerph18073429'] 2786,33806189,Evaluation of Quality of Life and Satisfaction in Patients with Fixed Prostheses on Zygomatic Implants Compared with the All-on-Four Concept: A Prospective Randomized Clinical Study.,"Purpose : No published research has compared patients' quality of life and satisfaction with fixed prostheses supported by zygomatic implants with those supported by all-on-four prostheses. The aim of this study was to evaluate patients' quality of life and satisfaction with fixed prostheses on zygomatic implants compared with the all-on-four concept. Materials and Methods : A total of 80 patients with atrophic edentulous maxillae were randomized into two groups: Group 1 (rehabilitated with fixed prostheses supported by 2-4 zygomatic and 2-4 conventional implants in the anterior region) and Group 2 (fixed prostheses on four implants in the anterior region following an all-on-four concept). One year after placement of the definitive prostheses, patients completed OHIP-14 and satisfaction questionnaires. Results : In all seven domains of the OHIP-14 and in the overall scores, a worse quality of life was found in Group 2 patients, with statistically significant differences between the two groups ( p ≤ 0.05). Patients with zygomatic implants were more satisfied with their prostheses, with a statistically significant difference ( p < 0.001). Conclusions : According to the results of this study, rehabilitation of patients with edentulous atrophic maxillae with prostheses supported by zygomatic implants combined with anterior implants provided better patient quality of life and satisfaction than prostheses supported by four implants.",2021,"In all seven domains of the OHIP-14 and in the overall scores, a worse quality of life was found in Group 2 patients, with statistically significant differences between the two groups ( p ≤ 0.05).","['80 patients with atrophic edentulous maxillae', 'Patients with Fixed Prostheses on Zygomatic Implants', 'patients with edentulous atrophic maxillae with prostheses supported by', 'Patients with zygomatic implants']","['Materials and Methods ', 'Group 1 (rehabilitated with fixed prostheses supported by 2-4 zygomatic and 2-4 conventional implants in the anterior region) and Group 2 (fixed prostheses on four implants in the anterior region following an all-on-four concept', 'zygomatic implants combined with anterior implants']","['patient quality of life and satisfaction', 'quality of life', 'OHIP-14 and satisfaction questionnaires', ""patients' quality of life and satisfaction"", 'Quality of Life and Satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0020671', 'cui_str': 'Structure of supraoptic region of hypothalamus'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",80.0,0.0314275,"In all seven domains of the OHIP-14 and in the overall scores, a worse quality of life was found in Group 2 patients, with statistically significant differences between the two groups ( p ≤ 0.05).","[{'ForeName': 'Juan Alberto', 'Initials': 'JA', 'LastName': 'Fernández-Ruiz', 'Affiliation': 'Clinica Fernández, 07800 Ibiza, Spain.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Sánchez-Siles', 'Affiliation': 'Clínica Dental Puerta Nueva, 30001 Murcia, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Guerrero-Sánchez', 'Affiliation': 'Department of Anatomy and Psychobiology, University of Murcia, 30100 Murcia, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Pato-Mourelo', 'Affiliation': 'Galimplant, 27600 Sarria (Lugo), Spain.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Camacho-Alonso', 'Affiliation': 'Department of Oral Surgery, University of Murcia, 30100 Murcia, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph18073426'] 2787,33806089,Effect of 4 Weeks of Cervical Deep Muscle Flexion Exercise on Headache and Sleep Disorder in Patients with Tension Headache and Forward Head Posture.,"The purpose of this study was to investigate the effect of flexion exercise of the deep cervical muscles on headache and sleep disorders in patients with tension headaches and forward head posture. A total of 32 patients with tension headaches and forward head posture were randomly assigned to two groups: an experimental group ( n = 16) and a control group ( n = 16). The experimental group performed cervical deep muscle flexion exercises for 4 weeks, whereas the control group performed stretching exercises for the same period. The Henry Ford Hospital Headache Disability Inventory (HDI) was used for headache assessment, and the Korean version of the Pittsburgh Sleep Quality Index (PSQI-K) was used for sleep disorder assessment. The experimental group showed a significant reduction in both HDI and PSQI-K score after 4 weeks of intervention ( p < 0.001), while no significant difference was found in the control group ( p > 0.05). On comparing the experimental and control groups, we found a significant difference in changes in the HDI and PSQI-K between the groups ( p < 0.05). The results indicate that flexion exercise of the deep cervical muscles in patients with tension headache and forward head posture will improve the quality of life and activities of daily life by mitigating headaches and sleep disorders.",2021,"The experimental group showed a significant reduction in both HDI and PSQI-K score after 4 weeks of intervention ( p < 0.001), while no significant difference was found in the control group ( p > 0.05).","['32 patients with tension headaches and forward head posture', 'patients with tension headaches and forward head posture', 'Patients with Tension Headache and Forward Head Posture', 'patients with tension headache']","['control group performed stretching exercises', 'flexion exercise', 'Cervical Deep Muscle Flexion Exercise', 'cervical deep muscle flexion exercises']","['quality of life and activities of daily life', 'HDI and PSQI-K', 'Korean version of the Pittsburgh Sleep Quality Index (PSQI-K', 'headache and sleep disorders', 'HDI and PSQI-K score', 'Henry Ford Hospital Headache Disability Inventory (HDI', 'Headache and Sleep Disorder']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033893', 'cui_str': 'Psychogenic headache'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C1536116', 'cui_str': 'Head posture abnormal'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582517', 'cui_str': 'henry'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",32.0,0.0144144,"The experimental group showed a significant reduction in both HDI and PSQI-K score after 4 weeks of intervention ( p < 0.001), while no significant difference was found in the control group ( p > 0.05).","[{'ForeName': 'Wonho', 'Initials': 'W', 'LastName': 'Choi', 'Affiliation': 'Department of Physical Therapy, Gachon University, Incheon 21936, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph18073410'] 2788,33806051,Health Care Services Utilization and Health-Related Quality of Life of Syrian Refugees with Post-Traumatic Stress Symptoms in Germany (the Sanadak Trial).,"Refugees who have fled from the ongoing civil war in Syria that arrived in Germany often develop post-traumatic stress symptoms (PTSS). The aim of this study was to determine health care services utilization (HCSU), health care costs and health-related quality of life (HrQoL) of Syrian refugees with mild to moderate PTSS without current treatment in Germany. The study was based on the baseline sample of a randomized controlled trial of a self-help app for Syrian refugees with PTSS ( n = 133). HCSU and HrQoL based on the EQ-5D-5L and its visual analogue scale (EQ-VAS) were assessed with standardized interviews. Annual health care costs were calculated using extrapolated four-month HCSU and standardized unit costs. Associations between health care costs, HrQoL and PTSS severity were examined using generalized linear models. Overall, 85.0% of the sample utilized health care services within four months. The mean total annual health care costs were EUR 1920 per person. PTSS severity was not associated with health care costs. The EQ-5D-5L index score and the EQ-VAS score was 0.82 and 73.6, respectively. For Syrian refugees with higher PTSS severity, the EQ-5D-5L index score was lower (-0.17; p < 0.001). The HCSU and the resulting health care costs of Syrian refugees with mild to moderate PTSS without current treatment are low and those with a higher PTSS severity had a lower HrQoL.",2021,"For Syrian refugees with higher PTSS severity, the EQ-5D-5L index score was lower (-0.17; ","['Syrian refugees with PTSS ( n = 133', 'Syrian refugees with mild to moderate PTSS without current treatment in Germany']",[],"['mean total annual health care costs', 'health care costs, HrQoL and PTSS severity', 'EQ-5D-5L index score', 'health care services utilization (HCSU), health care costs and health-related quality of life (HrQoL', 'Annual health care costs', 'EQ-5D-5L index score and the EQ-VAS score', 'HCSU and HrQoL based on the EQ-5D-5L and its visual analogue scale (EQ-VAS']","[{'cui': 'C0018561', 'cui_str': 'Mesocricetus auratus'}, {'cui': 'C0034961', 'cui_str': 'Refugee'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",,0.0579523,"For Syrian refugees with higher PTSS severity, the EQ-5D-5L index score was lower (-0.17; ","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Grochtdreis', 'Affiliation': 'Department of Health Economics and Health Services Research, Hamburg Center for Health Economics, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Röhr', 'Affiliation': 'Institute of Social Medicine, Occupational Health and Public Health (ISAP), Medical Faculty, University of Leipzig, 04103 Leipzig, Germany.'}, {'ForeName': 'Franziska U', 'Initials': 'FU', 'LastName': 'Jung', 'Affiliation': 'Institute of Social Medicine, Occupational Health and Public Health (ISAP), Medical Faculty, University of Leipzig, 04103 Leipzig, Germany.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Nagl', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Leipzig, 04103 Leipzig, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Renner', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Leipzig, 04103 Leipzig, Germany.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Kersting', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Leipzig, 04103 Leipzig, Germany.'}, {'ForeName': 'Steffi G', 'Initials': 'SG', 'LastName': 'Riedel-Heller', 'Affiliation': 'Institute of Social Medicine, Occupational Health and Public Health (ISAP), Medical Faculty, University of Leipzig, 04103 Leipzig, Germany.'}, {'ForeName': 'Hans-Helmut', 'Initials': 'HH', 'LastName': 'König', 'Affiliation': 'Department of Health Economics and Health Services Research, Hamburg Center for Health Economics, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Dams', 'Affiliation': 'Department of Health Economics and Health Services Research, Hamburg Center for Health Economics, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246 Hamburg, Germany.'}]",International journal of environmental research and public health,['10.3390/ijerph18073408'] 2789,33805501,A Participatory Intervention to Improve the Psychosocial Work Environment and Mental Health in Human Service Organisations. A Mixed Methods Evaluation Study.,"Work-related stress is a global problem causing suffering and economic costs. In Sweden, employees in human service occupations are overrepresented among persons on sick leave due to mental health problems such as stress-related disorders. The psychosocial work environment is one contributing factor for this problem, making it urgent to identify effective methods to decrease stress at the workplace. The aim of the study is to evaluate a participatory intervention to improve the psychosocial work environment and mental health using an embedded mixed methods design. The study is a controlled trial with a parallel process evaluation exploring fidelity and participants' reactions to the intervention activities, experiences of learning and changes in behaviours and work routines. We collected data through documentation, interviews and three waves of questionnaires. Our results show small changes in behaviours and work routines and no positive effects of the intervention on the psychosocial work environment nor health outcomes. One explanation is end-users' perceived lack of involvement over the process causing the intervention to be seen as a burden. Another explanation is that the intervention activities were perceived targeting the wrong organisational level. A representative participation over both content and process can be an effective strategy to change psychosocial working conditions and mental health.",2021,Our results show small changes in behaviours and work routines and no positive effects of the intervention on the psychosocial work environment nor health outcomes.,['Human Service Organisations'],['participatory intervention'],[],"[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0029237', 'cui_str': 'Organization'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0548445,Our results show small changes in behaviours and work routines and no positive effects of the intervention on the psychosocial work environment nor health outcomes.,"[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Cedstrand', 'Affiliation': 'Institute for Environmental Medicine, Karolinska Institutet, Unit of Occupational Medicine, 171 77 Stockholm, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Nyberg', 'Affiliation': 'Institute for Environmental Medicine, Karolinska Institutet, Unit of Occupational Medicine, 171 77 Stockholm, Sweden.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Sanchez-Bengtsson', 'Affiliation': 'Center of Occupational and Environmental Medicine, Stockholm Region, 113 65 Stockholm, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Alderling', 'Affiliation': 'Institute for Environmental Medicine, Karolinska Institutet, Unit of Occupational Medicine, 171 77 Stockholm, Sweden.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Augustsson', 'Affiliation': 'Medical Management Centre, Procome Research Group, Department of Learning, Informatics, Management and Ethics, Karolinska Institutet, 171 77 Stockholm, Sweden.'}, {'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'Bodin', 'Affiliation': 'Institute for Environmental Medicine, Karolinska Institutet, Unit of Occupational Medicine, 171 77 Stockholm, Sweden.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Mölsted Alvesson', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, 171 77 Stockholm, Sweden.'}, {'ForeName': 'Gun', 'Initials': 'G', 'LastName': 'Johansson', 'Affiliation': 'Institute for Environmental Medicine, Karolinska Institutet, Unit of Occupational Medicine, 171 77 Stockholm, Sweden.'}]",International journal of environmental research and public health,['10.3390/ijerph18073546'] 2790,33805484,The Effect of Multiprobiotics on Memory and Attention in Fibromyalgia: A Pilot Randomized Controlled Trial.,"Fibromyalgia syndrome (FMS) is a chronic, generalized and diffuse pain disorder accompanied by cognitive deficits such as forgetfulness, concentration difficulties, loss of vocabulary and mental slowness, among others. In recent years, FMS has been associated with altered intestinal microbiota, suggesting that modulating gut microbiota (for example, through probiotics) could be an effective therapeutic treatment. Thus, the aim of the present study was to continue exploring the role of probiotics in cognitive processes in patients with FMS. A pilot randomized controlled trial was conducted in 31 patients diagnosed with FMS to compare the effects of a multispecies probiotic versus a placebo on cognitive variables (memory and attention) after eight weeks. Results showed that treatment with a multispecies probiotic produced an improvement in attention by reducing errors on an attention task, but it had no effect on memory. More specifically, a tendency to reduce errors of omission (Go trials) during the Go/No-Go Task was observed after treatment. These findings, along with our previous results in impulsivity, underline the relevance of using probiotics as a therapeutic option in FMS, although more research with a larger sample size is required.",2021,"Results showed that treatment with a multispecies probiotic produced an improvement in attention by reducing errors on an attention task, but it had no effect on memory.","['Fibromyalgia syndrome (FMS', 'Fibromyalgia', 'patients with FMS', '31 patients diagnosed with FMS']","['multispecies probiotic versus a placebo', 'Multiprobiotics']","['memory', 'attention by reducing errors on an attention task', 'cognitive variables (memory and attention']","[{'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",31.0,0.101595,"Results showed that treatment with a multispecies probiotic produced an improvement in attention by reducing errors on an attention task, but it had no effect on memory.","[{'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Cardona', 'Affiliation': 'Department of Nursing, Physiotherapy and Medicine, Health Research Center (CEINSA), University of Almeria, 04120 Almeria, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Roman', 'Affiliation': 'Department of Nursing, Physiotherapy and Medicine, Health Research Center (CEINSA), University of Almeria, 04120 Almeria, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Cañadas', 'Affiliation': 'Department of Psychology, University of Almeria, 04120 Almeria, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Sánchez-Labraca', 'Affiliation': 'Department of Nursing, Physiotherapy and Medicine, Health Research Center (CEINSA), University of Almeria, 04120 Almeria, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph18073543'] 2791,33804915,The Effects of Insole-Based Visual Feedback on Weight-Bearing in Patients Undergoing Total Hip Replacement.,"This study aimed to investigate the visual biofeedback effect of a sensorized system for plantar pressure dynamic evaluation of in patients with a total hip replacement. Experimental group followed the rehabilitation training wearing sensorized insoles that provided images on three monitors. The control group followed the verbal instructions of physiotherapists during training. Weight bearing percentage healthy limb (WBPH), weight bearing percentage surgical limb (WBPS), swing healthy limb (SWH) and swing surgical limb (SWS) improved significantly more in the experimental group. The results underline the effectiveness of visual biofeedback based on sensorized system with dynamic evaluation of the plantar pressure.",2021,The results underline the effectiveness of visual biofeedback based on sensorized system with dynamic evaluation of the plantar pressure.,"['Patients Undergoing Total Hip Replacement', 'patients with a total hip replacement']","['Insole-Based Visual Feedback', 'rehabilitation training wearing sensorized insoles that provided images on three monitors', 'visual biofeedback', 'sensorized system', 'verbal instructions of physiotherapists during training']","['Weight bearing percentage healthy limb (WBPH), weight bearing percentage surgical limb (WBPS), swing healthy limb (SWH) and swing surgical limb (SWS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C3873740', 'cui_str': 'Insole'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}]","[{'cui': 'C0085086', 'cui_str': 'Weight-bearing'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]",,0.00956823,The results underline the effectiveness of visual biofeedback based on sensorized system with dynamic evaluation of the plantar pressure.,"[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Marin', 'Affiliation': 'Department of Rehabilitation, Faculty of Medicine, University of Ostrava, 70103 Ostrava, Czech Republic.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Vandoni', 'Affiliation': 'Laboratory of Adapted Motor Activity (LAMA), Department of Public Health, Experimental and Forensic Medicine, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Zaza', 'Affiliation': 'Laboratory for Rehabilitation, Medicine and Sport (LARMS), 00100 Rome, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Febbi', 'Affiliation': 'Department of Rehabilitation, Faculty of Medicine, University of Ostrava, 70103 Ostrava, Czech Republic.'}, {'ForeName': 'Luisella', 'Initials': 'L', 'LastName': 'Pedrotti', 'Affiliation': 'Department of Pediatric Diagnostic Surgical Clinical Science, Section of Pathologies of the Musculoskeleta System, Orthopedics Unit, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Chiodaroli', 'Affiliation': 'Department of Rehabilitation, Città di Pavia Hospital, 27100 Pavia, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Lovecchio', 'Affiliation': 'Laboratory of Adapted Motor Activity (LAMA), Department of Public Health, Experimental and Forensic Medicine, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Manzoni', 'Affiliation': 'Unit of Biostatistics and Clinical Epidemiology, Department of Public Health, Experimental and Forensic Medicine, University of Pavia, 27100 Pavia, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph18073346'] 2792,33804664,Effect on Chest Compression Fraction of Continuous Manual Compressions with Asynchronous Ventilations Using an i-gel ® versus 30:2 Approach during Simulated Out-of-Hospital Cardiac Arrest: Protocol for a Manikin Multicenter Randomized Controlled Trial.,"The optimal airway management strategy during cardiopulmonary resuscitation is uncertain. In the case of out-of-hospital cardiac arrest, a high chest compression fraction is paramount to obtain the return of spontaneous circulation and improve survival and neurological outcomes. To improve this fraction, providing continuous chest compressions should be more effective than using the conventional 30:2 ratio. Airway management should, however, be adapted, since face-mask ventilation can hardly be carried out while continuous compressions are administered. The early insertion of a supraglottic device could therefore improve the chest compression fraction by allowing ventilation while maintaining compressions. This is a protocol for a multicenter, parallel, randomized simulation study. Depending on randomization, each team made up of paramedics and emergency medical technicians will manage the 10-min scenario according either to the standard approach (30 compressions with two face-mask ventilations) or to the experimental approach (continuous manual compressions with early insertion of an i-gel ® supraglottic device to deliver asynchronous ventilations). The primary outcome will be the chest compression fraction during the first two minutes of cardiopulmonary resuscitation. Secondary outcomes will be chest compression fraction (per cycle and overall), compressions and ventilations quality, time to first shock and to first ventilation, user satisfaction, and providers' self-assessed cognitive load.",2021,"Depending on randomization, each team made up of paramedics and emergency medical technicians will manage the 10-min scenario according either to the standard approach (30 compressions with two face-mask ventilations) or to the experimental approach (continuous manual compressions with early insertion of an i-gel ® supraglottic device to deliver asynchronous ventilations).",[],['standard approach (30 compressions with two face-mask ventilations) or to the experimental approach (continuous manual compressions with early insertion of an i-gel ® supraglottic device to deliver asynchronous ventilations'],"['chest compression fraction during the first two minutes of cardiopulmonary resuscitation', ""chest compression fraction (per cycle and overall), compressions and ventilations quality, time to first shock and to first ventilation, user satisfaction, and providers' self-assessed cognitive load"", 'chest compression fraction']",[],"[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0442192', 'cui_str': 'Supraglottic'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439581', 'cui_str': 'Asynchronous'}]","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",30.0,0.0291824,"Depending on randomization, each team made up of paramedics and emergency medical technicians will manage the 10-min scenario according either to the standard approach (30 compressions with two face-mask ventilations) or to the experimental approach (continuous manual compressions with early insertion of an i-gel ® supraglottic device to deliver asynchronous ventilations).","[{'ForeName': 'Loric', 'Initials': 'L', 'LastName': 'Stuby', 'Affiliation': 'Genève TEAM Ambulances, Emergency Medical Services, CH-1201 Geneva, Switzerland.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Jampen', 'Affiliation': 'ESAMB-École Supérieure de Soins Ambulanciers, College of Higher Education in Ambulance Care, CH-1231 Conches, Switzerland.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Sierro', 'Affiliation': ""Compagnie d'Ambulances de l'Hôpital du Valais, Emergency Medical Services, CH-1920 Martigny, Switzerland.""}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Paus', 'Affiliation': 'SPSL-Service de Protection et Sauvetage Lausanne, Emergency Medical Services, CH-1005 Lausanne, Switzerland.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Spichiger', 'Affiliation': 'ES ASUR, Vocational Training College for Registered Paramedics and Emergency Care, CH-1052 Le Mont-sur-Lausanne, Switzerland.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Suppan', 'Affiliation': 'Division of Emergency Medicine, Department of Anesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, University of Geneva Hospitals and Faculty of Medicine, CH-1211 Geneva, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thurre', 'Affiliation': 'Genève TEAM Ambulances, Emergency Medical Services, CH-1201 Geneva, Switzerland.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare9030354'] 2793,33578014,"Effectiveness of a multidrug therapy consisting of Ivermectin, Azithromycin, Montelukast, and Acetylsalicylic acid to prevent hospitalization and death among ambulatory COVID-19 cases in Tlaxcala, Mexico.","OBJECTIVE There is an urgent need for effective treatments to prevent or attenuate lung and systemic inflammation, endotheliitis, and thrombosis related to COVID-19. This study aimed to assess the effectiveness of a multidrug-therapy consisting of Ivermectin, Azithromycin, Montelukast, and Acetylsalicylic acid (""TNR4"" therapy) to prevent hospitalization and death among ambulatory COVID-19 cases in Tlaxcala, Mexico. DESIGN AND METHODS A comparative effectiveness study was performed among 768 confirmed SARS-CoV-2 cases aged 18-80 years, who received ambulatory care at the Ministry of Health of Tlaxcala. A total of 481 cases received the TNR4 therapy, while 287 received another treatment (comparison group). All participants received home visits and/or phone calls for clinical evaluation during the 14 days after enrollment. RESULTS Nearly 85% of cases who received the TNR4 recovered within 14 days compared to 59% in the comparison group. The likelihood of recovery within 14 days was 3.4 times greater among the TNR4 group than in the comparison group. Patients treated with TNR4 had a 75% and 81% lower risk of being hospitalized or death, respectively, than the comparison group. CONCLUSIONS TNR4 therapy improved recovery and prevented the risk of hospitalization and death among ambulatory COVID-19 cases.",2021,The likelihood of recovery within 14 days was 3.4 times greater among the TNR4 group than in the comparison group.,"['ambulatory COVID-19 cases in Tlaxcala, Mexico', '768 confirmed SARS-CoV-2 cases aged 18-80 years, who received ambulatory care at the Ministry of Health of Tlaxcala']","['TNR4 therapy', 'home visits and/or phone calls', 'TNR4', 'Ivermectin, Azithromycin, Montelukast, and Acetylsalicylic acid', 'Ivermectin, Azithromycin, Montelukast, and Acetylsalicylic acid (""TNR4"" therapy']","['risk of being hospitalized or death', 'risk of hospitalization and death', 'hospitalization and death', 'likelihood of recovery']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0298130', 'cui_str': 'montelukast'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",,0.042051,The likelihood of recovery within 14 days was 3.4 times greater among the TNR4 group than in the comparison group.,"[{'ForeName': 'René', 'Initials': 'R', 'LastName': 'Lima-Morales', 'Affiliation': 'Secretaría de Salud de Tlaxcala, Dirección General, Tlaxcala, Mexico. Electronic address: limamorales.saludtlax@gmail.com.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Méndez-Hernández', 'Affiliation': 'Secretaría de Salud de Tlaxcala, Dirección de Atención Especializada a la Salud, Tlaxcala, Mexico; Unidad de Investigación Epidemiológica y en Servicios de Salud, Delegación Morelos, Instituto Mexicano del Seguro Social, Blvd. Benito Juárez No. 31, Colonia Centro, Cuernavaca, Morelos, Mexico; Universidad Autónoma de Tlaxcala, Facultad de Ciencias de la Salud, Tlaxcala, Mexico. Electronic address: pmendezh@hotmail.com.'}, {'ForeName': 'Yvonne N', 'Initials': 'YN', 'LastName': 'Flores', 'Affiliation': 'Unidad de Investigación Epidemiológica y en Servicios de Salud, Delegación Morelos, Instituto Mexicano del Seguro Social, Blvd. Benito Juárez No. 31, Colonia Centro, Cuernavaca, Morelos, Mexico; UCLA Department of Health Policy and Management and Kaiser Permanente Center for Health Equity, Fielding School of Public Health, Los Angeles, CA, 90095, United States; UCLA Cancer Prevention and Control Research Center, Fielding School of Public Health and Jonsson Comprehensive Cancer Center, Los Angeles, CA, 90095, United States. Electronic address: yflores@jhsph.edu.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Osorno-Romero', 'Affiliation': 'Secretaría de Salud de Tlaxcala, Dirección de Atención Especializada a la Salud, Tlaxcala, Mexico. Electronic address: patubeda@hotmail.com.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cuecuecha-Rugerio', 'Affiliation': 'Secretaría de Salud de Tlaxcala, Dirección de Atención Especializada a la Salud, Tlaxcala, Mexico. Electronic address: epidemiologia_2013@hotmail.com.'}, {'ForeName': 'Adrián', 'Initials': 'A', 'LastName': 'Nava-Zamora', 'Affiliation': 'Secretaría de Salud de Tlaxcala, Dirección de Atención Especializada a la Salud, Tlaxcala, Mexico. Electronic address: adriancalidad@hotmail.com.'}, {'ForeName': 'Diego Rolando', 'Initials': 'DR', 'LastName': 'Hernández-Galdamez', 'Affiliation': 'INCAP Research Center for the Prevention of Chronic Diseases (CIIPEC), Institute of Nutrition of Central America and Panama (INCAP), Guatemala City, Guatemala. Electronic address: diego.hgz@gmail.com.'}, {'ForeName': 'Daniela Karola', 'Initials': 'DK', 'LastName': 'Romo-Dueñas', 'Affiliation': 'Red Nacional de Registros de Cáncer, Guanajuato, Mexico; Instituto de Salud Pública del estado de Guanajuato (ISAPEG), Unidad de Vigilancia Epidemiológica Hospitalaria (UVEH), Hospital General León, Guanajuato, Mexico. Electronic address: danielakarola.rd@gmail.com.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Salmerón', 'Affiliation': 'Research Center on Policies, Population, and Health. Faculty of Medicine, National Autonomous University of Mexico, Mexico City, Mexico. Electronic address: jorge.salmec@gmail.com.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2021.02.014'] 2794,33789133,Dopaminergic modulation of regional cerebral blood flow: An arterial spin labelling study of genetic and pharmacological manipulation of COMT activity.,"Dopamine has direct and complex vasoactive effects on cerebral circulation. Catechol-O-methyltransferase (COMT) regulates cortical dopamine, and its activity can be influenced both genetically and pharmacologically. COMT activity influences the functional connectivity of the PFC at rest, as well as its activity during task performance, determined using blood oxygen level-dependent (BOLD) fMRI. However, its effects on cerebral perfusion have been relatively unexplored. Here, 76 healthy males, homozygous for the functional COMT Val 158 Met polymorphism, were administered either the COMT inhibitor tolcapone or placebo in a double-blind, randomised design. We then assessed regional cerebral blood flow at rest using pulsed arterial spin labelling. Perfusion was affected by both genotype and drug. COMT genotype affected frontal regions (Val 158 > Met 158 ), whilst tolcapone influenced parietal and temporal regions (placebo > tolcapone). There was no genotype by drug interaction. Our data demonstrate that lower COMT activity is associated with lower cerebral blood flow, although the regions affected differ between those affected by genotype compared with those altered by acute pharmacological inhibition. The results extend the evidence for dopaminergic modulation of cerebral blood flow. Our findings also highlight the importance of considering vascular effects in functional neuroimaging studies, and of exercising caution in ascribing group differences in BOLD signal solely to altered neuronal activity if information about regional perfusion is not available.",2021,"COMT genotype affected frontal regions (Val 158 > Met 158 ), whilst tolcapone influenced parietal and temporal regions (placebo > tolcapone).","['76 healthy males, homozygous for the functional COMT Val 158 Met polymorphism']","['Dopamine', 'COMT inhibitor tolcapone or placebo', 'Catechol-O-methyltransferase (COMT']","['regional cerebral blood flow', 'cerebral blood flow', 'blood oxygen level-dependent (BOLD) fMRI', 'dopaminergic modulation of cerebral blood flow']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0019904', 'cui_str': 'Homozygote'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0007407', 'cui_str': 'Catechol methyltransferase'}, {'cui': 'C0042285', 'cui_str': 'Valine'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}]","[{'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0595267', 'cui_str': 'Catechol-O-methyltransferase inhibitor'}, {'cui': 'C0246330', 'cui_str': 'tolcapone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007407', 'cui_str': 'Catechol methyltransferase'}]","[{'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]",76.0,0.150051,"COMT genotype affected frontal regions (Val 158 > Met 158 ), whilst tolcapone influenced parietal and temporal regions (placebo > tolcapone).","[{'ForeName': 'Mag', 'Initials': 'M', 'LastName': 'Martens', 'Affiliation': 'Oxford Health NHS Foundation Trust, Oxford, UK; Department of Psychiatry, University of Oxford, Oxford, UK; Wellcome Centre for Integrative Neuroimaging, University of Oxford, Oxford, UK. Electronic address: Marieke.martens@psych.ox.ac.uk.'}, {'ForeName': 'Fa Kennedy', 'Initials': 'FK', 'LastName': 'McConnell', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, University of Oxford, Oxford, UK; Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford, Oxford OX1 3PJ, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Filippini', 'Affiliation': 'Oxford Health NHS Foundation Trust, Oxford, UK; Department of Psychiatry, University of Oxford, Oxford, UK; Wellcome Centre for Integrative Neuroimaging, University of Oxford, Oxford, UK; IRCCS San Camillo Hospital, Venice, Italy.'}, {'ForeName': 'C E', 'Initials': 'CE', 'LastName': 'Mackay', 'Affiliation': 'Oxford Health NHS Foundation Trust, Oxford, UK; Department of Psychiatry, University of Oxford, Oxford, UK; Wellcome Centre for Integrative Neuroimaging, University of Oxford, Oxford, UK.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Harrison', 'Affiliation': 'Oxford Health NHS Foundation Trust, Oxford, UK; Department of Psychiatry, University of Oxford, Oxford, UK; Wellcome Centre for Integrative Neuroimaging, University of Oxford, Oxford, UK.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Tunbridge', 'Affiliation': 'Oxford Health NHS Foundation Trust, Oxford, UK; Department of Psychiatry, University of Oxford, Oxford, UK.'}]",NeuroImage,['10.1016/j.neuroimage.2021.117999'] 2795,33789008,Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer.,"BACKGROUND No adjuvant treatment has been established for patients who remain at high risk for recurrence after neoadjuvant chemoradiotherapy and surgery for esophageal or gastroesophageal junction cancer. METHODS We conducted CheckMate 577, a global, randomized, double-blind, placebo-controlled phase 3 trial to evaluate a checkpoint inhibitor as adjuvant therapy in patients with esophageal or gastroesophageal junction cancer. Adults with resected (R0) stage II or III esophageal or gastroesophageal junction cancer who had received neoadjuvant chemoradiotherapy and had residual pathological disease were randomly assigned in a 2:1 ratio to receive nivolumab (at a dose of 240 mg every 2 weeks for 16 weeks, followed by nivolumab at a dose of 480 mg every 4 weeks) or matching placebo. The maximum duration of the trial intervention period was 1 year. The primary end point was disease-free survival. RESULTS The median follow-up was 24.4 months. Among the 532 patients who received nivolumab, the median disease-free survival was 22.4 months (95% confidence interval [CI], 16.6 to 34.0), as compared with 11.0 months (95% CI, 8.3 to 14.3) among the 262 patients who received placebo (hazard ratio for disease recurrence or death, 0.69; 96.4% CI, 0.56 to 0.86; P<0.001). Disease-free survival favored nivolumab across multiple prespecified subgroups. Grade 3 or 4 adverse events that were considered by the investigators to be related to the active drug or placebo occurred in 71 of 532 patients (13%) in the nivolumab group and 15 of 260 patients (6%) in the placebo group. The trial regimen was discontinued because of adverse events related to the active drug or placebo in 9% of the patients in the nivolumab group and 3% of those in the placebo group. CONCLUSIONS Among patients with resected esophageal or gastroesophageal junction cancer who had received neoadjuvant chemoradiotherapy, disease-free survival was significantly longer among those who received nivolumab adjuvant therapy than among those who received placebo. (Funded by Bristol Myers Squibb and Ono Pharmaceutical; CheckMate 577 ClinicalTrials.gov number, NCT02743494.).",2021,"BACKGROUND No adjuvant treatment has been established for patients who remain at high risk for recurrence after neoadjuvant chemoradiotherapy and surgery for esophageal or gastroesophageal junction cancer. ","['Adults with resected (R0) stage II or III esophageal or gastroesophageal junction cancer who had received neoadjuvant chemoradiotherapy and had residual pathological disease', 'patients who remain at high risk for recurrence after neoadjuvant chemoradiotherapy and surgery for esophageal or gastroesophageal junction cancer', 'patients with resected esophageal or gastroesophageal junction cancer who had received', 'patients with esophageal or gastroesophageal junction cancer', 'Resected Esophageal or Gastroesophageal Junction Cancer']","['nivolumab', 'Adjuvant Nivolumab', 'checkpoint inhibitor', 'nivolumab adjuvant therapy', 'placebo', 'nivolumab at a dose of 480 mg every 4 weeks) or matching placebo', 'neoadjuvant chemoradiotherapy']","['disease-free survival', 'median disease-free survival', 'Grade 3 or 4 adverse events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0014871', 'cui_str': 'Cardioesophageal junction structure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.886804,"BACKGROUND No adjuvant treatment has been established for patients who remain at high risk for recurrence after neoadjuvant chemoradiotherapy and surgery for esophageal or gastroesophageal junction cancer. ","[{'ForeName': 'Ronan J', 'Initials': 'RJ', 'LastName': 'Kelly', 'Affiliation': 'From the Charles A. Sammons Cancer Center at Baylor University Medical Center, Dallas (R.J.K.), and the University of Texas M.D. Anderson Cancer Center, Houston (J.A.A.); Jagiellonian University Medical College, John Paul II Hospital, Krakow, Poland (J.K., P.K.); the University Hospital Cologne, Department of Internal Medicine, Center for Integrated Oncology Aachen-Bonn-Cologne-Duesseldorf, Gastrointestinal Cancer Group Cologne, Cologne (T.Z.), and University Medical Center of Johannes Gutenberg-University Mainz (M.M.) - both in Germany; University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven (E.V.C.), and Ghent University Hospital, Ghent (K.G.) - both in Belgium; University Lille, Claude Huriez University Hospital, Lille (G.P.), and Pontchaillou University Hospital, Department of Gastroenterology, University of Rennes 1, INSERM Unité 1242, Rennes (A.L.) - both in France; Fundación Favaloro, Buenos Aires (G.M.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (J.F.); Akita University Hospital, Akita, Japan (S.M.); Duke Cancer Institute, Durham, NC (H.U.); Princess Margaret Cancer Centre, Toronto (E.E.), and Queen Elizabeth II Health Sciences Centre, Halifax, NS (S.S.) - both in Canada; the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam (C.G.); Florida Cancer Specialists and Research Institute, Fort Myers (S.Z.); University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco (A.H.K.); St. John of God Murdoch Hospital, Murdoch, WA, Australia (K.F.); Sfantul Nectarie Oncology Center, Craiova, Romania (M.S.); Bristol Myers Squibb, Princeton, NJ (J.Z., L.Z., M.L., P.S., K.K.); and Dana-Farber Cancer Institute, Boston (J.M.C.).'}, {'ForeName': 'Jaffer A', 'Initials': 'JA', 'LastName': 'Ajani', 'Affiliation': 'From the Charles A. Sammons Cancer Center at Baylor University Medical Center, Dallas (R.J.K.), and the University of Texas M.D. Anderson Cancer Center, Houston (J.A.A.); Jagiellonian University Medical College, John Paul II Hospital, Krakow, Poland (J.K., P.K.); the University Hospital Cologne, Department of Internal Medicine, Center for Integrated Oncology Aachen-Bonn-Cologne-Duesseldorf, Gastrointestinal Cancer Group Cologne, Cologne (T.Z.), and University Medical Center of Johannes Gutenberg-University Mainz (M.M.) - both in Germany; University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven (E.V.C.), and Ghent University Hospital, Ghent (K.G.) - both in Belgium; University Lille, Claude Huriez University Hospital, Lille (G.P.), and Pontchaillou University Hospital, Department of Gastroenterology, University of Rennes 1, INSERM Unité 1242, Rennes (A.L.) - both in France; Fundación Favaloro, Buenos Aires (G.M.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (J.F.); Akita University Hospital, Akita, Japan (S.M.); Duke Cancer Institute, Durham, NC (H.U.); Princess Margaret Cancer Centre, Toronto (E.E.), and Queen Elizabeth II Health Sciences Centre, Halifax, NS (S.S.) - both in Canada; the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam (C.G.); Florida Cancer Specialists and Research Institute, Fort Myers (S.Z.); University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco (A.H.K.); St. John of God Murdoch Hospital, Murdoch, WA, Australia (K.F.); Sfantul Nectarie Oncology Center, Craiova, Romania (M.S.); Bristol Myers Squibb, Princeton, NJ (J.Z., L.Z., M.L., P.S., K.K.); and Dana-Farber Cancer Institute, Boston (J.M.C.).'}, {'ForeName': 'Jaroslaw', 'Initials': 'J', 'LastName': 'Kuzdzal', 'Affiliation': 'From the Charles A. Sammons Cancer Center at Baylor University Medical Center, Dallas (R.J.K.), and the University of Texas M.D. Anderson Cancer Center, Houston (J.A.A.); Jagiellonian University Medical College, John Paul II Hospital, Krakow, Poland (J.K., P.K.); the University Hospital Cologne, Department of Internal Medicine, Center for Integrated Oncology Aachen-Bonn-Cologne-Duesseldorf, Gastrointestinal Cancer Group Cologne, Cologne (T.Z.), and University Medical Center of Johannes Gutenberg-University Mainz (M.M.) - both in Germany; University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven (E.V.C.), and Ghent University Hospital, Ghent (K.G.) - both in Belgium; University Lille, Claude Huriez University Hospital, Lille (G.P.), and Pontchaillou University Hospital, Department of Gastroenterology, University of Rennes 1, INSERM Unité 1242, Rennes (A.L.) - both in France; Fundación Favaloro, Buenos Aires (G.M.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (J.F.); Akita University Hospital, Akita, Japan (S.M.); Duke Cancer Institute, Durham, NC (H.U.); Princess Margaret Cancer Centre, Toronto (E.E.), and Queen Elizabeth II Health Sciences Centre, Halifax, NS (S.S.) - both in Canada; the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam (C.G.); Florida Cancer Specialists and Research Institute, Fort Myers (S.Z.); University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco (A.H.K.); St. John of God Murdoch Hospital, Murdoch, WA, Australia (K.F.); Sfantul Nectarie Oncology Center, Craiova, Romania (M.S.); Bristol Myers Squibb, Princeton, NJ (J.Z., L.Z., M.L., P.S., K.K.); and Dana-Farber Cancer Institute, Boston (J.M.C.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Zander', 'Affiliation': 'From the Charles A. Sammons Cancer Center at Baylor University Medical Center, Dallas (R.J.K.), and the University of Texas M.D. Anderson Cancer Center, Houston (J.A.A.); Jagiellonian University Medical College, John Paul II Hospital, Krakow, Poland (J.K., P.K.); the University Hospital Cologne, Department of Internal Medicine, Center for Integrated Oncology Aachen-Bonn-Cologne-Duesseldorf, Gastrointestinal Cancer Group Cologne, Cologne (T.Z.), and University Medical Center of Johannes Gutenberg-University Mainz (M.M.) - both in Germany; University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven (E.V.C.), and Ghent University Hospital, Ghent (K.G.) - both in Belgium; University Lille, Claude Huriez University Hospital, Lille (G.P.), and Pontchaillou University Hospital, Department of Gastroenterology, University of Rennes 1, INSERM Unité 1242, Rennes (A.L.) - both in France; Fundación Favaloro, Buenos Aires (G.M.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (J.F.); Akita University Hospital, Akita, Japan (S.M.); Duke Cancer Institute, Durham, NC (H.U.); Princess Margaret Cancer Centre, Toronto (E.E.), and Queen Elizabeth II Health Sciences Centre, Halifax, NS (S.S.) - both in Canada; the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam (C.G.); Florida Cancer Specialists and Research Institute, Fort Myers (S.Z.); University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco (A.H.K.); St. John of God Murdoch Hospital, Murdoch, WA, Australia (K.F.); Sfantul Nectarie Oncology Center, Craiova, Romania (M.S.); Bristol Myers Squibb, Princeton, NJ (J.Z., L.Z., M.L., P.S., K.K.); and Dana-Farber Cancer Institute, Boston (J.M.C.).'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'From the Charles A. Sammons Cancer Center at Baylor University Medical Center, Dallas (R.J.K.), and the University of Texas M.D. Anderson Cancer Center, Houston (J.A.A.); Jagiellonian University Medical College, John Paul II Hospital, Krakow, Poland (J.K., P.K.); the University Hospital Cologne, Department of Internal Medicine, Center for Integrated Oncology Aachen-Bonn-Cologne-Duesseldorf, Gastrointestinal Cancer Group Cologne, Cologne (T.Z.), and University Medical Center of Johannes Gutenberg-University Mainz (M.M.) - both in Germany; University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven (E.V.C.), and Ghent University Hospital, Ghent (K.G.) - both in Belgium; University Lille, Claude Huriez University Hospital, Lille (G.P.), and Pontchaillou University Hospital, Department of Gastroenterology, University of Rennes 1, INSERM Unité 1242, Rennes (A.L.) - both in France; Fundación Favaloro, Buenos Aires (G.M.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (J.F.); Akita University Hospital, Akita, Japan (S.M.); Duke Cancer Institute, Durham, NC (H.U.); Princess Margaret Cancer Centre, Toronto (E.E.), and Queen Elizabeth II Health Sciences Centre, Halifax, NS (S.S.) - both in Canada; the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam (C.G.); Florida Cancer Specialists and Research Institute, Fort Myers (S.Z.); University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco (A.H.K.); St. John of God Murdoch Hospital, Murdoch, WA, Australia (K.F.); Sfantul Nectarie Oncology Center, Craiova, Romania (M.S.); Bristol Myers Squibb, Princeton, NJ (J.Z., L.Z., M.L., P.S., K.K.); and Dana-Farber Cancer Institute, Boston (J.M.C.).'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Piessen', 'Affiliation': 'From the Charles A. Sammons Cancer Center at Baylor University Medical Center, Dallas (R.J.K.), and the University of Texas M.D. Anderson Cancer Center, Houston (J.A.A.); Jagiellonian University Medical College, John Paul II Hospital, Krakow, Poland (J.K., P.K.); the University Hospital Cologne, Department of Internal Medicine, Center for Integrated Oncology Aachen-Bonn-Cologne-Duesseldorf, Gastrointestinal Cancer Group Cologne, Cologne (T.Z.), and University Medical Center of Johannes Gutenberg-University Mainz (M.M.) - both in Germany; University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven (E.V.C.), and Ghent University Hospital, Ghent (K.G.) - both in Belgium; University Lille, Claude Huriez University Hospital, Lille (G.P.), and Pontchaillou University Hospital, Department of Gastroenterology, University of Rennes 1, INSERM Unité 1242, Rennes (A.L.) - both in France; Fundación Favaloro, Buenos Aires (G.M.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (J.F.); Akita University Hospital, Akita, Japan (S.M.); Duke Cancer Institute, Durham, NC (H.U.); Princess Margaret Cancer Centre, Toronto (E.E.), and Queen Elizabeth II Health Sciences Centre, Halifax, NS (S.S.) - both in Canada; the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam (C.G.); Florida Cancer Specialists and Research Institute, Fort Myers (S.Z.); University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco (A.H.K.); St. John of God Murdoch Hospital, Murdoch, WA, Australia (K.F.); Sfantul Nectarie Oncology Center, Craiova, Romania (M.S.); Bristol Myers Squibb, Princeton, NJ (J.Z., L.Z., M.L., P.S., K.K.); and Dana-Farber Cancer Institute, Boston (J.M.C.).'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Mendez', 'Affiliation': 'From the Charles A. Sammons Cancer Center at Baylor University Medical Center, Dallas (R.J.K.), and the University of Texas M.D. Anderson Cancer Center, Houston (J.A.A.); Jagiellonian University Medical College, John Paul II Hospital, Krakow, Poland (J.K., P.K.); the University Hospital Cologne, Department of Internal Medicine, Center for Integrated Oncology Aachen-Bonn-Cologne-Duesseldorf, Gastrointestinal Cancer Group Cologne, Cologne (T.Z.), and University Medical Center of Johannes Gutenberg-University Mainz (M.M.) - both in Germany; University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven (E.V.C.), and Ghent University Hospital, Ghent (K.G.) - both in Belgium; University Lille, Claude Huriez University Hospital, Lille (G.P.), and Pontchaillou University Hospital, Department of Gastroenterology, University of Rennes 1, INSERM Unité 1242, Rennes (A.L.) - both in France; Fundación Favaloro, Buenos Aires (G.M.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (J.F.); Akita University Hospital, Akita, Japan (S.M.); Duke Cancer Institute, Durham, NC (H.U.); Princess Margaret Cancer Centre, Toronto (E.E.), and Queen Elizabeth II Health Sciences Centre, Halifax, NS (S.S.) - both in Canada; the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam (C.G.); Florida Cancer Specialists and Research Institute, Fort Myers (S.Z.); University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco (A.H.K.); St. John of God Murdoch Hospital, Murdoch, WA, Australia (K.F.); Sfantul Nectarie Oncology Center, Craiova, Romania (M.S.); Bristol Myers Squibb, Princeton, NJ (J.Z., L.Z., M.L., P.S., K.K.); and Dana-Farber Cancer Institute, Boston (J.M.C.).'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Feliciano', 'Affiliation': 'From the Charles A. Sammons Cancer Center at Baylor University Medical Center, Dallas (R.J.K.), and the University of Texas M.D. Anderson Cancer Center, Houston (J.A.A.); Jagiellonian University Medical College, John Paul II Hospital, Krakow, Poland (J.K., P.K.); the University Hospital Cologne, Department of Internal Medicine, Center for Integrated Oncology Aachen-Bonn-Cologne-Duesseldorf, Gastrointestinal Cancer Group Cologne, Cologne (T.Z.), and University Medical Center of Johannes Gutenberg-University Mainz (M.M.) - both in Germany; University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven (E.V.C.), and Ghent University Hospital, Ghent (K.G.) - both in Belgium; University Lille, Claude Huriez University Hospital, Lille (G.P.), and Pontchaillou University Hospital, Department of Gastroenterology, University of Rennes 1, INSERM Unité 1242, Rennes (A.L.) - both in France; Fundación Favaloro, Buenos Aires (G.M.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (J.F.); Akita University Hospital, Akita, Japan (S.M.); Duke Cancer Institute, Durham, NC (H.U.); Princess Margaret Cancer Centre, Toronto (E.E.), and Queen Elizabeth II Health Sciences Centre, Halifax, NS (S.S.) - both in Canada; the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam (C.G.); Florida Cancer Specialists and Research Institute, Fort Myers (S.Z.); University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco (A.H.K.); St. John of God Murdoch Hospital, Murdoch, WA, Australia (K.F.); Sfantul Nectarie Oncology Center, Craiova, Romania (M.S.); Bristol Myers Squibb, Princeton, NJ (J.Z., L.Z., M.L., P.S., K.K.); and Dana-Farber Cancer Institute, Boston (J.M.C.).'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Motoyama', 'Affiliation': 'From the Charles A. Sammons Cancer Center at Baylor University Medical Center, Dallas (R.J.K.), and the University of Texas M.D. Anderson Cancer Center, Houston (J.A.A.); Jagiellonian University Medical College, John Paul II Hospital, Krakow, Poland (J.K., P.K.); the University Hospital Cologne, Department of Internal Medicine, Center for Integrated Oncology Aachen-Bonn-Cologne-Duesseldorf, Gastrointestinal Cancer Group Cologne, Cologne (T.Z.), and University Medical Center of Johannes Gutenberg-University Mainz (M.M.) - both in Germany; University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven (E.V.C.), and Ghent University Hospital, Ghent (K.G.) - both in Belgium; University Lille, Claude Huriez University Hospital, Lille (G.P.), and Pontchaillou University Hospital, Department of Gastroenterology, University of Rennes 1, INSERM Unité 1242, Rennes (A.L.) - both in France; Fundación Favaloro, Buenos Aires (G.M.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (J.F.); Akita University Hospital, Akita, Japan (S.M.); Duke Cancer Institute, Durham, NC (H.U.); Princess Margaret Cancer Centre, Toronto (E.E.), and Queen Elizabeth II Health Sciences Centre, Halifax, NS (S.S.) - both in Canada; the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam (C.G.); Florida Cancer Specialists and Research Institute, Fort Myers (S.Z.); University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco (A.H.K.); St. John of God Murdoch Hospital, Murdoch, WA, Australia (K.F.); Sfantul Nectarie Oncology Center, Craiova, Romania (M.S.); Bristol Myers Squibb, Princeton, NJ (J.Z., L.Z., M.L., P.S., K.K.); and Dana-Farber Cancer Institute, Boston (J.M.C.).'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Lièvre', 'Affiliation': 'From the Charles A. Sammons Cancer Center at Baylor University Medical Center, Dallas (R.J.K.), and the University of Texas M.D. Anderson Cancer Center, Houston (J.A.A.); Jagiellonian University Medical College, John Paul II Hospital, Krakow, Poland (J.K., P.K.); the University Hospital Cologne, Department of Internal Medicine, Center for Integrated Oncology Aachen-Bonn-Cologne-Duesseldorf, Gastrointestinal Cancer Group Cologne, Cologne (T.Z.), and University Medical Center of Johannes Gutenberg-University Mainz (M.M.) - both in Germany; University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven (E.V.C.), and Ghent University Hospital, Ghent (K.G.) - both in Belgium; University Lille, Claude Huriez University Hospital, Lille (G.P.), and Pontchaillou University Hospital, Department of Gastroenterology, University of Rennes 1, INSERM Unité 1242, Rennes (A.L.) - both in France; Fundación Favaloro, Buenos Aires (G.M.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (J.F.); Akita University Hospital, Akita, Japan (S.M.); Duke Cancer Institute, Durham, NC (H.U.); Princess Margaret Cancer Centre, Toronto (E.E.), and Queen Elizabeth II Health Sciences Centre, Halifax, NS (S.S.) - both in Canada; the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam (C.G.); Florida Cancer Specialists and Research Institute, Fort Myers (S.Z.); University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco (A.H.K.); St. John of God Murdoch Hospital, Murdoch, WA, Australia (K.F.); Sfantul Nectarie Oncology Center, Craiova, Romania (M.S.); Bristol Myers Squibb, Princeton, NJ (J.Z., L.Z., M.L., P.S., K.K.); and Dana-Farber Cancer Institute, Boston (J.M.C.).'}, {'ForeName': 'Hope', 'Initials': 'H', 'LastName': 'Uronis', 'Affiliation': 'From the Charles A. Sammons Cancer Center at Baylor University Medical Center, Dallas (R.J.K.), and the University of Texas M.D. Anderson Cancer Center, Houston (J.A.A.); Jagiellonian University Medical College, John Paul II Hospital, Krakow, Poland (J.K., P.K.); the University Hospital Cologne, Department of Internal Medicine, Center for Integrated Oncology Aachen-Bonn-Cologne-Duesseldorf, Gastrointestinal Cancer Group Cologne, Cologne (T.Z.), and University Medical Center of Johannes Gutenberg-University Mainz (M.M.) - both in Germany; University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven (E.V.C.), and Ghent University Hospital, Ghent (K.G.) - both in Belgium; University Lille, Claude Huriez University Hospital, Lille (G.P.), and Pontchaillou University Hospital, Department of Gastroenterology, University of Rennes 1, INSERM Unité 1242, Rennes (A.L.) - both in France; Fundación Favaloro, Buenos Aires (G.M.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (J.F.); Akita University Hospital, Akita, Japan (S.M.); Duke Cancer Institute, Durham, NC (H.U.); Princess Margaret Cancer Centre, Toronto (E.E.), and Queen Elizabeth II Health Sciences Centre, Halifax, NS (S.S.) - both in Canada; the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam (C.G.); Florida Cancer Specialists and Research Institute, Fort Myers (S.Z.); University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco (A.H.K.); St. John of God Murdoch Hospital, Murdoch, WA, Australia (K.F.); Sfantul Nectarie Oncology Center, Craiova, Romania (M.S.); Bristol Myers Squibb, Princeton, NJ (J.Z., L.Z., M.L., P.S., K.K.); and Dana-Farber Cancer Institute, Boston (J.M.C.).'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Elimova', 'Affiliation': 'From the Charles A. Sammons Cancer Center at Baylor University Medical Center, Dallas (R.J.K.), and the University of Texas M.D. Anderson Cancer Center, Houston (J.A.A.); Jagiellonian University Medical College, John Paul II Hospital, Krakow, Poland (J.K., P.K.); the University Hospital Cologne, Department of Internal Medicine, Center for Integrated Oncology Aachen-Bonn-Cologne-Duesseldorf, Gastrointestinal Cancer Group Cologne, Cologne (T.Z.), and University Medical Center of Johannes Gutenberg-University Mainz (M.M.) - both in Germany; University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven (E.V.C.), and Ghent University Hospital, Ghent (K.G.) - both in Belgium; University Lille, Claude Huriez University Hospital, Lille (G.P.), and Pontchaillou University Hospital, Department of Gastroenterology, University of Rennes 1, INSERM Unité 1242, Rennes (A.L.) - both in France; Fundación Favaloro, Buenos Aires (G.M.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (J.F.); Akita University Hospital, Akita, Japan (S.M.); Duke Cancer Institute, Durham, NC (H.U.); Princess Margaret Cancer Centre, Toronto (E.E.), and Queen Elizabeth II Health Sciences Centre, Halifax, NS (S.S.) - both in Canada; the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam (C.G.); Florida Cancer Specialists and Research Institute, Fort Myers (S.Z.); University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco (A.H.K.); St. John of God Murdoch Hospital, Murdoch, WA, Australia (K.F.); Sfantul Nectarie Oncology Center, Craiova, Romania (M.S.); Bristol Myers Squibb, Princeton, NJ (J.Z., L.Z., M.L., P.S., K.K.); and Dana-Farber Cancer Institute, Boston (J.M.C.).'}, {'ForeName': 'Cecile', 'Initials': 'C', 'LastName': 'Grootscholten', 'Affiliation': 'From the Charles A. Sammons Cancer Center at Baylor University Medical Center, Dallas (R.J.K.), and the University of Texas M.D. Anderson Cancer Center, Houston (J.A.A.); Jagiellonian University Medical College, John Paul II Hospital, Krakow, Poland (J.K., P.K.); the University Hospital Cologne, Department of Internal Medicine, Center for Integrated Oncology Aachen-Bonn-Cologne-Duesseldorf, Gastrointestinal Cancer Group Cologne, Cologne (T.Z.), and University Medical Center of Johannes Gutenberg-University Mainz (M.M.) - both in Germany; University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven (E.V.C.), and Ghent University Hospital, Ghent (K.G.) - both in Belgium; University Lille, Claude Huriez University Hospital, Lille (G.P.), and Pontchaillou University Hospital, Department of Gastroenterology, University of Rennes 1, INSERM Unité 1242, Rennes (A.L.) - both in France; Fundación Favaloro, Buenos Aires (G.M.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (J.F.); Akita University Hospital, Akita, Japan (S.M.); Duke Cancer Institute, Durham, NC (H.U.); Princess Margaret Cancer Centre, Toronto (E.E.), and Queen Elizabeth II Health Sciences Centre, Halifax, NS (S.S.) - both in Canada; the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam (C.G.); Florida Cancer Specialists and Research Institute, Fort Myers (S.Z.); University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco (A.H.K.); St. John of God Murdoch Hospital, Murdoch, WA, Australia (K.F.); Sfantul Nectarie Oncology Center, Craiova, Romania (M.S.); Bristol Myers Squibb, Princeton, NJ (J.Z., L.Z., M.L., P.S., K.K.); and Dana-Farber Cancer Institute, Boston (J.M.C.).'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Geboes', 'Affiliation': 'From the Charles A. Sammons Cancer Center at Baylor University Medical Center, Dallas (R.J.K.), and the University of Texas M.D. Anderson Cancer Center, Houston (J.A.A.); Jagiellonian University Medical College, John Paul II Hospital, Krakow, Poland (J.K., P.K.); the University Hospital Cologne, Department of Internal Medicine, Center for Integrated Oncology Aachen-Bonn-Cologne-Duesseldorf, Gastrointestinal Cancer Group Cologne, Cologne (T.Z.), and University Medical Center of Johannes Gutenberg-University Mainz (M.M.) - both in Germany; University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven (E.V.C.), and Ghent University Hospital, Ghent (K.G.) - both in Belgium; University Lille, Claude Huriez University Hospital, Lille (G.P.), and Pontchaillou University Hospital, Department of Gastroenterology, University of Rennes 1, INSERM Unité 1242, Rennes (A.L.) - both in France; Fundación Favaloro, Buenos Aires (G.M.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (J.F.); Akita University Hospital, Akita, Japan (S.M.); Duke Cancer Institute, Durham, NC (H.U.); Princess Margaret Cancer Centre, Toronto (E.E.), and Queen Elizabeth II Health Sciences Centre, Halifax, NS (S.S.) - both in Canada; the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam (C.G.); Florida Cancer Specialists and Research Institute, Fort Myers (S.Z.); University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco (A.H.K.); St. John of God Murdoch Hospital, Murdoch, WA, Australia (K.F.); Sfantul Nectarie Oncology Center, Craiova, Romania (M.S.); Bristol Myers Squibb, Princeton, NJ (J.Z., L.Z., M.L., P.S., K.K.); and Dana-Farber Cancer Institute, Boston (J.M.C.).'}, {'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Zafar', 'Affiliation': 'From the Charles A. Sammons Cancer Center at Baylor University Medical Center, Dallas (R.J.K.), and the University of Texas M.D. Anderson Cancer Center, Houston (J.A.A.); Jagiellonian University Medical College, John Paul II Hospital, Krakow, Poland (J.K., P.K.); the University Hospital Cologne, Department of Internal Medicine, Center for Integrated Oncology Aachen-Bonn-Cologne-Duesseldorf, Gastrointestinal Cancer Group Cologne, Cologne (T.Z.), and University Medical Center of Johannes Gutenberg-University Mainz (M.M.) - both in Germany; University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven (E.V.C.), and Ghent University Hospital, Ghent (K.G.) - both in Belgium; University Lille, Claude Huriez University Hospital, Lille (G.P.), and Pontchaillou University Hospital, Department of Gastroenterology, University of Rennes 1, INSERM Unité 1242, Rennes (A.L.) - both in France; Fundación Favaloro, Buenos Aires (G.M.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (J.F.); Akita University Hospital, Akita, Japan (S.M.); Duke Cancer Institute, Durham, NC (H.U.); Princess Margaret Cancer Centre, Toronto (E.E.), and Queen Elizabeth II Health Sciences Centre, Halifax, NS (S.S.) - both in Canada; the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam (C.G.); Florida Cancer Specialists and Research Institute, Fort Myers (S.Z.); University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco (A.H.K.); St. John of God Murdoch Hospital, Murdoch, WA, Australia (K.F.); Sfantul Nectarie Oncology Center, Craiova, Romania (M.S.); Bristol Myers Squibb, Princeton, NJ (J.Z., L.Z., M.L., P.S., K.K.); and Dana-Farber Cancer Institute, Boston (J.M.C.).'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Snow', 'Affiliation': 'From the Charles A. Sammons Cancer Center at Baylor University Medical Center, Dallas (R.J.K.), and the University of Texas M.D. Anderson Cancer Center, Houston (J.A.A.); Jagiellonian University Medical College, John Paul II Hospital, Krakow, Poland (J.K., P.K.); the University Hospital Cologne, Department of Internal Medicine, Center for Integrated Oncology Aachen-Bonn-Cologne-Duesseldorf, Gastrointestinal Cancer Group Cologne, Cologne (T.Z.), and University Medical Center of Johannes Gutenberg-University Mainz (M.M.) - both in Germany; University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven (E.V.C.), and Ghent University Hospital, Ghent (K.G.) - both in Belgium; University Lille, Claude Huriez University Hospital, Lille (G.P.), and Pontchaillou University Hospital, Department of Gastroenterology, University of Rennes 1, INSERM Unité 1242, Rennes (A.L.) - both in France; Fundación Favaloro, Buenos Aires (G.M.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (J.F.); Akita University Hospital, Akita, Japan (S.M.); Duke Cancer Institute, Durham, NC (H.U.); Princess Margaret Cancer Centre, Toronto (E.E.), and Queen Elizabeth II Health Sciences Centre, Halifax, NS (S.S.) - both in Canada; the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam (C.G.); Florida Cancer Specialists and Research Institute, Fort Myers (S.Z.); University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco (A.H.K.); St. John of God Murdoch Hospital, Murdoch, WA, Australia (K.F.); Sfantul Nectarie Oncology Center, Craiova, Romania (M.S.); Bristol Myers Squibb, Princeton, NJ (J.Z., L.Z., M.L., P.S., K.K.); and Dana-Farber Cancer Institute, Boston (J.M.C.).'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Ko', 'Affiliation': 'From the Charles A. Sammons Cancer Center at Baylor University Medical Center, Dallas (R.J.K.), and the University of Texas M.D. Anderson Cancer Center, Houston (J.A.A.); Jagiellonian University Medical College, John Paul II Hospital, Krakow, Poland (J.K., P.K.); the University Hospital Cologne, Department of Internal Medicine, Center for Integrated Oncology Aachen-Bonn-Cologne-Duesseldorf, Gastrointestinal Cancer Group Cologne, Cologne (T.Z.), and University Medical Center of Johannes Gutenberg-University Mainz (M.M.) - both in Germany; University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven (E.V.C.), and Ghent University Hospital, Ghent (K.G.) - both in Belgium; University Lille, Claude Huriez University Hospital, Lille (G.P.), and Pontchaillou University Hospital, Department of Gastroenterology, University of Rennes 1, INSERM Unité 1242, Rennes (A.L.) - both in France; Fundación Favaloro, Buenos Aires (G.M.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (J.F.); Akita University Hospital, Akita, Japan (S.M.); Duke Cancer Institute, Durham, NC (H.U.); Princess Margaret Cancer Centre, Toronto (E.E.), and Queen Elizabeth II Health Sciences Centre, Halifax, NS (S.S.) - both in Canada; the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam (C.G.); Florida Cancer Specialists and Research Institute, Fort Myers (S.Z.); University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco (A.H.K.); St. John of God Murdoch Hospital, Murdoch, WA, Australia (K.F.); Sfantul Nectarie Oncology Center, Craiova, Romania (M.S.); Bristol Myers Squibb, Princeton, NJ (J.Z., L.Z., M.L., P.S., K.K.); and Dana-Farber Cancer Institute, Boston (J.M.C.).'}, {'ForeName': 'Kynan', 'Initials': 'K', 'LastName': 'Feeney', 'Affiliation': 'From the Charles A. Sammons Cancer Center at Baylor University Medical Center, Dallas (R.J.K.), and the University of Texas M.D. Anderson Cancer Center, Houston (J.A.A.); Jagiellonian University Medical College, John Paul II Hospital, Krakow, Poland (J.K., P.K.); the University Hospital Cologne, Department of Internal Medicine, Center for Integrated Oncology Aachen-Bonn-Cologne-Duesseldorf, Gastrointestinal Cancer Group Cologne, Cologne (T.Z.), and University Medical Center of Johannes Gutenberg-University Mainz (M.M.) - both in Germany; University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven (E.V.C.), and Ghent University Hospital, Ghent (K.G.) - both in Belgium; University Lille, Claude Huriez University Hospital, Lille (G.P.), and Pontchaillou University Hospital, Department of Gastroenterology, University of Rennes 1, INSERM Unité 1242, Rennes (A.L.) - both in France; Fundación Favaloro, Buenos Aires (G.M.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (J.F.); Akita University Hospital, Akita, Japan (S.M.); Duke Cancer Institute, Durham, NC (H.U.); Princess Margaret Cancer Centre, Toronto (E.E.), and Queen Elizabeth II Health Sciences Centre, Halifax, NS (S.S.) - both in Canada; the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam (C.G.); Florida Cancer Specialists and Research Institute, Fort Myers (S.Z.); University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco (A.H.K.); St. John of God Murdoch Hospital, Murdoch, WA, Australia (K.F.); Sfantul Nectarie Oncology Center, Craiova, Romania (M.S.); Bristol Myers Squibb, Princeton, NJ (J.Z., L.Z., M.L., P.S., K.K.); and Dana-Farber Cancer Institute, Boston (J.M.C.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schenker', 'Affiliation': 'From the Charles A. Sammons Cancer Center at Baylor University Medical Center, Dallas (R.J.K.), and the University of Texas M.D. Anderson Cancer Center, Houston (J.A.A.); Jagiellonian University Medical College, John Paul II Hospital, Krakow, Poland (J.K., P.K.); the University Hospital Cologne, Department of Internal Medicine, Center for Integrated Oncology Aachen-Bonn-Cologne-Duesseldorf, Gastrointestinal Cancer Group Cologne, Cologne (T.Z.), and University Medical Center of Johannes Gutenberg-University Mainz (M.M.) - both in Germany; University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven (E.V.C.), and Ghent University Hospital, Ghent (K.G.) - both in Belgium; University Lille, Claude Huriez University Hospital, Lille (G.P.), and Pontchaillou University Hospital, Department of Gastroenterology, University of Rennes 1, INSERM Unité 1242, Rennes (A.L.) - both in France; Fundación Favaloro, Buenos Aires (G.M.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (J.F.); Akita University Hospital, Akita, Japan (S.M.); Duke Cancer Institute, Durham, NC (H.U.); Princess Margaret Cancer Centre, Toronto (E.E.), and Queen Elizabeth II Health Sciences Centre, Halifax, NS (S.S.) - both in Canada; the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam (C.G.); Florida Cancer Specialists and Research Institute, Fort Myers (S.Z.); University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco (A.H.K.); St. John of God Murdoch Hospital, Murdoch, WA, Australia (K.F.); Sfantul Nectarie Oncology Center, Craiova, Romania (M.S.); Bristol Myers Squibb, Princeton, NJ (J.Z., L.Z., M.L., P.S., K.K.); and Dana-Farber Cancer Institute, Boston (J.M.C.).'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Kocon', 'Affiliation': 'From the Charles A. Sammons Cancer Center at Baylor University Medical Center, Dallas (R.J.K.), and the University of Texas M.D. Anderson Cancer Center, Houston (J.A.A.); Jagiellonian University Medical College, John Paul II Hospital, Krakow, Poland (J.K., P.K.); the University Hospital Cologne, Department of Internal Medicine, Center for Integrated Oncology Aachen-Bonn-Cologne-Duesseldorf, Gastrointestinal Cancer Group Cologne, Cologne (T.Z.), and University Medical Center of Johannes Gutenberg-University Mainz (M.M.) - both in Germany; University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven (E.V.C.), and Ghent University Hospital, Ghent (K.G.) - both in Belgium; University Lille, Claude Huriez University Hospital, Lille (G.P.), and Pontchaillou University Hospital, Department of Gastroenterology, University of Rennes 1, INSERM Unité 1242, Rennes (A.L.) - both in France; Fundación Favaloro, Buenos Aires (G.M.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (J.F.); Akita University Hospital, Akita, Japan (S.M.); Duke Cancer Institute, Durham, NC (H.U.); Princess Margaret Cancer Centre, Toronto (E.E.), and Queen Elizabeth II Health Sciences Centre, Halifax, NS (S.S.) - both in Canada; the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam (C.G.); Florida Cancer Specialists and Research Institute, Fort Myers (S.Z.); University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco (A.H.K.); St. John of God Murdoch Hospital, Murdoch, WA, Australia (K.F.); Sfantul Nectarie Oncology Center, Craiova, Romania (M.S.); Bristol Myers Squibb, Princeton, NJ (J.Z., L.Z., M.L., P.S., K.K.); and Dana-Farber Cancer Institute, Boston (J.M.C.).'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'From the Charles A. Sammons Cancer Center at Baylor University Medical Center, Dallas (R.J.K.), and the University of Texas M.D. Anderson Cancer Center, Houston (J.A.A.); Jagiellonian University Medical College, John Paul II Hospital, Krakow, Poland (J.K., P.K.); the University Hospital Cologne, Department of Internal Medicine, Center for Integrated Oncology Aachen-Bonn-Cologne-Duesseldorf, Gastrointestinal Cancer Group Cologne, Cologne (T.Z.), and University Medical Center of Johannes Gutenberg-University Mainz (M.M.) - both in Germany; University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven (E.V.C.), and Ghent University Hospital, Ghent (K.G.) - both in Belgium; University Lille, Claude Huriez University Hospital, Lille (G.P.), and Pontchaillou University Hospital, Department of Gastroenterology, University of Rennes 1, INSERM Unité 1242, Rennes (A.L.) - both in France; Fundación Favaloro, Buenos Aires (G.M.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (J.F.); Akita University Hospital, Akita, Japan (S.M.); Duke Cancer Institute, Durham, NC (H.U.); Princess Margaret Cancer Centre, Toronto (E.E.), and Queen Elizabeth II Health Sciences Centre, Halifax, NS (S.S.) - both in Canada; the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam (C.G.); Florida Cancer Specialists and Research Institute, Fort Myers (S.Z.); University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco (A.H.K.); St. John of God Murdoch Hospital, Murdoch, WA, Australia (K.F.); Sfantul Nectarie Oncology Center, Craiova, Romania (M.S.); Bristol Myers Squibb, Princeton, NJ (J.Z., L.Z., M.L., P.S., K.K.); and Dana-Farber Cancer Institute, Boston (J.M.C.).'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'From the Charles A. Sammons Cancer Center at Baylor University Medical Center, Dallas (R.J.K.), and the University of Texas M.D. Anderson Cancer Center, Houston (J.A.A.); Jagiellonian University Medical College, John Paul II Hospital, Krakow, Poland (J.K., P.K.); the University Hospital Cologne, Department of Internal Medicine, Center for Integrated Oncology Aachen-Bonn-Cologne-Duesseldorf, Gastrointestinal Cancer Group Cologne, Cologne (T.Z.), and University Medical Center of Johannes Gutenberg-University Mainz (M.M.) - both in Germany; University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven (E.V.C.), and Ghent University Hospital, Ghent (K.G.) - both in Belgium; University Lille, Claude Huriez University Hospital, Lille (G.P.), and Pontchaillou University Hospital, Department of Gastroenterology, University of Rennes 1, INSERM Unité 1242, Rennes (A.L.) - both in France; Fundación Favaloro, Buenos Aires (G.M.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (J.F.); Akita University Hospital, Akita, Japan (S.M.); Duke Cancer Institute, Durham, NC (H.U.); Princess Margaret Cancer Centre, Toronto (E.E.), and Queen Elizabeth II Health Sciences Centre, Halifax, NS (S.S.) - both in Canada; the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam (C.G.); Florida Cancer Specialists and Research Institute, Fort Myers (S.Z.); University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco (A.H.K.); St. John of God Murdoch Hospital, Murdoch, WA, Australia (K.F.); Sfantul Nectarie Oncology Center, Craiova, Romania (M.S.); Bristol Myers Squibb, Princeton, NJ (J.Z., L.Z., M.L., P.S., K.K.); and Dana-Farber Cancer Institute, Boston (J.M.C.).'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Lei', 'Affiliation': 'From the Charles A. Sammons Cancer Center at Baylor University Medical Center, Dallas (R.J.K.), and the University of Texas M.D. Anderson Cancer Center, Houston (J.A.A.); Jagiellonian University Medical College, John Paul II Hospital, Krakow, Poland (J.K., P.K.); the University Hospital Cologne, Department of Internal Medicine, Center for Integrated Oncology Aachen-Bonn-Cologne-Duesseldorf, Gastrointestinal Cancer Group Cologne, Cologne (T.Z.), and University Medical Center of Johannes Gutenberg-University Mainz (M.M.) - both in Germany; University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven (E.V.C.), and Ghent University Hospital, Ghent (K.G.) - both in Belgium; University Lille, Claude Huriez University Hospital, Lille (G.P.), and Pontchaillou University Hospital, Department of Gastroenterology, University of Rennes 1, INSERM Unité 1242, Rennes (A.L.) - both in France; Fundación Favaloro, Buenos Aires (G.M.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (J.F.); Akita University Hospital, Akita, Japan (S.M.); Duke Cancer Institute, Durham, NC (H.U.); Princess Margaret Cancer Centre, Toronto (E.E.), and Queen Elizabeth II Health Sciences Centre, Halifax, NS (S.S.) - both in Canada; the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam (C.G.); Florida Cancer Specialists and Research Institute, Fort Myers (S.Z.); University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco (A.H.K.); St. John of God Murdoch Hospital, Murdoch, WA, Australia (K.F.); Sfantul Nectarie Oncology Center, Craiova, Romania (M.S.); Bristol Myers Squibb, Princeton, NJ (J.Z., L.Z., M.L., P.S., K.K.); and Dana-Farber Cancer Institute, Boston (J.M.C.).'}, {'ForeName': 'Prianka', 'Initials': 'P', 'LastName': 'Singh', 'Affiliation': 'From the Charles A. Sammons Cancer Center at Baylor University Medical Center, Dallas (R.J.K.), and the University of Texas M.D. Anderson Cancer Center, Houston (J.A.A.); Jagiellonian University Medical College, John Paul II Hospital, Krakow, Poland (J.K., P.K.); the University Hospital Cologne, Department of Internal Medicine, Center for Integrated Oncology Aachen-Bonn-Cologne-Duesseldorf, Gastrointestinal Cancer Group Cologne, Cologne (T.Z.), and University Medical Center of Johannes Gutenberg-University Mainz (M.M.) - both in Germany; University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven (E.V.C.), and Ghent University Hospital, Ghent (K.G.) - both in Belgium; University Lille, Claude Huriez University Hospital, Lille (G.P.), and Pontchaillou University Hospital, Department of Gastroenterology, University of Rennes 1, INSERM Unité 1242, Rennes (A.L.) - both in France; Fundación Favaloro, Buenos Aires (G.M.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (J.F.); Akita University Hospital, Akita, Japan (S.M.); Duke Cancer Institute, Durham, NC (H.U.); Princess Margaret Cancer Centre, Toronto (E.E.), and Queen Elizabeth II Health Sciences Centre, Halifax, NS (S.S.) - both in Canada; the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam (C.G.); Florida Cancer Specialists and Research Institute, Fort Myers (S.Z.); University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco (A.H.K.); St. John of God Murdoch Hospital, Murdoch, WA, Australia (K.F.); Sfantul Nectarie Oncology Center, Craiova, Romania (M.S.); Bristol Myers Squibb, Princeton, NJ (J.Z., L.Z., M.L., P.S., K.K.); and Dana-Farber Cancer Institute, Boston (J.M.C.).'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Kondo', 'Affiliation': 'From the Charles A. Sammons Cancer Center at Baylor University Medical Center, Dallas (R.J.K.), and the University of Texas M.D. Anderson Cancer Center, Houston (J.A.A.); Jagiellonian University Medical College, John Paul II Hospital, Krakow, Poland (J.K., P.K.); the University Hospital Cologne, Department of Internal Medicine, Center for Integrated Oncology Aachen-Bonn-Cologne-Duesseldorf, Gastrointestinal Cancer Group Cologne, Cologne (T.Z.), and University Medical Center of Johannes Gutenberg-University Mainz (M.M.) - both in Germany; University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven (E.V.C.), and Ghent University Hospital, Ghent (K.G.) - both in Belgium; University Lille, Claude Huriez University Hospital, Lille (G.P.), and Pontchaillou University Hospital, Department of Gastroenterology, University of Rennes 1, INSERM Unité 1242, Rennes (A.L.) - both in France; Fundación Favaloro, Buenos Aires (G.M.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (J.F.); Akita University Hospital, Akita, Japan (S.M.); Duke Cancer Institute, Durham, NC (H.U.); Princess Margaret Cancer Centre, Toronto (E.E.), and Queen Elizabeth II Health Sciences Centre, Halifax, NS (S.S.) - both in Canada; the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam (C.G.); Florida Cancer Specialists and Research Institute, Fort Myers (S.Z.); University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco (A.H.K.); St. John of God Murdoch Hospital, Murdoch, WA, Australia (K.F.); Sfantul Nectarie Oncology Center, Craiova, Romania (M.S.); Bristol Myers Squibb, Princeton, NJ (J.Z., L.Z., M.L., P.S., K.K.); and Dana-Farber Cancer Institute, Boston (J.M.C.).'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Cleary', 'Affiliation': 'From the Charles A. Sammons Cancer Center at Baylor University Medical Center, Dallas (R.J.K.), and the University of Texas M.D. Anderson Cancer Center, Houston (J.A.A.); Jagiellonian University Medical College, John Paul II Hospital, Krakow, Poland (J.K., P.K.); the University Hospital Cologne, Department of Internal Medicine, Center for Integrated Oncology Aachen-Bonn-Cologne-Duesseldorf, Gastrointestinal Cancer Group Cologne, Cologne (T.Z.), and University Medical Center of Johannes Gutenberg-University Mainz (M.M.) - both in Germany; University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven (E.V.C.), and Ghent University Hospital, Ghent (K.G.) - both in Belgium; University Lille, Claude Huriez University Hospital, Lille (G.P.), and Pontchaillou University Hospital, Department of Gastroenterology, University of Rennes 1, INSERM Unité 1242, Rennes (A.L.) - both in France; Fundación Favaloro, Buenos Aires (G.M.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (J.F.); Akita University Hospital, Akita, Japan (S.M.); Duke Cancer Institute, Durham, NC (H.U.); Princess Margaret Cancer Centre, Toronto (E.E.), and Queen Elizabeth II Health Sciences Centre, Halifax, NS (S.S.) - both in Canada; the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam (C.G.); Florida Cancer Specialists and Research Institute, Fort Myers (S.Z.); University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco (A.H.K.); St. John of God Murdoch Hospital, Murdoch, WA, Australia (K.F.); Sfantul Nectarie Oncology Center, Craiova, Romania (M.S.); Bristol Myers Squibb, Princeton, NJ (J.Z., L.Z., M.L., P.S., K.K.); and Dana-Farber Cancer Institute, Boston (J.M.C.).'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Moehler', 'Affiliation': 'From the Charles A. Sammons Cancer Center at Baylor University Medical Center, Dallas (R.J.K.), and the University of Texas M.D. Anderson Cancer Center, Houston (J.A.A.); Jagiellonian University Medical College, John Paul II Hospital, Krakow, Poland (J.K., P.K.); the University Hospital Cologne, Department of Internal Medicine, Center for Integrated Oncology Aachen-Bonn-Cologne-Duesseldorf, Gastrointestinal Cancer Group Cologne, Cologne (T.Z.), and University Medical Center of Johannes Gutenberg-University Mainz (M.M.) - both in Germany; University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven (E.V.C.), and Ghent University Hospital, Ghent (K.G.) - both in Belgium; University Lille, Claude Huriez University Hospital, Lille (G.P.), and Pontchaillou University Hospital, Department of Gastroenterology, University of Rennes 1, INSERM Unité 1242, Rennes (A.L.) - both in France; Fundación Favaloro, Buenos Aires (G.M.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (J.F.); Akita University Hospital, Akita, Japan (S.M.); Duke Cancer Institute, Durham, NC (H.U.); Princess Margaret Cancer Centre, Toronto (E.E.), and Queen Elizabeth II Health Sciences Centre, Halifax, NS (S.S.) - both in Canada; the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam (C.G.); Florida Cancer Specialists and Research Institute, Fort Myers (S.Z.); University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco (A.H.K.); St. John of God Murdoch Hospital, Murdoch, WA, Australia (K.F.); Sfantul Nectarie Oncology Center, Craiova, Romania (M.S.); Bristol Myers Squibb, Princeton, NJ (J.Z., L.Z., M.L., P.S., K.K.); and Dana-Farber Cancer Institute, Boston (J.M.C.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2032125'] 2796,33803836,"Effects of Tooth Brushing Training, Based on Augmented Reality Using a Smart Toothbrush, on Oral Hygiene Care among People with Intellectual Disability in Korea.","(1) Purpose: In modern society, augmented reality (AR)-based training using a smart device has emerged as a means of resolving problems with training. Thus, this feasibility study aimed to identify the effects of tooth-brushing training, based on AR using a smart toothbrush, on oral hygiene care among people with an intellectual disability in Korea. (2) Methods: Thirty people with an intellectual disability, residing in a residential care facility, were selected. Tooth-brushing training based on AR, using a smart toothbrush, was applied in the experimental group ( n = 15), and training using visual material was applied in the control group ( n = 15). As an assessment of oral hygiene care, the changes in tooth-brushing performance and oral hygiene were measured. (3) Results: There were significant differences in all results after training between the two groups. (4) Conclusions: Tooth-brushing training based on AR using a smart toothbrush is more effective than training using visual material on oral hygiene care among the subjects of this feasibility study. Thus, training based on AR using a smart toothbrush could be applied to people with intellectual disabilities residing in residential care facilities as an individual tool for tooth-brushing training.",2021,"Tooth-brushing training based on AR, using a smart toothbrush, was applied in the experimental group ( n = 15), and training using visual material was applied in the control group ( n = 15).","['Thirty people with an intellectual disability, residing in a residential care facility, were selected', 'people with intellectual disabilities residing in residential care facilities', 'people with an intellectual disability in Korea', 'People with Intellectual Disability in Korea']","['Tooth Brushing Training', 'tooth-brushing training']",['tooth-brushing performance and oral hygiene'],"[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0035186', 'cui_str': 'Residential Facilities'}, {'cui': 'C0022771', 'cui_str': 'Korea'}]","[{'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}]",30.0,0.00707711,"Tooth-brushing training based on AR, using a smart toothbrush, was applied in the experimental group ( n = 15), and training using visual material was applied in the control group ( n = 15).","[{'ForeName': 'Byoungjin', 'Initials': 'B', 'LastName': 'Jeon', 'Affiliation': 'Department of Occupational Therapy, Kangwon National University, Samcheok 25949, Korea.'}, {'ForeName': 'Jinseok', 'Initials': 'J', 'LastName': 'Oh', 'Affiliation': 'Department of Emergency Medical Rehabilitation Service, Graduate School of Kangwon National University, Samcheok 25949, Korea.'}, {'ForeName': 'Sungmin', 'Initials': 'S', 'LastName': 'Son', 'Affiliation': 'Department of Occupational Therapy, Jeonju Kijeon College, Jeonju 54989, Korea.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare9030348'] 2797,33793636,A randomized controlled trial of high volume simethicone to improve visualization during capsule endoscopy.,"BACKGROUND The optimal dose of simethicone before capsule endoscopy is unknown. Prior studies have reported inconsistent cleansing, with some showing improved visualization only in the proximal small intestine. We hypothesized a higher volume of simethicone may improve cleansing and diagnostic yield, especially in the distal small bowel. METHODS A phase III randomized controlled trial was conducted comparing high volume (1125 mg simethicone in 750 ml water) versus standard volume (300 mg simethicone in 200 ml water) solutions, both at 1.5 mg/ml. The primary outcome was adequate bowel preparation, defined as a KOrea-CanaDA (KODA) score >2.25, overall and stratified by the proximal and distal half of the small bowel. Secondary outcomes included mean KODA score, diagnostic yield, completion rate, and adverse events. All analyses were intention-to-treat. RESULTS A total of 167 patients were randomized (mean (SD) age 58.7 (15.7), 54% female) and the most common indication was obscure gastrointestinal bleeding (71.7%). Adequate cleansing was achieved in 39 (50%) patients in the high volume group and in 39 (48%) patients in the standard volume group (RR 1.04, 95% CI 0.76-1.43, p = 0.82), with no differences observed in the proximal half (71% vs 64%, p = 0.40) or the distal half -of the small bowel (36% vs. 37%, p = 0.88). There was no differences in the mean (SD) KODA score (2.20 (0.41) vs. 2.18 (0.44), p = 0.73), diagnostic yields (53% vs. 56%, p = 0.71), or completion rates (both 95%). One adverse event, nausea, occurred in the control group. CONCLUSION High volume simethicone does not improve visualization during capsule endoscopy. CLINICAL TRIAL REGISTRATION Clinical trial: NCT02334631.",2021,"One adverse event, nausea, occurred in the control group. ","['A total of 167 patients were randomized (mean (SD) age 58.7 (15.7), 54% female']",['high volume (1125 mg simethicone in 750 ml water) versus standard volume (300 mg simethicone'],"['mean KODA score, diagnostic yield, completion rate, and adverse events', 'completion rates', 'adequate bowel preparation, defined as a KOrea-CanaDA (KODA) score >2.25, overall and stratified by the proximal and distal half of the small bowel', 'adverse event, nausea', 'obscure gastrointestinal bleeding', 'Adequate cleansing', 'mean (SD) KODA score', 'diagnostic yields']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037138', 'cui_str': 'Simethicone'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C4068875', 'cui_str': '2.25'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C4302233', 'cui_str': 'Obscure gastrointestinal hemorrhage'}]",167.0,0.279024,"One adverse event, nausea, occurred in the control group. ","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sey', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Yan', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'McDonald', 'Affiliation': 'Lawson Health Research Institute, London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Segal', 'Affiliation': 'Niagara Health System, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Friedland', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Klajdi', 'Initials': 'K', 'LastName': 'Puka', 'Affiliation': 'Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada.'}, {'ForeName': 'Vipul', 'Initials': 'V', 'LastName': 'Jairath', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada.'}]",PloS one,['10.1371/journal.pone.0249490'] 2798,33793609,Balance rehabilitation with a virtual reality protocol for patients with hereditary spastic paraplegia: Protocol for a clinical trial.,"BACKGROUND Neurodegenerative diseases are sporadic hereditary conditions characterized by progressive dysfunction of the nervous system. Among the symptoms, vestibulopathy is one of the causes of discomfort and a decrease in quality of life. Hereditary spastic paraplegia is a heterogeneous group of hereditary degenerative diseases involving the disorder of a single gene and is characterized by the progressive retrograde degeneration of fibers in the spinal cord. OBJECTIVE To determine the benefits of vestibular rehabilitation involving virtual reality by comparing pre intervention and post intervention assessments in individuals with hereditary spastic paraplegia. METHODS In this randomized controlled clinical trial from the Rebec platform RBR-3jmx67 in which allocation concealment was performed and the evaluators be blinded will be included. The participants will include 40 patients diagnosed with hereditary spastic paraplegia. The interventions will include vestibular rehabilitation with virtual reality using the Wii® console, Wii-Remote and Wii Balance Board (Nintendo), and the studies will include pre- and post intervention assessments. Group I will include twenty volunteers who performed balance games. Group II will include twenty volunteers who performed balance games and muscle strength games. The games lasted from 30 minutes to an hour, and the sessions were performed twice a week for 10 weeks (total: 20 sessions). RESULTS This study provides a definitive assessment of the effectiveness of a virtual reality vestibular rehabilitation program in halting the progression of hereditary spastic paraplegia, and this treatment can be personalized and affordable. CONCLUSION The study will determine whether a vestibular rehabilitation program with the Nintendo Wii® involving virtual reality can reduce the progressive effect of hereditary spastic paraplegia and serve as an alternative treatment option that is accessible and inexpensive. Rebec platform trial: RBR-3JMX67.",2021,"This study provides a definitive assessment of the effectiveness of a virtual reality vestibular rehabilitation program in halting the progression of hereditary spastic paraplegia, and this treatment can be personalized and affordable. ","['twenty volunteers who performed balance games', '40 patients diagnosed with hereditary spastic paraplegia', 'patients with hereditary spastic paraplegia', 'individuals with hereditary spastic paraplegia']","['vestibular rehabilitation with virtual reality using the Wii® console, Wii-Remote and Wii Balance Board (Nintendo', 'RBR-3JMX67', 'vestibular rehabilitation involving virtual reality by comparing pre intervention', 'Balance rehabilitation with a virtual reality protocol', 'virtual reality vestibular rehabilitation program', 'balance games and muscle strength games']",['quality of life'],"[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0037773', 'cui_str': 'Hereditary spastic paraplegia'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C3873699', 'cui_str': 'Console'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C2721267', 'cui_str': 'Balance board'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",40.0,0.044274,"This study provides a definitive assessment of the effectiveness of a virtual reality vestibular rehabilitation program in halting the progression of hereditary spastic paraplegia, and this treatment can be personalized and affordable. ","[{'ForeName': 'Bianca Simone', 'Initials': 'BS', 'LastName': 'Zeigelboim', 'Affiliation': 'UTP- Universidade Tuiuti do Paraná, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Maria Renata', 'Initials': 'MR', 'LastName': 'José', 'Affiliation': 'UTP- Universidade Tuiuti do Paraná, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Geslaine Janaina Bueno Dos', 'Initials': 'GJBD', 'LastName': 'Santos', 'Affiliation': 'IFPR - Instituto Federal do Paraná, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Maria Izabel Rodrigues', 'Initials': 'MIR', 'LastName': 'Severiano', 'Affiliation': 'IFPR - Instituto Federal do Paraná, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Hélio Afonso Ghizoni', 'Initials': 'HAG', 'LastName': 'Teive', 'Affiliation': 'UFPR - Universidade Federal do Paraná, Curitiba, Paraná, Brazil.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Stechman-Neto', 'Affiliation': 'UTP- Universidade Tuiuti do Paraná, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Rosane Sampaio', 'Initials': 'RS', 'LastName': 'Santos', 'Affiliation': 'UTP- Universidade Tuiuti do Paraná, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Cristiano Miranda', 'Initials': 'CM', 'LastName': 'de Araújo', 'Affiliation': 'UTP- Universidade Tuiuti do Paraná, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Bianca Lopes', 'Initials': 'BL', 'LastName': 'Cavalcante-Leão', 'Affiliation': 'UTP- Universidade Tuiuti do Paraná, Curitiba, Paraná, Brazil.'}]",PloS one,['10.1371/journal.pone.0249095'] 2799,33790962,Motor Sequence Learning across Multiple Sessions Is Not Facilitated by Targeting Consolidation with Posttraining tDCS in Patients with Progressive Multiple Sclerosis.,"Compared to relapsing-remitting multiple sclerosis (MS), progressive MS is characterized by a lack of spontaneous recovery and a poor response to pharmaceutical immunomodulatory treatment. These patients may, therefore, particularly benefit from interventions that augment training-induced plasticity of the central nervous system. In this cross-sectional double-blind cross-over pilot study, effects of transcranial direct current stimulation (tDCS) on motor sequence learning were examined across four sessions on days 1, 3, 5, and 8 in 16 patients with progressive MS. Active or sham anodal tDCS of the primary motor cortex was applied immediately after each training session. Participants took part in two experiments separated by at least four weeks, which differed with respect to the type of posttraining tDCS (active or sham). While task performance across blocks of training and across sessions improved significantly in both the active and sham tDCS experiment, neither online nor offline motor learning was modulated by the type of tDCS. Accordingly, the primary endpoint (task performance on day 8) did not differ between stimulation conditions. In sum, patients with progressive MS are able to improve performance in an ecologically valid motor sequence learning task through training. However, even multisession posttraining tDCS fails to promote motor learning in progressive MS.",2021,"In sum, patients with progressive MS are able to improve performance in an ecologically valid motor sequence learning task through training.","['16 patients with progressive MS', 'Patients with Progressive Multiple Sclerosis']","['Active or sham anodal tDCS', 'transcranial direct current stimulation (tDCS']",['motor sequence learning'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",16.0,0.0480971,"In sum, patients with progressive MS are able to improve performance in an ecologically valid motor sequence learning task through training.","[{'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Seelmann-Eggebert', 'Affiliation': 'Department of Neurology, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Stoppe', 'Affiliation': 'Department of Neurology, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Then Bergh', 'Affiliation': 'Department of Neurology, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Classen', 'Affiliation': 'Department of Neurology, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Jost-Julian', 'Initials': 'JJ', 'LastName': 'Rumpf', 'Affiliation': 'Department of Neurology, University of Leipzig, Leipzig, Germany.'}]",Neural plasticity,['10.1155/2021/6696341'] 2800,33797785,Treatment responses in chronic temporomandibular patients depending on the treatment modalities and frequency of parafunctional behaviour.,"OBJECTIVES (i) To evaluate the effect of three different interventions on treatment outcomes and (ii) to determine how the frequency of oral parafunction influences the effectiveness of the different therapeutic modalities. METHODS Forty-five participants were randomly assigned into three treatment groups [physical therapy (PT), stabilisation splint (SS) and control therapy (CT)]. According to Oral Behavior Checklist score, participants were divided into ""high-frequency parafunction"" (HFP) and low-frequency parafunction"" (LFP) group. Primary (spontaneous pain and characteristic pain intensity) and secondary outcomes (range of mouth opening, anxiety symptoms, quality of life, perceived stress and global functional limitation) were evaluated during six-month treatment period. RESULTS Participants in PT group showed a significant reduction in characteristic pain intensity (p = .047, η 2  = 0.243) when compared to SS and CT group, but significant improvement in spontaneous pain was found in all treatment groups. Patients treated with PT and SS exhibited significantly stronger improvement in pain-free mouth opening than patients in CT group (3rd month: p=.037, η2=0.258; 6th month: p = .005, η 2  = 0.383). Within-group analyses showed significant decrease of perceived stress, anxiety symptoms and global functional limitation only in PT group over a six-month treatment period. Participants with HFP presented significantly greater levels of anxiety (3rd month: p = .009, η 2  = 0.275; 6th month: p = .041, η 2  = 0.176) than participants with LFP. Within-group analyses, however, showed significant improvement of anxiety, but also the decrease of perceived stress and improvement of global limitation for the HFP group but not for the LFP group. CONCLUSION Although no treatment can be marked as superior in terms of spontaneous pain relief, PT was more effective when observing relief of characteristic pain intensity. In HFP group the reduction of anxiety, stress and functional limitation was present regardless of the applied therapy. TRIAL REGISTRATION ClinicalTrials.gov NCT04694274. Registered on 01/04/2021.",2021,"Participants in PT group showed a significant reduction in characteristic pain intensity (p=0.047, η2=0.243) when compared to SS and CT group, but significant improvement in spontaneous pain was found in all treatment groups.","['chronic temporomandibular patients', 'Forty-five participants']","['physical therapy (PT), stabilization splint (SS) and control therapy (CT', 'PT and SS', 'HFP', 'high-frequency parafunction"" (HFP) and ""low-frequency parafunction"" (LFP']","['perceived stress and improvement of global limitation', 'anxiety', 'characteristic pain intensity', 'levels of anxiety', 'spontaneous pain', 'anxiety, stress and functional limitation', 'perceived stress, anxiety symptoms and global functional limitation', 'Primary (spontaneous pain and characteristic pain intensity) and secondary outcomes (range of mouth opening, anxiety symptoms, quality of life, perceived stress and global functional limitation', 'pain-free mouth opening']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319567', 'cui_str': '45'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C1997216', 'cui_str': 'Spontaneous pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}]",45.0,0.00734714,"Participants in PT group showed a significant reduction in characteristic pain intensity (p=0.047, η2=0.243) when compared to SS and CT group, but significant improvement in spontaneous pain was found in all treatment groups.","[{'ForeName': 'Marijana', 'Initials': 'M', 'LastName': 'Gikić', 'Affiliation': 'School of Dental Medicine, University of Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Ema', 'Initials': 'E', 'LastName': 'Vrbanović', 'Affiliation': 'Department of Removable Prosthodontics, School of Dental Medicine, University of Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Zlendić', 'Affiliation': 'School of Dental Medicine, University of Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Iva Z', 'Initials': 'IZ', 'LastName': 'Alajbeg', 'Affiliation': 'Department of Removable Prosthodontics, School of Dental Medicine, University of Zagreb, Zagreb, Croatia.'}]",Journal of oral rehabilitation,['10.1111/joor.13173'] 2801,33797485,LACTATE AS A MEDIATOR OF PREHOSPITAL PLASMA MORTALITY REDUCTION IN HEMORRHAGIC SHOCK.,"BACKGROUND Prehospital plasma transfusion in trauma reduces mortality. However, the underlying mechanism remains unclear. Reduction in shock severity may play a role. Lactate correlates with physiologic shock severity and mortality after injury. Our objective was to determine if prehospital plasma reduces lactate, and if this contributes to the mortality benefit of plasma. METHODS Patients in the Prehospital Air Medical Plasma trial in the upper quartile of injury severity (ISS>30) were included to capture severe shock. Trial patients were randomized to prehospital plasma or standard care resuscitation (crystalloid +/- PRBC). Regression determined the associations between admission lactate, 30-day mortality, and plasma while adjusting for demographics, prehospital crystalloid, time, mechanism, and injury characteristics. Causal mediation analysis determined what proportion of the effect of plasma on mortality is mediated by lactate reduction. RESULTS 125 patients were included. The plasma group had a lower adjusted admission lactate than standard of care group (coeff -1.64; 95%CI -2.96, -0.31, p=0.02). Plasma was associated with lower odds of 30-day mortality (OR 0.27; 95%CI 0.08-0.90, p=0.03). When adding lactate to this model, the effect of plasma on 30-day mortality was no longer significant (OR 0.36; 95%CI 0.07-1.88, p=0.23), while lactate was associated with mortality (OR 1.74 per 1mmol/L increase; 95%CI 1.10-2.73, p=0.01). Causal mediation demonstrated 35.1% of the total effect of plasma on 30-day mortality was mediated by the reduction in lactate among plasma patients. CONCLUSION Prehospital plasma is associated with reduced 30-day mortality and lactate in severely injured patients. Over one-third of the effect of plasma on mortality is mediated by a reduction in lactate. Thus, reducing the severity of hemorrhagic shock appears to be one mechanism of prehospital plasma benefit. Further study should elucidate other mechanisms and if a dose response exists. LEVEL OF EVIDENCE II, therapeutic.",2021,"Plasma was associated with lower odds of 30-day mortality (OR 0.27; 95%CI 0.08-0.90, p=0.03).","['125 patients were included', 'severely injured patients', 'Patients in the Prehospital Air Medical Plasma trial in the upper quartile of injury severity (ISS>30) were included to capture severe shock']",['prehospital plasma or standard care resuscitation (crystalloid '],"['mortality', 'adjusted admission lactate', '30-day mortality and lactate', '30-day mortality', 'admission lactate, 30-day mortality, and plasma while adjusting for demographics, prehospital crystalloid, time, mechanism, and injury characteristics']","[{'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0036974', 'cui_str': 'Shock'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]",125.0,0.102265,"Plasma was associated with lower odds of 30-day mortality (OR 0.27; 95%CI 0.08-0.90, p=0.03).","[{'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Canton', 'Affiliation': 'Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania Department of Surgery, University of Pennsylvania, Philadelphia, Pennsylvania Department of Surgery, University of Tennessee Health Science Center, Knoxville, Tennessee Department of Surgery, John Peter Smith Health Network, Fort Worth, Texas Department of Surgery, University of Louisville, Louisville, Kentucky Department of Surgery, MetroHealth Medical Center/Case Western Reserve University, Cleveland, Ohio Department of Surgery, Louisiana State University Health Sciences Center - New Orleans, New Orleans, LA Department of Emergency Medicine, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Waseem', 'Initials': 'W', 'LastName': 'Lutfi', 'Affiliation': ''}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Daley', 'Affiliation': ''}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Miller', 'Affiliation': ''}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Harbrecht', 'Affiliation': ''}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Claridge', 'Affiliation': ''}, {'ForeName': 'Herb A', 'Initials': 'HA', 'LastName': 'Phelan', 'Affiliation': ''}, {'ForeName': 'Francis X', 'Initials': 'FX', 'LastName': 'Guyette', 'Affiliation': ''}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Sperry', 'Affiliation': ''}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Brown', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000003173'] 2802,33797479,"A Comparison of Efficacy, Efficiency, and Durability in Novel Tourniquet Designs.","BACKGROUND Exsanguination due to extremity hemorrhage is a major cause of preventable traumatic deaths. Extremity tourniquet use has been shown to be safe and improve survival. The purpose of this study was to compare the efficacy, efficiency, and durability of the Generation 7 Combat Application Tourniquet (CAT), the Tactical Mechanical Tourniquet (TMT), and the SOF Tactical Tourniquet-Wide (SOFTT-W). METHODS This study was a three-phase randomized, cross over trial. In successive trials, subjects were timed during the application of each tourniquet to the upper and lower extremity. Following successful lower extremity application, subjects low crawled 25 feet and then were dragged 25 feet, after which effectiveness was reassessed, as defined by the cessation of distal pulses by doppler ultrasound. RESULTS In arm application, both the CAT and TMT had significantly less failure rates than the SOFTT-W (5.56%, 19.44%, 58.33%), with the CAT being the fastest tourniquet when compared to TMT and SOFTT-W (37.8 s, 65.01 s, 63.07s). In leg application, the CAT had significantly less rates of failure when compared to the SOFTT-W, but there was no other significant difference between the tourniquets (27.78%, 44.44%, 61.11%). In addition, the CAT was significantly faster than both the TMT and SOFTT-W when applied to the leg (8.33 s, 40.96 s, 34.5 s). There was no significant difference in tourniquet failure rates between the three tourniquets after subject maneuvers in phase three (34.29%, 42.86%, 45.45%). DISCUSSION The CAT is as effective as the TMT and significantly more effective than the SOFTT-W. In addition, the CAT demonstrated shorter application times than either the TMT or SOFTT-W. However, there was no significant difference between the three tourniquets in their ability to maintain pulselessness after subject maneuvers. LEVEL OF EVIDENCE Level II, Care Management.",2021,"There was no significant difference in tourniquet failure rates between the three tourniquets after subject maneuvers in phase three (34.29%, 42.86%, 45.45%). ",[],"['Generation 7 Combat Application Tourniquet (CAT), the Tactical Mechanical Tourniquet (TMT', 'CAT and TMT', 'CAT', 'TMT']","['Efficacy, Efficiency, and Durability', 'tourniquet failure rates', 'failure rates', 'rates of failure', 'efficacy, efficiency, and durability']",[],"[{'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",,0.0327275,"There was no significant difference in tourniquet failure rates between the three tourniquets after subject maneuvers in phase three (34.29%, 42.86%, 45.45%). ","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Treager', 'Affiliation': 'Department of Emergency Medicine, Naval Medical Readiness Training Command, Portsmouth, VA Combat Trauma Research Group, Naval Medical Readiness Training Command, General Dynamics Information Technology (GDIT), Fairfax, Virginia. Department of Emergency Medicine, Naval Medical Readiness Training Command, Guam Eastern Virginia Medical School, Norfolk, VA.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Lopachin', 'Affiliation': ''}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Mandichak', 'Affiliation': ''}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Kinney', 'Affiliation': ''}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Bohan', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Boboc', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Go', 'Affiliation': ''}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Friedrich', 'Affiliation': ''}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Stuart', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000003216'] 2803,33789145,Nanocurcumin improves Treg cell responses in patients with mild and severe SARS-CoV2.,"In Coronavirus disease 2019 (COVID-19), a decreased number of regulatory T (Treg) cells and their mediated factors lead to a hyperinflammatory state due to overactivation of the inflammatory cells and factors during the infection. In the current study, we evaluated the Nanocurcumin effects on the Treg cell population and corresponding factors in mild and severe COVID-19 patients. To investigate the Nanocurcumin effects, 80 COVID-19 patients (40 at the severe stage and 40 at the mild stage) were selected and classified into Nanocurcumin and placebo arms. In both the Nanocurcumin and placebo groups, the Treg cell frequency, the gene expression of Treg transcription factor forkhead box P3 (FoxP3), and cytokines (IL-10, IL-35, and TGF-β), as well as the serum levels of cytokines were measured before and after treatment. In both mild and severe COVID-19 patients, Nanocurcumin could considerably upregulate the frequency of Treg cells, the expression levels of FoxP3, IL-10, IL-35, and TGF-β, as well as the serum secretion levels of cytokines in the Nanocurcumin-treated group compared to the placebo group. The abovementioned factors were remarkably increased in the post-treatment with Nanocurcumin before pre-treatment conditions. By contrast, it has been observed no notable alteration in the placebo group. Our findings revealed the SinaCurcumin® effective function in a significant increase in the number of Treg cells and their mediated factors in the Nanocurcumin group than in the placebo group in both mild and severe patients. Hence, it would be an efficient therapeutic agent in rehabilitating COVID-19 infected patients.",2021,"In both the Nanocurcumin and placebo groups, the Treg cell frequency, the gene expression of Treg transcription factor forkhead box P3 (FoxP3), and cytokines (IL-10, IL-35, and TGF-β), as well as the serum levels of cytokines were measured before and after treatment.","['mild and severe COVID-19 patients', 'patients with mild and severe SARS-CoV2', '80 COVID-19 patients (40 at the severe stage and 40 at the mild stage']","['placebo', 'Nanocurcumin']","['frequency of Treg cells, the expression levels of FoxP3, IL-10, IL-35, and TGF-β', 'number of Treg cells', 'number of regulatory T (Treg) cells', 'serum levels of cytokines', 'Treg cell frequency, the gene expression of Treg transcription factor forkhead box P3 (FoxP3), and cytokines (IL-10, IL-35, and TGF-β', 'serum secretion levels of cytokines']","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0039198', 'cui_str': 'Regulatory T-Lymphocytes'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0040649', 'cui_str': 'Genetic transcription'}, {'cui': 'C0036536', 'cui_str': 'secretion'}]",,0.0826345,"In both the Nanocurcumin and placebo groups, the Treg cell frequency, the gene expression of Treg transcription factor forkhead box P3 (FoxP3), and cytokines (IL-10, IL-35, and TGF-β), as well as the serum levels of cytokines were measured before and after treatment.","[{'ForeName': 'Safa', 'Initials': 'S', 'LastName': 'Tahmasebi', 'Affiliation': 'Department of Immunology, Healthy Faculty, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Balsam Qubais', 'Initials': 'BQ', 'LastName': 'Saeed', 'Affiliation': 'Department of Clinical Sciences, College of Medicine, University of Sharjah, United Arab Emirates.'}, {'ForeName': 'Elmira', 'Initials': 'E', 'LastName': 'Temirgalieva', 'Affiliation': 'Department of Clinical Farmacology, National Medical University, Almaty, Kazakhstan.'}, {'ForeName': 'Alexei Valerievich', 'Initials': 'AV', 'LastName': 'Yumashev', 'Affiliation': 'Department of Prosthetic Dentistry, Sechenov First Moscow State Medical University, Moscow, Russia.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'El-Esawi', 'Affiliation': 'Botany Department, Faculty of Science, Tanta University, Tanta 31527, Egypt.'}, {'ForeName': 'Jamshid Gholizadeh', 'Initials': 'JG', 'LastName': 'Navashenaq', 'Affiliation': 'Noncommunicable Diseases Research Center, Bam University of Medical Sciences, Bam, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Valizadeh', 'Affiliation': 'Tuberculosis and Lung Disease Research Center of Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Sadeghi', 'Affiliation': 'Tuberculosis and Lung Disease Research Center of Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Aslani', 'Affiliation': 'Department of Immunology, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Yousefi', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Department of Immunology, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Jadidi-Niaragh', 'Affiliation': 'Department of Immunology, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Adigozalou', 'Affiliation': 'Department of Endodontics, Dental School, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Ahmadi', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: Ahmadi.m@tbzmed.ac.ir.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Roshangar', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: roshangarl@tbzmed.ac.ir.'}]",Life sciences,['10.1016/j.lfs.2021.119437'] 2804,33788837,Endotracheal intubation of COVID-19 patients by paramedics using a box barrier: A randomized crossover manikin study.,"BACKGROUND In the prehospital setting, endotracheal intubation (ETI) may be required to secure the coronavirus disease 2019 (COVID-19) patient airway. It has been suggested that the use of a protective barrier can reduce possible aerosol delivery from patients to clinicians during ETI. We sought to assess the performance of ETI by paramedics wearing personal protective equipment with and without the use of a box barrier. METHODS A randomized, crossover simulation study was performed in a simulation laboratory. Study participants were 18 paramedics actively working in the clinical environment. Participants' performance of ETI via direct laryngoscopy (DL) with and without the use of a box barrier was assessed. The sequence of intubation was randomized to either BoxDL-first or DL-first. The primary outcome was the success rate of ETI on first-attempt. The secondary and tertiary outcomes were ETI success rates on three attempts and total intubation time, respectively. RESULTS There were no differences between the DL group and the BoxDL group in one-attempt success rates (14/18 vs 12/18; P = 0.754), and in overall success rates (16/18 vs 14/18; P = 0.682). The mean (standard deviation) of the total intubation times for the DL group and the BoxDL group were 27.3 (19.7) seconds and 36.8 (26.2) seconds, respectively (P < 0.015). CONCLUSIONS The findings of this pilot study suggest that paramedics wearing personal protective equipment can successfully perform ETI using a barrier box, but the intubation time may be prolonged. The applicability of these findings to the care of COVID-19 patients remain to be investigated.",2021,"There were no differences between the DL group and the BoxDL group in one-attempt success rates (14/18 vs 12/18; P = 0.754), and in overall success rates (16/18 vs 14/18; P = 0.682).","['COVID-19 patients by paramedics using a box barrier', 'Study participants were 18 paramedics actively working in the clinical environment']",['endotracheal intubation (ETI'],"['overall success rates', 'ETI success rates on three attempts and total intubation time, respectively', 'total intubation times', 'performance of ETI via direct laryngoscopy (DL', 'success rates', 'success rate of ETI on first-attempt']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392823', 'cui_str': 'Direct laryngoscopy'}]",18.0,0.150033,"There were no differences between the DL group and the BoxDL group in one-attempt success rates (14/18 vs 12/18; P = 0.754), and in overall success rates (16/18 vs 14/18; P = 0.682).","[{'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Feldman', 'Affiliation': 'Pediatric Emergency Department, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Samuel', 'Affiliation': 'Pediatric Emergency Department, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Noa', 'Initials': 'N', 'LastName': 'Kvatinsky', 'Affiliation': 'Pediatric Emergency Department, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Ravit', 'Initials': 'R', 'LastName': 'Idelman', 'Affiliation': 'Pediatric Emergency Department, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Raz', 'Initials': 'R', 'LastName': 'Diamand', 'Affiliation': 'Pediatric Emergency Department, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Itai', 'Initials': 'I', 'LastName': 'Shavit', 'Affiliation': 'Pediatric Emergency Department, Rambam Health Care Campus, Haifa, Israel.'}]",PloS one,['10.1371/journal.pone.0248383'] 2805,33799119,Virtual Reality Warm-up Before Robot-assisted Surgery: A Randomized Controlled Trial.,"TRIAL DESIGN This was a randomized controlled trial. BACKGROUND Intraoperative errors correlate with surgeon skill and skill declines with intervals of inactivity. The goals of this research were to identify the optimal virtual reality (VR) warm-up curriculum to prime a surgeon's technical skill and validate benefit in the operating room. MATERIALS AND METHODS Surgeons were randomized to receive six trial sessions of a designated set of VR modules on the da Vinci Skills Simulator to identify optimal VR warm-up curricula to prime technical skill. After performing their curricula, warm-up effect was assessed based on performance on a criterion task. The optimal warm-up curriculum was chosen from the group with the best task time and video review-based technical skill. Robot-assisted surgery-experienced surgeons were then recruited to either receive or not receive warm-up before surgery. Skill in the first 15 min of surgery was assessed by blinded surgeon and crowdworker review as well as tool motion metrics. The intervention was performing VR warm-up before human robot-assisted surgery. Warm-up effect was measured using objective performance metrics and video review using the Global Evaluative Assessment of Robotic Skills tool. Linear mixed effects models with a random intercept for each surgeon and nonparametric modified Friedman tests were used for analysis. RESULTS The group performing only a Running Suture task on the simulator was on average 31.3 s faster than groups performing other simulation tasks and had the highest Global Evaluative Assessment of Robotic Skills scores from 41 surgeons who participated. This was chosen as the optimal curriculum. Thereafter, 34 surgeons completed 347 surgeries with corresponding video and tool motion data. No statistically significant differences in skill were observed with the warm-up intervention. CONCLUSIONS We conclude that a robotic VR warm-up before performing the early stages of surgery does not impact the technical skill of the surgeon.",2021,The group performing only a Running Suture task on the simulator was on average 31.3 s faster than groups performing other simulation tasks and had the highest Global Evaluative Assessment of Robotic Skills scores from 41 surgeons who participated.,"['34 surgeons completed 347 surgeries with corresponding video and tool motion data', '41 surgeons who participated', 'Surgeons']","['VR warm-up before human robot-assisted surgery', 'robotic VR', 'Robot-assisted surgery-experienced surgeons', 'Virtual Reality Warm-up Before Robot-assisted Surgery', 'Running Suture task on the simulator was on average 31.3\xa0s faster than groups performing other simulation tasks and had the highest Global Evaluative Assessment of Robotic Skills scores']",[],"[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0026597', 'cui_str': 'Motion'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",[],,0.124106,The group performing only a Running Suture task on the simulator was on average 31.3 s faster than groups performing other simulation tasks and had the highest Global Evaluative Assessment of Robotic Skills scores from 41 surgeons who participated.,"[{'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Kelly', 'Affiliation': 'University of Minnesota, Department of Mechanical Engineering, Minneapolis, Minnesota. Electronic address: kell1917@umn.edu.'}, {'ForeName': 'Timothy M', 'Initials': 'TM', 'LastName': 'Kowalewski', 'Affiliation': 'University of Minnesota, Department of Mechanical Engineering, Minneapolis, Minnesota.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Brand', 'Affiliation': 'University of Washington, Department of Urology, Seattle, Washington.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'French', 'Affiliation': 'University of Minnesota, Department of Mechanical Engineering, Minneapolis, Minnesota.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nash', 'Affiliation': 'University of Washington, Department of Urology, Seattle, Washington.'}, {'ForeName': 'Lois', 'Initials': 'L', 'LastName': 'Meryman', 'Affiliation': 'University of Washington, Department of Urology, Seattle, Washington.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Heller', 'Affiliation': 'University of Minnesota, Department of Mechanical Engineering, Minneapolis, Minnesota.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Organ', 'Affiliation': 'University of Washington, Department of Urology, Seattle, Washington.'}, {'ForeName': 'Evalyn', 'Initials': 'E', 'LastName': 'George', 'Affiliation': 'Madigan Army Medical Center, Henry M. Jackson Foundation, Tacoma, Washington.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Smith', 'Affiliation': 'Florida Hospital Nicholson Center, Orlando, Florida.'}, {'ForeName': 'Mathew D', 'Initials': 'MD', 'LastName': 'Sorensen', 'Affiliation': 'University of Washington, Department of Urology, Seattle, Washington.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Comstock', 'Affiliation': 'University of Washington, Department of Urology, Seattle, Washington.'}, {'ForeName': 'Thomas S', 'Initials': 'TS', 'LastName': 'Lendvay', 'Affiliation': 'University of Washington, Department of Urology, Seattle, Washington.'}]",The Journal of surgical research,['10.1016/j.jss.2021.01.037'] 2806,33799084,"The impact of a team-based learning group readiness assurance test on nursing students' problem solving, learning satisfaction, and team efficacy: A crossover study.","BACKGROUND Team-based learning in nursing education has shown higher rates of students that meet the learning outcomes in problem-solving. But students claim team-based learning has its drawbacks, and that the readiness assurance test takes too much time. Therefore, it is necessary to examine how the group readiness assurance test in team-based learning effects student's educational outcomes. OBJECTIVES This study was conducted to investigate the effects of the group readiness assurance tests on nursing students' problem solving, learning satisfaction, and team efficacy. DESIGN & METHOD This study used a crossover study design. The researchers conducted their study in team-based learning classes at a Korean university. The classes were conducted for eight weeks with nursing majors. In total, 194 students in their third year participated. Students received two different treatments: with and without a team test. The washout period was four weeks. RESULTS There was no statistically significant difference in nursing students' problem solving (t = 0.41, p = .679), learning satisfaction (t = 0.80, p = .420), or team efficacy (t = 1.20, p = .228) depending on the presence or absence of a team test. CONCLUSIONS When using team-based learning with nursing students, instructors should consider whether to conduct group readiness assurance tests are an efficient educational intervention and if they achieve the expected educational goals.",2021,"There was no statistically significant difference in nursing students' problem solving (t = 0.41, p = .679), learning satisfaction (t = 0.80, p = .420), or team efficacy (t = 1.20, p = .228) depending on the presence or absence of a team test. ",['194 students in their third year participated'],['team-based learning group readiness assurance test'],"['team efficacy', ""nursing students' problem solving"", 'learning satisfaction']","[{'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",194.0,0.0488887,"There was no statistically significant difference in nursing students' problem solving (t = 0.41, p = .679), learning satisfaction (t = 0.80, p = .420), or team efficacy (t = 1.20, p = .228) depending on the presence or absence of a team test. ","[{'ForeName': 'Mi Eun', 'Initials': 'ME', 'LastName': 'Kim', 'Affiliation': 'Jeonju University, 303 Cheonjam-ro, Wansan-gu, Jeonju-si 55069, Republic of Korea. Electronic address: mekim@jj.ac.kr.'}, {'ForeName': 'Jin Young', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Kyungmin University, 545, Seobu-ro, Uijeongbu-si, Gyeonggi-do, Republic of Korea.'}]",Nurse education today,['10.1016/j.nedt.2021.104819'] 2807,33799055,Mobile app-based chatbot to deliver cognitive behavioral therapy and psychoeducation for adults with attention deficit: A development and feasibility/usability study.,"BACKGROUND Attention deficit is a growing problem in adults, and early diagnosis and treatment are needed. Previous studies have shown that cognitive behavioral therapy (CBT) is effective in improving attention deficit symptoms. However, many patients are not receiving adequate treatment due to time, space, and cost constraints. Recently, in other mental illnesses, mobile-based chatbots delivering CBT and psychoeducation have been used for symptom mitigation and treatment. OBJECTIVE This study aimed to investigate the feasibility and usability of a short-term intervention, specifically a mobile-based interactive chatbot application, in alleviating attention deficit symptoms. METHODS This was a randomized, non-blind parallel-group pilot study conducted from September 2019 to March 2020. Forty-six individuals with attention deficit aged 19-60 were randomly allocated to the chatbot (n = 23) and information-only control groups (n = 23) for 4 weeks. The former group was instructed to use the chatbot application ""Todaki,"" while the latter group was provided with a book on managing attention deficit symptoms. Participants were administered questionnaires to assess their symptoms of attention deficit, depression, and anxiety and evaluated at baseline and 4 weeks after the intervention. The post-intervention survey assessed the chatbot's usability, acceptability, and side effects. RESULTS The average age of the participants was 25.1 years (standard deviation [SD] 7.5 years), and 56.5 % (26/46) participants were female. Intention-to-treat analysis (chatbot, n = 23; control, n = 23) revealed a significant reduction of attention deficit symptoms only in the chatbot group, which is represented by group-by-time interaction in Conner's Adult ADHD Rating Scale subscales of Diagnostic and Statistical Manual-IV Attention-Deficit/Hyperactivity Disorder (ADHD) Hyperactive-Impulsive symptoms (F = 4.39; p = .04) and ADHD symptoms total (F = 6.74, p = .01). Further, the results of the paired t-test were significant only in the chatbot group. The average number of times the chatbots were used in 4 weeks was 20.32 (SD 12.89). The total average usage time was 1 h 15 min (SD 1 h 20 min). The degree of improvement in the ADHD symptoms total score was correlated with the number of times the psychoeducation program was used. According to the participants, the empathic/friendly character and unnatural flow of conversation were the best and worst features of the chatbot, respectively. CONCLUSIONS This study identified the feasibility and usability of using the mobile-based chatbot to improve attention deficit and its associated psychiatric symptoms. Using this novel intervention to conduct CBT would provide a useful digital therapeutic tool that allows easy accessibility and self-guided management for people with attention deficit, which should be verified through the large scale randomized controlled trial.",2021,"This study aimed to investigate the feasibility and usability of a short-term intervention, specifically a mobile-based interactive chatbot application, in alleviating attention deficit symptoms. ","['adults with attention deficit', 'Forty-six individuals with attention deficit aged 19-60', 'The average age of the participants was 25.1 years (standard deviation [SD] 7.5 years), and 56.5 % (26/46) participants were female', 'September 2019 to March 2020']","['cognitive behavioral therapy (CBT', 'Mobile app-based chatbot to deliver cognitive behavioral therapy and psychoeducation']","['empathic/friendly character and unnatural flow of conversation', 'attention deficit symptoms', 'Hyperactive-Impulsive symptoms', 'total average usage time', 'symptoms of attention deficit, depression, and anxiety', 'ADHD Rating Scale subscales of Diagnostic and Statistical Manual-IV Attention-Deficit/Hyperactivity Disorder (ADHD', 'ADHD symptoms total', 'average number of times the chatbots', 'ADHD symptoms total score', ""chatbot's usability, acceptability, and side effects""]","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041671', 'cui_str': 'Attention Deficit Disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}]","[{'cui': 'C0007952', 'cui_str': 'Character'}, {'cui': 'C0522502', 'cui_str': 'Unnatural'}, {'cui': 'C0041671', 'cui_str': 'Attention Deficit Disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0449809', 'cui_str': 'Number of times'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",46.0,0.0278004,"This study aimed to investigate the feasibility and usability of a short-term intervention, specifically a mobile-based interactive chatbot application, in alleviating attention deficit symptoms. ","[{'ForeName': 'Sooah', 'Initials': 'S', 'LastName': 'Jang', 'Affiliation': 'Institute of Behavioral Sciences in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jae-Jin', 'Initials': 'JJ', 'LastName': 'Kim', 'Affiliation': 'Institute of Behavioral Sciences in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea; Department of Psychiatry, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Soo-Jeong', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Bundang Jesaeng Hospital, Seongnam-si, Republic of Korea.'}, {'ForeName': 'Jieun', 'Initials': 'J', 'LastName': 'Hong', 'Affiliation': 'Department of Psychiatry, National Health Insurance Service Ilsan Hospital, Goyang, Republic of Korea.'}, {'ForeName': 'Suji', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Institute of Behavioral Sciences in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Eunjoo', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'Institute of Behavioral Sciences in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea; Department of Psychiatry, Yonsei University College of Medicine, Seoul, Republic of Korea. Electronic address: EJKIM96@yuhs.ac.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2021.104440'] 2808,33799044,Cortisol effects on brain functional connectivity during emotion processing in women with depression.,"BACKGROUND Depression is associated with altered functional connectivity and altered cortisol sensitivity, but the effects of cortisol on functional connectivity in depression are unknown. Previous research shows that brief cortisol augmentation (CORT) has beneficial neurocognitive effects in depression. METHODS We investigated the effects of CORT (20mg oral cortisol) on functional connectivity during emotion processing in women with depression. Participants included 75 women with no depression or a depressive disorder. In a double-blind, crossover study, we used functional magnetic resonance imaging to measure effects of CORT vs. placebo on task-based functional connectivity during presentation of emotionally-laden images. We performed psychophysiological interaction (PPI) to test interactions among depression severity, cortisol administration, and task-dependent functional connectivity using the hippocampus and amygdala as seeds. RESULTS During the presentation of negative images, CORT (vs. placebo) increased functional connectivity between the hippocampus and putamen in association with depression severity. During the presentation of positive pictures CORT increased functional connectivity between the hippocampus and middle frontal gyrus as well as superior temporal gyrus in association with depression. LIMITATIONS Because cortisol was pharmacologically manipulated, results cannot be extrapolated to endogenous increases in cortisol levels. The sample did not permit investigation of differences due to race, ethnicity, or sex. Co-morbidities such as anxiety or PTSD were not accounted for. CONCLUSIONS The results suggest that CORT has normalizing effects on task-dependent functional connectivity in women with depression during emotion processing. Increasing cortisol availability or signaling may have therapeutic benefits within affective disorders.",2021,"During the presentation of positive pictures CORT increased functional connectivity between the hippocampus and middle frontal gyrus as well as superior temporal gyrus in association with depression. ","['women with depression during emotion processing', 'women with depression', 'Participants included 75 women with no depression or a depressive disorder']","['CORT', 'CORT vs. placebo', 'cortisol augmentation (CORT', 'CORT (20mg oral cortisol', 'CORT (vs. placebo']","['functional connectivity', 'functional connectivity during emotion processing', 'cortisol levels']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}]",75.0,0.126984,"During the presentation of positive pictures CORT increased functional connectivity between the hippocampus and middle frontal gyrus as well as superior temporal gyrus in association with depression. ","[{'ForeName': 'Charlene N', 'Initials': 'CN', 'LastName': 'Rivera-Bonet', 'Affiliation': 'Neuroscience Training Program, University of Wisconsin-Madison, Madison, WI, United States. Electronic address: riverabonet@wisc.edu.'}, {'ForeName': 'Rasmus M', 'Initials': 'RM', 'LastName': 'Birn', 'Affiliation': 'Neuroscience Training Program, University of Wisconsin-Madison, Madison, WI, United States; Department of Psychiatry, University of Wisconsin-Madison, Madison, WI, United States; Department of Medical Physics, University of Wisconsin-Madison, Madison, WI, United States.'}, {'ForeName': 'Charlotte O', 'Initials': 'CO', 'LastName': 'Ladd', 'Affiliation': 'Department of Psychiatry, University of Wisconsin-Madison, Madison, WI, United States.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Meyerand', 'Affiliation': 'Neuroscience Training Program, University of Wisconsin-Madison, Madison, WI, United States; Department of Medical Physics, University of Wisconsin-Madison, Madison, WI, United States; Department of Biomedical Engineering, University of Wisconsin-Madison, Madison, WI, United States.'}, {'ForeName': 'Heather C', 'Initials': 'HC', 'LastName': 'Abercrombie', 'Affiliation': 'Center for Healthy Minds, University of Wisconsin-Madison, Madison, WI, United States.'}]",Journal of affective disorders,['10.1016/j.jad.2021.03.034'] 2809,33798763,Exploring and optimizing the neuroplastic effects of anodal transcranial direct current stimulation over the primary motor cortex of older humans.,"BACKGROUND tDCS modulates cortical plasticity and has shown potential to improve cognitive/motor functions in healthy young humans. However, age-related alterations of brain structure and functions might require an adaptation of tDCS-parameters to achieve a targeted plasticity effect in older humans and conclusions obtained from young adults might not be directly transferable to older adults. Thus, our study aimed to systematically explore the association between tDCS-parameters and induced aftereffects on motor cortical excitability to determine optimal stimulation protocols for older individuals, as well as to investigate age-related differences of motor cortex plasticity in two different age groups of older adults. METHODS 32 healthy, volunteers from two different age groups of Young-Old (50-65 years, n = 16) and Old-Old (66-80 years, n = 16) participated in this study. Anodal tDCS was applied over the primary motor cortex, with respective combinations of three intensities (1, 2, and 3 mA) and durations (15, 20, and 30 min), in a sham-controlled cross-over design. Cortical excitability alterations were monitored by single-pulse TMS-induced MEPs until the next day morning after stimulation. RESULTS All active stimulation conditions resulted in a significant enhancement of motor cortical excitability in both age groups. The facilitatory aftereffects of anodal tDCS did not significantly differ between age groups. We observed prolonged plasticity in the late-phase range for two protocols with the highest stimulation intensity (i.e., 3 mA-20 min, 3 mA-30 min). CONCLUSIONS Our study highlights the role of stimulation dosage in tDCS-induced neuroplastic aftereffects in the motor cortex of healthy older adults and delivers crucial information about optimized tDCS protocols in the domain of the primary motor cortex. Our findings might set the grounds for the development of optimal stimulation protocols to reinstate neuroplasticity in different cortical areas and induce long-lasting, functionally relevant plasticity in normal aging and in pathological conditions, which would require however systematic tDCS titration studies over respective target areas.",2021,The facilitatory aftereffects of anodal tDCS did not significantly differ between age groups.,"['older humans', 'healthy young humans', '32 healthy, volunteers from two different age groups of Young-Old (50-65 years, n = 16) and Old-Old (66-80 years, n = 16) participated in this study', 'older individuals', 'healthy older adults']","['anodal transcranial direct current stimulation', 'Anodal tDCS']","['Cortical excitability alterations', 'motor cortical excitability', 'facilitatory aftereffects of anodal tDCS']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001795', 'cui_str': 'Oldest Old'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]",16.0,0.0343652,The facilitatory aftereffects of anodal tDCS did not significantly differ between age groups.,"[{'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Farnad', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund, Germany.'}, {'ForeName': 'Ensiyeh', 'Initials': 'E', 'LastName': 'Ghasemian-Shirvan', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund, Germany; International Graduate School of Neuroscience, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Mosayebi-Samani', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund, Germany.'}, {'ForeName': 'Min-Fang', 'Initials': 'MF', 'LastName': 'Kuo', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund, Germany.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nitsche', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund, Germany; Department of Neurology, University Hospital Bergmannsheil, Bochum, Germany. Electronic address: nitsche@ifado.de.'}]",Brain stimulation,['10.1016/j.brs.2021.03.013'] 2810,33798748,Fetal biometry in ultrasound: A new approach to assess the long-term impact of simulation on learning patterns.,"CONTEXT Simulation-based education (SBE) has demonstrated its acceptability and effectiveness in improving ultrasound training. Because of the high cost of its implementation (investment in equipment and supervision), a pragmatic assessment of the transfer of skills learned in SBE to clinical practice and the identification of its optimal scheduling conditions have been requested to optimize its input. OBJECTIVES To quantify the long-term impact of simulation-based education (SBE) on the adequate performance of ultrasound fetal biometry measurements (I). The secondary objective was to identify the temporal patterns that enhanced SBE input in learning (II). METHODS Trainees were arbitrarily assigned to a 6-month course in obstetric ultrasound with or without an SBE workshop. In the SBE group, the workshop was implemented 'before' or at an 'early' or a 'late-stage' of the course. Those who did not receive SBE were the control group. The ultrasound skills of all trainees were prospectively collected, evaluated by calculating the delta between OSAUS (Objective Structured Assessment of Ultrasound Skills) scores before and after the course (I). Concomitantly, the accuracy of trainees' measurements was assessed throughout the course by verifying their correlation with the corresponding measurements by their supervisors. The percentage of trainees able to perform five consecutive sets of correct measurements in the control group and in each SBE subgroup were compared (II). RESULTS The study included 61 trainees (39 SBE and 22 controls). Comparisons between groups showed no significant difference in the quantitative assessment of skill enhancement (difference in the pre- and post-internship OSAUS score: 1.09 ± 0.87 in the SBE group and 0.72 ± 0.98 in the control group) (I). Conversely, the predefined acceptable skill level was reached by a significantly higher proportion of trainees in the 'early' SBE subgroup (74%, compared with 30% in the control group, P<0.01)(II). CONCLUSIONS The quantitative assessment does not support the existence of long-term benefits from SBE training, although the qualitative assessment confirmed SBE helped to raise the minimal level within a group when embedded in an 'early' stage of a practical course.",2021,"Conversely, the predefined acceptable skill level was reached by a significantly higher proportion of trainees in the 'early' SBE subgroup (74%, compared with 30% in the control group, P<0.01)(II). ","['61 trainees (39 SBE and 22 controls', 'Trainees']","['SBE', 'simulation-based education (SBE', 'obstetric ultrasound with or without an SBE workshop']","['acceptability and effectiveness', 'quantitative assessment of skill enhancement', 'delta between OSAUS (Objective Structured Assessment of Ultrasound Skills) scores', 'enhanced SBE input in learning (II']","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0412555', 'cui_str': 'Ultrasound scan - obstetric'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",61.0,0.034315,"Conversely, the predefined acceptable skill level was reached by a significantly higher proportion of trainees in the 'early' SBE subgroup (74%, compared with 30% in the control group, P<0.01)(II). ","[{'ForeName': 'G Ambroise', 'Initials': 'GA', 'LastName': 'Grandjean', 'Affiliation': 'Université de Lorraine, IADI - INSERM, F-54000 Nancy, France; Department of Obstetrics and Gynecology, CHRU Nancy, F-54000 Nancy, France; Midwifery Department, Université de Lorraine, Nancy F-54000, France. Electronic address: g.ambroise@chru-nancy.fr.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bertholdt', 'Affiliation': 'Université de Lorraine, IADI - INSERM, F-54000 Nancy, France; Department of Obstetrics and Gynecology, CHRU Nancy, F-54000 Nancy, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Zuily', 'Affiliation': 'Université de Lorraine, Hôpital virtuel de Lorraine, Nancy F-54000, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fauvel', 'Affiliation': 'CHRU Nancy, Université de Lorraine, CIC-IT, F-54000 Nancy, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Hossu', 'Affiliation': 'CHRU Nancy, Université de Lorraine, CIC-IT, F-54000 Nancy, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Berveiller', 'Affiliation': 'Department of Obstetrics and Gynecology, CHI Poissy Saint-Germain-en-Laye, F-78300 Poissy, France; Université Versailles Saint-Quentin, EA 7404 - GIG, F-78180 Montigny le Bretonneux, France.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Morel', 'Affiliation': 'Université de Lorraine, IADI - INSERM, F-54000 Nancy, France; Department of Obstetrics and Gynecology, CHRU Nancy, F-54000 Nancy, France.'}]",Journal of gynecology obstetrics and human reproduction,['10.1016/j.jogoh.2021.102135'] 2811,33798730,Communication Coaching in Cardiology (CCC): A study protocol and methodological challenges and solutions of a randomized controlled trial in outpatient cardiology clinics.,"Given the role of effective communication in improving patient adherence and satisfaction, high quality patient-clinician communication is critical. Building on previous communication interventions in oncology and pediatrics, we developed a tailored communication coaching intervention to improve empathic communication quality and patient-centered care. In this randomized controlled trial, cardiologists record their patient encounters for review by a communication coach who provides tailored feedback. We are recruiting 40 cardiologists and 400 patients, or 4 patients per cardiologist in the Pre-intervention phase and 6 patients per cardiologists in the Post-intervention phase, from outpatient cardiology clinics within the Duke Health System. The primary goal of the trial is to determine the efficacy of the clinician communication coaching versus usual care in the post-intervention phase (240 patient encounters). In this paper, we describe the development of the communication coaching intervention. We also describe the details of the methods and outcomes of the ongoing trial. Finally, we discuss the challenges, solutions, and lessons learned during the start-up phase of the study.",2021,The primary goal of the trial is to determine the efficacy of the clinician communication coaching versus usual care in the post-intervention phase (240 patient encounters).,"['outpatient cardiology clinics', '40 cardiologists and 400 patients, or 4 patients per cardiologist in the Pre-intervention phase and 6 patients per cardiologists in the Post-intervention phase, from outpatient cardiology clinics within the Duke Health System', 'Cardiology (CCC']","['communication coaching intervention', 'clinician communication coaching']",[],"[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C3810847', 'cui_str': 'Cardiology clinic'}, {'cui': 'C0175906', 'cui_str': 'Cardiologist'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1512090', 'cui_str': 'Dukes staging system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0458993,The primary goal of the trial is to determine the efficacy of the clinician communication coaching versus usual care in the post-intervention phase (240 patient encounters).,"[{'ForeName': 'Danielle L', 'Initials': 'DL', 'LastName': 'Kennedy', 'Affiliation': 'Cancer Prevention and Control, Duke Cancer Institute, Durham, NC 27710, United States of America. Electronic address: Danielle.kennedy490@duke.edu.'}, {'ForeName': 'Maren K', 'Initials': 'MK', 'LastName': 'Olsen', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC 27710, United States of America; Durham Center of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Health Care System, Durham, NC 27705, United States of America.'}, {'ForeName': 'Hongqiu', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Duke Cancer Research Institute, Durham, NC 27710, United States of America.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Cancer Prevention and Control, Duke Cancer Institute, Durham, NC 27710, United States of America.'}, {'ForeName': 'Aviel', 'Initials': 'A', 'LastName': 'Alkon', 'Affiliation': 'Department of General Internal Medicine, Duke University School of Medicine, Durham, NC 27710, United States of America.'}, {'ForeName': 'Neil S', 'Initials': 'NS', 'LastName': 'Prose', 'Affiliation': 'Department of Dermatology and Pediatrics, Duke University School of Medicine, Durham, NC 27710, United States of America.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'Dunbar', 'Affiliation': 'Department of Population Health Sciences, Duke University School of Medicine, Durham, NC 27710, United States of America.'}, {'ForeName': 'Larry R', 'Initials': 'LR', 'LastName': 'Jackson', 'Affiliation': 'Department of Cardiology, Duke University School of Medicine, Durham, NC 27710, United States of America.'}, {'ForeName': 'Kathryn I', 'Initials': 'KI', 'LastName': 'Pollak', 'Affiliation': 'Cancer Prevention and Control, Duke Cancer Institute, Durham, NC 27710, United States of America; Department of Population Health Sciences, Duke University School of Medicine, Durham, NC 27710, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106389'] 2812,33803281,Clinical and Microbiological Evaluation of Local Doxycycline and Antimicrobial Photodynamic Therapy during Supportive Periodontal Therapy: A Randomized Clinical Trial.,"The aim of this study was to evaluate the clinical and microbiological effects of subgingival instrumentation (SI) alone or combined with either local drug delivery (LDD) or photodynamic therapy (PDT) in persistent/recurrent pockets in patients enrolled in supportive periodontal therapy (SPT). A total of 105 patients enrolled in SPT were randomly treated as follows: group A ( n = 35): SI +PDT and 7 days later 2nd PDT; group B ( n = 35): SI+LDD; group C ( n = 35): SI (control). Prior intervention, at 3 and 6 months after therapy, probing pocket depths, clinical attachment level, number of treated sites with bleeding on probing (n BOP), full mouth plaque and bleeding scores (gingival bleeding index, %BOP) were recorded. At the same time points, 8 periodontopathogens were quantitatively determined. All three treatments resulted in statistically significant improvements ( p < 0.05) of all clinical parameters without statistically significant intergroup differences ( p > 0.05). Several bacterial species were reduced in both test groups, with statistically significantly higher reductions for LDD compared to PDT and the control group. In conclusion, the present data indicate that: (a) In periodontal patients enrolled in SPT, treatment of persistent/recurrent pockets with SI alone or combined with either PDT or LDD may lead to comparable clinical improvements and (b) the adjunctive use of LDD appears to provide better microbiological improvements for some periodontal pathogens than SI alone or combined with PDT.",2021,All three treatments resulted in statistically significant improvements ( p < 0.05) of all clinical parameters without statistically significant intergroup differences ( p > 0.05).,"['patients enrolled in supportive periodontal therapy (SPT', '105 patients enrolled in SPT']","['Local Doxycycline and Antimicrobial Photodynamic Therapy', 'SI alone or combined with PDT', 'SI +PDT', 'PDT or LDD', 'subgingival instrumentation (SI) alone or combined with either local drug delivery (LDD) or photodynamic therapy (PDT']","['probing pocket depths, clinical attachment level, number of treated sites with bleeding on probing (n BOP), full mouth plaque and bleeding scores (gingival bleeding index, %BOP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4319547', 'cui_str': '105'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0595817', 'cui_str': 'Subgingival route'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C0221732', 'cui_str': 'Mouth plaque'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0580084', 'cui_str': 'Gingival bleeding index'}]",105.0,0.0758977,All three treatments resulted in statistically significant improvements ( p < 0.05) of all clinical parameters without statistically significant intergroup differences ( p > 0.05).,"[{'ForeName': 'Raluca', 'Initials': 'R', 'LastName': 'Cosgarea', 'Affiliation': 'Department for Periodontology, Operative and Preventive Dentistry, University of Bonn, 53111 Bonn, Germany.'}, {'ForeName': 'Sigrun', 'Initials': 'S', 'LastName': 'Eick', 'Affiliation': 'Department of Periodontology, School of Dentistry, University of Bern, 3010 Bern, Switzerland.'}, {'ForeName': 'Ionela', 'Initials': 'I', 'LastName': 'Batori-Andronescu', 'Affiliation': 'Department, Periodontal Private Practice Cosmedica, 400185 Cluj-Napoca, Romania.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Jepsen', 'Affiliation': 'Department for Periodontology, Operative and Preventive Dentistry, University of Bonn, 53111 Bonn, Germany.'}, {'ForeName': 'Nicole B', 'Initials': 'NB', 'LastName': 'Arweiler', 'Affiliation': 'Clinic for Periodontology and Peri-Implant Diseases, Philipps University Marburg, 35033 Marburg, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Rößler', 'Affiliation': 'University of Digital Technologies in Medicine & Dentistry, 9516 Wiltz, Luxembourg.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Conrad', 'Affiliation': 'University of Digital Technologies in Medicine & Dentistry, 9516 Wiltz, Luxembourg.'}, {'ForeName': 'Christoph A', 'Initials': 'CA', 'LastName': 'Ramseier', 'Affiliation': 'Department of Periodontology, School of Dentistry, University of Bern, 3010 Bern, Switzerland.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Sculean', 'Affiliation': 'Department of Periodontology, School of Dentistry, University of Bern, 3010 Bern, Switzerland.'}]","Antibiotics (Basel, Switzerland)",['10.3390/antibiotics10030277'] 2813,33802709,Adherence to Ketogenic and Mediterranean Study Diets in a Crossover Trial: The Keto-Med Randomized Trial.,"Adherence is a critical factor to consider when interpreting study results from randomized clinical trials (RCTs) comparing one diet to another, but it is frequently not reported by researchers. The purpose of this secondary analysis of the Keto-Med randomized trial was to provide a detailed examination and comparison of the adherence to the two study diets (Well Formulated Ketogenic Diet (WFKD) and Mediterranean Plus (Med-Plus)) under the two conditions: all food being provided (delivered) and all food being obtained by individual participants (self-provided). Diet was assessed at six time points including baseline (×1), week 4 of each phase when participants were receiving food deliveries (×2), week 12 of each phase when participants were preparing and providing food on their own (×2), and 12 weeks after participants completed both diet phases and were free to choose their own diet pattern (×1). The adherence scores for WFKD and Med-Plus were developed specifically for this study. Average adherence to the two diet patterns was very similar during both on-study time points of the intervention. Throughout the study, a wide range of adherence was observed among participants-for both diet types and during both the delivery phase and self-provided phase. Insight from this assessment of adherence may aid other researchers when answering the important question of how to improve behavioral adherence during dietary trials. This study is registered at clinicaltrials.gov NCT03810378.",2021,"Throughout the study, a wide range of adherence was observed among participants-for both diet types and during both the delivery phase and self-provided phase.",[],"['diets (Well Formulated Ketogenic Diet (WFKD) and Mediterranean Plus (Med-Plus', 'Ketogenic and Mediterranean Study Diets']","['Average adherence', 'behavioral adherence', 'adherence scores']",[],"[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.122836,"Throughout the study, a wide range of adherence was observed among participants-for both diet types and during both the delivery phase and self-provided phase.","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Landry', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, School of Medicine, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Crimarco', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, School of Medicine, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'Perelman', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, School of Medicine, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Lindsay R', 'Initials': 'LR', 'LastName': 'Durand', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, School of Medicine, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Petlura', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, School of Medicine, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Aronica', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, School of Medicine, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Robinson', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, School of Medicine, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Sun H', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology, Gerontology and Metabolism, Department of Medicine, Stanford University Medical Center, Stanford, CA 94305, USA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Gardner', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, School of Medicine, Stanford University, Stanford, CA 94305, USA.'}]",Nutrients,['10.3390/nu13030967'] 2814,33802651,Comparison of Ketogenic Diets with and without Ketone Salts versus a Low-Fat Diet: Liver Fat Responses in Overweight Adults.,"Ketogenic diets (KDs) often contain high levels of saturated fat, which may increase liver fat, but the lower carbohydrate intake may have the opposite effect. Using a controlled feeding design, we compared liver fat responses to a hypocaloric KD with a placebo (PL) versus an energy-matched low-fat diet (LFD) in overweight adults. We also examined the added effect of a ketone supplement (KS). Overweight adults were randomized to a 6-week KD (KD + PL) or a KD with KS (KD + KS); an LFD group was recruited separately. All diets were estimated to provide 75% of energy expenditure. Weight loss was similar between groups ( p > 0.05). Liver fat assessed by magnetic resonance imaging decreased after 6 week ( p = 0.004) with no group differences ( p > 0.05). A subset with nonalcoholic fatty liver disease (NAFLD) (liver fat > 5%, n = 12) showed a greater reduction in liver fat, but no group differences. In KD participants with NAFLD, 92% of the variability in change in liver fat was explained by baseline liver fat ( p < 0.001). A short-term hypocaloric KD high in saturated fat does not adversely impact liver health and is not impacted by exogenous ketones. Hypocaloric low-fat and KDs can both be used in the short-term to significantly reduce liver fat in individuals with NAFLD.",2021,Liver fat assessed by magnetic resonance imaging decreased after 6 week ( p = 0.004) with no group differences ( p > 0.05).,"['overweight adults', 'individuals with NAFLD', 'A subset with nonalcoholic fatty liver disease (NAFLD) (liver fat', 'Overweight adults', 'Overweight Adults']","['ketone supplement (KS', 'Ketogenic Diets with and without Ketone Salts versus a Low-Fat Diet', '6-week KD (KD + PL) or a KD with KS (KD + KS', 'Hypocaloric low-fat and KDs', 'hypocaloric KD with a placebo (PL) versus an energy-matched low-fat diet (LFD', 'Ketogenic diets (KDs']","['Liver fat assessed by magnetic resonance imaging', 'Weight loss', 'liver fat']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]","[{'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.0192974,Liver fat assessed by magnetic resonance imaging decreased after 6 week ( p = 0.004) with no group differences ( p > 0.05).,"[{'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Crabtree', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43201, USA.'}, {'ForeName': 'Madison L', 'Initials': 'ML', 'LastName': 'Kackley', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43201, USA.'}, {'ForeName': 'Alexandru', 'Initials': 'A', 'LastName': 'Buga', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43201, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Fell', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43201, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'LaFountain', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43201, USA.'}, {'ForeName': 'Parker N', 'Initials': 'PN', 'LastName': 'Hyde', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43201, USA.'}, {'ForeName': 'Teryn N', 'Initials': 'TN', 'LastName': 'Sapper', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43201, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Kraemer', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43201, USA.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Scandling', 'Affiliation': 'Dorothy M. Davis Heart & Lung Research Institute, The Ohio State University, Columbus, OH 43210, USA.'}, {'ForeName': 'Orlando P', 'Initials': 'OP', 'LastName': 'Simonetti', 'Affiliation': 'Dorothy M. Davis Heart & Lung Research Institute, The Ohio State University, Columbus, OH 43210, USA.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Volek', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43201, USA.'}]",Nutrients,['10.3390/nu13030966'] 2815,33802497,"Adjuvant Transgingival Therapy with Visible Light Plus Water-Filtered Infrared-A (VIS + wIRA) in Periodontal Therapy-A Randomized, Controlled, Stratified, Double-Blinded Clinical Trial.","The aim of this randomized, controlled, double-blinded clinical trial was to examine the additional healing effect of transgingival visible light and water-filtered infrared-A (VIS + wIRA) in the treatment of periodontitis patients compared with the standard therapy by subgingival instrumentation (SI). Therefore, forty patients with untreated periodontitis received a non-surgical periodontal treatment. Using a split-mouth study design, one quadrant of the upper jaw was randomly either exposed to VIS + wIRA four times for 20 min within two weeks in addition to SI or received only SI. Three and 6 months after intervention, clinical parameters (probing depths (PDs), clinical attachment level, bleeding on probing (BOP), furcation, tooth mobility, plaque control record, and papilla bleeding index) were re-evaluated. In the presence of PD of 4 mm and positive BOP or PD > 4 mm, SI was performed again. Moreover, the patients were asked about their discomfort using a visual analog scale from 1 to 10 for each side of the maxilla. Statistical analysis demonstrated no differences between quadrants at re-evaluation for clinical parameters ( p > 0.05) after 3 and 6 months. Concerning pain perception, patients described less pain on the irradiated side ( p = 0.016). In the treatment of patients with periodontitis, VIS + wIRA did not show an additional effect on the clinical outcome after 3 and 6 months. Patients described less pain on the irradiated quadrant after treatment.",2021,"In the treatment of patients with periodontitis, VIS + wIRA did not show an additional effect on the clinical outcome after 3 and 6 months.","['forty patients with untreated periodontitis', 'periodontitis patients compared with the standard therapy by subgingival instrumentation (SI', 'patients with periodontitis']","['transgingival visible light and water-filtered infrared-A (VIS + wIRA', 'Adjuvant Transgingival Therapy with Visible Light Plus', 'Water-Filtered Infrared-A (VIS + wIRA', 'SI or received only SI', 'non-surgical periodontal treatment']","['visual analog scale', 'clinical parameters (probing depths (PDs), clinical attachment level, bleeding on probing (BOP), furcation, tooth mobility, plaque control record, and papilla bleeding index', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0595817', 'cui_str': 'Subgingival route'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}]","[{'cui': 'C0242377', 'cui_str': 'Visible light'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C1532326', 'cui_str': 'Infra-red'}, {'cui': 'C1571809', 'cui_str': 'Visceral manipulation'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0595817', 'cui_str': 'Subgingival route'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0040445', 'cui_str': 'Tooth mobility'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0226964', 'cui_str': 'Structure of lingual papillae'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",40.0,0.207863,"In the treatment of patients with periodontitis, VIS + wIRA did not show an additional effect on the clinical outcome after 3 and 6 months.","[{'ForeName': 'Stefanie Anna', 'Initials': 'SA', 'LastName': 'Peikert', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Faculty of Medicine, University of Freiburg, Hugstetter Straße 55, 79106 Freiburg, Germany.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Fischer', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Faculty of Medicine, University of Freiburg, Hugstetter Straße 55, 79106 Freiburg, Germany.'}, {'ForeName': 'Anne Brigitte', 'Initials': 'AB', 'LastName': 'Kruse', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Faculty of Medicine, University of Freiburg, Hugstetter Straße 55, 79106 Freiburg, Germany.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Al-Ahmad', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Faculty of Medicine, University of Freiburg, Hugstetter Straße 55, 79106 Freiburg, Germany.'}, {'ForeName': 'Johan Peter', 'Initials': 'JP', 'LastName': 'Woelber', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Faculty of Medicine, University of Freiburg, Hugstetter Straße 55, 79106 Freiburg, Germany.'}, {'ForeName': 'Kirstin', 'Initials': 'K', 'LastName': 'Vach', 'Affiliation': 'Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center, University of Freiburg, Stefan-Meier-Straße 26, 79104 Freiburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Braun', 'Affiliation': 'Clinic for Operative Dentistry, Periodontology and Preventive Dentistry, RWTH University Aachen, Pauwelsstraße 30, 52074 Aachen, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Ratka-Krüger', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Faculty of Medicine, University of Freiburg, Hugstetter Straße 55, 79106 Freiburg, Germany.'}]","Antibiotics (Basel, Switzerland)",['10.3390/antibiotics10030251'] 2816,33802464,Influence of Antihypertensive Treatment on RAAS Peptides in Newly Diagnosed Hypertensive Patients.,"(1) Background: Recently, influences of antihypertensive treatment on the renin-angiotensin-aldosterone system (RAAS) has gained attention, regarding a possible influence on inflammatory and anti-inflammatory pathways. We aimed to study the effects of newly initiated antihypertensive drugs on angiotensin (Ang) II and Ang (1-7) as representers of two counter-regulatory axes. (2) Methods: In this randomized, open-label trial investigating RAAS peptides after the initiation of perindopril, olmesartan, amlodipine, or hydrochlorothiazide, Ang II and Ang (1-7) equilibrium concentrations were measured at 8 a.m. and 12 a.m. at baseline and after four weeks of treatment. Eighty patients were randomized (1:1:1:1 fashion). (3) Results: Between the four substances, we found significant differences regarding the concentrations of Ang II ( p < 0.0005 for 8 a.m., 12 a.m.) and Ang (1-7) ( p = 0.019 for 8 a.m., <0.0005 for 12 a.m.) four weeks after treatment start. Ang II was decreased by perindopril ( p = 0.002), and increased by olmesartan ( p < 0.0005), amlodipine ( p = 0.012), and hydrochlorothiazide ( p = 0.001). Ang (1-7) was increased by perindopril and olmesartan ( p = 0.008/0.002), but not measurably altered by amlodipine and hydrochlorothiazide ( p = 0.317/ 0.109). (4) Conclusion: The initiation of all first line antihypertensive treatments causes early and distinct alterations of equilibrium angiotensin levels. Given the additional AT1R blocking action of olmesartan, RAAS peptides shift upon initiation of perindopril and olmesartan appear to work in favor of the anti-inflammatory axis compared to amlodipine and hydrochlorothiazide.",2021,"Ang (1-7) was increased by perindopril and olmesartan ( p = 0.008/0.002), but not measurably altered by amlodipine and hydrochlorothiazide ( p = 0.317/ 0.109).","['Eighty patients', 'Newly Diagnosed Hypertensive Patients']","['amlodipine and hydrochlorothiazide', 'hydrochlorothiazide', 'perindopril, olmesartan, amlodipine, or hydrochlorothiazide, Ang II and Ang', 'perindopril and olmesartan', 'amlodipine', 'perindopril', 'Antihypertensive Treatment']",['concentrations of Ang II'],"[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}, {'cui': 'C0136123', 'cui_str': 'Perindopril'}, {'cui': 'C1098320', 'cui_str': 'olmesartan'}, {'cui': 'C0003009', 'cui_str': 'angiotensin II'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0003009', 'cui_str': 'angiotensin II'}]",80.0,0.0315148,"Ang (1-7) was increased by perindopril and olmesartan ( p = 0.008/0.002), but not measurably altered by amlodipine and hydrochlorothiazide ( p = 0.317/ 0.109).","[{'ForeName': 'Annina S', 'Initials': 'AS', 'LastName': 'Vischer', 'Affiliation': 'Hypertension Clinic, Medical Outpatient Department and Hypertension Clinic, ESH Hypertension Centre of Excellence, University Hospital Basel, 4031 Basel, Switzerland.'}, {'ForeName': 'Gabriela M', 'Initials': 'GM', 'LastName': 'Kuster', 'Affiliation': 'Clinic of Cardiology, University Hospital Basel, 4031 Basel, Switzerland.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Twerenbold', 'Affiliation': 'Clinic of Cardiology, University Hospital Basel, 4031 Basel, Switzerland.'}, {'ForeName': 'Otmar', 'Initials': 'O', 'LastName': 'Pfister', 'Affiliation': 'Clinic of Cardiology, University Hospital Basel, 4031 Basel, Switzerland.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Clinic of Cardiology, University Hospital Basel, 4031 Basel, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Villiger', 'Affiliation': 'Division of Clinical Pharmacology & Toxicology, University Hospital Basel, 4031 Basel, Switzerland.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Poglitsch', 'Affiliation': 'Attoquant Diagnostics GmbH, 1110 Vienna, Austria.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Krähenbühl', 'Affiliation': 'Division of Clinical Pharmacology & Toxicology, University Hospital Basel, 4031 Basel, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mayr', 'Affiliation': 'Hypertension Clinic, Medical Outpatient Department and Hypertension Clinic, ESH Hypertension Centre of Excellence, University Hospital Basel, 4031 Basel, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Osswald', 'Affiliation': 'Clinic of Cardiology, University Hospital Basel, 4031 Basel, Switzerland.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Haschke', 'Affiliation': 'Division of Clinical Pharmacology & Toxicology, University Hospital Basel, 4031 Basel, Switzerland.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Burkard', 'Affiliation': 'Hypertension Clinic, Medical Outpatient Department and Hypertension Clinic, ESH Hypertension Centre of Excellence, University Hospital Basel, 4031 Basel, Switzerland.'}]",Cells,['10.3390/cells10030534'] 2817,33802448,Short-Term Effect of Kinesio Taping of Lower-Leg Proprioceptive Neuromuscular Facilitation Pattern on Gait Parameter and Dynamic Balance in Chronic Stroke with Foot Drop.,"The aim of this study is to identify the effectiveness of proprioceptive neuromuscular facilitation (PNF) leg Kinesio taping on gait parameters and dynamic balance in chronic stroke patients with foot drop. A total 22 chronic stroke patients were randomly assigned to experimental (n = 11) and control groups (n = 11). All subjects underwent conventional therapy and gait training for 50 min. The experimental group additionally received KT of tibialis anterior muscle (TA) and hamstring muscles according to the PNF pattern. The control group received KT of only TA. The primary outcome measures that the gait parameter are gait velocity, cadence, step length, and stride length. Dynamic balance was measured by the timed up-and-go test (TUG) time and activity-specific balance confidence scale (ABC) as the secondary outcomes. All of the measurements were performed baseline and 24 h after intervention. Our results showed that the experimental group showed significant improvements in gait velocity, cadence, step length, stride length and TUG, and ABC score compared with the control group. We conclude that the short term effect of application of lower-leg KT according to the PNF pattern increased the gait ability and dynamic balance of chronic stroke patients with foot drop.",2021,"Our results showed that the experimental group showed significant improvements in gait velocity, cadence, step length, stride length and TUG, and ABC score compared with the control group.","['Chronic Stroke with Foot Drop', 'chronic stroke patients with foot drop', 'A total 22 chronic stroke patients']","['proprioceptive neuromuscular facilitation (PNF) leg Kinesio taping', 'conventional therapy and gait training', 'KT of tibialis anterior muscle (TA) and hamstring muscles according to the PNF pattern', 'KT of only TA', 'Kinesio Taping of Lower-Leg Proprioceptive Neuromuscular Facilitation']","['gait ability and dynamic balance', 'gait parameters and dynamic balance', 'Dynamic balance', 'timed up-and-go test (TUG) time and activity-specific balance confidence scale (ABC', 'gait velocity, cadence, step length, stride length and TUG, and ABC score', 'gait parameter are gait velocity, cadence, step length, and stride length', 'Gait Parameter and Dynamic Balance']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0085684', 'cui_str': 'Foot-drop'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0242690', 'cui_str': 'Tibialis anterior muscle structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0230446', 'cui_str': 'Both lower legs'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0429928', 'cui_str': 'Test time'}, {'cui': 'C2733457', 'cui_str': 'Activities specific balance confidence scale'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",22.0,0.0212926,"Our results showed that the experimental group showed significant improvements in gait velocity, cadence, step length, stride length and TUG, and ABC score compared with the control group.","[{'ForeName': 'Dongyun', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, Korea Su Medical Clinic, Bucheon 14643, Korea.'}, {'ForeName': 'Youngsook', 'Initials': 'Y', 'LastName': 'Bae', 'Affiliation': 'Department of Physical Therapy, College of Health Science, Gachon University, 191 Hambangmoe-ro, Yeonsu-gu, Incheon 21936, Korea.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare9030271'] 2818,33813359,Changes in prefrontal cortical activity and turning in response to dopaminergic and cholinergic therapy in Parkinson's disease: A randomized cross-over trial.,"INTRODUCTION Cholinergic dysfunction contributes to mobility deficits in Parkinson's disease (PD). People with PD rely on limited prefrontal executive-attentional resources for the control of locomotion, including turning. Cortical and behavioral responses to cholinergic augmentation during turning remains unclear. We examined prefrontal cortex (PFC) activity while turning-in-place and spatiotemporal measures of turns in response to usual dopaminergic medication and adjunct cholinergic augmentation. METHODS This study consisted of a single-site, randomized, double-blind crossover trial. Twenty PD participants were assessed in the levodopa-off state and then randomized to either levodopa + donepezil (5 mg) or levodopa + placebo treatments for two weeks followed by a 2-week washout before crossover. The primary outcome was change from off state in PFC activity while turning-in-place (assessed with functional near-infrared spectroscopy). Secondary outcomes were changes in spatiotemporal turning measures (assessed with body-worn inertial measurement units) and accuracy in the secondary task. RESULTS Nineteen participants completed the trial. While levodopa + placebo had no effect on PFC activity when turning-in-place with a dual-task, levodopa + donepezil led to a large reduction in PFC activity (effect size, -0.82). Spatiotemporal measures of turning improved with both treatments, with slightly greater effect sizes observed for levodopa + donepezil. Additionally, the accuracy in the concurrent cognitive task improved only with levodopa + donepezil (effect size, 0.63). CONCLUSION The addition of cholinergic therapy with donepezil (5 mg/day for 2 weeks) to standard dopaminergic therapy reduced the burden on prefrontal executive-attentional resources while turning with a dual-task and improved secondary task accuracy and turning.",2021,"Spatiotemporal measures of turning improved with both treatments, with slightly greater effect sizes observed for levodopa + donepezil.","['Twenty PD participants', ""Parkinson's disease (PD"", ""Parkinson's disease"", 'Nineteen participants completed the trial']","['standard dopaminergic therapy', 'levodopa\xa0+\xa0donepezil', 'donepezil', 'levodopa\xa0+\xa0placebo']","['PFC activity', 'prefrontal executive-attentional resources', 'prefrontal cortex (PFC) activity', 'change from off state in PFC activity while turning-in-place (assessed with functional near-infrared spectroscopy', 'concurrent cognitive task', 'changes in spatiotemporal turning measures (assessed with body-worn inertial measurement units) and accuracy in the secondary task']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0541749', 'cui_str': 'Does turn'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",20.0,0.256008,"Spatiotemporal measures of turning improved with both treatments, with slightly greater effect sizes observed for levodopa + donepezil.","[{'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Vitorio', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, OR, United States.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Stuart', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, OR, United States; Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Giritharan', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, OR, United States.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Quinn', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, OR, United States.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Nutt', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, OR, United States.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Mancini', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, OR, United States. Electronic address: mancinim@ohsu.edu.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2021.03.014'] 2819,33813352,Computer-delivered personalized feedback intervention for hazardous drinkers with elevated anxiety sensitivity: A pilot randomized controlled trial.,"Hazardous drinkers with emotional vulnerabilities (e.g., elevated anxiety sensitivity) remain an underserved group. This study aimed to evaluate the feasibility, acceptability, and initial efficacy of a single session remotely-delivered personalized feedback intervention (PFI) targeting alcohol (mis)use and anxiety sensitivity among college students. Hazardous drinkers with elevated anxiety sensitivity (N = 125; 76.8% female; M age  = 22.14; 66.4% racial/ethnic minorities) were randomized to receive the integrated PFI (n = 63) or attention control (n = 62). Follow-up assessments were conducted one-week, one-month and three-months post-intervention. Latent growth curve modeling was used to test pilot outcomes. It was feasible to recruit and retain hazardous drinking students with elevated anxiety sensitivity through follow-up with no group differences in retention. The integrated PFI was rated as more acceptable than the control with medium/large differences (p's < 0.004; d's = 0.54-0.80). The integrated PFI group had statistically significantly greater change in primary outcomes: motivation, hazardous alcohol use, and anxiety sensitivity (p's < 0.05; d's = 0.08-0.37) with larger within-group effect sizes (d's = 0.48-0.61) than in control (d's = 0.26-0.54). Despite a small sample size, this one-session intervention offers promise among a high-risk group of drinkers with emotional vulnerabilities. The computer-based format may allow for mass distribution of a low-cost intervention in the future; however, follow-up testing in larger samples is needed.",2021,"The integrated PFI group had statistically significantly greater change in primary outcomes: motivation, hazardous alcohol use, and anxiety sensitivity (","['Hazardous drinkers with emotional vulnerabilities (e.g., elevated anxiety sensitivity) remain an underserved group', 'college students', 'hazardous drinkers with elevated anxiety sensitivity', 'Hazardous drinkers with elevated anxiety sensitivity (N\xa0=\xa0125; 76.8% female; M age \xa0=\xa022.14; 66.4% racial/ethnic minorities']","['integrated PFI ', 'attention control', 'single session remotely-delivered personalized feedback intervention (PFI) targeting alcohol', 'Computer-delivered personalized feedback intervention']","['primary outcomes: motivation, hazardous alcohol use, and anxiety sensitivity ', 'feasibility, acceptability, and initial efficacy']","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0009622', 'cui_str': 'Computer'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0257739,"The integrated PFI group had statistically significantly greater change in primary outcomes: motivation, hazardous alcohol use, and anxiety sensitivity (","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Paulus', 'Affiliation': 'University of Pittsburgh, Department of Psychiatry, Pittsburgh, PA, 15213, USA. Electronic address: djpaulus@uh.edu.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Gallagher', 'Affiliation': 'University of Houston, Department of Psychology, Houston, TX, 77204, USA; University of Houston, Texas Institute for Measurement, Evaluation, and Statistics, Houston, TX, 77204, USA.'}, {'ForeName': 'Clayton', 'Initials': 'C', 'LastName': 'Neighbors', 'Affiliation': 'University of Houston, Department of Psychology, Houston, TX, 77204, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Zvolensky', 'Affiliation': 'University of Houston, Department of Psychology, Houston, TX, 77204, USA; The University of Texas MD Anderson Cancer Center, Department of Behavioral Science, Houston, TX, 77030, USA; Health Institute, University of Houston, Houston, TX, 77204, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2021.103847'] 2820,33812991,"Retaining diverse adults with diabetes in a long-term trial: Strategies, successes, and lessons learned.","Background Retention can be difficult in longitudinal trials, especially among minoritized groups and individuals with low socioeconomic status (SES) who may experience more barriers to research participation. Organized retention strategies may help; however, limited research has reported on this in detail. Methods We employed several strategies throughout a 15-month randomized controlled trial to encourage retention among a diverse sample of adults with type 2 diabetes. Participants were randomized to receive mobile health support for diabetes self-care for 12 months or an attention control. Participants completed assessments at 3, 6, 12, and 15 months post-baseline. We used three main categories of retention strategies: flexibility in participation (e.g., multiple methods for data collection), communication (e.g., tracking contacts), and community building (e.g., study branding, newsletters). We monitored participants' use of strategies and examined associations between participant characteristics and retention. Results Retention remained high (≥90%) at each follow-up assessment. Participants used various methods for survey completion: online (34%), in-person (31%), and mail (30%). Most (73%) used a mail-in A1c kit at least once. Multiple completion methods were important for retaining minoritized and lower SES participants who completed assessments in-person more frequently. Communication also facilitated retention; 39% of participants used a study Helpline and tracking systems helped maintain contact. Conclusions Retaining disadvantaged patients in clinical trials is necessary so findings generalize to and can benefit these populations. Retention strategies that reduce barriers to participation and engage participants and community partners can be successful. Future studies should assess the impact of retention strategies.",2021,Results Retention remained high (≥90%) at each follow-up assessment.,"['adults with type 2 diabetes', 'minoritized groups and individuals with low socioeconomic status (SES']",['mobile health support for diabetes self-care for 12\u202fmonths or an attention control'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.182241,Results Retention remained high (≥90%) at each follow-up assessment.,"[{'ForeName': 'Lyndsay A', 'Initials': 'LA', 'LastName': 'Nelson', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; Center for Health Behavior and Health Education, Vanderbilt University Medical Center, Nashville, TN, USA; Center for Diabetes Translation Research, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Williamson', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; Center for Health Behavior and Health Education, Vanderbilt University Medical Center, Nashville, TN, USA; DeBusk College of Osteopathic Medicine, Lincoln Memorial University, Knoxville, TN, USA.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'LeStourgeon', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; Center for Health Behavior and Health Education, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Lindsay S', 'Initials': 'LS', 'LastName': 'Mayberry', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; Center for Health Behavior and Health Education, Vanderbilt University Medical Center, Nashville, TN, USA; Center for Diabetes Translation Research, Vanderbilt University Medical Center, Nashville, TN, USA; Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, TN, USA. Electronic address: lindsay.mayberry@vumc.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106388'] 2821,33793460,"Interim Estimates of Vaccine Effectiveness of BNT162b2 and mRNA-1273 COVID-19 Vaccines in Preventing SARS-CoV-2 Infection Among Health Care Personnel, First Responders, and Other Essential and Frontline Workers - Eight U.S. Locations, December 2020-March 2021.","Messenger RNA (mRNA) BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) COVID-19 vaccines have been shown to be effective in preventing symptomatic COVID-19 in randomized placebo-controlled Phase III trials (1,2); however, the benefits of these vaccines for preventing asymptomatic and symptomatic SARS-CoV-2 (the virus that causes COVID-19) infection, particularly when administered in real-world conditions, is less well understood. Using prospective cohorts of health care personnel, first responders, and other essential and frontline workers* in eight U.S. locations during December 14, 2020-March 13, 2021, CDC routinely tested for SARS-CoV-2 infections every week regardless of symptom status and at the onset of symptoms consistent with COVID-19-associated illness. Among 3,950 participants with no previous laboratory documentation of SARS-CoV-2 infection, 2,479 (62.8%) received both recommended mRNA doses and 477 (12.1%) received only one dose of mRNA vaccine. † Among unvaccinated participants, 1.38 SARS-CoV-2 infections were confirmed by reverse transcription-polymerase chain reaction (RT-PCR) per 1,000 person-days. § In contrast, among fully immunized (≥14 days after second dose) persons, 0.04 infections per 1,000 person-days were reported, and among partially immunized (≥14 days after first dose and before second dose) persons, 0.19 infections per 1,000 person-days were reported. Estimated mRNA vaccine effectiveness for prevention of infection, adjusted for study site, was 90% for full immunization and 80% for partial immunization. These findings indicate that authorized mRNA COVID-19 vaccines are effective for preventing SARS-CoV-2 infection, regardless of symptom status, among working-age adults in real-world conditions. COVID-19 vaccination is recommended for all eligible persons.",2021,"† Among unvaccinated participants, 1.38 SARS-CoV-2 infections were confirmed by reverse transcription-polymerase chain reaction (RT-PCR) per 1,000 person-days.","['Using prospective cohorts of health care personnel, first responders, and other essential and frontline workers* in eight U.S. locations during December 14, 2020-March 13, 2021, CDC routinely tested for SARS-CoV-2 infections every week regardless of symptom status and at the onset of symptoms consistent with COVID-19-associated illness', '3,950 participants with no previous laboratory documentation of SARS-CoV-2 infection, 2,479 (62.8%) received both recommended mRNA doses and 477 (12.1%) received only one dose of']","['mRNA vaccine', 'BNT162b2 and mRNA-1273 COVID-19 Vaccines']",['SARS-CoV-2 Infection'],"[{'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C3178988', 'cui_str': 'Emergency First Responders'}, {'cui': 'C0205224', 'cui_str': 'Essential'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0007670', 'cui_str': 'Centers for Disease Control and Prevention (U.S.)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",3950.0,0.0804178,"† Among unvaccinated participants, 1.38 SARS-CoV-2 infections were confirmed by reverse transcription-polymerase chain reaction (RT-PCR) per 1,000 person-days.","[{'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Thompson', 'Affiliation': ''}, {'ForeName': 'Jefferey L', 'Initials': 'JL', 'LastName': 'Burgess', 'Affiliation': ''}, {'ForeName': 'Allison L', 'Initials': 'AL', 'LastName': 'Naleway', 'Affiliation': ''}, {'ForeName': 'Harmony L', 'Initials': 'HL', 'LastName': 'Tyner', 'Affiliation': ''}, {'ForeName': 'Sarang K', 'Initials': 'SK', 'LastName': 'Yoon', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Meece', 'Affiliation': ''}, {'ForeName': 'Lauren E W', 'Initials': 'LEW', 'LastName': 'Olsho', 'Affiliation': ''}, {'ForeName': 'Alberto J', 'Initials': 'AJ', 'LastName': 'Caban-Martinez', 'Affiliation': ''}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Fowlkes', 'Affiliation': ''}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Lutrick', 'Affiliation': ''}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Kuntz', 'Affiliation': ''}, {'ForeName': 'Kayan', 'Initials': 'K', 'LastName': 'Dunnigan', 'Affiliation': ''}, {'ForeName': 'Marilyn J', 'Initials': 'MJ', 'LastName': 'Odean', 'Affiliation': ''}, {'ForeName': 'Kurt T', 'Initials': 'KT', 'LastName': 'Hegmann', 'Affiliation': ''}, {'ForeName': 'Elisha', 'Initials': 'E', 'LastName': 'Stefanski', 'Affiliation': ''}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Edwards', 'Affiliation': ''}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Schaefer-Solle', 'Affiliation': ''}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Grant', 'Affiliation': ''}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Ellingson', 'Affiliation': ''}, {'ForeName': 'Holly C', 'Initials': 'HC', 'LastName': 'Groom', 'Affiliation': ''}, {'ForeName': 'Tnelda', 'Initials': 'T', 'LastName': 'Zunie', 'Affiliation': ''}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Thiese', 'Affiliation': ''}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Ivacic', 'Affiliation': ''}, {'ForeName': 'Meredith G', 'Initials': 'MG', 'LastName': 'Wesley', 'Affiliation': ''}, {'ForeName': 'Julie Mayo', 'Initials': 'JM', 'LastName': 'Lamberte', 'Affiliation': ''}, {'ForeName': 'Xiaoxiao', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Phillips', 'Affiliation': ''}, {'ForeName': 'Kimberly D', 'Initials': 'KD', 'LastName': 'Groover', 'Affiliation': ''}, {'ForeName': 'Young M', 'Initials': 'YM', 'LastName': 'Yoo', 'Affiliation': ''}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Gerald', 'Affiliation': ''}, {'ForeName': 'Rachel T', 'Initials': 'RT', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Meghan K', 'Initials': 'MK', 'LastName': 'Herring', 'Affiliation': ''}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Joseph', 'Affiliation': ''}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Beitel', 'Affiliation': ''}, {'ForeName': 'Tyler C', 'Initials': 'TC', 'LastName': 'Morrill', 'Affiliation': ''}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Mak', 'Affiliation': ''}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rivers', 'Affiliation': ''}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Harris', 'Affiliation': ''}, {'ForeName': 'Danielle R', 'Initials': 'DR', 'LastName': 'Hunt', 'Affiliation': ''}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Arvay', 'Affiliation': ''}, {'ForeName': 'Preeta', 'Initials': 'P', 'LastName': 'Kutty', 'Affiliation': ''}, {'ForeName': 'Alicia M', 'Initials': 'AM', 'LastName': 'Fry', 'Affiliation': ''}, {'ForeName': 'Manjusha', 'Initials': 'M', 'LastName': 'Gaglani', 'Affiliation': ''}]",MMWR. Morbidity and mortality weekly report,['10.15585/mmwr.mm7013e3'] 2822,33811392,Development of an assessment measure for sexual disinhibition in dementia.,"OBJECTIVE Sexual disinhibition (SD), a neuropsychiatric symptom characterized by sexually inappropriate comments and/or behaviors, remains under identified in dementia, possibly due to a lack of standardized assessment methods. A recent systematic review of measures used to assess SD proposed four behavioral domains and identified the need for a population-specific measure. The present study addressed this by examining the underlying factor structure of SD to create a new caregiver-report measure. METHODS Dementia caregivers (n = 622) recruited online were randomly assigned to Initial Validation (n = 311) or Cross-Validation (n = 311) groups. RESULTS Initial Validation revealed five behavioral domains that served as provisional scales for cross-validation, leading to measure development. CONCLUSIONS The current study is the first to statistically evaluate the underlying factor structure of SD, resulting in a new measure that can help better characterize and identify SD.",2021,"The present study addressed this by examining the underlying factor structure of sexual disinhibition to create a new caregiver-report measure. ","['Sexual Disinhibition in Dementia', 'Dementia caregivers (n=622) recruited online were randomly assigned to Initial Validation (n=311) or Cross-Validation (n=311) groups']",[],[],"[{'cui': 'C0562557', 'cui_str': 'Sexually disinhibited behavior'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],[],622.0,0.0790599,"The present study addressed this by examining the underlying factor structure of sexual disinhibition to create a new caregiver-report measure. ","[{'ForeName': 'Kimberly R', 'Initials': 'KR', 'LastName': 'Chapman', 'Affiliation': 'Department of Psychological Sciences, Kent State University, Kent, Ohio, USA.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Tremont', 'Affiliation': 'Department of Psychiatry, Rhode Island Hospital, Providence, Rhode Island, USA.'}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Spitznagel', 'Affiliation': 'Department of Psychological Sciences, Kent State University, Kent, Ohio, USA.'}]",International journal of geriatric psychiatry,['10.1002/gps.5552'] 2823,33811385,A prospective randomized tandem gastroscopy pilot study of linked color imaging versus white light imaging for detection of upper gastrointestinal lesions.,"BACKGROUND AND AIM Gastrointestinal (GI) lesions may have subtle morphological changes. Linked color imaging (LCI) combines narrow-band wavelength light and white light imaging (WLI) in appropriate balance to enhance lesion detection. We compared the detection rates of upper GI lesions using LCI and WLI. METHOD Patients were randomized in a 1:1 ratio to receive tandem gastroscopy with WLI inspection followed by LCI, or vice versa. Endoscopic examination was performed using the EG-L590ZW gastroscope and the LASEREO endoscope system (Fujifilm Co., Tokyo, Japan). Histology was reported by a specialist GI pathologist blinded to the technique of lesion detection and was used as the gold standard for diagnosis. RESULTS Ninety patients (mean age 66.8 years, 51.5% male patients) were randomized to either LCI examination first followed by WLI (LCI-WLI), or vice versa (WLI-LCI). An 18.9% of gastroscopies in the study were for surveillance of previously known gastric cancer precursors. Ten patients (11.1%) had a history of Helicobacter pylori infection. There was no significant difference in the time taken for examination under LCI (311 ± 96 s) and WLI (342 ± 86 s) (P = 0.700). LCI detection rates were higher than WLI detection rates for gastric cancer precursors such as atrophic gastritis (2.19% vs 0.55%) (P < 0.01) and intestinal metaplasia (19.73% vs 7.67%) (P < 0.01). Both sensitivity (82.74% vs 50.96%) and specificity (98.71% vs 96.10%) of LCI were higher than WLI for detection of upper GI lesions. CONCLUSIONS Linked color imaging had better detection rates, sensitivity, and specificity for detection of upper GI lesions compared with WLI.",2021,There was no significant difference in the time taken for examination under LCI (311± 96 seconds) and WLI (342± 86 seconds) (p=0.700).,"['Patients', '90 patients (mean age 66.8 years, 51.5% male']","['LCI examination first followed by WLI (LCI-WLI), or vice versa (WLI-LCI', 'linked color imaging vs white light imaging', 'Linked color imaging (LCI) combines narrow-band wavelength light and white light (WLI', 'tandem gastroscopy with WLI inspection followed by LCI, or vice versa']","['detection rates, sensitivity and specificity for detection of upper GI lesions', 'detection rates of upper GI lesions', 'atrophic gastritis', 'LCI detection rates', 'intestinal metaplasia', 'Both sensitivity', 'specificity', 'history of H. pylori infection', 'time taken for examination under LCI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517844', 'cui_str': '66.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0449819', 'cui_str': 'Wavelength'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0017195', 'cui_str': 'Endoscopy of stomach'}, {'cui': 'C0199219', 'cui_str': 'Inspection'}]","[{'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C3203348', 'cui_str': 'Upper gastrointestinal tract structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0017154', 'cui_str': 'Atrophic gastritis'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0334037', 'cui_str': 'Intestinal metaplasia'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0769435,There was no significant difference in the time taken for examination under LCI (311± 96 seconds) and WLI (342± 86 seconds) (p=0.700).,"[{'ForeName': 'Clement Chun Ho', 'Initials': 'CCH', 'LastName': 'Wu', 'Affiliation': 'Department of Gastroenterology and Hepatology, Changi General Hospital, Singapore.'}, {'ForeName': 'Vikneswaran', 'Initials': 'V', 'LastName': 'Namasivayam', 'Affiliation': 'Department of Gastroenterology and Hepatology, Singapore General Hospital, Singapore.'}, {'ForeName': 'James Weiquan', 'Initials': 'JW', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology and Hepatology, Changi General Hospital, Singapore.'}, {'ForeName': 'Chris Jl', 'Initials': 'CJ', 'LastName': 'Khor', 'Affiliation': 'Department of Gastroenterology and Hepatology, Singapore General Hospital, Singapore.'}, {'ForeName': 'Kwong Ming', 'Initials': 'KM', 'LastName': 'Fock', 'Affiliation': 'Department of Gastroenterology and Hepatology, Changi General Hospital, Singapore.'}, {'ForeName': 'Ngai Moh', 'Initials': 'NM', 'LastName': 'Law', 'Affiliation': 'Department of Gastroenterology and Hepatology, Changi General Hospital, Singapore.'}, {'ForeName': 'Lai Mun', 'Initials': 'LM', 'LastName': 'Wang', 'Affiliation': 'Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Tiing Leong', 'Initials': 'TL', 'LastName': 'Ang', 'Affiliation': 'Department of Gastroenterology and Hepatology, Changi General Hospital, Singapore.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15515'] 2824,33810808,Effects of pomegranate juice (Punica Granatum) on inflammatory biomarkers and complete blood count in patients with COVID-19: a structured summary of a study protocol for a randomized clinical trial.,"OBJECTIVES This study is conducted to investigate efficacy of pomegranate juice on inflammatory biomarkers, C-reactive protein (CRP), interleukin 6(IL-6), erythrocyte sedimentation rate (ESR) and complete blood count (CBC) in hospitalized patients with mild to moderate coronavirus disease 2019 (COVID- 19). TRIAL DESIGN This is a randomized, placebo-controlled, double-blind, parallel 2-arm (1:1 ratio) clinical trial. PARTICIPANTS Patients with COVID-19 admitted to hospitals in Yasuj City, Kohgiluyeh and Boyer-Ahmad Province, Iran. INCLUSION CRITERIA Informed consent Patients 18 years of age or older Diagnosis of COVID-19 based on real-time polymerase chain reaction (RT-PCR) test EXCLUSION CRITERIA: Pregnancy or lactation Immunoglobulin A (IgA) level <61 mg/dl Disseminated intravascular coagulation or any other types of coagulopathy Severe congestive heart failure Participation in any clinical trial within 30 days prior to enrollment in this RCT Other contraindications determined by the specialist. INTERVENTION AND COMPARATOR Intervention: 500 ml pomegranate juice and standard of care hospital treatment for COVID-19 Comparator: matching placebo containing 500 ml of red water and standard of care hospital treatment for COVID-19 Both intervention and comparator to be taken twice a day, after lunch and dinner, for 14 days. CRITERIA FOR DISCONTINUING Transfer of patients to intensive care unit (ICU) Death Unwillingness to continue participating in the study MAIN OUTCOMES: The main outcomes of this study are levels of inflammatory biomarkers, CRP, IL-6, ESR, and CBC after 14 days of treatment. RANDOMIZATION Eligible patients will be randomly assigned into the intervention or control group in a 1:1 ratio. Randomization will be performed based on 8 permuted blocks with block sizes of 6 and they will be stratified according to sex and age categories. Randomization sequences will be prepared by the trial's pharmacist using computer-generated random numbers. BLINDING (MASKING) This study is a double-blind clinical trial (participant, researcher). The pomegranate juice and placebo juice are packaged in identical bottles, and the researcher and all the patients will be unaware of the study assignment until the end of the study. To ensure blinding, the randomization sequences will be kept in identical, opaque, sealed, and sequentially numbered envelopes. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE) The calculated total sample size is 48 patients, with 24 patients assigned into each group. TRIAL STATUS The protocol is Version 1.0, on March 3, 2021. Recruitment started on February 28, 2021, and is anticipated to be completed by May 21, 2021. TRIAL REGISTRATION The Name of registering trial Effects of Pomegranate Juice (Punica Granatum) on Inflammatory Biomarkers and CBC in Patients with COVID-19: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Iranian registry of clinical trials (IRCT) Registration Number: IRCT20150711023153N2 Date of Trial Registration February 28, 2021, retrospectively registered FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials҆ website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2021,"The main outcomes of this study are levels of inflammatory biomarkers, CRP, IL-6, ESR, and CBC after 14 days of treatment. ","['Patients with COVID-19 admitted to hospitals in Yasuj City, Kohgiluyeh and Boyer-Ahmad Province, Iran.\nINCLUSION CRITERIA\n\n\nInformed consent Patients 18 years of age or older Diagnosis of COVID-19 based on real-time polymerase chain reaction (RT-PCR) test EXCLUSION CRITERIA', 'Patients with COVID-19', 'hospitalized patients with mild to moderate coronavirus disease 2019 (COVID- 19', 'Registration Number', 'patients with COVID-19', '48 patients, with 24 patients assigned into each group', 'Iranian registry of clinical trials (IRCT']","['pomegranate juice (Punica Granatum', 'Pomegranate Juice (Punica Granatum', 'placebo', 'Immunoglobulin A (IgA) level <61 mg/dl Disseminated intravascular coagulation', 'Placebo']","['Inflammatory Biomarkers and CBC', 'inflammatory biomarkers, C-reactive protein (CRP), interleukin 6(IL-6), erythrocyte sedimentation rate (ESR) and complete blood count (CBC', 'inflammatory biomarkers and complete blood count', 'Pregnancy or lactation', 'levels of inflammatory biomarkers, CRP, IL-6, ESR, and CBC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1327962', 'cui_str': 'POMEGRANATE JUICE'}, {'cui': 'C1509685', 'cui_str': 'POMEGRANATE FRUIT EXTRACT'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0012739', 'cui_str': 'Disseminated intravascular coagulation'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0009555', 'cui_str': 'Complete blood count'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",,0.75069,"The main outcomes of this study are levels of inflammatory biomarkers, CRP, IL-6, ESR, and CBC after 14 days of treatment. ","[{'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Yousefi', 'Affiliation': 'Department of Nutrition, School of Health and nutrition, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Sadriirani', 'Affiliation': 'Department of Nutrition, School of Health and nutrition, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Azizollah', 'Initials': 'A', 'LastName': 'PourMahmoudi', 'Affiliation': 'Department of Nutrition, School of Health and nutrition, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Mahmoodi', 'Affiliation': 'Department of Nutrition, School of Health and nutrition, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Bahar', 'Initials': 'B', 'LastName': 'Samimi', 'Affiliation': 'Department of Nutrition, School of Health and nutrition, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Mahboobe', 'Initials': 'M', 'LastName': 'Hosseinikia', 'Affiliation': 'Department of Nutrition, School of Health and nutrition, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Zaker', 'Initials': 'Z', 'LastName': 'Saeedinezhad', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Seyed Bahman', 'Initials': 'SB', 'LastName': 'Panahande', 'Affiliation': 'Department of Nutrition, School of Health and nutrition, Yasuj University of Medical Sciences, Yasuj, Iran. panahande.b@gmail.com.'}]",Trials,['10.1186/s13063-021-05194-9'] 2825,33810796,"Virtualized clinical studies to assess the natural history and impact of gut microbiome modulation in non-hospitalized patients with mild to moderate COVID-19 a randomized, open-label, prospective study with a parallel group study evaluating the physiologic effects of KB109 on gut microbiota structure and function: a structured summary of a study protocol for a randomized controlled study.","OBJECTIVES These 2 parallel studies (K031 and K032) aim to evaluate the safety of KB109 in addition to supportive self-care (SSC) compared with SSC alone in outpatients with mild to moderate coronavirus disease 2019 (COVID-19). KB109 is a novel synthetic glycan that was formulated to modulate the gut microbiome composition and metabolic output in order to increase beneficial short-chain fatty acid (SCFA) production in the gut. The K031 study is designed to evaluate the safety of KB109 and characterize its impact on the natural progression of COVID-19 in patients with mild to moderate disease. The K032 study is evaluating the effect of KB109 on the gut microbiota structure and function in this same patient population. Additionally, both studies are evaluating measures of health care utilization, quality of life (QOL), laboratory indices, biomarkers of inflammation, and serological measures of immunity in patients who received SSC alone or with KB109. Noteworthy aspects of these outpatient studies include study design measures aimed at limiting in-person interactions to minimize the risk of infection spread, such as use of online diaries, telemedicine, and at-home sample collection. STUDY DESIGN K031 and K032 are randomized, controlled, open-label, clinical food studies. PARTICIPANTS Inclusion Criteria: • Adults ≥18 years of age • Patients willing and able to give informed consent • Screening/randomization telemedicine visit within 2 days of testing positive test for COVID-19 ○ In K031 study, symptomatic patients at COVID-19 testing must report new or worsening symptoms at baseline that have not been present for more than 5 days ▪ Cardinal COVID-19 symptoms include fever, chills/repeated shaking with chills, cough, shortness of breath, headache, muscle pain, anosmia/ageusia, and sore throat. The 5 additional symptoms include gastrointestinal (GI) disturbance/symptoms (other than diarrhea), diarrhea, fatigue, nasal congestion, and chest tightness ○ In K031, at COVID-19 testing, pre-symptomatic patients must report new cardinal COVID-19 symptoms within 7 days of a positive test and they must be screened and randomized within 5 days of developing symptoms • Mild to moderate COVID-19 and self-reported outpatient management ○ In K032, mild to moderate COVID-19 was defined as having the following symptoms for no more than 72 hours before COVID-19 testing: a self- reported fever or cough (new or exacerbated) or presence of at least 2 of the following: anosmia, sore throat, or nasal congestion • Ability to adhere to the study visit schedule and other protocol requirements • Consistent internet or cell phone access with a data plan and access to a smartphone, tablet, or computer • The K031 and K032 studies are currently being conducted at 17 clinical institutions throughout the United States. EXCLUSION CRITERIA • In the primary investigator's (PI) judgement, patients likely to require hospitalization for COVID-19 • Patients who are hospitalized for in-patient treatment or currently being evaluated for potential hospitalization at the time of informed consent for conditions other than COVID-19 • History of chronic lung disease with chronic hypoxia • History of documented cirrhosis or end-stage liver disease • Ongoing requirement for oxygen therapy • Shortness of breath in resting position • Diagnosis of sleep apnea requiring bilevel positive airway pressure (BIPAP)/continuous positive airway pressure (CPAP) • Female patients who are pregnant, trying to become pregnant, or lactating • Concurrent use of immunomodulatory agent within 12 months; systemic antibiotics, antifungals, or antivirals for treatment of active infection within 28 days; systemic immunosuppressive therapy within 3 months; or drugs or other compounds that modulate GI motility (eg, stool softeners, laxatives, or fiber supplements) taken currently, or within 7 days. Antacid (histamine 2 blockers and proton pump inhibitors) and antidiarrheal agents are not prohibited • History of GI surgery (6 months prior to randomization), including but not limited to bariatric surgery and bowel resection, or history of, or active GI disease(s) that may affect assessment of tolerability, including but not limited to inflammatory bowel disease, irritable bowel syndrome, autoimmune disease, or GI malignancy • Participation in an interventional clinical trial or use of any investigational agent within 30 days before randomization • Clinically significant or uncontrolled concomitant medical condition that would put the patient at risk or jeopardize the objectives of the study in the opinion of the PI • In the opinion of the PI, patient unlikely for any reason to be able to comply with study procedures • Contraindications, sensitivities, or known allergy to the use of the study product or its components INTERVENTION AND COMPARATOR: Patients will be randomized (1,1) to receive either SSC and KB109 or SSC alone. During SSC, patients should follow the steps as instructed by their healthcare provider to care for themselves and protect other people in the home and community from potentially contracting COVID-19. Management of COVID-19-related symptoms with over-the-counter cough, cold, and anti-pyretic medications by patients is permitted in accordance with the medications' respective drug facts label or as instructed by the patient's healthcare provider. Following randomization, patients assigned to receive KB109 and SSC will receive a Kaleido Biosciences, Inc at-home study kit including a thermometer, pulse oximeter, and KB109. During the Intake Period (days 1-14), KB109 will be reconstituted in water by the patient and consumed by the patient twice daily (at least 8 hours apart), following an up-titration dosing schedule: Days 1 to 2: 9 g twice daily for a total daily dose of 18 g Days 3 to 4: 18 g twice daily for a total daily dose of 36 g Days 5 to 14: 36 g twice daily for a total daily dose of 72 g During the intake period, patients will record their daily COVID-19-related symptoms, selected COVID-19 signs (as self-measured using the provided thermometer and pulse oximeter), responses to questions related to QOL measures, health care use measures, and concomitant medications taken in the previous 24 hours. Wellness visits by telephone will be conducted between days 1 and 14 to follow up on patient's health status and to ascertain compliance with KB109 and completion of questions. On day 14, all patients will undergo a telemedicine visit where the following will be conducted: abbreviated physical examination, assessment of safety and other protocol-specified measures of health, and an evaluation of whether follow-up treatment is recommended owing to a progression of COVID-19 symptoms. If feasible, blood samples for clinical chemistries, biomarkers and serological measure of immunity, and nasal/oropharyngeal swabs for quantitative viral load assessments will be collected. Beginning on day 15, patients in both groups will enter the follow-up period (days 15-35) where COVID-19 signs, symptoms, and health care use indices will be collected. Wellness visits by telephone will be conducted on days 21, 28, and 35 to follow-up on the patient's health status. On day 35, all patients will undergo a telemedicine visit where the same information as the day 14 telemedicine visit will be collected, including any blood samples. MAIN OUTCOMES The primary outcome for the K031 and K032 studies is to evaluate the safety of KB109 in addition to SSC compared with SSC alone in outpatients with mild to moderate COVID-19 by assessing the number of patients experiencing KB109-related treatment-emergent adverse events (TEAEs) during the study. K031 will also evaluate duration of symptoms among outpatients with mild to moderate COVID-19. This will be as an assessment made during the intake and/or follow-up periods of the following: • Time to resolution of the 13 overall and the 8 cardinal COVID-19-related symptoms from day 1 until the day at which the composite score of the 13 overall and 8 cardinal COVID-19-related symptoms becomes 0 or 1 and remains at 0 or 1 for the rest of the intake period and for the follow-up period • Proportion of patients with a reduction from baseline in each of the 13 overall COVID-19-related symptoms • Proportion of patients in whom symptoms (present at baseline) become absent for each of the 13 overall COVID-19-related symptoms • Change from baseline in the overall composite score of the 13 overall COVID-19-related symptoms and the 8 cardinal COVID-19-related symptoms • Time to resolution of fever (defined as from day 1 until the day at which a patient's daily maximum temperature achieves and remains below 100.4°F without antipyretic medication) • Proportion of patients with oxygen saturation <95% and <98% on days 14 and 35 • Measures collected from the health care provider wellness visits • Proportion of patients experiencing hospital admissions (all cause and COVID-19-related) • Health care use K032 will evaluate the effect of KB109 in addition to SSC compared with SSC alone on the gut microbiota structure and function in outpatients with mild to moderate COVID-19. Before days 1, 14, and 35, microbiota structure (eg, magnitude of change in gut microbiome structure, composition of gut microbiome) will be analysed by methods such as nucleic acid sequencing and gut microbiome function will be analysed via levels of stool inflammatory biomarkers (eg, lipocalin) and gut microbiome metabolites (eg, SCFA). The health of outpatients with mild to moderate COVID-19 will be evaluated during the intake and follow- up periods by: measures of QOL; measures collected from the healthcare provider wellness visits; the proportion of patients experiencing hospital admissions; health care use, the proportions of patients with oxygen saturation <95% and <98%, and the proportion of patients with temperature below 100.4 °F without an anti-pyretic medication. Potential exploratory outcome measures may include: changes from baseline (day 1) in laboratory measures, specific biomarkers of infection, serology, inflammation (eg, D-dimer, lipocalin, cytokines, IgM/IgG sero-conversion, and neutralization assays), and viral load in outpatients with mild to moderate COVID-19 in the presence and absence of KB109. RANDOMISATION All patients deemed eligible for the studies will be randomized in a 1:1 ratio to KB109 in addition to SSC or SSC alone group using an interactive response technology system. Randomization will be stratified by study site/center, age groups (≥18-<45 years, ≥45-<65 years, ≥65 years), and comorbidity status (yes, no). BLINDING (MASKING) These studies are open-label; therefore, no blinding is necessary. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) K031 will enroll approximately 350 to 400 (175-200 patients per group) whereas K032 will enroll approximately 50 patients (25 per group). STUDY STATUS K031 protocol version 4, December 9, 2020; recruitment started in August, 2020, and the study is estimated to be completed in March 2021. This study is active and enrollment was completed in January, 2021. K032 protocol version 2, June 30, 2020; recruitment is estimated to start in July, 2020. This study is recruiting and the study is estimated to be completed in March 2021. STUDY REGISTRATION K031 is registered with the US National Library of Medicine, Identifier NCT04414124 as of June 4, 2020. K032 is registered with the US National Library of Medicine, Identifier NCT04486482 as of July 24, 2020. FULL PROTOCOL The full protocols are attached as additional files (Additional files 1 and 2), accessible from the ClinicalTrials.gov website. In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocols. The study protocols have been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional files 3 and 4).",2021,"The health of outpatients with mild to moderate COVID-19 will be evaluated during the intake and follow- up periods by: measures of QOL; measures collected from the healthcare provider wellness visits; the proportion of patients experiencing hospital admissions; health care use, the proportions of patients with oxygen saturation <95% and <98%, and the proportion of patients with temperature below 100.4 °F without an anti-pyretic medication.","['Adults ≥18 years of age • Patients willing and able to give informed consent • Screening/randomization telemedicine visit within 2 days of testing positive test for COVID-19 ○', 'K031 will enroll approximately 350 to 400 (175-200 patients per group) whereas K032 will enroll approximately 50 patients (25 per group', 'patients experiencing hospital admissions; health care use, the proportions of patients with oxygen saturation <95% and <98%, and the proportion of patients with temperature below 100.4 °F without an anti-pyretic medication', 'outpatients with mild to moderate COVID-19', 'K031 protocol version 4, December 9, 2020; recruitment started in August, 2020, and the study is estimated to be completed in March 2021', 'patients who received SSC alone or with KB109', 'K031 and K032', 'Inclusion Criteria: •', 'patients with oxygen saturation <95% and <98% on days 14 and 35 • Measures collected from the health care provider wellness visits', '17 clinical institutions throughout the United States', 'Female patients who are pregnant, trying to become pregnant, or lactating •', 'patients with mild to moderate disease', 'outpatients with mild to moderate coronavirus disease 2019 (COVID-19', 'non-hospitalized patients with mild to moderate COVID-19', 'patients experiencing hospital admissions (all cause and COVID-19-related) •']","['SSC and KB109 or SSC alone', 'supportive self-care (SSC', 'sleep apnea requiring bilevel positive airway pressure (BIPAP)/continuous positive airway pressure (CPAP) •', 'SSC alone', 'oxygen therapy •', 'smartphone, tablet, or computer •', 'KB109', 'Antacid (histamine 2 blockers and proton pump inhibitors', 'KB109 and SSC']","['gastrointestinal (GI) disturbance/symptoms (other than diarrhea), diarrhea, fatigue, nasal congestion, and chest tightness ○', 'Shortness of breath in resting position •', 'fever, chills/repeated shaking with chills, cough, shortness of breath, headache, muscle pain, anosmia/ageusia, and sore throat', 'Time to resolution of fever', 'anosmia, sore throat, or nasal congestion •', 'health care utilization, quality of life (QOL), laboratory indices, biomarkers of inflammation, and serological measures of immunity', 'gut microbiota structure and function', 'safety of KB109', ' changes from baseline (day 1) in laboratory measures, specific biomarkers of infection, serology, inflammation (eg, D-dimer, lipocalin, cytokines, IgM/IgG sero-conversion, and neutralization assays), and viral load']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]","[{'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C1611149', 'cui_str': 'Bilevel positive airway pressure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0003138', 'cui_str': 'Antacid'}, {'cui': 'C0019588', 'cui_str': 'Histamine'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}]","[{'cui': 'C0232459', 'cui_str': 'Abnormal digestive tract function'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion'}, {'cui': 'C0232292', 'cui_str': 'Tight chest'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0085593', 'cui_str': 'Chill'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0003126', 'cui_str': 'Loss of sense of smell'}, {'cui': 'C2364111', 'cui_str': 'Loss of taste'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205473', 'cui_str': 'Serologic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0020964', 'cui_str': 'Immune status'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0036743', 'cui_str': 'Serologic test'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C1956074', 'cui_str': 'Lipocalin'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}]",,0.0966633,"The health of outpatients with mild to moderate COVID-19 will be evaluated during the intake and follow- up periods by: measures of QOL; measures collected from the healthcare provider wellness visits; the proportion of patients experiencing hospital admissions; health care use, the proportions of patients with oxygen saturation <95% and <98%, and the proportion of patients with temperature below 100.4 °F without an anti-pyretic medication.","[{'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Haran', 'Affiliation': 'Department of Emergency Medicine, Department of Microbiology and Physiological Systems, Clinical Director of the Center for Microbiome Research, University of Massachusetts Medical School, UMass Memorial Medical Group, Worcester, MA, USA. johnP.Haran@umassmemorial.org.'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Pinero', 'Affiliation': 'Hope Clinical Trials, Miami, FL, USA.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Kaleido Biosciences, Inc, Lexington, MA, USA.'}, {'ForeName': 'Norma Alonzo', 'Initials': 'NA', 'LastName': 'Palma', 'Affiliation': 'Kaleido Biosciences, Inc, Lexington, MA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wingertzahn', 'Affiliation': 'Kaleido Biosciences, Inc, Lexington, MA, USA.'}]",Trials,['10.1186/s13063-021-05157-0'] 2826,33802286,Effects of a Cognitive Rehabilitation Programme on the Independence Performing Activities of Daily Living of Persons with Dementia-A Pilot Randomized Controlled Trial.,"BACKGROUND In all types of dementia, cognitive abilities are affected, behaviour is altered and functional capacity is progressively lost. This cognitive deterioration manifests in the decrease of abilities required to perform the activities of daily living (ADL). The objective of this pilot study was to assess the effect of an Occupational Therapy programme based on the training of ADL through cognitive stimulation on the independence of ADL of persons with dementia. METHODS Institutionalized older adults with major neurocognitive disorder or dementia (N = 58) were randomly allocated to receive either the Occupational Therapy ADL cognitive stimulation programme or conventional Occupational Therapy. The cognitive level and the independence level performing ADL were measured at baseline (week 0), after 5 weeks of treatment (week 5) and after 6 weeks of follow up (week 12). A value of p < 0.05 and α = 0.0025 (Bonferroni correction) was considered as statistically significant. RESULTS The results obtained showed improvements in the level of independence performing ADLs in the intervention group compared to the control group ( p = 0.006). The improvements were seen in relation to feeding ( p = 0.001), dressing ( p = 0.005) and bladder and bowel incontinence ( p = 0.003), the changes observed in feeding are statistically significant. However, those improvements were not maintained after the follow up period. There were no significant changes in relation to the cognitive level ( p = 0.741). CONCLUSIONS Occupational Therapy based on ADL cognitive stimulation can have a positive effect, increasing the independence of subjects with major neurocognitive disorder or dementia who are institutionalised.",2021,"The improvements were seen in relation to feeding ( p = 0.001), dressing ( p = 0.005) and bladder and bowel incontinence ( p = 0.003), the changes observed in feeding are statistically significant.","['Institutionalized older adults with major neurocognitive disorder or dementia (N = 58', 'Daily Living of Persons with Dementia', 'persons with dementia', 'subjects with major neurocognitive disorder or dementia who are institutionalised']","['Occupational Therapy programme', 'Occupational Therapy ADL cognitive stimulation programme or conventional Occupational Therapy', 'Cognitive Rehabilitation Programme']","['level of independence performing ADLs', 'cognitive level and the independence level performing ADL', 'cognitive level', 'bladder and bowel incontinence']","[{'cui': 'C0562359', 'cui_str': 'Institutionalized'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4087461', 'cui_str': 'Major neurocognitive disorder'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0150174', 'cui_str': 'Cognitive stimulation'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}]",58.0,0.0259038,"The improvements were seen in relation to feeding ( p = 0.001), dressing ( p = 0.005) and bladder and bowel incontinence ( p = 0.003), the changes observed in feeding are statistically significant.","[{'ForeName': 'María', 'Initials': 'M', 'LastName': 'Jiménez Palomares', 'Affiliation': 'ADOLOR Research Group, Department of Medical-Surgical Therapy, Medicine Faculty, Extremadura University, 06006 Badajoz, Spain.'}, {'ForeName': 'María Victoria', 'Initials': 'MV', 'LastName': 'González López-Arza', 'Affiliation': 'ADOLOR Research Group, Department of Medical-Surgical Therapy, Medicine Faculty, Extremadura University, 06006 Badajoz, Spain.'}, {'ForeName': 'Elisa María', 'Initials': 'EM', 'LastName': 'Garrido Ardila', 'Affiliation': 'ADOLOR Research Group, Department of Medical-Surgical Therapy, Medicine Faculty, Extremadura University, 06006 Badajoz, Spain.'}, {'ForeName': 'Trinidad', 'Initials': 'T', 'LastName': 'Rodríguez Domínguez', 'Affiliation': 'ROBOLAB Research Group, Medical-Surgical Therapy Department, Nursing and Occupational Therapy Faculty, Extremadura University, 10003 Cáceres, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Rodríguez Mansilla', 'Affiliation': 'ADOLOR Research Group, Department of Medical-Surgical Therapy, Medicine Faculty, Extremadura University, 06006 Badajoz, Spain.'}]",Brain sciences,['10.3390/brainsci11030319'] 2827,33802219,Supplementation with Octacosanol Affects the Level of PCSK9 and Restore Its Physiologic Relation with LDL-C in Patients on Chronic Statin Therapy.,"Dietary supplementation with sugar cane derivates may modulate low-density lipoprotein cholesterol (LDL-C) and proprotein convertase subtilisin/kexin type 9 (PCSK9) levels. The purpose of this study was to determine if dietary supplement (DS), containing Octacosanol (20 mg) and vitamin K2 (45 µg), could restore the disrupted physiologic relation between LDL-C and serum PCSK9. Double-blind, randomized, placebo-controlled, single-center study including 87 patients on chronic atorvastatin therapy was conducted. Eighty-seven patients were randomized to receive DS ( n = 42) or placebo ( n = 45), and followed for 13 weeks. Serum PCSK9 levels, lipid parameters and their relationship were the main efficacy endpoints. The absolute levels of PCSK9 and LDL-C were not significantly different from baseline to 13 weeks. However, physiologic correlation between % change of PCSK9 and % change of LDL-C levels was normalized only in the group of patients treated with DS ( r = 0.409, p = 0.012). This study shows that DS can restore statin disrupted physiologic positive correlation between PCSK9 and LDL-C. Elevated PCSK9 level is an independent risk factor so controlling its rise by statins may be important in prevention of cardiovascular events.",2021,The absolute levels of PCSK9 and LDL-C were not significantly different from baseline to 13 weeks.,"['Eighty-seven patients', 'Patients on Chronic Statin Therapy', '87 patients on']","['dietary supplement (DS), containing Octacosanol (20 mg) and vitamin K2', 'Octacosanol', 'chronic atorvastatin therapy', 'placebo', 'DS', 'Dietary supplementation with sugar cane derivates']","['low-density lipoprotein cholesterol (LDL-C) and proprotein convertase subtilisin/kexin type 9 (PCSK9) levels', 'Serum PCSK9 levels, lipid parameters', 'absolute levels of PCSK9 and LDL-C', 'LDL-C levels']","[{'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0044548', 'cui_str': '1-octacosanol'}, {'cui': 'C0065936', 'cui_str': 'menatetrenone'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0006856', 'cui_str': 'Cane'}]","[{'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C1174937', 'cui_str': 'PCSK9 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}]",87.0,0.0828584,The absolute levels of PCSK9 and LDL-C were not significantly different from baseline to 13 weeks.,"[{'ForeName': 'Milica Zrnic', 'Initials': 'MZ', 'LastName': 'Ciric', 'Affiliation': 'Department of Bromatology, Faculty of Pharmacy, University of Belgrade, Vojvode Stepe 450, 11221 Belgrade, Serbia.'}, {'ForeName': 'Miodrag', 'Initials': 'M', 'LastName': 'Ostojic', 'Affiliation': 'Faculty of Medicine, University of Belgrade, 6 Dr Subotica Street, 11000 Belgrade, Serbia.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Baralic', 'Affiliation': 'Department of Pharmacy, Zvezdara University Medical Center, Dimitrija Tucovića 161, 11000 Belgrade, Serbia.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Kotur-Stevuljevic', 'Affiliation': 'Department of Medical Biochemistry, Faculty of Pharmacy, University of Belgrade, Vojvode Stepe 450, 11221 Belgrade, Serbia.'}, {'ForeName': 'Brizita I', 'Initials': 'BI', 'LastName': 'Djordjevic', 'Affiliation': 'Department of Bromatology, Faculty of Pharmacy, University of Belgrade, Vojvode Stepe 450, 11221 Belgrade, Serbia.'}, {'ForeName': 'Stana', 'Initials': 'S', 'LastName': 'Markovic', 'Affiliation': 'Department of Pharmacy, Zvezdara University Medical Center, Dimitrija Tucovića 161, 11000 Belgrade, Serbia.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Zivkovic', 'Affiliation': 'Department of Pharmacy, Zvezdara University Medical Center, Dimitrija Tucovića 161, 11000 Belgrade, Serbia.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Stankovic', 'Affiliation': 'Department of Bromatology, Faculty of Pharmacy, University of Belgrade, Vojvode Stepe 450, 11221 Belgrade, Serbia.'}]",Nutrients,['10.3390/nu13030903'] 2828,33802181,Feasibility and Acceptability of a Healthy Nordic Diet Intervention for the Treatment of Depression: A Randomized Controlled Pilot Trial.,"Healthy diet interventions have been shown to improve depressive symptoms, but there is a need for randomized controlled trials (RCTs) that are double blind and investigate biological mechanisms. The primary objectives of this randomized controlled pilot trial were to test the palatability of the meals and the acceptability of the intervention in preparation for an 8-week RCT in the future, which will investigate whether a healthy Nordic diet improves depressive symptoms in individuals with major depressive disorder, and associated biological mechanisms. Depressed ( n = 10) and non-depressed ( n = 6) women and men were randomized to receive either a healthy Nordic diet (ND) or a control diet (CD) for 8 days. Participants were blinded to their diet allocation and the study hypotheses. Health questionnaires were completed before and after the intervention and, throughout the study, questionnaires assessed participants' liking for the meals, their sensory properties, adherence, and open-ended feedback. In the ND group, 75% of participants consumed only the provided foods, as instructed, compared to 50% of CD participants. The meals of both diets, on average, received good ratings for liking and sensory properties, though the ND ratings were somewhat higher. Overall, results were positive and informative, indicating that the planned RCT will be feasible and well-accepted, with some proposed modifications.",2021,"The meals of both diets, on average, received good ratings for liking and sensory properties, though the ND ratings were somewhat higher.","['Depressed ( n = 10) and non-depressed ( n = 6) women and men', 'Depression', 'individuals with major depressive disorder, and associated biological mechanisms']","['Healthy Nordic Diet Intervention', 'healthy Nordic diet (ND) or a control diet (CD', 'Healthy diet interventions', 'healthy Nordic diet']","['Health questionnaires', 'Feasibility and Acceptability', 'depressive symptoms']","[{'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",6.0,0.0909961,"The meals of both diets, on average, received good ratings for liking and sensory properties, though the ND ratings were somewhat higher.","[{'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Sabet', 'Affiliation': 'Faculty of Medicine and Health, School of Medical Sciences, Örebro University, Södra Grev Rosengatan 32, 70362 Örebro, Sweden.'}, {'ForeName': 'Moa S', 'Initials': 'MS', 'LastName': 'Ekman', 'Affiliation': 'Faculty of Medicine and Health, School of Medical Sciences, Örebro University, Södra Grev Rosengatan 32, 70362 Örebro, Sweden.'}, {'ForeName': 'A Sofia', 'Initials': 'AS', 'LastName': 'Lundvall', 'Affiliation': 'Faculty of Medicine and Health, School of Medical Sciences, Örebro University, Södra Grev Rosengatan 32, 70362 Örebro, Sweden.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Risérus', 'Affiliation': 'Department of Public Health and Caring Sciences, Clinical Nutrition and Metabolism, Uppsala University, 75122 Uppsala, Sweden.'}, {'ForeName': 'Ulrica', 'Initials': 'U', 'LastName': 'Johansson', 'Affiliation': 'Department of Clinical Sciences, Paediatrics, Umeå University, 90185 Umeå, Sweden.'}, {'ForeName': 'Åsa', 'Initials': 'Å', 'LastName': 'Öström', 'Affiliation': 'School of Hospitality, Culinary Arts and Meal Science, Örebro University, 71202 Grythyttan, Sweden.'}, {'ForeName': 'Viola', 'Initials': 'V', 'LastName': 'Adamsson', 'Affiliation': 'Department of Public Health and Caring Sciences, Clinical Nutrition and Metabolism, Uppsala University, 75122 Uppsala, Sweden.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Clinical Epidemiology and Biostatistics, School of Medical Sciences, Örebro University, 70182 Örebro, Sweden.'}, {'ForeName': 'Mussie', 'Initials': 'M', 'LastName': 'Msghina', 'Affiliation': 'Faculty of Medicine and Health, School of Medical Sciences, Örebro University, Södra Grev Rosengatan 32, 70362 Örebro, Sweden.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Brummer', 'Affiliation': 'Faculty of Medicine and Health, School of Medical Sciences, Örebro University, Södra Grev Rosengatan 32, 70362 Örebro, Sweden.'}]",Nutrients,['10.3390/nu13030902'] 2829,33802119,"Effects of a Lifestyle Intervention on Health-Promoting Behavior, Psychological Distress and Reproductive Health of Overweight and Obese Female College Students.","This study aimed to examine the effect of a lifestyle intervention (LSI) on overweight or obese female university students. Participants: A total of 53 overweight or obese female college students participated. This study was conducted from May to December 2017 in Jeonbuk Province, South Korea. A quasi-experimental design using a non-equivalent control group pretest-posttest was used. The LSI consisted of providing health information, individual health counseling, lifestyle monitoring, and effective support based on the interaction model of client health behavior, which was implemented for 12 weeks. Significant group differences were found in health-promoting behavior, psychological distress, reproductive health, body weight, body fat, and triglyceride level among participants. LSIs are effective in improving health-promoting behavior, psychological distress, reproductive health, and body composition. Therefore, healthcare providers should develop and apply LSIs through interaction for overweight or obese female college students.",2021,"Significant group differences were found in health-promoting behavior, psychological distress, reproductive health, body weight, body fat, and triglyceride level among participants.","['Participants', 'overweight or obese female college students', 'December 2017 in Jeonbuk Province, South Korea', '53 overweight or obese female college students participated', 'overweight or obese female university students', 'Overweight and Obese Female College Students']","['Lifestyle Intervention', 'lifestyle intervention (LSI']","['health-promoting behavior, psychological distress, reproductive health, body weight, body fat, and triglyceride level', 'Health-Promoting Behavior, Psychological Distress and Reproductive Health']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0517496', 'cui_str': 'Health promotion behavior'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}]",53.0,0.0171013,"Significant group differences were found in health-promoting behavior, psychological distress, reproductive health, body weight, body fat, and triglyceride level among participants.","[{'ForeName': 'Ju-Hee', 'Initials': 'JH', 'LastName': 'Nho', 'Affiliation': 'College of Nursing, Jeonbuk National University, Jeonju 54896, Korea.'}, {'ForeName': 'Soo-Wan', 'Initials': 'SW', 'LastName': 'Chae', 'Affiliation': 'Clinical Trial Center for Functional Foods, Jeonbuk National University Hospital, Jeonju 54907, Korea.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare9030309'] 2830,33801674,Dental Sealant Composition-Retention Assessment in Young Permanent Molars.,"Tooth decay in children and adolescents remains a public health problem, despite prophylaxis and preventive measures being largely available. The aim of our study was to evaluate the clinical behavior of four dental sealants, related to first permanent molar topography and patient age (when sealant was applied for the first time). We assessed, by means of visual inspection and palpation with a dental probe, a group of 200 children, enrolled corresponding to school age-grade (mean age of 7 years at baseline) and randomly divided according to the material used as dental sealant (Admira seal©, Embrace Wet Bond©, Fotoseal©, GC Fuji Triaje©) in 4 groups ( n = 50). Sealant clinical evaluation was made at 6-, 12-, 18-month intervals for dental material retention assessment. At 6 months, the sealant detached the most from 3.6 molars, and the material used was Fotoseal© (27.6%). At 12 months, Fotoseal© (48.3%) and GC Fuji Triaje© (41.4%) from 3.6 molars express detachment. At 18 months, 4.6. molars sealed with Admira Seal© (25.7%) and Embrace Wet Bond© (28.6%) lost the sealant. We noticed less detachment in maxillary molars and if sealant was applied around 7 years of age. In conclusion, sealant application on first permanent molars must be encouraged and practitioners can choose between various materials available.",2021,"At 12 months, Fotoseal© (48.3%) and GC Fuji Triaje© (41.4%) from 3.6 molars express detachment.","['200 children, enrolled corresponding to school age-grade (mean age of 7 years at baseline', 'children and adolescents', 'Young Permanent Molars']","['dental sealant (Admira seal©, Embrace Wet Bond']",['Embrace Wet Bond'],"[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0031992', 'cui_str': 'Pit Fissure Sealants'}, {'cui': 'C1313391', 'cui_str': 'admira'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}]","[{'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}]",200.0,0.0448759,"At 12 months, Fotoseal© (48.3%) and GC Fuji Triaje© (41.4%) from 3.6 molars express detachment.","[{'ForeName': 'Alexandrina', 'Initials': 'A', 'LastName': 'Muntean', 'Affiliation': 'Department of Paediatric Dentistry, Iuliu Hatieganu University of Medicine and Pharmacy, 31 A. Iancu Street, 400083 Cluj-Napoca, Romania.'}, {'ForeName': 'Codruta', 'Initials': 'C', 'LastName': 'Sarosi', 'Affiliation': 'Institute of Chemistry Raluca Ripan, Department of Polymer Composites, Babes-Bolyai University, 30 Fantanele Str., 400294 Cluj-Napoca, Romania.'}, {'ForeName': 'Sorina', 'Initials': 'S', 'LastName': 'Sava', 'Affiliation': 'Department of Prosthodontics and Dental Materials, Iuliu Hatieganu University of Medicine and Pharmacy, 15 V. Babes Street, 400012 Cluj-Napoca, Romania.'}, {'ForeName': 'Marioara', 'Initials': 'M', 'LastName': 'Moldovan', 'Affiliation': 'Institute of Chemistry Raluca Ripan, Department of Polymer Composites, Babes-Bolyai University, 30 Fantanele Str., 400294 Cluj-Napoca, Romania.'}, {'ForeName': 'Andrei Ilie', 'Initials': 'AI', 'LastName': 'Condurache', 'Affiliation': 'Resident Physician-Laboratory Medicine, Cluj County Clinical Hospital, 3-5 Clinicilor Street, 3-5, 400000 Cluj-Napoca, Romania.'}, {'ForeName': 'Ada Gabriela', 'Initials': 'AG', 'LastName': 'Delean', 'Affiliation': 'Department of Conservative Dentistry, Iuliu Hatieganu University of Medicine and Pharmacy, 33 Motilor Street, 400001 Cluj-Napoca, Romania.'}]","Materials (Basel, Switzerland)",['10.3390/ma14071646'] 2831,33801514,Disaster Prevention Education along with Weekly Exercise Improves Self-Efficacy in Community-Dwelling Japanese People-A Randomized Control Trial.,"Background and Objectives : Both disaster prevention and health promotion have become public health challenges in Japan. Maintaining physical fitness from the perspective of disaster prevention and maintaining physical fitness from the perspective of health are basically covering similar issues, they are seen as different from one another because of differences in administrative jurisdiction in Japan. In the case of disaster prevention education, physical fitness is not mentioned. In and outside Japan, partial integration of disaster prevention education and health education is required. This study compares and examines the effects of disaster prevention education and traditional exercise education, as well as exercise practice. A randomized controlled trial alongside an evacuation behavior model during the event of a disaster were used in this research. Materials and Methods : A total of 97 community-dwelling participants were randomly allocated to two groups, a disaster prevention education group (Group D) and a traditional exercise education group (Group E). Group D received disaster prevention education with weekly exercise. Group E received traditional exercise education with weekly exercise. After ten weeks of intervention, the total evacuation time of the disaster evacuation model course, physical fitness, self-efficacy (General Self-Efficacy Scale: GSES), and health-related quality of life (QOL) were compared between the two groups. Results : No differences were observed between the two groups regarding the changes in the parameters of total evacuation time, physical fitness, and health-related QOL. However, the changes in GSES scores were significantly higher in Group D (1.4 ± 3.9) than in Group E (-1.1 ± 7.5). Conclusions : Disaster prevention education with weekly exercise significantly increased participants' self-efficacy compared to traditional exercise education. The combination of disaster prevention education and exercise practice may have a positive effect not only on disaster prevention behavior but also on self-efficacy in health promotion. Disaster prevention education does not directly influence health promotion, but it may be a very effective method for indirectly promoting health.",2021,"No differences were observed between the two groups regarding the changes in the parameters of total evacuation time, physical fitness, and health-related QOL.","['Japan', '97 community-dwelling participants', 'Community-Dwelling Japanese People']","['disaster prevention education with weekly exercise', 'traditional exercise education with weekly exercise', 'disaster prevention education and traditional exercise education', 'Materials and Methods ', 'disaster prevention education group (Group D) and a traditional exercise education']","[""participants' self-efficacy"", 'total evacuation time, physical fitness, and health-related QOL', 'GSES scores', 'Self-Efficacy', 'total evacuation time of the disaster evacuation model course, physical fitness, self-efficacy (General Self-Efficacy Scale: GSES), and health-related quality of life (QOL']","[{'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0012618', 'cui_str': 'Disasters'}, {'cui': 'C1633748', 'cui_str': 'Prevention education'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0582396', 'cui_str': 'Exercise education'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441838', 'cui_str': 'Group D'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012618', 'cui_str': 'Disasters'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",97.0,0.0137085,"No differences were observed between the two groups regarding the changes in the parameters of total evacuation time, physical fitness, and health-related QOL.","[{'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Katayama', 'Affiliation': 'Faculty of Sociology, Shikoku Gakuin University, Zentsuji-shi, Kagawa 765-8505, Japan.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Hase', 'Affiliation': 'Department of Clinical Psychology, Faculty of Medicine, Kagawa University, Kita-gun, Kagawa 761-0701, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Miyatake', 'Affiliation': 'Department of Hygiene, Faculty of Medicine, Kagawa University, Kita-gun, Kagawa 761-0701, Japan.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina57030231'] 2832,33801501,The Effect of Nordic Walking Training with Poles with an Integrated Resistance Shock Absorber on the Body Balance of Women over the Age of 60.,"The aim of this study was to assess the changes in the balance of healthy, elderly women as a result of Nordic walking training using of two types of poles: classic poles, and poles with an integrated resistance shock absorber. Thirty-four women completed the experiment (Age = 66.8 ± 4.1 years). They were randomly assigned into the experimental group-training with poles with an integrated resistance shock absorber-EG ( n = 17), and the control active group-training with classic poles-CG ( n = 17). Body balance was measured with Romberg sharpened test and using the AccuGait ™ force platform before and after an intervention lasting for 8 weeks (2 training sessions × 75 min per week). In ANOVA analysis, the Romberg sharpened test showed a statistically significant effect of ""time"" (F = 18.62, p < 0.001, ɳ 2 = 0.37). No interaction effect or clear ""time"" effect was observed in the ANOVA analysis for the results of posturographic tests ( p > 0.05). The lack of pre-post differences in posturographic tests indicates that further research is necessary, where, e.g., there are extended intervention times and more difficult examination tasks are performed. In the case of the Romberg test, both groups improved their results, which may indicate an improvement in perception and processing of sensory information, regardless of the type of training applied.",2021,"No interaction effect or clear ""time"" effect was observed in the ANOVA analysis for the results of posturographic tests ( p > 0.05).","['Women over the Age of 60', 'healthy, elderly women', 'Thirty-four women completed the experiment (Age = 66.8 ± 4.1 years']","['experimental group-training with poles with an integrated resistance shock absorber-EG', 'Nordic walking training', 'control active group-training with classic poles-CG', 'Nordic Walking Training with Poles with an Integrated Resistance Shock Absorber']","['Body balance', 'time', 'clear ""time"" effect', 'perception and processing of sensory information']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4517844', 'cui_str': '66.8'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0337815', 'cui_str': 'Poles'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0179059', 'cui_str': 'Carbon dioxide absorber'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}]",34.0,0.00490125,"No interaction effect or clear ""time"" effect was observed in the ANOVA analysis for the results of posturographic tests ( p > 0.05).","[{'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Marciniak', 'Affiliation': 'Department of Physical Activity Sciences and Health Promotion, Poznań University of Physical Education, 61-871 Poznań, Poland.'}, {'ForeName': 'Janusz', 'Initials': 'J', 'LastName': 'Maciaszek', 'Affiliation': 'Department of Physical Activity Sciences and Health Promotion, Poznań University of Physical Education, 61-871 Poznań, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Cyma-Wejchenig', 'Affiliation': 'Department of Physical Activity Sciences and Health Promotion, Poznań University of Physical Education, 61-871 Poznań, Poland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Szeklicki', 'Affiliation': 'Department of Physical Activity Sciences and Health Promotion, Poznań University of Physical Education, 61-871 Poznań, Poland.'}, {'ForeName': 'Rafał', 'Initials': 'R', 'LastName': 'Stemplewski', 'Affiliation': 'Department of Physical Activity Sciences and Health Promotion, Poznań University of Physical Education, 61-871 Poznań, Poland.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare9030267'] 2833,33801389,Effects of COVID-19 Lockdown on Adherence to Individual Home- or Gym-Based Exercise Training among Women with Postmenopausal Osteoporosis.,"Adherence is important for an exercise program's efficacy. This study aims at investigating whether the COVID-19 lockdown had different consequences on the adherence to an exercise program specifically designed for women with postmenopausal osteoporosis when administered as individual home training (IHT) or gym group training (GGT). At the start of the lockdown, which imposed the temporary closure of any gym activities, GGT participants were invited to continue to exercise at home. IHT participants continued to exercise at home as usual. Adherence was recorded via logs and measured as the percentage of exercise sessions actually performed out of the total number of scheduled sessions in three 1-month periods: one before (PRE) and two after (M1 and M2) the beginning of lockdown. Before lockdown, IHT (66.8% ± 26.6) and GGT (76.3% ± 26.6) adherence were similar. During lockdown, IHT participation increased (M1: 81.5% ± 31.0; M2: 88.0% ± 28.3), while that of GGT showed no statistical differences (M1: 79.4% ± 34.2; M2: 80.6% ± 36.4). Exercise protocols based on supervised gym practice must consider the possibility of disruptive events, which could cause a sudden interruption of gym activity and include educational initiatives to instruct participants to exercise effectively and safely without a trainer's direct supervision.",2021,This study aims at investigating whether the COVID-19 lockdown had different consequences on the adherence to an exercise program specifically designed for women with postmenopausal osteoporosis when administered as individual home training (IHT) or gym group training (GGT).,"['women with postmenopausal osteoporosis', 'Women with Postmenopausal Osteoporosis']","['COVID-19 Lockdown', 'COVID-19 lockdown', 'Individual Home- or Gym-Based Exercise Training', 'individual home training (IHT) or gym group training (GGT']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029458', 'cui_str': 'Postmenopausal osteoporosis'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],,0.00799652,This study aims at investigating whether the COVID-19 lockdown had different consequences on the adherence to an exercise program specifically designed for women with postmenopausal osteoporosis when administered as individual home training (IHT) or gym group training (GGT).,"[{'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Pinelli', 'Affiliation': ""Department for Life Quality Studies, Campus of Rimini, University of Bologna, Corso d'Augusto 237, 47921 Rimini, Italy.""}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Barone', 'Affiliation': ""Department for Life Quality Studies, Campus of Rimini, University of Bologna, Corso d'Augusto 237, 47921 Rimini, Italy.""}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Marini', 'Affiliation': ""Department for Life Quality Studies, Campus of Rimini, University of Bologna, Corso d'Augusto 237, 47921 Rimini, Italy.""}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Benvenuti', 'Affiliation': ""Department for Life Quality Studies, Campus of Rimini, University of Bologna, Corso d'Augusto 237, 47921 Rimini, Italy.""}, {'ForeName': 'Marie H', 'Initials': 'MH', 'LastName': 'Murphy', 'Affiliation': 'Centre for Exercise Medicine Physical Activity and Health, Ulster University, Newtownabbey, Co Antrim BT37 0QB, UK.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Julin', 'Affiliation': 'Department of Physiotherapy, Laurea University of Applied Sciences, 02650 Espoo, Finland.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Kemmler', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander-University Erlangen-Nürnberg, 91052 Erlangen, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Von Stengel', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander-University Erlangen-Nürnberg, 91052 Erlangen, Germany.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Di Paolo', 'Affiliation': ""Department for Life Quality Studies, Campus of Rimini, University of Bologna, Corso d'Augusto 237, 47921 Rimini, Italy.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dallolio', 'Affiliation': 'Department of Biomedical and Neuromotor Science, University of Bologna, Via San Giacomo 12, 40126 Bologna, Italy.'}, {'ForeName': 'Pasqualino', 'Initials': 'P', 'LastName': 'Maietta Latessa', 'Affiliation': ""Department for Life Quality Studies, Campus of Rimini, University of Bologna, Corso d'Augusto 237, 47921 Rimini, Italy.""}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Zinno', 'Affiliation': ""Department for Life Quality Studies, Campus of Rimini, University of Bologna, Corso d'Augusto 237, 47921 Rimini, Italy.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bragonzoni', 'Affiliation': ""Department for Life Quality Studies, Campus of Rimini, University of Bologna, Corso d'Augusto 237, 47921 Rimini, Italy.""}]",International journal of environmental research and public health,['10.3390/ijerph18052441'] 2834,33800841,Ten-Year Follow-Up of Patients Treated with Fecal Microbiota Transplantation for Recurrent Clostridioides difficile Infection from a Randomized Controlled Trial and Review of the Literature.,"Fecal microbiota transplantation (FMT) has become a well-established treatment for recurrent Clostridioides difficile infection (rCDI). While short-term outcomes and adverse events relating to FMT have been well documented, there still is a paucity of data with regard to long-term safety. In this report, we describe the long-term follow-up of the prospective cohort of the first randomized controlled trial of FMT for rCDI, and review the existing literature. A total of 34 patients were treated with FMT for rCDI. Seven patients were still alive after a follow-up of more than 10 years and three patients were lost to follow-up. None of the 34 patients had experienced a new-onset autoimmune, gastrointestinal, or malignant disorder during follow-up. We did not find any deterioration or amelioration of pre-existing medical conditions. Furthermore, no deaths directly attributable to FMT could be identified. These findings are in accordance with the data in available literature. In conclusion, no long-term adverse events or complications directly attributable to FMT were found in our prospective cohort. Review of the available literature does not point to long-term risks associated with FMT in this elderly population, provided that carefully screened fecal suspensions are being used. No firm conclusion on the long-term safety of FMT in younger patients could be drawn.",2021,"None of the 34 patients had experienced a new-onset autoimmune, gastrointestinal, or malignant disorder during follow-up.","['34 patients had experienced a new-onset autoimmune, gastrointestinal, or malignant disorder during follow-up', '34 patients were treated with']","['Fecal Microbiota Transplantation', 'FMT', 'Fecal microbiota transplantation (FMT']",[],"[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0443146', 'cui_str': 'Autoimmune reaction'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}]",[],34.0,0.0537494,"None of the 34 patients had experienced a new-onset autoimmune, gastrointestinal, or malignant disorder during follow-up.","[{'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'Ooijevaar', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, VU University Medical Center, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'van Nood', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, Erasmus Medical Center, Doctor Molewaterplein 40, 3015 GD Rotterdam, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Goorhuis', 'Affiliation': 'Department of Infectious Diseases, Amsterdam University Medical Centers, Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Terveer', 'Affiliation': 'Department of Medical Microbiology, Leiden University Medical Center, Albinusdreef 3, 2333 AZ Leiden, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van Prehn', 'Affiliation': 'Department of Medical Microbiology, Leiden University Medical Center, Albinusdreef 3, 2333 AZ Leiden, The Netherlands.'}, {'ForeName': 'H W', 'Initials': 'HW', 'LastName': 'Verspaget', 'Affiliation': 'Biobank LUMC, Leiden University Medical Center, Albinusdreef 3, 2333 AZ Leiden, The Netherlands.'}, {'ForeName': 'Y H', 'Initials': 'YH', 'LastName': 'van Beurden', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, VU University Medical Center, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands.'}, {'ForeName': 'M G W', 'Initials': 'MGW', 'LastName': 'Dijkgraaf', 'Affiliation': 'Department of Epidemiology and Data Science, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam Public Health, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Keller', 'Affiliation': 'Department of Gastroenterology and Hepatology, Leiden University Medical Center, Albinusdreef 3, 2333 AZ Leiden, The Netherlands.'}]",Microorganisms,['10.3390/microorganisms9030548'] 2835,33800281,A Canadian Prospective Study of Linkage of Randomized Clinical Trial to Cancer and Mortality Registry Data.,"In a prospective study, we sought to determine acceptability of linkage of administrative and clinical trial data among Canadian patients and Research Ethics Boards (REBs). The goal is to develop a more harmonized approach to data, with potential to improve clinical trial conduct through enhanced data quality collected at reduced cost and inconvenience for patients. On completion of the original LY.12 randomized clinical trial in lymphoma (NCT00078949), participants were invited to enrol in the Long-term Innovative Follow-up Extension (LIFE) component. Those consenting to do so provided comprehensive identifying information to facilitate linkage with their administrative data. We prospectively designed a global assessment of this innovative approach to clinical trial follow-up including rates of REB approval and patient consent. The pre-specified benchmark for patient acceptability was 80%. Of 16 REBs who reviewed the research protocol, 14 (89%) provided approval; two in Quebec declined due to small patient numbers. Of 140 patients invited to participate, 115 (82%, 95% CI 76 to 88%) from across 9 Canadian provinces provided consent and their full name, date of birth, health insurance number and postal code to facilitate linkage with their administrative data for long-term follow-up. Linkage of clinical trial and administrative data is feasible and acceptable. Further collaborative work including many stakeholders is required to develop an optimized secure approach to research. A more coordinated national approach to health data could facilitate more rapid testing and identification of new effective treatments across multiple jurisdictions and diseases from diabetes to COVID-19.",2021,A more coordinated national approach to health data could facilitate more rapid testing and identification of new effective treatments across multiple jurisdictions and diseases from diabetes to COVID-19.,"['Canadian patients and Research Ethics Boards (REBs', '140 patients invited to participate, 115 (82%, 95% CI 76 to 88%) from across 9 Canadian provinces provided consent and their full name, date of birth, health insurance number and postal code to facilitate linkage with their administrative data for long-term follow-up']",[],[],"[{'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0814851', 'cui_str': 'Research Ethics'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0421451', 'cui_str': 'Date of birth'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",[],[],140.0,0.300696,A more coordinated national approach to health data could facilitate more rapid testing and identification of new effective treatments across multiple jurisdictions and diseases from diabetes to COVID-19.,"[{'ForeName': 'Annette E', 'Initials': 'AE', 'LastName': 'Hay', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, ON K7L 2V6, Canada.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Mittmann', 'Affiliation': 'Sunnybrook Health Sciences Centre, Sunnybrook Research Institute, University of Toronto, Toronto, ON M4N 3M5, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Crump', 'Affiliation': 'Princess Margaret Cancer Centre, University of Toronto, Toronto, ON M5G 2C1, Canada.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Cheung', 'Affiliation': 'Sunnybrook Health Sciences Centre, Sunnybrook Research Institute, University of Toronto, Toronto, ON M4N 3M5, Canada.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Sleeth', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, ON K7L 3N6, Canada.""}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Needham', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, ON K7L 3N6, Canada.""}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Broekhoven', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, ON K7L 3N6, Canada.""}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Djurfeldt', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, ON K7L 3N6, Canada.""}, {'ForeName': 'Lois E', 'Initials': 'LE', 'LastName': 'Shepherd', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, ON K7L 3N6, Canada.""}, {'ForeName': 'Ralph M', 'Initials': 'RM', 'LastName': 'Meyer', 'Affiliation': 'Juravinski Cancer Centre/Hamilton Health Sciences, McMaster University, Hamilton, ON L8V 5C2, Canada.'}, {'ForeName': 'Bingshu E', 'Initials': 'BE', 'LastName': 'Chen', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, ON K7L 3N6, Canada.""}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Pater', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, ON K7L 3N6, Canada.""}]","Current oncology (Toronto, Ont.)",['10.3390/curroncol28020111'] 2836,33800054,The Effect of Electrical Muscle Stimulation on Muscle Mass and Balance in Older Adults with Dementia.,"BACKGROUND Electrical muscle stimulation (EMS) is effective for increasing physical function. However, there is no evidence regarding the effects of EMS on muscle mass and physical function in older adults with dementia. The aim of the present study was to quantify the effects of EMS on muscle mass and balance in older adults with dementia. METHODS A total of 32 participants were randomly assigned to an intervention group ( n = 16, age = 89.4 ± 4.8 years) and a control group ( n = 16, age = 88.1 ± 5.2 years). Participants in the intervention group underwent a general rehabilitation program (20 min for three days/week) and an EMS intervention (23 min for three days/week) for 23 weeks. Participants in the control group underwent general rehabilitation only. The efficacy of EMS was evaluated by lower limb muscle mass, the Berg Balance Scale (BBS), and the functional independence measure (FIM). RESULTS Muscle mass was significantly increased in the intervention group after 12 weeks ( p = 0.008), but average muscle mass in the control group did not change ( p = 0.18). Participants in the control group showed a significant decrease in BBS after 12 weeks ( p = 0.007), unlike those in the intervention group. Furthermore, there was a strong correlation between the mini-mental state examination (MMSE) results and the change in muscle mass, the BBS, and the FIM in the control group ( p < 0.05). CONCLUSIONS These findings suggest that EMS is a useful intervention for increasing muscle mass and maintaining balance function in older adults with dementia.",2021,"Participants in the control group showed a significant decrease in BBS after 12 weeks ( p = 0.007), unlike those in the intervention group.","['A total of 32 participants were randomly assigned to an intervention group ( n = 16, age = 89.4 ± 4.8 years) and a control group ( n = 16, age = 88.1 ± 5.2 years', 'Older Adults with Dementia', 'older adults with dementia']","['EMS intervention', 'general rehabilitation program', 'Electrical muscle stimulation (EMS', 'general rehabilitation only', 'Electrical Muscle Stimulation', 'EMS']","['lower limb muscle mass, the Berg Balance Scale (BBS), and the functional independence measure (FIM', 'BBS', 'average muscle mass', 'Muscle mass', 'Muscle Mass and Balance']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517765', 'cui_str': '4.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517790', 'cui_str': '5.2'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",32.0,0.0160433,"Participants in the control group showed a significant decrease in BBS after 12 weeks ( p = 0.007), unlike those in the intervention group.","[{'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Nishikawa', 'Affiliation': 'Faculty of Frontier Engineering, Institute of Science & Engineering, Kanazawa University, Kanazawa 920-1192, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Department of Rehabilitation, Faculty of Rehabilitation, Hiroshima International University, Hiroshima 739-2695, Japan.'}, {'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Kawade', 'Affiliation': 'MTG Co., Ltd., Nagoya 453-0041, Japan.'}, {'ForeName': 'Noriaki', 'Initials': 'N', 'LastName': 'Maeda', 'Affiliation': 'Division of Sports Rehabilitation, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima 734-8551, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Maruyama', 'Affiliation': 'Department of Clinical Neuroscience and Therapeutics, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima 734-8551, Japan.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Hyngstrom', 'Affiliation': 'Department of Physical Therapy, Marquette University, Milwaukee, WI 53201, USA.'}]",Brain sciences,['10.3390/brainsci11030339'] 2837,33810478,Implementation Factors for the Delivery of Alcohol and Drug Interventions to Children in Care: Qualitative Findings from the SOLID Feasibility Trial.,"Young people in care have a four-fold increased risk of drug and alcohol use compared to their peers. The SOLID study aimed to deliver two behaviour change interventions to reduce risky substance use (illicit drugs and alcohol) and improve mental health in young people in care. The study was carried out in 6 local authorities in the North East of England. Young people in care aged 12-20 years, who self-reported substance use within the previous 12 months were randomised to Motivational Enhancement Therapy, Social Behaviour and Network Therapy or control. In-depth 1:1 interviews and focus groups were used with young people in care, foster carers, residential workers, social workers and drug and alcohol practitioners to explore the key lessons from implementing the interventions. The Consolidated Framework of Implementation Research framed the analysis. Findings illustrated that the everyday interaction between individuals, service level dynamics and external policy related factors influenced the implementation of these new interventions at scale. We concluded that unless interventions are delivered in a way that can accommodate the often-complex lives of young people in care and align with the drug and alcohol practitioners' and social workers priorities, it is unlikely to be successfully implemented and become part of routine practice.",2021,Young people in care have a four-fold increased risk of drug and alcohol use compared to their peers.,"['young people in care, foster carers, residential workers, social workers and drug and alcohol practitioners', '6 local authorities in the North East of England', 'Children in Care', 'young people in care', 'Young people in care aged 12-20 years, who self-reported substance use within the previous 12 months']","['Motivational Enhancement Therapy, Social Behaviour and Network Therapy or control', 'risky substance use (illicit drugs and alcohol']","['risk of drug and alcohol use', 'mental health']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0580931', 'cui_str': 'In care'}, {'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0037444', 'cui_str': 'Social worker'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0728735', 'cui_str': 'Child in care'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0037397', 'cui_str': 'Social behavior'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0086190', 'cui_str': 'Drugs, Illegal'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",,0.00849295,Young people in care have a four-fold increased risk of drug and alcohol use compared to their peers.,"[{'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Alderson', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle NE2 4AX, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'McGovern', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle NE2 4AX, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Copello', 'Affiliation': 'School of Psychology, The University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'McColl', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle NE2 4AX, UK.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Kaner', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle NE2 4AX, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Smart', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle NE2 4AX, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McArdle', 'Affiliation': 'CAMHS, Northgate Hospital, Morpeth, Northumberland NE61 3BP, UK.'}, {'ForeName': 'Raghu', 'Initials': 'R', 'LastName': 'Lingam', 'Affiliation': ""Population Child Health Research Group, School of Women and Children's Health, Faculty of Medicine, University New South Wales, The Bright Alliance, High St & Avoca Street, Randwick, NSW 2031, Australia.""}]",International journal of environmental research and public health,['10.3390/ijerph18073461'] 2838,33810470,Different Doses of Carbohydrate Mouth Rinse Have No Effect on Exercise Performance in Resistance Trained Women.,"Carbohydrate (CHO) mouth rinse has been shown to enhance aerobic endurance performance. However, the effects of CHO mouth rinse on muscular strength and endurance are mixed and may be dependent on dosage of CHO. The primary purpose was to examine the effects of different dosages of CHO rinse on strength (bench press 1 repetition maximum [1-RM]) and muscular endurance (40% of 1-RM repetitions to failure) in female athletes. Sixteen resistance-trained females (age: 20 ± 1 years; height: 167 ± 3 cm; body mass: 67 ± 4 kg; BMI: 17 ± 2 kg/m 2 ; resistance training experience: 2 ± 1 years) completed four conditions in random order. The four conditions consisted of a mouth rinse with 25 mL solutions containing either 6% of CHO (Low dose of CHO: LCHO), 12% CHO (Moderate dose of CHO: MCHO), 18% CHO (High dose of CHO: HCHO) or water (Placebo: PLA) for 10 s prior to a bench press strength and muscular endurance test. Maximal strength (1-RM), muscular endurance (reps and total volume), heart rate (HR), ratings of perceived exertion (RPE) and glucose (GLU) were recorded each condition. There were no significant differences in strength ( p = 0.95) or muscular endurance (total repetitions: p = 0.06; total volume: p = 0.20) between conditions. Similarly, HR ( p = 0.69), RPE ( p = 0.09) and GLU ( p = 0.92) did not differ between conditions. In conclusion, various doses of CHO mouth rinse (6%, 12% and 18%) have no effect on upper body muscular strength or muscular endurance in female athletes.",2021,There were no significant differences in strength ( p = 0.95) or muscular endurance (total repetitions: p = 0.06; total volume: p = 0.20) between conditions.,"['female athletes', 'Resistance Trained Women', 'Sixteen resistance-trained females (age: 20 ± 1 years; height: 167 ± 3 cm; body mass: 67 ± 4 kg; BMI: 17 ± 2 kg/m 2 ; resistance training experience: 2 ± 1 years) completed four conditions in random order']","['CHO rinse', 'CHO (Low dose of CHO: LCHO', 'Placebo: PLA', 'muscular endurance (40% of 1-RM repetitions', 'Carbohydrate Mouth Rinse', 'CHO (Moderate dose of CHO: MCHO', 'CHO (High dose of CHO: HCHO) or water', 'CHO mouth rinse', 'Carbohydrate (CHO) mouth rinse']","['Maximal strength (1-RM), muscular endurance (reps and total volume), heart rate (HR), ratings of perceived exertion (RPE) and glucose (GLU', 'Exercise Performance', 'muscular strength and endurance', 'aerobic endurance performance', 'RPE', 'muscular endurance', 'upper body muscular strength or muscular endurance', 'GLU', 'strength']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4284072', 'cui_str': 'Order document'}]","[{'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1268087', 'cui_str': 'Upper body structure'}]",,0.0561929,There were no significant differences in strength ( p = 0.95) or muscular endurance (total repetitions: p = 0.06; total volume: p = 0.20) between conditions.,"[{'ForeName': 'Raci', 'Initials': 'R', 'LastName': 'Karayigit', 'Affiliation': 'Faculty of Sport Sciences, Ankara University, Gölbaşı, Ankara 06830, Turkey.'}, {'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Forbes', 'Affiliation': 'Department of Physical Education Studies, Brandon University, Brandon, MB R7A 6A9, Canada.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Naderi', 'Affiliation': 'Department of Sport Physiology, Boroujerd Branch, Islamic Azad University, Boroujerd 6915136111, Iran.'}, {'ForeName': 'Darren G', 'Initials': 'DG', 'LastName': 'Candow', 'Affiliation': 'Faculty of Kinesiology and Health Studies, University of Regina, Regina, SK S4S 0A2, Canada.'}, {'ForeName': 'Ulas C', 'Initials': 'UC', 'LastName': 'Yildirim', 'Affiliation': 'Faculty of Sport Sciences, Ankara University, Gölbaşı, Ankara 06830, Turkey.'}, {'ForeName': 'Firat', 'Initials': 'F', 'LastName': 'Akca', 'Affiliation': 'Faculty of Sport Sciences, Ankara University, Gölbaşı, Ankara 06830, Turkey.'}, {'ForeName': 'Dicle', 'Initials': 'D', 'LastName': 'Aras', 'Affiliation': 'Faculty of Sport Sciences, Ankara University, Gölbaşı, Ankara 06830, Turkey.'}, {'ForeName': 'Burak', 'Initials': 'B', 'LastName': 'C Yasli', 'Affiliation': 'Department of Physical Education and Sports, Igdir University, Iğdır 76000, Turkey.'}, {'ForeName': 'Aysegul', 'Initials': 'A', 'LastName': 'Sisman', 'Affiliation': 'Faculty of Sport Science, Muğla Sıtkı Koçman University, Muğla 48000, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Mor', 'Affiliation': 'Faculty of Sport Sciences, Sinop University, Sinop 57000, Turkey.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Kaviani', 'Affiliation': 'School of Nutrition and Dietetics, Faculty of Pure & Applied Science, Acadia University, Wolfville, NS B4P 2R6, Canada.'}]",International journal of environmental research and public health,['10.3390/ijerph18073463'] 2839,33809740,Distance Motor Learning during the COVID-19 Induced Confinement: Video Feedback with a Pedagogical Activity Improves the Snatch Technique in Young Athletes.,"The purpose of the present study was to investigate which of two strategies, Video Feedback with Pedagogical Activity (VF-PA) or Video Feedback (VF), would be more beneficial for the remote error correction of the snatch weightlifting technique during the confinement period. Thirty-five school aged children with at least three months of weightlifting experience were randomized to one of three training conditions: VF-PA, VF or the Control group (CONT). Subjects underwent test sessions one week before (T0) and one day after (T1) a six-session training period and a retention test session a week later (T2). During each test session, the Kinovea version 0.8.15 software measured the kinematic parameters of the snatch performance. Following distance learning sessions (T1), the VF-PA improved various kinematic parameters (i.e., barbell horizontal displacements, maximum height, looping and symmetry) compared with T0 ( p < 0.5; Cohen's d = 0.58-1.1). Most of these improvements were maintained during the retention test (T2) ( p <0.01, Cohen's d = 1.2-1.3) when compared withT0. However, the VF group improved only twoparameters (i.e., barbell symmetry and horizontal displacement) at T1 ( p < 0.05; Cohen's d = 0.9), which were not maintained at T2. Better horizontal displacement and looping values were registered during the retention test in the VF-PA group compared with theCONT group ( p < 0.05, Cohen's d = 1.49-1.52). The present findings suggest combining video feedback with pedagogical activity during the pandemic induced online coaching or physical education to improve movement learning in school aged children.",2021,"Better horizontal displacement and looping values were registered during the retention test in the VF-PA group compared with theCONT group ( p < 0.05, Cohen's d = 1.49-1.52).","['Thirty-five school aged children with at least three months of weightlifting experience', 'school aged children', 'Young Athletes']","['Pedagogical Activity', 'pandemic induced online coaching or physical education', 'Video Feedback with Pedagogical Activity (VF-PA) or Video Feedback (VF', 'VF-PA, VF or the Control group (CONT']","['Distance Motor Learning', 'Better horizontal displacement and looping values']","[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",35.0,0.0157807,"Better horizontal displacement and looping values were registered during the retention test in the VF-PA group compared with theCONT group ( p < 0.05, Cohen's d = 1.49-1.52).","[{'ForeName': 'Mohamed Abdelkader', 'Initials': 'MA', 'LastName': 'Souissi', 'Affiliation': 'Research Unit, ""Physical Activity, Sport and Health"", UR18JS01, National Observatory of Sport, Tunis 1003, Tunisia.'}, {'ForeName': 'Achraf', 'Initials': 'A', 'LastName': 'Ammar', 'Affiliation': 'Institute of Sport Science, Otto-von-Guericke-University Magdeburg, 39106 Magdeburg, Germany.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Trabelsi', 'Affiliation': 'High Institute of Sport and Physical Education, Sfax University, Sfax 3000, Tunisia.'}, {'ForeName': 'Jordan M', 'Initials': 'JM', 'LastName': 'Glenn', 'Affiliation': 'Department of Health, Exercise Science Research Center Human Performance and Recreation, University of Arkansas, Fayetteville, AR 72701, USA.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Boukhris', 'Affiliation': 'Research Unit, ""Physical Activity, Sport and Health"", UR18JS01, National Observatory of Sport, Tunis 1003, Tunisia.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Trabelsi', 'Affiliation': 'High Institute of Sport and Physical Education, Sfax University, Sfax 3000, Tunisia.'}, {'ForeName': 'Bassem', 'Initials': 'B', 'LastName': 'Bouaziz', 'Affiliation': 'Multimedia Information Systems and Advanced Computing Laboratory (MIRACL), University of Sfax, Sfax 3021, Tunisia.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Zmijewski', 'Affiliation': 'Jozef Pilsudski University of Physical Education in Warsaw, 00-809 Warsaw, Poland.'}, {'ForeName': 'Hichem', 'Initials': 'H', 'LastName': 'Souissi', 'Affiliation': 'Research Unit, ""Physical Activity, Sport and Health"", UR18JS01, National Observatory of Sport, Tunis 1003, Tunisia.'}, {'ForeName': 'Anis Ben', 'Initials': 'AB', 'LastName': 'Chikha', 'Affiliation': 'Research Unit, ""Physical Activity, Sport and Health"", UR18JS01, National Observatory of Sport, Tunis 1003, Tunisia.'}, {'ForeName': 'Tarak', 'Initials': 'T', 'LastName': 'Driss', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical Activity, Health andLearning (LINP2), UFR STAPS, UPL, Paris Nanterre University, 92000 Nanterre, France.'}, {'ForeName': 'Hamdi', 'Initials': 'H', 'LastName': 'Chtourou', 'Affiliation': 'Research Unit, ""Physical Activity, Sport and Health"", UR18JS01, National Observatory of Sport, Tunis 1003, Tunisia.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Hoekelmann', 'Affiliation': 'Institute of Sport Science, Otto-von-Guericke-University Magdeburg, 39106 Magdeburg, Germany.'}, {'ForeName': 'Nizar', 'Initials': 'N', 'LastName': 'Souissi', 'Affiliation': 'Research Unit, ""Physical Activity, Sport and Health"", UR18JS01, National Observatory of Sport, Tunis 1003, Tunisia.'}]",International journal of environmental research and public health,['10.3390/ijerph18063069'] 2840,33808999,"Keeping Hope Possible Toolkit: The Development and Evaluation of a Psychosocial Intervention for Parents of Infants, Children and Adolescents with Life Limiting and Life Threatening Illnesses.","BACKGROUND Globally, many infants and children are diagnosed with illnesses that impose limitations on their well-being and life course trajectory. Children's care becomes the central focus of family life. Inadequate support for parents is detrimental to their well-being and management of their child's care and support needs. METHODS The second phase of this evaluation study followed a quasi-experimental crossover design to test a theory-based psychosocial intervention, the Keeping Hope Possible Toolkit. Fifty-nine participants were randomly assigned to one of two sequence groups, with measures of hope, feelings of control, distress, and uncertainty completed pre- and post-intervention, and at a three-month follow-up. Qualitative interviews sought to assess participant experiences with the intervention, along with acceptability and feasibility. RESULTS Significant influence on parental distress was found, and the qualitative findings reveal benefits of the intervention for parental wellbeing. The intervention effectively offered practical and emotional support to diverse family caregivers. CONCLUSIONS The evidence-informed KHP intervention can be used by healthcare providers to intervene with family caregivers to support their dynamic emotions including hope, need to live in the moment and remember self, and social preferences. In doing so, parents' critical caregiving activities can be sustained and their child's health and wellbeing optimized.",2021,"The evidence-informed KHP intervention can be used by healthcare providers to intervene with family caregivers to support their dynamic emotions including hope, need to live in the moment and remember self, and social preferences.","['Parents of Infants, Children and Adolescents with Life Limiting and Life Threatening Illnesses', 'Fifty-nine participants']","['Psychosocial Intervention', 'KHP intervention']",['parental distress'],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C3830128', 'cui_str': '59'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",59.0,0.0662837,"The evidence-informed KHP intervention can be used by healthcare providers to intervene with family caregivers to support their dynamic emotions including hope, need to live in the moment and remember self, and social preferences.","[{'ForeName': 'Jill M G', 'Initials': 'JMG', 'LastName': 'Bally', 'Affiliation': 'College of Nursing, University of Saskatchewan, Saskatoon, SK S7N 5E5, Canada.'}, {'ForeName': 'Meridith', 'Initials': 'M', 'LastName': 'Burles', 'Affiliation': 'College of Nursing, University of Saskatchewan, Saskatoon, SK S7N 5E5, Canada.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Spurr', 'Affiliation': 'College of Nursing, University of Saskatchewan, Saskatoon, SK S7N 5E5, Canada.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Holtslander', 'Affiliation': 'College of Nursing, University of Saskatchewan, Saskatoon, SK S7N 5E5, Canada.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Hodgson-Viden', 'Affiliation': 'College of Medicine, University of Saskatchewan, Saskatoon, SK S7N 5E5, Canada.'}, {'ForeName': 'Roona', 'Initials': 'R', 'LastName': 'Sinha', 'Affiliation': 'College of Medicine, University of Saskatchewan, Saskatoon, SK S7N 5E5, Canada.'}, {'ForeName': 'Marcelline', 'Initials': 'M', 'LastName': 'Zimmer', 'Affiliation': 'Ronald McDonald House Saskatchewan, Saskatoon, SK S7N 0K4, Canada.'}]","Children (Basel, Switzerland)",['10.3390/children8030218'] 2841,33808784,"Efficacy of a Low-Dose Diosmin Therapy on Improving Symptoms and Quality of Life in Patients with Chronic Venous Disease: Randomized, Double-Blind, Placebo-Controlled Trial.","Chronic Venous Disease (CVD) is a common medical condition affecting up to 80% of the general population. Clinical manifestations can range from mild to more severe signs and symptoms that contribute to the impairment of the quality of life (QoL) of affected patients. Among treatment options, venoactive drugs such as diosmin are widely used in the symptomatic treatment in all clinical stages. The aim of this study is to determine the effectiveness of a new formulated diosmin in relieving symptoms and improving QoL in patients suffering from CVD. In this randomized, double-blind, placebo-controlled, multicenter clinical study, CVD patients with a Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification system between C2 and C4 were randomized to receive a bioavailable diosmin (as μsmin ® Plus) 450 mg tablet once daily or a placebo for 8 weeks. Clinical symptoms and QoL were monitored using the measurement of leg circumference, visual analogue scale (VAS) for pain, Global Index Score (GIS) and Venous Clinical Severity Score (VCSS). A total of 72 subjects completed the study. From week 4, leg edema was significantly decreased in the active group ( p < 0.001). An improvement in the VAS score was observed in the active group compared to placebo at the end of treatment ( p < 0.05). GIS and VCSS scores were significantly improved in the active group at week 8 ( p < 0.001). No treatment related-side effects were recorded. The results of this study showed that the administration of low-dose μsmin ® Plus was safe and effective in relieving symptoms and improving QoL in subjects with CVD.",2021,GIS and VCSS scores were significantly improved in the active group at week 8 ( p < 0.001).,"['patients suffering from CVD', 'CVD patients with a Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification system between C2 and C4', 'Patients with Chronic Venous Disease', 'Chronic Venous Disease (CVD', '72 subjects completed the study', 'subjects with CVD']","['bioavailable diosmin', 'Placebo', 'placebo', 'Low-Dose Diosmin Therapy']","['leg edema', 'leg circumference, visual analogue scale (VAS) for pain, Global Index Score (GIS) and Venous Clinical Severity Score (VCSS', 'VAS score', 'safe and effective in relieving symptoms and improving QoL', 'relieving symptoms and improving QoL', 'Symptoms and Quality of Life', 'Clinical symptoms and QoL', 'GIS and VCSS scores', 'side effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0235522', 'cui_str': 'Disorder of vein'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0935763', 'cui_str': 'Bioavailable'}, {'cui': 'C0012498', 'cui_str': 'Diosmin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0235886', 'cui_str': 'Leg edema'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0815319', 'cui_str': 'Geographical Information Systems'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",72.0,0.165793,GIS and VCSS scores were significantly improved in the active group at week 8 ( p < 0.001).,"[{'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Serra', 'Affiliation': 'Interuniversity Center of Phlebolymphology (CIFL), International Research and Educational Program in Clinical and Experimental Biotechnology, University Magna Graecia of Catanzaro, Viale Europa, 88100 Catanzaro, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Ielapi', 'Affiliation': 'Interuniversity Center of Phlebolymphology (CIFL), International Research and Educational Program in Clinical and Experimental Biotechnology, University Magna Graecia of Catanzaro, Viale Europa, 88100 Catanzaro, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bitonti', 'Affiliation': 'Private Office, 80100 Rome, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Candido', 'Affiliation': 'Intensive Care Unit, Pugliese Ciaccio Hospital of Catanzaro, 88100 Catanzaro, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Fregola', 'Affiliation': 'Interuniversity Center of Phlebolymphology (CIFL), International Research and Educational Program in Clinical and Experimental Biotechnology, University Magna Graecia of Catanzaro, Viale Europa, 88100 Catanzaro, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Gallo', 'Affiliation': 'Interuniversity Center of Phlebolymphology (CIFL), International Research and Educational Program in Clinical and Experimental Biotechnology, University Magna Graecia of Catanzaro, Viale Europa, 88100 Catanzaro, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Loria', 'Affiliation': 'Thoracic Surgery Unit, Annunziata Hospital of Cosenza, 87100 Cosenza, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Muraca', 'Affiliation': 'Department of General Medicine, Health Agency of Catanzaro, 88100 Catanzaro, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Raimondo', 'Affiliation': 'Department Emergency, Pugliese Ciaccio Hospital of Catanzaro, 88100 Catanzaro, Italy.'}, {'ForeName': 'Luminița', 'Initials': 'L', 'LastName': 'Velcean', 'Affiliation': 'Fizio Center, 27, Ulpia Traiana St, 300211 Timișoara, Romania.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Guadagna', 'Affiliation': 'Opera CRO, a Tigermed Company 10 Cozia St., 300209 Timisoara, Romania.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Gallelli', 'Affiliation': 'Department of Health Sciences, University of Catanzaro, 88100 Catanzaro, Italy.'}]",Nutrients,['10.3390/nu13030999'] 2842,33808652,Effects of Combined Vitamin K2 and Vitamin D3 Supplementation on Na[ 18 F]F PET/MRI in Patients with Carotid Artery Disease: The INTRICATE Rationale and Trial Design.,"INTRICATE is a prospective double-blind placebo-controlled feasibility study, assessing the influence of combined vitamin K2 and vitamin D3 supplementation on micro-calcification in carotid artery disease as imaged by hybrid Sodium [ 18 F]Fluoride (Na[ 18 F]F) positron emission tomography (PET)/ magnetic resonance imaging (MRI). Arterial calcification is an actively regulated process and results from the imbalance between calcification promoting and inhibiting factors. Considering the recent advancements in medical imaging, ultrasound (US), PET/MRI, and computed tomography (CT) can be used for the selection and stratification of patients with atherosclerosis. Fifty-two subjects with asymptomatic carotid artery disease on at least one side of the neck will be included in the study. At baseline, an Na[ 18 F]F PET/MRI and CT examination will be performed. Afterwards, subjects will be randomized (1:1) to a vitamin K (400 µg MK-7/day) and vitamin D3 (80 µg/day) or to placebo. At the 3-month follow-up, subjects will undergo a second Na[ 18 F]F PET/MRI and CT scan. The primary endpoint is the change in Na[ 18 F]F PET/MRI (baseline vs. after 3 months) in the treatment group as compared to the placebo arm. Secondary endpoints are changes in plaque composition and in blood-biomarkers. The INTRICATE trial bears the potential to open novel avenues for future large scale randomized controlled trials to intervene in the plaque development and micro-calcification progression.",2021,The primary endpoint is the change in Na[ 18 F]F PET/MRI (baseline vs. after 3 months) in the treatment group as compared to the placebo arm.,"['patients with atherosclerosis', 'Patients with Carotid Artery Disease', 'Fifty-two subjects with asymptomatic carotid artery disease on at least one side of the neck will be included in the study']","['computed tomography (CT', 'hybrid Sodium [ 18 F]Fluoride (Na[ 18 F]F) positron emission tomography (PET)/ magnetic resonance imaging (MRI', 'Combined Vitamin K2 and Vitamin D3 Supplementation', 'placebo', 'vitamin K (400 µg MK-7/day) and vitamin D3', 'combined vitamin K2 and vitamin D3 supplementation']","['changes in plaque composition and in blood-biomarkers', 'change in Na[ 18 F]F PET/MRI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0007273', 'cui_str': 'Disorder of carotid artery'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0032744', 'cui_str': 'Positive beta particle'}, {'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0065936', 'cui_str': 'menatetrenone'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042878', 'cui_str': 'Vitamin K'}, {'cui': 'C3816746', 'cui_str': '400'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]",52.0,0.52667,The primary endpoint is the change in Na[ 18 F]F PET/MRI (baseline vs. after 3 months) in the treatment group as compared to the placebo arm.,"[{'ForeName': 'Alexandru', 'Initials': 'A', 'LastName': 'Florea', 'Affiliation': 'Department of Nuclear Medicine, University Hospital RWTH Aachen, 52074 Aachen, Germany.'}, {'ForeName': 'M Eline', 'Initials': 'ME', 'LastName': 'Kooi', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, 6229HX Maastricht, The Netherlands.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Mess', 'Affiliation': 'Department of Clinical Neurophysiology, Maastricht University Medical Center, 6229HX Maastricht, The Netherlands.'}, {'ForeName': 'Leon J', 'Initials': 'LJ', 'LastName': 'Schurgers', 'Affiliation': 'School for Cardiovascular Diseases (CARIM), Maastricht University, 6229HX Maastricht, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Bucerius', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, 6229HX Maastricht, The Netherlands.'}, {'ForeName': 'Felix M', 'Initials': 'FM', 'LastName': 'Mottaghy', 'Affiliation': 'Department of Nuclear Medicine, University Hospital RWTH Aachen, 52074 Aachen, Germany.'}]",Nutrients,['10.3390/nu13030994'] 2843,33808597,Impact of a Nutrition-Related Community Intervention on the Quantity and Quality of Children's School almuerzo .,"Foods and beverages that schoolchildren carry in their lunchboxes have high energy values but lack plain water, fresh fruits and vegetables. A nutrition-related community intervention on the quantity and quality of school almuerzo was performed, in which four primary schools participated, as part of two groups: 225 children in the intervention group (IG) and 177 children in the control group (CG). The parents from the IG had access to a website where they could consult information on eating habits and physical activity or school almuerzo menus. They were sent weekly text messages on their mobile phones and attended in-person sessions. Anthropometric measurements and surveys were performed in both groups at the start of the study, as well as after 6 and 12 months. The school almuerzo was assessed by recording foods that the children brought in their lunchboxes. At baseline, 88% of children brought a school almuerzo , 37% fruit, 17% vegetables, 40% plain water and 50% sweet drinks. In both groups, 50% of children brought a school almuerzo with an energy value above the recommended value (>340 kcal) during follow-up; however, the percentage of children who brought sweet drinks decreased ( p < 0.05), with sweet drinks contributing between 26% and 33% of the calories in the school almuerzo . In the IG, the quantity in milliliters of plain water increased at the end of the follow-up period ( p = 0.044). From the point of view of food-and-beverage quantity and quality, school almuerzo were unhealthy for both groups. The intervention failed to increase the frequency with which parents provided children with school almuerzo or enhance the quality of the latter.",2021,The intervention failed to increase the frequency with which parents provided children with school almuerzo or enhance the quality of the latter.,"['four primary schools participated, as part of two groups: 225 children in the intervention group (IG) and 177 children in the control group (CG', ""Children's School almuerzo ""]","['Nutrition-Related Community Intervention', 'nutrition-related community intervention']",['quantity in milliliters of plain water'],"[{'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0260267', 'cui_str': 'School child'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0439242', 'cui_str': 'mL'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]",,0.015486,The intervention failed to increase the frequency with which parents provided children with school almuerzo or enhance the quality of the latter.,"[{'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Vilchis-Gil', 'Affiliation': 'Epidemiological Research Unit in Endocrinology and Nutrition, Hospital Infantil de México Federico Gomez, Ministry of Health (SSA), 06720 Mexico City, Mexico.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Klünder-Klünder', 'Affiliation': ""Deputy Director of Research, Mexico Children's Hospital Federico Gómez, 06720 Mexico City, Mexico.""}, {'ForeName': 'Ximena', 'Initials': 'X', 'LastName': 'Duque', 'Affiliation': 'Infectious Diseases Research Unit, Pediatric Hospital, Mexican Institute of Social Security, 06600 Mexico City, Mexico.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Martínez-Andrade', 'Affiliation': 'Epidemiological and Health Services Research Unit, Mexican Institute of Social Security, 06600 Mexico City, Mexico.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Martínez-Almaráz', 'Affiliation': 'Epidemiological Research Unit in Endocrinology and Nutrition, Hospital Infantil de México Federico Gomez, Ministry of Health (SSA), 06720 Mexico City, Mexico.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Beristain-Lujano', 'Affiliation': 'Epidemiological Research Unit in Endocrinology and Nutrition, Hospital Infantil de México Federico Gomez, Ministry of Health (SSA), 06720 Mexico City, Mexico.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Flores-Huerta', 'Affiliation': 'Epidemiological Research Unit in Endocrinology and Nutrition, Hospital Infantil de México Federico Gomez, Ministry of Health (SSA), 06720 Mexico City, Mexico.'}]","Life (Basel, Switzerland)",['10.3390/life11030253'] 2844,33807745,The Effect of Protein Supplementation versus Carbohydrate Supplementation on Muscle Damage Markers and Soreness Following a 15-km Road Race: A Double-Blind Randomized Controlled Trial.,"We assessed whether a protein supplementation protocol could attenuate running-induced muscle soreness and other muscle damage markers compared to iso-caloric placebo supplementation. A double-blind randomized controlled trial was performed among 323 recreational runners (age 44 ± 11 years, 56% men) participating in a 15-km road race. Participants received milk protein or carbohydrate supplementation, for three consecutive days post-race. Habitual protein intake was assessed using 24 h recalls. Race characteristics were determined and muscle soreness was assessed with the Brief Pain Inventory at baseline and 1-3 days post-race. In a subgroup ( n = 149) muscle soreness was measured with a strain gauge algometer and creatine kinase (CK) and lactate dehydrogenase (LDH) concentrations were measured. At baseline, no group-differences were observed for habitual protein intake (protein group: 79.9 ± 26.5 g/d versus placebo group: 82.0 ± 26.8 g/d, p = 0.49) and muscle soreness (protein: 0.45 ± 1.08 versus placebo: 0.44 ± 1.14, p = 0.96). Subjects completed the race with a running speed of 12 ± 2 km/h. With the Intention-to-Treat analysis no between-group differences were observed in reported muscle soreness. With the per-protocol analysis, however, the protein group reported higher muscle soreness 24 h post-race compared to the placebo group (2.96 ± 2.27 versus 2.46 ± 2.38, p = 0.039) and a lower pressure muscle pain threshold in the protein group compared to the placebo group (71.8 ± 30.0 N versus 83.9 ± 27.9 N, p = 0.019). No differences were found in concentrations of CK and LDH post-race between groups. Post-exercise protein supplementation is not more preferable than carbohydrate supplementation to reduce muscle soreness or other damage markers in recreational athletes with mostly a sufficient baseline protein intake running a 15-km road race.",2021,Post-exercise protein supplementation is not more preferable than carbohydrate supplementation to reduce muscle soreness or other damage markers in recreational athletes with mostly a sufficient baseline protein intake running a 15-km road race.,"['323 recreational runners (age 44 ± 11 years, 56% men) participating in a 15-km road race', 'Following a 15-km Road Race']","['Post-exercise protein supplementation', 'Protein Supplementation versus Carbohydrate Supplementation', 'placebo', 'milk protein or carbohydrate supplementation', 'carbohydrate supplementation']","['concentrations of CK and LDH post-race', 'muscle soreness', 'strain gauge algometer and creatine kinase (CK) and lactate dehydrogenase (LDH) concentrations', 'Habitual protein intake', 'habitual protein intake', 'pressure muscle pain threshold', 'Brief Pain Inventory', 'Muscle Damage Markers and Soreness']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0556103', 'cui_str': 'Carbohydrate supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026138', 'cui_str': 'Milk protein'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0456564', 'cui_str': 'Gauges'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}]",323.0,0.674699,Post-exercise protein supplementation is not more preferable than carbohydrate supplementation to reduce muscle soreness or other damage markers in recreational athletes with mostly a sufficient baseline protein intake running a 15-km road race.,"[{'ForeName': 'Dominique S M', 'Initials': 'DSM', 'LastName': 'Ten Haaf', 'Affiliation': 'Department of Physiology, Radboud Institute for Health Sciences, Radboud University Medical Center, 6525 XZ Nijmegen, The Netherlands.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Flipsen', 'Affiliation': 'Department of Physiology, Radboud Institute for Health Sciences, Radboud University Medical Center, 6525 XZ Nijmegen, The Netherlands.'}, {'ForeName': 'Astrid M H', 'Initials': 'AMH', 'LastName': 'Horstman', 'Affiliation': 'FrieslandCampina, 3811 LP Amersfoort, The Netherlands.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Timmerman', 'Affiliation': 'Department of Anesthesiology, Pain and Palliative Medicine, Radboud University Medical Center, 6525 XZ Nijmegen, The Netherlands.'}, {'ForeName': 'Monique A H', 'Initials': 'MAH', 'LastName': 'Steegers', 'Affiliation': 'Department of Anesthesiology, Pain and Palliative Medicine, Radboud University Medical Center, 6525 XZ Nijmegen, The Netherlands.'}, {'ForeName': 'Lisette C P G M', 'Initials': 'LCPGM', 'LastName': 'de Groot', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, 6708 PB Wageningen, The Netherlands.'}, {'ForeName': 'Thijs M H', 'Initials': 'TMH', 'LastName': 'Eijsvogels', 'Affiliation': 'Department of Physiology, Radboud Institute for Health Sciences, Radboud University Medical Center, 6525 XZ Nijmegen, The Netherlands.'}, {'ForeName': 'Maria T E', 'Initials': 'MTE', 'LastName': 'Hopman', 'Affiliation': 'Department of Physiology, Radboud Institute for Health Sciences, Radboud University Medical Center, 6525 XZ Nijmegen, The Netherlands.'}]",Nutrients,['10.3390/nu13030858'] 2845,33807731,The Effect of Exogenous Beta-Hydroxybutyrate Salt Supplementation on Metrics of Safety and Health in Adolescents.,"The ketogenic diet is a high-fat, very low-carbohydrate, moderate-protein diet that will induce a state of ketosis, but because of its restrictive nature, it may be difficult to adhere to, especially in adolescents. Supplementing with exogenous beta-hydroxybutyrate salts may induce a state of temporary ketosis without any undesirable side effects, thereby promoting the benefits of ketosis and minimizing adherence requirements to a ketogenic diet. To date, beta-hydroxybutyrate supplementation in healthy adolescents has not been explored. Therefore, the purpose of this study was to examine the safety of exogenous beta-hydroxybutyrate salt supplementation in a healthy adolescent population. In the present study, 22 healthy male and female adolescents consumed 3.75 g of beta-hydroxybutyrate salts or maltodextrin placebo twice daily for 90 days. Comprehensive blood safety analysis, bone densitometry, happiness and emotional intelligence surveys, and blood pressure were assessed at Pre, Day 45, and Day 90. There were no significant differences detected in subjects supplementing with beta-hydroxybutyrate salts, indicating that exogenous beta-hydroxybutyrate salts had no detrimental impact on fasting blood safety metrics, bone density, happiness, emotional intelligence, or blood pressure. We conclude that supplementing with exogenous beta-hydroxybutyrate salts is safe and well-tolerated by healthy adolescents.",2021,"Supplementing with exogenous beta-hydroxybutyrate salts may induce a state of temporary ketosis without any undesirable side effects, thereby promoting the benefits of ketosis and minimizing adherence requirements to a ketogenic diet.","['Adolescents', 'healthy adolescent population', '22 healthy male and female adolescents consumed 3.75 g of', 'healthy adolescents']","['hydroxybutyrate supplementation', 'exogenous beta-hydroxybutyrate salts', 'Exogenous Beta-Hydroxybutyrate Salt Supplementation', 'beta-hydroxybutyrate salts or maltodextrin placebo', 'exogenous beta-hydroxybutyrate salt supplementation']","['fasting blood safety metrics, bone density, happiness, emotional intelligence, or blood pressure', 'Comprehensive blood safety analysis, bone densitometry, happiness and emotional intelligence surveys, and blood pressure', 'Metrics of Safety and Health']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0686747', 'cui_str': 'Well adolescent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C4517697', 'cui_str': '3.75'}]","[{'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0106006', 'cui_str': '3-hydroxybutyrate'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C2936496', 'cui_str': 'Blood Supply Safety'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C1510539', 'cui_str': 'Emotional Intelligence'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0920149', 'cui_str': 'Bone densitometry'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",22.0,0.0249799,"Supplementing with exogenous beta-hydroxybutyrate salts may induce a state of temporary ketosis without any undesirable side effects, thereby promoting the benefits of ketosis and minimizing adherence requirements to a ketogenic diet.","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Stefan', 'Affiliation': 'The Applied Science and Performance Institute, Research Division, Tampa, FL 33607, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Sharp', 'Affiliation': 'The Applied Science and Performance Institute, Research Division, Tampa, FL 33607, USA.'}, {'ForeName': 'Raad', 'Initials': 'R', 'LastName': 'Gheith', 'Affiliation': 'The Applied Science and Performance Institute, Research Division, Tampa, FL 33607, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Lowery', 'Affiliation': 'The Applied Science and Performance Institute, Research Division, Tampa, FL 33607, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Wilson', 'Affiliation': 'The Applied Science and Performance Institute, Research Division, Tampa, FL 33607, USA.'}]",Nutrients,['10.3390/nu13030854'] 2846,33807703,"Effects of a Rice-Based Diet in Korean Adolescents Who Habitually Skip Breakfast: A Randomized, Parallel Group Clinical Trial.","During adolescence, healthy eating habits are important, and regular meal intake has an especially positive effect on future health. However, the rate of skipping breakfast has gradually increased. Therefore, this study was conducted to evaluate the positive effects of a rice-based breakfast in Korean adolescents who usually skip breakfast. In this open parallel-group, randomized controlled trial, 105 middle and high school students aged 12-18 years who habitually skipped breakfast were recruited. They were randomly divided into three groups: the rice meal group (RMG, n = 35), wheat meal group (WMG, n = 35), and general meal group (GMG, n = 35). The RMG and WMG received a rice-based breakfast and wheat-based breakfast, respectively, for 12 weeks. After a 12-week intervention, the body fat mass ( p < 0.05) and body mass index ( p < 0.05) in the RMG were significantly lower than those in the other two groups, and the stress score was also significantly lower in the RMG ( p < 0.05). Moreover, after the intervention, in the RMG only, compared to baseline levels, the relative theta (RT) wave activity significantly decreased in eight electrode sites, and the relative alpha (RA) wave activity increased significantly. Eating a rice-based breakfast has positive effects on body fat accumulation and cognitive function in Korean adolescents. Furthermore, a rice-based breakfast plan that is preferred by adolescents should be developed to assist them in developing healthy eating habits.",2021,"After a 12-week intervention, the body fat mass ( p < 0.05) and body mass index ( p < 0.05) in the RMG were significantly lower than those in the other two groups, and the stress score was also significantly lower in the RMG (","['105 middle and high school students aged 12-18 years who habitually skipped breakfast were recruited', 'Korean adolescents who usually skip breakfast', 'Korean Adolescents', 'Korean adolescents', 'Who Habitually Skip Breakfast']","['rice meal group (RMG, n = 35), wheat meal group (WMG, n = 35), and general meal group (GMG', 'Rice-Based Diet', 'RMG ', 'rice-based breakfast']","['stress score', 'relative theta (RT) wave activity', 'body mass index', 'relative alpha (RA) wave activity', 'body fat mass', 'rate of skipping breakfast']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0560435', 'cui_str': 'Does skip'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0765796', 'cui_str': 'glucose-mannose-glucose'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0560435', 'cui_str': 'Does skip'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}]",105.0,0.0218082,"After a 12-week intervention, the body fat mass ( p < 0.05) and body mass index ( p < 0.05) in the RMG were significantly lower than those in the other two groups, and the stress score was also significantly lower in the RMG (","[{'ForeName': 'Hyun-Suk', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Food Science and Human Nutrition, Jeonbuk National University, 567 Baekje-daero, Deokjin-gu, Jeonju 54896, Korea.'}, {'ForeName': 'Su-Jin', 'Initials': 'SJ', 'LastName': 'Jung', 'Affiliation': 'Clinical Trial Center for Functional Foods, Jeonbuk National University Hospital, 20 Geonji-ro, Deokjin-gu, Jeonju 54907, Korea.'}, {'ForeName': 'Eun-Gyung', 'Initials': 'EG', 'LastName': 'Mun', 'Affiliation': 'Department of Food Science and Human Nutrition, Jeonbuk National University, 567 Baekje-daero, Deokjin-gu, Jeonju 54896, Korea.'}, {'ForeName': 'Myung-Sunny', 'Initials': 'MS', 'LastName': 'Kim', 'Affiliation': 'Research Group of Healthcare, Korea Food Research Institute, Wanju 55365, Korea.'}, {'ForeName': 'Soo-Muk', 'Initials': 'SM', 'LastName': 'Cho', 'Affiliation': 'Department of Agrofood Resources, National Institute of Agricultural Sciences, Rural Development Administration, Wanju 55365, Korea.'}, {'ForeName': 'Youn-Soo', 'Initials': 'YS', 'LastName': 'Cha', 'Affiliation': 'Department of Food Science and Human Nutrition, Jeonbuk National University, 567 Baekje-daero, Deokjin-gu, Jeonju 54896, Korea.'}]",Nutrients,['10.3390/nu13030853'] 2847,33807618,Resistant Starch Combined with Whey Protein Increases Postprandial Metabolism and Lowers Glucose and Insulin Responses in Healthy Adult Men.,"Resistant starch (RS) and/or protein consumption favorably influence energy metabolism, substrate utilization, and weight management. The current study administered four different versions of a pancake breakfast containing waxy maize or RS with and without whey protein (WP) and measured postprandial thermogenesis (TEM), fuel utilization, and circulating satiation and appetite factors for 180 min in a group of healthy, adult men. On four separate visits to the laboratory, eight participants were administered four different pancake breakfast meal challenges using a single-blind, randomized crossover design: (1) waxy maize starch (WMS) control; (2) WMS and WP (WMS + WP); (3) RS; or (4) RS and WP (RS + WP). TEM (kcals/180 min) was significantly greater ( p < 0.05) in RS + WP (45.11; confidence interval (CI), 33.81-56.41) compared to WMS (25.61; CI, 14.31-36.91), RS (29.44; CI, 18.14-40.74), and WMS + WP (24.64; CI, 13.34-35.94), respectively. Fat oxidation was enhanced ( p < 0.05) after RS + WP compared to RS at 60 min (+23.10%), WMS at 120 min (+27.49%), and WMS and WMS + WP at 180 min (+35.76%; +17.31%, respectively), and RER was decreased with RS + WP versus the other three meals (mean differences: ≥-0.021). Insulin concentrations were decreased ( p < 0.05) following RS + WP compared to WMS, whereas both RS (-46.19%) and RS + WP (-53.05%) insulin area under the curve (AUC) were greatly reduced ( p < 0.01) compared to WMS. While limited by sample size, meals containing both RS and WP increased postprandial thermogenesis and fat oxidation, and lowered insulin response compared to isocaloric meals without this combination. Therefore, RS + WP may favorably impact energy metabolism and thus weight control and body composition under chronic feeding conditions.",2021,"Insulin concentrations were decreased ( p < 0.05) following RS + WP compared to WMS, whereas both RS (-46.19%) and RS + WP (-53.05%) insulin area under the curve (AUC) were greatly reduced ( p < 0.01) compared to WMS.","['180 min in a group of healthy, adult men', 'Healthy Adult Men']","['Resistant Starch Combined with Whey Protein', 'waxy maize starch (WMS) control', 'Resistant starch (RS', 'pancake breakfast containing waxy maize or RS with and without whey protein (WP']","['energy metabolism, substrate utilization, and weight management', 'Fat oxidation', 'Insulin concentrations', 'postprandial thermogenesis and fat oxidation, and lowered insulin response', 'WMS', 'RER', 'Postprandial Metabolism and Lowers Glucose and Insulin Responses', '2) WMS and WP (WMS + WP); (3) RS; or (4) RS and WP (RS + WP', 'insulin area under the curve (AUC', 'postprandial thermogenesis (TEM), fuel utilization, and circulating satiation and appetite factors']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C1384515', 'cui_str': 'corn starch'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3853212', 'cui_str': 'Pancake'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0010028', 'cui_str': 'Zea mays'}]","[{'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0018841', 'cui_str': 'Heat Production'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1384515', 'cui_str': 'corn starch'}, {'cui': 'C0230779', 'cui_str': 'Granular endoplasmic reticulum'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}]",8.0,0.0527939,"Insulin concentrations were decreased ( p < 0.05) following RS + WP compared to WMS, whereas both RS (-46.19%) and RS + WP (-53.05%) insulin area under the curve (AUC) were greatly reduced ( p < 0.01) compared to WMS.","[{'ForeName': 'Alex E', 'Initials': 'AE', 'LastName': 'Mohr', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Minicucci', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Long', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Miller', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Keller', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Sheridan', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': ""O'brien"", 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Emery', 'Initials': 'E', 'LastName': 'Ward', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Schuler', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Connelly', 'Affiliation': 'Scott Connelly Foundation, Corona Del Mar, Newport Beach, CA 92625, USA.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, 1017 Copenhagen, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, 1017 Copenhagen, Denmark.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'He', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Gentile', 'Affiliation': 'Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO 80523, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Arciero', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}]","Foods (Basel, Switzerland)",['10.3390/foods10030537'] 2848,33807435,Effects of 4 Weeks of a Technique-Specific Protocol with High-Intensity Intervals on General and Specific Physical Fitness in Taekwondo Athletes: An Inter-Individual Analysis.,"The aim of this research was to compare the effects of a technique-specific high-intensity interval training (HIIT) protocol vs. traditional taekwondo training on physical fitness and body composition in taekwondo athletes, as well as to analyse the inter-individual response. Utilising a parallel controlled design, sixteen male and female athletes (five females and 11 males) were randomly divided into an experimental group (EG) that participated in the technique-specific HIIT and a control group (CG) that participated in traditional taekwondo training. Both groups trained three days/week for four weeks. Squat jump (SJ), countermovement jump (CMJ), 5-metre sprint (5M), 20-metre shuttle run (20MSR), taekwondo specific agility test (TSAT), multiple frequency speed of kick test (FSKT MULT ), total kicks, and kick decrement index (KDI), as well as body composition were evaluated. Results indicate that there are no significant differences ( p > 0.05) in the factors group and time factor and group by time interaction ( p > 0.05). Although percentage and effect size increases were documented for post-intervention fitness components in TSAT, total kicks, KDI, and 20MSR, responders and non-responders were also documented. In conclusion, a HIIT protocol based on taekwondo-specific technical movements does not report significant differences in fitness and body composition compared to traditional taekwondo training, nor inter-individual differences between athletes.",2021,"Although percentage and effect size increases were documented for post-intervention fitness components in TSAT, total kicks, KDI, and 20MSR, responders and non-responders were also documented.","['sixteen male and female athletes (five females and 11 males', 'Taekwondo Athletes']","['Technique-Specific Protocol with High-Intensity Intervals', 'technique-specific HIIT and a control group (CG) that participated in traditional taekwondo training', 'technique-specific high-intensity interval training (HIIT) protocol vs. traditional taekwondo training']","['General and Specific Physical Fitness', 'physical fitness and body composition', 'TSAT, total kicks, KDI, and 20MSR, responders and non-responders', 'Squat jump (SJ), countermovement jump (CMJ), 5-metre sprint (5M), 20-metre shuttle run (20MSR), taekwondo specific agility test (TSAT), multiple frequency speed of kick test (FSKT MULT ), total kicks, and kick decrement index (KDI), as well as body composition', 'fitness and body composition']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0475209', 'cui_str': 'meter'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]",16.0,0.00984554,"Although percentage and effect size increases were documented for post-intervention fitness components in TSAT, total kicks, KDI, and 20MSR, responders and non-responders were also documented.","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Ojeda-Aravena', 'Affiliation': 'Department of Physical Activity Sciences, Universidad de los Lagos (ULA), 5290000 Osorno, Chile.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Herrera-Valenzuela', 'Affiliation': 'School of Sport Sciences, Universidad Santo Tomás (UST), 8370003 Santiago, Chile.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Valdés-Badilla', 'Affiliation': 'Department of Physical Activity Sciences, Faculty of Education Sciences, Universidad Católica del Maule, 3530000 Talca, Chile.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Cancino-López', 'Affiliation': 'Exercise Science Laboratory, School of Kinesiology, Faculty of Medicine, Universidad Finis Terrae, 8370003 Santiago, Chile.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Zapata-Bastias', 'Affiliation': 'Sports Coach Career, School of Education, Universidad Viña del Mar, 2520000 Viña del Mar, Chile.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'García-García', 'Affiliation': 'Faculty of Sports Sciences, Universidad de Castilla-La Mancha (UCLM), 45071 Toledo, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph18073643'] 2849,33818472,Chloroquine nasal drops in asymptomatic & mild COVID-19: An exploratory randomized clinical trial.,"Background & objectives Chloroquine (CQN) administered as nasal drops has the potential to achieve much greater local tissue levels than with oral/systemic administration. This trial was undertaken to study the efficacy and safety profile of topical nasal administration of CQN drops in reducing viral load and preventing clinical progression in early COVID-19 infection. Methods This randomized clinical trial was done with a sample size of 60. Reverse transcription-polymerase chain reaction (RT-PCR) confirmed asymptomatic patients or those with mild COVID-19 illness [National Early Warning Score (NEWS) ≤4] were included. Patients were randomized in a 1:1 manner. Control arm (standard supportive treatment, n=30) was compared with intervention arm (n=30) of standard treatment plus CQN eye drops (0.03%) repurposed as nasal drops administered six times daily (0.5 ml/dose) for 10 days. Outcome measures were adverse events and adherence; clinical progression and outcomes were measured by NEWS; sequential RT-PCR cycle threshold (Ct) values were also noted on days 0, 3, 7 and 10. Results Nasal CQN was associated with local irritation in seven and non-compliance in one of 30 patients. Eleven patients were excluded due to enrolment error (2 - recovered; 9 - false-positive referral), and 49 patients were analyzed as per modified intention-to-treat analysis. Clinical recovery was noted as similar with 100 per cent asymptomatic by day seven in both arms. Virological outcomes also indicated similarly improving Ct values in both arms, and similar proportion of patients transitioning to non-infectivity by day 10 (controls - 19/25; nasal CQN - 15/24). Nine false-positive patients with enrolment error and day 0 RT-PCR negative were initially uninfected but had continuing COVID-19 exposure and treatment as per randomization. Patients receiving nasal CQN (n=5) demonstrated stable Ct values from day 0 to 10, while patients with no nasal CQN (n=4) demonstrated significant dip in Ct value indicating to infection (Ct<35) and infectivity (Ct<33). Interpretation & conclusions The present study suggests to the potential of topical nasal CQN in the prevention of COVID-19 infection if administered before the infection is established. No significant differences in clinical or virological outcome were however, demonstrated in patients with mild but established illness.",2021,"This trial was undertaken to study the efficacy and safety profile of topical nasal administration of CQN drops in reducing viral load and preventing clinical progression in early COVID-19 infection. ","['Eleven patients were excluded due to enrolment error (2 - recovered; 9 - false-positive referral), and 49 patients were analyzed as per modified intention-to-treat analysis', 'asymptomatic & mild COVID-19', 'Nine false-positive patients with enrolment error and day 0']","['Chloroquine (CQN', 'Chloroquine nasal drops', 'topical nasal CQN', 'nasal CQN', 'standard treatment plus CQN eye drops', 'CQN']","['local tissue levels', 'RT-PCR negative', 'clinical or virological outcome', 'Ct values', 'adverse events and adherence; clinical progression and outcomes were measured by NEWS; sequential RT-PCR cycle threshold (Ct) values', 'Ct value indicating to infection (Ct<35) and infectivity (Ct<33', 'stable Ct values', 'Clinical recovery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0991524', 'cui_str': 'Nasal drops'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0282425', 'cui_str': 'News'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0030657', 'cui_str': 'pathogenicity'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",11.0,0.278786,"This trial was undertaken to study the efficacy and safety profile of topical nasal administration of CQN drops in reducing viral load and preventing clinical progression in early COVID-19 infection. ","[{'ForeName': 'Alok', 'Initials': 'A', 'LastName': 'Thakar', 'Affiliation': 'Department of Otorhinolaryngology & Head & Neck Surgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Smriti', 'Initials': 'S', 'LastName': 'Panda', 'Affiliation': 'Department of Otorhinolaryngology & Head & Neck Surgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Pirabu', 'Initials': 'P', 'LastName': 'Sakthivel', 'Affiliation': 'Department of Otorhinolaryngology & Head & Neck Surgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Megha', 'Initials': 'M', 'LastName': 'Brijwal', 'Affiliation': 'Department of Microbiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Shivram', 'Initials': 'S', 'LastName': 'Dhakad', 'Affiliation': 'Department of Microbiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Avinash', 'Initials': 'A', 'LastName': 'Choudekar', 'Affiliation': 'Department of Microbiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Anupam', 'Initials': 'A', 'LastName': 'Kanodia', 'Affiliation': 'Department of Otorhinolaryngology & Head & Neck Surgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sushma', 'Initials': 'S', 'LastName': 'Bhatnagar', 'Affiliation': 'Department of Oncoanesthesia, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Anant', 'Initials': 'A', 'LastName': 'Mohan', 'Affiliation': 'Department of Pulmonary Medicine & Sleep Disorders, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Subir K', 'Initials': 'SK', 'LastName': 'Maulik', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Lalit', 'Initials': 'L', 'LastName': 'Dar', 'Affiliation': 'Department of Microbiology, All India Institute of Medical Sciences, New Delhi, India.'}]",The Indian journal of medical research,['10.4103/ijmr.IJMR_3665_20'] 2850,33823461,White Matter Hyperintensity and Cardiovascular Disease Outcomes in the SPRINT MIND Trial.,"BACKGROUND The Systolic Blood Pressure Intervention Trial (SPRINT) randomized patients to a goal systolic blood pressure (SBP) <120 mm Hg vs. <140 mm Hg. In a subset of participants, the SPRINT MIND ancillary study performed a baseline MRI and measured white matter hyperintensity volume (WMHv). In this secondary analysis, we evaluated the association between baseline WMHv and cardiovascular events during follow-up in the overall sample. METHODS The primary outcome was the same as SPRINT, a composite of stroke, myocardial infarction, acute coronary syndrome, decompensated congestive heart failure, or cardiovascular death. We fit Cox models to the primary outcome and report adjusted hazard ratios (HR) for log-transformed WMHv and quartiles of WMHv. RESULTS Among 717 participants, the median (IQR) baseline WMHv was 1.62 (0.66-3.98) mL. The primary outcome occurred in 51/719 (7.1%). The median WMHv was higher in patients with the primary outcome (3.40 mL versus 1.56 mL, p < 0.001). In adjusted models, WMHv as a log-transformed continuous variable was associated with the primary outcome (HR 1.44, 95% CI 1.15-1.80). The highest quartile of WMHv, compared to the lowest, was also independently associated with the primary outcome (HR 3.21, 95% CI 1.27-8.13). CONCLUSIONS We found that the baseline volume of WMH was associated with future CVD risk in SPRINT MIND. Prospective clinical trials with larger sample sizes than the current study are needed to determine whether intensive BP lowering can reduce the high cardiovascular risk in patients with WMH.",2021,"The primary outcome was the same as SPRINT, a composite of stroke, myocardial infarction, acute coronary syndrome, decompensated congestive heart failure, or cardiovascular death.","['patients with WMH', 'patients to a goal systolic blood pressure (SBP) <120\xa0mm Hg vs. <140\xa0mm Hg', '717 participants, the median (IQR) baseline WMHv was 1.62']",[],"['baseline MRI and measured white matter hyperintensity volume (WMHv', 'same as SPRINT, a composite of stroke, myocardial infarction, acute coronary syndrome, decompensated congestive heart failure, or cardiovascular death', 'median WMHv', 'adjusted hazard ratios (HR) for log-transformed WMHv and quartiles of WMHv', 'highest quartile of WMHv', 'baseline WMHv and cardiovascular events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",[],"[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1278655', 'cui_str': 'SAME AS'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",717.0,0.823306,"The primary outcome was the same as SPRINT, a composite of stroke, myocardial infarction, acute coronary syndrome, decompensated congestive heart failure, or cardiovascular death.","[{'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Sheibani', 'Affiliation': 'Departments of Neurology: University of Utah, MUSC, Johns Hopkins University, University of Chicago, MGH, 175 N. Medical Dr, Salt Lake City, UT 84132, USA.'}, {'ForeName': 'Ka-Ho', 'Initials': 'KH', 'LastName': 'Wong', 'Affiliation': 'Departments of Neurology: University of Utah, MUSC, Johns Hopkins University, University of Chicago, MGH, 175 N. Medical Dr, Salt Lake City, UT 84132, USA.'}, {'ForeName': 'Tanya N', 'Initials': 'TN', 'LastName': 'Turan', 'Affiliation': 'Departments of Neurology: University of Utah, MUSC, Johns Hopkins University, University of Chicago, MGH, 175 N. Medical Dr, Salt Lake City, UT 84132, USA.'}, {'ForeName': 'Sharon D', 'Initials': 'SD', 'LastName': 'Yeatts', 'Affiliation': 'Department of Public Health Sciences: MUSC, Salt Lake City, UT 84132, USA.'}, {'ForeName': 'Rebecca F', 'Initials': 'RF', 'LastName': 'Gottesman', 'Affiliation': 'Departments of Neurology: University of Utah, MUSC, Johns Hopkins University, University of Chicago, MGH, 175 N. Medical Dr, Salt Lake City, UT 84132, USA.'}, {'ForeName': 'Shyam', 'Initials': 'S', 'LastName': 'Prabhakaran', 'Affiliation': 'Departments of Neurology: University of Utah, MUSC, Johns Hopkins University, University of Chicago, MGH, 175 N. Medical Dr, Salt Lake City, UT 84132, USA.'}, {'ForeName': 'Natalia S', 'Initials': 'NS', 'LastName': 'Rost', 'Affiliation': 'Departments of Neurology: University of Utah, MUSC, Johns Hopkins University, University of Chicago, MGH, 175 N. Medical Dr, Salt Lake City, UT 84132, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'de Havenon', 'Affiliation': 'Departments of Neurology: University of Utah, MUSC, Johns Hopkins University, University of Chicago, MGH, 175 N. Medical Dr, Salt Lake City, UT 84132, USA. Electronic address: adam.dehavenon@hsc.utah.edu.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2021.105764'] 2851,33800559,Quadratus Lumborum and Transversus Abdominis Plane Blocks and Their Impact on Acute and Chronic Pain in Patients after Cesarean Section: A Randomized Controlled Study.,"BACKGROUND Severe postoperative pain is a significant problem after cesarean sections. METHODS This study was a randomized, controlled trial of 105 patients conducted in two hospitals. All patients were anesthetized spinally for elective cesarean section. Each participant was randomly allocated to one of three study groups: the quadratus lumborum block (QLB) group, the transversus abdominis plane block (TAPB) group, or the control (CON) group. The primary outcome of this study determined acute pain intensity on the visual analog scale (VAS). The secondary outcomes determined morphine consumption and chronic pain evaluation according to the Neuropathic Pain Symptom Inventory (NPSI) after hospital discharge. RESULTS At rest, the pain intensity was significantly higher in the CON group than in the QLB and TAPB groups at hours two and eight. Upon activity, the pain in the control subjects was more severe than in the QLB and TAPB groups in three and two of five measurements, respectively. Moreover, morphine consumption was significantly lower in the QLB (9 (5-10)) and TAPB (10 (6-14)) groups than in the CON (16 (11-19)) group. Persistent postoperative pain was significantly lower in the QLB group than in the CON group at months one and six following hospital discharge. CONCLUSIONS Both the QLB and TAPB can improve pain management after cesarean delivery. Moreover, the QLB might reduce the severity of persistent postoperative pain months after cesarean section.",2021,"Persistent postoperative pain was significantly lower in the QLB group than in the CON group at months one and six following hospital discharge. ","['All patients were anesthetized spinally for elective cesarean section', '105 patients conducted in two hospitals', 'Patients after Cesarean Section']","['QLB and TAPB', 'QLB', 'Quadratus Lumborum and Transversus Abdominis Plane Blocks', 'quadratus lumborum block (QLB) group, the transversus abdominis plane block (TAPB) group, or the control (CON', 'CON']","['pain', 'acute pain intensity on the visual analog scale (VAS', 'morphine consumption and chronic pain evaluation according to the Neuropathic Pain Symptom Inventory (NPSI) after hospital discharge', 'pain management', 'Persistent postoperative pain', 'pain intensity', 'morphine consumption', 'Acute and Chronic Pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1720436', 'cui_str': 'Under anesthesia'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",105.0,0.136913,"Persistent postoperative pain was significantly lower in the QLB group than in the CON group at months one and six following hospital discharge. ","[{'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Borys', 'Affiliation': 'Second Department of Anesthesia and Intensive Care, Medical University of Lublin, 20-059 Lublin, Poland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Zamaro', 'Affiliation': 'Department of Obstetrics and Perinatology, Faculty of Health Sciences, Medical University of Warsaw, 02-091 Warszawa, Poland.'}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Horeczy', 'Affiliation': 'Anesthesiology and Intensive Care Department with the Center for Acute Poisoning, St. Jadwiga Provincial Clinical Hospital, 35-301 Rzeszów, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Gęszka', 'Affiliation': 'Department of Obstetrics and Perinatology, Faculty of Health Sciences, Medical University of Warsaw, 02-091 Warszawa, Poland.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Janiak', 'Affiliation': 'First Department of Anesthesiology and Intensive Care, Medical University of Warsaw, 02-091 Warszawa, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Węgrzyn', 'Affiliation': 'Department of Obstetrics and Perinatology, Faculty of Health Sciences, Medical University of Warsaw, 02-091 Warszawa, Poland.'}, {'ForeName': 'Mirosław', 'Initials': 'M', 'LastName': 'Czuczwar', 'Affiliation': 'Second Department of Anesthesia and Intensive Care, Medical University of Lublin, 20-059 Lublin, Poland.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Piwowarczyk', 'Affiliation': 'Second Department of Anesthesia and Intensive Care, Medical University of Lublin, 20-059 Lublin, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph18073500'] 2852,33800555,Effect of Core Stabilizing Training on Young Individuals Presenting Different Stages of Degenerative Disc Disease-Preliminary Report.,"The aim of this study was to assess the efficacy of stabilizing training for the deep core muscles of the lumbar spine in subjects with degenerative disc disease. This study was conducted on 38 participants. The participants were divided into two groups: the extrusion group (EXT, n = 17) and the protrusion group (PRO, n = 21). All the subjects underwent a four-week-long core stability exercise-based treatment (five sessions/week). Clinical outcome measures were assessed pre-intervention (pre), post-intervention (post) and four weeks after the intervention (follow-up). The primary outcome measures were the spinal range of motion (ROM; Spinal Mouse ® device) and the Oswestry Disability Index (ODI). In the PRO group, the ROM decreased from 88.52° pre-intervention to 83.33° post-intervention and to 82.82° at follow-up ( p = 0.01), while the ODI decreased from 16.14 points pre-intervention to 6.57 points post-intervention, with 9.42 points at follow-up ( p < 0.01). In the EXT group, the ROM decreased from 81.00° pre-intervention to 77.05° post-intervention, then increased to 77.94° at follow-up ( p = 0.03), while the ODI decreased from 22.58 points pre-intervention to 15.41 points post-intervention and to 14.70 points at follow-up ( p < 0.001). Although the stabilizing exercise sessions improved the clinical outcomes in each group, we cannot make conclusions as to whether the type of intervertebral disc damage significantly affects the results of stabilizing exercise-based treatment.",2021,"In the PRO group, the ROM decreased from 88.52° pre-intervention to 83.33° post-intervention and to 82.82° at follow-up ( p = 0.01), while the ODI decreased from 16.14 points pre-intervention to 6.57 points post-intervention, with 9.42 points at follow-up ( p < 0.01).","['subjects with degenerative disc disease', '38 participants', 'Young Individuals Presenting Different Stages of Degenerative Disc Disease-Preliminary Report']","['extrusion group (EXT', 'stabilizing exercise sessions', 'stabilizing training', 'Core Stabilizing Training']","['ROM', 'ODI', 'spinal range of motion (ROM; Spinal Mouse ® device) and the Oswestry Disability Index (ODI']","[{'cui': 'C0158266', 'cui_str': 'Degeneration of intervertebral disc'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0443213', 'cui_str': 'Extrusion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015306', 'cui_str': 'Multiple congenital exostosis'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0444669', 'cui_str': 'Core'}]","[{'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}]",38.0,0.00640428,"In the PRO group, the ROM decreased from 88.52° pre-intervention to 83.33° post-intervention and to 82.82° at follow-up ( p = 0.01), while the ODI decreased from 16.14 points pre-intervention to 6.57 points post-intervention, with 9.42 points at follow-up ( p < 0.01).","[{'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Kuligowski', 'Affiliation': 'Faculty of Physiotherapy, University School of Physical Education in Wroclaw, 51-612 Wroclaw, Poland.'}, {'ForeName': 'Błażej', 'Initials': 'B', 'LastName': 'Cieślik', 'Affiliation': 'Faculty of Health Sciences, Jan Dlugosz University in Czestochowa, 42-200 Czestochowa, Poland.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Kuciel', 'Affiliation': 'Department and Division of Medical Rehabilitation, Wroclaw Medical University, 50-367 Wroclaw, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Dębiec-Bąk', 'Affiliation': 'Faculty of Physiotherapy, University School of Physical Education in Wroclaw, 51-612 Wroclaw, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Skrzek', 'Affiliation': 'Faculty of Physiotherapy, University School of Physical Education in Wroclaw, 51-612 Wroclaw, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph18073499'] 2853,33799921,"Impact of Annual Albendazole versus Four-Monthly Test-and-Treat Approach of Intestinal Parasites on Children Growth-A Longitudinal Four-Arm Randomized Parallel Trial during Two Years of a Community Follow-Up in Bengo, Angola.","Malnutrition and intestinal parasites continue to have serious impacts on growth and cognitive development of children in Angola. A longitudinal four-arm randomized parallel trial was conducted to investigate if deworming with a single annual dose of albendazole (annual-ALB) or a four-monthly test-and-treat (4TT) intestinal parasites approach at individual or household levels improve nutritional outcomes of pre-school children in Bengo province. Children with intestinal parasites (n = 121) were randomly assigned (1:1:1:1) to arm A1: annual-ALB*individual level; A2: annual-ALB*household level; A3: 4TT*individual; and A4: 4TT*household level. At baseline, 4, 8, 12, 16, 20, and 24 months of follow-up, growth was assessed by height, weight, height-for-age, weight-for-height, weight-for-age, and mid-upper arm circumference. Intention-to-treat analysis was done using non-parametric approach, mixed effect models, and generalized estimating equations (GEE). Initially, 57% and 26% of the children were infected by Giardia lamblia and Ascaris lumbricoides , respectively. This study did not show that a 4TT intestinal parasites approach results on better growth outcomes of children (height, weight, HAZ, WAZ, WHZ and MUACZ) when compared with annual ALB, with exception of height and WHZ using GEE model at 5% level. Positive temporal effects on most nutrition outcomes were observed. Implementing a longitudinal study in a poor setting is challenging and larger sample sizes and 'pure and clean' data are difficult to obtain. Nevertheless, learned lessons from this intensive study may contribute to future scientific research and to tailor multidisciplinary approaches to minimize malnutrition and infections in resource-poor countries.",2021,"This study did not show that a 4TT intestinal parasites approach results on better growth outcomes of children (height, weight, HAZ, WAZ, WHZ and MUACZ) when compared with annual ALB, with exception of height and WHZ using GEE model at 5% level.","['children in Angola', 'Children Growth-A Longitudinal Four-Arm Randomized Parallel Trial during Two Years of a Community Follow-Up in Bengo, Angola', 'pre-school children in Bengo province', 'Children with intestinal parasites (n = 121']","['albendazole (annual-ALB) or a four-monthly test-and-treat (4TT) intestinal parasites approach at individual or household levels', 'Annual Albendazole']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003023', 'cui_str': 'Angola'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0021832', 'cui_str': 'Intestinal parasitism'}]","[{'cui': 'C0001911', 'cui_str': 'Albendazole'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0021832', 'cui_str': 'Intestinal parasitism'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",[],121.0,0.221405,"This study did not show that a 4TT intestinal parasites approach results on better growth outcomes of children (height, weight, HAZ, WAZ, WHZ and MUACZ) when compared with annual ALB, with exception of height and WHZ using GEE model at 5% level.","[{'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Gasparinho', 'Affiliation': 'Centro de Investigação em Saúde de Angola (CISA), Rua Direita de Caxito, Caxito, Angola.'}, {'ForeName': 'Aguinaldo', 'Initials': 'A', 'LastName': 'Kanjungo', 'Affiliation': 'Centro de Investigação em Saúde de Angola (CISA), Rua Direita de Caxito, Caxito, Angola.'}, {'ForeName': 'Félix', 'Initials': 'F', 'LastName': 'Zage', 'Affiliation': 'Centro de Investigação em Saúde de Angola (CISA), Rua Direita de Caxito, Caxito, Angola.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Clemente', 'Affiliation': 'Centro de Investigação em Saúde de Angola (CISA), Rua Direita de Caxito, Caxito, Angola.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Santos-Reis', 'Affiliation': 'Global Health and Tropical Medicine (GHTM), Instituto de Higiene e Medicina Tropical (IHMT), Universidade Nova de Lisboa (UNL), 1349-008 Lisbon, Portugal.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Brito', 'Affiliation': 'Centro de Investigação em Saúde de Angola (CISA), Rua Direita de Caxito, Caxito, Angola.'}, {'ForeName': 'José Carlos', 'Initials': 'JC', 'LastName': 'Sousa-Figueiredo', 'Affiliation': 'Centro de Investigação em Saúde de Angola (CISA), Rua Direita de Caxito, Caxito, Angola.'}, {'ForeName': 'Filomeno', 'Initials': 'F', 'LastName': 'Fortes', 'Affiliation': 'Global Health and Tropical Medicine (GHTM), Instituto de Higiene e Medicina Tropical (IHMT), Universidade Nova de Lisboa (UNL), 1349-008 Lisbon, Portugal.'}, {'ForeName': 'Luzia', 'Initials': 'L', 'LastName': 'Gonçalves', 'Affiliation': 'Global Health and Tropical Medicine (GHTM), Instituto de Higiene e Medicina Tropical (IHMT), Universidade Nova de Lisboa (UNL), 1349-008 Lisbon, Portugal.'}]","Pathogens (Basel, Switzerland)",['10.3390/pathogens10030309'] 2854,33799874,New Insights into the Metabolism of the Flavanones Eriocitrin and Hesperidin: A Comparative Human Pharmacokinetic Study.,"The intake of hesperidin-rich sources, mostly found in orange juice, can decrease cardiometabolic risk, potentially linked to the gut microbial phase-II hesperetin derivatives. However, the low hesperidin solubility hampers its bioavailability and microbial metabolism, yielding a high inter-individual variability (high vs. low-producers) that prevents consistent health-related evidence. Contrarily, the human metabolism of (lemon) eriocitrin is hardly known. We hypothesize that the higher solubility of (lemon) eriocitrin vs. (orange) hesperidin might yield more bioavailable metabolites than hesperidin. A randomized-crossover human pharmacokinetic study ( n = 16) compared the bioavailability and metabolism of flavanones from lemon and orange extracts and postprandial changes in oxidative, inflammatory, and metabolic markers after a high-fat-high-sugars meal. A total of 17 phase-II flavanone-derived metabolites were identified. No significant biomarker changes were observed. Plasma and urinary concentrations of all metabolites, including hesperetin metabolites, were higher after lemon extract intake. Total plasma metabolites showed significantly mean lower T max (6.0 ± 0.4 vs. 8.0 ± 0.5 h) and higher C max and AUC values after lemon extract intake. We provide new insights on hesperetin-eriodictyol interconversion and naringenin formation from hesperidin in humans. Our results suggest that regular consumption of a soluble and eco-friendly eriocitrin-rich lemon extract could provide a circulating concentration metabolites threshold to exert health benefits, even in the so-called low-producers.",2021,"Plasma and urinary concentrations of all metabolites, including hesperetin metabolites, were higher after lemon extract intake.",['humans'],['Hesperidin'],"['higher C max and AUC values', 'Plasma and urinary concentrations of all metabolites, including hesperetin metabolites', 'Total plasma metabolites', 'bioavailability and metabolism of flavanones from lemon and orange extracts and postprandial changes in oxidative, inflammatory, and metabolic markers', 'bioavailable metabolites']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0019392', 'cui_str': 'Hesperidin'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0232827', 'cui_str': 'Urinary concentration'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0062585', 'cui_str': 'hesperetin'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0060425', 'cui_str': 'flavanone'}, {'cui': 'C0440283', 'cui_str': 'Citrus limon'}, {'cui': 'C2702329', 'cui_str': 'orange allergenic extract'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker'}, {'cui': 'C0935763', 'cui_str': 'Bioavailable'}]",,0.0486137,"Plasma and urinary concentrations of all metabolites, including hesperetin metabolites, were higher after lemon extract intake.","[{'ForeName': 'María Ángeles', 'Initials': 'MÁ', 'LastName': 'Ávila-Gálvez', 'Affiliation': 'Laboratory of Food and Health, Research Group on Quality, Safety and Bioactivity of Plant Foods, Department Food Science and Technology, Campus de Espinardo, CEBAS-CSIC, P.O. Box 164, 30100 Murcia, Spain.'}, {'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'Giménez-Bastida', 'Affiliation': 'Laboratory of Food and Health, Research Group on Quality, Safety and Bioactivity of Plant Foods, Department Food Science and Technology, Campus de Espinardo, CEBAS-CSIC, P.O. Box 164, 30100 Murcia, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'González-Sarrías', 'Affiliation': 'Laboratory of Food and Health, Research Group on Quality, Safety and Bioactivity of Plant Foods, Department Food Science and Technology, Campus de Espinardo, CEBAS-CSIC, P.O. Box 164, 30100 Murcia, Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Espín', 'Affiliation': 'Laboratory of Food and Health, Research Group on Quality, Safety and Bioactivity of Plant Foods, Department Food Science and Technology, Campus de Espinardo, CEBAS-CSIC, P.O. Box 164, 30100 Murcia, Spain.'}]","Antioxidants (Basel, Switzerland)",['10.3390/antiox10030435'] 2855,33799558,Superior Adaptations in Adolescent Runners Using Heart Rate Variability (HRV)-Guided Training at Altitude.,"We evaluated the efficacy of heart rate variability (HRV)-guided training in adolescent athletes during a 2-week, high altitude (≈1900 m) training camp. Sixteen middle- and long-distance runners (4 female/12 male, 16.9 ± 1.0 years, 65.44 ± 4.03 mL·kg -1 ·min -1 ) were divided into 2 matched groups, both of which received the same training plan, but one of which acquired postwaking HRV values that were used to tailor the training prescription. During the camp, seven athletes in the HRV-guided group combined for a total of 32 training adjustments, whereas there were only 3 runners combined for 14 total training adjustments in the control group. A significant group by time interaction ( p < 0.001) for VO 2 max was driven by VO 2 max improvements in the HRV group (+2.8 mL·kg -1 ·min -1 , +4.27%; p Bonf = 0.002) that were not observed in the control condition (+0.8 mL·kg -1 ·min -1 , +1.26%; p Bonf = 0.643). After returning from the camp, all athletes in the HRV group set a personal best, and six out of eight achieved their best positions in the National Championship, whereas only 75% of athletes in the control group set a personal best and five out of eight achieved their best positions in the National Championship. These data provide evidence in support of HRV-guided training as a way to optimize training prescriptions in adolescent athletes.",2021,"A significant group by time interaction ( p < 0.001) for VO 2 max was driven by VO 2 max improvements in the HRV group (+2.8 mL·kg -1 ·min -1 , +4.27%; p Bonf = 0.002) that were not observed in the control condition (+0.8 mL·kg -1 ·min -1 , +1.26%; p Bonf = 0.643).","['Adolescent Runners Using Heart Rate Variability', 'Sixteen middle- and long-distance runners (4 female/12 male, 16.9 ± 1.0 years, 65.44 ± 4.03 mL·kg -1 ·min -1 ', 'adolescent athletes during a 2-week, high altitude (≈1900 m) training camp', 'adolescent athletes']",['heart rate variability (HRV)-guided training'],['time interaction'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1301862', 'cui_str': 'Min 1'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0238617', 'cui_str': 'High altitude'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}]",,0.0173943,"A significant group by time interaction ( p < 0.001) for VO 2 max was driven by VO 2 max improvements in the HRV group (+2.8 mL·kg -1 ·min -1 , +4.27%; p Bonf = 0.002) that were not observed in the control condition (+0.8 mL·kg -1 ·min -1 , +1.26%; p Bonf = 0.643).","[{'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Bahenský', 'Affiliation': 'Department of Sports Studies, Faculty of Education, University of South Bohemia, 371 15 České Budějovice, Czech Republic.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Grosicki', 'Affiliation': 'Biodynamics and Human Performance Center, Georgia Southern University, Savannah, GA 31419, USA.'}]",Biosensors,['10.3390/bios11030077'] 2856,33799555,Acute Effects of Surgical and FFP2 Face Masks on Physiological Responses and Strength Performance in Persons with Sarcopenia.,"Due to COVID-19, wearing a face mask to reduce virus transmission is currently mandatory in some countries when participants practice exercise in sports centers. Therefore, the aim of the present study was to analyze the effect of wearing a surgical or FFP2 mask during a resistance training session. Fourteen people with sarcopenia (age: 59.40 ± 5.46 years; weight: 68.78 ± 8.31 kg; height: 163.84 ± 9.08 cm) that participated in the study performed three training sessions in a randomized order: 4 sets of 10 repetitions of a half-squat at 60% of the one-repetition maximum and 90 s of rest between set and were either (a) without a mask (NM), (b) wearing a surgical face mask (SM), and (c) wearing a FFP2 face mask (FFP2). We found that wearing face masks had no effect on strength performance (session mean propulsive velocity (m/s): WM: 0.396 ± 0.042; SM: 0.387 ± 0.037; and FFP2: 0.391 ± 0.042 ( p = 0.918)). Additionally, no impact of wearing a mask was found on heart rate, heart rate variability, blood lactate concentration (WM: 4.17 ± 1.89; SM: 4.49 ± 2.07; and FFP2: 5.28 ± 2.45 mmol/L ( p = 0.447)), or rating of perceived exertion. Wearing a surgical or FFP2 face mask during a resistance training session resulted in similar strength performance and physiological responses than the same exercise without a mask in persons with sarcopenia.",2021,"Additionally, no impact of wearing a mask was found on heart rate, heart rate variability, blood lactate concentration","['persons with sarcopenia', 'Persons with Sarcopenia', 'Fourteen people with sarcopenia (age: 59.40 ± 5.46 years; weight: 68.78 ± 8.31 kg; height: 163.84 ± 9.08 cm) that participated in the study performed three']","['half-squat at 60% of the one-repetition maximum and 90 s of rest between set and were either (a) without a mask (NM), (b) wearing a surgical face mask (SM), and (c) wearing a FFP2 face mask (FFP2', 'wearing a surgical or FFP2 mask', 'Surgical and FFP2 Face Masks', 'training sessions']","['Physiological Responses and Strength Performance', 'heart rate, heart rate variability, blood lactate concentration', 'strength performance and physiological responses', 'strength performance']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0181758', 'cui_str': 'Surgical face mask'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.015805,"Additionally, no impact of wearing a mask was found on heart rate, heart rate variability, blood lactate concentration","[{'ForeName': 'Domingo Jesús', 'Initials': 'DJ', 'LastName': 'Ramos-Campo', 'Affiliation': 'Department of Education, University of Alcalá, 28805 Madrid, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Pérez-Piñero', 'Affiliation': 'Department of Exercise Physiology, Universidad Católica San Antonio de Murcia, 30107 Murcia, Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Muñoz-Carrillo', 'Affiliation': 'Department of Exercise Physiology, Universidad Católica San Antonio de Murcia, 30107 Murcia, Spain.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'López-Román', 'Affiliation': 'Department of Exercise Physiology, Universidad Católica San Antonio de Murcia, 30107 Murcia, Spain.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'García-Sánchez', 'Affiliation': 'Fundación para la Formación e Invetigación Sanitarias de la Región de Murcia, 30003 Murcia, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Ávila-Gandía', 'Affiliation': 'Department of Exercise Physiology, Universidad Católica San Antonio de Murcia, 30107 Murcia, Spain.'}]",Biology,['10.3390/biology10030213'] 2857,33799542,Pharmacokinetics of Meropenem in People with Cystic Fibrosis-A Proof of Concept Clinical Trial.,"Anti-infective treatment of pulmonary exacerbations is a major issue in people with cystic fibrosis (CF). Individualized dosing strategies and adaptation of infusion times are important concepts to optimize anti-infective therapy. In this prospective non-randomized controlled open-label trial, we compared pharmacokinetics of meropenem in 12 people with CF experiencing a pulmonary exacerbation, of whom six received parenteral meropenem 2 g tid as short infusion over 30 min and six extended infusion over 120 min. We measured blood concentrations of meropenem at five predetermined time points over 240 min and calculated differences in the percentages of the time above the minimal inhibitory concentration (fT > MIC) for meropenem concentrations >16 and >32 mg/L, respectively. Mean percentages of fT > 16 and fT > 32 mg/L were higher in the extended compared to the short infusion group (83 and 56% vs. 59% and 34%), with a statistically significant prolongation of the fT > 32 mg/L (mean 134 vs. 82 min; p = 0.037). Our results demonstrate that, in people with CF, longer fT > MIC can be achieved with a simple modification of meropenem dosing. Further studies are needed to clarify if this may translate into improved microbiological and clinical outcomes, in particular in adults with difficult-to-treat chronic infection by carbapenem-resistant Pseudomonas aeruginosa .",2021,"Mean percentages of fT > 16 and fT > 32 mg/L were higher in the extended compared to the short infusion group (83 and 56% vs. 59% and 34%), with a statistically significant prolongation of the fT > 32 mg/L (mean 134 vs. 82 min; p = 0.037).","['12 people with CF experiencing a pulmonary exacerbation', 'People with Cystic Fibrosis', 'people with cystic fibrosis (CF', 'adults with difficult-to-treat chronic infection by carbapenem-resistant Pseudomonas aeruginosa ']","['meropenem', 'Meropenem', 'parenteral meropenem 2 g tid as short infusion over 30 min and six extended infusion over 120 min']",['blood concentrations of meropenem'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0151317', 'cui_str': 'Chronic infectious disease'}, {'cui': 'C0006968', 'cui_str': 'Carbapenem'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0033809', 'cui_str': 'Pseudomonas aeruginosa'}]","[{'cui': 'C0066005', 'cui_str': 'meropenem'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0427728', 'cui_str': 'Blood concentration, dipstick - finding'}, {'cui': 'C0066005', 'cui_str': 'meropenem'}]",12.0,0.0635549,"Mean percentages of fT > 16 and fT > 32 mg/L were higher in the extended compared to the short infusion group (83 and 56% vs. 59% and 34%), with a statistically significant prolongation of the fT > 32 mg/L (mean 134 vs. 82 min; p = 0.037).","[{'ForeName': 'Jan C', 'Initials': 'JC', 'LastName': 'Kamp', 'Affiliation': 'Department of Respiratory Medicine, Hannover Medical School, 30625 Hannover, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Fuge', 'Affiliation': 'Department of Respiratory Medicine, Hannover Medical School, 30625 Hannover, Germany.'}, {'ForeName': 'Felix C', 'Initials': 'FC', 'LastName': 'Ringshausen', 'Affiliation': 'Department of Respiratory Medicine, Hannover Medical School, 30625 Hannover, Germany.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Grote-Koska', 'Affiliation': 'Institute of Clinical Chemistry, Hannover Medical School, 30625 Hannover, Germany.'}, {'ForeName': 'Korbinian', 'Initials': 'K', 'LastName': 'Brand', 'Affiliation': 'Institute of Clinical Chemistry, Hannover Medical School, 30625 Hannover, Germany.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Graalmann', 'Affiliation': 'Department of Respiratory Medicine, Hannover Medical School, 30625 Hannover, Germany.'}, {'ForeName': 'Ralf-Peter', 'Initials': 'RP', 'LastName': 'Vonberg', 'Affiliation': 'Institute for Medical Microbiology and Hospital Epidemiology, Hannover Medical School, 30625 Hannover, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Welte', 'Affiliation': 'Department of Respiratory Medicine, Hannover Medical School, 30625 Hannover, Germany.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Rademacher', 'Affiliation': 'Department of Respiratory Medicine, Hannover Medical School, 30625 Hannover, Germany.'}]","Antibiotics (Basel, Switzerland)",['10.3390/antibiotics10030292'] 2858,33799486,A Multi-Mineral Intervention to Modulate Colonic Mucosal Protein Profile: Results from a 90-Day Trial in Human Subjects.,"The overall goal of this study was to determine whether Aquamin ® , a calcium-, magnesium-, trace element-rich, red algae-derived natural product, would alter the expression of proteins involved in growth-regulation and differentiation in colon. Thirty healthy human subjects (at risk for colorectal cancer) were enrolled in a three-arm, 90-day interventional trial. Aquamin ® was compared to calcium alone and placebo. Before and after the interventional period, colonic biopsies were obtained. Biopsies were evaluated by immunohistology for expression of Ki67 (proliferation marker) and for CK20 and p21 (differentiation markers). Tandem mass tag-mass spectrometry-based detection was used to assess levels of multiple proteins. As compared to placebo or calcium, Aquamin ® reduced the level of Ki67 expression and slightly increased CK20 expression. Increased p21 expression was observed with both calcium and Aquamin ® . In proteomic screen, Aquamin ® treatment resulted in many more proteins being upregulated (including pro-apoptotic, cytokeratins, cell-cell adhesion molecules, and components of the basement membrane) or downregulated (proliferation and nucleic acid metabolism) than placebo. Calcium alone also altered the expression of many of the same proteins but not to the same extent as Aquamin ® . We conclude that daily Aquamin ® ingestion alters protein expression profile in the colon that could be beneficial to colonic health.",2021,"As compared to placebo or calcium, Aquamin ® reduced the level of Ki67 expression and slightly increased CK20 expression.","['Thirty healthy human subjects (at risk for colorectal cancer', 'Human Subjects']","['Calcium', 'placebo', 'Multi-Mineral Intervention', 'calcium alone and placebo']","['immunohistology for expression of Ki67 (proliferation marker) and for CK20 and p21 (differentiation markers', 'Increased p21 expression', 'CK20 expression', 'level of Ki67 expression']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0334094', 'cui_str': 'Proliferation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0080058', 'cui_str': 'Proto-Oncogene Protein p21(ras)'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",30.0,0.0828887,"As compared to placebo or calcium, Aquamin ® reduced the level of Ki67 expression and slightly increased CK20 expression.","[{'ForeName': 'Muhammad N', 'Initials': 'MN', 'LastName': 'Aslam', 'Affiliation': 'Department of Pathology, The University of Michigan Medical School, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Shannon D', 'Initials': 'SD', 'LastName': 'McClintock', 'Affiliation': 'Department of Pathology, The University of Michigan Medical School, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Mohamed Ali H', 'Initials': 'MAH', 'LastName': 'Jawad-Makki', 'Affiliation': 'Department of Pathology, The University of Michigan Medical School, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Knuver', 'Affiliation': 'Department of Pathology, The University of Michigan Medical School, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Haris M', 'Initials': 'HM', 'LastName': 'Ahmad', 'Affiliation': 'Department of Pathology, The University of Michigan Medical School, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Venkatesha', 'Initials': 'V', 'LastName': 'Basrur', 'Affiliation': 'Department of Pathology, The University of Michigan Medical School, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Ingrid L', 'Initials': 'IL', 'LastName': 'Bergin', 'Affiliation': 'The Unit for Laboratory Animal Medicine, The University of Michigan Medical School, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Suzanna M', 'Initials': 'SM', 'LastName': 'Zick', 'Affiliation': 'Department of Family Medicine, The University of Michigan Medical School, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Ananda', 'Initials': 'A', 'LastName': 'Sen', 'Affiliation': 'Department of Family Medicine, The University of Michigan Medical School, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'D Kim', 'Initials': 'DK', 'LastName': 'Turgeon', 'Affiliation': 'Department of Internal Medicine (Division of Gastroenterology), The University of Michigan Medical School, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Varani', 'Affiliation': 'Department of Pathology, The University of Michigan Medical School, Ann Arbor, MI 48109, USA.'}]",Nutrients,['10.3390/nu13030939'] 2859,33789010,"Lumasiran, an RNAi Therapeutic for Primary Hyperoxaluria Type 1.","BACKGROUND Primary hyperoxaluria type 1 (PH1) is a rare genetic disease caused by hepatic overproduction of oxalate that leads to kidney stones, nephrocalcinosis, kidney failure, and systemic oxalosis. Lumasiran, an investigational RNA interference (RNAi) therapeutic agent, reduces hepatic oxalate production by targeting glycolate oxidase. METHODS In this double-blind, phase 3 trial, we randomly assigned (in a 2:1 ratio) patients with PH1 who were 6 years of age or older to receive subcutaneous lumasiran or placebo for 6 months (with doses given at baseline and at months 1, 2, 3, and 6). The primary end point was the percent change in 24-hour urinary oxalate excretion from baseline to month 6 (mean percent change across months 3 through 6). Secondary end points included the percent change in the plasma oxalate level from baseline to month 6 (mean percent change across months 3 through 6) and the percentage of patients with 24-hour urinary oxalate excretion no higher than 1.5 times the upper limit of the normal range at month 6. RESULTS A total of 39 patients underwent randomization; 26 were assigned to the lumasiran group and 13 to the placebo group. The least-squares mean difference in the change in 24-hour urinary oxalate excretion (lumasiran minus placebo) was -53.5 percentage points (P<0.001), with a reduction in the lumasiran group of 65.4% and an effect seen as early as month 1. The between-group differences for all hierarchically tested secondary end points were significant. The difference in the percent change in the plasma oxalate level (lumasiran minus placebo) was -39.5 percentage points (P<0.001). In the lumasiran group, 84% of patients had 24-hour urinary oxalate excretion no higher than 1.5 times the upper limit of the normal range at month 6, as compared with 0% in the placebo group (P<0.001). Mild, transient injection-site reactions were reported in 38% of lumasiran-treated patients. CONCLUSIONS Lumasiran reduced urinary oxalate excretion, the cause of progressive kidney failure in PH1. The majority of patients who received lumasiran had normal or near-normal levels after 6 months of treatment. (Funded by Alnylam Pharmaceuticals; ILLUMINATE-A ClinicalTrials.gov number, NCT03681184.).",2021,"Lumasiran, an investigational RNA interference (RNAi) therapeutic agent, reduces hepatic oxalate production by targeting glycolate oxidase. ","['for 6 months (with doses given at baseline and at months 1, 2, 3, and 6', '39 patients underwent randomization; 26 were assigned to the lumasiran group and 13 to the', '2:1 ratio) patients with PH1 who were 6 years of age or older to receive']","['placebo', 'subcutaneous lumasiran or placebo']","['hepatic oxalate production', 'plasma oxalate level', 'normal or near-normal levels', '24-hour urinary oxalate excretion', 'Mild, transient injection-site reactions', '24-hour urinary oxalate excretion (lumasiran minus placebo', 'urinary oxalate excretion']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0268164', 'cui_str': 'Primary hyperoxaluria, type I'}, {'cui': 'C0444858', 'cui_str': 'AM 6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0029988', 'cui_str': 'Oxalate'}, {'cui': 'C1318658', 'cui_str': 'Plasma oxalate level'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",39.0,0.582818,"Lumasiran, an investigational RNA interference (RNAi) therapeutic agent, reduces hepatic oxalate production by targeting glycolate oxidase. ","[{'ForeName': 'Sander F', 'Initials': 'SF', 'LastName': 'Garrelfs', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Yaacov', 'Initials': 'Y', 'LastName': 'Frishberg', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Sally A', 'Initials': 'SA', 'LastName': 'Hulton', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Koren', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': ""O'Riordan"", 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Cochat', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Deschênes', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Hadas', 'Initials': 'H', 'LastName': 'Shasha-Lavsky', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Saland', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': ""Van't Hoff"", 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Daniel G', 'Initials': 'DG', 'LastName': 'Fuster', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Daniella', 'Initials': 'D', 'LastName': 'Magen', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Shabbir H', 'Initials': 'SH', 'LastName': 'Moochhala', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Gesa', 'Initials': 'G', 'LastName': 'Schalk', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Simkova', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Jaap W', 'Initials': 'JW', 'LastName': 'Groothoff', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Sas', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Kristin A', 'Initials': 'KA', 'LastName': 'Meliambro', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Jiandong', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Marianne T', 'Initials': 'MT', 'LastName': 'Sweetser', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Pushkal P', 'Initials': 'PP', 'LastName': 'Garg', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Akshay K', 'Initials': 'AK', 'LastName': 'Vaishnaw', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Gansner', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'McGregor', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Lieske', 'Affiliation': ""From the Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam (S.F.G., J.W.G.); the Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem (Y.F.); the Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham (S.A.H.), and the Department of Paediatric Nephrology, Great Ormond Street Hospital (W.G.H.), and UCL Department of Renal Medicine, Royal Free Hospital (S.H.M.), London - both in the United Kingdom; Jacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); eStudySite, San Diego, CA (W.D.O.); Center for Rare Renal Diseases and INSERM Pediatric Clinical Investigation Center-Hospices Civils de Lyon and Université de Lyon, Lyon (P.C.), and the Department of Pediatric Nephrology, Hôpital Robert-Debré, Paris (G.D.) - both in France; the Pediatric Nephrology Unit, Galilee Medical Center, Nahariya (H.S.-L.), and the Pediatric Nephrology Institute, Rambam Health Care Campus, Haifa (D.M.) - both in Israel; the Icahn School of Medicine at Mount Sinai, New York (J.M.S., K.A.M.); the Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.G.F.); the University of Bonn, Bonn, Germany (G.S.); Al Jalila Children's Hospital, Dubai, United Arab Emirates (E.S.); the Divisions of Pediatric Nephrology and Hypertension (D.J.S.) and Nephrology and Hypertension (J.C.L.), Mayo Clinic, Rochester, MN; and Alnylam Pharmaceuticals, Cambridge, MA (J.L., M.T.S., P.P.G., A.K.V., J.M.G., T.L.M.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2021712'] 2860,33789011,Trial of Upadacitinib and Adalimumab for Psoriatic Arthritis.,"BACKGROUND The Janus kinase inhibitor upadacitinib is a potential treatment for psoriatic arthritis. The efficacy and safety of upadacitinib as compared with adalimumab, a tumor necrosis factor α inhibitor, in patients who have an inadequate response to nonbiologic disease-modifying antirheumatic drugs are unclear. METHODS In a 24-week, phase 3 trial, we randomly assigned patients in a 1:1:1:1 ratio to receive oral upadacitinib at a dose of 15 mg or 30 mg once daily, placebo, or subcutaneous adalimumab (40 mg every other week). The primary end point was an American College of Rheumatology 20 (ACR20) response (≥20% decrease in the number of tender and swollen joints and ≥20% improvement in at least three of five other domains) at week 12 with upadacitinib as compared with placebo. Secondary end points included comparisons of upadacitinib with adalimumab. RESULTS A total of 1704 patients received an active drug or placebo. The percentage of patients who had an ACR20 response at week 12 was 70.6% with 15-mg upadacitinib, 78.5% with 30-mg upadacitinib, 36.2% with placebo (P<0.001 for both upadacitinib doses vs. placebo), and 65.0% with adalimumab. The difference between groups for 15-mg upadacitinib as compared with adalimumab was 5.6 percentage points (95% confidence interval [CI], -0.6 to 11.8) and for 30-mg upadacitinib as compared with adalimumab was 13.5 percentage points (95% CI, 7.5 to 19.4). Both upadacitinib doses were noninferior to adalimumab for the ACR20 response at week 12; the 30-mg dose but not the 15-mg dose was superior to adalimumab. The incidence of adverse events through week 24 was 66.9% with 15-mg upadacitinib, 72.3% with 30-mg upadacitinib, 59.6% with placebo, and 64.8% with adalimumab. There were serious infections in 1.2%, 2.6%, 0.9%, and 0.7% of the patients, respectively. Hepatic disorders occurred in 9.1% of patients in the 15-mg upadacitinib group and 12.3% in the 30-mg upadacitinib group, but grade 3 increases in aminotransferase levels occurred in 2% of patients or fewer in all groups. CONCLUSIONS The percentage of patients with psoriatic arthritis who had an ACR20 response at week 12 was significantly higher with 15-mg or 30-mg upadacitinib than with placebo. The 30-mg dose but not the 15-mg dose was superior to adalimumab. Adverse events were more frequent with upadacitinib than with placebo. (Funded by AbbVie; SELECT-PsA 1 ClinicalTrials.gov number, NCT03104400.).",2021,Both upadacitinib doses were noninferior to adalimumab for the ACR20 response at week 12; the 30-mg dose but not the 15-mg dose was superior to adalimumab.,"['psoriatic arthritis', '1704 patients received an', 'Psoriatic Arthritis', 'patients who have an inadequate response to nonbiologic disease-modifying antirheumatic drugs are unclear']","['active drug or placebo', 'placebo', 'Upadacitinib and Adalimumab', 'oral upadacitinib at a dose of 15 mg or 30 mg once daily, placebo, or subcutaneous adalimumab', 'adalimumab']","['American College of Rheumatology 20 (ACR20) response', 'comparisons of upadacitinib with adalimumab', 'Hepatic disorders', 'serious infections', 'number of tender and swollen joints', 'Adverse events', 'ACR20 response', 'incidence of adverse events', 'aminotransferase levels']","[{'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4726929', 'cui_str': 'upadacitinib'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C4726929', 'cui_str': 'upadacitinib'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0234234', 'cui_str': 'Tender'}, {'cui': 'C0152031', 'cui_str': 'Joint swelling'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",1704.0,0.177611,Both upadacitinib doses were noninferior to adalimumab for the ACR20 response at week 12; the 30-mg dose but not the 15-mg dose was superior to adalimumab.,"[{'ForeName': 'Iain B', 'Initials': 'IB', 'LastName': 'McInnes', 'Affiliation': ""From the College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, United Kingdom (I.B.M.); AbbVie, North Chicago, IL (J.K.A., X.W., L.C., P.Z., J.L., A.L.P.); Case Western Reserve University School of Medicine at MetroHealth Medical Center, Cleveland (M.M.); Brigham and Women's Hospital and Harvard Medical School, Boston (J.F.M.); the Department of Rheumatology, West China Hospital, Sichuan University, Chengdu, China (Y.L.); the Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo (M.K.); the Department of Rheumatology and Connective Tissue Diseases, Collegium Medicum Uniwersytet Mikołaja Kopernika, 2nd University Hospital, Bydgoszcz, Poland (S.J.); Facultad de Medicina, Universidad Autonoma de Chihuahua, Chihuahua, Mexico (C.P.-T.); and Goethe University and Fraunhofer Institute for Molecular Biology and Applied Ecology-Branch for Translational Medicine and Pharmacology and Cluster of Excellence for Immune-Mediated Diseases, Frankfurt, Germany (F.B.).""}, {'ForeName': 'Jaclyn K', 'Initials': 'JK', 'LastName': 'Anderson', 'Affiliation': ""From the College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, United Kingdom (I.B.M.); AbbVie, North Chicago, IL (J.K.A., X.W., L.C., P.Z., J.L., A.L.P.); Case Western Reserve University School of Medicine at MetroHealth Medical Center, Cleveland (M.M.); Brigham and Women's Hospital and Harvard Medical School, Boston (J.F.M.); the Department of Rheumatology, West China Hospital, Sichuan University, Chengdu, China (Y.L.); the Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo (M.K.); the Department of Rheumatology and Connective Tissue Diseases, Collegium Medicum Uniwersytet Mikołaja Kopernika, 2nd University Hospital, Bydgoszcz, Poland (S.J.); Facultad de Medicina, Universidad Autonoma de Chihuahua, Chihuahua, Mexico (C.P.-T.); and Goethe University and Fraunhofer Institute for Molecular Biology and Applied Ecology-Branch for Translational Medicine and Pharmacology and Cluster of Excellence for Immune-Mediated Diseases, Frankfurt, Germany (F.B.).""}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Magrey', 'Affiliation': ""From the College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, United Kingdom (I.B.M.); AbbVie, North Chicago, IL (J.K.A., X.W., L.C., P.Z., J.L., A.L.P.); Case Western Reserve University School of Medicine at MetroHealth Medical Center, Cleveland (M.M.); Brigham and Women's Hospital and Harvard Medical School, Boston (J.F.M.); the Department of Rheumatology, West China Hospital, Sichuan University, Chengdu, China (Y.L.); the Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo (M.K.); the Department of Rheumatology and Connective Tissue Diseases, Collegium Medicum Uniwersytet Mikołaja Kopernika, 2nd University Hospital, Bydgoszcz, Poland (S.J.); Facultad de Medicina, Universidad Autonoma de Chihuahua, Chihuahua, Mexico (C.P.-T.); and Goethe University and Fraunhofer Institute for Molecular Biology and Applied Ecology-Branch for Translational Medicine and Pharmacology and Cluster of Excellence for Immune-Mediated Diseases, Frankfurt, Germany (F.B.).""}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Merola', 'Affiliation': ""From the College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, United Kingdom (I.B.M.); AbbVie, North Chicago, IL (J.K.A., X.W., L.C., P.Z., J.L., A.L.P.); Case Western Reserve University School of Medicine at MetroHealth Medical Center, Cleveland (M.M.); Brigham and Women's Hospital and Harvard Medical School, Boston (J.F.M.); the Department of Rheumatology, West China Hospital, Sichuan University, Chengdu, China (Y.L.); the Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo (M.K.); the Department of Rheumatology and Connective Tissue Diseases, Collegium Medicum Uniwersytet Mikołaja Kopernika, 2nd University Hospital, Bydgoszcz, Poland (S.J.); Facultad de Medicina, Universidad Autonoma de Chihuahua, Chihuahua, Mexico (C.P.-T.); and Goethe University and Fraunhofer Institute for Molecular Biology and Applied Ecology-Branch for Translational Medicine and Pharmacology and Cluster of Excellence for Immune-Mediated Diseases, Frankfurt, Germany (F.B.).""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""From the College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, United Kingdom (I.B.M.); AbbVie, North Chicago, IL (J.K.A., X.W., L.C., P.Z., J.L., A.L.P.); Case Western Reserve University School of Medicine at MetroHealth Medical Center, Cleveland (M.M.); Brigham and Women's Hospital and Harvard Medical School, Boston (J.F.M.); the Department of Rheumatology, West China Hospital, Sichuan University, Chengdu, China (Y.L.); the Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo (M.K.); the Department of Rheumatology and Connective Tissue Diseases, Collegium Medicum Uniwersytet Mikołaja Kopernika, 2nd University Hospital, Bydgoszcz, Poland (S.J.); Facultad de Medicina, Universidad Autonoma de Chihuahua, Chihuahua, Mexico (C.P.-T.); and Goethe University and Fraunhofer Institute for Molecular Biology and Applied Ecology-Branch for Translational Medicine and Pharmacology and Cluster of Excellence for Immune-Mediated Diseases, Frankfurt, Germany (F.B.).""}, {'ForeName': 'Mitsumasa', 'Initials': 'M', 'LastName': 'Kishimoto', 'Affiliation': ""From the College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, United Kingdom (I.B.M.); AbbVie, North Chicago, IL (J.K.A., X.W., L.C., P.Z., J.L., A.L.P.); Case Western Reserve University School of Medicine at MetroHealth Medical Center, Cleveland (M.M.); Brigham and Women's Hospital and Harvard Medical School, Boston (J.F.M.); the Department of Rheumatology, West China Hospital, Sichuan University, Chengdu, China (Y.L.); the Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo (M.K.); the Department of Rheumatology and Connective Tissue Diseases, Collegium Medicum Uniwersytet Mikołaja Kopernika, 2nd University Hospital, Bydgoszcz, Poland (S.J.); Facultad de Medicina, Universidad Autonoma de Chihuahua, Chihuahua, Mexico (C.P.-T.); and Goethe University and Fraunhofer Institute for Molecular Biology and Applied Ecology-Branch for Translational Medicine and Pharmacology and Cluster of Excellence for Immune-Mediated Diseases, Frankfurt, Germany (F.B.).""}, {'ForeName': 'Slawomir', 'Initials': 'S', 'LastName': 'Jeka', 'Affiliation': ""From the College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, United Kingdom (I.B.M.); AbbVie, North Chicago, IL (J.K.A., X.W., L.C., P.Z., J.L., A.L.P.); Case Western Reserve University School of Medicine at MetroHealth Medical Center, Cleveland (M.M.); Brigham and Women's Hospital and Harvard Medical School, Boston (J.F.M.); the Department of Rheumatology, West China Hospital, Sichuan University, Chengdu, China (Y.L.); the Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo (M.K.); the Department of Rheumatology and Connective Tissue Diseases, Collegium Medicum Uniwersytet Mikołaja Kopernika, 2nd University Hospital, Bydgoszcz, Poland (S.J.); Facultad de Medicina, Universidad Autonoma de Chihuahua, Chihuahua, Mexico (C.P.-T.); and Goethe University and Fraunhofer Institute for Molecular Biology and Applied Ecology-Branch for Translational Medicine and Pharmacology and Cluster of Excellence for Immune-Mediated Diseases, Frankfurt, Germany (F.B.).""}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Pacheco-Tena', 'Affiliation': ""From the College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, United Kingdom (I.B.M.); AbbVie, North Chicago, IL (J.K.A., X.W., L.C., P.Z., J.L., A.L.P.); Case Western Reserve University School of Medicine at MetroHealth Medical Center, Cleveland (M.M.); Brigham and Women's Hospital and Harvard Medical School, Boston (J.F.M.); the Department of Rheumatology, West China Hospital, Sichuan University, Chengdu, China (Y.L.); the Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo (M.K.); the Department of Rheumatology and Connective Tissue Diseases, Collegium Medicum Uniwersytet Mikołaja Kopernika, 2nd University Hospital, Bydgoszcz, Poland (S.J.); Facultad de Medicina, Universidad Autonoma de Chihuahua, Chihuahua, Mexico (C.P.-T.); and Goethe University and Fraunhofer Institute for Molecular Biology and Applied Ecology-Branch for Translational Medicine and Pharmacology and Cluster of Excellence for Immune-Mediated Diseases, Frankfurt, Germany (F.B.).""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""From the College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, United Kingdom (I.B.M.); AbbVie, North Chicago, IL (J.K.A., X.W., L.C., P.Z., J.L., A.L.P.); Case Western Reserve University School of Medicine at MetroHealth Medical Center, Cleveland (M.M.); Brigham and Women's Hospital and Harvard Medical School, Boston (J.F.M.); the Department of Rheumatology, West China Hospital, Sichuan University, Chengdu, China (Y.L.); the Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo (M.K.); the Department of Rheumatology and Connective Tissue Diseases, Collegium Medicum Uniwersytet Mikołaja Kopernika, 2nd University Hospital, Bydgoszcz, Poland (S.J.); Facultad de Medicina, Universidad Autonoma de Chihuahua, Chihuahua, Mexico (C.P.-T.); and Goethe University and Fraunhofer Institute for Molecular Biology and Applied Ecology-Branch for Translational Medicine and Pharmacology and Cluster of Excellence for Immune-Mediated Diseases, Frankfurt, Germany (F.B.).""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""From the College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, United Kingdom (I.B.M.); AbbVie, North Chicago, IL (J.K.A., X.W., L.C., P.Z., J.L., A.L.P.); Case Western Reserve University School of Medicine at MetroHealth Medical Center, Cleveland (M.M.); Brigham and Women's Hospital and Harvard Medical School, Boston (J.F.M.); the Department of Rheumatology, West China Hospital, Sichuan University, Chengdu, China (Y.L.); the Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo (M.K.); the Department of Rheumatology and Connective Tissue Diseases, Collegium Medicum Uniwersytet Mikołaja Kopernika, 2nd University Hospital, Bydgoszcz, Poland (S.J.); Facultad de Medicina, Universidad Autonoma de Chihuahua, Chihuahua, Mexico (C.P.-T.); and Goethe University and Fraunhofer Institute for Molecular Biology and Applied Ecology-Branch for Translational Medicine and Pharmacology and Cluster of Excellence for Immune-Mediated Diseases, Frankfurt, Germany (F.B.).""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Zueger', 'Affiliation': ""From the College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, United Kingdom (I.B.M.); AbbVie, North Chicago, IL (J.K.A., X.W., L.C., P.Z., J.L., A.L.P.); Case Western Reserve University School of Medicine at MetroHealth Medical Center, Cleveland (M.M.); Brigham and Women's Hospital and Harvard Medical School, Boston (J.F.M.); the Department of Rheumatology, West China Hospital, Sichuan University, Chengdu, China (Y.L.); the Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo (M.K.); the Department of Rheumatology and Connective Tissue Diseases, Collegium Medicum Uniwersytet Mikołaja Kopernika, 2nd University Hospital, Bydgoszcz, Poland (S.J.); Facultad de Medicina, Universidad Autonoma de Chihuahua, Chihuahua, Mexico (C.P.-T.); and Goethe University and Fraunhofer Institute for Molecular Biology and Applied Ecology-Branch for Translational Medicine and Pharmacology and Cluster of Excellence for Immune-Mediated Diseases, Frankfurt, Germany (F.B.).""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""From the College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, United Kingdom (I.B.M.); AbbVie, North Chicago, IL (J.K.A., X.W., L.C., P.Z., J.L., A.L.P.); Case Western Reserve University School of Medicine at MetroHealth Medical Center, Cleveland (M.M.); Brigham and Women's Hospital and Harvard Medical School, Boston (J.F.M.); the Department of Rheumatology, West China Hospital, Sichuan University, Chengdu, China (Y.L.); the Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo (M.K.); the Department of Rheumatology and Connective Tissue Diseases, Collegium Medicum Uniwersytet Mikołaja Kopernika, 2nd University Hospital, Bydgoszcz, Poland (S.J.); Facultad de Medicina, Universidad Autonoma de Chihuahua, Chihuahua, Mexico (C.P.-T.); and Goethe University and Fraunhofer Institute for Molecular Biology and Applied Ecology-Branch for Translational Medicine and Pharmacology and Cluster of Excellence for Immune-Mediated Diseases, Frankfurt, Germany (F.B.).""}, {'ForeName': 'Aileen L', 'Initials': 'AL', 'LastName': 'Pangan', 'Affiliation': ""From the College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, United Kingdom (I.B.M.); AbbVie, North Chicago, IL (J.K.A., X.W., L.C., P.Z., J.L., A.L.P.); Case Western Reserve University School of Medicine at MetroHealth Medical Center, Cleveland (M.M.); Brigham and Women's Hospital and Harvard Medical School, Boston (J.F.M.); the Department of Rheumatology, West China Hospital, Sichuan University, Chengdu, China (Y.L.); the Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo (M.K.); the Department of Rheumatology and Connective Tissue Diseases, Collegium Medicum Uniwersytet Mikołaja Kopernika, 2nd University Hospital, Bydgoszcz, Poland (S.J.); Facultad de Medicina, Universidad Autonoma de Chihuahua, Chihuahua, Mexico (C.P.-T.); and Goethe University and Fraunhofer Institute for Molecular Biology and Applied Ecology-Branch for Translational Medicine and Pharmacology and Cluster of Excellence for Immune-Mediated Diseases, Frankfurt, Germany (F.B.).""}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Behrens', 'Affiliation': ""From the College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, United Kingdom (I.B.M.); AbbVie, North Chicago, IL (J.K.A., X.W., L.C., P.Z., J.L., A.L.P.); Case Western Reserve University School of Medicine at MetroHealth Medical Center, Cleveland (M.M.); Brigham and Women's Hospital and Harvard Medical School, Boston (J.F.M.); the Department of Rheumatology, West China Hospital, Sichuan University, Chengdu, China (Y.L.); the Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo (M.K.); the Department of Rheumatology and Connective Tissue Diseases, Collegium Medicum Uniwersytet Mikołaja Kopernika, 2nd University Hospital, Bydgoszcz, Poland (S.J.); Facultad de Medicina, Universidad Autonoma de Chihuahua, Chihuahua, Mexico (C.P.-T.); and Goethe University and Fraunhofer Institute for Molecular Biology and Applied Ecology-Branch for Translational Medicine and Pharmacology and Cluster of Excellence for Immune-Mediated Diseases, Frankfurt, Germany (F.B.).""}]",The New England journal of medicine,['10.1056/NEJMoa2022516'] 2861,33789009,Sotatercept for the Treatment of Pulmonary Arterial Hypertension.,"BACKGROUND Pulmonary arterial hypertension is characterized by pulmonary vascular remodeling, cellular proliferation, and poor long-term outcomes. Dysfunctional bone morphogenetic protein pathway signaling is associated with both hereditary and idiopathic subtypes. Sotatercept, a novel fusion protein, binds activins and growth differentiation factors in the attempt to restore balance between growth-promoting and growth-inhibiting signaling pathways. METHODS In this 24-week multicenter trial, we randomly assigned 106 adults who were receiving background therapy for pulmonary arterial hypertension to receive subcutaneous sotatercept at a dose of 0.3 mg per kilogram of body weight every 3 weeks or 0.7 mg per kilogram every 3 weeks or placebo. The primary end point was the change from baseline to week 24 in pulmonary vascular resistance. RESULTS Baseline characteristics were similar among the three groups. The least-squares mean difference between the sotatercept 0.3-mg group and the placebo group in the change from baseline to week 24 in pulmonary vascular resistance was -145.8 dyn · sec · cm -5 (95% confidence interval [CI], -241.0 to -50.6; P = 0.003). The least-squares mean difference between the sotatercept 0.7-mg group and the placebo group was -239.5 dyn · sec · cm -5 (95% CI, -329.3 to -149.7; P<0.001). At 24 weeks, the least-squares mean difference between the sotatercept 0.3-mg group and the placebo group in the change from baseline in 6-minute walk distance was 29.4 m (95% CI, 3.8 to 55.0). The least-squares mean difference between the sotatercept 0.7-mg group and the placebo group was 21.4 m (95% CI, -2.8 to 45.7). Sotatercept was also associated with a decrease in N-terminal pro-B-type natriuretic peptide levels. Thrombocytopenia and an increased hemoglobin level were the most common hematologic adverse events. One patient in the sotatercept 0.7-mg group died from cardiac arrest. CONCLUSIONS Treatment with sotatercept resulted in a reduction in pulmonary vascular resistance in patients receiving background therapy for pulmonary arterial hypertension. (Funded by Acceleron Pharma; PULSAR ClinicalTrials.gov number, NCT03496207.).",2021,Sotatercept was also associated with a decrease in N-terminal pro-B-type natriuretic peptide levels.,"['patients receiving background therapy for pulmonary arterial hypertension', '106 adults who were receiving background therapy for pulmonary arterial hypertension to receive', 'Pulmonary Arterial Hypertension']","['placebo', 'subcutaneous sotatercept']","['Thrombocytopenia', '6-minute walk distance', 'hemoglobin level', 'pulmonary vascular resistance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary arterial hypertension'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary vascular resistance'}]",106.0,0.322826,Sotatercept was also associated with a decrease in N-terminal pro-B-type natriuretic peptide levels.,"[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Humbert', 'Affiliation': ""From the Department of Respiratory and Intensive Care Medicine, Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, INSERM Unité Mixte de Recherche 999, Université Paris-Saclay, Le Kremlin-Bicêtre, France (M.H., D.M.); the Division of Cardiovascular Medicine, Department of Internal Medicine, University of Michigan Health System, Ann Arbor (V.M.); the National Heart and Lung Institute, Imperial College London, and the National Pulmonary Hypertension Service, Hammersmith Hospital, Imperial College Healthcare NHS Trust, London (J.S.R.G.); the Department of Medicine, George Washington University, Washington, DC (M.G.-M.); the Department of Respiratory Medicine, Hannover Medical School, and the German Center for Lung Research - both in Hannover, Germany (M.M.H., K.M.O.); the Division of Pulmonary, Critical Care and Sleep Medicine, Tufts Medical Center (I.R.P.), and the Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital (A.W.), Boston, and Acceleron Pharma, Cambridge (S.M., J.B., P.G.L., J.O.P.) - all in Massachusetts; the Pulmonary Division-Heart Institute, University of São Paulo Medical School, São Paulo (R.S.), and Complexo Hospitalar Santa Casa de Porto Alegre, Pulmonary Vascular Research Institute, Porto Alegre (G.M.) - both in Brazil; the Department of Cardiology, Centro de Investigación en Red en Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, Universidad Complutense, Madrid (P.E.S.); Arizona Pulmonary Specialists, Phoenix (J.F.); and the Divisions of Pulmonary Sciences and Critical Care Medicine, and Cardiology, University of Colorado, Anschutz Medical Campus, Aurora (D.B.B.).""}, {'ForeName': 'Vallerie', 'Initials': 'V', 'LastName': 'McLaughlin', 'Affiliation': ""From the Department of Respiratory and Intensive Care Medicine, Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, INSERM Unité Mixte de Recherche 999, Université Paris-Saclay, Le Kremlin-Bicêtre, France (M.H., D.M.); the Division of Cardiovascular Medicine, Department of Internal Medicine, University of Michigan Health System, Ann Arbor (V.M.); the National Heart and Lung Institute, Imperial College London, and the National Pulmonary Hypertension Service, Hammersmith Hospital, Imperial College Healthcare NHS Trust, London (J.S.R.G.); the Department of Medicine, George Washington University, Washington, DC (M.G.-M.); the Department of Respiratory Medicine, Hannover Medical School, and the German Center for Lung Research - both in Hannover, Germany (M.M.H., K.M.O.); the Division of Pulmonary, Critical Care and Sleep Medicine, Tufts Medical Center (I.R.P.), and the Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital (A.W.), Boston, and Acceleron Pharma, Cambridge (S.M., J.B., P.G.L., J.O.P.) - all in Massachusetts; the Pulmonary Division-Heart Institute, University of São Paulo Medical School, São Paulo (R.S.), and Complexo Hospitalar Santa Casa de Porto Alegre, Pulmonary Vascular Research Institute, Porto Alegre (G.M.) - both in Brazil; the Department of Cardiology, Centro de Investigación en Red en Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, Universidad Complutense, Madrid (P.E.S.); Arizona Pulmonary Specialists, Phoenix (J.F.); and the Divisions of Pulmonary Sciences and Critical Care Medicine, and Cardiology, University of Colorado, Anschutz Medical Campus, Aurora (D.B.B.).""}, {'ForeName': 'J Simon R', 'Initials': 'JSR', 'LastName': 'Gibbs', 'Affiliation': ""From the Department of Respiratory and Intensive Care Medicine, Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, INSERM Unité Mixte de Recherche 999, Université Paris-Saclay, Le Kremlin-Bicêtre, France (M.H., D.M.); the Division of Cardiovascular Medicine, Department of Internal Medicine, University of Michigan Health System, Ann Arbor (V.M.); the National Heart and Lung Institute, Imperial College London, and the National Pulmonary Hypertension Service, Hammersmith Hospital, Imperial College Healthcare NHS Trust, London (J.S.R.G.); the Department of Medicine, George Washington University, Washington, DC (M.G.-M.); the Department of Respiratory Medicine, Hannover Medical School, and the German Center for Lung Research - both in Hannover, Germany (M.M.H., K.M.O.); the Division of Pulmonary, Critical Care and Sleep Medicine, Tufts Medical Center (I.R.P.), and the Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital (A.W.), Boston, and Acceleron Pharma, Cambridge (S.M., J.B., P.G.L., J.O.P.) - all in Massachusetts; the Pulmonary Division-Heart Institute, University of São Paulo Medical School, São Paulo (R.S.), and Complexo Hospitalar Santa Casa de Porto Alegre, Pulmonary Vascular Research Institute, Porto Alegre (G.M.) - both in Brazil; the Department of Cardiology, Centro de Investigación en Red en Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, Universidad Complutense, Madrid (P.E.S.); Arizona Pulmonary Specialists, Phoenix (J.F.); and the Divisions of Pulmonary Sciences and Critical Care Medicine, and Cardiology, University of Colorado, Anschutz Medical Campus, Aurora (D.B.B.).""}, {'ForeName': 'Mardi', 'Initials': 'M', 'LastName': 'Gomberg-Maitland', 'Affiliation': ""From the Department of Respiratory and Intensive Care Medicine, Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, INSERM Unité Mixte de Recherche 999, Université Paris-Saclay, Le Kremlin-Bicêtre, France (M.H., D.M.); the Division of Cardiovascular Medicine, Department of Internal Medicine, University of Michigan Health System, Ann Arbor (V.M.); the National Heart and Lung Institute, Imperial College London, and the National Pulmonary Hypertension Service, Hammersmith Hospital, Imperial College Healthcare NHS Trust, London (J.S.R.G.); the Department of Medicine, George Washington University, Washington, DC (M.G.-M.); the Department of Respiratory Medicine, Hannover Medical School, and the German Center for Lung Research - both in Hannover, Germany (M.M.H., K.M.O.); the Division of Pulmonary, Critical Care and Sleep Medicine, Tufts Medical Center (I.R.P.), and the Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital (A.W.), Boston, and Acceleron Pharma, Cambridge (S.M., J.B., P.G.L., J.O.P.) - all in Massachusetts; the Pulmonary Division-Heart Institute, University of São Paulo Medical School, São Paulo (R.S.), and Complexo Hospitalar Santa Casa de Porto Alegre, Pulmonary Vascular Research Institute, Porto Alegre (G.M.) - both in Brazil; the Department of Cardiology, Centro de Investigación en Red en Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, Universidad Complutense, Madrid (P.E.S.); Arizona Pulmonary Specialists, Phoenix (J.F.); and the Divisions of Pulmonary Sciences and Critical Care Medicine, and Cardiology, University of Colorado, Anschutz Medical Campus, Aurora (D.B.B.).""}, {'ForeName': 'Marius M', 'Initials': 'MM', 'LastName': 'Hoeper', 'Affiliation': ""From the Department of Respiratory and Intensive Care Medicine, Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, INSERM Unité Mixte de Recherche 999, Université Paris-Saclay, Le Kremlin-Bicêtre, France (M.H., D.M.); the Division of Cardiovascular Medicine, Department of Internal Medicine, University of Michigan Health System, Ann Arbor (V.M.); the National Heart and Lung Institute, Imperial College London, and the National Pulmonary Hypertension Service, Hammersmith Hospital, Imperial College Healthcare NHS Trust, London (J.S.R.G.); the Department of Medicine, George Washington University, Washington, DC (M.G.-M.); the Department of Respiratory Medicine, Hannover Medical School, and the German Center for Lung Research - both in Hannover, Germany (M.M.H., K.M.O.); the Division of Pulmonary, Critical Care and Sleep Medicine, Tufts Medical Center (I.R.P.), and the Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital (A.W.), Boston, and Acceleron Pharma, Cambridge (S.M., J.B., P.G.L., J.O.P.) - all in Massachusetts; the Pulmonary Division-Heart Institute, University of São Paulo Medical School, São Paulo (R.S.), and Complexo Hospitalar Santa Casa de Porto Alegre, Pulmonary Vascular Research Institute, Porto Alegre (G.M.) - both in Brazil; the Department of Cardiology, Centro de Investigación en Red en Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, Universidad Complutense, Madrid (P.E.S.); Arizona Pulmonary Specialists, Phoenix (J.F.); and the Divisions of Pulmonary Sciences and Critical Care Medicine, and Cardiology, University of Colorado, Anschutz Medical Campus, Aurora (D.B.B.).""}, {'ForeName': 'Ioana R', 'Initials': 'IR', 'LastName': 'Preston', 'Affiliation': ""From the Department of Respiratory and Intensive Care Medicine, Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, INSERM Unité Mixte de Recherche 999, Université Paris-Saclay, Le Kremlin-Bicêtre, France (M.H., D.M.); the Division of Cardiovascular Medicine, Department of Internal Medicine, University of Michigan Health System, Ann Arbor (V.M.); the National Heart and Lung Institute, Imperial College London, and the National Pulmonary Hypertension Service, Hammersmith Hospital, Imperial College Healthcare NHS Trust, London (J.S.R.G.); the Department of Medicine, George Washington University, Washington, DC (M.G.-M.); the Department of Respiratory Medicine, Hannover Medical School, and the German Center for Lung Research - both in Hannover, Germany (M.M.H., K.M.O.); the Division of Pulmonary, Critical Care and Sleep Medicine, Tufts Medical Center (I.R.P.), and the Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital (A.W.), Boston, and Acceleron Pharma, Cambridge (S.M., J.B., P.G.L., J.O.P.) - all in Massachusetts; the Pulmonary Division-Heart Institute, University of São Paulo Medical School, São Paulo (R.S.), and Complexo Hospitalar Santa Casa de Porto Alegre, Pulmonary Vascular Research Institute, Porto Alegre (G.M.) - both in Brazil; the Department of Cardiology, Centro de Investigación en Red en Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, Universidad Complutense, Madrid (P.E.S.); Arizona Pulmonary Specialists, Phoenix (J.F.); and the Divisions of Pulmonary Sciences and Critical Care Medicine, and Cardiology, University of Colorado, Anschutz Medical Campus, Aurora (D.B.B.).""}, {'ForeName': 'Rogerio', 'Initials': 'R', 'LastName': 'Souza', 'Affiliation': ""From the Department of Respiratory and Intensive Care Medicine, Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, INSERM Unité Mixte de Recherche 999, Université Paris-Saclay, Le Kremlin-Bicêtre, France (M.H., D.M.); the Division of Cardiovascular Medicine, Department of Internal Medicine, University of Michigan Health System, Ann Arbor (V.M.); the National Heart and Lung Institute, Imperial College London, and the National Pulmonary Hypertension Service, Hammersmith Hospital, Imperial College Healthcare NHS Trust, London (J.S.R.G.); the Department of Medicine, George Washington University, Washington, DC (M.G.-M.); the Department of Respiratory Medicine, Hannover Medical School, and the German Center for Lung Research - both in Hannover, Germany (M.M.H., K.M.O.); the Division of Pulmonary, Critical Care and Sleep Medicine, Tufts Medical Center (I.R.P.), and the Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital (A.W.), Boston, and Acceleron Pharma, Cambridge (S.M., J.B., P.G.L., J.O.P.) - all in Massachusetts; the Pulmonary Division-Heart Institute, University of São Paulo Medical School, São Paulo (R.S.), and Complexo Hospitalar Santa Casa de Porto Alegre, Pulmonary Vascular Research Institute, Porto Alegre (G.M.) - both in Brazil; the Department of Cardiology, Centro de Investigación en Red en Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, Universidad Complutense, Madrid (P.E.S.); Arizona Pulmonary Specialists, Phoenix (J.F.); and the Divisions of Pulmonary Sciences and Critical Care Medicine, and Cardiology, University of Colorado, Anschutz Medical Campus, Aurora (D.B.B.).""}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Waxman', 'Affiliation': ""From the Department of Respiratory and Intensive Care Medicine, Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, INSERM Unité Mixte de Recherche 999, Université Paris-Saclay, Le Kremlin-Bicêtre, France (M.H., D.M.); the Division of Cardiovascular Medicine, Department of Internal Medicine, University of Michigan Health System, Ann Arbor (V.M.); the National Heart and Lung Institute, Imperial College London, and the National Pulmonary Hypertension Service, Hammersmith Hospital, Imperial College Healthcare NHS Trust, London (J.S.R.G.); the Department of Medicine, George Washington University, Washington, DC (M.G.-M.); the Department of Respiratory Medicine, Hannover Medical School, and the German Center for Lung Research - both in Hannover, Germany (M.M.H., K.M.O.); the Division of Pulmonary, Critical Care and Sleep Medicine, Tufts Medical Center (I.R.P.), and the Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital (A.W.), Boston, and Acceleron Pharma, Cambridge (S.M., J.B., P.G.L., J.O.P.) - all in Massachusetts; the Pulmonary Division-Heart Institute, University of São Paulo Medical School, São Paulo (R.S.), and Complexo Hospitalar Santa Casa de Porto Alegre, Pulmonary Vascular Research Institute, Porto Alegre (G.M.) - both in Brazil; the Department of Cardiology, Centro de Investigación en Red en Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, Universidad Complutense, Madrid (P.E.S.); Arizona Pulmonary Specialists, Phoenix (J.F.); and the Divisions of Pulmonary Sciences and Critical Care Medicine, and Cardiology, University of Colorado, Anschutz Medical Campus, Aurora (D.B.B.).""}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Escribano Subias', 'Affiliation': ""From the Department of Respiratory and Intensive Care Medicine, Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, INSERM Unité Mixte de Recherche 999, Université Paris-Saclay, Le Kremlin-Bicêtre, France (M.H., D.M.); the Division of Cardiovascular Medicine, Department of Internal Medicine, University of Michigan Health System, Ann Arbor (V.M.); the National Heart and Lung Institute, Imperial College London, and the National Pulmonary Hypertension Service, Hammersmith Hospital, Imperial College Healthcare NHS Trust, London (J.S.R.G.); the Department of Medicine, George Washington University, Washington, DC (M.G.-M.); the Department of Respiratory Medicine, Hannover Medical School, and the German Center for Lung Research - both in Hannover, Germany (M.M.H., K.M.O.); the Division of Pulmonary, Critical Care and Sleep Medicine, Tufts Medical Center (I.R.P.), and the Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital (A.W.), Boston, and Acceleron Pharma, Cambridge (S.M., J.B., P.G.L., J.O.P.) - all in Massachusetts; the Pulmonary Division-Heart Institute, University of São Paulo Medical School, São Paulo (R.S.), and Complexo Hospitalar Santa Casa de Porto Alegre, Pulmonary Vascular Research Institute, Porto Alegre (G.M.) - both in Brazil; the Department of Cardiology, Centro de Investigación en Red en Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, Universidad Complutense, Madrid (P.E.S.); Arizona Pulmonary Specialists, Phoenix (J.F.); and the Divisions of Pulmonary Sciences and Critical Care Medicine, and Cardiology, University of Colorado, Anschutz Medical Campus, Aurora (D.B.B.).""}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Feldman', 'Affiliation': ""From the Department of Respiratory and Intensive Care Medicine, Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, INSERM Unité Mixte de Recherche 999, Université Paris-Saclay, Le Kremlin-Bicêtre, France (M.H., D.M.); the Division of Cardiovascular Medicine, Department of Internal Medicine, University of Michigan Health System, Ann Arbor (V.M.); the National Heart and Lung Institute, Imperial College London, and the National Pulmonary Hypertension Service, Hammersmith Hospital, Imperial College Healthcare NHS Trust, London (J.S.R.G.); the Department of Medicine, George Washington University, Washington, DC (M.G.-M.); the Department of Respiratory Medicine, Hannover Medical School, and the German Center for Lung Research - both in Hannover, Germany (M.M.H., K.M.O.); the Division of Pulmonary, Critical Care and Sleep Medicine, Tufts Medical Center (I.R.P.), and the Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital (A.W.), Boston, and Acceleron Pharma, Cambridge (S.M., J.B., P.G.L., J.O.P.) - all in Massachusetts; the Pulmonary Division-Heart Institute, University of São Paulo Medical School, São Paulo (R.S.), and Complexo Hospitalar Santa Casa de Porto Alegre, Pulmonary Vascular Research Institute, Porto Alegre (G.M.) - both in Brazil; the Department of Cardiology, Centro de Investigación en Red en Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, Universidad Complutense, Madrid (P.E.S.); Arizona Pulmonary Specialists, Phoenix (J.F.); and the Divisions of Pulmonary Sciences and Critical Care Medicine, and Cardiology, University of Colorado, Anschutz Medical Campus, Aurora (D.B.B.).""}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Meyer', 'Affiliation': ""From the Department of Respiratory and Intensive Care Medicine, Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, INSERM Unité Mixte de Recherche 999, Université Paris-Saclay, Le Kremlin-Bicêtre, France (M.H., D.M.); the Division of Cardiovascular Medicine, Department of Internal Medicine, University of Michigan Health System, Ann Arbor (V.M.); the National Heart and Lung Institute, Imperial College London, and the National Pulmonary Hypertension Service, Hammersmith Hospital, Imperial College Healthcare NHS Trust, London (J.S.R.G.); the Department of Medicine, George Washington University, Washington, DC (M.G.-M.); the Department of Respiratory Medicine, Hannover Medical School, and the German Center for Lung Research - both in Hannover, Germany (M.M.H., K.M.O.); the Division of Pulmonary, Critical Care and Sleep Medicine, Tufts Medical Center (I.R.P.), and the Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital (A.W.), Boston, and Acceleron Pharma, Cambridge (S.M., J.B., P.G.L., J.O.P.) - all in Massachusetts; the Pulmonary Division-Heart Institute, University of São Paulo Medical School, São Paulo (R.S.), and Complexo Hospitalar Santa Casa de Porto Alegre, Pulmonary Vascular Research Institute, Porto Alegre (G.M.) - both in Brazil; the Department of Cardiology, Centro de Investigación en Red en Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, Universidad Complutense, Madrid (P.E.S.); Arizona Pulmonary Specialists, Phoenix (J.F.); and the Divisions of Pulmonary Sciences and Critical Care Medicine, and Cardiology, University of Colorado, Anschutz Medical Campus, Aurora (D.B.B.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Montani', 'Affiliation': ""From the Department of Respiratory and Intensive Care Medicine, Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, INSERM Unité Mixte de Recherche 999, Université Paris-Saclay, Le Kremlin-Bicêtre, France (M.H., D.M.); the Division of Cardiovascular Medicine, Department of Internal Medicine, University of Michigan Health System, Ann Arbor (V.M.); the National Heart and Lung Institute, Imperial College London, and the National Pulmonary Hypertension Service, Hammersmith Hospital, Imperial College Healthcare NHS Trust, London (J.S.R.G.); the Department of Medicine, George Washington University, Washington, DC (M.G.-M.); the Department of Respiratory Medicine, Hannover Medical School, and the German Center for Lung Research - both in Hannover, Germany (M.M.H., K.M.O.); the Division of Pulmonary, Critical Care and Sleep Medicine, Tufts Medical Center (I.R.P.), and the Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital (A.W.), Boston, and Acceleron Pharma, Cambridge (S.M., J.B., P.G.L., J.O.P.) - all in Massachusetts; the Pulmonary Division-Heart Institute, University of São Paulo Medical School, São Paulo (R.S.), and Complexo Hospitalar Santa Casa de Porto Alegre, Pulmonary Vascular Research Institute, Porto Alegre (G.M.) - both in Brazil; the Department of Cardiology, Centro de Investigación en Red en Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, Universidad Complutense, Madrid (P.E.S.); Arizona Pulmonary Specialists, Phoenix (J.F.); and the Divisions of Pulmonary Sciences and Critical Care Medicine, and Cardiology, University of Colorado, Anschutz Medical Campus, Aurora (D.B.B.).""}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Olsson', 'Affiliation': ""From the Department of Respiratory and Intensive Care Medicine, Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, INSERM Unité Mixte de Recherche 999, Université Paris-Saclay, Le Kremlin-Bicêtre, France (M.H., D.M.); the Division of Cardiovascular Medicine, Department of Internal Medicine, University of Michigan Health System, Ann Arbor (V.M.); the National Heart and Lung Institute, Imperial College London, and the National Pulmonary Hypertension Service, Hammersmith Hospital, Imperial College Healthcare NHS Trust, London (J.S.R.G.); the Department of Medicine, George Washington University, Washington, DC (M.G.-M.); the Department of Respiratory Medicine, Hannover Medical School, and the German Center for Lung Research - both in Hannover, Germany (M.M.H., K.M.O.); the Division of Pulmonary, Critical Care and Sleep Medicine, Tufts Medical Center (I.R.P.), and the Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital (A.W.), Boston, and Acceleron Pharma, Cambridge (S.M., J.B., P.G.L., J.O.P.) - all in Massachusetts; the Pulmonary Division-Heart Institute, University of São Paulo Medical School, São Paulo (R.S.), and Complexo Hospitalar Santa Casa de Porto Alegre, Pulmonary Vascular Research Institute, Porto Alegre (G.M.) - both in Brazil; the Department of Cardiology, Centro de Investigación en Red en Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, Universidad Complutense, Madrid (P.E.S.); Arizona Pulmonary Specialists, Phoenix (J.F.); and the Divisions of Pulmonary Sciences and Critical Care Medicine, and Cardiology, University of Colorado, Anschutz Medical Campus, Aurora (D.B.B.).""}, {'ForeName': 'Solaiappan', 'Initials': 'S', 'LastName': 'Manimaran', 'Affiliation': ""From the Department of Respiratory and Intensive Care Medicine, Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, INSERM Unité Mixte de Recherche 999, Université Paris-Saclay, Le Kremlin-Bicêtre, France (M.H., D.M.); the Division of Cardiovascular Medicine, Department of Internal Medicine, University of Michigan Health System, Ann Arbor (V.M.); the National Heart and Lung Institute, Imperial College London, and the National Pulmonary Hypertension Service, Hammersmith Hospital, Imperial College Healthcare NHS Trust, London (J.S.R.G.); the Department of Medicine, George Washington University, Washington, DC (M.G.-M.); the Department of Respiratory Medicine, Hannover Medical School, and the German Center for Lung Research - both in Hannover, Germany (M.M.H., K.M.O.); the Division of Pulmonary, Critical Care and Sleep Medicine, Tufts Medical Center (I.R.P.), and the Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital (A.W.), Boston, and Acceleron Pharma, Cambridge (S.M., J.B., P.G.L., J.O.P.) - all in Massachusetts; the Pulmonary Division-Heart Institute, University of São Paulo Medical School, São Paulo (R.S.), and Complexo Hospitalar Santa Casa de Porto Alegre, Pulmonary Vascular Research Institute, Porto Alegre (G.M.) - both in Brazil; the Department of Cardiology, Centro de Investigación en Red en Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, Universidad Complutense, Madrid (P.E.S.); Arizona Pulmonary Specialists, Phoenix (J.F.); and the Divisions of Pulmonary Sciences and Critical Care Medicine, and Cardiology, University of Colorado, Anschutz Medical Campus, Aurora (D.B.B.).""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Barnes', 'Affiliation': ""From the Department of Respiratory and Intensive Care Medicine, Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, INSERM Unité Mixte de Recherche 999, Université Paris-Saclay, Le Kremlin-Bicêtre, France (M.H., D.M.); the Division of Cardiovascular Medicine, Department of Internal Medicine, University of Michigan Health System, Ann Arbor (V.M.); the National Heart and Lung Institute, Imperial College London, and the National Pulmonary Hypertension Service, Hammersmith Hospital, Imperial College Healthcare NHS Trust, London (J.S.R.G.); the Department of Medicine, George Washington University, Washington, DC (M.G.-M.); the Department of Respiratory Medicine, Hannover Medical School, and the German Center for Lung Research - both in Hannover, Germany (M.M.H., K.M.O.); the Division of Pulmonary, Critical Care and Sleep Medicine, Tufts Medical Center (I.R.P.), and the Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital (A.W.), Boston, and Acceleron Pharma, Cambridge (S.M., J.B., P.G.L., J.O.P.) - all in Massachusetts; the Pulmonary Division-Heart Institute, University of São Paulo Medical School, São Paulo (R.S.), and Complexo Hospitalar Santa Casa de Porto Alegre, Pulmonary Vascular Research Institute, Porto Alegre (G.M.) - both in Brazil; the Department of Cardiology, Centro de Investigación en Red en Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, Universidad Complutense, Madrid (P.E.S.); Arizona Pulmonary Specialists, Phoenix (J.F.); and the Divisions of Pulmonary Sciences and Critical Care Medicine, and Cardiology, University of Colorado, Anschutz Medical Campus, Aurora (D.B.B.).""}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Linde', 'Affiliation': ""From the Department of Respiratory and Intensive Care Medicine, Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, INSERM Unité Mixte de Recherche 999, Université Paris-Saclay, Le Kremlin-Bicêtre, France (M.H., D.M.); the Division of Cardiovascular Medicine, Department of Internal Medicine, University of Michigan Health System, Ann Arbor (V.M.); the National Heart and Lung Institute, Imperial College London, and the National Pulmonary Hypertension Service, Hammersmith Hospital, Imperial College Healthcare NHS Trust, London (J.S.R.G.); the Department of Medicine, George Washington University, Washington, DC (M.G.-M.); the Department of Respiratory Medicine, Hannover Medical School, and the German Center for Lung Research - both in Hannover, Germany (M.M.H., K.M.O.); the Division of Pulmonary, Critical Care and Sleep Medicine, Tufts Medical Center (I.R.P.), and the Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital (A.W.), Boston, and Acceleron Pharma, Cambridge (S.M., J.B., P.G.L., J.O.P.) - all in Massachusetts; the Pulmonary Division-Heart Institute, University of São Paulo Medical School, São Paulo (R.S.), and Complexo Hospitalar Santa Casa de Porto Alegre, Pulmonary Vascular Research Institute, Porto Alegre (G.M.) - both in Brazil; the Department of Cardiology, Centro de Investigación en Red en Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, Universidad Complutense, Madrid (P.E.S.); Arizona Pulmonary Specialists, Phoenix (J.F.); and the Divisions of Pulmonary Sciences and Critical Care Medicine, and Cardiology, University of Colorado, Anschutz Medical Campus, Aurora (D.B.B.).""}, {'ForeName': 'Janethe', 'Initials': 'J', 'LastName': 'de Oliveira Pena', 'Affiliation': ""From the Department of Respiratory and Intensive Care Medicine, Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, INSERM Unité Mixte de Recherche 999, Université Paris-Saclay, Le Kremlin-Bicêtre, France (M.H., D.M.); the Division of Cardiovascular Medicine, Department of Internal Medicine, University of Michigan Health System, Ann Arbor (V.M.); the National Heart and Lung Institute, Imperial College London, and the National Pulmonary Hypertension Service, Hammersmith Hospital, Imperial College Healthcare NHS Trust, London (J.S.R.G.); the Department of Medicine, George Washington University, Washington, DC (M.G.-M.); the Department of Respiratory Medicine, Hannover Medical School, and the German Center for Lung Research - both in Hannover, Germany (M.M.H., K.M.O.); the Division of Pulmonary, Critical Care and Sleep Medicine, Tufts Medical Center (I.R.P.), and the Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital (A.W.), Boston, and Acceleron Pharma, Cambridge (S.M., J.B., P.G.L., J.O.P.) - all in Massachusetts; the Pulmonary Division-Heart Institute, University of São Paulo Medical School, São Paulo (R.S.), and Complexo Hospitalar Santa Casa de Porto Alegre, Pulmonary Vascular Research Institute, Porto Alegre (G.M.) - both in Brazil; the Department of Cardiology, Centro de Investigación en Red en Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, Universidad Complutense, Madrid (P.E.S.); Arizona Pulmonary Specialists, Phoenix (J.F.); and the Divisions of Pulmonary Sciences and Critical Care Medicine, and Cardiology, University of Colorado, Anschutz Medical Campus, Aurora (D.B.B.).""}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Badesch', 'Affiliation': ""From the Department of Respiratory and Intensive Care Medicine, Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, INSERM Unité Mixte de Recherche 999, Université Paris-Saclay, Le Kremlin-Bicêtre, France (M.H., D.M.); the Division of Cardiovascular Medicine, Department of Internal Medicine, University of Michigan Health System, Ann Arbor (V.M.); the National Heart and Lung Institute, Imperial College London, and the National Pulmonary Hypertension Service, Hammersmith Hospital, Imperial College Healthcare NHS Trust, London (J.S.R.G.); the Department of Medicine, George Washington University, Washington, DC (M.G.-M.); the Department of Respiratory Medicine, Hannover Medical School, and the German Center for Lung Research - both in Hannover, Germany (M.M.H., K.M.O.); the Division of Pulmonary, Critical Care and Sleep Medicine, Tufts Medical Center (I.R.P.), and the Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital (A.W.), Boston, and Acceleron Pharma, Cambridge (S.M., J.B., P.G.L., J.O.P.) - all in Massachusetts; the Pulmonary Division-Heart Institute, University of São Paulo Medical School, São Paulo (R.S.), and Complexo Hospitalar Santa Casa de Porto Alegre, Pulmonary Vascular Research Institute, Porto Alegre (G.M.) - both in Brazil; the Department of Cardiology, Centro de Investigación en Red en Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, Universidad Complutense, Madrid (P.E.S.); Arizona Pulmonary Specialists, Phoenix (J.F.); and the Divisions of Pulmonary Sciences and Critical Care Medicine, and Cardiology, University of Colorado, Anschutz Medical Campus, Aurora (D.B.B.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2024277'] 2862,33814890,"Energy Expenditure, Cardiorespiratory Fitness, and Body Composition Following Arm Cycling or Functional Electrical Stimulation Exercises in Spinal Cord Injury: A 16-Week Randomized Controlled Trial.","Background: Physical deconditioning and inactivity following spinal cord injury (SCI) are associated with multiple cardiometabolic risks. To mitigate cardiometabolic risk, exercise is recommended, but it is poorly established whether arm cycling exercise (ACE) or functional electrical stimulation (FES) leg cycling yields superior benefits. Objectives: To determine the adaptations of 16 weeks of FES cycling and ACE on exercise energy expenditure (EEE), cardiorespiratory fitness (CRF), and obesity after SCI. Methods: Thirteen physically untrained individuals were randomly assigned to FES ( n = 6) or ACE ( n = 7) exercise 5 days/week for 16 weeks. Pre- and post-intervention EEE, peak oxygen consumption (absolute and relative VO 2Peak ), and work were assessed using indirect calorimetry, while body composition was measured by dual-energy x-ray absorptiometry. Results: Main effects were found for peak power ( p < .001), absolute ( p = .046) and relative ( p = .042) VO 2Peak , and peak work ( p = .013). Compared to baseline, the ACE group increased in EEE (+85%, p = .002), peak power (+307%, p < .001), VO 2Peak (absolute +21%, relative +22%, p ≤ .024), peak work (19% increase, p = .003), and total body fat decreased (-6%, p = .05). The FES group showed a decrease in percentage body fat mass (-5%, p = .008). The ACE group had higher EEE ( p = .008), peak power ( p < .001), and relative VO 2Peak ( p = .025) compared to postintervention values in the FES group. Conclusion: In the current study, ACE induced greater increases in EEE and CRF, whereas ACE and FES showed similar results on body fat. Exercise promotional efforts targeting persons with SCI should use both FES and ACE to reduce sedentary behavior and to optimize different health parameters after SCI.",2021,"The ACE group had higher EEE ( p = .008), peak power ( p < .001), and relative VO 2Peak ( p = .025) compared to postintervention values in the FES group. ","['persons with SCI', 'Spinal Cord Injury', 'Thirteen physically untrained individuals']","['ACE', 'Pre- and post-intervention EEE', 'FES and ACE', 'FES', 'Arm Cycling or Functional Electrical Stimulation Exercises', 'FES cycling and ACE']","['peak power', 'exercise energy expenditure (EEE), cardiorespiratory fitness (CRF), and obesity after SCI', 'peak work', 'EEE', 'Energy Expenditure, Cardiorespiratory Fitness, and Body Composition', 'VO 2Peak', 'total body fat', 'higher EEE', 'VO 2Peak , and peak work', 'EEE and CRF', ' peak oxygen consumption (absolute and relative VO 2Peak ), and work were assessed using indirect calorimetry, while body composition', 'percentage body fat mass', 'relative VO 2Peak', 'body fat']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C3715149', 'cui_str': '13'}]","[{'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0153065', 'cui_str': 'Eastern equine encephalitis virus infection'}, {'cui': 'C0525959', 'cui_str': '16-fluoroestradiol, (16alpha, 17beta)-isomer, (18F)-labeled'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0153065', 'cui_str': 'Eastern equine encephalitis virus infection'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0424677', 'cui_str': 'Total body fat'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0010132', 'cui_str': 'Corticotropin-Releasing Hormone'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0006781', 'cui_str': 'Indirect calorimetry'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",13.0,0.0200015,"The ACE group had higher EEE ( p = .008), peak power ( p < .001), and relative VO 2Peak ( p = .025) compared to postintervention values in the FES group. ","[{'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Farkas', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Ashraf S', 'Initials': 'AS', 'LastName': 'Gorgey', 'Affiliation': 'Spinal Cord Injury and Disorders Center, Hunter Holmes McGuire VA Medical Center, Richmond, Virginia.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Dolbow', 'Affiliation': 'Department of Physical Therapy, William Carey University, Hattiesburg, Mississippi.'}, {'ForeName': 'Arthur S', 'Initials': 'AS', 'LastName': 'Berg', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Gater', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Miami Miller School of Medicine, Miami, Florida.'}]",Topics in spinal cord injury rehabilitation,['10.46292/sci20-00065'] 2863,33781956,Non-invasive brain stimulation for speech in Parkinson's disease: A randomized controlled trial.,"BACKGROUND Hypokinetic dysarthria is a common but difficult-to-treat symptom of Parkinson's disease (PD). OBJECTIVES We evaluated the long-term effects of multiple-session repetitive transcranial magnetic stimulation on hypokinetic dysarthria in PD. Neural mechanisms of stimulation were assessed by functional MRI. METHODS A randomized parallel-group sham stimulation-controlled design was used. Patients were randomly assigned to ten sessions (2 weeks) of real (1 Hz) or sham stimulation over the right superior temporal gyrus. Stimulation effects were evaluated at weeks 2, 6, and 10 after the baseline assessment. Articulation, prosody, and speech intelligibility were quantified by speech therapist using a validated tool (Phonetics score of the Dysarthric Profile). Activations of the speech network regions and intrinsic connectivity were assessed using 3T MRI. Linear mixed models and post-hoc tests were utilized for data analyses. RESULTS Altogether 33 PD patients completed the study (20 in the real stimulation group and 13 in the sham stimulation group). Linear mixed models revealed significant effects of time (F(3, 88.1) = 22.7, p < 0.001) and time-by-group interactions: F(3, 88.0) = 2.8, p = 0.040) for the Phonetics score. Real as compared to sham stimulation led to activation increases in the orofacial sensorimotor cortex and caudate nucleus and to increased intrinsic connectivity of these regions with the stimulated area. CONCLUSIONS This is the first study to show the long-term treatment effects of non-invasive brain stimulation for hypokinetic dysarthria in PD. Neural mechanisms of the changes are discussed.",2021,"Real as compared to sham stimulation led to activation increases in the orofacial sensorimotor cortex and caudate nucleus and to increased intrinsic connectivity of these regions with the stimulated area. ","['hypokinetic dysarthria in PD', ""Parkinson's disease""]","['invasive brain stimulation', 'multiple-session repetitive transcranial magnetic stimulation']","['Stimulation effects', 'Articulation, prosody, and speech intelligibility']","[{'cui': 'C0454600', 'cui_str': 'Extrapyramidal dysarthria'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0233743', 'cui_str': 'Prosody'}, {'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}]",,0.137056,"Real as compared to sham stimulation led to activation increases in the orofacial sensorimotor cortex and caudate nucleus and to increased intrinsic connectivity of these regions with the stimulated area. ","[{'ForeName': 'Lubos', 'Initials': 'L', 'LastName': 'Brabenec', 'Affiliation': 'Applied Neuroscience Research Group, Central European Institute of Technology - CEITEC, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Klobusiakova', 'Affiliation': 'Applied Neuroscience Research Group, Central European Institute of Technology - CEITEC, Masaryk University, Brno, Czech Republic; Faculty of Medicine, Masaryk University, Brno, Czech Republic; Surgeon General Office of the Slovak Armed Forces, Ružomberok, Slovak Republic.'}, {'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Simko', 'Affiliation': 'Applied Neuroscience Research Group, Central European Institute of Technology - CEITEC, Masaryk University, Brno, Czech Republic; Faculty of Medicine, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Kostalova', 'Affiliation': 'Applied Neuroscience Research Group, Central European Institute of Technology - CEITEC, Masaryk University, Brno, Czech Republic; Faculty of Medicine, Masaryk University, Brno, Czech Republic; Department of Neurology, Faculty Hospital and Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Mekyska', 'Affiliation': 'Department of Telecommunications, Brno University of Technology, Brno, Czech Republic.'}, {'ForeName': 'Irena', 'Initials': 'I', 'LastName': 'Rektorova', 'Affiliation': ""Applied Neuroscience Research Group, Central European Institute of Technology - CEITEC, Masaryk University, Brno, Czech Republic; First Department of Neurology, Faculty of Medicine and St. Anne's University Hospital, Masaryk University, Brno, Czech Republic. Electronic address: irena.rektorova@fnusa.cz.""}]",Brain stimulation,['10.1016/j.brs.2021.03.010'] 2864,33780901,Comparison between the endoscopic scores of bolgerization versus partial resection of the middle turbinate for management of the postoperative lateralization in the early follow-up period after endoscopic frontal sinusotomy: A randomized controlled study.,"BACKGROUND Frontal sinusotomy is a challenging procedure that needs meticulous handling due to its unique anatomical position. Postoperative middle turbinate lateralization is critical comorbidity for the success rate, and many techniques are adopted to prevent it. The study aimed to compare the effect of middle turbinate bolgerization and partial resection on the postoperative endoscopic scores and assess their impact on the middle meatus and the frontal recess outcome. PATIENT AND METHODS This prospective study was conducted on forty-one patients undergoing bilateral frontal sinusotomy for chronic frontal sinusitis. Nasal cavities were randomized so that partial middle turbinate resection technique was done alternately with bolgerization approach in every patient. Each participant acted as their control. Both sides were compared using Lund Kennedy Endoscopic Score (LKES) and Perioperative Sinus Endoscopy Score (POSE) at the baseline, 1st, 3rd, and 12th-month intervals postoperatively. Also, middle turbinate status was assessed at the end of the 12th-month interval using POSE score. RESULTS The total frontal sinus patency rate was 82.9% (63/76 operated sinus). Baseline scores, LKES (3.79 ± 0.777 vs 4.05 ± 0.769, p = 0.142, for the side of resection and the side for bolgerization respectively) and POSE (1.79 ± 0.413 vs 1.82 ± 0.393, p = 0.777, for the side of resection and the side for bolgerization respectively). Regarding LKES, the differences between both operated sides were fluctuating with p values: 0.001*, 0.171, and 0.044* for the 1st, 3rd, and 12th months follow-up intervals, respectively. Regarding the POSE score of the frontal sinus, the difference between both groups was steadily increasing with p values: 0.318, 0.119, and 0.017* for the 1st, 3rd , and 12th months follow-up intervals. The middle turbinate's POSE score at the 12th month was significantly higher in the side allocated for bolgerization (p-value = 0.008*). CONCLUSION Partial middle turbinate resection showed favorable endoscopic outcomes than bolgerization at the 12th month follow up period in patients undergoing primary ESS for chronic frontal sinusitis.",2021,"The middle turbinate's POSE score at the 12th month was significantly higher in the side allocated for bolgerization (p-value = 0.008*). ","['patients undergoing primary ESS for chronic frontal sinusitis', 'forty-one patients undergoing bilateral frontal sinusotomy for chronic frontal sinusitis']","['Partial middle turbinate resection', 'middle turbinate bolgerization and partial resection', 'partial middle turbinate resection technique', 'bolgerization versus partial resection of the middle turbinate']","[""middle turbinate's POSE score"", 'total frontal sinus patency rate', 'postoperative endoscopic scores', 'Lund Kennedy Endoscopic Score (LKES) and Perioperative Sinus Endoscopy Score (POSE', 'middle turbinate status', 'favorable endoscopic outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0206630', 'cui_str': 'Endometrial stromal sarcoma'}, {'cui': 'C0008683', 'cui_str': 'Chronic frontal sinusitis'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0189113', 'cui_str': 'Frontal sinusotomy'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0225435', 'cui_str': 'Middle nasal turbinate structure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0225435', 'cui_str': 'Middle nasal turbinate structure'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0016734', 'cui_str': 'Frontal sinus structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",41.0,0.103473,"The middle turbinate's POSE score at the 12th month was significantly higher in the side allocated for bolgerization (p-value = 0.008*). ","[{'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Khafagy', 'Affiliation': 'Otorhinolaryngology, Faculty of Medicine, Mansoura University, Egypt. Electronic address: ykhafagy@mans.edu.eg.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Ghonim', 'Affiliation': 'Otorhinolaryngology, Faculty of Medicine, Mansoura University, Egypt.'}, {'ForeName': 'Saad', 'Initials': 'S', 'LastName': 'Elzayat', 'Affiliation': 'Otorhinolaryngology, Faculty of Medicine, Kafrelsheikh University, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elgendy', 'Affiliation': 'Otorhinolaryngology, Faculty of Medicine, Kafrelsheikh University, Egypt. Electronic address: Ahmed_Elgendy@med.kfs.edu.eg.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2021.102998'] 2865,33807135,"Plasma Free Fatty Acids and Metabolic Effect in Type 2 Diabetes, an Ancillary Study from a Randomized Clinical Trial.","Most nutrition studies looking at the association of food with cardiometabolic markers rely on food frequency questionnaires, which are prone to recall bias. Pentadecanoic acid, heptadecanoic acid and trans-palmitoleic acid are fatty acids that are not synthesized endogenously but are obtained from the diet, particularly dairy, making them reasonable biomarkers of dairy consumption. We investigated the association of dairy fatty acid biomarkers with glycated hemoglobin (HbA1c) and cardiovascular risk factors in type 2 diabetes (T2D). In a clinical trial, 111 participants with T2D (age 58.5 ± 8.9 years, HbA1c 8.09 ± 0.96%) were randomized into three groups: a control group that maintained baseline dairy intake, a low-fat (LF) group that incorporated ≥3 servings/day of LF dairy and a high-fat (HF) group that incorporated ≥3 servings/day of HF dairy. We compared the fatty acids (FA) composition between the three groups at 24 weeks. Pentadecanoic acid and trans-palmitoleic acid increased in the HF group by 14.1% ± 5.4% and 17.5% ± 5.1%, respectively, but not in the control and LF groups ( p = 0.0474 and p = 0.0025 for group-by-time interaction, respectively). Those increases were positively associated with changes in total cholesterol, very-low-density lipoprotein cholesterol VLDL-C and triglycerides but were not associated with changes in HbA1c from baseline to 24 weeks. These results suggest that the intervention was successful and that participants were likely compliant, which supports the validity of the main trial.",2021,"Pentadecanoic acid and trans-palmitoleic acid increased in the HF group by 14.1% ± 5.4% and 17.5% ± 5.1%, respectively, but not in the control and LF groups ( p = 0.0474 and ","['Type 2 Diabetes', 'type 2 diabetes (T2D', '111 participants with T2D (age 58.5 ± 8.9 years, HbA1c 8.09 ± 0.96']","['dairy fatty acid biomarkers with glycated hemoglobin (HbA1c', 'control group that maintained baseline dairy intake, a low-fat (LF) group that incorporated ≥3 servings/day of LF dairy and a high-fat (HF) group that incorporated ≥3 servings/day of HF dairy']","['fatty acids (FA) composition', 'Pentadecanoic acid and trans-palmitoleic acid', 'Plasma Free Fatty Acids and Metabolic Effect', 'total cholesterol, very-low-density lipoprotein cholesterol VLDL-C and triglycerides']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0762868', 'cui_str': 'pentadecanoic acid'}, {'cui': 'C0069966', 'cui_str': 'Palmitoleic acid'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023826', 'cui_str': 'VLDL cholesterol'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",111.0,0.163485,"Pentadecanoic acid and trans-palmitoleic acid increased in the HF group by 14.1% ± 5.4% and 17.5% ± 5.1%, respectively, but not in the control and LF groups ( p = 0.0474 and ","[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Mitri', 'Affiliation': 'Joslin Diabetes Center, 1 Joslin Place, Boston, MA 02215, USA.'}, {'ForeName': 'Shaheen', 'Initials': 'S', 'LastName': 'Tomah', 'Affiliation': 'Joslin Diabetes Center, 1 Joslin Place, Boston, MA 02215, USA.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Furtado', 'Affiliation': 'Department of Nutrition, Harvard T. H. Chan School of Public Health, 665 Huntington Avenue, Boston, MA 02115, USA.'}, {'ForeName': 'Mhd Wael', 'Initials': 'MW', 'LastName': 'Tasabehji', 'Affiliation': 'Joslin Diabetes Center, 1 Joslin Place, Boston, MA 02215, USA.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Hamdy', 'Affiliation': 'Joslin Diabetes Center, 1 Joslin Place, Boston, MA 02215, USA.'}]",Nutrients,['10.3390/nu13041145'] 2866,33807102,"The Effects of Time-Restricted Eating versus Standard Dietary Advice on Weight, Metabolic Health and the Consumption of Processed Food: A Pragmatic Randomised Controlled Trial in Community-Based Adults.","Weight loss is key to controlling the increasing prevalence of metabolic syndrome (MS) and its components, i.e., central obesity, hypertension, prediabetes and dyslipidaemia. The goals of our study were two-fold. First, we characterised the relationships between eating duration, unprocessed and processed food consumption and metabolic health. During 4 weeks of observation, 213 adults used a smartphone application to record food and drink consumption, which was annotated for food processing levels following the NOVA classification. Low consumption of unprocessed food and low physical activity showed significant associations with multiple MS components. Second, in a pragmatic randomised controlled trial, we compared the metabolic benefits of 12 h time-restricted eating (TRE) to standard dietary advice (SDA) in 54 adults with an eating duration > 14 h and at least one MS component. After 6 months, those randomised to TRE lost 1.6% of initial body weight (SD 2.9, p = 0.01), compared to the absence of weight loss with SDA (-1.1%, SD 3.5, p = 0.19). There was no significant difference in weight loss between TRE and SDA (between-group difference -0.88%, 95% confidence interval -3.1 to 1.3, p = 0.43). Our results show the potential of smartphone records to predict metabolic health and highlight that further research is needed to improve individual responses to TRE such as a shorter eating window or its actual clock time.",2021,"There was no significant difference in weight loss between TRE and SDA (between-group difference -0.88%, 95% confidence interval -3.1 to 1.3, p = 0.43).","['213 adults used a', 'Community-Based Adults', '54 adults with an eating duration > 14 h and at least one MS component']","['smartphone application to record food and drink consumption', '12 h time-restricted eating (TRE) to standard dietary advice (SDA', 'Time-Restricted Eating versus Standard Dietary Advice']","['weight loss with SDA', 'Weight loss', 'weight loss between TRE and SDA']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0524819', 'cui_str': 'Foods and drinks'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}]",54.0,0.0814309,"There was no significant difference in weight loss between TRE and SDA (between-group difference -0.88%, 95% confidence interval -3.1 to 1.3, p = 0.43).","[{'ForeName': 'Nicholas Edward', 'Initials': 'NE', 'LastName': 'Phillips', 'Affiliation': 'Institute of Bioengineering, School of Life Sciences, Ecole Polytechnique Fédérale de Lausanne (EPFL), 1015 Lausanne, Switzerland.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Mareschal', 'Affiliation': 'Service of Endocrinology, Diabetes, Nutrition and Therapeutic Education, Department of Medicine, Geneva University Hospitals (HUG), 1211 Geneva, Switzerland.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Schwab', 'Affiliation': 'Service of Endocrinology, Diabetes and Metabolism, Department of Medicine, Lausanne University Hospital (CHUV) and University of Lausanne, 1011 Lausanne, Switzerland.'}, {'ForeName': 'Emily N C', 'Initials': 'ENC', 'LastName': 'Manoogian', 'Affiliation': 'Salk Institute for Biological Sciences, La Jolla, CA 92037, USA.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Borloz', 'Affiliation': 'Service of Paediatrics, Department Woman-Mother-Child, Lausanne University Hospital (CHUV) and University of Lausanne, 1011 Lausanne, Switzerland.'}, {'ForeName': 'Giada', 'Initials': 'G', 'LastName': 'Ostinelli', 'Affiliation': 'Service of Endocrinology, Diabetes and Metabolism, Department of Medicine, Lausanne University Hospital (CHUV) and University of Lausanne, 1011 Lausanne, Switzerland.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Gauthier-Jaques', 'Affiliation': 'Service of Endocrinology, Diabetes and Metabolism, Department of Medicine, Lausanne University Hospital (CHUV) and University of Lausanne, 1011 Lausanne, Switzerland.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Umwali', 'Affiliation': 'Service of Endocrinology, Diabetes and Metabolism, Department of Medicine, Lausanne University Hospital (CHUV) and University of Lausanne, 1011 Lausanne, Switzerland.'}, {'ForeName': 'Elena Gonzalez', 'Initials': 'EG', 'LastName': 'Rodriguez', 'Affiliation': 'Interdisciplinary Center for Bone Diseases, Service of Rheumatology, Lausanne University Hospital (CHUV) and University of Lausanne, 1011 Lausanne, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Aeberli', 'Affiliation': 'Department of Rheumatology and Immunology, Bern University Hospital, Inselspital and University of Bern, 3010 Bern, Switzerland.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Hans', 'Affiliation': 'Interdisciplinary Center for Bone Diseases, Service of Rheumatology, Lausanne University Hospital (CHUV) and University of Lausanne, 1011 Lausanne, Switzerland.'}, {'ForeName': 'Satchidananda', 'Initials': 'S', 'LastName': 'Panda', 'Affiliation': 'Salk Institute for Biological Sciences, La Jolla, CA 92037, USA.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rodondi', 'Affiliation': 'Department of General Internal Medicine, Bern University Hospital, Inselspital, University of Bern, 3010 Bern, Switzerland.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Naef', 'Affiliation': 'Institute of Bioengineering, School of Life Sciences, Ecole Polytechnique Fédérale de Lausanne (EPFL), 1015 Lausanne, Switzerland.'}, {'ForeName': 'Tinh-Hai', 'Initials': 'TH', 'LastName': 'Collet', 'Affiliation': 'Service of Endocrinology, Diabetes, Nutrition and Therapeutic Education, Department of Medicine, Geneva University Hospitals (HUG), 1211 Geneva, Switzerland.'}]",Nutrients,['10.3390/nu13031042'] 2867,33806508,"Effects of a Lactobacilli Probiotic on Reducing Duration of URTI and Fever, and Use of URTI-Associated Medicine: A Re-Analysis of a Randomized, Placebo-Controlled Study.","We previously reported on the effects of Lactoplantibacillus plantarum DR7 on reducing Upper Respiratory Tract Infections (URTI) symptoms' score and frequency in 109 adults upon a 12-week consumption at 10 9 colony-forming units (CFU)/day, but several limitations were detected in the publication. Thus, the present study re-analyzed some data with the aim to address some of these weaknesses, and presents new data on duration of URTI and consumption of URTI-associated medication, as compared to the placebo. Our re-analyses found probiotic administration significantly reduced the proportion of patient days of URTI and of fever (all p < 0.05). Recent history of URTI was a prevalent co-factor in affecting duration of URTI symptoms and fever, while other demographic and clinical factors had no influence. Exploratory analyses suggested probiotic had an earlier benefit in patients without a recent history of URTI compared to those with a recent history of URTI. Therefore, recent history of infections could have a modulatory effect on probiotic efficacy. Average number of months with reported use of URTI-related medication was 3.4-times lower in the probiotic group as compared to placebo ( p = 0.016) during the intervention. Taken together, our present new data further support previous findings that DR7 probiotic had a beneficial effect on URTI.",2021,Our re-analyses found probiotic administration significantly reduced the proportion of patient days of URTI and of fever (all p < 0.05).,['109 adults upon a 12-week consumption at 10 9 colony-forming units (CFU)/day'],"['Placebo', 'Lactobacilli Probiotic', 'placebo', 'Lactoplantibacillus plantarum DR7']","['Duration of URTI and Fever, and Use of URTI-Associated Medicine', 'proportion of patient days of URTI and of fever', ""Upper Respiratory Tract Infections (URTI) symptoms' score and frequency""]","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C1231534', 'cui_str': 'Curtobacterium plantarum'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",109.0,0.058347,Our re-analyses found probiotic administration significantly reduced the proportion of patient days of URTI and of fever (all p < 0.05).,"[{'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Altadill', 'Affiliation': 'AB-Biotics SA, Sant Cugat del Vallès, 08172 Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Espadaler-Mazo', 'Affiliation': 'AB-Biotics SA, Sant Cugat del Vallès, 08172 Barcelona, Spain.'}, {'ForeName': 'Min-Tze', 'Initials': 'MT', 'LastName': 'Liong', 'Affiliation': 'Department of Bioprocess Technology, School of Industrial Technology, University Sains Malaysia, Penang 11800, Malaysia.'}]",Microorganisms,['10.3390/microorganisms9030528'] 2868,33806491,Improvement of Atopic Dermatitis by Synbiotic Baths.,"Atopic dermatitis (AD) is a widespread chronic inflammatory dermatologic disorder. This randomized, double-blind study aims to evaluate the effect of synbiotic baths with a defined mixture of six viable lactic acid bacteria (LAB) and prebiotics, without bacteria and prebiotics and placebo baths without prebiotics and bacteria to treat AD patients over a period of 14 days. Therefore, AD patients were randomly assigned into three groups using synbiotic ( n = 7), prebiotics ( n = 8) or placebo baths ( n = 7). Severity of AD was evaluated over time by using severity scoring of atopic dermatitis (SCORAD) and by patient questionnaires. In addition, microbiome on eczematous skin surface was sampled by swaps from each patient before the bath treatment, and after 9, 11 and 14 days of bath treatment. Thereafter, nucleic acids were extracted and the bacterial 16S rRNA gene was amplified via PCR for subsequent amplicon sequencing. Results showed a significantly reduced SCORAD over time of AD patients after daily synbiotic or prebiotic baths. Moreover, AD patients after daily synbiotic baths had a significantly improved pruritus and skin dryness and their bacterial microbiome was enriched by LAB. Taken together, a synbiotic bath is a promising topical skin application to alleviate AD.",2021,"Moreover, AD patients after daily synbiotic baths had a significantly improved pruritus and skin dryness and their bacterial microbiome was enriched by LAB.",['Atopic dermatitis (AD'],"['synbiotic', 'synbiotic baths with a defined mixture of six viable lactic acid bacteria (LAB) and prebiotics, without bacteria and prebiotics and placebo', 'placebo']","['Atopic Dermatitis', 'eczematous skin surface', 'pruritus and skin dryness and their bacterial microbiome']","[{'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}]","[{'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C1210581', 'cui_str': 'Lactobacillales'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0151908', 'cui_str': 'Dry skin'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}]",,0.340341,"Moreover, AD patients after daily synbiotic baths had a significantly improved pruritus and skin dryness and their bacterial microbiome was enriched by LAB.","[{'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Noll', 'Affiliation': 'Institute for Bioanalysis, Department of Applied Sciences, Coburg University of Applied Sciences and Arts, 96450 Coburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Jäger', 'Affiliation': 'Institute for Bioanalysis, Department of Applied Sciences, Coburg University of Applied Sciences and Arts, 96450 Coburg, Germany.'}, {'ForeName': 'Leonie', 'Initials': 'L', 'LastName': 'Lux', 'Affiliation': 'Institute for Bioanalysis, Department of Applied Sciences, Coburg University of Applied Sciences and Arts, 96450 Coburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Buettner', 'Affiliation': 'Institute for Bioanalysis, Department of Applied Sciences, Coburg University of Applied Sciences and Arts, 96450 Coburg, Germany.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Axt-Gadermann', 'Affiliation': 'Institute for Bioanalysis, Department of Applied Sciences, Coburg University of Applied Sciences and Arts, 96450 Coburg, Germany.'}]",Microorganisms,['10.3390/microorganisms9030527'] 2869,33806416,An Emulation of Randomized Trials of Administrating Antipsychotics in PTSD Patients for Outcomes of Suicide-Related Events.,"Post-traumatic stress disorder (PTSD) is a prevalent mental disorder marked by psychological and behavioral changes. Currently, there is no consensus of preferred antipsychotics to be used for the treatment of PTSD. We aim to discover whether certain antipsychotics have decreased suicide risk in the PTSD population, as these patients may be at higher risk. A total of 38,807 patients were identified with a diagnosis of PTSD through the ICD9 or ICD10 codes from January 2004 to October 2019. An emulation of randomized clinical trials was conducted to compare the outcomes of suicide-related events (SREs) among PTSD patients who ever used one of eight individual antipsychotics after the diagnosis of PTSD. Exclusion criteria included patients with a history of SREs and a previous history of antipsychotic use within one year before enrollment. Eligible individuals were assigned to a treatment group according to the antipsychotic initiated and followed until stopping current treatment, switching to another same class of drugs, death, or loss to follow up. The primary outcome was to identify the frequency of SREs associated with each antipsychotic. SREs were defined as ideation, attempts, and death by suicide. Pooled logistic regression methods with the Firth option were conducted to compare two drugs for their outcomes using SAS version 9.4 (SAS Institute, Cary, NC, USA). The results were adjusted for baseline characteristics and post-baseline, time-varying confounders. A total of 5294 patients were eligible for enrollment with an average follow up of 7.86 months. A total of 157 SREs were recorded throughout this study. Lurasidone showed a statistically significant decrease in SREs when compared head to head to almost all the other antipsychotics: aripiprazole, haloperidol, olanzapine, quetiapine, risperidone, and ziprasidone ( p < 0.0001 and false discovery rate-adjusted p value < 0.0004). In addition, olanzapine was associated with higher SREs than quetiapine and risperidone, and ziprasidone was associated with higher SREs than risperidone. The results of this study suggest that certain antipsychotics may put individuals within the PTSD population at an increased risk of SREs, and that careful consideration may need to be taken when prescribed.",2021,"Lurasidone showed a statistically significant decrease in SREs when compared head to head to almost all the other antipsychotics: aripiprazole, haloperidol, olanzapine, quetiapine, risperidone, and ziprasidone ( p < 0.0001 and false discovery rate-adjusted p value < 0.0004).","['5294 patients were eligible for enrollment with an average follow up of 7.86 months', 'Exclusion criteria included patients with a history of SREs and a previous history of antipsychotic use within one year before enrollment', 'PTSD Patients for Outcomes of Suicide-Related Events', '38,807 patients were identified with a diagnosis of PTSD through the ICD9 or ICD10 codes from January 2004 to October 2019', 'PTSD patients who ever used one of eight individual antipsychotics after the diagnosis of PTSD']","['haloperidol, olanzapine, quetiapine, risperidone', 'olanzapine', 'ziprasidone', 'risperidone', 'quetiapine', 'antipsychotic initiated and followed until stopping current treatment, switching to another same class of drugs, death, or loss to follow up', 'Antipsychotics']","['frequency of SREs associated with each antipsychotic', 'SREs', 'suicide risk']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0380393', 'cui_str': 'ziprasidone'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0563664', 'cui_str': 'At risk for suicide'}]",38807.0,0.0403173,"Lurasidone showed a statistically significant decrease in SREs when compared head to head to almost all the other antipsychotics: aripiprazole, haloperidol, olanzapine, quetiapine, risperidone, and ziprasidone ( p < 0.0001 and false discovery rate-adjusted p value < 0.0004).","[{'ForeName': 'Noah R', 'Initials': 'NR', 'LastName': 'Delapaz', 'Affiliation': 'University of Pittsburgh School of Pharmacy, Pittsburgh, PA 15213, USA.'}, {'ForeName': 'William K', 'Initials': 'WK', 'LastName': 'Hor', 'Affiliation': 'University of Pittsburgh School of Pharmacy, Pittsburgh, PA 15213, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gilbert', 'Affiliation': 'University of Pittsburgh School of Pharmacy, Pittsburgh, PA 15213, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'La', 'Affiliation': 'University of Pittsburgh School of Pharmacy, Pittsburgh, PA 15213, USA.'}, {'ForeName': 'Feiran', 'Initials': 'F', 'LastName': 'Liang', 'Affiliation': 'University of Pittsburgh School of Pharmacy, Pittsburgh, PA 15213, USA.'}, {'ForeName': 'Peihao', 'Initials': 'P', 'LastName': 'Fan', 'Affiliation': 'Department of Pharmaceutical Sciences, Computational Chemical Genomics Screening Center, University of Pittsburgh School of Pharmacy, Pittsburgh, PA 15213, USA.'}, {'ForeName': 'Xiguang', 'Initials': 'X', 'LastName': 'Qi', 'Affiliation': 'Department of Pharmaceutical Sciences, Computational Chemical Genomics Screening Center, University of Pittsburgh School of Pharmacy, Pittsburgh, PA 15213, USA.'}, {'ForeName': 'Xiaojiang', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Department of Pharmaceutical Sciences, Computational Chemical Genomics Screening Center, University of Pittsburgh School of Pharmacy, Pittsburgh, PA 15213, USA.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Ying', 'Affiliation': 'Department of Internal Medicine, University of Utah, Salt Lake City, UT 84132, USA.'}, {'ForeName': 'Dara', 'Initials': 'D', 'LastName': 'Sakolsky', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA 15213, USA.'}, {'ForeName': 'Levent', 'Initials': 'L', 'LastName': 'Kirisci', 'Affiliation': 'Department of Pharmaceutical Sciences, University of Pittsburgh School of Pharmacy, Pittsburgh, PA 15213, USA.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Silverstein', 'Affiliation': 'Department of Biomedical Informatics, University of Pittsburgh School of Medicine, Pittsburgh, PA 15206, USA.'}, {'ForeName': 'Lirong', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Pharmaceutical Sciences, Computational Chemical Genomics Screening Center, University of Pittsburgh School of Pharmacy, Pittsburgh, PA 15213, USA.'}]",Journal of personalized medicine,['10.3390/jpm11030178'] 2870,33805975,"Biocompatibility and Effectiveness of a Novel, Organic Olive Oil-Based Denture Adhesive: A Multicenter Randomized and Placebo-Controlled Clinical Trial.","To assess the clinical efficacy of a novel, organic olive oil-based denture adhesive and its effect on Candida albicans growth in maxillary edentulous individuals wearing complete dentures, individuals were selected from two dental schools in Portugal and Spain. Twenty-eight complete dentures were relined, following a standardized protocol. The novel product (test) was compared with a commercialized adhesive (control) and Vaseline (placebo) randomly assigned in a cross-study design. The retention resistance was measured with a gnathometer and a dynamometer. The patients related outcome evaluations with a five-point questionnaire, and the Candida albicans growth in a Sabouraud dextrose agar (SDA) medium was used to evaluate differences between the placebo and experimental product. Twenty-three participants were included. The dynamometer evaluation showed significant differences between not using a denture adhesive and using either (experimental, p = 0.03; control, p = 0.04) and no significant differences between the two adhesives ( p > 0.05). In the subjective analysis, the experimental adhesive showed a significantly longer effectiveness ( p = 0.001), and the control reported better results in taste ( p = 0.03) and in chewing ( p = 0.001). The test adhesive showed better ( p < 0.001) Candida albicans growth inhibition. The experimental adhesive showed longer effectiveness than the control and the placebo with a better inhibition capacity for the growth of Candida albicans . Patients reported better abilities for speech, chewing, taste, and retirement in the control adhesive.",2021,The experimental adhesive showed longer effectiveness than the control and the placebo with a better inhibition capacity for the growth of Candida albicans .,"['maxillary edentulous individuals wearing complete dentures, individuals were selected from two dental schools in Portugal and Spain', 'Twenty-three participants were included']","['placebo', 'commercialized adhesive (control) and Vaseline (placebo', 'novel, organic olive oil-based denture adhesive', 'Novel, Organic Olive Oil-Based Denture Adhesive', 'Placebo']","['abilities for speech, chewing, taste, and retirement', 'Biocompatibility and Effectiveness', 'retention resistance']","[{'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011455', 'cui_str': 'Complete denture'}, {'cui': 'C0036376', 'cui_str': 'Dental School'}, {'cui': 'C0032729', 'cui_str': 'Portugal'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0728774', 'cui_str': 'Vaseline'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1706094', 'cui_str': 'Dental cement'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0035345', 'cui_str': 'Retired'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",23.0,0.113023,The experimental adhesive showed longer effectiveness than the control and the placebo with a better inhibition capacity for the growth of Candida albicans .,"[{'ForeName': 'Luís', 'Initials': 'L', 'LastName': 'Azevedo', 'Affiliation': 'Department of Conservative Dentistry and Orofacial Prosthodontics, Faculty of Dentistry, Complutense University of Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Correia', 'Affiliation': 'Centre for Interdisciplinary Research in Health, Faculty of Dental Medicine, Universidade Católica Portuguesa, 3504 Viseu, Portugal.'}, {'ForeName': 'Carlos F', 'Initials': 'CF', 'LastName': 'Almeida', 'Affiliation': 'Centre for Interdisciplinary Research in Health, Faculty of Dental Medicine, Universidade Católica Portuguesa, 3504 Viseu, Portugal.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Molinero-Mourelle', 'Affiliation': 'Department of Conservative Dentistry and Orofacial Prosthodontics, Faculty of Dentistry, Complutense University of Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Correia', 'Affiliation': 'Centre for Interdisciplinary Research in Health, Faculty of Dental Medicine, Universidade Católica Portuguesa, 3504 Viseu, Portugal.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Del Río Highsmith', 'Affiliation': 'Department of Conservative Dentistry and Orofacial Prosthodontics, Faculty of Dentistry, Complutense University of Madrid, 28040 Madrid, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph18073398'] 2871,33805948,Heart Rate Variability Monitoring during Interferential Current Application in the Lower Back Area: A Cross-Sectional Study.,"Vasovagal reactions may occur occasionally during electrical stimulation using interferential current (IFC). The purpose of this study was to examine variations in autonomic activity during the application of IFC in asymptomatic participants by analysis of their heart rate variability (HRV). Seventy-three male volunteers were randomly assigned to a placebo group ( n = 36; HRV was documented for 10 min, both at rest and during a placebo intervention) and an intervention group ( n = 37; HRV was documented for 10 min in two conditions labelled as (1) rest and (2) application of IFC technique on the lumbar segment). The diameters of the Poincaré plot (SD1, SD2), stress score (SS), and the ratio between sympathetic and parasympathetic activity (S/PS) were measured. After interventions, differences amongst the placebo group and the IFC group were found in SD2 ( p < 0.001), SS ( p = 0.01) and S/PS ratio ( p = 0.003). The IFC technique was associated with increased parasympathetic modulation, which could induce a vasovagal reaction. Monitorization of adverse reactions should be implemented during the application of IFC technique. HRV indicators might have a part in prevention of vasovagal reactions. Further studies in patients with lumbar pain are needed to explore possible differences in HRV responses due to the presence of chronic pain.",2021,"After interventions, differences amongst the placebo group and the IFC group were found in SD2 ( p < 0.001), SS ( p = 0.01) and S/PS ratio ( p = 0.003).","['asymptomatic participants by analysis of their heart rate variability (HRV', 'Seventy-three male volunteers', 'patients with lumbar pain']","['Interferential Current Application', 'electrical stimulation using interferential current (IFC', 'placebo', 'IFC', 'placebo intervention) and an intervention group ( n = 37; HRV was documented for 10 min in two conditions labelled as (1) rest and (2) application of IFC technique']","['vasovagal reaction', 'diameters of the Poincaré plot (SD1, SD2), stress score (SS), and the ratio between sympathetic and parasympathetic activity (S/PS', 'parasympathetic modulation', 'SS', 'autonomic activity', 'Vasovagal reactions', 'SD2']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0042420', 'cui_str': 'Vasovagal syncope'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C1861380', 'cui_str': 'Syndactyly, Type I'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}]",73.0,0.128851,"After interventions, differences amongst the placebo group and the IFC group were found in SD2 ( p < 0.001), SS ( p = 0.01) and S/PS ratio ( p = 0.003).","[{'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'De-la-Cruz-Torres', 'Affiliation': 'Department of Physiotherapy, University of Seville, Avicena Street, 41009 Seville, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Martínez-Jiménez', 'Affiliation': 'Facultad de Fisioterapia y Enfermería, Departamento de Enfermería, Universidad de Castilla la Mancha, 45071 Toledo, Spain.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Navarro-Flores', 'Affiliation': 'Frailty Research Organized Group (FROG), Department of Nursing, Faculty of Nursing and Podiatry, University of Valencia, 46001 Valencia, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Palomo-López', 'Affiliation': 'University Center of Plasencia, Faculty of Podiatry, Universidad de Extremadura, 10600 Badajoz, Spain.'}, {'ForeName': 'Vanesa', 'Initials': 'V', 'LastName': 'Abuín-Porras', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Villaviciosa de Odón, 28670 Madrid, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Díaz-Meco-Conde', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Villaviciosa de Odón, 28670 Madrid, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'López-López', 'Affiliation': 'Research, Health and Podiatry Group, Department of Health Sciences, Research, Faculty of Nursing and Podiatry, Universidade da Coruña, 15403 Ferrol, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Romero-Morales', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Villaviciosa de Odón, 28670 Madrid, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph18073394'] 2872,33805025,"Koshu GRoup Activity, Active Play and Exercise (GRAPE) Study: A Cluster Randomised Controlled Trial Protocol of a School-Based Intervention among Japanese Children.","School-based programmes need to be effective, easy for all, easy to perform within a short duration, and inexpensive. However, no studies have reported whether voluntarily and very short-time active play programmes contribute to improved health outcomes. This study aims to describe the GRoup activity, Active Play and Exercise (GRAPE) cluster randomised controlled trial that examined whether active play interventions of very short durations contribute to increasing physical activity (PA) and bone mass among school-aged children. The trial was conducted in 2018 from January to June, and the activity comprised ≥2 children jumping together for approximately 10 s per session, at least five times a day (approximately 1 min/day). School clusters, pair-matched as per school size (total number of children) and region, were randomly allocated to either intervention or wait-list control groups. The primary outcomes comprised objectively measured changes in PA levels (moderate-to-vigorous PA) evaluated using wrist-worn activity trackers from baseline to the one-year follow-up (six-month post-intervention follow-up) and changes in bone mass evaluated using calcaneus quantitative ultrasound parameters. This study could describe the problems and challenges in school-based PA intervention studies and present findings that could make a potentially important contribution to health education and PA promotion.",2021,"School-based programmes need to be effective, easy for all, easy to perform within a short duration, and inexpensive.","['2018 from January to June, and the activity comprised ≥2 children jumping together for approximately 10 s per session, at least five times a day (approximately 1 min/day', 'Japanese Children', 'school-aged children', 'School clusters, pair-matched as per school size (total number of children) and region']","['School-Based Intervention', 'Koshu GRoup Activity, Active Play and Exercise', 'intervention or wait-list control groups', 'GRAPE']","['PA levels (moderate-to-vigorous PA) evaluated using wrist-worn activity trackers', 'physical activity (PA) and bone mass']","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0585292', 'cui_str': 'Five times daily'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0557313', 'cui_str': 'Number of pupils in school'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",,0.0279549,"School-based programmes need to be effective, easy for all, easy to perform within a short duration, and inexpensive.","[{'ForeName': 'Mitsuya', 'Initials': 'M', 'LastName': 'Yamakita', 'Affiliation': 'Faculty of Nursing, Yamanashi Prefectural University, Kofu, Yamanashi 400-0062, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Ando', 'Affiliation': 'Division of Human Sciences, Faculty of Education, Graduate School Department of Interdisciplinary Research, University of Yamanashi, Kofu, Yamanashi 400-8510, Japan.'}, {'ForeName': 'Hayato', 'Initials': 'H', 'LastName': 'Sugita', 'Affiliation': 'Division of Human Sciences, Faculty of Education, Graduate School Department of Interdisciplinary Research, University of Yamanashi, Kofu, Yamanashi 400-8510, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Akiyama', 'Affiliation': 'Department of Health Sciences, Basic Science for Clinical Medicine, Division of Medicine, Graduate School Department of Interdisciplinary Research, University of Yamanashi, Chuo, Yamanashi 409-3898, Japan.'}, {'ForeName': 'Miri', 'Initials': 'M', 'LastName': 'Sato', 'Affiliation': 'Department of Health Sciences, Basic Science for Clinical Medicine, Division of Medicine, Graduate School Department of Interdisciplinary Research, University of Yamanashi, Chuo, Yamanashi 409-3898, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yokomichi', 'Affiliation': 'Department of Health Sciences, Basic Science for Clinical Medicine, Division of Medicine, Graduate School Department of Interdisciplinary Research, University of Yamanashi, Chuo, Yamanashi 409-3898, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Yamaguchi', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba, Ibaraki 305-8577, Japan.'}, {'ForeName': 'Zentaro', 'Initials': 'Z', 'LastName': 'Yamagata', 'Affiliation': 'Department of Health Sciences, Basic Science for Clinical Medicine, Division of Medicine, Graduate School Department of Interdisciplinary Research, University of Yamanashi, Chuo, Yamanashi 409-3898, Japan.'}]",International journal of environmental research and public health,['10.3390/ijerph18073351'] 2873,33804999,"The Influence of Probiotic Supplementation on Depressive Symptoms, Inflammation, and Oxidative Stress Parameters and Fecal Microbiota in Patients with Depression Depending on Metabolic Syndrome Comorbidity-PRO-DEMET Randomized Study Protocol.","There is a huge need to search for new treatment options and potential biomarkers of therapeutic response to antidepressant treatment. Depression and metabolic syndrome often coexist, while a pathophysiological overlap, including microbiota changes, may play a role. The paper presents a study protocol that aims to assess the effect of probiotic supplementation on symptoms of depression, anxiety and stress, metabolic parameters, inflammatory and oxidative stress markers, as well as fecal microbiota in adult patients with depressive disorders depending on the co-occurrence of metabolic syndrome. The trial will be a four-arm, parallel-group, prospective, randomized, double-blind, controlled design that will include 200 participants and will last 20 weeks (ClinicalTrials.gov identifier: NCT04756544). The probiotic preparation will contain Lactobacillus helveticus Rosell ® -52, Bifidobacterium longum Rosell ® -175. We will assess the level of depression, anxiety and stress, quality of life, blood pressure, body mass index and waist circumference, white blood cells count, serum levels of C-reactive protein, high-density lipoprotein (HDL) cholesterol, triglycerides, fasting glucose, fecal microbiota composition and the level of some fecal microbiota metabolites, as well as serum inflammatory markers and oxidative stress parameters. The proposed trial may establish a safe and easy-to-use adjunctive treatment option in a subpopulation of depressive patients only partially responsive to pharmacologic therapy.",2021,The proposed trial may establish a safe and easy-to-use adjunctive treatment option in a subpopulation of depressive patients only partially responsive to pharmacologic therapy.,"['Patients with Depression Depending on Metabolic Syndrome Comorbidity-PRO', 'adult patients with depressive disorders depending on the co-occurrence of metabolic syndrome']","['probiotic supplementation', 'Probiotic Supplementation']","['level of depression, anxiety and stress, quality of life, blood pressure, body mass index and waist circumference, white blood cells count, serum levels of C-reactive protein, high-density lipoprotein (HDL) cholesterol, triglycerides, fasting glucose, fecal microbiota composition and the level of some fecal microbiota metabolites, as well as serum inflammatory markers and oxidative stress parameters', 'Depressive Symptoms, Inflammation, and Oxidative Stress Parameters and Fecal Microbiota', 'symptoms of depression, anxiety and stress, metabolic parameters, inflammatory and oxidative stress markers']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",200.0,0.156212,The proposed trial may establish a safe and easy-to-use adjunctive treatment option in a subpopulation of depressive patients only partially responsive to pharmacologic therapy.,"[{'ForeName': 'Oliwia', 'Initials': 'O', 'LastName': 'Gawlik-Kotelnicka', 'Affiliation': 'Department of Affective and Psychotic Disorders, Medical University of Lodz, 92-216 Lodz, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Skowrońska', 'Affiliation': 'Department of Affective and Psychotic Disorders, Medical University of Lodz, 92-216 Lodz, Poland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Margulska', 'Affiliation': 'Admission Department, Central Teaching Hospital of Medical University of Lodz, 92-216 Lodz, Poland.'}, {'ForeName': 'Karolina H', 'Initials': 'KH', 'LastName': 'Czarnecka-Chrebelska', 'Affiliation': 'Department of Biomedicine and Genetics, Medical University of Lodz, 92-213 Lodz, Poland.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Łoniewski', 'Affiliation': 'Department of Biochemical Sciences, Pomeranian Medical University in Szczecin, 71-460 Szczecin, Poland.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Skonieczna-Żydecka', 'Affiliation': 'Department of Biochemical Sciences, Pomeranian Medical University in Szczecin, 71-460 Szczecin, Poland.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Strzelecki', 'Affiliation': 'Department of Affective and Psychotic Disorders, Medical University of Lodz, 92-216 Lodz, Poland.'}]",Journal of clinical medicine,['10.3390/jcm10071342'] 2874,33804409,"Psychological Resilience, Experimentally Manipulated Social Status, and Dietary Intake among Adolescents.","Relative to other racial/ethnic groups in the United States, Hispanic American (HA) youth have higher rates of overweight and obesity. Previous work suggests that low perceived social status (SS) promotes excess caloric intake and, thereby, development of obesity. Psychological resilience may play a role in reducing adverse eating behaviors and risk for obesity. The objective of this study was to investigate whether resilience (as measured by the Connor Davidson Resilience Scale) interacts with experimentally manipulated SS to affect dietary intake among HA adolescents ( n = 132). Using a rigged game of Monopoly (Hasbro, Inc.), participants were randomized to a high or low SS condition. Following the Monopoly game, participants consumed an ad libitum lunch and their dietary intake was assessed. There was a significant interaction between resilience and experimentally manipulated SS for total energy intake ( p = 0.006), percent energy needs consumed ( p = 0.005), and sugar intake ( p = 0.004). For the high SS condition, for each increase in resilience score, total energy intake decreased by 7.165 ± 2.866 kcal ( p = 0.014) and percent energy needs consumed decreased by 0.394 ± 0.153 ( p = 0.011). In the low SS condition, sugar intake increased by 0.621 ± 0.240 g for each increase in resilience score ( p = 0.011). After correction for multiple comparisons, the aforementioned interactions, but not simple slopes, were statistically significant.",2021,"There was a significant interaction between resilience and experimentally manipulated SS for total energy intake ( p = 0.006), percent energy needs consumed ( p = 0.005), and sugar intake ( p = 0.004).","['Adolescents', 'HA adolescents ( n = 132']",[],"['total energy intake', 'resilience score', 'adverse eating behaviors and risk for obesity', 'resilience score, total energy intake', 'sugar intake']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0019576', 'cui_str': 'Spanish Americans'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0556234', 'cui_str': 'Sugar intake'}]",,0.0407266,"There was a significant interaction between resilience and experimentally manipulated SS for total energy intake ( p = 0.006), percent energy needs consumed ( p = 0.005), and sugar intake ( p = 0.004).","[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Guazzelli Williamson', 'Affiliation': 'Department of Psychology, University of Oregon, Eugene, OR 97403, USA.'}, {'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Lee', 'Affiliation': 'Department of Health Outcomes and Biomedical Informatics, University of Florida, Gainesville, FL 32611, USA.'}, {'ForeName': 'Darci', 'Initials': 'D', 'LastName': 'Miller', 'Affiliation': 'Department of Health Outcomes and Biomedical Informatics, University of Florida, Gainesville, FL 32611, USA.'}, {'ForeName': 'Tianyao', 'Initials': 'T', 'LastName': 'Huo', 'Affiliation': 'Department of Health Outcomes and Biomedical Informatics, University of Florida, Gainesville, FL 32611, USA.'}, {'ForeName': 'Jon K', 'Initials': 'JK', 'LastName': 'Maner', 'Affiliation': 'Department of Psychology, Florida State University, Tallahassee, FL 32306, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Cardel', 'Affiliation': 'Department of Health Outcomes and Biomedical Informatics, University of Florida, Gainesville, FL 32611, USA.'}]",Nutrients,['10.3390/nu13030806'] 2875,33804285,Metabolic Profiling Analysis Reveals the Potential Contribution of Barley Sprouts against Oxidative Stress and Related Liver Cell Damage in Habitual Alcohol Drinkers.,"Chronic excessive alcohol consumption is associated with multiple liver defects, such as steatosis and cirrhosis, mainly attributable to excessive reactive oxygen species (ROS) production. Barley sprouts ( Hordeum vulgare L.) contain high levels of polyphenols that may serve as potential antioxidants. This study aimed to investigate whether barley sprouts extract powder (BSE) relieves alcohol-induced oxidative stress and related hepatic damages in habitual alcohol drinkers with fatty liver. In a 12-week randomized controlled trial with two arms (placebo or 480 mg/day BSE; n = 76), we measured clinical markers and metabolites at the baseline and endpoint to understand the complex molecular mechanisms. BSE supplementation reduced the magnitude of ROS generation and lipid peroxidation and improved the glutathione antioxidant system. Subsequent metabolomic analysis identified alterations in glutathione metabolism, amino acid metabolism, and fatty acid synthesis pathways, confirming the role of BSE in glutathione-related lipid metabolism. Finally, the unsupervised machine learning algorithm indicated that subjects with lower glutathione reductase at the baseline were responders for liver fat content, and those with higher fatigue and lipid oxidation were responders for γ-glutamyl transferase. These findings suggest that BSE administration may protect against hepatic injury by reducing oxidative stress and changing the metabolism in habitual alcohol drinkers with fatty liver.",2021,BSE supplementation reduced the magnitude of ROS generation and lipid peroxidation and improved the glutathione antioxidant system.,"['Habitual Alcohol Drinkers', 'habitual alcohol drinkers with fatty liver']","['placebo', 'BSE', 'BSE supplementation', 'barley sprouts extract powder (BSE']","['oxidative stress', 'ROS generation and lipid peroxidation', 'glutathione antioxidant system']","[{'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0085105', 'cui_str': 'Breast self-examination'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0004755', 'cui_str': 'Hordeum'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032861', 'cui_str': 'Powder'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0023775', 'cui_str': 'Lipid peroxidation'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",,0.257964,BSE supplementation reduced the magnitude of ROS generation and lipid peroxidation and improved the glutathione antioxidant system.,"[{'ForeName': 'Hyerin', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Department of Nutritional Science and Food Management, Ewha Womans University, Seoul 03760, Korea.'}, {'ForeName': 'Eunok', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': 'Department of Nutritional Science and Food Management, Graduate Program in System Health Science and Engineering, Ewha Womans University, Seoul 03760, Korea.'}, {'ForeName': 'Yunsoo', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Department of Nutritional Science and Food Management, Ewha Womans University, Seoul 03760, Korea.'}, {'ForeName': 'Hye Yoon', 'Initials': 'HY', 'LastName': 'Jung', 'Affiliation': 'Department of Nutritional Science and Food Management, Ewha Womans University, Seoul 03760, Korea.'}, {'ForeName': 'Kwang-Min', 'Initials': 'KM', 'LastName': 'Kim', 'Affiliation': 'Department of Family Practice and Community Health, Ajou University School of Medicine, Suwon 16449, Korea.'}, {'ForeName': 'Oran', 'Initials': 'O', 'LastName': 'Kwon', 'Affiliation': 'Department of Nutritional Science and Food Management, Ewha Womans University, Seoul 03760, Korea.'}]","Antioxidants (Basel, Switzerland)",['10.3390/antiox10030459'] 2876,33804259,"Strategic Ingestion of High-Protein Dairy Milk during a Resistance Training Program Increases Lean Mass, Strength, and Power in Trained Young Males.","BACKGROUND We evaluated the effects of high-protein dairy milk ingestion on changes in body composition, strength, power, and skeletal muscle regulatory markers following 6 weeks of resistance training in trained young males. METHODS Thirty resistance-trained young males (age: 27 ± 3 years; training experience: 15 ± 2 months) were randomly assigned to one of two groups: high-protein dairy milk (both whey and casein) + resistance training (MR; n = 15) or isoenergetic carbohydrate (maltodextrin 9%) + resistance training (PR; n = 15). Milk and placebo were ingested immediately post-exercise (250 mL; 30 g protein) and 30 min before sleep (250 mL; 30 g protein). Before and after 6 weeks of linear periodized resistance training (4 times/week), body composition (bioelectrical impedance), strength, power, and serum levels of skeletal muscle regulatory markers (insulin-like growth factor 1 (IGF-1), growth hormone, testosterone, cortisol, follistatin, myostatin, and follistatin-myostatin ratio) were assessed. RESULTS The MR group experienced a significantly higher ( p < 0.05) increase in lean mass, strength, and power (upper- and lower-body) than the PR group. Further, IGF-1, growth hormone, testosterone, follistatin, and follistatin-myostatin ratio were significantly increased, while cortisol and myostatin significantly decreased in the MR group than the PR group ( p < 0.05). CONCLUSIONS The strategic ingestion of high-protein dairy milk (post-exercise and pre-sleep) during 6 weeks of resistance training augmented lean mass, strength, power, and altered serum concentrations of skeletal muscle regulatory markers in trained young males compared to placebo.",2021,"The MR group experienced a significantly higher ( p < 0.05) increase in lean mass, strength, and power (upper- and lower-body) than the PR group.","['Trained Young Males', 'Thirty resistance-trained young males (age:\u200927\u2009± 3\u2009years; training experience: 15 ± 2 months', 'trained young males']","['maltodextrin 9%) + resistance training', 'high-protein dairy milk (both whey and casein) + resistance training (MR; n = 15) or isoenergetic carbohydrate ', 'high-protein dairy milk (post-exercise and pre-sleep', 'Milk and placebo', 'placebo', 'resistance training', 'linear periodized resistance training', 'high-protein dairy milk ingestion']","['lean mass, strength, and power (upper- and lower-body', 'body composition (bioelectrical impedance), strength, power, and serum levels of skeletal muscle regulatory markers (insulin-like growth factor 1 (IGF-1), growth hormone, testosterone, cortisol, follistatin, myostatin, and follistatin-myostatin ratio', 'Lean Mass, Strength, and Power', 'body composition, strength, power, and skeletal muscle regulatory markers', 'cortisol and myostatin', 'IGF-1, growth hormone, testosterone, follistatin, and follistatin-myostatin ratio']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0162536', 'cui_str': 'Biolectric Impedance'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0060623', 'cui_str': 'Activin-Binding Protein'}, {'cui': 'C0538238', 'cui_str': 'GDF8 protein, human'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.00630789,"The MR group experienced a significantly higher ( p < 0.05) increase in lean mass, strength, and power (upper- and lower-body) than the PR group.","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Pourabbas', 'Affiliation': 'Department of Exercise Physiology, University of Tehran, Tehran 1961733114, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Department of Exercise Physiology, University of Isfahan, Isfahan 81746-73441, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Hooshmand Moghadam', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad 9177948974, Iran.'}, {'ForeName': 'Darryn S', 'Initials': 'DS', 'LastName': 'Willoughby', 'Affiliation': 'School of Exercise and Sport Science, University of Mary Hardin-Baylor, Belton, TX 76513, USA.'}, {'ForeName': 'Darren G', 'Initials': 'DG', 'LastName': 'Candow', 'Affiliation': 'Faculty of Kinesiology and Health Studies, University of Regina, Regina, SK S4SOA2, Canada.'}, {'ForeName': 'Bradley T', 'Initials': 'BT', 'LastName': 'Elliott', 'Affiliation': 'Translational Physiology Research Group, School of Life Sciences, University of Westminster, London WC2N 5DU, UK.'}, {'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Forbes', 'Affiliation': 'Department of Physical Education, Faculty of Education, Brandon University, Brandon, MB R7A6A9, Canada.'}, {'ForeName': 'Damoon', 'Initials': 'D', 'LastName': 'Ashtary-Larky', 'Affiliation': 'Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz 61357-15794, Iran.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Eskandari', 'Affiliation': 'Department of Exercise Physiology, University of Birjand, Birjand 9717434765, Iran.'}, {'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Health and Human Performance, Marymount University, Arlington, VA 22207, USA.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Dutheil', 'Affiliation': 'Physiological and Psychosocial Stress, CNRS, LaPSCo, Université Clermont Auvergne, F-63000 Clermont-Ferrand, France.'}]",Nutrients,['10.3390/nu13030948'] 2877,33781142,The impact of fluticasone furoate/vilanterol on healthcare resource utilisation in the Salford Lung Study in chronic obstructive pulmonary disease.,"AIM The Salford Lung Study (SLS) in chronic obstructive pulmonary disease (COPD) was a randomised controlled trial evaluating the effectiveness and safety of initiating fluticasone furoate/vilanterol (FF/VI) 100/25 µg versus continuing usual care (UC) in patients with COPD and a history of exacerbations. Here, we investigate the impact of initiating FF/VI on healthcare resource utilisation (HRU) in SLS COPD. METHODS HRU and interventions were determined from patients' electronic health records. Annual rates of on-treatment all-cause and COPD-related secondary care contacts (SCCs) and primary care contacts (PCCs) for FF/VI versus UC were analysed using a general linear model. Costs were derived from national data sources. RESULTS Least-squares (LS) mean annual rates of all-cause (9.81 versus 9.36) and COPD-related (1.57 versus 1.48) SCCs were similar for FF/VI and UC, as were rates of all-cause hospitalisations (0.87 versus 0.82). Mean duration of hospital stay/patient was 4.5 and 4.2 days, respectively. COPD-related SCC mean total cost/patient was £484 FF/VI and £475 UC. LS mean annual rates of all-cause PCCs were significantly higher for FF/VI (21.20 versus 18.88 UC; p  < 0.001). LS mean annual rates of COPD-related PCCs were similar for FF/VI and UC (2.42 versus 2.46). All-cause PCC mean total cost/patient was £900 FF/VI versus £811 UC, but COPD-related PCC costs were similar (£116 versus £114). Direct COPD-related total medical costs/patient were significantly lower for FF/VI (LS geometric mean £806 versus £963 UC; p  < 0.001). DISCUSSION In patients with COPD and exacerbation history, FF/VI may represent a less costly alternative to current therapies.GlaxoSmithKline plc. study HZC115151; ClinicalTrials.gov NCT01551758. The reviews of this paper are available via the supplemental material section.",2021,Direct COPD-related total medical costs/patient were significantly lower for FF/VI (LS geometric mean £806 versus £963 UC; ,"['chronic obstructive pulmonary disease', 'chronic obstructive pulmonary disease (COPD', 'patients with COPD and a history of exacerbations']","['fluticasone furoate/vilanterol (FF/VI', '100/25\u2009µg versus continuing usual care (UC', 'GlaxoSmithKline plc', 'fluticasone furoate/vilanterol', 'Salford Lung Study (SLS']","['SCCs', 'LS mean annual rates of all-cause PCCs', 'healthcare resource utilisation', 'Mean duration of hospital stay/patient', 'LS mean annual rates of COPD-related PCCs', 'Direct COPD-related total medical costs/patient', 'COPD-related PCC costs']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C2935023', 'cui_str': 'vilanterol'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0044609', 'cui_str': '1-piperidinocyclohexanecarbonitrile'}]",,0.438938,Direct COPD-related total medical costs/patient were significantly lower for FF/VI (LS geometric mean £806 versus £963 UC; ,"[{'ForeName': 'Nawar Diar', 'Initials': 'ND', 'LastName': 'Bakerly', 'Affiliation': 'Department of Respiratory Medicine, Salford Royal NHS Foundation Trust, Stott Lane, Salford M6 8HD, UK.'}, {'ForeName': 'Dominy', 'Initials': 'D', 'LastName': 'Browning', 'Affiliation': 'Respiratory Research and Development, GlaxoSmithKline plc., Brentford, Middlesex, UK.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Boucot', 'Affiliation': 'Global Respiratory Therapy Area, GlaxoSmithKline plc., Brentford, Middlesex, UK.'}, {'ForeName': 'Jodie', 'Initials': 'J', 'LastName': 'Crawford', 'Affiliation': 'Clinical Statistics, GlaxoSmithKline plc., Stockley Park West, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'McCorkindale', 'Affiliation': 'NIHR Clinical Research Network Greater Manchester, Citylabs 1.0, Manchester, UK.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Stein', 'Affiliation': 'Manchester Academic Health Sciences Centre, University of Manchester, Citylabs 1.0, Manchester.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'New', 'Affiliation': 'Department of Respiratory Medicine, Salford Royal NHS Foundation Trust, Salford, UK.'}]",Therapeutic advances in respiratory disease,['10.1177/17534666211001013'] 2878,33781141,The value of imaging and clinical outcomes in a phase II clinical trial of a lysophosphatidic acid receptor antagonist in idiopathic pulmonary fibrosis.,"BACKGROUND Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive fibrotic lung disease characterized by worsening dyspnea and lung function and has a median survival of 2-3 years. Forced vital capacity (FVC) is the primary endpoint used most commonly in IPF clinical trials as it is the best surrogate for mortality. This study assessed quantitative scores from high-resolution computed tomography (HRCT) developed by machine learning as a secondary efficacy endpoint in a 26-week phase II study of BMS-986020 - an LPA 1 receptor antagonist - in patients with IPF. METHODS HRCT scans from 96% (137/142) of randomized subjects were utilized. Quantitative lung fibrosis (QLF) scores were calculated from the HRCT images. QLF improvement was defined as ⩾2% reduction in QLF score from baseline to week 26. RESULTS In the placebo arm, 5% of patients demonstrated an improvement in QLF score at week 26 compared with 15% and 27% of patients in the BMS-986020 600 mg once daily (QD) and twice daily (BID) arms, respectively [ versus placebo: p  = 0.08 (600 mg QD); p  = 0.0098 (600 mg BID)]. Significant correlations were found between changes in QLF and changes in percent predicted FVC, diffusing capacity for carbon monoxide (DLCO), and shortness of breath at week 26 ( ρ  = -0.41, ρ  = -0.22, and ρ  = 0.27, respectively; all p  < 0.01). CONCLUSIONS This study demonstrated the utility of quantitative HRCT as an efficacy endpoint for IPF in a double-blind, placebo-controlled clinical trial setting. The reviews of this paper are available via the supplemental material section.",2021,"Significant correlations were found between changes in QLF and changes in percent predicted FVC, diffusing capacity for carbon monoxide (DLCO), and shortness of breath at week 26 ( ρ  = -0.41, ρ  = -0.22, and ρ  = 0.27, respectively; all p  < 0.01). ","['patients with IPF', 'Idiopathic pulmonary fibrosis (IPF', 'idiopathic pulmonary fibrosis', 'HRCT scans from 96% (137/142) of randomized subjects were utilized']","['quantitative HRCT', 'BMS-986020', 'lysophosphatidic acid receptor antagonist', 'high-resolution computed tomography (HRCT', 'placebo']","['Quantitative lung fibrosis (QLF) scores', 'Forced vital capacity (FVC', 'QLF improvement', 'QLF score', 'FVC, diffusing capacity for carbon monoxide (DLCO), and shortness of breath']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0170267', 'cui_str': 'Receptor, Lysophosphatidic Acid'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0034069', 'cui_str': 'Fibrosis of lung'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}]",,0.318855,"Significant correlations were found between changes in QLF and changes in percent predicted FVC, diffusing capacity for carbon monoxide (DLCO), and shortness of breath at week 26 ( ρ  = -0.41, ρ  = -0.22, and ρ  = 0.27, respectively; all p  < 0.01). ","[{'ForeName': 'Grace Hyun J', 'Initials': 'GHJ', 'LastName': 'Kim', 'Affiliation': 'Department of Radiological Sciences, David-Geffen School of Medicine, and Department of Biostatistics, Fielding School of Public Health, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Jonathan G', 'Initials': 'JG', 'LastName': 'Goldin', 'Affiliation': 'Department of Radiological Sciences, David-Geffen School of Medicine, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Hayes', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Oh', 'Affiliation': 'Department of Radiology, National Jewish Health, Denver, CO, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Soule', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Shuyan', 'Initials': 'S', 'LastName': 'Du', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}]",Therapeutic advances in respiratory disease,['10.1177/17534666211004238'] 2879,33781130,Comparison of outcomes of high-flow nasal cannula and noninvasive positive-pressure ventilation in patients with hypoxemia and various APACHE II scores after extubation.,"AIMS The study aimed to compare and analyze the outcomes of high-flow nasal cannula (HFNC) and noninvasive positive-pressure ventilation (NPPV) in the treatment of patients with acute hypoxemic respiratory failure (AHRF) who had extubation after weaning from mechanical ventilation. METHODS A total 120 patients with AHRF were enrolled into this study. These patients underwent tracheal intubation and mechanical ventilation. They were organized into two groups according to the score of Acute Physiologic Assessment and Chronic Health Evaluation II (APACHE II); group A: APACHE II score <12; group B: 12⩽ APACHE II score <24. Group A had 72 patients and patients given HFNC were randomly assigned to subgroup I while patients given NPPV were assigned to subgroup II (36 patients in each subgroup). Group B had 48 patients and patients given HFNC were randomly assigned to subgroup I while patients given NPPV were assigned to subgroup II (24 patients in each subgroup). General information, respiratory parameters, endpoint event, and comorbidities of adverse effect were compared and analyzed between the two subgroups. RESULTS The incidence of abdominal distension was significantly higher in patients treated with NPPV than in those treated with HFNC in group A (19.44% versus 0, p  = 0.005) and group B (25% versus 0, p  = 0.009). There was no significant difference between the HFNC- and NPPV-treated patients in blood pH, oxygenation index, partial pressure of carbon dioxide, respiratory rate, and blood lactic acid concentration in either group ( p  > 0.05). Occurrence rate of re-intubation within 72 h of extubation was slightly, but not significantly, higher in NPPV-treated patients ( p  > 0.05). CONCLUSION There was no significant difference between HFNC and NPPV in preventing respiratory failure in patients with AHRF with an APACHE II score <24 after extubation. However, HFNC was superior to NPPV with less incidence of abdominal distension. The reviews of this paper are available via the supplemental material section.",2021,There was no significant difference between HFNC and NPPV in preventing respiratory failure in patients with AHRF with an APACHE II score <24 after extubation.,"['patients with acute hypoxemic respiratory failure (AHRF) who had extubation after weaning from mechanical ventilation', 'A total 120 patients with AHRF', 'patients with AHRF with an APACHE II score <24 after extubation', '48 patients and patients given HFNC', 'patients with hypoxemia and various APACHE II scores after extubation', '72 patients and patients given HFNC']","['NPPV', 'HFNC and NPPV', 'high-flow nasal cannula (HFNC) and noninvasive positive-pressure ventilation (NPPV', 'HFNC', 'tracheal intubation and mechanical ventilation', 'high-flow nasal cannula and noninvasive positive-pressure ventilation']","['incidence of abdominal distension', 'respiratory failure', 'General information, respiratory parameters, endpoint event, and comorbidities of adverse effect', 'abdominal distension', 'blood pH, oxygenation index, partial pressure of carbon dioxide, respiratory rate, and blood lactic acid concentration', 'Occurrence rate of re-intubation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4039867', 'cui_str': 'Acute hypoxemic respiratory failure'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0489438', 'cui_str': 'APACHE II score'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}]","[{'cui': 'C3164735', 'cui_str': 'Noninvasive positive pressure ventilation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0853363', 'cui_str': 'Blood pH'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0853170', 'cui_str': 'Blood lactic acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]",120.0,0.026663,There was no significant difference between HFNC and NPPV in preventing respiratory failure in patients with AHRF with an APACHE II score <24 after extubation.,"[{'ForeName': 'Xiaoke', 'Initials': 'X', 'LastName': 'Shang', 'Affiliation': 'Department of Internal Medicine, Zhongnan Hospital of Wuhan University, Wuhan University, Wuhan, China.'}, {'ForeName': 'Yanggan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Internal Medicine, Zhongnan Hospital of Wuhan University, Wuhan University, No.169 East Lake Road, Wuchang District, Wuhan, Hubei, 430071, China.'}]",Therapeutic advances in respiratory disease,['10.1177/17534666211004235'] 2880,33780463,Evaluation of the Arabin cervical pessary for prevention of preterm birth in women with a twin pregnancy and short cervix (STOPPIT-2): An open-label randomised trial and updated meta-analysis.,"BACKGROUND Preterm-labour-associated preterm birth is a common cause of perinatal mortality and morbidity in twin pregnancy. We aimed to test the hypothesis that the Arabin pessary would reduce preterm-labour-associated preterm birth by 40% or greater in women with a twin pregnancy and a short cervix. METHODS AND FINDINGS We conducted an open-label randomised controlled trial in 57 hospital antenatal clinics in the UK and Europe. From 1 April 2015 to 14 February 2019, 2,228 women with a twin pregnancy underwent cervical length screening between 18 weeks 0 days and 20 weeks 6 days of gestation. In total, 503 women with cervical length ≤ 35 mm were randomly assigned to pessary in addition to standard care (n = 250, mean age 32.4 years, mean cervical length 29 mm, with pessary inserted in 230 women [92.0%]) or standard care alone (n = 253, mean age 32.7 years, mean cervical length 30 mm). The pessary was inserted before 21 completed weeks of gestation and removed at between 35 and 36 weeks or before birth if earlier. The primary obstetric outcome, spontaneous onset of labour and birth before 34 weeks 0 days of gestation, was present in 46/250 (18.4%) in the pessary group compared to 52/253 (20.6%) following standard care alone (adjusted odds ratio [aOR] 0.87 [95% CI 0.55-1.38], p = 0.54). The primary neonatal outcome-a composite of any of stillbirth, neonatal death, periventricular leukomalacia, early respiratory morbidity, intraventricular haemorrhage, necrotising enterocolitis, or proven sepsis, from birth to 28 days after the expected date of delivery-was present in 67/500 infants (13.4%) in the pessary group compared to 76/506 (15.0%) following standard care alone (aOR 0.86 [95% CI 0.54-1.36], p = 0.50). The positive and negative likelihood ratios of a short cervix (≤35 mm) to predict preterm birth before 34 weeks were 2.14 and 0.83, respectively. A meta-analysis of data from existing publications (4 studies, 313 women) and from STOPPIT-2 indicated that a cervical pessary does not reduce preterm birth before 34 weeks in women with a short cervix (risk ratio 0.74 [95% CI 0.50-1.11], p = 0.15). No women died in either arm of the study; 4.4% of babies in the Arabin pessary group and 5.5% of babies in the standard treatment group died in utero or in the neonatal period (p = 0.53). Study limitations include lack of power to exclude a smaller than 40% reduction in preterm labour associated preterm birth, and to be conclusive about subgroup analyses. CONCLUSIONS These results led us to reject our hypothesis that the Arabin pessary would reduce the risk of the primary outcome by 40%. Smaller treatment effects cannot be ruled out. TRIAL REGISTRATION ISRCTN Registry ISRCTN 02235181. ClinicalTrials.gov NCT02235181.",2021,No women died in either arm of the study; 4.4% of babies in the Arabin pessary group and 5.5% of babies in the standard treatment group died in utero or in the neonatal period (p = 0.53).,"['women with a twin pregnancy and a short cervix', 'From 1 April 2015 to 14 February 2019, 2,228 women with a twin pregnancy underwent cervical length screening between 18 weeks 0 days and 20 weeks 6 days of gestation', 'women with a twin pregnancy and short cervix (STOPPIT-2', '503 women with cervical length ≤ 35 mm were randomly assigned to pessary in addition to standard care (n = 250, mean age 32.4 years, mean cervical length 29 mm, with pessary inserted in 230 women [92.0%]) or', 'n = 253, mean age 32.7 years, mean cervical length 30 mm', '57 hospital antenatal clinics in the UK and Europe']","['Arabin pessary', 'Arabin cervical pessary', 'standard care alone']","['preterm-labour-associated preterm birth', 'positive and negative likelihood ratios of a short cervix', 'preterm labour associated preterm birth', 'preterm birth', 'spontaneous onset of labour and birth before 34 weeks 0 days of gestation', 'primary neonatal outcome-a composite of any of stillbirth, neonatal death, periventricular leukomalacia, early respiratory morbidity, intraventricular haemorrhage, necrotising enterocolitis, or proven sepsis, from birth to 28 days after the expected date of delivery']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0152150', 'cui_str': 'Twin pregnancy'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0007874', 'cui_str': 'Cervix uteri structure'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517709', 'cui_str': '32.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0450396', 'cui_str': '30mm'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0015176', 'cui_str': 'Europe'}]","[{'cui': 'C0031246', 'cui_str': 'Pessary'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0022876', 'cui_str': 'Premature labor'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0007874', 'cui_str': 'Cervix uteri structure'}, {'cui': 'C0474461', 'cui_str': 'Spontaneous onset of labor'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0410916', 'cui_str': 'Newborn death'}, {'cui': 'C0023529', 'cui_str': 'Periventricular leukomalacia'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1301752', 'cui_str': 'Respiratory morbidity'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]",503.0,0.555058,No women died in either arm of the study; 4.4% of babies in the Arabin pessary group and 5.5% of babies in the standard treatment group died in utero or in the neonatal period (p = 0.53).,"[{'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Norman', 'Affiliation': 'Faculty of Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'Centre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cooper', 'Affiliation': 'Centre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Whyte', 'Affiliation': ""Tommy's Centre for Maternal and Fetal Health, MRC Centre for Reproductive Health, University of Edinburgh, Edinburgh, United Kingdom.""}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Chowdhry', 'Affiliation': 'Usher Institute, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Cunningham-Burley', 'Affiliation': 'Usher Institute, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Xue W', 'Initials': 'XW', 'LastName': 'Mei', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Joel B E', 'Initials': 'JBE', 'LastName': 'Smith', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Shennan', 'Affiliation': ""Department of Women's and Children's Health, King's College London, London, United Kingdom.""}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Robson', 'Affiliation': 'Institute of Cellular Medicine, University of Newcastle, Newcastle, United Kingdom.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Thornton', 'Affiliation': 'Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Kilby', 'Affiliation': ""Fetal Medicine Centre, Birmingham Women's and Children's NHS Foundation Trust and College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom.""}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Marlow', 'Affiliation': ""Elizabeth Garrett Anderson Institute for Women's Health, University College London, London, United Kingdom.""}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Stock', 'Affiliation': 'Usher Institute, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Phillip R', 'Initials': 'PR', 'LastName': 'Bennett', 'Affiliation': 'Institute for Reproductive and Developmental Biology, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Denton', 'Affiliation': 'Multiple Births Foundation, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PLoS medicine,['10.1371/journal.pmed.1003506'] 2881,33782383,"A randomised, double-blind, sham-controlled trial of deep brain stimulation of the bed nucleus of the stria terminalis for treatment-resistant obsessive-compulsive disorder.","Deep brain stimulation (DBS) is a promising treatment for severe, treatment-resistant obsessive-compulsive disorder (OCD). Here, nine participants (four females, mean age 47.9 ± 10.7 years) were implanted with DBS electrodes bilaterally in the bed nucleus of the stria terminalis (BNST). Following a one-month postoperative recovery phase, participants entered a three-month randomised, double-blind, sham-controlled phase before a twelve-month period of open-label stimulation incorporating a course of cognitive behavioural therapy (CBT). The primary outcome measure was OCD symptoms as rated with the Yale-Brown Obsessive-Compulsive Scale (YBOCS). In the blinded phase, there was a significant benefit of active stimulation over sham (p = 0.025, mean difference 4.9 points). After the open phase, the mean reduction in YBOCS was 16.6 ± 1.9 points (χ 2 (11) = 39.8, p = 3.8 × 10 -5 ), with seven participants classified as responders. CBT resulted in an additive YBOCS reduction of 4.8 ± 3.9 points (p = 0.011). There were two serious adverse events related to the DBS device, the most severe of which was an infection during the open phase necessitating device explantation. There were no serious psychiatric adverse events related to stimulation. An analysis of the structural connectivity of each participant's individualised stimulation field isolated right-hemispheric fibres associated with YBOCS reduction. These included subcortical tracts incorporating the amygdala, hippocampus and stria terminalis, in addition to cortical regions in the ventrolateral and ventromedial prefrontal cortex, parahippocampal, parietal and extrastriate visual cortex. In conclusion, this study provides further evidence supporting the efficacy and tolerability of DBS in the region of the BNST for individuals with otherwise treatment-refractory OCD and identifies a connectivity fingerprint associated with clinical benefit.",2021,CBT resulted in an additive YBOCS reduction of 4.8 ± 3.9 points (p = 0.011).,"['nine participants (four females, mean age 47.9\u2009±\u200910.7 years', 'treatment-resistant obsessive-compulsive disorder']","['Deep brain stimulation (DBS', 'CBT', 'DBS electrodes', 'open-label stimulation incorporating a course of cognitive behavioural therapy (CBT']","['serious psychiatric adverse events', 'mean reduction in YBOCS', 'OCD symptoms as rated with the Yale-Brown Obsessive-Compulsive Scale (YBOCS', 'efficacy and tolerability of DBS']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191365', 'cui_str': '10.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}]",,0.531668,CBT resulted in an additive YBOCS reduction of 4.8 ± 3.9 points (p = 0.011).,"[{'ForeName': 'Philip E', 'Initials': 'PE', 'LastName': 'Mosley', 'Affiliation': 'Systems Neuroscience Group, QIMR Berghofer Medical Research Institute, Herston, QLD, Australia. philip.mosley@qimrberghofer.edu.au.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Windels', 'Affiliation': 'Queensland Brain Institute, University of Queensland, St Lucia, QLD, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Morris', 'Affiliation': 'Queensland Brain Institute, University of Queensland, St Lucia, QLD, Australia.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Coyne', 'Affiliation': 'Queensland Brain Institute, University of Queensland, St Lucia, QLD, Australia.'}, {'ForeName': 'Rodney', 'Initials': 'R', 'LastName': 'Marsh', 'Affiliation': ""Neurosciences Queensland, St Andrew's War Memorial Hospital, Spring Hill, QLD, Australia.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Giorni', 'Affiliation': 'Queensland Brain Institute, University of Queensland, St Lucia, QLD, Australia.'}, {'ForeName': 'Adith', 'Initials': 'A', 'LastName': 'Mohan', 'Affiliation': 'Centre for Healthy Brain Ageing (CHeBA), School of Psychiatry, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Perminder', 'Initials': 'P', 'LastName': 'Sachdev', 'Affiliation': 'Centre for Healthy Brain Ageing (CHeBA), School of Psychiatry, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': ""O'Leary"", 'Affiliation': 'The OCD Clinic, Bulimba, QLD, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Boschen', 'Affiliation': 'School of Applied Psychology, Griffith University, Gold Coast, QLD, Australia.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Sah', 'Affiliation': 'Queensland Brain Institute, University of Queensland, St Lucia, QLD, Australia.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Silburn', 'Affiliation': ""Neurosciences Queensland, St Andrew's War Memorial Hospital, Spring Hill, QLD, Australia.""}]",Translational psychiatry,['10.1038/s41398-021-01307-9'] 2882,33782245,Improvements in Sleep Correlate with Improvements in Clinical Outcomes among Adolescents Undergoing Intensive Interdisciplinary Pain Treatment.,"OBJECTIVES Intensive interdisciplinary pain treatment (IIPT) programs have been shown to restore function, improve coping, and reduce pain in adolescents with chronic pain. Yet, little is known about patients' sleep during IIPT and whether or not improvements in pain treatment outcomes are associated with changes in sleep pre-to-post IIPT treatment. The objectives of the current study were to describe sleep among adolescents entering IIPT and examine associations between sleep parameters and IIPT treatment effects. METHODS Self-reported sleep measures and clinical outcomes (e.g., functional disability, coping, average pain), were collected from 44 adolescents (mean age=14.57, 68.2% female) at admission and discharge from an inpatient IIPT program. Wrist-worn actigraphy data and sleep diaries from participants' first week and last week in the program were analyzed to characterize sleep parameters. RESULTS Participants self-reported poor sleep/wake patterns, high levels of insomnia symptoms, and sub-clinical problems with daytime sleepiness upon admission into IIPT, although actigraphic indices of sleep from the first week of IIPT admission were only just under clinical guidelines for healthy adolescent sleep. Better self-reported sleep quality assessed via aggregated sleep diaries from the first week was associated with improvement in average pain and disability over the course of the program. Furthermore, improvements in insomnia symptoms and daytime sleepiness throughout the program were positively correlated with concurrent improvements in functional disability and coping. DISCUSSION Taken together, results suggest that sleep may be associated with IIPT treatment effects and pave the way for future research to continue examining these relationships.",2021,Better self-reported sleep quality assessed via aggregated sleep diaries from the first week was associated with improvement in average pain and disability over the course of the program.,"['healthy adolescent sleep', 'adolescents with chronic pain', 'Adolescents Undergoing Intensive Interdisciplinary Pain Treatment', '44 adolescents (mean age=14.57, 68.2% female) at admission and discharge from an inpatient IIPT program']",['Intensive interdisciplinary pain treatment (IIPT) programs'],"['sleep measures and clinical outcomes (e.g., functional disability, coping, average pain', 'insomnia symptoms and daytime sleepiness', 'average pain and disability', 'functional disability and coping', 'Wrist-worn actigraphy data and sleep diaries', 'sleep quality assessed via aggregated sleep diaries']","[{'cui': 'C0686747', 'cui_str': 'Well adolescent'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0332621', 'cui_str': 'Aggregation'}]",44.0,0.0683297,Better self-reported sleep quality assessed via aggregated sleep diaries from the first week was associated with improvement in average pain and disability over the course of the program.,"[{'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Boggero', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center (CCHMC) Department of Oral Health Science, University of Kentucky College of Dentistry Department of Psychology, St. Louis Children's Hospital School of Medicine, Washington University Department of Pediatrics, University of Cincinnati College of Medicine Division of Pulmonary Medicine, CCHMC.""}, {'ForeName': 'Kendra N', 'Initials': 'KN', 'LastName': 'Krietsch', 'Affiliation': ''}, {'ForeName': 'Hannah M', 'Initials': 'HM', 'LastName': 'Pickerill', 'Affiliation': ''}, {'ForeName': 'Kelly C', 'Initials': 'KC', 'LastName': 'Byars', 'Affiliation': ''}, {'ForeName': 'Kendra J', 'Initials': 'KJ', 'LastName': 'Homan', 'Affiliation': ''}, {'ForeName': 'Sara E', 'Initials': 'SE', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'King', 'Affiliation': ''}]",The Clinical journal of pain,['10.1097/AJP.0000000000000936'] 2883,33780735,"Long-term safety, efficacy, and quality of life during adjunctive brivaracetam treatment in patients with uncontrolled epilepsy: An open-label follow-up trial.","OBJECTIVES The primary objective of this long-term follow-up (LTFU) trial was to evaluate the long-term safety and tolerability of brivaracetam (BRV). The secondary objective was to evaluate the maintenance of efficacy of BRV (including quality of life) over time. METHODS This open-label, multicenter, flexible-dose trial (N01379 [NCT01339559]) was conducted in adults (≥16 years) with focal or generalized-onset seizures, who had participated in a placebo (PBO)-controlled trial of adjunctive BRV (N01258: NCT01405508 or N01358: NCT01261325). RESULTS Seven hundred and sixty-six patients received BRV in this LTFU trial (753 had focal seizures and 13 had generalized-onset seizures). Kaplan-Meier-estimated retention was 71.9% at 12 months, and 53.7% at 36 months. Treatment-emergent adverse events (TEAEs) were reported by 643 (83.9%) patients, most commonly headache (104 [13.6%] patients) and dizziness (100 [13.1%] patients). Two hundred and fifty-seven (33.6%) patients had drug-related TEAEs, most commonly somnolence (49 [6.4%] patients) and dizziness (41 [5.4%] patients). Permanent discontinuation of BRV due to TEAEs occurred in 91 (11.9%) patients. Patients with focal seizures had a median percentage reduction in focal seizure frequency of 52.0% and 51.7% were 50% responders (sustained over time); 26.0% were seizurefree for 6 months, and 17.9% were seizurefree for 12 months. 42.4% of patients at 12 months and 46.8% at 24 months had clinically meaningful improvements in Patient Weighted Quality of Life in Epilepsy Questionnaire 31 total score. CONCLUSIONS In this select group of patients who entered the LTFU trial, BRV was generally safe and well tolerated. Results indicate the long-term efficacy of BRV in patients with focal seizures.",2021,"Treatment-emergent adverse events (TEAEs) were reported by 643 (83.9%) patients, most commonly headache (104 [13.6%] patients) and dizziness (100 [13.1%] patients).","['adults (≥16\u202fyears) with focal or generalized-onset seizures, who had participated in a', 'patients with uncontrolled epilepsy', 'patients with focal seizures', 'Two hundred and fifty-seven (33.6', 'Seven hundred and sixty-six patients received BRV in this LTFU trial (753 had focal seizures and 13 had generalized-onset seizures']","['adjunctive brivaracetam treatment', 'brivaracetam (BRV', 'BRV', 'placebo (PBO)-controlled trial of adjunctive BRV']","['Long-term safety, efficacy, and quality of life', 'Patient Weighted Quality of Life in Epilepsy Questionnaire 31 total score', 'Kaplan-Meier-estimated retention', 'focal seizure frequency', 'dizziness', 'efficacy of BRV (including quality of life', 'headache', 'safe and well tolerated']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1720943', 'cui_str': 'Kaplan-Meier Analysis'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018681', 'cui_str': 'Headache'}]",766.0,0.0953179,"Treatment-emergent adverse events (TEAEs) were reported by 643 (83.9%) patients, most commonly headache (104 [13.6%] patients) and dizziness (100 [13.1%] patients).","[{'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Toledo', 'Affiliation': ""Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Brandt', 'Affiliation': 'Bethel Epilepsy Center, Mara Hospital, Bielefeld, Germany. Electronic address: christian.brandt@mara.de.'}, {'ForeName': 'Pier Paolo', 'Initials': 'PP', 'LastName': 'Quarato', 'Affiliation': ""IRCCS Istituto Neurologico, Centro per la Chirurgia dell'Epilessia, Pozzilli, Italy. Electronic address: spleen333@libero.it.""}, {'ForeName': 'Anne-Liv', 'Initials': 'AL', 'LastName': 'Schulz', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany. Electronic address: Anne-Liv.Schulz@ucb.com.'}, {'ForeName': 'Jody M', 'Initials': 'JM', 'LastName': 'Cleveland', 'Affiliation': 'UCB Pharma, Raleigh, NC, USA. Electronic address: Jody.Cleveland@ucb.com.'}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Wagener', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany. Electronic address: Gilbert.Wagener@ucb.com.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Klein', 'Affiliation': 'Mid-Atlantic Epilepsy and Sleep Center, Bethesda, MD, USA. Electronic address: kleinp@epilepsydc.com.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2021.107897'] 2884,33785530,Correction: Impact of oral corticosteroids on respiratory outcomes in acute preschool wheeze: a randomised clinical trial.,,2021,,['acute preschool wheeze'],['oral corticosteroids'],['respiratory outcomes'],"[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}]",,0.325618,,[],Archives of disease in childhood,['10.1136/archdischild-2020-318971corr1'] 2885,33804328,"Efficacy of Arabic Coffee and Black Tea in Reducing Halitosis: A Randomized, Double-Blind, Controlled, Crossover Clinical Trial.","The aim of the study was to objectively evaluate the short-term effect of Arabic coffee and black tea on oral halitosis. This study was a single-center, randomized, double-blind, placebo-controlled, crossover clinical trial on 17 healthy individuals. During the initial visit, pre-treatment breath samples were collected from each subject and analyzed using portable gas chromatography (OralChroma™). Four interventions were evaluated, with Arabic coffee and black tea as the test intervention tools, mouthwash containing a solution (0.05% chlorhexidine, 0.05% cetylpyridinium chloride, and 0.14% zinc lactate (CHX-CPC-Zn)) as a positive control, and drinking water as a negative control. Halitosis was induced by rinsing with 10 mL solution of L-cysteine for 30 s. Twenty minutes later, a breath sample was taken to record the baseline volatile sulfur compounds (VSC) levels (T0). Then, the participants were asked to rinse with 10 mL of a randomly-assigned solution for 30 s. Sixty minutes later, another breath sample was recorded (T1). Finally, after 120 min, the final breath sample was recorded (T2). It was found that rinsing with Arabic coffee decreased the level of H 2 S both in the first hour (T1) and the second hour (T2). The reduction was significantly greater at T1 ( p = 0.017). There was a similar result after the volunteers rinsed with black tea. At T2, Arabic coffee showed a substantially greater reduction in H 2 S ( p < 0.001). On the contrary, using CHX-CPC-Zn showed a significant and continuous decrease in H 2 S values in the breath throughout the experiment ( p < 0.001). Water showed no significant impact on the level of VSC ( p = 0.71). This study demonstrates that black tea and Arabic coffee had inhibitory effects on halitosis that was greater in the first hour and was not sustained over a long period. Additionally, Arabic coffee had a greater inhibitory effect on halitosis than black tea.",2021,"At T2, Arabic coffee showed a substantially greater reduction in H 2 S ( p < 0.001).","['Halitosis', '17 healthy individuals']","['mouthwash containing a solution (0.05% chlorhexidine, 0.05% cetylpyridinium chloride, and 0.14% zinc lactate (CHX-CPC-Zn', 'Arabic coffee and black tea', 'placebo', 'Arabic Coffee and Black Tea']","['final breath sample', 'H 2 S values', 'level of VSC', 'level of H 2 S']","[{'cui': 'C0018520', 'cui_str': 'Breath smells unpleasant'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0007907', 'cui_str': 'Cetylpyridinium chloride'}, {'cui': 'C4517430', 'cui_str': '0.14'}, {'cui': 'C2240534', 'cui_str': 'ZINC LACTATE'}, {'cui': 'C0056911', 'cui_str': ""cytidylyl-(3'-5')-cytidine""}, {'cui': 'C0574175', 'cui_str': 'Arabic language'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0452440', 'cui_str': 'Black tea'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0443769', 'cui_str': 'Volatile agent'}, {'cui': 'C0038776', 'cui_str': 'Sulfur compound'}]",17.0,0.247826,"At T2, Arabic coffee showed a substantially greater reduction in H 2 S ( p < 0.001).","[{'ForeName': 'Hamad', 'Initials': 'H', 'LastName': 'Alzoman', 'Affiliation': 'Department of Periodontics and Community Dentistry, College of Dentistry, King Saud University, Riyadh 11545, Saudi Arabia.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Alzahrani', 'Affiliation': 'Dental Intern, College of Dentistry, King Saud University, Riyadh 11545, Saudi Arabia.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Alwehaiby', 'Affiliation': 'Dental Intern, College of Dentistry, King Saud University, Riyadh 11545, Saudi Arabia.'}, {'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Alanazi', 'Affiliation': 'Dental Intern, College of Dentistry, King Saud University, Riyadh 11545, Saudi Arabia.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'AlSarhan', 'Affiliation': 'Department of Periodontics and Community Dentistry, College of Dentistry, King Saud University, Riyadh 11545, Saudi Arabia.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare9030250'] 2886,33804318,Effects of Individualized Low-Intensity Exercise and Its Duration on Recovery Ability in Adults.,"Exercise is recommended to increase physical health and performance. However, it is unclear how low-intensity exercise (LIE) of different durations may affect or improve recovery ability. This study aimed to investigate how LIE-duration with the same volume affects recovery ability in adults. Twenty healthy male adults participated in this study. Participants were randomly assigned to the 30-min ( n = 10) or the 1-h LIE group ( n = 10). The intervention included sixteen exercise sessions/four weeks with a 30-min LIE group, and eight exercise sessions/four weeks with a 1-h LIE group. Heart rate (HR) corresponding to <2 mmol∙L -1 blood lactate (La - ) was controlled for LIE. Pre- and post-testing was conducted before and after 4-week LIE and tests included jogging/running speed (S), HR, and differences (delta; ∆) in HR and S between pre- and post-testing at 1.5, 2.0, and 4.0 mmol∙L -1 La - . Only the HR at 2.0 mmol∙L -1 La - of the 30-min LIE group was decreased in the post-test compared to the pre-test ( p = 0.043). The jogging/running speed of the 1-h LIE group was improved in the post-test compared to the pre-test ( p < 0.001, p = 0.006, p = 0.002, respectively). ∆HR at 2.0 and ∆S between the 30-min and 1-h LIE group at 1.5, 2.0, and 4.0 mmol∙L -1 La - were significantly different ( p = 0.023, p < 0.001, p = 0.002, and p = 0.019, respectively). Furthermore, moderate to high positive correlations between ∆HR and ∆S of all subjects at 1.5 ( r = 0.77), 2.0 ( r = 0.77), and 4.0 ( r = 0.64) mmol∙L -1 La - were observed. The 1-h LIE group showed improved endurance not only in the low-intensity exercise domain, but also in the beginning of the moderate to high-intensity exercise domain while the 30-min LIE group was not affected by the 4-week LIE intervention. Therefore, LIE (<2.0 mmol∙L -1 ) for at least 1-h, twice a week, for 4 weeks is suggested to improve recovery ability in adults.",2021,"The jogging/running speed of the 1-h LIE group was improved in the post-test compared to the pre-test ( p < 0.001, p =","['Twenty healthy male adults participated in this study', 'Adults', 'adults']",['Individualized Low-Intensity Exercise'],"['Heart rate (HR', '∆HR', 'physical health and performance', 'jogging/running speed', 'jogging/running speed (S), HR, and differences (delta; ∆) in HR and S']","[{'cui': 'C0686751', 'cui_str': 'Well male adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0022400', 'cui_str': 'Jogging'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0439097', 'cui_str': 'Delta'}]",20.0,0.0122324,"The jogging/running speed of the 1-h LIE group was improved in the post-test compared to the pre-test ( p < 0.001, p =","[{'ForeName': 'Doowon', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': 'Graduate School of Sports Medicine, CHA University, Seongnam-si 13503, Gyeonggi-do, Korea.'}, {'ForeName': 'Ju-Yeon', 'Initials': 'JY', 'LastName': 'Son', 'Affiliation': 'Graduate School of Sports Medicine, CHA University, Seongnam-si 13503, Gyeonggi-do, Korea.'}, {'ForeName': 'Hyo-Myeong', 'Initials': 'HM', 'LastName': 'Ju', 'Affiliation': 'Graduate School of Sports Medicine, CHA University, Seongnam-si 13503, Gyeonggi-do, Korea.'}, {'ForeName': 'Ji-Hee', 'Initials': 'JH', 'LastName': 'Won', 'Affiliation': 'Graduate School of Sports Medicine, CHA University, Seongnam-si 13503, Gyeonggi-do, Korea.'}, {'ForeName': 'Seung-Bo', 'Initials': 'SB', 'LastName': 'Park', 'Affiliation': 'Graduate School of Sports Medicine, CHA University, Seongnam-si 13503, Gyeonggi-do, Korea.'}, {'ForeName': 'Woo-Hwi', 'Initials': 'WH', 'LastName': 'Yang', 'Affiliation': 'Graduate School of Sports Medicine, CHA University, Seongnam-si 13503, Gyeonggi-do, Korea.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare9030249'] 2887,33803694,Proposal for a Fitness Program in the School Setting during the COVID 19 Pandemic: Effects of an 8-Week CrossFit Program on Psychophysical Well-Being in Healthy Adolescents.,"BACKGROUND The Italian government promoted social distancing, in which the suspension of any social event, suspension of all activities practiced in gyms, sports centers and their closure was ordered. The social distancing in the school environment and the use of strategies to limit viral infection are not very compatible with group motor activity and team sports. The aim of this study is to verify the effectiveness of a CrossFit program in order to mitigate the deficits in fitness caused by COVID-19 prevention measures and to evaluate the effects on self-efficacy in a group of young adolescents. Methodsː 30 healthy participants were randomly allocated into an intervention group (IG) that performed the 8 weeks CrossFit training program or control group (CG). Physical fitness tests (i.e., Squat, push-up, lunge, and 20 m run) and psychological measures Regulatory Emotional Self-Efficacy scale (RESE) were performed at baseline and after 8 weeks. Resultsː After 8 weeks, the intervention group showed significant improvements for all fitness tests ( p < 0.0001). Additionally, higher scores for the RESE negative and positive ( p < 0.0001) scales were found in the intervention group. No statistical differences were found in the control group except for the push up test. Conclusionsː the 8-week CrossFit intervention program could positively affect the general physical well-being and improve the emotional perceived self-efficacy in healthy adolescents.",2021,"Additionally, higher scores for the RESE negative and positive ( p < 0.0001) scales were found in the intervention group.","['Methodsː 30 healthy participants', 'Healthy Adolescents', 'healthy adolescents', 'young adolescents']","['CrossFit intervention program', 'CrossFit training program or control group (CG', '8-Week CrossFit Program', 'CrossFit program']","['Physical fitness tests (i.e., Squat, push-up, lunge, and 20 m run) and psychological measures Regulatory Emotional Self-Efficacy scale (RESE', 'general physical well-being and improve the emotional perceived self-efficacy', 'self-efficacy']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686747', 'cui_str': 'Well adolescent'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",30.0,0.00489571,"Additionally, higher scores for the RESE negative and positive ( p < 0.0001) scales were found in the intervention group.","[{'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Cataldi', 'Affiliation': 'Department of Basic Medical Sciences, Neuroscience and Sense Organs, School of Medicine, University of Bari ""Aldo Moro"", 70124 Bari, Italy.'}, {'ForeName': 'Vincenzo Cristian', 'Initials': 'VC', 'LastName': 'Francavilla', 'Affiliation': 'School of Engineering, Architecture, and Motor Sciences, Kore University of Enna, 94100 Enna, Italy.'}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'Bonavolontà', 'Affiliation': 'Department of Basic Medical Sciences, Neuroscience and Sense Organs, School of Medicine, University of Bari ""Aldo Moro"", 70124 Bari, Italy.'}, {'ForeName': 'Ornella', 'Initials': 'O', 'LastName': 'De Florio', 'Affiliation': 'Department of Basic Medical Sciences, Neuroscience and Sense Organs, School of Medicine, University of Bari ""Aldo Moro"", 70124 Bari, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Carvutto', 'Affiliation': 'Department of Basic Medical Sciences, Neuroscience and Sense Organs, School of Medicine, University of Bari ""Aldo Moro"", 70124 Bari, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'De Candia', 'Affiliation': 'Department of Basic Medical Sciences, Neuroscience and Sense Organs, School of Medicine, University of Bari ""Aldo Moro"", 70124 Bari, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Latino', 'Affiliation': 'Department of Basic Medical Sciences, Neuroscience and Sense Organs, School of Medicine, University of Bari ""Aldo Moro"", 70124 Bari, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Fischetti', 'Affiliation': 'Department of Basic Medical Sciences, Neuroscience and Sense Organs, School of Medicine, University of Bari ""Aldo Moro"", 70124 Bari, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph18063141'] 2888,33803576,"Fruit and Vegetable Intake Assessed by Repeat 24 h Recalls, but Not by A Dietary Screener, Is Associated with Skin Carotenoid Measurements in Children.","Accurate measurement of fruit and vegetable (FV) intake is important for nutrition surveillance and evaluation of dietary interventions. We compared two tools for reporting FV intake to objective measurement of skin carotenoids among children. FV cups/day was assessed by repeated 24 h dietary recalls (24H FV) and the National Cancer Institute's All-Day Fruit and Vegetable Screener (NCI FV). Skin carotenoids were measured by repeated resonance Raman spectroscopy (RRS) of the palm. FV cups were regressed on RRS scores in unadjusted, field-based, and research-setting models with covariates feasible in each scenario. Data were baseline values from children aged 2-12 years in low-income households enrolled in a healthy eating randomized trial in four U.S. states ( n = 177). Twenty-four-hour FV cups were associated with skin carotenoids in all models ( p < 0.001) but NCI FV cups were not. Predicted RRS scores for discrete 24H FV cups provide a guide to interpretation of RRS in children (2 cups FV intake ~36,000 RRS units), with the research-setting scenario generally providing the narrowest prediction range (+/-1924). When self-reported data are required, 24 h recalls are more accurate than NCI FV screener data; and, when limited time, resources, or literacy must be considered, RRS scores can be quickly obtained and easily interpreted.",2021,Twenty-four-hour FV cups were associated with skin carotenoids in all models ( p < 0.001) but NCI FV cups were not.,"['children', 'children aged 2-12 years in low-income households enrolled in a healthy eating randomized trial in four U.S. states ( n = 177']",['fruit and vegetable (FV) intake'],"['RRS scores', 'skin carotenoids', 'Predicted RRS scores', 'Skin carotenoids', 'Skin Carotenoid Measurements']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0037815', 'cui_str': 'Analysis, Raman Spectrum'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0007271', 'cui_str': 'Carotinoid'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",4.0,0.0517946,Twenty-four-hour FV cups were associated with skin carotenoids in all models ( p < 0.001) but NCI FV cups were not.,"[{'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Seguin-Fowler', 'Affiliation': 'Texas A&M AgriLife Research and the Department of Nutrition, Texas A&M University System, College Station, TX 77843, USA.'}, {'ForeName': 'Karla L', 'Initials': 'KL', 'LastName': 'Hanson', 'Affiliation': 'Master of Public Health Program and the Department of Population Medicine and Diagnostic Sciences, Cornell University, Ithaca, NY 14853, USA.'}, {'ForeName': 'Grace A', 'Initials': 'GA', 'LastName': 'Marshall', 'Affiliation': 'Master of Public Health Program and the Department of Population Medicine and Diagnostic Sciences, Cornell University, Ithaca, NY 14853, USA.'}, {'ForeName': 'Emily H', 'Initials': 'EH', 'LastName': 'Belarmino', 'Affiliation': 'Department of Nutrition and Food Science, University of Vermont, Burlington, VT 05405, USA.'}, {'ForeName': 'Stephanie B', 'Initials': 'SB', 'LastName': 'Jilcott Pitts', 'Affiliation': 'Department of Public Health, East Carolina University, Greenville, NC 27834, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Kolodinsky', 'Affiliation': 'Community Development and Applied Economics Department, University of Vermont, Burlington, VT 05405, USA.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Sitaker', 'Affiliation': 'The Evergreen State College, Olympia, WA 98505, USA.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Ammerman', 'Affiliation': 'Department of Nutrition, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA.'}]",Nutrients,['10.3390/nu13030980'] 2889,33803493,The Effect of Music on aEEG Cyclicity in Preterm Neonates.,"Several methods can be used in the neonatal intensive care unit (NICU) to reduce stress and optimize the quality of life during this period of hospitalization. Among these, music could play an important role. We investigated the effect of different kinds of music therapies on the brain activity of very preterm infants using amplitude-integrated EEG. Sixty-four patients were included and randomly assigned to three different groups: live music group, recorded music group, and control group. In both intervention groups, music was started after the appearance of the first quiet-sleep phase, with a subsequent duration of 20 min. Changes between the first and second quiet-sleep epochs were analyzed using the amplitude-integrated EEG. When looking at single parameters of the amplitude-integrated EEG trace, no differences could be found between the groups when comparing their first and second quiet-sleep phase regarding the parameters of change from baseline, quality of the quiet-sleep epoch, and duration. However, when looking at the total cyclicity score of the second quiet-sleep phase, a difference between both intervention groups and the control group could be found (live music therapy vs. control, p = 0.003; recorded music therapy vs. control, p = 0.006). Improvement within the first and second quiet-sleep epochs were detected in both music groups, but not in the control group. We concluded that our study added evidence of the beneficial effect of music on the amplitude-integrated EEG activity in preterm infants.",2021,"Improvement within the first and second quiet-sleep epochs were detected in both music groups, but not in the control group.","['Sixty-four patients', 'Preterm Neonates', 'preterm infants']","['Music', 'live music group, recorded music group, and control group', 'music therapies']","['brain activity', 'amplitude-integrated EEG activity', 'total cyclicity score']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}]","[{'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031084', 'cui_str': 'Periodicities'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",64.0,0.0142533,"Improvement within the first and second quiet-sleep epochs were detected in both music groups, but not in the control group.","[{'ForeName': 'Vito', 'Initials': 'V', 'LastName': 'Giordano', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care and Neuropediatrics, Comprehensive Center for Pediatrics, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Goeral', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care and Neuropediatrics, Comprehensive Center for Pediatrics, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Schrage-Leitner', 'Affiliation': 'Department of Music Therapy, University of Music and Performing Arts, Seilerstätte 26, 1010 Vienna, Austria.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Berger', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care and Neuropediatrics, Comprehensive Center for Pediatrics, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Olischar', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care and Neuropediatrics, Comprehensive Center for Pediatrics, Medical University of Vienna, 1090 Vienna, Austria.'}]","Children (Basel, Switzerland)",['10.3390/children8030208'] 2890,33803412,"Effect of Prism Adaptation Therapy on the Activities of Daily Living and Awareness for Spatial Neglect: A Secondary Analysis of the Randomized, Controlled Trial.","BACKGROUND Rehabilitation for unilateral spatial neglect (USN) using prism adaptation (PA) is one of the most widely used methods, and the effectiveness of PA is well-evidenced. Although the effect of PA generalized various neglect symptoms, the effectiveness for some aspects of neglect is not fully proven. The Catherine Bergego Scale (CBS) was developed to identify problems with the activities of daily living (ADL) caused by USN. The CBS is composed of 10 observation assessments and a self-assessment questionnaire. To assess the self-awareness of USN, the anosognosia score is calculated as the difference between the observational scores and the self-assessment scores. To investigate how PA affects ADL and self-awareness in subacute USN patients during rehabilitation, we analyzed each item of the CBS and self-awareness from a randomized, controlled trial (RCT) that we previously conducted (Mizuno et al., 2011). METHODS A double-masked randomized, controlled trial was conducted to evaluate the effects of a 2-week PA therapy on USN in 8 hospitals in Japan. We compared each item of the CBS, anosognosia score, and absolute value of the anosognosia score between the prism group and the control group. RESULTS Two of ten items (gaze orientation and exploration of personal belongings) were significantly improved in the prism group compared with those in the control group. The absolute value of the anosognosia score was significantly improved by PA. CONCLUSIONS Improvement of oculomotor exploration by PA may generalize the behavioral level in a daily living environment. This study suggested that PA could accelerate the self-awareness of neglect during subacute rehabilitation.",2021,Two of ten items (gaze orientation and exploration of personal belongings) were significantly improved in the prism group compared with those in the control group.,"['8 hospitals in Japan', 'subacute USN patients during rehabilitation']","['Prism Adaptation Therapy', 'PA therapy', 'PA', 'Rehabilitation for unilateral spatial neglect (USN) using prism adaptation (PA']","['absolute value of the anosognosia score', 'Activities of Daily Living and Awareness for Spatial Neglect', 'CBS, anosognosia score, and absolute value of the anosognosia score', 'Catherine Bergego Scale (CBS']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0234507', 'cui_str': 'Anosognosia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.144221,Two of ten items (gaze orientation and exploration of personal belongings) were significantly improved in the prism group compared with those in the control group.,"[{'ForeName': 'Katsuhiro', 'Initials': 'K', 'LastName': 'Mizuno', 'Affiliation': 'Department of Physical Rehabilitation, National Center Hospital, National Center of Neurology and Psychiatry, 4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8551, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Tsujimoto', 'Affiliation': 'Department of Physical Rehabilitation, National Center Hospital, National Center of Neurology and Psychiatry, 4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8551, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Tsuji', 'Affiliation': 'Department of Rehabilitation Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.'}]",Brain sciences,['10.3390/brainsci11030347'] 2891,33802917,"Effect of a Food for Special Medical Purposes for Muscle Recovery, Consisting of Arginine, Glutamine and Beta-Hydroxy-Beta-Methylbutyrate on Body Composition and Skin Health in Overweight and Obese Class I Sedentary Postmenopausal Women.","The consumption of dietary amino acids has been evaluated for therapeutic and safety intervention in obesity. In particular, three molecules have been shown to be effective: arginine, glutamine and leucine (and its metabolite beta-hydroxy-beta-methylbutyrate, HMB). This randomized, double-blinded pilot study in obese postmenopausal patients aimed to evaluate the efficacy of the administration of a specific food for special medical purposes (FSMP) consisting of arginine, glutamine and HMB on body composition, in particular, visceral adipose tissue (VAT), assessed by dual-energy X-ray absorptiometry (DXA), as the primary endpoint. The secondary endpoint was to evaluate the effects on skin health through a validated self-reported questionnaire. A significant improvement on VAT of Δ = -153.600, p = 0.01 was recorded in the intervention group. Skin health showed a significant improvement in the treatment group for the following: bright Δ = 1.400 (0.758; 2.042), elasticity Δ = 0.900 (0.239; 1.561), wrinkles Δ = 0.800 (0.276; 1.324), and on total score, Δ = 3.000 (1.871; 4.129). In the intervention group, the improvement in VAT was associated with an improvement in the bright score (r = -0.58; p = 0.01). In conclusion, this study demonstrated that the intake for 4-weeks of arginine, glutamine and HMB effects a significant reduction in VAT and improves skin condition, while fat free mass (FFM) is maintained, thus achieving ""high-quality"" weight loss.",2021,"A significant improvement on VAT of Δ = -153.600, p = 0.01 was recorded in the intervention group.","['obese postmenopausal patients', 'Overweight and Obese Class', 'I Sedentary Postmenopausal Women']","['specific food for special medical purposes (FSMP) consisting of arginine, glutamine and HMB']","['bright score', 'improvement in VAT', 'VAT', 'skin health through a validated self-reported questionnaire', 'VAT and improves skin condition, while fat free mass (FFM', 'Skin health']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}]","[{'cui': 'C0423899', 'cui_str': 'Above average intellect'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0037274', 'cui_str': 'Disorder of skin'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0271093', 'cui_str': ""Stargardt's disease""}]",,0.0164288,"A significant improvement on VAT of Δ = -153.600, p = 0.01 was recorded in the intervention group.","[{'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Rondanelli', 'Affiliation': 'IRCCS Mondino Foundation, 27100 Pavia, Italy.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Nichetti', 'Affiliation': 'Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ""Istituto Santa Margherita"", University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Peroni', 'Affiliation': 'Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ""Istituto Santa Margherita"", University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Naso', 'Affiliation': 'Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ""Istituto Santa Margherita"", University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Milena Anna', 'Initials': 'MA', 'LastName': 'Faliva', 'Affiliation': 'Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ""Istituto Santa Margherita"", University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Iannello', 'Affiliation': 'General Management, Azienda di Servizi alla Persona ""Istituto Santa Margherita"", 27100 Pavia, Italy.'}, {'ForeName': 'Enrica', 'Initials': 'E', 'LastName': 'Di Paolo', 'Affiliation': 'General Geriatric Unit, Azienda di Servizi alla Persona ""Istituto Santa Margherita"", 27100 Pavia, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Perna', 'Affiliation': 'Department of Biology, Sakhir Campus, College of Science, University of Bahrain, 32038 Sakhir, Bahrain.'}]",Nutrients,['10.3390/nu13030975'] 2892,33802870,Community Health Workers as a Strategy to Tackle Psychosocial Suffering Due to Physical Distancing: A Randomized Controlled Trial.,"BACKGROUND During the COVID-19 pandemic, many primary care professionals were overburdened and experienced difficulties reaching vulnerable patients and meeting the increased need for psychosocial support. This randomized controlled trial (RCT) tested whether a primary healthcare (PHC) based community health worker (CHW) intervention could tackle psychosocial suffering due to physical distancing measures in patients with limited social networks. METHODS CHWs provided 8 weeks of tailored psychosocial support to the intervention group. Control group patients received 'care as usual'. The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline. Self-rated change in psychosocial health at 8 weeks was determined. RESULTS We failed to find a significant effect of the intervention on the prespecified psychosocial health measures. However, the intervention did lead to significant improvement in self-rated change in psychosocial health. CONCLUSIONS This study confirms partially the existing evidence on the effectiveness of CHW interventions as a strategy to address mental health in PHC in a COVID context. Further research is needed to elaborate the implementation of CHWs in PHC to reach vulnerable populations during and after health crises.",2021,"The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline.","['Tackle Psychosocial Suffering Due to Physical Distancing', 'patients with limited social networks']","['CHW interventions', 'primary healthcare (PHC) based community health worker (CHW) intervention']","['Self-rated change in psychosocial health', 'feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19', 'self-rated change in psychosocial health']","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0814554', 'cui_str': 'Social Participation'}, {'cui': 'C0424139', 'cui_str': 'Anxiety and fear'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]",,0.0740553,"The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline.","[{'ForeName': 'Dorien', 'Initials': 'D', 'LastName': 'Vanden Bossche', 'Affiliation': 'Department of Public Health and Primary Care, Faculty of Medicine and Health Sciences, Ghent University, 9000 Ghent, Belgium.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Lagaert', 'Affiliation': 'Department of Public Health and Primary Care, Faculty of Medicine and Health Sciences, Ghent University, 9000 Ghent, Belgium.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Willems', 'Affiliation': 'Department of Public Health and Primary Care, Faculty of Medicine and Health Sciences, Ghent University, 9000 Ghent, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Decat', 'Affiliation': 'Department of Public Health and Primary Care, Faculty of Medicine and Health Sciences, Ghent University, 9000 Ghent, Belgium.'}]",International journal of environmental research and public health,['10.3390/ijerph18063097'] 2893,33802738,Using a Paleo Ratio to Assess Adherence to Paleolithic Dietary Recommendations in a Randomized Controlled Trial of Individuals with Type 2 Diabetes.,"This study is a secondary analysis of a randomized controlled trial using Paleolithic diet and exercise in individuals with type 2 diabetes. We hypothesized that increased adherence to the Paleolithic diet was associated with greater effects on blood pressure, blood lipids and HbA1c independent of weight loss. Participants were asked to follow a Paleolithic diet for 12 weeks and were randomized to supervised exercise or general exercise recommendations. Four-day food records were analyzed, and food items characterized as ""Paleolithic"" or ""not Paleolithic"". Foods considered Paleolithic were lean meat, poultry, fish, seafood, fruits, nuts, berries, seeds, vegetables, and water to drink; ""not Paleolithic"" were legumes, cereals, sugar, salt, processed foods, and dairy products. A Paleo ratio was calculated by dividing the Paleolithic calorie intake by total calorie intake. A multiple regression model predicted the outcome at 12 weeks using the Paleo ratio, group affiliation, and outcome at baseline as predictors. The Paleo ratio increased from 28% at baseline to 94% after the intervention. A higher Paleo ratio was associated with lower fat mass, BMI, waist circumference, systolic blood pressure, and serum triglycerides at 12 weeks, but not with lower HbA1c levels. The Paleo ratio predicted triglyceride levels independent of weight loss ( p = 0.046). Moreover, an increased monounsaturated/saturated fatty acids ratio and an increased polyunsaturated/saturated fatty acids ratio was associated with lower triglyceride levels independent of weight loss. ( p = 0.017 and p = 0.019 respectively). We conclude that a higher degree of adherence to the Paleolithic diet recommendations improved fat quality and was associated with improved triglyceride levels independent of weight loss among individuals with type 2 diabetes.",2021,"A higher Paleo ratio was associated with lower fat mass, BMI, waist circumference, systolic blood pressure, and serum triglycerides at 12 weeks, but not with lower HbA1c levels.","['Individuals with Type 2 Diabetes', 'individuals with type 2 diabetes']","['supervised exercise or general exercise recommendations', 'Paleolithic diet and exercise']","['triglyceride levels', 'Paleo ratio predicted triglyceride levels independent of weight loss', 'Paleo ratio', 'lower fat mass, BMI, waist circumference, systolic blood pressure, and serum triglycerides', 'monounsaturated/saturated fatty acids ratio and an increased polyunsaturated/saturated fatty acids ratio', 'fat quality', 'blood pressure, blood lipids and HbA1c independent of weight loss']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0452423', 'cui_str': 'Stone age diet'}]","[{'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332291', 'cui_str': 'Independent of'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",,0.145181,"A higher Paleo ratio was associated with lower fat mass, BMI, waist circumference, systolic blood pressure, and serum triglycerides at 12 weeks, but not with lower HbA1c levels.","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Mårtensson', 'Affiliation': 'Department of Public Health and Clinical Medicine, Umeå University, 90187 Umeå, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Stomby', 'Affiliation': 'Department of Public Health and Clinical Medicine, Umeå University, 90187 Umeå, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tellström', 'Affiliation': 'Department of Public Health and Clinical Medicine, Umeå University, 90187 Umeå, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Ryberg', 'Affiliation': 'Department of Public Health and Clinical Medicine, Umeå University, 90187 Umeå, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Waling', 'Affiliation': 'Department of Food, Nutrition and Culinary Science, Umeå University, 90187 Umeå, Sweden.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Otten', 'Affiliation': 'Department of Public Health and Clinical Medicine, Umeå University, 90187 Umeå, Sweden.'}]",Nutrients,['10.3390/nu13030969'] 2894,33802593,Nitrosative Redox Homeostasis and Antioxidant Response Defense in Disused Vastus lateralis Muscle in Long-Term Bedrest (Toulouse Cocktail Study).,"Increased oxidative stress by reactive oxygen species (ROS) and reactive nitrogen species (RNS) is a major determinant of disuse-induced muscle atrophy. Muscle biopsies (thigh vastus lateralis, VL ) obtained from healthy male subjects enrolled in the Toulouse Cocktail bedrest (BR) study were used to assess efficacy of an antioxidant cocktail (polyphenols, omega-3, vitamin E, and selenium) to counteract the increased redox homeostasis and enhance the antioxidant defense response by using label-free LC-MS/MS and NITRO-DIGE (nitrosated proteins), qPCR, and laser confocal microscopy. Label-free LC-MS/MS indicated that treatment prevented the redox homeostasis dysregulation and promoted structural remodeling (TPM3, MYH7, MYBPC, MYH1, MYL1, HRC, and LUM), increment of RyR1, myogenesis (CSRP3), and skeletal muscle development (MUSTN1, LMNA, AHNAK). These changes were absent in the Placebo group. Glycolysis, tricarboxylic acid cycle (TCA), oxidative phosphorylation, fatty acid beta-oxidation, and mitochondrial transmembrane transport were normalized in treated subjects. Proteins involved in protein folding were also normalized, whereas protein entailed in ion homeostasis decreased. NITRO-DIGE analysis showed significant protein nitrosylation changes for CAT, CA3, SDHA, and VDAC2 in Treatment vs. Placebo. Similarly, the nuclear factor erythroid 2-related factor 2 (Nrf-2) antioxidant response element (Nrf-2 ARE) signaling pathway showed an enhanced response in the Treatment group. Increased nitrosative redox homeostasis and decreased antioxidant defense response were found in post-BR control (Placebo, n = 10) vs. the antioxidant cocktail treated group (Treatment, n = 10). Taken together, increased nitrosative redox homeostasis and muscle deterioration during BR-driven physical inactivity were prevented, whereas decreased antioxidant nitrosative stress defense response was attenuated by Treatment suggesting positive effects of the nutritional intervention protocol in bedrest.",2021,"NITRO-DIGE analysis showed significant protein nitrosylation changes for CAT, CA3, SDHA, and VDAC2 in Treatment vs. Placebo.",['healthy male subjects enrolled in the Toulouse Cocktail bedrest (BR) study'],"['Placebo', 'antioxidant cocktail (polyphenols, omega-3, vitamin E, and selenium']","['nitrosative redox homeostasis and muscle deterioration', 'protein nitrosylation changes for CAT, CA3, SDHA, and VDAC2', 'redox homeostasis dysregulation and promoted structural remodeling (TPM3, MYH7, MYBPC, MYH1, MYL1, HRC, and LUM), increment of RyR1, myogenesis (CSRP3), and skeletal muscle development', 'Glycolysis, tricarboxylic acid cycle (TCA), oxidative phosphorylation, fatty acid beta-oxidation, and mitochondrial transmembrane transport', 'antioxidant nitrosative stress defense response', 'redox homeostasis and enhance the antioxidant defense response', 'nitrosative redox homeostasis and decreased antioxidant defense response', 'oxidative stress by reactive oxygen species (ROS) and reactive nitrogen species (RNS']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0678420', 'cui_str': 'Cocktail'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0678420', 'cui_str': 'Cocktail'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}]","[{'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0694600', 'cui_str': 'CA3 Field of Hippocampus'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0017055', 'cui_str': 'gamma-Tropomyosin'}, {'cui': 'C0524965', 'cui_str': 'RyR1'}, {'cui': 'C0596997', 'cui_str': 'Myogenesis'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0017952', 'cui_str': 'Glycolysis'}, {'cui': 'C0008858', 'cui_str': 'Krebs cycle pathway'}, {'cui': 'C0030013', 'cui_str': 'Oxidative phosphorylation'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C4505047', 'cui_str': 'Stress, Nitrosative'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0162772', 'cui_str': 'Oxygen Species, Reactive'}, {'cui': 'C0969698', 'cui_str': 'Nitrogen Species, Reactive'}]",,0.0504683,"NITRO-DIGE analysis showed significant protein nitrosylation changes for CAT, CA3, SDHA, and VDAC2 in Treatment vs. Placebo.","[{'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Blottner', 'Affiliation': 'Institute of Integrative Neuroanatomy, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, 10115 Berlin, Germany.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Capitanio', 'Affiliation': 'Department of Biomedical Sciences for Health, University of Milan, Via Luigi Mangiagalli 31, 20133 Milan, Italy.'}, {'ForeName': 'Gabor', 'Initials': 'G', 'LastName': 'Trautmann', 'Affiliation': 'Institute of Integrative Neuroanatomy, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, 10115 Berlin, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Furlan', 'Affiliation': 'C.N.R. Institute of Neuroscience, 35121 Padova, Italy.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Gambara', 'Affiliation': 'Center of Space Medicine Berlin, 10115 Berlin, Germany.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Moriggi', 'Affiliation': 'Department of Biomedical Sciences for Health, University of Milan, Via Luigi Mangiagalli 31, 20133 Milan, Italy.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Block', 'Affiliation': 'Center of Space Medicine Berlin, 10115 Berlin, Germany.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Barbacini', 'Affiliation': 'Department of Biomedical Sciences for Health, University of Milan, Via Luigi Mangiagalli 31, 20133 Milan, Italy.'}, {'ForeName': 'Enrica', 'Initials': 'E', 'LastName': 'Torretta', 'Affiliation': 'IRCCS Istituto Ortopedico Galeazzi, Via Riccardo Galeazzi 4, 20161 Milan, Italy.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Py', 'Affiliation': 'UFR STAPS, INRAE, Université de Montpellier, UMR 866 Dynamique et Métabolisme, 34060 Montpellier, France.'}, {'ForeName': 'Angèle', 'Initials': 'A', 'LastName': 'Chopard', 'Affiliation': 'UFR STAPS, INRAE, Université de Montpellier, UMR 866 Dynamique et Métabolisme, 34060 Montpellier, France.'}, {'ForeName': 'Imre', 'Initials': 'I', 'LastName': 'Vida', 'Affiliation': 'Institute of Integrative Neuroanatomy, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, 10115 Berlin, Germany.'}, {'ForeName': 'Pompeo', 'Initials': 'P', 'LastName': 'Volpe', 'Affiliation': 'Department of Biomedical Sciences, University of Padova, 35122 Padova, Italy.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Gelfi', 'Affiliation': 'Department of Biomedical Sciences for Health, University of Milan, Via Luigi Mangiagalli 31, 20133 Milan, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Salanova', 'Affiliation': 'Institute of Integrative Neuroanatomy, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, 10115 Berlin, Germany.'}]","Antioxidants (Basel, Switzerland)",['10.3390/antiox10030378'] 2895,33802504,Effects of Different Exercise Conditions on Antioxidant Potential and Mental Assessment.,"Exercise increases oxidative stress, leading the body to strengthen its antioxidant defenses, thus reducing the incidence of major diseases. As these associations are relatively unclear for ordinary levels of exercise for reduced stress, this study evaluated the effects of different exercise conditions on diacron-reactive oxygen metabolites (d-ROMs), biological antioxidant potential (BAP), and subjective mood. Forty-nine students (22.4 ± 2.6 years) were assessed using the Profile of Mood States (POMS) before and after exercising for 60 min. Participants were divided into two groups: Group A engaged in compulsory sports and Group B in freely chosen sports. d-ROMs and BAP were measured, and their modified ratio was calculated as an index of antioxidant potential. Physiological evaluation showed significant improvements in BAP and the BAP/d-ROMs ratio, irrespective of exercise condition ( p < 0.001, p < 0.01). Comparison between the exercise conditions revealed a significant difference in the modified ratio ( p < 0.02). In mood assessment, scores on emotion-related scales without vigor improved significantly under both exercise conditions ( p < 0.001). Mental changes were evident after exercise, and potential antioxidant capacity was higher in freely chosen sports ( p < 0.03). Assessment of antioxidant status before and after exercise may provide an objective index of mental and physical conditioning.",2021,"Mental changes were evident after exercise, and potential antioxidant capacity was higher in freely chosen sports ( p < 0.03).",['Forty-nine students (22.4 ± 2.6 years'],"['compulsory sports and Group B in freely chosen sports', 'Different Exercise Conditions']","['d-ROMs and BAP', 'Mental changes', 'Profile of Mood States (POMS', 'Antioxidant Potential and Mental Assessment', 'potential antioxidant capacity', 'diacron-reactive oxygen metabolites (d-ROMs), biological antioxidant potential (BAP), and subjective mood', 'BAP and the BAP/d-ROMs ratio, irrespective of exercise condition', 'oxidative stress', 'modified ratio']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C4049351', 'cui_str': 'Biological antioxidant potential'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.0306306,"Mental changes were evident after exercise, and potential antioxidant capacity was higher in freely chosen sports ( p < 0.03).","[{'ForeName': 'Kanaka', 'Initials': 'K', 'LastName': 'Yatabe', 'Affiliation': 'Department of Sports Medicine, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki 216-8511, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Muroi', 'Affiliation': 'Department of Sports Medicine, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki 216-8511, Japan.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Kumai', 'Affiliation': 'Department of Orthopaedic Surgery, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki 216-8511, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kotani', 'Affiliation': 'Department of Orthopaedic Surgery, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki 216-8511, Japan.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Somemura', 'Affiliation': 'Department of Orthopaedic Surgery, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki 216-8511, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Yui', 'Affiliation': 'Department of Sports Medicine, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki 216-8511, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Murofushi', 'Affiliation': 'Department of Sports Medicine, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki 216-8511, Japan.'}, {'ForeName': 'Fumiko', 'Initials': 'F', 'LastName': 'Terawaki', 'Affiliation': 'Department of Sports Medicine, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki 216-8511, Japan.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Kobayashi', 'Affiliation': 'Orthopaedic Surgery, Yokohama Sports Medical Center, Nissan Stadium, 3302-5 Kozukue-cho, Kohoku-ku, Yokohama 222-0036, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Yudoh', 'Affiliation': 'Department of Frontier Medicine, Institute of Medical Science, St. Marianna University School of Medicine, Kawasaki 216-8511, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Sakurai', 'Affiliation': 'Faculty of Psychology, Rissho University, 4-2-16 Osaki, Shinagawa-ku, Tokyo 141-8602, Japan.'}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Miyano', 'Affiliation': 'Department of Cognitive and Information Sciences, Faculty of Letters, Chiba University, 1-33 Yayoi-cho, Inage-ku, Chiba 263-8522, Japan.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Fujiya', 'Affiliation': 'Department of Sports Medicine, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki 216-8511, Japan.'}]","Sports (Basel, Switzerland)",['10.3390/sports9030036'] 2896,33813328,"Osimertinib versus osimertinib plus chemotherapy for non-small cell lung cancer with EGFR (T790M)-associated resistance to initial EGFR inhibitor treatment: An open-label, randomised phase 2 clinical trial.","BACKGROUND Osimertinib is now a standard treatment for patients with previously untreated EGFR-mutated advanced non-small cell lung cancer (NSCLC). We here investigated whether the combination of osimertinib with cytotoxic chemotherapy might hold additive efficacy, as well as tolerability. PATIENTS AND METHODS We conducted an open-label randomised phase 2 study to evaluate osimertinib and carboplatin-pemetrexed combination in comparison with osimertinib monotherapy in EGFR mutation-positive NSCLC patients who experienced disease progression associated with the emergence of the T790M resistance mutation of EGFR during first-line EGFR-TKI therapy. The primary endpoint was PFS, with secondary endpoints, including OS, response, and safety. Given that osimertinib was approved as a first-line treatment during the study, patient accrual was discontinued, and a final analysis was performed for the 62 enrolled patients. RESULTS Median PFS was 15.8 months for the osimertinib monotherapy group and 14.6 months for the combination therapy group (hazard ratio of 1.09, with a 95% confidence interval of 0.51-2.32; P = .83). Median OS was not reached in either group. The overall response rate was 71.4% in the osimertinib monotherapy group and 53.6% in the combination group. The frequency or severity of known adverse events in the combination group was comparable to those with carboplatin and pemetrexed previously reported, and novel adverse events were not observed in this study. CONCLUSION This is the first randomised study to investigate the efficacy and safety of the combination of osimertinib and cytotoxic chemotherapy for EGFR-mutated NSCLC. The addition of chemotherapy to osimertinib as a second-line treatment did not prolong survival, while it was found to be generally tolerable. This combination strategy will be further validated in the first-line setting. TRIAL REGISTRATION Japan Registry of Clinical Trials (jRCT) identifier: jRCTs071180062.",2021,The overall response rate was 71.4% in the osimertinib monotherapy group and 53.6% in the combination group.,"['comparison with osimertinib monotherapy in EGFR mutation-positive NSCLC patients who experienced disease progression associated with the emergence of the T790M resistance mutation of EGFR during first-line EGFR-TKI therapy', '62 enrolled patients', 'patients with previously untreated EGFR-mutated advanced non-small cell lung cancer (NSCLC']","['cytotoxic chemotherapy', 'osimertinib and carboplatin-pemetrexed combination', 'Osimertinib versus osimertinib plus chemotherapy', 'osimertinib and cytotoxic chemotherapy']","['Median PFS', 'frequency or severity of known adverse events', 'Median OS', 'efficacy and safety', 'PFS, with secondary endpoints, including OS, response, and safety', 'overall response rate']","[{'cui': 'C4058811', 'cui_str': 'osimertinib'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0304497', 'cui_str': 'Cytotoxic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4058811', 'cui_str': 'osimertinib'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",62.0,0.21275,The overall response rate was 71.4% in the osimertinib monotherapy group and 53.6% in the combination group.,"[{'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Asahina', 'Affiliation': 'Department of Respiratory Medicine, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Kishimoto', 'Affiliation': 'Center for Clinical and Translational Research, Kyushu University Hospital, Fukuoka, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Miyata', 'Affiliation': 'Surgical Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Uchida', 'Affiliation': 'Division of Respiratory Medicine, Saitama Medical University International Medical Center, Hidaka, Japan.'}, {'ForeName': 'Kana', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Department of Respiratory Medicine, Miyagi Cancer Center, Natori, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Hamai', 'Affiliation': 'Department of Respiratory Medicine, Hiroshima Prefectural Hospital, Hiroshima, Japan.'}, {'ForeName': 'Taishi', 'Initials': 'T', 'LastName': 'Harada', 'Affiliation': 'Department of Respiratory Medicine, JCHO Kyushu Hospital, Kita-Kyushu, Japan.'}, {'ForeName': 'Yukari', 'Initials': 'Y', 'LastName': 'Tsubata', 'Affiliation': 'Department of Internal Medicine, Division of Medical Oncology & Respiratory Medicine, Shimane University Faculty of Medicine, Izumo, Japan.'}, {'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Sugawara', 'Affiliation': 'Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan.'}, {'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Division of Respiratory Medicine, Saitama Medical University International Medical Center, Hidaka, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Sugio', 'Affiliation': 'Department of Thoracic and Breast Surgery, Oita University Faculty of Medicine, Oita, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Oizumi', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan.'}, {'ForeName': 'Isamu', 'Initials': 'I', 'LastName': 'Okamoto', 'Affiliation': 'Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. Electronic address: okamotoi@kokyu.med.kyushu-u.ac.jp.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2021.02.019'] 2897,33813267,Potential effectiveness of a surgeon-delivered exercise prescription and an activity tracker on pre-operative exercise adherence and aerobic capacity of lung cancer patients.,"OBJECTIVES Pre-operative exercise may improve functional outcomes for lung cancer patients, but barriers associated with cost, resources, and burden make it challenging to deliver pre-operative exercise programs. The goal of this proof-of-concept study was to determine level of moderate-vigorous physical activity (MVPA) and change in aerobic capacity after participation in a home-based pre-operative exercise intervention. MATERIALS AND METHODS Eighteen patients scheduled for surgery for suspected stage I-III lung cancer received an exercise prescription from their surgeon and wore a commercially-available device that tracked their daily MVPA throughout the pre-operative period. Descriptive statistics were used to calculate adherence to the exercise prescription. A one-sample t-test was used to explore change in aerobic capacity from baseline to the day of surgery. RESULTS Participants exhibited a mean of 20.4 (sd = 46.2) minutes of MVPA per day during the pre-operative period. On average, the sample met the goal of 30 min of MVPA on 16.4% of the days during the pre-operative period. The mean distance achieved at baseline for the 6-min walk test was 456.7 m (sd = 72.9), which increased to 471.1 m (sd = 88.4) on the day of surgery. This equates to a mean improvement of 13.8 m (sd = 37.0), but this difference was not statistically different from zero (p = 0.14). Eight of the 17 participants (47%) demonstrated a clinically significant improvement of 14 m or more. CONCLUSION A surgeon-delivered exercise prescription plus an activity tracker may promote clinically significant improvement in aerobic capacity and MVPA engagement among patients with lung cancer during the pre-operative period, but may need to be augmented with more contact with and support from practitioners over time to maximize benefits. TRIAL REGISTRATION The study protocol was registered with ClinicalTrials.gov prior to initiating participant recruitment (NCT03162718).",2021,"The mean distance achieved at baseline for the 6-min walk test was 456.7 m (sd = 72.9), which increased to 471.1 m (sd = 88.4) on the day of surgery.","['lung cancer patients', 'Eighteen patients scheduled for surgery for suspected stage I-III lung cancer', 'patients with lung cancer']","['MVPA', 'surgeon-delivered exercise prescription and an activity tracker', 'exercise prescription plus an activity tracker', 'exercise prescription from their surgeon and wore a commercially-available device that tracked their daily MVPA']","['aerobic capacity', 'aerobic capacity and MVPA engagement', 'mean distance', 'functional outcomes', 'moderate-vigorous physical activity (MVPA) and change in aerobic capacity']","[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0588464', 'cui_str': 'Exercise on prescription'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",18.0,0.136716,"The mean distance achieved at baseline for the 6-min walk test was 456.7 m (sd = 72.9), which increased to 471.1 m (sd = 88.4) on the day of surgery.","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Finley', 'Affiliation': 'Department of Surgery, Section Thoracic Surgery, Dartmouth-Hitchcock Health, 1 Medical Center Drive, Lebanon, NH, 03756, USA. Electronic address: David.J.Finley@hitchcock.org.'}, {'ForeName': 'Courtney J', 'Initials': 'CJ', 'LastName': 'Stevens', 'Affiliation': 'Department of Psychiatry, Dartmouth-Hitchcock Health, Dartmouth Centers for Health & Aging, 46 Centerra Parkway, Lebanon, NH, 03756, USA. Electronic address: Courtney.j.stevens@dartmouth.edu.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Emond', 'Affiliation': 'Department of Biomedical Data Sciences, Geisel School of Medicine, Dartmouth College, 1 Medical Center Drive, Lebanon, NH, 03756, USA. Electronic address: Jennifer.A.Emond@dartmouth.edu.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Batsis', 'Affiliation': 'Department of Medicine, Dartmouth-Hitchcock Health, The Dartmouth Institute for Health Policy & Clinical Practice, Geisel School of Medicine, 1 Medical Center Drive, Lebanon, NH, 03756, USA. Electronic address: john.batsis@gmail.com.'}, {'ForeName': 'Kayla A', 'Initials': 'KA', 'LastName': 'Fay', 'Affiliation': 'Department of Surgery, Section of Thoracic Surgery, Dartmouth-Hitchcock Health, 1 Medical Center Dr., Lebanon, NH, 03756, USA. Electronic address: Kayla.A.Fay@hitchcock.org.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Darabos', 'Affiliation': 'Information, Technology and Consulting, Dartmouth College, 4 Currier Place, Hanover, NH, 03748, USA; Department of Biomedical Data Sciences, Geisel School of Medicine, Dartmouth College, 1 Medical Center Drive, Lebanon, NH, 03756, USA. Electronic address: Christian.Darabos@dartmouth.edu.'}, {'ForeName': 'Olivia A', 'Initials': 'OA', 'LastName': 'Sacks', 'Affiliation': 'Department of Surgery, Boston Medical Center, 1 Boston Medical Center Place, Boston, MA, 02118, USA. Electronic address: Olivia.Sacks@bmc.org.'}, {'ForeName': 'Summer B', 'Initials': 'SB', 'LastName': 'Cook', 'Affiliation': 'Department of Kinesiology, University of New Hampshire, 124 Main Street, Durham, NH, 03824, USA. Electronic address: summer.cook@unh.edu.'}, {'ForeName': 'Kathleen Doyle', 'Initials': 'KD', 'LastName': 'Lyons', 'Affiliation': 'Department of Psychiatry Research, Dartmouth-Hitchcock Health, 1 Medical Center Dr., Lebanon, NH, 03756, USA. Electronic address: Kathleen.D.Lyons@dartmouth.edu.'}]",Surgical oncology,['10.1016/j.suronc.2021.101525'] 2898,33813246,"A prospective randomized trial comparing computerized columnar insulin dosing chart (the Atlanta protocol) versus the joint British diabetes societies for inpatient care protocol in management of hyperglycemia in patients with acute coronary syndrome admitted to cardiac care unit in Alexandria, Egypt.","BACKGROUND Hyperglycemia in acute coronary syndrome (ACS) is linked to raised morbidity and mortality. Insulin administration using insulin infusion protocols (IIP) is the preferred strategy to control hyperglycemia in critically ill patients. To date, no specific IIP has been identified as the most efficient for achieving glycemic control. AIM to compare glycemic achievements (safety) (primary objective), and coronary and other clinical outcomes (efficacy) (secondary objective) by hyperglycemia management in Cardiac Care Unit (CCU) using computerized Atlanta Protocol (Group (I)) versus paper-based Joint British Diabetes Societies (JBDS) For Inpatient Care Protocol (Group (II)). PATIENTS AND METHODS The study was done on 100 ACS patients admitted to Alexandria Main University hospital CCU with RBG >180 mg/dL. They were randomized into the 2 groups in a 1:1 ratio. CBG was measured hourly for 72 hours and was managed by IV insulin infusion. RESULTS Group (I) showed statistically significant less mean time for target BG achievement (3.52 ± 1.53hours), lower incidence of Level 1 hypoglycemia (2%) than Group (II) (4.76 ± 2.33 hours, 22%, p = 0.013, 0.002 respectively) and statistically significant less mean number of episodes above the glycemic target after its achievement than Group (II) (p < 0.001). Regarding Level 2 hypoglycemia the difference was not significant statistically. CONCLUSION Both protocols successfully maintained target BG level with low incidence of clinically significant hypoglycemia, however, the computerized Atlanta protocol achieved better glycemic outcomes. We recommend the use of the computerized Atlanta protocol in CCU rather than JBDS for Inpatient Care Protocol whenever this is feasible.",2021,"RESULTS Group (I) showed statistically significant less mean time for target BG achievement (3.52 ± 1.53hours), lower incidence of Level 1 hypoglycemia (2%) than Group (II) (4.76 ± 2.33 hours, 22%, p = 0.013, 0.002 respectively) and statistically significant less mean number of episodes above the glycemic target after its achievement than Group (II)","['100 ACS patients admitted to Alexandria Main University hospital CCU with RBG >180\xa0mg/dL', 'critically ill patients', 'acute coronary syndrome (ACS', 'patients with acute coronary syndrome admitted to cardiac care unit in Alexandria, Egypt']","['Insulin administration using insulin infusion protocols (IIP', 'hyperglycemia management in Cardiac Care Unit (CCU) using computerized Atlanta Protocol (Group (I)) versus paper-based Joint British Diabetes Societies (JBDS', 'computerized columnar insulin dosing chart (the Atlanta protocol']","['glycemic outcomes', 'mean time for target BG achievement', 'CBG', 'incidence of Level 1 hypoglycemia']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0150158', 'cui_str': 'Cardiac care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}]","[{'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0240016', 'cui_str': 'Insulin used'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0150252', 'cui_str': 'Hyperglycemia management'}, {'cui': 'C0150158', 'cui_str': 'Cardiac care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0684240', 'cui_str': 'Chart'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C1452313', 'cui_str': 'CBG'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}]",100.0,0.0343488,"RESULTS Group (I) showed statistically significant less mean time for target BG achievement (3.52 ± 1.53hours), lower incidence of Level 1 hypoglycemia (2%) than Group (II) (4.76 ± 2.33 hours, 22%, p = 0.013, 0.002 respectively) and statistically significant less mean number of episodes above the glycemic target after its achievement than Group (II)","[{'ForeName': 'Mohamed H', 'Initials': 'MH', 'LastName': 'Zeitoun', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, University of Alexandria, Egypt.'}, {'ForeName': 'Ali A', 'Initials': 'AA', 'LastName': 'Abdel-Rahim', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, University of Alexandria, Egypt.'}, {'ForeName': 'Mahmoud M', 'Initials': 'MM', 'LastName': 'Hasanin', 'Affiliation': 'Department of Cardiology and Angiology, Faculty of Medicine, University of Alexandria, Egypt.'}, {'ForeName': 'Abeer S', 'Initials': 'AS', 'LastName': 'El Hadidi', 'Affiliation': 'Department of Clinical and Chemical Pathology, Faculty of Medicine, University of Alexandria, Egypt.'}, {'ForeName': 'Wafaa A', 'Initials': 'WA', 'LastName': 'Shahin', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, University of Alexandria, Egypt. Electronic address: W_antar201010@alexmed.edu.eg.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2021.03.024'] 2899,33785672,Ultrasound-guided transversalis fascia plane block versus transmuscular quadratus lumborum block for post-operative analgesia in inguinal hernia repair.,"Background Inguinal hernia repair is one of the most commonly performed surgical procedures. Regional blocks might provide excellent analgesia and reduce complications in the postoperative period. We aimed to compare the postoperative analgesic effect of the ultrasound-guided transversalis fascia (TF) plane block versus the transmuscular quadratus lumborum (QL) block in patients undergoing unilateral inguinal hernia repair. Methods Fifty patients enrolled in this comparative study and were randomly assigned into two equal groups. One group received an ultrasound-guided QL block. In comparison, the other group received an ultrasound-guided TF plane block. The primary outcome was the patient-assessed resting, and movement-induced pain on the numeric pain rating scale (NRS) measured at 30 minutes postoperatively. Secondary outcomes included the percentage of patients receiving rescue analgesia in the first postoperative day, ease of performance of the technique, and incidence of adverse effects. Results There were no statistically significant differences in NRS at rest and with movement between the groups over the first 24 hours postoperatively. The proportion of patients that received postoperative rescue analgesics during the first 30 minutes postoperatively was 4% (n = 1) in the QL group compared to 12% (n = 3) in the TF group. However, the mean performance time of the TF block was shorter than that of the QL block, and the performance of the TF block appeared easier technically. Conclusions The ultrasound-guided TF plane block could be as effective as the QL block in lowering pain scores and decreasing opioid consumption following non-recurrent inguinal herniorrhaphy.",2021,There were no statistically significant differences in NRS at rest and with movement between the groups over the first 24 hours postoperatively.,"['Methods\n\n\nFifty patients enrolled in this comparative study', 'patients undergoing unilateral inguinal hernia repair', 'inguinal hernia repair']","['ultrasound-guided QL block', 'ultrasound-guided transversalis fascia (TF) plane block versus the transmuscular quadratus lumborum (QL) block', 'Ultrasound-guided transversalis fascia plane block versus transmuscular quadratus lumborum block', 'ultrasound-guided TF plane block']","['patient-assessed resting, and movement-induced pain on the numeric pain rating scale (NRS', 'NRS', 'postoperative analgesic effect', 'opioid consumption', 'postoperative rescue analgesics', 'percentage of patients receiving rescue analgesia in the first postoperative day, ease of performance of the technique, and incidence of adverse effects', 'mean performance time of the TF block']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009491', 'cui_str': 'Comparative Studies'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0225232', 'cui_str': 'Transversalis fascia structure'}, {'cui': 'C0444660', 'cui_str': 'Plane'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0225232', 'cui_str': 'Transversalis fascia structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]",50.0,0.162156,There were no statistically significant differences in NRS at rest and with movement between the groups over the first 24 hours postoperatively.,"[{'ForeName': 'Ahmed Zaghloul', 'Initials': 'AZ', 'LastName': 'Fouad', 'Affiliation': 'Department of Anesthesia, Surgical Intensive Care and Pain Management, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Iman Riad M', 'Initials': 'IRM', 'LastName': 'Abdel-Aal', 'Affiliation': 'Department of Anesthesia, Surgical Intensive Care and Pain Management, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed Rabie Mohamed Ali', 'Initials': 'MRMA', 'LastName': 'Gadelrab', 'Affiliation': 'Department of Anesthesia, Agouza Police Hospital, Giza, Egypt.'}, {'ForeName': 'Hany Mohammed El-Hadi Shoukat', 'Initials': 'HMES', 'LastName': 'Mohammed', 'Affiliation': 'Department of Anesthesia, Surgical Intensive Care and Pain Management, Cairo University, Cairo, Egypt.'}]",The Korean journal of pain,['10.3344/kjp.2021.34.2.201'] 2900,33785496,Clinical and cost effectiveness of a corticosteroid injection versus exercise therapy for shoulder pain in general practice: protocol for a randomised controlled trial (SIX Study).,"INTRODUCTION Shoulder pain is common and the prognosis is often unfavourable. Dutch guidelines on the treatment of shoulder pain in primary care recommend a corticosteroid injection or a referral to exercise therapy, if initial pain management fails and pain persists. However, evidence of the effectiveness of a corticosteroid injection compared with exercise therapy, especially in the long term, is limited. This trial will assess the clinical effectiveness and cost effectiveness of a corticosteroid injection compared with physiotherapist-led exercise therapy over 12 months follow-up in patients with shoulder pain in primary care. METHODS AND ANALYSIS The SIX Study is a multicentre, pragmatic randomised clinical trial in primary care. A total of 213 patients with shoulder pain, aged ≥18 years presenting in general practice will be included. Patients will be randomised (1:1) into two groups: a corticosteroid injection or 12 sessions of physiotherapist-led exercise therapy. The effect of the allocated treatment will be assessed through questionnaires at 6 weeks and after 3, 6, 9 and 12 months. The primary outcome is patient's reported shoulder pain-intensity and function, measured with the Shoulder Pain and Disability Index, over 12 months follow-up. Secondary outcomes include cost effectiveness, pain-intensity, function, health-related quality of life, sleep quality, patient's global perceived effect, work absence, healthcare utilisation and adverse events. Between group differences will be evaluated using a repeated measurements analysis with linear effects models. A cost-utility analysis will be performed to assess the cost effectiveness using quality-adjusted life years from a medical and societal perspective. ETHICS AND DISSEMINATION This study was approved by the Medical Ethics Committee of Erasmus MC University Medical Center Rotterdam (MEC 2020-0300). All participants will give written informed consent prior to data collection. The results from this study will be disseminated in international journals and implemented in the primary care guidelines on shoulder pain. TRIAL REGISTRATION NUMBER Dutch Trial Registry (NL8854).",2021,"The primary outcome is patient's reported shoulder pain-intensity and function, measured with the Shoulder Pain and Disability Index, over 12 months follow-up.","['213 patients with shoulder pain, aged ≥18 years presenting in general practice will be included', 'patients with shoulder pain in primary care', 'shoulder pain in general practice']","['corticosteroid injection or a referral to exercise therapy', 'corticosteroid injection versus exercise therapy', 'corticosteroid injection', 'corticosteroid injection or 12 sessions of physiotherapist-led exercise therapy', 'physiotherapist-led exercise therapy']","[""cost effectiveness, pain-intensity, function, health-related quality of life, sleep quality, patient's global perceived effect, work absence, healthcare utilisation and adverse events"", 'shoulder pain-intensity and function, measured with the Shoulder Pain and Disability Index', 'clinical effectiveness and cost effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}]",213.0,0.124431,"The primary outcome is patient's reported shoulder pain-intensity and function, measured with the Shoulder Pain and Disability Index, over 12 months follow-up.","[{'ForeName': 'Pieter F', 'Initials': 'PF', 'LastName': 'van Doorn', 'Affiliation': 'General Practice, Erasmus MC, Rotterdam, The Netherlands p.vandoorn@erasmusmc.nl.'}, {'ForeName': 'Evelien I T', 'Initials': 'EIT', 'LastName': 'de Schepper', 'Affiliation': 'General Practice, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Dieuwke', 'Initials': 'D', 'LastName': 'Schiphof', 'Affiliation': 'General Practice, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Ramon P G', 'Initials': 'RPG', 'LastName': 'Ottenheijm', 'Affiliation': 'Family Medicine, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Marloes', 'Initials': 'M', 'LastName': 'Thoomes-de Graaf', 'Affiliation': 'Fysio-Experts, Hazerswoude Rijndijk, The Netherlands.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Koopmanschap', 'Affiliation': 'Health Economics and HTA, Erasmus University Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'van Ochten', 'Affiliation': 'General Practice, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Danielle A', 'Initials': 'DA', 'LastName': 'van der Windt', 'Affiliation': 'Primary Care Musculoskeletal Research Centre, Keele University, Keele, UK.'}, {'ForeName': 'Patrick J E', 'Initials': 'PJE', 'LastName': 'Bindels', 'Affiliation': 'General Practice, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Bart W', 'Initials': 'BW', 'LastName': 'Koes', 'Affiliation': 'General Practice, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Runhaar', 'Affiliation': 'General Practice, Erasmus MC, Rotterdam, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2021-050101'] 2901,33780888,Dissonance-based eating disorder prevention among Brazilian young women: A randomized efficacy trial of the Body Project.,"A randomized controlled trial was conducted to assess the efficacy of the Body Project eating disorder prevention program in reducing eating disorder risk factors and symptoms in young Brazilian women. A total of 141 female university students aged 18-30 years old were randomly assigned to one of two conditions: assessment-only condition (n = 78) and Body Project condition (n = 63). Participants completed scales assessing body dissatisfaction, sociocultural influence, disordered eating attitudes and behaviors, eating disorders symptoms, body appreciation, depressive mood and negative affect at baseline, posttest, and at 1- and 6-month follow-ups. Body Project participants showed significantly greater reductions in body dissatisfaction, sociocultural influence, disordered eating, eating disorder symptoms, depressive symptoms, and negative affect, and greater increases in body appreciation (d = .35-.48) compared to assessment-only participants. Most of the effects persisted through 6-month follow-up (d = .35-.74). Results provide evidence that the Body Project is an effective intervention to reduce eating disorder risk factors and eating disorder symptoms among Brazilian young women, and that this intervention is naturally culturally adaptive.",2021,"Results provide evidence that the Body Project is an effective intervention to reduce eating disorder risk factors and eating disorder symptoms among Brazilian young women, and that this intervention is naturally culturally adaptive.","['young Brazilian women', '141 female university students aged 18-30 years old', 'Brazilian young women']","['Body Project eating disorder prevention program', 'Dissonance-based eating disorder prevention']","['eating disorder risk factors and eating disorder symptoms', 'scales assessing body dissatisfaction, sociocultural influence, disordered eating attitudes and behaviors, eating disorders symptoms, body appreciation, depressive mood and negative affect', 'body appreciation', 'body dissatisfaction, sociocultural influence, disordered eating, eating disorder symptoms, depressive symptoms', 'eating disorder risk factors and symptoms']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009242', 'cui_str': 'Cognitive Dissonance'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",141.0,0.010489,"Results provide evidence that the Body Project is an effective intervention to reduce eating disorder risk factors and eating disorder symptoms among Brazilian young women, and that this intervention is naturally culturally adaptive.","[{'ForeName': 'Tassiana Aparecida', 'Initials': 'TA', 'LastName': 'Hudson', 'Affiliation': 'Department of Physical Education, Federal University of Juiz de Fora, s/n José Lourenço Kelmer Street, University Campus, Juiz de Fora, 36036-900, Brazil. Electronic address: tassiana.hudson@estudante.ufjf.br.'}, {'ForeName': 'Ana Carolina Soares', 'Initials': 'ACS', 'LastName': 'Amaral', 'Affiliation': 'Federal Institute of Education, Science and Technology of Southeast of Minas Gerais, 204 Monsenhor José Augusto Street, Barbacena, Minas Gerais, 36205-018, Brazil. Electronic address: ana.amaral@ifsudestemg.edu.br.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Stice', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, 401 Quarry Road, Stanford, CA 94305, United States. Electronic address: estice@stanford.edu.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Gau', 'Affiliation': 'Oregon Research Institute, 1776 Millrace Dr, Eugene, OR 97403, United States. Electronic address: jeffg@ori.org.'}, {'ForeName': 'Maria Elisa Caputo', 'Initials': 'MEC', 'LastName': 'Ferreira', 'Affiliation': 'Department of Physical Education, Federal University of Juiz de Fora, s/n José Lourenço Kelmer Street, University Campus, Juiz de Fora, 36036-900, Brazil. Electronic address: maria.elisa@ufjf.edu.br.'}]",Body image,['10.1016/j.bodyim.2021.03.008'] 2902,33792627,Caloric and nutrient restriction to augment chemotherapy efficacy for acute lymphoblastic leukemia: the IDEAL trial.,"Being overweight or obese (OW/OB) during B-cell acute lymphoblastic leukemia (B-ALL) induction is associated with chemoresistance as quantified by minimal residual disease (MRD). We hypothesized that caloric and nutrient restriction from diet/exercise could lessen gains in fat mass (FM) and reduce postinduction MRD. The Improving Diet and Exercise in ALL (IDEAL) trial enrolled patients 10 to 21 years old, newly diagnosed with B-ALL (n = 40), in comparison with a recent historical control (n = 80). Designed to achieve caloric deficits ≥20% during induction, reduce fat intake/glycemic load, and increase activity, IDEAL's end points were FM gain (primary), MRD ≥0.01%, and adherence/feasibility. Integrated biology explored biomarkers of OW/OB physiology. IDEAL intervention did not significantly reduce median FM change from baseline overall (+5.1% [interquartile range [IQR], 15.8] vs +10.7% [IQR, 16.0]; P = .13), but stratified analysis showed benefit in those OW/OB (+1.5% [IQR, 6.6] vs +9.7% [IQR, 11.1]; P = .02). After accounting for prognostic factors, IDEAL intervention significantly reduced MRD risk (odds ratio, 0.30; 95% confidence interval, 0.09-0.92; P = .02). The trial exceeded its adherence (≥75% of overall diet) and feasibility (≥80% completed visits) thresholds. Integrated biology found the IDEAL intervention increased circulating adiponectin and reduced insulin resistance. The IDEAL intervention was feasible, decreased fat gain in those OW/OB, and reduced MRD. This is the first study in any hematologic malignancy to demonstrate potential benefit from caloric restriction via diet/exercise to augment chemotherapy efficacy and improve disease response. A prospective, randomized trial is warranted for validation. These trials were registered at www.clinicaltrials.gov as #NCT02708108 (IDEAL trial) and #NCT01317940 (historical control).",2021,"IDEAL intervention did not significantly reduce median FM change from baseline overall (+5.1% [interquartile range [IQR], 15.8] vs +10.7% [IQR, 16.0];","['acute lymphoblastic leukemia', 'enrolled patients 10 to 21 years old, newly diagnosed with B-ALL (n = 40), in comparison with a recent historical control (n = 80']",['Caloric and nutrient restriction'],"['OW/OB', 'fat gain in those OW/OB, and reduced MRD', ""fat intake/glycemic load, and increase activity, IDEAL's end points were FM gain (primary), MRD ≥0.01%, and adherence/feasibility"", 'circulating adiponectin and reduced insulin resistance', 'median FM change', 'MRD risk', 'fat mass (FM) and reduce postinduction MRD']","[{'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1292769', 'cui_str': 'Precursor B-cell lymphoblastic leukemia'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C4042927', 'cui_str': 'Glycemic Load'}, {'cui': 'C0474395', 'cui_str': 'Behavior showing increased motor activity'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.123893,"IDEAL intervention did not significantly reduce median FM change from baseline overall (+5.1% [interquartile range [IQR], 15.8] vs +10.7% [IQR, 16.0];","[{'ForeName': 'Etan', 'Initials': 'E', 'LastName': 'Orgel', 'Affiliation': 'Cancer and Blood Disease Institute.'}, {'ForeName': 'Celia', 'Initials': 'C', 'LastName': 'Framson', 'Affiliation': 'Department of Clinical Nutrition, and.'}, {'ForeName': 'Rubi', 'Initials': 'R', 'LastName': 'Buxton', 'Affiliation': ""Division of Pediatric Rehabilitation Medicine, Children's Hospital Los Angeles, Los Angeles, CA.""}, {'ForeName': 'Jiyoon', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Biostatistics and Computational Medicine, Jonathan and Karin Fielding School of Public Health, and.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics and Computational Medicine, Jonathan and Karin Fielding School of Public Health, and.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Tucci', 'Affiliation': ""Division of Pediatric Endocrinology, UCLA Children's Discovery and Innovation Institute, David Geffen School of Medicine, University of California Los Angeles (UCLA), Los Angeles, CA.""}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Freyer', 'Affiliation': 'Cancer and Blood Disease Institute.'}, {'ForeName': 'Weili', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Pediatric Hematology Oncology, Department of Pediatrics, City of Hope National Medical Center, Duarte, CA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Oberley', 'Affiliation': ""Department of Pathology and Laboratory Medicine, Children's Hospital Los Angeles, Los Angeles, CA; and.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Dieli-Conwright', 'Affiliation': 'Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Mittelman', 'Affiliation': ""Division of Pediatric Endocrinology, UCLA Children's Discovery and Innovation Institute, David Geffen School of Medicine, University of California Los Angeles (UCLA), Los Angeles, CA.""}]",Blood advances,['10.1182/bloodadvances.2020004018'] 2903,33792355,A Comparison of Two Diabetes Self-Management Education Programs for the Reduction of Participant A1c Levels.,"PURPOSE Compare the effectiveness of two educational teaching methods for diabetic patients. DESIGN Quasi-experimental study comparing two interventions using a pretest/post-test design. SETTING Three clinics within a western U.S. regional health system. SUBJECTS 818 adult diabetic participants (60.5 mean age, 52% female) attended one to four sessions between 2013-2017, and had A1c tests within 180 days of first attended session and 30 to 365 days after last attended session. INTERVENTION A group-based, highly interactive learning experience (n = 561) and a traditional, lecture-style class (n = 257). MEASURES Pre and post measures of A1c. ANALYSIS Paired t-tests measured change within each group pre-post intervention. Two-sample t-tests measured mean change pre-post intervention between the two groups. Multivariable linear regression measured mean change in A1c between groups, adjusted for pre-test scores and controlling for demographic variables. RESULTS Both interactive and traditional teaching interventions were effective at significantly reducing patient A1c levels by 1.3 ( p < 0.001) and 1.0 ( p < 0.001) points respectively. The between groups difference in A1c was not significant, t(512) = 1.66, p = 0.0985, but when controlling for age, pre-A1c and days post-A1c, the interactive intervention was significantly ( p < 0.05) more effective reducing patient A1c levels by 0.19 points than the traditional intervention. CONCLUSION Group-based, interactive diabetes self-management education programs may be an effective model for reducing patient A1c levels.",2021,Both interactive and traditional teaching interventions were effective at significantly reducing patient A1c levels by 1.3 ( p < 0.001) and 1.0 ( p < 0.001) points respectively.,"['diabetic patients', '818 adult diabetic participants (60.5 mean age, 52% female) attended one to four sessions between 2013-2017, and had A1c tests within 180 days of first attended session and 30 to 365 days after last attended session', 'Three clinics within a western U.S. regional health system']","['highly interactive learning experience', 'educational teaching methods']","['patient A1c levels', 'effective reducing patient A1c levels']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0815244', 'cui_str': 'Interactive Learning'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0039403', 'cui_str': 'Teaching Methods'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",818.0,0.0110862,Both interactive and traditional teaching interventions were effective at significantly reducing patient A1c levels by 1.3 ( p < 0.001) and 1.0 ( p < 0.001) points respectively.,"[{'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Sharpless', 'Affiliation': 'Department of Health Services Administration, 48654School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Borkowski', 'Affiliation': 'Department of Health Services Administration, 48654School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Health Services Administration, 48654School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Hearld', 'Affiliation': 'Department of Health Services Administration, 48654School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Szychowski', 'Affiliation': 'Department of Biostatics, 48653School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA.'}]",American journal of health promotion : AJHP,['10.1177/08901171211003829'] 2904,33803814,Effects of Vitamin and Amino Acid-Enriched Hyaluronic Acid Gel on the Healing of Oral Mucosa: In Vivo and In Vitro Study.,"Background and Objectives : Wound healing is a dynamic process that can be compromised in patients with chronic and metabolic conditions or unhealthy lifestyles. Numerous medical substances designed for topical use, charged with compounds that promote the healing process, have been developed to improve wound healing, especially in compromised subjects. The present study aimed to extend our understanding of the in vivo effects of a hyaluronic acid gel charged with amino acids (HAplus gel, Aminogam gel ® Errekappa Euroterapici spa, Milan, Italy) and study the in vitro effects of the same gel charged with additional substances in an attempt to optimize its formulation. Materials and Methods: In a randomized controlled split-mouth clinical and histological trial, HAplus gel was tested on the gingival tissue of the lower third molar post-extraction socket. The gingiva was collected at the time of extraction (T0) and ten days after the extraction (T1) to be histologically analyzed. During the second stage of the study, culture media with HAplus gel and vitamin C and E at different concentrations (TEST) were tested on human gingival fibroblasts and compared to the HAplus-enriched medium (HA-Control). Results: Histological and immunohistochemical analysis of collected gingiva showed higher microvascular density and collagen fibers organized in closely packed and well-oriented bundles in sites treated with HAplus gel. In the in vitro study, all TEST groups showed an increased viability from 24 h to 48 h. After 24 h, the viability percentage in all experimental groups was below 100% of the HA-Control, demonstrating a mild toxicity. After 48 h from seeding, the TEST groups' viability grew significantly compared to HA-Control. Conclusions: These encouraging preliminary results suggest that the use of HAplus gel enriched with vitamins C and E may be beneficial in patients with conditions that impair soft tissue healing.",2021,"After 24 h, the viability percentage in all experimental groups was below 100% of the HA-Control, demonstrating a mild toxicity.",['patients with chronic and metabolic conditions or unhealthy lifestyles'],"['Vitamin and Amino Acid-Enriched Hyaluronic Acid Gel', 'hyaluronic acid gel charged with amino acids (HAplus gel, Aminogam gel ®', 'culture media with HAplus gel and vitamin C and E at different concentrations (TEST']","['viability', 'viability percentage', 'Healing of Oral Mucosa', 'mild toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]","[{'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C0010454', 'cui_str': 'Culture medium'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0026639', 'cui_str': 'Oral mucous membrane structure'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",,0.0265326,"After 24 h, the viability percentage in all experimental groups was below 100% of the HA-Control, demonstrating a mild toxicity.","[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Canciani', 'Affiliation': 'Department of Biomedical, Surgical and Dental Sciences, University of Milan, Via Mangiagalli 31, 20133 Milan, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Sirello', 'Affiliation': 'Department of Biomedical, Surgical and Dental Sciences, University of Milan, Via Mangiagalli 31, 20133 Milan, Italy.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Pellegrini', 'Affiliation': 'Department of Biomedical, Surgical and Dental Sciences, University of Milan, Via Mangiagalli 31, 20133 Milan, Italy.'}, {'ForeName': 'Dolaji', 'Initials': 'D', 'LastName': 'Henin', 'Affiliation': 'Department of Biomedical, Surgical and Dental Sciences, University of Milan, Via Mangiagalli 31, 20133 Milan, Italy.'}, {'ForeName': 'Mariachiara', 'Initials': 'M', 'LastName': 'Perrotta', 'Affiliation': 'Department of Biomedical, Surgical and Dental Sciences, University of Milan, Via Mangiagalli 31, 20133 Milan, Italy.'}, {'ForeName': 'Marilisa', 'Initials': 'M', 'LastName': 'Toma', 'Affiliation': 'Department of Biomedical, Surgical and Dental Sciences, University of Milan, Via Mangiagalli 31, 20133 Milan, Italy.'}, {'ForeName': 'Nataliya', 'Initials': 'N', 'LastName': 'Khomchyna', 'Affiliation': 'Department of Biomedical, Surgical and Dental Sciences, University of Milan, Via Mangiagalli 31, 20133 Milan, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Dellavia', 'Affiliation': 'Department of Biomedical, Surgical and Dental Sciences, University of Milan, Via Mangiagalli 31, 20133 Milan, Italy.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina57030285'] 2905,33803802,Oat Polar Lipids Improve Cardiometabolic-Related Markers after Breakfast and a Subsequent Standardized Lunch: A Randomized Crossover Study in Healthy Young Adults.,"It has been suggested that intake of polar lipids may beneficially modulate various metabolic variables. The purpose of this study was to evaluate the effect of oat polar lipids on postprandial and second meal glycemic regulation, blood lipids, gastrointestinal hormones, and subjective appetite-related variables in healthy humans. In a randomized design, twenty healthy subjects ingested four liquid cereal-based test beverages (42 g of available carbohydrates) containing: i. 30 g of oat oil with a low concentration (4%) of polar lipids (PLL), ii. 30 g of oat oil containing a high concentration (40%) of polar lipids (PLH), iii. 30 g of rapeseed oil (RSO), and iv. no added lipids (NL). The products were served as breakfast meals followed by a standardized lunch. Test variables were measured at fasting and during 3 h after breakfast and two additional hours following a standardized lunch. PLH reduced glucose and insulin responses after breakfast (0-120 min) compared to RSO, and after lunch (210-330 min) compared to RSO and PLL ( p < 0.05). Compared to RSO, PLH resulted in increased concentrations of the gut hormones GLP-1 and PYY after the standardized lunch ( p < 0.05). The results suggest that oat polar lipids have potential nutraceutical properties by modulating acute and second meal postprandial metabolic responses.",2021,"Compared to RSO, PLH resulted in increased concentrations of the gut hormones GLP-1 and PYY after the standardized lunch ( p < 0.05).","['Healthy Young Adults', 'twenty healthy subjects ingested four', 'healthy humans']","['Standardized Lunch', 'liquid cereal-based test beverages (42 g of available carbohydrates) containing: i. 30 g of oat oil with a low concentration (4%) of polar lipids (PLL', 'Oat Polar Lipids', 'RSO, PLH', 'oat polar lipids', 'rapeseed oil (RSO', 'oat oil containing a high concentration (40%) of polar lipids (PLH']","['no added lipids (NL', 'PLH reduced glucose and insulin responses', 'concentrations of the gut hormones GLP-1', 'postprandial and second meal glycemic regulation, blood lipids, gastrointestinal hormones, and subjective appetite-related variables']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0028753', 'cui_str': 'Oats'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0072982', 'cui_str': 'Brassica Napus Oil'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0017182', 'cui_str': 'Gastrointestinal hormone'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",20.0,0.0315294,"Compared to RSO, PLH resulted in increased concentrations of the gut hormones GLP-1 and PYY after the standardized lunch ( p < 0.05).","[{'ForeName': 'Mohammad Mukul', 'Initials': 'MM', 'LastName': 'Hossain', 'Affiliation': 'Department of Food Technology, Engineering and Nutrition, Lund University, P.O. Box 124, 221 00 Lund, Sweden.'}, {'ForeName': 'Juscelino', 'Initials': 'J', 'LastName': 'Tovar', 'Affiliation': 'Department of Food Technology, Engineering and Nutrition, Lund University, P.O. Box 124, 221 00 Lund, Sweden.'}, {'ForeName': 'Lieselotte', 'Initials': 'L', 'LastName': 'Cloetens', 'Affiliation': 'Division of Pure and Applied Biochemistry, Lund University, P.O. Box 124, 221 00 Lund, Sweden.'}, {'ForeName': 'Maria T Soria', 'Initials': 'MTS', 'LastName': 'Florido', 'Affiliation': 'Division of Pure and Applied Biochemistry, Lund University, P.O. Box 124, 221 00 Lund, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Petersson', 'Affiliation': 'Oatly AB, 261 51 Landskrona, Sweden.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Prothon', 'Affiliation': 'Oatly AB, 261 51 Landskrona, Sweden.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Nilsson', 'Affiliation': 'Department of Food Technology, Engineering and Nutrition, Lund University, P.O. Box 124, 221 00 Lund, Sweden.'}]",Nutrients,['10.3390/nu13030988'] 2906,33803200,"The Effects of Dietary Supplementation of Lactococcus lactis Strain Plasma on Skin Microbiome and Skin Conditions in Healthy Subjects-A Randomized, Double-Blind, Placebo-Controlled Trial.","(1) Background: Lactococcus lactis strain Plasma (LC-Plasma) is a unique strain which directly activates plasmacytoid dendritic cells, resulting in the prevention against broad spectrum of viral infection. Additionally, we found that LC-Plasma intake stimulated skin immunity and prevents Staphylococcus aureus epicutaneous infection. The aim of this study was to investigate the effect of LC-Plasma dietary supplementation on skin microbiome, gene expression in the skin, and skin conditions in healthy subjects. (2) Method: A randomized, double-blind, placebo-controlled, parallel-group trial was conducted. Seventy healthy volunteers were enrolled and assigned into two groups receiving either placebo or LC-Plasma capsules (approximately 1 × 10 11 cells/day) for 8 weeks. The skin microbiome was analyzed by NGS and qPCR. Gene expression was analyzed by qPCR and skin conditions were diagnosed by dermatologists before and after intervention. (3) Result: LC-Plasma supplementation prevented the decrease of Staphylococcus epidermidis and Staphylococcus pasteuri and overgrowth of Propionibacterium acnes . In addition, LC-Plasma supplementation suggested to increase the expression of antimicrobial peptide genes but not tight junction genes. Furthermore, the clinical scores of skin conditions were ameliorated by LC-Plasma supplementation. (4) Conclusions: Our findings provided the insights that the dietary supplementation of LC-Plasma might have stabilizing effects on seasonal change of skin microbiome and skin conditions in healthy subjects.",2021,LC-Plasma supplementation prevented the decrease of Staphylococcus epidermidis and Staphylococcus pasteuri and overgrowth of Propionibacterium acnes .,"['Seventy healthy volunteers', 'healthy subjects', 'Healthy Subjects']","['LC-Plasma dietary supplementation', 'placebo', 'Dietary Supplementation of Lactococcus lactis Strain Plasma', 'placebo or LC-Plasma capsules', 'Placebo', 'LC-Plasma supplementation']","['Gene expression', 'Skin Microbiome and Skin Conditions', 'expression of antimicrobial peptide genes', 'skin microbiome, gene expression in the skin, and skin conditions', 'clinical scores of skin conditions', 'Staphylococcus epidermidis and Staphylococcus pasteuri and overgrowth of Propionibacterium acnes ', 'skin microbiome']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038408', 'cui_str': 'Lactococcus lactis'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0037274', 'cui_str': 'Disorder of skin'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038170', 'cui_str': 'Staphylococcus'}, {'cui': 'C0686815', 'cui_str': 'Staphylococcus pasteuri'}, {'cui': 'C0033477', 'cui_str': 'Propionibacterium acnes'}]",70.0,0.317952,LC-Plasma supplementation prevented the decrease of Staphylococcus epidermidis and Staphylococcus pasteuri and overgrowth of Propionibacterium acnes .,"[{'ForeName': 'Ryohei', 'Initials': 'R', 'LastName': 'Tsuji', 'Affiliation': 'Kirin Central Research Institute, Kirin Holdings Company, Ltd., Kanagawa 236-0004, Japan.'}, {'ForeName': 'Kamiyu', 'Initials': 'K', 'LastName': 'Yazawa', 'Affiliation': 'Kirin Central Research Institute, Kirin Holdings Company, Ltd., Kanagawa 236-0004, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kokubo', 'Affiliation': 'Kirin Central Research Institute, Kirin Holdings Company, Ltd., Kanagawa 236-0004, Japan.'}, {'ForeName': 'Yuumi', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': 'Department of Dermatology, Chiba University Graduate School of Medicine, Chiba 260-8670, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Kanauchi', 'Affiliation': 'Research and Development Strategy Department, Kirin Holdings Company, Ltd., Tokyo 164-0001, Japan.'}]",Microorganisms,['10.3390/microorganisms9030563'] 2907,33803076,"Effects of Cardiovascular, Resistance and Combined Exercise Training on Cardiovascular, Performance and Blood Redox Parameters in Coronary Artery Disease Patients: An 8-Month Training-Detraining Randomized Intervention.","It is well-documented that chronic/regular exercise improves the cardiovascular function, decreases oxidative stress and enhances the antioxidant capacity in coronary artery disease (CAD) patients. However, there is insufficient evidence regarding the chronic effects of different types of training and detraining on cardiovascular function and the levels of oxidative stress and antioxidant status in these patients. Therefore, the present study aimed at investigating the effects of cardiovascular, resistance and combined exercise training followed by a three-month detraining period, on cardiovascular function, physical performance and blood redox status parameters in CAD patients. Sixty coronary artery disease patients were randomly assigned to either a cardiovascular training (CVT, N = 15), resistance training (RT, N = 11), combined cardiovascular and resistance training (CT, N = 16) or a control (C, N = 15) group. The training groups participated in an 8-month supervised training program (training three days/week) followed by a 3-month detraining period, while the control group participated only in measurements. Body composition, blood pressure, performance-related variables (aerobic capacity (VO 2max ), muscle strength, flexibility) and blood redox status-related parameters (thiobarbituric acid reactive substances (TBARS), total antioxidant capacity (TAC), reduced glutathione (GSH), oxidized glutathione (GSSG), catalase activity (CAT), protein carbonyls (PC)) were assessed at the beginning of the study, after 4 and 8 months of training as well as following 1, 2 and 3 months of detraining (DT). CVT induced the most remarkable and pronounced alterations in blood pressure (~9% reduction in systolic blood pressure and ~5% in diastolic blood pressure) and redox status since it had a positive effect on all redox-related variables (ranging from 16 to 137%). RT and CT training affected positively some of the assessed (TAC, CAT and PC) redox-related variables. Performance-related variables retained the positive response of the training, whereas most of the redox status parameters, for all training groups, restored near to the pre-exercise values at the end of the DT period. These results indicate that exercise training has a significant effect on redox status of CAD. Three months of detraining is enough to abolish the exercise-induced beneficial effects on redox status, indicating that for a better antioxidant status, exercise must be a lifetime commitment.",2021,"Performance-related variables retained the positive response of the training, whereas most of the redox status parameters, for all training groups, restored near to the pre-exercise values at the end of the DT period.","['Coronary Artery Disease Patients', 'Sixty coronary artery disease patients', 'CAD patients', 'coronary artery disease (CAD) patients']","['CVT', 'combined exercise training', 'exercise training', 'Cardiovascular, Resistance and Combined Exercise Training', 'supervised training program', 'RT and CT training', 'cardiovascular training (CVT, N = 15), resistance training (RT, N = 11), combined cardiovascular and resistance training (CT, N = 16) or a control (C, N = 15) group']","['redox status of CAD', 'blood pressure', 'systolic blood pressure', 'Body composition, blood pressure, performance-related variables (aerobic capacity (VO 2max ), muscle strength, flexibility) and blood redox status-related parameters (thiobarbituric acid reactive substances (TBARS), total antioxidant capacity (TAC), reduced glutathione (GSH), oxidized glutathione (GSSG), catalase activity (CAT), protein carbonyls (PC', 'assessed (TAC, CAT and PC) redox-related variables', 'Cardiovascular, Performance and Blood Redox Parameters', 'cardiovascular function, physical performance and blood redox status parameters', 'oxidative stress']","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0240912', 'cui_str': 'Congenital vertical talus'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0007227', 'cui_str': 'Cardiovascular function'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}]",,0.00387828,"Performance-related variables retained the positive response of the training, whereas most of the redox status parameters, for all training groups, restored near to the pre-exercise values at the end of the DT period.","[{'ForeName': 'Tryfonas', 'Initials': 'T', 'LastName': 'Tofas', 'Affiliation': 'School of Physical Education and Sport Science, University of Thessaly, 42100 Trikala, Greece.'}, {'ForeName': 'Ioannis G', 'Initials': 'IG', 'LastName': 'Fatouros', 'Affiliation': 'School of Physical Education and Sport Science, University of Thessaly, 42100 Trikala, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Draganidis', 'Affiliation': 'School of Physical Education and Sport Science, University of Thessaly, 42100 Trikala, Greece.'}, {'ForeName': 'Chariklia K', 'Initials': 'CK', 'LastName': 'Deli', 'Affiliation': 'School of Physical Education and Sport Science, University of Thessaly, 42100 Trikala, Greece.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Chatzinikolaou', 'Affiliation': 'School of Physical Education and Sport Science, Democritus University of Thrace, 69100 Komotini, Greece.'}, {'ForeName': 'Charalambos', 'Initials': 'C', 'LastName': 'Tziortzis', 'Affiliation': 'Department of Health Sciences, European University Cyprus 6 Diogenis Str., 2404 Engomi, P.O. Box 22006, 1516, Nicosia, Cyprus.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Panayiotou', 'Affiliation': 'Department of Health Sciences, European University Cyprus 6 Diogenis Str., 2404 Engomi, P.O. Box 22006, 1516, Nicosia, Cyprus.'}, {'ForeName': 'Yiannis', 'Initials': 'Y', 'LastName': 'Koutedakis', 'Affiliation': 'School of Physical Education and Sport Science, University of Thessaly, 42100 Trikala, Greece.'}, {'ForeName': 'Athanasios Z', 'Initials': 'AZ', 'LastName': 'Jamurtas', 'Affiliation': 'School of Physical Education and Sport Science, University of Thessaly, 42100 Trikala, Greece.'}]","Antioxidants (Basel, Switzerland)",['10.3390/antiox10030409'] 2908,33803049,Particle Forming Amorphous Solid Dispersions: A Mechanistic Randomized Pharmacokinetic Study in Humans.,"Amorphous solid dispersions (ASDs) are a promising drug-delivery strategy to overcome poor solubility through formulation. Currently, the understanding of drug absorption mechanisms from ASDs in humans is incomplete. Aiming to gain insights in this matter, we conducted a randomized cross-over design open-label clinical study (NCT03886766) with 16 healthy male volunteers in an ambulatory setting, using micro-dosed efavirenz as a model drug. In three phases, subjects were administered (1) solid ASD of efavirenz 50 mg or (2) dissolved ASD of efavirenz 50 mg or (3) a molecular solution of efavirenz 3 mg (non-ASD) as a control in block-randomized order. Endpoints were the pharmacokinetic profiles (efavirenz plasma concentration vs. time curves) and derived pharmacokinetic parameters thereof ( AUC 0-t , C max , t max , and k a ). Results showed that the dissolved ASD (intervention 2) exhibited properties of a supersaturated solution (compared to aqueous solubility) with rapid and complete absorption of the drug from the drug-rich particles. All interventions showed similar AUC 0-t and were well tolerated by subjects. The findings highlight the potential of particle forming ASDs as an advanced drug-delivery system for poorly soluble drugs and provide essential insights into underlying mechanisms of ASD functioning in humans, partially validating current conceptual models.",2021,All interventions showed similar AUC 0-t and were well tolerated by subjects.,"['16 healthy male volunteers in an ambulatory setting, using micro-dosed', 'Humans']","['Amorphous solid dispersions (ASDs', 'efavirenz 50 mg or (2) dissolved ASD of efavirenz 50 mg or (3) a molecular solution of efavirenz 3 mg (non-ASD', 'efavirenz']","['pharmacokinetic profiles (efavirenz plasma concentration vs. time curves) and derived pharmacokinetic parameters thereof ( AUC 0-t , C max , t max , and k a ']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0332624', 'cui_str': 'Dispersion'}, {'cui': 'C0985716', 'cui_str': 'efavirenz 50 MG'}, {'cui': 'C1549535', 'cui_str': 'Dissolve'}, {'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",16.0,0.0364805,All interventions showed similar AUC 0-t and were well tolerated by subjects.,"[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schittny', 'Affiliation': 'Division of Pharmaceutical Technology, Department of Pharmaceutical Sciences, University of Basel, 4056 Basel, Switzerland.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Waldner', 'Affiliation': 'Division of Pharmaceutical Technology, Department of Pharmaceutical Sciences, University of Basel, 4056 Basel, Switzerland.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Duthaler', 'Affiliation': 'Division of Clinical Pharmacology and Toxicology, Department of Biomedicine, University Hospital Basel and University of Basel, 4056 Basel, Switzerland.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Vorobyev', 'Affiliation': ""Department of Pharmtechnology, Faculty of Advanced Training of Medical Workers, Peoples' Friendship University of Russia (RUDN University), 117198 Moscow, Russia.""}, {'ForeName': 'Rimma', 'Initials': 'R', 'LastName': 'Abramovich', 'Affiliation': ""Department of Pharmtechnology, Faculty of Advanced Training of Medical Workers, Peoples' Friendship University of Russia (RUDN University), 117198 Moscow, Russia.""}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Krähenbühl', 'Affiliation': 'Division of Clinical Pharmacology and Toxicology, Department of Biomedicine, University Hospital Basel and University of Basel, 4056 Basel, Switzerland.'}, {'ForeName': 'Maxim', 'Initials': 'M', 'LastName': 'Puchkov', 'Affiliation': 'Division of Pharmaceutical Technology, Department of Pharmaceutical Sciences, University of Basel, 4056 Basel, Switzerland.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Huwyler', 'Affiliation': 'Division of Pharmaceutical Technology, Department of Pharmaceutical Sciences, University of Basel, 4056 Basel, Switzerland.'}]",Pharmaceutics,['10.3390/pharmaceutics13030401'] 2909,33802944,"Efficacy and Safety of a Novel Mouthpiece for Esophagogastroduodenoscopy: A Multi-Center, Randomized Study.","This randomized trial aimed to compare the safety and efficacy of the GAGLESS mouthpiece for esophagogastroduodenoscopy (EGD) with that of the conventional mouthpiece. In all, 90 participants were divided into the GAGLESS mouthpiece and conventional mouthpiece groups. The primary endpoint was the severity of pain using the visual analog scale (VAS), and secondary endpoints were examination time, past history of endoscopy, success of the procedure, systolic (SBP) and diastolic (DBP) blood pressure, oxygen saturation, pulse rate before and after EGD, and adverse events. Endoscopy was completed in all cases, and no complications were observed. VAS, when passing the scope through the pharynx, was 2.5 ± 2.4 and 2.0 ± 1.9 cm ( p = 0.24) in the conventional and GAGLESS groups, respectively, and that, throughout the examination, was 2.5 ± 2.4 and 1.7 ± 1.5 cm ( p = 0.06), respectively. The difference in blood pressure between the GAGLESS and conventional groups was not significant for SBP ( p = 0.08) and significant for DBP ( p = 0.03). The post-EGD difference in DBP was significantly lower in the GAGLESS group than in the conventional group. The results indicate that GAGLESS mouthpieces had a lower VAS during endoscopy than the conventional mouthpieces, and the changes in blood pressure were smaller with the GAGLESS mouthpiece.",2021,The difference in blood pressure between the GAGLESS and conventional groups was not significant for SBP ( p = 0.08) and significant for DBP ( p = 0.03).,['90 participants were divided into the GAGLESS mouthpiece and conventional mouthpiece groups'],"['Novel Mouthpiece for Esophagogastroduodenoscopy', 'GAGLESS mouthpiece for esophagogastroduodenoscopy (EGD']","['DBP', 'safety and efficacy', 'blood pressure', 'Efficacy and Safety', 'SBP', 'severity of pain using the visual analog scale (VAS), and secondary endpoints were examination time, past history of endoscopy, success of the procedure, systolic (SBP) and diastolic (DBP) blood pressure, oxygen saturation, pulse rate before and after EGD, and adverse events']","[{'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}]","[{'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",90.0,0.0363849,The difference in blood pressure between the GAGLESS and conventional groups was not significant for SBP ( p = 0.08) and significant for DBP ( p = 0.03).,"[{'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Ikebuchi', 'Affiliation': 'Division of Medicine and Clinical Science, Department of Multidisciplinary Internal Medicine, Faculty of Medicine, Tottori University, Tottori 683-8504, Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Matsumoto', 'Affiliation': 'Division of Medicine and Clinical Science, Department of Multidisciplinary Internal Medicine, Faculty of Medicine, Tottori University, Tottori 683-8504, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Ueda', 'Affiliation': 'Irisawa Medical Clinic, Shimane 690-0025, Japan.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': 'Division of Medicine and Clinical Science, Department of Multidisciplinary Internal Medicine, Faculty of Medicine, Tottori University, Tottori 683-8504, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Kurumi', 'Affiliation': 'Division of Medicine and Clinical Science, Department of Multidisciplinary Internal Medicine, Faculty of Medicine, Tottori University, Tottori 683-8504, Japan.'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Onoyama', 'Affiliation': 'Division of Medicine and Clinical Science, Department of Multidisciplinary Internal Medicine, Faculty of Medicine, Tottori University, Tottori 683-8504, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Takeda', 'Affiliation': 'Division of Medicine and Clinical Science, Department of Multidisciplinary Internal Medicine, Faculty of Medicine, Tottori University, Tottori 683-8504, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Yoshida', 'Affiliation': 'Division of Medicine and Clinical Science, Department of Multidisciplinary Internal Medicine, Faculty of Medicine, Tottori University, Tottori 683-8504, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Kawaguchi', 'Affiliation': 'Division of Medicine and Clinical Science, Department of Multidisciplinary Internal Medicine, Faculty of Medicine, Tottori University, Tottori 683-8504, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Yashima', 'Affiliation': 'Division of Medicine and Clinical Science, Department of Multidisciplinary Internal Medicine, Faculty of Medicine, Tottori University, Tottori 683-8504, Japan.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Division of Medicine of Sensory and Motor Organs, Faculty of Medicine, Tottori University, Tottori 683-8504, Japan.'}, {'ForeName': 'Ryu', 'Initials': 'R', 'LastName': 'Imamoto', 'Affiliation': 'Department of Gastroenterology, Yasugi Municipal Hospital, Shimane 692-0404, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Noma', 'Affiliation': 'The Institute of Statistical Mathematics, Tokyo 190-8562, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Ueki', 'Affiliation': 'Advanced Medicine, Innovation and Clinical Research Center, Tottori University Hospital, Tottori 683-8504, Japan.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Isomoto', 'Affiliation': 'Department of Gastroenterology, Yasugi Municipal Hospital, Shimane 692-0404, Japan.'}]","Diagnostics (Basel, Switzerland)",['10.3390/diagnostics11030538'] 2910,33802399,Treatment with Oral Ondansetron for Ultramarathon-Associated Nausea: The TOO FUN Study.,"Nausea and vomiting are common for runners during ultramarathons and often contribute to non-finishes. We aimed to determine the efficacy of ondansetron, a commonly used antiemetic, to treat nausea and vomiting in runners during an ultramarathon. Runners who had a previous history of frequent nausea or vomiting during races and entered in 160, 80, and 55 km ultramarathons in 2018 and 2019 were randomized in a double-blind fashion to 4 mg ondansetron or placebo capsules to use if they developed nausea or vomiting during the race with the ability to take three additional doses. Study participants completed a post-race online survey to assess medication use and efficacy. Of 62 study participants, 31 took either ondansetron (20) or placebo (11). In this small study, there were no group differences in those reporting any improvement in nausea and vomiting ( p = 0.26) or in the amount of improvement ( p = 0.15). We found no evidence that ondansetron capsules improve nausea and vomiting during ultramarathons.",2021,"In this small study, there were no group differences in those reporting any improvement in nausea and vomiting ( p = 0.26) or in the amount of improvement ( p = 0.15).","['Of 62 study participants, 31 took either', 'runners during an ultramarathon', 'Runners who had a previous history of frequent nausea or vomiting during races and entered in 160, 80, and 55 km ultramarathons in 2018 and 2019']","['ondansetron (20) or placebo', 'ondansetron or placebo', 'Oral Ondansetron', 'ondansetron']","['Nausea and vomiting', 'nausea or vomiting', 'nausea and vomiting', 'Nausea']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",62.0,0.528948,"In this small study, there were no group differences in those reporting any improvement in nausea and vomiting ( p = 0.26) or in the amount of improvement ( p = 0.15).","[{'ForeName': 'Andrew V', 'Initials': 'AV', 'LastName': 'Pasternak', 'Affiliation': 'Silver Sage Center for Family Medicine, Reno, NV 89521, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fiore', 'Affiliation': 'Department of Family and Community Medicine, Reno School of Medicine, University of Nevada, Reno, NV 89557, USA.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Islas', 'Affiliation': 'Department of Family and Community Medicine, Reno School of Medicine, University of Nevada, Reno, NV 89557, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Toti', 'Affiliation': 'Reno School of Medicine, University of Nevada, Reno, NV 89557, USA.'}, {'ForeName': 'Martin D', 'Initials': 'MD', 'LastName': 'Hoffman', 'Affiliation': 'Physical Medicine and Rehabilitation Service, Department of Veterans Affairs, Northern California Health Care System, Sacramento, CA 95655, USA.'}]","Sports (Basel, Switzerland)",['10.3390/sports9030035'] 2911,33813536,Efficacy of a Simulation Program to Improve Clinical Judgment and Clinical Competence Among Graduate Nurses.,"AIM This two-group feasibility study tested the efficacy of a four-scenario simulation program to improve clinical judgment and clinical competence among graduate nurses. BACKGROUND Clinical judgment and clinical competence are underdeveloped among new-to-practice nurses. METHOD Clinical judgment was compared between the intervention group (n = 17) and a control group (n = 26) in the practice setting at two time points. RESULTS The simulation program had a large effect on the intervention group's clinical judgment (η2 = .143) and clinical competence (η2 = .153). There were no statistically significant differences for each outcome at baseline as compared to the final scenario for the intervention group. There was no statistical significance between the intervention and control groups in clinical judgment in the practice setting at each measurement time. CONCLUSION Replication of the study with a randomized controlled trial and large sample size is warranted.",2021,The simulation program had a large effect on the intervention group's clinical judgment (η2 = .143) and clinical competence (η2 = .153).,"['Graduate Nurses', 'graduate nurses']","['Simulation Program', 'four-scenario simulation program']",['clinical judgment and clinical competence'],"[{'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0008956', 'cui_str': 'Competence, Clinical'}]",26.0,0.0808198,The simulation program had a large effect on the intervention group's clinical judgment (η2 = .143) and clinical competence (η2 = .153).,"[{'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': 'Cantrell', 'Affiliation': 'About the Authors The authors are faculty at the M. Louise Fitzpatrick College of Nursing, Villanova University, Villanova, Pennsylvania. Mary Ann Cantrell, PhD, RN, CNE, ANEF, FAAN, is director, PhD program, and professor. Bette Mariani, PhD, RN, ANEF, is vice dean for academic affairs and associate professor. Evelyn Lengetti, PhD, RN-BC, is assistant dean of continuing education. This study was supported by the NLN Donnelly Corcoran Research Award and the Center for Nursing Research, M. Louise Fitzpatrick College of Nursing, Villanova University. Dr. Mariani, Nursing Education Perspectives Research Brief editor, did not participate in the review or decision for this article. For more information, contact Dr. Cantrell at mary.ann.cantrell@villanova.edu.'}, {'ForeName': 'Bette', 'Initials': 'B', 'LastName': 'Mariani', 'Affiliation': ''}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Lengetti', 'Affiliation': ''}]",Nursing education perspectives,['10.1097/01.NEP.0000000000000805'] 2912,33813244,"Lower versus standard sucrose dose for treating hypoglycemia in patients with type 1 diabetes mellitus in therapy with predictive low glucose suspend (PLGS) augmented insulin pumps: A randomized crossover trial in Santiago, Chile.","BACKGROUND AND AIMS Recommended hypoglycemia treatment in adults with T1D consists of 15 g of rapid absorption carbohydrates. We aimed to evaluate the response to fewer carbohydrates for treating hypoglycemia in patients with T1D on insulin pumps with predictive suspension technology (PLGS). METHODS T1D patients on insulin pumps with PLGS were randomized to receive 10 or 15 g of sucrose per hypoglycemia for two weeks (S10 and S15 groups, respectively) when capillary blood glucose (BG) was <70 mg/dL, with crossover after two weeks. Evolution of capillary BG, active insulin, and suspension time were assessed. RESULTS 59 hypoglycemic episodes were analyzed, 33 in S10 and 26 in S15. Baseline BG in S10 was 54.3 ± 7.7 mg/dL versus 56.9 ± 8.8 in S15 (p = 0,239). Active insulin, present in 85% of the episodes, and PLGS suspension time were similar between groups. BG at 15 min was 77 mg/dL in S10 and 95 mg/dL in S15 (p = 0.0007). In S10, 21% of the episodes required to repeat the treatment after 15 min compared with none on S15, with a RR of 0,79 (95% CI 0.66, 0.940, p = 0,014) for successfully treating the episode. Sensor glucose was significantly different from BG at the moment of the hypoglycemia and control 15 min after treatment. No severe hypoglycemia and no rebound hyperglycemia occurred in neither group. CONCLUSIONS A hypoglycemia treatment protocol with a lower dose of sucrose might be insufficient despite PLGS technology. Our data suggest that standard doses of sucrose should still be recommended.",2021,Sensor glucose was significantly different from BG at the moment of the hypoglycemia and control 15 min after treatment.,"['adults with T1D consists of 15\xa0g of rapid absorption carbohydrates', 'patients with type 1 diabetes mellitus in therapy with predictive low glucose suspend (PLGS) augmented insulin pumps', 'T1D patients on insulin pumps with PLGS', 'patients with T1D on insulin pumps with predictive suspension technology (PLGS']",['standard sucrose'],"['Sensor glucose', 'PLGS suspension time', 'capillary BG, active insulin, and suspension time', 'severe hypoglycemia and no rebound hyperglycemia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0860801', 'cui_str': 'Glucose low'}, {'cui': 'C0038959', 'cui_str': 'Suspending Agents'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}]","[{'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0342314', 'cui_str': 'Dawn phenomenon'}]",,0.0818749,Sensor glucose was significantly different from BG at the moment of the hypoglycemia and control 15 min after treatment.,"[{'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Grassi', 'Affiliation': 'Departament of Nutrition, Diabetes and Metabolism, School of Medicine. Pontificia Universidad Católica de Chile, Santiago, Chile. Electronic address: bagrassi@gmail.com.'}, {'ForeName': 'María Teresa', 'Initials': 'MT', 'LastName': 'Onetto', 'Affiliation': 'Departament of Nutrition, Diabetes and Metabolism, School of Medicine. Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Yazmín', 'Initials': 'Y', 'LastName': 'Zapata', 'Affiliation': 'Departament of Nutrition, Diabetes and Metabolism, School of Medicine. Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Jofré', 'Affiliation': 'Departament of Nutrition, Diabetes and Metabolism, School of Medicine. Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Guadalupe', 'Initials': 'G', 'LastName': 'Echeverría', 'Affiliation': 'Departament of Nutrition, Diabetes and Metabolism, School of Medicine. Pontificia Universidad Católica de Chile, Santiago, Chile; Center of Molecular Nutrition and Chronic Diseases. School of Medicine. Pontificia Universidad Católica de Chile, Santiago, Chile.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2021.03.017'] 2913,33813183,"Effect of a theory-driven educational intervention on the level of knowledge, attitudes, and assessment practices regarding breakthrough cancer pain (BTCP) management among medical nurses in Hong Kong.","PURPOSE To examine the effect of an educational intervention intended to improve medical nurses' adherence to breakthrough cancer pain (BTCP) assessment practices and their level of knowledge, attitudes and perceived assessment practices regarding BTCP management. METHODS Nurses working in a regional hospital were recruited to this quasi-experimental study. The intervention group received a 3-h educational workshop and one session of individual clinical instruction, whilst the control group did not receive any intervention. Chart audits were performed to examine adherence to BTCP assessment practices as the primary outcome. A self-developed questionnaire was used to measure nurses' knowledge, attitudes and perceived assessment practices regarding BTCP management as the secondary outcomes. The chi-square or Fisher's exact test was used to compare the rate of adherence to BTCP assessment practices between groups. A generalised estimating equation was used to compare changes in knowledge, attitudes, and perceived assessment practices between groups over time. RESULTS One hundred and five nurses completed the study. The chart audits revealed a significantly higher rate of adherence to BTCP assessment practices in the intervention group after the intervention (p < .05). The intervention group exhibited significant positive changes in scores for knowledge (β = 25.49, p < .001), attitude (β = 0.98 to 2.81, p < .01), and their perceived assessment practices (β = 1.33 to 3.14, p < .002) when compared with the control group. CONCLUSIONS This theory-driven educational intervention significantly improved the medical nurses' adherence to BTCP assessment practices and their level of knowledge attitudes and perceived assessment practices regarding BTCP management.",2021,"The intervention group exhibited significant positive changes in scores for knowledge (β = 25.49, p < .001), attitude (β = 0.98 to 2.81, p < .01), and their perceived assessment practices (β = 1.33 to 3.14, p < .002) when compared with the control group. ","['medical nurses in Hong Kong', 'One hundred and five nurses completed the study', 'Nurses working in a regional hospital were recruited to this quasi-experimental study']","['educational intervention', 'theory-driven educational intervention', '3-h educational workshop and one session of individual clinical instruction, whilst the control group did not receive any intervention']","['level of knowledge, attitudes, and assessment practices regarding breakthrough cancer pain (BTCP) management', 'rate of adherence to BTCP assessment practices', 'scores for knowledge']","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2721580', 'cui_str': 'Breakthrough cancer pain'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",105.0,0.0133184,"The intervention group exhibited significant positive changes in scores for knowledge (β = 25.49, p < .001), attitude (β = 0.98 to 2.81, p < .01), and their perceived assessment practices (β = 1.33 to 3.14, p < .002) when compared with the control group. ","[{'ForeName': 'Carman Y L', 'Initials': 'CYL', 'LastName': 'Kwok', 'Affiliation': 'Haven of Hope Sister Annie Skau Holistic Centre, Hong Kong, SAR, China.'}, {'ForeName': 'Dorothy N S', 'Initials': 'DNS', 'LastName': 'Chan', 'Affiliation': 'The Nethersole School of Nursing, The Chinese University of Hong Kong, Hong Kong, SAR, China. Electronic address: dorothycns@cuhk.edu.hk.'}, {'ForeName': 'Winnie K W', 'Initials': 'WKW', 'LastName': 'So', 'Affiliation': 'The Nethersole School of Nursing, The Chinese University of Hong Kong, Hong Kong, SAR, China.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2021.101945'] 2914,33813084,"Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Phase-II Trial: AdrenoMedullin for Ischemic Stroke Study.","OBJECTIVES Adrenomedullin (AM), a vasoactive peptide, has strong anti-inflammatory and angiogenic properties, which have been reported to ameliorate the consequences of ischemic stroke in several animal models. After a phase I study in healthy volunteers, two phase II trials of AM for inflammatory bowel diseases have been recently completed. The current AdrenoMedullin For Ischemic Stroke (AMFIS) study aims to assess the safety and efficacy of AM in patients with acute ischemic stroke. MATERIALS AND METHODS The AMFIS study is an investigator-initiated, randomized, double-blind, phase-II trial. AM or placebo will be administered to patients with non-cardioembolic ischemic stroke within 24 h after stroke onset. In the first cohort of the AMFIS study, patients will be randomly allocated to the investigation treatment A (30 μg/kg of AM in total for 7 days, n = 20) or placebo group (n = 10). In the second cohort, patients will be assigned to the investigation treatment B (56 μg/kg of AM in total for 7 days, n = 20) or placebo group (n = 10). RESULTS Serious adverse events related to the protocol treatment will be evaluated as the primary outcome. All adverse events will be analyzed as the secondary outcome. Regarding efficacy endpoints, the change in National Institutes of Health Stroke Scale and modified Rankin Scale scores will be compared between investigation treatment and placebo groups. CONCLUSIONS AM is expected to be a safe and effective treatment for ischemic stroke.",2021,"After a phase I study in healthy volunteers, two phase II trials of AM for inflammatory bowel diseases have been recently completed.","['healthy volunteers', 'patients with acute ischemic stroke', 'patients with non-cardioembolic ischemic stroke within 24\xa0h after stroke onset']","['Placebo', 'placebo', 'AM', 'AM or placebo']","['change in National Institutes of Health Stroke Scale and modified Rankin Scale scores', 'safety and efficacy']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0215825', 'cui_str': 'ADM(1-52)'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.52758,"After a phase I study in healthy volunteers, two phase II trials of AM for inflammatory bowel diseases have been recently completed.","[{'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Yoshimoto', 'Affiliation': 'Department of Neurology, National Cerebral and Cardiovascular Center, 6-1 Kishibe-Shimmachi, Suita, Osaka 564-8565, Japan; Department of Clinical Neuroscience and Therapeutics, Hiroshima University, Hiroshima, Japan. Electronic address: yoshimototakeshi1982@ncvc.go.jp.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Saito', 'Affiliation': 'Department of Neurology, National Cerebral and Cardiovascular Center, 6-1 Kishibe-Shimmachi, Suita, Osaka 564-8565, Japan; Department of Pediatric Dentistry, Osaka University Graduate School of Dentistry, Suita, Japan. Electronic address: saitou.satoshi.43m@kyoto-u.jp.'}, {'ForeName': 'Katsuhiro', 'Initials': 'K', 'LastName': 'Omae', 'Affiliation': 'Department of Data Science, National Cerebral and Cardiovascular Center, Suita, Japan. Electronic address: k.omae@ncvc.go.jp.'}, {'ForeName': 'Yorito', 'Initials': 'Y', 'LastName': 'Hattori', 'Affiliation': 'Department of Neurology, National Cerebral and Cardiovascular Center, 6-1 Kishibe-Shimmachi, Suita, Osaka 564-8565, Japan. Electronic address: yoh2019@ncvc.go.jp.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Fukuma', 'Affiliation': 'Department of Neurology, National Cerebral and Cardiovascular Center, 6-1 Kishibe-Shimmachi, Suita, Osaka 564-8565, Japan. Electronic address: kazblues77@ncvc.go.jp.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Kitamura', 'Affiliation': 'Division of Circulatory and Body Fluid Regulation, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan. Electronic address: kazuokit@med.miyazaki-u.ac.jp.'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Kakuta', 'Affiliation': 'Department of Data Science, National Cerebral and Cardiovascular Center, Suita, Japan. Electronic address: r_kakuta@ncvc.go.jp.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Kita', 'Affiliation': 'Division of Circulatory and Body Fluid Regulation, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan. Electronic address: toshihiro_kita@med.miyazaki-u.ac.jp.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Maruyama', 'Affiliation': 'Department of Clinical Neuroscience and Therapeutics, Hiroshima University, Hiroshima, Japan. Electronic address: hmaru@hiroshima-u.ac.jp.'}, {'ForeName': 'Haruko', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Data Science, National Cerebral and Cardiovascular Center, Suita, Japan. Electronic address: harukoya@ncvc.go.jp.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ihara', 'Affiliation': 'Department of Neurology, National Cerebral and Cardiovascular Center, 6-1 Kishibe-Shimmachi, Suita, Osaka 564-8565, Japan. Electronic address: ihara@ncvc.go.jp.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2021.105761'] 2915,33812750,"Family Economic Empowerment, Family Social Support, and Sexual Risk-Taking Behaviors Among Adolescents Living With HIV in Uganda: The Suubi+Adherence Study.","PURPOSE This study examined the effect of a family economic empowerment (EE) intervention and family support on sexual risk-taking behaviors among adolescents living with HIV in rural Uganda. METHODS We used data from the Suubi + Adherence study, a longitudinal cluster randomized clinical trial of 702 adolescents living with HIV aged 10-16 years. Participants were randomly assigned to either the control arm (n = 358) receiving bolstered standard of care or a treatment arm (n = 344) receiving bolstered standard of care plus the family EE intervention. We used mixed-effects models to examine the effect of the EE intervention and family support on sexual risk-taking behaviors at the baseline, 12 months, and 24 months after intervention initiation. RESULTS Adolescents in both the intervention and control groups did not differ significantly in their sexual risk-taking attitudes at the baseline and over the 24-month follow-up period. Higher levels of caregiver social support were significantly associated with a decrease in attitudes toward sexual risk-taking (ß = -.40, 95%CI = -.51, -.29). More frequent parent-child communication was significantly associated with increased negative sexual risk-taking attitudes (ß = .21, 95%CI = .16, .26). CONCLUSIONS Although we find no direct relationship between family EE and attitudes related to sexual risk-taking behaviors, we find that a supportive family environment can promote positive attitudes related to sexual risk-taking behaviors. The effectiveness of sexual risk reduction interventions would be enhanced by engaging families and strengthening supportive relationships between adolescents and their caregivers.",2021,"RESULTS Adolescents in both the intervention and control groups did not differ significantly in their sexual risk-taking attitudes at the baseline and over the 24-month follow-up period.","['adolescents living with HIV in rural Uganda', '702 adolescents living with HIV aged 10-16\xa0years', 'Adolescents Living With HIV in Uganda', 'adolescents and their caregivers']","['control arm (n\xa0= 358) receiving bolstered standard of care or a treatment arm (n\xa0= 344) receiving bolstered standard of care plus the family EE intervention', 'family economic empowerment (EE) intervention and family support', 'sexual risk reduction interventions']","['negative sexual risk-taking attitudes', 'sexual risk-taking attitudes', 'attitudes toward sexual risk-taking (ß', 'sexual risk-taking behaviors', 'Higher levels of caregiver social support', 'Family Economic Empowerment, Family Social Support, and Sexual Risk-Taking Behaviors']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0150232', 'cui_str': 'Family support'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0035651', 'cui_str': 'Risk-Taking'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}]",702.0,0.0586898,"RESULTS Adolescents in both the intervention and control groups did not differ significantly in their sexual risk-taking attitudes at the baseline and over the 24-month follow-up period.","[{'ForeName': 'Thembekile', 'Initials': 'T', 'LastName': 'Shato', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Brown School, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Proscovia', 'Initials': 'P', 'LastName': 'Nabunya', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Brown School, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Byansi', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Brown School, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Ucheoma', 'Initials': 'U', 'LastName': 'Nwaozuru', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Brown School, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Moses', 'Initials': 'M', 'LastName': 'Okumu', 'Affiliation': 'School of Social Work, University of North Carolina-Chapel, Chapel Hill, North Carolina.'}, {'ForeName': 'Massy', 'Initials': 'M', 'LastName': 'Mutumba', 'Affiliation': 'Department of Health Behavior and Biological Sciences, University of Michigan School of Nursing, Ann Arbor, Michigan.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Brathwaite', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Brown School, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Damulira', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Masaka, Uganda.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Namuwonge', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Masaka, Uganda.'}, {'ForeName': 'Ozge Sensoy', 'Initials': 'OS', 'LastName': 'Bahar', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Brown School, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Torsten B', 'Initials': 'TB', 'LastName': 'Neilands', 'Affiliation': 'Division of Prevention Science, Center for AIDS Prevention Studies (CAPS), Department of Medicine, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Brown School, Washington University in St. Louis, St. Louis, Missouri. Electronic address: fms1@wustl.edu.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2021.02.005'] 2916,33812743,"A randomized, controlled trial comparing the immunogenicity and safety of a 23-valent pneumococcal polysaccharide vaccination to a repeated dose 13-valent pneumococcal conjugate vaccination in adult liver transplant recipients.","BACKGROUND Solid organ transplant (SOT) patients are at significant risk for invasive pneumococcal disease. The optimal pneumococcal vaccination strategy for SOT patients is not known. METHODS The potential adult liver transplant recipients were randomised into two arms: to receive a 23-valent pneumococcal polysaccharide vaccine (PPV23) before the transplantation or to receive a 13-valent pneumococcal conjugate vaccine (PCV13) before the transplantation and a second dose of PCV13 six months after the transplantation. Serotype-specific antibody concentrations and opsonophagocytic activity (OPA) were measured before and after the first vaccination (visits V1,V2) and six and seven months after the transplantation, e.g. before and after the second PCV13 (visits V3,V4). RESULTS Out of 47 patients, 19 (PCV13 arm) and 17 (PPV23 arm) received a liver transplant and all these patients completed the study (36/47, 76,6%). Each vaccine schedule elicited a good immune response. At V2, the geometric mean concentrations (GMĆs) of antibodies for serotypes 6A, 7F and 23F, and the geometric mean titers (GMT́s) of OPA for serotypes 4, 6A, 6B and 23F were significantly higher for PCV13, but the proportions of patients reaching OPA cut-off ≥ 8 or ELISA cut-off ≥ 1.0 µg/ml did not differ between the arms. At V3 the antibody concentrations and the OPA had declined to baseline in both arms. The second PCV13 vaccination elicited an immune response. There was no difference in adverse events. No vaccine-related allograft rejection was detected. CONCLUSIONS The immunogenicity of PPV23 and PCV13 was comparable in this patient material, but the seroresponses waned after transplantation. The second dose of PCV13 restored the immune responses and was well tolerated.",2021,"Serotype-specific antibody concentrations and opsonophagocytic activity (OPA) were measured before and after the first vaccination (visits V1,V2) and six and seven months after the transplantation, e.g. before and after the second PCV13 (visits V3,V4). ","['potential adult liver transplant recipients', 'SOT patients', 'adult liver transplant recipients']","['23-valent pneumococcal polysaccharide vaccination', '23-valent pneumococcal polysaccharide vaccine (PPV23) before the transplantation or to receive a 13-valent pneumococcal conjugate vaccine (PCV13', 'PCV13', 'Solid organ transplant ']","['allograft rejection', 'tolerated', 'immunogenicity and safety', 'immunogenicity of PPV23 and PCV13', 'Serotype-specific antibody concentrations and opsonophagocytic activity (OPA', 'geometric mean concentrations (GMĆs) of antibodies for serotypes 6A, 7F and 23F, and the geometric mean titers (GMT́s) of OPA for serotypes 4, 6A, 6B and 23F', 'adverse events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0455647', 'cui_str': 'H/O: liver recipient'}, {'cui': 'C0730400', 'cui_str': 'Solid organ transplant'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C0032594', 'cui_str': 'Polysaccharide'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0961101', 'cui_str': '23-valent pneumococcal capsular polysaccharide vaccine'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C3152625', 'cui_str': 'Pneumococcal 13-valent conjugate vaccine'}, {'cui': 'C0730400', 'cui_str': 'Solid organ transplant'}]","[{'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",47.0,0.179505,"Serotype-specific antibody concentrations and opsonophagocytic activity (OPA) were measured before and after the first vaccination (visits V1,V2) and six and seven months after the transplantation, e.g. before and after the second PCV13 (visits V3,V4). ","[{'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Eriksson', 'Affiliation': 'HUH Inflammation Center, Division of Infectious Diseases of Helsinki University Hospital and Helsinki University, Finland. Electronic address: mari.eriksson@hus.fi.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Käyhty', 'Affiliation': 'National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Lahdenkari', 'Affiliation': 'National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Mäkisalo', 'Affiliation': 'HUH Abdominal Center, Division of Liver Diseases and Transplantation, Helsinki University Hospital and Helsinki University, Finland.'}, {'ForeName': 'Veli-Jukka', 'Initials': 'VJ', 'LastName': 'Anttila', 'Affiliation': 'HUH Inflammation Center, Division of Infectious Diseases of Helsinki University Hospital and Helsinki University, Finland.'}]",Vaccine,['10.1016/j.vaccine.2021.03.063'] 2917,33812261,An evaluation of the effect of ozone therapy on tissues surrounding dental implants.,"BACKGROUND Dental implant surgery despite its growing popularity poses several challenges like include tissue inflammation, pain discomfort and tissue injury. OBJECTIVE To evaluate the effect of ozone therapy on inflammation, pain and wound healing after implant surgery. METHODS A clinical study was conducted on 60 systematically healthy patients- 30 patients treated with ozone (Experimental group) and 30 patients without ozone treatment (control group). In the control group osteotomy procedure was performed with saline irrigation and in the experimental group irrigation was done with ozonated water at 25 µg/mL concentration, along with ozone gas. Clinical assessment was done by evaluating C-reactive Protein (CRP) for inflammation, pain using Visual Analogue Scale (VAS) score and tissue wound healing using wound healing index. Side effects, if any, were noted. RESULTS Postoperative increment in CRP levels was 0.10 and 0.63 mg/dl in Experimental and control groups respectively (p < 0.001). At 24-hr, 48-hr and 7 day post-operative intervals mean VAS scores for pain were significantly higher in Control group as compared to that in Experimental Group (p < 0.001). At day 7, mean VAS scores for pain were 3.50 ± 0.63 and 37.70 ± 4.17 in Experimental and Control groups respectively (p < 0.001). Mean tissue healing indices were significantly higher on Day 7 and Day 14 in Experimental Group (4.23 ± 0.43 and 4.97 ± 0.18) as compared to that in control group (3.07 ± 0.45 and 4.03 ± 0.18) (p < 0.001). No potential side effects were noted in either of two groups. CONCLUSION Ozone therapy accelerated the tissue wound healing, minimized tissue inflammation and decreased pain.",2021,"At 24-hr, 48-hr and 7 day post-operative intervals mean VAS scores for pain were significantly higher in Control group as compared to that in Experimental Group (p < 0.001).","['tissues surrounding dental implants', '60 systematically healthy patients- 30 patients treated with ozone (Experimental group) and 30 patients without ozone treatment (control group']","['saline irrigation', 'ozone therapy']","['CRP levels', 'inflammation, pain and wound healing', 'VAS scores for pain', 'tissue wound healing, minimized tissue inflammation and decreased pain', 'potential side effects', 'C-reactive Protein (CRP) for inflammation, pain using Visual Analogue Scale (VAS) score and tissue wound healing using wound healing index', 'mean VAS scores for pain', 'Mean tissue healing indices']","[{'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1282914', 'cui_str': 'Circumscribed'}, {'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C4727847', 'cui_str': 'Ozone therapy'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",60.0,0.0131958,"At 24-hr, 48-hr and 7 day post-operative intervals mean VAS scores for pain were significantly higher in Control group as compared to that in Experimental Group (p < 0.001).","[{'ForeName': 'Abhinav', 'Initials': 'A', 'LastName': 'Shekhar', 'Affiliation': 'Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow, India.'}, {'ForeName': 'Shitij', 'Initials': 'S', 'LastName': 'Srivastava', 'Affiliation': 'Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow, India.'}, {'ForeName': 'Love', 'Initials': 'L', 'LastName': 'Kumar Bhati', 'Affiliation': 'Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow, India.'}, {'ForeName': 'Anshuman', 'Initials': 'A', 'LastName': 'Chaturvedi', 'Affiliation': 'Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow, India.'}, {'ForeName': 'Shivesh', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow, India.'}, {'ForeName': 'Bhaskar', 'Initials': 'B', 'LastName': 'Agarwal', 'Affiliation': ""Department of Prosthodontics, King George's Medical University, Lucknow, India. Electronic address: bhaskaragarwal2@gmail.com.""}, {'ForeName': 'Khitiz', 'Initials': 'K', 'LastName': 'Arora', 'Affiliation': 'APS Active Research Group, Lucknow, India.'}]",International immunopharmacology,['10.1016/j.intimp.2021.107588'] 2918,33245533,Mirabegron Add-On Therapy to Tamsulosin in Men with Overactive Bladder: Post Hoc Analyses of Efficacy from the MATCH Study.,"INTRODUCTION MATCH was a randomized, double-blind, placebo-controlled study enrolling Japanese and Korean men aged ≥ 40 years who still had overactive bladder (OAB) symptoms while receiving tamsulosin. After a 4-week single-blind screening period in which patients received placebo and tamsulosin, patients were randomized to mirabegron 50 mg + tamsulosin or placebo + tamsulosin for 12 weeks (n = 568). This post hoc analysis investigated the proportion of treatment responders for each treatment group and for subgroups stratified by age based on voiding diaries and patient-reported outcomes (PROs). METHODS Responders were defined as those achieving normalization or clinically meaningful improvements in efficacy, or clinically important differences in PROs [≥ 10-point improvement in OAB questionnaire (OAB-q) symptom bother or total health-related quality of life (HRQoL) subscales at end of treatment (EoT; minimally important difference [MID]) or OAB symptom score (OABSS) total score decreased by ≥ 3 points at EoT [minimally clinically important change (MCIC)]]. RESULTS At EoT, micturition frequency normalization was achieved by 30.7% of tamsulosin + mirabegron patients and 18.6% of tamsulosin + placebo patients. Normalization of urgency and incontinence was 19.1% and 60.7% for tamsulosin + mirabegron and 18.2% and 60.0% for tamsulosin + placebo. Normalization of OAB symptoms based on OABSS was 17.1% for tamsulosin + mirabegron and 14.5% for tamsulosin + placebo. Higher proportions of patients in the mirabegron add-on group versus the placebo group reported clinically meaningful improvements in micturitions, urgency, and incontinence and in MCIC for OABSS and MID for the OAB-q subscales. Double- and triple-responder findings were as predicted by the results of single-responder analyses. These results were mirrored in the age groups using cut-offs of 65 and 75 years. CONCLUSION Mirabegron therapy added on to tamsulosin resulted in a higher frequency of responders in terms of normalization (e.g., micturition frequency normalization), clinically meaningful improvements in efficacy (e.g., ≥ 50% decrease in urgency), and minimally important changes in PROs (e.g., MCIC in OABSS). TRIAL REGISTRATION ClinicalTrials.gov identifier, NCT02656173.",2021,"Mirabegron therapy added on to tamsulosin resulted in a higher frequency of responders in terms of normalization (e.g., micturition frequency normalization), clinically meaningful improvements in efficacy (e.g., ≥ 50% decrease in urgency), and minimally important changes in PROs (e.g., MCIC in OABSS). ","['40\xa0years who still had overactive bladder (OAB) symptoms while receiving', 'enrolling Japanese and Korean men aged\u2009≥', 'Men with Overactive Bladder']","['tamsulosin', 'placebo', 'Tamsulosin', 'tamsulosin\u2009+\u2009placebo', 'mirabegron 50\xa0mg\u2009+\u2009tamsulosin or placebo\u2009+\u2009tamsulosin', 'tamsulosin\u2009', 'placebo and tamsulosin']","['micturition frequency normalization', 'Normalization of OAB symptoms based on OABSS', 'urgency', 'micturitions, urgency, and incontinence and in MCIC for OABSS and MID for the OAB-q subscales', 'Normalization of urgency and incontinence', 'PROs [≥\u200910-point improvement in OAB questionnaire (OAB-q) symptom bother or total health-related quality of life (HRQoL) subscales at end of treatment (EoT; minimally important difference [MID]) or OAB symptom score (OABSS) total score decreased by\u2009≥\u20093 points at EoT [minimally clinically important change (MCIC']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3474335', 'cui_str': 'mirabegron 50 MG'}]","[{'cui': 'C0042023', 'cui_str': 'Increased frequency of urination'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",,0.210468,"Mirabegron therapy added on to tamsulosin resulted in a higher frequency of responders in terms of normalization (e.g., micturition frequency normalization), clinically meaningful improvements in efficacy (e.g., ≥ 50% decrease in urgency), and minimally important changes in PROs (e.g., MCIC in OABSS). ","[{'ForeName': 'Hidehiro', 'Initials': 'H', 'LastName': 'Kakizaki', 'Affiliation': 'Asahikawa Medical University, Asahikawa, Japan.'}, {'ForeName': 'Kyu-Sung', 'Initials': 'KS', 'LastName': 'Lee', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Katou', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan. daisuke.katou@astellas.com.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Yamamoto', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Budiwan', 'Initials': 'B', 'LastName': 'Sumarsono', 'Affiliation': 'Astellas Pharma, Singapore, Singapore.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Uno', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Yamaguchi', 'Affiliation': 'Division of Bioengineering and LUTD Research, Nihon University School of Engineering, Koriyama, Japan.'}]",Advances in therapy,['10.1007/s12325-020-01517-5'] 2919,33812809,Bridging the postpartum gap: Best practices for training of obstetric patient navigators.,"The postpartum period represents a critical window of opportunity to improve maternal short- and long-term health, including optimizing postpartum recovery, providing effective contraception, caring for mood disorders, managing weight, supporting lactation, initiating preventive care, and promoting cardiometabolic health. However, inadequate postpartum care, especially for individuals facing social and structural barriers, is common in the United States and contributes to suboptimal health outcomes with lasting consequences. Patient navigation is a patient-centered intervention that uses trained personnel to identify financial, cultural, logistical, and educational obstacles to effective health care, and to mitigate these barriers in order to facilitate comprehensive and timely access to needed health services. Given emerging evidence suggesting patient navigation may be a promising method to improve health among postpartum individuals, our team developed a postpartum patient navigator training guide to be used in the Navigating New Motherhood 2 (NNM2) and other obstetric navigation programs. NNM2 is a randomized trial exploring whether patient navigation by a trained, lay postpartum navigator for low-income individuals can improve health and patient-reported outcomes during and after the postpartum period. Hiring and training patient navigators without health professional degrees are integral components of initiating a navigation program. Yet, patient navigator training is highly variable, and no guidelines regarding key elements in such a training program exist for obstetrics specifically. Thus, this paper aims to describe the core principles, content, and rationale for each element in a comprehensive postpartum patient navigator training program. Training should be centered around six core elements: 1) principles of patient navigation, 2) knowledge of pregnancy and postpartum care, 3) health education and health promotion principles, 4) cultural sensitivity and health equity, 5) care coordination and community resources, and 6) electronic medical record systems. These core elements can serve as a basis for the development of adaptable curricula for a variety of institutions and contexts. We also offer recommendations for the implementation of a navigator training program. A curriculum such as this, with built-in flexibility to meet community and institutional needs, may promote the effective and sustainable use of patient navigation in the postpartum context.",2021,These core elements can serve as a basis for the development of adaptable curricula for a variety of institutions and contexts.,[],"['NNM2', 'patient navigation, 2) knowledge of pregnancy and postpartum care, 3) health education and health promotion principles, 4) cultural sensitivity and health equity, 5) care coordination and community resources, and 6) electronic medical record systems']",[],[],"[{'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C1319142', 'cui_str': 'Knowledge level: pregnancy'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C4042901', 'cui_str': 'Health Equity'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",[],,0.0225659,These core elements can serve as a basis for the development of adaptable curricula for a variety of institutions and contexts.,"[{'ForeName': 'Lynn M', 'Initials': 'LM', 'LastName': 'Yee', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Northwestern University Feinberg School of Medicine, Chicago, Illinois. Electronic address: Lynn.yee@northwestern.edu.'}, {'ForeName': 'Brittney', 'Initials': 'B', 'LastName': 'Williams', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Hannah M', 'Initials': 'HM', 'LastName': 'Green', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Viridiana', 'Initials': 'V', 'LastName': 'Carmona-Barrera', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Diaz', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': ""Ka'Derricka"", 'Initials': 'K', 'LastName': 'Davis', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Kominiarek', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Feinglass', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Department of Medicine, and Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Chloe A', 'Initials': 'CA', 'LastName': 'Zera', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Grobman', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2021.03.038'] 2920,33812692,"Ultrasound Core Laboratory for the Household Air Pollution Intervention Network Trial: Standardized Training and Image Management for Field Studies Using Portable Ultrasound in Fetal, Lung, and Vascular Evaluations.","Ultrasound Core Laboratories (UCL) are used in multicenter trials to assess imaging biomarkers to define robust phenotypes, to reduce imaging variability and to allow blinded independent review with the purpose of optimizing endpoint measurement precision. The Household Air Pollution Intervention Network, a multicountry randomized controlled trial (Guatemala, Peru, India and Rwanda), evaluates the effects of reducing household air pollution on health outcomes. Field studies using portable ultrasound evaluate fetal, lung and vascular imaging endpoints. The objective of this report is to describe administrative methods and training of a centralized clinical research UCL. A comprehensive administrative protocol and training curriculum included standard operating procedures, didactics, practical scanning and written/practical assessments of general ultrasound principles and specific imaging protocols. After initial online training, 18 sonographers (three or four per country and five from the UCL) participated in a 2 wk on-site training program. Written and practical testing evaluated ultrasound topic knowledge and scanning skills, and surveys evaluated the overall course. The UCL developed comprehensive standard operating procedures for image acquisition with a portable ultrasound system, digital image upload to cloud-based storage, off-line analysis and quality control. Pre- and post-training tests showed significant improvements (fetal ultrasound: 71% ± 13% vs. 93% ± 7%, p < 0.0001; vascular lung ultrasound: 60% ± 8% vs. 84% ± 10%, p < 0.0001). Qualitative and quantitative feedback showed high satisfaction with training (mean, 4.9 ± 0.1; scale: 1 = worst, 5 = best). The UCL oversees all stages: training, standardization, performance monitoring, image quality control and consistency of measurements. Sonographers who failed to meet minimum allowable performance were identified for retraining. In conclusion, a UCL was established to ensure accurate and reproducible ultrasound measurements in clinical research. Standardized operating procedures and training are aimed at reducing variability and enhancing measurement precision from study sites, representing a model for use of portable digital ultrasound for multicenter field studies.",2021,"Pre- and post-training tests showed significant improvements (fetal ultrasound: 71% ± 13% vs. 93% ± 7%, p < 0.0001; vascular lung ultrasound: 60% ± 8% vs. 84% ± 10%, p < 0.0001).",['Household Air Pollution Intervention Network Trial'],"['Ultrasound Core Laboratories (UCL', 'UCL']",[],"[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]",[],,0.0147548,"Pre- and post-training tests showed significant improvements (fetal ultrasound: 71% ± 13% vs. 93% ± 7%, p < 0.0001; vascular lung ultrasound: 60% ± 8% vs. 84% ± 10%, p < 0.0001).","[{'ForeName': 'Víctor G', 'Initials': 'VG', 'LastName': 'Dávila-Román', 'Affiliation': 'Cardiovascular Imaging and Clinical Research Core Laboratory, Cardiovascular Division, Department of Medicine, Washington University in St. Louis, Missouri, USA. Electronic address: vdavila@wustl.edu.'}, {'ForeName': 'Ashley K', 'Initials': 'AK', 'LastName': 'Toenjes', 'Affiliation': 'Cardiovascular Imaging and Clinical Research Core Laboratory, Cardiovascular Division, Department of Medicine, Washington University in St. Louis, Missouri, USA.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Meyers', 'Affiliation': 'Cardiovascular Imaging and Clinical Research Core Laboratory, Cardiovascular Division, Department of Medicine, Washington University in St. Louis, Missouri, USA.'}, {'ForeName': 'Pattie M', 'Initials': 'PM', 'LastName': 'Lenzen', 'Affiliation': 'Cardiovascular Imaging and Clinical Research Core Laboratory, Cardiovascular Division, Department of Medicine, Washington University in St. Louis, Missouri, USA.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Simkovich', 'Affiliation': 'Division of Pulmonary and Critical Care, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Phabiola', 'Initials': 'P', 'LastName': 'Herrera', 'Affiliation': 'Division of Pulmonary and Critical Care, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; Center for Global Non-Communicable Disease Research and Training, School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Fung', 'Affiliation': 'Division of Pulmonary and Critical Care, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; Center for Global Non-Communicable Disease Research and Training, School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Aris T', 'Initials': 'AT', 'LastName': 'Papageorghiou', 'Affiliation': ""Nuffield Department of Women's and Reproductive Health, University of Oxford, Oxford, UK.""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Craik', 'Affiliation': ""Nuffield Department of Women's and Reproductive Health, University of Oxford, Oxford, UK.""}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'McCracken', 'Affiliation': 'Centre for Health Studies, Universidad del Valle de Guatemala, Guatemala City, Guatemala.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Thompson', 'Affiliation': 'Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Kalpana', 'Initials': 'K', 'LastName': 'Balakrishnan', 'Affiliation': 'ICMR Center for Advanced Research on Air Quality, Climate and Health, Department of Environmental Health Engineering, Sri Ramachandra Institute of Higher Education and Research, Chennai, India.'}, {'ForeName': 'Ghislaine', 'Initials': 'G', 'LastName': 'Rosa', 'Affiliation': 'Department of Disease Control, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Peel', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, Colorado, USA.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Clasen', 'Affiliation': 'Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia; USA.'}, {'ForeName': 'Shakir', 'Initials': 'S', 'LastName': 'Hossen', 'Affiliation': 'Division of Pulmonary and Critical Care, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Checkley', 'Affiliation': 'Division of Pulmonary and Critical Care, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; Center for Global Non-Communicable Disease Research and Training, School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Lisa de Las', 'Initials': 'LL', 'LastName': 'Fuentes', 'Affiliation': 'Cardiovascular Imaging and Clinical Research Core Laboratory, Cardiovascular Division, Department of Medicine, Washington University in St. Louis, Missouri, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ultrasound in medicine & biology,['10.1016/j.ultrasmedbio.2021.02.015'] 2921,33812511,"Author Reply to ""Regarding 'Arthroscopic Bankart Repair With and Without Curettage of the Glenoid Edge: A Prospective, Randomized, Controlled Study'"".",,2021,,[],['Arthroscopic Bankart Repair With and Without Curettage of the Glenoid Edge'],[],[],"[{'cui': 'C0408087', 'cui_str': 'Arthroscopic reattachment glenoid labrum'}, {'cui': 'C0010468', 'cui_str': 'Curettage'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}]",[],,0.016993,,"[{'ForeName': 'Sanjay S', 'Initials': 'SS', 'LastName': 'Desai', 'Affiliation': 'Bhatia Hospital, Mumbai; Shoulder and Knee Clinic, Maharashtra.'}, {'ForeName': 'Vishwajeet', 'Initials': 'V', 'LastName': 'Singh', 'Affiliation': ''}, {'ForeName': 'Hari Krishna', 'Initials': 'HK', 'LastName': 'Mata', 'Affiliation': 'Shoulder and Knee Clinic, Maharashtra, India.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2021.01.029'] 2922,33812510,"Regarding ""Arthroscopic Bankart Repair With and Without Curettage of the Glenoid Edge: A Prospective, Randomized, Controlled Study"".",,2021,,[],[],[],[],[],[],,0.0140351,,"[{'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Gazendam', 'Affiliation': 'Division of Orthopedics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Moin', 'Initials': 'M', 'LastName': 'Khan', 'Affiliation': 'Division of Orthopedics, McMaster University, Hamilton, Ontario, Canada.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2021.01.030'] 2923,33810379,"Digital Smile Designed Computer-Aided Surgery versus Traditional Workflow in ""All on Four"" Rehabilitations: A Randomized Clinical Trial with 4-Years Follow-Up.","The aim of the present study was to evaluate and compare the traditional ""All on Four"" technique with digital smile designed computer-aided ""All on Four"" rehabilitation; with a 4-years follow-up. The protocol was applied to a total of 50 patients randomly recruited and divided in two groups. Digital protocol allows for a completely virtual planning of the exact position of the fixtures, which allows one to perform a flapless surgery procedure with great accuracy (mini-invasive surgery) and also it is possible to use virtually planned prostheses realized with Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) (methods for an immediate loading of the implants. After 4 years from the treatments 98% of success were obtained for the group of patients treated with the traditional protocol and 100% for the digital protocol. At each time interval a significant difference in peri-implant crestal bone loss between the two groups was detected; with an average Marginal Bone Loss (MBL) at 4 years of 1.12 ± 0.26 mm in the traditional group and 0.83 ± 0.11 mm in the digital group. Patients belonging to the digital group have judged the immediate loading (92%), digital smile preview (93%), the mock-up test (98%) and guided surgery (94%) as very effective. All patients treated with a digital method reported lower values of during-surgery and post-surgery pain compared to patients rehabilitated using traditional treatment. In conclusion, the totally digital protocol described in the present study represents a valid therapeutic alternative to the traditional ""All on Four"" protocol for implant-supported rehabilitations of edentulous dental arches.",2021,At each time interval a significant difference in peri-implant crestal bone loss between the two groups was detected; with an average Marginal Bone Loss (MBL) at 4 years of 1.12 ± 0.26 mm in the traditional group and 0.83 ± 0.11 mm in the digital group.,['50 patients randomly recruited and divided in two groups'],"['Digital Smile Designed Computer-Aided Surgery versus Traditional Workflow', 'traditional ""All on Four"" technique with digital smile designed computer-aided ""All on Four"" rehabilitation']","['average Marginal Bone Loss (MBL', 'lower values of during-surgery and post-surgery pain', 'immediate loading', 'peri-implant crestal bone loss', 'digital smile preview']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0037363', 'cui_str': 'Smiling'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0949696', 'cui_str': 'Computer-Assisted Surgery'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C1710679', 'cui_str': 'Work Flow'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0065661', 'cui_str': 'Mannose-binding protein'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0037363', 'cui_str': 'Smiling'}]",50.0,0.0343512,At each time interval a significant difference in peri-implant crestal bone loss between the two groups was detected; with an average Marginal Bone Loss (MBL) at 4 years of 1.12 ± 0.26 mm in the traditional group and 0.83 ± 0.11 mm in the digital group.,"[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Cattoni', 'Affiliation': 'Department of Dentistry, IRCCS San Raffaele Hospital, 20132 Milan, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Chirico', 'Affiliation': 'Department of Dentistry, IRCCS San Raffaele Hospital, 20132 Milan, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Merlone', 'Affiliation': 'Department of Dentistry, IRCCS San Raffaele Hospital, 20132 Milan, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Manacorda', 'Affiliation': 'Department of Dentistry, IRCCS San Raffaele Hospital, 20132 Milan, Italy.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Vinci', 'Affiliation': 'Department of Dentistry, IRCCS San Raffaele Hospital, 20132 Milan, Italy.'}, {'ForeName': 'Enrico Felice', 'Initials': 'EF', 'LastName': 'Gherlone', 'Affiliation': 'Department of Dentistry, IRCCS San Raffaele Hospital, 20132 Milan, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph18073449'] 2924,33810154,Current FDA-Approved Therapies for High-Grade Malignant Gliomas.,"The standard of care (SOC) for high-grade gliomas (HGG) is maximally safe surgical resection, followed by concurrent radiation therapy (RT) and temozolomide (TMZ) for 6 weeks, then adjuvant TMZ for 6 months. Before this SOC was established, glioblastoma (GBM) patients typically lived for less than one year after diagnosis, and no adjuvant chemotherapy had demonstrated significant survival benefits compared with radiation alone. In 2005, the Stupp et al. randomized controlled trial (RCT) on newly diagnosed GBM patients concluded that RT plus TMZ compared to RT alone significantly improved overall survival (OS) (14.6 vs. 12.1 months) and progression-free survival (PFS) at 6 months (PFS6) (53.9% vs. 36.4%). Outside of TMZ, there are four drugs and one device FDA-approved for the treatment of HGGs: lomustine, intravenous carmustine, carmustine wafer implants, bevacizumab (BVZ), and tumor treatment fields (TTFields). These treatments are now mainly used to treat recurrent HGGs and symptoms. TTFields is the only treatment that has been shown to improve OS (20.5 vs. 15.6 months) and PFS6 (56% vs. 37%) in comparison to the current SOC. TTFields is the newest addition to this list of FDA-approved treatments, but has not been universally accepted yet as part of SOC.",2021,TTFields is the only treatment that has been shown to improve OS (20.5 vs. 15.6 months) and PFS6 (56% vs. 37%) in comparison to the current SOC.,[],"['concurrent radiation therapy (RT) and temozolomide (TMZ', 'RT plus TMZ', 'HGGs: lomustine, intravenous carmustine, carmustine wafer implants, bevacizumab (BVZ', 'TMZ']","['PFS6', 'survival benefits', 'OS', 'progression-free survival (PFS', 'overall survival (OS']",[],"[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023972', 'cui_str': 'Lomustine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0007257', 'cui_str': 'Carmustine'}, {'cui': 'C0991560', 'cui_str': 'Oral Wafer'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.118915,TTFields is the only treatment that has been shown to improve OS (20.5 vs. 15.6 months) and PFS6 (56% vs. 37%) in comparison to the current SOC.,"[{'ForeName': 'Jacob P', 'Initials': 'JP', 'LastName': 'Fisher', 'Affiliation': 'Division of Biochemistry, Southern Virginia University, Buena Vista, VA 24416, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Adamson', 'Affiliation': 'Department of Neurosurgery, School of Medicine, Emory University, Atlanta, GA 30322, USA.'}]",Biomedicines,['10.3390/biomedicines9030324'] 2925,33810061,Effects of School-Based Exercise Program on Obesity and Physical Fitness of Urban Youth: A Quasi-Experiment.,"(1) Purpose: The purpose of this study was to evaluate if an after-school intervention program could prevent obesity and promote the physical fitness of urban sedentary school children. (2) Methods: A 16-week after-school physical fitness program was provided to 36 middle school students (7th, 8th, and 9th graders) recruited from a middle school for three days a week. They were high-risk youth showing poor health status (level 4 or 5) in the regular physical fitness evaluation conducted. Their body mass index (BMI), cardiovascular endurance, muscular strength and endurance, quickness, and flexibility were evaluated. (3) Results: A paired sample t -test was used (α = 0.05). There were statistical differences ((x ± s), p < 0.05) between the pre-Progressive Aerobic Cardiovascular Endurance Run (PACER) (13.36 ± 4.98 (# of laps)) and post-PACER (18.64 ± 6.31 (# of laps)) ( p < 0.001), between the pre-sit-up (18.06 ± 7.22 (# of sit-ups)) and post-sit-up (24.89 ± 7.52 (# of sit-ups)) ( p < 0.001), and between the pre-Trunk Flexion (2.64 ± 3.49 ((cm))) and post-Trunk Flexion (5.97 ± 2.78 ((cm)) ( p < 0.001). There was no statistical difference between the pre-50m-Run (10.74 ± 1.30 ((sec))) and post-50m-Run results (10.69 ± 1.25 (sec)) ( p = 0.063) or between the pre-BMI (24.84 ± 3.97 (kg/m 2 )) and post-BMI (24.76 ± 3.61 (kg/m 2 )) ( p = 0.458). Overall, the physical fitness measures improved, whereas BMI did not change after 16 weeks. (4) Conclusion: Sixteen weeks of the school-based Health-related Physical Fitness (HrPF) program can be effective in improving overall physical fitness levels of adolescents, although additional treatments would be required to change BMI, which showed no improvement in the present study. It is concluded that in order for adolescents to maintain and promote physical fitness and health, participation in a school-based HrPF program is recommended for at least 30 min a day, three days a week. In addition, schools should provide high-risk youth with easy access to physical activities that are similar to the objectives of the physical education curriculum. In order to promote the health of school-age children, each school should establish and operate school-based systematic intervention programs.",2021,"There were statistical differences ((x ± s), p < 0.05) between the pre-Progressive Aerobic Cardiovascular Endurance Run (PACER) (13.36 ± 4.98 (# of laps)) and post-PACER (18.64 ± 6.31 (# of laps)) ( p < 0.001), between the pre-sit-up (18.06 ± 7.22 (# of sit-ups)) and post-sit-up (24.89 ± 7.52 (# of sit-ups)) ( p < 0.001), and between the pre-Trunk Flexion (2.64 ± 3.49 ((cm))) and post-Trunk Flexion (5.97 ± 2.78 ((cm)) ( p < 0.001).","['urban sedentary school children', 'Urban Youth', 'They were high-risk youth showing poor health status (level 4 or 5) in the regular physical fitness evaluation conducted', '36 middle school students (7th, 8th, and 9th graders) recruited from a middle school for three days a week']","['school-based Health-related Physical Fitness (HrPF) program', 'School-Based Exercise Program', 'school physical fitness program', 'school intervention program']","['pre-Progressive Aerobic Cardiovascular Endurance Run (PACER', 'body mass index (BMI), cardiovascular endurance, muscular strength and endurance, quickness, and flexibility', 'BMI', 'Obesity and Physical Fitness', 'physical fitness measures']","[{'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0456950', 'cui_str': 'Level 4'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",36.0,0.022092,"There were statistical differences ((x ± s), p < 0.05) between the pre-Progressive Aerobic Cardiovascular Endurance Run (PACER) (13.36 ± 4.98 (# of laps)) and post-PACER (18.64 ± 6.31 (# of laps)) ( p < 0.001), between the pre-sit-up (18.06 ± 7.22 (# of sit-ups)) and post-sit-up (24.89 ± 7.52 (# of sit-ups)) ( p < 0.001), and between the pre-Trunk Flexion (2.64 ± 3.49 ((cm))) and post-Trunk Flexion (5.97 ± 2.78 ((cm)) ( p < 0.001).","[{'ForeName': 'Ji Hwan', 'Initials': 'JH', 'LastName': 'Song', 'Affiliation': 'Department of Physical Education, Jeonju National University of Education, Jeonju-si 55101, Korea.'}, {'ForeName': 'Ho Hyun', 'Initials': 'HH', 'LastName': 'Song', 'Affiliation': 'Ho-Sung Middle School, Jeollabukdo Office of Education, Jeonju-si 54817, Korea.'}, {'ForeName': 'Sukwon', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Education, Jeonbuk National University, Jeonju-si 54896, Korea.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare9030358'] 2926,33809796,The Effects of a Low Sodium Meal Plan on Blood Pressure in Older Adults: The SOTRUE Randomized Feasibility Trial.,"Reduced sodium meal plans are recommended by the Centers of Disease Control to lower blood pressure in older adults; however, this strategy has not been tested in a clinical trial. The Satter House Trial of Reduced Sodium Meals (SOTRUE) was an individual-level, double-blind, randomized controlled pilot study of adults living in a congregate living facility subsidized by the Federal Department of Housing and Urban Development (HUD). Adults over age 60 years ate 3 isocaloric meals with two snacks daily for 14 days. The meal plans differed in sodium density (<0.95 vs. >2 mg/kcal), but were equivalent in potassium and macronutrients. Seated systolic BP (SBP) was the primary outcome, while urine sodium-creatinine ratio was used to measure compliance. Twenty participants were randomized (95% women; 95% white; mean age 78 ± 8 years), beginning in 7 October 2019. Retention was 100% with the last participant ending 4 November 2019. Mean baseline SBP changed from 121 to 116 mmHg with the typical sodium diet (-5 mmHg; 95% CI: -18, 8) and from 123 to 112 mmHg with the low sodium diet (-11 mmHg; 95% CI: -15.2, -7.7). Compared to the typical sodium meal plan, the low sodium meal plan lowered SBP by 4.8 mmHg (95% CI: -14.4, 4.9; p = 0.31) and urine sodium-creatinine ratio by 36% (-36.0; 95% CI: -60.3, 3.4; p = 0.07), both non-significant. SOTRUE demonstrates the feasibility of sodium reduction in federally mandated meal plans. A longer and larger study is needed to establish the efficacy and safety of low sodium meals in older adults.",2021,"Compared to the typical sodium meal plan, the low sodium meal plan lowered SBP by 4.8 mmHg (95% CI: -14.4, 4.9; p = 0.31) and urine sodium-creatinine ratio by 36% (-36.0; 95% CI: -60.3, 3.4; p = 0.07), both non-significant.","['adults living in a congregate living facility subsidized by the Federal Department of Housing and Urban Development (HUD', 'older adults', 'Older Adults', 'Adults over age 60 years ate 3', 'Twenty participants were randomized (95% women; 95% white; mean age 78 ± 8 years), beginning in 7 October 2019']","['low sodium meals', 'Low Sodium Meal Plan', 'isocaloric meals']","['Seated systolic BP (SBP', 'Blood Pressure', 'sodium density', 'urine sodium-creatinine ratio', 'Mean baseline SBP']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0041932', 'cui_str': 'Urban Development'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C0012169', 'cui_str': 'Low sodium diet'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0596014', 'cui_str': 'Does plan meals'}]","[{'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1256585', 'cui_str': 'Sodium measurement, urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",20.0,0.202545,"Compared to the typical sodium meal plan, the low sodium meal plan lowered SBP by 4.8 mmHg (95% CI: -14.4, 4.9; p = 0.31) and urine sodium-creatinine ratio by 36% (-36.0; 95% CI: -60.3, 3.4; p = 0.07), both non-significant.","[{'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA 02215, USA.'}, {'ForeName': 'Courtney L', 'Initials': 'CL', 'LastName': 'Millar', 'Affiliation': 'Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA 02215, USA.'}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Foley', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, Roslindale, MA 02131, USA.'}, {'ForeName': 'Misha', 'Initials': 'M', 'LastName': 'Shtivelman', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, Roslindale, MA 02131, USA.'}, {'ForeName': 'Alegria', 'Initials': 'A', 'LastName': 'Cohen', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, Roslindale, MA 02131, USA.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'McNally', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, Roslindale, MA 02131, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Crevatis', 'Affiliation': 'The Jack Satter House, Revere, MA 02151, USA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Post', 'Affiliation': 'The Jack Satter House, Revere, MA 02151, USA.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Mukamal', 'Affiliation': 'Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA 02215, USA.'}, {'ForeName': 'Lewis A', 'Initials': 'LA', 'LastName': 'Lipsitz', 'Affiliation': 'Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA 02215, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Cluett', 'Affiliation': 'Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA 02215, USA.'}, {'ForeName': 'Roger B', 'Initials': 'RB', 'LastName': 'Davis', 'Affiliation': 'Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA 02215, USA.'}, {'ForeName': 'Shivani', 'Initials': 'S', 'LastName': 'Sahni', 'Affiliation': 'Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA 02215, USA.'}]",Nutrients,['10.3390/nu13030964'] 2927,33809354,"Effect of Gazpacho, Hummus and Ajoblanco on Satiety and Appetite in Adult Humans: A Randomised Crossover Study.","Nowadays, overweight and obesity has reached an epidemic level around the world. With the aim to tackle them, an interesting strategy is the study of food and ingredients with satiety properties. In addition to reducing food and/or calorie intake, this type of foods must be included as part of a healthy diet. With regard to this, it is well known that the Mediterranean Diet (MD) is a feeding pattern that helps us to maintain good health, providing an adequate intake of micronutrients and active compounds. With this background, the main aim of this research was to identify MD foods with a high satiating potential capacity. For this purpose, three typical foods of the Mediterranean region, mainly based on vegetables, were selected: hummus, ajoblanco and gazpacho. As a control, white bread was used. Twenty-four human healthy volunteers consumed a standard breakfast followed by the different typical Mediterranean foods, and then the subjective sensation of hunger and satiety for each food was assessed by visual analogue scales (VAS) during 3 h. Subsequently, volunteers had ad libitum access to a standard meal. The results indicate that gazpacho showed the highest satiating scores, despite the fact that it was not the food that provided the highest protein or fibre amount. More studies of this type are needed to determine the proportion and/or combination of ingredients from these classical Mediterranean recipes that could enhance human satiety.",2021,"The results indicate that gazpacho showed the highest satiating scores, despite the fact that it was not the food that provided the highest protein or fibre amount.","['Twenty-four human healthy volunteers', 'Adult Humans']","['Gazpacho, Hummus and Ajoblanco', 'gazpacho']","['Satiety and Appetite', 'visual analogue scales (VAS']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0453218', 'cui_str': 'Hummus'}]","[{'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",24.0,0.0246378,"The results indicate that gazpacho showed the highest satiating scores, despite the fact that it was not the food that provided the highest protein or fibre amount.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Planes-Muñoz', 'Affiliation': 'Food Science and Human Nutrition Department, Faculty of Veterinary, Regional Campus of International Excellence ""Campus Mare Nostrum"", Campus de Espinardo, University of Murcia, 30100 Murcia, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Frontela-Saseta', 'Affiliation': 'Food Science and Human Nutrition Department, Faculty of Veterinary, Regional Campus of International Excellence ""Campus Mare Nostrum"", Campus de Espinardo, University of Murcia, 30100 Murcia, Spain.'}, {'ForeName': 'Gaspar', 'Initials': 'G', 'LastName': 'Ros-Berruezo', 'Affiliation': 'Food Science and Human Nutrition Department, Faculty of Veterinary, Regional Campus of International Excellence ""Campus Mare Nostrum"", Campus de Espinardo, University of Murcia, 30100 Murcia, Spain.'}, {'ForeName': 'Rubén', 'Initials': 'R', 'LastName': 'López-Nicolás', 'Affiliation': 'Food Science and Human Nutrition Department, Faculty of Veterinary, Regional Campus of International Excellence ""Campus Mare Nostrum"", Campus de Espinardo, University of Murcia, 30100 Murcia, Spain.'}]","Foods (Basel, Switzerland)",['10.3390/foods10030606'] 2928,33809346,"Preventive Analgesia, Hemodynamic Stability, and Pain in Vitreoretinal Surgery.","Background and Objectives: Although vitreoretinal surgery (VRS) is most commonly performed under regional anaesthesia (RA), in patients who might be unable to cooperate during prolonged procedures, general anaesthesia (GA) with intraprocedural use of opioid analgesics (OA) might be worth considering. It seems that the surgical pleth index (SPI) can be used to optimise the intraprocedural titration of OA, which improves haemodynamic stability. Preventive analgesia (PA) is combined with GA to minimise intraprocedural OA administration. Materials and Methods: We evaluated the benefit of PA combined with GA using SPI-guided fentanyl (FNT) administration on the incidences of PIPP (postprocedural intolerable pain perception) and haemodynamic instability in patients undergoing VRS ( p < 0.05). We randomly assigned 176 patients undergoing VRS to receive GA with SPI-guided FNT administration alone (GA group) or with preventive topical 2% proparacaine (topical anaesthesia (TA) group), a preprocedural peribulbar block (PBB) using 0.5% bupivacaine with 2% lidocaine (PBB group), or a preprocedural intravenous infusion of 1.0 g of metamizole (M group) or 1.0 g of paracetamol (P group). Results: Preventive PBB reduced the intraprocedural FNT requirement without influencing periprocedural outcomes ( p < 0.05). Intraprocedural SPI-guided FNT administration during GA resulted in PIPP in 13.5% of patients undergoing VRS and blunted the periprocedural effects of preventive intravenous and regional analgesia with respect to PIPP and haemodynamic instability. Conclusions: SPI-guided FNT administration during GA eliminated the benefits of preventive analgesia in the PBB, TA, M, and P groups following VRS.",2021,Preventive PBB reduced the intraprocedural FNT requirement without influencing periprocedural outcomes ( p < 0.05).,"['176 patients undergoing', 'patients who might be unable to cooperate during prolonged procedures, general anaesthesia (GA) with intraprocedural use of opioid analgesics (OA', 'patients undergoing VRS ( p < 0.05', 'Vitreoretinal Surgery']","['Preventive analgesia (PA', 'PA combined with GA using SPI-guided fentanyl (FNT', 'preprocedural peribulbar block (PBB) using 0.5% bupivacaine with 2% lidocaine (PBB group), or a preprocedural intravenous infusion of 1.0 g of metamizole (M group) or 1.0 g of paracetamol', 'VRS to receive GA with SPI-guided FNT administration alone (GA group) or with preventive topical 2% proparacaine (topical anaesthesia (TA', 'vitreoretinal surgery (VRS']","['haemodynamic stability', 'Preventive Analgesia, Hemodynamic Stability, and Pain', 'incidences of PIPP (postprocedural intolerable pain perception) and haemodynamic instability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0566415', 'cui_str': 'Unable to feed self'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0458261', 'cui_str': 'Verbal rating scale'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C2936205', 'cui_str': 'Vitreoretinal Surgery'}]","[{'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0583006', 'cui_str': 'Peribulbar infiltration of local anesthetic'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0032441', 'cui_str': 'Polybrominated biphenyl'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0012586', 'cui_str': 'Dipyrone'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0458261', 'cui_str': 'Verbal rating scale'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0072510', 'cui_str': 'proparacaine'}, {'cui': 'C0472473', 'cui_str': 'Topical local anesthetic'}, {'cui': 'C2936205', 'cui_str': 'Vitreoretinal Surgery'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0070798', 'cui_str': 'PtdIns(4,5)P2'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0948268', 'cui_str': 'Hemodynamic instability'}]",176.0,0.138987,Preventive PBB reduced the intraprocedural FNT requirement without influencing periprocedural outcomes ( p < 0.05).,"[{'ForeName': 'Michał Jan', 'Initials': 'MJ', 'LastName': 'Stasiowski', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medical Sciences, Medical University of Silesia, 41-200 Sosnowiec, Poland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Pluta', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medical Sciences, Medical University of Silesia, 41-200 Sosnowiec, Poland.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Lyssek-Boroń', 'Affiliation': 'Department of Ophthalmology with Paediatric Unit, 5th Regional Hospital, Medykow Square 1, 41-200 Sosnowiec, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Kawka', 'Affiliation': 'Department of Ophthalmology with Paediatric Unit, 5th Regional Hospital, Medykow Square 1, 41-200 Sosnowiec, Poland.'}, {'ForeName': 'Lech', 'Initials': 'L', 'LastName': 'Krawczyk', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medical Sciences, Medical University of Silesia, 41-200 Sosnowiec, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Niewiadomska', 'Affiliation': 'Department of Epidemiology and Biostatistics, Faculty of Health Sciences, Medical University of Silesia, 41-902 Bytom, Poland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Dobrowolski', 'Affiliation': 'Chair and Clinical Department of Ophthalmology, Faculty of Medical Sciences, Medical University of Silesia, 41-200 Zabrze, Poland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Rejdak', 'Affiliation': 'Department of General Ophthalmology, Medical University of Lublin, 20-059 Lublin, Poland.'}, {'ForeName': 'Seweryn', 'Initials': 'S', 'LastName': 'Król', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, 5th Regional Hospital, Medykow Square 1, 41-200 Sosnowiec, Poland.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Żak', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medical Sciences, Medical University of Silesia, 41-200 Sosnowiec, Poland.'}, {'ForeName': 'Izabela', 'Initials': 'I', 'LastName': 'Szumera', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medical Sciences, Medical University of Silesia, 41-200 Sosnowiec, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Missir', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medical Sciences, Medical University of Silesia, 41-200 Sosnowiec, Poland.'}, {'ForeName': 'Przemysław', 'Initials': 'P', 'LastName': 'Jałowiecki', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medical Sciences, Medical University of Silesia, 41-200 Sosnowiec, Poland.'}, {'ForeName': 'Beniamin Oskar', 'Initials': 'BO', 'LastName': 'Grabarek', 'Affiliation': 'Department of Histology, Cytophysiology and Embryology, Faculty of Medicine, University of Technology in Katowice, 41-800 Zabrze, Poland.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina57030262'] 2929,33809281,Towards Extending the Detection Window of Gamma-Hydroxybutyric Acid-An Untargeted Metabolomics Study in Serum and Urine Following Controlled Administration in Healthy Men.,"In forensic toxicology, gamma-hydroxybutyrate (GHB) still represents one of the most challenging drugs of abuse in terms of analytical detection and interpretation. Given its rapid elimination, the detection window of GHB in common matrices is short (maximum 12 h in urine). Additionally, the differentiation from naturally occurring endogenous GHB, is challenging. Thus, novel biomarkers to extend the detection window of GHB are urgently needed. The present study aimed at searching new potential biomarkers of GHB use by means of mass spectrometry (MS) metabolomic profiling in serum (up to 16.5 h) and urine samples (up to 8 h after intake) collected during a placebo-controlled crossover study in healthy men. MS data acquired by different analytical methods (reversed phase and hydrophilic interaction liquid chromatography; positive and negative electrospray ionization each) were filtered for significantly changed features applying univariate and mixed-effect model statistics. Complementary to a former study, conjugates of GHB with glycine, glutamate, taurine, carnitine and pentose (ribose) were identified in urine, with particularly GHB-pentose being promising for longer detection. None of the conjugates were detectable in serum. Therein, mainly energy metabolic substrates were identified, which may be useful for more detailed interpretation of underlying pathways but are too unspecific as biomarkers.",2021,None of the conjugates were detectable in serum.,"['Healthy Men', 'healthy men']","['placebo', 'glycine, glutamate, taurine, carnitine and pentose (ribose', 'gamma-hydroxybutyrate (GHB']",[],"[{'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0039350', 'cui_str': 'Taurine'}, {'cui': 'C0007258', 'cui_str': 'Carnitine'}, {'cui': 'C0030894', 'cui_str': 'Pentose'}, {'cui': 'C0035549', 'cui_str': 'Ribose'}, {'cui': 'C0000503', 'cui_str': '4-hydroxybutyrate'}]",[],,0.0599597,None of the conjugates were detectable in serum.,"[{'ForeName': 'Andrea E', 'Initials': 'AE', 'LastName': 'Steuer', 'Affiliation': 'Department of Forensic Pharmacology & Toxicology, Zurich Institute of Forensic Medicine, University of Zurich, 8057 Zurich, Switzerland.'}, {'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Raeber', 'Affiliation': 'Department of Forensic Pharmacology & Toxicology, Zurich Institute of Forensic Medicine, University of Zurich, 8057 Zurich, Switzerland.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Simbuerger', 'Affiliation': 'Department of Forensic Pharmacology & Toxicology, Zurich Institute of Forensic Medicine, University of Zurich, 8057 Zurich, Switzerland.'}, {'ForeName': 'Dario A', 'Initials': 'DA', 'LastName': 'Dornbierer', 'Affiliation': 'Department of Forensic Pharmacology & Toxicology, Zurich Institute of Forensic Medicine, University of Zurich, 8057 Zurich, Switzerland.'}, {'ForeName': 'Oliver G', 'Initials': 'OG', 'LastName': 'Bosch', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, 8032 Zurich, Switzerland.'}, {'ForeName': 'Boris B', 'Initials': 'BB', 'LastName': 'Quednow', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, 8032 Zurich, Switzerland.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Seifritz', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, 8032 Zurich, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kraemer', 'Affiliation': 'Department of Forensic Pharmacology & Toxicology, Zurich Institute of Forensic Medicine, University of Zurich, 8057 Zurich, Switzerland.'}]",Metabolites,['10.3390/metabo11030166'] 2930,33809277,Telerehabilitation Intervention in Patients with COVID-19 after Hospital Discharge to Improve Functional Capacity and Quality of Life. Study Protocol for a Multicenter Randomized Clinical Trial.,"COVID-19 can cause important sequels in the respiratory system and frequently presents loss of strength, dyspnea, polyneuropathies and multi-organic affectation. Physiotherapy interventions acquire a fundamental role in the recovery of the functions and the quality of life. Regarding the recovery phases after hospital discharge, the current evidence available is very preliminary. Telerehabilitation is presented as a promising complementary treatment method to standard physiotherapy. The main objective of this research is to evaluate the effectiveness of a personalized telerehabilitation intervention after discharge from hospital for the improvement of functional capacity and quality of life compared to a program of health education and/or care in a rehabilitation center. As secondary objectives, to identify the satisfaction and perception of patients with the telerehabilitation intervention and the presence of barriers to its implementation, as well as to evaluate the cost-effectiveness from the perspective of the health system. This study protocol will be carried out through a single blind multicenter randomized clinical trial in the south of Spain. We hypothesize that the implementation of a telerehabilitation program presents results not inferior to those obtained with the current standard intervention. If the hypothesis is confirmed, it would be an opportunity to define new policies and interventions to address this disease and its consequences. Trial registration NCT04742946.",2021,The main objective of this research is to evaluate the effectiveness of a personalized telerehabilitation intervention after discharge from hospital for the improvement of functional capacity and quality of life compared to a program of health education and/or care in a rehabilitation center.,"['Patients with COVID-19 after Hospital Discharge', 'south of Spain']","['Telerehabilitation Intervention', 'Physiotherapy interventions', 'personalized telerehabilitation intervention']","['functional capacity and quality of life', 'Functional Capacity and Quality of Life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}]","[{'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0652101,The main objective of this research is to evaluate the effectiveness of a personalized telerehabilitation intervention after discharge from hospital for the improvement of functional capacity and quality of life compared to a program of health education and/or care in a rehabilitation center.,"[{'ForeName': 'José-Manuel', 'Initials': 'JM', 'LastName': 'Pastora-Bernal', 'Affiliation': 'Department of Physiotherapy, Faculty of Health Science, University of Granada, 18071 Granada, Spain.'}, {'ForeName': 'María-José', 'Initials': 'MJ', 'LastName': 'Estebanez-Pérez', 'Affiliation': 'Department of Physiotherapy, Faculty of Health Science, University of Malaga, 29071 Málaga, Spain.'}, {'ForeName': 'Guadalupe', 'Initials': 'G', 'LastName': 'Molina-Torres', 'Affiliation': 'Department of Nursing Science, Physiotherapy and Medicine, University of Almeria, 04120 Almeria, Spain.'}, {'ForeName': 'Francisco-José', 'Initials': 'FJ', 'LastName': 'García-López', 'Affiliation': 'Department of Physiotherapy, University of Osuna, 41640 Seville, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Sobrino-Sánchez', 'Affiliation': 'Department of Physiotherapy, University of Osuna, 41640 Seville, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Martín-Valero', 'Affiliation': 'Department of Physiotherapy, Faculty of Health Science, University of Malaga, 29071 Málaga, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph18062924'] 2931,33808205,Effects of Different Dialysis Strategies on Inflammatory Cytokine Profile in Maintenance Hemodialysis Patients with COVID-19: A Randomized Trial.,"Uncontrolled inflammation plays a relevant role in the pathogenesis of coronavirus disease-19 (COVID-19). Here, we studied the time trend of inflammatory markers in a population of hemodialysis (HD) patients affected by COVID-19, undergoing two different dialysis approaches. In a prospective study, thirty-one maintenance HD patients with COVID-19 were randomized to expanded HD (HDx), performed using a medium cut-off membrane, or standard treatment using a protein-leaking dialyzer (PLD). Circulating levels of interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-10 (IL-10), soluble TLR4 (sTLR4), and interferon-gamma (IFN-γ), were collected at diagnosis, and one and two weeks after. Compared with 14 non-infected HD patients, COVID-19 patients showed lymphopenia and higher ferritin and lactate dehydrogenase levels. Moreover, COVID-19 patients had higher levels of IL-10 (15.2 (12.5) vs. 1.2 (1.4) pg/mL, p = 0.02). Twenty-nine patients were randomized to HDx (n = 15) or PLD (n = 14). After a single treatment, IL-8 showed a significant reduction in both groups, whereas IL-10 decreased only in HDx. All over the study, there were no significant modifications in circulating cytokine levels between the two groups, except for a parallel increase of IL-8 and IL-10 at one week control in the HDx group. No correlations were found between cytokine levels and clinical outcomes. In maintenance HD patients, COVID-19 is not related to a sustained inflammatory response. Therefore, modulation of inflammation seems not to be a suitable therapeutic target in this specific population.",2021,"Circulating levels of interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-10 (IL-10), soluble TLR4 (sTLR4), and interferon-gamma (IFN-γ), were collected at diagnosis, and one and two weeks after.","['Twenty-nine patients were randomized to HDx (n = 15) or PLD (n = 14', 'Maintenance Hemodialysis Patients with COVID-19', 'thirty-one maintenance HD patients with COVID-19', 'population of hemodialysis (HD) patients affected by COVID-19, undergoing two different dialysis approaches']","['expanded HD (HDx), performed using a medium cut-off membrane, or standard treatment using a protein-leaking dialyzer (PLD', 'Dialysis Strategies']","['cytokine levels and clinical outcomes', 'lymphopenia and higher ferritin and lactate dehydrogenase levels', 'IL-8 and IL-10', 'IL-10', 'circulating cytokine levels', 'Inflammatory Cytokine Profile', 'levels of IL-10', 'Circulating levels of interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-10 (IL-10), soluble TLR4 (sTLR4), and interferon-gamma (IFN-γ']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038164', 'cui_str': 'Protein A'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}]","[{'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0743912', 'cui_str': 'Ferritin increased'}, {'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C1321919', 'cui_str': 'TLR4 protein, human'}, {'cui': 'C0021745', 'cui_str': 'Interferon Type II'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}]",31.0,0.0715908,"Circulating levels of interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-10 (IL-10), soluble TLR4 (sTLR4), and interferon-gamma (IFN-γ), were collected at diagnosis, and one and two weeks after.","[{'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Esposito', 'Affiliation': 'Department of Internal Medicine, University of Genova, 16132 Genova, Italy.'}, {'ForeName': 'Leda', 'Initials': 'L', 'LastName': 'Cipriani', 'Affiliation': 'Department of Internal Medicine, University of Genova, 16132 Genova, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Verzola', 'Affiliation': 'Department of Internal Medicine, University of Genova, 16132 Genova, Italy.'}, {'ForeName': 'Maria Antonietta', 'Initials': 'MA', 'LastName': 'Grignano', 'Affiliation': 'Unit of Nephrology, Dialysis and Transplantation, Fondazione IRCCS Policlinico San Matteo, and University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'De Amici', 'Affiliation': 'Laboratory of Immuno-Allergology of Clinical Chemistry and Pediatric Clinic, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy.'}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Testa', 'Affiliation': 'Pediatrics Clinic, Fondazione IRCCS Policlinico San Matteo, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Grosjean', 'Affiliation': 'Unit of Nephrology, Dialysis and Transplantation, Fondazione IRCCS Policlinico San Matteo, and University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Russo', 'Affiliation': 'Department of Internal Medicine, University of Genova, 16132 Genova, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Garibotto', 'Affiliation': 'Department of Internal Medicine, University of Genova, 16132 Genova, Italy.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Rampino', 'Affiliation': 'Unit of Nephrology, Dialysis and Transplantation, Fondazione IRCCS Policlinico San Matteo, and University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Viazzi', 'Affiliation': 'Department of Internal Medicine, University of Genova, 16132 Genova, Italy.'}]",Journal of clinical medicine,['10.3390/jcm10071383'] 2932,33808137,"The Effects of Taping Combined with Wrist Stabilization Exercise on Pain, Disability, and Quality of Life in Postpartum Women with Wrist Pain: A Randomized Controlled Pilot Study.","The purpose of this study was to evaluate the effects of wrist stabilization exercise combined with taping on wrist pain, disability, and quality of life in postpartum women with wrist pain. Forty-five patients with wrist pain were recruited and randomly divided into three groups: wrist stabilization exercise + taping therapy (WSE + TT) group (n = 15), wrist stabilization exercise (WSE) group (n = 15), and control group (n = 15). The WSE + TT and WSE groups performed wrist stabilization exercises for 40 min (once a day, five times a week for eight weeks), and the control group performed passive range of motion (P-ROM) exercise for the same amount of time. Additionally, the WSE + TT group attached taping to the wrist and forearm during the training period. The visual analogue scale (VAS) was used to assess pain level of the wrist. The Disabilities of the Arm, Shoulder and Hand (DASH) and the Short Form-36 (SF-36) were used to evaluate the degree of wrist disability and quality of life, respectively. The WSE + TT group showed a significant decrease in wrist pain and functional disability compared to two groups ( p < 0.05). Significant improvement in the SF-36 score was observed in the WSE + TT and WSE groups compared to that in the control group ( p < 0.05). However, there was no significant difference between the WSE + TT and WSE groups in the SF-36. Our findings indicate that wrist stabilization exercise combined with taping is beneficial and effective in managing wrist pain and disability in postpartum women with wrist pain.",2021,Significant improvement in the SF-36 score was observed in the WSE + TT and WSE groups compared to that in the control group ( p < 0.05).,"['postpartum women with wrist pain', 'Postpartum Women with Wrist Pain', 'Forty-five patients with wrist pain']","['wrist stabilization exercise + taping therapy (WSE + TT', 'WSE + TT', 'wrist stabilization exercise (WSE', 'Taping Combined with Wrist Stabilization Exercise', 'wrist stabilization exercise combined with taping', 'control group performed passive range of motion (P-ROM) exercise']","['degree of wrist disability and quality of life', 'SF-36 score', 'visual analogue scale (VAS', 'pain level of the wrist', 'wrist pain and functional disability', 'wrist pain, disability, and quality of life', 'Pain, Disability, and Quality of Life']","[{'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0221785', 'cui_str': 'Pain in wrist'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0221785', 'cui_str': 'Pain in wrist'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",45.0,0.0164205,Significant improvement in the SF-36 score was observed in the WSE + TT and WSE groups compared to that in the control group ( p < 0.05).,"[{'ForeName': 'Kyoung-Sim', 'Initials': 'KS', 'LastName': 'Jung', 'Affiliation': 'Department of Physical Therapy, Gimcheon University, Gimcheon 39528, Korea.'}, {'ForeName': 'Jin-Hwa', 'Initials': 'JH', 'LastName': 'Jung', 'Affiliation': 'Department of Occupational Therapy, Semyung University, Jecheon 27136, Korea.'}, {'ForeName': 'Hyung-Soo', 'Initials': 'HS', 'LastName': 'Shin', 'Affiliation': 'Department of Physical Therapy, Kyungwoon University, Gumi 39160, Korea.'}, {'ForeName': 'Jae-Young', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, Kyungwoon University, Gumi 39160, Korea.'}, {'ForeName': 'Tae-Sung', 'Initials': 'TS', 'LastName': 'In', 'Affiliation': 'Department of Physical Therapy, Gimcheon University, Gimcheon 39528, Korea.'}, {'ForeName': 'Hwi-Young', 'Initials': 'HY', 'LastName': 'Cho', 'Affiliation': 'Department of Physical Therapy, College of Health Science, Gachon University, Incheon 21936, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph18073564'] 2933,33808079,The Effects of Spirulina Supplementation on Redox Status and Performance Following a Muscle Damaging Protocol.,"Spirulina plantensis is a popular supplement which has been shown to have antioxidant and performance enhancing properties. The purpose of this study was to evaluate the effects of spirulina supplementation on (a) redox status (b) muscle performance and (c) muscle damage following an eccentric bout of exercise that would induce muscle damage. Twenty-four healthy, recreationally trained males participated in the study and were randomly separated into two groups: a spirulina supplementation (6 g per day) and a placebo group. Both groups performed an eccentric bout of exercise consisting of 5 sets and 15 maximum reps per set. Blood was collected at 24, 48, 72 and 96 h after the bout and total antioxidant capacity (TAC) and protein carbonyls (PC) were assessed in plasma. Delayed onset muscle soreness (DOMS) was also assessed at the same aforementioned time points. Eccentric peak torque (EPT) was evaluated immediately after exercise, as well as at 24, 48, 72 and 96 h post exercise. Redox status indices (TAC and PC) did not change significantly at any time point post exercise. DOMS increased significantly 24 h post exercise and remained elevated until 72 h and 96 h post exercise for the placebo and spirulina group, respectively. EPT decreased significantly and immediately post exercise and remained significantly lower compared to baseline until 72 h post exercise. No significant differences between groups were found for DOMS and EPT. These results indicate that spirulina supplementation following a muscle damaging protocol does not confer beneficial effects on redox status, muscle performance or damage.",2021,"DOMS increased significantly 24 h post exercise and remained elevated until 72 h and 96 h post exercise for the placebo and spirulina group, respectively.","['Twenty-four healthy, recreationally trained males participated in the study']","['Spirulina Supplementation', 'placebo', 'spirulina supplementation']","['DOMS', 'Redox status indices (TAC and PC', 'EPT', 'DOMS and EPT', 'Redox Status and Performance', 'redox status, muscle performance or damage', 'Eccentric peak torque (EPT', 'Delayed onset muscle soreness (DOMS', 'total antioxidant capacity (TAC) and protein carbonyls (PC']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0075026', 'cui_str': 'Spirulina'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0010957', 'cui_str': 'Damage'}]",,0.0645688,"DOMS increased significantly 24 h post exercise and remained elevated until 72 h and 96 h post exercise for the placebo and spirulina group, respectively.","[{'ForeName': 'Aggelos', 'Initials': 'A', 'LastName': 'Pappas', 'Affiliation': 'Department of Physical Education and Sport Science, University of Thessaly, 42100 Trikala, Greece.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Tsiokanos', 'Affiliation': 'Department of Physical Education and Sport Science, University of Thessaly, 42100 Trikala, Greece.'}, {'ForeName': 'Ioannis G', 'Initials': 'IG', 'LastName': 'Fatouros', 'Affiliation': 'Department of Physical Education and Sport Science, University of Thessaly, 42100 Trikala, Greece.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Poulios', 'Affiliation': 'Department of Physical Education and Sport Science, University of Thessaly, 42100 Trikala, Greece.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Kouretas', 'Affiliation': 'Department of Biochemistry and Biotechnology, University of Thessaly, 41500 Larissa, Greece.'}, {'ForeName': 'Nikos', 'Initials': 'N', 'LastName': 'Goutzourelas', 'Affiliation': 'Department of Biochemistry and Biotechnology, University of Thessaly, 41500 Larissa, Greece.'}, {'ForeName': 'Giannis', 'Initials': 'G', 'LastName': 'Giakas', 'Affiliation': 'Department of Physical Education and Sport Science, University of Thessaly, 42100 Trikala, Greece.'}, {'ForeName': 'Athanasios Z', 'Initials': 'AZ', 'LastName': 'Jamurtas', 'Affiliation': 'Department of Physical Education and Sport Science, University of Thessaly, 42100 Trikala, Greece.'}]",International journal of molecular sciences,['10.3390/ijms22073559'] 2934,33808030,The Influence of Reducing Diets on Changes in Thyroid Parameters in Women Suffering from Obesity and Hashimoto's Disease.,"Hashimoto's disease is listed among the most common endocrine causes of obesity. As treatment of obesity in women with Hashimoto's disease is frequently unsuccessful, the aim of this study was to evaluate the effectiveness of two different reducing diets and their influence on changes in thyroid parameters in female patients. A six-month observational/interventional study was performed on 100 women aged 18-65 years, previously diagnosed with Hashimoto's disease and obesity and receiving L-thyroxine. The women were randomly assigned to the test group (group A, n = 50) following elimination/reducing diets, and the control group (group B, n = 50) following reducing diets with the same caloric content (without elimination). Anthropometric and thyroid parameters were evaluated at the beginning, after 3 months and after 6 months of treatment. In both groups a significant decrease in BMI and body fat percentage was achieved, but in test group A the decrease in BMI and body fat percentage was significantly greater than in control group B ( p < 0.002 and p = 0.026, respectively). Serum TSH (thyroid stimulating hormon) levels decreased significantly more in group A than in group B ( p < 0.001). Group A exhibited significantly greater increases in fT4 and fT3 levels than the control group ( p < 0.001) as well as significantly greater decreases in the levels anti-TPO (thyroid peroxidase) ( p < 0.001) and anti-TG (thyreoglobulin) antibodies ( p = 0.048). The application of reducing diets with product elimination was found to be a more beneficial tool for changing anthropometric and thyroid parameters in women suffering from obesity and Hashimoto's disease than classic reducing diets with the same energy values and macronutrient content.",2021,Group A exhibited significantly greater increases in fT4 and fT3 levels than the control group ( p < 0.001) as well as significantly greater decreases in the levels anti-TPO (thyroid peroxidase) ( p < 0.001) and anti-TG (thyreoglobulin) antibodies ( p = 0.048).,"[""Women Suffering from Obesity and Hashimoto's Disease"", ""100 women aged 18-65 years, previously diagnosed with Hashimoto's disease and obesity and receiving L-thyroxine"", ""women with Hashimoto's disease"", ""women suffering from obesity and Hashimoto's disease than classic reducing diets"", 'female patients']","['Reducing Diets', 'elimination/reducing diets, and the control group (group B, n = 50) following reducing diets with the same caloric content (without elimination']","['levels anti-TPO (thyroid peroxidase', 'BMI and body fat percentage', 'fT4 and fT3 levels', 'Serum TSH (thyroid stimulating hormon) levels', 'anti-TG (thyreoglobulin) antibodies', 'Anthropometric and thyroid parameters']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0677607', 'cui_str': 'Hashimoto thyroiditis'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0012167', 'cui_str': 'Weight reduction diet'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0012167', 'cui_str': 'Weight reduction diet'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021965', 'cui_str': 'Iodide peroxidase'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0560014', 'cui_str': 'ft3'}, {'cui': 'C1277938', 'cui_str': 'Serum TSH measurement'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",100.0,0.011985,Group A exhibited significantly greater increases in fT4 and fT3 levels than the control group ( p < 0.001) as well as significantly greater decreases in the levels anti-TPO (thyroid peroxidase) ( p < 0.001) and anti-TG (thyreoglobulin) antibodies ( p = 0.048).,"[{'ForeName': 'Lucyna', 'Initials': 'L', 'LastName': 'Ostrowska', 'Affiliation': 'Department of Dietetics and Clinical Nutrition, Medical University of Bialystok, ul. Mieszka I 4 B, 15-054 Bialystok, Poland.'}, {'ForeName': 'Dominika', 'Initials': 'D', 'LastName': 'Gier', 'Affiliation': 'Faculty of Physiotherapy and Health Sciences, Gdansk College of Health, ul. Pelplińska 7, 80-335 Gdańsk, Poland.'}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Zyśk', 'Affiliation': 'Department of Dietetics and Clinical Nutrition, Medical University of Bialystok, ul. Mieszka I 4 B, 15-054 Bialystok, Poland.'}]",Nutrients,['10.3390/nu13030862'] 2935,33246104,Effect of pilates exercises on premenstrual syndrome symptoms: a quasi-experimental study.,"OBJECTIVES This study was done to identify the effect of pilates exercises on the symptoms of premenstrual syndrome. DESIGN A quasi experimental was conducted on university student with premenstrual syndrome. METHODS Population of the study included midwifery students with premenstrual syndrome at Istanbul University Faculty of Health Sciences (N = 286) and 50 of them became the sample (25 in experimental group and 25 in control group). Non-probablistic sampling method was used. While the students in experimental group were asked to practice the pilates exercises for three months, the students in control group were told to maintain their routine habits. At the end of the three months, premenstrual syndrome problem of experimental and control group was diagnosed and the effect of pilates on premenstrual syndrome was evaluated. Premenstrual Syndrome symptoms were evaluated through Premenstrual Syndrome Scale (PMSS). The high score received from PMSS shows that the symptoms are intensive. RESULTS It was seen that the students in the experimental and control group were similar in terms of their aspects which were individual, health and could affect premenstrual syndrome (p > 005). A statistical significant difference was not found between total scores and sub-dimension scores of PMSS in experimental and control group (p < 0.05). It was seen that PMSS total score of experimental group was significantly lower than that of control group (p < 0.001). When in-group comparisons were examined, it was identified that PMSS scores of control group did not change at the beginning and end of exercise, but PMSS score of experimental group at the end of exercise was lower than their score received at the beginning of exercise and, the difference was statistically significant to the highest degree (p < 0.001). CONCLUSION It was seen that the pilates exercises, which were practiced in this research, decreased the PMS symptoms considerably. In this regard, the pilates exercises have an important role in healing the PMS symptoms.",2021,A statistical significant difference was not found between total scores and sub-dimension scores of PMSS in experimental and control group (p < 0.05).,"['university student with premenstrual syndrome', 'Population of the study included midwifery students with premenstrual syndrome at Istanbul University Faculty of Health Sciences']",['pilates exercises'],"['Premenstrual Syndrome symptoms', 'total scores and sub-dimension scores of PMSS', 'PMSS scores', 'PMSS score', 'premenstrual syndrome', 'Premenstrual Syndrome Scale (PMSS', 'PMSS total score']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0033046', 'cui_str': 'Premenstrual syndrome'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}]","[{'cui': 'C1321049', 'cui_str': 'Pilates exercise'}]","[{'cui': 'C0033046', 'cui_str': 'Premenstrual syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0160664,A statistical significant difference was not found between total scores and sub-dimension scores of PMSS in experimental and control group (p < 0.05).,"[{'ForeName': 'Elif Tuğçe', 'Initials': 'ET', 'LastName': 'Çitil', 'Affiliation': 'Department of Midwifery, Health Science Faculty, Kütahya Health Science University, in Kütahya, Turkey. Electronic address: eliftugce.citil@ksbu.edu.tr.'}, {'ForeName': 'Nurten', 'Initials': 'N', 'LastName': 'Kaya', 'Affiliation': 'Department of Midwifery, Health Science Faculty, İstanbul University-Cerrahpaşa in İstanbul, Turkey. Electronic address: nurka@istanbul.edu.tr.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102623'] 2936,33246270,CT-based radiomics for predicting brain metastases as the first failure in patients with curatively resected locally advanced non-small cell lung cancer.,"PURPOSE Brain metastasis (BM) is the primary first failure pattern in patients with curatively resected locally advanced non-small cell lung cancer (LA-NSCLC). It is not yet possible to accurately predict the occurrence of BM. The purpose of the research is to develop and validate a prediction model of BM-free survival based on radiomics characterising the primary lesions combined with clinical characteristics in patients with curatively resected LA-NSCLC. METHODS This study consisted of 124 patients with curatively resected stage IIB-IIIB NSCLC in our institution between January 2014 and June 2018. Patients were randomly divided into training and validation cohorts using a 4:1 ratio. Radiomics features were selected from the chest CT images before surgery. A radiomics signature was constructed using the LASSO algorithm based on the training cohort. Clinical model was developed using the Cox proportional hazards model. The clinical, radiomics, and integrated nomograms were constructed. The prediction performance of the models was assessed based on its discrimination, calibration, and clinical utility. RESULTS The radiomics signature is significantly associated with BM-free survival in the overall cohort. The discrimination performance of the integrated nomogram, with the C-indexes 0.889 (0.872-0.906, 95 % CI) and 0.853 (0.788-0.918, 95 % CI) in the training and validation cohorts, respectively, is significantly better than the clinical nomogram (p < 0.0001 for the training cohort, p = 0.0008 for the validation cohort). Compared with the radiomics nomogram, the integrated nomogram is also improved to varying degrees, but not apparent in the validation cohort (p = 0.0007 for the training cohort, p = 0.0554 for the validation cohort). The calibration curve and decision curve analysis demonstrated that the integrated nomogram exceeded the clinical or radiomics nomograms in predicting BM-free survival. CONCLUSIONS Compared with the clinical or radiomics nomograms, the predictive performance of the integrated nomogram is significantly improved. The integrated nomogram is most suitable for predicting BM-free survival in patients with curatively resected LA-NSCLC.",2021,"The discrimination performance of the integrated nomogram, with the C-indexes 0.889 (0.872-0.906, 95 % CI) and 0.853 (0.788-0.918, 95 % CI) in the training and validation cohorts, respectively, is significantly better than the clinical nomogram (p < 0.0001 for the training cohort, p = 0.0008 for the validation cohort).","['patients with curatively resected locally advanced non-small cell lung cancer (LA-NSCLC', '124 patients with curatively resected stage IIB-IIIB NSCLC in our institution between January 2014 and June 2018', 'patients with curatively resected LA-NSCLC', 'patients with curatively resected locally advanced non-small cell lung cancer']",['CT-based radiomics'],['BM-free survival'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0441769', 'cui_str': 'Stage 2B'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",124.0,0.033608,"The discrimination performance of the integrated nomogram, with the C-indexes 0.889 (0.872-0.906, 95 % CI) and 0.853 (0.788-0.918, 95 % CI) in the training and validation cohorts, respectively, is significantly better than the clinical nomogram (p < 0.0001 for the training cohort, p = 0.0008 for the validation cohort).","[{'ForeName': 'Fenghao', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'School of Clinical Medicine, Weifang Medical University, Weifang, Shandong, China; Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Science, Jinan, Shandong, China. Electronic address: 18366120520@163.com.'}, {'ForeName': 'Yicong', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Science, Jinan, Shandong, China; Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Nuclear Medicine, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Science, Jinan, Shandong, China; Department of Graduate, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong, China.'}, {'ForeName': 'Xiaorong', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Nuclear Medicine, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Science, Jinan, Shandong, China; Department of Graduate, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong, China. Electronic address: 251400067@qq.com.'}, {'ForeName': 'Ligang', 'Initials': 'L', 'LastName': 'Xing', 'Affiliation': 'School of Clinical Medicine, Weifang Medical University, Weifang, Shandong, China; Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Science, Jinan, Shandong, China; Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China; Department of Graduate, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong, China. Electronic address: xinglg@medmail.com.cn.'}]",European journal of radiology,['10.1016/j.ejrad.2020.109411'] 2937,33247703,The Effects of Text Message and Infographic on Reducing the Number Cigarettes Consumption: A Randomized Controlled Trial.,"OBJECTIVE To test the effect of a text-message and infographic to promote smokers quit smoking.

Methods: A randomized control trial was conducted in two provinces of northeast Thailand. Three hundred and ninety-six participants were allocated to either a text-message and infographic group or a control group. We assessed the primary outcome by self-reported 7-day point prevalence smoking abstinence. Multiple logistic regression was used to test the effect of quitting smoking.

Results: At 3-month follow-up, lost to follow-up 16 participants, 380 participants were included for analysis. The difference in the rate of quitting smoking between the intervention and control groups was not found a statistical significance (17.8% versus 11.6%). However, we found a statistically significant difference in the number of cigarettes smokes (the difference: -1.74; 95%CI: -2.63, -0.84).

Conclusion: No effect of text message and infographic for help smokers to quit smoking. However, the intervention showed a decrease in the number of cigarettes smoked.",2020,Three hundred and ninety-six participants were allocated to either a text-message and infographic group or a control group.,"['two provinces of northeast Thailand', 'Three hundred and ninety-six participants', 'help smokers to quit smoking', '16 participants, 380 participants were included for analysis', 'smokers quit smoking']","['Methods', 'text-message and infographic', 'Text Message and Infographic', 'Conclusion', 'text-message and infographic group or a control group', 'text message and infographic']","['Number Cigarettes Consumption', 'rate of quitting smoking', 'self-reported 7-day point prevalence smoking abstinence', 'number of cigarettes smokes', 'number of cigarettes smoked']","[{'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C5191354', 'cui_str': '396'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C4319693', 'cui_str': '380'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}]",396.0,0.11239,Three hundred and ninety-six participants were allocated to either a text-message and infographic group or a control group.,"[{'ForeName': 'Nirun', 'Initials': 'N', 'LastName': 'Intarut', 'Affiliation': 'Health Systems Science Unit, Faculty of Medicine, Mahasarakham University, Muang, Maha Sarakham, Thailand.'}, {'ForeName': 'Ranee', 'Initials': 'R', 'LastName': 'Wongkongdech', 'Affiliation': 'Health Systems Science Unit, Faculty of Medicine, Mahasarakham University, Muang, Maha Sarakham, Thailand.'}, {'ForeName': 'Chollada', 'Initials': 'C', 'LastName': 'Thronsao', 'Affiliation': 'Emergency Medical Operation, Faculty of Medicine, Mahasarakham University, Muang, Maha Sarakham, Thailand.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2020.21.11.3413'] 2938,33248115,Percent Body Fat Content Measured by Plethysmography in Infants Randomized to High- or Usual-Volume Feeding after Very Preterm Birth.,We measured percent body fat by air-displacement plethysmography in 86 infants born at <32 weeks of gestation randomized to receive either high-volume (180-200 mL/kg/day) or usual volume feeding (140-160 mL/kg/day). High-volume feeding increased percent body fat by ≤2% at 36 weeks of postmenstrual age (within a predefined range of equivalence). TRIAL REGISTRATION: ClincialTrials.gov: NCT02377050.,2021,,[],[],['Percent Body Fat Content'],[],[],"[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",,0.0258087,,"[{'ForeName': 'Ariel A', 'Initials': 'AA', 'LastName': 'Salas', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of Alabama at Birmingham, Birmingham, AL. Electronic address: asalas@peds.uab.edu.'}, {'ForeName': 'Colm P', 'Initials': 'CP', 'LastName': 'Travers', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Maggie L', 'Initials': 'ML', 'LastName': 'Jerome', 'Affiliation': 'Department of Nutrition Sciences, School of Health Professions, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Chandler-Laney', 'Affiliation': 'Department of Nutrition Sciences, School of Health Professions, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Waldemar A', 'Initials': 'WA', 'LastName': 'Carlo', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of Alabama at Birmingham, Birmingham, AL.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.11.028'] 2939,33816798,Handoffs and Nurse Calls: Overnight Call Simulation for Fourth-Year Medical Students.,"Introduction Interns must be able to give and receive handoffs and use handoff information to respond to calls from nursing staff regarding patient concerns. Medical students may not receive adequate instruction in these tasks and often feel unprepared in this aspect of transitioning to residency. This program simulated an overnight call experience for fourth-year medical students emphasizing handoffs, nurse calls, and medical emergency response. Methods The program utilized a combination of traditional didactics and simulated handoffs, nurse calls, and patient scenarios to allow groups of fourth-year medical students to independently manage a simulated overnight call. The program was designed for students as part of a larger Transition to Residency capstone course. Results We ran four sessions over 3 years, with a total of 105 medical student participants. All students reported increased confidence or comfort in their ability to manage handoffs and respond to nurse calls. Students reported that the sessions were helpful and realistic. Discussion This program provided fourth-year medical students with a realistic and useful opportunity to simulate handoffs and response to nurse calls, which increased their confidence and comfort. Minor changes were made between iterations of the course with continued positive feedback from medical students. The course is generalizable and can be adapted to the needs and resources of different institutions.",2021,"This program provided fourth-year medical students with a realistic and useful opportunity to simulate handoffs and response to nurse calls, which increased their confidence and comfort.","['105 medical student participants', 'Fourth-Year Medical Students']",[],['confidence or comfort'],"[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",105.0,0.040601,"This program provided fourth-year medical students with a realistic and useful opportunity to simulate handoffs and response to nurse calls, which increased their confidence and comfort.","[{'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Assistant Professor, Division of Emergency Medicine, Saint Louis University School of Medicine.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Stapleton', 'Affiliation': 'Assistant Professor, Department of Emergency Medicine, Boston University School of Medicine.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Babcock', 'Affiliation': 'Assistant Professor, Department of Emergency Medicine, University of Connecticut School of Medicine.'}, {'ForeName': 'Mariann Nocera', 'Initials': 'MN', 'LastName': 'Kelley', 'Affiliation': ""Assistant Professor, Departments of Pediatrics and Emergency Medicine/Traumatology, Division of Pediatric Emergency Medicine, University of Connecticut School of Medicine and Connecticut Children's Medical Center; Director of Simulation Education, University of Connecticut School of Medicine.""}, {'ForeName': 'Alise', 'Initials': 'A', 'LastName': 'Frallicciardi', 'Affiliation': 'Associate Professor, Department of Emergency Medicine, University of Connecticut School of Medicine; Emergency Department Medical Director, University of Connecticut John Dempsey Hospital.'}]",MedEdPORTAL : the journal of teaching and learning resources,['10.15766/mep_2374-8265.11138'] 2940,33814891,Barriers and Facilitators to Lifestyle Intervention Engagement and Weight Loss in People Living With Spinal Cord Injury.,"Background: Individuals living with spinal cord injury (SCI) have a high prevalence of obesity and unique barriers to healthy lifestyle. Objective: To examine barriers and facilitators to engagement and weight loss among SCI participants enrolled in the Group Lifestyle Balance Adapted for individuals with Impaired Mobility (GLB-AIM), a 12-month intensive lifestyle intervention. Methods: SCI participants (N = 31) enrolled in a wait-list, randomized controlled trial where all participants received intervention between August 2015 and February 2017. Analyses of pooled data occurred in 2020 to examine cross-sectional and prospective associations of hypothesized barriers and facilitators with (1) intervention engagement, comprised of attendance and self-monitoring, and (2) percent weight change from baseline to 12 months. We performed multivariable linear regression on variables associated with outcomes at p < .05 in bivariate analyses and controlled for intervention group. Results: Participants were middle-aged (mean age, 48.26 ± 11.01 years), equally male (50%) and female, White (80.7%), and unemployed (65.6%). In participants who completed baseline surveys ( n = 30), dietary self-efficacy explained 26% of variance in engagement ( p < .01); among the 12-month study completers ( n = 22, 71.0%), relationship issues explained 23% of variance in engagement ( p < .01). Money problems, health issues unrelated to SCI, lack of motivation, and experimental group explained 57% of variance in weight loss ( p for model < .01), with lack of motivation uniquely explaining 24% of variance (p < .01). Conclusion: Improving engagement and weight loss for persons with SCI in the GLBAIM program may be achieved by addressing lack of motivation, relationship issues, and nutrition self-efficacy.",2021,"In participants who completed baseline surveys ( n = 30), dietary self-efficacy explained 26% of variance in engagement ( p < .01); among the 12-month study completers ( n = 22, 71.0%), relationship issues explained 23% of variance in engagement ( p < .01).","['Individuals living with spinal cord injury (SCI', 'SCI participants (N = 31) enrolled in a wait-list, randomized controlled trial where all participants received intervention between August 2015 and February 2017', 'SCI participants enrolled in the Group Lifestyle Balance Adapted for individuals with Impaired Mobility (GLB-AIM), a 12-month intensive lifestyle intervention', 'persons with SCI', 'Participants were middle-aged (mean age, 48.26 ± 11.01 years), equally male (50%) and female, White (80.7%), and unemployed (65.6', 'People Living With Spinal Cord Injury']",[],"['dietary self-efficacy', 'weight loss']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0518456', 'cui_str': 'Impaired mobility'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0041674', 'cui_str': 'Unemployed'}]",[],"[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.0529694,"In participants who completed baseline surveys ( n = 30), dietary self-efficacy explained 26% of variance in engagement ( p < .01); among the 12-month study completers ( n = 22, 71.0%), relationship issues explained 23% of variance in engagement ( p < .01).","[{'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Betts', 'Affiliation': 'Department of Health Promotion and Behavioral Sciences, University of Texas Health Science Center at Houston, School of Public Health, Dallas, Texas.'}, {'ForeName': 'Christa', 'Initials': 'C', 'LastName': 'Ochoa', 'Affiliation': 'Baylor Scott & White Institute for Rehabilitation, Dallas, Texas.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Hamilton', 'Affiliation': 'Baylor Scott & White Institute for Rehabilitation, Dallas, Texas.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Sikka', 'Affiliation': 'Baylor Scott & White Institute for Rehabilitation, Dallas, Texas.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Froehlich-Grobe', 'Affiliation': 'Baylor Scott & White Institute for Rehabilitation, Dallas, Texas.'}]",Topics in spinal cord injury rehabilitation,['10.46292/sci20-00025'] 2941,33814441,Association of Plasma Hemoglobin A1c with Improvement of Cognitive Functions by Probiotic Bifidobacterium breve Supplementation in Healthy Adults with Mild Cognitive Impairment.,"We demonstrated the benefit of the probiotic strain, Bifidobacterium breve MCC1274 (synonym B. breve A1), at improving cognition in our previous double-blind, placebo-controlled clinical study. Analysis of the association of blood parameters changes with the improvement of cognitive function revealed an inverse correlation of HbA1c with total RBANS score amelioration after the study only in the probiotic group (ρ= -0. 4218, p = 0.0067). A stratified analysis based on baseline HbA1c with a median value showed a more remarkable benefit by the probiotic supplementation in the higher median subgroup. These data support the mechanism of anti-inflammation in improving cognition by the probiotic strain.",2021,A stratified analysis based on baseline HbA1c with a median value showed a more remarkable benefit by the probiotic supplementation in the higher median subgroup.,['Healthy Adults with Mild Cognitive Impairment'],"['Probiotic Bifidobacterium breve Supplementation', 'placebo', 'probiotic strain, Bifidobacterium breve MCC1274 (synonym B. breve A1']",['HbA1c with total RBANS score amelioration'],"[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0314975', 'cui_str': 'Bifidobacterium breve'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C3541381', 'cui_str': 'Synonym'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.249559,A stratified analysis based on baseline HbA1c with a median value showed a more remarkable benefit by the probiotic supplementation in the higher median subgroup.,"[{'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Bernier', 'Affiliation': 'Morinaga Milk Industry Co., Ltd., Next Generation Science Institute, Kanagawa, Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Ohno', 'Affiliation': 'Morinaga Milk Industry Co., Ltd., Next Generation Science Institute, Kanagawa, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Katsumata', 'Affiliation': 'Morinaga Milk Industry Co., Ltd., Next Generation Science Institute, Kanagawa, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Shimizu', 'Affiliation': 'Morinaga Milk Industry Co., Ltd., Next Generation Science Institute, Kanagawa, Japan.'}, {'ForeName': 'Jinzhong', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': 'Morinaga Milk Industry Co., Ltd., Next Generation Science Institute, Kanagawa, Japan.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-201488'] 2942,33814437,"β-Lactolin Enhances Neural Activity, Indicated by Event-Related P300 Amplitude, in Healthy Adults: A Randomized Controlled Trial.","BACKGROUND Epidemiological studies have shown that dairy product consumption is beneficial for cognitive function in elderly individuals. β-lactolin is a lacto-tetrapeptide Gly-Thr-Trp-Tyr rich in fermented dairy products that improves memory retrieval, attention, and executive function in older adults with subjective cognitive decline and prevents the pathology of Alzheimer's disease in rodents. There has been no study on the effects of β-lactolin on neural activity in humans. OBJECTIVE We investigated the effects of β-lactolin on neural activity and cognitive function in healthy adults. METHODS In this randomized, double-blind, placebo-controlled study, 30 participants (45-64 years old) consumed β-lactolin or placebo for 6 weeks. Neural activity during auditory and language tasks was measured through 64-channel electroencephalography. Moreover, verbal fluency tests were performed at baseline and after 6 weeks. RESULTS The β-lactolin group had a significantly higher P300 amplitude at the Cp2 site (a part of the parietal lobe near the center of brain, p = 0.008), and C4 site (the area between the frontal and parietal lobe, p = 0.021) during the auditory tasks after 6 weeks than the placebo group. Thus, β-lactolin supplementation promoted neural activity in the parietal area, which increases attention during auditory cognitive tasks. Compared with the placebo group, the β-lactolin group also showed significant changes in the scores of verbal fluency test after 6 weeks (p = 0.03). CONCLUSION Our findings provide insight into the mechanisms underlying the effects of β-lactolin on attention in healthy adults.",2021,"Compared with the placebo group, the β-lactolin group also showed significant changes in the scores of verbal fluency test after 6 weeks (p = 0.03). ","['Healthy Adults', ""older adults with subjective cognitive decline and prevents the pathology of Alzheimer's disease in rodents"", '30 participants (45-64 years old) consumed', 'elderly individuals', 'healthy adults']","['β-lactolin or placebo', 'placebo', 'β-lactolin', 'β-Lactolin', 'β-lactolin supplementation']","['neural activity and cognitive function', 'P300 amplitude', 'scores of verbal fluency test', 'Neural activity during auditory and language tasks', 'verbal fluency tests', 'memory retrieval, attention, and executive function', 'neural activity']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0035804', 'cui_str': 'Order Rodentia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0444781', 'cui_str': 'P300 (P3)'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",30.0,0.505265,"Compared with the placebo group, the β-lactolin group also showed significant changes in the scores of verbal fluency test after 6 weeks (p = 0.03). ","[{'ForeName': 'Ayana', 'Initials': 'A', 'LastName': 'Kanatome', 'Affiliation': 'Kirin Central Research Institute, Kirin Holdings Company, Ltd., Fujisawa, Kanagawa, Japan.'}, {'ForeName': 'Yasuhisa', 'Initials': 'Y', 'LastName': 'Ano', 'Affiliation': 'Kirin Central Research Institute, Kirin Holdings Company, Ltd., Fujisawa, Kanagawa, Japan.'}, {'ForeName': 'Kazushi', 'Initials': 'K', 'LastName': 'Shinagawa', 'Affiliation': 'Department of Psychology, Keio University, Mita, Minato-ku, Tokyo, Japan.'}, {'ForeName': 'Yumiko', 'Initials': 'Y', 'LastName': 'Ide', 'Affiliation': 'Tokyo Center Clinic, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Midori', 'Initials': 'M', 'LastName': 'Shibata', 'Affiliation': 'Department of Psychology, Keio University, Mita, Minato-ku, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Umeda', 'Affiliation': 'Department of Psychology, Keio University, Mita, Minato-ku, Tokyo, Japan.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-201413'] 2943,33781388,Effects of a Quality Improvement Program to Reduce Central Venous Catheter-Related Infections in Hemodialysis Patients.,"BACKGROUND Central catheter infections are of concern in patients on hemodialysis because of the high risk of catheter-related bloodstream infections, sepsis, and death. Adequate nursing is critical for the prevention of such infections. This study aimed to use the PDCA (plan-do-check-act) method to reduce the incidence of central venous catheter infection using management in the maintenance of central venous catheter in patients on hemodialysis, compared with routine care. METHODS This pilot study recruited patients on hemodialysis via central venous catheterization at the Blood Purification Center of Ruijin Hospital between November 2017 and November 2018. The patients were randomized to the routine and PDCA groups. All participants received routine nursing. The PDCA group received central venous catheter management by PDCA. The incidence of central venous catheterization-related infections, nursing satisfaction, and quality of life were compared between the two groups. RESULTS A total of 122 participants were enrolled in each group. The incidence of central catheter-related bloodstream infection, as the primary outcome, was 0.8 and 8.8 cases per 1000 catheter days in the PDCA and routine groups, respectively (P < 0.001). In addition, as the secondary outcomes, the scores of nursing satisfaction (health guidance, nursing technology, and therapeutic effects) score and quality of life (physiological, psychological, social, and environmental status) were better in the PDCA group than in the routine group (all P < 0.01). CONCLUSIONS This pilot study suggests that the PDCA cycle model can effectively reduce the incidence of central venous catheter-related infections and improve satisfaction and quality of life in patients on hemodialysis.",2021,"The incidence of central venous catheterization-related infections, nursing satisfaction, and quality of life were compared between the two groups. ","['patients on hemodialysis, compared with routine care', 'A total of 122 participants were enrolled in each group', 'Hemodialysis Patients', 'patients on hemodialysis', 'patients on hemodialysis via central venous catheterization at the Blood Purification Center of Ruijin Hospital between November 2017 and November 2018']","['central venous catheter management by PDCA', 'PDCA', 'PDCA (plan-do-check-act', 'routine nursing', 'Quality Improvement Program']","['scores of nursing satisfaction (health guidance, nursing technology, and therapeutic effects) score and quality of life (physiological, psychological, social, and environmental status', 'satisfaction and quality of life', 'incidence of central venous catheterization-related infections, nursing satisfaction, and quality of life', 'incidence of central catheter-related bloodstream infection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007435', 'cui_str': 'Central venous catheterisation'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0243114', 'cui_str': 'purification'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C1145640', 'cui_str': 'Central venous catheter'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0007435', 'cui_str': 'Central venous catheterisation'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C2886794', 'cui_str': 'Catheter related bloodstream infection'}]",122.0,0.0402471,"The incidence of central venous catheterization-related infections, nursing satisfaction, and quality of life were compared between the two groups. ","[{'ForeName': 'Zhenhua', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Nephrology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaobo', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Department of Nephrology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China. Electronic address: mxb11598@rjh.com.cn.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Nephrology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yiqing', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Department of Nephrology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Qianyu', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Nephrology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaoting', 'Initials': 'X', 'LastName': 'Pan', 'Affiliation': 'Department of Nephrology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}]",The American journal of the medical sciences,['10.1016/j.amjms.2020.10.018'] 2944,33780563,Classroom-based physical activity and math performance: Integrated physical activity or not?,"AIM This 8-week intervention examined the effect of two different types of classroom-based physical activity on math performance in elementary school children. METHODS Students in 4th and 5th grade (N = 560; 32 classes, 9-11 years old) from six schools were assigned to integrated physical activity (Move for Thought [M4T], n = 221), activity break (AB; n = 134) and a control group (n = 205; usual instruction) for eight weeks. Students completed a standardised math test before and after the intervention. Programme fidelity was measured with a teacher daily log, recording the duration and frequency of the physical activity sessions. Linear mixed models were used for the analyses. Grade and gender were explored as moderators. RESULTS Move for Thought group outperformed AB (p < 0.001, d = 0.44) and control groups (p = 0.013, d = 0.38). However, subgroup analyses showed that these effects were evident only in Grade 4. No gender differences were found. Intervention fidelity showed that the classroom-based physical activities (M4T and AB) were used about every other day, with higher implementation among 4th graders. CONCLUSION This study indicated that integrating physical activity with mathematics has stronger effects on mathematics than activity breaks and traditional instruction.",2021,"RESULTS M4T group outperformed AB (p < 0.001, d = 0.44) and control groups (p = 0.013, d = 0.38).","['Students in 4 th and 5 th grade (N = 560; 32 classes, 9-11 years old) from six schools', 'elementary school children']","['Classroom-based physical activity and math performance: Integrated physical activity or not', 'integrated physical activity', 'classroom-based physical activities (M4T and AB', 'classroom-based physical activity']",['Program fidelity'],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0260267', 'cui_str': 'School child'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}]",,0.0142348,"RESULTS M4T group outperformed AB (p < 0.001, d = 0.44) and control groups (p = 0.013, d = 0.38).","[{'ForeName': 'Myrto F', 'Initials': 'MF', 'LastName': 'Mavilidi', 'Affiliation': 'Early Start, School of Education, University of Wollongong, Keiraville, NSW, Australia.'}, {'ForeName': 'Spyridoula', 'Initials': 'S', 'LastName': 'Vazou', 'Affiliation': 'Department of Kinesiology, Iowa State University, Ames, IA, USA.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15860'] 2945,33780481,"An open label, randomized clinical trial to compare the tolerability and efficacy of ivermectin plus diethylcarbamazine and albendazole vs. diethylcarbamazine plus albendazole for treatment of brugian filariasis in Indonesia.","Improved treatments for lymphatic filariasis (LF) could accelerate the global elimination program for this disease. A triple drug combination of the anti-filarial drugs ivermectin, diethylcarbamazine (DEC) and albendazole (IDA) has been shown to be safe and effective for achieving sustained clearance of microfilariae (Mf) of the filarial parasite Wuchereria bancrofti from human blood. However, the triple drug combination has not been previously been evaluated for treatment of brugian filariasis, which accounts for about 10% of the global LF burden. This hospital-based clinical trial compared the safety and efficacy of IDA with that of the standard treatment (DEC plus albendazole, DA) in persons with Brugia timori infections on Sumba island, Indonesia. Fifty-five asymptomatic persons with B. timori Mf were treated with either a single oral dose of IDA (28 subjects) or with DEC plus albendazole (DA, 27 subjects). Participants were actively monitored for adverse events (AE) for two days after treatment by nurses and physicians who were masked regarding treatment assignments. Passive monitoring was performed by clinical teams that visited participant's home villages for an additional five days. Microfilaremia was assessed by membrane filtration of 1 ml night blood at baseline, at 24h and one year after treatment. IDA was more effective than DA for completely clearing Mf at 24 hours (25/28, 89% vs. 8/27, 30%, P < 0.001). By 12 months after treatment, only one of 27 IDA recipients had Mf in their blood (4%) vs. 10 of 25 (40%) in persons treated with DA (P = 0.002). Approximately 90% of participants had antibodies to recombinant filarial antigen BmR1 at baseline. Antibody prevalence decreased to approximately 30% in both treatment groups at 12 months. About 45% of persons in both treatment groups experienced AE such as fever, muscle aches, lower back, joint and abdominal pain. These were mostly mild and most common during the first two days after treatment. No participant experienced a severe or serious AE. This study showed that IDA was well-tolerated and significantly more effective for clearing B. timori Mf from the blood than DA. Larger studies should be performed to further assess the safety and efficacy of IDA as a mass drug administration regimen to eliminate brugian filariasis. Trial Registration: NCT02899936.",2021,"About 45% of persons in both treatment groups experienced AE such as fever, muscle aches, lower back, joint and abdominal pain.","['Fifty-five asymptomatic persons with B. timori Mf', 'brugian filariasis in Indonesia', 'persons with Brugia timori infections on Sumba island, Indonesia']","['standard treatment (DEC plus albendazole, DA', 'DEC plus albendazole', 'ivermectin plus diethylcarbamazine and albendazole vs. diethylcarbamazine plus albendazole', 'IDA', 'ivermectin, diethylcarbamazine (DEC) and albendazole (IDA']","['Microfilaremia', 'adverse events (AE', 'tolerability and efficacy', 'Mf in their blood', 'Antibody prevalence', 'severe or serious AE', 'AE such as fever, muscle aches, lower back, joint and abdominal pain']","[{'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025980', 'cui_str': 'Superfamily Filarioidea microfilaria'}, {'cui': 'C0016085', 'cui_str': 'Disease due to superfamily Filarioidea'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C4552400', 'cui_str': 'Brugia timori infection'}, {'cui': 'C0454741', 'cui_str': 'Sumba'}, {'cui': 'C0022130', 'cui_str': 'Island'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0012191', 'cui_str': 'Diethylcarbamazine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0001911', 'cui_str': 'Albendazole'}, {'cui': 'C0022322', 'cui_str': 'Ivermectin'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0025980', 'cui_str': 'Superfamily Filarioidea microfilaria'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}]",55.0,0.0622119,"About 45% of persons in both treatment groups experienced AE such as fever, muscle aches, lower back, joint and abdominal pain.","[{'ForeName': 'Taniawati', 'Initials': 'T', 'LastName': 'Supali', 'Affiliation': 'Department of Parasitology, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Yenny', 'Initials': 'Y', 'LastName': 'Djuardi', 'Affiliation': 'Department of Parasitology, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Christian', 'Affiliation': 'Department of Parasitology, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Iskandar', 'Affiliation': 'Department of Parasitology, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Rahmat', 'Initials': 'R', 'LastName': 'Alfian', 'Affiliation': 'Department of Parasitology, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Roospita', 'Initials': 'R', 'LastName': 'Maylasari', 'Affiliation': 'Department of Parasitology, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Yossi', 'Initials': 'Y', 'LastName': 'Destani', 'Affiliation': 'Department of Parasitology, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Adriani', 'Initials': 'A', 'LastName': 'Lomiga', 'Affiliation': 'Program Studi Ilmu Kesehatan Masyarakat, Program Pascasarjana, Universitas Nusa Cendana, Kupang, Lasiana, Kelapa lima, Kota Kupang, Indonesia.'}, {'ForeName': 'Dominikus', 'Initials': 'D', 'LastName': 'Minggu', 'Affiliation': 'Nusa Tenggara Timur Provincial Health Office, Oebobo, Kota Kupang, Nusa Tenggara Timur, Indonesia.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Lew', 'Affiliation': 'Division of Biostatistics, Washington University School of Medicine, St. Louis, MO, United States of America.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Bogus', 'Affiliation': 'Infectious Diseases Division, Department of Medicine, Washington University School of Medicine, St. Louis, MO, United States of America.'}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Weil', 'Affiliation': 'Infectious Diseases Division, Department of Medicine, Washington University School of Medicine, St. Louis, MO, United States of America.'}, {'ForeName': 'Peter U', 'Initials': 'PU', 'LastName': 'Fischer', 'Affiliation': 'Infectious Diseases Division, Department of Medicine, Washington University School of Medicine, St. Louis, MO, United States of America.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0009294'] 2946,33782020,"Cost-effectiveness analysis of an intimate partner violence prevention intervention targeting men, women and couples in rural Ethiopia: evidence from the Unite for a Better Life randomised controlled trial.","OBJECTIVES Experience of intimate partner violence (IPV) is associated with adverse health and psychosocial outcomes for women. However, rigorous economic evaluations of interventions targeting IPV prevention are rare. This paper analyses the cost-effectiveness of Unite for a Better Life (UBL), a gender-transformative intervention designed to prevent IPV and HIV risk behaviours among men, women and couples. DESIGN We use an economic evaluation nested within a large-scale cluster randomised controlled trial, analysing financial and economic costs tracked contemporaneously. SETTING UBL was implemented in rural southern Ethiopia between 2013 and 2015. PARTICIPANTS The randomised controlled trial included 6770 households in 64 villages. INTERVENTIONS UBL is an intervention delivered within the context of the Ethiopian coffee ceremony, a culturally established forum for community discussion, and designed to assist participants to build skills for healthy, non-violent, equitable relationships. PRIMARY AND SECONDARY OUTCOME MEASURES This paper reports on the unit cost and cost-effectiveness of the interventions implemented. Cost-effectiveness is measured as the cost per case of past-year physical and/or sexual IPV averted. RESULTS The estimated annualised cost of developing and implementing UBL was 2015 US$296 772, or approximately 2015 US$74 per individual directly participating in the intervention and 2015 US$5 per person annually for each community-level beneficiary (woman of reproductive age in intervention communities). The estimated cost per case of past-year physical and/or sexual IPV averted was 2015 US$2726 for the sample of direct beneficiaries, and 2015 US$194 for the sample of all community-level beneficiaries. CONCLUSIONS UBL is an effective and cost-effective intervention for the prevention of IPV in a low and middle-income country setting. Further research should explore strategies to quantify the positive effects of the intervention across other domains. TRIAL REGISTRATION NUMBER NCT02311699 (ClinicalTrials.gov); AEARCTR-0000211 (AEA Registry).",2021,"This paper analyses the cost-effectiveness of Unite for a Better Life (UBL), a gender-transformative intervention designed to prevent IPV and HIV risk behaviours among men, women and couples. ","['men, women and couples', 'Experience of intimate partner violence (IPV', 'men, women and couples in rural Ethiopia', '6770 households in 64 villages', 'women', 'UBL was implemented in rural southern Ethiopia between 2013 and 2015']",['intimate partner violence prevention intervention'],"['Cost-effectiveness', 'unit cost and cost-effectiveness', 'IPV and HIV risk behaviours', 'annualised cost of developing and implementing UBL']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0166872', 'cui_str': 'Unite resin'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}]","[{'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0166872', 'cui_str': 'Unite resin'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",6770.0,0.120187,"This paper analyses the cost-effectiveness of Unite for a Better Life (UBL), a gender-transformative intervention designed to prevent IPV and HIV risk behaviours among men, women and couples. ","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Leight', 'Affiliation': 'Poverty, Health and Nutrition Division, International Food Policy Research Institute, Washington, DC, USA j.leight@cgiar.org.'}, {'ForeName': 'Negussie', 'Initials': 'N', 'LastName': 'Deyessa', 'Affiliation': 'Addis Ababa University School of Public Health, Addis Ababa, Ethiopia.'}, {'ForeName': 'Vandana', 'Initials': 'V', 'LastName': 'Sharma', 'Affiliation': 'Department of Global Health and Population, Harvard University T H Chan School of Public Health, Boston, Massachusetts, USA.'}]",BMJ open,['10.1136/bmjopen-2020-042365'] 2947,33782018,Protocol for an 'efficient design' cluster randomised controlled trial to evaluate a complex intervention to improve antibiotic prescribing for CHIldren presenting to primary care with acute COugh and respiratory tract infection: the CHICO study.,"INTRODUCTION Respiratory tract infections (RTIs) in children are common and present major resource implications for primary care. Unnecessary use of antibiotics is associated with the development and proliferation of antimicrobial resistance. In 2016, the National Institute for Health Research (NIHR)-funded 'TARGET' programme developed a prognostic algorithm to identify children with acute cough and RTI at very low risk of 30-day hospitalisation and unlikely to need antibiotics. The intervention includes: (1) explicit elicitation of parental concerns, (2) the results of the prognostic algorithm accompanied by prescribing guidance and (3) provision of a printout for carers including safety netting advice. The CHIldren's COugh feasibility study suggested differential recruitment of healthier patients in control practices. This phase III 'efficiently designed' trial uses routinely collected data at the practice level, thus avoiding individual patient consent. The aim is to assess whether embedding a multifaceted intervention into general practitioner (GP) practice Information Technology (IT) systems will result in reductions of antibiotic prescribing without impacting on hospital attendance for RTI. METHODS AND ANALYSIS The coprimary outcomes are (1) practice rate of dispensed amoxicillin and macrolide antibiotics, (2) hospital admission rate for RTI using routinely collected data by Clinical Commissioning Groups (CCGs). Data will be collected for children aged 0-9 years registered at 310 practices (155 intervention, 155 usual care) over a 12-month period. Recruitment and randomisation of practices (using the Egton Medical Information Systems web data management system) is conducted via each CCG stratified for children registered and baseline dispensing rates of each practice. Secondary outcomes will explore intervention effect modifiers. Qualitative interviews will explore intervention usage. The economic evaluation will be limited to a between-arm comparison in a cost-consequence analysis. ETHICS AND DISSEMINATION Research ethics approval was given by London-Camden and Kings Cross Research Ethics Committee (ref:18/LO/0345). This manuscript refers to protocol V.4.0. Results will be disseminated through peer-reviewed journals and international conferences. TRIAL REGISTRATION NUMBER ISRCTN11405239.",2021,Recruitment and randomisation of practices (using the Egton Medical Information Systems web data management system) is conducted via each CCG stratified for children registered and baseline dispensing rates of each practice.,"['children aged 0-9 years registered at 310 practices (155 intervention, 155 usual care) over a 12-month period', 'CHIldren presenting to primary care with acute COugh and respiratory tract infection']","['complex intervention', 'prognostic algorithm accompanied by prescribing guidance and (3) provision of a printout for carers including safety netting advice']","['practice rate of dispensed amoxicillin and macrolide antibiotics, (2) hospital admission rate for RTI using routinely collected data by Clinical Commissioning Groups (CCGs']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C5191352', 'cui_str': '310'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0742857', 'cui_str': 'Acute cough'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0003240', 'cui_str': 'Macrolide antibiotic product'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",,0.0914894,Recruitment and randomisation of practices (using the Egton Medical Information Systems web data management system) is conducted via each CCG stratified for children registered and baseline dispensing rates of each practice.,"[{'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Seume', 'Affiliation': 'Centre for Academic Primary Care, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Bevan', 'Affiliation': 'Centre for Academic Primary Care, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Young', 'Affiliation': 'Bristol Trials Centre (Bristol Randomised Trial Collaboration), Bristol Medical School, University of Bristol, University of Bristol, Bristol, Avon, UK.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Ingram', 'Affiliation': 'Centre for Academic Child Health, Bristol Medical School, Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Clement', 'Affiliation': 'Bristol Trials Centre (Bristol Randomised Trial Collaboration), Bristol Medical School, University of Bristol, University of Bristol, Bristol, Avon, UK.'}, {'ForeName': 'Christie', 'Initials': 'C', 'LastName': 'Cabral', 'Affiliation': 'Centre for Academic Primary Care, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Patricia Jane', 'Initials': 'PJ', 'LastName': 'Lucas', 'Affiliation': 'School for Policy Studies, Unversity of Bristol, Bristol, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Beech', 'Affiliation': 'Regional Antimicrobial Stewardship Lead South West Region, NHS Improvement, London, UK.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'Bristol Trials Centre (Bristol Randomised Trial Collaboration), Bristol Medical School, University of Bristol, University of Bristol, Bristol, Avon, UK.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Horwood', 'Affiliation': 'Centre for Academic Primary Care, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Padraig', 'Initials': 'P', 'LastName': 'Dixon', 'Affiliation': 'Centre for Academic Primary Care, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Martin C', 'Initials': 'MC', 'LastName': 'Gulliford', 'Affiliation': ""King's College London, London, UK.""}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Francis', 'Affiliation': 'School of Primary Care Population Sciences and Medical Education, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Sam T', 'Initials': 'ST', 'LastName': 'Creavin', 'Affiliation': 'Centre for Academic Primary Care, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Athene', 'Initials': 'A', 'LastName': 'Lane', 'Affiliation': 'Bristol Trials Centre (Bristol Randomised Trial Collaboration), Bristol Medical School, University of Bristol, University of Bristol, Bristol, Avon, UK.'}, {'ForeName': 'Alastair D', 'Initials': 'AD', 'LastName': 'Hay', 'Affiliation': 'Centre for Academic Primary Care, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Blair', 'Affiliation': 'Centre for Academic Child Health, Bristol Medical School, Population Health Sciences, University of Bristol, Bristol, UK p.s.blair@bris.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2020-041769'] 2948,33781980,Low-temperature electrocautery reduces adverse effects from secondary cardiac implantable electronic device procedures: Insights from the WRAP-IT trial.,"BACKGROUND Cardiac device procedures require tissue dissection to free existing device lead(s). Common techniques include blunt dissection, standard electrocautery, and low-temperature electrocautery (PlasmaBlade, Medtronic); however, data on the type of electrosurgical tool used and the development of procedure- or lead-related adverse events are limited. OBJECTIVE The purpose of this study was to determine whether standard or low-temperature electrocautery impacts the development of an adverse event. METHODS We evaluated patients enrolled in WRAP-IT (Worldwide Randomized Antibiotic EnveloPe Infection PrevenTion Trial) undergoing cardiac implantable electronic device (CIED) revision, upgrade, or replacement. All adverse events were adjudicated by an independent physician committee. Data were analyzed using Cox proportional hazard regression modeling. RESULTS In total, 5641 patients underwent device revision/upgrade/replacement. Electrocautery was used in 5205 patients (92.3%) (mean age 70.6 ± 12.7 years; 28.8% female), and low-temperature electrocautery was used in 1866 patients (35.9%). Compared to standard electrocautery, low-temperature electrocautery was associated with a 23% reduction in the incidence of a procedure- or lead-related adverse event through 3 years of follow up (hazard ratio [HR] 0.77; 95% confidence interval [CI] 0.65-0.91; P = .002). After controlling for the number of active leads, degree of capsulectomy, degree of lead dissection, and renal dysfunction, low-temperature electrocautery was associated with a 32% lower risk of lead-related adverse events (HR 0.68; 95% CI 0.52-0.89; P = .004). These effects were consistent across a spectrum of lead-related adverse event types. CONCLUSION This study represents one of the largest assessments of electrocautery use in patients undergoing CIED revision, upgrade, or replacement procedures. Compared to standard electrocautery, low-temperature electrocautery significantly reduces adverse effects from these procedures.",2021,"In comparison to standard electrocautery, low-temperature electrocautery was associated with a 23% reduction in the incidence of a procedure or lead-related adverse event through 3 years of follow up (HR: 0.77, 95% CI: 0.65-0.91; P = 0.002).","['patients enrolled in the WRAP-IT trial undergoing cardiac implantable electronic device (CIED) revision, upgrade, or replacement', 'patients undergoing CIED revision, upgrade, replacement procedures', '5205 (92.3%) patients (mean [±SD] age: 70.6 ± 12.7 years; 28.8% female); low-temperature electrocautery was used in 1866 (35.9%) patients', '5641 patients underwent device revision/upgrade/replacement']","['Low-temperature electrocautery', 'standard electrocautery, or low-temperature electrocautery (PlasmaBlade TM ', 'standard electrocautery, low-temperature electrocautery', 'standard or low-temperature electrocautery']","['adverse effects', 'number of active leads, degree of capsulectomy, and degree of lead dissection, and renal dysfunction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517546', 'cui_str': '12.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0013804', 'cui_str': 'Electrocoagulation'}]","[{'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0013804', 'cui_str': 'Electrocoagulation'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0395522', 'cui_str': 'Capsulectomy of lens'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}]",5641.0,0.0661147,"In comparison to standard electrocautery, low-temperature electrocautery was associated with a 23% reduction in the incidence of a procedure or lead-related adverse event through 3 years of follow up (HR: 0.77, 95% CI: 0.65-0.91; P = 0.002).","[{'ForeName': 'Suneet', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': 'Valley Health System, Ridgewood, New Jersey. Electronic address: MITTSU@Valleyhealth.com.'}, {'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Wilkoff', 'Affiliation': 'Cleveland Clinic, Cleveland Ohio.'}, {'ForeName': 'Jeanne E', 'Initials': 'JE', 'LastName': 'Poole', 'Affiliation': 'University of Washington School of Medicine, Seattle, Washington.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Kennergren', 'Affiliation': 'Sahlgrenska University Hospital, Göteborg, Sweden.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Wright', 'Affiliation': 'Liverpool Heart and Chest Hospital, Liverpool, United Kingdom.'}, {'ForeName': 'Brett J', 'Initials': 'BJ', 'LastName': 'Berman', 'Affiliation': 'Chula Vista Cardiac Center, Chula Vista, California.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Riggio', 'Affiliation': 'Arizona Arrhythmia Consultants, Scottsdale, Arizona.'}, {'ForeName': 'Darius P', 'Initials': 'DP', 'LastName': 'Sholevar', 'Affiliation': 'Virtua Health System, Camden, New Jersey.'}, {'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Martinez-Arraras', 'Affiliation': 'Amarrillo Heart Group, Amarillo, Texas.'}, {'ForeName': 'Jean B', 'Initials': 'JB', 'LastName': 'Moubarak', 'Affiliation': 'Hamot Medical Center, Erie, Pennsylvania.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Schaller', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Love', 'Affiliation': 'Maine Medical Center, Portland, Maine.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Pickett', 'Affiliation': 'Saint Thomas Research Institute, LLC Thomas, Nashville, Tennessee.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Philippon', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ), Québec, Canada.'}, {'ForeName': 'Zayd', 'Initials': 'Z', 'LastName': 'Eldadah', 'Affiliation': 'MedStar Heart and Vascular Institute, Washington, DC.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Lande', 'Affiliation': 'Medtronic, Mounds View, Minnesota.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Lexcen', 'Affiliation': 'Medtronic, Mounds View, Minnesota.'}, {'ForeName': 'Reece', 'Initials': 'R', 'LastName': 'Holbrook', 'Affiliation': 'Medtronic, Mounds View, Minnesota.'}, {'ForeName': 'Khaldoun G', 'Initials': 'KG', 'LastName': 'Tarakji', 'Affiliation': 'Cleveland Clinic, Cleveland Ohio.'}]",Heart rhythm,['10.1016/j.hrthm.2021.03.033'] 2949,33780806,Comparative effectiveness of psychotherapy approaches on Death Anxiety in Multiple Sclerosis Patients. A pilot randomized controlled trial.,"BACKGROUND Death anxiety (DA) in chronic diseases has occupied the human mind more than other diseases. Therefore, multiple sclerosis (MS) patients are more prone to DA due to recurrence periods. OBJECTIVE Among the psychological interventions the two approaches of logotherapy (LT) and acceptance and commitment therapy (ACT), They pay more attention and concentration on the subject of suffering. Therefore, the present study aimed to compare the effectiveness of these two approaches on DA in MS patients. METHODS The statistical population included 48 women who were diagnosed as MS patients and had medical records at Iran MS Society in Tehran, in terms of entry and exit criteria, which were selected by convenience sampling. Then they were randomly divided into two experimental groups and one control group. This plan has an independent variable at three levels including: LT, ACT and the control group. The dependent variables are the subjects' scores on the Death Attitude Profile-Revised (DAP-R) (Wong., Reker & Gesser, 1994). Therapeutic interventions included 12 sessions of 2 h per week. A 3-hour workshop was held for the control group. in which patients were provided with basic information about the psychological problems of MS, but no strategy was presented. In order to obtain the results, the analysis of covariance was used and in the follow-up study, repeated measures analysis of variance with an intergroup variable (mixed model) was used. RESULTS It showed that both LT and ACT groups were able to be effective and reduce DA in comparison with the control group and such a positive effect on the improvement of DA was evident both in the post-test and follow-up stages. However, no significant differences were observed in comparing the effectiveness of the two intervention methods, so both methods were effective in reducing DA due to the nature of suffering. CONCLUSION Considering the effectiveness of LT and ACT in reducing DA in MS patients, the results of this study can be used in order to achieve therapeutic goals and reduce psychological problems in chronic diseases.",2021,"However, no significant differences were observed in comparing the effectiveness of the two intervention methods, so both methods were effective in reducing DA due to the nature of suffering. ","['MS patients', 'Multiple Sclerosis Patients', '48 women who were diagnosed as MS patients and had medical records at Iran MS Society in Tehran, in terms of entry and exit criteria, which were selected by convenience sampling']","['psychological interventions', 'LT and ACT', 'logotherapy (LT) and acceptance and commitment therapy (ACT', 'psychotherapy approaches']","['Death Attitude Profile-Revised (DAP-R', 'improvement of DA', 'Death Anxiety']","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0337094', 'cui_str': 'Exit'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0204524', 'cui_str': 'Logotherapy'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0004274', 'cui_str': 'Attitudes to Death'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0522179', 'cui_str': 'Death anxiety'}]",48.0,0.011106,"However, no significant differences were observed in comparing the effectiveness of the two intervention methods, so both methods were effective in reducing DA due to the nature of suffering. ","[{'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Lotfifar', 'Affiliation': 'Department of Psychology, Boroujerd Branch, Islamic Azad University, Boroujerd, Iran.'}, {'ForeName': 'Ezatolah', 'Initials': 'E', 'LastName': 'Ghadampour', 'Affiliation': 'Department of Psychology, Faculty of Literature and Humanities, Lorestan University, Khorramabad, Iran. Electronic address: Ghadampour.e@lu.ac.ir.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Bagheri', 'Affiliation': 'Department of Psychology, Faculty of Psychology and Educational Sciences, Roudehen Azad University, Tehran, Iran.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2021.102914'] 2950,33780749,Reinforcing adherence to lipid-lowering therapy after an acute coronary syndrome: A pragmatic randomized controlled trial.,"BACKGROUND AND AIMS Achieving the low-density lipoprotein cholesterol (LDL-C) goal following an acute coronary syndrome (ACS) is a milestone often missed due to suboptimal adherence to secondary prevention treatments. Whether improved adherence could result in reduced LDL-C levels is unclear. We aimed to evaluate whether an educational-motivational intervention increases long-term lipid-lowering therapy (LLT) adherence and LDL-C goal attainment rate among post-ACS patients. METHODS IDEAL-LDL was a parallel, two-arm, single-center, pragmatic, investigator-initiated randomized controlled trial. Hospitalized patients for ACS were randomized to a physician-led integrated intervention consisting of an educational session at baseline, followed by regular motivational interviewing phone sessions or usual care. Co-primary outcomes were the LLT adherence (measured by Proportion of Days Covered (PDC); good adherence defined as PDC>80%), and LDL-C goal (<70 mg/dl or 50% reduction from baseline) achievement rate at one year. RESULTS In total, 360 patients (mean age 62 years, 81% male) were randomized. Overall, good adherence was positively associated with LDL-C goal achievement rate at one year. Median PDC was higher in the intervention group than the control group [0.92 (IQR, 0.82-1.00) vs. 0.86 (0.62-0.98); p = 0.03] while the intervention group had increased odds of good adherence (odds ratio: 1.76 (95% confidence interval 1.02 to 2.62; p = 0.04). However, neither the LDL-C goal achievement rate (49.6% in the intervention vs. 44.9% in the control group; p = 0.49) nor clinical outcomes differed significantly between the two groups. CONCLUSIONS Α multifaceted intervention improved LLT adherence in post-ACS patients without a significant difference in LDL-C goal attainment.",2021,"CONCLUSIONS Α multifaceted intervention improved LLT adherence in post-ACS patients without a significant difference in LDL-C goal attainment.","['acute coronary syndrome (ACS', 'post-ACS patients', '360 patients (mean age 62 years, 81% male', 'Hospitalized patients for ACS', 'acute coronary syndrome']","['lipid-lowering therapy', 'educational-motivational intervention', 'physician-led integrated intervention consisting of an educational session at baseline, followed by regular motivational interviewing phone sessions or usual care']","['Median PDC', 'LLT adherence (measured by Proportion of Days Covered (PDC); good adherence defined as PDC>80%), and LDL-C goal', 'LDL-C goal attainment', 'good adherence', 'LDL-C goal achievement rate', 'clinical outcomes', 'LLT adherence', 'long-term lipid-lowering therapy (LLT) adherence and LDL-C goal attainment rate']","[{'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]","[{'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1739685', 'cui_str': 'PDC protein, human'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",360.0,0.116138,"CONCLUSIONS Α multifaceted intervention improved LLT adherence in post-ACS patients without a significant difference in LDL-C goal attainment.","[{'ForeName': 'Stefanos', 'Initials': 'S', 'LastName': 'Zafeiropoulos', 'Affiliation': '1st Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece; Elmezzi Graduate School of Molecular Medicine and Feinstein Institutes for Medical Research at Northwell Health, Manhasset, NY, USA.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Farmakis', 'Affiliation': '1st Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Anastasios', 'Initials': 'A', 'LastName': 'Kartas', 'Affiliation': '1st Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Arvanitaki', 'Affiliation': '1st Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece; Department of Cardiology III - Adult Congenital and Valvular Heart Disease, University Hospital Muenster, Albert-Schweitzer-Campus 1, Muenster, Germany.'}, {'ForeName': 'Areti', 'Initials': 'A', 'LastName': 'Pagiantza', 'Affiliation': '1st Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece; Department of Internal Medicine, Serres General Hospital, Serres, Greece.'}, {'ForeName': 'Aristi', 'Initials': 'A', 'LastName': 'Boulmpou', 'Affiliation': '3rd Department of Cardiology, Ippokrateion University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Athina', 'Initials': 'A', 'LastName': 'Tampaki', 'Affiliation': '1st Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Diamantis', 'Initials': 'D', 'LastName': 'Kosmidis', 'Affiliation': '1st Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Vassileios', 'Initials': 'V', 'LastName': 'Nevras', 'Affiliation': '1st Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Eleftherios', 'Initials': 'E', 'LastName': 'Markidis', 'Affiliation': '1st Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Papadimitriou', 'Affiliation': '1st Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Vlachou', 'Affiliation': '1st Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Arvanitakis', 'Affiliation': 'Laboratory of Biomathematics, University of Thessaly, School of Medicine, Papakyriazi 22, Building ""Katsigra"", Larissa, Greece.'}, {'ForeName': 'Santiago J', 'Initials': 'SJ', 'LastName': 'Miyara', 'Affiliation': 'Elmezzi Graduate School of Molecular Medicine and Feinstein Institutes for Medical Research at Northwell Health, Manhasset, NY, USA.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Ziakas', 'Affiliation': '1st Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Ernesto P', 'Initials': 'EP', 'LastName': 'Molmenti', 'Affiliation': 'Department of Surgery, North Shore University Hospital, Manhasset, NY, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Kassimis', 'Affiliation': '2nd Department of Cardiology, Ippokrateion University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Zanos', 'Affiliation': 'Institute of Bioelectronic Medicine, Feinstein Institutes for Medical Research, Manhasset, NY, USA.'}, {'ForeName': 'Haralambos', 'Initials': 'H', 'LastName': 'Karvounis', 'Affiliation': '1st Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Giannakoulas', 'Affiliation': '1st Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece. Electronic address: ggiannnakoulas@auth.gr.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2021.03.013'] 2951,33787415,"Long-Term Effect of Receiving a Family Strengths-Oriented Intervention on Family Cancer Caregiver Stress, Anxiety, and Depression Symptoms: A Longitudinal Quasi-Experimental Study.","The aim of this longitudinal study was to evaluate the long-term effects of providing a therapeutic conversation intervention, based on Family Systems Nursing, to family caregivers of a close relative with advanced cancer over the period before and during bereavement. To prevent adverse outcomes, caregivers need ongoing support that begins pre-loss and extends into the post-loss period. This study employed a one-group pre-test, post-test quasi-experimental design. Twenty-four caregivers participated in two intervention trials conducted over a 42-month period, receiving two intervention sessions pre-loss (Trial 1) and one intervention session post-loss (Trial 2). Significant decreases in anxiety and stress were noted over the three post-loss assessments. The final post-loss stress outcome was significantly lower than the first pre-loss score. For the depression score, there was not a significant change over time within the pre- or post-loss period. The findings provide evidence of decreasing anxiety and stress following the implementation of an extended family nursing intervention for bereaved family caregivers.",2021,The findings provide evidence of decreasing anxiety and stress following the implementation of an extended family nursing intervention for bereaved family caregivers.,[],"['Receiving a Family Strengths-Oriented Intervention', 'therapeutic conversation intervention']","['Family Cancer Caregiver Stress, Anxiety, and Depression Symptoms', 'anxiety and stress']",[],"[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1998980', 'cui_str': 'Caregiver role strain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",24.0,0.0254958,The findings provide evidence of decreasing anxiety and stress following the implementation of an extended family nursing intervention for bereaved family caregivers.,"[{'ForeName': 'Asta B', 'Initials': 'AB', 'LastName': 'Petursdottir', 'Affiliation': 'School of Health Sciences, Faculty of Nursing, University of Iceland, Reykjavík, Iceland.'}, {'ForeName': 'Mary Kay', 'Initials': 'MK', 'LastName': 'Rayens', 'Affiliation': 'University of Kentucky, Lexington, USA.'}, {'ForeName': 'Valgerdur', 'Initials': 'V', 'LastName': 'Sigurdardottir', 'Affiliation': 'Landspitali The National University Hospital, Reykjavík, Iceland.'}, {'ForeName': 'Erla Kolbrun', 'Initials': 'EK', 'LastName': 'Svavarsdottir', 'Affiliation': 'School of Health Sciences, Faculty of Nursing, University of Iceland, Reykjavík, Iceland.'}]",Journal of family nursing,['10.1177/1074840721994332'] 2952,33788052,Efficacy and safety of human soluble thrombomodulin (ART-123) for treatment of patients in France with sepsis-associated coagulopathy: post hoc analysis of SCARLET.,"BACKGROUND The phase 3 multinational SCARLET study evaluated the efficacy and safety of a recombinant human soluble thrombomodulin (ART-123) for treatment of sepsis-associated coagulopathy (SAC), which correlates with increased mortality risk in patients with sepsis. Although no significant reduction in mortality was observed with ART-123 compared with placebo in the full analysis set (FAS), an efficacy signal of ART-123 was observed in subgroups of patients who sustained coagulopathy until the first treatment and those not administered concomitant heparin. Post hoc analysis was performed of patients treated in France, the country with the largest enrollment (19% of the FAS) and consistent patient enrollment throughout the study duration. METHODS Adult patients with SAC (international normalized ratio > 1.4; platelets > 30 × 10 9 /L to < 150 × 10 9 /L or platelet decrease > 30% within 24 h) and evidence of bacterial infection were included. The primary efficacy outcome was 28-day all-cause mortality. Safety outcomes included adverse, serious adverse, and major bleeding events. This analysis assessed patient characteristics and efficacy and safety outcomes in France compared with the rest of the world (ROW; excluding France). Mortality rates were assessed in patients in France or the ROW with characteristics previously associated with ART-123 efficacy. RESULTS Baseline characteristics were similar between France and the ROW, but some measurements of disease severity were higher in patients in France. The 28-day all-cause mortality absolute risk reductions (ARRs) with ART-123 were 8.3% in France and 1.1% in the ROW. The greater ARR in France may be related to a higher rate of sustained coagulopathy and lower rate of heparin use. In France and the ROW, 84.6% and 78.0% of patients sustained coagulopathy from the time of initial SAC diagnosis to first treatment with the study drug, and 65.8% and 43.9% did not receive heparin, respectively. The ARRs for these subgroups of patients in France were 13.4% and 16.6%, respectively. Safety of ART-123 was comparable between France and the ROW. CONCLUSIONS Results from this exploratory analysis suggest that patients with sustained SAC not receiving concomitant heparin may benefit from ART-123, a fact that should be confirmed in future studies with more restrictive inclusion criteria.",2021,"Although no significant reduction in mortality was observed with ART-123 compared with placebo in the full analysis set (FAS), an efficacy signal of ART-123 was observed in subgroups of patients who sustained coagulopathy until the first treatment and those not administered concomitant heparin.","['patients with sustained SAC not receiving concomitant', 'Adult patients with SAC (international normalized ratio >\u20091.4; platelets >\u200930\u2009×\u200910 9 /L to <\u2009150\u2009×\u200910 9 /L or platelet decrease >\u200930% within 24\xa0h) and evidence of bacterial infection were included', 'patients in France with sepsis-associated coagulopathy', 'patients with sepsis']","['human soluble thrombomodulin (ART-123', 'heparin', 'placebo', 'recombinant human soluble thrombomodulin (ART-123']","['adverse, serious adverse, and major bleeding events', 'mortality', 'Mortality rates', 'efficacy signal of ART-123', '28-day all-cause mortality', 'Safety of ART-123', 'Efficacy and safety', 'disease severity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0392386', 'cui_str': 'Platelet count below reference range'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0004623', 'cui_str': 'Bacterial infectious disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C1174887', 'cui_str': 'ART123'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C1174887', 'cui_str': 'ART123'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.142147,"Although no significant reduction in mortality was observed with ART-123 compared with placebo in the full analysis set (FAS), an efficacy signal of ART-123 was observed in subgroups of patients who sustained coagulopathy until the first treatment and those not administered concomitant heparin.","[{'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'François', 'Affiliation': 'ICU Department, Inserm CIC-1435 & UMR-1092, CRICS-TRIGGERSEP, CHU Dupuytren, 2 Av Martin Luther King, 87042, Limoges, France. bruno.francois@chu-limoges.fr.'}, {'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Fiancette', 'Affiliation': 'Service de Médecine Intensive Réanimation, Centre Hospitalier Départemental Vendée, La Roche-sur-Yon, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Helms', 'Affiliation': 'Faculté de Médecine, Hôpitaux universitaires de Strasbourg, Service de Médecine Intensive - Réanimation, Nouvel Hôpital Civil, Université de Strasbourg (UNISTRA), Strasbourg, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Mercier', 'Affiliation': 'Médecine Intensive Réanimation, CRICS-TRIGGERSEP, CHRU de Tours, Tours, France.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Lascarrou', 'Affiliation': 'Service de Médecine Intensive Réanimation, Centre Hospitalier Universitaire de Nantes, Nantes, France.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Kayanoki', 'Affiliation': 'Department of Program Management & Scientific Affairs, Asahi Kasei Pharma America Corporation, Waltham, MA, USA.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Department of Program Management & Scientific Affairs, Asahi Kasei Pharma America Corporation, Waltham, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fineberg', 'Affiliation': 'Department of Medical Affairs, Asahi Kasei Pharma America Corporation, Waltham, MA, USA.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Vincent', 'Affiliation': 'Department of Intensive Care, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Wittebole', 'Affiliation': 'Department of Critical Care Medicine, Clinique Universitaire St Luc, UCLouvain, Brussels, Belgium.'}]",Annals of intensive care,['10.1186/s13613-021-00842-4'] 2953,33788040,The role of analytical reasoning and source credibility on the evaluation of real and fake full-length news articles.,"AIM Previous research has focused on accuracy associated with real and fake news presented in the form of news headlines only, which does not capture the rich context news is frequently encountered in real life. Additionally, while previous studies on evaluation of real and fake news have mostly focused on characteristics of the evaluator (i.e., analytical reasoning), characteristics of the news stimuli (i.e., news source credibility) and the interplay between the two have been largely ignored. To address these research gaps, this project examined the role of analytical reasoning and news source credibility on evaluation of real and fake full-length news story articles. The project considered both accuracy and perceived credibility ratings as outcome variables, thus qualifying previous work focused solely on news detection accuracy. METHOD We conducted two independent but parallel studies, with Study 2 as a direct replication of Study 1, employing the same design but in a larger sample (Study 1: N = 292 vs. Study 2: N = 357). In both studies, participants viewed 12 full-length news articles (6 real, 6 fake), followed by prompts to evaluate each article's veracity and credibility. Participants were randomly assigned to view articles with a credible or non-credible source and completed the Cognitive Reflection Test as well as short demographic questions. FINDINGS Consistent across both studies, higher analytical reasoning was associated with greater fake news accuracy, while analytical reasoning was not associated with real news accuracy. In addition, in both studies, higher analytical reasoning was associated with lower perceived credibility for fake news, while analytical reasoning was not associated with perceived credibility for real news. Furthermore, lower analytical reasoning was associated with greater accuracy for real (but not fake) news from credible compared to non-credible sources, with this effect only detected in Study 2. CONCLUSIONS The novel results generated in this research are discussed in light of classical vs. naturalistic accounts of decision-making as well as cognitive processes underlying news articles evaluation. The results extend previous findings that analytical reasoning contributes to fake news detection to full-length news articles. Furthermore, news-related cues such as the credibility of the news source systematically affected discrimination ability between real and fake news.",2021,"FINDINGS Consistent across both studies, higher analytical reasoning was associated with greater fake news accuracy, while analytical reasoning was not associated with real news accuracy.",['larger sample (Study 1: N\u2009=\u2009292 vs. Study 2: N\u2009=\u2009357'],['credible or non-credible source and completed the Cognitive Reflection Test'],[],"[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",[],12.0,0.0647277,"FINDINGS Consistent across both studies, higher analytical reasoning was associated with greater fake news accuracy, while analytical reasoning was not associated with real news accuracy.","[{'ForeName': 'Didem', 'Initials': 'D', 'LastName': 'Pehlivanoglu', 'Affiliation': 'Department of Psychology, University of Florida, 945 Center Dr, Gainesville, FL, 32603, USA. dpehlivanoglu@ufl.edu.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': 'Department of Psychology, University of Florida, 945 Center Dr, Gainesville, FL, 32603, USA.'}, {'ForeName': 'Farha', 'Initials': 'F', 'LastName': 'Deceus', 'Affiliation': 'Department of Psychology, University of Florida, 945 Center Dr, Gainesville, FL, 32603, USA.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Heemskerk', 'Affiliation': 'Department of Psychology, University of Florida, 945 Center Dr, Gainesville, FL, 32603, USA.'}, {'ForeName': 'Natalie C', 'Initials': 'NC', 'LastName': 'Ebner', 'Affiliation': 'Department of Psychology, University of Florida, 945 Center Dr, Gainesville, FL, 32603, USA.'}, {'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Cahill', 'Affiliation': 'Department of Psychology, University of Florida, 945 Center Dr, Gainesville, FL, 32603, USA.'}]",Cognitive research: principles and implications,['10.1186/s41235-021-00292-3'] 2954,33787645,"Improvement of Shen'ge formula on heart function in diastolic heart failure: A protocol for randomized, double-blind, placebo-controlled clinical study.","INTRODUCTION Diastolic heart failure (DHF) is an important pathological type of heart failure, that involves multiple organ dysfunction and multiple complications. The prevalence of DHF is high, and effective treatments are lacking. Chinese herbs are an alternative therapy for DHF. Shen'ge formula (SGF) is a classical formula from which patients can benefit, but convincing evidence of its efficacy is lacking. Therefore, we designed this randomized controlled trial protocol. METHODS/DESIGN This randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of SGF in the treatment of DHF. A total of 130 patients with DHF will be enrolled in the trial and treated with SGF granules or placebo for 12 weeks and followed up for 12 weeks. The primary outcome measurement will be to changes in plasma N-terminal brain natriuretic peptide precursor before versus after treatment, while the second primary outcome measurement will be changes in heart function before versus after treatment and the 12-week follow-up period. It will also include echocardiography, a cardiopulmonary exercise test, cardiac function grading, traditional Chinese medicine syndrome score, and the Minnesota Heart Failure Quality of Life Scale. Adverse events will be evaluated throughout the trial. DISCUSSION The results of this trial will demonstrate whether SGF could alleviate symptoms, improve cardiac function, reduce readmission rates, and improve quality of life of patients with DHF. TRIAL REGISTRATION Chinese Clinical Trial Register, ChiCTR2000036533, registered on August 24, 2020.",2021,"Shen'ge formula (SGF) is a classical formula from which patients can benefit, but convincing evidence of its efficacy is lacking.","['130 patients with DHF', 'diastolic heart failure']","[""Shen'ge formula (SGF"", 'placebo', 'SGF', 'Chinese herbs', 'SGF granules or placebo']","['quality of life', 'Adverse events', 'heart function', 'cardiac function, reduce readmission rates', 'changes in plasma N-terminal brain natriuretic peptide precursor']","[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1135196', 'cui_str': 'Diastolic heart failure'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0019240', 'cui_str': 'Herb'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}]",130.0,0.62749,"Shen'ge formula (SGF) is a classical formula from which patients can benefit, but convincing evidence of its efficacy is lacking.","[{'ForeName': 'Boyong', 'Initials': 'B', 'LastName': 'Qiu', 'Affiliation': 'Department of cardiology, Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine. Shanghai, PR China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': ''}, {'ForeName': 'Siyu', 'Initials': 'S', 'LastName': 'Qiao', 'Affiliation': ''}, {'ForeName': 'Guanghao', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Deng', 'Affiliation': ''}, {'ForeName': 'Duan', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Yihong', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000025383'] 2955,33255579,Effects of Labelling and Increasing the Proportion of Lower-Energy Density Products on Online Food Shopping: A Randomised Control Trial in High- and Low-Socioeconomic Position Participants.,"Reducing the energy density (ED) of product selections made during online supermarket food shopping has potential to decrease energy intake. Yet it is unclear which types of intervention are likely to be most effective and equitable. We recruited 899 UK adults of lower and higher socioeconomic position (SEP) who completed a shopping task in an online experimental supermarket. Participants were randomised in a 2 × 2 between-subjects design to test the effects of two interventions on the ED of shopping basket selections: labelling lower-ED products as healthier choices and increasing the relative availability of lower-ED products within a range (referred to as proportion). Labelling of lower-ED products resulted in a small but significant decrease (-4.2 kcal/100 g, 95% CIs -7.8 to -0.6) in the ED of the shopping basket. Increasing the proportion of lower-ED products significantly decreased the ED of the shopping basket (-17 kcal/100 g, 95% CIs -21 to -14). There was no evidence that the effect of either intervention was moderated by SEP. Thus, both types of intervention decreased the ED of foods selected in an online experimental supermarket. There was no evidence that the effectiveness of either intervention differed in people of lower vs. higher SEP.",2020,Reducing the energy density (ED) of product selections made during online supermarket food shopping has potential to decrease energy intake.,"['Online Food Shopping', 'High- and Low-Socioeconomic Position Participants', '899 UK adults of lower and higher socioeconomic position (SEP) who completed a shopping task in an online experimental supermarket']",['ED of shopping basket selections: labelling lower-ED products'],['energy density (ED'],"[{'cui': 'C0557779', 'cui_str': 'Food shop'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0150768', 'cui_str': 'Shopping'}, {'cui': 'C0557778', 'cui_str': 'Supermarket'}]","[{'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0041472', 'cui_str': 'Murine typhus'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0178587', 'cui_str': 'Density'}]",899.0,0.0729249,Reducing the energy density (ED) of product selections made during online supermarket food shopping has potential to decrease energy intake.,"[{'ForeName': 'Lucile', 'Initials': 'L', 'LastName': 'Marty', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, Liverpool L69 7ZA, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Cook', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford OX2 6GG, UK.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Piernas', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford OX2 6GG, UK.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford OX2 6GG, UK.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Robinson', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, Liverpool L69 7ZA, UK.'}]",Nutrients,['10.3390/nu12123618'] 2956,33813930,Differential Effects of Sound Intervention and Rest on Cardiovascular Parameters in Cancer Patients: A Randomized Cross-over Trial.,"BACKGROUND Music therapy or sound interventions were shown to confer beneficial effects in patients with cancer for instance in terms of pain or fear relief and improvement of other patient reported outcomes. Cardiovascular parameters, especially heart rate variability (HRV) were found to have prognostic implications in cancer patients. In this trial we aimed to investigate the effects of a sound intervention on cardiovascular parameters compared to rest in patients with cancer. METHODS AND RESULTS Using a randomized cross-over design, 52 patients (male 13, female 39) with cancer were recruited to receive both a 15-minute sound intervention and a 15-minute rest intervention within 4 weeks with at least a one-week blanking period. Cardiovascular parameters (among others HRV, aortic pulse wave velocity [PWV], augmentation index [Aix], aortic blood pressure [BP], heart rate [HR]) were assessed immediately before (pre) and after (post) the intervention had taken place. HRV (Root mean square of successive RR interval differences [RMSSD, ms]) significantly increased, during sound intervention (median RMSSD pre 24 [range 5-112] vs post 22 [range 9-141], P  = .03). Likewise, median PWV, as a direct marker of arterial stiffness, was significantly reduced by sound intervention ([m/s] pre 8.5 [range 5.6-19.6] vs post 8.3 [range 5.6-15.6], P  = .04). For both parameters no statistically significant change during rest was observed. HR was lowered by both, rest ( P  < .0001) and sound intervention ( P  = .02), with a more pronounced effect by rest. A significant increase in systolic aortic blood pressure was shown by rest ([mmHg] median 101 [range 78-150] vs post median 103 [range 71-152], P  = .04) but not during sound intervention ( P  = .59), while rest intervention led to a decrease in resistance index (pre median 33 [range 13-92] vs post median 32 [11-84], P  = .02). CONCLUSION In comparison with rest, a single sound intervention in patients with cancer improved cardiovascular parameters commonly associated with increased stress levels. Studies with longer follow-up and multiple interventions are warranted. TRIAL REGISTRATION ISRCTN registry 70947363.",2021,"HR was lowered by both, rest ( P  < .0001) and sound intervention ( P  = .02), with a more pronounced effect by rest.","['52 patients (male 13, female 39) with cancer', 'patients with cancer', 'Cancer Patients', 'cancer patients']","['Sound Intervention and Rest', 'sound intervention']","['cardiovascular parameters', 'aortic pulse wave velocity [PWV], augmentation index [Aix], aortic blood pressure [BP], heart rate [HR', 'Cardiovascular parameters', 'HR', 'Likewise, median PWV, as a direct marker of arterial stiffness', 'heart rate variability (HRV', 'Cardiovascular Parameters', 'systolic aortic blood pressure', 'resistance index', 'stress levels', 'HRV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456180', 'cui_str': 'Aortic pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]",,0.0407914,"HR was lowered by both, rest ( P  < .0001) and sound intervention ( P  = .02), with a more pronounced effect by rest.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hohneck', 'Affiliation': 'University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Reyser', 'Affiliation': 'University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Merx', 'Affiliation': 'University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Weingärtner', 'Affiliation': 'University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Mavratzas', 'Affiliation': 'University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Schumacher', 'Affiliation': 'inmediQ GmbH, Butzbach, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Linhuber', 'Affiliation': 'Klangkoerper.de, Heidelberg, Germany.'}, {'ForeName': 'Wolf-Karsten', 'Initials': 'WK', 'LastName': 'Hofmann', 'Affiliation': 'University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Burkholder', 'Affiliation': 'University of Applied Sciences of the Saarland, Saarbrucken, Germany.'}, {'ForeName': 'Ralf-Dieter', 'Initials': 'RD', 'LastName': 'Hofheinz', 'Affiliation': 'University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}]",Integrative cancer therapies,['10.1177/1534735421995239'] 2957,33780940,Early Coaching to Increase Water Intake in CKD.,"INTRODUCTION In observational studies, increased water intake improves kidney function but not in adults with CKD stage 3 and more. CKD WIT trial has shown a nonsignificant gradual decline in kidney function after 1 year of coaching to increase water intake (CIWI) [1]. We propose that CIWI may benefit in CKD stage 1-2 (G1 and G2) and depends on functional renal functional reserve (RFR) [2, 3]. OBJECTIVE Parallel-group randomized trial was aimed to determinate the effectiveness of CIWI dependence of estimated glomerular filtration rate (eGFR) stage and RFR in adults with CKD 1-2 stages. METHODS CKD WIT trial was taken as the basis for prospective multicenter randomized trial named ""Early Coaching to Increase Water Intake in CKD (ECIWIC)."" The primary outcome was the change in kidney function by eGFR from baseline to 12 months. Secondary outcomes included 1-year change in urine albumin/Cr ratio, and patient-reported overall quality of health (QH) ranged from 0 (worst possible) to 10 (best possible). CIWI aimed to have the diuresis being 1.7-2 L. There were 4 groups with nondiet sodium restriction which consisted of 31 patients each: 2 groups with CKD G1 and CKD G2, undergoing CIWI and 2 others with CKD G1 and CKD G2 without CIWI (Fig. 1a). Overall checks were made at 0, 6, and 12 months. RFR evaluation was performed using 0.45% sodium chloride oral solution. RESULTS Of our randomized 124 patients (mean age 53.2 years; men 83 [67%], 0 died), mean change in 24-h urine volume was 0.6 L per day in G1 with CIWI group and 0.5 L in G2. No statistically significant data on eGFR depending CIWI were obtained (Fig. 1b). However, the trend suggests that CIWI improves eGFR in CKD G1 (from 95 to 96 mL/min/1.73 m2) and preserves eGFR decline in CKD G2 (78-78). The QH values were also preserved (from 7 to 7 in G1 and G2 groups). Although coaching to maintain the same water intake did not preserve physiological and pathological eGFR decreasing in CKD G1-2 (G1 from 96 to 93, G2 from 76 to 73; t = 0.6, p = 0.29, and p ≤ 0.05 in all groups) and the QH was declined (from 7 to 6 in both groups). An individual analysis of the RFR has shown that patients with RFR more than 50% (G1 19 patients, 61%, and G2 13 patients, 42%) had reliable preservation of eGFR with its increase of 1.5 mL/min on CIWI, while patients with low functional renal reserve had a drop of eGFR at 1.1 mL/min/m2 within 12 months. Patients with low normal serum sodium levels have shown worse results on CIWI. CONCLUSIONS With CKD G1, the CIWI leads to the preservation of the renal function with its increase of GFR per 1 mL/min/m2/per year in comparison with the same water intake. In CKD G2, the CIWI prevents physiological and pathological loss of renal function, and RFR above 50% aids restoration of eGFR both in CKD G1-2. ECIWIC trial demonstrates benefit of CIWI in patients with CKD 1-2 and preserved RFR.",2020,"Although coaching to maintain the same water intake did not preserve physiological and pathological eGFR decreasing in CKD G1-2 (G1 from 96 to 93, G2 from 76 to 73; t = 0.6, p = 0.29, and p ≤ 0.05 in all groups) and the QH was declined (from 7 to 6 in both groups).","['patients with CKD 1-2 and preserved RFR', 'adults with CKD stage 3 and more', '124 patients (mean age 53.2 years; men 83 [67%], 0 died', 'adults with CKD 1-2 stages']","['CKD G1', 'sodium chloride oral solution']","['Overall checks', 'reliable preservation of eGFR', 'functional renal functional reserve (RFR', 'physiological and pathological eGFR', 'kidney function', 'QH values', 'mean change in 24-h urine volume', 'QH', 'physiological and pathological loss of renal function, and RFR', 'change in kidney function by eGFR', '1-year change in urine albumin/Cr ratio, and patient-reported overall quality of health (QH', 'glomerular filtration rate (eGFR) stage and RFR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2316787', 'cui_str': 'Chronic kidney disease stage 3'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0991536', 'cui_str': 'Oral solution'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042038', 'cui_str': 'Albumin urine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",124.0,0.0297303,"Although coaching to maintain the same water intake did not preserve physiological and pathological eGFR decreasing in CKD G1-2 (G1 from 96 to 93, G2 from 76 to 73; t = 0.6, p = 0.29, and p ≤ 0.05 in all groups) and the QH was declined (from 7 to 6 in both groups).","[{'ForeName': 'Mariia D', 'Initials': 'MD', 'LastName': 'Ivanova', 'Affiliation': 'Milano-Bicocca University, Milan, Italy.'}, {'ForeName': 'Anatoliy I', 'Initials': 'AI', 'LastName': 'Gozhenko', 'Affiliation': 'Ukrainian Scientific Research Institute of Transport, Odesa, Ukraine.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Crestanello', 'Affiliation': 'Shupyk National Medical Academy of Postgraduate Education, Kiev, Ukraine.'}, {'ForeName': 'Dmytro D', 'Initials': 'DD', 'LastName': 'Ivanov', 'Affiliation': 'Shupyk National Medical Academy of Postgraduate Education, Kiev, Ukraine.'}]",Annals of nutrition & metabolism,['10.1159/000515276'] 2958,33780930,Effects of a 14-Day Hydration Intervention on Individuals with Habitually Low Fluid Intake.,"BACKGROUND Debate continues over whether or not individuals with low total water intake (TWI) are in a chronic fluid deficit (i.e., low total body water) [1]. When women with habitually low TWI (1.6 ± 0.5 L/day) increased their fluid intake (3.5 ± 0.1 L/day) for 4 days 24-h urine osmolality decreased, but there was no change in body weight, a proxy for total body water (TBW) [2]. In a small (n = 5) study of adult men, there were no observable changes in TBW, as measured by bioelectrical impedance, after increasing TWI for 4 weeks [3]. However, body weight increased and salivary osmolality decreased indicating that the study may have been underpowered to detect changes in TBW. Further, no studies to date have measured changes in blood volume (BV) when TWI is increased. OBJECTIVES Therefore, the purpose of this study was to identify individuals with habitually low fluid intake and determine if increasing TWI, for 14 days, resulted in changes in TBW or BV. METHODS In order to identify individuals with low TWI, 889 healthy adults were screened. Participants with a self-reported TWI less than 1.8 L/day (men) or 1.2 L/day (women), and a 24-h urine osmolality greater than 800 mOsm were included in the intervention phase of the study. For the intervention phase, 15 participants were assigned to the experimental group and 8 participants were assigned to the control group. The intervention period lasted for 14 days and consisted of 2 visits to our laboratory: one before the intervention (baseline) and 14 days into the intervention (14-day follow-up). At these visits, BV was measured using a CO-rebreathe procedure and deuterium oxide (D2O) was administered to measure TBW. Urine samples were collected immediately prior, and 3-8 h after the D2O dose to allow for equilibration. Prior to each visit, participants collected 24-h urine to measure 24-h hydration status. After the baseline visit, the experimental group increased their TWI to 3.7 L for males and 2.7 L for females in order to meet the current Institute of Medicine recommendations for TWI. RESULTS Twenty-four-hour urine osmolality decreased (-438.7 ± 362.1 mOsm; p < 0.001) and urine volume increased (1,526 ± 869 mL; p < 0.001) in the experimental group from baseline, while there were no differences in osmolality (-74.7 ± 572 mOsm; p = 0.45), or urine volume (-32 ± 1,376 mL; p = 0.89) in the control group. However, there were no changes in BV (Fig. 1a) or changes in TBW (Fig. 1b) in either group. CONCLUSIONS Increasing fluid intake in individuals with habitually low TWI increases 24-h urine volume and decreases urine osmolality but does not result in changes in TBW or BV. These findings are in agreement with previous work indicating that TWI interventions lasting 3 days [2] to 4 weeks [3] do not result in changes in TBW. Current evidence would suggest that the benefits of increasing TWI are not related changes in TBW.",2020,"RESULTS Twenty-four-hour urine osmolality decreased (-438.7 ± 362.1 mOsm; p < 0.001) and urine volume increased (1,526 ± 869 mL; p < 0.001) in the experimental group from baseline, while there were no differences in osmolality (-74.7 ± 572 mOsm; p = 0.45), or urine volume (-32 ± 1,376 mL; p = 0.89) in the control group.","['individuals with low TWI, 889 healthy adults were screened', 'Individuals with Habitually Low Fluid Intake', 'Participants with a self-reported TWI less than 1.8 L/day (men) or 1.2 L/day (women), and a 24-h urine osmolality greater than 800 mOsm were included in the intervention phase of the study']",['14-Day Hydration Intervention'],"['urine volume', 'fluid intake', 'salivary osmolality', 'osmolality', 'blood volume (BV', 'body weight, a proxy for total body water (TBW) ', 'urine osmolality']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013123', 'cui_str': 'Water intake'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0429791', 'cui_str': 'Fluid intake'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0475219', 'cui_str': 'L/day'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0740085', 'cui_str': 'Osmolality measurement, urine'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0439154', 'cui_str': 'mosmol'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0429791', 'cui_str': 'Fluid intake'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0086741', 'cui_str': 'Osmolality'}, {'cui': 'C0005850', 'cui_str': 'Blood volume'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0412472', 'cui_str': 'Total body water measurement'}, {'cui': 'C0740085', 'cui_str': 'Osmolality measurement, urine'}]",889.0,0.0412971,"RESULTS Twenty-four-hour urine osmolality decreased (-438.7 ± 362.1 mOsm; p < 0.001) and urine volume increased (1,526 ± 869 mL; p < 0.001) in the experimental group from baseline, while there were no differences in osmolality (-74.7 ± 572 mOsm; p = 0.45), or urine volume (-32 ± 1,376 mL; p = 0.89) in the control group.","[{'ForeName': 'Aaron R', 'Initials': 'AR', 'LastName': 'Caldwell', 'Affiliation': 'Exercise Science Research Center, University of Arkansas-Fayetteville, Fayetteville, Arkansas, USA.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Rosa-Caldwell', 'Affiliation': 'Exercise Science Research Center, University of Arkansas-Fayetteville, Fayetteville, Arkansas, USA.'}, {'ForeName': 'Carson', 'Initials': 'C', 'LastName': 'Keeter', 'Affiliation': 'Hydration Physiology Laboratory, University of Wyoming, Laramie, Wyoming, USA.'}, {'ForeName': 'Evan C', 'Initials': 'EC', 'LastName': 'Johnson', 'Affiliation': 'Hydration Physiology Laboratory, University of Wyoming, Laramie, Wyoming, USA.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Péronnet', 'Affiliation': 'QC, Université de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Ganio', 'Affiliation': 'Exercise Science Research Center, University of Arkansas-Fayetteville, Fayetteville, Arkansas, USA.'}]",Annals of nutrition & metabolism,['10.1159/000515375'] 2959,33780928,"The Influence of Fluid Intake Behavior on Cognition and Mood among College Students in Baoding, China.","INTRODUCTION Water is a critical nutrient, and it is important for the maintenance of the physiological function of the human body [1-3]. In addition to fluid amounts, fluid intake frequency is also important for hydration status [4, 5]. At present, only few guidelines mention fluid intake behavior that recommend drinking water frequently while in small quantities, however, there is no scientific evidence to support it. Therefore, it is necessary to explore the appropriate fluid intake behavior. OBJECTIVE The objective of this study is to evaluate the influence of different fluid intake behavior on cognition and mood, to provide scientific basis for proposing the appropriate fluid intake behavior. METHODS A double-blinded randomized controlled trial was designed and implemented among college students aged 18-23 years in Baoding, China. Subjects were randomly assigned into each of 3 groups using a random number generated by computer software: the subjects consuming plain water 200 mL/2 h, that is, 1,600 mL during whole day (group 1), 100 mL/2 h, that is, 800 mL during whole day (group 2), and 110 mL/1 h, that is, 1,650 mL during whole day (group 3), respectively. Subjects were asked to fast from 11:00 p.m., without consuming any foods or drinks the day before the intervention. From 8:00 a.m. to 10:00 p.m. of the first study day, subjects consumed water according to the instructions and repeated it from 8:00 a.m. to 4:00 p.m. of the second study day. Cognition, mood, and urine osmolality were collected twice at 10:00 a.m. (time 1) and 4:00 p.m. (time 2) of the second study day (shown in Fig. 1). RESULTS A total of 92 subjects (46 males, 46 females) completed this study. It was found that the increasing fluid intake amounts lead to an increase in urine output and a decrease in urine osmolality (p < 0.05). Use the mixed models to compare measurements for groups 1 and 2, which showed that when compared with those drinking 800 mL per day, people who drank 1,600 mL per day scored higher in vigor (11.8 vs. 9.1, p < 0.05) and portrait memory test (22.6 vs. 20.8, p < 0.05) but lower in total mood disturbance (90.8 vs. 97.8, p < 0.05). By comparing groups 1 and 3, the results indicated that compared with drinking 8 times per day, people who drank 15 times per day scored lower in portrait memory test (21.8 vs. 22.6, p < 0.05) and hunger (3.3 vs. 3.6, p < 0.05). CONCLUSIONS Reasonable fluid intake behavior may be beneficial to improve the cognition and mood of college students. The fluid intake behavior, which is consuming water 200 mL each time and 8 times per day, is recommended. More studies are needed to advise people to have health-beneficial fluid intake behavior.",2020,It was found that the increasing fluid intake amounts lead to an increase in urine output and a decrease in urine osmolality (p < 0.05).,"['college students aged 18-23 years in Baoding, China', 'College Students in Baoding, China', '92 subjects (46 males, 46 females) completed this study']","['random number generated by computer software: the subjects consuming plain water 200 mL/2 h', 'Fluid Intake Behavior']","['hunger', 'urine output', 'Cognition, mood, and urine osmolality', 'portrait memory test', 'total mood disturbance', 'urine osmolality']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0429791', 'cui_str': 'Fluid intake'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0740085', 'cui_str': 'Osmolality measurement, urine'}, {'cui': 'C0376644', 'cui_str': 'Portraits'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2939186', 'cui_str': 'Disturbance in mood'}]",92.0,0.0765252,It was found that the increasing fluid intake amounts lead to an increase in urine output and a decrease in urine osmolality (p < 0.05).,"[{'ForeName': 'Hairong', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Department of Nutrition and Food Hygiene, School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Jian Fen', 'Initials': 'JF', 'LastName': 'Zhang', 'Affiliation': 'Department of Nutrition and Food Hygiene, School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Department of Nutrition and Food Hygiene, School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Songming', 'Initials': 'S', 'LastName': 'Du', 'Affiliation': 'Chinese Nutrition Society, Beijing, China.'}, {'ForeName': 'Shufang', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Health Science Center, Hebei University, Baoding, China.'}, {'ForeName': 'Guansheng', 'Initials': 'G', 'LastName': 'Ma', 'Affiliation': 'Department of Nutrition and Food Hygiene, School of Public Health, Peking University, Beijing, China.'}]",Annals of nutrition & metabolism,['10.1159/000515020'] 2960,33780748,The effect of attachment security priming and oxytocin on physiological responses to trauma films and subsequent intrusions.,"To further understand protective mechanisms to prevent post-traumatic stress disorder or assist recovery from psychological trauma, this study investigated whether pharmacological and psychological activation of a secure attachment representation elicits higher felt-security and a related response pattern of reduced physiological arousal and increased parasympathetic activation; and whether it protects individuals from developing intrusions and experiencing distress in the week following exposure to a trauma film. Using a double-blind, experimental mixed factorial design, 101 volunteers received either oxytocin or placebo and either secure attachment or neutral priming before watching a trauma film. We measured felt security as an indicator of the strength of activation of a secure attachment representation, skin conductance and heart rate as indicators of physiological arousal, and high frequency heart rate variability as an indicator of parasympathetic activation during the priming and the film. Participants then completed a seven-day intrusion diary. Secure attachment priming, but not oxytocin administration or the combination of both, was associated with reduced physiological arousal and increased parasympathetic activity during priming. Although secure attachment priming was not related to the absolute number of intrusions or to less perceived distress or physiological arousal during the trauma film, it was associated with lower intrusion-related distress in the 7-days post-testing. Our findings extend previous research that suggests the importance of interventions that address intrusion-related distress for recovery from trauma, and suggest a promising role for secure attachment priming in trauma-focused psychological therapies. We contribute to the growing literature that finds that higher subjective distress during a trauma is associated with higher intrusion-related distress. We discuss theoretical implications and possible mechanisms through which secure attachment priming may exert potential beneficial effects.",2021,"Although secure attachment priming was not related to the absolute number of intrusions or to less perceived distress or physiological arousal during the trauma film, it was associated with lower intrusion-related distress in the 7-days post-testing.",['101 volunteers received either'],"['oxytocin', 'attachment security priming and oxytocin', 'oxytocin or placebo and either secure attachment or neutral priming before watching a trauma film']",['physiological arousal and increased parasympathetic activity'],"[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0582757', 'cui_str': 'Secure attachment'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C1704608', 'cui_str': 'Film'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",101.0,0.0892772,"Although secure attachment priming was not related to the absolute number of intrusions or to less perceived distress or physiological arousal during the trauma film, it was associated with lower intrusion-related distress in the 7-days post-testing.","[{'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Karl', 'Affiliation': 'Psychology, University of Exeter, Exeter, UK. Electronic address: a.karl@exeter.ac.uk.'}, {'ForeName': 'Katherine B', 'Initials': 'KB', 'LastName': 'Carnelley', 'Affiliation': 'School of Psychology, University of Southampton, Southampton, UK.'}, {'ForeName': 'Gizem', 'Initials': 'G', 'LastName': 'Arikan', 'Affiliation': 'Department of Psychology, Ozyegin University, Istanbul, Turkey.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Baldwin', 'Affiliation': 'Faculty of Medicine, University of Southampton, UK; Department of Psychiatry and Mental Health, University of Cape Town, South Africa.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heinrichs', 'Affiliation': 'Department of Psychology, University of Freiburg, Germany.'}, {'ForeName': 'Lusia', 'Initials': 'L', 'LastName': 'Stopa', 'Affiliation': 'School of Psychology, University of Southampton, Southampton, UK.'}]",Behaviour research and therapy,['10.1016/j.brat.2021.103845'] 2961,33783888,Increased motor variability facilitates motor learning in weight shift toward the paretic side during walking in individuals post-stroke.,"The purpose of this study was to determine whether applying ""varied"" versus constant pelvis assistance force mediolaterally toward the paretic side of stroke survivors during walking would result in short-term improvement in weight shift toward the paretic side. Twelve individuals post-stroke (60.4 ± 6.2 years; gait speed: 0.53 ± 0.19 m/s) were tested under two conditions (varied vs. constant). Each condition was conducted in a single separate session, which consisted of (a) treadmill walking with no assistance force for 1 min (baseline), pelvis assistance toward the paretic side for 9 min (adaptation), and then no force for additional 1 min (post-adaptation), and (b) overground walking. In the ""varied"" condition, the magnitude of force was randomly changed across steps between 30% and 100% of the predetermined amount. In the abrupt condition, the magnitude of force was kept constant at 100% of the predetermined amount. Participants exhibited greater improvements in weight shift toward the paretic side (p < 0.01) and in muscle activity of plantar flexors and hip adductors of the paretic leg (p = 0.02) from baseline to late post-adaptation period for the varied condition than for the constant condition. Motor variability of the peak pelvis displacement at baseline was correlated with improvement in weight shift toward the paretic side after training for the varied (R 2  = 0.64, p = 0.01) and the constant condition (R 2  = 0.39, p = 0.03). These findings suggest that increased motor variability, induced by applying the varied pelvis assistance, may facilitate motor learning in weight shift and gait symmetry during walking in individuals post-stroke.",2021,Participants exhibited greater improvements in weight shift toward the paretic side (P<0.01) and in muscle activity of plantarflexors and hip adductors of the paretic leg (P=0.02) from baseline to late post-adaptation period for the varied condition than for the constant condition.,['Twelve individuals post-stroke (60.4±6.2 yrs; gait speed: 0.53±0.19 m/s) were tested under two conditions (varied vs. constant'],"['varied"" versus constant pelvis assistance force mediolaterally', 'treadmill walking with no assistance force for 1 minute (baseline), pelvis assistance toward the paretic side for 9 minutes (adaptation), and then no force for additional 1 minute (post-adaptation), and 2) overground walking']","['weight shift toward the paretic side (P<0.01) and in muscle activity of plantarflexors and hip adductors of the paretic leg', 'weight shift', 'Motor variability of the peak pelvis displacement']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0439493', 'cui_str': 'm/s'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1720529', 'cui_str': 'Constant'}]","[{'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}]",,0.0412402,Participants exhibited greater improvements in weight shift toward the paretic side (P<0.01) and in muscle activity of plantarflexors and hip adductors of the paretic leg (P=0.02) from baseline to late post-adaptation period for the varied condition than for the constant condition.,"[{'ForeName': 'Seoung Hoon', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Legs and Walking Lab, Shirley Ryan AbilityLab, Chicago, IL, USA.'}, {'ForeName': 'Chao-Jung', 'Initials': 'CJ', 'LastName': 'Hsu', 'Affiliation': 'Legs and Walking Lab, Shirley Ryan AbilityLab, Chicago, IL, USA.'}, {'ForeName': 'Jui-Te', 'Initials': 'JT', 'LastName': 'Lin', 'Affiliation': 'Legs and Walking Lab, Shirley Ryan AbilityLab, Chicago, IL, USA.'}, {'ForeName': 'Weena', 'Initials': 'W', 'LastName': 'Dee', 'Affiliation': 'Legs and Walking Lab, Shirley Ryan AbilityLab, Chicago, IL, USA.'}, {'ForeName': 'Elliot J', 'Initials': 'EJ', 'LastName': 'Roth', 'Affiliation': 'Legs and Walking Lab, Shirley Ryan AbilityLab, Chicago, IL, USA.'}, {'ForeName': 'William Z', 'Initials': 'WZ', 'LastName': 'Rymer', 'Affiliation': 'Legs and Walking Lab, Shirley Ryan AbilityLab, Chicago, IL, USA.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Legs and Walking Lab, Shirley Ryan AbilityLab, Chicago, IL, USA.'}]",The European journal of neuroscience,['10.1111/ejn.15212'] 2962,33781979,Vein of Marshall ethanol infusion in the treatment of atrial fibrillation: From concept to clinical practice.,"The vein of Marshall (VOM) contains innervation, myocardial connections, and arrhythmogenic foci that make it an attractive target in catheter ablation of atrial fibrillation (AF). Additionally, it co-localizes with the mitral isthmus, which is critical to sustain perimitral flutter, and is a true atrial vein that communicates with underlying myocardium. Retrograde balloon cannulation of the VOM from the coronary sinus is feasible and allows for ethanol delivery, which results in rapid ablation of neighboring myocardium and its innervation. Here we review the body of work performed over a span of 13 years, from the inception of the technique, to its preclinical validation, to demonstration of its ablative and denervation effects, and finally to completion of a randomized clinical trial demonstrating favorable outcomes, improving rhythm control in catheter ablation of persistent AF.",2021,"Additionally, it co-localizes with the mitral isthmus, critical to sustain perimitral flutter, and is a true atrial vein that communicates with underlying myocardium.",['catheter ablation of persistent AF'],"['Retrograde balloon cannulation of the VOM', 'Marshall Ethanol Infusion']",[],"[{'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}]","[{'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]",[],,0.0418833,"Additionally, it co-localizes with the mitral isthmus, critical to sustain perimitral flutter, and is a true atrial vein that communicates with underlying myocardium.","[{'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Valderrábano', 'Affiliation': 'Division of Cardiac Electrophysiology, Department of Cardiology, Houston Methodist DeBakey Heart and Vascular Center and Houston Methodist Research Institute, The Methodist Hospital, Houston, Texas. Electronic address: MValderrabano@houstonmethodist.org.'}]",Heart rhythm,['10.1016/j.hrthm.2021.03.032'] 2963,33781913,Safety and immunogenicity of ChAd63-KH vaccine in post-kala-azar dermal leishmaniasis patients in Sudan.,"Post-kala-azar dermal leishmaniasis (PKDL) is a chronic, stigmatizing skin condition occurring frequently after apparent clinical cure from visceral leishmaniasis. Given an urgent need for new treatments, we conducted a phase IIa safety and immunogenicity trial of ChAd63-KH vaccine in Sudanese patients with persistent PKDL. LEISH2a (ClinicalTrials.gov: NCT02894008) was an open-label three-phase clinical trial involving sixteen adult and eight adolescent patients with persistent PKDL (median duration, 30 months; range, 6-180 months). Patients received a single intramuscular vaccination of 1 × 10 10 viral particles (v.p.; adults only) or 7.5 × 10 10 v.p. (adults and adolescents), with primary (safety) and secondary (clinical response and immunogenicity) endpoints evaluated over 42-120 days follow-up. AmBisome was provided to patients with significant remaining disease at their last visit. ChAd63-KH vaccine showed minimal adverse reactions in PKDL patients and induced potent innate and cell-mediated immune responses measured by whole-blood transcriptomics and ELISpot. 7/23 patients (30.4%) monitored to study completion showed >90% clinical improvement, and 5/23 (21.7%) showed partial improvement. A logistic regression model applied to blood transcriptomic data identified immune modules predictive of patients with >90% clinical improvement. A randomized controlled trial to determine whether these clinical responses were vaccine-related and whether ChAd63-KH vaccine has clinical utility is underway.",2021,ChAd63-KH vaccine showed minimal adverse reactions in PKDL patients and induced potent innate and cell-mediated immune responses measured by whole blood transcriptomics and ELISpot.,"['Sudanese patients with persistent PKDL', 'adults and adolescents), with primary (safety) and secondary (clinical response and immunogenicity) endpoints evaluated over 42-120 days follow up', 'sixteen adult and eight adolescent patients with persistent PKDL (median duration 30 months; range 6-180 months', 'post kala azar dermal leishmaniasis patients in Sudan']","['Post kala azar dermal leishmaniasis (PKDL', 'ChAd63-KH vaccine']","['Safety and immunogenicity', 'minimal adverse reactions']","[{'cui': 'C0241297', 'cui_str': 'Sudanese'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0032749', 'cui_str': 'Post-kala-azar dermal leishmaniasis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0038642', 'cui_str': 'Sudan'}]","[{'cui': 'C0032749', 'cui_str': 'Post-kala-azar dermal leishmaniasis'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",16.0,0.108176,ChAd63-KH vaccine showed minimal adverse reactions in PKDL patients and induced potent innate and cell-mediated immune responses measured by whole blood transcriptomics and ELISpot.,"[{'ForeName': 'Brima M', 'Initials': 'BM', 'LastName': 'Younis', 'Affiliation': 'Department of Clinical Pathology & Immunology, Institute of Endemic Diseases, University of Khartoum, Army Ave., Khartoum, Sudan.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Osman', 'Affiliation': 'York Biomedical Research Institute, Hull York Medical School, University of York, Heslington, York YO10 5DD, UK.'}, {'ForeName': 'Eltahir A G', 'Initials': 'EAG', 'LastName': 'Khalil', 'Affiliation': 'Department of Clinical Pathology & Immunology, Institute of Endemic Diseases, University of Khartoum, Army Ave., Khartoum, Sudan.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Santoro', 'Affiliation': 'Department of Medical Biotechnologies, University of Siena, Siena 53100, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Furini', 'Affiliation': 'Department of Medical Biotechnologies, University of Siena, Siena 53100, Italy.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Wiggins', 'Affiliation': 'York Biomedical Research Institute, Hull York Medical School, University of York, Heslington, York YO10 5DD, UK.'}, {'ForeName': 'Ada', 'Initials': 'A', 'LastName': 'Keding', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, York YO10 5DD, UK.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Carraro', 'Affiliation': 'Department of Medical Biotechnologies, University of Siena, Siena 53100, Italy.'}, {'ForeName': 'Anas E A', 'Initials': 'AEA', 'LastName': 'Musa', 'Affiliation': 'Department of Clinical Pathology & Immunology, Institute of Endemic Diseases, University of Khartoum, Army Ave., Khartoum, Sudan.'}, {'ForeName': 'Mujahid A A', 'Initials': 'MAA', 'LastName': 'Abdarahaman', 'Affiliation': 'Department of Clinical Pathology & Immunology, Institute of Endemic Diseases, University of Khartoum, Army Ave., Khartoum, Sudan.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mandefield', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, York YO10 5DD, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bland', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, York YO10 5DD, UK.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Aebischer', 'Affiliation': 'Robert Koch Institute, 13353 Berlin, Germany.'}, {'ForeName': 'Rhian', 'Initials': 'R', 'LastName': 'Gabe', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Queen Mary University of London, London E1 4NS, UK.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Layton', 'Affiliation': 'York Biomedical Research Institute, Hull York Medical School, University of York, Heslington, York YO10 5DD, UK.'}, {'ForeName': 'Charles J N', 'Initials': 'CJN', 'LastName': 'Lacey', 'Affiliation': 'York Biomedical Research Institute, Hull York Medical School, University of York, Heslington, York YO10 5DD, UK.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Kaye', 'Affiliation': 'York Biomedical Research Institute, Hull York Medical School, University of York, Heslington, York YO10 5DD, UK. Electronic address: paul.kaye@york.ac.uk.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Musa', 'Affiliation': 'Department of Clinical Pathology & Immunology, Institute of Endemic Diseases, University of Khartoum, Army Ave., Khartoum, Sudan. Electronic address: musaam2003@yahoo.co.uk.'}]",Molecular therapy : the journal of the American Society of Gene Therapy,['10.1016/j.ymthe.2021.03.020'] 2964,33784735,Effect of Intravitreous Anti-Vascular Endothelial Growth Factor vs Sham Treatment for Prevention of Vision-Threatening Complications of Diabetic Retinopathy: The Protocol W Randomized Clinical Trial.,"Importance The role of anti-vascular endothelial growth factor injections for the management of nonproliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME) has not been clearly established. Objective To determine the efficacy of intravitreous aflibercept injections compared with sham treatment in preventing potentially vision-threatening complications in eyes with moderate to severe NPDR. Design, Setting, and Participants Data for this study were collected between January 15, 2016, and May 28, 2020, from the ongoing DRCR Retina Network Protocol W randomized clinical trial, conducted at 64 US and Canadian sites among 328 adults (399 eyes) with moderate to severe NPDR (Early Treatment Diabetic Retinopathy Study severity level, 43-53), without CI-DME. Analyses followed the intent-to-treat principle. Interventions Eyes were randomly assigned to 2.0 mg of aflibercept injections (n = 200) or sham (n = 199) given at baseline; 1, 2, and 4 months; and every 4 months through 2 years. Between 2 and 4 years, treatment was deferred if the eye had mild NPDR or better. Aflibercept was administered in both groups if CI-DME with vision loss (≥10 letters at 1 visit or 5-9 letters at 2 consecutive visits) or high-risk proliferative diabetic retinopathy (PDR) developed. Main Outcomes and Measures Development of CI-DME with vision loss or PDR through May 2020, when the last 2-year visit was completed. Results Among the 328 participants (57.6% men [230 of 399 eyes]; mean [SD] age, 56 [11] years), the 2-year cumulative probability of developing CI-DME with vision loss or PDR was 16.3% with aflibercept vs 43.5% with sham. The overall hazard ratio for either outcome was 0.32 (97.5% CI, 0.21-0.50; P < .001), favoring aflibercept. The 2-year cumulative probability of developing PDR was 13.5% in the aflibercept group vs 33.2% in the sham group, and the 2-year cumulative probability of developing CI-DME with vision loss was 4.1% in the aflibercept group vs 14.8% in the sham group. The mean (SD) change in visual acuity from baseline to 2 years was -0.9 (5.8) letters with aflibercept and -2.0 (6.1) letters with sham (adjusted mean difference, 0.5 letters [97.5% CI, -1.0 to 1.9 letters]; P = .47). Conclusions and Relevance In this randomized clinical trial, among eyes with moderate to severe NPDR, the proportion of eyes that developed PDR or vision-reducing CI-DME was lower with periodic aflibercept compared with sham treatment. However, through 2 years, preventive treatment did not confer visual acuity benefit compared with observation plus treatment with aflibercept only after development of PDR or vision-reducing CI-DME. The 4-year results will be important to assess longer-term visual acuity outcomes. Trial Registration ClinicalTrials.gov Identifier: NCT02634333.",2021,"The overall hazard ratio for either outcome was 0.32 (97.5% CI, 0.21-0.50; P < .001), favoring aflibercept.","['Participants\n\n\nData for this study were collected between January 15, 2016, and May 28, 2020, from the ongoing DRCR Retina Network Protocol W randomized clinical trial, conducted at 64 US and Canadian sites among 328 adults (399 eyes) with moderate to severe NPDR (Early Treatment Diabetic Retinopathy Study severity level, 43-53), without CI-DME', 'nonproliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME', 'eyes with moderate to severe NPDR', 'Diabetic Retinopathy', '328 participants (57.6% men [230 of 399 eyes]; mean [SD] age, 56 [11] years']","['aflibercept injections', 'intravitreous aflibercept injections', 'anti-vascular endothelial growth factor injections', 'Intravitreous Anti-Vascular Endothelial Growth Factor vs Sham Treatment', 'aflibercept', 'Aflibercept']","['mean (SD) change in visual acuity', '2-year cumulative probability of developing CI-DME with vision loss or PDR', '2-year cumulative probability of developing PDR', 'PDR or vision-reducing CI-DME', 'visual acuity benefit', 'Measures\n\n\nDevelopment of CI-DME with vision loss or PDR', 'overall hazard ratio', '2-year cumulative probability of developing CI-DME with vision loss']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0004606', 'cui_str': 'Nonproliferative diabetic retinopathy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}, {'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.545998,"The overall hazard ratio for either outcome was 0.32 (97.5% CI, 0.21-0.50; P < .001), favoring aflibercept.","[{'ForeName': 'Raj K', 'Initials': 'RK', 'LastName': 'Maturi', 'Affiliation': 'Midwest Eye Institute, Department of Ophthalmology, Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Glassman', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Josic', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Antoszyk', 'Affiliation': 'Charlotte Eye Ear Nose and Throat Associates, PA, Charlotte, North Carolina.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Blodi', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Wisconsin-Madison, Madison.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Jampol', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Dennis M', 'Initials': 'DM', 'LastName': 'Marcus', 'Affiliation': 'Southeast Retina Center, PC, Augusta, Georgia.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Martin', 'Affiliation': 'Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Melia', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Salehi-Had', 'Affiliation': 'Retina Associates of Southern California, Huntington Beach.'}, {'ForeName': 'Cynthia R', 'Initials': 'CR', 'LastName': 'Stockdale', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Omar S', 'Initials': 'OS', 'LastName': 'Punjabi', 'Affiliation': 'Charlotte Eye Ear Nose and Throat Associates, PA, Charlotte, North Carolina.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Sun', 'Affiliation': 'Joslin Diabetes Center, Beetham Eye Institute, Harvard Department of Ophthalmology, Boston, Massachusetts.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2021.0606'] 2965,33785490,"Study protocol of the global Effisayil 1 Phase II, multicentre, randomised, double-blind, placebo-controlled trial of spesolimab in patients with generalized pustular psoriasis presenting with an acute flare.","INTRODUCTION Generalized pustular psoriasis (GPP) is a rare, potentially life-threatening disease characterised by recurrent flares of widespread neutrophilic aseptic skin pustular eruption. Despite the availability of approved biologics for GPP in Japan, Taiwan and Thailand, associated evidence is largely based on uncontrolled studies in which acute flares were not directly assessed. Therefore, there is a high unmet need to investigate new rapid-acting effective treatments that resolve symptoms associated with acute GPP flares. A prior Phase I proof-of-concept study showed rapid improvements in skin and pustule clearance with a single intravenous dose of spesolimab, a novel anti-interleukin-36 receptor antibody, in patients presenting with an acute GPP flare. Here, we present the design and rationale of Effisayil 1, a global, Phase II, placebo-controlled study to evaluate the efficacy, safety and tolerability of spesolimab in patients presenting with an acute GPP flare. METHODS AND ANALYSIS At least 51 patients with an acute GPP flare will be randomised 2:1 to receive a single 900 mg intravenous dose of spesolimab or placebo and followed for up to 28 weeks. The primary endpoint is a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation subscore of 0 (pustule clearance) at Week 1. The key secondary endpoint is a GPPGA score of 0 or 1 (clear or almost clear) at Week 1. Safety will be assessed over the study duration by the occurrence of treatment-emergent adverse events. Blood and skin biopsies will be collected to assess biomarkers. Superiority of spesolimab over placebo in the proportion of patients achieving the primary and key secondary endpoints will be evaluated. ETHICS AND DISSEMINATION The study complies with the ethical principles of the Declaration of Helsinki, the International Council for Harmonisation's Good Clinical Practice and local regulations. Ethics committee approvals have been obtained for each centre from all participating countries and are listed in online supplementary file 1. Primary results will be published in a peer-reviewed journal. TRIAL REGISTRATION DETAILS ClinicalTrials.gov identifier: NCT03782792; Pre-results.",2021,The primary endpoint is a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation subscore of 0 (pustule clearance) at Week 1.,"['patients with generalized pustular psoriasis presenting with an acute flare', 'patients presenting with an acute GPP flare', 'At least 51 patients with an acute GPP flare']","['single 900\u2009mg intravenous dose of spesolimab or placebo', 'placebo', 'spesolimab']","['efficacy, safety and tolerability', 'GPPGA score of 0 or 1 (clear or almost clear', 'Blood and skin biopsies', 'Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation subscore of 0 (pustule clearance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0343055', 'cui_str': 'Generalized pustular psoriasis'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0343056', 'cui_str': 'Generalized pustular psoriasis of von Zumbush'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0343055', 'cui_str': 'Generalized pustular psoriasis'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0150866', 'cui_str': 'Biopsy of skin'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0241157', 'cui_str': 'Pustule'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",,0.3544,The primary endpoint is a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation subscore of 0 (pustule clearance) at Week 1.,"[{'ForeName': 'Siew Eng', 'Initials': 'SE', 'LastName': 'Choon', 'Affiliation': 'Jeffrey Cheah School of Medicine and Health Sciences, Clinical School Johor Bahru, Monash University Malaysia, Johor Bahru, Johor, Malaysia.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Lebwohl', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Slaheddine', 'Initials': 'S', 'LastName': 'Marrakchi', 'Affiliation': 'Dermatology Department, Hedi Chaker University Hospital, Sfax, Tunisia.'}, {'ForeName': 'A David', 'Initials': 'AD', 'LastName': 'Burden', 'Affiliation': 'Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Tsen-Fang', 'Initials': 'TF', 'LastName': 'Tsai', 'Affiliation': 'Department of Dermatology, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Akimichi', 'Initials': 'A', 'LastName': 'Morita', 'Affiliation': 'Department of Geriatric and Environmental Dermatology, Nagoya City University, Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Navarini', 'Affiliation': 'Department of Dermatology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zheng', 'Affiliation': 'Department of Dermatology, Second Affiliated Hospital, Zhejiang University, School of Medicine, Hangzhou, China.'}, {'ForeName': 'Jinhua', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Dermatology, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Hamida', 'Initials': 'H', 'LastName': 'Turki', 'Affiliation': 'Dermatology Department, Hedi Chaker University Hospital, Sfax, Tunisia.'}, {'ForeName': 'Sushmita', 'Initials': 'S', 'LastName': 'Rajeswari', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Ridgefield, Connecticut, USA.'}, {'ForeName': 'Hongjie', 'Initials': 'H', 'LastName': 'Deng', 'Affiliation': 'Boehringer Ingelheim (China), Investment Co Ltd, Shanghai, China.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Tetzlaff', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Thoma', 'Affiliation': 'Boehringer Ingelheim International GmbH, Biberach, Germany.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Bachelez', 'Affiliation': 'Service de Dermatologie, Assistance Publique-Hôpitaux de Paris Hôpital Saint-Louis, Paris, France herve.bachelez@aphp.fr.'}]",BMJ open,['10.1136/bmjopen-2020-043666'] 2966,33785406,Electroconvulsive therapy with a memory reactivation intervention for post-traumatic stress disorder: A randomized controlled trial.,"BACKGROUND Post-traumatic Stress Disorder (PTSD) often does not respond to available treatments. Memories are vulnerable to disruption during reconsolidation, and electroconvulsive therapy (ECT) has amnestic effects OBJECTIVE/HYPOTHESIS: To test the use of ECT to disrupt the reconsolidation of traumatic memories as a potential treatment for PTSD METHODS: Participants were adults from the civilian population and were referred for ECT treatment for severe depression with comorbid PTSD symptoms. Twenty-eight participants were randomly assigned to reactivation of a traumatic or non-traumatic memory using audio script driven imagery prior to each ECT treatment. Primary outcomes were change in scores on the Modified PTSD Symptom Scale - Self Report (MPSS-SR) and the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Secondary outcomes included a comparison of the change in heart rate while listening to the script RESULTS: Twenty-five female patients who completed a post-ECT assessment were included in the analysis. No significant group differences were found in the MPSS-SR or CAPS-5 scores from pre-ECT to post-ECT or 3-month follow-ups. However, both groups improved at post-ECT and 3-month follow up. Partial eta squared estimates of effect size showed large effect sizes for all outcomes (η 2  > 0.13). Changes in heart rate were not significantly different between groups or over time CONCLUSIONS: ECT paired with pre-treatment traumatic memory reactivation was not more effective for treating PTSD symptoms than ECT with non-traumatic memory reactivation. While our primary hypothesis was not supported, our data provides further support for the efficacy of ECT for improving symptoms of PTSD with comorbid depression. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04027452. IDENTIFIER NCT04027452.",2021,,['Post-Traumatic Stress Disorder'],['Electroconvulsive Therapy with a Memory Reactivation Intervention'],[],"[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.143172,,"[{'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Tang', 'Affiliation': 'Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Ontario, Canada; Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Trought', 'Affiliation': 'Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Gicas', 'Affiliation': 'Department of Psychology, York University, Toronto, Ontario, Canada.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Kozak', 'Affiliation': 'Department of Psychiatry, University of Toronto, Ontario, Canada.'}, {'ForeName': 'Sheena A', 'Initials': 'SA', 'LastName': 'Josselyn', 'Affiliation': 'Program in Neurosciences & Mental Health, Hospital for Sick Children, Toronto, Ontario, Canada; Institute of Medical Sciences, University of Toronto, Toronto, Ontario, Canada; Department of Physiology, University of Toronto, Ontario, Canada; Department of Psychology, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Department of Psychiatry, UC San Diego Health, La Jolla, California, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Ontario, Canada; Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Institute of Medical Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Voineskos', 'Affiliation': 'Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Ontario, Canada; Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Institute of Medical Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Knyahnytska', 'Affiliation': 'Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Ontario, Canada; Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Suvercha', 'Initials': 'S', 'LastName': 'Pasricha', 'Affiliation': 'Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Ontario, Canada.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Chung', 'Affiliation': 'Department of Psychiatry, University of Toronto, Ontario, Canada.'}, {'ForeName': 'Young', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Department of Pharmacology & Toxicology, University of Toronto, Ontario, Canada.'}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Isserles', 'Affiliation': 'The Jerusalem Center for Mental Health, Jerusalem, Israel.'}, {'ForeName': 'Albert H C', 'Initials': 'AHC', 'LastName': 'Wong', 'Affiliation': 'Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Ontario, Canada; Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Institute of Medical Sciences, University of Toronto, Toronto, Ontario, Canada; Department of Pharmacology & Toxicology, University of Toronto, Ontario, Canada. Electronic address: albert.wong@utoronto.ca.'}]",Brain stimulation,['10.1016/j.brs.2021.03.015'] 2967,33787584,Vitamin D supplementation and improvement of pneumonic children at a tertiary pediatric hospital in Egypt: A randomized controlled trial.,"BACKGROUND Despite the well-recognized effect of vitamin D in metabolism and homeostasis, there is now growing interest in its probable association with pneumonia. This study aims to supply vitamin D3 (Cholecalciferol) (100,000 IU) to pneumonic children to minimize the duration of illness and improve their outcome. METHODS A double-blinded, randomized, placebo-controlled trial was conducted in a Pediatric Cairo University affiliated hospital. An intervention arm (93 children) and a control arm (98 children), who had pneumonia with an insufficient or deficient level of vitamin D and whose parental permission was obtained, were enrolled in the trial. All children were treated with antibiotics according to WHO guidelines. Children were given a single injection of 1 mL of 100,000 IU of vitamin D3 or placebo. Clinical data were recorded every eight hours for all children. Outcomes were assessed 7 days after vitamin D injection.The primary outcome variable was the change in serum level of 25(OH)D, while the secondary outcomes were the medical state of the assigned cases (improvement or death) and duration between enrollment and hospital discharge for improved cases. RESULTS In the supplementation group, the percentage of patients who suffered either deficient (38.7%) or insufficient levels (61.3%) of 25 (OH)D at day one had significantly decreased in the seventh day to (11.8%) and (52.7%), respectively. Kaplan--Meier plots highlighted that the median time to recover of the placebo group was significantly longer than that of the supplementation group (Log Rank P value < .001). CONCLUSION VDD was detected in pediatric critical care children. In pneumonic children with high VDD, it is illustrated that Vitamin D supplementation is accompanied by lowered mortality risk and pSOFA scores, reduced time to recover, and improved PaO2/FiO2. TRIAL REGISTRATION Trial Identifier number: NCT04244474. Registered on 27 January 2020- Retrospectively registered at ClinicalTrials.gov https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S0009JXO&selectaction=Edit&uid=U0004UO8&ts=152&cx=9cceq6.",2021,Meier plots highlighted that the median time to recover of the placebo group was significantly longer than that of the supplementation group (Log Rank P value ,"['Pediatric Cairo University affiliated hospital', 'pneumonic children with high VDD', 'An intervention arm (93 children) and a control arm (98 children), who had pneumonia with an insufficient or deficient level of vitamin D and whose parental permission was obtained, were enrolled in the trial', '27 January 2020', 'pneumonic children at a tertiary pediatric hospital in Egypt', 'pediatric critical care children']","['supply vitamin D3 (Cholecalciferol', 'Vitamin D supplementation', 'vitamin D', 'Kaplan', 'placebo', 'vitamin D3 or placebo']","['change in serum level of 25(OH)D', 'medical state of the assigned cases (improvement or death) and duration between enrollment and hospital discharge for improved cases', 'mortality risk and pSOFA scores, reduced time to recover, and improved PaO2/FiO2', 'VDD', 'median time to recover']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0521104', 'cui_str': 'With permission of'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.85586,Meier plots highlighted that the median time to recover of the placebo group was significantly longer than that of the supplementation group (Log Rank P value ,"[{'ForeName': 'John Rene', 'Initials': 'JR', 'LastName': 'Labib', 'Affiliation': 'Pediatrics Department.'}, {'ForeName': 'Sally Kamal', 'Initials': 'SK', 'LastName': 'Ibrahem', 'Affiliation': 'Pediatrics Department.'}, {'ForeName': 'Mohamed M', 'Initials': 'MM', 'LastName': 'Ismail', 'Affiliation': 'Pediatrics Department.'}, {'ForeName': 'Shaimaa A M Abd El', 'Initials': 'SAMAE', 'LastName': 'Fatah', 'Affiliation': 'Public Health Department.'}, {'ForeName': 'Amal Samir', 'Initials': 'AS', 'LastName': 'Sedrak', 'Affiliation': 'Public Health Department.'}, {'ForeName': 'Mona Adel Soliman', 'Initials': 'MAS', 'LastName': 'Attia', 'Affiliation': 'Public Health Department.'}, {'ForeName': 'Hadeel Mohammad', 'Initials': 'HM', 'LastName': 'El-Hanafi', 'Affiliation': 'Clinical and Chemical Pathology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mai Hamed', 'Initials': 'MH', 'LastName': 'Kamel', 'Affiliation': 'Clinical and Chemical Pathology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",Medicine,['10.1097/MD.0000000000025011'] 2968,33787576,Basic life support training programme in schools by school nurses: How long and how often to train?,"BACKGROUND Cardiopulmonary resuscitation (CPR) training in schools, despite being legislated in Spain, is not established as such within the subjects that children are taught in schools. OBJECTIVE to evaluate the acquisition of CPR skills by 11-year-old children after a brief theoretical-practical teaching programme taught by nurses at school. METHODS 62 students were assessed in a quasi-experimental study on 2 cohorts (51.4% of the sample in control group [CG]). In total, 2 sessions were given, a theoretical one, and a practical training for skill development in children, in which the CG performed the CPR in 2-minute cycles and the intervention group in 1-minute cycles. The anthropometric variables recorded were weight and height, and the variables compression quality and ventilation quality were recorded using the Laerdal ResusciAnne manikin with Personal Computer/Wireless SkillReport. RESULTS The assessment showed better results, in terms of BLS sequence performance and use of automated external defibrillator, in the CG and after training, except for the evaluation of the 10-second breathing assessment technique. The quality of chest compressions was better in the CG after training, as was the quality of the ventilations. There were no major differences in CPR quality after training and 4 months after the 1-minute and 2-minute training cycles. CONCLUSIONS 11-year-old children do not perform quality chest compressions or ventilations but, considering their age, they are able to perform a BLS sequence correctly.",2021,"There were no major differences in CPR quality after training and 4 months after the 1-minute and 2-minute training cycles. ","['62 students were assessed in a quasi-experimental study on 2 cohorts (51.4% of the sample in control group [CG', 'schools by school nurses', '11-year-old children after a brief theoretical-practical teaching programme taught by nurses at school', '11-year-old children']","['Cardiopulmonary resuscitation (CPR) training', 'Basic life support training programme']","['BLS sequence performance and use of automated external defibrillator', 'CPR quality', 'variables compression quality and ventilation quality', 'quality of chest compressions']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0302833', 'cui_str': 'School nurse'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085873', 'cui_str': 'Basic life support'}]","[{'cui': 'C0005859', 'cui_str': 'Bloom syndrome'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0180309', 'cui_str': 'Automated External Defibrillators'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}]",62.0,0.0059091,"There were no major differences in CPR quality after training and 4 months after the 1-minute and 2-minute training cycles. ","[{'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Martínez-Isasi', 'Affiliation': 'Life Support and Medical Simulation Research Group, Health Research Institute of Santiago de Compostela (IDIS), Santiago de Compostela, Spain; CLINURSID Research Group. Faculty of Nursing, University of Santiago de Compostela, Santiago de Compostela.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'García-Suárez', 'Affiliation': 'Servicio de Anestesia y Reanimación, Complejo Asistencial Universitario de León (CAULE), Gerencia Regional de Salud de Castilla y León (SACYL), Leon.'}, {'ForeName': 'Medea Aglaya', 'Initials': 'MA', 'LastName': 'De La Peña Rodríguez', 'Affiliation': 'Primary Care Board Management. Guayaba Health Center, Madrid Health Service, Madrid.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Gómez-Salgado', 'Affiliation': 'Department of Sociology, Faculty of Labour Sciences, Social Work and Public Health, University of Huelva, Huelva.'}, {'ForeName': 'Nélida', 'Initials': 'N', 'LastName': 'Fernández', 'Affiliation': 'Department of Biomedical Sciences, Institute of Biomedicine (IBIOMED), University of Leon, Leon.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Méndez-Martínez', 'Affiliation': 'Servicio de Anestesia y Reanimación, Complejo Asistencial Universitario de León (CAULE), Gerencia Regional de Salud de Castilla y León (SACYL), Leon.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Leon-Castelao', 'Affiliation': 'Clinical Simulation Lab, School of Medicine and Healthcare Sciences, University of Barcelona.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Clemente-Vivancos', 'Affiliation': 'Clinical Simulation Lab, School of Medicine and Healthcare Sciences, University of Barcelona.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Fernández-García', 'Affiliation': 'Unidad de Radiología Vascular Intervencionista, Complejo Asistencial Universitario de León (CAULE), Gerencia Regional de Salud de Castilla y León (SACYL), Leon, Spain.'}]",Medicine,['10.1097/MD.0000000000024819'] 2969,33784875,"Effects of Cognitive Behavioral Therapy for Depression and Anxiety, Response Rates and Adverse Events in Patients with Locoregional Advanced Nasopharyngeal Carcinoma.","PURPOSE This retrospective study investigated the effects of cognitive behavioral therapy (CBT) on depression, anxiety, response rates, and adverse events in patients with locoregional advanced nasopharyngeal carcinoma (NPC). METHODS A total of 269 patients with diagnosis of stage III-IVA NPC received either CBT plus chemoradiotherapy (CBT group, n = 136) or treatment as usual (TAU) plus chemoradiotherapy (TAU group, n = 133). Patients in the CBT group received a series of 6 CBT sessions for 6 weeks during concurrent chemoradiotherapy. Depression and anxiety were assessed using the Hospital Anxiety and Depression Scale (HADS) score at baseline, the completion of radiotherapy, and 6, 12, and 24 months after radiotherapy. Response rates and adverse events were also evaluated. RESULTS Patients in the CBT group showed significantly less depression and anxiety than patients in the TAU group after the completion of radiotherapy ( P  < .05). Complete response rates were 99.3% (135/136) and 92.5% (123/133) in the CBT group and TAU group with a small effect size (Phi coefficient = .171), respectively ( P  = .005). Compared with the TAU group, the CBT group showed a significantly lower incidence of acute adverse events and late toxic effects. CONCLUSIONS The addition of CBT to chemoradiotherapy significantly reduced depressive and anxiety symptoms. CBT combined with chemoradiotherapy is associated with improved response rates, with reduced incidence of toxic effects in patients with locoregional advanced NPC. Based on this study, we registered a randomized controlled clinical trials to better define the role of CBT in patients with locoregional advanced NPC (Registration number: ChiCTR2000034701).",2021,"RESULTS Patients in the CBT group showed significantly less depression and anxiety than patients in the TAU group after the completion of radiotherapy ( P  < .05).","['Patients with Locoregional Advanced Nasopharyngeal Carcinoma', 'patients with locoregional advanced nasopharyngeal carcinoma (NPC', 'patients with locoregional advanced NPC (Registration number', 'patients with locoregional advanced NPC', '269 patients with diagnosis of stage III-IVA NPC']","['CBT combined with chemoradiotherapy', 'CBT', 'cognitive behavioral therapy (CBT', 'radiotherapy', 'Cognitive Behavioral Therapy', 'CBT plus chemoradiotherapy (CBT group, n\u2009=\u2009136) or treatment as usual (TAU) plus chemoradiotherapy (TAU', 'TAU', 'CBT to chemoradiotherapy']","['Complete response rates', 'Response rates and adverse events', 'response rates', 'acute adverse events and late toxic effects', 'depression and anxiety', 'toxic effects', 'Hospital Anxiety and Depression Scale (HADS) score', 'Depression and Anxiety, Response Rates and Adverse Events', 'depression, anxiety, response rates, and adverse events', 'depressive and anxiety symptoms', 'Depression and anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",269.0,0.0411735,"RESULTS Patients in the CBT group showed significantly less depression and anxiety than patients in the TAU group after the completion of radiotherapy ( P  < .05).","[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Radiation Oncology, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Sheng-Nan', 'Initials': 'SN', 'LastName': 'Fu', 'Affiliation': 'Department of Radiation Oncology, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Yan-Zhu', 'Initials': 'YZ', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Ou-Ying', 'Initials': 'OY', 'LastName': 'Yan', 'Affiliation': 'Department of Radiation Oncology, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Tong', 'Affiliation': 'Psychological Clinic, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Wang-Lian', 'Initials': 'WL', 'LastName': 'Peng', 'Affiliation': 'Department of Hospice Unit, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Zou', 'Affiliation': 'Department of Hospice Unit, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Min-Ni', 'Initials': 'MN', 'LastName': 'Wen', 'Affiliation': 'Department of Clinical Spiritual Care, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Clinical Spiritual Care, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Hong-Zhi', 'Initials': 'HZ', 'LastName': 'Ma', 'Affiliation': 'Department of Radiation Oncology, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': 'Department of Radiation Oncology, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Radiation Oncology, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xu-Fen', 'Initials': 'XF', 'LastName': 'Huang', 'Affiliation': 'Department of Hospice Unit, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Ya-Qian', 'Initials': 'YQ', 'LastName': 'Han', 'Affiliation': 'Department of Radiation Oncology, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xiao-Hong', 'Initials': 'XH', 'LastName': 'Liu', 'Affiliation': 'Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, China.'}]",Integrative cancer therapies,['10.1177/15347354211006179'] 2970,33784598,"Tocilizumab vs placebo for the treatment of giant cell arteritis with polymyalgia rheumatica symptoms, cranial symptoms or both in a randomized trial.","OBJECTIVE The randomized, placebo (PBO)-controlled GiACTA trial demonstrated the efficacy and safety of tocilizumab (TCZ) in patients with giant cell arteritis (GCA). The present study evaluated the efficacy of TCZ in patients with GCA presenting with polymyalgia rheumatica (PMR) symptoms only, cranial symptoms only or both PMR and cranial symptoms in the GiACTA trial. METHODS In GiACTA, 250 patients with GCA received either TCZ weekly or every other week plus a 26-week prednisone taper or PBO plus a 26- or 52-week prednisone taper. This post hoc analysis assessed baseline characteristics, sustained remission rate, number of flares, annualized flare rate, time to flare, cumulative prednisone dose, methotrexate use and safety in patients with PMR symptoms only, cranial symptoms only or both at baseline. RESULTS Overall, 52 patients had PMR symptoms only, 94 had cranial symptoms only and 104 had both symptoms at baseline. At Week 52, rates of sustained remission were significantly higher with TCZ vs PBO in all 3 groups (PMR only, 45.2% vs 19.0%, P = 0.0446; cranial only, 60.3% vs 19.4%, P = 0.0001; PMR and cranial, 55.0% vs 11.4%, P < 0.0001). Smaller proportions of TCZ-treated patients experienced disease flare than PBO-treated patients across all groups (PMR only, 41.9% vs 57.1%; cranial only, 20.7% vs 47.2%; PMR and cranial, 31.7% vs 81.8%). Annualized flare rate and risk of flare were significantly lower with TCZ vs PBO for patients with cranial symptoms only and both symptoms; they were numerically lower, but did not reach statistical significance, in the smaller group of patients with PMR symptoms only. CONCLUSIONS TCZ improved clinical outcomes in patients who presented with PMR symptoms only, cranial symptoms only or both at baseline, suggesting that TCZ is effective in patients with GCA regardless of the presenting clinical phenotype.",2021,"Annualized flare rate and risk of flare were significantly lower with TCZ vs PBO for patients with cranial symptoms only and both symptoms; they were numerically lower, but did not reach statistical significance, in the smaller group of patients with PMR symptoms only. ","['patients with giant cell arteritis (GCA', 'patients with GCA presenting with polymyalgia rheumatica (PMR) symptoms only, cranial symptoms only or both PMR and cranial symptoms in the GiACTA trial', '250 patients with GCA']","['tocilizumab (TCZ', 'Tocilizumab vs placebo', 'prednisone taper or PBO plus a 26- or 52-week prednisone taper', 'placebo', 'TCZ']","['baseline characteristics, sustained remission rate, number of flares, annualized flare rate, time to flare, cumulative prednisone dose, methotrexate use and safety in patients with PMR symptoms only, cranial symptoms', 'cranial symptoms', 'Annualized flare rate and risk of flare', 'PMR symptoms', 'rates of sustained remission', 'disease flare']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039483', 'cui_str': 'Giant cell arteritis'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0032533', 'cui_str': 'Polymyalgia rheumatica'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C2348831', 'cui_str': '250'}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032533', 'cui_str': 'Polymyalgia rheumatica'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",250.0,0.0780824,"Annualized flare rate and risk of flare were significantly lower with TCZ vs PBO for patients with cranial symptoms only and both symptoms; they were numerically lower, but did not reach statistical significance, in the smaller group of patients with PMR symptoms only. ","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Spiera', 'Affiliation': 'Hospital for Special Surgery, Department of Medicine, New York, NY, USA. Electronic address: spierar@hss.edu.'}, {'ForeName': 'Sebastian H', 'Initials': 'SH', 'LastName': 'Unizony', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Bao', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Luder', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Pavlov', 'Affiliation': 'Everest Clinical Research, Markham, Ontario, Canada.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Stone', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}]",Seminars in arthritis and rheumatism,['10.1016/j.semarthrit.2021.03.006'] 2971,33787625,A prospective randomized controlled trial to evaluate effect of chewing gum on postoperative ileus in elderly patient after hip fracture.,"ABSTRACT Factors related to developing postoperative ileus (POI) vary from pharmacologic, inflammatory, hormonal, metabolic, gastrointestinal physiology, neurologic, to psychological factors. Although orthopedic-related incidence of postoperative ileus is about 10%, these studies are limited to spine surgery and pelvic surgery. The purpose of this study was to investigate prevalence of POI and to analyze effect of chewing gum on POI and bowel function in elderly patients after hip fracture surgery.A prospective randomized controlled trial was conducted at the Gyeongsang National University Hospital. Elderly patients with hip fracture who underwent surgery from March 2017 to June 2018 were eligible to participate. Patients were excluded if they had a mastication disability, impaired cognitive function, previous history of gastrointestinal disease, respiratory disease and low oxygen saturation, hip arthroplasty with causes other than hip fractures, acetabular fractures, periprosthetic fractures, or pathological fractures. Patients with consciousness problem by excessive anesthesia were also excluded. Patients were classified into 2 groups by randomization. Group I received sugar-free gum and were encouraged to chew 6 hours following surgery until the first intestinal gas is released. Group II was given the same postoperative procedure and encouraged to consume water after 6 hours.After applying exclusion criteria, 74 patients were finally included. Thirty-one patients were classified to Group I and 43 patients were classified to the Group II. Prevalence of POI in all patients with hip fracture was 63.5% (47/74). Prevalence of POI in Group I was statistically significant lower than that in Group II (Group I: 41%, Group II: 79.1%, P = .01)The prevalence of POI in elderly patients with hip fracture was 63.5%. Chewing gum had a significant effect on reduction of POI in elderly patients with hip fractures.",2021,I was statistically significant lower than that in Group II,"['Patients were excluded if they had a mastication disability, impaired cognitive function, previous history of gastrointestinal disease, respiratory disease and low oxygen saturation, hip arthroplasty with causes other than hip fractures, acetabular fractures, periprosthetic fractures, or pathological fractures', 'elderly patients after hip fracture surgery', 'Elderly patients with hip fracture who underwent surgery from March 2017 to June 2018 were eligible to participate', 'elderly patients with hip fractures', 'elderly patient after hip fracture', 'elderly patients with hip fracture was 63.5', 'Patients with consciousness problem by excessive anesthesia', '74 patients were finally included', 'Gyeongsang National University Hospital']","['chewing gum', 'Chewing gum', 'sugar-free gum']","['Prevalence of POI', 'reduction of POI', 'postoperative ileus', 'POI and bowel function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0455553', 'cui_str': 'H/O: gastrointestinal disease'}, {'cui': 'C0035204', 'cui_str': 'Disorder of respiratory system'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0186193', 'cui_str': 'Repair of hip'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205394', 'cui_str': 'Other'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0347804', 'cui_str': 'Fracture of acetabulum'}, {'cui': 'C2609162', 'cui_str': 'Periprosthetic fracture'}, {'cui': 'C0016663', 'cui_str': 'Pathological fracture'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0009791', 'cui_str': 'Consciousness related finding'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0008037', 'cui_str': 'Chewing Gum'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0400877', 'cui_str': 'Postoperative ileus'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}]",31.0,0.00680815,I was statistically significant lower than that in Group II,"[{'ForeName': 'Yong-Han', 'Initials': 'YH', 'LastName': 'Cha', 'Affiliation': 'Department of Orthopaedic Surgery, Eulji University Hospital, Daejeon.'}, {'ForeName': 'Dae Cheol', 'Initials': 'DC', 'LastName': 'Nam', 'Affiliation': 'Department of Orthopaedic Surgery and Institute of Health Sciences, Gyeongsang National University School of Medicine and Gyeongsang National University Hospital, Jinju.'}, {'ForeName': 'Sang-Youn', 'Initials': 'SY', 'LastName': 'Song', 'Affiliation': 'Department of Orthopaedic Surgery, School of Medicine, Gyeongsang National University Hospital, Korea.'}, {'ForeName': 'Jun-Il', 'Initials': 'JI', 'LastName': 'Yoo', 'Affiliation': 'Department of Orthopaedic Surgery, School of Medicine, Gyeongsang National University Hospital, Korea.'}]",Medicine,['10.1097/MD.0000000000025321'] 2972,33787615,Physical exercise and prevention of falls. Effects of a Pilates training method compared with a general physical activity program: A randomized controlled trial.,"INTRODUCTION Falls are the leading cause of injury-related mortality and morbidity in the elderly. Physical activity plays a key role in the prevention of falls and stimulates postural control. The aim of this study was to compare a general physical activity program for the elderly with a Pilates program to evaluate the effects on balance and on reducing the risk of falling. MATERIALS AND METHODS Forty-six subjects were enrolled in this study, but only 41 were included in the study. The subjects were divided into 2 groups: Pilates group (P-G) and a group following a nonspecific program of physical activity (Pa-G). Each subject underwent the hand grip test, Berg balance scale test, and posturographic analysis. RESULTS Spearman correlation coefficient showed correlations between the following parameters: BBS versus hand grip test (r = 0.68); BBS versus ellipse surface area (r = -0.75). There were significant differences between groups after the exercise program: both groups showed an improvement in performance but the P-G recorded significantly better results than the Pa-G. DISCUSSION AND CONCLUSIONS This study confirmed that physical activity improves both balance and strength. However, our data show that Pilates has a greater effect on these physical abilities than a general physical activity program.",2021,"There were significant differences between groups after the exercise program: both groups showed an improvement in performance but the P-G recorded significantly better results than the Pa-G. DISCUSSION AND CONCLUSIONS ","['Forty-six subjects were enrolled in this study, but only 41 were included in the study']","['Pilates training method compared with a general physical activity program', 'general physical activity program', 'Physical exercise', 'nonspecific program of physical activity (Pa-G']",['risk of falling'],"[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",46.0,0.00243454,"There were significant differences between groups after the exercise program: both groups showed an improvement in performance but the P-G recorded significantly better results than the Pa-G. DISCUSSION AND CONCLUSIONS ","[{'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Patti', 'Affiliation': 'Department of Psychology, Educational Science and Human Movement, University of Palermo.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Zangla', 'Affiliation': 'Department of Psychology, Educational Science and Human Movement, University of Palermo.'}, {'ForeName': 'Fatma Nese', 'Initials': 'FN', 'LastName': 'Sahin', 'Affiliation': 'Faculty of Sport Science, Ankara University, Turkey.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Cataldi', 'Affiliation': 'Department of Basic Medical Sciences, Neurosciences and Sense Organs, School of Medicine, University of Study of Bari.'}, {'ForeName': 'Gioacchino', 'Initials': 'G', 'LastName': 'Lavanco', 'Affiliation': 'Department of Psychology, Educational Science and Human Movement, University of Palermo.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Palma', 'Affiliation': 'Department of Psychology, Educational Science and Human Movement, University of Palermo.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Fischietti', 'Affiliation': 'Department of Basic Medical Sciences, Neurosciences and Sense Organs, School of Medicine, University of Study of Bari.'}]",Medicine,['10.1097/MD.0000000000025289'] 2973,33785676,Comparison of ultrasonography guided serratus anterior plane block and thoracic paravertebral block in video-assisted thoracoscopic surgery: a prospective randomized double-blind study.,"Background Various truncal block techniques with ultrasonography (USG) are becoming widespread to reduce postoperative pain and opioid requirements in video-assisted thoracoscopic surgery (VATS). The primary aim of our study was to determine whether the USG-guided serratus anterior plane block (SAPB) is as effective as the thoracic paravertebral block (TPVB) in VATS. Our secondary aim was to evaluate patient and surgeon satisfaction, block application time, first analgesic time, and length of hospital stay. Methods Patients in Group SAPB received 0.4 mL/kg bupivacaine with a USG-guided SAPB, and patients in Group TPVB received 0.4 mL/kg bupivacaine with a USG-guided TPVB. We recorded the pain scores, the timing of the first analgesic requirement, the amount of tramadol consumption, and postoperative complications for 24 hours. We also recorded the block application time and length of hospital stay. Results A total of 62 patients, with 31 in each group (Group SAPB and Group TPVB) completed the study. Between the two groups, there were no significant differences in rest and dynamic pain visual analog scale scores at 0, 1, 6, 12, and 24 hours after surgery. The total consumption of tramadol was significantly lower in the TPVB group ( P = 0.026). The block application time was significantly shorter in Group SAPB ( P < 0.001). Conclusions An SAPB that is applied safely and rapidly as a part of multimodal analgesia in patients who undergo VATS is not inferior to the TPVB and can be an alternative to it.",2021,The total consumption of tramadol was significantly lower in the TPVB group ( P = 0.026).,"['62 patients, with 31 in each group (Group SAPB and Group TPVB) completed the study']","['USG-guided serratus anterior plane block (SAPB', 'bupivacaine', 'TPVB', 'ultrasonography (USG', 'video-assisted thoracoscopic surgery', 'ultrasonography guided serratus anterior plane block and thoracic paravertebral block']","['block application time and length of hospital stay', 'total consumption of tramadol', 'block application time', 'pain scores, the timing of the first analgesic requirement, the amount of tramadol consumption, and postoperative complications', 'patient and surgeon satisfaction, block application time, first analgesic time, and length of hospital stay', 'rest and dynamic pain visual analog scale scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0224349', 'cui_str': 'Structure of serratus anterior muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0224349', 'cui_str': 'Structure of serratus anterior muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",62.0,0.114798,The total consumption of tramadol was significantly lower in the TPVB group ( P = 0.026).,"[{'ForeName': 'Merve Sena', 'Initials': 'MS', 'LastName': 'Baytar', 'Affiliation': 'Department of Anesthesiology and Reanimation, Zonguldak Atatürk State Hospital, Zonguldak, Turkey.'}, {'ForeName': 'Canan', 'Initials': 'C', 'LastName': 'Yılmaz', 'Affiliation': 'Department of Anesthesiology and Reanimation, Bursa Yüksek Ihtisas Training and Education Hospital, Health Sciences University, Bursa, Turkey.'}, {'ForeName': 'Derya', 'Initials': 'D', 'LastName': 'Karasu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Bursa Yüksek Ihtisas Training and Education Hospital, Health Sciences University, Bursa, Turkey.'}, {'ForeName': 'Çağdaş', 'Initials': 'Ç', 'LastName': 'Baytar', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Zonguldak Bülent Ecevit University Medicine Faculty, Zonguldak, Turkey.'}]",The Korean journal of pain,['10.3344/kjp.2021.34.2.234'] 2974,33785674,"Does transcutaneous electrical nerve stimulation affect pain, neuropathic pain, and sympathetic skin responses in the treatment of chronic low back pain? A randomized, placebo-controlled study.","Background The purpose of this study was to assess the effectiveness of transcutaneous electrical nerve stimulation (TENS) in chronic low back pain and neuropathic pain. Methods Seventy-four patients aged 18-65 with chronic low back pain were included in the study. Baseline measurements were performed, and patients were randomized into three groups. The first group received burst TENS (bTENS), the second group conventional TENS (cTENS), and the third group placebo TENS (pTENS), all over 15 sessions. Patients' visual analogue scale (VAS) scores were evaluated before treatment (preT), immediately after treatment (postT), and in the third month after treatment (postT3). Douleur Neuropathique 4 Questions (DN4), the Modified Oswestry Low Back Pain Disability Questionnaire (MOS), the Beck Depression Inventory (BDI), and sympathetic skin response (SSR) values were also evaluated preT and postT3. Results A statistically significant improvement was observed in mean VAS scores postT compared to preT in all three groups. Intergroup comparison revealed a significant difference between preT and postT values, that difference being assessed in favor of bTENS at multiple comparison analysis. Although significant improvement was determined in neuropathic pain DN4 scores measured at postT3 compared to preT in all groups, there was no significant difference between the groups. No statistically significant difference was also observed between the groups in terms of MOS, BDI, or SSR values at postT3 ( P > 0.05). Conclusions bTENS therapy in patients with low back pain is an effective and safe method that can be employed in short-term pain control.",2021,"Although significant improvement was determined in neuropathic pain DN4 scores measured at postT3 compared to preT in all groups, there was no significant difference between the groups.","['chronic low back pain and neuropathic pain', 'Methods\n\n\nSeventy-four patients aged 18-65 with chronic low back pain were included in the study', 'patients with low back pain']","['transcutaneous electrical nerve stimulation', 'bTENS therapy', 'burst TENS (bTENS), the second group conventional TENS (cTENS), and the third group placebo TENS (pTENS', 'placebo', 'transcutaneous electrical nerve stimulation (TENS']","['visual analogue scale (VAS) scores', 'neuropathic pain DN4 scores', 'SSR) values', 'pain, neuropathic pain, and sympathetic skin responses', 'Douleur Neuropathique 4 Questions (DN4), the Modified Oswestry Low Back Pain Disability Questionnaire (MOS), the Beck Depression Inventory (BDI), and sympathetic skin response', 'mean VAS scores postT', 'MOS, BDI, or SSR values']","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0014518', 'cui_str': 'Lyell syndrome'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0394676', 'cui_str': 'Burst transcutaneous electrical nerve stimulation'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0394678', 'cui_str': 'Conventional transcutaneous electrical nerve stimulation'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0312646', 'cui_str': 'Finding related to response to skin test'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",74.0,0.0176543,"Although significant improvement was determined in neuropathic pain DN4 scores measured at postT3 compared to preT in all groups, there was no significant difference between the groups.","[{'ForeName': 'Elif', 'Initials': 'E', 'LastName': 'Yakşi', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Abant Izzet Baysal University, Faculty of Medicine, Bolu, Turkey.'}, {'ForeName': 'Ayşegül', 'Initials': 'A', 'LastName': 'Ketenci', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul University, Istanbul Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Mehmet Barış', 'Initials': 'MB', 'LastName': 'Baslo', 'Affiliation': 'Department of Neurology, Istanbul University, Istanbul Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Elif Kocasoy', 'Initials': 'EK', 'LastName': 'Orhan', 'Affiliation': 'Department of Neurology, Istanbul University, Istanbul Faculty of Medicine, Istanbul, Turkey.'}]",The Korean journal of pain,['10.3344/kjp.2021.34.2.217'] 2975,33785673,"Intravenous patient-controlled analgesia hydromorphone combined with pregabalin for the treatment of postherpetic neuralgia: a multicenter, randomized controlled study.","Background Postherpetic neuralgia (PHN) is the most common complication of acute herpes zoster. The treatment of PHN remains a challenge for clinical pain management. Despite the effectiveness of anticonvulsants, antidepressants, and lidocaine patches in reducing PHN, many patients still face intractable pain disorders. In this randomized controlled study, we evaluated whether hydromorphone through intravenous patient-controlled analgesia (IV PCA) was effective in relieving PHN. Methods Patients with PHN were randomly divided into two groups, one group received oral pregabalin with IV normal saline, another group received oral pregabalin with additional IV PCA hydromorphone for two weeks. Efficacy was evaluated at 1, 4, and 12 weeks after the end of the treatments. Results Two hundred and one patients were followed up for 12 weeks. After treatment, numerical rating scale (NRS) score of patients in the hydromorphone group was significantly lower than that of the control group, and the difference of NRS scores between the two groups was statistically significant at 4 and 12 weeks after treatment. The frequency of breakthrough pain in the hydromorphone group was significantly lower than that in the control group 1 and 4 weeks after treatment. After treatment, the quality of sleep in the hydromorphone group was significantly improved compared with the control group. The most common adverse reactions in the hydromorphone group were dizziness and nausea, with no significant respiratory depression. Conclusions IV PCA hydromorphone combined with oral pregabalin provides superior pain relief in patients with PHN, which is worthy of clinical application and promotion.",2021,The frequency of breakthrough pain in the hydromorphone group was significantly lower than that in the control group 1 and 4 weeks after treatment.,"['Methods\n\n\nPatients with PHN', 'patients with PHN', 'postherpetic neuralgia']","['PHN', 'lidocaine patches', 'hydromorphone', 'Intravenous patient-controlled analgesia hydromorphone combined with pregabalin', 'intravenous patient-controlled analgesia (IV PCA', 'PCA hydromorphone combined with oral pregabalin', 'oral pregabalin with IV normal saline, another group received oral pregabalin with additional IV PCA hydromorphone']","['frequency of breakthrough pain', 'Efficacy', 'dizziness and nausea', 'quality of sleep', 'pain relief', 'numerical rating scale (NRS) score', 'NRS scores']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032768', 'cui_str': 'Postherpetic neuralgia'}]","[{'cui': 'C0032768', 'cui_str': 'Postherpetic neuralgia'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0030131', 'cui_str': 'p-Chloramphetamine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1135120', 'cui_str': 'Breakthrough pain'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",201.0,0.0800233,The frequency of breakthrough pain in the hydromorphone group was significantly lower than that in the control group 1 and 4 weeks after treatment.,"[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Pain, Drum Tower Hospital, Medical School of Nanjing University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Chenjie', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology and Pain, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zeng', 'Affiliation': 'Department of Pain, Kunshan Hospital of Integrated Traditional Chinese and Western Medicine, Kunshan, Jiangsu, China.'}, {'ForeName': 'Zhongming', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Pain, Affiliated Hospital of Nantong University, Nantong, Jiangsu, China.'}, {'ForeName': 'Yanzhi', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': 'Department of Anesthesiology, Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.'}, {'ForeName': 'Gaojian', 'Initials': 'G', 'LastName': 'Tao', 'Affiliation': 'Department of Pain, Drum Tower Hospital, Medical School of Nanjing University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': 'Department of Pain, Drum Tower Hospital, Medical School of Nanjing University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Department of Pain, Drum Tower Hospital, Medical School of Nanjing University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Pain, Drum Tower Hospital, Medical School of Nanjing University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Taiyuan', 'Initials': 'T', 'LastName': 'Huang', 'Affiliation': 'Department of Pain, Drum Tower Hospital, Medical School of Nanjing University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Huai', 'Affiliation': 'Department of Pain, Drum Tower Hospital, Medical School of Nanjing University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Benxiang', 'Initials': 'B', 'LastName': 'Ning', 'Affiliation': 'Department of Pain, Drum Tower Hospital, Medical School of Nanjing University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Department of Pain, Drum Tower Hospital, Medical School of Nanjing University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Xinxing', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Pain Medicine, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Yuhua', 'Initials': 'Y', 'LastName': 'Chang', 'Affiliation': ""Department of Pain, Bayingolin Mongolian Autonomous Prefecture People's Hospital, Xinjiang, China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Mao', 'Affiliation': 'Department of Pain Medicine, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Pain, Drum Tower Hospital, Medical School of Nanjing University, Nanjing, Jiangsu, China.'}]",The Korean journal of pain,['10.3344/kjp.2021.34.2.210'] 2976,33783517,Assessment of an Exhaled Breath Test Using High-Pressure Photon Ionization Time-of-Flight Mass Spectrometry to Detect Lung Cancer.,"Importance Exhaled breath is an attractive option for cancer detection. A sensitive and reliable breath test has the potential to greatly facilitate diagnoses and therapeutic monitoring of lung cancer. Objective To investigate whether the breath test is able to detect lung cancer using the highly sensitive high-pressure photon ionization time-of-flight mass spectrometry (HPPI-TOFMS). Design, Setting, and Participants This diagnostic study was conducted with a prospective-specimen collection, retrospective-blinded evaluation design. Exhaled breath samples were collected before surgery and detected by HPPI-TOFMS. The detection model was constructed by support vector machine (SVM) algorithm. Patients with pathologically confirmed lung cancer were recruited from Peking University People's Hospital, and healthy adults without pulmonary noncalcified nodules were recruited from Aerospace 731 Hospital. Data analysis was performed from August to October 2020. Exposures Breath testing and SVM algorithm. Main Outcomes and Measures The detection performance of the breath test was measured by sensitivity, specificity, accuracy, and area under the receiver-operating characteristic curve (AUC). Results Exhaled breath samples were from 139 patients with lung cancer and 289 healthy adults, and all breath samples were collected and tested. Of all participants, 228 (53.27%) were women and the mean (SD) age was 57.0 (11.4) years. After clinical outcomes were ascertained, all participants were randomly assigned into the discovery data set (381 participants) and the blinded validation data set (47 participants). The discovery data set was further broken into a training set (286 participants) and a test set (95 participants) to construct and test the detection model. The detection model reached a mean (SD) of 92.97% (4.64%) for sensitivity, 96.68% (2.21%) for specificity, and 95.51% (1.93%) for accuracy in the test set after 500 iterations. In the blinded validation data set (47 participants), the model revealed a sensitivity of 100%, a specificity of 92.86%, an accuracy of 95.74%, and an AUC of 0.9586. Conclusions and Relevance This diagnostic study's results suggest that a breath test with HPPI-TOFMS is feasible and accurate for lung cancer detection, which may be useful for future lung cancer screenings.",2021,"In the blinded validation data set (47 participants), the model revealed a sensitivity of 100%, a specificity of 92.86%, an accuracy of 95.74%, and an AUC of 0.9586. Conclusions and Relevance This diagnostic study's results suggest that a breath test with HPPI-TOFMS is feasible and accurate for lung cancer detection, which may be useful for future lung cancer screenings.","[""Patients with pathologically confirmed lung cancer were recruited from Peking University People's Hospital, and healthy adults without pulmonary noncalcified nodules were recruited from Aerospace 731 Hospital"", '139 patients with lung cancer and 289 healthy adults', 'Of all participants, 228 (53.27%) were women and the mean (SD) age was 57.0 (11.4) years']",[],"['sensitivity, specificity, accuracy, and area under the receiver-operating characteristic curve (AUC', 'Exhaled breath samples']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0028259', 'cui_str': 'Nodule'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517533', 'cui_str': '11.4'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0225387', 'cui_str': 'Exhaled air'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",139.0,0.49454,"In the blinded validation data set (47 participants), the model revealed a sensitivity of 100%, a specificity of 92.86%, an accuracy of 95.74%, and an AUC of 0.9586. Conclusions and Relevance This diagnostic study's results suggest that a breath test with HPPI-TOFMS is feasible and accurate for lung cancer detection, which may be useful for future lung cancer screenings.","[{'ForeName': 'Shushi', 'Initials': 'S', 'LastName': 'Meng', 'Affiliation': ""Department of Thoracic Surgery, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Qingyun', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Shenzhen Breatha Biological Technology Co Ltd, Shenzhen, China.'}, {'ForeName': 'Zuli', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': ""Department of Thoracic Surgery, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Shenzhen Breatha Biological Technology Co Ltd, Shenzhen, China.'}, {'ForeName': 'Xianping', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Thoracic Surgery, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Shuli', 'Initials': 'S', 'LastName': 'Pan', 'Affiliation': 'Medical Examination Center, Aerospace 731 Hospital, Beijing, China.'}, {'ForeName': 'Mingru', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, Aerospace 731 Hospital, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Shenzhen Breatha Biological Technology Co Ltd, Shenzhen, China.'}, {'ForeName': 'Yanqing', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Medical Examination Center, Aerospace 731 Hospital, Beijing, China.'}, {'ForeName': 'Mantang', 'Initials': 'M', 'LastName': 'Qiu', 'Affiliation': ""Department of Thoracic Surgery, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Thoracic Surgery, Peking University People's Hospital, Beijing, China.""}]",JAMA network open,['10.1001/jamanetworkopen.2021.3486'] 2977,33792551,Text Messaging Intervention for Young Smokers Experiencing Homelessness: Lessons Learned From a Randomized Controlled Trial.,"BACKGROUND Smoking rates are significantly higher among young people experiencing homelessness than in the general population. Despite a willingness to quit, homeless youth have little success in doing so on their own, and existing cessation resources tailored to this population are lacking. Homeless youth generally enjoy the camaraderie and peer support that group-based programs offer, but continuous in-person support during a quit attempt can be prohibitively expensive. OBJECTIVE This study aimed to assess the feasibility and acceptability of an automated text messaging intervention (TMI) as an adjunct to group-based cessation counseling and provision of nicotine patches to help homeless youth quit smoking. This paper outlines the lessons learned from the implementation of the TMI intervention. METHODS Homeless youth smokers aged 18 to 25 years who were interested in quitting (n=77) were recruited from drop-in centers serving homeless youth in the Los Angeles area. In this pilot randomized controlled trial, all participants received a group-based cessation counseling session and nicotine patches, with 52% (40/77) randomly assigned to receive 6 weeks of text messages to provide additional support for their quit attempt. Participants received text messages on their own phone rather than receiving a study-issued phone for the TMI. We analyzed baseline and follow-up survey data as well as back-end data from the messaging platform to gauge the acceptability and feasibility of the TMI among the 40 participants who received it. RESULTS Participants had widespread (smart)phone ownership-16.4% (36/219) were ineligible for study participation because they did not have a phone that could receive text messages. Participants experienced interruptions in their phone use (eg, 44% [16/36] changed phone numbers during the follow-up period) but reported being able to receive the majority of messages. These survey results were corroborated by back-end data (from the program used to administer the TMI) showing a message delivery rate of about 95%. Participant feedback points to the importance of carefully crafting text messages, which led to high (typically above 70%) approval of most text messaging components of the intervention. Qualitative feedback indicated that participants enjoyed the group counseling session that preceded the TMI and suggested including more such group elements into the intervention. CONCLUSIONS The TMI was well accepted and feasible to support smoking cessation among homeless youth. Given high rates of smartphone ownership, the next generation of phone-based smoking cessation interventions for this population should consider using approaches beyond text messages and focus on finding ways to develop effective approaches to include group interaction using remote implementation. Given overall resource constraints and in particular the exigencies of the currently ongoing COVID-19 epidemic, phone-based interventions are a promising approach to support homeless youth, a population urgently in need of effective smoking cessation interventions. TRIAL REGISTRATION ClinicalTrials.gov NCT03874585; https://clinicaltrials.gov/ct2/show/NCT03874585. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) RR2-10.1186/s13722-020-00187-6.",2021,"RESULTS Participants had widespread (smart)phone ownership-16.4% (36/219) were ineligible for study participation because they did not have a phone that could receive text messages.","['40 participants who received it', 'homeless youth', 'homeless youth quit smoking', 'Participants had widespread (smart)phone ownership-16.4% (36/219) were ineligible for study participation', 'Young Smokers Experiencing Homelessness', 'Homeless youth', 'Homeless youth smokers aged 18 to 25 years who were interested in quitting (n=77) were recruited from drop-in centers serving homeless youth in the Los Angeles area']","['nicotine patches', 'text messages on their own phone rather than receiving a study-issued phone for the TMI', 'automated text messaging intervention (TMI', 'Text Messaging Intervention', 'group-based cessation counseling session and nicotine patches']",['feasibility and acceptability'],"[{'cui': 'C0242663', 'cui_str': 'Homeless Children'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0205219', 'cui_str': 'Diffuse'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0029981', 'cui_str': 'Ownership'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.139816,"RESULTS Participants had widespread (smart)phone ownership-16.4% (36/219) were ineligible for study participation because they did not have a phone that could receive text messages.","[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Linnemayr', 'Affiliation': 'RAND Corporation, Santa Monica, CA, United States.'}, {'ForeName': 'Rushil', 'Initials': 'R', 'LastName': 'Zutshi', 'Affiliation': 'RAND Corporation, Santa Monica, CA, United States.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Shadel', 'Affiliation': 'RAND Corporation, Pittsburgh, PA, United States.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Pedersen', 'Affiliation': 'University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'DeYoreo', 'Affiliation': 'RAND Corporation, Santa Monica, CA, United States.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Tucker', 'Affiliation': 'RAND Corporation, Santa Monica, CA, United States.'}]",JMIR mHealth and uHealth,['10.2196/23989'] 2978,33792210,Effects of non-surgical periodontal treatment in rheumatoid arthritis patients: A randomized clinical trial.,"BACKGROUND The periodontal condition has a reciprocal relationship with rheumatoid arthritis (RA). Rheumatoid arthritis patients are reported to present with more serious periodontal disease (PD) as compared to non-RA patients. OBJECTIVES This study aimed to evaluate the effects of non-surgical periodontal treatment on Vietnamese patients with active RA and PD, where the clinical characteristics and serum indices of the patients were of interest. MATERIAL AND METHODS We conducted a randomized clinical trial (RCT) on 82 RA patients with PD. The patients were randomly divided into 2 groups: the intervention group, consisting of patients who received oral hygiene instructions, scaling and root planing; and the control group, consisting of patients who received oral hygiene instructions only. Both groups received the same treatment plan for RA. The Disease Activity Score 28 based on C-reactive protein (DAS28-CRP), disease activity classification, rheumatoid factor (RF), erythrocyte sedimentation rate (ESR), anti-citrullinated protein autoantibodies (ACPAs), and C-reactive protein (CRP) were monitored, with the measurements taken at 3 months and 6 months following the treatment. RESULTS The 2 groups exhibited similar parameters at baseline. In the intervention group, DAS28-CRP and disease activity classification were significantly reduced at 3 months after treatment as compared to the baseline data. At 6 months following the treatment there was a significant decrease in ESR, ACPAs and DAS28-CRP in the intervention group, while the control group showed a decrease only in ACPAs. Further, when comparing the intervention and control groups at 6 months following the treatment, there were no differences between the groups in the ACPAs, RF and CRP serum levels. CONCLUSIONS Non-surgical periodontal treatment can significantly reduce DAS28-CRP, disease activity classification, ESR, and the ACPAs level in serum, and can be applied to reduce RA severity in RA patients with PD.",2021,"At 6 months following the treatment there was a significant decrease in ESR, ACPAs and DAS28-CRP in the intervention group, while the control group showed a decrease only in ACPAs.","['82 RA patients with PD', 'Rheumatoid arthritis patients', 'RA patients with PD', 'rheumatoid arthritis patients', 'Vietnamese patients with active RA and PD']","['non-surgical periodontal treatment', 'oral hygiene instructions, scaling and root planing; and the control group, consisting of patients who received oral hygiene instructions only']","['Disease Activity Score 28 based on C-reactive protein (DAS28-CRP), disease activity classification, rheumatoid factor (RF), erythrocyte sedimentation rate (ESR), anti-citrullinated protein autoantibodies (ACPAs), and C-reactive protein (CRP', 'DAS28-CRP, disease activity classification, ESR, and the ACPAs level', 'RA severity', 'DAS28-CRP and disease activity classification', 'ACPAs, RF and CRP serum levels', 'ESR, ACPAs and DAS28-CRP', 'ACPAs']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031090', 'cui_str': 'Periodontal disease'}, {'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0204131', 'cui_str': 'Oral hygiene education'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0035448', 'cui_str': 'Rheumatoid factor'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0004358', 'cui_str': 'Autoantibody'}, {'cui': 'C1272321', 'cui_str': 'Autoantibody measurement'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",82.0,0.0714186,"At 6 months following the treatment there was a significant decrease in ESR, ACPAs and DAS28-CRP in the intervention group, while the control group showed a decrease only in ACPAs.","[{'ForeName': 'Van Bich', 'Initials': 'VB', 'LastName': 'Nguyen', 'Affiliation': 'Department of Periodontology, Faculty of Odonto-Stomatology, University of Medicine and Pharmacy at Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Thuy Thu', 'Initials': 'TT', 'LastName': 'Nguyen', 'Affiliation': 'Department of Periodontology, Faculty of Odonto-Stomatology, University of Medicine and Pharmacy at Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nam Cong-Nhat', 'Initials': 'NC', 'LastName': 'Huynh', 'Affiliation': 'Department of Dental Basic Sciences, Faculty of Odonto-Stomatology, University of Medicine and Pharmacy at Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Khoa Dinh', 'Initials': 'KD', 'LastName': 'Nguyen', 'Affiliation': 'Department of Rheumatology, Cho Ray Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Thu Anh', 'Initials': 'TA', 'LastName': 'Le', 'Affiliation': 'Faculty of Medicine, Vo Truong Toan University, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Hung Tu', 'Initials': 'HT', 'LastName': 'Hoang', 'Affiliation': 'Faculty of Medicine, Vietnam National University - Ho Chi Minh City, Vietnam.'}]",Dental and medical problems,['10.17219/dmp/131266'] 2979,33792019,[Effects of Motivational Interview and Mobile Social Network Support on Smoking Cessation in Male Patients With Coronary Heart Disease].,"BACKGROUND Patients with coronary heart disease (CHD) who quit smoking exhibit lower rates of heart attack recurrence and mortality than their peers who continue smoking. However, most male patients with CHD resume smoking after hospital discharge. PURPOSE To explore the effectiveness of motivational interventions and mobile social network support on smoking cessation and other predictors of smoking cessation in male patients with CHD. METHODS An experimental design was used, and a convenience sample was recruited from a cardiology ward of a hospital in northern Taiwan. The participants were randomly assigned to the experimental group (n = 57) and control group (n = 64). During hospitalization, each participant completed a questionnaire after undergoing cardiac catheterization. The questionnaire included a demographic datasheet, the Fagerström Test for Nicotine Dependence, and the contemplation ladder. Afterward, the experimental group received motivational interventions, filled out a self-efficacy scale and the contemplation ladder, and joined an online mobile social group (LINE) for three months. The control group received regular care and a smoking cessation booklet, and then filled out the self-efficacy scale and contemplation ladder. An intention-to-treat analysis was adopted to evaluate smoke cessation status. Information on post-discharge smoking status was collected from the participants via the Line communications app or phone calls at three-months after hospital discharge and was further confirmed using urinary cotinine levels. RESULTS The results revealed that both groups registered improvements in motivation to quit smoking. This motivation was relatively higher in the experimental group after the intervention than in the control group. The smoking cessation rate in the experimental group (35.09%) was higher than that in the control group (17.19%). However, the intergroup difference in the cessation rate only approached statistical significance (OR: 2.34; p = .055) after controlling for the baseline difference between the two groups. Controlling for the effects of the intervention, age of smoking initiation, first diagnosis of CHD, and self-efficacy were identified as predictors of smoking cessation. CONCLUSIONS / IMPLICATIONS FOR PRACTICE Healthcare providers are encouraged to provide motivational interviews to enhance the motivation of their patients to quit smoking as well as to incorporate self-efficacy into related interventions to increase the smoking cessation rate.",2021,"However, the intergroup difference in the cessation rate only approached statistical significance (OR: 2.34","['male patients with CHD resume smoking after hospital discharge.\nPURPOSE', 'male patients with CHD', 'Patients with coronary heart disease (CHD', 'convenience sample was recruited from a cardiology ward of a hospital in northern Taiwan', 'Male Patients With Coronary Heart Disease']","['motivational interventions and mobile social network support', 'Motivational Interview and Mobile Social Network Support', 'motivational interventions, filled out a self-efficacy scale and the contemplation ladder, and joined an online mobile social group (LINE', 'regular care and a smoking cessation booklet']","['heart attack recurrence and mortality', 'motivation to quit smoking', 'smoking cessation rate', 'cessation rate', 'Smoking Cessation']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0336762', 'cui_str': 'Ladder'}, {'cui': 'C0687744', 'cui_str': 'Social group'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]",64.0,0.0149879,"However, the intergroup difference in the cessation rate only approached statistical significance (OR: 2.34","[{'ForeName': 'Yi-Hsuan', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': 'MSN, RN, Supervisor, Department of Nursing, Taipei Tzu Chi Hospital, Taiwan, ROC.'}, {'ForeName': 'Peng-Chih', 'Initials': 'PC', 'LastName': 'Wang', 'Affiliation': 'PhD, Associate Professor, Department of Clinical Psychology, Fu-Jen Catholic University, Taiwan, ROC.'}, {'ForeName': 'Yu-Lin', 'Initials': 'YL', 'LastName': 'Ko', 'Affiliation': 'PhD, Professor, Department of Internal Medicine, Tzu Chi University, Taiwan, ROC.'}, {'ForeName': 'Huey-Ling', 'Initials': 'HL', 'LastName': 'Wang', 'Affiliation': 'PhD, RN, Associate Professor, Department of Nursing, Fu-Jen Catholic University, Taiwan, ROC. 033550@mail.fju.edu.tw.'}]",Hu li za zhi The journal of nursing,['10.6224/JN.202104_68(2).08'] 2980,33238818,Comparison of the Effects of Coaching for General and Special Education Teachers in High-Poverty Urban Elementary Schools.,"Research that examines coaching approaches for special education teachers is very limited. This study, a secondary analysis of a wait-list controlled, randomized trial (106 teachers, 2,195 students, 18 schools), investigated the effects of a data-driven coaching that integrated observational assessment and performance feedback on general education (GE) versus special education (SE) teacher practices and student outcomes in high-poverty urban elementary schools. Coaches used observational data via the Classroom Strategies Assessment System to identify practice needs, set goals, create plans, and monitor progress toward goals. Prior to coaching, GE and SE teachers were observed using evidence-based instructional and behavior management practices; however, some practices were at rates lower than recommended by the research literature. Results suggest that goal selection and frequency and quality of practices were generally comparable between GE and SE teachers. However, SE teachers used 30% fewer behavior corrective feedback statements, on average, than GE teachers ( p = .04). Overall, the effect of the coaching intervention did not differ across GE and SE teachers; both had significantly improved instructional and behavior management practices and student outcomes when compared with teachers in the control condition. Limitations and future directions for research and practice are discussed.",2021,"However, SE teachers used 30% fewer behavior corrective feedback statements, on average, than GE teachers ( p = .04).","['high-poverty urban elementary schools', 'special education teachers', '106 teachers, 2,195 students, 18 schools', 'High-Poverty Urban Elementary Schools']","['data-driven coaching that integrated observational assessment and performance feedback on general education (GE) versus special education (SE) teacher practices', 'coaching intervention', 'Coaching for General and Special Education Teachers']","['behavior corrective feedback statements', 'goal selection and frequency and quality of practices']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0221458', 'cui_str': 'Special education teacher'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0588388', 'cui_str': 'General observation'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0013649', 'cui_str': 'Special Education'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0221458', 'cui_str': 'Special education teacher'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",106.0,0.0234738,"However, SE teachers used 30% fewer behavior corrective feedback statements, on average, than GE teachers ( p = .04).","[{'ForeName': 'Linda A', 'Initials': 'LA', 'LastName': 'Reddy', 'Affiliation': 'Rutgers University, Piscataway, NJ, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Lekwa', 'Affiliation': 'Rutgers University, Piscataway, NJ, USA.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Shernoff', 'Affiliation': 'Rutgers University, Piscataway, NJ, USA.'}]",Journal of learning disabilities,['10.1177/0022219420970194'] 2981,33245288,"Testing the Efficacy of a Multicomponent, Self-Guided, Smartphone-Based Meditation App: Three-Armed Randomized Controlled Trial.","BACKGROUND A growing number of randomized controlled trials (RCTs) suggest psychological benefits associated with meditation training delivered via mobile health. However, research in this area has primarily focused on mindfulness, only one of many meditative techniques. OBJECTIVE This study aims to evaluate the efficacy of 2 versions of a self-guided, smartphone-based meditation app-the Healthy Minds Program (HMP)-which includes training in mindfulness (Awareness), along with practices designed to cultivate positive relationships (Connection) or insight into the nature of the self (Insight). METHODS A three-arm, fully remote RCT compared 8 weeks of one of 2 HMP conditions (Awareness+Connection and Awareness+Insight) with a waitlist control. Adults (≥18 years) without extensive previous meditation experience were eligible. The primary outcome was psychological distress (depression, anxiety, and stress). Secondary outcomes were social connection, empathy, compassion, self-reflection, insight, rumination, defusion, and mindfulness. Measures were completed at pretest, midtreatment, and posttest between October 2019 and April 2020. Longitudinal data were analyzed using intention-to-treat principles with maximum likelihood. RESULTS A total of 343 participants were randomized and 186 (54.2%) completed at least one posttest assessment. The majority (166/228, 72.8%) of those assigned to HMP conditions downloaded the app. The 2 HMP conditions did not differ from one another in terms of changes in any outcome. Relative to the waitlist control, the HMP conditions showed larger improvements in distress, social connectedness, mindfulness, and measures theoretically linked to insight training (d=-0.28 to 0.41; Ps≤.02), despite modest exposure to connection- and insight-related practice. The results were robust to some assumptions about nonrandom patterns of missing data. Improvements in distress were associated with days of use. Candidate mediators (social connection, insight, rumination, defusion, and mindfulness) and moderators (baseline rumination, defusion, and empathy) of changes in distress were identified. CONCLUSIONS This study provides initial evidence of efficacy for the HMP app in reducing distress and improving outcomes related to well-being, including social connectedness. Future studies should attempt to increase study retention and user engagement. TRIAL REGISTRATION ClinicalTrials.gov NCT04139005; https://clinicaltrials.gov/ct2/show/NCT04139005.",2020,"This study provides initial evidence of efficacy for the HMP app in reducing distress and improving outcomes related to well-being, including social connectedness.","['Adults (≥18 years) without extensive previous meditation experience were eligible', 'A total of 343 participants were randomized and 186 (54.2%) completed at least one posttest assessment']","['Multicomponent, Self-Guided, Smartphone-Based Meditation App', 'self-guided, smartphone-based meditation app-the Healthy Minds Program (HMP)-which includes training in mindfulness (Awareness', 'HMP']","['social connection, empathy, compassion, self-reflection, insight, rumination, defusion, and mindfulness', 'psychological distress (depression, anxiety, and stress', 'distress', 'Candidate mediators (social connection, insight, rumination, defusion, and mindfulness) and moderators (baseline rumination, defusion, and empathy) of changes in distress', 'distress, social connectedness, mindfulness, and measures theoretically linked to insight training']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517808', 'cui_str': '54.2'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]","[{'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0233820', 'cui_str': 'Insight'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",343.0,0.0982615,"This study provides initial evidence of efficacy for the HMP app in reducing distress and improving outcomes related to well-being, including social connectedness.","[{'ForeName': 'Simon B', 'Initials': 'SB', 'LastName': 'Goldberg', 'Affiliation': 'Center for Healthy Minds, University of Wisconsin, Madison, WI, United States.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Imhoff-Smith', 'Affiliation': 'Center for Healthy Minds, University of Wisconsin, Madison, WI, United States.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Bolt', 'Affiliation': 'Department of Educational Psychology, University of Wisconsin-Madison, Madison, WI, United States.'}, {'ForeName': 'Christine D', 'Initials': 'CD', 'LastName': 'Wilson-Mendenhall', 'Affiliation': 'Center for Healthy Minds, University of Wisconsin, Madison, WI, United States.'}, {'ForeName': 'Cortland J', 'Initials': 'CJ', 'LastName': 'Dahl', 'Affiliation': 'Center for Healthy Minds, University of Wisconsin, Madison, WI, United States.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Davidson', 'Affiliation': 'Center for Healthy Minds, University of Wisconsin, Madison, WI, United States.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Rosenkranz', 'Affiliation': 'Center for Healthy Minds, University of Wisconsin, Madison, WI, United States.'}]",JMIR mental health,['10.2196/23825'] 2982,33243042,Venous sinus stenting for the treatment of isolated pulsatile tinnitus: Results of a prospective trial.,"OBJECTIVES This prospective study evaluates the effectiveness and safety of venous sinus stenting for patients with isolated pulsatile tinnitus and lateral sinus stenosis. METHODS Patients with isolated pulsatile tinnitus and lateral sinus stenosis with a minimum trans stenotic gradient of 4 mm Hg were treated with stenting. Pulsatile tinnitus before and after treatment was assessed with the Tinnitus Handicap Inventory (THI). Periprocedural adverse events, neurological complications, clinical and radiographic follow-up were also recorded. RESULTS A total of 42 patients (41 females and 1 male) were included in the study (median age of 37.5 years). Thirty patients had post-stenotic fusiform and 12 had post-stenotic saccular venous sinus aneurysm. In addition to stenting, coils were used to treat the patients with saccular venous aneurysms. The median follow-up was 5 months (range 1 to 34 months). Most patients had complete (39/42) or near-complete (2/42) resolution of their pulsatile tinnitus post-procedure. There were no serious adverse events. CONCLUSION Stenting of the lateral venous sinus is a safe and effective treatment for patients with isolated pulsatile tinnitus due to venous sinus stenosis.",2021,Stenting of the lateral venous sinus is a safe and effective treatment for patients with isolated pulsatile tinnitus due to venous sinus stenosis.,"['patients with saccular venous aneurysms', 'Patients with isolated pulsatile tinnitus and lateral sinus stenosis with a minimum trans stenotic gradient of 4\u2009mm Hg were treated with', 'patients with isolated pulsatile tinnitus and lateral sinus stenosis', '42 patients (41 females and 1 male) were included in the study (median age of 37.5\u2009years', 'Thirty patients had post-stenotic fusiform and 12 had post-stenotic saccular venous sinus aneurysm', 'isolated pulsatile tinnitus', 'patients with isolated pulsatile tinnitus due to venous sinus stenosis']","['stenting', 'Venous sinus stenting', 'venous sinus stenting']","['Pulsatile tinnitus', 'Periprocedural adverse events, neurological complications, clinical and radiographic follow-up', 'Tinnitus Handicap Inventory (THI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205137', 'cui_str': 'Saccular'}, {'cui': 'C0948017', 'cui_str': 'Venous aneurysm'}, {'cui': 'C0751559', 'cui_str': 'Pulsatile Tinnitus'}, {'cui': 'C0226864', 'cui_str': 'Structure of transverse sinus'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0333181', 'cui_str': 'Stenosed'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517742', 'cui_str': '37.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332493', 'cui_str': 'Fusiform shape'}, {'cui': 'C0226504', 'cui_str': 'Structure of venous sinus'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0226504', 'cui_str': 'Structure of venous sinus'}]","[{'cui': 'C0751559', 'cui_str': 'Pulsatile Tinnitus'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",42.0,0.0203477,Stenting of the lateral venous sinus is a safe and effective treatment for patients with isolated pulsatile tinnitus due to venous sinus stenosis.,"[{'ForeName': 'Athos', 'Initials': 'A', 'LastName': 'Patsalides', 'Affiliation': 'Division of Interventional Neuroradiology, Department of Neurosurgery, New York Presbyterian Hospital/Weill Cornell Medical Center, New York, NY, USA.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Santillan', 'Affiliation': 'Division of Interventional Neuroradiology, Department of Neurosurgery, New York Presbyterian Hospital/Weill Cornell Medical Center, New York, NY, USA.'}, {'ForeName': 'Sri Hari', 'Initials': 'SH', 'LastName': 'Sundararajan', 'Affiliation': 'Division of Interventional Neuroradiology, Department of Neurosurgery, New York Presbyterian Hospital/Weill Cornell Medical Center, New York, NY, USA.'}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Michael', 'Affiliation': 'Division of Interventional Neuroradiology, Department of Neurosurgery, New York Presbyterian Hospital/Weill Cornell Medical Center, New York, NY, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Suurna', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, New York Presbyterian Hospital/Weill Cornell Medical Center, New York, NY, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Alexiades', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, New York Presbyterian Hospital/Weill Cornell Medical Center, New York, NY, USA.'}]","Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences",['10.1177/1591019920974185'] 2983,33244709,Preterm infants with severe brain injury demonstrate unstable physiological responses during maternal singing with music therapy: a randomized controlled study.,"Preterm infants with severe brain injury are at high risk for poor outcomes and, therefore, may benefit from developmental care modalities such as music therapy (MT). In this prospective, randomized intervention, preterm infants with severe brain injury (grade 3 or 4 intraventricular hemorrhage or periventricular leukomalacia) who underwent skin-to-skin contact (SSC) with or without maternal singing during MT were evaluated for physiological responses, including autonomic nervous system stability (low frequency (LF)/high frequency (HF) power), heart rate, respiratory rate, oxygen saturation, and behavioral state. Maternal anxiety state and physiological data were also evaluated. A total of 35 preterm infants with severe brain injuries were included in the study analysis. Higher mean ± standard deviation (SD) LF/HF ratio (1.8 ± 0.7 vs. 1.1 ± 0.25, p = 0.01), higher mean ± SD heart rate (145 ± 15 vs. 132 ± 12 beats per minute, p = 0.04), higher median (interquartile range) infant behavioral state (NIDCAP manual for naturalistic observation and the Brazelton Neonatal Behavioral Assessment) score (3 (2-5) vs. 1 (1-3), p = 0.03), and higher mean ± SD maternal anxiety (state-trait anxiety inventory) score (39.1 ± 10.4 vs. 31.5 ± 7.3, p = 0.04) were documented in SSC combined with maternal singing during MT, as compared to SSC alone.Conclusion: Maternal singing during MT for preterm infants with severe brain injury induces physiological and behavioral instability and increases maternal anxiety during NICU hospitalization. A unique MT intervention should be designed for preterm infants with severe brain injury and their mothers. What is Known: • Preterm infants with severe brain injury are at high risk for poor outcomes. • Music therapy benefits brain development of preterm infants without severe brain injury, however it is unknown whether maternal singing during music therapy for preterm infants with severe brain injury is beneficial. What is New: • Maternal singing during music therapy for preterm infants with severe brain injury induces physiological and behavioral instability and increases maternal anxiety during NICU hospitalization. • A unique music therapy intervention should be designed for preterm infants with severe brain injury and their mothers.",2021,Maternal singing during MT for preterm infants with severe brain injury induces physiological and behavioral instability and increases maternal anxiety during NICU hospitalization.,"['preterm infants without severe brain injury', 'preterm infants with severe brain injury and their mothers', 'preterm infants with severe brain injury', 'preterm infants with severe brain injury (grade 3 or 4 intraventricular hemorrhage or periventricular leukomalacia) who underwent', 'Preterm infants with severe brain injury', '35 preterm infants with severe brain injuries']","['MT intervention', 'skin-to-skin contact (SSC) with or without maternal singing during MT', 'maternal singing with music therapy', 'Music therapy', 'music therapy intervention']","['maternal anxiety', 'higher mean ± SD heart rate', 'Maternal singing', 'infant behavioral state (NIDCAP manual for naturalistic observation and the Brazelton Neonatal Behavioral Assessment) score', 'Higher mean ± standard deviation (SD) LF/HF ratio', 'physiological responses, including autonomic nervous system stability (low frequency (LF)/high frequency (HF) power), heart rate, respiratory rate, oxygen saturation, and behavioral state', 'Maternal anxiety state and physiological data', 'higher mean ± SD maternal anxiety (state-trait anxiety inventory) score']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0023529', 'cui_str': 'Periventricular leukomalacia'}]","[{'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1160858', 'cui_str': 'Behavior assessment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}]",35.0,0.170524,Maternal singing during MT for preterm infants with severe brain injury induces physiological and behavioral instability and increases maternal anxiety during NICU hospitalization.,"[{'ForeName': 'Shulamit', 'Initials': 'S', 'LastName': 'Epstein', 'Affiliation': 'School of Creative Arts Therapies, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Bauer', 'Affiliation': 'Department of Neonatology, Meir Medical Center, 59 Tchernichovsky St., 44281, Kfar Saba, Israel.'}, {'ForeName': 'Orly', 'Initials': 'O', 'LastName': 'Levkovitz Stern', 'Affiliation': 'Department of Neonatology, Meir Medical Center, 59 Tchernichovsky St., 44281, Kfar Saba, Israel.'}, {'ForeName': 'Ita', 'Initials': 'I', 'LastName': 'Litmanovitz', 'Affiliation': 'Department of Neonatology, Meir Medical Center, 59 Tchernichovsky St., 44281, Kfar Saba, Israel.'}, {'ForeName': 'Cochavit', 'Initials': 'C', 'LastName': 'Elefant', 'Affiliation': 'School of Creative Arts Therapies, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Yakobson', 'Affiliation': 'Department of Neonatology, Meir Medical Center, 59 Tchernichovsky St., 44281, Kfar Saba, Israel.'}, {'ForeName': 'Shmuel', 'Initials': 'S', 'LastName': 'Arnon', 'Affiliation': 'Department of Neonatology, Meir Medical Center, 59 Tchernichovsky St., 44281, Kfar Saba, Israel. harnon@netvision.net.il.'}]",European journal of pediatrics,['10.1007/s00431-020-03890-3'] 2984,33247001,Randomised controlled trial of an augmented exercise referral scheme using web-based behavioural support for inactive adults with chronic health conditions: the e-coachER trial.,"OBJECTIVE To determine whether adding web-based support (e-coachER) to an exercise referral scheme (ERS) increases objectively assessed physical activity (PA). DESIGN Multicentre trial with participants randomised to usual ERS alone (control) or usual ERS plus e-coachER (intervention). SETTING Primary care and ERS in three UK sites from 2015 to 2018. PARTICIPANTS 450 inactive ERS referees with chronic health conditions. INTERVENTIONS Participants received a pedometer, PA recording sheets and a user guide for the web-based support. e-coachER interactively encouraged the use of the ERS and other PA options. MAIN OUTCOME MEASURES Primary and key secondary outcomes were: objective moderate-to-vigorous PA (MVPA) minutes (in ≥10 min bouts and without bouts), respectively, after 12 months. Secondary outcomes were: other accelerometer-derived and self-reported PA measures, ERS attendance, EQ-5D-5L, Hospital Anxiety and Depression Scale and beliefs about PA. All outcomes were collected at baseline, 4 and 12 months. Primary analysis was an intention to treat comparison between intervention and control arms at 12-month follow-up. RESULTS There was no significant effect of the intervention on weekly MVPA at 12 months between the groups recorded in ≥10 min bouts (mean difference 11.8 min of MVPA, 95% CI: -2.1 to 26.0; p=0.10) or without bouts (mean difference 13.7 min of MVPA, 95% CI: -26.8 to 54.2; p=0.51) for 232 participants with usable data. There was no difference in the primary or secondary PA outcomes at 4 or 12 months. CONCLUSION Augmenting ERS referrals with web-based behavioural support had only a weak, non-significant effect on MVPA. TRIAL REGISTRATION NUMBER ISRCTN15644451.",2021,"There was no significant effect of the intervention on weekly MVPA at 12 months between the groups recorded in ≥10 min bouts (mean difference 11.8 min of MVPA, 95% CI: -2.1 to 26.0; p=0.10) or without bouts (mean difference 13.7 min of MVPA, 95% CI: -26.8 to 54.2; p=0.51) for 232 participants with usable data.","['232 participants with usable data', 'Primary care and ERS in three UK sites from 2015 to 2018', 'inactive adults with chronic health conditions', '450 inactive ERS referees with chronic health conditions']","['augmented exercise referral scheme using web-based behavioural support', 'pedometer, PA recording sheets and a user guide for the web-based support', 'adding web-based support (e-coachER) to an exercise referral scheme (ERS', 'usual ERS alone (control) or usual ERS plus e-coachER (intervention']","['other accelerometer-derived and self-reported PA measures, ERS attendance, EQ-5D-5L, Hospital Anxiety and Depression Scale and beliefs about PA', 'objective moderate-to-vigorous PA (MVPA) minutes (in ≥10\u2009min bouts and without bouts', 'physical activity (PA', 'weekly MVPA']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C3844104', 'cui_str': '450'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0439643', 'cui_str': 'Sheets'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]",232.0,0.197704,"There was no significant effect of the intervention on weekly MVPA at 12 months between the groups recorded in ≥10 min bouts (mean difference 11.8 min of MVPA, 95% CI: -2.1 to 26.0; p=0.10) or without bouts (mean difference 13.7 min of MVPA, 95% CI: -26.8 to 54.2; p=0.51) for 232 participants with usable data.","[{'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Taylor', 'Affiliation': 'Peninsula School of Medicine, Faculty of Health, University of Plymouth, Plymouth, Devon, UK adrian.taylor@plymouth.ac.uk.'}, {'ForeName': 'Rod S', 'Initials': 'RS', 'LastName': 'Taylor', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Ingram', 'Affiliation': 'Peninsula Clinical Trials Unit, University of Plymouth, Plymouth, Devon, UK.'}, {'ForeName': 'Sarah Gerard', 'Initials': 'SG', 'LastName': 'Dean', 'Affiliation': 'University of Exeter Medical School, Exeter, Devon, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jolly', 'Affiliation': 'Public Health, Epidemiology and Biostatistics, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Nanette', 'Initials': 'N', 'LastName': 'Mutrie', 'Affiliation': 'Physical Activity for Health Research Centre, The University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Lambert', 'Affiliation': 'Department of Health, University of Bath, Bath, Somerset, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Yardley', 'Affiliation': 'Public Health, Epidemiology and Biostatistics, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Streeter', 'Affiliation': 'Medical Statistics, University of Plymouth, Plymouth, Devon, UK.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Greaves', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'McAdam', 'Affiliation': 'Physical Activity for Health Research Centre, The University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Price', 'Affiliation': 'School of Sport and Health Sciences, University of Exeter, Exeter, Devon, UK.'}, {'ForeName': 'Nana Kwame', 'Initials': 'NK', 'LastName': 'Anokye', 'Affiliation': 'Department of Clinical Sciences, Brunel University, Uxbridge, Middlesex, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Campbell', 'Affiliation': 'University of Exeter Medical School, Exeter, Devon, UK.'}]",British journal of sports medicine,['10.1136/bjsports-2020-103121'] 2985,33247023,"Mental health of Urban Mothers (MUM) study: a multicentre randomised controlled trial, study protocol.","INTRODUCTION Mental health disorders are common during pregnancy and the postnatal period and can have serious adverse effects on women and their children. The consequences for global mental health due to COVID-19 are likely to be significant and may have a long-term impact on the global burden of disease. Besides physical vulnerability, pregnant women are at increased risk of mental health problems such as anxiety, depression and post-traumatic stress disorder due to the consequences of social distancing. It can result in altered healthcare routines, less support from the family and friends, and in some cases, partners not being allowed to be present during prenatal visits, labour and delivery. Higher than expected, rates of perinatal anxiety and depression have been already reported during the pandemic. Pregnant women may also feel insecure and worried about the effects of COVID-19 on their unborn child if they get infected during pregnancy. Today, young urban women are used to using internet services frequently and efficiently. Therefore, providing mental health support to pregnant women via internet may be effective in ameliorating their anxiety/depression, reducing the risk of serious mental health disorders, and lead to improved maternal and perinatal outcomes. OVERARCHING AIM Our aim is to explore the effectiveness of a web-based psychosocial peer-to-peer support intervention in reducing the risk and severity of perinatal mental health disorders and preventing adverse pregnancy outcomes among pregnant women living in metropolitan urban settings. METHODS AND ANALYSIS We plan to conduct a multicentre prospective randomised controlled trial, Mental health of Urban Mothers trial. Pregnant women living in large metropolitan cities will be recruited using internet-based application through non-profit organisations' websites. The women who consent will be randomised to receive a web-based peer-to-peer support intervention or usual care. Data will be analysed to identify the effects of intervention on Edinburgh Postnatal Depression Score and Generalised Anxiety Disorder 7 scores as well as pregnancy outcomes. The impact of COVID-19 pandemic on maternal stress will be assesed using Impact Event Scale-R. Any differences in outcomes between cities will be addressed in subgroup analyses. ETHICS AND DISSEMINATION The study will be conducted according to the principles of Good Clinical Practice and will follow the ethical principles of the Declaration of Helsinki. The study protocol has been approved by the ethical review board of Chinese University of Hong Kong (IRB number 2019-8170) and Shanghai Center for Women's and Children's Health (international review board (IRB) number 2020-F001-12). The results will be disseminated at national and international scientific conferences, published in peer-reviewed medical journals and spread to the public through social media, news outlets and podcasts. TRIAL REGISTRATION NUMBER NCT04363177; Trial sponsor Karolinska Institute, CLINTEC, Stockholm, Sweden.",2020,Data will be analysed to identify the effects of intervention on Edinburgh Postnatal Depression Score and Generalised Anxiety Disorder 7 scores as well as pregnancy outcomes.,"['Pregnant women living in large metropolitan cities', 'Pregnant women', ""Chinese University of Hong Kong (IRB number 2019-8170) and Shanghai Center for Women's and Children's Health (international review board"", 'Mental health of Urban Mothers trial', 'pregnant women living in metropolitan urban settings', 'young urban women']","['web-based psychosocial peer-to-peer support intervention', 'web-based peer-to-peer support intervention or usual care']","['Edinburgh Postnatal Depression Score and Generalised Anxiety Disorder 7 scores', 'rates of perinatal anxiety and depression', 'adverse pregnancy outcomes']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}]",,0.145914,Data will be analysed to identify the effects of intervention on Edinburgh Postnatal Depression Score and Generalised Anxiety Disorder 7 scores as well as pregnancy outcomes.,"[{'ForeName': 'Simone Eliane', 'Initials': 'SE', 'LastName': 'Schwank', 'Affiliation': 'CLINTEC, Karolinska Institute, Stockholm, Sweden simone.schwank@ki.se.'}, {'ForeName': 'Ho-Fung', 'Initials': 'HF', 'LastName': 'Chung', 'Affiliation': 'Psychiatry, The University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Hsu', 'Affiliation': 'Psychological and Brain Sciences, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Shih-Chien', 'Initials': 'SC', 'LastName': 'Fu', 'Affiliation': 'Counseling Psychology, National Taipei University of Education, Taipei, Taiwan.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Du', 'Affiliation': 'Department of Research and Education, Tongji University, Shanghai, Shanghai, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Department of Research and Education, Tongji University, Shanghai, Shanghai, China.'}, {'ForeName': 'Hsuan-Ying', 'Initials': 'HY', 'LastName': 'Huang', 'Affiliation': 'Anthropology, The Chinese University Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Andersson', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Acharya', 'Affiliation': ""Women's Health and Perinatology Research Group, Department of Clinical Medicine, UiT-The Arctic University of Norway, Tromsø, Norway.""}]",BMJ open,['10.1136/bmjopen-2020-041133'] 2986,33255807,Ultra-Marathon-Induced Increase in Serum Levels of Vitamin D Metabolites: A Double-Blind Randomized Controlled Trial.,"PURPOSE While an increasing number of studies demonstrate the importance of vitamin D for athletic performance, the effects of any type of exercise on vitamin D metabolism are poorly characterized. We aimed to identify the responses of some vitamin D metabolites to ultra-marathon runs. METHODS A repeated-measures design was implemented, in which 27 amateur runners were assigned into two groups: those who received a single dose of vitamin D 3 (150,000 IU) 24 h before the start of the marathon ( n = 13) and those ( n = 14) who received a placebo. Blood samples were collected 24 h before, immediately after, and 24 h after the run. RESULTS In both groups of runners, serum 25(OH)D 3 , 24,25(OH) 2 D 3 , and 3- epi -25(OH)D 3 levels significantly increased by 83%, 63%, and 182% after the ultra-marathon, respectively. The increase was most pronounced in the vitamin D group. Body mass and fat mass significantly decreased after the run in both groups. CONCLUSIONS Ultra-marathon induces the mobilization of vitamin D into the blood. Furthermore, the 24,25(OH) 2 D 3 and 3- epi -25(OH)D 3 increases imply that the exercise stimulates vitamin D metabolism.",2020,"Body mass and fat mass significantly decreased after the run in both groups. ",['27 amateur runners'],"['vitamin D 3 (150,000 IU', 'placebo', 'vitamin D']","['exercise stimulates vitamin D metabolism', '3- epi -25(OH)D 3 levels', 'Serum Levels of Vitamin D Metabolites', 'Body mass and fat mass', 'Blood samples']",[],"[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",,0.229706,"Body mass and fat mass significantly decreased after the run in both groups. ","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Mieszkowski', 'Affiliation': 'Department of Gymnastics and Dance, Gdansk University of Physical Education and Sport, 80-336 Gdansk, Poland.'}, {'ForeName': 'Błażej', 'Initials': 'B', 'LastName': 'Stankiewicz', 'Affiliation': 'Institute of Physical Education, Kazimierz Wielki University, 85-064 Bydgoszcz, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Kochanowicz', 'Affiliation': 'Department of Gymnastics and Dance, Gdansk University of Physical Education and Sport, 80-336 Gdansk, Poland.'}, {'ForeName': 'Bartłomiej', 'Initials': 'B', 'LastName': 'Niespodziński', 'Affiliation': 'Institute of Physical Education, Kazimierz Wielki University, 85-064 Bydgoszcz, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Kowalik', 'Affiliation': 'Institute of Physical Education, Kazimierz Wielki University, 85-064 Bydgoszcz, Poland.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Żmijewski', 'Affiliation': 'Department of Histology, Medical University of Gdańsk, 80-211 Gdansk, Poland.'}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Kowalski', 'Affiliation': 'Masdiag Sp. z o.o. Company, 01-882 Warsaw, Poland.'}, {'ForeName': 'Rafał', 'Initials': 'R', 'LastName': 'Rola', 'Affiliation': 'Masdiag Sp. z o.o. Company, 01-882 Warsaw, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Bieńkowski', 'Affiliation': 'Masdiag Sp. z o.o. Company, 01-882 Warsaw, Poland.'}, {'ForeName': 'Jędrzej', 'Initials': 'J', 'LastName': 'Antosiewicz', 'Affiliation': 'Department of Bioenergetics and Physiology of Exercise, Medical University of Gdansk, 80-210 Gdansk, Poland.'}]",Nutrients,['10.3390/nu12123629'] 2987,33255787,Pharmacokinetics of Sodium and Calcium Salts of (6S)-5-Methyltetrahydrofolic Acid Compared to Folic Acid and Indirect Comparison of the Two Salts.,"(6S)-5-Methyltetrahydrofolic acid ((6S)-5-Methyl-THF) salts and folic acid may differ in their abilities to raise plasma (6S)-5-Methyl-THF levels. We compared the area under the curve (AUC), C max , and T max of plasma (6S)-5-Methyl-THF after intakes of (6S)-5-Methyl-THF-Na salt (Arcofolin ® ) and folic acid. Moreover, we compared the AUCs after intakes of (6S)-5-Methyl-THF-Na and the calcium salt, (6S)-5-Methyl-THF-Ca, that were tested against folic acid in two independent studies. The study was randomized, double blind, and cross over. Twenty-four adults (12 men and 12 women) received a single oral dose of 436 µg (6S)-5-Methyl-THF-Na and an equimolar dose of folic acid (400 µg) on two kinetic days with two weeks washout period in between. The plasma concentrations of (6S)-5-Methyl-THF were measured at 9 time points between 0 and 8 h. We found that the AUC 0-8 h of plasma (6S)-5-Methyl-THF (mean (SD) = 126.0 (33.6) vs. 56.0 (25.3) nmol/L*h) and C max (36.8 (10.8) vs. 11.1 (4.1) nmol/L) were higher after administration of (6S)-5-Methyl-THF-Na than after the administration of folic acid ( p < 0.001 for both). These differences were present in men and women. Only administration of folic acid resulted in a transient increase in plasma unmetabolized folic acid (2.5 (2.0) nmol/L after 0.5 h and 4.7 (2.9) nmol/L after 1 h). Intake of (6S)-5-Methyl-THF-Na was safe. The ratios of the AUC 0-8 h for (6S)-5-Methyl-THF-Na and (6S)-5-Methyl-THF-Ca to the corresponding folic acid reference group and the delta of these AUC 0-8 h did not differ between the studies. In conclusion, a single oral dose of (6S)-5-Methyl-THF-Na caused higher AUC 0-8 h and C max of plasma (6S)-5-Methyl-THF compared to folic acid. The Na- and Ca- salts of (6S)-5-Methyl-THF are not likely to differ in their pharmacokinetics. Further studies may investigate whether supplementation of the compounds for a longer time will lead to differences in circulating or intracellular/tissue folate concentrations.",2020,Only administration of folic acid resulted in a transient increase in plasma unmetabolized folic acid (2.5 (2.0) nmol/L after 0.5 h and 4.7 (2.9) nmol/L after 1 h).,"['men and women', 'Twenty-four adults (12 men and 12 women']","['folic acid', 'Folic Acid', '6S)-5-Methyltetrahydrofolic acid ((6S)-5-Methyl-THF) salts and folic acid', 'Sodium and Calcium Salts of (6S)-5-Methyltetrahydrofolic Acid', 'single oral dose of 436 µg (6S)-5-Methyl-THF-Na and an equimolar dose of folic acid']","['plasma unmetabolized folic acid', 'Na- and Ca- salts', 'plasma concentrations of (6S)-5-Methyl-THF', 'AUC 0-8 h of plasma (6S)-5-Methyl-THF', 'area under the curve (AUC), C max , and T max of plasma (6S)-5-Methyl-THF after intakes of (6S)-5-Methyl-THF-Na salt (Arcofolin ® ) and folic acid']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C2825462', 'cui_str': 'Levomefolic acid'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",,0.0488439,Only administration of folic acid resulted in a transient increase in plasma unmetabolized folic acid (2.5 (2.0) nmol/L after 0.5 h and 4.7 (2.9) nmol/L after 1 h).,"[{'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Obeid', 'Affiliation': 'Laboratory Medicine, Department of Clinical Chemistry, Saarland University Hospital, Building 57, D-66424 Homburg/Saar, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Schön', 'Affiliation': 'BioTeSys GmbH, Schelztorstr. 54-56, D-73728 Esslingen, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Pietrzik', 'Affiliation': 'Department of Nutrition and Food Science, Rheinische Friedrich-Wilhelms University, Endenicher Allee 19B, D-53115 Bonn, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Menzel', 'Affiliation': 'BioTeSys GmbH, Schelztorstr. 54-56, D-73728 Esslingen, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Wilhelm', 'Affiliation': 'Department of Mathematics, Natural and Economic Sciences, Ulm University of Applied Sciences, Albert-Einstein-Allee 55, D-89081 Ulm, Germany.'}, {'ForeName': 'Yvo', 'Initials': 'Y', 'LastName': 'Smulders', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC, Location VUmc, 1081 HV Amsterdam, The Netherlands.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Knapp', 'Affiliation': 'Merck & Cie, Im Laternenacker 5, CH-8200 Schaffhausen, Switzerland.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Böhni', 'Affiliation': 'Merck & Cie, Im Laternenacker 5, CH-8200 Schaffhausen, Switzerland.'}]",Nutrients,['10.3390/nu12123623'] 2988,33255731,"Lactobacillus helveticus SBT2171 Alleviates Perennial Allergic Rhinitis in Japanese Adults by Suppressing Eosinophils: A Randomized, Double-Blind, Placebo-Controlled Study.","This article examines the effects of fermented milk (FM) containing Lactobacillus helveticus SBT2171 (LH2171) on the subjective symptoms of individuals with mild and moderate perennial allergy. Two hundred subjects were divided into two groups and consumed FM containing LH2171 or placebo FM once per day for 16 weeks. The primary endpoints were defined as per the degree of nasal and ocular symptoms and difficulty in daily life as determined by the Japanese guidelines for allergy rhinitis and the Japanese allergic rhinitis standard quality of life questionnaire, respectively. The secondary endpoints included parameters related to allergic symptoms in the blood and nasal fluids, as well as the mental status. The severity of allergic rhinitis significantly improved in the LH2171 group compared to that in the placebo group. Additionally, the LH2171 group showed a significantly lower degree of ""stuffy nose"" (as per the diary survey) than the placebo group. Eosinophil counts in the nasal fluids and in the blood were significantly lower in the LH2171 group compared to the placebo group. Thus, the oral administration of FM containing LH2171 cells alleviated perennial allergic rhinitis in individuals with mild and moderate symptoms, possibly via suppression of eosinophils in both the blood and nasal fluids.",2020,Eosinophil counts in the nasal fluids and in the blood were significantly lower in the LH2171 group compared to the placebo group.,"['Two hundred subjects', 'individuals with mild and moderate symptoms', 'Japanese Adults by Suppressing Eosinophils', 'individuals with mild and moderate perennial allergy']","['fermented milk (FM) containing Lactobacillus helveticus SBT2171 ', 'FM containing LH2171 or placebo FM', 'placebo', 'LH2171', 'SBT2171', 'Placebo', 'FM containing LH2171 cells']","['Eosinophil counts', 'perennial allergic rhinitis', 'severity of allergic rhinitis', 'allergic symptoms in the blood and nasal fluids, as well as the mental status', 'degree of ""stuffy nose', 'degree of nasal and ocular symptoms and difficulty in daily life as determined by the Japanese guidelines for allergy rhinitis and the Japanese allergic rhinitis standard quality of life questionnaire']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C2721639', 'cui_str': 'Perennial allergy'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0317592', 'cui_str': 'Lactobacillus helveticus'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]","[{'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0035457', 'cui_str': 'Perennial allergic rhinitis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C1444694', 'cui_str': 'Nasal fluid'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0008711', 'cui_str': 'Chronic rhinitis'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",200.0,0.109691,Eosinophil counts in the nasal fluids and in the blood were significantly lower in the LH2171 group compared to the placebo group.,"[{'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Yamashita', 'Affiliation': 'Milk Science Research Institute, MEGMILK SNOW BRAND Co. Ltd., 1-1-2, Minamidai, Kawagoe, Saitama 350-1165, Japan.'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Miyoshi', 'Affiliation': 'Milk Science Research Institute, MEGMILK SNOW BRAND Co. Ltd., 1-1-2, Minamidai, Kawagoe, Saitama 350-1165, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Iwai', 'Affiliation': 'Milk Science Research Institute, MEGMILK SNOW BRAND Co. Ltd., 1-1-2, Minamidai, Kawagoe, Saitama 350-1165, Japan.'}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Takeda', 'Affiliation': 'Department of Nutritional Sciences for Well-Being, Faculty of Health Sciences for Welfare, Kansai University of Welfare Sciences, 3-11-1, Ashigaoka, Kashiwara, Osaka 582-0026, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Ono', 'Affiliation': 'Ueno-Asagao Clinic, 6F Kairaku Building, 2-7-5, Higashiueno, Taito, Tokyo 110-0015, Japan.'}, {'ForeName': 'Toshihide', 'Initials': 'T', 'LastName': 'Kabuki', 'Affiliation': 'Milk Science Research Institute, MEGMILK SNOW BRAND Co. Ltd., 1-1-2, Minamidai, Kawagoe, Saitama 350-1165, Japan.'}]",Nutrients,['10.3390/nu12123620'] 2989,33825430,Immediate and Delayed Bond Strength of a Multimode Adhesive to Deep Coronal Dentin Following Different Root Canal Irrigation Regimens.,"PURPOSE To investigate the effects of root canal irrigants, dentin surface treatment, and timing of the restoration on the microtensile bond strength (μTBS) of a universal adhesive to deep coronal dentin. MATERIALS AND METHODS Ninety (90) intact molars were grouped according to the irrigation protocol: group 0 (saline, control group); group 1: 5.25% sodium hypochlorite (NaOCl), 17% ethylenediaminetetraacetic acid (EDTA) followed by 5.25% NaOCl; group 2: 18% etidronic acid (HEDP) + 5.25% NaOCl in a single mixture. Groups 1 and 2 were divided into 2 subgroups (n = = 10) according to the time of restoration: immediate (subgroup A) and after 7 days (subgroup B). Four other groups (n = 10) were created according to the dentin surface pretreatment and received an immediate restoration: group 3: 5.25% NaOCl - 17% EDTA and AH Plus Cleaner; group 4: 5.25% NaOCl - 17% EDTA and 100% ethanol; group 5: 5.25% NaOCl + 18% HEDP and AH Plus Cleaner; group 6: 5.25% NaOCl + 18% HEDP and 100% ethanol. μTBS testing was carried out for each subgroup and interfaces were analyzed through SEM. The μTBS was analyzed with Welch statistics and the post-hoc Games-Howell test for multiple comparisons (p < 0.05). RESULTS Statistically significant differences were observed between test groups and control groups (p < 0.001), except for group 3 (p = 0.349). No significant differences were recorded between groups 1A (27.5 ± 8.7 MPa), 2A (32.6 ± 14.5 MPa) and 3 (27.3 ± 14.3 MPa). Group 6 (48.6 ± 11.6 MPa) exhibited the highest μTBS among all tested groups. For groups 1 and 2, significantly higher values were recorded for subgroups 1B (39.3 ± 7.6 MPa) and 2B (43.8 ± 8.3 MPa) compared to subgroups 1A (27.5 ± 8.7 MPa) and 2A (32.6 ± 14.5 MPa). CONCLUSION When using NaOCl as root canal irrigant, it is advisable to delay the placement of a post-endodontic-treatment restoration.",2021,"Statistically significant differences were observed between test groups and control groups (p < 0.001), except for group 3 (p = 0.349).",['Ninety (90) intact molars'],"['irrigation protocol: group 0 (saline, control group); group 1: 5.25% sodium hypochlorite (NaOCl), 17% ethylenediaminetetraacetic acid (EDTA) followed by 5.25% NaOCl; group 2: 18% etidronic acid (HEDP) + 5.25% NaOCl', 'NaOCl + 18% HEDP and 100% ethanol', 'immediate restoration: group 3: 5.25% NaOCl - 17% EDTA and AH Plus Cleaner; group 4: 5.25% NaOCl - 17% EDTA and 100% ethanol; group 5: 5.25% NaOCl + 18% HEDP and AH Plus Cleaner']","['microtensile bond strength (μTBS', 'μTBS']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0037518', 'cui_str': 'sodium hypochlorite'}, {'cui': 'C0013618', 'cui_str': 'Edetic Acid'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0015121', 'cui_str': 'etidronic acid'}, {'cui': 'C0086268', 'cui_str': 'Etidronate'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0673096', 'cui_str': 'AH Plus'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}]","[{'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}]",10.0,0.0667935,"Statistically significant differences were observed between test groups and control groups (p < 0.001), except for group 3 (p = 0.349).","[{'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Spicciarelli', 'Affiliation': ''}, {'ForeName': 'Prasanna', 'Initials': 'P', 'LastName': 'Neelakantan', 'Affiliation': ''}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Cantini', 'Affiliation': ''}, {'ForeName': 'Dario A', 'Initials': 'DA', 'LastName': 'Marzocco', 'Affiliation': ''}, {'ForeName': 'Hani F', 'Initials': 'HF', 'LastName': 'Ounsi', 'Affiliation': ''}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Marruganti', 'Affiliation': ''}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Grandini', 'Affiliation': ''}]",The journal of adhesive dentistry,['10.3290/j.jad.b1079597'] 2990,33825427,Different Etching Times of a One-step Ceramic Primer: Effect on the Resin Bond Strength Durability to a CAD/CAM Lithium-Disilicate Glass-Ceramic.,"PURPOSE To evaluate the effect of different etching times of a self-etching ceramic primer on the microshear bond strength (µSBS) and topographic surface pattern of a lithium-disilicate glass-ceramic. MATERIALS AND METHODS Ceramic slices were subjected to an in-lab simulation of CAD/CAM milling and randomly allocated to 10 groups (n = 35) considering two factors: ""surface treatment"" in 5 levels - one control group (5% hydrofluoric acid + silane application [HF5+SIL]), and 4 experimental groups using ceramic etching/primer (Monobond Etch & Prime, E&P) with different passive application times (40 s, 2 min, 5 min, or 10 min); and ""aging"" factor in 2 levels - short-term (after 24 h), or long-term (storage for 180 days + 12,000 thermal cycles). Composite cement cylinders were built and µSBS tests were run in a universal testing machine. The failure patterns were categorized, and complementary analyses with SEM and Atomic Force Microscopy (AFM) were performed. RESULTS The groups showed statistically similar bond strengths in the short term (range 22.4 to 25.1 MPa). However, only the E&P 20s+40s (19.3 MPa) and E&P 20s+5min (21.5 MPa) groups maintained stable bond strength in the long term, and HF5+SIL (17.1 MPa) presented statistically significantly lower values than did E&P 20s+5min. The failure pattern was predominantly adhesive. The increased application time of the ceramic primer promoted greater dissolution of the glass matrix; thus, the E&P 20s+10min group presented the most complex surface characteristics in the fractal dimension analysis. CONCLUSION The self-etching ceramic primer can be used as an alternative to classical conditioning with HF plus silane, promoting stable bond strength for etching times of 40 s or 5 min of passive application.",2021,The groups showed statistically similar bond strengths in the short term (range 22.4 to 25.1 MPa).,['Ceramic slices were subjected to an in-lab simulation of CAD/CAM milling and randomly allocated to 10 groups (n = 35'],"['considering two factors: ""surface treatment"" in 5 levels - one control group (5% hydrofluoric acid + silane application [HF5+SIL', 'lithium-disilicate glass-ceramic', 'CAD/CAM Lithium-Disilicate Glass-Ceramic', 'ceramic etching/primer (Monobond Etch & Prime, E&P) with different passive application times (40 s, 2 min, 5 min, or 10 min); and ""aging"" factor in 2 levels - short-term']","['stable bond strength', 'microshear bond strength (µSBS) and topographic surface pattern', 'bond strengths']","[{'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C0599997', 'cui_str': 'Mill'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020274', 'cui_str': 'Hydrofluoric Acid'}, {'cui': 'C0037093', 'cui_str': 'Silanes'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C1528812', 'cui_str': 'lithia disilicate'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C0206415', 'cui_str': 'Oligonucleotide Primers'}, {'cui': 'C0908735', 'cui_str': 'Etch&Prime'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",,0.0375345,The groups showed statistically similar bond strengths in the short term (range 22.4 to 25.1 MPa).,"[{'ForeName': 'Kiara Serafini', 'Initials': 'KS', 'LastName': 'Dapieve', 'Affiliation': ''}, {'ForeName': 'Gabriela Carrão', 'Initials': 'GC', 'LastName': 'Aragonez', 'Affiliation': ''}, {'ForeName': 'Catina', 'Initials': 'C', 'LastName': 'Prochnow', 'Affiliation': ''}, {'ForeName': 'Thiago Augusto de Lima', 'Initials': 'TAL', 'LastName': 'Burgo', 'Affiliation': ''}, {'ForeName': 'Marilia Pivetta', 'Initials': 'MP', 'LastName': 'Rippe', 'Affiliation': ''}, {'ForeName': 'Gabriel Kalil Rocha', 'Initials': 'GKR', 'LastName': 'Pereira', 'Affiliation': ''}, {'ForeName': 'Andressa Borin', 'Initials': 'AB', 'LastName': 'Venturini', 'Affiliation': ''}, {'ForeName': 'Luiz Felipe', 'Initials': 'LF', 'LastName': 'Valandro', 'Affiliation': ''}]",The journal of adhesive dentistry,['10.3290/j.jad.b1079573'] 2991,33242020,Effectiveness of an mHealth Intervention Combining a Smartphone App and Smart Band on Body Composition in an Overweight and Obese Population: Randomized Controlled Trial (EVIDENT 3 Study).,"BACKGROUND Mobile health (mHealth) is currently among the supporting elements that may contribute to an improvement in health markers by helping people adopt healthier lifestyles. mHealth interventions have been widely reported to achieve greater weight loss than other approaches, but their effect on body composition remains unclear. OBJECTIVE This study aimed to assess the short-term (3 months) effectiveness of a mobile app and a smart band for losing weight and changing body composition in sedentary Spanish adults who are overweight or obese. METHODS A randomized controlled, multicenter clinical trial was conducted involving the participation of 440 subjects from primary care centers, with 231 subjects in the intervention group (IG; counselling with smartphone app and smart band) and 209 in the control group (CG; counselling only). Both groups were counselled about healthy diet and physical activity. For the 3-month intervention period, the IG was trained to use a smartphone app that involved self-monitoring and tailored feedback, as well as a smart band that recorded daily physical activity (Mi Band 2, Xiaomi). Body composition was measured using the InBody 230 bioimpedance device (InBody Co., Ltd), and physical activity was measured using the International Physical Activity Questionnaire. RESULTS The mHealth intervention produced a greater loss of body weight (-1.97 kg, 95% CI -2.39 to -1.54) relative to standard counselling at 3 months (-1.13 kg, 95% CI -1.56 to -0.69). Comparing groups, the IG achieved a weight loss of 0.84 kg more than the CG at 3 months. The IG showed a decrease in body fat mass (BFM; -1.84 kg, 95% CI -2.48 to -1.20), percentage of body fat (PBF; -1.22%, 95% CI -1.82% to 0.62%), and BMI (-0.77 kg/m 2 , 95% CI -0.96 to 0.57). No significant changes were observed in any of these parameters in men; among women, there was a significant decrease in BMI in the IG compared with the CG. When subjects were grouped according to baseline BMI, the overweight group experienced a change in BFM of -1.18 kg (95% CI -2.30 to -0.06) and BMI of -0.47 kg/m 2 (95% CI -0.80 to -0.13), whereas the obese group only experienced a change in BMI of -0.53 kg/m 2 (95% CI -0.86 to -0.19). When the data were analyzed according to physical activity, the moderate-vigorous physical activity group showed significant changes in BFM of -1.03 kg (95% CI -1.74 to -0.33), PBF of -0.76% (95% CI -1.32% to -0.20%), and BMI of -0.5 kg/m 2 (95% CI -0.83 to -0.19). CONCLUSIONS The results from this multicenter, randomized controlled clinical trial study show that compared with standard counselling alone, adding a self-reported app and a smart band obtained beneficial results in terms of weight loss and a reduction in BFM and PBF in female subjects with a BMI less than 30 kg/m 2 and a moderate-vigorous physical activity level. Nevertheless, further studies are needed to ensure that this profile benefits more than others from this intervention and to investigate modifications of this intervention to achieve a global effect. TRIAL REGISTRATION Clinicaltrials.gov NCT03175614; https://clinicaltrials.gov/ct2/show/NCT03175614. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) RR2-10.1097/MD.0000000000009633.",2020,"The mHealth intervention produced a greater loss of body weight (-1.97 kg, 95% CI -2.39 to -1.54) relative to standard counselling at 3 months (-1.13 kg, 95% CI -1.56 to -0.69).","['Overweight and Obese Population', 'sedentary Spanish adults who are overweight or obese', '440 subjects from primary care centers, with 231 subjects in the intervention group (IG; counselling with smartphone app and smart band) and 209 in the control group (CG; counselling only', 'female subjects with a BMI less than 30 kg/m 2 and a moderate-vigorous physical activity level']","['mHealth Intervention Combining a Smartphone App and Smart Band', 'mobile app and a smart band for losing weight and changing body composition']","['weight loss', 'BFM', 'InBody 230 bioimpedance device (InBody Co., Ltd), and physical activity', 'loss of body weight', 'body fat mass', 'International Physical Activity Questionnaire', 'BMI', 'PBF', 'Body composition', 'percentage of body fat', 'Body Composition']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1136140', 'cui_str': 'Long-Term Depression, Neurophysiologic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",440.0,0.11734,"The mHealth intervention produced a greater loss of body weight (-1.97 kg, 95% CI -2.39 to -1.54) relative to standard counselling at 3 months (-1.13 kg, 95% CI -1.56 to -0.69).","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Lugones-Sanchez', 'Affiliation': 'Institute of Biomedical Research of Salamanca (IBSAL), Primary Care Research Unit of Salamanca (APISAL), Health Service of Castilla y León (SACyL), Salamanca, Spain.'}, {'ForeName': 'Maria Antonia', 'Initials': 'MA', 'LastName': 'Sanchez-Calavera', 'Affiliation': 'Institute for Health Research Aragón (IISA), Department of Internal Medicine, Psychiatry and Dermatology, University of Zaragoza, Zaragoza, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Repiso-Gento', 'Affiliation': 'Valladolid Rural Health Center I. Health Service of Castilla y León (SACyL), Valladolid, Spain.'}, {'ForeName': 'Esther G', 'Initials': 'EG', 'LastName': 'Adalia', 'Affiliation': 'University of Castilla-La Mancha, Health and Social Research Center, Cuenca, Spain.'}, {'ForeName': 'J Ignacio', 'Initials': 'JI', 'LastName': 'Ramirez-Manent', 'Affiliation': 'Calvià Primary Care Center, Health Service of Balear Islands, Balear Islands, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Agudo-Conde', 'Affiliation': 'Institute of Biomedical Research of Salamanca (IBSAL), Primary Care Research Unit of Salamanca (APISAL), Health Service of Castilla y León (SACyL), Salamanca, Spain.'}, {'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Rodriguez-Sanchez', 'Affiliation': 'Institute of Biomedical Research of Salamanca (IBSAL), Primary Care Research Unit of Salamanca (APISAL), Health Service of Castilla y León (SACyL), Department of Medicine, University of Salamanca, Salamanca, Spain.'}, {'ForeName': 'Manuel Angel', 'Initials': 'MA', 'LastName': 'Gomez-Marcos', 'Affiliation': 'Institute of Biomedical Research of Salamanca (IBSAL), Primary Care Research Unit of Salamanca (APISAL), Health Service of Castilla y León (SACyL), Department of Medicine, University of Salamanca, Salamanca, Spain.'}, {'ForeName': 'Jose I', 'Initials': 'JI', 'LastName': 'Recio-Rodriguez', 'Affiliation': 'Institute of Biomedical Research of Salamanca (IBSAL), Primary Care Research Unit of Salamanca (APISAL), Health Service of Castilla y León (SACyL), Department of Nursing and Physiotherapy, University of Salamanca, Salamanca, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Garcia-Ortiz', 'Affiliation': 'Institute of Biomedical Research of Salamanca (IBSAL), Primary Care Research Unit of Salamanca (APISAL), Health Service of Castilla y León (SACyL), Department of Biomedical and Diagnostic Sciences, University of Salamanca, Salamanca, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Spanish Research Network for Preventive Activities and Health Promotion in Primary Care (REDIAPP), Barcelona, Spain.'}]",JMIR mHealth and uHealth,['10.2196/21771'] 2992,33242345,Is cleanliness next to abstinence? The effect of cleanliness priming on attitudes towards harm reduction strategies for people with substance use disorders.,"Can exposure to a cleanliness prime affect moral judgements towards harm reduction strategies (HRS) for individuals with substance use disorders? Our research examined (a) the effect of a cleanliness prime on attitudes towards HRS and (b) whether this effect would be attenuated by a brief educational presentation. Participants were randomly assigned to a priming condition and an educational presentation condition. Results demonstrated that (a) the cleanliness prime did not shift attitudes towards HRS, however, (b) the educational presentations significantly shifted attitudes to be more positive after the Harm Reduction presentation and more negative after the Healthy Living presentation. The literature on priming is mixed and our results support a growing body of research challenging the robustness of cleanliness priming and also demonstrates that brief presentations can change attitudes. Our research has implications for education on the benefits of HRS in reducing disease transmission, refuse in the community, and overdose deaths.",2021,Can exposure to a cleanliness prime affect moral judgements towards harm reduction strategies (HRS) for individuals with substance use disorders?,"['people with substance use disorders', 'individuals with substance use disorders']","['priming condition and an educational presentation condition', 'cleanliness priming']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}]","[{'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0522513', 'cui_str': 'With cleanliness'}]",[],,0.0190733,Can exposure to a cleanliness prime affect moral judgements towards harm reduction strategies (HRS) for individuals with substance use disorders?,"[{'ForeName': 'Tiana', 'Initials': 'T', 'LastName': 'Ciccarelli', 'Affiliation': 'Department of Biology, Wilfrid Laurier University, Waterloo, Canada.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Soberman', 'Affiliation': 'Department of Psychology, Wilfrid Laurier University, Waterloo, Canada.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Leshuk', 'Affiliation': 'Department of Psychology, Wilfrid Laurier University, Waterloo, Canada.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Cole', 'Affiliation': 'Department of Health Sciences, Wilfrid Laurier University, Waterloo, Canada.'}, {'ForeName': 'Farhana', 'Initials': 'F', 'LastName': 'Afreen', 'Affiliation': 'Department of Health Sciences, Wilfrid Laurier University, Waterloo, Canada.'}, {'ForeName': 'Laurie A', 'Initials': 'LA', 'LastName': 'Manwell', 'Affiliation': 'Department of Biology, Wilfrid Laurier University, Waterloo, Canada.'}]",International journal of psychology : Journal international de psychologie,['10.1002/ijop.12703'] 2993,33242775,MINDSET: Clinic-based decision support demonstrates longitudinal efficacy for increased epilepsy self-management adherence among Spanish speaking patients.,"BACKGROUND MINDSET, a bilingual (Eng./Span.) decision support tool was found feasible for facilitating goal-based epilepsy self-management (ESM) in the clinic. PURPOSE To evaluate the efficacy of MINDSET to increase ESM adherence among Hispanic patients. METHODS A RCT was conducted from August 2017 through January 2019. Spanish and English speaking Hispanic adult patients (n=94) with epilepsy in Arizona (n=53) and Texas (n=41) were randomly assigned within 6 neurology clinics to treatment (MINDSET plus Usual Care, hereafter referred to as MINDSET; n=46) and comparison (Usual Care Only; n=48) conditions. Self-reported self-management behavior (assessed through the Epilepsy Self-management scale) were categorized as adherent if performed 'usually' or 'always.' The proportion of adherence was compared between study conditions for 36 individual ESM behaviors and 5 ESM domains using Fischer's exact test. RESULTS The average time between visit 1 through 3 was 350+/-79 days with retention at 96.8%. Participants in the treatment condition had more college education and less unemployment. Self-management adherence improved across visits for all self-management behaviors irrespective of study condition. Compared to usual care MINDSET use led to greater ESM adherence for 86.1% behaviors (5 with statistical significance; p<0.05) and to significant improvement in the ESM domain of 'information management' (p<0.05). CONCLUSIONS Implementation of MINDSET within regular neurology visits may assist Hispanic adults with epilepsy to increase their adherence to ESM behaviors and maintain this adherence longitudinally. Replication with a broader demographic population of people with epilepsy is indicated.",2020,"Compared to usual care MINDSET use led to greater ESM adherence for 86.1% behaviors (5 with statistical significance; p<0.05) and to significant improvement in the ESM domain of 'information management' (p<0.05). ","['Hispanic patients', 'Spanish speaking patients', 'Hispanic adults with epilepsy', 'Spanish and English speaking Hispanic adult patients (n=94) with epilepsy in Arizona (n=53) and Texas (n=41']",['MINDSET'],"['college education and less unemployment', 'ESM adherence', 'average time', 'Self-reported self-management behavior']","[{'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0003787', 'cui_str': 'Arizona - US state'}, {'cui': 'C0039711', 'cui_str': 'Texas'}]",[],"[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",41.0,0.0364922,"Compared to usual care MINDSET use led to greater ESM adherence for 86.1% behaviors (5 with statistical significance; p<0.05) and to significant improvement in the ESM domain of 'information management' (p<0.05). ","[{'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Shegog', 'Affiliation': 'University of Texas School of Public Health, Behavioral Science, Houston, TX, United States. Electronic address: Ross.Shegog@uth.tmc.edu.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Begley', 'Affiliation': 'University of Texas School of Public Health, Behavioral Science, Houston, TX, United States.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Chong', 'Affiliation': 'University of Arizona, Department of Neurology, Tucson, AZ, United States.'}, {'ForeName': 'Refugio', 'Initials': 'R', 'LastName': 'Sepulveda', 'Affiliation': 'University of Arizona, Department of Neurology, Tucson, AZ, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Addy', 'Affiliation': 'University of Texas School of Public Health, Behavioral Science, Houston, TX, United States.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Martin', 'Affiliation': 'Epilepsy Foundation Central & South Texas, San Antonio, TX, United States.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Rosales', 'Affiliation': 'University of Texas School of Public Health, Behavioral Science, Houston, TX, United States.'}, {'ForeName': 'Noelia', 'Initials': 'N', 'LastName': 'Halavacs', 'Affiliation': 'Florida Health Dept., Fort Lauderdale, FL, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Labiner', 'Affiliation': 'University of Arizona, Department of Neurology, Tucson, AZ, United States.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107552'] 2994,33244655,Effect of Intraoperative Goal-Directed Fluid Management on Tissue Oxygen Tension in Obese Patients: a Randomized Controlled Trial.,"BACKGROUND Perioperative subcutaneous tissue oxygen tension (PsqO 2 ) is substantially reduced in obese surgical patients. Goal-directed fluid therapy optimizes cardiac performance and thus tissue perfusion and oxygen delivery. We therefore tested the hypothesis that intra- and postoperative PsqO 2 is significantly reduced in obese patients undergoing standard fluid management compared to goal-directed fluid administration. METHODS We randomly assigned 60 obese patients (BMI ≥ 30 kg/m 2 ) undergoing laparoscopic bariatric surgery to receive either esophageal Doppler-guided goal-directed fluid management or conventional fluid treatment. Our primary outcome parameter was intra- and postoperative PsqO 2 measured with a polarographic electrode in the subcutaneous tissue of the upper arm. A random effects linear regression model was used to analyze the effect of intervention. RESULTS Overall, mean (± SD) PsqO 2 was significantly higher in obese patients receiving goal-directed therapy compared to conventional fluid therapy (65.8 ± 28.0 mmHg vs. 53.7 ± 21.7, respectively; repeated measures design adjusted difference: 13.0 mmHg [95% CI 2.3 to 23.7; p = 0.017]). No effect was seen intraoperatively (69.6 ± 27.9 mmHg vs. 61.4 ± 28.8, difference: 9.7 mmHg [95% CI -3.8 to 23.2; p = 0.160]); however, goal-directed fluid management improved PsqO 2 in the early postoperative phase (63.1 ± 27.9 mmHg vs. 48.4 ± 12.5, difference: 14.5 mmHg [95% CI 4.1 to 24.9; p = 0.006]). Intraoperative fluid requirements did not differ between the two groups. CONCLUSIONS Goal-directed fluid therapy improved subcutaneous tissue oxygenation in obese patients. This effect was more pronounced in the early postoperative period. CLINICAL TRIAL NUMBER AND REGISTRY The study was registered at ClinicalTrials.gov (NCT01052519).",2021,"Intraoperative fluid requirements did not differ between the two groups. ","['obese patients', 'obese surgical patients', 'Obese Patients', 'obese patients undergoing standard fluid management', '60 obese patients (BMI ≥\u200930\xa0kg/m 2 ) undergoing']","['laparoscopic bariatric surgery to receive either esophageal Doppler-guided goal-directed fluid management or conventional fluid treatment', 'Intraoperative Goal-Directed Fluid Management']","['intra- and postoperative PsqO 2 measured with a polarographic electrode in the subcutaneous tissue of the upper arm', 'Tissue Oxygen Tension', 'Intraoperative fluid requirements', 'Overall, mean (± SD) PsqO 2', 'subcutaneous tissue oxygenation']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0553741', 'cui_str': 'Fluid balance regulation'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0553741', 'cui_str': 'Fluid balance regulation'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}]",60.0,0.59014,"Intraoperative fluid requirements did not differ between the two groups. ","[{'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Mühlbacher', 'Affiliation': 'Department of Surgery, Division of General Surgery, Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Luf', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Hanusch Hospital, Heinrich-Collin-Strasse 30, 1140, Vienna, Austria.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Zotti', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Herkner', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Fleischmann', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria. edith.fleischmann@meduniwien.ac.at.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Kabon', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}]",Obesity surgery,['10.1007/s11695-020-05106-x'] 2995,33247691,Efficacy of Oral Vitamin A in Reducing β-hCG Levels in Low-Risk Gestational Trophoblastic Neoplasia Patients.,"OBJECTIVE Low-risk gestational trophoblastic neoplasia (GTN) is generally treated with single agent chemotherapy and methotrexate (MTX) as a first-line therapy. Vitamin A helps to increase trophoblast cell regression, as well as to decrease β-hCG levels. Vitamin A also increases the effectiveness of MTX by inducing more malignant cell death than MTX alone. Therefore, the aim of the current study was to analyze the changes in β-hCG levels in low-risk GTN patients following vitamin A administration. METHODS This study was a randomized clinical trial, which examined initial serum vitamin A and β-hCG levels in GTN patients before and after three cycles of MTX therapy. Patients were given vitamin A supplementation of 6,000 IU (1.8 mg RAEs) per day, and the changes in serum β-hCG were observed after three cycles. Patients were grouped by β-hCG levels (decreased or stagnant). RESULTS A total of 32 low-risks GTN patients were divided into the intervention group (16 patients who received vitamin A supplementation) and the control group (16 patients who did not receive vitamin A supplementation). In the intervention group, the average initial β-hCG level was 170,949.3 ± 354,452.1 mIU/mL, and the average β-hCG post-cycle level was 1,611.9 ± 3,652.5 mIU/mL. In the control group, the average initial β-hCG level was 178,834.1 ± 2913844.6 mIU/mL, and the average β-hCG post-cycle level was 25,388.5 ± 58,437.7 mIU/mL. CONCLUSION In patients with low-risk GTN who underwent MTX chemotherapy, the levels of β-hCG and the incidence of chemo resistance in the intervention group were lower than those in the control group. Older age may also influence the incidence of chemo resistance in GTN patients. Oral administration of 6,000 IU vitamin A could help to reduce β-hCG levels in low-risk GTN patients who receive MTX chemotherapy.
.",2020,"In the intervention group, the average initial β-hCG level was 170,949.3 ± 354,452.1 mIU/mL, and the average β-hCG post-cycle level was 1,611.9 ± 3,652.5 mIU/mL. In the control group, the average initial β-hCG level was 178,834.1 ± 2913844.6 mIU/mL, and the average β-hCG post-cycle level was 25,388.5 ± 58,437.7 mIU/mL. CONCLUSION In patients with low-risk GTN who underwent MTX chemotherapy, the levels of β-hCG and the incidence of chemo resistance in the intervention group were lower than those in the control group.","['low-risk GTN patients who receive MTX chemotherapy.
0.3 for all). However, empagliflozin increased plasma osmolality (delta osmolality at 72 h: 5 ± 8 vs. 2 ± 5 mOsm/kg; P = 0.049). Finally, there was an early decline in estimated glomerular filtration rate with empagliflozin vs. placebo (-10 ± 12 vs. -2 ± 12 mL/min/1.73 m 2 ; P = 0.009), which recovered within 30 days. CONCLUSION In patients with acute HF, empagliflozin increased fractional glucose excretion and plasma osmolality, without affecting fractional sodium excretion or urine osmolality and caused a temporary decline in estimated glomerular filtration rate. This suggests that empagliflozin stimulates osmotic diuresis through increased glycosuria rather than natriuresis in patients with acute HF.",2021,"Empagliflozin increased fractional glucose excretion with a peak after 24 hours (21.8 vs 0.1%; P<0.001), without affecting plasma glucose concentration, while fractional sodium and chloride excretion and urinary osmolality remained unchanged (P for all >0.3).","['patients with acute HF', 'Patients were 76 (range 38-89) years old and 33% had diabetes', 'Patients with Acute Heart Failure', 'patients with heart failure (HF']","['empagliflozin', 'placebo', 'Empagliflozin', 'loop diuretics', 'Sodium-glucose cotransporter-2 (SGLT2) inhibitors']","['plasma glucose concentration, while fractional sodium and chloride excretion and urinary osmolality', 'fractional glucose excretion and plasma osmolality', 'Renal Sodium and Glucose Handling', 'fractional glucose excretion', 'plasma osmolality (delta osmolality', 'renal sodium and glucose handling']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0354100', 'cui_str': 'Loop diuretic'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0008203', 'cui_str': 'Chloride salt'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0086741', 'cui_str': 'Osmolality'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0860721', 'cui_str': 'Plasma osmolality'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0439097', 'cui_str': 'Delta'}]",,0.100313,"Empagliflozin increased fractional glucose excretion with a peak after 24 hours (21.8 vs 0.1%; P<0.001), without affecting plasma glucose concentration, while fractional sodium and chloride excretion and urinary osmolality remained unchanged (P for all >0.3).","[{'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Boorsma', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Joost C', 'Initials': 'JC', 'LastName': 'Beusekamp', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Jozine M', 'Initials': 'JM', 'LastName': 'Ter Maaten', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Sylwia M', 'Initials': 'SM', 'LastName': 'Figarska', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'A H Jan', 'Initials': 'AHJ', 'LastName': 'Danser', 'Affiliation': 'Department of Internal Medicine, Division of Pharmacology, Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'van Veldhuisen', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'van der Meer', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Damman', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}]",European journal of heart failure,['10.1002/ejhf.2066'] 2998,33250038,Renal Safety of Multimodal Brain Imaging Followed by Endovascular Therapy.,"BACKGROUND AND PURPOSE Contrast-enhanced noninvasive angiography and perfusion imaging are recommended to identify eligible patients for endovascular therapy (EVT) in extended time windows (>6 hours or wake-up). If eligible, additional intraarterial contrast exposure will occur during EVT. We aimed to study the renal safety in the DEFUSE 3 (Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke) population, selected with contrast-enhanced multimodal Imaging and randomized to EVT versus medical management. METHODS In the randomized DEFUSE 3 trial population, we compared changes in serum creatinine between baseline (before randomization) and 24 hours later. The primary outcome was the relative change in creatinine level between baseline and 24 hours in the EVT versus medical arm. The secondary outcome was a comparison between computed tomography (CT) versus magnetic resonance imaging selection in the EVT arm. The safety outcome was a comparison of the proportion of patients with criteria for contrast-associated kidney injury in the EVT versus medical arm and a comparison between CT versus magnetic resonance imaging selection in the EVT arm. RESULTS In the DEFUSE 3 population (n=182, age 69±13, 51% female), mean creatinine decreased from a baseline of 0.98±0.33 mg/dL to 0.88±0.28 mg/dL at 24 hours ( P <0.001). There was no difference in change between treatment groups: relative to baseline, there was a 6.3% reduction in the EVT group versus 9.2% in the medical group, P =0.294. Absolute decrease -0.08±0.18 in EVT versus -0.12±0.18 in medical, P =0.135; Among patients treated with EVT, there was no difference in 24-hour creatinine level changes between patients who were selected with CT angiography/CT perfusion (-0.08±0.18) versus magnetic resonance imaging (-0.07±0.19), P =0.808 or 6.8% reduction versus 4.8%, P =0.696. In the EVT arm, contrast-associated kidney injury was encountered in 4 out of 91 (4.4%) versus 2/90 (2.2%) in the medical arm P =0.682. In the EVT arm, contrast-associated kidney injury was evenly distributed between magnetic resonance imaging (1/22, 4.6%) versus CT 3 out of 69 (4.4%), P =1.0. CONCLUSIONS Perfusion imaging before EVT was not associated with evidence of decline in renal function. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02586415.",2021,"There was no difference in change between treatment groups: relative to baseline, there was a 6.3% reduction in the EVT group versus 9.2% in the medical group, P =0.294.",['eligible patients for endovascular therapy (EVT) in extended time windows '],"['DEFUSE 3 (Endovascular Therapy', 'Multimodal Brain Imaging Followed by Endovascular Therapy', 'computed tomography (CT', 'EVT']","['kidney injury', 'serum creatinine', 'relative change in creatinine level', 'renal safety', 'mean creatinine', '24-hour creatinine level changes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0557702', 'cui_str': 'Window'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0203860', 'cui_str': 'Imaging of brain'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]","[{'cui': 'C0160420', 'cui_str': 'Injury of kidney'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0201975', 'cui_str': 'Creatinine measurement'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.106145,"There was no difference in change between treatment groups: relative to baseline, there was a 6.3% reduction in the EVT group versus 9.2% in the medical group, P =0.294.","[{'ForeName': 'Carlo W', 'Initials': 'CW', 'LastName': 'Cereda', 'Affiliation': 'Stroke Center EOC, Neurocenter of Southern Switzerland, Lugano (C.W.C.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mlynash', 'Affiliation': 'Stanford Stroke Center (M.M., S.K., M.G.L., G.W.A.), Stanford University School of Medicine, CA.'}, {'ForeName': 'Pietro E', 'Initials': 'PE', 'LastName': 'Cippà', 'Affiliation': 'Division of Nephrology, EOC, Lugano, Switzerland (P.E.C.).'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Kemp', 'Affiliation': 'Stanford Stroke Center (M.M., S.K., M.G.L., G.W.A.), Stanford University School of Medicine, CA.'}, {'ForeName': 'Jeremy J', 'Initials': 'JJ', 'LastName': 'Heit', 'Affiliation': 'Department of Radiology (J.J.H., M.P.M.), Stanford University School of Medicine, CA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Marks', 'Affiliation': 'Department of Radiology (J.J.H., M.P.M.), Stanford University School of Medicine, CA.'}, {'ForeName': 'Maarten G', 'Initials': 'MG', 'LastName': 'Lansberg', 'Affiliation': 'Stanford Stroke Center (M.M., S.K., M.G.L., G.W.A.), Stanford University School of Medicine, CA.'}, {'ForeName': 'Gregory W', 'Initials': 'GW', 'LastName': 'Albers', 'Affiliation': 'Stanford Stroke Center (M.M., S.K., M.G.L., G.W.A.), Stanford University School of Medicine, CA.'}]",Stroke,['10.1161/STROKEAHA.120.030816'] 2999,33249580,Migraine Headache Day Response Rates and the Implications to Patient Functioning: An Evaluation of 3 Randomized Phase 3 Clinical Trials of Galcanezumab in Patients With Migraine.,"OBJECTIVE This post hoc study investigated the relationship between patient response in terms of migraine headache day reduction and patient-reported outcomes of health-related quality of life (HRQoL) and disability categories. BACKGROUND Migraine causes considerable disease-related disability and negatively impacts HRQoL of patients. Calcitonin gene-related peptide inhibitors improve these outcomes and may eliminate disability due to migraine in some patients. METHODS Analyses used data from 3 double-blind, placebo (PBO)-controlled, phase 3 studies in adults with episodic migraine (EM) (EVOLVE-1: N = 858 and EVOLVE-2: N = 915) or chronic migraine (CM) (REGAIN: N = 1113). Patients were randomized 2:1:1 to subcutaneous injection of PBO, galcanezumab (GMB) 120 mg, or GMB 240 mg once monthly for 6 months in EVOLVE-1 and -2 and for 3 months in REGAIN. Primary endpoint was overall mean change from baseline in monthly migraine headache days. Patients were divided into 4 response-level groups based on percent change from baseline (<30%, ≥30% to <50%, ≥50% to <75%, ≥75%). Patient-reported outcomes included the 14-item Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ) and Migraine Disability Assessment (MIDAS) questionnaire. RESULTS Among patients with migraine, mean improvements from baseline in MSQ domain scores increased with each successive level of migraine headache day response. On a 100-pt scale, increases in Role Function-Restrictive score in EM were 16.8 and 36.0 at the <30% and ≥75% response levels, respectively, and for CM were 10.7 and 46.5. Similar patterns in scores were observed for the Role Function-Preventive and Emotional Function domains. Examination of improvement in MSQ item score by treatment group showed that, in patients with EM, approximately 10 to 20% more GMB-treated patients (N = 796 for GMB 120 mg and GMB 240 mg) had improvements in all 14 MSQ items compared with PBO-treated patients (N = 773) (all P < .001). In patients with CM, 3 to 16% more GMB-treated patients (N = 507) had improvements in the 14 MSQ items compared with PBO (N = 494), though differences were statistically significant in only 19 of 28 comparisons. At baseline, mean MIDAS scores (EM, 33.1; CM, 67.2) indicated severe mean disability for patients with EM and very severe disability for patients with CM. Among patients with EM, 215 of 425 (50.6%) of those treated with GMB 120 mg and 212 of 413 (51.3%) treated with 240 mg had little/no disability due to migraine after 6 months (PBO: 277 of 832 (33.3%), P < .001 for both). Among patients with CM, 50 of 254 (19.7%) of those treated with GMB 120 mg and 54 of 258 (20.9%) treated with 240 mg reached the level of little/no disability after 3 months of treatment (PBO: 70 of 504 (13.9%), P = .045 for 120 mg, P = .017 for 240 mg). CONCLUSIONS Because migraine greatly impairs an individual's ability to participate in activities of daily living, measurements of HRQoL are essential in clinical research. This study showed that function in daily life, as measured by MSQ score, improved as migraine headache days were reduced and that GMB-treated patients were more likely to see improvement in MSQ item scores compared with PBO-treated patients. Elimination of migraine-related disability was also more frequent in GMB-treated patients compared with placebo-treated patients.",2020,"Among patients with migraine, mean improvements from baseline in MSQ domain scores increased with each successive level of migraine headache day response.","['Patients With Migraine', 'Patient Functioning', 'adults with episodic migraine (EM) ']","['subcutaneous injection of PBO, galcanezumab (GMB', 'placebo', 'EVOLVE-1', 'Calcitonin', 'chronic migraine (CM', 'Galcanezumab', 'placebo (PBO)-controlled', 'GMB']","['MSQ item scores', 'overall mean change from baseline in monthly migraine headache days', 'Elimination of migraine-related disability', 'Migraine Headache Day Response Rates', 'severe mean disability', 'MSQ domain scores', 'Role Function-Restrictive score in EM', 'MSQ item score', 'migraine headache days', 'mean MIDAS scores', 'MSQ score', '14-item Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ) and Migraine Disability Assessment (MIDAS) questionnaire', 'severe disability', 'level of little/no disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}]","[{'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4694273', 'cui_str': 'galcanezumab'}, {'cui': 'C0332253', 'cui_str': 'Evolving'}, {'cui': 'C0006668', 'cui_str': 'Calcitonin'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0559741', 'cui_str': 'Item score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C1309950', 'cui_str': 'GOLPH3 protein, human'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023882', 'cui_str': 'Spastic diplegia'}]",1113.0,0.0741682,"Among patients with migraine, mean improvements from baseline in MSQ domain scores increased with each successive level of migraine headache day response.","[{'ForeName': 'Janet H', 'Initials': 'JH', 'LastName': 'Ford', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Kurth', 'Affiliation': 'Institute of Public Health, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Amaal J', 'Initials': 'AJ', 'LastName': 'Starling', 'Affiliation': 'Mayo Clinic, Scottsdale, AZ, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Ayer', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Linda A', 'Initials': 'LA', 'LastName': 'Wietecha', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Martha D', 'Initials': 'MD', 'LastName': 'Port', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Mallikarjuna', 'Initials': 'M', 'LastName': 'Rettiganti', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Dustin D', 'Initials': 'DD', 'LastName': 'Ruff', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.'}]",Headache,['10.1111/head.14013'] 3000,33253910,Safety and feasibility of mesenchymal stem cell therapy in patients with aqueous deficient dry eye disease.,"PURPOSE To evaluate the safety and feasibility of injecting allogeneic adipose-derived mesenchymal stem cells (ASCs) into the lacrimal gland (LG) as a treatment of aqueous deficient dry eye disease (ADDE). METHODS In this open-label, 5-visit clinical trial (baseline, treatment and weeks 1, 4 and 16) seven subjects with ADDE received one transconjunctival injection of allogeneic ASCs into the LG in one eye. The ASC product contained 22 million ASCs/ml and the injected volume was maximally 50% of the LG volume as determined on magnetic resonance imaging (MRI). Treatment related adverse events (AEs) were assessed at each visit (primary endpoint). Ocular Surface Disease Index (OSDI), tear osmolarity, tear film breakup time (TBUT), corneal staining (Oxford grade) and Schirmer's I test were assessed at each timepoint. RESULTS No AEs related to the study treatment were observed. Mean follow-up time was 126 days after treatment. The mean OSDI score decreased from 58.9 ± 20.6 at baseline to 34.1 ± 21.6 (p < 0.002). In the study eye mean tear osmolarity decreased from 312.9 ± 10.4 to 291.6 ± 10.9 mosm/l (p < 0.002), mean TBUT increased from 3.7 ± 1.5 to 7.1 ± 1.9 s (p < 0.002), mean Schirmer's I test increased from 4.6 ± 0.7 to 8.1 ± 3.1 mm/5 min (p < 0.03), while mean Oxford grade showed a trend towards a decrease from 2.4 ± 0.7 to 1.3 ± 1 (p < 0.10). CONCLUSION Our trial suggests that injection of allogeneic ASCs into the LG is a safe and feasible treatment of severe ADDE. A randomized placebo-controlled trial aimed at elucidating the therapeutic effect of allogeneic ASCs in a larger patient cohort from our research group is currently underway.",2021,"Ocular Surface Disease Index (OSDI), tear osmolarity, tear film breakup time (TBUT), corneal staining (Oxford grade) and Schirmer's I test were assessed at each timepoint. ","['patients with aqueous deficient dry eye disease', 'aqueous deficient dry eye disease (ADDE']","['placebo', 'allogeneic adipose-derived mesenchymal stem cells (ASCs', 'mesenchymal stem cell therapy', 'transconjunctival injection of allogeneic ASCs', 'allogeneic ASCs']","['mean TBUT', ""Ocular Surface Disease Index (OSDI), tear osmolarity, tear film breakup time (TBUT), corneal staining (Oxford grade) and Schirmer's I test"", 'mean OSDI score', 'mean tear osmolarity', 'adverse events (AEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4704950', 'cui_str': 'Mesenchymal Stem Cells, Adipose-Derived'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0442347', 'cui_str': 'Transconjunctival approach'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0029387', 'cui_str': 'Osmolarity'}, {'cui': 'C0423232', 'cui_str': 'Corneal epithelial staining pattern'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C1301514', 'cui_str': 'Schirmer I test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",7.0,0.0464932,"Ocular Surface Disease Index (OSDI), tear osmolarity, tear film breakup time (TBUT), corneal staining (Oxford grade) and Schirmer's I test were assessed at each timepoint. ","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Møller-Hansen', 'Affiliation': 'Department of Ophthalmology, Rigshospitalet-Glostrup, University of Copenhagen, Denmark. Electronic address: michael.moeller-hansen@regionh.dk.'}, {'ForeName': 'Ann-Cathrine', 'Initials': 'AC', 'LastName': 'Larsen', 'Affiliation': 'Department of Ophthalmology, Rigshospitalet-Glostrup, University of Copenhagen, Denmark.'}, {'ForeName': 'Peter Bjerre', 'Initials': 'PB', 'LastName': 'Toft', 'Affiliation': 'Department of Ophthalmology, Rigshospitalet-Glostrup, University of Copenhagen, Denmark.'}, {'ForeName': 'Charlotte Duch', 'Initials': 'CD', 'LastName': 'Lynggaard', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Schwartz', 'Affiliation': 'Department of Diagnostic Radiology, Rigshospitalet-Glostrup, University of Copenhagen, Denmark.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Bruunsgaard', 'Affiliation': 'Department of Clinical Immunology, Rigshospitalet, And Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Mandana', 'Initials': 'M', 'LastName': 'Haack-Sørensen', 'Affiliation': 'Cardiology Stem Cell Centre, The Heart Centre, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Ekblond', 'Affiliation': 'Cardiology Stem Cell Centre, The Heart Centre, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kastrup', 'Affiliation': 'Cardiology Stem Cell Centre, The Heart Centre, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Heegaard', 'Affiliation': 'Department of Ophthalmology, Rigshospitalet-Glostrup, University of Copenhagen, Denmark.'}]",The ocular surface,['10.1016/j.jtos.2020.11.013'] 3001,33258495,Preoperative decolonization and periprosthetic joint infections-A randomized controlled trial with 2-year follow-up.,"Preoperative decolonization, especially of Staphylococcus aureus carriers, has been proposed to reduce periprosthetic joint infections (PJI), but the evidence-based consensus is still lacking and data on long-term outcomes is scarce. In a previous randomized, single-blinded trial, decolonization produced no significant reduction of surgical site infections in overall elective orthopedic surgery at 3-month follow-up. A 2-year follow-up was then performed to specifically detect the impact of decolonization on delayed-onset PJI (3-24 months after surgery). Between November 2015 and September 2017, 613 of 1318 recruited patients underwent prosthetic surgery. Individuals were allocated into either the S. aureus carrier group (34%, 207 of 613 patients) or the noncarrier group (406 of 613 patients), according to nasal swab screening results. Both groups were then randomized into intervention and control arms. In the S. aureus group, the intervention consisted of daily chlorhexidine showers and application of mupirocin nasal ointment twice a day for 5 days before surgery. In noncarriers, only chlorhexidine showers were prescribed. Sample size calculation was based on the initial trial for overall and not for the prosthetic surgery group. No PJI was found at 2 years in either the carrier or in the noncarrier group. Therefore, no definite conclusion about the efficacy of preoperative decolonization to reduce PJI can be drawn. PJI proportions in this study were lower than described in the literature (mostly around 0.3%). Despite the insufficient sample size, this trial is the largest randomized trial on decolonization with a long-term follow-up, and results may be helpful for future meta-analyses.",2021,"In a previous randomized, single-blinded trial, decolonization produced no significant reduction of surgical site infections in overall elective orthopaedic surgery at 3-month follow-up.","['Between November 2014 and September 2017, 613 of 1,318 recruited patients underwent']","['chlorhexidine', 'prosthetic surgery', 'chlorhexidine showers and application of mupirocin nasal ointment']","['surgical site infections', 'PJI proportions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0541748', 'cui_str': 'Shower'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C1241186', 'cui_str': 'Mupirocin Nasal Ointment [Bactroban]'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0157749', 'cui_str': 'Arthropathy associated with infection'}]",1318.0,0.0873429,"In a previous randomized, single-blinded trial, decolonization produced no significant reduction of surgical site infections in overall elective orthopaedic surgery at 3-month follow-up.","[{'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Rohrer', 'Affiliation': 'Department of Internal Medicine, Sonnenhofspital, Bern, Switzerland.'}, {'ForeName': 'Malte', 'Initials': 'M', 'LastName': 'Wendt', 'Affiliation': 'Department of Dermatology, Hautärzte Hamburg, Hamburg, Germany.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Noetzli', 'Affiliation': 'Faculty of Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Risch', 'Affiliation': 'Faculty of Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bodmer', 'Affiliation': 'Department of Microbiology, Labormedizinisches Zentrum Dr Risch, Koeniz, Switzerland.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Cottagnoud', 'Affiliation': 'Department of Internal Medicine, Sonnenhofspital, Bern, Switzerland.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Hermann', 'Affiliation': 'Swiss Institute for Translational and Entrepreneurial Medicine, Stiftung Lindenhof, Bern, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Limacher', 'Affiliation': 'Clinical Trial Unit, CTU Bern, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Brigitta', 'Initials': 'B', 'LastName': 'Gahl', 'Affiliation': 'Clinical Trial Unit, CTU Bern, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Bruegger', 'Affiliation': 'Department of Internal Medicine, Sonnenhofspital, Bern, Switzerland.'}]",Journal of orthopaedic research : official publication of the Orthopaedic Research Society,['10.1002/jor.24916'] 3002,33823215,The influence of partners on successful lifestyle modification in patients with coronary artery disease.,"BACKGROUND Marital status is associated with prognosis in patients with cardiovascular disease (CVD). However, the influence of partners on successful modification of lifestyle-related risk factors (LRFs) in secondary CVD prevention is unclear. Therefore, we studied the association between the presence of a partner, partner participation in lifestyle interventions and LRF modification in patients with coronary artery disease (CAD). METHODS In a secondary analysis of the RESPONSE-2 trial (n = 711), which compared nurse-coordinated referral to community-based lifestyle programs (smoking cessation, weight reduction and/or physical activity) to usual care in patients with CAD, we investigated the association between the presence of a partner and the level of partner participation on improvement in >1 LRF (urinary cotinine <200 ng/l, ≥5% weight reduction, ≥10% increased 6-min walking distance) without deterioration in other LRFs at 12 months follow-up. RESULTS The proportion of patients with a partner was 80% (571/711); 19% women (108/571). In the intervention group, 48% (141/293) had a participating partner in ≥1 lifestyle program. Overall, the presence of a partner was associated with patients' successful LRF modification (adjusted risk ratio (aRR) 1.93, 95% confidence interval (CI) 1.40-2.51). A participating partner was associated with successful weight reduction (aRR 1.73, 95% CI 1.15-2.35). CONCLUSION The presence of a partner is associated with LRF improvement in patients with CAD. Moreover, patients with partners participating in lifestyle programs are more successful in reducing weight. Involving partners of CAD patients in weight reduction interventions should be considered in routine practice.",2021,"A participating partner was associated with successful weight reduction (aRR 1.73, 95% CI 1.15-2.35). ","['patients with CAD', 'patients with coronary artery disease (CAD', 'patients with cardiovascular disease (CVD', 'patients with partners participating in lifestyle programs', 'patients with coronary artery disease']",[],"['6-min walking distance) without deterioration in other LRFs', 'successful in reducing weight', 'successful weight reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],"[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.0280794,"A participating partner was associated with successful weight reduction (aRR 1.73, 95% CI 1.15-2.35). ","[{'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'Verweij', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Cardiology, Amsterdam, the Netherlands; Center of Expertise Urban Vitality, Faculty of Health, Amsterdam University of Applied Science, Amsterdam, the Netherlands. Electronic address: l.verweij@amsterdamumc.nl.'}, {'ForeName': 'Harald T', 'Initials': 'HT', 'LastName': 'Jørstad', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Cardiology, Amsterdam, the Netherlands.'}, {'ForeName': 'Madelon', 'Initials': 'M', 'LastName': 'Minneboo', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Cardiology, Amsterdam, the Netherlands.'}, {'ForeName': 'Gerben', 'Initials': 'G', 'LastName': 'Ter Riet', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Cardiology, Amsterdam, the Netherlands; Center of Expertise Urban Vitality, Faculty of Health, Amsterdam University of Applied Science, Amsterdam, the Netherlands.'}, {'ForeName': 'Ron J G', 'Initials': 'RJG', 'LastName': 'Peters', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Cardiology, Amsterdam, the Netherlands.'}, {'ForeName': 'Wilma J M', 'Initials': 'WJM', 'LastName': 'Scholte Op Reimer', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Cardiology, Amsterdam, the Netherlands; University of Applied Sciences Utrecht, Research Group Chronic Diseases, Utrecht, the Netherlands.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Snaterse', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Cardiology, Amsterdam, the Netherlands; Center of Expertise Urban Vitality, Faculty of Health, Amsterdam University of Applied Science, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of cardiology,['10.1016/j.ijcard.2021.04.007'] 3003,33823211,The impact of introducing a videolaryngoscope in the initial training of laryngoscopy for undergraduate medical students: a simulation randomized trial.,"INTRODUCTION Adequate and continuous airway management by health professionals is fundamental to ensure patient safety and protection. Among several techniques, laryngoscopy for orotracheal intubation is considered a basic skill, so it is taught and learned in medical school and used during the future years of professional practice. However, in some clinical scenarios, physical and anatomical characteristics can make laryngoscopy exceedingly difficult. In the last decade, some new devices have emerged to apply indirect or video-assisted imaging systems, so-called videolaryngoscopes. They have shown great efficiency in difficult intubation cases and have improved teaching and training. Our study introduced a videolaryngoscope, the McGrath™ MAC, in the regular laryngoscopy training rotation for 3 rd -year undergraduate medical students and evaluated whether there was any associated optimization of the students' performance. METHOD Students from two different classes and years (2017 and 2018) were randomly divided into two groups and received theoretical and practical training in the techniques of Direct Laryngoscopy (DL) and Videolaryngoscopy (VL). The students in each group applied the manoeuvres and simulated three tracheal intubation attempts on mannequins. They were evaluated for their success rate on the first attempt, the time required to finalize the intubation, and the visualization of the glottic structures according to the classification of Cormack-Lehane (C&L). RESULTS Two hundred and four students with an average age of 21 ± 2 years participated in the study; the groups were similar. There was a significant difference between the VL and DL groups in the 1 st attempt success rate (97% and 89.4%, respectively, p = 0.0497 - 95% CI), but such a difference was not seen for the other attempts or regarding the number of oesophageal intubations (3% and 7.7%). The students in the VL group were faster than those in the DL group in all intubation attempts; in parallel, the vast majority of the VL group reported excellent visualization conditions, with 75% of the attempts classified as Cormack-Lehane grade 1. CONCLUSION The introduction of a videolaryngoscope in medical students' training improved the visualization of anatomical structures and allowed tracheal intubation maneuvers to be performed faster and with a higher success rate on the first attempt. Thus, under the conditions of this prospective study, the videolaryngoscope had a positive impact on training and proved to be a promising tool for teaching laryngoscopy.",2021,"There was a significant difference between the VL and DL groups in the 1 st attempt success rate (97% and 89.4%, respectively, p =  0.0497 - 95% CI), but such a difference was not seen for the other attempts or regarding the number of oesophageal intubations (3% and 7.7%).","['Two hundred and four students with an average age of 21\u2009±\u20092 years participated in the study; the groups were similar', 'undergraduate medical students', 'Students from two different classes and years (2017 and 2018', '3 rd -year undergraduate medical students']",['theoretical and practical training in the techniques of Direct Laryngoscopy (DL) and Videolaryngoscopy (VL'],"['success rate', 'number of oesophageal intubations', 'excellent visualization conditions']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0392823', 'cui_str': 'Direct laryngoscopy'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2939167', 'cui_str': 'Intubation of esophagus'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",204.0,0.0037586,"There was a significant difference between the VL and DL groups in the 1 st attempt success rate (97% and 89.4%, respectively, p =  0.0497 - 95% CI), but such a difference was not seen for the other attempts or regarding the number of oesophageal intubations (3% and 7.7%).","[{'ForeName': 'Mauricio Luiz', 'Initials': 'ML', 'LastName': 'Malito', 'Affiliation': 'CET/SBA da Santa Casa de São Paulo, São Paulo, SP, Brazil; Hospital AACD, CTVA (Centro de Treinamento em Vias Aéreas), São Paulo, SP, Brazil. Electronic address: mmalito@uol.com.br.'}, {'ForeName': 'Ligia Andrade da Silva Telles', 'Initials': 'LADST', 'LastName': 'Mathias', 'Affiliation': 'Santa Casa de São Paulo, Faculdade de Ciências Médicas, São Paulo, SP, Brazil; Promatre Paulista, Serviço de Anestesia, São Paulo, SP, Brazil.'}, {'ForeName': 'Aldemar', 'Initials': 'A', 'LastName': 'Kimura Junior', 'Affiliation': 'CET/SBA da Santa Casa de São Paulo, São Paulo, SP, Brazil; Hospital Sabará, São Paulo, SP, Brazil; Hospital AACD, São Paulo, SP, Brazil.'}, {'ForeName': 'Guilherme Haelvoet', 'Initials': 'GH', 'LastName': 'Correa', 'Affiliation': 'Hospital Santa Joana, São Paulo, SP, Brazil.'}, {'ForeName': 'Vitor Ramalho', 'Initials': 'VR', 'LastName': 'Bardauil', 'Affiliation': 'CET/SBA da Santa Casa de São Paulo, São Paulo, SP, Brazil.'}]",Brazilian journal of anesthesiology (Elsevier),['10.1016/j.bjane.2021.02.048'] 3004,33823208,Does local anesthetic temperature affect the onset and duration of ultrasound-guided infraclavicular brachial plexus nerve block?: a randomized clinical trial.,"BACKGROUND Infraclavicular brachial plexus nerve block is a commonly performed anesthesiology technique in the upper extremity. Local anesthetics may be administered at different temperatures for both neuraxial and peripheral nerve blocks. We aimed to evaluate the effects of the temperature of the local anesthetic at the time of administration on the onset and duration of sensory and motor blocks in infraclavicular brachial plexus nerve block. METHODS A total of 80 patients undergoing elective upper extremity surgery were randomly assigned to one of the following groups using a computer-based randomization software; low temperature (4 °C) (Group L, n = 26), room temperature (25 °C) (Group R, n = 27) and warmed (37 °C) (Group W, n = 27). A 1:1 mixture of 2% lidocaine and 0.5% bupivacaine was used as local anesthetic. Infraclavicular brachial plexus nerve block was performed under ultrasound guidance in all patients preoperatively. The onset and duration of sensory and motor blocks were recorded. RESULTS Each group had different onset of motor (p < 0.001) and sensory (p < 0.001) blocks. The duration of motor block was similar between groups (p = 221). However, a significant difference was found in the duration of sensory block between group L (399.1 ± 40.8 min) and group R (379.6 ± 27.6 min) (p = 0.043). There was no complication related to nerve block procedure. CONCLUSIONS The administration of the local anesthetic at lower temperatures may prolong the onset of both motor and sensory blocks in infraclavicular brachial plexus nerve block.",2021,Each group had different onset of motor (p < 0.001) and sensory (p < 0.001) blocks.,['80 patients undergoing elective upper extremity surgery'],"['lidocaine', 'bupivacaine']","['duration of sensory block', 'duration of motor block', 'onset and duration of sensory and motor blocks']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]",80.0,0.113577,Each group had different onset of motor (p < 0.001) and sensory (p < 0.001) blocks.,"[{'ForeName': 'Ilker', 'Initials': 'I', 'LastName': 'Ince', 'Affiliation': 'Ataturk University School of Medicine, Department of Anesthesiology and Reanimation, Erzurum, Turkey; Ataturk University, Anesthesiology Clinical Research Office, Erzurum, Turkey; Cleveland Clinic, Outcomes Research Consortium, Cleveland, United States. Electronic address: ilkerince1983@yahoo.com.'}, {'ForeName': 'Muhammed Ali', 'Initials': 'MA', 'LastName': 'Arı', 'Affiliation': 'Ataturk University School of Medicine, Department of Anesthesiology and Reanimation, Erzurum, Turkey.'}, {'ForeName': 'Aysenur', 'Initials': 'A', 'LastName': 'Dostbil', 'Affiliation': 'Ataturk University School of Medicine, Department of Anesthesiology and Reanimation, Erzurum, Turkey; Ataturk University, Anesthesiology Clinical Research Office, Erzurum, Turkey.'}, {'ForeName': 'Esra Kutlu', 'Initials': 'EK', 'LastName': 'Yalcin', 'Affiliation': 'Cleveland Clinic, Outcomes Research Consortium, Cleveland, United States.'}, {'ForeName': 'Ozgur', 'Initials': 'O', 'LastName': 'Ozmen', 'Affiliation': 'Ataturk University School of Medicine, Department of Anesthesiology and Reanimation, Erzurum, Turkey; Ataturk University, Anesthesiology Clinical Research Office, Erzurum, Turkey.'}, {'ForeName': 'M Zafeer', 'Initials': 'MZ', 'LastName': 'Khan', 'Affiliation': 'Cleveland Clinic, Outcomes Research Consortium, Cleveland, United States.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Shimada', 'Affiliation': 'Cleveland Clinic, Outcomes Research Consortium, Cleveland, United States; National Defense College, Department of Pharmacology, Tokorozawa, Japan.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Aksoy', 'Affiliation': 'Ataturk University School of Medicine, Department of Anesthesiology and Reanimation, Erzurum, Turkey; Ataturk University, Anesthesiology Clinical Research Office, Erzurum, Turkey.'}, {'ForeName': 'Kutsi', 'Initials': 'K', 'LastName': 'Tuncer', 'Affiliation': 'Ataturk University, Anesthesiology Clinical Research Office, Erzurum, Turkey; Ataturk University, School of Medicine, Department of Orthopaedic Surgery, Erzurum, Turkey.'}]",Brazilian journal of anesthesiology (Elsevier),['10.1016/j.bjane.2021.02.044'] 3005,33823205,Comparison of Proseal LMA with i-Gel in children under controlled ventilation: a prospective randomised clinical study.,"BACKGROUND Supraglottic airway device is presently the most common modality of airway management in children for short surgical procedures. The i-gel is one such novel supraglottic airway device with a non-inflatable cuff. The objective of the present study was to evaluate the efficiency of i-gel compared to LMA Proseal regarding oropharyngeal leak pressure, insertion time, ease of insertion, and fibreoptic view of larynx. METHODS After obtaining ethical clearance and parental consent, 70 children aged 2-10 years, weighing 10-30 kg were randomised to receive LMA Proseal or i-gel for airway management. Data with respect to oropharyngeal leak pressure, insertion time, ease of insertion, number of attempts, and fibreoptic score were collected. The primary outcome was the oropharyngeal leak pressure with the two supraglottic airway devices measured by manometric stability. RESULTS Demographic data were comparable between the two groups. The oropharyngeal leak pressure (LMA Proseal vs. i-gel, 20.51 ± 4.71 cmH 2 O vs. 19.57 ± 5.71 cmH 2 O), ease of insertion, number of attempts, and fibreoptic view score was similar between the two groups. The insertion time was faster with i-gel (22.63 ± 5.79 s) compared to LMA Proseal (43.26 ± 7.85 s). CONCLUSION I-gel was similar to LMA Proseal with respect to oropharyngeal leak pressure in children under controlled ventilation.",2021,I-gel was similar to LMA Proseal with respect to oropharyngeal leak pressure in children under controlled ventilation.,"['children for short surgical procedures', 'children under controlled ventilation', '70 children aged 2-10 years, weighing 10-30\u2009kgs']","['LMA Proseal or i-gel for airway management', 'Proseal LMA with i-Gel']","['ease of insertion, number of attempts, and fibreoptic view score', 'oropharyngeal leak pressure', 'insertion time', 'oropharyngeal leak pressure with the two supraglottic airway devices measured by manometric stability', 'oropharyngeal leak pressure, insertion time, ease of insertion, number of attempts, and fibreoptic score', 'oropharyngeal leak pressure, insertion time, ease of insertion, and fibreoptic view of larynx']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0419011', 'cui_str': 'Controlled ventilation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}]","[{'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0150126', 'cui_str': 'Airway management'}]","[{'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0023051', 'cui_str': 'Disorder of the larynx'}]",70.0,0.029861,I-gel was similar to LMA Proseal with respect to oropharyngeal leak pressure in children under controlled ventilation.,"[{'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Shiveshi', 'Affiliation': 'Ramaiah Medical College and Hospitals, Department of Anesthesiology, Karnataka, India.'}, {'ForeName': 'Tejesh Channasandra', 'Initials': 'TC', 'LastName': 'Anandaswamy', 'Affiliation': 'Ramaiah Medical College and Hospitals, Department of Anesthesiology, Karnataka, India. Electronic address: drtejeshca@yahoo.com.'}]",Brazilian journal of anesthesiology (Elsevier),['10.1016/j.bjane.2021.02.042'] 3006,33827452,Nomograms to predict the prognosis in locally advanced oral squamous cell carcinoma after curative resection.,"BACKGROUND Oral squamous cell carcinoma (OSCC) is the dominant histologic type of oral cancer. Locally advanced OSCC remains a major therapeutic challenge. Our study aimed to develop and validate nomograms predicting survival prognosis in patients with locally advanced oral squamous cell carcinoma (OSCC) after curative resection. METHODS A total of 269 consecutive patients with primary OSCC who received curative resection between September 2007 and March 2020 were retrospectively enrolled in our study. Patients were randomly assigned to the training cohort (n = 201) or the validation cohort (n = 68). Multivariate Cox regression analyses were conducted to determine independent prognostic factors for overall survival (OS) and cancer specific survival (CSS) in the training set, which were used to develop nomogram models estimating 3-, and 5-year OS and CSS. We also evaluated the nomograms using concordance indices (c-index), calibration curves, and decision curve analyses (DCA), and compared those with the AJCC 8th staging system. The results were externally validated in the validation cohort. RESULTS Age, Kaplan-Feinstein (KFI) index, pT, the number of positive nodes and systemic inflammatory index (SII) were significant prognostic predictors for OS and CSS. The OS nomogram had c-index values of 0.712 in the training set and 0.697 in the validation set, while the CSS nomogram exhibited c-index values of 0.709 in the training set and 0.675 in the validation set. These data were superior to those of AJCC 8th staging system, suggesting high discriminative ability of the nomograms. Calibration curves exhibited good agreement between observed and predicted survival. DCA curves indicated the nomograms were with potential clinical usefulness. These results were validated in the validation set. CONCLUSIONS The novel nomograms incorporating clinically available characteristics for OS and CSS prediction were developed in the locally advanced OSCC patients after curative surgery. Validation revealed good discrimination and calibration, indicating the clinical utility of the nomograms in the individualized prognosis prediction of locally advanced OSCC after curative surgery.",2021,"The OS nomogram had c-index values of 0.712 in the training set and 0.697 in the validation set, while the CSS nomogram exhibited c-index values of 0.709 in the training set and 0.675 in the validation set.","['locally advanced oral squamous cell carcinoma after curative resection', '269 consecutive patients with primary OSCC who received curative resection between September 2007 and March 2020 were retrospectively enrolled in our study', 'Oral squamous cell carcinoma (OSCC', 'patients with locally advanced oral squamous cell carcinoma (OSCC) after curative resection', 'locally advanced OSCC patients after curative surgery']",[],"['c-index values', 'survival', 'concordance indices (c-index), calibration curves, and decision curve analyses (DCA', 'number of positive nodes and systemic inflammatory index (SII', 'overall survival (OS) and cancer specific survival (CSS']","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",[],"[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0006751', 'cui_str': 'Calibration'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",269.0,0.0730948,"The OS nomogram had c-index values of 0.712 in the training set and 0.697 in the validation set, while the CSS nomogram exhibited c-index values of 0.709 in the training set and 0.675 in the validation set.","[{'ForeName': 'Zhiliang', 'Initials': 'Z', 'LastName': 'Nie', 'Affiliation': 'First Affiliated Hospital of Gannan Medical University, Ganzhou, Jiangxi, China.'}, {'ForeName': 'Pengcheng', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': 'School of Stomatology, Dalian Medical University, Dalian, Liaoning, China.'}, {'ForeName': 'Yishan', 'Initials': 'Y', 'LastName': 'Shang', 'Affiliation': ""Dalian Municipal Women and Children's Medical Center, Dalian, Liaoning, China.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Sun', 'Affiliation': 'The Second Hospital of Dalian Medical University, Dalian, Liaoning, China. sb_dlmy@163.com.'}]",BMC cancer,['10.1186/s12885-021-08106-x'] 3007,33827450,A randomized trial to evaluate the impact of exercise-based cardiac rehabilitation for the prevention of chemotherapy-induced cardiotoxicity in patients with breast cancer: ONCORE study protocol.,"BACKGROUND Anthracyclines and monoclonal antibodies against human epidermal growth factor receptor-2 (HER2) are frequently used to treat breast cancer but they are associated with risk of developing cardiotoxicity. Implementation of cardioprotective strategies as part of breast cancer treatment are needed. To date, a limited number of studies have examined the effectiveness of cardiac rehabilitation programs or exercise programs in the prevention of cardiotoxicity through an integral assessment of cardiac function. The ONCORE study proposes an exercise-based cardiac rehabilitation program as a non-pharmacological tool for the management of chemotherapy-induced cardiotoxicity. METHODS The study protocol describes a prospective, randomized controlled trial aimed to determine whether an intervention through an exercise-based CR program can effectively prevent cardiotoxicity induced by anthracyclines and/or anti-HER2 antibodies in women with breast cancer. Three hundred and forty women with breast cancer at early stages scheduled to receive cardiotoxic chemotherapy will be randomly assigned (1:1) to participation in an exercise-based CR program (intervention group) or to usual care and physical activity recommendation (control group). Primary outcomes include changes in left ventricular ejection fraction and global longitudinal strain as markers of cardiac dysfunction assessed by transthoracic echocardiography. Secondary outcomes comprise levels of cardiovascular biomarkers and cardiopulmonary function through peak oxygen uptake determination, physical performance and psychosocial status. Supervised exercise program-related outcomes including safety, adherence/compliance, expectations and physical exercise in- and out-of-hospital are studied as exploratory outcomes. Transthoracic echocardiography, clinical test and questionnaires will be performed at the beginning and two weeks after completion of chemotherapy. DISCUSSION The growing incidence of breast cancer and the risk of cardiotoxicity derived from cancer treatments demand adjuvant cardioprotective strategies. The proposed study may determine if an exercise-based CR program is effective in minimizing chemotherapy-induced cardiotoxicity in this population of women with early-stage breast cancer. The proposed research question is concrete, with relevant clinical implications, transferable to clinical practice and achievable with low risk. Trial registration ClinicalTrials.gov Identifier: NCT03964142. Registered on 28 May 2019. Retrospectively registered. https://clinicaltrials.gov/ct2/show/NCT03964142.",2021,"The ONCORE study proposes an exercise-based cardiac rehabilitation program as a non-pharmacological tool for the management of chemotherapy-induced cardiotoxicity. ","['women with early-stage breast cancer', 'women with breast cancer', 'Three hundred and forty women with breast cancer at early stages scheduled to receive', 'patients with breast cancer']","['cardiotoxic chemotherapy', 'chemotherapy-induced cardiotoxicity', 'anthracyclines and/or anti-HER2 antibodies', 'exercise-based cardiac rehabilitation program', 'exercise-based cardiac rehabilitation', 'exercise-based CR program (intervention group) or to usual care and physical activity recommendation (control group', 'exercise-based CR program', 'Supervised exercise program']","['levels of cardiovascular biomarkers and cardiopulmonary function through peak oxygen uptake determination, physical performance and psychosocial status', 'cardiotoxicity', 'safety, adherence/compliance, expectations and physical exercise in- and out-of-hospital', 'changes in left ventricular ejection fraction and global longitudinal strain as markers of cardiac dysfunction assessed by transthoracic echocardiography']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0337459', 'cui_str': 'Psychosocial status'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C3277906', 'cui_str': 'Cardiac dysfunction'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}]",340.0,0.0185641,"The ONCORE study proposes an exercise-based cardiac rehabilitation program as a non-pharmacological tool for the management of chemotherapy-induced cardiotoxicity. ","[{'ForeName': 'Estíbaliz', 'Initials': 'E', 'LastName': 'Díaz-Balboa', 'Affiliation': 'Cardiology Department, Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), University Clinical Hospital of Santiago de Compostela (SERGAS), A Choupana s/n, 15706, Santiago de Compostela, A Coruña, Spain. estibaliz.diaz@udc.es.'}, {'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'González-Salvado', 'Affiliation': 'Cardiology Department, Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), University Clinical Hospital of Santiago de Compostela (SERGAS), A Choupana s/n, 15706, Santiago de Compostela, A Coruña, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Rodríguez-Romero', 'Affiliation': 'Psychosocial Intervention and Functional Rehabilitation Research Group, Department of Physiotherapy, Medicine and Biomedical Sciences, Faculty of Physiotherapy, University of A Coruña, A Coruña, Spain.'}, {'ForeName': 'Amparo', 'Initials': 'A', 'LastName': 'Martínez-Monzonís', 'Affiliation': 'Cardiology Department, Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), University Clinical Hospital of Santiago de Compostela (SERGAS), A Choupana s/n, 15706, Santiago de Compostela, A Coruña, Spain.'}, {'ForeName': 'Milagros', 'Initials': 'M', 'LastName': 'Pedreira-Pérez', 'Affiliation': 'Cardiology Department, Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), University Clinical Hospital of Santiago de Compostela (SERGAS), A Choupana s/n, 15706, Santiago de Compostela, A Coruña, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Palacios-Ozores', 'Affiliation': 'Health Research Institute of Santiago de Compostela (IDIS), A Coruña, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'López-López', 'Affiliation': 'Health Research Institute of Santiago de Compostela (IDIS), A Coruña, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Peña-Gil', 'Affiliation': 'Cardiology Department, Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), University Clinical Hospital of Santiago de Compostela (SERGAS), A Choupana s/n, 15706, Santiago de Compostela, A Coruña, Spain.'}, {'ForeName': 'José R', 'Initials': 'JR', 'LastName': 'González-Juanatey', 'Affiliation': 'Cardiology Department, Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), University Clinical Hospital of Santiago de Compostela (SERGAS), A Choupana s/n, 15706, Santiago de Compostela, A Coruña, Spain.'}]",BMC cardiovascular disorders,['10.1186/s12872-021-01970-2'] 3008,33827433,"Identifying and measuring the behavioural, dietary, and physical activity components of weight management consultations delivered by general practice nurses in routine care.","BACKGROUND Many people with obesity receive weight loss consultations by general practice nurses (GPNs) in routine primary care. This exploratory study aimed to characterise the components of these consultations, including behaviour change techniques (BCTs), and dietary and physical activity recommendations. METHODS We analysed audio recordings of weight management consultations conducted by 8 GPNs as part of the 'usual care' group in a randomised controlled trial (ISRCTN75092026). Consultations were coded against three taxonomies to classify BCTs, dietary recommendations, and physical activity recommendations. Associations between coded content and weight loss were assessed. Differences in the content of consultations where weight loss was < 5% or ≥ 5% from baseline weight at 6 months were explored. RESULTS One hundred and fifty audio recordings were available from 53 out of 140 (38%) participants in the usual care group. Participants had on average 3 (SD = 1) recorded consultations over 3 months, lasting 14 (SD = 7) minutes each. Weight change at 3, 6, and 12 months was -3.6% (SD = 4.3), -5.5% (SD = 6.0) and -4.2% (SD = 6.5) for participants with audio recordings. GPNs used 3.9 (SD = 1.6) of 93 BCTs, 3.3 (SD = 2.7) of 30 dietary recommendations and 1.4 (SD = 1.2) of 10 physical activity recommendations per consultation. The most commonly employed BCTs were feedback on outcome of behaviour (80.0%), problem solving (38.0%), and social reward (34.3%). The most common dietary recommendations were about portion size (31.3%), nutrients (28.0%), and balanced diet (19.7%). The main physical activity recommendation was about walking (30.3%). There was no association between weight loss and the number of dietary recommendations, physical activity recommendations, or BCTs used per consultation, or per participant. Social reward was the only technique used significantly more in consultations of participants that lost ≥ 5% of their baseline weight at 6 months. CONCLUSIONS The study provides a new method that could be used to describe the content of weight management consultations. Specific dietary or physical activity recommendations and BCTs were used infrequently and inconsistently in this group of GPNs. Although replication is required in larger samples, this may point to a weakness in current practice.",2021,One hundred and fifty audio recordings were available from 53 out of 140 (38%) participants in the usual care group.,"['One hundred and fifty audio recordings were available from 53 out of 140 (38%) participants in the usual care group', 'people with obesity receive weight loss consultations by general practice nurses (GPNs) in routine primary care']",[],"['behaviour change techniques (BCTs), and dietary and physical activity recommendations', 'Weight change', 'weight loss and the number of dietary recommendations, physical activity recommendations, or BCTs used per consultation, or per participant', 'weight loss', 'Social reward']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]",[],"[{'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}]",150.0,0.0352477,One hundred and fifty audio recordings were available from 53 out of 140 (38%) participants in the usual care group.,"[{'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Tong', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University, of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Morris', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University, of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University, of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Dimitrios A', 'Initials': 'DA', 'LastName': 'Koutoukidis', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University, of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK. dimitrios.koutoukidis@phc.ox.ac.uk.'}]",BMC family practice,['10.1186/s12875-021-01403-1'] 3009,33827421,"Comparative study of magnesium, sodium valproate, and concurrent magnesium-sodium valproate therapy in the prevention of migraine headaches: a randomized controlled double-blind trial.","OBJECTIVE This study aimed to assess the efficacy of concurrent magnesium-sodium valproate therapy and compare it with either magnesium or sodium valproate alone in migraine prophylaxis. MATERIALS AND METHODS This randomized single-center double-blind parallel-group controlled clinical trial study was conducted on migraine patients within the age range of 18-65 years. The subjects with at least four monthly attacks were randomly assigned to group A (n = 82) sodium valproate, group B (n = 70) magnesium with sodium valproate, and group C (n = 70) magnesium. The patients passed a one-month baseline without prophylactic therapy and then received a 3-month treatment. The characteristics of migraine, including frequency, severity, duration of the attacks, and the number of painkillers taken per month, were monthly recorded in each visit. The Migraine Disability Assessment (MIDAS) and Headache Impact Test-6 (HIT-6) scores were recorded at the baseline and after 3 months of treatment in each group. Within- and between-group analyses were performed in this study. RESULTS The obtained results revealed a significant reduction in all migraine characteristics in all groups compared to those reported for the baseline (P <  0.001). Intragroup data analysis indicated that there was no statistically significant difference in headache frequency between groups A and B in the third month (P = 0.525); nevertheless, three other parameters showed a significant reduction in group B, compared to those reported for group A in the third month (P <  0.05). On the other hand, group C could not effectively reduce measured parameters in the patients, compared to groups A and B after 3 months (P <  0.001). Furthermore, the MIDAS and HIT-6 scores significantly diminished in groups A, B, and C compared to those reported at the baseline (P <  0.001), and these changes were more significant in groups A and B than in group C (P <  0.001). CONCLUSION The obtained results of this study revealed that magnesium could enhance the antimigraine properties of sodium valproate in combination therapy and reduce the required valproate dose for migraine prophylaxis.",2021,"Intragroup data analysis indicated that there was no statistically significant difference in headache frequency between groups A and B in the third month (P = 0.525); nevertheless, three other parameters showed a significant reduction in group B, compared to those reported for group A in the third month (P <  0.05).","['migraine patients within the age range of 18-65\u2009years', 'subjects with at least four monthly attacks', 'migraine headaches']","['magnesium or sodium valproate alone', 'magnesium-sodium valproate therapy', 'magnesium with sodium valproate, and group C (n\xa0=\u200970) magnesium', 'sodium valproate', 'magnesium, sodium valproate, and concurrent magnesium-sodium valproate therapy']","['HIT-6) scores', 'migraine characteristics', 'headache frequency', 'frequency, severity, duration of the attacks, and the number of painkillers taken per month', 'Migraine Disability Assessment (MIDAS) and Headache Impact Test-6', 'MIDAS and HIT-6 scores']","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0004063', 'cui_str': 'Assault'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0037567', 'cui_str': 'Valproate sodium'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.21219,"Intragroup data analysis indicated that there was no statistically significant difference in headache frequency between groups A and B in the third month (P = 0.525); nevertheless, three other parameters showed a significant reduction in group B, compared to those reported for group A in the third month (P <  0.05).","[{'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Khani', 'Affiliation': 'Department of Neurology, Neurosciences Research Center (NSRC), Qom University of Medical Sciences, Shahid-Beheshti hospital, Shahid-Beheshti street, Qom, Iran.'}, {'ForeName': 'Seyed Amir', 'Initials': 'SA', 'LastName': 'Hejazi', 'Affiliation': 'Department of Neurology, Neurosciences Research Center (NSRC), Qom University of Medical Sciences, Shahid-Beheshti hospital, Shahid-Beheshti street, Qom, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Yaghoubi', 'Affiliation': 'Cellular and Molecular Research Center, Qom University of Medical Sciences, Qom, Iran.'}, {'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Sharifipour', 'Affiliation': 'Department of Neurology, Neurosciences Research Center (NSRC), Qom University of Medical Sciences, Shahid-Beheshti hospital, Shahid-Beheshti street, Qom, Iran. Sharifipour.e@gmail.com.'}]",The journal of headache and pain,['10.1186/s10194-021-01234-6'] 3010,31616979,Advanced Reconstruction of Vesicourethral Support (ARVUS) during robot-assisted radical prostatectomy: first independent evaluation and review of other factors influencing 1 year continence outcomes.,"PURPOSE Anterior and posterior reconstructions of pelvic structures are used during a robot-assisted radical prostatectomy to obtain better continence outcomes. This study was conducted to evaluate the Advanced Reconstruction of Vesicourethral Support (ARVUS), a novel postprostatectomy reconstruction technique. METHODS The study was designed as a prospective, controlled, partially randomized and blinded experiment. The statistical analysis was based on the generalized linear modeling (GLM) framework with random effects: the logit link was used to model the probability of achieving continence and the logarithmic link was used to evaluate the overall score of the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). The significance of the fixed effects and all possible two-way interactions was tested using the critical level of 0.05. RESULTS The probability of achieving the continence significantly depends on the neurovascular bundle sparing (p < 0.001) and the time after the surgery (p < 0.001). Analogously, the expected ICIQ-SF score significantly depends on the nerve-sparing status (p = 0.035) and the time after the surgery (p < 0.001). No statistically significant difference between the unilateral or bilateral nerve sparing was found. The ARVUS technique seems to perform slightly worse with respect to the expected continence, but this difference is within the margins of random fluctuations (p = 0.715). CONCLUSIONS The study demonstrates a significant positive association between the nerve-sparing approach and the patient's continence, however, regardless of the unilateral or bilateral approach. In terms of the continence rate, no statistically significant benefits of ARVUS were observed.",2020,The probability of achieving the continence significantly depends on the neurovascular bundle sparing (p < 0.001) and the time after the surgery (p < 0.001).,[],"['Vesicourethral Support (ARVUS', 'robot-assisted radical prostatectomy', 'Advanced Reconstruction of Vesicourethral Support (ARVUS']","['Incontinence Questionnaire-Short Form (ICIQ-SF', 'unilateral or bilateral nerve sparing', 'ICIQ-SF score']",[],"[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}]","[{'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0320801,The probability of achieving the continence significantly depends on the neurovascular bundle sparing (p < 0.001) and the time after the surgery (p < 0.001).,"[{'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Kováčik', 'Affiliation': '2nd Urology department of Slovak Medical University, F.D. Roosevelt hospital, Banská Bystrica, Slovakia. viktor.kovacik@gmail.com.'}, {'ForeName': 'Matúš', 'Initials': 'M', 'LastName': 'Maciak', 'Affiliation': 'Department of Probability and Mathematical Statistics, Faculty of Mathematics and Physics, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Vladimír', 'Initials': 'V', 'LastName': 'Baláž', 'Affiliation': '2nd Urology department of Slovak Medical University, F.D. Roosevelt hospital, Banská Bystrica, Slovakia.'}, {'ForeName': 'Jozef', 'Initials': 'J', 'LastName': 'Babeľa', 'Affiliation': '2nd Urology department of Slovak Medical University, F.D. Roosevelt hospital, Banská Bystrica, Slovakia.'}, {'ForeName': 'Viliam', 'Initials': 'V', 'LastName': 'Kubas', 'Affiliation': '2nd Urology department of Slovak Medical University, F.D. Roosevelt hospital, Banská Bystrica, Slovakia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bujdák', 'Affiliation': 'Faculty of Medicine, Slovak Medical University, Bratislava, Slovakia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Beňo', 'Affiliation': 'Department of Vascular Surgery, Central Military and Faculty Hospital, Ružomberok, Slovakia.'}]",World journal of urology,['10.1007/s00345-019-02975-5'] 3011,33266499,The Efficacy of an Energy-Restricted Anti-Inflammatory Diet for the Management of Obesity in Younger Adults.,"There is growing evidence of the dietary impact on obesity-induced low-grade chronic inflammation and the associated chronic non-communicable diseases modification. We determined changes in body composition and cardiometabolic and inflammatory status of participants with obesity after 24 weeks of a dietary intervention based on an energy-reduced anti-inflammatory diet and examined the relationship of these changes with changes in the inflammatory potential of the diet. The anthropometric and body composition parameters of 81 participants (average age of 43 years, 74 women) were assessed. Metabolic status was determined using the glycemic and lipid statuses, and the cardiometabolic index and inflammatory status were determined using the concentration of high-sensitivity C-reactive protein (hs-CRP), interleukin 6 (IL-6), and tumor necrosis factor α (TNF-α). The inflammatory potential of the diet was assessed using the Dietary Inflammatory Index (DII ® ). Intervention with an anti-inflammatory diet resulted in a significant reduction in body weight and visceral adipose tissue and caused improvements in the participants' cardiometabolic and inflammatory statuses. The anti-inflammatory diet was shown to be effective regarding obesity management. The study data could advance current scientific knowledge in the field of inflammation and diet, provide guidelines for obesity management, and find its application in routine clinical practice.",2020,Intervention with an anti-inflammatory diet resulted in a significant reduction in body weight and visceral adipose tissue and caused improvements in the participants' cardiometabolic and inflammatory statuses.,"['participants with obesity after 24 weeks of a', '81 participants (average age of 43 years, 74 women', 'Younger Adults']","['dietary intervention based on an energy-reduced anti-inflammatory diet', 'Energy-Restricted Anti-Inflammatory Diet']","['glycemic and lipid statuses, and the cardiometabolic index and inflammatory status', 'Metabolic status', 'body composition and cardiometabolic and inflammatory status', 'Dietary Inflammatory Index (DII ® ', 'concentration of high-sensitivity C-reactive protein (hs-CRP), interleukin 6 (IL-6), and tumor necrosis factor α (TNF-α', 'body weight and visceral adipose tissue']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0385506', 'cui_str': 'didodecylindocarbocyanine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}]",81.0,0.0115956,Intervention with an anti-inflammatory diet resulted in a significant reduction in body weight and visceral adipose tissue and caused improvements in the participants' cardiometabolic and inflammatory statuses.,"[{'ForeName': 'Gordana', 'Initials': 'G', 'LastName': 'Kenđel Jovanović', 'Affiliation': 'Department of Health Ecology, Teaching Institute of Public Health of Primorsko-goranska County, Krešimirova 52a, 51000 Rijeka, Croatia.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Mrakovcic-Sutic', 'Affiliation': 'Department of Physiology, Immunology and Pathophysiology, Faculty of Medicine, University of Rijeka, Braće Branchetta 20/1, 51000 Rijeka, Croatia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Pavičić Žeželj', 'Affiliation': 'Department of Health Ecology, Teaching Institute of Public Health of Primorsko-goranska County, Krešimirova 52a, 51000 Rijeka, Croatia.'}, {'ForeName': 'Branislav', 'Initials': 'B', 'LastName': 'Šuša', 'Affiliation': 'General Hospital Pula, Santoriova 24a, 52100 Pula, Croatia.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Rahelić', 'Affiliation': 'Vuk Vrhovac University Clinic for Diabetes, Endocrinology and Metabolic Diseases, Merkur University Hospital, Dugi dol 4a, 10000 Zagreb, Croatia.'}, {'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Klobučar Majanović', 'Affiliation': 'Department of Endocrinology, Diabetes and Metabolic Diseases, Clinical Hospital Centre Rijeka, Krešimirova 42, 51000 Rijeka, Croatia.'}]",Nutrients,['10.3390/nu12113583'] 3012,33831980,The effect of spiritual care on quality of life of patients with amputation caused by diabetes type 2: a clinical trial.,"OBJECTIVES This study aimed to investigate effect of a spiritual care on quality of life of patients with amputation caused by diabetes type 2. METHODS The current study was a clinical trial. Fifty four patients with amputation caused by diabetes type 2 referred to Al-Zahra hospital at Isfahan was allocated to two case and control groups. Spiritual care training including transcendental meditation (T.M) technique was established for case group. Participants in case group performed four weeks of meditation technique following participating in sessions of meditation technique training. Data gathering was done using a standard tool to assess quality of life in patients with diabetes (diabetes quality of life: DQOL). Data was analyzed using SPSS software. RESULTS Mean score of quality of life in the four areas of quality of life was not significantly different among case and control groups at baseline, however, mean score of quality of life in case group (2.25 ± 0.56) was significantly better than control group (2.52 ± 0.38) after intervention (p<0.001). CONCLUSIONS Given findings of the study, it seems that spiritual care can improve quality of life of patients with amputation caused by diabetes type 2.",2021,"Mean score of quality of life in the four areas of quality of life was not significantly different among case and control groups at baseline, however, mean score of quality of life in case group (2.25 ± 0.56) was significantly better than control group (2.52 ± 0.38) after intervention (p<0.001). ","['patients with amputation caused by diabetes type 2', 'Fifty four patients with amputation caused by diabetes type 2 referred to Al-Zahra hospital at Isfahan', 'patients with diabetes (diabetes quality of life: DQOL']","['Spiritual care training including transcendental meditation (T.M) technique', 'spiritual care', 'meditation technique following participating in sessions of meditation technique training']","['mean score of quality of life', 'quality of life', 'Mean score of quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]","[{'cui': 'C0150355', 'cui_str': 'Spiritual support'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150814', 'cui_str': 'Transcendental meditation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0080236', 'cui_str': 'Training Technics'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",54.0,0.0368058,"Mean score of quality of life in the four areas of quality of life was not significantly different among case and control groups at baseline, however, mean score of quality of life in case group (2.25 ± 0.56) was significantly better than control group (2.52 ± 0.38) after intervention (p<0.001). ","[{'ForeName': 'Fakhri', 'Initials': 'F', 'LastName': 'Sabouhi', 'Affiliation': 'Nursing and Midwifery Care Research Center, Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mona Joz', 'Initials': 'MJ', 'LastName': 'Mohtashami', 'Affiliation': 'Department of Anesthesiology, School of Allied Medicine, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Mohammadpourhodki', 'Affiliation': 'Kashmar Center of Higher Health Education, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Mahdavi', 'Affiliation': 'Department of Epidemiology, School of Public Health, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Khalili', 'Affiliation': 'Department of Nursing, Arak Branch, Islamic Azad University, Arak, Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Imeni', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Shahroud University of Medical Sciences, Shahroud, Iran.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2020-0211'] 3013,33831632,Uncovering a behavioral strategy for establishing new habits: Evidence from incentives for medication adherence in Uganda.,"Incentives are used to improve many health-related behaviors, but evidence is mixed for their effectiveness both during the incentivization period and, even more so, on the persistence of the behavior after incentives are withdrawn. In this paper, we present the results of a randomized controlled trial that successfully uses incentives to improve medication adherence among HIV-infected patients in Uganda over 20 months, and follows the sample for another 6 months to measure the persistence of these behavioral improvements. Our study contributes to the literature on habit formation by identifying a behavioral strategy that is associated with persistently high medication adherence after controlling for observable individual-level characteristics and the receipt of incentives. We find evidence supporting a psychological theory of habits as reflexive context-behavior associations, which suggests new ways of designing incentive-based interventions for better promoting persistent, healthier behaviors.",2021,Our study contributes to the literature on habit formation by identifying a behavioral strategy that is associated with persistently high medication adherence after controlling for observable individual-level characteristics and the receipt of incentives.,"['Uganda', 'HIV-infected patients in Uganda over 20 months']",[],['medication adherence'],"[{'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",[],"[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",,0.0588831,Our study contributes to the literature on habit formation by identifying a behavioral strategy that is associated with persistently high medication adherence after controlling for observable individual-level characteristics and the receipt of incentives.,"[{'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Stecher', 'Affiliation': 'Arizona State University, 500 N 3rd Street, Phoenix, AZ 85004, United States. Electronic address: chad.stecher@asu.edu.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Mukasa', 'Affiliation': 'Mildmay Uganda, Kampala, Uganda. Electronic address: barbara.mukasa@mildmay.or.ug.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Linnemayr', 'Affiliation': 'RAND Corporation, 1776 Main Street, Santa Monica, CA 90401, United States. Electronic address: Sebastian.Linnemayr@rand.org.'}]",Journal of health economics,['10.1016/j.jhealeco.2021.102443'] 3014,33831504,Effectiveness of silicone-based resilient denture liners on masticatory function: A randomised controlled trial.,"OBJECTIVES This randomised controlled trial aimed to compare the masticatory function between the silicone-based resilient denture liner and conventional denture among edentulous patients. METHODS The trial included edentulous patients who were willing to have a new set of complete dentures. Participants were randomly assigned to receive mandibular complete dentures with either a 1) conventional denture base (CD group) or (2) silicone-based resilient denture liner (RD group). Masticatory performance (evaluated with gummy jelly) and the maximum occlusal force were measured at baseline, on final adjustment, and at 3 months after the final adjustment. The outcomes were analyzed using two-way mixed analysis of variance and a paired t-test. The statistical significance was set at p < 0.05. RESULTS The masticatory performance was lower in the RD group than in the CD group; it increased significantly over time in the CD group, but not in the RD group. The maximum occlusal force in the RD group was significantly higher than that in the CD group; it increased significantly over time in the RD group, but not in the CD group. CONCLUSIONS Silicone-based RD liners applied to mandibular complete dentures are effective in improving the maximum occlusal force but not the masticatory performance, as measured with gummy jelly. CLINICAL SIGNIFICANCE Prior evidence has suggested that mandibular complete dentures with resilient denture liners improve masticatory function. However, the results of this study indicate that difficulties may remain with the mastication of foods with a certain texture (e.g., gummy jelly).",2021,"The masticatory performance was lower in the RD group than in the CD group; it increased significantly over time in the CD group, but not in the RD group.","['edentulous patients', 'edentulous patients who were willing to have a new set of complete dentures']","['Silicone-based RD liners', 'mandibular complete dentures with either a 1) conventional denture base (CD group) or (2) silicone-based resilient denture liner (RD group', 'silicone-based resilient denture liner and conventional denture', 'silicone-based resilient denture liners']","['Masticatory performance', 'maximum occlusal force', 'masticatory performance', 'masticatory function']","[{'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0011455', 'cui_str': 'Complete denture'}]","[{'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0181663', 'cui_str': 'Liner'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0011455', 'cui_str': 'Complete denture'}, {'cui': 'C0457285', 'cui_str': 'Conventional denture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011450', 'cui_str': 'Cushion Liners'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0005654', 'cui_str': 'Masticatory Force'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.0516287,"The masticatory performance was lower in the RD group than in the CD group; it increased significantly over time in the CD group, but not in the RD group.","[{'ForeName': 'Yoshiteru', 'Initials': 'Y', 'LastName': 'Furuya', 'Affiliation': 'Nihon University Graduate School of Dentistry at Matsudo, Removable Prosthodontics, Matsudo, Japan. Electronic address: mayo18014@g.nihon-u.ac.jp.'}, {'ForeName': 'Suguru', 'Initials': 'S', 'LastName': 'Kimoto', 'Affiliation': 'Department of Removable Prosthodontics, Nihon University School of Dentistry at Matsudo, Matsudo, Japan.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Furuse', 'Affiliation': 'Department of Removable Prosthodontics, Nihon University School of Dentistry at Matsudo, Matsudo, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Igarashi', 'Affiliation': 'Department of Removable Prosthodontics, Nihon University School of Dentistry at Matsudo, Matsudo, Japan.'}, {'ForeName': 'So', 'Initials': 'S', 'LastName': 'Furokawa', 'Affiliation': 'Department of Removable Prosthodontics, Nihon University School of Dentistry at Matsudo, Matsudo, Japan.'}, {'ForeName': 'Yasuhiko', 'Initials': 'Y', 'LastName': 'Kawai', 'Affiliation': 'Department of Removable Prosthodontics, Nihon University School of Dentistry at Matsudo, Matsudo, Japan.'}]",Journal of dentistry,['10.1016/j.jdent.2021.103657'] 3015,33835175,Effectiveness of a Culturally Tailored HIV and Sexually Transmitted Infection Prevention Intervention for Black Women in Community Supervision Programs: A Randomized Clinical Trial.,"Importance Concentrated epidemics of HIV and sexually transmitted infections (STIs) have persisted among Black women in community supervision programs (CSPs) in the United States. Accumulating research has highlighted the effectiveness of culturally tailored HIV/STI interventions for Black women; however, there is a dearth of such interventions for the large number of Black women in CSPs. Objective To determine the effectiveness of a 5-session culturally tailored group-based intervention (Empowering African-American Women on the Road to Health [E-WORTH]) with individualized computerized modules and streamlined HIV testing in reducing STIs and condomless sex vs a 1-session streamlined HIV testing control condition. Design, Setting, and Participants This randomized clinical trial was conducted from November 18, 2015, (first recruitment) to August 20, 2019 (last 12-month follow-up). Black women mandated to probation, parole, or alternative-to-incarceration programs in New York City who had a history of drug use were recruited and randomized to receive either E-WORTH or a streamlined HIV testing control condition. Both conditions were delivered by Black female staff at a large CSP. The analysis took an intention-to-treat approach. Intervention E-WORTH included a 1-hour individual HIV testing and orientation session and 4 weekly 90-minute group sessions. The control condition included one 30-minute session of HIV testing and information. Main Outcomes and Measures Primary outcomes were incidence of any STI (biologically assayed chlamydia, gonorrhea, and Trichomonas vaginalis) at the 12-month assessment and the number of condomless acts of vaginal or anal intercourse in the past 90 days during the 12-month period. Results A total of 352 participants who identified as Black or African American were enrolled, including 79 (22.5%) who also identified as Latinx. The mean (SD) age was 32.4 (11.0) years. A total of 172 participants (48.9%) were assigned to the E-WORTH condition, and 180 (51.1%) were assigned to the control condition. Compared with control participants, participants assigned to the E-WORTH condition had 54% lower odds of testing positive for any STI at the 12-month follow-up (odds ratio, 0.46; 95% CI, 0.25-0.88; P = .01) and reported 38% fewer acts of condomless vaginal or anal intercourse during the 12-month period (incidence rate ratio, 0.62; 95% CI, 0.39-0.97; P = .04). Conclusions and Relevance The magnitudes of effects found across biological and behavioral outcomes in this randomized clinical trial indicate the feasibility and effectiveness of implementing E-WORTH in real-world CSPs. The findings lend further evidence to the promise of culturally tailored HIV/STI interventions for Black women. Trial Registration ClinicalTrials.gov Identifier: NCT02391233.",2021,"Importance Concentrated epidemics of HIV and sexually transmitted infections (STIs) have persisted among Black women in community supervision programs (CSPs) in the United States.","['November 18, 2015, (first recruitment) to August 20, 2019 (last 12-month follow-up', 'A total of 172 participants (48.9%) were assigned to the E-WORTH condition, and 180 (51.1', 'Black women in community supervision programs (CSPs) in the United States', '352 participants who identified as Black or African American were enrolled, including 79 (22.5%) who also identified as Latinx', 'Black women mandated to probation, parole, or alternative-to-incarceration programs in New York City who had a history of drug use', 'Black Women in Community Supervision Programs', 'Black women']","['Culturally Tailored HIV and Sexually Transmitted Infection Prevention Intervention', '5-session culturally tailored group-based intervention', 'E-WORTH', 'individualized computerized modules and streamlined HIV testing']","['condomless vaginal or anal intercourse', 'incidence of any STI (biologically assayed chlamydia, gonorrhea, and Trichomonas vaginalis) at the 12-month assessment and the number of condomless acts of vaginal or anal intercourse']","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517649', 'cui_str': '22.5'}, {'cui': 'C0205255', 'cui_str': 'Imprisonment'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0556628', 'cui_str': 'Anal penetration'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0205460', 'cui_str': 'Biologic'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0018081', 'cui_str': 'Gonorrhea'}, {'cui': 'C0040922', 'cui_str': 'Trichomonas vaginalis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}]",352.0,0.213925,"Importance Concentrated epidemics of HIV and sexually transmitted infections (STIs) have persisted among Black women in community supervision programs (CSPs) in the United States.","[{'ForeName': 'Louisa', 'Initials': 'L', 'LastName': 'Gilbert', 'Affiliation': 'Social Intervention Group, Columbia University School of Social Work, New York, New York.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Goddard-Eckrich', 'Affiliation': 'Social Intervention Group, Columbia University School of Social Work, New York, New York.'}, {'ForeName': 'Mingway', 'Initials': 'M', 'LastName': 'Chang', 'Affiliation': 'Social Intervention Group, Columbia University School of Social Work, New York, New York.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Hunt', 'Affiliation': 'Social Intervention Group, Columbia University School of Social Work, New York, New York.'}, {'ForeName': 'Elwin', 'Initials': 'E', 'LastName': 'Wu', 'Affiliation': 'Social Intervention Group, Columbia University School of Social Work, New York, New York.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Johnson', 'Affiliation': 'University of Alabama School of Social Work, Tuscaloosa.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Richards', 'Affiliation': 'Fortune Society, Long Island City, New York.'}, {'ForeName': 'Sharun', 'Initials': 'S', 'LastName': 'Goodwin', 'Affiliation': 'New York City Department of Probation, New York, New York.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Tibbetts', 'Affiliation': 'New York City Department of Probation, New York, New York.'}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Metsch', 'Affiliation': 'Sociomedical Sciences, Mailman School of Public Health, Columbia University, New York, New York.'}, {'ForeName': 'Nabila', 'Initials': 'N', 'LastName': 'El-Bassel', 'Affiliation': 'Social Intervention Group, Columbia University School of Social Work, New York, New York.'}]",JAMA network open,['10.1001/jamanetworkopen.2021.5226'] 3016,33835016,"Pharmacokinetics of oral pridinol: Results of a randomized, crossover bioequivalence trial in healthy subjects.","OBJECTIVES To establish the relative bioavailability and to assess bioequivalence of oral, immediate-release tablets containing pridinol and to determine the pharmacokinetic properties of the compound. METHODS AND MATERIALS In this single-center, open-label, randomized, crossover trial, healthy male and female adult subjects received single doses of the test and reference product containing 4 mg pridinol mesylate (equivalent to 3 mg pridinol) each under fasting conditions. For pharmacokinetic evaluation, blood samples were withdrawn until 72 hours post dose. Pridinol in plasma was quantified by validated liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS). Adverse events (AEs) were analyzed descriptively. RESULTS Of 34 randomized subjects, 33 completed all treatments. The determined pharmacokinetic parameters were quite similar for both products, with geometric means for maximum exposure (C max ) of 29.27 ng/mL (test) and 27.44 ng/mL (reference), reached after 1.00 and 0.90 hours (mean t max ), respectively. The extents of bioavailability (geometric mean AUC 0-tlast ) were 187.93 h×ng/mL (test) and 183.51 h×ng/mL (reference). Elimination half-lives (T 1/2 ) ranged from 8.97 to 34.85 hours with comparable mean T 1/2 of 19.14 hours (test) and 18.85 hours (reference). The point estimates of the test/reference-adjusted geometric mean ratios of AUC 0-tlast , C max (primary), and AUC 0-∞ (secondary) were 102.54% (90% confidence interval: 96.19 - 109.32%), 106.79% (99.00 - 115.20%), and 102.60% (96.20 - 109.43%), respectively. Overall, 23 subjects experienced 50 AEs; headache and dizziness (15 cases each) were most frequently reported. CONCLUSION Bioequivalence of both pridinol products was demonstrated in terms of rate and extent of absorption. Safety and tolerability were in accordance with the known AE profile of the drug substance.",2021,The extents of bioavailability (geometric mean AUC 0-tlast ) were 187.93 h×ng/mL (test) and 183.51 h×ng/mL (reference).,"['healthy male and female adult subjects', 'healthy subjects', '34 randomized subjects']","['oral pridinol', 'reference product containing 4 mg pridinol mesylate (equivalent to 3 mg pridinol) each under fasting conditions']","['Safety and tolerability', 'rate and extent of absorption', 'test/reference-adjusted geometric mean ratios of AUC 0-tlast , C max (primary), and AUC 0-∞', 'extents of bioavailability (geometric mean AUC 0-tlast ', 'Adverse events (AEs', '50 AEs; headache and dizziness']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0071968', 'cui_str': 'pridinol'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0138377', 'cui_str': 'pridinol monomesylate'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",34.0,0.142241,The extents of bioavailability (geometric mean AUC 0-tlast ) were 187.93 h×ng/mL (test) and 183.51 h×ng/mL (reference).,"[{'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Richter', 'Affiliation': ''}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Donath', 'Affiliation': ''}, {'ForeName': 'Ralph-Steven', 'Initials': 'RS', 'LastName': 'Wedemeyer', 'Affiliation': ''}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Warnke', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Horstmann', 'Affiliation': ''}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Peschel', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP203900'] 3017,33834863,"Exploring the Safety, Effectiveness, and Cost-Effectiveness of a Chinese Patent Medicine (Fufang E'jiao Syrup) for Alleviating Cancer-Related Fatigue: A Protocol for a Randomized, Double-Blinded, Placebo-Controlled, Multicenter Trial.","OBJECTIVE To provide higher level evidence on the benefits of a Chinese patent medicine (CPM) (Fufang E'jiao Syrup, FFEJS) for alleviating cancer-related fatigue (CRF), this article describes a protocol for a randomized controlled trial. METHODS/DESIGN We designed a double-blind, placebo-controlled stratified permuted block randomization clinical trial on CRF among 3 types of cancer in China. Participants will be equally allocated to FFEJS group or placebo group according to the randomization sequence and the hospitals they were enrolled at. Each patient will receive 20 ml of either the study formula FFEJS or a placebo formula, 3 times a day for 6 weeks. The follow-up period will be another 4 weeks for safety evaluation. The primary outcome is the difference in improvement of fatigue as measured with the Revised Piper Fatigue Scale-Chinese Version (RPFS-CV). Secondary outcomes include change in fatigue (measured by routine blood panel and hormones in peripheral blood) and QoL (measured by Edmonton symptom assessment scale and Functional Assessment of Cancer Therapy). Patient safety will be measured by liver, renal or cardiac damage, and the risk of FFEJS having a tumor promotion and progression effect will be monitored throughout this study. Cost-effectiveness will also be evaluated mainly by incremental cost per each quality-adjusted life year gained. DISCUSSION This article describes the study design of a CPM for CRF in patients with advanced cancer through exploring the effectiveness, safety, and cost-effectiveness of FFEJS. TRIAL REGISTRATION ClinicalTrials.gov, NCT04147312. Registered on 1 Sep 2019.",2021,The primary outcome is the difference in improvement of fatigue as measured with the Revised Piper Fatigue Scale-Chinese Version (RPFS-CV).,"['CRF among 3 types of cancer in China', 'patients with advanced cancer', 'Alleviating Cancer-Related Fatigue', 'group according to the randomization sequence and the hospitals they were enrolled at']","['CPM', ""Chinese patent medicine (CPM) (Fufang E'jiao Syrup, FFEJS"", ""Chinese Patent Medicine (Fufang E'jiao Syrup"", 'placebo', 'FFEJS', 'Placebo']","['alleviating cancer-related fatigue (CRF', 'change in fatigue (measured by routine blood panel and hormones in peripheral blood) and QoL (measured by Edmonton symptom assessment scale and Functional Assessment of Cancer Therapy', 'improvement of fatigue as measured with the Revised Piper Fatigue Scale-Chinese Version (RPFS-CV', 'Safety, Effectiveness, and Cost-Effectiveness', 'Cost-effectiveness']","[{'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013231', 'cui_str': 'Drugs, Non-Prescription'}, {'cui': 'C4308296', 'cui_str': 'colla corii asini'}, {'cui': 'C0458173', 'cui_str': 'Syrup'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0330232', 'cui_str': 'Piper'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.792639,The primary outcome is the difference in improvement of fatigue as measured with the Revised Piper Fatigue Scale-Chinese Version (RPFS-CV).,"[{'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Song', 'Affiliation': 'Xiyuan Hospital of Chinese Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Ling-Yun', 'Initials': 'LY', 'LastName': 'Sun', 'Affiliation': 'Xiyuan Hospital of Chinese Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Shan-Shan', 'Initials': 'SS', 'LastName': 'Gu', 'Affiliation': 'Xiyuan Hospital of Chinese Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Xiao-Shu', 'Initials': 'XS', 'LastName': 'Zhu', 'Affiliation': 'Western Sydney University, Penrith, NSW, Australia.'}, {'ForeName': 'He-Zheng', 'Initials': 'HZ', 'LastName': 'Lai', 'Affiliation': 'Western Sydney University, Penrith, NSW, Australia.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Lu', 'Affiliation': 'Institution of Clinical Pharmacology, Xiyuan Hospital of Chinese Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Cui', 'Affiliation': 'Xiyuan Hospital of Chinese Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Qiong-Yang', 'Initials': 'QY', 'LastName': 'Li', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine affiliated with Capital Medical University, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Xiyuan Hospital of Chinese Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Xiyuan Hospital of Chinese Academy of Chinese Medical Sciences, Beijing, China.'}]",Integrative cancer therapies,['10.1177/15347354211002919'] 3018,33833804,Debris Extrusion Using Reciproc Blue and XP Endo Shaper Systems in Root Canal Retreatment.,"This study aimed at assessing the performance of Reciproc Blue (RB) and XP Endo Shaper (XPS), used for canal retreatment on extracted teeth, in terms of debris extrusion and obturating materials removal. Thirty mandibular premolars were prepared to ProTaper X2 file, obturated using warm vertical compaction, and then incubated for 28 days at 100% humidity at 37°C. Teeth were randomly assigned into two groups, according to the system used for retreatment (RB and XPS). During retreatment, debris extruded beyond the apex was collected in preweighed Eppendorf tubes, and the retreatment time was measured. Afterward, the teeth were longitudinally sectioned to assess the remaining obturating materials. Data were statistically analyzed using the Mann-Whitney test and chi-square test at a 95% confidence level. All the samples had extruded debris at varying weights ranging from 0.125 mg to 3.680 mg. XPS extruded less debris than RB, but no difference was detected (Mann-Whitney test; P > 0.05). RB and XPS required 54.9 ± 17.9 and 22.3 ± 9.3 seconds to perform retreatment procedures, respectively (Mann-Whitney test; P < 0.05). The sealer was found in all the samples. Compared to the RB group, fewer samples with remaining gutta-percha were found in the XPS group (Chi-square test; P < 0.05). None of the files fractured during the retreatment procedure. The tested files appear to extrude debris beyond the apex. Although XPS was able to remove the gutta-percha completely from the majority of the canals, it was unable to remove the sealer.",2021,"XPS extruded less debris than RB, but no difference was detected (Mann-Whitney test; P > 0.05).",['Thirty mandibular premolars'],"['Reciproc Blue (RB) and XP Endo Shaper (XPS', 'XPS']",[],"[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}]","[{'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}]",[],,0.0322912,"XPS extruded less debris than RB, but no difference was detected (Mann-Whitney test; P > 0.05).","[{'ForeName': 'Taher', 'Initials': 'T', 'LastName': 'AlOmari', 'Affiliation': 'Department of Conservative Dentistry, Faculty of Dentistry, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Ruba', 'Initials': 'R', 'LastName': 'Mustafa', 'Affiliation': 'Department of Conservative Dentistry, Faculty of Dentistry, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Al-Fodeh', 'Affiliation': 'Department of Prosthetic Dentistry, Faculty of Dentistry, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Hamza', 'Initials': 'H', 'LastName': 'El-Farraj', 'Affiliation': 'Department of Conservative Dentistry, Faculty of Dentistry, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Waheeb', 'Initials': 'W', 'LastName': 'Khaled', 'Affiliation': 'Department of Conservative Dentistry, Faculty of Dentistry, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Jamleh', 'Affiliation': 'Department of Restorative and Prosthetic Sciences, College of Dentistry, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.'}]",International journal of dentistry,['10.1155/2021/6697587'] 3019,33833179,The Effect of Vibration on Pain During Intravenous Injection of Propofol: A Randomized Controlled Trial.,"PURPOSE Pain is a common side effect of intravenous injection of propofol. We conducted a randomized, prospective, single-blinded controlled trial to assess the efficacy of vibration analgesia on pain during propofol infusion in ambulatory surgery. METHODS After institutional review board approval, 100 patients undergoing elective ambulatory surgery with general anesthesia were randomized into 2 groups. A control group (n = 50) consisted of patients who received infusion of propofol without vibration analgesia. A treatment group (n = 50) consisted of patients who received infusion of propofol with vibration analgesia using the Buzzy device. Pain was assessed using a 4-point pain manifestation scale scored by 2 independent, blinded observers. RESULTS Participants in the treatment group with vibration analgesia were 0.47 times less likely (95% confidence interval, 0.24-0.94; P = 0.03) to experience any pain than the control group. The median summative pain score in the treatment group was significantly less than that of the control group [1 (interquartile range, 1-2) vs 2 (interquartile range, 2-4); P < 0.01] among participants who experienced any pain. Agreement between the 2 blinded observers regarding pain scores was excellent with κw = 0.82 (P < 0.001). Age, sex, body mass index, needle location or size, and medication doses did not differ significantly between the 2 groups. CONCLUSION Vibration analgesia is an effective, low-risk modality that reduces the pain of intravenous propofol injection in general anesthesia.",2021,Agreement between the 2 blinded observers regarding pain scores was excellent with κw = 0.82,['100 patients undergoing elective ambulatory surgery with general anesthesia'],"['Vibration', 'Vibration analgesia', 'propofol infusion', 'Propofol', 'propofol', 'propofol without vibration analgesia', 'propofol with vibration analgesia using the Buzzy device', 'vibration analgesia']","['pain', 'Pain', 'median summative pain score', 'pain scores', '4-point pain manifestation scale', 'vibration analgesia']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0002428', 'cui_str': 'Ambulatory surgery'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",100.0,0.198721,Agreement between the 2 blinded observers regarding pain scores was excellent with κw = 0.82,"[{'ForeName': 'Lyahn K', 'Initials': 'LK', 'LastName': 'Hwang', 'Affiliation': 'From the Division of Plastic Surgery Department of Anesthesiology, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Nash', 'Affiliation': ''}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Yedlin', 'Affiliation': ''}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Greige', 'Affiliation': ''}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'Larios-Valencia', 'Affiliation': ''}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Choice', 'Affiliation': ''}, {'ForeName': 'Aravind', 'Initials': 'A', 'LastName': 'Pothula', 'Affiliation': ''}]",Annals of plastic surgery,['10.1097/SAP.0000000000002827'] 3020,33832537,FASTER and SCOTT&EVA trainings for adults with high-functioning autism spectrum disorder (ASD): study protocol for a randomized controlled trial.,"BACKGROUND Autism spectrum disorder (ASD) is a chronic neurodevelopmental condition with a prevalence rate above 1%, characterized by deficits in social communication and interaction; restrictive, repetitive patterns of behavior, interests, or activities; and a preference for sameness and routines. The majority of adult ASD patients suffer from comorbid conditions such as depression and anxiety. Therapy options for adult ASD patients are lacking, with presently no available evidence-based interventions in Germany. Recently, two interventions to improve social responsiveness have been published. FASTER (""Freiburger Asperger-Spezifische Therapie für ERwachsene"" = Freiburg Asperger-specific therapy for adults) is a manualized group psychotherapy program including three modules on psychoeducation, stress regulation management, and non-verbal and verbal social communication training with videotaped tasks. SCOTT&EVA (""Social Cognition Training Tool"", and its enhancement ""Emotionen Verstehen und Ausdruecken"" = understanding and expressing emotions) is a computer-based training program to enhance social cognition including video and audio material of emotional expressions and complex real-life social situations. Initial studies for both programs have shown good feasibility and efficacy. METHODS Three hundred sixty adult participants with an autism spectrum disorder (ASD) will take part in a randomized controlled three-armed multi-center trial to prove the efficacy of manualized group psychotherapy and a manualized computer-based training program. Both interventions will be compared with a treatment as usual (TAU) group, aiming to establish evidence-based psychotherapy approaches for adult individuals with ASD. The primary outcome is evaluated by parents, spouses, or others who have sufficient insight into the respective participant's social communication and interaction, and will be measured with the Social Responsiveness Scale. First, each of both interventions will be compared to TAU. If at least one of the differences is significant, both interventions will be compared against each other. The primary outcome will be measured at baseline (T0) and 4 months after baseline (T1). DISCUSSION The trial is the first to validate psychiatric therapeutic and training interventions for adult ASD patients in Germany. A trial is needed because the prevalence of ASD in adulthood without intellectual disability is high, and no evidence-based intervention can be offered in Germany. TRIAL REGISTRATION German Clinical Trial Register DRKS00017817 . Registered on 20 April 2020.",2021,"Both interventions will be compared with a treatment as usual (TAU) group, aiming to establish evidence-based psychotherapy approaches for adult individuals with ASD.","['Autism spectrum disorder (ASD', 'adult ASD patients', 'adult individuals with ASD', 'Three hundred sixty adult participants with an autism spectrum disorder (ASD', 'Freiburg Asperger-specific therapy for adults', 'adult ASD patients in Germany', 'adults with high-functioning autism spectrum disorder (ASD']","['manualized group psychotherapy program including three modules on psychoeducation, stress regulation management, and non-verbal and verbal social communication training with videotaped tasks', 'manualized group psychotherapy and a manualized computer-based training program']","[""respective participant's social communication and interaction, and will be measured with the Social Responsiveness Scale""]","[{'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0236792', 'cui_str': ""Asperger's disorder""}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C3840214', 'cui_str': 'High-functioning autism'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",360.0,0.067821,"Both interventions will be compared with a treatment as usual (TAU) group, aiming to establish evidence-based psychotherapy approaches for adult individuals with ASD.","[{'ForeName': 'Ludger', 'Initials': 'L', 'LastName': 'Tebartz van Elst', 'Affiliation': 'Department of Psychiatry and Psychotherapy Medical Center, University of Freiburg Faculty of Medicine, Freiburg im Breisgau, Germany. tebartzvanelst@uniklinik-freiburg.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Fangmeier', 'Affiliation': 'Department of Psychiatry and Psychotherapy Medical Center, University of Freiburg Faculty of Medicine, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Ulrich Max', 'Initials': 'UM', 'LastName': 'Schaller', 'Affiliation': 'Department of Psychiatry and Psychotherapy Medical Center, University of Freiburg Faculty of Medicine, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Hennig', 'Affiliation': 'Central Institute for Mental Health, Mannheim, Germany.'}, {'ForeName': 'Meinhard', 'Initials': 'M', 'LastName': 'Kieser', 'Affiliation': 'Institute of Medical Biometry and Informatics, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Koelkebeck', 'Affiliation': 'Department of Psychiatry and Psychotherapy, LVR-Hospital Essen, Medical Faculty, University of Duisburg-Essen, Duisburg, Germany.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Kuepper', 'Affiliation': 'Department of Psychology, Berlin School of Mind and Brain, Humboldt-Universitaet zu Berlin, Berlin, Germany.'}, {'ForeName': 'Veit', 'Initials': 'V', 'LastName': 'Roessner', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, Faculty of Medicine, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Wildgruber', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tuebingen, Tübingen, Germany.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Dziobek', 'Affiliation': 'Department of Psychology, Berlin School of Mind and Brain, Humboldt-Universitaet zu Berlin, Berlin, Germany.'}]",Trials,['10.1186/s13063-021-05205-9'] 3021,33247395,"The use of interactive distraction technique to manage gagging during impression taking in children: a single-blind, randomised controlled trial.","PURPOSE To evaluate the effect of interactive distraction technique on the severity of gagging and success of impression taking in children between age 5 and 10 years. METHODS This single blind, randomised controlled trial recruited 48 children aged 5-10 years requiring maxillary impressions. Selected children were randomly allocated to one of the two groups: (1) Test group, use of interactive distraction, and (2) Control group, no use of interactive distraction, during impression taking. Dental anxiety was scored using Facial Image Scale (FIS) before and after impression taking. Gagging-related Impression Success Scale (GISS) and Gagging Severity Index (GSI) were recorded by a blinded assessor. Nonparametric tests were used to compare the variables between the groups. RESULTS Maxillary impressions were successfully recorded in all children in the Test group; either with no gag (87.5%) or with gag (12.5%). In 33.3% control children impressions could not be recorded. Statistically significant, strong association was found between the interactive distraction and GISS (p = 0.003, Cramer's V = 0.32). Mean GSI and post-impression FIS scores were significantly lesser in the Test group (p = 0.029 and p = 0.048, respectively). Significant increase in the mean FIS scores was observed after recording impression in the Control group. Post-impression FIS showed significant positive correlation with GSI (Test: p = 0.003, Control: p = 0.009) and significant inverse correlation with GISS (Test: p = 0.003, Control: p = 0.01). CONCLUSION Interactive distraction technique used in this study is a simple, non-invasive and cost-effective method to effectively manage gagging and successfully record a maxillary impression in children between age 5 and 10 years.",2021,Post-impression FIS showed significant positive correlation with GSI,"['children', 'children between age 5 and 10\xa0years', '48 children aged 5-10\xa0years requiring maxillary impressions']","['Interactive distraction technique', 'GSI', 'interactive distraction, and (2) Control group, no use of interactive distraction', 'interactive distraction technique']","['mean FIS scores', 'interactive distraction and GISS', 'Dental anxiety', 'severity of gagging and success of impression taking', 'Gagging-related Impression Success Scale (GISS) and Gagging Severity Index (GSI', 'Mean GSI and post-impression FIS scores', 'Facial Image Scale (FIS']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}]","[{'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0016927', 'cui_str': 'Gagging'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1524063', 'cui_str': 'Use of'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0016927', 'cui_str': 'Gagging'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0085380', 'cui_str': 'Dental phobia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0687676', 'cui_str': 'After values'}]",48.0,0.0513774,Post-impression FIS showed significant positive correlation with GSI,"[{'ForeName': 'U B', 'Initials': 'UB', 'LastName': 'Dixit', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, DY Patil University-School of Dentistry, Sector 7, Nerul, Navi Mumbai, India. umadixit2000@yahoo.com.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Moorthy', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, DY Patil University-School of Dentistry, Sector 7, Nerul, Navi Mumbai, India.'}]",European archives of paediatric dentistry : official journal of the European Academy of Paediatric Dentistry,['10.1007/s40368-020-00582-2'] 3022,33246896,Evaluation of a web-based virtual nursing intervention to support self-management among adults with epilepsy: A mixed-methods study.,"OBJECTIVE A web-based intervention was developed to support epilepsy self-management. A mixed methods study was undertaken to evaluate the intervention's extent of utilization, acceptability and preliminary effects, and to assess user perception of it. METHODS First, a pilot parallel-group randomized controlled trial was conducted with a convenience sample of 75 adult with epilepsy who had Internet access allocated on a 1:1 ratio into an experimental group that received the intervention (experimental group (EG), n = 37) and a control group invited to consult epilepsy-related websites (control group (CG), n = 38). Self-management, knowledge, and quality of life (QoL) outcomes were measured at baseline and one and three months later. Descriptive statistics of extent of utilization and acceptability were computed. Linear mixed models were conducted to assess change in outcomes over time and between groups. Subsequently, an exploratory qualitative study was carried out with 15 EG participants. Qualitative data were subjected to thematic analysis. RESULTS Participants had a mean age of 40 years (range: 18-73), 45% were female, and mean time since diagnosis was 18 years (range: less than a year to 60 years). In the EG, 70% of the participants completed the intervention. Regarding acceptability, participants (n = 25) were satisfied overall (88%) and found content clear (92%) and the information reliable (100%). EG participants experienced greater improvement in QoL compared with CG participants, least-squares means (95% CI): 0.41 (0.06, 0.76). Three major themes emerged from the interviews (n = 15): intervention provides certain personal benefits; clinical content is of general interest but should be tailored; and intervention should target ""new"" patients early in the care trajectory. DISCUSSION The web-based intervention shows promise in terms of usefulness in enhancing QoL, and user experience showed that it is acceptable and helpful. It could constitute a complementary service in support of existing services for people with epilepsy and their families.",2021,"EG participants experienced greater improvement in QoL compared with CG participants, least-squares means (95% CI):","['people with epilepsy and their families', 'Participants had a mean age of 40\u202fyears (range: 18-73), 45% were female, and mean time since diagnosis was 18\u202fyears (range', 'adults with epilepsy', '75 adult with epilepsy who had Internet access allocated on a 1:1 ratio into an experimental group that received the']","['intervention (experimental group (EG), n\u202f=\u202f37) and a control group invited to consult epilepsy-related websites (control group (CG', 'web-based virtual nursing intervention']","['QoL', 'Self-management, knowledge, and quality of life (QoL) outcomes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4704731', 'cui_str': 'Internet Access'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",75.0,0.106141,"EG participants experienced greater improvement in QoL compared with CG participants, least-squares means (95% CI):","[{'ForeName': 'José', 'Initials': 'J', 'LastName': 'Côté', 'Affiliation': ""Research Chair in Innovative Nursing Practices, 850 rue St-Denis, Montreal, Quebec H2X 0A9, Canada; Research Centre of the Centre Hospitalier de l'Université de Montréal, 850 rue St-Denis, Montreal, Quebec H2X 0A9, Canada; Faculty of Nursing of the Université de Montréal, 2375 Chemin de la Côte-Sainte-Catherine, Montreal, Quebec H3T 1A8, Canada. Electronic address: jose.cote@umontreal.ca.""}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Beaudet', 'Affiliation': ""Research Centre of the Centre Hospitalier de l'Université de Montréal, 850 rue St-Denis, Montreal, Quebec H2X 0A9, Canada; Faculty of Nursing of the Université de Montréal, 2375 Chemin de la Côte-Sainte-Catherine, Montreal, Quebec H3T 1A8, Canada; Centre Hospitalier de l'Université de Montréal, 900 rue St-Denis, Montreal, Quebec H2X 0A9, Canada. Electronic address: line.beaudet.chum@ssss.gouv.qc.ca.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Auger', 'Affiliation': ""Research Chair in Innovative Nursing Practices, 850 rue St-Denis, Montreal, Quebec H2X 0A9, Canada; Research Centre of the Centre Hospitalier de l'Université de Montréal, 850 rue St-Denis, Montreal, Quebec H2X 0A9, Canada. Electronic address: patricia.auger.chum@ssss.gouv.qc.ca.""}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': 'Rouleau', 'Affiliation': ""Research Chair in Innovative Nursing Practices, 850 rue St-Denis, Montreal, Quebec H2X 0A9, Canada; Research Centre of the Centre Hospitalier de l'Université de Montréal, 850 rue St-Denis, Montreal, Quebec H2X 0A9, Canada. Electronic address: genevieve.rouleau.chum@ssss.gouv.qc.ca.""}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Chicoine', 'Affiliation': 'Research Chair in Innovative Nursing Practices, 850 rue St-Denis, Montreal, Quebec H2X 0A9, Canada; Faculty of Nursing of the Université de Montréal, 2375 Chemin de la Côte-Sainte-Catherine, Montreal, Quebec H3T 1A8, Canada. Electronic address: gabrielle.chicoine@umontreal.ca.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Léger', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, 900 rue St-Denis, Montreal, Quebec H2X 0A9, Canada. Electronic address: vanessa.leger.chum@ssss.gouv.qc.ca.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Keezer', 'Affiliation': ""Research Centre of the Centre Hospitalier de l'Université de Montréal, 850 rue St-Denis, Montreal, Quebec H2X 0A9, Canada; Centre Hospitalier de l'Université de Montréal, 900 rue St-Denis, Montreal, Quebec H2X 0A9, Canada; Faculty of Medicine of the Université de Montréal, 2900 Edouard Montpetit Blvd, Montreal, Quebec H3T 1J4, Canada. Electronic address: mark.keezer.chum@ssss.gouv.qc.ca.""}, {'ForeName': 'Marc-André', 'Initials': 'MA', 'LastName': 'Reid', 'Affiliation': 'Research Chair in Innovative Nursing Practices, 850 rue St-Denis, Montreal, Quebec H2X 0A9, Canada; Faculty of Nursing of the Université de Montréal, 2375 Chemin de la Côte-Sainte-Catherine, Montreal, Quebec H3T 1A8, Canada. Electronic address: marc-andre.reid@umontreal.ca.'}, {'ForeName': 'Dang Khoa', 'Initials': 'DK', 'LastName': 'Nguyen', 'Affiliation': ""Research Centre of the Centre Hospitalier de l'Université de Montréal, 850 rue St-Denis, Montreal, Quebec H2X 0A9, Canada; Centre Hospitalier de l'Université de Montréal, 900 rue St-Denis, Montreal, Quebec H2X 0A9, Canada; Faculty of Medicine of the Université de Montréal, 2900 Edouard Montpetit Blvd, Montreal, Quebec H3T 1J4, Canada. Electronic address: d.nguyen@umontreal.ca.""}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107581'] 3023,33248391,The HEALing (Helping to End Addiction Long-term SM ) Communities Study: Protocol for a cluster randomized trial at the community level to reduce opioid overdose deaths through implementation of an integrated set of evidence-based practices.,"BACKGROUND Opioid overdose deaths remain high in the U.S. Despite having effective interventions to prevent overdose deaths, there are numerous barriers that impede their adoption. The primary aim of the HEALing Communities Study (HCS) is to determine the impact of an intervention consisting of community-engaged, data-driven selection, and implementation of an integrated set of evidence-based practices (EBPs) on reducing opioid overdose deaths. METHODS The HCS is a four year multi-site, parallel-group, cluster randomized wait-list controlled trial. Communities (n = 67) in Kentucky, Massachusetts, New York and Ohio are randomized to active intervention (Wave 1), which starts the intervention in Year 1 or the wait-list control (Wave 2), which starts the intervention in Year 3. The HCS will test a conceptually driven framework to assist communities in selecting and adopting EBPs with three components: 1) a community engagement strategy with local coalitions to guide and implement the intervention; 2) a compendium of EBPs coupled with technical assistance; and 3) a series of communication campaigns to increase awareness and demand for EBPs and reduce stigma. An implementation science framework guides the intervention and allows for examination of the multilevel contexts that promote or impede adoption and expansion of EBPs. The primary outcome, number of opioid overdose deaths, will be compared between Wave 1 and Wave 2 communities during Year 2 of the intervention for Wave 1. Numerous secondary outcomes will be examined. DISCUSSION The HCS is the largest community-based implementation study in the field of addiction with an ambitious goal of significantly reducing fatal opioid overdoses.",2020,"The primary outcome, number of opioid overdose deaths, will be compared between Wave 1 and Wave 2 communities during Year 2 of the intervention for Wave 1.","['Communities (n\u202f=\u202f67) in Kentucky, Massachusetts, New York and Ohio']","['HEALing Communities Study (HCS', 'Long-term SM ']","['HEALing (Helping to End Addiction', 'number of opioid overdose deaths, will be compared between Wave 1 and Wave 2 communities']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0022557', 'cui_str': 'Kentucky'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0009462', 'cui_str': 'Community'}]",,0.104712,"The primary outcome, number of opioid overdose deaths, will be compared between Wave 1 and Wave 2 communities during Year 2 of the intervention for Wave 1.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108335'] 3024,33250383,"Multi-session electrical neuromodulation effects on craving, relapse and cognitive functions in cocaine use disorder: A randomized, sham-controlled tDCS study.","BACKGROUND The use of transcranial Direct Current Stimulation (tDCS) has previously shown promising results for reducing craving in cocaine use disorder. In this study we further explored the potential of tDCS as add-on intervention in the treatment of cocaine use disorder. METHODS In a randomized, placebo-controlled, between subject study, we applied tDCS bilaterally with the anodal electrode targeting the right dorsolateral prefrontal cortex (DLPFC; https://clinicaltrials.gov/ct2/show/NCT03025321). Patients with cocaine use disorder were allocated to ten sessions of either active tDCS (n = 29) or sham (n = 30) on five consecutive days. Inhibitory control and risky decision-making were measured via a Go-NoGo task and a two-choice gambling task, respectively, each at baseline, one day after all tDCS sessions and after three months. Relapse at follow-up and craving were also assessed. RESULTS There was no significant effect of active tDCS on the number of cocaine use days and craving. Relapse was frequent among patients who had received either active or sham tDCS (48.0 % and 69.2 %, respectively), despite an overall decrease in craving during the first two weeks of treatment. No effects were found on cognitive functions. An exploratory analysis for crack cocaine use only revealed that relapse rates were significantly reduced after active tDCS (n = 17) as compared to sham (n = 19). CONCLUSIONS No beneficial effects of tDCS on number of cocaine use days, craving and cognitive functions were found in the present study, but somewhat promising results were obtained regarding relapse rates among crack-cocaine users specifically. Further research is required to determine the efficacy of tDCS as a complementary treatment in cocaine use disorder.",2020,"No beneficial effects of tDCS on number of cocaine use days, craving and cognitive functions were found in the present study, but somewhat promising results were obtained regarding relapse rates among crack-cocaine users specifically.","['cocaine use disorder', 'Patients with cocaine use disorder']","['placebo', 'active or sham tDCS', 'active tDCS', 'tDCS', 'transcranial Direct Current Stimulation (tDCS']","['cognitive functions', 'craving, relapse and cognitive functions', 'craving', 'relapse rates', 'number of cocaine use days and craving', 'number of cocaine use days, craving and cognitive functions', 'Relapse']","[{'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.0346528,"No beneficial effects of tDCS on number of cocaine use days, craving and cognitive functions were found in the present study, but somewhat promising results were obtained regarding relapse rates among crack-cocaine users specifically.","[{'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Verveer', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, the Netherlands. Electronic address: verveer@essb.eur.nl.'}, {'ForeName': 'Frederik M', 'Initials': 'FM', 'LastName': 'van der Veen', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, the Netherlands.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Shahbabaie', 'Affiliation': 'Cognitive Psychology Unit, Institute of Psychology, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Remmerswaal', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, the Netherlands.'}, {'ForeName': 'Ingmar H A', 'Initials': 'IHA', 'LastName': 'Franken', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, the Netherlands.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108429'] 3025,33258997,A hypoenergetic diet with decreased protein intake does not reduce lean body mass in trained females.,"PURPOSE Increasing protein intake during energy restriction (ER) attenuates lean body mass (LBM) loss in trained males. However, whether this relationship exists in trained females is unknown. This study examined the impact of higher compared to lower protein intakes (35% versus 15% of energy intake) on body composition in trained females during 2 weeks of severe ER. METHODS Eighteen well-trained females completed a 1-week energy balanced diet (HD100), followed by a 2-week hypoenergetic (40% ER) diet (HD60). During HD60, participants consumed either a high protein (HP; 35% protein, 15% fat) or lower protein (CON; 15% protein, 35% fat) diet. Body composition, peak power, leg strength, sprint time, and anaerobic endurance were assessed at baseline, pre-HD60, and post-HD60. RESULTS Absolute protein intake was reduced during HD60 in the CON group (from 1.6 to 0.9 g·d·kgBM -1 ) and maintained in the HP group (~ 1.7 g·d·kgBM -1 ). CON and HP groups decreased body mass equally during HD60 (- 1.0 ± 1.1 kg; p = 0.026 and - 1.1 ± 0.7 kg; p = 0.002, respectively) and maintained LBM. There were no interactions between time point and dietary condition on exercise performance. CONCLUSION The preservation of LBM during HD60, irrespective of whether absolute protein intake is maintained or reduced, contrasts with findings in trained males. In trained females, the relationship between absolute protein intake and LBM change during ER warrants further investigation. Future recommendations for protein intake during ER should be expressed relative to body mass, not total energy intake, in trained females.",2021,"RESULTS Absolute protein intake was reduced during HD60 in the CON group (from 1.6 to 0.9 g·d·kgBM -1 ) and maintained in the HP group (~ 1.7 g·d·kgBM -1 ).","['trained females during 2\xa0weeks of severe ER', 'Eighteen well-trained females completed a', 'trained males', 'trained females']","['CON and HP', 'energy restriction (ER', 'hypoenergetic diet with decreased protein intake', '1-week energy balanced diet (HD100), followed by a 2-week hypoenergetic (40% ER) diet (HD60']","['body composition', 'protein intakes', 'Body composition, peak power, leg strength, sprint time, and anaerobic endurance', 'exercise performance', 'lean body mass', 'Absolute protein intake']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0452410', 'cui_str': 'Balanced diet'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}]",,0.0266973,"RESULTS Absolute protein intake was reduced during HD60 in the CON group (from 1.6 to 0.9 g·d·kgBM -1 ) and maintained in the HP group (~ 1.7 g·d·kgBM -1 ).","[{'ForeName': 'Alice G', 'Initials': 'AG', 'LastName': 'Pearson', 'Affiliation': 'Department of Sport and Exercise Sciences, Durham University, Durham, UK.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Alexander', 'Affiliation': 'Physiology, Exercise and Nutrition Research Group, University of Stirling, Stirling, UK.'}, {'ForeName': 'Oliver C', 'Initials': 'OC', 'LastName': 'Witard', 'Affiliation': ""Centre of Human and Applied Physiological Research, King's College London, London, UK.""}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Coughlin', 'Affiliation': 'Physiology, Exercise and Nutrition Research Group, University of Stirling, Stirling, UK.'}, {'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Tipton', 'Affiliation': 'Department of Sport and Exercise Sciences, Durham University, Durham, UK.'}, {'ForeName': 'Ian H', 'Initials': 'IH', 'LastName': 'Walshe', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle, UK. ian2.walshe@northumbria.ac.uk.'}]",European journal of applied physiology,['10.1007/s00421-020-04555-7'] 3026,33822798,"The effect of Moringa oleifera capsule in increasing breastmilk volume in early postpartum patients: A double-blind, randomized controlled trial.","Moringa oleifera is an herbal galactagogue that has been used to increase the volume of breastmilk. Few studies have evaluated the effect of Moringa oleifera in breastfeeding. There are conflicting data whether it can increase the volume of breastmilk or not. Thus, the objective of this study is to evaluate the efficacy of Moringa oleifera leaves in increasing the volume of breastmilk in early postpartum mothers. A randomized, double-blind, placebo-controlled trial will be conducted. The outcomes of this study will provide the data of Moringa oleifera as an herbal medication to increase the volume of breastmilk. This information will be used to increase the rate of exclusive breastfeeding for the first 6 months as recommended by the World Health Organization. Clinical trial registration This clinical trial was registered at ClinicalTrials.gov (Clinical trials registration: NCT04487613).",2021,Moringa oleifera is an herbal galactagogue that has been used to increase the volume of breastmilk.,"['early postpartum mothers', 'early postpartum patients']","['placebo', 'Moringa oleifera capsule']",['rate of exclusive breastfeeding'],"[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0949952', 'cui_str': 'Drumsticktree'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}]",,0.430292,Moringa oleifera is an herbal galactagogue that has been used to increase the volume of breastmilk.,"[{'ForeName': 'Siraphat', 'Initials': 'S', 'LastName': 'Fungtammasan', 'Affiliation': 'Placental Related Diseases Research Unit, Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Vorapong', 'Initials': 'V', 'LastName': 'Phupong', 'Affiliation': 'Placental Related Diseases Research Unit, Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}]",PloS one,['10.1371/journal.pone.0248950'] 3027,33825795,"""BRUSH UP"": AN INNOVATIVE TECHNOLOGICAL AID FOR PARENTS TO KEEP A CHECK OF THEIR CHILDREN'S ORAL HYGIENE BEHAVIOUR.","OBJECTIVE To investigate the impact of ""Brush Up"" - a mobile application, on oral hygiene behaviours of 4-6-year-old children in Bangalore city. METHODS In this experimental study, 247 children aged 4-6, were randomly divided into three groups. Considering ""Brush Up"" is a mobile application, parents of the children in Group 1 (n=82) downloaded the application on their smartphones. Children in Group 2 (n=83) and Group 3 (n=82) received tooth brushing instructions by an educative video and manual demonstration, respectively. Effectiveness of tooth brushing was assessed with plaque scores, which were recorded for all the groups at baseline and one month using Visible Biofilm Index. RESULTS Wilcoxon signed rank test showed a significant improvement in the tooth brushing behaviour for the Brush Up group, which was indicated by a lower plaque score after a follow-up of one month. Kruskal-Wallis test followed by post-hoc test showed that the mean ranks of plaque scores of Brush Up group are consistently lower than those of video demonstration group and manual demonstration group. CONCLUSIONS The lower plaque score in subsequent follow-up in Brush Up group suggests that using a smart system can enhance learning a correct tooth brushing method in young children and can also help in implementing the required reinforcement and motivation to brush and aid in better plaque control.",2021,"Wilcoxon signed rank test showed a significant improvement in the tooth brushing behaviour for the Brush Up group, which was indicated by a lower plaque score after a follow-up of one month.","['247 children aged 4-6', '4-6-year-old children in Bangalore city']",[],"['tooth brushing behaviour', 'mean ranks of plaque scores', 'plaque score', 'lower plaque score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]",[],"[{'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",247.0,0.0295248,"Wilcoxon signed rank test showed a significant improvement in the tooth brushing behaviour for the Brush Up group, which was indicated by a lower plaque score after a follow-up of one month.","[{'ForeName': 'Ruttika Vijay', 'Initials': 'RV', 'LastName': 'Desai', 'Affiliation': 'Dr. D.Y. Patil Vidyapeeth, Pune, Maharashtra, India.'}, {'ForeName': 'Nivedita Chandrashekhar', 'Initials': 'NC', 'LastName': 'Badrapur', 'Affiliation': 'P.M.N.M. Dental College and Hospital, Bagalkot, India.'}, {'ForeName': 'Harshitha', 'Initials': 'H', 'LastName': 'Mittapalli', 'Affiliation': ""K.L.E Society's Institute of Dental Sciences, Bangalore, India.""}, {'ForeName': 'Bagepalli Keshavappa', 'Initials': 'BK', 'LastName': 'Srivastava', 'Affiliation': ""K.L.E Society's Institute of Dental Sciences, Bangalore, India.""}, {'ForeName': 'Shruthi', 'Initials': 'S', 'LastName': 'Eshwar', 'Affiliation': ""K.L.E Society's Institute of Dental Sciences, Bangalore, India.""}, {'ForeName': 'Vipin', 'Initials': 'V', 'LastName': 'Jain', 'Affiliation': ""K.L.E Society's Institute of Dental Sciences, Bangalore, India.""}]",Revista paulista de pediatria : orgao oficial da Sociedade de Pediatria de Sao Paulo,['10.1590/1984-0462/2021/39/2020085'] 3028,33825761,Dentinal tubule occlusion using Er:YAG Laser: an in vitro study.,"OBJECTIVES We analyzed the effects of the Er:YAG laser used with different parameters on dentinal tubule (DT) occlusion, intrapulpal temperature and pulp tissue morphology in order to determine the optimal parameters for treating dentin hypersensitivity. METHODOLOGY Dentin specimens prepared from 36 extracted human third molars were randomized into six groups according to the treatment method (n=6 each): control (A); Gluma desensitizer (B); and Er:YAG laser treatment at 0.5 W , 167 J/cm2 (50 mJ, 10 Hz) (C), 1 W , 334 J/cm2 (50 mJ, 20 Hz) (D), 2 W , 668 J/cm2 (100 mJ, 20 Hz) (E), and 4 W and 1336 J/cm2 (200 mJ, 20 Hz) (F). Treatment-induced morphological changes of the dentin surfaces were assessed using scanning electron microscopy (SEM) to find parameters showing optimal dentin tubule occluding efficacy. To further verify the safety of these parameters (0.5 W, 167 J/cm2), intrapulpal temperature changes were recorded during laser irradiation, and morphological alterations of the dental pulp tissue were observed with an upright microscope. RESULTS Er:YAG laser irradiation at 0.5 W (167 J/cm2) were found to be superior in DT occlusion, with an exposure rate significantly lower than those in the other groups (P<0.05). Intrapulpal temperature changes induced by Er:YAG laser irradiation at 0.5 W (167 J/cm2) with (G) and without (H) water and air cooling were demonstrated to be below the threshold. Also, no significant morphological alterations of the pulp and odontoblasts were observed after irradiation. CONCLUSION Therefore, 0.5 W (167 J/cm2) is a suitable parameter for Er:YAG laser to occlude DTs, and it is safe to the pulp tissue.",2021,Intrapulpal temperature changes induced by Er:YAG laser irradiation at 0.5 W (167 J/cm2) with (G) and without (H) water and air cooling were demonstrated to be below the threshold.,['Dentin specimens prepared from 36 extracted human third molars'],"['Er:YAG laser irradiation', 'control (A); Gluma desensitizer (B); and Er:YAG laser treatment', 'Dentinal tubule occlusion using Er:YAG Laser', 'Er:YAG laser']","['dentinal tubule (DT) occlusion, intrapulpal temperature and pulp tissue morphology']","[{'cui': 'C1292488', 'cui_str': 'Dentin specimen'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}]","[{'cui': 'C0457903', 'cui_str': 'Erbium:YAG laser device'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0673224', 'cui_str': 'gluma desensitizer'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0227017', 'cui_str': 'Dentinal tubules'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}]","[{'cui': 'C0227017', 'cui_str': 'Dentinal tubules'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}]",,0.0125018,Intrapulpal temperature changes induced by Er:YAG laser irradiation at 0.5 W (167 J/cm2) with (G) and without (H) water and air cooling were demonstrated to be below the threshold.,"[{'ForeName': 'Hongmin', 'Initials': 'H', 'LastName': 'Zhuang', 'Affiliation': 'Southern Medical University, Nanfang Hospital, Department of Stomatology, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yuee', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Southern Medical University, Nanfang Hospital, Department of Stomatology, Guangzhou, Guangdong, China.'}, {'ForeName': 'Shaowen', 'Initials': 'S', 'LastName': 'Xiang', 'Affiliation': 'Southern Medical University, Stomatological Hospital, Guangzhou, Guangdong, China.'}, {'ForeName': 'Huanying', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Southern Medical University, Nanfang Hospital, Department of Stomatology, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xingzhu', 'Initials': 'X', 'LastName': 'Dai', 'Affiliation': 'Southern Medical University, Nanfang Hospital, Department of Stomatology, Guangzhou, Guangdong, China.'}, {'ForeName': 'Wanghong', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Southern Medical University, Nanfang Hospital, Department of Stomatology, Guangzhou, Guangdong, China.'}]",Journal of applied oral science : revista FOB,['10.1590/1678-7757-2020-0266'] 3029,33825753,Association of Nd:YAG laser and calcium-phosphate desensitizing pastes on dentin permeability and tubule occlusion.,"OBJECTIVE To evaluate the efficacy of Nd:YAG laser associated with calcium-phosphate desensitizing pastes on dentin permeability and tubule occlusion after erosive/abrasive challenges. METHODOLOGY Dentin specimens were exposed to 17% ethylene diamine tetra-acetic acid (EDTA) solution for 5 min and randomly allocated into five groups: G1, control (no treatment); G2, Nd:YAG laser (1 W, 10 Hz, 100 mJ, 85 J/cm2); G3, Laser + TeethmateTM Desensitizer; G4, Laser + Desensibilize Nano P; and G5, Laser+Nupro®. Specimens underwent a 5-day erosion-abrasion cycling. Hydraulic conductance was measured post-EDTA, post-treatment, and post-cycling. Post-treatment and post-cycling permeability (%Lp) was calculated based on post-EDTA measurements, considered 100%. Open dentin tubules (ODT) were calculated at the abovementioned experimental moments using scanning electron microscopy and ImageJ software (n=10). Data were analyzed using two-way repeated measures ANOVA and Tukey's test (α=0.05). RESULTS G1 presented the highest %Lp post-treatment of all groups (p<0.05), without significantly differences among them. At post-cycling, %Lp significantly decreased in G1, showed no significant differences from post-treatment in G3 and G4, and increased in G2 and G5, without significant differences from G1 (p>0.05). We found no significant differences in ODT among groups (p>0.05) post-EDTA. At post-treatment, treated groups did not differ from each other, but presented lower ODT than G1 (p<0.001). As for post-cycling, we verified no differences among groups (p>0.05), although ODT was significantly lower for all groups when compared to post-EDTA values (p<0.001). CONCLUSION All treatments effectively reduced dentin permeability and promoted tubule occlusion after application. COMBINING ND YAG laser with calcium-phosphate pastes did not improve the laser effect. After erosive-abrasive challenges, treatments presented no differences when compared to the control.",2021,"RESULTS G1 presented the highest %Lp post-treatment of all groups (p<0.05), without significantly differences among them.",['Dentin specimens were exposed to 17'],"['Laser + TeethmateTM Desensitizer; G4, Laser + Desensibilize Nano P; and G5, Laser+Nupro®', 'Nd:YAG laser', 'ethylene diamine tetra-acetic acid (EDTA) solution', '5-day erosion-abrasion cycling', 'G1, control (no treatment); G2, Nd:YAG laser']","['dentin permeability', 'dentin permeability and tubule occlusion', 'laser effect', 'ODT', 'Hydraulic conductance', 'Open dentin tubules (ODT']","[{'cui': 'C1292488', 'cui_str': 'Dentin specimen'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0392276', 'cui_str': 'Neodymium-YAG laser'}, {'cui': 'C0015091', 'cui_str': 'Ethylenediamine'}, {'cui': 'C1010292', 'cui_str': 'Tetragonopterus'}, {'cui': 'C0000983', 'cui_str': 'Acetic Acid'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0518443', 'cui_str': 'Abrasion and/or friction burn of skin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0011431', 'cui_str': 'Dentin Permeability'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}]",,0.025304,"RESULTS G1 presented the highest %Lp post-treatment of all groups (p<0.05), without significantly differences among them.","[{'ForeName': 'Vinícius', 'Initials': 'V', 'LastName': 'Maximiano', 'Affiliation': 'Universidade de São Paulo, Faculdade de Odontologia, Departamento de Dentística, São Paulo, SP, Brasil.'}, {'ForeName': 'Alana Cristina', 'Initials': 'AC', 'LastName': 'Machado', 'Affiliation': 'Universidade de São Paulo, Faculdade de Odontologia, Departamento de Dentística, São Paulo, SP, Brasil.'}, {'ForeName': 'Raquel Marianna', 'Initials': 'RM', 'LastName': 'Lopes', 'Affiliation': 'Universidade de São Paulo, Faculdade de Odontologia, Departamento de Dentística, São Paulo, SP, Brasil.'}, {'ForeName': 'Fernanda Ellen Mercatelli', 'Initials': 'FEM', 'LastName': 'Rabelo', 'Affiliation': 'Universidade de São Paulo, Faculdade de Odontologia, Departamento de Dentística, São Paulo, SP, Brasil.'}, {'ForeName': 'Stephanie Assimakopoulos', 'Initials': 'SA', 'LastName': 'Garófalo', 'Affiliation': 'Universidade de São Paulo, Faculdade de Odontologia, Departamento de Dentística, São Paulo, SP, Brasil.'}, {'ForeName': 'Denise Maria', 'Initials': 'DM', 'LastName': 'Zezell', 'Affiliation': 'Universidade de São Paulo, Instituto de Pesquisas Energéticas e Nucleares (IPEN/CNEM), São Paulo, SP, Brasil.'}, {'ForeName': 'Ana Cecilia Corrêa', 'Initials': 'ACC', 'LastName': 'Aranha', 'Affiliation': ''}, {'ForeName': 'Taís', 'Initials': 'T', 'LastName': 'Scaramucci', 'Affiliation': ''}]",Journal of applied oral science : revista FOB,['10.1590/1678-7757-2020-0736'] 3030,33828909,Differences between adjusted vs. non-adjusted loads in velocity-based training: consequences for strength training control and programming.,"Strength and conditioning specialists commonly deal with the quantification and selection the setting of protocols regarding resistance training intensities. Although the one repetition maximum (1RM) method has been widely used to prescribe exercise intensity, the velocity-based training (VBT) method may enable a more optimal tool for better monitoring and planning of resistance training (RT) programs. The aim of this study was to compare the effects of two RT programs only differing in the training load prescription strategy (adjusting or not daily via VBT) with loads from 50 to 80% 1RM on 1RM, countermovement (CMJ) and sprint. Twenty-four male students with previous experience in RT were randomly assigned to two groups: adjusted loads (AL) ( n  = 13) and non-adjusted loads (NAL) ( n  = 11) and carried out an 8-week (16 sessions) RT program. The performance assessment pre- and post-training program included estimated 1RM and full load-velocity profile in the squat exercise; countermovement jump (CMJ); and 20-m sprint (T20). Relative intensity (RI) and mean propulsive velocity attained during each training session (V session ) was monitored. Subjects in the NAL group trained at a significantly faster V session than those in AL ( p < 0.001) (0.88-0.91 vs. 0.67-0.68 m/s, with a ∼15% RM gap between groups for the last sessions), and did not achieve the maximum programmed intensity (80% RM). Significant differences were detected in sessions 3-4, showing differences between programmed and performed V session and lower RI and velocity loss (VL) for the NAL compared to the AL group ( p < 0.05). Although both groups improved 1RM, CMJ and T20, NAL experienced greater and significant changes than AL (28.90 vs.12.70%, 16.10 vs. 7.90% and -1.99 vs. -0.95%, respectively). Load adjustment based on movement velocity is a useful way to control for highly individualised responses to training and improve the implementation of RT programs.",2021,"Subjects in the NAL group trained at a significantly faster V session than those in AL ( p < 0.001) (0.88-0.91 vs. 0.67-0.68 m/s, with a ∼15% RM gap between groups for the last sessions), and did not achieve the maximum programmed intensity (80% RM).",['Twenty-four male students with previous experience in RT'],['squat exercise; countermovement jump (CMJ); and 20-m sprint (T20'],"['Relative intensity (RI) and mean propulsive velocity', '1RM, CMJ and T20, NAL', '1RM, countermovement (CMJ) and sprint', 'RI and velocity loss (VL']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3653283', 'cui_str': 'PROPULSIVES'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}]",24.0,0.00362525,"Subjects in the NAL group trained at a significantly faster V session than those in AL ( p < 0.001) (0.88-0.91 vs. 0.67-0.68 m/s, with a ∼15% RM gap between groups for the last sessions), and did not achieve the maximum programmed intensity (80% RM).","[{'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Jiménez-Reyes', 'Affiliation': 'Centre for Sport Studies, Rey Juan Carlos University, Madrid, Spain.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Castaño-Zambudio', 'Affiliation': 'Centre for Sport Studies, Rey Juan Carlos University, Madrid, Spain.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Cuadrado-Peñafiel', 'Affiliation': 'Department of Physical Education, Sport and Human Motricity, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Jorge M', 'Initials': 'JM', 'LastName': 'González-Hernández', 'Affiliation': 'Faculty of Health Sciences, Universidad Europea de Canarias, La Orotava, Tenerife, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Capelo-Ramírez', 'Affiliation': 'Faculty of Education Sciences, SPORT Research Group (CTS-1024), CERNEP, University of Almeria, Almeria, Spain.'}, {'ForeName': 'Luis M', 'Initials': 'LM', 'LastName': 'Martínez-Aranda', 'Affiliation': 'Faculty of Sport.Neuromove Research Group, Catholic University of San Antonio, Murcia, Spain.'}, {'ForeName': 'Juan J', 'Initials': 'JJ', 'LastName': 'González-Badillo', 'Affiliation': 'Physical Performance & Athletic Research Center, Faculty of Sports Science, Pablo de Olavide University, Sevilla, Spain.'}]",PeerJ,['10.7717/peerj.10942'] 3031,33828875,Effect of Low-Level Laser Therapy on Peri-Miniscrew Fluid Prostaglandin E2 and Substance P Levels: A Controlled Clinical Trial.,"Objective This study aims to evaluate the effect of low-level laser therapy on peri-miniscrew fluid prostaglandin E2 (PGE2) and substance P (SP) levels during orthodontic treatment. Methods A total of 15 individuals were included in this study. Miniscrews were inserted to the inter-radicular region of the maxillary right and left second premolar and the first molar teeth, and diode lasers were randomly applied to the right or left side. Irradiation was performed at 940 nm wavelength using a gallium-aluminum-arsenide diode laser with 100 mW power output, 0.125 cm2 spectral area, 8 J/cm2 energy density, and 10 seconds of exposure time. Peri-miniscrew fluid samples were collected on the 1st, 3rd, and 7th days, and PGE2 and SP levels were assessed. For statistical comparison, two-way (factors) analysis of variance with repeated measurements on one-factor levels was used at statistical significance (p) of <0.05. Results PGE2 levels on the 1st, 3rd, and 7th days were 160.64±10.05, 135.17±37.18, and 98.57±22.94, respectively, in the control group and 150.75±9.08, 87.17±40.67, and 78.10±16.50, respectively, in the laser group. SP levels on the 1st, 3rd, and 7th days were 79.90±12.05, 64.61±10.05, and 70.05±9.10, respectively, in the control group and 76.32±11.39, 60.25±9.08, and 65.71±5.59, respectively, in the laser group. The differences in PGE2 and SP levels between the laser and control groups were not statistically significant at all time intervals. Conclusion Low-level laser therapy cannot be recommended as a clinical adjunct therapy to reduce inflammation and pain around the miniscrews.",2021,"The differences in PGE2 and SP levels between the laser and control groups were not statistically significant at all time intervals. ",['Methods\n\n\nA total of 15 individuals'],"['Low-Level Laser Therapy', 'Low-level laser therapy', 'low-level laser therapy']","['PGE2 levels', 'Peri-Miniscrew Fluid Prostaglandin E2 and Substance P Levels', 'SP levels', 'PGE2 and SP levels', 'peri-miniscrew fluid prostaglandin E2 (PGE2) and substance P (SP) levels']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}]","[{'cui': 'C0012472', 'cui_str': 'Dinoprostone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0038585', 'cui_str': 'Substance P'}]",15.0,0.0775444,"The differences in PGE2 and SP levels between the laser and control groups were not statistically significant at all time intervals. ","[{'ForeName': 'Özer', 'Initials': 'Ö', 'LastName': 'Alkan', 'Affiliation': 'Department of Orthodontics, Ankara Yıldırım Beyazıt University Faculty of Dentistry, Ankara, Turkey.'}, {'ForeName': 'Yeşim', 'Initials': 'Y', 'LastName': 'Kaya', 'Affiliation': 'Department of Orthodontics, Yuzuncu Yıl University Faculty of Dentistry, Van, Turkey.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Yüksek', 'Affiliation': 'Department of Orthodontics, Yuzuncu Yıl University Faculty of Dentistry, Van, Turkey.'}, {'ForeName': 'Ahmet Ufuk', 'Initials': 'AU', 'LastName': 'Kömüroglu', 'Affiliation': 'Health Service Vocational School of Higher Education, Van, Turkey.'}]",Turkish journal of orthodontics,['10.5152/TurkJOrthod.2021.20049'] 3032,33828845,EMBRACE intervention to improve the continuum of care in maternal and newborn health in Ghana: The RE-AIM framework-based evaluation.,"Background Improving maternal and newborn health remains one of the most critical public health challenges, particularly in low- and lower-middle-income countries. To overcome this challenge, interventions to improve the continuum of care based on real-world settings need to be provided. The Ghana Ensure Mothers and Babies Regular Access to Care (EMBRACE) Implementation Research Team conducted a unique intervention program involving over 21 000 women to improve the continuum of care, thereby demonstrating an intervention program's effectiveness in a real-world setting. This study evaluates the implementation process of the EMBRACE intervention program based on the RE-AIM framework. Methods A cluster-randomized controlled trial was conducted in 32 sub-district-based clusters in Ghana. Interventions comprised of four components, and to evaluate the implementation process, we conducted baseline and endline questionnaire surveys for women who gave birth and lived in the study site. The key informant interviews of health workers and intervention monitoring were conducted at the health facilities in the intervention area. The data were analyzed using 34 components of the RE-AIM framework and classified under five general criteria (Reach, Effectiveness, Adoption, Implementation, and Maintenance). Results In total, 1480 and 1490 women participated in the baseline and endline questionnaire survey, respectively. In the intervention area, 83.8% of women participated (reach). The completion rate of the continuum of care increased from 7.5% to 47.1%. Newborns who had danger signs immediately after birth decreased after the intervention (relative risk = 0.82, 95% confidence interval = 0.68-0.99) (effectiveness). In the intervention area, 94% of all health facilities participated. Mothers willing to use their continuum of care cards in future pregnancies reached 87% (adoption). Supervision and manual use resolved the logistical and human resource challenges identified initially (implementation). The government included the continuum of care measures in their routine program and developed a new Maternal and Child Health Record Book, which was successfully disseminated nationwide (maintenance). Conclusions Following the RE-AIM framework evaluation, the EMBRACE intervention program was considered effective and as having great potential for scaling across in real-world settings, especially where the continuum of care needs to be improved. Trial registration ISRCTN 90618993.",2021,"Newborns who had danger signs immediately after birth decreased after the intervention (relative risk = 0.82, 95% confidence interval = 0.68-0.99) (effectiveness).","['In total, 1480 and 1490 women participated in the baseline and endline questionnaire survey, respectively', '32 sub-district-based clusters in Ghana', 'women who gave birth and lived in the study site', 'maternal and newborn health in Ghana']",['Care (EMBRACE'],['completion rate of the continuum of care'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0017516', 'cui_str': 'Ghana'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C4042838', 'cui_str': 'Neonatal Health'}]",[],"[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009853', 'cui_str': 'Continuity of Care'}]",,0.0353839,"Newborns who had danger signs immediately after birth decreased after the intervention (relative risk = 0.82, 95% confidence interval = 0.68-0.99) (effectiveness).","[{'ForeName': 'Kimiyo', 'Initials': 'K', 'LastName': 'Kikuchi', 'Affiliation': 'Department of Community and Global Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Gyapong', 'Affiliation': 'Institute for Health Research, University of Health and Allied Sciences, Volta, Ghana.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Shibanuma', 'Affiliation': 'Department of Community and Global Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Asah', 'Affiliation': 'Institute for Health Research, University of Health and Allied Sciences, Volta, Ghana.'}, {'ForeName': 'Sumiyo', 'Initials': 'S', 'LastName': 'Okawa', 'Affiliation': 'Department of Community and Global Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Addei', 'Affiliation': 'Dodowa Health Research Centre, Dodowa, Greater Accra, Ghana.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Nanishi', 'Affiliation': 'Office of International Academic Affairs, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Tawiah', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Brong-Ahafo, Ghana.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Yasuoka', 'Affiliation': 'Research and Education Center for Prevention of Global Infectious Diseases of Animals, Tokyo University of Agriculture and Technology, Tokyo, Japan.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Yeji', 'Affiliation': 'Navrongo Health Research Centre, Navrongo, Upper East, Ghana.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Oduro', 'Affiliation': 'Navrongo Health Research Centre, Navrongo, Upper East, Ghana.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Owusu-Agyei', 'Affiliation': 'Institute for Health Research, University of Health and Allied Sciences, Volta, Ghana.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Quansah-Asare', 'Affiliation': 'Ghana Health Service, Accra, Ghana.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Hodgson', 'Affiliation': 'Research and Development Division, Ghana Health Service, Accra, Ghana.'}, {'ForeName': 'Masamine', 'Initials': 'M', 'LastName': 'Jimba', 'Affiliation': 'Department of Community and Global Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of global health,['10.7189/jogh.11.04017'] 3033,33828808,Pupillary and Microsaccadic Responses to Cognitive Effort and Emotional Arousal During Complex Decision Making.,"A large body of literature documents the sensitivity of pupil response to cognitive load (1)and emotional arousal (2). Recent empirical evidence also showed that microsaccade characteristics and dynamics can be modulated by mental fatigue and cognitive load (3). Very little is known about the sensitivity of microsaccadic characteristics to emotional arousal. The present paper demonstrates in a controlled experiment pupillary and microsaccadic responses to information processing during multi-attribute decision making under affective priming. Twenty-one psychology students were randomly assigned into three affective priming conditions (neutral, aversive, and erotic). Participants were tasked to make several discriminative decisions based on acquired cues. In line with the expectations, results showed microsaccadic rate inhibition and pupillary dilation depending on cognitive effort (number of acquired cues) prior to decision. These effects were moderated by affective priming. Aversivepriming strengthened pupillary and microsaccadic response to information processing effort.In general, results suggest that pupillary response is more biased by affective priming than microsaccadic rate. The results are discussed in the light of neuropsychological mechanisms of pupillary and microsaccadic behavior generation.",2020,Aversivepriming strengthened pupillary and microsaccadic response to information processing effort.,['Twenty-one psychology students'],[],"['Pupillary and Microsaccadic Responses to Cognitive Effort and Emotional Arousal', 'microsaccadic rate inhibition and pupillary dilation']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",[],"[{'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0026961', 'cui_str': 'Dilated pupil'}]",21.0,0.0381592,Aversivepriming strengthened pupillary and microsaccadic response to information processing effort.,"[{'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Krejtz', 'Affiliation': 'Institute of Psychology, SWPS University of Social Sciences and Humanities, Warsaw, Poland.'}, {'ForeName': 'Justyna', 'Initials': 'J', 'LastName': 'Żurawska', 'Affiliation': 'Institute of Psychology, SWPS University of Social Sciences and Humanities, Warsaw, Poland.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Duchowski', 'Affiliation': 'School of Computing, Clemson University, Clemson, SC, USA.'}, {'ForeName': 'Szymon', 'Initials': 'S', 'LastName': 'Wichary', 'Affiliation': ''}]",Journal of eye movement research,['10.16910/jemr.13.5.2'] 3034,33828777,Effect of a visual tracking intervention on attention and behavior of children with Attention Deficit Hyperactivity Disorder.,"Attention deficit hyperactivity disorder is characterized by several cognitive and behavioral problems such as inattention and impulsivity, abnormal control of eye movements and relocation, visual fixation and visuospatial perception. There is a link between core motor functions such as oculomotor function and cognition to the extent that the oculomotor system acts as a mediator between the motor and cognitive functions. Therefore, the effects of eye-tracking intervention were investigated on attention in these children. Thirty - nine boys with ADHD, 6 to 10 years of age were recruited and randomized to receive current occupational therapy (control group), or occupational therapy accompanied with eye-tracking exercises (experimental group). They were evaluated using the Conner's Parent Rating Scale, the Continuous Performance Task-2, and the Test of Visual-Motor Skills-Revised before and after the intervention. Significant improvements in the mean scores of cognitive problems (F=9/22), coping behavior (F=6.03) and hyperactivity (F=9.77) were detected in the posttest between the two groups (p<0.05). Furthermore, in the Continuous Performance Test scores, detectability (F=5.68), omission errors (F=17.89), commission errors (F=19.45), reaction time (F=8.95), variability (F=7.07), and preservation (F=6.33) showed significant differences between control and experimental groups (p<0.01). It appears that eye-tracking interventions designed based on the isolation of neck and eye movement might have an important role in improving cognitive function and coping behaviors in these children. It seems that these exercises could increase eye movement control; improve cognitive function and response inhibition.",2020,"Significant improvements in the mean scores of cognitive problems (F=9/22), coping behavior (F=6.03) and hyperactivity (F=9.77) were detected in the posttest between the two groups (p<0.05).","['Thirty - nine boys with ADHD, 6 to 10 years of age', 'children with Attention Deficit Hyperactivity Disorder']","['eye-tracking intervention', 'visual tracking intervention', 'current occupational therapy (control group), or occupational therapy accompanied with eye-tracking exercises (experimental group']","['cognitive function and response inhibition', 'Continuous Performance Test scores, detectability (F=5.68), omission errors (F=17.89), commission errors (F=19.45), reaction time', 'mean scores of cognitive problems (F=9/22), coping behavior (F=6.03) and hyperactivity']","[{'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}]",39.0,0.00805967,"Significant improvements in the mean scores of cognitive problems (F=9/22), coping behavior (F=6.03) and hyperactivity (F=9.77) were detected in the posttest between the two groups (p<0.05).","[{'ForeName': 'Shiva', 'Initials': 'S', 'LastName': 'Janmohammadi', 'Affiliation': ''}, {'ForeName': 'Hojjat Allah', 'Initials': 'HA', 'LastName': 'Haghgoo', 'Affiliation': 'University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Farahbod', 'Affiliation': 'Exceptional Children Research Institute, Institute of Education, Organization for Education and Planning, Tehran, Iran.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Overton', 'Affiliation': 'Department of Psychology University of Sheffield, UK.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Pishyareh', 'Affiliation': 'University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}]",Journal of eye movement research,['10.16910/jemr.12.8.6'] 3035,33827012,Brief report: A randomized controlled trial of a compensatory cognitive training to improve prospective memory performance in people with schizophrenia or depression.,"People with schizophrenia or depression have prospective memory (PM) deficits, which affect their daily living. Given the paucity of research into training to correct PM deficits, we subjected a group of participants to a Chinese version of the PM module of the Cognitive Compensatory Training (CCT-C-PM) intervention to study its effect on their PM performance. Specifically, we independently randomized two diagnostic cohorts (schizophrenia and depression) into control groups (occupational therapy only) or experimental groups (CCT-C-PM and occupational therapy). The schizophrenia cohort had 17 participants in its control group and 23 participants in its experimental group. The depression cohort had 10 participants in its control group and 12 participants in its experimental group. The sociodemographic information of the participants was collected. Their symptoms and PM performances were measured at baseline and after treatment (after the completion of the CCT-C-PM intervention in the experimental group and the same timeframe in the control group). The treatment effects were examined by a repeated measure analysis of variance/analysis of covariance and a post hoc Scheffé test. The effect sizes (Cohen's d) of treatments against the controls were also calculated. There was no difference between the experimental and control groups in either cohort in terms of sociodemographic data, symptoms, and PM measures at baseline. The sex combination differed across the groups in the depression cohort. We found that the CCT-C-PM improved PM, especially event-based PM, for which large effect sizes were seen. The effect on time-based PM was unclear and requires future study. Our findings suggest that the CCT-C-PM is a viable training method for improving PM.",2021,"There was no difference between the experimental and control groups in either cohort in terms of sociodemographic data, symptoms, and PM measures at baseline.","['people with schizophrenia or depression', 'People with schizophrenia or depression', '17 participants in its control group and 23 participants in its experimental group']","['compensatory cognitive training', 'control groups (occupational therapy only) or experimental groups (CCT-C-PM and occupational therapy', 'Cognitive Compensatory Training (CCT-C-PM) intervention']","['sociodemographic data, symptoms, and PM measures', 'symptoms and PM performances']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4049005', 'cui_str': 'Cataract, total congenital with posterior sutural opacities in Heterozygotes'}, {'cui': 'C0589154', 'cui_str': 'Prospective memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0589154', 'cui_str': 'Prospective memory'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",2.0,0.024678,"There was no difference between the experimental and control groups in either cohort in terms of sociodemographic data, symptoms, and PM measures at baseline.","[{'ForeName': 'Raymond W C', 'Initials': 'RWC', 'LastName': 'Au', 'Affiliation': 'Occupational Therapy Department, United Christian Hospital, Hong Kong. Electronic address: awc460@ha.org.hk.'}, {'ForeName': 'Helen N W', 'Initials': 'HNW', 'LastName': 'Sezto', 'Affiliation': 'Occupational Therapy Department, United Christian Hospital, Hong Kong.'}, {'ForeName': 'Vera W M', 'Initials': 'VWM', 'LastName': 'Lam', 'Affiliation': 'Occupational Therapy Department, United Christian Hospital, Hong Kong.'}, {'ForeName': 'Y T', 'Initials': 'YT', 'LastName': 'Wan', 'Affiliation': 'Department of Psychiatry, United Christian Hospital, Hong Kong.'}, {'ForeName': 'L T', 'Initials': 'LT', 'LastName': 'Poon', 'Affiliation': 'Department of Psychiatry, United Christian Hospital, Hong Kong.'}, {'ForeName': 'P F', 'Initials': 'PF', 'LastName': 'Pang', 'Affiliation': 'Department of Psychiatry, United Christian Hospital, Hong Kong.'}, {'ForeName': 'Jackson K K', 'Initials': 'JKK', 'LastName': 'Wong', 'Affiliation': 'Occupational Therapy Department, United Christian Hospital, Hong Kong.'}]",Psychiatry research,['10.1016/j.psychres.2021.113914'] 3036,33826992,Written expressive disclosure in adults with irritable bowel syndrome: A randomized controlled trial.,"BACKGROUND The benefits of written expressive disclosure (WED) to health are documented in a variety of healthy and clinical populations. This study investigates the effect of WED on health-related outcomes in irritable bowel syndrome (IBS). METHODS Adults (N = 189) meeting Rome III criteria for IBS were randomly assigned to write about their: (1) deepest thoughts and feelings about the most stressful life event of the past five years (n = 67), (2) deepest thoughts and feelings about their IBS (n = 61) or (3) daily activities in an objective manner (control condition; n = 61). Participants completed four 20-min writing sessions over 2-6 weeks. Gastrointestinal (GI) symptoms, healthcare utilization, health-related quality of life (HR-QOL), pain catastrophizing, and pain self-efficacy were assessed at baseline, one month post-writing completion, and three months post-writing completion. RESULTS A significant group (combined WED vs. control) X time interaction was detected for healthcare utilization, F(1,147) = 6.16, p = 0.014, η 2  = 0.04. Specifically, number of GI-related medical appointments significantly increased from baseline to 3-month follow-up in the control group, while no significant change was observed in the combined WED group. Among the WED group, individuals assigned to write about their IBS experienced greater improvements in pain self-efficacy than those assigned to write about a life stressor, F(1,92) = 3.89, p = 0.024, η 2  = 0.08. GI symptom severity, HR-QOL, and pain catastrophizing improved significantly across groups over time, with no significant between-group differences. CONCLUSION Writing about one's deepest thoughts and feelings about IBS may increase pain self-efficacy and reduce healthcare utilization compared to control writing in adults with IBS.",2021,"GI symptom severity, HR-QOL, and pain catastrophizing improved significantly across groups over time, with no significant between-group differences. ","['Adults (N\xa0=\xa0189) meeting Rome III criteria for IBS', 'adults with irritable bowel syndrome', 'adults with IBS', 'irritable bowel syndrome (IBS']","['WED', 'WED vs. control']","['GI symptom severity, HR-QOL, and pain catastrophizing', 'pain self-efficacy', 'Gastrointestinal (GI) symptoms, healthcare utilization, health-related quality of life (HR-QOL), pain catastrophizing, and pain self-efficacy', 'number of GI-related medical appointments', 'pain self-efficacy and reduce healthcare utilization']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}]","[{'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",189.0,0.190479,"GI symptom severity, HR-QOL, and pain catastrophizing improved significantly across groups over time, with no significant between-group differences. ","[{'ForeName': 'Kelsey T', 'Initials': 'KT', 'LastName': 'Laird', 'Affiliation': 'Department of Psychiatry & Biobehavioral Sciences, Semel Institute for Neuroscience & Human Behavior, David Geffen School of Medicine at UCLA, Los Angeles, CA, 90095, USA; School of Professional Psychology and Health, California Institute of Integral Studies, San Francisco, CA, 94103, USA. Electronic address: kelsey@innerstrengthpsychotherapy.com.'}, {'ForeName': 'Annette L', 'Initials': 'AL', 'LastName': 'Stanton', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, USA. Electronic address: astanton@psych.ucla.edu.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101374'] 3037,33832142,Effects of functional movement screen training in high-school baseball players: A randomized controlled clinical trial.,"BACKGROUND In recent years, the functional movement screen (FMS) and FMS training have attracted attention as a means of preventing injury, but no studies have examined the effect of such training in high-school baseball players. The aim of this study was to clarify the effect of FMS training on FMS score, physical function and baseball performance in high-school baseball players. METHODS Subjects in this randomized controlled clinical trial were high-school male baseball players assigned to either an FMS training group (intervention group) or a control group. The intervention group performed FMS training 4 times per week for 12 weeks. FMS ability, physical function, and baseball performance were measured prior to the intervention, 8, 12, and 24 weeks after the intervention in the subjects' school environment. RESULTS A total of 71 baseball players aged 15 to 17 years were recruited and assigned to either an intervention group (n = 37) or control group (n = 34). There was no significant difference in the characteristics of participants between the 2 groups. Most FMS scores improved to 12 weeks after continued training. In the intervention group compared with the control group, deep squat, hurdle step, inline lunge, active straight leg raise, trunk stability push-up and rotary stability FMS score, total FMS score and eyes closed single leg stance time significantly increased after 8 weeks of training. While hurdle step, inline lunge, active straight leg raise, trunk stability push-up, total FMS score, and eyes closed single leg stance time significantly increased, pitching ball speed significantly decreased at the end of the 12 week training period. Eyes closed single leg stance time and feeling of fatigue significantly improved 12 weeks after training. The number of subjects who scored less than 14 for the total FMS score in the intervention group compared with control group were significantly less after 8 and 12 weeks of FMS training. CONCLUSION FMS training for 8 weeks contributes to improving FMS scores for high-school baseball players, but FMS scores go down if FMS training is not continued. TRIAL REGISTRATION University Hospital Medical Information Network Center, Tokyo, Japan: UMIN000027553. Registered on May 30, 2017.",2021,"The number of subjects who scored less than 14 for the total FMS score in the intervention group compared with control group were significantly less after 8 and 12 weeks of FMS training. ","['Subjects in this randomized controlled clinical trial were high-school male baseball players', 'University Hospital Medical Information Network Center, Tokyo, Japan', 'high-school baseball players', '71 baseball players aged 15 to 17\u200ayears']","['FMS training group (intervention group) or a control group', 'functional movement screen training', 'FMS training']","['FMS scores', 'single leg stance time and feeling of fatigue', 'While hurdle step, inline lunge, active straight leg raise, trunk stability push-up, total FMS score, and eyes closed single leg stance time', 'FMS ability, physical function, and baseball performance', 'Most FMS scores', 'FMS score, physical function and baseball performance', 'pitching ball speed', 'total FMS score', 'deep squat, hurdle step, inline lunge, active straight leg raise, trunk stability push-up and rotary stability FMS score, total FMS score and eyes closed single leg stance time']","[{'cui': 'C0936233', 'cui_str': 'Controlled Clinical Trial'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0004795', 'cui_str': 'Baseball'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021419', 'cui_str': 'Information Networks'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0040371', 'cui_str': 'Tokyo'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0422926', 'cui_str': 'Straight leg raise test response'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0004795', 'cui_str': 'Baseball'}, {'cui': 'C0175681', 'cui_str': 'Pitch'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}]",,0.0125337,"The number of subjects who scored less than 14 for the total FMS score in the intervention group compared with control group were significantly less after 8 and 12 weeks of FMS training. ","[{'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'Department of Rehabilitation, Saitama Medical University Saitama Medical Center, Kawagoe.'}, {'ForeName': 'Kiyokazu', 'Initials': 'K', 'LastName': 'Akasaka', 'Affiliation': ""Master's and Doctoral Program of Physical Therapy, Saitama Medical University Graduate School of Medicine.""}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Otsudo', 'Affiliation': ""Master's and Doctoral Program of Physical Therapy, Saitama Medical University Graduate School of Medicine.""}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Sawada', 'Affiliation': 'School of Physical Therapy, Saitama Medical University.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Hattori', 'Affiliation': ""Master's and Doctoral Program of Physical Therapy, Saitama Medical University Graduate School of Medicine.""}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Hasebe', 'Affiliation': 'Department of Rehabilitation, Saitama Medical University Saitama Medical Center, Kawagoe.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Mizoguchi', 'Affiliation': 'Department of Rehabilitation, Saitama Medical University Hospital, Moroyama, Saitama, Japan.'}, {'ForeName': 'Toby M', 'Initials': 'TM', 'LastName': 'Hall', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University.'}, {'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Rehabilitation, Saitama Medical University Saitama Medical Center, Kawagoe.'}]",Medicine,['10.1097/MD.0000000000025423'] 3038,33832116,"How to prophylactically alleviate postembolization syndrome following transarterial chemoembolization?: Protocol of a double blinded, randomized, placebo-controlled trial.","INTRODUCTION Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer, and most patients in China are diagnosed at the intermediate or later stages, which is not suitable for the first line therapies. Transarterial chemoembolization (TACE) is a commonly selected therapeutic option for intermediate and later stage HCC in China, but patients often suffer from postembolization syndrome (PES), manifesting as fever, liver area pain, nausea, vomiting, paralyzed intestinal obstruction, and abdominal pain after TACE. We try to conduct a double blinded, randomized, placebo-controlled clinical trial to observe whether Chaihu Guizhi decoction (CGD), a classic traditional Chinese formula, could prophylactically alleviate the incidence of PES in HCC patients after TACE. METHODS Patients will be randomly assigned sequentially in a 1:1 ratio by using preformed randomization envelopes. After TACE procedures, patients in the treatment group will be administrated with Chinese herbal formula CGD, and patients in the control group with CGD simulations, twice a day, continuously for 7 days. The outcomes are the incidence of PES hospitalization and, complications. SPSS version 22 (IBM, Chicago, IL) will be used for the data, and a P < .05 will be considered statistically significant. CONCLUSIONS The findings will explore the prophylactic effect of CGD in alleviating the incidence of PES following TACE in HCC patients. TRIAL REGISTRATION OSF Registration number: DOI 10.17605/OSF.IO/FKRSN.",2021,"SPSS version 22 (IBM, Chicago, IL) will be used for the data, and a P < .05 will be considered statistically significant. ","['Patients', 'OSF Registration number', 'HCC patients after TACE']","['CGD', 'Transarterial chemoembolization (TACE', 'Chinese herbal formula CGD', 'placebo', 'Chaihu Guizhi decoction (CGD']","['SPSS version 22 (IBM, Chicago, IL', 'incidence of PES hospitalization and, complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0522522', 'cui_str': 'Transarterial approach'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}]","[{'cui': 'C2353543', 'cui_str': 'guizhi decoction'}, {'cui': 'C0522522', 'cui_str': 'Transarterial approach'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0085292', 'cui_str': 'Stiff-man syndrome'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0238190', 'cui_str': 'Inclusion body myositis'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.666346,"SPSS version 22 (IBM, Chicago, IL) will be used for the data, and a P < .05 will be considered statistically significant. ","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': ""The Ninth People's Hospital of Chongqing.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Chang', 'Affiliation': 'Chongqing Orthopedic Hospital of Traditional Chinese Medicine, Chongqing, Chongqing City, China.'}, {'ForeName': 'Zhonglin', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': ""The Ninth People's Hospital of Chongqing.""}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Hong', 'Affiliation': ""The Ninth People's Hospital of Chongqing.""}]",Medicine,['10.1097/MD.0000000000025360'] 3039,33832100,Randomized clinical trial of preoperative skin preparation with 2% chlorhexidine versus conventional hair shaving in percutaneous coronary intervention.,"BACKGROUND Preoperative skin preparation is associated with surgical site infection (SSI). Traditional preoperative shaving fails to reduce the risk of SSI. The efficacy of 2% chlorhexidine for preoperative skin preparation in percutaneous coronary intervention (PCI) is sketchy. The aim of this trial was to evaluate whether preoperative skin preparation performed with chlorhexidine was not inferior to a conventional hair removal method. METHODS Seventy-eight patients undergoing PCI were randomized into 2 groups of 39 patients, receiving either single sterilization with 2% chlorhexidine or hair shaving respectively between July 2016 and October 2016. The primary endpoints were wound infection rate and bacterial counts. Secondary endpoints were rate of SSI and adverse effects of 2% chlorhexidine. RESULTS The results showed that 2% chlorhexidine significantly reduced the colonization of Staphylococcus aureus (P = .032), S epidermidis (P = .000), and miscellaneous bacteria (P = .244) in comparison with hair shaving, respectively. Redness in 24 hours after surgery was observed in 6 patients in the control group (15.4%) and 5 patients (12.8%) in 2% chlorhexidine group. There was no statistically significant difference in SSI rate between 2 skin preparations. CONCLUSION In PCI, preoperative skin preparation with 2% chlorhexidine was not inferior to conventional hair shaving in terms of the wound infection rate and SSI rate.",2021,"The results showed that 2% chlorhexidine significantly reduced the colonization of Staphylococcus aureus (P = .032), S epidermidis (P = .000), and miscellaneous bacteria (P = .244) in comparison with hair shaving, respectively.","['percutaneous coronary intervention (PCI', 'Seventy-eight patients undergoing PCI were randomized into 2 groups of 39 patients, receiving either', 'percutaneous coronary intervention']","['single sterilization with 2% chlorhexidine or hair shaving', 'chlorhexidine', 'preoperative skin preparation with 2% chlorhexidine']","['Redness', 'risk of SSI', 'miscellaneous bacteria', 'rate of SSI and adverse effects of 2% chlorhexidine', 'colonization of Staphylococcus aureus', 'wound infection rate and SSI rate', 'wound infection rate and bacterial counts', 'S epidermidis', 'SSI rate']","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0038280', 'cui_str': 'Sterilization'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0518505', 'cui_str': 'Does shave'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0455085', 'cui_str': 'Skin preparation'}]","[{'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0205395', 'cui_str': 'Miscellaneous'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0004618', 'cui_str': 'Bacterial count'}]",78.0,0.123016,"The results showed that 2% chlorhexidine significantly reduced the colonization of Staphylococcus aureus (P = .032), S epidermidis (P = .000), and miscellaneous bacteria (P = .244) in comparison with hair shaving, respectively.","[{'ForeName': 'Hsueh-Ya', 'Initials': 'HY', 'LastName': 'Tsai', 'Affiliation': 'Department of Nursing, Chung Shan Medical University Hospital.'}, {'ForeName': 'Wen-Chun', 'Initials': 'WC', 'LastName': 'Liao', 'Affiliation': 'School of Nursing, China Medical University, Department of Nursing, China Medical University Hospital.'}, {'ForeName': 'Meilin', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Microbiology and Immunology, School of Medicine, Chung Shan Medical University.'}, {'ForeName': 'Kwo-Chang', 'Initials': 'KC', 'LastName': 'Ueng', 'Affiliation': 'School of Medicine, Chung Shan Medical University.'}, {'ForeName': 'Cheng-Yi', 'Initials': 'CY', 'LastName': 'Huang', 'Affiliation': 'School of Nursing, Chung Shan Medical University, Chung Shan Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Ying-Chen', 'Initials': 'YC', 'LastName': 'Tseng', 'Affiliation': 'School of Nursing, Chung Shan Medical University, Chung Shan Medical University Hospital, Taichung, Taiwan.'}]",Medicine,['10.1097/MD.0000000000025304'] 3040,33832092,Repetitive transcranial magnetic stimulation in major depression: A three-arm parallel-group dose-response randomized pilot trial.,"BACKGROUND The optimal dose (number of pulses per session) of repetitive transcranial magnetic stimulation (rTMS), using the H-coil, in major depressive disorder (MDD) has not previously been reported. OBJECTIVE To explore the relationship between rTMS dose and antidepressant effect, and collect data for the design of a definitive trial. METHODS This was a double-blind, three-arm parallel-group, randomized [1:1:1], pilot trial conducted in Stockholm, Sweden (September 2014 to September 2016). The primary outcome was change in depression severity measured with the Montgomery Åsberg Depression Rating Scale (MADRS) after 4 weeks. Participants (n = 29) with MDD were randomized to 1000, 2000, or 4000 pulses of rTMS for 20 sessions during 4 weeks. RESULTS At 4 weeks, the 3 treatment groups reduced the mean MADRS (95% CI) by 11.6 (4.0-19.2), 9.1 (5.0-13.3), and 11.3 (4.1-18.5) points respectively. Eleven participants met criteria for response and 10 for remission. No serious adverse events occurred. Ratings of subjective memory improved in all groups. Exploring the effect of dose and time, 4000 pulses had the largest reduction in MADRS during the first 2 weeks. A comparison of change in MADRS between 2000 and 4000 pulses after 2 weeks will require a sample size of 66 patients at power .80 and alpha .05. CONCLUSIONS It is feasible to conduct a definitive trial investigating whether a higher number of magnetic pulses per treatment session gives a more rapid antidepressive response.",2021,"At 4 weeks, the 3 treatment groups reduced the mean MADRS (95% CI) by 11.6 (4.0-19.2), 9.1 (5.0-13.3), and 11.3 (4.1-18.5) points respectively.","['Stockholm, Sweden (September 2014 to September 2016', 'Participants (n\u200a=\u200a29) with MDD', 'Eleven participants met criteria for response and 10 for remission', 'major depression']","['repetitive transcranial magnetic stimulation (rTMS', 'Repetitive transcranial magnetic stimulation', 'rTMS']","['mean MADRS', 'change in depression severity measured with the Montgomery Åsberg Depression Rating Scale (MADRS', 'MADRS', 'Ratings of subjective memory']","[{'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",,0.180158,"At 4 weeks, the 3 treatment groups reduced the mean MADRS (95% CI) by 11.6 (4.0-19.2), 9.1 (5.0-13.3), and 11.3 (4.1-18.5) points respectively.","[{'ForeName': 'Kristoffer', 'Initials': 'K', 'LastName': 'Johansson', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Adler', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet.'}, {'ForeName': 'Ullvi', 'Initials': 'U', 'LastName': 'Båve', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet.'}, {'ForeName': 'Carl-Johan', 'Initials': 'CJ', 'LastName': 'Ekman', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Lundberg', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet.'}]",Medicine,['10.1097/MD.0000000000025273'] 3041,33831950,The effect of intermittent energy restriction on weight loss and diabetes risk markers in women with a history of gestational diabetes: a 12-month randomized control trial.,"BACKGROUND Weight loss after gestational diabetes (GDM) can prevent or delay the onset of type 2 diabetes. Intermittent energy restriction (IER) may offer an alternative to continuous energy restriction (CER) for weight loss. OBJECTIVES We compared the effects of IER (2 days per week) to daily CER over 12 mo on weight loss and diabetes risk markers in overweight women with previous GDM. METHODS Overweight females (n = 121) ≥18 y were randomized 1:1 to either IER [2-d 500 kcal (2100 kJ); n = 61] or CER [1500 kcal (6000 kJ); n = 60] in this 12-mo noninferiority trial. RESULTS The trial was completed by 62 participants with a median age of 39.6 y [Quartile (Q) 1 to Quartile 3, 34.9 to 43.9 y] with a median BMI of 32.6 kg/m2 (Q1 to Q3, 28.5 to 37.9 kg/m2) at a median of 2.9 y after GDM (Q1 to Q3, 2.1 to 6.4 y; 49% attrition; IER n = 29; CER n = 30; P = 0.8). The mean ± SD weight loss was significant over time (P < 0.001) but not by diet group (IER -4.8 ± 5.0 kg; CER -3.2 ± 5.0; P = 0.2). The mean between-group difference was -1.6 kg (95% CI: -4.2 to 1.0 kg; P = 0.2). There were no significant between-group differences in change in HbA1c, fasting plasma glucose, fasting serum insulin, HOMA-IR or 2-h oral glucose tolerance at 12 mo (p>0.05). The trial was registered at https://www.anzctr.org.au/ (ACTRN12617001476325). CONCLUSIONS IER produces comparable weight loss to CER over 12 mo in overweight women with previous GDM. The high dropout rate in this study is a limitation in the interpretation of these results. Larger studies are needed to confirm noninferiority of IER compared to CER.",2021,"There were no significant between-group differences in change in HbA1c, fasting plasma glucose, fasting serum insulin, HOMA-IR or 2-h oral glucose tolerance at 12 mo (p>0.05).","['62 participants with a median age of 39.6 y [Quartile (Q) 1 to Quartile 3, 34.9 to 43.9 y] with a median BMI of 32.6 kg/m2 (Q1 to Q3, 28.5 to 37.9 kg/m2) at a median of 2.9 y after GDM (Q1 to Q3, 2.1 to 6.4 y; 49% attrition; IER n\xa0=\xa029; CER n\xa0=\xa030; P\xa0=\xa00.8', 'overweight women with previous GDM', 'Overweight females (n\xa0=\xa0121) ≥18', 'women with a history of gestational diabetes']","['IER [2-d 500 kcal (2100 kJ); n\xa0=\xa061] or CER', 'IER', 'intermittent energy restriction', 'Intermittent energy restriction (IER']","['weight loss and diabetes risk markers', 'mean\xa0±\xa0SD weight loss', 'change in HbA1c, fasting plasma glucose, fasting serum insulin, HOMA-IR or 2-h oral glucose tolerance', 'weight loss to CER']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C4517641', 'cui_str': '2.9'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]",,0.107052,"There were no significant between-group differences in change in HbA1c, fasting plasma glucose, fasting serum insulin, HOMA-IR or 2-h oral glucose tolerance at 12 mo (p>0.05).","[{'ForeName': 'Kristy L', 'Initials': 'KL', 'LastName': 'Gray', 'Affiliation': 'University of South Australia, Clinical and Health Sciences, Adelaide, Australia.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Clifton', 'Affiliation': 'University of South Australia, Clinical and Health Sciences, Adelaide, Australia.'}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'Keogh', 'Affiliation': 'University of South Australia, Clinical and Health Sciences, Adelaide, Australia.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqab058'] 3042,33250386,"Abuse liability assessment of the JUUL system in two nicotine concentrations compared to combustible cigarette, nicotine gum and comparator electronic nicotine delivery system.","BACKGROUND To assess the abuse liability of the JUUL System (JS) in 5.0 % (59 mg/mL) and 3.0 % (35 mg/mL) nicotine concentrations. METHODS Adult smokers (N = 146; 45.9 % female; mean age = 41.29 years) were randomized to one of four study flavor arms and then to a within-subjects cross-over sequence for five test product categories: (1) JS 5.0 % nicotine concentration; (2) JS 3.0 % nicotine; (3) usual brand (UB) cigarette; (4) 4 mg mint nicotine gum; (5) comparator ENDS (VUSE Alto 5.0 % nicotine). Products were tested by ad libitum use (5 min for ENDS and cigarette; 30 min for gum); nicotine pharmacokinetic (PK) parameters and subjective effects were assessed following use. RESULTS Maximum plasma nicotine concentration (C max-BL ), rate of plasma nicotine rise and total nicotine exposure (AUC 0-60-BL ) of UB cigarette were significantly greater than all other test products. The comparator ENDS was significantly greater than 5.0 % and 3.0 % JS and nicotine gum on C max-BL , rate of plasma nicotine rise, and AUC 0-60-BL ; C max-BL of JS 5.0 % was significantly greater than JS 3.0 % and nicotine gum. Product liking and satisfying effects were significantly highest for the UB cigarette; JS products and comparator ENDS did not significantly differ and were rated higher than nicotine gum on most subjective measures. CONCLUSIONS These results suggest that the abuse liability of both 5.0 % and 3.0 % JS is: (1) substantially lower than UB cigarette; (2) somewhat lower than comparator ENDS; and (3) higher than nicotine gum. Additionally, the abuse liability of JS 5.0 % is somewhat higher than JS 3.0 %.",2020,"Product liking and satisfying effects were significantly highest for the UB cigarette; JS products and comparator ENDS did not significantly differ and were rated higher than nicotine gum on most subjective measures. ",['Adult smokers (N = 146; 45.9 % female; mean age = 41.29 years'],['JS 5.0 % nicotine concentration; (2) JS 3.0 % nicotine; (3) usual brand (UB) cigarette; (4) 4 mg mint nicotine gum; (5) comparator ENDS '],"['Product liking and satisfying effects', 'C max-BL , rate of plasma nicotine rise, and AUC 0-60-BL ; C max-BL of JS', 'abuse liability', 'Maximum plasma nicotine concentration (C max-BL ), rate of plasma nicotine rise and total nicotine exposure (AUC 0-60-BL ) of UB cigarette']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0452249', 'cui_str': 'Mint'}, {'cui': 'C0599654', 'cui_str': 'Nicotine Chewing Gum'}, {'cui': 'C0444930', 'cui_str': 'End'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]",,0.0089816,"Product liking and satisfying effects were significantly highest for the UB cigarette; JS products and comparator ENDS did not significantly differ and were rated higher than nicotine gum on most subjective measures. ","[{'ForeName': 'Nicholas I', 'Initials': 'NI', 'LastName': 'Goldenson', 'Affiliation': 'Juul Labs, Inc., United States. Electronic address: nicholas.goldenson@juul.com.'}, {'ForeName': 'August R', 'Initials': 'AR', 'LastName': 'Buchhalter', 'Affiliation': 'PinneyAssociates, Inc., United States.'}, {'ForeName': 'Erik M', 'Initials': 'EM', 'LastName': 'Augustson', 'Affiliation': 'Juul Labs, Inc., United States.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Rubinstein', 'Affiliation': 'Juul Labs, Inc., United States.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Van Hoof', 'Affiliation': 'Juul Labs, Inc., United States.'}, {'ForeName': 'Jack E', 'Initials': 'JE', 'LastName': 'Henningfield', 'Affiliation': 'PinneyAssociates, Inc., United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108441'] 3043,33249492,Digital cognitive behavioral therapy for insomnia promotes later health resilience during the coronavirus disease 19 (COVID-19) pandemic.,"STUDY OBJECTIVES Stressful life events contribute to insomnia, psychosocial functioning, and illness. Though individuals with a history of insomnia may be especially vulnerable during stressful life events, risk may be mitigated by prior intervention. This study evaluated the effect of prior digital cognitive-behavioral therapy for insomnia (dCBT-I) versus sleep education on health resilience during the COVID-19 pandemic. METHODS COVID impact, insomnia, general- and COVID-related stress, depression, and global health were assessed in April 2020 in adults with a history of insomnia who completed a randomized controlled trial of dCBT-I (n = 102) versus sleep education control (n = 106) in 2016-2017. Regression analyses were used to evaluate the effect of intervention conditions on subsequent stress and health during the pandemic. RESULTS Insomnia symptoms were significantly associated with COVID-19 related disruptions, and those who previously received dCBT-I reported less insomnia symptoms, less general stress and COVID-related cognitive intrusions, less depression, and better global health than those who received sleep education. Moreover, the odds for resurgent insomnia was 51% lower in the dCBT-I versus control condition. Similarly, odds of moderate to severe depression during COVID-19 was 57% lower in the dCBT-I condition. CONCLUSIONS Those who received dCBT-I had increased health resilience during the COVID-19 pandemic in adults with a history of insomnia and ongoing mild to moderate mental health symptoms. These data provide evidence that dCBT-I is a powerful tool to promote mental and physical health during stressors, including the COVID-19 pandemic. CLINICAL TRIAL REGISTRATION NCT02988375.",2021,"RESULTS Insomnia symptoms were significantly associated with COVID-19 related disruptions, and those previously received dCBT-I reported less insomnia symptoms, less general stress and COVID-related cognitive intrusions, less depression, and better global health than those who received sleep education.","['April 2020 in adults with a history of insomnia who completed a randomized controlled trial of dCBT-I (n = 102) versus', 'adults with a history of insomnia and ongoing mild to moderate mental health symptoms', 'n = 106) in 2016-2017']","['digital cognitive-behavioral therapy for insomnia (dCBT-I) versus sleep education', 'Digital Cognitive Behavioral Therapy', 'sleep education control', 'dCBT']","['resurgent insomnia', 'insomnia, general- and COVID-related stress, depression, and global health', 'insomnia symptoms', 'Later Health Resilience', 'general stress and COVID-related cognitive intrusions, less depression, and better global health', 'health resilience', 'severe depression', 'Insomnia symptoms']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0588008', 'cui_str': 'Severe depression'}]",,0.0369317,"RESULTS Insomnia symptoms were significantly associated with COVID-19 related disruptions, and those previously received dCBT-I reported less insomnia symptoms, less general stress and COVID-related cognitive intrusions, less depression, and better global health than those who received sleep education.","[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Cheng', 'Affiliation': 'Sleep Disorders and Research Center, Henry Ford Health System, Detroit, MI.'}, {'ForeName': 'Melynda D', 'Initials': 'MD', 'LastName': 'Casement', 'Affiliation': 'Department of Psychology, University of Oregon, Eugene, OR.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kalmbach', 'Affiliation': 'Sleep Disorders and Research Center, Henry Ford Health System, Detroit, MI.'}, {'ForeName': 'Andrea Cuamatzi', 'Initials': 'AC', 'LastName': 'Castelan', 'Affiliation': 'Sleep Disorders and Research Center, Henry Ford Health System, Detroit, MI.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Drake', 'Affiliation': 'Sleep Disorders and Research Center, Henry Ford Health System, Detroit, MI.'}]",Sleep,['10.1093/sleep/zsaa258'] 3044,33252671,Hospital Consultation From Outpatient Clinicians for Medically Complex Children: A Randomized Clinical Trial.,"Importance Children with medical complexity (CMC) frequently experience fragmented care. We have demonstrated that outpatient comprehensive care (CC) reduces serious illnesses, hospitalizations, and costs for high-risk CMC. Yet continuity of care for CMC is often disrupted with emergency department (ED) visits and hospitalizations. Objective To evaluate a hospital consultation (HC) service for CMC from their outpatient CC clinicians. Design, Setting, and Participants Randomized quality improvement trial at the University of Texas Health Science Center at Houston with an outpatient CC clinic and tertiary pediatric hospital (Children's Memorial Hermann Hospital). Participants included high-risk CMC (≥2 hospitalizations or ≥1 pediatric intensive care unit [PICU] admission in the year before enrolling in our clinic) receiving CC. Data were analyzed between January 11, 2018, and December 20, 2019. Interventions The HC included serial discussions between CC clinicians, ED physicians, and hospitalists addressing need for admission, inpatient treatment, and transition back to outpatient care. Usual hospital care (UHC) involved routine pediatric hospitalist care. Main Outcomes and Measures Total hospital days (primary outcome), PICU days, hospitalizations, and health system costs in skeptical bayesian analyses (using a prior probability assuming no benefit). Results From October 3, 2016, through October 2, 2017, 342 CMC were randomized to either HC (n = 167) or UHC (n = 175) before meeting the predefined bayesian stopping guideline (>80% probability of reduced hospital days). In intention-to-treat analyses, the probability that HC reduced total hospital days was 91% (2.72 vs 6.01 per child-year; bayesian rate ratio [RR], 0.61; 95% credible interval [CrI], 0.30-1.26). The probability of a reduction with HC vs UHC was 98% for hospitalizations (0.60 vs 0.93 per child-year; RR, 0.68; 95% CrI, 0.48-0.97), 89% for PICU days (0.77 vs 1.89 per child-year; RR, 0.59; 95% CrI, 0.26-1.38), and 94% for mean total health system costs ($24 928 vs $42 276 per child-year; cost ratio, 0.67; 95% CrI, 0.41-1.10). In secondary analysis using a bayesian prior centered at RR of 0.78, reflecting the opinion of 7 experts knowledgeable about CMC, the probability that HC reduced hospital days was 96%. Conclusions and Relevance Among CMC receiving comprehensive outpatient care, an HC service from outpatient clinicians likely reduced total hospital days, hospitalizations, PICU days, other outcomes, and health system costs. Additional trials of an HC service from outpatient CC clinicians are needed for CMC in other centers. Trial Registration ClinicalTrials.gov Identifier: NCT02870387.",2021,"In intention-to-treat analyses, the probability that HC reduced total hospital days was 91% (2.72 vs 6.01 per child-year; bayesian rate ratio [RR], 0.61; 95% credible interval [CrI], 0.30-1.26).","[""University of Texas Health Science Center at Houston with an outpatient CC clinic and tertiary pediatric hospital (Children's Memorial Hermann Hospital"", 'Importance\n\n\nChildren with medical complexity (CMC', 'Participants included high-risk CMC (≥2 hospitalizations or ≥1 pediatric intensive care unit [PICU] admission in the year before enrolling in our clinic) receiving', 'Medically Complex Children', 'Results\n\n\nFrom October 3, 2016, through October 2, 2017, 342 CMC']","['UHC', 'CC', 'HC', 'Usual hospital care (UHC', 'hospital consultation (HC) service']","['total hospital days, hospitalizations, PICU days, other outcomes, and health system costs', 'probability that HC reduced total hospital days', 'mean total health system costs', 'Measures\n\n\nTotal hospital days (primary outcome), PICU days, hospitalizations, and health system costs in skeptical bayesian analyses (using a prior probability assuming no benefit']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0009586', 'cui_str': 'Comprehensive Healthcare'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C5191280', 'cui_str': '342'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009586', 'cui_str': 'Comprehensive Healthcare'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0587438', 'cui_str': 'Day hospital'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0242196', 'cui_str': 'Analysis, Bayesian'}, {'cui': 'C0332152', 'cui_str': 'Before'}]",342.0,0.140731,"In intention-to-treat analyses, the probability that HC reduced total hospital days was 91% (2.72 vs 6.01 per child-year; bayesian rate ratio [RR], 0.61; 95% credible interval [CrI], 0.30-1.26).","[{'ForeName': 'Ricardo A', 'Initials': 'RA', 'LastName': 'Mosquera', 'Affiliation': 'Department of Pediatrics, McGovern Medical School, The University of Texas Health Science Center at Houston.'}, {'ForeName': 'Elenir B C', 'Initials': 'EBC', 'LastName': 'Avritscher', 'Affiliation': 'Department of Pediatrics, McGovern Medical School, The University of Texas Health Science Center at Houston.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pedroza', 'Affiliation': 'Department of Pediatrics, McGovern Medical School, The University of Texas Health Science Center at Houston.'}, {'ForeName': 'Cynthia S', 'Initials': 'CS', 'LastName': 'Bell', 'Affiliation': 'Department of Pediatrics, McGovern Medical School, The University of Texas Health Science Center at Houston.'}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Samuels', 'Affiliation': 'Department of Pediatrics, McGovern Medical School, The University of Texas Health Science Center at Houston.'}, {'ForeName': 'Tomika S', 'Initials': 'TS', 'LastName': 'Harris', 'Affiliation': 'Department of Pediatrics, McGovern Medical School, The University of Texas Health Science Center at Houston.'}, {'ForeName': 'Julie C', 'Initials': 'JC', 'LastName': 'Eapen', 'Affiliation': 'Department of Pediatrics, McGovern Medical School, The University of Texas Health Science Center at Houston.'}, {'ForeName': 'Aravind', 'Initials': 'A', 'LastName': 'Yadav', 'Affiliation': 'Department of Pediatrics, McGovern Medical School, The University of Texas Health Science Center at Houston.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Poe', 'Affiliation': 'Department of Pediatrics, McGovern Medical School, The University of Texas Health Science Center at Houston.'}, {'ForeName': 'Raymond L', 'Initials': 'RL', 'LastName': 'Parlar-Chun', 'Affiliation': 'Department of Pediatrics, McGovern Medical School, The University of Texas Health Science Center at Houston.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Berry', 'Affiliation': ""Complex Care Service, Division of General Pediatrics, Boston Children's Hospital, Department of Pediatrics, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Jon E', 'Initials': 'JE', 'LastName': 'Tyson', 'Affiliation': 'Department of Pediatrics, McGovern Medical School, The University of Texas Health Science Center at Houston.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2020.5026'] 3045,33256392,Ixazomib-Thalidomide-low dose dexamethasone induction followed by maintenance therapy with ixazomib or placebo in newly diagnosed multiple myeloma patients not eligible for autologous stem cell transplantation; results from the randomized phase II HOVON-126/NMSG 21.13 trial.,,2020,,['newly diagnosed multiple myeloma patients not eligible for autologous stem cell transplantation'],"['ixazomib or placebo', 'Ixazomib-Thalidomide-low dose dexamethasone']",[],"[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}]","[{'cui': 'C3273711', 'cui_str': 'ixazomib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]",[],,0.0374484,,"[{'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Zweegman', 'Affiliation': 'Amsterdam University Medical Center, Location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Claudia A M', 'Initials': 'CAM', 'LastName': 'Stege', 'Affiliation': 'Amsterdam University Medical Center, Location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Einar', 'Initials': 'E', 'LastName': 'Haukas', 'Affiliation': 'Stavanger University Hospital-Rogaland Hospital, Stavanger, Norway.'}, {'ForeName': 'Fredrik H', 'Initials': 'FH', 'LastName': 'Schjesvold', 'Affiliation': 'Oslo Myeloma Center, Oslo, Norway.'}, {'ForeName': 'Mark-David', 'Initials': 'MD', 'LastName': 'Levin', 'Affiliation': 'Albert Schweitzer Hospital, Dordrecht, the Netherlands.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Waage', 'Affiliation': 'St Olavs Hospital and Norwegian University of Science, Trondheim, Norway.'}, {'ForeName': 'Rineke B L', 'Initials': 'RBL', 'LastName': 'Leys', 'Affiliation': 'Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'Saskia K', 'Initials': 'SK', 'LastName': 'Klein', 'Affiliation': 'Meander Medical Center, Amersfoort, the Netherlands.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Szatkowski', 'Affiliation': 'Førde Central Hospital, Førde, Norway.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Axelsson', 'Affiliation': 'Skanes University Hospital Lund, Scania, Sweden.'}, {'ForeName': 'Trung', 'Initials': 'T', 'LastName': 'Hieu Do', 'Affiliation': 'Herlev Hospital, Herlev, Denmark.'}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Knut-Bojanowska', 'Affiliation': 'NU-Hospital, Uddevalla Hospital, Uddevalla, Sweden.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'van der Spek', 'Affiliation': 'Rijnstate Hospital, Arnhem, the Netherlands.'}, {'ForeName': 'Asta', 'Initials': 'A', 'LastName': 'Svirskaite', 'Affiliation': 'Aalborg Hospital, Aalborg, Denmark.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Klostergaard', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Salomo', 'Affiliation': 'Rigshospitalet Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Blimark', 'Affiliation': 'Sahlgrenska University Hospital, Gothenburg Sweden.'}, {'ForeName': 'Paula F', 'Initials': 'PF', 'LastName': 'Ypma', 'Affiliation': 'Haga Hospital, Den Haag, the Netherlands.'}, {'ForeName': 'Ulf-Henrik', 'Initials': 'UH', 'LastName': 'Mellqvist', 'Affiliation': 'Sodra Alvsborgs Sjukhus Boras, Boras, Sweden.'}, {'ForeName': 'Pino J', 'Initials': 'PJ', 'LastName': 'Poddighe', 'Affiliation': 'Amsterdam University Medical Center, Location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Stevens-Kroef', 'Affiliation': 'Radboud Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Niels W C J', 'Initials': 'NWCJ', 'LastName': 'van de Donk', 'Affiliation': 'Amsterdam University Medical Center, Location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Sonneveld', 'Affiliation': 'Erasmus Medical Center Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Hansson', 'Affiliation': 'Skanes University Hospital Lund, Scania, Sweden.'}, {'ForeName': 'Bronno', 'Initials': 'B', 'LastName': 'van der Holt', 'Affiliation': 'Erasmus Medical Center Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Abildgaard', 'Affiliation': 'Department of Haematology, AgeCare, Odense University Hospital, Odense, Denmark.'}]",Haematologica,['10.3324/haematol.2019.240374'] 3046,33258114,Impact of lanadelumab on health-related quality of life in patients with hereditary angioedema in the HELP study.,"BACKGROUND An objective of the phase 3 HELP Study was to investigate the effect of lanadelumab on health-related quality of life (HRQoL) in patients with hereditary angioedema (HAE). METHODS Patients with HAE-1/2 received either lanadelumab 150 mg every 4 weeks (q4wks; n = 28), 300 mg q4wks (n = 29), 300 mg every 2 weeks (q2wks; n = 27), or placebo (n = 41) for 26 weeks (days 0-182). The Angioedema Quality of Life Questionnaire (AE-QoL) was administered monthly, consisting of four domain (functioning, fatigue/mood, fears/shame, nutrition) and total scores. The generic EQ-5D-5L questionnaire was administered on days 0, 98, and 182. Comparisons were made between placebo and (a) all lanadelumab-treated patients and (b) individual lanadelumab groups for changes in scores (day 0-182) and proportions achieving the minimal clinically important difference (MCID, -6) in AE-QoL total score. RESULTS Compared with the placebo group, the lanadelumab total group demonstrated significantly greater improvements in AE-QoL total and domain scores (mean change, -13.0 to -29.3; p < 0.05 for all); the largest improvement was in functioning. A significantly greater proportion of the lanadelumab total group achieved the MCID (70% vs 37%; p = 0.001). The lanadelumab 300 mg q2wks group had the highest proportion (81%; p = 0.001) and was 7.2 times more likely to achieve the MCID than the placebo group. Mean EQ-5D-5L scores at day 0 were high in all groups, indicating low impairment, with no significant changes at day 182. CONCLUSION Patients with HAE-1/2 experienced significant and clinically meaningful improvements in HRQoL measured by AE-QoL following lanadelumab treatment in the HELP Study.",2021,The lanadelumab 300 mg q2wks group had the highest proportion (81%; P=.001) and was 7.2 times more likely to achieve the MCID than the placebo group.,"['patients with hereditary angioedema in the HELP Study', 'Patients with HAE-1/2 received either', 'patients with hereditary angioedema (HAE']","['lanadelumab', 'placebo']","['MCID', 'Mean EQ-5D-5L scores', 'health-related quality of life (HRQoL', 'Angioedema Quality of Life Questionnaire (AE-QoL', 'HRQoL', 'health-related quality of life', 'AE-QoL total and domain scores', 'generic EQ-5D-5L questionnaire', 'proportions achieving the minimal clinically important difference (MCID, -6) in AE-QoL total score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019243', 'cui_str': 'Hereditary angioedema'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0580272', 'cui_str': '1/2'}]","[{'cui': 'C4505508', 'cui_str': 'lanadelumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002994', 'cui_str': 'Angioedema'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C4277733', 'cui_str': 'Minimal Clinically Important Difference'}]",,0.0794152,The lanadelumab 300 mg q2wks group had the highest proportion (81%; P=.001) and was 7.2 times more likely to achieve the MCID than the placebo group.,"[{'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Lumry', 'Affiliation': 'Allergy Asthma Research Associates Research Center, Dallas, TX, USA.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Weller', 'Affiliation': 'Dermatological Allergology, Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Magerl', 'Affiliation': 'Dermatological Allergology, Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Aleena', 'Initials': 'A', 'LastName': 'Banerji', 'Affiliation': 'Division of Rheumatology, Allergy and Immunology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Hilary J', 'Initials': 'HJ', 'LastName': 'Longhurst', 'Affiliation': ""Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, and University College London Hospitals, London, UK.""}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Riedl', 'Affiliation': 'Division of Rheumatology, Allergy & Immunology, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Hannah B', 'Initials': 'HB', 'LastName': 'Lewis', 'Affiliation': 'ICON plc, London, UK.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Lu', 'Affiliation': 'Takeda Pharmaceutical Company Limited, Lexington, MA, USA.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Devercelli', 'Affiliation': 'Takeda Pharmaceutical Company Limited, Lexington, MA, USA.'}, {'ForeName': 'Gagan', 'Initials': 'G', 'LastName': 'Jain', 'Affiliation': 'Takeda Pharmaceutical Company Limited, Lexington, MA, USA.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Maurer', 'Affiliation': 'Dermatological Allergology, Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Allergy,['10.1111/all.14680'] 3047,33258047,[Proton beam therapy versus intensity-modulated radiation therapy for locally advanced esophageal cancer: a randomized phase IIB trial].,,2021,,['locally advanced esophageal cancer'],['Proton beam therapy versus intensity-modulated radiation therapy'],[],"[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}]","[{'cui': 'C0436226', 'cui_str': 'Proton therapy'}, {'cui': 'C1512814', 'cui_str': 'Intensity modulated radiation therapy'}]",[],,0.0498787,,"[{'ForeName': 'Mechthild', 'Initials': 'M', 'LastName': 'Krause', 'Affiliation': 'Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Anstalt des öffentlichen Rechts des Freistaates Sachsen, Fetscherstraße\xa074, 01307, Dresden, Deutschland. mechthild.krause@uniklinikum-dresden.de.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-020-01714-9'] 3048,33823423,Effect of a group music intervention on cognitive function and mental health outcomes among nursing home residents: A randomized controlled pilot study.,"The purpose of this study was to determine the effect of a group music intervention with rhythmic exercises program on cognitive function and mental health outcomes among Korean nursing home residents . A randomized controlled study design was employed, in which the experimental group (n = 20) received a biweekly group music intervention with rhythmic exercises program and a regular activities program for 12 weeks, and the control group (n = 20) received only a regular activities program provided by the nursing home. We measured cognitive function and mental health outcomes using the Mini-Mental State Examination-Korean Version (MMSE-K), Geriatric Depression Scale Short Form-Korean Version (GDSSF-K), Geriatric Anxiety Inventory-Korean Version (GAI-K), and Life Satisfaction Scale. ANCOVA was performed to examine the effect of the group music intervention on the study variables. The results suggested that the group music intervention with rhythmic exercises program improved cognitive function, depression, anxiety, and life satisfaction.",2021,"The results suggested that the group music intervention with rhythmic exercises program improved cognitive function, depression, anxiety, and life satisfaction.","['experimental group (n\xa0=\xa020', 'Korean nursing home residents ', 'nursing home residents']","['biweekly group music intervention with rhythmic exercises program and a regular activities program for 12 weeks, and the control group (n\xa0=\xa020) received only a regular activities program provided by the nursing home', 'group music intervention', 'rhythmic exercises program']","['cognitive function, depression, anxiety, and life satisfaction', 'cognitive function and mental health outcomes using the Mini-Mental State Examination-Korean Version (MMSE-K), Geriatric Depression Scale Short Form-Korean Version (GDSSF-K), Geriatric Anxiety Inventory-Korean Version (GAI-K), and Life Satisfaction Scale', 'cognitive function and mental health outcomes']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C2919619', 'cui_str': 'Geriatric depression scale short form'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.00979682,"The results suggested that the group music intervention with rhythmic exercises program improved cognitive function, depression, anxiety, and life satisfaction.","[{'ForeName': 'Hyun-Sil', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, Daegu Haany University, 136, Sincheondae-ro, Susung-gu, Daegu 42158, South Korea. Electronic address: hskim@dhu.ac.kr.'}, {'ForeName': 'Jin-Suk', 'Initials': 'JS', 'LastName': 'Kang', 'Affiliation': 'Department of Health & Social Welfare for the Elderly, Daegu Haany University, Graduate School, Gyeongsan city, Gyeongsanbuk-do 38610, South Korea. Electronic address: jinsuk9042@naver.com.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2021.03.012'] 3049,33823421,A multidisciplinary Telehealth approach for community dwelling older adults.,"Telemedicine may be used for the continuity of care in several chronic conditions. Sixty frail old people were enrolled along with their primary caregivers, and randomly divided into two groups: 30 of them received a multi-specialist telemedicine care, whilst the other 30 were treated in their usual territory care. All of the patients were evaluated through a clinical and psychometric battery at baseline (T0), after 6 months (T1), and at the end of the study (T2). It was found that telemedicine was more effective than the traditional approach in mood improvement (p < 0.001), behaviour (p < 0.01) and ADL/IADL (p < 0.01/0.04), as well as nutritional status. These changes increased over time (from T0 to T1), the caregivers' burden decreased, and system usability was rated as good. Telemedicine could be considered an important tool to improve the psychological health and quality of the life of older frail patients living at home.",2021,It was found that telemedicine was more effective than the traditional approach in mood improvement (,"['older frail patients living at home', 'Sixty frail old people were enrolled along with their primary caregivers', 'community dwelling older adults']","['multi-specialist telemedicine care', 'telemedicine', 'Telemedicine']","['system usability', 'mood improvement ', 'ADL/IADL', 'behaviour']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1319883', 'cui_str': 'Primary caregiver'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",60.0,0.0119598,It was found that telemedicine was more effective than the traditional approach in mood improvement (,"[{'ForeName': 'Rosaria', 'Initials': 'R', 'LastName': 'De Luca', 'Affiliation': 'Rocco Salvatore Calabrò, IRCCS Centro Neurolesi ""Bonino-Pulejo"", S.S. 113, Contrada Casazza, 98124 Messina, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Torrisi', 'Affiliation': 'Rocco Salvatore Calabrò, IRCCS Centro Neurolesi ""Bonino-Pulejo"", S.S. 113, Contrada Casazza, 98124 Messina, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Bramanti', 'Affiliation': 'Rocco Salvatore Calabrò, IRCCS Centro Neurolesi ""Bonino-Pulejo"", S.S. 113, Contrada Casazza, 98124 Messina, Italy.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Maggio', 'Affiliation': 'Rocco Salvatore Calabrò, IRCCS Centro Neurolesi ""Bonino-Pulejo"", S.S. 113, Contrada Casazza, 98124 Messina, Italy.'}, {'ForeName': 'Smeralda', 'Initials': 'S', 'LastName': 'Anchesi', 'Affiliation': 'Rocco Salvatore Calabrò, IRCCS Centro Neurolesi ""Bonino-Pulejo"", S.S. 113, Contrada Casazza, 98124 Messina, Italy.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Andaloro', 'Affiliation': 'Rocco Salvatore Calabrò, IRCCS Centro Neurolesi ""Bonino-Pulejo"", S.S. 113, Contrada Casazza, 98124 Messina, Italy.'}, {'ForeName': 'Santina', 'Initials': 'S', 'LastName': 'Caliri', 'Affiliation': 'Rocco Salvatore Calabrò, IRCCS Centro Neurolesi ""Bonino-Pulejo"", S.S. 113, Contrada Casazza, 98124 Messina, Italy.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'De Cola', 'Affiliation': 'Rocco Salvatore Calabrò, IRCCS Centro Neurolesi ""Bonino-Pulejo"", S.S. 113, Contrada Casazza, 98124 Messina, Italy.'}, {'ForeName': 'Rocco Salvatore', 'Initials': 'RS', 'LastName': 'Calabrò', 'Affiliation': 'Rocco Salvatore Calabrò, IRCCS Centro Neurolesi ""Bonino-Pulejo"", S.S. 113, Contrada Casazza, 98124 Messina, Italy. Electronic address: salbro77@tiscali.it.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2021.03.015'] 3050,33823419,Loss of benefits after cessation of exercise interventions in nursing home residents: randomized controlled trial follow-up.,"Exercise interventions improve physical fitness, cognitive and affective function, and quality of life among nursing home residents. However, little is known regarding the consequences of cessation of activity, or detraining. We analyzed physical fitness, physical activity level, cognitive function, quality of life, and loneliness during a 6-month observational follow-up after a 6-month randomized controlled trial in which nursing home residents performed either routine activities (control group) or group-based exercise (intervention group). The intervention group showed an important decline in most physical fitness and cognitive function parameters after a 6-month detraining period. These results highlight the importance of recreation as part of residents' care needs, and exercise should therefore be implemented continuously.",2021,The intervention group showed an important decline in most physical fitness and cognitive function parameters after a 6-month detraining period.,['nursing home residents'],"['exercise interventions', 'Exercise interventions', 'routine activities (control group) or group-based exercise (intervention group']","['physical fitness, physical activity level, cognitive function, quality of life, and loneliness', 'physical fitness and cognitive function parameters', 'physical fitness, cognitive and affective function, and quality of life']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.0114265,The intervention group showed an important decline in most physical fitness and cognitive function parameters after a 6-month detraining period.,"[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Rodriguez-Larrad', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Barrio Sarriena s/n, E-48940 Leioa (Bizkaia), Spain.'}, {'ForeName': 'Haritz', 'Initials': 'H', 'LastName': 'Arrieta', 'Affiliation': 'Department of Nursing II, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Begiristain Doktorea Pasealekua 105, E-20014 Donostia (Gipuzkoa), Spain. Electronic address: haritz.arrieta@ehu.eus.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Rezola-Pardo', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Barrio Sarriena s/n, E-48940 Leioa (Bizkaia), Spain.'}, {'ForeName': 'Izaro', 'Initials': 'I', 'LastName': 'Esain', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Barrio Sarriena s/n, E-48940 Leioa (Bizkaia), Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Mendia-Oria', 'Affiliation': 'Lamourous (Matia Fundazioa), Joseba Zubimendi 1, E-20015 Donostia (Gipuzkoa), Spain.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Irazusta', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Barrio Sarriena s/n, E-48940 Leioa (Bizkaia), Spain.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2021.03.009'] 3051,33823379,Efficacy of scenario simulation-based education in relieving parental anxiety about fever in children.,"PURPOSE This study was designed to evaluate the short- and long-term effects of a scenario simulation-based education intervention on parental anxiety about fever in their children. DESIGN AND METHODS This experimental research was conducted using a two-group pretest-posttest design. One hundred and sixty parents of 3-month to 5-year-old children enrolled in preschools and kindergartens with childcare services were recruited as participants using cluster random sampling. The participants were divided randomly into an experimental group (80) and a control group (80). The former participated in a scenario simulation-based education intervention and received a fever education booklet. The latter received the booklet only. Data were collected using the Children's Fever Anxiety Inventory at three time points: before the intervention (pretest, T1) and at six-month (T2) and 12-month (T3) posttests. RESULTS Significant intergroup differences in fever anxiety were found at both T2 and T3 (p < .001). For both groups, the scores at T2 and T3 were significantly lower than at T1 (p < .001) and the difference between T2 and T3 did not attain statistical significance (p > .05). Although both groups experienced reduced fever anxiety over time, this reduction was significantly greater in the experimental group than in the control group (p < .001). CONCLUSION Simulation-based education may be used in conjunction with the traditional fever education booklet to further reduce parent fever anxiety over time. PRACTICE IMPLICATIONS This simulation-based education approach significantly and positively impacts parental anxiety about fever in their children. Furthermore, the approach may be generalizable to other childhood healthcare settings.",2021,"RESULTS Significant intergroup differences in fever anxiety were found at both T2 and T3 (p < .001).","['parental anxiety about fever in children', 'parental anxiety about fever in their children', 'One hundred and sixty parents of 3-month to 5-year-old children enrolled in preschools and kindergartens with childcare services']","['scenario simulation-based education', 'scenario simulation-based education intervention', 'scenario simulation-based education intervention and received a fever education booklet']","['fever anxiety', ""Children's Fever Anxiety Inventory""]","[{'cui': 'C0577602', 'cui_str': 'Parental anxiety'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",160.0,0.0167805,"RESULTS Significant intergroup differences in fever anxiety were found at both T2 and T3 (p < .001).","[{'ForeName': 'Li Chuan', 'Initials': 'LC', 'LastName': 'Chang', 'Affiliation': 'Department of Nursing, National Tainan Junior College of Nursing, Tainan, Taiwan. Electronic address: fabchuan@ntin.edu.tw.'}, {'ForeName': 'Mei Chih', 'Initials': 'MC', 'LastName': 'Huang', 'Affiliation': 'Department of Nursing, National Tainan Junior College of Nursing, Tainan, Taiwan; Department of Nursing, College of Medicine, National Cheng Kung University, Tainan, Taiwan. Electronic address: meay@mail.ncku.edu.tw.'}]",Journal of pediatric nursing,['10.1016/j.pedn.2021.03.024'] 3052,33829706,[A Preliminary Study of Applying Geometric Deep Learning in Brain Morphometry for Diagnosis of Alzheimer's Disease].,"Objective A predictive model of Alzheimer's disease (AD) was established based on brain surface meshes and geometric deep learning, and its performance was evaluated. Methods Seventy-six clinically diagnosed AD patients and 83 healthy older adults were enrolled and randomly assigned to the training set and the test set according to a 4-to-1 ratio. Brain surface mesh was constructed from 3-D T1-weighted high-resolution structural MR volumes of each participant. After applying a series of simplification to the surface meshes, the training set was fed into the geometric deep neural network for training. The performance of the prediction model was evaluated with the test set, and the evaluation metrics included accuracy, sensitivity and specificity. Results The prediction model trained on the right brain surface meshes with 6 000 faces achieved the best performance, with accuracy reaching 93.8%, sensitivity, 91.7%, and specificity, 94.1%. The evolution of the brain surface meshes during convolution and pooling revealed that AD patients had diffuse brain tissue loss compared with healthy older adults. Conclusion Morphological brain analysis based on mesh data and geometric deep learning has great potential in the differential diagnosis of AD.",2021,"The evolution of the brain surface meshes during convolution and pooling revealed that AD patients had diffuse brain tissue loss compared with healthy older adults. ","['Methods\n\n\nSeventy-six clinically diagnosed AD patients and 83 healthy older adults', ""Alzheimer's disease (AD"", 'healthy older adults']",['Geometric Deep Learning'],"['diffuse brain tissue loss', 'accuracy, sensitivity and specificity']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}]","[{'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0440746', 'cui_str': 'Brain tissue'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}]",76.0,0.152645,"The evolution of the brain surface meshes during convolution and pooling revealed that AD patients had diffuse brain tissue loss compared with healthy older adults. ","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xie', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Huai-Qiang', 'Initials': 'HQ', 'LastName': 'Sun', 'Affiliation': 'Huaxi MR Research Center, Department of Radiology, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Jia-Wei', 'Initials': 'JW', 'LastName': 'Chen', 'Affiliation': 'Department of Ultrasound Medicine, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Zhen-Lin', 'Initials': 'ZL', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Chun-Chao', 'Initials': 'CC', 'LastName': 'Xia', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu 610041, China.'}]",Sichuan da xue xue bao. Yi xue ban = Journal of Sichuan University. Medical science edition,['10.12182/20210360103'] 3053,33829640,"Improving dental-oral health learning in students using a mobile application (""My tooth""): A controlled before and after study.","OBJECTIVES Tooth decay is one of the most common problems amongst students. Despite considerable educational interventions, it is still very prevalent. The aim of this study was to compare the effect of a dental-oral health mobile educational application with the common dental-oral health education amongst elementary school students. METHODS This interventional study was carried out on 158 girl students in the age range of 10-12 years in Mobarakeh City, Iran. The participants were categorized into the intervention and control groups and investigated in the academic year of 2018-2019. The research tool was a researcher-made questionnaire with confirmed validity and reliability. Initially, all students completed the questionnaires. Later, the intervention group members were trained using dental-oral health mobile educational application and control group received the common dental-oral health educations in lectures and demonstrations. Two months after the last intervention, the same questionnaire was completed and data were analysed by SPSS software. RESULTS Before the intervention, the mean score of behaviour was 13.69 ± 3.89 and 13.93 ± 3.02 (of 21) for the intervention and control groups. At this phase, the difference between the two groups was not significant in the studied dimensions (p > 0.05). After the intervention, mean scores of the intervention group increased significantly with regard to all variables (p < 0.05). CONCLUSIONS Findings of this study confirmed the positive effect of learning through mobile applications on increasing the students' knowledge, attitude and performance regarding dental-oral health education.",2021,"After the intervention, mean scores of the intervention group increased significantly with regard to all variables (P <0.05). ","['elementary school students', '158 girl students in the age range of 10-12 years in Mobarakeh City, Iran', 'students using a mobile application (""Mytooth']","['dental-oral health mobile educational application and control group received the common dental-oral health educations in lectures and demonstrations', 'dental-oral health mobile educational application']","['mean scores', 'mean score of behavior']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0018703', 'cui_str': 'Oral health education'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0183708,"After the intervention, mean scores of the intervention group increased significantly with regard to all variables (P <0.05). ","[{'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Rahaei', 'Affiliation': 'Department of Health Education and Promotion, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Moradian', 'Affiliation': 'Department of Health Education and Promotion, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Falahati-Marvast', 'Affiliation': 'Department of Health Technology Assessment, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}]",International journal of dental hygiene,['10.1111/idh.12504'] 3054,33828514,"A Self-Compassion and Mindfulness-Based Cognitive Mobile Intervention (Serene) for Depression, Anxiety, and Stress: Promoting Adaptive Emotional Regulation and Wisdom.","Introduction: Many individuals and families are currently experiencing a high level of COVID-19-related stress and are struggling to find helpful coping mechanisms. Mindfulness-based interventions are becoming an increasingly popular treatment for individuals experiencing depression and chronic levels of stress. The app (Serene) draws from scholarly evidence on the efficacy of mindfulness meditations and builds on the pre-existing apps by incorporating techniques that are used in some therapies such as cognitive behavioral therapy and mindfulness-based cognitive therapy. Methods: Participants were randomly assigned to a 4-week mindfulness and self-compassion-based cognitive smartphone intervention (Serene) or a wait-list control group. They were instructed to engage in self-compassion and mindfulness practices and a cognitive restructuring task. They also completed measures that evaluated their levels of depression, stress, anxiety, self-compassion, wisdom, psychological well-being, and subjective well-being. The intervention group was also instructed to track their weekly engagement with the app. Standardized effect sizes for between-group differences were calculated using Cohen's d for complete case analyses. Results: Complete case analyses from baseline to the end of this randomized controlled trial demonstrated significant moderate between-group differences for depressive symptoms ( d = -0.43) and decisiveness ( d = 0.34). Moderate between-group differences were also found for self-compassion ( d = 0.6) such that significant improvements in self-kindness, common humanity, mindfulness and decreases in self-judgement, isolation, and overidentification were observed. A small between-group difference was found for emotional regulation ( d = 0.28). Moreover, a significant moderate within-group decrease in stress ( d = -0.52) and anxiety symptoms ( d = -0.47) was also observed in the intervention group. Conclusions: Serene is an effective intervention that promotes increased levels of self-compassion and emotional regulation. Engaging with Serene may help reduce depressive symptoms through mindfulness, self-compassion, and cognitive restructuring which help reduce overidentification with one's negative emotions. As individuals rebalance their thinking through cognitive restructuring, they can identify the varying stressors in their life, develop action plans and engage in adaptive coping strategies to address them. Serene may promote greater self-understanding which may provide one with a more balanced perspective on their current upsetting situations to positively transform their challenges during the pandemic.",2021,Complete case analyses from baseline to the end of this randomized controlled trial demonstrated significant moderate between-group differences for depressive symptoms ( d = -0.43) and decisiveness ( d = 0.34).,[],"['Self-Compassion and Mindfulness-Based Cognitive Mobile Intervention (Serene', '4-week mindfulness and self-compassion-based cognitive smartphone intervention (Serene) or a wait-list control group']","['self-kindness, common humanity, mindfulness and decreases in self-judgement, isolation, and overidentification', 'levels of self-compassion and emotional regulation', 'anxiety symptoms', 'depressive symptoms', 'self-compassion', 'levels of depression, stress, anxiety, self-compassion, wisdom, psychological well-being, and subjective well-being', 'stress', 'emotional regulation']",[],"[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0020157', 'cui_str': 'Humanities'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0175918,Complete case analyses from baseline to the end of this randomized controlled trial demonstrated significant moderate between-group differences for depressive symptoms ( d = -0.43) and decisiveness ( d = 0.34).,"[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Al-Refae', 'Affiliation': 'The Wisdom and Identity Lab, Department of Applied Psychology and Human Development, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Al-Refae', 'Affiliation': 'The Wisdom and Identity Lab, Department of Applied Psychology and Human Development, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Munroe', 'Affiliation': 'The Wisdom and Identity Lab, Department of Applied Psychology and Human Development, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Nicole A', 'Initials': 'NA', 'LastName': 'Sardella', 'Affiliation': 'The Wisdom and Identity Lab, Department of Applied Psychology and Human Development, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Ferrari', 'Affiliation': 'The Wisdom and Identity Lab, Department of Applied Psychology and Human Development, University of Toronto, Toronto, ON, Canada.'}]",Frontiers in psychology,['10.3389/fpsyg.2021.648087'] 3055,33828410,Can a Multilevel STI/HIV Prevention Strategy for High Risk African American Adolescents Improve Life Satisfaction?,"Addressing adolescent sexual risk behaviors in the STI/HIV prevention literature is well documented; however, impacts from interventions on life satisfaction are relatively unexplored. This study examined data (n = 1658) from a randomized, multi-site, multi-level STI/HIV prevention intervention trial (Project iMPAACS) to determine whether increased protective and reduced sexual risk-taking behaviors associated with STI/HIV would also improve self-reported life satisfaction. Taking into account the nested study design and controlling for confounders, a mixed model ANOVA was performed where Total mean life satisfaction scores were analyzed at baseline and 3, 6, 12, and 18 months post-recruitment. Significance levels of 0.05 were used to determine significance and η 2 was used to assess effect size. We hypothesized that as intervention participants engaged in the intentional activity associated with increasing protective behaviors and reducing sexual risk-taking behaviors associated with STI/HIV, life satisfaction reports would also improve over the course of the intervention. A significant main effect for sex was detected ( F = 5.19, p = .02, η 2 = .03), along with three interactions: between experimental condition and media intervention ( F = 7.96, p = .005, η 2 = .04); experimental condition, sex, and media intervention ( F = 6.51, p = .01, η 2 = .04); and experimental condition, sex, assessment point, and media intervention ( F = 3.23, p = .01, η 2 = .02). With the exception of the control condition, female life satisfaction reports improved from baseline assessments to 18-months post-recruitment, whereas male reports decreased. Project iMPPACS was not designed with the intent on improving participants' life satisfaction. However, study results suggest incorporating strategies to address subjective well-being into future adolescent STI/HIV risk-reduction interventions is beneficial for females and additional research is necessary for males.",2020,"With the exception of the control condition, female life satisfaction reports improved from baseline assessments to 18-months post-recruitment, whereas male reports decreased.",['High Risk African American Adolescents'],[],"['sexual risk-taking behaviors', 'Total mean life satisfaction scores']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",[],"[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0035651', 'cui_str': 'Risk-Taking'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",1658.0,0.0539373,"With the exception of the control condition, female life satisfaction reports improved from baseline assessments to 18-months post-recruitment, whereas male reports decreased.","[{'ForeName': 'Keith J', 'Initials': 'KJ', 'LastName': 'Zullig', 'Affiliation': 'Department of Social and Behavioral Sciences, School of Public Health, West Virginia University, Morgantown, WV 9190-26506, USA.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Valois', 'Affiliation': 'Department of Health Promotion, Education and Behavior, Department of Family and Preventive Medicine, Schools of Public Health and Medicine, University of South Carolina, Columbia, SC 29208, USA.'}, {'ForeName': 'Gerald R', 'Initials': 'GR', 'LastName': 'Hobbs', 'Affiliation': 'Department of Statistics, West Virginia University, Morgantown, WV 26506, USA.'}, {'ForeName': 'Jelani C', 'Initials': 'JC', 'LastName': 'Kerr', 'Affiliation': 'Department of Health Promotion and Behavioral Sciences, School of Public Health and Information Sciences, University of Louisville, Louisville, KY 40202, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Romer', 'Affiliation': 'Public Policy Center, Annenberg School for Communication, Adolescent Communication Institute, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Carey', 'Affiliation': 'The Centers for Behavioral and Preventive Medicine, The Miriam Hospital and Brown University, Providence, RI, USA.'}, {'ForeName': 'Larry K', 'Initials': 'LK', 'LastName': 'Brown', 'Affiliation': 'The Centers for Behavioral and Preventive Medicine, The Miriam Hospital and Brown University, Providence, RI, USA.'}, {'ForeName': 'Ralph J', 'Initials': 'RJ', 'LastName': 'DiClemente', 'Affiliation': 'Department of Social and Behavioral Sciences, College of Global Public Health, New York University, New York, NY 10012, USA.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Vanable', 'Affiliation': 'Department of Psychology, Center for Health and Behavior, Syracuse University, Syracuse, NY, USA.'}]",Journal of happiness studies,['10.1007/s10902-019-00084-z'] 3056,33827787,"Efficacy and safety of brodalumab, an anti-IL17RA monoclonal antibody, in patients with axial spondyloarthritis: 16-week results from a randomised, placebo-controlled, phase 3 trial.","OBJECTIVE To investigate the efficacy and safety of brodalumab, a fully human anti-interleukin-17 receptor A monoclonal antibody, in patients with axial spondyloarthritis (axSpA). METHODS In a multicentre, placebo-controlled phase 3 study (NCT02985983) conducted at 48 sites across Japan, Korea and Taiwan, patients with axSpA were randomised 1:1 to receive subcutaneous brodalumab 210 mg (n=80) or placebo (n=79) at baseline, weeks 1 and 2 and every 2 weeks thereafter, during the 16-week double-blind period. The primary endpoint was the proportion of patients with Assessment of SpondyloArthritis International Society (ASAS) 40 response at week 16. Secondary endpoints included the proportion of patients with ASAS 20 response and change in Ankylosing Spondylitis Disease Activity Score using C-reactive protein (ASDAS-CRP) at week 16 and safety. RESULTS ASAS 40 response rate (n/N; 95% CI) was 43.8% (35/80; 32.7, 55.3) with brodalumab vs 24.1% (19/79; 15.1, 35.0) with placebo (rate difference, 19.7% (5.3, 34.1); p=0.018 by stratified Cochran-Mantel-Haenszel test). ASAS 20 response rate (n/N; 95% CI) was 67.5% (54/80; 56.1, 77.6) vs 41.8% (33/79; 30.8, 53.4) and least squares mean change (95% CI) from baseline (brodalumab, 2.660; placebo, 2.716) in ASDAS-CRP was -1.127 (-1.322, -0.931) with brodalumab vs -0.672 (-0.872, -0.473) with placebo at week 16. Treatment-emergent adverse events were reported in 44 (55%) and 45 (57%) patients in the brodalumab and placebo groups, respectively. CONCLUSION Brodalumab demonstrated a significant improvement at week 16 in patients with active axSpA. Safety of brodalumab was consistent with that reported in previous global/Japanese psoriasis studies.",2021,"Treatment-emergent adverse events were reported in 44 (55%) and 45 (57%) patients in the brodalumab and placebo groups, respectively. ","['48 sites across Japan, Korea and Taiwan, patients with axSpA', 'patients with axial spondyloarthritis', 'patients with axial spondyloarthritis (axSpA']","['brodalumab', 'placebo', 'subcutaneous brodalumab 210 mg (n=80) or placebo']","['ASAS 20 response rate', 'ASAS 40 response rate', 'Treatment-emergent adverse events', 'proportion of patients with Assessment of SpondyloArthritis International Society (ASAS) 40 response', 'proportion of patients with ASAS 20 response and change in Ankylosing Spondylitis Disease Activity Score using C-reactive protein (ASDAS-CRP', 'Efficacy and safety']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis'}]","[{'cui': 'C3491331', 'cui_str': 'brodalumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4319559', 'cui_str': '210'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0949690', 'cui_str': 'Arthritis of spine'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C2711259', 'cui_str': 'Rheumatoid arthritis disease activity score using C-reactive protein'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.694723,"Treatment-emergent adverse events were reported in 44 (55%) and 45 (57%) patients in the brodalumab and placebo groups, respectively. ","[{'ForeName': 'James Cheng-Chung', 'Initials': 'JC', 'LastName': 'Wei', 'Affiliation': 'Department of Allergy, Immunology & Rheumatology, Chung Shan Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Tae-Hwan', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, The Republic of Korea.'}, {'ForeName': 'Mitsumasa', 'Initials': 'M', 'LastName': 'Kishimoto', 'Affiliation': 'Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Ogusu', 'Affiliation': 'Clinical Development Center, R&D Division, Kyowa Kirin Co, Ltd, Tokyo, Japan.'}, {'ForeName': 'Haeyoun', 'Initials': 'H', 'LastName': 'Jeong', 'Affiliation': 'Development Department, Kyowa Kirin Korea Co., Ltd, Seoul, The Republic of Korea.'}, {'ForeName': 'Shigeto', 'Initials': 'S', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Internal Medicine and Rheumatology, Juntendo University Koshigaya Hospital, Saitama, Japan shigeto@juntendo.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-219406'] 3057,33827659,Protocol for a randomized controlled trial of pre-pregnancy lifestyle intervention to reduce recurrence of gestational diabetes: Gestational Diabetes Prevention/Prevención de la Diabetes Gestacional.,"BACKGROUND Gestational diabetes mellitus (GDM) is associated with several maternal complications in pregnancy, including preeclampsia, preterm labor, need for induction of labor, and cesarean delivery as well as increased long-term risks of type 2 diabetes, metabolic syndrome, and cardiovascular disease. Intrauterine exposure to GDM raises the risk for complications in offspring as well, including stillbirth, macrosomia, and birth trauma, and long-term risk of metabolic disease. One of the strongest risk factors for GDM is the occurrence of GDM in a prior pregnancy. Preliminary data from epidemiologic and bariatric surgery studies suggest that reducing body weight before pregnancy can prevent the development of GDM, but no adequately powered trial has tested the effects of a maternal lifestyle intervention before pregnancy to reduce body weight and prevent GDM recurrence. METHODS The principal aim of the Gestational Diabetes Prevention/Prevención de la Diabetes Gestacional is to determine whether a lifestyle intervention to reduce body weight before pregnancy can reduce GDM recurrence. This two-site trial targets recruitment of 252 women with overweight and obesity who have previous histories of GDM and who plan to have another pregnancy in the next 1-3 years. Women are randomized within site to a comprehensive pre-pregnancy lifestyle intervention to promote weight loss with ongoing treatment until conception or an educational control group. Participants are assessed preconceptionally (at study entry, after 4 months, and at brief quarterly visits until conception), during pregnancy (at 26 weeks' gestation), and at 6 weeks postpartum. The primary outcome is GDM recurrence, and secondary outcomes include fasting glucose, biomarkers of cardiometabolic disease, prenatal and perinatal complications, and changes over time in weight, diet, physical activity, and psychosocial measures. DISCUSSION The Gestational Diabetes Prevention /Prevención de la Diabetes Gestacional is the first randomized controlled trial to evaluate the effects of a lifestyle intervention delivered before pregnancy to prevent GDM recurrence. If found effective, the proposed lifestyle intervention could lay the groundwork for shifting current treatment practices towards the interconception period and provide evidence-based preconception counseling to optimize reproductive outcomes and prevent GDM and associated health risks. TRIAL REGISTRATION ClinicalTrials.gov NCT02763150 . Registered on May 5, 2016.",2021,de la Diabetes Gestacional is the first randomized controlled trial to evaluate the effects of a lifestyle intervention delivered before pregnancy to prevent GDM recurrence.,"['gestational diabetes: Gestational Diabetes Prevention/Prevención de la Diabetes Gestacional', 'Gestational diabetes mellitus (GDM', '252 women with overweight and obesity who have previous histories of GDM and who plan to have another pregnancy in the next 1-3\u2009years', 'Gestational Diabetes Prevention /Prevención']","['comprehensive pre-pregnancy lifestyle intervention', 'lifestyle intervention', 'pre-pregnancy lifestyle intervention', 'GDM']","['GDM recurrence, and secondary outcomes include fasting glucose, biomarkers of cardiometabolic disease, prenatal and perinatal complications, and changes over time in weight, diet, physical activity, and psychosocial measures', 'GDM recurrence']","[{'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C2183115', 'cui_str': 'History of gestational diabetes mellitus'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}]","[{'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",252.0,0.077826,de la Diabetes Gestacional is the first randomized controlled trial to evaluate the effects of a lifestyle intervention delivered before pregnancy to prevent GDM recurrence.,"[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Phelan', 'Affiliation': 'Department of Kinesiology & Public Health, Center for Health Research, California Polytechnic State University, San Luis Obispo, CA, USA. sphelan@calpoly.edu.'}, {'ForeName': 'Elissa', 'Initials': 'E', 'LastName': 'Jelalian', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Coustan', 'Affiliation': 'Department of Obstetrics and Gynecology, Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Aaron B', 'Initials': 'AB', 'LastName': 'Caughey', 'Affiliation': 'Department of Obstetrics and Gynecology, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Castorino', 'Affiliation': 'Sansum Diabetes Research Institute, Santa Barbara, CA, USA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Hagobian', 'Affiliation': 'Department of Kinesiology & Public Health, Center for Health Research, California Polytechnic State University, San Luis Obispo, CA, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Muñoz-Christian', 'Affiliation': 'Department of World Languages and Cultures, California Polytechnic State University, San Luis Obispo, CA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Schaffner', 'Affiliation': 'Statistics Department, California Polytechnic State University, San Luis Obispo, CA, USA.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Shields', 'Affiliation': 'Dignity Health, Marian Regional Medical Center, Santa Maria, CA, USA.'}, {'ForeName': 'Casey', 'Initials': 'C', 'LastName': 'Heaney', 'Affiliation': 'Department of Kinesiology & Public Health, Center for Health Research, California Polytechnic State University, San Luis Obispo, CA, USA.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'McHugh', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital, Providence, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital, Providence, USA.'}]",Trials,['10.1186/s13063-021-05204-w'] 3058,33827653,The use of virtual reality to reduce stress among night-shift anesthesiologists: study protocol for a crossover trial.,"BACKGROUND Because of the lack of anesthesia workforce, anesthesiologists are forced to work overtime and more night shifts, which can disturb their biological rhythm and cause severe stress and depression, potentially leading to negative and even devastating outcomes for both themselves and patients. Virtual reality (VR), a new method to reduce stress and pain for patients, has been widely used in biomedical fields. The purpose of this study is to evaluate the potential effectiveness of VR technology in reducing stress among night-shift anesthesiologists. METHODS In this randomized controlled, crossover, single-center clinical trial, a total of 30 anesthesiologists will be enrolled and randomized in a 1:1 allocation to either the VR immersion group (intervention group) or the routine night-shift group (control group) with a washout of 1 week. Anesthesiologists in the intervention group will undergo VR immersion twice, while anesthesiologists in the control group will not watch VR videos during the night shift. The primary outcome will be the difference in the NASA Task Load Index (NASA-TLX) score between the two groups. Secondary outcomes will include the Chinese Perceived Stress Scale (CPSS), perceived stress scores (visual analogue scale (VAS)), and Multidimensional Fatigue Inventory (MFI-20) scores; levels of satisfaction among the participants; incidence of arrhythmia; and incidence of chest tightness, headache, and palpitations. DISCUSSION It is unknown whether the use of VR technology during the night shift can reduce stress among anesthesiologists. With the widespread use of VR technology, a positive result in this trial could spur hospitals to apply VR technology to reduce stress among night-shift doctors in every department and provide a relatively relaxed working environment. TRIAL REGISTRATION Chinese Clinical Trial Registry ChiCTR2000031025 . Registered on 21 March 2020.",2021,The primary outcome will be the difference in the NASA Task Load Index (NASA-TLX) score between the two groups.,['30 anesthesiologists'],"['VR immersion group (intervention group) or the routine night-shift group (control group) with a washout of 1\u2009week', 'VR technology', 'Virtual reality (VR']","['Chinese Perceived Stress Scale (CPSS), perceived stress scores (visual analogue scale (VAS)), and Multidimensional Fatigue Inventory (MFI-20) scores; levels of satisfaction among the participants; incidence of arrhythmia; and incidence of chest tightness, headache, and palpitations', 'NASA Task Load Index (NASA-TLX) score']","[{'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0232292', 'cui_str': 'Tight chest'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0030252', 'cui_str': 'Palpitations'}, {'cui': 'C0242776', 'cui_str': 'National Aeronautics and Space Administration'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",30.0,0.0902142,The primary outcome will be the difference in the NASA Task Load Index (NASA-TLX) score between the two groups.,"[{'ForeName': 'Chaojin', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, The Third Affiliated Hospital of Sun Yat-sen University, No. 600 Tianhe Road, Guangzhou, 510630, Guangdong Province, China.'}, {'ForeName': 'Liubing', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, The Third Affiliated Hospital of Sun Yat-sen University, No. 600 Tianhe Road, Guangzhou, 510630, Guangdong Province, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Shen', 'Affiliation': 'Department of Anesthesiology, The Third Affiliated Hospital of Sun Yat-sen University, No. 600 Tianhe Road, Guangzhou, 510630, Guangdong Province, China.'}, {'ForeName': 'Chenfang', 'Initials': 'C', 'LastName': 'Luo', 'Affiliation': 'Department of Anesthesiology, The Third Affiliated Hospital of Sun Yat-sen University, No. 600 Tianhe Road, Guangzhou, 510630, Guangdong Province, China.'}, {'ForeName': 'Ren', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The Third Affiliated Hospital of Sun Yat-sen University, No. 600 Tianhe Road, Guangzhou, 510630, Guangdong Province, China.'}, {'ForeName': 'Hongyi', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': 'Department of Anesthesiology, The Third Affiliated Hospital of Sun Yat-sen University, No. 600 Tianhe Road, Guangzhou, 510630, Guangdong Province, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Cell-gene Therapy Translational Medicine Research Center, The Third Affiliated Hospital of Sun Yat-sen University, No. 600 Tianhe Road, Guangzhou, 510630, Guangdong Province, China. keekee77@126.com.'}, {'ForeName': 'Ziqing', 'Initials': 'Z', 'LastName': 'Hei', 'Affiliation': 'Department of Anesthesiology, The Third Affiliated Hospital of Sun Yat-sen University, No. 600 Tianhe Road, Guangzhou, 510630, Guangdong Province, China. heiziqing@sina.com.'}]",Trials,['10.1186/s13063-021-05222-8'] 3059,33827652,Update to the effectiveness and cost-effectiveness of a mindfulness training programme in schools compared with normal school provision (MYRIAD): study protocol for a randomised controlled trial.,"BACKGROUND MYRIAD (My Resilience in Adolescence) is a superiority, parallel group, cluster randomised controlled trial designed to examine the effectiveness and cost-effectiveness of a mindfulness training (MT) programme, compared with normal social and emotional learning (SEL) school provision to enhance mental health, social-emotional-behavioural functioning and well-being in adolescence. The original trial protocol was published in Trials (accessible at https://doi.org/10.1186/s13063-017-1917-4 ). This included recruitment in two cohorts, enabling the learning from the smaller first cohort to be incorporated in the second cohort. Here we describe final amendments to the study protocol and discuss their underlying rationale. METHODS Four major changes were introduced into the study protocol: (1) there were changes in eligibility criteria, including a clearer operational definition to assess the degree of SEL implementation in schools, and also new criteria to avoid experimental contamination; (2) the number of schools and pupils that had to be recruited was increased based on what we learned in the first cohort; (3) some changes were made to the secondary outcome measures to improve their validity and ability to measure constructs of interest and to reduce the burden on school staff; and (4) the current Coronavirus Disease 2019 (SARS-CoV-2 or COVID-19) pandemic both influences and makes it difficult to interpret the 2-year follow-up primary endpoint results, so we changed our primary endpoint to 1-year follow-up. DISCUSSION These changes to the study protocol were approved by the Trial Management Group, Trial Steering Committee and Data and Ethics Monitoring Committees and improved the enrolment of participants and quality of measures. Furthermore, the change in the primary endpoint will give a more reliable answer to our primary question because it was collected prior to the COVID-19 pandemic in both cohort 1 and cohort 2. Nevertheless, the longer 2-year follow-up data will still be acquired, although this time-point will be now framed as a second major investigation to answer some new important questions presented by the combination of the pandemic and our study design. TRIAL REGISTRATION International Standard Randomised Controlled Trials ISRCTN86619085 . Registered on 3 June 2016.",2021,"These changes to the study protocol were approved by the Trial Management Group, Trial Steering Committee and Data and Ethics Monitoring Committees and improved the enrolment of participants and quality of measures.","['Four major changes were introduced into the study protocol: (1) there were changes in eligibility criteria, including a clearer operational definition to assess the degree of SEL implementation in schools, and also new criteria to avoid experimental contamination; (2) the number of schools and pupils that had to be recruited', 'schools compared with normal school provision (MYRIAD']","['mindfulness training (MT) programme', 'mindfulness training programme', 'normal social and emotional learning (SEL) school provision']","['mental health, social-emotional-behavioural functioning', 'effectiveness and cost-effectiveness']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1292748', 'cui_str': 'Introduces'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0582589', 'cui_str': 'Emotional learning'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0582589', 'cui_str': 'Emotional learning'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.359978,"These changes to the study protocol were approved by the Trial Management Group, Trial Steering Committee and Data and Ethics Monitoring Committees and improved the enrolment of participants and quality of measures.","[{'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Montero-Marin', 'Affiliation': 'Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Nuthall', 'Affiliation': 'Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Byford', 'Affiliation': 'Kings Health Economics, Kings College London, London, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Crane', 'Affiliation': 'Oxford Institute of Clinical Psychology Training, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Dalgleish', 'Affiliation': 'MRC Cognition and Brain Sciences Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Tamsin', 'Initials': 'T', 'LastName': 'Ford', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Poushali', 'Initials': 'P', 'LastName': 'Ganguli', 'Affiliation': 'Kings Health Economics, Kings College London, London, UK.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Greenberg', 'Affiliation': 'Prevention Research Center, Pennsylvania State University, State College, PA, USA.'}, {'ForeName': 'Obioha C', 'Initials': 'OC', 'LastName': 'Ukoumunne', 'Affiliation': 'NIHR ARC South West Peninsula (PenARC), University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Russell M', 'Initials': 'RM', 'LastName': 'Viner', 'Affiliation': 'UCL Institute of Child Health, London, UK.'}, {'ForeName': 'J Mark G', 'Initials': 'JMG', 'LastName': 'Williams', 'Affiliation': 'Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'Kuyken', 'Affiliation': 'Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, UK. willem.kuyken@psych.ox.ac.uk.'}]",Trials,['10.1186/s13063-021-05213-9'] 3060,33831710,Influence of suppression and reappraisal on eating-related symptoms and ruminative thinking in anorexia nervosa and bulimia nervosa.,"The goal of the present study was to investigate the influence of expressive suppression and cognitive reappraisal on eating-related symptomatology in anorexia nervosa (AN) and bulimia nervosa (BN). Secondly, on the background of theoretical models proposing a reciprocal relationship between suppression and rumination, we sought to understand whether inhibition of emotional expression also affects ruminative thinking in eating disorders. Women with AN (n = 39), BN (n = 37) and a control group (CG, n = 41) were randomly assigned to either engage in suppression or reappraisal during a sadness-eliciting film clip. Levels of drive to eat, anticipated loss of control over eating and ruminative thoughts were rated before and after the induction of emotion regulation. Induced expressive suppression led to a decrease of reported drive to eat in AN and an increase of anticipated loss of control over eating in BN. All groups responded to suppression with greater rumination, whereas no significant changes were found for reappraisal. Mediation analyses on trait questionnaires pointed to rumination as a partial mediator of the correlation between suppression and eating disorder pathology. Results are discussed in line with recent empirical research and current emotion regulation theories.",2021,"All groups responded to suppression with greater rumination, whereas no significant changes were found for reappraisal.","['anorexia nervosa (AN) and bulimia nervosa (BN', 'Women with AN (n\xa0=\xa039), BN (n\xa0=\xa037) and a control group (CG, n\xa0=\xa041', 'anorexia nervosa and bulimia nervosa', 'eating disorders']","['suppression and reappraisal', 'engage in suppression or reappraisal during a sadness-eliciting film clip', 'expressive suppression and cognitive reappraisal']","['Levels of drive to eat, anticipated loss of control over eating and ruminative thoughts']","[{'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C2267227', 'cui_str': 'Bulimia nervosa'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0497397', 'cui_str': 'Anorexia and bulimia syndrome'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C3536794', 'cui_str': 'Unhappiness'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0175722', 'cui_str': 'Clip'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}]",41.0,0.0253925,"All groups responded to suppression with greater rumination, whereas no significant changes were found for reappraisal.","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Naumann', 'Affiliation': 'University of Tuebingen, Department of Clinical Psychology and Psychotherapy, Schleichstraße 4, 72076, Tuebingen, Germany. Electronic address: eva.naumann@uni-tuebingen.de.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Svaldi', 'Affiliation': 'University of Tuebingen, Department of Clinical Psychology and Psychotherapy, Schleichstraße 4, 72076, Tuebingen, Germany. Electronic address: jennifer.svaldi@uni-tuebingen.de.'}]",Behaviour research and therapy,['10.1016/j.brat.2021.103851'] 3061,33831698,The effects of dry needling to the thoracolumbar junction multifidi on measures of regional and remote flexibility and pain sensitivity: A randomized controlled trial.,"BACKGROUND Dry needling (DN) has been consistently shown to decrease pain sensitivity and increase flexibility local to the site of treatment, however it is unclear whether these effects are limited to the region of treatment or can be observed remote to the area of treatment. OBJECTIVE To determine the immediate, short-term effects of DN to the thoracolumbar junction on regional and remote flexibility, and to observe if changes in pain sensitivity can occur remote to site of treatment. DESIGN Double-blind randomized clinical trial. METHODS Fifty-four subjects with low back pain and decreased length in at least one hamstring were randomized to receive either DN or sham DN to the T12 and L1 multifidi. Participants underwent regional (fingertip-to-floor) and remote flexibility (passive knee extension, passive straight leg raise) and pressure pain threshold (PPT) testing of the upper and lower extremity before, immediately after and 1 day after treatment. ANCOVAs were used to analyze flexibility data, with the covariate of pre-treatment values. Paired t-tests were used for difference in remote pain sensitivity. RESULTS Statistically larger improvements in regional flexibility, but not remote flexibility, were observed immediately post-treatment in those who received DN than in those receiving sham DN (p = .0495; adjusted difference 1.2, 95% CI 0.002-2.3). Differences between upper and lower extremity PPT were not significant. CONCLUSION DN can potentially have immediate changes in regional flexibility, but effects are not sustained at 24-h follow-up. DN may not affect remote flexibility or segmental pain sensitivity.",2021,"RESULTS Statistically larger improvements in regional flexibility, but not remote flexibility, were observed immediately post-treatment in those who received DN than in those receiving sham DN (p = .0495; adjusted difference 1.2, 95% CI 0.002-2.3).",['Fifty-four subjects with low back pain and decreased length in at least one hamstring'],"['Dry needling (DN', 'DN or sham DN to the T12 and L1 multifidi', 'regional (fingertip-to-floor) and remote flexibility (passive knee extension, passive straight leg raise) and pressure pain threshold']","['pain sensitivity', 'remote flexibility or segmental pain sensitivity', 'remote pain sensitivity', 'extremity PPT', 'regional flexibility', 'remote flexibility', 'regional\xa0and remote flexibility and pain sensitivity']","[{'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}]","[{'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0054967', 'cui_str': 'Lymphocyte antigen CD6'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0729895', 'cui_str': 'Tip of finger'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0422926', 'cui_str': 'Straight leg raise test response'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}]","[{'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0205122', 'cui_str': 'Segmental'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205147', 'cui_str': 'Regional'}]",54.0,0.394241,"RESULTS Statistically larger improvements in regional flexibility, but not remote flexibility, were observed immediately post-treatment in those who received DN than in those receiving sham DN (p = .0495; adjusted difference 1.2, 95% CI 0.002-2.3).","[{'ForeName': 'Nicole G', 'Initials': 'NG', 'LastName': 'Clark', 'Affiliation': 'Stefani Doctor of Physical Therapy Program, University of Saint Mary, 4100 South 4th St, Leavenworth, KS, 66048, USA. Electronic address: nicole.clark@stmary.edu.'}, {'ForeName': 'Cheryl J', 'Initials': 'CJ', 'LastName': 'Hill', 'Affiliation': 'Doctor of Physical Therapy Program, Dr. Pallavi Patel College of Healthcare Sciences, Nova Southeastern University, 3200 South University, Dr. Ft. Lauderdale, FL, 33328, USA. Electronic address: hill@nova.edu.'}, {'ForeName': 'Shane L', 'Initials': 'SL', 'LastName': 'Koppenhaver', 'Affiliation': 'Baylor University, Doctoral Program in Physical Therapy, 1 Bear Place #97264, Waco, TX, 76798, USA. Electronic address: shane_koppenhaver@baylor.edu.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Massie', 'Affiliation': 'Stefani Doctor of Physical Therapy Program, University of Saint Mary, 4100 South 4th St, Leavenworth, KS, 66048, USA. Electronic address: thomas.massie@stmary.edu.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Cleland', 'Affiliation': 'Director of Research and Faculty Development, Doctor of Physical Therapy Program, Department of Public Health and Community Medicine, Tufts University, 136 Harrison Ave, Boston, MA, 02111, USA. Electronic address: joshua.cleland@tufts.edu.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2021.102366'] 3062,33831671,Intravascular ultrasound-based deep learning for plaque characterization in coronary artery disease.,"BACKGROUND AND AIMS Although plaque characterization by intravascular ultrasound (IVUS) is important for risk stratification, frame-by-frame analysis of a whole vascular segment is time-consuming. The aim was to develop IVUS-based algorithms for classifying attenuation and calcified plaques. METHODS IVUS image sets of 598 coronary arteries from 598 patients were randomized into training and test sets with 5:1 ratio. Each IVUS frame at a 0.4-mm interval was circumferentially labeled as one of three classes: attenuated plaque, calcified plaque, or plaque without attenuation or calcification. The model was trained on multi-class classification with 5-fold cross validation. By converting from Cartesian to polar coordinate images, the class corresponding to each array from 0 to 360° was plotted. RESULTS At the angle-level, Dice similarity coefficients for identifying calcification vs. attenuation vs. none by using ensemble model were 0.79, 0.74 and 0.99, respectively. Also, the maximal accuracy was 98% to classify those groups in the test set. At the frame-level, the model identified the presence of attenuation with 80% sensitivity, 96% specificity, and 93% overall accuracy, and the presence of calcium with 86% sensitivity, 97% specificity, and 96% overall accuracy. In the per-vessel analysis, the attenuation and calcification burden index closely correlated with human measurements (r = 0.89 and r = 0.95, respectively), as did the maximal attenuation and calcification burden index over 4 mm (r = 0.82 and r = 0.91, respectively). The inference times were 0.05 s per frame and 7.8 s per vessel. CONCLUSIONS Our deep learning algorithms for plaque characterization may assist clinicians in recognizing high-risk coronary lesions.",2021,"At the frame-level, the model identified the presence of attenuation with 80% sensitivity, 96% specificity, and 93% overall accuracy, and the presence of calcium with 86% sensitivity, 97% specificity, and 96% overall accuracy.","['IVUS image sets of 598 coronary arteries from 598 patients', 'coronary artery disease']","['Intravascular ultrasound-based deep learning', 'intravascular ultrasound (IVUS']","['attenuation and calcification burden index', 'maximal attenuation and calcification burden index', 'maximal accuracy']","[{'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}]","[{'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",598.0,0.117355,"At the frame-level, the model identified the presence of attenuation with 80% sensitivity, 96% specificity, and 93% overall accuracy, and the presence of calcium with 86% sensitivity, 97% specificity, and 96% overall accuracy.","[{'ForeName': 'Hyungjoo', 'Initials': 'H', 'LastName': 'Cho', 'Affiliation': 'Department of Cardiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Soo-Jin', 'Initials': 'SJ', 'LastName': 'Kang', 'Affiliation': 'Department of Cardiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea. Electronic address: sjkang@amc.seoul.kr.'}, {'ForeName': 'Hyun-Seok', 'Initials': 'HS', 'LastName': 'Min', 'Affiliation': 'Department of Cardiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'June-Goo', 'Initials': 'JG', 'LastName': 'Lee', 'Affiliation': 'Biomedical Engineering Research Center, Asan Institute for Life Sciences, Seoul, South Korea.'}, {'ForeName': 'Won-Jang', 'Initials': 'WJ', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiology, CHA Bundang Medical Center, CHA University, Seongnam, South Korea.'}, {'ForeName': 'Se Hun', 'Initials': 'SH', 'LastName': 'Kang', 'Affiliation': 'Department of Cardiology, CHA Bundang Medical Center, CHA University, Seongnam, South Korea.'}, {'ForeName': 'Do-Yoon', 'Initials': 'DY', 'LastName': 'Kang', 'Affiliation': 'Department of Cardiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Pil Hyung', 'Initials': 'PH', 'LastName': 'Lee', 'Affiliation': 'Department of Cardiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Jung-Min', 'Initials': 'JM', 'LastName': 'Ahn', 'Affiliation': 'Department of Cardiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Duk-Woo', 'Initials': 'DW', 'LastName': 'Park', 'Affiliation': 'Department of Cardiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Seung-Whan', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'Department of Cardiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Young-Hak', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Cheol Whan', 'Initials': 'CW', 'LastName': 'Lee', 'Affiliation': 'Department of Cardiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Seong-Wook', 'Initials': 'SW', 'LastName': 'Park', 'Affiliation': 'Department of Cardiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Seung-Jung', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Cardiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2021.03.037'] 3063,33831660,Does complex PTSD predict or moderate treatment outcomes of three variants of exposure therapy?,"BACKGROUND One reason for the inclusion of Complex Posttraumatic Stress Disorder (CPTSD) in the 11th revision of the International Classification of Diseases (ICD-11) was its suspected relevance for treatment indications. We investigated whether CPTSD predicted and moderated treatment outcomes of Prolonged Exposure (PE), intensified PE (iPE) and Skills Training in Affective and Interpersonal Regulation followed by PE (STAIR + PE). We expected that CPTSD would predict worse treatment outcomes across treatments. Secondly, we expected that CPTSD would lead to better treatment effect in STAIR + PE compared to PE and iPE. METHODS We analyzed 149 patients with childhood-abuse related PTSD from a randomized clinical trial. CPTSD diagnosis and symptom severity were measured with the International Trauma Questionnaire. The main outcome was change in clinician-assessed PTSD symptoms. Assessments took place at baseline, week 4, week 8, week 16 (post-treatment) and at a 6-and 12-month follow-up. Analyses were based on an intention-to-treat sample using mixed effect models. RESULTS More than half (54 %) of the patients met criteria for CPTSD at baseline. CPTSD was related to more severe PTSD symptoms and higher comorbidity at baseline. CPTSD neither predicted nor moderated treatment outcome. LIMITATIONS Inclusion was limited to patients with PTSD related to childhood abuse. Replication is needed in different samples. CONCLUSIONS CPTSD is associated with more severe PTSD and with higher comorbidity. CPTSD did not predict treatment outcome and did not indicate differential treatment outcome of STAIR + PE compared to PE and iPE.",2021,CPTSD did not predict treatment outcome and did not indicate differential treatment outcome of STAIR + PE compared to PE and iPE.,"['149 patients with childhood-abuse related PTSD from a randomized clinical trial', 'patients with PTSD related to childhood abuse']","['Prolonged Exposure (PE), intensified PE (iPE) and Skills Training', 'CPTSD']","['severe PTSD symptoms', 'CPTSD diagnosis and symptom severity', 'change in clinician-assessed PTSD symptoms']","[{'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C2733207', 'cui_str': 'Complex posttraumatic stress disorder'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2733207', 'cui_str': 'Complex posttraumatic stress disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",149.0,0.152609,CPTSD did not predict treatment outcome and did not indicate differential treatment outcome of STAIR + PE compared to PE and iPE.,"[{'ForeName': 'Chris M', 'Initials': 'CM', 'LastName': 'Hoeboer', 'Affiliation': 'Leiden University, Department of Clinical Psychology, Leiden, the Netherlands; Parnassiagroep, PsyQ The Hague, the Netherlands. Electronic address: c.m.hoeboer@fsw.leidenuniv.nl.'}, {'ForeName': 'Rianne A', 'Initials': 'RA', 'LastName': 'de Kleine', 'Affiliation': 'Leiden University, Department of Clinical Psychology, Leiden, the Netherlands. Electronic address: r.a.de.kleine@fsw.leidenuniv.nl.'}, {'ForeName': 'Danielle A C', 'Initials': 'DAC', 'LastName': 'Oprel', 'Affiliation': 'Leiden University, Department of Clinical Psychology, Leiden, the Netherlands; Parnassiagroep, PsyQ The Hague, the Netherlands. Electronic address: d.oprel@psyq.nl.'}, {'ForeName': 'Maartje', 'Initials': 'M', 'LastName': 'Schoorl', 'Affiliation': 'Leiden University, Department of Clinical Psychology, Leiden, the Netherlands. Electronic address: m.schoorl@fsw.leidenuniv.nl.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'van der Does', 'Affiliation': 'Leiden University, Department of Clinical Psychology, Leiden, the Netherlands; Parnassiagroep, PsyQ The Hague, the Netherlands; Leiden University Medical Center, Department of Psychiatry, Leiden, the Netherlands. Electronic address: vanderdoes@fsw.leidenuniv.nl.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'van Minnen', 'Affiliation': 'PSYTREC, Bilthoven, the Netherlands; Radboud University, Behavioural Science Institute, Nijmegen, the Netherlands. Electronic address: vanminnen@psytrec.com.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2021.102388'] 3064,33831342,A Smart Mobile Application to Monitor Visual Function in Diabetic Retinopathy and Age-related Macular Degeneration: The CLEAR Study: Mobile Device for Measuring Visual Acuity and Function.,"PURPOSE To determine if a mobile application, Checkup Vision Assessment System (Checkup; Verana Health, San Francisco, CA), can reliably monitor visual acuity (VA) and metamorphopsia remotely vs standard VA reference tests in the clinic. With the current COVID-19 pandemic, an even greater need for remote monitoring exists. Mobile tools enhance ability to monitor patients virtually by enabling remote monitoring of VA and Amsler grid findings. DESIGN Prospective, multicenter reliability analysis PARTICIPANTS: : Patients (N=108) with near corrected VA better than 20/200 and a diagnosis of age-related macular degeneration, diabetic retinopathy or healthy patients without retinal disease (best corrected visual acuity [BCVA] 20/32 or better). INTERVENTION Participants were tested with Checkup and reference VA and Amsler tests, with the order of testing (Checkup or reference) randomized. Patients monitored their vision using Checkup at least twice a week at home between office visits. MAIN OUTCOME MEASURES Near corrected VA, Amsler grid test results. RESULTS Agreement was strong between Checkup and reference tests for VA (r=0.86) and Amsler (sensitivity 93%, specificity 92%). Home vs clinic testing showed excellent agreement (r=0.96). Patients reported successful home use. There were no serious adverse events or discontinuations. Patients rated the usability of Checkup to be excellent. CONCLUSIONS There was good agreement between Checkup and in-clinic tests for VA and Amsler grid. The low variance of Checkup testing, agreement between in-clinic and home results, and excellent usability, support Checkup as a reliable method for monitoring retinal pathology in clinic and home settings.",2021,There were no serious adverse events or discontinuations.,"[' : Patients (N=108) with near corrected VA better than 20/200 and a diagnosis of age-related macular degeneration, diabetic retinopathy or healthy patients without retinal disease (best corrected visual acuity [BCVA] 20/32 or better', 'Diabetic Retinopathy and Age-related Macular Degeneration']","['mobile application, Checkup Vision Assessment System ']",['serious adverse events or discontinuations'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0442756', 'cui_str': 'Distance vision 6/60'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0035309', 'cui_str': 'Retinal disorder'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0024437', 'cui_str': 'Degenerative disorder of macula'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",108.0,0.0518782,There were no serious adverse events or discontinuations.,"[{'ForeName': 'Rahul N', 'Initials': 'RN', 'LastName': 'Khurana', 'Affiliation': 'Northern California Retina Vitreous Associates, Mountain View, CA; University of California, San Francisco, San Francisco, CA. Electronic address: rnkhurana@gmail.com.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Hoang', 'Affiliation': 'Clearside Biomedical, Alpharetta, GA.'}, {'ForeName': 'Arshad M', 'Initials': 'AM', 'LastName': 'Khanani', 'Affiliation': 'Sierra Eye Associates, Reno, NV; University of Nevada, Reno School of Medicine, Reno, NV.'}, {'ForeName': 'Nikolai', 'Initials': 'N', 'LastName': 'Steklov', 'Affiliation': 'doc.ai, San Francisco, CA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Singerman', 'Affiliation': 'Retina Associates of Cleveland, Cleveland, OH; Case Western Reserve University, Cleveland, OH; Bascom Palmer Eye Institute, Miami, FL.'}]",American journal of ophthalmology,['10.1016/j.ajo.2021.03.033'] 3065,33831327,"Topically applied mometasone furoate improves dysphagia in adult eosinophilic esophagitis - results from a double-blind, randomized, placebo-controlled trial.","OBJECTIVES Topical corticosteroids are considered a cornerstone in the treatment of patients with eosinophilic esophagitis. The aim of this study was to evaluate the benefit of using mometasone furoate spray versus placebo on dysphagia and health-related quality of life in these patients. MATERIAL AND METHODS Consecutive, newly diagnosed adult patients with eosinophilic esophagitis were randomized and treated with either 200 micrograms of orally administered topical mometasone furoate or placebo 4 times daily for 8 weeks. Symptoms and quality of life were evaluated using questionnaires including the Watson Dysphagia Scale, the European Organization for Research and Treatment of Cancer Quality of Life-Oesophageal Module 18 and the Short Form-36 before and after treatment. RESULTS In the intention-to-treat analysis ( n  = 36) the Watson Dysphagia Scale score after mometasone treatment was reduced by 6.5 (median, p  < .01) compared with 0 (median, ns) in the placebo group. The benefit of mometasone over placebo was significant ( p  < .05). In the per-protocol analysis ( n  = 33) the Watson Dysphagia Scale score was reduced by 5 (median, p  = .01) after mometasone treatment compared with 0 (median, ns) in the placebo group. The advantage of mometasone over the placebo was significant ( p  < .05). The benefit of using mometasoneas evaluated by the two quality of life questionnaires was, however, insignificant. CONCLUSIONS Our finding suggests that in adult patients with eosinophilic esophagitis, topical mometasone furoate exerts a beneficial effect compared with placebo regarding the main symptom, i.e., dysphagia. A corresponding benefit could not be verified regarding the various quality of life measurements. CLINICAL TRIAL REGISTRATION Mometasone-furoate for Treatment of Eosinophilic Esophagitis - a Randomized Placebo Controlled Study ClinicalTrials.gov Identifier (NCT02113267).",2021,The advantage of mometasone over the placebo was significant ( p  < .05).,"['patients with eosinophilic esophagitis', 'adult eosinophilic esophagitis ', 'adult patients with eosinophilic esophagitis', 'Consecutive, newly diagnosed adult patients with eosinophilic esophagitis']","['mometasone', '200 micrograms of orally administered topical mometasone furoate or placebo', 'placebo', 'Placebo', 'mometasone furoate spray versus placebo', 'mometasone furoate', 'Mometasone-furoate']","['Watson Dysphagia Scale, the European Organization for Research and Treatment of Cancer Quality of Life-Oesophageal Module 18 and the Short Form-36', 'dysphagia', 'dysphagia and health-related quality of life', 'Symptoms and quality of life', 'Watson Dysphagia Scale score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0341106', 'cui_str': 'Eosinophilic esophagitis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0360564', 'cui_str': 'Mometasone'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}]","[{'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.684913,The advantage of mometasone over the placebo was significant ( p  < .05).,"[{'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Tytor', 'Affiliation': 'Department of Otorhinolaryngology, NU Hospital Group, Trollhättan, Sweden.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Larsson', 'Affiliation': 'Department of Otorhinolaryngology, NU Hospital Group, Trollhättan, Sweden.'}, {'ForeName': 'Mogens', 'Initials': 'M', 'LastName': 'Bove', 'Affiliation': 'Department of Otorhinolaryngology, NU Hospital Group, Trollhättan, Sweden.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Johansson', 'Affiliation': 'Department of Otorhinolaryngology, Skaraborg Hospital, Skövde, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Bergquist', 'Affiliation': 'Department of ENT/H&N Surgery, Sahlgrenska University Hospital, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Goteborg, Sweden.'}]",Scandinavian journal of gastroenterology,['10.1080/00365521.2021.1906314'] 3066,33831317,Interactive effects of acute exercise and carbohydrate-energy replacement on insulin sensitivity in healthy adults.,"This study investigated whether carbohydrate-energy replacement immediately after prolonged endurance exercise attenuates insulin sensitivity the following morning, and whether exercise improves insulin sensitivity the following morning independent of an exercise-induced carbohydrate deficit. Oral glucose tolerance and whole-body insulin sensitivity were compared the morning after three evening conditions, involving: (1) treadmill exercise followed by carbohydrate replacement drink (200 or 150 g maltodextrin for males and females, respectively; CHO-replace); (2) treadmill exercise followed by a non-caloric, taste-matched placebo (CHO-deficit); or (3) seated rest with no drink provided (Rest). Treadmill exercise involved 90 minutes at ~80% age-predicted maximum heart rate. Seven males and two females (aged 23 ± 1 years; body mass index 24.0 ± 2.7 kg·m-2) completed all conditions in a randomized order. Matsuda index improved by 22% (2.2 [0.3, 4.0] au, p = .03) and HOMA2-IR improved by 10% (-0.04 [-0.08, 0.00] au, p = .04) in CHO-deficit versus CHO-replace, without corresponding changes in postprandial glycemia. Outcomes were similar between Rest and other conditions. These data suggest that improvements to insulin sensitivity in healthy populations following acute moderate/vigorous intensity endurance exercise may be dependent on the presence of a carbohydrate-energy deficit. NOVELTY • Restoration of carbohydrate balance following acute endurance exercise attenuated whole-body insulin sensitivity • Exercise per se failed to enhance whole-body insulin sensitivity • Maximizing or prolonging the post-exercise carbohydrate deficit may enhance acute benefits to insulin sensitivity.",2021,Exercise per se failed to enhance whole-body insulin sensitivity •,"['healthy adults', 'healthy populations', 'Seven males and two females (aged 23 ± 1 years; body mass index 24.0 ± 2.7 kg·m-2']","['CHO-replace); (2) treadmill exercise followed by a non-caloric, taste-matched placebo (CHO-deficit); or (3) seated rest with no drink provided (Rest', 'acute endurance exercise', 'carbohydrate-energy replacement', 'acute exercise and carbohydrate-energy replacement', 'Treadmill exercise', 'treadmill exercise followed by carbohydrate replacement drink']","['Matsuda index', 'Oral glucose tolerance and whole-body insulin sensitivity', 'Exercise per se failed to enhance whole-body insulin sensitivity •', 'HOMA2-IR', 'body insulin sensitivity •', 'maximum heart rate', 'insulin sensitivity', 'postprandial glycemia']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517635', 'cui_str': '2.7'}]","[{'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}]",,0.0294351,Exercise per se failed to enhance whole-body insulin sensitivity •,"[{'ForeName': 'Drusus A', 'Initials': 'DA', 'LastName': 'Johnson-Bonson', 'Affiliation': 'University of Bath, 1555, Department for Health, Bath, Somerset, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Narang', 'Affiliation': 'University of Bath, 1555, Department for Health, Bath, Somerset, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Russell G', 'Initials': 'RG', 'LastName': 'Davies', 'Affiliation': 'University of Bath, 1555, Department for Health, Bath, Somerset, United Kingdom of Great Britain and Northern Ireland; r.davies@bath.ac.uk.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Hengist', 'Affiliation': 'University of Bath, 1555, Department for Health, Bath, Somerset, United Kingdom of Great Britain and Northern Ireland; a.hengist@bath.ac.uk.'}, {'ForeName': 'Harry A', 'Initials': 'HA', 'LastName': 'Smith', 'Affiliation': 'University of Bath, 1555, Department for Health, Bath, Somerset, United Kingdom of Great Britain and Northern Ireland; h.a.smith@bath.ac.uk.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Watkins', 'Affiliation': 'University of Bath, 1555, Department for Health, Bath, Somerset, United Kingdom of Great Britain and Northern Ireland; j.d.watkins@bath.ac.uk.'}, {'ForeName': 'Harry L', 'Initials': 'HL', 'LastName': 'Taylor', 'Affiliation': 'Liverpool John Moores University, 4589, Research Institute for Sport and Exercise Sciences, Liverpool, Merseyside, United Kingdom of Great Britain and Northern Ireland; h.l.taylor@2019.ljmu.ac.uk.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Walhin', 'Affiliation': 'University of Bath, 1555, Department for Health, Bath, Somerset, United Kingdom of Great Britain and Northern Ireland; J.Walhin@bath.ac.uk.'}, {'ForeName': 'Javier T', 'Initials': 'JT', 'LastName': 'Gonzalez', 'Affiliation': 'University of Bath, 1555, Department for Health, Bath, Somerset, United Kingdom of Great Britain and Northern Ireland; J.T.Gonzalez@bath.ac.uk.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Betts', 'Affiliation': 'University of Bath, 1555, Department for Health, Bath, Somerset, United Kingdom of Great Britain and Northern Ireland; j.betts@bath.ac.uk.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2020-1043'] 3067,33831305,Improvement in palliative care quality in rural nursing homes through information and communication technology-driven interprofessional collaboration.,"INTRODUCTION Information and communication technology (ICT) can facilitate long-term care. In long-term care, effective communication among healthcare professionals is vital to reduce inappropriate emergency transfer and eventual death in hospitals. As nursing homes in rural areas lack adequate healthcare resources, ICT can reduce the burden on professionals, leading to adequate long-term care. This study investigated whether the application of ICT-based communication can reduce the number of emergency transportations to, and death in, hospitals in rural facilities. METHODS This was an interventional study. Participants were patients living in a rural nursing home in the westernmost part of Unnan City in Shimane prefecture, Japan. The intervention group was defined as patients living therein after application of the ICT system and the control group as patients living therein before application of the ICT system. The primary outcome was the rate of emergency transportation to hospitals and the secondary outcome was the rate of death in the nursing home. RESULTS The total number of participants was 96 (48 in the ICT usage group and 48 in the control group), and the average age of this sample was 89.5 years. The rate of emergency transportation was 54.2% (26/48) in the control group and 29.2% (14/48) in the intervention group (p=0.022). The rate of end-of-life care in the nursing home was 33.3% (3/9) in the control group and 84.6% (11/13) in the intervention group (p<0.001). CONCLUSION ICT-driven nursing home care can reduce emergency transportation from nursing homes and enable patients in nursing homes to remain there longer, leading to an increase in end-of-life care in nursing homes, which provides hope to patients and their families. Therefore, these findings highlight that the continuous provision of ICT can facilitate end-of-life care in nursing homes.",2021,"This study investigated whether the application of ICT-based communication can reduce the number of emergency transportations to, and death in, hospitals in rural facilities. ","['Participants were patients living in a rural nursing home in the westernmost part of Unnan City in Shimane prefecture, Japan', 'rural nursing homes', 'hospitals in rural facilities', 'of participants was 96 (48 in the ICT usage group and 48 in the control group), and the average age of this sample was 89.5 years']","['Information and communication technology (ICT', 'ICT-based communication', 'ICT-driven nursing home care']","['rate of death in the nursing home', 'rate of emergency transportation to hospitals', 'rate of emergency transportation', 'total number', 'rate of end-of-life care']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C3658224', 'cui_str': 'Remote Rural Nursing'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0683867', 'cui_str': 'Information Technology'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0683867', 'cui_str': 'Information Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039548', 'cui_str': 'Terminal care'}]",,0.0496598,"This study investigated whether the application of ICT-based communication can reduce the number of emergency transportations to, and death in, hospitals in rural facilities. ","[{'ForeName': 'Ryuichi', 'Initials': 'R', 'LastName': 'Ohta', 'Affiliation': 'Community Care, Unnan City Hospital, Unnan City, Japan ryuichiohta0120@gmail.com.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Ryu', 'Affiliation': 'Community Care, Unnan City Hospital, Unnan City, Japan yoshiyoshiryuryu.hpydys@gmail.com.'}]",Rural and remote health,['10.22605/RRH6450'] 3068,33831271,A randomized single-center controlled trial of synchronized intermittent mandatory ventilation with heliox in newborn infants with meconium aspiration syndrome.,"OBJECTIVE This study aimed to investigate the beneficial effects of synchronized intermittent mandatory ventilation (SIMV) with heliox in newborn infants with meconium aspiration syndrome (MAS). METHODS Seventy-one newborn infants with MAS in the neonatal intensive care unit (NICU) of Daping Hospital of Army Medical University were enrolled in the trial. Infants treated with SIMV were randomized and divided into the heliox group (n = 35) and control group (n = 36). The heliox group received heliox for 6 h followed by air-oxygen mixed gas, and the control group received air-oxygen mixed gas. The primary outcome measures were PaO 2 /FiO 2 (P/F) and the extubation time. The secondary outcome measures were the incidence of mechanical ventilation complications, hospital length of stay in the NICU, blood gas analysis, and inflammation markers. RESULTS The P/F in the heliox group was significantly better than that in the control group (p < .001). The extubation time and hospital length of stay in the NICU in the heliox group were shorter than those in the control group (p < .001). The inflammation markers at 6 h and myocardial injury markers at 24 h were decreased compared with those at 0 h, and those in the heliox group were more significantly decreased than those in the control group ([interleukin {IL}-6/IL-8/tumor necrosis factor α] p < .001, [C-reaction protein] p = .012; [creatine kinase] p < .001, [CK-MB] p = .041). CONCLUSION Heliox appears to be more effective in reducing the length of ventilation and increasing carbon dioxide eliminations than an air-oxygen mixture in infants with MAS under the support of SIMV.",2021,The P/F in the heliox group was significantly better than that in the control group (p < .001).,"['newborn infants with meconium aspiration syndrome', 'newborn infants with meconium aspiration syndrome (MAS', 'Infants treated with SIMV', 'Seventy-one newborn infants with MAS in the neonatal intensive care unit (NICU) of Daping Hospital of Army Medical University were enrolled in the trial']","['heliox for 6\u2009h followed by air-oxygen mixed gas, and the control group received air-oxygen mixed gas', 'synchronized intermittent mandatory ventilation (SIMV) with heliox', 'creatine kinase', 'synchronized intermittent mandatory ventilation with heliox']","['myocardial injury markers', 'PaO 2 /FiO 2 (P/F) and the extubation time', 'extubation time and hospital length of stay in the NICU', 'length of ventilation and increasing carbon dioxide eliminations', 'inflammation markers', 'incidence of mechanical ventilation complications, hospital length of stay in the NICU, blood gas analysis, and inflammation markers']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0025048', 'cui_str': 'Meconium aspiration syndrome'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0278335', 'cui_str': 'Synchronized intermittent mandatory ventilation'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0045587', 'cui_str': '2,6-diaminopurine'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0062185', 'cui_str': 'heliox'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0278335', 'cui_str': 'Synchronized intermittent mandatory ventilation'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}]","[{'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1868711', 'cui_str': 'Mechanical ventilation complication'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}]",71.0,0.0561017,The P/F in the heliox group was significantly better than that in the control group (p < .001).,"[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Pediatrics, North-Kuanren General Hospital, Chongqing, China.'}, {'ForeName': 'Shifang', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': 'Department of Pediatrics, North-Kuanren General Hospital, Chongqing, China.'}, {'ForeName': 'Leilei', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Pediatrics, Southwest Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""Department of Neonatology, Chongqing Key Laboratory of Pediatrics, Ministry of Education Key Laboratory of Child Development and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, National Clinical Research Center for Child Health and Disorders, Children's Hospital of Chongqing Medical University, Chongqing, China.""}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Pediatrics, Daping Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Wanwei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Pediatrics, Daping Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of Pediatrics, Daping Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': ""Department of Neonatology, Chongqing Key Laboratory of Pediatrics, Ministry of Education Key Laboratory of Child Development and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, National Clinical Research Center for Child Health and Disorders, Children's Hospital of Chongqing Medical University, Chongqing, China.""}]",Pediatric pulmonology,['10.1002/ppul.25390'] 3069,33831250,A NSQIP-based randomized clinical trial evaluating choice of prophylactic antibiotics for pancreaticoduodenectomy.,"Surgical site infection after pancreaticoduodenectomy is often caused by pathogens resistant to standard prophylactic antibiotics, suggesting that broad-spectrum antibiotics may be more effective prophylactic agents. This article describes the rationale and methodology underlying a multicenter randomized trial evaluating piperacillin-tazobactam compared with cefoxitin for surgical site infection prevention following pancreaticoduodenectomy. As the first US randomized surgical trial to utilize a clinical registry for data collection, this study serves as proof of concept for registry-based clinical trials.",2021,"Surgical site infection after pancreaticoduodenectomy is often caused by pathogens resistant to standard prophylactic antibiotics, suggesting that broad-spectrum antibiotics may be more effective prophylactic agents.",[],"['piperacillin-tazobactam', 'cefoxitin']",[],[],"[{'cui': 'C0250480', 'cui_str': 'Piperacillin and tazobactam'}, {'cui': 'C0007557', 'cui_str': 'Cefoxitin'}]",[],,0.14016,"Surgical site infection after pancreaticoduodenectomy is often caused by pathogens resistant to standard prophylactic antibiotics, suggesting that broad-spectrum antibiotics may be more effective prophylactic agents.","[{'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Brajcich', 'Affiliation': 'Division of Research and Optimal Patient Care, American College of Surgeons, Chicago, Illinois, USA.'}, {'ForeName': 'Clifford Y', 'Initials': 'CY', 'LastName': 'Ko', 'Affiliation': 'Division of Research and Optimal Patient Care, American College of Surgeons, Chicago, Illinois, USA.'}, {'ForeName': 'Jason B', 'Initials': 'JB', 'LastName': 'Liu', 'Affiliation': 'Division of Research and Optimal Patient Care, American College of Surgeons, Chicago, Illinois, USA.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Ellis', 'Affiliation': 'Division of Research and Optimal Patient Care, American College of Surgeons, Chicago, Illinois, USA.'}, {'ForeName': 'Michael I', 'Initials': 'MI', 'LastName': 'D Angelica', 'Affiliation': 'Division of Hepatopancreatobiliary Surgery, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.'}]",Journal of surgical oncology,['10.1002/jso.26402'] 3070,33831216,Comparison of early postoperative cytokine changes in patients undergoing intubated and non-intubated thoracic surgery: a randomized controlled trial.,"OBJECTIVES The inflammatory response after surgery is associated with patient prognosis. Patients who undergo thoracic surgery exhibit a profound systemic inflammatory response due to the surgical procedures used and application of one-lung ventilation. The aim of this study was to compare perioperative inflammatory changes in patients after intubated and non-intubated thoracic surgery for primary lung cancer resection. METHODS This prospective randomized controlled study included forty patients who underwent surgical resection for stage I non-small-cell lung cancer. Blood samples for cytokine analysis were collected just before induction, at 1 and 24 h after surgery. Levels of the pro-inflammatory cytokine and anti-inflammatory cytokines were measured using quantitative sandwich enzyme immunoassay kits. RESULTS The basal values of cytokines were comparable between 2 groups. Within each group, the postoperative levels of interleukin (IL)-1, IL-6 and tumour necrosis factor-α increased, while those of IL-4 and IL-10 did not change significantly. The levels of IL-6 and tumour necrosis factor-α were significantly lower in group NI at 1 and 24 h postoperatively. Other cytokines did not differ in both groups during postoperative period. The IL-6/IL-10 ratio at 1 h after surgery was lower in non-intubated patients than in intubated patients, but there was no difference at 24 h after surgery. CONCLUSIONS Non-intubated thoracic surgery may attenuate the early inflammatory cytokine changes following major resection for primary lung cancer compared with intubated conventional surgery. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov registry number NCT04007354.",2021,The levels of IL-6 and tumour necrosis factor-α were significantly lower in group NI at 1 and 24 h postoperatively.,"['forty patients who underwent surgical resection for stage I non-small-cell lung cancer', 'Patients who undergo thoracic surgery exhibit a profound systemic inflammatory response due to the surgical procedures used and application of one-lung ventilation', 'patients after intubated and non-intubated thoracic surgery for primary lung cancer resection', 'patients undergoing intubated and non-intubated thoracic surgery']",[],"['IL-6/IL-10 ratio', 'postoperative levels of interleukin (IL)-1, IL-6 and tumour necrosis factor-α', 'IL-4 and IL-10', 'basal values of cytokines', 'levels of IL-6 and tumour necrosis factor-α', 'Levels of the pro-inflammatory cytokine and anti-inflammatory cytokines', 'perioperative inflammatory changes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0278504', 'cui_str': 'Non-small cell lung cancer stage I'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0439808', 'cui_str': 'Profound'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}]",[],"[{'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",40.0,0.35262,The levels of IL-6 and tumour necrosis factor-α were significantly lower in group NI at 1 and 24 h postoperatively.,"[{'ForeName': 'Joonpyo', 'Initials': 'J', 'LastName': 'Jeon', 'Affiliation': ""Department of Anesthesia and Pain Medicine, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Sookwhan', 'Initials': 'S', 'LastName': 'Sung', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Ewha Womans University Seoul Hospital, Seoul, Korea.'}, {'ForeName': 'Youngkyu', 'Initials': 'Y', 'LastName': 'Moon', 'Affiliation': ""Department of Thoracic and Cardiovascular Surgery, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Jungmin', 'Initials': 'J', 'LastName': 'Koo', 'Affiliation': ""Department of Anesthesia and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Kwanyong', 'Initials': 'K', 'LastName': 'Hyun', 'Affiliation': ""Department of Thoracic and Cardiovascular Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Kyungdo', 'Initials': 'K', 'LastName': 'Han', 'Affiliation': 'Department of Statistics and Actuarial Science, Soongsil University, Seoul, Korea.'}, {'ForeName': 'Wonjung', 'Initials': 'W', 'LastName': 'Hwang', 'Affiliation': ""Department of Anesthesia and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}]",Interactive cardiovascular and thoracic surgery,['10.1093/icvts/ivaa265'] 3071,33831213,Exenatide Adjunct to Nicotine Patch Facilitates Smoking Cessation and May Reduce Post-Cessation Weight Gain: a Pilot Randomized Controlled Trial.,"INTRODUCTION Approved pharmacological treatments for smoking cessation are modestly effective, underscoring the need for improved pharmacotherapies. Glucagon-like peptide-1 receptor (GLP-1R) agonists attenuate the rewarding effects of nicotine in preclinical studies. We examined the efficacy of extended-release exenatide, a GLP-1R agonist, combined with nicotine replacement therapy (NRT, patch) for smoking cessation, craving and withdrawal symptoms, with post-cessation body weight as secondary outcome. METHODS Eighty-four prediabetic and/or overweight smokers were randomized (1:1) to once-weekly placebo or exenatide, 2 mg, subcutaneously. All participants received NRT (21 mg) and brief smoking cessation counseling. Seven-day point prevalence abstinence (expired CO level ≤5 ppm), craving, withdrawal and post-cessation body weight were assessed following 6 weeks of treatment. A Bayesian approach for analyzing generalized linear models yielded posterior probabilities (PP) to quantify the evidence favoring hypothesized effects of treatment on the study outcomes. RESULTS Exenatide increased the risk for smoking abstinence compared to placebo (46.3% and 26.8%, respectively), (RR = 1.70; 95% credible interval = [0.96, 3.27]; PP = 96.5%). Exenatide reduced end-of-treatment craving in the overall sample and withdrawal among abstainers. Post-cessation body weight was 5.6 pounds lower in the exenatide group compared to placebo (PP=97.4%). Adverse events were reported in 9.5% and 2.3% of participants in the exenatide and placebo groups, respectively. CONCLUSIONS Exenatide, in combination with the NRT improved smoking abstinence, reduced craving and withdrawal symptoms, and decreased weight gain among abstainers. Findings suggest that the GLP-1R agonist strategy is worthy of further research in larger, longer duration studies. IMPLICATIONS Despite considerable progress in tobacco control, cigarette smoking remains the leading cause of preventable disease, disability, and death. In this pilot study, we showed that extended-release exenatide, a glucagon-like peptide-1 receptor agonist, added to the nicotine patch, improved abstinence and mitigated post-cessation body weight gain compared to patch alone. Further research is needed to confirm these initial positive results.",2021,"Adverse events were reported in 9.5% and 2.3% of participants in the exenatide and placebo groups, respectively. ","['prediabetic and/or overweight smokers', 'Eighty-four']","['brief smoking cessation counseling', 'NRT', 'extended-release exenatide, a GLP-1R agonist, combined with nicotine replacement therapy (NRT, patch', 'placebo', 'Exenatide', 'Nicotine Patch', 'exenatide', 'placebo or exenatide', 'exenatide and placebo']","['smoking abstinence, reduced craving and withdrawal symptoms', 'prevalence abstinence', 'Adverse events', 'expired CO level ≤5\u200appm), craving, withdrawal and post-cessation body weight', 'weight gain', 'Post-cessation body weight', 'risk for smoking abstinence']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4319623', 'cui_str': '84'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}]",,0.110383,"Adverse events were reported in 9.5% and 2.3% of participants in the exenatide and placebo groups, respectively. ","[{'ForeName': 'Luba', 'Initials': 'L', 'LastName': 'Yammine', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center at Houston (UTHealth), McGovern Medical School, BBSB, Houston, TX.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Green', 'Affiliation': 'Department of Pediatrics, Center for Clinical Research and Evidence-Based Medicine, UTHealth, McGovern Medical School, Houston, TX.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Kosten', 'Affiliation': 'Psychiatry, Pharmacology, Neuroscience, Immunology, Baylor College of Medicine, One Baylor Plaza, Houston Texas.'}, {'ForeName': 'Constanza', 'Initials': 'C', 'LastName': 'de Dios', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, UTHealth, McGovern Medical School, Houston, TX.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Suchting', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, UTHealth, McGovern Medical School, Houston, TX.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Lane', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, UTHealth, McGovern Medical School, Houston, TX.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Verrico', 'Affiliation': 'Medical Center, Holcombe Blvd. Houston Texas.'}, {'ForeName': 'Joy M', 'Initials': 'JM', 'LastName': 'Schmitz', 'Affiliation': 'Center for Neurobehavioral Research on Addiction, Louis A. Faillace, M.D., Department of Psychiatry and Behavioral Sciences, UTHealth, McGovern Medical School, Houston, TX.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntab066'] 3072,33823377,Amelioration of Levetiracetam-Induced Behavioral Side Effects by Pyridoxine: Randomized Double-Blind Controlled Study.,"BACKGROUND Levetiracetam is a relatively new-generation antiseizure drug approved for the treatment of focal and generalized seizures. Despite its favorable side effect profile and minimal drug-drug interactions, neuropsychiatric side effects are reported in up to 13% of children. A few case series have suggested that supplementation of pyridoxine may mitigate these side effects, but controlled trials are lacking. To address this issue, a randomized interventional study was carried out in a pediatric tertiary hospital to qualify and quantify the potential beneficial effect of pyridoxine in attenuating the neuropsychiatric side effects of levetiracetam in children. METHODS A total of 105 children with epilepsy who were taking levetiracetam (as a monotherapy or an adjunct) who showed behavioral symptoms coinciding with the start of levetiracetam, were included. Patients randomly and blindly received either a therapeutic (pyridoxine group, 46 of 105, 44%) or a homeopathic dose of pyridoxine (placebo, 59 of 105, 56%). A 30-item behavioral checklist was used to qualify and quantify the behavioral side effects at baseline and at different time points following initiation of treatment. RESULTS Both placebo and pyridoxine groups experienced a statistical reduction in behavioral scores when compared with baseline. Our study indicated that although there was a placebo effect, the improvement in neuropsychiatric symptoms was more prominent in children who received therapeutic doses of pyridoxine. CONCLUSIONS These data provide clinicians with pertinent evidence-based information that suggests that a trial of pyridoxine in patients who experience behavioral side effects due to the use of levetiracetam may avoid unnecessary change of antiseizure medications.",2021,Both placebo and pyridoxine groups experienced a statistical reduction in behavioral scores when compared with baseline.,"['children', '105 children with epilepsy who were taking levetiracetam (as a monotherapy or an adjunct) who showed behavioral symptoms coinciding with the start of levetiracetam, were included']","['pyridoxine', 'Pyridoxine', 'therapeutic (pyridoxine', 'Levetiracetam', 'placebo', 'levetiracetam', 'homeopathic dose of pyridoxine (placebo']","['behavioral scores', 'neuropsychiatric symptoms']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0034272', 'cui_str': 'pyridoxine'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0684199', 'cui_str': 'Homeopathic therapy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}]",105.0,0.306995,Both placebo and pyridoxine groups experienced a statistical reduction in behavioral scores when compared with baseline.,"[{'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Mahmoud', 'Affiliation': 'Department of Pediatric Neurology, National Neuroscience Institute, King Fahad Medical City, Riyadh, Kingdom of Saudi Arabia. Electronic address: amahmoud2000@hotmail.com.'}, {'ForeName': 'Sadia', 'Initials': 'S', 'LastName': 'Tabassum', 'Affiliation': 'Department of Pediatric Neurology, National Neuroscience Institute, King Fahad Medical City, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Shoaa', 'Initials': 'S', 'LastName': 'Al Enazi', 'Affiliation': 'Department of Pediatric Neurology, National Neuroscience Institute, King Fahad Medical City, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Nahed', 'Initials': 'N', 'LastName': 'Lubbad', 'Affiliation': 'Pharmacy service administration, King Fahad Medical City, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Al Wadei', 'Affiliation': 'Department of Pediatric Neurology, National Neuroscience Institute, King Fahad Medical City, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Al Otaibi', 'Affiliation': 'Department of Pediatric Neurology, National Neuroscience Institute, King Fahad Medical City, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Lamya', 'Initials': 'L', 'LastName': 'Jad', 'Affiliation': 'Department of Pediatric Neurology, National Neuroscience Institute, King Fahad Medical City, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Ruba', 'Initials': 'R', 'LastName': 'Benini', 'Affiliation': 'Department of Pediatric Neurology, National Neuroscience Institute, King Fahad Medical City, Riyadh, Kingdom of Saudi Arabia; Sidra Medicine, Division of Pediatric Neurology, Doha, Qatar.'}]",Pediatric neurology,['10.1016/j.pediatrneurol.2021.02.010'] 3073,33823295,A stepped randomized trial to promote colorectal cancer screening in a nationwide sample of U.S. Veterans.,"BACKGROUND Colorectal cancer (CRC) screening (CRCS) facilitates early detection and lowers CRC mortality. OBJECTIVES To increase CRCS in a randomized trial of stepped interventions. Step 1 compared three modes of delivery of theory-informed minimal cue interventions. Step 2 was designed to more intensively engage those not completing CRCS after Step 1. METHODS Recruitment packets (60,332) were mailed to a random sample of individuals with a record of U.S. military service during the Vietnam-era. Respondents not up-to-date with CRCS were randomized to one of four Step 1 groups: automated telephone, telephone, letter, or survey-only control. Those not completing screening after Step 1 were randomized to one of three Step 2 groups: automated motivational interviewing (MI) call, counselor-delivered MI call, or Step 2 control. Intention-to-treat (ITT) analyses assessed CRCS on follow-up surveys mailed after each step. RESULTS After Step 1 (n = 1784), CRCS was higher in the letter, telephone, and automated telephone groups (by 1%, 5%, 7%) than in survey-only controls (43%), although differences were not statistically significant. After Step 2 (n = 516), there were nonsignificant increases in CRCS in the two intervention groups compared with the controls. CRCS following any combination of stepped interventions overall was 7% higher (P = 0.024) than in survey-only controls (55.6%). CONCLUSIONS In a nationwide study of Veterans, CRCS after each of two stepped interventions of varying modes of delivery did not differ significantly from that in controls. However, combined overall, the sequence of stepped interventions significantly increased CRCS.",2021,"After Step 1 (n = 1784), CRCS was higher in the letter, telephone, and automated telephone groups (by 1%, 5%, 7%) than in survey-only controls (43%), although differences were not statistically significant.","['Recruitment packets (60,332) were mailed to a random sample of individuals with a record of U.S. military service during the Vietnam-era', 'nationwide sample of U.S. veterans', 'Respondents not up-to-date with CRCS', 'Colorectal cancer']","['automated motivational interviewing (MI) call, counselor-delivered MI call, or Step 2 control', 'colorectal cancer screening', 'automated telephone, telephone, letter, or survey-only control', 'CRC) screening (CRCS', 'Intention-to-treat (ITT) analyses assessed CRCS']",['CRCS'],"[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C1641805', 'cui_str': 'Packet - unit of product usage'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2355580', 'cui_str': 'Record of'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C3714797', 'cui_str': 'Military service'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C1521863', 'cui_str': 'estrogen receptor alpha, human'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C1571885', 'cui_str': 'Professional counselor'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}]","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]",60332.0,0.0922815,"After Step 1 (n = 1784), CRCS was higher in the letter, telephone, and automated telephone groups (by 1%, 5%, 7%) than in survey-only controls (43%), although differences were not statistically significant.","[{'ForeName': 'Sally W', 'Initials': 'SW', 'LastName': 'Vernon', 'Affiliation': 'Department of Health Promotion and Behavioral Sciences, UTHealth School of Public Health, Houston, TX, United States. Electronic address: sally.w.vernon@uth.tmc.edu.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Del Junco', 'Affiliation': 'Department of Surgery, Center for Translational Injury Research, The University of Texas McGovern Medical School, Houston, TX, United States.'}, {'ForeName': 'Sharon P', 'Initials': 'SP', 'LastName': 'Coan', 'Affiliation': 'Department of Health Promotion and Behavioral Sciences, UTHealth School of Public Health, Houston, TX, United States.'}, {'ForeName': 'Caitlin C', 'Initials': 'CC', 'LastName': 'Murphy', 'Affiliation': 'Department of Population & Data Sciences, University of Texas Southwestern Medical Center, Dallas, TX, United States.'}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Walters', 'Affiliation': 'Health Behavior and Health Systems, University of North Texas Health Science Center, Ft. Worth, TX, United States.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Friedman', 'Affiliation': 'Medical Information Systems Unit, Boston University School of Medicine and Boston Medical Center, Boston, MA, United States.'}, {'ForeName': 'Lori A', 'Initials': 'LA', 'LastName': 'Bastian', 'Affiliation': 'General Internal Medicine, VA Connecticut, West Haven, CT 06516 and Department of Medicine, Yale University School of Medicine, New Haven, CT 06510, United States.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Fisher', 'Affiliation': 'Durham VAMC, Duke University, Durham, NC, United States.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Lairson', 'Affiliation': 'Department of Management Policy and Community Health, UTHealth School of Public Health, Houston, TX, United States.'}, {'ForeName': 'Ronald E', 'Initials': 'RE', 'LastName': 'Myers', 'Affiliation': 'Division of Population Science, Department of Medical Oncology, Sidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106392'] 3074,33825723,"[Randomized study of tolerability, safety and efficacy of Pletax in intermittent claudication].","AIM This study was aimed at assessing tolerability, safety and therapeutic efficacy of Pletax® (cilostazol) compared with Trental® (pentoxifylline) in patients with moderate-to-severe intermittent claudication. PATIENTS AND METHODS The study included a total of one hundred 40-to-65-year-old patients presenting with confirmed diagnosis of moderate-to-severe intermittent claudication. Depending on the therapeutic regimen, the patients were divided into two groups. Group 1: 50 patients orally took Pletax® (cilostazol) at a dose of 100 mg twice daily 30 minutes before meals or 2 hours after meals together with conventional therapy. Group 2: 50 patients took oral Trental® (pentoxifylline) in a dose of 400 mg 3 times daily 30 minutes before meals or 2 hours after meals along with conventional therapy. The duration of the follow up period amounted to 24 weeks for both groups. The treadmill test was carried out at room temperature, with the running track tilt angle of 0° at a speed of 3 km/h. The primary parameters of efficacy were as follows: the dynamics of the minimal walking distance (a distance walked by the patient until the appearance of pain in the extremity) and dynamics of the maximal walking distance (a distance walked by the patients until full stop due to pain in the extremity). RESULTS Analysing efficacy demonstrated higher results of Pletax® compared with Trental®. The obtained findings suggested that Pletax® showed a significant clinical effect as soon as at 2 weeks, followed by advantage during the whole period of follow up. Analysing the parameters of the minimal and maximal walking distances in the group of patients taking Pletax® demonstrated clear superiority over the Trental® group as soon as by week 2 of administration, which preserved during the whole follow-up period. The minimal pain-free walking distance in the Pletax group at baseline amounted to 92.9±83.4 m (Trental group - 92.3±78.4; p=0.3), followed by an increase at week 8 to 126±115 m (Trental group - 116±96.3; p=0.51), at week 16 to 136±116 m (Trental group - 118±95.5; p=0.04), at week 24 to 149±126 b (Trental group - 127±98.9; p=0.01). At the same time, the effect of Pletax® and Trental® on the secondary parameter of efficacy, i.e., the ankle-brachial index was comparable: at baseline - 0.472 and 0.482 (p=0.28), at 2 weeks - 0.48 and 0.483 (p=031), at 8 weeks - 0.49 and 0.485 (p=0.74), at 16 weeks - 0.494 and 0.492 (p=0.2), at 24 weeks - 0.501 and 0.496 (p=0.45). CONCLUSION The obtained findings demonstrated advantages of Pletax® over Trental®, manifesting themselves in the achievement of the highest parameters by such criteria as the minimal and maximal walking distance. High safety and efficacy of Pletax® were confirmed by low frequency of unfavourable events during therapy.",2021,"Analysing the parameters of the minimal and maximal walking distances in the group of patients taking Pletax® demonstrated clear superiority over the Trental® group as soon as by week 2 of administration, which preserved during the whole follow-up period.","['50 patients took', 'one hundred 40-to-65-year-old patients presenting with confirmed diagnosis of moderate-to-severe intermittent claudication', 'patients with moderate-to-severe intermittent claudication']","['Pletax', 'Pletax® (cilostazol', 'Trental® (pentoxifylline', 'oral Trental® (pentoxifylline', '50 patients orally took Pletax® (cilostazol']","['tolerability, safety and therapeutic efficacy', 'minimal pain-free walking distance', 'dynamics of the minimal walking distance (a distance walked by the patient until the appearance of pain in the extremity) and dynamics of the maximal walking distance (a distance walked by the patients until full stop due to pain in the extremity', 'ankle-brachial index', 'tolerability, safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0021775', 'cui_str': 'Intermittent claudication'}]","[{'cui': 'C0055729', 'cui_str': 'cilostazol'}, {'cui': 'C0699487', 'cui_str': 'Trental'}, {'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1328319', 'cui_str': 'Ankle brachial pressure index'}]",,0.0245786,"Analysing the parameters of the minimal and maximal walking distances in the group of patients taking Pletax® demonstrated clear superiority over the Trental® group as soon as by week 2 of administration, which preserved during the whole follow-up period.","[{'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Kazantsev', 'Affiliation': 'Department of Surgery #3, Alexandrovskaya Hospital, Saint Petersburg, Russia.'}, {'ForeName': 'S V', 'Initials': 'SV', 'LastName': 'Goriunov', 'Affiliation': 'Department of Surgery #17, Municipal Clinical Hospital #15 named after O.M. Filatov under the Moscow Healthcare Department, Moscow, Russia.'}, {'ForeName': 'O B', 'Initials': 'OB', 'LastName': 'Ershova', 'Affiliation': 'Clinical Hospital of Emergency Medical Care named after N.V. Solovyev, Yaroslavl, Russia.'}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Erofeeva', 'Affiliation': 'Clinic ""Bessalar"", Centre of Clinical Trials, Moscow, Russia.'}, {'ForeName': 'E V', 'Initials': 'EV', 'LastName': 'Gurgenian', 'Affiliation': 'Therapeutic Department #11, Municipal Clinical Hospital #23, Moscow, Russia.'}]",Angiologiia i sosudistaia khirurgiia = Angiology and vascular surgery,['10.33529/ANGIO2020405'] 3075,32447657,The Role of Anti-PD-1/PD-L1 in the Treatment of Skin Cancer.,"Skin cancers remain the most common group of cancers globally, and the incidence continues to rise. Although localized skin cancers tend to have excellent outcomes following surgical excisions, the less common cases that become surgically unresectable or metastatic have been associated with poor prognosis and suboptimal treatment responses to cytotoxic chemotherapy. Development of monoclonal antibodies to programmed cell death-1 receptor and its ligand (PD-1/PD-L1) have transformed the management of metastatic melanoma, squamous cell carcinoma, and Merkel cell carcinoma. These agents, as monotherapies, are associated with response rates of approximately 40-60%, many of which persist durably. Further efficacy is observed with combination immunotherapy in advanced melanoma. Early reports suggest similar activity in locally advanced or metastatic basal cell carcinoma. In this review, we describe common molecular features of skin cancers that may render them particularly susceptible to anti-PD-1/PD-L1 and detail results from key clinical trials of these agents across skin cancers. Overall, the superior response rates of skin cancer to anti-PD-1/PD-L1 compared with other solid tumor types are likely due, at least in part, to a high mutational burden and, in Merkel cell carcinoma, viral etiology. Although melanoma has been rigorously studied in the setting of anti-PD-1/PD-L1 treatment, more research is needed for the other skin cancer types to establish toxicity profiles, responses, and quality-of-life outcomes.",2020,"Overall, the superior response rates of skin cancer to anti-PD-1/PD-L1 compared with other solid tumor types are likely due, at least in part, to a high mutational burden and, in Merkel cell carcinoma, viral etiology.","['advanced melanoma', 'Skin Cancer', 'locally advanced or metastatic basal cell carcinoma']",['Anti-PD-1/PD-L1'],[],"[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0007114', 'cui_str': 'Malignant neoplasm of skin'}, {'cui': 'C1304306', 'cui_str': 'Metastatic basal cell carcinoma'}]",[],[],,0.168735,"Overall, the superior response rates of skin cancer to anti-PD-1/PD-L1 compared with other solid tumor types are likely due, at least in part, to a high mutational burden and, in Merkel cell carcinoma, viral etiology.","[{'ForeName': 'James Randall', 'Initials': 'JR', 'LastName': 'Patrinely', 'Affiliation': 'Vanderbilt University School of Medicine, 777 PRB, 2220 Pierce Ave, Nashville, TN, 37232, USA. james.r.patrinely@vanderbilt.edu.'}, {'ForeName': 'Anna K', 'Initials': 'AK', 'LastName': 'Dewan', 'Affiliation': 'Department of Dermatology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Douglas B', 'Initials': 'DB', 'LastName': 'Johnson', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}]","BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy",['10.1007/s40259-020-00428-9'] 3076,33829804,"Intersecting minority statuses and tryptophan degradation among stimulant-using, sexual minority men living with HIV.","BACKGROUND Disclosure of one's sexual orientation as a sexual-minority (SM) person (i.e., being ""out"") may affect HIV-related health outcomes. This longitudinal study examined whether race/ethnicity moderated effects of outness on the plasma kynurenine/tryptophan (KT) ratio, a marker of dysregulated serotonin metabolism due to immune activation that predicts clinical HIV progression. METHODS Participants were African American, Hispanic/Latino, and non-Hispanic White, methamphetamine-using SM men living with HIV (N = 97) who completed self-report scales of outness and SM stress at baseline for a randomized controlled trial of a positive affect intervention. Linear mixed modeling was used to test whether race/ethnicity and experimental condition moderated the association of baseline outness with the KT ratio at baseline, 6, 12, and 15 months controlling for SM stress, sociodemographics, HIV disease markers, and recent stimulant use. RESULTS The interactions of outness by race/ethnicity and outness by experimental condition on the KT ratio were significant. Greater outness predicted a lower KT ratio over time in non-Hispanic White SM men, but not among SM men of color (MOC). Greater outness predicted a lower KT ratio over time for SM men in the control, but not among those in the intervention arm. CONCLUSION Being more out may be protective for non-Hispanic White SM men, but not for their SM MOC peers. Outness mattered for participants who did not receive the positive affect intervention. Findings underscore the potentially different contexts and consequences of outness depending on SM men's race/ethnicity and whether they received a positive affect intervention. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"Greater outness predicted a lower KT ratio over time in non-Hispanic White SM men, but not among SM men of color (MOC).","['Participants were African American, Hispanic/Latino, and non-Hispanic White, methamphetamine-using SM men living with HIV (N = 97) who completed self-report scales of outness and SM stress at baseline for a randomized controlled trial of a positive affect intervention', 'sexual minority men living with HIV']",[],"['plasma kynurenine/tryptophan (KT) ratio', 'KT ratio']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C4277573', 'cui_str': 'Lesbigay Persons'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],"[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0022818', 'cui_str': 'Kynurenine'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.160264,"Greater outness predicted a lower KT ratio over time in non-Hispanic White SM men, but not among SM men of color (MOC).","[{'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Vincent', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Adam W', 'Initials': 'AW', 'LastName': 'Carrico', 'Affiliation': 'Department of Public Health Sciences.'}, {'ForeName': 'Samantha E', 'Initials': 'SE', 'LastName': 'Dilworth', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Fuchs', 'Affiliation': 'Division of Biological Chemistry.'}, {'ForeName': 'Torsten B', 'Initials': 'TB', 'LastName': 'Neilands', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Judith T', 'Initials': 'JT', 'LastName': 'Moskowitz', 'Affiliation': 'Department of Medicine Social Sciences.'}, {'ForeName': 'Annesa', 'Initials': 'A', 'LastName': 'Flentje', 'Affiliation': 'Department of Community Health Systems.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000586'] 3077,33829803,Treating trauma and aggression with narrative exposure therapy in former child and adult soldiers: A randomized controlled trial in Eastern DR Congo.,"OBJECTIVE Individuals who return from armed groups present with a history of traumatic events including perpetration. Subsequent severe mental stress and heightened levels of reactive and appetitive aggression may persist and if left untreated, frequently impede peacebuilding and societal stability. In this study, we tested a revised adaptation of Narrative Exposure Therapy (NET; Schauer et al., 2011) for Forensic Offender Rehabilitation (FORNET) implemented in a sample of male former combatants in war-torn regions of the DR Congo. METHOD We applied a longitudinal parallel-group randomized controlled design with treatment as usual (TAU) as control condition and 3-5 and 6-9 months follow-up assessments. The effect of treatment over time on clinical and social outcomes was tested with GLMMs; appetitive aggression and current violent behavior (CVB) were specified as primary and posttraumatic stress as secondary outcomes. RESULTS FORNET decreased appetitive aggression (within group Cohen's d z = 2.00), CVB (d z = .90) and posttraumatic stress (d z = 1.48) significantly more than treatment as usual. Clinical significance was obtained for all outcomes. Remarkably, NET clients also reduced their substance abuse (dz = .68) even though this was not targeted within the intervention. Depression, perceived social acknowledgement and subjective solidarity with (para)military life decreased. CONCLUSION FORNET is a compact and scalable psychotherapeutic intervention that effectively reduces current aggressive behavior including physical abuse against children, intimate partner violence (IPV), and community violence. FORNET further decreases appetitive aggression, posttraumatic stress symptoms, and other clinical and social problems that commonly hinder demobilization, reintegration, and post-conflict peacebuilding. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"CONCLUSION FORNET is a compact and scalable psychotherapeutic intervention that effectively reduces current aggressive behavior including physical abuse against children, intimate partner violence (IPV), and community violence.","['former child and adult soldiers', 'Individuals who return from armed groups present with a history of traumatic events including perpetration', '2011) for Forensic Offender Rehabilitation (FORNET) implemented in a sample of male former combatants in war-torn regions of the DR Congo']","['Narrative Exposure Therapy (NET', 'narrative exposure therapy']","['appetitive aggression, posttraumatic stress symptoms', 'Depression, perceived social acknowledgement and subjective solidarity with (para)military life decreased', 'substance abuse', 'CVB ', 'posttraumatic stress', 'appetitive aggression']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0524647', 'cui_str': 'Soldiers'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C4751223', 'cui_str': 'Traumatic event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0016557', 'cui_str': 'Medicine, Forensic'}, {'cui': 'C0699726', 'cui_str': 'Offenders'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043027', 'cui_str': 'War'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0009738', 'cui_str': 'Congo'}]","[{'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]","[{'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0740858', 'cui_str': 'Substance abuse'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0424323', 'cui_str': 'Physical aggression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",,0.0362039,"CONCLUSION FORNET is a compact and scalable psychotherapeutic intervention that effectively reduces current aggressive behavior including physical abuse against children, intimate partner violence (IPV), and community violence.","[{'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Koebach', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Carleial', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Elbert', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schmitt', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Robjant', 'Affiliation': 'Department of Psychology.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000632'] 3078,33828741,"The Effect of Target Speed and Verbal Instruction on NPC Measures in a Young, Healthy, and Active Population.","Purpose: Evaluate the effect of target speed and verbal instruction on near point of convergence (NPC) measurements in a young, healthy, and active population. Methods : NPC was measured in 20 individuals with three target speeds and two sets of verbal instruction. The target speeds used were 1 cm/s, 3 cm/s, 5 cm/s, and participant self-paced. The verbal instruction given was either to indicate when the target became ""double"" or ""blurry"". Results : Paired-samples t-tests revealed significant differences between 5 cm/s (5.44 ± 2.01) and 1 cm/s (6.72 ± 2.39, p = .003), 3 cm/s (6.10 ± 2.36, p = .030) and self-paced (6.63 ± 2.26, p = .005). A significant difference ( p < .001) was also found between the ""double"" (6.72 ± 2.39) and ""blurry"" (10.82 ± 3.08) conditions. Conclusion : For young, healthy and active individuals, target speed and verbal instruction matter when measuring NPC.",2019,"Paired-samples t-tests revealed significant differences between 5 cm/s (5.44 ± 2.01) and 1 cm/s (6.72 ± 2.39, p = .003), 3 cm/s (6.10 ± 2.36, p = .030) and self-paced (6.63 ± 2.26, p = .005).","['a Young, Healthy, and Active Population', 'a young, healthy, and active population', '20 individuals with three target speeds and two sets of verbal instruction']","['Target Speed and Verbal Instruction', 'target speed and verbal instruction']",[],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]",[],20.0,0.0822297,"Paired-samples t-tests revealed significant differences between 5 cm/s (5.44 ± 2.01) and 1 cm/s (6.72 ± 2.39, p = .003), 3 cm/s (6.10 ± 2.36, p = .030) and self-paced (6.63 ± 2.26, p = .005).","[{'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'McGinnis', 'Affiliation': 'Temple University , Philadelphia, PA, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Tierney', 'Affiliation': 'Temple University , Philadelphia, PA, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Mansell', 'Affiliation': 'Temple University , Philadelphia, PA, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Phillips', 'Affiliation': 'Temple University , Philadelphia, PA, USA.'}]",Journal of eye movement research,['10.16910/jemr.12.4.5'] 3079,33828709,Microsaccadic rate signatures correlate under monocular and binocular stimulation conditions.,"Microsaccades are involuntary eye movements occurring naturally during fixation. In this study, microsaccades were investigated under monocularly and binocularly stimulated conditions with respect to their directional distribution and rate signature, that refers to a curve reporting the frequency modulation of microsaccades over time. For monocular stimulation the left eye was covered by an infrared filter. In both stimulation conditions, participants fixated a Gabor patch presented randomly in orientation of 45° or 135° over a wide range of spatial frequencies appearing in the center of a monitor. Considering the microsaccadic directions, this study showed microsaccades to be preferably horizontally oriented in their mean direction, regardless of the spatial characteristics of the grating. Furthermore, this outcome was found to be consistent between both stimulation conditions. Moreover, this study found that the microsaccadic rate signature curve correlates between both stimulation conditions, while the curve given for binocular stimulation was already proposed as a tool for estimation of visual performance in the past. Therefore, this study extends the applicability of microsaccades to clinical use, since parameters as contrast sensitivity, has been measured monocularly in the clinical attitude.",2020,"In this study, microsaccades were investigated under monocularly and binocularly stimulated conditions with respect to their directional distribution and rate signature, that refers to a curve reporting the frequency modulation of microsaccades over time.",[],[],[],[],[],[],,0.073048,"In this study, microsaccades were investigated under monocularly and binocularly stimulated conditions with respect to their directional distribution and rate signature, that refers to a curve reporting the frequency modulation of microsaccades over time.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Essig', 'Affiliation': 'Institute for Ophthalmic Research, Eberhard Karls University Tuebingen, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Leube', 'Affiliation': ''}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Rifai', 'Affiliation': ''}, {'ForeName': 'Siegfried', 'Initials': 'S', 'LastName': 'Wahl', 'Affiliation': ''}]",Journal of eye movement research,['10.16910/jemr.13.5.3'] 3080,33828687,Cross-modal music integration in expert memory: Evidence from eye movements.,"The study investigated the cross-modal integration hypothesis for expert musicians using eye tracking. Twenty randomized excerpts of classical music were presented in two modes (auditory and visual), at the same time (simultaneously) or successively (sequentially). Musicians (N = 53, 26 experts and 27 non-experts) were asked to detect a note modified between the auditory and visual versions, either in the same major/minor key or violating the key. Experts carried out the task faster and with greater accuracy than non-experts. Sequential presentation was more difficult than simultaneous (longer fixations and higher error rates) and the modified notes were more easily detected when violating the key (fewer errors), but with longer fixations (speed/accuracy trade-off strategy). Experts detected the modified note faster, especially in the simultaneous condition in which cross-modal integration may be applied. These results support the hypothesis that the main difference between experts and non-experts derives from the difference in knowledge structures in memory built over time with practice. They also suggest that these high-level knowledge structures in memory contain harmony and tonal rules, arguing in favour of cross-modal integration capacities for experts, which are related to and can be explained by the long-term working memory (LTWM) model of expert memory (e.g. (18; 22).",2018,"Sequential presentation was more difficult than simultaneous (longer fixations and higher error rates) and the modified notes were more easily detected when violating the key (fewer errors), but with longer fixations (speed/accuracy trade-off strategy).",[],['classical music'],[],[],"[{'cui': 'C0681251', 'cui_str': 'Classical Music'}]",[],,0.0293868,"Sequential presentation was more difficult than simultaneous (longer fixations and higher error rates) and the modified notes were more easily detected when violating the key (fewer errors), but with longer fixations (speed/accuracy trade-off strategy).","[{'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Drai-Zerbib', 'Affiliation': 'LEAD, University of Bourgogne Dijon, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Baccino', 'Affiliation': 'LEAD, University of Bourgogne Dijon, France.'}]",Journal of eye movement research,['10.16910/jemr.11.2.4'] 3081,33828613,Does Medication Sampling Improve Compliance with Brief Advice? Results from a Pragmatic Randomized Clinical Trial.,"Introduction The 5As model is a standard component of most guidelines for tobacco treatment. Unfortunately, provider adherence to this model is modest. Aims Providing physicians with adjunctive tools to adhere to 5As guidelines may serve as a catalyst for brief advice delivery. Methods This was a secondary data analysis of a cluster randomized clinical trial assessing the uptake and impact of free nicotine replacement therapy (NRT) sampling versus standard care in primary care. Patients reported receipt of separate elements of the 5As model, assessed one month following a baseline visit. Analyses compared patients who recalled receipt of brief advice among those who received NRT vs. standard care. Additional analyses examined demographic predictors of receiving brief advice. Results/Findings Medication sampling did not improve compliance with ask, advise, or assess. Receipt of ""assistance"" was significantly higher among NRT recipients (70%) ( p ≤ 0.0001). The NRT sampling group was more likely to have received all components ( p = 0.004). As age increased, being asked ( p = 0.006), advised ( p = 0.05), and assessed ( p = 0.003) decreased. Non-Whites reported higher rates of assessment ( p = 0.02). Conclusions Provision of NRT sampling increased provider compliance with some elements of the brief advice model, thus enhancing the impact of cessation advice within primary care. Trial Registration This trial is registered with ClinicalTrials.gov NCT02096029.",2021,"Receipt of ""assistance"" was significantly higher among NRT recipients (70%) ( p ≤ 0.0001).",['primary care'],"['nicotine replacement therapy (NRT) sampling versus standard care', 'NRT']","['Receipt of ""assistance']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]",,0.273754,"Receipt of ""assistance"" was significantly higher among NRT recipients (70%) ( p ≤ 0.0001).","[{'ForeName': 'Nathaniel J', 'Initials': 'NJ', 'LastName': 'Silvestri', 'Affiliation': 'College of Medicine, Medical University of South Carolina (MUSC), USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Dahne', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, MUSC, USA.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Wahlquist', 'Affiliation': 'Hollings Cancer Center, MUSC, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Toll', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, MUSC, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, MUSC, USA.'}]",Journal of smoking cessation,['10.1155/2021/6638872'] 3082,33828607,"The effect of azoximer bromide (Polyoxidonium®) in patients hospitalized with coronavirus disease (COVID-19): an open-label, multicentre, interventional clinical study.","A clinical need for aetiotropic coronavirus disease (COVID-19) treatments is required. The immune modulator azoximer bromide (AZB; Polyoxidonium®) is indicated in Russia for use against acute viral infections and during remission. In this study, adults hospitalized with COVID-19 ( n =32) received AZB and standard of care in an open-label, multicentre, interventional study. All patients were symptomatic; 22 had severe disease (National Early Warning Score ≥5) and required mechanical ventilation or oxygen saturation (SpO 2 ) and 19 patients had co-morbidities. Patients received AZB 12 mg intravenously once daily for 3 days, then intramuscularly every other day (approximately ten injections) until discharge. The primary endpoint was the patient's clinical status (7-point Ordinal Scale; OS) on day 15 versus that at baseline. The mean duration of hospitalization was 20 days. All patients were alive and discharged with normal SpO 2 with no secondary infections or delayed mortality reported by the end-of-study visit (on day 28-72). A decrease in the mean OS and National Early Warning Score values was observed following treatment with AZB. A decrease in OS score was marked in patients identified as severe. Both sets of patients achieved similar scores, which can be classified as an improvement by day 9-10; SpO 2 levels trended to normalization over time. By day 11-12, all patients had a normal body temperature. Serum C-reactive protein levels decreased in patients with severe and mild disease. Most patients had signs of pneumonia at baseline ( n =27), with the majority recovering by days 10-12. No major toxicities were observed. AZB was safe and well tolerated when administered in addition to standard of care treatment for COVID-19. Further randomized, placebo-controlled studies are needed to elucidate any potential therapeutic effect in COVID-19.",2021,All patients were alive and discharged with normal SpO 2 with no secondary infections or delayed mortality reported by the end-of-study visit (on day 28-72).,"['adults hospitalized with COVID-19 ( n =32) received', 'patients with severe and mild disease', 'All patients were symptomatic; 22 had severe disease (National Early Warning Score ≥5) and required mechanical ventilation or oxygen saturation (SpO 2 ) and 19 patients had co-morbidities', 'patients hospitalized with coronavirus disease (COVID-19']","['azoximer bromide (Polyoxidonium®', 'placebo', 'azoximer bromide (AZB; Polyoxidonium®', 'AZB', 'AZB and standard of care in an open-label']","['delayed mortality', 'Serum C-reactive protein levels', 'signs of pneumonia', ""patient's clinical status (7-point Ordinal Scale; OS"", 'major toxicities', 'mean OS and National Early Warning Score values', 'normal body temperature', 'OS score', 'safe and well tolerated', 'mean duration of hospitalization']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C5197888', 'cui_str': 'Early Warning Score'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0006222', 'cui_str': 'bromides'}, {'cui': 'C2716079', 'cui_str': 'Polyoxidonium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1277266', 'cui_str': 'Serum C reactive protein level'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C5197888', 'cui_str': 'Early Warning Score'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0231262', 'cui_str': 'Temperature normal'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",,0.0718474,All patients were alive and discharged with normal SpO 2 with no secondary infections or delayed mortality reported by the end-of-study visit (on day 28-72).,"[{'ForeName': 'Sergey V', 'Initials': 'SV', 'LastName': 'Efimov', 'Affiliation': ""State-Funded Healthcare Institution 'Emergency Hospital' of Ministry of Health of Chuvash Republic, Chuvash Republic, Cheboksary, Russia.""}, {'ForeName': 'Natallia V', 'Initials': 'NV', 'LastName': 'Matsiyeuskaya', 'Affiliation': ""Healthcare Institution 'Grodno Regional Infectious Clinical Hospital', Grodno, Belarus.""}, {'ForeName': 'Olga V', 'Initials': 'OV', 'LastName': 'Boytsova', 'Affiliation': ""State-Funded Healthcare Institution 'Infectious Disease Hospital No.3' of Ministry of Health of Krasnodar Krai, Krasnodar Krai, Novorossiysk, Russia.""}, {'ForeName': 'Lyudmila Yu', 'Initials': 'LY', 'LastName': 'Akhieva', 'Affiliation': ""State-Funded Institution of Mari El Republic 'Ioshkar-Ola City Hospital', Mari El Republic, Ioshkar Ola, Russia.""}, {'ForeName': 'Elena I', 'Initials': 'EI', 'LastName': 'Kvasova', 'Affiliation': ""State-Funded Healthcare Institution of Voronezh Region 'Novaya Usman District Hospital', Voronezh Region, Novaya Usman, Russia.""}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Harrison', 'Affiliation': 'IDEA Regulatory, London, UK.'}, {'ForeName': 'Yulia S', 'Initials': 'YS', 'LastName': 'Karpova', 'Affiliation': 'NPO Petrovax Pharm LLC, Moscow, Russia.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Tikhonov', 'Affiliation': 'NPO Petrovax Pharm LLC, Moscow, Russia.'}, {'ForeName': 'Nadezhda F', 'Initials': 'NF', 'LastName': 'Khomyakova', 'Affiliation': 'NPO Petrovax Pharm LLC, Moscow, Russia.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Hardman', 'Affiliation': 'Niche Science & Technology, Richmond, UK.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Rossi', 'Affiliation': 'Institut Sainte Catherine, Avignon, France.'}]",Drugs in context,['10.7573/dic.2020-11-1'] 3083,33828601,Comparison of intravenous sodium bicarbonate and sodium chloride combination versus intravenous sodium chloride hydration alone in reducing amphotericin B nephrotoxicity: a randomized clinical trial.,"Background and purpose The most important adverse reaction of amphotericin B (AmB) is nephrotoxicity. The aim of this study was to assess the potential effectiveness of intravenous saline + sodium bicarbonate versus intravenous sodium chloride hydration in preventing or attenuating AmB nephrotoxicity. Experimental approach A randomized, non-placebo-controlled, single-blinded clinical trial was conducted in two adult hematology-oncology wards of Namazi hospital. Eligible patients were randomly assigned into either the normal saline or normal saline + sodium bicarbonate groups by the ratio of 1:2. In the normal saline group, 1000 mL of sodium chloride 0.9% (154 meq sodium) was given intravenously as two equal 500 mL volumes before and during the infusion of AmB. Patients in the saline + sodium bicarbonate group received 500 mL sodium chloride 0.9% (72 meq sodium) before and 500 mL isotonic sodium bicarbonate (72 meq sodium) intravenously during AmB infusion. Findings/Results The rate of AmB nephrotoxicity was comparable between normal saline and sodium bicarbonate groups (54.2% and 41.6%, respectively; P = 0.3). This difference did not reach the level of statistical significance after considering AmB dose and duration of the treatment. The frequency of hypokalemia and hypomagnesemia did not differ significantly between the two groups even after adjusting the results according to AmB dose and treatment duration. Conclusion and implications The results of the current preliminary clinical trial suggested that the combination of sodium bicarbonate and normal saline compared to normal saline alone appears to have no superiority in preventing or attenuating different studied aspects of AmB nephrotoxicity in patients with hematological malignancies.",2020,"The rate of AmB nephrotoxicity was comparable between normal saline and sodium bicarbonate groups (54.2% and 41.6%, respectively; P = 0.3).","['Eligible patients', 'two adult hematology-oncology wards of Namazi hospital', 'patients with hematological malignancies']","['sodium chloride 0.9% (154 meq sodium', 'placebo', 'sodium bicarbonate', 'saline + sodium bicarbonate group received 500 mL sodium chloride 0.9% (72 meq sodium) before and 500 mL isotonic sodium bicarbonate', 'normal saline or normal saline + sodium bicarbonate', 'amphotericin B (AmB', 'sodium bicarbonate and normal saline', 'intravenous sodium bicarbonate and sodium chloride combination versus intravenous sodium chloride hydration alone', 'intravenous saline + sodium bicarbonate versus intravenous sodium chloride hydration']","['rate of AmB nephrotoxicity', 'amphotericin B nephrotoxicity', 'frequency of hypokalemia and hypomagnesemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5191638', 'cui_str': 'Adult hematology'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0439152', 'cui_str': 'mEq'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0002679', 'cui_str': 'Amphotericin B'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}]","[{'cui': 'C0002679', 'cui_str': 'Amphotericin B'}, {'cui': 'C0595916', 'cui_str': 'Toxic nephropathy'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0151723', 'cui_str': 'Hypomagnesemia'}]",,0.235179,"The rate of AmB nephrotoxicity was comparable between normal saline and sodium bicarbonate groups (54.2% and 41.6%, respectively; P = 0.3).","[{'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'Karimzadeh', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shiraz University of Medical Science, Shiraz, I.R. Iran.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Sepehr-Sobhani', 'Affiliation': 'Department of Pharmacology-Toxicology, School of Pharmacy, Shiraz University of Medical Science, Shiraz, I.R. Iran.'}, {'ForeName': 'Mohammad Javad', 'Initials': 'MJ', 'LastName': 'Khoshnoud', 'Affiliation': 'Department of Pharmacology-Toxicology, School of Pharmacy, Shiraz University of Medical Science, Shiraz, I.R. Iran.'}, {'ForeName': 'Mohammad Mahdi', 'Initials': 'MM', 'LastName': 'Sagheb', 'Affiliation': 'Nephrology-Urology Research Center and Department of Internal Medicine, Shiraz University of Medical Sciences, Shiraz, I.R. Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Vejdani', 'Affiliation': 'Hematology Research Center and Department of Internal Medicine, Shiraz University of Medical Sciences, Shiraz, I.R. Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Jalali', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shiraz University of Medical Science, Shiraz, I.R. Iran.'}, {'ForeName': 'Motahareh', 'Initials': 'M', 'LastName': 'Mahi-Birjand', 'Affiliation': 'Infectious Diseases Research Center, Birjand University of Medical Sciences, Birjand, I.R. Iran.'}]",Research in pharmaceutical sciences,['10.4103/1735-5362.301343'] 3084,33827126,Effects of Remifentanil on Cardiovascular Stimulation Caused by Local Anesthetic With Epinephrine: A Power Spectral Analysis.,"The objectives of this research were to investigate (a) what was the most effective infusion rate of remifentanil and (b) the degree to which sympathomimetic effects were involved with cardiovascular stimulation by using a power spectral analysis of heart rate variability (HRV). A total of 63 healthy individuals scheduled for sagittal split ramus osteotomy were enrolled and randomly allocated to 1 of 3 groups: remifentanil infusion rate of 0.1, 0.2, or 0.4 μg/kg/min. Anesthesia was maintained with remifentanil and propofol. Before the surgical procedure, 2% lidocaine containing 12.5 μg/mL epinephrine was administered in the surgical field for local anesthesia. Systolic blood pressure (SBP), heart rate (HR), low-frequency (LF) and high-frequency (HF) components in HRV power spectral analysis, and the LF/HF ratio were analyzed. Increases in SBP and HR were observed after local anesthesia in all 3 groups, but no significant differences were observed between the groups. Remifentanil infusion at 0.1 μg/kg/min may be appropriate to minimize cardiovascular stimulation caused by exogenous epinephrine from local anesthesia. Although a rise in the LF/HF ratio was observed after local anesthesia in all groups, no relationship was observed between the cardiovascular changes and the increase in LF/HF ratio. This suggests that sympathomimetic effects are involved to a lesser extent with the cardiovascular stimulation caused by exogenous epinephrine.",2020,"Increases in SBP and HR were observed after local anesthesia in all 3 groups, but no significant differences were observed between the groups.",['63 healthy individuals scheduled for sagittal split ramus osteotomy'],"['remifentanil', 'Epinephrine', 'Remifentanil', 'lidocaine', 'remifentanil and propofol', 'epinephrine']","['Systolic blood pressure (SBP), heart rate (HR), low-frequency (LF) and high-frequency (HF) components in HRV power spectral analysis, and the LF/HF ratio', 'SBP and HR', 'Cardiovascular Stimulation', 'LF/HF ratio']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C3178772', 'cui_str': 'Sagittal Split Ramus Osteotomy'}]","[{'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]",63.0,0.024414,"Increases in SBP and HR were observed after local anesthesia in all 3 groups, but no significant differences were observed between the groups.","[{'ForeName': 'Asako', 'Initials': 'A', 'LastName': 'Eriguchi', 'Affiliation': ''}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Matsuura', 'Affiliation': 'Associate Professor.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Koukita', 'Affiliation': 'Visiting Professor.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Ichinohe', 'Affiliation': 'Professor and Chairman, Department of Dental Anesthesiology, Tokyo Dental College, Tokyo, Japan.'}]",Anesthesia progress,['10.2344/anpr-67-03-10'] 3085,33826861,"Executive Functioning, Depressive Symptoms, and Intervention Engagement in a Sample of Adolescents Enrolled in a Weight Management Program.","Purpose: This study examines how baseline demographics, psychosocial characteristics, and intervention delivery predict engagement among adolescents with overweight and obesity seeking treatment. Methods: Data originates from a multisite randomized control trial evaluating the efficacy of an app-based weight loss intervention, compared with standard in-clinic model in adolescents with overweight and obesity. Participants were randomized to one of the three arms: (1) AppCoach, (2) AppAlone, or (3) Control. Demographic, executive functioning (EF), and depression questionnaires were completed at baseline. Percent engagement was compared within and between groups defined by demographics and depressive symptoms. Quantile regression was used to evaluate the association between age and EF on percent engagement. Results: Baseline demographics were not associated with engagement within or between groups. Neither baseline self-reported depressive symptoms ( p  = 0.244) nor deficits in EF ( p  = 0.34) were predictors of engagement. Univariate analysis found that the control arm had the highest engagement (83%) compared with AppCoach (63.5%) and AppAlone (22.5%, p  = 0.02). Hispanic ethnicity was predictive of higher engagement in the control arm ( p  = 0.02). On multivariate quartile regression no other baseline characteristics were significant predictors of engagement. Conclusion: Baseline demographics and individual psychosocial characteristics were not related to engagement in this cohort. The intervention arm that required parental involvement resulted in the greatest engagement suggesting that family involvement may overshadow individual behavioral phenotype and thus promote better engagement. Further investigation is needed to understand how program delivery can be leveraged to optimize treatment engagement and outcomes in adolescence. Clinical Trial Registration number: NCT03500835.",2021,"Univariate analysis found that the control arm had the highest engagement (83%) compared with AppCoach (63.5%) and AppAlone (22.5%, p  = 0.02).","['adolescents with overweight and obesity seeking treatment', 'adolescents with overweight and obesity', 'Adolescents Enrolled in a Weight Management Program']","['AppCoach, (2) AppAlone, or (3) Control', 'app-based weight loss intervention']","['depressive symptoms', 'Demographic, executive functioning (EF), and depression questionnaires', 'Executive Functioning, Depressive Symptoms, and Intervention Engagement']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]",,0.158862,"Univariate analysis found that the control arm had the highest engagement (83%) compared with AppCoach (63.5%) and AppAlone (22.5%, p  = 0.02).","[{'ForeName': 'Kelleen E', 'Initials': 'KE', 'LastName': 'Lopez', 'Affiliation': ""Diabetes and Obesity Program, Center for Endocrinology, Diabetes, and Metabolism, Children's Hospital Los Angeles, Los Angeles, CA, USA.""}, {'ForeName': 'Sarah-Jeanne', 'Initials': 'SJ', 'LastName': 'Salvy', 'Affiliation': 'Research Center for Health Equity, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Fink', 'Affiliation': ""Diabetes and Obesity Program, Center for Endocrinology, Diabetes, and Metabolism, Children's Hospital Los Angeles, Los Angeles, CA, USA.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Werner', 'Affiliation': ""Institute for Nursing and Interprofessional Research, Children's Hospital Los Angeles, Los Angeles, CA, USA.""}, {'ForeName': 'Choo Phei', 'Initials': 'CP', 'LastName': 'Wee', 'Affiliation': 'Department of Preventive Medicine, Southern California Clinical and Translational Science Institute, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hegedus', 'Affiliation': ""Diabetes and Obesity Program, Center for Endocrinology, Diabetes, and Metabolism, Children's Hospital Los Angeles, Los Angeles, CA, USA.""}, {'ForeName': 'Janelle', 'Initials': 'J', 'LastName': 'Gonzalez', 'Affiliation': ""Diabetes and Obesity Program, Center for Endocrinology, Diabetes, and Metabolism, Children's Hospital Los Angeles, Los Angeles, CA, USA.""}, {'ForeName': 'D Steven', 'Initials': 'DS', 'LastName': 'Fox', 'Affiliation': 'Department of Pharmaceutical and Health Economics, School of Pharmacy of the University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Alaina P', 'Initials': 'AP', 'LastName': 'Vidmar', 'Affiliation': ""Diabetes and Obesity Program, Center for Endocrinology, Diabetes, and Metabolism, Children's Hospital Los Angeles, Los Angeles, CA, USA.""}]",Childhood obesity (Print),['10.1089/chi.2020.0334'] 3086,33826614,Identifying treatment options for BRAFV600 wild-type metastatic melanoma: A SU2C/MRA genomics-enabled clinical trial.,"Although combination BRAF and MEK inhibitors are highly effective for the 40-50% of cutaneous metastatic melanomas harboring BRAFV600 mutations, targeted agents have been ineffective for BRAFV600wild-type (wt) metastatic melanomas. The SU2C Genomics-Enabled Medicine for Melanoma Trial utilized a Simon two-stage optimal design to assess whether comprehensive genomic profiling improves selection of molecular-based therapies for BRAFV600wt metastatic melanoma patients who had progressed on standard-of-care therapy, which may include immunotherapy. Of the response-evaluable patients, binimetinib was selected for 20 patients randomized to the genomics-enabled arm, and nine were treated on the alternate treatment arm. Response rates for 27 patients treated with targeted recommendations included one (4%) partial response, 18 (67%) with stable disease, and eight (30%) with progressive disease. Post-trial genomic and protein pathway activation mapping identified additional drug classes that may be considered for future studies. Our results highlight the complexity and heterogeneity of metastatic melanomas, as well as how the lack of response in this trial may be associated with limitations including monotherapy drug selection and the dearth of available single and combination molecularly-driven therapies to treat BRAFV600wt metastatic melanomas.",2021,"Response rates for 27 patients treated with targeted recommendations included one (4%) partial response, 18 (67%) with stable disease, and eight (30%) with progressive disease.","['BRAFV600 wild-type metastatic melanoma', '27 patients treated with targeted recommendations included one (4%) partial response, 18 (67%) with stable disease, and eight (30%) with progressive disease', 'BRAFV600wt metastatic melanoma patients who had progressed on standard-of-care therapy']",[],['Response rates'],"[{'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],[],20.0,0.229501,"Response rates for 27 patients treated with targeted recommendations included one (4%) partial response, 18 (67%) with stable disease, and eight (30%) with progressive disease.","[{'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'LoRusso', 'Affiliation': 'Yale Cancer Center, Yale University, New Haven, CT, United States of America.'}, {'ForeName': 'Aleksandar', 'Initials': 'A', 'LastName': 'Sekulic', 'Affiliation': 'Mayo Clinic, Scottsdale, AZ, United States of America.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Sosman', 'Affiliation': 'Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Evanston, IL, United States of America.'}, {'ForeName': 'Winnie S', 'Initials': 'WS', 'LastName': 'Liang', 'Affiliation': 'Translational Genomics Research Institute, Phoenix, AZ, United States of America.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Carpten', 'Affiliation': 'Keck School of Medicine, University of Southern California, Los Angeles, CA, United States of America.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Craig', 'Affiliation': 'Keck School of Medicine, University of Southern California, Los Angeles, CA, United States of America.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Solit', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, United States of America.'}, {'ForeName': 'Alan H', 'Initials': 'AH', 'LastName': 'Bryce', 'Affiliation': 'Mayo Clinic, Scottsdale, AZ, United States of America.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Kiefer', 'Affiliation': 'Translational Genomics Research Institute, Phoenix, AZ, United States of America.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Aldrich', 'Affiliation': 'Translational Genomics Research Institute, Phoenix, AZ, United States of America.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Nasser', 'Affiliation': 'Translational Genomics Research Institute, Phoenix, AZ, United States of America.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Halperin', 'Affiliation': 'Translational Genomics Research Institute, Phoenix, AZ, United States of America.'}, {'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Byron', 'Affiliation': 'Translational Genomics Research Institute, Phoenix, AZ, United States of America.'}, {'ForeName': 'Mary Jo', 'Initials': 'MJ', 'LastName': 'Pilat', 'Affiliation': 'Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University, Detroit, MI, United States of America.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Boerner', 'Affiliation': 'Yale Cancer Center, Yale University, New Haven, CT, United States of America.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Durecki', 'Affiliation': 'Yale Cancer Center, Yale University, New Haven, CT, United States of America.'}, {'ForeName': 'William P D', 'Initials': 'WPD', 'LastName': 'Hendricks', 'Affiliation': 'Translational Genomics Research Institute, Phoenix, AZ, United States of America.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Enriquez', 'Affiliation': 'Translational Genomics Research Institute, Phoenix, AZ, United States of America.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Izatt', 'Affiliation': 'Translational Genomics Research Institute, Phoenix, AZ, United States of America.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Keats', 'Affiliation': 'Translational Genomics Research Institute, Phoenix, AZ, United States of America.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Legendre', 'Affiliation': 'Translational Genomics Research Institute, Phoenix, AZ, United States of America.'}, {'ForeName': 'Svetomir N', 'Initials': 'SN', 'LastName': 'Markovic', 'Affiliation': 'Mayo Clinic, Rochester, MN, United States of America.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Weise', 'Affiliation': 'Barbara Ann Karmanos Cancer Institute, Wayne State University, Detroit, MI, United States of America.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Naveed', 'Affiliation': 'Translational Genomics Research Institute, Phoenix, AZ, United States of America.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Schmidt', 'Affiliation': 'Mayo Clinic, Scottsdale, AZ, United States of America.'}, {'ForeName': 'Gargi D', 'Initials': 'GD', 'LastName': 'Basu', 'Affiliation': 'Translational Genomics Research Institute, Phoenix, AZ, United States of America.'}, {'ForeName': 'Shobana', 'Initials': 'S', 'LastName': 'Sekar', 'Affiliation': 'Translational Genomics Research Institute, Phoenix, AZ, United States of America.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Adkins', 'Affiliation': 'Translational Genomics Research Institute, Phoenix, AZ, United States of America.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Tassone', 'Affiliation': 'Translational Genomics Research Institute, Phoenix, AZ, United States of America.'}, {'ForeName': 'Karthigayini', 'Initials': 'K', 'LastName': 'Sivaprakasam', 'Affiliation': 'Translational Genomics Research Institute, Phoenix, AZ, United States of America.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Zismann', 'Affiliation': 'Translational Genomics Research Institute, Phoenix, AZ, United States of America.'}, {'ForeName': 'Valerie S', 'Initials': 'VS', 'LastName': 'Calvert', 'Affiliation': 'Center for Applied Proteomics and Molecular Medicine, George Mason University, Manassas, VA, United States of America.'}, {'ForeName': 'Emanuel F', 'Initials': 'EF', 'LastName': 'Petricoin', 'Affiliation': 'Center for Applied Proteomics and Molecular Medicine, George Mason University, Manassas, VA, United States of America.'}, {'ForeName': 'Leslie Anne', 'Initials': 'LA', 'LastName': 'Fecher', 'Affiliation': 'University of Michigan Comprehensive Cancer Center, University of Michigan, Ann Arbor, MI, United States of America.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lao', 'Affiliation': 'University of Michigan Comprehensive Cancer Center, University of Michigan, Ann Arbor, MI, United States of America.'}, {'ForeName': 'J Paul', 'Initials': 'JP', 'LastName': 'Eder', 'Affiliation': 'Yale Cancer Center, Yale University, New Haven, CT, United States of America.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Vogelzang', 'Affiliation': 'US Oncology, United States of America.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Perlmutter', 'Affiliation': 'Gemini Group, Ann Arbor, MI, United States of America.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Gorman', 'Affiliation': 'Silver Spring, MD, United States of America.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Manica', 'Affiliation': 'Barbara Ann Karmanos Cancer Institute, Wayne State University, Detroit, MI, United States of America.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Fox', 'Affiliation': 'Yale Cancer Center, Yale University, New Haven, CT, United States of America.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Schork', 'Affiliation': 'Translational Genomics Research Institute, Phoenix, AZ, United States of America.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Zelterman', 'Affiliation': 'Yale Cancer Center, Yale University, New Haven, CT, United States of America.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'DeVeaux', 'Affiliation': 'Yale Cancer Center, Yale University, New Haven, CT, United States of America.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Joseph', 'Affiliation': 'Mayo Clinic, Jacksonville, FL, United States of America.'}, {'ForeName': 'C Lance', 'Initials': 'CL', 'LastName': 'Cowey', 'Affiliation': 'Charles A. Sammons Cancer Center/Baylor University Medical Center, Dallas, TX, United States of America.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Trent', 'Affiliation': 'Translational Genomics Research Institute, Phoenix, AZ, United States of America.'}]",PloS one,['10.1371/journal.pone.0248097'] 3087,33826591,Complications and Revision Rates in Minimally Invasive Robotic-Guided Versus Fluoroscopic-Guided Spinal Fusions: The MIS ReFRESH Prospective Comparative Study.,"STUDY DESIGN Prospective, multi-center, partially randomized. OBJECTIVE Assess rates of complications, revision surgery, and radiation between Mazor robotic-guidance (RG) and fluoro-guidance (FG). SUMMARY OF BACKGROUND DATA MIS ReFRESH is the first study designed to compare RG and FG techniques in adult MIS lumbar fusions. METHODS Primary endpoints were analyzed at 1 year follow-up. Analysis of variables through Cox logistic regression and a Kaplan-Meier Survival Curve of surgical complications. RESULTS 9 sites enrolled 485 patients: 374 (RG arm) and 111 (FG arm). 93.2% of patients had >1 year f/u. There were no differences for gender, Charlson Comorbidity Index, diabetes, or tumor. Mean age of RG patients was 59.0 vs. 62.5 for FG (p = 0.009) and BMI was 31.2 vs. 28.1 (p < 0.001). Percentage of smokers was almost double in the RG (15.2% vs. 7.2%, p = .029). Surgical time was similar (skin-to-skin time/#screws) at 24.9 min RG and 22.9 FG (p = 0.550). Fluoroscopy during surgery/#screws was 15.5 sec RG vs. 35.4 sec FG, (15 sec average reduction). Fluoroscopy time during instrumentation/#screws was 3.6 seconds RG vs. 17.8 seconds FG showing an 80% average reduction of fluoro time/screw in RG (p < 0.001). Within one year follow-up, there were 39 (10.4%) surgical complications RG vs. 39 (35.1%) FG, and 8 (2.1%) revisions RG vs. 7 (6.3%) FG. Cox regression analysis including age, gender, BMI, CCI and # screws, demonstrated that the Hazard Ratio (HR) for complication was 5.8 times higher FG vs. RG (95% CI: 3.5-9.6, p < 0.001). HR for revision surgery was 11.0 times higher FG vs. RG cases (95% CI 2.9-41.2, p < 0.001). CONCLUSIONS Mazor robotic-guidance was found to have a 5.8 times lower risk of a surgical complication and 11.0 times lower risk for revision surgery. Surgical time was similar between groups and robotic-guidance reduced fluoro time per screw by 80% (approximately one minute/case).Level of Evidence: 2.",2021,FG showing an 80% average reduction of fluoro time/screw in RG (p < 0.001).,"['adult MIS lumbar fusions', '9 sites enrolled 485 patients: 374 (RG arm) and 111 (FG arm']","['Minimally Invasive Robotic-Guided Versus Fluoroscopic-Guided Spinal Fusions', 'Mazor robotic-guidance (RG) and fluoro-guidance (FG']","['fluoro time per screw', 'Complications and Revision Rates', 'HR for revision surgery', 'BMI', 'Fluoroscopy time', 'Hazard Ratio (HR) for complication', 'Surgical time', 'fluoro time/screw in RG', 'gender, Charlson Comorbidity Index, diabetes, or tumor']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4517538', 'cui_str': '111'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0037935', 'cui_str': 'Spinal arthrodesis'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C4546361', 'cui_str': 'Charlson Comorbidity Index'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]",485.0,0.130207,FG showing an 80% average reduction of fluoro time/screw in RG (p < 0.001).,"[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Good', 'Affiliation': 'Virginia Spine Institute, Reston, VA National Spine Health Foundation, Reston, VA Tabor Orthopedics, Memphis, TN Lyerly Neurosurgery, Jacksonville, FL Atlantic Brain and Spine, Reston, VA Rothman Institute, Abington, PA Department of Orthopedic Surgery, Florida Hospital, Celebration, FL Central Florida Neurosurgery Institute, Osceola, FL Southeastern Spine Center & Research Institute, Sarasota, FL Department of Neurological Surgery, University of Miami Hospital, Miami, FL.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Orosz', 'Affiliation': ''}, {'ForeName': 'Samuel R', 'Initials': 'SR', 'LastName': 'Schroerlucke', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Cannestra', 'Affiliation': ''}, {'ForeName': 'Jae Y', 'Initials': 'JY', 'LastName': 'Lim', 'Affiliation': ''}, {'ForeName': 'Victor W', 'Initials': 'VW', 'LastName': 'Hsu', 'Affiliation': ''}, {'ForeName': 'Faissal', 'Initials': 'F', 'LastName': 'Zahrawi', 'Affiliation': ''}, {'ForeName': 'Hunaldo J', 'Initials': 'HJ', 'LastName': 'Villalobos', 'Affiliation': ''}, {'ForeName': 'Pedro M', 'Initials': 'PM', 'LastName': 'Ramirez', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Sweeney', 'Affiliation': ''}, {'ForeName': 'Michael Y', 'Initials': 'MY', 'LastName': 'Wang', 'Affiliation': ''}]",Spine,['10.1097/BRS.0000000000004048'] 3088,33835383,Treatment Satisfaction of Galcanezumab in Japanese Patients with Episodic Migraine: A Phase 2 Randomized Controlled Study.,"INTRODUCTION This analysis evaluated the treatment satisfaction of Japanese patients receiving galcanezumab (GMB) as a preventive medication for episodic migraine (4-14 monthly migraine headache days). METHODS This phase 2, randomized, double-blind, placebo-controlled study enrolled patients aged 18-65 years at 40 centers in Japan. Patients were randomized 2:1:1 to receive monthly subcutaneous injections of placebo (PBO, n = 230), GMB 120 mg (n = 115), or GMB 240 mg (n = 114) for 6 months. Patients' experience with treatment was measured using the Patient Global Impression of Severity (PGI-S), Patient Global Impression of Improvement (PGI-I), and Patient Satisfaction with Medication Questionnaire-Modified (PSMQ-M) scales. PGI-S was administered at baseline and months 1-6, PGI-I at months 1-6, and PSMQ-M at months 1 and 6. Prespecified analyses were differences between GMB and PBO in PGI-I and the change from baseline in PGI-S, and evaluating positive responses for the PGI-I and PSMQ-M. RESULTS Average change ± SE from baseline across months 1-6 was - 0.09 ± 0.05 (PBO), - 0.17 ± 0.07 (GMB 120 mg, p = 0.33), and - 0.30 ± 0.07 (GMB 240 mg, p = 0.013) for PGI-S. Average PGI-I across months 1-6 was 3.39 ± 0.05 (PBO), 2.55 ± 0.07 (GMB 120 mg, p < 0.05), and 2.71 ± 0.07 (GMB 240 mg, p < 0.05). Reductions of 2.8-3.0 monthly migraine headache days corresponded to 25-31% higher positive PGI-I response rates with GMB compared with PBO. Positive PSMQ-M response rates for satisfaction and preference were statistically significantly higher for GMB compared with PBO (odds ratio [95% confidence interval], all p < 0.05 vs. PBO): satisfaction GMB 120 mg (3.142 [1.936-5.098]) and GMB 240 mg (3.924 [2.417-6.369]), and preference GMB 120 mg (3.691 [2.265-6.017]) and GMB 240 mg (3.510 [2.180-5.652]). CONCLUSION Japanese patients with episodic migraine receiving preventive treatment with GMB are significantly more satisfied than those receiving PBO. TRIAL REGISTRATION ClinicalTrials.gov, NCT02959177 (registered November 7, 2016).",2021,"Positive PSMQ-M response rates for satisfaction and preference were statistically significantly higher for GMB compared with PBO (odds ratio [95% confidence interval], all p < 0.05 vs. PBO): satisfaction GMB 120 mg (3.142 [1.936-5.098]) and GMB 240 mg (3.924 [2.417-6.369]), and preference GMB 120 mg (3.691 [2.265-6.017]) and GMB 240 mg (3.510 [2.180-5.652]). ","['Japanese patients with episodic migraine', 'Japanese patients receiving', 'Japanese Patients with Episodic Migraine', 'enrolled patients aged 18-65\xa0years at 40 centers in Japan']","['galcanezumab (GMB', 'GMB', 'Galcanezumab', 'placebo', 'placebo (PBO, n\u2009=\u2009230), GMB 120\xa0mg (n\u2009=\u2009115), or GMB']","['Positive PSMQ-M response rates for satisfaction and preference', 'Patient Global Impression of Severity (PGI-S), Patient Global Impression of Improvement (PGI-I), and Patient Satisfaction with Medication Questionnaire-Modified (PSMQ-M) scales']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C4694273', 'cui_str': 'galcanezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4517540', 'cui_str': '115'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C4720882', 'cui_str': 'Patient global impression of severity'}, {'cui': 'C4706333', 'cui_str': 'Patient Global Impression of Improvement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.241959,"Positive PSMQ-M response rates for satisfaction and preference were statistically significantly higher for GMB compared with PBO (odds ratio [95% confidence interval], all p < 0.05 vs. PBO): satisfaction GMB 120 mg (3.142 [1.936-5.098]) and GMB 240 mg (3.924 [2.417-6.369]), and preference GMB 120 mg (3.691 [2.265-6.017]) and GMB 240 mg (3.510 [2.180-5.652]). ","[{'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Tatsuoka', 'Affiliation': 'Tatsuoka Neurology Clinic, Kyoto, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Takeshima', 'Affiliation': 'Department of Neurology, Headache Center, Tominaga Hospital, Osaka, Japan.'}, {'ForeName': 'Akichika', 'Initials': 'A', 'LastName': 'Ozeki', 'Affiliation': 'Eli Lilly Japan K.K., Kobe, Japan.'}, {'ForeName': 'Taka', 'Initials': 'T', 'LastName': 'Matsumura', 'Affiliation': 'Eli Lilly Japan K.K., Kobe, Japan. matsumura_taka@lilly.com.'}]",Neurology and therapy,['10.1007/s40120-021-00236-5'] 3089,33835354,A Pilot Randomized Controlled Trial of a Daily Living Skills Intervention for Adolescents with Autism.,"Adolescents with autism spectrum disorder (ASD) without an intellectual disability have daily living skills (DLS) impairments. An initial feasibility pilot of Surviving and Thriving in the Real World (STRW), a group intervention that targets DLS, demonstrated significant improvements. A pilot RCT of STRW was conducted to extend these findings. Twelve adolescents with ASD were randomized to the treatment or waitlist groups. The treatment group had significant DLS improvements on the Vineland Adaptive Behavior Scales, 3rd Edition and the DLS goal attainment scale. Four adolescents from the waitlist crossed over and completed STRW. Entire sample analyses with 10 participants demonstrated large DLS gains. Results provide further evidence of the efficacy of STRW for closing the gap between DLS and chronological age.",2021,"The treatment group had significant DLS improvements on the Vineland Adaptive Behavior Scales, 3rd Edition and the DLS goal attainment scale.","['Twelve adolescents with ASD', 'Adolescents with Autism', 'Adolescents with autism spectrum disorder (ASD) without an intellectual disability have daily living skills (DLS) impairments']",['Daily Living Skills Intervention'],"['large DLS gains', 'Vineland Adaptive Behavior Scales, 3rd Edition and the DLS goal attainment scale']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0582680', 'cui_str': 'Vineland adaptive behavior scales'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",12.0,0.120707,"The treatment group had significant DLS improvements on the Vineland Adaptive Behavior Scales, 3rd Edition and the DLS goal attainment scale.","[{'ForeName': 'Amie', 'Initials': 'A', 'LastName': 'Duncan', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Behavioral Medicine and Clinical Psychology, MLC 3015, Cincinnati, OH, 45229, USA. amie.duncan@cchmc.org.""}, {'ForeName': 'Jareen', 'Initials': 'J', 'LastName': 'Meinzen-Derr', 'Affiliation': ""Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, MLC 5041, Cincinnati, OH, 45229, USA.""}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Ruble', 'Affiliation': 'Teachers College, Ball State University, TC745, Muncie, IN, 47306, USA.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Fassler', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Behavioral Medicine and Clinical Psychology, MLC 3015, Cincinnati, OH, 45229, USA.""}, {'ForeName': 'Lori J', 'Initials': 'LJ', 'LastName': 'Stark', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Behavioral Medicine and Clinical Psychology, MLC 3015, Cincinnati, OH, 45229, USA.""}]",Journal of autism and developmental disorders,['10.1007/s10803-021-04993-y'] 3090,33835329,"Oral nutritional supplements versus a regular diet alone for body weight loss after gastrectomy: a phase 3, multicenter, open-label randomized controlled trial.","BACKGROUND Body weight loss (BWL) after gastrectomy is associated with not only a deteriorated quality of life but also a poor prognosis. Oral nutritional supplements (ONS) may be used to minimize BWL, which is observed in the first 3 months after gastrectomy and becomes stable thereafter, although the results of several randomized trials remain controversial. METHODS We performed a multicenter, open-label randomized controlled trial including 1003 gastric cancer patients undergoing curative gastrectomy. Patients were assigned to the ONS group or the control group. In the former, 400 ml (400 kcal) per day for 12 weeks as enteral nutrition was planned, and the actual intake amount was recorded daily by patients themselves. The primary endpoint was BWL 1 year after gastrectomy. RESULTS BWL data were available in 880 patients (ONS 437, control 443). BWL at 3 months was significantly lower in the ONS group than in the control group (7.1 ± 5.6% and 8.5 ± 5.8%, p = 0.0011). However, the difference gradually declined after 6 months and was not significant 1 year after surgery (9.3 ± 8.2% and 9.8 ± 8.7%, p = 0.37). In the ONS group, 50.4% of patients took more than 200 ml/day of ONS (average 301 ml) and showed significantly less BWL (8.2 ± 7.2%) at 1 year than the control (p = 0.0204). CONCLUSION The administration of ONS for 12 weeks after gastrectomy did not improve BWL at 1 year. However, the improvement in BWL remained until 1 year after surgery in patients who took more than 200 kcal/day of ONS.",2021,"BWL at 3 months was significantly lower in the ONS group than in the control group (7.1 ± 5.6% and 8.5 ± 5.8%, p = 0.0011).","['880 patients (ONS 437, control 443', '1003 gastric cancer patients undergoing curative gastrectomy']","['Oral nutritional supplements', 'regular diet alone', 'Oral nutritional supplements (ONS', 'ONS']","['BWL 1\xa0year after gastrectomy', 'BWL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}]",1003.0,0.100657,"BWL at 3 months was significantly lower in the ONS group than in the control group (7.1 ± 5.6% and 8.5 ± 5.8%, p = 0.0011).","[{'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Miyazaki', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka General Medical Center, 3-1-56, Bandaihigashi Sumiyoshi-ku, Osaka, 558-8558, Japan. ymiyazaki02@gh.opho.jp.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Omori', 'Affiliation': 'Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Kazumasa', 'Initials': 'K', 'LastName': 'Fujitani', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka General Medical Center, 3-1-56, Bandaihigashi Sumiyoshi-ku, Osaka, 558-8558, Japan.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Fujita', 'Affiliation': 'Sakai City Medical Center, Sakai, Japan.'}, {'ForeName': 'Ryohei', 'Initials': 'R', 'LastName': 'Kawabata', 'Affiliation': 'Osaka Rosai Hospital, Sakai, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Imamura', 'Affiliation': 'Toyonaka Municipal Hospital Osaka, Toyonaka, Japan.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Okada', 'Affiliation': 'Hyogo Prefectural Nishinomiya Hospital, Nishinomiya, Japan.'}, {'ForeName': 'Jeong-Ho', 'Initials': 'JH', 'LastName': 'Moon', 'Affiliation': 'NTT West Osaka Hospital, Osaka, Japan.'}, {'ForeName': 'Motohiro', 'Initials': 'M', 'LastName': 'Hirao', 'Affiliation': 'National Hospital Organization Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Matsuyama', 'Affiliation': 'Yao Municipal Hospital, Yao, Japan.'}, {'ForeName': 'Takuro', 'Initials': 'T', 'LastName': 'Saito', 'Affiliation': 'Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Yukinori', 'Initials': 'Y', 'LastName': 'Kurokawa', 'Affiliation': 'Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Yamasaki', 'Affiliation': 'Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Takiguchi', 'Affiliation': 'Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Mori', 'Affiliation': 'Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Doki', 'Affiliation': 'Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association,['10.1007/s10120-021-01188-3'] 3091,33835256,Prevention of non-cavitated lesions with fluoride and xylitol varnishes during orthodontic treatment: a randomized clinical trial.,"OBJECTIVE Fixed orthodontic appliances impair oral hygiene increasing the risk of non-cavitated lesions (NCLs) and tooth decay. The aim of this study was to compare the outcomes of fluoride and xylitol varnishes in preventing NCLs during comprehensive orthodontic treatment. MATERIALS AND METHODS The sample comprised 55 volunteers from 15 to 20 years of age under orthodontic treatment that were randomly divided into three groups: Fluoride Group (FG; n=17), Xylitol Group (XG; n=19), and Placebo Group (PG; n=19). The patients in each group received two applications of the following varnishes: Duraphat TM (5% NaF), 20% xylitol, and placebo (no F/Xylitol) in the three groups, respectively. The varnishes were applied in the first appointment (T0) and 3 months later (T1). Clinical examinations were carried out at T0 and 6 months after (T2) using the ICDAS index and the QLF system (fluorescence difference). The intergroup comparisons were performed by ANOVA/Tukey's or Kruskal-Wallis/Dunn's tests (P<0.05). RESULTS There was no significant intergroup difference regarding ICDAS index changes from T0 to T2. Fluoride varnish produced significantly greater increase in fluorescence of NCLs (mean change of -0.65 +0.78 and -0.56 +0.83, for maxilla and mandible, respectively) in comparison to the other groups. The majority of non-cavitated lesions improved in the fluoride and xylitol varnish groups. CONCLUSIONS Fluoride varnish produced significantly greater increase in enamel fluorescence compared to xylitol and placebo varnishes. In short term, both fluoride and xylitol varnishes produced remineralization of NCLs in orthodontic patients. CLINICAL RELEVANCE Non-cavitated lesions can be effectively controlled in high-risk orthodontic patients by means of fluoride varnishes. CLINICAL TRIAL REGISTRATION ReBEC Identifier: RBR-6mdxfq; Date of Register: March 19th, 2020. Retrospectively Registered.",2021,"CLINICAL RELEVANCE Non-cavitated lesions can be effectively controlled in high-risk orthodontic patients by means of fluoride varnishes. ","['55 volunteers from 15 to 20 years of age under orthodontic treatment', 'orthodontic patients']","['Fluoride varnish', 'fluoride and xylitol varnishes', 'Fluoride Group (FG; n=17), Xylitol Group (XG', 'varnishes: Duraphat TM (5% NaF), 20% xylitol, and placebo (no F/Xylitol', 'Placebo']","['remineralization of NCLs', 'enamel fluorescence', 'majority of non-cavitated lesions', 'ICDAS index changes', 'fluorescence of NCLs']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0043369', 'cui_str': 'Xylitol'}, {'cui': 'C0042359', 'cui_str': 'Varnish'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0058817', 'cui_str': 'Duraphat'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",55.0,0.118074,"CLINICAL RELEVANCE Non-cavitated lesions can be effectively controlled in high-risk orthodontic patients by means of fluoride varnishes. ","[{'ForeName': 'Vinicius Merino', 'Initials': 'VM', 'LastName': 'Silva', 'Affiliation': 'Bauru Dental School, Department of Orthodontics, University of São Paulo, Alameda Octávio Pinheiro Brisolla 9-75, Bauru, SP, 17012-901, Brazil. vinisilva@usp.br.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Massaro', 'Affiliation': 'Bauru Dental School, Department of Orthodontics, University of São Paulo, Alameda Octávio Pinheiro Brisolla 9-75, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Marilia Afonso Rabelo', 'Initials': 'MAR', 'LastName': 'Buzalaf', 'Affiliation': 'Bauru Dental School, Department of Biochemistry, University of São Paulo, Alameda Octávio Pinheiro Brisolla 9-75, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': 'Janson', 'Affiliation': 'Bauru Dental School, Department of Orthodontics, University of São Paulo, Alameda Octávio Pinheiro Brisolla 9-75, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Garib', 'Affiliation': 'Bauru Dental School and Hospital for Rehabilitation of Craniofacial Anomalies, University of São Paulo, Alameda Octávio Pinheiro Brisolla 9-75, Bauru, SP, 17012-901, Brazil.'}]",Clinical oral investigations,['10.1007/s00784-021-03930-8'] 3092,33835103,Do Relaxation Exercises Decrease Pain After Arthroscopic Rotator Cuff Repair? A Randomized Controlled Trial.,"BACKGROUND Pain after rotator cuff repair is commonly managed with opioid medications; however, these medications are associated with serious adverse effects. Relaxation exercises represent a potential nonpharmacologic method of pain management that can be easily implemented without substantial adverse effects; however, the effects of relaxation exercises have not been studied in a practical, reproducible protocol after arthroscopic rotator cuff repair. QUESTIONS/PURPOSES (1) Does performing relaxation exercises after arthroscopic rotator cuff repair (ARCR) decrease pain compared with standard pain management medication? (2) Does performing relaxation exercises after ARCR decrease opioid consumption? (3) What proportion of patients who used the relaxation techniques believed they decreased their pain level, and what proportion continued using these techniques at 2 weeks? (4) Does performing relaxation exercises after ARCR affect shoulder function? METHODS During the study period, 563 patients were eligible for inclusion; however, only 146 were enrolled, randomized, and postoperatively followed (relaxation group: 74, control group: 72); 68% (384 of 563) of patients were not contacted due to patient and research staff availability. Thirty-three patients were unenrolled preoperatively or immediately postoperatively due to change in operative procedure (such as, only debridement) or patient request; no postoperative data were collected from these patients. Follow-up proportions were similar between the relaxation and control groups (relaxation: 80%, control: 81%; p = 0.90). The relaxation group received and reviewed educational materials consisting of a 5-minute video and an educational pamphlet explaining relaxation breathing techniques, while the control group did not receive relaxation education materials. Patients recorded their pain levels and opioid consumption during the 5 days after ARCR. Patients also completed the American Shoulder and Elbow Surgeons shoulder score preoperatively and 2, 6, 13, 18, and 26 weeks postoperatively. Linear mixed models were created to analyze postoperative pain, opioid consumption measured in morphine milligram equivalents (MMEs), and shoulder function outcomes. A per-protocol approach was used to correct for patients who were enrolled but subsequently underwent other procedures. RESULTS There was no difference in pain scores between the relaxation and control groups during the first 5 days postoperatively. There was no difference in pain scores at 2 weeks postoperatively between the relaxation and control groups (3.3 ± 3 versus 3.5 ± 2, mean difference -0.22 [95% CI -1.06 to 0.62]; p = 0.60). There was no difference in opioid consumption during the first 5 days postoperatively between the relaxation and control groups. The use of relaxation exercises resulted in lower 2-week narcotics consumption in the relaxation group than in the control group (309 ± 241 MMEs versus 442 ± 307 MMEs, mean difference -133 [95% CI -225 to -42]; p < 0.01). Sixty-two percent (41 of 66) of patients in the relaxation group believed the relaxation exercises decreased their pain levels. Fifty-two percent (34 of 66) were still performing the exercises at 2 weeks postoperatively. During the 6-month follow-up period, there was no difference in shoulder function between the relaxation and control groups. CONCLUSION The preoperative administration of quick, basic relaxation exercises allowed patients to use appreciably lower opioid analgesic doses over the first 2 weeks after ARCR, without any worsening of pain scores. We consider this result promising but preliminary; it is possible that a more intense mindfulness intervention-the one we studied here was disseminated using only a 5-minute video-would deliver reductions in pain and further reductions in opioid usage. LEVEL OF EVIDENCE Level II, therapeutic study.",2021,"The use of relaxation exercises resulted in lower 2-week narcotics consumption in the relaxation group than in the control group (309 ± 241 MMEs versus 442 ± 307 MMEs, mean difference -133","['563 patients were eligible for inclusion; however, only 146 were enrolled, randomized, and postoperatively followed (relaxation group: 74, control group: 72); 68% (384 of 563) of patients were not contacted due to patient and research staff availability', 'patients who were enrolled but subsequently underwent other procedures']","['Relaxation exercises', 'educational materials consisting of a 5-minute video and an educational pamphlet explaining relaxation breathing techniques, while the control group did not receive relaxation education materials', 'relaxation exercises after arthroscopic rotator cuff repair (ARCR', 'Relaxation Exercises', 'quick, basic relaxation exercises', 'relaxation exercises']","['opioid analgesic doses', 'postoperative pain, opioid consumption measured in morphine milligram equivalents (MMEs), and shoulder function outcomes', 'shoulder function', 'Pain', 'pain scores', 'opioid consumption', 'pain level', 'pain levels', 'pain levels and opioid consumption', 'lower 2-week narcotics consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0203993', 'cui_str': 'Relaxation exercise'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}]",563.0,0.0237757,"The use of relaxation exercises resulted in lower 2-week narcotics consumption in the relaxation group than in the control group (309 ± 241 MMEs versus 442 ± 307 MMEs, mean difference -133","[{'ForeName': 'Danielle G', 'Initials': 'DG', 'LastName': 'Weekes', 'Affiliation': 'D. G. Weekes, R. E. Campbell, E. D. Wicks, C. J. Hadley, Z. S. Chaudhry, A. H. Carter, M. D. Pepe, B. S. Tucker, K. B. Freedman, F. P. Tjoumakaris, The Rothman Orthopaedic Institute, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Campbell', 'Affiliation': 'D. G. Weekes, R. E. Campbell, E. D. Wicks, C. J. Hadley, Z. S. Chaudhry, A. H. Carter, M. D. Pepe, B. S. Tucker, K. B. Freedman, F. P. Tjoumakaris, The Rothman Orthopaedic Institute, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Wicks', 'Affiliation': 'D. G. Weekes, R. E. Campbell, E. D. Wicks, C. J. Hadley, Z. S. Chaudhry, A. H. Carter, M. D. Pepe, B. S. Tucker, K. B. Freedman, F. P. Tjoumakaris, The Rothman Orthopaedic Institute, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Hadley', 'Affiliation': 'D. G. Weekes, R. E. Campbell, E. D. Wicks, C. J. Hadley, Z. S. Chaudhry, A. H. Carter, M. D. Pepe, B. S. Tucker, K. B. Freedman, F. P. Tjoumakaris, The Rothman Orthopaedic Institute, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Zaira S', 'Initials': 'ZS', 'LastName': 'Chaudhry', 'Affiliation': 'D. G. Weekes, R. E. Campbell, E. D. Wicks, C. J. Hadley, Z. S. Chaudhry, A. H. Carter, M. D. Pepe, B. S. Tucker, K. B. Freedman, F. P. Tjoumakaris, The Rothman Orthopaedic Institute, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Aaron H', 'Initials': 'AH', 'LastName': 'Carter', 'Affiliation': 'D. G. Weekes, R. E. Campbell, E. D. Wicks, C. J. Hadley, Z. S. Chaudhry, A. H. Carter, M. D. Pepe, B. S. Tucker, K. B. Freedman, F. P. Tjoumakaris, The Rothman Orthopaedic Institute, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Pepe', 'Affiliation': 'D. G. Weekes, R. E. Campbell, E. D. Wicks, C. J. Hadley, Z. S. Chaudhry, A. H. Carter, M. D. Pepe, B. S. Tucker, K. B. Freedman, F. P. Tjoumakaris, The Rothman Orthopaedic Institute, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Bradford S', 'Initials': 'BS', 'LastName': 'Tucker', 'Affiliation': 'D. G. Weekes, R. E. Campbell, E. D. Wicks, C. J. Hadley, Z. S. Chaudhry, A. H. Carter, M. D. Pepe, B. S. Tucker, K. B. Freedman, F. P. Tjoumakaris, The Rothman Orthopaedic Institute, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Kevin B', 'Initials': 'KB', 'LastName': 'Freedman', 'Affiliation': 'D. G. Weekes, R. E. Campbell, E. D. Wicks, C. J. Hadley, Z. S. Chaudhry, A. H. Carter, M. D. Pepe, B. S. Tucker, K. B. Freedman, F. P. Tjoumakaris, The Rothman Orthopaedic Institute, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Fotios P', 'Initials': 'FP', 'LastName': 'Tjoumakaris', 'Affiliation': 'D. G. Weekes, R. E. Campbell, E. D. Wicks, C. J. Hadley, Z. S. Chaudhry, A. H. Carter, M. D. Pepe, B. S. Tucker, K. B. Freedman, F. P. Tjoumakaris, The Rothman Orthopaedic Institute, Thomas Jefferson University, Philadelphia, PA, USA.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001723'] 3093,33835071,A randomized clinical study to compare implant stability and bone loss using early loading protocol in two implant systems with different design.,"Aims The study compared changes in implant stability and bone loss of implants with different designs using early loading at 6 weeks. Setting and Design In vivo-comparative study. Materials and Methods Forty subjects were selected and divided randomly by sealed envelope method in Group X and Group A for early loading for missing single posterior tooth in mandible. Implants in Group X had flared crest module and buttress thread design, whereas implants in Group A had parallel crest module and V-shaped thread design. All subjects were evaluated by Ostell for implant stability at the interval of baseline, 6 weeks, 3 months, and 6 months. ImageJ software was used for measurement of crestal bone loss in intraoral periapical radiographs at the interval of 6 weeks, 3 months, and 6 months. Statistical Analysis Used Unpaired t test, repeated ANOVA, Tukey post hoc test. Results The mean bone loss values of Group X at predetermined interval were 1.51 ± 0.20 mm, 2.11 ± 0.21 mm and 2.13 ± 0.21 mm. The mean bone loss values of Group A were 1.79 ± 0.16 mm, 2.92 ± 0.23 mm and 2.95 ± 0.23 mm. The mean bone loss was statistical significant (P < 0.05) at 6 weeks, 3 months and 6 months. It was highly significant in Group A at 6 months (P < 0.001). Conclusions It was concluded that Group X implants design showed better implant stability and less bone loss when compared to Group A implants design.",2021,"The mean bone loss was statistical significant (P < 0.05) at 6 weeks, 3 months and 6 months.",['Materials and Methods\n\n\nForty subjects'],[],"['mean bone loss', 'mean bone loss values', 'crestal bone loss', 'implant stability', 'bone loss', 'implant stability and bone loss']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",40.0,0.031461,"The mean bone loss was statistical significant (P < 0.05) at 6 weeks, 3 months and 6 months.","[{'ForeName': 'Rani', 'Initials': 'R', 'LastName': 'Ranabhatt', 'Affiliation': ""Department of Prosthodontics, Faculty of Dental Sciences, King George's Medical University, Lucknow, Uttar Pradesh, India.""}, {'ForeName': 'Kamleshwar', 'Initials': 'K', 'LastName': 'Singh', 'Affiliation': ""Department of Prosthodontics, Faculty of Dental Sciences, King George's Medical University, Lucknow, Uttar Pradesh, India.""}, {'ForeName': 'Ramashanker', 'Initials': 'R', 'LastName': 'Siddharth', 'Affiliation': ""Department of Prosthodontics, Faculty of Dental Sciences, King George's Medical University, Lucknow, Uttar Pradesh, India.""}, {'ForeName': 'Shuchi', 'Initials': 'S', 'LastName': 'Tripathi', 'Affiliation': ""Department of Prosthodontics, Faculty of Dental Sciences, King George's Medical University, Lucknow, Uttar Pradesh, India.""}, {'ForeName': 'Deeksha', 'Initials': 'D', 'LastName': 'Arya', 'Affiliation': ""Department of Prosthodontics, Faculty of Dental Sciences, King George's Medical University, Lucknow, Uttar Pradesh, India.""}]",Journal of Indian Prosthodontic Society,['10.4103/jips.jips_297_20'] 3094,33835089,Impacts of Rehabilitation Gait Training on Functional Outcomes after Tibial Nerve Transfer for Patients with Peroneal Nerve Injury: A Nonrandomized Controlled Trial.,"BACKGROUND Although there was initial success using tibial nerve transfer to restore ankle dorsiflexion following peroneal nerve injury, results from later series were less promising. A potential reason is coactivation of the much stronger antagonistic muscles during gait. The purpose of this study was to test the hypothesis that gait training would improve functional performance following tibial nerve transfer. METHODS Using a prospective, nonrandomized, controlled study design, patients were divided into two groups: surgery only or surgery plus gait training. Of the 20 patients who showed reinnervation in the tibialis anterior muscle, 10 were assigned to the gait training group, and an equal number were in the control group. Those in the treatment group began training once reinnervation in the tibialis anterior muscle was detected, whereas those in the control group continued to use their ankle-foot orthosis full time. Differences in ankle dorsiflexion was measured using the Medical Research Council scale, and quantitative force measurement and functional disability was measured using the Stanmore Scale. RESULTS Patients in the gait training group attained significantly better functional recovery as measured by the Stanmore Scale (79.5 ± 14.3) (mean ± SD) versus (37.2 ± 3.5) in the control group (p = 0.02). Medical Research Council grades were 3.8 ± 0.6 in the training group versus 2.5 ± 1.2 in the surgery only group (p < 0.05). Average dorsiflexion force from patients with above antigravity strength (all from the training group) was 31 percent of the contralateral side. CONCLUSION In patients with successful reinnervation following tibial nerve transfers, rehabilitation training significantly improved dorsiflexion strength and function. CLINICAL QUESTION/LEVEL OF EVIDENCE Therapeutic, II.",2021,"In patients with successful reinnervation following tibial nerve transfers, rehabilitation training significantly improved dorsiflexion strength and function. ","['20 patients who showed reinnervation in the tibialis anterior muscle', 'Patients with Peroneal Nerve Injury']","['Rehabilitation Gait Training', 'tibial nerve transfer', 'tibial nerve transfers, rehabilitation training', 'gait training', 'surgery only or surgery plus gait training']","['Functional Outcomes', 'ankle dorsiflexion', 'Medical Research Council scale, and quantitative force measurement and functional disability', 'dorsiflexion strength and function', 'Average dorsiflexion force', 'functional performance', 'functional recovery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231508', 'cui_str': 'Reinnervation'}, {'cui': 'C0242690', 'cui_str': 'Tibialis anterior muscle structure'}, {'cui': 'C0161470', 'cui_str': 'Traumatic injury of common peroneal nerve'}]","[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}]",,0.0119496,"In patients with successful reinnervation following tibial nerve transfers, rehabilitation training significantly improved dorsiflexion strength and function. ","[{'ForeName': 'Matthew W T', 'Initials': 'MWT', 'LastName': 'Curran', 'Affiliation': 'From the Department of Surgery, Division of Plastic Surgery, and the Department of Medicine, Division of Physical Medicine and Rehabilitation, University of Alberta.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morhart', 'Affiliation': 'From the Department of Surgery, Division of Plastic Surgery, and the Department of Medicine, Division of Physical Medicine and Rehabilitation, University of Alberta.'}, {'ForeName': 'Jaret L', 'Initials': 'JL', 'LastName': 'Olson', 'Affiliation': 'From the Department of Surgery, Division of Plastic Surgery, and the Department of Medicine, Division of Physical Medicine and Rehabilitation, University of Alberta.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'DeSerres', 'Affiliation': 'From the Department of Surgery, Division of Plastic Surgery, and the Department of Medicine, Division of Physical Medicine and Rehabilitation, University of Alberta.'}, {'ForeName': 'K Ming', 'Initials': 'KM', 'LastName': 'Chan', 'Affiliation': 'From the Department of Surgery, Division of Plastic Surgery, and the Department of Medicine, Division of Physical Medicine and Rehabilitation, University of Alberta.'}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000007896'] 3095,33835084,Goal-directed Fluid Therapy Versus Conventional Fluid Therapy During Craniotomy and Clipping of Cerebral Aneurysm: A Prospective Randomized Controlled Trial.,"BACKGROUND Fluid imbalance is common after aneurysmal subarachnoid hemorrhage and negatively impacts clinical outcomes. We compared intraoperative goal-directed fluid therapy (GDFT) using left ventricular outflow tract velocity time integral (LVOT-VTI) measured by transesophageal echocardiography with central venous pressure (CVP)-guided fluid therapy during aneurysm clipping in aneurysmal subarachnoid hemorrhage patients. METHODS Fifty adults scheduled for urgent craniotomy for aneurysm clipping were randomly allocated to 2 groups: group G (n=25) received GDFT guided by LVOT-VTI and group C (n=25) received CVP-guided fluid management. The primary outcome was intraoperative mean arterial pressure (MAP). Secondary outcomes included volume of fluid administered and several other intraoperative and postoperative variables, including neurological outcome at hospital discharge and at 30 and 90 days. RESULTS There was no difference in MAP between the 2 groups despite patients in group G receiving lower volumes of fluid compared with patients in group C (2503.6±534.3 vs. 3732.8±676.5 mL, respectively; P<0.0001). Heart rate and diastolic blood pressure were also comparable between groups, whereas systolic blood pressure was higher in group G than in group C at several intraoperative time points. Other intraoperative variables, including blood loss, urine output, and lactate levels were not different between the 2 groups. Postoperative variables, including creatinine, duration of postoperative mechanical ventilation, length of intensive care unit and hospital stay, and incidence of acute kidney injury, pneumonitis, and vasospasm were also comparable between groups. There was no difference in neurological outcome at hospital discharge (modified Rankin scale) and at 30 and 90 days (Extended Glasgow Outcome Scale) between the 2 groups. CONCLUSION Compared with CVP-guided fluid therapy, transesophageal echocardiography-guided GDFT maintains MAP with lower volumes of intravenous fluid in patients undergoing clipping of intracranial aneurysms with no adverse impact on postoperative complications.",2021,"There was no difference in neurological outcome at hospital discharge (modified Rankin scale) and at 30 and 90 days (Extended Glasgow Outcome Scale) between the 2 groups. ","['aneurysmal subarachnoid hemorrhage patients', 'Fifty adults scheduled for urgent craniotomy for aneurysm clipping', 'Cerebral Aneurysm']","['CVP-guided fluid management', 'GDFT guided by LVOT-VTI and group C', 'Fluid Therapy Versus Conventional Fluid Therapy', 'intraoperative goal-directed fluid therapy (GDFT) using left ventricular outflow tract velocity time integral (LVOT-VTI) measured by transesophageal echocardiography with central venous pressure (CVP)-guided fluid therapy', 'CVP-guided fluid therapy, transesophageal echocardiography-guided GDFT maintains MAP']","['MAP', 'Heart rate and diastolic blood pressure', 'neurological outcome at hospital discharge (modified Rankin scale', 'systolic blood pressure', 'intraoperative mean arterial pressure (MAP', 'blood loss, urine output, and lactate levels', 'Postoperative variables, including creatinine, duration of postoperative mechanical ventilation, length of intensive care unit and hospital stay, and incidence of acute kidney injury, pneumonitis, and vasospasm', 'postoperative complications', 'volume of fluid administered and several other intraoperative and postoperative variables, including neurological outcome at hospital discharge and at 30 and 90 days']","[{'cui': 'C0751530', 'cui_str': 'Subarachnoid Hemorrhage, Aneurysmal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0155730', 'cui_str': 'Cerebral aneurysm, nonruptured'}]","[{'cui': 'C0199666', 'cui_str': 'Measurement of central venous pressure'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0553741', 'cui_str': 'Fluid balance regulation'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443238', 'cui_str': 'Integral'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0225912', 'cui_str': 'Structure of outflow tract of left ventricle'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0206054', 'cui_str': 'Transesophageal echocardiography'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]","[{'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C3714636', 'cui_str': 'Pneumonitis'}, {'cui': 'C0042396', 'cui_str': 'Vascular constriction'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",50.0,0.553925,"There was no difference in neurological outcome at hospital discharge (modified Rankin scale) and at 30 and 90 days (Extended Glasgow Outcome Scale) between the 2 groups. ","[{'ForeName': 'Summit D', 'Initials': 'SD', 'LastName': 'Bloria', 'Affiliation': 'Departments of Anaesthesia and Intensive Care Neurosurgery, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Nidhi B', 'Initials': 'NB', 'LastName': 'Panda', 'Affiliation': ''}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Jangra', 'Affiliation': ''}, {'ForeName': 'Hemant', 'Initials': 'H', 'LastName': 'Bhagat', 'Affiliation': ''}, {'ForeName': 'Banashree', 'Initials': 'B', 'LastName': 'Mandal', 'Affiliation': ''}, {'ForeName': 'Ketan', 'Initials': 'K', 'LastName': 'Kataria', 'Affiliation': ''}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Chauhan', 'Affiliation': ''}, {'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Luthra', 'Affiliation': ''}, {'ForeName': 'Shiv Lal', 'Initials': 'SL', 'LastName': 'Soni', 'Affiliation': ''}, {'ForeName': 'Narender', 'Initials': 'N', 'LastName': 'Kaloria', 'Affiliation': ''}, {'ForeName': 'Shalvi', 'Initials': 'S', 'LastName': 'Mahajan', 'Affiliation': ''}, {'ForeName': 'Shamik Kr', 'Initials': 'SK', 'LastName': 'Paul', 'Affiliation': ''}, {'ForeName': 'Shailesh', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': ''}, {'ForeName': 'Sanket', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': ''}, {'ForeName': 'Navneet', 'Initials': 'N', 'LastName': 'Singla', 'Affiliation': ''}]",Journal of neurosurgical anesthesiology,['10.1097/ANA.0000000000000769'] 3096,33835077,Difficulty in Advancing Flexible Epidural Catheters When Establishing Labor Analgesia: An Observational Open-Label Randomized Trial.,"BACKGROUND While flexible epidural catheters reduce the risk of paresthesia and intravascular cannulation, they may be more challenging to advance beyond the tip of a Tuohy needle. This may increase placement time, number of attempts, and possibly complications when establishing labor analgesia. This study investigated the ability to advance flexible epidural catheters through different epidural needles from 2 commonly used, commercially available, epidural kits. METHODS We hypothesized that the multiorifice wire-reinforced polyamide nylon blend epidural catheters will have a higher rate of successful first attempt insertion than the single-end hole wire-reinforced polyurethane catheters for the establishment of labor analgesia. The primary outcome was a difference in proportions of failure to advance the epidural catheter between the 2 epidural kits and was tested by a χ2 test. Two-hundred forty epidural kits were collected (n = 120/group) for 240 laboring patients requesting epidural analgesia in this open-label clinical trial from November 2018 to September 2019. Two-week time intervals were randomized for the exclusive use of 1 of the 2 kits in this study, where all patients received labor analgesia through either the flexible epidural catheter ""A"" or the flexible epidural catheter ""B."" Engineering properties of the equipment used were then determined. RESULTS Flexible epidural catheter ""A,"" the single-end hole wire-reinforced polyurethane catheter, did not advance at the first attempt in 15% (n = 18 of 120) of the parturients compared to 0.8% (n = 1 of 120) of the catheter ""B,"" the multiorifice wire-reinforced polyamide nylon blend epidural catheter (P < .0001). Twenty-five additional epidural needle manipulations were recorded in the laboring patients who received catheter ""A,"" while 1 epidural needle manipulation was recorded in the parturients who received catheter ""B"" (P < .0001). Bending stiffness of the epidural catheters used from kit ""B"" was twice the bending stiffness of the catheters used from kit ""A"" (bending stiffness catheters ""A"" 0.64 ± 0.04 N·mm2 versus bending stiffness catheters ""B"" 1.28 ± 0.20 N·mm2, P = .0038), and the angle formed by the needle and the epidural catheter from kit ""A"" was less acute than the angle formed from kit ""B"" (kit ""A"" 14.17 ± 1.72° versus kit ""B"" 21.83 ± 1.33°, P = .0036), with a mean difference of 7.66° between the 2 kits' angles. CONCLUSIONS The incidence of an inability to advance single-end hole wire-reinforced polyurethane catheter was higher compared to the use of multiorifice wire-reinforced polyamide nylon blend epidural catheter. Variation of morphological features of epidural needles and catheters may play a critical role in determining the successful establishment of labor epidural analgesia.",2021,The incidence of an inability to advance single-end hole wire-reinforced polyurethane catheter was higher compared to the use of multiorifice wire-reinforced polyamide nylon blend epidural catheter.,['Two-hundred forty epidural kits were collected (n = 120/group) for 240 laboring patients requesting epidural analgesia in this open-label clinical trial from November 2018 to September 2019'],"['labor analgesia through either the flexible epidural catheter ""A', 'multiorifice wire-reinforced polyamide nylon blend epidural catheter']",['proportions of failure to advance the epidural catheter'],"[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0581040', 'cui_str': 'Patient requested epidural'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1301740', 'cui_str': 'Analgesia in labor'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0179751', 'cui_str': 'Epidural catheter'}, {'cui': 'C0005978', 'cui_str': 'Bone wire'}, {'cui': 'C0028736', 'cui_str': 'Nylon'}]","[{'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0179751', 'cui_str': 'Epidural catheter'}]",,0.0795701,The incidence of an inability to advance single-end hole wire-reinforced polyurethane catheter was higher compared to the use of multiorifice wire-reinforced polyamide nylon blend epidural catheter.,"[{'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Pancaro', 'Affiliation': 'From the Department of Anesthesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Purtell', 'Affiliation': 'From the Department of Anesthesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'LaBuda', 'Affiliation': 'From the Department of Anesthesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Saager', 'Affiliation': 'Department of Anesthesiology, University Medical Center, Göttingen, Germany.'}, {'ForeName': 'Thomas T', 'Initials': 'TT', 'LastName': 'Klumpner', 'Affiliation': 'From the Department of Anesthesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Timur', 'Initials': 'T', 'LastName': 'Dubovoy', 'Affiliation': 'From the Department of Anesthesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Baskar', 'Initials': 'B', 'LastName': 'Rajala', 'Affiliation': 'From the Department of Anesthesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Shubhangi', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'From the Department of Anesthesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Cassidy', 'Affiliation': 'From the Department of Anesthesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Christie', 'Initials': 'C', 'LastName': 'Vahabzadeh', 'Affiliation': 'Department of Anesthesiology, Beaumont, Royal Oak, Michigan.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Maxwell', 'Affiliation': 'From the Department of Anesthesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Virgil', 'Initials': 'V', 'LastName': 'Manica', 'Affiliation': 'Department of Anesthesiology, Tufts University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Eckmann', 'Affiliation': 'Department of Anesthesiology and Center for Medical and Engineering Innovation, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Mhyre', 'Affiliation': 'Department of Anesthesiology, University of Arkansas for Medical Sciences, Little Rock, Arkansas.'}, {'ForeName': 'Milo C', 'Initials': 'MC', 'LastName': 'Engoren', 'Affiliation': 'From the Department of Anesthesiology, University of Michigan, Ann Arbor, Michigan.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005526'] 3097,33834718,[The results of a study on the safety of the dietary supplement neurouridine in patients with nonspecific low back pain (MULTINEURO-2)].,"OBJECTIVE To assess the efficacy and safety of high (300 mg) doses of the biologically active additive neurouridin (Unifarm) as part of complex therapy of patients with nonspecific low-back pain. MATERIAL AND METHODS Fifty patients (30 in the main group and 20 patients in the control group) were studied using a visual analogue scale (VAS), data from a general clinical analysis of blood and urine, a wide range of biochemical parameters, including liver function tests, glucose levels, creatinine, electrolyte levels. RESULTS AND CONCLUSION The positive effect of treatment with neurouridin on the dynamics of changes in pain according to the VAS was noted, a dose-dependent effect was revealed: patients at higher doses (300 mg of uridine monophosphate) showed a more significant regression of pain symptoms compared to standard doses. During the study, there were no serious adverse events allergic reactions. No clinically significant deviations of laboratory parameters were recorded.",2021,"The positive effect of treatment with neurouridin on the dynamics of changes in pain according to the VAS was noted, a dose-dependent effect was revealed: patients at higher doses (300 mg of uridine monophosphate) showed a more significant regression of pain symptoms compared to standard doses.","['Fifty patients (30 in the main group and 20 patients in the control group', 'patients with nonspecific low back pain (MULTINEURO-2', 'patients with nonspecific low-back pain']","['neurouridin', 'biologically active additive neurouridin (Unifarm', 'dietary supplement neurouridine']","['serious adverse events allergic reactions', 'liver function tests, glucose levels, creatinine, electrolyte levels', 'efficacy and safety', 'pain symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0205460', 'cui_str': 'Biologic'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0442796', 'cui_str': 'Additive'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0023901', 'cui_str': 'Hepatic function panel'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0428284', 'cui_str': 'Electrolyte levels - finding'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0364008,"The positive effect of treatment with neurouridin on the dynamics of changes in pain according to the VAS was noted, a dose-dependent effect was revealed: patients at higher doses (300 mg of uridine monophosphate) showed a more significant regression of pain symptoms compared to standard doses.","[{'ForeName': 'E Z', 'Initials': 'EZ', 'LastName': 'Yakupov', 'Affiliation': 'Scientific Research Medical Complex «Your Health», Kazan, Russia.'}, {'ForeName': 'J V', 'Initials': 'JV', 'LastName': 'Troshina', 'Affiliation': 'Scientific Research Medical Complex «Your Health», Kazan, Russia.'}, {'ForeName': 'R R', 'Initials': 'RR', 'LastName': 'Gainutdinova', 'Affiliation': 'Scientific Research Medical Complex «Your Health», Kazan, Russia.'}, {'ForeName': 'A O', 'Initials': 'AO', 'LastName': 'Kashapova', 'Affiliation': 'Scientific Research Medical Complex «Your Health», Kazan, Russia.'}]",Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova,['10.17116/jnevro202112103152'] 3098,33834671,[Clinical study of age-related sensory innervation of the anterior hard palate].,"OBJECTIVES The present study aimed to explore the innervation of the anterior hard palatine and its relationship with individual development stage. Specifically, the effects of anesthesia on patients of different ages were observed, and neurodevelopment in the maxillofacial region was invesitgated. References that are helpful in selecting local anesthesia were provided. METHODS A total of 182 patients with mixed dentition were randomly divided into the nasopalatine nerve block and greater palatine nerve block groups. Then, 219 patients with permanent dentition were divided into an adolescent group (13-18 years old) and adult group (over 19 years old), all of whom underwent bilateral greater palatine nerve block. Palatal mucosal pain sensation was tested pre- and post-anesthesia with Von Frey hairs. RESULTS Among the children with mixed dentition, bilateral greater palatine nerve block tended to result in better anesthetic effects than nasopalatine nerve block ( P <0.05), except in the incisive papilla. No difference in anesthetic effect was observed between adolescents and adults ( P >0.05). The bilateral greater palatine nerve block was more effective in inducing an anesthestic effect in the anterior hard palatine in mixed dentition than in permanent dentition (over 13 years old; P <0.05). CONCLUSIONS The sensation of the anterior hard palatine seems mainly dominated by the greater palatine nerve until mixed dentition and gradually shifted to the nasopalatine nerve in conjunction with maxillary development and tooth replacement. Hence, the innervation of the anterior hard palatine induce a secondary development during the development of the maxilla.",2021,"The bilateral greater palatine nerve block was more effective in inducing an anesthestic effect in the anterior hard palatine in mixed dentition than in permanent dentition (over 13 years old; P <0.05). ","['219 patients with permanent dentition', '182 patients with mixed dentition']","['nasopalatine nerve block and greater palatine nerve block groups', 'bilateral greater palatine nerve block']","['Palatal mucosal pain sensation', 'anesthetic effect']","[{'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0348070', 'cui_str': 'Structure of permanent tooth'}, {'cui': 'C0011444', 'cui_str': 'Mixed dentition'}]","[{'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0858804', 'cui_str': 'Mucosal pain'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C3179301', 'cui_str': 'Anesthetic Effects'}]",219.0,0.0557866,"The bilateral greater palatine nerve block was more effective in inducing an anesthestic effect in the anterior hard palatine in mixed dentition than in permanent dentition (over 13 years old; P <0.05). ","[{'ForeName': 'Xiu-Fen', 'Initials': 'XF', 'LastName': 'Li', 'Affiliation': 'Dept. of Stomatology, Tongde Hospital of Zhejiang Province, Hangzhou 310012, China.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Oral Diseases & National Clinical Research Center for Oral Diseases & Dept. of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Ji-Yuan', 'Initials': 'JY', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Oral Diseases & National Clinical Research Center for Oral Diseases & Dept. of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Qu', 'Affiliation': 'State Key Laboratory of Oral Diseases & National Clinical Research Center for Oral Diseases & Dept. of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Wei-Lin', 'Initials': 'WL', 'LastName': 'Pan', 'Affiliation': 'State Key Laboratory of Oral Diseases & National Clinical Research Center for Oral Diseases & Dept. of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': 'State Key Laboratory of Oral Diseases & National Clinical Research Center for Oral Diseases & Dept. of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Cheng-Ge', 'Initials': 'CG', 'LastName': 'Hua', 'Affiliation': 'State Key Laboratory of Oral Diseases & National Clinical Research Center for Oral Diseases & Dept. of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China.'}]",Hua xi kou qiang yi xue za zhi = Huaxi kouqiang yixue zazhi = West China journal of stomatology,['10.7518/hxkq.2021.02.007'] 3099,33834643,Effect of desmopressin lyophilisate (MELT) plus anticholinergics combination on functional bladder capacity and therapeutic outcome as the first-line treatment for primary monosymptomatic nocturnal enuresis: A randomized clinical trial.,"PURPOSE To assess the efficacy of desmopressin plus anticholinergic combination therapy as first-line treatment for children with primary monosymptomatic nocturnal enuresis (PMNE) and to analyze this combination's effect on functional bladder capacity (FBC). MATERIALS AND METHODS A total of 99 children with PMNE were prospectively enrolled from 2015 to 2019 and randomly allocated to a monotherapy group (n=49), with oral desmopressin lyophilisate (MELT) only; and a combination group (n=50), with desmopressin plus an anticholinergic (propiverine 5 mg). Efficacy and FBC were evaluated at 1 and 3 months after treatment initiation; the relapse rate was assessed at 6 months after treatment cessation. RESULTS The combination therapy group showed a higher rate of complete response than the monotherapy group after 3 months of treatment (44.0% vs. 22.4%, p=0.002). A significant increase in mean FBC was observed only in the combination group, from 88.72±26.34 mL at baseline to 115.52±42.23 mL at 3 months of treatment (p=0.024). Combination therapy was significantly associated with treatment success at 3 months after treatment initiation (odds ratio [OR], 3.527; 95% confidence interval [CI], 1.203-6.983; p=0.011) and decreased risk of relapse at 6 months after treatment cessation (OR, 0.306; 95% CI, 0.213-0.894; p=0.021), by multivariable analysis. CONCLUSIONS This study represents the first prospective, randomized controlled trial showing higher response rates and lower relapse rates with desmopressin plus anticholinergic combination therapy compared with desmopressin monotherapy as first-line treatment for children with PMNE.",2021,"A significant increase in mean FBC was observed only in the combination group, from 88.72±26.34 mL at baseline to 115.52±42.23 mL at 3 months of treatment (p=0.024).","['primary monosymptomatic nocturnal enuresis', 'children with primary monosymptomatic nocturnal enuresis (PMNE', '99 children with PMNE', 'children with PMNE']","['desmopressin monotherapy', 'desmopressin plus anticholinergic combination therapy', 'desmopressin plus an anticholinergic (propiverine 5 mg', 'oral desmopressin lyophilisate (MELT', 'desmopressin lyophilisate (MELT) plus anticholinergics combination', 'monotherapy']","['relapse rate', 'risk of relapse', 'functional bladder capacity and therapeutic outcome', 'mean FBC', 'Efficacy and FBC', 'functional bladder capacity (FBC', 'rate of complete response']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0270327', 'cui_str': 'Nocturnal enuresis'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0011701', 'cui_str': 'desmopressin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0242896', 'cui_str': 'Acetylcholine receptor antagonist'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0138666', 'cui_str': 'propiverine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4518549', 'cui_str': 'Lyophilisate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0429808', 'cui_str': 'Functional bladder capacity'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",99.0,0.0410562,"A significant increase in mean FBC was observed only in the combination group, from 88.72±26.34 mL at baseline to 115.52±42.23 mL at 3 months of treatment (p=0.024).","[{'ForeName': 'Myungsun', 'Initials': 'M', 'LastName': 'Shim', 'Affiliation': 'Department of Urology, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Korea.'}, {'ForeName': 'Woo Jin', 'Initials': 'WJ', 'LastName': 'Bang', 'Affiliation': 'Department of Urology, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Korea.'}, {'ForeName': 'Cheol Young', 'Initials': 'CY', 'LastName': 'Oh', 'Affiliation': 'Department of Urology, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Korea. cyoh570@gmail.com.'}, {'ForeName': 'Min Jae', 'Initials': 'MJ', 'LastName': 'Kang', 'Affiliation': 'Department of Pediatrics, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Korea.'}, {'ForeName': 'Jin Seon', 'Initials': 'JS', 'LastName': 'Cho', 'Affiliation': 'Department of Urology, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Korea.'}]",Investigative and clinical urology,['10.4111/icu.20200303'] 3100,33834628,Remibrutinib (LOU064): A selective potent oral BTK inhibitor with promising clinical safety and pharmacodynamics in a randomized phase I trial.,"Safe and effective new oral therapies for autoimmune, allergic, and inflammatory conditions remain a significant therapeutic need. Here, we investigate the human pharmacokinetics, pharmacodynamics (PDs), and safety of the selective, covalent Bruton's tyrosine kinase (BTK) inhibitor, remibrutinib. Study objectives were explored in randomized single and multiple ascending dose (SAD and MAD, respectively) cohorts with daily doses up to 600 mg, and a crossover food effect (FE) cohort, in adult healthy subjects without (SAD [n =80]/FE [n =12]) or with asymptomatic atopic diathesis (MAD [n =64]). A single oral dose of remibrutinib (0.5-600 mg) was rapidly absorbed (time to maximum concentration = 0.5 h-1.25 h) with an apparent blood clearance of 280-560 L/h and apparent volume of distribution of 400-15,000 L. With multiple doses (q.d. and b.i.d.), no pronounced accumulation of remibrutinib was detected (mean residence time was <3 h). Food intake showed no clinically relevant effect on remibrutinib exposure suggesting no need for dose adaptation. With remibrutinib doses greater than or equal to 30 mg, blood BTK occupancy was greater than 95% for at least 24 h (SAD). With MAD, remibrutinib reached near complete blood BTK occupancy at day 12 predose with greater than or equal to 10 mg q.d. Near complete basophil or skin prick test (SPT) inhibition at day 12 predose was achieved at greater than or equal to 50 mg q.d. for CD63 and at greater than or equal to 100 mg q.d. for SPT. Remibrutinib was well-tolerated at all doses without any dose-limiting toxicity. Remibrutinib showed encouraging blood and skin PDs with a favorable safety profile, supporting further development for diseases driven by mast cells, basophils, and B-cells, such as chronic spontaneous urticaria, allergic asthma, or Sjögren's syndrome.",2021,Near complete basophil or skin prick test (SPT) inhibition at day 12 predose was achieved at greater than or equal to 50 mg q.d.,['adult healthy subjects without (SAD [n\xa0=80]/FE [n\xa0=12]) or with asymptomatic atopic diathesis (MAD [n\xa0=64'],['Remibrutinib (LOU064'],"[""human pharmacokinetics, pharmacodynamics (PDs), and safety of the selective, covalent Bruton's tyrosine kinase (BTK) inhibitor"", 'blood BTK occupancy', 'With MAD, remibrutinib reached near complete blood BTK occupancy', 'basophil or skin prick test (SPT) inhibition']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0392707', 'cui_str': 'Atopy'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}]",[],"[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0218158', 'cui_str': ""Bruton's Tyrosine Kinase""}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0004827', 'cui_str': 'Basophils'}, {'cui': 'C0430561', 'cui_str': 'Prick test'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",,0.0374505,Near complete basophil or skin prick test (SPT) inhibition at day 12 predose was achieved at greater than or equal to 50 mg q.d.,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kaul', 'Affiliation': 'Novartis Institutes for Biomedical Research, Basel, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'End', 'Affiliation': 'Novartis Institutes for Biomedical Research, Basel, Switzerland.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Cabanski', 'Affiliation': 'Novartis Institutes for Biomedical Research, Basel, Switzerland.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Schuhler', 'Affiliation': 'GCE Solutions, Basel, Switzerland.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Jakab', 'Affiliation': 'Novartis Institutes for Biomedical Research, Basel, Switzerland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Kistowska', 'Affiliation': 'Novartis Institutes for Biomedical Research, Basel, Switzerland.'}, {'ForeName': 'Arvind', 'Initials': 'A', 'LastName': 'Kinhikar', 'Affiliation': 'Novartis Institutes for Biomedical Research, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Maiolica', 'Affiliation': 'Novartis Institutes for Biomedical Research, Basel, Switzerland.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Sinn', 'Affiliation': 'Early Phase Clinical Unit, Parexel International, Berlin, Germany.'}, {'ForeName': 'Rainard', 'Initials': 'R', 'LastName': 'Fuhr', 'Affiliation': 'Early Phase Clinical Unit, Parexel International, Berlin, Germany.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Cenni', 'Affiliation': 'Novartis Institutes for Biomedical Research, Basel, Switzerland.'}]",Clinical and translational science,['10.1111/cts.13005'] 3101,33834608,"The effects of the oral supplementation of L-Cystine associated with reduced L-Glutathione-GSH on human skin pigmentation: a randomized, double-blinded, benchmark- and placebo-controlled clinical trial.","BACKGROUND Glutathione has become a potential skin-lightening ingredient after the discovery of its anti-melanogenic properties. Various mechanisms of action have been considered to explain this property, one of them being the skewing of the melanin synthesis pathway towards the production of lighter pheomelanin instead of darker eumelanin, consequently producing a lightening effect. AIMS To evaluate the skin lightening and anti-dark spot effects of oral supplementation with L-Cystine associated with L-Glutathione as compared to placebo and benchmark. METHODS Effects of this L-Cystine-L-Glutathione oral combination were investigated in a 12-week randomized, double-blind, parallel-group, benchmark- and placebo-controlled trial involving 124 Asian female subjects. Women were randomly allocated into 4 equal groups (500 mg L-Cystine and 250 mg L-Glutathione, 250 mg reduced L-Glutathione, 500 mg L-Cystine, or a placebo, daily). Skin color was measured at baseline, after 6 and 12 weeks by spectrophotometry. Size and color of facial dark spots were determined from digital photographs. RESULTS A significant skin lightening was observed after 12 weeks of oral supplementation with L-Cystine associated with L-Glutathione. This combination also induced a significant reduction in the size of facial dark spots after 6 and 12 weeks. It is noteworthy that the observed effects were not only significantly better than those obtained with placebo, but also with L-Cystine alone or L-Glutathione alone. CONCLUSION The daily oral administration of 500 mg L-Cystine and 250 mg L-Glutathione during 12 weeks was a safe treatment to effectively lighten the skin and reduce the size of facial dark spots of Asian women.",2021,A significant skin lightening was observed after 12 weeks of oral supplementation with L-Cystine associated with L-Glutathione.,"['124 Asian female subjects', 'Asian women', 'human skin pigmentation']","['L-Cystine-L-Glutathione oral combination', 'L-Cystine and 250 mg L-Glutathione, 250 mg reduced L-Glutathione, 500 mg L-Cystine, or a placebo, daily', '500 mg L-Cystine and 250 mg L-Glutathione', 'placebo', 'oral supplementation of L-Cystine associated with reduced L-Glutathione-GSH', 'oral supplementation with L-Cystine associated with L-Glutathione', 'benchmark- and placebo']","['Skin color', 'size of facial dark spots', 'skin lightening', 'Size and color of facial dark spots']","[{'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3859811', 'cui_str': 'human skin preparation'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}]","[{'cui': 'C0010682', 'cui_str': 'Cystine'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0525063', 'cui_str': 'Best Practice Analysis'}]","[{'cui': 'C0037290', 'cui_str': 'Skin pigmentation'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0332582', 'cui_str': 'Dark color'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C1868997', 'cui_str': 'Skin lightening'}, {'cui': 'C0009393', 'cui_str': 'Color'}]",124.0,0.476417,A significant skin lightening was observed after 12 weeks of oral supplementation with L-Cystine associated with L-Glutathione.,"[{'ForeName': 'Joël', 'Initials': 'J', 'LastName': 'Duperray', 'Affiliation': 'BCF Life Sciences, Pleucadeuc, France.'}, {'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Sergheraert', 'Affiliation': 'BCF Life Sciences, Pleucadeuc, France.'}, {'ForeName': 'Kunyanatt', 'Initials': 'K', 'LastName': 'Chalothorn', 'Affiliation': 'Spincontrol Asia Co., Ltd, Bangkok, Thailand.'}, {'ForeName': 'Preeyanuch', 'Initials': 'P', 'LastName': 'Tachalerdmanee', 'Affiliation': 'Spincontrol Asia Co., Ltd, Bangkok, Thailand.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Perin', 'Affiliation': 'Spincontrol Asia Co., Ltd, Bangkok, Thailand.'}]",Journal of cosmetic dermatology,['10.1111/jocd.14137'] 3102,33834521,"Impact of baricitinib in combination with topical steroids on atopic dermatitis symptoms, quality of life, and functioning in adult patients with moderate-to-severe atopic dermatitis from the BREEZE-AD7 Phase 3 randomised trial.","BACKGROUND Baricitinib is an oral, selective, reversible Janus kinase 1/2 inhibitor approved in the European Union and Japan and under investigation in the United States for treatment of atopic dermatitis (AD). OBJECTIVES To evaluate the impact of baricitinib plus background topical corticosteroids (TCS) on health-related quality of life (HRQoL), how AD symptoms impact work productivity and life functioning, and treatment benefit using patient-reported outcome (PRO) assessments in patients with moderate-to-severe AD previously experiencing inadequate response to TCS. METHODS Adult patients with AD in BREEZE-AD7, a Phase 3, multicentre, double-blind trial, were randomised 1:1:1 to daily oral placebo (control) or baricitinib 4-mg or 2-mg plus TCS. PROs reported Week 1 through Week 16: Dermatology Life Quality Index (DLQI), Work Productivity and Activity Impairment-AD (WPAI-AD); Patient-Reported Outcomes Measurement Information System (PROMIS) Itch and Sleep measures, and Patient Benefit Index (PBI). Data were analysed using logistic regression (categorical) and mixed model repeated measures (continuous). PBI scores were analysed using analysis of variance. RESULTS A total of 329 patients were randomised. Treatment with baricitinib 4-mg (N=111) or 2mg (N=109) plus TCS led to rapid, statistically significant improvements (versus TCS plus placebo [N=109]) in DLQI ≥4-point improvement starting at Week 2 (4-mg plus TCS, p≤.001; 2-mg plus TCS p≤.05), change from baseline in WPAI-AD presenteeism at Week 1 (4-mg plus TCS, p≤.01; 2-mg plus TCS p≤.05), and PROMIS itch interference at Week 2 (4-mg plus TCS p≤.01). Improvements were sustained through Week 16 for baricitinib 4-mg. Statistically significant improvements were observed at Week 16 for PBI global score (4-mg plus TCS, p≤.001; 2-mg plus TCS p≤.05). CONCLUSIONS Baricitinib plus TCS versus placebo plus TCS showed significant improvements in treatment benefit at Week 16 and rapid significant improvements in HRQoL and impact of AD symptoms on work productivity and functioning through 16 weeks.",2021,"Statistically significant improvements were observed at Week 16 for PBI global score (4-mg plus TCS, p≤.001; 2-mg plus TCS p≤.05). ","['adult patients with moderate-to-severe atopic dermatitis', 'patients with moderate-to-severe AD previously experiencing inadequate response to TCS', '329 patients were randomised', 'Adult patients with AD in BREEZE-AD7']","['placebo plus TCS', 'baricitinib', 'baricitinib plus background topical corticosteroids (TCS', 'oral placebo (control) or baricitinib 4-mg or 2-mg plus TCS', 'topical steroids', 'TCS']","['Dermatology Life Quality Index (DLQI), Work Productivity and Activity Impairment-AD', 'PBI scores', 'atopic dermatitis symptoms, quality of life, and functioning', 'PBI global score', 'health-related quality of life (HRQoL', 'Outcomes Measurement Information System (PROMIS) Itch and Sleep measures, and Patient Benefit Index (PBI']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C1853555', 'cui_str': 'Alzheimer Disease 7'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}]","[{'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021428', 'cui_str': 'Information system'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",329.0,0.306358,"Statistically significant improvements were observed at Week 16 for PBI global score (4-mg plus TCS, p≤.001; 2-mg plus TCS p≤.05). ","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wollenberg', 'Affiliation': 'Department of Dermatology and Allergy, Ludwig Maximillian University, Munich, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Nakahara', 'Affiliation': 'Department of Dermatology, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Maari', 'Affiliation': 'Innovaderm Research and Montreal University, Division of Dermatology, Montreal, Quebec, Canada.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Peris', 'Affiliation': 'Dermatology, Università Cattolica del Sacro Cuore and Fondazione Policlinico Agostino Gemelli - IRCCS, Rome, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lio', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Augustin', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'J I', 'Initials': 'JI', 'LastName': 'Silverberg', 'Affiliation': 'George Washington University School of Medicine and Health Sciences, Washington, DC, USA.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Rueda', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, United States.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'DeLozier', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, United States.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Pierce', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, United States.'}, {'ForeName': 'F E', 'Initials': 'FE', 'LastName': 'Yang', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, United States.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, United States.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ball', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, United States.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tauber', 'Affiliation': 'Toulouse University and CHU Larrey, Toulouse, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Paul', 'Affiliation': 'Toulouse University and CHU Larrey, Toulouse, France.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.17278'] 3103,33834505,"Effectiveness of a nurse-led, face-to-face health coaching intervention in enhancing activation and secondary outcomes of primary care users with chronic conditions.","Prevalence of chronic diseases and multimorbidity is rising, and it remains unclear what the best strategy is for activating people with chronic conditions in their self-care. We designed a two-group quasi-experimental time series trial to examine the effectiveness of a nurse-led, face-to-face, individually-tailored health coaching (HC) intervention in improving patient activation and secondary outcomes (self-efficacy, quality of life, anxiety and depression symptoms, medication adherence, hospitalization and emergency visits) among primary care users with chronic conditions. A total of 118 people with chronic conditions were recruited through a primary care center and allocated to either the intervention group (IG) (n = 58) or control group (CG) (n = 60). The IG received a nurse-led individually-tailored HC intervention involving 4-6 face-to-face multicomponent sessions covering six core activation topics. The CG received usual primary care. Data were collected at baseline, after the intervention (6 weeks after baseline for controls) and at 6 and 12 months from baseline. Compared with controls, the IG had significantly higher patient activation scores after the intervention (73.29 vs. 66.51, p = .006). However, this improvement was not maintained at follow-up and there were no significant differences in secondary outcomes across the study period. HC may be an effective strategy for achieving short-term improvements in the activation of primary care users with chronic conditions. Further studies with different methodological approaches are needed to elucidate how HC may improve and sustain changes in patient activation.",2021,"However, this improvement was not maintained at follow-up and there were no significant differences in secondary outcomes across the study period.","['118 people with chronic conditions', 'primary care users with chronic conditions']","['nurse-led individually-tailored HC intervention', 'nurse-led, face-to-face, individually-tailored health coaching (HC) intervention', 'intervention group (IG) (n\u2009=\u200958) or control group (CG', 'nurse-led, face-to-face health coaching intervention']","['patient activation scores', 'patient activation and secondary outcomes (self-efficacy, quality of life, anxiety and depression symptoms, medication adherence, hospitalization and emergency visits']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}]",118.0,0.045282,"However, this improvement was not maintained at follow-up and there were no significant differences in secondary outcomes across the study period.","[{'ForeName': 'Cibeles', 'Initials': 'C', 'LastName': 'Moreno-Chico', 'Affiliation': 'Department of Nursing, Faculty of Medicine and Health Sciences, Universitat Internacional de Catalunya, Sant Cugat del Vallès, Barcelona, Spain.'}, {'ForeName': 'Callista', 'Initials': 'C', 'LastName': 'Roy', 'Affiliation': ""Mount Saint Mary's University Los Angeles, Los Angeles, California, USA.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Monforte-Royo', 'Affiliation': 'Department of Nursing, Faculty of Medicine and Health Sciences, Universitat Internacional de Catalunya, Sant Cugat del Vallès, Barcelona, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'González-De Paz', 'Affiliation': ""Les Corts Primary Healthcare Center, Consorci d'Atenció Primària de Salut Barcelona Esquerra, Barcelona, Spain.""}, {'ForeName': 'Maria D', 'Initials': 'MD', 'LastName': 'Navarro-Rubio', 'Affiliation': ""Patient and Family Empowerment, Sant Joan de Deu Children's Hospital, Barcelona, Spain.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Gallart Fernández-Puebla', 'Affiliation': 'Department of Nursing, Faculty of Medicine and Health Sciences, Universitat Internacional de Catalunya, Sant Cugat del Vallès, Barcelona, Spain.'}]",Research in nursing & health,['10.1002/nur.22132'] 3104,33834490,Divesting from a Scored Hospital Fall Risk Assessment Tool (FRAT): A Cluster Randomized Non-Inferiority Trial.,"BACKGROUND/OBJECTIVES We investigated the impact of ceasing routine falls risk assessment tool (FRAT) completion and instead used clinical reasoning to select fall mitigation strategies. DESIGN Two-group, multi-site cluster-randomized active-control non-inferiority trial. SETTING Hospital wards. PARTICIPANTS Adult inpatients admitted to participating hospitals (n = 10 hospitals, 123,176 bed days). INTERVENTION Hospitals were randomly assigned (1:1) to a usual care control group that continued to use a historical FRAT to assign falls risk scores and accompanying mitigation strategies, or an experimental group whereby clinicians did not assign risk scores and instead used clinical reasoning to select fall mitigation strategies using a decision support list. MEASUREMENTS The primary measure was between-group difference in mean fall rates (falls/1000 bed days). Falls were identified from incident reports supplemented by hand searches of medical records over three consecutive months at each hospital. The incidence rate ratio (IRR) of monthly falls rates in control versus experimental hospitals was also estimated. RESULTS The experimental clinical reasoning approach was non-inferior to the usual care FRAT that assigned fall risk ratings when compared to a-priori stakeholder derived and sensitivity non-inferiority margins. The mean fall rates were 3.84 falls/1000 bed days for the FRAT continuing sites and 3.11 falls/1000 bed days for experimental sites. After adjusting for historical fall rates at each hospital, the IRR (95%CI) was 0.78 (0.64, 0.95), where IRR < 1.00 indicated fewer falls among the experimental group. There were 4 and 3 serious events in the control and experimental groups, respectively. CONCLUSION Replacing a FRAT scoring system with clinical reasoning did not lead to inferior fall outcomes in the short term and may even reduce fall incidence.",2021,Replacing a FRAT scoring system with clinical reasoning did not lead to inferior fall outcomes in the short term and may even reduce fall incidence.,"['Adult inpatients admitted to participating hospitals (n = 10 hospitals, 123,176 bed days', 'Hospital wards']","['ceasing routine falls risk assessment tool (FRAT) completion', 'usual care control group that continued to use a historical FRAT to assign falls risk scores and accompanying mitigation strategies, or an experimental group whereby clinicians did not assign risk scores and instead used clinical reasoning to select fall mitigation strategies using a decision support list']","['Hospital Fall Risk Assessment Tool (FRAT', 'mean fall rates', 'incidence rate ratio (IRR) of monthly falls rates']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]","[{'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C1532976', 'cui_str': 'Fall risk assessment'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1532976', 'cui_str': 'Fall risk assessment'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",,0.069411,Replacing a FRAT scoring system with clinical reasoning did not lead to inferior fall outcomes in the short term and may even reduce fall incidence.,"[{'ForeName': 'Meg E', 'Initials': 'ME', 'LastName': 'Morris', 'Affiliation': 'Healthscope ARCH, Victorian Rehabilitation Centre, Glen Waverley, Victoria, Australia.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Haines', 'Affiliation': 'School of Primary and Allied Health Care, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Hill', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Cameron', 'Affiliation': 'John Walsh Centre for Rehabilitation Research, Faculty of Medicine and Health, Kolling Institute, University of Sydney, St. Leonards, New South Wales, Australia.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Healthscope, Melbourne, Victoria, Australia.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Jazayeri', 'Affiliation': 'Healthscope ARCH, Victorian Rehabilitation Centre, Glen Waverley, Victoria, Australia.'}, {'ForeName': 'Biswadev', 'Initials': 'B', 'LastName': 'Mitra', 'Affiliation': 'School of Public Health & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Kiegaldie', 'Affiliation': 'Holmesglen Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ronald I', 'Initials': 'RI', 'LastName': 'Shorr', 'Affiliation': 'Geriatric Research Education and Clinical Center (GRECC), Malcom Randall VAMC, Gainesville, Florida, USA and Department of Epidemiology, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'McPhail', 'Affiliation': 'Australian Centre for Health Services Innovation and Centre for Healthcare Transformation, School of Public Health & Social Work, Faculty of Health, Queensland University of Technology, Brisbane, Queensland, Australia.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.17125'] 3105,33834354,Capsule and Sprinkle Formulations of Lubiprostone Are Not Biologically Similar in Patients with Functional Constipation.,"INTRODUCTION Lubiprostone capsules are approved for managing three different chronic constipation conditions. A ""sprinkle"" formulation may facilitate use in individuals with difficulty swallowing capsules. Our objective was to evaluate the bioequivalence, pharmacokinetics (PK), and bioavailability of lubiprostone sprinkles vs lubiprostone capsules, compared with placebo. METHODS A 1-week randomized, placebo-controlled, double-blinded, bioequivalence study (study 302) and a single-dose PK and bioavailability crossover study (study 304) were conducted. In study 302, 522 subjects with chronic constipation were randomized to lubiprostone sprinkle 24 μg twice daily (BID), lubiprostone capsule 24 μg BID, or placebo. The primary efficacy endpoint was observed spontaneous bowel movement (SBM) counts (equivalence defined as showing the 90% confidence interval [CI] of the ""between-group SBM ratio"" to be contained within 0.8-1.25). Study 304 included two cohorts of healthy volunteers randomized to a single 48-μg lubiprostone dose, sprinkle, or capsule (n = 35) or to a single 48-μg sprinkle dose, in fed or fasted state (n = 14). RESULTS Both lubiprostone formulations significantly improved SBM count (sprinkle, 4.82 ± 3.66, P = 0.002; capsule, 5.74 ± 3.79, P < 0.0001) vs placebo (3.68 ± 2.16), but equivalent efficacy was not demonstrated, with a 90% CI for the SBM count ratio of 0.69-0.95. Quantifiable PK data on lubiprostone were limited; however, overall exposure to the M3 metabolite was approximately 44% higher with sprinkles vs capsules under fasted conditions (geometric mean ratio 1.441 [90% CI, 1.166, 1.782]), and exposure with the sprinkle formulation was 11% lower in the fed state vs the fasted state (geometric mean ratio 0.888 [90% CI, 0.675, 1.168]). Both formulations were generally well tolerated. CONCLUSION Despite the significant improvement in SBM counts vs placebo, the sprinkle formulation did not demonstrate bioequivalence to the capsule formulation in either pharmacodynamic or PK key parameters. TRIAL REGISTRATION Study 302: ClinicalTrials.gov identifier, NCT03097861; https://www.clinicaltrials.gov/ct2/show/NCT03097861 ; Study 304: ClinicalTrials.gov identifier, NCT03010631; https://www.clinicaltrials.gov/ct2/show/NCT03010631 .",2021,"Both lubiprostone formulations significantly improved SBM count (sprinkle, 4.82 ± 3.66, P = 0.002; capsule, 5.74 ± 3.79, P < 0.0001) vs placebo (3.68 ± 2.16), but equivalent efficacy was not demonstrated, with a 90% CI for the SBM count ratio of 0.69-0.95.","['522 subjects with chronic constipation', 'individuals with difficulty swallowing capsules', '302', 'Study 304 included two cohorts of healthy volunteers', 'Patients with Functional Constipation']","['placebo', 'lubiprostone sprinkle 24\xa0μg twice daily (BID), lubiprostone capsule 24\xa0μg BID, or placebo', 'single 48-μg lubiprostone dose, sprinkle, or capsule (n\u2009=\u200935) or to a single 48-μg sprinkle dose, in fed or fasted state']","['equivalent efficacy', 'tolerated', 'overall exposure to the M3 metabolite', 'SBM count', 'bioequivalence, pharmacokinetics (PK), and bioavailability', 'spontaneous bowel movement (SBM) counts (equivalence defined as showing the 90% confidence interval [CI] of the ', 'SBM counts']","[{'cui': 'C4517804', 'cui_str': '522'}, {'cui': 'C0401149', 'cui_str': 'Chronic constipation'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0401146', 'cui_str': 'Constipation - functional'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1684405', 'cui_str': 'lubiprostone'}, {'cui': 'C1720266', 'cui_str': 'Sprinkle'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0342895', 'cui_str': 'Fish-eye disease'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]","[{'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0039789', 'cui_str': 'Equivalencies, Therapeutic'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}]",522.0,0.485426,"Both lubiprostone formulations significantly improved SBM count (sprinkle, 4.82 ± 3.66, P = 0.002; capsule, 5.74 ± 3.79, P < 0.0001) vs placebo (3.68 ± 2.16), but equivalent efficacy was not demonstrated, with a 90% CI for the SBM count ratio of 0.69-0.95.","[{'ForeName': 'Atoya', 'Initials': 'A', 'LastName': 'Adams', 'Affiliation': 'AB Clinical Trials, Las Vegas, NV, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Barish', 'Affiliation': 'Wake Research Associates, Raleigh, NC, USA.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Chen', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Inc., Rockville, MD, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Dennis', 'Affiliation': 'Delricht Research, New Orleans, LA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Krause', 'Affiliation': 'WR-Clinsearch, Chattanooga, TN, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lichtlen', 'Affiliation': 'Sucampo Pharmaceuticals (a Legal Entity of Mallinckrodt Pharmaceuticals), Zug, Switzerland.'}, {'ForeName': 'Taryn', 'Initials': 'T', 'LastName': 'Losch-Beridon', 'Affiliation': 'Sucampo Pharmaceuticals (a Legal Entity of Mallinckrodt Pharmaceuticals), Rockville, MD, USA.'}, {'ForeName': 'Shadreck', 'Initials': 'S', 'LastName': 'Mareya', 'Affiliation': 'Sucampo Pharmaceuticals (a Legal Entity of Mallinckrodt Pharmaceuticals), Rockville, MD, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Schneider', 'Affiliation': 'Precision Clinical Research, Sunrise, FL, USA. jschneider@pcrflorida.com.'}]",Advances in therapy,['10.1007/s12325-021-01707-9'] 3106,33834318,The Impact of Immediate Initiation of Antiretroviral Therapy on Patients' Healthcare Expenditures: A Stepped-Wedge Randomized Trial in Eswatini.,"Immediate initiation of antiretroviral therapy (ART) for all people living with HIV has important health benefits but implications for the economic aspects of patients' lives are still largely unknown. This stepped-wedge cluster-randomized controlled trial aimed to determine the causal impact of immediate ART initiation on patients' healthcare expenditures in Eswatini. Fourteen healthcare facilities were randomly assigned to transition at one of seven time points from the standard of care (ART eligibility below a CD4 count threshold) to the immediate ART for all intervention (EAAA). 2261 patients living with HIV were interviewed over the study period to capture their past-year out-of-pocket healthcare expenditures. In mixed-effects regression models, we found a 49% decrease (RR 0.51, 95% CI 0.36, 0.72, p < 0.001) in past-year total healthcare expenditures in the EAAA group compared to the standard of care, and a 98% (RR 0.02, 95% CI 0.00, 0.02, p < 0.001) decrease in spending on private and traditional healthcare. Despite a higher frequency of HIV care visits for newly initiated ART patients, immediate ART initiation appears to have lowered patients' healthcare expenditures because they sought less care from alternative healthcare providers. This study adds an important economic argument to the World Health Organization's recommendation to abolish CD4-count-based eligibility thresholds for ART.",2021,"In mixed-effects regression models, we found a 49% decrease (RR 0.51, 95% CI 0.36, 0.72, p < 0.001) in past-year total healthcare expenditures in the EAAA group compared to the standard of care, and a 98% (RR 0.02, 95% CI 0.00, 0.02, p < 0.001) decrease in spending on private and traditional healthcare.","[""patients' healthcare expenditures in Eswatini"", ""Patients' Healthcare Expenditures"", '2261 patients living with HIV', 'Fourteen healthcare facilities']","['antiretroviral therapy (ART', 'immediate ART initiation', 'Immediate Initiation\xa0of\xa0Antiretroviral Therapy', 'standard of care (ART eligibility below a\xa0CD4 count\xa0threshold) to the immediate ART for all intervention (EAAA']","['past-year total healthcare expenditures', 'spending on private and traditional healthcare']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0038983', 'cui_str': 'Swaziland'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]",2261.0,0.138803,"In mixed-effects regression models, we found a 49% decrease (RR 0.51, 95% CI 0.36, 0.72, p < 0.001) in past-year total healthcare expenditures in the EAAA group compared to the standard of care, and a 98% (RR 0.02, 95% CI 0.00, 0.02, p < 0.001) decrease in spending on private and traditional healthcare.","[{'ForeName': 'Janina I', 'Initials': 'JI', 'LastName': 'Steinert', 'Affiliation': 'TUM School of Governance, Technical University of Munich, Munich, Germany. Janina.steinert@tum.de.'}, {'ForeName': 'Shaukat', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, USA.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Mafara', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, USA.'}, {'ForeName': 'Cebele', 'Initials': 'C', 'LastName': 'Wong', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, USA.'}, {'ForeName': 'Khudzie', 'Initials': 'K', 'LastName': 'Mlambo', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Hettema', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, USA.'}, {'ForeName': 'Fiona J', 'Initials': 'FJ', 'LastName': 'Walsh', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, USA.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Lejeune', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, USA.'}, {'ForeName': 'Sikhathele', 'Initials': 'S', 'LastName': 'Mazibuko', 'Affiliation': 'Ministry of Health of the Kingdom of Eswatini, Mbabane, Eswatini.'}, {'ForeName': 'Velephi', 'Initials': 'V', 'LastName': 'Okello', 'Affiliation': 'Ministry of Health of the Kingdom of Eswatini, Mbabane, Eswatini.'}, {'ForeName': 'Osondu', 'Initials': 'O', 'LastName': 'Ogbuoji', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, USA.'}, {'ForeName': 'Jan-Walter', 'Initials': 'JW', 'LastName': 'De Neve', 'Affiliation': 'Heidelberg Institute of Global Health, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Vollmer', 'Affiliation': 'Chair of Development Economics, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Bärnighausen', 'Affiliation': 'Heidelberg Institute of Global Health, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Geldsetzer', 'Affiliation': 'Heidelberg Institute of Global Health, University of Heidelberg, Heidelberg, Germany.'}]",AIDS and behavior,['10.1007/s10461-021-03241-9'] 3107,33834293,"Invited Response on: Comment on: ""Botulinum Toxin Type A Injection for Mammoplasty and Abdominoplasty Scar Management: A Split-Scar Double-Blinded Randomized Controlled Study"".",,2021,,['Mammoplasty and Abdominoplasty Scar Management'],['Botulinum Toxin Type A Injection'],[],"[{'cui': 'C0085076', 'cui_str': 'Mammoplasty'}, {'cui': 'C0198542', 'cui_str': 'Repair of abdominal wall'}, {'cui': 'C0556498', 'cui_str': 'Scar management'}]","[{'cui': 'C4060200', 'cui_str': 'Botulinum Toxin Type A Injection [Botox]'}]",[],,0.314281,,"[{'ForeName': 'Robabeh', 'Initials': 'R', 'LastName': 'Abedini', 'Affiliation': 'Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Vahdate Eslami Street, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Nasimi', 'Affiliation': 'Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Vahdate Eslami Street, Tehran, Iran. Nsm.maryam@gmail.com.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Mehdizade Rayeni', 'Affiliation': 'Dermatology resident, Razi Hospital, Tehran University of Medical Sciences, Vahdate Eslami Street, Tehran, Iran.'}]",Aesthetic plastic surgery,['10.1007/s00266-021-02265-9'] 3108,33834213,Use of Model-Based Compartmental Analysis and Theoretical Data to Further Explore Choice of Sampling Time for Assessing Vitamin A Status in Groups and Individual Human Subjects by the Retinol Isotope Dilution Method.,"BACKGROUND An optimal blood sampling time for application of the retinol isotope dilution (RID) method for predicting vitamin A total body stores (TBS) (i.e., vitamin A status) has not been established. OBJECTIVES Objectives were to identify sampling times that provide accurate estimates of TBS by RID in groups and individuals by applying compartmental modeling to data for theoretical adults and children. METHODS We selected previously generated hypothetical adults and children (20 per group) that had a wide range of assigned values for TBS and vitamin A kinetic parameters. We used the Simulation, Analysis and Modeling software to simulate individual kinetic responses; then we calculated geometric mean values for the RID equation coefficients and each individual's plasma retinol specific activity at various times, using those values to predict group mean and individual subject TBS. Predicted values for TBS were compared with assigned values. RESULTS Accurate estimates of group mean TBS were obtained at all sampling times from 1 to 30 d in both adults and children. For individuals, correlations between RID-predicted TBS and assigned values increased with time in the adults (R2 = 0.80 at day 14, 0.96 at day 21, and 0.99 at day 28); a similar trend was observed for the children, with R2 = 0.82 at day 7 and increasing to 0.97 at days 21 and 28 (P < 0.001 for all comparisons). CONCLUSIONS Although no single, unique time provided the most accurate prediction of TBS for all individuals within these groups, applying the RID method at 21 or 28 d yielded predictions that were within 25% of assigned values for 90% or 95% of adults, respectively; corresponding values for children were 80% from 10 to 20 d, and 85% at 21 and 28 d. For most subjects, early times (<14 d for adults and <10 d for children) provided less accurate predictions.",2021,"RESULTS Accurate estimates of group mean TBS were obtained at all sampling times from 1 to 30 d in both adults and children.",['hypothetical adults and children (20 per group) that had a wide range of assigned values for TBS and vitamin A kinetic parameters'],[],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",[],[],,0.0809122,"RESULTS Accurate estimates of group mean TBS were obtained at all sampling times from 1 to 30 d in both adults and children.","[{'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Green', 'Affiliation': 'Department of Nutritional Sciences, College of Health and Human Development, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Joanne Balmer', 'Initials': 'JB', 'LastName': 'Green', 'Affiliation': 'Department of Nutritional Sciences, College of Health and Human Development, The Pennsylvania State University, University Park, PA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxab061'] 3109,33833401,A large-scale genome-wide gene expression analysis in peripheral blood identifies very few differentially expressed genes related to antidepressant treatment and response in patients with major depressive disorder.,"A better understanding of the biological factors underlying antidepressant treatment in patients with major depressive disorder (MDD) is needed. We perform gene expression analyses and explore sources of variability in peripheral blood related to antidepressant treatment and treatment response in patients suffering from recurrent MDD at baseline and after 8 weeks of treatment. The study includes 281 patients, which were randomized to 8 weeks of treatment with vortioxetine (N = 184) or placebo (N = 97). To our knowledge, this is the largest dataset including both gene expression in blood and placebo-controlled treatment response measured by a clinical scale in a randomized clinical trial. We identified three novel genes whose RNA expression levels at baseline and week 8 are significantly (FDR < 0.05) associated with treatment response after 8 weeks of treatment. Among these genes were SOCS3 (FDR = 0.0039) and PROK2 (FDR = 0.0028), which have previously both been linked to depression. Downregulation of these genes was associated with poorer treatment response. We did not identify any genes that were differentially expressed between placebo and vortioxetine groups at week 8 or between baseline and week 8 of treatment. Nor did we replicate any genes identified in previous peripheral blood gene expression studies examining treatment response. Analysis of genome-wide expression variability showed that type of treatment and treatment response explains very little of the variance, a median of <0.0001% and 0.05% in gene expression across all genes, respectively. Given the relatively large size of the study, the limited findings suggest that peripheral blood gene expression might not be the best approach to explore the biological factors underlying antidepressant treatment.",2021,We did not identify any genes that were differentially expressed between placebo and vortioxetine groups at week 8 or between baseline and week 8 of treatment.,"['281 patients', 'patients with major depressive disorder (MDD', 'patients with major depressive disorder', 'patients suffering from recurrent MDD at baseline and after 8 weeks of treatment']","['placebo', 'vortioxetine', 'SOCS3']",['RNA expression levels'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0154409', 'cui_str': 'Recurrent major depressive episodes'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3661282', 'cui_str': 'vortioxetine'}]","[{'cui': 'C0040649', 'cui_str': 'Genetic transcription'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",281.0,0.0307615,We did not identify any genes that were differentially expressed between placebo and vortioxetine groups at week 8 or between baseline and week 8 of treatment.,"[{'ForeName': 'Anne Krogh', 'Initials': 'AK', 'LastName': 'Nøhr', 'Affiliation': 'The Bioinformatics Centre, Department of Biology, University of Copenhagen, Copenhagen N, Denmark. anne.nohr@bio.ku.dk.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Lindow', 'Affiliation': 'H. Lundbeck A/S, Valby, Copenhagen, Denmark.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Forsingdal', 'Affiliation': 'H. Lundbeck A/S, Valby, Copenhagen, Denmark.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Demharter', 'Affiliation': 'H. Lundbeck A/S, Valby, Copenhagen, Denmark.'}, {'ForeName': 'Troels', 'Initials': 'T', 'LastName': 'Nielsen', 'Affiliation': 'H. Lundbeck A/S, Valby, Copenhagen, Denmark.'}, {'ForeName': 'Raimund', 'Initials': 'R', 'LastName': 'Buller', 'Affiliation': 'H. Lundbeck A/S, Valby, Copenhagen, Denmark.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Moltke', 'Affiliation': 'The Bioinformatics Centre, Department of Biology, University of Copenhagen, Copenhagen N, Denmark.'}, {'ForeName': 'Morana', 'Initials': 'M', 'LastName': 'Vitezic', 'Affiliation': 'H. Lundbeck A/S, Valby, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Albrechtsen', 'Affiliation': 'The Bioinformatics Centre, Department of Biology, University of Copenhagen, Copenhagen N, Denmark.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-021-01002-9'] 3110,33833379,One-year outcomes after treatment with a drug-coated balloon catheter system for lower urinary tract symptoms related to benign prostatic hyperplasia.,"BACKGROUND This is the first report of the 1-year outcomes of the EVEREST-I study evaluating the safety and efficacy of the Optilume ® BPH Catheter System, a prostatic paclitaxel-coated balloon catheter system, for the treatment of lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH). METHODS Subjects were men >50 years old with moderate-to-severe LUTS secondary to BPH, peak urinary flow rate of 5-15 ml/s, prostatic urethra length 30-55 mm, and prostate volume 20-80 g. All were treated with the Optilume BPH Catheter System and followed at Foley removal, 2 weeks, 30 days, 3, 6, and 12 months after treatment. The primary endpoint was the proportion of subjects with ≥40% improvement in International Prostate Symptom Score (IPSS). The rate of post-procedural complications was evaluated. RESULTS Eighty subjects were treated at six sites in Latin America and 75 completed the 1-year follow-up. The percent of subjects with an improvement ≥40% in IPSS from baseline was 81% at 3 months and 1 year. IPSS improved from 22.3 at baseline to 7.9 at 1 year, Qmax improved from 10.9 to 18.4 ml/s, and IPSS QoL improved from 4.6 to 1.3. Post-procedural complications included common urologic events and the rate of complications was significantly impacted by device diameter. CONCLUSIONS Treatment with the minimally invasive Optilume BPH Catheter System is safe and showed subjective and objective improvements in LUTS. Benefits were rapid and persisted through 1 year. The initial results warrant further evaluation of this therapy as a treatment option for patients with LUTS related to BPH.",2021,"CONCLUSIONS Treatment with the minimally invasive Optilume BPH Catheter System is safe and showed subjective and objective improvements in LUTS.","['lower urinary tract symptoms', 'Subjects were men >50 years old with moderate-to-severe LUTS secondary to BPH, peak urinary flow rate of 5-15\u2009ml/s, prostatic urethra length 30-55\u2009mm, and prostate volume 20-80\u2009g. All were treated with the', 'Eighty subjects were treated at six sites in Latin America and 75 completed the 1-year follow-up', 'patients with LUTS related to BPH']","['EVEREST', 'drug-coated balloon catheter system', 'Optilume ® BPH Catheter System, a prostatic paclitaxel-coated balloon catheter system', 'Optilume BPH Catheter System']","['Qmax', 'rate of post-procedural complications', 'safety and efficacy', 'proportion of subjects with ≥40% improvement in International Prostate Symptom Score (IPSS', 'rate of complications', 'IPSS QoL', 'IPSS']","[{'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429783', 'cui_str': 'Urinary flow rate'}, {'cui': 'C0439390', 'cui_str': 'mL/s'}, {'cui': 'C0458450', 'cui_str': 'Prostatic urethra structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0023122', 'cui_str': 'Latin America'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0441127', 'cui_str': 'Balloon dilatation catheter'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C1141930', 'cui_str': 'Post procedural complication'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",80.0,0.0624465,"CONCLUSIONS Treatment with the minimally invasive Optilume BPH Catheter System is safe and showed subjective and objective improvements in LUTS.","[{'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Kaplan', 'Affiliation': 'Department of Urology, Icahn School of Medicine at Mount Sinai, New York City, NY, USA. steven.kaplan@mountsinai.org.'}, {'ForeName': 'Merycarla', 'Initials': 'M', 'LastName': 'Pichardo', 'Affiliation': 'URUS, Santo Domingo, Dominican Republic.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Rijo', 'Affiliation': 'Centro Médico Dr. Canela SRL, La Romana, Dominican Republic.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Espino', 'Affiliation': 'Centro Especializado San Fernando, Panama City, Panama.'}, {'ForeName': 'Ramon Rodriguez', 'Initials': 'RR', 'LastName': 'Lay', 'Affiliation': 'Edificio Royal Center, Panama City, Panama.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Estrella', 'Affiliation': 'Clínica Unión Medica, Santiago de los Caballeros, Dominican Republic.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-021-00362-z'] 3111,33833378,What is the effect of MRI with targeted biopsies on the rate of patients discontinuing active surveillance? A reflection of the use of MRI in the PRIAS study.,"BACKGROUND The reduction of overtreatment by active surveillance (AS) is limited in patients with low-risk prostate cancer (PCa) due to high rates of patients switching to radical treatment. MRI improves biopsy accuracy and could therewith affect inclusion in or continuation of AS. We aim to assess the effect of MRI with target biopsies on the total rate of patients discontinuing AS, and in particular discontinuation due to Grade Group (GG) reclassification. METHODS Three subpopulations included in the prospective PRIAS study with GG 1 were studied. Group A consists of patients diagnosed before 2009 without MRI before or during AS. Group B consists of patients diagnosed without MRI, but all patients underwent MRI within 6 months after diagnosis. Group C consists of patients who underwent MRI before diagnosis and during follow-up. We used cumulative incidence curves to estimate the rates of discontinuation. RESULTS In Group A (n = 500), the cumulative probability of discontinuing AS at 2 years is 27.5%; GG reclassification solely accounted for 6.9% of the discontinuation. In Group B (n = 351) these numbers are 30.9 and 22.8%, and for Group C (n = 435) 24.2 and 13.4%. The three groups were not randomized, however, baseline characteristics are highly comparable. CONCLUSIONS Performing an MRI before starting AS reduces the cumulative probability of discontinuing AS at 2 years. Performing an MRI after already being on AS increases the cumulative probability of discontinuing AS in comparison to not performing an MRI, especially because of an increase in GG reclassification. These results suggest that the use of MRI could lead to more patients being considered unsuitable for AS. Considering the excellent long-term cancer-specific survival of AS before the MRI era, the increased diagnostic accuracy of MRI could potentially lead to more overtreatment if definitions and treatment options of significant PCa are not adapted.",2021,"Performing an MRI after already being on AS increases the cumulative probability of discontinuing AS in comparison to not performing an MRI, especially because of an increase in GG reclassification.","['Three subpopulations included in the prospective PRIAS study with GG 1 were studied', 'patients with low-risk prostate cancer (PCa', 'patients discontinuing AS, and in particular discontinuation due to Grade Group (GG) reclassification']",['MRI'],"['biopsy accuracy', 'cumulative probability', 'cumulative probability of discontinuing AS']","[{'cui': 'C1257890', 'cui_str': 'Group'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332326', 'cui_str': 'Gleason grading system for prostatic cancer'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}]",,0.0417329,"Performing an MRI after already being on AS increases the cumulative probability of discontinuing AS in comparison to not performing an MRI, especially because of an increase in GG reclassification.","[{'ForeName': 'H B', 'Initials': 'HB', 'LastName': 'Luiting', 'Affiliation': 'Department of Urology, Erasmus University Medical Centre Cancer Institute, Rotterdam, The Netherlands. h.luiting@erasmusmc.nl.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Remmers', 'Affiliation': 'Department of Urology, Erasmus University Medical Centre Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Valdagni', 'Affiliation': 'Department of Oncology and Haemato-oncology, Università degli Studi di Milano. Radiation Oncology 1, Prostate Cancer Program, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'E R', 'Initials': 'ER', 'LastName': 'Boevé', 'Affiliation': 'Department of Urology, Sint Franciscus Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Staerman', 'Affiliation': 'Department of Urology, Polycliniques REIMS-BEZANNES, Reims, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Rueb', 'Affiliation': 'Department of Urology, Marien Hospital Herne, Herne, Germany.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Somford', 'Affiliation': 'Department of Urology, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Pickles', 'Affiliation': 'Department of Radiation Oncology, Vancouver Center, BC Cancer, Vancouver, BC, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rannikko', 'Affiliation': 'Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Roobol', 'Affiliation': 'Department of Urology, Erasmus University Medical Centre Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Prostate cancer and prostatic diseases,['10.1038/s41391-021-00343-2'] 3112,33833225,Spontaneous and deliberate creative cognition during and after psilocybin exposure.,"Creativity is an essential cognitive ability linked to all areas of our everyday functioning. Thus, finding a way to enhance it is of broad interest. A large number of anecdotal reports suggest that the consumption of psychedelic drugs can enhance creative thinking; however, scientific evidence is lacking. Following a double-blind, placebo-controlled, parallel-group design, we demonstrated that psilocybin (0.17 mg/kg) induced a time- and construct-related differentiation of effects on creative thinking. Acutely, psilocybin increased ratings of (spontaneous) creative insights, while decreasing (deliberate) task-based creativity. Seven days after psilocybin, number of novel ideas increased. Furthermore, we utilized an ultrahigh field multimodal brain imaging approach, and found that acute and persisting effects were predicted by within- and between-network connectivity of the default mode network. Findings add some support to historical claims that psychedelics can influence aspects of the creative process, potentially indicating them as a tool to investigate creativity and subsequent underlying neural mechanisms. Trial NL6007; psilocybin as a tool for enhanced cognitive flexibility; https://www.trialregister.nl/trial/6007 .",2021,"Acutely, psilocybin increased ratings of (spontaneous) creative insights, while decreasing (deliberate) task-based creativity.",[],"['placebo', 'psilocybin']","['Spontaneous and deliberate creative cognition', 'ratings of (spontaneous) creative insights, while decreasing (deliberate) task-based creativity']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0033850', 'cui_str': 'Psilocybine'}]","[{'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0233820', 'cui_str': 'Insight'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010297', 'cui_str': 'Creative thought'}]",,0.128525,"Acutely, psilocybin increased ratings of (spontaneous) creative insights, while decreasing (deliberate) task-based creativity.","[{'ForeName': 'N L', 'Initials': 'NL', 'LastName': 'Mason', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands. natasha.mason@maastrichtuniversity.nl.'}, {'ForeName': 'K P C', 'Initials': 'KPC', 'LastName': 'Kuypers', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'J T', 'Initials': 'JT', 'LastName': 'Reckweg', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Müller', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'D H Y', 'Initials': 'DHY', 'LastName': 'Tse', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Da Rios', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'S W', 'Initials': 'SW', 'LastName': 'Toennes', 'Affiliation': 'Institute of Legal Medicine, University of Frankfurt, Kennedyallee 104, D-60596, Frankfurt/Main, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Stiers', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Feilding', 'Affiliation': 'The Beckley Foundation, Beckley Park, Oxford, OX3 9SY, UK.'}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Ramaekers', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands. j.ramaekers@maastrichtuniversity.nl.'}]",Translational psychiatry,['10.1038/s41398-021-01335-5'] 3113,33833190,ActiGraph and Short-term Heart Rate Variability Study Protocol: Amended for the COVID-19 Pandemic.,"BACKGROUND ActiGraph accelerometry is widely used in nursing research to estimate daily physical activity. Heart rate variability (HRV), a measure of autonomic modulation, can be assessed in conjunction with the ActiGraph using a Polar H7 Bluetooth heart rate monitor. There is a paucity of nursing literature to guide nurse researchers' protocol development when using the ActiGraph to assess both physical activity and short-term HRV via its Bluetooth capabilities. OBJECTIVES The aim of this study was to describe a standardized research ActiGraph and HRV (ActiGraph HRV) protocol for an ongoing randomized controlled trial to measure physical activity and short-term HRV in patients with ischemic heart disease who report hopelessness. METHODS We outline the study protocol for the standardization of reliable and rigorous physical activity and HRV data collection using the ActiGraph wGT3X-BT and Polar H7 Bluetooth heart rate monitor, and data analysis using ActiLife and Kubios software programs. RESULTS Sixty-four participants enrolled in the randomized controlled trial to date, and 45 (70.3%) have completed or are actively participating in the study. Heart rate variability data have been collected on 43 of the 45 participants (96%) to date. During the first data collection time point, 42 of 44 participants (95.5%) wore the ActiGraph for a minimum of 5 valid days, followed by 28 of 31 participants (90.3%) and 25 of 26 participants (96.2%) at subsequent data collection time points. The intraclass correlation for physical activity in this study is 0.95 and 0.98 for HRV. DISCUSSION Revisions to the protocol were successfully implemented at the onset of the COVID-19 pandemic for data collection using social distancing. The protocol was additionally amended in response to an unanticipated problem with ActiGraph battery life using Bluetooth technology. Use of the ActiGraph HRV protocol has led to a reliable and rigorous measurement of physical activity and HRV for patients with ischemic heart disease who report hopelessness in this randomized controlled trial. CONCLUSION We provide an ActiGraph HRV protocol that can be adapted as a model in the development of ActiGraph HRV protocols for future nursing research in community and home-based settings while maximizing social distancing in the current and future pandemics.",2021,"Use of the ActiGraph HRV protocol has led to a reliable and rigorous measurement of physical activity and HRV for patients with ischemic heart disease who report hopelessness in this randomized controlled trial. ","['Sixty-four participants enrolled in the randomized controlled trial to date, and 45 (70.3%) have completed or are actively participating in the study', 'patients with ischemic heart disease who report hopelessness']","['physical activity and short-term HRV', 'standardized research ActiGraph and HRV (ActiGraph HRV) protocol', 'ActiGraph HRV protocol']","['Heart rate variability (HRV), a measure of autonomic modulation', 'physical activity']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0150041', 'cui_str': 'Feeling hopeless'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",64.0,0.162854,"Use of the ActiGraph HRV protocol has led to a reliable and rigorous measurement of physical activity and HRV for patients with ischemic heart disease who report hopelessness in this randomized controlled trial. ","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Luong', 'Affiliation': 'Anna Luong, BSN, RN PhD Student, Department of Biobehavioral Nursing Science, College of Nursing, University of Illinois at Chicago. Madison Goodyke, BSN, RN PhD Student, Department of Biobehavioral Nursing Science, College of Nursing, University of Illinois at Chicago. Susan L. Dunn, PhD, RN, FAHA, FAAN Associate Professor and Department Head, Department of Biobehavioral Nursing Science, College of Nursing, University of Illinois at Chicago. Tracy Baynard, PhD, MS Associate Professor and Director, Department of Kinesiology and Nutrition, College of Applied Health Sciences, University of Illinois at Chicago. Ulf Bronas, PhD, ATC, FSVM, FAHA Associate Professor, Department of Biobehavioral Nursing Science, College of Nursing, University of Illinois at Chicago.'}, {'ForeName': 'Madison', 'Initials': 'M', 'LastName': 'Goodyke', 'Affiliation': ''}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Dunn', 'Affiliation': ''}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Baynard', 'Affiliation': ''}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Bronas', 'Affiliation': ''}]",The Journal of cardiovascular nursing,['10.1097/JCN.0000000000000817'] 3114,33833151,The effect of fluoxetine on morning blood pressure surge in patients with ischemic stroke: a prospective preliminary clinical study.,"OBJECTIVE Our study aimed to evaluate the effect of fluoxetine on morning blood pressure surge (MBPS) in patients with ischemic stroke. METHODS A total of 30 patients with acute ischemic stroke, 15 in the control group and 15 in the treatment group, were enrolled. Two patients in the control group and one in the treatment group were lost during follow-up. The patients in the treatment group were treated with fluoxetine (20 mg per day for 3 months) based on the treatments in the control group. Baseline characteristics, Patient Health Questionnaire 9 (PHQ-9) items scale score, mean blood pressure and MBPS were evaluated before and after treatment, and the correlation between the improvements of PHQ-9 scale score and MBPS was also analyzed. RESULTS The mean SBP and the systolic and diastolic MBPS in the treatment group were significantly lower than that in the control group after 3 months of treatment (P = 0.024, P = 0.022, P = 0.001, respectively). Besides, the improvement of PHQ-9 scale score was significantly higher in the treatment group than in the control group (P = 0.049). There was no significant correlation between the improvement of systolic or diastolic MBPS and the improvement of PHQ-9 scale score in the treatment group (P = 0.289 and P = 0.206, respectively). CONCLUSION Fluoxetine might improve MBPS in patients with ischemic stroke.",2021,"The mean SBP and the systolic and diastolic MBPS in the treatment group were significantly lower than that in the control group after 3 months of treatment (P = 0.024, P = 0.022, P = 0.001, respectively).","['patients with ischemic stroke', '30 patients with acute ischemic stroke, 15 in the control group and 15 in the treatment group, were enrolled']","['fluoxetine', 'Fluoxetine']","['MBPS', 'systolic or diastolic MBPS', 'morning blood pressure surge', 'PHQ-9 scale score', 'PHQ-9 scale score and MBPS', 'morning blood pressure surge (MBPS', 'mean SBP and the systolic and diastolic MBPS', 'Baseline characteristics, Patient Health Questionnaire 9 (PHQ-9) items scale score, mean blood pressure and MBPS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0016365', 'cui_str': 'Fluoxetine'}]","[{'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",30.0,0.029849,"The mean SBP and the systolic and diastolic MBPS in the treatment group were significantly lower than that in the control group after 3 months of treatment (P = 0.024, P = 0.022, P = 0.001, respectively).","[{'ForeName': 'Yitao', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': ""Department of Neurology, The Second Clinical Medical College of Jinan University (Shenzhen People's Hospital; The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen, Guangdong, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Deng', 'Affiliation': ''}, {'ForeName': 'Yaqing', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Zhili', 'Initials': 'Z', 'LastName': 'Cai', 'Affiliation': ''}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': ''}]",Blood pressure monitoring,['10.1097/MBP.0000000000000538'] 3115,33833090,Motivational Interviewing Enhances Group Cognitive Behavioral Therapy for Anxiety Disorders.,"This pilot study tested whether the addition of motivational interviewing (MI) prior to group cognitive behavioral therapy (CBT) for anxiety may improve the effectiveness of the treatment. Prior to group CBT, 40 individuals with a principal diagnosis of an anxiety disorder (40% panic disorder, 25% generalized anxiety disorder, 22.5% social phobia, and 12.5% others) were randomly assigned to receive either three individual sessions of MI or were assigned to a control group that did not receive MI. The pretreatment MI group, compared to the control group, experienced significantly greater reduction in anxiety symptoms post-CBT. These results suggest that brief MI pretreatment enhances the efficacy of CBT on anxiety. A combination of MI and CBT may be particularly promising for the treatment of anxiety, with MI directed at increasing motivation and commitment to change, and CBT directed at helping the client achieve the desired changes.",2021,"The pretreatment MI group, compared to the control group, experienced significantly greater reduction in anxiety symptoms post-CBT.","['40 individuals with a principal diagnosis of an anxiety disorder (40% panic disorder, 25% generalized anxiety disorder, 22.5% social phobia, and 12.5% others', 'Anxiety Disorders']","['MI and CBT', 'motivational interviewing (MI) prior to group cognitive behavioral therapy (CBT', 'control group that did not receive MI', 'Motivational Interviewing Enhances Group Cognitive Behavioral Therapy']","['efficacy of CBT on anxiety', 'anxiety symptoms post-CBT']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4517649', 'cui_str': '22.5'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C4517544', 'cui_str': '12.5'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0687676', 'cui_str': 'After values'}]",40.0,0.0122749,"The pretreatment MI group, compared to the control group, experienced significantly greater reduction in anxiety symptoms post-CBT.","[{'ForeName': 'Esben', 'Initials': 'E', 'LastName': 'Strodl', 'Affiliation': 'School of Psychology and Counselling, Queensland University of Technology, Brisbane, Queensland, Australia e.strodl@qut.edu.au.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'School of Psychology and Counselling, Queensland University of Technology, Brisbane, Queensland, Australia.'}]",Journal of cognitive psychotherapy,['10.1891/JCPSY-D-20-00025'] 3116,33832998,"Characteristics of Veterans With Non-VA Encounters Enrolled in a Trial of Standards-Based, Interoperable Event Notification and Care Coordination.","INTRODUCTION Understanding how veterans use Veterans Affairs (VA) for primary care and non-VA for acute care can help policy makers predict future health care resource use. We aimed to describe characteristics of veterans enrolled in a multisite clinical trial of non-VA acute event notifications and care coordination and to identify patient factors associated with non-VA acute care. METHODS Characteristics of 565 veterans enrolled in a prospective cluster randomized trial at the Bronx and Indianapolis VA Medical Centers were obtained by interview and chart review. RESULTS Veterans' mean age was 75.8 years old, 98.3% were male, and 39.2% self-identified as a minority race; 81.2% reported receiving the majority of care at the VA. There were 197 (34.9%) veterans for whom a non-VA acute care alert was received. Patient characteristics significantly associated with greater odds of a non-VA alert included older age (OR = 1.05; 95% CI, 1.04-1.05); majority of care received is non-VA (OR = 1.83; 95% CI, 1.06-3.15); private insurance (OR = 1.39; 95% CI, 1.19-1.62); and higher income (OR = 4.01; 95% CI, 2.68-5.98). CONCLUSIONS We identified several patient-level factors associated with non-VA acute care that can inform the design of VA services and policies for veterans with non-VA acute care encounters and reintegration back into the VA system.",2021,"Patient characteristics significantly associated with greater odds of a non-VA alert included older age (OR = 1.05; 95% CI, 1.04-1.05); majority of care received is non-VA (OR = 1.83; 95% CI, 1.06-3.15); private insurance (OR = 1.39; 95% CI, 1.19-1.62); and higher income (OR = 4.01; 95% CI, 2.68-5.98). ","['Characteristics of 565 veterans enrolled in a prospective cluster randomized trial at the Bronx and Indianapolis VA Medical Centers were obtained by interview and chart review', ""Veterans' mean age was 75.8 years old, 98.3% were male, and 39.2% self-identified as a minority race; 81.2% reported receiving the majority of care at the VA"", 'Veterans With Non-VA Encounters Enrolled in a Trial of Standards']",[],[],"[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0541653', 'cui_str': 'Chart evaluation by healthcare professional'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",[],[],565.0,0.107328,"Patient characteristics significantly associated with greater odds of a non-VA alert included older age (OR = 1.05; 95% CI, 1.04-1.05); majority of care received is non-VA (OR = 1.83; 95% CI, 1.06-3.15); private insurance (OR = 1.39; 95% CI, 1.19-1.62); and higher income (OR = 4.01; 95% CI, 2.68-5.98). ","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Kartje', 'Affiliation': 'From the Richard L. Roudebush VA Medical Center, U.S. Department of Veterans Affairs, Indianapolis, IN (RK, BED, ALS, JCY); IU Fairbanks School of Public Health, Indianapolis, IN (BED); Regenstrief Institute, Indianapolis, IN (BED): James J. Peters VA Medical Center, U.S. Department of Veterans Affairs, Bronx, NY (VG, KMJ, KB); Icahn School of Medicine at Mount Sinai, New York, NY (KB). rebecca.kartje@va.gov.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Dixon', 'Affiliation': 'From the Richard L. Roudebush VA Medical Center, U.S. Department of Veterans Affairs, Indianapolis, IN (RK, BED, ALS, JCY); IU Fairbanks School of Public Health, Indianapolis, IN (BED); Regenstrief Institute, Indianapolis, IN (BED): James J. Peters VA Medical Center, U.S. Department of Veterans Affairs, Bronx, NY (VG, KMJ, KB); Icahn School of Medicine at Mount Sinai, New York, NY (KB).'}, {'ForeName': 'Ashley L', 'Initials': 'AL', 'LastName': 'Schwartzkopf', 'Affiliation': 'From the Richard L. Roudebush VA Medical Center, U.S. Department of Veterans Affairs, Indianapolis, IN (RK, BED, ALS, JCY); IU Fairbanks School of Public Health, Indianapolis, IN (BED); Regenstrief Institute, Indianapolis, IN (BED): James J. Peters VA Medical Center, U.S. Department of Veterans Affairs, Bronx, NY (VG, KMJ, KB); Icahn School of Medicine at Mount Sinai, New York, NY (KB).'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Guerrero', 'Affiliation': 'From the Richard L. Roudebush VA Medical Center, U.S. Department of Veterans Affairs, Indianapolis, IN (RK, BED, ALS, JCY); IU Fairbanks School of Public Health, Indianapolis, IN (BED); Regenstrief Institute, Indianapolis, IN (BED): James J. Peters VA Medical Center, U.S. Department of Veterans Affairs, Bronx, NY (VG, KMJ, KB); Icahn School of Medicine at Mount Sinai, New York, NY (KB).'}, {'ForeName': 'Kimberly M', 'Initials': 'KM', 'LastName': 'Judon', 'Affiliation': 'From the Richard L. Roudebush VA Medical Center, U.S. Department of Veterans Affairs, Indianapolis, IN (RK, BED, ALS, JCY); IU Fairbanks School of Public Health, Indianapolis, IN (BED); Regenstrief Institute, Indianapolis, IN (BED): James J. Peters VA Medical Center, U.S. Department of Veterans Affairs, Bronx, NY (VG, KMJ, KB); Icahn School of Medicine at Mount Sinai, New York, NY (KB).'}, {'ForeName': 'Joanne C', 'Initials': 'JC', 'LastName': 'Yi', 'Affiliation': 'From the Richard L. Roudebush VA Medical Center, U.S. Department of Veterans Affairs, Indianapolis, IN (RK, BED, ALS, JCY); IU Fairbanks School of Public Health, Indianapolis, IN (BED); Regenstrief Institute, Indianapolis, IN (BED): James J. Peters VA Medical Center, U.S. Department of Veterans Affairs, Bronx, NY (VG, KMJ, KB); Icahn School of Medicine at Mount Sinai, New York, NY (KB).'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Boockvar', 'Affiliation': 'From the Richard L. Roudebush VA Medical Center, U.S. Department of Veterans Affairs, Indianapolis, IN (RK, BED, ALS, JCY); IU Fairbanks School of Public Health, Indianapolis, IN (BED); Regenstrief Institute, Indianapolis, IN (BED): James J. Peters VA Medical Center, U.S. Department of Veterans Affairs, Bronx, NY (VG, KMJ, KB); Icahn School of Medicine at Mount Sinai, New York, NY (KB).'}]",Journal of the American Board of Family Medicine : JABFM,['10.3122/jabfm.2021.02.200251'] 3117,33832979,"Lateral tenodesis procedures increase lateral compartment pressures more than anterolateral ligament reconstruction, when performed in combination with ACL reconstruction: a pilot biomechanical study.","OBJECTIVES Given the common occurrence of residual laxity and re-injury post anterior cruciate ligament reconstruction (ACLR), additional anterolateral procedures are increasingly used in combination with an ACLR. Despite the perception that there is a risk of over-constraining the lateral tibiofemoral (LTF) compartment, potentially leading to osteoarthritis, assessment on their effect on intra-articular compartment pressures is still lacking. Our objective was therefore, through a pilot biomechanical study, to compare LTF contact pressures after the most commonly used anterolateral procedures. METHODS A controlled laboratory pilot study was performed using 4 fresh-frozen cadaveric whole lower limbs. Through 0° to 90° of flexion, LTF contact pressures were measured with a Tekscan sensor, located under the lateral meniscus. Knee kinematics were obtained in 3 conditions of rotation (NR: neutral, ER: external and IR: internal rotation) to record the position of the knees for each loading condition. A Motion Analysis system with a coordinate system based on CT scans 3D bone modelling was used. After an ACLR, defined as the reference baseline, 5 anterolateral procedures were compared: anterolateral ligament reconstruction (ALLR), modified Ellison, deep Lemaire, superficial Lemaire and modified MacIntosh procedures. The last 3 procedures were randomised. For each procedure, the graft was fixed in NR at 30° of flexion and with a tension of 20 N. RESULTS Compared with isolated ACLR, addition of either ALLR or modified Ellison procedure did not increased the overall LTF contact pressure (all p>0.05) through the full range of flexion for the IR condition. Conversely, deep Lemaire, superficial Lemaire and modified MacIntosh procedure (all p<0.05) did increase the overall LTF contact pressure compared with ACLR in IR. No significant difference was observed in ER and NR conditions. CONCLUSION This pilot study, comparing the main anterolateral procedures, revealed that addition of either ALLR or modified Ellison procedure did not change the overall contact pressure in the LTF compartment through 0° to 90° of knee flexion. In contrast, the deep and superficial Lemaire, and modified MacIntosh procedures significantly increased overall LTF contact pressures when the knee was internally rotated.",2021,"Conversely, deep Lemaire, superficial Lemaire and modified MacIntosh procedure (all p<0.05) did increase the overall LTF contact pressure compared with ACLR in IR.",['4 fresh-frozen cadaveric whole lower limbs'],"['external and IR: internal rotation', 'ALLR or modified Ellison procedure', 'anterior cruciate ligament reconstruction (ACLR', 'anterolateral ligament reconstruction', 'rotation (NR: neutral, ER']","['overall LTF contact pressure', 'overall LTF contact pressures', 'LTF contact pressures', 'Knee kinematics', 'ER and NR conditions', 'overall contact pressure']","[{'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0332194', 'cui_str': 'Anterolateral'}, {'cui': 'C0547071', 'cui_str': 'Ligament reconstruction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",,0.02741,"Conversely, deep Lemaire, superficial Lemaire and modified MacIntosh procedure (all p<0.05) did increase the overall LTF contact pressure compared with ACLR in IR.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Neri', 'Affiliation': 'Sydney Orthopaedic Research Institute Ltd, Chatswood, New South Wales, Australia thomas.neri@outlook.com.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Cadman', 'Affiliation': 'Faculty of Medicine and Health Sciences, Macquarie University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Beach', 'Affiliation': 'Sydney Orthopaedic Research Institute Ltd, Chatswood, New South Wales, Australia.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Grasso', 'Affiliation': 'Sydney Orthopaedic Research Institute Ltd, Chatswood, New South Wales, Australia.'}, {'ForeName': 'Danè', 'Initials': 'D', 'LastName': 'Dabirrahmani', 'Affiliation': 'Faculty of Medicine and Health Sciences, Macquarie University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Putnis', 'Affiliation': 'Sydney Orthopaedic Research Institute Ltd, Chatswood, New South Wales, Australia.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Oshima', 'Affiliation': 'Sydney Orthopaedic Research Institute Ltd, Chatswood, New South Wales, Australia.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Devitt', 'Affiliation': 'OrthoSport Victoria, Richmond, Victoria, Australia.'}, {'ForeName': 'Myles', 'Initials': 'M', 'LastName': 'Coolican', 'Affiliation': 'Sydney Orthopaedic Research Institute Ltd, Chatswood, New South Wales, Australia.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Fritsch', 'Affiliation': 'Sydney Orthopaedic Research Institute Ltd, Chatswood, New South Wales, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Appleyard', 'Affiliation': 'Faculty of Medicine and Health Sciences, Macquarie University, Sydney, New South Wales, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Parker', 'Affiliation': 'Sydney Orthopaedic Research Institute Ltd, Chatswood, New South Wales, Australia.'}]",Journal of ISAKOS : joint disorders & orthopaedic sports medicine,['10.1136/jisakos-2019-000368'] 3118,33832957,"Efficacy and Safety of Mulberry Twig Alkaloids Tablet for the Treatment of Type 2 Diabetes: A Multicenter, Randomized, Double-Blind, Double-Dummy, and Parallel Controlled Clinical Trial.","OBJECTIVE This study aimed to evaluate the efficacy and safety of mulberry twig alkaloids (Sangzhi alkaloids [SZ-A]) in the treatment of type 2 diabetes (T2D). RESEARCH DESIGN AND METHODS This was a multicenter, randomized, double-blind, double-dummy, and parallel controlled noninferiority clinical trial that was conducted for 24 weeks. A total of 600 patients were randomly allocated to the SZ-A group ( n = 360) or acarbose group ( n = 240). The primary efficacy end point was the change of glycosylated hemoglobin (HbA 1c ) compared with baseline. In addition, adverse events (AEs), severe AEs (SAEs), treatment-related AEs (TAEs), and gastrointestinal disorders (GDs) were monitored. RESULTS After treatment for 24 weeks, the change in HbA 1c was -0.93% (95% CI -1.03 to -0.83) (-10.2 mmol/mol [-11.3 to -9.1]) and -0.87% (-0.99 to -0.76) (-9.5 mmol/mol [-10.8 to -8.3]) in the SZ-A and acarbose groups, respectively, and the least squares mean difference was -0.05% (95% CI -0.18 to 0.07) (-0.5 mmol/mol [-2.0 to 0.8]) between the two groups, with no significant difference on the basis of covariance analysis ( P > 0.05). The incidence of TAEs and GDs was significantly lower in the SZ-A group than the acarbose group ( P < 0.01), but no differences for AEs or SAEs between the two groups were observed ( P > 0.05). CONCLUSIONS SZ-A exhibited equivalent hypoglycemic effects to acarbose in patients with T2D. Nevertheless, the incidence of TAEs and GDs was lower following SZ-A treatment than acarbose treatment, suggesting good safety.",2021,"The incidence of TAEs and GDs was significantly lower in the SZ-A group than the acarbose group ( P < 0.01), but no differences for AEs or SAEs between the two groups were observed ( P > 0.05). ","['patients with T2D', 'type 2 diabetes (T2D', 'Type 2', 'Diabetes', '600 patients']","['Mulberry Twig Alkaloids Tablet', 'mulberry twig alkaloids (Sangzhi alkaloids [SZ-A', 'SZ-A group ( n = 360) or acarbose', 'acarbose']","['change in HbA 1c', 'Efficacy and Safety', 'adverse events (AEs), severe AEs (SAEs), treatment-related AEs (TAEs), and gastrointestinal disorders (GDs', 'change of glycosylated hemoglobin (HbA 1c ', 'incidence of TAEs and GDs', 'efficacy and safety', 'hypoglycemic effects', 'AEs or SAEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C3816748', 'cui_str': '600'}]","[{'cui': 'C0330540', 'cui_str': 'Morus'}, {'cui': 'C0002062', 'cui_str': 'Alkaloid'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0050393', 'cui_str': 'Acarbose'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0017178', 'cui_str': 'Disorder of gastrointestinal tract'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0017853', 'cui_str': 'Glycosylated hemoglobin'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C3163695', 'cui_str': 'Transarterial embolization'}, {'cui': 'C2936720', 'cui_str': 'Hypoglycemic Effects'}]",600.0,0.723153,"The incidence of TAEs and GDs was significantly lower in the SZ-A group than the acarbose group ( P < 0.01), but no differences for AEs or SAEs between the two groups were observed ( P > 0.05). ","[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Qu', 'Affiliation': 'Department of Traditional Chinese Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiaochun', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': 'Department of Traditional Chinese Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China xcliang@vip.sina.com gq_tian@126.com.'}, {'ForeName': 'Guoqing', 'Initials': 'G', 'LastName': 'Tian', 'Affiliation': 'Department of Traditional Chinese Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China xcliang@vip.sina.com gq_tian@126.com.'}, {'ForeName': 'Gaili', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Department of Traditional Chinese Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Qunli', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Department of Traditional Chinese Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiumei', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Department of Traditional Chinese Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yazhong', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Department of Traditional Chinese Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yuling', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Zhufang', 'Initials': 'Z', 'LastName': 'Shen', 'Affiliation': 'Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Changqing', 'Initials': 'C', 'LastName': 'Xiao', 'Affiliation': 'Department of Endocrinology and Metabolism, The First Affiliated Hospital, Guangxi Medical University, Guangxi, China.'}, {'ForeName': 'Yingfen', 'Initials': 'Y', 'LastName': 'Qin', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital, Guangxi Medical University, Guangxi, China.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Miao', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital, Nan Jing Medical University, Jiangsu, China.'}, {'ForeName': 'Yongyan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, Shengjing Hospital of China Medical University, Liaoning, China.'}, {'ForeName': 'Ziling', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, Inner Mongolia Baogang Hospital, Baotou, Inner Mongolia Autonomous Region, China.'}, {'ForeName': 'Shandong', 'Initials': 'S', 'LastName': 'Ye', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of University of Science and Technology of China (USTC), Division of Life Sciences and Medicine, USTC, Hefei, Anhui, China.'}, {'ForeName': 'Xuezhi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Traditional Chinese Medicine and Integrative Medicine Department, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital, Shanxi Medical University, Shanxi, China.'}, {'ForeName': 'Guiwen', 'Initials': 'G', 'LastName': 'Cao', 'Affiliation': 'Department of Endocrinology, The Forth Affiliated Hospital, Jilin University, Jilin, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Traditional Chinese Medicine, Beijing Hospital, Beijing, China.'}, {'ForeName': 'Gangyi', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital, Suzhou University, Jiangsu, China.'}, {'ForeName': 'Xiaoyue', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Endocrinology, The First People's Hospital of Yueyang, Hunan, China.""}, {'ForeName': 'Zhengfang', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital, Kunming Medical University, Yunnan, China.'}, {'ForeName': 'Yukun', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, The Third Affiliated Hospital, Hebei Medical University, Hebei, China.'}, {'ForeName': 'Xiuzhen', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, Tongji Hospital, Tongji University, Shanghai, China.'}, {'ForeName': 'Guangde', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Endocrinology, Qilu Hospital, Shandong University, Shandong, China.'}, {'ForeName': 'Wenjin', 'Initials': 'W', 'LastName': 'Hua', 'Affiliation': ""Department of Endocrinology, The Third People's Hospital of Wuxi, Jiangsu, China.""}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Department of Endocrinology, Central Hospital of Putuo District, Shanghai, China.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': 'Department of Endocrinology, West China Hospital, Sichuan University, Sichuan, China.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Bengbu Medical College, Anhui, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Liaoning, China.'}]",Diabetes care,['10.2337/dc20-2109'] 3119,33832949,"Anlotinib in Locally Advanced or Metastatic Medullary Thyroid Carcinoma: A Randomized, Double-Blind Phase IIB Trial.","PURPOSE Medullary thyroid cancer (MTC) accounts for about 2% of all thyroid cancer, but has a relatively poor prognosis compared with differentiated thyroid cancer. Anlotinib is a novel multitarget tyrosine kinase inhibitor targeting VEGFR, PDGFR, FGFR and c-Kit. This multicenter, randomized, double-blind, placebo-controlled phase ⅡB study (ALTER 01031, NCT02586350) was conducted to investigate the efficacy and safety of anlotinib in MTC. PATIENTS AND METHODS Patients with histopathologically confirmed, unresectable locally advanced or metastatic MTC were enrolled and randomly assigned in a 2:1 ratio to receive anlotinib (12mg once daily from day 1 to 14 every 3 weeks) or placebo. Patients in placebo group were allowed to receive open-label anlotinib after disease progression. The primary end point was progression-free survival (PFS); secondary end points included objective response rate (ORR), disease control rate (DCR), and overall survival (OS). RESULTS 91 patients were enrolled. At data cutoff date, the median PFS was significantly prolonged in anlotinib group than in placebo group (20.7 months vs. 11.1 months, P = 0.029, HR = 0.53 [95% CI, 0.30-0.95]). The ORR of anlotinib treatment was 48.4%. The incidence of treatment related adverse events (TRAE) was 100% and 89.7% in anlotinib and placebo groups. The most common TRAE of all grades in the anlotinib group were palmar-plantar erythrodysesthesia syndrome (62.9%), proteinuria (61.3%) and hypertriglyceridemia (48.4%). CONCLUSION Anlotinib demonstrates its efficacy and safety in this phase ⅡB trial for the treatment of MTC and may become a new choice for this rare disease, especially for Chinese patients.",2021,The incidence of treatment related adverse events (TRAE) was 100% and 89.7% in anlotinib and placebo groups.,"['Patients with histopathologically confirmed, unresectable locally advanced or metastatic MTC', 'Chinese patients', '91 patients were enrolled', 'Locally Advanced or Metastatic Medullary Thyroid Carcinoma']","['placebo', 'MTC', 'anlotinib']","['palmar-plantar erythrodysesthesia syndrome', 'median PFS', 'efficacy and safety', 'objective response rate (ORR), disease control rate (DCR), and overall survival (OS', 'hypertriglyceridemia', 'adverse events (TRAE', 'progression-free survival (PFS', 'proteinuria']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0238462', 'cui_str': 'Medullary thyroid carcinoma'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0238462', 'cui_str': 'Medullary thyroid carcinoma'}, {'cui': 'C4519250', 'cui_str': 'anlotinib'}]","[{'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}]",91.0,0.723198,The incidence of treatment related adverse events (TRAE) was 100% and 89.7% in anlotinib and placebo groups.,"[{'ForeName': 'Dapeng', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Thyroid and Neck Oncology, Tianjin Medical University Cancer Institute and Hospital.'}, {'ForeName': 'Yihebali', 'Initials': 'Y', 'LastName': 'Chi', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Beijing Tongren Hospital.'}, {'ForeName': 'Ming-Hua', 'Initials': 'MH', 'LastName': 'Ge', 'Affiliation': 'Department of Surgical Oncology, Zhejiang Province Cancer Hospital.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Jiangsu Cancer Hospital.'}, {'ForeName': 'Zhuming', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': 'Sun Yat-sen University Cancer Center.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Gansu Provincial Cancer Hospital.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Head and Neck Surgery, Central South University.'}, {'ForeName': 'Jiewu', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'First Affiliated Hospital of Zhengzhou University.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Medical Thoracic Oncology, Jilin Provincial Cancer Hospital.'}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Liaoning Cancer Hospital and Institute.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Fujian Provincial Cancer Hospital.'}, {'ForeName': 'Jianwu', 'Initials': 'J', 'LastName': 'Qin', 'Affiliation': 'Thyroid & head and Neck Surgery, Affiliated Cancer Hospital of Zhengzhou University; Henan Cancer Hospital.'}, {'ForeName': 'Jingqiang', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of Thyroid & Breast Surgery, West China Hospital of Sichuan University.'}, {'ForeName': 'Ruochuan', 'Initials': 'R', 'LastName': 'Cheng', 'Affiliation': 'Thyroid Surgery, First Affiliated Hospital of Kunming Medical University.'}, {'ForeName': 'Zhengang', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Head and Neck Surgical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College.'}, {'ForeName': 'Xiangqian', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'Tianjin Medical University Cancer Institute and Hospital.'}, {'ForeName': 'Pingzhang', 'Initials': 'P', 'LastName': 'Tang', 'Affiliation': 'National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College ,Beijing,100021,Chin.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Gao', 'Affiliation': 'Department of Thyroid and Neck Oncology, Tianjin Medical University Cancer Institute and Hospital; National Clinical Research Center for Cancer; Key Laboratory of Cancer Prevention and Therapy; Tianjin Union Medical Center gaoming68@aliyun.com.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-2950'] 3120,33832947,Plasma KIM-1 is associated with recurrence risk after nephrectomy for localized renal cell carcinoma: A trial of the ECOG-ACRIN Research Group (E2805).,"PURPOSE No circulating biomarkers are currently available to identify patients at highest risk of recurrence after nephrectomy for renal cell carcinoma (RCC). Kidney injury molecule-1 (KIM-1) is overexpressed in RCC and its ectodomain circulates in plasma. We investigated whether plasma KIM-1 is a prognostic biomarker in patients with localized RCC after nephrectomy. EXPERIMENTAL DESIGN The ECOG-ACRIN E2805 (ASSURE) trial evaluated adjuvant sunitinib, sorafenib, or placebo in resected high-risk RCC. KIM-1 levels were measured from banked plasma at trial enrollment 4-12 weeks post-nephrectomy. Lognormal accelerated failure time (AFT) models were used to test for association between KIM-1 and disease-free survival (DFS) as well as overall survival (OS). RESULTS Plasma from 418 patients was analyzed. Higher post-nephrectomy KIM-1 was associated with worse DFS across all study arms after adjustment for Fuhrman grade, T-stage, N-stage, and tumor histology (survival time ratio 0.56 for 75 th vs 25 th percentile of KIM-1, 95% CI 0.42-0.73, p < 0.001). The association between KIM-1 and DFS was stronger among patients with pathologic nodal involvement (p-value for interaction 0.0086). The addition of post-nephrectomy KIM-1 improved the concordance of clinical prognostic models (SSIGN concordance 0.57 vs 0.43, p = 0.05; UISS concordance 0.60 vs 0.40, p = 0.0005). Higher post-nephrectomy KIM-1 was also associated with worse overall survival (OS) after multivariable adjustment (survival time ratio 0.71 for 75 th vs 25 th percentile of KIM-1, 95% CI 0.56-0.91, p < 0.001). CONCLUSIONS Post-nephrectomy plasma KIM-1 is associated with DFS and OS in RCC, and may be a biomarker for microscopic residual disease.",2021,"Higher post-nephrectomy KIM-1 was associated with worse DFS across all study arms after adjustment for Fuhrman grade, T-stage, N-stage, and tumor histology (survival time ratio 0.56 for 75 th vs 25 th percentile of KIM-1, 95% CI 0.42-0.73, p < 0.001).","['418 patients was analyzed', 'patients at highest risk of recurrence after nephrectomy for renal cell carcinoma (RCC', 'patients with localized RCC after nephrectomy', 'localized renal cell carcinoma']","['adjuvant sunitinib, sorafenib, or placebo']","['Kidney injury molecule-1 (KIM-1', 'KIM-1 and disease-free survival (DFS', 'KIM-1 and DFS', 'KIM-1 levels', 'Lognormal accelerated failure time (AFT) models', 'tumor histology (survival time ratio', 'overall survival (OS', 'concordance of clinical prognostic models']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0027695', 'cui_str': 'Kidney excision'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1313407', 'cui_str': 'HAVCR1 protein, human'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",418.0,0.251945,"Higher post-nephrectomy KIM-1 was associated with worse DFS across all study arms after adjustment for Fuhrman grade, T-stage, N-stage, and tumor histology (survival time ratio 0.56 for 75 th vs 25 th percentile of KIM-1, 95% CI 0.42-0.73, p < 0.001).","[{'ForeName': 'Wenxin', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Medical Oncology, Dana-Farber Cancer Institute.'}, {'ForeName': 'Maneka', 'Initials': 'M', 'LastName': 'Puligandla', 'Affiliation': 'Department of Biostatistical Sciences, Dana-Farber Cancer Institute.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Halbert', 'Affiliation': 'Division of Hematology-Oncology, Beth Israel Deaconess Medical Center.'}, {'ForeName': 'Naomi B', 'Initials': 'NB', 'LastName': 'Haas', 'Affiliation': 'Medical Oncology, Raymond and Ruth Perelman School of Medicine at the University of Pennsylvania.'}, {'ForeName': 'Keith T', 'Initials': 'KT', 'LastName': 'Flaherty', 'Affiliation': 'Developmental Therapeutics, Massachusetts General Hospital Cancer Center.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Uzzo', 'Affiliation': 'Division of Urologic Oncology, Department of Surgical Oncology, Fox Chase Cancer Center.'}, {'ForeName': 'Janice P', 'Initials': 'JP', 'LastName': 'Dutcher', 'Affiliation': 'Hematology/Oncology, Cancer Research Foundation of New York, Inc.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'DiPaola', 'Affiliation': 'Medical Oncology, University of Kentucky College of Medicine.'}, {'ForeName': 'Venkata', 'Initials': 'V', 'LastName': 'Sabbisetti', 'Affiliation': ""Medicine, Brigham and Women's Hospital.""}, {'ForeName': 'Rupal S', 'Initials': 'RS', 'LastName': 'Bhatt', 'Affiliation': 'Division of Hematology-Oncology, Beth Israel Deaconess Medical Center rbhatt@bidmc.harvard.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-21-0025'] 3121,33832885,An alternative approach to treat obesity with leptogenic polyherbal formulation obesecure: A randomized clinical trial study.,"Obesity is a common disease of developing countries, including Pakistan. Obesity is a risk factor for many diseases which can be life threatening or making the person unable to perform daily routine work. In the current study, clinical trials were designed to evaluate the effects of medical intervention by comparing the effects of placebo control drug ""Plasicure"" with the herbal medicinal formulation ""Obesecure"". The test drug formulation was designed on the basis of the screening study for Leptogenic drugs. To evaluate the safety of the test drug, the toxicity index and the safety profile of test formulation was assessed on animal models. The drug was found safe for further clinical study. Randomized Controlled Clinical Trials were conducted. The statistical analysis was carried out by the application of Two-Way Repeated Analysis of Variance test. The clinical findings of randomized controlled trial revealed that the test drug was Leptogenic and effective in weight reduction as compared to control drug Plasicure therapy as the p-value deduced was 0.001 in leptin level and 0.000 in case of BMI after the conduction of Two-Way Repeated Analysis of Variance test. Hence it is concluded that obscure therapy is more significant than control drug Plasicure therapy in the management and treatment of obesity.",2020,Obesity is a risk factor for many diseases which can be life threatening or making the person unable to perform daily routine work.,[],['placebo'],"['toxicity index', 'Leptogenic and effective in weight reduction']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.19407,Obesity is a risk factor for many diseases which can be life threatening or making the person unable to perform daily routine work.,"[{'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Riazurrehman', 'Affiliation': 'Faculty of Eastern medicine, Hamdard University, Karachi, Pakistan.'}, {'ForeName': 'Asif', 'Initials': 'A', 'LastName': 'Iqbal', 'Affiliation': 'Faculty of Eastern medicine, Hamdard University, Karachi, Pakistan.'}, {'ForeName': 'Sultan', 'Initials': 'S', 'LastName': 'Ayaz', 'Affiliation': 'Directorate of Medical Sciences, GC University, Faisalabad, Pakistan.'}, {'ForeName': 'Haris', 'Initials': 'H', 'LastName': 'Khurram', 'Affiliation': 'Department of Sciences and Humanities, National University of Computer and Emerging Sciences, Faisalabad, Pakistan.'}, {'ForeName': 'Naheed', 'Initials': 'N', 'LastName': 'Akhter', 'Affiliation': 'Directorate of Medical Sciences, GC University, Faisalabad, Pakistan.'}, {'ForeName': 'Arshad', 'Initials': 'A', 'LastName': 'Mahmood', 'Affiliation': 'Faculty of Science, Barret Hodgson University, Karachi, Pakistan.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Akram', 'Affiliation': 'Directorate of Medical Sciences, GC University, Faisalabad, Pakistan.'}, {'ForeName': 'Abid', 'Initials': 'A', 'LastName': 'Rashid', 'Affiliation': 'Directorate of Medical Sciences, GC University, Faisalabad, Pakistan.'}, {'ForeName': 'Hafiz Muhammad', 'Initials': 'HM', 'LastName': 'Asif', 'Affiliation': 'College of Conventional Medicine, The Islamia University of Bahawalpur, Bahawalpur, Pakistan.'}]",Pakistan journal of pharmaceutical sciences,[] 3122,33832882,Therapeutic effect of piracetam with nimodipine on vascular dementia after cerebral infarction.,"This article investigated the clinical effects of piracetam with nimodipine in the treatment of vascular dementia (VD) after cerebral infarction. 98 patients with vascular dementia after cerebral infarction were selected and divided into the control group and the study group according to the treatment method. The control group was treated with nimodipine alone. The study group was treated with piracetam on the basis of this observation, and we test the ADL (life ability score), MoCA(montreal cognitive assessment scale), ADAS-Cog(alzheimer's scale-cognition), MMSE(mental status examination) scores and quality of life scores before and after treatment in the two groups. Before treatment, there were no significant differences in ADL, MoCA, and ADAS-Cog scores between the two groups (P>0.05). After treatment, the ADL, MoCA, and ADAS-Cog scores of the study group were superior to the control group. The difference was statistically significant (P<0.05). There was no significant difference in MMSE scores between the two groups before treatment and 1 month after treatment (P>0.05). The MMSE scores of the study group were better than the control group after 3 months of treatment and half a year after treatment. The difference was statistically significant (P <0.05). Before treatment, there was no significant difference in the quality of life scores between the two groups (P>0.05). After treatment, the quality of life scores was significantly higher than the control group, and the difference was statistically significant (P<0.05). For patients with vascular dementia after cerebral infarction, piracetam combined with nimodipine can improve the cognitive function, improve the quality of life, and have a significant clinical effect.",2020,"Before treatment, there were no significant differences in ADL, MoCA, and ADAS-Cog scores between the two groups (P>0.05).","['98 patients with vascular dementia after cerebral infarction', 'vascular dementia after cerebral infarction', 'patients with vascular dementia after cerebral infarction', 'vascular dementia (VD) after cerebral infarction']","['piracetam combined with nimodipine', 'nimodipine alone', 'piracetam', 'piracetam with nimodipine']","['MMSE scores', 'quality of life', ""ADL (life ability score), MoCA(montreal cognitive assessment scale), ADAS-Cog(alzheimer's scale-cognition), MMSE(mental status examination) scores and quality of life scores"", 'quality of life scores', 'ADL, MoCA, and ADAS-Cog scores', 'cognitive function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011269', 'cui_str': 'Vascular dementia'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}]","[{'cui': 'C0031977', 'cui_str': 'Piracetam'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0028094', 'cui_str': 'Nimodipine'}]","[{'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0001457', 'cui_str': 'Adenosine deaminase'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0420607', 'cui_str': 'Examination categorized by action status'}, {'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C0009738', 'cui_str': 'Congo'}]",98.0,0.0231692,"Before treatment, there were no significant differences in ADL, MoCA, and ADAS-Cog scores between the two groups (P>0.05).","[{'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Zongfang', 'Affiliation': ""Outpatient Department, Tengzhou Central People's Hospital, Tengzhou, China.""}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Wenjing', 'Affiliation': ""Internal Medicine-Neurology, Tengzhou Central People's Hospital, Tengzhou, China.""}, {'ForeName': 'Chai', 'Initials': 'C', 'LastName': 'Zhaomin', 'Affiliation': ""Gastrointestinal Surgery Department, Tengzhou Central People's Hospital, Tengzhou, China.""}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Lei', 'Affiliation': ""Rehabilitation Department, Tengzhou Central People's Hospital, Tengzhou, China.""}]",Pakistan journal of pharmaceutical sciences,[] 3123,33823163,The initial visual performance modulates the effects of anodal transcranial direct current stimulation over the primary visual cortex on the contrast sensitivity function.,"Transcranial direct current stimulation (tDCS) has great potential to modulate cortical excitability and further facilitate visual function or rehabilitation. However, tDCS modulation effects are largely variable, possibly because of the individual differences in initial performance. The present study investigated the influence of the initial performance on contrast sensitivity function (CSF) following tDCS. Fifty healthy participants were randomly assigned to three groups: anodal, cathodal and sham stimulation. The CSF was measured through a grating detection task before and immediately after tDCS. Active and reference electrodes were applied to the primary occipital cortex (Oz) and the middle of the head (Cz) for 20 min with an intensity of 1.5 mA, respectively. Compared with sham stimulation, anodal or cathodal stimulation had no effect on the area under the log CSF (AULCSF) or contrast sensitivity (CS) of various spatial frequencies at the group level. However, a negative relationship was found between initial performance and the AULCSF change (or CS change at a spatial of frequency 8 c/°) after the application of anodal tDCS, indicating that the degree of change was dependent on initial performance, with greater gains observed for those with poorer initial performance. Initial performance modulated the effect of anodal tDCS over the Oz on the CSF, indicating that the Oz plays a crucial role in visual function. These results contribute to a deep understanding of the mechanisms of tDCS and to the design of more precise and efficient personalized simulation approaches based on individual differences.",2021,"Compared with sham stimulation, anodal or cathodal stimulation had no effect on the area under the log CSF (AULCSF) or contrast sensitivity (CS) of various spatial frequencies at the group level.",['Fifty healthy participants'],"['Transcranial direct current stimulation (tDCS', 'anodal tDCS', 'anodal transcranial direct current stimulation', 'anodal, cathodal and sham stimulation']","['contrast sensitivity function (CSF', 'area under the log CSF (AULCSF) or contrast sensitivity (CS) of various spatial frequencies', 'initial performance and the AULCSF change (or CS change']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",50.0,0.027906,"Compared with sham stimulation, anodal or cathodal stimulation had no effect on the area under the log CSF (AULCSF) or contrast sensitivity (CS) of various spatial frequencies at the group level.","[{'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': ""Department of Medical Psychology, Air Force Medical University, Xi'an, China.""}, {'ForeName': 'YingJie', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ""Basic Medical School, Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Haixu', 'Initials': 'H', 'LastName': 'Lv', 'Affiliation': ""Basic Medical School, Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Liu', 'Affiliation': ""Department of Nursing, Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Pan', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychology, Hebei Normal University, Shijiazhuang, China. Electronic address: zhang2005pan@126.com.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2021.107854'] 3124,33826106,Pharmacokinetic and Pharmacodynamic Evaluation of Ravulizumab in Adults with Severe Coronavirus Disease 2019.,"INTRODUCTION Terminal complement amplification is hypothesized to be a key contributor to the clinical manifestations of severe coronavirus disease 2019 (COVID-19). Ravulizumab, a humanized monoclonal antibody that binds with high affinity to complement protein C5 and inhibits terminal complement activation, is being evaluated as a treatment for COVID-19-related severe pneumonia, acute lung injury, and acute respiratory distress syndrome in an ongoing phase 3 randomized controlled trial (ALXN1210-COV-305). To address the overactivation of terminal complement in severe COVID-19 compared to the diseases in which ravulizumab is currently approved, a modified dosing regimen was adopted. This analysis evaluates preliminary pharmacokinetic/pharmacodynamic data to confirm the modified dosing regimen. METHODS Weight-based ravulizumab doses were administered on days 1, 5, 10, and 15. Serum levels of ravulizumab and free C5 were measured before and after administration of ravulizumab and any time on day 22. Free C5 levels < 0.5 μg/mL indicate complete C5 inhibition. The pharmacokinetic target was defined as ravulizumab concentrations at the end of the dosing interval > 175 μg/mL, the concentration above which C5 is completely inhibited. RESULTS Twenty-two patients were included in this evaluation. At baseline, mean C5 concentration was 240 ± 67 μg/mL. In all patients and at all individual timepoints after the first dose was administered, ravulizumab concentrations remained > 175 μg/mL and free C5 concentrations remained < 0.5 μg/mL. CONCLUSION High levels of baseline C5 observed in patients with severe COVID-19 contribute to the growing body of evidence that suggests this disease is marked by amplification of terminal complement activation. Data from this preliminary pharmacokinetic/pharmacodynamic evaluation of 22 patients with severe COVID-19 show that the modified ravulizumab dosing regimen achieved immediate and complete terminal complement inhibition, which can be sustained for up to 22 days. These data support the continued use of this dosage regimen in the ongoing phase 3 study. TRIAL REGISTRATION ClinicalTrials.gov identifier, NCT04369469.",2021,Serum levels of ravulizumab and free C5 were measured before and after administration of ravulizumab and any time on day 22.,"['175\xa0μg', 'Adults with Severe Coronavirus Disease 2019', 'Twenty-two patients were included in this evaluation', '22 patients with severe COVID-19']","['Ravulizumab', 'ravulizumab']","['Free C5 levels', 'ravulizumab concentrations', 'Serum levels of ravulizumab and free C5', 'mean C5 concentration', 'free C5 concentrations']","[{'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]","[{'cui': 'C4550350', 'cui_str': 'ravulizumab'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0446415', 'cui_str': 'Level of the fifth cervical vertebra'}, {'cui': 'C4550350', 'cui_str': 'ravulizumab'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",22.0,0.117232,Serum levels of ravulizumab and free C5 were measured before and after administration of ravulizumab and any time on day 22.,"[{'ForeName': 'Alanna C', 'Initials': 'AC', 'LastName': 'McEneny-King', 'Affiliation': 'Clinical Development and Translational Sciences, Clinical Pharmacology, Alexion Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Jonathan P R', 'Initials': 'JPR', 'LastName': 'Monteleone', 'Affiliation': 'Clinical Development and Translational Sciences, Pharmacometrics, Alexion Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Shamsah D', 'Initials': 'SD', 'LastName': 'Kazani', 'Affiliation': 'Clinical Development and Translational Sciences, Alexion Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Stephan R', 'Initials': 'SR', 'LastName': 'Ortiz', 'Affiliation': 'Clinical Development and Translational Sciences, Clinical Pharmacology, Alexion Pharmaceuticals, Boston, MA, USA. Stephan.Ortiz@alexion.com.'}]",Infectious diseases and therapy,['10.1007/s40121-021-00425-7'] 3125,33829720,"Comparative Evaluation of the Effectiveness of 40% Miswak Mouthwash and 0.12% Chlorhexidine Mouthwash in Treating Gingivitis: A Blinded, Randomised Clinical Trial.","PURPOSE To assess the effectiveness of a 40% miswak compared to a 0.12% chlorhexidine mouthwash. MATERIALS AND METHODS A total of 60 patients aged 20-55 years who attended the Periodontics Clinics at the College of Dentistry, Al-Iraqia University, Baghdad, Iraq, were allocated into 2 groups to use either 40% miswak mouthwash or 0.12% chlorhexidine gluconate Kin Gingival (Laboratorios KIN) twice daily for 2 months. Gingival, bleeding, and plaque indices were assessed. RESULTS There were statistically significant differences between the effectiveness of miswak and chlorhexidine mouthwashes in terms of gingivitis. The means of gingival, bleeding, and plaque indices using miswak mouthwash were 1.2, 0.4, and 0.53, respectively, i.e. indicating lower effectiveness, than when 0.12% chlorhexidine mouthwash was used (0.87, 0.43, 0.23, respectively). CONCLUSION Miswak mouthwash is a good oral hygiene agent especially for long-term use even if its efficacy is lower than chlorhexidine mouthwash.",2021,There were statistically significant differences between the effectiveness of miswak and chlorhexidine mouthwashes in terms of gingivitis.,"['60 patients aged 20-55 years who attended the Periodontics Clinics at the College of Dentistry, Al-Iraqia University, Baghdad, Iraq', 'Treating Gingivitis']","['chlorhexidine', '40% miswak mouthwash or 0.12% chlorhexidine gluconate Kin Gingival (Laboratorios KIN', '40% Miswak Mouthwash and 0.12% Chlorhexidine Mouthwash']","['gingivitis', 'means of gingival, bleeding, and plaque indices using miswak mouthwash', 'Gingival, bleeding, and plaque indices']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0031098', 'cui_str': 'Periodontics'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0011438', 'cui_str': 'Dentistry'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022066', 'cui_str': 'Iraq'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C4517426', 'cui_str': '0.12'}, {'cui': 'C0055361', 'cui_str': 'Chlorhexidine gluconate'}, {'cui': 'C0682416', 'cui_str': 'Ruanda language'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0352155', 'cui_str': 'Chlorhexidine Mouthwash'}]","[{'cui': 'C0008684', 'cui_str': 'Chronic gingivitis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}]",60.0,0.0390118,There were statistically significant differences between the effectiveness of miswak and chlorhexidine mouthwashes in terms of gingivitis.,"[{'ForeName': 'Sumayah', 'Initials': 'S', 'LastName': 'Al-Mahmood', 'Affiliation': ''}, {'ForeName': 'Dunia Wadeea', 'Initials': 'DW', 'LastName': 'Sabea', 'Affiliation': ''}]",Oral health & preventive dentistry,['10.3290/j.ohpd.b1179501'] 3126,33829710,[A Randomized Controlled Study of Intravesical Instillation Therapy of Bacillus Calmette-Guérin vs. Epirubicinin Treating Non-muscular Invasive Bladder Cancer].,"Objective To explore the best treatment plan of intravesical instillation for patients with non-muscular invasive bladder cancer (NMIBC), to explore recurrence-related clinicopathological factors after intravesical instillation, and to evaluate the value of the prognosis and prediction models currently used for NMIBC patients. Methods Starting from 2016, patients who underwent transurethral resection of bladder tumor (TURBT) in our hospital and who received post-surgery diagnosis of having intermediate or high risks for NMIBC were enrolled in the study. They were randomly assigned to different group sat a ratio of 2∶2∶1 for receiving intravesical instillation therapy of Bacillus Calmette-Guérin (BCG) for 19 times, BCG for 15 times, and epirubicin (EPI) for 18 times. The clinicopathological data of the patients were recorded before, during and after instillation therapy, and survival curves were drawn to evaluate the effects of the three regimens, using recurrence-free survival as the endpoint. Clinicopathological data were analyzed to study the associations between various factors and post-instillation recurrence. The consistency index (c-index) was used to evaluate the predictive accuracy of the scoring model of the Spanish Urological Club for Oncological Treatment (CUETO) and the risk tables of European Organization for Research and Treatment of Cancer (EORTC). Results A total of 93 NMIBC patients (35 in the 19-time BCG group, 37 in the 15-time BCG group, and 21 in the EPI group) were included, with a median follow-up time of 33.46 months. Twenty-two patients experienced tumor recurrence and eight, tumor progression. The survival curve showed that the BCG group had better recurrence-free survival than the EPI group ( P =0.002), while the difference in recurrence-free survival between 19-time BCG and 15-time BCG groups was not statistically significant. Higher general complication rate was seen in the BCG groups compared with the EPI group (84.7% vs. 61.9%, P =0.022), but there was no grade 3-5 adverse events in any group. The c-index of CUETO scoring model and EORTC risk tables was higher than that of the prediction based solely on T stage, nuclear grade, or EAU risk stratification. In addition, the c-index in the BCG group was higher than that in the whole cohort. Conclusion Among the subjects of this study, the recurrence rate of bladder cancer in the intravesical BCG instillation groups was lower than that of the epirubicin group. EORTC risk tables and CUETO scoring model exhibited higher predictive accuracies in BCG-treated patients than its performance for the whole NMIBC cohort.",2021,EORTC risk tables and CUETO scoring model exhibited higher predictive accuracies in BCG-treated patients than its performance for the whole NMIBC cohort.,"['patients with non-muscular invasive bladder cancer (NMIBC', 'Non-muscular Invasive Bladder Cancer', 'in our hospital and who received post-surgery diagnosis of having intermediate or high risks for NMIBC were enrolled in the study', '93 NMIBC patients (35 in the 19-time BCG group, 37 in the 15-time BCG group, and 21 in the EPI group']","['epirubicin (EPI', 'BCG', 'epirubicin', 'intravesical instillation', 'transurethral resection of bladder tumor (TURBT', 'intravesical instillation therapy of Bacillus Calmette-Guérin (BCG', 'Bacillus Calmette-Guérin vs. Epirubicinin Treating', 'Intravesical Instillation Therapy']","['recurrence-free survival', 'survival curve', 'tumor recurrence and eight, tumor progression', 'survival curves', 'recurrence rate of bladder cancer', 'general complication rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}]","[{'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0021917', 'cui_str': 'Instillation of bladder'}, {'cui': 'C0401496', 'cui_str': 'Transurethral resection of bladder neoplasm'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0521158', 'cui_str': 'Recurrent tumor'}, {'cui': 'C0178874', 'cui_str': 'Tumor progression'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",93.0,0.0454859,EORTC risk tables and CUETO scoring model exhibited higher predictive accuracies in BCG-treated patients than its performance for the whole NMIBC cohort.,"[{'ForeName': 'Wei-Xiao', 'Initials': 'WX', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, Institute of Urology, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Yan-Xiang', 'Initials': 'YX', 'LastName': 'Shao', 'Affiliation': 'Department of Urology, Institute of Urology, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Urology, Institute of Urology, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'San-Chao', 'Initials': 'SC', 'LastName': 'Xiong', 'Affiliation': 'Department of Urology, Institute of Urology, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, Institute of Urology, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Institute of Urology, West China Hospital, Sichuan University, Chengdu 610041, China.'}]",Sichuan da xue xue bao. Yi xue ban = Journal of Sichuan University. Medical science edition,['10.12182/20210360203'] 3127,33829034,Can a Higher Protein/Low Glycemic Index vs. a Conventional Diet Attenuate Changes in Appetite and Gut Hormones Following Weight Loss? A 3-Year PREVIEW Sub-study.,"Background: Previous research showed that weight-reducing diets increase appetite sensations and/or circulating ghrelin concentrations for up to 36 months, with transient or enduring perturbations in circulating concentrations of the satiety hormone peptide YY. Objective: This study assessed whether a diet that is higher in protein and low in glycemic index (GI) may attenuate these changes. Methods: 136 adults with pre-diabetes and a body mass index of ≥25 kg/m 2 underwent a 2-month weight-reducing total meal replacement diet. Participants who lost ≥8% body weight were randomized to one of two 34-month weight-maintenance diets: a higher-protein and moderate-carbohydrate (CHO) diet with low GI, or a moderate-protein and higher-CHO diet with moderate GI. Both arms involved recommendations to increase physical activity. Fasting plasma concentrations of total ghrelin and total peptide YY, and appetite sensations, were measured at 0 months (pre-weight loss), at 2 months (immediately post-weight loss), and at 6, 12, 24, and 36 months. Results: There was a decrease in plasma peptide YY concentrations and an increase in ghrelin after the 2-month weight-reducing diet, and these values approached pre-weight-loss values by 6 and 24 months, respectively ( P = 0.32 and P = 0.08, respectively, vs. 0 months). However, there were no differences between the two weight-maintenance diets. Subjective appetite sensations were not affected by the weight-reducing diet nor the weight-maintenance diets. While participants regained an average of ~50% of the weight they had lost by 36 months, the changes in ghrelin and peptide YY during the weight-reducing phase did not correlate with weight regain. Conclusion: A higher-protein, low-GI diet for weight maintenance does not attenuate changes in ghrelin or peptide YY compared with a moderate-protein, moderate-GI diet. Clinical Trial Registry: ClinicalTrials.gov registry ID NCT01777893 (PREVIEW) and ID NCT02030249 (Sub-study).",2021,"There was a decrease in plasma peptide YY concentrations and an increase in ghrelin after the 2-month weight-reducing diet, and these values approached pre-weight-loss values by 6 and 24 months, respectively ( P = 0.32 and P = 0.08, respectively, vs. 0 months).","['Participants who lost ≥8% body weight', '136 adults with pre-diabetes and a body mass index of ≥25 kg']","['weight-maintenance diets: a higher-protein and moderate-carbohydrate (CHO) diet with low GI, or a moderate-protein and higher-CHO diet with moderate GI', '2-month weight-reducing total meal replacement diet']","['weight regain', 'plasma peptide YY concentrations', 'Fasting plasma concentrations of total ghrelin and total peptide YY, and appetite sensations', 'physical activity', 'Subjective appetite sensations']","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0311129', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0301577', 'cui_str': 'Carbohydrate diet'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",136.0,0.101417,"There was a decrease in plasma peptide YY concentrations and an increase in ghrelin after the 2-month weight-reducing diet, and these values approached pre-weight-loss values by 6 and 24 months, respectively ( P = 0.32 and P = 0.08, respectively, vs. 0 months).","[{'ForeName': 'Marion E C', 'Initials': 'MEC', 'LastName': 'Buso', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, Wageningen, Netherlands.'}, {'ForeName': 'Radhika V', 'Initials': 'RV', 'LastName': 'Seimon', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise, and Eating Disorders, Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'McClintock', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise, and Eating Disorders, Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Roslyn', 'Initials': 'R', 'LastName': 'Muirhead', 'Affiliation': 'School of Life and Environmental Sciences and Charles Perkins Centre, The University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Fiona S', 'Initials': 'FS', 'LastName': 'Atkinson', 'Affiliation': 'School of Life and Environmental Sciences and Charles Perkins Centre, The University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Brodie', 'Affiliation': 'School of Life and Environmental Sciences and Charles Perkins Centre, The University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Jarron', 'Initials': 'J', 'LastName': 'Dodds', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise, and Eating Disorders, Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Zibellini', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise, and Eating Disorders, Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Arpita', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'School of Life and Environmental Sciences and Charles Perkins Centre, The University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Anthony L', 'Initials': 'AL', 'LastName': 'Wild-Taylor', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise, and Eating Disorders, Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Burk', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise, and Eating Disorders, Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Fogelholm', 'Affiliation': 'Department of Food and Environmental Sciences, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Raben', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jennie C', 'Initials': 'JC', 'LastName': 'Brand-Miller', 'Affiliation': 'School of Life and Environmental Sciences and Charles Perkins Centre, The University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Sainsbury', 'Affiliation': 'School of Human Sciences, Faculty of Science, The University of Western Australia, Crawley, WA, Australia.'}]",Frontiers in nutrition,['10.3389/fnut.2021.640538'] 3128,33829030,An Enhanced High-Volume Preparation for Colonoscopy Is Not Better Than a Conventional Low-Volume One in Patients at Risk of Poor Bowel Cleansing: A Randomized Controlled Trial.,"Objective: We tested the hypothesis that an enhanced bowel preparation strategy (EBS) improves colonic cleansing in patients at high risk for inadequate bowel cleansing (HRI). Methods: This prospective randomized clinical trial included consecutive HRI patients referred for outpatient colonoscopy between February and October 2019. HRI was considered if patients scored >1.225 according to a previously validated bowel-cleansing predictive score. HRI patients were randomized (1:1) to a low-volume conventional bowel cleansing strategy (CBS) (1-day low residue diet (LRD) plus 2 L of polyethylene glycol (PEG) plus ascorbic acid) or to an EBS (3-day LRD plus 10 mg oral bisacodyl plus 4 L PEG). The Boston Bowel Preparation Scale (BBPS) was used to assess the quality of cleanliness. Intention-to-treat (ITT) and per protocol (PP) analyses were performed. A sample size of 130 patients per group was estimated to reach a 15% difference in favor of EBP. Results: A total of 253 HRI patients were included (mean age 69.8 ± 9.5 years, 51.8% women). No statistically significant differences were found in the BBPS scale between the two groups in the ITT analysis (CBS 76.8% vs. EBS 79.7%, P = 0.58) or PP analysis (CBS 78% vs. EBS 84.3%, P = 0.21), risk difference 2.9% (95% CI-7.26 to 39.16) in the ITT analysis, or risk difference 6.3% (95% CI-3.48 to 16.08) in PP analysis. No differences in preparation tolerance, compliance, adverse effects, or colonoscopy findings were found. Conclusion: EBS is not superior to CBS in hard-to-prepare patients. (EUDRACT: 2017-000787-15, NCT03830489). Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT03830489.",2021,"No statistically significant differences were found in the BBPS scale between the two groups in the ITT analysis (CBS 76.8% vs. EBS 79.7%, P = 0.58) or PP analysis (CBS 78% vs. EBS 84.3%, P = 0.21), risk difference 2.9% (95% CI-7.26 to 39.16) in the ITT analysis, or risk difference 6.3% (95% CI-3.48 to 16.08) in PP analysis.","['HRI patients', 'patients at high risk for inadequate bowel cleansing (HRI', 'consecutive HRI patients referred for outpatient colonoscopy between February and October 2019', '253 HRI patients were included (mean age 69.8 ± 9.5 years, 51.8% women']","['EBS', 'EBS (3-day LRD plus 10 mg oral bisacodyl plus 4 L PEG', 'Intention-to-treat (ITT', 'enhanced bowel preparation strategy (EBS', 'low-volume conventional bowel cleansing strategy (CBS) (1-day low residue diet (LRD) plus 2 L of polyethylene glycol (PEG) plus ascorbic acid']","['HRI', 'Boston Bowel Preparation Scale (BBPS', 'BBPS scale', 'preparation tolerance, compliance, adverse effects, or colonoscopy findings']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005632', 'cui_str': 'Bisacodyl'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0425404', 'cui_str': 'Low residue diet'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}]","[{'cui': 'C4302285', 'cui_str': 'BBPS - Boston bowel preparation scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}]",253.0,0.150368,"No statistically significant differences were found in the BBPS scale between the two groups in the ITT analysis (CBS 76.8% vs. EBS 79.7%, P = 0.58) or PP analysis (CBS 78% vs. EBS 84.3%, P = 0.21), risk difference 2.9% (95% CI-7.26 to 39.16) in the ITT analysis, or risk difference 6.3% (95% CI-3.48 to 16.08) in PP analysis.","[{'ForeName': 'Antonio Z', 'Initials': 'AZ', 'LastName': 'Gimeno-García', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, Spain.'}, {'ForeName': 'Goretti', 'Initials': 'G', 'LastName': 'Hernández', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, Spain.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Baute Dorta', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Reygosa', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'de la Barreda', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Hernandez-Bustabad', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, Spain.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Amaral', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, Spain.'}, {'ForeName': 'Yaiza', 'Initials': 'Y', 'LastName': 'Cedrés', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Del Castillo', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Nicolás-Pérez', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Jiménez', 'Affiliation': 'Unidad de Investigación. Hospital Universitario de Canarias, La Laguna, Spain.'}, {'ForeName': 'Onofre', 'Initials': 'O', 'LastName': 'Alarcon-Fernández', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Hernandez-Guerra', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Romero', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, Spain.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Alonso', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, Spain.'}, {'ForeName': 'Yanira', 'Initials': 'Y', 'LastName': 'González', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, Spain.'}, {'ForeName': 'Zaida', 'Initials': 'Z', 'LastName': 'Adrian', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, Spain.'}, {'ForeName': 'Domingo', 'Initials': 'D', 'LastName': 'Hernandez', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ramos', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Carrillo', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, Spain.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Felipe', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, Spain.'}, {'ForeName': 'Anjara', 'Initials': 'A', 'LastName': 'Hernández', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, Spain.'}, {'ForeName': 'Consuelo', 'Initials': 'C', 'LastName': 'Rodríguez-Jiménez', 'Affiliation': 'UICEC del Complejo Hospitalario Universitario de Canarias, Plataforma SCReN; Servicio de Farmacología Clínica, La Laguna, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Quintero', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, Spain.'}]",Frontiers in medicine,['10.3389/fmed.2021.654847'] 3129,33829023,Reduced Endothelial Function in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome-Results From Open-Label Cyclophosphamide Intervention Study.,"Introduction: Patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) present with a range of symptoms including post-exertional malaise (PEM), orthostatic intolerance, and autonomic dysfunction. Dysfunction of the blood vessel endothelium could be an underlying biological mechanism, resulting in inability to fine-tune regulation of blood flow according to the metabolic demands of tissues. The objectives of the present study were to investigate endothelial function in ME/CFS patients compared to healthy individuals, and assess possible changes in endothelial function after intervention with IV cyclophosphamide. Methods: This substudy to the open-label phase II trial ""Cyclophosphamide in ME/CFS"" included 40 patients with mild-moderate to severe ME/CFS according to Canadian consensus criteria, aged 18-65 years. Endothelial function was measured by Flow-mediated dilation (FMD) and Post-occlusive reactive hyperemia (PORH) at baseline and repeated after 12 months. Endothelial function at baseline was compared with two cohorts of healthy controls ( N = 66 and N = 30) from previous studies. Changes in endothelial function after 12 months were assessed and correlated with clinical response to cyclophosphamide. Biological markers for endothelial function were measured in serum at baseline and compared with healthy controls ( N = 30). Results: Baseline FMD was significantly reduced in patients (median FMD 5.9%, range 0.5-13.1, n = 35) compared to healthy individuals (median FMD 7.7%, range 0.7-21, n = 66) ( p = 0.005), as was PORH with patient score median 1,331 p.u. (range 343-4,334) vs. healthy individuals 1,886 p.u. (range 808-8,158) ( p = 0.003). No significant associations were found between clinical response to cyclophosphamide intervention (reported in 55% of patients) and changes in FMD/PORH from baseline to 12 months. Serum levels of metabolites associated with endothelial dysfunction showed no significant differences between ME/CFS patients and healthy controls. Conclusions: Patients with ME/CFS had reduced endothelial function affecting both large and small vessels compared to healthy controls. Changes in endothelial function did not follow clinical responses during follow-up after cyclophosphamide IV intervention.",2021,No significant associations were found between clinical response to cyclophosphamide intervention (reported in 55% of patients) and changes in FMD/PORH from baseline to 12 months.,"['range 343-4,334) vs. healthy individuals 1,886 p.u', '40 patients with mild-moderate to severe ME/CFS according to Canadian consensus criteria, aged 18-65 years', 'Myalgic Encephalomyelitis/Chronic Fatigue Syndrome', 'Patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) present with a range of symptoms including post-exertional malaise (PEM), orthostatic intolerance, and autonomic dysfunction']","['Cyclophosphamide', 'cyclophosphamide']","['Flow-mediated dilation (FMD) and Post-occlusive reactive hyperemia (PORH', 'Biological markers for endothelial function', 'Endothelial Function', 'FMD/PORH', 'Endothelial function', 'endothelial function', 'Serum levels of metabolites associated with endothelial dysfunction', 'Baseline FMD']","[{'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2732413', 'cui_str': 'Postexertional fatigue'}, {'cui': 'C1535893', 'cui_str': 'Orthostatic intolerance'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0013363', 'cui_str': 'Dysautonomia'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",40.0,0.0304748,No significant associations were found between clinical response to cyclophosphamide intervention (reported in 55% of patients) and changes in FMD/PORH from baseline to 12 months.,"[{'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Sørland', 'Affiliation': 'Department of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Miriam Kristine', 'Initials': 'MK', 'LastName': 'Sandvik', 'Affiliation': 'Porsgrunn District Psychiatric Centre, Telemark Hospital Trust, Porsgrunn, Norway.'}, {'ForeName': 'Ingrid Gurvin', 'Initials': 'IG', 'LastName': 'Rekeland', 'Affiliation': 'Department of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Lis', 'Initials': 'L', 'LastName': 'Ribu', 'Affiliation': 'Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Milada Cvancarova', 'Initials': 'MC', 'LastName': 'Småstuen', 'Affiliation': 'Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Mella', 'Affiliation': 'Department of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Øystein', 'Initials': 'Ø', 'LastName': 'Fluge', 'Affiliation': 'Department of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway.'}]",Frontiers in medicine,['10.3389/fmed.2021.642710'] 3130,33827700,The efficacy of calcitriol treatment in non-alcoholic fatty liver patients with different genotypes of vitamin D receptor FokI polymorphism.,"BACKGROUND Vitamin D deficiency is prevalent in patients with non-alcoholic fatty liver disease (NAFLD), but there are debates on the usefulness of vitamin D treatment. The interindividual variations in response may be due to different genetic backgrounds. The present study evaluated the efficacy of calcitriol treatment in NAFLD patients with regard to the vitamin D receptor (VDR) genotypes of FokI polymorphism. METHODS The study was conducted on 128 NAFLD patients randomly divided into two groups and were subjected to intervention with 0.25 mcg calcitriol/day or placebo for 4 months, while anthropometric parameters, glycemic status, lipid profiles, inflammatory markers, liver enzymes, and fatty liver indices were measured. The ARMS-PCR method was used to genotype the VDR FokI polymorphism. RESULTS Calcitriol treatments along with weight loss and diet recommendations decreased the liver enzymes (AST, ALT, and ALP, p < 0.001 for all) and fatty liver indices (HSI, p < 0.01 and APRI, p < 0.001), compared to the baseline. But when the calcitriol effects were compared to the placebo group, only ALP decrease remained significant (17.5 IU. P = 0.02). The prevalent FokI variants in our population were FF (53.1%) and Ff genotype (45.3%). No significant interaction of FokI variants to the calcitriol effects was found except for ALP. The decrease in the ALP activity was higher in calcitriol-received patients with the Ff genotype (p = 0.05). CONCLUSIONS The FF and Ff variants of VDR FokI polymorphism did not interact with the effects of calcitriol on fatty liver, but the ALP was more responsive in subjects with the Ff variant. IRCT REGISTRATION NUMBER IRCT2017053034222N1 Registration date: 2017-06-28 - Retrospectively registered, https://en.irct.ir/trial/26203.",2021,"The decrease in the ALP activity was higher in calcitriol-received patients with the Ff genotype (p = 0.05). ","['128 NAFLD patients', 'non-alcoholic fatty liver patients with different genotypes of vitamin D receptor FokI polymorphism', 'subjects with the Ff variant', '2017-06-28 - Retrospectively registered, https://en.irct.ir/trial/26203', 'NAFLD patients with regard to the vitamin D receptor (VDR) genotypes of FokI polymorphism', 'patients with non-alcoholic fatty liver disease (NAFLD']","['placebo', 'intervention with 0.25 mcg calcitriol/day or placebo', 'calcitriol']","['anthropometric parameters, glycemic status, lipid profiles, inflammatory markers, liver enzymes, and fatty liver indices', 'liver enzymes (AST, ALT, and ALP', 'ALP activity', 'fatty liver indices']","[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0108082', 'cui_str': 'Vitamin D3 Receptor'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0006674', 'cui_str': 'Calcitriol'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",128.0,0.163881,"The decrease in the ALP activity was higher in calcitriol-received patients with the Ff genotype (p = 0.05). ","[{'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Yaghooti', 'Affiliation': 'Hyperlipidemia Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Ghanavati', 'Affiliation': 'Hyperlipidemia Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Seyed Saeed', 'Initials': 'SS', 'LastName': 'Seyedian', 'Affiliation': 'Alimentary Tract Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Bahman', 'Initials': 'B', 'LastName': 'Cheraghian', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Mohammadtaghvaei', 'Affiliation': 'Hyperlipidemia Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. ntaghvaie@gmail.com.'}]",BMC pharmacology & toxicology,['10.1186/s40360-021-00485-y'] 3131,33827649,Acupuncture for the treatment of diarrheal-predominant irritable bowel syndrome: study protocol for a pilot randomized controlled trial.,"BACKGROUND Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal diseases. Although acupuncture has become a common alternative therapy for IBS, there is insufficient evidence for its effectiveness. This study was designed to assess the efficacy and feasibility of acupuncture in the treatment of IBS. METHODS/DESIGN This is a multicenter randomized controlled clinical trial. According to the ratio of 1:1:1, 90 patients with irritable bowel syndrome will be randomly divided into specific acupoints (SA) group, non-specific acupoints (NSA) group, and non-acupoints (NA) group. All patients will be treated with acupuncture 12 times within 4 weeks and followed up for 8 weeks. The primary outcome is the response rate, the percentage of patients whose average value of worst abdominal pain is 30% better and the days of loose stool is 50% less than the baseline, at week 4 after randomization. The secondary outcomes include the response rates at other time points, IBS Symptom Severity Scale (IBS-SSS), Patient Health Questionnaire-9 depression scale (PHQ-9), IBS-Quality of Life scale (IBS-QOL), IBS Adequate Relief (IBS-AR), Abdominal Pain Score, Abdominal Bloating Score, Bristol Stool Score (BBS), blinding assessment, and credibility evaluation. Adverse events will be monitored and recorded during the trial. TRIAL REGISTRATION Chictr.org.cn ChiCTR2000030670. Registered on 9 March 2020.",2021,"The secondary outcomes include the response rates at other time points, IBS Symptom Severity Scale (IBS-SSS), Patient Health Questionnaire-9 depression scale (PHQ-9), IBS-Quality of Life scale (IBS-QOL), IBS Adequate Relief (IBS-AR), Abdominal Pain Score, Abdominal Bloating Score, Bristol Stool Score (BBS), blinding assessment, and credibility evaluation.","['diarrheal-predominant irritable bowel syndrome', '90 patients with irritable bowel syndrome']","['acupuncture', 'specific acupoints (SA) group, non-specific acupoints (NSA) group, and non-acupoints (NA', 'Acupuncture']","['response rate, the percentage of patients whose average value of worst abdominal pain', 'efficacy and feasibility', 'response rates at other time points, IBS Symptom Severity Scale (IBS-SSS), Patient Health Questionnaire-9 depression scale (PHQ-9), IBS-Quality of Life scale (IBS-QOL), IBS Adequate Relief (IBS-AR), Abdominal Pain Score, Abdominal Bloating Score, Bristol Stool Score (BBS), blinding assessment, and credibility evaluation', 'Adverse events']","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037052', 'cui_str': 'Sick sinus syndrome'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",90.0,0.216676,"The secondary outcomes include the response rates at other time points, IBS Symptom Severity Scale (IBS-SSS), Patient Health Questionnaire-9 depression scale (PHQ-9), IBS-Quality of Life scale (IBS-QOL), IBS Adequate Relief (IBS-AR), Abdominal Pain Score, Abdominal Bloating Score, Bristol Stool Score (BBS), blinding assessment, and credibility evaluation.","[{'ForeName': 'Ling-Yu', 'Initials': 'LY', 'LastName': 'Qi', 'Affiliation': 'International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, 100029, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, 100029, Beijing, China.'}, {'ForeName': 'Li-Qiong', 'Initials': 'LQ', 'LastName': 'Wang', 'Affiliation': 'International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, 100029, Beijing, China.'}, {'ForeName': 'Yan-Fen', 'Initials': 'YF', 'LastName': 'She', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Hebei University of Chinese Medicine, Shijiazhuang, 050299, China.'}, {'ForeName': 'Guang-Xia', 'Initials': 'GX', 'LastName': 'Shi', 'Affiliation': 'International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, 100029, Beijing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'School of Graduate, Chengdu University of Chinese Medicine, Chengdu, 610075, China.'}, {'ForeName': 'Li-Li', 'Initials': 'LL', 'LastName': 'Chi', 'Affiliation': 'Department of Spleen and Stomach, the Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, 250011, China.'}, {'ForeName': 'Bang-Qi', 'Initials': 'BQ', 'LastName': 'Wu', 'Affiliation': 'National Acupuncture and Moxibustion Clinical Medical Research Center, the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China.'}, {'ForeName': 'Jian-Feng', 'Initials': 'JF', 'LastName': 'Tu', 'Affiliation': 'International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, 100029, Beijing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, 100029, Beijing, China.'}, {'ForeName': 'Fang-Ting', 'Initials': 'FT', 'LastName': 'Yu', 'Affiliation': 'International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, 100029, Beijing, China.'}, {'ForeName': 'Jing-Wen', 'Initials': 'JW', 'LastName': 'Yang', 'Affiliation': 'International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, 100029, Beijing, China. yangjw0626@126.com.'}, {'ForeName': 'Cun-Zhi', 'Initials': 'CZ', 'LastName': 'Liu', 'Affiliation': 'International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, 100029, Beijing, China.'}]",Trials,['10.1186/s13063-021-05211-x'] 3132,33827639,"Effect of a prebiotic supplement on knee joint function, gut microbiota, and inflammation in adults with co-morbid obesity and knee osteoarthritis: study protocol for a randomized controlled trial.","BACKGROUND Osteoarthritis (OA) is a chronic and painful condition where the articular cartilage surfaces progressively degenerate, resulting in loss of function and progressive disability. Obesity is a primary risk factor for the development and progression of knee OA, defined as the ""metabolic OA"" phenotype. Metabolic OA is associated with increased fat deposits that release inflammatory cytokines/adipokines, thereby resulting in systemic inflammation which can contribute to cartilage degeneration. There is currently no cure for OA. Prebiotics are a type of dietary fiber that can positively influence gut microbiota thereby reducing systemic inflammation and offering protection of joint integrity in rodents. However, no human clinical trials have tested the effects of prebiotics in adults with obesity suffering from knee OA. Therefore, the purpose of this double-blind, placebo-controlled, randomized trial is to determine if prebiotic supplementation can, through positive changes in the gut microbiota, improve knee function and physical performance in adults with obesity and knee OA. METHODS Adults (n = 60) with co-morbid obesity (BMI > 30 kg/m 2 ) and knee OA (Kellgren-Lawrence grade II-III) will be recruited from the Alberta Hip and Knee Clinic and the Rocky Mountain Health Clinic and surrounding community of Calgary, Canada, and randomized (stratified by sex, BMI, and age) to prebiotic (oligofructose-enriched inulin; 16 g/day) or a calorie-matched placebo (maltodextrin) for 6 months. Anthropometrics, performance-based tests, knee pain, serum inflammatory markers and metabolomics, quality of life, and gut microbiota will be assessed at baseline, 3 months, 6 months (end of prebiotic supplementation), and 3 months following the end of the prebiotic supplementation. CLINICAL SIGNIFICANCE There is growing pressure on health care systems for aggressive OA treatment such as total joint replacement. Less aggressive, yet effective, conservative treatment options have the potential to address the growing prevalence of co-morbid obesity and knee OA by delaying the need for joint replacement or ideally preventing its need altogether. The results of this clinical trial will provide the first evidence regarding the efficacy of prebiotic supplementation on knee joint function and pain in adults with obesity and knee OA. If successful, the results may provide a simple, safe, and easy to adhere to intervention to reduce knee joint pain and improve the quality of life of adults with co-morbid knee OA and obesity. TRIAL REGISTRATION Clinical Trials.gov NCT04172688 . Registered on 21 November 2019.",2021,"Less aggressive, yet effective, conservative treatment options have the potential to address the growing prevalence of co-morbid obesity and knee OA by delaying the need for joint replacement or ideally preventing its need altogether.","['adults with co-morbid obesity and knee osteoarthritis', 'adults with obesity and knee OA', 'Adults (n\xa0', '60) with co-morbid obesity', 'adults with obesity suffering from knee OA']","['placebo', 'prebiotic supplementation', 'prebiotic supplement', 'calorie-matched placebo (maltodextrin']","['knee function and physical performance', 'knee joint pain', 'quality of life', 'knee joint function, gut microbiota, and inflammation', 'knee joint function and pain', 'Anthropometrics, performance-based tests, knee pain, serum inflammatory markers and metabolomics, quality of life, and gut microbiota']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}]",,0.217325,"Less aggressive, yet effective, conservative treatment options have the potential to address the growing prevalence of co-morbid obesity and knee OA by delaying the need for joint replacement or ideally preventing its need altogether.","[{'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Fortuna', 'Affiliation': 'Human Performance Laboratory, Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Hart', 'Affiliation': 'McCaig Institute for Bone and Joint Health, Department of Surgery, and Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Keith A', 'Initials': 'KA', 'LastName': 'Sharkey', 'Affiliation': 'Hotchkiss Brain Institute and Snyder Institute for Chronic Diseases, Department of Physiology and Pharmacology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Schachar', 'Affiliation': 'Rocky Mountain Health Clinic, Calgary, Alberta, Canada.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Johnston', 'Affiliation': 'Division of Hip and Knee Reconstruction, Department of Surgery, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Raylene A', 'Initials': 'RA', 'LastName': 'Reimer', 'Affiliation': 'Faculty of Kinesiology and Department of Biochemistry and Molecular Biology, Cumming School of Medicine, University of Calgary, 2500 University Dr. NW, Calgary, Alberta, Canada. reimer@ucalgary.ca.'}]",Trials,['10.1186/s13063-021-05212-w'] 3133,33827631,Impact and cost-effectiveness evaluation of a community-based rehabilitation intervention on quality of life among Chinese adults with hearing loss: study protocol for a randomized controlled trial.,"BACKGROUND Hearing loss is quite prevalent and can be related to people's quality of life. To our knowledge, there are limited studies assessing the efficacy of hearing interventions on quality of life in adults. Therefore, we aim to conduct a randomized controlled trial (RCT) to determine the impact and cost-effectiveness of community-based hearing rehabilitation on quality of life among Chinese adults with hearing loss. METHODS/DESIGN In this two-arm feasibility study, participants aged 16 and above with some degree of hearing loss (n = 464) will be recruited from Linyi City, Shandong Province. They are randomly assigned to the treatment group or the control group. Those in the treatment group are prescribed with hearing aids, while those in the control group receive no intervention. Reinstruction in use of devices is provided for the treatment group during booster visits held 12 months post-randomization or unscheduled interim visits when necessary. Data are collected at baseline and the follow-up 20 months later. The primary outcome is changes in quality of life over a 20-month study period. Secondary outcomes include sub-dimensions in quality of life, physical functioning, chronic diseases, cognitive function, depression, social support, hospitalizations, falls, and healthcare costs. Finally, we will evaluate whether hearing aids intervention is cost-effective to apply in a large scale. DISCUSSION The trial is designed to evaluate the impact and cost-effectiveness of a community-based rehabilitation intervention on quality of life among Chinese adults with hearing loss. We hope that it would help improve the well-being for Chinese adults and provide references in policy and practice for China and other countries. TRIAL REGISTRATION Chinese Clinical Trial Registry ChiCTR1900024739 . Registered on 26 July 2019.",2021,The trial is designed to evaluate the impact and cost-effectiveness of a community-based rehabilitation intervention on quality of life among Chinese adults with hearing loss.,"['Chinese adults with hearing loss', 'participants aged 16 and above with some degree of hearing loss (n\u2009=\u2009464) will be recruited from Linyi City, Shandong Province', 'adults']","['community-based rehabilitation intervention', 'hearing interventions', 'community-based hearing rehabilitation', 'hearing aids intervention']","['quality of life', 'sub-dimensions in quality of life, physical functioning, chronic diseases, cognitive function, depression, social support, hospitalizations, falls, and healthcare costs']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0018768', 'cui_str': 'Hearing aid'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}]",,0.0873767,The trial is designed to evaluate the impact and cost-effectiveness of a community-based rehabilitation intervention on quality of life among Chinese adults with hearing loss.,"[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': 'School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Dawei', 'Initials': 'D', 'LastName': 'Zhu', 'Affiliation': 'China Center for Health Development Studies, Peking University, Beijing, China.'}, {'ForeName': 'Siyuan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Xuefeng', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'School of Management, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Gong', 'Affiliation': 'China Rehabilitation Research Center for Hearing and Speech Impairment, Beijing, China.'}, {'ForeName': 'Juncheng', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Linyi Center for Disease Control and Prevention, Linyi, Shandong, China.'}, {'ForeName': 'Huibin', 'Initials': 'H', 'LastName': 'Zuo', 'Affiliation': 'Linyi Center for Disease Control and Prevention, Linyi, Shandong, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Linyi Rehabilitation Hospital, Linyi, Shandong, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'He', 'Affiliation': 'China Center for Health Development Studies, Peking University, Beijing, China. phe@pku.edu.cn.'}]",Trials,['10.1186/s13063-021-05228-2'] 3134,33827537,Short-term effects of mobilization on oxygenation in patients after open surgery for pancreatic cancer: a randomized controlled trial.,"BACKGROUND Despite the unequivocal role of progressive mobilization in post-surgical patient management, its specific effects and timing, particularly after abdominal surgery, remain debated. This study's aim was to examine the short-term effects of mobilization on oxygenation in hemodynamically stable patients after open surgery for pancreatic cancer. METHODS A randomized controlled clinical trial was conducted in which patients (n = 83) after open pancreatic surgery were randomized to either the same-day mobilization group (mobilized when hemodynamically stable within four hours after surgery) or the next-day mobilization group (mobilized first time in the morning of the first post-operative day). Mobilization was prescribed and modified based on hemodynamic and subjective responses with the goal of achieving maximal benefit with minimal risk. Blood gas samples were taken three times the evening after surgery; and before and after mobilization on the first post-operative day. Spirometry was conducted pre-operatively and on the first post-operative day. Adverse events and length of stay in postoperative intensive care were also recorded. RESULTS With three dropouts, 80 patients participated (40 per group). All patients in the same-day mobilization group, minimally sat over the edge of the bed on the day of surgery and all patients (both groups) minimally sat over the edge of the bed the day after surgery. Compared with patients in the next-day mobilization group, patients in the same-day mobilization group required lower FiO 2 and had higher SaO 2 /FiO 2 at 1800 h on the day of surgery (p < .05). On the day after surgery, FiO 2, SaO 2 /FiO 2, PaO 2 /FiO 2 , and alveolar-arterial oxygen gradient, before and after mobilization, were superior in the same-day mobilization group (p < 0.05). No differences were observed between groups in PCO 2 , pH, spirometry or length stay in postoperative intensive care. CONCLUSIONS Compared with patients after open pancreatic surgery in the next-day mobilization group, those in the same-day mobilization group, once hemodynamically stable, improved oxygenation to a greater extent after mobilization. Our findings support prescribed progressive mobilization in patients after pancreatic surgery (when hemodynamically stable and titrated to their individual responses and safety considerations), on the same day of surgery to augment oxygenation, potentially helping to reduce complications and hasten functional recovery. TRIAL REGISTRATION This prospective RCT was carried out at the Sahlgrenska University Hospital, Sweden. The study was approved by the Regional Ethical Review Board in Gothenburg (Registration number: 437-17). TRIAL REGISTRATION ""FoU in Sweden"" (Research and Development in Sweden, URL: https://www.researchweb.org/is/vgr ) id: 238701 Registered 13 December 2017 and Clinical Trials (URL:clinicaltrials.gov) NCT03466593. Registered 15 March 2018.",2021,"No differences were observed between groups in PCO 2 , pH, spirometry or length stay in postoperative intensive care. ","['Sahlgrenska University Hospital, Sweden', 'Sweden, URL: https://www.researchweb.org/is/vgr ', 'patients after open surgery for pancreatic cancer', 'hemodynamically stable patients after open surgery for pancreatic cancer', 'patients (n\u2009=\u200983) after open pancreatic surgery']",['same-day mobilization group (mobilized when hemodynamically stable within four hours after surgery) or the next-day mobilization'],"['PCO 2 , pH, spirometry or length stay in postoperative intensive care', 'Adverse events and length of stay in postoperative intensive care', 'alveolar-arterial oxygen gradient', 'Blood gas samples']","[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C3541384', 'cui_str': 'URL'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0578150', 'cui_str': 'Hemodynamically stable'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0578150', 'cui_str': 'Hemodynamically stable'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3203470', 'cui_str': 'Alveolar-arterial oxygen gradient'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",80.0,0.113737,"No differences were observed between groups in PCO 2 , pH, spirometry or length stay in postoperative intensive care. ","[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Fagevik Olsén', 'Affiliation': 'Department of Health and Rehabilitation/Physiotherapy, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. monika.fagevik-olsen@vgregion.se.'}, {'ForeName': 'Suada', 'Initials': 'S', 'LastName': 'Becovic', 'Affiliation': 'Department of Health and Rehabilitation/Physiotherapy, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Dean', 'Affiliation': 'Department of Physical Therapy, Faculty of Medicine, University of British Columbia, Vancouver, Canada.'}]",BMC surgery,['10.1186/s12893-021-01187-2'] 3135,33830175,Pathways Through Which Health Literacy Is Linked to Parental Oral Health Behavior in an American Indian Tribe.,"BACKGROUND Health literacy (HL) is the ""ability to find, understand, evaluate and put information to use to improve decision making and, ultimately, improve health and quality of life."" Parents with limited HL are less likely to follow recommended parental oral health behaviors. PURPOSE We tested a theoretical framework designed to clarify mechanisms through which HL may influence parental oral health behavior. The framework proposed that HL: (a) has a direct effect on parental oral health knowledge, beliefs (i.e. self-efficacy; perceived susceptibility, severity, benefits, barriers), and behavior; (b) influences beliefs indirectly through knowledge; and (c) influences behavior indirectly through knowledge and beliefs. METHODS We analyzed cross-sectional data from a randomized controlled trial designed to reduce dental decay in American Indian children (N = 521). Parents completed survey questions assessing sociodemographic characteristics, HL, and parental oral health knowledge, beliefs, and behavior. Path analysis was used to test the framework. RESULTS HL exerted significant direct effects on knowledge and beliefs but not behavior. HL had significant indirect effects on all beliefs through knowledge. Significant indirect effects of HL on behavior occurred through self-efficacy (estimate: 0.99, 95% CI: 0.42, 1.83, p = .005), perceived barriers (estimate: 0.73, 95% CI: 0.29, 1.43, p = .010), knowledge to self-efficacy (estimate: 0.57, 95% CI: .31, 0.98, p = .001), and knowledge to perceived barriers (estimate: 0.24, 95% CI: 0.09, 0.47, p = .012). CONCLUSIONS HL exerted an indirect effect on parental oral health behavior, with knowledge, self-efficacy, and perceived barriers being the primary constructs linking HL to behavior.",2021,"Significant indirect effects of HL on behavior occurred through self-efficacy (estimate: 0.99, 95% CI: 0.42, 1.83, p = .005), perceived barriers (estimate:",['American Indian children (N = 521'],['HL'],"['health and quality of life', 'behavior occurred through self-efficacy', 'parental oral health behavior, with knowledge, self-efficacy', 'knowledge to self-efficacy', 'survey questions assessing sociodemographic characteristics, HL, and parental oral health knowledge, beliefs, and behavior', 'knowledge and beliefs']","[{'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C2362527', 'cui_str': 'Health Literacy'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",521.0,0.0224564,"Significant indirect effects of HL on behavior occurred through self-efficacy (estimate: 0.99, 95% CI: 0.42, 1.83, p = .005), perceived barriers (estimate:","[{'ForeName': 'Angela G', 'Initials': 'AG', 'LastName': 'Brega', 'Affiliation': 'Centers for American Indian and Alaska Native Health, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Johnson', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Schmiege', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Anne R', 'Initials': 'AR', 'LastName': 'Wilson', 'Affiliation': 'Department of Pediatric Dentistry, School of Dental Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Luohua', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Epidemiology, School of Medicine, University of California Irvine, Irvine, CA, USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Albino', 'Affiliation': 'Centers for American Indian and Alaska Native Health, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaab006'] 3136,33830091,Adverse Childhood Experiences and Chronic Pain Rehabilitation Treatment Outcomes in Adults.,"OBJECTIVES Adverse childhood experiences (ACEs) are commonly reported by individuals with chronic pain. However, little is known about how ACE exposure influences treatment outcomes. The goal of the current study was to evaluate group and treatment-related differences among adults with varying levels of ACE exposure participating in a pain rehabilitation treatment program. METHODS Adult participants (N=269) were categorized as 0 ACEs (n=65), 1 to 2 ACEs (n=87), or ≥3 ACEs (n=117). Participants completed self-report measures of pain, physical functioning, and psychosocial functioning at intake and discharge from a 10-week interdisciplinary pain rehabilitation program. RESULTS ACE exposure was frequently endorsed in this sample, with the majority of participants (78.5%) reporting at least 1 form of childhood adversity. Adults in the ≥3 ACEs group reported a greater level of impairment in mental health symptoms and adjustment to chronic pain; however, all groups endorsed treatment improvements and there were no differences in response to treatment. There were also no differences between groups on measures of pain or physical functioning at intake or discharge. DISCUSSION ACE exposure appears common among treatment-seeking adults with chronic pain and is associated with increased clinical complexity. However, adults with and without exposure to ACEs endorsed significant improvements in pain and functioning following participation in an interdisciplinary pain rehabilitation program. This model of treatment may be especially well situated to address the biopsychosocial contributions to pain among those with a history of adversity.",2021,"Adults in the ≥3 ACEs group reported a greater level of impairment in mental health symptoms and adjustment to chronic pain; however, all groups endorsed treatment improvements and there were no differences in response to treatment.","['Adults', 'Adult participants (N=269) were categorized as 0 ACEs (n=65), 1 to 2 ACEs (n=87), or ≥3 ACEs (n=117', 'individuals with chronic pain', 'adults with varying levels of ACE exposure participating in a pain rehabilitation treatment program']",[],"['pain, physical functioning, and psychosocial functioning at intake and discharge', 'pain or physical functioning at intake or discharge', 'level of impairment in mental health symptoms and adjustment to chronic pain', 'pain and functioning']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4296616', 'cui_str': 'Adverse Childhood Experiences'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0458264', 'cui_str': 'Pain rehabilitation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]",269.0,0.161078,"Adults in the ≥3 ACEs group reported a greater level of impairment in mental health symptoms and adjustment to chronic pain; however, all groups endorsed treatment improvements and there were no differences in response to treatment.","[{'ForeName': 'Julia R', 'Initials': 'JR', 'LastName': 'Craner', 'Affiliation': 'Pain Rehabilitation Program, Mary Free Bed Rehabilitation Hospital.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Lake', 'Affiliation': 'Pain Rehabilitation Program, Mary Free Bed Rehabilitation Hospital.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000924'] 3137,33830058,An Individual Cognitive Stimulation Therapy App for People With Dementia and Their Carers: Protocol for a Feasibility Randomized Controlled Trial.,"BACKGROUND There is a need for more resources to support the cognition and quality of life of people with dementia. The individual cognitive stimulation therapy (iCST) app aims to provide cognitive stimulation and social interaction to people with dementia and carers through interactive touchscreen technology. The iCST app has been developed according to the principles of CST and iCST, which have previously shown to improve the cognition and quality of life of people with dementia and benefit the relationship between the person with dementia and his/her carer. The iCST app has also shown to improve the quality of the carer's life. OBJECTIVE The aim of this study is to evaluate the usability of the iCST app intervention and the feasibility of conducting a full-scale randomized controlled trial (RCT) to assess the clinical effectiveness of the iCST app intervention compared to that of treatment-as-usual for people with mild-to-moderate dementia. METHODS We aim to recruit 60 people with mild-to-moderate dementia and their informal carers as dyads in a multi-center feasibility RCT with a treatment-as-usual control group. Both parties must be able to provide informed consent and participate in the intervention. Dyads will complete a baseline assessment that will include cognition and quality of life measures and they will subsequently be randomized (1:1) to the iCST app intervention in addition to usual care or to usual care only. All participants will be followed up at 5 weeks and at 11 weeks after the baseline assessments. A range of feasibility outcomes will be assessed, including recruitment and retention rates, intervention fidelity and usability, and acceptability of the outcome measures. A sample of the experimental group will be invited to a semistructured posttrial interview to further examine the experience of using the iCST app. RESULTS This study received funding in May 2015 and obtained ethical approval in March 2018. Data collection began in November 2018 and was completed in March 2020 with a total of 61 dyads recruited. Data analyses are in progress and the final results are expected to be available in the spring of 2021. CONCLUSIONS This study will investigate whether it is feasible to conduct a full-scale RCT to evaluate the clinical effectiveness of the iCST app in comparison to that of usual care alone. In addition, this study will examine the usability of the iCST app. The data will provide information on potential modifications to be made to the intervention, study design, and study process. TRIAL REGISTRATION ClinicalTrials.gov NCT03282877; https://clinicaltrials.gov/ct2/show/NCT03282877. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/24628.",2021,"A range of feasibility outcomes will be assessed, including recruitment and retention rates, intervention fidelity and usability, and acceptability of the outcome measures.","['people with dementia and carers through interactive touchscreen technology', '60 people with mild-to-moderate dementia and their informal carers as dyads in a multi-center feasibility RCT with a treatment-as-usual control group', 'People With Dementia and Their Carers', 'people with mild-to-moderate dementia', 'Data collection began in November 2018 and was completed in March 2020 with a total of 61 dyads recruited']","['individual cognitive stimulation therapy (iCST', 'iCST', 'iCST app intervention']","['recruitment and retention rates, intervention fidelity and usability, and acceptability of the outcome measures']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150174', 'cui_str': 'Cognitive stimulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}]",61.0,0.181788,"A range of feasibility outcomes will be assessed, including recruitment and retention rates, intervention fidelity and usability, and acceptability of the outcome measures.","[{'ForeName': 'Harleen Kaur', 'Initials': 'HK', 'LastName': 'Rai', 'Affiliation': 'Division of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Schneider', 'Affiliation': 'School of Sociology and Social Policy, Law and Social Sciences Building, \xa0University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Orrell', 'Affiliation': 'Division of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham, Nottingham, United Kingdom.'}]",JMIR research protocols,['10.2196/24628'] 3138,33830025,Long-term Outcomes with Nonmyeloablative HLA-Identical Related Hematopoietic Cell Transplantation Using Tacrolimus and Mycophenolate Mofetil for Graft-versus-Host Disease Prophylaxis.,"Nonmyeloablative allogeneic hematopoietic cell transplantation (HCT) from HLA-identical related donors using cyclosporine (CSP) and mycophenolate mofetil (MMF) for postgrafting immunosuppression is effective therapy for hematologic cancers. However, graft-versus-host-disease (GVHD) remains a major cause of morbidity and mortality. Pilot data suggested lower acute GVHD incidence with tacrolimus/MMF compared to historical experience using CSP/MMF after nonmyeloablative HCT. In a phase II multicenter trial, we evaluated the effect of tacrolimus/MMF for GVHD prophylaxis after HLA-identical related donor peripheral blood HCT in patients with hematologic malignancies (n = 150) using conditioning with 2 Gy total body irradiation (TBI) for patients with a preceding (within 6 months) planned autologous HCT (n = 50) or combined with 90 mg/m 2 fludarabine for those without recent autologous HCT (n = 100). Oral tacrolimus was given from days -3 to 56 (tapered by day +180 if no GVHD). Oral MMF was given from days 0 to 27. Patient median age was 57 (range, 20 to 74) years. The cumulative incidences (CI) of day 100 grade II to IV and III to IV acute GVHD were 27% and 4%, respectively. With median follow-up of 10.3 (range, 3.1 to 14.5) years, the 5-year CI of chronic extensive GVHD was 48%. One-year and 5-year estimates of nonrelapse mortality, relapse/progression, survival, and progression-free survival were 9% and 13%, 35% and 50%, 73% and 53%, and 56% and 37%, respectively. GVHD prophylaxis with tacrolimus/MMF resulted in a low risk of acute GVHD and compared favorably with results from a concurrent trial using CSP/MMF. A randomized phase III trial to investigate tacrolimus/MMF versus CSP/MMF in nonmyeloablative HCT is warranted.",2021,GVHD prophylaxis with tacrolimus/MMF resulted in a low risk of acute GVHD and compared favorably with results from a concurrent trial using CSP/MMF.,"['Patient median age was 57 (range, 20 to 74) years', 'patients with hematologic malignancies (n\xa0=\xa0150) using']","['Nonmyeloablative allogeneic hematopoietic cell transplantation (HCT', 'cyclosporine (CSP) and mycophenolate mofetil (MMF', 'tacrolimus/MMF', 'Nonmyeloablative HLA-Identical Related Hematopoietic Cell Transplantation Using Tacrolimus and Mycophenolate Mofetil', 'Oral tacrolimus', 'autologous HCT (n\xa0=\xa050) or combined with 90 mg/m 2 fludarabine for those without recent autologous HCT', 'Oral MMF', 'conditioning with 2 Gy total body irradiation (TBI', 'tacrolimus/MMF versus CSP/MMF']","['cumulative incidences (CI) of day 100 grade II to IV and III to IV acute GVHD', 'acute GVHD incidence', '5-year CI of chronic extensive GVHD', 'nonrelapse mortality, relapse/progression, survival, and progression-free survival', 'low risk of acute GVHD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0019630', 'cui_str': 'Class II Histocompatibility Antigens'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0059985', 'cui_str': 'fludarabine'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0043162', 'cui_str': 'Total body irradiation'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0018133', 'cui_str': 'Graft versus host disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}]",,0.034884,GVHD prophylaxis with tacrolimus/MMF resulted in a low risk of acute GVHD and compared favorably with results from a concurrent trial using CSP/MMF.,"[{'ForeName': 'Masumi', 'Initials': 'M', 'LastName': 'Ueda Oshima', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington; Division of Medical Oncology, Department of Medicine, University of Washington, Seattle, Washington. Electronic address: mueda@fredhutch.org.'}, {'ForeName': 'Barry E', 'Initials': 'BE', 'LastName': 'Storer', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Huiying', 'Initials': 'H', 'LastName': 'Qiu', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Chauncey', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, University of Washington, Seattle, Washington; VA Puget Sound Health Care System, Seattle, Washington.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Asch', 'Affiliation': 'Intermountain Healthcare, Salt Lake City, Utah.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Boyer', 'Affiliation': 'University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Giaccone', 'Affiliation': 'Torino University, Torino, Italy.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Flowers', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington; Division of Medical Oncology, Department of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Mielcarek', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington; Division of Medical Oncology, Department of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Storb', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington; Division of Medical Oncology, Department of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Maloney', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington; Division of Medical Oncology, Department of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Brenda M', 'Initials': 'BM', 'LastName': 'Sandmaier', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington; Division of Medical Oncology, Department of Medicine, University of Washington, Seattle, Washington.'}]",Transplantation and cellular therapy,['10.1016/j.jtct.2020.10.016'] 3139,33832406,Atypical antipsychotics in the treatment of patients with a dual diagnosis of schizophrenia spectrum disorders and substance use disorders: the results of a randomized comparative study.,"The article presents the results of a randomized comparative study of Aripiprazole and Quetiapine in the treatment of patients with a dual diagnosis: schizophrenia and substance use disorders. During the study, 90 of the 266 male patients were screened. Among them, 54 individuals (60%) had a previously established diagnosis of mental disorder and 36 patients (40%) had no established psychiatric diagnosis. They were randomly randomized into three groups of 30 patients, each receiving an antipsychotic: Aripiprazole at a dose of up to 20 mg daily, Quetiapine at a dose of up to 600 mg daily, or Haloperidol at a dose of up to 30 mg daily. The efficacy of Aripiprazole and Quetiapine was evaluated using the following scales: PANSS, BPRS, VAS, and Substance Craving Scale (SCS). Drug safety was assessed by the development of adverse events, serious adverse events, or adverse reactions. Study results demonstrated the efficacy of atypical antipsychotics in the three groups. Analysis of independent variables showed significant differences between Aripiprazole and Haloperidol in PANSS and BPRS scores by Visit 4, in VAS scores by Visit 3, and in SCS scores by Visit 2. Intergroup analysis of independent variables showed significant differences between Quetiapine and Haloperidol in PANSS, VAS, and SCS scores by Visit 4. Intergroup analysis of independent variables showed significant differences between Aripiprazole and Quetiapine in the VAS and SCS scores. The correlation analysis allowed drawing conclusions about the close connection of the symptoms of schizophrenia and substance use disorders in patients with a dual diagnosis.",2021,"Analysis of independent variables showed significant differences between Aripiprazole and Haloperidol in PANSS and BPRS scores by Visit 4, in VAS scores by Visit 3, and in SCS scores by Visit 2.","['patients with a dual diagnosis: schizophrenia and substance use disorders', 'patients with a dual diagnosis', 'patients with a dual diagnosis of schizophrenia spectrum disorders and substance use disorders', '266 male patients were screened', '54 individuals (60%) had a previously established diagnosis of mental disorder and 36 patients (40%) had no established psychiatric diagnosis']","['Aripiprazole and Quetiapine', 'Quetiapine and Haloperidol', 'Quetiapine', 'antipsychotic: Aripiprazole', 'Atypical antipsychotics', 'Aripiprazole and Haloperidol', 'Aripiprazole', 'Haloperidol']","['efficacy of atypical antipsychotics', 'Drug safety', 'VAS scores', 'adverse events, serious adverse events, or adverse reactions', 'PANSS and BPRS scores', 'PANSS, VAS, and SCS scores', 'SCS scores', 'VAS and SCS scores', 'BPRS, VAS, and Substance Craving Scale (SCS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206308', 'cui_str': 'Dual Diagnosis'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332139', 'cui_str': 'Established diagnosis'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0376338', 'cui_str': 'Psychiatric Diagnosis'}]","[{'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0205182', 'cui_str': 'Atypical'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205182', 'cui_str': 'Atypical'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",266.0,0.0168429,"Analysis of independent variables showed significant differences between Aripiprazole and Haloperidol in PANSS and BPRS scores by Visit 4, in VAS scores by Visit 3, and in SCS scores by Visit 2.","[{'ForeName': 'V Yu', 'Initials': 'VY', 'LastName': 'Skryabin', 'Affiliation': 'Moscow Research and Practical Centre on Addictions of the Moscow Department of Healthcare, Moscow, Russia.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Vinnikova', 'Affiliation': 'Moscow Research and Practical Centre on Addictions of the Moscow Department of Healthcare, Moscow, Russia.'}, {'ForeName': 'E V', 'Initials': 'EV', 'LastName': 'Ezhkova', 'Affiliation': 'Moscow Research and Practical Centre on Addictions of the Moscow Department of Healthcare, Moscow, Russia.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Titkov', 'Affiliation': 'Psychiatry and Psychotherapy Division, European Medical Centre, Moscow, Russia.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Bulatova', 'Affiliation': 'Moscow Research and Practical Centre on Addictions of the Moscow Department of Healthcare, Moscow, Russia.'}]",Journal of addictive diseases,['10.1080/10550887.2021.1905589'] 3140,33832384,Mitigating medical student stress and anxiety: Should schools mandate participation in wellness intervention programs?,"PURPOSE Medical students are at increased risk of poor mental health and need to regularly engage in preventive programs to maintain well-being. However, many do not and it remains an open question whether these programs should be mandatory. We implemented a RCT to examine the effectiveness of assigning medical students to a wellness intervention on adherence to engagement in the assigned intervention and on psychological and academic outcomes. METHOD Medical students participated in a 12-week randomized controlled intervention involving one-hour wellness sessions of either (1) yoga; (2) mindfulness; or (3) walking, held twice-weekly. Students completed standardized psychological assessments at baseline and following the intervention. RESULTS Students randomized to the wellness intervention group engaged in more minutes of assigned activities than students randomized to the control. There was a significant difference in the change from pre- to post- intervention on measures of state anxiety and perceived stress, with better outcomes for the intervention group. CONCLUSIONS The assignment of twice-weekly wellness intervention sessions protects medical students from state anxiety and perceived stress with no negative impact on academic performance. Students adhered to the sessions and reported enjoying the sessions once trying them. Actual engagement is more important than wellness activity type.",2021,"There was a significant difference in the change from pre- to post- intervention on measures of state anxiety and perceived stress, with better outcomes for the intervention group. ",['Medical students participated in a 12-week randomized'],"['controlled intervention involving one-hour wellness sessions of either (1) yoga; (2) mindfulness; or (3) walking, held twice-weekly', 'wellness intervention']","['standardized psychological assessments', 'state anxiety and perceived stress']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}]","[{'cui': 'C0204452', 'cui_str': 'Psychological assessment'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",,0.0161254,"There was a significant difference in the change from pre- to post- intervention on measures of state anxiety and perceived stress, with better outcomes for the intervention group. ","[{'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Waechter', 'Affiliation': ""School of Medicine, St. George's University, St. George, Grenada.""}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Stahl', 'Affiliation': 'Emergency Medicine, Brookdale University Hospital and Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Rabie', 'Affiliation': ""Department of Educational Services, St. George's University, St. George, Grenada.""}, {'ForeName': 'Bora', 'Initials': 'B', 'LastName': 'Colak', 'Affiliation': 'Westchester Medical Center/New York Medical College, Valhalla, NY, USA.'}, {'ForeName': 'Debbi', 'Initials': 'D', 'LastName': 'Johnson-Rais', 'Affiliation': 'Division of Student Affairs and Enrollment Management, College of Science, Florida Atlantic University, Boca Raton, FL, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Landon', 'Affiliation': ""Psychological Services Center, School of Medicine, St. George's University, St. George, Grenada.""}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Petersen', 'Affiliation': 'Global Medical Writing and Translation, Kent, WA, USA.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Davari', 'Affiliation': ""School of Medicine, St. George's University, St. George, Grenada.""}, {'ForeName': 'Thinn', 'Initials': 'T', 'LastName': 'Zaw', 'Affiliation': ""School of Medicine, St. George's University, St. George, Grenada.""}, {'ForeName': 'Kesava', 'Initials': 'K', 'LastName': 'Mandalaneni', 'Affiliation': ""School of Medicine, St. George's University, St. George, Grenada.""}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Punch', 'Affiliation': 'Windward Islands Research and Education Foundation, St. George, Grenada.'}]",Medical teacher,['10.1080/0142159X.2021.1902966'] 3141,33832352,Dapagliflozin and Recurrent Heart Failure Hospitalizations in Heart Failure with Reduced Ejection Fraction: An Analysis of DAPA-HF.,"Background: Patients with heart failure and reduced ejection fraction (HFrEF) will experience multiple hospitalizations for heart failure during the course of their disease. We assessed the efficacy of dapagliflozin on reducing the rate of total (i.e. first and repeat) hospitalizations for heart failure in the Dapagliflozin and Prevention of Adverse-outcomes in Heart Failure trial (DAPA-HF). Methods: The total number of HF hospitalizations and cardiovascular deaths was examined using the proportional rates approach of Lei-Wei-Ying-Yang (LWYY) and a joint frailty model for each of recurrent HF hospitalizations and time to cardiovascular death. Variables associated with the risk of recurrent hospitalizations were explored in a multivariable LWYY model. Results: Of 2371 participants randomized to placebo, 318 experienced 469 hospitalizations for heart failure among; of 2373 assigned to dapagliflozin, 230 patients experienced 340 admissions. In a multivariable model factors associated with a higher risk of recurrent HF hospitalizations included higher heart rate, higher NT-proBNP and NYHA class. In the LWYY model the rate ratio for the effect of dapagliflozin on recurrent HF hospitalizations or CV death was 0.75 (95%CI 0.65-0.88), p=0.0002. In the joint frailty model, rate ratio for total HF hospitalizations was 0.71 (95% CI 0.61-0.82), p<0.0001 while for cardiovascular death the hazard ratio was 0.81(95%CI 0.67-0.98), p=00282. Conclusions: Dapagliflozin reduced the risk of total (first and repeat) HF hospitalizations and cardiovascular death. Time-to-first event analysis underestimated the benefit of dapagliflozin in HFrEF. Clinical Trial Registration: URL: https://www.clinicaltrials.gov Unique Identifier: NCT03036124.",2021,"In the joint frailty model, rate ratio for total HF hospitalizations was 0.71 (95% CI 0.61-0.82), p<0.0001 while for cardiovascular death the hazard ratio was 0.81(95%CI 0.67-0.98), p=00282. ","['Patients with heart failure and reduced ejection fraction (HFrEF) will experience multiple hospitalizations for heart failure during the course of their disease', 'Heart Failure with Reduced Ejection Fraction', ' 318 experienced 469 hospitalizations for heart failure among; of 2373 assigned to dapagliflozin, 230 patients experienced 340 admissions', '2371 participants randomized to']","['dapagliflozin', 'Dapagliflozin', 'placebo', 'URL']","['recurrent HF hospitalizations or CV death', 'risk of total (first and repeat', 'rate ratio for total HF hospitalizations', 'risk of recurrent hospitalizations', 'HF hospitalizations and cardiovascular death', 'total number of HF hospitalizations and cardiovascular deaths']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3541384', 'cui_str': 'URL'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",2371.0,0.51764,"In the joint frailty model, rate ratio for total HF hospitalizations was 0.71 (95% CI 0.61-0.82), p<0.0001 while for cardiovascular death the hazard ratio was 0.81(95%CI 0.67-0.98), p=00282. ","[{'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Center for Heart Diseases, University Hospital, Wroclaw Medical University, Poland.'}, {'ForeName': 'Kieran F', 'Initials': 'KF', 'LastName': 'Docherty', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Samvel B', 'Initials': 'SB', 'LastName': 'Gasparyan', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'The Department of Medicine, Saarland University Hospital, Homburg-Saar, Germany.'}, {'ForeName': 'Chern-En', 'Initials': 'CE', 'LastName': 'Chang', 'Affiliation': 'Division of Cardiology, Taipei Veterans General Hospital and National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Akshay S', 'Initials': 'AS', 'LastName': 'Desai', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Howlett', 'Affiliation': 'Cumming School of Medicine and Libin Cardiovascular Institute, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Kitakaze', 'Affiliation': 'Cardiovascular Division of Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Petrie', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Bengtsson', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Sjöstrand', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute, University of Missouri, Kansas City, MO & The George Institute for Global Health, University of New South Wales, Sydney, Australia.""}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Martinez', 'Affiliation': 'Universidad Nacional de Córdoba, Córdoba, Argentina.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}]",Circulation,['10.1161/CIRCULATIONAHA.121.053659'] 3142,33832312,Effect of the theory of planned behavior on primipara breastfeeding.,"BACKGROUND Breastfeeding is the most effective way to provide food for the healthy growth and development of babies. It has been reported in the literature that interventions on parturients, with the theory of planned behavior (TPB) as the guiding framework, can achieve good results. The purpose of the present study was to explore the effect of the TPB on primipara breastfeeding. METHODS A total of 70 primiparas, who were given regular intervention mode at Haian People's Hospital from May 2017 to May 2018, were selected as the control group, and a total of 70 primiparas, who were given the TPB model from June 2018 to June 2019, were selected as the observation group. Exclusive breastfeeding rates, continuous breastfeeding rates, and breastfeeding confidence and breastfeeding impact factors were compared between the two groups. RESULTS After the intervention, the pure breastfeeding rates of the observation group at discharge, 1 month after delivery, and 4 months after delivery were higher than those of the control group (P<0.05). After intervention, the continuous breastfeeding rates of the observation group was higher than that of the control group at 4 months after delivery (P<0.05). After intervention, the skill dimension, inner activity dimension, and total score of the observation group were higher than those of the control group (P<0.05). After intervention, scores of attitude, perceptual behavior control, and knowledge in the observation group were higher than those of the control group (P<0.05). CONCLUSIONS The application of the TPB to primipara breastfeeding can significantly increase the rate of exclusive breastfeeding and continuous breastfeeding, and effectively improve the impact factors of breastfeeding.",2021,"After intervention, the continuous breastfeeding rates of the observation group was higher than that of the control group at 4 months after delivery (P<0.05).","[""70 primiparas, who were given regular intervention mode at Haian People's Hospital from May 2017 to May 2018, were selected as the control group, and a total of 70 primiparas, who were given the TPB model from June 2018 to June 2019, were selected as the observation group""]",['TPB'],"['skill dimension, inner activity dimension, and total score', 'continuous breastfeeding rates', 'pure breastfeeding rates', 'rate of exclusive breastfeeding and continuous breastfeeding', 'Exclusive breastfeeding rates, continuous breastfeeding rates, and breastfeeding confidence and breastfeeding impact factors', 'scores of attitude, perceptual behavior control, and knowledge']","[{'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0376287', 'cui_str': 'Behavioral Manipulation'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0105849,"After intervention, the continuous breastfeeding rates of the observation group was higher than that of the control group at 4 months after delivery (P<0.05).","[{'ForeName': 'Yingping', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Obstetrics, Haian People's Hospital, Nantong, China.""}, {'ForeName': 'Ruifang', 'Initials': 'R', 'LastName': 'Yuan', 'Affiliation': ""Department of Obstetrics, Jiangyin People's Hospital, Wuxi, China. 755801652@qq.com.""}, {'ForeName': 'Haiying', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': ""Department of Gynaecology, Yangzhou Second People's Hospital, Yangzhou, China. haiying_ma@163.com.""}]",Annals of palliative medicine,['10.21037/apm-21-255'] 3143,33836878,Serotherapy-Free Regimen Improves Non-Relapse Mortality and Immune Recovery Among the Recipients of αβ TCell-Depleted Haploidentical Grafts: Retrospective Study in Childhood Leukemia.,"Depletion of αβ T cells from the graft prevents graft-versus-host disease (GVHD) and improves the outcome of hematopoietic stem cell transplantation (HSCT) from haploidentical donors. Delayed recovery of adaptive immunity remains a problem, which can be approached by adoptive T-cell transfer. In a randomized trial, we have assessed the safety and efficacy of low-dose memory (CD45RA-depleted) donor lymphocytes (mDLI) after HSCT with αβ T-cell depletion. Antithymocyte globulin (ATG) is viewed as an essential component of preparative regimen, critical for both prevention of graft failure and GVHD. Variable pharmacokinetics of ATG may significantly affect lymphocyte subpopulations after HSCT. To uncover the potential of mDLI, we replaced rabbit ATG with tocilizumab and abatacept. Here we compare post hoc the immune recovery and the key clinical outcomes, including nonrelapse mortality (NRM), overall- and event-free survival (OS and EFS), between the cohort enrolled in the prospective randomized trial and a historical cohort, comprised of patients grafted with a conventional ATG-based HSCT with αβ T cell depletion. A cohort of 149 children was enrolled in the prospective trial and 108 patients were selected as historical controls from a prospectively populated database. Patient population was comprised of children with high-risk hematologic malignancies, with more than 90% represented by acute leukemia. Median age at enrollment was 8.8 years. In the prospective cohort 91% of the donors were haploidentical parents, whereas in the historical cohort 72% of the donors were haploidentical. Conditioning was based on either 12Gy total body irradiation or treosulfan. Thiotepa, fludarabine, bortezomib, and rituximab were used as additional agents. Patients in the historical cohort received rabbit ATG at 5 mg/kg total dose, while prospective cohort patients received tocilizumab at 8 mg /kg on day -1 and abatacept at 10 mg/kg on days 0, 7, 14, and 28. Patients in the prospective trial cohort were randomized 1:1 to receive mDLI starting on day 0, whereas 69% of historical cohort patients received mDLI after engraftment, as part of previous trials. Primary engraftment rate was 99% in the prospective cohort and 98% in the historical cohort. The incidence of grade II-IV aGVHD was 13% in the prospective cohort and 16 % in the control group. Chronic GVHD developed among 13% (historical) and 7% (prospective) cohorts (P = .07). The incidence of cytomegalovirus viremia was 51% in the prospective cohort arm and 54% in the historical control arm (p = ns). Overall, in the prospective cohort 2-year NRM was 2%, incidence of relapse was 25%, EFS was 71%, and OS was 80%, whereas in the historical cohort 2-year NRM was 13%, incidence of relapse was 19%, EFS was 67%, and OS was 76%, difference non-significant for relapse and survival. NRM was significantly improved in the ATG-free cohort (P = .002). Recovery of both αβ- and γδ- T cells was significantly improved at days +30 and +60 after HSCT in recipients of ATG-free preparative regimens, as well as recovery of naïve T cells. Among the recipients of αβ T-cell-depleted grafts, replacement of ATG with nonlymphodepleting abatacept and tocilizumab immunomodulation did not compromise engraftment and GVHD control and was associated with significantly lower NRM and better immune recovery early after HSCT.",2021,Chronic GVHD developed among 13% (historical) and 7% (prospective) cohorts (P = .07).,"['149 children was enrolled in the prospective trial and 108 patients were selected as historical controls from a prospectively populated database', 'Recipients of αβ TCell-Depleted Haploidentical Grafts: Retrospective Study in Childhood Leukemia', 'Patient population was comprised of children with high-risk hematologic malignancies, with more than 90% represented by acute leukemia']","['Serotherapy-Free Regimen', 'Antithymocyte globulin (ATG', 'mDLI starting', 'αβ- and γδ', 'conventional ATG-based HSCT with αβ T cell depletion', 'rabbit ATG', 'Thiotepa, fludarabine, bortezomib, and rituximab', '12Gy total body irradiation or treosulfan', 'tocilizumab', 'low-dose memory (CD45RA-depleted) donor lymphocytes (mDLI) after HSCT with αβ T-cell depletion']","['Chronic GVHD', 'incidence of relapse', 'recovery of naïve T cells', 'NRM', 'safety and efficacy', 'Depletion of αβ T cells', 'relapse and survival', 'Relapse Mortality and Immune Recovery', 'incidence of grade II-IV aGVHD', 'cytomegalovirus viremia', 'T cells', 'Primary engraftment rate', 'nonrelapse mortality (NRM), overall- and event-free survival (OS and EFS']","[{'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia'}]","[{'cui': 'C0242348', 'cui_str': 'Serotherapy'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0003442', 'cui_str': 'Lymphocyte Immune Globulin, Anti-Thymocyte Globulin'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0677960', 'cui_str': 'T-cell depletion'}, {'cui': 'C0359156', 'cui_str': 'Rabbit anti-human T-lymphocyte globulin'}, {'cui': 'C0039871', 'cui_str': 'Thiotepa'}, {'cui': 'C0059985', 'cui_str': 'fludarabine'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0043162', 'cui_str': 'Total body irradiation'}, {'cui': 'C0076959', 'cui_str': 'treosulfan'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0108789', 'cui_str': 'Lymphocyte antigen CD45RA'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}]","[{'cui': 'C0867389', 'cui_str': 'Chronic graft-versus-host disease'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease'}, {'cui': 'C0877635', 'cui_str': 'Cytomegalovirus viremia'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",149.0,0.0647175,Chronic GVHD developed among 13% (historical) and 7% (prospective) cohorts (P = .07).,"[{'ForeName': 'Larisa', 'Initials': 'L', 'LastName': 'Shelikhova', 'Affiliation': 'Department of Hematopoietic Stem Cell Transplantation, Dmitriy Rogachev National Medical Center Of Pediatric Hematology, Oncology And Immunology, Moscow, Russia.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Glushkova', 'Affiliation': 'Transplantation Immunology And Immunotherapy Laboratory, Dmitriy Rogachev National Medical Center Of Pediatric Hematology, Oncology And Immunology, Moscow, Russia.'}, {'ForeName': 'Ruslan', 'Initials': 'R', 'LastName': 'Nikolaev', 'Affiliation': 'Stem Cell Physiology Laboratory, Dmitriy Rogachev National Medical Center Of Pediatric Hematology, Oncology And Immunology, Moscow, Russia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Dunaikina', 'Affiliation': 'Department of Hematopoietic Stem Cell Transplantation, Dmitriy Rogachev National Medical Center Of Pediatric Hematology, Oncology And Immunology, Moscow, Russia.'}, {'ForeName': 'Zhanna', 'Initials': 'Z', 'LastName': 'Zhekhovtsova', 'Affiliation': 'Department of Hematopoietic Stem Cell Transplantation, Dmitriy Rogachev National Medical Center Of Pediatric Hematology, Oncology And Immunology, Moscow, Russia.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Blagov', 'Affiliation': 'Department of Hematopoietic Stem Cell Transplantation, Dmitriy Rogachev National Medical Center Of Pediatric Hematology, Oncology And Immunology, Moscow, Russia.'}, {'ForeName': 'Rimma', 'Initials': 'R', 'LastName': 'Khismatullina', 'Affiliation': 'Department of Hematopoietic Stem Cell Transplantation, Dmitriy Rogachev National Medical Center Of Pediatric Hematology, Oncology And Immunology, Moscow, Russia.'}, {'ForeName': 'Dmitriy', 'Initials': 'D', 'LastName': 'Balashov', 'Affiliation': 'Department of Hematopoietic Stem Cell Transplantation, Dmitriy Rogachev National Medical Center Of Pediatric Hematology, Oncology And Immunology, Moscow, Russia.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Kurnikova', 'Affiliation': 'Transfusion Medicine Service, Dmitriy Rogachev National Medical Center Of Pediatric Hematology, Oncology And Immunology, Moscow, Russia.'}, {'ForeName': 'Dmitriy', 'Initials': 'D', 'LastName': 'Pershin', 'Affiliation': 'Transplantation Immunology And Immunotherapy Laboratory, Dmitriy Rogachev National Medical Center Of Pediatric Hematology, Oncology And Immunology, Moscow, Russia.'}, {'ForeName': 'Yakov', 'Initials': 'Y', 'LastName': 'Muzalevskii', 'Affiliation': 'Transfusion Medicine Service, Dmitriy Rogachev National Medical Center Of Pediatric Hematology, Oncology And Immunology, Moscow, Russia.'}, {'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Kazachenok', 'Affiliation': 'Transfusion Medicine Service, Dmitriy Rogachev National Medical Center Of Pediatric Hematology, Oncology And Immunology, Moscow, Russia.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Osipova', 'Affiliation': 'Stem Cell Physiology Laboratory, Dmitriy Rogachev National Medical Center Of Pediatric Hematology, Oncology And Immunology, Moscow, Russia.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Trakhtman', 'Affiliation': 'Transfusion Medicine Service, Dmitriy Rogachev National Medical Center Of Pediatric Hematology, Oncology And Immunology, Moscow, Russia.'}, {'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Maschan', 'Affiliation': 'Department of Hematopoietic Stem Cell Transplantation, Dmitriy Rogachev National Medical Center Of Pediatric Hematology, Oncology And Immunology, Moscow, Russia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Maschan', 'Affiliation': 'Department of Hematopoietic Stem Cell Transplantation, Dmitriy Rogachev National Medical Center Of Pediatric Hematology, Oncology And Immunology, Moscow, Russia. Electronic address: mmaschan@yandex.ru.'}]",Transplantation and cellular therapy,['10.1016/j.jtct.2021.01.010'] 3144,33836161,"New regimens of benznidazole monotherapy and in combination with fosravuconazole for treatment of Chagas disease (BENDITA): a phase 2, double-blind, randomised trial.","BACKGROUND Current treatment for Chagas disease with the only available drugs, benznidazole or nifurtimox, has substantial limitations, including long treatment duration and safety and tolerability concerns. We aimed to evaluate the efficacy and safety of new benznidazole monotherapy regimens and combinations with fosravuconazole, in the treatment of Chagas disease. METHODS We did a double-blind, double-dummy, phase 2, multicentre, randomised trial in three outpatient units in Bolivia. Adults aged 18-50 years with chronic indeterminate Chagas disease, confirmed by serological testing and positive qualitative PCR results, were randomly assigned (1:1:1:1:1:1:1) to one of seven treatment groups using a balanced block randomisation scheme with an interactive response system. Participants were assigned to benznidazole 300 mg daily for 8 weeks, 4 weeks, or 2 weeks, benznidazole 150 mg daily for 4 weeks, benznidazole 150 mg daily for 4 weeks plus fosravuconazole, benznidazole 300 mg once per week for 8 weeks plus fosravuconazole, or placebo, with a 12-month follow-up period. The primary endpoints were sustained parasitological clearance at 6 months, defined as persistent negative qualitative PCR results from end of treatment, and incidence and severity of treatment-emergent adverse events, serious adverse events, and adverse events leading to treatment discontinuation. Primary efficacy analysis was based on the intention-to-treat and per-protocol populations and secondary efficacy analyses on the per-protocol population. Safety analyses were based on the as-treated population. Recruitment is now closed. This trial is registered with ClinicalTrials.gov, NCT03378661. FINDINGS Between Nov 30, 2016, and July 27, 2017, we screened 518 patients, and 210 were enrolled and randomised. 30 patients (14%) were assigned to each treatment group. All 210 randomised patients were included in the intention-to-treat population, and 190 (90%) were included in the per-protocol population. In the intention-to-treat analysis, only one (3%) of 30 patients in the placebo group had sustained parasitological clearance at 6 months of follow-up. Sustained parasitological clearance at 6 months was observed in 25 (89%) of 28 patients receiving benznidazole 300 mg daily for 8 weeks (rate difference vs placebo 86% [95% CI 73-99]), 25 (89%) of 28 receiving benznidazole 300 mg daily for 4 weeks (86% [73-99]), 24 (83%) of 29 receiving benznidazole 300 mg daily for 2 weeks (79% [64-95]), 25 (83%) of 30 receiving benznidazole 150 mg daily for 4 weeks (80% [65-95]), 23 (85%) of 28 receiving benznidazole 150 mg daily for 4 weeks plus fosravuconazole (82% [67-97]), and 24 (83%) of 29 receiving benznidazole 300 mg weekly for 8 weeks plus fosravuconazole (79% [64-95]; p<0·0001 for all group comparisons with placebo). Six patients (3%) had ten serious adverse events (leukopenia [n=3], neutropenia [n=2], pyrexia, maculopapular rash, acute cholecystitis, biliary polyp, and breast cancer), eight had 12 severe adverse events (defined as interfering substantially with the patient's usual functions; elevated alanine aminotransferase [n=4], elevated gamma-glutamyltransferase [n=2], elevated aspartate aminotransferase [n=1], neutropenia [n=3], leukopenia [n=1], and breast cancer [n=1]), and 15 (7%) had adverse events that led to treatment discontinuation (most of these were in the groups who received benznidazole 300 mg daily for 8 weeks, benznidazole 300 mg once per week for 8 weeks plus fosravuconazole, and benznidazole 150 mg daily for 4 weeks plus fosravuconazole). No adverse events leading to treatment discontinuation were observed in patients treated with benznidazole 300 mg daily for 2 weeks or placebo. There were no treatment-related deaths. INTERPRETATION Benznidazole induced effective antiparasitic response, regardless of treatment duration, dose, or combination with fosravuconazole, and was well tolerated in adult patients with chronic Chagas disease. Shorter or reduced regimens of benznidazole could substantially improve treatment tolerability and accessibility, but further studies are needed to confirm these results. FUNDING Drugs for Neglected Diseases initiative (DNDi). TRANSLATION For the Spanish translation of the abstract see Supplementary Materials section.",2021,"Sustained parasitological clearance at 6 months was observed in 25 (89%) of 28 patients receiving benznidazole 300 mg daily for 8 weeks (rate difference vs placebo 86% [95% CI 73-99]), 25 (89%) of 28 receiving benznidazole 300 mg daily for 4 weeks (86% [73-99]), 24 (83%) of 29 receiving benznidazole 300 mg daily for 2 weeks (79% [64-95]), 25 (83%) of 30 receiving benznidazole 150 mg daily for 4 weeks (80% [65-95]), 23 (85%) of 28 receiving benznidazole 150 mg daily for 4 weeks plus fosravuconazole (82% [67-97]), and 24 (83%) of 29 receiving benznidazole 300 mg weekly for 8 weeks plus fosravuconazole","['n=4], elevated gamma-glutamyltransferase [n=2], elevated aspartate aminotransferase [n=1], neutropenia [n=3], leukopenia [n=1], and breast cancer [n=1]), and 15 (7%) had adverse events that led to treatment discontinuation (most of these were in the groups who received', 'All 210 randomised patients were included in the intention-to-treat population, and 190 (90%) were included in the per-protocol population', 'adult patients with chronic Chagas disease', 'Between Nov 30, 2016, and July 27, 2017, we screened 518 patients, and 210 were enrolled and randomised', 'three outpatient units in Bolivia', '30 patients (14', 'Adults aged 18-50 years with chronic indeterminate Chagas disease, confirmed by serological testing and positive qualitative PCR results', 'Chagas disease']","['fosravuconazole', 'balanced block randomisation scheme with an interactive response system', 'benznidazole 150 mg daily for 4 weeks, benznidazole 150 mg daily for 4 weeks plus fosravuconazole, benznidazole 300 mg once per week for 8 weeks plus fosravuconazole, or placebo', 'benznidazole 300 mg daily for 8 weeks, benznidazole 300 mg once per week for 8 weeks plus fosravuconazole, and benznidazole 150 mg daily for 4 weeks plus fosravuconazole', 'placebo', 'benznidazole', 'benznidazole 300 mg weekly for 8 weeks plus fosravuconazole', 'benznidazole monotherapy and in combination with fosravuconazole', 'benznidazole 150 mg daily for 4 weeks plus fosravuconazole']","['serious adverse events (leukopenia [n=3], neutropenia [n=2], pyrexia, maculopapular rash, acute cholecystitis, biliary polyp, and breast cancer', 'efficacy and safety', 'alanine aminotransferase', 'Sustained parasitological clearance', 'sustained parasitological clearance', 'persistent negative qualitative PCR results from end of treatment, and incidence and severity of treatment-emergent adverse events, serious adverse events, and adverse events leading to treatment discontinuation', 'severe adverse events']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0343804', 'cui_str': ""Chronic Chagas' disease""}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0005918', 'cui_str': 'Bolivia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205258', 'cui_str': 'Indeterminate'}, {'cui': 'C0041234', 'cui_str': 'Infection by Trypanosoma cruzi'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205473', 'cui_str': 'Serologic'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0053230', 'cui_str': 'benznidazole'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0423791', 'cui_str': 'Maculopapular rash'}, {'cui': 'C0149520', 'cui_str': 'Acute cholecystitis'}, {'cui': 'C2363746', 'cui_str': 'Biliary polyp'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205468', 'cui_str': 'Parasitologic'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}]",,0.592577,"Sustained parasitological clearance at 6 months was observed in 25 (89%) of 28 patients receiving benznidazole 300 mg daily for 8 weeks (rate difference vs placebo 86% [95% CI 73-99]), 25 (89%) of 28 receiving benznidazole 300 mg daily for 4 weeks (86% [73-99]), 24 (83%) of 29 receiving benznidazole 300 mg daily for 2 weeks (79% [64-95]), 25 (83%) of 30 receiving benznidazole 150 mg daily for 4 weeks (80% [65-95]), 23 (85%) of 28 receiving benznidazole 150 mg daily for 4 weeks plus fosravuconazole (82% [67-97]), and 24 (83%) of 29 receiving benznidazole 300 mg weekly for 8 weeks plus fosravuconazole","[{'ForeName': 'Faustino', 'Initials': 'F', 'LastName': 'Torrico', 'Affiliation': 'Fundación Ciencia y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente (CEADES), Cochabamba, Bolivia; Universidad Mayor de San Simón, Cochabamba, Bolivia.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Gascón', 'Affiliation': 'Barcelona Institute for Global Health, Barcelona, Spain; Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Barreira', 'Affiliation': 'DNDi Latin America, Rio de Janeiro, Brazil.'}, {'ForeName': 'Bethania', 'Initials': 'B', 'LastName': 'Blum', 'Affiliation': 'DNDi Latin America, Rio de Janeiro, Brazil.'}, {'ForeName': 'Igor C', 'Initials': 'IC', 'LastName': 'Almeida', 'Affiliation': 'University of Texas at El Paso, El Paso, TX, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Alonso-Vega', 'Affiliation': 'Barcelona Institute for Global Health, Barcelona, Spain; DNDi Latin America, Rio de Janeiro, Brazil.'}, {'ForeName': 'Tayná', 'Initials': 'T', 'LastName': 'Barboza', 'Affiliation': 'DNDi Latin America, Rio de Janeiro, Brazil.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Bilbe', 'Affiliation': 'Drugs for Neglected Diseases initiative (DNDi), Geneva, Switzerland.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Correia', 'Affiliation': 'DNDi Latin America, Rio de Janeiro, Brazil.'}, {'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Garcia', 'Affiliation': 'Fundación Ciencia y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente (CEADES), Cochabamba, Bolivia.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Ortiz', 'Affiliation': 'Fundación Ciencia y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente (CEADES), Cochabamba, Bolivia; Juan Misael Saracho Autonomous University, Tarija, Bolivia.'}, {'ForeName': 'Rudy', 'Initials': 'R', 'LastName': 'Parrado', 'Affiliation': 'Universidad Mayor de San Simón, Cochabamba, Bolivia.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Ramirez', 'Affiliation': 'Instituto Nacional de Parasitología ""Dr Mario Fatala Chaben"" (INP-ANLIS), Buenos Aires, Argentina.'}, {'ForeName': 'Isabela', 'Initials': 'I', 'LastName': 'Ribeiro', 'Affiliation': 'Drugs for Neglected Diseases initiative (DNDi), Geneva, Switzerland.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Strub-Wourgaft', 'Affiliation': 'Drugs for Neglected Diseases initiative (DNDi), Geneva, Switzerland.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Vaillant', 'Affiliation': 'Luxembourg Institute of Health, Strassen, Luxembourg.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Sosa-Estani', 'Affiliation': 'DNDi Latin America, Rio de Janeiro, Brazil; Epidemiology and Public Health Research Centre, CONICET, Buenos Aires, Argentina. Electronic address: ssosa@dndi.org.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30844-6'] 3145,33835822,Impact of a Genomic Test on Treatment Decision in a Predominantly African American Population With Favorable-Risk Prostate Cancer: A Randomized Trial.,"PURPOSE The Genomic Prostate Score (GPS), performed on biopsy tissue, predicts adverse outcome in prostate cancer (PCa) and has shown promise for improving patient selection for active surveillance (AS). However, its impact on treatment choice in high-risk populations of African Americans is largely unknown and, in general, the effect of the GPS on this difficult decision has not been evaluated in randomized trials. METHODS Two hundred men with National Comprehensive Cancer Network very low to low-intermediate PCa from three Chicago hospitals (70% Black, 16% college graduates) were randomly assigned at diagnosis to standard counseling with or without a 12-gene GPS assay. The primary end point was treatment choice at a second postdiagnosis visit. The proportion of patients choosing AS was compared, and multivariable modeling was used to estimate the effects of various factors on AS acceptance. RESULTS AS acceptance was high overall, although marginally lower in the intervention group (77% v 88%; P = .067), and lower still when men with inadequate specimens were excluded ( P = .029). Men with lower health literacy who received a GPS were seven-fold less likely to choose AS compared with controls, whereas no difference was seen in men with higher health literacy ( P interaction = .022). Among men with low-intermediate risk, 69% had GPS values consistent with unfavorable intermediate or high-risk cancer. AS choice was also independently associated with a family history of PCa and having health insurance. CONCLUSION In contrast to other studies, the net effect of the GPS was to move patients away from AS, primarily among men with low health literacy. These findings have implications for our understanding of how prognostic molecular assays that generate probabilities of poor outcome can affect treatment decisions in diverse clinical populations.",2021,"AS acceptance was high overall, although marginally lower in the intervention group (77% v 88%; P = .067), and lower still when men with inadequate specimens were excluded ( P = .029).","['prostate cancer (PCa', 'men with low health literacy', 'Predominantly African American Population With Favorable-Risk Prostate Cancer', 'African Americans', 'men with low-intermediate risk, 69% had GPS values consistent with unfavorable intermediate or high-risk cancer', 'Two hundred men with National Comprehensive Cancer Network very low to low-intermediate PCa from three Chicago hospitals (70% Black, 16% college graduates']","['Genomic Test', 'standard counseling with or without a 12-gene GPS assay', 'GPS']",[],"[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}]","[{'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}]",[],200.0,0.140929,"AS acceptance was high overall, although marginally lower in the intervention group (77% v 88%; P = .067), and lower still when men with inadequate specimens were excluded ( P = .029).","[{'ForeName': 'Adam B', 'Initials': 'AB', 'LastName': 'Murphy', 'Affiliation': 'Department of Urology, Northwestern University, Chicago, IL.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Abern', 'Affiliation': 'Department of Urology, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Division of Epidemiology and Biostatistics, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Heidy', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Division of Epidemiology and Biostatistics, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Courtney M P', 'Initials': 'CMP', 'LastName': 'Hollowell', 'Affiliation': 'Division of Urology, Cook County Health and Hospital System, Chicago, IL.'}, {'ForeName': 'Roohollah', 'Initials': 'R', 'LastName': 'Sharifi', 'Affiliation': 'Department of Urology, Jesse Brown VA Medical Center, Chicago, IL.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Vidal', 'Affiliation': 'Division of Urology, Cook County Health and Hospital System, Chicago, IL.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Kajdacsy-Balla', 'Affiliation': 'Department of Pathology, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Marin', 'Initials': 'M', 'LastName': 'Sekosan', 'Affiliation': 'Department of Pathology, Cook County Health and Hospital System, Chicago, IL.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Ferrer', 'Affiliation': 'Department of Pathology, Cook County Health and Hospital System, Chicago, IL.'}, {'ForeName': 'Shoujin', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Pathology and Laboratory Services, Jesse Brown VA Medical Center, Chicago, IL.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Gallegos', 'Affiliation': 'Pathology and Laboratory Services, Jesse Brown VA Medical Center, Chicago, IL.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'King-Lee', 'Affiliation': 'Department of Pathology, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Lisa K', 'Initials': 'LK', 'LastName': 'Sharp', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Carol E', 'Initials': 'CE', 'LastName': 'Ferrans', 'Affiliation': 'Department of Biobehavioral Nursing Science, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Gann', 'Affiliation': 'Department of Pathology, University of Illinois at Chicago, Chicago, IL.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.02997'] 3146,33833978,Polyethylene Glycol Plus Electrolytes with Stimulant Laxative in Paediatric Faecal Disimpaction: A Randomised Controlled Study.,"Functional constipation is common in the paediatric population all over the world. Effective disimpaction to evacuate the impacted faecal matter forms an essential initial step in the management of constipation. Though different regimens of polyethylene glycol 3350 with electrolytes (PEG+E) are accepted as the prime medication for disimpaction, response is not always satisfactory. A randomised prospective study was undertaken, in a tertiary paediatric Gastroenterology centre to find out the outcome of a 2-day disimpaction when a stimulant laxative sodium picosulphate was added to PEG3350+E (PEG+E+PS group) and comparing it with the outcome using PEG3350+E (PEG+E group) alone. Hundred and one children were randomised into two groups to receive PEG+E+PS and PEG+E. Results revealed that PEG+E+PS group proved significantly superior to PEG+E group in most of the efficacy-parameters in terms of disimpaction as well as long-term management of constipation. Though stimulant laxatives are being used for disimpaction, comparative data are lacking. This was the 1st such comparative study looking at the efficacy of these two processes of disimpaction along with long term effect on treatment.",2021,Hundred and one children were randomised into two groups to receive PEG+E+PS and PEG+E. Results revealed that PEG+E+PS group proved significantly superior to PEG+E group in most of the efficacy-parameters in terms of disimpaction as well as long-term management of constipation.,"['Paediatric Faecal Disimpaction', 'Hundred and one children']","['PEG+E+PS', 'PEG3350+E (PEG+E+PS', 'PEG+E', 'PEG3350+E (PEG+E group) alone', 'Polyethylene Glycol Plus Electrolytes with Stimulant Laxative', 'PEG+E+PS and PEG+E', 'polyethylene glycol 3350 with electrolytes (PEG+E']",['Functional constipation'],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1328368', 'cui_str': 'Faecal disimpaction'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0724672', 'cui_str': 'POLYETHYLENE GLYCOL 3350'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}, {'cui': 'C0282090', 'cui_str': 'Laxative'}]","[{'cui': 'C0401146', 'cui_str': 'Constipation - functional'}]",1.0,0.00932544,Hundred and one children were randomised into two groups to receive PEG+E+PS and PEG+E. Results revealed that PEG+E+PS group proved significantly superior to PEG+E group in most of the efficacy-parameters in terms of disimpaction as well as long-term management of constipation.,"[{'ForeName': 'Bhaswati C', 'Initials': 'BC', 'LastName': 'Acharyya', 'Affiliation': 'Division of Paediatric Gastroenterology, AMRI Hospitals, Kolkata, India.'}, {'ForeName': 'Chandrayee', 'Initials': 'C', 'LastName': 'Bhattacharyya', 'Affiliation': 'Division of Paediatrics, Apollo Gleneagles Hospital, Kolkata, India.'}, {'ForeName': 'Meghdeep', 'Initials': 'M', 'LastName': 'Mukhopadhyay', 'Affiliation': 'Division of Paediatrics, AMRI Hospitals, Kolkata, India.'}, {'ForeName': 'Saumyabrata', 'Initials': 'S', 'LastName': 'Acharyya', 'Affiliation': 'Division of Paediatrics, AMRI Hospitals, Kolkata, India.'}]","Pediatric gastroenterology, hepatology & nutrition",['10.5223/pghn.2021.24.2.230'] 3147,33837986,Effects of motor imagery training on lower limb motor function of patients with chronic stroke: A pilot single-blind randomized controlled trial.,"AIMS This pilot study aimed to evaluate the effects of motor imagery training on lower limb motor function of stroke patients. BACKGROUND Motor imagery training has played an important role in rehabilitation outcomes of stroke patients. METHODS In this pilot randomized controlled trial 32 stroke patients were randomly divided into experimental and control groups from January to June 2017. Patients in both groups received conventional neuro-rehabilitation five times a week in 3-h segments for 6 weeks. Patients in the experimental group underwent an additional 20 min of motor imagery training. Measures were evaluated by motor function of the lower extremity, activities of daily living and balance ability. RESULTS The outcomes significantly improved by motor imagery training were the Fugl-Meyer Assessment of the lower extremity, the Functional Independence Measure dealing with transfers and locomotion, and the Berg Balance Scale. CONCLUSION Motor imagery training could be used as a complement to physical rehabilitation of stroke patients. Our findings may be helpful to develop nursing strategies aimed at improving functional ability of stroke patients and thus enhancing their quality of life. SUMMARY STATEMENT What is already known about this topic? Lower extremity dyskinesia is among the most common complications that significantly limit the patient's activities of daily living. Motor imagery training, a safe and cost-efficient technique, may be used as a complement to physical rehabilitation of stroke patients. Evidence suggests that motor imagery training is effective in upper limb recovery after stroke. There is limited evidence of the effectiveness of motor imagery training on lower limb motor functions of patients with chronic stroke. What this paper adds? Motor imagery training can be incorporated into conventional therapy among individuals by rehabilitation specialist nurses with sufficient experience of motor imagery training, but substantial resources are needed. Six-week motor imagery training resulted in a significant improvement in the motor performance of lower limbs in patients with stroke. Further study is needed to modify and optimize the present programme and should be focused on enabling more stroke patients to benefit from motor imagery training. The implications of this paper: The addition of motor imagery training to the conventional neuro-rehabilitation can significantly promote the recovery of motor performance of lower limbs in stroke patients, thus reducing long-term disability and associated socio-economic burden. The findings of this pilot study may be helpful to develop nursing strategies aimed at improving functional ability and consequently the quality of life of stroke patients. Nurses can learn the motor imagery training as a technique for practising psychomotor nursing skills.",2021,"The outcomes significantly improved by motor imagery training were the Fugl-Meyer Assessment of the lower extremity, the Functional Independence Measure dealing with transfers and locomotion, and the Berg Balance Scale. CONCLUSION ","['patients with stroke', '32 stroke patients', 'stroke patients', 'patients with chronic stroke', 'individuals by rehabilitation specialist nurses with sufficient experience of motor imagery training', 'practising psychomotor nursing skills']","['Motor imagery training', 'conventional neuro-rehabilitation', 'additional 20\u2009min of motor imagery training', 'motor imagery training', 'Six-week motor imagery training']","['motor performance of lower limbs', 'limb motor function', 'Fugl-Meyer Assessment of the lower extremity, the Functional Independence Measure dealing with transfers and locomotion, and the Berg Balance Scale.\nCONCLUSION', 'Lower extremity dyskinesia', 'motor imagery training', 'motor function of the lower extremity, activities of daily living and balance ability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0023946', 'cui_str': 'Locomotor Activity'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}]",,0.0069901,"The outcomes significantly improved by motor imagery training were the Fugl-Meyer Assessment of the lower extremity, the Functional Independence Measure dealing with transfers and locomotion, and the Berg Balance Scale. CONCLUSION ","[{'ForeName': 'Xiao-Jun', 'Initials': 'XJ', 'LastName': 'Yin', 'Affiliation': ""Department of Neurology, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, China.""}, {'ForeName': 'Yuan-Jiao', 'Initials': 'YJ', 'LastName': 'Wang', 'Affiliation': ""Department of Rehabilitation Medicine, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, China.""}, {'ForeName': 'Xiao-Di', 'Initials': 'XD', 'LastName': 'Ding', 'Affiliation': ""Department of Neurology, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, China.""}, {'ForeName': 'Tian-Ming', 'Initials': 'TM', 'LastName': 'Shi', 'Affiliation': ""Department of Neurology, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, China.""}]",International journal of nursing practice,['10.1111/ijn.12933'] 3148,33837916,Home sleep apnea testing: an accuracy study.,"AIM There are no studies comparing tests performed at home with those carried out in the laboratory, using the same device. The only studies that have been performed have compared the device used at home with the standard polygraph used in the laboratory. The purpose of this study was therefore to verify the accuracy of the home diagnosis of obstructive sleep apnea syndrome (OSAS) via unassisted type 2 portable polysomnography, compared with polysomnography using the same equipment in a sleep laboratory. METHODS To avoid any possible order effect on the apnea-hypopnea index (AHI), we randomly created two groups of 20-total 40 patients, according to the test sequence. One of the groups had the first test at home and the second test in the laboratory (H-L); the other group had the first test in the laboratory and the second at home (L-H). The second test always took place on the night immediately following the first test. All polysomnographic monitoring was undertaken with the same equipment, an Embletta X100 system (Embla, Natus Inc., Middleton, USA). The Embletta X100 is a portable polygraph that records eleven polygraph signs: (1) electroencephalogram C4/A; (2) electroencephalogram O2/M1; (3) submental EMG; (4) electrooculogram of the right side; (5) nasal cannula (air flow); (6) respiratory effort against a plethysmographic chest strap; (7) respiratory effort against an abdominal plethysmographic belt; (8) heart rate; (9) saturation of oxyhemoglobin; (10) snoring; and (11) body position. RESULTS There was no difference in sleep efficiency between the group monitored in the laboratory and the group tested at home (p = 0.30). There was no difference in total sleep time (p = 0.11) or sleep latency (p = 0.52), or in the latency in phases N2 and N3 between the monitoring in the laboratory and at home (N2 p = 0.24; N3 p = 0.09). Some differences occurred regarding the PSG that took place at home, with longer duration of wake after sleep onset (WASO) and longer latency for REM sleep, due to failure of the patient to start the monitoring by pressing the ""events"" button on the device. In the distribution of sleep phases, there was no difference between the group monitored in the laboratory and the group tested at home. CONCLUSION Results from home sleep monitoring correlate well with the laboratory ""gold standard"" and may be an option for diagnosing OSAS in selected patients.",2021,"There was no difference in total sleep time (p = 0.11) or sleep latency (p = 0.52), or in the latency in phases N2 and N3 between the monitoring in the laboratory and at home (N2 p = 0.24; N3 p = 0.09).",[],['electroencephalogram O2/M1; (3) submental EMG; (4) electrooculogram of the right side; (5) nasal cannula (air flow); (6) respiratory effort against a plethysmographic chest strap; (7) respiratory effort against an abdominal plethysmographic belt; (8) heart rate; (9) saturation of oxyhemoglobin; (10) snoring; and (11) body position'],"['sleep latency', 'longer duration of wake after sleep onset (WASO) and longer latency for REM sleep', 'total sleep time', 'obstructive sleep apnea syndrome (OSAS', 'Home sleep apnea testing', 'apnea-hypopnea index (AHI', 'sleep efficiency']",[],"[{'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0013854', 'cui_str': 'Electro-oculogram examination'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0425466', 'cui_str': 'Respiratory effort'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0183631', 'cui_str': 'Strap'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0452227', 'cui_str': 'Belt'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0030069', 'cui_str': 'Oxyhemoglobin'}, {'cui': 'C0037384', 'cui_str': 'Snoring'}, {'cui': 'C1262869', 'cui_str': 'Body position'}]","[{'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0037322', 'cui_str': 'Rapid eye movement sleep'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",40.0,0.0123034,"There was no difference in total sleep time (p = 0.11) or sleep latency (p = 0.52), or in the latency in phases N2 and N3 between the monitoring in the laboratory and at home (N2 p = 0.24; N3 p = 0.09).","[{'ForeName': 'Edilson', 'Initials': 'E', 'LastName': 'Zancanella', 'Affiliation': 'Neuro-Sono Sleep Center, Neurology Department, Unifesp, São Paulo, Brazil.'}, {'ForeName': 'Lucila Fernandes', 'Initials': 'LF', 'LastName': 'do Prado', 'Affiliation': 'Neuro-Sono Sleep Center, Neurology Department, Unifesp, São Paulo, Brazil.'}, {'ForeName': 'Luciane Bizari', 'Initials': 'LB', 'LastName': 'de Carvalho', 'Affiliation': 'Neuro-Sono Sleep Center, Neurology Department, Unifesp, São Paulo, Brazil.'}, {'ForeName': 'Almiro J', 'Initials': 'AJ', 'LastName': 'Machado Júnior', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, University of Campinas (UNICAMP), Campinas, São Paulo, Brazil. almiromachadophd@gmail.com.'}, {'ForeName': 'Agrício Nubiato', 'Initials': 'AN', 'LastName': 'Crespo', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, University of Campinas (UNICAMP), Campinas, São Paulo, Brazil.'}, {'ForeName': 'Gilmar Fernandes', 'Initials': 'GF', 'LastName': 'do Prado', 'Affiliation': 'Neuro-Sono Sleep Center, Neurology Department, Unifesp, São Paulo, Brazil.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-021-02372-6'] 3149,33837906,A randomized clinical trial evaluating the immunomodulatory effect of convalescent plasma on COVID-19-related cytokine storm.,"Evaluating the effect of convalescent plasma (CP) on some cytokine storm indices in severe COVID-19 patients. Totally, 62 patients were randomly assigned into two groups for this clinical trial. Patients in the intervention group received one unit (500 mL) plasma on the admission day plus standard drugs while the controls merely received standard treatments. Eventually, primary and secondary outcomes were evaluated. In the CP group, compared with controls, the mean levels of lymphocytes and IL-10 significantly increased while the levels of IL-6, TNF-α, and IFN-γ decreased (p < 0.05). The length of in-hospital stay, and mortality rate did not significantly reduce in the CP group compared with controls (p > 0.05) while WHO severity scores remarkably improved (p = 0.01), despite the higher frequency of underlying diseases among the CP group (66.7%) vs. controls (33.3%). Although CP has a remarkable immunomodulatory and antiviral potential to improve the cytokine storm and disease severity in COVID-19 patients, it did not considerably affect the mortality rate.",2021,"In the CP group, compared with controls, the mean levels of lymphocytes and IL-10 significantly increased while the levels of IL-6, TNF-α, and IFN-γ decreased (p < 0.05).","['severe COVID-19 patients', '62 patients']","['CP', 'one unit (500\xa0mL) plasma on the admission day plus standard drugs while the controls merely received standard treatments', 'convalescent plasma (CP']","['levels of IL-6, TNF-α, and IFN-γ', 'mean levels of lymphocytes and IL-10', 'COVID-19-related cytokine storm', 'WHO severity scores', 'length of in-hospital stay, and mortality rate', 'mortality rate', 'frequency of underlying diseases']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0919747', 'cui_str': 'Cytokine storm'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",62.0,0.0516912,"In the CP group, compared with controls, the mean levels of lymphocytes and IL-10 significantly increased while the levels of IL-6, TNF-α, and IFN-γ decreased (p < 0.05).","[{'ForeName': 'Mandana', 'Initials': 'M', 'LastName': 'Pouladzadeh', 'Affiliation': 'Emergency Medicine Department, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Safdarian', 'Affiliation': 'Nanotechnology Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. msafdaryan@gmail.com.'}, {'ForeName': 'Peyman', 'Initials': 'P', 'LastName': 'Eshghi', 'Affiliation': 'Pediatric Congenital Hematologic Disorders Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Abolghasemi', 'Affiliation': 'Applied Microbiology Research Center, Systems Biology and Poisonings Institute, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza Ghorbani', 'Initials': 'AG', 'LastName': 'Bavani', 'Affiliation': 'Radiology Department, Abadan University of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Sheibani', 'Affiliation': 'Infectious Diseases Department, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Parastoo', 'Initials': 'P', 'LastName': 'Moradi Choghakabodi', 'Affiliation': 'Thalassemia and Hemoglobinopathy Research Center, Health Research Institute, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. parastoomoradi40@yahoo.com.'}, {'ForeName': 'Abdolaziz', 'Initials': 'A', 'LastName': 'Feghhi', 'Affiliation': 'Blood Transfusion Organization, Ahvaz, Khuzestan, Iran.'}, {'ForeName': 'Mehri', 'Initials': 'M', 'LastName': 'Ghafourian Boroujerdnia', 'Affiliation': 'Department of Immunology, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Forouzan', 'Affiliation': 'Department of Emergency Medicine, Imam Khomeini General Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Jalali Far', 'Affiliation': 'Thalassemia and Hemoglobinopathy Research Center, Health Research Institute, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Gholam Abbas', 'Initials': 'GA', 'LastName': 'Kaydani', 'Affiliation': 'Department of Laboratory Sciences, Allied Health Sciences School, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Rajaei', 'Affiliation': 'Department of Internal Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mansour', 'Initials': 'M', 'LastName': 'Amin', 'Affiliation': 'Department of Microbiology, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Torabizadeh', 'Affiliation': 'Golestan Hospital Clinical Research Development Unit, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Yousefi', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Health Research Institute, Ahvaz, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Hadaddezfuli', 'Affiliation': 'Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",Internal and emergency medicine,['10.1007/s11739-021-02734-8'] 3150,33837890,"Long-term Impacts and Benefit-Cost Analysis of the Communities That Care Prevention System at Age 23, 12 Years After Baseline.","This study estimated sustained impacts and long-term benefits and costs of the Communities That Care (CTC) prevention system, implemented and evaluated in a longitudinal cluster-randomized trial involving 24 communities in seven states. Analyses utilized reports from a longitudinal panel of 4407 participants, followed since the study's baseline in grade 5, with most recent follow-up 12 years later at age 23. Impacts on lifetime abstinence from primary outcomes of substance use and antisocial behavior were estimated using generalized linear mixed Poisson regression analysis, adjusted for individual and community-level covariates. Possible cascading effects on 4-year college completion, major depressive disorder, and generalized anxiety disorder through age 23 were evaluated as secondary outcomes. CTC had a statistically significant global effect on primary outcomes and also on combined primary and secondary outcomes. Among primary outcomes, point estimates suggested absolute improvements in lifetime abstinence of 3.5 to 6.1% in the intervention arm and relative improvements of 13 to 55%; 95% confidence intervals revealed some uncertainty in estimates. Among secondary outcomes, 4-year college completion was 1.9% greater among young adults from intervention communities, a 20% relative improvement. Mental health outcomes were approximately the same across trial arms. Although CTC had small sustained effects through age 23, benefit-cost analyses indicated CTC was reliably cost beneficial, with a net present value of $7152 (95% credible interval: $1253 to $15,268) per participant from primary impacts and $17,919 ($306 to $39,186) when secondary impacts were also included. It remained cost beneficial even when impacts were adjusted downward due to the involvement of CTC's developer in the trial. Findings suggest that broader dissemination of CTC could improve public health and individual lives in the long term and generate positive net benefits to society.",2021,"Among secondary outcomes, 4-year college completion was 1.9% greater among young adults from intervention communities, a 20% relative improvement.","[""4407 participants, followed since the study's baseline in grade 5, with most recent follow-up 12\xa0years later at age 23"", '24 communities in seven states', '12\xa0Years']",['CTC'],"['Mental health outcomes', 'lifetime abstinence', '4-year college completion', 'public health and individual lives', '4-year college completion, major depressive disorder, and generalized anxiety disorder']","[{'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1705232', 'cui_str': 'Common terminology criteria for adverse events grade 5'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}]",24.0,0.202006,"Among secondary outcomes, 4-year college completion was 1.9% greater among young adults from intervention communities, a 20% relative improvement.","[{'ForeName': 'Margaret R', 'Initials': 'MR', 'LastName': 'Kuklinski', 'Affiliation': 'Social Development Research Group, School of Social Work, University of Washington, 9725 Third Avenue NE, Suite 401, Seattle, WA, 98115 , USA. mrk63@uw.edu.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Oesterle', 'Affiliation': 'Southwest Interdisciplinary Research Center, School of Social Work, Arizona State University, 201 N Central Ave, 33rd floor, Phoenix, AZ, 85004, USA.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Briney', 'Affiliation': 'Social Development Research Group, School of Social Work, University of Washington, 9725 Third Avenue NE, Suite 401, Seattle, WA, 98115 , USA.'}, {'ForeName': 'J David', 'Initials': 'JD', 'LastName': 'Hawkins', 'Affiliation': 'Social Development Research Group, School of Social Work, University of Washington, 9725 Third Avenue NE, Suite 401, Seattle, WA, 98115 , USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-021-01218-7'] 3151,33837797,Microablative radiofrequency versus pelvic floor muscle training for stress urinary incontinence: a randomized controlled trial.,"INTRODUCTION AND HYPOTHESIS The efficacy of radiofrequency (RF) in stress urinary incontinence (SUI) is as yet unknown. The aim was to compare the effect of fractional microablative RF and pelvic floor muscle training (PFMT) against the combination of both therapies (RF + PFMT) in the SUI and on genitourinary syndrome (GSM). METHODS This was a three-arm randomized clinical trial including 117 climacteric women with SUI. In group 1 the treatment consisted of three monthly sessions of RF; in group 2 it was 12 weekly PFMT sessions; in group 3 it was RF + PFMT simultaneously. Assessments at baseline and 30 days after the end of therapy were conducted using validated questionnaires and scales for urinary, vaginal, and sexual functions and cytology for vaginal trophy. RESULTS Urinary scores improved significantly in all three groups post-treatment (p < 0.001) with a higher improvement in the RF + PFMT group (p = 0.002). One-hour pad test results were equal in the three groups. Vaginal symptoms showed an incremental improvement in RF (p < 0.007), and vaginal laxity showed a similar improvement in the three groups (p = 0.323). Vaginal Health Index score was more significant in RF and RF + PFMT groups. Sexual function improved in RF and PFMT. CONCLUSIONS The association between RF and PFMT showed significant improvement in the SUI symptoms assessed by questionnaire. The vaginal symptoms and dryness showed greater improvement in the RF treatment and vaginal laxity showed similar improvement in the three groups. The combination of RF and PFMT in sexual function did not show benefits superior to those achieved by the therapies alone.",2021,The vaginal symptoms and dryness showed greater improvement in the RF treatment and vaginal laxity showed similar improvement in the three groups.,"['117 climacteric women with SUI', 'stress urinary incontinence', 'stress urinary incontinence (SUI']","['RF and PFMT', 'fractional microablative RF and pelvic floor muscle training (PFMT', 'Microablative radiofrequency versus pelvic floor muscle training', 'RF', 'radiofrequency (RF']","['SUI symptoms', 'vaginal laxity', 'RF treatment and vaginal laxity', 'Vaginal symptoms', 'vaginal symptoms and dryness', 'validated questionnaires and scales for urinary, vaginal, and sexual functions and cytology for vaginal trophy', 'Urinary scores', 'RF', 'Vaginal Health Index score', 'Sexual function']","[{'cui': 'C0008943', 'cui_str': 'Change of Life'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}]","[{'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}]","[{'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0332536', 'cui_str': 'Laxity'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0010818', 'cui_str': 'Cytology'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",117.0,0.0385059,The vaginal symptoms and dryness showed greater improvement in the RF treatment and vaginal laxity showed similar improvement in the three groups.,"[{'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Slongo', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Campinas Faculty of Medical Sciences, Campinas, SP, Brazil.'}, {'ForeName': 'Ana Lygia B', 'Initials': 'ALB', 'LastName': 'Lunardi', 'Affiliation': 'Department of Surgery, University of Campinas Faculty of Medical Sciences, Campinas, SP, Brazil.'}, {'ForeName': 'Cássio L Z', 'Initials': 'CLZ', 'LastName': 'Riccetto', 'Affiliation': 'Department of Surgery, University of Campinas Faculty of Medical Sciences, Campinas, SP, Brazil.'}, {'ForeName': 'Helymar C', 'Initials': 'HC', 'LastName': 'Machado', 'Affiliation': 'Statistics Department, University of Campinas Faculty of Medical Sciences, Campinas, SP, Brazil.'}, {'ForeName': 'Cássia R T', 'Initials': 'CRT', 'LastName': 'Juliato', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Campinas Faculty of Medical Sciences, Campinas, SP, Brazil. cassia.raquel@gmail.com.'}]",International urogynecology journal,['10.1007/s00192-021-04758-2'] 3152,33837787,Efficacy of tailored recommendations to promote healthy lifestyles: a post hoc analysis of a randomized controlled trial.,"Prevention is the key to stopping the ravages of cardiovascular diseases, the main cause of death worldwide. The objective was to analyze the efficacy of tailored recommendations to promote healthy lifestyles. Parallel-arm randomized controlled trial with 1 year follow-up. Individuals aged 35-74 years from Girona (Spain) randomly selected from a population with no cardiovascular diseases at baseline were included. Participants in the intervention group received a brochure with tailored healthy choices according to the individual risk profile and a trained nurse explained all recommendations in detail in a 30 min consultation. One year changes in smoking, Mediterranean diet adherence, physical activity, and weight were analyzed with McNemar, Student's t, Wilcoxon, and Fisher exact tests according to an intention-to-treat strategy. Of 955 individuals (52.3% women; mean age 50 [±10] years) randomly allocated to the intervention or control group, one participant in each group presented a cardiovascular event and 768 (81%) were reexamined at 1 year follow-up. The prevalence of nonsmokers increased in both the intervention and control groups (78.1%-82.5%, p = <.001, and 76.7% to 78.8%, p = .015, respectively); however, significance persisted only in the intervention group when stratified by sex, age group, and educational level. Adherence to a Mediterranean diet increased in the intervention group (22.3%-26.5%, p = .048). In conclusion, a brief personalized intervention with science-based recommendations according to individual risk profiles appears to improve healthy lifestyles, particularly nonsmoking and adherence to a Mediterranean diet. This promising intervention system offers evidence-based recommendations to develop healthy lifestyles.",2021,"Adherence to a Mediterranean diet increased in the intervention group (22.3%-26.5%, p = .048).","['955 individuals (52.3% women; mean age 50 [±10] years', 'healthy lifestyles', 'Individuals aged 35-74 years from Girona (Spain) randomly selected from a population with no cardiovascular diseases at baseline were included']",['brochure with tailored healthy choices according to the individual risk profile and a trained nurse explained all recommendations in detail in a 30 min consultation'],"['Adherence to a Mediterranean diet', 'smoking, Mediterranean diet adherence, physical activity, and weight', 'prevalence of nonsmokers']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}]",,0.0275599,"Adherence to a Mediterranean diet increased in the intervention group (22.3%-26.5%, p = .048).","[{'ForeName': 'María', 'Initials': 'M', 'LastName': 'Barroso', 'Affiliation': 'Cardiovascular Epidemiology and Genetics Research Group, IMIM-Hospital del Mar Research Institute, 08003 Barcelona, Spain.'}, {'ForeName': 'M Dolors', 'Initials': 'MD', 'LastName': 'Zomeño', 'Affiliation': 'Cardiovascular Risk and Nutrition, IMIM-Hospital del Mar Medical Research Institute, 08003 Barcelona, Spain.'}, {'ForeName': 'Jorge L', 'Initials': 'JL', 'LastName': 'Díaz', 'Affiliation': 'Cardiovascular Epidemiology and Genetics Research Group, IMIM-Hospital del Mar Research Institute, 08003 Barcelona, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Pérez', 'Affiliation': 'Regicor Research Group, IMIM-Hospital del Mar Medical Research Institute, 08003 Barcelona, Spain.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Martí-Lluch', 'Affiliation': ""Unitat de Suport a la Recerca de Girona, Institut Universitari d'Investigació en Atenció Primària Jordi Gol, 17002 Girona, Spain.""}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Cordón', 'Affiliation': ""Centre d'Atenció Primària Montilivi, Direcció d'Atenció Primària Girona, Institut Català de la Salut, 17003 Girona, Spain.""}, {'ForeName': 'Rafel', 'Initials': 'R', 'LastName': 'Ramos', 'Affiliation': ""Unitat de Suport a la Recerca de Girona, Institut Universitari d'Investigació en Atenció Primària Jordi Gol, 17002 Girona, Spain.""}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Cabezas', 'Affiliation': 'Catalan Agency of Public Health, 08005 Barcelona, Spain.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Salvador', 'Affiliation': 'Catalan Agency of Public Health, 08005 Barcelona, Spain.'}, {'ForeName': 'Conxa', 'Initials': 'C', 'LastName': 'Castell', 'Affiliation': 'Catalan Agency of Public Health, 08005 Barcelona, Spain.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Schröder', 'Affiliation': 'Cardiovascular Risk and Nutrition, IMIM-Hospital del Mar Medical Research Institute, 08003 Barcelona, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Grau', 'Affiliation': 'Cardiovascular Epidemiology and Genetics Research Group, IMIM-Hospital del Mar Research Institute, 08003 Barcelona, Spain.'}]",Translational behavioral medicine,['10.1093/tbm/ibab035'] 3153,33837574,"Safety, tolerability, pharmacokinetics, pharmacodynamics, bioavailability and food effect of single doses of soticlestat in healthy subjects.","AIMS Soticlestat is a first-in-class selective inhibitor of cholesterol 24-hydroxylase, the enzyme that converts brain cholesterol to 24S-hydroxycholesterol (24HC), a positive allosteric modulator of N-methyl-D-aspartate receptors. Soticlestat is under development as treatment for rare developmental and epileptic encephalopathies. METHODS In this first-in-human study, 48 healthy men and women received single ascending doses of soticlestat oral solution or placebo. Subsequently, nine healthy subjects received soticlestat tablets under fed and fasting conditions to assess the relative oral bioavailability and effects of food. Serial blood and urine samples were collected for pharmacokinetic and pharmacodynamic assessments. RESULTS Soticlestat appeared to be well tolerated up to a single dose of 1350 mg. Adverse events (AEs) were mild in intensity, and dose-dependent increase in AE prevalence was not apparent. Soticlestat administered via oral solution was rapidly absorbed (median time to maximum plasma concentration [C max ] 0.250-0.520 h). Mean C max and area under plasma concentration-time curve from zero to infinity increased by 183- and 581-fold, respectively, over a 90-fold dose increase. Mean terminal elimination half-life was 0.820-7.16 h across doses. Renal excretion was negligible. Administration of soticlestat tablets, and with food, lowered C max but did not affect overall exposure. Plasma 24HC concentrations generally decreased with increasing dose. CONCLUSIONS Soticlestat appeared to be well tolerated after a single oral administration of up to 1350 mg and dose-dependently reduced plasma 24HC concentrations. Systemic exposure increased in a greater than dose-proportional manner over the dose range evaluated but was not affected by formulation or administration with food.",2021,Systemic exposure increased in a greater than dose-proportional manner over the dose range evaluated but was not affected by formulation or administration with food.,"['healthy subjects', '48 healthy men and women']","['soticlestat oral solution or placebo', 'soticlestat tablets']","['Mean terminal elimination half-life', 'Plasma 24HC concentrations', 'plasma 24HC concentrations', 'Mean C max and area under plasma concentration-time curve', 'Systemic exposure', 'Renal excretion', 'Serial blood and urine samples', 'Safety, tolerability, pharmacokinetics, pharmacodynamics, bioavailability and food effect', 'AE prevalence']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0991536', 'cui_str': 'Oral solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0208133', 'cui_str': '24-hydroxycholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1373187', 'cui_str': 'Renal Excretion'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",48.0,0.068789,Systemic exposure increased in a greater than dose-proportional manner over the dose range evaluated but was not affected by formulation or administration with food.,"[{'ForeName': 'Shining', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Quantitative Clinical Pharmacology, Takeda Pharmaceuticals International Co, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Quantitative Clinical Pharmacology, Takeda Pharmaceuticals International Co, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Merlo Pich', 'Affiliation': 'Clinical Science, Takeda Pharmaceuticals International AG, Zurich, Switzerland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Affinito', 'Affiliation': 'Patient Safety Evaluation, Takeda Pharmaceuticals.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cwik', 'Affiliation': 'Clinical Biomarker Innovation and Development, Takeda Pharmaceuticals, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Faessel', 'Affiliation': 'Quantitative Clinical Pharmacology, Takeda Pharmaceuticals International Co, Cambridge, Massachusetts, USA.'}]",British journal of clinical pharmacology,['10.1111/bcp.14854'] 3154,33837571,Effects of PMS50 supplementation on psychological symptoms of students with premenstrual syndrome.,"OBJECTIVE To evaluate the effects of PMS50 supplementation on psychological symptoms in students of AJUMS, Iran. METHODS This double-blind clinical trial was conducted at Ahvaz Jundishapur University of Medical Sciences, between December 2018 and March 2019. 50 female students with moderate to severe PMS randomly received either 550 mg/d of PMS50 or placebo (n=25), starting from one week before till the end of menstruation for three consecutive menstrual cycles. Anthropometric indices, dietary intake, physical activity level and severity of PMS were assessed at baseline and post-intervention. Data were analyzed by SPSS (version 22). Independent t-test was used to compare the results between groups. Paired t-test was used to compare the results within groups before and post study. RESULTS There was a significant improvement in psychological symptoms including depression, anger, feeling of hopelessness, desire to be alone, mood swings, irritability, anxiety and poor concentration observed in intervention group compared with control group post-intervention. Restlessness was significantly reduced in both groups post-intervention. The mean scores of low self-esteem, change in appetite and food cravings were decreased in both groups, but not significant between groups. CONCLUSION PMS50 supplementation may be effective in improvement of psychological symptoms in PMS.",2021,"The mean scores of low self-esteem, change in appetite and food cravings were decreased in both groups, but not significant between groups. ","['50 female students with moderate to severe PMS', 'students with premenstrual syndrome', 'Ahvaz Jundishapur University of Medical Sciences, between December 2018 and March 2019', 'students of AJUMS, Iran']","['PMS50 or placebo', 'PMS50 supplementation']","['mean scores of low self-esteem, change in appetite and food cravings', 'psychological symptoms including depression, anger, feeling of hopelessness, desire to be alone, mood swings, irritability, anxiety and poor concentration', 'Restlessness', 'Anthropometric indices, dietary intake, physical activity level and severity of PMS', 'psychological symptoms']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033046', 'cui_str': 'Premenstrual syndrome'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0679136', 'cui_str': 'Low self-esteem'}, {'cui': 'C0426587', 'cui_str': 'Altered appetite'}, {'cui': 'C0872380', 'cui_str': 'Food craving'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0150041', 'cui_str': 'Feeling hopeless'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0233417', 'cui_str': 'Poor concentration'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0033046', 'cui_str': 'Premenstrual syndrome'}]",,0.0386889,"The mean scores of low self-esteem, change in appetite and food cravings were decreased in both groups, but not significant between groups. ","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Sadeghi', 'Affiliation': 'Student Research Committee, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Zare Javid', 'Affiliation': 'Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Nazarinasab', 'Affiliation': 'Department of Psychiatry, Golestan Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hosein Haghighi-Zadeh', 'Affiliation': 'Department of Biostatistics, School of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13703'] 3155,33837539,Self-compassion training for certified nurse assistants in nursing homes.,"BACKGROUND/OBJECTIVES Certified nursing assistants (CNAs) who work in nursing homes (NHs) face significant work and personal stress. Self-compassion training has been shown to decrease stress postintervention in previous studies among healthcare providers and those in helping professions. This study examines the feasibility, acceptability, and preliminary outcomes of self-compassion training to address CNA stress and well-being. DESIGN Pre-post intervention. SETTING Three mid-size, nonprofit NHs in North Carolina. PARTICIPANTS Thirty CNAs, with a mean age of 49, 96% of whom were female, and 83% black/African American. INTERVENTION In one NH, participants received an 8-week, 2.5-h/session (20 h total) group intervention. At the time of recruitment for NHs 2 and 3, a briefer format (6-week, 1-h/session; 6 h total) became available and was preferred by CNAs, thus both NHs 2 and 3 participants received a 6-h group intervention. All interventions occurred in meeting rooms within participating NHs during shift changes. MEASUREMENTS Intervention attendance, retention, and acceptability; self-compassion, stress, burnout, depression, and attitudes toward residents with dementia, and job satisfaction pre-, post-, 3-month post-, and 6-month postintervention were assessed. RESULTS Attendance and program satisfaction were high, and attrition was low for both training formats. Self-compassion was significantly improved at all time periods (p < 0.001), and stress and depression improved significantly through 3 months (p < 0.05), but not 6 months. No statistically significant change in job satisfaction was noted. CONCLUSION Self-compassion interventions are feasible and acceptable for CNAs working in NHs and show promise for managing stress and improving well-being and compassion toward residents. The briefer 6-h format may maximize participation, while still providing benefits.",2021,"Self-compassion was significantly improved at all time periods (p < 0.001), and stress and depression improved significantly through 3 months (p < 0.05), but not 6 months.","['Thirty CNAs, with a mean age of 49, 96% of whom were female, and 83% black/African American', 'Three mid-size, nonprofit NHs in North Carolina', 'certified nurse assistants in nursing homes']","['Self-compassion interventions', 'self-compassion training', 'Self-compassion training']","['Intervention attendance, retention, and acceptability; self-compassion, stress, burnout, depression, and attitudes toward residents with dementia, and job satisfaction pre-, post-, 3-month post-, and 6-month postintervention', 'job satisfaction', 'stress and depression', 'Self-compassion']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0028663', 'cui_str': 'Nursing aid'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0029247', 'cui_str': 'Non-profit organization'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",,0.0196374,"Self-compassion was significantly improved at all time periods (p < 0.001), and stress and depression improved significantly through 3 months (p < 0.05), but not 6 months.","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Bluth', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lathren', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States.'}, {'ForeName': 'Johanna V T', 'Initials': 'JVT', 'LastName': 'Silbersack Hickey', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States.'}, {'ForeName': 'Sheryl', 'Initials': 'S', 'LastName': 'Zimmerman', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Wretman', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Sloane', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.17155'] 3156,33837518,Cost Effectiveness of Ceftolozane/Tazobactam Compared with Meropenem for the Treatment of Patients with Ventilated Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia.,"INTRODUCTION The clinical efficacy and safety of ceftolozane/tazobactam for the treatment of ventilated hospital-acquired bacterial pneumonia (vHABP) and ventilator-associated bacterial pneumonia (VABP) has been demonstrated in the phase III randomised controlled trial ASPECT-NP. However, there are no published data on the cost-effectiveness of ceftolozane/tazobactam for vHABP/VABP. These nosocomial infections are associated with high rates of morbidity and mortality, and are increasingly complicated by growing rates of resistance and the inappropriate use of antimicrobials. This study is to assess the cost-effectiveness of ceftolozane/tazobactam compared with meropenem for the treatment of vHABP/VABP in a US hospital setting. METHODS A short-term decision tree followed by a long-term Markov model was developed to estimate lifetime costs and quality-adjusted life-years associated with ceftolozane/tazobactam and meropenem in the treatment of patients with vHABP/VABP. Pathogen susceptibility and clinical efficacy were informed by the Program to Assess Ceftolozane/Tazobactam Susceptibility (PACTS) database and ASPECT-NP, respectively. A US healthcare sector perspective was adopted, capturing direct costs borne by third-party payers or integrated health systems, and direct health effects for patients. RESULTS In the confirmed treatment setting (post-susceptibility results), the incremental cost-effectiveness ratio for ceftolozane/tazobactam compared to meropenem was US$12,126 per quality-adjusted life-year (QALY); this reduced when used in the early treatment setting (before susceptibility results) at $4775/QALY. CONCLUSION Ceftolozane/tazobactam represents a highly cost-effective treatment option for patients with vHABP/VABP versus meropenem when used in either the confirmed or early treatment setting; with increased cost-effectiveness shown in the early setting.",2021,The clinical efficacy and safety of ceftolozane/tazobactam for the treatment of ventilated hospital-acquired bacterial pneumonia (vHABP) and ventilator-associated bacterial pneumonia (VABP) has been demonstrated in the phase III randomised controlled trial ASPECT-NP.,"['patients with vHABP/VABP versus', 'Patients with Ventilated Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia', 'patients with vHABP/VABP', 'ventilated hospital-acquired bacterial pneumonia (vHABP) and ventilator-associated bacterial pneumonia (VABP']","['ceftolozane/tazobactam', 'ceftolozane/tazobactam and meropenem', 'Ceftolozane/Tazobactam', 'meropenem', 'Meropenem', 'Ceftolozane/tazobactam']","['Pathogen susceptibility and clinical efficacy', 'incremental cost-effectiveness ratio', 'lifetime costs and quality-adjusted life-years', 'cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4727976', 'cui_str': 'Ventilated HABP'}, {'cui': 'C2189270', 'cui_str': 'VABP'}]","[{'cui': 'C3656593', 'cui_str': 'Ceftolozane and tazobactam'}, {'cui': 'C0066005', 'cui_str': 'meropenem'}]","[{'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",,0.0298158,The clinical efficacy and safety of ceftolozane/tazobactam for the treatment of ventilated hospital-acquired bacterial pneumonia (vHABP) and ventilator-associated bacterial pneumonia (VABP) has been demonstrated in the phase III randomised controlled trial ASPECT-NP.,"[{'ForeName': 'Jaesh', 'Initials': 'J', 'LastName': 'Naik', 'Affiliation': 'BresMed Health Solutions Ltd, Sheffield, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Puzniak', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Critchlow', 'Affiliation': 'BresMed Health Solutions Ltd, Sheffield, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Elsea', 'Affiliation': 'BresMed America Inc., Las Vegas, NV, USA.'}, {'ForeName': 'Ryan James', 'Initials': 'RJ', 'LastName': 'Dillon', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA. joe.yang@merck.com.'}]",Infectious diseases and therapy,['10.1007/s40121-021-00436-4'] 3157,33837509,Clinical effects of assessing electronic patient-reported outcomes monitoring symptomatic toxicities during breast cancer therapy: a nationwide and population-based study.,"The involvement of cancer patients in symptom reporting talks into our cultural narrative of empowerment and participation in decisions in health of both patients and professionals. Electronic patient-reported outcome (ePRO) is a tool applied for use in such interaction. Based on limited evidence and few empirical studies, health systems are rapidly implementing this instrument in managing patients in active treatment and in follow-up. In a cluster randomized trial of all Danish oncology departments treating breast cancer with adjuvant chemotherapy, we applied ePRO in 347 patients consecutively recruited. Our primary outcome, which was at least one treatment adjustment, was not significantly influenced using ePRO, 34% in the ePRO arm and 41% in the usual care arm received at least one treatment adjustment, p = 0.095. Number of hospitalizations and events of febrile neutropenia were not influenced by the intervention. We believe that one of the main reasons for this finding could be the application of PRO in a well-regulated treatment setting within a public health care system where the most impacting symptomatic toxicities are already taken care off.Trial registration: Clinicaltrials.gov identifier: NCT02996201, registered 19 Dec 2016, retrospectively registered.",2021,Number of hospitalizations and events of febrile neutropenia were not influenced by the intervention.,['347 patients consecutively recruited'],"['adjuvant chemotherapy', 'breast cancer therapy']",['Number of hospitalizations and events of febrile neutropenia'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}]",,0.225847,Number of hospitalizations and events of febrile neutropenia were not influenced by the intervention.,"[{'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Pappot', 'Affiliation': 'Documentation and Quality, Danish Cancer Society, Strandboulevarden 49, DK 2100, Copenhagen, Denmark. helle.pappot@regionh.dk.'}, {'ForeName': 'Christina W', 'Initials': 'CW', 'LastName': 'Baeksted', 'Affiliation': 'Documentation and Quality, Danish Cancer Society, Strandboulevarden 49, DK 2100, Copenhagen, Denmark.'}, {'ForeName': 'Aase', 'Initials': 'A', 'LastName': 'Nissen', 'Affiliation': 'Documentation and Quality, Danish Cancer Society, Strandboulevarden 49, DK 2100, Copenhagen, Denmark.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Knoop', 'Affiliation': 'Department of Oncology, Rigshospitalet, Blegdamsvej 9, DK 2100, Copenhagen, Denmark.'}, {'ForeName': 'Sandra A', 'Initials': 'SA', 'LastName': 'Mitchell', 'Affiliation': 'Outcomes Research Branch, Division of Cancer Control and Population Sciences, National Cancer Institute, 9609 Medical Center Drive, 3 East Suite 448, Rockville, MD, 20850, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Christensen', 'Affiliation': 'Documentation and Quality, Danish Cancer Society, Strandboulevarden 49, DK 2100, Copenhagen, Denmark.'}, {'ForeName': 'Niels Henrik', 'Initials': 'NH', 'LastName': 'Hjollund', 'Affiliation': 'Department of Clinical Epidemiology, Aarhus University Hospital, Olof Palmes Allé 43-45, 8200, Aarhus, Denmark.'}, {'ForeName': 'Christoffer', 'Initials': 'C', 'LastName': 'Johansen', 'Affiliation': 'Department of Oncology, Rigshospitalet, Blegdamsvej 9, DK 2100, Copenhagen, Denmark.'}]","Breast cancer (Tokyo, Japan)",['10.1007/s12282-021-01244-x'] 3158,33837482,Treatment of Chronic Aplastic Anemia with Chinese Patent Medicine Pai-Neng-Da Capsule () for Replacing Androgen Partially: A Clinical Multi-Center Study.,"OBJECTIVE To evaluate the efficacy and safety of Pai-Neng-Da Capsule (, panaxadiol saponins component, PNDC) in combination with the cyclosporine and androgen for patients with chronic aplastic anemia (CAA). METHODS A total of 79 CAA patients was randomly divided into 2 groups by a random number table, including PCA group [43 cases, orally PNDC 320 mg/d plus cyclosporine 5 mg/(kg·d) plus andriol 80 mg/d] and CA group [36 cases, orally cyclosporine 5 mg/(kg·d) plus andriol 160 mg/d]. All patients were treated and followed-up for 6 treatment courses over 24 weeks. The complete blood counts, score of Chinese medical (CM) symptoms were assessed and urine routine, electrocardiogram, hepatic and renal function were observed for safety evaluation. Female masculinization rating scale was established according to the actual clinical manifestations to evaluate the accurate degree of masculinization in female CAA patients treated by andriol. RESULTS The effective rates were 88.1% (37/42) in the PCA group and 77.8% (28/36) in the CA group based on the standard for the therapeutic efficacy evaluation of hematopathy. There was no significant difference in the white blood cell (WBC) counts, platelet counts and hemoglobin concentration of peripheral blood between two groups after 6 months treatment. The masculinization score of female patient in the PCA group was significantly lower than the CA group (P<0.05). The mild abdominal distention was observed in 1 cases in the PCA group. In CA group, the abnormalities in the hepatic function developed in 2 cases and the renal disfunction was found in 1 case. CONCLUSION The PNDC possesses certain curative effects in the treatment of CAA without obvious side-effects and can partially replace andriol thereby to reduce the degree of masculinization [Registried at Chinese Clinical Trial Registry (ChicTR1900028153)].",2021,"There was no significant difference in the white blood cell (WBC) counts, platelet counts and hemoglobin concentration of peripheral blood between two groups after 6 months treatment.","['patients with chronic aplastic anemia (CAA', '79 CAA patients', 'female CAA patients treated by andriol']","['CA', 'Pai-Neng-Da Capsule (, panaxadiol saponins component, PNDC', 'cyclosporine and androgen', 'Chinese Patent Medicine Pai-Neng-Da Capsule () for Replacing Androgen', 'PCA group [43 cases, orally PNDC 320 mg/d plus cyclosporine 5 mg/(kg·d) plus andriol 80 mg/d] and CA group [36 cases, orally cyclosporine 5 mg/(kg·d) plus andriol 160 mg/d']","['hepatic function', 'masculinization score of female patient', 'mild abdominal distention', 'Female masculinization rating scale', 'urine routine, electrocardiogram, hepatic and renal function', 'effective rates', 'complete blood counts, score of Chinese medical (CM) symptoms', 'renal disfunction', 'white blood cell (WBC) counts, platelet counts and hemoglobin concentration of peripheral blood']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0002874', 'cui_str': 'Aplastic anemia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0592050', 'cui_str': 'Restandol'}]","[{'cui': 'C4310131', 'cui_str': 'pai-neng-da'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0069999', 'cui_str': 'panaxadiol'}, {'cui': 'C0036189', 'cui_str': 'Saponins'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205710', 'cui_str': 'Progressive sclerosing poliodystrophy'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013231', 'cui_str': 'Drugs, Non-Prescription'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0030131', 'cui_str': 'p-Chloramphetamine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0592050', 'cui_str': 'Restandol'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0042755', 'cui_str': 'Virilization'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009555', 'cui_str': 'Complete blood count'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}]",79.0,0.0126628,"There was no significant difference in the white blood cell (WBC) counts, platelet counts and hemoglobin concentration of peripheral blood between two groups after 6 months treatment.","[{'ForeName': 'Zhi-Yong', 'Initials': 'ZY', 'LastName': 'Jiang', 'Affiliation': ""Department of Hematology, Jinhua People's Hospital, Jinhua, Zhejiang Province, 321000, China.""}, {'ForeName': 'Fang-Quan', 'Initials': 'FQ', 'LastName': 'Yu', 'Affiliation': ""Department of Hematology, Jinhua People's Hospital, Jinhua, Zhejiang Province, 321000, China.""}, {'ForeName': 'Rui-Lan', 'Initials': 'RL', 'LastName': 'Gao', 'Affiliation': 'Institute of Hematology Research, the First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, 310006, China. gaoruilan@126.com.'}, {'ForeName': 'Yue-Min', 'Initials': 'YM', 'LastName': 'Kuang', 'Affiliation': ""Department of Hematology, Jinhua People's Hospital, Jinhua, Zhejiang Province, 321000, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': ""Department of Hematology, Jinhua People's Hospital, Jinhua, Zhejiang Province, 321000, China.""}, {'ForeName': 'Yue-Hua', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology, the Second of Shaoxing Hospital, Shaoxing, Zhejiang Province, 312000, China.'}, {'ForeName': 'Lin-Jie', 'Initials': 'LJ', 'LastName': 'Li', 'Affiliation': 'Department of Hematology, Lishui Central Hospital, Lishui, Zhejiang Province, 323000, China.'}, {'ForeName': 'Gui-Fang', 'Initials': 'GF', 'LastName': 'Ouyang', 'Affiliation': 'Department of Hematology, First Hospital of Ningbo, Ningbo, Zhejiang Province, 315010, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Clinical Medicine, Medical College, Jinhua Polytechnic, Jinhua, Zhejiang Province, 321000, China.'}, {'ForeName': 'Xiao-Long', 'Initials': 'XL', 'LastName': 'Wu', 'Affiliation': 'Institute of Hematology Research, the First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, 310006, China.'}]",Chinese journal of integrative medicine,['10.1007/s11655-021-3283-z'] 3159,33837481,Effectiveness and Safety of Moxibustion Robots on Primary Dysmenorrhea: A Randomized Controlled Pilot Trial.,"OBJECTIVE To conduct a pilot trial to explore the effectiveness and safety of moxibustion robots in treating primary dysmenorrhea (PD) and evaluate its feasibility in clinic. METHODS A total of 70 participants with PD were allocated to either moxibustion robot (MR) group (35 cases) or manual moxibustion (MM) group (35 cases) using computer-generated randomization. One acupoint Guanyuan (CV 4) was selected to receive moxa heat stimulation. Two groups of participants were given 3 menstrual cycles of MM and MR treatment respectively (once a day, 5 days a session) and received another 3 menstrual cycles follow-up. The degree of pain was evaluated by short-form McGill pain questionnaire (SF-MPQ) and the symptoms of dysmenorrhea were evaluated by Cox Menstrual Symptom Scale (CMSS). The safety was measured by the occurrence rate of adverse events (AEs), including burns (blisters, red and swollen), itching, bowel changes, menstrual cycle disorder, menorrhagia and fatigue, etc. RESULTS: A total of 62 patients completed the trial, 32 in MR group and 30 in MM group. Compared with baseline, scores of SF-MPQ and CMSS significantly decreased in both groups (P<0.05), and no significant difference was observed between the two groups in the 3rd and 6th menstrual cycles (P>0.05). The total occurrence rate of AEs in MR group was 2.1%, which was significantly lower than MM group (7.2%, P<0.05). CONCLUSIONS MR has the same effect as MM at SF-MPQ and CMSS in patients with PD. However, MR is safer than MM (Trial registration No. ChiCTR1800018236).",2021,"Compared with baseline, scores of SF-MPQ and CMSS significantly decreased in both groups (P<0.05), and no significant difference was observed between the two groups in the 3rd and 6th menstrual cycles (P>0.05).","['Primary Dysmenorrhea', '62 patients completed the trial, 32 in MR group and 30 in MM group', 'patients with PD', '70 participants with PD']","['moxibustion robots', 'moxibustion robot (MR) group (35 cases) or manual moxibustion (MM', 'Moxibustion Robots']","['Cox Menstrual Symptom Scale (CMSS', 'McGill pain questionnaire (SF-MPQ) and the symptoms of dysmenorrhea', 'occurrence rate of adverse events (AEs), including burns (blisters, red and swollen), itching, bowel changes, menstrual cycle disorder, menorrhagia and fatigue, etc', 'total occurrence rate of AEs', 'degree of pain', 'scores of SF-MPQ and CMSS']","[{'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}]","[{'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}]","[{'cui': 'C0033551', 'cui_str': 'Prostaglandin synthase'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0457972', 'cui_str': 'Short form McGill pain questionnaire'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0005758', 'cui_str': 'Blister'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0025345', 'cui_str': 'Disorder of menstruation'}, {'cui': 'C0025323', 'cui_str': 'Menorrhagia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",70.0,0.0559548,"Compared with baseline, scores of SF-MPQ and CMSS significantly decreased in both groups (P<0.05), and no significant difference was observed between the two groups in the 3rd and 6th menstrual cycles (P>0.05).","[{'ForeName': 'Han-Rui', 'Initials': 'HR', 'LastName': 'Zhang', 'Affiliation': 'School of Acupuncture Moxibustion and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China.'}, {'ForeName': 'Hai-Yan', 'Initials': 'HY', 'LastName': 'Tu', 'Affiliation': 'College of Electrical Engineering, Sichuan University, Chengdu, 610065, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Rehabilitation, Chengdu Fifth People's Hospital, Chengdu, 611130, China.""}, {'ForeName': 'Shi-Lin', 'Initials': 'SL', 'LastName': 'Xia', 'Affiliation': 'College of Electrical Engineering, Sichuan University, Chengdu, 610065, China.'}, {'ForeName': 'Guo-You', 'Initials': 'GY', 'LastName': 'Zhao', 'Affiliation': 'College of Electrical Engineering, Sichuan University, Chengdu, 610065, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': 'School of Acupuncture Moxibustion and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China.'}, {'ForeName': 'Ying-Kun', 'Initials': 'YK', 'LastName': 'Li', 'Affiliation': 'Department of Acupuncture and Rehabilitation, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China. 975470100@qq.com.'}]",Chinese journal of integrative medicine,['10.1007/s11655-021-3287-8'] 3160,33828171,Distinguishing chronic low back pain in young adults with mild to moderate pain and disability using trunk compliance.,"Chronic low back pain (cLBP) rates among younger individuals are rising. Although pain and disability are often less severe, underlying changes in trunk behavior may be responsible for recurrence. We examine the biomarker capacity of a simple Trunk Compliance Index (TCI) to distinguish individuals with and without cLBP. A random subset (n = 49) of the RELIEF RCT were matched to healthy controls for sex, age, height and weight. We measured TCI (as displacement/ weight-normalized perturbation force) using anthropometrically-matched, suddenly-applied pulling perturbations to the trunk segment, randomized across three planes of motion (antero-posterior, medio-lateral, and rotational). Mean differences between cLBP, sex and perturbation direction were assessed with repeated-measures analysis of variance. Discriminatory accuracy of TCI was assessed using Receiver Operator Characteristic (ROC) analysis. Baseline characteristics between groups were equivalent (x̅ [range]): sex (57% female / group), age (23.0 [18-45], 22.8 [18-45]), height, cm (173.0 [156.5-205], 171.3 [121.2-197], weight, kg (71.8 [44.5-116.6], 71.7 [46.8-117.5]) with cLBP associated with significantly lower TCI for 5 of 6 directions (range mean difference, - 5.35: - 1.49, range 95% CI [- 6.46: - 2.18 to - 4.35: - 0.30]. Classification via ROC showed that composite TCI had high discriminatory potential (area under curve [95% CI], 0.90 [0.84-0.96]), driven by TCI from antero-posterior perturbations (area under curve [95% CI], 0.99 [0.97-1.00]). Consistent reductions in TCI suggests global changes in trunk mechanics that may go undetected in classic clinical examination. Evaluation of TCI in younger adults with mild pain and disability may serve as a biomarker for chronicity, leading to improved preventative measures in cLBP.Trial Registration and Funding RELIEF is registered with clinicaltrials.gov (NCT01854892) and funded by the NIH National Center for Complementary & Integrative Health (R01AT006978).",2021,"Classification via ROC showed that composite TCI had high discriminatory potential (area under curve [95% CI], 0.90 [0.84-0.96]), driven by TCI from antero-posterior perturbations (area under curve [95% CI], 0.99 [0.97-1.00]).","['younger adults with mild pain and disability', 'young adults with mild to moderate pain and disability using trunk compliance', 'individuals with and without cLBP']","['RELIEF RCT', 'TCI']",['Chronic low back pain (cLBP) rates'],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0278138', 'cui_str': 'Mild pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0564405', 'cui_str': 'Feeling relief'}]","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]",,0.203995,"Classification via ROC showed that composite TCI had high discriminatory potential (area under curve [95% CI], 0.90 [0.84-0.96]), driven by TCI from antero-posterior perturbations (area under curve [95% CI], 0.99 [0.97-1.00]).","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Stamenkovic', 'Affiliation': 'Department of Physical Therapy, College of Health Professions, Virginia Commonwealth University, 900 East Leigh St, 4th Floor, Richmond, VA, 23298, USA. astamenkovic@vcu.edu.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Clark', 'Affiliation': 'Ohio Musculoskeletal and Neurological Institute (OMNI), Ohio University, Athens, USA.'}, {'ForeName': 'Peter E', 'Initials': 'PE', 'LastName': 'Pidcoe', 'Affiliation': 'Department of Physical Therapy, College of Health Professions, Virginia Commonwealth University, 900 East Leigh St, 4th Floor, Richmond, VA, 23298, USA.'}, {'ForeName': 'Susanne M', 'Initials': 'SM', 'LastName': 'van der Veen', 'Affiliation': 'Department of Physical Therapy, College of Health Professions, Virginia Commonwealth University, 900 East Leigh St, 4th Floor, Richmond, VA, 23298, USA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'France', 'Affiliation': 'Ohio Musculoskeletal and Neurological Institute (OMNI), Ohio University, Athens, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Russ', 'Affiliation': 'School of Physical Therapy & Rehabilitation Sciences, University of South Florida, Tampa, USA.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Kinser', 'Affiliation': 'School of Nursing, Virginia Commonwealth University, Richmond, USA.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Thomas', 'Affiliation': 'Department of Physical Therapy, College of Health Professions, Virginia Commonwealth University, 900 East Leigh St, 4th Floor, Richmond, VA, 23298, USA.'}]",Scientific reports,['10.1038/s41598-021-87138-6'] 3161,33827848,Prognostic model to identify and quantify risk factors for mortality among hospitalised patients with COVID-19 in the USA.,"OBJECTIVES To develop a prognostic model to identify and quantify risk factors for mortality among patients admitted to the hospital with COVID-19. DESIGN Retrospective cohort study. Patients were randomly assigned to either training (80%) or test (20%) sets. The training set was used to fit a multivariable logistic regression. Predictors were ranked using variable importance metrics. Models were assessed by C-indices, Brier scores and calibration plots in the test set. SETTING Optum de-identified COVID-19 Electronic Health Record dataset including over 700 hospitals and 7000 clinics in the USA. PARTICIPANTS 17 086 patients hospitalised with COVID-19 between 20 February 2020 and 5 June 2020. MAIN OUTCOME MEASURE All-cause mortality while hospitalised. RESULTS The full model that included information on demographics, comorbidities, laboratory results, and vital signs had good discrimination (C-index=0.87) and was well calibrated, with some overpredictions for the most at-risk patients. Results were similar on the training and test sets, suggesting that there was little overfitting. Age was the most important risk factor. The performance of models that included all demographics and comorbidities (C-index=0.79) was only slightly better than a model that only included age (C-index=0.76). Across the study period, predicted mortality was 1.3% for patients aged 18 years old, 8.9% for 55 years old and 28.7% for 85 years old. Predicted mortality across all ages declined over the study period from 22.4% by March to 14.0% by May. CONCLUSION Age was the most important predictor of all-cause mortality, although vital signs and laboratory results added considerable prognostic information, with oxygen saturation, temperature, respiratory rate, lactate dehydrogenase and white cell count being among the most important predictors. Demographic and comorbidity factors did not improve model performance appreciably. The full model had good discrimination and was reasonably well calibrated, suggesting that it may be useful for assessment of prognosis.",2021,"Predicted mortality across all ages declined over the study period from 22.4% by March to 14.0% by May. CONCLUSION Age was the most important predictor of all-cause mortality, although vital signs and laboratory results added considerable prognostic information, with oxygen saturation, temperature, respiratory rate, lactate dehydrogenase and white cell count being among the most important predictors.","['Optum', 'patients admitted to the hospital with COVID-19', 'hospitalised patients with COVID-19 in the USA', '17\u2009086 patients hospitalised with COVID-19 between 20 February 2020 and 5 June 2020', 'patients aged 18 years old, 8.9% for 55 years old and 28.7% for 85 years old', '700 hospitals and 7000 clinics in the USA']",[],"['Predicted mortality', 'oxygen saturation, temperature, respiratory rate, lactate dehydrogenase and white cell count']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C4708914', 'cui_str': '7000'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]",[],"[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",17086.0,0.02197,"Predicted mortality across all ages declined over the study period from 22.4% by March to 14.0% by May. CONCLUSION Age was the most important predictor of all-cause mortality, although vital signs and laboratory results added considerable prognostic information, with oxygen saturation, temperature, respiratory rate, lactate dehydrogenase and white cell count being among the most important predictors.","[{'ForeName': 'Devin', 'Initials': 'D', 'LastName': 'Incerti', 'Affiliation': 'Product Development, Genentech, South San Francisco, California, USA incerti.devin@gene.com.'}, {'ForeName': 'Shemra', 'Initials': 'S', 'LastName': 'Rizzo', 'Affiliation': 'Product Development, Genentech, South San Francisco, California, USA.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Product Development, Genentech, South San Francisco, California, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Lindsay', 'Affiliation': 'Product Development, Genentech, South San Francisco, California, USA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Yau', 'Affiliation': 'Product Development, Genentech, South San Francisco, California, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Keebler', 'Affiliation': 'Product Development, Genentech, South San Francisco, California, USA.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Chia', 'Affiliation': 'Product Development, Genentech, South San Francisco, California, USA.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Tsai', 'Affiliation': 'Product Development, Genentech, South San Francisco, California, USA.'}]",BMJ open,['10.1136/bmjopen-2020-047121'] 3162,33827496,"A home-based, post-discharge early intervention program promotes motor development and physical growth in the early preterm infants: a prospective, randomized controlled trial.","BACKGROUND The implementation of early intervention (EI) in medical settings is time-consuming and resource-intensive, which limits its extensive use. In 2018, the Chinese Eugenics Association developed a home-based, post-discharge EI program. This study aims at evaluating the impact of this EI program on neurodevelopment and physical growth of early preterm infants. METHODS This study was a prospective, partially blinded, randomized controlled trial (RCT), followed by an open phase. A total of 73 infants born at 28 + 0  ~ 31 + 6 weeks' gestation who were admitted to the Children's Hospital of Chongqing Medical University between December 1, 2019, and June 31, 2020, were enrolled. Another 33 infants were retrospectively recruited as the reference group. Thirty-seven infants randomized in the first early intervention, then standard care (EI-SC) group performed a 30-day EI during RCT period, while 36 infants allocated to SC-EI group were given EI in the following open phase. The test of infant motor performance (TIMP), development quotient (DQ), and anthropometric measures (length, weight, head circumference) were measured at the baseline (T0), termination of the RCT (T1), and termination of the open phase (T2). Repeated measures analysis was performed for comparison among groups. RESULTS From T0 to T1, both groups had significant improvements in all outcome measures (all p < 0.001). A 30-day EI program was more effective in improving TIMP than standard care (from 53.12 ± 8.79 to 83.50 ± 11.85 in EI-SC group vs from 50.52 ± 8.64 to 75.97 ± 13.44 in SC-EI group, F = 4.232, p = 0.044). EI-SC group also had greater improvements in length, weight, and head circumference than SC-EI group (all p < 0.05). From T0 to T2, there was no significant difference regarding the improvements in all outcomes between the groups (all p > 0.05). At the endpoint of T2, the EI-SC and SC-EI group had similar TIMP and anthropometric measures, but much higher than the reference group (all p < 0.05). CONCLUSIONS These findings demonstrated that a home-based, post-discharge EI program in this study was a practical approach to promote motor development and physical growth in early preterm infants. TRIAL REGISTRATION CHICTR, CTR1900028330, registered December 19, 2019, https:// http://www.chictr.org.cn/showproj.aspx?proj=45706.",2021,"From T0 to T1, both groups had significant improvements in all outcome measures (all p < 0.001).","[""73 infants born at 28 +\u20090 \u2009~\u200931 +\u20096 weeks' gestation who were admitted to the Children's Hospital of Chongqing Medical University between December 1, 2019, and June 31, 2020, were enrolled"", 'Another 33 infants were retrospectively recruited as the reference group', 'early preterm infants']","['EI program', 'standard care (EI-SC']","['TIMP and anthropometric measures', 'termination of the RCT (T1), and termination of the open phase (T2', 'length, weight, and head circumference', 'infant motor performance (TIMP), development quotient (DQ), and anthropometric measures (length, weight, head circumference']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0145988', 'cui_str': 'TIMP Proteins'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",73.0,0.0510526,"From T0 to T1, both groups had significant improvements in all outcome measures (all p < 0.001).","[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': ""Department of Neonatology, National Clinical Research Center for Child Health and Disorders; Ministry of Education Key Laboratory of Child Development and Disorders; Chongqing Key Laboratory of Pediatrics, Children's Hospital of Chongqing Medical University, Chongqing, China.""}, {'ForeName': 'Jianhui', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Neonatology, National Clinical Research Center for Child Health and Disorders; Ministry of Education Key Laboratory of Child Development and Disorders; Chongqing Key Laboratory of Pediatrics, Children's Hospital of Chongqing Medical University, Chongqing, China.""}, {'ForeName': 'Xianhong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Neonatology, National Clinical Research Center for Child Health and Disorders; Ministry of Education Key Laboratory of Child Development and Disorders; Chongqing Key Laboratory of Pediatrics, Children's Hospital of Chongqing Medical University, Chongqing, China.""}, {'ForeName': 'Ruiyun', 'Initials': 'R', 'LastName': 'He', 'Affiliation': ""Department of Neonatology, National Clinical Research Center for Child Health and Disorders; Ministry of Education Key Laboratory of Child Development and Disorders; Chongqing Key Laboratory of Pediatrics, Children's Hospital of Chongqing Medical University, Chongqing, China.""}, {'ForeName': 'Shasha', 'Initials': 'S', 'LastName': 'He', 'Affiliation': ""Department of Neonatology, National Clinical Research Center for Child Health and Disorders; Ministry of Education Key Laboratory of Child Development and Disorders; Chongqing Key Laboratory of Pediatrics, Children's Hospital of Chongqing Medical University, Chongqing, China.""}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': ""Department of Neonatology, National Clinical Research Center for Child Health and Disorders; Ministry of Education Key Laboratory of Child Development and Disorders; Chongqing Key Laboratory of Pediatrics, Children's Hospital of Chongqing Medical University, Chongqing, China.""}, {'ForeName': 'Yujie', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': ""Department of Neonatology, National Clinical Research Center for Child Health and Disorders; Ministry of Education Key Laboratory of Child Development and Disorders; Chongqing Key Laboratory of Pediatrics, Children's Hospital of Chongqing Medical University, Chongqing, China.""}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Tao', 'Affiliation': ""Department of Neonatology, National Clinical Research Center for Child Health and Disorders; Ministry of Education Key Laboratory of Child Development and Disorders; Chongqing Key Laboratory of Pediatrics, Children's Hospital of Chongqing Medical University, Chongqing, China.""}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': ""Department of Neonatology, National Clinical Research Center for Child Health and Disorders; Ministry of Education Key Laboratory of Child Development and Disorders; Chongqing Key Laboratory of Pediatrics, Children's Hospital of Chongqing Medical University, Chongqing, China.""}, {'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': ""Department of Neonatology, National Clinical Research Center for Child Health and Disorders; Ministry of Education Key Laboratory of Child Development and Disorders; Chongqing Key Laboratory of Pediatrics, Children's Hospital of Chongqing Medical University, Chongqing, China.""}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': ""Department of Neonatology, National Clinical Research Center for Child Health and Disorders; Ministry of Education Key Laboratory of Child Development and Disorders; Chongqing Key Laboratory of Pediatrics, Children's Hospital of Chongqing Medical University, Chongqing, China. hlj1116@163.com.""}]",BMC pediatrics,['10.1186/s12887-021-02627-x'] 3163,33827495,"ILC-OPI: impulsive lifestyle counselling versus cognitive behavioral therapy to improve retention of patients with opioid use disorders and externalizing behavior: study protocol for a multicenter, randomized, controlled, superiority trial.","BACKGROUND Substance use disorders show a high comorbidity with externalizing behavior difficulties, creating treatment challenges, including difficulties with compliance, a high risk of conflict, and a high rate of offending post-treatment. Compared with people with other substance use disorders those with opioid use disorders have the highest risk of criminal activity, but studies on the evidence base for psychosocial treatment in opioid agonist treatment (OAT) are scarce. The Impulsive Lifestyle Counselling (ILC) program may be associated with better retention and outcomes among difficult-to-treat patients with this comorbidity. METHODS The study is a multicenter, randomized, controlled, superiority clinical trial. Participants will be a total of 137 hard-to-treat individuals enrolled in opioid agonist treatment (OAT). Participants will be randomized to either a standard treatment (14 sessions of individual manual-based cognitive behavioral therapy and motivational interviewing (MOVE-I)) or six sessions of ILC followed by nine sessions of MOVE-I. All participants will receive personalized text reminders prior to each session and vouchers for attendance, as well as medication as needed. The primary outcome is retention in treatment. Secondary measures include severity of drug use and days of criminal offending for profit three and nine months post-randomization. A secondary aim is, through a case-control study, to investigate whether participants in the trial differ from patients receiving treatment as usual in municipalities where ILC and MOVE-I have not been implemented in OAT. This will be done by comparing number of offences leading to conviction 12 months post-randomization recorded in the national criminal justice register and number of emergency room contacts 12 months post-randomization recorded in the national hospital register. DISCUSSION This is the first randomized, controlled clinical trial in OAT to test the effectiveness of ILC against a standardized comparison with structural elements to increase the likelihood of exposure to the elements of treatment. Results obtained from this study may have important clinical, social, and economic implications for publicly funded treatment of opioid use disorder. TRIAL REGISTRATION ISRCTN, ISRCTN19554367 , registered on 04/09/2020.",2021,"The Impulsive Lifestyle Counselling (ILC) program may be associated with better retention and outcomes among difficult-to-treat patients with this comorbidity. ","['participants in the trial differ from patients receiving treatment as usual in municipalities where ILC and MOVE-I have not been implemented in OAT', 'patients with opioid use disorders and externalizing behavior', 'Participants will be a total of 137 hard-to-treat individuals enrolled in']","['opioid agonist treatment (OAT', 'ILC-OPI: impulsive lifestyle counselling versus cognitive behavioral therapy', 'standard treatment (14 sessions of individual manual-based cognitive behavioral therapy and motivational interviewing (MOVE-I)) or six sessions of ILC', 'ILC', 'Impulsive Lifestyle Counselling (ILC) program']",['severity of drug use and days of criminal offending for profit three and nine months post-randomization'],"[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0699726', 'cui_str': 'Offenders'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",137.0,0.127457,"The Impulsive Lifestyle Counselling (ILC) program may be associated with better retention and outcomes among difficult-to-treat patients with this comorbidity. ","[{'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Hesse', 'Affiliation': 'Centre for Alcohol and Drug Research, Bartholins Allé 10, 8000, Aarhus C, Denmark. mh.crf@psy.au.dk.'}, {'ForeName': 'Birgitte', 'Initials': 'B', 'LastName': 'Thylstrup', 'Affiliation': 'Centre for Alcohol and Drug Research, Bartholins Allé 10, 8000, Aarhus C, Denmark.'}, {'ForeName': 'Sidsel Helena', 'Initials': 'SH', 'LastName': 'Karsberg', 'Affiliation': 'Centre for Alcohol and Drug Research, Bartholins Allé 10, 8000, Aarhus C, Denmark.'}, {'ForeName': 'Michael Mulbjerg', 'Initials': 'MM', 'LastName': 'Pedersen', 'Affiliation': 'Centre for Alcohol and Drug Research, Bartholins Allé 10, 8000, Aarhus C, Denmark.'}, {'ForeName': 'Mads Uffe', 'Initials': 'MU', 'LastName': 'Pedersen', 'Affiliation': 'Centre for Alcohol and Drug Research, Bartholins Allé 10, 8000, Aarhus C, Denmark.'}]",BMC psychiatry,['10.1186/s12888-021-03182-6'] 3164,33827488,Self-produced audio-visual animation introduction alleviates preoperative anxiety in pediatric strabismus surgery: a randomized controlled study.,"BACKGROUND Hospital anxiety caused by strabismus surgery has an unpleasant and disturbing feeling for both children and their parents. This study aimed to determine the effect of viewing a self-produced audio-visual animation introduction on preoperative anxiety and emergence agitation of pediatric patients undergoing strabismus surgery. METHODS In this prospective randomized study, 1 hundred children scheduled for strabismus surgery with aged 3 ~ 6 years. The children were randomly divided into 2 groups (n = 50 for each), Group A: using a self-produced audio-visual animation introduction; Group C: controlled group without audio-visual animation introduction. Children's preoperative anxiety was determined by the modified Yale Preoperative Anxiety Scale (mYPAS) at different time points: the night before surgery(T1), at pre-anesthetic holding room(T2), and just before anesthesia induction(T3). The Spielberger State-Trait Anxiety Inventory (STAI) was used to record the anxiety of parents at T1,T2 and T3. The incidence and the degree of emergence agitation were recorded. RESULTS The mYPAS scores at T2 and T3 were higher than T1(p < 0.05) in both groups. The average score of mYPAS in Group A was significantly lower than in Group C at T2 and T3(p < 0.05). The STAI scores in Group A at T2 and T3 were significantly lower than in Group C(p < 0.05). The incidence of agitation in Group A was lower than that in Group C(p < 0.05). CONCLUSIONS Based on the findings, viewing a self-produced audio-visual animation can effectively alleviate the preoperative anxiety for both children and their parents in pediatric strabismus surgery, and it was effective for reducing emergence agitation as well. TRIAL REGISTRATION The trial was prospectively registered before patient enrollment at Chinese Clinical Trial Registry (Clinical Trial Number: ChiCTR1900025116 , Date: 08/12/2019).",2021,The mYPAS scores at T2 and T3 were higher than T1(p < 0.05) in both groups.,"['pediatric strabismus surgery', '1 hundred children scheduled for strabismus surgery with aged 3\u2009~\u20096\u2009years', 'pediatric patients undergoing strabismus surgery']","['self-produced audio-visual animation introduction; Group C: controlled group without audio-visual animation introduction', 'viewing a self-produced audio-visual animation introduction', 'Self-produced audio-visual animation introduction']","['STAI scores', 'average score of mYPAS', 'Spielberger State-Trait Anxiety Inventory (STAI', ""Children's preoperative anxiety"", 'preoperative anxiety', 'modified Yale Preoperative Anxiety Scale (mYPAS', 'incidence of agitation', 'mYPAS scores']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0197981', 'cui_str': 'Strabismus surgery'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0376650', 'cui_str': 'Animation'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449911', 'cui_str': 'View'}]","[{'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451497', 'cui_str': 'Spielberger state-trait anxiety inventory'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}]",0.0,0.0157826,The mYPAS scores at T2 and T3 were higher than T1(p < 0.05) in both groups.,"[{'ForeName': 'Yuexi', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'Department of Anesthesiology, Eye Hospital and School of Ophthalmology and Optometry, Wenzhou Medical University, Xueyuan Road #270, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Aifen', 'Initials': 'A', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, Eye Hospital and School of Ophthalmology and Optometry, Wenzhou Medical University, Xueyuan Road #270, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Wanna', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, Eye Hospital and School of Ophthalmology and Optometry, Wenzhou Medical University, Xueyuan Road #270, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Wenxin', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Eye Hospital and School of Ophthalmology and Optometry, Wenzhou Medical University, Xueyuan Road #270, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Lisha', 'Initials': 'L', 'LastName': 'Ye', 'Affiliation': 'Department of Anesthesiology, Eye Hospital and School of Ophthalmology and Optometry, Wenzhou Medical University, Xueyuan Road #270, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Xiaojiang', 'Initials': 'X', 'LastName': 'Kong', 'Affiliation': 'Wenzhou Medical University, Wenzhou Chashan Senior education park, Ouhai District, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Le', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Wenzhou Medical University, South Baixiang Town, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Zhousheng', 'Initials': 'Z', 'LastName': 'Jin', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Wenzhou Medical University, South Baixiang Town, Wenzhou, Zhejiang, China. jzs185190370@163.com.'}]",BMC ophthalmology,['10.1186/s12886-021-01922-6'] 3165,33827478,Do the patient education program and nurse-led telephone follow-up improve treatment adherence in hemodialysis patients? A randomized controlled trial.,"BACKGROUND End-Stage Renal Disease (ESRD) is the final and permanent stage of Chronic Kidney Disease (CKD). Hemodialysis (HD) is the most common treatment for CKD. To have desirable therapeutic outcomes, patients have to adhere to a specific therapeutic regimen that reduces the hospitalization rate and side-effects of HD. The present study aimed to determine the effects of the patient education program and nurse-led telephone follow-up on adherence to the treatment in hemodialysis patients. METHODS This is a randomized controlled trial in which a total of 66 patients were recruited using convenience sampling and then randomly assigned to two groups of control (n = 33) and intervention (n = 33). Data were collected using a demographic questionnaire, the laboratory results record sheet, and the End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ), which included four dimensions of HD attendance, medication use, fluid restrictions, and diet recommendations. The intervention group received a patient education program and nurse-led follow-up services through telephone communication and the Short Message Service (SMS) for 3 months. All participants filled in the questionnaire before and after the intervention. Data were analyzed using IBM SPSS Statistics for Windows, version 25 (IBM Corp., Armonk, N.Y., USA). RESULTS The results showed a significant difference in the mean scores of HD attendance, medication use, fluid restrictions, and diet recommendations between the two groups immediately, 1 month, and 3 months after the intervention (p < .001). The results also indicated a significant difference in the mean scores of four dimensions during the four-time points of measurement in the intervention group (P < 0.0005). Therefore, the level of treatment adherence in the intervention group was higher than in the control group. Moreover, there was a significant difference in the mean score of laboratory values between the two groups after the intervention, except for the level of serum sodium (P = 0.130). CONCLUSION Implementation of the patient education program and nurse-led follow-up can lead to better adherence to hemodialysis in four dimensions of HD attendance, medication use, fluid restrictions, and dietary recommendations in HD patients. TRIAL REGISTRATION IRCT registration number: IRCT20190127042512N1 ; Registration date: 2020-09-12; Registration timing: retrospectively registered: Last update: 2020-09-12.",2021,"The results showed a significant difference in the mean scores of HD attendance, medication use, fluid restrictions, and diet recommendations between the two groups immediately, 1 month, and 3 months after the intervention (p < .001).","['HD patients', 'hemodialysis patients', '66 patients were recruited using convenience sampling']","['patient education program and nurse-led telephone follow-up', 'patient education program and nurse-led follow-up services through telephone communication and the Short Message Service (SMS']","['level of treatment adherence', 'level of serum sodium', 'mean scores of HD attendance, medication use, fluid restrictions, and diet recommendations', 'mean score of laboratory values', 'hospitalization rate and side-effects of HD', 'IBM SPSS Statistics for Windows, version 25 (IBM Corp., Armonk, N.Y., USA']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}]","[{'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0204700', 'cui_str': 'Fluid restriction'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0238190', 'cui_str': 'Inclusion body myositis'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]",66.0,0.0161548,"The results showed a significant difference in the mean scores of HD attendance, medication use, fluid restrictions, and diet recommendations between the two groups immediately, 1 month, and 3 months after the intervention (p < .001).","[{'ForeName': 'Mansour', 'Initials': 'M', 'LastName': 'Arad', 'Affiliation': 'Department of Medical-Surgical Nursing, School of Nursing and Midwifery, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Rasoul', 'Initials': 'R', 'LastName': 'Goli', 'Affiliation': 'Department of Medical-Surgical Nursing, School of Nursing and Midwifery, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Parizad', 'Affiliation': 'Patient Safety Research Center, Clinical Research Institute, Nursing & Midwifery School, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Davoud', 'Initials': 'D', 'LastName': 'Vahabzadeh', 'Affiliation': 'Nutrition & Biochemistry Department, School of Medicine, Ilam University of Medical Sciences, Ilam, Iran. dvaha2003@yahoo.com.'}, {'ForeName': 'Rahim', 'Initials': 'R', 'LastName': 'Baghaei', 'Affiliation': 'Patient Safety Research Center, Clinical Research Institute, Nursing & Midwifery School, Urmia University of Medical Sciences, Urmia, Iran.'}]",BMC nephrology,['10.1186/s12882-021-02319-9'] 3166,33830377,"Psychometric properties of FACIT-Fatigue in systemic lupus erythematosus: a pooled analysis of three phase 3 randomised, double-blind, parallel-group controlled studies (BLISS-SC, BLISS-52, BLISS-76).","BACKGROUND Fatigue is a key symptom in patients with systemic lupus erythematosus (SLE), and regulatory bodies recommend its assessment in clinical trials of SLE therapies. METHODS This post hoc pooled analysis of the three BeLimumab In Subjects with Systemic lupus erythematosus (BLISS) Phase 3 randomised, double-blind, parallel-group controlled trials evaluated the measurement properties of the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue. Patients (N = 2520) completed the FACIT-Fatigue every 4 weeks from baseline until the end of each study period. Internal consistency, test-retest reliability, convergent validity, and ability to detect changes in SLE were evaluated for the FACIT-Fatigue. RESULTS The FACIT-Fatigue showed good internal consistency reliability (Cronbach's alpha > 0.90), very good test-retest reliability (0.76 ≤ intraclass correlation coefficient ≤ 0.92), and moderate-strong convergent validity (0.49 ≤ |r| ≤ 0.86) against scale and summary measure scores from the Short Form 36 Health Survey Version 2. Correlations between FACIT-Fatigue and British Isles Lupus Assessment Group (BILAG) General/Musculoskeletal scores (0.24 ≤ |r| ≤ 0.43) supported convergent validity. Correlations between FACIT-Fatigue and the Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) scores and SLE annualised flare rate were weak but in the expected direction (ranging from - 0.02 to - 0.25). Known-groups validity testing showed that the FACIT-Fatigue can significantly discriminate between patient groups with differing scores for SELENA-SLEDAI, BILAG (General and Musculoskeletal) ratings, and Physician's Global Assessment (PGA). Patients showing improvement in PGA and meeting the BILAG responder criteria had significantly higher mean improvement in FACIT-Fatigue scores than those without improvements in either measure (Week 52 mean score difference [95% confidence interval]: - 4.0 [- 5.0, - 3.0] and -2.2 [-3.1, -1.2], respectively; both p < 0.0001). The range of important (i.e. meaningful) change in FACIT-Fatigue, based on multiple anchors, was 3-6 points. CONCLUSIONS The FACIT-Fatigue demonstrated adequate psychometric properties in patients with SLE. The body of evidence from the three BLISS trials (both pooled and individually) supports the FACIT-Fatigue as a reliable and valid measure of SLE-related fatigue in clinical trials. CLINICAL TRIAL IDENTIFIERS BLISS-SC (NCT01484496), BLISS-52 (NCT00424476), and BLISS-76 (NCT00410384).",2021,"Known-groups validity testing showed that the FACIT-Fatigue can significantly discriminate between patient groups with differing scores for SELENA-SLEDAI, BILAG (General and Musculoskeletal) ratings, and Physician's Global Assessment (PGA).","['Subjects with Systemic lupus erythematosus (BLISS', 'systemic lupus erythematosus', 'patients with SLE', 'patients with systemic lupus erythematosus (SLE']","['Chronic Illness Therapy (FACIT)-Fatigue', 'FACIT-Fatigue', 'BeLimumab']","['Internal consistency, test-retest reliability, convergent validity, and ability to detect changes in SLE', 'General/Musculoskeletal scores', 'FACIT-Fatigue and the Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) scores and SLE annualised flare rate', 'FACIT-Fatigue', 'moderate-strong convergent validity', 'FACIT-Fatigue scores']","[{'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C1723401', 'cui_str': 'belimumab'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1723401', 'cui_str': 'belimumab'}]","[{'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0409974', 'cui_str': 'Lupus erythematosus'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0451528', 'cui_str': 'Systemic lupus erythematosus disease activity index'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0442821', 'cui_str': 'Strong'}]",,0.357477,"Known-groups validity testing showed that the FACIT-Fatigue can significantly discriminate between patient groups with differing scores for SELENA-SLEDAI, BILAG (General and Musculoskeletal) ratings, and Physician's Global Assessment (PGA).","[{'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Rendas-Baum', 'Affiliation': 'Optum, Johnston, RI, USA. rrbaum@qualitymetric.com.'}, {'ForeName': 'Nishtha', 'Initials': 'N', 'LastName': 'Baranwal', 'Affiliation': 'Optum, Johnston, RI, USA.'}, {'ForeName': 'Ashish V', 'Initials': 'AV', 'LastName': 'Joshi', 'Affiliation': 'GSK, Value Evidence & Outcomes, Collegeville, PA, USA.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'GSK, Value Evidence & Outcomes, Collegeville, PA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kosinski', 'Affiliation': 'Optum, Johnston, RI, USA.'}]",Journal of patient-reported outcomes,['10.1186/s41687-021-00298-x'] 3167,33830370,Vascular access for renal replacement therapy among 459 critically ill patients: a pragmatic analysis of the randomized AKIKI trial.,"BACKGROUND Vascular access for renal replacement therapy (RRT) is routine question in the intensive care unit. Randomized trials comparing jugular and femoral sites have shown similar rate of nosocomial events and catheter dysfunction. However, recent prospective observational data on RRT catheters use are scarce. We aimed to assess the site of RRT catheter, the reasons for catheter replacement, and the complications according to site in a large population of critically ill patients with acute kidney injury. PATIENTS AND METHODS We performed an ancillary study of the AKIKI study, a pragmatic randomized controlled trial, in which patients with severe acute kidney injury (KDIGO 3 classification) with invasive mechanical ventilation, catecholamine infusion or both were randomly assigned to either an early or a delayed RRT initiation strategy. The present study involved all patients who underwent at least one RRT session. Number of RRT catheters, insertion sites, factors potentially associated with the choice of insertion site, duration of catheter use, reason for catheter replacement, and complications were prospectively collected. RESULTS Among the 619 patients included in AKIKI, 462 received RRT and 459 were finally included, with 598 RRT catheters. Femoral site was chosen preferentially (n = 319, 53%), followed by jugular (n = 256, 43%) and subclavian (n = 23, 4%). In multivariate analysis, continuous RRT modality was significantly associated with femoral site (OR = 2.33 (95% CI (1.34-4.07), p = 0.003) and higher weight with jugular site [88.9 vs 83.2 kg, OR = 0.99 (95% CI 0.98-1.00), p = 0.03]. Investigator site was also significantly associated with the choice of insertion site (p = 0.03). Cumulative incidence of catheter replacement did not differ between jugular and femoral site [sHR 0.90 (95% CI 0.64-1.25), p = 0.67]. Catheter dysfunction was the main reason for replacement (n = 47), followed by suspected infection (n = 29) which was actually seldom proven (n = 4). No mechanical complication (pneumothorax or hemothorax) occurred. CONCLUSION Femoral site was preferentially used in this prospective study of RRT catheters in 31 French intensive care units. The choice of insertion site depended on investigating center habits, weight, RRT modality. A high incidence of catheter infection suspicion led to undue replacement.",2021,"Cumulative incidence of catheter replacement did not differ between jugular and femoral site [sHR 0.90 (95% CI 0.64-1.25), p = 0.67].","['critically ill patients with acute kidney injury', '619 patients included in AKIKI, 462 received RRT and 459 were finally included, with 598 RRT catheters', '459 critically ill patients', 'patients who underwent at least one RRT session', '31 French intensive care units', 'patients with severe acute kidney injury (KDIGO 3 classification) with invasive mechanical ventilation, catecholamine infusion or both']","['delayed RRT initiation strategy', 'renal replacement therapy (RRT', 'RRT catheters', 'renal replacement therapy']","['rate of nosocomial events and catheter dysfunction', 'higher weight with jugular site', 'femoral site', 'mechanical complication (pneumothorax or hemothorax', 'Cumulative incidence of catheter replacement', 'Catheter dysfunction', 'Vascular access']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0007412', 'cui_str': 'Catecholamine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}]","[{'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C4761194', 'cui_str': 'Catheter dysfunction'}, {'cui': 'C0948775', 'cui_str': 'High weight'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0019123', 'cui_str': 'Hemothorax'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0522774', 'cui_str': 'Replacement of catheter'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0444454', 'cui_str': 'Access'}]",619.0,0.0567418,"Cumulative incidence of catheter replacement did not differ between jugular and femoral site [sHR 0.90 (95% CI 0.64-1.25), p = 0.67].","[{'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Benichou', 'Affiliation': 'AP-HP, Hôpital Européen Georges Pompidou, Service de Néphrologie, 75015, Paris, France.'}, {'ForeName': 'Saïd', 'Initials': 'S', 'LastName': 'Lebbah', 'Affiliation': 'Département de Biostatistiques, Santé Publique Et Information Médicale, AP-HP, Hôpital Pitié-Salpêtrière, 75013, Paris, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hajage', 'Affiliation': 'Département de Biostatistiques, Santé Publique Et Information Médicale, AP-HP, Hôpital Pitié-Salpêtrière, 75013, Paris, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Martin-Lefèvre', 'Affiliation': 'Réanimation Médico-Chirurgicale, CHG, La Roche-sur-Yon, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Pons', 'Affiliation': 'Service de Réanimation, CHU de Pointe À Pitre-Abymes, CHU de La Guadeloupe, Pointe-à-Pitre, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Boulet', 'Affiliation': 'Réanimation Polyvalente, CH René Dubos, 95301, Pontoise, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Boyer', 'Affiliation': 'Réanimation Médicale CHU Bordeaux, Hôpital Pellegrin, 33000, Bordeaux, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Chevrel', 'Affiliation': 'Service de Réanimation, Centre Hospitalier Sud Francilien, Corbeil Essonne, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Lerolle', 'Affiliation': ""Département de Réanimation Médicale Et Médecine Hyperbare, CHU Angers, Université D'Angers, Angers, France.""}, {'ForeName': 'Dorothée', 'Initials': 'D', 'LastName': 'Carpentier', 'Affiliation': 'Réanimation Médicale, CHU Rouen, 76000, Rouen, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'de Prost', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris, Hôpitaux Universitaires Henri Mondor, DHU A-TVB, Service de Réanimation Médicale, Créteil, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Lautrette', 'Affiliation': 'Réanimation Médicale, Hôpital Gabriel Montpied, CHU de Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bretagnol', 'Affiliation': ""Réanimation Médico-Chirurgicale, Hôpital de La Source, Centre Hospitalier Régional D'Orléans, BP 6709, 45067, Orléans Cedex, France.""}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Mayaux', 'Affiliation': 'Service de Pneumologie Et Réanimation Médicale, APHP, Groupe Hospitalier Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Saad', 'Initials': 'S', 'LastName': 'Nseir', 'Affiliation': 'Centre de Réanimation, CHU de Lille, Faculté de Médecine, Université de Lille, 59000, Lille, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Megarbane', 'Affiliation': 'Réanimation Médicale Et Toxicologique, Hôpital Lariboisière, INSERM U1144, Université Paris-Diderot, Paris, France.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Thirion', 'Affiliation': 'Réanimation Polyvalente, CH Victor Dupouy, 95107, Argenteuil Cedex, France.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Forel', 'Affiliation': 'Service de Réanimation Des Détresses Respiratoires Aiguës Et Infections Sévères, Hôpital Nord Marseille, 13015, Marseille, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Maizel', 'Affiliation': 'Service de Réanimation Médicale INSERM U1088, Centre Hospitalier Universitaire de Picardie, Amiens, France.'}, {'ForeName': 'Hodane', 'Initials': 'H', 'LastName': 'Yonis', 'Affiliation': 'Réanimation Médicale, Hôpital de La Croix Rousse, 69004, Lyon, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Markowicz', 'Affiliation': 'Réanimation, CH Cholet, 49300, Cholet, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Thiery', 'Affiliation': 'Service de Réanimation, CHU de Pointe À Pitre-Abymes, CHU de La Guadeloupe, Pointe-à-Pitre, France.'}, {'ForeName': 'Frederique', 'Initials': 'F', 'LastName': 'Schortgen', 'Affiliation': 'Centre Hospitalier Inter-Communal, Service de Réanimation Polyvalente Adulte, Créteil, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Tubach', 'Affiliation': 'Département de Biostatistiques, Santé Publique Et Information Médicale, AP-HP, Hôpital Pitié-Salpêtrière, 75013, Paris, France.'}, {'ForeName': 'Jean-Damien', 'Initials': 'JD', 'LastName': 'Ricard', 'Affiliation': 'Univ Paris Diderot, Sorbonne Paris Cité, IAME, UMRS 1137, 75018, Paris, France.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Dreyfuss', 'Affiliation': 'AP-HP, Service de Réanimation Médico-Chirurgicale, Hôpital Louis Mourier, 92700, Colombes, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Gaudry', 'Affiliation': 'French National Institute of Health and Medical Research (INSERM), UMR_S1155, Remodeling and Repair of Renal Tissue, Hôpital Tenon, Sorbonne Université, 75020, Paris, France. stephanegaudry@gmail.com.'}]",Annals of intensive care,['10.1186/s13613-021-00843-3'] 3168,32534658,Association of poor sleep quality with risk factors after coronary artery bypass graft surgery-A prospective cohort study.,"Fragmented sleep is a daunting experience and a common health problem with high prevalence among patients 3 months after coronary artery bypass grafting (CABG). However, the potential predictors on poor seep quality remains unexplored. The main purpose of this study was to determine the predictors of poor sleep quality among patients 3 months after CABG. A prospective cohort study is a part of the randomized controlled trial between 2012 and 2013 in which 400 adult patients undergoing elective CABG were being randomly sampled as per the inclusion criteria followed up at 3 months after CABG surgery in the cardiovascular outpatient clinic of a tertiary-care hospital. The study was conducted according to the Declaration of Helsinki and was approved by the institutional ethical committee. All participants gave written informed consent on having received detailed information on the study. Demographic and clinical data were obtained from medical records at the time of CABG. The data on sleep quality were collected by using the Pittsburgh Sleep Quality Index and state anxiety was evaluated utilizing state-trait anxiety inventory (STAI-YI fo3rm). Multivariable logistic regression examined the association between the postoperative poor sleep quality and clinical, preoperative state anxiety, and angina. The significant variables are chosen based on the P-value associated with the significant level of model that lies on α = 0.05. Logit determination and the correlation between the variables are also discussed for further analysis. A total of 187 patients (mean age 55.6 ± 12.05 years) completed the questionnaire. Most patients (78%) reported poor sleep quality (4.23 ± 1.24) (PQSI score of less than 5). There was a strong relationship between PQSI and state anxiety. The higher state anxiety among 68% of patients with the mean score (53.51 ± 9.55) had 6.42 (95% CI 3.04-9.61) times the odds of being classified as high risk for sleep disturbance. There are 3 factors that most significant of the 8 factors tested were identified as having influence significantly on the poor sleep quality. These factors are diabetes (OR 1.186, 95% CI 1.016-1.097, P > .01), body mass index > 30 kg/m 2 (OR 2.36, 95% CI 1.041-1.172, P > .05), sedentary lifestyle (OR 1.091, 95% CI 1.016-1.159, P > .01), and preoperative state anxiety (OR 1.186, 95% CI 1.074-1.115, P > .01). Even though the body mass index>30 kg/m 2 , sedentary lifestyle, and diabetes were significantly associated with sleep quality, the only factor with more significantly related to poor sleep quality was preoperative state anxiety which is the strong predictor of poor sleep quality. Hence, early recognition of predictors and careful management of poor sleep quality is warranted.",2020,Most patients (78%) reported poor sleep quality (4.23 ± 1.24) (,"['patients 3\xa0months after CABG', '187 patients (mean age 55.6\xa0±\xa012.05\xa0years) completed the questionnaire', 'patients 3\xa0months after coronary artery bypass grafting (CABG', '2012 and 2013 in which 400 adult patients undergoing elective CABG were being randomly sampled as per the inclusion criteria followed up at 3\xa0months after CABG surgery in the cardiovascular outpatient clinic of a tertiary-care hospital']",['coronary artery bypass graft surgery'],"['sleep quality', 'sedentary lifestyle', 'postoperative poor sleep quality and clinical, preoperative state anxiety, and angina', 'PQSI score', 'body mass index', 'poor sleep quality', 'PQSI and state anxiety', 'higher state anxiety', 'preoperative state anxiety', 'Pittsburgh Sleep Quality Index and state anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0178808', 'cui_str': 'Preoperative state'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}]",400.0,0.0281365,Most patients (78%) reported poor sleep quality (4.23 ± 1.24) (,"[{'ForeName': 'Akila', 'Initials': 'A', 'LastName': 'Muthukrishnan', 'Affiliation': 'Assistant Professor, School of Nursing, College of Pharmacy and Nursing, University of Nizwa, Sultanate of Oman. Electronic address: akila@unizwa.edu.om.'}, {'ForeName': 'Thoddi Ramamurthy', 'Initials': 'TR', 'LastName': 'Muralidharan', 'Affiliation': 'Professor & Head, Department of Cardiology, Sri Ramachandra Institute of Higher Education & Research (Deemed to be University), Chennai, Tamil Nadu, India.'}, {'ForeName': 'Jeyagowri', 'Initials': 'J', 'LastName': 'Subash', 'Affiliation': 'Principal, Rani Meyyammai College of Nursing, Annamalai University, Chidambaram, Tamil Nadu, India.'}, {'ForeName': 'Chinnasamy', 'Initials': 'C', 'LastName': 'Lathamangeswari', 'Affiliation': 'Principal, Jothi College of Management Science & Technology, Bareilly, Uttarpradesh, India.'}]",Journal of vascular nursing : official publication of the Society for Peripheral Vascular Nursing,['10.1016/j.jvn.2020.02.001'] 3169,32323191,Associations between model-predicted rivaroxaban exposure and patient characteristics and efficacy and safety outcomes in the treatment of venous thromboembolism.,"Anticoagulant plasma concentrations and patient characteristics might affect the benefit-risk balance of therapy. This study assessed the impact of model-predicted rivaroxaban exposure and patient characteristics on outcomes in patients receiving rivaroxaban for venous thromboembolism treatment (VTE-T) using data from the phase 3 EINSTEIN-DVT and EINSTEIN-PE studies. In the absence of measured rivaroxaban exposure, exposure estimates were predicted based on individual increases in prothrombin time (PT) and the known correlation between rivaroxaban plasma concentrations and PT dynamics. The composite efficacy outcomes evaluated were recurrent deep-vein thrombosis (DVT) and pulmonary embolism (PE) and recurrent DVT, PE and all-cause death; safety outcomes were major bleeding and the composite of major or non-major clinically relevant (NMCR) bleeding. Exposure-response relationships were evaluated using multivariate logistic and Cox regression for the twice-daily (BID) and once-daily (OD) dosing periods, respectively. Predicted rivaroxaban exposure and CrCl were significantly associated with both efficacy outcomes in the BID period. In the OD period, exposure was significantly associated with recurrent DVT and PE but not recurrent DVT, PE and all-cause death. The statistically significant exposure-efficacy relationships were shallow. Exposure-safety relationships were absent within the investigated exposure range. During both dosing periods, low baseline hemoglobin and prior bleeding were associated with the composite of major or NMCR bleeding. In conclusion, based on the underlying data and analysis, no reliable target window for exposure with improved benefit-risk could be identified within the investigated exposure range. Therefore, monitoring rivaroxaban levels is unlikely to be beneficial in VTE-T.",2020,"In the OD period, exposure was significantly associated with recurrent DVT and PE but not recurrent DVT, PE and all-cause death.",['patients receiving rivaroxaban for venous thromboembolism treatment (VTE-T'],['rivaroxaban'],"['prothrombin time (PT', 'recurrent deep-vein thrombosis (DVT) and pulmonary embolism (PE) and recurrent DVT, PE and all-cause death; safety outcomes were major bleeding and the composite of major or non-major clinically relevant (NMCR) bleeding', 'low baseline hemoglobin and prior bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}]","[{'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C1735901', 'cui_str': 'Recurrent deep vein thrombosis'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0332152', 'cui_str': 'Before'}]",,0.108081,"In the OD period, exposure was significantly associated with recurrent DVT and PE but not recurrent DVT, PE and all-cause death.","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Solms', 'Affiliation': 'Clinical Pharmacometrics, Bayer AG, Berlin, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Willmann', 'Affiliation': 'Clinical Pharmacometrics, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Reinecke', 'Affiliation': 'Bayer AB, Solna, Sweden.'}, {'ForeName': 'Theodore E', 'Initials': 'TE', 'LastName': 'Spiro', 'Affiliation': 'Bayer U.S., LLC, Research & Development, Pharmaceuticals, 100 Bayer Boulevard, Whippany, NJ, 07981, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Peters', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Jeffrey I', 'Initials': 'JI', 'LastName': 'Weitz', 'Affiliation': 'McMaster University and the Thrombosis & Atherosclerosis, Hamilton, ON, Canada.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Mueck', 'Affiliation': 'Clinical Pharmacokinetics, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Garmann', 'Affiliation': 'Clinical Pharmacometrics, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': 'Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, FL, USA.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Keith A A', 'Initials': 'KAA', 'LastName': 'Fox', 'Affiliation': 'Centre for Cardiovascular Science, The University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Bayer U.S., LLC, Research & Development, Pharmaceuticals, 100 Bayer Boulevard, Whippany, NJ, 07981, USA. scott.berkowitz@bayer.com.'}]",Journal of thrombosis and thrombolysis,['10.1007/s11239-020-02073-z'] 3170,33548159,Advanced colorectal cancer subtypes (aCRCS) help select oxaliplatin-based or irinotecan-based therapy for colorectal cancer.,"Oxaliplatin (OX) and irinotecan (IRI) are used as key drugs for the first-line treatment of metastatic colorectal cancer (mCRC). However, no biomarkers have been identified to decide which of the drugs is initially used. In this translational research (TR) of the TRICOLORE trial, the advanced colorectal cancer subtype (aCRCS) was analyzed as a potential biomarker for the selection of OX or IRI. We collected 335 (68.8%) formalin-fixed, paraffin-embedded (FFPE) primary tumor specimens from 487 patients registered in the TRICOLORE trial and performed direct sequencing and immunohistochemical staining of CRC-related genes, comprehensive gene-expression analysis, and genome-wide methylation analysis. The progression-free survival (PFS) of the IRI group was significantly better compared with the OX group in BRAF wild-type (WT), PTEN-positive, and aCRCS A1 patients. Among the molecular factors, aCRCS were only associated with the PFS of OX and IRI groups. The PFS of the IRI group was significantly better compared with the OX group in aCRCS A1 + B1 (hazard ratio [HR] = 0.58; 95% confidence interval [CI] = 0.41-0.82; P = .0023). In contrast, the OX group had better PFS compared with the IRI group in aCRCS B2, although this was not statistically significant (HR = 1.66; 95% CI = 0.94-2.96; P = .083). Nearly half of patients with mCRC (46.8%, aCRCS A1 + B1) respond well to IRI, while only about 18.5% (aCRCS B2) of patients with mCRC responded well to OX. In conclusion, the aCRCS might be a predictive factor for the clinical outcomes of OX-based and IRI-based therapies.",2021,The PFS of the IRI group was significantly better compared with the OX group in aCRCS A1 + B1 (hazard ratio [HR] = 0.58; 95% confidence interval [CI] =,"['Advanced colorectal cancer subtypes (aCRCS', 'advanced colorectal cancer subtype (aCRCS', 'colorectal cancer', 'metastatic colorectal cancer (mCRC']","['OX', 'Oxaliplatin (OX) and irinotecan (IRI', 'oxaliplatin-based or irinotecan-based therapy']","['PFS', 'progression-free survival (PFS']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0022077', 'cui_str': 'Iris structure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",487.0,0.0565407,The PFS of the IRI group was significantly better compared with the OX group in aCRCS A1 + B1 (hazard ratio [HR] = 0.58; 95% confidence interval [CI] =,"[{'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Takahashi', 'Affiliation': 'Department of Medical Oncology, Tohoku University Hospital, Miyagi, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Medical Oncology, Osaki Citizen Hospital, Miyagi, Japan.'}, {'ForeName': 'Tadamichi', 'Initials': 'T', 'LastName': 'Denda', 'Affiliation': 'Division of Gastroenterology, Chiba Cancer Center, Chiba, Japan.'}, {'ForeName': 'Atsuo', 'Initials': 'A', 'LastName': 'Takashima', 'Affiliation': 'Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yoshito', 'Initials': 'Y', 'LastName': 'Komatsu', 'Affiliation': 'Department of Cancer Chemotherapy, Hokkaido University Hospital Cancer Center, Hokkaido, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Aizawa Comprehensive Cancer Center, Aizawa Hospital, Nagano, Japan.'}, {'ForeName': 'Hisatsugu', 'Initials': 'H', 'LastName': 'Ohori', 'Affiliation': 'Department of Medical Oncology, Japanese Red Cross Ishinomaki Hospital, Miyagi, Japan.'}, {'ForeName': 'Tatsuro', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.'}, {'ForeName': 'Yoshimitsu', 'Initials': 'Y', 'LastName': 'Kobayashi', 'Affiliation': 'Gastroenterology and Medical Oncology, KKR Sapporo Medical Center, Hokkaido, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Baba', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Kotake', 'Affiliation': 'Department of Surgery, Kouseiren Takaoka Hospital, Toyama, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Amagai', 'Affiliation': 'Division of Gastroenterology, Ibaraki Prefectural Central Hospital, Ibaraki, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Kondo', 'Affiliation': 'Division of Gastroenterology, Tonan Hospital, Hokkaido, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Shimada', 'Affiliation': 'Department of Internal Medicine, Division of Medical Oncology, Showa University Koto Toyosu Hospital, Tokyo, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Sato', 'Affiliation': 'Department of Medical Oncology, Hirosaki University Graduate School of Medicine, Aomori, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yuki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Hokkaido University Hospital, Hokkaido, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Okita', 'Affiliation': 'Department of Medical Oncology, Tohoku University Hospital, Miyagi, Japan.'}, {'ForeName': 'Kota', 'Initials': 'K', 'LastName': 'Ouchi', 'Affiliation': 'Department of Medical Oncology, Tohoku University Hospital, Miyagi, Japan.'}, {'ForeName': 'Keigo', 'Initials': 'K', 'LastName': 'Komine', 'Affiliation': 'Department of Medical Oncology, Tohoku University Hospital, Miyagi, Japan.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Department of Pathology, Tohoku University Hospital, Miyagi, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Chikashi', 'Initials': 'C', 'LastName': 'Ishioka', 'Affiliation': 'Department of Medical Oncology, Tohoku University Hospital, Miyagi, Japan.'}]",Cancer science,['10.1111/cas.14841'] 3171,32229277,Cutaneous absorption of tretinoin in 0.05% cream and 5% chemical peel formulas.,,2020,,[],['tretinoin'],[],[],"[{'cui': 'C0040845', 'cui_str': 'Tretinoin'}]",[],,0.057331,,"[{'ForeName': 'Ana Claudia Pompeu', 'Initials': 'ACP', 'LastName': 'Raminelli', 'Affiliation': 'Department of Medicine, Paulista School of Medicine, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Andre Felipe', 'Initials': 'AF', 'LastName': 'Rodrigues-Oliveira', 'Affiliation': 'Environmental, Chemical and Pharmaceutical Sciences Institute, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Yokota', 'Affiliation': 'Department of Medicine, Paulista School of Medicine, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Juliana Mayumi', 'Initials': 'JM', 'LastName': 'Sumita', 'Affiliation': 'Department of Medicine, Paulista School of Medicine, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Diogo', 'Initials': 'D', 'LastName': 'Oliveira-Silva', 'Affiliation': 'Environmental, Chemical and Pharmaceutical Sciences Institute, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Carlos Gustavo', 'Initials': 'CG', 'LastName': 'Wambier', 'Affiliation': 'Department of Dermatology, Alpert Medical School of Brown University, Providence, Rhode Island. Electronic address: carlos_wambier@brown.edu.'}, {'ForeName': 'Edileia', 'Initials': 'E', 'LastName': 'Bagatin', 'Affiliation': 'Department of Dermatology, Paulista School of Medicine, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Gislaine Ricci', 'Initials': 'GR', 'LastName': 'Leonardi', 'Affiliation': 'Department of Medicine, Paulista School of Medicine, Federal University of São Paulo, São Paulo, Brazil; School of Pharmaceutical Sciences, University of Campinas, Campinas, Brazil.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.03.045'] 3172,33615628,First-in-human study of the cancer peptide vaccine TAS0313 in patients with advanced solid tumors.,"TAS0313, a novel cancer vaccine cocktail, was developed to overcome the disadvantages of previously developed short and long peptide vaccines; it comprises several long peptides targeting multiple cancer antigens. We evaluated TAS0313 monotherapy in Japanese patients with advanced solid tumors for which no other therapies were available. In the dose-finding cohort, patients received TAS0313 (9 or 27 mg) on days 1, 8, and 15 of cycles 1 and 2, and then on day 1 of each subsequent 21-day cycle. The primary objective was the evaluation of safety and tolerability. Secondary objectives were evaluation of efficacy, tumor responses, and immune activation (CTL, IgG, and tumor-infiltrating lymphocyte [TIL] levels). The full analysis set contained 10 patients in the 9-mg group and seven in the 27-mg group. No dose-limiting toxicities were reported in cycle 1. All adverse drug reactions (ADRs) were grade 1 or 2; the most common ADRs were injection site-related events. The best response was stable disease in four of 17 patients. The median progression-free survival (PFS) duration was 2.2 (95% confidence interval, 1.0-2.3) months overall; patients with baseline low lymphocyte counts (≤750/μL) had shorter PFS. Compared with baseline, TILs were increased in five patients. Although CTLs, IgG, and TILs were induced, no correlative pattern with clinical outcomes was observed. The safety, tolerability, and induction of immune responses in patients with advanced solid tumors receiving TAS0313 were confirmed. Further evaluation of TAS0313's efficacy as monotherapy or in combination with pembrolizumab is underway. The study is registered at www.clinicaltrials.jp (JapicCTI-183824).",2021,"The median progression-free survival (PFS) duration was 2.2 (95% confidence interval, 1.0-2.3) months overall; patients with baseline low lymphocyte counts (≤750/μL) had shorter PFS.","['patients with advanced solid tumors receiving TAS0313 were confirmed', 'patients with advanced solid tumors', 'Japanese patients with advanced solid tumors']","['TAS0313 monotherapy', 'TAS0313', 'cancer peptide vaccine TAS0313']","['All adverse drug reactions (ADRs', 'No dose-limiting toxicities', 'evaluation of efficacy, tumor responses, and immune activation (CTL, IgG, and tumor-infiltrating lymphocyte [TIL] levels', 'safety, tolerability, and induction of immune responses', 'safety and tolerability', 'median progression-free survival (PFS) duration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0599934', 'cui_str': 'Peptide Vaccines'}]","[{'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0039195', 'cui_str': 'Cytotoxic T lymphocyte'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0079722', 'cui_str': 'Tumor-Infiltrating Lymphocytes'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",,0.174945,"The median progression-free survival (PFS) duration was 2.2 (95% confidence interval, 1.0-2.3) months overall; patients with baseline low lymphocyte counts (≤750/μL) had shorter PFS.","[{'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Kondo', 'Affiliation': 'Department of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Shimizu', 'Affiliation': 'Department of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Koyama', 'Affiliation': 'Department of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Sato', 'Affiliation': 'Department of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Iwasa', 'Affiliation': 'Department of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Kan', 'Initials': 'K', 'LastName': 'Yonemori', 'Affiliation': 'Department of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Shimomura', 'Affiliation': 'Department of Breast and Medical Oncology, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Shigehisa', 'Initials': 'S', 'LastName': 'Kitano', 'Affiliation': 'Department of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': 'Department of Breast and Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Noboru', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan.'}]",Cancer science,['10.1111/cas.14765'] 3173,33837380,Supervised exercise after oesophageal cancer surgery: the PERFECT multicentre randomized clinical trial.,"BACKGROUND This study investigated whether a supervised exercise programme improves quality of life (QoL), fatigue and cardiorespiratory fitness in patients in the first year after oesophagectomy. METHODS The multicentre PERFECT trial randomly assigned patients to an exercise intervention (EX) or usual care (UC) group. EX patients participated in a 12-week moderate- to high-intensity aerobic and resistance exercise programme supervised by a physiotherapist. Primary (global QoL, QoL summary score) and secondary (QoL subscales, fatigue and cardiorespiratory fitness) outcomes were assessed at baseline, 12 and 24 weeks and analysed as between-group differences using either linear mixed effects models or ANCOVA. RESULTS A total of 120 patients (mean(s.d.) age 64(8) years) were included and randomized to EX (61 patients) or UC (59 patients). Patients in the EX group participated in 96 per cent (i.q.r. 92-100 per cent) of the exercise sessions and the relative exercise dose intensity was high (92 per cent). At 12 weeks, beneficial EX effects were found for QoL summary score (3.5, 95 per cent c.i. 0.2 to 6.8) and QoL role functioning (9.4, 95 per cent c.i. 1.3 to 17.5). Global QoL was not statistically significant different between groups (3.0, 95 per cent c.i. -2.2 to 8.2). Physical fatigue was lower in the EX group (-1.2, 95 per cent c.i. -2.6 to 0.1), albeit not significantly. There was statistically significant improvement in cardiorespiratory fitness following EX compared with UC (peak oxygen uptake (1.8 ml/min/kg, 95 per cent c.i. 0.6 to 3.0)). After 24 weeks, all EX effects were attenuated. CONCLUSIONS A supervised exercise programme improved cardiorespiratory fitness and aspects of QoL. TRIAL REGISTRATION Dutch Trial Register NTR 5045 (www.trialregister.nl/trial/4942).",2021,"There was statistically significant improvement in cardiorespiratory fitness following EX compared with UC (peak oxygen uptake (1.8 ml/min/kg, 95 per cent c.i.","['120 patients (mean(s.d', 'age 64(8) years) were included and randomized to EX (61 patients) or UC (59 patients', 'patients in the first year after oesophagectomy', 'after oesophageal cancer surgery']","['Supervised exercise', 'exercise intervention (EX) or usual care (UC', 'EX', 'supervised exercise programme', 'moderate- to high-intensity aerobic and resistance exercise programme supervised by a physiotherapist']","['cardiorespiratory fitness', 'relative exercise dose intensity', 'QoL role functioning', 'UC (peak oxygen uptake', 'quality of life (QoL), fatigue and cardiorespiratory fitness', 'Primary (global QoL, QoL summary score) and secondary (QoL subscales, fatigue and cardiorespiratory fitness) outcomes', 'beneficial EX effects', 'Physical fatigue', 'Global QoL', 'QoL summary score', 'EX effects']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0546837', 'cui_str': 'Malignant tumor of esophagus'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",120.0,0.17516,"There was statistically significant improvement in cardiorespiratory fitness following EX compared with UC (peak oxygen uptake (1.8 ml/min/kg, 95 per cent c.i.","[{'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'van Vulpen', 'Affiliation': 'Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Hiensch', 'Affiliation': 'Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'van Hillegersberg', 'Affiliation': 'Department of Surgery, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Ruurda', 'Affiliation': 'Department of Surgery, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'F J G', 'Initials': 'FJG', 'LastName': 'Backx', 'Affiliation': 'Department of Rehabilitation, Physical Therapy Science & Sport, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'G A P', 'Initials': 'GAP', 'LastName': 'Nieuwenhuijzen', 'Affiliation': 'Department of Surgery, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Kouwenhoven', 'Affiliation': 'Department of Surgery, ZGT Hospital, Almelo, The Netherlands.'}, {'ForeName': 'R P R', 'Initials': 'RPR', 'LastName': 'Groenendijk', 'Affiliation': 'Department of Surgery, IJsselland Hospital, Capelle a/d IJssel, The Netherlands.'}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'van der Peet', 'Affiliation': 'Department of Surgery, Cancer Centre Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Hazebroek', 'Affiliation': 'Department of Surgery, Rijnstate Hospital, Arnhem, The Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rosman', 'Affiliation': 'Department of Surgery, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'B P L', 'Initials': 'BPL', 'LastName': 'Wijnhoven', 'Affiliation': 'Department of Surgery, Erasmus University Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'M I', 'Initials': 'MI', 'LastName': 'van Berge Henegouwen', 'Affiliation': 'Department of Surgery, Cancer Centre Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'H W M', 'Initials': 'HWM', 'LastName': 'van Laarhoven', 'Affiliation': 'Department of Medical Oncology, Cancer Centre Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'P D', 'Initials': 'PD', 'LastName': 'Siersema', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'May', 'Affiliation': 'Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands.'}]",The British journal of surgery,['10.1093/bjs/znab078'] 3174,33837162,"The Effects of Instrument-Assisted Soft Tissue Mobilization, Tissue Flossing, and Kinesiology Taping on Shoulder Functional Capacities in Amateur Athletes.","CONTEXT Instrument-assisted soft tissue mobilization (IASTM), tissue flossing, and kinesiology taping are increasingly popular treatments among athletes for improving functional performance, despite limited evidence for their efficacy. OBJECTIVE Previous research regarding the efficacy of soft tissues and neuromuscular techniques on improving functional capacity of shoulder joints in athletes has yielded conflicting results. We examined the immediate and short-term effects of IASTM, flossing, and kinesiology taping on the functional capacities of amateur athletes' shoulders. DESIGN Randomized controlled study. SETTING Clinical assessment laboratory. PARTICIPANTS Eighty amateur overhead athletes (mean [SD]: age = 23.03 [1.89]; weight = 78.36 [5.32]; height = 1.77 [.11]). INTERVENTIONS We randomly assigned participants to 4 research sub-groups in which they received the following treatments on their dominant shoulders: IASTM (n = 20), flossing (n = 20), both IASTM and flossing (n = 20), and kinesiology tape (n = 20). Nondominant shoulders served as controls. MAIN OUTCOME MEASURE We evaluated participants-before, immediately after, and 45 minutes after the therapeutic interventions-with the following tests: internal and external shoulder rotation range of motion, isokinetic strength and total work, the functional throwing performance index, and the one-arm seated shot put throw performance. RESULTS All therapeutic interventions significantly improved the strength and functional performance of the dominant shoulder in comparison with the control (P < .005) immediately after and 45 minutes after the treatment. The IASTM led to significantly greater improvement in shoulder internal rotation than kinesiology taping immediately after (P = .049) and 45 minutes after the treatment (P = .049). We observed no significant differences between the other treatment interventions (P > .05). CONCLUSION Findings from the current study support the use of novel soft tissue and neuromuscular techniques for the immediate and short-term improvement of the shoulder functional capacities in amateur overhead athletes.",2021,The IASTM led to significantly greater improvement in shoulder internal rotation than kinesiology taping immediately after (P = .049) and 45 minutes after the treatment (P = .049).,"[""amateur athletes' shoulders"", 'amateur overhead athletes', 'Eighty amateur overhead athletes (mean [SD]: age = 23.03 [1.89]; weight = 78.36 [5.32]; height = 1.77 [.11', 'Amateur Athletes']","['Instrument-Assisted Soft Tissue Mobilization, Tissue Flossing, and Kinesiology Taping', 'IASTM, flossing, and kinesiology taping', 'IASTM and flossing', 'kinesiology tape', 'soft tissue mobilization (IASTM), tissue flossing, and kinesiology taping', 'external shoulder rotation range of motion, isokinetic strength and total work, the functional throwing performance index, and the one-arm seated shot put throw performance']","['shoulder functional capacities', 'strength and functional performance', 'shoulder internal rotation', 'Shoulder Functional Capacities']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}]","[{'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0686940', 'cui_str': 'Soft tissue mobilization'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}]",80.0,0.022755,The IASTM led to significantly greater improvement in shoulder internal rotation than kinesiology taping immediately after (P = .049) and 45 minutes after the treatment (P = .049).,"[{'ForeName': 'Pavlos', 'Initials': 'P', 'LastName': 'Angelopoulos', 'Affiliation': ''}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Mylonas', 'Affiliation': ''}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Tsepis', 'Affiliation': ''}, {'ForeName': 'Evdokia', 'Initials': 'E', 'LastName': 'Billis', 'Affiliation': ''}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Vaitsis', 'Affiliation': ''}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Fousekis', 'Affiliation': ''}]",Journal of sport rehabilitation,['10.1123/jsr.2020-0200'] 3175,33837158,A Pilot Randomized Controlled Trial of Interval Training and Sleep Hygiene for Improving Sleep in Older Adults.,"The primary objective of this pilot randomized controlled trial was to study the feasibility (recruitment and retention rates) for interval training and sleep hygiene (SH) in adults aged above 60 years. Thirteen out of 46 screened individuals from a home for older adults in Shirdi (Maharashtra, India) were randomly assigned by permuted block randomization to either an interval training with SH group (n = 6) or an SH alone group (n = 7). The authors measured sleep with the S+ sleep monitor manufactured by ResMed (USA) Pittsburgh Sleep Quality Index and quality of life with Short Form-12 health survey version 2. Interval training consisted of 8 weeks of stationary cycling, whereas SH consisted of lecture and handouts. Recruitment was 38.2%, retention was >80% for both the interventions, and there was one loss to follow-up in SH. Interval training and SH were feasible for older adults and supported a full-scale randomized controlled trial.",2021,"Recruitment was 38.2%, retention was >80% for both the interventions, and there was one loss to follow-up in SH.","['Older Adults', 'adults aged above 60 years', '46 screened individuals from a home for older adults in Shirdi (Maharashtra, India']","['Interval training and SH', 'interval training with SH', 'SH alone', 'interval training and sleep hygiene (SH', 'Interval Training and Sleep Hygiene']","['feasibility (recruitment and retention rates', 'sleep with the S+ sleep monitor manufactured by ResMed (USA) Pittsburgh Sleep Quality Index and quality of life']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.108857,"Recruitment was 38.2%, retention was >80% for both the interventions, and there was one loss to follow-up in SH.","[{'ForeName': 'Aashirwad', 'Initials': 'A', 'LastName': 'Mahajan', 'Affiliation': ''}, {'ForeName': 'Satish', 'Initials': 'S', 'LastName': 'Mahajan', 'Affiliation': ''}, {'ForeName': 'Swanand', 'Initials': 'S', 'LastName': 'Tilekar', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2020-0207'] 3176,33837140,Invasive placebos in research on peripheral nerve blocks: a follow-up study.,"INTRODUCTION The Serious Harm and Morbidity ""SHAM"" grading system has previously been proposed to categorize the risks associated with the use of invasive placebos in peripheral nerve block research. SHAM grades range from 0 (no potential complications, eg, using standard analgesia techniques as a comparator) through to 4 (risk of major complications, eg, performing a sub-Tenon's block and injecting normal saline). A study in 2011 found that 52% of studies of peripheral nerve blocks had SHAM grades of 3 or more. METHODS We repeated the original study by allocating SHAM grades to randomized controlled studies of peripheral nerve blocks published in English over a 22-month period. Documentation was made of the number of study participants, age, number of controls, body region, adverse events due to invasive placebos and any discussion regarding the ethics of using invasive placebos. We compared the proportion of studies with SHAM grades of 3 or more with the original study. RESULTS In this current study, 114 studies fulfilled the inclusion criteria, 5 pediatric and 109 adult. The SHAM grade was ≥3 in 38 studies (33.3%), with 1494 patients in these control groups collectively. Several studies discussed their reasons for choosing a non-invasive placebo. No pediatric studies had a SHAM grade of ≥3. CONCLUSIONS The use of invasive placebos that may be associated with serious risks in peripheral nerve block research has decreased in contemporary peripheral nerve block research.",2021,"The SHAM grade was ≥3 in 38 studies (33.3%), with 1494 patients in these control groups collectively.","['114 studies fulfilled the inclusion criteria, 5 pediatric and 109 adult', '2011 found that 52% of studies of peripheral nerve blocks had SHAM grades of 3 or more']",['Invasive placebos'],[],"[{'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0198807', 'cui_str': 'Peripheral block anesthesia'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.137396,"The SHAM grade was ≥3 in 38 studies (33.3%), with 1494 patients in these control groups collectively.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Laing', 'Affiliation': ""Children's Anaesthesia, Women's and Children's Hospital Adelaide, North Adelaide, South Australia, Australia.""}, {'ForeName': 'Dana L', 'Initials': 'DL', 'LastName': 'Bolt', 'Affiliation': ""Children's Anaesthesia, Women's and Children's Hospital Adelaide, North Adelaide, South Australia, Australia.""}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Burgoyne', 'Affiliation': ""Children's Anaesthesia, Women's and Children's Hospital Adelaide, North Adelaide, South Australia, Australia laura.burgoyne@sa.gov.au.""}, {'ForeName': 'Cormac J', 'Initials': 'CJ', 'LastName': 'Fahy', 'Affiliation': ""Children's Anaesthesia, Women's and Children's Hospital Adelaide, North Adelaide, South Australia, Australia.""}, {'ForeName': 'Pauline B', 'Initials': 'PB', 'LastName': 'Wake', 'Affiliation': 'School of Medicine and Health Sciences, University of Papua New Guinea, Boroko, Papua New Guinea.'}, {'ForeName': 'Allan M', 'Initials': 'AM', 'LastName': 'Cyna', 'Affiliation': ""Children's Anaesthesia, Women's and Children's Hospital Adelaide, North Adelaide, South Australia, Australia.""}]",Regional anesthesia and pain medicine,['10.1136/rapm-2021-102474'] 3177,33837117,Added Value of Quantitative Apparent Diffusion Coefficient Values for Neuroprognostication After Cardiac Arrest.,"OBJECTIVE To test the prognostic value of brain MRI in addition to clinical and electrophysiological variables in post-cardiac arrest (CA) patients, we explored data from the randomized Neuroprotect post-CA trial (NCT02541591). METHODS In this trial brain MRI's were prospectively obtained. We calculated receiver operating characteristic curves for the average Apparent Diffusion Coefficient (ADC) value and percentage of brain voxels with an ADC value < 650 x 10 -6 mm 2 /s and < 450 x 10 -6 mm 2 /s. We constructed multivariable logistic regression models with clinical characteristics, electroencephalogram (EEG), somatosensory evoked potentials (SSEP) and ADC value as independent variables, to predict good neurological recovery. RESULTS In 79/102 patients MRI data were available and in 58/79 patients all other data were available. At 180 days post-CA, 25/58 (43%) patients had good neurological recovery. In univariable analysis of all tested MRI parameters, average ADC value in the postcentral cortex had the highest accuracy to predict good neurological recovery with an AUC of 0.78. In the most optimal multivariate model which also included corneal reflexes and EEG, this parameter remained an independent predictor of good neurological recovery (AUC = 0.96, false positive = 27%). This model provided a more accurate prediction compared to the most optimal combination of EEG, corneal reflexes and SSEP (p=0.03). CONCLUSION Adding information on brain MRI in a multivariate model may improve the prediction of good neurological recovery in post-CA patients. CLASSIFICATION OF EVIDENCE ""This study provides Class III evidence that MRI ADC features predict neurological recovery in post-cardiac arrest patients.""",2021,"In univariable analysis of all tested MRI parameters, average ADC value in the postcentral cortex had the highest accuracy to predict good neurological recovery with an AUC of 0.78.","['post-cardiac arrest ', 'post-cardiac arrest patients']",['MRI ADC'],"['good neurological recovery', 'clinical characteristics, electroencephalogram (EEG), somatosensory evoked potentials (SSEP) and ADC value']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0015216', 'cui_str': 'Somatosensory evoked potential'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.122471,"In univariable analysis of all tested MRI parameters, average ADC value in the postcentral cortex had the highest accuracy to predict good neurological recovery with an AUC of 0.78.","[{'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Wouters', 'Affiliation': 'Anke Wouters, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium - Department of Neurology, Academic Medical Center, University of Amsterdam, The Netherlands; Lauranne Scheldeman, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium; Sam Plessers, Department of Neurology, University Hospitals Leuven, Leuven, Belgium; Ronald Peeters, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Sarah Capelle, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Philippe Demaerel, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Wim Van Paesschen, Laboratory for Epilepsy Research, Department of Neurosciences, KU Leuven, Leuven, Belgium; Bert Ferdinande, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium; Matthias Dupont, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium; Jo Dens, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium - Faculty of Medicine and Life Sciences, University Hasselt, Diepenbeek, Belgium; Stefan Janssens, Department of Cardiology, University Hospitals Leuven, Leuven, Belgium; Koen Ameloot, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium - Faculty of Medicine and Life Sciences, University Hasselt, Diepenbeek, Belgium - Department of Cardiology, University Hospitals Leuven, Leuven, Belgium; Robin Lemmens, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium; anke.wouters@med.kuleuven.be.'}, {'ForeName': 'Lauranne', 'Initials': 'L', 'LastName': 'Scheldeman', 'Affiliation': 'Anke Wouters, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium - Department of Neurology, Academic Medical Center, University of Amsterdam, The Netherlands; Lauranne Scheldeman, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium; Sam Plessers, Department of Neurology, University Hospitals Leuven, Leuven, Belgium; Ronald Peeters, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Sarah Capelle, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Philippe Demaerel, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Wim Van Paesschen, Laboratory for Epilepsy Research, Department of Neurosciences, KU Leuven, Leuven, Belgium; Bert Ferdinande, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium; Matthias Dupont, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium; Jo Dens, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium - Faculty of Medicine and Life Sciences, University Hasselt, Diepenbeek, Belgium; Stefan Janssens, Department of Cardiology, University Hospitals Leuven, Leuven, Belgium; Koen Ameloot, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium - Faculty of Medicine and Life Sciences, University Hasselt, Diepenbeek, Belgium - Department of Cardiology, University Hospitals Leuven, Leuven, Belgium; Robin Lemmens, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Plessers', 'Affiliation': 'Anke Wouters, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium - Department of Neurology, Academic Medical Center, University of Amsterdam, The Netherlands; Lauranne Scheldeman, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium; Sam Plessers, Department of Neurology, University Hospitals Leuven, Leuven, Belgium; Ronald Peeters, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Sarah Capelle, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Philippe Demaerel, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Wim Van Paesschen, Laboratory for Epilepsy Research, Department of Neurosciences, KU Leuven, Leuven, Belgium; Bert Ferdinande, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium; Matthias Dupont, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium; Jo Dens, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium - Faculty of Medicine and Life Sciences, University Hasselt, Diepenbeek, Belgium; Stefan Janssens, Department of Cardiology, University Hospitals Leuven, Leuven, Belgium; Koen Ameloot, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium - Faculty of Medicine and Life Sciences, University Hasselt, Diepenbeek, Belgium - Department of Cardiology, University Hospitals Leuven, Leuven, Belgium; Robin Lemmens, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Peeters', 'Affiliation': 'Anke Wouters, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium - Department of Neurology, Academic Medical Center, University of Amsterdam, The Netherlands; Lauranne Scheldeman, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium; Sam Plessers, Department of Neurology, University Hospitals Leuven, Leuven, Belgium; Ronald Peeters, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Sarah Capelle, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Philippe Demaerel, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Wim Van Paesschen, Laboratory for Epilepsy Research, Department of Neurosciences, KU Leuven, Leuven, Belgium; Bert Ferdinande, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium; Matthias Dupont, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium; Jo Dens, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium - Faculty of Medicine and Life Sciences, University Hasselt, Diepenbeek, Belgium; Stefan Janssens, Department of Cardiology, University Hospitals Leuven, Leuven, Belgium; Koen Ameloot, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium - Faculty of Medicine and Life Sciences, University Hasselt, Diepenbeek, Belgium - Department of Cardiology, University Hospitals Leuven, Leuven, Belgium; Robin Lemmens, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Cappelle', 'Affiliation': 'Anke Wouters, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium - Department of Neurology, Academic Medical Center, University of Amsterdam, The Netherlands; Lauranne Scheldeman, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium; Sam Plessers, Department of Neurology, University Hospitals Leuven, Leuven, Belgium; Ronald Peeters, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Sarah Capelle, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Philippe Demaerel, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Wim Van Paesschen, Laboratory for Epilepsy Research, Department of Neurosciences, KU Leuven, Leuven, Belgium; Bert Ferdinande, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium; Matthias Dupont, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium; Jo Dens, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium - Faculty of Medicine and Life Sciences, University Hasselt, Diepenbeek, Belgium; Stefan Janssens, Department of Cardiology, University Hospitals Leuven, Leuven, Belgium; Koen Ameloot, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium - Faculty of Medicine and Life Sciences, University Hasselt, Diepenbeek, Belgium - Department of Cardiology, University Hospitals Leuven, Leuven, Belgium; Robin Lemmens, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Demaerel', 'Affiliation': 'Anke Wouters, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium - Department of Neurology, Academic Medical Center, University of Amsterdam, The Netherlands; Lauranne Scheldeman, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium; Sam Plessers, Department of Neurology, University Hospitals Leuven, Leuven, Belgium; Ronald Peeters, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Sarah Capelle, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Philippe Demaerel, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Wim Van Paesschen, Laboratory for Epilepsy Research, Department of Neurosciences, KU Leuven, Leuven, Belgium; Bert Ferdinande, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium; Matthias Dupont, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium; Jo Dens, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium - Faculty of Medicine and Life Sciences, University Hasselt, Diepenbeek, Belgium; Stefan Janssens, Department of Cardiology, University Hospitals Leuven, Leuven, Belgium; Koen Ameloot, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium - Faculty of Medicine and Life Sciences, University Hasselt, Diepenbeek, Belgium - Department of Cardiology, University Hospitals Leuven, Leuven, Belgium; Robin Lemmens, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Wim Van', 'Initials': 'WV', 'LastName': 'Paesschen', 'Affiliation': 'Anke Wouters, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium - Department of Neurology, Academic Medical Center, University of Amsterdam, The Netherlands; Lauranne Scheldeman, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium; Sam Plessers, Department of Neurology, University Hospitals Leuven, Leuven, Belgium; Ronald Peeters, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Sarah Capelle, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Philippe Demaerel, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Wim Van Paesschen, Laboratory for Epilepsy Research, Department of Neurosciences, KU Leuven, Leuven, Belgium; Bert Ferdinande, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium; Matthias Dupont, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium; Jo Dens, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium - Faculty of Medicine and Life Sciences, University Hasselt, Diepenbeek, Belgium; Stefan Janssens, Department of Cardiology, University Hospitals Leuven, Leuven, Belgium; Koen Ameloot, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium - Faculty of Medicine and Life Sciences, University Hasselt, Diepenbeek, Belgium - Department of Cardiology, University Hospitals Leuven, Leuven, Belgium; Robin Lemmens, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Ferdinande', 'Affiliation': 'Anke Wouters, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium - Department of Neurology, Academic Medical Center, University of Amsterdam, The Netherlands; Lauranne Scheldeman, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium; Sam Plessers, Department of Neurology, University Hospitals Leuven, Leuven, Belgium; Ronald Peeters, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Sarah Capelle, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Philippe Demaerel, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Wim Van Paesschen, Laboratory for Epilepsy Research, Department of Neurosciences, KU Leuven, Leuven, Belgium; Bert Ferdinande, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium; Matthias Dupont, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium; Jo Dens, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium - Faculty of Medicine and Life Sciences, University Hasselt, Diepenbeek, Belgium; Stefan Janssens, Department of Cardiology, University Hospitals Leuven, Leuven, Belgium; Koen Ameloot, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium - Faculty of Medicine and Life Sciences, University Hasselt, Diepenbeek, Belgium - Department of Cardiology, University Hospitals Leuven, Leuven, Belgium; Robin Lemmens, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Dupont', 'Affiliation': 'Anke Wouters, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium - Department of Neurology, Academic Medical Center, University of Amsterdam, The Netherlands; Lauranne Scheldeman, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium; Sam Plessers, Department of Neurology, University Hospitals Leuven, Leuven, Belgium; Ronald Peeters, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Sarah Capelle, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Philippe Demaerel, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Wim Van Paesschen, Laboratory for Epilepsy Research, Department of Neurosciences, KU Leuven, Leuven, Belgium; Bert Ferdinande, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium; Matthias Dupont, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium; Jo Dens, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium - Faculty of Medicine and Life Sciences, University Hasselt, Diepenbeek, Belgium; Stefan Janssens, Department of Cardiology, University Hospitals Leuven, Leuven, Belgium; Koen Ameloot, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium - Faculty of Medicine and Life Sciences, University Hasselt, Diepenbeek, Belgium - Department of Cardiology, University Hospitals Leuven, Leuven, Belgium; Robin Lemmens, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Dens', 'Affiliation': 'Anke Wouters, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium - Department of Neurology, Academic Medical Center, University of Amsterdam, The Netherlands; Lauranne Scheldeman, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium; Sam Plessers, Department of Neurology, University Hospitals Leuven, Leuven, Belgium; Ronald Peeters, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Sarah Capelle, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Philippe Demaerel, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Wim Van Paesschen, Laboratory for Epilepsy Research, Department of Neurosciences, KU Leuven, Leuven, Belgium; Bert Ferdinande, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium; Matthias Dupont, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium; Jo Dens, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium - Faculty of Medicine and Life Sciences, University Hasselt, Diepenbeek, Belgium; Stefan Janssens, Department of Cardiology, University Hospitals Leuven, Leuven, Belgium; Koen Ameloot, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium - Faculty of Medicine and Life Sciences, University Hasselt, Diepenbeek, Belgium - Department of Cardiology, University Hospitals Leuven, Leuven, Belgium; Robin Lemmens, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Janssens', 'Affiliation': 'Anke Wouters, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium - Department of Neurology, Academic Medical Center, University of Amsterdam, The Netherlands; Lauranne Scheldeman, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium; Sam Plessers, Department of Neurology, University Hospitals Leuven, Leuven, Belgium; Ronald Peeters, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Sarah Capelle, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Philippe Demaerel, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Wim Van Paesschen, Laboratory for Epilepsy Research, Department of Neurosciences, KU Leuven, Leuven, Belgium; Bert Ferdinande, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium; Matthias Dupont, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium; Jo Dens, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium - Faculty of Medicine and Life Sciences, University Hasselt, Diepenbeek, Belgium; Stefan Janssens, Department of Cardiology, University Hospitals Leuven, Leuven, Belgium; Koen Ameloot, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium - Faculty of Medicine and Life Sciences, University Hasselt, Diepenbeek, Belgium - Department of Cardiology, University Hospitals Leuven, Leuven, Belgium; Robin Lemmens, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Ameloot', 'Affiliation': 'Anke Wouters, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium - Department of Neurology, Academic Medical Center, University of Amsterdam, The Netherlands; Lauranne Scheldeman, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium; Sam Plessers, Department of Neurology, University Hospitals Leuven, Leuven, Belgium; Ronald Peeters, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Sarah Capelle, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Philippe Demaerel, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Wim Van Paesschen, Laboratory for Epilepsy Research, Department of Neurosciences, KU Leuven, Leuven, Belgium; Bert Ferdinande, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium; Matthias Dupont, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium; Jo Dens, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium - Faculty of Medicine and Life Sciences, University Hasselt, Diepenbeek, Belgium; Stefan Janssens, Department of Cardiology, University Hospitals Leuven, Leuven, Belgium; Koen Ameloot, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium - Faculty of Medicine and Life Sciences, University Hasselt, Diepenbeek, Belgium - Department of Cardiology, University Hospitals Leuven, Leuven, Belgium; Robin Lemmens, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Lemmens', 'Affiliation': 'Anke Wouters, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium - Department of Neurology, Academic Medical Center, University of Amsterdam, The Netherlands; Lauranne Scheldeman, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium; Sam Plessers, Department of Neurology, University Hospitals Leuven, Leuven, Belgium; Ronald Peeters, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Sarah Capelle, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Philippe Demaerel, Department of Radiology, University Hospitals Leuven, Leuven, Belgium -Translational MRI, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium; Wim Van Paesschen, Laboratory for Epilepsy Research, Department of Neurosciences, KU Leuven, Leuven, Belgium; Bert Ferdinande, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium; Matthias Dupont, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium; Jo Dens, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium - Faculty of Medicine and Life Sciences, University Hasselt, Diepenbeek, Belgium; Stefan Janssens, Department of Cardiology, University Hospitals Leuven, Leuven, Belgium; Koen Ameloot, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium - Faculty of Medicine and Life Sciences, University Hasselt, Diepenbeek, Belgium - Department of Cardiology, University Hospitals Leuven, Leuven, Belgium; Robin Lemmens, Department of Neurology, University Hospitals Leuven, Leuven, Belgium - VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium - Department of Neurosciences, Experimental Neurology and Leuven Brain Institute, University of Leuven, Leuven, Belgium.'}]",Neurology,['10.1212/WNL.0000000000011991'] 3178,33836826,Randomized clinical trial to compare the efficacy of ivermectin versus placebo to negativize nasopharyngeal PCR in patients with early COVID-19 in Peru (SAINT-Peru): a structured summary of a study protocol for randomized controlled trial.,"OBJECTIVES The primary objective is to determine the effect of a daily dose of ivermectin administered in three consecutive days to non-severe COVID-19 patients with no more than 96 hours of symptoms, on the detection of SARS-CoV-2 RNA by PCR from nasopharyngeal swabs at day seven post-treatment initiation. The secondary objectives are: 1. To assess the efficacy of ivermectin to reduce the SARS-CoV-2 viral load in the nasopharyngeal swab on days 4, 7, 14 and 21 post-treatment initiation 2. To assess the efficacy of ivermectin on the improvement of symptoms 3. To assess the proportion of seroconversions at day 21 4. To assess the safety of ivermectin at the proposed dose 5. To determine the magnitude of the immune response against SARS-CoV-2 6. To assess correlation of the presence of intestinal helminths on participants on baseline and day 14 with COVID-19 progression and treatment. TRIAL DESIGN SAINT PERU is a triple-blinded, randomized, placebo-controlled trial with two parallel arms to evaluate the efficacy of ivermectin in negativizing nasopharyngeal PCR in patients with SARS-CoV-2 infection. PARTICIPANTS The trial is conducted in two national hospitals in Lima-Peru. The study population is patients with a positive PCR test for SARS-CoV-2 in a nasopharyngeal specimen, symptomatic for 96 hours or less, with non-severe COVID-19 disease at baseline, regardless of the presence of risk factors for progression to severity. The study will not include pregnant women or minors (17 years old or younger). Inclusion criteria 1. COVID-19 symptomatology (cough, fever, anosmia, etc.) lasting no more than 96 hours, with a positive nasopharyngeal swab PCR test for SARS-CoV-2. 2. 18 years or older. 3. No use of ivermectin in the month prior to the visit. 4. No known history of ivermectin allergy. 5. Capable to give informed consent. 6. Not current use of CYP 3A4 or P-gp inhibitor drugs such as quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir, cobicistat or critical CYP3A4 substrate drugs such as warfarin. Exclusion criteria 1. COVID-19 pneumonia diagnosed by the attending physician (oxygen saturation < 95% or lung examination) 2. Positive pregnancy test for women at childbearing age. 3. Positive IgG against SARS-CoV-2 by rapid diagnostic test at screening. Participants will be recruited by the investigators at the emergency services of the study sites. They are expected to remain in the trial for a period of 21 days. Follow-up visits will be conducted by the trial medical staff at the participant's home or at a hospital in case of hospitalization. Follow-up visits will assess clinical and laboratory parameters of the patients. INTERVENTION AND COMPARATOR Ivermectin (300 mcg/kg) or placebo will be administered in one daily dose for three consecutive days. Currently, there is no solid data on the efficacy of ivermectin against the virus in vivo; therefore the use of placebo in the control group is ethically justified. MAIN OUTCOMES Primary Proportion of patients with a positive SARS-CoV-2 PCR from a nasopharyngeal swab at day 7 post-treatment. Secondary 1. Mean viral load as determined by PCR cycle threshold (Ct) on days 4, 7, 14, and 21 2. Proportion of patients with fever and cough at days 4, 7, 14, and 21 as well as proportion of patients progressing to severe disease or death during the trial 2. Proportion of patients with a positive rapid diagnostic test at day 21 3. Proportion of drug-related adverse events during the trial 4. Median levels of IgG, IgM, IgA measured by Luminex RANDOMIZATION: Participants will be randomized to receive one dose of 300 mcg/kg ivermectin or placebo daily for three consecutive days. The epidemiologist will generate a list of correlative numbers, in randomized blocks of size 4, with the assignment to the treatment groups (a and b). The randomization list will be kept in an encrypted file accessible only to the trial statistician. This list will be handed directly to the pharmacist. Independently, the principal investigator will randomly assign the intervention (ivermectin) to one of the two groups (a or b) by tossing a coin, and will inform the pharmacist of the result of this process. The pharmacist will prepare and label the treatment vials according to the randomization list prepared by the epidemiologist and the treatment assignment given by the principal investigator. Eligible patients will be allocated in a 1:1 ratio using this randomization list. BLINDING (MASKING) The clinical trial team, the statistician, and the patients will be blinded as to arm allocation. The vials with placebo will be visibly identical to the ones with the active drug. Treatment will be administered by staff not involved in the clinical care or participant's follow up. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE) The planned sample size is 186 SARS-CoV-2 PCR positive patients: 93 patients to treatment and 93 to the placebo group. TRIAL STATUS Current protocol version: 2.0 dated January 15 th , 2021. Recruitment started on Aug 29 th , 2020. Recruitment is expected to be completed April 30 th 2021. TRIAL REGISTRATION ""Ensayo Clínico aleatorizado de Fase IIa para comparar la efectividad de la ivermectina versus placebo en la negativización del PCR en pacientes en fase temprana de COVID-19"" Peru National Health Institute REPEC with number: PER-034-20 , registered July 17 th 2020 (National Peruvian Registration before the first participant enrolled). ""Randomized Phase IIA Clinical Trial to Evaluate the Efficacy of Ivermectin to Obtain Negative PCR Results in Patients With Early Phase COVID-19"" Clinicaltrials.gov: NCT04635943 , retrospectively registered in November 19 th 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2021,"efectividad de la ivermectina versus placebo en la negativización del PCR en pacientes en fase temprana de COVID-19"" Peru National Health Institute REPEC with number: PER-034-20 , registered July 17 th 2020 (National Peruvian Registration before the first participant enrolled). ""","['patients with SARS-CoV-2 infection', 'two national hospitals in Lima-Peru', 'non-severe COVID-19 patients with no more than 96 hours of symptoms, on the detection of SARS-CoV-2 RNA by PCR from nasopharyngeal swabs at day seven post-treatment initiation', 'Eligible patients', 'women at childbearing age', 'Participants will be recruited by the investigators at the emergency services of the study sites', 'Patients With Early Phase COVID-19', 'patients with early COVID-19 in Peru (SAINT-Peru', 'pregnant women or minors (17 years old or younger', '18 years or older', 'para comparar la', 'participants on baseline and day 14 with COVID-19 progression and treatment']","['intervention (ivermectin', 'efectividad de la ivermectina versus placebo', 'quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir, cobicistat or critical CYP3A4 substrate drugs such as warfarin', 'Ivermectin', 'ivermectin or placebo', 'ivermectin', 'placebo']","['Mean viral load', 'positive SARS-CoV-2 PCR', 'SARS-CoV-2 viral load', 'severe disease or death', 'Positive pregnancy test', 'Median levels of IgG, IgM, IgA', 'COVID-19 symptomatology (cough, fever, anosmia, etc']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0242823', 'cui_str': 'Saints'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034414', 'cui_str': 'Quinidine'}, {'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C0012373', 'cui_str': 'Diltiazem'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0042523', 'cui_str': 'Verapamil'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0014806', 'cui_str': 'Erythromycin'}, {'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0022625', 'cui_str': 'Ketoconazole'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0376637', 'cui_str': 'Indinavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C3177235', 'cui_str': 'cobicistat'}, {'cui': 'C1142644', 'cui_str': 'cytochrome P450 3A4 protein, human'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0240802', 'cui_str': 'Pregnancy test positive'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0003126', 'cui_str': 'Loss of sense of smell'}]",,0.650971,"efectividad de la ivermectina versus placebo en la negativización del PCR en pacientes en fase temprana de COVID-19"" Peru National Health Institute REPEC with number: PER-034-20 , registered July 17 th 2020 (National Peruvian Registration before the first participant enrolled). ""","[{'ForeName': 'Patricia J', 'Initials': 'PJ', 'LastName': 'Garcia', 'Affiliation': 'School of Public Health and Administration, Universidad Peruana Cayetano Heredia, Lima, Peru. Patricia.garcia@upch.pe.'}, {'ForeName': 'Hansel', 'Initials': 'H', 'LastName': 'Mundaca', 'Affiliation': 'Instituto de Salud Global (ISGlobal), Barcelona, Spain.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Ugarte-Gil', 'Affiliation': 'School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Leon', 'Affiliation': 'Hospital Nacional Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'German', 'Initials': 'G', 'LastName': 'Malaga', 'Affiliation': 'School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Chaccour', 'Affiliation': 'Instituto de Salud Global (ISGlobal), Barcelona, Spain.'}, {'ForeName': 'Cesar P', 'Initials': 'CP', 'LastName': 'Carcamo', 'Affiliation': 'School of Public Health and Administration, Universidad Peruana Cayetano Heredia, Lima, Peru.'}]",Trials,['10.1186/s13063-021-05236-2'] 3179,33836825,"Primary Care implementation of Germ Defence, a digital behaviour change intervention to improve household infection control during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trial.","OBJECTIVES To examine the effectiveness of randomising dissemination of the Germ Defence behaviour change website via GP practices across England UK. TRIAL DESIGN A two-arm (1:1 ratio) cluster randomised controlled trial implementing Germ Defence via GP practices compared with usual care. PARTICIPANTS Setting: All Primary care GP practices in England. PARTICIPANTS All patients aged 16 years and over who were granted access by participating GP practices. INTERVENTION AND COMPARATOR Intervention: We will ask staff at GP practices randomised to the intervention arm to share the weblink to Germ Defence with all adult patients registered at their practice during the 4-month trial implementation period and care will otherwise follow current standard management. Germ Defence is an interactive website ( http://GermDefence.org/ ) employing behaviour change techniques and practical advice on how to reduce the spread of infection in the home. The coronavirus version of Germ Defence helps people understand what measures to take and when to take them to avoid infection. This includes hand washing, avoiding sharing rooms and surfaces, dealing with deliveries and ventilating rooms. Using behaviour change techniques, it helps users think through and adopt better home hygiene habits and find ways to solve any barriers, providing personalised goal setting and tailored advice that fits users' personal circumstances and problem solving to overcome barriers. Comparator: Patients at GP practices randomised to the usual care arm will receive current standard management for the 4-month trial period after which we will ask staff to share the link to Germ Defence with all adult patients registered at their practice. MAIN OUTCOMES The primary outcome is the effects of implementing Germ Defence on prevalence of all respiratory tract infection diagnoses during the 4-month trial implementation period. The secondary outcomes are: 1) incidence of COVID-19 diagnoses 2) incidence of COVID-19 symptom presentation 3) incidence of gastrointestinal infections 4) number of primary care consultations 5) antibiotic usage 6) hospital admissions 7) uptake of GP practices disseminating Germ Defence to their patients 8) usage of the Germ Defence website by individuals who were granted access by their GP practice RANDOMISATION: GP practices will be randomised on a 1:1 basis by the independent Bristol Randomised Trials Collaboration (BRTC). Clinical Commission Groups (CCGs) in England will be divided into blocks according to region, and equal numbers in each block will be randomly allocated to intervention or usual care. The randomisation schedule will be generated in Stata statistical software by a statistician not otherwise involved in the enrolment of general practices into the study. BLINDING (MASKING) The principal investigators, the statistician and study collaborators will remain blinded from the identity of randomised practices until the end of the study. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) To detect planned effect size (based on PRIMIT trial, Little et al, 2015): 11.1 million respondents from 6822 active GP practices. Assuming 25% of these GP practices will engage, we will contact all GP practices in England spread across 135 Clinical Commissioning Groups. TRIAL STATUS Protocol version 2.0, dated 13 January 2021. Implementation is ongoing. The implementation period started on 10 November 2020 and will end on 10 March 2021. TRIAL REGISTRATION This trial was registered in the ISRCTN registry ( isrctn.com/ ISRCTN14602359 ) on 12 August 2020. FULL PROTOCOL The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2021,"Using behaviour change techniques, it helps users think through and adopt better home hygiene habits and find ways to solve any barriers, providing personalised goal setting and tailored advice that fits users' personal circumstances and problem solving to overcome barriers.","['Protocol version 2.0, dated 13 January 2021', 'Setting', '12 August 2020', 'All patients aged 16 years and over who were granted access by participating GP practices', '2015): 11.1 million respondents from 6822 active GP practices']","['digital behaviour change intervention', 'Comparator', 'usual care arm will receive current standard management']","['effects of implementing Germ Defence on prevalence of all respiratory tract infection diagnoses', '1) incidence of COVID-19 diagnoses 2) incidence of COVID-19 symptom presentation 3) incidence of gastrointestinal infections 4) number of primary care consultations 5) antibiotic usage 6) hospital admissions 7) uptake of GP practices disseminating Germ Defence to their patients 8) usage of the Germ Defence website']","[{'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018173', 'cui_str': 'Grants'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0729555', 'cui_str': 'Infection of digestive system'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205221', 'cui_str': 'Disseminated'}]",6822.0,0.260686,"Using behaviour change techniques, it helps users think through and adopt better home hygiene habits and find ways to solve any barriers, providing personalised goal setting and tailored advice that fits users' personal circumstances and problem solving to overcome barriers.","[{'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Horwood', 'Affiliation': 'National Institute for Health Research, Applied Research Collaboration West (NIHR ARC West) University Hospitals Bristol and Weston NHS Foundation Trust, 9th Floor, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK. j.horwood@bristol.ac.uk.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Chalder', 'Affiliation': 'Centre for Academic Primary Care (CAPC), Bristol Medical School, Population Health Sciences, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Ainsworth', 'Affiliation': 'Department of Psychology, University of Bath, Bath, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Denison-Day', 'Affiliation': 'School of Psychology, University of Southampton, Southampton, UK.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'de Vocht', 'Affiliation': 'National Institute for Health Research, Applied Research Collaboration West (NIHR ARC West) University Hospitals Bristol and Weston NHS Foundation Trust, 9th Floor, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK.'}, {'ForeName': 'Martha M C', 'Initials': 'MMC', 'LastName': 'Elwenspoek', 'Affiliation': 'National Institute for Health Research, Applied Research Collaboration West (NIHR ARC West) University Hospitals Bristol and Weston NHS Foundation Trust, 9th Floor, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK.'}, {'ForeName': 'Pippa', 'Initials': 'P', 'LastName': 'Craggs', 'Affiliation': 'National Institute for Health Research, Applied Research Collaboration West (NIHR ARC West) University Hospitals Bristol and Weston NHS Foundation Trust, 9th Floor, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Denholm', 'Affiliation': 'National Institute for Health Research, Applied Research Collaboration West (NIHR ARC West) University Hospitals Bristol and Weston NHS Foundation Trust, 9th Floor, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Sterne', 'Affiliation': 'Centre for Academic Primary Care (CAPC), Bristol Medical School, Population Health Sciences, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Rice', 'Affiliation': ', Stoke Gifford, UK.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Miller', 'Affiliation': 'School of Psychology, University of Southampton, Southampton, UK.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Stuart', 'Affiliation': 'Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Merlin', 'Initials': 'M', 'LastName': 'Willcox', 'Affiliation': 'Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Macleod', 'Affiliation': 'National Institute for Health Research, Applied Research Collaboration West (NIHR ARC West) University Hospitals Bristol and Weston NHS Foundation Trust, 9th Floor, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gullford', 'Affiliation': ""School of Population Health and Environmental Sciences at King's College London, London, UK.""}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Morton', 'Affiliation': 'School of Psychology, University of Southampton, Southampton, UK.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Towler', 'Affiliation': 'School of Psychology, University of Southampton, Southampton, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Francis', 'Affiliation': 'Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Amlôt', 'Affiliation': 'Behavioural Science Team, Emergency Response Department, Public Health England, Salisbury, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Yardley', 'Affiliation': 'National Institute for Health Research, Applied Research Collaboration West (NIHR ARC West) University Hospitals Bristol and Weston NHS Foundation Trust, 9th Floor, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK.'}]",Trials,['10.1186/s13063-021-05188-7'] 3180,33836819,A review of flash glucose monitoring in type 2 diabetes.,"BACKGROUND Continuous glucose monitoring systems are increasingly being adopted as an alternative to self-monitoring of blood glucose (SMBG) by persons with diabetes mellitus receiving insulin therapy. MAIN BODY The FreeStyle Libre flash glucose monitoring system (Abbott Diabetes Care, Witney, United Kingdom) consists of a factory-calibrated sensor worn on the back of the arm which measures glucose levels in the interstitial fluid every minute and stores the reading automatically every 15 min. Swiping the reader device over the sensor retrieves stored data and displays current interstitial glucose levels, a glucose trend arrow, and a graph of glucose readings over the preceding 8 h. In patients with type 2 diabetes (T2D) receiving insulin therapy, pivotal efficacy data were provided by the 6-month REPLACE randomized controlled trial (RCT) and 6-month extension study. Compared to SMBG, the flash system significantly reduced the time spent in hypoglycemia and frequency of hypoglycemic events, although no significant change was observed in glycosylated hemoglobin (HbA1c) levels. Subsequent RCTs and real-world chart review studies have since shown that flash glucose monitoring significantly reduces HbA1c from baseline. Real-world studies in both type 1 diabetes or T2D populations also showed that flash glucose monitoring improved glycemic control. Higher (versus lower) scanning frequency was associated with significantly greater reductions in HbA1c and significant improvements in other measures such as time spent in hypoglycemia, time spent in hyperglycemia, and time in range. Additional benefits associated with flash glucose monitoring versus SMBG include reductions in acute diabetes events, all-cause hospitalizations and hospitalized ketoacidosis episodes; improved well-being and decreased disease burden; and greater treatment satisfaction. CONCLUSION T2D patients who use flash glucose monitoring might expect to achieve significant improvement in HbA1c and glycemic parameters and several associated benefits.",2021,"Higher (versus lower) scanning frequency was associated with significantly greater reductions in HbA1c and significant improvements in other measures such as time spent in hypoglycemia, time spent in hyperglycemia, and time in range.","['persons with diabetes mellitus receiving insulin therapy', 'type 2 diabetes', 'T2D patients who use', 'patients with type 2 diabetes (T2D) receiving']","['flash glucose monitoring versus SMBG', 'insulin therapy', 'flash glucose monitoring']","['time spent in hypoglycemia and frequency of hypoglycemic events', 'HbA1c and glycemic parameters', 'glycosylated hemoglobin (HbA1c) levels', 'glycemic control', 'time spent in hypoglycemia, time spent in hyperglycemia, and time in range']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}]",,0.0359883,"Higher (versus lower) scanning frequency was associated with significantly greater reductions in HbA1c and significant improvements in other measures such as time spent in hypoglycemia, time spent in hyperglycemia, and time in range.","[{'ForeName': 'Marcio', 'Initials': 'M', 'LastName': 'Krakauer', 'Affiliation': 'Department of Technology (Coordinator) SBD-Brazilian Diabetes Society, Science Valley Research Center, Liga de Diabetes, ABC Medical School, Avenida 12 de Outubro 286, Santo André, SP, CEP 09030-640, Brazil. marcio@nidomater.com.br.'}, {'ForeName': 'Jose Fernando', 'Initials': 'JF', 'LastName': 'Botero', 'Affiliation': 'Clínica Integral de Diabetes-CLID, Medellín, Colombia.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Lavalle-González', 'Affiliation': 'Servicio de Endocrinología, Hospital Universitario Dr José e Gonzalez, UANL, Monterrey, México.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Proietti', 'Affiliation': 'Institute of Diabetes and Applied Technology (IDTA), Buenos Aires, Argentina.'}, {'ForeName': 'Douglas Eugenio', 'Initials': 'DE', 'LastName': 'Barbieri', 'Affiliation': 'Abbott Diabetes Care, Sao Paulo, Brazil.'}]",Diabetology & metabolic syndrome,['10.1186/s13098-021-00654-3'] 3181,33836817,Effects of intermittently scanned continuous glucose monitoring on blood glucose control and the production of urinary ketone bodies in pregestational diabetes mellitus.,"OBJECTIVE To investigate the effects of intermittently scanned continuous glucose monitoring (isCGM) on blood glucose control, clinical value of blood glucose monitoring and production of urinary ketone bodies in pregestational diabetes mellitus. METHOD A total of 124 patients with pregestational diabetes mellitus at 12-14 weeks of gestation admitted to the gestational diabetes clinic of our hospital from December 2016 to December 2018 were selected and randomly divided into two groups. Sixty patients adopted self-monitoring of blood glucose (SMBG) were taken as the control group, and the other 64 patients adopted isCGM system by wearing the device for 14 days. Blood sugar control, glycosylated albumin level, ketone production in urine, the maximum and minimum of blood sugar value measured by different monitoring methods and their occurrence time were observed in the two groups. RESULT (1) No statistically significant differences were found between the groups in terms of maternal age, gestational age at first visit, family history, duration of diabetes, education level, total insulin dose, chronic hypertension, abortion history, nulliparity, assisted reproductive technology, history of macrosomia childbirth, pre-pregnancy BMI, and overweight (%) at the first visit and hypoglycemia, (2) the value of Glycated Albumin was lower in the CGM group compared to the control group at 2ed weeks (14.6 ± 2.2 vs. 16.8 ± 2.7, p < 0.001). The women in the CGM group spent increased time in the recommended glucose control target range of 3.5-7.8 mmol/L (69 ± 10% vs. 62 ± 11%, p < 0.001) and reduced time above target compared with those in the control group at 2 weeks (25 ± 7% vs. 31 ± 8%, p < 0.001). In the second week of the study, the positive rate of urinary ketone body in isCGM group was lower than that in the control group (42 ± 5 vs. 54 ± 5, p < 0.001), and (3) the minimum blood glucose of 31.2% (20/64) cases in isCGM group appeared during 0:00-2:59 at night, and 26.6% (17/64) cases appeared during 3:00-5:59 at night. The minimum values of 40.0% (24/60) cases in the control group appeared within the 30 min before lunch, 23.3% (14/60) within the 30 min before breakfast, and 11.7% (7/60) within the 30 min before dinner. The cases of minimum of blood sugar before meals accounted for 75% of all the minimum values, and the cases of minimum at night only accounted for 8.3%. CONCLUSION Intermittently scanned continuous glucose monitoring can reduce hyperglycemia exposure and ketone body formation in pregestational diabetes mellitus. In addition, isCGM is better than SMBG in detecting nocturnal hypoglycemia.",2021,"No statistically significant differences were found between the groups in terms of maternal age, gestational age at first visit, family history, duration of diabetes, education level, total insulin dose, chronic hypertension, abortion history, nulliparity, assisted reproductive technology, history of macrosomia childbirth, pre-pregnancy BMI, and overweight (%) at the first visit and hypoglycemia,","['pregestational diabetes mellitus', '124 patients with pregestational diabetes mellitus at 12-14\xa0weeks of gestation admitted to the gestational diabetes clinic of our hospital from December 2016 to December 2018']","['isCGM', 'intermittently scanned continuous glucose monitoring', 'SMBG', 'intermittently scanned continuous glucose monitoring (isCGM']","['minimum blood glucose', 'reduced time above target', 'Blood sugar control, glycosylated albumin level, ketone production in urine, the maximum and minimum of blood sugar value', 'nocturnal hypoglycemia', 'maternal age, gestational age at first visit, family history, duration of diabetes, education level, total insulin dose, chronic hypertension, abortion history, nulliparity, assisted reproductive technology, history of macrosomia childbirth, pre-pregnancy BMI, and overweight (%) at the first visit and hypoglycemia', 'hyperglycemia exposure and ketone body formation', 'value of Glycated Albumin', 'blood glucose control', 'self-monitoring of blood glucose (SMBG', 'blood sugar before meals', 'positive rate of urinary ketone body', 'urinary ketone bodies', 'blood glucose control, clinical value of blood glucose monitoring and production of urinary ketone bodies']","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0201838', 'cui_str': 'Albumin measurement'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0342315', 'cui_str': 'Nocturnal hypoglycemia'}, {'cui': 'C0024915', 'cui_str': 'Maternal age'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0241889', 'cui_str': 'Family history of clinical finding'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0000790', 'cui_str': 'History of pregnancy with abortive outcome'}, {'cui': 'C0028641', 'cui_str': 'Nulliparity'}, {'cui': 'C0872104', 'cui_str': 'Assisted reproductive technology'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0158915', 'cui_str': 'Exceptionally large at birth'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0022631', 'cui_str': 'Ketone body'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C1550738', 'cui_str': 'Before food'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]",124.0,0.011996,"No statistically significant differences were found between the groups in terms of maternal age, gestational age at first visit, family history, duration of diabetes, education level, total insulin dose, chronic hypertension, abortion history, nulliparity, assisted reproductive technology, history of macrosomia childbirth, pre-pregnancy BMI, and overweight (%) at the first visit and hypoglycemia,","[{'ForeName': 'Shu-Ying', 'Initials': 'SY', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, Tianjin Xiqing Hospital, Tianjin, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': 'NHC Key Laboratory of Hormones and Development (Tianjin Medical University), Tianjin Key Laboratory of Metabolic Diseases, Tianjin Medical University Chu Hsien-I Memorial Hospital & Tianjin Institute of Endocrinology, Tianjin, 300134, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'NHC Key Laboratory of Hormones and Development (Tianjin Medical University), Tianjin Key Laboratory of Metabolic Diseases, Tianjin Medical University Chu Hsien-I Memorial Hospital & Tianjin Institute of Endocrinology, Tianjin, 300134, China.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'NHC Key Laboratory of Hormones and Development (Tianjin Medical University), Tianjin Key Laboratory of Metabolic Diseases, Tianjin Medical University Chu Hsien-I Memorial Hospital & Tianjin Institute of Endocrinology, Tianjin, 300134, China.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Zhou', 'Affiliation': 'NHC Key Laboratory of Hormones and Development (Tianjin Medical University), Tianjin Key Laboratory of Metabolic Diseases, Tianjin Medical University Chu Hsien-I Memorial Hospital & Tianjin Institute of Endocrinology, Tianjin, 300134, China.'}, {'ForeName': 'Li-Rong', 'Initials': 'LR', 'LastName': 'Sun', 'Affiliation': 'NHC Key Laboratory of Hormones and Development (Tianjin Medical University), Tianjin Key Laboratory of Metabolic Diseases, Tianjin Medical University Chu Hsien-I Memorial Hospital & Tianjin Institute of Endocrinology, Tianjin, 300134, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'NHC Key Laboratory of Hormones and Development (Tianjin Medical University), Tianjin Key Laboratory of Metabolic Diseases, Tianjin Medical University Chu Hsien-I Memorial Hospital & Tianjin Institute of Endocrinology, Tianjin, 300134, China.'}, {'ForeName': 'Li-Ming', 'Initials': 'LM', 'LastName': 'Chen', 'Affiliation': 'NHC Key Laboratory of Hormones and Development (Tianjin Medical University), Tianjin Key Laboratory of Metabolic Diseases, Tianjin Medical University Chu Hsien-I Memorial Hospital & Tianjin Institute of Endocrinology, Tianjin, 300134, China. xfx22081@vip.163.com.'}]",Diabetology & metabolic syndrome,['10.1186/s13098-021-00657-0'] 3182,33836736,Use of 360° virtual reality video in medical obstetrical education: a quasi-experimental design.,"BACKGROUND Video-based teaching has been part of medical education for some time but 360° videos using a virtual reality (VR) device are a new medium that offer extended possibilities. We investigated whether adding a 360° VR video to the internship curriculum leads to an improvement of long-term recall of specific knowledge on a gentle Caesarean Sections (gCS) and on general obstetric knowledge. METHODS Two weeks prior to their Obstetrics and Gynaecology (O&G) internship, medical students were divided in teaching groups, that did or did not have access to a VR-video of a gCS. Six weeks after their O&G internship, potentially having observed one or multiple real-life CSs, knowledge on the gCS was assessed with an open questionnaire, and knowledge on general obstetrics with a multiple-choice questionnaire. Furthermore we assessed experienced anxiety during in-person attendance of CSs, and we asked whether the interns would have wanted to attend more CSs in-person. The 360° VR video group was questioned about their experience directly after they watched the video. We used linear regression analyses to determine significant effects on outcomes. RESULTS A total of 89 medical students participated, 41 in the 360° VR video group and 48 in the conventional study group. Watching the 360° VR video did not result in a difference in either specific or general knowledge retention between the intervention group and the conventional study group. This was both true for the grade received for the internship, the open-ended questions as well as the multiple-choice questions and this did not change after adjustment for confounding factors. Still, 83.4% of the 360° VR video-group reported that more videos should be used in training to prepare for surgical procedures. In the 360° VR video-group 56.7% reported side effects like nausea or dizziness. After adjustment for the number of attended CSs during the practical internship, students in the 360° VR video-group stated less often (p = 0.04) that they would have liked to attend more CSs in-person as compared to the conventional study group. CONCLUSION Even though the use of 360° VR video did not increase knowledge, it did offer a potential alternative for attending a CS in-person and a new way to prepare the students for their first operating room experiences.",2021,Watching the 360° VR video did not result in a difference in either specific or general knowledge retention between the intervention group and the conventional study group.,"['89 medical students participated, 41 in the 360° VR video group and 48 in the conventional study group', '360° virtual reality video in medical obstetrical education']","['Obstetrics and Gynaecology (O&G) internship, medical students were divided in teaching groups, that did or did not have access to a VR-video of a gCS', '360° VR video to the internship curriculum leads to an improvement of long-term recall of specific knowledge on a gentle Caesarean Sections (gCS']","['side effects like nausea or dizziness', 'specific or general knowledge retention']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C1274104', 'cui_str': 'Obstetrics and gynecology'}, {'cui': 'C0237690', 'cui_str': 'Internship'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",89.0,0.00878942,Watching the 360° VR video did not result in a difference in either specific or general knowledge retention between the intervention group and the conventional study group.,"[{'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Arents', 'Affiliation': 'Spaarne Gasthuis Academie, Spaarne Gasthuis Hospital, SpaarnePoort 1, 2134, TM, Hoofddorp, the Netherlands.'}, {'ForeName': 'Pieter C M', 'Initials': 'PCM', 'LastName': 'de Groot', 'Affiliation': 'Department of Gynaecology, Spaarne Gasthuis Hospital, Hoofddorp, the Netherlands.'}, {'ForeName': 'Veerle M D', 'Initials': 'VMD', 'LastName': 'Struben', 'Affiliation': 'Spaarne Gasthuis Academie, Spaarne Gasthuis Hospital, SpaarnePoort 1, 2134, TM, Hoofddorp, the Netherlands.'}, {'ForeName': 'Karlijn J', 'Initials': 'KJ', 'LastName': 'van Stralen', 'Affiliation': 'Spaarne Gasthuis Academie, Spaarne Gasthuis Hospital, SpaarnePoort 1, 2134, TM, Hoofddorp, the Netherlands. kvanstralen@spaarnegasthuis.nl.'}]",BMC medical education,['10.1186/s12909-021-02628-5'] 3183,33836723,"Effects of improved information and volunteer support on segregation of solid waste at the household level in urban settings in Madhya Pradesh, India (I-MISS): protocol of a cluster randomized controlled trial.","BACKGROUND Segregation of household waste at the source is an effective and sustainable strategy for management of municipal waste. However, household segregation levels remain insufficient as waste management approaches are mostly top down and lack local support. The realisation and recognition of effective, improved and adequate waste management may be one of the vital drivers for attaining environmental protection and improved health and well-being. The presence of a local level motivator may promote household waste segregation and ultimately pro-environmental behaviour. The present cluster randomized control trial aims to understand if volunteer based information on waste segregation (I-MISS) can effectively promote increased waste segregation practices at the household level when compared with existing routine waste segregation information in an urban Indian setting. METHODS This paper describes the protocol of an 18 month two-group parallel,cluster randomised controlled trialin the urban setting of Ujjain, Madhya Pradesh, India. Randomization will be conducted at ward level, which is the last administrative unit of the municipality. The study will recruit 425 households in intervention and control groups. Assessments will be performed at baseline (0 months), midline (6 months), end line (12 months) and post intervention (18 months). The primary outcome will be the comparison of change in proportion of households practicing waste segregation and change in proportion of mis-sorted waste across the study period between the intervention and control groups as assessed by pick analysis. Intention to treat analysis will be conducted. Written informed consent will be obtained from all participants. DISCUSSION The present study is designed to study whether an external motivator, a volunteer selected from the participating community and empowered with adequate training, could disseminate waste segregation information to their community, thus promoting household waste segregation and ultimately pro-environmental behaviour. The study envisages that the volunteers could link waste management service providers and the community, give a local perspective to waste management, and help to change community habits through information, constant communication and feedback. TRIAL REGISTRATION The study is registered prospectively with Indian Council of Medical Research- Clinical Trial Registry of India ( CTRI/2020/03/024278 ).",2021,"The present cluster randomized control trial aims to understand if volunteer based information on waste segregation (I-MISS) can effectively promote increased waste segregation practices at the household level when compared with existing routine waste segregation information in an urban Indian setting. ","['segregation of solid waste at the household level in urban settings in Madhya Pradesh, India (I-MISS', '18\u2009month two-group parallel,cluster randomised controlled trialin the urban setting of Ujjain, Madhya Pradesh, India', '425 households in intervention and control groups', 'Indian Council of Medical Research', 'volunteer selected from the participating community and empowered with adequate training']",[],['comparison of change in proportion of households practicing waste segregation and\xa0change in proportion of mis-sorted waste across the study period'],"[{'cui': 'C0080141', 'cui_str': 'Racial Segregation'}, {'cui': 'C1550151', 'cui_str': 'Solid Waste'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3844105', 'cui_str': '425'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],"[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0080141', 'cui_str': 'Racial Segregation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",425.0,0.0951783,"The present cluster randomized control trial aims to understand if volunteer based information on waste segregation (I-MISS) can effectively promote increased waste segregation practices at the household level when compared with existing routine waste segregation information in an urban Indian setting. ","[{'ForeName': 'Madhanraj', 'Initials': 'M', 'LastName': 'Kalyanasundaram', 'Affiliation': 'Division of Environmental Health and Epidemiology, ICMR - National Institute for Research in Environmental Health, Bhopal, 462 030, India.'}, {'ForeName': 'Yogesh', 'Initials': 'Y', 'LastName': 'Sabde', 'Affiliation': 'Division of Environmental Health and Epidemiology, ICMR - National Institute for Research in Environmental Health, Bhopal, 462 030, India.'}, {'ForeName': 'Kristi Sidney', 'Initials': 'KS', 'LastName': 'Annerstedt', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, SE-171 77, Stockholm, Sweden.'}, {'ForeName': 'Surya', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Division of Environmental Monitoring and Exposure Assessment (Water & Soil), ICMR - National Institute for Research in Environmental Health, Bhopal, 462 030, India.'}, {'ForeName': 'Krushna Chandra', 'Initials': 'KC', 'LastName': 'Sahoo', 'Affiliation': 'ICMR- Regional Medical Research Centre, Bhubaneshwar, 751023, India.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Parashar', 'Affiliation': 'Department of Public Health and Environment, RD Gardi Medical College, Ujjain, 456006, India.'}, {'ForeName': 'Manju', 'Initials': 'M', 'LastName': 'Purohit', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, SE-171 77, Stockholm, Sweden.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Pathak', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, SE-171 77, Stockholm, Sweden.'}, {'ForeName': 'Cecilia Stålsby', 'Initials': 'CS', 'LastName': 'Lundborg', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, SE-171 77, Stockholm, Sweden.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Rousta', 'Affiliation': 'Department of Resource Recovery and Building Technology, University of Boras, 50190, Boras, Sweden.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Bolton', 'Affiliation': 'Department of Resource Recovery and Building Technology, University of Boras, 50190, Boras, Sweden.'}, {'ForeName': 'Salla', 'Initials': 'S', 'LastName': 'Atkins', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, SE-171 77, Stockholm, Sweden.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Diwan', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, SE-171 77, Stockholm, Sweden. vishaldiwan@hotmail.com.'}]",BMC public health,['10.1186/s12889-021-10693-0'] 3184,33832167,Study for cerebral central network mechanism of acupuncture stimulation quantity based on changes of cerebral functional connection of fMRI.,"BACKGROUND Ischemic stroke is a major chronic noninfectious disease that seriously endangers health. Acupuncture is effective for ischemic stroke and less adverse reactions. However, there is not enough clinical trial data and solid evidence could confirm how acupuncture work to cerebral functional connectivity changes, and whether the changes is related to the different stimulation quantity. DESIGN This is a multicenter, central-randomized, controlled, double-blind, noninferiority, 2 factors and 3 levels orthogonal clinical trial. A total of 100 participants with ischemic stroke aged from 40 to 80 were randomized into experimental group and control group, the experimental group was divided into 9 groups (A1-A9) according to different factors or levels, and each group have 10 participants. The whole study period is 17 days, including 1 week for baseline observation, 3 days treatment and observation, and 1 week follow-up. Primary outcome is the fMRI based on blood oxygenation level dependent. Secondary outcomes included National Institute of Health Stroke Scale, Modified Barthel Index, Brunnstrom stroke recovery, stroke Chinese medicine symptom. Clinical assessments will be evaluated at before and the 0 hour, 24 hours, 36 hours after treatment, and 1 week follow-up. The primary outcome of the postacupuncture effect were investigated by paired T-test, and the continuous outcome variables will be analyzed with univariate repetitive measurement deviation analysis. Adverse events will be noted and recorded for the safety evaluation. CONCLUSION The purpose of this study was to evaluate the central mechanism of acupuncture stimulation quantity using time and frequency as control conditions. This study will provide reasonable stimulation parameters and strong mechanism evidence of cerebral central network for the use of acupuncture for ischemic stroke. CHICTR REGISTRATION NUMBER ChiCTR1900023169. Registered 15 May 2019.",2021,Acupuncture is effective for ischemic stroke and less adverse reactions.,['100 participants with ischemic stroke aged from 40 to 80'],"['acupuncture', 'Acupuncture', 'acupuncture stimulation quantity']","['fMRI based on blood oxygenation level dependent', 'cerebral functional connection of fMRI', 'Adverse events', 'postacupuncture effect', 'National Institute of Health Stroke Scale, Modified Barthel Index, Brunnstrom stroke recovery, stroke Chinese medicine symptom']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}]","[{'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",100.0,0.395511,Acupuncture is effective for ischemic stroke and less adverse reactions.,"[{'ForeName': 'Yihao', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Yunnan University of Traditional Chinese Medicine.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'The First Clinical Medical College of Yunnan University of Traditional Chinese Medicine, Kunming.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Qingdao Central Hospital, Qingdao, China.'}, {'ForeName': 'Xuelian', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Yunnan University of Traditional Chinese Medicine.'}, {'ForeName': 'Anhong', 'Initials': 'A', 'LastName': 'Dai', 'Affiliation': 'Yunnan University of Traditional Chinese Medicine.'}, {'ForeName': 'Sifeng', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': 'The First Clinical Medical College of Yunnan University of Traditional Chinese Medicine, Kunming.'}, {'ForeName': 'Chunhong', 'Initials': 'C', 'LastName': 'Luo', 'Affiliation': 'Yunnan University of Traditional Chinese Medicine.'}, {'ForeName': 'Zhilin', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Yunnan University of Traditional Chinese Medicine.'}, {'ForeName': 'Gan', 'Initials': 'G', 'LastName': 'Huang', 'Affiliation': 'Yunnan University of Traditional Chinese Medicine.'}]",Medicine,['10.1097/MD.0000000000025480'] 3185,33832145,"The synergistic effects of applying pulsed radiofrequency lesioning of the suprascapular nerve plus physical therapy on pain and function in patients with adhesive capsulitis: A protocol of a prospective, randomized, controlled trial.","BACKGROUND To our knowledge, there have been no published clinical trials to assess the synergistic effects of applying pulsed radiofrequency (PRF) stimulation of the suprascapular nerve (SSN) plus physical therapy on pain and function in patients with adhesive capsulitis. Therefore, we will conduct this present randomized, double-blind study to evaluate the synergistic effects of applying PRF stimulation of the SSN plus physical therapy on pain and function in patients with adhesive capsulitis. METHODS The study protocol is a randomized, controlled, double-blind design. Recruitment will be started in March 2021 and completed in October 2022. The treating surgeon will assess 90 patients for eligibility. The study protocol was approved through Institutional Review Board in the People's Hospital of Beilun district of Ningbo. Each patient will be randomized into 3 treatment groups, receiving PRF stimulation of the SSN or physical therapy or both of them. After baseline examination, all patients will be given a full explanation of the treatment protocol and will be required to sign a written informed consent for study participation and for publication of the results. All the data collectors, surgeons, statistical analysts, as well as result assessors are not aware of grouping assignment. The outcomes include Constant score, visual analog scale score, range of motion, and strength. RESULTS This protocol will provide a reliable theoretical basis for the following research. CONCLUSION It is assumed that there will be a remarkable difference in postoperative outcomes between the intervention and control groups. TRIAL REGISTRATION NUMBER 10.17605/OSF.IO/PZ9ES.",2021,"All the data collectors, surgeons, statistical analysts, as well as result assessors are not aware of grouping assignment.","['90 patients for eligibility', 'patients with adhesive capsulitis', ""People's Hospital of Beilun district of Ningbo""]","['pulsed radiofrequency lesioning of the suprascapular nerve plus physical therapy', 'SSN plus physical therapy', 'pulsed radiofrequency (PRF) stimulation of the suprascapular nerve (SSN) plus physical therapy', 'PRF stimulation of the SSN or physical therapy']","['Constant score, visual analog scale score, range of motion, and strength', 'pain and function', 'postoperative outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0158300', 'cui_str': 'Capsulitis, Adhesive'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0228878', 'cui_str': 'Structure of suprascapular nerve'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.254867,"All the data collectors, surgeons, statistical analysts, as well as result assessors are not aware of grouping assignment.","[{'ForeName': 'Weifeng', 'Initials': 'W', 'LastName': 'Liao', 'Affiliation': 'Department of Spine Surgery, The Orthopedics Hospital of Traditional Chinese Medicine Zhuzhou City.'}, {'ForeName': 'Xinning', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Spine Surgery, The Orthopedics Hospital of Traditional Chinese Medicine Zhuzhou City.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Du', 'Affiliation': 'Department of Spine Surgery, The Orthopedics Hospital of Traditional Chinese Medicine Zhuzhou City.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Long', 'Affiliation': 'Department of Joint Surgery, Zhuzhou Central Hospital, Zhuzhou, Hunan, China.'}]",Medicine,['10.1097/MD.0000000000025431'] 3186,33832143,Study on the effect of education for insulin injection in diabetic patients with new simulation tools.,"BACKGROUND Insulin is an essential therapy for treating diabetes, but many patients lack standard insulin injection skills. PURPOSE We developed a standard training procedure based on a new simulation tool. Then we conducted a study to investigate the effect of this standard training on the ability of diabetic patients to inject themselves with insulin. METHODS After follow-up, a total of 120 patients with diabetes mellitus were included. These patients needed insulin therapy depending on their condition and had not previously learned insulin injection. We randomly divided them into the intervention group (60 cases) and the control group (60 cases). The control group was trained on insulin injection before being discharged according to the traditional method, and the intervention group was trained based on an improved simulation tool. All participants were trained as individuals or groups. Finally, we evaluated the learning effects of both groups. RESULTS The time spent at the training stage in the intervention group was shorter than the control group. We found that after applying simulation devices to mimic operations, the learning time for patients was reduced.The first subcutaneous injection success rate was 73.33% in the intervention group, which was significantly higher than that in the control group by 46.67%. The score of the first subcutaneous injection and pre-discharge score in the test group was significantly higher than that of the control group. One month later, the score for injection skills in the 2 groups was higher than that before discharge, and the score in the trial group was still higher than that in the control group. The incidence of subcutaneous fat hyperplasia in the trial group was lower than that in the control group (3.3% vs 15%, P < .05). Moreover, the incidence of hypoglycemia (16.7% vs. 26.7%) was higher in the control group, but the difference was not statistically significant (P = .184). CONCLUSIONS/IMPLICATIONS FOR PRACTICE After applying simulation tools plus operating video and guideline as the standard procedure to train diabetic patients on insulin injection, all patients had a good grasp of using the insulin injection technique. This education method is safe, efficient, and worth promoting worldly.",2021,"The incidence of subcutaneous fat hyperplasia in the trial group was lower than that in the control group (3.3% vs 15%, P < .05).","['diabetic patients with new simulation tools', 'diabetic patients to inject themselves with insulin', '120 patients with diabetes mellitus']","['insulin injection', 'standard training']","['time spent', 'incidence of subcutaneous fat hyperplasia', 'incidence of hypoglycemia', 'score for injection skills', 'subcutaneous injection success rate', 'score of the first subcutaneous injection and pre-discharge score']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",120.0,0.0114323,"The incidence of subcutaneous fat hyperplasia in the trial group was lower than that in the control group (3.3% vs 15%, P < .05).","[{'ForeName': 'Kaiyong', 'Initials': 'K', 'LastName': 'Liang', 'Affiliation': 'Department of Endocrinology and Metabolism, Wuzhou Worker Hospital, Gao Di Road.'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Xie', 'Affiliation': ""Department of Neurology, the people's hospital, Sanlong Avenue, Changzhou District, Wuzhou, Guangxi, China.""}, {'ForeName': 'Jieping', 'Initials': 'J', 'LastName': 'Nie', 'Affiliation': 'Department of Endocrinology and Metabolism, Wuzhou Worker Hospital, Gao Di Road.'}, {'ForeName': 'Jieqing', 'Initials': 'J', 'LastName': 'Deng', 'Affiliation': 'Department of Endocrinology and Metabolism, Wuzhou Worker Hospital, Gao Di Road.'}]",Medicine,['10.1097/MD.0000000000025424'] 3187,33832089,"Effectiveness of thoracic kinesio taping on respiratory function and muscle strength in patients with chronic obstructive pulmonary disease: A protocol of randomized, double-blind placebo-controlled trial.","BACKGROUND To our knowledge, only 1 study has investigated the effects of kinesio taping (KT) on pulmonary function and functional capacity of patients with chronic obstructive pulmonary disease (COPD). Therefore, there is still a lack of high-quality evidence to prove the effectiveness of KT for COPD patients. Our purpose was to investigate the effect of KT on respiratory function and muscle strength in the COPD patients who were in stable condition. METHODS This research project has been received ethical approval from the Medical Research and Ethics Committee in Affiliated Nanhua Hospital, University of South China. This work is a part of a comprehensive research project to assess and provide intervention that potentially improves respiratory function and quality of life among patients with COPD. Participants recruited into the study need to fulfill the following criteria: clinical diagnosis of COPD and symptoms indicative of exacerbation; spontaneous breathing on hospital admission; and physiotherapy since the first day of hospitalization. Patients will be assigned at random to the COPD medical treatment + KT (Group 1), or the COPD medical treatment alone (Group 2). The outcome measures are pulmonary function and respiratory muscle strength. The level of statistical significance is set as P < .05. RESULTS This protocol will provide a reliable theoretical basis for the following research. CONCLUSIONS It was hypothesized that thoracic KT could significantly change pulmonary function and functional capacity in patients with COPD. TRIAL REGISTRATION This study protocol was registered in Research Registry (researchregistry6632).",2021,"Patients will be assigned at random to the COPD medical treatment + KT (Group 1), or the COPD medical treatment alone (Group 2).","['patients with chronic obstructive pulmonary disease', 'COPD patients', 'COPD patients who were in stable condition', 'patients with COPD', 'patients with chronic obstructive pulmonary disease (COPD', 'Participants recruited into the study need to fulfill the following criteria: clinical diagnosis of COPD and symptoms indicative of exacerbation; spontaneous breathing on hospital admission; and physiotherapy since the first day of hospitalization']","['kinesio taping (KT', 'placebo', 'KT', 'thoracic kinesio taping', 'COPD medical treatment alone', 'COPD medical treatment + KT']","['pulmonary function and functional capacity', 'respiratory function and quality of life', 'respiratory function and muscle strength', 'pulmonary function and respiratory muscle strength']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}]",,0.240282,"Patients will be assigned at random to the COPD medical treatment + KT (Group 1), or the COPD medical treatment alone (Group 2).","[{'ForeName': 'Renfeng', 'Initials': 'R', 'LastName': 'Zeng', 'Affiliation': 'Pulmonary and Critical Care Medicine, Affiliated Nanhua Hospital, University of South China, HengYang, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Tian', 'Affiliation': ''}, {'ForeName': 'Zhike', 'Initials': 'Z', 'LastName': 'Xiao', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000025269'] 3188,33832081,Effectiveness and safety of repetitive transcranial magnetic stimulation for the treatment of morphine dependence: A retrospective study.,"ABSTRACT Morphine dependence (MD) is a very common complication because of the chronic morphine consumption. Studies suggest that repetitive transcranial magnetic stimulation (rTMS) can be used for the treatment of MD. However, there is still lacking evidence to support rTMS for MD. Thus, this retrospective study aimed to investigate the effectiveness and safety of rTMS for patients with MD.In this retrosepctive study, a total of 100 patients with MD were included, and they were divided into a rTMS group (n = 50), and a control group (n = 50). All patients in both groups received occupational therapy. In addition, patients in the rTMS group received rTMS. All patients in both groups received a total of 8 weeks treatment. The outcomes comprised of morphine craving intensity, depression, anxiety, and sleep quality, which were appraised by Visual Analogue Scale (VAS), Self-Rating Depression Scale (SDS), Self-Rating Anxiety Scale (SAS), and Pittsburgh Sleep Quality Index (PSQI), respectively. In addition, treatment-related adverse events were also considered for assessment.After 8 weeks treatment, patients in the rTMS group exerted better benefits in improving VAS (P < .01), SDS (P < .01), SAS (P < .01), and PSQI (P < .01), than patients in the control group. In addition, this study did not identify treatment-related adverse events in both groups.The findings of this study showed that rTMS treatment showed promising effectiveness on patients with MD. However, future studies should focus on warranting the present findings.",2021,"After 8 weeks treatment, patients in the rTMS group exerted better benefits in improving VAS (P < .01), SDS (P < .01), SAS (P < .01), and PSQI (P < .01), than patients in the control group.","['patients with MD', 'morphine dependence', 'patients with MD.In this retrosepctive study, a total of 100 patients with MD']","['repetitive transcranial magnetic stimulation (rTMS', 'rTMS', 'repetitive transcranial magnetic stimulation', 'occupational therapy']","['SDS', 'VAS', 'PSQI', 'SAS', 'morphine craving intensity, depression, anxiety, and sleep quality, which were appraised by Visual Analogue Scale (VAS), Self-Rating Depression Scale (SDS), Self-Rating Anxiety Scale (SAS), and Pittsburgh Sleep Quality Index (PSQI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026552', 'cui_str': 'Morphine dependence'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",100.0,0.00635418,"After 8 weeks treatment, patients in the rTMS group exerted better benefits in improving VAS (P < .01), SDS (P < .01), SAS (P < .01), and PSQI (P < .01), than patients in the control group.","[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Neurology.'}, {'ForeName': 'Guang-Fu', 'Initials': 'GF', 'LastName': 'Song', 'Affiliation': 'Department of Neurosurgery, First Affiliated Hospital of Jiamusi University.'}, {'ForeName': 'Jia-Nan', 'Initials': 'JN', 'LastName': 'Yu', 'Affiliation': 'Department of Neurology.'}, {'ForeName': 'Si-Hui', 'Initials': 'SH', 'LastName': 'Ai', 'Affiliation': 'Department of Neurology, Jiamusi University, Jiamusi.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Ji', 'Affiliation': 'Department of Neurology, Jiamusi University, Jiamusi.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Department of Neurology, Sun Yat-sen University, Guangzhou.'}, {'ForeName': 'Xiao-Feng', 'Initials': 'XF', 'LastName': 'Zhu', 'Affiliation': 'Mudanjiang Medical University, Mudanjiang.'}, {'ForeName': 'Ji-Guang', 'Initials': 'JG', 'LastName': 'Liu', 'Affiliation': 'Jiamusi University School of Basic Medicine, Jiamusi, China.'}]",Medicine,['10.1097/MD.0000000000025208'] 3189,33832077,"The effect of insulin pump combined with ulinastatin on the levels of PCT, TG, PTX-3, and CX3CL1 in patients with diabetic ketoacidosis and pancreatitis.","ABSTRACT The aim of this research is to observe the effect of insulin pump combined with Ulinastatin on the levels of procalcitonin (PCT), triglycerides (TG), pentraxin-3(PTX-3), and C-X3-C motif chemokine ligand 1 (CX3CL1) in patients with diabetic ketoacidosis and pancreatitis.A total of 72 patients with diabetic ketoacidosis and pancreatitis who were admitted to our hospital from February 2016 to February 2020 were selected as the research subjects. They were divided into study groups (36 cases, given insulin pump combined Ulinastatin treatment) and control group (36 cases, given insulin pump treatment). Statistics of changes in blood amylase (AMS), blood glucose, blood ketones, glycosylated hemoglobin (HbA1c), PCT, TG, PTX-3, and chemokine CX3CL in pancreatic tissue before and after treatment.After treatment, the clinical efficacy of the study group was significantly higher than that of the control group (94.44% vs 75.00%), the difference was significant (P < .05). After treatment, the clinical symptoms (abdominal distension, abdominal pain, body temperature, blood sugar, HbA1c and blood amylase) in the study group were significantly less time-to-normal than in the control group, and the difference was significant (P < .05). After treatment, the AMS, blood sugar, HbA1c, and blood ketones of the 2 groups were all lower than before treatment, and the study group's AMS, blood sugar, HbA1c, and blood ketones were all lower In the control group, the difference was significant (P < .05). After treatment, the 2 groups of PCT, TG, PTX-3, and CX3CL were all lower than before treatment, among which the study group PCT, TG, PTX-3, and CX3CL1 were lower than the control group, the difference was significant (P < .05). After treatment, the total adverse reaction rate of the 2 groups was not significantly different (P > .05), but the total adverse reaction rate of the study group was lower than that of the control group.The combination of insulin pump and ulinastatin in the treatment of patients with diabetic ketoacidosis complicated with acute pancreatitis has a effect, which can shorten the recovery time of clinical symptoms, reduce the levels of PCT, TG, PTX-3, and CX3CL1, and has fewer adverse reactions. It is worthy of clinical application.",2021,"After treatment, the total adverse reaction rate of the 2 groups was not significantly different (P > .05), but the total adverse reaction rate of the study group was lower than that of the control group.","['72 patients with diabetic ketoacidosis and pancreatitis who were admitted to our hospital from February 2016 to February 2020 were selected as the research subjects', 'patients with diabetic ketoacidosis complicated with acute pancreatitis', 'patients with diabetic ketoacidosis and pancreatitis']","['insulin pump combined with Ulinastatin', 'insulin pump and ulinastatin', 'insulin pump combined with ulinastatin', 'insulin pump combined Ulinastatin treatment) and control group (36 cases, given insulin pump treatment']","['TG, PTX-3, and CX3CL1', 'levels of PCT, TG, PTX-3, and CX3CL1', 'clinical efficacy', 'total adverse reaction rate', 'time-to-normal', 'PCT, TG, PTX-3, and CX3CL', 'AMS, blood sugar, HbA1c, and blood ketones', 'clinical symptoms (abdominal distension, abdominal pain, body temperature, blood sugar, HbA1c and blood amylase', 'levels of procalcitonin (PCT), triglycerides (TG), pentraxin-3(PTX-3), and C-X3-C motif chemokine ligand 1 (CX3CL1', 'blood amylase (AMS), blood glucose, blood ketones, glycosylated hemoglobin (HbA1c), PCT, TG, PTX-3, and chemokine CX3CL in pancreatic tissue']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0001339', 'cui_str': 'Acute pancreatitis'}]","[{'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0077906', 'cui_str': 'urinastatin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}, {'cui': 'C1741764', 'cui_str': 'CX3CL1 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0002712', 'cui_str': 'Amylases'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0853725', 'cui_str': 'Blood amylase'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}]",72.0,0.0292624,"After treatment, the total adverse reaction rate of the 2 groups was not significantly different (P > .05), but the total adverse reaction rate of the study group was lower than that of the control group.","[{'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Wei', 'Affiliation': 'Department of Geriatrics, Tangshan Worker Hospital.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Yin', 'Affiliation': 'Department of Geriatrics, Tangshan Worker Hospital.'}, {'ForeName': 'Songtao', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Department of Geriatrics, Tangshan Worker Hospital.'}, {'ForeName': 'Juwen', 'Initials': 'J', 'LastName': 'Xiong', 'Affiliation': 'Department of Emergency, Tangshan 120 Emergency Command Center.'}, {'ForeName': 'Lishuang', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Department of Rehabilitation, Tangshan Worker Hospital.'}, {'ForeName': 'Shaoru', 'Initials': 'S', 'LastName': 'Yan', 'Affiliation': ""Department of Orthopaedics, Tangshan People's Hospital.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Meng', 'Affiliation': 'Department of Rheumatology and Immunology, Tangshan Worker Hospital, Tangshan, China.'}]",Medicine,['10.1097/MD.0000000000025141'] 3190,33832076,Intravenous versus oral omeprazole on patients with high risk bleeding peptic ulcers: A prospective randomized clinical trial protocol.,"BACKGROUND Proton pump inhibitors (PPIs) decrease the rate of rebleeding following endoscopic hemostatic therapy in patients with bleeding peptic ulcers. This study compares the efficacy of oral omeprazole vs intravenous omeprazole in decrease of rebleeding of peptic ulcer patients. METHOD The present study was authorized by the local research ethics committee of Jiangjin District Central Hospital (2020120987) and informed consent was obtained from all patients. All adult patients who were admitted to medical emergency rooms of Jiangjin District Central Hospital due to upper gastrointestinal bleeding (as evidenced by hematemesis, melena or hematochezia) were considered for inclusion in the study. Endoscopy was performed within 24 hours after admission. Patients older than 18 years with successful endoscopic therapy of high risk ulcers [defined as active bleeding (Forrest IA, IB), non-bleeding visible vessel (NBVV, Forrest IIA) or adherent clots (Forrest IIB)] were enrolled. Patients with low risk ulcers (clean base, ulcers with a simple washable clot), suspicious malignant ulcer, bleeding tendency, uremia, liver cirrhosis, Mallory Weiss tear or already on PPI as an outpatient were excluded from study. All were managed endoscopically by injecting 5-30 ml of epinephrine (diluted 1:10000) around the ulcer crater. Cavitations or flattening of bleeding vessel and disappearance of NBVV was considered as established homeostasis. A biopsy was taken from antrum for evaluating Helicobacter pylori infection. Patient with unsuccessful endoscopic therapy were not enrolled and were referred to general surgeon. Information on demography, history of previous upper gastrointestinal bleeding, NSAID or ASA ingestion, ulcer location, bleeding stigmata and blood transfusion volume at entry were recorded in all patients. In the oral omeprazole group, the patients received 40 mg omeprazole orally twice daily for 72 hours. In intravenous omeprazole group, they received omeprazole 80 mg bolus and then 8 mg/hour infusion for 48-72 hours. Then, all patients received omeprazole 20 mg orally for 30 days. On the day of discharge Helicobacter pylori infected patients received standard regimens. RESULTS Figure 1 showed the primary and secondary end points. DISCUSSION Intravenous administration of PPIs has limitations. They are expensive, require a dedicated intravenous line, need nursing supervision and hospital admission. So, it would be reasonable to prescribe oral PPIs to patients with high risk bleeding ulcers provided that it is as effective as its intravenous counterpart. Oral PPIs have a high bioavailability. Its effect initiates one hour after ingestion and the maximal plasma concentration is achieved after 2-3 hours. However, there are few studies comparing oral and intravenous PPI in decreasing risk of rebleeding in peptic ulcer patients. More high quality randomized controlled trials are still necessary. REGISTRATION NUMBER researchregistry 6588.",2021,"Information on demography, history of previous upper gastrointestinal bleeding, NSAID or ASA ingestion, ulcer location, bleeding stigmata and blood transfusion volume at entry were recorded in all patients.","['patients with high risk bleeding peptic ulcers', 'Patients with low risk ulcers (clean base, ulcers with a simple washable clot), suspicious malignant ulcer, bleeding tendency, uremia, liver cirrhosis, Mallory Weiss tear or already on PPI as an outpatient were excluded from study', 'peptic ulcer patients', 'patients with high risk bleeding ulcers', 'patients with bleeding peptic ulcers', 'All adult patients who were admitted to medical emergency rooms of Jiangjin District Central Hospital due to upper gastrointestinal bleeding (as evidenced by hematemesis, melena or hematochezia', 'Patients older than 18\u200ayears with successful endoscopic therapy of high risk ulcers [defined as active bleeding (Forrest IA, IB), non-bleeding visible vessel (NBVV, Forrest IIA) or adherent clots (Forrest IIB)] were enrolled', 'Patient with unsuccessful endoscopic therapy were not enrolled and were referred to general surgeon']","['Proton pump inhibitors (PPIs', 'endoscopic hemostatic therapy', 'oral omeprazole', 'PPIs', 'omeprazole', 'intravenous PPI', 'epinephrine']","['rate of rebleeding', 'demography, history of previous upper gastrointestinal bleeding, NSAID or ASA ingestion, ulcer location, bleeding stigmata and blood transfusion volume at entry', 'risk of rebleeding', 'maximal plasma concentration', 'Cavitations or flattening of bleeding vessel and disappearance of NBVV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030922', 'cui_str': 'Peptic ulcer with hemorrhage'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0009074', 'cui_str': 'Clotrimazole'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0041948', 'cui_str': 'Uremia'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0024633', 'cui_str': 'Mallory-Weiss syndrome'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030920', 'cui_str': 'Peptic ulcer'}, {'cui': 'C0333291', 'cui_str': 'Bleeding ulcer'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0041909', 'cui_str': 'Upper gastrointestinal bleeding'}, {'cui': 'C0018926', 'cui_str': 'Hematemesis'}, {'cui': 'C0025222', 'cui_str': 'Melena'}, {'cui': 'C0018932', 'cui_str': 'Hematochezia'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1272705', 'cui_str': 'Unsuccessful'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0334885', 'cui_str': 'General surgeon'}]","[{'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0041909', 'cui_str': 'Upper gastrointestinal bleeding'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1510420', 'cui_str': 'Cavity'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}]",,0.0406294,"Information on demography, history of previous upper gastrointestinal bleeding, NSAID or ASA ingestion, ulcer location, bleeding stigmata and blood transfusion volume at entry were recorded in all patients.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology, Jiangjin District Central Hospital, Chongqing, China, 402260.'}, {'ForeName': 'Panya', 'Initials': 'P', 'LastName': 'Diao', 'Affiliation': ''}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000025136'] 3191,33832054,[The effect of extended depth of focus contact lenses on the accommodation of presbyopic eyes].,"Objective: To evaluate the effect of extended depth of focus contact lenses on the accommodation of presbyopic eyes. Methods: It was a double-blind randomized controlled trial. Thirty eyes of 30 emmetropic volunteers (15 males, 15 females) who were staff or family members of Hainan Eye Hospital, aged (49.6±4.5) years, were selected. Non-dominant eyes were fitted with soft contact lenses with an extended depth of field. The subjects and examiners were double-blind. Visual acuities of the subjects were examined at 5 m, 40 cm and 60 cm distance before and after the contact lens wear. Meanwhile, the monocular accommodative amplitude, monocular accommodative facility (±1.00 D), accommodative response, binocular positive/negative relative accommodation and accommodation convergence/accommodation at 40 cm distance were measured. The data were analyzed by paired t test and Wilcoxon signed rank test before and after the contact lens wear, and a P value less than 0.05 was considered statistically significant. Results: Before and after the contact lens wear, the visual acuity at 40 cm was 4.59±0.14 and 4.69±0.10, and the difference was statistically significant ( t =4.16, P <0.01). The visual acuity at 60 cm was 4.74±0.10 and 4.74±0.12, and the difference had no statistical significance ( t =0.626, P >0.05). The distance visual acuity was 5.00±0.06 and 4.96±0.06, and the difference was statistically significant ( t =3.89, P <0.01). The monocular accommodative amplitude was significantly improved from (3.26±0.26) D to (4.00±0.51) D ( t =7.59, P <0.01). The monocular accommodative facility was also significantly improved from (2.67±1.60) cyc/min to (3.53±1.87) cyc/min ( t =2.17, P <0.05). There was no statistically significant difference in the positive and negative relative accommodation ( t =1.90, 0.66; P >0.05). The accommodation convergence/accommodation and adjustment lag had no statistical significance ( Z =0.83, 0.11; P >0.05). Conclusion: Wearing contact lenses with an extended depth of field can improve the near vision and accommodation of presbyopes ( Chin J Ophthalmol, 2021, 57:292-296) .",2021,"The monocular accommodative facility was also significantly improved from (2.67±1.60) cyc/min to (3.53±1.87) cyc/min ( t =2.17, P <0.05).","['Thirty eyes of 30 emmetropic volunteers (15 males, 15 females) who were staff or family members of Hainan Eye Hospital, aged (49.6±4.5) years, were selected. Non-dominant eyes were fitted with soft contact lenses with an extended depth of field']",['extended depth of focus contact lenses'],"['monocular accommodative amplitude, monocular accommodative facility (±1.00 D), accommodative response, binocular positive/negative relative accommodation and accommodation convergence/accommodation at 40 cm distance', 'visual acuity', 'Visual acuities', 'positive and negative relative accommodation', 'monocular accommodative amplitude', 'distance visual acuity', 'monocular accommodative facility']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0445505', 'cui_str': 'Hainan'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0009838', 'cui_str': 'Hydrophilic contact lens'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}]","[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0009836', 'cui_str': 'Contact lenses'}]","[{'cui': 'C1627880', 'cui_str': 'Accommodative amplitude'}, {'cui': 'C1827224', 'cui_str': 'Accommodative response'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0443193', 'cui_str': 'Convergence'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}]",30.0,0.225453,"The monocular accommodative facility was also significantly improved from (2.67±1.60) cyc/min to (3.53±1.87) cyc/min ( t =2.17, P <0.05).","[{'ForeName': 'L N', 'Initials': 'LN', 'LastName': 'Liu', 'Affiliation': 'Hainan Eye Hospital and Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Haikou 570311, China.'}, {'ForeName': 'X W', 'Initials': 'XW', 'LastName': 'Zhong', 'Affiliation': 'Hainan Eye Hospital and Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Haikou 570311, China.'}, {'ForeName': 'T F', 'Initials': 'TF', 'LastName': 'Wu', 'Affiliation': 'Hainan Eye Hospital and Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Haikou 570311, China.'}]",[Zhonghua yan ke za zhi] Chinese journal of ophthalmology,['10.3760/cma.j.cn112142-20200718-00488'] 3192,33832035,[Effect of subpressure on the bonding strength of resin to polycrystalline particulates modified zirconia ceramic].,"Objective: To explore the effect of subpressure on the bonding strength of resin to polycrystalline particulates modified zirconia ceramic. Methods: One hundred and twenty pre-sintered zirconia discs were prepared and divided into the control group, the sandblasting group and the 30, 50, 70 s acid etching group (24 per group) by the random number table method. There was no additional treatment in the control group and sandblasting group before sinering. The 30, 50, and 70 s acid etching groups were immersed in HF for 30, 50, 70 s, respectively, and then they were placed into CaCl 2 solution for 90 s and dipped in NaOH solution at 80 ℃ for 2 h. After sintering, the sandblasting group was subjected to sandblasting. The surface tomography and roughness were tested. According to whether subpressure was applied or not after the adhesives were applied, each group was randomly divided into two subgroups with a random number table: a subpressure subgroup and a normal pressure subgroup (12 per subgroup). Resin columns were bonded to these specimens. Shear bonding strength (SBS) test was conducted and the bonding interface, fracture surface and failure mode were analyzed. Results: The surface of control group was smooth, and its roughness was (0.24±0.11) μm. The rough surface was formed after sandblasting in the sandblasting group, and its roughness was (0.95±0.12) μm. The surface roughness of 30, 50, 70 s acid etching groups [(0.60±0.15), (1.04±0.11), (1.57±0.16) μm] increased as the HF immersion time prolonged, and the difference in surface roughness of zirconia specimens among each group was statistically significant ( P <0.05). The SBS values between zirconia and resin of all the subpressure subgroups, namely: the control group, the sandblasting group, and the 30, 50, 70 s acid etching group [(13.56±1.19), (20.98±2.11), (17.37±2.44), (24.19±2.97), (21.36±2.16) MPa] were significantly stronger than those in the normal pressure subgroups, namely: the control group, sandblasting group, 30, 50, 70 s acid etching group [(10.74±0.93), (18.47±2.14), (14.81±1.54), (20.74±2.56), (17.75±2.54) MPa] ( P <0.05). No obvious gaps and bubbles were observed in the bonding interfaces in subpressure subgroups. The proportion of mixed failure was significantly increased after applying subpressure ( P <0.05). Conclusions: The subpressure can effectively enhance the bonding strength between the resin and polycrystalline particulates modified zirconia ceramic and improve the bonding effect.",2021,The proportion of mixed failure was significantly increased after applying subpressure ( P <0.05). ,"['resin to polycrystalline particulates modified zirconia ceramic', 'One hundred and twenty pre-sintered zirconia discs']","['subpressure subgroup and a normal pressure subgroup', 'CaCl 2 solution for 90 s and dipped in NaOH solution', 'subpressure']","['SBS values', 'Shear bonding strength (SBS', 'HF immersion time prolonged', 'proportion of mixed failure', 'bonding strength', 'surface roughness of zirconia specimens']","[{'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0457784', 'cui_str': 'Particulate'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0037390', 'cui_str': 'Snuff tobacco'}]","[{'cui': 'C0003380', 'cui_str': 'Antimony'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",,0.0766807,The proportion of mixed failure was significantly increased after applying subpressure ( P <0.05). ,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': 'Institute of Dental Research, Capital Medical University School of Stomatology, Beijing 100050, China.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Ding', 'Affiliation': 'Institute of Dental Research, Capital Medical University School of Stomatology, Beijing 100050, China.'}, {'ForeName': 'Y M', 'Initials': 'YM', 'LastName': 'Tian', 'Affiliation': 'Department of Prosthodontics, Capital Medical University School of Stomatology, Beijing 100050, China.'}, {'ForeName': 'Z T', 'Initials': 'ZT', 'LastName': 'Zhang', 'Affiliation': 'Institute of Dental Research, Capital Medical University School of Stomatology, Beijing 100050, China.'}]",Zhonghua kou qiang yi xue za zhi = Zhonghua kouqiang yixue zazhi = Chinese journal of stomatology,['10.3760/cma.j.cn112144-20200929-00518'] 3193,33831981,Osteopathic manipulative medicine in the management of headaches associated with postconcussion syndrome.,"CONTEXT Previous studies have demonstrated the effectiveness of osteopathic manipulative treatment (OMT) for various headache types, with limited evidence of its use for headaches related to mild traumatic brain injury (MTBI). No studies prior studies were found regarding OMT for headaches in patients with postconcussion syndrome (PCS), defined as symptom persistence for longer than 3 months after MTBI. OBJECTIVES To evaluate OMT for headaches in patients with PCS. METHODS A controlled pilot study was conducted of patients with PCS who presented to an outpatient interdisciplinary rehabilitation clinic; patients with symptoms lasting longer than 3 months were enrolled and randomly assigned to an OMT treatment group or a control group. Primary outcome measures were immediate change in headache scores according to a Visual Analog Scale (VAS) and change in the six item Headache Impact Test (HIT-6) between baseline and follow up visits. The participants in the control group completed the HIT-6 between baseline and follow up visits but did not receive OMT and did not complete the VAS. Mean immediate VAS score change for the treatment group and mean improvement in HIT-6 scores for both groups between baseline and follow up were analyzed for statistical significance. RESULTS A total of 26 patients were included in this study: 13 (50%) in the treatment group and 13 (50%) in the control group. Six patients (23.1%), three from each group, did not complete the study, so 10 subjects in each group were included in the final analysis. Statistically significant improvement in VAS scores was seen immediately after OMT in the treatment group (mean change, 2.1;p=0.002). Mean HIT-6 scores showed improvement in the treatment group compared with the control group, although the change was not statistically significant (p=0.15) from baseline to follow up visit. No adverse effects from treatments were noted. CONCLUSIONS Patients with headaches secondary to PCS showed immediate benefit in headache pain intensity after OMT. However, no sustained benefit was found on the follow up visit compared with the control group.",2021,The participants in the control group completed the HIT-6 between baseline and follow up visits but did not receive OMT and did not complete the VAS.,"['patients with postconcussion syndrome (PCS', 'patients with PCS who presented to an outpatient interdisciplinary rehabilitation clinic; patients with symptoms lasting longer than 3 months', 'patients with PCS', 'headaches associated with postconcussion syndrome', 'A total of 26 patients were included in this study: 13 (50%) in the treatment group and 13 (50%) in the control group']","['osteopathic manipulative treatment (OMT', 'OMT treatment group or a control group', 'OMT', 'Osteopathic manipulative medicine']","['Mean immediate VAS score change', 'VAS scores', 'adverse effects', 'HIT-6 scores', 'headache pain intensity', 'Mean HIT-6 scores', 'immediate change in headache scores according to a Visual Analog Scale (VAS) and change in the six item Headache Impact Test (HIT-6']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0546983', 'cui_str': 'Postconcussion syndrome'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C3839785', 'cui_str': 'Rehabilitation clinic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0949744', 'cui_str': 'Osteopathic manipulation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1562764', 'cui_str': 'Osteopathic manipulative medicine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",26.0,0.0279204,The participants in the control group completed the HIT-6 between baseline and follow up visits but did not receive OMT and did not complete the VAS.,"[{'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Esterov', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Alphonsa', 'Initials': 'A', 'LastName': 'Thomas', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Hackensack Meridian Health, Shore Rehabilitation Institute, Brick Township, NJ, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Weiss', 'Affiliation': ""St. Luke's Spine and Pain Medicine Associates, Easton, PA, USA.""}]",Journal of osteopathic medicine,['10.1515/jom-2020-0035'] 3194,33831909,Residual viremia in HIV-infected patients who continue a 2-drug or switch to a 3-drug integrase strand transfer inhibitor-based regimen.,"In this randomized, single-center, open-label, 96-week, superiority, controlled trial of 50 HIV-infected patients with HIV-RNA <50 copies/mL on a two-drug regimen based on dolutegravir plus one reverse transcriptase inhibitor, switching to a single tablet regimen of cobicistat, elvitregravir, emtricitabine plus tenofovir alafenamide did not appear to mitigate the burden of residual viremia, both at week 48 and at week 96. The immunological changes observed during follow-up and the safety of the two regimens were similar.",2021,The immunological changes observed during follow-up and the safety of the two regimens were similar.,"['HIV-infected patients who continue a 2-drug or switch to a 3-drug integrase strand transfer inhibitor-based regimen', '50 HIV-infected patients with HIV-RNA <50\u200acopies/mL on a two-drug regimen based on']","['dolutegravir plus one reverse transcriptase inhibitor, switching to a single tablet regimen of cobicistat, elvitregravir, emtricitabine plus tenofovir alafenamide']",['Residual viremia'],"[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0376601', 'cui_str': 'Integrase strand transfer inhibitor-containing product'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0035668', 'cui_str': 'RNA'}]","[{'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0282519', 'cui_str': 'Reverse transcriptase inhibitor'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C3177235', 'cui_str': 'cobicistat'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C3713958', 'cui_str': 'tenofovir alafenamide'}]","[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}]",50.0,0.0792911,The immunological changes observed during follow-up and the safety of the two regimens were similar.,"[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Gianotti', 'Affiliation': 'Infectious Diseases, IRCCS San Raffaele Scientific Institute, Milano, Italy Vita-Salute San Raffaele University, Milano, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Galli', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Poli', 'Affiliation': ''}, {'ForeName': 'Liviana Della', 'Initials': 'LD', 'LastName': 'Torre', 'Affiliation': ''}, {'ForeName': 'Concetta', 'Initials': 'C', 'LastName': 'Vinci', 'Affiliation': ''}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Carini', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Galli', 'Affiliation': ''}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Nozza', 'Affiliation': ''}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Spagnuolo', 'Affiliation': ''}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Muccini', 'Affiliation': ''}, {'ForeName': 'Adriano', 'Initials': 'A', 'LastName': 'Lazzarin', 'Affiliation': ''}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Castagna', 'Affiliation': ''}]","AIDS (London, England)",['10.1097/QAD.0000000000002908'] 3195,33831901,An advanced double intravenous vasopressor automated system to treat hypotension during spinal anaesthesia for caesarean section: A pilot study.,"BACKGROUND During spinal anaesthesia for caesarean section, haemodynamic instability may lead to maternal and foetal complications. We developed a novel advanced double intravenous vasopressor automated system (ADIVA) by using a continuous blood pressure and heart rate monitor. Treatment of hypotension was based on three criteria: the drug (phenylephrine or ephedrine) according to the heart rate; the dose of vasopressor determined by the degree of hypotension; a fast or slow bolus of vasopressor administered depending on whether there was a negative or positive gradient of SBP changes, respectively. OBJECTIVE The aim of this pilot study was to investigate the feasibility of the ADIVA algorithm. DESIGN A prospective pilot study. SETTING Single obstetrics and gynaecology centre in Singapore. PATIENTS Women undergoing elective caesarean delivery under spinal anaesthesia. INTERVENTION Automated administration of ephedrine or phenylephrine based on changes in blood pressure and heart rate (via the ADIVA algorithm) detected on continuous noninvasive haemodynamic monitoring using noninvasive continuous haemodynamic monitor (Nexfin). MAIN OUTCOME MEASURES The primary outcome was the incidence of hypotension, defined as SBP less than 80% of baseline. The secondary outcome measures were reactive hypertension, total vasopressor requirement, maternal and neonatal outcomes and system performance. RESULTS Forty-five women were recruited. Thirty-one women (69.9%) had at least one reading of hypotension. SBP was within ±20% of the baseline in a mean ± SD of 79.7 ± 17.6% of measurements. Forty-four (97.8%) women required phenylephrine before delivery, while 15 (33.3%) required ephedrine. No rescue medications were required. Three women (6.7%) had nausea and two (4.4%) vomiting. All neonates had APGAR scores of 9 at 5 min. CONCLUSION The ADIVA system, with noninvasive continuous haemodynamic monitoring, was able to maintain maternal SBP within ±20% of baseline for the vast majority of the measurements. This system had good maternal and foetal outcomes with minimal intervention from the attending anaesthetist. TRIAL REGISTRATION NCT03620942.",2021,No rescue medications were required.,"['Thirty-one women (69.9%) had at least one reading of hypotension', 'Women undergoing elective caesarean delivery under spinal anaesthesia', 'Forty-five women were recruited', 'hypotension during spinal anaesthesia for caesarean section', 'Single obstetrics and gynaecology centre in Singapore']","['phenylephrine', 'ephedrine or phenylephrine', 'drug (phenylephrine or ephedrine', 'ephedrine']","['incidence of hypotension', 'nausea', 'vomiting', 'reactive hypertension, total vasopressor requirement, maternal and neonatal outcomes and system performance', 'blood pressure and heart rate', 'APGAR scores', 'hypotension', 'SBP']","[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1274104', 'cui_str': 'Obstetrics and gynecology'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}]","[{'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0014479', 'cui_str': 'Ephedrine'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}]",45.0,0.254098,No rescue medications were required.,"[{'ForeName': 'Singaraselvan', 'Initials': 'S', 'LastName': 'Nagarajan', 'Affiliation': ""From the Department of Women's Anaesthesia, KK Women's and Children's Hospital (SN, JJIC, CWT, ZGAAH, AT, BLS), Duke-NUS Medical School (SN, JJIC, CWT, AT, BLS), and Centre for Quantitative Medicine, Duke-NUS Medical School, Singapore, Singapore (RS).""}, {'ForeName': 'Jason Ju In', 'Initials': 'JJI', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'Chin Wen', 'Initials': 'CW', 'LastName': 'Tan', 'Affiliation': ''}, {'ForeName': 'Zainab Ghalib A', 'Initials': 'ZGA', 'LastName': 'Al-Hashim', 'Affiliation': ''}, {'ForeName': 'Rehena', 'Initials': 'R', 'LastName': 'Sultana', 'Affiliation': ''}, {'ForeName': 'Alex Tiong Heng', 'Initials': 'ATH', 'LastName': 'Sia', 'Affiliation': ''}, {'ForeName': 'Ban Leong', 'Initials': 'BL', 'LastName': 'Sng', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001496'] 3196,33831899,Intra-operative infusion of esmolol and pain following mastectomy: A randomised clinical trial.,"BACKGROUND Esmolol is a beta-1 selective blocker that has been shown to reduce postoperative pain. Its antinociceptive effects have not been tested following mastectomy. OBJECTIVE To evaluate the safety, efficacy and antinociception of intra-operative esmolol infusion after mastectomy. DESIGN Randomised, double-blinded, placebo-controlled trial. SETTING Tertiary referral centre, Brasília, Brazil. Recruitment: July 2015 to July 2017. PATIENTS Seventy women scheduled for mastectomy, ASA I to III, aged 18 to 75 years. Four were excluded. INTERVENTIONS All underwent general anaesthesia. The intervention group received a bolus of 0.5 mg kg-1 of esmolol over 10 min followed by a continuous infusion of 100 μg kg-1 min-1. The placebo group received saline. MAIN OUTCOME MEASURES The primary outcome was pain at rest 24 h after mastectomy as measured by a 0 to 10 numeric rating scale. RESULTS Pain scores at rest 24 h after mastectomy were lower in esmolol-treated patients compared with placebo (mean difference = -1.51, 95% confidence interval (CI), -2.36 to -0.65, P = 0.001). On arrival in the postanaesthesia care unit (PACU), the occurrence of pain was also lower in the esmolol group, at rest and on effort (P = 0.009 and P = 0.013, respectively), on discharge from PACU (P = 0.009 and P = 0.015), 12 h (P = 0.01 and P = 0.007) and on effort in the 24 postoperative hours (P = 0.003). Mean morphine consumption was reduced by 77% in the esmolol group compared with the placebo group (mean difference  = -2.52 mg, 95% CI = -3.67 to -1.38, P < 0.001). The length of hospital stay was shorter for the esmolol group (mean difference = -6.9 h, 95% CI, -13.4 to -0.31, P = 0.040). CONCLUSION Esmolol was well tolerated, allowed a notable reduction in the dose of rescue analgesics and demonstrated superior efficacy compared to placebo for pain management after mastectomy. TRIAL REGISTRATION ClinicalTrials/NCT02466542.",2021,"RESULTS Pain scores at rest 24 h after mastectomy were lower in esmolol-treated patients compared with placebo (mean difference = -1.51, 95% confidence interval (CI), -2.36 to -0.65, P = 0.001).","['Seventy women scheduled for mastectomy, ASA I to III, aged 18 to 75\u200ayears', 'Tertiary referral centre, Brasília, Brazil']","['bolus of 0.5\u200amg\u200akg-1 of esmolol', 'placebo', 'saline', 'esmolol and pain following mastectomy', 'esmolol', 'Esmolol']","['occurrence of pain', 'safety, efficacy and antinociception', 'Pain scores', 'pain at rest 24\u200ah after mastectomy as measured by a 0 to 10 numeric rating scale', 'Mean morphine consumption', 'length of hospital stay', 'postoperative pain']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0116569', 'cui_str': 'esmolol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",70.0,0.848561,"RESULTS Pain scores at rest 24 h after mastectomy were lower in esmolol-treated patients compared with placebo (mean difference = -1.51, 95% confidence interval (CI), -2.36 to -0.65, P = 0.001).","[{'ForeName': 'Fabrício T', 'Initials': 'FT', 'LastName': 'Mendonça', 'Affiliation': 'From the Department of Anaesthesiology, Base Hospital of the Federal District, Brasilia, DF (FTM, AJT, HIM, LFS) and Cardiology Department, State University of Campinas (Unicamp), Campinas, Sao Paulo, Brazil (LSFdC, ACS).'}, {'ForeName': 'Alex J', 'Initials': 'AJ', 'LastName': 'Tramontini', 'Affiliation': ''}, {'ForeName': 'Henrique I', 'Initials': 'HI', 'LastName': 'Miake', 'Affiliation': ''}, {'ForeName': 'Luciano F', 'Initials': 'LF', 'LastName': 'Seixas', 'Affiliation': ''}, {'ForeName': 'Luiz Sergio F', 'Initials': 'LSF', 'LastName': 'de Carvalho', 'Affiliation': ''}, {'ForeName': 'Andrei C', 'Initials': 'AC', 'LastName': 'Sposito', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001512'] 3197,33831896,Appetite and Energy Intake Regulation in Response to Acute Exercise.,"PURPOSE To determine if energy intake and appetite regulation differ in response to an acute bout of resistance exercise (REx) vs aerobic exercise (AEx). METHODS Physically inactive adults (n=24, 35±2% body fat, 50% female) completed 3 conditions: AEx (walking at 65-70% heart rate max for 45 minutes); REx (1-set to failure of 12 exercises); and sedentary control (SED). Each condition was initiated in the post-prandial state (35 minutes post breakfast). Appetite (visual analogue scale [VAS] for hunger, satiety, and prospective food consumption and hormones (ghrelin, PYY, and GLP-1) were measured before and 30, 90, 120, 150, and 180-minutes following a standardized breakfast. Area under the curve (AUC) was calculated using the trapezoid method. Ad libitum energy intake was evaluated at a lunch meal following the 180-minute measurements. RESULTS No differences in ad libitum energy intake (REx: 991±68; AEx: 937±65; SED: 944±76 kcals, p=0.50), nor appetite ratings (all p>0.05) were detected. AUC for ghrelin, PYY, and GLP-1 were all lower following REx vs. AEx (Ghrelin: REx: 130,737±4,928; AEx: 143,708±7,500, p=0.006; PYY: REx: 20,540±1,177; AEx: 23,812±1,592, p=0.001; and GLP-1: REx: 1,314±93; AEx: 1,615±110, p=0.013). Neither exercise condition significantly differed from SED. CONCLUSIONS Acute REx lowers both orexigenic (ghrelin) and anorectic (PYY and GLP-1) gut peptides compared to acute AEx. Ad libitum energy intake did not increase compared to SED in either exercise condition, indicating both exercise modalities have appetite and energy intake suppressing effects. Future work is needed to determine if exercise of differing modalities influences chronic appetite regulation.",2021,"AUC for ghrelin, PYY, and GLP-1 were all lower following REx vs. AEx (Ghrelin: REx: 130,737±4,928; AEx: 143,708±7,500, p=0.006; PYY: REx: 20,540±1,177; AEx: 23,812±1,592, p=0.001; and GLP-1: REx: 1,314±93; AEx: 1,615±110, p=0.013).","['n=24, 35±2% body fat, 50% female) completed 3 conditions: AEx (walking at 65-70% heart rate max for 45 minutes); REx (1-set to failure of 12 exercises); and sedentary control (SED', 'Physically inactive adults ']",['resistance exercise (REx) vs aerobic exercise (AEx'],"['nor appetite ratings', 'Appetite and Energy Intake Regulation', 'Area under the curve (AUC', 'Appetite (visual analogue scale [VAS] for hunger, satiety, and prospective food consumption and hormones (ghrelin, PYY, and GLP-1']","[{'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C1442463', 'cui_str': 'Forty-five minutes'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}]",,0.0471045,"AUC for ghrelin, PYY, and GLP-1 were all lower following REx vs. AEx (Ghrelin: REx: 130,737±4,928; AEx: 143,708±7,500, p=0.006; PYY: REx: 20,540±1,177; AEx: 23,812±1,592, p=0.001; and GLP-1: REx: 1,314±93; AEx: 1,615±110, p=0.013).","[{'ForeName': 'Tanya M', 'Initials': 'TM', 'LastName': 'Halliday', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Department of Medicine, University of Colorado, Anschutz Medical Campus, Aurora, CO Department of Health and Kinesiology, College of Health, University of Utah, Salt Lake City, UT Anschutz Health & Wellness Center at the University of Colorado, Anschutz Medical Campus, Aurora, CO Division of General Internal Medicine, Department of Internal Medicine, University of Utah, Salt Lake City, UT Division of Geriatric Medicine, Department of Medicine, University of Colorado, Anschutz Medical Campus, Aurora, CO Rocky Mountain Regional Veterans Administration, Aurora, CO.'}, {'ForeName': 'Mollie H', 'Initials': 'MH', 'LastName': 'White', 'Affiliation': ''}, {'ForeName': 'Allison K', 'Initials': 'AK', 'LastName': 'Hild', 'Affiliation': ''}, {'ForeName': 'Molly B', 'Initials': 'MB', 'LastName': 'Conroy', 'Affiliation': ''}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Melanson', 'Affiliation': ''}, {'ForeName': 'Marc-Andre', 'Initials': 'MA', 'LastName': 'Cornier', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002678'] 3198,33831649,"Use of an electronic seizure diary in a randomized, controlled trial of natalizumab in adult participants with drug-resistant focal epilepsy.","OBJECTIVE To analyze electronic diary (e-diary) use in a phase 2, randomized, controlled clinical trial (OPUS; NCT03283371) of natalizumab in adult participants with drug-resistant focal epilepsy. METHODS We developed an e-diary, which incorporated an episodic seizure diary and a daily diary reminder, for use as the primary source to record participants' daily seizure activity in the OPUS phase 2 clinical trial. Participants and/or their designated caregivers made e-diary entries by selecting seizure descriptions generated in the participants' and/or caregivers' own words at the time of screening. Seizures and seizure-free days were reported for the current day and for up to 5 and 4 retrospective days, respectively. A record of seizure symptoms entered within the prior 5-day period was displayed on accessing the diary. Changes were not permitted in the e-diary once a seizure record was saved unless a data change request was made. A paper backup diary was available. RESULTS E-diary entries (N = 15,176) from the 6-week baseline period and subsequent 24-week placebo-controlled period were analyzed for 66 adults who were randomized and dosed in the OPUS trial. The overall e-diary compliance, defined as the total number of days with any entry out of the total number of days in the baseline and placebo-controlled periods for all participants combined, was 83.6%. Caregivers made 190 (1.3%) e-diary entries. Day-of-event e-diary entries totaled 11,248 (74.1%). At least one paper backup diary was used by 36 (54.5%) participants. SIGNIFICANCE Our data highlight that good e-diary compliance can be achieved across participants in randomized clinical trials in adult focal epilepsy. In addition to identifying and addressing any barriers that may prevent a minority of participants from achieving good e-diary compliance, consideration of e-diary elements, such as recall period and reporting of seizure-free days, will facilitate the most accurate data capture in epilepsy clinical trials.",2021,"Seizures and seizure-free days were reported for the current day and for up to 5 and 4 retrospective days, respectively.","['66 adults who were randomized and dosed in the OPUS trial', 'adult participants with drug-resistant focal epilepsy']","['electronic seizure diary', 'placebo', 'natalizumab']",['overall e-diary compliance'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0014547', 'cui_str': 'Localization-related epilepsy'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1172734', 'cui_str': 'natalizumab'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",,0.745078,"Seizures and seizure-free days were reported for the current day and for up to 5 and 4 retrospective days, respectively.","[{'ForeName': 'Jagdish', 'Initials': 'J', 'LastName': 'Patel', 'Affiliation': 'Biogen, Cambridge, MA, USA. Electronic address: jagdish.patel@biogen.com.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Feng', 'Affiliation': 'Biogen, Cambridge, MA, USA. Electronic address: wei.feng@biogen.com.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Biogen, Cambridge, MA, USA. Electronic address: kellychenk@gmail.com.'}, {'ForeName': 'Jacqueline A', 'Initials': 'JA', 'LastName': 'French', 'Affiliation': 'NYU Grossman School of Medicine, New York, NY, USA. Electronic address: Jacqueline.french@nyumc.org.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Rushton', 'Affiliation': 'Biogen, Cambridge, MA, USA. Electronic address: markjrushton@btinternet.com.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hubbard', 'Affiliation': 'Biogen, Cambridge, MA, USA. Electronic address: sarah.hubbard@biogen.com.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Ren', 'Affiliation': 'Biogen, Cambridge, MA, USA. Electronic address: zheng.ren@biogen.com.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Potero', 'Affiliation': 'Biogen, Cambridge, MA, USA. Electronic address: ed.potero@biogen.com.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Parkerson', 'Affiliation': 'Biogen, Cambridge, MA, USA. Electronic address: kparkerson@stoketherapeutics.com.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2021.107925'] 3199,33831625,Early postoperative dressing removal in hand surgery: Novel concepts for individualized surgical dressing management.,"Postoperative dressing protocols after clean surgery without implant vary widely. The purpose of this study was to elucidate whether early postoperative dressing removal is a valid option, as compared to untouched dressing or twice-weekly dressing change approach. A prospective randomized study was conducted on patients who underwent carpal tunnel release (CTR) or trigger finger release (TFR) between January and November 2020. Patients were randomly distributed into 3 groups: surgical dressing untouched until first follow up (SDU); surgical dressing changed twice a week in a health maintenance organization (HMO); and surgical dressing removed at first postoperative day (SDR). Data collected included patient characteristics, pre-and post-operative functional (QuickDASH) and autonomy (Instrumental Activities of Daily Living performance (IADL)) scores, Vancouver scar scale (VSS) and potential complications. Eighty-four patients were included: 28 (33.3%), 29 (34.5%) and 27 (32.1%) in the SDU, HMO and SDR groups, respectively. Deterioration in mean IADL score at 2-week follow-up was statistically significant in the HMO group (mean delta 3.35, p = 0.008). Quick DASH score improved significantly between preoperative and 2-week follow-up values only in the SDU group (mean delta 9.12, p = 0.012). Other parameters, including wound complications, did not differ significantly between groups. Early removal of postoperative dressing and immediate wound exposure was a safe option after CTR and TFR. An untouched bulky dressing correlated with early functional improvement. Finally, iterative dressing change in HMO showed no benefit and led to significant deterioration in early postoperative autonomy. IRB APPROVAL: 0548-18-TLV. LEVEL OF EVIDENCE: I.",2021,"Other parameters, including wound complications, did not differ significantly between groups.","['patients who underwent carpal tunnel release (CTR) or trigger finger release (TFR) between January and November 2020', 'Eighty-four patients were included: 28 (33.3%), 29 (34.5%) and 27 (32.1%) in the SDU, HMO and SDR groups, respectively']",['surgical dressing untouched until first follow up (SDU); surgical dressing changed twice a week in a health maintenance organization (HMO); and surgical dressing removed at first postoperative day (SDR'],"['mean IADL score', 'patient characteristics, pre-and post-operative functional (QuickDASH) and autonomy (Instrumental Activities of Daily Living performance (IADL)) scores, Vancouver scar scale (VSS) and potential complications', 'wound complications', 'Quick DASH score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0196576', 'cui_str': 'Decompression of median nerve'}, {'cui': 'C0407128', 'cui_str': 'Release of trigger finger'}, {'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517716', 'cui_str': '33.3'}, {'cui': 'C0018720', 'cui_str': 'Health maintenance organization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C3653515', 'cui_str': 'SURGICAL DRESSINGS'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0018720', 'cui_str': 'Health maintenance organization'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}]",84.0,0.00797854,"Other parameters, including wound complications, did not differ significantly between groups.","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Atlan', 'Affiliation': 'Tel Aviv Medical Center, Department of Orthopedic Surgery, Affiliated with the Sackler Faculty of Medicine and Tel Aviv University, Weizmann St. 6, 6423906 Tel Aviv-Yafo, Israel. Electronic address: drfranckatlan@gmail.com.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Ashkenazi', 'Affiliation': 'Tel Aviv Medical Center, Department of Orthopedic Surgery, Affiliated with the Sackler Faculty of Medicine and Tel Aviv University, Weizmann St. 6, 6423906 Tel Aviv-Yafo, Israel.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Shehadeh', 'Affiliation': 'Tel Aviv Medical Center, Department of Orthopedic Surgery, Affiliated with the Sackler Faculty of Medicine and Tel Aviv University, Weizmann St. 6, 6423906 Tel Aviv-Yafo, Israel.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ben-Shabat', 'Affiliation': 'Tel Aviv Medical Center, Department of Orthopedic Surgery, Affiliated with the Sackler Faculty of Medicine and Tel Aviv University, Weizmann St. 6, 6423906 Tel Aviv-Yafo, Israel.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Shichman', 'Affiliation': 'Tel Aviv Medical Center, Department of Orthopedic Surgery, Affiliated with the Sackler Faculty of Medicine and Tel Aviv University, Weizmann St. 6, 6423906 Tel Aviv-Yafo, Israel.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Eisenberg', 'Affiliation': 'Tel Aviv Medical Center, Department of Orthopedic Surgery, Affiliated with the Sackler Faculty of Medicine and Tel Aviv University, Weizmann St. 6, 6423906 Tel Aviv-Yafo, Israel.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Rosenblatt', 'Affiliation': 'Tel Aviv Medical Center, Department of Orthopedic Surgery, Affiliated with the Sackler Faculty of Medicine and Tel Aviv University, Weizmann St. 6, 6423906 Tel Aviv-Yafo, Israel.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Tordjman', 'Affiliation': 'Tel Aviv Medical Center, Department of Orthopedic Surgery, Affiliated with the Sackler Faculty of Medicine and Tel Aviv University, Weizmann St. 6, 6423906 Tel Aviv-Yafo, Israel.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Pritsch', 'Affiliation': 'Tel Aviv Medical Center, Department of Orthopedic Surgery, Affiliated with the Sackler Faculty of Medicine and Tel Aviv University, Weizmann St. 6, 6423906 Tel Aviv-Yafo, Israel.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Factor', 'Affiliation': 'Tel Aviv Medical Center, Department of Orthopedic Surgery, Affiliated with the Sackler Faculty of Medicine and Tel Aviv University, Weizmann St. 6, 6423906 Tel Aviv-Yafo, Israel.'}]",Hand surgery & rehabilitation,['10.1016/j.hansur.2021.03.011'] 3200,33831623,Potential efficacy of high-dose inhaled salbutamol for the treatment of abdominal pain during oral food challenge.,"BACKGROUND Abdominal pain is a frequent symptom of IgE-mediated food allergy with limited therapeutic options. Visceral smooth muscle cell relaxation can be induced through beta-adrenergic stimulation. OBJECTIVE To evaluate the efficacy of inhaled salbutamol empirically used to relieve abdominal pain caused by IgE-mediated allergic reactions at one center. METHODS All double-blind placebo-controlled food challenges to peanut performed at on center between 2016 and 2021 were reviewed to identify patients that presented abdominal pain as part of their reaction. The primary outcome measure was the delay between the initiation of therapy and improvement of abdominal pain. It was compared between patients that had received inhaled salbutamol as part of their treatment and those that did not. Cox regression was performed to control for potential confounders. RESULTS During the study period, 186 positive DBPCFCs were performed, including 126 for peanut allergy. Of these, 77 were treated for abdominal pain and 57 met the criteria for inclusion in the study. Patients that received salbutamol improved significantly faster (median 12.5 minutes) than those that did not (median 65 minutes) (χ 2 =45; p<0.0001). In Cox regression, the administration of salbutamol and emesis were found to increase the rate of improvement by a hazard ratio of 11.35 (95%CI: 5.40-23.9; p<0.0005). CONCLUSION This retrospective study provides hypothesis-generating evidence for the use of salbutamol in the treatment of IgE-mediated abdominal pain. Further investigation in a double-blind randomized controlled trial is warranted.",2021,Patients that received salbutamol improved significantly faster (median 12.5 minutes) than those that did not (median 65 minutes) (χ 2 =45; p<0.0001).,"['IgE-mediated abdominal pain', '186 positive DBPCFCs were performed, including 126 for peanut allergy', 'abdominal pain during oral food challenge', 'controlled food challenges to peanut performed at on center between 2016 and 2021 were reviewed to identify patients that presented abdominal pain as part of their reaction', '77 were treated for abdominal pain and 57 met the criteria for inclusion in the study']","['placebo', 'salbutamol', 'inhaled salbutamol']","['abdominal pain', 'delay between the initiation of therapy and improvement of abdominal pain']","[{'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0559470', 'cui_str': 'Allergy to peanut'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C1269815', 'cui_str': 'Patient identification'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",,0.668622,Patients that received salbutamol improved significantly faster (median 12.5 minutes) than those that did not (median 65 minutes) (χ 2 =45; p<0.0001).,"[{'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Frugier', 'Affiliation': 'Department of Pediatrics, Section of Allergy and Clinical Immunology, Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC, Canada.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Graham', 'Affiliation': ""Department of Pediatrics, Section of Allergy and Clinical Immunology, Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC, Canada; Department of Medicine, Section of Allergy and Clinical Immunology, Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.""}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Samaan', 'Affiliation': 'Department of Pediatrics, Section of Allergy and Clinical Immunology, Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC, Canada.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Paradis', 'Affiliation': ""Department of Pediatrics, Section of Allergy and Clinical Immunology, Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC, Canada; Department of Medicine, Section of Allergy and Clinical Immunology, Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.""}, {'ForeName': 'Anne Des', 'Initials': 'AD', 'LastName': 'Roches', 'Affiliation': 'Department of Pediatrics, Section of Allergy and Clinical Immunology, Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC, Canada.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Begin', 'Affiliation': ""Department of Pediatrics, Section of Allergy and Clinical Immunology, Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC, Canada; Department of Medicine, Section of Allergy and Clinical Immunology, Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada,. Electronic address: philippe.begin.med@ssss.gouv.qc.ca.""}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2021.03.040'] 3201,33831611,"Neurological outcome, mental fatigue and occurrence of aneurysms more than 15 years after aneurysmal subarachnoid haemorrhage.","OBJECTIVES Long-term data on neurological and radiological outcome after aneurysmal subarachnoid haemorrhage (aSAH) is scarce. The aims of this study were to report neurological and radiological outcome more than 15 years after aSAH. PATIENTS AND METHODS Patients from Western Sweden with aSAH randomized to endovascular (EVT) or microsurgical treatment (MST) from 1997 to 2001 were included. Main end-points were neurological outcome assessed by modified Rankin scale (mRS), fatigue assessed by mental fatigue scale (MFS) and radiological outcome assessed by magnetic resonance angiography (MRA). Results were compared to a control group for MFS. RESULTS Forty-six patients (62.2%) of the 74 survivors replied after 15-21 years. Eighteen had MST and 28 had EVT. mRS 0-2 was found in 100% of EVT patients and in 88.8 % of MST patients. Moderate or severe mental fatigue was found in 7/28 patients (25 %) in the EVT group and 7/18 patients (38.8 % (p<0.05)) in the MST group, whereas moderate or severe mental fatigue was observed in 3/34 (8.9 %) in the control group. Twenty-nine patients agreed to do an MRA. In the EVT group, new neck remnants were found in 2/16 (12.5%) and de novo aneurysm was found in 2/16 (12.5%). In the MST group de novo aneurysm was found in 1/13 (7.7%). CONCLUSIONS Neurological outcome at long-term follow-up after aSAH was good, however mental fatigue was overrepresented compared to healthy controls, regardless of treatment modality. Residual or de novo aneurysm was found in 17% of patients warranting radiological long-term follow-up.",2021,"Neurological outcome at long-term follow-up after aSAH was good, however mental fatigue was overrepresented compared to healthy controls, regardless of treatment modality.","['aneurysmal subarachnoid haemorrhage (aSAH', 'than 15 years after aneurysmal subarachnoid haemorrhage', 'Patients from Western Sweden with aSAH randomized to endovascular (EVT) or microsurgical treatment (MST) from 1997 to 2001 were included', 'Forty-six patients (62.2%) of the 74 survivors replied after 15-21 years', 'Twenty-nine patients agreed to do an MRA']","['mRS', 'EVT', 'MST']","['new neck remnants', 'neurological outcome assessed by modified Rankin scale (mRS), fatigue assessed by mental fatigue scale (MFS) and radiological outcome assessed by magnetic resonance angiography (MRA', 'Residual or de novo aneurysm', 'Neurological outcome', 'Moderate or severe mental fatigue', 'mental fatigue', 'moderate or severe mental fatigue', 'Neurological outcome, mental fatigue and occurrence of aneurysms more']","[{'cui': 'C0439651', 'cui_str': 'Aneurysmal'}, {'cui': 'C0038525', 'cui_str': 'Subarachnoid hemorrhage'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0730225', 'cui_str': '1997'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0243032', 'cui_str': 'Magnetic resonance imaging (MRI) of vessels'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0243032', 'cui_str': 'Magnetic resonance imaging (MRI) of vessels'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",29.0,0.0594555,"Neurological outcome at long-term follow-up after aSAH was good, however mental fatigue was overrepresented compared to healthy controls, regardless of treatment modality.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Samuelsson', 'Affiliation': 'Institute of neurosciences and Physiology, Sahlgrenska Academy, Gothenburg University, Sweden; Department of Neurosurgery, Sahlgrenska University Hospital, Gothenburg, Sweden. Electronic address: Jennifer.samuelsson@vgregion.se.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Jakobsson', 'Affiliation': 'Institute of neurosciences and Physiology, Sahlgrenska Academy, Gothenburg University, Sweden.'}, {'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Rentzos', 'Affiliation': 'Department of Diagnostic and interventional neuroradiology, Sahlgrenska University Hospital, Gothenburg, Sweden; Department of Radiology, Institute of clinical sciences, University of Gothenburg, Sweden.'}, {'ForeName': 'Asgeir S', 'Initials': 'AS', 'LastName': 'Jakola', 'Affiliation': 'Institute of neurosciences and Physiology, Sahlgrenska Academy, Gothenburg University, Sweden; Department of Neurosurgery, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Nilsson', 'Affiliation': 'Institute of neurosciences and Physiology, Sahlgrenska Academy, Gothenburg University, Sweden; Department of Neurosurgery, Sahlgrenska University Hospital, Gothenburg, Sweden.'}]",World neurosurgery,['10.1016/j.wneu.2021.03.148'] 3202,33831600,A Surgeon Badge or Text Message Sign-in Intervention Improves Operating Room Start Efficiency.,"BACKGROUND Operating room (OR) efficiency, often measured by first case on-time start (FCOTS) percentage, is an important driver of perioperative team morale and the financial success of a hospital. MATERIALS AND METHODS In this quasi-experimental study of elective surgical procedures at a single tertiary academic hospital, an intervention requiring attending surgeon attestation of availability via SMS text message or identification badge swipe was implemented. Key measures of OR efficiency were compared before and after the change. RESULTS FCOTS percentage increased from 61.6% to 66.9% after the intervention (P = 0.01). After adjusting for patient and procedural characteristics, postintervention period remained associated with an increased odds of an on-time start (odds ratio 1.29, P = 0.01). Additionally, procedural start times from the pre- to postintervention period were significantly improved (-0.08 min/day, P = 0.009). CONCLUSIONS Implementation of an attending surgeon text or badge sign-in process was associated with improved FCOTS percentage and earlier procedure start times.",2021,"RESULTS FCOTS percentage increased from 61.6% to 66.9% after the intervention (P = 0.01).",[],['Message Sign-in Intervention'],"['procedural start times', 'FCOTS percentage', 'OR efficiency']",[],"[{'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1301880', 'cui_str': 'Start time'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0029064', 'cui_str': 'Operating theatre'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",,0.0353917,"RESULTS FCOTS percentage increased from 61.6% to 66.9% after the intervention (P = 0.01).","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Kane', 'Affiliation': 'Department of Surgery, University of Virginia Health System, Charlottesville, Virginia.'}, {'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Shilling', 'Affiliation': 'Department of Anesthesiology, University of Virginia Health System, Charlottesville, Virginia.'}, {'ForeName': 'Anneke T', 'Initials': 'AT', 'LastName': 'Schroen', 'Affiliation': 'Department of Surgery, University of Virginia Health System, Charlottesville, Virginia. Electronic address: ats2x@virginia.edu.'}]",The Journal of surgical research,['10.1016/j.jss.2021.02.009'] 3203,33836476,Epilepsy Outcome at Four Years in a Randomized Clinical Trial Comparing Oral Prednisolone and Intramuscular ACTH in West Syndrome.,"BACKGROUND This article explores the role of initial treatment on control of spasms and other epilepsies at four years in children previously treated for West syndrome. METHODS The Sri Lanka Infantile Spasm Study is a prospective clinical trial evaluating response to intra-muscular adrenocorticotropic hormone (ACTH) versus oral prednisolone. A previous report documented response through age 12 months. This article provides four-year follow-up data. RESULTS At age four years, 65 of the original 97 were available for follow-up; another 13 had died, and 19 moved and could not be contacted. Of the 65 children, 37 (57%) continued to have seizures and 28 were seizure free. In the 37 children with ongoing epilepsy, 32.4% continued to have spasms, either alone or in combination with other seizure types. The epilepsy types seen in these children were focal epilepsy (59.4%), mixed focal and generalized epilepsy (24%), generalized epilepsy only (10.8%), and uncertain (5%). The majority of those still having epilepsy (66.7%) were controlled on medication. There was no significant difference in the rate of epilepsy or spasms or their control by medication between those treated with ACTH or oral prednisolone. Spasm control at day 14 did not influence the four-year spasm or epilepsy outcome. CONCLUSIONS A majority of children diagnosed with West syndrome continued to have seizures at age four years, although most were controlled on antiseizure medication. The long-term risk of developing epilepsy or its control was the same, regardless of whether ACTH or prednisolone was initially used as treatment.",2021,There was no significant difference in the rate of epilepsy or spasms or their control by medication between those treated with ACTH or oral prednisolone.,"['At age four years, 65 of the original 97 were available for follow-up; another 13 had died, and 19 moved and could not be contacted', '65 children, 37 (57%) continued to have seizures and 28 were seizure free', 'children diagnosed with West syndrome', 'West Syndrome', 'children previously treated for West syndrome', '37 children with ongoing epilepsy, 32.4% continued to have spasms, either alone or in combination with other seizure types']","['intra-muscular adrenocorticotropic hormone (ACTH) versus oral prednisolone', 'ACTH or oral prednisolone', 'ACTH or prednisolone', 'Oral Prednisolone and Intramuscular ACTH']","['generalized epilepsy', 'rate of epilepsy or spasms', 'mixed focal and generalized epilepsy', 'focal epilepsy']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0578671', 'cui_str': 'Does move'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C1299590', 'cui_str': 'Seizure free'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C4517709', 'cui_str': '32.4'}, {'cui': 'C0026821', 'cui_str': 'Cramp'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0358513', 'cui_str': 'Prednisolone-containing product in oral dose form'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}]","[{'cui': 'C0014548', 'cui_str': 'Generalized epilepsy'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0026821', 'cui_str': 'Cramp'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0014547', 'cui_str': 'Localization-related epilepsy'}]",37.0,0.216428,There was no significant difference in the rate of epilepsy or spasms or their control by medication between those treated with ACTH or oral prednisolone.,"[{'ForeName': 'Jithangi', 'Initials': 'J', 'LastName': 'Wanigasinghe', 'Affiliation': 'Faculty of Medicine, Department of Paediatrics, University of Colombo, Colombo, Sri Lanka. Electronic address: jithangi@gmail.com.'}, {'ForeName': 'Carukshi', 'Initials': 'C', 'LastName': 'Arambepola', 'Affiliation': 'Faculty of Medicine, Department of Community Medicine, University of Colombo, Colombo, Sri Lanka.'}, {'ForeName': 'Shalini Sri', 'Initials': 'SS', 'LastName': 'Ranganathan', 'Affiliation': 'Faculty of Medicine, Department of Pharmacology, University of Colombo, Colombo, Sri Lanka.'}, {'ForeName': 'Kasun', 'Initials': 'K', 'LastName': 'Jayasundara', 'Affiliation': 'University Paediatric Unit, Lady Ridgeway Hospital, Colombo, Sri Lanka.'}, {'ForeName': 'Ashangi', 'Initials': 'A', 'LastName': 'Weerasinghe', 'Affiliation': 'Faculty of Medicine, Department of Paediatrics, University of Colombo, Colombo, Sri Lanka.'}, {'ForeName': 'Piyumi', 'Initials': 'P', 'LastName': 'Wickramarachchi', 'Affiliation': 'Faculty of Medicine, Department of Paediatrics, University of Colombo, Colombo, Sri Lanka.'}]",Pediatric neurology,['10.1016/j.pediatrneurol.2021.01.008'] 3204,33836459,"Do baseline cognitive status, participant specific characteristics and EDSS impact changes of cognitive performance following aerobic exercise intervention in multiple sclerosis?","PURPOSE Cognitive impairment is a common symptom of multiple sclerosis (MS). Physical exercise represents a promising non-pharmacological therapy option, however, potential predictors for successful cognitive improvements mediated by exercise remain to be elucidated in order to optimize targeted exercise training regimens. One of the most promising exercise training regime in this context is high-intensity interval training (HIIT). Against this backdrop, this study i) analysed the effects of a three-week HIIT compared to moderate continuous exercise on cognitive performance and ii) investigated potential predictors for changes of cognitive performance following a three-week aerobic exercise intervention. METHODS Datasets of two randomized controlled trials (RCT) were pooled, resulting in a total sample size of n = 130 persons with MS (pwMS) who either performed HIIT or moderate intensity continuous (MCT) exercise 3-5x/ week for three weeks. Cognitive performance was assessed with the Brief International Cognitive Assessment for MS. I) Potential within (time) and interaction (time x group) effects for cognitive performance were investigated with univariate analyses of covariance (ANCOVA). II) Potential predictors for changes of cognitive performance were assessed by multiple linear regression models. RESULTS ANCOVA revealed significant time effects for all cognitive outcomes and a time x group interaction for verbal learning (p=.045), with HIIT inducing superior effects compared to moderate continuous exercise (MCT). Cognitive status (impaired/intact cognition) (p= .008) and exercise regime (HIIT/moderate continuous) (p=.040) influenced changes of verbal learning. Cognitive status (p=.006) and EDSS (p=.048) affected changes of visuospatial memory in pwMS. The models accounted for 5.4% and 7.7% of the variance. CONCLUSION Cognitive status, exercise regime and EDSS potentially impact changes of specific cognitive domains following aerobic exercise. Further predictors for changes of cognitive performance following an aerobic exercise intervention need to be investigated as current results accounted only for a limited amount of variance. RCTs that investigate effects of physical exercise on cognitive performance should include only pwMS with impaired baseline cognitive performance. To better understand the impact of exercise on cognitive performance, it is furthermore recommendable to include cognitive assessments in clinical routine.",2021,"x group interaction for verbal learning (p=.045), with HIIT inducing superior effects compared to moderate continuous exercise (MCT).","['Datasets of two randomized controlled trials (RCT) were pooled, resulting in a total sample size of n\xa0=\xa0130 persons with MS (pwMS) who either performed HIIT or moderate intensity continuous (MCT) exercise 3-5x/ week for three weeks']","['Physical exercise', 'verbal learning', 'aerobic exercise intervention', 'physical exercise']","['Cognitive performance', 'Cognitive status (impaired/intact cognition', 'Cognitive status', 'cognitive performance', 'visuospatial memory', 'changes of verbal learning']","[{'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4082109', 'cui_str': 'Three weeks'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}]",130.0,0.0225406,"x group interaction for verbal learning (p=.045), with HIIT inducing superior effects compared to moderate continuous exercise (MCT).","[{'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Rademacher', 'Affiliation': 'Institute of Cardiovascular Research and Sports Medicine, Department for Molecular and Cellular Sports Medicine, German Sport University, Cologne, Germany.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Joisten', 'Affiliation': 'Institute of Sport and Sport Science, Department of ""Performance and Health (Sports Medicine)"", Technical University Dortmund, Dortmund, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Proschinger', 'Affiliation': 'Institute of Cardiovascular Research and Sports Medicine, Department for Molecular and Cellular Sports Medicine, German Sport University, Cologne, Germany.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Hebchen', 'Affiliation': 'Institute of Cardiovascular Research and Sports Medicine, Department for Molecular and Cellular Sports Medicine, German Sport University, Cologne, Germany.'}, {'ForeName': 'Marit Lea', 'Initials': 'ML', 'LastName': 'Schlagheck', 'Affiliation': 'Institute of Sport and Sport Science, Department of ""Performance and Health (Sports Medicine)"", Technical University Dortmund, Dortmund, Germany.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Bloch', 'Affiliation': 'Institute of Cardiovascular Research and Sports Medicine, Department for Molecular and Cellular Sports Medicine, German Sport University, Cologne, Germany.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Gonzenbach', 'Affiliation': 'Department of Neurology, Clinics of Valens, Rehabilitation Centre Valens, Valens, Switzerland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Kool', 'Affiliation': 'Department of Neurology, Clinics of Valens, Rehabilitation Centre Valens, Valens, Switzerland.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Bansi', 'Affiliation': 'Department of Neurology, Clinics of Valens, Rehabilitation Centre Valens, Valens, Switzerland.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Zimmer', 'Affiliation': 'Institute of Sport and Sport Science, Department of ""Performance and Health (Sports Medicine)"", Technical University Dortmund, Dortmund, Germany. Electronic address: philipp.zimmer@tu-dortmund.de.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2021.102905'] 3205,33836458,Effects of low vs. high frequency local vibration on mild-moderate muscle spasticity: Ultrasonographical and functional evaluation in patients with multiple sclerosis.,"BACKGROUND Local vibration (LV) is a physiotherapy application that aims to reduce spasticity. The study aimed to compare the effects of 50 Hz vs. 100 Hz LV on mild-moderate spasticity, functional performance and muscle architecture. METHODS Thirty-three patients were randomly divided into three groups: 50 Hz LV group, 100 Hz LV group and the control group. Physical therapy was applied for one hour a day, three days a week, for a total of eight weeks. LV was applied to the right and left medial gastrocnemius muscles for five minutes. Clinical (spasticity, ankle joint position sense, balance, gait) and ultrasonographic (gastrocnemius fascicle length and pennation angle) measurements were performed before and after treatment. RESULTS The study was completed with 27 patients. The decrease in spasticity and the increase in fascicle length were found to be statistically significant in the 50 Hz group (both p<0.05). Ankle joint position sense, single-leg stance time, limits of stability/postural sway range in the medio-lateral direction significantly improved in the vibration treatment groups (all p<0.05). The antero-posterior limits of stability and postural sway showed significant improvement in all groups (all p<0.05). While the 50 Hz group showed significant improvement for all walking parameters; velocity, step length and base of support values improved in the 100 Hz group (all p<0.05). The exercise group showed significant improvement only for single support and stance phase percentages of the gait cycle (both p<0.05). According to between group comparisons, significant difference was found only in medio-lateral limits of stabillity (p<0.05). Medio-lateral limits of stabillity scores were better for the 50 Hz group than the 100 Hz and exercise group. CONCLUSION Our findings show that LV does not have any substantial effect except for medio-lateral limits of stability. CLINICAL TRIAL NUMBER NCT04192786.",2021,"Medio-lateral limits of stabillity scores were better for the 50 Hz group than the 100 Hz and exercise group. ","['Thirty-three patients', 'patients with multiple sclerosis', 'mild-moderate muscle spasticity', '27 patients']","['Physical therapy', 'Local vibration (LV', '50 Hz vs. 100 Hz LV', '50 Hz LV group, 100 Hz LV group and the control group', 'low vs. high frequency local vibration', 'LV']","['Clinical (spasticity, ankle joint position sense, balance, gait) and ultrasonographic (gastrocnemius fascicle length and pennation angle) measurements', 'mild-moderate spasticity, functional performance and muscle architecture', 'fascicle length', 'single support and stance phase percentages of the gait cycle', 'spasticity', 'walking parameters; velocity, step length and base of support values', 'medio-lateral limits of stabillity', 'antero-posterior limits of stability and postural sway', 'Medio-lateral limits of stabillity scores', 'Ankle joint position sense, single-leg stance time, limits of stability/postural sway range in the medio-lateral direction']","[{'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0003087', 'cui_str': 'Ankle joint structure'}, {'cui': 'C0234219', 'cui_str': 'Postural sense'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439755', 'cui_str': 'Directions'}]",33.0,0.00870106,"Medio-lateral limits of stabillity scores were better for the 50 Hz group than the 100 Hz and exercise group. ","[{'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Ayvat', 'Affiliation': 'Hacettepe University, Faculty of Physical Therapy and Rehabilitation, 06100 Samanpazarı/Altındag, Ankara, Turkey. Electronic address: fatma.avcu@hacettepe.edu.tr.'}, {'ForeName': 'Levent', 'Initials': 'L', 'LastName': 'Özçakar', 'Affiliation': 'Hacettepe University Medical School, Department of Physical and Rehabilitation Medicine, Ankara, Turkey. Electronic address: lozcakar@yahoo.com.'}, {'ForeName': 'Ender', 'Initials': 'E', 'LastName': 'Ayvat', 'Affiliation': 'Hacettepe University, Faculty of Physical Therapy and Rehabilitation, 06100 Samanpazarı/Altındag, Ankara, Turkey. Electronic address: ender.ayvat@gmail.com.'}, {'ForeName': 'Sibel', 'Initials': 'S', 'LastName': 'Aksu Yıldırım', 'Affiliation': 'Hacettepe University, Faculty of Physical Therapy and Rehabilitation, 06100 Samanpazarı/Altındag, Ankara, Turkey. Electronic address: sibelaksu@yahoo.com.'}, {'ForeName': 'Muhammed', 'Initials': 'M', 'LastName': 'Kılınç', 'Affiliation': 'Hacettepe University, Faculty of Physical Therapy and Rehabilitation, 06100 Samanpazarı/Altındag, Ankara, Turkey. Electronic address: muhammedkilinc@yahoo.com.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2021.102930'] 3206,33836436,Effectiveness of a contact-based anti-stigma intervention for police officers.,"INTRODUCTION Police force interaction rates with individuals with mental health conditions are on the rise. International research reveals that the presence of a mental health condition increases the risk for detention and use of force by police officers. Stigmatization of individuals with mental health conditions as dangerous and unpredictable is assumed to have an impact on the likelihood of police use of force. The following study examines a trialogical intervention to reduce stigmatization of individuals with a diagnosis of schizophrenia in a police officer sample. METHOD 1318 police officers participated in a trialogical contact-based intervention with the aim to reduce stigmatizing attitudes and beliefs. Emotional reactions, stereotypes and social distance were assessed prior to and after the intervention in a one-group design. RESULTS Negative stereotypes were positively associated with social distance in individuals with a diagnosis of schizophrenia and were positively associated with anxiety. Dependent sample t-test revealed reduced anxiety towards individuals with a diagnosis of schizophrenia, less negative stereotypes, and less social distance post intervention. All results were significant, and all effect sizes showed a small to moderate effect. CONCLUSIONS Trialogical contact-based, short-term anti-stigma interventions appear to reduce stigmatizing attitudes towards individuals with mental health conditions in a large police force sample. A missing control group is a key study limitation. Further research is needed to examine the effectiveness of the intervention in a randomized-controlled trial. However, the results clearly suggest that anti-stigma interventions could be beneficially introduced into police training.",2021,"CONCLUSIONS Trialogical contact-based, short-term anti-stigma interventions appear to reduce stigmatizing attitudes towards individuals with mental health conditions in a large police force sample.","['individuals with a diagnosis of schizophrenia in a police officer sample', 'police officers', 'individuals with mental health conditions', '1318 police officers participated in a trialogical contact-based intervention with the aim to reduce stigmatizing attitudes and beliefs']","['trialogical intervention', 'contact-based anti-stigma intervention']","['anxiety', 'social distance', 'Emotional reactions, stereotypes and social distance', 'stigmatizing attitudes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0086825', 'cui_str': 'Policeman'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0037412', 'cui_str': 'Social Distance'}, {'cui': 'C0221736', 'cui_str': 'Reaction emotional'}, {'cui': 'C0038272', 'cui_str': 'Stereotyping'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.0170746,"CONCLUSIONS Trialogical contact-based, short-term anti-stigma interventions appear to reduce stigmatizing attitudes towards individuals with mental health conditions in a large police force sample.","[{'ForeName': 'Linus', 'Initials': 'L', 'LastName': 'Wittmann', 'Affiliation': 'Department of Health Psychology and Health Education, University of Flensburg, Germany. Electronic address: linus.wittmann@uni-flensburg.de.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Dorner', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg Eppendorf, Germany.'}, {'ForeName': 'Imke', 'Initials': 'I', 'LastName': 'Heuer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg Eppendorf, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bock', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg Eppendorf, Germany.'}, {'ForeName': 'Candelaria', 'Initials': 'C', 'LastName': 'Mahlke', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg Eppendorf, Germany.'}]",International journal of law and psychiatry,['10.1016/j.ijlp.2021.101697'] 3207,33836311,Prospective Randomized Study of Advance Directives in Allogeneic Hematopoietic Cell Transplant Recipients.,"BACKGROUND Patients undergoing allogeneic HCT are at risk for high morbidity and mortality. Advance directives (AD) allow patients to express wishes regarding their care at the end of life, but these are not completed in the majority of patients undergoing HCT, with only 44% of deceased allogeneic HCT recipients at this institution completing an AD in the past decade. Increasing AD completion rate can improve quality of care for allogeneic HCT recipients. OBJECTIVE Evaluating whether an alternative AD instrument can increase AD completion rate and patient satisfaction. STUDY DESIGN We conducted a prospective, randomized controlled study of the traditional California AD vs. the use of a novel Letter AD, the Stanford What Matters Most Letter, in adult allogeneic HCT recipients. Patients 18 years and older undergoing first allogeneic HCT at Stanford University were eligible. Prior to HCT conditioning, enrolled patients were randomly assigned to complete either the traditional AD or the Letter AD. The primary endpoint was AD completion; the chi-squared test was used to compare the AD completion rate between arms. Wilcoxon rank-sum tests were used to compare uncertainty, satisfaction with decision-making, and satisfaction with the AD. RESULTS Of the total 212 patients who were eligible, 126 (59.4%) were enrolled and randomized. The mean age was 53.7 years; 57(45.2%) were female; 74 (58.7%) were non-Hispanic White. The overall AD completion rate was 71.4% and did not differ between the traditional and Letter AD arms (70.3% vs 72.6%, P= 0.78). Of those who completed the Letter AD, 66.7%, 42.2%, and 46.7% of patients wished to die gently/naturally, at home, and/or with hospice, respectively. The traditional AD found that 62.2% wished to not prolong life if recovery was unlikely. Opinion surveys did not find differences in levels of satisfaction between the traditional and Letter AD. CONCLUSION Completion rates of AD on this study were high (71.4%) in comparison to historically reported completion rates and did not significantly differ based upon AD version.",2021,"Opinion surveys did not find differences in levels of satisfaction between the traditional and Letter AD. ","['The mean age was 53.7 years; 57(45.2%) were female; 74 (58.7%) were non-Hispanic White', 'adult allogeneic HCT recipients', 'Of the total 212 patients who were eligible, 126 (59.4%) were enrolled and randomized', 'Patients 18 years and older undergoing first allogeneic HCT at Stanford University were eligible', 'Allogeneic Hematopoietic Cell Transplant Recipients']","['allogeneic HCT', 'Advance Directives', 'HCT', 'novel Letter AD, the Stanford']","['AD completion; the chi-squared test', 'AD completion rate and patient satisfaction', 'quality of care', 'AD completion rate', 'overall AD completion rate', 'levels of satisfaction', 'uncertainty, satisfaction with decision-making, and satisfaction with the AD']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0206152', 'cui_str': 'Cell Transplants'}]","[{'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}]","[{'cui': 'C0001683', 'cui_str': 'Advance Directives'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008041', 'cui_str': 'Chi-Square Test'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}]",212.0,0.214862,"Opinion surveys did not find differences in levels of satisfaction between the traditional and Letter AD. ","[{'ForeName': 'Irena T', 'Initials': 'IT', 'LastName': 'Tan', 'Affiliation': 'Stanford University Medical Center, Stanford, CA.'}, {'ForeName': 'Vandana', 'Initials': 'V', 'LastName': 'Sundaram', 'Affiliation': 'Quantitative Sciences Unit, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Yvette', 'Initials': 'Y', 'LastName': 'Ramirez', 'Affiliation': 'Stanford University Medical Center, Stanford, CA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Burnash', 'Affiliation': 'Stanford University Medical Center, Stanford, CA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kate Tierney', 'Affiliation': 'Stanford University Medical Center, Stanford, CA.'}, {'ForeName': 'Lori S', 'Initials': 'LS', 'LastName': 'Muffly', 'Affiliation': 'Stanford University Medical Center, Stanford, CA. Electronic address: lmuffly@stanford.edu.'}]",Transplantation and cellular therapy,['10.1016/j.jtct.2021.03.030'] 3208,33836310,Effects of exercise frequency and training volume on bone changes following a multi-component exercise intervention in middle aged and older men: Secondary analysis of an 18-month randomized controlled trial.,"Progressive resistance training (PRT) combined with weight-bearing impact exercise are recommended to optimize bone health, but the optimal frequency and dose of training remains uncertain. This study, which is a secondary analysis of an 18-month intervention in men aged 50-79 years, examined the association between exercise frequency and the volume of training with changes in DXA and QCT-derived femoral neck (FN) and lumbar spine (LS) bone outcomes, respectively. Men were allocated to either thrice-weekly PRT plus impact exercise training (n = 87) or a non-exercising (n = 85) group. Average weekly exercise frequency (ExFreq) and training volume per session [PRT volume (weight lifted, kg), number of weight-bearing impacts (jumps completed) and total training volume] over the 18-months were calculated from the participants' exercise cards. Regression analysis showed that average weekly ExFreq and training volume per session were positively associated with the 18-month changes in FN BMD and LS trabecular volumetric BMD. Men completing on average 1 to <2 and ≥ 2 sessions/week had a 1.6 to 2.2% greater net gain in FN BMD relative to non-exercising men, while those completing ≥2 sessions/week had 3.9 to 5.2% net gain in LS trabecular vBMD compared to non-exercising men and those completing <1 session/week. Further analysis showed that the average number of impact loads per session, but not the average PRT weight-lifted, was positively associated with changes in BMD. Every 10 impact loads per session over 18 months was associated with a 0.3% and 1.3% increase in FN BMD and LS trabecular vBMD, respectively. In conclusion, this study indicates that exercise frequency and training volume were predictors of the changes in hip and spine BMD following a multi-component exercise program, and that the number of impact loads rather than PRT weight lifted per session was more important for eliciting positive skeletal responses in middle-aged and older men.",2021,Regression analysis showed that average weekly ExFreq and training volume per session were positively associated with the 18-month changes in FN BMD and LS trabecular volumetric BMD.,"['middle-aged and older men', 'men aged 50-79\u202fyears', 'middle aged and older men']","['Progressive resistance training (PRT) combined with weight-bearing impact exercise', 'exercise frequency and training volume', 'thrice-weekly PRT plus impact exercise training (n\u202f=\u202f87) or a non-exercising', 'multi-component exercise intervention']","['net gain in FN BMD relative', 'Average weekly exercise frequency (ExFreq) and training volume per session [PRT volume (weight lifted, kg), number of weight-bearing impacts (jumps completed) and total training volume', 'BMD', 'exercise frequency and the volume of training with changes in DXA and QCT-derived femoral neck (FN) and lumbar spine (LS) bone outcomes', 'LS trabecular vBMD', 'FN BMD and LS trabecular vBMD', 'FN BMD and LS trabecular volumetric BMD']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0085086', 'cui_str': 'Weight-bearing'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0556455', 'cui_str': 'Frequency of exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0556455', 'cui_str': 'Frequency of exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0085086', 'cui_str': 'Weight-bearing'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0412669', 'cui_str': 'Computerized tomography, bone density study'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}]",,0.0140057,Regression analysis showed that average weekly ExFreq and training volume per session were positively associated with the 18-month changes in FN BMD and LS trabecular volumetric BMD.,"[{'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Daly', 'Affiliation': 'Institute for Physical Activity and Nutrition, Deakin University, Geelong, Australia. Electronic address: rmdaly@deakin.edu.au.'}, {'ForeName': 'Jack Dalla', 'Initials': 'JD', 'LastName': 'Via', 'Affiliation': 'Institute for Physical Activity and Nutrition, Deakin University, Geelong, Australia. Electronic address: j.dallavia@deakin.edu.au.'}, {'ForeName': 'Jackson J', 'Initials': 'JJ', 'LastName': 'Fyfe', 'Affiliation': 'Institute for Physical Activity and Nutrition, Deakin University, Geelong, Australia. Electronic address: jackson.fyfe@deakin.edu.au.'}, {'ForeName': 'Riku', 'Initials': 'R', 'LastName': 'Nikander', 'Affiliation': 'Faculty of Sports Science, Gerontology Research Centre (Gerec), University of Jyväskylä, Finland; Central Hospital of Central Finland, Jyväskylä, Finland; GeroCenter Foundation for Aging Research & Development, Jyväskylä, Finland. Electronic address: riku.p.nikander@jyu.fi.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Kukuljan', 'Affiliation': 'Institute for Physical Activity and Nutrition, Deakin University, Geelong, Australia. Electronic address: skukuljan@ffgl.com.au.'}]",Bone,['10.1016/j.bone.2021.115944'] 3209,33836265,"Cabazitaxel versus abiraterone or enzalutamide in poor prognosis metastatic castration-resistant prostate cancer: a multicentre, randomised, open-label, phase 2 trial.","PURPOSE Treatment for poor prognosis metastatic castration-resistant prostate cancer (mCRPC) includes taxane chemotherapy and androgen receptor pathway inhibitors (ARPI). We sought to determine optimal treatment in this setting. PATIENTS AND METHODS This multicentre, randomised, open-label, phase 2 trial recruited patients with ARPI-naïve mCRPC and poor prognosis features (presence of liver metastases, progression to mCRPC after <12 months of androgen deprivation therapy, or ≥4 of 6 clinical criteria). Patients were randomly assigned 1:1 to receive cabazitaxel plus prednisone (Group A) or physician's choice of enzalutamide or abiraterone plus prednisone (Group B) at standard doses. Patients could cross-over at progression. The primary endpoint was clinical benefit rate for first-line treatment (defined as PSA response ≥50%, radiographic response, or stable disease ≥12 weeks). RESULTS 95 patients were accrued (median follow-up 21.9 months). First-line clinical benefit rate was greater in Group A versus B (80% vs 62%, p=0.039). Overall survival was not different between Group A and B (median 37.0 vs 15.5 months, HR=0.58, p=0.073) nor was time to progression (median 5.3 vs 2.8 months, HR=0.87, p=0.52). The most common first-line treatment-related grade ≥3 adverse events were neutropenia (cabazitaxel 32% vs ARPI 0%), diarrhea (9% vs 0%), infection (9% vs 0%) and fatigue (7% vs 5%). Baseline circulating tumour DNA (ctDNA) fraction above the cohort median and on-treatment ctDNA increase were associated with shorter time to progression (HR = 2.38, p < 0.001; HR = 4.03, p < 0.001). Patients with >30% ctDNA fraction at baseline had markedly shorter overall survival than those with undetectable ctDNA (HR = 38.22, p < 0.001). CONCLUSIONS Cabazitaxel was associated with a higher clinical benefit rate in patients with ARPI-naïve poor prognosis mCRPC. CtDNA abundance was prognostic independent of clinical features, and holds promise as a stratification biomarker.",2021,"on-treatment ctDNA increase were associated with shorter time to progression (HR = 2.38, p < 0.001; HR = 4.03, p < 0.001).","['poor prognosis metastatic castration-resistant prostate cancer', 'patients with ARPI-naïve mCRPC and poor prognosis features (presence of liver metastases, progression to mCRPC after <12 months of androgen deprivation therapy, or ≥4 of 6 clinical criteria', 'poor prognosis metastatic castration-resistant prostate cancer (mCRPC', 'patients with ARPI-naïve poor prognosis mCRPC']","['taxane chemotherapy and androgen receptor pathway inhibitors (ARPI', ""cabazitaxel plus prednisone (Group A) or physician's choice of enzalutamide or abiraterone plus prednisone"", 'Cabazitaxel versus abiraterone or enzalutamide']","['fatigue', 'shorter time to progression', 'Baseline circulating tumour DNA (ctDNA) fraction', 'diarrhea', 'infection', 'time to progression', 'Overall survival', 'clinical benefit rate for first-line treatment (defined as PSA response ≥50%, radiographic response, or stable disease ≥12 weeks', 'overall survival']","[{'cui': 'C0278252', 'cui_str': 'Prognosis bad'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034786', 'cui_str': 'Androgen receptor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034786', 'cui_str': 'Androgen receptor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2830183', 'cui_str': 'cabazitaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439230', 'cui_str': 'week'}]",95.0,0.24555,"on-treatment ctDNA increase were associated with shorter time to progression (HR = 2.38, p < 0.001; HR = 4.03, p < 0.001).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Annala', 'Affiliation': 'Vancouver Prostate Centre, Department of Urologic Sciences, University of British Columbia, Vancouver, British Columbia, Canada; Faculty of Medicine and Health Technology, Tampere University and Tays Cancer Centre, Tampere, Finland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Fu', 'Affiliation': 'Department of Medical Oncology, BC Cancer, Vancouver, British Columbia, Canada; Oncology, School of Medical Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'J V W', 'Initials': 'JVW', 'LastName': 'Bacon', 'Affiliation': 'Vancouver Prostate Centre, Department of Urologic Sciences, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sipola', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University and Tays Cancer Centre, Tampere, Finland.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Iqbal', 'Affiliation': 'Medical Oncology, Saskatoon Cancer Centre, University of Saskatchewan, Saskatoon, Canada.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ferrario', 'Affiliation': 'Jewish General Hospital, McGill University, Montréal, Quebec, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ong', 'Affiliation': 'Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Wadhwa', 'Affiliation': 'BC Cancer - Kelowna Centre, Kelowna, British Columbia, Canada.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Hotte', 'Affiliation': 'Oncology, Juravinski Cancer Centre, Hamilton, ON, Canada.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Lo', 'Affiliation': 'Department of Medical Oncology, R. S. McLaughlin Durham Regional Cancer Centre, Lakeridge Health, Oshawa, Canada.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Tran', 'Affiliation': 'Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Wood', 'Affiliation': 'QEII Health Sciences Centre, Halifax, Canada.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Gingerich', 'Affiliation': 'Department of Medical Oncology and Hematology, CancerCare Manitoba, Winnipeg, Canada.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'North', 'Affiliation': 'Department of Oncology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Pezaro', 'Affiliation': 'Eastern Health Clinical School, Monash University, Victoria, Australia; Department of Oncology, Eastern Health, Victoria, Australia.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Ruether', 'Affiliation': 'Tom Baker Cancer Centre, Calgary, Alberta, Canada.'}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Sridhar', 'Affiliation': 'Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, Canada.'}, {'ForeName': 'H M L', 'Initials': 'HML', 'LastName': 'Kallio', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University and Tays Cancer Centre, Tampere, Finland.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Khalaf', 'Affiliation': 'Department of Medical Oncology, BC Cancer, Vancouver, British Columbia, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Vancouver Prostate Centre, Department of Urologic Sciences, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Beja', 'Affiliation': 'Vancouver Prostate Centre, Department of Urologic Sciences, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Schönlau', 'Affiliation': 'Vancouver Prostate Centre, Department of Urologic Sciences, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Taavitsainen', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University and Tays Cancer Centre, Tampere, Finland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nykter', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University and Tays Cancer Centre, Tampere, Finland.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Vandekerkhove', 'Affiliation': 'Vancouver Prostate Centre, Department of Urologic Sciences, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Azad', 'Affiliation': 'Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'A W', 'Initials': 'AW', 'LastName': 'Wyatt', 'Affiliation': 'Vancouver Prostate Centre, Department of Urologic Sciences, University of British Columbia, Vancouver, British Columbia, Canada; Michael Smith Genome Sciences Centre, BC Cancer, Vancouver, British Columbia, Canada. Electronic address: awwyatt@mail.ubc.ca.'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': 'Vancouver Prostate Centre, Department of Urologic Sciences, University of British Columbia, Vancouver, British Columbia, Canada; Department of Medical Oncology, BC Cancer, Vancouver, British Columbia, Canada. Electronic address: kchi@bccancer.bc.ca.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2021.03.205'] 3210,33835886,"A two-arm, randomized, controlled, multi-centric, open-label phase-2 study to evaluate the efficacy and safety of Itolizumab in moderate to severe ARDS patients due to COVID-19.","Objective : Efficacy and safety of Itolizumab, an immunomodulatory mAb, in treating moderate-to-severe acute respiratory distress syndrome (ARDS) due to cytokine release in COVID-19 patients was evaluated in a multi-centric, open-label, two-arm, controlled, randomized, phase-2 study. Methods : Patients were randomized (2:1) to Arm-A (best supportive care [BSC]+Itolizumab) and Arm-B (BSC). Primary outcome of interest was reduction in mortality 30-days after enrollment. Results : Thirty-six patients were screened, five treated as first-dose-sentinels and rest randomized, while four patients were screen-failures. Two patients in Arm-A discontinued prior to receiving one complete infusion and were replaced. At end of 1-month, there were three deaths in Arm-B, and none in Arm-A (p = 0.0296; 95% CI = -0.3 [-0.61, -0.08]). At end of study, more patients in Arm-A had improved SpO2 without increasing FiO2 (p = 0.0296), improved PaO2 (p = 0.0296), and reduction in IL-6 (43 vs 212 pg/ml; p = 0.0296) and tumor necrotic factor-α (9 vs 39 pg/ml; p = 0.0253) levels. Transient lymphopenia (Arm-A: 11 patients) and infusion reactions (7 patients) were commonly reported treatment-related safety events. Conclusion : Itolizumab is a promising, safe and effective immunomodulatory therapy for treatment of ARDS due to cytokine release in COVID-19 patients, with survival and recovery-benefit.",2021,"Itolizumab is a promising, safe and effective immunomodulatory therapy for treatment of ARDS due to cytokine release in COVID-19 patients, with survival and recovery-benefit.","['Thirty-six patients', 'moderate to severe ARDS patients due to COVID-19', 'moderate-to-severe acute respiratory distress syndrome (ARDS']","['Arm-A (best supportive care [BSC]+Itolizumab) and Arm-B (BSC', 'Itolizumab']","['improved PaO2', 'Transient lymphopenia', 'IL-6', 'SpO2 without increasing FiO2', 'mortality 30-days', 'tumor necrotic factor-α']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C2987424', 'cui_str': 'itolizumab'}]","[{'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}]",36.0,0.0516588,"Itolizumab is a promising, safe and effective immunomodulatory therapy for treatment of ARDS due to cytokine release in COVID-19 patients, with survival and recovery-benefit.","[{'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'MAMC Medical College and Lok Nayak Jai Prakash Narayan Hospital, New Delhi, India.'}, {'ForeName': 'Rosemarie', 'Initials': 'R', 'LastName': 'De Souza', 'Affiliation': 'Topiwala National Medical College & B. Y. L. Nair Charitable Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Milind', 'Initials': 'M', 'LastName': 'Nadkar', 'Affiliation': 'Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Randeep', 'Initials': 'R', 'LastName': 'Guleria', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Anjan', 'Initials': 'A', 'LastName': 'Trikha', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Shashank R', 'Initials': 'SR', 'LastName': 'Joshi', 'Affiliation': 'Indian College of Physicians and Lilavati Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Subramanian', 'Initials': 'S', 'LastName': 'Loganathan', 'Affiliation': 'Biocon Biologics India Ltd, Bengaluru, Karnataka, India.'}, {'ForeName': 'Sivakumar', 'Initials': 'S', 'LastName': 'Vaidyanathan', 'Affiliation': 'Biocon Biologics India Ltd, Bengaluru, Karnataka, India.'}, {'ForeName': 'Ashwani', 'Initials': 'A', 'LastName': 'Marwah', 'Affiliation': 'Biocon Biologics India Ltd, Bengaluru, Karnataka, India.'}, {'ForeName': 'Sandeep N', 'Initials': 'SN', 'LastName': 'Athalye', 'Affiliation': 'Biocon Biologics India Ltd, Bengaluru, Karnataka, India.'}]",Expert opinion on biological therapy,['10.1080/14712598.2021.1905794'] 3211,33835867,Comparison of digital image displays performance in the detection of artificial internal root resorptions lesions.,"OBJECTIVE To compare the diagnostic efficacy of different devices for visualizing digital images in detecting simulated internal root resorption (IRR). METHODS 26 uniradicular human teeth were sectioned along its long axis and randomly divided into two groups. Then, they were submerged in hydrochloric acid (HCl) P.A 37% at different times to make two types of defects: Type 1 (2 hours), and type 2 (3 hours). Digital periapical radiographs were acquired in three moments: before section, after section and after immersion in acid. The images were evaluated on three different devices: 27-inch iMac Desktop, 8-inch Android Tablet, and 5.5-inch iPhone 8 Plus using a 5-point scale. RESULTS The sensitivity and accuracy values were higher with the use of the Android Tablet, for both types of defects. For the values of the area under ROC curve, higher results were observed with the Android Tablet and lower results with the iMac, showing a significant difference ( p < 0.05) when comparing the use of the iMac with the Android Tablet and iPhone 8, for type 1 defects. When comparing the different devices, in the evaluation of images of type 2 defects, the values showed no statistical difference, regardless of the device evaluated ( p > 0.05). CONCLUSIONS The size of the lesion interferes with the detection capacity in the image. However, the use of portable devices does not impair the diagnosis of IRR, regardless of size and the dental practioners may use different devices/display, under optimal viewing conditions, to detect IRR lesions, without jeopardizing the diagnostic ability.",2021,"When comparing the different devices, in the evaluation of images of type 2 defects, the values showed no statistical difference, regardless of the device evaluated ( p > 0.05). ","['26 uniradicular human teeth', 'artificial internal root resorptions lesions']",[],"['diagnostic efficacy', 'sensitivity and accuracy values', 'Digital periapical radiographs']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0035851', 'cui_str': 'Root Resorption'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",[],"[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0729269', 'cui_str': 'Periapical'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}]",,0.0192803,"When comparing the different devices, in the evaluation of images of type 2 defects, the values showed no statistical difference, regardless of the device evaluated ( p > 0.05). ","[{'ForeName': 'Matheus Nogueira', 'Initials': 'MN', 'LastName': 'da Hora', 'Affiliation': 'Department of Propedeutics and Integrated Clinic, Division of Oral Radiology, School of Dentistry, Federal University of Bahia, Salvador, Brazil.'}, {'ForeName': 'Lucas de Paula Lopes', 'Initials': 'LPL', 'LastName': 'Rosado', 'Affiliation': 'Department of Oral Diagnosis, Division of Oral Radiology, Piracicaba Dental School, University of Campinas, Piracicaba, Brazil.'}, {'ForeName': 'Frederico Sampaio', 'Initials': 'FS', 'LastName': 'Neves', 'Affiliation': 'Department of Propedeutics and Integrated Clinic, Division of Oral Radiology, School of Dentistry, Federal University of Bahia, Salvador, Brazil.'}, {'ForeName': 'Ieda', 'Initials': 'I', 'LastName': 'Crusoé-Rebello', 'Affiliation': 'Department of Propedeutics and Integrated Clinic, Division of Oral Radiology, School of Dentistry, Federal University of Bahia, Salvador, Brazil.'}, {'ForeName': 'Taruska Ventorini', 'Initials': 'TV', 'LastName': 'Vasconcelos', 'Affiliation': 'Department of Propedeutics and Integrated Clinic, Division of Oral Radiology, School of Dentistry, Federal University of Bahia, Salvador, Brazil.'}]",Dento maxillo facial radiology,['10.1259/dmfr.20200578'] 3212,33831949,Antioxidant Supplementation Does Not Affect Bone Turnover Markers During 60 Days of 6° Head-Down Tilt Bed Rest: Results from an Exploratory Randomized Controlled Trial.,"BACKGROUND Immobilization and related oxidative stress are associated with bone loss. Antioxidants like polyphenols, omega-3 fatty acids, vitamins, and micronutrients may mitigate these negative effects on bone metabolism through scavenging of free radicals. OBJECTIVES We hypothesized that antioxidant supplementation during 60 days of 6° head-down tilt bed rest (HDBR) would reduce bone resorption and increase bone formation compared to nonsupplemented controls. METHODS This exploratory randomized, controlled, single-blind intervention study conducted in a parallel design included 20 healthy male volunteers (age, 34 ± 8 years; weight, 74 ± 6 kg). The study consisted of a 14-day adaptation phase [baseline data collection (BDC)], followed by 60 days of HDBR and a 14-day recovery period (R). In the antioxidant group, volunteers received an antioxidant cocktail (741 mg/d polyphenols, 2.1 g/d omega-3 fatty acids, 168 mg/d vitamin E, and 80 μg/d selenium) with their daily meals. In the control group, volunteers received no supplement. Based on their body weight, all volunteers received an individually tailored and strictly controlled diet, consistent with DRIs. We analyzed biomarkers of calcium homeostasis, bone formation, and bone resorption during BDC, HDBR, and R, as well as for 30 days after the end of HDBR. Data were analyzed by linear mixed models. RESULTS The antioxidant supplement did not affect serum calcium, parathyroid hormone, urinary C-telopeptide of type I collagen (CTX), urinary N-telopeptide of type I collagen, serum β-C-telopeptide of type I collagen (β-CTX), bone alkaline phosphatase, aminoterminal propeptide of type I collagen, osteocalcin, or urinary calcium excretion. In both groups, typical bed rest-related changes were observed. CONCLUSIONS Supplementation of an antioxidant cocktail to a diet matching the DRIs did not affect bone resorption or formation during 60 days of HDBR in healthy young men. This trial was registered at clinicaltrials.gov as NCT03594799.",2021,"The antioxidant supplement did not affect serum calcium, parathyroid hormone, urinary C-telopeptide of type","['20 healthy male volunteers (age, 34\xa0± 8 years; weight, 74\xa0± 6\xa0kg', 'healthy young men']","['Antioxidant Supplementation', 'antioxidant supplementation', 'Antioxidants like polyphenols, omega-3 fatty acids, vitamins, and micronutrients', '6° Head-Down Tilt Bed Rest', '14-day adaptation phase [baseline data collection (BDC', 'antioxidant cocktail (741\xa0mg/d polyphenols, 2.1\xa0g/d omega-3 fatty acids, 168\xa0mg/d vitamin E, and 80\xa0μg/d selenium) with their daily meals']","['bone resorption and increase bone formation', 'serum calcium, parathyroid hormone, urinary C-telopeptide of type', 'I collagen (β-CTX), bone alkaline phosphatase, aminoterminal propeptide of type I collagen, osteocalcin, or urinary calcium excretion', 'bone resorption or formation', 'Bone Turnover Markers', 'serum β-C-telopeptide of type', 'calcium homeostasis, bone formation, and bone resorption during BDC, HDBR, and R', 'urinary N-telopeptide of type']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0242683', 'cui_str': 'Head-Down Tilt'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0678420', 'cui_str': 'Cocktail'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0699812', 'cui_str': 'Increased bone formation'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0312399', 'cui_str': 'Alkaline phosphatase isoenzyme, bone fraction'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C3653518', 'cui_str': 'CALCIUM HOMEOSTASIS'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0242683', 'cui_str': 'Head-Down Tilt'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}]",20.0,0.116727,"The antioxidant supplement did not affect serum calcium, parathyroid hormone, urinary C-telopeptide of type","[{'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Austermann', 'Affiliation': 'Nutritional Physiology, Institute of Nutritional and Food Sciences, Rheinische Friedrich-Wilhelms-Universität Bonn, Bonn, Germany.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Baecker', 'Affiliation': 'IUBH International University of Applied Sciences, Bad Reichenhall, Germany.'}, {'ForeName': 'Sara R', 'Initials': 'SR', 'LastName': 'Zwart', 'Affiliation': 'Department of Preventive Medicine and Community Health, The University of Texas Medical Branch at Galveston, Galveston, TX, USA.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Fimmers', 'Affiliation': 'Department of Medical Biometry, Rheinische Friedrich-Wilhelms-Universität Bonn, Bonn, Germany.'}, {'ForeName': 'Jean-Pol', 'Initials': 'JP', 'LastName': 'Frippiat', 'Affiliation': 'Stress, Immunity, Pathogens Laboratory, Lorraine University, Nancy, France.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Stehle', 'Affiliation': 'Nutritional Physiology, Institute of Nutritional and Food Sciences, Rheinische Friedrich-Wilhelms-Universität Bonn, Bonn, Germany.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Smith', 'Affiliation': 'Human Health and Performance Directorate, National Aeronautics and Space Administration Johnson Space Center, Houston, TX, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Heer', 'Affiliation': 'Nutritional Physiology, Institute of Nutritional and Food Sciences, Rheinische Friedrich-Wilhelms-Universität Bonn, Bonn, Germany.'}]",The Journal of nutrition,['10.1093/jn/nxab036'] 3213,33831942,Bladder Instillations With Triamcinolone Acetonide for Interstitial Cystitis-Bladder Pain Syndrome: A Randomized Controlled Trial.,"OBJECTIVE To evaluate the utility of adding triamcinolone acetonide to a standard bladder instillation solution for treatment of interstitial cystitis-bladder pain syndrome. METHODS This was a single-center, randomized, double-blind trial that compared symptom response in women with interstitial cystitis-bladder pain syndrome who underwent six bladder instillations with triamcinolone acetonide or six instillations without. All instillation solutions contained heparin, viscous lidocaine, sodium bicarbonate, and bupivacaine. The primary outcome was the change in interstitial cystitis-bladder pain syndrome symptoms from the first to sixth bladder instillation between groups based on the total OLS (O'Leary-Sant Questionnaire) score. Assuming a 4.03-point or larger difference in the mean total OLS score from the first to sixth bladder instillation as compared between the groups, 64 participants were needed to show a significant difference with 80% power at the 0.05 significance level. RESULTS From January 2019 to October 2020, 90 women were enrolled-45 per group; 71 (79%) completed all six bladder instillations. Randomization resulted in groups with similar characteristics. There was no difference between groups in the primary outcome (bladder instillation with triamcinolone acetonide: mean OLS change -6.7 points, 95% CI 4.6-8.8 and bladder instillation without triamcinolone acetonide: mean OLS change -5.8 points, 95% CI 3.4-8.1; P=.31). Women in both groups had improvement in their interstitial cystitis-bladder pain syndrome symptoms as indicated by a decrease in the total OLS score from the first to sixth bladder instillation. CONCLUSION The addition of triamcinolone acetonide to a standard bladder instillation solution does not improve symptoms associated with interstitial cystitis-bladder pain syndrome. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, NCT03463915.",2021,There was no difference between groups in the primary outcome (bladder instillation with triamcinolone acetonide:,"['Interstitial Cystitis-Bladder Pain Syndrome', 'interstitial cystitis-bladder pain syndrome', 'women with interstitial cystitis-bladder pain syndrome who underwent six bladder instillations with', 'From January 2019 to October 2020, 90 women were enrolled-45 per group; 71 (79%) completed all six bladder instillations']","['Triamcinolone Acetonide', 'heparin, viscous lidocaine, sodium bicarbonate, and bupivacaine', 'triamcinolone acetonide', 'triamcinolone acetonide or six instillations without']","['change in interstitial cystitis-bladder pain syndrome symptoms', 'mean total OLS score', 'interstitial cystitis-bladder pain syndrome symptoms', ""total OLS (O'Leary-Sant Questionnaire) score"", 'total OLS score']","[{'cui': 'C0282488', 'cui_str': 'Ulcerative cystitis'}, {'cui': 'C1720830', 'cui_str': 'Bladder Pain Syndrome'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021917', 'cui_str': 'Instillation of bladder'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0282488', 'cui_str': 'Ulcerative cystitis'}, {'cui': 'C1720830', 'cui_str': 'Bladder Pain Syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",90.0,0.28415,There was no difference between groups in the primary outcome (bladder instillation with triamcinolone acetonide:,"[{'ForeName': 'Olivia O', 'Initials': 'OO', 'LastName': 'Cardenas-Trowers', 'Affiliation': ""Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics, Gynecology, and Women's Health, University of Louisville School of Medicine, the University of Louisville School of Medicine, and the Department of Bioinformatics and Biostatistics, University of Louisville School of Public Health and Information Sciences, Louisville, Kentucky.""}, {'ForeName': 'Alyce G', 'Initials': 'AG', 'LastName': 'Abraham', 'Affiliation': ''}, {'ForeName': 'Thomas K', 'Initials': 'TK', 'LastName': 'Dotson', 'Affiliation': ''}, {'ForeName': 'Brooke A', 'Initials': 'BA', 'LastName': 'Houlette', 'Affiliation': ''}, {'ForeName': 'Jeremy T', 'Initials': 'JT', 'LastName': 'Gaskins', 'Affiliation': ''}, {'ForeName': 'Sean L', 'Initials': 'SL', 'LastName': 'Francis', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004348'] 3214,33831935,Pretreatment With Mifepristone Compared With Misoprostol Alone for Delivery After Fetal Death Between 14 and 28 Weeks of Gestation: A Randomized Controlled Trial.,"OBJECTIVE To assess the efficacy of pretreatment with mifepristone before misoprostol, compared with misoprostol alone, for termination of pregnancy after a fetal death in the second trimester. METHODS This prospective, double blind, placebo-controlled trial randomized women requiring a termination of pregnancy after fetal death between 14 and 28 weeks of gestation to placebo or 200 mg mifepristone orally 24-48 hours before the termination of pregnancy with misoprostol (400 micrograms every 6 hours vaginally for women at 24 weeks of gestation or less, and 200 micrograms every 4 hours vaginally for women at 24 weeks of gestation or more). Based on a median labor with misoprostol alone in the second trimester of 13 hours, a sample size of 116 women per group was planned to compare the primary outcome of time from administration of misoprostol to delivery. The trial was ceased after 66 women were enrolled secondary to prolonged time to achieve recruitment. RESULTS From April 2013 to November 2016, 66 women were randomized (34 to placebo and 32 to mifepristone). There were no differences in the characteristics between the two groups. The median time for the primary outcome of administration of misoprostol to delivery in the placebo group was 10.5 hours, compared with 6.8 hours in the treatment group (hazard ratio 2.41 95% CI 1.39-4.17, P=.002). Women in the placebo group required more doses of misoprostol (3.4 vs 2.1, P=.002) and more misoprostol overall (1,181.8 micrograms, vs 767.7 micrograms, P=.003). There was no difference in maternal complications between the two groups. Women in the mifepristone group reported improved perception of the procedure. CONCLUSION The sequential use of mifepristone and misoprostol for the termination of pregnancy after fetal deaths between 14 and 28 weeks of gestation reduces the time to delivery, compared with the use of misoprostol alone, with no worsening of maternal complications. CLINICAL TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry, ACTRN12612000884808.",2021,There was no difference in maternal complications between the two groups.,"['orally 24-48 hours before the termination of pregnancy with', 'women requiring a termination of pregnancy after fetal death between 14 and 28 weeks of gestation to', 'From April 2013 to November 2016, 66 women were randomized (34 to', '66 women were enrolled secondary to prolonged time to achieve recruitment']","['Misoprostol', 'mifepristone before misoprostol', 'misoprostol', 'mifepristone and misoprostol', 'Mifepristone', 'placebo', 'placebo or 200 mg mifepristone', 'mifepristone']","['maternal complications', 'median time', 'perception of the procedure']","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0392535', 'cui_str': 'Termination of pregnancy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015927', 'cui_str': 'Fetal death'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}]","[{'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",66.0,0.623023,There was no difference in maternal complications between the two groups.,"[{'ForeName': 'Emma R', 'Initials': 'ER', 'LastName': 'Allanson', 'Affiliation': 'Division of Obstetrics and Gynaecology, University of Western Australia, Perth, the Institute for Health Research, University of Notre Dame, Fremantle, King Edward Memorial Hospital, Perth, Western Australia, and the Office of the Chief Nurse and Midwife, Department of Health, Northern Territory Government, Darwin, Northern Territory, Australia.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Copson', 'Affiliation': ''}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Spilsbury', 'Affiliation': ''}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Criddle', 'Affiliation': ''}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Jennings', 'Affiliation': ''}, {'ForeName': 'Dorota A', 'Initials': 'DA', 'LastName': 'Doherty', 'Affiliation': ''}, {'ForeName': 'Antonia M', 'Initials': 'AM', 'LastName': 'Wong', 'Affiliation': ''}, {'ForeName': 'Jan E', 'Initials': 'JE', 'LastName': 'Dickinson', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004344'] 3215,33831843,Effect of Warm-Up and Sodium Bicarbonate Ingestion on 4-km Cycling Time-Trial Performance.,"PURPOSE To examine whether an ecologically valid, intermittent, sprint-based warm-up strategy impacted the ergogenic capacity of individualized sodium bicarbonate (NaHCO3) ingestion on 4-km cycling time-trial (TT) performance. METHODS A total of 8 male cyclists attended 6 laboratory visits for familiarization, determination of time to peak blood bicarbonate, and 4 × 4-km cycling TTs. Experimental beverages were administered doubleblind. Treatments were conducted in a block-randomized, crossover order: intermittent warm-up + NaHCO3 (IWSB), intermittent warm-up + placebo, control warm-up + NaHCO3 (CWSB), and control warm-up + placebo (CWP). The intermittent warm-up comprised exercise corresponding to lactate threshold (5 min at 50%, 2 min at 60%, 2 min at 80%, 1 min at 100%, and 2 min at 50%) and 3 × 10-second maximal sprints. The control warm-up comprised 16.5 minutes cycling at 150 W. Participants ingested 0.3 g·kg body mass-1 NaHCO3 or 0.03 g·kg body mass-1 sodium chloride (placebo) in 5 mL·kg body mass-1 fluid (3:2, water and sugar-free orange squash). Paired t tests were conducted for TT performance. Hematological data (blood bicarbonate and blood lactate) and gastrointestinal discomfort were analyzed using repeated-measures analysis of variance. RESULTS Performance was faster for CWSB versus IWSB (5.0 [6.1] s; P = .052) and CWP (5.8 [6.0] s; P = .03). Pre-TT bicarbonate concentration was elevated for CWSB versus IWSB (+9.3 mmol·L-1; P < .001) and CWP (+7.1 mmol·L-1; P < .001). Post-TT blood lactate concentration was elevated for CWSB versus CWP (+2.52 mmol·L-1; P = .022). Belching was exacerbated pre-warm-up for IWSB versus intermittent warm-up +placebo (P = .046) and CWP (P = .027). CONCLUSION An intermittent, sprint-based warm-up mitigated the ergogenic benefits of NaHCO3 ingestion on 4-km cycling TT performance.",2021,"Belching was exacerbated pre-warm-up for IWSB versus intermittent warm-up +placebo (P = .046) and CWP (P = .027). CONCLUSION ","['8 male cyclists attended 6 laboratory visits for familiarization, determination of time to peak blood bicarbonate, and 4 × 4-km cycling TTs']","['individualized sodium bicarbonate (NaHCO3) ingestion', 'Warm-Up and Sodium Bicarbonate Ingestion', 'IWSB versus intermittent warm-up +placebo', 'intermittent warm-up comprised exercise corresponding to lactate threshold', 'control warm-up comprised 16.5\xa0minutes cycling at 150\xa0W. Participants ingested 0.3\xa0g·kg body mass-1 NaHCO3 or 0.03\xa0g·kg body mass-1 sodium chloride (placebo', 'intermittent warm-up + NaHCO3 (IWSB), intermittent warm-up + placebo, control warm-up + NaHCO3 (CWSB), and control warm-up + placebo (CWP']","['4-km cycling time-trial (TT) performance', 'Hematological data (blood bicarbonate and blood lactate) and gastrointestinal discomfort', 'Post-TT blood lactate concentration', 'Belching', 'TT bicarbonate concentration', 'CWP']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0853263', 'cui_str': 'Blood bicarbonate'}]","[{'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517402', 'cui_str': '0.03'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0853263', 'cui_str': 'Blood bicarbonate'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C1096250', 'cui_str': 'Gastrointestinal discomfort'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0014724', 'cui_str': 'Eructation'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",8.0,0.0891105,"Belching was exacerbated pre-warm-up for IWSB versus intermittent warm-up +placebo (P = .046) and CWP (P = .027). CONCLUSION ","[{'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Gurton', 'Affiliation': ''}, {'ForeName': 'Steve H', 'Initials': 'SH', 'LastName': 'Faulkner', 'Affiliation': ''}, {'ForeName': 'Ruth M', 'Initials': 'RM', 'LastName': 'James', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2020-0743'] 3216,33831805,A comparison of kinesio taping and classical massage in addition to cervical stabilization exercise in patients with chronic neck pain.,"BACKGROUND AND PURPOSE Studies comparing the effectiveness of kinesio taping (KT) and classical massage (CM) in chronic neck pain (CNP) are scarce. This study aimed to compare the effects of KT and CM in addition to cervical stabilization exercise (CSE) in patients with CNP. MATERIALS AND METHODS Patients were randomly allocated to KT + CSE and CM + CSE groups. Disability with the Neck Disability Index (NDI), pain with the Visual Analog Scale, cervical range of motion with a goniometer, and quality of life (QoL) with the 36-Item Short-Form (SF-36) were assessed baseline and after a 4-week treatment. RESULTS Improvement was observed in NDI and physical component scores of SF-36 in favor of the KT + CSE group and in rotation movements in favor of the CM + CSE group (p < 0.05). CONCLUSION In CNP, KT + CSE was superior in improving disability and QoL compared to CM + CSE, whereas CM + CSE was superior in increasing rotation movements compared to KT + CSE.",2021,"RESULTS Improvement was observed in NDI and physical component scores of SF-36 in favor of the KT + CSE group and in rotation movements in favor of the CM + CSE group (p < 0.05). ","['Patients', 'patients with CNP', 'chronic neck pain (CNP', 'patients with chronic neck pain']","['KT\xa0+\xa0CSE and CM\xa0+\xa0CSE', 'kinesio taping (KT) and classical massage (CM', 'cervical stabilization exercise (CSE', 'cervical stabilization exercise', 'KT and CM', 'kinesio taping and classical massage']","['NDI and physical component scores of SF-36', 'disability and QoL', 'rotation movements', 'Disability with the Neck Disability Index (NDI), pain with the Visual Analog Scale, cervical range of motion with a goniometer, and quality of life (QoL) with the 36-Item Short-Form (SF-36']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}]","[{'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]",,0.0404952,"RESULTS Improvement was observed in NDI and physical component scores of SF-36 in favor of the KT + CSE group and in rotation movements in favor of the CM + CSE group (p < 0.05). ","[{'ForeName': 'Seyda', 'Initials': 'S', 'LastName': 'Toprak Celenay', 'Affiliation': 'Ankara Yildirim Beyazit University, Health Sciences Faculty, Department of Physiotherapy and Rehabilitation, Ankara, Turkey. Electronic address: sydtoprak@hotmail.com.'}, {'ForeName': 'Oguzhan', 'Initials': 'O', 'LastName': 'Mete', 'Affiliation': 'Ankara Yildirim Beyazit University, Health Sciences Faculty, Department of Physiotherapy and Rehabilitation, Ankara, Turkey. Electronic address: fztoguzhanmete06@gmail.com.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Sari', 'Affiliation': 'Vakfıkebir State Hospital, Department of Physiotherapy and Rehabilitation, Trabzon, Turkey. Electronic address: fizyoterapistabdullah@gmail.com.'}, {'ForeName': 'Derya', 'Initials': 'D', 'LastName': 'Ozer Kaya', 'Affiliation': 'Izmir Katip Celebi University, Health Sciences Faculty, Department of Physiotherapy and Rehabilitation, Izmir, Turkey. Electronic address: deryaozer2000@yahoo.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101381'] 3217,33831803,"Effects of laughter yoga on hemodialysis patients' plasma-beta endorphin levels, pain levels and sleep quality: A randomized controlled trial.","This study evaluates the effects of ""laughter yoga"" on the plasma beta-endorphin levels, pain levels and sleep quality of hemodialysis patients. It is a randomized controlled trial. The study was carried out between July and October 2018. A total of 68 patients receiving hemodialysis treatment at two different dialysis centers were included in the study. The duration of the laughter yoga was 30 min, and a total of 16 sessions were performed on a twice-weekly basis. The data were collected by using a socio-demographic information form, the Visual Analog Scale and the Pittsburgh Sleep Quality Index, and blood samples were collected to determine beta-endorphin levels. Following the laughter yoga implementation, the pain level of the intervention group patients significantly decreased, and their sleep quality significantly improved. No significant change occurred in the patients' beta-endorphin levels. Laughter yoga was effective in reducing pain and increasing sleep quality.",2021,No significant change occurred in the patients' beta-endorphin levels.,"['hemodialysis patients', '68 patients receiving hemodialysis treatment at two different dialysis centers were included in the study']","['laughter yoga', 'Laughter yoga']","['Visual Analog Scale and the Pittsburgh Sleep Quality Index, and blood samples', 'sleep quality', 'pain and increasing sleep quality', 'pain level', ""patients' beta-endorphin levels"", ""hemodialysis patients' plasma-beta endorphin levels, pain levels and sleep quality"", 'plasma beta-endorphin levels, pain levels and sleep quality']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4045984', 'cui_str': 'Laughter Yoga'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0917799', 'cui_str': 'Hypersomnia'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005210', 'cui_str': 'Beta endorphin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",68.0,0.0279161,No significant change occurred in the patients' beta-endorphin levels.,"[{'ForeName': 'Zülfünaz', 'Initials': 'Z', 'LastName': 'Özer', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Istanbul Sabahattin Zaim University, Istanbul, Turkey. Electronic address: zulfinazozer@gmail.com.'}, {'ForeName': 'Sebahat', 'Initials': 'S', 'LastName': 'Ateş', 'Affiliation': 'School of Nursing, Maltepe University, İstanbul, Turkey. Electronic address: sebahatates@maltepe.edu.tr.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101382'] 3218,33831770,"Add on yoga treatment for negative symptoms of schizophrenia: A multi-centric, randomized controlled trial.","The efficacy of antipsychotic medications in the treatment of negative symptoms of schizophrenia is modest at best. Preliminary studies suggest the beneficial effects of add on Yoga, a traditional Indian practice, in the treatment of schizophrenia. Hence, in this study, we examined the efficacy of yoga as an add-on treatment for negative symptoms of schizophrenia in a randomized, wait-list controlled design from two clinical institutes in south India. 89 patients (age - 34.20 ± 8.06 years; education - 14.22 ± 2.69 years; 28 females) were randomized into the add-on yoga or treatment as usual (TAU - wait-list control) group. Patients had a mean illness duration of 10.97 ± 7.24 years with an age at onset of 23.34 ± 5.81 years. Central block randomization was followed to ensure concealed allocation. Participants randomized to the yoga treatment group attended 12 supervised yoga training sessions over two weeks and practiced yoga sessions at home for the subsequent 10 weeks. 64 patients completed the trial. An intent to treat analysis was conducted with 89 participants using a linear mixed model. Improvement in negative symptoms was our primary outcome measure. The two groups were matched on demographic variables and baseline psychopathology severity. Participants in the add-on yoga group had significantly greater improvement in negative symptoms (SANS baseline: 49.13 ± 2.30; 12-weeks follow up: 31.55 ± 2.53) compared to the TAU group (SANS baseline: 51.22 ± 2.40; 12-weeks follow up: 45.30 ± 2.93; t = 3.36; p = 0.006; Cohen's d-0.65). The current study findings suggest the efficacy of yoga as an add-on treatment for negative symptoms of schizophrenia. The effectiveness of yoga practice as a regular clinical intervention for patients needs to be explored in future studies by integrating yoga services along with other clinical services.",2021,Participants in the add-on yoga group had significantly greater improvement in negative symptoms (SANS baseline: 49.13 ± 2.30; 12-weeks follow up: 31.55 ± 2.53) compared to the TAU group (SANS baseline: 51.22 ± 2.40; 12-weeks follow up: 45.30 ± 2.93; t = 3.36; p = 0.006; Cohen's d-0.65).,"['negative symptoms of schizophrenia', 'two clinical institutes in south India', '89 patients (age - 34.20 ± 8.06 years; education - 14.22 ± 2.69 years; 28 females', '89 participants using a linear mixed model', 'Patients had a mean illness duration of 10.97 ± 7.24 years with an age at onset of 23.34 ± 5.81 years', '64 patients completed the trial']","['on yoga or treatment as usual (TAU - wait-list control', 'antipsychotic medications', 'yoga treatment group attended 12 supervised yoga training sessions', 'yoga treatment']",['negative symptoms'],"[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",89.0,0.0937125,Participants in the add-on yoga group had significantly greater improvement in negative symptoms (SANS baseline: 49.13 ± 2.30; 12-weeks follow up: 31.55 ± 2.53) compared to the TAU group (SANS baseline: 51.22 ± 2.40; 12-weeks follow up: 45.30 ± 2.93; t = 3.36; p = 0.006; Cohen's d-0.65).,"[{'ForeName': 'Naren P', 'Initials': 'NP', 'LastName': 'Rao', 'Affiliation': 'National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, India. Electronic address: narenrao@nimhans.ac.in.'}, {'ForeName': 'Padmavati', 'Initials': 'P', 'LastName': 'Ramachandran', 'Affiliation': 'Schizophrenia Research Foundation (SCARF), Chennai, India.'}, {'ForeName': 'Arpitha', 'Initials': 'A', 'LastName': 'Jacob', 'Affiliation': 'National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Joseph', 'Affiliation': 'Schizophrenia Research Foundation (SCARF), Chennai, India.'}, {'ForeName': 'Umesh', 'Initials': 'U', 'LastName': 'Thonse', 'Affiliation': 'National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Bhargavi', 'Initials': 'B', 'LastName': 'Nagendra', 'Affiliation': 'National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Dona M', 'Initials': 'DM', 'LastName': 'Chako', 'Affiliation': 'National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Sahana', 'Initials': 'S', 'LastName': 'Shiri', 'Affiliation': 'National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Habla', 'Initials': 'H', 'LastName': 'Hassan', 'Affiliation': 'National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Vamsi', 'Initials': 'V', 'LastName': 'Sreenivas', 'Affiliation': 'Schizophrenia Research Foundation (SCARF), Chennai, India.'}, {'ForeName': 'Sindhu', 'Initials': 'S', 'LastName': 'Maran', 'Affiliation': 'Schizophrenia Research Foundation (SCARF), Chennai, India.'}, {'ForeName': 'Dwarakanath', 'Initials': 'D', 'LastName': 'Durgam', 'Affiliation': 'Schizophrenia Research Foundation (SCARF), Chennai, India.'}, {'ForeName': 'Kiruthika', 'Initials': 'K', 'LastName': 'Nandakumar', 'Affiliation': 'Schizophrenia Research Foundation (SCARF), Chennai, India.'}, {'ForeName': 'Shivarama', 'Initials': 'S', 'LastName': 'Varambally', 'Affiliation': 'National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Bangalore N', 'Initials': 'BN', 'LastName': 'Gangadhar', 'Affiliation': 'National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, India.'}]",Schizophrenia research,['10.1016/j.schres.2021.03.021'] 3219,33831589,Intrapartum opioid analgesia and childhood neurodevelopmental outcomes among infants born preterm.,"BACKGROUND There are concerns regarding neurobehavioral changes in infants exposed to parenteral opioids during labor, yet long-term neurodevelopment remains unstudied. OBJECTIVE We aimed to examine the association between parenteral opioids for labor analgesia and perinatal outcomes and childhood neurodevelopment until two years of age among infants born preterm. We hypothesized that intrapartum exposure to parenteral opioids is associated with impaired neurodevelopment and adverse perinatal outcomes. STUDY DESIGN Secondary analysis of a multicenter randomized controlled trial assessing magnesium for prevention of cerebral palsy in infants at risk for preterm birth. Women delivering a singleton, non-anomalous, live infant prior to 37 weeks gestation were considered for inclusion. Women were excluded if they were missing exposure or primary outcome data, were exposed to general anesthesia, or reported use of heroin or unspecified illicit drugs. Women reporting use of non-opioid illicit drugs such as cocaine and marijuana were not excluded. Groups were compared based on exposure or non-exposure to parenteral opioids (intravenous or intramuscular) for labor analgesia. The primary outcome was any psychomotor or mental developmental delay at 24 months by Bayley Scales of Infant Development II. Secondary outcomes were BSID subdomains and adverse perinatal outcomes. Multivariable logistic regression models were performed and adjusted odds ratios with 95% confidence intervals were estimated. RESULTS Of 1,404 women included, 535 (38%) received parenteral opioids for labor analgesia. Women receiving parenteral opioids were more likely to be younger, Hispanic, and present with cervical dilation ≥4cm. Parenteral opioid recipients had lower rates of illicit non-opioid drug or tobacco use, a lower rate of cesarean delivery, lower educational achievement, and were less likely to be undergoing induction. Women receiving parenteral opioids who underwent cesarean delivery were less likely to do so due to non-reassuring fetal status. In unadjusted and adjusted analyses, there were no significant differences in the primary outcome of psychomotor or mental developmental delay at two years of age (aOR 0.96, CI 0.76-1.20). The only significant difference in secondary outcomes was a shorter oxygen requirement duration in the parenteral opioid group (2 vs. 4 days, p=0.002). CONCLUSION Among a population of preterm infants vulnerable to neurologic impairment, intrapartum exposure to parenteral opioids was not associated with an increased risk of neurodevelopmental delay up to two years of age, nor did these infants have worse perinatal outcomes.",2021,"intrapartum exposure to parenteral opioids was not associated with an increased risk of neurodevelopmental delay up to two years of age, nor did these infants have worse perinatal outcomes.","['childhood neurodevelopment until two years of age among infants born preterm', 'Of 1,404 women included, 535 (38%) received', 'Women were excluded if they were missing exposure or primary outcome data, were exposed to general anesthesia, or reported use of heroin or unspecified illicit drugs', 'infants born preterm', 'infants at risk for preterm birth']","['Intrapartum opioid analgesia', 'parenteral opioids (intravenous or intramuscular) for labor analgesia', 'parenteral opioids', 'magnesium']","['rates of illicit non-opioid drug or tobacco use, a lower rate of cesarean delivery, lower educational achievement', 'psychomotor or mental developmental delay at 24 months by Bayley Scales of Infant Development II', 'risk of neurodevelopmental delay', 'psychomotor or mental developmental delay', 'shorter oxygen requirement duration', 'BSID subdomains and adverse perinatal outcomes']","[{'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0086190', 'cui_str': 'Drugs, Illegal'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}]","[{'cui': 'C0456337', 'cui_str': 'Intrapartum'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C1301740', 'cui_str': 'Analgesia in labor'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}]","[{'cui': 'C0332266', 'cui_str': 'Illicit'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C0424605', 'cui_str': 'Developmental delay'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0451021', 'cui_str': 'Bayley scale of infant development'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",1404.0,0.238281,"intrapartum exposure to parenteral opioids was not associated with an increased risk of neurodevelopmental delay up to two years of age, nor did these infants have worse perinatal outcomes.","[{'ForeName': 'Lindsay S', 'Initials': 'LS', 'LastName': 'Robbins', 'Affiliation': ""Center for Women's Reproductive Health, University of Alabama at Birmingham; Department of Obstetrics and Gynecology, University of Alabama at Birmingham. Electronic address: lsrobbins@uabmc.edu.""}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Perez', 'Affiliation': ""Center for Women's Reproductive Health, University of Alabama at Birmingham; Department of Obstetrics and Gynecology, University of Alabama at Birmingham.""}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Casey', 'Affiliation': ""Center for Women's Reproductive Health, University of Alabama at Birmingham; Department of Obstetrics and Gynecology, University of Alabama at Birmingham.""}, {'ForeName': 'Ms Christina T', 'Initials': 'MCT', 'LastName': 'Blanchard', 'Affiliation': ""Center for Women's Reproductive Health, University of Alabama at Birmingham.""}, {'ForeName': 'Alan T', 'Initials': 'AT', 'LastName': 'Tita', 'Affiliation': ""Center for Women's Reproductive Health, University of Alabama at Birmingham; Department of Obstetrics and Gynecology, University of Alabama at Birmingham.""}, {'ForeName': 'Lorie M', 'Initials': 'LM', 'LastName': 'Harper', 'Affiliation': ""Center for Women's Reproductive Health, University of Alabama at Birmingham; Department of Obstetrics and Gynecology, University of Alabama at Birmingham.""}]",American journal of obstetrics & gynecology MFM,['10.1016/j.ajogmf.2021.100372'] 3220,33831566,Multiple-day high-dose beetroot juice supplementation does not improve pulmonary or muscle deoxygenation kinetics of well-trained cyclists in normoxia and hypoxia.,"Dietary nitrate (NO 3 - ) supplementation via beetroot juice (BR) has been reported to lower oxygen cost (i.e., increased exercise efficiency) and speed up oxygen uptake (VO 2 ) kinetics in untrained and moderately trained individuals, particularly during conditions of low oxygen availability (i.e., hypoxia). However, the effects of multiple-day, high dose (12.4 mmol NO - 3 per day) BR supplementation on exercise efficiency and VO 2 kinetics during normoxia and hypoxia in well-trained individuals are not resolved. In a double-blinded, randomized crossover study, 12 well-trained cyclists (66.4 ± 5.3 ml min -1 ∙kg -1 ) completed three transitions from rest to moderate-intensity (∼70% of gas exchange threshold) cycling in hypoxia and normoxia with supplementation of BR or nitrate-depleted BR as placebo. Continuous measures of VO 2 and muscle (vastus lateralis) deoxygenation (ΔHHb, using near-infrared spectroscopy) were acquired during all transitions. Kinetics of VO 2 and deoxygenation (ΔHHb) were modelled using mono-exponential functions. Our results showed that BR supplementation did not alter the primary time constant for VO 2 or ΔHHb during the transition from rest to moderate-intensity cycling. While BR supplementation lowered the amplitude of the VO 2 response (2.1%, p=0.038), BR did not alter steady state VO 2 derived from the fit (p=0.258), raw VO 2 data (p=0.231), moderate intensity exercise efficiency (p=0.333) nor steady state ΔHHb (p=0.224). Altogether, these results demonstrate that multiple-day, high-dose BR supplementation does not alter exercise efficiency or oxygen uptake kinetics during normoxia and hypoxia in well-trained athletes.",2021,"While BR supplementation lowered the amplitude of the VO 2 response (2.1%, p=0.038), BR did not alter steady state VO 2 derived from the fit (p=0.258), raw VO 2 data (p=0.231), moderate intensity exercise efficiency (p=0.333) nor steady state ΔHHb (p=0.224).",['12 well-trained cyclists (66.4 ± 5.3 ml min -1 ∙kg -1 ) completed three'],"['Dietary nitrate (NO 3 - ) supplementation via beetroot juice (BR', 'transitions from rest to moderate-intensity (∼70% of gas exchange threshold) cycling in hypoxia and normoxia with supplementation of BR or nitrate-depleted BR as placebo', 'BR supplementation']","['exercise efficiency) and speed up oxygen uptake (VO 2 ) kinetics', 'Kinetics of VO 2 and deoxygenation (ΔHHb', 'pulmonary or muscle deoxygenation kinetics', 'exercise efficiency or oxygen uptake kinetics', 'moderate intensity exercise efficiency', 'VO 2 and muscle (vastus lateralis) deoxygenation (ΔHHb, using near-infrared spectroscopy', 'amplitude of the VO 2 response']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C1301862', 'cui_str': 'Min 1'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}]",12.0,0.160861,"While BR supplementation lowered the amplitude of the VO 2 response (2.1%, p=0.038), BR did not alter steady state VO 2 derived from the fit (p=0.258), raw VO 2 data (p=0.231), moderate intensity exercise efficiency (p=0.333) nor steady state ΔHHb (p=0.224).","[{'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Rokkedal-Lausch', 'Affiliation': 'Sport Sciences - Performance and Technology, Department of Health Science and Technology, Aalborg University, DK-9220, Aalborg, Denmark. Electronic address: torben@hst.aau.dk.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Franch', 'Affiliation': 'Sport Sciences - Performance and Technology, Department of Health Science and Technology, Aalborg University, DK-9220, Aalborg, Denmark.'}, {'ForeName': 'Mathias K', 'Initials': 'MK', 'LastName': 'Poulsen', 'Affiliation': 'Respiratory and Critical Care Group, Department of Health Science and Technology, Aalborg University, DK-9220, Aalborg, Denmark.'}, {'ForeName': 'Lars P', 'Initials': 'LP', 'LastName': 'Thomsen', 'Affiliation': 'Respiratory and Critical Care Group, Department of Health Science and Technology, Aalborg University, DK-9220, Aalborg, Denmark.'}, {'ForeName': 'Eddie', 'Initials': 'E', 'LastName': 'Weitzberg', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, 171 77, Stockholm, Sweden.'}, {'ForeName': 'Ernest N', 'Initials': 'EN', 'LastName': 'Kamavuako', 'Affiliation': ""Center for Robotics Research, Department of Engineering, King's College London, London, United Kingdom.""}, {'ForeName': 'Dan S', 'Initials': 'DS', 'LastName': 'Karbing', 'Affiliation': 'Respiratory and Critical Care Group, Department of Health Science and Technology, Aalborg University, DK-9220, Aalborg, Denmark.'}, {'ForeName': 'Ryan G', 'Initials': 'RG', 'LastName': 'Larsen', 'Affiliation': 'Sport Sciences - Performance and Technology, Department of Health Science and Technology, Aalborg University, DK-9220, Aalborg, Denmark.'}]",Nitric oxide : biology and chemistry,['10.1016/j.niox.2021.03.006'] 3221,33831552,Exenatide twice daily plus glargine vs. aspart 70/30 twice daily in type 2 diabetic patients with inadequate glycaemic control on premixed human insulin and metformin.,"BACKGROUND Many type 2 diatetic patients treated with premixed insulin gradually have inadequate glycaemic control and switch to a basal-bolus regimen, which raises some concerns for weight gain and increased hypoglycaemic risk. Switching to combination use of glp-1 agonist and basal insulin may be an alternative option. METHODS After a 12-week premixed human insulin 70/30 dosage optimization period, 200 patients with HbA1c of 7.0% to 10.0% were randomized into 24-week treatment groups with exenatide BID plus glargine or with aspart 70/30 BID. RESULTS After 24 weeks, the patients receiving exenatide plus glargine (n = 90) had improved HbA1c control compared with those receiving aspart 70/30 (n = 90) (least squares mean change: -0.59 vs. -0.13%; difference [95% CI]: -0.45 [-0.74 to -0.17]) in the full analysis set population. Weight decreased 3.5 kg with exenatide and decreased 0.4 kg with aspart 70/30 (P < 0.001). The insulin dose was reduced 10.7 units/day (95% CI, -12.2 to -9.2 units; P < 0.001) with exenatide, and increased 9.7 units/day (95% CI, 8.2 to 11.2 units; P < 0.001) with aspart 70/30. The most common adverse events were gastrointestinal adverse effects in the exenatide group [nausea (21%), vomiting (16%), diarrhea (13%)]. The incidence of hypoglycaemia was similar in two groups (27% for exenatide and 38% for aspart 70/30, respectively; P = 0.1). CONCLUSIONS In premixed human insulin-treated type 2 diabetic patients with inadequate glycaemic control, switching to exenatide BID plus glargine was superior to aspart 70/30 BID for glycaemic and weight control.",2021,"The incidence of hypoglycaemia was similar in two groups (27% for exenatide and 38% for aspart 70/30, respectively; P = 0.1). ","['200 patients with HbA1c of 7.0% to 10.0', 'type 2 diabetic patients with inadequate glycaemic control on premixed human insulin and', '2 diabetic patients with inadequate glycaemic control']","['Exenatide twice daily plus glargine vs. aspart', 'premixed human insulin-treated type', 'exenatide BID plus glargine', 'exenatide BID plus glargine or with aspart 70/30 BID', 'premixed insulin', 'exenatide plus glargine', 'metformin', 'glp-1 agonist and basal insulin', 'premixed human insulin', 'exenatide']","['Weight', 'incidence of hypoglycaemia', 'nausea', 'diarrhea', 'vomiting', 'HbA1c control']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0795635', 'cui_str': 'Regular Insulin, Human'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0795635', 'cui_str': 'Regular Insulin, Human'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0205112', 'cui_str': 'Basal'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",200.0,0.086415,"The incidence of hypoglycaemia was similar in two groups (27% for exenatide and 38% for aspart 70/30, respectively; P = 0.1). ","[{'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yongping', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Shiyin', 'Initials': 'S', 'LastName': 'Shao', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yanran', 'Initials': 'Y', 'LastName': 'Duan', 'Affiliation': 'Department of Epidemiology and Health Statistics, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Peiwen', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'el, Wuhan, China.'}, {'ForeName': 'Liya', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Wuhan Sixth Hospital, Wuhan, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Combine Traditional Chinese and Western Medicine Hospital, Wuhan, China.'}, {'ForeName': 'Jiaoe', 'Initials': 'J', 'LastName': 'Zeng', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Jingzhou Central Hospital, Jingzhou, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Wuhan PuAi Hospital, Wuhan, China.'}, {'ForeName': 'Shi', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Wuhan Central Hospital, Wuhan, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Nanjing First Hospital, Nanjing, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhao', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Xiaogan Central Hospital, Xiaogan, China.'}, {'ForeName': 'Juping', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': ""Division of Endocrinology, Department of Internal Medicine, The Third People's Hospital of Hubei Province, Wuhan, China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Liao', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, The Armed Police General Hospital, Chongqing, China.'}, {'ForeName': 'Xiaowen', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Huangshi Central Hospital, Huangshi, China.'}, {'ForeName': 'Shufang', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Hankou Railway Hospital. Wuhan, China.'}, {'ForeName': 'Yaoming', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Nanfang Hospital, Southern Medical University. Guangzhou, China.'}, {'ForeName': 'Zhaoyang', 'Initials': 'Z', 'LastName': 'Zeng', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Yichang Central Hospital, Yichang, China.'}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Zhelong', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Computer Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Liegang', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Nutrition and Food Hygiene, Hubei Key Laboratory of Food Nutrition and Safety, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Yin', 'Affiliation': 'Department of Epidemiology and Health Statistics, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xuefeng', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: xfyu188@163.com.'}]",Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists,['10.1016/j.eprac.2021.03.015'] 3222,33831502,Effects of transcranial direct current stimulation on balance after ischemic stroke (SANDE trial): Study protocol for a multicentric randomized controlled trial.,"BACKGROUND Among the tools used for motor rehabilitation after stroke, transcranial direct current electrical stimulation (tDCS) aims to modify cortical excitability and improve motor function. Despite promising results, the effects of tDCS on balance after stroke have not yet been assessed using specific protocols. Therefore, this study will aim to evaluate the effects of tDCS and rehabilitation on balance after stroke. METHODS Eighty-two ischemic stroke patients across two inpatient rehabilitation sites in Brazil will be randomized into one of two treatment programs (anodic tDCS and sham tDCS), both associated with balance training, each 2 days/week, for six weeks and monitored for exertion, repetition and quality of movements. The primary outcome measure is the balance. Secondary outcomes will include clinical and functional measures. Outcome data will be assessed at two time points. DISCUSSION This trial will contribute to clarify if anodal tDCS is effective when associated with balance training to stroke recovery.",2021,"METHODS Eighty-two ischemic stroke patients across two inpatient rehabilitation sites in Brazil will be randomized into one of two treatment programs (anodic tDCS and sham tDCS), both associated with balance training, each 2 days/week, for six weeks and monitored for exertion, repetition and quality of movements.","['Eighty-two ischemic stroke patients across two inpatient rehabilitation sites in Brazil', 'balance after ischemic stroke (SANDE trial']","['transcranial direct current electrical stimulation (tDCS', 'transcranial direct current stimulation', 'tDCS and rehabilitation', 'tDCS', 'treatment programs (anodic tDCS and sham tDCS']","['balance', 'clinical and functional measures']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0704576,"METHODS Eighty-two ischemic stroke patients across two inpatient rehabilitation sites in Brazil will be randomized into one of two treatment programs (anodic tDCS and sham tDCS), both associated with balance training, each 2 days/week, for six weeks and monitored for exertion, repetition and quality of movements.","[{'ForeName': 'Tatiane de Jesus', 'Initials': 'TJ', 'LastName': 'Chagas', 'Affiliation': 'Physical Therapy Department, Federal University of Triângulo Mineiro (UFTM), Uberaba, Minas Gerais, Brazil.'}, {'ForeName': 'Igor Sandoval Dos Santos', 'Initials': 'ISDS', 'LastName': 'Cravo', 'Affiliation': 'Physical Therapy Department, Federal University of Triângulo Mineiro (UFTM), Uberaba, Minas Gerais, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Bazan', 'Affiliation': 'Department of Neurology, Psychology and Psychiatry, Botucatu Medical School (UNESP), Botucatu, São Paulo, Brazil.'}, {'ForeName': 'Luciane Aparecida Pascucci Sande', 'Initials': 'LAPS', 'LastName': 'de Souza', 'Affiliation': 'Physical Therapy Department, Federal University of Triângulo Mineiro (UFTM), Uberaba, Minas Gerais, Brazil.'}, {'ForeName': 'Gustavo José', 'Initials': 'GJ', 'LastName': 'Luvizutto', 'Affiliation': 'Physical Therapy Department, Federal University of Triângulo Mineiro (UFTM), Uberaba, Minas Gerais, Brazil. Electronic address: gluvizutto@gmail.com.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106396'] 3223,33831489,"Comments on ""fructose- and sucrose- but not glucose-sweetened beverages promote hepatic de novo lipogenesis - A randomized controlled trial"".",,2021,,[],[],[],[],[],[],,0.271709,,"[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Prinz', 'Affiliation': 'Department of Nutritional Sciences, German Sugar Association, Berlin, Germany. Electronic address: prinz@zuckerverbaende.de.'}]",Journal of hepatology,['10.1016/j.jhep.2021.03.022'] 3224,33831097,"Topical NAVS naphthalan for the treatment of oral lichen planus and recurrent aphthous stomatitis: A double blind, randomized, parallel group study.","AIM To evaluate the effectiveness of non-aromatic very rich in steranes (NAVS) naphthalan in the treatment of oral lichen planus (OLP) and recurrent aphthous stomatitis (RAS). Null hypothesis was that there would be no difference between NAVS and topical steroids in the treatment of OLP and RAS. METHODS The study consisted of two sub-trials conducted as randomized, double-blind controlled studies: first included OLP patients and second patients with RAS. Patients received either NAVS or 0.05% betamethasone dipropionate. Primary outcomes were activity score (OLP patients), No of lesions and lesion diameter (RAS patients) and pain intensity (VAS) while secondary outcome included the impact of the disease on quality of life assessed by Oral health impact profile (OHIP 14). RESULTS No significant differences in terms of OLP clinical signs (p = 0.84, η2 = 0.001) and responses on the OHIP-14 (p = 0.81, η2 = 0.002) or on VAS (p = 0.14, η2 = 0.079) between NAVS and betamethasone groups were observed. In RAS patients, no significant differences between the groups in terms of lesion number (at days 3 and 5, p = 0.33 and p = 0.98, respectively), lesion diameter (days 3 and 5, p = 0.24 and p = 0.84, respectively) were observed. However, in NAVS group a significant reduction of lesions diameter was observed on the 3rd day, while in betamethasone group a significant reduction in lesions diameter was evident only after the 5th day. No significant differences in VAS (p > 0.05) and the OHIP-14 (p > 0.05) between groups were found. CONCLUSION No evidence of differences between the two compared interventions was found. REGISTRATION Retrospective registration of this trial was conducted in ClinicalTrials.gov on September 30, 2016; trial registration number: NCT02920658. https://clinicaltrials.gov/ct2/show/NCT02920658?term=NAVS&draw=2&rank=4.",2021,"No significant differences in terms of OLP clinical signs (p = 0.84, η2 = 0.001) and responses on the OHIP-14 (p = 0.81, η2 = 0.002) or on VAS (p = 0.14, η2 = 0.079) between NAVS and betamethasone groups were observed.","['oral lichen planus and recurrent aphthous stomatitis', 'oral lichen planus (OLP) and recurrent aphthous stomatitis (RAS', 'patients and second patients with RAS']","['Topical NAVS naphthalan', 'NAVS', 'OLP', 'betamethasone', 'betamethasone dipropionate']","['lesions diameter', 'lesions and lesion diameter (RAS patients) and pain intensity (VAS', 'OLP clinical signs', 'activity score (OLP patients', 'VAS', 'impact of the disease on quality of life assessed by Oral health impact profile (OHIP 14', 'lesion diameter', 'OHIP-14', 'lesion number']","[{'cui': 'C0206139', 'cui_str': 'Oral lichen planus'}, {'cui': 'C2931748', 'cui_str': 'Sutton disease 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205436', 'cui_str': 'Second'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0068408', 'cui_str': 'naphthalan'}, {'cui': 'C0206139', 'cui_str': 'Oral lichen planus'}, {'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C0053523', 'cui_str': 'Betamethasone dipropionate'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C2931748', 'cui_str': 'Sutton disease 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0206139', 'cui_str': 'Oral lichen planus'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449791', 'cui_str': 'Number of lesions'}]",,0.342338,"No significant differences in terms of OLP clinical signs (p = 0.84, η2 = 0.001) and responses on the OHIP-14 (p = 0.81, η2 = 0.002) or on VAS (p = 0.14, η2 = 0.079) between NAVS and betamethasone groups were observed.","[{'ForeName': 'Ana Andabak', 'Initials': 'AA', 'LastName': 'Rogulj', 'Affiliation': 'Department of Oral Medicine, School of Dental Medicine, University of Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Iva', 'Initials': 'I', 'LastName': 'Z Alajbeg', 'Affiliation': 'Department of Dentistry, Clinical Hospital Center Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Vlaho', 'Initials': 'V', 'LastName': 'Brailo', 'Affiliation': 'Department of Oral Medicine, School of Dental Medicine, University of Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Škrinjar', 'Affiliation': 'Department of Oral Medicine, School of Dental Medicine, University of Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Ivona', 'Initials': 'I', 'LastName': 'Žužul', 'Affiliation': 'Department of Oral Surgery, School of Dental Medicine, University of Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Vanja', 'Initials': 'V', 'LastName': 'Vučićević-Boras', 'Affiliation': 'Department of Oral Medicine, School of Dental Medicine, University of Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Alajbeg', 'Affiliation': 'Department of Oral Medicine, School of Dental Medicine, University of Zagreb, Zagreb, Croatia.'}]",PloS one,['10.1371/journal.pone.0249862'] 3225,33831037,"Fatigue, induced via repetitive upper-limb motor tasks, influences trunk and shoulder kinematics during an upper limb reaching task in a virtual reality environment.","BACKGROUND Efficient shoulder movement depends on the ability of central nervous system to integrate sensory information and to create an appropriate motor command. Various daily encountered factors can potentially compromise the execution of the command, such as fatigue. This study explored how fatigue influences shoulder movements during upper limb reaching. METHODS Forty healthy participants were randomly assigned to one of two groups: Control or Fatigue Group. All participants completed an upper limb reaching task at baseline and post-experimental, during which they reached four targets located at 90° of shoulder abduction, 90° external rotation at 90° abduction, 120° scaption, and 120° flexion in a virtual reality environment. Following the baseline phase, the Fatigue Group completed a shoulder fatigue protocol, while Controls took a 10-minute break. Thereafter, the reaching task was repeated. Upper limb kinematic (joint angles and excursions) and spatiotemporal (speed and accuracy) data were collected during the reaching task. Electromyographic activity of the anterior and middle deltoids were also collected to characterize fatigue. Two-way repeated-measures ANOVA were performed to determine the effects of Time, Group and of the interaction between these factors. RESULTS The Fatigue group showed decreased mean median power frequency and increased electromyographic amplitudes of the anterior deltoid (p < 0.05) following the fatigue protocol. Less glenohumeral elevation, increased trunk flexion and rotation and sternoclavicular elevation were also observed in the Fatigue group (Group x Time interaction, p < 0.05). The Control group improved their movement speed and accuracy in post-experimental phase, while the Fatigue group showed a decrease of movement speed and no accuracy improvement (Group x Time interaction, p < 0.05). CONCLUSION In a fatigued state, changes in movement strategy were observed during the reaching task, including increased trunk and sternoclavicular movements and less glenohumeral movement. Performance was altered as shown by the lack of accuracy improvement over time and a decrease in movement speed in the Fatigue group.",2021,Performance was altered as shown by the lack of accuracy improvement over time and a decrease in movement speed in the Fatigue group.,['Forty healthy participants'],['Control or Fatigue Group'],"['Electromyographic activity of the anterior and middle deltoids', 'Upper limb kinematic (joint angles and excursions) and spatiotemporal (speed and accuracy) data', 'mean median power frequency and increased electromyographic amplitudes of the anterior deltoid', 'movement speed and accuracy', 'increased trunk and sternoclavicular movements and less glenohumeral movement', 'movement speed', 'trunk flexion and rotation and sternoclavicular elevation', 'Fatigue, induced via repetitive upper-limb motor tasks, influences trunk and shoulder kinematics', 'movement speed and no accuracy improvement']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0224234', 'cui_str': 'Structure of deltoid muscle'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}]",40.0,0.0623968,Performance was altered as shown by the lack of accuracy improvement over time and a decrease in movement speed in the Fatigue group.,"[{'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Dupuis', 'Affiliation': 'Faculty of Medicine, Université Laval, Quebec City, Canada.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Sole', 'Affiliation': 'Centre for Health, Activity and Rehabilitation Research, School of Physiotherapy, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Wassinger', 'Affiliation': 'Department of Physical Therapy, East Tennessee State University, Johnson City, TN, United States of America.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Bielmann', 'Affiliation': 'Centre for Interdisciplinary Research in Rehabilitation and Social Integration, Quebec City, Canada.'}, {'ForeName': 'Laurent J', 'Initials': 'LJ', 'LastName': 'Bouyer', 'Affiliation': 'Faculty of Medicine, Université Laval, Quebec City, Canada.'}, {'ForeName': 'Jean-Sébastien', 'Initials': 'JS', 'LastName': 'Roy', 'Affiliation': 'Faculty of Medicine, Université Laval, Quebec City, Canada.'}]",PloS one,['10.1371/journal.pone.0249403'] 3226,33831022,The impact of Tai Chi and mind-body breathing in COPD: Insights from a qualitative sub-study of a randomized controlled trial.,"PURPOSE Chronic obstructive pulmonary disease (COPD) is associated with multiple psychosocial and behavioral factors. Prior research suggests that mind-body interventions may support the development and maintenance of healthy behaviors and improve health-related quality-of-life in such patients. We sought to qualitatively explore cognitive, psychosocial, and behavioral changes in patients with COPD who participated in two different mind-body interventions compared to an education control. METHODS We analyzed semi-structured qualitative exit interviews from a prospective, randomized pilot trial (N = 123) investigating 12-weeks of Tai Chi (TC) vs. mind-body breathing (MBB) vs. education (EDU) control in patients with moderate-severe COPD. TC involved traditional movements, that integrate meditative breathing, while MBB focused mainly on meditative breathing techniques alone. Interviews were audio-recorded and transcribed verbatim. Qualitative analysis of randomly selected transcripts was performed by two independent reviewers using an iterative process to identify emergent themes informed by grounded theory methods until thematic saturation was reached. RESULTS A total of 66 transcripts were reviewed (N = 22 TC, N = 22 MBB, N = 22 EDU). Participants were mean age = 68.1 years, GOLD Stage = 2.3, baseline FEV11 percent predicted mean (SD): 58% (13.4), 42.4% female. We identified six frequently mentioned themes: 1) overall awareness and understanding, 2) self-care knowledge, skills and behaviors, 3) behavior-related neurocognitive concepts, 4) physical function, 5) psychological well-being, and 6) social support/social function. Compared to EDU, more participants in TC and MBB noted improvements in awareness of self and the mind-body connection (e.g., body and breath awareness), knowledge of breathing techniques and integration of self-care skills with daily activities, self-efficacy for symptom management (particularly managing anxiety and dyspnea), acceptance of disease, physical function improvements (e.g., endurance, dyspnea, fatigue), and psychological well-being (particularly relaxation, emotion regulation and decreased reactivity). Compared to MBB, those in TC shared more intention to continue with self-care behaviors, physical activity self-efficacy, and improved flexibility. All three groups, including EDU, noted increased social support and knowledge of disease. Those in EDU, however, had fewer mentions of processes related to behavior change, and less concrete changes in neurocognitive, psychological, and physical function domains. CONCLUSIONS Mind-body interventions including meditative breathing may impact behavior-related neurocognitive and emotional factors that improve self-care management and support positive behavioral changes in patients with COPD. TRIAL REGISTRATION This trial is registered in Clinical Trials.gov, ID number NCT01551953.",2021,"Compared to EDU, more participants in TC and MBB noted improvements in awareness of self and the mind-body connection (e.g., body and breath awareness), knowledge of breathing techniques and integration of self-care skills with daily activities, self-efficacy for symptom management (particularly managing anxiety and dyspnea), acceptance of disease, physical function improvements (e.g., endurance, dyspnea, fatigue), and psychological well-being (particularly relaxation, emotion regulation and decreased reactivity).","['patients with moderate-severe COPD', 'COPD', 'patients with COPD', 'Chronic obstructive pulmonary disease (COPD', 'patients with COPD who participated in two different mind-body interventions compared to an education control', 'Participants were mean age = 68.1 years, GOLD Stage = 2.3, baseline FEV11 percent predicted mean (SD): 58% (13.4), 42.4% female']","['Tai Chi and mind-body breathing', 'Tai Chi (TC) vs. mind-body breathing (MBB) vs. education (EDU) control']","['awareness of self and the mind-body connection (e.g., body and breath awareness), knowledge of breathing techniques and integration of self-care skills with daily activities, self-efficacy for symptom management (particularly managing anxiety and dyspnea), acceptance of disease, physical function improvements (e.g., endurance, dyspnea, fatigue), and psychological well-being (particularly relaxation, emotion regulation and decreased reactivity', 'neurocognitive, psychological, and physical function domains', 'overall awareness and understanding, 2) self-care knowledge, skills and behaviors, 3) behavior-related neurocognitive concepts, 4) physical function, 5) psychological well-being, and 6) social support/social function', 'physical activity self-efficacy, and improved flexibility', 'social support and knowledge of disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0730607', 'cui_str': 'Severe chronic obstructive pulmonary disease'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C1513305', 'cui_str': 'Mind-Body Medicine'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C4517558', 'cui_str': '13.4'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3146223', 'cui_str': 'Awareness of self'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",123.0,0.0169604,"Compared to EDU, more participants in TC and MBB noted improvements in awareness of self and the mind-body connection (e.g., body and breath awareness), knowledge of breathing techniques and integration of self-care skills with daily activities, self-efficacy for symptom management (particularly managing anxiety and dyspnea), acceptance of disease, physical function improvements (e.g., endurance, dyspnea, fatigue), and psychological well-being (particularly relaxation, emotion regulation and decreased reactivity).","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Gilliam', 'Affiliation': 'Division of General Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Brookline, MA, United States of America.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Cheung', 'Affiliation': 'Division of General Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Brookline, MA, United States of America.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Kraemer', 'Affiliation': 'Division of General Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Brookline, MA, United States of America.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Litrownik', 'Affiliation': 'Division of General Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Brookline, MA, United States of America.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Wayne', 'Affiliation': 'Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Marilyn L', 'Initials': 'ML', 'LastName': 'Moy', 'Affiliation': 'Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Gloria Y', 'Initials': 'GY', 'LastName': 'Yeh', 'Affiliation': 'Division of General Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Brookline, MA, United States of America.'}]",PloS one,['10.1371/journal.pone.0249263'] 3227,33830998,"Metformin and N-terminal pro B-type natriuretic peptide in type 2 diabetes patients, a post-hoc analysis of a randomized controlled trial.","BACKGROUND Beyond antihyperglycemic effects, metformin may improve cardiovascular outcomes. Patients with type 2 diabetes often have an elevated plasma level of N-terminal pro B-type as a marker of (sub) clinical cardiovascular disease. We studied whether metformin was associated with a reduction in the serum level of N-terminal pro B-type natriuretic peptide (NT-proBNP) in these patients. METHODS In the HOME trial 390 insulin-treated patients with type 2 diabetes were randomized to 850 mg metformin or placebo three times daily. Plasma samples were drawn at baseline, 4, 17, 30, 43 and 52 months. In a post-hoc analysis we analyzed the change in NT-proBNP in both groups. We used a longitudinal mixed model analysis adjusting for age, sex and prior cardiovascular disease. In a secondary analysis we assessed a possible immediate treatment effect post baseline. RESULTS Metformin did not affect NT-proBNP levels over time in the primary analysis (-1% [95%CI -4;3, p = 0.62]). In the secondary analysis there was also no sustained time independent immediate treatment effect (initial increase of 17% [95%CI 4;30, p = 0.006] followed by yearly decrease of -4% [95%CI -7;0, p = 0.07]). CONCLUSIONS Metformin as compared to placebo did not affect NT-proBNP plasma levels in this 4.3-year placebo-controlled trial. Potential cardioprotective effects of metformin cannot be explained by changes in cardiac pressures or volumes to the extent reflected by NT-proBNP.",2021,"Metformin did not affect NT-proBNP levels over time in the primary analysis (-1% [95%CI -4;3, p = 0.62]).","['type 2 diabetes patients', '390 insulin-treated patients with type 2 diabetes', 'Patients with type 2 diabetes often have an elevated plasma level of N-terminal pro B-type as a marker of (sub) clinical cardiovascular disease']","['metformin or placebo', 'Metformin and N-terminal pro B-type natriuretic peptide', 'metformin', 'placebo', 'Metformin']","['serum level of N-terminal pro B-type natriuretic peptide (NT-proBNP', 'NT-proBNP levels', 'change in NT-proBNP', 'NT-proBNP plasma levels', 'cardiovascular outcomes']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1292769', 'cui_str': 'Precursor B-cell lymphoblastic leukemia'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.342693,"Metformin did not affect NT-proBNP levels over time in the primary analysis (-1% [95%CI -4;3, p = 0.62]).","[{'ForeName': 'Wiebe M C', 'Initials': 'WMC', 'LastName': 'Top', 'Affiliation': 'Department of Internal Medicine, Care Group Treant, Location Bethesda Hoogeveen, Hoogeveen, The Netherlands.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Lehert', 'Affiliation': 'Department of Statistics, Faculty of Economics, Facultés Universitaires Catholiques de Mons, Louvain Academy, Mons, Belgium.'}, {'ForeName': 'Casper G', 'Initials': 'CG', 'LastName': 'Schalkwijk', 'Affiliation': 'Department of Internal Medicine and Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Coen D A', 'Initials': 'CDA', 'LastName': 'Stehouwer', 'Affiliation': 'Department of Internal Medicine and Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Adriaan', 'Initials': 'A', 'LastName': 'Kooy', 'Affiliation': 'Department of Internal Medicine, Care Group Treant, Location Bethesda Hoogeveen, Hoogeveen, The Netherlands.'}]",PloS one,['10.1371/journal.pone.0247939'] 3228,33833952,Does the Presence of Impacted Mandibular Third Molars Increase the Risk of Bad Split Incidence During Bilateral Sagittal Split Osteotomy?,"BACKGROUND The possibility of mandibular bad spilt might happen during bilateral sagittal split osteotomy (BSSO). This study investigated the effect of impacted mandibular third molars on bad spilt incidence during BSSO. METHODS Totally, 140 patients under 40 years old who were candidates for BSSO surgery due to class 3 skeletal discrepancy were divided randomly into two equal groups. The impacted mandibular third molars were presented in one group during BSSO (Exposed), and the third molars were removed at least six months before surgery for the other group (Unexposed). All cases underwent BSSO using the same technique by a single surgeon. A bad split was diagnosed by inter-operative clinical examination and postoperative panoramic radiography. RESULTS Four bad split occurrences were observed including three patients in the group which impacted mandibular third molars were presented and one patient in the group without impacted mandibular third molars. The incidence of bad fracture in the exposed group was 3.7 times more than the unexposed group. The incidence of the bad fracture in exposed group was 3.7 times more than unexposed group. The chance of fractures in females was 1.7 times higher than males. With one year addition to the patient's age, chance of fracture increased 0.985 times more. CONCLUSION Overall incidence of bad split fracture in presence of mandibular third molars in females and at older ages increased during BSSO. The extraction of impacted mandibular third molars, six months before the BSSO is recommended to prevent the bad split incidence during the operation.",2021,Overall incidence of bad split fracture in presence of mandibular third molars in females and at older ages increased during BSSO.,"['mandibular third molars in females and at older ages increased during BSSO', '140 patients under 40 years old who were candidates for BSSO surgery due to class 3 skeletal discrepancy']",['bilateral sagittal split osteotomy (BSSO'],"['chance of fractures', 'incidence of the bad fracture', 'incidence of bad fracture', 'Overall incidence of bad split fracture', 'Risk of Bad Split Incidence']","[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}]","[{'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",140.0,0.0220937,Overall incidence of bad split fracture in presence of mandibular third molars in females and at older ages increased during BSSO.,"[{'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Eshghpour', 'Affiliation': 'Oral and Maxillofacial Diseases Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Labafchi', 'Affiliation': 'Student Research Committee, Faculty of Dentistry, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Sahand', 'Initials': 'S', 'LastName': 'Samieirad', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, Mashhad Dental School, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Hosseini Abrishami', 'Affiliation': 'Oral and Maxillofacial Diseases Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Nodehi', 'Affiliation': 'Student Research Committee, Faculty of Dentistry, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Abdollah', 'Initials': 'A', 'LastName': 'Rashid Javan', 'Affiliation': 'Department of Biostatistics, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",World journal of plastic surgery,['10.29252/wjps.10.1.37'] 3229,33833949,Supraclavicular Artery Flap versus Skin Graft: Which Is a Better Reconstructive Tool for Managing Post-Burn Contractures in the Neck.,"BACKGROUND Burn in developing countries still has high burden of inadequately managed severe burns. This study compared supraclavicular artery flap and skin graft in managing neck post-burn contractures. METHODS In National Institute of Rehabilitation Medicine and Pakistan Institute of Medical Sciences, Islamabad, Pakistan, 30 patients with neck post-burn contractures were enrolled. Half of patients randomly underwent supraclavicular artery flap and half received skin graft. The outcome measures including initial improvement in neck extension, patient's satisfaction with color-texture-match and recurrent contracture formation rate were assessed. RESULTS Among patients, 80% were female and 20% were male. Preoperatively, each group had post-burn contractures of grade II among 26.66% of patients, grade III among 60% and grade III among 13.3%. Postoperatively after three months in the two groups, 86.66% improved to grade I and 13.3% improved to grade II. Patient's satisfaction with color-texture was 84.66% in supraclavicular artery flap group, whereas it was 42.66% for skin graft group. Complications were hypertrophic scar at donor site (13%) and flap tip necrosis (6.66%) in supraclavicular artery flap group. In skin graft group, partial skin graft loss was noticed among 33% of patients and delayed healing of donor site among 20%. The recurrent contracture formation rate at one year was 73.33% in skin graft group, whereas there was no case of recurrent contracture in supraclavicular artery flap group. CONCLUSION Supraclavicular artery flap was superior to skin graft in managing post-burn neck contractures. It provided better color-texture match and was associated with no recurrence of contracture formation.",2021,"Preoperatively, each group had post-burn contractures of grade II among 26.66% of patients, grade III among 60% and grade III among 13.3%.","['30 patients with neck post-burn contractures were enrolled', 'Among patients, 80% were female and 20% were male']","['supraclavicular artery flap and half received skin graft', 'supraclavicular artery flap and skin graft', 'Supraclavicular artery flap', 'Supraclavicular Artery Flap versus Skin Graft']","['recurrent contracture', 'recurrent contracture formation rate', 'partial skin graft loss', 'flap tip necrosis', ""initial improvement in neck extension, patient's satisfaction with color-texture-match and recurrent contracture formation rate"", ""Patient's satisfaction with color-texture"", 'recurrence of contracture formation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0009917', 'cui_str': 'Contracture'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0589496', 'cui_str': 'Supraclavicular approach'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0037297', 'cui_str': 'Grafting to skin'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0009917', 'cui_str': 'Contracture'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0438397', 'cui_str': 'Skin graft failure'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0522507', 'cui_str': 'With color'}, {'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",30.0,0.0188047,"Preoperatively, each group had post-burn contractures of grade II among 26.66% of patients, grade III among 60% and grade III among 13.3%.","[{'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Saaiq', 'Affiliation': 'Department of Plastic Surgery and Burns, National Institute of Rehabilitation Medicine (NIRM), Islamabad, Pakistan.'}]",World journal of plastic surgery,['10.29252/wjps.10.1.15'] 3230,33833948,"The Effect of Bimaxillary Orthognathic Surgery on Nasalance, Articulation Errors, and Speech Intelligibility in Skeletal Class III Deformity Patients.","BACKGROUND We aimed to detect the changes in nasalance, articulation errors, and speech intelligibility after bimaxillary orthognathic surgery in skeletal class III patients. METHODS This double-blinded before and after quasi-experimental study was conducted in the Department of Maxillofacial Surgery, Qaem Hospital, Mashhad, Iran from Mar 2019 to Apr 2020. The main intervention was maxillary advancement with LeFort I osteotomy and mandibular setback surgery with bilateral sagittal split osteotomy (BSSO). The nasalance score, speech intelligibility, and articulation errors were evaluated one week preoperatively (T 0 ), 1 and 6 months (T 1 , T 2 ) postoperatively by a speech therapist. The significance level was set at 0.05 using SPSS 21. RESULTS Eleven women (55%) and 9 men (45%) with a mean age of 31.95 ± 4.72 yr were enrolled. The mean maxillomandibular discrepancy was 6.15 ± 1.53 mm. The mean scores of nasalance for the oral, nasal, and oral-nasal sentences were significantly improved postoperatively ( P <0.001). Pre-operative articulation errors of consonants /r/, /z/, /s/ and /sh/ were corrected following the surgery. The percentage of speech intelligibility was significantly increased over time ( P <0.001). CONCLUSION The patients might show a normal articulation pattern and a modified nasalance feature, following maxillary advancement plus mandibular setback surgery.",2021,"The mean scores of nasalance for the oral, nasal, and oral-nasal sentences were significantly improved postoperatively ( P <0.001).","['Skeletal Class III Deformity Patients', 'skeletal class III patients', 'Eleven women (55%) and 9 men (45%) with a mean age of 31.95 ± 4.72 yr were enrolled', 'Department of Maxillofacial Surgery, Qaem Hospital, Mashhad, Iran from Mar 2019 to Apr 2020']","['LeFort I osteotomy and mandibular setback surgery with bilateral sagittal split osteotomy (BSSO', 'Bimaxillary Orthognathic Surgery', 'maxillary advancement plus mandibular setback surgery']","['Nasalance, Articulation Errors, and Speech Intelligibility', 'percentage of speech intelligibility', 'nasalance, articulation errors, and speech intelligibility', 'mean scores of nasalance for the oral, nasal, and oral-nasal sentences', 'nasalance score, speech intelligibility, and articulation errors']","[{'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0038908', 'cui_str': 'Oral surgery'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0024782', 'cui_str': 'Marathi language'}, {'cui': 'C2004459', 'cui_str': 'Abdominoperineal resection'}]","[{'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0185624', 'cui_str': 'Orthognathic Surgery'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0441478', 'cui_str': 'Surgical advancement - action'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}]",11.0,0.161357,"The mean scores of nasalance for the oral, nasal, and oral-nasal sentences were significantly improved postoperatively ( P <0.001).","[{'ForeName': 'Hamide', 'Initials': 'H', 'LastName': 'Ghaemi', 'Affiliation': 'Department of Speech Therapy, School of Paramedical Sciences, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Erfan', 'Initials': 'E', 'LastName': 'Emrani', 'Affiliation': 'Student Research Committee, Faculty of Dentistry, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Labafchi', 'Affiliation': 'Student Research Committee, Faculty of Dentistry, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Khashyar', 'Initials': 'K', 'LastName': 'Famili', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Mashhad Dental School, Mashhad University of Medical Science, Mashhad, Iran.'}, {'ForeName': 'Haleh', 'Initials': 'H', 'LastName': 'Hashemzadeh', 'Affiliation': 'Department of Orthodontics, Tehran Dental School, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Sahand', 'Initials': 'S', 'LastName': 'Samieirad', 'Affiliation': 'Oral and maxillofacial diseases research center, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",World journal of plastic surgery,['10.29252/wjps.10.1.8'] 3231,33833945,Telemedicine Intervention to Improve Long-Term Risk Factor Control and Body Composition in Persons with High Cardiovascular Risk: Results from a Randomized Trial: Telehealth strategies may offer an advantage over standard institutional based interventions for improvement of cardiovascular risk in high-risk patients long-term.,"Background Telehealth strategies are increasingly used to support people at high cardiovascular risk long-term, but is it unclear if these interventions are effective at improving cardiovascular risk. Objective To evaluate the effects of a telemedicine technology-based program on risk factor control and body composition in patients at high cardiovascular risk. Methods This is a population based randomized controlled trial. 100 patients at high and very high cardiovascular risk were randomly assigned to a telemedicine technology-based program consisting of: Comprehensive counseling on risk factors delivered by a physician; biweekly remote support via phone delivered by a trained nurse during the first three months after enrollment; and a control group receiving routine care with individual single-session counseling on patients' current risk factors without further support. The follow-up period was 1 year. Results Mean age of participants was 59.9 ± 4.5 years, 80% were women. Weight (-0.582; p < 0.001), waist circumference (-0.429; p = 0.01), body mass index (-0.216; p < 0.001) diastolic blood pressure (-0.881; p = 0.04), total cholesterol (-0.149; p = 0.01) and LDL cholesterol (-0.123; p = 0.003) were lower in the intervention group compared to the control group after 12-month. Body fat mass was also lower (-0.352; p = 0.01) and lean mass was higher (0.92; p = 0.03) in the intervention group. Anxiety scores (-2.5; p < 0.002) and depression scores (-2.6; p < 0.001) were also lower in the intervention group. Conclusions Among older people at high cardiovascular risk, the addition of telehealth strategies using remote support by phone calls over a period of 3 month resulted in small but significant improvements of cardiovascular risk factors, body composition, anxiety, and depression which are maintained long-term. Such telehealth strategies may offer an advantage over standard institution-based interventions.",2021,Body fat mass was also lower (-0.352; p = 0.01) and lean mass was higher (0.92; p = 0.03) in the intervention group.,"['100 patients at high and very high cardiovascular risk', 'patients at high cardiovascular risk', 'older people at high cardiovascular risk', 'Mean age of participants was 59.9 ± 4.5 years, 80% were women', 'Persons with High Cardiovascular Risk']","['telemedicine technology-based program', 'telemedicine technology-based program consisting of: Comprehensive counseling on risk factors delivered by a physician; biweekly remote support via phone delivered by a trained nurse during the first three months after enrollment; and a control group receiving routine care with individual single-session counseling', 'Telemedicine Intervention']","['risk factor control and body composition', 'diastolic blood pressure ', 'total cholesterol ', 'Anxiety scores', 'lean mass', 'depression scores', 'cardiovascular risk', 'cardiovascular risk factors, body composition, anxiety, and depression', 'LDL cholesterol', 'body mass index ', 'waist circumference ', 'Body fat mass', 'Weight ']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0442804', 'cui_str': 'Very high'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",100.0,0.0114472,Body fat mass was also lower (-0.352; p = 0.01) and lean mass was higher (0.92; p = 0.03) in the intervention group.,"[{'ForeName': 'Nana', 'Initials': 'N', 'LastName': 'Pogosova', 'Affiliation': 'Federal State Institution ""National Medical Research Center of Cardiology"" of the Ministry of Healthcare of the Russian Federation, Moscow, RU.'}, {'ForeName': 'Yulia', 'Initials': 'Y', 'LastName': 'Yufereva', 'Affiliation': 'Federal State Institution ""National Medical Research Center of Cardiology"" of the Ministry of Healthcare of the Russian Federation, Moscow, RU.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Sokolova', 'Affiliation': 'Federal State Institution ""National Medical Research Center of Cardiology"" of the Ministry of Healthcare of the Russian Federation, Moscow, RU.'}, {'ForeName': 'Anara', 'Initials': 'A', 'LastName': 'Yusubova', 'Affiliation': ""Children's Diagnostics and Treatment Center after N.A. Semashko, Moscow, RU.""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Suvorov', 'Affiliation': 'City Hospital #4, Moscow, RU.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Saner', 'Affiliation': 'Institute for Social and Preventive Medicine, University of Bern, Bern, CH.'}]",Global heart,['10.5334/gh.825'] 3232,33838579,Predictors and moderators of quality of life in patients with major depressive disorder: An AGTs-MDD study report.,"Effective and targeted interventions for improving quality of life (QOL) in addition to achieving 'clinical remission' are imperatives for patients with major depressive disorder (MDD). This study aimed to examine potential predictors and moderators of QOL in depression. Data were obtained from the Algorithm Guided Treatment Strategies for Major Depressive Disorder (AGTs-MDD) study, a multisite, randomized controlled trial composed of 980 depressed patients. Mixed Model Repeated Measures (MMRM) analyses were conducted to identify baseline characteristics associated with QOL overall (predictors) and their interaction effects (moderators). Severe core depressive, anxiety and pain symptoms were found to be independently associated with poor QOL over the 12-week acute phase treatment. Severe depression, severe anxiety or pain symptoms, or severe suicidal ideation predicted a larger improvement of QOL during acute phase treatment, whereas males showed less improvement. None of the putative moderators were identified except for the educational level. Patients with lower educational level showed a larger improvement of QOL in the AGT started with escitalopram (AGT-E) group and AGT started with mirtazapine (AGT-M) group compared to the treatment as usual (TAU) group. These findings may help to instruct informed decision-making for heterogeneous patients with MDD in the view of full recovery.",2021,"Severe core depressive, anxiety and pain symptoms were found to be independently associated with poor QOL over the 12-week acute phase treatment.","['patients with major depressive disorder (MDD', 'patients with major depressive disorder', '980 depressed patients']",['mirtazapine (AGT-M'],"['quality of life (QOL', 'Severe core depressive, anxiety and pain symptoms', 'quality of life', 'QOL', 'Severe depression, severe anxiety or pain symptoms, or severe suicidal ideation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}]","[{'cui': 'C0049506', 'cui_str': 'Mirtazapine'}, {'cui': 'C0002555', 'cui_str': 'Aminoglutethimide'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0588008', 'cui_str': 'Severe depression'}, {'cui': 'C0231403', 'cui_str': 'Severe anxiety (panic)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}]",980.0,0.0425881,"Severe core depressive, anxiety and pain symptoms were found to be independently associated with poor QOL over the 12-week acute phase treatment.","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Clinical Research Center & Division of Mood Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, 200030, China.'}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry and Psychology, Shanghai Deji Hospital Affiliated to Qingdao University, Shanghai, 200331, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'Clinical Research Center & Division of Mood Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, 200030, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Clinical Research Center & Division of Mood Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, 200030, China.'}, {'ForeName': 'Yousong', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': 'Clinical Research Center & Division of Mood Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, 200030, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Clinical Research Center & Division of Mood Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, 200030, China.'}, {'ForeName': 'Maosheng', 'Initials': 'M', 'LastName': 'Fang', 'Affiliation': 'Wuhan Mental Health Center, Wuhan, 430019, China.'}, {'ForeName': 'Zhijian', 'Initials': 'Z', 'LastName': 'Yao', 'Affiliation': 'Department of Psychiatry, The Affiliated Brain Hospital of Nanjing Medical University, Nanjing, 210029, China.'}, {'ForeName': 'Zuowei', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Division of Mood Disorders, Hongkou District Mental Health Center of Shanghai, Shanghai, 200083, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Clinical Research Center & Division of Mood Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, 200030, China.'}, {'ForeName': 'Yuncheng', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Clinical Research Center & Division of Mood Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, 200030, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Clinical Research Center & Division of Mood Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, 200030, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Clinical Research Center & Division of Mood Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, 200030, China; Guangdong-Hong Kong-Macao Greater Bay Area Center for Brain Science and Brain-Inspired Intelligence, Guangzhou, 510515, China. Electronic address: doctorcj2010@gmail.com.'}, {'ForeName': 'Daihui', 'Initials': 'D', 'LastName': 'Peng', 'Affiliation': 'Clinical Research Center & Division of Mood Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, 200030, China. Electronic address: pdhsh@126.com.'}, {'ForeName': 'Yiru', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': 'Clinical Research Center & Division of Mood Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, 200030, China; CAS Center for Excellence in Brain Science and Intelligence Technology, Shanghai, 200031, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, 201108, China; Guangdong-Hong Kong-Macao Greater Bay Area Center for Brain Science and Brain-Inspired Intelligence, Guangzhou, 510515, China. Electronic address: yirufang@aliyun.com.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2021.03.063'] 3233,33838565,Prospective association between baseline plasma zinc concentration and development of proteinuria in Chinese hypertensive patients.,"OBJECTIVE We aimed to evaluate the association between baseline plasma zinc and the development of proteinuria as well as possible effect modifiers in hypertensive patients. METHODS This is a subset of the China Stroke Primary Prevention Trial (CSPPT) Renal Sub-Study. In the CSPPT, participants were randomized to receive a daily oral dose of 1 tablet containing 10 mg enalapril and 0.8 mg folic acid or 1 tablet containing 10 mg enalapril only. A total of 783 participants with plasma zinc measurements and without proteinuria at baseline were included in the current study. The study outcome was the development of proteinuria during the follow-up, defined as a urine dipstick reading of trace or ≥1+ at the exit visit. RESULTS During a median follow-up duration of 4.4 years, the development of proteinuria occurred in 93 (11.9 %) participants. There was an inverse relation of baseline plasma zinc with the development of proteinuria (per SD increment; OR, 0.74, 95 % CI: 0.55-0.99), p for trend of quartiles = 0.005. CONCLUSIONS In Chinese hypertensive patients, there was a significant inverse association between baseline plasma zinc and the development of proteinuria, although plasma zinc remained in the reference range.",2021,"There was an inverse relation of baseline plasma zinc with the development of proteinuria (per SD increment; OR, 0.74, 95 % CI: 0.55-0.99), p for trend of quartiles = 0.005. ","['783 participants with plasma zinc measurements and without proteinuria at baseline were included in the current study', 'hypertensive patients', 'Chinese hypertensive patients']","['enalapril', 'enalapril and 0.8 mg folic acid']","['development of proteinuria', 'baseline plasma zinc and the development of proteinuria, although plasma zinc', 'development of proteinuria during the follow-up, defined as a urine dipstick reading of trace or ≥1+ at the exit visit']","[{'cui': 'C0729827', 'cui_str': 'Plasma zinc measurement'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}]","[{'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0441090', 'cui_str': 'Dipstick'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0442822', 'cui_str': 'Trace'}, {'cui': 'C0337094', 'cui_str': 'Exit'}]",783.0,0.263757,"There was an inverse relation of baseline plasma zinc with the development of proteinuria (per SD increment; OR, 0.74, 95 % CI: 0.55-0.99), p for trend of quartiles = 0.005. ","[{'ForeName': 'Panpan', 'Initials': 'P', 'LastName': 'He', 'Affiliation': 'Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research, Guangdong Provincial Institute of Nephrology, Guangdong Provincial Key Laboratory of Renal Failure Research, Guangdong Provincial Clinical Research Center for Kidney Disease, Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou, 510515, China.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research, Guangdong Provincial Institute of Nephrology, Guangdong Provincial Key Laboratory of Renal Failure Research, Guangdong Provincial Clinical Research Center for Kidney Disease, Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou, 510515, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research, Guangdong Provincial Institute of Nephrology, Guangdong Provincial Key Laboratory of Renal Failure Research, Guangdong Provincial Clinical Research Center for Kidney Disease, Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou, 510515, China.'}, {'ForeName': 'Tengfei', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': 'Beijing Advanced Innovation Center for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, 100083, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Beijing Advanced Innovation Center for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, 100083, China; Institute of Biomedicine, Anhui Medical University, Hefei, 230032, China.'}, {'ForeName': 'Chengzhang', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Institute of Biomedicine, Anhui Medical University, Hefei, 230032, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Liang', 'Affiliation': 'Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research, Guangdong Provincial Institute of Nephrology, Guangdong Provincial Key Laboratory of Renal Failure Research, Guangdong Provincial Clinical Research Center for Kidney Disease, Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou, 510515, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Nie', 'Affiliation': 'Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research, Guangdong Provincial Institute of Nephrology, Guangdong Provincial Key Laboratory of Renal Failure Research, Guangdong Provincial Clinical Research Center for Kidney Disease, Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou, 510515, China.'}, {'ForeName': 'Binyan', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Institute of Biomedicine, Anhui Medical University, Hefei, 230032, China; Shenzhen Evergreen Medical Institute, Shenzhen, 518057, China.'}, {'ForeName': 'Huiyuan', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': 'Beijing Advanced Innovation Center for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, 100083, China.'}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Population, Family and Reproductive Health, Johns Hopkins University Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, MD, 21205-2179, USA.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huo', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Beijing Advanced Innovation Center for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, 100083, China.'}, {'ForeName': 'Xiping', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research, Guangdong Provincial Institute of Nephrology, Guangdong Provincial Key Laboratory of Renal Failure Research, Guangdong Provincial Clinical Research Center for Kidney Disease, Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou, 510515, China; Beijing Advanced Innovation Center for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, 100083, China. Electronic address: xipingxu126@126.com.'}, {'ForeName': 'Xianhui', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research, Guangdong Provincial Institute of Nephrology, Guangdong Provincial Key Laboratory of Renal Failure Research, Guangdong Provincial Clinical Research Center for Kidney Disease, Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou, 510515, China. Electronic address: pharmaqin@126.com.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2021.126755'] 3234,33838536,"Ultrasound-guided erector spinae plane block for postoperative analgesia in patients undergoing open radical prostatectomy: A randomized, placebo-controlled trial.","STUDY OBJECTIVE The aim of this study was to evaluate the effect of ultrasound-guided erector spinae plane (ESP) block on postoperative pain in radical prostatectomy, which leads to both visceral and somatic pain. DESIGN Prospective, randomized, placebo controlled, double-blinded. SETTING University hospital. PATIENTS A total of ASA I-III, 50 patients aged 18-65 who were scheduled for elective open radical prostatectomy surgery. INTERVENTIONS Patients were randomly allocated to receive an ultrasound-guided ESP block, with either local anesthetic (10 mL of 1% lidocaine +10 mL of 0.5% bupivacaine) or placebo bilaterally. MEASUREMENTS The primary outcome was morphine consumption in the first 24 h after surgery. The secondary outcomes were NRS pain scores at rest and coughing, intraoperative remifentanil consumption and need for rescue analgesic during the first 24 h after surgery. MAIN RESULTS Both NRS scores for post-anesthesia care unit and NRS rest scores for 1st hours were lower in Group ESPB (p < 0.001 and p = 0.033, respectively). Cumulative morphine consumption at 24 h post-surgery was similar between the groups (p = 0.447). Rescue analgesic requirement was higher in the placebo injection group than in the ESPB group at the 1st postoperative hour (p = 0.002). CONCLUSIONS In open radical prostatectomies, except for the first hour, ESP block is ineffective for pain scores and on morphine consumption compared to the placebo injection group in the postoperative period.",2021,"Both NRS scores for post-anesthesia care unit and NRS rest scores for 1st hours were lower in Group ESPB (p < 0.001 and p = 0.033, respectively).","['50 patients aged 18-65 who were scheduled for elective open radical prostatectomy surgery', 'University hospital', 'patients undergoing open radical prostatectomy']","['ultrasound-guided erector spinae plane (ESP) block', 'ultrasound-guided ESP block, with either local anesthetic (10\xa0mL of 1% lidocaine +10\xa0mL of 0.5% bupivacaine', 'ESPB', 'placebo bilaterally', 'Ultrasound-guided erector spinae plane block', 'placebo']","['Rescue analgesic requirement', 'pain scores', 'morphine consumption', 'Cumulative morphine consumption', 'NRS pain scores at rest and coughing, intraoperative remifentanil consumption and need for rescue analgesic during the first 24\xa0h after surgery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",65.0,0.745673,"Both NRS scores for post-anesthesia care unit and NRS rest scores for 1st hours were lower in Group ESPB (p < 0.001 and p = 0.033, respectively).","[{'ForeName': 'Burhan', 'Initials': 'B', 'LastName': 'Dost', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey. Electronic address: burhandost@hotmail.com.'}, {'ForeName': 'Cengiz', 'Initials': 'C', 'LastName': 'Kaya', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey.'}, {'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Ozdemir', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey.'}, {'ForeName': 'Yasemin Burcu', 'Initials': 'YB', 'LastName': 'Ustun', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey.'}, {'ForeName': 'Ersin', 'Initials': 'E', 'LastName': 'Koksal', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey.'}, {'ForeName': 'Sezgin', 'Initials': 'S', 'LastName': 'Bilgin', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey.'}, {'ForeName': 'Yakup', 'Initials': 'Y', 'LastName': 'Bostancı', 'Affiliation': 'Department of Urology, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2021.110277'] 3235,33838534,Perioperative high inspired oxygen fraction induces atelectasis in patients undergoing abdominal surgery: A randomized controlled trial.,"STUDY OBJECTIVE We evaluated the feasibility of use and effects on postoperative atelectasis and complications of lower inspired oxygen fraction (FIO 2 ) compared to conventional oxygen therapy. DESIGN Single center, randomized clinical trial. SETTING University hospital, operating room and postoperative recovery area. PATIENTS One hundred ninety patients aged ≥50 with an American Society of Anesthesiologists physical status of I-III who underwent abdominal surgery with general anesthesia. INTERVENTIONS Participants were randomly assigned to either the low FIO 2 group (intraoperative: FIO 2 0.35, during induction and recovery: FIO 2 0.7) or the conventional FIO 2 group (intraoperative: FIO 2 0.6, during induction and recovery: FIO 2 1.0). MEASUREMENTS The primary outcome was postoperative atelectasis measured with lung ultrasonography at postoperative 30 min in the post-anesthesia care unit (consolidation score: each region 0-3, 12 region, total score range of 0 to 36, a lower score indicating better aeration). MAIN RESULTS Seven patients in the low FIO 2 group were omitted from the study due to changing FIO 2 during intervention (7/95 (8.4%) vs. 2/95 (2.1%), p = 0.088; low FIO 2 group vs. conventional FIO 2 group). Overall, atelectasis was detected in 29.7% (51/172) of patients 30 min after surgery by lung ultrasound and 40.1% (69/172) of patients after 2 days after surgery by chest X-ray. The scores of lung ultrasonography and the incidence of significant atelectasis (consolidation score ≥ 2 at any region) were lower in the low FIO 2 group than in the conventional FIO 2 group (median [IQR]: 3 [1,6] vs. 7 [3,9], p < 0.001 and 17/85 (20%) vs. 34/87 (39%), RR: 0.512 [95% CI: 0.311-0.843], p = 0.006, respectively). The incidence of surgical site infection and length of hospitalization were not significantly different between the two groups. CONCLUSIONS Based on our findings, decreased inspired oxygen fraction during anesthesia and recovery did not cause hypoxic events, but instead reduced immediate postoperative atelectasis. The use of intraoperative conventional higher inspired oxygen did not afford any clinical advantages for postoperative recovery in abdominal surgery.",2021,"Overall, atelectasis was detected in 29.7% (51/172) of patients 30 min after surgery by lung ultrasound and 40.1% (69/172) of patients after 2 days after surgery by chest X-ray.","['One hundred ninety patients aged ≥50 with an American Society of Anesthesiologists physical status of I-III who underwent abdominal surgery with general anesthesia', 'University hospital, operating room and postoperative recovery area', 'patients undergoing abdominal surgery']","['conventional oxygen therapy', 'low FIO 2 group (intraoperative: FIO 2 0.35, during induction and recovery: FIO 2 0.7) or the conventional FIO 2 group (intraoperative', 'intraoperative conventional higher inspired oxygen', 'Perioperative high inspired oxygen fraction']","['incidence of surgical site infection and length of hospitalization', 'scores of lung ultrasonography and the incidence of significant atelectasis (consolidation score\xa0≥\xa02 at any region', 'postoperative atelectasis measured with lung ultrasonography at postoperative 30\xa0min in the post-anesthesia care unit (consolidation score: each region 0-3, 12 region, total score range of 0 to 36, a lower score indicating better aeration', 'Overall, atelectasis', 'inspired oxygen fraction']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C4517451', 'cui_str': '0.35'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0203463', 'cui_str': 'Ultrasonography of lung'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0004144', 'cui_str': 'Atelectasis'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0340074', 'cui_str': 'Postoperative atelectasis'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]",190.0,0.382415,"Overall, atelectasis was detected in 29.7% (51/172) of patients 30 min after surgery by lung ultrasound and 40.1% (69/172) of patients after 2 days after surgery by chest X-ray.","[{'ForeName': 'MiHye', 'Initials': 'M', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine in Seoul, South Korea.'}, {'ForeName': 'Kangha', 'Initials': 'K', 'LastName': 'Jung', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine in Seoul, South Korea.'}, {'ForeName': 'Woo Seog', 'Initials': 'WS', 'LastName': 'Sim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine in Seoul, South Korea.'}, {'ForeName': 'Duk Kyung', 'Initials': 'DK', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine in Seoul, South Korea.'}, {'ForeName': 'In Sun', 'Initials': 'IS', 'LastName': 'Chung', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine in Seoul, South Korea.'}, {'ForeName': 'Ji Won', 'Initials': 'JW', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine in Seoul, South Korea.'}, {'ForeName': 'Eun Jee', 'Initials': 'EJ', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine in Seoul, South Korea.'}, {'ForeName': 'Nam Young', 'Initials': 'NY', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine in Seoul, South Korea.'}, {'ForeName': 'Jie Ae', 'Initials': 'JA', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine in Seoul, South Korea. Electronic address: jieae.kim@samsung.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2021.110285'] 3236,33838307,Design and methods of a multi-site randomized controlled trial of an integrated care model of long-acting injectable buprenorphine with infectious disease treatment among persons hospitalized with infections and opioid use disorder.,"BACKGROUND Hospitalization with co-occurring opioid use disorder (OUD) and infections presents a critical time to intervene to improve outcomes for these intertwined epidemics that are typically managed separately. A surge in life-threatening infectious diseases associated with injection drug use, including bacterial and fungal infections, HIV, and HCV accounts for substantial healthcare utilization, morbidity, and mortality. Infectious Disease (ID) specialists manage severe infections that require hospitalization and are a logical resource to engage patients in medication treatment for OUD (MOUD). An injectable long-acting monthly formulation of buprenorphine (LAB) has a potential advantage for initiating MOUD within hospital settings and bridging to treatment after discharge. METHODS A randomized multi-site trial tests a new model of care (ID/LAB) in which OUD and infections are managed by ID specialists and hospitalists using LAB coupled with referrals to community resources for long-term MOUD. A sample of 200 adults admitted to three U.S. hospitals for OUD and infections are randomly assigned 1:1 to ID/LAB or treatment as usual (TAU). The primary outcome measure is the proportion of patients enrolled in effective MOUD at 12 weeks after randomization. Secondary outcomes include relapse to opioid use, adherence to infectious disease treatment, infection morbidity and mortality, and drug overdose. RESULTS We describe the design, procedures, statistical analysis, and early implementation issues of this randomized trial. CONCLUSIONS Study findings will provide insight into the feasibility and effectiveness of integrated treatment of OUD and serious infections and have the potential to reduce morbidity and mortality in this vulnerable population.",2021,"Secondary outcomes include relapse to opioid use, adherence to infectious disease treatment, infection morbidity and mortality, and drug overdose. ","['200 adults admitted to three U.S. hospitals for OUD and infections', 'persons hospitalized with infections and opioid use disorder']","['buprenorphine (LAB', 'integrated care model of long-acting injectable buprenorphine', 'LAB or treatment as usual (TAU']","['relapse to opioid use, adherence to infectious disease treatment, infection morbidity and mortality, and drug overdose', 'proportion of patients enrolled in effective MOUD']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3469597', 'cui_str': 'Administration of medication'}]",200.0,0.128949,"Secondary outcomes include relapse to opioid use, adherence to infectious disease treatment, infection morbidity and mortality, and drug overdose. ","[{'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Seval', 'Affiliation': 'Yale School of Medicine, Department of Internal Medicine, Section of Infectious Disease, Yale AIDS Program, New Haven, CT, USA.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Frank', 'Affiliation': 'Yale School of Medicine, Department of Internal Medicine, Section of Infectious Disease, Yale AIDS Program, New Haven, CT, USA.'}, {'ForeName': 'Alain H', 'Initials': 'AH', 'LastName': 'Litwin', 'Affiliation': 'University of South Carolina School of Medicine Greenville, Prisma Health: Upstate Affiliate, Department of Infectious Disease, Greenville, SC, USA; Department of Medicine, University of South Carolina School of Medicine- Greenville, Greenville, SC, USA.'}, {'ForeName': 'Prerana', 'Initials': 'P', 'LastName': 'Roth', 'Affiliation': 'University of South Carolina School of Medicine Greenville, Prisma Health: Upstate Affiliate, Department of Infectious Disease, Greenville, SC, USA.'}, {'ForeName': 'Meredith A', 'Initials': 'MA', 'LastName': 'Schade', 'Affiliation': 'Penn State Milton S. Hershey Medical Center, Department of Medicine, Division of Infectious Diseases, Hershey, PA, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': 'Columbia University Mailman School of Public Health, Department of Biostatistics, New York, NY, USA.'}, {'ForeName': 'Frances R', 'Initials': 'FR', 'LastName': 'Levin', 'Affiliation': 'College of Physicians and Surgeons of Columbia University, New York State Psychiatric Institute/Division on Substance Use Disorders, New York, NY, USA.'}, {'ForeName': 'Kathleen T', 'Initials': 'KT', 'LastName': 'Brady', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'College of Physicians and Surgeons of Columbia University, New York State Psychiatric Institute/Division on Substance Use Disorders, New York, NY, USA.'}, {'ForeName': 'Sandra A', 'Initials': 'SA', 'LastName': 'Springer', 'Affiliation': 'Yale School of Medicine, Department of Internal Medicine, Section of Infectious Disease, Yale AIDS Program, New Haven, CT, USA. Electronic address: Sandra.springer@yale.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106394'] 3237,33838224,Therapeutic plasma exchange in patients with life-threatening COVID-19: a randomized control clinical trial.,"OBJECTIVE To assess the efficacy of therapeutic plasma exchange (TPE) following life-threatening COVID-19. DESIGN, SETTING, AND PARTICIPANTS Open-label, randomized clinical trial of intensive care unit (ICU) patients with life-threatening COVID-19 [positive real-time-polymerase-chain-reaction test, plus acute respiratory distress syndrome (ARDS), sepsis, organ failure, hyperinflammation]. The study was terminated after 87/120 patients were enrolled. INTERVENTION AND RANDOMIZATION Standard treatment plus TPE (n = 43) versus standard treatment (n = 44), and stratified by peripheral arterial oxygen saturation/fraction of inspired oxygen (PaO 2 /FiO 2 ) ratio (> 150 versus ≤ 150). MAIN OUTCOMES AND MEASURES Primary outcomes were 35-day mortality and TPE safety. Secondary outcomes were association between TPE and mortality, improvement in Sequential Organ Function Assessment (SOFA) score, change in inflammatory biomarkers, days on mechanical ventilation (MV), and ICU length-of-stay. RESULTS Eighty-seven patients [median years of age 49 (IQR: 34-63); 72 males (82.8%)] were randomized [44 to standard care; 43 to standard care plus TPE]. Days on MV (p=0.007) and ICU length-of-stay (p=0.02) were lower in the TPE group versus controls. Thirty-five-day mortality was lower in the TPE group (20.9% vs. 34.1% in controls), but this did not reach statistical significance [Kaplan-Meir analysis: p=0.582). TPE was associated with increased lymphocytes and ADAMTS-13 activity; plus decreased serum lactate, lactate dehydrogenase, ferritin, D-dimers, and interleukin-6. Multivariable regression analysis provided several predictors of 35-day mortality: PaO 2 /FiO 2 ratio [hazard ratio (HR): 0.98, 95% CI: 0.96-1.00, p=0.02], ADAMTS-13 activity (HR: 0.89, 95% CI: 0.82-0.98, p=0.01), and PE (HR: 3.57, 95% CI: 1.43-8.92, p=0.007). Post-hoc analysis revealed a significant reduction in SOFA score for TPE patients (p<0.05) compared to controls. CONCLUSION In critically ill COVID-19 patients the addition of TPE to standard ICU therapy was associated with faster clinical recovery and no increased 35-day mortality.",2021,"TPE was associated with increased lymphocytes and ADAMTS-13 activity; plus decreased serum lactate, lactate dehydrogenase, ferritin, D-dimers, and interleukin-6.","['Eighty-seven patients [median years of age 49 (IQR: 34-63); 72 males (82.8', '87/120 patients were enrolled', 'patients with life-threatening COVID-19', 'intensive care unit (ICU) patients with life-threatening COVID-19 [positive real-time-polymerase-chain-reaction test, plus acute respiratory distress syndrome (ARDS), sepsis, organ failure, hyperinflammation']","['TPE', 'standard care plus TPE', 'standard treatment (n\u202f=\u202f44), and stratified by peripheral arterial oxygen saturation/fraction of inspired oxygen (PaO 2 /FiO 2 ) ratio (> 150 versus ≤ 150', 'therapeutic plasma exchange (TPE', 'TPE to standard ICU therapy']","['SOFA score', 'increased lymphocytes and ADAMTS-13 activity; plus decreased serum lactate, lactate dehydrogenase, ferritin, D-dimers, and interleukin-6', 'ICU length-of-stay', 'TPE and mortality, improvement in Sequential Organ Function Assessment (SOFA) score, change in inflammatory biomarkers, days on mechanical ventilation (MV), and ICU length-of-stay', '35-day mortality', '35-day mortality: PaO 2 /FiO 2 ratio [hazard ratio (HR', '35-day mortality and TPE safety', 'ADAMTS-13 activity']","[{'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}]","[{'cui': 'C0032113', 'cui_str': 'Plasma exchange'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0853698', 'cui_str': 'Increased blood lymphocyte number'}, {'cui': 'C0389918', 'cui_str': 'ADAMTS13 protein, human'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0428446', 'cui_str': 'Serum lactate measurement'}, {'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032113', 'cui_str': 'Plasma exchange'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.19362,"TPE was associated with increased lymphocytes and ADAMTS-13 activity; plus decreased serum lactate, lactate dehydrogenase, ferritin, D-dimers, and interleukin-6.","[{'ForeName': 'Fahad', 'Initials': 'F', 'LastName': 'Faqihi', 'Affiliation': 'Critical Care Department, King Saud Medical City, Riyadh, Kingdom of Saudi Arabia. Electronic address: dr.faqihi677@gmail.com.'}, {'ForeName': 'Abdulrahman', 'Initials': 'A', 'LastName': 'Alharthy', 'Affiliation': 'Critical Care Department, King Saud Medical City, Riyadh, Kingdom of Saudi Arabia. Electronic address: a_almshal@hotmail.com.'}, {'ForeName': 'Salman', 'Initials': 'S', 'LastName': 'Abdulaziz', 'Affiliation': 'Critical Care Department, King Saud Medical City, Riyadh, Kingdom of Saudi Arabia. Electronic address: dr-salman@hotmail.com.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Balhamar', 'Affiliation': 'Critical Care Department, King Saud Medical City, Riyadh, Kingdom of Saudi Arabia. Electronic address: abdullahbalahmar@gmail.com.'}, {'ForeName': 'Awad', 'Initials': 'A', 'LastName': 'Alomari', 'Affiliation': 'Department of Critical care, Dr. Sulaiman Al-Habib Group Hospitals, Riyadh, Saud Arabia. Electronic address: dr_awad_ksa@yahooo.com.'}, {'ForeName': 'Zohair', 'Initials': 'Z', 'LastName': 'AlAseri', 'Affiliation': 'Departments of Emergency Medicine and Critical Care Medicine, King Saud University, Riyadh, Saudi Arabia. Electronic address: zohairalaseri@yahoo.com.'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Tamim', 'Affiliation': 'Biostatistics Unit, Clinical Research Institute, American University of Beirut Medical Center, Beirut, Lebanon. Electronic address: htamim@aub.edu.lb.'}, {'ForeName': 'Saleh A', 'Initials': 'SA', 'LastName': 'Alqahtani', 'Affiliation': 'Division of Gastroenterology & Hepatology, Johns Hopkins University, Baltimore, Maryland, USA; Liver Transplant Center, and Biostatistics, Epidemiology, and Scientific Computing Department, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia. Electronic address: salqaht1@jhmi.edu.'}, {'ForeName': 'Demetrios J', 'Initials': 'DJ', 'LastName': 'Kutsogiannis', 'Affiliation': 'Department of Critical Care, Faculty of Medicine and Dentistry, the University of Alberta, Alberta, Canada. Electronic address: djk3@ualberta.ca.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Brindley', 'Affiliation': 'Department of Critical Care, Faculty of Medicine and Dentistry, the University of Alberta, Alberta, Canada. Electronic address: Peter.Brindley@albertahealthservices.ca.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Karakitsos', 'Affiliation': 'Critical Care Department, King Saud Medical City, Riyadh, Kingdom of Saudi Arabia; Department of Internal Medicine, South Carolina University, School of Medicine, Columbia, SC, USA; Critical Care Department, Keck Medical School, University of Southern California, Los Angeles, CA, USA. Electronic address: karakitsosdimitrios@gmail.com.'}, {'ForeName': 'Ziad A', 'Initials': 'ZA', 'LastName': 'Memish', 'Affiliation': 'Research & Innovation Centre, King Saud Medical City, Riyadh, Saudi Arabia; Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA, USA. Electronic address: zmemish@yahoo.com.'}]",International journal of antimicrobial agents,['10.1016/j.ijantimicag.2021.106334'] 3238,33838159,A Diagnostic randomised controlled trial to study the impact of Rapid diagnostic tests in patients with Acute febrile illness when compared to Conventional diagnostics (DRACO study).,,2021,,['patients with Acute febrile illness'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0743842', 'cui_str': 'Acute febrile illness'}]",[],[],,0.155193,,"[{'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Gupta', 'Affiliation': 'Department of Infectious Diseases, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India, 576104; Manipal Center for Infectious Diseases, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, Karnataka, India, 576104. Electronic address: nityanitingupta@gmail.com.'}, {'ForeName': 'Sowmya', 'Initials': 'S', 'LastName': 'Joylin', 'Affiliation': 'Department of Infectious Diseases, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India, 576104.'}, {'ForeName': 'Prthvishree', 'Initials': 'P', 'LastName': 'Ravindra', 'Affiliation': 'Department of Emergency Medicine, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India, 576104.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Wilson', 'Affiliation': 'Department of Emergency Medicine, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India, 576104.'}, {'ForeName': 'Rachana', 'Initials': 'R', 'LastName': 'Bhat', 'Affiliation': 'Department of Emergency Medicine, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India, 576104.'}, {'ForeName': 'Vasudev', 'Initials': 'V', 'LastName': 'Guddattu', 'Affiliation': 'Department of Statistics, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, Karnataka, India, 576104.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Neumayr', 'Affiliation': 'University of Basel, Basel, Switzerland; Department of Public Health and Tropical Medicine, College of Public Health, Medical and Veterinary Sciences, James Cook University, Queensland, Australia.'}, {'ForeName': 'Chiranjay', 'Initials': 'C', 'LastName': 'Mukhopadhyay', 'Affiliation': 'Department of Microbiology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India, 576104.'}, {'ForeName': 'Kavitha', 'Initials': 'K', 'LastName': 'Saravu', 'Affiliation': 'Department of Infectious Diseases, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India, 576104; Manipal Center for Infectious Diseases, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, Karnataka, India, 576104.'}]",The Journal of infection,['10.1016/j.jinf.2021.04.001'] 3239,33838141,The Effect of a Psychologically-Informed Intervention to Treat Adolescents with Patellofemoral Pain: A Randomized Controlled Trial.,"OBJECTIVE To determine if the addition of a brief psychologically-informed video to traditional physical therapy influenced function (primary aim), pain, and psychological beliefs (secondary aims) among adolescents with patellofemoral pain (PFP). DESIGN Double-blind randomized controlled trial. SETTING Outpatient physical therapy clinics of a single pediatric hospital. PARTICIPANTS Sixty-six adolescents with PFP (14.8 ± 1.7 years old, 65% female). INTERVENTION Adolescents were randomly assigned to view a brief psychologically-informed video (n=34) or control video (n=32). The psychologically-informed video targeted pain-related fear and pain catastrophizing, and the control video related basic anatomy and factors involved in PFP. MAIN OUTCOMES The primary outcome was change in function (Anterior Knee Pain Scale). Secondary outcomes were change in psychological beliefs (fear-avoidance beliefs, kinesiophobia, and pain catastrophizing), and pain. Outcomes were assessed at baseline, immediately post-intervention, 2 weeks, 6 weeks, and 3 months. RESULTS Using a two-way mixed analysis of variance, change in function in the intervention group was greater than the control group with a moderate treatment effect noted (p = 0.001, partial η 2  = 0.1). Post-hoc testing revealed that there was a significant interaction between the intervention and time from baseline to two weeks, but no interaction was noted between two weeks and three months. The psychologically-informed video significantly reduced maladaptive psychological beliefs (p = 0.01, η 2  = 0.32). No significant between-group differences in pain were noted. CONCLUSION Incorporating a brief one-time psychologically-informed video into standard physical therapy care significantly reduced pain-related fear, pain catastrophizing and improved function among adolescents with PFP. The immediate effect noted on function did not continue throughout the course of care.",2021,"The psychologically-informed video significantly reduced maladaptive psychological beliefs (p = 0.01, η 2  = 0.32).","['adolescents with PFP', 'Outpatient physical therapy clinics of a single pediatric hospital', 'adolescents with patellofemoral pain (PFP', 'Sixty-six adolescents with PFP (14.8 ± 1.7 years old, 65% female', 'Adolescents with Patellofemoral Pain']","['brief psychologically-informed video (n=34) or control video', 'brief psychologically-informed video to traditional physical therapy', 'Psychologically-Informed Intervention']","['maladaptive psychological beliefs', 'pain-related fear, pain catastrophizing and improved function', 'pain', 'change in function (Anterior Knee Pain Scale', 'pain, and psychological beliefs', 'change in psychological beliefs (fear-avoidance beliefs, kinesiophobia, and pain catastrophizing), and pain']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0409326', 'cui_str': 'Anterior knee pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}]",66.0,0.23275,"The psychologically-informed video significantly reduced maladaptive psychological beliefs (p = 0.01, η 2  = 0.32).","[{'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Selhorst', 'Affiliation': ""Sports and Orthopedic Physical Therapy, Nationwide Children's Hospital, Columbus, Ohio, United States. Electronic address: Mitchell.Selhorst@Nationwidechildrens.org.""}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Fernandez-Fernandez', 'Affiliation': 'Department of Physical Therapy, Nova Southeastern University, Fort Lauderdale, Florida, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Schmitt', 'Affiliation': 'Jameson Crane Sports Medicine Research Institute, Ohio State University Wexner Medical Center, Columbus, Ohio, United States; Division of Physical Therapy, School of Health and Rehabilitation Sciences, Ohio State University, Columbus, Ohio, United States.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Hoehn', 'Affiliation': ""Department of Pediatric Psychology and Neuropsychology, Nationwide Children's Hospital, Columbus, Ohio, United States.""}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2021.03.016'] 3240,33830960,Impact of Residual Subretinal Fluid Volumes on Treatment Outcomes in a SRF-tolerant Treat & Extend Regimen.,"PURPOSE To investigate associations between residual subretinal fluid (rSRF) volumes, quantified using artificial intelligence (AI) and treatment outcomes in a SRF-tolerant treat-and-extend (T&E) regimen in neovascular age-related macular degeneration (nAMD). METHODS Patients enrolled in the prospective, multicenter FLUID study randomized in a SRF-tolerant T&E regimen were examined by SD-OCT and tested for BCVA. SRF and intraretinal fluid (IRF) volumes were quantified using AI-tools. 375 visits of 98 patients were divided into subgroups: extended intervals despite rSRF, and extended intervals without fluid. Associations between BCVA-change, SRF-volume, subgroups and treatment intervals were estimated using linear mixed models. RESULTS In extended intervals despite rSRF, increased SRF was associated with reduced BCVA at the next visit in the central 1mm (-0.138 letters/nl; p=0.014) and 6mm (-0.024 letters/nl; p=0.049). A negative association between increased interval and BCVA change was found for rSRF in 1 and 6mm (-0.250 and -0.233 letter/week interval, respectively, both p<0.001). Extended intervals despite rSRF had significantly higher SRF-volumes in the central 6mm at the following visit (p=0.002). CONCLUSION AI-based analysis of extended visits despite rSRF demonstrated increasing SRF-volumes associated with BCVA loss at the consecutive visit. This negative association contributes to our understanding of rSRF volumes on treatment outcomes in nAMD.",2021,"Extended intervals despite rSRF had significantly higher SRF-volumes in the central 6mm at the following visit (p=0.002). ","['Patients enrolled in the prospective, multicenter FLUID study randomized in a', '375 visits of 98 patients', 'neovascular age-related macular degeneration (nAMD']","['SRF-tolerant treat-and-extend (T&E) regimen', 'SRF-tolerant T&E']","['interval and BCVA change', 'SRF', 'SRF-volumes', 'SRF and intraretinal fluid (IRF) volumes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}]","[{'cui': 'C0037668', 'cui_str': 'Somatotropin releasing factor'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0037668', 'cui_str': 'Somatotropin releasing factor'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C4531067', 'cui_str': 'Intraretinal fluid'}]",,0.197635,"Extended intervals despite rSRF had significantly higher SRF-volumes in the central 6mm at the following visit (p=0.002). ","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Grechenig', 'Affiliation': 'Christian Doppler Laboratory for Ophthalmic Image Analysis, Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria Marsden Eye Specialists, Parramatta, Australia Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, and Department of Surgery (Ophthalmology), University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Gregor S', 'Initials': 'GS', 'LastName': 'Reiter', 'Affiliation': ''}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Riedl', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Arnold', 'Affiliation': ''}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Guymer', 'Affiliation': ''}, {'ForeName': 'Bianca S', 'Initials': 'BS', 'LastName': 'Gerendas', 'Affiliation': ''}, {'ForeName': 'Hrvoje', 'Initials': 'H', 'LastName': 'Bogunović', 'Affiliation': ''}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Schmidt-Erfurth', 'Affiliation': ''}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000003180'] 3241,33830898,A pilot study to evaluate micro-fragmented adipose tissue injection under ultrasound guidance for the treatment of refractory rotator cuff disease in wheelchair users with spinal cord injury.,"CONTEXT/OBJECTIVES Wheelchair users with chronic shoulder pain have few options after conservative treatments fail. This pilot study's purpose was to establish safety and treatment effects of micro-fragmented adipose tissue (MFAT) injections under ultrasound guidance for treatment of refractory shoulder pain caused by rotator cuff disease in wheelchair users with spinal cord injury (SCI) to prepare for a larger trial. DESIGN Pilot clinical trial. SETTING Rehabilitation hospital outpatient clinic. PARTICIPANTS Ten wheelchair users with chronic SCI who had moderate-to-severe shoulder pain caused by refractory rotator cuff disease (diagnosed via ultrasound) for greater than 6 months. INTERVENTIONS Ultrasound-guided injections of MFAT into the pathologic rotator cuff tendons and other abnormal shoulder structures (e.g. acromioclavicular and glenohumeral joints; subacromial bursa). OUTCOME MEASURES 6- and 12-month changes in 11-point Numerical Rating Scale (NRS); Wheelchair User's Shoulder Pain Index (WUSPI); Brief Pain Inventory pain interference items (BPI-I7); Patient Global Impression of Change (PGIC); ultrasound and physical exams; and adverse events. CONCLUSIONS There were no significant adverse events throughout the study period. WUSPI, NRS, and BPI-I7 scores were significantly lower 6 and 12 months post-procedure (P < .05). Of those who remained in the trial, clinically meaningful changes (≥30% decrease) in WUSPI, NRS, and BPI-I7 scores were observed in 77.8%, 77.8%, and 66.7% of participants, respectively. All but one participant reported improvement in clinical status. MFAT injection under ultrasound guidance is potentially a safe and efficacious treatment for refractory shoulder pain caused by rotator cuff disease in wheelchair users with SCI. A larger, randomized controlled trial has been initiated. Trial registration : ClinicalTrials.gov identifier: NCT03167138.",2021,MFAT injection under ultrasound guidance is potentially a safe and efficacious treatment for refractory shoulder pain caused by rotator cuff disease in wheelchair users with SCI.,"['Wheelchair users with chronic shoulder pain', 'wheelchair users with spinal cord injury (SCI', 'Rehabilitation hospital outpatient clinic', 'wheelchair users with spinal cord injury', 'Ten wheelchair users with chronic SCI who had moderate-to-severe shoulder pain caused by refractory rotator cuff disease (diagnosed via ultrasound) for greater than 6 months']","['Ultrasound-guided injections of MFAT', 'micro-fragmented adipose tissue (MFAT) injections under ultrasound guidance', 'MFAT injection under ultrasound guidance', 'micro-fragmented adipose tissue injection under ultrasound guidance']","['adverse events', 'WUSPI, NRS, and BPI-I7 scores', ""Wheelchair User's Shoulder Pain Index (WUSPI); Brief Pain Inventory pain interference items (BPI-I7); Patient Global Impression of Change (PGIC); ultrasound and physical exams; and adverse events"", '11-point Numerical Rating Scale (NRS']","[{'cui': 'C0853966', 'cui_str': 'Wheelchair user'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0853966', 'cui_str': 'Wheelchair user'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.102314,MFAT injection under ultrasound guidance is potentially a safe and efficacious treatment for refractory shoulder pain caused by rotator cuff disease in wheelchair users with SCI.,"[{'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Hogaboom', 'Affiliation': 'Kessler Foundation, West Orange, New Jersey, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Malanga', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Rutgers New Jersey Medical School, Newark, New Jersey, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Cherian', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Rutgers New Jersey Medical School, Newark, New Jersey, USA.'}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Dyson-Hudson', 'Affiliation': 'Kessler Foundation, West Orange, New Jersey, USA.'}]",The journal of spinal cord medicine,['10.1080/10790268.2021.1903140'] 3242,33835597,Randomized controlled trials of self-monitoring interventions with or without incentives for diet and exercise among individuals with overweight or obesity: Psychological and behavioural effects.,"OBJECTIVES To test the effects of three behavioural interventions (daily monetary incentives + self-monitoring, delayed lump sum monetary incentives + self-monitoring, and self-monitoring only) on psychological constructs and fruit and vegetable consumption or physical activity behaviour change among a sample of adults with overweight or obesity. DESIGN A pair of 3-arm longitudinal randomized controlled trials compared daily monetary incentives + self-monitoring, delayed lump sum monetary incentives + self-monitoring, and self-monitoring only interventions for either fruit and vegetable consumption or physical activity. METHODS Individuals reporting elevated weight status and insufficient engagement in one of the target behaviours were randomly assigned to one of three 3-week interventions. All three interventions involved daily self-monitoring of the behaviour, and two provided monetary incentives contingent upon reported behaviour. Participants completed measures of psychological constructs and reported behaviour at baseline, the end of the intervention, and two and four weeks post-intervention. RESULTS Participants across all three intervention conditions demonstrated increased engagement in the target behaviour from pre- to post-intervention and reported behaviour remained above baseline levels at both follow-up time points. Increases in reported behaviour during the intervention were associated with increases in self-efficacy, and this enhanced self-efficacy prospectively predicted sustained reported behaviour at follow-up. However, contrary to hypotheses, the incentive interventions including self-monitoring were not more efficacious than self-monitoring alone, and increased reported behaviour was not associated with enhancements in attitudes. CONCLUSIONS Self-monitoring interventions can aid behaviour change efforts, and behavioural practice during these interventions can increase self-efficacy. However, among adults with overweight or obesity who are seeking behaviour change interventions, incentive-based self-monitoring approaches may not be superior to self-monitoring alone in driving behaviour change and maintenance.",2021,"However, contrary to hypotheses, the incentive interventions including self-monitoring were not more efficacious than self-monitoring alone, and increased reported behaviour was not associated with enhancements in attitudes. ","['Individuals reporting elevated weight status and insufficient engagement in one of the target behaviours', 'individuals with overweight or obesity', 'adults with overweight or obesity']","['self-monitoring interventions with or without incentives for diet and exercise', 'behavioural interventions (daily monetary incentives\xa0+\xa0self-monitoring, delayed lump sum monetary incentives\xa0+\xa0self-monitoring, and self-monitoring only) on psychological constructs and fruit and vegetable consumption or physical activity behaviour change', 'daily monetary incentives\xa0+\xa0self-monitoring, delayed lump sum monetary incentives\xa0+\xa0self-monitoring, and self-monitoring only interventions for either fruit and vegetable consumption or physical activity']","['psychological constructs and reported behaviour', 'self-efficacy']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.0364455,"However, contrary to hypotheses, the incentive interventions including self-monitoring were not more efficacious than self-monitoring alone, and increased reported behaviour was not associated with enhancements in attitudes. ","[{'ForeName': 'Casey K', 'Initials': 'CK', 'LastName': 'Gardiner', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado Boulder, Colorado, USA.'}, {'ForeName': 'Angela D', 'Initials': 'AD', 'LastName': 'Bryan', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado Boulder, Colorado, USA.'}]",British journal of health psychology,['10.1111/bjhp.12523'] 3243,33835497,Buprenorphine may be effective for treatment of paramyotonia congenita.,"INTRODUCTION/AIMS Paramyotonia congenita (PMC) is a skeletal muscle sodium channelopathy characterized by paradoxical myotonia, cold sensitivity, exercise/cold induced paralysis. Treatment with sodium channel-blocking anti-arrhythmics may expose the patients to a risk of arrhythmia or may be poorly tolerated or ineffective. We explored the effectiveness of non-anti-arrhythmic sodium channel blockers in two patients with PMC. METHODS Previous treatment with mexiletine was discontinued for gastrointestinal side effects in one patient and lack of clinical benefit in the other. One patient received lacosamide, ranolazine and buprenorphine, the other patient buprenorphine only. The efficacy was assessed by clinical scores, timed tests, and by long and short exercise tests. RESULTS In both patients, buprenorphine improved by at least 50% scores of pain, stiffness and weakness, and handgrip/eyelid opening times. The fall in compound muscle action potential (CMAP) during short exercise normalized in both patients at baseline, and improved after cooling. During long exercise, one patient showed an earlier recovery of CMAP, the other a less severe fall (<60%). With buprenorphine, the fall in CMAP induced by cooling normalized in one patient (from -72% to -4%) and improved (from -49% to -37%) in the other. DISCUSSION Buprenorphine showed promising results for the treatment of exercise-induced paralysis and cold intolerance in our two patients. The exercise test may be useful for quantitative assessment of treatment response. Further studies on a larger number of patients, under carefully controlled conditions, should be considered to address effectiveness and long-term tolerability of this possible therapeutic option.",2021,"The fall in compound muscle action potential (CMAP) during short exercise normalized in both patients at baseline, and improved after cooling.",['two patients with PMC'],"['lacosamide, ranolazine and buprenorphine', 'sodium channel-blocking anti-arrhythmics', 'mexiletine', 'Buprenorphine', 'non-anti-arrhythmic sodium channel blockers', 'buprenorphine']","['pain, stiffness and weakness, and handgrip/eyelid opening times']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221055', 'cui_str': 'Paramyotonia congenita'}]","[{'cui': 'C0893761', 'cui_str': 'lacosamide'}, {'cui': 'C0073633', 'cui_str': 'ranolazine'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0037492', 'cui_str': 'Sodium Channel'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}, {'cui': 'C0025887', 'cui_str': 'Mexiletine'}, {'cui': 'C0872271', 'cui_str': 'Sodium channel blocker'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0015426', 'cui_str': 'Eyelid structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",2.0,0.0124704,"The fall in compound muscle action potential (CMAP) during short exercise normalized in both patients at baseline, and improved after cooling.","[{'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Ravaglia', 'Affiliation': 'IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Maggi', 'Affiliation': 'Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Zito', 'Affiliation': 'IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Sebastiano', 'Initials': 'S', 'LastName': 'Arceri', 'Affiliation': 'IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Gallotti', 'Affiliation': 'Istituto Clinico ""Beato Matteo"", Hospital Group San Donato, Vigevano, Italy.'}, {'ForeName': 'Concetta', 'Initials': 'C', 'LastName': 'Altamura', 'Affiliation': 'Sezione di Farmacologia, Dipartimento di Scienze Biomediche e Oncologia Umana, Scuola di Medicina, Università degli Studi di Bari Aldo Moro, Bari, Italy.'}, {'ForeName': 'Jean Francois', 'Initials': 'JF', 'LastName': 'Desaphy', 'Affiliation': 'Sezione di Farmacologia, Dipartimento di Scienze Biomediche e Oncologia Umana, Scuola di Medicina, Università degli Studi di Bari Aldo Moro, Bari, Italy.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Bernasconi', 'Affiliation': 'Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Alfonsi', 'Affiliation': 'IRCCS Mondino Foundation, Pavia, Italy.'}]",Muscle & nerve,['10.1002/mus.27249'] 3244,33835404,Sleep reduces the semantic coherence of memory recall: An application of latent semantic analysis to investigate memory reconstruction.,"Sleep is thought to help consolidate hippocampus-dependent memories by reactivating previously encoded neural representations, promoting both quantitative and qualitative changes in memory representations. However, the qualitative nature of changes to memory representations induced by sleep remains largely uncharacterized. In this study, we investigated how memories are reconstructed by hypothesizing that semantic coherence, defined as conceptual relatedness between statements of free-recall texts and quantified using latent semantic analysis (LSA), is affected by post-encoding sleep. Short naturalistic videos of events featuring six animals were presented to 115 participants who were randomly assigned to either 12- or 24-h delay groups featuring sleep or wakefulness. Participants' free-recall responses were analyzed to test for an effect of sleep on semantic coherence between adjacent statements, and overall. The presence of sleep reduced both forms of semantic coherence, compared to wakefulness. This change was robust and not due to shifts in conciseness or repetitiveness with sleep. These findings support the notion that sleep-dependent consolidation qualitatively changes the features of reconstructed memory representations by reducing semantic coherence.",2021,"Participants' free-recall responses were analyzed to test for an effect of sleep on semantic coherence between adjacent statements, and overall.",['Short naturalistic videos of events featuring six animals were presented to 115 participants who were randomly assigned to either 12- or 24-h delay groups featuring sleep or wakefulness'],[],['semantic coherence of memory recall'],"[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0076769', 'cui_str': 'TO 115'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}]",[],"[{'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C0679063', 'cui_str': 'Memory recall'}]",115.0,0.0662967,"Participants' free-recall responses were analyzed to test for an effect of sleep on semantic coherence between adjacent statements, and overall.","[{'ForeName': 'Xueying', 'Initials': 'X', 'LastName': 'Ren', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA, USA. xur1@pitt.edu.'}, {'ForeName': 'Marc N', 'Initials': 'MN', 'LastName': 'Coutanche', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA, USA.'}]",Psychonomic bulletin & review,['10.3758/s13423-021-01919-8'] 3245,33835230,Evaluation of clinical outcomes and efficacy of palonosetron and granisetron in combination with dexamethasone in Egyptian patients receiving highly emetogenic chemotherapy.,"BACKGROUND Chemotherapy-induced nausea and vomiting (CINV) is considered one of the most serious adverse events affecting chemotherapy-receiving cancer patients. It dramatically affects their food intake, nutritional status and more importantly their quality of life. We can observe CINV in highly emetogenic chemotherapy (HEC) such as adriamycin-cyclophosphamide combination (AC) in breast cancer patients and cisplatin-based regimens in other cancer types. This study aimed to evaluate the antiemetic efficacy of palonosetron (PALO) over granisetron (GRA) in combination with dexamethasone for multiple highly emetogenic chemotherapy drugs (HEC), especially in chemotherapy regimens in Egyptian breast cancer patients and cisplatin-based regimens in other diseases. PATIENTS AND METHODS An open-label randomized trial was carried out, including 115 patients receiving at least four cycles of highly emetogenic chemotherapy regimens. All patients received dexamethasone in combination with the 5-HT3 receptor antagonist. We recorded patients' clinical and biochemical characteristics and withdraw blood samples to monitor serum substance P and serotonin in correlation with chemotherapy-induced nausea and vomiting (CINV). We use the MASCC antiemetic tool in the acute phase (0-24 hr) and delayed phase (24-120 h) to evaluate patient outcomes in both stages after each chemotherapy cycle. RESULTS In (PALO) group, only 7.84% of patients showed acute vomiting, and 11.76% showed acute nausea, whereas 43.75% of patients showed acute vomiting and 89.06% showed acute nausea in (GRA) group (P < 0.0001). For delayed CINV, 23.53% of patients showed delayed vomiting, and 47.06% showed delayed nausea in the (PALO) group, while 82.81% of patients showed delayed emesis, and 92.19% showed delayed nausea in (GRA) group (P < 0.0001). The study showed that PALO is a cost-effective choice when compared to GRA in CINV prevention as 45.10% of patients in (PALO) required additional rescue medications (Domperidone 10 mg orally three times per day plus Trimebutine 200 mg orally three times per week both for 5 days), while 95.24% in the (GRA) group used the same medications. Adverse events of both antiemetic drugs (PALO and GRA) include headaches and constipation and QTc prolongation reports, mostly mild to moderate, with relatively low rates among the two groups. CONCLUSION Palonosetron, combined with dexamethasone, is more effective than granisetron and dexamethasone combination against both acute and delayed emesis induced by highly emetogenic chemotherapy (HEC) cisplatin-based protocols and the combination of cyclophosphamide and anthracyclines (AC). Medical team members should make more efforts, especially clinical pharmacy personnel, to monitor medications' effectiveness and help the medical team achieve a suitable and reliable care plan.",2021,"Adverse events of both antiemetic drugs (PALO and GRA) include headaches and constipation and QTc prolongation reports, mostly mild to moderate, with relatively low rates among the two groups. ","['Egyptian breast cancer patients and cisplatin-based regimens in other diseases', 'chemotherapy-receiving cancer patients', 'breast cancer patients and cisplatin-based regimens in other cancer types', '115 patients receiving at least four cycles of highly emetogenic chemotherapy regimens', 'Egyptian patients receiving highly emetogenic chemotherapy']","['dexamethasone', 'dexamethasone in combination with the 5-HT3 receptor antagonist', 'Trimebutine', 'granisetron (GRA', 'adriamycin-cyclophosphamide combination (AC', 'granisetron and dexamethasone', 'PALO', 'cyclophosphamide and anthracyclines (AC', 'emetogenic chemotherapy (HEC) cisplatin', 'palonosetron (PALO', 'palonosetron and granisetron']","['antiemetic efficacy', 'acute vomiting', 'quality of life', 'delayed vomiting', 'delayed nausea', 'delayed emesis', 'headaches and constipation and QTc prolongation', 'acute nausea', 'nausea and vomiting (CINV']","[{'cui': 'C0013717', 'cui_str': 'Egyptian language'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013973', 'cui_str': 'Emetic'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0360055', 'cui_str': '5-HT3 receptor antagonist'}, {'cui': 'C0041023', 'cui_str': 'Trimebutine'}, {'cui': 'C0061863', 'cui_str': 'Granisetron'}, {'cui': 'C0085752', 'cui_str': 'Adriamycin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C0013973', 'cui_str': 'Emetic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0232597', 'cui_str': 'Acute vomiting'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0855333', 'cui_str': 'Electrocardiogram QT corrected interval prolonged'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0401160', 'cui_str': 'Chemotherapy-induced nausea and vomiting'}]",,0.0480044,"Adverse events of both antiemetic drugs (PALO and GRA) include headaches and constipation and QTc prolongation reports, mostly mild to moderate, with relatively low rates among the two groups. ","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'A Mahrous', 'Affiliation': 'Oncology Pharmacy Department, Tanta Cancer Center, Tanta, Egypt. Mahrosmohamed14@gmail.com.'}, {'ForeName': 'Gamal', 'Initials': 'G', 'LastName': 'A El-Azab', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Hisham', 'Initials': 'H', 'LastName': 'A Tawfik', 'Affiliation': 'Medical Oncology Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-021-04257-7'] 3246,33835229,"Pharmacokinetics, safety, activity, and biomarker analysis of palbociclib plus letrozole as first-line treatment for ER+/HER2- advanced breast cancer in Chinese women.","PURPOSE This phase 1, open-label, single-arm clinical trial evaluated pharmacokinetics, safety, and biomarker activity of palbociclib-letrozole as first-line treatment for estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer (ABC) in postmenopausal Chinese women to support palbociclib approval in China. METHODS Patients received palbociclib 125 mg once daily (3/1 schedule) plus letrozole 2.5 mg once daily. Blood samples were collected predose and ≤ 120 h after single and multiple doses of palbociclib. The incidence and severity of adverse events were reported. Skin biopsy tissues and blood samples were collected for biomarker assessments. RESULTS By 31 July 2018, 26 patients were enrolled. After single and multiple dosing, palbociclib maximum plasma concentration was 82.14 and 139.7 ng/mL, apparent clearance was 52.40 and 49.97 L/h, AUC τ was 1217 and 2501 ng∙h/mL, and t ½ was 23.46 and 27.26 h, respectively. Levels of Ki67, retinoblastoma protein, and thymidine kinase decreased after palbociclib treatment. A similar safety profile as previously reported was observed. CONCLUSIONS Pharmacokinetic and pharmacodynamic effects of palbociclib were well characterized in Chinese patients with ABC. Despite higher exposure, pharmacokinetic parameters were similar to those of a previously studied non-Asian population. No palbociclib dose adjustment based on Chinese ethnicity is needed. Palbociclib-letrozole had a manageable safety profile. CLINICAL TRIAL REGISTRATION NCT02499146.",2021,"Levels of Ki67, retinoblastoma protein, and thymidine kinase decreased after palbociclib treatment.","['postmenopausal Chinese women to support palbociclib approval in China', 'ER+/HER2- advanced breast cancer in Chinese women', 'By 31 July 2018, 26 patients were enrolled', 'Chinese patients with ABC']","['palbociclib 125\xa0mg once daily (3/1 schedule) plus letrozole 2.5\xa0mg once daily', 'palbociclib plus letrozole', 'palbociclib-letrozole', 'Palbociclib-letrozole']","['palbociclib maximum plasma concentration', 'Skin biopsy tissues and blood samples', 'Levels of Ki67, retinoblastoma protein, and thymidine kinase', 'incidence and severity of adverse events', 'manageable safety profile', 'Pharmacokinetics, safety, activity, and biomarker analysis']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3883501', 'cui_str': 'palbociclib 125 MG [Ibrance]'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0987086', 'cui_str': 'letrozole 2.5 MG'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}]","[{'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0150866', 'cui_str': 'Biopsy of skin'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0080113', 'cui_str': 'Rb Gene Product'}, {'cui': 'C0040078', 'cui_str': 'Thymidine kinase'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",26.0,0.105786,"Levels of Ki67, retinoblastoma protein, and thymidine kinase decreased after palbociclib treatment.","[{'ForeName': 'Binghe', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'National Cancer Center, National Clinical Research Center for Cancer, State Key Laboratory of Molecular Oncology/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Xubinghe@medmail.com.cn.'}, {'ForeName': 'Huiping', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Breast Oncology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Qingyuan', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Harbin Medical University Cancer Hospital, Heilongjiang Province, China.'}, {'ForeName': 'Wan', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Pfizer Inc, San Diego, CA, USA.'}, {'ForeName': 'Yanke', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Shusen', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Sun Yat-Sen University Cancer Center, Guangdong, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Liao', 'Affiliation': 'Guangdong General Hospital, Guangdong, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Shen', 'Affiliation': 'The First Affiliated Hospital of College of Medicine, Zhejiang University, Zhejiang, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Pfizer Inc, San Diego, CA, USA.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Pfizer Inc, San Diego, CA, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Linn', 'Affiliation': 'Pfizer (China) R&D Co., Ltd, Shanghai, China.'}, {'ForeName': 'Huadong', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Pfizer Inc, San Diego, CA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Pfizer Inc, San Diego, CA, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Pfizer Inc, San Diego, CA, USA. Diane.Wang@Pfizer.com.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-021-04263-9'] 3247,33835198,Wearing compression tights post-exercise enhances recovery hemodynamics and subsequent cycling performance.,"PURPOSE To investigate sports compression garment (CG)-induced recovery hemodynamics and their potential impact on subsequent cycling performance. METHODS In a randomized crossover design, 13 physically active men (20.9 ± 1.4 years; 65.9 ± 7.8 kg; 173.3 ± 4.8 cm; peak power output 254.2 ± 27.2 W) underwent 2 experimental trials. During each experimental trial, the subjects performed 20-min fatiguing preload cycling followed by 60-min passive recovery wearing either a sports CG (28.6 ± 9.4 mmHg) or gymnastic pants (CON). A 5-min all-out cycling performance test was subsequently conducted and power output and cadence were recorded. Cardiac output (CO) and stroke volume (SV) were measured using Doppler ultrasound (USCOM®). Heart rate (HR), blood lactate [BLa - ], ratings of perceived exertion (RPE), leg muscle soreness (LMS), mean arterial pressure (MAP) and systemic vascular resistance (SVR) were monitored at 5, 15, 30, 45, 60 min during passive recovery. RESULTS During the subsequent 5-min all-out cycling performance test, power output (215.2 ± 24.0 vs. 210.8 ± 21.5 W, CG vs. CON) and cadence (72.5 ± 3.8 vs. 71.2 ± 4.8 rpm, CG vs. CON) were higher in CG than CON (P < 0.05). SV was higher at 15, 30 and 45 min (P < 0.05), CO was higher at 5 and 45 min (P < 0.05), HR was lower at 15 and 30 min (P < 0.05) and [BLa - ] was lower at 5 and 15 min (P < 0.05) during passive recovery, while LMS was lower at all time-points (P < 0.05) compared with CON. CONCLUSION Sports CG improves subsequent cycling performance by enhancing hemodynamic responses and attenuating perceived muscle soreness during passive recovery in physically active men.",2021,"SV was higher at 15, 30 and 45 min (P < 0.05), CO was higher at 5 and 45 min (P < 0.05), HR was lower at 15 and 30 min (P < 0.05) and [BLa - ] was lower at 5 and 15 min (P < 0.05) during passive recovery, while LMS was lower at all time-points (P < 0.05) compared with CON. ","['13 physically active men (20.9\u2009±\u20091.4\xa0years; 65.9\u2009±\u20097.8\xa0kg; 173.3\u2009±\u20094.8\xa0cm; peak power output 254.2\u2009±\u200927.2\xa0W) underwent 2 experimental trials', 'physically active men']","['20-min fatiguing preload cycling followed by 60-min passive recovery wearing either a sports CG (28.6\u2009±\u20099.4\xa0mmHg) or gymnastic pants (CON', 'Sports CG']","['SV', 'recovery hemodynamics and subsequent cycling performance', 'subsequent cycling performance', 'HR', 'Cardiac output (CO) and stroke volume (SV', 'CO', 'Heart rate (HR), blood lactate [BLa - ], ratings of perceived exertion (RPE), leg muscle soreness (LMS), mean arterial pressure (MAP) and systemic vascular resistance (SVR']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517765', 'cui_str': '4.8'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C5191357', 'cui_str': '27.2'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C2985539', 'cui_str': 'Compression garment'}, {'cui': 'C4517679', 'cui_str': '28.6'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0018409', 'cui_str': 'Gymnastics'}, {'cui': 'C0425488', 'cui_str': 'Rapid shallow breathing'}]","[{'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0574531', 'cui_str': 'Blackfoot language'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0224456', 'cui_str': 'Skeletal muscle structure of lower leg'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}]",13.0,0.110943,"SV was higher at 15, 30 and 45 min (P < 0.05), CO was higher at 5 and 45 min (P < 0.05), HR was lower at 15 and 30 min (P < 0.05) and [BLa - ] was lower at 5 and 15 min (P < 0.05) during passive recovery, while LMS was lower at all time-points (P < 0.05) compared with CON. ","[{'ForeName': 'Daniel C W', 'Initials': 'DCW', 'LastName': 'Lee', 'Affiliation': 'Department of Sports Science and Physical Education, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Sinead', 'Initials': 'S', 'LastName': 'Sheridan', 'Affiliation': 'Department of Sports Science and Physical Education, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Ajmol', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': 'Department of Sports Science and Physical Education, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Sutanto', 'Affiliation': 'Department of Sports Science and Physical Education, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Stephen H S', 'Initials': 'SHS', 'LastName': 'Wong', 'Affiliation': 'Department of Sports Science and Physical Education, The Chinese University of Hong Kong, Shatin, Hong Kong. hsswong@cuhk.edu.hk.'}]",European journal of applied physiology,['10.1007/s00421-021-04661-0'] 3248,33835174,Effect of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Women: A Randomized Clinical Trial.,"Importance The prevention of chemotherapy-induced nausea and vomiting has an important role in the overall management of cancer treatment. Objective To evaluate whether adding aprepitant to palonosetron and dexamethasone can further prevent the incidence and severity of nausea and vomiting caused by FOLFIRI (fluorouracil, leucovorin, and irinotecan) or FOLFOX (fluorouracil, leucovorin, and oxaliplatin) chemotherapy regimens among women with gastrointestinal cancer at higher risk. Design, Setting, and Participants This phase 3, double-blind, placebo-controlled randomized clinical trial recruited young women (age ≤50 years) who drank little or no alcohol and had gastrointestinal cancer for which they received FOLFOX or FOLFIRI chemotherapy. A total of 248 women were enrolled and assigned in the ratio 1:1 to intervention and control groups from August 4, 2015, to March 31, 2020. Intention-to-treat analysis was used to evaluate patient baseline characteristics and efficacy. The analysis was conducted on October 30, 2020. Interventions Patients were randomly assigned to the aprepitant group (aprepitant, 125 mg, orally 60 minutes before initiation of chemotherapy on day 1 and 80 mg orally each morning of days 2 and 3; palonosetron, 0.25 mg, intravenously; and dexamethasone, 6 mg, orally 30 minutes before chemotherapy initiation on day 1) or the placebo group (placebo, 125 mg, orally 60 minutes before initiation of chemotherapy on day 1 and 80 mg orally on each morning of days 2 and 3; palonosetron, 0.25 mg, intravenously; and dexamethasone, 12 mg, orally 30 minutes before chemotherapy initiation on day 1). Main Outcomes and Measures The primary end point was the complete response (CR) rate, defined as the proportion of patients without emesis episodes or rescue medication use during the overall phase of the first cycle. Other efficacy indicators, such as no vomiting and no nausea, were measured as the secondary and exploratory end points. Results A total of 248 women from 4 clinical centers in China entered this study, and 243 patients (aprepitant regimen, 125 patients [51.4%]; placebo regimen, 118 patients [48.5%]) were evaluable for efficacy and safety; mean (SD) age of the total population was 40.1 (7.3) years. The CR rate was significantly higher in the aprepitant group vs the control group overall (107 [87.0%] vs 80 [66.7%]; P < .001) and in the acute (114 [92.7%] vs 91 [75.8%]; P = .001) and delayed (109 [88.6%] vs 84 [70.0%]; P = .001) phases of the trial. The incidence of adverse events was similar between the 2 groups (100 [80.0%] vs 96 [81.3%]; P = .79), and no grade 3 or 4 aprepitant treatment-related adverse events were observed. Multivariable analysis revealed that aprepitant use was the only independent factor associated with CR during the overall phase. Conclusions and Relevance The combination of aprepitant with palonosetron and dexamethasone provided increased antiemetic efficacy in the FOLFOX or FOLFIRI chemotherapy regimen and was well tolerated by younger women with gastrointestinal cancer who have a history of little or no alcohol consumption. Trial Registration ClinicalTrials.gov Identifier: NCT03674294.",2021,"The incidence of adverse events was similar between the 2 groups (100 [80.0%] vs 96 [81.3%]; P = .79), and no grade 3 or 4 aprepitant treatment-related adverse events were observed.","['Women', 'women with gastrointestinal cancer at higher risk', 'young women (age ≤50 years) who drank little or no alcohol and had gastrointestinal cancer for which they received', '248 women from 4 clinical centers in China entered this study, and 243 patients (aprepitant regimen, 125 patients [51.4', 'younger women with gastrointestinal cancer who have a history of little or no alcohol consumption', 'A total of 248 women were enrolled and assigned in the ratio 1:1 to intervention and control groups from August 4, 2015, to March 31, 2020', 'regimen, 118 patients [48.5%]) were evaluable for efficacy and safety; mean (SD) age of the total population was 40.1 (7.3) years']","['placebo group (placebo', 'FOLFOX or FOLFIRI chemotherapy', 'aprepitant group (aprepitant, 125 mg, orally 60 minutes before initiation of chemotherapy', 'placebo', 'palonosetron and dexamethasone', 'palonosetron, 0.25 mg, intravenously; and dexamethasone', 'FOLFIRI (fluorouracil, leucovorin, and irinotecan) or FOLFOX (fluorouracil, leucovorin, and oxaliplatin) chemotherapy regimens']","['antiemetic efficacy', 'vomiting and no nausea', 'incidence and severity of nausea and vomiting', 'CR rate', 'adverse events', 'nausea and vomiting', 'incidence of adverse events', 'complete response (CR) rate, defined as the proportion of patients without emesis episodes or rescue medication use during the overall phase of the first cycle', 'Nausea and Vomiting']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0023882', 'cui_str': 'Spastic diplegia'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}]","[{'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0423584', 'cui_str': 'No nausea'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",248.0,0.429539,"The incidence of adverse events was similar between the 2 groups (100 [80.0%] vs 96 [81.3%]; P = .79), and no grade 3 or 4 aprepitant treatment-related adverse events were observed.","[{'ForeName': 'De-Shen', 'Initials': 'DS', 'LastName': 'Wang', 'Affiliation': ""State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Ming-Tao', 'Initials': 'MT', 'LastName': 'Hu', 'Affiliation': ""State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Zhi-Qiang', 'Initials': 'ZQ', 'LastName': 'Wang', 'Affiliation': ""State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Ren', 'Affiliation': ""State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Miao-Zhen', 'Initials': 'MZ', 'LastName': 'Qiu', 'Affiliation': ""State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Hui-Yan', 'Initials': 'HY', 'LastName': 'Luo', 'Affiliation': ""State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': ""State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'William Pat', 'Initials': 'WP', 'LastName': 'Fong', 'Affiliation': ""State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Shu-Bin', 'Initials': 'SB', 'LastName': 'Wang', 'Affiliation': ""Department of Oncology, Peking University Shenzhen Hospital, Shenzhen, People's Republic of China.""}, {'ForeName': 'Jie-Wen', 'Initials': 'JW', 'LastName': 'Peng', 'Affiliation': ""Chemotherapy Department, Zhongshan People's Hospital, Zhongshan, Guangdong Province, People's Republic of China.""}, {'ForeName': 'Qing-Feng', 'Initials': 'QF', 'LastName': 'Zou', 'Affiliation': ""Section 3 of Internal Medicine, Cancer Center of Guangzhou Medical University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Tan', 'Affiliation': ""State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Feng-Hua', 'Initials': 'FH', 'LastName': 'Wang', 'Affiliation': ""State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yu-Hong', 'Initials': 'YH', 'LastName': 'Li', 'Affiliation': ""State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Sun Yat-sen University, Guangzhou, People's Republic of China.""}]",JAMA network open,['10.1001/jamanetworkopen.2021.5250'] 3249,33835143,"Commentary on: A Randomized, Single-Blind, Crossover Study Evaluating the Impact of OnabotulinumtoxinA Treatment on Mood and Appearance During the COVID-19 Pandemic.",,2021,,[],['OnabotulinumtoxinA'],[],[],"[{'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}]",[],,0.0735599,,"[{'ForeName': 'Viren', 'Initials': 'V', 'LastName': 'Patel', 'Affiliation': 'Center for Human Appearance, Division of Plastic Surgery, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Sarwer', 'Affiliation': 'Social and Behavioral Sciences, and Director of the Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA.'}, {'ForeName': 'Scott P', 'Initials': 'SP', 'LastName': 'Bartlett', 'Affiliation': 'Center for Human Appearance, Division of Plastic Surgery, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.'}]",Aesthetic surgery journal,['10.1093/asj/sjab180'] 3250,33835104,Editor's Spotlight/Take 5: Do Relaxation Exercises Decrease Pain After Arthroscopic Rotator Cuff Repair? A Randomized Controlled Trial.,,2021,,"[""Editor's Spotlight/Take 5""]",['Relaxation Exercises'],['Pain'],[],"[{'cui': 'C0203993', 'cui_str': 'Relaxation exercise'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.235856,,"[{'ForeName': 'Seth S', 'Initials': 'SS', 'LastName': 'Leopold', 'Affiliation': 'S. S. Leopold, Editor-in-Chief, Clinical Orthopaedics and Related Research®, Philadelphia, PA, USA.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001759'] 3251,33835051,Clinical effects of ursodeoxycholic acid on patients with ulcerative colitis may improve via the regulation of IL-23-IL-17 axis and the changes of the proportion of intestinal microflora.,"Background We aimed to evaluate the therapeutic effect of additional ursodeoxycholic acid (UDCA) with mesalazine, compared to mesalazine alone in patients with ulcerative colitis (UC). The mechanism was evaluated by monitoring the changes of IL-23-IL-17 axis and the intestinal microflora. Methods In this prospective, single center study, patients with UC were randomly assigned to the Mesalazine group (n=20) or the UDCA + Mesalazine group (n=20). Mayo score and Inflammatory Bowel Disease Questionnaire (IBDQ), and fecal samples for 16S rRNA sequencing and blood samples for IL-23 and IL-17 ELISA were collected for analysis. Results Mayo scores and IBDQ score of the UDCA + Mesalazine group were significantly better than those of the Mesalazine group (P = 0.015 and P < 0.001, respectively). At post-treatment week 4, IL-23 and IL-17 levels were significantly lower in the UDCA + Mesalazine group compared to those in the Mesalazine group (both P < 0.038). In patients with UC after treatment, Firmicutes in the UDCA + Mesalazine group was higher than those in the Mesalazine group (P < 0.001). The UDCA + Mesalazine group showed lower percentage of Proteobacteria compared to those in the Mesalazine group (P < 0.001). Conclusion Additional UDCA could provide better therapeutic effects than mesalazine alone, possibly due to the change of IL-23 and IL-17 and the proportional distribution of intestinal microflora.",2021,"At post-treatment week 4, IL-23 and IL-17 levels were significantly lower in the UDCA + Mesalazine group compared to those in the Mesalazine group (both P < 0.038).","['patients with ulcerative colitis (UC', 'patients with UC', 'patients with ulcerative colitis']","['ursodeoxycholic acid (UDCA', 'UDCA', 'mesalazine', 'Mesalazine', 'UDCA + Mesalazine', 'ursodeoxycholic acid']","['percentage of Proteobacteria', 'Mayo score and Inflammatory Bowel Disease Questionnaire (IBDQ), and fecal samples for 16S rRNA sequencing and blood samples for IL-23 and IL-17 ELISA', 'Results\n\n\nMayo scores and IBDQ score', 'IL-23 and IL-17 levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}]","[{'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}, {'cui': 'C0127615', 'cui_str': 'mesalamine'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0751985', 'cui_str': 'Proteobacteria'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0035702', 'cui_str': '16S Ribosomal RNA'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0963088', 'cui_str': 'IL-23'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0533333,"At post-treatment week 4, IL-23 and IL-17 levels were significantly lower in the UDCA + Mesalazine group compared to those in the Mesalazine group (both P < 0.038).","[{'ForeName': 'Zhengjun', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Department of Gastroenterology, The 900th Hospital of Joint Logistic Support Force, PLA, Fujian Medical University Fuzong Clinical College, Fuzhou, China.'}, {'ForeName': 'Jinhua', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Care, Union Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology, Department of Gastroenterology, The 900th Hospital of Joint Logistic Support Force, PLA, Fujian Medical University Fuzong Clinical College, Fuzhou, China.'}, {'ForeName': 'Longke', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'Department of Gastroenterology, Department of Gastroenterology, The 900th Hospital of Joint Logistic Support Force, PLA, Fujian Medical University Fuzong Clinical College, Fuzhou, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Department of Gastroenterology, The 900th Hospital of Joint Logistic Support Force, PLA, Fujian Medical University Fuzong Clinical College, Fuzhou, China.'}]",Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association,['10.4103/sjg.SJG_462_20'] 3252,33835038,Uncovering the Bone-Muscle Interaction and Its Implications for the Health and Function of Older Adults (the Wellderly Project): Protocol for a Randomized Controlled Crossover Trial.,"BACKGROUND Bone and muscle are closely linked anatomically, biochemically, and metabolically. Acute exercise affects both bone and muscle, implying a crosstalk between the two systems. However, how these two systems communicate is still largely unknown. We will explore the role of undercarboxylated osteocalcin (ucOC) in this crosstalk. ucOC is involved in glucose metabolism and has a potential role in muscle maintenance and metabolism. OBJECTIVE The proposed trial will determine if circulating ucOC levels in older adults at baseline and following acute exercise are associated with parameters of muscle function and if the ucOC response to exercise varies between older adults with low muscle quality and those with normal or high muscle quality. METHODS A total of 54 men and women aged 60 years or older with no history of diabetes and warfarin and vitamin K use will be recruited. Screening tests will be performed, including those for functional, anthropometric, and clinical presentation. On the basis of muscle quality, a combined equation of lean mass (leg appendicular skeletal muscle mass in kg) and strength (leg press; one-repetition maximum), participants will be stratified into a high or low muscle function group and randomized into the controlled crossover acute intervention. Three visits will be performed approximately 7 days apart, and acute aerobic exercise, acute resistance exercise, and a control session (rest) will be completed in any order. Our primary outcome for this study is the effect of acute exercise on ucOC in older adults with low muscle function and those with high muscle function. RESULTS The trial is active and ongoing. Recruitment began in February 2018, and 38 participants have completed the study as of May 26, 2019. CONCLUSIONS This study will provide novel insights into bone and muscle crosstalk in older adults, potentially identifying new clinical biomarkers and mechanistic targets for drug treatments for sarcopenia and other related musculoskeletal conditions. TRIAL REGISTRATION Australia New Zealand Clinical Trials Registry ACTRN12618001756213; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375925. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/18777.",2021,"On the basis of muscle quality, a combined equation of lean mass (leg appendicular skeletal muscle mass in kg) and strength (leg press; one-repetition maximum), participants will be stratified into a high or low muscle function group and randomized into the controlled crossover acute intervention.","['older adults with low muscle quality and those with normal or high muscle quality', '54 men and women aged 60 years or older with no history of diabetes and warfarin and vitamin K use will be recruited', 'older adults', 'older adults with low muscle function and those with high muscle function', 'Recruitment began in February 2018, and 38 participants have completed the study as of May 26, 2019', 'Older Adults']","['undercarboxylated osteocalcin (ucOC', 'acute exercise']",[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0042878', 'cui_str': 'Vitamin K'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}]",[],54.0,0.178214,"On the basis of muscle quality, a combined equation of lean mass (leg appendicular skeletal muscle mass in kg) and strength (leg press; one-repetition maximum), participants will be stratified into a high or low muscle function group and randomized into the controlled crossover acute intervention.","[{'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Smith', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, VIC, Australia.'}, {'ForeName': 'Xuzhu', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, VIC, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Scott', 'Affiliation': 'Australian Institute for Musculoskeletal Science, University of Melbourne and Western Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Tara C', 'Initials': 'TC', 'LastName': 'Brennan-Speranza', 'Affiliation': 'School of Medical Sciences and School of Public Health, Faculty of Medicine and Health, University of Sydney, New South Wales, Australia.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Al Saedi', 'Affiliation': 'Australian Institute for Musculoskeletal Science, University of Melbourne and Western Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Moreno-Asso', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, VIC, Australia.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Woessner', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, VIC, Australia.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Bani Hassan', 'Affiliation': 'Australian Institute for Musculoskeletal Science, University of Melbourne and Western Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Eynon', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, VIC, Australia.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Duque', 'Affiliation': 'Australian Institute for Musculoskeletal Science, University of Melbourne and Western Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Itamar', 'Initials': 'I', 'LastName': 'Levinger', 'Affiliation': 'Australian Institute for Musculoskeletal Science, University of Melbourne and Western Health, Melbourne, VIC, Australia.'}]",JMIR research protocols,['10.2196/18777'] 3253,33835033,Social Network Analysis of the Effects of a Social Media-Based Weight Loss Intervention Targeting Adults of Low Socioeconomic Status: Single-Arm Intervention Trial.,"BACKGROUND Obesity is a known risk factor for cardiovascular disease risk factors, including hypertension and type II diabetes. Although numerous weight loss interventions have demonstrated efficacy, there is considerably less evidence about the theoretical mechanisms through which they work. Delivering lifestyle behavior change interventions via social media provides unique opportunities for understanding mechanisms of intervention effects. Server data collected directly from web-based platforms can provide detailed, real-time behavioral information over the course of intervention programs that can be used to understand how interventions work. OBJECTIVE The objective of this study was to demonstrate how social network analysis can facilitate our understanding of the mechanisms underlying a social media-based weight loss intervention. METHODS We performed secondary analysis by using data from a pilot study that delivered a dietary and physical activity intervention to a group of participants via Facebook. We mapped out participants' interaction networks over the 12-week intervention period and linked participants' network characteristics (eg, in-degree, out-degree, network constraint) to participants' changes in theoretical mediators (ie, dietary knowledge, perceived social support, self-efficacy) and weight loss by using regression analysis. We also performed mediation analyses to explore how the effects of social network measures on weight loss could be mediated by the aforementioned theoretical mediators. RESULTS In this analysis, 47 participants from 2 waves completed the study and were included. We found that increases in the number of posts, comments, and reactions significantly predicted weight loss (β=-.94, P=.04); receiving comments positively predicted changes in self-efficacy (β=7.81, P=.009), and the degree to which one's network neighbors are tightly connected with each other weakly predicted changes in perceived social support (β=7.70, P=.08). In addition, change in self-efficacy mediated the relationship between receiving comments and weight loss (β=-.89, P=.02). CONCLUSIONS Our analyses using data from this pilot study linked participants' network characteristics with changes in several important study outcomes of interest such as self-efficacy, social support, and weight. Our results point to the potential of using social network analysis to understand the social processes and mechanisms through which web-based behavioral interventions affect participants' psychological and behavioral outcomes. Future studies are warranted to validate our results and to further explore the relationship between network dynamics and study outcomes in similar and larger trials.",2021,"We found that increases in the number of posts, comments, and reactions significantly predicted weight loss (β=-.94, P=.04); receiving comments positively predicted changes in self-efficacy (β=7.81, P=.009), and the degree to which one's network neighbors are tightly connected with each other weakly predicted changes in perceived social support (β=7.70, P=.08).","['Adults of Low Socioeconomic Status', '47 participants from 2 waves completed the study and were included']","['dietary and physical activity intervention', 'Social Media-Based Weight Loss Intervention']","['weight loss', 'self-efficacy', 'theoretical mediators (ie, dietary knowledge, perceived social support, self-efficacy) and weight loss']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}]",47.0,0.0265985,"We found that increases in the number of posts, comments, and reactions significantly predicted weight loss (β=-.94, P=.04); receiving comments positively predicted changes in self-efficacy (β=7.81, P=.009), and the degree to which one's network neighbors are tightly connected with each other weakly predicted changes in perceived social support (β=7.70, P=.08).","[{'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'Department of Allied Health Sciences, College of Agriculture, Health and Natural Resources, University of Connecticut, Storrs, CT, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cavallo', 'Affiliation': 'Department of Nutrition, School of Medicine, Case Western Reserve University, Cleveland, OH, United States.'}]",Journal of medical Internet research,['10.2196/24690'] 3254,33834976,[Application effect of respiratory stepwise management in patients with septic shock combined with acute lung injury].,"OBJECTIVE To observe the application effect of respiratory stepwise management in patients with septic shock combined with acute lung injury (ALI). METHODS 100 patients with septic shock combined with ALI were selected as the research objects in Haikou Hospital Affiliated to Xiangya Medical College of Central South University from January 2018 to June 2020. Fifty patients were given endotracheal intubation or invasive ventilation on the basis of conventional treatment (conventional treatment group). According to the respiratory situation and blood gas, 50 patients were given systematic respiratory support step-by-step treatment according to the principle of simple to complex, and appropriate and scientific respiratory support was given according to the sequence from unarmed to mechanical (respiratory stepwise management group). The differences of cardiac index (CI), central venous pressure (CVP), mean arterial pressure (MAP), extravascular lung water index (EVLWI), arterial partial pressure of carbon dioxide (PaCO 2 ), arterial partial pressure of oxygen (PaO 2 ), oxygenation index (PaO 2 /FiO 2 ) before and after treatment were compared between the two groups, the therapeutic effects of the two groups were evaluated, and the resuscitation effect, postoperative complications rate, tracheotomy rate, utilization rate of invasive ventilator of the two groups were recorded. RESULTS After treatment, CI, CVP, EVLWI, PaO 2 , PaO 2 /FiO 2 levels of the two groups were significantly higher than before treatment, MAP and PaCO 2 levels were significantly lower than before treatment; MAP and PaCO 2 levels after treatment of the respiratory stepwise management group were significantly lower than those of the conventional treatment group [MAP (mmHg, 1 mmHg = 0.133 kPa): 68.2±7.0 vs. 74.4±6.8, PaCO 2 (mmHg): 37.82±4.05 vs. 41.76±4.59], the levels of EVLWI, PaO 2 and PaO 2 /FiO 2 in the respiratory stepwise management group were significantly higher than those in the conventional treatment group [EVLWI (mL/kg): 15.34±3.03 vs. 13.64±3.32, PaO 2 (mmHg): 84.44±4.83 vs. 79.03±5.54, PaO 2 /FiO 2 (mmHg): 452.42±51.32 vs. 431.73±50.03, all P < 0.05]. There was no significant difference in CI or CVP after treatment between respiratory stepwise management group and conventional treatment group [CI (mL×s -1 ×m -2 ): 70.01±21.67 vs. 66.68±18.34, CVP (mmHg): 11.1±3.2 vs. 12.3±3.2, both P > 0.05]. Compared with the conventional treatment group, the average recovery time of the respiratory stepwise management group was earlier (hours: 2.04±0.54 vs. 4.29±0.20, P < 0.05), the stable breathing time was shorter (hours: 3.07±0.22 vs. 5.36±0.35, P < 0.05), the total effective rate and the success rate of recovery were significantly improved [86.0% (43/50) vs. 60.0% (30/50), 94.0% (47/50) vs. 74.0% (37/50), both P < 0.05], the incidence of ventilator associated pneumonia (VAP) and airway complications were significantly reduced [14.0% (7/50) vs. 32.0% (16/50), 12.0% (6/50) vs. 40.0% (20/50), both P < 0.05], and the tracheotomy rate and the utilization rate of invasive ventilator were significantly reduced [8.0% (4/50) vs. 28.0% (14/50), 30.0% (15/50) vs. 60.0% (30/50), both P < 0.05]. CONCLUSIONS Respiratory stepwise management can effectively improve the resuscitation effect of septic shock patients with ALI, improve cardiopulmonary function, blood gas index and the treatment efficiency, effectively reduce the incidence of iatrogenic trauma and complications.",2021,"There was no significant difference in CI or CVP after treatment between respiratory stepwise management group and conventional treatment group [CI (mL×s -1 ×m -2 ): 70.01±21.67 vs. 66.68±18.34, CVP (mmHg):","['patients with septic shock combined with acute lung injury (ALI', 'Fifty patients were given', '100 patients with septic shock combined with ALI were selected as the research objects in Haikou Hospital Affiliated to Xiangya Medical College of Central South University from January 2018 to June 2020', 'patients with septic shock combined with acute lung injury']","['systematic respiratory support step-by-step treatment according to the principle of simple to complex, and appropriate and scientific respiratory support was given according to the sequence from unarmed to mechanical (respiratory stepwise management group', 'endotracheal intubation or invasive ventilation', 'respiratory stepwise management']","['average recovery time', 'total effective rate and the success rate of recovery', 'CI, CVP, EVLWI, PaO 2 , PaO 2 /FiO 2 levels', 'incidence of ventilator associated pneumonia (VAP) and airway complications', 'resuscitation effect, postoperative complications rate, tracheotomy rate, utilization rate of invasive ventilator', 'tracheotomy rate and the utilization rate of invasive ventilator', 'CI or CVP', 'cardiopulmonary function, blood gas index', 'MAP and PaCO 2 levels', 'levels of EVLWI, PaO 2 and PaO 2 /FiO 2', 'cardiac index (CI), central venous pressure (CVP), mean arterial pressure (MAP), extravascular lung water index (EVLWI), arterial partial pressure of carbon dioxide (PaCO 2 ), arterial partial pressure of oxygen (PaO 2 ), oxygenation index (PaO 2 /FiO 2 ', 'stable breathing time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0242488', 'cui_str': 'Acute lung injury'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index'}, {'cui': 'C0199666', 'cui_str': 'Measurement of central venous pressure'}, {'cui': 'C0015380', 'cui_str': 'Lung Water, Extravascular'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0428190', 'cui_str': 'Measurement of arterial partial pressure of carbon dioxide'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",50.0,0.0350242,"There was no significant difference in CI or CVP after treatment between respiratory stepwise management group and conventional treatment group [CI (mL×s -1 ×m -2 ): 70.01±21.67 vs. 66.68±18.34, CVP (mmHg):","[{'ForeName': 'Yudan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Haikou Hospital Affiliated to Xiangya Medical College of Central South University, Haikou 570208, Hainan, China. Corresponding author: Wu Yudan, Email: wdn19888@163.com.'}, {'ForeName': 'Meilan', 'Initials': 'M', 'LastName': 'Liang', 'Affiliation': ''}, {'ForeName': 'Meijing', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Qionge', 'Initials': 'Q', 'LastName': 'Fu', 'Affiliation': ''}, {'ForeName': 'Cimei', 'Initials': 'C', 'LastName': 'Zeng', 'Affiliation': ''}]",Zhonghua wei zhong bing ji jiu yi xue,['10.3760/cma.j.cn121430-20201019-00678'] 3255,33834913,Evaluation of the Modified Atkins Diet for the Treatment of Epileptic Spasms Refractory to Hormonal Therapy: A Randomized Controlled Trial.,"OBJECTIVES We aimed to evaluate the efficacy of the modified Atkins diet in children with epileptic spasms who had failed hormonal therapy. METHODS Children aged 9 months to 3 years having daily epileptic spasms despite a trial of ACTH or oral prednisolone and 1 additional anticonvulsant medication were enrolled. Children were randomly assigned to receive the modified Atkins diet either immediately or after a delay of 4 weeks. The ongoing anticonvulsant medications were continued unchanged. The primary outcome variable was the proportion of children who achieved spasm freedom as per parental reports at 4 weeks. Secondary outcomes included time to spasm cessation, proportion of children with electroclinical remission, the proportion of children with >50% reduction of spasms at 4 weeks, and adverse effects of the diet. (ClinicalTrials.gov Identifier: NCT03807141). RESULTS A total of 91 children were enrolled in the study; 46 in the diet group and 45 in the control group. At the end of 4 weeks, 11 children in the diet group were spasm free compared with none in the control group ( P ≤ .001). The median time to achieve spasm cessation was 10 days (interquartile range 9-20). Nine of these had resolution of hypsarrhythmia on electroencephalography (EEG). Thirty (65.2%) in the diet group had >50% reduction in spasms, compared with none in the control group ( P < .001). The most common side effect was constipation, noted in 34.8% of the children. CONCLUSIONS The modified Atkins diet was found to be effective and well tolerated in children with epileptic spasms refractory to hormonal therapy.",2021,"had >50% reduction in spasms, compared with none in the control group ( P < .001).","['Children aged 9 months to 3 years having daily epileptic spasms despite a trial of', 'children with epileptic spasms refractory to hormonal therapy', 'children with epileptic spasms who had failed hormonal therapy', 'and 1 additional anticonvulsant medication were enrolled', 'Epileptic Spasms Refractory to Hormonal Therapy', '91 children were enrolled in the study; 46 in the diet group and 45 in the control group']","['ACTH or oral prednisolone', 'modified Atkins diet', 'Modified Atkins Diet']","['effective and well tolerated', 'spasms', 'proportion of children who achieved spasm freedom', 'median time to achieve spasm cessation', 'spasm free', 'resolution of hypsarrhythmia on electroencephalography (EEG', 'time to spasm cessation, proportion of children with electroclinical remission, the proportion of children with >50% reduction of spasms at 4 weeks, and adverse effects of the diet']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1527366', 'cui_str': 'Salaam Seizures'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0003286', 'cui_str': 'Anticonvulsant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0358513', 'cui_str': 'Prednisolone-containing product in oral dose form'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0026821', 'cui_str': 'Cramp'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]",91.0,0.133798,"had >50% reduction in spasms, compared with none in the control group ( P < .001).","[{'ForeName': 'Suvasini', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': ""Department of Pediatrics, Division of Pediatric Neurology, 28856Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital, New Delhi, India.""}, {'ForeName': 'Shaiphali', 'Initials': 'S', 'LastName': 'Goel', 'Affiliation': ""Department of Pediatrics, Division of Pediatric Neurology, 28856Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital, New Delhi, India.""}, {'ForeName': 'Dipti', 'Initials': 'D', 'LastName': 'Kapoor', 'Affiliation': ""Department of Pediatrics, Division of Pediatric Neurology, 28856Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital, New Delhi, India.""}, {'ForeName': 'Divyani', 'Initials': 'D', 'LastName': 'Garg', 'Affiliation': 'Department of Neurology, 28856Lady Hardinge Medical College and Associated Smt. Sucheta Kriplani Hospital, New Delhi, India.'}, {'ForeName': 'Isha', 'Initials': 'I', 'LastName': 'Panda', 'Affiliation': ""Department of Pediatrics, Division of Pediatric Neurology, 28856Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital, New Delhi, India.""}, {'ForeName': 'Aman', 'Initials': 'A', 'LastName': 'Elwadhi', 'Affiliation': ""Department of Pediatrics, Division of Pediatric Neurology, 28856Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital, New Delhi, India.""}, {'ForeName': 'Bijoy', 'Initials': 'B', 'LastName': 'Patra', 'Affiliation': ""Department of Pediatrics, 28856Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital, New Delhi, India.""}, {'ForeName': 'Sharmila B', 'Initials': 'SB', 'LastName': 'Mukherjee', 'Affiliation': ""Department of Pediatrics, 28856Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital, New Delhi, India.""}, {'ForeName': 'Harish', 'Initials': 'H', 'LastName': 'Pemde', 'Affiliation': ""Department of Pediatrics, 28856Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital, New Delhi, India.""}]",Journal of child neurology,['10.1177/08830738211004747'] 3256,33834892,Building Community in the HIV Online Intervention Space: Lessons From the HealthMPowerment Intervention.,"BACKGROUND Mobile health platforms can facilitate social support and address HIV (human immunodeficiency virus) stigma but pose challenges for intervention design and participant engagement. Giddens's structuration theory, that individuals are shaped by-and shape-their communities through rules and resources that give them power to operate within these environments, provides a useful analytic framework for exploring these dynamic intervention spaces. METHOD Data were drawn from an online randomized controlled trial intervention (HealthMpowerment) for young Black men who have sex with men to reduce condomless anal intercourse. We applied a conversational analysis informed by structuration theory to 65 user-generated conversations that included stigma content. We aimed to understand how the interdependent relationship between the intervention space and participants' contributions might contribute to behavior change. RESULTS Thirty five intervention participants contributed to the analyzed conversations. Our analysis identified three types of conversational processes that may underlie behavior change: (1) Through intervention engagement, participants established norms and expectations that shaped their discussions; (2) participants used anecdotes and anonymity to reinforce norms; and (3) intervention staff members sought to improve engagement and build knowledge by initiating discussions and correcting misinformation, thus playing an integral role in the online community. CONCLUSIONS The lens of structuration theory usefully reveals potential behavior change mechanisms within the social interactions of an online intervention. Future design of these interventions to address HIV stigma should explicitly characterize the context in which individuals (study staff and participants) engage with one another in order to assess whether these processes are associated with improved intervention outcomes.",2021,"BACKGROUND Mobile health platforms can facilitate social support and address HIV (human immunodeficiency virus) stigma but pose challenges for intervention design and participant engagement.","['Building Community in the HIV Online Intervention Space', 'young Black men who have sex with men to reduce condomless anal intercourse']",['intervention (HealthMpowerment'],[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0556628', 'cui_str': 'Anal penetration'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],2.0,0.071257,"BACKGROUND Mobile health platforms can facilitate social support and address HIV (human immunodeficiency virus) stigma but pose challenges for intervention design and participant engagement.","[{'ForeName': 'Natalie A', 'Initials': 'NA', 'LastName': 'Blackburn', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Willa', 'Initials': 'W', 'LastName': 'Dong', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Threats', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Barry', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'LeGrand', 'Affiliation': 'Duke Global Health Institute, Durham, NC, USA.'}, {'ForeName': 'Lisa B', 'Initials': 'LB', 'LastName': 'Hightow-Weidman', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Soni', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Deren V', 'Initials': 'DV', 'LastName': 'Pulley', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Bauermeister', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Muessig', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/10901981211003859'] 3257,33834887,Threaded Intramedullary Nails Are Biomechanically Superior to Crossed K-wires for Metacarpal Neck Fractures.,"BACKGROUND Intramedullary nail (IMN) fixation of metacarpal fractures is an alternative to Kirschner wire (K-wire) fixation. The goal of this study was to compare the biomechanical properties of K-wire fixation with a threaded IMN (InNate; ExsoMed, Aliso Viejo, California). METHODS The study design was based on previously described biomechanical models for evaluating metacarpal fractures. Sixteen fresh frozen small finger-matched and ring finger-matched pairs were randomized to either IMN or 0.045 in K-wire fixation after receiving a standardized neck osteotomy. Proper implant placement was confirmed with plain radiographs. Specimens then underwent loading in a 3-point bend configuration. Load to failure (LTF), stiffness, and fracture displacement were recorded. Mechanical failure was defined by a sharp change in the load-displacement curve. RESULTS Age, sex, sidedness (left or right), and digit (ring or small finger) were evenly distributed between groups. The IMN had a significantly higher LTF than K-wires (546 N vs 154 N, P < .001). The K-wire fixation demonstrated plastic deformation between 75 and 150 N. Intramedullary nail stiffness was higher than that of K-wires (155.89 N/mm vs 59.28 N/mm, P < .001). CONCLUSIONS When surgical fixation is indicated for metacarpal neck and shaft fractures, the threaded IMN is biomechanically superior to crossed K-wires with the application of 3-point bend.",2021,"The K-wire fixation demonstrated plastic deformation between 75 and 150 N. Intramedullary nail stiffness was higher than that of K-wires (155.89 N/mm vs 59.28 N/mm, P < .001). ",['Sixteen fresh frozen small finger-matched and ring finger-matched pairs'],"['IMN or 0.045\u2009in K-wire fixation after receiving a standardized neck osteotomy', 'Kirschner wire (K-wire) fixation', 'K-wire fixation with a threaded IMN', 'Intramedullary nail (IMN) fixation']","['Intramedullary nail stiffness', 'Mechanical failure', 'Load to failure (LTF), stiffness, and fracture displacement', 'plastic deformation']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0575827', 'cui_str': 'Small finger'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}]","[{'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C4517410', 'cui_str': '0.045'}, {'cui': 'C0086510', 'cui_str': 'K-wire'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}]","[{'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0585059', 'cui_str': 'Fracture with displacement'}, {'cui': 'C0032167', 'cui_str': 'Plastic'}]",16.0,0.0603328,"The K-wire fixation demonstrated plastic deformation between 75 and 150 N. Intramedullary nail stiffness was higher than that of K-wires (155.89 N/mm vs 59.28 N/mm, P < .001). ","[{'ForeName': 'Midhat', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'The University of Arizona College of Medicine - Phoenix, USA.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Castañeda', 'Affiliation': 'The University of Arizona College of Medicine - Phoenix, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Campbell', 'Affiliation': 'The University of Arizona College of Medicine - Phoenix, USA.'}, {'ForeName': 'Jill G', 'Initials': 'JG', 'LastName': 'Putnam', 'Affiliation': 'The University of Arizona College of Medicine - Phoenix, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'McKee', 'Affiliation': 'The University of Arizona College of Medicine - Phoenix, USA.'}]","Hand (New York, N.Y.)",['10.1177/15589447211003182'] 3258,33833300,The effect of cellphone position on driving and gaze behaviour.,"Legislation frequently restricts the use of cellphones while driving. Despite this, many people continue to interact with cellphones covertly while driving, typically by concealing their device in their lap. This strategy leads to frequent diversion of the drivers' gaze from the road ahead, potentially reducing their driving performance. To evaluate the influence of cellphone use on driving, 30 participants took part in three randomly ordered 7-min virtual reality driving simulations. In each condition, drivers were presented with either (a) no cellphone, (b) a cellphone fixed to the windscreen, or (c) a cellphone positioned at lap level. Their task was to maintain road position and observe speed limits while answering maths problems (delivered intermittently via 'text message') and searching for external target objects. Outcome measures included speed, lane position standard deviation (LPSD), and fixation behaviour, which were compared between trials. In trials where a cellphone was present, participants shifted fixation more frequently, drove approximately 6 km/h faster, exhibited a lower LPSD and spent more time in the correct lane on the road (compared to the no-cellphone condition; all p < 0.001). Cellphone position influenced eye gaze behaviour, with drivers looking at the cellphone less frequently, and the speedometer more frequently. when the cellphone was in their lap compared to when the cellphone was positioned on the windscreen. Our results are consistent with participants driving more cautiously-checking speed and lane position more frequently-when they have a cellphone in the lap. Real-world driving data would be useful to determine whether this change in driving behaviour we observed is sufficient to offset the increased risk introduced by spending less time looking at the road ahead.",2021,"Cellphone position influenced eye gaze behaviour, with drivers looking at the cellphone less frequently, and the speedometer more frequently.",['30 participants took part in three randomly ordered 7-min virtual reality driving simulations'],"['cellphone', 'cellphone position']","['eye gaze behaviour', 'driving and gaze behaviour', 'speed, lane position standard deviation (LPSD), and fixation behaviour']","[{'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C1136359', 'cui_str': 'Cellular Phone'}, {'cui': 'C0733755', 'cui_str': 'Position'}]","[{'cui': 'C4505383', 'cui_str': 'Eye Gaze'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]",30.0,0.054308,"Cellphone position influenced eye gaze behaviour, with drivers looking at the cellphone less frequently, and the speedometer more frequently.","[{'ForeName': 'Philip R K', 'Initials': 'PRK', 'LastName': 'Turnbull', 'Affiliation': 'University of Auckland, 85 Park Rd., Grafton, Auckland, 1023, New Zealand. p.turnbull@auckland.ac.nz.'}, {'ForeName': 'Safal', 'Initials': 'S', 'LastName': 'Khanal', 'Affiliation': 'University of Alabama at Birmingham, 1716 University Blvd., Birmingham, AL, 35233, USA.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Dakin', 'Affiliation': 'University of Auckland, 85 Park Rd., Grafton, Auckland, 1023, New Zealand.'}]",Scientific reports,['10.1038/s41598-021-87120-2'] 3259,33833278,"Impact of acute partial-body cryostimulation on cognitive performance, cerebral oxygenation, and cardiac autonomic activity.","We assessed the effects of a 3-min partial-body cryostimulation (PBC) exposure-where the whole body is exposed to extreme cold, except the head-on cognitive inhibition performance and the possible implications of parasympathetic cardiac control and cerebral oxygenation. In a randomized controlled counterbalanced cross-over design, eighteen healthy young adults (nine males and nine females) completed a cognitive Stroop task before and after one single session of PBC (3-min exposure at - 150 °C cold air) and a control condition (3 min at room temperature, 20 °C). During the cognitive task, heart rate variability (HRV) and cerebral oxygenation of the prefrontal cortex were measured using heart rate monitoring and near-infrared spectroscopy methods. We also recorded the cerebral oxygenation during the PBC session. Stroop performance after PBC exposure was enhanced (562.0 ± 40.2 ms) compared to pre-PBC (602.0 ± 56.4 ms; P < 0.042) in males only, accompanied by an increase (P < 0.05) in HRV indices of parasympathetic tone, in greater proportion in males compared to females. During PBC, cerebral oxygenation decreased in a similar proportion in males and females but the cerebral extraction (deoxyhemoglobin: ΔHHb) remained higher after exposure in males, only. These data demonstrate that a single PBC session enhances the cognitive inhibition performance on a Stroop task in males, partly mediated by a greater parasympathetic cardiac control and greater cerebral oxygenation. The effects of PBC on cognitive function seem different in females, possibly explained by a different sensitivity to cold stimulation.",2021,"Stroop performance after PBC exposure was enhanced (562.0 ± 40.2 ms) compared to pre-PBC (602.0 ± 56.4 ms; P < 0.042) in males only, accompanied by an increase (P < 0.05) in HRV indices of parasympathetic tone, in greater proportion in males compared to females.",['eighteen healthy young adults (nine males and nine females'],"['PBC', 'cognitive Stroop task before and after one single session of PBC (3-min exposure at -\u2009150\xa0°C cold air) and a control condition', '3-min partial-body cryostimulation (PBC) exposure']","['HRV indices of parasympathetic tone', 'Stroop performance after PBC exposure', 'cerebral oxygenation', 'cognitive task, heart rate variability (HRV) and cerebral oxygenation of the prefrontal cortex', 'cognitive inhibition performance', 'cognitive performance, cerebral oxygenation, and cardiac autonomic activity', 'cognitive function']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0450029', 'cui_str': 'Cold air'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",18.0,0.0211537,"Stroop performance after PBC exposure was enhanced (562.0 ± 40.2 ms) compared to pre-PBC (602.0 ± 56.4 ms; P < 0.042) in males only, accompanied by an increase (P < 0.05) in HRV indices of parasympathetic tone, in greater proportion in males compared to females.","[{'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Theurot', 'Affiliation': 'Laboratory MOVE (EA 6314), Faculty of Sport Sciences, University of Poitiers, 8 allée Jean Monnet, 86000, Poitiers, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Dugué', 'Affiliation': 'Laboratory MOVE (EA 6314), Faculty of Sport Sciences, University of Poitiers, 8 allée Jean Monnet, 86000, Poitiers, France.'}, {'ForeName': 'Wafa', 'Initials': 'W', 'LastName': 'Douzi', 'Affiliation': 'Laboratory MOVE (EA 6314), Faculty of Sport Sciences, University of Poitiers, 8 allée Jean Monnet, 86000, Poitiers, France.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Guitet', 'Affiliation': 'Laboratory MOVE (EA 6314), Faculty of Sport Sciences, University of Poitiers, 8 allée Jean Monnet, 86000, Poitiers, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Louis', 'Affiliation': 'Research Institute for Sport and Exercise Sciences (RISES), Liverpool John Moores University, Byrom Street, Liverpool, L3 3AF, UK.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Dupuy', 'Affiliation': 'Laboratory MOVE (EA 6314), Faculty of Sport Sciences, University of Poitiers, 8 allée Jean Monnet, 86000, Poitiers, France. olivier.dupuy@univ-poitiers.fr.'}]",Scientific reports,['10.1038/s41598-021-87089-y'] 3260,33832544,"Echinacea reduces antibiotic usage in children through respiratory tract infection prevention: a randomized, blinded, controlled clinical trial.","BACKGROUND In children, up to 30% of viral respiratory tract infections (RTIs) develop into bacterial complications associated with pneumonia, sinusitis or otitis media to trigger a tremendous need for antibiotics. This study investigated the efficacy of Echinacea for the prevention of viral RTIs, for the prevention of secondary bacterial complications and for reducing rates of antibiotic prescriptions in children. METHODS Echinaforce® Junior tablets [400 mg freshly harvested Echinacea purpurea alcoholic extract] or vitamin C [50 mg] as control were given three times daily for prevention to children 4-12 years. Two × 2 months of prevention were separated by a 1-week treatment break. Parents assessed respiratory symptoms in children via e-diaries and collected nasopharyngeal secretions for screening of respiratory pathogens (Allplex® RT-PCR). RESULTS Overall, 429 cold days occurred in N ITT  = 103 children with Echinacea in comparison to 602 days in N ITT  = 98 children with vitamin C (p < 0.001, Chi-square test). Echinacea prevented 32.5% of RTI episodes resulting in an odds ratio of OR = 0.52 [95% CI 0.30-0.91, p = 0.021]. Six children (5.8%) with Echinacea and 15 children (15.3%) with vitamin C required 6 and 24 courses of antibiotic treatment, respectively (reduction of 76.3%, p < 0.001). A total of 45 and 216 days of antibiotic therapy were reported in the two groups, respectively (reduction of 80.2% (p < 0.001). Eleven and 30 events of RTI complications (e.g., otitis media, sinusitis or pneumonia) occurred with Echinacea and vitamin C, respectively (p = 0.0030). Echinacea significantly prevented influenza (3 vs. 20 detections, p = 0.012) and enveloped virus infections (29 vs. 47 detections, p = 0.0038). Finally, 76 adverse events occurred with Echinacea and 105 events with vitamin C (p = 0.016), only three events were reported possibly related with Echinacea. CONCLUSIONS Our results support the use of Echinacea for the prevention of RTIs and reduction of associated antibiotic usage in children. Trial registration clinicaltrials.gov, NCT02971384, 23th Nov 2016.",2021,"Echinacea significantly prevented influenza (3 vs. 20 detections, p = 0.012) and enveloped virus infections (29 vs. 47 detections, p = 0.0038).","['children', 'children through respiratory tract infection prevention', 'Echinaforce® Junior tablets']","['vitamin C', 'Echinacea']","['RTI complications (e.g., otitis media, sinusitis or pneumonia', 'respiratory symptoms', 'enveloped virus infections']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C3712557', 'cui_str': 'Echinaforce'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0752270', 'cui_str': 'Echinacea Preparation'}]","[{'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0029882', 'cui_str': 'Otitis media'}, {'cui': 'C0037199', 'cui_str': 'Sinusitis'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}]",103.0,0.263984,"Echinacea significantly prevented influenza (3 vs. 20 detections, p = 0.012) and enveloped virus infections (29 vs. 47 detections, p = 0.0038).","[{'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Ogal', 'Affiliation': 'Pediatric Clinic, Brunnen, Switzerland.'}, {'ForeName': 'Sebastian L', 'Initials': 'SL', 'LastName': 'Johnston', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Klein', 'Affiliation': 'd.s.h. Statistical Services GmbH, Rohrbach, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Schoop', 'Affiliation': 'A Vogel AG, Grünaustrasse 4, 9325, Roggwil, TG, Switzerland. r.schoop@avogel.ch.'}]",European journal of medical research,['10.1186/s40001-021-00499-6'] 3261,33832531,Gap balancing improve squat function and knee function: a randomized controlled trial comparing gap balancing and measured resection.,"OBJECTIVE We compared the measured resection (MR) technique and the gap balancing (GB) technique in patients with knee osteoarthritis after primary total knee arthroplasty (TKA) in China to understand the effects of the two techniques on knee function and squat function. METHODS From March 2017 to September 2019, a prospective randomized controlled trial was conducted with 96 patients with knee osteoarthritis undergoing primary TKA from March 2017 to September 2019 randomized to GB group (n = 48) and MR group (n = 48). Intraoperative indicators (operation time, osteotomy volume of medial and lateral of posterior femoral condyles, external rotation angle) were recorded during operation. At 1, 3, 6, and 12 months after surgery, all the patients came to the hospital for review and underwent the pain severity, Western Ontario and McMaster University Osteoarthritis Index (WOMAC), knee joint range of motion, Oxford Knee Score (OKS), and American Knee Society Score (AKSS) tests. All patients were followed up for more than 1 year. RESULTS The osteotomy volume of the medial femoral condyle in the GB group was higher than that in the MR group (P<0.05), and the operation time in the GB group was shorter than that in the MR group (P<0.05). At 1, 3, 6, and 12 months after surgery, the pain severity in the GB group was lower than that in the MR group (P<0.05), the knee range of motion in the GB group was larger than that in the MR group (P<0.05), the WOMAC of the GB group was lower than that of the MR group (P<0.05), the OKS of the GB group was higher than that of the MR group (P<0.05), the AKSS of the GB group was higher than that of the MR group. The incidence of postoperative complications in the GB group (4.17%) was significantly lower than that in the MR group (18.75%) (P<0.05). CONCLUSION The GB technique can effectively shorten the operation time, relieve pain, improve knee range of motion, improve squat function and knee function, reduce osteoarthritis index, and reduce the occurrence of complications, which is worthy of clinical popularization and application.",2021,"The osteotomy volume of the medial femoral condyle in the GB group was higher than that in the MR group (P<0.05), and the operation time in the GB group was shorter than that in the MR group (P<0.05).","['patients with knee osteoarthritis after primary total knee arthroplasty (TKA) in China', '96 patients with knee osteoarthritis undergoing primary TKA from March 2017 to September 2019 randomized to GB group (n = 48) and MR group (n = 48', 'From March 2017 to September 2019']","['Gap balancing', 'measured resection (MR) technique and the gap balancing (GB) technique']","['osteotomy volume of the medial femoral condyle', 'squat function and knee function', 'knee range of motion', 'operation time, relieve pain, improve knee range of motion, improve squat function and knee function, reduce osteoarthritis index', 'OKS', 'WOMAC', 'operation time', 'Intraoperative indicators (operation time, osteotomy volume of medial and lateral of posterior femoral condyles, external rotation angle', 'pain severity, Western Ontario and McMaster University Osteoarthritis Index (WOMAC), knee joint range of motion, Oxford Knee Score (OKS), and American Knee Society Score (AKSS) tests', 'pain severity', 'incidence of postoperative complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0448196', 'cui_str': 'Structure of medial condyle of femur'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0576094', 'cui_str': 'Knee joint - range of movement'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0582800', 'cui_str': 'Condyle of femur'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",96.0,0.0411611,"The osteotomy volume of the medial femoral condyle in the GB group was higher than that in the MR group (P<0.05), and the operation time in the GB group was shorter than that in the MR group (P<0.05).","[{'ForeName': 'Qingfang', 'Initials': 'Q', 'LastName': 'Xiao', 'Affiliation': 'Department of Osteoarthrosis, Renmin Hospital, Hubei University of Medicine, No.39 Middle Chaoyang Road, Maojian District, Shiyan, Hubei, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Department of Osteoarthrosis, Renmin Hospital, Hubei University of Medicine, No.39 Middle Chaoyang Road, Maojian District, Shiyan, Hubei, China.'}, {'ForeName': 'Binghao', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': 'Department of Osteoarthrosis, Renmin Hospital, Hubei University of Medicine, No.39 Middle Chaoyang Road, Maojian District, Shiyan, Hubei, China. hubeizhaobinghao@163.com.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-021-02367-9'] 3262,32337834,Test-retest reliability of six-minute walk tests over a one-year period in patients with chronic heart failure.,"PURPOSE The aims of this study were to determine the test-retest reliability of the duplicated six-minute walk test (6MWT) in patients with chronic heart failure (HF), and to evaluate its variation over time. METHODS Forty-six patients (9 women) with HF performed duplicated 6MWT every third month for 1 year (5 follow-ups), for a total of 198 paired tests. The patients completed two 6MWT on the same day with a 45-min seated rest between tests. RESULTS The mean distance in metres, for the first (6MWT1) versus the second (6MWT2), for each follow-up, was 408 ± 100 versus 411 ± 96, 449 ± 94 versus 465 ± 94, 464 ± 96 versus 473 ± 100, 462 ± 103 versus 468 ± 104 and 472 ± 105 versus 482 ± 107. On average, a marginally, clinically insignificant longer walked distance, 9 m (2.0%), was seen in the second 6MWT. The standard error of a single determination (S method ) ranged from 2.4% to 3.9% over the study period, and the intraclass correlation coefficient (ICC) ranged from 0.96 to 0.99 (CI 95% 0.94-0.99). The variation over time of ICC or S method was not statistically significant. CONCLUSION The 6MWT is highly reliable over time in patients with HF, and one test is, therefore, sufficient in clinical follow-ups.",2020,"On average, a marginally, clinically insignificant longer walked distance, 9 m (2.0%), was seen in the second 6MWT.","['Forty-six patients (9 women) with', '100 versus 411\xa0±\xa096, 449\xa0±\xa094 versus 465\xa0±\xa094, 464\xa0±\xa096 versus 473\xa0±\xa0100, 462\xa0±\xa0103 versus 468\xa0±\xa0104 and 472\xa0±\xa0105 versus 482\xa0±\xa0107', 'patients with chronic heart failure (HF', 'patients with chronic heart failure']","['HF performed duplicated 6MWT', 'duplicated six-minute walk test (6MWT', '6MWT']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}]",[],,0.0316778,"On average, a marginally, clinically insignificant longer walked distance, 9 m (2.0%), was seen in the second 6MWT.","[{'ForeName': 'Charlotta', 'Initials': 'C', 'LastName': 'Lans', 'Affiliation': 'Department of Physiotherapy, Region Kalmar County, Kalmar, Sweden.'}, {'ForeName': 'Åsa', 'Initials': 'Å', 'LastName': 'Cider', 'Affiliation': 'Institute of Neuroscience and Physiology/Physiotherapy, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Nylander', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Brudin', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.'}]",Clinical physiology and functional imaging,['10.1111/cpf.12637'] 3263,32488583,Parent Perceptions of Caregiver-Mediated Telemedicine Tools for Assessing Autism Risk in Toddlers.,"Telemedicine tools have potential for increasing access to diagnostic services for children with autism spectrum disorder (ASD). Past work has utilized tele-assessment procedures in which remote psychologists observe administration of interactive screening instruments by trained, on-site providers. Although promising, this approach relies on two clinicians, limiting its efficiency and scalability. The present study examined the use, acceptability, and parents' perceptions of two caregiver-mediated tools for assessing ASD risk in toddlers, in which remote clinicians guided parents to complete interactive screening activities with their children. Most parents found tele-assessment to be comfortable, and many reported liking the parent-led nature of these tools. Parents also offered constructive feedback, which was used to modify the tele-assessment process for future study.",2021,"Most parents found tele-assessment to be comfortable, and many reported liking the parent-led nature of these tools.","['children with autism spectrum disorder (ASD', 'Toddlers']",['Telemedicine'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}]",[],2.0,0.0368375,"Most parents found tele-assessment to be comfortable, and many reported liking the parent-led nature of these tools.","[{'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Corona', 'Affiliation': 'Vanderbilt Kennedy Center/Treatment and Research Institute for Autism Spectrum Disorders, Vanderbilt University Medical Center, Nashville, TN, USA. Laura.L.Corona@vumc.org.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Weitlauf', 'Affiliation': 'Vanderbilt Kennedy Center/Treatment and Research Institute for Autism Spectrum Disorders, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Hine', 'Affiliation': 'Vanderbilt Kennedy Center/Treatment and Research Institute for Autism Spectrum Disorders, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Berman', 'Affiliation': 'Vanderbilt Kennedy Center/Treatment and Research Institute for Autism Spectrum Disorders, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Miceli', 'Affiliation': 'Vanderbilt Kennedy Center/Treatment and Research Institute for Autism Spectrum Disorders, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Nicholson', 'Affiliation': 'Vanderbilt Kennedy Center/Treatment and Research Institute for Autism Spectrum Disorders, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Stone', 'Affiliation': 'Vanderbilt Kennedy Center/Treatment and Research Institute for Autism Spectrum Disorders, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Neill', 'Initials': 'N', 'LastName': 'Broderick', 'Affiliation': 'Vanderbilt Kennedy Center/Treatment and Research Institute for Autism Spectrum Disorders, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Francis', 'Affiliation': 'Vanderbilt Kennedy Center/Treatment and Research Institute for Autism Spectrum Disorders, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'A Pablo', 'Initials': 'AP', 'LastName': 'Juárez', 'Affiliation': 'Vanderbilt Kennedy Center/Treatment and Research Institute for Autism Spectrum Disorders, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Vehorn', 'Affiliation': 'Vanderbilt Kennedy Center/Treatment and Research Institute for Autism Spectrum Disorders, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Wagner', 'Affiliation': 'Vanderbilt Kennedy Center/Treatment and Research Institute for Autism Spectrum Disorders, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Warren', 'Affiliation': 'Vanderbilt Kennedy Center/Treatment and Research Institute for Autism Spectrum Disorders, Vanderbilt University Medical Center, Nashville, TN, USA.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04554-9'] 3264,32170358,"Surgeon-defined assessment is a poor predictor of knee balance in total knee arthroplasty: a prospective, multicenter study.","BACKGROUND The accuracy of surgeon-defined assessment (SDA) of soft tissue balance in total knee arthroplasty (TKA) is poorly understood despite balance being considered a significant determinant of surgical success. The study's hypothesis was that intra-operative SDA is a poor predictor of coronal balance in TKA. METHODS A prospective, multicenter study assessing accuracy of SDA of balance was conducted in 250 patients (285 TKAs). Eight surgeons and thirteen trainees participated, and all were blinded to sensor measurements. The primary outcome was test accuracy of SDA measured at 10°, 45° and 90° compared to sensor measures as the gold standard test. Cohen's kappa coefficient was calculated to determine chance-corrected agreement. Secondary outcomes include the relationship of SDA to level of surgical experience, analysis of between-surgeon differences, and the influence of patient and operative factors on SDA accuracy. RESULTS Average accuracy of SDA was 58.3%, 61.2% and 66.5% at 10°, 45° and 90° respectively. Cohen's kappa coefficient was 0.18 at all angles and rated as ""slight agreement"". SDA sensitivities to correctly identify a balanced knee (76.2% at 10°; 82.6% at 45°; 83.2% at 90°) were approximately twice specificities to correctly identify an unbalanced knee (42.6% at 10°; 34.1% at 45°; 41.4% at 90°). Surgical experience (surgeon versus trainee) had no effect on capacity to determine balance. Considerable between-surgeon variability was found (33-65% at 10°, 41-73% at 45°, 55-89% at 90°). CONCLUSION SDA was a poor predictor of balance, particularly when assessing the unbalanced TKA. Surgeon experience had no effect on test accuracy and considerable between-surgeon variability was recorded. These findings question the accuracy of SDA in TKA. TRIAL REGISTRATION NUMBER ACTRN# 12618000817246.",2021,"Considerable between-surgeon variability was found (33-65% at 10°, 41-73% at 45°, 55-89% at 90°). ","['total knee arthroplasty', '250 patients (285 TKAs', 'Eight surgeons and thirteen trainees participated', 'total knee arthroplasty (TKA']",['SDA'],"['unbalanced knee', 'SDA sensitivities', 'test accuracy of SDA', 'relationship of SDA to level of surgical experience, analysis of between-surgeon differences, and the influence of patient and operative factors on SDA accuracy', ""Cohen's kappa coefficient""]","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C3715149', 'cui_str': '13'}]","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439099', 'cui_str': 'Kappa'}]",,0.108323,"Considerable between-surgeon variability was found (33-65% at 10°, 41-73% at 45°, 55-89% at 90°). ","[{'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'MacDessi', 'Affiliation': 'Sydney Knee Specialists, Suite 201, Level 2, 131 Princes Hway, Kogarah, NSW, 2217, Australia. samuelmacdessi@sydneyknee.com.au.'}, {'ForeName': 'Jil A', 'Initials': 'JA', 'LastName': 'Wood', 'Affiliation': 'Sydney Knee Specialists, Suite 201, Level 2, 131 Princes Hway, Kogarah, NSW, 2217, Australia.'}, {'ForeName': 'Ashish D', 'Initials': 'AD', 'LastName': 'Diwan', 'Affiliation': 'St George and Sutherland Clinical School, University of NSW, Kogarah, NSW, Australia.'}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Harris', 'Affiliation': 'Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, Liverpool, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-020-05925-6'] 3265,32604921,Vibrational Spectroscopy of Peritoneal Dialysis Effluent for Rapid Assessment of Patient Characteristics.,"Peritoneal dialysis (PD) offers specific advantages over hemodialysis, enabling increased autonomy of patients with end-stage renal disease, but PD-related complications need to be detected in a timely manner. Fourier transform infrared (FTIR) spectroscopy could provide rapid and essential insights into the patients' risk profiles via molecular fingerprinting of PD effluent, an abundant waste material that is rich in biological information. In this study, we measured FTIR spectroscopic profiles in PD effluent from patients taking part in a randomized controlled trial of alanyl-glutamine addition to the PD-fluid. Principal component analysis of FTIR spectra enabled us to differentiate between effluent samples from patients immediately after completion of instillation of the PD-fluid into the patients' cavity and 4 h later as well as between patients receiving PD-fluid supplemented with 8 mM alanyl-glutamine compared with control. Moreover, feasibility of FTIR spectroscopy coupled to supervised classification algorithms to predict patient-, PD-, as well as immune-associated parameters were investigated. PD modality (manual continuous ambulatory PD (CAPD) vs. cycler-assisted automated PD (APD)), residual urine output, ultrafiltration, transport parameters, and cytokine concentrations showed high predictive potential. This study provides proof-of-principle that molecular signatures determined by FTIR spectroscopy of PD effluent, combined with machine learning, are suitable for cost-effective, high-throughput diagnostic purposes in PD.",2020,"Peritoneal dialysis (PD) offers specific advantages over hemodialysis, enabling increased autonomy of patients with end-stage renal disease, but PD-related complications need to be detected in a timely manner.",[],"['Peritoneal dialysis (PD', 'PD modality (manual continuous ambulatory PD (CAPD) vs. cycler-assisted automated PD (APD', 'FTIR spectroscopy', 'alanyl-glutamine', 'Fourier transform infrared (FTIR) spectroscopy']",['FTIR spectroscopic profiles'],[],"[{'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0031140', 'cui_str': 'Continuous ambulatory peritoneal dialysis'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C1997821', 'cui_str': 'Automated peritoneal dialysis'}, {'cui': 'C0043603', 'cui_str': 'pamidronate'}, {'cui': 'C0282183', 'cui_str': 'Fourier Transform'}, {'cui': 'C0260249', 'cui_str': 'Infrared spectroscopy'}, {'cui': 'C0051080', 'cui_str': 'alanylglutamine'}, {'cui': 'C1532326', 'cui_str': 'Infra-red'}, {'cui': 'C0037812', 'cui_str': 'Analysis, Spectrum'}]","[{'cui': 'C0282183', 'cui_str': 'Fourier Transform'}, {'cui': 'C1532326', 'cui_str': 'Infra-red'}]",,0.161875,"Peritoneal dialysis (PD) offers specific advantages over hemodialysis, enabling increased autonomy of patients with end-stage renal disease, but PD-related complications need to be detected in a timely manner.","[{'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Grunert', 'Affiliation': 'Functional Microbiology, Institute of Microbiology, Department of Pathobiology, University of Veterinary Medicine, Veterinaerplatz 1, 1210 Vienna, Austria.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Herzog', 'Affiliation': 'Christian Doppler Laboratory for Molecular Stress Research in Peritoneal Dialysis, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Florian M', 'Initials': 'FM', 'LastName': 'Wiesenhofer', 'Affiliation': 'Christian Doppler Laboratory for Molecular Stress Research in Peritoneal Dialysis, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Vychytil', 'Affiliation': 'Division of Nephrology and Dialysis, Department of Medicine III, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Ehling-Schulz', 'Affiliation': 'Functional Microbiology, Institute of Microbiology, Department of Pathobiology, University of Veterinary Medicine, Veterinaerplatz 1, 1210 Vienna, Austria.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Kratochwill', 'Affiliation': 'Christian Doppler Laboratory for Molecular Stress Research in Peritoneal Dialysis, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, 1090 Vienna, Austria.'}]",Biomolecules,['10.3390/biom10060965'] 3266,32091602,Assessing the Current Generation of Tourniquets.,"INTRODUCTION Tourniquet application is an urgent life-saving procedure. Previous studies demonstrated several drawbacks in tourniquet design and application methods that limit their efficacy; among them, loose application of the device before windlass twisting is a main pitfall. A new generation of modern combat tourniquets was developed to overcome these pitfalls. The objective of this study was to assess the effectiveness of three new tourniquet designs: the CAT Generation 7 (CAT7), the SAM Extremity Tourniquet (SAM-XT), and the SOF Tactical Tourniquet Wide (SOFTT-W) as well as its correlation to the degree of slack. MATERIALS AND METHODS The three tourniquet models were applied in a randomized sequence on a HapMed leg tourniquet trainer, simulating an above-the-knee traumatic amputation by 60 military medicine track cadets. Applied pressure, hemorrhage control status, time until the bleeding stopped, estimated blood volume loss, and slack were measured. RESULTS The mean (±SD) pressure applied using the SAM-XT (186 mmHg ±63) or the CAT7 (175 mmHg ±79) was significantly higher compared to the pressure applied by the SOFTT-W (104 mmHg ±101, P < 0.017), with no significant difference between the first two (P > 0.05). Hemorrhage control rate was similar (P > 0.05) with SAM-XT (73.3%) and CAT7 (67.7%), and both were significantly better than the SOFTT-W (35%, P < 0.017). Slack was similar between CAT7 and SAM-XT (5.2 mm ± 3.4 vs. 5 mm ± 3.5, P > 0.05), yet significantly lower compared to the SOFTT-W (9 mm ± 5, P < 0.017). A strong negative correlation was found between slack and hemorrhage control rate (3.2 mm ± 1.5 mm in success vs. 10.5 mm ± 3.4 mm in failure, P < 0.001) and applied pressure (Pearson's correlation coefficient of -0.83, P < 0.001). CONCLUSIONS Both SAM-XT and CAT7 demonstrated a better pressure profile and hemorrhage control rate compared to SOFTT-W, with no significant difference between the two. The better outcome measures were strongly correlated to less slack.",2020,"CONCLUSIONS Both SAM-XT and CAT7 demonstrated a better pressure profile and hemorrhage control rate compared to SOFTT-W, with no significant difference between the two.",[],"['HapMed leg tourniquet trainer, simulating an above-the-knee traumatic amputation by 60 military medicine track cadets']","['Applied pressure, hemorrhage control status, time until the bleeding stopped, estimated blood volume loss, and slack', 'slack and hemorrhage control rate', 'Hemorrhage control rate', 'pressure profile and hemorrhage control rate', 'mean (±SD) pressure applied using the SAM-XT']",[],"[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0002694', 'cui_str': 'Traumatic amputation'}, {'cui': 'C0026124', 'cui_str': 'Military medicine'}, {'cui': 'C0040594', 'cui_str': 'Track'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0149533', 'cui_str': 'Control of hemorrhage'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0005850', 'cui_str': 'Blood volume'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0036002', 'cui_str': 'S-Adenosylmethionine'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}]",,0.0650078,"CONCLUSIONS Both SAM-XT and CAT7 demonstrated a better pressure profile and hemorrhage control rate compared to SOFTT-W, with no significant difference between the two.","[{'ForeName': 'Shimon', 'Initials': 'S', 'LastName': 'Katsnelson', 'Affiliation': 'Faculty of Medicine, Institute for Research in Military Medicine, The Hebrew University of Jerusalem and Israel Defense Forces Medical Corps, POB 12272, Jerusalem 91120, Israel.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'Oppenheimer', 'Affiliation': 'Faculty of Medicine, Institute for Research in Military Medicine, The Hebrew University of Jerusalem and Israel Defense Forces Medical Corps, POB 12272, Jerusalem 91120, Israel.'}, {'ForeName': 'Rafi', 'Initials': 'R', 'LastName': 'Gerrasi', 'Affiliation': 'Biomedical Engineering Branch, Headquarters of the Surgeon General, Headquarters of the Surgeon General, Military POB 02149 Tel Hashomer, Ramat Gan, Israel, Military Postal Code 01215.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Furer', 'Affiliation': 'Medical innovation Branch, Headquarters of the Surgeon General, Israel Defense Forces Medical Corps, Ramat Gan, Israel.'}, {'ForeName': 'Linn', 'Initials': 'L', 'LastName': 'Wagnert-Avraham', 'Affiliation': 'Faculty of Medicine, Institute for Research in Military Medicine, The Hebrew University of Jerusalem and Israel Defense Forces Medical Corps, POB 12272, Jerusalem 91120, Israel.'}, {'ForeName': 'Arik', 'Initials': 'A', 'LastName': 'Eisenkraft', 'Affiliation': 'Faculty of Medicine, Institute for Research in Military Medicine, The Hebrew University of Jerusalem and Israel Defense Forces Medical Corps, POB 12272, Jerusalem 91120, Israel.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Nachman', 'Affiliation': 'Faculty of Medicine, Institute for Research in Military Medicine, The Hebrew University of Jerusalem and Israel Defense Forces Medical Corps, POB 12272, Jerusalem 91120, Israel.'}]",Military medicine,['10.1093/milmed/usz392'] 3267,33832878,Clinical trial evaluating efficacy and safety of pemetrexed based chemotherapy regimen versus ramucirumab plus erlotinib in Chinese patients with lung cancer: A preliminary investigation.,"To carry out a preliminary clinical trial to compare the effectiveness and safety of pemetrexed based chemotherapy regimen in combination of cisplatin versus ramucirumab plus erlotinib in Chinese patients with metastatic non-small-cell lung cancer (NSCLC). Patients with confirmed diagnosis of NSCLC were randomly (1:1 ratio) grouped and treated intravenously with a mixture of pemetrexed (500 mg/m 2 ) and cisplatin (75 mg/m2) plus Best Supportive Care (BSC), or ramucirumab (8 mg/kg) intravenously (IV) + erlotinib 25 mg/day. Overall survival (OS), overall response rate (ORR), progression free survival (PFS), and the safety were assessed. Pemetrexed based chemotherapy regimen in combination of cisplatin showed significantly higher OS (14.4 months vs. 10.47 months, p<0.05) and PFS (9.5 months vs. 5.1 months) than ramucirumab plus erlotinib. Objective response was also favorable in the patients treated with pemetrexed based chemotherapy regimen, when compared with those given ramucirumab plus erlotinib. Pemetrexed based chemotherapy regimen found more effective to ramucirumab plus erlotinib in improving OS, PFS and ORR, and it offers greater clinical benefits than ramucirumab plus erlotinib in Chinese NSCLC patients. Pemetrexed based chemotherapy regimen in combination of cisplatin appears to be better choice of drug for the treatment of Chinese patients with advanced stage of lung cancer.",2020,"Pemetrexed based chemotherapy regimen in combination of cisplatin showed significantly higher OS (14.4 months vs. 10.47 months, p<0.05) and PFS (9.5 months vs. 5.1 months) than ramucirumab plus erlotinib.","['Chinese patients with metastatic non-small-cell lung cancer (NSCLC', 'Chinese NSCLC patients', 'Chinese patients with lung cancer', 'Patients with confirmed diagnosis of NSCLC', 'Chinese patients with advanced stage of lung cancer']","['cisplatin (75 mg/m2) plus Best Supportive Care (BSC), or ramucirumab (8 mg/kg) intravenously (IV) + erlotinib', 'cisplatin', 'ramucirumab plus erlotinib', 'Pemetrexed', 'cisplatin versus ramucirumab plus erlotinib', 'mixture of pemetrexed', 'pemetrexed based chemotherapy regimen versus ramucirumab plus erlotinib', 'pemetrexed based chemotherapy']","['higher OS', 'PFS', 'Overall survival (OS), overall response rate (ORR), progression free survival (PFS), and the safety', 'Objective response']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",,0.0695982,"Pemetrexed based chemotherapy regimen in combination of cisplatin showed significantly higher OS (14.4 months vs. 10.47 months, p<0.05) and PFS (9.5 months vs. 5.1 months) than ramucirumab plus erlotinib.","[{'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Mei', 'Affiliation': ""Department of Medical Oncology, The First People's Hospital of Wenling, Wenling, Zhejiang, China.""}, {'ForeName': 'Lingjun', 'Initials': 'L', 'LastName': 'Ye', 'Affiliation': ""Department of Medical Oncology, The First People's Hospital of Wenling, Wenling, Zhejiang, China.""}, {'ForeName': 'Chunyou', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': ""Department of Neurology, The First People's Hospital of Wenling, Wenling, Zhejiang, China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': ""Department of Medical Oncology, The First People's Hospital of Wenling, Wenling, Zhejiang, China.""}]",Pakistan journal of pharmaceutical sciences,[] 3268,33832816,Syndesmosis fixation in supination-external rotation ankle fractures. Long-Term results of a prospective randomised study.,"BACKROUND The clinical relevance and treatment of syndesmosis injury in supination-external rotation (SER) ankle fractures are controversial. METHODS After malleolar fixation 24 SER 4 ankle fracture patients with unstable syndesmosis in external rotation stress test were randomised to syndesmosis transfixation with a screw (13 patients) or no fixation (11 patients). Mean follow-up time was 9.7 years (range, 8.9-11.0). The primary outcome measure was the Olerud-Molander Ankle Outcome Score (OMAS). Secondary outcome measures included ankle mortise congruity and degenerative osteoarthritis, 100-mm visual analogue scale for function and pain, RAND 36-Item Health Survey, and range of motion. RESULTS Mean OMAS in the syndesmosis transfixation group was 87.3 (SD 15.5) and in the no-syndesmosis-fixation group 89.0 (SD 16.0) (difference between means 1.8, 95% CI -10.4-14.0, P = 0.76). There were no differences between the two groups in secondary outcome measures. CONCLUSION With the numbers available, SER 4 ankle fractures with unstable syndesmosis can be treated with malleolar fixation only, with good to excellent long-term functional outcome.",2021,"There were no differences between the two groups in secondary outcome measures. ","['After malleolar fixation 24 SER 4 ankle fracture patients with unstable syndesmosis in external rotation stress test', 'supination-external rotation ankle fractures']","['syndesmosis transfixation with a screw (13 patients) or no fixation', 'Syndesmosis fixation']","['Olerud-Molander Ankle Outcome Score (OMAS', 'ankle mortise congruity and degenerative osteoarthritis, 100-mm visual analogue scale for function and pain, RAND 36-Item Health Survey, and range of motion', 'Mean OMAS']","[{'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0038845', 'cui_str': 'Supination'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0159877', 'cui_str': 'Fracture of ankle'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443343', 'cui_str': 'Unstable status'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449834', 'cui_str': 'Congruity'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.119403,"There were no differences between the two groups in secondary outcome measures. ","[{'ForeName': 'Ristomatti', 'Initials': 'R', 'LastName': 'Lehtola', 'Affiliation': 'Department of Surgery, Division of Orthopaedic and Trauma Surgery, Oulu University Hospital, Kajaanintie 50, P.O. Box 21, FI 90029 OYS Oulu, Finland; Medical Research Center Oulu, University of Oulu, Pentti Kaiteran Katu 1, P.O. Box 8000, FI-90014 Oulu, Finland. Electronic address: ristomatti.lehtola@ppshp.fi.'}, {'ForeName': 'Hannu-Ville', 'Initials': 'HV', 'LastName': 'Leskelä', 'Affiliation': 'Department of Surgery, Division of Orthopaedic and Trauma Surgery, Oulu University Hospital, Kajaanintie 50, P.O. Box 21, FI 90029 OYS Oulu, Finland. Electronic address: hannu-ville.leskela@ppshp.fi.'}, {'ForeName': 'Tapio E', 'Initials': 'TE', 'LastName': 'Flinkkilä', 'Affiliation': 'Department of Surgery, Division of Orthopaedic and Trauma Surgery, Oulu University Hospital, Kajaanintie 50, P.O. Box 21, FI 90029 OYS Oulu, Finland. Electronic address: tapio.flinkkila@ppshp.fi.'}, {'ForeName': 'Harri J', 'Initials': 'HJ', 'LastName': 'Pakarinen', 'Affiliation': 'Department of Surgery, Division of Orthopaedic and Trauma Surgery, Oulu University Hospital, Kajaanintie 50, P.O. Box 21, FI 90029 OYS Oulu, Finland; Pohjola Sairaala, Kiilakivenkuja 1, 90250 Oulu, Finland. Electronic address: harri.pakarinen@fimnet.fi.'}, {'ForeName': 'Jaakko L', 'Initials': 'JL', 'LastName': 'Niinimäki', 'Affiliation': 'Department of Radiology, Oulu University Hospital, Kajaanintie 50, P.O. Box 21, FI 90029 OYS Oulu, Finland. Electronic address: jaakko.niinimaki@ppshp.fi.'}, {'ForeName': 'Pasi P', 'Initials': 'PP', 'LastName': 'Ohtonen', 'Affiliation': 'Division of Operative Care, Oulu University Hospital, Kajaanintie 50, P.O. Box 21, FI 90029 OYS Oulu, Finland. Electronic address: pasi.ohtonen@oulu.fi.'}, {'ForeName': 'Tero H', 'Initials': 'TH', 'LastName': 'Kortekangas', 'Affiliation': 'Department of Surgery, Division of Orthopaedic and Trauma Surgery, Oulu University Hospital, Kajaanintie 50, P.O. Box 21, FI 90029 OYS Oulu, Finland. Electronic address: tero.kortekangas@ppshp.fi.'}]",Foot and ankle surgery : official journal of the European Society of Foot and Ankle Surgeons,['10.1016/j.fas.2021.03.014'] 3269,33832806,A Randomized Double-Blind Controlled Trial to Assess the Efficacy of Ultrasound-Guided Erector Spinae Plane Block in Cardiac Surgery.,"OBJECTIVE Cardiac surgical pain is of moderate-to-severe intensity. Ineffective pain control may lead to increased cardiopulmonary complications and poor surgical outcomes. This study aimed to assess the efficacy of ultrasound-guided erector spinae plane block in providing analgesia in adult cardiac surgeries. DESIGN Prospective, randomized, double-blinded clinical trial. SETTINGS Single-center, tertiary care hospital with university affiliation. PARTICIPANTS Thirty patients of either sex, aged 18-to-60 years, body mass index 19-to-30 kg/m 2 , undergoing elective on-pump single-vessel coronary artery bypass grafting or valve replacement under general anesthesia. INTERVENTIONS Patients were randomly categorized into two groups of 15 patients each to receive bilateral erector spinae plane block with 20 mL per side of 0.25% levobupivacaine (group E) or sham block with 20 mL of normal saline (group C). MAIN RESULTS Mean analgesic requirement in terms of fentanyl equivalents (µg) in the first 24 hours postoperatively was 225 ± 112 in group E and 635 ± 145 in group C (95% confidence interval, 313.10-506.90; p < 0.05). Mean time to first rescue analgesia was 356.9 ± 34.5 in group E and 123.9 ± 13.1 minutes in group C (p < 0.05). Cox proportional hazard ratio for rescue analgesic requirement in group E-to-group C was 5.0. Duration of mechanical ventilation was 88.4 ± 17 and 103.5 ± 18 minutes in groups E and C, respectively (p < 0.05). Ramsay sedation score at six hours postextubation was 1.45 ± 0.53 in group E and 3.19 ± 0.62 in group C (p < 0.05). Mean numerical rating score was 3.67 ± 1.41 in group E and 4.50 ± 1.00 in group C (p = 0.17). No significant differences were observed in the incidences of postoperative nausea vomiting, pruritus, and erector spinae plane block-related infection and pneumothorax. CONCLUSION Single-shot erector spinae plane block provides superior analgesia as compared with sham block. It decreased the first 24-hour postoperative analgesic consumption by 64.5% and risk of pain by five times in the authors' population. It also reduced the sedation and duration of mechanical ventilation in postcardiac surgery patients.",2021,"No significant differences were observed in the incidences of postoperative nausea vomiting, pruritus, and erector spinae plane block-related infection and pneumothorax. ","['Thirty patients of either sex, aged 18-to-60 years, body mass index 19-to-30 kg/m 2 , undergoing elective on-pump single-vessel coronary artery bypass grafting or valve replacement under general anesthesia', 'postcardiac surgery patients', 'Cardiac Surgery', 'Single-center, tertiary care hospital with university affiliation', 'adult cardiac surgeries']","['Ultrasound-Guided Erector Spinae Plane Block', 'sham block with 20 mL of normal saline', 'ultrasound-guided erector spinae plane block', 'bilateral erector spinae plane block with 20 mL per side of 0.25% levobupivacaine']","['24-hour postoperative analgesic consumption', 'postoperative nausea vomiting, pruritus, and erector spinae plane block-related infection and pneumothorax', 'Ramsay sedation score', 'Mean time to first rescue analgesia', 'Mean numerical rating score', 'sedation and duration of mechanical ventilation', 'Mean analgesic requirement', 'Duration of mechanical ventilation']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0010075', 'cui_str': 'Coronary Vessels'}, {'cui': 'C0189695', 'cui_str': 'Anastomosis of artery with bypass graft'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}]","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]",,0.535693,"No significant differences were observed in the incidences of postoperative nausea vomiting, pruritus, and erector spinae plane block-related infection and pneumothorax. ","[{'ForeName': 'Manazir', 'Initials': 'M', 'LastName': 'Athar', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, Uttar Pradesh, India. Electronic address: drmanazirathar@gmail.com.'}, {'ForeName': 'Sania', 'Initials': 'S', 'LastName': 'Parveen', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, Uttar Pradesh, India.'}, {'ForeName': 'Mayank', 'Initials': 'M', 'LastName': 'Yadav', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, Uttar Pradesh, India.'}, {'ForeName': 'Obaid Ahmed', 'Initials': 'OA', 'LastName': 'Siddiqui', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, Uttar Pradesh, India.'}, {'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Nasreen', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, Uttar Pradesh, India.'}, {'ForeName': 'Shahna', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, Uttar Pradesh, India.'}, {'ForeName': 'Mohd Azam', 'Initials': 'MA', 'LastName': 'Haseen', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, Uttar Pradesh, India.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2021.03.009'] 3270,33832645,Efficacy and safety of a new vaginal gel for the treatment of symptoms associated with vulvovaginal atrophy in postmenopausal women: A double-blind randomized placebo-controlled study.,"OBJECTIVE The aim of the present randomized placebo-controlled single-center study was to assess the efficacy and safety of a new vaginal gel (Meclon Idra - Alfasigma) in the treatment of vulvovaginal atrophy (VVA). The gel is composed of sea buckthorn (Hippophaë rhamnoides) oil, aloe vera, 18β-glycyrrhetic acid, hyaluronic acid and glycogen. The study assessed whether the gel can reduce VVA symptoms (vaginal dryness, itching, burning sensation) and improve sexual function in postmenopausal women over 12 weeks. STUDY DESIGN Postmenopausal women (n° = 60) reporting VVA symptoms were recruited and randomized in a 1:1 ratio to the gel or placebo. Active vaginal gel or placebo was applied for 14 days and then twice a week for 90 consecutive days. MAIN OUTCOME MEASURE The Vaginal Health Index (VHI), including vaginal pH, was used to assess changes in objective signs, whereas the self-reported Female Sexual Function Index (FSFI) was used to investigate sexual function. RESULTS Meclon Idra was effective in reducing vaginal pain, dyspareunia and vaginal pH, with the VHI showing significant improvement at day 90 (P < .0001), and in reducing each VVA symptom (vaginal dryness, vaginal itching, burning sensation) at weeks 2 and 4, and the end of the study (P < .0001). The analysis of FSFI scores showed, after the end of treatment, an improvement of sexual function in the active-treatment group, with a statistically significant increase (P < 0.001) in all domains scores and total score (P < 0.001). CONCLUSIONS The present single-center randomized clinical trial demonstrated the efficacy, tolerability and safety of 12-week treatment with a new vaginal gel in postmenopausal women with symptoms associated with VVA. Based on this trial, the gel seems to be a valid choice as a single, local agent for relieving VVA symptoms and improving sexual function, and to have good compliance. This trial is registered prospectively with the Clinical Trials Registry - India, number CTRI/2019/05/01911.",2021,"Meclon Idra was effective in reducing vaginal pain, dyspareunia and vaginal pH, with the VHI showing significant improvement at day 90 (P < .0001), and in reducing each VVA symptom (vaginal dryness, vaginal itching, burning sensation) at weeks 2 and 4, and the end of the study (P < .0001).","['postmenopausal women over 12 weeks', 'Postmenopausal women (n° = 60) reporting VVA symptoms', 'vulvovaginal atrophy (VVA', 'postmenopausal women with symptoms associated with VVA', 'symptoms associated with vulvovaginal atrophy in postmenopausal women']","['Active vaginal gel or placebo', 'new vaginal gel (Meclon Idra - Alfasigma', 'new vaginal gel', 'placebo', 'gel or placebo']","['FSFI scores', 'reducing each VVA symptom (vaginal dryness, vaginal itching, burning sensation', 'VVA symptoms (vaginal dryness, itching, burning sensation', 'sexual function', 'efficacy and safety', 'vaginal pain, dyspareunia and vaginal pH', 'efficacy, tolerability and safety', 'Vaginal Health Index (VHI), including vaginal pH, was used to assess changes in objective signs, whereas the self-reported Female Sexual Function Index (FSFI', 'Efficacy and safety']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0857741', 'cui_str': 'Vulvovaginal atrophy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0042257', 'cui_str': 'Vaginal gel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0857741', 'cui_str': 'Vulvovaginal atrophy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0241633', 'cui_str': 'Vaginal dryness'}, {'cui': 'C0042256', 'cui_str': 'Pruritus of vagina'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0236082', 'cui_str': 'Vaginal pain'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C0429263', 'cui_str': 'Vaginal pH'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",,0.102784,"Meclon Idra was effective in reducing vaginal pain, dyspareunia and vaginal pH, with the VHI showing significant improvement at day 90 (P < .0001), and in reducing each VVA symptom (vaginal dryness, vaginal itching, burning sensation) at weeks 2 and 4, and the end of the study (P < .0001).","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'De Seta', 'Affiliation': ""Institute for Maternal and Child Health, IRCCS Burlo Garofolo, via dell'Istria 65/1, 34137 Trieste, Italy; Department of Medicine, Surgery and Health Sciences, University of Trieste, Trieste, Italy. Electronic address: fradeseta@gmail.com.""}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Caruso', 'Affiliation': 'Department of General Surgery and Medical Surgical Specialties, Research Group for Sexology, University of Catania, via S.Sofia, 78 - 95123 Catania, Italy. Electronic address: scaruso@unict.it.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Di Lorenzo', 'Affiliation': ""Institute for Maternal and Child Health, IRCCS Burlo Garofolo, via dell'Istria 65/1, 34137 Trieste, Italy. Electronic address: giovanni.dilorenzo@burlo.trieste.it.""}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Romano', 'Affiliation': ""Institute for Maternal and Child Health, IRCCS Burlo Garofolo, via dell'Istria 65/1, 34137 Trieste, Italy. Electronic address: federico.romano@burlo.trieste.it.""}, {'ForeName': 'Mariateresa', 'Initials': 'M', 'LastName': 'Mirandola', 'Affiliation': 'Department of Medicine, Surgery and Health Sciences, University of Trieste, Trieste, Italy. Electronic address: tea.mirandola@gmail.com.'}, {'ForeName': 'Rossella E', 'Initials': 'RE', 'LastName': 'Nappi', 'Affiliation': 'Research Center for Reproductive Medicine, Gynecological Endocrinology and Menopause, Obstetrics and Gynecology Unit, IRCCS S. Matteo Foundation, Department of Clinical, Surgical, Diagnostic and Paediatric Sciences, University of Pavia, Viale Camillo Golgi, 19, 27100 Pavia, Italy. Electronic address: renappi@tin.it.'}]",Maturitas,['10.1016/j.maturitas.2021.03.002'] 3271,33832641,A 'case-mix' approach to understand adherence trajectories for a falls prevention exercise intervention: A longitudinal cohort study.,"OBJECTIVE We identified adherence-based case-mixes from participants' longitudinal adherence to falls prevention exercise interventions over 12 months. Second, we identified modifiable baseline predictors (cognition, mobility and functional status) based on participants' case-mix adherence trajectories. STUDY DESIGN AND OUTCOME MEASURES This study was a 12-month longitudinal secondary analysis of data from 172 participants who received the Otago Exercise Program (OEP) in a randomized controlled trial. Adherence to the OEP was ascertained monthly via self-report. Case-mixes, groups of individuals who followed similar adherence trajectories, were visually defined using 12-month longitudinal trajectories; we used latent class growth modeling. Baseline predictors of adherence were examined for the following categories: 1) cognition, 2) mobility and 3) functional status. RESULTS Four distinct case-mixes were identified. The ""non-adherent"" case-mix (18 %) was distinguished by a non-adherent and decreasing adherence trajectory over time. The ""low adherence"" case-mix (45 %) did not have complete adherence or consistent adherence over the 12-month follow-up. The ""moderate adherence"" case-mix (27 %) was characterized by a stable (i.e., non-variable) adherence trajectory with a slightly increasing pattern at midpoint. The ""high adherence"" case-mix (10 %) demonstrated consistent and high adherence over the 12-month follow-up. For individuals with ""moderate adherence"", the Digit Symbol Substitution Test (DSST) significantly predicted adherence (relative risk ratio (RRR) = 1.12 (0.95 CI: 1.0-1.26); p = 0.049). For individuals with ""high adherence"", the Digits Forward minus Digits Backward (RRR = 0.43 (0.95 CI: 0.23-0.79); p = 0.002) and Instrumental Activities of Daily Living (RRR = 0.36 (0.95 CI: 0.16-0.81); p = 0.01) significantly predicted adherence. CONCLUSIONS Cognitive profile and activities of daily living at baseline may predict the longitudinal pattern of adherence.",2021,"For individuals with ""moderate adherence"", the Digit Symbol Substitution Test (DSST) significantly predicted adherence (relative risk ratio (RRR) =",['172 participants who received the'],"['Otago Exercise Program (OEP', 'Digit Symbol Substitution Test (DSST', 'falls prevention exercise intervention']","['cognition, 2) mobility and 3) functional status', 'adherence (relative risk ratio (RRR) ', 'Instrumental Activities of Daily Living']","[{'cui': 'C4517601', 'cui_str': '172'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}]",172.0,0.140923,"For individuals with ""moderate adherence"", the Digit Symbol Substitution Test (DSST) significantly predicted adherence (relative risk ratio (RRR) =","[{'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Davis', 'Affiliation': 'Faculty of Management, University of British Columbia - Okanagan, Social and Economic Change Laboratory, Kelowna, British Columbia, Canada; Center for Hip Health and Mobility, Vancouver Coastal Health Research Institute, University of British Columbia, Vancouver, British Columbia, Canada. Electronic address: jennifer.davis@ubc.ca.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Khan', 'Affiliation': 'Center for Hip Health and Mobility, Vancouver Coastal Health Research Institute, University of British Columbia, Vancouver, British Columbia, Canada; Department of Family Practice, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada. Electronic address: https://twitter.com/@KarimKhan_IMHA.'}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Mansournia', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran; Sports Medicine Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: mansournia_m@sina.tums.ac.ir.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Khosravi', 'Affiliation': 'Department of Epidemiology, School of Public Health, Shahroud University of Medical Sciences, Shahroud, Iran. Electronic address: a.khosravi@shmu.ac.ir.'}, {'ForeName': 'Ryan E', 'Initials': 'RE', 'LastName': 'Rhodes', 'Affiliation': 'Behavioural Medicine Laboratory, School of Exercise Science, Physical and Health Education, University of Victoria, Victoria, British Columbia, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Chan', 'Affiliation': 'Center for Hip Health and Mobility, Vancouver Coastal Health Research Institute, University of British Columbia, Vancouver, British Columbia, Canada; Department of Family Practice, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada; Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran; Aging, Mobility, and Cognitive Neuroscience Lab, Department of Physical Therapy, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Department of Family Practice, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada; Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran; Aging, Mobility, and Cognitive Neuroscience Lab, Department of Physical Therapy, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Jehu', 'Affiliation': 'Center for Hip Health and Mobility, Vancouver Coastal Health Research Institute, University of British Columbia, Vancouver, British Columbia, Canada; Aging, Mobility, and Cognitive Neuroscience Lab, Department of Physical Therapy, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada; Djavad Mowafaghian Centre for Brain Health, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Naaz', 'Initials': 'N', 'LastName': 'Parmar', 'Affiliation': 'Department of Medicine, Division of Geriatric Medicine, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Liu-Ambrose', 'Affiliation': 'Center for Hip Health and Mobility, Vancouver Coastal Health Research Institute, University of British Columbia, Vancouver, British Columbia, Canada; Aging, Mobility, and Cognitive Neuroscience Lab, Department of Physical Therapy, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada; Djavad Mowafaghian Centre for Brain Health, University of British Columbia, Vancouver, British Columbia, Canada.'}]",Maturitas,['10.1016/j.maturitas.2021.02.004'] 3272,33832635,Measuring self-regulation after nutrition education modules with Self Determination Theory (SDT) intervention among teachers with or at Risk Metabolic Syndrome.,"OBJECTIVE This study aims to measure changes in autonomy in groups that have been given nutrition education by applying the SDT concept. METHODS The non-randomized pre-post intervention study design involved 63 teachers in the intervention group and 60 teachers in the control group. Nutrition education by applying the SDT concept and measurement is carried out using the Treatment Self-Regulation Questionnaire (TRSQ). RESULTS The results showed that there was a significant change in support autonomy in the intervention group (p=0.034) and not in the control group. Controlled variables and amotivation did not show significant differences in the two groups, but changes for the better occurred in the intervention group. CONCLUSION The application of the SDT concept can increase support for autonomy. This is expected to support sustainable behavior change.",2021,The results showed that there was a significant change in support autonomy in the intervention group (p=0.034) and not in the control group.,"['teachers with or at Risk Metabolic Syndrome', '63 teachers in the intervention group and 60 teachers in the control group']",['Self Determination Theory (SDT) intervention'],['support autonomy'],"[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036595', 'cui_str': 'Self Determination'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}]",63.0,0.0141213,The results showed that there was a significant change in support autonomy in the intervention group (p=0.034) and not in the control group.,"[{'ForeName': 'Ridwan Mochtar', 'Initials': 'RM', 'LastName': 'Thaha', 'Affiliation': 'Health Promotion Department, Public Health Faculty, Hasanuddin University, South Sulawesi, Indonesia.'}, {'ForeName': 'Nurzakiah', 'Initials': 'N', 'LastName': 'Hasan', 'Affiliation': 'Health College Baramuli, Pinrang, South Sulawesi, Indonesia; Nutrition Department, Public Health Faculty, Hasanuddin University, South Sulawesi, Indonesia. Electronic address: nurzakiahksruh@gmail.com.'}, {'ForeName': 'Veni', 'Initials': 'V', 'LastName': 'Hadju', 'Affiliation': 'Nutrition Department, Public Health Faculty, Hasanuddin University, South Sulawesi, Indonesia.'}, {'ForeName': 'Nurhaedar', 'Initials': 'N', 'LastName': 'Jafar', 'Affiliation': 'Nutrition Department, Public Health Faculty, Hasanuddin University, South Sulawesi, Indonesia.'}, {'ForeName': 'Syurawasti', 'Initials': 'S', 'LastName': 'Muhiddin', 'Affiliation': 'Psychology Department, Medicine Faculty, Hasanuddin University, South Sulawesi, Indonesia.'}, {'ForeName': 'Ida Leida', 'Initials': 'IL', 'LastName': 'Maria', 'Affiliation': 'Epidemiology Department, Public Health Faculty, Hasanuddin University, South Sulawesi, Indonesia.'}]",Gaceta sanitaria,['10.1016/j.gaceta.2020.12.023'] 3273,33832610,Causes and Risk Factors for Death in Diabetes: A Competing-Risk Analysis From the SAVOR-TIMI 53 Trial.,,2021,,['Diabetes'],[],[],"[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]",[],[],,0.153985,,"[{'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Cavallari', 'Affiliation': ''}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ''}, {'ForeName': 'Ph Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': ''}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ''}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': ''}, {'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': ''}, {'ForeName': 'Kyungah', 'Initials': 'K', 'LastName': 'Im', 'Affiliation': ''}, {'ForeName': 'Itamar', 'Initials': 'I', 'LastName': 'Raz', 'Affiliation': ''}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ''}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Scirica', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2021.02.030'] 3274,33832548,Youth sport participation and physical activity in rural communities.,"BACKGROUND Physical activity, a high-frequency health behavior, varies by where children live, learn, and play. Children accumulate physical activity in adult-led in-school and out-of-school settings. Youth sport is a potential setting for physical activity, but there are differences in youth sport participation based on age, sex, and socioeconomic status. There is a gap in understanding demographic influences on youth sport participation and how these factors interact to influence physical activity. This study examines influences of grade, sex, and family income on youth sport participation and these factors and youth sport participation on moderate-to-vigorous physical activity of children in rural communities. METHODS Children (n = 418 3rd-6th graders) living in two rural communities completed the online Youth Activity Profile as part of Wellscapes, a type 3 hybrid implementation-effectiveness community randomized trial. Mixed models with community as a random effect examined main effects and interactions of grade, sex, and family income on youth sport participation and these factors and youth sport participation on moderate-to-vigorous physical activity. RESULTS About 80% of children engaged in youth sport, and full-pay lunch students were almost four times more likely to have youth sport participation than students with free/reduced lunch (OR = 3.91, 95% CI = 1.95, 7.8). Females and 6th graders (p < 0.05) had lower physical activity than comparison groups. Males with higher family income had greater physical activity; females with higher family income had less physical activity. For 6th graders, high family income had less effect on physical activity than similar 3rd-5th graders (p < 0.01). CONCLUSIONS While a fairly high percentage of children participate in youth sports, there are disparities in rural communities on youth sport participation and physical activity outcomes based on age, sex, and family income.",2021,Females and 6th graders (p < 0.05) had lower physical activity than comparison groups.,"['Children (n\u2009=\u2009418 3rd-6th graders) living in two rural communities completed the online Youth Activity Profile as part of Wellscapes, a type 3 hybrid implementation-effectiveness community randomized trial', 'children in rural communities', 'Youth sport participation and physical activity in rural communities']",[],"['physical activity', 'youth sport participation', 'Children accumulate physical activity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4042873', 'cui_str': 'Adolescent Sports'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4042873', 'cui_str': 'Adolescent Sports'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",,0.0196134,Females and 6th graders (p < 0.05) had lower physical activity than comparison groups.,"[{'ForeName': 'Debra K', 'Initials': 'DK', 'LastName': 'Kellstedt', 'Affiliation': 'College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA. Deb.kellstedt@unmc.edu.'}, {'ForeName': 'Michaela A', 'Initials': 'MA', 'LastName': 'Schenkelberg', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska at Omaha, Omaha, NE, USA.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Essay', 'Affiliation': 'College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Von Seggern', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska at Omaha, Omaha, NE, USA.'}, {'ForeName': 'Richard R', 'Initials': 'RR', 'LastName': 'Rosenkranz', 'Affiliation': 'College of Health & Human Sciences, Kansas State University, Manhattan, KS, USA.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Welk', 'Affiliation': 'College of Human Sciences, Iowa State University, Ames, IA, USA.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'High', 'Affiliation': 'College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Dzewaltowski', 'Affiliation': 'College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.'}]",Archives of public health = Archives belges de sante publique,['10.1186/s13690-021-00570-y'] 3275,33832432,Reducing prescribing of benzodiazepines in older adults: a comparison of four physician-focused interventions by a medical regulatory authority.,"BACKGROUND The inappropriate and/or high prescribing of benzodiazepine and 'Z' drugs (BDZ +) is a major health concern. The purpose of this study was to determine whether physician or pharmacist led interventions or a simple letter or a personalized prescribing report from a medical regulatory authority (MRA) was the most effective intervention for reducing BDZ + prescribing by physicians to patients 65 years of age or older. METHODS This was a four-armed, one year, blinded, randomized, parallel-group, investigational trial in Alberta, Canada. Participants were fully licensed physicians (n = 272) who had prescribed 4 times the defined daily dose (4 + DDD) or more of any BDZ + to an older patient at least once in the 3 rd quarter of 2016. All physician-participants were sent a personalized prescribing profile by the MRA. They were then randomized into four groups that received either nothing more, an additional personal warning letter from the MRA, a personal phone call from an MRA pharmacist or a personal phone call from an MRA physician. The main outcomes were prescribing behavior change of physicians at one year in terms of: change in mean number of older patients receiving 4 + DDD BDZ + and mean dose BDZ + prescribed per physician. To adjust for multiple statistical testing, we used MANCOVA to test both main outcome measures simultaneously by group whilst controlling for any baseline differences. RESULTS All groups experienced a significant fall in the total number of older patients receiving 4 + DDD of BDZ + by about 50% (range 43-54%) per physician at one year, and a fall in the mean dose of BDZ + prescribed of about 13% (range 10-16%). However, there was no significant difference between each group. CONCLUSIONS A personalized prescribing report alone sent from the MRA appears to be an effective intervention for reducing very high levels of BDZ + prescribing in older patients. Additional interventions by a pharmacist or physician did not result in additional benefit. The intervention needs to be tested further on a more general population of physicians, prescribing less extreme doses of BDZ + and that looks at more clinical and healthcare utilization outcomes.",2021,"All groups experienced a significant fall in the total number of older patients receiving 4 + DDD of BDZ + by about 50% (range 43-54%) per physician at one year, and a fall in the mean dose of BDZ + prescribed of about 13% (range 10-16%).","['older adults', 'patients 65\xa0years of age or older', 'Participants were fully licensed physicians (n\u2009=\u2009272) who had prescribed 4 times the defined daily dose (4\u2009+\u2009DDD) or more of any BDZ\u2009+\u2009to an older patient at least once in the 3 rd quarter of 2016', 'older patients']","['physician or pharmacist led interventions or a simple letter or a personalized prescribing report from a medical regulatory authority (MRA', 'additional personal warning letter from the MRA, a personal phone call from an MRA pharmacist or a personal phone call from an MRA physician', 'benzodiazepines', 'benzodiazepine']","['total number', 'prescribing behavior change of physicians at one year in terms of: change in mean number of older patients receiving 4\u2009+\u2009DDD BDZ\u2009+\u2009and mean dose BDZ\u2009+\u2009prescribed per physician']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0023636', 'cui_str': 'Licenses'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0011037', 'cui_str': 'DDD'}]","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011037', 'cui_str': 'DDD'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",,0.0520589,"All groups experienced a significant fall in the total number of older patients receiving 4 + DDD of BDZ + by about 50% (range 43-54%) per physician at one year, and a fall in the mean dose of BDZ + prescribed of about 13% (range 10-16%).","[{'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Ashworth', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, Canada. ashworth@ualberta.ca.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Kain', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Delaney', 'Initials': 'D', 'LastName': 'Wiebe', 'Affiliation': 'Research and Evaluation Unit, College of Physicians and Surgeons of Alberta, 10020-100 Street NW, Edmonton, AB, 2700T5J 0N3, Canada.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Hernandez-Ceron', 'Affiliation': 'Research and Evaluation Unit, College of Physicians and Surgeons of Alberta, 10020-100 Street NW, Edmonton, AB, 2700T5J 0N3, Canada.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Jess', 'Affiliation': 'Research and Evaluation Unit, College of Physicians and Surgeons of Alberta, 10020-100 Street NW, Edmonton, AB, 2700T5J 0N3, Canada.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Mazurek', 'Affiliation': 'Research and Evaluation Unit, College of Physicians and Surgeons of Alberta, 10020-100 Street NW, Edmonton, AB, 2700T5J 0N3, Canada.'}]",BMC family practice,['10.1186/s12875-021-01415-x'] 3276,33832307,Mechanism of Huayu Jianpi Fangshi decoction in urolithiasis prevention: a randomized trial.,"BACKGROUND This study aims to explore the mechanism of the Huayu Jianpi Fangshi decoction in urolithiasis prevention. METHODS The present study was designed as a randomized, double-blinded, placebo-controlled clinical trial. Sixty patients with the qi stagnation and blood stasis, spleen deficiency, and dampness obstruction types of urolithiasis were randomly divided into two groups: the treatment group and the control group (n=30 in both groups). Patients in the treatment group were treated with the Huayu Jianpi Fangshi decoction, while patients in the control group were treated with the Huayu Fangshi placebo decoction. Both treatments were taken orally two times per day. All patients received treatment over the course of four weeks. The main outcome indicators included the Tamm-Horsfall protein (THP) expression levels, osteopontin, and inter-αtrypsin inhibitor heavy chain 3 (ITIH3) in the patients' urine as well as changes in 24-h urinary citric acid, urinary magnesium levels, and Traditional Chinese Medicine (TCM) syndrome scores. RESULTS The results of the present study revealed a significant increase in the total citric acid excretion level (244.75±59.62 vs. 297.48±57.91 mmol/L, P<0.01), significant decrease in the total urinary THP level (10.83±7.73 vs. 6.37±6.10 mg/L, P<0.05), significant decrease in the total ITIH3 level (9.51±6.32 vs. 6.14±4.46 mg/L, P<0.05) in the patients' 24-h urine, and a significant elevation of the total TCM syndrome score (5% vs. 23%, P<0.01) in the treatment group when compared with the control group. CONCLUSIONS ",2021,"The main outcome indicators included the Tamm-Horsfall protein (THP) expression levels, osteopontin, and inter-αtrypsin inhibitor heavy chain 3 (ITIH3) in the patients' urine as well as changes in 24-h urinary citric acid, urinary magnesium levels, and Traditional Chinese Medicine (TCM) syndrome scores. ","['Sixty patients with the qi stagnation and blood stasis, spleen deficiency, and dampness obstruction types of urolithiasis']","['placebo', 'Huayu Fangshi placebo decoction', 'Huayu Jianpi Fangshi decoction']","['total citric acid excretion level', 'total TCM syndrome score', 'total urinary THP level', 'total ITIH3 level', ""Tamm-Horsfall protein (THP) expression levels, osteopontin, and inter-αtrypsin inhibitor heavy chain 3 (ITIH3) in the patients' urine as well as changes in 24-h urinary citric acid, urinary magnesium levels, and Traditional Chinese Medicine (TCM) syndrome scores""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0333138', 'cui_str': 'Stasis'}, {'cui': 'C0037993', 'cui_str': 'Splenic structure'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0451641', 'cui_str': 'Urolithiasis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0077918', 'cui_str': 'Uromucoid protein'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0069676', 'cui_str': 'Osteopontin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0202125', 'cui_str': 'Magnesium measurement, serum'}]",60.0,0.231442,"The main outcome indicators included the Tamm-Horsfall protein (THP) expression levels, osteopontin, and inter-αtrypsin inhibitor heavy chain 3 (ITIH3) in the patients' urine as well as changes in 24-h urinary citric acid, urinary magnesium levels, and Traditional Chinese Medicine (TCM) syndrome scores. ","[{'ForeName': 'Xiao-Song', 'Initials': 'XS', 'LastName': 'Gao', 'Affiliation': 'Department of Urology, China Academy of Chinese medical Sciences Guanganmen Hospital, Beijing, China. gaoxiaosong56@163.com.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': 'Department of Laboratory, China Academy of Chinese medical Sciences Guanganmen Hospital, Beijing, China.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Pang', 'Affiliation': 'Department of Urology, China Academy of Chinese medical Sciences Guanganmen Hospital, Beijing, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, China Academy of Chinese medical Sciences Guanganmen Hospital, Beijing, China.'}, {'ForeName': 'Shu-Qi', 'Initials': 'SQ', 'LastName': 'Song', 'Affiliation': 'Department of Urology, China Academy of Chinese medical Sciences Guanganmen Hospital, Beijing, China.'}]",Annals of palliative medicine,['10.21037/apm-20-2295'] 3277,32919779,Aspirin use and ovarian cancer risk using extended follow-up of the PLCO Cancer Screening Trial.,"OBJECTIVE Frequent use of aspirin has been associated with reduced ovarian cancer risk in observational studies, but it is unclear if only daily, low-dose aspirin confers a protective benefit. We examined associations between patterns of aspirin use and ovarian cancer risk among postmenopausal women in the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial. METHODS Participants were enrolled in PLCO between 1993 and 2001 and followed for cancer outcomes through 2014. Detailed data on aspirin use (e.g., dose, frequency and duration) were ascertained via the supplemental questionnaire (SQX) administered in 2006-2007. We used Cox proportional hazards regression to calculate hazard ratios (HRs) and 95% confidence intervals (CIs) for associations between aspirin use (defined as use ≥once/week) and incident ovarian cancer. We conducted analyses among all women in the study sample and stratified by age at the time of the SQX. RESULTS There were 41,633 women included in this analysis, of whom 223 developed incident ovarian cancer. Overall, aspirin use was not significantly associated with ovarian cancer risk (HR: 0.93, 95% CI: 0.72-1.21). Among women <70 years, there was suggestion of an inverse association for daily use of aspirin (HR: 0.65, 95% CI: 0.40-1.05), low-dose aspirin (HR: 0.79, 95% CI: 0.51-1.24) and daily use of low-dose aspirin (HR: 0.64, 95% CI: 0.38-1.09). CONCLUSIONS These findings suggest a potential modest effect of daily, low-dose aspirin in reducing ovarian cancer risk. However, effect estimates were imprecise given the small number of events, and further research will be needed to confirm and extend these findings.",2020,"Overall, aspirin use was not significantly associated with ovarian cancer risk (HR: 0.93, 95% CI: 0.72-1.21).","['all women in the study sample and stratified by age at the time of the SQX', '41,633 women included in this analysis, of whom 223 developed incident ovarian cancer', 'Participants were enrolled in PLCO between 1993 and 2001 and followed for cancer outcomes through 2014', 'postmenopausal women in the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial']","['aspirin', 'Aspirin']",['ovarian cancer risk'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",41633.0,0.400824,"Overall, aspirin use was not significantly associated with ovarian cancer risk (HR: 0.93, 95% CI: 0.72-1.21).","[{'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Hurwitz', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, 9609 Medical Center Drive, Rockville, MD 20850, USA. Electronic address: lauren.hurwitz@nih.gov.'}, {'ForeName': 'Paul F', 'Initials': 'PF', 'LastName': 'Pinsky', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, 9609 Medical Center Drive, Rockville, MD 20850, USA.'}, {'ForeName': 'Wen-Yi', 'Initials': 'WY', 'LastName': 'Huang', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, 9609 Medical Center Drive, Rockville, MD 20850, USA.'}, {'ForeName': 'Neal D', 'Initials': 'ND', 'LastName': 'Freedman', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, 9609 Medical Center Drive, Rockville, MD 20850, USA.'}, {'ForeName': 'Britton', 'Initials': 'B', 'LastName': 'Trabert', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, 9609 Medical Center Drive, Rockville, MD 20850, USA.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.08.038'] 3278,32854972,Cost-effectiveness of apixaban for prevention of venous thromboembolic events in patients after gynecologic cancer surgery.,"OBJECTIVE The cost-effectiveness of apixaban was compared with enoxaparin for prevention of postoperative venothromboembolic events (VTE) in gynecologic oncology patients. Current guidelines recommend thromboprophylaxis with low molecular weight heparin for 28 days following gynecologic cancer surgery, but recent trials suggest that oral apixaban may be a safe, patient-preferred alternative. Apixaban was superior to enoxaparin in a Canadian cost-effectiveness analysis using orthopedics trial data. METHODS Medication costs, adherence rates, event rates, event costs, and utility decrements were estimated using prior clinical trial data and literature review for input into a short-term decision model to simulate outcomes in a hypothetical cohort of 1000 patients. Incremental cost-effectiveness ratios (ICERs) were calculated as net cost difference per quality-adjusted life year (QALY) gained. Input values at which net costs and QALYs were equivalent and ICERs at upper and lower bounds were evaluated. RESULTS Using aggregated costs, apixaban was less expensive and more effective than enoxaparin, and remained so or had high value in all scenarios on sensitivity analysis. Examining disaggregated ICERs, apixaban was cost-effective for deep venous thrombosis (DVT); of high value for clinically-relevant non-major bleeding (CRNMB) ($411); low value for major bleeding ($183,465), VTE-related death ($2,711,229), and all-cause mortality ($297,522); and not cost-effective for pulmonary embolism prevention. CONCLUSIONS Apixaban is more cost-effective than enoxaparin for the prevention of postoperative VTE in patients with gynecologic cancer. This appears to be driven largely by DVT and CRNMB prevention.",2020,"Examining disaggregated ICERs, apixaban was cost-effective for deep venous thrombosis (DVT); of high value for clinically-relevant non-major bleeding (CRNMB) ($411); low value for major bleeding ($183,465), VTE-related death ($2,711,229), and all-cause mortality ($297,522); and not cost-effective for pulmonary embolism prevention. ","['28\xa0days following gynecologic cancer surgery', 'patients with gynecologic cancer', 'gynecologic oncology patients', 'patients after gynecologic cancer surgery']","['enoxaparin', 'Apixaban', 'apixaban']","['adherence rates, event rates, event costs, and utility decrements', 'venous thromboembolic events', 'Incremental cost-effectiveness ratios (ICERs']","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0699889', 'cui_str': 'Female reproductive neoplasm malignant NOS'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1321164', 'cui_str': 'Gynecological oncology'}]","[{'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.110776,"Examining disaggregated ICERs, apixaban was cost-effective for deep venous thrombosis (DVT); of high value for clinically-relevant non-major bleeding (CRNMB) ($411); low value for major bleeding ($183,465), VTE-related death ($2,711,229), and all-cause mortality ($297,522); and not cost-effective for pulmonary embolism prevention. ","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Glickman', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Alyse', 'Initials': 'A', 'LastName': 'Brennecke', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tayebnejad', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Matsuo', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Southern California Keck School of Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Saketh R', 'Initials': 'SR', 'LastName': 'Guntupalli', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Jeanelle', 'Initials': 'J', 'LastName': 'Sheeder', 'Affiliation': 'Division of Family Planning, Department of Obstetrics and Gynecology, University of Colorado School of Medicine Anschutz Medical Campus, Aurora, CO, USA. Electronic address: jeanelle.sheeder@cuanschutz.edu.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.07.096'] 3279,31957625,Ten to fifteen seconds are needed for complete skin coverage with alcoholic hand disinfectant.,,2020,,[],[],[],[],[],[],,0.0300352,,"[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Schulz-Stübner', 'Affiliation': 'Deutsches Beratungszentrum für Hygiene (BZH GmbH), Freiburg, Germany.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Unger', 'Affiliation': 'Deutsches Beratungszentrum für Hygiene (BZH GmbH), Freiburg, Germany.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Berger', 'Affiliation': 'Deutsches Beratungszentrum für Hygiene (BZH GmbH), Freiburg, Germany.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Ebner', 'Affiliation': 'Institut für Infektionsprävention und Krankenhaushygiene Universitätsklinikum Freiburg, Freiburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hauer', 'Affiliation': 'Deutsches Beratungszentrum für Hygiene (BZH GmbH), Freiburg, Germany.'}]",Infection control and hospital epidemiology,['10.1017/ice.2019.382'] 3280,31837382,Analysis of the vaccine-induced influenza B virus hemagglutinin-specific antibody dependent cellular cytotoxicity response.,"Influenza A virus (IAV) and influenza B virus (IBV) cause substantial morbidity and mortality during seasonal epidemics. On basis of variation in the surface glycoprotein hemagglutinin, two antigenically distinct lineages of IBV are distinguished: B/Victoria/2/87-like (B/Vic) and B/Yamagata/16/88-like (B/Yam). To prevent IAV and IBV infections, both trivalent (containing IBV of one lineage) and quadrivalent (containing IBV of both lineages) influenza vaccines are used. In addition to virus-neutralizing antibodies, inactivated influenza vaccines induce antibodies that mediate antibody-dependent cellular cytotoxicity (ADCC). Here, we determine whether vaccination with trivalent or quadrivalent inactivated influenza vaccine induces ADCC mediating antibodies directed to IBV of the two different lineages, and whether these antibodies cross-react with IBV of the opposing lineage. A robust ADCC assay based on the use of recombinant hemagglutinin and a continuous natural killer cell line that expresses FcγRIII (CD16) was used to detect the presence of ADCC mediating antibodies. Paired pre- and post-vaccination serum samples from 26 and 15 study subjects that received a trivalent or quadrivalent inactivated influenza vaccine, respectively, were assessed for the presence of ADCC mediating antibodies specific for HA derived from viruses of the B/Vic or B/Yam-lineage. Furthermore, the relative contribution of HA1- and HA2-subunit-specific antibodies to the ADCC response was determined. We found that seasonal inactivated influenza vaccines induce HA-head- and HA-stalk-specific antibodies that mediate ADCC. As expected, the quadrivalent vaccine induced antibodies to HA from both IBV lineages. Notably, a trivalent vaccine containing HA from the B/Vic lineage induced antibodies that cross-react with the B/Yam lineage.",2020,"Paired pre- and post-vaccination serum samples from 26 and 15 study subjects that received a trivalent or quadrivalent inactivated influenza vaccine, respectively, were assessed for the presence of ADCC mediating antibodies specific for HA derived from viruses of the B/Vic or B/Yam-lineage.",[],"['trivalent or quadrivalent inactivated influenza vaccine', 'Influenza A virus (IAV) and influenza B virus (IBV']",['cellular cytotoxicity response'],[],"[{'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0029347', 'cui_str': 'Influenza A virus'}, {'cui': 'C0029348', 'cui_str': 'Influenza B virus'}]","[{'cui': 'C0301896', 'cui_str': 'Cell-mediated lympholysis'}]",,0.0163489,"Paired pre- and post-vaccination serum samples from 26 and 15 study subjects that received a trivalent or quadrivalent inactivated influenza vaccine, respectively, were assessed for the presence of ADCC mediating antibodies specific for HA derived from viruses of the B/Vic or B/Yam-lineage.","[{'ForeName': 'Rory D', 'Initials': 'RD', 'LastName': 'de Vries', 'Affiliation': 'Department of Viroscience, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'Nella J', 'Initials': 'NJ', 'LastName': 'Nieuwkoop', 'Affiliation': 'Department of Viroscience, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Krammer', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Branda', 'Initials': 'B', 'LastName': 'Hu', 'Affiliation': 'Global Clinical Immunology Department, Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Guus F', 'Initials': 'GF', 'LastName': 'Rimmelzwaan', 'Affiliation': 'Department of Viroscience, Erasmus MC, Rotterdam, the Netherlands. Electronic address: Guus.rimmelzwaan@tiho-hannover.de.'}]",Virus research,['10.1016/j.virusres.2019.197839'] 3281,33462883,IMpower132: Atezolizumab plus platinum-based chemotherapy vs chemotherapy for advanced NSCLC in Japanese patients.,"IMpower132 explored the safety and efficacy of atezolizumab plus pemetrexed and platinum-based chemotherapy as first-line treatment for advanced non-small-cell lung cancer (NSCLC). Key eligibility criteria for the phase 3, open-label, IMpower132 study included age ≥18 y, histologically or cytologically confirmed advanced non-squamous NSCLC per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, Eastern Cooperative Oncology Group performance status of 0/1, and no prior systemic treatment for stage IV NSCLC. Patients received atezolizumab (1200 mg) plus pemetrexed (500 mg/m 2 ) and cisplatin (75 mg/m 2 ) or carboplatin (area under the concentration curve, 6 mg/mL/min) (APP arm) or chemotherapy alone (PP arm). The co-primary study endpoints were overall survival (OS) and investigator-assessed progression-free survival (PFS) per RECIST 1.1 in the intention-to-treat population. A subgroup analysis was conducted in Japanese patients. In the Japanese subgroup (n = 101), median OS was 30.8 (95% CI, 24.3 to not estimable) mo in the APP arm (n = 48) and 22.2 (95% CI, 15.7-30.8) mo in the PP arm (n = 53; hazard ratio [HR], 0.63 [95% CI, 0.36-1.14]). PFS was 12.8 (95% CI, 8.6-16.6) mo in the APP arm vs 4.5 (95% CI, 4.1-6.7) mo in the PP arm (HR, 0.33 [95% CI, 0.21-0.58]). Grade 3/4 treatment-related adverse events (TRAEs) occurred in 68.8% of APP arm patients and 44.2% of PP arm patients. Consistent with global study results, atezolizumab plus pemetrexed and platinum-based chemotherapy improved efficacy and was well tolerated in Japanese patients with advanced NSCLC despite a higher incidence of grade 3/4 TRAEs.",2021,"PFS was 12.8 (95% CI, 8.6-16.6) mo in the APP arm vs 4.5 (95% CI, 4.1-6.7) mo in the PP arm (HR, 0.33 [95% CI, 0.21-0.58]).","['Japanese patients', 'Key eligibility criteria for the phase 3, open-label, IMpower132 study included age ≥18\xa0y, histologically or cytologically confirmed advanced non-squamous NSCLC per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, Eastern Cooperative Oncology Group performance status of 0/1, and no prior systemic treatment for stage IV NSCLC', 'advanced non-small-cell lung cancer (NSCLC', 'Japanese patients with advanced NSCLC']","['atezolizumab plus pemetrexed and platinum-based chemotherapy', 'APP', 'cisplatin', 'carboplatin (area under the concentration curve, 6\xa0mg/mL/min) (APP arm) or chemotherapy alone', 'pemetrexed', 'atezolizumab', 'IMpower132: Atezolizumab plus platinum-based chemotherapy vs chemotherapy']","['overall survival (OS) and investigator-assessed progression-free survival (PFS', 'safety and efficacy', 'PFS', 'median OS', 'Grade 3/4 treatment-related adverse events (TRAEs']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4324656', 'cui_str': 'Non-squamous non-small cell lung cancer'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.19023,"PFS was 12.8 (95% CI, 8.6-16.6) mo in the APP arm vs 4.5 (95% CI, 4.1-6.7) mo in the PP arm (HR, 0.33 [95% CI, 0.21-0.58]).","[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Nishio', 'Affiliation': 'Department of Thoracic Medical Oncology, The Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Haruhiro', 'Initials': 'H', 'LastName': 'Saito', 'Affiliation': 'Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Goto', 'Affiliation': 'Division of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Watanabe', 'Affiliation': 'Department of Respiratory Medicine and Infectious Diseases, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Sueoka-Aragane', 'Affiliation': 'Division of Hematology, Respiratory Medicine and Oncology, Faculty of Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Okuma', 'Affiliation': 'Department of Respiratory Medicine and Thoracic Oncology, Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hospital, Tokyo, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Kasahara', 'Affiliation': 'Department of Respiratory Medicine, Kanazawa University Hospital, Kanazawa, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Chikamori', 'Affiliation': 'Department of Medical Oncology, National Hospital Organization Yamaguchi-Ube Medical Center, Ube, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Nakagawa', 'Affiliation': 'Chugai Pharmaceutical co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Tomohisa', 'Initials': 'T', 'LastName': 'Kawakami', 'Affiliation': 'Chugai Pharmaceutical co., Ltd, Tokyo, Japan.'}]",Cancer science,['10.1111/cas.14817'] 3282,33291645,Lipidemic Profile Changes over a Two-Year Intervention Period: Who Benefited Most from the Feel4Diabetes Program?,"Identification of participants' characteristics who benefited most from large community-based intervention studies may guide future prevention initiatives in order to maximize their effectiveness. The current study aimed to examine the socio-demographic, anthropometric, and behavioral characteristics, as well as the health and eating perceptions of those who improved their lipidemic profile, in the Feel4Diabetes early screening and prevention program. In the present analyses, 1773 adults from families at high risk for developing type 2 diabetes mellitus (T2DM) were enrolled, receiving either the standard care or the more intensive intervention, and 33.3-55.2% of them improved one or more of their lipidemic indices by >5%. Women, people living in Southeastern Europe, coming from two-parent families, having higher financial security, educational level and better diet quality were associated with a 27-64% higher likelihood for benefiting from the program regarding one or more of their lipidemic profile indices. Participants who were overweight or obese (especially with central obesity), employed, with prolonged sedentary behavior, prone to emotional eating and perceiving their weight status as lower than their actual weight were 24-43% less likely to have benefited. These findings should guide future interventions, prioritizing regions in greater need, and being tailor-made to specific population characteristics in order to further improve their effectiveness.",2020,"These findings should guide future interventions, prioritizing regions in greater need, and being tailor-made to specific population characteristics in order to further improve their effectiveness.","['Participants who were overweight or obese (especially with central obesity), employed, with prolonged sedentary behavior, prone to emotional eating and perceiving their weight status as lower than their actual weight were 24-43% less likely to have benefited', 'Women, people living in Southeastern Europe', '1773 adults from families at high risk for developing type 2 diabetes mellitus (T2DM']",[],"['financial security, educational level and better diet quality']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]",[],"[{'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",1773.0,0.0361769,"These findings should guide future interventions, prioritizing regions in greater need, and being tailor-made to specific population characteristics in order to further improve their effectiveness.","[{'ForeName': 'Kalliopi', 'Initials': 'K', 'LastName': 'Karatzi', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, 17671 Athens, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Moschonis', 'Affiliation': 'Department of Dietetics, Nutrition and Sport, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, VIC 3086, Australia.'}, {'ForeName': 'Eirini', 'Initials': 'E', 'LastName': 'Botsi', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, 17671 Athens, Greece.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Liatis', 'Affiliation': 'National and Kapodistrian University of Athens Medical School, 11527 Athens, Greece.'}, {'ForeName': 'Kaloyan', 'Initials': 'K', 'LastName': 'Tsochev', 'Affiliation': 'Department of Paediatrics, Medical University Varna, 9002 Varna, Bulgaria.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'De Miguel-Etayo', 'Affiliation': 'Growth, Exercise, Nutrition and Development (GENUD) Research Group, Instituto Agroalimentario de Aragón (IA2), Instituto de Investigación Sanitaria de Aragón (IIS Aragón), Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Jemina', 'Initials': 'J', 'LastName': 'Kivelä', 'Affiliation': 'Department of Public Health Solutions, Finnish Institute for Health and Welfare, 00271 Helsinki, Finland.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wikström', 'Affiliation': 'Department of Public Health Solutions, Finnish Institute for Health and Welfare, 00271 Helsinki, Finland.'}, {'ForeName': 'Roumyana', 'Initials': 'R', 'LastName': 'Dimova', 'Affiliation': 'Department of Diabetology, Clinical Center of Endocrinology, Medical University Sofia, 1431 Sofia, Bulgaria.'}, {'ForeName': 'Emese', 'Initials': 'E', 'LastName': 'Antal', 'Affiliation': 'Hungarian Society of Nutrition, 1088 Budapest, Hungary.'}, {'ForeName': 'Itziar', 'Initials': 'I', 'LastName': 'Lamiquiz-Moneo', 'Affiliation': 'Hospital Universitario Miguel Servet, Instituto de Investigación Sanitaria Aragón (IIS Aragón), CIBERCV, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Imre', 'Initials': 'I', 'LastName': 'Rurik', 'Affiliation': 'Hungarian Society of Nutrition, 1088 Budapest, Hungary.'}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'Cardon', 'Affiliation': 'Department of Movement and Sports Sciences, Faculty of Medicine and Health Sciences, Ghent University, 9000 Gent, Belgium.'}, {'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'Iotova', 'Affiliation': 'Department of Paediatrics, Medical University Varna, 9002 Varna, Bulgaria.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Makrilakis', 'Affiliation': 'National and Kapodistrian University of Athens Medical School, 11527 Athens, Greece.'}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Manios', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, 17671 Athens, Greece.'}, {'ForeName': '', 'Initials': '', 'LastName': 'On Behalf Of The Feel Diabetes-Study Group', 'Affiliation': ''}]",Nutrients,['10.3390/nu12123736'] 3283,33838012,Economic evaluation of differentiated service delivery models for HIV treatment in Lesotho: costs to providers and patients.,"INTRODUCTION Lesotho, the country with the second-highest HIV/AIDS prevalence (23.6%) in the world, has made considerable progress towards achieving the ""95-95-95"" UNAIDS targets, but recent success in improving treatment access to all known HIV positive individuals has severely strained existing healthcare infrastructure, financial and human resources. Lesotho also faces the challenge of a largely rural population who incur a significant time and financial burden to visit healthcare facilities. Using data from a cluster-randomized non-inferiority trial conducted between August 2017 and July 2019, we evaluated costs to providers and costs to patients of community-based differentiated models of multi-month delivery of antiretroviral therapy (ART) in Lesotho. METHODS The trial of multi-month dispensing compared 12-month retention in care among three arms: conventional care, which required quarterly facility visits and ART dispensation (3MF); three-month community adherence groups (CAGs) (3MC) and six-month community ART distribution (6MCD). We first estimated the average total annual cost of providing HIV care and treatment followed by the total cost per patient retained 12 months after entry for each arm, using resource utilization data from the trial and local unit costs. We then estimated the average annual cost to patients in each arm with self-reported questionnaire data. RESULTS The average total annual cost of providing HIV care and treatment per patient was the highest in the 3MF arm ($122.28, standard deviation [SD] $23.91), followed by 3MC ($114.20, SD $23.03) and the 6MCD arm ($112.58, SD $21.44). Per patient retained in care, the average provider cost was $125.99 (SD $24.64) in the 3MF arm and 6% to 8% less for the other two arms ($118.38, SD $23.87 and $118.83, SD $22.63 for the 3MC and 6MCD respectively). There was a large reduction in patient costs for both differentiated service delivery arms: from $44.42 (SD $12.06) annually in the 3MF arm to $16.34 (SD $5.11) annually in the 3MC (63% reduction) and $18.77 (SD $8.31) annually in 6MCD arm (58% reduction). CONCLUSIONS Community-based, multi-month models of ART in Lesotho are likely to produce small cost savings to treatment providers and large savings to patients in Lesotho. Patient cost savings may support long-term adherence and retention in care.",2021,"There was a large reduction in patient costs for both differentiated service delivery arms: from $44.42 (SD $12.06) annually in the 3MF arm to $16.34 (SD $5.11) annually in the 3MC (63% reduction) and $18.77 (SD $8.31) annually in 6MCD arm (58% reduction). ","['August 2017 and July 2019, we evaluated costs to providers and costs to patients of community-based differentiated models of multi-month delivery of antiretroviral therapy (ART) in Lesotho', 'HIV treatment in Lesotho']","['conventional care, which required quarterly facility visits and ART dispensation (3MF); three-month community adherence groups (CAGs) (3MC) and six-month community ART distribution (6MCD']","['average provider cost', 'patient costs', 'average total annual cost of providing HIV care']","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0023376', 'cui_str': 'Lesotho'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",,0.172335,"There was a large reduction in patient costs for both differentiated service delivery arms: from $44.42 (SD $12.06) annually in the 3MF arm to $16.34 (SD $5.11) annually in the 3MC (63% reduction) and $18.77 (SD $8.31) annually in 6MCD arm (58% reduction). ","[{'ForeName': 'Brooke E', 'Initials': 'BE', 'LastName': 'Nichols', 'Affiliation': 'Department of Global Health, School of Public Health, Boston University, Boston, MA, USA.'}, {'ForeName': 'Refiloe', 'Initials': 'R', 'LastName': 'Cele', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Nkgomeleng', 'Initials': 'N', 'LastName': 'Lekodeba', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Tukei', 'Affiliation': 'Right to Care, Centurion, South Africa.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Ngorima-Mabhena', 'Affiliation': ""Kheth'Impilo AIDS Free Living, Cape Town, South Africa.""}, {'ForeName': 'Appolinaire', 'Initials': 'A', 'LastName': 'Tiam', 'Affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation, USA.'}, {'ForeName': 'Thapelo', 'Initials': 'T', 'LastName': 'Maotoe', 'Affiliation': 'Right to Care, Centurion, South Africa.'}, {'ForeName': 'Makatleho Veronica', 'Initials': 'MV', 'LastName': 'Sejana', 'Affiliation': 'EQUIP Lesotho, Maseru, Lesotho.'}, {'ForeName': 'Iyiola O', 'Initials': 'IO', 'LastName': 'Faturiyele', 'Affiliation': 'Department of Epidemiology & Biostatistics, School of Public Health, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Chasela', 'Affiliation': 'Right to Care, Centurion, South Africa.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Rosen', 'Affiliation': 'Department of Global Health, School of Public Health, Boston University, Boston, MA, USA.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Fatti', 'Affiliation': ""Kheth'Impilo AIDS Free Living, Cape Town, South Africa.""}]",Journal of the International AIDS Society,['10.1002/jia2.25692'] 3284,33837987,Changes in surgical revascularization strategy after fractional flow reserve.,"AIMS In the randomized GRAFFITI trial, surgeons drew their strategy based on coronary angiography. When patients were randomized to fractional flow reserve (FFR)-guidance, surgeons were informed of the FFR values and asked to redraw their strategy. The aim of this study was to investigate the changes induced by FFR knowledge. METHODS AND RESULTS The intended and performed strategy (before and after FFR) were compared. Among 172 patients, 84 with 300 lesions were randomized to the FFR-guided group. The intended strategy was to bypass 236 stenoses:108 with a venous and 128 with an arterial graft. After disclosing FFR, a change in strategy occurred in 64 lesions (21.3%) of 48 (55%) patients. Among 64 lesions for which the intended strategy was medical therapy, 16 (25%) were bypassed after disclosing FFR. The number of procedures with >1 venous graft planned was significantly reduced from 37 to 27 patients (p = .031). The proportion of on-pump surgery was significantly reduced from 71 to 61 patients (p = .006). The rates of clinical events at 1 year were similar between patients with or without at least one change in strategy. DISCUSSION FFR-guided CABG is associated with a simplified surgical procedure in 55% of the patients, with similar clinical outcomes.",2021,"FFR-guided CABG is associated with a simplified surgical procedure in 55% of the patients, with similar clinical outcomes.","['172 patients, 84 with 300 lesions']","['FFR-guided group', 'FFR-guided CABG']","['number of procedures with >1 venous graft planned', 'proportion of on-pump surgery', 'rates of clinical events']","[{'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.0296819,"FFR-guided CABG is associated with a simplified surgical procedure in 55% of the patients, with similar clinical outcomes.","[{'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Fournier', 'Affiliation': 'Department of Cardiology, Lausanne University Center Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Gabor G', 'Initials': 'GG', 'LastName': 'Toth', 'Affiliation': 'University Heart Center Graz, Department of Cardiology, Medical University Graz, Graz, Austria.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'De Bruyne', 'Affiliation': 'Department of Cardiology, Lausanne University Center Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Kala', 'Affiliation': 'Department of Cardiology and Internal Medicine, University Hospital Brno and Medical Faculty of Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Flavio L', 'Initials': 'FL', 'LastName': 'Ribichini', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Verona, Verona, Italy.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Casselman', 'Affiliation': 'Cardiovascular Research Center Aalst, OLV Clinic, Aalst, Belgium.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Ramos', 'Affiliation': 'Department of Cardiology, Hospital Santa Marta-Centro Hospitalar Lisboa Central, Lisbon, Portugal.'}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Piroth', 'Affiliation': 'Department of Cardiology, Hungarian Institute of Cardiology, Budapest, Hungary.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Piccoli', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Verona, Verona, Italy.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Penicka', 'Affiliation': 'Cardiovascular Research Center Aalst, OLV Clinic, Aalst, Belgium.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Mates', 'Affiliation': 'Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Nemec', 'Affiliation': 'Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Van Praet', 'Affiliation': 'Cardiovascular Research Center Aalst, OLV Clinic, Aalst, Belgium.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Stockman', 'Affiliation': 'Cardiovascular Research Center Aalst, OLV Clinic, Aalst, Belgium.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Degriek', 'Affiliation': 'Cardiovascular Research Center Aalst, OLV Clinic, Aalst, Belgium.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Pellicano', 'Affiliation': 'Cardiovascular Research Center Aalst, OLV Clinic, Aalst, Belgium.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Barbato', 'Affiliation': 'Cardiovascular Research Center Aalst, OLV Clinic, Aalst, Belgium.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.29694'] 3285,33839035,"Corrigendum to ""Parasacral transcutaneous electrical neural stimulation (PTENS) once a week for the treatment of overactive bladder in children: A randomized controlled trialˮ [J Pediatr Urol 13 (2017) 263.e1-236.e6].",,2021,,['overactive bladder in children'],['Parasacral transcutaneous electrical neural stimulation (PTENS'],[],"[{'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C1430988', 'cui_str': 'PTEN protein, human'}]",[],,0.074482,,"[{'ForeName': 'Lidyanne Ilidia da Silva', 'Initials': 'LIDS', 'LastName': 'de Paula', 'Affiliation': 'Division of Urology, Department of Surgery, Federal University of Juiz de Fora (UFJF), MG, Brazil.'}, {'ForeName': 'Liliana Fajardo', 'Initials': 'LF', 'LastName': 'de Oliveira', 'Affiliation': 'Division of Urology, Department of Surgery, Federal University of Juiz de Fora (UFJF), MG, Brazil.'}, {'ForeName': 'Brysa Paiva', 'Initials': 'BP', 'LastName': 'Cruz', 'Affiliation': 'Division of Urology, Department of Surgery, Federal University of Juiz de Fora (UFJF), MG, Brazil.'}, {'ForeName': 'Dayana Maria', 'Initials': 'DM', 'LastName': 'de Oliveira', 'Affiliation': 'Division of Urology, Department of Surgery, Federal University of Juiz de Fora (UFJF), MG, Brazil.'}, {'ForeName': 'Laıs Maini', 'Initials': 'LM', 'LastName': 'Miranda', 'Affiliation': 'Division of Urology, Department of Surgery, Federal University of Juiz de Fora (UFJF), MG, Brazil.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'de Moraes Ribeiro', 'Affiliation': 'Division of Urology, Department of Surgery, Federal University of Juiz de Fora (UFJF), MG, Brazil.'}, {'ForeName': 'Raphaela Ornellas', 'Initials': 'RO', 'LastName': 'Duque', 'Affiliation': 'Division of Urology, Department of Surgery, Federal University of Juiz de Fora (UFJF), MG, Brazil.'}, {'ForeName': 'Andre Avarese', 'Initials': 'AA', 'LastName': 'Figueiredo', 'Affiliation': 'Division of Urology, Department of Surgery, Federal University of Juiz de Fora (UFJF), MG, Brazil.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'de Bessa', 'Affiliation': 'Division of Urology, Department of Surgery, State University of Feira de Santana (UEFS), BA, Brazil.'}, {'ForeName': 'Jose Murillo B', 'Initials': 'JMB', 'LastName': 'Netto', 'Affiliation': 'Division of Urology, Department of Surgery, Federal University of Juiz de Fora (UFJF), MG, Brazil; Division of Urology, Department of Surgery, Hospital and Maternity Therezinha de Jesus da Faculdade de Ciências Médicas e da Saúde de Juiz de For a (HMTJ/Suprema), MG, Brazil. Electronic address: jose.murillo@ufjf.edu.br.'}]",Journal of pediatric urology,['10.1016/j.jpurol.2021.03.015'] 3286,33838950,"[For obese patients or for patients who are overweight and have an associated comorbidity, how safe and effective is semaglutide as compared with placebo as an adjunct to lifestyle intervention for reducing body weight and other related end points?]",,2021,,[],['placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0460906,,"[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Lanthier', 'Affiliation': 'Service de médecine interne générale, département de médecine spécialisé, Université de Sherbrooke, Sherbrooke, QC, Canada. Electronic address: luc.lanthier@usherbrooke.ca.'}, {'ForeName': 'M-F', 'Initials': 'MF', 'LastName': 'Langlois', 'Affiliation': ""Service d'endocrinologie, département de médecine spécialisé, Université de Sherbrooke, Sherbrooke, QC, Canada.""}, {'ForeName': 'M-É', 'Initials': 'MÉ', 'LastName': 'Plourde', 'Affiliation': 'Service de radio-oncologie, département de médecine nucléaire et radiobiologie, Université de Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cauchon', 'Affiliation': ""Département de médecine familiale et de médecine d'urgence, Université Laval, Québec, QC, Canada.""}]",La Revue de medecine interne,['10.1016/j.revmed.2021.03.334'] 3287,33838918,"Digital versus conventional complete dentures: A randomized, controlled, blinded study.","STATEMENT OF PROBLEM Several manufacturers have developed a digital workflow for removable prosthodontics. The Baltic Denture System is a 2-visit procedure for the digital production of complete dentures, but clinical studies comparing the system with conventional methods are lacking. PURPOSE The purpose of this randomized, controlled, blinded crossover trial was to evaluate the impact of the digital versus conventional production of complete dentures on oral health-related quality of life (OHRQoL) measures. MATERIAL AND METHODS Sixteen participants received 2 sets of new complete dentures produced with a digital (2 visits) and conventional (5 visits) workflow. Each complete denture was in clinical service for an observation period of 3 months. The order of the dentures was randomized, starting with digital or conventional followed by changing the set of dentures after 3 months. The primary outcome was the time-dependent change in the OHRQoL, assessed by using the Oral Health Impact Profile, German version (OHIP-G49), comparing the digital with the conventional workflow. The secondary outcome was the time needed for the fabrication process. The median values of OHIP-G49 total sum scores and OHIP-G49 dimensions were calculated for baseline and 14 days and 3 months after insertion of the dentures. Changes of sum scores over time and differences between the workflows were analyzed by using the Wilcoxon signed-rank test (α=.05). RESULTS The data of 16 participants (11 men and 5 women; 66 ±8.5 years) were evaluated. The median values of the total OHIP-G49 sum scores and the sum scores of OHIP-G49 dimensions did not differ between workflows (P>.05). With digital dentures, more physical pain was observed after 2 weeks (P=.039). Participants with conventional dentures had less functional limitation after 14 days and felt less handicapped after 3 months (P=.036). Digital dentures were fabricated within 4 hours, whereas fabrication of conventional dentures took 10.5 hours for dentists and dental laboratory technicians. CONCLUSIONS From the perspective of the participants, the fabrication method of the complete dentures had no significant influence on OHRQoL. However, digital dentures needed only 2 visits, 1 hour less chair time, and 5 hours less time for the dental laboratory technicians.",2021,Participants with conventional dentures had less functional limitation after 14 days and felt less handicapped after 3 months (P=.036).,"['16 participants (11 men and 5 women; 66 ±8.5 years', 'Sixteen participants received 2 sets of new complete dentures produced with a digital (2 visits) and conventional (5 visits) workflow']",['Digital versus conventional complete dentures'],"['median values of OHIP-G49 total sum scores and OHIP-G49 dimensions', 'oral health-related quality of life (OHRQoL) measures', 'time-dependent change in the OHRQoL, assessed by using the Oral Health Impact Profile, German version (OHIP-G49), comparing the digital with the conventional workflow', 'time needed for the fabrication process', 'physical pain', 'median values of the total OHIP-G49 sum scores and the sum scores of OHIP-G49 dimensions', 'functional limitation', 'OHRQoL']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0011455', 'cui_str': 'Complete denture'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1710679', 'cui_str': 'Work Flow'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0011455', 'cui_str': 'Complete denture'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1710679', 'cui_str': 'Work Flow'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]",,0.200623,Participants with conventional dentures had less functional limitation after 14 days and felt less handicapped after 3 months (P=.036).,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Peroz', 'Affiliation': 'Research Associate, Charité, CC 3 Dental and Craniofacial Sciences, Department of Prosthodontics, Geriatric Dentistry and Craniomandibular Disorders, Universitätsmedizin Berlin, Campus Benjamin Franklin (CBF), Berlin, Germany. Electronic address: simon.peroz@charite.de.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Peroz', 'Affiliation': 'Professor, Charité, CC 3 Dental and Craniofacial Sciences, Department of Prosthodontics, Geriatric Dentistry and Craniomandibular Disorders, Universitätsmedizin Berlin, Campus Benjamin Franklin (CBF), Berlin, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Beuer', 'Affiliation': 'Professor, Charité, CC 3 Dental and Craniofacial Sciences, Department of Prosthodontics, Geriatric Dentistry and Craniomandibular Disorders, Universitätsmedizin Berlin, Campus Benjamin Franklin (CBF), Berlin, Germany.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Sterzenbach', 'Affiliation': 'Associate Professor, Charité, CC 3 Dental and Craniofacial Sciences, Department of Prosthodontics, Geriatric Dentistry and Craniomandibular Disorders, Universitätsmedizin Berlin, Campus Benjamin Franklin (CBF), Berlin, Germany.'}, {'ForeName': 'Manja', 'Initials': 'M', 'LastName': 'von Stein-Lausnitz', 'Affiliation': 'Associate Professor, Charité, CC 3 Dental and Craniofacial Sciences, Department of Prosthodontics, Geriatric Dentistry and Craniomandibular Disorders, Universitätsmedizin Berlin, Campus Benjamin Franklin (CBF), Berlin, Germany.'}]",The Journal of prosthetic dentistry,['10.1016/j.prosdent.2021.02.004'] 3288,33838898,Early enteral feeding versus traditional feeding in neonatal congenital gastrointestinal malformation undergoing intestinal anastomosis: A randomized multicenter controlled trial of an enhanced recovery after surgery (ERAS) component.,"PURPOSE the aim of this clinical trial was to evaluate the safety and efficacy of early enteral feeding (EEN) following intestinal anastomosis in neonates with congenital gastrointestinal malformation. METHODS a multicenter, prospective, randomized controlled trial (registered under chictr.org.cn Identifier no.ChiCTR-INR-17014179) was conducted between 2018 and 2019. Four centers in China analyzed 156 newborns of congenital gastrointestinal malformation undergoing intestinal anastomosis to EEN group (n = 78) or control (C) group (n = 78). The primary outcomes of this study were length of postoperative stay (LOPS) and time to full feeds. Secondary outcomes included morbidity of complications, parenteral nutrition (PN) duration, feeding intolerance, 30 day mortality rate and 30 day readmission rate. RESULTS the mean time to full feeds and LOPS in the EEN group were 15.0 (9.8-22.8) days and 17.6 (12.0-29.8) days, while that were 18.0 (12.0-24.0) days and 20.0 (15.0-30.3) days in C groups respectively. There was no significant difference between two groups(P >0.05). No significant intergroup difference was found with respect to postoperative morbidity, PN duration or feeding intolerance(P >0.05). CONCLUSIONS early enteral feeding following intestinal anastomosis in neonates with congenital gastrointestinal malformation is safe. Post-operative outcomes demonstrated a trend toward improvement. LEVEL OF EVIDENCE Level Ⅰ.",2021,"No significant intergroup difference was found with respect to postoperative morbidity, PN duration or feeding intolerance(P >0.05). ","['neonates with congenital gastrointestinal malformation', 'Four centers in China analyzed 156 newborns of congenital gastrointestinal malformation undergoing intestinal anastomosis to EEN group (n\xa0=\xa078) or control (C) group (n\xa0=\xa078', 'neonatal congenital gastrointestinal malformation undergoing intestinal anastomosis']","['early enteral feeding (EEN', 'Early enteral feeding versus traditional feeding']","['safety and efficacy', 'length of postoperative stay (LOPS) and time to full feeds', 'postoperative morbidity, PN duration or feeding intolerance(P\xa0>0.05', 'morbidity of complications, parenteral nutrition (PN) duration, feeding intolerance, 30 day mortality rate and 30 day readmission rate', 'mean time to full feeds and LOPS']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0012241', 'cui_str': 'Congenital anomaly of gastrointestinal tract'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1820738', 'cui_str': 'Feeding intolerance'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.121417,"No significant intergroup difference was found with respect to postoperative morbidity, PN duration or feeding intolerance(P >0.05). ","[{'ForeName': 'Yanfen', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': ""Department of Neonatal Surgery, Guangzhou Women and Children's Medical Center, Guangzhou, China.""}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Xiao', 'Affiliation': ""Department of General Surgery, Shenzhen Children's Hospital, Shenzhen, China.""}, {'ForeName': 'Shangjie', 'Initials': 'S', 'LastName': 'Xiao', 'Affiliation': ""Department of Neonatal Surgery, Guangdong Women and Children's Hospital, Guangdong, China.""}, {'ForeName': 'Liucheng', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of General Surgery, Zhujiang Hospital of Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': ""Guangzhou Women and Children's Medical Center, Institute of Pediatrics, Guangzhou, China.""}, {'ForeName': 'Qiuming', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': ""Department of Neonatal Surgery, Guangzhou Women and Children's Medical Center, Guangzhou, China.""}, {'ForeName': 'Haozhong', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': ""Department of General Surgery, Shenzhen Children's Hospital, Shenzhen, China.""}, {'ForeName': 'Xiaochun', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': ""Department of Neonatal Surgery, Guangdong Women and Children's Hospital, Guangdong, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhong', 'Affiliation': ""Department of Neonatal Surgery, Guangzhou Women and Children's Medical Center, Guangzhou, China.""}, {'ForeName': 'Jiakang', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': ""Department of Neonatal Surgery, Guangzhou Women and Children's Medical Center, Guangzhou, China. Electronic address: jiakangyu@hotmail.com.""}]",Journal of pediatric surgery,['10.1016/j.jpedsurg.2021.02.067'] 3289,33838870,Gonadotropin response to insulin and lipid infusion reproduces the reprometabolic syndrome of obesity in eumenorrheic lean women: a randomized crossover trial.,"OBJECTIVE To study the reprometabolic syndrome in normal-weight, eumenorrheic women by infusing a combination of insulin and lipid. Women with obesity have been shown to have reduced gonadotropins and impaired luteinizing hormone (LH) and follicle-stimulating hormone (FSH) response to gonadotropin-releasing hormone (GnRH). DESIGN Randomized crossover. SETTING Academic medical center. PARTICIPANT(S) Fifteen women, median age 32 (interquartile ranged [IQR] 26, 36) years and body mass index 21.9 (IQR 20.2, 22.9) kg/m 2 were recruited. INTERVENTION(S) Early follicular phase, 6-hour infusions of insulin (20-40 mU/m 2 per minute) and lipid (Intralipid)-insulin/lipid infusion; or saline infusion (controls). The first 4 hours of each study assessed endogenous gonadotropins; at 4 hours, GnRH (75 ng/kg) bolus was administered and sampling continued until 6 hours. MAIN OUTCOME MEASURE(S) Linear mixed model analysis was used to determine differences between insulin/lipid and saline influence on endogenous LH pulse amplitude (primary outcome), mean FSH, and area under the curve (AUC) response to GnRH (secondary outcomes). RESULT(S) Twelve women completed both intended studies and an additional 3 women completed only 1 of the 2 studies. LH pulse amplitude, mean FSH, and both AUC responses to GnRH were reduced by insulin/lipid, mean FSH and AUC for LH were at or near statistical significance. LH response to GnRH was significantly reduced when 1 participant with very high LH and antimullerian hormone levels was excluded. CONCLUSION(S) Acute infusion of insulin/lipid to eumenorrheic, normal-weight women recapitulated the reprometabolic syndrome of obesity. These findings imply that specific circulating factors in obese women contribute to their subfertility and thus may be amenable to discovery and treatment. CLINICAL TRIAL REGISTRATION NUMBER NCT02653092.",2021,"LH response to GnRH was significantly reduced when 1 participant with very high LH and antimullerian hormone levels was excluded. ","['obese women', 'eumenorrheic lean women', '\n\n\nFifteen women, median age 32 (interquartile ranged [IQR] 26, 36) years and body mass index 21.9 (IQR 20.2, 22.9) kg/m 2 were recruited', 'Women with obesity', 'Academic medical center', 'Twelve women completed both intended studies and an additional 3 women completed only 1 of the 2 studies']","['lipid (Intralipid)-insulin/lipid infusion; or saline infusion (controls', 'insulin and lipid', 'insulin and lipid infusion reproduces']","['LH pulse amplitude, mean FSH, and both AUC responses to GnRH', 'endogenous LH pulse amplitude (primary outcome), mean FSH, and area under the curve (AUC) response to GnRH (secondary outcomes', 'luteinizing hormone (LH) and follicle-stimulating hormone (FSH) response', 'Gonadotropin response', 'endogenous gonadotropins', 'LH response to GnRH']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517642', 'cui_str': '20.2'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0018061', 'cui_str': 'Gonadotropin'}]",12.0,0.2955,"LH response to GnRH was significantly reduced when 1 participant with very high LH and antimullerian hormone levels was excluded. ","[{'ForeName': 'Nanette', 'Initials': 'N', 'LastName': 'Santoro', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado School of Medicine, Aurora, Colorado. Electronic address: Nanette.Santoro@cuanschutz.edu.'}, {'ForeName': 'Irene E', 'Initials': 'IE', 'LastName': 'Schauer', 'Affiliation': 'Department of Medicine (Endocrinology), University of Colorado School of Medicine, Aurora, Colorado; Department of Medicine, Rocky Mountain Regional Veterans Affairs Medical Center, Aurora, Colorado.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Kuhn', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'Angela J', 'Initials': 'AJ', 'LastName': 'Fought', 'Affiliation': 'Biostatistics and Informatics, Colorado School of Public Health, Aurora, Colorado.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Babcock-Gilbert', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Bradford', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado School of Medicine, Aurora, Colorado.'}]",Fertility and sterility,['10.1016/j.fertnstert.2021.03.005'] 3290,33838678,Supporting Parents & Kids Through Lockdown Experiences (SPARKLE): A digital parenting support app implemented in an ongoing general population cohort study during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES The COVID-19 related lockdowns and distancing measures have presented families with unprecedented challenges. A UK-wide cohort study tracking changes in families' mental health since early lockdown (Co-SPACE) found a significant rise in primary school-aged children's behaviour problems and associated family-related stress. Three-quarters of parents in Co-SPACE also reported wanting extra support. In SPARKLE, we will examine whether providing Co-SPACE families with a smartphone application delivering information and parenting support, Parent Positive, can reverse the negative effects of the pandemic on children and parents. The efficacy on child and parent outcomes and cost-effectiveness of Parent Positive will be examined. We will also test whether the effects are moderated by pre-existing levels of child conduct problems and usage of Parent Positive. Exploratory analyses will examine whether other baseline characteristics or lockdown circumstances moderate the effects of Parent Positive. TRIAL DESIGN SPARKLE is a two-arm superiority parallel group randomised controlled trial embedded in an existing large UK-wide self-selected community cohort - Co-SPACE. Those who consent to SPARKLE will be randomised 1:1 to either Parent Positive or Follow-up As Usual (FAU). PARTICIPANTS Co-SPACE (a UK-wide longitudinal cohort study) parents aged ≥18 who have children aged 4-10 years will be eligible for SPARKLE. INTERVENTION AND COMPARATOR Parent Positive: is a digital public health intervention that can be delivered rapidly at scale to support parents in managing their children's behaviour to reduce conduct problems and levels of family conflict, which were exacerbated during the first lockdown, and which may increase further in future months as families need to cope with continuous uncertainty and further disruption to their daily lives. Co-designed with parents and based on decades of parenting research, Parent Positive consists of three elements: (i) Parenting Boosters: where advice, delivered in the form of narrated animations, videos, graphics and text is provided to help parents with eight common parenting challenges; (ii) Parenting Exchange: a facilitated parent-to-parent communication and peer support platform and; (iii) Parent Resources: giving access to carefully selected high-quality, evidence-based online parenting resources. Follow-up as Usual: FAU was selected as a comparator because the public health nature meant that an active comparator was not appropriate due to the pragmatic, rapid implementation of the trial. Individuals randomised to FAU will receive no intervention for the first two months while the data for baseline (T1), T2 and T3 are collected. They will then be given full access to the app until 30th November 2021. MAIN OUTCOMES Outcome measures will be collected remotely through Qualtrics according to the Co-SPACE schedule at baseline (T1), which will be the Co-SPACE survey data obtained immediately prior to randomisation, and then at one month (T2) and two months (T3) post-randomisation. Measures will be collected to assess group differences in child and parent outcomes, costs and service utilisation, and adverse events. Usage of Parent Positive will also be tracked. The primary outcome is parent-reported child conduct problems at one-month post-randomisation measured using the Strengths and Difficulties Questionnaire conduct problems subscale. RANDOMISATION Enrolled participants will be allocated to Parent Positive or FAU at the ratio of 1:1 by simple randomisation using the Randomizer function within the Qualtrics programme. Neither blocking nor stratification will be used. BLINDING (MASKING) It is not possible to blind parents enrolled in the study and Qualtrics will automatically inform parents of their group allocation. Blinded members of the research team and the senior statistician will not be given access to the Qualtrics system or the data in order to remain blinded until after the analysis is complete. We do not anticipate any serious harms associated with taking part in the intervention, therefore there will be no need to unblind any blinded staff during the study. The junior statistician will be unblinded throughout. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) A total of 616 will be recruited into the trial with 308 consenting parents randomised to each treatment arm. TRIAL STATUS V1.0; 15.03.2021. Not yet recruiting. Anticipated start date: 1 st April 2021. Anticipated end date for recruitment: 31 st July 2021. TRIAL REGISTRATION Clinicaltrial.gov: NCT04786080 . The trial was prospectively registered on 8 March 2021. FULL PROTOCOL The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).",2021,"Parent Positive: is a digital public health intervention that can be delivered rapidly at scale to support parents in managing their children's behaviour to reduce conduct problems and levels of family conflict, which were exacerbated during the first lockdown, and which may increase further in future months as families need to cope with continuous uncertainty and further disruption to their daily lives.","['A total of 616 will be recruited into the trial with 308 consenting parents randomised to each treatment arm', ""families' mental health since early lockdown (Co-SPACE"", 'parents aged ≥18 who have children aged 4-10 years will be eligible for SPARKLE', 'Co-SPACE (a UK-wide longitudinal cohort study', 'Supporting Parents & Kids Through Lockdown Experiences (SPARKLE']","['FAU', 'eight common parenting challenges; (ii) Parenting Exchange: a facilitated parent-to-parent communication and peer support platform and; (iii']","['child and parent outcomes, costs and service utilisation, and adverse events', 'collected remotely through Qualtrics according to the Co-SPACE schedule at baseline (T1), which will be the Co-SPACE survey data obtained immediately prior to randomisation', 'parent-reported child conduct problems at one-month post-randomisation measured using the Strengths and Difficulties Questionnaire conduct problems subscale']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0080636', 'cui_str': ""2'-fluoro-5-ethylarabinosyluracil""}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}]",308.0,0.320807,"Parent Positive: is a digital public health intervention that can be delivered rapidly at scale to support parents in managing their children's behaviour to reduce conduct problems and levels of family conflict, which were exacerbated during the first lockdown, and which may increase further in future months as families need to cope with continuous uncertainty and further disruption to their daily lives.","[{'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Kostyrka-Allchorne', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Creswell', 'Affiliation': 'Departments of Psychiatry and Experimental Psychology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Byford', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Crispin', 'Initials': 'C', 'LastName': 'Day', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Goldsmith', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Koch', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Walter Muruet', 'Initials': 'WM', 'LastName': 'Gutierrez', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Palmer', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Raw', 'Affiliation': 'Departments of Psychiatry and Experimental Psychology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Olly', 'Initials': 'O', 'LastName': 'Robertson', 'Affiliation': 'Departments of Psychiatry and Experimental Psychology, University of Oxford, Oxford, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Shearer', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Shum', 'Affiliation': 'Departments of Psychiatry and Experimental Psychology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Slovak', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Polly', 'Initials': 'P', 'LastName': 'Waite', 'Affiliation': 'Departments of Psychiatry and Experimental Psychology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Edmund J S', 'Initials': 'EJS', 'LastName': 'Sonuga-Barke', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK. edmund.sonuga-barke@kcl.ac.uk.""}]",Trials,['10.1186/s13063-021-05226-4'] 3291,33844469,"Temozolomide with irinotecan versus temozolomide, irinotecan plus bevacizumab for recurrent medulloblastoma of childhood: Report of a COG randomized Phase II screening trial.","BACKGROUND Approximately 30% of children with medulloblastoma (MB) experience recurrence, which is usually incurable. This study compared the overall survival (OS) of patients receiving temozolomide (TMZ) and irinotecan with that of patients receiving TMZ, irinotecan, and bevacizumab for recurrent MB/central nervous system (CNS) primitive neuroectodermal tumor (PNET). METHODS Patients with relapsed/refractory MB or CNS PNET were randomly assigned to receive TMZ (150 mg/m 2 /day PO on days 1-5) and irinotecan (50 mg/m 2 /day IV on days 1-5) with or without bevacizumab (10 mg/kg IV on days 1 and 15). RESULTS One hundred five patients were eligible and treated on study. Median OS was 13 months in the standard arm and 19 months with the addition of bevacizumab; median event-free survival (EFS) was 6 months in the standard arm and 9 months with the addition of bevacizumab. The hazard ratio for death from the stratified relative-risk regression model is 0.63. Overall, 23 patients completed 12 courses of planned protocol therapy, 23% (12/52) in the experimental arm with bevacizumab versus 21% (11/53) in the standard arm. Toxicity profiles were comparable in both treatment arms. The estimate of the incidence of feasibility events associated with the bevacizumab arm is three of 52 (5.8%) (95% CI 1.2-16%). Events included myelosuppression, electrolyte abnormalities, diarrhea, and elevated transaminases. One intracranial hemorrhage event was observed in each arm. CONCLUSION The addition of bevacizumab to TMZ/irinotecan significantly reduced the risk of death in children with recurrent MB. The combination was relatively well tolerated in this heavily pretreated cohort. The three-drug regimen demonstrated a sufficient risk reduction to warrant further investigation.",2021,The addition of bevacizumab to TMZ/irinotecan significantly reduced the risk of death in children with recurrent MB.,"['One hundred five patients were eligible and treated on study', 'Patients with relapsed/refractory MB or CNS PNET', '23 patients completed 12 courses of planned protocol therapy, 23% (12/52) in the experimental arm with', 'recurrent medulloblastoma of childhood', 'children with recurrent MB', 'for recurrent MB/central nervous system (CNS) primitive neuroectodermal tumor (PNET', 'children with medulloblastoma (MB) experience recurrence']","['TMZ', 'temozolomide (TMZ) and irinotecan', 'bevacizumab to TMZ/irinotecan', 'bevacizumab', 'TMZ, irinotecan, and bevacizumab', 'irinotecan', 'Temozolomide with irinotecan versus temozolomide, irinotecan plus bevacizumab']","['Toxicity profiles', 'risk of death', 'median event-free survival (EFS', 'intracranial hemorrhage event', 'Median OS', 'myelosuppression, electrolyte abnormalities, diarrhea, and elevated transaminases', 'hazard ratio for death', 'overall survival (OS']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0025149', 'cui_str': 'Medulloblastoma'}, {'cui': 'C3887678', 'cui_str': 'Central primitive neuroectodermal tumor'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0206663', 'cui_str': 'Primitive neuroectodermal tumor'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]","[{'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression'}, {'cui': 'C0151613', 'cui_str': 'Electrolytes abnormal'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0438717', 'cui_str': 'Transaminases increased'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",105.0,0.12621,The addition of bevacizumab to TMZ/irinotecan significantly reduced the risk of death in children with recurrent MB.,"[{'ForeName': 'Adam S', 'Initials': 'AS', 'LastName': 'Levy', 'Affiliation': ""Albert Einstein College of Medicine, Children's Hospital at Montefiore, Bronx, New York, USA.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Krailo', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Chi', 'Affiliation': 'Dana-Farber/Harvard Cancer Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Doojduen', 'Initials': 'D', 'LastName': 'Villaluna', 'Affiliation': ""Children's Oncology Group, Monrovia, California, USA.""}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Springer', 'Affiliation': ""Children's Oncology Group, Monrovia, California, USA.""}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Williams-Hughes', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Fouladi', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}, {'ForeName': 'Amar', 'Initials': 'A', 'LastName': 'Gajjar', 'Affiliation': ""Saint Jude Children's Research Hospital, Memphis, Tennessee, USA.""}]",Pediatric blood & cancer,['10.1002/pbc.29031'] 3292,33844449,Effect of atorvastatin on knee cartilage volume in patients with symptomatic knee osteoarthritis: results from a randomised placebo-controlled trial.,"OBJECTIVE To determine whether atorvastatin compared to placebo slows tibial cartilage volume loss in patients with symptomatic knee osteoarthritis in a multicentre, randomised, double-blind, placebo-controlled trial. METHODS Participants aged 40-70 years were randomised to oral atorvastatin 40 mg (n=151) or matching placebo (n=153) once daily. Primary endpoint: annual percentage change in tibial cartilage volume assessed using magnetic resonance imaging (MRI) over two years. Pre-specified secondary endpoints: progression of cartilage defects and bone marrow lesions assessed using MRI, and change in Western Ontario and McMaster Universities Osteoarthritis Index pain, stiffness and function over two years. RESULTS Of 304 participants (mean age 55.7 years, 55.6% female), 248 (81.6%) completed the trial. Annual change in tibial cartilage volume differed minimally between the atorvastatin and placebo groups (-1.66% vs. -2.17%, difference 0.50%, 95%CI -0.17% to 1.17%). There were no significant differences in progression of cartilage defects (odds ratio 0.86, 95%CI 0.52-1.41) or bone marrow lesions (odds ratio 1.00, 95%CI 0.62-1.63), change in pain [-36.0 vs. -29.5, adjusted difference -2.7, 95%CI -27.1 to 21.7), stiffness (-14.2 vs. -11.8, adjusted difference -0.2, 95%CI -12.2 to 11.8), or function [-89.4 vs. -87.5, adjusted difference 0.3, 95%CI -83.1 to 83.6). Incidence of adverse events was similar in atorvastatin (n=57, 37.7%) and placebo (n=52, 34.0%) groups. CONCLUSION Oral atorvastatin 40 mg once daily, compared with placebo, did not significantly reduce cartilage volume loss over two years in patients with symptomatic knee osteoarthritis. These findings do not support use of atorvastatin in the treatment of knee osteoarthritis.",2021,"Oral atorvastatin 40 mg once daily, compared with placebo, did not significantly reduce cartilage volume loss over two years in patients with symptomatic knee osteoarthritis.","['304 participants', 'patients with symptomatic knee osteoarthritis', 'Participants aged 40-70 years', 'mean age 55.7 years, 55.6% female), 248 (81.6%) completed the trial']","['atorvastatin', 'placebo', 'Oral atorvastatin', 'oral atorvastatin 40 mg (n=151) or matching placebo']","['Incidence of adverse events', 'cartilage defects and bone marrow lesions assessed using MRI, and change in Western Ontario and McMaster Universities Osteoarthritis Index pain, stiffness and function over two years', 'knee cartilage volume', 'change in pain', 'tibial cartilage volume', 'progression of cartilage defects', 'bone marrow lesions', 'tibial cartilage volume loss', 'cartilage volume loss', 'tibial cartilage volume assessed using magnetic resonance imaging (MRI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1616508', 'cui_str': 'atorvastatin 40 MG [Lipitor]'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",304.0,0.746996,"Oral atorvastatin 40 mg once daily, compared with placebo, did not significantly reduce cartilage volume loss over two years in patients with symptomatic knee osteoarthritis.","[{'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Jones', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS, 7000, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hill', 'Affiliation': 'The Queen Elizabeth Hospital, University of Adelaide, Woodville, SA, 5011, Australia.'}, {'ForeName': 'Anita E', 'Initials': 'AE', 'LastName': 'Wluka', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Forbes', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Tonkin', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Sultana Monira', 'Initials': 'SM', 'LastName': 'Hussain', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Changhai', 'Initials': 'C', 'LastName': 'Ding', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS, 7000, Australia.'}, {'ForeName': 'Flavia M', 'Initials': 'FM', 'LastName': 'Cicuttini', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, 3004, Australia.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41760'] 3293,33499197,Subjective Effects of Inhaling Kuromoji Tea Aroma.,"Teas and various herbal teas are well-known beverages and are commonly consumed around the world. In this study, we focused on kuromoji tea. Kuromoji is a deciduous shrub of the Lauraceae family, and the plucked leaves and branches have been drunk as a tea in production areas for a long time. However, no studies have investigated the subjective and physiological effects of kuromoji tea. In this study, the effects of kuromoji tea were examined on the basis of the measurements of heart rate variability and cerebral blood flow, core body temperature and subjective assessments. Moreover, the results of this study showed that a pleasant subjective feeling could be obtained by sniffing the aroma of kuromoji teas, especially tea leaves. It was also found that the aroma of kuromoji teas has the potential to stimulate saliva secretion and increase subjective and physiological excitements in the oral cavity. 1,8-Cineole, linalool, terpinen-4-ol, carvone and geraniol were determined in both kuromoji leaves and branches. In this study, the beneficial effects of kuromoji teas when drunk conventionally were investigated.",2021,"Moreover, the results of this study showed that a pleasant subjective feeling could be obtained by sniffing the aroma of kuromoji teas, especially tea leaves.",[],"['kuromoji tea', 'Inhaling Kuromoji Tea Aroma']","['1,8-Cineole, linalool, terpinen-4-ol, carvone and geraniol', 'heart rate variability and cerebral blood flow, core body temperature and subjective assessments', 'pleasant subjective feeling']",[],"[{'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C2987717', 'cui_str': 'Scents'}]","[{'cui': 'C0055738', 'cui_str': 'Eucalyptol'}, {'cui': 'C0064997', 'cui_str': 'Linalool'}, {'cui': 'C0076129', 'cui_str': 'terpinenol-4'}, {'cui': 'C0054837', 'cui_str': 'carvone'}, {'cui': 'C0061223', 'cui_str': 'geraniol'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0456240', 'cui_str': 'Core body temperature'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}]",,0.0191665,"Moreover, the results of this study showed that a pleasant subjective feeling could be obtained by sniffing the aroma of kuromoji teas, especially tea leaves.","[{'ForeName': 'Eri', 'Initials': 'E', 'LastName': 'Matsubara', 'Affiliation': 'Forestry and Forest Products Research Institute, 1 Matsunosato, Tsukuba, Ibaraki 305-8687, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Morikawa', 'Affiliation': 'Forestry and Forest Products Research Institute, 1 Matsunosato, Tsukuba, Ibaraki 305-8687, Japan.'}, {'ForeName': 'Norihisa', 'Initials': 'N', 'LastName': 'Kusumoto', 'Affiliation': 'Forestry and Forest Products Research Institute, 1 Matsunosato, Tsukuba, Ibaraki 305-8687, Japan.'}, {'ForeName': 'Koh', 'Initials': 'K', 'LastName': 'Hashida', 'Affiliation': 'Forestry and Forest Products Research Institute, 1 Matsunosato, Tsukuba, Ibaraki 305-8687, Japan.'}, {'ForeName': 'Naoyuki', 'Initials': 'N', 'LastName': 'Matsui', 'Affiliation': 'Forestry and Forest Products Research Institute, 1 Matsunosato, Tsukuba, Ibaraki 305-8687, Japan.'}, {'ForeName': 'Tatsuro', 'Initials': 'T', 'LastName': 'Ohira', 'Affiliation': 'Forestry and Forest Products Research Institute, 1 Matsunosato, Tsukuba, Ibaraki 305-8687, Japan.'}]","Molecules (Basel, Switzerland)",['10.3390/molecules26030575'] 3294,33844435,Promoting mother-infant relationships and underlying neural correlates: Results from a randomized controlled trial of a home-visiting program for adolescent mothers in Brazil.,"Poverty and teenage pregnancy are common in low-and-middle-income countries and can impede the development of healthy parent-child relationships. This study aimed to test whether a home-visiting intervention could improve early attachment relationships between adolescent mothers and their infants living in poverty in Brazil. Analyses were conducted on secondary outcomes from a randomized controlled trial (NCT0280718) testing the efficacy of a home-visiting program, Primeiros Laços, on adolescent mothers' health and parenting skills and their infants' development. Pregnant youth were randomized to intervention (n = 40) or care-as-usual (CAU, n = 40) from the first trimester of pregnancy until infants were aged 24 months. Mother-infant attachment was coded during a mother-infant interaction when the infants were aged 12 months. Electrophysiological correlates of social processing (mean amplitude of the Nc component) were measured while infants viewed facial images of the mother and a stranger at age 6 months. Infants in the intervention group were more securely attached and more involved with their mothers than those receiving CAU at 12 months. Smaller Nc amplitudes to the mother's face at 6 months were associated with better social behavior at 12 months. Our findings indicate that the Primeiros Laços Program is effective in enhancing the development of mother-infant attachment.",2021,Infants in the intervention group were more securely attached and more involved with their mothers than those receiving CAU at 12 months.,"['adolescent mothers in Brazil', 'adolescent mothers and their infants living in poverty in Brazil', ""adolescent mothers' health and parenting skills and their infants' development"", 'Pregnant youth']","['home-visiting program', 'home-visiting program, Primeiros Laços', 'home-visiting intervention', 'care-as-usual (CAU']","['early attachment relationships', 'social behavior', 'Electrophysiological correlates of social processing (mean amplitude of the Nc component']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444892', 'cui_str': 'CAU'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0037397', 'cui_str': 'Social behavior'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",40.0,0.0412429,Infants in the intervention group were more securely attached and more involved with their mothers than those receiving CAU at 12 months.,"[{'ForeName': 'Fernanda Speggiorin Pereira', 'Initials': 'FSP', 'LastName': 'Alarcão', 'Affiliation': 'Department of Psychiatry, Faculdade de Medicina FMUSP, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Shephard', 'Affiliation': 'Department of Psychiatry, Faculdade de Medicina FMUSP, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Fatori', 'Affiliation': 'Department of Psychiatry, Faculdade de Medicina FMUSP, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Amável', 'Affiliation': 'Department of Psychiatry, Faculdade de Medicina FMUSP, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Chiesa', 'Affiliation': 'School of Nursing, Faculdade de Medicina FMUSP, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Lislaine', 'Initials': 'L', 'LastName': 'Fracolli', 'Affiliation': 'School of Nursing, Faculdade de Medicina FMUSP, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Matijasevich', 'Affiliation': 'Department of Preventive Medicine, Faculdade de Medicina FMUSP, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Brentani', 'Affiliation': 'Department of Psychiatry, Faculdade de Medicina FMUSP, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Nelson', 'Affiliation': ""Laboratories of Cognitive Neuroscience, Division of Developmental Medicine, Boston Children's Hospital, Harvard Medical School, Boston, USA.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Leckman', 'Affiliation': 'Yale Child Study Center, Yale University School of Medicine, New Haven, USA.'}, {'ForeName': 'Eurípedes Constantino', 'Initials': 'EC', 'LastName': 'Miguel', 'Affiliation': 'Department of Psychiatry, Faculdade de Medicina FMUSP, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Guilherme V', 'Initials': 'GV', 'LastName': 'Polanczyk', 'Affiliation': 'Department of Psychiatry, Faculdade de Medicina FMUSP, Universidade de São Paulo, São Paulo, SP, Brazil.'}]",Developmental science,['10.1111/desc.13113'] 3295,33844425,Effectiveness of Theory-Based Health Information Technology Interventions on Coronary Artery Disease Self-Management Behavior: A Clinical Randomized Waitlist-Controlled Trial.,"PURPOSE Secondary prevention of coronary artery disease, self-management behavior, and blood pressure control are important to cardiovascular event prevention and promotion of quality of life (QOL), but they are underutilized. The purpose of this study was to investigate the effects of a self-efficacy theory-based health information technology intervention implemented through blood control and patient self-management. DESIGN A clinical randomized waitlist-controlled trial. METHODS The study was conducted at a medical center in Taipei, Taiwan. A total of 60 subjects were randomly assigned to either the immediate intervention (experimental) group or the waitlist control group. The primary endpoint was systolic blood pressure at 3 months; secondary end points included self-management behavior and QOL. Treatment for the immediate intervention group lasted 3 months, while the waitlist control group received routine care for the first 3 months, at which point they crossed over to the intervention arm and received the same intervention as the experimental group for another 3 months. Both groups were evaluated by questionnaires and physiological measurements at both 3 and 6 months postadmission. The results were analyzed using generalized estimating equations. RESULTS Systolic blood pressure significantly improved for the intervention group participants at 3 months, when there was also significant improvement in self-management behavior and QOL. There was no significant or appreciable effect of time spent in the waitlist condition, with treatments in the two conditions being similarly effective. CONCLUSION The use of a theory-based health information technology treatment compared with usual care resulted in a significant improvement in systolic blood pressure, self-management behavior, and QOL in patients with coronary artery disease. CLINICAL RELEVANCE This treatment would be a useful strategy for clinical care of cardiovascular disease patients, improving their disease self-management. It also may help guide further digital health care strategies during the COVID-19 pandemic.",2021,A total of 60 subjects were randomly assigned to either the immediate intervention (experimental) group or the waitlist control group.,"['Coronary Artery Disease Self-Management Behavior', 'patients with coronary artery disease', '60 subjects', 'medical center in Taipei, Taiwan']","['Theory-Based Health Information Technology Interventions', 'self-efficacy theory-based health information technology intervention', 'immediate intervention (experimental) group or the waitlist control group', 'waitlist control group received routine care']","['Systolic blood pressure', 'time spent', 'quality of life (QOL', 'systolic blood pressure', 'systolic blood pressure, self-management behavior, and QOL', 'self-management behavior and QOL']","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2936756', 'cui_str': 'Health Information Technology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",60.0,0.00540288,A total of 60 subjects were randomly assigned to either the immediate intervention (experimental) group or the waitlist control group.,"[{'ForeName': 'Pei-Chen', 'Initials': 'PC', 'LastName': 'Hong', 'Affiliation': 'School of Nursing, National Defense Medical Center, Taipei, and Lecturer, Yuh-Ing Junior College of Health Care & Management, Kaohsiung, Taiwan.'}, {'ForeName': 'Kuan-Jung', 'Initials': 'KJ', 'LastName': 'Chen', 'Affiliation': 'Lambda Beta-at-large, Assistant Head Nurse, Department of Nursing, Tri-Service General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Yue-Cune', 'Initials': 'YC', 'LastName': 'Chang', 'Affiliation': 'Professor, Department of Mathematics, Tamkang University, Taipei, Taiwan.'}, {'ForeName': 'Shu-Meng', 'Initials': 'SM', 'LastName': 'Cheng', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Tri-Service General Hospital and Professor, School of Medicine, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Hui-Hsun', 'Initials': 'HH', 'LastName': 'Chiang', 'Affiliation': 'Lambda Beta-at-large, Associate Professor, School of Nursing, National Defense Medical Center, Taipei, Taiwan.'}]",Journal of nursing scholarship : an official publication of Sigma Theta Tau International Honor Society of Nursing,['10.1111/jnu.12661'] 3296,33844409,Cosmetic outcomes following wide local excision of impalpable breast cancer: is radioguided occult lesion localization using iodine-125 seeds better than hookwire localization?,"BACKGROUND Hookwire localization (HWL) is the gold standard for localizing impalpable tumours for breast conserving surgery. An alternative technique, radioguided occult lesion localization using iodine-125 seeds (ROLLIS), has been associated with lower re-excision rates. This paper investigates if cosmetic outcomes differ in women undergoing breast conserving surgery with HWL or ROLLIS. METHODS Women who had ROLLIS or HWL guided excision for impalpable breast cancer within a multicentre randomized controlled trial (RCT) (ANZCTR 12613000655741) were recruited. Exclusions were level 2 oncoplasty and mastectomy. Cosmetic outcome was calculated using BCCT.core, the Hopwood Body Image Scale and estimated percentage breast volume excised. Chi-squared analysis was used to determine the difference between the intervention groups. RESULTS Analysis was performed for 123 participants (66 ROLLIS and 57 HWL). The cosmetic outcome determined by BCCT.core for all participants was good with no significant difference between the ROLLIS and HWL groups. When reviewing the number of patients who experienced either a good or excellent result, there was a significantly higher number of patients in the ROLLIS group (n = 53, 82%) compared to the HWL group (n = 42, 74%, P = 0.02. There were no differences in Hopwood Body Image Scale or estimated percentage breast volume excised between groups. There was a reduction in the frequency of re-excision in the ROLLIS group (n = 3, 4.5%) versus HWL group (n = 8, 14%); however, this was not significant (P = 0.06). CONCLUSION Pre-operative localization of impalpable breast lesions using either ROLLIS or HWL resulted in a good cosmetic outcome with no significant difference between localization techniques.",2021,Pre-operative localization of impalpable breast lesions using either ROLLIS or HWL resulted in a good cosmetic outcome with no significant difference between localization techniques.,"['women undergoing breast conserving surgery with HWL or ROLLIS', 'Women who had ROLLIS or HWL guided excision for impalpable breast cancer within a multicentre randomized controlled trial (RCT) (ANZCTR 12613000655741) were recruited', 'impalpable breast cancer', '123 participants (66 ROLLIS and 57 HWL']","['iodine-125 seeds (ROLLIS', 'wide local excision', 'ROLLIS or HWL']","['frequency of re-excision', 'cosmetic outcome determined by BCCT.core', 'Cosmetic outcome', 'Hopwood Body Image Scale']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C0037710', 'cui_str': 'Auditory localization'}, {'cui': 'C0028794', 'cui_str': 'Occultism'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0796396', 'cui_str': 'Iodine-125'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0796396', 'cui_str': 'Iodine-125'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0028794', 'cui_str': 'Occultism'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0037710', 'cui_str': 'Auditory localization'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0278259', 'cui_str': 'Local excision'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0184913', 'cui_str': 'Reexcision'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0801028,Pre-operative localization of impalpable breast lesions using either ROLLIS or HWL resulted in a good cosmetic outcome with no significant difference between localization techniques.,"[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Preuss', 'Affiliation': 'Department of Anaesthesia, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Rikki', 'Initials': 'R', 'LastName': 'Nezich', 'Affiliation': 'School of Physics, University of Western Australia, Crawley, Perth, Western Australia, Australia.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Lester', 'Affiliation': 'Department of Sports Science Exercise and Health, School of Human Sciences, The University of Western Australia, Crawley, Perth, Western Australia, Australia.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Poh', 'Affiliation': 'School of Medicine, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Christobel', 'Initials': 'C', 'LastName': 'Saunders', 'Affiliation': 'Division of Surgery, Medical School, University of Western Australia, Crawley, Perth, Western Australia, Australia.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Taylor', 'Affiliation': 'Division of Surgery, Medical School, University of Western Australia, Crawley, Perth, Western Australia, Australia.'}]",ANZ journal of surgery,['10.1111/ans.16756'] 3297,33844408,Epigastric symptom response to low FODMAP dietary advice compared with standard dietetic advice in individuals with functional dyspepsia.,"BACKGROUND Certain dietary constituents may provoke symptoms of functional dyspepsia (FD); however, there is an absence of dietary trials testing specific dietary interventions. Empirically derived dietary strategies and the low FODMAP diet are frequently used in practice. This study aimed to compare the effectiveness of low FODMAP dietary advice with standard dietary advice for reducing epigastric and overall gastrointestinal symptoms in individuals with FD. METHODS Data were collected from 59 consecutive eligible individuals with FD attending an initial and review outpatient dietetic consultation at Princess Alexandra Hospital. Of these, 40 received low FODMAP advice and 19 received standard dietary advice. As part of usual care, the Structured Assessment of Gastrointestinal Symptom Scale (SAGIS) was used to assess epigastric (maximum score = 28) and overall gastrointestinal symptoms (maximum score = 88). Dietary adherence data were collected, and change in symptom score and proportion of responders (defined as a ≥30% reduction in score) for epigastric and total symptoms was calculated. KEY RESULTS Most individuals (48/59, 81%) had FD and coexisting irritable bowel syndrome. There was a greater reduction in epigastric score in those receiving low FODMAP dietary advice compared with those receiving standard advice (est. marginal mean [95% CI]: -3.6 [-4.9, -2.2] vs. -0.9 [-2.9, 1.1], p = 0.032) and total symptom score (-9.4 [-12.4, -6.4] vs. -3.3 [-7.7, 1.1] p = 0.026). A greater proportion receiving low FODMAP dietary advice were responders versus those receiving standard advice (50% vs. 16%, p = 0.012). Dietary adherence did not differ between groups (p = 0.497). CONCLUSIONS & INFERENCES The low FODMAP diet appears more effective for improving epigastric symptoms in people with FD compared with standard advice. A randomized controlled trial is required to substantiate these findings.",2021,The low FODMAP diet appears more effective for improving epigastric symptoms in people with FD compared with standard advice.,"['individuals with functional dyspepsia', 'individuals with FD', '59 consecutive eligible individuals with FD attending an initial and review outpatient dietetic consultation at Princess Alexandra Hospital']","['low FODMAP dietary advice with standard dietary advice', 'low FODMAP dietary advice', 'standard dietetic advice', 'low FODMAP advice and 19 received standard dietary advice']","['Epigastric symptom response', 'Dietary adherence', 'epigastric and total symptoms', 'epigastric and overall gastrointestinal symptoms', 'FD and coexisting irritable bowel syndrome', 'epigastric score', 'total symptom score', 'Gastrointestinal Symptom Scale (SAGIS', 'overall gastrointestinal symptoms', 'Dietary adherence data', 'epigastric symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0012180', 'cui_str': 'Dietetics'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0012180', 'cui_str': 'Dietetics'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0401706,The low FODMAP diet appears more effective for improving epigastric symptoms in people with FD compared with standard advice.,"[{'ForeName': 'Heidi M', 'Initials': 'HM', 'LastName': 'Staudacher', 'Affiliation': 'Department of Nutrition and Dietetics, Princess Alexandra Hospital, Brisbane, Qld, Australia.'}, {'ForeName': 'Amy N', 'Initials': 'AN', 'LastName': 'Nevin', 'Affiliation': 'Department of Nutrition and Dietetics, Princess Alexandra Hospital, Brisbane, Qld, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Duff', 'Affiliation': 'Department of Nutrition and Dietetics, Princess Alexandra Hospital, Brisbane, Qld, Australia.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Kendall', 'Affiliation': 'Department of Gastroenterology and Hepatology, Princess Alexandra Hospital, Brisbane, Qld, Australia.'}, {'ForeName': 'Gerald J', 'Initials': 'GJ', 'LastName': 'Holtmann', 'Affiliation': 'Department of Gastroenterology and Hepatology, Princess Alexandra Hospital, Brisbane, Qld, Australia.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.14148'] 3298,33844262,Comparison of the effects of tens stimulation and water immersion on relieving labour pain suffered byprimiparas.,"OBJECTIVES The aim of this study was to compare pain suffered by primiparas when delivering a child in a traditional way with deliveries where either TENS stimulation or water immersion was used. MATERIAL AND METHODS Primiparas were divided into 3 groups. In group 1 there were 45 women for whom TENS stimulation was applied during delivery. Group 2 consisted of 38 women who remained in the water during the actual birth of the baby. Group 3 served as the control group and was composed of 32 women. The intensity of pain during delivery was assessed by means of a numerical scale. During the first delivery period, pain was assessed three times at cervical dilation of 2, 3 and 4 fingers. RESULTS The analysis of pain suffered by primiparas at 2-finger widening showed no statistically significant differences between the groups. However, the analysis of pain experienced at 3-finger opening showed significant differences between the group of women using TENS stimulation in comparison with the control group. When comparing pain at 4-finger opening, statistically significant differences were found between the group of women who delivered in water in comparison to both the control group and the group using TENS stimulation. CONCLUSIONS TENS stimulation and water immersion are good methods to relieve labour pain; particularly helpful in the first period of labour. They are also safe, alternative, non-pharmacological methods of reducing labour pain.",2021,The analysis of pain suffered by primiparas at 2-finger widening showed no statistically significant differences between the groups.,"['labour pain suffered byprimiparas', '38 women who remained in the water during the actual birth of the baby', 'Primiparas were divided into 3 groups', 'pain suffered by primiparas when delivering a child in a traditional way with deliveries where either']","['TENS stimulation or water immersion', 'stimulation and water immersion']","['labour pain', 'intensity of pain during delivery']","[{'cui': 'C0474368', 'cui_str': 'Labor pain'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]","[{'cui': 'C0014518', 'cui_str': 'Lyell syndrome'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}]","[{'cui': 'C0474368', 'cui_str': 'Labor pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]",45.0,0.0224602,The analysis of pain suffered by primiparas at 2-finger widening showed no statistically significant differences between the groups.,"[{'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Grymel-Kulesza', 'Affiliation': 'Gdansk Collage of Health, Poland.'}, {'ForeName': 'Katarzyna M', 'Initials': 'KM', 'LastName': 'Pawlowska', 'Affiliation': 'Department of Physiotherapy and Wellness, Institute of Health Sciences, Pomeranian University in Slupsk, Poland. pawlowskakatarzyna@interia.eu.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Pawlowski', 'Affiliation': 'Department of Physiotherapy and Wellness, Institute of Health Sciences, Pomeranian University in Slupsk, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Grochulska', 'Affiliation': 'Department of Physiotherapy and Wellness, Institute of Health Sciences, Pomeranian University in Slupsk, Poland.'}, {'ForeName': 'Marcelina', 'Initials': 'M', 'LastName': 'Belkius', 'Affiliation': 'Praxis Physiotherapie Jeske, Berlin, Germany.'}, {'ForeName': 'Izabela', 'Initials': 'I', 'LastName': 'Jerzak', 'Affiliation': 'Department of Pharmacology and Toxicology, University of Zielona Gora, Collegium Medicum, Poland.'}]",Ginekologia polska,['10.5603/GP.a2021.0026'] 3299,33844258,The effect of various pressure of pneumatic uterine bracket by using saccule sterine external stent on incidence of supine hypotensive syndrome.,"OBJECTIVES The saccule uterine external stent with a pneumatic uterine bracket reportedly prevents the incidence of supine hypotension syndrome (SHS) during cesarean section under combined spinal - epidural anesthesia (CSEA). However, the preventive effect is affected by the pressure within pneumatic uterine bracket. This study aims to explore the optimal pressure. MATERIAL AND METHODS One hundred forty-eight pregnant women were selected and randomly divided into three groups: Group A (the control group, n = 49), Group B (n = 49), and Group C (n = 50). The pressure within pneumatic uterine bracket was set at 240 mmHg, 260mmHg, and 280mmHg, respectively, during cesarean section under CSEA for participants in groups A, B and C. The intraoperative comfort rate and incidence of SHS were recorded. RESULTS No significant difference in the anesthetic efficacy was observed among the three groups (p > 0.05). However, there was a significant difference in the occurrence of SHS, with a reduction of 30 mmHg in blood pressure. The incidence of SHS belong the three groups showed significant differences (36.73% in Group A, 18.37% in Group B and 18.00% in Group C, p < 0.05). In addition, significant differences (p < 0.05) in the intraoperative comfort rate were also found among the three groups, with the comfort rate of 69.39% in group A, 91.84% in group B and 90.00% in Group C. CONCLUSIONS The optimal pressure within pneumatic uterine bracket for preventing SHS hypotension is about 260 mmHg. These findings might contribute to the prevention of SHS.",2021,"In addition, significant differences (p < 0.05) in the intraoperative comfort rate were also found among the three groups, with the comfort rate of 69.39% in group A, 91.84% in group B and 90.00% in Group C. ",['One hundred forty-eight pregnant women'],"['pneumatic uterine bracket', 'saccule sterine external stent', 'cesarean section under combined spinal - epidural anesthesia (CSEA']","['anesthetic efficacy', 'blood pressure', 'supine hypotension syndrome (SHS', 'intraoperative comfort rate', 'intraoperative comfort rate and incidence of SHS', 'incidence of supine hypotensive syndrome', 'incidence of SHS', 'occurrence of SHS', 'comfort rate']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0036029', 'cui_str': 'Saccule structure'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}]","[{'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C3267143', 'cui_str': 'Supine hypotension syndrome'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0341966', 'cui_str': 'Maternal hypotension syndrome'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",148.0,0.100706,"In addition, significant differences (p < 0.05) in the intraoperative comfort rate were also found among the three groups, with the comfort rate of 69.39% in group A, 91.84% in group B and 90.00% in Group C. ","[{'ForeName': 'Tianke', 'Initials': 'T', 'LastName': 'Xiao', 'Affiliation': 'Department of Anesthesiology, CNNC 416th Hospital, The Second Affiliated Hospital of Chengdu Medical College, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynecology, CNNC 416th Hospital, The Second Affiliated Hospital of Chengdu Medical College, China.'}, {'ForeName': 'Mingshuai', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, CNNC 416th Hospital, The Second Affiliated Hospital of Chengdu Medical College, China.'}, {'ForeName': 'Xuehui', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Obstetrics and Gynecology, CNNC 416th Hospital, The Second Affiliated Hospital of Chengdu Medical College, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, CNNC 416th Hospital, The Second Affiliated Hospital of Chengdu Medical College, China. drzhangke@126.com.'}, {'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynecology, CNNC 416th Hospital, The Second Affiliated Hospital of Chengdu Medical College, China.'}]",Ginekologia polska,['10.5603/GP.a2021.0009'] 3300,33844014,Visit-to-visit blood pressure variability and incident frailty in older adults.,"To determine whether visit-to-visit blood pressure (BP) variability (BPV) is associated with incident frailty. We included 1,394 non-frail community-dwelling participants aged ≥ 70 years from the Multidomain Alzheimer Preventive Trial (MAPT) who underwent repeated clinical examinations, including BP and frailty, over a 5-year follow-up period. Systolic BPV (SBPV), diastolic BPV (DBPV), mean arterial pressure variability (MAPV) and pulse pressure variability (PPV) were evaluated using standard deviation, coefficient of variation (CV), average real variability, successive variation, variation independent of mean and residual standard deviation. Incident frailty was assessed using the Fried phenotype. Cox proportional hazards models were used for the analyses. Higher SBPV was significantly associated with greater risk of frailty (1-sd increase of CV: HR = 1.18, 95% CI [1.02-1.36]) after adjustment for demographics, systolic BP, antihypertensive drugs, body mass index, diabetes, ischemic heart disease, congestive heart failure, stroke, atrial fibrillation, MAPT randomization group and frailty status. Similar results were observed with all indicators of variability. Higher PPV was associated with a greater risk of developing frailty over time (1-sd increase of CV: HR = 1.17, 95% CI [1.01-1.35]). DBPV and MAPV were not significantly associated with incident frailty. Higher SBPV and PPV were associated with greater risk of incident frailty. Our findings support the concept of BP physiological dysregulation underlying the frail state and suggest that BP instability could be an early marker of frailty.",2021,"Higher SBPV was significantly associated with greater risk of frailty (1-sd increase of CV: HR = 1.18, 95% CI [1.02-1.36]) after adjustment for demographics, systolic BP, antihypertensive drugs, body mass index, diabetes, ischemic heart disease, congestive heart failure, stroke, atrial fibrillation, MAPT randomization group and frailty status.","['older adults', '1,394 non-frail community-dwelling participants aged ≥ 70 years from the Multidomain Alzheimer Preventive Trial (MAPT) who underwent repeated clinical examinations, including BP and frailty, over a 5-year follow-up period']",[],"['standard deviation, coefficient of variation (CV), average real variability, successive variation, variation independent of mean and residual standard deviation', 'Systolic BPV (SBPV), diastolic BPV (DBPV), mean arterial pressure variability (MAPV) and pulse pressure variability (PPV', 'demographics, systolic BP, antihypertensive drugs, body mass index, diabetes, ischemic heart disease, congestive heart failure, stroke, atrial fibrillation', 'visit-to-visit blood pressure (BP) variability (BPV', 'DBPV and MAPV', 'risk of frailty', 'Incident frailty']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",[],"[{'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0332291', 'cui_str': 'Independent of'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0006072', 'cui_str': 'Bovine papillomavirus'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}]",1394.0,0.0725399,"Higher SBPV was significantly associated with greater risk of frailty (1-sd increase of CV: HR = 1.18, 95% CI [1.02-1.36]) after adjustment for demographics, systolic BP, antihypertensive drugs, body mass index, diabetes, ischemic heart disease, congestive heart failure, stroke, atrial fibrillation, MAPT randomization group and frailty status.","[{'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Rouch', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, CHU de Toulouse, France.'}, {'ForeName': 'Philipe', 'Initials': 'P', 'LastName': 'De Souto Barreto', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, CHU de Toulouse, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Hanon', 'Affiliation': 'EA 4468, Université Paris Descartes, Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Jean-Sébastien', 'Initials': 'JS', 'LastName': 'Vidal', 'Affiliation': 'EA 4468, Université Paris Descartes, Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Amar', 'Affiliation': 'Service de cardiologie, CHU de Toulouse, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Andrieu', 'Affiliation': 'UMR INSERM 1027, Université Toulouse III, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Cestac', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, CHU de Toulouse, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rolland', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, CHU de Toulouse, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vellas', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, CHU de Toulouse, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glab112'] 3301,33844007,Genetic and depressive traits moderate the reward-enhancing effects of acute nicotine in young light smokers.,"Rates of light smoking have increased in recent years and are associated with adverse health outcomes. Reducing light smoking is a challenge because it is unclear why some but not others, progress to heavier smoking. Nicotine has profound effects on brain reward systems and individual differences in nicotine's reward-enhancing effects may drive variability in smoking trajectories. Therefore, we examined whether a genetic risk factor and personality traits known to moderate reward processing, also moderate the reward-enhancing effects of nicotine. Light smokers (n=116) performed a Probabilistic Reward Task to assess reward responsiveness after receiving either nicotine or placebo (order counterbalanced). Individuals were classified as nicotine dependence 'risk' allele carriers (rs16969968 A-allele carriers) or non-carriers (non-A-allele carriers), and self-reported negative affective traits were also measured. Across the whole sample, reward responsiveness was greater following nicotine compared to placebo (p=0.045). For Caucasian A-allele carriers but not non-A-allele carriers, nicotine enhanced reward responsiveness compared to placebo for those who received the placebo first (p=0.010). Furthermore, for A-allele carriers but not non-A-allele carriers who received nicotine first, the enhanced reward responsiveness in the nicotine condition carried over to the placebo condition (p<0.001). Depressive traits also moderated the reward-enhancing effects of nicotine (p=0.010) and were associated with more blunted reward responsiveness following placebo but enhanced reward responsiveness following nicotine. These findings suggest that individual differences in a genetic risk factor and depressive traits alter nicotine's effect on reward responsiveness in light smokers and may be important factors underpinning variability in smoking trajectories in this growing population.",2021,"For Caucasian A-allele carriers but not non-A-allele carriers, nicotine enhanced reward responsiveness compared to placebo for those who received the placebo first (p=0.010).","['young light smokers', 'Light smokers (n=116']","['nicotine or placebo', 'nicotine', 'Probabilistic Reward Task', 'placebo', 'Nicotine']","['reward responsiveness', 'Depressive traits', 'Rates of light smoking']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C3494624', 'cui_str': 'Light tobacco smoker'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}]","[{'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}]",,0.13905,"For Caucasian A-allele carriers but not non-A-allele carriers, nicotine enhanced reward responsiveness compared to placebo for those who received the placebo first (p=0.010).","[{'ForeName': 'Alexis E', 'Initials': 'AE', 'LastName': 'Whitton', 'Affiliation': 'McLean Hospital & Harvard Medical School.'}, {'ForeName': 'Norka E', 'Initials': 'NE', 'LastName': 'Rabinovich', 'Affiliation': 'Department of Psychology, Southern Illinois University.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Lindt', 'Affiliation': 'Department of Psychology, Southern Illinois University.'}, {'ForeName': 'Michele L', 'Initials': 'ML', 'LastName': 'Pergadia', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine.'}, {'ForeName': 'Diego A', 'Initials': 'DA', 'LastName': 'Pizzagalli', 'Affiliation': 'McLean Hospital & Harvard Medical School.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Gilbert', 'Affiliation': 'Department of Psychology, Southern Illinois University.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntab072'] 3302,33843980,Individualized versus Fixed Positive End-expiratory Pressure for Intraoperative Mechanical Ventilation in Obese Patients: A Secondary Analysis.,"BACKGROUND General anesthesia may cause atelectasis and deterioration in oxygenation in obese patients. The authors hypothesized that individualized positive end-expiratory pressure (PEEP) improves intraoperative oxygenation and ventilation distribution compared to fixed PEEP. METHODS This secondary analysis included all obese patients recruited at University Hospital of Leipzig from the multicenter Protective Intraoperative Ventilation with Higher versus Lower Levels of Positive End-Expiratory Pressure in Obese Patients (PROBESE) trial (n = 42) and likewise all obese patients from a local single-center trial (n = 54). Inclusion criteria for both trials were elective laparoscopic abdominal surgery, body mass index greater than or equal to 35 kg/m2, and Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) score greater than or equal to 26. Patients were randomized to PEEP of 4 cm H2O (n = 19) or a recruitment maneuver followed by PEEP of 12 cm H2O (n = 21) in the PROBESE study. In the single-center study, they were randomized to PEEP of 5 cm H2O (n = 25) or a recruitment maneuver followed by individualized PEEP (n = 25) determined by electrical impedance tomography. Primary endpoint was Pao2/inspiratory oxygen fraction before extubation and secondary endpoints included intraoperative tidal volume distribution to dependent lung and driving pressure. RESULTS Ninety patients were evaluated in three groups after combining the two lower PEEP groups. Median individualized PEEP was 18 (interquartile range, 16 to 22; range, 10 to 26) cm H2O. Pao2/inspiratory oxygen fraction before extubation was 515 (individual PEEP), 370 (fixed PEEP of 12 cm H2O), and 305 (fixed PEEP of 4 to 5 cm H2O) mmHg (difference to individualized PEEP, 145; 95% CI, 91 to 200; P < 0.001 for fixed PEEP of 12 cm H2O and 210; 95% CI, 164 to 257; P < 0.001 for fixed PEEP of 4 to 5 cm H2O). Intraoperative tidal volume in the dependent lung areas was 43.9% (individualized PEEP), 25.9% (fixed PEEP of 12 cm H2O) and 26.8% (fixed PEEP of 4 to 5 cm H2O) (difference to individualized PEEP: 18.0%; 95% CI, 8.0 to 20.7; P < 0.001 for fixed PEEP of 12 cm H2O and 17.1%; 95% CI, 10.0 to 20.6; P < 0.001 for fixed PEEP of 4 to 5 cm H2O). Mean intraoperative driving pressure was 9.8 cm H2O (individualized PEEP), 14.4 cm H2O (fixed PEEP of 12 cm H2O), and 18.8 cm H2O (fixed PEEP of 4 to 5 cm H2O), P < 0.001. CONCLUSIONS This secondary analysis of obese patients undergoing laparoscopic surgery found better oxygenation, lower driving pressures, and redistribution of ventilation toward dependent lung areas measured by electrical impedance tomography using individualized PEEP. The impact on patient outcome remains unclear. EDITOR’S PERSPECTIVE ",2021,"mmHg (difference to individualized PEEP, 145; 95% CI, 91 to 200; P < 0.001 for fixed PEEP of 12 cm H2O and 210; 95% CI, 164 to 257; P < 0.001 for fixed PEEP of 4 to 5 cm H2O).","['Obese Patients', 'Ninety patients', 'Surgical Patients in Catalonia (ARISCAT) score greater than or equal to 26', 'obese patients', 'obese patients recruited at University Hospital of Leipzig from the multicenter Protective Intraoperative Ventilation with Higher versus Lower Levels of Positive End-Expiratory Pressure in Obese Patients (PROBESE) trial (n = 42) and likewise all obese patients from a local single-center trial (n = 54', 'obese patients undergoing']","['laparoscopic surgery', 'H2O. Pao2/inspiratory oxygen fraction before extubation was 515 (individual PEEP', 'Individualized versus Fixed Positive End-expiratory Pressure for Intraoperative Mechanical Ventilation', 'PEEP of 4 cm H2O (n = 19) or a recruitment maneuver followed by PEEP of 12 cm H2O', 'recruitment maneuver followed by individualized PEEP', 'individualized positive end-expiratory pressure (PEEP']","['better oxygenation, lower driving pressures, and redistribution of ventilation toward dependent lung areas', 'Mean intraoperative driving pressure', 'Intraoperative tidal volume', 'intraoperative tidal volume distribution to dependent lung and driving pressure', 'Pao2/inspiratory oxygen fraction before extubation', 'Median individualized PEEP', 'intraoperative oxygenation and ventilation distribution']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C1883551', 'cui_str': 'WATER, O-15'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0439476', 'cui_str': 'cmH2O'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0332620', 'cui_str': 'Redistribution'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}]",90.0,0.229145,"mmHg (difference to individualized PEEP, 145; 95% CI, 91 to 200; P < 0.001 for fixed PEEP of 12 cm H2O and 210; 95% CI, 164 to 257; P < 0.001 for fixed PEEP of 4 to 5 cm H2O).","[{'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Simon', 'Affiliation': ''}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Girrbach', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Petroff', 'Affiliation': ''}, {'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Schliewe', 'Affiliation': ''}, {'ForeName': 'Gunther', 'Initials': 'G', 'LastName': 'Hempel', 'Affiliation': ''}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Lange', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bluth', 'Affiliation': ''}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Gama de Abreu', 'Affiliation': ''}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Beda', 'Affiliation': ''}, {'ForeName': 'Marcus J', 'Initials': 'MJ', 'LastName': 'Schultz', 'Affiliation': ''}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pelosi', 'Affiliation': ''}, {'ForeName': 'Andreas W', 'Initials': 'AW', 'LastName': 'Reske', 'Affiliation': ''}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Wrigge', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003762'] 3303,33843948,Effects of a Self-directed Web-Based Strengthening Exercise and Physical Activity Program Supported by Automated Text Messages for People With Knee Osteoarthritis: A Randomized Clinical Trial.,"Importance Exercise therapies are advocated in osteoarthritis (OA) clinical guidelines. However, challenges to accessing exercise may be limiting widespread uptake. Objective To evaluate the effects of a self-directed web-based strengthening exercise and physical activity program supported by automated behavior-change text messages on knee pain and function for people with knee OA. Design, Setting, and Participants The participant-blinded and assessor-blinded randomized clinical trial enrolled 206 people who met clinical criteria for knee OA in communities across Australia from July 2018 to August 2019, with follow-up taking place at 24 weeks. Interventions The control group was given access to a custom-built website with information on OA and the importance of exercise and physical activity. The intervention group was given access to the same information plus a prescription for a 24-week self-directed strengthening regimen and guidance to increase physical activity, supported by automated behavior-change text messages encouraging exercise adherence. Main Outcomes and Measures Primary outcomes were change in overall knee pain (numeric rating scale, 0-10) and difficulty with physical function (Western Ontario and McMaster Universities Osteoarthritis Index, 0-68) over 24 weeks. Secondary outcomes were another knee pain measure, sport and recreation function, quality of life, physical activity, self-efficacy, overall improvement, and treatment satisfaction. Results Of 206 participants, 180 (87%; mean [SD] age, 60 [8.4] years; 109 [61%] women) completed both 24-week primary outcomes. The intervention group showed greater improvements in overall knee pain (mean difference, 1.6 units; 95% CI, 0.9-2.2 units; P < .001) and physical function (mean difference, 5.2 units; 95% CI, 1.9-8.5 units; P = .002) compared with the control. There was evidence of differences in the proportion of participants exceeding the minimal clinically important improvement in pain (intervention group, 72.1%, vs control, 42.0%; risk difference, 0.30 [95% CI, 0.16-0.44]; P <. 001) and function (intervention group, 68%, vs control, 40.8%; risk difference, 0.27 [95% CI, 0.13-0.41]; P < .001) favoring the intervention. Between-group differences for all secondary outcomes favored the intervention except for physical activity, self-efficacy for function, and self-efficacy for exercise, for which there was no evidence of differences. Conclusions and Relevance This randomized clinical trial found that a self-directed web-based strengthening exercise regimen and physical activity guidance supported by automated behavior-change text messages to encourage exercise adherence improved knee pain and function at 24 weeks. This unsupervised, free-to-access digital intervention is an effective option to improve patient access to recommended OA exercise and/or to support clinicians in providing exercise management for people with knee OA at scale across the population. Trial Registration Australian New Zealand Clinical Trials Registry Identifier: ACTRN12618001167257.",2021,"The intervention group showed greater improvements in overall knee pain (mean difference, 1.6 units; 95% CI, 0.9-2.2 units; P < .001) and physical function (mean difference, 5.2 units; 95% CI, 1.9-8.5 units; P = .002) compared with the control.","['mean [SD] age, 60 [8.4] years', 'People With Knee Osteoarthritis', '206 participants, 180 (87', 'people with knee OA', '206 people who met clinical criteria for knee OA in communities across Australia from July 2018 to August 2019, with follow-up taking place at 24 weeks']","['OA exercise', 'Self-directed Web-Based Strengthening Exercise and Physical Activity Program Supported by Automated Text Messages', 'self-directed web-based strengthening exercise and physical activity program supported by automated behavior-change text messages']","['overall knee pain (numeric rating scale, 0-10) and difficulty with physical function (Western Ontario and McMaster Universities Osteoarthritis Index, 0-68', 'pain', 'knee pain measure, sport and recreation function, quality of life, physical activity, self-efficacy, overall improvement, and treatment satisfaction', 'physical activity, self-efficacy for function, and self-efficacy for exercise', 'physical function', 'overall knee pain']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0034872', 'cui_str': 'Recreation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",206.0,0.0553334,"The intervention group showed greater improvements in overall knee pain (mean difference, 1.6 units; 95% CI, 0.9-2.2 units; P < .001) and physical function (mean difference, 5.2 units; 95% CI, 1.9-8.5 units; P = .002) compared with the control.","[{'ForeName': 'Rachel K', 'Initials': 'RK', 'LastName': 'Nelligan', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Rana S', 'Initials': 'RS', 'LastName': 'Hinman', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Kasza', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Samuel J C', 'Initials': 'SJC', 'LastName': 'Crofts', 'Affiliation': 'Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Kim L', 'Initials': 'KL', 'LastName': 'Bennell', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, The University of Melbourne, Parkville, Victoria, Australia.'}]",JAMA internal medicine,['10.1001/jamainternmed.2021.0991'] 3304,33843831,The Small 14-French (Fr) Percutaneous Catheter vs. Large (28-32Fr) Open Chest Tube for Traumatic Hemothorax (P-CAT): A Multi-center Randomized Clinical Trial.,"INTRODUCTION The traditional treatment of traumatic hemothorax (HTX) has been an insertion of a large-bore 36-40 French (FR) chest tube (CT). Our previous single-center randomized controlled trial (RCT) had shown that 14Fr percutaneous catheters (PCs) (pigtail) were equally as effective as CTs. We performed a multi-center RCT, hypothesizing that PCs are as equally effective as CTs in the management of patients with traumatic HTX. (NCT03546764). METHODS We performed a multi-institution prospective RCT comparing 14Fr PCs to 28-32Fr CTs in the management of patients with traumatic HTX from July, 2015 to September, 2020. We excluded patients who were in extremis and required emergent tube placement, and those who refused to participate. The primary outcome was failure rate, defined as a retained HTX requiring a second intervention. Secondary outcomes included daily drainage output, tube days, intensive care unit and hospital length of stay, and insertion perception experience (IPE) score on a scale of 1 to 5 (1=tolerable experience, 5=worst experience). Unpaired Student's t-test, chi-square and Wilcoxon rank-sum test was utilized with significance set at P < 0.05. RESULTS After exclusion, 119 patients participated in the trial, 56 randomized to PCs and 63 to CTs. Baseline characteristics between the two groups were similar. The primary outcome, failure rate, was similar between the 2 groups (11% PCs vs. 13% CTs, P = 0.74). All other secondary outcomes were also similar, except PC patients reported lower IPE scores (median, 1, ""I can tolerate it""; IR, 1-2) than CT patients (median, 3, ""It was a bad experience""; IR, 2-5, P<0.001). CONCLUSION Small caliber 14Fr PCs are equally as effective as 28-32Fr CTs in their ability to drain traumatic HTX with no difference in complications. Patients reported better IPE scores with PCs over CTs, suggesting PCs are better tolerated. LEVEL OF EVIDENCE Level I.",2021,"All other secondary outcomes were also similar, except PC patients reported lower IPE scores (median, 1, ""I can tolerate it""; IR, 1-2) than CT patients (median, 3, ""It was a bad experience""; IR, 2-5, P<0.001). ","['patients with traumatic HTX from July, 2015 to September, 2020', '119 patients participated in the trial, 56 randomized to PCs and 63 to CTs', 'patients who were in extremis and required emergent tube placement, and those who refused to participate', 'patients with traumatic HTX']","['traumatic hemothorax (HTX', '14Fr percutaneous catheters (PCs) (pigtail', 'Fr) Percutaneous Catheter vs. Large (28-32Fr) Open Chest Tube for Traumatic Hemothorax (P-CAT']","['daily drainage output, tube days, intensive care unit and hospital length of stay, and insertion perception experience (IPE) score on a scale of 1 to 5 (1=tolerable experience, 5=worst experience', 'tolerated', 'IPE scores', 'failure rate', 'failure rate, defined as a retained HTX requiring a second intervention']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0340006', 'cui_str': 'Traumatic hemothorax'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1136454', 'cui_str': 'Refusal to Participate'}]","[{'cui': 'C0340006', 'cui_str': 'Traumatic hemothorax'}, {'cui': 'C0019123', 'cui_str': 'Hemothorax'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C2585679', 'cui_str': '32 French gauge'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008034', 'cui_str': 'Chest drain'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0019123', 'cui_str': 'Hemothorax'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",119.0,0.105864,"All other secondary outcomes were also similar, except PC patients reported lower IPE scores (median, 1, ""I can tolerate it""; IR, 1-2) than CT patients (median, 3, ""It was a bad experience""; IR, 2-5, P<0.001). ","[{'ForeName': 'Narong', 'Initials': 'N', 'LastName': 'Kulvatunyou', 'Affiliation': 'Division of Acute Care Surgery, Department of Surgery, University of Arizona, Tucson, Arizona Division of Acute Care Surgery, Department of Surgery, University of Nebraska, Omaha, Nebraska Division of Acute Care Surgery, Department of Surgery, Medical College of Wisconsin, Milwaukee, Wisconsin Division of Acute Care Surgery, Department of Surgery, Loma Linda University, Loma Linda, California Department of Surgery, New York Medical College, Valhalla, New York.'}, {'ForeName': 'Zachary M', 'Initials': 'ZM', 'LastName': 'Bauman', 'Affiliation': ''}, {'ForeName': 'Savo Bou Zein', 'Initials': 'SBZ', 'LastName': 'Edine', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'de Moya', 'Affiliation': ''}, {'ForeName': 'Casandra', 'Initials': 'C', 'LastName': 'Krause', 'Affiliation': ''}, {'ForeName': 'Kaushik', 'Initials': 'K', 'LastName': 'Mukherjee', 'Affiliation': ''}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Gries', 'Affiliation': ''}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Bellal', 'Initials': 'B', 'LastName': 'Joseph', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rhee', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000003180'] 3305,33843820,"Effects of Ayahuasca on the Recognition of Facial Expressions of Emotions in Naive Healthy Volunteers: A Pilot, Proof-of-Concept, Randomized Controlled Trial.","BACKGROUND The recognition of emotions in facial expressions (REFE) is a core aspect of social cognition. Previous studies with the serotonergic hallucinogens lysergic acid diethylamide and psilocybin showed that these drugs reduced the recognition of negative (fear) faces in healthy volunteers. This trial assessed the acute and prolonged effects of a single dose of ayahuasca on the REFE. METHODS Twenty-two healthy volunteers participated in a pilot, proof-of-concept, randomized trial. Study variables included a REFE task performed before and 4 hours after drug intake, subjective effects (self-reports/observer impressions), tolerability measures (cardiovascular measures, self-reports), and brain-derived neurotrophic factor plasma levels. The REFE task was applied again 1, 7, 14, and 21 days and 3 months after drug intake. Stability of ayahuasca alkaloids during the study was also assessed (room temperature, 18 months). FINDINGS Compared with placebo, ayahuasca did not modify the REFE. No significant effects were observed on cardiovascular measures and brain-derived neurotrophic factor levels. Volunteers reported visual effects, tranquility/relaxation, and well-being, with few reports of transient anxiety/confusion. Ayahuasca was well tolerated, producing mainly nausea, gastrointestinal discomfort, and vomiting. A significant time-dependent deterioration of alkaloids was observed, especially for dimethyltryptamine. CONCLUSIONS Absence of significant effects on the REFE task could be due to lack of effects of ayahuasca (at the doses used), alkaloid degradation, learning effects, and the high educational level of the sample. Further trials with different samples are needed to better understand the effects of ayahuasca and other serotonergic hallucinogens on the REFE. Future trials should improve methods to guarantee the stability of ayahuasca alkaloids.",2021,No significant effects were observed on cardiovascular measures and brain-derived neurotrophic factor levels.,"['healthy volunteers', 'Naive Healthy Volunteers', 'Twenty-two healthy volunteers participated in a pilot, proof-of-concept, randomized trial']","['ayahuasca', 'ayahuasca alkaloids', 'Ayahuasca', 'placebo, ayahuasca']","['Facial Expressions of Emotions', 'subjective effects (self-reports/observer impressions), tolerability measures (cardiovascular measures, self-reports), and brain-derived neurotrophic factor plasma levels', 'recognition of negative (fear) faces', 'visual effects, tranquility/relaxation', 'time-dependent deterioration of alkaloids', 'cardiovascular measures and brain-derived neurotrophic factor levels', 'tolerated, producing mainly nausea, gastrointestinal discomfort, and vomiting']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0556981', 'cui_str': '% proof'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0330913', 'cui_str': 'Banisteriopsis'}, {'cui': 'C0002062', 'cui_str': 'Alkaloid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0199659', 'cui_str': 'Cardiovascular measure'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0002062', 'cui_str': 'Alkaloid'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C1096250', 'cui_str': 'Gastrointestinal discomfort'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",22.0,0.0369101,No significant effects were observed on cardiovascular measures and brain-derived neurotrophic factor levels.,"[{'ForeName': 'Juliana Mendes', 'Initials': 'JM', 'LastName': 'Rocha', 'Affiliation': 'From the Department of Neurosciences and Behavior, Ribeirão Preto Medical School, University of São Paulo National Institute of Science and Technology-Translational Medicine, Ribeirão Preto, Brazil ICEERS Foundation, International Center for Ethnobotanical Education, Research and Services, Barcelona Medical Anthopology Research Center, Universitat Rovira i Virgili, Tarragona, Spain School of Pharmaceutical Sciences Department of Pharmacology, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Giordano Novak', 'Initials': 'GN', 'LastName': 'Rossi', 'Affiliation': ''}, {'ForeName': 'Flávia', 'Initials': 'F', 'LastName': 'de Lima Osório', 'Affiliation': ''}, {'ForeName': 'José Carlos', 'Initials': 'JC', 'LastName': 'Bouso', 'Affiliation': ''}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'de Oliveira Silveira', 'Affiliation': ''}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Yonamine', 'Affiliation': ''}, {'ForeName': 'Alline Cristina', 'Initials': 'AC', 'LastName': 'Campos', 'Affiliation': ''}, {'ForeName': 'Giuliana', 'Initials': 'G', 'LastName': 'Bertozi', 'Affiliation': ''}, {'ForeName': 'Hallak Jaime E', 'Initials': 'HJE', 'LastName': 'Cecílio', 'Affiliation': ''}, {'ForeName': 'Rafael G', 'Initials': 'RG', 'LastName': 'Dos Santos', 'Affiliation': ''}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001396'] 3306,33843798,Effect of Short-Term Homebased Pre- and Postoperative Exercise on Recovery after Colorectal Cancer Surgery (PHYSSURG-C): A Randomized Clinical Trial.,"OBJECTIVE To determine the effect of a short-term, unsupervised exercise intervention before and after colorectal cancer surgery on self-assessed physical recovery. SUMMARY BACKGROUND DATA Preoperative exercise interventions could help improve recovery after colorectal cancer surgery and is currently recommended. METHODS A randomized, parallel, open-label trial in six university or regional hospitals in Sweden. Inclusion criteria were age ≥20 years and planned elective colorectal cancer surgery. Participants were randomised to either a physical activity intervention with aerobic activity and inspiratory muscle training two weeks pre- and four weeks postoperatively or usual care. The primary outcome measure was self-assessed physical recovery four weeks postoperatively. Analyses were performed according to intention to treat. Outcome assessors were masked regarding the intervention while both participants and physiotherapists were informed due to the nature of the intervention. RESULTS Between Jan 22, 2015, and May 28, 2020, 761 participants were recruited and assigned to either intervention (I) (n = 379) or control (C) (n = 382). After exclusions 668 participants (I = 317, C = 351) were included in the primary analysis. There was no effect from the intervention on the primary outcome measure (adjusted odds ratio (OR) 0.84, 95% confidence interval (CI) 0.62 - 1.15) with 13% and 15% of participants feeling fully physically recovered in I and C respectively. There were no reported adverse events. CONCLUSIONS There was no effect from a physical activity intervention before and after colorectal cancer surgery on short-term self-assessed physical recovery. The results from this study call for reconsiderations regarding current recommendations for preoperative physical activity interventions.",2021,There was no effect from a physical activity intervention before and after colorectal cancer surgery on short-term self-assessed physical recovery.,"['Recovery after Colorectal Cancer Surgery (PHYSSURG-C', 'Between Jan 22, 2015, and May 28, 2020, 761 participants were recruited and assigned to either intervention (I) (n = 379) or control (C) (n = 382', 'After exclusions 668 participants (I = 317, C = 351) were included in the primary analysis', 'Inclusion criteria were age ≥20\u200ayears and planned elective colorectal cancer surgery', 'six university or regional hospitals in Sweden']","['short-term, unsupervised exercise intervention', 'physical activity intervention with aerobic activity and inspiratory muscle training two weeks pre- and four weeks postoperatively or usual care', 'Short-Term Homebased Pre- and Postoperative Exercise']","['adverse events', 'physical activity intervention', 'self-assessed physical recovery']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517750', 'cui_str': '382'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",761.0,0.326821,There was no effect from a physical activity intervention before and after colorectal cancer surgery on short-term self-assessed physical recovery.,"[{'ForeName': 'Aron', 'Initials': 'A', 'LastName': 'Onerup', 'Affiliation': 'Scandinavian Surgical Outcomes Research Group (SSORG), Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden Region Västra Götaland, Sahlgrenska University Hospital, Department of Pediatric Oncology, Gothenburg, Sweden Region Västra Götaland, Alingsås Hospital, Department of Surgery, Alingsås, Sweden Region Västra Götaland, Sahlgrenska University Hospital, Department of Surgery, Gothenburg, Sweden Center for Health and Performance, Dept of molecular and Clinical Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden Region Västra Götaland, Sahlgrenska University Hospital, Department of Medicine, Gothenburg, Sweden Department of Health and Rehabilitation/Physiotherapy, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden Department of Surgery, Skaraborgs hospital, Skövde, Sweden.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Andersson', 'Affiliation': ''}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Angenete', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bock', 'Affiliation': ''}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Börjesson', 'Affiliation': ''}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Ehrencrona', 'Affiliation': ''}, {'ForeName': 'Monika Fagevik', 'Initials': 'MF', 'LastName': 'Olsén', 'Affiliation': ''}, {'ForeName': 'Per-Anders', 'Initials': 'PA', 'LastName': 'Larsson', 'Affiliation': ''}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'de la Croix', 'Affiliation': ''}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Wedin', 'Affiliation': ''}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Haglind', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004901'] 3307,33843789,Estrogen As A Safe Therapeutic Adjunct in Reducing The Inflammatory Storm in Trauma Hemorrhagic Shock Patients.,"ABSTRACT Trauma is a major cause of death and disability throughout the world. It is a leading cause of death with or without sepsis in about 50% of patients. Limited therapeutic options are available besides definitive care with a mortality benefit. Pre-clinical studies have demonstrated the mortality benefit of estrogen in trauma hemorrhagic shock(THS). Based on encouraging results from pre-clinical studies, we hypothesised that early administration of estrogen in male THS patients may reduce the inflammatory storm, prevent sepsis associated problems, and subsequently reduce mortality. The authors studied the safety of early administration of estrogen as a therapeutic adjunct in the emergency department (ED) and its effects on the inflammatory storm, prevention of sepsis, and mortality during the intensive care unit (ICU) stay. 40, THS patients were recruited. THS patients were divided into experimental and placebo control groups based on the estrogen administration in the ED. Serum levels of cytokines and immune cells were measured at different time points on days 0, 3, 7, and 14 in both groups of THS patients. The experimental group received intravenous estrogen (25 mg) at a single time point in the ED beside standard of care as per advanced trauma life support (ATLS) guidelines. Patients did not develop any major or minor adverse events and showed favorable clinical outcomes in the experimental group. The levels of T regulatory cells, monocytes, and systemic cytokines significantly reduced and showed a balanced inflammatory response in THS patients who received estrogen.In conclusion, this preliminary study showed that intravenous estrogen therapy is safe and reduced the inflammatory insult due to trauma hemorrhagic shock. It may protect THS patients from sepsis-associated complications. Future clinical trials are required to study the efficacy and mechanistic pathway.",2021,"The levels of T regulatory cells, monocytes, and systemic cytokines significantly reduced and showed a balanced inflammatory response in THS patients who received estrogen.","['40, THS patients were recruited', 'THS patients', 'male THS patients', 'Trauma Hemorrhagic Shock Patients']","['intravenous estrogen (25\u200amg) at a single time point in the ED beside standard of care as per advanced trauma life support (ATLS) guidelines', 'intravenous estrogen therapy', 'estrogen', 'Estrogen']","['Serum levels of cytokines and immune cells', 'levels of T regulatory cells, monocytes, and systemic cytokines']","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0036982', 'cui_str': 'Hemorrhagic shock'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C3494237', 'cui_str': 'Advanced Trauma Life Support'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C1267822', 'cui_str': 'T lymphocyte positive for both CD4 antigen and CD25 antigen'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}]",,0.110158,"The levels of T regulatory cells, monocytes, and systemic cytokines significantly reduced and showed a balanced inflammatory response in THS patients who received estrogen.","[{'ForeName': 'Dublu Lal', 'Initials': 'DL', 'LastName': 'Gupta', 'Affiliation': 'Department of Biochemistry, All India Institute of Medical Sciences, Raipur, Chhattisgarh, India Department of Emergency Medicine, JPNATC, All India Institute of Medical Sciences, New Delhi, India Department of Intensive & Critical Care, JPNATC, All India Institute of Medical Sciences, New Delhi, India Department of Emergency Medicine, Florida State University, Sarasota Florida, USA Department of Surgery, JPNATC, All India Institute of Medical Sciences, New Delhi, India Department of Biochemistry, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Shrestha', 'Initials': 'S', 'LastName': 'Tiwari', 'Affiliation': ''}, {'ForeName': 'Tej Prakash', 'Initials': 'TP', 'LastName': 'Sinha', 'Affiliation': ''}, {'ForeName': 'Kapil Dev', 'Initials': 'KD', 'LastName': 'Soni', 'Affiliation': ''}, {'ForeName': 'Sagar', 'Initials': 'S', 'LastName': 'Galwnkar', 'Affiliation': ''}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': ''}, {'ForeName': 'D N', 'Initials': 'DN', 'LastName': 'Rao', 'Affiliation': ''}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Bhoi', 'Affiliation': ''}]","Shock (Augusta, Ga.)",['10.1097/SHK.0000000000001779'] 3308,33843705,Effect of posture control training using a virtual reality program on sitting balance and trunk stability in children with cerebral palsy.,"OBJECTIVE We aimed to determine whether the posture control training in the sitting posture using virtual reality (VR) training program affects sitting balance and trunk stability in children with spastic cerebral palsy (CP). METHODS The experiment was conducted for 4 weeks by randomly allocating 20 children with CP. The experimental group (n = 10) performed balance training in the sitting position using a VR training program, and the control group (n = 10) performed arm reach training in the sitting position. To evaluate static and dynamic sitting balance and trunk stability, the Wii Balance Board and Balancia software, the modified functional reach test, and the Korean version of the Trunk Control Measurement Scale were used. RESULTS There were significant differences between the two groups in the changes in speed and postural swing distance before and after training (p <  0.05). The mFRT measurement showed significant differences in all directions before and after training between the two groups (p <  0.05). However, there was no significant difference between the two groups in the K-TCMS score. CONCLUSIONS Posture control training in the sitting position using a VR training program was found to be more effective in improving the sitting balance and trunk stability of children with CP.",2021,There were significant differences between the two groups in the changes in speed and postural swing distance before and after training (p <  0.05).,"['20 children with CP', 'children with spastic cerebral palsy (CP', 'children with CP', 'children with cerebral\xa0palsy']","['posture control training', 'balance training in the sitting position using a VR training program, and the control group (n\u200a=\u200a10) performed arm reach training in the sitting position', 'virtual reality (VR) training program', 'Posture control training']","['speed and postural swing distance', 'K-TCMS score', 'sitting balance and trunk stability']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy'}]","[{'cui': 'C0561949', 'cui_str': 'Does control posture'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0516712', 'cui_str': 'Balancing when sitting'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",20.0,0.00400349,There were significant differences between the two groups in the changes in speed and postural swing distance before and after training (p <  0.05).,"[{'ForeName': 'Se-Hee', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, College of Health Science, Cheongju University, Cheongju, Republic of Korea.'}, {'ForeName': 'Sung-Min', 'Initials': 'SM', 'LastName': 'Son', 'Affiliation': 'Department of Physical Therapy, College of Health Science, Cheongju University, Cheongju, Republic of Korea.'}, {'ForeName': 'Ji-Young', 'Initials': 'JY', 'LastName': 'Choi', 'Affiliation': 'Department of Physical Therapy, College of Health Science, Cheongju University, Cheongju, Republic of Korea.'}]",NeuroRehabilitation,['10.3233/NRE-201642'] 3309,33843675,Effects of Morning Blue-Green 500 nm Light Therapy on Cognition and Biomarkers in Middle-Aged and Older Adults with Subjective Cognitive Decline and Mild Cognitive Impairment: Study Protocol for a Randomized Controlled Trial.,"BACKGROUND Given that there is no specific drug to treat Alzheimer's disease, non-pharmacologic interventions in people with subjective cognitive decline (SCD) and amnestic mild cognitive impairment (aMCI) are one of the most important treatment strategies. OBJECTIVE To clarify the efficacy of blue-green (500 nm) light therapy on sleep, mood, and physiological parameters in patients with SCD and aMCI is an interesting avenue to explore. METHODS This is a monocentric, randomized, and controlled trial that will last for 4 weeks. We will recruit 150 individuals aged 45 years or older from memory clinics and divide them into 5 groups: SCD treatment (n = 30), SCD control (n = 30), aMCI treatment (n = 30), aMCI control (n = 30), and a group of healthy adult subjects (n = 30) as a normal control (NC). RESULTS The primary outcome is the change in subjective and objective cognitive performance between baseline and postintervention visits (4 weeks after baseline). Secondary outcomes include changes in performance assessing from baseline, postintervention to follow-up (3 months after the intervention), as well as sleep, mood, and physiological parameters (including blood, urine, electrophysiology, and neuroimaging biomarkers). CONCLUSION This study aims to provide evidence of the impact of light therapy on subjective and objective cognitive performance in middle-aged and older adults with SCD or aMCI. In addition, we will identify possible neurophysiological mechanisms of action underlying light therapy. Overall, this trial will contribute to the establishment of light therapy in the prevention of Alzheimer's disease.",2021,"Secondary outcomes include changes in performance assessing from baseline, postintervention to follow-up (3 months after the intervention), as well as sleep, mood, and physiological parameters (including blood, urine, electrophysiology, and neuroimaging biomarkers). ","['150 individuals aged 45 years or older from memory clinics and divide them into 5 groups', 'patients with SCD and aMCI', 'Middle-Aged and Older Adults with Subjective Cognitive Decline and Mild Cognitive Impairment', 'middle-aged and older adults with SCD or aMCI', 'people with subjective cognitive decline (SCD) and amnestic mild cognitive impairment (aMCI']","['normal control (NC', 'light therapy', 'SCD treatment', 'aMCI treatment', 'blue-green (500\u200anm) light therapy', 'Morning Blue-Green 500\u200anm Light Therapy', 'aMCI control', 'SCD control']","['changes in performance assessing from baseline, postintervention to follow-up (3 months after the intervention), as well as sleep, mood, and physiological parameters (including blood, urine, electrophysiology, and neuroimaging biomarkers', 'subjective and objective cognitive performance', 'Cognition and Biomarkers', 'change in subjective and objective cognitive performance between baseline and postintervention visits']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C1319009', 'cui_str': 'Blue green color'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0332170', 'cui_str': 'Morning'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0013865', 'cui_str': 'Electrophysiology'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",150.0,0.227667,"Secondary outcomes include changes in performance assessing from baseline, postintervention to follow-up (3 months after the intervention), as well as sleep, mood, and physiological parameters (including blood, urine, electrophysiology, and neuroimaging biomarkers). ","[{'ForeName': 'Ziqi', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Lab for Neuroinformation, School of Life Science and Technology, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Yige', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Lab for Neuroinformation, School of Life Science and Technology, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Zihao', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Lab for Neuroinformation, School of Life Science and Technology, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Dayong', 'Initials': 'D', 'LastName': 'Zhong', 'Affiliation': 'Sichuan Provincial Revolutionary Disabled Soldiers Hospital, Chengdu, China.'}, {'ForeName': 'Xunqin', 'Initials': 'X', 'LastName': 'Long', 'Affiliation': 'The Memory Clinic of department of Neurology, Chengdu Western Hospital, Chengdu, China.'}, {'ForeName': 'Qingyan', 'Initials': 'Q', 'LastName': 'Cai', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Lab for Neuroinformation, School of Life Science and Technology, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Jian', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Lab for Neuroinformation, School of Life Science and Technology, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Songge', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'The Memory Clinic of department of Neurology, Chengdu Western Hospital, Chengdu, China.'}, {'ForeName': 'Wenbin', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Dezhong', 'Initials': 'D', 'LastName': 'Yao', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Lab for Neuroinformation, School of Life Science and Technology, University of Electronic Science and Technology of China, Chengdu, China.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-201560'] 3310,33843667,Nattokinase atherothrombotic prevention study: A randomized controlled trial.,"BACKGROUND Described to be antithrombotic and antihypertensive, nattokinase is consumed for putative cardiovascular benefit. However, no large-scale, long-term cardiovascular study has been conducted with nattokinase supplementation. OBJECTIVE To determine the effect of nattokinase on subclinical atherosclerosis progression and atherothrombotic biomarkers. METHODS In this double-blinded trial, 265 individuals of median age 65.3 years, without clinical evidence of cardiovascular disease (CVD) were randomized to oral nattokinase 2,000 fibrinolytic units or matching placebo. Primary outcome was rate of change in subclinical atherosclerosis measured by serial carotid ultrasound every 6 months as carotid artery intima-media thickness (CIMT) and carotid arterial stiffness (CAS). Additional outcomes determined at least every 6 months were clinical parameters including blood pressure and laboratory measures including metabolic factors, blood rheology parameters, blood coagulation and fibrinolysis factors, inflammatory markers and monocyte/macrophage cellular activation markers. RESULTS After median 3 years of randomized treatment, annualized rate of change in CIMT and CAS did not significantly differ between nattokinase supplementation and placebo. Additionally, there was no significant effect of nattokinase supplementation on blood pressure or any laboratory determination. CONCLUSIONS Results of this trial show that nattokinase supplementation has a null effect on subclinical atherosclerosis progression in healthy individuals at low risk for CVD.",2021,"After median 3 years of randomized treatment, annualized rate of change in CIMT and CAS did not significantly differ between nattokinase supplementation and placebo.","['Nattokinase atherothrombotic prevention study', 'healthy individuals at low risk for CVD', '265 individuals of median age 65.3 years, without clinical evidence of cardiovascular disease (CVD']","['nattokinase', 'placebo', 'oral nattokinase 2,000 fibrinolytic units or matching placebo', 'nattokinase supplementation']","['blood pressure', 'annualized rate of change in CIMT and CAS', 'blood pressure and laboratory measures including metabolic factors, blood rheology parameters, blood coagulation and fibrinolysis factors, inflammatory markers and monocyte/macrophage cellular activation markers', 'subclinical atherosclerosis progression', 'rate of change in subclinical atherosclerosis measured by serial carotid ultrasound every 6 months as carotid artery intima-media thickness (CIMT) and carotid arterial stiffness (CAS', 'subclinical atherosclerosis progression and atherothrombotic biomarkers']","[{'cui': 'C0131956', 'cui_str': 'nattokinase'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}]","[{'cui': 'C0131956', 'cui_str': 'nattokinase'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0040044', 'cui_str': 'Thrombolytic therapy'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0035423', 'cui_str': 'Rheology'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0016017', 'cui_str': 'Fibrinolysis'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0585339', 'cui_str': 'Every six months'}]",,0.64898,"After median 3 years of randomized treatment, annualized rate of change in CIMT and CAS did not significantly differ between nattokinase supplementation and placebo.","[{'ForeName': 'Howard N', 'Initials': 'HN', 'LastName': 'Hodis', 'Affiliation': 'Atherosclerosis Research Unit, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Mack', 'Affiliation': 'Atherosclerosis Research Unit, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Herbert J', 'Initials': 'HJ', 'LastName': 'Meiselman', 'Affiliation': 'Department of Physiology and Biophysics, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Kalra', 'Affiliation': 'Department of Biochemistry, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Liebman', 'Affiliation': 'Department of Medicine, Keck School of Medicine, University of Southern California, CA, Los Angeles, USA.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Hwang-Levine', 'Affiliation': 'Atherosclerosis Research Unit, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Dustin', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Kono', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Mert', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Rosalinda B', 'Initials': 'RB', 'LastName': 'Wenby', 'Affiliation': 'Department of Physiology and Biophysics, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Huesca', 'Affiliation': 'Department of Biochemistry, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Yanjie', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Atherosclerosis Research Unit, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Mingzhu', 'Initials': 'M', 'LastName': 'Yan', 'Affiliation': 'Atherosclerosis Research Unit, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Jan A', 'Initials': 'JA', 'LastName': 'St John', 'Affiliation': 'Atherosclerosis Research Unit, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Lora', 'Initials': 'L', 'LastName': 'Whitfield', 'Affiliation': 'Atherosclerosis Research Unit, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}]",Clinical hemorheology and microcirculation,['10.3233/CH-211147'] 3311,33843602,Effects of an animated blood clot on the decision-making of users inexperienced in viscoelastic testing - Visual Clot technology: a multicenter trial.,"BACKGROUND Viscoelastic-test-guided coagulation management has become increasingly important in assessing hemostasis. We developed Visual Clot, an animated, 3-dimensional blood clot that illustrates raw rotational thromboelastometry (ROTEM) parameters in a user-centered and situation awareness-oriented method. OBJECTIVE This study aimed to evaluate the applicability of Visual Clot by examining its effects on users that are novices in viscoelastic-guided resuscitation. METHODS We conducted an investigator-initiated, international, multicenter study between September 16 and October 6, 2020, in five tertiary care hospitals in central Europe. We randomly recruited medical students and inexperienced resident physicians without significant prior exposure to viscoelastic testing. The 7 participants per center managed nine different ROTEM outputs twice, once as standard ROTEM tracings and once as the corresponding Visual Clot. We randomly presented the 18 viscoelastic cases and asked the participants for their therapeutic decisions. We assessed the performance, diagnostic confidence, and perceived workload in managing the tasks using mixed statistical models, adjusted for possible confounding factors. RESULTS Analyzing a total of 630 results, we found that the participants solved more cases correctly (odds ratio [OR]: 33.66; 95% confidence interval [CI]: 21.13-53.64; P<0.001), perceived more diagnostic confidence (OR: 206.2; 95% CI: 93.5-454.75; P<0.001) and less workload (coefficient -41.63; 95% CI: -43.91 to -39.36; P<0.001) using Visual Clot compared to using standard ROTEM tracings. CONCLUSIONS This study emphasizes the practical benefit of presenting viscoelastic test results in a user-centered way. Visual Clot may allow inexperienced users to be involved in the decision-making process to treat bleeding-associated coagulopathy. The increased diagnostic confidence, diagnostic certainty, reduced workload, and positive user feedback associated with this visualization may promote the further adoption of viscoelastic methods in diverse healthcare settings.",2021,"Analyzing a total of 630 results, we found that the participants solved more cases correctly (odds ratio [OR]: 33.66; 95% confidence interval [CI]: 21.13-53.64; P<0.001), perceived more diagnostic confidence (OR: 206.2; 95% CI: 93.5-454.75; P<0.001) and less workload (coefficient -41.63","['September 16 and October 6, 2020, in five tertiary care hospitals in central Europe']","['viscoelastic testing - Visual Clot technology', 'animated blood clot', 'inexperienced resident physicians without significant prior exposure to viscoelastic testing']","['diagnostic confidence', 'performance, diagnostic confidence, and perceived workload', 'diagnostic confidence, diagnostic certainty, reduced workload, and positive user feedback']","[{'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015176', 'cui_str': 'Europe'}]","[{'cui': 'C0042793', 'cui_str': 'Visual testing'}, {'cui': 'C0009074', 'cui_str': 'Clotrimazole'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",,0.13143,"Analyzing a total of 630 results, we found that the participants solved more cases correctly (odds ratio [OR]: 33.66; 95% confidence interval [CI]: 21.13-53.64; P<0.001), perceived more diagnostic confidence (OR: 206.2; 95% CI: 93.5-454.75; P<0.001) and less workload (coefficient -41.63","[{'ForeName': 'Sadiq', 'Initials': 'S', 'LastName': 'Said', 'Affiliation': 'Institute of Anesthesiology, University of Zurich and University Hospital Zurich, Rämistrasse 100, Zurich, CH.'}, {'ForeName': 'Tadzio Raoul', 'Initials': 'TR', 'LastName': 'Roche', 'Affiliation': 'Institute of Anesthesiology, University of Zurich and University Hospital Zurich, Rämistrasse 100, Zurich, CH.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Braun', 'Affiliation': 'Departments of Epidemiology and Biostatistics, Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, CH.'}, {'ForeName': 'Micheal Thomas', 'Initials': 'MT', 'LastName': 'Ganter', 'Affiliation': 'Institute of Anesthesiology and Pain Therapy, Cantonal Hospital Winterthur, Winterthur, CH.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Meybohm', 'Affiliation': 'Department of Anesthesiology, Intensive Care, Emergency and Pain Medicine, University Hospital Wuerzburg, University of Wuerzburg, Wuerzburg, DE.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Herrmann', 'Affiliation': 'Department of Anesthesiology, Intensive Care, Emergency and Pain Medicine, University Hospital Wuerzburg, University of Wuerzburg, Wuerzburg, DE.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Zacharowski', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt, DE.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Rivas', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, Hospital Clinic of Barcelona, University of Barcelona, Barcelona, ES.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Lopez-Baamonde', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, Hospital Clinic of Barcelona, University of Barcelona, Barcelona, ES.'}, {'ForeName': 'Florian Jürgen', 'Initials': 'FJ', 'LastName': 'Raimann', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt, DE.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Piekarski', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt, DE.'}, {'ForeName': 'Donat Rudolf', 'Initials': 'DR', 'LastName': 'Spahn', 'Affiliation': 'Institute of Anesthesiology, University of Zurich and University Hospital Zurich, Zurich, CH.'}, {'ForeName': 'Christoph Beat', 'Initials': 'CB', 'LastName': 'Nöthiger', 'Affiliation': 'Institute of Anesthesiology, University of Zurich and University Hospital Zurich, Rämistrasse 100, Zurich, CH.'}, {'ForeName': 'David Werner', 'Initials': 'DW', 'LastName': 'Tscholl', 'Affiliation': 'Institute of Anesthesiology, University of Zurich and University Hospital Zurich, Rämistrasse 100, Zurich, CH.'}]",Journal of medical Internet research,['10.2196/27124'] 3312,33843566,The impact of health warnings for sugar-sweetened beverages on consumer perceptions of advertising.,"OBJECTIVE In February 2020, San Francisco proposed mandatory health warnings for sugar-sweetened beverage (SSB) advertisements. Industry legal challenges stated that the warning would detract from advertisers' ability to convey their intended message, and mislead consumers into believing that SSBs cause weight gain regardless of consumption amount, lifestyle, or intake of other energy-dense foods. DESIGN Online between-group experiments tested the impact of SSB warnings on advertising outcomes and consumer perceptions. Respondents were randomized to view six SSB print advertisements with or without a health warning ('Warning' and 'No Warning' condition, respectively). Linear and binary logistic regression models tested differences between groups, including ad recall, brand perceptions, and beliefs about SSB health effects. SETTING Panelists from the US Nielsen Global Panel. PARTICIPANTS 16-65-year-old respondents (n=1,064). RESULTS Overall, 69.2% of participants in the 'Warning' condition recalled seeing warnings on SSB ads. Compared to the 'No Warning' condition, participants in the 'Warning' condition who reported noticing the warnings were equally likely to recall the brands featured in the SSB ads, and to recall specific attributes of the final ad they viewed. Similarly, no differences were observed between groups in perceptions of SSBs, such as perceived taste, or in the prevalence of false beliefs regarding the health effects of SSBs and intake of other sugary foods on weight gain. CONCLUSIONS Overall, there was no evidence that SSB health warnings detracted from attention to promotional elements in advertisements, nor that the warnings misled consumers into false beliefs about SSBs as the exclusive cause of weight gain.",2021,"Compared to the 'No Warning' condition, participants in the 'Warning' condition who reported noticing the warnings were equally likely to recall the brands featured in the SSB ads, and to recall specific attributes of the final ad they viewed.","['In February 2020, San Francisco proposed mandatory health warnings for sugar-sweetened beverage (SSB) advertisements', '16-65-year-old respondents (n=1,064', 'Panelists from the US Nielsen Global Panel']","[""SSB print advertisements with or without a health warning ('Warning' and 'No Warning' condition, respectively""]","['ad recall, brand perceptions, and beliefs about SSB health effects', 'weight gain']","[{'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0441833', 'cui_str': 'Groups'}]","[{'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",,0.105351,"Compared to the 'No Warning' condition, participants in the 'Warning' condition who reported noticing the warnings were equally likely to recall the brands featured in the SSB ads, and to recall specific attributes of the final ad they viewed.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hammond', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, 200 University Ave W, Waterloo, ONN2L 3G1Canada.'}, {'ForeName': 'Rachel B', 'Initials': 'RB', 'LastName': 'Acton', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, 200 University Ave W, Waterloo, ONN2L 3G1Canada.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Goodman', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, 200 University Ave W, Waterloo, ONN2L 3G1Canada.'}]",Public health nutrition,['10.1017/S1368980021001257'] 3313,33843562,Prospective BMI changes in preschool children are not effected by changes in EBRBs but by parental characteristics and body weight perceptions: The ToyBox-study.,"OBJECTIVE To examine the effect of the intervention implemented in the ToyBox study on changes observed in age and sex specific BMI percentile and investigate the role of perinatal factors, parental perceptions and characteristics on this change. DESIGN A multicomponent, kindergarten-based, family-involved intervention with a cluster-randomized design. A standardized protocol was used to measure children's body weight and height. Information was also collected from parents/caregivers via the use of validated questionnaires. Linear mixed effect models with random intercept for country, socio-economic status and school were used. SETTING Selected preschools within the provinces of Oost-Flanders and West-Flanders (Belgium), Varna (Bulgaria), Bavaria (Germany), Attica (Greece), Mazowieckie (Poland) and Zaragoza (Spain). PARTICIPANTS A sample of 6,268 pre-schoolers aged 3.5-5.5 (51.9% boys). RESULTS There was no intervention effect on the change in children's BMI percentile. However, parents' underestimation of their children's actual weight status, parental overweight and mothers' pre-pregnancy overweight/obesity were found to be significantly and independently associated with increases in children's BMI percentile in multivariate modelling. CONCLUSION Before or as part of the implementation of any childhood obesity intervention initiative, it is important to assist parents/caregivers to correctly perceive their own and their children's weight status. Recognition of excessive weight by parents/caregivers can increase their readiness to change and as such facilitate higher adherence to favourable behavioural changes within the family.",2021,Recognition of excessive weight by parents/caregivers can increase their readiness to change and as such facilitate higher adherence to favourable behavioural changes within the family.,"['preschool children', 'A sample of 6,268 pre-schoolers aged 3.5-5.5 (51.9% boys', 'Selected preschools within the provinces of Oost-Flanders and West-Flanders (Belgium), Varna (Bulgaria), Bavaria (Germany), Attica (Greece), Mazowieckie (Poland) and Zaragoza (Spain']",[],"[""children's BMI percentile""]","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C1875156', 'cui_str': 'Flanders'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}]",,0.0146863,Recognition of excessive weight by parents/caregivers can increase their readiness to change and as such facilitate higher adherence to favourable behavioural changes within the family.,"[{'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Manios', 'Affiliation': 'Department of Nutrition and Dietetics; School of Health Science and Education; Harokopio University; 70 El Venizelou Avenue, Kallithea17671Athens, Greece.'}, {'ForeName': 'Katrina A', 'Initials': 'KA', 'LastName': 'Lambert', 'Affiliation': 'Department of Public Health, School of Psychology and Public Health, La Trobe University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Karaglani', 'Affiliation': 'Department of Nutrition and Dietetics; School of Health Science and Education; Harokopio University; 70 El Venizelou Avenue, Kallithea17671Athens, Greece.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Mavrogianni', 'Affiliation': 'Department of Nutrition and Dietetics; School of Health Science and Education; Harokopio University; 70 El Venizelou Avenue, Kallithea17671Athens, Greece.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Moreno', 'Affiliation': 'GENUD (Growth, Exercise, NUtrition and Development) Research Group, University of Zaragoza, C/Corona de Aragon, Zaragoza, Spain.'}, {'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'Iotova', 'Affiliation': 'Department of Pediatrics, Medical University Varna, Varna, Bulgaria.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Świąder-Leśniak', 'Affiliation': ""The Children's Memorial Health Institute, Warsaw, Poland.""}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Koletzko', 'Affiliation': ""Ludwig-Maximilians-Universität Munich, Dr von Hauner Children's Hospital, University of Munich Medical Centre, Munich, Germany.""}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'Cardon', 'Affiliation': 'Department of Movement and Sports Sciences, Ghent University, Watersportlaan 2, Ghent, Belgium.'}, {'ForeName': 'Odysseas', 'Initials': 'O', 'LastName': 'Androutsos', 'Affiliation': 'Department of Nutrition and Dietetics, School of Physical Education, Sport Science and Dietetics, University of Thessaly, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Moschonis', 'Affiliation': 'Department of Dietetics, Nutrition and Sport, School of Allied Health, Human Services and Sport, La Trobe University, Victoria, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Public health nutrition,['10.1017/S1368980021001518'] 3314,33843514,Thirty-year outcome of anxiety and depressive disorders and personality status: comprehensive evaluation of mixed symptoms and the general neurotic syndrome in the follow-up of a randomised controlled trial.,"BACKGROUND Cohort studies of the long-term outcome of anxiety, depression and personality status rarely join together. METHODS Two hundred and ten patients recruited with anxiety and depression to a randomised controlled trial between 1983 and 1987 (Nottingham Study of Neurotic Disorder) were followed up over 30 years. At trial entry personality status was assessed, together with the general neurotic syndrome, a combined diagnosis of mixed anxiety-depression (cothymia) linked to neurotic personality traits. Personality assessment used a procedure allowing conversion of data to the ICD-11 severity classification of personality disorder. After the original trial, seven further assessments were made. Observer and self-ratings of psychopathology and global outcome were also made. The primary outcome at 30 years was the proportion of those with no Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnosis.Data were analysed using multilevel repeated measures models that adjusted for age and gender. Missing data were assumed to be missing at random, and the models allowed all subjects to be included in the analysis with missing data automatically handled in the model estimation. RESULTS At 30 years, 69% of those with a baseline diagnosis of panic disorder had no DSM diagnosis compared to 37-47% of those with generalised anxiety disorder, dysthymia or mixed symptoms (cothymia) (p = 0.027). Apart from those with no personality dysfunction at entry all patients had worse outcomes after 30 years with regard to total psychopathology, anxiety and depression, social function and global outcome. CONCLUSIONS The long-term outcome of disorders formerly called 'neurotic' is poor with the exception of panic disorder. Personality dysfunction accentuates poor recovery.",2021,"Apart from those with no personality dysfunction at entry all patients had worse outcomes after 30 years with regard to total psychopathology, anxiety and depression, social function and global outcome. ",['Two hundred and ten patients recruited with anxiety and depression to a randomised controlled trial between 1983 and 1987'],[],"['proportion of those with no Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnosis', 'generalised anxiety disorder, dysthymia or mixed symptoms (cothymia', 'DSM diagnosis', 'total psychopathology, anxiety and depression, social function and global outcome', 'Observer and self-ratings of psychopathology and global outcome']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0456591', 'cui_str': '1987'}]",[],"[{'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0013415', 'cui_str': 'Dysthymia'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",210.0,0.113942,"Apart from those with no personality dysfunction at entry all patients had worse outcomes after 30 years with regard to total psychopathology, anxiety and depression, social function and global outcome. ","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Tyrer', 'Affiliation': 'Division of Psychiatry, Imperial College, W12 0NN, London, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Tyrer', 'Affiliation': 'Division of Psychiatry, Imperial College, W12 0NN, London, UK.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Johnson', 'Affiliation': 'University College, London, UK.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'West China School of Public Health, Sichuan University, Chengdu, China.'}]",Psychological medicine,['10.1017/S0033291721000878'] 3315,33843502,"Effect of adjunctive sodium hyaluronate versus surfactant nasal irrigation on mucociliary clearance in allergic rhinitis: a single-blind, randomised, controlled study.","OBJECTIVE To investigate the effects of nasal irrigation with sodium hyaluronate and surfactant solutions on mucociliary clearance time in patients with mild persistent allergic rhinitis. METHODS A total of 120 patients diagnosed with mild persistent allergic rhinitis were enrolled in this prospective study. The patients were allocated randomly to the surfactant, sodium hyaluronate or isotonic saline (as a control) nasal irrigation group. The mucociliary clearance times and improvements in mucociliary clearance times were compared. RESULTS Improvements in mean mucociliary clearance time were significantly greater in the surfactant and sodium hyaluronate groups than in the control group (p < 0.01). The mean post-treatment mucociliary clearance time of the surfactant group was significantly lower than that of the control (p < 0.001) and sodium hyaluronate groups (p = 0.03). CONCLUSION Surfactant and sodium hyaluronate nasal irrigation solutions may both be used as adjunctive treatments for allergic rhinitis. Surfactant nasal irrigation resulted in better mucociliary clearance times.",2021,"RESULTS Improvements in mean mucociliary clearance time were significantly greater in the surfactant and sodium hyaluronate groups than in the control group (p < 0.01).","['allergic rhinitis', 'patients with mild persistent allergic rhinitis', '120 patients diagnosed with mild persistent allergic rhinitis']","['Surfactant and sodium hyaluronate nasal irrigation solutions', 'sodium hyaluronate and surfactant solutions', 'surfactant, sodium hyaluronate or isotonic saline (as a control) nasal irrigation group', 'adjunctive sodium hyaluronate versus surfactant nasal irrigation', 'Surfactant nasal irrigation']","['mucociliary clearance time', 'mean mucociliary clearance time', 'mucociliary clearance times', 'mucociliary clearance', 'mean post-treatment mucociliary clearance time']","[{'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0087000', 'cui_str': 'Hyaluronate sodium'}, {'cui': 'C2350442', 'cui_str': 'Nasal irrigation'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0026687', 'cui_str': 'Mucociliary clearance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",120.0,0.010227,"RESULTS Improvements in mean mucociliary clearance time were significantly greater in the surfactant and sodium hyaluronate groups than in the control group (p < 0.01).","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ocak', 'Affiliation': 'Department of Otorhinolaryngology, Ankara University Medical School, Ankara, Turkey.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mulazimoglu', 'Affiliation': 'Department of Otorhinolaryngology, Ankara University Medical School, Ankara, Turkey.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kocaoz', 'Affiliation': 'Department of Otorhinolaryngology, Kecioren Research and Training Hospital, Ankara, Turkey.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Mirici', 'Affiliation': 'Department of Otorhinolaryngology, Kecioren Research and Training Hospital, Ankara, Turkey.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Dagli', 'Affiliation': 'Department of Otorhinolaryngology, Kecioren Research and Training Hospital, Ankara, Turkey.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Acar', 'Affiliation': 'Department of Otorhinolaryngology, Kecioren Research and Training Hospital, Ankara, Turkey.'}]",The Journal of laryngology and otology,['10.1017/S0022215121000967'] 3316,33843490,Effect of education-based workplace intervention (Move-in Office With Education - MOWE) on sedentary behaviour and wellbeing in Desk-Based Workers - A cluster randomized controlled trial.,"The study aimed to assess effectiveness of short-term workplace-based physical activity education on altering sitting outcomes, maximal oxygen consumption and occupational wellbeing. Four office clusters (46 participants) of desk-based workers were randomised to either Move-in office With Education (MOWE) group or the control (CONT) group for four weeks. The outcomes were occupational sedentary time, maximal oxygen consumption ( V O 2 max) and workplace wellbeing. Data were analyzed using non-parametric tests. Our study results did not show any significant change in sitting time or V O 2 max. Nevertheless, workplace wellbeing of MOWE group significantly improved when compared to the CONT group especially in the domains of work satisfaction (odds ratio = 11.67; p = 0.001) and employer care (odds ratio = 0.167; p = 0.001). Workplace education (MOWE) improves wellbeing but may not alter sitting outcomes or V O 2 max in office workers. Workplace education without policy change may not yield positive health outcomes.",2021,"Nevertheless, workplace wellbeing of MOWE group significantly improved when compared to the CONT group especially in the domains of work satisfaction (odds ratio = 11.67; p = 0.001) and employer care (odds ratio = 0.167; p = 0.001).",['Four office clusters (46 participants) of desk-based workers'],"['Move-in office With Education (MOWE) group or the control (CONT', 'CONT', 'Workplace education (MOWE', 'short-term workplace-based physical activity education', 'education-based workplace intervention (Move-in Office With Education - MOWE']","['sedentary behaviour and wellbeing', 'employer care', 'occupational sedentary time, maximal oxygen consumption ( V O 2 max) and workplace wellbeing', 'sitting time or V O 2 max', 'sitting outcomes, maximal oxygen consumption and occupational wellbeing']","[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1274022', 'cui_str': 'Employer'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",46.0,0.109574,"Nevertheless, workplace wellbeing of MOWE group significantly improved when compared to the CONT group especially in the domains of work satisfaction (odds ratio = 11.67; p = 0.001) and employer care (odds ratio = 0.167; p = 0.001).","[{'ForeName': 'Ashwini Kumar', 'Initials': 'AK', 'LastName': 'Patel', 'Affiliation': 'Department of Exercise and Sport Sciences, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Chavinoor', 'Initials': 'C', 'LastName': 'Banga', 'Affiliation': 'Department of Exercise and Sport Sciences, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Baskaran', 'Initials': 'B', 'LastName': 'Chandrasekaran', 'Affiliation': 'Department of Exercise and Sport Sciences, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}]",International journal of occupational safety and ergonomics : JOSE,['10.1080/10803548.2021.1916221'] 3317,33843477,Evaluation of head and cervical spine posture after functional therapy with Twin‑Block and Bionator appliances: A pilot randomized controlled trial.,"OBJECTIVE Evaluation of head and cervical spine posture and estimation of sample size. METHODS Thirty eligible participants who required functional therapy were randomly assigned to the Control group (C), Twin Block group (TB), or the Bionator group (B). Randomization was accomplished by means of blocks of fixed size stratified by sex and age, with the allocations concealed in opaque and sealed envelopes. RESULTS Significant differences were identified between the pre -and post-functional SNB ( p = 0.024) and ANB ( p = 0.034) angles in the Twin Block group and SNA ( p = 0. 019) and ANB ( p = 0. 028) angles in the Bionator group. No statistically significant changes were seen in the head or cervical variables in the three groups. CONCLUSION The functional appliance did not cause any statistical change in head posture or cervical spinal column in comparison with the non-treatment group.",2021,The functional appliance did not cause any statistical change in head posture or cervical spinal column in comparison with the non-treatment group.,['Thirty eligible participants who required functional therapy'],"['Twin‑Block and Bionator appliances', 'Control group (C), Twin Block group (TB']","['head posture or cervical spinal column', 'head or cervical variables', 'ANB']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0005548', 'cui_str': 'Bionator orthodontic appliance'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0041427', 'cui_str': 'Twin sibling'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1536116', 'cui_str': 'Head posture abnormal'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0068053', 'cui_str': 'N-hydroxysuccinimidyl-5-azido-2-nitrobenzoate'}]",30.0,0.0695741,The functional appliance did not cause any statistical change in head posture or cervical spinal column in comparison with the non-treatment group.,"[{'ForeName': 'Hoger Omran', 'Initials': 'HO', 'LastName': 'Alsheikho', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Tishreen University, Latakia, Syria.'}, {'ForeName': 'Doaa Hussain', 'Initials': 'DH', 'LastName': 'Jomah', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Tishreen University, Latakia, Syria.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Younes', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Tishreen University, Latakia, Syria.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Tizini', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Tishreen University, Latakia, Syria.'}, {'ForeName': 'Hazem', 'Initials': 'H', 'LastName': 'Hassan', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Tishreen University, Latakia, Syria.'}, {'ForeName': 'Fadi', 'Initials': 'F', 'LastName': 'Khalil', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Tishreen University, Latakia, Syria.'}]",Cranio : the journal of craniomandibular practice,['10.1080/08869634.2021.1909455'] 3318,33843446,How to strengthen basic competencies in self-care - a pre-post interventional study with postgraduate trainees in Family Medicine in Germany.,"Introduction: Self-care includes taking care of our psychosocial health. Many experts agree that self-care should be included in training for Family Medicine residents (=FM residents), though it is unclear to what extent and by what means. The aim of this study was to evaluate competencies of FM residents in self-care and changes in competencies as well as attitudes after an educational compact intervention. Methods: The authors performed a pre-post comparison in residents who were registered in the FM residency program KWBW VerbundweiterbildungPLUS© (n=401). FM residents were offered voluntary participation within a two-day seminar including 270 minutes on self-care training (featuring a broad spectrum of input and practical experience) in 2018. The intervention group (IG; FM residents who attended the seminar) completed a baseline questionnaire directly before the seminar (T1) and 10 weeks afterwards (T2). Non-attendees (=control group; CG) were asked to fill out a basic questionnaire once. Basic questionnaires for IG and CG covered previous experiences and competencies, while the follow-up questionnaire at T2 also focused on change of competencies and attitudes. In addition to quantitative assessments, all questionnaires contained free-text questions to capture qualitative impressions as well. Results: 287 FM residents (IG: n=212; CG: n=75) participated in the study. Generally, 86.4% of FM residents had worried that their profession might endanger their personal health (T1: n=180, CG: n=68). At T2, 59.5% of IG (n=66/111) declared they would not worry about their personal health anymore (T1:T2, p<.01). IG learned to facilitate time for recreation (T1:T2, p=.04) and to use relaxation techniques (T1:T2, p=.01). Gain in competence was described in awareness of stress, self-reward, activation of personal resources and time-management. 85.6% of IG reflected their attitudes towards psychosocial health of physicians in general (n=95/111) and 22.5% of IG changed the views on their own health (n=25/111) in terms of improved risk-awareness, increased intention for self-care and change of behavior. Conclusion: A compact intervention in self-care strengthens competencies, increases awareness, and helps FM residents identify their psychosocial health risks. Further research is necessary to specify the effects and effectiveness of similar compact interventions in self-care and their long-term-results.",2021,"IG learned to facilitate time for recreation (T1:T2, p=.04) and to use relaxation techniques (T1:T2, p=.01).","['residents who were registered in the FM residency program KWBW VerbundweiterbildungPLUS© (n=401', '287 FM residents (IG: n=212; CG: n=75) participated in the study', 'Family Medicine residents (=FM residents', 'postgraduate trainees in Family Medicine in Germany']",[],"['risk-awareness, increased intention for self-care and change of behavior']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0035182', 'cui_str': 'Residency'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0198679,"IG learned to facilitate time for recreation (T1:T2, p=.04) and to use relaxation techniques (T1:T2, p=.01).","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Schwill', 'Affiliation': 'Department of General Practice and Health Services Research, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Krug', 'Affiliation': 'Department of General Practice and Health Services Research, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Valentini', 'Affiliation': 'Institute of General Practice and Interprofessional Care, University Hospital Tuebingen, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rentschler', 'Affiliation': 'Department of General Practice and Health Services Research, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Nikendei', 'Affiliation': 'Department of General Internal Medicine and Psychosomatics, University of Heidelberg Medical Hospital, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Szecsenyi', 'Affiliation': 'Department of General Practice and Health Services Research, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'Bugaj', 'Affiliation': 'Department of General Internal Medicine and Psychosomatics, University of Heidelberg Medical Hospital, Germany.'}]",Postgraduate medicine,['10.1080/00325481.2021.1916298'] 3319,33843410,Effect of a semi-immersive virtual reality navigation therapy on quality of life in persons with spinal cord injury.,"PURPOSE This study aims to develop a sailing simulation-based therapeutic rehabilitation program for individuals with Spinal Cord Injuries (SCI) during the subacute phase of the injury. METHODS Participants were 11 patients, aged between 20-56 years ( M age = 42.36, SD age =12.90), who were randomly assigned into experimental group and control group, within a pre-test/post-test quasi-experimental design. While both groups followed the rehabilitation programmed by the hospital, experimental group participants were enrolled in an interactive rehabilitation exercise (The vSail-Access®, Virtual Sailing Pty Ltd). For this intervention, each subject underwent a semi-immersive Virtual Reality (VR) navigation therapy for 30-40 min per day, three times per week for six weeks. Quality of life (QoL), functionality and balance variables were measured for both groups one week before and after the intervention. Data was generated based on patients' responses using validated questionnaires and tests. A 2 (groups) × 2 (test-time) MANOVA was performed to detect between-group and within-group differences. RESULTS Significant improvements were obtained in the experimental group in the mobility and balance variables, and in the global result of QoL. CONCLUSIONS The sailing simulation program, included as a therapy within the rehabilitation process after a SCI, provides participants with an overall increase in QoL and functionality.IMPLICATIONS FOR REHABILIATIONVirtual reality is a therapy that can be part of the rehabilitation process of spinal cord injuries in the acute phase, improving functional capacity.The initiation to recreational sailing in a virtual way is a safe tool for the initiation to the practice of sports.The practice of a dynamic sport, such as sailing, helps to improve the quality of life in spinal cord injuries.",2021,"RESULTS Significant improvements were obtained in the experimental group in the mobility and balance variables, and in the global result of QoL. CONCLUSIONS The sailing simulation program, included as a therapy within the rehabilitation process after a SCI, provides participants with an overall increase in QoL and functionality.","['persons with spinal cord injury', 'Participants were 11 patients, aged between 20-56\u2009years ( M age = 42.36, SD age =12.90', 'individuals with Spinal Cord Injuries (SCI) during the subacute phase of the injury']","['interactive rehabilitation exercise (The vSail-Access®, Virtual Sailing Pty Ltd', 'semi-immersive virtual reality navigation therapy', 'semi-immersive Virtual Reality (VR) navigation therapy', 'sailing simulation-based therapeutic rehabilitation program']","['mobility and balance variables', 'QoL and functionality', 'quality of life', 'Quality of life (QoL), functionality and balance variables']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]","[{'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0522727', 'cui_str': 'Sailing'}, {'cui': 'C1136140', 'cui_str': 'Long-Term Depression, Neurophysiologic'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",11.0,0.0123743,"RESULTS Significant improvements were obtained in the experimental group in the mobility and balance variables, and in the global result of QoL. CONCLUSIONS The sailing simulation program, included as a therapy within the rehabilitation process after a SCI, provides participants with an overall increase in QoL and functionality.","[{'ForeName': 'Aarón', 'Initials': 'A', 'LastName': 'Manzanares', 'Affiliation': 'Faculty of Sport, Catholic University of San Antonio (UCAM), Murcia, Spain.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Camblor', 'Affiliation': 'Faculty of Sport, Catholic University of San Antonio (UCAM), Murcia, Spain.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Romero-Arenas', 'Affiliation': 'Faculty of Sport, Catholic University of San Antonio (UCAM), Murcia, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Segado', 'Affiliation': 'Faculty of Sport, Catholic University of San Antonio (UCAM), Murcia, Spain.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Gil-Arias', 'Affiliation': 'Centre for Sport Studies, Rey Juan Carlos University, Fuenlabrada (Madrid), Spain.'}]",Disability and rehabilitation. Assistive technology,['10.1080/17483107.2021.1913520'] 3320,33843404,Efficiency of Topical Rifampin on Infection in Open Neural Tube Defects: A randomized controlled trial.,"Objectives: Neural tube defects are the second most common congenital malformation in humans. Despite significant decreases in neural tube defects and related mortality and morbidity with recent developments, infections remain an important problem. Research on the role of topical therapy for managing neural tube defects and associated infections in the neonatal period has been limited. This randomized controlled trial aimed to investigate the efficiency of topical Rifampin on infection control in paraplegic newborns with open neural tube defects. Methods: Thirty-seven patients who underwent an operation for neural tube defects were included. Topical Rifampin and cefotaxime were administered to 19 patients constituting the case group and local saline and cefotaxime were administered to a control group. Patients were examined for ventriculoperitoneal shunt infection/dysfunction, surgical site infection, urinary tract infection, and sepsis. Results: None of the patients using topical rifampin had ventriculoperitoneal shunt infection/dysfunction, surgical site infection, urinary tract infection, or sepsis. In the control group, ventriculoperitoneal shunt infection/dysfunction was found in 4 (22.2%) cases, surgical site infection in 3 (27.7%), urinary tract infection in 3 (27.7%), and sepsis in 5 (27.7%), with statistically significant differences between the groups (p = 0.01, p = 0.032, p = 0.032, and p = 0.002, respectively). No local or systemic side effect was observed regarding rifampin use. Conclusion: Topical Rifampin is effective in minimizing complications like sepsis, surgical site infection, urinary tract infection, and ventriculoperitoneal shunt infection due to neural tube defect operations. Further research with larger numbers of cases is needed to implement this practice routinely.",2021,"None of the patients using topical rifampin had ventriculoperitoneal shunt infection/dysfunction, surgical site infection, urinary tract infection, or sepsis.","['19 patients constituting the case group and', 'Thirty-seven patients who underwent an operation for neural tube defects were included', 'paraplegic newborns with open neural tube defects', 'Open Neural Tube Defects']","['local saline and cefotaxime', 'topical Rifampin', 'Topical Rifampin and cefotaxime', 'topical rifampin', 'Topical Rifampin']","['sepsis', 'surgical site infection', 'ventriculoperitoneal shunt infection/dysfunction', 'urinary tract infection', 'local or systemic side effect', 'ventriculoperitoneal shunt infection/dysfunction, surgical site infection, urinary tract infection, or sepsis', 'neural tube defects and related mortality and morbidity', 'ventriculoperitoneal shunt infection/dysfunction, surgical site infection, urinary tract infection, and sepsis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0027794', 'cui_str': 'Neural tube defect'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0857021', 'cui_str': 'Paraplegic'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0007554', 'cui_str': 'Cefotaxime'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}]","[{'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0162702', 'cui_str': 'Ventriculoperitoneal shunt'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0027794', 'cui_str': 'Neural tube defect'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",37.0,0.105274,"None of the patients using topical rifampin had ventriculoperitoneal shunt infection/dysfunction, surgical site infection, urinary tract infection, or sepsis.","[{'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Deger', 'Affiliation': 'Dicle University School of Medicine, Department of Pediatric, division of neonatology, Diyarbakir, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Başaranoğlu', 'Affiliation': 'University of Health Sciences, Department of Pediatric, division of neonatology, Van, Turkey.'}, {'ForeName': 'Nihat', 'Initials': 'N', 'LastName': 'Demir', 'Affiliation': 'Esenyurt Private Hospital, Department of Pediatric, division of neonatology, İstanbul, Turkey.'}, {'ForeName': 'Abdurrahman', 'Initials': 'A', 'LastName': 'Aycan', 'Affiliation': 'Yuzuncu Yıl University Faculty of Medicine, Department of Neurosurgery, Van, Turkey.'}, {'ForeName': 'Oğuz', 'Initials': 'O', 'LastName': 'Tuncer', 'Affiliation': 'Yuzuncu Yıl University Faculty of Medicine, division of neonatology, Van, Turkey.'}]",The International journal of neuroscience,['10.1080/00207454.2021.1909583'] 3321,33843370,Reasons for refusing referrals and challenges to effectual engagement in tele-treatment for depression among low-income homebound older adults.,"Objectives: To describe reasons for refusal to be referred to or enroll in a depression treatment study and post-enrollment challenges to treatment engagement and technology-related problems among low-income homebound individuals aged 50+ years with depression. Methods: Data came from a 3-arm randomized clinical trial that evaluated real-world effectiveness of lay counselor-delivered behavioral activation (BA) versus clinician-delivered problem-solving therapy (PST). Interventionists were embedded in a large home-delivered meals program and treatment sessions were videoconferenced; hence Tele-BA and Tele-PST. We described refusal reasons of those who refused initial case manager referrals ( n  = 279), telephone screening ( n  = 64), enrollment ( n  = 47), or post-enrollment baseline assessments ( n  = 18). We used inductive thematic analysis to explore challenges to effectual treatment engagement and tele-delivery-related problems among Tele-PST or Tele-BA participants ( n  = 183) from the interventionists' tele-session process recordings. Results: More than a third of potentially eligible older adults refused their case managers' referral, and a quarter of those who accepted referral refused further screening or enrollment. Three quarters of those who refused reported no interest or need or declined to talk about depression. Others refused given their busy schedule with medical appointments and caregiving. Nearly 80% of Tele-BA or Tele-PST participants had some challenges to effectual engagement in treatment sessions due to environmental and health-related conditions and other life stressors including financial distress. Though many tele-sessions had connectivity and other technology-related problems, these did not affect depression outcomes. Conclusion: Mental health service providers for low-income older adults need to be aware of these challenges when adopting best practice strategies for them.",2021,Nearly 80% of Tele-BA or Tele-PST participants had some challenges to effectual engagement in treatment sessions due to environmental and health-related conditions and other life stressors including financial distress.,"['low-income homebound individuals aged 50+ years with depression', 'Conclusion: Mental health service providers for low-income older adults', 'low-income homebound older adults']","['telephone screening', 'lay counselor-delivered behavioral activation (BA) versus clinician-delivered problem-solving therapy (PST']",[],"[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0242798', 'cui_str': 'Home-Bound Persons'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C1571885', 'cui_str': 'Professional counselor'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}]",[],,0.0880848,Nearly 80% of Tele-BA or Tele-PST participants had some challenges to effectual engagement in treatment sessions due to environmental and health-related conditions and other life stressors including financial distress.,"[{'ForeName': 'Namkee G', 'Initials': 'NG', 'LastName': 'Choi', 'Affiliation': 'Steve Hicks School of Social Work, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Vences', 'Affiliation': 'Steve Hicks School of Social Work, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Julieta', 'Initials': 'J', 'LastName': 'Caamano', 'Affiliation': 'Steve Hicks School of Social Work, University of Texas at Austin, Austin, TX, USA.'}]",Aging & mental health,['10.1080/13607863.2021.1910789'] 3322,33843315,Communication Campaigns to Support the Use of Nutritional Warnings: Different Messages for Different People?,"Communication campaigns are expected to contribute to increase the efficacy of nutritional warnings. In this context, the aims of the present work were (a) to evaluate how citizens perceive different types of messages for a communication campaign and (b) to determine if personal characteristics such as gender, age, and educational level, as well socioeconomic and nutritional status, moderate how citizens perceive such campaign messages. A series of graphic pieces were designed for each of the following three types of messages: promotion of informed food choices; raising awareness of the negative health consequences of excessive consumption of sugar, fat, and sodium; and promotion of healthy food choices. An online study was conducted with 774 participants, who were randomly assigned to one of the three types of messages. The participants' self-reported perception of the graphic pieces was evaluated using 7-point Likert-type scales. After completing the evaluation task, the participants proceeded to a series of choices. This was implemented to evaluate whether exposure to different types of messages affected hypothetical food choices. Results revealed that messages related to the promotion of healthy eating were perceived as the most adequate as part of a communication campaign and had the potential to encourage more healthful hypothetical choices in the experimental task. However, gender, age, and nutritional status moderated the influence of the type of message on the participants' perception, meaning that different groups perceived different types of messages as the most adequate. The results from the present work stress the need to include different types of messages in a communication campaign to target individuals with different motivations and characteristics.",2021,"However, gender, age, and nutritional status moderated the influence of the type of message on the participants' perception, meaning that different groups perceived different types of messages as the most adequate.","['774 participants', 'Nutritional Warnings']",[],[],[],[],[],774.0,0.0157081,"However, gender, age, and nutritional status moderated the influence of the type of message on the participants' perception, meaning that different groups perceived different types of messages as the most adequate.","[{'ForeName': 'Gastón', 'Initials': 'G', 'LastName': 'Ares', 'Affiliation': 'Universidad de la República, Pando, Canelones, Uruguay.'}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Vidal', 'Affiliation': 'Universidad de la República, Pando, Canelones, Uruguay.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Otterbring', 'Affiliation': 'Aarhus University, Aarhus V, Denmark.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Aschemann-Witzel', 'Affiliation': 'Aarhus University, Aarhus V, Denmark.'}, {'ForeName': 'María Rosa', 'Initials': 'MR', 'LastName': 'Curutchet', 'Affiliation': 'Instituto Nacional de Alimentacion, Montevideo, Uruguay.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Giménez', 'Affiliation': 'Universidad de la República, Pando, Canelones, Uruguay.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Bove', 'Affiliation': 'UNICEF Uruguay, Montevideo, Uruguay.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/10901981211003510'] 3323,33843297,Physical activity on prescription in patients with hip or knee osteoarthritis: A randomized controlled trial.,"OBJECTIVE To evaluate whether physical activity on prescription, comprising five sessions, was more effective in increasing physical activity than a one-hour advice session after six months. DESIGN Randomized, assessor-blinded, controlled trial. SETTING Primary care. SUBJECTS Patients with clinically verified osteoarthritis of the hip or knee who undertook less than 150 minute/week of moderate physical activity, and were aged 40-74 years. INTERVENTIONS The advice group ( n  = 69) received a one-hour session with individually tailored advice about physical activity. The physical activity on prescription group ( n  = 72) received individually tailored physical activity recommendations with written prescription, and four follow-ups during six months. MAIN MEASURES Patients were assessed at baseline and six months: physical activity (accelerometer, questionnaires); fitness (six-minute walk test, 30-second chair-stand test, maximal step-up test, one-leg rise test); pain after walking (VAS); symptoms (HOOS/KOOS); and health-related quality of life (EQ-5D). RESULTS One hundred four patients had knee osteoarthritis, 102 were women, and mean age was 60.3 ± 8.3 years. Pain after walking decreased significantly more in the prescription group, from VAS 31 ± 22 to 18 ± 23. There was no other between groups difference. Both groups increased self-reported activity minutes significantly, from 105 (95% CI 75-120) to 165 (95% CI 135-218) minute/week in the prescription group versus 75 (95% CI 75-105) to 150 (95% CI 120-225) in the advice group. Also symptoms and quality of life improved significantly in both groups. CONCLUSION Individually tailored physical activity with written prescription and four follow-ups does not materially improve physical activity level more than advice about osteoarthritis and physical activity. TRIAL REGISTRATION ClinicalTrials.gov (NCT02387034).",2021,"Pain after walking decreased significantly more in the prescription group, from VAS 31 ± 22 to 18 ± 23.","['One hundred four patients had knee osteoarthritis, 102 were women, and mean age was 60.3\u2009±\u20098.3\u2009years', 'patients with hip or knee osteoarthritis', 'Patients with clinically verified osteoarthritis of the hip or knee who undertook less than 150\u2009minute/week of moderate physical activity, and were aged 40-74\u2009years']","['individually tailored physical activity recommendations with written prescription, and four follow-ups during six months']","['Pain after walking', 'physical activity (accelerometer, questionnaires); fitness (six-minute walk test, 30-second chair-stand test, maximal step-up test, one-leg rise test); pain after walking (VAS); symptoms (HOOS/KOOS); and health-related quality of life (EQ-5D', 'self-reported activity minutes', 'physical activity', 'symptoms and quality of life', 'Physical activity', 'physical activity level']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0029410', 'cui_str': 'Osteoarthritis of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0556975', 'cui_str': 'mins/week'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4082120', 'cui_str': 'Six months'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0454366', 'cui_str': 'Step ups'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",102.0,0.0589848,"Pain after walking decreased significantly more in the prescription group, from VAS 31 ± 22 to 18 ± 23.","[{'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Bendrik', 'Affiliation': 'Department of Public Health and Caring Sciences/Family Medicine and Preventive Medicine, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Lena V', 'Initials': 'LV', 'LastName': 'Kallings', 'Affiliation': 'Department of Public Health and Caring Sciences/Family Medicine and Preventive Medicine, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Bröms', 'Affiliation': 'Department of Public Health and Caring Sciences/Family Medicine and Preventive Medicine, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Wanlop', 'Initials': 'W', 'LastName': 'Kunanusornchai', 'Affiliation': 'Faculty of Physical Therapy, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Margareta', 'Initials': 'M', 'LastName': 'Emtner', 'Affiliation': 'Department of Neuroscience, Uppsala University, Uppsala, Sweden.'}]",Clinical rehabilitation,['10.1177/02692155211008807'] 3324,33843296,The comparative effects of brief or multidisciplinary intervention on return to work at 1 year in employees on sick leave due to low back pain: A randomized controlled trial.,"OBJECTIVE To compare return to work (RTW) rates among patients with low back pain (LBP) and different job relations randomized to brief or multidisciplinary intervention. DESIGN A randomized controlled trial with 1-year follow-up. SETTING Silkeborg Regional Hospital, Denmark. SUBJECTS Four hundred seventy-six participants were divided into two groups concerning job relations: strong (influence on job and no fear of losing it) or weak (no influence on job and/or fear of losing it), and afterwards randomized to brief or multidisciplinary intervention. INTERVENTIONS Brief intervention included examination and advice by a rheumatologist and a physiotherapist. Multidisciplinary intervention included brief intervention plus coaching by a case manager making a plan for RTW with the patient. MAIN MEASURES Primary outcome was 1-year RTW rate. Secondary outcomes included pain intensity (LBP rating scale), disability (Roland Morris disability scale), and psychological measures (Common Mental Disorder Questionnaire, Major Depression Inventory, and EQ-5D-3L). RESULTS Mean (SD) age was 43.1 (9.8) years. Among 272 participants with strong job relations, RTW was achieved for 104/137 (76%) receiving brief intervention compared to 89/135 (66%) receiving multidisciplinary intervention, hazard ratio 0.73 (CI: 0.55-0.96). Corresponding results for 204 participants with weak job relations were 69/102 (68%) in both interventions, hazard ratio 1.07 (CI: 0.77-1.49). For patients with strong job relations, depressive symptoms and quality of life were more improved after brief intervention. CONCLUSION Brief intervention resulted in higher RTW rates than multidisciplinary intervention for employees with strong job relations. There were no differences in RTW rates between interventions for employees with weak job relations.",2021,"Corresponding results for 204 participants with weak job relations were 69/102 (68%) in both interventions, hazard ratio 1.07 (CI: 0.77-1.49).","['272 participants with strong job relations', '204 participants with weak job relations', 'employees on sick leave due to low back pain', 'Silkeborg Regional Hospital, Denmark', 'Four hundred seventy-six participants', 'patients with low back pain (LBP']","['intervention plus coaching by a case manager making a plan for RTW with the patient', 'job relations: strong (influence on job and no fear of losing it) or weak (no influence on job and/or fear of losing it), and afterwards randomized to brief or multidisciplinary intervention', 'Brief intervention included examination and advice by a rheumatologist and a physiotherapist', 'multidisciplinary intervention']","['return to work (RTW) rates', 'depressive symptoms and quality of life', 'RTW rates', 'higher RTW rates', 'pain intensity (LBP rating scale), disability (Roland Morris disability scale), and psychological measures (Common Mental Disorder Questionnaire, Major Depression Inventory, and EQ-5D-3L', '1-year RTW rate']","[{'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C1762617', 'cui_str': 'Weak'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0687694', 'cui_str': 'Case manager'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0334889', 'cui_str': 'Rheumatologist'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}]","[{'cui': 'C0425105', 'cui_str': 'Returned to work'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0439234', 'cui_str': 'year'}]",476.0,0.0840491,"Corresponding results for 204 participants with weak job relations were 69/102 (68%) in both interventions, hazard ratio 1.07 (CI: 0.77-1.49).","[{'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Langagergaard', 'Affiliation': 'Diagnostic Center, University Research Clinic for Innovative Patient Pathways, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Ole Kudsk', 'Initials': 'OK', 'LastName': 'Jensen', 'Affiliation': 'Diagnostic Center, University Research Clinic for Innovative Patient Pathways, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Claus Vinther', 'Initials': 'CV', 'LastName': 'Nielsen', 'Affiliation': 'Department of Clinical Social Medicine and Rehabilitation, Gødstrup Hospital, Herning, Denmark.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Jensen', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Labriola', 'Affiliation': 'Norwegian Research Center A/S, Bergen, Norway.'}, {'ForeName': 'Vibeke Neergaard', 'Initials': 'VN', 'LastName': 'Sørensen', 'Affiliation': 'Diagnostic Center, University Research Clinic for Innovative Patient Pathways, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Pedersen', 'Affiliation': 'Section of Clinical Social Medicine and Rehabilitation, Department of Public Health, Aarhus University, Aarhus, Denmark.'}]",Clinical rehabilitation,['10.1177/02692155211005387'] 3325,33843245,Multi-institutional Prospective Randomized Control Trial of Novel Intracorporeal Lithotripters: ShockPulse-SE vs TrilogyTM Trial.,"INTRODUCTION Currently, there are multiple intracorporeal lithotripters available for use in percutaneous nephrolithotomy (PCNL). This study aimed to evaluate the efficiency of two novel lithotripters; TrilogyTM and ShockPulse-SE. METHODS This is a prospective, multi-institutional, randomized trial comparing outcomes of PCNL using two novel lithotripters between February 2019 and June 2020. The study assessed objective measures of stone clearance time, stone clearance rate, device malfunction, stone-free rates, and complications. Device assessment was provided via immediate postoperative survey by primary surgeons. RESULTS There were 100 standard PCNLs completed using either a TrilogyTM or ShockPulse-SE lithotrite. Using quantitative Stone Analysis Software to estimate stone volume, the mean stone volume was calculated at 4.18 ± 4.79 cm3 and 3.86 ± 3.43 cm3 for the Trilogy and ShockPulse-SE groups respectively . Stone clearance rates were found to be 1.22 ± 1.67 and 0.77 ± 0.68 cm3/min for TrilogyTM versus ShockPulse-SE (p=0.0542). When comparing TrilogyTM to ShockPulse-SE in a multivariate analysis, total OR time (104.4 ± 48.2 vs 121.1 ± 59.2 min p=0.126), rates of secondary procedures (17.65% vs 40.81% p=0.005), and device malfunctions (1.96% vs 34.69% p<0.001), were less, respectively. There was no difference in final stone free rates between devices. CONCLUSION The TrilogyTM lithotripter removed stones significantly faster than previous generations of intracorporeal lithotripters. In the case of large stones the efficiency of the TrilogyTM device optimizes clearance and operating times.",2021,The TrilogyTM lithotripter removed stones significantly faster than previous generations of intracorporeal lithotripters.,['using two novel lithotripters between February 2019 and June 2020'],"['novel lithotripters; TrilogyTM and ShockPulse-SE', 'PCNL', 'TrilogyTM or ShockPulse-SE lithotrite', 'percutaneous nephrolithotomy (PCNL']","['final stone free rates', 'rates of secondary procedures', 'mean stone volume', 'device malfunctions', 'Stone clearance rates', 'total OR time', 'stone clearance time, stone clearance rate, device malfunction, stone-free rates, and complications']","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0181670', 'cui_str': 'Lithotripter'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0181670', 'cui_str': 'Lithotripter'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0181679', 'cui_str': 'Lithotrite'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0445275', 'cui_str': 'Secondary procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1504465', 'cui_str': 'Device malfunction'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0561753,The TrilogyTM lithotripter removed stones significantly faster than previous generations of intracorporeal lithotripters.,"[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Large', 'Affiliation': 'Indiana University School of Medicine, 12250, Urology, 1801 N Senate Blvd, Suite 220, Indianapolis, Indiana, United States, 46202; timlarge@iupui.edu.'}, {'ForeName': 'Charles Upshur', 'Initials': 'CU', 'LastName': 'Nottingham', 'Affiliation': 'Indiana University School of Medicine, Urology, 1701 North Senate Avenue, Indianapolis, Indiana, United States, 46202; cunottingham@gmail.com.'}, {'ForeName': 'John Ethan', 'Initials': 'JE', 'LastName': 'Brinkman', 'Affiliation': 'Indiana University School of Medicine, 12250, Urology, 535 Barnhill Drive, IU Simon Comprehensive Cancer Center 150, Indianapolis, Indiana, United States, 46202-5114; jebrinkm@iu.edu.'}, {'ForeName': 'Deepak Kumar', 'Initials': 'DK', 'LastName': 'Agarwal', 'Affiliation': 'Indiana University School of Medicine, Urology, Indianapolis, Indiana, United States; dkagarwa@iu.edu.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ferrero', 'Affiliation': 'Mayo Clinic, 6915, Rochester, Minnesota, United States; ferrero.andrea@mayo.edu.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Sourial', 'Affiliation': 'Ohio State University Wexner Medical Center, 12306, Department of Urology, 915 Olentangy River Road, Suite 3100, Columbus, Ohio, United States, 43212; Michael.Sourial@osumc.edu.'}, {'ForeName': 'Karen Lynne', 'Initials': 'KL', 'LastName': 'Stern', 'Affiliation': 'Cleveland Clinic Foundation, Urology, 9500 Euclid Avenue, Q10-1, Cleveland, Ohio, United States, 44195; Stern.Karen@mayo.edu.'}, {'ForeName': 'Marcelino E', 'Initials': 'ME', 'LastName': 'Rivera', 'Affiliation': 'Indiana University Health Methodist Hospital, 22535, Urology, 1801 Senate Blvd, Ste 220, Indianapolis, Indiana, United States, 46202; mrivera7@iuhealth.org.'}, {'ForeName': 'Bodo E', 'Initials': 'BE', 'LastName': 'Knudsen', 'Affiliation': 'Ohio State University Medical Center, Department of Surgery, Division of Urology, 4833 University Hospitals Clinic, 456 West 10th Avenue, 915 Olentangy River Road, Columbus, Ohio, United States, 43212; bodo.knudsen@osumc.edu.'}, {'ForeName': 'Mitchell R', 'Initials': 'MR', 'LastName': 'Humphreys', 'Affiliation': 'Mayo Clinic, Department of Urology, 5777 E Mayo Blvd, Phoenix, Arizona, United States, 85054.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Krambeck', 'Affiliation': 'Indiana University School of Medicine, 12250, Urology, 1801 Senate Blvd. #220, Indianapolis, Indiana, United States, 46202; gecoots2@gmail.com.'}]",Journal of endourology,['10.1089/end.2020.1097'] 3326,33843086,Is a 20 gauge fenestrated intravenous catheter non-inferior to a 18 gauge standard catheter for apheresis procedures? A pilot study.,"BACKGROUND Peripheral venous access has been promoted as the safest, quickest, and most easily achievable route for performing apheresis procedures by the American Society for Apheresis' Choosing Wisely campaign. The current literature regarding catheter size and selection for both draw and return access is limited. Furthermore, the Infusion Nurses Society recommends using the smallest gauge catheter possible for the prescribed therapy in order to limit vein trauma and phlebitis. Since there is a lack of evidence to guide selection of catheter size for return access during therapeutic apheresis procedures (TAPs) for patients with chronic conditions, this pilot study seeks to compare the performance of a 20-gauge fenestrated (20G) catheter to a standard 18-gauge (18G) intravenous catheter. METHODS This non-inferiority pilot study randomized 26 subjects during 74 TAPs to either 20G fenestrated catheter or 18G standard catheter. RESULTS There were no statistically significant differences for variables associated with the efficiency of the TAPs comparing 20G to 18G catheter for inlet rate (P = .8666), return pressure (P = .9427), blood processed (P = .4318), or total procedure time (P = .3184). CONCLUSION The results from this pilot study suggest that 20G fenestrated catheter is non-inferior to 18G standard catheters. Additional studies with increased power are warranted to confirm these findings.",2021,"There were no statistically significant differences for variables associated with the efficiency of the TAPs comparing 20G to 18G catheter for inlet rate (P = .8666), return pressure (P = .9427), blood processed (P = .4318), or total procedure time (P = .3184). ","['26 subjects during 74 TAPs to either 20', 'patients with chronic conditions']",['G fenestrated catheter or 18G standard catheter'],"['return pressure', 'total procedure time']","[{'cui': 'C0005791', 'cui_str': 'Apheresis'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0456637', 'cui_str': '18G'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",26.0,0.0417274,"There were no statistically significant differences for variables associated with the efficiency of the TAPs comparing 20G to 18G catheter for inlet rate (P = .8666), return pressure (P = .9427), blood processed (P = .4318), or total procedure time (P = .3184). ","[{'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Armendariz', 'Affiliation': 'Apheresis Clinic, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'West', 'Affiliation': 'Apheresis Clinic, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'DaiWai M', 'Initials': 'DM', 'LastName': 'Olson', 'Affiliation': 'Apheresis Clinic, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Sonja E', 'Initials': 'SE', 'LastName': 'Stutzman', 'Affiliation': 'Apheresis Clinic, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'De Simone', 'Affiliation': 'Apheresis Clinic, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}]",Journal of clinical apheresis,['10.1002/jca.21900'] 3327,33843073,The impact of a mother-infant intervention on parenting and infant response to challenge: A pilot randomized controlled trial with adolescent mothers in El Salvador.,"A pilot randomized controlled trial (RCT) was conducted in El Salvador of an intervention ('Thula Sana') previously shown to enhance maternal sensitivity and infant security of attachment in a South African sample. In El Salvador, trained community workers delivered the intervention from late pregnancy to 6 months postpartum as part of a home-visiting programme. The sample comprised 64 pregnant adolescent women, aged 14-19 years, living in predominantly rural settings. They were randomised to receive either the intervention or normal care. Demographic information was collected at baseline and, immediately post-intervention, blind assessments were made of parental sensitivity and infant emotion regulation. The intervention was found to have a substantial positive impact on maternal sensitivity. Further, compared to control group, infants in the intervention group showed more regulated behaviour: in a social challenge task they showed more attempts to restore communication, and in a non-social challenge task they showed more social and goal-directed behaviour. This replication and extension of the South African findings in a small El Salvador sample shows promise and justifies the conduct of a large-scale RCT in a Central or South American context.",2021,"Further, compared to control group, infants in the intervention group showed more regulated behaviour: in a social challenge task they showed more attempts to restore communication, and in a non-social challenge task they showed more social and goal-directed behaviour.","['64 pregnant adolescent women, aged 14-19 years, living in predominantly rural settings', 'adolescent mothers in El Salvador']",['mother-infant intervention'],"['social and goal-directed behaviour', 'parental sensitivity and infant emotion regulation', 'Demographic information', 'regulated behaviour', 'maternal sensitivity']","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0013754', 'cui_str': 'El Salvador'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0851285', 'cui_str': 'Regulation'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]",64.0,0.0729169,"Further, compared to control group, infants in the intervention group showed more regulated behaviour: in a social challenge task they showed more attempts to restore communication, and in a non-social challenge task they showed more social and goal-directed behaviour.","[{'ForeName': 'Jimena', 'Initials': 'J', 'LastName': 'Valades', 'Affiliation': 'International Planned Parenthood Federation, Western Hemisphere Region (IPPF/WHR), New York, New York, USA.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Murray', 'Affiliation': 'Department of Psychology and Clinical Language Sciences, University of Reading, Reading, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bozicevic', 'Affiliation': 'Institute of Life and Human Sciences, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'De Pascalis', 'Affiliation': 'Institute of Life and Human Sciences, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Florencia', 'Initials': 'F', 'LastName': 'Barindelli', 'Affiliation': 'International Planned Parenthood Federation, Western Hemisphere Region (IPPF/WHR), New York, New York, USA.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Meglioli', 'Affiliation': 'International Planned Parenthood Federation, Western Hemisphere Region (IPPF/WHR), New York, New York, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychology and Clinical Language Sciences, University of Reading, Reading, UK.'}]",Infant mental health journal,['10.1002/imhj.21917'] 3328,33842996,Clinical and radiographic effects of ascorbic acid-augmented platelet-rich fibrin versus platelet-rich fibrin alone in intra-osseous defects of stage-III periodontitis patients: a randomized controlled clinical trial.,"AIM To assess platelet-rich fibrin (PRF) with ascorbic acid (AA) versus PRF in intra-osseous defects of stage-III periodontitis patients. METHODOLOGY Twenty stage-III/grade C periodontitis patients, with ≥ 3 mm intra-osseous defects, were randomized into test (open flap debridement (OFD)+AA/PRF; n = 10) and control (OFD+PRF; n = 10). Clinical attachment level (CAL; primary outcome), probing pocket depth (PPD), gingival recession depth (RD), full-mouth bleeding scores (FMBS), full-mouth plaque scores (FMPS), radiographic linear defect depth (RLDD) and radiographic defect bone density (RDBD) (secondary-outcomes) were examined at baseline, 3 and 6 months post-surgically. RESULTS OFD+AA/PRF and OFD+PRF demonstrated significant intragroup CAL gain and PPD reduction at 3 and 6 months (p < 0.001). OFD+AA/PRF and OFD+PRF showed no differences regarding FMBS or FMPS (p > 0.05). OFD+AA/PRF demonstrated significant RD reduction of 0.90 ± 0.50 mm and 0.80 ± 0.71 mm at 3 and 6 months, while OFD+PRF showed RD reduction of 0.10 ± 0.77 mm at 3 months, with an RD-increase of 0.20 ± 0.82 mm at 6 months (p < 0.05). OFD+AA/PRF and OFD+PRF demonstrated significant RLDD reduction (2.29 ± 0.61 mm and 1.63 ± 0.46 mm; p < 0.05) and RDBD-increase (14.61 ± 5.39% and 12.58 ± 5.03%; p > 0.05). Stepwise linear regression analysis showed that baseline RLDD and FMBS at 6 months were significant predictors of CAL reduction (p < 0.001). CONCLUSIONS OFD+PRF with/without AA significantly improved periodontal parameters 6 months post-surgically. Augmenting PRF with AA additionally enhanced gingival tissue gain and radiographic defect fill. CLINICAL RELEVANCE PRF, with or without AA, could significantly improve periodontal parameters. Supplementing PRF with AA could additionally augment radiographic linear defect fill and reduce gingival recession depth.",2021,"RESULTS OFD+AA/PRF and OFD+PRF demonstrated significant intragroup CAL gain and PPD reduction at 3 and 6 months (p < 0.001).","['Twenty stage-III/grade C periodontitis patients, with ≥ 3 mm intra-osseous defects', 'intra-osseous defects of stage-III periodontitis patients', 'stage-III periodontitis patients']","['ascorbic acid-augmented platelet-rich fibrin versus platelet-rich fibrin alone', 'platelet-rich fibrin (PRF) with ascorbic acid (AA) versus PRF', 'test (open flap debridement (OFD)+AA/PRF; n = 10) and control (OFD+PRF']","['periodontal parameters', 'RLDD reduction', 'RDBD-increase', 'CAL reduction', 'FMBS or FMPS', 'gingival tissue gain and radiographic defect fill', 'Clinical attachment level (CAL; primary outcome), probing pocket depth (PPD), gingival recession depth (RD), full-mouth bleeding scores (FMBS), full-mouth plaque scores (FMPS), radiographic linear defect depth (RLDD) and radiographic defect bone density (RDBD) (secondary-outcomes', 'gingival recession depth', 'intragroup CAL gain and PPD reduction']","[{'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0441807', 'cui_str': 'Grade C'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0015982', 'cui_str': 'Fibrin'}]","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0029464', 'cui_str': 'Osteosclerosis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0221732', 'cui_str': 'Mouth plaque'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C0333047', 'cui_str': 'Recession'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",,0.160878,"RESULTS OFD+AA/PRF and OFD+PRF demonstrated significant intragroup CAL gain and PPD reduction at 3 and 6 months (p < 0.001).","[{'ForeName': 'Mohamed Talaat', 'Initials': 'MT', 'LastName': 'Elbehwashy', 'Affiliation': 'Oral Medicine and Periodontology Department, Faculty of Dentistry, Cairo University, Al Saraya Str. 11, Manial, Cairo, Egypt.'}, {'ForeName': 'Manal Mohamed', 'Initials': 'MM', 'LastName': 'Hosny', 'Affiliation': 'Oral Medicine and Periodontology Department, Faculty of Dentistry, Cairo University, Al Saraya Str. 11, Manial, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elfana', 'Affiliation': 'Oral Medicine and Periodontology Department, Faculty of Dentistry, Cairo University, Al Saraya Str. 11, Manial, Cairo, Egypt.'}, {'ForeName': 'Alaa', 'Initials': 'A', 'LastName': 'Nawar', 'Affiliation': 'Oral and Maxillofacial Radiology Department, Faculty of Dentistry, Cairo University, Giza, Egypt.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fawzy El-Sayed', 'Affiliation': 'Oral Medicine and Periodontology Department, Faculty of Dentistry, Cairo University, Al Saraya Str. 11, Manial, Cairo, Egypt. karim.fawzy@gmail.com.'}]",Clinical oral investigations,['10.1007/s00784-021-03929-1'] 3329,33842993,"Correction to: A Non-inferiority, Randomized Clinical Trial Comparing Paclitaxel-Coated Balloon Versus New-Generation Drug-Eluting Stents on Angiographic Outcomes for Coronary De Novo Lesions.",,2021,,[],['Paclitaxel-Coated Balloon Versus New-Generation Drug-Eluting Stents'],[],[],"[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}]",[],,0.194066,,"[{'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': ""Department of Cardiology, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, 100730, Beijing, People's Republic of China.""}, {'ForeName': 'Xinyue', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Cardiology, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, 100730, Beijing, People's Republic of China.""}, {'ForeName': 'Fusui', 'Initials': 'F', 'LastName': 'Ji', 'Affiliation': ""Department of Cardiology, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, 100730, Beijing, People's Republic of China. jifusuivip@126.com.""}, {'ForeName': 'Wenduo', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Cardiology, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, 100730, Beijing, People's Republic of China.""}, {'ForeName': 'Chenguang', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': ""Department of Cardiology, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, 100730, Beijing, People's Republic of China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': ""Department of Cardiology, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, 100730, Beijing, People's Republic of China.""}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': ""Department of Cardiology, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, 100730, Beijing, People's Republic of China.""}]",Cardiovascular drugs and therapy,['10.1007/s10557-021-07183-1'] 3330,33842984,Ultracongruent insert design is a safe alternative to posterior cruciate-substituting total knee arthroplasty: 5-year results of a randomized controlled trial.,"PURPOSE If substitution of the posterior cruciate ligament in total knee arthroplasty is necessary, there are two options available: posterior stabilized (PS) design with a post-cam mechanism or anterior-lipped ultracongruent (UC) inserts. UC inserts have the advantage that no femoral box is necessary and a standard femoral component can be used. The aim of this study was to compare the range of motion (ROM) and patient-reported outcome (PRO) after UC and PS fixed-bearing TKA. Better ROM in PS TKA and no difference in PRO between both designs was hypothesized. METHODS A randomized controlled trial with 127 patients receiving a fixed-bearing UC or PS design of the same knee system was performed. Nine patients died and there were four revision surgeries. 107 patients completed the 5-year follow-up. Patient-reported outcome was assessed. Patellofemoral problems were evaluated using selected applicable questions of the Oxford Knee Score (getting up from a table, kneeling, climbing stairs). RESULTS Surgical time was 10 min shorter in the UC group (p < 0.001). After 5 years, both groups demonstrated good knee function and health-related quality of life without significant differences between the groups. Both groups demonstrated a high satisfaction score and the majority of patients would undergo this surgery again. Patellofemoral problems were recognized more frequently in the PS group (p = 0.025). CONCLUSION Both designs demonstrated similar good results after 5 years. Stabilization with an anterior-lipped UC insert can be considered a safe alternative to the well-established PS design if cruciate substitution is necessary. LEVEL OF EVIDENCE 1.",2021,"After 5 years, both groups demonstrated good knee function and health-related quality of life without significant differences between the groups.","['posterior cruciate ligament in total knee arthroplasty', '107 patients completed the 5-year follow-up', 'posterior cruciate-substituting total knee arthroplasty', '127 patients receiving a fixed-bearing UC or PS design of the same knee system was performed']",['UC and PS fixed-bearing TKA'],"['PRO', 'good knee function and health-related quality of life', 'range of motion (ROM', 'Patellofemoral problems', 'Surgical time']","[{'cui': 'C0080039', 'cui_str': 'Structure of posterior cruciate ligament of knee joint'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}]","[{'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}]",127.0,0.0506991,"After 5 years, both groups demonstrated good knee function and health-related quality of life without significant differences between the groups.","[{'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Lützner', 'Affiliation': 'University Center of Orthopaedic, Trauma and Plastic Surgery, University Hospital Carl Gustav Carus, TU Dresden, Fetscherstr. 74, 01307, Dresden, Germany. Joerg.Luetzner@ukdd.de.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Beyer', 'Affiliation': 'University Center of Orthopaedic, Trauma and Plastic Surgery, University Hospital Carl Gustav Carus, TU Dresden, Fetscherstr. 74, 01307, Dresden, Germany.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Lützner', 'Affiliation': 'University Center of Orthopaedic, Trauma and Plastic Surgery, University Hospital Carl Gustav Carus, TU Dresden, Fetscherstr. 74, 01307, Dresden, Germany.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Riedel', 'Affiliation': 'University Center of Orthopaedic, Trauma and Plastic Surgery, University Hospital Carl Gustav Carus, TU Dresden, Fetscherstr. 74, 01307, Dresden, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Tille', 'Affiliation': 'University Center of Orthopaedic, Trauma and Plastic Surgery, University Hospital Carl Gustav Carus, TU Dresden, Fetscherstr. 74, 01307, Dresden, Germany.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-021-06545-4'] 3331,33842981,Effect of vestibular rehabilitation on change in health-related quality of life in patients with dizziness and balance problems after traumatic brain injury: A randomized controlled trial.,"OBJECTIVE Secondary analysis, testing the effect on change in health-related quality of life of group-based vestibular rehabilitation in patients with mild-moderate traumatic brain injury, dizziness and -balance problems. DESIGN A single-blind randomized controlled trial. SUBJECTS A total of 65 patients aged 16-60 years with a Rivermead Post-concussion Symptoms Questionnaire dizziness score ≥ 2, and Dizziness Handicap Inventory score > 15 points. Data collection was performed at baseline 3.5 (standard deviation (SD) 2.1) months post-injury, end of intervention, and 4.4 (SD 1.0) months after baseline. METHODS Quality of Life after Brain Injury was the main outcome. Independent variables were demographic and injury variables, Hospital Anxiety and Depression Scale, changes on the Rivermead Post-concussion Symptoms Questionnaire (RPQ3 physical and RPQ13 psychological/cognitive), and Vertigo Symptom Scale-Short Form. RESULTS Mean age of participants was 39.4 years (SD 13.0); 70.3% women. Predictors of change in the Quality of Life after Brain Injury were receiving the vestibular rehabilitation (p = 0.049), baseline psychological distress (p = 0.020), and change in RPQ3 physical (p = 0.047) and RPQ13 psychological/cognitive (p = 0.047). Adjusted R2 was 0.399, F=6.13, p < 0.001. CONCLUSION There was an effect in favour of the intervention group in improvement in health-related quality of life. Changes on the Rivermead Post-concussion Symptoms Questionnaire were also associated with change on the Quality of Life after Brain Injury.",2021,"Predictors of change in the Quality of Life after Brain Injury were receiving the vestibular rehabilitation (p = 0.049), baseline psychological distress (p = 0.020), and change in RPQ3 physical (p = 0.047) and RPQ13 psychological/cognitive (p = 0.047).","['Mean age of participants was 39.4 years (SD 13.0); 70.3% women', 'patients with mild-moderate traumatic brain injury, dizziness and -balance problems', 'patients with dizziness and balance problems after traumatic brain injury', 'A total of 65 patients aged 16-60 years with a Rivermead Post-concussion Symptoms Questionnaire dizziness score ≥\u20092, and Dizziness Handicap Inventory score >\u200915 points']",['vestibular rehabilitation'],"['health-related quality of life', 'baseline psychological distress', 'RPQ13 psychological/cognitive', 'Quality of Life', 'Quality of Life after Brain Injury', 'demographic and injury variables, Hospital Anxiety and Depression Scale, changes on the Rivermead Post-concussion Symptoms Questionnaire (RPQ3 physical and RPQ13 psychological/cognitive), and Vertigo Symptom Scale-Short Form', 'change in RPQ3 physical']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0575090', 'cui_str': 'Balance disorder'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0546983', 'cui_str': 'Postconcussion syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4304791', 'cui_str': 'Dizziness Handicap Inventory score'}]","[{'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0546983', 'cui_str': 'Postconcussion syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",65.0,0.159778,"Predictors of change in the Quality of Life after Brain Injury were receiving the vestibular rehabilitation (p = 0.049), baseline psychological distress (p = 0.020), and change in RPQ3 physical (p = 0.047) and RPQ13 psychological/cognitive (p = 0.047).","[{'ForeName': 'Helene L', 'Initials': 'HL', 'LastName': 'Søberg', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Ulleval University Hospital, NO-0407 Oslo, Norway. E-mail: h.l.soberg@medisin.uio.no, helus@oslomet.no.'}, {'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Andelic', 'Affiliation': ''}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Langhammer', 'Affiliation': ''}, {'ForeName': 'Anne-Lise', 'Initials': 'AL', 'LastName': 'Tamber', 'Affiliation': ''}, {'ForeName': 'Kari A', 'Initials': 'KA', 'LastName': 'Bruusgaard', 'Affiliation': ''}, {'ForeName': 'Ingerid', 'Initials': 'I', 'LastName': 'Kleffelgaard', 'Affiliation': ''}]",Journal of rehabilitation medicine,['10.2340/16501977-2823'] 3332,33842978,Meta Salud Diabetes for cardiovascular disease prevention in Mexico: a cluster-randomized behavioural clinical trial.,"BACKGROUND Healthy lifestyle interventions offered at points of care, including support groups, may improve chronic disease management, especially in low-resource populations. We assessed the effectiveness of an educational intervention in type 2 diabetes (T2D) support groups to reduce cardiovascular disease (CVD) risk. METHODS We recruited 518 participants to a parallel, two-arm, cluster-randomized, behavioural clinical trial across 22 clinics in Sonora, Mexico, between August 2016 and October 2018. We delivered a 13-week secondary prevention intervention, Meta Salud Diabetes (MSD), within the structure of a support group (GAM: Grupo de Ayuda Mutua) in government-run (community) Health Centres (Centros de Salud). The primary study outcomes were difference in Framingham CVD risk scores and hypertension between intervention (GAM+MSD) and control (GAM usual care) arms at 3 and 12 months. RESULTS CVD risk was 3.17% age-points lower in the MSD arm versus control at 3 months [95% confidence interval (CI): -5.60, -0.75, P = 0.013); at 12 months the difference was 2.13% age-points (95% CI: -4.60, 0.34, P = 0.088). There was no evidence of a difference in hypertension rates between arms. Diabetes distress was also lower at 3 and 12 months in the MSD arm. Post-hoc analyses showed greater CVD risk reduction among men than women and among participants with HbA1c < 8. CONCLUSIONS MSD contributed to a positive trend in reducing CVD risk in a low-resource setting. This study introduced an evidence-based curriculum that provides T2D self-management strategies for those with controlled T2D (i.e. HbA1c < 8.0) and may improve quality of life.",2021,"Post-hoc analyses showed greater CVD risk reduction among men than women and among participants with HbA1c < 8. ","['518 participants to a parallel, two-arm, cluster-randomized, behavioural clinical trial across 22 clinics in Sonora, Mexico, between August 2016 and October 2018', 'Mexico']","['educational intervention', '13-week secondary prevention intervention, Meta Salud Diabetes (MSD), within the structure of a support group (GAM: Grupo de']","['CVD risk reduction', 'cardiovascular disease (CVD) risk', 'quality of life', 'CVD risk', 'hypertension rates', 'Diabetes distress', 'Framingham CVD risk scores and hypertension between intervention (GAM+MSD) and control (GAM usual care) arms at 3 and 12\u2009months']","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0679699', 'cui_str': 'Secondary prevention'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0061057', 'cui_str': 'gamma-glutamylaminomethylsulfonic acid'}]","[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0061057', 'cui_str': 'gamma-glutamylaminomethylsulfonic acid'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",518.0,0.188494,"Post-hoc analyses showed greater CVD risk reduction among men than women and among participants with HbA1c < 8. ","[{'ForeName': 'Cecilia B', 'Initials': 'CB', 'LastName': 'Rosales', 'Affiliation': 'Division of Public Health Practice & Translational Research, University of Arizona Mel & Enid Zuckerman College of Public Health, Phoenix, AZ, USA.'}, {'ForeName': 'Catalina A', 'Initials': 'CA', 'LastName': 'Denman', 'Affiliation': 'Centro de Estudios en Salud y Sociedad, El Colegio de Sonora, Hermosillo, SN, México.'}, {'ForeName': 'Melanie L', 'Initials': 'ML', 'LastName': 'Bell', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of Arizona Mel & Enid Zuckerman College of Public Health, Tucson, AZ, USA.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Cornejo', 'Affiliation': 'Centro de Estudios en Salud y Sociedad, El Colegio de Sonora, Hermosillo, SN, México.'}, {'ForeName': 'Maia', 'Initials': 'M', 'LastName': 'Ingram', 'Affiliation': 'Department of Health Promotion Sciences, University of Arizona Mel & Enid Zuckerman College of Public Health, Tucson, AZ, USA.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Del Carmen Castro Vásquez', 'Affiliation': 'Centro de Estudios en Salud y Sociedad, El Colegio de Sonora, Hermosillo, SN, México.'}, {'ForeName': 'Jesús Eduardo', 'Initials': 'JE', 'LastName': 'Gonzalez-Fagoaga', 'Affiliation': 'Division of Public Health Practice & Translational Research, University of Arizona Mel & Enid Zuckerman College of Public Health, Phoenix, AZ, USA.'}, {'ForeName': 'Benjamín', 'Initials': 'B', 'LastName': 'Aceves', 'Affiliation': 'Department of Health Promotion Sciences, University of Arizona Mel & Enid Zuckerman College of Public Health, Tucson, AZ, USA.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Nuño', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of Arizona Mel & Enid Zuckerman College of Public Health, Tucson, AZ, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Anderson', 'Affiliation': 'Department of Health Promotion Sciences, University of Arizona Mel & Enid Zuckerman College of Public Health, Tucson, AZ, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Guernsey de Zapien', 'Affiliation': 'Department of Health Promotion Sciences, University of Arizona Mel & Enid Zuckerman College of Public Health, Tucson, AZ, USA.'}]",International journal of epidemiology,['10.1093/ije/dyab072'] 3333,33842907,"Effect of selenium supplementation on musculoskeletal health in older women: a randomised, double-blind, placebo-controlled trial.","Background Observational and preclinical studies show associations between selenium status, bone health, and physical function. Most adults in Europe have serum selenium below the optimum range. We hypothesised that selenium supplementation could reduce pro-resorptive actions of reactive oxygen species on osteoclasts and improve physical function. Methods We completed a 6-month randomised, double-blind, placebo-controlled trial. We recruited postmenopausal women older than 55 years with osteopenia or osteoporosis at the Northern General Hospital, Sheffield, UK. Participants were randomly assigned 1:1:1 to receive selenite 200 μg, 50 μg, or placebo orally once per day. Medication was supplied to the site blinded and numbered by a block randomisation sequence with a block size of 18, and participants were allocated medication in numerical order. All participants and study team were masked to treatment allocation. The primary endpoint was urine N-terminal cross-linking telopeptide of type I collagen (NTx, expressed as ratio to creatinine) at 26 weeks. Analysis included all randomly assigned participants who completed follow-up. Groups were compared with analysis of covariance with Hochberg testing. Secondary endpoints were other biochemical markers of bone turnover, bone mineral density, short physical performance battery, and grip strength. Mechanistic endpoints were glutathione peroxidase, highly sensitive C-reactive protein, and interleukin-6. This trial is registered with EU clinical trials, EudraCT 2016-002964-15, and ClinicalTrials.gov, NCT02832648, and is complete. Findings 120 participants were recruited between Jan 23, 2017, and April 11, 2018, and randomly assigned to selenite 200 μg, 50 μg, or placebo (n=40 per group). 115 (96%) of 120 participants completed follow-up and were included in the primary analysis (200 μg [n=39], 50 μg [n=39], placebo [n=37]). Median follow-up was 25·0 weeks (IQR 24·7-26·0). In the 200 μg group, mean serum selenium increased from 78·8 (95% CI 73·5-84·2) to 105·7 μg/L (99·5-111·9). Urine NTx to creatinine ratio (nmol bone collagen equivalent:mmol creatinine) did not differ significantly between treatment groups at 26 weeks: 40·5 (95% CI 34·9-47·0) for placebo, 43·4 (37·4-50·5) for 50 μg, and 42·2 (37·5-47·6) for 200 μg. None of the secondary or mechanistic endpoint measurements differed between treatment groups at 26 weeks. Seven (6%) of 120 participants were withdrawn from treatment at week 13 due to abnormal thyroid-stimulating hormone concentrations (one in the 200 μg group, three in the 50 μg group, and three in the placebo group) and abnormal blood glucose (one in the 50 μg group). There were three serious adverse events: a non-ST elevation myocardial infarction at week 18 (in the 50 μg group), a diagnosis of bowel cancer after routine population screening at week 2 (in the placebo group), and a pulmonary embolus due to metastatic bowel cancer at week 4 (in the 200 μg group). All severe adverse events were judged by the principal investigator as unrelated to trial medication. Interpretation Selenium supplementation at these doses does not affect musculoskeletal health in postmenopausal women. Funding UK National Institute for Health Research Efficacy and Mechanism Evaluation programme.",2021,"Urine NTx to creatinine ratio (nmol bone collagen equivalent:mmol creatinine) did not differ significantly between treatment groups at 26 weeks: 40·5 (95% CI 34·9-47·0) for placebo, 43·4 (37·4-50·5) for 50 μg, and 42·2 (37·5-47·6) for 200 μg.","['115 (96%) of 120 participants completed follow-up and were included in the primary analysis (200 μg [n=39], 50 μg [n=39], placebo [n=37', 'older women', 'postmenopausal women older than 55 years with osteopenia or osteoporosis at the Northern General Hospital, Sheffield, UK', 'Findings\n\n\n120 participants were recruited between Jan 23, 2017, and April 11, 2018', 'postmenopausal women']","['selenite 200 μg, 50 μg, or placebo', 'placebo', 'selenium supplementation', 'Selenium supplementation']","['urine N-terminal cross-linking telopeptide of type', 'glutathione peroxidase, highly sensitive C-reactive protein, and interleukin-6', 'mean serum selenium', 'pulmonary embolus due to metastatic bowel cancer', 'Urine NTx to creatinine ratio (nmol bone collagen equivalent:mmol creatinine', 'abnormal blood glucose', 'serious adverse events: a non-ST elevation myocardial infarction', 'All severe adverse events', 'biochemical markers of bone turnover, bone mineral density, short physical performance battery, and grip strength', 'diagnosis of bowel cancer', 'musculoskeletal health']","[{'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0036580', 'cui_str': 'Selenite'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0439822', 'cui_str': 'Highly sensitive'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0858170', 'cui_str': 'Serum selenium'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0346627', 'cui_str': 'Malignant tumor of intestine'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439191', 'cui_str': 'nmol'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1276061', 'cui_str': 'Acute non-ST segment elevation myocardial infarction'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",120.0,0.763507,"Urine NTx to creatinine ratio (nmol bone collagen equivalent:mmol creatinine) did not differ significantly between treatment groups at 26 weeks: 40·5 (95% CI 34·9-47·0) for placebo, 43·4 (37·4-50·5) for 50 μg, and 42·2 (37·5-47·6) for 200 μg.","[{'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Walsh', 'Affiliation': 'Mellanby Centre for Musculoskeletal Research, University of Sheffield, Northern General Hospital, Sheffield, UK.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Jacques', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Schomburg', 'Affiliation': 'Institut für Experimentelle Endokrinologie, Campus Virchow-Klinikum, Berlin, Germany.'}, {'ForeName': 'Tom R', 'Initials': 'TR', 'LastName': 'Hill', 'Affiliation': 'Human Nutrition Research Centre, Centre for Healthier Lives, Population Health Science Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Mathers', 'Affiliation': 'Human Nutrition Research Centre, Centre for Healthier Lives, Population Health Science Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Graham R', 'Initials': 'GR', 'LastName': 'Williams', 'Affiliation': 'Molecular Endocrinology Laboratory, Department of Metabolism, Digestion and Reproduction, Imperial College London, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Eastell', 'Affiliation': 'Mellanby Centre for Musculoskeletal Research, University of Sheffield, Northern General Hospital, Sheffield, UK.'}]",The Lancet. Healthy longevity,['10.1016/S2666-7568(21)00051-9'] 3334,33842608,Progesterone protocol versus gonadotropin-releasing hormone antagonist protocol in women with polycystic ovarian syndrome undergoing in vitro fertilization treatments with frozen-thawed embryo transfer: a prospective randomized controlled trial.,"Background Exogenous progestational agents have recently been introduced as an alternative pituitary modulator for the prevention of premature luteinizing hormone (LH) surges during in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) treatments. There is increasing evidence that frozen-embryo transfer (FET) is associated with a lower risk of ovarian hyperstimulation syndrome (OHSS) in women with polycystic ovary syndrome (PCOS). Herein, we compared the clinical outcomes of the progesterone protocol with the gonadotropin releasing hormone antagonist (GnRH-ant) protocol in PCOS patients with a ''freeze-all'' strategy. Methods In this prospective single-central randomized controlled trial, a total of 120 PCOS patients undergoing their first IVF/ICSI treatment were randomly assigned to receive the progesterone protocol (study group) or GnRH-ant protocol (control group). The main outcome was the number of oocytes retrieved. Secondary outcomes included the incidence of premature LH rise/surge, the number of viable embryos, and pregnancy outcomes. Results The number of retrieved oocytes (14.65±7.64 versus 12.8±8.57) and viable embryos (5.38±3.54 versus 5.03±3.92) in the study group were comparable to those in the control group (P>0.05). Similarly, no between-group differences were found in the number of mature oocytes, fertilized oocytes, cleaved embryos, and the viable embryo rate per oocyte retrieved (P>0.05). However, the oocyte retrieval rate (66.02%±19.63% versus 54.38%±26.39%) and fertilization rate (78.12%±18.41% versus 62.76%±23.32%) in the study group were significantly more than that in the control group (P<0.05). The mean serum LH value on day 6-7 was lower in the study group than that in the control group (7.47±0.97 versus 3.98±0.52 IU/L, P<0.05), and the incidence of premature LH rise was higher in the study group than in the control group, although no patients experienced premature LH surge. The clinical pregnancy rate [58.82% vs. 57.32%, RR 0.94 (95% CI: 0.508, 1.738), P>0.05] and implantation rate [43.21% vs. 41.4%, RR 0.929 (95% CI: 0.595, 1.448), P>0.05] were also similar between the two groups. Conclusions The progesterone protocol is comparable with the GnRH-ant protocol regarding oocyte/embryo yields and the probability of clinical pregnancy in PCOS patients, but the two regimens were distinct in the regulation of pituitary LH secretion. Trial registration number Chictr.org.cn: ChiCTR-IOR-15006633.",2021,"Conclusions The progesterone protocol is comparable with the GnRH-ant protocol regarding oocyte/embryo yields and the probability of clinical pregnancy in PCOS patients, but the two regimens were distinct in the regulation of pituitary LH secretion. ","[""PCOS patients with a ''freeze-all'' strategy"", 'women with polycystic ovary syndrome (PCOS', '120 PCOS patients undergoing their first IVF/ICSI treatment', 'women with polycystic ovarian syndrome undergoing in vitro fertilization treatments with frozen-thawed embryo transfer']","['gonadotropin releasing hormone antagonist (GnRH-ant) protocol', 'frozen-embryo transfer (FET', 'Progesterone protocol versus gonadotropin-releasing hormone antagonist protocol', 'progesterone protocol (study group) or GnRH-ant protocol (control group']","['viable embryos', 'mean serum LH value', 'incidence of premature LH rise', 'number of oocytes retrieved', 'oocyte retrieval rate', 'incidence of premature LH rise/surge, the number of viable embryos, and pregnancy outcomes', 'number of mature oocytes, fertilized oocytes, cleaved embryos, and the viable embryo rate per oocyte retrieved (P>0.05', 'premature LH surge', 'number of retrieved oocytes', 'clinical pregnancy rate', 'fertilization rate', 'implantation rate']","[{'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}]","[{'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0449803', 'cui_str': 'Number of oocytes'}, {'cui': 'C0404268', 'cui_str': 'Oocyte recovery'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0029974', 'cui_str': 'Ovum'}, {'cui': 'C0205242', 'cui_str': 'Cleaved'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",120.0,0.295199,"Conclusions The progesterone protocol is comparable with the GnRH-ant protocol regarding oocyte/embryo yields and the probability of clinical pregnancy in PCOS patients, but the two regimens were distinct in the regulation of pituitary LH secretion. ","[{'ForeName': 'Xiuxian', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Assisted Reproductive Medicine, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Hongjuan', 'Initials': 'H', 'LastName': 'Ye', 'Affiliation': 'Department of Assisted Reproduction, Shanghai Ninth Peoples Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Department of Assisted Reproduction, Shanghai Ninth Peoples Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yonglun', 'Initials': 'Y', 'LastName': 'Fu', 'Affiliation': 'Department of Assisted Reproductive Medicine, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}]",Annals of translational medicine,['10.21037/atm-20-1592'] 3335,32654603,"Treatment of hard-to-heal leg ulcers with hyaluronic acid, sodium alginate and negative pressure wound therapy.","OBJECTIVE Hard-to-heal lower extremity ulcer is a common healthcare problem and can lead to a poor quality of life (QoL). Despite the advances in wound care, conventional therapies, such as necrotic tissue debridement, cleansing, treatment of infection and local treatment with dressing application are still considered the standard of care in patients with hard-to-heal leg ulcers. However, managing hard-to-heal ulcers that do not respond well to these methods has led to new treatment strategies. In this study, the effects of hyaluronic acid (HA) and sodium alginate (SA), combined with negative pressure wound therapy (NPWT), in patients with hard-to-heal leg ulcers are evaluated. METHOD Patients with hard-to-heal lower extremity ulcers were treated with HA-SA combined with NPWT (HA-SA-NWPT, n=11), or conventional therapy (n=14), between June 2014 and September 2015. Demographics, comorbidities, time to complete healing and change in wound area were recorded and compared. RESULTS A total of 25 patients took part. Complete healing was achieved in 63.6% (n=7) of the patients in the HA-SA with NPWT group, compared with 14.3% (n=2) of the patients in the conventional therapy group (p=0.017). The mean decrease in wound size was significantly higher in the HA-SA-NPWT group than in the conventional therapy group (73.8% versus 34.8%, respectively, p=0.029). Despite a shorter healing period in the HA-SA-NPWT group than in the conventional group, no statistically significant difference was found between groups for time to complete healing (37 days versus 55 days, respectively). CONCLUSION These results demonstrate that the combination of HA-SA-NPWT is a promising treatment for decreasing the healing time and increasing the success rate by their synergistic effect on wound healing in hard-to-heal lower extremity ulcers. However, further studies with a larger number of patients are needed to confirm the results.",2020,"The mean decrease in wound size was significantly higher in the HA-SA-NPWT group than in the conventional therapy group (73.8% versus 34.8%, respectively, p=0.029).","['n=14), between June 2014 and September 2015', 'Patients with hard-to-heal lower extremity ulcers', 'patients with hard-to-heal leg ulcers', '25 patients took part']","['HA-SA combined with NPWT (HA-SA-NWPT, n=11), or conventional therapy', 'hyaluronic acid (HA) and sodium alginate (SA), combined with negative pressure wound therapy (NPWT', 'hyaluronic acid, sodium alginate and negative pressure wound therapy']","['time to complete healing', 'Complete healing', 'shorter healing period', 'healing time', 'mean decrease in wound size', 'Demographics, comorbidities, time to complete healing and change in wound area']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0023223', 'cui_str': 'Ulcer of lower extremity'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0142791', 'cui_str': 'Sodium alginate'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",25.0,0.00522224,"The mean decrease in wound size was significantly higher in the HA-SA-NPWT group than in the conventional therapy group (73.8% versus 34.8%, respectively, p=0.029).","[{'ForeName': 'Omer Arda', 'Initials': 'OA', 'LastName': 'Cetinkaya', 'Affiliation': 'Division of Vascular Surgery, Department of Surgery, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Suleyman Utku', 'Initials': 'SU', 'LastName': 'Celik', 'Affiliation': 'Clinic of General Surgery, Gulhane Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Can Yahya', 'Initials': 'CY', 'LastName': 'Boztug', 'Affiliation': 'Division of Vascular Surgery, Department of Surgery, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Uncu', 'Affiliation': 'Division of Vascular Surgery, Department of Surgery, Ankara University School of Medicine, Ankara, Turkey.'}]",Journal of wound care,['10.12968/jowc.2020.29.7.419'] 3336,32598950,Retinal Specialist versus Artificial Intelligence Detection of Retinal Fluid from OCT: Age-Related Eye Disease Study 2: 10-Year Follow-On Study.,"PURPOSE To evaluate the performance of retinal specialists in detecting retinal fluid presence in spectral domain OCT (SD-OCT) scans from eyes with age-related macular degeneration (AMD) and compare performance with an artificial intelligence algorithm. DESIGN Prospective comparison of retinal fluid grades from human retinal specialists and the Notal OCT Analyzer (NOA) on SD-OCT scans from 2 common devices. PARTICIPANTS A total of 1127 eyes of 651 Age-Related Eye Disease Study 2 10-year Follow-On Study (AREDS2-10Y) participants with SD-OCT scans graded by reading center graders (as the ground truth). METHODS The AREDS2-10Y investigators graded each SD-OCT scan for the presence/absence of intraretinal and subretinal fluid. Separately, the same scans were graded by the NOA. MAIN OUTCOME MEASURES Accuracy (primary), sensitivity, specificity, precision, and F1-score. RESULTS Of the 1127 eyes, retinal fluid was present in 32.8%. For detecting retinal fluid, the investigators had an accuracy of 0.805 (95% confidence interval [CI], 0.780-0.828), a sensitivity of 0.468 (95% CI, 0.416-0.520), a specificity of 0.970 (95% CI, 0.955-0.981). The NOA metrics were 0.851 (95% CI, 0.829-0.871), 0.822 (95% CI, 0.779-0.859), 0.865 (95% CI, 0.839-0.889), respectively. For detecting intraretinal fluid, the investigator metrics were 0.815 (95% CI, 0.792-0.837), 0.403 (95% CI, 0.349-0.459), and 0.978 (95% CI, 0.966-0.987); the NOA metrics were 0.877 (95% CI, 0.857-0.896), 0.763 (95% CI, 0.713-0.808), and 0.922 (95% CI, 0.902-0.940), respectively. For detecting subretinal fluid, the investigator metrics were 0.946 (95% CI, 0.931-0.958), 0.583 (95% CI, 0.471-0.690), and 0.973 (95% CI, 0.962-0.982); the NOA metrics were 0.863 (95% CI, 0.842-0.882), 0.940 (95% CI, 0.867-0.980), and 0.857 (95% CI, 0.835-0.877), respectively. CONCLUSIONS In this large and challenging sample of SD-OCT scans obtained with 2 common devices, retinal specialists had imperfect accuracy and low sensitivity in detecting retinal fluid. This was particularly true for intraretinal fluid and difficult cases (with lower fluid volumes appearing on fewer B-scans). Artificial intelligence-based detection achieved a higher level of accuracy. This software tool could assist physicians in detecting retinal fluid, which is important for diagnostic, re-treatment, and prognostic tasks.",2021,"The NOA metrics were 0.851 (95% CI, 0.829-0.871), 0.822 (95% CI, 0.779-0.859), 0.865 (95% CI, 0.839-0.889), respectively.","['retinal fluid grades from human retinal specialists and the Notal OCT Analyzer (NOA) on SD-OCT scans from 2 common devices', 'eyes with age-related macular degeneration (AMD', 'A total of 1127 eyes of 651 Age-Related Eye Disease Study 2 10-year Follow-On Study (AREDS2-10Y) participants with SD-OCT scans graded by reading center graders (as the ground truth']",['Retinal Specialist versus Artificial Intelligence Detection of Retinal Fluid from OCT'],"['NOA metrics', 'Accuracy (primary), sensitivity, specificity, precision, and F1-score', 'retinal fluid']","[{'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0179038', 'cui_str': 'Analyzer'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0015397', 'cui_str': 'Disorder of eye'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}]","[{'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0179038', 'cui_str': 'Analyzer'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}]",1127.0,0.613822,"The NOA metrics were 0.851 (95% CI, 0.829-0.871), 0.822 (95% CI, 0.779-0.859), 0.865 (95% CI, 0.839-0.889), respectively.","[{'ForeName': 'Tiarnan D L', 'Initials': 'TDL', 'LastName': 'Keenan', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland. Electronic address: tiarnan.keenan@nih.gov.'}, {'ForeName': 'Traci E', 'Initials': 'TE', 'LastName': 'Clemons', 'Affiliation': 'The EMMES Company, LLC, Rockville, Maryland.'}, {'ForeName': 'Amitha', 'Initials': 'A', 'LastName': 'Domalpally', 'Affiliation': 'Fundus Photograph Reading Center, University of Wisconsin, Madison, Wisconsin.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Elman', 'Affiliation': 'Elman Retina Group, Baltimore, Maryland.'}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Havilio', 'Affiliation': 'Notal Vision Ltd., Tel Aviv, Israel.'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Agrón', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Gidi', 'Initials': 'G', 'LastName': 'Benyamini', 'Affiliation': 'Notal Vision Ltd., Tel Aviv, Israel.'}, {'ForeName': 'Emily Y', 'Initials': 'EY', 'LastName': 'Chew', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}]",Ophthalmology,['10.1016/j.ophtha.2020.06.038'] 3337,32525465,"Viral load outcomes in a cohort of alcohol-consuming people living with HIV receiving antiretroviral therapy in Mumbai, India.","We examined the association between alcohol consumption, adherence and viral load (VL) in a cohort of 940 alcohol-consuming, human immunodeficiency virus (HIV)-positive men receiving antiretroviral therapy in Mumbai. Some of the participants (16.7%) had missed >1 doses in the last four days and 17.6% reported >1 treatment interruptions in the last 12 months; 60.8% of the participants consumed alcohol >2 times/month, 62.8% consumed >3 drinks/typical day and 11.5% reported binge drinking >1 times/month; 76.4% of the participants had VL<200 copies/mL. Higher alcohol consumption was associated with nonadherence (odds ratio [OR]: 1.21; 95% confidence interval [CI]: 1.11-1.31) and treatment interruptions (OR: 1.20; 95% CI: 1.11-1.31). We found no association between alcohol use and VL. There was, however, a significant interaction effect of alcohol use and nonadherence on virological failure (Adjusted Odds Ratio [AOR]: 1.23; 95% CI: 1.03-1.47) implying that alcohol negatively impacts VL outcomes but mediated through adherence. Alcohol use was associated with poor adherence, which in turn was a strong predictor of virological failure.",2020,We found no association between alcohol use and VL.,"['a cohort of alcohol-consuming people living with HIV receiving antiretroviral therapy in Mumbai, India', 'a cohort of 940 alcohol-consuming, human immunodeficiency virus (HIV)-positive men receiving antiretroviral therapy in Mumbai']",[],"['binge drinking', 'alcohol consumption, adherence and viral load (VL', 'alcohol use and nonadherence on virological failure']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C4517905', 'cui_str': '940'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0025266', 'cui_str': 'Man'}]",[],"[{'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",940.0,0.161043,We found no association between alcohol use and VL.,"[{'ForeName': 'Avina', 'Initials': 'A', 'LastName': 'Sarna', 'Affiliation': 'Population Council, New Delhi, India.'}, {'ForeName': 'Roopal J', 'Initials': 'RJ', 'LastName': 'Singh', 'Affiliation': 'Population Council, New Delhi, India.'}, {'ForeName': 'Jean J', 'Initials': 'JJ', 'LastName': 'Schensul', 'Affiliation': 'Institute for Community Research, Hartford, CT, USA.'}, {'ForeName': 'Sushma S', 'Initials': 'SS', 'LastName': 'Gaikwad', 'Affiliation': 'Medical College & B.Y.L. Nair Ch. Hospital, Mumbai, India.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Joshi', 'Affiliation': 'Department of Medicine, Seth G S Medical College, Mumbai, India.'}, {'ForeName': 'Rupal', 'Initials': 'R', 'LastName': 'Malye', 'Affiliation': 'Department of Medicine, Lokmanya Tilak Municipal Medical College, Mumbai, India.'}, {'ForeName': 'Bidhubhushan', 'Initials': 'B', 'LastName': 'Mahapatra', 'Affiliation': 'Population Council, New Delhi, India.'}, {'ForeName': 'Toan', 'Initials': 'T', 'LastName': 'Ha', 'Affiliation': 'School of Medicine, University of Connecticut, Farmington, CT, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Schensul', 'Affiliation': 'School of Medicine, University of Connecticut, Farmington, CT, USA.'}]",International journal of STD & AIDS,['10.1177/0956462420921731'] 3338,32514012,"Increased AT 2 R expression is induced by AT 1 R autoantibody via two axes, Klf-5/IRF-1 and circErbB4/miR-29a-5p, to promote VSMC migration.","Vascular remodeling can be caused by angiotensin II type 1 receptor (AT 1 R) autoantibody (AT1-AA), although the related mechanism remains unknown. Angiotensin II type 2 receptor (AT 2 R) plays multiple roles in vascular remodeling through cross-talk with AT 1 R in the cytoplasm. Here, we aimed to explore the role and mechanism of AT 2 R in AT1-AA-induced vascular smooth muscle cell (VSMC) migration, which is a key event in vascular remodeling. In vitro and in vivo, we found that AT 2 R can promote VSMC migration in AT1-AA-induced vascular remodeling. Moreover, AT 2 R expression was upregulated via Klf-5/IRF-1-mediated transcriptional and circErbB4/miR-29a-5p-mediated posttranscriptional mechanisms in response to AT1-AA. Our data provide a molecular basis for AT1-AA-induced AT 2 R expression by transcription factors, namely, a circular RNA and a microRNA, and showed that AT 2 R participated in AT1-AA-induced VSMC migration during the development of vascular remodeling. AT 2 R may be a potential target for the treatment of AT1-AA-induced vascular diseases.",2020,Angiotensin II type 2 receptor (AT 2 R) plays multiple roles in vascular remodeling through cross-talk with AT 1 R in the cytoplasm.,[],['Angiotensin II type 2 receptor (AT 2 R'],[],[],"[{'cui': 'C0390423', 'cui_str': 'Angiotensin II Type 2 Receptor'}]",[],,0.0214678,Angiotensin II type 2 receptor (AT 2 R) plays multiple roles in vascular remodeling through cross-talk with AT 1 R in the cytoplasm.,"[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Physiology & Pathophysiology, School of Basic Medical Sciences, Capital Medical University, 100069, Beijing, PR China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Physiology & Pathophysiology, School of Basic Medical Sciences, Capital Medical University, 100069, Beijing, PR China.'}, {'ForeName': 'Meili', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Physiology & Pathophysiology, School of Basic Medical Sciences, Capital Medical University, 100069, Beijing, PR China.'}, {'ForeName': 'Mingming', 'Initials': 'M', 'LastName': 'Yue', 'Affiliation': 'Department of Physiology & Pathophysiology, School of Basic Medical Sciences, Capital Medical University, 100069, Beijing, PR China.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Bai', 'Affiliation': 'Department of Physiology & Pathophysiology, School of Basic Medical Sciences, Capital Medical University, 100069, Beijing, PR China.'}, {'ForeName': 'Jingwei', 'Initials': 'J', 'LastName': 'Bian', 'Affiliation': 'Department of Physiology & Pathophysiology, School of Basic Medical Sciences, Capital Medical University, 100069, Beijing, PR China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Hao', 'Affiliation': 'Department of Physiology & Pathophysiology, School of Basic Medical Sciences, Capital Medical University, 100069, Beijing, PR China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Physiology, Basic Medical College, Changzhi Medical College, 046000, Changzhi, Shanxi, PR China.'}, {'ForeName': 'Suli', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Physiology & Pathophysiology, School of Basic Medical Sciences, Capital Medical University, 100069, Beijing, PR China. sueney716@126.com.'}, {'ForeName': 'Huirong', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Physiology & Pathophysiology, School of Basic Medical Sciences, Capital Medical University, 100069, Beijing, PR China. liuhr2000@ccmu.edu.cn.'}]",Cell death & disease,['10.1038/s41419-020-2643-5'] 3339,32511207,Saline-Air Hysterosalpingo-Contrast Sonography Is Equivalent to the Modified Hysterosalpingogram Following Hysteroscopic Sterilization.,"PURPOSE To estimate the diagnostic efficacy of saline-air hysterosalpingo-contrast sonography (SA-HyCoSy) compared with the modified hysterosalpingogram (mHSG) for confirmation of both coil location and tubal occlusion following hysteroscopic sterilization. METHODS This study included 19 women who underwent both SA-HyCoSy and mHSG where 1 test was followed by the other. Sensitivity, specificity, and positive and negative predictive values for tubal occlusion against the mHSG were calculated for each fallopian tube by 2 independent interpreters. Interrater reliability was assessed using Cohen κ statistic. Procedure time and pain level by 11-point numeric rating scale of SA-HyCoSy and mHSG were also compared. RESULTS Thirty-eight fallopian tubes were evaluated. Tubal occlusion was noted in 97.3% of tubes for both interpreters with the mHSG compared with 92.1% and 94.7% with SA-HyCoSy. The positive and negative predictive values for tubal occlusion were 100%/100% and 50%/33%, respectively, with an overall agreement of 97.4% and 95.7%, κ = 0.48, P < 0.01. Saline-air HyCoSy changed interpretation of coil insert location in 50% and 44.7% for each interpreter, being downgraded from optimal to satisfactory in 42.9% (9/21) and 36% (9/25) and upgraded to optimal in 58.8% (10/17) and 61.5% (8/13), respectively. There were no statistically significant differences in procedural time (7.5 vs 9.4 minutes, P > 0.05) or maximum pain scores (2.3 vs 3.1, P > 0.05) for the mHSG compared with SA-HyCoSy. CONCLUSIONS Our findings revealed a high degree of diagnostic accuracy with SA-HyCoSy for tubal occlusion, although coil location changed in nearly half of cases. Avoidance of radiation and patient convenience/compliance with SA-HyCoSy may outweigh the drawbacks.",2020,"There were no statistically significant differences in procedural time (7.5 vs 9.4 minutes, P > 0.05) or maximum pain scores (2.3 vs 3.1, P > 0.05) for the mHSG compared with SA-HyCoSy. CONCLUSIONS ","['19 women who underwent both SA-HyCoSy and mHSG where 1 test was followed by the other', 'Thirty-eight fallopian tubes']","['SA-HyCoSy', 'Hysteroscopic Sterilization', 'Saline-air HyCoSy', 'saline-air hysterosalpingo-contrast sonography (SA-HyCoSy', 'modified hysterosalpingogram (mHSG', 'Saline-Air Hysterosalpingo-Contrast Sonography', 'Modified Hysterosalpingogram']","['maximum pain scores', 'positive and negative predictive values for tubal occlusion', 'Procedure time and pain level by 11-point numeric rating scale of SA-HyCoSy and mHSG', 'coil insert location', 'Interrater reliability', 'diagnostic efficacy', 'Sensitivity, specificity, and positive and negative predictive values for tubal occlusion against the mHSG', 'procedural time', 'Tubal occlusion']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0412553', 'cui_str': 'HYCOSY - Hysterosalpingo contrast sonography'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0015560', 'cui_str': 'Fallopian tube structure'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0412553', 'cui_str': 'HYCOSY - Hysterosalpingo contrast sonography'}, {'cui': 'C0038280', 'cui_str': 'Sterilization'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0038289', 'cui_str': 'Sterilization, Tubal'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0412553', 'cui_str': 'HYCOSY - Hysterosalpingo contrast sonography'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}]",19.0,0.074056,"There were no statistically significant differences in procedural time (7.5 vs 9.4 minutes, P > 0.05) or maximum pain scores (2.3 vs 3.1, P > 0.05) for the mHSG compared with SA-HyCoSy. CONCLUSIONS ","[{'ForeName': 'Emerly', 'Initials': 'E', 'LastName': 'Luong', 'Affiliation': 'Department of Obstetrics and Gynecology, Wright State University, Boonshoft School of Medicine, Dayton, OH.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Ludwin', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Winter', 'Affiliation': 'Department of Radiology and Imaging Sciences, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Yaklic', 'Affiliation': 'Department of Obstetrics and Gynecology, Wright State University, Boonshoft School of Medicine, Dayton, OH.'}, {'ForeName': 'Rose A', 'Initials': 'RA', 'LastName': 'Maxwell', 'Affiliation': 'Department of Obstetrics and Gynecology, Wright State University, Boonshoft School of Medicine, Dayton, OH.'}, {'ForeName': 'Bala', 'Initials': 'B', 'LastName': 'Bhagavath', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Wisconsin Madison, WI.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Lindheim', 'Affiliation': ''}]",Ultrasound quarterly,['10.1097/RUQ.0000000000000488'] 3340,32107818,The role and outcomes of new supraventricular tachycardia among patients with mild heart failure.,"INTRODUCTION We aimed to assess the predictors of new supraventricular tachycardia (SVT) and the association of new SVT with subsequent clinical outcomes among mild heart failure (HF) patients. METHODS AND RESULTS The study population comprised patients enrolled in MADIT-CRT, after exclusion of patients with atrial arrhythmias before enrollment (N = 325). Multivariate analysis was used to identify predictors of new-onset SVT and the association of time-dependent development of SVT with subsequent ventricular tachyarrhythmic events (VTEs), HF-hospitalizations, and death. SVT burden was categorized into three groups based on the number of episodes per patient; (a) Low <10, (b) Intermediate ≥10 but <20, and (c) High ≥20. During mean follow up of 3.4 ± 1.1 years, 41(3%) subjects developed new SVT. African American race, diastolic blood pressure (DBP) >80 mmHg and prior non sustained ventricular arrhythmia were independent predictors for SVT. Multivariate analysis showed that the development of time-dependent SVT was associated with a >4-fold increased risk for VTEs (HR = 4.3; 95% CI: 1.6-11.7; P = .004) and with a >6-fold increased risk for all-cause mortality (HR = 6.5; 95% CI: 2.3-18.7; P < .001), but not with HF hospitalizations (HR = 2.2; 95% CI: 0.7-7.2; P = .17). Intermediate, and high SVT-burden were each independent risk factors for death when compared with Low burden (HR = 9.1; P = .03, and HR = 19.4; P < .001; respectively). CONCLUSIONS In patients with mild HF, the development of new-onset SVT after device implantation is related to distinct baseline clinical and epidemiologic characteristics and is associated with a significant increase in subsequent adverse outcomes, including VTEs and death.",2020,"During mean follow up of 3.4 ± 1.1 years, 41(3%) subjects developed new SVT.","['mild heart failure (HF) patients', 'patients enrolled in MADIT-CRT, after exclusion of patients with atrial arrhythmias before enrollment (N\u2009=\u2009325', 'patients with mild heart failure']",[],"['new SVT', 'risk for VTEs', 'SVT with subsequent ventricular tachyarrhythmic events (VTEs), HF-hospitalizations, and death', 'diastolic blood pressure (DBP']","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}, {'cui': 'C0085611', 'cui_str': 'Atrial arrhythmia'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C4517714', 'cui_str': '325'}]",[],"[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0039240', 'cui_str': 'Supraventricular tachycardia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",,0.190687,"During mean follow up of 3.4 ± 1.1 years, 41(3%) subjects developed new SVT.","[{'ForeName': 'Arwa', 'Initials': 'A', 'LastName': 'Younis', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Goldenberg', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'McNitt', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Zareba', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Kutyifa', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Mehmet K', 'Initials': 'MK', 'LastName': 'Aktas', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.14416'] 3341,32083365,Impact of wearable cardioverter-defibrillator compliance on outcomes in the VEST trial: As-treated and per-protocol analyses.,"BACKGROUND Vest Prevention of Early Sudden Death Trial did not demonstrate a significant reduction in arrhythmic death with the wearable cardioverter-defibrillator (WCD), but compliance with the device may have substantially affected the results. ThePletcher influence of WCD compliance on outcomes has not yet been fully evaluated. METHODS Using linear and pooled logistic models, we performed as-treated analyses omitting person-time in the hospital and adjusted for correlates of WCD compliance. To assess the impact of early stopping of WCD, we performed a per-protocol Kaplan-Meier analysis, censoring after the last day the WCD was worn. Interactions of potential effect modifiers with treatment assignment and WCD compliance on outcomes were investigated. Finally, we used linear models to identify predictors of WCD compliance. RESULTS A per-protocol analysis demonstrated a significant reduction in total (P < .001) and arrhythmic (P = .001) mortality. Better WCD compliance was independently predicted by cardiac arrest during index myocardial infarction (MI), higher Cr, diabetes, prior heart failure, EF ≤ 25%, Polish enrolling center and number of WCD alarms, while worse compliance was predicted by being divorced, Asian race, higher body mass index, prior percutaneous coronary intervention, or any WCD shock. Neither excluding time in hospital from the as-treated analysis nor adjustment for factors affecting WCD compliance materially changed the results. No variable demonstrated a significant interaction in either the intention-to-treat or as-treated analysis. CONCLUSION Robust sensitivity analyses of as-treated and per-protocol analyses suggest that the WCD is protective in compliant patients with ejection fraction less than or equal to 35% during the first 3 months post-MI.",2020,"RESULTS A per-protocol analysis demonstrated a significant reduction in total (P < .001) and arrhythmic (P = .001) mortality.",[],"['WCD', 'wearable cardioverter-defibrillator compliance']","['cardiac arrest during index myocardial infarction (MI), higher Cr, diabetes, prior heart failure, EF\u2009≤\u200925%, Polish enrolling center and number of WCD alarms', 'arrhythmic death', 'arrhythmic']",[],"[{'cui': 'C0180307', 'cui_str': 'Defibrillator'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]","[{'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0180307', 'cui_str': 'Defibrillator'}, {'cui': 'C0336648', 'cui_str': 'Alarm'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.0926792,"RESULTS A per-protocol analysis demonstrated a significant reduction in total (P < .001) and arrhythmic (P = .001) mortality.","[{'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Olgin', 'Affiliation': 'Division of Cardiology and the Cardiovascular Research Institute, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Byron K', 'Initials': 'BK', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology and the Cardiovascular Research Institute, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vittinghoff', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Morin', 'Affiliation': 'Ochsner Medical Center and Ochsner Clinical School, School of Medicine, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Zweibel', 'Affiliation': 'Hartford Healthcare, Vascular Institute and University of Connecticut School of Medicine, Hartford, Connecticut.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Rashba', 'Affiliation': 'Stony Brook Medicine, Stony Brook, New York.'}, {'ForeName': 'Eugene H', 'Initials': 'EH', 'LastName': 'Chung', 'Affiliation': 'Department of Internal Medicine, Michigan Medicine University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Borggrefe', 'Affiliation': 'First Department of Medicine-Cardiology, University Medical Center Mannheim, Mannheim, Germany.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Hulley', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Lin', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Trisha F', 'Initials': 'TF', 'LastName': 'Hue', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Pletcher', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.14404'] 3342,31621062,Basic symptoms influence real-life functioning and symptoms in individuals at high risk for psychosis.,"OBJECTIVE To investigate potential clinical differences in high-risk profiles presenting with and without basic symptoms, and additionally investigate the association between basic symptoms and clinical symptoms, functioning, and cognition. METHODS High-risk individuals (n = 133) were stratified into individuals fulfilling ultra-high-risk (UHR) criteria (n = 59) and individuals fulfilling UHR+ basic symptoms criteria (BS) (n = 74). Group differences were assessed on clinical symptoms, real-life functioning, and cognition. Regression analyses were conducted to elucidate on the relationship between BS and clinical symptoms, functioning, neurocognition, and social cognition. RESULTS The group fulfilling both UHR+ BS criteria had significantly more symptoms and lower real-life functioning and quality of life but not more cognitive deficits. BS influenced on attenuated psychotic, depressive, and general symptoms, but only modestly on negative symptoms. No relationship between BS and neuro- and social cognition was established except for an association with emotion recognition processing speed. BS influenced real-life functioning, and this finding was sustained when controlling for the effect of negative symptoms. CONCLUSIONS Our findings indicate that BS contribute highly to the distress and symptom load of clinical high-risk individuals. Longitudinal findings are needed to establish the predictive validity of BS on high-risk individuals' clinical and functional prognosis.",2020,The group fulfilling both UHR+ BS criteria had significantly more symptoms and lower real-life functioning and quality of life but not more cognitive deficits.,"['High-risk individuals (n\xa0=\xa0133) were stratified into individuals fulfilling ultra-high-risk (UHR) criteria (n\xa0=\xa059) and individuals fulfilling UHR+ basic symptoms criteria (BS) (n\xa0=\xa074', 'individuals at high risk for psychosis']",[],"['psychotic, depressive, and general symptoms', 'negative symptoms', 'real-life functioning', 'symptoms and lower real-life functioning and quality of life', 'BS and clinical symptoms, functioning, neurocognition, and social cognition', 'clinical symptoms, real-life functioning, and cognition', 'BS and neuro- and social cognition']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]",[],"[{'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0159028', 'cui_str': 'General symptom'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}]",133.0,0.164436,The group fulfilling both UHR+ BS criteria had significantly more symptoms and lower real-life functioning and quality of life but not more cognitive deficits.,"[{'ForeName': 'L B', 'Initials': 'LB', 'LastName': 'Glenthøj', 'Affiliation': 'Copenhagen Research Centre for Mental Health (CORE), Copenhagen University Hospital, Hellerup, Denmark.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bailey', 'Affiliation': 'University of Basel Psychiatric Clinics, Basel, Switzerland.'}, {'ForeName': 'T D', 'Initials': 'TD', 'LastName': 'Kristensen', 'Affiliation': 'Copenhagen Research Centre for Mental Health (CORE), Copenhagen University Hospital, Hellerup, Denmark.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Wenneberg', 'Affiliation': 'Copenhagen Research Centre for Mental Health (CORE), Copenhagen University Hospital, Hellerup, Denmark.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hjorthøj', 'Affiliation': 'Copenhagen Research Centre for Mental Health (CORE), Copenhagen University Hospital, Hellerup, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nordentoft', 'Affiliation': 'Copenhagen Research Centre for Mental Health (CORE), Copenhagen University Hospital, Hellerup, Denmark.'}]",Acta psychiatrica Scandinavica,['10.1111/acps.13117'] 3343,31343789,Pretreatment Posttraumatic Stress Disorder Symptom Network Metrics Predict the Strength of the Association Between Node Change and Network Change During Treatment.,"Network analysis has been increasingly applied in an effort to understand complex interactions among symptoms in posttraumatic stress disorder (PTSD). Although methods that initially focused on identifying central symptoms in cross-sectional networks have been extended to longitudinal data that can reveal the relative roles of acute symptoms in the emergence of the PTSD syndrome, the association between network metrics and symptom change during treatment have yet to be explored in PTSD. To address this gap, we estimated pretreatment PTSD symptom networks in a sample of patients from a multisite clinical trial for women with full or subthreshold PTSD and substance use. We tested the hypothesis that node metrics calculated in the pretreatment network would be predictive of the strength of the association between a symptom's change and the change in the severity of all other symptoms through the course of treatment. A symptom node's strength and predictability in the pretreatment network were each strongly correlated with the association between that symptom's change and overall change across the symptom network, r(15) = .79, p < .001 and r(15) = .75, p < .001, respectively, whereas a symptom's mean severity at pretreatment was not, r(15) = .27, p = .292. These findings suggest that a node's centrality prior to treatment engagement is a predictor of its association with overall symptom change throughout the treatment process.",2020,".75, p < .001, respectively, whereas a symptom's mean severity at pretreatment was not, r(15) =",['sample of patients from a multisite clinical trial for women with full or subthreshold PTSD and substance use'],[],[],"[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}]",[],[],,0.119282,".75, p < .001, respectively, whereas a symptom's mean severity at pretreatment was not, r(15) =","[{'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Papini', 'Affiliation': 'Institute for Mental Health Research and Department of Psychology, University of Texas at Austin, Austin, Texas, USA.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Rubin', 'Affiliation': 'Institute for Mental Health Research and Department of Psychology, University of Texas at Austin, Austin, Texas, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Telch', 'Affiliation': 'Institute for Mental Health Research and Department of Psychology, University of Texas at Austin, Austin, Texas, USA.'}, {'ForeName': 'Jasper A J', 'Initials': 'JAJ', 'LastName': 'Smits', 'Affiliation': 'Institute for Mental Health Research and Department of Psychology, University of Texas at Austin, Austin, Texas, USA.'}, {'ForeName': 'Denise A', 'Initials': 'DA', 'LastName': 'Hien', 'Affiliation': 'Center of Alcohol Studies, Rutgers, The State University of New Jersey, New Brunswick, New Jersey, USA.'}]",Journal of traumatic stress,['10.1002/jts.22379'] 3344,33842250,Laparoscopic versus open radical antegrade modular pancreatosplenectomy for pancreatic cancer: a single-institution comparative study.,"Background Laparoscopic distal pancreatosplenectomy is an effective and safe surgical modality for treating benign and borderline distal pancreatic tumors, but rarely for pancreatic cancer. This study aimed to compare the feasibility and safety of laparoscopic and open radical antegrade modular pancreatosplenectomy for pancreatic cancer. Methods Fifty-one patients with pancreatic cancer who underwent radical antegrade modular pancreatosplenectomy at Ningbo Medical Center Lihuili Hospital between January 2014 and July 2018 were enrolled. 20 patients underwent laparoscopic radical antegrade modular pancreatosplenectomy and 31 patients received open radical antegrade modular pancreatosplenectomy. Postoperative and short-term outcomes of the two groups of patients were analyzed. Results The mean operation time, length of postoperative hospital stay, and overall postoperative morbidity were similar in the two groups (P>0.05). The laparoscopic radical antegrade modular pancreatosplenectomy group lost less blood (252.5±198.3 vs. 472.6±428.0 mL, P=0.037) and had lower transfusion rates (10.0% vs. 35.4%, P=0.041) than the open radical antegrade modular pancreatosplenectomy group. The laparoscopic group also had statistically significantly earlier passing of first flatus (2.5±0.8 vs. 3.2±1.2 days, P=0.028) and first oral intake (2.9±1.0 vs. 3.7±1.6 days, P=0.042). Furthermore, the rates of postoperative pancreatic fistula (45.0% vs. 32.3%) and overall complications (70.0% vs. 74.2%) were not statistically difference between the two groups. The survival rates at 6 months, 1 year, and 2 years after surgery were not statistically difference between the laparoscopic and open groups (94.4% vs. 93.5, 67.0% vs. 78.0%, and 50.2% vs. 38.3%, respectively). Conclusions The results of this study show that laparoscopic radical antegrade modular pancreatosplenectomy is feasible and safe for the treatment of pancreatic cancer.",2021,"The survival rates at 6 months, 1 year, and 2 years after surgery were not statistically difference between the laparoscopic and open groups (94.4% vs. 93.5, 67.0% vs. 78.0%, and 50.2% vs. 38.3%, respectively). ","['20 patients underwent', 'pancreatic cancer', 'Methods\n\n\nFifty-one patients with pancreatic cancer who underwent radical antegrade modular pancreatosplenectomy at Ningbo Medical Center Lihuili Hospital between January 2014 and July 2018 were enrolled']","['laparoscopic radical antegrade modular pancreatosplenectomy', 'open radical antegrade modular pancreatosplenectomy', 'Laparoscopic versus open radical antegrade modular pancreatosplenectomy', 'laparoscopic and open radical antegrade modular pancreatosplenectomy']","['rates of postoperative pancreatic fistula', 'transfusion rates', 'overall complications', 'feasibility and safety', 'earlier passing of first flatus', 'survival rates', 'mean operation time, length of postoperative hospital stay, and overall postoperative morbidity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0589502', 'cui_str': 'Antegrade direction'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0589502', 'cui_str': 'Antegrade direction'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic fistula'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",51.0,0.08627,"The survival rates at 6 months, 1 year, and 2 years after surgery were not statistically difference between the laparoscopic and open groups (94.4% vs. 93.5, 67.0% vs. 78.0%, and 50.2% vs. 38.3%, respectively). ","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of General Surgery, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Chaojie', 'Initials': 'C', 'LastName': 'Xiong', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Surgery, Ningbo Medical Center Lihuili Hospital, Ningbo University, Ningbo, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Sheng', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Surgery, Ningbo Medical Center Lihuili Hospital, Ningbo University, Ningbo, China.'}, {'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Surgery, Ningbo Medical Center Lihuili Hospital, Ningbo University, Ningbo, China.'}, {'ForeName': 'Cai-De', 'Initials': 'CD', 'LastName': 'Lu', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Surgery, Ningbo Medical Center Lihuili Hospital, Ningbo University, Ningbo, China.'}, {'ForeName': 'Xiujun', 'Initials': 'X', 'LastName': 'Cai', 'Affiliation': 'Department of General Surgery, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}]",Gland surgery,['10.21037/gs-21-56'] 3345,33136237,Focused Update on AAV-Based Gene Therapy Clinical Trials for Inherited Retinal Degeneration.,"Inherited retinal diseases (IRDs) comprise a clinically and genetically heterogeneous group of disorders that can ultimately result in photoreceptor dysfunction/death and vision loss. With over 270 genes known to be involved in IRDs, translation of treatment strategies into clinical applications has been historically difficult. However, in recent years there have been significant advances in basic research findings as well as translational studies, culminating in an increasing number of clinical trials with the ultimate goal of reducing vision loss and associated morbidities. The recent approval of Luxturna ® (voretigene neparvovec-rzyl) for Leber congenital amaurosis type 2 (LCA2) prompts a review of the current clinical trials for IRDs, with a particular focus on the importance of adeno-associated virus (AAV)-based gene therapies. The present article reviews the current state of AAV use in gene therapy clinical trials for IRDs, with a brief background on AAV and the reasons behind its dominance in ocular gene therapy. It will also discuss pre-clinical progress in AAV-based therapies aimed at treating other ocular conditions that can have hereditable links, and what alternative technologies are progressing in the same therapeutic space.",2020,"The recent approval of Luxturna ® (voretigene neparvovec-rzyl) for Leber congenital amaurosis type 2 (LCA2) prompts a review of the current clinical trials for IRDs, with a particular focus on the importance of adeno-associated virus (AAV)-based gene therapies.",[],[],[],[],[],[],,0.134235,"The recent approval of Luxturna ® (voretigene neparvovec-rzyl) for Leber congenital amaurosis type 2 (LCA2) prompts a review of the current clinical trials for IRDs, with a particular focus on the importance of adeno-associated virus (AAV)-based gene therapies.","[{'ForeName': 'Paula I', 'Initials': 'PI', 'LastName': 'Fuller-Carter', 'Affiliation': 'Centre for Ophthalmology and Visual Sciences (Incorporating Lions Eye Institute), The University of Western Australia, Nedlands, WA, Australia.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Basiri', 'Affiliation': 'Centre for Ophthalmology and Visual Sciences (Incorporating Lions Eye Institute), The University of Western Australia, Nedlands, WA, Australia.'}, {'ForeName': 'Alan R', 'Initials': 'AR', 'LastName': 'Harvey', 'Affiliation': 'School of Human Sciences, The University of Western Australia, Crawley, WA, Australia.'}, {'ForeName': 'Livia S', 'Initials': 'LS', 'LastName': 'Carvalho', 'Affiliation': 'Centre for Ophthalmology and Visual Sciences (Incorporating Lions Eye Institute), The University of Western Australia, Nedlands, WA, Australia. liviacarvalho@lei.org.au.'}]","BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy",['10.1007/s40259-020-00453-8'] 3346,33105016,Clinical Trials of IL-12/IL-23 Inhibitors in Inflammatory Bowel Disease.,"The inflammatory bowel diseases (IBDs) are chronic immune-mediated inflammatory disorders, including ulcerative colitis (UC) and Crohn's disease (CD). IBD results from a complex interplay between environmental, microbial, and genetic factors to create an abnormal immunological response leading to intestinal inflammation. Many pathways driving inflammation have been described, and different pathways may predominate in an individual patient. The interleukin (IL)-23 pathway plays a key role in IBD pathogenesis through promoting a pathological Th17 response. Targeting IL-23 is effective in the treatment of IBD. Ustekinumab, a monoclonal antibody targeting the shared p40 subunit of IL-12/23, is approved for treatment of moderate-to-severe CD and UC. Specific IL-23p19 antagonists are in development and promising results from phase II trials of mirikizumab and risankizumab underscore the potential for this class of treatment. In this review, we summarize the mechanisms of action and the evidence from clinical trials supporting the efficacy and safety of different IL-23 antagonists for IBD.",2020,"Ustekinumab, a monoclonal antibody targeting the shared p40 subunit of IL-12/23, is approved for treatment of moderate-to-severe CD and UC.",[],['IL-12/IL-23 Inhibitors'],[],[],"[{'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]",[],,0.0866214,"Ustekinumab, a monoclonal antibody targeting the shared p40 subunit of IL-12/23, is approved for treatment of moderate-to-severe CD and UC.","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Almradi', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Western University, London, ON, Canada.'}, {'ForeName': 'Jurij', 'Initials': 'J', 'LastName': 'Hanzel', 'Affiliation': 'Alimentiv, Inc., London, ON, Canada.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Sedano', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Western University, London, ON, Canada.'}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Parker', 'Affiliation': 'Alimentiv, Inc., London, ON, Canada.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Feagan', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Western University, London, ON, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Alimentiv, Inc., London, ON, Canada.'}, {'ForeName': 'Vipul', 'Initials': 'V', 'LastName': 'Jairath', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Western University, London, ON, Canada. vjairath@uwo.ca.'}]","BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy",['10.1007/s40259-020-00451-w'] 3347,33847597,Mobile Phone Intervention Based on an HIV Risk Prediction Tool for HIV Prevention Among Men Who Have Sex With Men in China: Randomized Controlled Trial.,"BACKGROUND eHealth interventions based on risk stratification have not been extensively applied for HIV behavioral interventions among HIV-negative men who have sex with men (MSM). OBJECTIVE This study aimed to evaluate the efficacy of a mobile phone intervention based on an HIV risk prediction tool in promoting HIV testing and reducing high-risk behavior among HIV-negative MSM in China. METHODS We performed a mobile phone-based randomized controlled clinical trial for 12 weeks. A comprehensive intervention package deployed on Jinshuju-an online survey platform-was developed and consisted of 4 components: (1) a validated HIV risk prediction tool that provides information on personalized risk reduction interventions; (2) a map of individualized HIV testing facilities based on their geographic location; (3) a QR code for free resources on HIV prevention, including condoms and HIV self-testing kits; and (4) general resources for HIV health education. MSM participants recruited from WeChat/QQ groups were randomly assigned to the intervention or control group at a 1:1 ratio. The staff sent the QR code for the comprehensive intervention package to MSM in the intervention group over WeChat and sent the QR code only for the resources on HIV health education to those in the control group. At baseline and 12-week follow-up, data on HIV-related risk behavior and HIV testing behavior were collected through the Jinshuju online survey platform. RESULTS In total, 192 MSM were recruited and assigned to the intervention or control group (n=96 each). At week 12, the total clinical trial retention rate was 87.5%. The number of male sexual partners of the MSM in the past 3 months was significantly lower in the intervention group than in the control group (3.51, SD 4.1 vs 6.01, SD 11.4, respectively; mean difference -2.5; 95% CI -5.12 to 0.12; P=.05); the rate of condom use with casual sexual partners was higher in the intervention group than in the control group (87%, n=66/76 vs 70%, n=54/77 respectively; odds ratio 2.81, 95% CI 1.23-6.39; P=.01). The proportion of individuals intending to undergo HIV testing after in the following 30 days was marginally higher in the intervention group than in the control group (90%, n=77/86 vs 79%, n=65/82 respectively; odds ratio 2.20, 95% CI 0.90-5.35; P=.07). The incremental cost-effectiveness ratio of eHealth intervention was US $131.60 on reducing 1 sexual partner and US $19.70 for a 1% increment in condom usage with casual partners. CONCLUSIONS A comprehensive intervention based on an HIV risk prediction tool can reduce the number of male sexual partners among MSM and increase the rate of condom use with casual partners. Hence, this intervention is a very promising preventive strategy for HIV among MSM, especially in areas with a prominent HIV epidemic. TRIAL REGISTRATION Chinese Clinical Trial Registry ChiCTR1800017268; http://www.chictr.org.cn/showprojen.aspx?proj=29271.",2021,"The proportion of individuals intending to undergo HIV testing after in the following 30 days was marginally higher in the intervention group than in the control group (90%, n=77/86 vs 79%, n=65/82 respectively; odds ratio 2.20, 95% CI 0.90-5.35; P=.07).","['Who Have Sex With Men in China', 'HIV-negative men who have sex with men (MSM', 'Men', 'HIV-negative MSM in China', 'MSM participants recruited from WeChat/QQ groups', 'In total, 192 MSM']","['eHealth intervention', 'mobile phone intervention', 'Mobile Phone Intervention Based on an HIV Risk Prediction Tool for HIV Prevention']","['total clinical trial retention rate', 'rate of condom use with casual sexual partners', 'number of male sexual partners of the MSM', 'proportion of individuals intending to undergo HIV testing']","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517623', 'cui_str': '192'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0556473', 'cui_str': 'Casual sexual partner'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0036911', 'cui_str': 'Sexual partners'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}]",192.0,0.132074,"The proportion of individuals intending to undergo HIV testing after in the following 30 days was marginally higher in the intervention group than in the control group (90%, n=77/86 vs 79%, n=65/82 respectively; odds ratio 2.20, 95% CI 0.90-5.35; P=.07).","[{'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Yun', 'Affiliation': 'NHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Zhenxing', 'Initials': 'Z', 'LastName': 'Chu', 'Affiliation': 'NHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'NHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Wenqing', 'Initials': 'W', 'LastName': 'Geng', 'Affiliation': 'NHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'NHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Willa', 'Initials': 'W', 'LastName': 'Dong', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, The University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Shang', 'Affiliation': 'NHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Junjie', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'NHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}]",JMIR mHealth and uHealth,['10.2196/19511'] 3348,33846036,[Idiopathic systemic capillary leak syndrome: 2 cases with misleading presentation].,"INTRODUCTION Idiopathic systemic capillary leak syndrome (ISCLS) also known as Clarkson syndrome is a rare and sudden life-threatening entity. Three consecutive phases are described. A first non-specific prodromal phase often manifests as ""flu-like"" symptoms and precedes capillary leak phase with major hypovolemic and distributive shock leading to serious and frequent multiorgan dysfunction syndrome (MODS). Severe hypovolemia contrasts with edema, and hemoconcentration with hypoalbuminemia. ISCLS is characterized by these two clinical and biological paradoxes. Subsequent recovery phase exhibits organ function restoration along with interstitial/intravascular volumes normalization. The latter occurs spontaneously and systematically in patients surviving from leak phase. OBSERVATIONS We report here two ISCLS cases admitted in intensive care unit (ICU) both enhancing initial misdiagnosis possibly lowering prognosis and outcome. Our first 28-year-old female patient was admitted for « polycythemia vera » although hemoconcentration was attributable to hypovolemia. She presented circulatory arrest during the second bloodletting session and complicated with MODS. In and out ICU favorable outcome was noted on intravenous immunoglobulin therapy. A second 57-year-old male patient was admitted in ICU for severe ""myositis"" (myalgia and rhabdomyolysis) although rectified diagnosis retained compartment syndrome (muscular severe edema following capillary leak). Rapid and refractory hypovolemic shock appeared with subsequent MODS leading to death. CONCLUSION ISCLS pathophysiology remains unknown but certainly implies transitory endothelial dysfunction. Impossibility of randomized controlled trial for this exceptional disease led to based-on-experience therapeutic guidelines implying symptomatic care (cardiac output surveillance, nephroprotection, prudent fluid intake, prudent vasoactive amine use) and specific therapies (intravenous aminophylline during severe flares). Although enhancing controversial and even deleterious effects during the acute phase, polyvalent immunoglobulins are effective for relapse prevention. Syndromic diagnosis is difficult, but its precocious finding constitutes a key-element in better outcome before organ failure.",2021,Our first 28-year-old female patient was admitted for « polycythemia vera ,"['28-year-old female patient was admitted for «\xa0polycythemia vera', 'A second 57-year-old male patient was admitted in ICU for severe ""myositis"" (myalgia and rhabdomyolysis) although rectified diagnosis retained compartment syndrome (muscular severe edema following capillary leak']",[],[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0032463', 'cui_str': 'Polycythemia vera'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027121', 'cui_str': 'Myositis'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0035410', 'cui_str': 'Rhabdomyolysis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0009492', 'cui_str': 'Compartment syndrome'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0341950', 'cui_str': 'Severe pre-eclampsia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1382398', 'cui_str': 'Increased capillary permeability'}]",[],[],,0.0887628,Our first 28-year-old female patient was admitted for « polycythemia vera ,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bichon', 'Affiliation': ""Service de médecine interne, hôpital de la Timone, AP-HM, 264, rue Saint-Pierre, 13005 Marseille, France; Université d'Aix-Marseille, Marseille, France. Electronic address: amandine.bichon@ap-hm.fr.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Carvelli', 'Affiliation': ""Service de réanimation médicale, hôpital de la Timone, AP-HM, Marseille, France; Université d'Aix-Marseille, Marseille, France.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bourenne', 'Affiliation': ""Service de réanimation médicale, hôpital de la Timone, AP-HM, Marseille, France; Université d'Aix-Marseille, Marseille, France.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gainnier', 'Affiliation': ""Service de réanimation médicale, hôpital de la Timone, AP-HM, Marseille, France; Université d'Aix-Marseille, Marseille, France.""}, {'ForeName': 'J-R', 'Initials': 'JR', 'LastName': 'Harlé', 'Affiliation': ""Service de médecine interne, hôpital de la Timone, AP-HM, 264, rue Saint-Pierre, 13005 Marseille, France; Université d'Aix-Marseille, Marseille, France.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Schleinitz', 'Affiliation': ""Service de médecine interne, hôpital de la Timone, AP-HM, 264, rue Saint-Pierre, 13005 Marseille, France; Université d'Aix-Marseille, Marseille, France.""}]",La Revue de medecine interne,['10.1016/j.revmed.2021.03.325'] 3349,33837473,Do Standardized Scripts Improve Interpreter Use by Spanish-Speaking Patients?,"Patients with limited English-proficiency (LEP) who need but do not receive interpreters have lower satisfaction and poorer understanding. A knowledge gap remains regarding the optimal way to offer interpreters. Using standardized scripts, we will determine whether the questions we use to offer interpreters increase utilization. Pilot prospective cohort study of postpartum mothers with LEP. Subjects were assigned one of three unique scripted question offering an interpreter. Data were analyzed using ANOVA, chi-square test, and Fisher's exact test. Fifty-five LEP patients were randomized into three study arms with similar sociodemographics. Overall interpreter use was 80% (44/55). There was a significant difference in interpreter utilization: 82.4%, 63.6%, 100%, respectively by arm (p = 0.015). Highest interpreter utilization occurred with ""In what language do you prefer to receive your medical care?"". There is opportunity for providers to refine the way they offer interpreters to optimize utilization.",2021,"There was a significant difference in interpreter utilization: 82.4%, 63.6%, 100%, respectively by arm (p = 0.015).","['Fifty-five LEP patients', 'postpartum mothers with LEP', 'Patients with limited English-proficiency (LEP']",[],['interpreter utilization'],"[{'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0870816', 'cui_str': 'Limited English Proficient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0376245', 'cui_str': 'English language'}]",[],"[{'cui': 'C0150646', 'cui_str': 'Interpreter'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",55.0,0.0410432,"There was a significant difference in interpreter utilization: 82.4%, 63.6%, 100%, respectively by arm (p = 0.015).","[{'ForeName': 'Devlynne S', 'Initials': 'DS', 'LastName': 'Ondusko', 'Affiliation': 'Department of Pediatrics, Oregon Health and Science University, 707 SW Gaines Street, Portland, OR, 97239, USA. ondusko@ohsu.edu.'}, {'ForeName': 'Sheevaun', 'Initials': 'S', 'LastName': 'Khaki', 'Affiliation': 'Department of Pediatrics, Oregon Health and Science University, 707 SW Gaines Street, Portland, OR, 97239, USA.'}, {'ForeName': 'Cassidy', 'Initials': 'C', 'LastName': 'Huun', 'Affiliation': 'School of Medicine, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Krantz', 'Affiliation': 'Department of Psychology, University of Puget Sound, Tacoma, WA, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Garcia Godoy', 'Affiliation': 'School of Medicine, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Johnson', 'Affiliation': 'School of Public Health, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Cindy T', 'Initials': 'CT', 'LastName': 'McEvoy', 'Affiliation': 'Department of Pediatrics, Oregon Health and Science University, 707 SW Gaines Street, Portland, OR, 97239, USA.'}, {'ForeName': 'Ladawna L', 'Initials': 'LL', 'LastName': 'Gievers', 'Affiliation': 'Department of Pediatrics, Oregon Health and Science University, 707 SW Gaines Street, Portland, OR, 97239, USA.'}]",Journal of immigrant and minority health,['10.1007/s10903-021-01195-7'] 3350,33837458,Influences of Intermittent Pneumatic Compression Therapy on Edema and Postoperative Patient's Satisfaction After Lipoabdominoplasty.,"BACKGROUND Lipoabdominoplasty (LABP) is a frequently performed surgical procedure in the field of plastic surgery that often requires physical therapy in order to minimize postoperative complications, augment the postoperative outcomes, and enhance recovery. Intermittent pneumatic compression therapy (IPCT) is a physical therapy modality that may be used in the management of LABP population. This study aimed to assess the influences of intermittent pneumatic compression therapy on the resolution of edema and improvement in postoperative patient satisfaction following LABP. METHODS Forty-three females, aged 35-55 years, who underwent LABP, were involved in this prospective randomized study. They were divided into two groups: group A wherein 22 patients wore a compression garment (CG) for 24 h, through 4 weeks; group B wherein 21 patients wore CG besides the application of IPCT for 45 min, 3 times a week, for 4 weeks. The abdominal circumferences were measured at three positions: 3 cm above the umbilicus, at the umbilicus, and 3 cm below the umbilicus. Additionally, patient satisfaction rate was assessed by visual analog scale (VAS; in mm). All patients were assessed three times (Initial Assessment, During Assessment, and Final Assessment). RESULTS With reference to the abdominal circumferences at three levels and VAS satisfactory scores, there were statistically significant differences between both groups in Final Assessment (p < .04) in favor of group B. CONCLUSION Application of IPCT while wearing CG was superior as compared to CG alone in reducing the abdominal edema and improving postoperative patient satisfaction following LABP. LEVEL OF EVIDENCE IV This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .",2021,", there were statistically significant differences between both groups in Final Assessment (p < .04) in favor of group B. CONCLUSION Application of IPCT while wearing CG was superior as compared to CG alone in reducing the abdominal edema and improving postoperative patient satisfaction following LABP. ","['Forty-three females, aged 35-55 years, who underwent LABP']","['IV', 'Intermittent Pneumatic Compression Therapy', 'intermittent pneumatic compression therapy', 'compression garment (CG', 'Lipoabdominoplasty (LABP', 'Intermittent pneumatic compression therapy (IPCT']","['abdominal circumferences', 'patient satisfaction rate', 'abdominal edema and improving postoperative patient satisfaction', 'VAS satisfactory scores', ""Edema and Postoperative Patient's Satisfaction"", 'visual analog scale (VAS']","[{'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4704798', 'cui_str': 'Lipoabdominoplasty'}]","[{'cui': 'C1998430', 'cui_str': 'Intermittent pneumatic compression therapy'}, {'cui': 'C2985539', 'cui_str': 'Compression garment'}, {'cui': 'C4704798', 'cui_str': 'Lipoabdominoplasty'}]","[{'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0159713,", there were statistically significant differences between both groups in Final Assessment (p < .04) in favor of group B. CONCLUSION Application of IPCT while wearing CG was superior as compared to CG alone in reducing the abdominal edema and improving postoperative patient satisfaction following LABP. ","[{'ForeName': 'Nermeen Mohamed', 'Initials': 'NM', 'LastName': 'Abdelhalim', 'Affiliation': 'Department of Physical Therapy, New Kasr El-Aini Teaching Hospital, Faculty of Medicine, Cairo University, Cairo, Egypt. nermeenmohamed1976@yahoo.com.'}, {'ForeName': 'Ahmed Fathy', 'Initials': 'AF', 'LastName': 'Samhan', 'Affiliation': 'Department of Physical Therapy, New Kasr El-Aini Teaching Hospital, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",Aesthetic plastic surgery,['10.1007/s00266-021-02272-w'] 3351,33837422,Harm reduction associated with dual use of cigarettes and e-cigarettes in Black and Latino smokers: Secondary analyses from a randomized controlled e-cigarette switching trial.,"INTRODUCTION Most adult cigarette smokers who use e-cigarettes are dual cigarette and e-cigarette (CC-EC) users, yet little is known about relative consumption of cigarettes to e-cigarettes and any associated harm reduction. METHODS Rate of substitution from cigarettes to e-cigarettes at week 6 and change in biomarkers of exposure and potential harm were examined among dual CC-EC users [64/114 (56%); 35 Black, 29 Latino] in an e-cigarette switching randomized trial. RESULTS Dual users averaged 79% substitution of cigarettes for e-cigarettes at week 6, resulting in a reduction from baseline of 70.0 ± 54.1 cigarettes per week (p < .001). Total nicotine consumption remained stable (baseline: 1160.5 ± 1042.1 pg/mL of cotinine, week 6: 1312.5 ± 1725.9 pg/mL of cotinine, p = .47), while significant reductions were seen in the potent lung carcinogen 4-(methylnitrosamino)-1-(3-pyridul)-1-butanol (NNAL) (-55.9 ± 88.6 ng/ml, p < .001), carbon monoxide (-6.3 ± 8.6 ppm, p < .001), and self-reported respiratory symptoms (-3.3 ± 8.0, p = .002). No significant changes were found in blood pressure or spirometry. Greater substitution from cigarettes to e-cigarettes was associated with larger reductions in NNAL (r = -.29, p = .02). CONCLUSIONS The predominant dual use pattern was characterized by regular e-cigarette and intermittent cigarette use. Findings demonstrate the short-term harm reduction potential of this dual use pattern in Black and Latino smokers and suggest that the greatest benefit, aside from cessation of both products, is achieved by higher substitution of e-cigarettes for cigarettes. Findings need confirmation in a larger sample with longer follow-up in dual users with greater variability in rate of substitution.",2021,"Total nicotine consumption remained stable (baseline: 1160.5 ± 1042.1 pg/mL of cotinine, week 6: 1312.5 ± 1725.9 pg/mL of cotinine, p = .47), while significant reductions were seen in the potent lung carcinogen 4-(methylnitrosamino)-1-(3-pyridul)-1-butanol (NNAL) (-55.9 ± 88.6 ng/ml, p < .001), carbon monoxide (-6.3 ± 8.6 ppm, p < .001), and self-reported respiratory symptoms (-3.3 ± 8.0, p = .002).","['Rate of substitution from cigarettes to e-cigarettes at week 6 and change in biomarkers of exposure and potential harm were examined among dual CC-EC users [64/114 (56%); 35 Black, 29 Latino] in an e-cigarette switching randomized trial', 'Black and Latino smokers', 'adult cigarette smokers']",[],"['potent lung carcinogen 4-(methylnitrosamino)-1-(3-pyridul)-1-butanol (NNAL', 'carbon monoxide', 'self-reported respiratory symptoms', 'Total nicotine consumption', 'blood pressure or spirometry']","[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C4505216', 'cui_str': 'Electronic cigarette user'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}]",[],"[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0007090', 'cui_str': 'Carcinogen'}, {'cui': 'C0089147', 'cui_str': 'butyl alcohol'}, {'cui': 'C0389836', 'cui_str': '4-(methylnitrosamino)-1-(3-pyridyl)-1-butan-1-ol'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}]",,0.107234,"Total nicotine consumption remained stable (baseline: 1160.5 ± 1042.1 pg/mL of cotinine, week 6: 1312.5 ± 1725.9 pg/mL of cotinine, p = .47), while significant reductions were seen in the potent lung carcinogen 4-(methylnitrosamino)-1-(3-pyridul)-1-butanol (NNAL) (-55.9 ± 88.6 ng/ml, p < .001), carbon monoxide (-6.3 ± 8.6 ppm, p < .001), and self-reported respiratory symptoms (-3.3 ± 8.0, p = .002).","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Arnold', 'Affiliation': 'Department of Population Health, University of Kansas School of Medicine, Kansas City, KS, USA.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Nollen', 'Affiliation': 'Department of Population Health, University of Kansas School of Medicine, Kansas City, KS, USA.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Mayo', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas School of Medicine, Kansas City, KS, USA.'}, {'ForeName': 'Jasjit S', 'Initials': 'JS', 'LastName': 'Ahluwalia', 'Affiliation': 'Department of Behavioral and Social Sciences and the Center for Alcohol and Addiction Studies, School of Public Health and Alpert Medical School, Brown University, Providence, RI, USA.'}, {'ForeName': 'Eleanor L', 'Initials': 'EL', 'LastName': 'Leavens', 'Affiliation': 'Department of Population Health, University of Kansas School of Medicine, Kansas City, KS, USA.'}, {'ForeName': 'Guanlin', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas School of Medicine, Kansas City, KS, USA.'}, {'ForeName': 'Myra', 'Initials': 'M', 'LastName': 'Rice', 'Affiliation': 'Department of Psychology, California State University San Marcos, San Marcos, CA, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Pulvers', 'Affiliation': 'Department of Psychology, California State University San Marcos, San Marcos, CA, USA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntab069'] 3352,33837400,Effectiveness of tailored intervention with a salutogenic approach to improve adherence in adults with hypertension: a non-randomized trial.,"AIMS Hypertension (HTN) is a chronic long-term, slowly progressing disease. For HTN control, management, and prevention of associated complications, adequate adherence to treatment is required. It has been proposed that tailored interventions to individual needs are required to address the phenomenon of adherence to treatment. However, studies evaluating the effects of tailored interventions to improve adherence are still scarce. The aim of this study is to evaluate the effectiveness of a tailored intervention using a salutogenic approach, to improve adherence in patients with HTN. METHODS AND RESULTS A non-randomized trial design was used in this study. Adult patients with HTN were allocated in two groups: tailored intervention (n = 75) and standard care (n = 78). The content of the tailored intervention was based on personal resources and elaboration of an action plan with objectives in agreement with the patients. Patient outcomes (treatment adherence, blood pressure) were assessed both at the beginning of the study and at the 4-week follow-up for the intervention group and the standard care group. The Treatment Adherence Questionnaire for Patients with Hypertension was used to measure adherence. The results of this study showed that the total score and each dimension of the adherence questionnaire (medications, diet, physical activity, weight control, stimulation, and stress relief) increased significantly in the experimental group compared with the control group (P < 0.05). For the group assigned to tailored intervention, the delta score of the total adherence score increased in the final evaluation to 9.4 (95% CI = 8.60-10.28). CONCLUSION A tailored intervention with a salutogenic approach appears to be effective for improving adherence in patients with HTN. Randomized controlled trials are required to confirm the effect of tailored interventions in this type of population.",2021,"For the group assigned to tailored intervention, the delta score of the total adherence score increased in the final evaluation to 9.4 (95% CI = 8.60-10.28). ","['Adult patients with HTN', 'Patients with Hypertension', 'adults with hypertension', 'patients with HTN']","['tailored intervention with a salutogenic approach', 'tailored intervention (n\u2009=\u200975) and standard care']","['delta score of the total adherence score', 'total score and each dimension of the adherence questionnaire (medications, diet, physical activity, weight control, stimulation, and stress relief', 'Patient outcomes (treatment adherence, blood pressure']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",,0.0102472,"For the group assigned to tailored intervention, the delta score of the total adherence score increased in the final evaluation to 9.4 (95% CI = 8.60-10.28). ","[{'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Esquivel Garzón', 'Affiliation': 'Department of Clinical Sciences, Cl. 42 # 1B-1, Universidad del Tolima, Ibagué, 730001, Colombia.'}, {'ForeName': 'Luz Patricia', 'Initials': 'LP', 'LastName': 'Díaz Heredia', 'Affiliation': 'Faculty of Nursing, Universidad Nacional de Colombia, Cra.30 #45-03 Ciudad Universitaria. Edificio 228, Piso 3, Of. 306, Bogotá, 111321, Colombia.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Grisales Romero', 'Affiliation': 'Demography and Health Research Group, National School of Public Health, Universidad de Antioquia, Cl. 62 #52-59, Medellín, 050010, Colombia.'}, {'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Cañon-Montañez', 'Affiliation': 'Faculty of Nursing, Universidad de Antioquia, Cl. 64 #53-09, Medellín, 050010, Colombia.'}]",European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology,['10.1093/eurjcn/zvab030'] 3353,33837106,CopenFast trial: Faster-acting insulin Fiasp versus insulin NovoRapid in the treatment of women with type 1 or type 2 diabetes during pregnancy and lactation - a randomised controlled trial.,"INTRODUCTION Faster-acting insulin aspart (Fiasp) is approved for use in pregnancy and lactation, but no clinical study has evaluated its effects during this life stage in women with pre-existing diabetes. The aim of the CopenFast trial is to evaluate the effect of Fiasp compared with insulin aspart (NovoRapid) on maternal glycaemic control during pregnancy, delivery and lactation and on fetal growth and infant health. METHODS AND ANALYSIS An open-label randomised controlled trial of pregnant women with type 1 or type 2 diabetes including women on multiple daily injection (MDI) therapy or insulin pump therapy. During a 2-year inclusion period, approximately 220 women will be randomised 1:1 to Fiasp or NovoRapid in early pregnancy and followed until 3 months after delivery. At 9, 21 and 33 gestational weeks and during planned induction of labour or caesarean section, women are offered blinded continuous glucose monitoring (CGM) for 7 days. Randomisation will stratify for type of diabetes and insulin treatment modality (MDI or insulin pump therapy, respectively). Health status of the infants will be followed until 3 months of age. The primary outcome is birth weight SD score adjusted for gestational age and gender. Secondary outcomes include maternal glycaemic control including glycated haemoglobin, preprandial and postprandial self-monitored plasma glucose levels, episodes of mild and severe hypoglycaemia, maternal gestational weight gain and weight retention, CGM time spent in, above and below target ranges as well as pregnancy outcomes including pre-eclampsia, preterm delivery, perinatal mortality and neonatal morbidity. Data analysis will be performed according to the intention-to-treat principle. ETHICS AND DISSEMINATION The trial has been approved by the Regional Ethics Committee (H-19029966) on 7 August 2019. Results will be sought disseminated in peer-reviewed journals and at scientific meetings. TRIAL REGISTRATION NUMBER NCT03770767.",2021,"Secondary outcomes include maternal glycaemic control including glycated haemoglobin, preprandial and postprandial self-monitored plasma glucose levels, episodes of mild and severe hypoglycaemia, maternal gestational weight gain and weight retention, CGM time spent in, above and below target ranges as well as pregnancy outcomes including pre-eclampsia, preterm delivery, perinatal mortality and neonatal morbidity.","['pregnant women with type 1 or type 2 diabetes including women on', 'women with pre-existing diabetes', '220 women', 'women with type 1 or type 2 diabetes during pregnancy and lactation ']","['multiple daily injection (MDI) therapy or insulin pump therapy', 'Fiasp compared with insulin aspart (NovoRapid', 'Faster-acting insulin aspart (Fiasp', 'Faster-acting insulin Fiasp versus insulin NovoRapid', 'Fiasp or NovoRapid']","['maternal glycaemic control during pregnancy, delivery and lactation and on fetal growth and infant health', 'birth weight SD score adjusted for gestational age and gender', 'maternal glycaemic control including glycated haemoglobin, preprandial and postprandial self-monitored plasma glucose levels, episodes of mild and severe hypoglycaemia, maternal gestational weight gain and weight retention, CGM time spent in, above and below target ranges as well as pregnancy outcomes including pre-eclampsia, preterm delivery, perinatal mortality and neonatal morbidity']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0939412', 'cui_str': 'NovoRapid'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0743925', 'cui_str': 'Fetal Growth'}, {'cui': 'C0205806', 'cui_str': 'Baby Health'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1550738', 'cui_str': 'Before food'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0031062', 'cui_str': 'Perinatal Mortality'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",,0.226255,"Secondary outcomes include maternal glycaemic control including glycated haemoglobin, preprandial and postprandial self-monitored plasma glucose levels, episodes of mild and severe hypoglycaemia, maternal gestational weight gain and weight retention, CGM time spent in, above and below target ranges as well as pregnancy outcomes including pre-eclampsia, preterm delivery, perinatal mortality and neonatal morbidity.","[{'ForeName': 'Sidse Kjærhus', 'Initials': 'SK', 'LastName': 'Nørgaard', 'Affiliation': 'Center for Pregnant Women with Diabetes, Rigshospitalet, Copenhagen, Denmark sidse.kjaerhus.noergaard.01@regionh.dk.'}, {'ForeName': 'Elisabeth Reinhardt', 'Initials': 'ER', 'LastName': 'Mathiesen', 'Affiliation': 'Center for Pregnant Women with Diabetes, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Nørgaard', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Tine Dalsgaard', 'Initials': 'TD', 'LastName': 'Clausen', 'Affiliation': 'Department of Clinical Medicine, University of Copenhagen Faculty of Health and Medical Sciences, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Damm', 'Affiliation': 'Center for Pregnant Women with Diabetes, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Ringholm', 'Affiliation': 'Center for Pregnant Women with Diabetes, Rigshospitalet, Copenhagen, Denmark.'}]",BMJ open,['10.1136/bmjopen-2020-045650'] 3354,33837098,Effects of an optimised approach to home-based respiratory care in individuals with amyotrophic lateral sclerosis: a study protocol for a randomised controlled trial.,"INTRODUCTION This study aims to investigate the effects of an optimal home-based respiratory care protocol in individuals with amyotrophic lateral sclerosis (ALS). METHODS AND ANALYSIS This is a randomised, blinded controlled trial involving patients diagnosed with ALS, both sexes, age between 18 and 80 years. Patients will be randomly allocated into the conventional respiratory care (CRC) group and the optimised respiratory care home-based (ORC) group. Primary outcomes will be peak cough flow, the number of exacerbations and ALS Functional Rating Scale Revised. Secondary outcomes will include chest wall volumes, maximal respiratory pressures, sniff nasal inspiratory pressure, nasal expiratory pressure and forced vital capacity (FVC), forced expiratory volume in the 1st second (FEV 1 ) and FEV 1 /FVC. The CRC group will receive educational information about respiratory care at the clinic. The ORC group will receive conventional care and home-based care. The clinical status of all individuals will be monitored weekly through telephone calls. A 6-month intervention is planned, the outcomes will be assessed every 3 months and 3 and 6 months follow-up after final evaluation. The primary and secondary results will be described as average or median for continuous variables and absolute and relative frequencies for qualitative variables. Treatment effects or differences between the outcomes (baseline, 3 months and 6 months) of the study groups will be analysed using an analysis of variance. The level of significance will be set as p≤0.05. ETHICS AND DISSEMINATION The research ethics committee approved the study. It is expected to evaluate respiratory function in patients with ALS in the short, medium and long terms with home-based care protocol applied. The disease's rapid progression is a limitation for performing a long-term clinical study. TRIAL REGISTRATION NUMBER RBR-3z23ts; Pre-results.",2021,"This study aims to investigate the effects of an optimal home-based respiratory care protocol in individuals with amyotrophic lateral sclerosis (ALS). ","['individuals with amyotrophic lateral sclerosis', 'patients with ALS', 'patients diagnosed with ALS, both sexes, age between 18 and 80 years', 'individuals with amyotrophic lateral sclerosis (ALS']","['optimised approach to home-based respiratory care', 'conventional respiratory care (CRC) group and the optimised respiratory care home-based (ORC) group', 'optimal home-based respiratory care protocol']","['peak cough flow, the number of exacerbations and ALS Functional Rating Scale Revised', 'chest wall volumes, maximal respiratory pressures, sniff nasal inspiratory pressure, nasal expiratory pressure and forced vital capacity (FVC), forced expiratory volume in the 1st second (FEV 1 ) and FEV 1 /FVC', 'average or median for continuous variables and absolute and relative frequencies for qualitative variables']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002736', 'cui_str': 'Amyotrophic lateral sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035239', 'cui_str': 'Respiratory therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4296567', 'cui_str': 'Amyotrophic Lateral Sclerosis Functional Rating Scale Revised'}, {'cui': 'C0205076', 'cui_str': 'Chest wall structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C4277579', 'cui_str': 'Maximal Respiratory Pressure'}, {'cui': 'C1720573', 'cui_str': 'Sniff'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0042834', 'cui_str': 'Vital capacity'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}]",,0.13878,"This study aims to investigate the effects of an optimal home-based respiratory care protocol in individuals with amyotrophic lateral sclerosis (ALS). ","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Pondofe', 'Affiliation': 'Departamento de Fisioterapia, PneumoCardioVascular Lab/HUOL e Laboratório de Inovação Tecnológica em Reabilitação, Hospital Universitário Onofre Lopes, Empresa Brasileira de Serviços Hospitalares (EBSERH), Universidade Federal do Rio Grande do Norte, Natal, Brazil karenpondofe@yahoo.com.br.'}, {'ForeName': 'Guilherme A F', 'Initials': 'GAF', 'LastName': 'Fregonezi', 'Affiliation': 'Departamento de Fisioterapia, PneumoCardioVascular Lab/HUOL e Laboratório de Inovação Tecnológica em Reabilitação, Hospital Universitário Onofre Lopes, Empresa Brasileira de Serviços Hospitalares (EBSERH), Universidade Federal do Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Ozana', 'Initials': 'O', 'LastName': 'Brito', 'Affiliation': 'Departamento de Fisioterapia, PneumoCardioVascular Lab/HUOL e Laboratório de Inovação Tecnológica em Reabilitação, Hospital Universitário Onofre Lopes, Empresa Brasileira de Serviços Hospitalares (EBSERH), Universidade Federal do Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Mario Emilio', 'Initials': 'ME', 'LastName': 'Dourado Júnior', 'Affiliation': 'Medicina Integrada, Hospital Universitário Onofre Lopes, Empresa Brasileira de Serviços Hospitalares (EBSERH), Universidade Federal do Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Torres-Castro', 'Affiliation': 'Departamento de Kinesiología, Universidad de Chile, Santiago de Chile, Chile.'}, {'ForeName': 'Vanessa R', 'Initials': 'VR', 'LastName': 'Resqueti', 'Affiliation': 'Departamento de Fisioterapia, PneumoCardioVascular Lab/HUOL e Laboratório de Inovação Tecnológica em Reabilitação, Hospital Universitário Onofre Lopes, Empresa Brasileira de Serviços Hospitalares (EBSERH), Universidade Federal do Rio Grande do Norte, Natal, Brazil.'}]",BMJ open,['10.1136/bmjopen-2020-042780'] 3355,33837097,Study protocol for You.Mind!: boosting first-line mental health care for YOUngsters suffering from chronic conditions with mindfulness: a randomised staggered within-subjects design.,"INTRODUCTION Adolescents with chronic conditions often experience high levels of stress, anxiety and depression, and reduced quality of life. Mindfulness-based interventions (MBIs) have been found to improve emotional distress in clinical and non-clinical populations and are a promising technique to support adolescents with chronic conditions in managing their symptoms and ultimately enhance their quality of life. METHODS AND ANALYSIS To test the effects of an MBI on emotional distress and quality of life and delineate the underlying mechanisms, the You.Mind! study uses a randomised staggered within-subjects design. Thirty adolescents with a chronic condition will be randomised to a baseline phase of 14-28 days followed by an MBI, consisting of four online group sessions and online support spread over 8 weeks. Outcomes will be assessed by short, repeated measurements throughout the baseline, intervention and follow-up phases and by standardised questionnaires and experience sampling measures before randomisation, at postintervention and at 3-months follow-up. Analysis will be based on general linear modelling and multilevel mixed-effects modelling. ETHICS AND DISSEMINATION Ethical approval was obtained from the Ethics Committee Research UZ/KU Leuven and the Ethics Committee of Ghent University Hospital and Ghent University (S63485). Results will be disseminated through presentations at public lectures, scientific institutions and meetings, and through publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER NCT04359563.",2021,"Mindfulness-based interventions (MBIs) have been found to improve emotional distress in clinical and non-clinical populations and are a promising technique to support adolescents with chronic conditions in managing their symptoms and ultimately enhance their quality of life. ","['Thirty adolescents with a chronic condition', 'YOUngsters suffering from chronic conditions with mindfulness']","['Mindfulness-based interventions (MBIs', 'MBI', ' boosting first-line mental health care']","['emotional distress and quality of life', 'emotional distress']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2985547', 'cui_str': 'Scintimammography'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}]","[{'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",30.0,0.132306,"Mindfulness-based interventions (MBIs) have been found to improve emotional distress in clinical and non-clinical populations and are a promising technique to support adolescents with chronic conditions in managing their symptoms and ultimately enhance their quality of life. ","[{'ForeName': 'Merle', 'Initials': 'M', 'LastName': 'Kock', 'Affiliation': 'Leuven Mindfulness Centre, KU Leuven, Leuven, Belgium merle.kock@kuleuven.be.'}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Van Hoecke', 'Affiliation': 'Department of Internal Medicine and Pediatrics, University Hospital Ghent, Gent, Belgium.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Raes', 'Affiliation': 'Leuven Mindfulness Centre, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Katleen', 'Initials': 'K', 'LastName': 'Van der Gucht', 'Affiliation': 'Leuven Mindfulness Centre, KU Leuven, Leuven, Belgium.'}]",BMJ open,['10.1136/bmjopen-2020-042648'] 3356,33837095,Improving the patient-centred care of children with life-altering skin conditions using feedback from electronic patient-reported outcome measures: protocol for a hybrid effectiveness-implementation study (PEDS-ePROM).,"INTRODUCTION Using patient-reported outcome measures (PROMs) with children have been described as 'giving a voice to the child'. Few studies have examined the routine use of these measures as potentially therapeutic interventions. This study aims to investigate: (1) the effectiveness of feedback using graphical displays of information from electronic PROMs (ePROMs) that target health-related quality of life, to improve health outcomes, referrals and treatment satisfaction and (2) the implementation of ePROMs and graphical displays by assessing acceptability, sustainability, cost, fidelity and context of the intervention and study processes. METHODS AND ANALYSIS A hybrid II effectiveness-implementation study will be conducted from February 2020 with children with life-altering skin conditions attending two outpatient clinics at a specialist paediatric children's hospital. A pragmatic randomised controlled trial and mixed methods process evaluation will be completed. Randomisation will occur at the child participant level. Children or parent proxies completing baseline ePROMs will be randomised to: (1) completion of ePROMs plus graphical displays of ePROM results to treating clinicians in consultations, versus (2) completion of ePROMs without graphical display of ePROM results. The primary outcome of the effectiveness trial will be overall health-related quality of life of children. Secondary outcomes will include other health-related quality of life outcomes (eg, child psychosocial and physical health, parent psychosocial health), referrals and treatment satisfaction. Trial data will be primarily analysed using linear mixed-effects models; and implementation data using inductive thematic analysis of interviews, meeting minutes, observational field notes and study communication mapped to the Consolidated Framework for Implementation Research. ETHICS AND DISSEMINATION Ethical approval was obtained from Children's Health Queensland Human Research Ethics Committee (HREC/2019/QCHQ/56290), The University of Queensland (2019002233) and Queensland University of Technology (1900000847). Dissemination will occur through stakeholder groups, scientific meetings and peer-reviewed publications. TRIAL REGISTRATION NUMBER Australian New Zealand Clinical Trials Registry (ACTRN12620000174987).",2021,"Children or parent proxies completing baseline ePROMs will be randomised to: (1) completion of ePROMs plus graphical displays of ePROM results to treating clinicians in consultations, versus (2) completion of ePROMs without graphical display of ePROM results.","[""February 2020 with children with life-altering skin conditions attending two outpatient clinics at a specialist paediatric children's hospital""]",['feedback using graphical displays of information from electronic PROMs (ePROMs'],"['health-related quality of life outcomes (eg, child psychosocial and physical health, parent psychosocial health), referrals and treatment satisfaction', 'acceptability, sustainability, cost, fidelity and context', 'overall health-related quality of life of children']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0037274', 'cui_str': 'Disorder of skin'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]",,0.166262,"Children or parent proxies completing baseline ePROMs will be randomised to: (1) completion of ePROMs plus graphical displays of ePROM results to treating clinicians in consultations, versus (2) completion of ePROMs without graphical display of ePROM results.","[{'ForeName': 'Zephanie', 'Initials': 'Z', 'LastName': 'Tyack', 'Affiliation': ""Centre for Children's Burns and Trauma Research, Child Health Research Centre, The University of Queensland, Saint Lucia, Queensland, Australia z.tyack@qut.edu.au.""}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Simons', 'Affiliation': ""Centre for Children's Burns and Trauma Research, Child Health Research Centre, The University of Queensland, Saint Lucia, Queensland, Australia.""}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'McPhail', 'Affiliation': 'Australian Centre for Health Services Innovation, Centre for Healthcare Transformation, School of Public Health and Social Work, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Harvey', 'Affiliation': 'Adelaide Nursing School, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Zappala', 'Affiliation': ""General Paediatrics and Dermatology Department, Queensland Children's Hospital, South Brisbane, Queensland, Australia.""}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Ware', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University - GC Campus, Southport, Queensland, Australia.'}, {'ForeName': 'Roy M', 'Initials': 'RM', 'LastName': 'Kimble', 'Affiliation': ""Centre for Children's Burns and Trauma Research, Child Health Research Centre, The University of Queensland, Saint Lucia, Queensland, Australia.""}]",BMJ open,['10.1136/bmjopen-2020-041861'] 3357,33837086,Ketogenic diet reduces alcohol withdrawal symptoms in humans and alcohol intake in rodents.,"Individuals with alcohol use disorder (AUD) show elevated brain metabolism of acetate at the expense of glucose. We hypothesized that a shift in energy substrates during withdrawal may contribute to withdrawal severity and neurotoxicity in AUD and that a ketogenic diet (KD) may mitigate these effects. We found that inpatients with AUD randomized to receive KD ( n = 19) required fewer benzodiazepines during the first week of detoxification, in comparison to those receiving a standard American (SA) diet ( n = 14). Over a 3-week treatment, KD compared to SA showed lower ""wanting"" and increased dorsal anterior cingulate cortex (dACC) reactivity to alcohol cues and altered dACC bioenergetics (i.e., elevated ketones and glutamate and lower neuroinflammatory markers). In a rat model of alcohol dependence, a history of KD reduced alcohol consumption. We provide clinical and preclinical evidence for beneficial effects of KD on managing alcohol withdrawal and on reducing alcohol drinking.",2021,"Over a 3-week treatment, KD compared to SA showed lower ""wanting"" and increased dorsal anterior cingulate cortex (dACC) reactivity to alcohol cues and altered dACC bioenergetics (i.e., elevated ketones and glutamate and lower neuroinflammatory markers).","['Individuals with alcohol use disorder (AUD', 'humans and alcohol intake in rodents']","['KD', 'benzodiazepines during the first week of detoxification, in comparison to those receiving a standard American (SA) diet', 'Ketogenic diet']","['lower ""wanting"" and increased dorsal anterior cingulate cortex (dACC) reactivity to alcohol cues and altered dACC bioenergetics (i.e., elevated ketones and glutamate and lower neuroinflammatory markers', 'alcohol withdrawal symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0035804', 'cui_str': 'Order Rodentia'}]","[{'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0025516', 'cui_str': 'Detoxication, Drug, Metabolic'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0005486', 'cui_str': 'Bioenergetics'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0236663', 'cui_str': 'Alcohol withdrawal syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0132023,"Over a 3-week treatment, KD compared to SA showed lower ""wanting"" and increased dorsal anterior cingulate cortex (dACC) reactivity to alcohol cues and altered dACC bioenergetics (i.e., elevated ketones and glutamate and lower neuroinflammatory markers).","[{'ForeName': 'Corinde E', 'Initials': 'CE', 'LastName': 'Wiers', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD 20892, USA. corinde.wiers@pennmedicine.upenn.edu leandro.vendruscolo@nih.gov nvolkow@nida.nih.gov.'}, {'ForeName': 'Leandro F', 'Initials': 'LF', 'LastName': 'Vendruscolo', 'Affiliation': 'National Institute on Drug Abuse, Baltimore, MD 21224, USA. corinde.wiers@pennmedicine.upenn.edu leandro.vendruscolo@nih.gov nvolkow@nida.nih.gov.'}, {'ForeName': 'Jan-Willem', 'Initials': 'JW', 'LastName': 'van der Veen', 'Affiliation': 'National Institute of Mental Health, Bethesda, MD 20892, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Manza', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD 20892, USA.'}, {'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Shokri-Kojori', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD 20892, USA.'}, {'ForeName': 'Danielle S', 'Initials': 'DS', 'LastName': 'Kroll', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD 20892, USA.'}, {'ForeName': 'Dana E', 'Initials': 'DE', 'LastName': 'Feldman', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD 20892, USA.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'McPherson', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD 20892, USA.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Biesecker', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD 20892, USA.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD 20892, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Herman', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD 20892, USA.'}, {'ForeName': 'Sophie K', 'Initials': 'SK', 'LastName': 'Elvig', 'Affiliation': 'National Institute on Drug Abuse, Baltimore, MD 21224, USA.'}, {'ForeName': 'Janaina C M', 'Initials': 'JCM', 'LastName': 'Vendruscolo', 'Affiliation': 'National Institute on Drug Abuse, Baltimore, MD 21224, USA.'}, {'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Turner', 'Affiliation': 'Clinical Center Nutrition Department, National Institutes of Health, Bethesda, MD 20892, USA.'}, {'ForeName': 'Shanna', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Clinical Center Nutrition Department, National Institutes of Health, Bethesda, MD 20892, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Schwandt', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD 20892, USA.'}, {'ForeName': 'Dardo', 'Initials': 'D', 'LastName': 'Tomasi', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD 20892, USA.'}, {'ForeName': 'Mackenzie C', 'Initials': 'MC', 'LastName': 'Cervenka', 'Affiliation': 'Department of Neurology, Johns Hopkins University, Baltimore, MD 21287, USA.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Fink-Jensen', 'Affiliation': 'Psychiatric Centre Copenhagen, University Hospital of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Benveniste', 'Affiliation': 'Department of Anesthesiology, Yale University, New Haven, CT 06519, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Diazgranados', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD 20892, USA.'}, {'ForeName': 'Gene-Jack', 'Initials': 'GJ', 'LastName': 'Wang', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD 20892, USA.'}, {'ForeName': 'George F', 'Initials': 'GF', 'LastName': 'Koob', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD 20892, USA.'}, {'ForeName': 'Nora D', 'Initials': 'ND', 'LastName': 'Volkow', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD 20892, USA. corinde.wiers@pennmedicine.upenn.edu leandro.vendruscolo@nih.gov nvolkow@nida.nih.gov.'}]",Science advances,['10.1126/sciadv.abf6780'] 3358,33836990,Systemic conbercept pharmacokinetics and VEGF pharmacodynamics following intravitreal injections of conbercept in patients with retinopathy of prematurity.,"BACKGROUND Data on serum vascular endothelial growth factor (VEGF) and drug levels in patients with retinopathy of prematurity (ROP) following intravitreal injections of conbercept (IVC) are lacking. METHODS Multicentre, prospective, non-randomised study of patients with aggressive posterior retinopathy of prematurity (APROP) or type 1 ROP who had not received other treatment. All infants received therapy in both eyes plus intravitreal IVC 0.25 mg/0.025 mL in one eye and had at least 6 months of follow-up. Blood samples were collected before and 1 week and 4 weeks after IVC. The main outcome measures were serum conbercept and VEGF concentrations. RESULTS Forty infants with APROP or type 1 ROP were enrolled. The mean serum VEGF at baseline and 1 week and 4 weeks after a total of 0.25 mg of IVC was 953.35±311.90 pg/mL, 303.46±181.89 pg/mL and 883.12±303.89 pg/mL, respectively. Serum VEGF 1 week after IVC was significantly lower (p < 0.05) than baseline, and at 4 weeks after IVC, it was significantly higher (p < 0.05) than at 1 week. There was no significant difference (p > 0.05) between baseline and 4 weeks. Serum conbercept was below the limit of quantitation (BLOQ) at baseline and 4 weeks and was 19.81±7.60 ng/mL at 1 week. CONCLUSION Serum VEGF 1 week after IVC was significantly lower than baseline but returned to baseline at 4 weeks. Serum conbercept increased at 1 week and was BLOQ at 4 weeks.",2021,"Serum VEGF 1 week after IVC was significantly lower (p < 0.05) than baseline, and at 4 weeks after IVC, it was significantly higher (p < 0.05) than at 1 week.","['Forty infants with APROP or type 1 ROP were enrolled', 'patients with retinopathy of prematurity (ROP', 'patients with retinopathy of prematurity', 'patients with aggressive posterior retinopathy of prematurity (APROP) or type 1 ROP who had not received other treatment']","['intravitreal injections of conbercept (IVC', 'intravitreal injections of conbercept']","['serum conbercept and VEGF concentrations', 'Serum conbercept', 'Serum VEGF', 'mean serum VEGF', 'Blood samples']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0035344', 'cui_str': 'Retinopathy of prematurity'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",40.0,0.0639925,"Serum VEGF 1 week after IVC was significantly lower (p < 0.05) than baseline, and at 4 weeks after IVC, it was significantly higher (p < 0.05) than at 1 week.","[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': ""Department of Ophthalmology, Peking University People's Hospital, Eye diseases and Optometry Institute, Beijing Key Laboratory of Diagnosis and Therapy of Retinal and Choroid Diseases, Clinical Centre of Optometry, College of Optometry, Peking University Health science center, Beijing, China.""}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': ""Department of Ophthalmology,Children's Hospital Affiliated to Zhengzhou University, Henan Children's Hospital, Zhengzhou Children's Hospital, Zhengzhou, China.""}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': ""Department of Ophthalmology, Peking University People's Hospital, Eye diseases and Optometry Institute, Beijing Key Laboratory of Diagnosis and Therapy of Retinal and Choroid Diseases, Clinical Centre of Optometry, College of Optometry, Peking University Health science center, Beijing, China.""}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': ""Department of Ophthalmology, Peking University People's Hospital, Eye diseases and Optometry Institute, Beijing Key Laboratory of Diagnosis and Therapy of Retinal and Choroid Diseases, Clinical Centre of Optometry, College of Optometry, Peking University Health science center, Beijing, China.""}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Linghu', 'Affiliation': ""Department of Ophthalmology, Peking University People's Hospital, Eye diseases and Optometry Institute, Beijing Key Laboratory of Diagnosis and Therapy of Retinal and Choroid Diseases, Clinical Centre of Optometry, College of Optometry, Peking University Health science center, Beijing, China.""}, {'ForeName': 'Xiantao', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': ""Department of Ophthalmology,Children's Hospital Affiliated to Zhengzhou University, Henan Children's Hospital, Zhengzhou Children's Hospital, Zhengzhou, China drliangjianhong@126.com drxiantaosun@126.com.""}, {'ForeName': 'Jianhong', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': ""Department of Ophthalmology, Peking University People's Hospital, Eye diseases and Optometry Institute, Beijing Key Laboratory of Diagnosis and Therapy of Retinal and Choroid Diseases, Clinical Centre of Optometry, College of Optometry, Peking University Health science center, Beijing, China drliangjianhong@126.com drxiantaosun@126.com.""}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2021-319131'] 3359,33836985,Does a peer social support group intervention using the cares skills framework improve emotional expression and emotion-focused coping in paramedic students?,"There is growing concern for the health and wellbeing of paramedic students who are required to undertake work integrated learning (WIL) in the ambulance setting to become a registered paramedic. Paramedic culture, barriers to help seeking, and difficulty in accessing peer support is limiting their ability to express emotions and cope with workplace stress. This study aimed to examine whether participation in a peer social support group, using the CARES skills framework, changed paramedic students' emotional expression and emotion-focused coping. A convenience sample of seventy-eight participants were recruited from a paramedic program at a single regional university in Australia. Due to small participant numbers third year students were assigned to the intervention group (n = 44) and second year students were assigned to the control group (n = 34). The intervention group received training on how to undertake a peer social support group using the skills embedded in the CARES framework and were encouraged to meet every two weeks over a twelve-week period. All participants completed online surveys consisting of the DASS-21 stress subscale, General Help Seeking Questionnaire, Emotional Approach Coping Scale, Emotional Expressivity Scale and Multidimensional Scale of Perceived Social Support in week 1 and in week 12. Findings suggest that peer social support participation significantly increased emotional expression and emotion-focused coping when compared to the control group. Furthermore, this intervention significantly reduced participants' reliance upon help seeking without a significant increase in external social support. This is the first known study to investigate the role of peer social support amongst paramedic students, and the findings provide new information on how to help individuals cope with the stressors of working in the ambulance setting. Future studies should investigate whether the positive effects of peer social support are consistent over time and focus on minimising sampling issues.",2021,Findings suggest that peer social support participation significantly increased emotional expression and emotion-focused coping when compared to the control group.,"['A convenience sample of seventy-eight participants were recruited from a paramedic program at a single regional university in Australia', 'paramedic students']",['training on how to undertake a peer social support group using the skills embedded in the CARES framework'],"['external social support', 'General Help Seeking Questionnaire, Emotional Approach Coping Scale, Emotional Expressivity Scale and Multidimensional Scale of Perceived Social Support', 'emotional expression and emotion-focused coping']","[{'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}]",78.0,0.0229447,Findings suggest that peer social support participation significantly increased emotional expression and emotion-focused coping when compared to the control group.,"[{'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Pinks', 'Affiliation': 'Caboolture Hospital, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Warren-James', 'Affiliation': 'The University of the Sunshine Coast, 90 Sippy Downs Dr, Sippy Downs, QLD 4556, Australia. Electronic address: matthew.warren-james@usc.edu.au.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Katsikitis', 'Affiliation': 'Flinders University, Sturt Rd, Bedford Park, SA, 5042, Australia. Electronic address: mary.katsikitis@flinders.edu.au.'}]",Australasian emergency care,['10.1016/j.auec.2021.03.005'] 3360,33836963,Analgesic Efficacy of Regional Anesthesia of the Hemithorax in Patients Undergoing Subcutaneous Implantable Cardioverter-Defibrillator Placement.,"OBJECTIVES Patients undergoing subcutaneous implantable cardioverter-defibrillator (S-ICD) placement usually experience substantial perioperative pain. The aim of the present study was to investigate the effect of transversus thoracic muscle plane block combined with serratus anterior plane block in patients undergoing S-ICD placement. DESIGN Double-blind, randomized controlled study. SETTING First Affiliated Hospital of Nanchang University. PARTICIPANTS Patients aged 18-to-80 years who underwent new S-ICD placement. INTERVENTIONS A group of 80 patients randomly were allocated to either the regional group (R group) or local group (L group). MEASUREMENTS AND MAIN RESULTS The primary endpoint was pain during S-ICD placement. The secondary outcome measures included pain intensity at rest and after movement one, three, six, 12, 24, and 48 hours after surgery; the dose of dexmedetomidine and remifentanil during surgery; 24-hour ketorolac administration; postoperative sufentanil dosage; the total duration of hospitalization; intraoperative sedation; and the incidence of hypoxemia. Mean Critical-Care Pain Observation Tool scores were significantly higher during pocket creation, lead tunneling A, and lead tunneling B in the L group compared with the R group. The R group required significantly less intraoperative dexmedetomidine, intraoperative remifentanil, postoperative sufentanil, and ketorolac consumption. Compared with the R group, the L group had higher Numerical Rating Scale pain scores at 24 hours after surgery both at rest and after movement. The intraoperative Ramsay score and the incidence of hypoxemia were significantly higher in the L group compared with the R group. CONCLUSIONS Ultrasound-guided transversus thoracic muscle plane block and serratus anterior plane block resulted in lower intraoperative Critical-Care Pain Observation Tool scores and the need for less adjunctive pain medication and sedation compared with local anesthesia in patients undergoing S-ICD placement.",2021,"The intraoperative Ramsay score and the incidence of hypoxemia were significantly higher in the L group compared with the R group. ","['Patients undergoing', 'patients undergoing S-ICD placement', 'Patients aged 18-to-80 years who underwent new S-ICD placement', 'Patients Undergoing Subcutaneous Implantable Cardioverter-Defibrillator Placement', 'First Affiliated Hospital of Nanchang University', '80 patients randomly']","['dexmedetomidine', 'remifentanil', 'transversus thoracic muscle plane block combined with serratus anterior plane block', 'local anesthesia', 'subcutaneous implantable cardioverter-defibrillator (S-ICD) placement', 'Regional Anesthesia of the Hemithorax', 'regional group (R group) or local group (L group', 'Ultrasound-guided transversus thoracic muscle plane block and serratus anterior plane block']","['Analgesic Efficacy', 'pain during S-ICD placement', 'total duration of hospitalization; intraoperative sedation; and the incidence of hypoxemia', 'Mean Critical-Care Pain Observation Tool scores', 'Numerical Rating Scale pain scores', 'intraoperative dexmedetomidine, intraoperative remifentanil, postoperative sufentanil, and ketorolac consumption', 'intraoperative Ramsay score and the incidence of hypoxemia', 'pain intensity at rest and after movement one']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0224337', 'cui_str': 'Skeletal muscle structure of thorax'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0224349', 'cui_str': 'Structure of serratus anterior muscle'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C1827591', 'cui_str': 'Structure of half of thorax lateral to midsagittal plane'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",80.0,0.547306,"The intraoperative Ramsay score and the incidence of hypoxemia were significantly higher in the L group compared with the R group. ","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Nanchang University, Jiangxi, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Min', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Nanchang University, Jiangxi, China.'}, {'ForeName': 'Shibiao', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Nanchang University, Jiangxi, China. Electronic address: chenlaoshi1111@163.com.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2021.02.052'] 3361,33836814,Comparison of single-injection ultrasound-guided thoracic paravertebral block with transversus abdominis plane block in peritoneal dialysis catheter implantation: a randomized controlled trial.,"BACKGROUND Previous study indicated that transversus abdominis plane (TAP) block could be the principal anesthetic technique for peritoneal dialysis catheter (PDC) implantations. However, a TAP block could not provide an optimal anesthetic effect on catheter exit site during PDC implantation. We hypothesized that single-injection ultrasound-guided thoracic paravertebral block (US-TPVB) could be the principal anesthetic technique with better pain relief at catheter exit site during PDC implantation, compared to a TAP block. And anesthesia quality of a single-injection US-TPVB was compared with that of a TAP block and local anesthetic infiltration (LAI). METHODS Patients undergoing PDC implantations were randomized into groups TPVB or TAP or LAI. In group TPVB, single-injection US-TPVB at T10-T11 level was performed with 20 ml of 0.25% ropivacaine. In group TAP, oblique subcostal TAP block was performed with 20 ml of 0.25% ropivacaine. In group LAI, 40 ml of 0.25% ropivacaine was used. Anesthesia quality was compared among the three groups, including general anesthesia conversion rate, cumulative rescuing sufentanil consumption, and satisfaction rate by nephrologists and patients. RESULTS Eighty-eight eligible patients were enrolled. Visual analogue scale (VAS) at most time points (except for the catheter exit site) were lower in group TAP, compared with group TPVB. VAS at parietal peritoneum manipulation was 6 (5, 7), 3 (0, 6), and 7 (4.75, 9) in groups TPVB, TAP, and LAI, respectively (P < 0.001). VAS at catheter exit site was 4 (3, 4), 5.5 (4, 8), and 5 (3, 7.25) in groups TPVB, TAP, and LAI, respectively (P = 0.005). Lower general anesthesia conversion rate, less cumulative rescuing sufentanil consumption, and higher satisfaction rates by nephrologists and patients were recorded in group TAP, compared with groups TPVB and LAI. CONCLUSIONS Single-injection US-TPVB provided a better pain relief at catheter exit site. The quality and reliability of anesthesia after a single-injection US-TPVB was comparable to that of LAI, but not better than that of an oblique subcostal TAP block for PDC implantation. TRIAL REGISTRATION TCTR20160911002 . Registered on 8 September 2016.",2021,"Visual analogue scale (VAS) at most time points (except for the catheter exit site) were lower in group TAP, compared with group TPVB.","['peritoneal dialysis catheter implantation', 'Eighty-eight eligible patients were enrolled', 'Patients undergoing PDC implantations']","['transversus abdominis plane (TAP) block', 'single-injection US-TPVB', 'single-injection ultrasound-guided thoracic paravertebral block (US-TPVB', 'ropivacaine', 'TPVB or TAP or LAI', 'single-injection ultrasound-guided thoracic paravertebral block with transversus abdominis plane block']","['general anesthesia conversion rate, cumulative rescuing sufentanil consumption, and satisfaction rate', 'quality and reliability of anesthesia', 'satisfaction rates', 'VAS at parietal peritoneum manipulation', 'Visual analogue scale (VAS', 'pain relief', 'Anesthesia quality']","[{'cui': 'C0179783', 'cui_str': 'Peritoneal dialysis catheter'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0198813', 'cui_str': 'Local anesthesia, by infiltration'}]","[{'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0230203', 'cui_str': 'Parietal peritoneum structure'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",88.0,0.559527,"Visual analogue scale (VAS) at most time points (except for the catheter exit site) were lower in group TAP, compared with group TPVB.","[{'ForeName': 'Xiao-Juan', 'Initials': 'XJ', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu, 610041, Sichuan, China.'}, {'ForeName': 'Zi', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Nephrology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu, 610041, Sichuan, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu, 610041, Sichuan, China. liqimd@qq.com.'}, {'ForeName': 'Hai-Yan', 'Initials': 'HY', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu, 610041, Sichuan, China.'}, {'ForeName': 'Xiao-Hong', 'Initials': 'XH', 'LastName': 'Tang', 'Affiliation': 'Department of Nephrology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu, 610041, Sichuan, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu, 610041, Sichuan, China.'}]",Trials,['10.1186/s13063-021-05223-7'] 3362,33836810,"Evaluation of the online-based self-help programme ""Selfapy"" in patients with unipolar depression: study protocol for a randomized, blinded parallel group dismantling study.","BACKGROUND Patients with mild to moderate depressive symptoms can have limited access to regular treatment; to ensure appropriate care, low-threshold treatment is needed. Effective online interventions could increase the supply of low-threshold treatment. Further research is needed to evaluate the effectiveness of online interventions. This study aims to evaluate the online-based self-help programme ""Selfapy"" on a sample of depressive subjects and compares the impact of the programme's unaccompanied version with its therapeutic accompanied version. METHODS A sample of 400 subjects that have a mild to severe depressive episode (Becks Depression Inventory - II and Hamilton Depression Scale) will be used. Subjects are randomly assigned to immediate access to an unaccompanied course (no support from psychologist via weekly phone calls), immediate access to an accompanied course (support from a psychologist via weekly phone calls) or a waiting list control group (access to the intervention after 24 weeks). The intervention will last for a period of 12 weeks. Depressive symptoms as a primary parameter, as well as various secondary parameters, such as life satisfaction, therapeutic relationships, social activation, self-esteem, attitudes towards Internet interventions and drop-out rates, are recorded at four different points in time: at baseline (T1), 6 weeks after the start of the intervention (T2), 12 weeks after the start of the intervention (T3) and 3 months after completion of the treatment follow-up (T4). CONCLUSION This randomized and controlled, blinded study will make use of a ""dismantled"" approach to adequately compare the accompanied and unaccompanied versions of the intervention. Positive and meaningful results are expected that could influence the acceptance and implementation of online interventions. TRIAL REGISTRATION German Clinical Trials Register DRKS00017191. Registered on 14 June 2019.",2021,"This study aims to evaluate the online-based self-help programme ""Selfapy"" on a sample of depressive subjects and compares the impact of the programme's unaccompanied version with its therapeutic accompanied version. ","['patients with unipolar depression', 'Patients with mild to moderate depressive symptoms', '400 subjects that have a mild to severe depressive episode (Becks Depression Inventory - II and Hamilton Depression Scale']","['unaccompanied course (no support from psychologist via weekly phone calls), immediate access to an accompanied course (support from a psychologist via weekly phone calls) or a waiting list control group (access to the intervention', 'online-based self-help programme ""Selfapy']","['Depressive symptoms', 'life satisfaction, therapeutic relationships, social activation, self-esteem, attitudes towards Internet interventions and drop-out rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode, unspecified'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}]",400.0,0.0464612,"This study aims to evaluate the online-based self-help programme ""Selfapy"" on a sample of depressive subjects and compares the impact of the programme's unaccompanied version with its therapeutic accompanied version. ","[{'ForeName': 'Rico', 'Initials': 'R', 'LastName': 'Krämer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin Berlin, Campus Mitte, Charitéplatz 1, 10117, Berlin, Germany. rico.kraemer@charite.de.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Köhler', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin Berlin, Campus Mitte, Charitéplatz 1, 10117, Berlin, Germany.'}]",Trials,['10.1186/s13063-021-05218-4'] 3363,33836807,Effectiveness of Yijinjing on cognitive functions in post-stroke patients with mild cognitive impairment: study protocol for a randomized controlled trial.,"BACKGROUND Statistics show that every year, 5.4 million people in the world suffer a stroke. Post-stroke cognitive impairment (PSCI) is one of the most common complications after stroke with a rate of 75%, which leads to decreased functions for independent living and reduced quality of life (QOL). Exercise training has been reported to be useful to improve the cognitive functions of post-stroke patients. Yijinjing, a traditional Chinese Qigong exercise characterized by an integration of mind and body in moderate exercise intensity, can improve cognitive functions of PSCI patients. This study aims to explore the feasibility and effectiveness of the Yijinjing exercise in this regard. METHODS A single-blind, superiority, randomized controlled trial will be employed with evaluations at 3 and 6 months. Seventy-two PSCI patients will be recruited and randomly assigned to the Yijinjing exercise intervention group or the control group (1:1). Participants in the control group will receive routine rehabilitation therapies, including occupational therapy, physical therapy, acupuncture therapy, and health education 5 times a week for 3 months. The intervention group will receive a 12-week routine rehabilitation therapy combined with the Yijinjing exercise intervention for 40 min each session and 3 sessions a week. The primary outcome of cognition will be measured by the Montreal Cognitive Assessment scale (MoCA). Secondary outcomes include executive function, memory function, visuospatial function, sleep quality, gait and motor function, activity of daily living (ADL), and quality of life (QOL). DISCUSSION Current evidence has reported the effectiveness of traditional Chinese exercise in improving the post-stroke population's motor functions. This research is a randomized controlled trial that evaluates traditional Chinese exercise's effectiveness for PSCI patients. It is expected to expand the traditional Chinese exercise scope and provide a new treatment approach for stroke populations with cognitive impairments. TRIAL REGISTRATION Chinese Clinical Trial Registry ChiCTR1900026532 . Registered on 13 October 2019.",2021,"Participants in the control group will receive routine rehabilitation therapies, including occupational therapy, physical therapy, acupuncture therapy, and health education 5 times a week for 3 months.","['post-stroke patients with mild cognitive impairment', 'Seventy-two PSCI patients', 'stroke populations with cognitive impairments', 'PSCI patients']","['traditional Chinese exercise', 'routine rehabilitation therapies, including occupational therapy, physical therapy, acupuncture therapy, and health education', 'Yijinjing exercise', 'Yijinjing exercise intervention', 'Exercise training', 'routine rehabilitation therapy combined with the Yijinjing exercise intervention']","['cognition will be measured by the Montreal Cognitive Assessment scale (MoCA', 'cognitive functions', 'quality of life (QOL', 'executive function, memory function, visuospatial function, sleep quality, gait and motor function, activity of daily living (ADL), and quality of life (QOL']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",72.0,0.03383,"Participants in the control group will receive routine rehabilitation therapies, including occupational therapy, physical therapy, acupuncture therapy, and health education 5 times a week for 3 months.","[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Xue', 'Affiliation': 'School of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine, No. 1200, Cai-Lun Road, Shanghai, China.'}, {'ForeName': 'Xue-Ming', 'Initials': 'XM', 'LastName': 'Jin', 'Affiliation': 'School of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine, No. 1200, Cai-Lun Road, Shanghai, China.'}, {'ForeName': 'Kai-Liang', 'Initials': 'KL', 'LastName': 'Luo', 'Affiliation': 'School of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine, No. 1200, Cai-Lun Road, Shanghai, China.'}, {'ForeName': 'Xin-Hao', 'Initials': 'XH', 'LastName': 'Liu', 'Affiliation': 'School of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine, No. 1200, Cai-Lun Road, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'School of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine, No. 1200, Cai-Lun Road, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'School of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine, No. 1200, Cai-Lun Road, Shanghai, China. jasonhwu@126.com.'}]",Trials,['10.1186/s13063-021-05220-w'] 3364,33836740,Potential of different fluoride gels to prevent erosive tooth wear caused by gastroesophageal reflux.,"BACKGROUND This in-vitro-study aimed to evaluate the potential of different fluoride gels to prevent gastroesophageal reflux induced erosive tooth wear. METHODS Surface baseline profiles of a total of 50 bovine enamel specimens [randomly assigned to five groups (G1-5)] were recorded. All specimens were positioned in a custom made artificial oral cavity and perfused with artificial saliva (0.5 ml/min). Reflux was simulated 11 times a day during 12 h by adding HCl (pH 3.0) for 30 s (flow rate 2 ml/min). During the remaining 12 h (overnight), specimens were stored in artificial saliva and brushed twice a day (morning and evening) with a toothbrush and toothpaste slurry (15 brushing strokes). While specimens in the control group (G1) did not receive any further treatment, specimens in G2-5 were coated with different fluoride gels [Elmex Gelée (G2); Paro Amin Fluor Gelée (G3); Paro Fluor Gelée Natriumfluorid (G4); Sensodyne ProSchmelz Fluorid Gelée (G5)] in the evening for 30 s. After 20 days, surface profiles were recorded again and enamel loss was determined by comparing them with the baseline profiles. The results were statistically analysed using one-way analysis of variance (ANOVA) followed by Tukey`s HSD post-hoc test. RESULTS The overall highest mean wear of enamel (9.88 ± 1.73 µm) was observed in the control group (G1), where no fluoride gel was applied. It was significantly higher (p < 0.001) compared to all other groups. G2 (5.03 ± 1.43 µm), G3 (5.47 ± 0.63 µm, p = 0.918) and G4 (5.14 ± 0.82 µm, p > 0.999) showed the overall best protection from hydrochloric acid induced erosion. Enamel wear in G5 (6.64 ± 0.86 µm) was significantly higher compared to G2 (p = 0.028) and G4 (p = 0.047). CONCLUSIONS After 20 days of daily application, all investigated fluoride gels are able to significantly reduce gastroesophageal reflux induced loss of enamel.",2021,"After 20 days of daily application, all investigated fluoride gels are able to significantly reduce gastroesophageal reflux induced loss of enamel.","['30\xa0s', 'Surface baseline profiles of a total of 50 bovine enamel specimens']","['fluoride gels [Elmex Gelée (G2); Paro Amin Fluor Gelée (G3); Paro Fluor Gelée Natriumfluorid (G4); Sensodyne ProSchmelz', 'toothbrush and toothpaste slurry']","['Fluorid Gelée (G5', 'gastroesophageal reflux induced loss of enamel', 'enamel loss', 'Reflux', 'gastroesophageal reflux']","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C3881208', 'cui_str': 'Fluoride gel'}, {'cui': 'C0059034', 'cui_str': 'Elmex'}, {'cui': 'C0385317', 'cui_str': 'Sensodyne'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}]","[{'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}]",50.0,0.0587879,"After 20 days of daily application, all investigated fluoride gels are able to significantly reduce gastroesophageal reflux induced loss of enamel.","[{'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Körner', 'Affiliation': 'Clinic of Conservative and Preventive Dentistry, Center of Dental Medicine, University of Zurich, Plattenstrasse 11, 8032, Zurich, Switzerland. philipp.koerner@zzm.uzh.ch.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Georgis', 'Affiliation': 'Clinic of Conservative and Preventive Dentistry, Center of Dental Medicine, University of Zurich, Plattenstrasse 11, 8032, Zurich, Switzerland.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Wiedemeier', 'Affiliation': 'Statistical Services, Center of Dental Medicine, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Attin', 'Affiliation': 'Clinic of Conservative and Preventive Dentistry, Center of Dental Medicine, University of Zurich, Plattenstrasse 11, 8032, Zurich, Switzerland.'}, {'ForeName': 'Florian J', 'Initials': 'FJ', 'LastName': 'Wegehaupt', 'Affiliation': 'Clinic of Conservative and Preventive Dentistry, Center of Dental Medicine, University of Zurich, Plattenstrasse 11, 8032, Zurich, Switzerland.'}]",BMC oral health,['10.1186/s12903-021-01548-6'] 3365,33842322,Comprehensive Comparison Between Adjuvant Targeted Therapy and Chemotherapy for EGFR-Mutant NSCLC Patients: A Cost-Effectiveness Analysis.,"Background Chemotherapy has been the current standard adjuvant treatment for early-stage non-small-cell lung cancer (NSCLC) patients, while recent studies showed benefits of epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). We conducted a cost-effectiveness analysis to comprehensively evaluate the benefit of EGFR-TKI compared with chemotherapy for early-stage EGFR-mutant NSCLC patients after resection from the perspective of the Chinese health care system. Method A Markov model was established. Clinical data were based on the phase 3, ADJUVANT trial, where stage II-IIIA, EGFR-mutant NSCLC patients were randomized into gefitinib group or chemotherapy group after resection. Cost parameters mainly included costs of drugs, examinations, and adverse events (AEs). Effect parameters were evaluated by quality-adjusted life year (QALY). Outcomes contained incremental cost-effective ratio (ICER), average cost-effective ratio (ACER), and net benefit. The willingness-to-pay threshold was set as 3 times per capita gross domestic product ($30,828/QALY). Sensitivity analyses were also conducted to verify the stability of the model. Results Patients who received gefitinib had both a higher cost ($12,057.98 vs. $11,883.73) and a higher QALY (1.55 vs. 1.42) than patients who received chemotherapy. With an ICER of $1,345.62/QALY, adjuvant gefitinib was of economic benefit compared with chemotherapy. The ACER and net benefit were also consistent (gefitinib vs. chemotherapy, ACER: $7,802.30/QALY vs. $8,392.77/QALY; net benefit: $35,584.85 vs. $31,767.17). Sensitivity analyses indicated the stability of the model and the impact of utility. Conclusion Adjuvant EGFR-TKI application for early-stage EGFR-mutant NSCLC patients was cost-effective compared with chemotherapy, which might provide a reference for clinical decision-making and medical insurance policy formulation in China.",2021,"With an ICER of $1,345.62/QALY, adjuvant gefitinib was of economic benefit compared with chemotherapy.","['EGFR-Mutant NSCLC Patients', 'early-stage EGFR-mutant NSCLC patients', 'early-stage EGFR-mutant NSCLC patients after resection from the perspective of the Chinese health care system', 'early-stage non-small-cell lung cancer (NSCLC) patients']","['\n\n\nChemotherapy', 'gefitinib group or chemotherapy', 'chemotherapy', 'gefitinib vs. chemotherapy, ACER']","['quality-adjusted life year (QALY', 'costs of drugs, examinations, and adverse events (AEs', 'incremental cost-effective ratio (ICER), average cost-effective ratio (ACER), and net benefit']","[{'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}]",,0.101644,"With an ICER of $1,345.62/QALY, adjuvant gefitinib was of economic benefit compared with chemotherapy.","[{'ForeName': 'Wenqian', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Cancer Center, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Hanfei', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': 'Cancer Center, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Lingyu', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Cancer Center, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Jiuwei', 'Initials': 'J', 'LastName': 'Cui', 'Affiliation': 'Cancer Center, The First Hospital of Jilin University, Changchun, China.'}]",Frontiers in oncology,['10.3389/fonc.2021.619376'] 3366,33842288,Carboxymethyl Cellulose versus Hydroxypropyl Methylcellulose Tear Substitutes for Dry Eye Due to Computer Vision Syndrome: Comparison of Efficacy and Safety.,"Background Prolonged use of visual display terminal images on electronic devices such as computers frequently leads to symptoms of dry eye. Tear substitutes form the mainstay of treatment for mild-to-moderate dry eye. Aim The study aimed to evaluate the efficacy and safety of carboxymethyl cellulose (CMC) versus hydroxypropyl methylcellulose (HPMC) tear substitutes for dry eye due to computer vision syndrome (CVS). Materials and Methods This was a prospective, randomized, comparative, and open-labeled study. The efficacy of CMC 0.5% and HPMC 0.3% tear substitutes was compared in 180 participants (90 in each group) with dry eye. Change in Ocular Surface Disease Index (OSDI) score, Schirmer I test score, and tear film break up time (TF-BUT) were used as efficacy parameters. Safety was monitored on all visits. Results The baseline OSDI score? 23.48 and 23.32 in Group A and B, respectively, decreased with treatment in both groups on all follow-up visits as compared to the baseline (day 90: 13.9 ± 3 vs. 14.81 ± 3.17, P : 0.01). The scores of Schirmer I test increased in both groups, with a greater improvement in Group A (at day 90: 22.75 ± 3.04 mm vs. 21.78 ± 3.36 mm, P : 0.04). The values of TF-BUT improved in both groups, the difference being statistically insignificant. An initial stinging was reported by one participant, each in both groups. Conclusion CMC and HPMC tear substitutes were equally efficacious and safe in reducing symptoms of dry eye due to CVS.",2021,"The scores of Schirmer I test increased in both groups, with a greater improvement in Group A (at day 90: 22.75 ± 3.04 mm vs. 21.78 ± 3.36 mm, P : 0.04).","['mild-to-moderate dry eye', 'dry eye due to computer vision syndrome (CVS', 'Computer Vision Syndrome', '180 participants (90 in each group) with dry eye']","['carboxymethyl cellulose (CMC', 'hydroxypropyl methylcellulose (HPMC) tear substitutes', 'Carboxymethyl Cellulose versus Hydroxypropyl Methylcellulose Tear Substitutes for Dry Eye', 'CMC']","['Efficacy and Safety', 'scores of Schirmer I test', 'efficacy and safety', 'Safety', 'baseline OSDI score', 'values of TF-BUT', 'Change in Ocular Surface Disease Index (OSDI) score, Schirmer']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C2609092', 'cui_str': 'Computer vision syndrome'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0007068', 'cui_str': 'Carboxymethylcellulose'}, {'cui': 'C0063242', 'cui_str': 'hypromellose'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1301514', 'cui_str': 'Schirmer I test'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0429495', 'cui_str': 'Tear film break-up time'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",180.0,0.0199286,"The scores of Schirmer I test increased in both groups, with a greater improvement in Group A (at day 90: 22.75 ± 3.04 mm vs. 21.78 ± 3.36 mm, P : 0.04).","[{'ForeName': 'Rahul M', 'Initials': 'RM', 'LastName': 'Rajendraprasad', 'Affiliation': 'Medical Advisor, Novo Nordisk India, Bengaluru, Karnataka, India.'}, {'ForeName': 'Gagandeep', 'Initials': 'G', 'LastName': 'Kwatra', 'Affiliation': 'Department of Pharmacology, Christian Medical College and Hospital, Ludhiana, Punjab, India.'}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Batra', 'Affiliation': 'Department of Ophthalmology, Christian Medical College and Hospital, Ludhiana, Punjab, India.'}]",International journal of applied & basic medical research,['10.4103/ijabmr.IJABMR_399_20'] 3367,33842252,"Effects of laparoscopic and traditional open surgery on the levels of IL-6, TNF-α, and Gal-3 in patients with thyroid cancer.","Background Traditional open surgery and laparoscopic surgery are common treatments for thyroid cancer patients, this paper aims to explore their effects on the levels of interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), and galectin-3 (Gal-3) in patients with thyroid cancer. Methods The clinical data of patients with thyroid cancer who received surgery in our hospital from September 2017 to February 2020 were collected. In total, 106 cases that met the inclusion and exclusion criteria were included. The patients were then allocated into two groups according to the surgery received, including a study group (56 cases treated with endoscopy) and a basic group (50 cases treated with traditional open surgery). Rehabilitation indicators and inflammatory cytokines were compared between the two groups. Results There was no significant difference in the number of intraoperative lymph node dissections (P>0.05), postoperative complication rate (16.08% vs. 20.00%, P>0.05), and 6-month rate of recurrence or metastasis (P>0.05) between the two groups. Compared to the basic group, the operation time of the study group was longer, while the amount of intraoperative blood loss, 24 h drainage of the catheter and the length of hospital stay were significantly lower in the study group (P<0.05). The pain scores of the study group at 24 and 48 h after surgery were significantly lower than those of the basic group (P<0.05). The levels of IL-6, TNF-α, Gal-3, and other inflammatory factors in the two groups increased on the first day postoperatively, however the levels of these factors in the study group were lower than those in the basic group (P<0.05). Finally, the postoperative cosmetic satisfaction rate of the study group (94.64%) was higher than that of the basic group (86.00%), and the difference was statistically significant (P<0.05). Conclusions The use of laparoscopic treatment can reduce the amount of intraoperative blood loss in patients with thyroid cancer, effectively reduce the degree of postoperative pain, and inhibit postoperative inflammation in the patient to a certain extent. Moreover, laparoscopic treatment can increase postoperative cosmetic satisfaction, reduce the occurrence of postoperative complications and recurrence rate, and improve the patient's prognosis.",2021,"There was no significant difference in the number of intraoperative lymph node dissections (P>0.05), postoperative complication rate (16.08% vs. 20.00%, P>0.05), and 6-month rate of recurrence or metastasis (P>0.05) between the two groups.","['patients with thyroid cancer who received surgery in our hospital from September 2017 to February 2020 were collected', 'thyroid cancer patients', 'patients with thyroid cancer', '106 cases that met the inclusion and exclusion criteria were included']","['laparoscopic treatment', '\n\n\nTraditional open surgery and laparoscopic surgery', 'endoscopy', 'laparoscopic and traditional open surgery', 'traditional open surgery']","['postoperative complication rate', 'postoperative cosmetic satisfaction rate', 'postoperative cosmetic satisfaction', 'intraoperative blood loss, 24 h drainage of the catheter and the length of hospital stay', 'levels of IL-6, TNF-α, and Gal-3', 'operation time', 'pain scores', 'levels of IL-6, TNF-α, Gal-3, and other inflammatory factors', 'Rehabilitation indicators and inflammatory cytokines', 'occurrence of postoperative complications and recurrence rate', 'levels of interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), and galectin-3 (Gal-3', '6-month rate of recurrence or metastasis', 'number of intraoperative lymph node dissections', 'intraoperative blood loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007115', 'cui_str': 'Malignant tumor of thyroid gland'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0245382', 'cui_str': 'Galectin-3'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}]",,0.129883,"There was no significant difference in the number of intraoperative lymph node dissections (P>0.05), postoperative complication rate (16.08% vs. 20.00%, P>0.05), and 6-month rate of recurrence or metastasis (P>0.05) between the two groups.","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'He', 'Affiliation': ""Department of Thyroid and Breast Surgery, Sichuan Provincial People's Hospital (East Hospital), University of Electronic Science and Technology of China, Chengdu, China.""}, {'ForeName': 'Fangzhen', 'Initials': 'F', 'LastName': 'Qing', 'Affiliation': 'Chinese Academy of Sciences Sichuan Translational Medicine Research Hospital, Chengdu, China.'}, {'ForeName': 'Maode', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Chinese Academy of Sciences Sichuan Translational Medicine Research Hospital, Chengdu, China.'}, {'ForeName': 'Daitian', 'Initials': 'D', 'LastName': 'Lan', 'Affiliation': 'Chinese Academy of Sciences Sichuan Translational Medicine Research Hospital, Chengdu, China.'}]",Gland surgery,['10.21037/gs-21-60'] 3368,33842041,A Preseason Training Program With the Nordic Hamstring Exercise Increases Eccentric Knee Flexor Strength and Fascicle Length in Professional Female Soccer Players.,"Background Training programs that include the Nordic hamstring exercise (NHE) have been shown to increase eccentric knee flexor strength and biceps femoris fascicle length in male athletes. However, the effect of NHE on female athletes remains unknown. Purpose To investigate the collective and individual responses of professional female soccer players engaged in a preseason training program with the NHE regarding eccentric knee flexor strength and biceps femoris long head fascicle length. Study Design Quasi-experimental study. Methods Sixteen amateur female soccer players (without a NHE training routine) were evaluated 8-weeks apart to: (1) assess reliability of eccentric knee flexor strength and biceps femoris fascicle length measures; and (2) determine the typical error of measures that would be used to discriminate training responders and non-responders. The NHE training group had 17 professional female soccer players who performed an 8-week training program with the NHE during preseason. Within-group analysis was performed with paired sample t-tests (pre- vs. post-training), and individual responses were determined using the typical error criteria. Results The non-trained group's data demonstrated that measures of strength (ICC=0.82-0.87, typical error = 12-13 N) and fascicle length (ICC=0.92-0.97; typical error = 0.19-0.38 cm) were reliable. In the NHE training group, both limbs increased the eccentric knee flexor strength (~13%; ES=0.74-0.82) and the biceps femoris fascicle length (~6%; ES=0.44-0.65). Twelve players (~71%) were considered responders to the NHE training program for the eccentric knee flexor strength, while eight athletes (~47%) were responders for the biceps femoris fascicle length. Conclusion The 8-week preseason training program with the NHE increased both eccentric knee flexor strength and biceps femoris fascicle length in professional female soccer players. More than two-thirds of players demonstrated a meaningful increase in eccentric strength, while nearly half achieved consistent fascicle length increases with the NHE training.",2021,"In the NHE training group, both limbs increased the eccentric knee flexor strength (~13%; ES=0.74-0.82) and the biceps femoris fascicle length (~6%; ES=0.44-0.65).","['Sixteen amateur female soccer players (without a NHE training routine', 'Professional Female Soccer Players', 'group had 17 professional female soccer players who performed an 8-week training program with the NHE during preseason', 'professional female soccer players', 'male athletes']","['NHE training program', 'NHE', 'Preseason Training Program', 'NHE training', 'Nordic hamstring exercise (NHE', 'Nordic Hamstring Exercise', 'preseason training program with the NHE increased both eccentric knee flexor strength and biceps femoris fascicle length']","['eccentric strength', 'biceps femoris fascicle length', 'fascicle length', 'Eccentric Knee Flexor Strength and Fascicle Length', 'eccentric knee flexor strength', 'eccentric knee flexor strength and biceps femoris fascicle length']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0224449', 'cui_str': 'Biceps femoris muscle structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}]","[{'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0224449', 'cui_str': 'Biceps femoris muscle structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]",17.0,0.00888475,"In the NHE training group, both limbs increased the eccentric knee flexor strength (~13%; ES=0.74-0.82) and the biceps femoris fascicle length (~6%; ES=0.44-0.65).","[{'ForeName': 'Karoline Baptista', 'Initials': 'KB', 'LastName': 'Vianna', 'Affiliation': 'Universidade Federal de Ciências da Saúde de Porto Alegre.'}, {'ForeName': 'Lívia Gonçalves', 'Initials': 'LG', 'LastName': 'Rodrigues', 'Affiliation': 'Universidade Federal de Ciências da Saúde de Porto Alegre.'}, {'ForeName': 'Nathalia Trevisol', 'Initials': 'NT', 'LastName': 'Oliveira', 'Affiliation': 'Universidade Federal de Ciências da Saúde de Porto Alegre.'}, {'ForeName': 'João Breno', 'Initials': 'JB', 'LastName': 'Ribeiro-Alvares', 'Affiliation': 'Universidade Federal de Ciências da Saúde de Porto Alegre.'}, {'ForeName': 'Bruno Manfredini', 'Initials': 'BM', 'LastName': 'Baroni', 'Affiliation': 'Universidade Federal de Ciências da Saúde de Porto Alegre.'}]",International journal of sports physical therapy,['10.26603/001c.19452'] 3369,33842037,Acute Effects of Dry Needling on Myofascial Trigger Points in the Triceps Surae of Ballet Dancers: A Pilot Randomized Controlled Trial.,"Background There is convincing evidence that dancers suffer injuries to the triceps surae musculature. Research on the immediate effects of dry needling (DN) is limited, and it is important to understand the acute effects of this treatment prior to performance. Purpose The purpose of this pilot study was to assess the immediate effects of DN on myofascial trigger points in terms of skin surface temperature, pain, active and passive range of motion, and torque production in the triceps surae of ballet dancers. Study Design Randomized, double-blinded pilot study. Methods Professional ballet dancers that fit inclusion and exclusion criteria (n=11) were randomly assigned to an experimental or control group. The dancers had three pre-determined standard point (SP) measurement spots that were used as a baseline for surface temperature comparisons. The dancers were also palpated for trigger point (TP) spots. Both SP and TP spots were marked for future measurements. The experimental group received DN, while the control group received sham DN (SHAM) to their bilateral calves at the TP spots. Immediately prior to and following treatment, both DN and SHAM groups were tested for skin surface temperature, pain, range of motion, and plantar flexion torque by blinded assessors. Paired t-tests and independent t-tests were performed to examine for differences between groups. Results The surface temperature for the TP was higher than the SP measurements prior to intervention (Right calf p= .014; Left calf p= .031). There were no significant changes in VAS scale reported pain and ROM. The plantar flexion torque measurements showed an increase in the DN group of the left calf at the angular velocity of 60 degrees/sec. Conclusion This was a unique pilot study examining the acute effects of DN on professional ballet dancers. The results were limited due to low sample size. However, the methodology for this study and surface temperature results invites future research. Level of evidence Level 1b.",2021,The surface temperature for the TP was higher than the SP measurements prior to intervention (Right calf p= .014;,"['Methods\n\n\nProfessional ballet dancers that fit inclusion and exclusion criteria (n=11', 'Triceps Surae of Ballet Dancers']","['Dry Needling', 'DN, while the control group received sham DN (SHAM', 'dry needling (DN']","['VAS scale reported pain and ROM', 'surface temperature for the TP', 'skin surface temperature, pain, range of motion, and plantar flexion torque', 'Myofascial Trigger Points', 'plantar flexion torque measurements', 'skin surface temperature, pain, active and passive range of motion, and torque production']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0871967', 'cui_str': 'Ballet'}, {'cui': 'C0335081', 'cui_str': 'Dancer'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0231784', 'cui_str': 'Plantar flexion'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}]",,0.16769,The surface temperature for the TP was higher than the SP measurements prior to intervention (Right calf p= .014;,"[{'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Janowski', 'Affiliation': 'Andrews University.'}, {'ForeName': 'Deanna M L', 'Initials': 'DML', 'LastName': 'Phelan-Smith', 'Affiliation': 'Northwestern University.'}, {'ForeName': 'Maria N', 'Initials': 'MN', 'LastName': 'Kroat Brady', 'Affiliation': 'Northwestern University.'}, {'ForeName': 'Kelsey L', 'Initials': 'KL', 'LastName': 'Michels', 'Affiliation': 'Northwestern University.'}, {'ForeName': 'Alexandra H', 'Initials': 'AH', 'LastName': 'Timm', 'Affiliation': 'Northwestern University.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Boucher', 'Affiliation': 'Northwestern University.'}, {'ForeName': 'Kedron D', 'Initials': 'KD', 'LastName': 'Casteen', 'Affiliation': 'Northwestern University.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Village', 'Affiliation': 'Andrews University.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Sleeper', 'Affiliation': 'Northwestern University.'}]",International journal of sports physical therapy,['10.26603/001c.21475'] 3370,33842027,Reliability of the Cutting Alignment Scoring Tool (CAST) to Assess Trunk and Limb Alignment During a 45-Degree Side-Step Cut.,"Background Three-dimensional (3D) motion analysis is considered the gold standard for evaluating human movement. However, its clinical utility is limited due to cost, operating expertise, and lengthy data processing time. Numerous qualitative scoring systems have been introduced to assess trunk and lower extremity biomechanics during functional tasks. However, the reliability of qualitative scoring systems to evaluate cutting movements is understudied. Purpose/Hypotheses: To assess the inter-rater and intra-rater reliability of the Cutting Alignment Scoring Tool (CAST) among sports medicine providers and to evaluate rater agreement of each component of the CAST. The hypotheses were: 1) there would be good-to-excellent inter-rater and intra-rater reliability among sports medicine providers, 2) there would be good to almost perfect agreement for cut width and trunk lean variables and moderate to good agreement for valgus variables of the CAST. Study Design Repeated Measures. Methods Ten videos of a 45-degree side-step cut performed by adolescent athletes were independently rated on two occasions by six raters (2 medical doctors, 2 physical therapists, and 2 athletic trainers). The variables assessed include trunk lean to the opposite direction of the cut, increased cut width, knee valgus at initial load acceptance (static), and knee valgus throughout the task (dynamic). Variables were scored as either present, which were given a score of ""1"", or not present, which were given a score of ""0"". Video sequence was randomized in each rating session, and a two-week wash out period was given. Results The cumulative inter-rater and intra-rater reliabilities were good (ICC: 0.808 and ICC: 0.753). Almost perfect kappa coefficients were recorded for cut width (k=0.949). Moderate kappa coefficients were found for trunk lean (k= 0.632) and fair kappa coefficients were noted for dynamic and static valgus (k=0.462 and k= 0.533 respectively). Conclusion These findings suggest that the CAST is a reliable tool to evaluate trunk and LE alignment during a cutting task by sports medicine providers. Level of Evidence Level 2 Diagnosis.",2021,The cumulative inter-rater and intra-rater reliabilities were good,"['adolescent athletes were independently rated on two occasions by six raters (2 medical doctors, 2 physical therapists, and 2 athletic trainers']","['Cutting Alignment Scoring Tool (CAST', 'CAST']","['trunk lean to the opposite direction of the cut, increased cut width, knee valgus at initial load acceptance (static), and knee valgus throughout the task (dynamic', 'fair kappa coefficients', 'Moderate kappa coefficients', 'cumulative inter-rater and intra-rater reliabilities']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}]","[{'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0179686', 'cui_str': 'Cast'}]","[{'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0042282', 'cui_str': 'Valgus deformity'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C2911689', 'cui_str': 'Fair'}, {'cui': 'C0439099', 'cui_str': 'Kappa'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}]",2.0,0.0456072,The cumulative inter-rater and intra-rater reliabilities were good,"[{'ForeName': 'Lauren S', 'Initials': 'LS', 'LastName': 'Butler', 'Affiliation': ""Nicklaus Children's Hospital.""}, {'ForeName': 'Eryn K', 'Initials': 'EK', 'LastName': 'Milian', 'Affiliation': 'University of Miami.'}, {'ForeName': 'Amie', 'Initials': 'A', 'LastName': 'DeVerna', 'Affiliation': ""Nicklaus Children's Hospital.""}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Latz', 'Affiliation': ""Children's Mercy Hospital.""}, {'ForeName': 'Henry B', 'Initials': 'HB', 'LastName': 'Ellis', 'Affiliation': 'Scottish Rite Hospital; University of Texas Southwestern Medical Center.'}, {'ForeName': 'Alexa R', 'Initials': 'AR', 'LastName': 'Martinez', 'Affiliation': ""Nicklaus Children's Hospital.""}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Hayden', 'Affiliation': ""Nicklaus Children's Hospital.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gerstenkorn', 'Affiliation': ""Nicklaus Children's Hospital.""}, {'ForeName': 'Sara C', 'Initials': 'SC', 'LastName': 'Carpenito', 'Affiliation': ""Boston Children's Hospital; The Micheli Center for Sports Injury Prevention.""}, {'ForeName': 'Charles W', 'Initials': 'CW', 'LastName': 'Wyatt', 'Affiliation': 'Scottish Rite Hospital; University of Texas Southwestern Medical Center.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Sugimoto', 'Affiliation': 'The Micheli Center for Sports Injury Prevention; Waseda University.'}]",International journal of sports physical therapy,['10.26603/001c.21419'] 3371,33842006,Comparison of tear proteomic and neuromediator profiles changes between small incision lenticule extraction (SMILE) and femtosecond laser-assisted in-situ keratomileusis (LASIK).,"Introduction The tear proteomics and neuromediators are associated with clinical dry eye parameters following refractive surgery. Purpose To investigate and compare the tear proteomic and neuromediator profiles following small incision lenticule extraction (SMILE) versus laser-assisted in-situ keratomileusis (LASIK). Methods In this randomized controlled trial with paired-eye design, 70 patients were randomized to receive SMILE in one eye and LASIK in the other eye. Tear samples were collected preoperatively, and 1 week, 1, 3, 6 and 12 months postoperatively, and were examined for protein concentration changes using sequential window acquisition of all theoretical fragment ion mass spectrometry (SWATH-MS). The data were analyzed with DAVID Bioinformatics Resources for enriched gene ontology terms and over-represented pathways. Tear neuromediators levels were correlated with clinical parameters. Results Post-SMILE eyes had significantly better Oxford staining scores and tear break-up time (TBUT) than post-LASIK eyes at 1 and 3 months, respectively. Tear substance P and nerve growth factor levels were significantly higher in the LASIK group for 3 months and 1 year, respectively. SMILE and LASIK shared some similar biological responses postoperatively, but there was significant up-regulation in leukocyte migration and wound healing at 1 week, humoral immune response and apoptosis at 1 month, negative regulation of endopeptidase activity at 3 to 6 months, and extracellular structure organization at 1 year in the post-LASIK eyes. Tear mucin-like protein 1 and substance P levels were significantly correlated with TBUT ( r  = -0.47, r  = -0.49, respectively). Conclusion Significant differences in the tear neuromediators and proteomics were observed between SMILE and LASIK, even though clinical dry eye signs have subsided and became comparable between 2 procedures.",2021,"Tear substance P and nerve growth factor levels were significantly higher in the LASIK group for 3 months and 1 year, respectively.",['70 patients'],"['small incision lenticule extraction (SMILE) and femtosecond laser-assisted', 'small incision lenticule extraction (SMILE) versus laser-assisted', 'LASIK', 'SMILE in one eye and LASIK', 'TBUT ']","['leukocyte migration and wound healing', 'Oxford staining scores and tear break-up time (TBUT', 'Tear substance P and nerve growth factor levels', 'Tear neuromediators levels', 'Tear mucin-like protein 1 and substance P levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0752094', 'cui_str': 'Laser assisted in situ keratomileusis'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038585', 'cui_str': 'Substance P'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1335977', 'cui_str': 'SBEM protein, human'}]",70.0,0.0403002,"Tear substance P and nerve growth factor levels were significantly higher in the LASIK group for 3 months and 1 year, respectively.","[{'ForeName': 'Yu-Chi', 'Initials': 'YC', 'LastName': 'Liu', 'Affiliation': 'Tissue Engineering and Cell Therapy Group, Singapore Eye Research Institute, Singapore.'}, {'ForeName': 'Gary Hin-Fai', 'Initials': 'GH', 'LastName': 'Yam', 'Affiliation': 'Tissue Engineering and Cell Therapy Group, Singapore Eye Research Institute, Singapore.'}, {'ForeName': 'Molly Tzu-Yu', 'Initials': 'MT', 'LastName': 'Lin', 'Affiliation': 'Tissue Engineering and Cell Therapy Group, Singapore Eye Research Institute, Singapore.'}, {'ForeName': 'Ericia', 'Initials': 'E', 'LastName': 'Teo', 'Affiliation': 'Tissue Engineering and Cell Therapy Group, Singapore Eye Research Institute, Singapore.'}, {'ForeName': 'Siew-Kwan', 'Initials': 'SK', 'LastName': 'Koh', 'Affiliation': 'Ocular Proteomics, Singapore Eye Research Institute, Singapore.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Deng', 'Affiliation': 'Department of Statistics and Applied Probability, Faculty of Science, National University of Singapore, Singapore.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Ophthalmology and Visual Sciences Academic Clinical Program, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Tong', 'Affiliation': 'Department of Cornea and External Eye Disease, Singapore National Eye Centre, Singapore.'}, {'ForeName': 'Jodhbir S', 'Initials': 'JS', 'LastName': 'Mehta', 'Affiliation': 'Tissue Engineering and Cell Therapy Group, Singapore Eye Research Institute, Singapore.'}]",Journal of advanced research,['10.1016/j.jare.2020.11.001'] 3372,33841960,"Aspirin plus ticagrelor or clopidogrel on graft patency one year after coronary bypass grafting: a single-center, randomized, controlled trial.","Background Dual antiplatelet therapy (DAPT) improves early post-operative graft patency, but the optimal DAPT strategy for the patients after coronary artery bypass grafting (CABG) has not been confirmed. We sought to evaluate the effect of aspirin plus ticagrelor versus aspirin plus clopidogrel on saphenous vein graft (SVG) patency within 1 year after CABG. Methods Between October 2017 and December 2018, 147 consecutive patients undergoing elective CABG at Changhai Hospital were randomized into two groups: group AT, receiving aspirin 100 mg/d plus ticagrelor 2×90 mg/d; group AC, receiving aspirin 100 mg/d plus clopidogrel 75 mg/d. Both DAPTs should be administered within 24 h when clinical stability was ensured. 64-multislice computed tomography angiography (MSCTA) was used to assess the graft patency at 12 months after CABG.CYP2C19 gene variants were measured to assess the clopidogrel efficacy on graft patency. Results Among the 147 participants who completed the study, one (0.7%) patient from the AC group died at 5 weeks after surgery due to severe infection. All other patients were treated with DAPT for 12 months and underwent 64-MSCTA according to schedule. There were no significant differences in pre-operative characteristics and intraoperative transit-time flow measurement findings between the two groups. Besides, no significant differences in the incidence of major adverse cardiac events (MACEs) and major bleeding were observed. A 64-MSCTA showed that SVG patency was 91.0% (141 of 155) in the AT group and 89.9% (161 of 179) in the AC group (P=0.751). No significant associations were found between different CYP2C19 genotypes and SVG patency (P>0.05). Conclusions Either aspirin plus ticagrelor or aspirin plus clopidogrel can maintain a fairly high graft patency rate in the early phase after CABG, regardless of CYP2C19 genotypes.",2021,"Either aspirin plus ticagrelor or aspirin plus clopidogrel can maintain a fairly high graft patency rate in the early phase after CABG, regardless of CYP2C19 genotypes.","['patients after coronary artery bypass grafting (CABG', 'graft patency one year after coronary bypass grafting', '147 participants who completed the study, one (0.7%) patient from the AC group died at 5 weeks after surgery due to severe infection', 'Methods\n\n\nBetween October 2017 and December 2018, 147 consecutive patients undergoing elective CABG at Changhai Hospital']","['64-multislice computed tomography angiography (MSCTA', 'aspirin 100 mg/d plus ticagrelor 2×90 mg/d; group AC, receiving aspirin 100 mg/d plus clopidogrel', 'Aspirin plus ticagrelor or clopidogrel', 'aspirin plus clopidogrel', '\n\n\nDual antiplatelet therapy (DAPT', 'aspirin plus ticagrelor or aspirin plus clopidogrel', 'DAPT', 'aspirin plus ticagrelor']","['CYP2C19 genotypes and SVG patency', 'graft patency', 'graft patency rate', 'SVG patency', 'saphenous vein graft (SVG) patency', 'pre-operative characteristics and intraoperative transit-time flow measurement findings', 'incidence of major adverse cardiac events (MACEs) and major bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C3179130', 'cui_str': 'Multidetector-Row Computed Tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C1124475', 'cui_str': 'Aspirin 100 MG'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0729538', 'cui_str': 'Saphenous vein graft'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1290915', 'cui_str': 'Measurement finding'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",147.0,0.0561376,"Either aspirin plus ticagrelor or aspirin plus clopidogrel can maintain a fairly high graft patency rate in the early phase after CABG, regardless of CYP2C19 genotypes.","[{'ForeName': 'Yangfeng', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Department of Cardiothoracic Surgery, Changhai Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Xinli', 'Initials': 'X', 'LastName': 'Fan', 'Affiliation': 'Department of Cardiothoracic Surgery, Changhai Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Boyao', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiothoracic Surgery, Changhai Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Jiajun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiothoracic Surgery, Changhai Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Xue', 'Affiliation': 'Department of Cardiothoracic Surgery, Changhai Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Zhiyun', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiothoracic Surgery, Changhai Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Han', 'Affiliation': 'Department of Cardiothoracic Surgery, Changhai Hospital, The Second Military Medical University, Shanghai, China.'}]",Journal of thoracic disease,['10.21037/jtd-20-3407'] 3373,33841732,A pilot study to evaluate the effectiveness of adjunctive use of two antimicrobial topical gels in chronic gingivitis.,"Background Gingivitis is one of the most prevalent oral disease in humans. The most important etiological factor of gingivitis is dental plaque. Plaque control procedures comprises of several mechanical and chemical methods. Many studies have advocated that chemical plaque control methods can be used successfully as an adjunct to mechanical plaque control procedures. Thus, the aim of this pilot study is to evaluate the effectiveness of two topical antimicrobial gels as an adjunct to mechanical plaque control over a period of 2 weeks in treatment of chronic gingivitis patients. Material and Methods This is a single blind, two arm parallel design pilot clinical study including 60 systemically healthy patients with 1) chronic generalized gingivitis (MGI>1), 2) probing depth ≤ 3mm and 3) zero clinical attachment loss. The study participants were randomly assigned into two groups i.e., Group I- Chlorhexidine Gluconate (CHX) gel, Group II- combination gel of Chlorhexidine gluconate and Metronidazole (CHX-MTZ) gel. Clinical parameters viz. Gingival Index (GI) and Modified Sulcus bleeding index (MSBI) were recorded firstly at baseline after Scaling and Root Planing(SRP), and secondly at the end of the study period of two weeks. Intra and inter-group comparisons of clinical parameters were done using appropriate statistical tests. Results There was high significant reduction in GI and MSBI scores at the end of 2 weeks period in both the groups. Further, combination gel of Group II (CHX+MTZ) was found to be statistically more effective as compared to Group I (CHX) used alone. Conclusions Our study suggests that Chemotherapeutic agents like CHX and combination CHX-MTZ Gel are clinically effective as adjunct to Scaling and Root Planning(SRP) in treatment of Chronic Gingivitis. Further, post statistical comparative analysis has proved CHX-MTZ combination gel regime to be more clinically effective than CHX gel used alone in treatment of Chronic Gingivitis as adjunct to SRP. Key words: Scaling and Root Planning (SRP), Chronic Gingivitis, Chlorhexidine Gluconate (CHX) gel, Combination (CHX+MTZ) Gel, Metronidazole (MTZ).",2021,There was high significant reduction in GI and MSBI scores at the end of 2 weeks period in both the groups.,"['60 systemically healthy patients with 1) chronic generalized gingivitis (MGI>1), 2) probing depth ≤ 3mm and 3) zero clinical attachment loss', 'chronic gingivitis', 'chronic gingivitis patients']","['combination gel of Group II (CHX+MTZ', 'topical antimicrobial gels', 'Root Planning (SRP), Chronic Gingivitis, Chlorhexidine Gluconate (CHX) gel, Combination (CHX+MTZ', 'CHX-MTZ Gel', 'Chlorhexidine Gluconate (CHX) gel, Group II- combination gel of Chlorhexidine gluconate and Metronidazole (CHX-MTZ) gel', 'CHX gel', 'Gel, Metronidazole (MTZ']","['Gingival Index (GI) and Modified Sulcus bleeding index (MSBI', 'GI and MSBI scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0008684', 'cui_str': 'Chronic gingivitis'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0055361', 'cui_str': 'Chlorhexidine gluconate'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}]","[{'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.0145634,There was high significant reduction in GI and MSBI scores at the end of 2 weeks period in both the groups.,"[{'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Mishra', 'Affiliation': 'Junior Resident, Department of Dentistry, Gandhi Medical College and Hamidia Hospital, Bhopal, M.P, India.'}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Bhargava', 'Affiliation': 'Associate Professor, Department of Dentistry, Gandhi Medical College and Hamidia, Hospital Bhopal, M.P, India.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Nigam-Gupta', 'Affiliation': 'Senior Resident, Department of Dentistry, Gandhi Medical College and Hamidia Hospital, Bhopal, M.P, India.'}]",Journal of clinical and experimental dentistry,['10.4317/jced.57635'] 3374,33841727,Evaluation of the effect of a school garden as an educational didactic tool in vegetable and fruit consumption in teenagers.,"BACKGROUND/OBJECTIVES Increasing the consumption of vegetables and fruits in Mexico remains a challenge. Promoting sustainable food production systems through schools may be an effective way to educate young people about food and nutrition issues. A study of nutritional education in adolescents, based on the school garden, is necessary in order to evaluate its effects on the consumption of fruits and vegetables among middle- and upper-income segments of the population. The objective of this study was to evaluate the effect of an educational intervention, accompanied by a school garden as an educational teaching tool, to improve vegetable and fruit consumption by Mexican teenagers attending a private middle/high school. SUBJECTS/METHODS Teenagers between 12 and 18 years of age (n = 126) attending a private middle/high school in Queretaro, Mexico participated in a 3-arm, controlled, comparative impact study using a vegetable and fruit consumption frequency questionnaire, food consumption diaries, a psychosocial factor assessment questionnaire of vegetable and fruit consumption, and structured interviews. The participants were randomized into 3 experimental groups: 1) food education + school garden (FE + SG), 2) FE only, and 3) control group (CG). RESULTS The FE + SG and FE groups significantly increased the frequency and daily intake of vegetables and fruits compared to the CG. The FE + SG group showed greater understanding of, reflection upon, and analysis of the information they received about vegetable and fruit consumption, as well as a greater willingness to include these in their daily diet. CONCLUSIONS FE accompanied by a SG as a teaching tool is more effective at promoting vegetable and fruit consumption than either education alone or control in teenagers in middle-upper income segments of the population.",2021,"The FE + SG group showed greater understanding of, reflection upon, and analysis of the information they received about vegetable and fruit consumption, as well as a greater willingness to include these in their daily diet. ","['Mexican teenagers attending a private middle/high school', 'vegetable and fruit consumption in teenagers', 'Teenagers between 12 and 18 years of age (n = 126) attending a private middle/high school in Queretaro, Mexico participated']","['educational intervention', 'school garden', 'FE + SG', 'food education + school garden (FE + SG), 2) FE only, and 3) control group (CG', 'vegetable and fruit consumption frequency questionnaire, food consumption diaries, a psychosocial factor assessment questionnaire of vegetable and fruit consumption, and structured interviews']",['frequency and daily intake of vegetables and fruits'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0868963', 'cui_str': 'Gardening'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}]",126.0,0.0183988,"The FE + SG group showed greater understanding of, reflection upon, and analysis of the information they received about vegetable and fruit consumption, as well as a greater willingness to include these in their daily diet. ","[{'ForeName': 'Diana Gabriela', 'Initials': 'DG', 'LastName': 'Figueroa-Piña', 'Affiliation': 'Facultad de Ciencias Naturales, Campus Juriquilla, Universidad Autónoma de Querétaro, Querétaro, Qro. CP 76230, México.'}, {'ForeName': 'Jorge Luis', 'Initials': 'JL', 'LastName': 'Chávez-Servín', 'Affiliation': 'Facultad de Ciencias Naturales, Campus Juriquilla, Universidad Autónoma de Querétaro, Querétaro, Qro. CP 76230, México.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'de la Torre-Carbot', 'Affiliation': 'Facultad de Ciencias Naturales, Campus Juriquilla, Universidad Autónoma de Querétaro, Querétaro, Qro. CP 76230, México.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Del Carmen Caamaño-Pérez', 'Affiliation': 'Facultad de Ciencias Naturales, Campus Juriquilla, Universidad Autónoma de Querétaro, Querétaro, Qro. CP 76230, México.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Lucas-Deecke', 'Affiliation': 'Centro de Innovación de Agricultura Sostenible en Pequeña Escala, A.C. CIASPE, Querétaro, Qro. CP 76246, México.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Roitman-Genoud', 'Affiliation': 'Facultad de Ciencias Naturales, Campus Juriquilla, Universidad Autónoma de Querétaro, Querétaro, Qro. CP 76230, México.'}, {'ForeName': 'Laura Regina', 'Initials': 'LR', 'LastName': 'Ojeda-Navarro', 'Affiliation': 'Facultad de Ciencias Naturales, Campus Juriquilla, Universidad Autónoma de Querétaro, Querétaro, Qro. CP 76230, México.'}]",Nutrition research and practice,['10.4162/nrp.2021.15.2.235'] 3375,33841714,Effects of rehabilitation nursing care on deep vein thrombosis of the lower limbs following spinal fractures.,"OBJECTIVE To explore the preventive effect of rehabilitation nursing care for deep vein thrombosis (DVT) of the lower limbs following spinal fractures, and to analyze its influence on the hemorheology of patients. METHODS A total of 99 patients with spinal fractures were allocated into a study group (n=50) and control group (n=49), and they were treated with internal fixation plus vertebroplasty. Afterwards, patients in the control group were given routine care and postoperative rehabilitation, and those in the study group received rehabilitation nursing care on the day after surgery, including posture guidance, massage of both lower limbs, and functional training. The functional training was consecutively performed until free movement of the legs was possible. All patients were reexamined after three months. The incidence of low-limb DVT, pain, and swelling, as well as the degree of swelling, hemorheology, quality of life, and patient satisfaction were compared between the two groups. RESULTS The study group had less frequent low-limb DVT, pain and swelling than the control group (all P<0.05). In the study group, the degree of swelling was significantly reduced, with earlier return to normal activity and shorter hospital stay (all P<0.05). After intervention, plasma viscosity, whole blood low/high shear viscosity and erythrocyte aggregation (EA) decreased in both groups, especially in the study group (all P<0.05). Although GQOL-74 scores increased in both groups, there was a more significant increase that occurred in study group (all P<0.001). Patients in the study group were more satisfied with nursing services than those in the control group (P<0.05). CONCLUSION Rehabilitation nursing care contributes to the improvement of hypercoagulable states and the prevention of lower-limb DVT for surgically treated patients with spinal fractures, and it is effective in relieving pain and swelling of the lower limbs, thereby enhancing quality of life and patient satisfaction.",2021,"After intervention, plasma viscosity, whole blood low/high shear viscosity and erythrocyte aggregation (EA) decreased in both groups, especially in the study group (all P<0.05).","['spinal fractures', 'surgically treated patients with spinal fractures', '99 patients with spinal fractures']","['internal fixation plus vertebroplasty', 'rehabilitation nursing care on the day after surgery, including posture guidance, massage of both lower limbs, and functional training', 'routine care and postoperative rehabilitation', 'rehabilitation nursing care']","['deep vein thrombosis', 'GQOL-74 scores', 'normal activity and shorter hospital stay', 'degree of swelling', 'frequent low-limb DVT, pain and swelling', 'satisfied with nursing services', 'incidence of low-limb DVT, pain, and swelling, as well as the degree of swelling, hemorheology, quality of life, and patient satisfaction', 'plasma viscosity, whole blood low/high shear viscosity and erythrocyte aggregation (EA']","[{'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1303192', 'cui_str': 'Vertebroplasty'}, {'cui': 'C0376427', 'cui_str': 'Nursing, Rehabilitation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}]","[{'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0340708', 'cui_str': 'Deep venous thrombosis of lower extremity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0028697', 'cui_str': 'Nursing service'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0206502', 'cui_str': 'Hemorrheology'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0427685', 'cui_str': 'Plasma viscosity measurement'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}, {'cui': 'C0014766', 'cui_str': 'Erythrocyte Aggregation'}]",99.0,0.0116499,"After intervention, plasma viscosity, whole blood low/high shear viscosity and erythrocyte aggregation (EA) decreased in both groups, especially in the study group (all P<0.05).","[{'ForeName': 'Zhijuan', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Department of Rehabilitation Medicine, Linyi Central Hospital Linyi, Shandong Province, China.'}, {'ForeName': 'Qifeng', 'Initials': 'Q', 'LastName': 'Tian', 'Affiliation': 'Department of Rehabilitation Medicine, Linyi Central Hospital Linyi, Shandong Province, China.'}, {'ForeName': 'Benyan', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Medicine, Linyi Central Hospital Linyi, Shandong Province, China.'}]",American journal of translational research,[] 3376,33841713,Effect of enhanced recovery after surgery on patients with malignant obstructive jaundice complicated with diabetes mellitus.,"OBJECTIVE To explore the effect of enhanced recovery after surgery on patients with malignant obstructive jaundice complicated with diabetes mellitus. METHODS Patients with malignant obstructive jaundice complicated with diabetes mellitus received surgery in Hengshui People's Hospital were divided into two groups: patients in one group received routine care (routine care group, RC group), and patients in another group received enhanced recovery after surgery on the basis of routine care (accelerated care group, AC group). The differences in patients' satisfaction with care and nursing effects between the two groups were compared. RESULTS The scores of nursing effects such as nursing records and surgical safety in the RC group were significantly lower than those in the AC group (P<0.001). The psychological state of patients in the AC group was better than that in the RC group after care (P<0.001). The nursing-sensitive quality indicators, the quality of life scores and the patients' nursing satisfaction in the AC group were all higher than those in the RC group (P<0.001). The incidence of adverse events in the AC group was significantly lower than that in the RC group (P=0.01). CONCLUSION Compared with routine care, the effect of enhanced recovery after surgery is better on patients with malignant obstructive jaundice complicated with diabetes mellitus.",2021,The scores of nursing effects such as nursing records and surgical safety in the RC group were significantly lower than those in the AC group (P<0.001).,"[""Patients with malignant obstructive jaundice complicated with diabetes mellitus received surgery in Hengshui People's Hospital"", 'patients with malignant obstructive jaundice complicated with diabetes mellitus']","['routine care (routine care group, RC group), and patients in another group received enhanced recovery after surgery on the basis of routine care (accelerated care group, AC group']","['scores of nursing effects such as nursing records and surgical safety', 'satisfaction with care and nursing effects', 'incidence of adverse events', ""quality of life scores and the patients' nursing satisfaction""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0022354', 'cui_str': 'Obstructive hyperbilirubinemia'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0028694', 'cui_str': 'Records, Nursing'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",,0.0287218,The scores of nursing effects such as nursing records and surgical safety in the RC group were significantly lower than those in the AC group (P<0.001).,"[{'ForeName': 'Huijun', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': ""Department of Hepatobiliary and Pancreatic Surgery, Hengshui People's Hospital Hengshui, Hebei Province, China.""}, {'ForeName': 'Shuangyu', 'Initials': 'S', 'LastName': 'Qi', 'Affiliation': ""Department of Hepatobiliary and Pancreatic Surgery, Hengshui People's Hospital Hengshui, Hebei Province, China.""}, {'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Cui', 'Affiliation': ""Electroencephalogram Room, The No.4 People's Hospital of Hengshui, Orthopedics Department Hospital Hengshui, Hebei Province, China.""}, {'ForeName': 'Binghui', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': ""Department of Hepatobiliary and Pancreatic Surgery, Hengshui People's Hospital Hengshui, Hebei Province, China.""}, {'ForeName': 'Guimei', 'Initials': 'G', 'LastName': 'Du', 'Affiliation': ""Department of Neonatology, Hengshui People's Hospital Hengshui, Hebei Province, China.""}]",American journal of translational research,[] 3377,33841704,Effects of care bundles for patients with pressure ulcers and the impact on self-care efficacy.,"OBJECTIVE To investigate the effects of care bundles for patients with pressure ulcers and the impact on self-care efficacy. METHOD A total of 160 patients with pressure ulcers were enrolled and divided into two groups using a lottery method. The control group (n=80) was cared for with routine nursing while the observation group (n=80) was additionally nursed with care bundles for 3 months. Both groups were compared in terms of grading of pressure ulcers, self-care efficacy, pressure ulcer management, awareness rate, and quality of life. RESULTS At 3 months after nursing, the grading of pressure ulcers was significantly improved in both groups. The observation group exhibited higher incidence of pressure ulcers, unstageable and deep tissue injury than the control group ( P <0.05). DSES scores were improved in both groups ( P <0.05). Scores of daily living, health behavior, compliance behavior, and emotional management in the observation group were higher than those in the control group ( P <0.05). The skills of pressure ulcer management were strengthened in both groups ( P <0.05). Scores of nutritional support, repositioning, skin care, dressing changes, and pressure ulcer assessment in the observation group were higher than those in the control group ( P <0.05). The observation group also exhibited higher scores in terms of diet, pressure ulcer monitoring, lesion staging, complications and knowledge of pressure ulcer triggers than the control group ( P <0.05). Quality of life was significantly improved in both groups after 3 months of nursing. PH, RP, BP, GH, VT, SF, RE and MH scores in the observation group were higher than those in the control group ( P <0.05). CONCLUSION Care bundles can improve pressure ulcer grading, enhance patient self-care efficacy and skills of pressure ulcer management, and help improve patient awareness rates and quality of life for patients with pressure ulcers, which is worth of promoting.",2021,"Both groups were compared in terms of grading of pressure ulcers, self-care efficacy, pressure ulcer management, awareness rate, and quality of life. ","['160 patients with pressure ulcers', 'patients with pressure ulcers']",['routine nursing while the observation group'],"['self-care efficacy', 'skills of pressure ulcer management', 'patient awareness rates and quality of life', 'Quality of life', 'pressure ulcers, self-care efficacy, pressure ulcer management, awareness rate, and quality of life', 'Scores of nutritional support, repositioning, skin care, dressing changes, and pressure ulcer assessment', 'diet, pressure ulcer monitoring, lesion staging, complications and knowledge of pressure ulcer triggers', 'pressure ulcers, unstageable and deep tissue injury', 'grading of pressure ulcers', 'Scores of daily living, health behavior, compliance behavior, and emotional management', 'PH, RP, BP, GH, VT, SF, RE and MH scores', 'DSES scores']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011127', 'cui_str': 'Pressure ulcer'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0558009', 'cui_str': 'Pressure ulcer care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011127', 'cui_str': 'Pressure ulcer'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}, {'cui': 'C0556030', 'cui_str': 'Repositioning'}, {'cui': 'C0150773', 'cui_str': 'Skin care'}, {'cui': 'C0085671', 'cui_str': 'Change of dressing'}, {'cui': 'C0558031', 'cui_str': 'Pressure ulcer assessment'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0332305', 'cui_str': 'With staging'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C4552279', 'cui_str': 'Tissue injury'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",160.0,0.00955407,"Both groups were compared in terms of grading of pressure ulcers, self-care efficacy, pressure ulcer management, awareness rate, and quality of life. ","[{'ForeName': 'Xiaodan', 'Initials': 'X', 'LastName': 'Mao', 'Affiliation': ""Department of Burn, The First People's Hospital of Wenling Wenling 317500, Zhejiang Province, China.""}, {'ForeName': 'Lipeng', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': ""Department of Burn, The First People's Hospital of Wenling Wenling 317500, Zhejiang Province, China.""}]",American journal of translational research,[] 3378,33841703,Effects of acupoint catgut embedding on the postmenopausal osteoporosis patients and related mechanism.,"OBJECTIVE To study the effect and mechanism of acupoint catgut embedding on patients of postmenopausal osteoporosis (PMOP). METHODS In this prospective study, 90 patients with PMOP who received treatment in our hospital were randomly divided into the drug treatment group (n=45) and drug treatment + catgut embedding group (n=45) according to SPSS random table method. The drug treatment group was given conventional western medicine treatment, and the drug treatment + catgut embedding group was given point embedding therapy. Bone mineral density (BMD), calcium (Ca 2+ ), osteoprotegerin (OPG), estrogen (E 2 ), receptor activator of nuclear factor-kB ligand (RANKL), liver and kidney function and blood lipids were detected before treatment in the two groups, and visual analogue score (VAS) and PMOP symptom score were evaluated. The above-mentioned indexes were detected again 3 months and 6 months after treatment. RESULTS At 3 and 6 months after treatment, the BMD and the levels of Ca 2+ and E 2 in the two groups were increased, while the levels of OPG and RANKL were decreased, and the improvement in the drug treatment + catgut embedding group was significantly better than that in the drug treatment group (P<0.05). The symptom scores of VAS and PMOP in the drug treatment + catgut embedding group were significantly lower than those in the drug treatment group (all P<0.001). There was no significant difference in the levels of alanine aminotransferase (ALT), total bilirubin (TBil), albumin (ALB), blood urea nitrogen (BUN), serum creatinine (SCr) and serum uric acid (SUA) between the two groups, but the levels of total cholesterol (TC) and triglyceride (TG) in the drug treatment + catgut embedding group were significantly lower than those in the drug treatment group (all P<0.001). CONCLUSION Acupoint catgut embedding has a good effect on PMOP, and it can increase BMO and improve the clinical symptoms of patients, which is worthy of clinical promotion.",2021,"There was no significant difference in the levels of alanine aminotransferase (ALT), total bilirubin (TBil), albumin (ALB), blood urea nitrogen (BUN), serum creatinine (SCr) and serum uric acid (SUA) between the two groups, but the levels of total cholesterol (TC) and triglyceride (TG) in the drug treatment + catgut embedding group were significantly lower than those in the drug treatment group (all P<0.001). ","['90 patients with PMOP who received treatment in our hospital', 'patients of postmenopausal osteoporosis (PMOP', 'postmenopausal osteoporosis patients and related mechanism']","['acupoint catgut embedding', 'drug treatment + catgut embedding group (n=45) according to SPSS random table method', 'conventional western medicine treatment, and the drug treatment + catgut embedding group was given point embedding therapy']","['BMD and the levels of Ca 2+ and E 2', 'visual analogue score (VAS) and PMOP symptom score', 'levels of total cholesterol (TC) and triglyceride (TG', 'Bone mineral density (BMD), calcium (Ca 2+ ), osteoprotegerin (OPG), estrogen (E 2 ), receptor activator of nuclear factor-kB ligand (RANKL), liver and kidney function and blood lipids', 'symptom scores of VAS and PMOP', 'levels of OPG', 'levels of alanine aminotransferase (ALT), total bilirubin (TBil), albumin (ALB), blood urea nitrogen (BUN), serum creatinine (SCr) and serum uric acid (SUA', 'BMO']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029458', 'cui_str': 'Postmenopausal osteoporosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}]","[{'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0007420', 'cui_str': 'Catgut'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0039224', 'cui_str': 'Table'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0596235', 'cui_str': 'Calcium ion'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0029458', 'cui_str': 'Postmenopausal osteoporosis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0538161', 'cui_str': 'Tumor Necrosis Factor Receptor 11b'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C4543210', 'cui_str': 'Receptor activator'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}]",90.0,0.0120222,"There was no significant difference in the levels of alanine aminotransferase (ALT), total bilirubin (TBil), albumin (ALB), blood urea nitrogen (BUN), serum creatinine (SCr) and serum uric acid (SUA) between the two groups, but the levels of total cholesterol (TC) and triglyceride (TG) in the drug treatment + catgut embedding group were significantly lower than those in the drug treatment group (all P<0.001). ","[{'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Shi', 'Affiliation': 'Second Clinical College, Nanjing University of Chinese Medicine Nanjing, Jiangsu Province, China.'}, {'ForeName': 'Chunli', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': ""The Second Department of Stroke, Tai'an Second Hospital of TCM Tai'an, Shandong Province, China.""}, {'ForeName': 'Chenglong', 'Initials': 'C', 'LastName': 'Fang', 'Affiliation': ""Department of Rehabilitation, Linyi People's Hospital Linyi, Shandong Province, China.""}, {'ForeName': 'Dongning', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': ""Department of Rehabilitation, Linyi People's Hospital Affiliated to The 11th Clinical Medical College of Qingdao University Linyi, Shandong Province, China.""}, {'ForeName': 'Zhou', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': ""Department of Rehabilitation, Linyi People's Hospital Affiliated to The 11th Clinical Medical College of Qingdao University Linyi, Shandong Province, China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Ouyang', 'Affiliation': 'Department of Traditional Medicine, Jiangsu Province Geriatric Hospital Nanjing, Jiangsu Province, China.'}]",American journal of translational research,[] 3379,33841702,Exercise intervention can reduce the degree of drug dependence of patients with amphetamines/addiction by improving dopamine level and immunity and reducing negative emotions.,"OBJECTIVE Exercise intervention can reduce drug dependence of patients with amphetamines addiction by improving dopamine level and immunity, and reducing negative emotions. METHODS Altogether 90 male patients with amphetamines addiction from March 2018 to June 2019 were selected and grouped. The routine rehabilitation group (RG) (30 cases) was given conventional rehabilitation treatment, while group 1 (30 cases) was given conventional rehabilitation treatment+aerobic exercise for 1 hour. Group 2 (30 cases) received routine rehabilitation+aerobic exercise+strength training for 1 hour. Before and after exercise intervention, the three groups were tested for psychological state with self-rating depression scale (SDS). Visual analogue scale (VAS) was used to evaluate the drug craving. Positive and negative syndrome scale (PANSS) and quality of life scale for drug addiction (QOL-DA) were used to detect the mental status and QOL. The immune function, high sensitivity C-reactive protein (hs-CRP) and dopamine (DA) levels were detected. RESULTS After intervention, the SDS, VAS and PANSS of group 1 and group 2 weresignificantly better than those of RG, while the improvement of scores of group 2 wassignificantly better than that of group 1 (P < 0.05). hs-CRP in group 1 and group 2 were significantly lower than those in RG, while hs-CRP in group 2 weresignificantly lower than those in group 1 (P < 0.05). IgA, IgG and DA in group 1 and group 2 weresignificantly higher than those in RG, and IgA, IgG and DA in group 2 weresignificantly higher than those in group 1 (P < 0.05). QOL-DA in group 1 and 2 weresignificantly higher than those of RG, and the improvement of scores of group 2 wassignificantly better than that of group 1 (P < 0.05). CONCLUSION Psychological status, drug craving, immune function, DA and QOL of patients with amphetamines addiction have been improved after exercise intervention.",2021,"IgA, IgG and DA in group 1 and group 2 weresignificantly higher than those in RG, and IgA, IgG and DA in group 2 weresignificantly higher than those in group 1 (P < 0.05).","['patients with amphetamines addiction', '90 male patients with amphetamines addiction from March 2018 to June 2019 were selected and grouped', 'patients with amphetamines/addiction']","['routine rehabilitation group (RG) (30 cases) was given conventional rehabilitation treatment', 'Exercise intervention', 'conventional rehabilitation treatment+aerobic exercise', 'routine rehabilitation+aerobic exercise+strength training']","['QOL-DA', 'Psychological status, drug craving, immune function, DA and QOL', 'psychological state with self-rating depression scale (SDS', 'immune function, high sensitivity C-reactive protein (hs-CRP) and dopamine (DA) levels', 'Visual analogue scale (VAS', 'Positive and negative syndrome scale (PANSS) and quality of life scale for drug addiction (QOL-DA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0236804', 'cui_str': 'Amphetamine dependence'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C1510472', 'cui_str': 'Drug dependence'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0556446', 'cui_str': 'Craves for drugs'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}]",90.0,0.0108999,"IgA, IgG and DA in group 1 and group 2 weresignificantly higher than those in RG, and IgA, IgG and DA in group 2 weresignificantly higher than those in group 1 (P < 0.05).","[{'ForeName': 'Qinghua', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': 'School of Physical Education and Health Science, Guangxi University for Nationalities Nanning 530006, Guangxi, China.'}, {'ForeName': 'Jingqiong', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Physical Education, Guangxi Medical University Nanning 530021, Guangxi, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The Sixth Compulsory Isolation and Rehabilitation Center of Guangxi Beihai 536000, Guangxi Province, China.'}, {'ForeName': 'Fuxuan', 'Initials': 'F', 'LastName': 'Luo', 'Affiliation': 'The Sixth Compulsory Isolation and Rehabilitation Center of Guangxi Beihai 536000, Guangxi Province, China.'}, {'ForeName': 'Kaihui', 'Initials': 'K', 'LastName': 'Yan', 'Affiliation': 'The Sixth Compulsory Isolation and Rehabilitation Center of Guangxi Beihai 536000, Guangxi Province, China.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'School of Physical Education and Health Science, Guangxi University for Nationalities Nanning 530006, Guangxi, China.'}, {'ForeName': 'Zaimei', 'Initials': 'Z', 'LastName': 'Mo', 'Affiliation': 'School of Physical Education and Health Science, Guangxi University for Nationalities Nanning 530006, Guangxi, China.'}, {'ForeName': 'Xinping', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'School of Physical Education and Health Science, Guangxi University for Nationalities Nanning 530006, Guangxi, China.'}]",American journal of translational research,[] 3380,33841699,Effect of care bundles in the nursing of severe pneumonia.,"OBJECTIVE To explore the effect of care bundles and analyze the influence of different angles of turning over on the sputum excretion of mechanically ventilated patients with severe pneumonia. METHODS 120 patients with severe pneumonia in our hospital from October 2016 to October 2019 were equally randomized into four groups, each with 30, according to the date of admission. The control group was given conventional nursing and placed in a position of left 30°-half lying-right 30°; the group A was given comprehensive care bundles and placed in a position of left 30°-half lying-right 30°; the group B was given comprehensive care bundles and placed in a position of left 45°-half lying-right 45°, and the group C was given comprehensive care bundles and placed in a position of 60° left-half lying-60° right. The respiratory rates and oxygenation indexes of patients in the three groups (group A, B, C) in lateral position at 2 h and 6 h respectively before and after mechanical ventilation were compared. And we compared the nursing efficiency and satisfaction. RESULTS The control group showed lower nursing efficiency and satisfaction compared with the group A (P<0.05). The group B and C showed higher oxygenation index after six hours of ventilation compared with group A (P<0.05). After two hours of mechanical ventilation, the group B and C showed lower respiratory rate and higher oxygenation index compared with the group A, and the respiratory rate and oxygenation index of the group B were closest to the normal range (P<0.05). CONCLUSION The sputum excretion effect of mechanically ventilated patients with severe pneumonia was the best if they were placed in a position of left 45°-half lying-right 45° and given comprehensive care bundles.",2021,The group B and C showed higher oxygenation index after six hours of ventilation compared with group A (P<0.05).,"['120 patients with severe pneumonia in our hospital from October 2016 to October 2019', 'mechanically ventilated patients with severe pneumonia']","['conventional nursing and placed in a position of left 30°-half lying-right 30°; the group A was given comprehensive care bundles and placed in a position of left 30°-half lying-right 30°; the group B was given comprehensive care bundles and placed in a position of left 45°-half lying-right 45°, and the group C was given comprehensive care bundles and placed in a position of 60° left-half lying-60° right']","['nursing efficiency and satisfaction', 'oxygenation index', 'sputum excretion effect', 'lower respiratory rate and higher oxygenation index', 'respiratory rate and oxygenation index', 'respiratory rates and oxygenation indexes']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0009586', 'cui_str': 'Comprehensive Healthcare'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0205091', 'cui_str': 'Left'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0231837', 'cui_str': 'Slow respiration'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}]",120.0,0.0197397,The group B and C showed higher oxygenation index after six hours of ventilation compared with group A (P<0.05).,"[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Emergency Intensive Care Unit, The People's Hospital of Langfang City Langfang, China.""}, {'ForeName': 'Meiqin', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""Emergency Intensive Care Unit, The People's Hospital of Langfang City Langfang, China.""}, {'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': ""Emergency Intensive Care Unit, The People's Hospital of Langfang City Langfang, China.""}, {'ForeName': 'Hongjuan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Emergency Intensive Care Unit, The People's Hospital of Langfang City Langfang, China.""}, {'ForeName': 'Huiling', 'Initials': 'H', 'LastName': 'He', 'Affiliation': ""Emergency Intensive Care Unit, The People's Hospital of Langfang City Langfang, China.""}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ""Hospital of People's Public Security University of China Beijing, China.""}]",American journal of translational research,[] 3381,33841697,"Effects of off-pump coronary artery bypass grafting on clinical efficacy, cardiac function and the incidence of major adverse cardiovascular events in patients with coronary heart disease.","OBJECTIVE To explore the effects of off-pump coronary artery bypass grafting (OPC) on clinical efficacy, cardiac function and the occurrence of major adverse cardiovascular events (MACE) in patients with coronary heart disease. METHODS According to different surgical methods, 93 patients with coronary heart disease who were hospitalized and treated in our hospital were collapsed into the off-pump coronary artery bypass grafting group (OPC group) and the extracorporeal circulation coronary artery bypass grafting group (PC group). The perioperative indexes, cardiac function indexes, postoperative recovery, quality of life, the incidence of MACE and adverse reactions and the survival rate of patients in PC group and OPC group were analyzed and compared. RESULTS Compared with the PC group, the operation time and blood transfusion volume of OPC group were both largely decreased (P<0.05), but the number of bypass grafts was similar (P>0.05). The cardiac function index of OPC group was much higher than that of PC group (P<0.05). The postoperative recovery after operation of OPC group was better than that of PC group (P<0.05). The scores of quality of life scale in OPC group were markedly higher than those in PC group (P<0.05). The incidence of MACE in OPC group was obviously lower than that in PC group (P<0.05). Patients in in the OPC group had slightly lower incidence of adverse reactions, and slightly higher survival rate than the PC group, but there was no statistical difference (P>0.05). CONCLUSION Compared with PC, OPC has a significantly better therapeutic effect on patients with coronary heart disease, which can significantly improve the perioperative indices and cardiac function, and enhance the quality of life of patients.",2021,The postoperative recovery after operation of OPC group was better than that of PC group (P<0.05).,"['93 patients with coronary heart disease who were hospitalized and treated in our hospital were collapsed into the off', 'patients with coronary heart disease']","['PC, OPC', 'OPC', 'pump coronary artery bypass grafting group (OPC group) and the extracorporeal circulation coronary artery bypass grafting group (PC group', 'pump coronary artery bypass grafting', 'pump coronary artery bypass grafting (OPC']","['clinical efficacy, cardiac function and the incidence of major adverse cardiovascular events', 'quality of life', 'number of bypass grafts', 'perioperative indices and cardiac function', 'operation time and blood transfusion volume', 'cardiac function index', 'incidence of MACE', 'perioperative indexes, cardiac function indexes, postoperative recovery, quality of life, the incidence of MACE and adverse reactions and the survival rate', 'adverse reactions', 'survival rate', 'scores of quality of life scale', 'clinical efficacy, cardiac function and the occurrence of major adverse cardiovascular events (MACE', 'postoperative recovery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C1518543', 'cui_str': 'Off'}]","[{'cui': 'C1449706', 'cui_str': 'Off-pump coronary artery bypass'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015354', 'cui_str': 'Extracorporeal circulation procedure'}]","[{'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0185098', 'cui_str': 'Bypass graft'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",93.0,0.0156651,The postoperative recovery after operation of OPC group was better than that of PC group (P<0.05).,"[{'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Ma', 'Affiliation': 'The First Department of Cardiac Surgery, Tangshan Gongren Hospital Tangshan, Hebei Province, China.'}, {'ForeName': 'Jiancheng', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'The First Department of Cardiac Surgery, Tangshan Gongren Hospital Tangshan, Hebei Province, China.'}, {'ForeName': 'Chunbo', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'The First Department of Cardiac Surgery, Tangshan Gongren Hospital Tangshan, Hebei Province, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'The First Department of Cardiac Surgery, Tangshan Gongren Hospital Tangshan, Hebei Province, China.'}]",American journal of translational research,[] 3382,33841696,Study of the therapeutic effects of betamethasone injection combined with musculoskeletal ultrasonography compared with radial shock wave therapy in the treatment of tenosynovitis of the long head of the biceps brachii.,"OBJECTIVE To compare the therapeutic effects of compound betamethasone injection (CBI) combined with musculoskeletal ultrasonography (MSUS) and radial shock wave therapy (RSWT) in the treatment of tenosynovitis of the long head of the biceps brachii tendon (TLHBBT). METHODS A total of 93 patients with TLHBBT admitted to our hospital were selected and randomly divided into an observation group (n=48) and a control group (n=45). The control group received RSWT, while the observation group received CBI combined with MSUS. The therapeutic effects were compared between the two groups. RESULTS The visual analog scale scores for the affected sites in the observation group were lower than those in the control group immediately after treatment and at 1, 2 and 4 weeks after treatment, while the constant-Murley scale scores for the active range of motion for shoulder forward flexion and shoulder joint function in the observation group were higher than those in the control group ( P < 0.05). After treatment, the positive rate in Yergason's test in the observation group (2.08%) was lower than that in the control group (15.56%), while the negative rate in the observation group (97.92%) was higher than that in the control group (84.44%) ( P < 0.05). The overall response rate (ORR) in the observation group (93.75%) was higher than that in the control group (80.00%) ( P < 0.05). CONCLUSION CBI combined with MSUS, is superior to RSWT in treating TLHBBT, and it can remarkably reduce pain, increase joint range of motion, and improve joint function.",2021,"The visual analog scale scores for the affected sites in the observation group were lower than those in the control group immediately after treatment and at 1, 2 and 4 weeks after treatment, while the constant-Murley scale scores for the active range of motion for shoulder forward flexion and shoulder joint function in the observation group were higher than those in the control group ( P < 0.05).","['93 patients with TLHBBT admitted to our hospital', 'tenosynovitis of the long head of the biceps brachii']","['compound betamethasone injection (CBI) combined with musculoskeletal ultrasonography (MSUS) and radial shock wave therapy (RSWT', 'RSWT', 'radial shock wave therapy', 'CBI combined with MSUS', 'betamethasone injection combined with musculoskeletal ultrasonography']","['visual analog scale scores', 'negative rate', 'overall response rate (ORR', 'pain, increase joint range of motion, and improve joint function', ""positive rate in Yergason's test"", 'shoulder forward flexion and shoulder joint function', 'therapeutic effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0039520', 'cui_str': 'Tenosynovitis'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}]","[{'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0542330', 'cui_str': 'Joint mobilization'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0231658', 'cui_str': ""Yergason's test""}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0037009', 'cui_str': 'Joint structure of shoulder region'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",93.0,0.0350762,"The visual analog scale scores for the affected sites in the observation group were lower than those in the control group immediately after treatment and at 1, 2 and 4 weeks after treatment, while the constant-Murley scale scores for the active range of motion for shoulder forward flexion and shoulder joint function in the observation group were higher than those in the control group ( P < 0.05).","[{'ForeName': 'Lizhen', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of Ultrasound Medicine, Hainan West Central Hospital Danzhou 571700, Hainan Province, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': 'Department of Ultrasound Medicine, Hainan West Central Hospital Danzhou 571700, Hainan Province, China.'}, {'ForeName': 'Fengkai', 'Initials': 'F', 'LastName': 'Fang', 'Affiliation': 'Department of Ultrasound Medicine, Hainan West Central Hospital Danzhou 571700, Hainan Province, China.'}]",American journal of translational research,[] 3383,33841694,Effect of predictive nursing on postoperative rehabilitation and complications of patients undergoing hip replacement and maintenance hemodialysis.,"OBJECTIVE To analyze the effect of predictive nursing on postoperative rehabilitation index and complications in patients after hip replacement with maintenance hemodialysis. METHODS A total of 81 cases of patients underwent hip replacement and maintenance hemodialysis in our hospital were selected as the research objects and divided into study group (n=41) and control group (n=40) with retrospective analysis method based on different intervention method. Patients in the study group received predictive nursing, while patients in the control group received routine nursing. The hip function and activity, duration of walking with and without crutches, adverse emotions, pain and the incidence of various complications after intervention were compared between the two groups. RESULTS There was no significant difference in Harris score between the two groups at 7 days after intervention ( P >0.05); the Harris scores of the study group were significantly higher than those of the control group ( P <0.05) at 1, 3 and 6 months after intervention. Before intervention, there was no significant difference in hip activity between the two groups ( P >0.05); 3 months surgery operation, the hip extension, abduction and rotation angle of the study group were significantly higher than those of the control group ( P <0.05); the duration of walking with and without crutches in the study group were significantly shorter than those in the control group ( P <0.05); the scores of adverse emotions, pain and complications in the study group were significantly lower than those in the control group ( P <0.05). CONCLUSION The implementation of predictive nursing to patients underwent hip replacement and maintenance hemodialysis can improve hip activity and joint function after surgery, accelerate postoperative recovery, relieve postoperative pain symptoms, and reduce the incidence of various complications.",2021,"There was no significant difference in Harris score between the two groups at 7 days after intervention ( P >0.05); the Harris scores of the study group were significantly higher than those of the control group ( P <0.05) at 1, 3 and 6 months after intervention.","['81 cases of patients underwent hip replacement and maintenance hemodialysis in our hospital were selected as the research objects and divided into study group (n=41) and control group (n=40) with retrospective analysis method based on different intervention method', 'patients after hip replacement with maintenance hemodialysis', 'patients undergoing hip replacement and maintenance hemodialysis']","['predictive nursing', 'hip replacement and maintenance hemodialysis', 'routine nursing']","['Harris score', 'hip extension, abduction and rotation angle', 'postoperative pain symptoms', 'duration of walking with and without crutches', 'hip activity', 'hip function and activity, duration of walking with and without crutches, adverse emotions, pain and the incidence of various complications', 'scores of adverse emotions, pain and complications', 'hip activity and joint function']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392806', 'cui_str': 'Insertion of hip prosthesis'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0392806', 'cui_str': 'Insertion of hip prosthesis'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0010397', 'cui_str': 'Crutches'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0542330', 'cui_str': 'Joint mobilization'}]",81.0,0.0303049,"There was no significant difference in Harris score between the two groups at 7 days after intervention ( P >0.05); the Harris scores of the study group were significantly higher than those of the control group ( P <0.05) at 1, 3 and 6 months after intervention.","[{'ForeName': 'Mingzhi', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': ""Operating Room, The First People's Hospital of Wenling Wenling 317500, Zhejiang Province, China.""}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': ""Nephrology Hemodialysis Room, The First People's Hospital of Wenling Wenling 317500, Zhejiang Province, China.""}]",American journal of translational research,[] 3384,33841692,Influence of anesthetic induction of propofol combined with esketamine on perioperative stress and inflammatory responses and postoperative cognition of elderly surgical patients.,"OBJECTIVE To analyze the influence of anesthetic induction of propofol combined with esketamine on perioperative stress and inflammatory responses and postoperative cognition in elderly surgical patients. METHODS A total of 80 elderly surgical patients were randomly divided into a control group (n=40) and a study group (n=40). The control group received anesthetic induction with propofol combined with sufentanil, while the study group received anesthetic induction with propofol combined with esketamine. Hemodynamics, stress and inflammatory responses and changes in cognitive function, perioperative related indexes and adverse responses were compared between the two groups. RESULTS At T 1 , the levels of adrenaline, norepinephrine, endothelin, C-reactive protein, white blood cell and procalcitonin in the two groups were not markedly changed compared with those at T 0 . The levels of the indices at T 2 and T 3 were elevated compared with those at T 1 . However, the levels of the indices at T 4 were almost close to those at T 0 , and the levels in the study group were higher than those in the control group. There were statistically significant differences in the comparison of the interaction of the levels of the aforementioned indices between groups, between time points, and between groups and time points ( P < 0.05). At 24 h after surgery, the Montreal Cognitive Assessment (MoCA) scores were decreased in both groups, and the MoCA scores in the study group were higher than those in the control group ( P < 0.05). The anesthesia time and consciousness recovery time in the study group were shorter than those in the control group ( P < 0.05). CONCLUSION The anesthetic induction of propofol combined with esketamine, exhibits a good safety profile and reliability, it can improve hemodynamics and surgical stress and inflammatory responses, shorten anesthesia time, promote the recovery of postoperative cognitive function, and cause relatively mild adverse responses.",2021,"The anesthesia time and consciousness recovery time in the study group were shorter than those in the control group ( P < 0.05). ","['80 elderly surgical patients', 'elderly surgical patients']","['propofol combined with esketamine', 'anesthetic induction with propofol combined with sufentanil']","['MoCA scores', 'Hemodynamics, stress and inflammatory responses and changes in cognitive function, perioperative related indexes and adverse responses', 'perioperative stress and inflammatory responses and postoperative cognition', 'levels of adrenaline, norepinephrine, endothelin, C-reactive protein, white blood cell and procalcitonin', 'anesthesia time and consciousness recovery time', 'levels of the indices at T 2 and T 3', 'Montreal Cognitive Assessment (MoCA) scores']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C2825616', 'cui_str': 'esketamine'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}]","[{'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0079284', 'cui_str': 'Endothelin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009791', 'cui_str': 'Consciousness related finding'}, {'cui': 'C0041014', 'cui_str': 'liothyronine'}]",80.0,0.0395254,"The anesthesia time and consciousness recovery time in the study group were shorter than those in the control group ( P < 0.05). ","[{'ForeName': 'Wencai', 'Initials': 'W', 'LastName': 'Tu', 'Affiliation': ""Department of Anesthesiology, Yichun People's Hospital Yichun 336000, Jiangxi Province, China.""}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': ""Department of Anesthesiology, Yichun People's Hospital Yichun 336000, Jiangxi Province, China.""}, {'ForeName': 'Shaojin', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Yichun People's Hospital Yichun 336000, Jiangxi Province, China.""}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Lu', 'Affiliation': ""Department of Anesthesiology, Yichun People's Hospital Yichun 336000, Jiangxi Province, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yin', 'Affiliation': ""Department of Anesthesiology, Yichun People's Hospital Yichun 336000, Jiangxi Province, China.""}, {'ForeName': 'Chuanfeng', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesiology, Yichun People's Hospital Yichun 336000, Jiangxi Province, China.""}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, Yichun People's Hospital Yichun 336000, Jiangxi Province, China.""}]",American journal of translational research,[] 3385,33841679,General anesthesia versus monitored anesthesia care during endovascular therapy for vertebrobasilar stroke.,"OBJECTIVE The objective is to compare the effect of general anesthesia (GA) and monitored anesthesia care (MAC) on clinical outcomes in patients with endovascular therapy for vertebrobasilar occlusion stroke. METHODS 139 patients undergoing endovascular therapy for vertebrobasilar stroke, were recruited. The patients were randomized into GA group and MAC group (about 1:1 ratio). GA group received general anesthesia and MAC group received monitored anesthesia care during endovascular therapy. The primary outcome measure was the shift in the degree of disability among the 2 groups as measured by the modified Rankin scale score (mRS) at 90 days (80-100 days). Secondary end points included infarct volume and related complications. RESULTS The patients were assigned randomly (about 1:1 allocation) to GA group (n=72) and MAC group (n=67). The primary outcome of functional independence measured by 90-day mRS score was not significantly different between the 2 groups (median (IQR), 2 (1-3) vs. 3 (1-4); P=0.316). Final infarct volume was smaller in the GA group than in the MAC group (median (IQR), 27.60 (13.75-83.52) vs. 33.60 (26.85-92.95); P=0.045). There were no differences with statistical significance in rates of successful reperfusion (modified Thrombolysis in Cerebral Ischemia (mTICI) 2b-3) between 2 groups (73.61% vs. 76.12%; P=0.734). Early neurological outcomes measured by the 24-hour National Institutes of Health Stroke Scale scores (NIHSS) showed that 11 (interquartile range (IQR), 3-22) in GA group and 11 (interquartile range (IQR), 7-25) in MAC group, but were not statistically significant. There was no statistical difference in postoperative complications between the two groups. CONCLUSION For patients who underwent endovascular therapy for vertebrobasilar occlusion strok caused by occlusions in the posterior circulation, MAC appears to be as effective as GA. However, MAC is associated with bigger final infarct volume. Future studies are warranted to confirm our findings.",2021,There were no differences with statistical significance in rates of successful reperfusion (modified Thrombolysis in Cerebral Ischemia (mTICI) 2b-3) between 2 groups (73.61% vs. 76.12%; P=0.734).,"['139 patients undergoing endovascular therapy for vertebrobasilar stroke, were recruited', 'patients with endovascular therapy for vertebrobasilar occlusion stroke', 'vertebrobasilar stroke']","['general anesthesia and MAC group received monitored anesthesia care during endovascular therapy', 'General anesthesia versus monitored anesthesia care', 'endovascular therapy', 'MAC', 'general anesthesia (GA) and monitored anesthesia care (MAC', 'GA']","['functional independence measured by 90-day mRS score', 'posterior circulation', 'infarct volume and related complications', 'postoperative complications', 'rates of successful reperfusion (modified Thrombolysis in Cerebral Ischemia (mTICI) 2b-3', '24-hour National Institutes of Health Stroke Scale scores (NIHSS', 'modified Rankin scale score (mRS', 'Final infarct volume', 'shift in the degree of disability']","[{'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4761237', 'cui_str': 'Vertebrobasilar stroke'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",139.0,0.0659387,There were no differences with statistical significance in rates of successful reperfusion (modified Thrombolysis in Cerebral Ischemia (mTICI) 2b-3) between 2 groups (73.61% vs. 76.12%; P=0.734).,"[{'ForeName': 'Guangjun', 'Initials': 'G', 'LastName': 'Hu', 'Affiliation': 'The First Clinical College of Southern Medical University Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': 'Department of Pain Treatment, Hubei Provincial Hospital of Traditional Chinese Medicine Wuhan, Hubei Province, China.'}, {'ForeName': 'Bixi', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, General Hospital of The Central Theater Command of The Chinese PLA Wuhan, Hubei Province, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Shao', 'Affiliation': 'Department of Anesthesiology, General Hospital of The Southern Theater Command of The Chinese PLA Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'The First Clinical College of Southern Medical University Guangzhou, Guangdong Province, China.'}]",American journal of translational research,[] 3386,33841615,Comparative Evaluation of the Therapeutic Efficacy and Safety of Injected Histaglobulin versus Autologous Serum Therapy in Chronic Urticaria.,"BACKGROUND: Urticaria affects 0.5 to 1 percent of the population at any given time. Treatments include nonsedative antihistamines, autologous serum therapy, and injected histaglobulin. OBJECTIVE: This study sought to compare the therapeutic efficacy and safety of injected histaglobulin with autologous serum therapy in chronic urticaria. METHODS: This was a hospital-based prospective study performed in the Department of Dermatology, Venereology, and Leprology at Guru Gobind Singh Medical College and Hospital in Faridkot, India. A total of 96 patients with chronic idiopathic urticaria were enrolled after applying inclusion and exclusion criteria and were divided into two groups of 48 patients each using an envelope method. Autologous serum skin tests were performed in each patient irrespective of their group assignment. Group A then received injected histaglobulin and Group B received autologous serum therapy (AST). Patient were evaluated using the Urticaria Activity Score (UAS) every week for six weeks, with follow-up conducted at three and six weeks after the completion of treatment. The Chronic Urticaria Quality of Life questionnaire was used to assess the quality of life of the study participants. RESULTS: Out of the 96 initially enrolled patients, 62 completed the six weeks of treatment and two follow-up visits. Twenty patients dropped out due to remission and 14 patients left the study for other reasons. Reductions in UAS values occurred in both the groups by the end of follow-up but were more significant in Group A. Improvement in quality of life scores was also greater in Group A. Recurrence occurred in both groups after treatment cessation but was less common in Group A. CONCLUSION: Both treatments were validated for treating chronic urticaria; however, injected histaglobulin showed statistically more consequential results than AST.",2021,"Reductions in UAS values occurred in both the groups by the end of follow-up but were more significant in Group A. Improvement in quality of life scores was also greater in Group A. Recurrence occurred in both groups after treatment cessation but was less common in Group A. CONCLUSION: Both treatments were validated for treating chronic urticaria; however, injected histaglobulin showed statistically more consequential results than AST.","['Twenty patients dropped out due to remission and 14 patients left the study for other reasons', 'hospital-based prospective study performed in the Department of Dermatology, Venereology, and Leprology at Guru Gobind Singh Medical College and Hospital in Faridkot, India', '96 initially enrolled patients, 62 completed the six weeks of treatment and two follow-up visits', '96 patients with chronic idiopathic urticaria were enrolled after applying inclusion and exclusion criteria and were divided into two groups of 48 patients each using an envelope method', 'Chronic Urticaria', 'chronic urticaria']","['injected histaglobulin and Group B received autologous serum therapy (AST', 'injected histaglobulin with autologous serum therapy', 'Injected Histaglobulin versus Autologous Serum Therapy', 'nonsedative antihistamines, autologous serum therapy, and injected histaglobulin']","['Autologous serum skin tests', 'quality of life', 'Chronic Urticaria Quality of Life questionnaire', 'quality of life scores', 'therapeutic efficacy and safety', 'Urticaria Activity Score (UAS', 'UAS values']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0042467', 'cui_str': 'Venereology'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0578870', 'cui_str': 'Chronic idiopathic urticaria'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0263338', 'cui_str': 'Chronic urticaria'}]","[{'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0062738', 'cui_str': 'histaglobulin'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0242348', 'cui_str': 'Serotherapy'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0037296', 'cui_str': 'Hypersensitivity skin testing'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0263338', 'cui_str': 'Chronic urticaria'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042109', 'cui_str': 'Urticaria'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",96.0,0.00550085,"Reductions in UAS values occurred in both the groups by the end of follow-up but were more significant in Group A. Improvement in quality of life scores was also greater in Group A. Recurrence occurred in both groups after treatment cessation but was less common in Group A. CONCLUSION: Both treatments were validated for treating chronic urticaria; however, injected histaglobulin showed statistically more consequential results than AST.","[{'ForeName': 'Sumir', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'All authors are with the Department of Dermatology, Venereology, and Leprology at Guru Gobind Singh Medical College and Hospital in Faridkot, Punjab, India.'}, {'ForeName': 'Simranjeet Singh', 'Initials': 'SS', 'LastName': 'Dhillon', 'Affiliation': 'All authors are with the Department of Dermatology, Venereology, and Leprology at Guru Gobind Singh Medical College and Hospital in Faridkot, Punjab, India.'}, {'ForeName': 'B K', 'Initials': 'BK', 'LastName': 'Brar', 'Affiliation': 'All authors are with the Department of Dermatology, Venereology, and Leprology at Guru Gobind Singh Medical College and Hospital in Faridkot, Punjab, India.'}, {'ForeName': 'Amarbir', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'All authors are with the Department of Dermatology, Venereology, and Leprology at Guru Gobind Singh Medical College and Hospital in Faridkot, Punjab, India.'}]",The Journal of clinical and aesthetic dermatology,[] 3387,33841611,Treatment of Small Keloids Using Intralesional 5-fluorouracil and Triamcinolone Acetonide versus Intralesional Bleomycin and Triamcinolone Acetonide.,"BACKGROUND: The aberration of wound healing leads to scar formation in the form of hypertrophic scars and keloids. Various modalities with variable results have been used in the treatment of keloids. OBJECTIVE: We sought to evaluate outcomes in the treatment of small keloids with the combination of intralesional 5-fluorouracil (5-FU) and triamcinolone acetonide versus intralesional bleomycin and triamcinolone acetonide. DESIGN: Sixty clinically diagnosed keloid lesions in 40 patients aged 18 to 60 years were divided equally into Groups A (n=30) and B (n=30). The combination of intralesional 5-FU and triamcinolone acetonide (TAC) was given to Group A and the combination of intralesional bleomycin and triamcinolone acetonide was given to Group B. Treatment was repeated in both groups at three-week intervals until keloid flattening was achieved or a maximum of 10 treatments were completed. Before treatment, the lesions were assessed using the Vancouver Scar Scale and their size was measured using vernier calipers. RESULTS: In Group A, 15 (50%) keloids showed an excellent response, 10 (33.33%) keloids showed a good response, three (10%) keloids showed a fair response, and two (6.66%) keloids showed a poor response. In Group B, 23 (76%) keloids showed an excellent response, three (10%) keloids showed a good response, two (6.66%) keloids showed a fair response, and two (6.66%) keloids showed a poor response. CONCLUSION: Patient response regarding treatment duration, flattening of lesions, improvements in the Vancouver Scar Scale score, and recurrence rates were statistically significant in Group B. A greater improvement in the signs and symptoms of keloids (with respect to cosmetic problems, restriction of movement, and tenderness) was observed in the patients treated with a combination of intralesional bleomycin and triamcinolone acetonide compared to those treated with a combination of intralesional 5-FU and triamcinolone acetonide.",2021,"recurrence rates were statistically significant in Group B. A greater improvement in the signs and symptoms of keloids (with respect to cosmetic problems, restriction of movement, and tenderness) was observed in the patients treated with a combination of intralesional bleomycin and triamcinolone acetonide compared to those treated with a combination of intralesional 5-FU and triamcinolone acetonide.",['40 patients aged 18 to 60 years'],"['intralesional 5-FU and triamcinolone acetonide (TAC', 'intralesional bleomycin', 'intralesional 5-fluorouracil (5-FU', 'triamcinolone acetonide', 'triamcinolone acetonide versus intralesional bleomycin and triamcinolone acetonide', 'intralesional 5-FU and triamcinolone acetonide', 'intralesional bleomycin and triamcinolone acetonide', 'Intralesional 5-fluorouracil and Triamcinolone Acetonide versus Intralesional Bleomycin and Triamcinolone Acetonide']","['cosmetic problems, restriction of movement, and tenderness', 'recurrence rates', 'Vancouver Scar Scale score', 'Vancouver Scar Scale and their size']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1512955', 'cui_str': 'Intralesional route'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0005740', 'cui_str': 'Bleomycin'}]","[{'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0557989', 'cui_str': 'Restriction of movement'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",40.0,0.01866,"recurrence rates were statistically significant in Group B. A greater improvement in the signs and symptoms of keloids (with respect to cosmetic problems, restriction of movement, and tenderness) was observed in the patients treated with a combination of intralesional bleomycin and triamcinolone acetonide compared to those treated with a combination of intralesional 5-FU and triamcinolone acetonide.","[{'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Drs. Sharma and Vinay are with the Department of Dermatology, Venereology, and Leprosy at the Sri Guru Ram Das Institute of Medical Sciences & Research in Amritsar, Punjab, India.'}, {'ForeName': 'Kajal', 'Initials': 'K', 'LastName': 'Vinay', 'Affiliation': 'Drs. Sharma and Vinay are with the Department of Dermatology, Venereology, and Leprosy at the Sri Guru Ram Das Institute of Medical Sciences & Research in Amritsar, Punjab, India.'}, {'ForeName': 'Roopam', 'Initials': 'R', 'LastName': 'Bassi', 'Affiliation': 'Drs. Sharma and Vinay are with the Department of Dermatology, Venereology, and Leprosy at the Sri Guru Ram Das Institute of Medical Sciences & Research in Amritsar, Punjab, India.'}]",The Journal of clinical and aesthetic dermatology,[] 3388,33841540,Evaluating the Effect of Dexmedetomidine on Hemodynamic Status of Patients with Septic Shock Admitted to Intensive Care Unit: A Single-Blind Randomized Controlled Trial.,"Septic shock, known as the most severe complication of sepsis, is a serious medical condition that can lead to death. Clinical symptoms of sepsis include changes in body temperature in the form of hypothermia or hyperthermia, tachypnea or hyperventilation, tachycardia, leukocytosis or leukopenia, and variations in blood pressure, as well as altered state of consciousness. One of the main problems in septic shock is poor response along with reduced vascular reactivity to vasopressors used to increase blood pressure. Therefore, low vascular response associated with reduced sensitivity or lower number of alpha-1 agonist receptors can result in shock and death. In addition to being the state-of-the-art treatment including volume load and vasopressor, use of alpha-2 agonists e.g . dexmedetomidine (DXM) in septic shock can reduce vasopressors needed to restore adequate blood pressure. They can further moderate massive release of endogenous catecholamine. Therefore, the purpose of this study was to investigate the effect of DXM on outcomes of patients with septic shock, especially their needs for vasopressors and impacts on their hemodynamic status. This single-blind randomized controlled trial was performed on a total number of 66 patients with septic shock admitted to the intensive care unit (ICU) of Imam Khomeini Teaching Hospital in the city of Sari, in northern Iran. To this end, DXM (0.6 µg/kg/h) and normal saline (6 mL/kg/h) were infused for 12 h in the study and control groups, respectively. The results revealed that DXM could increase mean arterial pressure (MAP) ( P = 0.021), systolic blood pressure (SBP) ( P = 0.002), and reduced heart rate ( P < 0.001) but diastolic blood pressure (DBP) ( P =0.32) and norepinephrine dose requirement didn't change statistically in septic shock patients ( P = 0.12).",2020,"The results revealed that DXM could increase mean arterial pressure (MAP) ( P = 0.021), systolic blood pressure (SBP) ( P = 0.002), and reduced heart rate ( P < 0.001) but diastolic blood pressure (DBP) ( P =0.32) and norepinephrine dose requirement didn't change statistically in septic shock patients ( P = 0.12).","['patients with septic shock', 'Patients with Septic Shock Admitted to Intensive Care Unit', '66 patients with septic shock admitted to the intensive care unit (ICU) of Imam Khomeini Teaching Hospital in the city of Sari, in northern Iran']","['Dexmedetomidine', 'DXM', 'dexmedetomidine (DXM', 'normal saline']","['blood pressure', 'reduced heart rate', 'systolic blood pressure (SBP', 'tachypnea or hyperventilation, tachycardia, leukocytosis or leukopenia, and variations in blood pressure', 'mean arterial pressure (MAP', 'Hemodynamic Status', 'diastolic blood pressure (DBP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0443055', 'cui_str': 'Sari - microbial strain'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0020578', 'cui_str': 'Hyperventilation'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0023518', 'cui_str': 'Leukocytosis'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",66.0,0.264443,"The results revealed that DXM could increase mean arterial pressure (MAP) ( P = 0.021), systolic blood pressure (SBP) ( P = 0.002), and reduced heart rate ( P < 0.001) but diastolic blood pressure (DBP) ( P =0.32) and norepinephrine dose requirement didn't change statistically in septic shock patients ( P = 0.12).","[{'ForeName': 'Shayesteh', 'Initials': 'S', 'LastName': 'Gheibi', 'Affiliation': 'Department of Pharmacotherapy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Ala', 'Affiliation': 'Department of Pharmacotherapy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Heydari', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Imam Khomeini Hospital, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Salehifar', 'Affiliation': 'Pharmaceutical Science Research Center, Hemoglobinopathy institute, Sari, Iran.'}, {'ForeName': 'Hamideh', 'Initials': 'H', 'LastName': 'Abbaspour Kasgari', 'Affiliation': 'Department of Clinical pharmacy, Antimicrobial Resistance Research Center, Ghaemshahr Razi hospital, Mazandaran University of Medical Science,sari,Iran.'}, {'ForeName': 'Siavash', 'Initials': 'S', 'LastName': 'Moradi', 'Affiliation': 'Directr of Medical Education Development Center, School of Medicine,\xa0Mazandaran University of Medical Sciences, Sari, Iran.'}]",Iranian journal of pharmaceutical research : IJPR,['10.22037/ijpr.2019.112343.13699'] 3389,33841527,Buccal Buspirone as add-on Therapy to Omeprazole Versus Omeprazole in Treatment of Gastroesophageal Reflux Diseases (GERD).,"Proton pump inhibitors (PPIs) are recommended as first line treatments for gastroesophageal reflux disease (GERD). Failure to PPIs has been mentioned as a problem in pharmacotherapy of GERD. The present study compared the symptom relief, quality of life (QoL) and adverse drug reactions (ADRs) of omeprazole plus buccal buspirone with that of omeprazole alone.This was a prospective, randomized trial between buccal buspirone (10 mg/d) plus omeprazole (20 mg/d) and omeprazole (20 mg/d) plus placebo administered for 4 weeks to patients with GERD symptoms. Patients who had GERD symptoms enrolled in this study. 67 patients were randomly assigned to either the buspirone plus omeprazole group (n = 33) or the placebo plus omeprazole group (n = 34). Finally, 58 patients completed the study (29 in each group). Treatment response rates in each drug group were evaluated according to the Frequency Scale for the Symptoms of GERD (FFSG). The QoL and ADRs have been also evaluated too.The treatment score rates for symptom relief according to the FFSG were 7.13 ± 5.13 in the buspirone group and 15.34 ± 8.17 in the placebo group. Regarding FFSG score, there is a significant difference between the groups ( p < 0.0001). QoL were 6.86 ± 6.65 and 27.2 ± 20.95 in placebo and buspirone group, respectively after four weeks and there is a significant difference in two groups ( p < 0.0001).The total incidence of ADRs were similar in the buspirone and placebo groups ( p = 0.36).A combination of buccal buspirone plus omeprazole may be a more effective treatment for GERD than omeprazole alone.",2020,Treatment response rates in each drug group were evaluated according to the Frequency Scale for the Symptoms of GERD (FFSG).,"['67 patients', 'gastroesophageal reflux disease (GERD', 'patients with GERD symptoms', '58 patients completed the study (29 in each group', 'Patients who had GERD symptoms enrolled in this study', 'Gastroesophageal Reflux Diseases (GERD']","['Proton pump inhibitors (PPIs', 'placebo plus omeprazole', 'buspirone', 'Omeprazole Versus Omeprazole', 'buccal buspirone', 'placebo', 'omeprazole', 'buspirone plus omeprazole', 'Buccal Buspirone']","['total incidence of ADRs', 'Treatment response rates', 'Frequency Scale for the Symptoms of GERD (FFSG', 'symptom relief, quality of life (QoL) and adverse drug reactions (ADRs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C0006462', 'cui_str': 'Buspirone'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",67.0,0.0221545,Treatment response rates in each drug group were evaluated according to the Frequency Scale for the Symptoms of GERD (FFSG).,"[{'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Abdi', 'Affiliation': 'Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Sargashteh', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Abbasinazari', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Jamshid', 'Initials': 'J', 'LastName': 'Salamzadeh', 'Affiliation': 'Food Safety Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Alireza', 'Initials': 'SA', 'LastName': 'Mortazavi', 'Affiliation': 'Department of Pharmaceutics, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Iranian journal of pharmaceutical research : IJPR,['10.22037/ijpr.2020.113320.14231'] 3390,33836711,"Is the ""Brainwork Intervention"" effective in reducing sick leave for non-permanent workers with psychological problems? Results of a controlled clinical trial.","BACKGROUND Both the presence of psychological problems and the absence of an employment contract are related to long-term sickness absence, prolonged work disability and unemployment. Studies researching the effectiveness of return-to-work interventions on these non-permanent workers, including unemployed and temporary agency workers and workers with an expired fixed-term contract, are lagging behind. Therefore, a return-to-work intervention called ""Brainwork"" was developed. The aim of this study was to assess the effectiveness of the 'Brainwork Intervention' in reducing the duration of sick leave compared to usual care over a 12-month follow-up. METHODS In a multicenter controlled clinical trial, using a quasi-randomization procedure, we compared the Brainwork Intervention (n = 164) to usual care (n = 156). The primary outcome was the duration of sick leave. Secondary outcomes were the duration of sick leave starting from Social Security Agency transfer; the proportion of workers returned to work; the number of hours of paid employment during the follow-up period; the degree of worker participation; the level of psychological complaints; and the self-efficacy for return to work. Protocol adherence (Brainwork Intervention) was considered sufficient when at least three of the five protocol steps were followed. Cox regressions, linear and ordinal regression, and Mixed Model analyses were performed. RESULTS All 320 participants were analyzed. The Brainwork Intervention resulted in a non-significant reduction of the duration of sick leave compared to usual care (269 days versus 296 days; HR = 1.29; 95% CI 0.94-1.76; p = 0.11). For those working (46%) during the 12-month follow-up, the mean number of hours of paid employment was non-significantly higher in the usual care group (682 h versus 493 h; p = 0.053). No significant differences were found for other secondary outcomes. Protocol adherence was 10%. CONCLUSIONS The Brainwork Intervention as performed with a low protocol adherence did not result in a significant reduction of the duration of sick leave compared to usual care. It remains unclear what the results would have been if the Brainwork Intervention had been executed according to protocol. TRIAL REGISTRATION The Netherlands Trial Register (NTR); NTR3976 (old registration number NTR4190). Registered September 27th 2013.",2021,The Brainwork Intervention resulted in a non-significant reduction of the duration of sick leave compared to usual care (269 days versus 296 days; HR = 1.29; 95% CI 0.94-1.76; p = 0.11).,['All 320 participants were analyzed'],"['Brainwork Intervention', 'Brainwork Intervention (n\u2009=\u2009164) to usual care']","['mean number of hours of paid employment', 'duration of sick leave', 'Protocol adherence', 'duration of sick leave starting from Social Security Agency transfer; the proportion of workers returned to work; the number of hours of paid employment during the follow-up period; the degree of worker participation; the level of psychological complaints; and the self-efficacy for return to work']","[{'cui': 'C4517711', 'cui_str': '320'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C1320371', 'cui_str': 'In paid employment'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0037435', 'cui_str': 'Social Insurance'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4505269', 'cui_str': 'Worker Participation'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",320.0,0.0562451,The Brainwork Intervention resulted in a non-significant reduction of the duration of sick leave compared to usual care (269 days versus 296 days; HR = 1.29; 95% CI 0.94-1.76; p = 0.11).,"[{'ForeName': 'Selwin S', 'Initials': 'SS', 'LastName': 'Audhoe', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Coronel Institute of Occupational Health/Research Center for Insurance Medicine, Amsterdam Public Health research institute, PO Box 22700, 1100 DE, Amsterdam, The Netherlands.'}, {'ForeName': 'Jan L', 'Initials': 'JL', 'LastName': 'Hoving', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Coronel Institute of Occupational Health/Research Center for Insurance Medicine, Amsterdam Public Health research institute, PO Box 22700, 1100 DE, Amsterdam, The Netherlands.'}, {'ForeName': 'Bonne J H', 'Initials': 'BJH', 'LastName': 'Zijlstra', 'Affiliation': 'Faculty of Behavioral and Social Sciences, University of Amsterdam, Research Institute of Child Development and Education, Amsterdam, The Netherlands.'}, {'ForeName': 'Monique H W', 'Initials': 'MHW', 'LastName': 'Frings-Dresen', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Coronel Institute of Occupational Health/Research Center for Insurance Medicine, Amsterdam Public Health research institute, PO Box 22700, 1100 DE, Amsterdam, The Netherlands.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Nieuwenhuijsen', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Coronel Institute of Occupational Health/Research Center for Insurance Medicine, Amsterdam Public Health research institute, PO Box 22700, 1100 DE, Amsterdam, The Netherlands. k.nieuwenhuijsen@amsterdamumc.nl.'}]",BMC public health,['10.1186/s12889-021-10704-0'] 3391,33836708,"Targeting human milk fortification to improve very preterm infant growth and brain development: study protocol for Nourish, a single-center randomized, controlled clinical trial.","BACKGROUND Human milk is recommended for very preterm infants, but its variable macronutrient content may contribute to undernutrition during a critical period in development. We hypothesize that individually targeted human milk fortification is more effective in meeting macronutrient requirements than the current standard of care. METHODS We designed a single-center randomized, controlled trial enrolling 130 infants born < 31 completed weeks' gestation. Participants will receive fortified maternal and/or pasteurized donor milk but no formula. For participants in the intervention group, milk will be individually fortified with protein and fat modulars to achieve target levels based on daily point-of-care milk analysis with mid-infrared spectroscopy, in addition to standard fortification. The study diet will continue through 36 weeks' postmenstrual age (PMA). Clinical staff and parents will be masked to study group. Primary outcomes include: 1) body length and lean body mass by air displacement plethysmography at 36 weeks' PMA; 2) quantitative magnetic resonance imaging-based measures of brain size and microstructure at term equivalent age; and 3) Bayley-IV scales at 2 years' corrected age. DISCUSSION We expect this trial to provide important data regarding the effectiveness of individually targeted human milk fortification in the neonatal intensive care unit (NICU). TRIAL REGISTRATION NCT03977259 , registered 6 June, 2019.",2021,"We expect this trial to provide important data regarding the effectiveness of individually targeted human milk fortification in the neonatal intensive care unit (NICU). ","['very preterm infants', ""130 infants born <\u200931 completed weeks' gestation""]",['fortified maternal and/or pasteurized donor milk but no formula'],"["" 1) body length and lean body mass by air displacement plethysmography at 36\u2009weeks' PMA; 2) quantitative magnetic resonance imaging-based measures of brain size and microstructure at term equivalent age; and 3) Bayley-IV scales""]","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]","[{'cui': 'C0221097', 'cui_str': 'Length of body'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0032221', 'cui_str': 'Plethysmography'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039654', 'cui_str': '12-O-Tetradecanoyl Phorbol 13-Acetate'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",130.0,0.224099,"We expect this trial to provide important data regarding the effectiveness of individually targeted human milk fortification in the neonatal intensive care unit (NICU). ","[{'ForeName': 'Mandy B', 'Initials': 'MB', 'LastName': 'Belfort', 'Affiliation': ""Department of Pediatric Newborn Medicine, Brigham and Women's Hospital, 221 Longwood Avenue, BL-341, Boston, MA, 02115, USA. mbelfort@bwh.harvard.edu.""}, {'ForeName': 'Lianne J', 'Initials': 'LJ', 'LastName': 'Woodward', 'Affiliation': 'School of Health Sciences and Child Wellbeing Research Institute, University of Canterbury, Christchurch, New Zealand.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Cherkerzian', 'Affiliation': ""Department of Pediatric Newborn Medicine, Brigham and Women's Hospital, 221 Longwood Avenue, BL-341, Boston, MA, 02115, USA.""}, {'ForeName': 'Hunter', 'Initials': 'H', 'LastName': 'Pepin', 'Affiliation': ""Department of Pediatric Newborn Medicine, Brigham and Women's Hospital, 221 Longwood Avenue, BL-341, Boston, MA, 02115, USA.""}, {'ForeName': 'Deirdre', 'Initials': 'D', 'LastName': 'Ellard', 'Affiliation': ""Department of Pediatric Newborn Medicine, Brigham and Women's Hospital, 221 Longwood Avenue, BL-341, Boston, MA, 02115, USA.""}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Steele', 'Affiliation': ""Department of Pediatric Newborn Medicine, Brigham and Women's Hospital, 221 Longwood Avenue, BL-341, Boston, MA, 02115, USA.""}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Fusch', 'Affiliation': 'Department of Pediatrics, Paracelsus Medical School, Nuremberg, Germany.'}, {'ForeName': 'P Ellen', 'Initials': 'PE', 'LastName': 'Grant', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Terrie E', 'Initials': 'TE', 'LastName': 'Inder', 'Affiliation': ""Department of Pediatric Newborn Medicine, Brigham and Women's Hospital, 221 Longwood Avenue, BL-341, Boston, MA, 02115, USA.""}]",BMC pediatrics,['10.1186/s12887-021-02635-x'] 3392,33836690,"The CErebro Placental RAtio as indicator for delivery following perception of reduced fetal movements, protocol for an international cluster randomised clinical trial; the CEPRA study.","BACKGROUND Routine assessment in (near) term pregnancy is often inaccurate for the identification of fetuses who are mild to moderately compromised due to placental insufficiency and are at risk of adverse outcomes, especially when fetal size is seemingly within normal range for gestational age. Although biometric measurements and cardiotocography are frequently used, it is known that these techniques have low sensitivity and specificity. In clinical practice this diagnostic uncertainty results in considerable 'over treatment' of women with healthy fetuses whilst truly compromised fetuses remain unidentified. The CPR is the ratio of the umbilical artery pulsatility index over the middle cerebral artery pulsatility index. A low CPR reflects fetal redistribution and is thought to be indicative of placental insufficiency independent of actual fetal size, and a marker of adverse outcomes. Its utility as an indicator for delivery in women with reduced fetal movements (RFM) is unknown. The aim of this study is to assess whether expedited delivery of women with RFM identified as high risk on the basis of a low CPR improves neonatal outcomes. Secondary aims include childhood outcomes, maternal obstetric outcomes, and the predictive value of biomarkers for adverse outcomes. METHODS International multicentre cluster randomised trial of women with singleton pregnancies with RFM at term, randomised to either an open or concealed arm. Only women with an estimated fetal weight ≥ 10th centile, a fetus in cephalic presentation and normal cardiotocograph are eligible and after informed consent the CPR will be measured. Expedited delivery is recommended in women with a low CPR in the open arm. Women in the concealed arm will not have their CPR results revealed and will receive routine clinical care. The intended sample size based on the primary outcome is 2160 patients. The primary outcome is a composite of: stillbirth, neonatal mortality, Apgar score < 7 at 5 min, cord pH < 7.10, emergency delivery for fetal distress, and severe neonatal morbidity. DISCUSSION The CEPRA trial will identify whether the CPR is a good indicator for delivery in women with perceived reduced fetal movements. TRIAL REGISTRATION Dutch trial registry (NTR), trial NL7557 . Registered 25 February 2019.",2021,"BACKGROUND Routine assessment in (near) term pregnancy is often inaccurate for the identification of fetuses who are mild to moderately compromised due to placental insufficiency and are at risk of adverse outcomes, especially when fetal size is seemingly within normal range for gestational age.","['women with singleton pregnancies with RFM at term', 'women with perceived reduced fetal movements', 'women with a low CPR in the open arm', 'women with RFM', 'women with reduced fetal movements (RFM', '2160 patients', 'women with healthy fetuses', 'Only women with an estimated fetal weight\u2009≥\u200910th centile, a fetus in cephalic presentation and normal cardiotocograph']",[],"['umbilical artery pulsatility index', 'composite of: stillbirth, neonatal mortality, Apgar score\u2009<\u20097 at 5\u2009min, cord pH <\u20097.10, emergency delivery for fetal distress, and severe neonatal morbidity', 'childhood outcomes, maternal obstetric outcomes, and the predictive value of biomarkers for adverse outcomes']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0235659', 'cui_str': 'Reduced fetal movement'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0751992', 'cui_str': 'Body Weight, Fetal'}, {'cui': 'C0205096', 'cui_str': 'Cephalic'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0179625', 'cui_str': 'Cardiotocograph'}]",[],"[{'cui': 'C0041632', 'cui_str': 'Structure of umbilical artery'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0015930', 'cui_str': 'Nonreassuring fetal status'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.31436,"BACKGROUND Routine assessment in (near) term pregnancy is often inaccurate for the identification of fetuses who are mild to moderately compromised due to placental insufficiency and are at risk of adverse outcomes, especially when fetal size is seemingly within normal range for gestational age.","[{'ForeName': 'Stefanie E', 'Initials': 'SE', 'LastName': 'Damhuis', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. s.e.damhuis@umcg.nl.'}, {'ForeName': 'Wessel', 'Initials': 'W', 'LastName': 'Ganzevoort', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Ruben G', 'Initials': 'RG', 'LastName': 'Duijnhoven', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'Groen', 'Affiliation': 'Department of Epidemiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Sailesh', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': ""Department of Obstetrics and Gynaecology, Mater Mothers' Hospital, Mater Research Institute, University of Queensland, Brisbane, QLD, Australia.""}, {'ForeName': 'Alexander E P', 'Initials': 'AEP', 'LastName': 'Heazell', 'Affiliation': ""Maternal and Fetal Health Research Centre, Mary's Hospital, University of Manchester and Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.""}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Khalil', 'Affiliation': ""Fetal Medicine Unit, St George's University and St George's University Hospitals NHS Foundation Trust, London, UK.""}, {'ForeName': 'Sanne J', 'Initials': 'SJ', 'LastName': 'Gordijn', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}]",BMC pregnancy and childbirth,['10.1186/s12884-021-03760-2'] 3393,33836658,"Lidocaine coinfusion alleviates vascular pain induced by hypertonic saline infusion: a randomized, placebo-controlled trial.","BACKGROUND Hypertonic saline solution has been frequently utilized in clinical practice. However, due to the nonphysiological osmolality, hypertonic saline infusion usually induces local vascular pain. We conducted this study to evaluate the effect of lidocaine coinfusion for alleviating vascular pain induced by hypertonic saline. METHODS One hundred and six patients undergoing hypertonic saline volume preloading prior to spinal anesthesia were randomly allocated to two groups of 53 each. Group L received a 1 mg/kg lidocaine bolus followed by infusion of 2 mg/kg/h through the same IV line during hypertonic saline infusion; Group C received a bolus and infusion of normal saline of equivalent volume. Visual analogue scale (VAS) scores of vascular pain were recorded every 4 min. RESULTS The vascular pain severity in Group L was significantly lower than that in Group C for each time slot (P < 0.05). The overall incidence of vascular pain during hypertonic saline infusion in Group L was 48.0%, which was significantly lower than the incidence (79.6%) in Group C (P < 0.05). CONCLUSION Lidocaine coinfusion could effectively alleviate vascular pain induced by hypertonic saline infusion. TRIAL REGISTRATION Chinese Clinical Trial Registry, number: ChiCTR1900023753 . Registered on 10 June 2019.",2021,The vascular pain severity in Group L was significantly lower than that in Group C for each time slot (P < 0.05).,"['volume preloading prior to spinal anesthesia', 'One hundred and six patients undergoing']","['Hypertonic saline solution', 'hypertonic saline', 'lidocaine coinfusion', 'placebo', 'hypertonic saline infusion; Group C received a bolus and infusion of normal saline of equivalent volume', 'hypertonic saline infusion', 'lidocaine', 'Lidocaine coinfusion', 'Lidocaine']","['overall incidence of vascular pain', 'vascular pain', 'vascular pain severity', 'local vascular pain', 'Visual analogue scale (VAS) scores of vascular pain']","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0858765', 'cui_str': 'Vascular pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",106.0,0.298952,The vascular pain severity in Group L was significantly lower than that in Group C for each time slot (P < 0.05).,"[{'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Song', 'Affiliation': ""Department of Anesthesia, The First Affiliated Hospital of Nanchang University, No.17 Yongwaizheng Street, Nanchang, Jiangxi, 330006, People's Republic of China.""}, {'ForeName': 'Shibiao', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesia, The First Affiliated Hospital of Nanchang University, No.17 Yongwaizheng Street, Nanchang, Jiangxi, 330006, People's Republic of China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesia, The First Affiliated Hospital of Nanchang University, No.17 Yongwaizheng Street, Nanchang, Jiangxi, 330006, People's Republic of China.""}, {'ForeName': 'Xiaoyun', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': ""Department of Anesthesia, The First Affiliated Hospital of Nanchang University, No.17 Yongwaizheng Street, Nanchang, Jiangxi, 330006, People's Republic of China.""}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhao', 'Affiliation': ""Department of Anesthesia, The First Affiliated Hospital of Nanchang University, No.17 Yongwaizheng Street, Nanchang, Jiangxi, 330006, People's Republic of China.""}, {'ForeName': 'Zhengyu', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': ""Department of Orthodontics, The Affiliated Stomatological Hospital of Nanchang University, No.49 Fuzhou Road, Nanchang, Jiangxi, 330008, People's Republic of China. hello67@163.com.""}]",BMC anesthesiology,['10.1186/s12871-021-01329-2'] 3394,33836651,Effect of quadratus lumborum block on postoperative cognitive function in elderly patients undergoing laparoscopic radical gastrectomy: a randomized controlled trial.,"BACKGROUND Quadratus lumborum block (QLB) is a novel and effective postoperative analgesia method for abdominal surgeries. However, whether QLB can affect early postoperative cognitive function by inhibiting surgical traumatic stress and the inflammatory response remains unclear. This study aimed to explore the effect of QLB on postoperative cognitive function in elderly patients undergoing laparoscopic radical gastrectomy. METHODS Sixty-four elderly patients who underwent laparoscopic radical gastrectomy were randomly divided into the QLB group (Q group, n = 32) and control group (C group, n = 32). The Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) were used to measure cognitive function 1 day before and 7 days after surgery. Postoperative cognitive dysfunction (POCD) was defined as a decline of ≥ 1 SD in both tests. The visual analog scale (VAS) scores 6 h (T1), 24 h (T2), and 48 h (T3) after surgery were measured. The serum levels of high mobility group box protein 1 (HMGB1), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α) were evaluated 1 day before surgery (baseline), and 1 day (day 1) and 3 days after surgery (day 3). The intraoperative remifentanil dosage, sufentanil consumption 24 h after surgery, recovery time from anesthesia, and adverse effects were also compared. RESULTS POCD was present in two patients in the QLB group and eight patients in the C group 7 days after surgery (6.7 % vs. 27.6 %, P = 0.032). The MMSE and MoCA scores were similar in both groups preoperatively, and the two scores were higher in the QLB group than in the C group 7 days after surgery (P < 0.05). The VAS scores were significantly lower in the Q group at all times after surgery (P < 0.05). Compared with the C group, the levels of HMGB1, TNF-α, and IL-6 were significantly decreased 1 and 3 days after surgery in the QLB group (P < 0.05). The remifentanil consumption intraoperatively and sufentanil 24 h postoperatively were significantly lower in the QLB group (P < 0.05). The recovery time from anesthesia was shorter in the QLB group (P < 0.05). No severe adverse effects occurred in either group. CONCLUSIONS QLB could improve postoperative cognitive function in elderly patients undergoing laparoscopic radical gastrectomy. This may be related to the suppression of the inflammatory response after surgery. TRIAL REGISTRATION Chictr.org.cn identifier ChiCTR1900027574 (Date of registry: 19/11/2019, prospectively registered).",2021,"The serum levels of high mobility group box protein 1 (HMGB1), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α) were evaluated 1 day before surgery (baseline), and 1 day (day 1) and 3 days after surgery (day 3).","['elderly patients undergoing laparoscopic radical gastrectomy', 'elderly patients undergoing', 'Sixty-four elderly patients who underwent']","['Quadratus lumborum block (QLB', 'quadratus lumborum block', 'QLB', 'Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA', 'laparoscopic radical gastrectomy']","['postoperative cognitive function', 'severe adverse effects', 'visual analog scale (VAS) scores 6\xa0h (T1), 24\xa0h (T2), and 48\xa0h (T3', 'MMSE and MoCA scores', 'VAS scores', 'Postoperative cognitive dysfunction (POCD', 'levels of HMGB1, TNF-α, and IL-6', 'recovery time from anesthesia, and adverse effects', 'recovery time from anesthesia', 'serum levels of high mobility group box protein 1 (HMGB1), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0565313', 'cui_str': 'Radical gastrectomy'}, {'cui': 'C4517839', 'cui_str': '64'}]","[{'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0565313', 'cui_str': 'Radical gastrectomy'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C4721773', 'cui_str': 'Postoperative cognitive dysfunction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019796', 'cui_str': 'HMG-1 Protein'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",64.0,0.0620619,"The serum levels of high mobility group box protein 1 (HMGB1), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α) were evaluated 1 day before surgery (baseline), and 1 day (day 1) and 3 days after surgery (day 3).","[{'ForeName': 'Manhua', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, Ningbo Medical Center Lihuili Hospital, Ningbo University, No.1111 Jiangnan Road, Zhejiang, 315040, Ningbo, China. zjmjt1@163.com.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Qi', 'Affiliation': 'Department of Anesthesiology, Ningbo Medical Center Lihuili Hospital, Ningbo University, No.1111 Jiangnan Road, Zhejiang, 315040, Ningbo, China.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Department of Anesthesiology, Ningbo Medical Center Lihuili Hospital, Ningbo University, No.1111 Jiangnan Road, Zhejiang, 315040, Ningbo, China.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Ningbo Medical Center Lihuili Hospital, Ningbo University, No.1111 Jiangnan Road, Zhejiang, 315040, Ningbo, China.'}, {'ForeName': 'Yuliu', 'Initials': 'Y', 'LastName': 'Mei', 'Affiliation': ""Department of Anesthesiology,Ningbo Beilun People's Hospital, No1288 Lushan East Road, Zhejiang, 315800, Ningbo, China.""}]",BMC geriatrics,['10.1186/s12877-021-02179-w'] 3395,33836627,"DigiKnowIt News : Educating youth about pediatric clinical trials using an interactive, multimedia educational website.","Pediatric clinical trials allow for the testing of appropriate and effective treatments for children. However, some challenges exist with recruitment. This study examined the effectiveness of DigiKnowIt News , an interactive, multimedia website (which includes activities, videos, and comic books) designed to educate children about clinical trials. A randomized controlled trial was conducted in 2018 with 91 participants ( M age = 10.92 years; SD = 2.06). Participants were randomly assigned to intervention or wait-list control groups and completed questionnaires at pretest and posttest (1 week later) about their knowledge, attitudes, beliefs about clinical trials, and self-efficacy for participating in clinical trials. Participants in the intervention group received access to DigiKnowIt News between pretest and posttest and completed a satisfaction questionnaire at posttest. At the end of the study, participants in the wait-list control group were offered the option to use the website and complete a satisfaction questionnaire. At posttest, participants in the intervention group, compared to participants in the wait-list control group, had more knowledge about clinical trials and more reported confidence for participating in clinical trials. Participants reported high levels of satisfaction with DigiKnowIt News . The findings suggest that an educational website can improve factors related to increasing rates of participation in clinical trials.",2021,"At posttest, participants in the intervention group, compared to participants in the wait-list control group, had more knowledge about clinical trials and more reported confidence for participating in clinical trials.","['children', '2018 with 91 participants ( M age = 10.92\xa0years']",['intervention or wait-list control groups and completed questionnaires at pretest and posttest'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",[],,0.145875,"At posttest, participants in the intervention group, compared to participants in the wait-list control group, had more knowledge about clinical trials and more reported confidence for participating in clinical trials.","[{'ForeName': 'Alison E', 'Initials': 'AE', 'LastName': 'Parker', 'Affiliation': 'innovation Research & Training, Durham, NC, USA.'}, {'ForeName': 'Tracy M', 'Initials': 'TM', 'LastName': 'Scull', 'Affiliation': 'innovation Research & Training, Durham, NC, USA.'}, {'ForeName': 'Abigail M', 'Initials': 'AM', 'LastName': 'Morrison', 'Affiliation': 'innovation Research & Training, Durham, NC, USA.'}]",Journal of child health care : for professionals working with children in the hospital and community,['10.1177/13674935211003774'] 3396,33836405,The effect of Acupressure and Reiki application on Patient's pain and comfort level after laparoscopic cholecystectomy: A randomized controlled trial.,"BACKGROUND The aim of the study was to examine the effect of Acupressure and Reiki application on patient's pain and comfort level after Laparoscopic cholecystectomy. MATERIALS AND METHODS In this prospective, single blinded randomized controlled trial, subjects were 132 adult patients, hospitalized in the General Surgery clinics and underwent laparoscopic cholecystectomy of a Training and Research Hospital in Turkey. Subjects were then assigned including a Reiki group of 44 persons, an Acupressure group of 44 persons, and a control group of 44 persons. The pain and comfort levels of all the patients, before and after the Acupressure and Reiki treatments in the experimental group, and without any intervention in the control groups were determined at the 3rd postoperative hour, using Pain on Visual Analogue Scale (Pain on VAS), Perianesthesia Comfort Scale (PCS) and General Comfort Questionnaire (GCQ). The data analyses were performed using descriptive statistics, Shapiro Wilk test, paired samples t-test, Mann Whitney U test, ANOVA and LSD multiple comparison tests, Kruskal Wallis test and Wilcoxon test. RESULTS In the patients who received reiki and acupressure treatment, the pain level decreased, comfort level increased and the difference between the groups was found to be significant (p < 0.05). CONCLUSION Reiki and Acupressure applied to the patients after Laparoscopic cholecystectomy decreased the pain and increased the comfort level.",2021,"In the patients who received reiki and acupressure treatment, the pain level decreased, comfort level increased and the difference between the groups was found to be significant (p < 0.05). ","['group of 44 persons, and a control group of 44 persons', ""Patient's pain and comfort level after laparoscopic cholecystectomy"", 'subjects were 132 adult patients, hospitalized in the General Surgery clinics and underwent laparoscopic cholecystectomy of a Training and Research Hospital in Turkey', ""patient's pain and comfort level after Laparoscopic cholecystectomy""]","['Acupressure', 'Acupressure and Reiki application', 'Reiki and Acupressure', 'Laparoscopic cholecystectomy']","['comfort level', 'pain', 'pain and comfort levels', 'Pain on Visual Analogue Scale (Pain on VAS), Perianesthesia Comfort Scale (PCS) and General Comfort Questionnaire (GCQ', 'pain level']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0517225', 'cui_str': 'Comfort level'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C1097368', 'cui_str': 'AM132'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C3840262', 'cui_str': 'General surgery clinic'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0751715', 'cui_str': 'Reiki'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}]","[{'cui': 'C0517225', 'cui_str': 'Comfort level'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",132.0,0.052278,"In the patients who received reiki and acupressure treatment, the pain level decreased, comfort level increased and the difference between the groups was found to be significant (p < 0.05). ","[{'ForeName': 'Esra Anuş', 'Initials': 'EA', 'LastName': 'Topdemir', 'Affiliation': 'Atatürk School of Health Sciences, Dicle University,Diyarbakır, Turkey. Electronic address: esoes211@hotmail.com.'}, {'ForeName': 'Serdar', 'Initials': 'S', 'LastName': 'Saritas', 'Affiliation': 'Department of Surgical Nursing, Faculty of Nursing, Inonu University, Malatya, Turkey. Electronic address: serdar.saritas@inonu.edu.tr.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101385'] 3397,33836388,Topical ketamine as a local anesthetic agent in reducing venipuncture pain: A randomized controlled trial.,"AIM Pain control is an important aspect of ED patient management, and there are many different protocols used around the world influenced by both availability of local resources as well as staff competency and experience. This study aims to evaluate the use of topical ketamine in acute pain reduction by directly comparing it to lidocaine-prilocaine (EMLA) cream. MATERIALS AND METHODS In this randomized clinical trial, 300 adult patients classified as level 4 or 5 by ESI triage system were enrolled. These patients were divided randomly into three groups. The site of venipuncture was covered with 2 g of topical ketamine cream 10% in group one, 2 g of 5% EMLA cream in group two, and finally, in group 3 (control group), was covered with placebo (2 g of cold cream). The primary end point of the study was reported pain severity with secondary end points being onset of local anesthesia as well as any side effects noted. RESULTS The data gathered showed pain score during venipuncture in both intervention groups were significantly lower when compared to the control group (P < 0.05). However, pain score did not differ between the 2 intervention groups (P = 0.395). There was no statistically significant difference between the ketamine or EMLA in onset of local anesthesia (P = 0.419). We noted itching and irritation was significantly higher in the EMLA group when compared to ketamine(P < 0.05). CONCLUSION This study showed that local cutaneous ketamine is as effective as EMLA in relieving pain during venipuncture.",2021,There was no statistically significant difference between the ketamine or EMLA in onset of local anesthesia (P = 0.419).,['300 adult patients classified as level 4 or 5 by ESI triage system were enrolled'],"['EMLA cream', 'topical ketamine cream', 'EMLA', 'lidocaine-prilocaine (EMLA) cream', 'placebo', 'ketamine or EMLA', 'ketamine', 'topical ketamine', 'Topical ketamine']","['pain score', 'venipuncture pain', 'acute pain reduction', 'pain severity', 'itching and irritation']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0456950', 'cui_str': 'Level 4'}, {'cui': 'C0142580', 'cui_str': 'PI3 protein, human'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0360032', 'cui_str': 'EMLA Cream'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0059079', 'cui_str': 'Eutectic Mixture of Local Anesthetics'}, {'cui': 'C0617623', 'cui_str': 'Lidocaine- and prilocaine-containing product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0190979', 'cui_str': 'Phlebotomy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}]",300.0,0.120474,There was no statistically significant difference between the ketamine or EMLA in onset of local anesthesia (P = 0.419).,"[{'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Heydari', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: farhad_heidari@med.mui.ac.ir.'}, {'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Khalilian', 'Affiliation': 'Emergency Department, Alzahra University Hospital, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Keihan', 'Initials': 'K', 'LastName': 'Golshani', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Majidinejad', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Masoumi', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: bamasoumi@yahoo.com.'}, {'ForeName': 'Abaris', 'Initials': 'A', 'LastName': 'Massoumi', 'Affiliation': 'Department of General Surgery, Ealing Hospital, London North West University Healthcare NHS Trust, London, Uxbridge Road, Southall UB1 3HW, UK.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2021.03.055'] 3398,33836382,Not giving up: Testosterone promotes persistence against a stronger opponent.,"Recent research suggests that when we lack a sense of control, we are prone to motivational failures and early quitting in competitions. Testosterone, on the other hand, is thought to boost competitiveness. Here we investigate the interaction between these factors, testing the testosterone's potential to enhance persistence in a competition against a stronger opponent, depending on experimentally manipulated perceived control. Healthy participants were administered a single dose of testosterone or placebo. They first underwent a task designed to either induce low or high perceived control and then entered a costly competition against a progressively stronger opponent that they could quit at any time. In the placebo group, men with low perceived control quitted twice as early as those with high perceived control. Testosterone countered this effect, making individuals with low control persist in the competition for as long as those with high perceived control, and did so also despite raising participants' explicit awareness of the opponents' advantage. This psychoendocrinological effect was not modulated by basal cortisol levels, CAG repeat polymorphism of the androgen receptor gene, or trait dominance. Our results provide the first causal evidence that testosterone promotes competitive persistence in humans and demonstrate that this effect depends on the psychological state elicited prior to the competition, broadening our understanding of the complex relationships between testosterone and social behaviors.",2021,"This psychoendocrinological effect was not modulated by basal cortisol levels, CAG repeat polymorphism of the androgen receptor gene, or trait dominance.",['Healthy participants'],"['Testosterone', 'placebo', 'testosterone', 'testosterone or placebo']","['basal cortisol levels, CAG repeat polymorphism of the androgen receptor gene, or trait dominance']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C0034786', 'cui_str': 'Androgen receptor'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C1287621', 'cui_str': 'Eye dominance - finding'}]",,0.0670948,"This psychoendocrinological effect was not modulated by basal cortisol levels, CAG repeat polymorphism of the androgen receptor gene, or trait dominance.","[{'ForeName': 'Hana H', 'Initials': 'HH', 'LastName': 'Kutlikova', 'Affiliation': 'Neuropsychopharmacology and Biopsychology Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria; Department of Behavioural Neuroscience, Institute of Normal and Pathological Physiology, Centre of Experimental Medicine, Slovak Academy of Sciences, Sienkiewiczova 1, 813 71 Bratislava, Slovakia. Electronic address: hana.kutlikova@univie.ac.at.'}, {'ForeName': 'Shawn N', 'Initials': 'SN', 'LastName': 'Geniole', 'Affiliation': 'Neuropsychopharmacology and Biopsychology Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria; Department of Psychology, University of the Fraser Valley, 33844 King Road, Abbotsford V2S 7M8, Canada. Electronic address: shawn.geniole@ufv.ca.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Eisenegger', 'Affiliation': 'Neuropsychopharmacology and Biopsychology Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Lamm', 'Affiliation': 'Neuropsychopharmacology and Biopsychology Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria; Vienna Cognitive Science Hub, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria. Electronic address: claus.lamm@univie.ac.at.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Jocham', 'Affiliation': 'Biological Psychology of Decision Making, Institute of Experimental Psychology, Heinrich Heine University Düsseldorf, Düsseldorf, Germany. Electronic address: gerhard.jocham@hhu.de.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Studer', 'Affiliation': 'Institute of Clinical Neuroscience and Medical Psychology, Medical Faculty, Heinrich Heine University of Düsseldorf, Universitätsstraße 1, 140225 Düsseldorf, Germany; Mauritius Hospital Meerbusch, Strümper Straße 111, 40670 Meerbusch, Germany. Electronic address: bettina.studer.pastore@hhu.de.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2021.105214'] 3399,33836364,Psychoeducation for caregivers of patients with bipolar disorder-Lessons learned from a feasibility study.,"INTRODUCTION The purpose of this study was to test the feasibility and potential efficacy of a 7-week psychoeducation intervention implemented in a group setting. The intervention was based on Miklowitz's (2008) psychoeducation component of Family-Focused Therapy. METHOD This was a feasibility randomized controlled trial study using a 2-group design (intervention and wait-list control). Twelve adult family members of those with bipolar disorder were randomized to receive 7 psychoeducation sessions immediately or after a 7-week waiting period. Outcomes were caregiver burden, depression, mental-well being, health status, and cortisol and interleukin-6 (IL-6) levels. Frequencies and percentages were used to calculate feasibility measures. The Wilcoxon Signed Rank Test was used to assess change over time during treatment. RESULTS Twelve participants were recruited out of a projected sample size of 40. Feasibility rates included the following: 85% retention rate, 100% data collection rate, 94% attendance rate. The mean satisfaction score was 17.25, with potential scores of 4-20. There were trends in improvement in some of the variables (caregiver burden, mental well-being, IL-6) from pre-to post-intervention. LIMITATION The study lacked a sufficient sample size. CONCLUSION Although some feasibility results were positive and the participants were satisfied with the intervention, recruitment was challenging. The study setting was near downtown in a sprawling urban area. Also, potential participants often assume multiple role responsibilities. They often lacked the time to physically attend the sessions. Future studies could incorporate teleconference or virtual environment platforms.",2021,"There were trends in improvement in some of the variables (caregiver burden, mental well-being, IL-6) from pre-to post-intervention. ","['Twelve adult family members of those with bipolar disorder', 'caregivers of patients with bipolar disorder-Lessons', 'Twelve participants were recruited out of a projected sample size of 40']","['Psychoeducation', 'psychoeducation intervention', ""Miklowitz's (2008) psychoeducation component of Family-Focused Therapy""]","['mean satisfaction score', 'variables (caregiver burden, mental well-being, IL-6', 'feasibility and potential efficacy', 'Feasibility rates', 'caregiver burden, depression, mental-well being, health status, and cortisol and interleukin-6 (IL-6) levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}]","[{'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",12.0,0.15402,"There were trends in improvement in some of the variables (caregiver burden, mental well-being, IL-6) from pre-to post-intervention. ","[{'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Casarez', 'Affiliation': 'The University of Texas Health Science Center Cizik School of Nursing, Houston, TX, United States. Electronic address: Rebecca.L.Casarez@uth.tmc.edu.'}, {'ForeName': 'Jair C', 'Initials': 'JC', 'LastName': 'Soares', 'Affiliation': 'McGovern Medical School, Faillace Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at Houston, Houston, TX, United States.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Meyer', 'Affiliation': 'McGovern Medical School, Faillace Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at Houston, Houston, TX, United States.'}]",Journal of affective disorders,['10.1016/j.jad.2021.03.060'] 3400,33836216,Impact of altering the available food options on selection: potential mediation by social norms.,"Increasing the availability of lower-energy foods increases their selection. The current studies examine the extent to which this effect could be mediated by social norms - assessed by perceived popularity of foods - which may be implied by their relative availability. Study 1 (Online): 2340 UK adults estimated the perceived popularity of products. Participants were randomised to see photos of cafeteria shelves varying in the availability of lower-energy options ( 1 / 4 lower-energy; 1 / 2 lower-energy; 3 / 4 lower-energy) and fullness of shelves (fuller; emptier). Study 2 (Laboratory): 139 English adults were asked to select a snack. Participants were randomised to select from trays varying in the availability of the lower-energy option ( 1 / 3 lower-energy; 2 / 3 lower-energy) and fullness of tray (fuller; emptier). In Study 1, evidence for an interaction was found, such that when shelves were fuller, a higher proportion of lower-energy options led to greater perceived popularity of lower-energy products ( 1 / 4 lower-energy: 40.9% (95%CIs: 40.1,41.8); 3 / 4 lower-energy: 47.2% (46.3,48.0)), whereas when shelves were emptier, a higher proportion of lower-energy options led to lower perceived popularity ( 1 / 4 lower-energy: 48.4% (47.5,49.2); 3 / 4 lower-energy: 39.2% (38.3,40.0)). In Study 2, when the tray was fuller, participants were more likely - albeit non-significantly - to select a lower-energy snack when 2 / 3 of the available snacks were lower-energy (35.7% (18.5,52.9)) than when 1 / 3 were lower-energy (15.4% (4.2,26.5)). For emptier trays, lower-energy selections decreased as the relative availability of lower-energy snacks increased ( 1 / 3 lower-energy snacks: 36.0% (17.9,54.1); 2 / 3 lower-energy snacks: 27.8% (13.9,41.7)). These studies provide novel evidence that social norms may mediate the impact of availability on food selection. In addition, they suggest that the effect of availability may be moderated by display layout through its impact on perceived product popularity.",2021,"In Study 2, when the tray was fuller, participants were more likely - albeit non-significantly - to select a lower-energy snack when 2 / 3 of the available snacks were lower-energy (35.7% (18.5,52.9)) than when ","['2340 UK adults estimated the perceived popularity of products', '139 English adults', 'Study 2 (Laboratory']",[],"['lower-energy', 'relative availability of lower-energy snacks']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}]",139.0,0.0965776,"In Study 2, when the tray was fuller, participants were more likely - albeit non-significantly - to select a lower-energy snack when 2 / 3 of the available snacks were lower-energy (35.7% (18.5,52.9)) than when ","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Pechey', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK; Nuffield Department of Primary Care Health Sciences, University of Oxford, OX2 6GG. Electronic address: rachel.pechey@phc.ox.ac.uk.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Clarke', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Pechey', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Ventsel', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Gareth J', 'Initials': 'GJ', 'LastName': 'Hollands', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Marteau', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}]",Appetite,['10.1016/j.appet.2021.105245'] 3401,33836215,Promoting vegetable intake in preschool children: Independent and combined effects of portion size and flavor enhancement.,"This study investigated the independent and combined effects on preschool children's vegetable intake of serving a larger portion of vegetables and enhancing their flavor. In a crossover design, lunch was served in childcare centers once a week for four weeks to 67 children aged 3-5 y (26 boys, 41 girls). The meal consisted of two familiar vegetables (broccoli and corn) served with fish sticks, rice, ketchup, applesauce, and milk. Across the four meals, we varied the portion of vegetables (60 or 120 g total weight, served as equal weights of broccoli and corn) and served them either plain or enhanced (6.6% light butter and 0.5% salt by weight). All meals were consumed ad libitum and were weighed to determine intake. Doubling the portion of vegetables led to greater consumption of both broccoli and corn (both p < 0.0001) and increased meal vegetable intake by 68% (mean ± SEM 21 ± 3 g). Enhancing vegetables with butter and salt, however, did not influence their intake (p = 0.13), nor did flavor enhancement modify the effect of portion size on intake (p = 0.10). Intake of other meal components did not change when the vegetable portion was doubled (p = 0.57); thus, for the entire meal, the increase in vegetable consumption led to a 5% increase in energy intake (13 ± 5 kcal; p = 0.02). Ratings indicated that children had similar liking for the plain and enhanced versions of each vegetable (both p > 0.31). All versions of vegetables were well-liked, as indicated by ≥ 76% of the children rating them as ""yummy"" or ""just okay"". Serving a larger portion of vegetables at a meal was an effective strategy to promote vegetable intake in children, but when well-liked vegetables were served, adding butter and salt was not necessary to increase consumption.",2021,Doubling the portion of vegetables led to greater consumption of both broccoli and corn (both p<0.0001) and increased meal vegetable intake by 68% (mean±SEM 21±3 g).,"['preschool children', '67 children aged 3-5 y (26 boys, 41 girls', ""preschool children's vegetable intake of serving a larger portion of vegetables and enhancing their flavor""]","['plain or enhanced (6.6% light butter and 0.5% salt by weight', 'meal consisted of two familiar vegetables (broccoli and corn) served with fish sticks, rice, ketchup, applesauce, and milk']","['energy intake', 'vegetable consumption', 'vegetable portion', 'meal vegetable intake']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}]","[{'cui': 'C4517823', 'cui_str': '6.6'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0006494', 'cui_str': 'Butter'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0330498', 'cui_str': 'Brassica oleracea'}, {'cui': 'C0010028', 'cui_str': 'Zea mays'}, {'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C1706582', 'cui_str': 'Stick'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0453373', 'cui_str': 'Tomato sauce'}, {'cui': 'C1720240', 'cui_str': 'Applesauce'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]","[{'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake'}]",67.0,0.0277464,Doubling the portion of vegetables led to greater consumption of both broccoli and corn (both p<0.0001) and increased meal vegetable intake by 68% (mean±SEM 21±3 g).,"[{'ForeName': 'Hanim E', 'Initials': 'HE', 'LastName': 'Diktas', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Liane S', 'Initials': 'LS', 'LastName': 'Roe', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Kathleen L', 'Initials': 'KL', 'LastName': 'Keller', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA; Department of Food Science, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'Sanchez', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Rolls', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA. Electronic address: bjr4@psu.edu.'}]",Appetite,['10.1016/j.appet.2021.105250'] 3402,33835990,"Low-Molecular-Weight Heparin Combined With Insulin Versus Insulin Alone in the Treatment of Hypertriglyceridemic Pancreatitis (LIHTGP Trial): Study Protocol for a Multicenter, Prospective, Single-Blind, Randomized Controlled Trial: Retraction.",,2021,,['Hypertriglyceridemic Pancreatitis (LIHTGP Trial'],['Low-Molecular-Weight Heparin Combined With Insulin Versus Insulin Alone'],[],"[{'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]",[],,0.161724,,[],Pancreas,['10.1097/MPA.0000000000001784'] 3403,33835939,"Effects of Myo-inositol Hexaphosphate (SNF472) on Bone Mineral Density in Patients Receiving Hemodialysis: An Analysis of the Randomized, Placebo-Controlled CaLIPSO Study.","BACKGROUND AND OBJECTIVES In the CaLIPSO study, intravenous administration of SNF472 (300 or 600 mg) during hemodialysis significantly attenuated progression of coronary artery and aortic valve calcification. SNF472 selectively inhibits formation of hydroxyapatite, the final step in cardiovascular calcification. Because bone mineral is predominantly hydroxyapatite, we assessed changes in bone mineral density in CaLIPSO. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS Patients with coronary artery calcification at screening (Agatston score of 100-3500 U) were randomized 1:1:1 to receive placebo, 300 mg SNF472, or 600 mg SNF472 as an intravenous infusion during hemodialysis three times weekly for 52 weeks. Dual-energy x-ray absorptiometry (DXA) scans were obtained at baseline (screening) and end of treatment, and between-group changes from baseline were compared using analysis of covariance. RESULTS Among 274 randomized patients, 202 had evaluable DXA scans at baseline and postrandomization (the DXA-modified intention-to-treat population). Mean (95% confidence interval) changes in total-hip bone mineral density from baseline to week 52 were -1.5% (-2.7% to -0.3%), -1.5% (-2.7% to -0.4%), and -2.5% (-3.8% to -1.2%) in the placebo, 300 mg SNF472, and 600 mg SNF472 groups, respectively. Mean (95% confidence interval) changes in femoral-neck bone mineral density from baseline to week 52 were -0.3% (-1.6% to 1.0%), -1.0% (-2.3% to 0.2%), and -2.6% (-4.0% to -1.3%), respectively. Regression analyses showed no correlation between change in coronary artery calcium volume and change in bone mineral density at either location. Changes in serum alkaline phosphatase, calcium, magnesium, phosphate, and intact parathyroid hormone levels were similar across treatment groups. Clinical fracture events were reported for four of 90, three of 92, and six of 91 patients in the placebo, 300 mg SNF472, and 600 mg SNF472 groups, respectively. CONCLUSIONS Bone mineral density decreased modestly in all groups over 1 year. In the 600 mg SNF472 group, the reduction appeared more pronounced. Reported fractures were infrequent in all groups. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER Effect of SNF472 on Progression of Cardiovascular Calcification in End-Stage-Renal-Disease (ESRD) Patients on Hemodialysis (HD), NCT02966028.",2021,"Changes in serum alkaline phosphatase, calcium, magnesium, phosphate, and intact parathyroid hormone levels were similar across treatment groups.","['Patients with coronary artery calcification at screening (Agatston score of 100-3500 U', 'Patients Receiving Hemodialysis', '274 randomized patients, 202 had evaluable DXA scans at baseline and postrandomization (the DXA-modified intention-to-treat population']","['placebo, 300 mg SNF472, or 600 mg SNF472', 'Myo-inositol Hexaphosphate (SNF472', 'SNF472', 'placebo', 'Placebo']","['Bone mineral density', 'femoral-neck bone mineral density', 'coronary artery calcium volume and change in bone mineral density', 'serum alkaline phosphatase, calcium, magnesium, phosphate, and intact parathyroid hormone levels', 'Dual-energy x-ray absorptiometry (DXA) scans', 'Clinical fracture events', 'total-hip bone mineral density', 'bone mineral density', 'progression of coronary artery and aortic valve calcification', 'Bone Mineral Density']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1611184', 'cui_str': 'Calcification of coronary artery'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517736', 'cui_str': '3500'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C5198328', 'cui_str': 'SNF472'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0021547', 'cui_str': 'Inositol'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C1562777', 'cui_str': 'Calcium volume'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0036776', 'cui_str': 'Serum alkaline phosphatase measurement'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030786', 'cui_str': 'Hip Bone'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0428791', 'cui_str': 'Aortic valve calcification'}]",274.0,0.198041,"Changes in serum alkaline phosphatase, calcium, magnesium, phosphate, and intact parathyroid hormone levels were similar across treatment groups.","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Bushinsky', 'Affiliation': 'Department of Medicine, University of Rochester School of Medicine, Rochester, New York david_bushinsky@urmc.rochester.edu.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Raggi', 'Affiliation': 'Department of Medicine, Mazankowski Alberta Heart Institute and University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Bover', 'Affiliation': 'Department of Nephrology, Puigvert Foundation/Autonoma University, Sant Pau Biomedical Research Institute, Red de Investigacion Renal (REDinREN), Barcelona, Spain.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Ketteler', 'Affiliation': 'Department of General Internal Medicine and Nephrology, Robert Bosch Hospital, Stuttgart, Germany.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Bellasi', 'Affiliation': 'Research, Innovation and Brand Reputation Unit, Papa Giovanni XXIII Hospital, Bergamo, Italy.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Rodriguez', 'Affiliation': 'Nephrology Unit, Reina Sofia University Hospital, Maimonides Biomedical Research Institute of Córdoba (IMIBIC), Red de Investigacion Renal (REDinREN), Córdoba, Spain.'}, {'ForeName': 'Smeeta', 'Initials': 'S', 'LastName': 'Sinha', 'Affiliation': 'Department of Renal Medicine, Salford Royal National Health Service Foundation Trust, Salford, United Kingdom.'}, {'ForeName': 'Rekha', 'Initials': 'R', 'LastName': 'Garg', 'Affiliation': 'Research and Development, Sanifit Therapeutics, San Diego, California.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Perelló', 'Affiliation': 'Research and Development, Sanifit Therapeutics, Palma, Spain.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Gold', 'Affiliation': 'Research and Development, Sanifit Therapeutics, San Diego, California.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'Department of Medicine, Stanford University, Palo Alto, California.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.16931020'] 3404,33835936,Effectiveness of Delivering Dialectical Behavioural Therapy Techniques by E-Mail in Patients with Borderline Personality Disorder: Non-Randomized Controlled Trial.,"BACKGROUND Borderline Personality Disorder (BPD) is a debilitating and prevalent mental health disorder that has often inaccessible treatment options. Electronically Delivered Dialectical Behavioural Therapy (e-DBT) could be an efficacious and more accessible intervention. OBJECTIVE The current study aimed to evaluate the efficacy of e-DBT in the treatment of individuals with symptoms of BPD. METHODS Study participants diagnosed with BPD were offered treatment options of either email-based (e-DBT) or in-person group format of a DBT skills-building program. During each session, participants were provided with both the material and feedback regarding their previous week's homework. e-DBT protocol and content were designed to mirror in-person content. Participants were assessed by using a Self-Assessment Questionnaire (SAQ) and Difficulties in Emotion Regulation Scale (DERS). RESULTS There were significant increases in SAQ scores from pre-to post-treatment in the e-DBT group F (1,92) = 69.32, p < 0.001, and in-person group, F (1,92) = 60.97, p < .001. There were no significant differences observed between the groups at pre- and post-treatment for SAQ scores, F (1,92) = .05, p = .83. There were significant decreases in DERS scores observed between pre- and post-treatment in the e-DBT group, F (1,91) = 30.15, p < .001, and the in-person group, F (1,91) = 58.18, p < .001. There were no significant differences observed between the groups at pre- and post-treatment for DERS scores, F (1,91) = .24, p = .63. There was no significant difference in treatment efficacy observed between the two treatment arms. CONCLUSIONS Despite the proven efficacy of in-person DBT in the treatment of BPD, there are barriers to receiving this treatment. With the prevalence of internet access continuing to rise globally, delivering DBT with email may provide a more accessible alternative to treatment for individuals with BPD, without sacrificing the quality of care. CLINICALTRIAL ClinicalTrials.gov Protocol Registration System (NCT04493580); https://clinicaltrials.gov/ct2/show/NCT04493580.",2021,"There were significant decreases in DERS scores observed between pre- and post-treatment in the e-DBT group, F (1,91) =","['individuals with symptoms of BPD', 'Borderline Personality Disorder (BPD', 'Patients with Borderline Personality Disorder', 'Study participants diagnosed with BPD', 'individuals with BPD']","['email-based (e-DBT) or in-person group format of a DBT skills-building program', 'Electronically Delivered Dialectical Behavioural Therapy (e-DBT', 'Dialectical Behavioural Therapy Techniques by E-Mail', 'e-DBT']","['Self-Assessment Questionnaire (SAQ) and Difficulties in Emotion Regulation Scale (DERS', 'treatment efficacy', 'SAQ scores', 'DERS scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C3472347', 'cui_str': 'Digital breast tomosynthesis'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.100664,"There were significant decreases in DERS scores observed between pre- and post-treatment in the e-DBT group, F (1,91) =","[{'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Alavi', 'Affiliation': ""Department of Psychiatry, Queen's University, Hotel Dieu Hospital166 Brock Street, Kingston, CA.""}, {'ForeName': 'Callum', 'Initials': 'C', 'LastName': 'Stephenson', 'Affiliation': ""Department of Psychiatry, Queen's University, Hotel Dieu Hospital166 Brock Street, Kingston, CA.""}, {'ForeName': 'Margo', 'Initials': 'M', 'LastName': 'Rivera', 'Affiliation': ""Personality Disorder Services, Queen's University, Kingston, CA.""}]",JMIR mental health,['10.2196/27308'] 3405,33835933,"Correction: System Architecture for ""Support Through Mobile Messaging and Digital Health Technology for Diabetes"" (SuMMiT-D): Design and Performance in Pilot and Randomized Controlled Feasibility Studies.",[This corrects the article DOI: 10.2196/18460.].,2021,[This corrects the article DOI: 10.2196/18460.].,[],[],[],[],[],[],,0.142229,[This corrects the article DOI: 10.2196/18460.].,"[{'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Chi', 'Affiliation': 'Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Carmelo', 'Initials': 'C', 'LastName': 'Velardo', 'Affiliation': 'Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Allen', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Robinson', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Evgenia', 'Initials': 'E', 'LastName': 'Riga', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Judge', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Tarassenko', 'Affiliation': 'Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Farmer', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}]",JMIR formative research,['10.2196/29451'] 3406,33841270,Six Weeks of Basketball Combined With Mathematics in Physical Education Classes Can Improve Children's Motivation for Mathematics.,"This study investigated whether 6 weeks of basketball combined with mathematics once a week in physical education lessons could improve children's motivation for mathematics. Seven hundred fifty-seven children (mean age = 10.4 years, age range: 7-12 years) were randomly selected to have either basketball combined with mathematics once a week (BM) or to have basketball sessions without mathematics (CON). Children in BM and CON motivation for classroom-based mathematics were measured using the Academic Self-Regulation Questionnaire (SRQ-A) before (T0) and after the intervention (T1). Among the BM, levels of intrinsic motivation, feelings of competence, and autonomy were measured using the Post-Experimental Intrinsic Motivation Inventory (IMI) questionnaire acutely after a basketball session combined with mathematics and immediately after a session of classroom-based mathematics. BM had significantly higher acute levels of perceived autonomy (+14.24%, p < 0.0001), competencies (+6.33%, p < 0.0001), and intrinsic motivation (+16.09%, p < 0.0001) during basketball sessions combined with mathematics compared to when having classroom-based mathematics. A significant decrease in the mean for intrinsic motivation was observed from T0 to T1 for CON (-9.38%, p < 0.001), but not for BM (-0.39%, p = 0.98). BM had a more positive development in intrinsic motivation compared to CON from T0 to T1 ( p = 0.006), meaning that BM had a positive influence on children's intrinsic motivation for classroom-based mathematics. This study indicates that basketball combined with mathematics is an intrinsically motivating way to practice mathematics, which also has a positive influence on children's general intrinsic motivation for mathematics in the classroom.",2021,"BM had significantly higher acute levels of perceived autonomy (+14.24%, p < 0.0001), competencies (+6.33%, p < 0.0001), and intrinsic motivation (+16.09%, p < 0.0001) during basketball sessions combined with mathematics compared to when having classroom-based mathematics.","['Seven hundred fifty-seven children (mean age = 10.4 years, age range: 7-12 years']","['Basketball Combined With Mathematics in Physical Education Classes', 'basketball combined with mathematics once a week (BM) or to have basketball sessions without mathematics (CON']","[""children's motivation for mathematics"", 'Academic Self-Regulation Questionnaire (SRQ-A', 'BM, levels of intrinsic motivation, feelings of competence, and autonomy', 'acute levels of perceived autonomy', 'intrinsic motivation', 'mean for intrinsic motivation', ""children's intrinsic motivation"", 'Post-Experimental Intrinsic Motivation Inventory (IMI) questionnaire acutely']","[{'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191376', 'cui_str': '10.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392350', 'cui_str': 'Intrinsic motivation'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",757.0,0.0505311,"BM had significantly higher acute levels of perceived autonomy (+14.24%, p < 0.0001), competencies (+6.33%, p < 0.0001), and intrinsic motivation (+16.09%, p < 0.0001) during basketball sessions combined with mathematics compared to when having classroom-based mathematics.","[{'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Wienecke', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Hauge', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Nielsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Mouritzen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Linn', 'Initials': 'L', 'LastName': 'Damsgaard', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}]",Frontiers in psychology,['10.3389/fpsyg.2021.636578'] 3407,33841257,Remedial Teaching and Learning From a Cognitive Diagnostic Model Perspective: Taking the Data Distribution Characteristics as an Example.,"In response to the big data era trend, statistics has become an indispensable part of mathematics education in junior high school. In this study, a pre-test and a post-test were developed for the six attributes (sort, median, average, variance, weighted average, and mode) of the data distribution characteristic. This research then used the cognitive diagnosis model to learn about the poorly mastered attributes and to verify whether cognitive diagnosis can be used for targeted intervention to improve students' abilities effectively. One hundred two eighth graders participated in the experiment and were divided into two groups. Among them, the intervention materials read by the experimental group students only contained attributes that they could not grasp well. In contrast, the reading materials of the control group were non-targeted. The results of the study showed the following: (1) The variance and the weighted average were poorly mastered by students in the pre-test; (2) compared with the control group, the average test score of the experimental group was significantly improved; (3) in terms of attributes, the experimental group students' mastery of variance and the weighted average was significantly improved than the pre-test, while the control group's mastery was not. Based on this, some teaching suggestions were put forward.",2021,"The results of the study showed the following: (1) The variance and the weighted average were poorly mastered by students in the pre-test; (2) compared with the control group, the average test score of the experimental group was significantly improved; (3) in terms of attributes, the experimental group students' mastery of variance and the weighted average was significantly improved than the pre-test, while the control group's mastery was not.",['One hundred two eighth graders'],['Remedial Teaching and Learning'],[],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205442', 'cui_str': 'Eighth'}]","[{'cui': 'C0035051', 'cui_str': 'Remedial Teaching'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",[],102.0,0.0205165,"The results of the study showed the following: (1) The variance and the weighted average were poorly mastered by students in the pre-test; (2) compared with the control group, the average test score of the experimental group was significantly improved; (3) in terms of attributes, the experimental group students' mastery of variance and the weighted average was significantly improved than the pre-test, while the control group's mastery was not.","[{'ForeName': 'He', 'Initials': 'H', 'LastName': 'Ren', 'Affiliation': 'Collaborative Innovation Center of Assessment for Basic Education Quality, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Ningning', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'School of Statistics, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Yuxiang', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Statistics, University of California, Davis, Davis, CA, United States.'}, {'ForeName': 'Shumei', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'School of Statistics, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': 'Collaborative Innovation Center of Assessment for Basic Education Quality, Beijing Normal University, Beijing, China.'}]",Frontiers in psychology,['10.3389/fpsyg.2021.628607'] 3408,33841253,The Effect of Psychology Objective Structured Clinical Examination Scenarios Presentation Order on Students Autonomic Stress Response.,"The objective structured clinical examination (OSCE) is a method for assessment clinical competencies and skills. However, there is a need to improve its design in psychology programs. The aim of this study was to analyze the effect of the different scenario's presentation order with different complexity/difficulty on the autonomic stress response of undergraduate students undergoing a Psychology OSCE. A total of 32 students of Psychology Bachelor's Degree (23.4 ± 2.5 years) were randomly selected and assigned to two OSCE scenarios of different complexity. While undergoing the scenarios, participants heart rate variability was analyzed as an indicator of participant's stress autonomic response. Results indicate that the order of presentation of different complexity/difficulty scenarios affects the autonomic stress response of undergraduate Psychology students undergoing an OSCE. Students who underwent the high-complexity scenario (difficult) first, reported significantly higher autonomic stress response than students who began the OSCE with the low-complexity scenario (easy). Highly complex or difficult scenarios require good executive functions or cognitive control, very sensitive to autonomic stress responses. Therefore, OSCE design will benefit from placing easy scenarios first.",2021,"Students who underwent the high-complexity scenario (difficult) first, reported significantly higher autonomic stress response than students who began the OSCE with the low-complexity scenario (easy).","[""32 students of Psychology Bachelor's Degree (23.4 ± 2.5 years"", 'undergraduate students undergoing a Psychology OSCE', 'undergraduate Psychology students undergoing an OSCE', 'Students Autonomic Stress Response']",['OSCE'],"['heart rate variability', 'autonomic stress response']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0337600', 'cui_str': 'Bachelor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4517655', 'cui_str': '23.4'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",32.0,0.0283894,"Students who underwent the high-complexity scenario (difficult) first, reported significantly higher autonomic stress response than students who began the OSCE with the low-complexity scenario (easy).","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Bellido-Esteban', 'Affiliation': 'Faculty of Psychology, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Ana Isabel', 'Initials': 'AI', 'LastName': 'Beltrán-Velasco', 'Affiliation': 'Department of Education, University of Nebrija, Madrid, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Ruisoto-Palomera', 'Affiliation': 'Department of Health Sciences, Public University of Navarre, Pamplona, Spain.'}, {'ForeName': 'Pantelis T', 'Initials': 'PT', 'LastName': 'Nikolaidis', 'Affiliation': 'Department of Physical and Cultural Education, Hellenic Army Academy, Athens, Greece.'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Knechtle', 'Affiliation': 'Institute of Primary Care, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Vicente Javier', 'Initials': 'VJ', 'LastName': 'Clemente-Suárez', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain.'}]",Frontiers in psychology,['10.3389/fpsyg.2021.622102'] 3409,33841224,"Combined Chair-Based Exercises Improve Functional Fitness, Mental Well-Being, Salivary Steroid Balance, and Anti-microbial Activity in Pre-frail Older Women.","Introduction Regular exercise has long been shown to positively impact the immune system responsiveness and improve mental well-being (MWB). However, the putative links between biomarkers of mental health and immune efficiency in exercising subjects have been scarcely investigated. The aim of this study was to verify the effect of a 14-week combined chair-based exercise program (CEP) on salivary steroid hormones and anti-microbial proteins, functional fitness, and MWB indexes in pre-frail older women. Methods The participant women (82.8 4.6 years old; n = 32) were randomly divided into the exercising group (CEP, n = 17) and the non-exercising control group (CG, n = 15). The pre/post assessment included: (1) salivary anti-microbial proteins lysozyme; (Lys) and immunoglobulin-A (IgA); (2) salivary steroid hormones of testosterone (TT) and cortisol (COR); (3) functional fitness (gait speed, hand grip strength, and static balance); (4) MWB questionnaires (happiness, depression state, satisfaction with life, and stress). Results Significant differences with large Cohen's ( d ) effect sizes were found on increased salivary TT ( p < 0.05; d = 0.60) after exercise intervention. The results revealed a decrease in IgA levels after CEP ( p < 0.01, d = 0.30). The increase in subjective happiness levels ( p < 0.05, d = 0.30) and decrease of stress perception ( p < 0.01, d = 2.60) and depressive state ( p < 0.05, d = 0.30) were found after intervention in the CEP group. Robust statistical differences in gait speed ( p < 0.05; d = 0.60) and balance tests ( p < 0.05; d = 0.80) were also found in the CEP group. In control, COR increased moderately ( p < 0.05; d = 0.65) while no changes were found for the other indicators. Correlation analyses showed inter-dependence between pre-post variations of MWB, biochemical indexes, and fitness function (e.g., COR inverse correlation with hand grip strength and balance tests). Conclusion The CEP program was able to improve functional-fitness performance, decrease feelings of stress, and increase happiness. The CEP also induced clinically relevant hormonal and immune responses, which suggests that chair exercises that combine muscular strength, balance, and gait speed training are promising interventions to improve physical and mental health of older pre-frail adults.",2021,"The results revealed a decrease in IgA levels after CEP ( p < 0.01, d = 0.30).","['pre-frail older women', 'Pre-frail Older Women', 'older pre-frail adults', 'participant women (82.8 4.6 years old; n = 32']","['exercising group (CEP, n = 17) and the non-exercising control', '14-week combined chair-based exercise program (CEP', 'Combined Chair-Based Exercises', 'CEP']","['salivary steroid hormones and anti-microbial proteins, functional fitness, and MWB indexes', 'MWB, biochemical indexes, and fitness function (e.g., COR inverse correlation with hand grip strength and balance tests', 'balance tests', 'salivary TT', 'subjective happiness levels', 'salivary anti-microbial proteins lysozyme; (Lys) and immunoglobulin-A (IgA); (2) salivary steroid hormones of testosterone (TT) and cortisol (COR); (3) functional fitness (gait speed, hand grip strength, and static balance); (4) MWB questionnaires (happiness, depression state, satisfaction with life, and stress', 'depressive state', 'Functional Fitness, Mental Well-Being, Salivary Steroid Balance, and Anti-microbial Activity', 'gait speed', 'stress perception', 'IgA levels', 'functional-fitness performance, decrease feelings of stress, and increase happiness']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0301818', 'cui_str': 'Steroid hormone'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0439850', 'cui_str': 'Inverse'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026794', 'cui_str': 'Muramidase'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",32.0,0.00457342,"The results revealed a decrease in IgA levels after CEP ( p < 0.01, d = 0.30).","[{'ForeName': 'Guilherme Eustáquio', 'Initials': 'GE', 'LastName': 'Furtado', 'Affiliation': 'Research Unit in Sport and Physical Activity-CIDAF (UID/PTD/04213/2020), Faculty of Sport Sciences and Physical Education (FCDEF-UC), University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Rubens Vinícius', 'Initials': 'RV', 'LastName': 'Letieri', 'Affiliation': 'Rehabilitation Sciences Program, Federal University of Alfenas (UNIFAL), Alfenas, Brazil.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Silva-Caldo', 'Affiliation': 'Research Unit in Sport and Physical Activity-CIDAF (UID/PTD/04213/2020), Faculty of Sport Sciences and Physical Education (FCDEF-UC), University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Joice C S', 'Initials': 'JCS', 'LastName': 'Trombeta', 'Affiliation': 'Exercise Physiology Laboratory (FISEX), Faculty of Physical Education, University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Monteiro', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Federal University of São Carlos (UFscar), São Carlos, Brazil.'}, {'ForeName': 'Rafael Nogueira', 'Initials': 'RN', 'LastName': 'Rodrigues', 'Affiliation': 'Research Unit in Sport and Physical Activity-CIDAF (UID/PTD/04213/2020), Faculty of Sport Sciences and Physical Education (FCDEF-UC), University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Vieira-Pedrosa', 'Affiliation': 'Research Unit in Sport and Physical Activity-CIDAF (UID/PTD/04213/2020), Faculty of Sport Sciences and Physical Education (FCDEF-UC), University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Marcelo Paes', 'Initials': 'MP', 'LastName': 'Barros', 'Affiliation': 'Institute of Physical Activity Sciences and Sports (ICAFE), Interdisciplinary Program in Health Sciences, Cruzeiro do Sul University, São Paulo, Brazil.'}, {'ForeName': 'Cláudia Regina', 'Initials': 'CR', 'LastName': 'Cavaglieri', 'Affiliation': 'Exercise Physiology Laboratory (FISEX), Faculty of Physical Education, University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Eef', 'Initials': 'E', 'LastName': 'Hogervorst', 'Affiliation': 'Applied Cognitive Research NCSEM, Loughborough University, Loughborough, United Kingdom.'}, {'ForeName': 'Ana Maria', 'Initials': 'AM', 'LastName': 'Teixeira', 'Affiliation': 'Research Unit in Sport and Physical Activity-CIDAF (UID/PTD/04213/2020), Faculty of Sport Sciences and Physical Education (FCDEF-UC), University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'José Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': 'Research Unit in Sport and Physical Activity-CIDAF (UID/PTD/04213/2020), Faculty of Sport Sciences and Physical Education (FCDEF-UC), University of Coimbra, Coimbra, Portugal.'}]",Frontiers in psychology,['10.3389/fpsyg.2021.564490'] 3410,33841184,Absent Exercise-Induced Improvements in Fat Oxidation in Women With Polycystic Ovary Syndrome After High-Intensity Interval Training.,"Background: Polycystic ovary syndrome (PCOS) and metabolic inflexibility are linked to insulin resistance, and women with PCOS appear to be metabolic inflexible in the rested, insulin-stimulated state. Exercise training is a primary lifestyle intervention in PCOS. Exercise training improves whole-body fat oxidation during submaximal exercise in healthy women, yet little is known about the effect on this outcome in women with PCOS. Methods: We measured whole-body fat oxidation rates during sub maximal exercise before and after 16 weeks of high-intensity interval training (HIT) in women with PCOS randomly allocated to either: low- or high-volume HIT ( n = 41; low-volume HIT, 10 × 1 min work bouts at maximal, sustainable intensity and high-volume HIT, 4 × 4 min work bouts at 90-95% of maximal heart rate) or non-exercise control ( n = 23), and in women without PCOS (Non-PCOS) allocated to low- or high volume HIT ( n = 15). HIT was undertaken three times weekly. In a subset of women with and without PCOS, we measured mitochondrial respiration in abdominal and gluteal subcutaneous adipose tissue using high-resolution respirometry, as well as fat cell sizes in these tissues. Results: At baseline, women with PCOS had lower whole-body fat oxidation and mitochondrial respiration rates in abdominal adipose tissue compared to Non-PCOS. Peak oxygen uptake (mL/min/kg) increased in women with PCOS (~4%, p = 0.006) and Non-PCOS (~6%, p = 0.003) after 16 weeks of HIT. Whole-body fat oxidation only improved in Non-PCOS after HIT. No changes were observed in mitochondrial respiration and cell size in abdominal and gluteal adipose tissue after HIT in either group of women. Conclusion: We observed exercise-induced improvements in whole-body fat oxidation during submaximal exercise in Non-PCOS, but not in women with PCOS, after 16 weeks of HIT, suggesting metabolic inflexibility in women with PCOS. Clinical Trial Registration: www.clinicaltrials.gov, identifier NCT02419482 and NCT02943291.",2021,No changes were observed in mitochondrial respiration and cell size in abdominal and gluteal adipose tissue after HIT in either group of women. ,"['women with PCOS randomly allocated to either', 'Women With Polycystic Ovary Syndrome', 'women with PCOS', 'healthy women']","[' low- or high-volume HIT ( n = 41; low-volume HIT, 10 × 1 min work bouts at maximal, sustainable intensity and high-volume HIT, 4 × 4 min work bouts at 90-95% of maximal heart rate) or non-exercise control ( n = 23), and in women without PCOS (Non-PCOS) allocated to low- or high volume HIT', 'sub maximal exercise before and after 16 weeks of high-intensity interval training (HIT', 'Exercise training']","['Fat Oxidation', 'body fat oxidation and mitochondrial respiration rates', 'mitochondrial respiration and cell size in abdominal and gluteal adipose tissue', 'Peak oxygen uptake']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0162658', 'cui_str': 'Cell Size'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",,0.0234977,No changes were observed in mitochondrial respiration and cell size in abdominal and gluteal adipose tissue after HIT in either group of women. ,"[{'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Lionett', 'Affiliation': 'Department of Circulation and Medical Imaging, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Ida Almenning', 'Initials': 'IA', 'LastName': 'Kiel', 'Affiliation': 'Department of Circulation and Medical Imaging, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Ragnhild', 'Initials': 'R', 'LastName': 'Røsbjørgen', 'Affiliation': 'Department of Circulation and Medical Imaging, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Stian', 'Initials': 'S', 'LastName': 'Lydersen', 'Affiliation': 'Department of Mental Health, Regional Centre for Child and Youth Mental Health and Child Welfare, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Steen', 'Initials': 'S', 'LastName': 'Larsen', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Trine', 'Initials': 'T', 'LastName': 'Moholdt', 'Affiliation': 'Department of Circulation and Medical Imaging, Norwegian University of Science and Technology, Trondheim, Norway.'}]",Frontiers in physiology,['10.3389/fphys.2021.649794'] 3411,33840937,Randomized double-blind trial comparing effects of low-flow vs high-flow anesthesia on postoperative lung functions using respirometer.,"Background and Aims Modern anesthetic practice utilizes low-flow anesthesia with evolving evidence on its pulmonary effects. Studies comparing measurement of vital capacity and inspiratory reserve volume using respirometer in both low-flow and high-flow anesthesia are sparse. We evaluated the effects of low-flow and high-flow anesthesia on postoperative pulmonary functions using respirometer. Material and Methods This was a prospective randomized double blind study wherein One hundred and ten patients undergoing peripheral surgeries under general anesthesia were allocated into two groups Group I- Low-flow anesthesia with O2 + N2O + Sevoflurane (0.5L + 0.5L + 3.5%) and Group II- High-flow anesthesia with O2 + N2O + Sevoflurane (2L + 2L + 2%). The difference in vital capacity (VC), inspiratory reserve volume (IRV), and peak expiratory flow rates (PEFR) from the preoperative period were compared in both the groups postoperatively. Results The difference in VC, IRV, and PEFR measured in both the groups between the preoperative and postoperative period were found to be similar and statistically insignificant ( P - 0.173, 1.00 and 0.213 respectively). The difference in single breath count (SBC), breath holding time (BHT), and respiratory rates (RR) were also similar in both the groups ( P - 0.101, 0.698, and 0.467) respectively. Conclusions The pulmonary effects of low-flow anesthesia are comparable with the high-flow ones in patients undergoing elective surgeries under general anesthesia.",2020,"The difference in VC, IRV, and PEFR measured in both the groups between the preoperative and postoperative period were found to be similar and statistically insignificant ( P - 0.173, 1.00 and 0.213 respectively).","['patients undergoing elective surgeries under general anesthesia', 'One hundred and ten patients undergoing peripheral surgeries under general anesthesia']","['Low-flow anesthesia with O2 + N2O + Sevoflurane (0.5L + 0.5L + 3.5%) and Group II- High-flow anesthesia with O2 + N2O + Sevoflurane (2L + 2L + 2', 'low-flow anesthesia', 'low-flow and high-flow anesthesia', 'low-flow vs high-flow anesthesia']","['postoperative lung functions', 'VC, IRV, and PEFR', 'single breath count (SBC), breath holding time (BHT), and respiratory rates (RR', 'vital capacity (VC), inspiratory reserve volume (IRV), and peak expiratory flow rates (PEFR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0021613', 'cui_str': 'Inspiratory reserve volume'}, {'cui': 'C0030735', 'cui_str': 'Peak expiratory flow rate'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0235744', 'cui_str': 'Interrupted breathing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0042834', 'cui_str': 'Vital capacity'}]",110.0,0.0405361,"The difference in VC, IRV, and PEFR measured in both the groups between the preoperative and postoperative period were found to be similar and statistically insignificant ( P - 0.173, 1.00 and 0.213 respectively).","[{'ForeName': 'T Krishna', 'Initials': 'TK', 'LastName': 'Prasad', 'Affiliation': 'Department of Anesthesiology, Shri Sathya Sai Medical College and Research Institute, (Sri Balaji Vidyapeeth, Deemed to be University), Kancheepuram, Tamil Nadu, India.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Gnanasekar', 'Affiliation': 'Department of Anesthesiology, Shri Sathya Sai Medical College and Research Institute, (Sri Balaji Vidyapeeth, Deemed to be University), Kancheepuram, Tamil Nadu, India.'}, {'ForeName': 'K Soundarya', 'Initials': 'KS', 'LastName': 'Priyadharsini', 'Affiliation': 'Department of Pharmacology, Shri Sathya Sai Medical College and Research Institute, (Sri Balaji Vidyapeeth, Deemed to be University), Kancheepuram, Tamil Nadu, India.'}, {'ForeName': 'Robin Sajan', 'Initials': 'RS', 'LastName': 'Chacko', 'Affiliation': 'Department of Anesthesiology, Shri Sathya Sai Medical College and Research Institute, (Sri Balaji Vidyapeeth, Deemed to be University), Kancheepuram, Tamil Nadu, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_410_19'] 3412,33835842,Health-Related Quality of Life With Trastuzumab Monotherapy Versus Trastuzumab Plus Standard Chemotherapy as Adjuvant Therapy in Older Patients With HER2-Positive Breast Cancer.,"PURPOSE We report findings on quality of life (QoL) in the RESPECT trial, which compared adjuvant trastuzumab monotherapy with trastuzumab plus chemotherapy in older patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer (BC). PATIENTS AND METHODS Patients age 70-80 years with human epidermal growth factor receptor 2-positive surgically treated breast cancer were randomly assigned to receive trastuzumab (T) or trastuzumab plus chemotherapy (T + C). QoL was assessed using the Functional Assessment of Cancer Therapy-General (FACT-G), Philadelphia Geriatric Center Morale Scale, Hospital Anxiety and Depression Scale, Patient Neurotoxicity Questionnaire, and Tokyo Metropolitan Institute of Gerontology Index of Competence at baseline and after 2, 12, and 36 months. Comparisons were based on individual changes from baseline and were performed by Fisher's test or mixed-model repeated-measures. RESULTS Among 275 patients in the parent study, 231 (84%) (average age: 74 years) were included in the analysis. At 2, 12, and 36 months, 198, 177, and 178 patients completed surveys, and the mean FACT-G scores at each survey point were 78.9, 80.4, 82.7, and 79.1 in group T and 79.5, 74.5, 78.4, and 78.5 in group T + C. Compared with group T + C, the proportion of patients showing QoL deterioration (≥ 5 points decrease from baseline in FACT-G) was significantly lower at 2 months (31% v 48%; P = .016) and 12 months (19% v 38%; P = .009). In group T, the Hospital Anxiety and Depression Scale score ( P = .003) and the proportion of severe sensory peripheral neuropathy ( P = .001) were significantly lower at 2 months, and Philadelphia Geriatric Center Morale Scale and Tokyo Metropolitan Institute of Gerontology Index of Competence scores were significantly higher ( P = .024, .042) at 12 months. At 36 months, there were no significant differences in any QoL items. CONCLUSION Detrimental effects of adjuvant chemotherapy on global QoL, morale, and activity capacity lasted for at least 12 months but were not observed at 36 months.",2021,"In group T, the Hospital Anxiety and Depression Scale score ( P = .003) and the proportion of severe sensory peripheral neuropathy ( P = .001) were significantly lower at 2 months, and Philadelphia Geriatric Center Morale Scale and Tokyo Metropolitan Institute of Gerontology Index of Competence scores were significantly higher ( P = .024, .042) at 12 months.","['Patients age 70-80 years with human epidermal growth factor receptor 2-positive surgically treated breast cancer', 'older patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer (BC', 'Older Patients With HER2-Positive Breast Cancer', '275 patients in the parent study, 231 (84%) (average age: 74 years']","['adjuvant chemotherapy', 'Trastuzumab Monotherapy', 'trastuzumab (T) or trastuzumab plus chemotherapy (T + C', 'Trastuzumab Plus Standard Chemotherapy', 'trastuzumab plus chemotherapy']","['QoL items', 'QoL deterioration', 'Philadelphia Geriatric Center Morale Scale and Tokyo Metropolitan Institute of Gerontology Index of Competence scores', 'global QoL, morale, and activity capacity', 'Hospital Anxiety and Depression Scale score', 'mean FACT-G scores', 'quality of life (QoL', 'Functional Assessment of Cancer Therapy-General (FACT-G), Philadelphia Geriatric Center Morale Scale, Hospital Anxiety and Depression Scale, Patient Neurotoxicity Questionnaire, and Tokyo Metropolitan Institute of Gerontology Index of Competence', 'proportion of severe sensory peripheral neuropathy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451377', 'cui_str': 'Philadelphia geriatric center morale scale'}, {'cui': 'C0040371', 'cui_str': 'Tokyo'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0026530', 'cui_str': 'Morale'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxicity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy'}]",275.0,0.0980594,"In group T, the Hospital Anxiety and Depression Scale score ( P = .003) and the proportion of severe sensory peripheral neuropathy ( P = .001) were significantly lower at 2 months, and Philadelphia Geriatric Center Morale Scale and Tokyo Metropolitan Institute of Gerontology Index of Competence scores were significantly higher ( P = .024, .042) at 12 months.","[{'ForeName': 'Naruto', 'Initials': 'N', 'LastName': 'Taira', 'Affiliation': 'Department of Breast and Endocrine Surgery, Okayama University Hospital, Okayama, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Sawaki', 'Affiliation': 'Department of Breast Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Yukari', 'Initials': 'Y', 'LastName': 'Uemura', 'Affiliation': 'Biostatistics Section, Department of Data Science, Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Saito', 'Affiliation': 'Department of Surgery, Japanese Red Cross Saitama Hospital, Saitama, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Baba', 'Affiliation': 'Department of Surgery, Sagara Hospital, Kagoshima, Japan.'}, {'ForeName': 'Kokoro', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Medical Oncology, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Kawashima', 'Affiliation': 'Department of Surgery, Aomori City Hospital, Aomori, Japan.'}, {'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Tsuneizumi', 'Affiliation': 'Department of Breast Surgery, Shizuoka General Hospital, Shizuoka, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Sagawa', 'Affiliation': 'Department of Breast Surgery, Kameda Medical Center, Kamogawa, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Bando', 'Affiliation': 'Department of Breast and Endocrine Surgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Department of Breast Surgery, NHO Hokkaido Cancer Center, Sapporo, Japan.'}, {'ForeName': 'Miki', 'Initials': 'M', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Breast Surgery, JCHO Kurume General Hospital, Kurume, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takashima', 'Affiliation': 'Department of Breast and Endocrine Surgery, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Nakayama', 'Affiliation': 'Department of Breast and Endocrine Surgery, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Kashiwaba', 'Affiliation': 'Department of Breast Surgery, Adachi Breast Clinic, Kyoto, Japan.'}, {'ForeName': 'Toshiro', 'Initials': 'T', 'LastName': 'Mizuno', 'Affiliation': 'Department of Medical Oncology, Mie University Hospital, Tsu, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Breast and Endocrine Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Hiroji', 'Initials': 'H', 'LastName': 'Iwata', 'Affiliation': 'Department of Breast Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Ohashi', 'Affiliation': 'Department of Integrated Science and Engineering for Sustainable Society, Chuo University, Tokyo, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Mukai', 'Affiliation': 'Department of Breast and Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Kawahara', 'Affiliation': 'Biostatistics Division, Clinical Research Support Center, The University of Tokyo Hospital, Tokyo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.02751'] 3413,33835823,Radiofrequency vs. Cryoballoon Catheter Ablation for Paroxysmal Atrial Fibrillation: Durability of Pulmonary Vein Isolation and Effect on AF Burden: The RACE-AF Randomized Controlled Trial.,"Background - Recurrent paroxysmal atrial fibrillation (PAF) after catheter ablation is presumably caused by failure to achieve durable pulmonary vein isolation (PVI). The primary methods of PVI are radiofrequency (RF) and cryoballoon (CRYO) catheter ablation, but these methods have not been directly compared with respect to PVI durability and the effect thereof on AF burden (% of time in AF). Methods - Accordingly, we performed a randomized trial including 98 patients (68% male, 61 [55-67] years) with PAF assigned 1:1 to PVI by contact-force sensing, irrigated RF catheter or second-generation CRYO catheter. Implantable cardiac monitors were inserted ≥1 month before PVI for assessment of AF burden and recurrence, and all patients, irrespective of AF recurrence, underwent a second procedure 4-6 months after PVI to determine PVI durability. Results - In the second procedure, 152/199 (76%) pulmonary veins (PVs) were found durably isolated after RF and 161/200 (81%) after CRYO (NS), corresponding to durable isolation of all veins in 47% of patients in both groups (NS). Median AF burden before PVI was 5.4% (interquartile range: 0.5-13.0%) vs. 4.0% (0.6-18.1%), RF vs. CRYO, and reduced to 0.0% (0.0-0.1%) and 0.0% (0.0-0.5%), respectively - a reduction of 99.9% (92.9-100.0%) and 99.3% (85.9-100.0%) (all NS). AF burden after PVI significantly correlated to the number of durably isolated PVs (p < 0.01), but 9/45 (20%) patients with durable isolation of all veins had recurrence of AF within 4-6 months after PVI (excluding a 3-month blanking period). Conclusions - PVI by RF and CRYO catheter ablation produce similar moderate to high PVI durability. Both treatments lead to marked reductions in AF burden, which is related to the number of durably isolated PVs. However, for one fifth of PAF patients, complete and durable PVI was not sufficient to prevent even short-term AF recurrence.",2021,"AF burden after PVI significantly correlated to the number of durably isolated PVs (p < 0.01), but 9/45 (20%) patients with durable isolation of all veins had recurrence of AF within 4-6 months after PVI (excluding a 3-month blanking period). ","['98 patients (68% male, 61 [55-67] years) with PAF assigned 1:1 to', 'Paroxysmal Atrial Fibrillation']","['Radiofrequency vs. Cryoballoon Catheter Ablation', 'PVI are radiofrequency (RF) and cryoballoon (CRYO) catheter ablation', 'RF and CRYO catheter ablation', 'PVI by contact-force sensing, irrigated RF catheter or second-generation CRYO catheter']","['recurrence of AF', 'Median AF burden before PVI', 'complete and durable PVI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032172', 'cui_str': 'Platelet activating factor'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}]","[{'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",98.0,0.0536279,"AF burden after PVI significantly correlated to the number of durably isolated PVs (p < 0.01), but 9/45 (20%) patients with durable isolation of all veins had recurrence of AF within 4-6 months after PVI (excluding a 3-month blanking period). ","[{'ForeName': 'Samuel K', 'Initials': 'SK', 'LastName': 'Sørensen', 'Affiliation': 'Copenhagen University Hospital Gentofte, Gentofte Hospitalsvej 1, Hellerup, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Johannessen', 'Affiliation': 'Copenhagen University Hospital Gentofte, Gentofte Hospitalsvej 1, Hellerup, Denmark.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Worck', 'Affiliation': 'Copenhagen University Hospital Gentofte, Gentofte Hospitalsvej 1, Hellerup, Denmark.'}, {'ForeName': 'Morten L', 'Initials': 'ML', 'LastName': 'Hansen', 'Affiliation': 'Copenhagen University Hospital Gentofte, Gentofte Hospitalsvej 1, Hellerup, Denmark.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Hansen', 'Affiliation': 'Copenhagen University Hospital Gentofte, Gentofte Hospitalsvej 1, Hellerup, Denmark.'}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.120.009573'] 3414,33835315,Teaching Medical Students to Help Patients Manage Their Weight: Outcomes of an Eight-School Randomized Controlled Trial.,"BACKGROUND Given the rising rates of obesity there is a pressing need for medical schools to better prepare students for intervening with patients who have overweight or obesity and for prevention efforts. OBJECTIVE To assess the effect of a multi-modal weight management curriculum on counseling skills for health behavior change. DESIGN A pair-matched, group-randomized controlled trial (2015-2020) included students enrolled in eight U.S. medical schools randomized to receive either multi-modal weight management education (MME) or traditional weight management education (TE). SETTING/PARTICIPANTS Students from the class of 2020 (N=1305) were asked to participate in an objective structured clinical examination (OSCE) focused on weight management counseling and complete pre and post surveys. A total of 70.1% of eligible students (N=915) completed the OSCE and 69.3% (N=904) completed both surveys. INTERVENTIONS The MME implemented over three years included a web-based course, a role-play classroom exercise, a web-patient encounter with feedback, and an enhanced clerkship experience with preceptors trained in weight management counseling (WMC). Counseling focused on the 5As (Ask, Advise, Assess, Assist, Arrange) and patient-centeredness. MEASUREMENTS The outcome was student 5As WMC skills assessed using an objective measure, an OSCE, scored using a behavior checklist, and a subjective measure, student self-reported skills for performing the 5As. RESULTS Among MME students who completed two of three WMC components compared to those who completed none, exposure was significantly associated with higher OSCE scores and self-reported 5A skills. LIMITATIONS Variability in medical schools requiring participation in the WMC curriculum. CONCLUSIONS This trial revealed that medical students struggle with delivering weight management counseling to their patients who have overweight or obesity. Medical schools, though restrained in adding curricula, should incorporate should incorporate multiple WMC curricula components early in medical student education to provide knowledge and build confidence for supporting patients in developing individualized plans for weight management. NIH TRIAL REGISTRY NUMBER R01-194787.",2021,"Among MME students who completed two of three WMC components compared to those who completed none, exposure was significantly associated with higher OSCE scores and self-reported 5A skills. ","['medical schools to better prepare students for intervening with patients who have overweight or obesity and for prevention efforts', 'A pair-matched, group-randomized controlled trial (2015-2020) included students enrolled in eight U.S. medical schools', 'medical schools requiring participation in the WMC curriculum', 'Teaching Medical Students to Help Patients Manage Their Weight', 'medical students struggle with delivering weight management counseling to their patients who have overweight or obesity', 'A total of 70.1% of eligible students (N=915) completed the OSCE and 69.3% (N=904) completed both surveys', 'Students from the class of 2020']","['multi-modal weight management curriculum', 'preceptors trained in weight management counseling (WMC', 'multi-modal weight management education (MME) or traditional weight management education (TE']","['student 5As WMC skills assessed using an objective measure, an OSCE, scored using a behavior checklist, and a subjective measure, student self-reported skills for performing the 5As', 'OSCE scores and self-reported 5A skills']","[{'cui': 'C0036378', 'cui_str': 'Medical School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]",,0.0408425,"Among MME students who completed two of three WMC components compared to those who completed none, exposure was significantly associated with higher OSCE scores and self-reported 5A skills. ","[{'ForeName': 'Judith K', 'Initials': 'JK', 'LastName': 'Ockene', 'Affiliation': 'Department of Population and Quantitative Health Sciences, Division of Preventive and Behavioral Medicine, University of Massachusetts Medical School, 368 Plantation Street, Worcester, MA, 01605, USA. judith.ockene@umassmed.edu.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Pbert', 'Affiliation': 'Department of Population and Quantitative Health Sciences, Division of Preventive and Behavioral Medicine, University of Massachusetts Medical School, 368 Plantation Street, Worcester, MA, 01605, USA.'}, {'ForeName': 'Sybil', 'Initials': 'S', 'LastName': 'Crawford', 'Affiliation': 'Department of Population and Quantitative Health Sciences, Division of Preventive and Behavioral Medicine, University of Massachusetts Medical School, 368 Plantation Street, Worcester, MA, 01605, USA.'}, {'ForeName': 'Christine F', 'Initials': 'CF', 'LastName': 'Frisard', 'Affiliation': 'Department of Population and Quantitative Health Sciences, Division of Preventive and Behavioral Medicine, University of Massachusetts Medical School, 368 Plantation Street, Worcester, MA, 01605, USA.'}, {'ForeName': 'Jyothi A', 'Initials': 'JA', 'LastName': 'Pendharkar', 'Affiliation': 'Department of Population and Quantitative Health Sciences, Division of Preventive and Behavioral Medicine, University of Massachusetts Medical School, 368 Plantation Street, Worcester, MA, 01605, USA.'}, {'ForeName': 'Rajani S', 'Initials': 'RS', 'LastName': 'Sadasivam', 'Affiliation': 'Department of Population and Quantitative Health Sciences, Division of Preventive and Behavioral Medicine, University of Massachusetts Medical School, 368 Plantation Street, Worcester, MA, 01605, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Faro', 'Affiliation': 'Department of Population and Quantitative Health Sciences, Division of Preventive and Behavioral Medicine, University of Massachusetts Medical School, 368 Plantation Street, Worcester, MA, 01605, USA.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Okuliar', 'Affiliation': 'Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Cassie', 'Initials': 'C', 'LastName': 'Eno', 'Affiliation': 'Creighton University School of Medicine, Omaha, NE, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Margo', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Monica Ann', 'Initials': 'MA', 'LastName': 'Shaw', 'Affiliation': 'University of Louisville School of Medicine, Louisville, KY, USA.'}, {'ForeName': 'Taraneh', 'Initials': 'T', 'LastName': 'Soleymani', 'Affiliation': 'Previously at the University of Alabama, Birmingham, AL and now at Penn State Health, Middletown, PA, USA.'}, {'ForeName': 'Diane D', 'Initials': 'DD', 'LastName': 'Stadler', 'Affiliation': 'Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Sarita', 'Initials': 'S', 'LastName': 'Warrier', 'Affiliation': 'Brown University, Providence, RI, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'White', 'Affiliation': 'University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Alan C', 'Initials': 'AC', 'LastName': 'Geller', 'Affiliation': 'Department of Social and Behavioral Sciences, Harvard School of Public Health, Cambridge, MA, USA.'}]",Journal of general internal medicine,['10.1007/s11606-020-06571-x'] 3415,33834138,Comparison of antifungal efficacy of ethanolic extracts of Woodfordia fruticosa leaf and Punica granatum peel in uncontrolled diabetic patients wearing removable dentures: A randomized controlled clinical trial.,"Background and Purpose The search for the development of a suitable novel antimicrobial agent for fungal diseases continues to be a key problem in the current clinical field. The present investigation was aimed to determine the antifungal effect of the ethanolic crude extracts of Woodfordia fruticosa leaf (Wfl) and Punica granatum peel (Pgp) in uncontrolled diabetic patients wearing removable dentures. Materials and Methods The ethanolic extracts of both plants were prepared using the soxhlet extraction method, and the obtained metabolites were confirmed by thin- layer chromatography. After the preparation of the mouthwash, a total of 100 subjects were randomly divided into two groups. Each subject was given physiological saline at the baseline. Group I was provided with P. granatum mouthwash, while Group II was given W. fruticosa mouthwash. Following the administration of the mouthwash, the patients were requested to rinse the mouthwash using the oral rinse technique twice daily 5 ml/rinse for 30 sec. Subsequently, colony-forming units (CFU) were evaluated in the participants. Post-therapeutic samples were collected 1 h and 1 week after the mouthwash use. Results The mean reduction of CFU was calculated at the baseline, as well as 1 h and 1 week after using mouthwash. The results indicated a drastic reduction in CFU 1 h and 1 week after the application of Wfl mouthwash. Conclusion The obtained data revealed that Wfl had potential anticandidal activity against Candida yeast cells, probably owing to its bioactive compounds like glycosides. Therefore, this agent can be used effectively as a natural remedy for the treatment of oral candidiasis. However, the exact mechanism of action of this plant needs to be elucidated.",2020,"The results indicated a drastic reduction in CFU 1 h and 1 week after the application of Wfl mouthwash. ","['uncontrolled diabetic patients wearing removable dentures', '100 subjects']","['granatum peel', 'ethanolic extracts', 'ethanolic crude extracts of Woodfordia fruticosa leaf (Wfl) and Punica granatum peel (Pgp']",['mean reduction of CFU'],"[{'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011394', 'cui_str': 'Denture'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0237849', 'cui_str': 'Peeling of skin'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C1258023', 'cui_str': 'Extracts, Complex'}, {'cui': 'C1068386', 'cui_str': 'Woodfordia'}, {'cui': 'C0242724', 'cui_str': 'Leaves'}, {'cui': 'C1509685', 'cui_str': 'POMEGRANATE FRUIT EXTRACT'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit'}]",100.0,0.0313982,"The results indicated a drastic reduction in CFU 1 h and 1 week after the application of Wfl mouthwash. ","[{'ForeName': 'Bhavana', 'Initials': 'B', 'LastName': 'Sujanamulk', 'Affiliation': 'Department of Oral Medicine and Radiology, Drs Sudha and Nageswararao Siddhartha Institute of Dental Sciences, Gannavaram Mandal, Krishna District, Andhrapradesh, India.'}, {'ForeName': 'Salavadhi', 'Initials': 'S', 'LastName': 'Shyam Sunder', 'Affiliation': 'Department of Periodontics, Chhattisgarh Dental College and Research Institute, Rajnandgaon, Chhattisgarh, India.'}, {'ForeName': 'Babita', 'Initials': 'B', 'LastName': 'Ratnakar Pawar', 'Affiliation': 'Department of Periodontics, Chhattisgarh Dental College and Research Institute, Rajnandgaon, Chhattisgarh, India.'}, {'ForeName': 'Chintamaneni', 'Initials': 'C', 'LastName': 'Rajalakshmi', 'Affiliation': 'Department of Oral Medicine and Radiology, Drs Sudha and Nageswararao Siddhartha Institute of Dental Sciences, Gannavaram Mandal, Krishna District, Andhrapradesh, India.'}, {'ForeName': 'Kotya', 'Initials': 'K', 'LastName': 'Naik Maloth', 'Affiliation': 'Department of Oral Medicine and Radiology, Mamata Dental College, Khammam, Telangana, India.'}]",Current medical mycology,['10.18502/cmm.6.3.3983'] 3416,33834054,Effect of fexofenadine hydrochloride on allergic rhinitis aggravated by air pollutants.,"In recent decades, seasonal allergic rhinitis (SAR) prevalence has increased and recent studies have shown that air pollutants, such as diesel exhaust particles (DEP), can increase inflammatory and allergic biomarkers. The aim of this study was to investigate the effects of DEP on SAR symptoms induced by ragweed and to evaluate the efficacy and safety of fexofenadine HCl 180 mg versus placebo. This phase 3, single-centre, sequential, parallel-group, double-blind, randomised study (NCT03664882) was conducted in an environmental exposure unit (EEU) during sequential exposures: Period 1 (ragweed pollen alone), Period 2 (ragweed pollen+DEP), and Period 3 (ragweed pollen+DEP+single-dose fexofenadine HCl 180 mg or placebo). Efficacy and safety were evaluated in Period 3. Primary endpoints were the area under the curve (AUC) of total nasal symptom score (TNSS) from baseline to hour 12 (AUC 0-12 ) during Period 1 and Period 2; and the AUC of the TNSS from hour 2 to 12 (AUC 2-12 ) during Period 3. 251 out of 257 evaluable subjects were included in the modified intent-to-treat population. Least squares mean difference (95% CI) for TNSS Log AUC 0-12 in Period 2 versus Period 1 was 0.13 (0.081-0.182; p<0.0001). Least squares mean difference in TNSS Log AUC 2-12 for fexofenadine HCl versus placebo during Period 3 was -0.24 (-0.425--0.047; p=0.0148). One fexofenadine HCl-related adverse event was observed. SAR symptoms evoked by ragweed were aggravated by DEP. Fexofenadine HCl 180 mg was effective in relieving pollen-induced, air pollution-aggravated allergic rhinitis symptoms.",2021,"Fexofenadine HCl 180 mg was effective in relieving pollen-induced, air pollution-aggravated allergic rhinitis symptoms.","['allergic rhinitis aggravated by air pollutants', '251 out of 257 evaluable subjects were included in the modified intent-to-treat population']","['environmental exposure unit (EEU) during sequential exposures: Period 1 (ragweed pollen alone), Period 2 (ragweed pollen+DEP), and Period 3 (ragweed pollen+DEP+single-dose fexofenadine HCl 180\u2005mg or placebo', 'Fexofenadine HCl', 'DEP', 'fexofenadine HCl 180\u2005mg versus placebo', 'fexofenadine hydrochloride', 'fexofenadine HCl', 'fexofenadine HCl versus placebo']","['efficacy and safety', 'area under the curve (AUC) of total nasal symptom score (TNSS', 'SAR symptoms', 'relieving pollen-induced, air pollution-aggravated allergic rhinitis symptoms', 'SAR symptoms evoked', 'Efficacy and safety']","[{'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0436331', 'cui_str': 'Symptom aggravating factors'}, {'cui': 'C0001869', 'cui_str': 'Air Pollutants'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0014412', 'cui_str': 'Environmental exposure'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0440357', 'cui_str': 'Ragweed pollen'}, {'cui': 'C0331432', 'cui_str': 'Ambrosia'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0771752', 'cui_str': 'Fexofenadine hydrochloride'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012151', 'cui_str': 'Diesel Exhaust'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018621', 'cui_str': 'Seasonal allergic rhinitis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0032385', 'cui_str': 'Pollen'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}, {'cui': 'C0436331', 'cui_str': 'Symptom aggravating factors'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}]",257.0,0.0816353,"Fexofenadine HCl 180 mg was effective in relieving pollen-induced, air pollution-aggravated allergic rhinitis symptoms.","[{'ForeName': 'Anne K', 'Initials': 'AK', 'LastName': 'Ellis', 'Affiliation': ""Division of Allergy and Immunology, Dept of Medicine, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Murrieta-Aguttes', 'Affiliation': 'Sanofi Consumer Health Care, Gentilly, France.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Furey', 'Affiliation': 'Sanofi Consumer Health Care, Bridgewater, MA, USA.'}, {'ForeName': 'Pascaline', 'Initials': 'P', 'LastName': 'Picard', 'Affiliation': 'Ividata, Levallois Perret, France.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Carlsten', 'Affiliation': 'Air Pollution Exposure Laboratory, University of British Columbia, Vancouver, BC, Canada.'}]",ERJ open research,['10.1183/23120541.00806-2020'] 3417,33833974,Vitamin D Effect on Ultrasonography and Laboratory Indices and Biochemical Indicators in the Blood: an Interventional Study on 12 to 18-Year-Old Children with Fatty Liver.,"Purpose The rising prevalence of childhood obesity in the past decades has caused non-alcoholic fatty liver disease (NAFLD) to become the most common cause of pediatric chronic liver disease worldwide. This study was aimed at determining the effect of vitamin D (Vit D) on ultrasonography and laboratory indices of NAFLD and some blood biochemical indicators in children. Methods In this interventional study liver ultrasonography was performed in 200 children with overweight and obesity. A 108 had fatty liver among which 101 were randomly divided into two groups of study (n=51) and control (n=50). The study group was treated with Vit D, 50000 U once a week whereas the control group received placebo with the same dose and package, both for 12 weeks. At the end of the intervention lab tests and ultrasound study was performed once again to evaluate the response to treatment. Results It was found out that Vit D supplementation improved the fatty liver grade in the study group. The mean changes in hemoglobin (Hb), uric acid, highdensity lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), insulin, albumin and alanine aminotransferase (ALT) was significantly higher in the study group compared to controls ( p <0.05). After the intervention and means adjustment, a significant difference was obtained in HDL-C, insulin, LDL-C and homeostasis model assessment of insulin resistance (HOMA-IR) between the two groups. Conclusion Vit D supplementation in addition to improving the fatty liver grade in ultrasonography and increasing the blood Vit D level, increases the HDL and Hb level besides decreasing uric acid, LDL, HOMA-IR, insulin and ALT levels.",2021,"After the intervention and means adjustment, a significant difference was obtained in HDL-C, insulin, LDL-C and homeostasis model assessment of insulin resistance (HOMA-IR) between the two groups. ","['children', '12 to 18-Year-Old Children with Fatty Liver', 'A 108 had fatty liver among which 101 were randomly divided into two groups of study (n=51) and control (n=50', '200 children with overweight and obesity']","['Vitamin D', 'vitamin D (Vit D', 'placebo', 'Vit D', 'Vit D supplementation']","['uric acid, LDL, HOMA-IR, insulin and ALT levels', 'mean changes in hemoglobin (Hb), uric acid, highdensity lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), insulin, albumin and alanine aminotransferase (ALT', 'HDL-C, insulin, LDL-C and homeostasis model assessment of insulin resistance (HOMA-IR', 'fatty liver grade in ultrasonography and increasing the blood Vit D level', 'Ultrasonography and Laboratory Indices and Biochemical Indicators', 'fatty liver grade']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0065055', 'cui_str': 'lipoprotein cholesterol'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",200.0,0.056793,"After the intervention and means adjustment, a significant difference was obtained in HDL-C, insulin, LDL-C and homeostasis model assessment of insulin resistance (HOMA-IR) between the two groups. ","[{'ForeName': 'Kokab', 'Initials': 'K', 'LastName': 'Namakin', 'Affiliation': 'Birjand Atherosclerosis and Coronary Artery Research Center, Birjand University of Medical Sciences (BUMS), Birjand, Iran.'}, {'ForeName': 'Mahya', 'Initials': 'M', 'LastName': 'Hosseini', 'Affiliation': 'Department of Pediatric, Student Research Center Birjand University of Medical Sciences, Birjand, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Zardast', 'Affiliation': 'Birjand Atherosclerosis and Coronary Artery Research Center, Birjand University of Medical Sciences (BUMS), Birjand, Iran.'}, {'ForeName': 'Mahyar', 'Initials': 'M', 'LastName': 'Mohammadifard', 'Affiliation': 'Fellowship of Interventional Radiology, Birjand University of Medical Sciences, Birjand, Iran.'}]","Pediatric gastroenterology, hepatology & nutrition",['10.5223/pghn.2021.24.2.187'] 3418,33833817,Clinical and Antimicrobial Evaluation of Copaifera langsdorffii Desf. Dental Varnish in Children: A Clinical Study.,"Background The objective of this study was to evaluate the clinical and microbiological efficacies of ( C. langsdorffii ) dental varnish in children at high risk of dental caries.. Methods This is a longitudinal, randomized, controlled clinical trial. Ninety high-risk caries-free children (ICDAS II = 0) were recruited and randomly divided into three groups: C. langsdorffii , chlorhexidine, or fluoride. The varnishes were applied on the second deciduous molars for three times: baseline (D0), after 90 days (D90), and after 180 days (D180). Saliva was collected on D0, D90, D180, and D360 to evaluate S. mutans reduction. Statistics were carried out by ANOVA, Tukey's test, and the paired t -test. Results Copaiba varnish demonstrated significant S. mutans reduction: D360 versus D0 ( p < 0.0001), D180 versus D0 ( p < 0.001), D360 versus D90 ( p < 0.001), D180 versus D90 ( p < 0.001), and D360 versus D180 ( p < 0.05). Chlorhexidine varnish significantly reduced S. mutans at D180 versus D0 ( p < 0.05). Fluoride reduced at D180 versus D0 ( p < 0.001). Conclusions Three annual applications of this varnish showed substantial antimicrobial activity against S. mutans and caries prevention for up to 12 months.",2021,Chlorhexidine varnish significantly reduced S. mutans at D180 versus D0 ( p < 0.05).,"['Children', 'Ninety high-risk caries-free children (ICDAS II\u2009=\u20090', 'children at high risk of dental caries']","[' C. langsdorffii ) dental varnish', 'langsdorffii , chlorhexidine, or fluoride', 'Dental Varnish', 'Fluoride', 'Chlorhexidine varnish']","['substantial antimicrobial activity against S. mutans and caries prevention', 'reduced S. mutans']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]","[{'cui': 'C0440150', 'cui_str': 'Dental varnish'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0042359', 'cui_str': 'Varnish'}]","[{'cui': 'C1271650', 'cui_str': 'Antimicrobial activity'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",90.0,0.160234,Chlorhexidine varnish significantly reduced S. mutans at D180 versus D0 ( p < 0.05).,"[{'ForeName': 'Lídia Audrey Rocha', 'Initials': 'LAR', 'LastName': 'Valadas', 'Affiliation': 'Federal University of Ceara, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Patrícia Leal Dantas', 'Initials': 'PLD', 'LastName': 'Lobo', 'Affiliation': 'Federal University of Ceara, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Said Gonçalves da Cruz', 'Initials': 'SGDC', 'LastName': 'Fonseca', 'Affiliation': 'Federal University of Ceara, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Francisco Vagnaldo', 'Initials': 'FV', 'LastName': 'Fechine', 'Affiliation': 'Federal University of Ceara, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Edilson Martins', 'Initials': 'EM', 'LastName': 'Rodrigues Neto', 'Affiliation': 'Federal University of Ceara, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Marta Maria de França', 'Initials': 'MMF', 'LastName': 'Fonteles', 'Affiliation': 'Federal University of Ceara, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Lorena Ribeiro', 'Initials': 'LR', 'LastName': 'de Aguiar Trévia', 'Affiliation': 'Federal University of Ceara, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Hilda Lara Prado', 'Initials': 'HLP', 'LastName': 'Vasconcelos', 'Affiliation': 'Federal University of Ceara, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Sandra Mara da Silva', 'Initials': 'SMDS', 'LastName': 'Lima', 'Affiliation': 'Federal University of Ceara, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Mara Assef Leitao', 'Initials': 'MAL', 'LastName': 'Lotif', 'Affiliation': 'Federal University of Ceara, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Analice Mendes Barreto', 'Initials': 'AMB', 'LastName': 'Fernandes', 'Affiliation': 'Federal University of Ceara, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Mary Anne Medeiros', 'Initials': 'MAM', 'LastName': 'Bandeira', 'Affiliation': 'Federal University of Ceara, Fortaleza, Ceará, Brazil.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2021/6647849'] 3419,33833793,1927 nm Thulium Laser Successfully Treats PostInflammatory Hyperpigmentation in Skin of Color.,"Background Treatment of postinflammatory hyperpigmentation (PIH) in patients with dark skin is challenging as the treatment itself might provoke paradoxical PIH. Only few studies examined the safety and efficacy of nonablative laser treatment in these patients. The objective was to examine efficacy and safety of nonablative 1927 nm wavelength laser followed by bleaching creams in the treatment of PIH. Methods It was a prospective interventional pilot study that was conducted during 2019. All patients were of Fitzpatrick skin type IV who had unsatisfactory response to topical bleaching creams used for at least three months. Patients received one to four sessions of laser treatment (6 weeks apart) followed by topical hydroquinone 4% cream twice daily for 6 weeks. Improvement was assessed by two blinded independent dermatologist evaluators. Results A total of nine patients were enrolled and the outcome could not be assessed in one patient who was lost for follow-up. The affected sites were the abdomen, face, and other body parts. Three of the eight evaluated patients had excellent response (37.5%), four had satisfactory response (50.0%), and one had nonsatisfactory response (12.5%). The downtime was manifested as edema and erythema that disappeared after 5 to 7 days. Improvement was more evident in first session and it declined in subsequent sessions. None of the patients had paradoxical pigmentation after treatment. Conclusions Low energy low density nonablative fractional 1927 nm wavelength laser treatment followed by topical hydroquinone 4% cream for 6 weeks is a safe and effective modality for improving PIH in patients with darker skin types.",2021,"None of the patients had paradoxical pigmentation after treatment. ","['patients with dark skin', 'patients with darker skin types', '1927\u2009nm Thulium Laser Successfully Treats PostInflammatory Hyperpigmentation in Skin of Color', 'All patients were of Fitzpatrick skin type IV who had unsatisfactory response to topical bleaching creams used for at least three months']","['nonablative 1927\u2009nm wavelength laser followed by bleaching creams', 'nonablative laser treatment', 'topical hydroquinone 4% cream', '\n\n\nTreatment of postinflammatory hyperpigmentation (PIH']","['edema and erythema', 'nonsatisfactory response', 'safety and efficacy', 'excellent response', 'paradoxical pigmentation', 'PIH', 'satisfactory response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332582', 'cui_str': 'Dark color'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0040066', 'cui_str': 'Thulium'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0333616', 'cui_str': 'Postinflammatory hyperpigmentation'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0441732', 'cui_str': 'Type 4'}, {'cui': 'C0439856', 'cui_str': 'Unsatisfactory'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C4082119', 'cui_str': 'Three months'}]","[{'cui': 'C0449819', 'cui_str': 'Wavelength'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C1955836', 'cui_str': 'Nonablative Laser Treatment'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0689149', 'cui_str': 'Hydroquinone 40 mg/g cutaneous cream'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0333616', 'cui_str': 'Postinflammatory hyperpigmentation'}]","[{'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0205310', 'cui_str': 'Paradoxical'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0333616', 'cui_str': 'Postinflammatory hyperpigmentation'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}]",9.0,0.0145923,"None of the patients had paradoxical pigmentation after treatment. ","[{'ForeName': 'Mana Abdullah', 'Initials': 'MA', 'LastName': 'Alharbi', 'Affiliation': 'Department of Dermatology, Imam Mohammad Ibn Saud Islamic University, Riyadh, Saudi Arabia.'}]",Dermatology research and practice,['10.1155/2021/5560386'] 3420,33833692,Doppler Flow Response Following Running Exercise Differs Between Healthy and Tendinopathic Achilles Tendons.,"Background The relationship between exercise-induced intratendinous blood flow (IBF) and tendon pathology or training exposure is unclear. Objective This study investigates the acute effect of running exercise on sonographic detectable IBF in healthy and tendinopathic Achilles tendons (ATs) of runners and recreational participants. Methods 48 participants (43 ± 13 years, 176 ± 9 cm, 75 ± 11 kg) performed a standardized submaximal 30-min constant load treadmill run with Doppler ultrasound ""Advanced dynamic flow"" examinations before (U pre ) and 5, 30, 60, and 120 min (U 5 -U 120 ) afterward. Included were runners (>30 km/week) and recreational participants (<10 km/week) with healthy (H run , n = 10; H rec , n = 15) or tendinopathic (T run , n = 13; T rec , n = 10) ATs. IBF was assessed by counting number [n] of intratendinous vessels. IBF data are presented descriptively (%, median [minimum to maximum range] for baseline-IBF and IBF-difference post-exercise). Statistical differences for group and time point IBF and IBF changes were analyzed with Friedman and Kruskal-Wallis ANOVA (α = 0.05). Results At baseline, IBF was detected in 40% (3 [1-6]) of H run , in 53% (4 [1-5]) of H rec , in 85% (3 [1-25]) of T run , and 70% (10 [2-30]) of T rec . At U 5 IBF responded to exercise in 30% (3 [-1-9]) of H run , in 53% (4 [-2-6]) of H rec , in 70% (4 [-10-10]) of T run , and in 80% (5 [1-10]) of T rec . While IBF in 80% of healthy responding ATs returned to baseline at U 30 , IBF remained elevated until U 120 in 60% of tendinopathic ATs. Within groups, IBF changes from U pre -U 120 were significant for H rec ( p < 0.01), T run ( p = 0.05), and T rec ( p < 0.01). Between groups, IBF changes in consecutive examinations were not significantly different ( p > 0.05) but IBF-level was significantly higher at all measurement time points in tendinopathic versus healthy ATs ( p < 0.05). Conclusion Irrespective of training status and tendon pathology, running leads to an immediate increase of IBF in responding tendons. This increase occurs shortly in healthy and prolonged in tendinopathic ATs. Training exposure does not alter IBF occurrence, but IBF level is elevated in tendon pathology. While an immediate exercise-induced IBF increase is a physiological response, prolonged IBF is considered a pathological finding associated with Achilles tendinopathy.",2021,"Within groups, IBF changes from U pre -U 120 were significant for H rec ( p < 0.01), T run ( p = 0.05), and T rec ( p < 0.01).","['healthy and tendinopathic Achilles tendons (ATs) of runners and recreational participants', 'Healthy and Tendinopathic Achilles Tendons', 'Included were runners (>30 km/week) and recreational participants (<10 km/week) with healthy (H run , n = 10; H rec , n = 15) or tendinopathic (T run , n = 13; T rec , n = 10) ATs', '48 participants (43 ± 13 years, 176 ± 9 cm, 75 ± 11 kg) performed a']","['standardized submaximal 30-min constant load treadmill run with Doppler ultrasound ""Advanced dynamic flow"" examinations', 'running exercise']","['IBF changes in consecutive examinations', 'IBF', 'Doppler Flow Response', 'IBF occurrence', 'time point IBF and IBF changes', 'IBF-level', 'IBF changes', 'IBF level', 'IBF data']","[{'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C2606415', 'cui_str': 'ZDHHC2 protein, human'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0162481', 'cui_str': 'Doppler ultrasound'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0595620', 'cui_str': 'Intratendinous route'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",48.0,0.0411735,"Within groups, IBF changes from U pre -U 120 were significant for H rec ( p < 0.01), T run ( p = 0.05), and T rec ( p < 0.01).","[{'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Risch', 'Affiliation': 'University Outpatient Clinic, Sports Medicine and Orthopedics, University of Potsdam, Potsdam, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Mayer', 'Affiliation': 'University Outpatient Clinic, Sports Medicine and Orthopedics, University of Potsdam, Potsdam, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cassel', 'Affiliation': 'University Outpatient Clinic, Sports Medicine and Orthopedics, University of Potsdam, Potsdam, Germany.'}]",Frontiers in physiology,['10.3389/fphys.2021.650507'] 3421,33833507,Improvement in Lung Function and Patient-Reported Outcomes in Patients with COPD with Comorbid Anxiety and Depression Receiving Nebulized Glycopyrrolate in the GOLDEN 3 and 4 Studies.,"Background Anxiety and depression (A/D) are common in patients with chronic obstructive pulmonary disease (COPD) and are often associated with lower adherence to treatment and worse patient-related outcomes. However, studies on the impact of comorbid A/D on responses to bronchodilators are limited. Methods This post hoc analysis of pooled data (N=861) from the GOLDEN 3 and 4 studies compared the efficacy and safety of nebulized glycopyrrolate (GLY) 25 µg in patients with moderate-to-very-severe COPD, grouped by self-reported A/D. Changes in forced expiratory volume in 1 second (FEV 1 ) and health-related quality of life determined by St George's Respiratory Questionnaire (SGRQ) scores in patients with or without comorbid A/D (A/D [+] or A/D [-]) were examined following 12 weeks of GLY 25 µg twice-daily (BID) or placebo treatment. Results A/D (+) patients were predominantly female, younger, included a higher proportion of current smokers, and had higher baseline SGRQ scores compared with the A/D (-) group. At 12 weeks, GLY resulted in placebo-adjusted improvements from baseline in FEV 1 of 46.9 mL (p=0.19; not significant) and 106.7 mL (p<0.0001), in the A/D (+) and A/D (-) groups, respectively. Improvements were observed with GLY compared to placebo in SGRQ scores, regardless of baseline A/D status; the placebo-adjusted least squares mean change from baseline in SGRQ total scores was -3.16 (p>0.05) and -3.34 (p<0.001), for the A/D (+) and A/D (-) groups, respectively. Despite numerical improvements in SGRQ scores with GLY in the A/D (+) group, a higher response to placebo was observed. GLY was generally well tolerated throughout 12 weeks of treatment; incidence of adverse events was higher in the A/D (+) group compared with the A/D (-) group in both treatment arms. Conclusion GLY 25 µg BID resulted in numerical improvements in FEV 1 , SGRQ total scores and SGRQ responder rates in patients with moderate-to-very-severe COPD, regardless of A/D status at baseline; significant improvements were noted only in the A/D (+) group. The results emphasize the importance of considering underlying comorbidities including A/D when evaluating the efficacy of COPD treatments.",2021,"Conclusion GLY 25 µg BID resulted in numerical improvements in FEV 1 , SGRQ total scores and SGRQ responder rates in patients with moderate-to-very-severe COPD, regardless of A/D status at baseline; significant improvements were noted only in the A/D (+) group.","['Patients with COPD with Comorbid Anxiety and Depression Receiving', 'patients with moderate-to-very-severe COPD', 'patients with chronic obstructive pulmonary disease (COPD']","['D ', 'nebulized glycopyrrolate (GLY', 'placebo', 'Nebulized Glycopyrrolate', 'placebo treatment']","['SGRQ scores', ""forced expiratory volume in 1 second (FEV 1 ) and health-related quality of life determined by St George's Respiratory Questionnaire (SGRQ) scores"", 'efficacy and safety', 'adverse events', 'baseline SGRQ scores', 'FEV 1 , SGRQ total scores and SGRQ responder rates', 'SGRQ total scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}]","[{'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.528735,"Conclusion GLY 25 µg BID resulted in numerical improvements in FEV 1 , SGRQ total scores and SGRQ responder rates in patients with moderate-to-very-severe COPD, regardless of A/D status at baseline; significant improvements were noted only in the A/D (+) group.","[{'ForeName': 'Nicola A', 'Initials': 'NA', 'LastName': 'Hanania', 'Affiliation': 'Section of Pulmonary, Critical Care and Sleep Medicine, Baylor College of Medicine, Houston, TX, 77030, USA.'}, {'ForeName': 'Abebaw M', 'Initials': 'AM', 'LastName': 'Yohannes', 'Affiliation': 'Department of Physical Therapy, Azusa Pacific University, Azusa, CA, USA.'}, {'ForeName': 'Ayca', 'Initials': 'A', 'LastName': 'Ozol-Godfrey', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tocco', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Goodin', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Sanjar', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S294053'] 3422,33838518,"The role of depression in the prediction of a ""late"" remission in first-episode psychosis: An analysis of the OPTiMiSE study.","OBJECTIVE The identification of predictors of psychosis remission could guide early clinical decision-making for treatment of first-episode schizophrenia (FES). METHODS We analyzed two non-independent subsamples of patients with FES ages 18-40 years from the OPTiMiSE study dataset to investigate the demographic and clinical factors that might help to differentiate ""late"" remitters (i.e., not in remission at week 2 or 4, but achieving remission within a 10-week follow-up period) from non-remitters within the same period. RESULTS Subsample 1 included 216 individuals (55 females, mean age 25.9 years) treated with amisulpride in an open-label design who were not in remission at week 2. Early symptomatic response between baseline and week 2 (odds ratio (OR) = 4.186, 95% confidence interval (CI) = 2.082-8.416, p < 0.001) and older age (OR = 1.081, 95% CI = 1.026-1.138, p = 0.003) were the only variables significantly associated with a higher probability of psychosis remission at week 4. Subsample 2 was composed of the 72 participants (19 females, mean age 25.1 years) who were not in remission at week 4 and completed a 6-week double-blind randomized trial comparing continuation of amisulpride with switch to olanzapine. Depression at baseline (as measured with the Calgary Depression Scale for Schizophrenia) was significantly associated with a nearly 3-fold lower likelihood of psychosis remission during the 10-week follow-up (hazard ratio = 2.865, 95% CI = 1.187-6.916, p = 0.019). CONCLUSION Our results reinforce the importance of assessing depressive symptoms in people with FES and support the relevance of an early response (as early as 2 weeks) as a predictor of clinical outcome in this population. CLINICAL TRIALS REGISTRATION ClinicalTrials.gov identifier: NCT01248195, https://clinicaltrials.gov/ct2/show/NCT01248195.",2021,"Depression at baseline (as measured with the Calgary Depression Scale for Schizophrenia) was significantly associated with a nearly 3-fold lower likelihood of psychosis remission during the 10-week follow-up (hazard ratio = 2.865, 95% CI = 1.187-6.916, p = 0.019). ","['Subsample 2 was composed of the 72 participants (19 females, mean age 25.1 years) who were not in remission at week 4', 'Subsample 1 included 216 individuals (55 females, mean age 25.9 years) treated with amisulpride in an open-label design who were not in remission at week 2', 'first-episode psychosis', 'patients with FES ages 18-40 years from the OPTiMiSE study dataset to investigate the demographic and clinical factors that might help to differentiate ""late"" remitters (i.e., not in remission at week 2 or 4, but achieving remission within a 10-week follow-up period) from non-remitters within the same period', 'people with FES']",['amisulpride with switch to olanzapine'],"['probability of psychosis remission', 'Depression', 'psychosis remission', 'Calgary Depression Scale for Schizophrenia', 'Early symptomatic response']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0103045', 'cui_str': 'Amisulpride'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0103045', 'cui_str': 'Amisulpride'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]",,0.45185,"Depression at baseline (as measured with the Calgary Depression Scale for Schizophrenia) was significantly associated with a nearly 3-fold lower likelihood of psychosis remission during the 10-week follow-up (hazard ratio = 2.865, 95% CI = 1.187-6.916, p = 0.019). ","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fraguas', 'Affiliation': '""Centro"" Mental Health Center, Institute of Psychiatry and Mental Health, IdISSC, Hospital Clínico San Carlos, Madrid, Spain; Department of Child and Adolescent Psychiatry, Institute of Psychiatry and Mental Health, Hospital General Universitario Gregorio Marañón, IiSGM, CIBERSAM, School of Medicine, Universidad Complutense, Madrid, Spain. Electronic address: david.fraguas@salud.madrid.org.'}, {'ForeName': 'Covadonga M', 'Initials': 'CM', 'LastName': 'Díaz-Caneja', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Institute of Psychiatry and Mental Health, Hospital General Universitario Gregorio Marañón, IiSGM, CIBERSAM, School of Medicine, Universidad Complutense, Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pina-Camacho', 'Affiliation': ""Department of Child and Adolescent Psychiatry, Institute of Psychiatry and Mental Health, Hospital General Universitario Gregorio Marañón, IiSGM, CIBERSAM, School of Medicine, Universidad Complutense, Madrid, Spain; Department of Child and Adolescent Psychiatry, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Winter van Rossum', 'Affiliation': 'Department of Psychiatry, University Medical Center Utrecht Brain Center, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Baandrup', 'Affiliation': 'Center for Neuropsychiatric Schizophrenia Research & Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research, Mental Health Center Glostrup, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Iris E', 'Initials': 'IE', 'LastName': 'Sommer', 'Affiliation': 'Department of Neuroscience, University Medical Center, Groningen, the Netherlands.'}, {'ForeName': 'Birte', 'Initials': 'B', 'LastName': 'Glenthøj', 'Affiliation': 'Center for Neuropsychiatric Schizophrenia Research & Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research, Mental Health Center Glostrup, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'René S', 'Initials': 'RS', 'LastName': 'Kahn', 'Affiliation': ""Department of Child and Adolescent Psychiatry, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK; Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.""}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Leucht', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Technical University of Munich, School of Medicine, Munich, Germany.'}, {'ForeName': 'Celso', 'Initials': 'C', 'LastName': 'Arango', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Institute of Psychiatry and Mental Health, Hospital General Universitario Gregorio Marañón, IiSGM, CIBERSAM, School of Medicine, Universidad Complutense, Madrid, Spain.'}]",Schizophrenia research,['10.1016/j.schres.2021.03.010'] 3423,33838357,Desmopressin effects on bleeding during functional endoscopic sinus surgery on patients with chronic rhinosinusitis.,"OBJECTIVE In this study we aimed to determine whether Desmopressin (DDAVP) can alter bleeding and improves surgeon visual field and decrease operation time or lessen use of anesthesiology medication in a clinical trial study. METHOD This study is a randomized clinical trial using the permuted block randomization method. 44 patients were enrolled in study and divided into two equal intervention-control groups. The intervention group received maximum dose of 0/2 micrograms per kg of DDAVP. In the control group, 30 min before the surgery, 100 ml of normal saline will be injected. RESULTS The amount of bleeding was 517/17 cc in control group during surgery while it was 387/72 cc in group receiving DDAVP which is significantly lower. The satisfaction of surgeon regarding suitable visual field was 6/45 in control group while it was 3/77 in DDAVP receivers which is lower. CONCLUSION It seems that intravenous DDAVP can reduce bleeding during surgery and offer an enhanced vision for surgeon during surgery but it has no potential efficacy on reduction of period of surgery and need for anesthesiology medication like remifentanil and isoflurane.",2021,"The satisfaction of surgeon regarding suitable visual field was 6/45 in control group while it was 3/77 in DDAVP receivers which is lower. ","['patients with chronic rhinosinusitis', '44 patients']","['maximum dose of 0/2 micrograms per kg of DDAVP', 'DDAVP', 'Desmopressin', 'Desmopressin (DDAVP']","['satisfaction of surgeon regarding suitable visual field', 'bleeding', 'amount of bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0701195', 'cui_str': 'Desmospray'}, {'cui': 'C0011701', 'cui_str': 'desmopressin'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",44.0,0.029551,"The satisfaction of surgeon regarding suitable visual field was 6/45 in control group while it was 3/77 in DDAVP receivers which is lower. ","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Hajimohamadi', 'Affiliation': 'Anesthesiology Research Center, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: hajimoha@sina.tums.ac.ir.'}, {'ForeName': 'Jawad', 'Initials': 'J', 'LastName': 'Hosseini', 'Affiliation': 'Otorhinolaryngology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farrokh', 'Initials': 'F', 'LastName': 'Heidari', 'Affiliation': 'Otorhinolaryngology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Alvandi', 'Affiliation': 'Otorhinolaryngology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Bastaninezhad', 'Affiliation': 'Otorhinolaryngology Research Center, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: shahinbastani@razi.tums.ac.ir.'}, {'ForeName': 'AmirHossein', 'Initials': 'A', 'LastName': 'Ghabasiah', 'Affiliation': 'Otorhinolaryngology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ardavan', 'Initials': 'A', 'LastName': 'Tajdini', 'Affiliation': 'Otorhinolaryngology Research Center, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: a-tajdini@sina.tums.ac.ir.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2021.103024'] 3424,33838349,"Lubiprostone for Pediatric Functional Constipation: Randomized, Controlled, Double-blind Study With Long-term Extension.","BACKGROUND & AIMS Pediatric functional constipation (PFC) is a common problem in children that causes distress and presents treatment challenges to healthcare professionals. We conducted a randomized, placebo-controlled trial (Study 1) in patients with PFC (aged 6-17 years) to evaluate the efficacy and safety of lubiprostone, followed by an open-label extension for those who completed the placebo-controlled phase (Study 2). METHODS Study 1 (NCT02042183) was a phase 3, multicenter, randomized, double-blind, placebo-controlled, 12-week study evaluating the efficacy and safety of lubiprostone 12 mcg twice-daily (BID) and 24 mcg BID. Study 2 (NCT02138136) was a phase 3, long-term, open-label extension of Study 1. In both studies, lubiprostone doses were based on patients' weight. Efficacy was assessed solely based on Study 1, with a primary endpoint of overall spontaneous bowel movement (SBM) response (increase of ≥1 SBM/week vs baseline and ≥3 SBMs/week for ≥9 weeks, including 3 of the final 4 weeks). RESULTS 606 patients were randomized to treatment (placebo: n=202; lubiprostone: n=404) in Study 1. No statistically significant difference in overall SBM response rate was observed between the lubiprostone and placebo groups (18.5% vs 14.4%; P=.2245). Both the 12-mcg BID and 24-mcg BID doses of lubiprostone were well tolerated in the double-blind and extension phases, with a safety profile consistent with that seen in adult studies. CONCLUSIONS Lubiprostone did not demonstrate statistically significant effectiveness over placebo in children and adolescents with PFC, but did demonstrate a safety profile similar to that in adults.",2021,No statistically significant difference in overall SBM response rate was observed between the lubiprostone and placebo groups (18.5% vs 14.4%; P=.2245).,"['controlled phase (Study 2', 'Pediatric Functional Constipation', '606 patients', 'children and adolescents with PFC', 'patients with PFC (aged 6-17 years']","['lubiprostone 12 mcg twice-daily (BID) and 24 mcg BID', 'placebo', 'lubiprostone, followed by an open-label extension for those who completed the placebo', 'Lubiprostone', 'lubiprostone']","['tolerated', 'Efficacy', 'efficacy and safety', 'overall spontaneous bowel movement (SBM) response', 'overall SBM response rate']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0401146', 'cui_str': 'Constipation - functional'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1684405', 'cui_str': 'lubiprostone'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}]",606.0,0.614228,No statistically significant difference in overall SBM response rate was observed between the lubiprostone and placebo groups (18.5% vs 14.4%; P=.2245).,"[{'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Benninga', 'Affiliation': ""Pediatric Gastroenterologist, Emma Children's Hospital, Amsterdam University Medical Center, Amsterdam, The Netherlands.""}, {'ForeName': 'Sunny Z', 'Initials': 'SZ', 'LastName': 'Hussain', 'Affiliation': 'Senior Consultant, Willis-Knighton Pediatric Gastroenterology & Research, Shreveport, LA, USA.'}, {'ForeName': 'Manu R', 'Initials': 'MR', 'LastName': 'Sood', 'Affiliation': ""Pediatric Gastroenterologist, Division of Pediatric Gastroenterology, Children's Hospital of Wisconsin, Milwaukee, WI, USA.""}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Nurko', 'Affiliation': ""Gastroenterologist, Center for Motility and Functional Gastrointestinal Disorders, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hyman', 'Affiliation': ""Pediatric Gastroenterologist, Children's Hospital, New Orleans, LA, USA.""}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Clifford', 'Affiliation': 'Medical Director, Coastal Pediatric Associates, Charleston, SC, USA.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': ""O'Gorman"", 'Affiliation': ""Pediatric Gastroenterologist, University of Utah and Primary Children's Hospital, Salt Lake City, UT, USA.""}, {'ForeName': 'Taryn', 'Initials': 'T', 'LastName': 'Losch-Beridon', 'Affiliation': 'Vice President, Clinical Development, Sucampo Pharmaceuticals, Inc. (a legal entity of Mallinckrodt Pharmaceuticals), Rockville, MD, USA.'}, {'ForeName': 'Shadreck', 'Initials': 'S', 'LastName': 'Mareya', 'Affiliation': 'Director, Clinical Program Management, Sucampo Pharmaceuticals, Inc. (a legal entity of Mallinckrodt Pharmaceuticals), Rockville, MD, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lichtlen', 'Affiliation': 'Chief Medical Officer, Sucampo AG (a legal entity of Mallinckrodt Pharmaceuticals), Zug, Switzerland.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Di Lorenzo', 'Affiliation': ""Pediatric Gastroenterologist, Division of Pediatric Gastroenterology, Nationwide Children's Hospital, Columbus, OH, USA. Electronic address: Carlo.DiLorenzo@nationwidechildrens.org.""}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2021.04.005'] 3425,33840927,A randomized controlled trial comparing McGRATH series 5 videolaryngoscope with the Macintosh laryngoscope for nasotracheal intubation.,"Background and Aims The aim of this study was to compare the efficacy of McGRATH series 5 videolaryngoscope (VL) with Macintosh laryngoscope for nasotracheal intubation (NTI) in patients without anticipated difficult airways undergoing head and neck cancer surgeries. Material and Methods We randomized 60 adult patients for NTI by experienced anesthetists with either Macintosh laryngoscope or McGRATH series 5 VL (VL group). The primary objective was to compare time taken for intubation (TTI). The secondary objectives included success rates, number of attempts, need for optimization maneuvers, Cormack and Lehane (CL) grade, and percentage of difficult intubations. Results The mean TTI in the VL group was 43 (±10.6) versus 75 (±38.0) s in the Macintosh group (99% CI: 12.5; -51.6 s; P < 0.001). The overall intubation success rate was 100% in both groups. All 29 (100%) patients in the VL group were intubated in the first attempt versus 26 (86%) patients in the Macintosh group (99% CI -5; 33%; P = 0.11). In the Macintosh group, 20 (66%) patients needed optimization maneuver versus none in the VL group (99% CI 40; 91%; P < 0.001). In the VL group, 28 (96%) patients had a CL grade 1 view versus 9 (31%) in Macintosh group (99% CI 38; 92%; P < 0.001). There were no difficult intubations in the VL group versus 3 (10%) in the Macintosh group (99% CI: 7; 28%; P = 0.237). There was no trauma to oropharyngeal structures in either group. Conclusion The McGRATH series 5 VL has faster TTI, better glottic visualization, and less need for optimization maneuvers than the Macintosh laryngoscope for NTI in patients with unanticipated difficult airways, when performed by experienced anesthetists.",2020,There were no difficult intubations in the VL group versus 3 (10%) in the Macintosh group (99% CI: 7; 28%; P = 0.237).,"['60 adult patients for NTI by experienced anesthetists with either Macintosh laryngoscope or McGRATH series 5 VL (VL group', 'patients without anticipated difficult airways undergoing head and neck cancer surgeries']","['Macintosh laryngoscope for nasotracheal intubation', 'McGRATH series 5 videolaryngoscope (VL) with Macintosh laryngoscope for nasotracheal intubation (NTI']","['success rates, number of attempts, need for optimization maneuvers, Cormack and Lehane (CL) grade, and percentage of difficult intubations', 'time taken for intubation (TTI', 'overall intubation success rate', 'mean TTI']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C3164607', 'cui_str': 'Videolaryngoscope'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C3164607', 'cui_str': 'Videolaryngoscope'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0549401', 'cui_str': 'Difficult intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",60.0,0.0355723,There were no difficult intubations in the VL group versus 3 (10%) in the Macintosh group (99% CI: 7; 28%; P = 0.237).,"[{'ForeName': 'Reshma', 'Initials': 'R', 'LastName': 'Ambulkar', 'Affiliation': 'Department of Anaesthesia Critical Care and Pain, Tata Memorial Centre, Dr Ernest Borges Road, Parel, Mumbai, Maharashtra, India.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Ranganathan', 'Affiliation': 'Department of Anaesthesia Critical Care and Pain, Tata Memorial Centre, Dr Ernest Borges Road, Parel, Mumbai, Maharashtra, India.'}, {'ForeName': 'Sukhada', 'Initials': 'S', 'LastName': 'Savarkar', 'Affiliation': 'Department of Anaesthesia Critical Care and Pain, Tata Memorial Centre, Dr Ernest Borges Road, Parel, Mumbai, Maharashtra, India.'}, {'ForeName': 'Jigeeshu V', 'Initials': 'JV', 'LastName': 'Divatia', 'Affiliation': 'Department of Anaesthesia Critical Care and Pain, Tata Memorial Centre, Dr Ernest Borges Road, Parel, Mumbai, Maharashtra, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_1_20'] 3426,33722725,A Novel Low-Cost Exoscopy Station for Training Neurosurgeons and Neurosurgery Trainees.,"BACKGROUND The loss of stereopsis and the need for markedly enhanced hand-eye coordination are obstacles to overcome when performing exoscopic procedures, but both should improve with training. Our objectives were to describe an exoscopy training station and to compare time and performance of a given microsurgical technique among neurosurgery residents and junior neurosurgeons. METHODS We designed a low-cost exoscopy training station featuring a notebook computer, a webcam, and a light-emitting diode source. Surgeons and surgical trainees with no experience in exoscopy were enrolled and divided into 2 groups (trainees and controls). Performance and time in suture placement were evaluated by a skilled observer in both groups at baseline and 3 days later. Between evaluations, trainees completed an exoscopy training module. RESULTS There were 22 participants divided equally into 2 groups. At baseline, trainees had a greater percentage of proper sutures than controls (58% vs. 35%), but they were also slower (32 minutes vs. 25 minutes). On final evaluation, not only were trainees approximately 14 minutes faster than at baseline (P = 0,03), but also their successful suture rate had increased by 18% (final rate 76%, P = 0.02). Moreover, controls were faster compared with baseline by 6 minutes (P = 0.003), but their percentage of successful sutures did not increase (final rate 38%, P = 0.49). The change from baseline to final evaluation favored trainees for both outcomes (P = 0.03 and P = 0.02). CONCLUSIONS Using the exoscopy training station, the trainees were able to improve their time and performance of exoscopy compared with the controls.",2021,"Using the exoscopy training station, the trainees were able to improve their time and performance of exoscopy compared with the controls.","['Surgeons and surgical trainees with no experience in exoscopy', 'neurosurgery residents and junior neurosurgeons', '22 participants divided equally into 2 groups']",[],"['percentage of successful sutures', 'successful suture rate', 'percentage of proper sutures', 'Performance and time in suture placement', 'time and performance of exoscopy']","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0237427', 'cui_str': 'Neurosurgeon'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",22.0,0.0351325,"Using the exoscopy training station, the trainees were able to improve their time and performance of exoscopy compared with the controls.","[{'ForeName': 'Marcos Ezequiel', 'Initials': 'ME', 'LastName': 'Yasuda', 'Affiliation': 'Department of Neurosurgery, Hospital de Clinicas ""Jose de San Martin"", University of Buenos Aires School of Medicine, Buenos Aires, Argentina. Electronic address: ezequielyasuda@gmail.com.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gagliardi', 'Affiliation': 'Spine Unit, Orthopedics Department, Hospital Español de Mendoza, Mendoza, Argentina.'}, {'ForeName': 'Federico Rodriguez', 'Initials': 'FR', 'LastName': 'Cairoli', 'Affiliation': 'Neuropsycopharmacology Unit, Teaching and Research Department, Hospital de Clinicas ""Jose de San Martin"", University of Buenos Aires School of Medicine, Buenos Aires, Argentina.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Renedo', 'Affiliation': 'Department of Neurosurgery, Hospital de Clinicas ""Jose de San Martin"", University of Buenos Aires School of Medicine, Buenos Aires, Argentina.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Iglesias', 'Affiliation': 'Department of Neurosurgery, Hospital de Clinicas ""Jose de San Martin"", University of Buenos Aires School of Medicine, Buenos Aires, Argentina.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Socolovsky', 'Affiliation': 'Department of Neurosurgery, Hospital de Clinicas ""Jose de San Martin"", University of Buenos Aires School of Medicine, Buenos Aires, Argentina.'}]",World neurosurgery,['10.1016/j.wneu.2021.02.126'] 3427,33852013,Diets Varying in Carbohydrate Content Differentially Alter Brain Activity in Homeostatic and Reward Regions in Adults.,"BACKGROUND Obesity has one of the highest refractory rates of all chronic diseases, in part because weight loss induced by calorie restriction, the first-line treatment for obesity, elicits biological adaptations that promote weight regain. Although acute feeding trials suggest a role for macronutrient composition in modifying brain activity related to hunger and satiety, relevance of these findings to weight-loss maintenance has not been studied. OBJECTIVES We investigated effects of weight-loss maintenance diets varying in macronutrient content on regional cerebral blood flow (rCBF) in brain regions involved in hunger and reward. METHODS In conjunction with a randomized controlled feeding trial, we investigated the effects of weight-loss maintenance diets varying in carbohydrate content [high, 60% of total energy: n = 20; 6 men/14 women; mean age: 32.5 y; mean BMI (in kg/m 2): 27.4; moderate, 40% of total energy: n = 22; 10 men/12 women; mean age: 32.5 y; mean BMI: 29.0; low, 20% of total energy: n = 28; 12 men/16 women; mean age: 33.2 y; mean BMI: 27.7] on rCBF in brain regions involved in hunger and reward preprandial and 4 h postprandial after 14-20 wk on the diets. The primary outcome was rCBF in the nucleus accumbens (NAcc) at 4 h postprandial; the secondary outcome was preprandial rCBF in the hypothalamus. RESULTS Consistent with a priori hypothesis, at 4 h postprandial, NAcc rCBF was 43% higher in adults assigned to the high- compared with low-carbohydrate diet {P[family-wise error (FWE)-corrected] < 0.05}. Preprandial hypothalamus rCBF was 41% higher on high-carbohydrate diet [P(FWE-corrected) < 0.001]. Exploratory analyses revealed that elevated rCBF on high-carbohydrate diet was not specific to prandial state: preprandial NAcc rCBF [P(FWE-corrected) < 0.001] and 4 h postprandial rCBF in hypothalamus [P(FWE-corrected) < 0.001]. Insulin secretion predicted differential postprandial activation of the NAcc by diet. CONCLUSIONS We report significant differences in rCBF in adults assigned to diets varying in carbohydrate content for several months, which appear to be partially associated with insulin secretion. These findings suggest that chronic intake of a high-carbohydrate diet may affect brain reward and homeostatic activity in ways that could impede weight-loss maintenance. This trial was registered at clinicaltrials.gov as NCT02300857.",2021,Exploratory analyses revealed that elevated rCBF on high-carbohydrate diet was not specific to prandial state: preprandial NAcc rCBF [P(FWE-corrected) < 0.001] and 4 h postprandial rCBF in hypothalamus [P(FWE-corrected) ,"['Adults', 'carbohydrate content [high, 60% of total energy: n\xa0=\xa020; 6 men/14 women; mean age: 32.5 y; mean BMI (in kg/m 2): 27.4; moderate, 40% of total energy: n\xa0=\xa022; 10 men/12 women; mean age: 32.5 y; mean BMI: 29.0; low, 20% of total energy: n\xa0=\xa028; 12 men/16 women; mean age: 33.2 y; mean BMI: 27.7] on rCBF in brain regions involved in hunger and reward preprandial and 4 h postprandial after 14-20 wk on the diets']","['weight-loss maintenance diets', 'carbohydrate diet']","['regional cerebral blood flow (rCBF', 'rCBF in the nucleus accumbens (NAcc', 'postprandial rCBF in hypothalamus [P(FWE-corrected', 'brain reward and homeostatic activity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439175', 'cui_str': '% of total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517710', 'cui_str': '32.5'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C5192328', 'cui_str': '27.4'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C1273723', 'cui_str': 'Brain region'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C1550738', 'cui_str': 'Before food'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0301577', 'cui_str': 'Carbohydrate diet'}]","[{'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.155153,Exploratory analyses revealed that elevated rCBF on high-carbohydrate diet was not specific to prandial state: preprandial NAcc rCBF [P(FWE-corrected) < 0.001] and 4 h postprandial rCBF in hypothalamus [P(FWE-corrected) ,"[{'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Holsen', 'Affiliation': ""Division of Women's Health and Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'W Scott', 'Initials': 'WS', 'LastName': 'Hoge', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Belinda S', 'Initials': 'BS', 'LastName': 'Lennerz', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Hilâl', 'Initials': 'H', 'LastName': 'Cerit', 'Affiliation': ""Division of Women's Health and Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Taryn', 'Initials': 'T', 'LastName': 'Hye', 'Affiliation': ""Division of Women's Health and Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Moondra', 'Affiliation': ""Division of Women's Health and Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Goldstein', 'Affiliation': ""Division of Women's Health and Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Cara B', 'Initials': 'CB', 'LastName': 'Ebbeling', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Ludwig', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxab090'] 3428,33847325,Dupilumab reduces systemic corticosteroid use and sinonasal surgery rate in CRSwNP.,"BACKGROUND Chronic rhinosinusitis with nasal polyps (CRSwNP) is a type 2 inflammatory disease with a high symptom burden and poor quality of life. Treatment options include recurrent surgeries and/or frequent systemic corticosteroids (SCS). Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin-4 and interleukin-13, key drivers of type 2-mediated inflammation. We report results of pooled analyses from 2 randomised, double-blind, placebo-controlled phase 3 studies (SINUS 24 [NCT02912468]; SINUS-52 [NCT02898454]) to evaluate dupilumab effect versus placebo in adults with CRSwNP with/without SCS use and sinonasal surgery. METHODOLOGY SINUS-24 patients were randomised 1:1 to subcutaneous dupilumab 300 mg (n=143) or placebo (n=133) every 2 weeks (q2w) for 24 weeks. SINUS-52 patients were randomised 1:1:1 to 52 weeks of subcutaneous dupilumab 300 mg q2w (n=150), 24 weeks q2w followed by 28 weeks of dupilumab 300 mg every 4 weeks (n=145) or 52 weeks of placebo q2w (n=153). RESULTS Dupilumab reduced the number of patients undergoing sinonasal surgery (82.6%), the need for in-study SCS use (73.9%), and SCS courses (75.3%). Significant improvements were observed with dupilumab vs placebo regardless of prior sinonasal surgery or SCS use in nasal polyp, nasal congestion, Lund-MacKay, and Sinonasal Outcome Test (22-items) scores, and the University of Pennsylvania Smell Identification Test. CONCLUSIONS Dupilumab demonstrated significant improvements in disease signs and symptoms and reduced the need for sino-nasal surgery and SCS use versus placebo in patients with severe CRSwNP, regardless of SCS use in the previous 2 years, or prior sinonasal surgery.",2021,"Significant improvements were observed with dupilumab vs placebo regardless of prior sinonasal surgery or SCS use in nasal polyp, nasal congestion, Lund-MacKay, and Sinonasal Outcome Test (22-items) scores, and the University of Pennsylvania Smell Identification Test. ","['SINUS-52 patients', 'SINUS-24 patients', 'Chronic rhinosinusitis with nasal polyps (CRSwNP', 'adults with CRSwNP with/without SCS use and sinonasal surgery']","['placebo', 'subcutaneous dupilumab', 'subcutaneous dupilumab 300 mg (n=143) or placebo', 'dupilumab vs placebo']","['recurrent surgeries and/or frequent systemic corticosteroids (SCS', 'disease signs and symptoms', 'number of patients undergoing sinonasal surgery', 'systemic corticosteroid use and sinonasal surgery rate', 'prior sinonasal surgery or SCS use in nasal polyp, nasal congestion, Lund-MacKay, and Sinonasal Outcome Test (22-items) scores, and the University of Pennsylvania Smell Identification Test']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion'}, {'cui': 'C5197689', 'cui_str': 'Sinonasal Outcome Test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.484825,"Significant improvements were observed with dupilumab vs placebo regardless of prior sinonasal surgery or SCS use in nasal polyp, nasal congestion, Lund-MacKay, and Sinonasal Outcome Test (22-items) scores, and the University of Pennsylvania Smell Identification Test. ","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Desrosiers', 'Affiliation': ""Centre de recherche du Centre hospitalier de l'Universite de Montreal (CRCHUM), Montreal, QC, Canada.""}, {'ForeName': 'L P', 'Initials': 'LP', 'LastName': 'Mannent', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Amin', 'Affiliation': 'Regeneron Pharmaceuticals, Inc. Tarrytown, NY, USA.'}, {'ForeName': 'G W', 'Initials': 'GW', 'LastName': 'Canonica', 'Affiliation': 'Regeneron Pharmaceuticals, Inc. Tarrytown, NY, USA.'}, {'ForeName': 'P W', 'Initials': 'PW', 'LastName': 'Hellings', 'Affiliation': 'University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Gevaert', 'Affiliation': 'Ghent University, Ghent, Belgium.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mullol', 'Affiliation': 'Hospital Clínic, IDIBAPS, Universitat de Barcelona, CIBERES, Barcelona, Catalonia, Spain.'}, {'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'Lee', 'Affiliation': 'University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Fujieda', 'Affiliation': 'University of Fukui, Fukui, Japan.'}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Han', 'Affiliation': 'Eastern Virginia Medical School, Norfolk, VA, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hopkins', 'Affiliation': ""Guy's and St Thomas' Hospitals, London, UK.""}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Fokkens', 'Affiliation': 'Academic Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Jankowski', 'Affiliation': 'University Hospital of Nancy, University of Lorraine, Nancy, France.'}, {'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Cho', 'Affiliation': 'University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Mao', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Rice', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Khan', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kamat', 'Affiliation': 'Regeneron Pharmaceuticals, Inc. Tarrytown, NY, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'N M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Inc. Tarrytown, NY, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ruddy', 'Affiliation': 'Regeneron Pharmaceuticals, Inc. Tarrytown, NY, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bachert', 'Affiliation': 'Ghent University, Ghent, Belgium.'}]",Rhinology,['10.4193/Rhin20.415'] 3429,33847224,"Identifying the effective components of a standardized labor induction protocol: secondary analysis of a randomized, controlled trial.","OBJECTIVE Standardized labor induction protocols utilizing evidence-based active management practices are associated with improved obstetric outcomes. However, these protocols are complex and include multiple components. We aimed to identify which of the individual components of an evidence-based labor induction protocol are most associated with reduced rates of cesarean delivery, maternal morbidity, and neonatal morbidity. STUDY DESIGN This is a secondary analysis of a randomized trial comparing time to delivery among four labor induction methods. All patients enrolled in the trial had their labor managed with a multidisciplinary-developed, evidence-based standardized labor induction protocol. For each patient's induction, we assessed adherence to seven components of the protocol. Primary outcomes included cesarean delivery, maternal morbidity, and neonatal morbidity. Bivariate analyses assessed the association of each protocol component with each outcome. Multivariable logistic regression determined independent predictors of each outcome. RESULTS The 491 patients enrolled in the randomized trial were included in this analysis. For cesarean delivery, while adherence to four of the seven protocol components was associated with the outcome in bivariate analyses, only adherence to ""cervical exams should be performed every 1-2 h in active labor"" was associated with reduced cesarean rates when controlling for age, body mass index, and parity. For maternal morbidity, while adherence to ""if misoprostol is utilized, it should not be continued beyond 6 doses or 24 h of use"" was associated in bivariate analysis, it was no longer associated with the outcome in multivariable analysis. Finally, ""cervical exams should be performed every 1-2 h in active labor"" and ""cervical exams should be performed every 2-4 h in latent labor"" were associated with reduced neonatal morbidity both in bivariate analyses as well as when controlling for age, body mass index, and parity. CONCLUSIONS Within a standardized labor induction protocol, adherence to cervical exams every 1-2 h in active labor was associated with reduced cesarean rate, and adherence to cervical exams every 2-4 h in latent labor, as well as every 1-2 h in active labor is associated with reduced neonatal morbidity. Regular cervical examination during labor induction likely allows for intervention when cervical change is not made. This data warrants further investigation into the optimal frequency of cervical exams during labor induction. Furthermore, an understanding of which components of a complex, evidence-based labor induction protocol are most effective may be helpful for streamlining and education around this protocol as implementation occurs across diverse sites.",2021,"For cesarean delivery, while adherence to four of the seven protocol components was associated with the outcome in bivariate analyses, only adherence to ""cervical exams should be performed every 1-2 h in active labor"" was associated with reduced cesarean rates when controlling for age, body mass index, and parity.","['All patients enrolled in the trial had their labor managed with a multidisciplinary-developed, evidence-based standardized labor induction protocol', '491 patients enrolled in the randomized trial']",['misoprostol'],"['reduced cesarean rate, and adherence to cervical exams', 'neonatal morbidity', 'cesarean delivery, maternal morbidity, and neonatal morbidity', 'cesarean rates', 'rates of cesarean delivery, maternal morbidity, and neonatal morbidity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0085174', 'cui_str': 'Misoprostol'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]",491.0,0.210998,"For cesarean delivery, while adherence to four of the seven protocol components was associated with the outcome in bivariate analyses, only adherence to ""cervical exams should be performed every 1-2 h in active labor"" was associated with reduced cesarean rates when controlling for age, body mass index, and parity.","[{'ForeName': 'Rebecca F', 'Initials': 'RF', 'LastName': 'Hamm', 'Affiliation': 'Department of Obstetrics and Gynecology, Maternal and Child Health Research Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Rinad', 'Initials': 'R', 'LastName': 'Beidas', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Sindhu K', 'Initials': 'SK', 'LastName': 'Srinivas', 'Affiliation': 'Department of Obstetrics and Gynecology, Maternal and Child Health Research Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Lisa D', 'Initials': 'LD', 'LastName': 'Levine', 'Affiliation': 'Department of Obstetrics and Gynecology, Maternal and Child Health Research Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2021.1909561'] 3430,33847150,The Effectiveness of Qigong in Managing a Cluster of Symptoms (Breathlessness-Fatigue-Anxiety) in Patients with Lung Cancer: A Randomized Controlled Trial.,"BACKGROUND AND PURPOSE Qigong is used by cancer patients, but its effect is not adequately evaluated to date. The aim of this study was to investigate the effects of Qigong for the management of a symptom cluster comprising fatigue, dyspnea, and anxiety in patients with lung cancer. METHODOLOGY A total of 156 lung cancer patients participated in this trial, and they were randomized to a Qigong group (6 weeks of intervention) or a waitlist control group receiving usual care. The symptom cluster was assessed at baseline, at the end of treatment (primary outcome), and at 12 weeks, alongside measures of cough and quality of life (QOL). RESULTS There was no significant interaction effect between group and time for the symptom cluster overall and for fatigue and anxiety. However, a significant trend towards improvement was observed on fatigue ( P  = .004), dyspnea ( P  = .002), and anxiety ( P  = .049) in the Qigong group from baseline assessment to the end of intervention at the 6th week (within-group changes). Improvements in dyspnea and in the secondary outcomes of cough, global health status, functional well-being and QOL symptom scales were statistically significant between the 2 groups ( P  = .001, .014, .021, .001, and .002, respectively). CONCLUSION Qigong did not alleviate the symptom cluster experience. Nevertheless, this intervention was effective in reducing dyspnea and cough, and improving QOL. More than 6 weeks were needed, however, for detecting the effect of Qigong on improving dyspnea. Furthermore, men benefited more than women. It may not be beneficial to use Qigong to manage the symptom cluster consisting of fatigue, dyspnea, and anxiety, but it may be effective in managing respiratory symptoms (secondary outcomes needing further verification in future research). Future studies targeting symptom clusters should ensure the appropriateness of the combination of symptoms. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02977845. Registered November 30, 2016. https://clinicaltrials.gov/ct2/show/NCT02977845?term=Qigong&cond=Lung+Cancer&draw=2&rank=1.",2021,"Improvements in dyspnea and in the secondary outcomes of cough, global health status, functional well-being and QOL symptom scales were statistically significant between the 2 groups ( P  = .001, .014, .021, .001, and .002, respectively). ","['156 lung cancer patients', 'patients with lung cancer', 'Patients with Lung Cancer', 'cancer patients']","['Qigong', 'waitlist control group receiving usual care']","['dyspnea and cough, and improving QOL', 'anxiety', 'fatigue', 'dyspnea', 'fatigue and anxiety', 'cough, global health status, functional well-being and QOL symptom scales', 'cough and quality of life (QOL']","[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0282077', 'cui_str': 'Qigong'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",156.0,0.285509,"Improvements in dyspnea and in the secondary outcomes of cough, global health status, functional well-being and QOL symptom scales were statistically significant between the 2 groups ( P  = .001, .014, .021, .001, and .002, respectively). ","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Molassiotis', 'Affiliation': 'The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hksar, China.'}, {'ForeName': 'Dau Van', 'Initials': 'DV', 'LastName': 'Vu', 'Affiliation': 'Nam Dinh University of Nursing, Han Thuyen, Nam Dinh, Vietnam.'}, {'ForeName': 'Shirley Siu Yin', 'Initials': 'SSY', 'LastName': 'Ching', 'Affiliation': 'The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hksar, China.'}]",Integrative cancer therapies,['10.1177/15347354211008253'] 3431,33847066,"A prospective randomized clinical trial comparing nepafenac, intravitreal triamcinolone and no adjuvant therapy for epiretinal membrane.","PURPOSE To compare the efficacy of topical nepafenac 0.1% versus intravitreal triamcinolone acetonide (IVTA) at the conclusion of vitrectomy surgery versus no adjuvant therapy (NAT) in improving macular morphology post-operatively in patients undergoing vitrectomy for epiretinal membrane (ERM), as measured by optical coherence tomography (OCT) imaging and best-corrected visual acuity (BCVA). METHODS Design: Prospective randomized clinical trial Setting: Multi-centre 80 patients scheduled to undergo vitrectomy surgery for idiopathic ERM were randomized to receive either IVTA (4 mg/0.1 cc) at the end of surgery, topical nepafenac sodium 0.1% TID for 1 month post-operation or no adjuvant treatment (NAT). Optical coherence tomography (OCT) imaging, best-corrected visual acuity and intraocular pressure (IOP) were measured before surgery, and 1 and 2 months post-operation. RESULTS Although all three groups showed reduction in macular thickness post-operation, the NAT group showed the most improvement, with a reduction of 136.18 ± 29.84 μm at two months. There was no statistically significant difference in macular thickness between the groups at each time point, p = 0.158. The NAT group also had the best recovery in BCVA with an improvement of 0.207 logMAR (10.35 letters) at two months post-operation. There was no statistically significant difference in BCVA between the groups, p = 0.606. There was statistically significant difference in the IOP between the three groups, p = 0.04 only at 1-month visit. The IVTA group had the highest rise in average IOP at both 1 and 2 months post-operation (2.72 and 1.58 mmHg, respectively). CONCLUSION Our study data suggest there was no advantage in the use of topical nepafenac or IVTA for post-vitrectomy ERM surgery.",2021,"There was statistically significant difference in the IOP between the three groups, p = 0.04 only at 1-month visit.","['80 patients scheduled to undergo vitrectomy surgery for idiopathic ERM', 'Design', 'epiretinal membrane', 'patients undergoing vitrectomy for epiretinal membrane (ERM']","['vitrectomy surgery versus no adjuvant therapy (NAT', 'nepafenac, intravitreal triamcinolone and no adjuvant therapy', 'IVTA', 'topical nepafenac', 'intravitreal triamcinolone acetonide (IVTA', 'topical nepafenac sodium 0.1% TID for 1\xa0month post-operation or no adjuvant treatment (NAT', 'topical nepafenac or IVTA']","['BCVA', 'macular thickness', 'Optical coherence tomography (OCT) imaging, best-corrected visual acuity and intraocular pressure (IOP', 'average IOP', 'IOP']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0339543', 'cui_str': 'Epiretinal membrane'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0961209', 'cui_str': 'nepafenac'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}]",80.0,0.133926,"There was statistically significant difference in the IOP between the three groups, p = 0.04 only at 1-month visit.","[{'ForeName': 'Efrem D', 'Initials': 'ED', 'LastName': 'Mandelcorn', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Al-Falah', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Lei Di', 'Initials': 'LD', 'LastName': 'Zhao', 'Affiliation': 'Division of Ophthalmology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kertes', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Devenyi', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Wai-Ching', 'Initials': 'WC', 'LastName': 'Lam', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, ON, Canada.'}]",Acta ophthalmologica,['10.1111/aos.14873'] 3432,33838113,"Voxelotor in adolescents and adults with sickle cell disease (HOPE): long-term follow-up results of an international, randomised, double-blind, placebo-controlled, phase 3 trial.","BACKGROUND For decades, patients with sickle cell disease have had only a limited number of therapies available. In 2019, voxelotor (1500 mg), an oral once-daily sickle haemoglobin polymerisation inhibitor, was approved in the USA for the treatment of sickle cell disease in patients aged 12 years and older on the basis of HOPE trial data. To further describe the applicability of voxelotor as a treatment for this chronic illness, we report the long-term efficacy and safety of this drug at 72 weeks of treatment; the conclusion of the placebo-controlled HOPE trial. METHODS HOPE is an international, randomised, double-blind, placebo-controlled, phase 3 trial done at 60 clinical sites in Canada, Egypt, France, Italy, Jamaica, Kenya, Lebanon, Netherlands, Oman, Turkey, the USA, and the UK. Patients (aged 12-65 years) with confirmed sickle cell disease, a haemoglobin concentration of 5·5-10·5 g/dL at enrolment, and who had between one and ten vaso-occlusive crisis events in the previous 12 months were enrolled. Patients receiving regularly scheduled transfusion therapy, who had received a transfusion in the previous 60 days, or who had been admitted to hospital for a vaso-occlusive crisis in the previous 14 days were excluded. Patients were randomly assigned (1:1:1) to receive either once-daily oral voxelotor 1500 mg, voxelotor 900 mg, or placebo for 72 weeks. Randomisation was done centrally by use of an interactive web response system, stratified by baseline hydroxyurea use (yes vs no), age group (adolescents [12 to <18 years] vs adults [18 to 65 years]), and geographic region (North America vs Europe vs other). The primary endpoint (already reported) was the proportion of patients who achieved a haemoglobin response at week 24. In this final analysis, we report prespecified long-term efficacy assessments by intention to treat, including changes in haemoglobin concentrations from baseline to week 72, changes in the concentration of haemolysis markers (absolute and percentage reticulocytes, indirect bilirubin concentrations, and lactate dehydrogenase concentrations) from baseline to week 72, the annualised incidence of vaso-occlusive crises, and patient functioning, as assessed with the Clinical Global Impression of Change (CGI-C) scale. Safety was assessed in patients who received at least one dose of treatment (modified intention-to-treat population). This trial is registered with ClinicalTrials.gov, NCT03036813. FINDINGS Between Dec 5, 2016, and May 3, 2018, 449 patients were screened, of whom 274 were randomly assigned to the voxelotor 1500 mg group (n=90), the voxelotor 900 mg group (n=92), or the placebo group (n=92). At week 72, the adjusted mean change in haemoglobin concentration from baseline was 1·0 g/dL (95% CI 0·7 to -1·3) in the voxelotor 1500 mg group, 0·5 g/dL (0·3 to -0·8) in the voxelotor 900 mg group, and 0·0 g/dL (-0·3 to 0·3) in the placebo group, with a significant difference observed between the voxelotor 1500 mg group and the placebo group (p<0·0001), and between the voxelotor 900 mg group and the placebo group (p=0·014). Significant improvements in markers of haemolysis, as assessed by the difference in adjusted mean percentage change from baseline at week 72 versus placebo, were observed in the voxelotor 1500 mg group in indirect bilirubin concentrations (-26·6% [95% CI -40·2 to -12·9]) and percentage of reticulocytes (-18·6% [-33·9 to -3·3]). The proportion of patients in the voxelotor 1500 mg group who were rated as ""moderately improved"" or ""very much improved"" at week 72 with the CGI-C was significantly greater than in the placebo group (39 [74%] of 53 vs 24 [47%] of 51; p=0·0057). Serious adverse events unrelated to sickle cell disease were reported in 25 (28%) of 88 patients in the voxelotor 1500 mg group, 20 (22%) of 92 patients in the voxelotor 900 mg group, and 23 (25%) of 91 patients in the placebo group. Grade 3 or 4 adverse events were infrequent (ie, occurred in <10% of patients); anaemia occurred in five or more patients (two [2%] patients in the voxelotor 1500 mg group, seven [8%] patients in the voxelotor 900 mg group, and three [3%] patients in the placebo group). Of all 274 patients, six (2%) deaths occurred during the study (two deaths in each treatment group), all of which were judged as unrelated to treatment. INTERPRETATION Voxelotor 1500 mg resulted in rapid and durable improvements in haemoglobin concentrations maintained over 72 weeks and has potential to address the substantial morbidity associated with haemolytic anaemia in sickle cell disease. FUNDING Global Blood Therapeutics.",2021,"Significant improvements in markers of haemolysis, as assessed by the difference in adjusted mean percentage change from baseline at week 72 versus placebo, were observed in the voxelotor 1500 mg group in indirect bilirubin concentrations (-26·6% [95% CI -40·2 to -12·9]) and percentage of reticulocytes (-18·6% [-33·9 to -3·3]).","['60 clinical sites in Canada, Egypt, France, Italy, Jamaica, Kenya, Lebanon, Netherlands, Oman, Turkey, the USA, and the UK', 'age group (adolescents [12 to <18 years] vs adults [18 to 65 years]), and geographic region (North America vs Europe vs other', 'patients aged 12 years and older on the basis of HOPE trial data', 'patients with sickle cell disease', 'Patients receiving regularly scheduled transfusion therapy, who had received a transfusion in the previous 60 days, or who had been admitted to hospital for a vaso-occlusive crisis in the previous 14 days were excluded', 'Patients (aged 12-65 years) with confirmed sickle cell disease, a haemoglobin concentration of 5·5-10·5 g/dL at enrolment, and who had between one and ten vaso-occlusive crisis events in the previous 12 months were enrolled', '449 patients were screened, of whom 274', '0·5', 'adolescents and adults with sickle cell disease (HOPE']","['voxelotor 1500 mg, voxelotor 900 mg, or placebo', 'voxelotor', 'voxelotor 900 mg group', 'Voxelotor', 'placebo']","['markers of haemolysis', 'anaemia', 'concentration of haemolysis markers (absolute and percentage reticulocytes, indirect bilirubin concentrations, and lactate dehydrogenase concentrations', 'annualised incidence of vaso-occlusive crises, and patient functioning, as assessed with the Clinical Global Impression of Change (CGI-C) scale', 'haemoglobin concentration', 'moderately improved"" or ""very much improved', 'Grade 3 or 4 adverse events', 'deaths', 'haemoglobin concentrations', 'Safety', 'haemoglobin response', 'indirect bilirubin concentrations', 'sickle cell disease']","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0022337', 'cui_str': 'Jamaica'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0023190', 'cui_str': 'Lebanon'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0028971', 'cui_str': 'Oman'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C4723629', 'cui_str': 'voxelotor'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0019054', 'cui_str': 'Haemolysis'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0035286', 'cui_str': 'Reticulocyte'}, {'cui': 'C0301719', 'cui_str': 'Indirect reacting bilirubin'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0442824', 'cui_str': 'Very'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}]",449.0,0.601273,"Significant improvements in markers of haemolysis, as assessed by the difference in adjusted mean percentage change from baseline at week 72 versus placebo, were observed in the voxelotor 1500 mg group in indirect bilirubin concentrations (-26·6% [95% CI -40·2 to -12·9]) and percentage of reticulocytes (-18·6% [-33·9 to -3·3]).","[{'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Howard', 'Affiliation': ""Department of Clinical Haematology, Guy's and St Thomas' NHS Foundation Trust, London, UK. Electronic address: jo.howard@gstt.nhs.uk.""}, {'ForeName': 'Kenneth I', 'Initials': 'KI', 'LastName': 'Ataga', 'Affiliation': 'University of Tennessee Health Science Center at Memphis, Memphis, TN, USA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Brown', 'Affiliation': ""Aflac Cancer and Blood Disorders Center of Children's Healthcare of Atlanta, and Department of Pediatrics, Emory University, Atlanta, GA, USA.""}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Achebe', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Videlis', 'Initials': 'V', 'LastName': 'Nduba', 'Affiliation': 'Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Amal', 'Initials': 'A', 'LastName': 'El-Beshlawy', 'Affiliation': 'Department of Pediatric Hematology, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Hoda', 'Initials': 'H', 'LastName': 'Hassab', 'Affiliation': 'Department of Pediatrics and Clinical Research Center, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Agodoa', 'Affiliation': 'Global Blood Therapeutics, South San Francisco, CA, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Tonda', 'Affiliation': 'Global Blood Therapeutics, South San Francisco, CA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gray', 'Affiliation': 'Global Blood Therapeutics, South San Francisco, CA, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Lehrer-Graiwer', 'Affiliation': 'Global Blood Therapeutics, South San Francisco, CA, USA.'}, {'ForeName': 'Elliott', 'Initials': 'E', 'LastName': 'Vichinsky', 'Affiliation': ""UCSF Benioff Children's Hospital Oakland, Oakland, CA, USA.""}]",The Lancet. Haematology,['10.1016/S2352-3026(21)00059-4'] 3433,33838094,The effects of foot massage on hemodialysis patients' sleep quality and restless leg syndrome: a comparison of lavender and sweet orange essential oil topical application.,"OBJECTIVES Hemodialysis (HD) patients suffer more sleep problems (poor sleep quality and restless leg syndrome [RLS]). Complementary therapy, especially massage with aromatherapy oil is one of the non-pharmacological treatment options with less adverse effects than routine methods. The purpose of this study was to determine the effects of foot massage with of lavender and orange essential oil on HD patients' sleep quality and RLS. METHODS This is a double blind randomized controlled trial on 105 HD patients was conducted at a large educational hospital in Iran, Hamadan province between January and September 2017. Patients divided into three groups with random allocation (35 participants per groups in lavender, orange, and control group). Foot massage during HD with lavender and orange essential oil was administered to the patients three times a week for three weeks, and every massage lasted half an hour. The control group received routine care. Before the intervention, the end of the first, second, and third weeks Pittsburgh Sleep Quality Index (PSQI) and RLS questionnaire were completed for all three groups. Data were statistically analyzed with Independent Samples t-test, chi-square test and repeated-measures analysis of variance (ANOVA) by SPSS version 16. RESULTS The mean score of sleep quality and RLS in the intervention groups were significantly different compare with the control group in all three time of data collecting (p<0 001). CONCLUSIONS Aromatherapy prepared with lavender oil and sweet orange may be recommended to increase sleep quality and RLS level of the HD patients.",2021,"The mean score of sleep quality and RLS in the intervention groups were significantly different compare with the control group in all three time of data collecting (p<0 001). ","['Hemodialysis (HD) patients suffer more sleep problems (poor sleep quality and restless leg syndrome [RLS', ""hemodialysis patients' sleep quality and restless leg syndrome"", '105 HD patients was conducted at a large educational hospital in Iran, Hamadan province between January and September 2017']","['lavender oil and sweet orange', 'lavender and orange essential oil', 'lavender and sweet orange essential oil topical application', 'foot massage', 'aromatherapy oil', 'routine care', 'Foot massage during HD with lavender and orange essential oil']","[""HD patients' sleep quality and RLS"", 'mean score of sleep quality and RLS', 'sleep quality and RLS level', 'Pittsburgh Sleep Quality Index (PSQI) and RLS questionnaire']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0064694', 'cui_str': 'lavender oil'}, {'cui': 'C0522462', 'cui_str': 'Citrus sinensis'}, {'cui': 'C0524903', 'cui_str': 'Lavender'}, {'cui': 'C0440277', 'cui_str': 'Orange - fruit'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",105.0,0.0598122,"The mean score of sleep quality and RLS in the intervention groups were significantly different compare with the control group in all three time of data collecting (p<0 001). ","[{'ForeName': 'Khodayar', 'Initials': 'K', 'LastName': 'Oshvandi', 'Affiliation': 'Mother and Child Care Research Center, Hamadan University of Medical Sciences, P.O. Box: 3614773955, Hamadan, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Mirzajani Letomi', 'Affiliation': 'Student Research Committee, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Ali Reza', 'Initials': 'AR', 'LastName': 'Soltanian', 'Affiliation': 'Modeling of Noncommunicable Disease Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Shamsizadeh', 'Affiliation': 'Mother and Child Care Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2020-0121'] 3434,33838078,Psychosocial Outcomes in Young Adolescents with Type 1 Diabetes Participating in Shared Medical Appointments.,"OBJECTIVE For youth with type 1 diabetes (T1D), the early adolescent period is associated with worsening diabetes management and high rates of negative psychosocial issues, including depressive symptoms and family conflict. Alternative clinical models may help improve both diabetes and psychosocial outcomes. Our study aims to investigate whether Team Clinic, a shared medical appointment model developed specifically for adolescents with T1D, will improve psychosocial outcomes for middle school-aged youth. METHODS Youth with T1D, 11-13 years of age, and their caregivers, participated in a randomized controlled trial comparing Team Clinic to traditional clinic visits (control group). Diabetes characteristics were obtained at every visit. Participants and caregivers completed depression screening and family conflict questionnaires at baseline and end of study. Changes in mean scores on clinical and psychosocial outcomes from baseline to end of study were compared between groups using linear mixed-effects models. RESULTS Eighty-six youth (51% female; 74% White; 10% Hispanic) completed at least one visit during the twelve-month study period. At the end of the study, control group participants reported increases in Emotional Problems compared to Team Clinic participants, including higher levels of Negative Mood/Physical Symptoms (p=0.02). Team Clinic participants reported reduced family conflict surrounding diabetes at study end, compared to control group participants (p=0.03). Caregivers did not report change in depressive symptoms or family conflict during the study. Hemoglobin A1C levels did not change over time in either group. CONCLUSIONS Participation in Team Clinic was associated with improved psychosocial outcomes in middle school-aged participants with T1D. This article is protected by copyright. All rights reserved.",2021,"Team Clinic participants reported reduced family conflict surrounding diabetes at study end, compared to control group participants (p=0.03).","['Youth with T1D, 11-13\u2009years of age, and their caregivers, participated in a randomized controlled trial comparing Team Clinic to traditional clinic visits (control group', 'middle school-aged participants with T1D', 'adolescents with T1D', 'Eighty-six youth (51% female; 74% White; 10% Hispanic', 'Young Adolescents with Type 1 Diabetes Participating in Shared Medical Appointments', 'middle school-aged youth']",[],"['depressive symptoms or family conflict', 'Emotional Problems', 'psychosocial outcomes', 'family conflict surrounding diabetes', 'higher levels of Negative Mood/Physical Symptoms', 'depression screening and family conflict questionnaires', 'Hemoglobin A1C levels', 'Psychosocial Outcomes']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C5197873', 'cui_str': 'Shared Medical Appointments'}]",[],"[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0233542', 'cui_str': 'Family conflict'}, {'cui': 'C0677660', 'cui_str': 'Emotional problems'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1282914', 'cui_str': 'Circumscribed'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0740218', 'cui_str': 'Depression screening'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0474680', 'cui_str': 'Hemoglobin A1c measurement'}]",,0.321358,"Team Clinic participants reported reduced family conflict surrounding diabetes at study end, compared to control group participants (p=0.03).","[{'ForeName': 'Shideh', 'Initials': 'S', 'LastName': 'Majidi', 'Affiliation': 'Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Reid', 'Affiliation': ""Center for Endocrinology, Diabetes, and Metabolism, Children's Hospital Los Angeles, Los Angeles, CA.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Fogel', 'Affiliation': ""Center for Endocrinology, Diabetes, and Metabolism, Children's Hospital Los Angeles, Los Angeles, CA.""}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Anderson', 'Affiliation': ""Baylor College of Medicine/Texas Children's Hospital, Houston, TX.""}, {'ForeName': 'Georgeanna J', 'Initials': 'GJ', 'LastName': 'Klingensmith', 'Affiliation': 'Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Cain', 'Affiliation': 'Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Cari', 'Initials': 'C', 'LastName': 'Berget', 'Affiliation': 'Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Raymond', 'Affiliation': ""Center for Endocrinology, Diabetes, and Metabolism, Children's Hospital Los Angeles, Los Angeles, CA.""}]",Pediatric diabetes,['10.1111/pedi.13212'] 3435,33835414,Psychometric assessment of EQ-5D-5L and ReQoL measures in patients with anxiety and depression: construct validity and responsiveness.,"PURPOSE Generic health measures have been questioned for quantifying mental-health-related outcomes. In patients with anxiety and/or depression, our aim is to assess the psychometric properties of the preference-based EQ-5D-5L (generic health) and ReQoL-UI (recovery-focussed quality of life) for economic evaluation against the PHQ-9 (depression) and GAD-7 (anxiety). EQ-5D-5L anxiety/depression item and ReQoL-10 are also assessed. METHODS A 2:1 (intervention: control) randomised controlled trial collected measures at baseline and 8 weeks post baseline; in the intervention arm, data were also collected 3, 6, 9, and 12-months post baseline. EQ-5D-5L preference-based scores were obtained from the value set for England (VSE) and 'cross-walked' EQ-5D-3L United Kingdom (UK) value set scores. ReQoL-UI preference-based scores were obtained from its UK value set as applied to seven ReQoL-10 items. EQ-5D-5L and ReQoL measures' construct validity and responsiveness were assessed compared against PHQ-9 and GAD-7 scores and group cut-offs. RESULTS 361 people were randomised to intervention (241) or control (120). ReQoL-UI/-10 had better construct validity with depression severity than the EQ-5D-5L (VSE/cross-walk scores), which had relatively better construct validity with anxiety severity than the ReQoL-UI/-10. Across all intervention-arm time-points relative to baseline, responsiveness was generally better for EQ-5D-5L (VSE in particular) than ReQoL-UI, but worse than ReQoL-10. CONCLUSION There is insufficient evidence to recommend the ReQoL-UI over EQ-5D-5L for economic evaluations to capture anxiety severity. However, there may be rationale for recommending the ReQoL-UI over the EQ-5D-5L to capture depression severity given its better construct validity, albeit poorer responsiveness, and if recovery-focussed quality of life relative to condition-specific symptomology is the construct of interest.",2021,"ReQoL-UI/-10 had better construct validity with depression severity than the EQ-5D-5L (VSE/cross-walk scores), which had relatively better construct validity with anxiety severity than the ReQoL-UI/-10.","['patients with anxiety and depression', '361 people', 'patients with anxiety and/or depression']",['ReQoL'],"['PHQ-9 (depression) and GAD-7 (anxiety', 'PHQ-9 and GAD-7 scores', 'EQ-5D-5L anxiety/depression item and ReQoL-10', 'Psychometric assessment of EQ-5D-5L and ReQoL measures', 'EQ-5D-5L preference-based scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",361.0,0.0940417,"ReQoL-UI/-10 had better construct validity with depression severity than the EQ-5D-5L (VSE/cross-walk scores), which had relatively better construct validity with anxiety severity than the ReQoL-UI/-10.","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Franklin', 'Affiliation': 'Health Economics and Decision Science (HEDS), School of Health and Related Research (ScHARR), University of Sheffield, West Court, 1 Mappin Street, Sheffield, S1 4DT, UK. matt.franklin@sheffield.ac.uk.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Enrique', 'Affiliation': 'Cinical Research & Innovation, SilverCloud Health, Dublin, Ireland, UK.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Palacios', 'Affiliation': 'Cinical Research & Innovation, SilverCloud Health, Dublin, Ireland, UK.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Richards', 'Affiliation': 'Cinical Research & Innovation, SilverCloud Health, Dublin, Ireland, UK.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-021-02833-1'] 3436,33834177,"Assessing whether isoniazid is essential during the first 14 days of tuberculosis therapy: a phase 2a, open-label, randomised controlled trial.","Background Clinical studies suggest that isoniazid contributes rapid bacterial killing during the initial two days of tuberculosis treatment but that isoniazid's activity declines significantly after day three. We conducted a 14-day phase IIa open label, randomized trial to assess the essentiality of isoniazid in standard tuberculosis therapy. Methods A total of 69 adults with newly diagnosed sputum-positive tuberculosis from the South African Western Cape region were enrolled and randomized to a four-arm parallel assignment model. Participants were followed for 14 days as inpatients at either the University of Cape Town Lung Institute or at the TASK Applied Science clinical research organization. All arms received standard daily rifampicin, ethambutol, and pyrazinamide but differed as follows: isoniazid only on days one and two (n=17), isoniazid on days one and two then moxifloxacin on days three through 14 (n=16), no isoniazid (n=18), and a control group that received isoniazid for all 14 days (standard therapy, n=18). The primary endpoint was the rate of colony forming unit (CFU) decline during the first 14 days of treatment. Results For 62 participants analyzed, the initial 14-day mean daily fall in log 10 CFU (95% CI) was 0·14 (0·11, 0·18) for participants receiving isoniazid for two days only; 0·13 (0·09, 0·17) for participants receiving isoniazid for two days followed by moxifloxacin; 0·12 (0·08, 0·15) for those not receiving isoniazid; and 0·13 (0·09, 0·16) for the standard therapy group. Conclusions The 14 day EBA for the combination rifampicin, ethambutol, and pyrazinamide was not significantly changed by the addition of isoniazid for the first two days or for the first 14 days of treatment. In a post hoc analysis, significantly higher day-two EBAs were observed for all groups among participants with higher baseline sputum CFUs. Our finding that INH does not contribute to EBA suggests that INH could be replaced with another drug during standard treatment to improve efficacy and decrease rates of resistance to first-line drugs. (Funded by the NIH AIDS Clinical Trial Groups and NIH; A5307 ClinicalTrials.gov number, NCT01589497).",2020,"The 14 day EBA for the combination rifampicin, ethambutol, and pyrazinamide was not significantly changed by the addition of isoniazid for the first two days or for the first 14 days of treatment.","['69 adults with newly diagnosed sputum-positive tuberculosis from the South African Western Cape region', 'Participants were followed for 14 days as inpatients at either the University of Cape Town Lung Institute or at the TASK Applied Science clinical research organization']","['isoniazid', 'no isoniazid', 'moxifloxacin', 'standard daily rifampicin, ethambutol, and pyrazinamide']",['rate of colony forming unit (CFU) decline'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0029237', 'cui_str': 'Organization'}]","[{'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0014964', 'cui_str': 'Ethambutol'}, {'cui': 'C0034239', 'cui_str': 'Pyrazinamide'}]","[{'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]",69.0,0.192109,"The 14 day EBA for the combination rifampicin, ethambutol, and pyrazinamide was not significantly changed by the addition of isoniazid for the first two days or for the first 14 days of treatment.","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Diacon', 'Affiliation': 'Division of Physiology, Department of Medical Biochemistry, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Sachiko', 'Initials': 'S', 'LastName': 'Miyahara', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Rodney', 'Initials': 'R', 'LastName': 'Dawson', 'Affiliation': 'Task Applied Science, Tuberculosis Clinical Research Centre, Bellville, Cape Town, South Africa.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Hogg', 'Affiliation': 'Social & Scientific Systems, Inc., Silver Spring, Maryland, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Donahue', 'Affiliation': 'Frontier Science & Technology Research Foundation Inc., Amherst, New York, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Urbanowski', 'Affiliation': 'Center for TB Research, Department of Medicine, Division of Infectious Diseases, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'De Jager', 'Affiliation': 'Task Applied Science, Tuberculosis Clinical Research Centre, Bellville, Cape Town, South Africa.'}, {'ForeName': 'Courtney V', 'Initials': 'CV', 'LastName': 'Fletcher', 'Affiliation': 'College of Pharmacy, University of Nebraska Medical Center, Omaha, Nebraska.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hafner', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Swindells', 'Affiliation': 'Department of Internal Medicine, Division of Infectious Diseases, College of Medicine, University of Nebraska Medical Center, Omaha, Nebraska.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Bishai', 'Affiliation': 'Center for TB Research, Department of Medicine, Division of Infectious Diseases, Johns Hopkins School of Medicine, Baltimore, Maryland.'}]",The Lancet. Microbe,['10.1016/s2666-5247(20)30011-2'] 3437,33834088,On the Mechanics of Goal Striving: Experimental Evidence of Coasting and Shifting.,"Carver and Scheier's (1990) account of goal striving predicts that unexpectedly fast goal progress leads to reduced effort at that goal (coasting) and to shifting focus toward other goals (shifting). Although these hypotheses are key to this goal-striving account, empirical evidence of coasting and shifting is scarce. Here we demonstrate coasting and shifting in 2 experiments: Participants performed a lexical decision task and were promised a bonus if they delivered a specific number of correct responses (accuracy goal) and a specific number of fast responses (speed goal). After half of the trials, participants received (randomly allocated) feedback on their progress regarding the 2 goals, in which progress toward 1 goal was either above or below the target. In line with hypotheses, better-than-needed progress toward 1 goal led to (a) reduced subsequent progress toward that goal (as reflected in lower goal-related performance; coasting) and (b) a shift of resources toward the alternative goal (as reflected in higher goal-related performance on the alternative goal; shifting). Experiment 1 further demonstrated that positive feedback led to positive affect, and Experiment 2 demonstrated the causal role of affect in coasting and shifting. The implications of the present findings for future research on goal striving are discussed.",2020,"Experiment 1 further demonstrated that positive feedback led to positive affect, and Experiment 2 demonstrated the causal role of affect in coasting and shifting.",[],['lexical decision task'],[],[],[],[],,0.076299,"Experiment 1 further demonstrated that positive feedback led to positive affect, and Experiment 2 demonstrated the causal role of affect in coasting and shifting.","[{'ForeName': 'J Lukas', 'Initials': 'JL', 'LastName': 'Thürmer', 'Affiliation': 'Paris Lodron University Salzburg.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Scheier', 'Affiliation': 'Carnegie Mellon University.'}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Carver', 'Affiliation': 'University of Miami.'}]",Motivation science,['10.1037/mot0000157'] 3438,33832490,Application value of combination therapy of periodontal curettage and root planing on moderate-to-severe chronic periodontitis in patients with type 2 diabetes.,"BACKGROUND Our study attempted to observe the value of periodontal curettage combined with root planing on moderate-to-severe chronic periodontitis in patients with type 2 diabetes. METHODS There involved 72 patients with type 2 diabetes mellitus complicated with moderate-to-severe chronic periodontitis who were diagnosed and treated in our hospital from January 2019 to December 2019. The patients enrolled were randomly divided into four groups using a computer-generated table: root planing and periodontal curettage combined group (n = 18), root planning group (n = 18), periodontal curettage group (n = 18) and cleansing group (n = 18). Blood glucose, plaque index (PI), gingival index (GI), probing depth (PD), attachment loss (AL), serum levels of inflammatory factors (Tumor Necrosis Factor Alpha [TNF- α] and hypersensitive C-reactive protein [hs-CRP]) were observed before and after treatment. The collecting dates were analyzed by the chi-square χ 2 test, repeated measurement analysis of variance, or t-test according to different data types and research objectives. RESULTS Before treatment, there was no significant difference in PI, GI, PD and AL among the four groups (P> 0.05), while after 3-month treatment, the levels of PI, GI, PD and AL in the combined group were lower than those in the root planing group, periodontal curettage group and cleansing group, with both root planing group and periodontal curettage group significantly lower than cleansing group (P< 0.05). The fasting blood glucose, 2-h postprandial blood glucose and glycosylated hemoglobin in the combined group, root planing group, periodontal curettage group and cleansing group were significantly lower than those before treatment (P < 0.05). Before treatment, there was no significant difference in TNF- α and hs-CRP among the four groups (P> 0.05), but the levels of TNF- α and hs-CRP in the four groups decreased significantly after 3-month treatment (P< 0.05). The levels of TNF- α and hs-CRP in the combined group were lower than those in the root planing group, periodontal curettage group and cleansing group, and those in the root planing group and periodontal curettage group were significantly lower than those in the cleansing group (P< 0.05). CONCLUSION The combination therapy of periodontal curettage and root planing exerted beneficial effects on moderate-to-severe chronic periodontitis in patients with type 2 diabetes mellitus, which holds the potential to maintain the level of blood glucose and improve the quality of life of the patients.",2021,"The levels of TNF- α and hs-CRP in the combined group were lower than those in the root planing group, periodontal curettage group and cleansing group, and those in the root planing group and periodontal curettage group were significantly lower than those in the cleansing group (P< 0.05). ","['patients with type 2 diabetes mellitus', '72 patients with type 2 diabetes mellitus complicated with moderate-to-severe chronic periodontitis who were diagnosed and treated in our hospital from January 2019 to December 2019', 'patients with type 2 diabetes']","['root planning group', 'periodontal curettage combined with root planing', 'periodontal curettage group (n = 18) and cleansing group', 'computer-generated table: root planing and periodontal curettage combined group', 'periodontal curettage and root planing']","['moderate-to-severe chronic periodontitis', 'levels of TNF- α and hs-CRP', 'levels of PI, GI, PD and AL', 'fasting blood glucose, 2-h postprandial blood glucose and glycosylated hemoglobin', 'TNF- α and hs-CRP', 'PI, GI, PD and AL', 'Blood glucose, plaque index (PI), gingival index (GI), probing depth (PD), attachment loss (AL), serum levels of inflammatory factors (Tumor Necrosis Factor Alpha [TNF- α] and hypersensitive C-reactive protein [hs-CRP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0010468', 'cui_str': 'Curettage'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0039224', 'cui_str': 'Table'}]","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",72.0,0.0206341,"The levels of TNF- α and hs-CRP in the combined group were lower than those in the root planing group, periodontal curettage group and cleansing group, and those in the root planing group and periodontal curettage group were significantly lower than those in the cleansing group (P< 0.05). ","[{'ForeName': 'Yonghuan', 'Initials': 'Y', 'LastName': 'Bian', 'Affiliation': 'Department of Stomatology, Linyi Central Hospital, Linyi, Shandong, China.'}, {'ForeName': 'Changhao', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': ""Department of Stomatology, Weifang People's Hospital, Weifang, Shandong, China.""}, {'ForeName': 'Zhaojiang', 'Initials': 'Z', 'LastName': 'Fu', 'Affiliation': 'Department of Periodontology, Qingdao Stomatological Hospital, No. 17 Dexian Road, Qingdao, 266000, Shandong, China. fuzhaojiang@126.com.'}]",Head & face medicine,['10.1186/s13005-020-00253-z'] 3439,32184033,Comparison of a glycoprotein E-based ELISA with a varicella-zoster whole-virus ELISA for the quantification of varicella vaccine immune responses in young children.,"Antibody response against varicella-zoster virus (VZV) is frequently assessed by whole-virus- (anti-VZV) or glycoprotein-based ELISAs. This study compared antibody concentrations measured by an assay quantifying anti-VZV glycoprotein E (anti-gE) and anti-VZV ELISA in 12-23-month-olds, receiving two varicella vaccine doses in a phase III trial (NCT02570126). Samples (pre- and 42 days post-each vaccination) initially tested with anti-VZV ELISA were re-tested with anti-gE ELISA. Of 1138 samples from 397 children, 757 were positive by anti-VZV (antibody concentration ≥25 mIU/mL) and 758 by anti-gE ELISA (≥97 mIU/mL). There were 375 double-negative and only 11 discrepant samples. The overall agreement was 99.03% (95% confidence interval: 98.28-99.52; McNemar p-value = 1). The ratio between antibody geometric mean concentrations (anti-gE/anti-VZV) for the 752 double-positive samples was 3.78 overall, 4.75 post-first, and 3.01 post-second vaccination. The anti-gE ELISA is a valid alternative for trials assessing antibody response to new varicella vaccines versus established ones, used as control.",2020,The overall agreement was 99.03% (95% confidence interval: 98.28-99.52; McNemar p-value = 1).,"['young children', 'Of 1138 samples from 397 children, 757 were positive by anti-VZV (antibody concentration ≥25 mIU/mL) and 758 by anti-gE ELISA (≥97 mIU/mL', '12-23-month-olds, receiving two varicella vaccine doses in a phase III trial (NCT02570126']","['glycoprotein E-based ELISA with a varicella-zoster whole-virus ELISA', 'assay quantifying anti-VZV glycoprotein E (anti-gE) and anti-VZV ELISA']","['antibody geometric mean concentrations', 'antibody concentrations', 'Antibody response against varicella-zoster virus (VZV']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0042338', 'cui_str': 'Human herpesvirus 3'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439457', 'cui_str': 'mIU/mL'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0078048', 'cui_str': 'Varicella virus vaccine'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}]","[{'cui': 'C0017968', 'cui_str': 'Glycoprotein'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0740380', 'cui_str': 'Varicella zoster'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0061673', 'cui_str': 'Varicella zoster virus glycoprotein E'}, {'cui': 'C0042338', 'cui_str': 'Human herpesvirus 3'}]","[{'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0042338', 'cui_str': 'Human herpesvirus 3'}]",,0.183552,The overall agreement was 99.03% (95% confidence interval: 98.28-99.52; McNemar p-value = 1).,"[{'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Feyssaguet', 'Affiliation': ""GSK, Rue de l'Institut 89, 1330 Rixensart, Belgium. Electronic address: muriel.m.feyssaguet@gsk.com.""}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Berthold', 'Affiliation': ""GSK, Rue de l'Institut 89, 1330 Rixensart, Belgium. Electronic address: valerie.berthold@gsk.com.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Helle', 'Affiliation': ""GSK, Rue de l'Institut 89, 1330 Rixensart, Belgium. Electronic address: laurent.x.helle@gsk.com.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Povey', 'Affiliation': 'GSK, Av. Fleming 20, 1300 Wavre, Belgium. Electronic address: michael.x.povey@gsk.com.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Ravault', 'Affiliation': ""GSK, Rue de l'Institut 89, 1330 Rixensart, Belgium. Electronic address: stephanie.p.ravault@gsk.com.""}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Carryn', 'Affiliation': ""GSK, Rue de l'Institut 89, 1330 Rixensart, Belgium. Electronic address: stephane.x.carryn@gsk.com.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gillard', 'Affiliation': 'GSK, Av. Fleming 20, 1300 Wavre, Belgium. Electronic address: paul.gillard@gsk.com.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Di Paolo', 'Affiliation': ""GSK, Rue de l'Institut 89, 1330 Rixensart, Belgium. Electronic address: emmanuel.di-paolo@gsk.com.""}]",Vaccine,['10.1016/j.vaccine.2020.03.009'] 3440,33374575,Formulation of Topical Dosage Forms Containing Synthetic and Natural Anti-Inflammatory Agents for the Treatment of Rheumatoid Arthritis.,"Topical anti-inflammatory and analgesic effect for the treatment of rheumatoid arthritis is of major interest because of their fewer side effects compared to oral therapy. The purpose of this study was to prepare different types of topical formulations (ointments and gels) containing synthetic and natural anti-inflammatory agents with different excipients (e.g.,: surfactants, gel-forming) for the treatment of rheumatoid arthritis. The combination of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), diclofenac sodium, a topical analgesic agent methyl salicylate, and a lyophilized extract of Calendula officinalis with antioxidant effect were used in our formulations. The aim was to select the appropriate excipients and dosage form for the formulation in order to enhance the diffusion of active substances and to certify the antioxidant, analgesic, and anti-inflammatory effects of these formulations. To characterize the physicochemical properties of the formulations, rheological studies, and texture profile analysis were carried out. Membrane diffusion and permeability studies were performed with Franz-diffusion method. The therapeutic properties of the formulations have been proven by an antioxidant assay and a randomized prospective study that was carried out on 115 patients with rheumatoid arthritis. The results showed that the treatment with the gel containing diclofenac sodium, methyl salicylate, and lyophilized Calendula officinalis as active ingredients, 2-propenoic acid homopolymer (Synthalen K) as gel-forming excipient, distilled water, triethanolamine, and glycerol had a beneficial analgesic and local anti-inflammatory effect.",2020,"The results showed that the treatment with the gel containing diclofenac sodium, methyl salicylate, and lyophilized Calendula officinalis as active ingredients, 2-propenoic acid homopolymer (Synthalen K) as gel-forming excipient, distilled water, triethanolamine, and glycerol had a beneficial analgesic and local anti-inflammatory effect.","['Rheumatoid Arthritis', '115 patients with rheumatoid arthritis']","['Steroidal Anti-Inflammatory Drugs (NSAIDs), diclofenac sodium', 'topical formulations (ointments and gels) containing synthetic and natural anti-inflammatory agents with different excipients (e.g.,: surfactants, gel-forming', 'diclofenac sodium, methyl salicylate', 'Topical Dosage Forms Containing Synthetic and Natural Anti-Inflammatory Agents']",[],"[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0700583', 'cui_str': 'Diclofenac sodium'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0015237', 'cui_str': 'Pharmaceutical excipient'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0066282', 'cui_str': 'methyl salicylate'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}]",[],115.0,0.0284107,"The results showed that the treatment with the gel containing diclofenac sodium, methyl salicylate, and lyophilized Calendula officinalis as active ingredients, 2-propenoic acid homopolymer (Synthalen K) as gel-forming excipient, distilled water, triethanolamine, and glycerol had a beneficial analgesic and local anti-inflammatory effect.","[{'ForeName': 'Tunde', 'Initials': 'T', 'LastName': 'Jurca', 'Affiliation': 'Department of Pharmacy, Faculty of Medicine and Pharmacy, University of Oradea, 1st December Square 10, 410068 Oradea, Romania.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'Józsa', 'Affiliation': 'Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Debrecen, Nagyerdei Körút 98, 4032 Debrecen, Hungary.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Suciu', 'Affiliation': 'Department of Psychoneuroscience and Rehabilitation Department, Faculty of Medicine and Pharmacy, University of Oradea, 1st December Square 10, 410068 Oradea, Romania.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Pallag', 'Affiliation': 'Department of Pharmacy, Faculty of Medicine and Pharmacy, University of Oradea, 1st December Square 10, 410068 Oradea, Romania.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Marian', 'Affiliation': 'Department of Pharmacy, Faculty of Medicine and Pharmacy, University of Oradea, 1st December Square 10, 410068 Oradea, Romania.'}, {'ForeName': 'Ildikó', 'Initials': 'I', 'LastName': 'Bácskay', 'Affiliation': 'Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Debrecen, Nagyerdei Körút 98, 4032 Debrecen, Hungary.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Mureșan', 'Affiliation': 'Department of Preclinical Disciplines, Faculty of Medicine and Pharmacy, University of Oradea, 1st December Square 10, 410068 Oradea, Romania.'}, {'ForeName': 'Roxana Liana', 'Initials': 'RL', 'LastName': 'Stan', 'Affiliation': 'Department of Pharmaceutical Biochemistry and Clinical Laboratory, Faculty of Pharmacy, University of Medicine and Pharmacy ""Iuliu-Hațieganu"" Victor Babeș Street, 400000 Cluj-Napoca, Romania.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Cevei', 'Affiliation': 'Department of Psychoneuroscience and Rehabilitation Department, Faculty of Medicine and Pharmacy, University of Oradea, 1st December Square 10, 410068 Oradea, Romania.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Cioară', 'Affiliation': 'Department of Psychoneuroscience and Rehabilitation Department, Faculty of Medicine and Pharmacy, University of Oradea, 1st December Square 10, 410068 Oradea, Romania.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Vicaș', 'Affiliation': 'Department of Pharmacy, Faculty of Medicine and Pharmacy, University of Oradea, 1st December Square 10, 410068 Oradea, Romania.'}, {'ForeName': 'Pálma', 'Initials': 'P', 'LastName': 'Fehér', 'Affiliation': 'Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Debrecen, Nagyerdei Körút 98, 4032 Debrecen, Hungary.'}]","Molecules (Basel, Switzerland)",['10.3390/molecules26010024'] 3441,32977595,Dietary Fibres and the Management of Obesity and Metabolic Syndrome: The RESOLVE Study.,"OBJECTIVES This study was performed to evaluate the long-term maintenance of nutritional changes promoted during an intensive initial intervention to induce body weight loss. The ability of these changes to predict long-term health outcomes was also examined. METHODS Nutritional variables, body composition, and metabolic markers collected in the RESOLVE project were analyzed before and after a 3-week intensive diet-exercise intervention (Phase 1), and during a subsequent supervision under free living conditions, of 12 months (Phase 2). RESULTS As expected, the macronutrient composition of the diet was modified to promote a negative energy balance during Phase 1. The decrease in carbohydrates imposed during this phase was maintained during Phase 2 whereas the increase in protein intake returned to baseline values at the end of the program. Dietary fiber intake was almost doubled during Phase 1 and remained significantly greater than baseline values throughout Phase 2. Moreover, fiber intake was the only nutritional variable that systematically and significantly predicted variations of health outcomes in the study. CONCLUSION The adequacy of dietary fiber intake should be a matter of primary consideration in diet-based weight reduction programs.",2020,The decrease in carbohydrates imposed during this phase was maintained during Phase 2 whereas the increase in protein intake returned to baseline values at the end of the program.,['Obesity and Metabolic Syndrome'],['intensive diet-exercise intervention'],"['Dietary fiber intake', 'body weight loss', 'protein intake', 'carbohydrates', 'health outcomes']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0474451', 'cui_str': 'Dietary fiber intake'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0144314,The decrease in carbohydrates imposed during this phase was maintained during Phase 2 whereas the increase in protein intake returned to baseline values at the end of the program.,"[{'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Tremblay', 'Affiliation': 'Institute of Nutrition and Functional Foods (INAF), Université Laval, Quebec City, QC G1V 0A6, Canada.'}, {'ForeName': 'Maëlys', 'Initials': 'M', 'LastName': 'Clinchamps', 'Affiliation': 'Preventive and Occupational Medicine, University Hospital of Clermont-Ferrand, 63000 Clermont-Ferrand, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'Biostatistics, University Hospital of Clermont-Ferrand, 63000 Clermont-Ferrand, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Courteix', 'Affiliation': 'Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Université Clermont Auvergne, 63000 Clermont-Ferrand, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Lesourd', 'Affiliation': 'Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Université Clermont Auvergne, 63000 Clermont-Ferrand, France.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Chapier', 'Affiliation': 'Thermalia Center, 63140 Châtelguyon, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Obert', 'Affiliation': ""Laboratory of Cardiovascular Pharm-ecology (LaPEC EA4278), Université d'Avignon, 84000 Avignon, France.""}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Vinet', 'Affiliation': ""Laboratory of Cardiovascular Pharm-ecology (LaPEC EA4278), Université d'Avignon, 84000 Avignon, France.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Walther', 'Affiliation': ""Laboratory of Cardiovascular Pharm-ecology (LaPEC EA4278), Université d'Avignon, 84000 Avignon, France.""}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Chaplais', 'Affiliation': 'Laboratory ""Development, Adaption and Disability"" (DevAH-EA 3450), Université de Lorraine, 54000 Nancy, France.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Department of Exercise Physiology, University of Isfahan, Isfahan 81746-73441, Iran.'}, {'ForeName': 'Julien S', 'Initials': 'JS', 'LastName': 'Baker', 'Affiliation': 'Centre for Health and Exercise Science Research, Department of Sport, Physical Education and Health, Hong Kong Baptist University, Kowloon Tong 999077, Hong Kong.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thivel', 'Affiliation': 'Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Université Clermont Auvergne, 63000 Clermont-Ferrand, France.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Drapeau', 'Affiliation': 'Institute of Nutrition and Functional Foods (INAF), Université Laval, Quebec City, QC G1V 0A6, Canada.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Dutheil', 'Affiliation': 'Preventive and Occupational Medicine, University Hospital of Clermont-Ferrand, 63000 Clermont-Ferrand, France.'}]",Nutrients,['10.3390/nu12102911'] 3442,33746101,C-Arm-Free Anterior Correction for Adolescent Idiopathic Scoliosis (Lenke Type 5C): Analysis of Early Outcomes and Complications.,"BACKGROUND Computer-assisted spinal surgery as a technique for reducing radiation exposure to the operating staff and the complications of spinal deformity are receiving considerable attention. However, no technical reports have described the technique for navigating anterior correction of adolescent idiopathic scoliosis without C-arm fluoroscopy. The purpose of this study was to evaluate the efficacy and safety of this new C-arm-free anterior correction for scoliosis. METHODS This study investigated 38 consecutive patients with Lenke type 5C curves who underwent selective lumbar or thoracolumbar fusion, comprising 26 patients with conventional anterior correction surgery, and 12 patients with C-arm-free navigation surgery. The 2 groups were evaluated immediately postoperatively and at the 2-year follow-up. RESULTS No vascular injuries, screw malpositioning, or major complications were associated with the surgical procedure in either group. Correction rates of the lumbar curve were satisfactory with no significant difference between groups (mean, 82.6% ± 5.7% vs. 80.7% ± 10.2%, respectively). However, mean time for fluoroscopy in group C was 133 ± 9.5 seconds (P < 0.0001). No significant differences in intraoperative blood loss (642 ± 123 mL vs. 731 ± 222 mL, respectively) or surgical time (251 ± 13 min vs. 301 ± 38 min, respectively) were seen between groups. Mean final follow-up Scoliosis Research Society Outcomes Questionnaire (SRS-22) was also excellent for both group C (4.2 ± 0.19) and group N (4.3 ± 0.20). CONCLUSIONS C-arm-free anterior correction offers safe, effective surgery for adolescent idiopathic scoliosis. The advantage of this new technique is no radiation exposure for medical staff at centers performing large numbers of spinal procedures.",2021,"Mean final follow-up Scoliosis Research Society Outcomes Questionnaire (SRS-22) was also excellent for both group C (4.2 ± 0.19) and group N (4.3 ± 0.20). ","['Adolescent Idiopathic Scoliosis', 'Lenke Type 5C', '38 consecutive patients with Lenke type 5C curves who underwent selective lumbar or thoracolumbar fusion, comprising 26 patients with', 'adolescent idiopathic scoliosis']","['C-Arm-Free Anterior Correction', 'C-arm-free anterior correction', 'conventional anterior correction surgery, and 12 patients with C-arm-free navigation surgery', 'new C-arm-free anterior correction']","['Correction rates of the lumbar curve', 'Mean final follow-up Scoliosis Research Society Outcomes Questionnaire (SRS-22', 'efficacy and safety', 'mean time for fluoroscopy', 'vascular injuries, screw malpositioning, or major complications', 'surgical time', 'intraoperative blood loss']","[{'cui': 'C0410702', 'cui_str': 'Adolescent idiopathic scoliosis'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}]","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0036439', 'cui_str': 'Scoliosis deformity of spine'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175693', 'cui_str': 'Russell-Silver syndrome'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0178324', 'cui_str': 'Injury of blood vessel'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",26.0,0.0334039,"Mean final follow-up Scoliosis Research Society Outcomes Questionnaire (SRS-22) was also excellent for both group C (4.2 ± 0.19) and group N (4.3 ± 0.20). ","[{'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Tanaka', 'Affiliation': 'Department of Orthopaedic Surgery, Okayama Rosai Hospital, Okayama, Japan. Electronic address: tanaka0896@gmail.com.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Orthopaedic Surgery, Okayama Rosai Hospital, Okayama, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Uotani', 'Affiliation': 'Department of Orthopaedic Surgery, Okayama Rosai Hospital, Okayama, Japan.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Yamauchi', 'Affiliation': 'Department of Orthopaedic Surgery, Okayama Rosai Hospital, Okayama, Japan.'}, {'ForeName': 'Hauo', 'Initials': 'H', 'LastName': 'Misawa', 'Affiliation': 'Department of Orthopaedic Surgery, Okayama University Hospital, Okayama, Japan.'}]",World neurosurgery,['10.1016/j.wneu.2021.03.060'] 3443,33819910,Assessment of the Effectiveness of Identity-Based Public Health Announcements in Increasing the Likelihood of Complying With COVID-19 Guidelines: Randomized Controlled Cross-sectional Web-Based Study.,"BACKGROUND Public health campaigns aimed at curbing the spread of COVID-19 are important in reducing disease transmission, but traditional information-based campaigns have received unexpectedly extreme backlash. OBJECTIVE This study aimed to investigate whether customizing of public service announcements (PSAs) providing health guidelines to match individuals' identities increases their compliance. METHODS We conducted a within- and between-subjects, randomized controlled cross-sectional, web-based study in July 2020. Participants viewed two PSAs: one advocating wearing a mask in public settings and one advocating staying at home. The control PSA only provided information, and the treatment PSAs were designed to appeal to the identities held by individuals; that is, either a Christian identity or an economically motivated identity. Participants were asked about their identity and then provided a control PSA and treatment PSA matching their identity, in random order. The PSAs were of approximately 100 words. RESULTS We recruited 300 social media users from Amazon Mechanical Turk in accordance with usual protocols to ensure data quality. In total, 8 failed the data quality checks, and the remaining 292 were included in the analysis. In the identity-based PSA, the source of the PSA was changed, and a phrase of approximately 12 words relevant to the individual's identity was inserted. A PSA tailored for Christians, when matched with a Christian identity, increased the likelihood of compliance by 12 percentage points. A PSA that focused on economic values, when shown to individuals who identified as economically motivated, increased the likelihood of compliance by 6 points. CONCLUSIONS Using social media to deliver COVID-19 public health announcements customized to individuals' identities is a promising measure to increase compliance with public health guidelines. TRIAL REGISTRATION ISRCTN Registry 22331899; https://www.isrctn.com/ISRCTN22331899.",2021,"A PSA tailored for Christians, when matched with a Christian identity, increased the likelihood of compliance by 12 percentage points.","['Complying With COVID-19 Guidelines', '300 social media users from Amazon Mechanical Turk in accordance with usual protocols to ensure data quality']","['advocating wearing a mask in public settings and one advocating staying at home', 'public service announcements (PSAs']",[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0337911', 'cui_str': 'Turks'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0242483', 'cui_str': 'Data Quality'}]","[{'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0687688', 'cui_str': 'Public Service Announcements'}]",[],300.0,0.0592323,"A PSA tailored for Christians, when matched with a Christian identity, increased the likelihood of compliance by 12 percentage points.","[{'ForeName': 'Alexander S', 'Initials': 'AS', 'LastName': 'Dennis', 'Affiliation': 'Smith School of Business, University of Maryland, College Park, MD, United States.'}, {'ForeName': 'Patricia L', 'Initials': 'PL', 'LastName': 'Moravec', 'Affiliation': 'McCombs School of Business, University of Texas at Austin, Austin, TX, United States.'}, {'ForeName': 'Antino', 'Initials': 'A', 'LastName': 'Kim', 'Affiliation': 'Kelley School of Business, Indiana University, Bloomington, IN, United States.'}, {'ForeName': 'Alan R', 'Initials': 'AR', 'LastName': 'Dennis', 'Affiliation': 'Kelley School of Business, Indiana University, Bloomington, IN, United States.'}]",JMIR public health and surveillance,['10.2196/25762'] 3444,33839277,"Detection of colorectal neoplasms using linked color imaging: A prospective, randomized, tandem colonoscopy trial.","BACKGROUND AND AIMS A higher adenoma detection rate (ADR) has been shown to be related to a lower incidence and mortality of colorectal cancer. We analyzed the efficacy of linked color imaging (LCI) by assessing the detection, miss, and visibility of various featured adenomas as compared with white light imaging (WLI). METHODS This was a prospective, randomized, tandem trial. The participants were randomly assigned to two groups: first observation by LCI, then second observation by WLI (LCI group); or both observations by WLI (WLI group). Suspected neoplastic lesions were resected after magnifying image-enhanced endoscopy. The primary outcome was to compare the ADR during the first observation. Secondary outcomes included evaluation of adenoma miss rate (AMR) and visibility score. RESULTS Seven-hundred eighty patients were randomized, 700 of whom were included in the final analysis. The ADR was 69.6% and 63.2% in the LCI and WLI groups, respectively, with no significant difference. However, LCI improved the average ADR in low-detectors compared to high-detectors (76.0% vs 55.1%; P < 0.001). Total AMR was 20.6% in the LCI group, which was significantly lower than that in the WLI group (31.1%) (P < 0.001). AMR in the LCI group was significantly lower, especially for diminutive adenomas (23.4% vs 35.1%; P < 0.001) and non-polypoid lesions (25.6% vs 37.9%; P < 0.001) compared to the WLI group. CONCLUSION Although both methods provided a similar ADR, LCI had a lower AMR than WLI. LCI could benefit endoscopists with lower ADR, an observation that warrants additional study.",2021,"AMR in the LCI group was significantly lower, especially for diminutive adenomas (23.4% vs 35.1%; P < 0.001) and non-polypoid lesions (25.6% vs 37.9%; P < 0.001) compared to the WLI group. ","['Seven-hundred eighty patients were randomized, 700 of whom were included in the final analysis']","['LCI, then second observation by WLI (LCI group); or both observations by WLI (WLI group', 'LCI', 'white light imaging (WLI', 'linked color imaging (LCI']","['diminutive adenomas', 'AMR', 'non-polypoid lesions', 'Total AMR', 'ADR', 'evaluation of adenoma miss rate (AMR) and visibility score']","[{'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",780.0,0.0916491,"AMR in the LCI group was significantly lower, especially for diminutive adenomas (23.4% vs 35.1%; P < 0.001) and non-polypoid lesions (25.6% vs 37.9%; P < 0.001) compared to the WLI group. ","[{'ForeName': 'Issei', 'Initials': 'I', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Yamamura', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan. Electronic address: tyamamu@med.nagoya-u.ac.jp.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Maeda', 'Affiliation': 'Department of Endoscopy, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Tsunaki', 'Initials': 'T', 'LastName': 'Sawada', 'Affiliation': 'Department of Endoscopy, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Mizutani', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Eri', 'Initials': 'E', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Kakushima', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Furukawa', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Eizaburo', 'Initials': 'E', 'LastName': 'Ohno', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Kawashima', 'Affiliation': 'Department of Endoscopy, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Masanao', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Fujishiro', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2021.04.004'] 3445,33839207,Establishment and validation of a prognostic nomogram to predict early metastasis in nasopharyngeal carcinoma patients within six months after radiotherapy and to guide intensive treatment.,"PURPOSE This study aimed to establish an effective prognostic nomogram to predict the risk of early metastasis (EM) in nasopharyngeal carcinoma (NPC) patients, as a guide for intensive treatment. MATERIALS AND METHODS A total of 9021 patients with biopsy-confirmed NPC at our institute were enrolled in this study between December 2006 to December 2016. We randomized these patients using a proportion of 2/3 and 1/3 and selected 6044 and 2977 patients as the training and validation cohorts, respectively. All patients received radiotherapy with or without chemotherapy. Univariate and multivariate logistical regressions were used to identify independent risk factors. The nomogram's predictive value was evaluated by concordance indexes (C-indexes), calibration curves, probability density functions (PDFs), and clinical utility curves (CUCs). ROC analysis using Delong test was used to compare efficiency between the nomogram and other risk factors. RESULTS In total, 174 (2.9%) and 81 (2.7%) patients in training and validation cohorts, respectively, had EM. Pretreatment plasma EBV DNA, N stage, LDH, ALP, BMI, and sex were independent predictive factors of EM. The C-indexes of nomogram were 0.756 (95% CI=0.719-0.793) and 0.766 (95% CI=0.720-0.813), in the training and validation cohorts, respectively. The C-index of the nomogram was significantly superior to any one of independent factors. According to the PDFs and CUCs and considering the balance of the true positive EM patients and true positive non-EM patients, we chose 5.0% as a threshold probability for clinical decision-making, which could distinguish about 85% and 48% of non-EM and EM patients, respectively. CONCLUSION Our nomogram had good accuracy in predicting EM incidence, and a 5.0% threshold was appropriate for clinical decision-making.",2021,"The nomogram's predictive value was evaluated by concordance indexes (C-indexes), calibration curves, probability density functions (PDFs), and clinical utility curves (CUCs).","['nasopharyngeal carcinoma (NPC) patients', 'nasopharyngeal carcinoma patients within six months after', 'patients using a proportion of 2/3 and 1/3 and selected 6044 and 2977 patients as the training and validation cohorts, respectively', '9021 patients with biopsy-confirmed NPC at our institute were enrolled in this study between December 2006 to December 2016']","['radiotherapy with or without chemotherapy', 'radiotherapy']","['Pretreatment plasma EBV DNA, N stage, LDH, ALP, BMI, and sex', 'concordance indexes (C-indexes), calibration curves, probability density functions (PDFs), and clinical utility curves (CUCs']","[{'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0369169', 'cui_str': 'Epstein-Barr virus DNA'}, {'cui': 'C0456532', 'cui_str': 'N category'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0006751', 'cui_str': 'Calibration'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",9021.0,0.0161033,"The nomogram's predictive value was evaluated by concordance indexes (C-indexes), calibration curves, probability density functions (PDFs), and clinical utility curves (CUCs).","[{'ForeName': 'Zi-Jian', 'Initials': 'ZJ', 'LastName': 'Lu', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: luzj@sysucc.org.cn.'}, {'ForeName': 'Li-Ting', 'Initials': 'LT', 'LastName': 'Liu', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: liult@sysucc.org.cn.'}, {'ForeName': 'Xue-Song', 'Initials': 'XS', 'LastName': 'Sun', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: sunxs@sysucc.org.cn.'}, {'ForeName': 'Shan-Shan', 'Initials': 'SS', 'LastName': 'Guo', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: guoshsh@sysucc.org.cn.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: yangqi@sysucc.org.cn.'}, {'ForeName': 'Sai-Lan', 'Initials': 'SL', 'LastName': 'Liu', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: liusl@sysucc.org.cn.'}, {'ForeName': 'Xiao-Yun', 'Initials': 'XY', 'LastName': 'Li', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: lixy1@sysucc.org.cn.'}, {'ForeName': 'Hui-Zhi', 'Initials': 'HZ', 'LastName': 'Qiu', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: qiuhz@sysucc.org.cn.'}, {'ForeName': 'Zhen-Chong', 'Initials': 'ZC', 'LastName': 'Yang', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: yangzc@sysucc.org.cn.'}, {'ForeName': 'Bei-Bei', 'Initials': 'BB', 'LastName': 'Xiao', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: xiaobb@sysucc.org.cn.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Lin', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: linchao@sysucc.org.cn.'}, {'ForeName': 'Dong-Hua', 'Initials': 'DH', 'LastName': 'Luo', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: luodh@sysucc.org.cn.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Sun', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: sunrui@sysucc.org.cn.'}, {'ForeName': 'Huan-Xin', 'Initials': 'HX', 'LastName': 'Lin', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, PR China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou 510060, PR China. Electronic address: linhx@sysucc.org.cn.'}, {'ForeName': 'Qiu-Yan', 'Initials': 'QY', 'LastName': 'Chen', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: chenqy@sysucc.org.cn.'}, {'ForeName': 'Lin-Quan', 'Initials': 'LQ', 'LastName': 'Tang', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: tanglq@sysucc.org.cn.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: guoling@sysucc.org.cn.'}, {'ForeName': 'Hai-Qiang', 'Initials': 'HQ', 'LastName': 'Mai', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: maihq@sysucc.org.cn.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2021.03.035'] 3446,33846472,Prediction of ambulatory outcome in patients with corona radiata infarction using deep learning.,"Deep learning (DL) is an advanced machine learning approach used in diverse areas such as bioinformatics, image analysis, and natural language processing. Here, using brain magnetic resonance imaging (MRI) data obtained at early stages of infarcts, we attempted to develop a convolutional neural network (CNN) to predict the ambulatory outcome of corona radiata infarction at six months after onset. We retrospectively recruited 221 patients with corona radiata infarcts. A favorable outcome of ambulatory function was defined as a functional ambulation category (FAC) score of ≥ 4 (able to walk without a guardian's assistance), and a poor outcome of ambulatory function was defined as an FAC score of < 4. We used a CNN algorithm. Of the included subjects, 69.7% (n = 154) were assigned randomly to the training set and the remaining 30.3% (n = 67) were assigned to the validation set to measure the model performance. The area under the curve was 0.751 (95% CI 0.649-0.852) for the prediction of ambulatory function with the validation dataset using the CNN model. We demonstrated that a CNN model trained using brain MRIs captured at an early stage after corona radiata infarction could be helpful in predicting long-term ambulatory outcomes.",2021,The area under the curve was 0.751 (95% CI 0.649-0.852) for the prediction of ambulatory function with the validation dataset using the CNN model.,"['Of the included subjects, 69.7% (n\u2009=\u2009154', 'patients with corona radiata infarction using deep learning', '221 patients with corona radiata infarcts']",['Deep learning (DL'],"[""functional ambulation category (FAC) score of ≥\u20094 (able to walk without a guardian's assistance"", 'ambulatory function']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4728193', 'cui_str': 'Corona radiata infarction'}, {'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}]","[{'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2712089', 'cui_str': 'Able to walk'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",221.0,0.0689611,The area under the curve was 0.751 (95% CI 0.649-0.852) for the prediction of ambulatory function with the validation dataset using the CNN model.,"[{'ForeName': 'Jeoung Kun', 'Initials': 'JK', 'LastName': 'Kim', 'Affiliation': 'Department of Business Administration, School of Business, Yeungnam University, Gyeongsan-si, Republic of Korea.'}, {'ForeName': 'Yoo Jin', 'Initials': 'YJ', 'LastName': 'Choo', 'Affiliation': 'Department of Rehabilitation Medicine, College of Medicine, Yeungnam University, 317-1, Daemyungdong, Namku, Taegu, 705-717, Republic of Korea.'}, {'ForeName': 'Hyunkwang', 'Initials': 'H', 'LastName': 'Shin', 'Affiliation': 'Department of Information and Communication Engineering, Yeungnam University, Gyeongsan-si, Republic of Korea.'}, {'ForeName': 'Gyu Sang', 'Initials': 'GS', 'LastName': 'Choi', 'Affiliation': 'Department of Information and Communication Engineering, Yeungnam University, Gyeongsan-si, Republic of Korea.'}, {'ForeName': 'Min Cheol', 'Initials': 'MC', 'LastName': 'Chang', 'Affiliation': 'Department of Rehabilitation Medicine, College of Medicine, Yeungnam University, 317-1, Daemyungdong, Namku, Taegu, 705-717, Republic of Korea. wheel633@gmail.com.'}]",Scientific reports,['10.1038/s41598-021-87176-0'] 3447,33846214,Effects of message framing on cervical cancer screening knowledge and intentions related to primary HPV testing.,"Numerous national guidelines now include primary human papillomavirus (HPV) testing as a recommended screening option for cervical cancer in the United States yet little is known regarding screening intentions for this specific screening strategy or interventions that may increase uptake. Gain- and loss-framed messaging can positively impact health behaviors; however, there is mixed evidence on which is more effective for cervical cancer screening, with no published evidence examining HPV testing. To help address this gap, this study compared the effects of message framing on screening knowledge and intentions related to primary HPV testing. We randomized females aged 21-65 (n=365) to receive brief messaging about cervical cancer screening with either gain- or loss-framing. In January-February 2020, participants completed pretest and posttest measures evaluating cervical cancer knowledge, beliefs, and intentions to be screened using HPV testing. We used generalized estimating equations to model message and framing effects on screening outcomes, controlling for age, education, race, and baseline measures. In comparison to pretest, messaging significantly increased HPV-related screening intentions [aOR: 2.4 (1., 3.5)] and knowledge [aOR: 1.7 (1.2, 2.4)], perceived effectiveness of HPV testing [aOR: 4.3 (2.8, 6.5)], and preference for primary HPV screening [aOR: 3.2 (1.2, 8.5), regardless of message framing. For all outcomes, no significant interaction by message framing was observed. Brief public health messaging positively impacted HPV-related screening intentions, knowledge, and beliefs, independent of message framing. In conjunction with other strategies, these results suggest that messaging could be an effective tool to increase uptake of primary HPV testing.",2021,"In comparison to pretest, messaging significantly increased HPV-related screening intentions [aOR: 2.4 (1., 3.5)] and knowledge [aOR: 1.7 (1.2, 2.4)], perceived effectiveness of HPV testing [aOR: 4.3 (2.8, 6.5)], and preference for primary HPV screening [aOR: 3.2 (1.2, 8.5), regardless of message framing.",['females aged 21-65 (n=365) to receive'],"['brief messaging about cervical cancer screening with either gain- or loss-framing', 'Gain- and loss-framed messaging']","['HPV-related screening intentions', 'cervical cancer knowledge, beliefs, and intentions to be screened using HPV testing']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}]","[{'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]",,0.0377657,"In comparison to pretest, messaging significantly increased HPV-related screening intentions [aOR: 2.4 (1., 3.5)] and knowledge [aOR: 1.7 (1.2, 2.4)], perceived effectiveness of HPV testing [aOR: 4.3 (2.8, 6.5)], and preference for primary HPV screening [aOR: 3.2 (1.2, 8.5), regardless of message framing.","[{'ForeName': 'Shannon N', 'Initials': 'SN', 'LastName': 'Ogden', 'Affiliation': 'Health Law, Policy & Management, Boston University School of Public Health.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Leskinen', 'Affiliation': 'Social Science, Ramapo College School of Social Science and Human Services.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Sarma', 'Affiliation': 'Division of Cancer Control and Population Sciences, National Cancer Institute.'}, {'ForeName': 'Jocelyn V', 'Initials': 'JV', 'LastName': 'Wainwright', 'Affiliation': 'Family Medicine and Community Health, Perelman School of Medicine at the University of Pennsylvania.'}, {'ForeName': 'Katharine A', 'Initials': 'KA', 'LastName': 'Rendle', 'Affiliation': 'Perelman School of Medicine, Department of Family Medicine & Community Health, University of Pennsylvania katharine.rendle@pennmedicine.upenn.edu.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-20-0622'] 3448,33846198,FDA Approval Summary: Pembrolizumab for the first-line treatment of patients with MSI-H/dMMR advanced unresectable or metastatic colorectal carcinoma.,"The Food and Drug Administration (FDA) approved pembrolizumab on June 29, 2020, for the treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) colorectal cancer (CRC) with no prior systemic treatment for advanced disease. The approval was based on data from Study Keynote-177, which randomly allocated patients to receive either pembrolizumab or standard of care (SOC) with chemotherapy. Overall survival (OS) and independently-assessed progression free survival (PFS) were the primary endpoints. At the time of the final PFS analysis and second pre-specified interim OS analysis, the estimated median PFS was 16.5 months (95% CI: 5.4, 32.4) vs. 8.2 months (95% CI: 6.1, 10.2) in the pembrolizumab and SOC arms, respectively (Hazard Ratio [HR]: 0.60 (95% CI: 0.45, 0.80; two-sided p-value= 0.0004)). FDA assessed unblinded OS data during the review of the application and identified no safety concerns that would preclude approval of this supplement. Adverse reactions occurring in >30% of patients receiving pembrolizumab were diarrhea, fatigue/asthenia, and nausea. Adverse reactions occurring in >30% of patients receiving SOC were diarrhea, nausea, fatigue/asthenia, neutropenia, decreased appetite, peripheral neuropathy (high-level term), vomiting, abdominal pain, constipation, and stomatitis. Duration of treatment in the pembrolizumab arm was almost double (median 11.1 months, range 0-30.6 months) than the duration of treatment in patients receiving SOC (median 5.7 months). Approval of pembrolizumab is likely to change the treatment paradigm for 1st line treatment with MSI-H advanced CRC given the study results and different safety profile.",2021,"Adverse reactions occurring in >30% of patients receiving SOC were diarrhea, nausea, fatigue/asthenia, neutropenia, decreased appetite, peripheral neuropathy (high-level term), vomiting, abdominal pain, constipation, and stomatitis.","['patients with unresectable or metastatic microsatellite instability-high (MSI-H) colorectal cancer (CRC) with no prior systemic treatment for advanced disease', 'patients with MSI-H/dMMR advanced unresectable or metastatic colorectal carcinoma']","['pembrolizumab or standard of care (SOC) with chemotherapy', 'pembrolizumab', 'Pembrolizumab']","['Overall survival (OS) and independently-assessed progression free survival (PFS', 'median PFS', 'diarrhea, nausea, fatigue/asthenia, neutropenia, decreased appetite, peripheral neuropathy (high-level term), vomiting, abdominal pain, constipation, and stomatitis', 'diarrhea, fatigue/asthenia, and nausea', 'Adverse reactions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0796369', 'cui_str': 'Microsatellite instability'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",,0.234237,"Adverse reactions occurring in >30% of patients receiving SOC were diarrhea, nausea, fatigue/asthenia, neutropenia, decreased appetite, peripheral neuropathy (high-level term), vomiting, abdominal pain, constipation, and stomatitis.","[{'ForeName': 'Sandra J', 'Initials': 'SJ', 'LastName': 'Casak', 'Affiliation': 'Office of Oncologic Diseases, United States Food and Drug Administration sandra.casak@fda.hhs.gov.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Marcus', 'Affiliation': 'Office of Oncologic Diseases, United States Food and Drug Administration.'}, {'ForeName': 'Lola', 'Initials': 'L', 'LastName': 'Fashoyin-Aje', 'Affiliation': 'Office of Oncologic Diseases, United States Food and Drug Administration.'}, {'ForeName': 'Sirisha L', 'Initials': 'SL', 'LastName': 'Mushti', 'Affiliation': 'Office of Biostatistics, United States Food and Drug Administration.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'Office of Clinical Pharmacology, United States Food and Drug Administration.'}, {'ForeName': 'Yuan Li', 'Initials': 'YL', 'LastName': 'Shen', 'Affiliation': 'Office of Biostatistics, United States Food and Drug Administration.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Pierce', 'Affiliation': 'Office of Oncology Diseases, Food and Drug Administration.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Her', 'Affiliation': 'Office of Hematology and Oncology Products, United States Food and Drug Administration.'}, {'ForeName': 'Kirsten B', 'Initials': 'KB', 'LastName': 'Goldberg', 'Affiliation': 'Oncology Center of Excellence, United States Food and Drug Administration.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Theoret', 'Affiliation': 'Center for Drug Evaluation and Research, Food and Drug Administration.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Kluetz', 'Affiliation': 'Oncology Center of Excellence, Food and Drug Administration.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pazdur', 'Affiliation': 'Office of Oncology Drug Products, United States Food and Drug Administration.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Lemery', 'Affiliation': 'Office of Hematology and Oncology Products, Office of New Drugs, Center for Drug Evaluation and Research, United States Food and Drug Administration.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-21-0557'] 3449,33846152,Development of a core outcome set for congenital pulmonary airway malformations: study protocol of an international Delphi survey.,"INTRODUCTION A worldwide lack of consensus exists on the optimal management of asymptomatic congenital pulmonary airway malformation (CPAM) even though the incidence is increasing. Either a surgical resection is performed or a wait-and-see policy is employed, depending on the treating physician. Management is largely based on expert opinion and scientific evidence is scarce. Wide variations in outcome measures are seen between studies making comparison difficult thus highlighting the lack of universal consensus in outcome measures as well. We aim to define a core outcome set which will include the most important core outcome parameters for paediatric patients with an asymptomatic CPAM. METHODS AND ANALYSIS This study will include a critical appraisal of the current literature followed by a three-stage Delphi process with two stakeholder groups. One surgical group including paediatric as well as thoracic surgeons, and a non-surgeon group including paediatric pulmonologists, intensive care and neonatal specialists. All participants will score outcome parameters according to their level of importance and the most important parameters will be determined by consensus. ETHICS AND DISSEMINATION Electronic informed consent will be obtained from all participants. Ethical approval is not required. After the core outcome set has been defined, we intend to design an international randomised controlled trial: the COllaborative Neonatal NEtwork for the first CPAM Trial, which will be aimed at determining the optimal management of patients with asymptomatic CPAM.",2021,"After the core outcome set has been defined, we intend to design an international randomised controlled trial: the COllaborative Neonatal NEtwork for the first CPAM Trial, which will be aimed at determining the optimal management of patients with asymptomatic CPAM.","['patients with asymptomatic CPAM', 'congenital pulmonary airway malformations', 'One surgical group including paediatric as well as thoracic surgeons, and a non-surgeon group including paediatric pulmonologists, intensive care and neonatal specialists', 'paediatric patients with an asymptomatic CPAM']",['surgical resection'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0010668', 'cui_str': 'Congenital cystic adenomatoid malformation of lung'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0278626', 'cui_str': 'Thoracic surgeon'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0586859', 'cui_str': 'Pulmonologist'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}]","[{'cui': 'C0015252', 'cui_str': 'Removal'}]",[],,0.121416,"After the core outcome set has been defined, we intend to design an international randomised controlled trial: the COllaborative Neonatal NEtwork for the first CPAM Trial, which will be aimed at determining the optimal management of patients with asymptomatic CPAM.","[{'ForeName': 'Sergei', 'Initials': 'S', 'LastName': 'Hermelijn', 'Affiliation': ""Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Casper', 'Initials': 'C', 'LastName': 'Kersten', 'Affiliation': ""Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Dhanya', 'Initials': 'D', 'LastName': 'Mullassery', 'Affiliation': 'Pediatric Surgery, Great Ormond Street Hospital for Children, London, UK.'}, {'ForeName': 'Nagarajan', 'Initials': 'N', 'LastName': 'Muthialu', 'Affiliation': 'Pediatric Surgery, Great Ormond Street Hospital for Children, London, UK.'}, {'ForeName': 'Nazan', 'Initials': 'N', 'LastName': 'Cobanoglu', 'Affiliation': 'Pediatric Pulmonology, Ankara University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Gartner', 'Affiliation': ""Pediatric Pulmonology, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Bagolan', 'Affiliation': 'Department of Medical and Surgical Neonatology, Ospedale Pediatrico Bambino Gesu, Roma, Italy.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Mesas Burgos', 'Affiliation': 'Pediatric Surgery, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Sgro', 'Affiliation': 'Pediatric Surgery, Padua University Hospital, Padova, Italy.'}, {'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Heyman', 'Affiliation': ""Pediatric Surgery, ZNA-GZA Paola Children's Hospital, Antwerp, Belgium.""}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Till', 'Affiliation': 'Pediatric Surgery, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Suominen', 'Affiliation': ""Pediatric Surgery, University of Helsinki Children's Hospital, Helsinki, Finland.""}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Schurink', 'Affiliation': ""Pediatric Surgery, Radboud University Medical Centre Amalia Children's Hospital, Nijmegen, The Netherlands.""}, {'ForeName': 'Liesbeth', 'Initials': 'L', 'LastName': 'Desender', 'Affiliation': 'Pediatric Surgery, Ghent University Faculty of Medicine and Health Sciences, Gent, Belgium.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Losty', 'Affiliation': 'Pediatric Surgery, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Kjetil', 'Initials': 'K', 'LastName': 'Ertresvag', 'Affiliation': 'Pediatric Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Harm A W M', 'Initials': 'HAWM', 'LastName': 'Tiddens', 'Affiliation': ""Pediatric Pulmonology, Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Rene M H', 'Initials': 'RMH', 'LastName': 'Wijnen', 'Affiliation': ""Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Schnater', 'Affiliation': ""Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands j.schnater@erasmusmc.nl.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-044544'] 3450,33846151,Compression hosiery to avoid post-thrombotic syndrome (CHAPS) protocol for a randomised controlled trial (ISRCTN73041168).,"INTRODUCTION Up to 50% of patients develop post-thrombotic syndrome (PTS) after an above knee deep vein thrombosis (DVT). The aim of the study was to determine the effect of graduated compression stockings in preventing PTS after DVT. METHODS AND ANALYSIS Pragmatic, UK multicentre randomised trial in adults with first above knee DVT. The standard of care arm is anticoagulation. The intervention arm will receive anticoagulation plus stockings (European class II, 23-32 mm Hg compression) worn for a median of 18 months. The primary endpoint is PTS using the Villalta score. Analysis of this will be through a time to event approach and cumulative incidence at median 6, 12 and 18 months. An ongoing process evaluation will examine factors contributing to adherence to stockings to understand if and how the behavioural interventions were effective. ETHICS AND DISSEMINATION UK research ethics committee approval (reference 19/LO/1585). Dissemination though the charity Thrombosis UK, the Imperial College London website, peer-reviewed publications and international conferences. TRIAL REGISTRATION NUMBER ISRCTN registration number 73041168.",2021,"An ongoing process evaluation will examine factors contributing to adherence to stockings to understand if and how the behavioural interventions were effective. ",['adults with first above knee DVT'],"['graduated compression stockings', 'anticoagulation plus stockings']",['Villalta score'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}]","[{'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038348', 'cui_str': 'Compression stocking'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0445269', 'cui_str': 'Socks'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}]",,0.196196,"An ongoing process evaluation will examine factors contributing to adherence to stockings to understand if and how the behavioural interventions were effective. ","[{'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Thapar', 'Affiliation': 'Academic Section of Vascular Surgery, Imperial College London, London, UK a.thapar09@imperial.ac.uk.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lawton', 'Affiliation': 'Academic Section of Vascular Surgery, Imperial College London, London, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Burgess', 'Affiliation': 'Academic Section of Vascular Surgery, Imperial College London, London, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Shalhoub', 'Affiliation': 'Academic Section of Vascular Surgery, Imperial College London, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bradbury', 'Affiliation': 'Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Nicky', 'Initials': 'N', 'LastName': 'Cullum', 'Affiliation': 'School of Nursing, Midwifery and Social Work, The University of Manchester, Manchester, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Epstein', 'Affiliation': 'Faculty of Economic and Business Sciences, University of Granada, Granada, Andalucía, Spain.'}, {'ForeName': 'Manjit', 'Initials': 'M', 'LastName': 'Gohel', 'Affiliation': ""Department of Vascular Surgery, Addenbrooke's Hospital, Cambridge, Cambridgeshire, UK.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Horne', 'Affiliation': 'School of Pharmacy, University College London, London, London, UK.'}, {'ForeName': 'Beverley J', 'Initials': 'BJ', 'LastName': 'Hunt', 'Affiliation': ""Department of Haematology, Guy's & St Thomas' Foundation Trust, London, UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Davies', 'Affiliation': 'Academic Section of Vascular Surgery, Imperial College London, London, UK.'}]",BMJ open,['10.1136/bmjopen-2020-044285'] 3451,33845980,Approximate arithmetic training does not improve symbolic math in third and fourth grade children.,"BACKGROUND Prior studies reported that practice playing an approximate arithmetic game improved symbolic math performance relative to active control groups in adults and preschool children (e.g. Park & Brannon, 2013, 2014; Park et al., 2016; Szkudlarek & Brannon, 2018). However, Szkudlarek, Park and Brannon (2021) recently failed to replicate those findings in adults. Here we test whether approximate arithmetic training yields benefits in elementary school children who have intermediate knowledge of arithmetic. METHOD We conducted a randomized controlled trial with a pre and post-test design to compare the effects of approximate arithmetic training and visuo-spatial working memory training on standardized math performance in third and fourth grade children. RESULTS We found that approximate arithmetic training did not yield any significant gains on standardized measures of symbolic math performance. CONCLUSION A Bayesian analysis supports the conclusion that approximate arithmetic provides no benefits for symbolic math performance.",2021,"We found that approximate arithmetic training did not yield any significant gains on standardized measures of symbolic math performance. ","['third and fourth grade children', 'elementary school children who have intermediate knowledge of arithmetic', 'adults and preschool children (e.g. Park & Brannon, 2013, 2014; Park et\xa0al., 2016; Szkudlarek & Brannon, 2018']","['approximate arithmetic training', 'approximate arithmetic training and visuo-spatial working memory training', 'Approximate arithmetic training']","['standardized math performance', 'symbolic math performance', 'symbolic math']","[{'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0237771', 'cui_str': 'Parks, Recreational'}]","[{'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]","[{'cui': 'C0024934', 'cui_str': 'Mathematics'}]",,0.0631741,"We found that approximate arithmetic training did not yield any significant gains on standardized measures of symbolic math performance. ","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bugden', 'Affiliation': 'Department of Psychology, University of Pennsylvania, USA. Electronic address: sdbugden@sas.upenn.edu.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Szkudlarek', 'Affiliation': 'Department of Psychology, University of Pennsylvania, USA; Department of Psychology, University of Wisconsin-Madison, USA. Electronic address: szkudlarek@wisc.edu.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Brannon', 'Affiliation': 'Department of Psychology, University of Pennsylvania, USA. Electronic address: ebrannon@psych.upenn.edu.'}]",Trends in neuroscience and education,['10.1016/j.tine.2021.100149'] 3452,33845931,Racial and ethnic differences in response to treatment for Marfan syndrome.,"OBJECTIVE To determine whether racial/ethnic differences exist for the treatment of Marfan syndrome aortopathy. The 2014 Pediatric Heart Network randomised trial of losartan versus atenolol in Marfan syndrome paediatric and young adult patients showed no treatment differences in the rate of aortic root growth over 3 years; however, they did not examine racial/ethnic differences, and recent data suggest that angiotensin receptor blockers may have different pharmacologic effects in different racial/ethnic populations. METHODS We performed a secondary analysis of public-use data from the Pediatric Heart Network randomised trial comparing the differences by race/ethnicity (non-Hispanic White, non-Hispanic Black, and Hispanic patients) amongst the treatment groups for the primary outcome of rate of aortic root enlargement by z score and secondary outcome of rate of change of absolute diameter of aortic root, z score and absolute diameter of ascending aorta, and blood pressure changes. RESULTS For aortic root enlargement by z score amongst on-Hispanic White patients, patients on losartan exhibited an annual z score change of -0.090 ± 0.016, compared to -0.146 ± 0.015 for those on atenolol (p = 0.01), favouring atenolol. For Hispanic and non-Hispanic Black patients, there was no difference in primary or secondary outcomes between treatment groups. CONCLUSION Non-Hispanic White patients had a small, but statistically significantly greater decrease in aortic root z score favouring atenolol over losartan. There were no significant differences amongst Hispanic or non-Hispanic Black patients, which may be due to relatively small size numbers. These findings may have important implications for medication selection by race/ethnicity in Marfan syndrome patients, which has not previously been evaluated in studies.",2021,"Hispanic White patients had a small, but statistically significantly greater decrease in aortic root z score favouring atenolol over losartan.","['Marfan syndrome', 'Marfan syndrome paediatric and young adult patients', 'For Hispanic and non-Hispanic Black patients', 'Marfan syndrome patients']","['atenolol', 'losartan']","['rate of aortic root enlargement by z score and secondary outcome of rate of change of absolute diameter of aortic root, z score and absolute diameter of ascending aorta, and blood pressure changes', 'aortic root z score', 'rate of aortic root growth']","[{'cui': 'C0024796', 'cui_str': ""Marfan's syndrome""}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}]","[{'cui': 'C0004147', 'cui_str': 'Atenolol'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}]","[{'cui': 'C0549113', 'cui_str': 'Supraaortic valve area structure'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0003956', 'cui_str': 'Ascending aorta structure'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]",,0.125173,"Hispanic White patients had a small, but statistically significantly greater decrease in aortic root z score favouring atenolol over losartan.","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Ayers', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kelleman', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Iannucci', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'McCracken', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Oster', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, GA, USA.'}]",Cardiology in the young,['10.1017/S104795112100130X'] 3453,33845929,Efficacy of various prescribed vitamin D supplementation regimens on 25-hydroxyvitamin D serum levels in long-term care.,"OBJECTIVE The aims of this study were to examine the efficacy among various vitamin D supplementation regimens on serum 25(OH)D concentrations and determine the minimal dose rate required to achieve sufficient serum concentrations (≥75 nmol/L) among older adults in long-term care (LTC). DESIGN A one-year medical history was abstracted from medical records, and a one-time blood draw to measure serum 25(OH)D concentrations was obtained. Individuals were stratified into vitamin D supplemented and non-supplemented groups. The supplemented group was further categorized into four treatment forms: single ingredient vitamin D2or3, multivitamin, calcium with vitamin D, or combination of the three, and by daily prescribed doses: 0-399, 400-799, 800-1999, 2000-3999, and >4000 IU/day. SETTING Five LTC communities in Austin, Texas. PARTICIPANTS 173 older (≥65 years) adults. RESULTS Of the participants, 62% received a vitamin D supplement and 55% had insufficient (≤75 nmol/L) 25(OH)D serum concentrations. Individuals receiving single ingredient vitamin D2or3 supplementation received the highest daily vitamin D mean dose (2900 IU/d), while combination of forms was the most frequent treatment (44%) with the highest mean serum concentration (108 nmol/L). All supplementation doses were successful at reaching sufficient serum concentrations, except those <800 IU/d. Using a prediction model, it was observed that one IU/d of vitamin D supplementation resulted in a 0.008 nmol/L increase in serum 25(OH)D concentrations. CONCLUSION Based on the predictive equation, results suggest that supplementation of 1500 IU/d of vitamin D2or3 or combination of vitamin D is most likely to achieve sufficient serum 25(OH)D concentrations in older adults in LTC.",2021,"Using a prediction model, it was observed that one IU/d of vitamin D supplementation resulted in a 0.008 nmol/L increase in serum 25(OH)D concentrations. ","['older adults in LTC', 'Five LTC communities in Austin, Texas', 'older adults in long-term care (LTC', 'long-term care', '173 older (≥65 years) adults']","['single ingredient vitamin D2or3, multivitamin, calcium with vitamin D', 'vitamin D supplement', 'vitamin D supplementation', 'vitamin D2or3 or combination of vitamin D', 'vitamin D supplementation regimens']","['25-hydroxyvitamin D serum levels', 'serum 25(OH)D concentrations']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0605411', 'cui_str': 'austin'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0301532', 'cui_str': 'Multivitamin preparation'}, {'cui': 'C0719107', 'cui_str': 'Calcium and vitamin D product'}, {'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C3653679', 'cui_str': 'Combinations of vitamins'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.19534,"Using a prediction model, it was observed that one IU/d of vitamin D supplementation resulted in a 0.008 nmol/L increase in serum 25(OH)D concentrations. ","[{'ForeName': 'Ronna N', 'Initials': 'RN', 'LastName': 'Robbins', 'Affiliation': 'The University of Texas at Austin, Nutritional Sciences School of Human Ecology, 200 W. 24th Street, GEA 331, Austin, TX78712, United States.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Serra', 'Affiliation': 'Division of Geriatrics, Gerontology & Palliative Medicine and the Sam & Ann Barshop Institute for Longevity & Aging Studies, Department of Medicine, UT Health San Antonio, San Antonio, TX78229, United States.'}, {'ForeName': 'Nalini', 'Initials': 'N', 'LastName': 'Ranjit', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, The University of Texas Health Science Center at Houston (UTHealth) School of Public Health Austin Regional Campus, University of Texas Administration Building,1616 Guadalupe St, Suite 6.300, Austin, TX78701, United States.'}, {'ForeName': 'Deanna M', 'Initials': 'DM', 'LastName': 'Hoelscher', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, The University of Texas Health Science Center at Houston (UTHealth) School of Public Health Austin Regional Campus, University of Texas Administration Building,1616 Guadalupe St, Suite 6.300, Austin, TX78701, United States.'}, {'ForeName': 'Sara J', 'Initials': 'SJ', 'LastName': 'Sweitzer', 'Affiliation': 'The University of Texas at Austin, Nutritional Sciences School of Human Ecology, 200 W. 24th Street, GEA 331, Austin, TX78712, United States.'}, {'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'Briley', 'Affiliation': 'The University of Texas at Austin, Nutritional Sciences School of Human Ecology, 200 W. 24th Street, GEA 331, Austin, TX78712, United States.'}]",Public health nutrition,['10.1017/S1368980021001609'] 3454,33839209,"Catching the audience in a job interview: Effects of emotion regulation strategies on subjective, physiological, and behavioural responses.","In the emotion regulation process more than one strategy is often used, though studies continue to rely on the manipulation of one strategy alone. This study compares the effects of Combined Cognitive Reappraisal (CCR: acceptance and reappraise via perspective-taking) and suppression using the Trier Social Stress Test (TSST). One hundred participants were randomly assigned to one of the two groups and subjective, physiological, and behavioural data were recorded. Continuous electrocardiography was recorded to measure heart rate variability (HRV) and stress levels. Affective ratings were provided before and after the TSST. Behavioural expressions were videotaped and analysed independently. Trait social anxiety/fear, age and gender entered as covariates. Although no group differences were found on affective ratings, the CCR group presented less physiological stress, higher HRV, their speech was better perceived, displayed more affiliative smile and hand gestures. Results suggested that CCR is more appropriate than suppression for managing social stress situations.",2021,"Although no group differences were found on affective ratings, the CCR group presented less physiological stress, higher HRV, their speech was better perceived, displayed more affiliative smile and hand gestures.",['One hundred participants'],"['emotion regulation strategies', 'Combined Cognitive Reappraisal (CCR: acceptance and reappraise via perspective-taking) and suppression using the Trier Social Stress Test (TSST', 'CCR']","['affective ratings', 'heart rate variability (HRV) and stress levels', 'Behavioural expressions', 'subjective, physiological, and behavioural responses', 'Affective ratings', 'physiological stress, higher HRV, their speech was better perceived, displayed more affiliative smile and hand gestures']","[{'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449430', 'cui_str': 'Physiological stress'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205172', 'cui_str': 'More'}, {'cui': 'C0037363', 'cui_str': 'Smiling'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0017510', 'cui_str': 'Gestures'}]",100.0,0.0190236,"Although no group differences were found on affective ratings, the CCR group presented less physiological stress, higher HRV, their speech was better perceived, displayed more affiliative smile and hand gestures.","[{'ForeName': 'Anabela Caetano', 'Initials': 'AC', 'LastName': 'Santos', 'Affiliation': 'Aventura Social and DECSH, Faculdade de Motricidade Humana, Universidade de Lisboa, Lisboa, Portugal; Instituto de Saúde Ambiental (ISAMB), Faculdade de Medicina, Universidade de Lisboa, Lisboa, Portugal; ISCTE - Instituto Universitário de Lisboa (IUL), CIS-IUL, Lisboa, Portugal. Electronic address: anabelasantos@campus.ul.pt.'}, {'ForeName': 'Patrícia', 'Initials': 'P', 'LastName': 'Arriaga', 'Affiliation': 'ISCTE - Instituto Universitário de Lisboa (IUL), CIS-IUL, Lisboa, Portugal.'}, {'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Simões', 'Affiliation': 'Aventura Social and DECSH, Faculdade de Motricidade Humana, Universidade de Lisboa, Lisboa, Portugal; Instituto de Saúde Ambiental (ISAMB), Faculdade de Medicina, Universidade de Lisboa, Lisboa, Portugal.'}]",Biological psychology,['10.1016/j.biopsycho.2021.108089'] 3455,33839197,"Intranasal oxytocin increases state anhedonia following imagery training of positive social outcomes in individuals lower in extraversion, trust-altruism, and openness to experience.","Psychological disorders such as major depressive disorder are characterised by interpersonal difficulties and anhedonia. A cognitive mechanism proposed to contribute to the maintenance of these problems is a diminished ability to generate positive mental imagery, especially regarding social interactions. The current study examined whether the effects of social imagery training on social activity and anhedonia could be enhanced with the addition of intranasal oxytocin, and whether these effects might be augmented in persons with a high propensity to engage socially (i.e., high extraversion). University students (N = 111) were randomised to self-administer intranasal oxytocin or placebo, followed by a single session of positive social or non-social imagery training that required participants to imagine 64 positive scenarios occurring in either a social or non-social context, respectively. There were no main effects of imagery type and drug, and no interaction effect on anhedonia and social activity, measured respectively via self-report and a behavioural task. Individuals low in extraversion, trust-altruism, and openness to experience reported significantly more anhedonia after receiving oxytocin relative to placebo, but only following imagery training of positive social outcomes. Results highlight the negative consequences of increasing oxytocin bioavailability after priming social contact in more withdrawn individuals.",2021,"There were no main effects of imagery type and drug, and no interaction effect on anhedonia and social activity, measured respectively via self-report and a behavioural task.","['persons with a high propensity to engage socially (i.e., high extraversion', 'University students (N\u202f=\u202f111']","['self-administer intranasal oxytocin or placebo, followed by a single session of positive social or non-social imagery training that required participants to imagine 64 positive scenarios occurring in either a social or non-social context, respectively', 'placebo', 'social imagery training', 'Intranasal oxytocin']","['anhedonia and social activity, measured respectively via self-report and a behavioural task', 'state anhedonia', 'social activity and anhedonia', 'anhedonia', 'oxytocin bioavailability']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0015382', 'cui_str': 'Extroversion, Psychological'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517538', 'cui_str': '111'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0037414', 'cui_str': 'Social context'}]","[{'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}]",111.0,0.0229731,"There were no main effects of imagery type and drug, and no interaction effect on anhedonia and social activity, measured respectively via self-report and a behavioural task.","[{'ForeName': 'Shiu F', 'Initials': 'SF', 'LastName': 'Wong', 'Affiliation': 'Department of Psychology, Concordia University, Montreal, Quebec, Canada. Electronic address: shiu.wong@concordia.ca.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Vaillancourt', 'Affiliation': 'Department of Psychology, Concordia University, Montreal, Quebec, Canada.'}, {'ForeName': 'Shawna', 'Initials': 'S', 'LastName': 'Grossman', 'Affiliation': 'Department of Psychology, Concordia University, Montreal, Quebec, Canada.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Kelly-Turner', 'Affiliation': 'Department of Psychology, Concordia University, Montreal, Quebec, Canada.'}, {'ForeName': 'Simon E', 'Initials': 'SE', 'LastName': 'Blackwell', 'Affiliation': 'Faculty of Psychology, Mental Health Research and Treatment Center, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Ellenbogen', 'Affiliation': 'Department of Psychology, Concordia University, Montreal, Quebec, Canada.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2021.03.013'] 3456,33839178,Evaluation of lightwand-guided endotracheal intubation for patients with missing or no teeth: a randomized controlled study.,"BACKGROUND Unhealthy teeth can seriously affect general health and increase the risk of death in elderly people. There has been no confirmation of which device is most effective for elderly patients with teeth loss. Therefore, we compared four intubation devices in elderly patients with partial and total tooth loss, aiming to reduce risk during anesthesia. METHODS Two hundred patients were randomized to undergo tracheal intubation with the Macintosh laryngoscope, the Glidescope, the Fiberoptic bronchoscope or the Lightwand as part of general anesthesia. A unified protocol of anesthetic medications was used. HR and BP were measured at T 0 , T 1 , T 2 , T 3 , T 4 and T 5 . Catecholamine (epinephrine and norepinephrine) blood samples were drawn at T 0 , T 1 and T 2 . Intubation time and postoperative complications, including dental damage and losses, were recorded. RESULTS Reduced fluctuations in HR, DBP and SBP were observed in the Lightwand group. Intubation time was significantly shorter in the Lightwand group (p < 0.05). There was no statistically significant difference between the groups in epinephrine levels, but norepinephrine levels were less volatile in the Fiberoptic bronchoscope and Lightwand groups. Fewer patients in the Lightwand group experienced dental damage and other postoperative complications than in the other three groups. Although a higher success rate on the first attempt was as high as in the Fiberoptic bronchoscope group, shorter intubation time was observed only in the Lightwand group. CONCLUSION The Lightwand offers less hemodynamic stimulation than the Macintosh laryngoscope, Glidescope and Fiberoptic bronchoscope. Because it had the shortest intubation time, the Lightwand caused the least damage to the teeth and throats of elderly patients. Our findings showed that tracheal intubation with the Lightwand was advantageous for preventing cardiovascular stress responses with short intubation times and fewer postoperative complications.",2021,"The Lightwand offers less hemodynamic stimulation than the Macintosh laryngoscope, Glidescope and Fiberoptic bronchoscope.","['Two hundred patients', 'elderly people', 'patients with missing or no teeth', 'elderly patients with teeth loss', 'elderly patients with partial and total tooth loss']","['tracheal intubation with the Macintosh laryngoscope, the Glidescope, the Fiberoptic bronchoscope or the Lightwand', 'lightwand-guided endotracheal intubation', 'Catecholamine (epinephrine and norepinephrine']","['HR, DBP and SBP', 'dental damage and other postoperative complications', 'HR and BP', 'success rate', 'hemodynamic stimulation', 'postoperative complications', 'epinephrine levels, but norepinephrine levels', 'shorter intubation time', 'Intubation time', 'cardiovascular stress responses', 'Intubation time and postoperative complications, including dental damage and losses']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0080233', 'cui_str': 'Tooth loss'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0179433', 'cui_str': 'Flexible bronchoscope'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0007412', 'cui_str': 'Catecholamine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}]","[{'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0201998', 'cui_str': 'Epinephrine measurement'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",200.0,0.0246862,"The Lightwand offers less hemodynamic stimulation than the Macintosh laryngoscope, Glidescope and Fiberoptic bronchoscope.","[{'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Ge', 'Affiliation': ""Anhui Medical University, The First Affiliated Hospital, Department of Anesthesiology, Hefei, China; Bozhou People's Hospital, Department of Anesthesiology, Bozhou, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': ""Bozhou People's Hospital, Department of Anesthesiology, Bozhou, China.""}, {'ForeName': 'Ziting', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ""Bozhou People's Hospital, Department of Anesthesiology, Bozhou, China.""}, {'ForeName': 'Fenglei', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': ""Bozhou People's Hospital, Department of Anesthesiology, Bozhou, China.""}, {'ForeName': 'Tengfei', 'Initials': 'T', 'LastName': 'Zhao', 'Affiliation': ""Bozhou People's Hospital, Department of Anesthesiology, Bozhou, China.""}, {'ForeName': 'Yuanhai', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Anhui Medical University, The First Affiliated Hospital, Department of Anesthesiology, Hefei, China. Electronic address: liyuanhai-1@163.com.'}]",Brazilian journal of anesthesiology (Elsevier),['10.1016/j.bjane.2021.03.002'] 3457,33839130,Development and Validation of a Risk Score for Respiratory Failure After Cardiac Surgery.,"BACKGROUND Postoperative respiratory failure, defined as ventilator dependency for more than 48 hours or unplanned reintubation within 30 days, is a costly complication of cardiac surgery that increases mortality and length of stay. Stratification of patients by risk upon intensive care unit admission could identify cases requiring early measures to prevent respiratory failure. This study aimed to develop and validate a risk score for postoperative respiratory failure after cardiac surgery. METHODS This retrospective analysis of 4262 patients admitted to the cardiovascular intensive care unit after major cardiac surgery between 01/2013 and 12/2017, used the Society of Thoracic Surgeons database and ventilator data from the respiratory therapy department. Patients were randomly and equally assigned to development and validation cohorts. Covariates used in the multivariable models were assigned weighted points proportional to their β regression coefficient values to create the risk score, which categorized patients into low, medium, and high risk of postoperative respiratory failure. RESULTS In both cohorts, postoperative respiratory failure risk was significantly different between risk categories. Compared to low-risk patients, moderate-risk patients had a two times greater risk, and high-risk patients had a four to seven times greater risk. Body mass index, previous cardiac surgery, cardiopulmonary bypass, cardiogenic shock, pulmonary disease presence, baseline functional status, hemodynamic instability, and number of blood products used intraoperatively were significant predictors of respiratory failure. CONCLUSIONS This risk score can stratify patients by risk for developing postoperative respiratory failure after major cardiac surgery, which may help in the development of preventive measures.",2021,"In both cohorts, postoperative respiratory failure risk was significantly different between risk categories.","['4262 patients admitted to the cardiovascular intensive care unit after major cardiac surgery between 01/2013 and 12/2017, used the Society of Thoracic Surgeons database and ventilator data from the respiratory therapy department']",[],"['Body mass index, previous cardiac surgery, cardiopulmonary bypass, cardiogenic shock, pulmonary disease presence, baseline functional status, hemodynamic instability, and number of blood products', 'mortality and length of stay', 'postoperative respiratory failure risk', 'Development and Validation of a Risk Score for Respiratory Failure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0278626', 'cui_str': 'Thoracic surgeon'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0035239', 'cui_str': 'Respiratory therapy'}]",[],"[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0948268', 'cui_str': 'Hemodynamic instability'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0456388', 'cui_str': 'Blood product'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C3495821', 'cui_str': 'Postoperative respiratory failure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}]",4262.0,0.176003,"In both cohorts, postoperative respiratory failure risk was significantly different between risk categories.","[{'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Zainab', 'Affiliation': 'Houston Methodist DeBakey Heart & Vascular Center, Houston Methodist Hospital; Center for Critical Care, Houston Methodist Hospital. Electronic address: azainab@houstonmethodist.org.'}, {'ForeName': 'Duc T', 'Initials': 'DT', 'LastName': 'Nguyen', 'Affiliation': 'Department of Pathology and Genomic Medicine, Houston Methodist Research Institute.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Graviss', 'Affiliation': 'Department of Pathology and Genomic Medicine, Houston Methodist Research Institute; Department of Surgery, Houston Methodist Hospital.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Fatima', 'Affiliation': 'Department of Anesthesia and Critical Care, Houston Methodist Hospital.'}, {'ForeName': 'Faisal N', 'Initials': 'FN', 'LastName': 'Masud', 'Affiliation': 'Houston Methodist DeBakey Heart & Vascular Center, Houston Methodist Hospital; Center for Critical Care, Houston Methodist Hospital.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'MacGillivray', 'Affiliation': 'Houston Methodist DeBakey Heart & Vascular Center, Houston Methodist Hospital; Department of Cardiovascular Surgery, Houston Methodist Hospital.'}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2021.03.082'] 3458,33839106,"Letter to editor on ""Proximal vs Distal Approach of Ultrasound-guided Suprascapular Nerve Block for Patients With Adhesive Capsulitis of the Shoulder: Prospective Randomized Controlled Trial"".",,2021,,['Patients With Adhesive Capsulitis of the Shoulder'],"['Letter to editor on ""Proximal vs Distal Approach of Ultrasound-guided Suprascapular Nerve Block']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0311223', 'cui_str': 'Adhesive capsulitis of shoulder'}]","[{'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0394703', 'cui_str': 'Injection of anesthetic agent into suprascapular nerve'}]",[],,0.0457965,,"[{'ForeName': 'Ke-Vin', 'Initials': 'KV', 'LastName': 'Chang', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Bei-Hu Branch, Taipei, Taiwan; National Taiwan University College of Medicine, Taipei, Taiwan. Electronic address: kvchang011@gmail.com.'}, {'ForeName': 'Wei-Ting', 'Initials': 'WT', 'LastName': 'Wu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Bei-Hu Branch, Taipei, Taiwan; National Taiwan University College of Medicine, Taipei, Taiwan.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.12.034'] 3459,33839105,Robotic locomotor training leads to cardiovascular changes in individuals with incomplete spinal cord injury over a 24-week rehabilitation period: a randomized controlled pilot study.,"OBJECTIVE To describe the effect of robotic locomotor training (RLT) and activity-based training (ABT) on cardiovascular indices during various physiological perturbations in individuals with SCI. DESIGN Randomized controlled pilot study SETTING: Private practice: Therapy & Beyond Centre - Walking with Brandon Foundation, Sports Science Institute of South Africa, Cape Town, South Africa. PARTICIPANTS 16 participants with chronic traumatic motor incomplete tetraplegia who resided in the Western Cape, South Africa INTERVENTIONS: Robotic locomotor training (Ekso GT) and activity-based training over a 24-week intervention. MAIN OUTCOME MEASURES Brachial and ankle blood pressure, heart rate, heart rate variability, cardiovascular efficiency during four physiological perturbations. RESULTS No differences between groups or over time were evident in resting systolic and diastolic blood pressure, ankle systolic pressure, ankle brachial pressure index and heart rate variability. Standing heart rate at 24-weeks was significantly higher in the ABT group (95.58 ± 12.61 beats/min) compared to the RLT group (75.14 ± 14.96 beats/min) (p = 0.05). In the RLT group, no significant changes in heart rate variability (standard deviation R-R interval and root mean square of successive differences) was found between the standing and 6-minute walk test physiological perturbations throughout the intervention. Cardiovascular efficiency in the RLT group during the 6-minute walk test improved from 11.1 ± 2.6 at baseline to 7.5 ± 2.8 beats per metre walked at 6-weeks, and was maintained from 6 to 24-weeks. CONCLUSIONS Large effect sizes and significant differences between groups found in this pilot study support the clinical effectiveness of RLT and ABT for changing cardiovascular indices as early as 6-weeks and up to 24-weeks of rehabilitation. RLT may be more effective than ABT in improving cardiac responses to orthostatic stress. Based on heart rate variability metrics, the stimulus of standing has comparable effects to RLT on the parasympathetic nervous system. Cardiovascular efficiency of exoskeleton walking improved, particularly over the first 6-weeks. Both the RLT and ABT interventions were limited in their effect on brachial and ankle blood pressure. A RCT with a larger sample size is warranted to further examine these findings.",2021,"No differences between groups or over time were evident in resting systolic and diastolic blood pressure, ankle systolic pressure, ankle brachial pressure index and heart rate variability.","['South Africa, Cape Town, South Africa', 'individuals with incomplete spinal cord injury over a 24-week rehabilitation period', '16 participants with chronic traumatic motor incomplete tetraplegia who resided in the Western Cape, South Africa', 'individuals with SCI']","['RLT and ABT', 'ABT', 'Robotic locomotor training', 'RLT', 'Robotic locomotor training (Ekso GT) and activity-based training', 'robotic locomotor training (RLT) and activity-based training (ABT']","['heart rate variability', 'Cardiovascular efficiency', 'Standing heart rate', 'resting systolic and diastolic blood pressure, ankle systolic pressure, ankle brachial pressure index and heart rate variability', 'Brachial and ankle blood pressure, heart rate, heart rate variability, cardiovascular efficiency during four physiological perturbations', 'cardiovascular changes', 'Cardiovascular efficiency of exoskeleton walking', 'brachial and ankle blood pressure']","[{'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0034372', 'cui_str': 'Tetraplegia'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0419113', 'cui_str': 'Locomotor training'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1276055', 'cui_str': 'Ankle brachial pressure index'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",16.0,0.0470553,"No differences between groups or over time were evident in resting systolic and diastolic blood pressure, ankle systolic pressure, ankle brachial pressure index and heart rate variability.","[{'ForeName': 'R W', 'Initials': 'RW', 'LastName': 'Evans', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Shackleton', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'West', 'Affiliation': 'Department of Sport Management, Cape Peninsula University of Technology, Cape Town, South Africa.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Derman', 'Affiliation': 'Institute of Sport and Exercise Medicine, Division of Orthopaedic Surgery, Faculty of Medicine and Health Sciences, University of Stellenbosch, Cape Town, South Africa; IOC Research Centre, South Africa.'}, {'ForeName': 'Hg L', 'Initials': 'HL', 'LastName': 'Rauch', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Baalbergen', 'Affiliation': 'Rehabilitation Unit, Life Vincent Pallotti Hospital, Cape Town, South Africa.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Albertus', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa. Electronic address: yumna.albertus@uct.ac.za.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2021.03.018'] 3460,33839076,Levosimendan Improves Hemodynamics and Exercise Tolerance in PH-HFpEF: Results of the Randomized Placebo-Controlled HELP Trial.,"OBJECTIVES The purpose of this study was to evaluate the effects of intravenous levosimendan on hemodynamics and 6-min walk distance (6MWD) in patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). BACKGROUND There are no proven effective treatments for patients with PH-HFpEF. METHODS Patients with mean pulmonary artery pressure (mPAP) ≥35 mm Hg, pulmonary capillary wedge pressure (PCWP) ≥20 mm Hg, and LVEF ≥40% underwent 6MWD and hemodynamic measurements at rest, during passive leg raise, and supine cycle exercise at baseline and after an open-label 24-h levosimendan infusion (0.1 μg/kg/min). Hemodynamic responders (those with ≥4 mm Hg reduction of exercise-PCWP) were randomized (double blind) to weekly levosimendan infusion (0.075 to 0.1ug/kg/min for 24 h) or placebo for 5 additional weeks. The primary end point was exercise-PCWP, and key secondary end points included 6MWD and PCWP measured across all exercise stages. RESULTS Thirty-seven of 44 patients (84%) met responder criteria and were randomized to levosimendan (n = 18) or placebo (n = 19). Participants were 69 ± 9 years of age, 61% female, and with resting mPAP 41.0 ± 9.3 mm Hg and exercise-PCWP 36.8 ± 11.3 mm Hg. Compared with placebo, levosimendan did not significantly reduce the primary end point of exercise-PCWP at 6 weeks (-1.4 mm Hg; 95% confidence interval [CI]: -7.8 to 4.8; p = 0.65). However, levosimendan reduced PCWP measured across all exercise stages (-3.9 ± 2.0 mm Hg; p = 0.047). Levosimendan treatment resulted in a 29.3 m (95% CI: 2.5 to 56.1; p = 0.033) improvement in 6MWD compared with placebo. CONCLUSIONS Six weeks of once-weekly levosimendan infusion did not affect exercise-PCWP but did reduce PCWP incorporating data from rest and exercise, in tandem with increased 6MWD. Further study of levosimendan is warranted as a therapeutic option for PH-HFpEF. (Hemodynamic Evaluation of Levosimendan in Patients With PH-HFpEF [HELP]; NCT03541603).",2021,"Six weeks of once-weekly levosimendan infusion did not affect exercise-PCWP but did reduce PCWP incorporating data from rest and exercise, in tandem with increased 6MWD.","['Participants were 69 ± 9 years of age, 61% female, and with resting mPAP 41.0 ± 9.3\xa0mm', 'Patients With PH-HFpEF [HELP', 'Patients with mean pulmonary artery pressure (mPAP)\xa0≥35\xa0mm', 'PH-HFpEF', 'Thirty-seven of 44 patients (84%) met responder criteria', 'patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF', '≥40']","['levosimendan', 'levosimendan infusion', 'placebo, levosimendan', 'Levosimendan', 'exercise-PCWP', 'placebo', 'Placebo']","['exercise-PCWP, and key secondary end points included 6MWD and PCWP measured across all exercise stages', 'exercise-PCWP', 'PCWP', 'Hg, pulmonary capillary wedge pressure (PCWP)\xa0≥20\xa0mm\xa0Hg, and LVEF', 'Hemodynamics and Exercise Tolerance', '6MWD', 'hemodynamics and 6-min walk distance (6MWD']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0246904', 'cui_str': 'Levosimendan'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034094', 'cui_str': 'Pulmonary artery wedge pressure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034094', 'cui_str': 'Pulmonary artery wedge pressure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}]",,0.265507,"Six weeks of once-weekly levosimendan infusion did not affect exercise-PCWP but did reduce PCWP incorporating data from rest and exercise, in tandem with increased 6MWD.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Burkhoff', 'Affiliation': 'Cardiovascular Research Foundation, New York, New York, USA. Electronic address: dburkhoff@crf.org.'}, {'ForeName': 'Barry A', 'Initials': 'BA', 'LastName': 'Borlaug', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Sanjiv J', 'Initials': 'SJ', 'LastName': 'Shah', 'Affiliation': 'Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Zolty', 'Affiliation': 'University of Nebraska Medical Center, Omaha, Nebraska, USA.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Tedford', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Thenappan', 'Initials': 'T', 'LastName': 'Thenappan', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Roham T', 'Initials': 'RT', 'LastName': 'Zamanian', 'Affiliation': 'Stanford University, Stanford, California, USA.'}, {'ForeName': 'Jeremy A', 'Initials': 'JA', 'LastName': 'Mazurek', 'Affiliation': 'Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Rich', 'Affiliation': 'Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Simon', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvani, USA.'}, {'ForeName': 'Eugene S', 'Initials': 'ES', 'LastName': 'Chung', 'Affiliation': 'Lindner Research Center at The Christ Hospital, Cincinnati, Ohio, USA.'}, {'ForeName': 'Farhan', 'Initials': 'F', 'LastName': 'Raza', 'Affiliation': 'University of Wisconsin, Madison, Wisconsin, USA.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Majure', 'Affiliation': 'North Shore University Hospital, Manhasset, New York, USA.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Lewis', 'Affiliation': 'Massachusetts, General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Ioana R', 'Initials': 'IR', 'LastName': 'Preston', 'Affiliation': 'Tufts Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Rich', 'Affiliation': 'Northwestern University, Chicago, Illinois, USA.'}]",JACC. Heart failure,['10.1016/j.jchf.2021.01.015'] 3461,33839075,Worsening Heart Failure Episodes Outside a Hospital Setting in Heart Failure with Preserved Ejection Fraction: The PARAGON-HF Trial.,"OBJECTIVES To evaluate the frequency and prognostic implications of urgent heart failure (HF) visits in a large global clinical trial of HF with preserved ejection fraction (HFpEF). BACKGROUND Episodes of worsening HF managed without hospitalization are common and prognostically important in HF with reduced ejection fraction (EF). The significance of these ambulatory worsening HF events in HFpEF is uncertain. METHODS PARAGON-HF (Prospective Comparison of ARNI with ARB Global Outcomes in HF with Preserved Ejection Fraction) randomly assigned 4,796 patients with HFpEF (≥45%) to treatment with sacubitril/valsartan vs. valsartan with a primary composite endpoint of total HF hospitalizations and cardiovascular death. Urgent ambulatory HF visits requiring intravenous diuretic treatment were prospectively collected and adjudicated by a blinded committee. We examined the effect of study treatment on a prespecified expanded composite of cardiovascular death and worsening HF events (including HF hospitalizations and urgent HF visits) and the effect of each type of HF event on subsequent mortality. RESULTS Of 884 first worsening HF events, 66 (7.5%) were urgent HF visits. Patients whose first episode of worsening HF event was an urgent visit had similar age, comorbidities, baseline N-terminal prohormone of B-type natriuretic peptide, and Meta-Analysis Global Group in Chronic Heart Failure risk scores to those in whom the first HF event was a hospitalization (all comparisons p > 0.05). Regardless of the treatment setting, patients with a first episode of worsening HF had higher rates of subsequent death (19.2 per 100 patient-years; 95% confidence interval [CI]: 16.9 to 21.8 for HF hospitalization and 10.1 per 100 patients-years; 95% CI: 5.4 to 18.7 for urgent HF visit) compared with those who did not experience worsening HF (death rate 4.0 per 100 patient-years; 95% CI: 3.6 to 4.4). Including total urgent HF visits in the composite study endpoint added 95 total events and would have shortened the trial duration needed for event accrual. The addition of urgent HF visits in a prespecified composite endpoint reinforced the treatment efficacy of sacubitril/valsartan compared with valsartan (rate ratio 0.86; 95% CI: 0.75 to 0.99; p = 0.040). CONCLUSIONS Like HF hospitalizations, worsening HF events treated in the ambulatory setting are prognostically important in HFpEF. Inclusion of these events in the composite primary endpoint underscores the benefit of sacubitril/valsartan compared with valsartan in PARAGON-HF. (Prospective Comparison of ARNI with ARB Global Outcomes in HF with Preserved Ejection Fraction [PARAGON-HF]; NCT01920711).",2021,"Patients whose first episode of worsening HF event was an urgent visit had similar age, comorbidities, baseline N-terminal prohormone of B-type natriuretic peptide, and Meta-Analysis Global Group in Chronic Heart ","['urgent heart failure', 'Urgent ambulatory HF visits requiring intravenous diuretic treatment', 'Patients whose first episode of worsening HF event was an urgent visit had similar age, comorbidities, baseline N-terminal prohormone of B-type natriuretic peptide, and Meta-Analysis Global Group in Chronic Heart', 'Failure with Preserved Ejection Fraction', 'HF with Preserved Ejection Fraction) randomly assigned 4,796 patients with HFpEF (≥45%) to treatment with', 'Worsening Heart\xa0Failure Episodes Outside a Hospital Setting in Heart']","['sacubitril/valsartan vs. valsartan', 'sacubitril/valsartan', 'valsartan']","['total HF hospitalizations and cardiovascular death', 'trial duration needed for event accrual', 'cardiovascular death and worsening HF events', 'Failure risk scores', 'urgent HF visits', 'total urgent HF visits', 'benefit of sacubitril/valsartan', 'rates of subsequent death', 'hospitalization']","[{'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0948575', 'cui_str': 'Diuretic therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0301817', 'cui_str': 'Prohormone'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0282458', 'cui_str': 'Meta-Analysis'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0332282', 'cui_str': 'Following'}]",4796.0,0.256052,"Patients whose first episode of worsening HF event was an urgent visit had similar age, comorbidities, baseline N-terminal prohormone of B-type natriuretic peptide, and Meta-Analysis Global Group in Chronic Heart ","[{'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Cunningham', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Finnian Mc', 'Initials': 'FM', 'LastName': 'Causland', 'Affiliation': ""Division of Nephrology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Barkoudah', 'Affiliation': ""Hospital Medicine Unit and Division of General Internal Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Finn', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Université de Lorraine INSERM, Centre, d'Investigations Cliniques Plurithématique 1433, INSERM U1116, CHRU de Nancy, F-CRIN INI-CRCT, Nancy, France.""}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Pfeffer', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Adel R', 'Initials': 'AR', 'LastName': 'Rizkala', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, New Jersey, USA.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Sabarwal', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, New Jersey, USA.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Akshay S', 'Initials': 'AS', 'LastName': 'Desai', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA. Electronic address: adesai@bwh.harvard.edu.""}]",JACC. Heart failure,['10.1016/j.jchf.2021.01.014'] 3462,33839061,"The combination of traditional and auricular acupuncture to prevent xerostomia and anxiety in irradiated patients with HNSCC: a preventive, parallel, single-blind, 2-arm controlled study.","OBJECTIVE The purpose of the present study was to investigate the effect of acupuncture on xerostomia in irradiated patients with head and neck squamous cell carcinoma (HNSCC). STUDY DESIGN A preventive, 2-arm, parallel, single-blind trial was performed. Patients with HNSCC (N = 296) were checked for eligibility, and 107 patients were enrolled in the study. The study comprised 1 group that did not receive the intervention (n = 55) and the interventional group that received traditional and auricular acupuncture (n = 52). The primary outcome was the reduction of the patients' xerostomia after treatment. In addition, the secondary outcome was the reduction of anxiety. RESULTS The current acupuncture protocol reduced the xerostomia score and increased saliva volume and density without changing salivary pH. Additionally, acupuncture decreased the Beck Anxiety Inventory (BAI) score after radiation therapy. CONCLUSION Combining traditional and auricular acupuncture reduced xerostomia and increased saliva volume without changing the saliva's pH in irradiated patients with HNSCC. Additionally, the combination of traditional and auricular acupuncture reduced BAI scores.",2021,Combining traditional and auricular acupuncture reduced xerostomia and increased saliva volume without changing the saliva's pH in irradiated patients with HNSCC.,"['Patients with HNSCC', 'N\xa0=\xa0296) were checked for eligibility, and 107 patients were enrolled in the study', 'irradiated patients with HNSCC', 'irradiated patients with head and neck squamous cell carcinoma (HNSCC']","['acupuncture', 'traditional and auricular acupuncture', 'interventional group that received traditional and auricular acupuncture']","['xerostomia', 'xerostomia score and increased saliva volume and density', 'xerostomia and increased saliva volume', 'xerostomia and anxiety', 'Beck Anxiety Inventory (BAI) score', 'reduction of anxiety', 'BAI scores', ""reduction of the patients' xerostomia""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1277077', 'cui_str': 'Irradiated blood product'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0752217', 'cui_str': 'Ear Acupuncture'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C4274492', 'cui_str': 'Beck Anxiety Inventory score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",296.0,0.0893886,Combining traditional and auricular acupuncture reduced xerostomia and increased saliva volume without changing the saliva's pH in irradiated patients with HNSCC.,"[{'ForeName': 'Agna Soares da Silva', 'Initials': 'ASDS', 'LastName': 'Menezes', 'Affiliation': 'Department of Dentistry, Universidade Estadual de Montes Claros, Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'Gabriela Luize Guimarães', 'Initials': 'GLG', 'LastName': 'Sanches', 'Affiliation': 'Department of Dentistry, Universidade Estadual de Montes Claros, Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'Emisael Stênio Batista', 'Initials': 'ESB', 'LastName': 'Gomes', 'Affiliation': 'Department of Dentistry, Universidade Estadual de Montes Claros, Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'Raquel Gusmão', 'Initials': 'RG', 'LastName': 'Soares', 'Affiliation': 'Department of Dentistry, Universidade Estadual de Montes Claros, Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'Cristina Paixão', 'Initials': 'CP', 'LastName': 'Durães', 'Affiliation': 'Department of Dentistry, Universidade Estadual de Montes Claros, Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'Larissa Lopes', 'Initials': 'LL', 'LastName': 'Fonseca', 'Affiliation': 'Department of Dentistry, Universidade Estadual de Montes Claros, Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'Arlen de Paulo Santiago', 'Initials': 'APS', 'LastName': 'Filho', 'Affiliation': 'Dilson Godinho Hospital, Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'Adriana Aparecida Almeida de Aguiar', 'Initials': 'AAAA', 'LastName': 'Ribeiro', 'Affiliation': 'Dilson Godinho Hospital, Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'Jairo Evangelista', 'Initials': 'JE', 'LastName': 'Nascimento', 'Affiliation': 'Department of Dentistry, Universidade Estadual de Montes Claros, Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'Sérgio Henrique Sousa', 'Initials': 'SHS', 'LastName': 'Santos', 'Affiliation': 'Institute of Agricultural Sciences, Universidade Federal de Minas Gerais, Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'Alfredo Maurício Batista', 'Initials': 'AMB', 'LastName': 'de Paula', 'Affiliation': 'Department of Dentistry, Universidade Estadual de Montes Claros, Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'Lucyana Conceição', 'Initials': 'LC', 'LastName': 'Farias', 'Affiliation': 'Department of Dentistry, Universidade Estadual de Montes Claros, Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'André Luiz Sena', 'Initials': 'ALS', 'LastName': 'Guimarães', 'Affiliation': 'Department of Dentistry, Universidade Estadual de Montes Claros, Montes Claros, Minas Gerais, Brazil; Dilson Godinho Hospital, Montes Claros, Minas Gerais, Brazil. Electronic address: andreluizguimaraes@gmail.com.'}]","Oral surgery, oral medicine, oral pathology and oral radiology",['10.1016/j.oooo.2021.02.016'] 3463,33838763,Self-Efficacy for Healthy Eating Moderates the Impact of Stress on Diet Quality Among Family Child Care Home Providers.,"OBJECTIVE To examine associations of stress and sleep with diet quality of family child care home (FCCH) providers, and whether self-efficacy for healthy eating influences these associations. DESIGN A cross-sectional analysis was performed using baseline data (2013-2015) from a randomized control trial with FCCH providers. PARTICIPANTS The study included 166 licensed FCCH providers, aged >18 years, from central North Carolina. MAIN OUTCOME MEASURE(S) Diet quality was assessed with a food frequency questionnaire, used to calculate a modified 2010-Healthy Eating Index score. Stress, sleep quality, and diet self-efficacy were measured via self-administered questionnaires. ANALYSIS Using observations from 158 participants with complete data, multiple linear regression models were created to assess whether stress, sleep quality, and diet self-efficacy were associated with diet quality and whether diet self-efficacy moderated these associations (significance set at P < 0.05). RESULTS In the initial model, only diet self-efficacy was significantly associated with diet quality (β = 0.32; P < 0.001). Moderation analyses showed that higher stress was associated with lower diet quality, but only when diet self-efficacy was low. CONCLUSIONS Building FCCH providers' self-efficacy for healthy eating is an important component of health promotion and can buffer the impact of stress on their diet quality.",2021,"Moderation analyses showed that higher stress was associated with lower diet quality, but only when diet self-efficacy was low. ","['The study included 166 licensed FCCH providers, aged >18 years, from central North Carolina', '158 participants with complete data', 'Healthy Eating Moderates', 'family child care home (FCCH) providers', 'healthy eating']",[],"['diet quality', 'lower diet quality', 'Diet quality', 'Stress, sleep quality, and diet self-efficacy', 'stress, sleep quality, and diet self-efficacy', 'Diet Quality']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008067', 'cui_str': 'Puericulture'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]",[],"[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",166.0,0.026944,"Moderation analyses showed that higher stress was associated with lower diet quality, but only when diet self-efficacy was low. ","[{'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Dobson', 'Affiliation': 'Department of Nutrition, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Regan', 'Initials': 'R', 'LastName': 'Burney', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Hales', 'Affiliation': 'Department of Nutrition, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC; Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Vaughn', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Tovar', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Rhode Island, Kingston, RI.'}, {'ForeName': 'Truls', 'Initials': 'T', 'LastName': 'Østbye', 'Affiliation': 'Department of Family Medicine and Community Health, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'Ward', 'Affiliation': 'Department of Nutrition, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC; Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, NC. Electronic address: dsward@email.unc.edu.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2021.01.005'] 3464,33838758,"The SANAD II study of the effectiveness and cost-effectiveness of valproate versus levetiracetam for newly diagnosed generalised and unclassifiable epilepsy: an open-label, non-inferiority, multicentre, phase 4, randomised controlled trial.","BACKGROUND Valproate is a first-line treatment for patients with newly diagnosed idiopathic generalised or difficult to classify epilepsy, but not for women of child-bearing potential because of teratogenicity. Levetiracetam is increasingly prescribed for these patient populations despite scarcity of evidence of clinical effectiveness or cost-effectiveness. We aimed to compare the long-term clinical effectiveness and cost-effectiveness of levetiracetam compared with valproate in participants with newly diagnosed generalised or unclassifiable epilepsy. METHODS We did an open-label, randomised controlled trial to compare levetiracetam with valproate as first-line treatment for patients with generalised or unclassified epilepsy. Adult and paediatric neurology services (69 centres overall) across the UK recruited participants aged 5 years or older (with no upper age limit) with two or more unprovoked generalised or unclassifiable seizures. Participants were randomly allocated (1:1) to receive either levetiracetam or valproate, using a minimisation programme with a random element utilising factors. Participants and investigators were aware of treatment allocation. For participants aged 12 years or older, the initial advised maintenance doses were 500 mg twice per day for levetiracetam and valproate, and for children aged 5-12 years, the initial daily maintenance doses advised were 25 mg/kg for valproate and 40 mg/kg for levetiracetam. All drugs were administered orally. SANAD II was designed to assess the non-inferiority of levetiracetam compared with valproate for the primary outcome time to 12-month remission. The non-inferiority limit was a hazard ratio (HR) of 1·314, which equates to an absolute difference of 10%. A HR greater than 1 indicated that an event was more likely on valproate. All participants were included in the intention-to-treat (ITT) analysis. Per-protocol (PP) analyses excluded participants with major protocol deviations and those who were subsequently diagnosed as not having epilepsy. Safety analyses included all participants who received one dose of any study drug. This trial is registered with the ISRCTN registry, 30294119 (EudraCt number: 2012-001884-64). FINDINGS 520 participants were recruited between April 30, 2013, and Aug 2, 2016, and followed up for a further 2 years. 260 participants were randomly allocated to receive levetiracetam and 260 participants to receive valproate. The ITT analysis included all participants and the PP analysis included 255 participants randomly allocated to valproate and 254 randomly allocated to levetiracetam. Median age of participants was 13·9 years (range 5·0-94·4), 65% were male and 35% were female, 397 participants had generalised epilepsy, and 123 unclassified epilepsy. Levetiracetam did not meet the criteria for non-inferiority in the ITT analysis of time to 12-month remission (HR 1·19 [95% CI 0·96-1·47]); non-inferiority margin 1·314. The PP analysis showed that the 12-month remission was superior with valproate than with levetiracetam. There were two deaths, one in each group, that were unrelated to trial treatments. Adverse reactions were reported by 96 (37%) participants randomly assigned to valproate and 107 (42%) participants randomly assigned to levetiracetam. Levetiracetam was dominated by valproate in the cost-utility analysis, with a negative incremental net health benefit of -0·040 (95% central range -0·175 to 0·037) and a probability of 0·17 of being cost-effectiveness at a threshold of £20 000 per quality-adjusted life-year. Cost-effectiveness was based on differences between treatment groups in costs and quality-adjusted life-years. INTERPRETATION Compared with valproate, levetiracetam was found to be neither clinically effective nor cost-effective. For girls and women of child-bearing potential, these results inform discussions about benefit and harm of avoiding valproate. FUNDING National Institute for Health Research Health Technology Assessment Programme.",2021,Levetiracetam did not meet the criteria for non-inferiority in the ITT analysis of time to 12-month remission (HR 1·19 [95% CI 0·96-1·47]); non-inferiority margin 1·314.,"['520 participants were recruited between April 30, 2013, and Aug 2, 2016, and followed up for a further 2 years', 'and 260 participants to receive', 'patients with newly diagnosed idiopathic generalised or difficult to classify epilepsy', 'participants with newly diagnosed generalised or unclassifiable epilepsy', 'patients with generalised or unclassified epilepsy', 'participants who received one dose of any study drug', 'participants aged 12 years or older', 'Adult and paediatric neurology services (69 centres overall) across the UK recruited participants aged 5 years or older (with no upper age limit) with two or more unprovoked generalised or unclassifiable seizures', 'newly diagnosed generalised and unclassifiable epilepsy', 'All participants were included in the intention-to-treat (ITT) analysis', 'Median age of participants was 13·9 years (range 5·0-94·4), 65% were male and 35% were female, 397 participants had generalised epilepsy, and 123 unclassified epilepsy', 'participants with major protocol deviations and those who were subsequently diagnosed as not having epilepsy', '260 participants']","['levetiracetam with valproate', 'valproate', 'valproate versus levetiracetam', 'Valproate', 'levetiracetam or valproate', 'valproate and 40 mg/kg for levetiracetam', 'Levetiracetam', 'levetiracetam and valproate', 'levetiracetam', 'valproate, levetiracetam']","['Adverse reactions', 'Cost-effectiveness', 'clinically effective nor cost-effective']","[{'cui': 'C4517803', 'cui_str': '520'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0205426', 'cui_str': 'Unclassified'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0587601', 'cui_str': 'Pediatric neurology service'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}]","[{'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",520.0,0.596679,Levetiracetam did not meet the criteria for non-inferiority in the ITT analysis of time to 12-month remission (HR 1·19 [95% CI 0·96-1·47]); non-inferiority margin 1·314.,"[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Marson', 'Affiliation': 'Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK. Electronic address: a.g.marson@liverpool.ac.uk.'}, {'ForeName': 'Girvan', 'Initials': 'G', 'LastName': 'Burnside', 'Affiliation': 'Department of Health Data Science, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Appleton', 'Affiliation': ""The Roald Dahl EEG Unit, Alder Hey Children's Health Park, Liverpool, UK.""}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': 'The Walton Centre NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'John Paul', 'Initials': 'JP', 'LastName': 'Leach', 'Affiliation': 'School of Medicine, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Sills', 'Affiliation': 'Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Catrin', 'Initials': 'C', 'LastName': 'Tudur-Smith', 'Affiliation': 'Department of Health Data Science, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Catrin', 'Initials': 'C', 'LastName': 'Plumpton', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, Wales, UK.'}, {'ForeName': 'Dyfrig A', 'Initials': 'DA', 'LastName': 'Hughes', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, Wales, UK.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Williamson', 'Affiliation': 'Department of Health Data Science, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Gus A', 'Initials': 'GA', 'LastName': 'Baker', 'Affiliation': 'Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Silviya', 'Initials': 'S', 'LastName': 'Balabanova', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Taylor', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Brown', 'Affiliation': ""Addenbrooke's Hospital NHS Foundation Trust, Cambridge, UK.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Hindley', 'Affiliation': 'Bolton NHS Foundation Trust, Royal Bolton Hospital, Lancashire, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Howell', 'Affiliation': 'Department of Neurology, Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Maguire', 'Affiliation': 'School of Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Mohanraj', 'Affiliation': 'Salford Royal NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Philip E', 'Initials': 'PE', 'LastName': 'Smith', 'Affiliation': 'The Alan Richens Epilepsy Unit, University Hospital of Wales, Cardiff, Wales, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(21)00246-4'] 3465,33838757,"The SANAD II study of the effectiveness and cost-effectiveness of levetiracetam, zonisamide, or lamotrigine for newly diagnosed focal epilepsy: an open-label, non-inferiority, multicentre, phase 4, randomised controlled trial.","BACKGROUND Levetiracetam and zonisamide are licensed as monotherapy for patients with focal epilepsy, but there is uncertainty as to whether they should be recommended as first-line treatments because of insufficient evidence of clinical effectiveness and cost-effectiveness. We aimed to assess the long-term clinical effectiveness and cost-effectiveness of levetiracetam and zonisamide compared with lamotrigine in people with newly diagnosed focal epilepsy. METHODS This randomised, open-label, controlled trial compared levetiracetam and zonisamide with lamotrigine as first-line treatment for patients with newly diagnosed focal epilepsy. Adult and paediatric neurology services across the UK recruited participants aged 5 years or older (with no upper age limit) with two or more unprovoked focal seizures. Participants were randomly allocated (1:1:1) using a minimisation programme with a random element utilising factor to receive lamotrigine, levetiracetam, or zonisamide. Participants and investigators were not masked and were aware of treatment allocation. SANAD II was designed to assess non-inferiority of both levetiracetam and zonisamide to lamotrigine for the primary outcome of time to 12-month remission. Anti-seizure medications were taken orally and for participants aged 12 years or older the initial advised maintenance doses were lamotrigine 50 mg (morning) and 100 mg (evening), levetiracetam 500 mg twice per day, and zonisamide 100 mg twice per day. For children aged between 5 and 12 years the initial daily maintenance doses advised were lamotrigine 1·5 mg/kg twice per day, levetiracetam 20 mg/kg twice per day, and zonisamide 2·5 mg/kg twice per day. All participants were included in the intention-to-treat (ITT) analysis. The per-protocol (PP) analysis excluded participants with major protocol deviations and those who were subsequently diagnosed as not having epilepsy. Safety analysis included all participants who received one dose of any study drug. The non-inferiority limit was a hazard ratio (HR) of 1·329, which equates to an absolute difference of 10%. A HR greater than 1 indicated that an event was more likely on lamotrigine. The trial is registered with the ISRCTN registry, 30294119 (EudraCt number: 2012-001884-64). FINDINGS 990 participants were recruited between May 2, 2013, and June 20, 2017, and followed up for a further 2 years. Patients were randomly assigned to receive lamotrigine (n=330), levetiracetam (n=332), or zonisamide (n=328). The ITT analysis included all participants and the PP analysis included 324 participants randomly assigned to lamotrigine, 320 participants randomly assigned to levetiracetam, and 315 participants randomly assigned to zonisamide. Levetiracetam did not meet the criteria for non-inferiority in the ITT analysis of time to 12-month remission versus lamotrigine (HR 1·18; 97·5% CI 0·95-1·47) but zonisamide did meet the criteria for non-inferiority in the ITT analysis versus lamotrigine (1·03; 0·83-1·28). The PP analysis showed that 12-month remission was superior with lamotrigine than both levetiracetam (HR 1·32 [97·5% CI 1·05 to 1·66]) and zonisamide (HR 1·37 [1·08-1·73]). There were 37 deaths during the trial. Adverse reactions were reported by 108 (33%) participants who started lamotrigine, 144 (44%) participants who started levetiracetam, and 146 (45%) participants who started zonisamide. Lamotrigine was superior in the cost-utility analysis, with a higher net health benefit of 1·403 QALYs (97·5% central range 1·319-1·458) compared with 1·222 (1·110-1·283) for levetiracetam and 1·232 (1·112, 1·307) for zonisamide at a cost-effectiveness threshold of £20 000 per QALY. Cost-effectiveness was based on differences between treatment groups in costs and QALYs. INTERPRETATION These findings do not support the use of levetiracetam or zonisamide as first-line treatments for patients with focal epilepsy. Lamotrigine should remain a first-line treatment for patients with focal epilepsy and should be the standard treatment in future trials. FUNDING National Institute for Health Research Health Technology Assessment programme.",2021,"Lamotrigine was superior in the cost-utility analysis, with a higher net health benefit of 1·403 QALYs (97·5% central range 1·319-1·458) compared with 1·222 (1·110-1·283) for levetiracetam and 1·232 (1·112, 1·307) for zonisamide at a cost-effectiveness threshold of £20 000 per QALY.","['patients with focal epilepsy', 'newly diagnosed focal epilepsy', 'participants who received one dose of any study drug', 'Adult and paediatric neurology services across the UK recruited participants aged 5 years or older (with no upper age limit) with two or more unprovoked focal seizures', '324 participants randomly assigned to', 'patients with newly diagnosed focal epilepsy', 'For children aged between 5 and 12 years', 'participants with major protocol deviations and those who were subsequently diagnosed as not having epilepsy', 'All participants were included in the intention-to-treat (ITT) analysis', 'people with newly diagnosed focal epilepsy', 'participants aged 12 years or older the initial advised maintenance doses were', '990 participants were recruited between May 2, 2013, and June 20, 2017, and followed up for a further 2 years']","['levetiracetam (n=332), or zonisamide', 'levetiracetam, zonisamide, or lamotrigine', 'zonisamide', 'levetiracetam and zonisamide', 'lamotrigine, levetiracetam, or zonisamide', 'levetiracetam (HR 1·32', 'Lamotrigine', 'Levetiracetam', 'lamotrigine 50 mg (morning) and 100 mg (evening), levetiracetam 500 mg twice per day, and zonisamide', 'levetiracetam or zonisamide', 'levetiracetam and zonisamide with lamotrigine', 'levetiracetam', 'lamotrigine']","['Adverse reactions', 'time to 12-month remission', 'Cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014547', 'cui_str': 'Localization-related epilepsy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0587601', 'cui_str': 'Pediatric neurology service'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1828381', 'cui_str': 'Recommendation - action'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C4517916', 'cui_str': '990'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0078844', 'cui_str': 'zonisamide'}, {'cui': 'C0064636', 'cui_str': 'lamotrigine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1132075', 'cui_str': 'lamotrigine 50 MG'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1126012', 'cui_str': 'Levetiracetam 500 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",320.0,0.595248,"Lamotrigine was superior in the cost-utility analysis, with a higher net health benefit of 1·403 QALYs (97·5% central range 1·319-1·458) compared with 1·222 (1·110-1·283) for levetiracetam and 1·232 (1·112, 1·307) for zonisamide at a cost-effectiveness threshold of £20 000 per QALY.","[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Marson', 'Affiliation': 'Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK. Electronic address: a.g.marson@liverpool.ac.uk.'}, {'ForeName': 'Girvan', 'Initials': 'G', 'LastName': 'Burnside', 'Affiliation': 'Department of Health Data Science, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Appleton', 'Affiliation': ""The Roald Dahl EEG Unit, Alder Hey Children's Health Park, Liverpool, UK.""}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': 'The Walton Centre NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'John Paul', 'Initials': 'JP', 'LastName': 'Leach', 'Affiliation': 'School of Medicine, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Sills', 'Affiliation': 'Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Catrin', 'Initials': 'C', 'LastName': 'Tudur-Smith', 'Affiliation': 'Department of Health Data Science, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Catrin', 'Initials': 'C', 'LastName': 'Plumpton', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, Wales, UK.'}, {'ForeName': 'Dyfrig A', 'Initials': 'DA', 'LastName': 'Hughes', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, Wales, UK.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Williamson', 'Affiliation': 'Department of Health Data Science, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Gus A', 'Initials': 'GA', 'LastName': 'Baker', 'Affiliation': 'Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Silviya', 'Initials': 'S', 'LastName': 'Balabanova', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Taylor', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Brown', 'Affiliation': ""Addenbrooke's Hospital NHS Foundation Trust, Cambridge, UK.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Hindley', 'Affiliation': 'Bolton NHS Foundation Trust, Royal Bolton Hospital, Lancashire, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Howell', 'Affiliation': 'Department of Neurology, Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Maguire', 'Affiliation': 'School of Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Mohanraj', 'Affiliation': 'Salford Royal NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Philip E', 'Initials': 'PE', 'LastName': 'Smith', 'Affiliation': 'The Alan Richens Epilepsy Unit, University Hospital of Wales, Cardiff, Wales, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(21)00247-6'] 3466,33838737,Improved housing versus usual practice for additional protection against clinical malaria in The Gambia (RooPfs): a household-randomised controlled trial.,"BACKGROUND In malaria-endemic areas, residents of modern houses have less malaria than those living in traditional houses. We aimed to assess whether children in The Gambia received an incremental benefit from improved housing, where current best practice of insecticide-treated nets, indoor residual spraying, seasonal malaria chemoprevention in children younger than 5 years, and prompt treatment against clinical malaria was in place. METHODS In this randomised controlled study, 800 households with traditional thatched-roofed houses were randomly selected from 91 villages in the Upper River Region of The Gambia. Within each village, equal numbers of houses were randomly allocated to the control and intervention groups using a sampling frame. Houses in the intervention group were modified with metal roofs and screened doors and windows, whereas houses in the control group received no modifications. In each group, clinical malaria in children aged 6 months to 13 years was monitored by active case detection over 2 years (2016-17). We did monthly collections from indoor light traps to estimate vector densities. Primary endpoints were the incidence of clinical malaria in study children with more than 50% of observations each year and household vector density. The trial is registered at ISRCTN02622179. FINDINGS In June, 2016, 785 houses had one child each recruited into the study (398 in unmodified houses and 402 in modified houses). 26 children in unmodified houses and 28 children in modified houses did not have at least 50% of visits in a year and so were excluded from analysis. 38 children in unmodified houses were recruited after study commencement, as were 21 children in modified houses, meaning 410 children in unmodified houses and 395 in modified houses were included in the parasitological analyses. At the end of the study, 659 (94%) of 702 children were reported to have slept under an insecticide-treated net; 662 (88%) of 755 children lived in houses that received indoor residual spraying; and 151 (90%) of 168 children younger than 5 years had seasonal malaria chemoprevention. Incidence of clinical malaria was 0·12 episodes per child-year in children in the unmodified houses and 0·20 episodes per child-year in the modified houses (unadjusted incidence rate ratio [RR] 1·68 [95% CI 1·11-2·55], p=0·014). Household vector density was 3·30 Anopheles gambiae per house per night in the unmodified houses compared with 3·60 in modified houses (unadjusted RR 1·28 [0·87-1·89], p=0·21). INTERPRETATION Improved housing did not provide protection against clinical malaria in this area of low seasonal transmission with high coverage of insecticide-treated nets, indoor residual spraying, and seasonal malaria chemoprevention. FUNDING Global Health Trials funded by Medical Research Council, UK Department for International Development, and Wellcome Trust.",2021,"INTERPRETATION Improved housing did not provide protection against clinical malaria in this area of low seasonal transmission with high coverage of insecticide-treated nets, indoor residual spraying, and seasonal malaria chemoprevention. ","['38 children in unmodified houses were recruited after study commencement, as were 21 children in modified houses, meaning 410 children in unmodified houses and 395 in modified houses were included in the parasitological analyses', '26 children in unmodified houses and 28 children in modified houses', '800 households with traditional thatched-roofed houses were randomly selected from 91 villages in the Upper River Region of The Gambia', 'In June, 2016, 785 houses had one child each recruited into the study (398 in unmodified houses and 402 in modified houses', 'children younger than 5 years, and prompt treatment against clinical malaria was in place', '702 children were reported to have slept under an insecticide-treated net; 662 (88%) of 755 children lived in houses that received indoor residual spraying; and 151 (90%) of 168 children younger than 5 years had seasonal malaria chemoprevention']","['insecticide-treated nets, indoor residual spraying, seasonal malaria chemoprevention']","['Incidence of clinical malaria', 'incidence of clinical malaria', 'household vector density', 'Household vector density', 'incidence rate ratio [RR']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205468', 'cui_str': 'Parasitologic'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0337050', 'cui_str': 'River'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0016993', 'cui_str': 'The Gambia'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4543807', 'cui_str': 'Clinical malaria'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0021576', 'cui_str': 'Insecticide'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C4517872', 'cui_str': '755'}, {'cui': 'C0553288', 'cui_str': 'Lives with children'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0282515', 'cui_str': 'Prophylactic chemotherapy'}]","[{'cui': 'C0021576', 'cui_str': 'Insecticide'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0282515', 'cui_str': 'Prophylactic chemotherapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4543807', 'cui_str': 'Clinical malaria'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",800.0,0.127532,"INTERPRETATION Improved housing did not provide protection against clinical malaria in this area of low seasonal transmission with high coverage of insecticide-treated nets, indoor residual spraying, and seasonal malaria chemoprevention. ","[{'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Pinder', 'Affiliation': 'Department of Biosciences, Durham University, Durham, UK; Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bradley', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Musa', 'Initials': 'M', 'LastName': 'Jawara', 'Affiliation': 'Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia.'}, {'ForeName': 'Muna', 'Initials': 'M', 'LastName': 'Affara', 'Affiliation': 'Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia; Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany.'}, {'ForeName': 'Lesong', 'Initials': 'L', 'LastName': 'Conteh', 'Affiliation': 'London School of Economics and Political Science, London, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Correa', 'Affiliation': 'Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jeffries', 'Affiliation': 'Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'KEMRI-Wellcome Trust Programme, Kilifi, Kenya and Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Balla', 'Initials': 'B', 'LastName': 'Kandeh', 'Affiliation': 'National Malaria Control Programme, Banjul, The Gambia.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Knudsen', 'Affiliation': 'Royal Danish Academy - Architecture, Design, Conservation, Copenhagen, Denmark.'}, {'ForeName': 'Yekini', 'Initials': 'Y', 'LastName': 'Olatunji', 'Affiliation': 'Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Sicuri', 'Affiliation': 'School of Public Health, Imperial College London, London, UK; ISGlobal, Hospital Clínic, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': ""D'Alessandro"", 'Affiliation': 'Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia; Department of Disease Control, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Steve W', 'Initials': 'SW', 'LastName': 'Lindsay', 'Affiliation': 'Department of Biosciences, Durham University, Durham, UK; Department of Disease Control, London School of Hygiene & Tropical Medicine, London, UK. Electronic address: s.w.lindsay@durham.ac.uk.'}]",The Lancet. Planetary health,['10.1016/S2542-5196(21)00002-4'] 3467,33844393,Fructose intolerance is not associated with malabsorption in patients with functional gastrointestinal disorders.,"BACKGROUND Symptoms following fructose ingestion, or fructose intolerance, are common in patients with functional gastrointestinal disorders (FGID) and are generally attributed to intestinal malabsorption. The relationships between absorption, symptoms, and intestinal gas production following fructose ingestion were studied in patients with FGID. METHODS Thirty FGID patients ingested a single dose of fructose 35 g or water in a randomized, double-blind, crossover study. Blood and breath gas samples were collected, and gastrointestinal symptoms rated. Plasma fructose metabolites and short-chain fatty acids were quantified by targeted liquid chromatography-tandem mass spectrometry. Patients were classified as fructose intolerant or tolerant based on symptoms following fructose ingestion. KEY RESULTS The median (IQR) areas under the curve of fructose plasma concentrations within the first 2 h (AUC 0-2 h ) after fructose ingestion were similar for patients with and without fructose intolerance (578 (70) µM·h vs. 564 (240) µM·h, respectively, p = 0.39), as well as for the main fructose metabolites. There were no statistically significant correlations between the AUC 0-2 h of fructose or its metabolites concentrations and the AUCs of symptoms, breath hydrogen, and breath methane. However, the AUCs of symptoms correlated significantly and positively with the AUC 0-2 h of hydrogen and methane breath concentrations (r = 0.73, r = 0.62, respectively), and the AUCs of hydrogen and methane concentrations were greater in the fructose-intolerant than in the fructose-tolerant patients after fructose ingestion (p ≤ 0.02). CONCLUSIONS & INFERENCES Fructose intolerance in FGID is not related to post-ingestion plasma concentrations of fructose and its metabolites. Factors other than malabsorption, such as altered gut microbiota or sensory function, may be important mechanisms.",2021,"There were no statistically significant correlations between the AUC 0-2 h of fructose or its metabolites concentrations and the AUCs of symptoms, breath hydrogen, and breath methane.","['patients with functional gastrointestinal disorders', 'Thirty FGID patients ingested a single dose of', 'patients with FGID', 'Patients were classified as fructose intolerant or tolerant based on symptoms following fructose ingestion', 'patients with functional gastrointestinal disorders (FGID']",['fructose 35\xa0g or water'],"['Plasma fructose metabolites and short-chain fatty acids', 'AUCs of hydrogen and methane concentrations', 'median (IQR) areas under the curve of fructose plasma concentrations', 'AUC 0-2\xa0h of fructose or its metabolites concentrations and the AUCs of symptoms, breath hydrogen, and breath methane', 'Blood and breath gas samples', 'absorption, symptoms, and intestinal gas production following fructose ingestion', 'hydrogen and methane breath concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0559031', 'cui_str': 'Functional disorder of gastrointestinal tract'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C0025617', 'cui_str': 'Methane'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0520912', 'cui_str': 'Intestinal gas'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]",30.0,0.0973164,"There were no statistically significant correlations between the AUC 0-2 h of fructose or its metabolites concentrations and the AUCs of symptoms, breath hydrogen, and breath methane.","[{'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Wilder-Smith', 'Affiliation': 'Gastroenterology Group Practice, Brain-Gut Research Group, Bern, Switzerland.'}, {'ForeName': 'Sze Han', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Pharmacy, National University of Singapore, Singapore City, Singapore.'}, {'ForeName': 'Søren Schou', 'Initials': 'SS', 'LastName': 'Olesen', 'Affiliation': 'Department of Gastroenterology and Hepatology, Mech-Sense, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Jing Yi', 'Initials': 'JY', 'LastName': 'Low', 'Affiliation': 'Department of Pharmacy, National University of Singapore, Singapore City, Singapore.'}, {'ForeName': 'Dorinda Yan Qin', 'Initials': 'DYQ', 'LastName': 'Kioh', 'Affiliation': 'Department of Pharmacy, National University of Singapore, Singapore City, Singapore.'}, {'ForeName': 'Ronaldo', 'Initials': 'R', 'LastName': 'Ferraris', 'Affiliation': 'Department of Pharmacology & Physiology, New Jersey Medical School, Newark, NJ, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Materna', 'Affiliation': 'Gastroenterology Group Practice, Brain-Gut Research Group, Bern, Switzerland.'}, {'ForeName': 'Eric Chun Yong', 'Initials': 'ECY', 'LastName': 'Chan', 'Affiliation': 'Department of Pharmacy, National University of Singapore, Singapore City, Singapore.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.14150'] 3468,33844373,Erythritol air-polishing in the non-surgical treatment of peri-implantitis; a randomized controlled trial.,"OBJECTIVES To compare erythritol air-polishing with piezoelectric ultrasonic scaling in the non-surgical treatment of peri-implantitis. MATERIAL AND METHODS Eighty patients (n=139 implants) with peri-implantitis (probing pocket depth (PPD) ≥5mm, marginal bone loss (MBL) ≥2mm as compared to bone level at implant placement, bleeding and/or suppuration on probing (BoP/SoP)) were randomly allocated to air-polishing or ultrasonic treatment. The primary outcome was mean BoP (%) at 3 months after therapy (T3). Secondary outcomes were mean SoP (%), plaque score (Plq) (%), PPD (mm), MBL (mm), full mouth periodontal scores (FMPS) (%), levels of 8 classical periodontal pathogens and treatment pain/discomfort (Visual Analog Scale, VAS). Patients who were considered successful at T3 were additionally assessed at 6, 9 and 12 months. Differences between both groups were analysed using multilevel statistics. RESULTS Three months after therapy, no significant difference in mean BoP (%) between the air-polishing and ultrasonic therapy was found (crude analysis β (95% CI) -0.037 (-0.147; 0.073), p = 0.380). Neither secondary outcomes SoP (%), Plq (%), PPD (mm), MBL (mm), FMPS (%) and periodontal pathogens showed significant differences. Treatment pain/discomfort was low in both groups (VAS score air-polishing group 2.1 (±1.9), ultrasonic 2.6 (±1.9); p = 0.222). All successfully treated patients at T3 (18.4%) were still considered successful at 12 months follow-up. CONCLUSIONS Erythritol air-polishing seems as effective as piezoelectric ultrasonic scaling in the non-surgical treatment of peri-implantitis, in terms of clinical, radiographical and microbiological parameters. However, neither of the proposed therapies effectively resolved peri-implantits. Hence, the majority of patients required further surgical treatment.",2021,"Three months after therapy, no significant difference in mean BoP (%) between the air-polishing and ultrasonic therapy was found (crude analysis β (95% CI) -0.037","['Eighty patients (n=139 implants) with peri-implantitis (probing pocket depth (PPD) ≥5mm, marginal bone loss (MBL) ≥2mm as compared to bone level at implant placement, bleeding and/or suppuration on probing (BoP/SoP']","['Erythritol air-polishing', 'air-polishing or ultrasonic treatment', 'erythritol air-polishing with piezoelectric ultrasonic scaling']","['mean SoP (%), plaque score (Plq) (%), PPD (mm), MBL (mm), full mouth periodontal scores (FMPS) (%), levels of 8 classical periodontal pathogens and treatment pain/discomfort (Visual Analog Scale, VAS', 'mean BoP', 'Plq (%), PPD (mm), MBL (mm), FMPS (%) and periodontal pathogens', 'Treatment pain/discomfort']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C2936258', 'cui_str': 'Dental peri-implantitis'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0038862', 'cui_str': 'Suppurative inflammation'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}]","[{'cui': 'C0014757', 'cui_str': 'Erythritol'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0065661', 'cui_str': 'Mannose-binding protein'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C1291732', 'cui_str': 'Treatment pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}]",,0.0558323,"Three months after therapy, no significant difference in mean BoP (%) between the air-polishing and ultrasonic therapy was found (crude analysis β (95% CI) -0.037","[{'ForeName': 'Diederik F M', 'Initials': 'DFM', 'LastName': 'Hentenaar', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Yvonne C M', 'Initials': 'YCM', 'LastName': 'De Waal', 'Affiliation': 'Center for Dentistry and Oral Hygiene, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Roy E', 'Initials': 'RE', 'LastName': 'Stewart', 'Affiliation': 'Department of Health Sciences, Community and Occupational Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Arie Jan', 'Initials': 'AJ', 'LastName': 'Van Winkelhoff', 'Affiliation': 'Center for Dentistry and Oral Hygiene, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Henny J A', 'Initials': 'HJA', 'LastName': 'Meijer', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Gerry M', 'Initials': 'GM', 'LastName': 'Raghoebar', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}]",Clinical oral implants research,['10.1111/clr.13757'] 3469,33844367,Determinants of Kidney Transplant Candidates' Decision to Accept Organ Donor Intervention Transplants and Participate in Post-Transplant Research: A Conjoint Analysis.,"Deceased organ donor intervention research aims to increase organ quality and quantity for transplantation. We assessed the proportion of kidney transplant candidates who would accept ""intervention organs,"" participate in organ intervention research, and factors influencing acceptance. Kidney transplant candidates were presented 12 hypothetical scenarios, that varied donor age, predicted waiting time to receive another organ offer, and research risk to the organ. Candidates were also randomly assigned to one of two conditions varying recipient risk. For each scenario, candidates agreed to accept the intervention organ or remain waitlisted. We fit a multivariable logit model to determine the association between scenario attributes and the acceptance decision. Of 249 participants, most (96%) accepted intervention organs under some or all conditions. Factors independently associated with candidates' greater likelihood of accepting an intervention organ included: low risk to the kidney from the intervention (OR 20.53 [95% Confidence Interval (CI), 13.91-30.29]); younger donor age (OR 3.72 [95% CI, 2.83-4.89]), longer time until the next organ offer (OR 3.48 [95% CI, 2.65-4.57]), and greater trust in their transplant physician (OR 1.03 [95% CI, 1.00-1.06. Candidates with a lower likelihood of acceptance had been waitlisted longer (OR 0.97 per month [95% CI, 0.96-0.99]), and were Black (OR 0.21 [95% CI, 0.08-0.55]). Most candidates would accept an intervention organ, which should encourage transplant leaders to conduct deceased donor organ intervention trials.",2021,"Candidates with a lower likelihood of acceptance had been waitlisted longer (OR 0.97 per month [95% CI, 0.96-0.99]), and were Black (OR 0.21","[""Kidney Transplant Candidates' Decision to Accept Organ Donor Intervention Transplants and Participate in Post-Transplant Research"", 'Of 249 participants, most (96%) accepted intervention organs under some or all conditions']",[],"['longer time until the next organ offer', 'organ quality and quantity for transplantation']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0029206', 'cui_str': 'Organ donor'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",[],"[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]",249.0,0.0491123,"Candidates with a lower likelihood of acceptance had been waitlisted longer (OR 0.97 per month [95% CI, 0.96-0.99]), and were Black (OR 0.21","[{'ForeName': 'Elisa J', 'Initials': 'EJ', 'LastName': 'Gordon', 'Affiliation': 'Department of Surgery, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Abt', 'Affiliation': 'Department of Surgery, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Jungwha', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Preventive Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Knopf', 'Affiliation': 'Center for Health Services and Outcomes Research, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Phillips', 'Affiliation': 'Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Bermudez', 'Affiliation': 'Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Lakshman', 'Initials': 'L', 'LastName': 'Krishnamurthi', 'Affiliation': 'Department of Marketing, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Huseyin Sami', 'Initials': 'HS', 'LastName': 'Karaca', 'Affiliation': 'Department of Management, Bogazici University, Istanbul, Turkey.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Veatch', 'Affiliation': 'Kennedy Institute of Ethics, Georgetown University, Washington, DC, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Knight', 'Affiliation': 'American Association of Kidney Patients.'}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Conway', 'Affiliation': 'American Association of Kidney Patients.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Dunn', 'Affiliation': 'Donor Alliance, Denver, CO, USA.'}, {'ForeName': 'Peter P', 'Initials': 'PP', 'LastName': 'Reese', 'Affiliation': 'Department of Medicine; Renal-Electrolyte & Hypertension Division, Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania, Philadelphia, PA, USA.'}]",Clinical transplantation,['10.1111/ctr.14316'] 3470,33844358,Simple and reliable protocol for identifying talented junior players in team sports using small-sided games.,"We designed and tested a protocol for measuring the performance of individuals in small-sided soccer games. We tested our protocol on three different groups of youth players from elite Brazilian football academies. Players in each group played a series of 3v3 games, in which individuals were randomly assigned into new teams and against new opponents for each game. We calculated each individual's average individual goals scored, goals scored by team-mates, goals conceded, and net team goals per game. Our protocol was consistent across days and repeatable across groups, with ICCs of 0.57 to 0.69 for average net goals per game across testing days. Players could achieve high success by scoring goals or ensuring their team concede few goals. We also calculated the first and second dimension of a principal component analysis based on each player's number of goals scored, goals scored by team-mates, and number of goals conceded per game. Players that were overall high performers had higher PC 1 scores, while PC 2 scores represented the type of contribution made by a player to overall performance. Positive PC 2 values were indicative of high number of individual goals while negative values were associated with more goals from team-mates and fewer conceded goals. Our design allows coaches and scouts to easily collect a robust metric of individual performance using randomly-designed, small-sided games. We also provide simulations that allows one to apply our methodology for individual talent identification to other small-sided games in any team sport.",2021,"Players that were overall high performers had higher PC 1 scores, while PC 2 scores represented the type of contribution made by a player to overall performance.","['youth players from elite Brazilian football academies', 'individuals in small-sided soccer games', 'talented junior players in team sports using small-sided games']",[],[],"[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0038039', 'cui_str': 'Sport'}]",[],[],,0.115846,"Players that were overall high performers had higher PC 1 scores, while PC 2 scores represented the type of contribution made by a player to overall performance.","[{'ForeName': 'Robbie S', 'Initials': 'RS', 'LastName': 'Wilson', 'Affiliation': 'School of Biological Sciences, The University of Queensland, St Lucia, QLD, 4072, Australia.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Hunter', 'Affiliation': 'School of Biological Sciences, The University of Queensland, St Lucia, QLD, 4072, Australia.'}, {'ForeName': 'Thiago V', 'Initials': 'TV', 'LastName': 'Camata', 'Affiliation': 'School of Biological Sciences, The University of Queensland, St Lucia, QLD, 4072, Australia.'}, {'ForeName': 'Charles S P', 'Initials': 'CSP', 'LastName': 'Foster', 'Affiliation': 'School of Medical Sciences, University of New South Wales, NSW, Australia.'}, {'ForeName': 'Gabriella R', 'Initials': 'GR', 'LastName': 'Sparkes', 'Affiliation': 'School of Biological Sciences, The University of Queensland, St Lucia, QLD, 4072, Australia.'}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Moura', 'Affiliation': 'Sport Sciences Department, State University of Londrina, Londrina, Brazil.'}, {'ForeName': 'Paulo R P', 'Initials': 'PRP', 'LastName': 'Santiago', 'Affiliation': 'School of Physical Education and Sports of Ribeirão Preto, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Nicholas M A', 'Initials': 'NMA', 'LastName': 'Smith', 'Affiliation': 'School of Biological Sciences, The University of Queensland, St Lucia, QLD, 4072, Australia.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13969'] 3471,33844276,An equivalence analysis of provider education in youth mental health care.,"OBJECTIVE To test for equivalence between providers with and without advanced degrees in multiple domains related to delivery of evidence-based treatment. DATA SOURCE Provider and client data from an effectiveness trial of Alternatives for Families: A Cognitive Behavioral Therapy (AF-CBT) in a major metropolitan area in the United States. STUDY DESIGN We tested for equivalence between providers (N = 182) with and without advanced degrees in treatment-related knowledge, practices, and attitudes; job demands and stress; and training engagement and trainer-rated competence in AF-CBT. We also conducted exploratory analyses to test for equivalence in family clinical outcomes. DATA COLLECTION Providers completed measures prior to randomization and at 6-month follow-up, after completion of training and consultation in AF-CBT. Children and caregivers completed assessments at 0, 6, 12, and 18 months. PRINCIPAL FINDINGS Providers without advanced degrees were largely non-inferior to those with advanced degrees in treatment-related knowledge, practices, and attitudes, while findings for job demands and stress were mixed. Providers without advanced degrees were non-inferior to providers with advanced degrees in consultation attendance (B = -1.42; confidence interval (CI) = -3.01-0.16; margin of equivalence (Δ) = 2), number of case presentations (B = 0.64; CI = -0.49-1.76; Δ = 2), total training hours (B = -4.57; CI = -10.52-1.37; Δ = 3), and trainer-rated competence in AF-CBT (B = -0.04; CI = -3.04-2.96; Δ = 4), and they were significantly more likely to complete training (odds ratio = 0.66; CI = 0.10-0.96; Δ = 30%). Results for clinical outcomes were largely inconclusive. CONCLUSIONS Provider-level outcomes for those with and without advanced degrees were generally comparable. Additional research is needed to examine equivalence in clinical outcomes. Expanding evidence-based treatment training to individuals without advanced degrees may help to reduce workforce shortages and improve reach of evidence-based treatments.",2021,"Providers without advanced degrees were non-inferior to providers with advanced degrees in consultation attendance (B = -1.42; confidence interval (CI) = -3.01-0.16; margin of equivalence (Δ) = 2), number of case presentations (B = 0.64; CI = -0.49-1.76; Δ = 2), total training hours (B = -4.57; CI = -10.52-1.37; Δ = 3), and trainer-rated competence in AF-CBT (B = -0.04; CI = -3.04-2.96; Δ = 4), and they were significantly more likely to complete training (odds ratio = 0.66; CI = 0.10-0.96; Δ = 30%).","['providers (N\xa0=\xa0182) with and without advanced degrees in treatment-related knowledge, practices, and attitudes; job demands and stress; and training engagement and trainer-rated competence in AF-CBT', 'Families', 'youth mental health care']",['Cognitive Behavioral Therapy (AF-CBT'],['number of case presentations'],"[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}]",182.0,0.0985163,"Providers without advanced degrees were non-inferior to providers with advanced degrees in consultation attendance (B = -1.42; confidence interval (CI) = -3.01-0.16; margin of equivalence (Δ) = 2), number of case presentations (B = 0.64; CI = -0.49-1.76; Δ = 2), total training hours (B = -4.57; CI = -10.52-1.37; Δ = 3), and trainer-rated competence in AF-CBT (B = -0.04; CI = -3.04-2.96; Δ = 4), and they were significantly more likely to complete training (odds ratio = 0.66; CI = 0.10-0.96; Δ = 30%).","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'McGuier', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Rothenberger', 'Affiliation': 'Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Abbey', 'Initials': 'A', 'LastName': 'Friedman', 'Affiliation': 'Western Psychiatric Hospital, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Kolko', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}]",Health services research,['10.1111/1475-6773.13659'] 3472,33845626,Efficacy of CO-OP Approach With and Without Parental Coaching: RCT Study Protocol.,"BACKGROUND. Developmental coordination disorder (DCD) leads to decreased occupational performance and restricted participation. Cognitive Orientation to daily Occupational Performance Approach (CO-OP) is effective, and as parental support is a key element, it seems relevant to investigate. PURPOSE. To describe a study protocol that will compare CO-OP with and without Occupational Performance Coaching (OPC) on activity and participation of children with DCD. METHOD. Randomized controlled with seven to 12-year-olds, assigned to either experimental (CO-OP+OPC) or control (CO-OP) group, both receiving traditional CO-OP, with four additional parental group sessions for the experimental group. KEY ISSUES. Actual and perceived occupational performance and satisfaction of children's chosen goals and participation, motor performance and executive function. Measures will be obtained at baseline, post-intervention, and at 3-month follow-up. IMPLICATIONS. Detailed description of an intervention protocol may help further replication and may contribute to clarify if a boost on parents' participation promotes better outcomes for children with DCD. TRIAL REGISTRATION. Clinical Trials, NCT02893852. (https://clinicaltrials.gov/ct2/show/NCT02893852).",2021,"Cognitive Orientation to daily Occupational Performance Approach (CO-OP) is effective, and as parental support is a key element, it seems relevant to investigate. PURPOSE. ",['children with DCD'],"['experimental (CO-OP+OPC) or control (CO-OP) group, both receiving traditional CO-OP', 'Cognitive Orientation to daily Occupational Performance Approach (CO-OP', 'CO-OP with and without Occupational Performance Coaching (OPC', 'CO-OP Approach']","[""Actual and perceived occupational performance and satisfaction of children's chosen goals and participation, motor performance and executive function""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011757', 'cui_str': 'Developmental coordination disorder'}]","[{'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",,0.0551239,"Cognitive Orientation to daily Occupational Performance Approach (CO-OP) is effective, and as parental support is a key element, it seems relevant to investigate. PURPOSE. ","[{'ForeName': 'Clarice Ribeiro Soares', 'Initials': 'CRS', 'LastName': 'Araújo', 'Affiliation': ''}, {'ForeName': 'Ana Amélia', 'Initials': 'AA', 'LastName': 'Cardoso', 'Affiliation': ''}, {'ForeName': 'Lívia de Castro', 'Initials': 'LC', 'LastName': 'Magalhães', 'Affiliation': ''}]",Canadian journal of occupational therapy. Revue canadienne d'ergotherapie,['10.1177/00084174211005889'] 3473,33845623,The influence of hydroxyapatite coating on continuous migration of a Zweymuller-type hip stem: a double-blinded randomised RSA trial with 5-year follow-up.,"BACKGROUND AND PURPOSE Adding hydroxyapatite to a stem to enhance ingrowth is a matter of debate, even less is known about the long-term effect on stability by adding hydroxyapatite (HA). Continuous migration in the first 2-5 years is an indicator of failed osteointegration or pending failure, enhancing the risk of loosening within 10 years after initial surgery. We performed a double-blinded randomised RSA trial with 5-year follow-up, to compare and analyse migration characteristics of the hydroxyapatite uncoated (HA-) and hydroxyapatite coated (HA+) Zweymuller-type hip stem. PATIENTS AND METHODS In this single-centre prospective randomised controlled trial 51 patients were randomised to receive either a HA- or a HA+ Zweymuller-type hip stem during total hip replacement. After 5 years, 35 patients were still eligible for follow-up evaluation. The migration pattern was measured by use of radio stereometric analysis (RSA) images up to 2 years to evaluate short-term migration, additionally RSA images were obtained 5 years postoperatively to assess late-term and continuous migration. Furthermore, the improvement of clinical outcome was analysed by HSS and HOOS ADL and pain subscales preoperative and after 5 years. RESULTS After initial settling of the implant, no significant migration occurred up to 5 years post-surgery for HA+ as well as HA- prostheses. Continuous migration within the 2-5 years' time interval was not observed for both HA+ nor the HA- group in all directions ( p <  0.05). No significant difference between both groups was observed ( p <  0.10). In both groups the HHS and HOOS improved significantly at 5 years compared to baseline for both groups. Improvement was not altered by the hydroxyapatite coating. No significant difference between both groups was observed ( p >  0.58). CONCLUSIONS Addition of a hydroxyapatite coating did not influence the migration 5 years postoperatively for the Zweymuller-type hip stem.Clinical Trial Protocol number: NL 23524.048.08.",2021,Continuous migration within the 2-5 years' time interval was not observed for both HA+ nor the HA- group in all directions ( p <  0.05).,"['Zweymuller-type hip stem', '51 patients', '35 patients were still eligible for follow-up evaluation']","['HA- or a HA+ Zweymuller-type hip stem during total hip replacement', 'hydroxyapatite uncoated (HA-) and hydroxyapatite coated (HA', 'hydroxyapatite coating']","['HSS and HOOS ADL and pain subscales preoperative', 'HHS and HOOS']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]","[{'cui': 'C0020326', 'cui_str': 'Hydroxyapatite Derivatives'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0018522', 'cui_str': 'Hallermann-Streiff syndrome'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0041711', 'cui_str': 'United States. Dept. of Health and Human Services'}]",51.0,0.106112,Continuous migration within the 2-5 years' time interval was not observed for both HA+ nor the HA- group in all directions ( p <  0.05).,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hoornenborg', 'Affiliation': 'Xpert Clinics, Orthopaedic Surgery, Amsterdam, The Netherlands.'}, {'ForeName': 'Annelieke M C', 'Initials': 'AMC', 'LastName': 'Schweden', 'Affiliation': 'Xpert Clinics, Orthopaedic Surgery, Amsterdam, The Netherlands.'}, {'ForeName': 'Inger N', 'Initials': 'IN', 'LastName': 'Sierevelt', 'Affiliation': 'Xpert Clinics, Orthopaedic Surgery, Amsterdam, The Netherlands.'}, {'ForeName': 'Harm M', 'Initials': 'HM', 'LastName': 'van der Vis', 'Affiliation': 'Xpert Clinics, Orthopaedic Surgery, Amsterdam, The Netherlands.'}, {'ForeName': 'Gmmj', 'Initials': 'G', 'LastName': 'Kerkhoffs', 'Affiliation': 'Amsterdam UMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Haverkamp', 'Affiliation': 'Xpert Clinics, Orthopaedic Surgery, Amsterdam, The Netherlands.'}]",Hip international : the journal of clinical and experimental research on hip pathology and therapy,['10.1177/11207000211006782'] 3474,33845615,"Capsular closure versus unrepaired interportal capsulotomy after hip arthroscopy in patients with femoroacetabular impingement, results of a patient-blinded randomised controlled trial.","BACKGROUND Hip capsular management after hip arthroscopy remains a topic of debate. Most available current literature is of poor quality and are retrospective or cohort studies. As of today, no clear consensus exists on capsular management after hip arthroscopy. PURPOSE To evaluate the effect of routine capsular closure versus unrepaired capsulotomy after interportal capsulotomy measured with NRS pain and the Copenhagen Hip and Groin Outcome Score (HAGOS). MATERIALS AND METHODS All eligible patients with femoroacetabular impingement who opt for hip arthroscopy ( n  = 116) were randomly assigned to one of both treatment groups and were operated by a single surgeon. Postoperative pain was measured with the NRS score weekly the first 12 weeks after surgery. The HAGOS questionnaire was measured at 12 and 52 weeks postoperatively. RESULTS Baseline characteristics and operation details were comparable between treatment groups. Regarding the NRS pain no significant difference was found between groups at any point the first 12 weeks after surgery ( p  = 0.67). Both groups significantly improved after surgery ( p  < 0.001). After 3 months follow-up there were no differences between groups for the HAGOS questionnaire except for the domain sport ( p  = 0.02) in favour of the control group. After 12 months follow-up there were no differences between both treatment groups on all HAGOS domains ( p   >  0.05). CONCLUSIONS The results of this randomised controlled trial show highest possible evidence that there is no reason for routinely capsular closure after interportal capsulotomy at the end of hip arthroscopy. TRIAL REGISTRATION This trial was registered at the CCMO Dutch Trial Register: NL55669.048.15.",2021,"After 12 months follow-up there were no differences between both treatment groups on all HAGOS domains ( p   >  0.05). ","['patients with femoroacetabular impingement', 'All eligible patients with femoroacetabular impingement who opt for hip arthroscopy ( n \u2009=\u2009116']","['Capsular closure versus unrepaired interportal capsulotomy after hip arthroscopy', 'routine capsular closure versus unrepaired capsulotomy after interportal capsulotomy']","['NRS pain and the Copenhagen Hip and Groin Outcome Score (HAGOS', 'NRS pain', 'HAGOS questionnaire', 'Postoperative pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2936290', 'cui_str': 'Femoral acetabular impingement'}, {'cui': 'C0186190', 'cui_str': 'Diagnostic arthroscopy of hip joint'}, {'cui': 'C4517541', 'cui_str': '116'}]","[{'cui': 'C0205151', 'cui_str': 'Capsular'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0186190', 'cui_str': 'Diagnostic arthroscopy of hip joint'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0018246', 'cui_str': 'Inguinal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",116.0,0.140255,"After 12 months follow-up there were no differences between both treatment groups on all HAGOS domains ( p   >  0.05). ","[{'ForeName': 'Niels H', 'Initials': 'NH', 'LastName': 'Bech', 'Affiliation': 'Specialized Center of Orthopaedic Research & Education (SCORE), Department of Orthopaedic Surgery, Xpert Orthopaedic Surgery Clinic, Amsterdam, The Netherlands.'}, {'ForeName': 'Inger N', 'Initials': 'IN', 'LastName': 'Sierevelt', 'Affiliation': 'Specialized Center of Orthopaedic Research & Education (SCORE), Department of Orthopaedic Surgery, Xpert Orthopaedic Surgery Clinic, Amsterdam, The Netherlands.'}, {'ForeName': 'Sheryl', 'Initials': 'S', 'LastName': 'de Waard', 'Affiliation': 'Specialized Center of Orthopaedic Research & Education (SCORE), Department of Orthopaedic Surgery, Xpert Orthopaedic Surgery Clinic, Amsterdam, The Netherlands.'}, {'ForeName': 'Boudijn S H', 'Initials': 'BSH', 'LastName': 'Joling', 'Affiliation': 'Specialized Center of Orthopaedic Research & Education (SCORE), Department of Orthopaedic Surgery, Xpert Orthopaedic Surgery Clinic, Amsterdam, The Netherlands.'}, {'ForeName': 'Gino M M J', 'Initials': 'GMMJ', 'LastName': 'Kerkhoffs', 'Affiliation': 'Department of Orthopaedic Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam Movement Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Haverkamp', 'Affiliation': 'Specialized Center of Orthopaedic Research & Education (SCORE), Department of Orthopaedic Surgery, Xpert Orthopaedic Surgery Clinic, Amsterdam, The Netherlands.'}]",Hip international : the journal of clinical and experimental research on hip pathology and therapy,['10.1177/11207000211005762'] 3475,33845522,Effectiveness of antibiotic prophylaxis in patients with centipede stings: a randomized controlled trial.,"OBJECTIVE Centipede stings are a common problem in tropical countries. Current treatment guidelines do not include recommendations for antibiotic prophylaxis to prevent the associated bacterial infection since no previous study has assessed the effectiveness of antibiotic treatment in patients bitten by centipedes. Thus, this study aimed to compare the effectiveness of antibiotic prophylaxis over placebo for the skin infections that occur after a centipede sting. METHODS In this randomized, double-blind, multi-center clinical trial conducted in the emergency departments in four hospitals, patients with any history of a centipede sting were prospectively enrolled and divided randomly into two groups. One group received dicloxacillin and the other a placebo. The primary outcome was the incidence of wound infection 3 to 5 days after the centipede sting. RESULTS From December 2014 to October 2015, a total of 83 patients were enrolled in the study and were randomized into antibiotic (n=43) and placebo (n=40) groups. Two patients in the antibiotic group developed wound infections, while none showed wound infection in the placebo group (5% vs. 0%). The wound infection rate did not differ significantly between the two groups (P=0.496). CONCLUSION Antibiotic prophylaxis may be unnecessary in cases of centipede stings. Proper wound care is an adequate and appropriate treatment for patients with centipede stings. However, the patient should be re-evaluated for detection of secondary bacterial infection.",2021,"The wound infection rate did not differ significantly between the two groups (P=0.496). ","['n=40) groups', 'From December 2014 to October 2015, a total of 83 patients were enrolled in the study and were randomized into antibiotic (n=43) and', 'patients with centipede stings', 'patients bitten by centipedes', 'emergency departments in four hospitals, patients with any history of a centipede sting']","['antibiotic prophylaxis', 'dicloxacillin', 'antibiotic prophylaxis over placebo', 'placebo']","['wound infection rate', 'incidence of wound infection 3 to 5 days after the centipede sting', 'wound infection', 'wound infections']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0323819', 'cui_str': 'Class Chilopoda'}, {'cui': 'C0038340', 'cui_str': 'Sting'}, {'cui': 'C0005658', 'cui_str': 'Bite wound'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0012093', 'cui_str': 'Dicloxacillin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0323819', 'cui_str': 'Class Chilopoda'}, {'cui': 'C0038340', 'cui_str': 'Sting'}]",83.0,0.320505,"The wound infection rate did not differ significantly between the two groups (P=0.496). ","[{'ForeName': 'Chanon', 'Initials': 'C', 'LastName': 'Changratanakorn', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Napasawan', 'Initials': 'N', 'LastName': 'Fasawang', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Boriboon', 'Initials': 'B', 'LastName': 'Chenthanakit', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Pakpoom', 'Initials': 'P', 'LastName': 'Tansanthong', 'Affiliation': 'Department of Emergency Medicine, Wiang Nong Long Hospital, Lamphun, Thailand.'}, {'ForeName': 'Chanikarn', 'Initials': 'C', 'LastName': 'Mapairoje', 'Affiliation': 'Department of Emergency Medicine, Banthi Hospital, Lamphun, Thailand.'}, {'ForeName': 'Ratree', 'Initials': 'R', 'LastName': 'Tunud', 'Affiliation': 'Department of Emergency Medicine, Li Hospital, Lamphun, Thailand.'}, {'ForeName': 'Annop', 'Initials': 'A', 'LastName': 'Pipopwongpisan', 'Affiliation': 'Department of Emergency Medicine, Li Hospital, Lamphun, Thailand.'}, {'ForeName': 'Borwon', 'Initials': 'B', 'LastName': 'Wittayachamnankul', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}]",Clinical and experimental emergency medicine,['10.15441/ceem.20.110'] 3476,33845473,Early PARacetamol (EPAR) Trial: A Randomized Controlled Trial of Early Paracetamol to Promote Closure of the Ductus Arteriosus in Preterm Infants.,"INTRODUCTION This study aimed to investigate whether early treatment with paracetamol reduces the number of infants requiring intervention for patent ductus arteriosus (PDA) and assess the safety profile of paracetamol during the early postnatal period. METHODS This was a double-blind, parallel, randomized, placebo-controlled trial. Preterm infants born at <29-week gestation with a ductus arteriosus >0.9 mm at 6 h of life were randomized to either (1) intravenous paracetamol (15 mg/kg initially and then 7.5 mg/kg every 6 h) or (2) intravenous dextrose for 5 days. The primary outcome was the need for any intervention for PDA up to 5 days. Secondary outcomes included ductal closure at 5 days, ductal size at 48 h, ductal reopening, mortality, and significant morbidities. RESULTS Of 58 infants randomized, 29 were allocated to the intervention and 29 to the control group. The trial was stopped for benefit at 50% recruitment after reaching the prespecified stopping criteria. Less infants in the intervention group required intervention for PDA up to 5 days (6 [21%] vs. 17 [59%] infants [p = 0.003]; relative risk reduction 0.35 [95% CI 0.16-0.77; NNT 2.6]). The intervention group had a higher rate of ductal closure (20 [69%] vs. 8 [28%] infants [p = 0.002]) and smaller ductal size (1.0 mm [±0.8] vs. 1.4 mm [±0.9]; p = 0.04). Three deaths occurred (2 in the intervention group), which were not attributed to the intervention. No other adverse events were reported. DISCUSSION/CONCLUSION Early paracetamol treatment reduced the number of infants requiring intervention for PDA. Short-term safety data were reassuring, acknowledging the small number of infants involved in the study.",2021,The intervention group had a higher rate of ductal closure (20 [69%] vs. 8 [28%] infants [p = 0.002]) and smaller ductal size (1.0 mm [±0.8] vs. 1.4 mm [±0.9]; p = 0.04).,"['Preterm infants born at <29-week gestation with a ductus arteriosus >0.9 mm at 6 h of life', '58 infants randomized', 'Preterm Infants', 'infants requiring intervention for patent ductus arteriosus (PDA']","['intravenous dextrose', 'placebo', 'paracetamol', 'Paracetamol']","['need for any intervention for PDA', 'ductal closure at 5 days, ductal size at 48 h, ductal reopening, mortality, and significant morbidities', 'rate of ductal closure', 'smaller ductal size', 'deaths', 'adverse events']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0013273', 'cui_str': 'Structure of ductus arteriosus'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",58.0,0.378851,The intervention group had a higher rate of ductal closure (20 [69%] vs. 8 [28%] infants [p = 0.002]) and smaller ductal size (1.0 mm [±0.8] vs. 1.4 mm [±0.9]; p = 0.04).,"[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Schindler', 'Affiliation': 'Department of Newborn Care, Royal Hospital for Women, Sydney, New South Wales, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Smyth', 'Affiliation': 'Department of Newborn Care, Royal Hospital for Women, Sydney, New South Wales, Australia.'}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Bolisetty', 'Affiliation': 'Department of Newborn Care, Royal Hospital for Women, Sydney, New South Wales, Australia.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Michalowski', 'Affiliation': 'Department of Newborn Care, Royal Hospital for Women, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kylie-Ann', 'Initials': 'KA', 'LastName': 'Mallitt', 'Affiliation': ""School of Women's and Children's Health, University of New South Wales, Sydney, New South Wales, Australia.""}, {'ForeName': 'Abhijeet', 'Initials': 'A', 'LastName': 'Singla', 'Affiliation': 'Department of Newborn Care, Royal Hospital for Women, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Lui', 'Affiliation': 'Department of Newborn Care, Royal Hospital for Women, Sydney, New South Wales, Australia.'}]",Neonatology,['10.1159/000515415'] 3477,33845449,Economic Viability and Efficacy of Day Case Versus Inpatient Tonsillectomy in Southern Iran.,"OBJECTIVES Day case tonsillectomy compared with inpatient tonsillectomy has increasingly become a trend for many patients undergoing elective surgeries. Unjustified stays of tonsillectomy can be avoided by day case surgery, which consequently reduces treatment costs. The aim of this study was therefore to determine the cost and effectiveness of day case tonsillectomy compared with inpatient tonsillectomy. METHODS This cost-effectiveness study was performed on 300 patients from May 2017 to April 2018. Patients were randomly divided into 2 groups: day case (n = 150) and inpatient (n = 150). Consequences used in model included incidence of bleeding, blood transfusion, and reoperation frequency within 2 weeks after surgery and also the patients' pain during 24 hours after surgery. Costs were collected from societal perspective, so the costs included direct medical and nonmedical costs as well as indirect costs. One-way sensitivity analysis was conducted to measure the uncertainty effects of the parameters. The collected data were analyzed using software TreeAge and Excel 2016. RESULTS Day case tonsillectomy was more cost-effective than inpatient. Mean total costs in day case and inpatient were $915.1 and $1227.9, respectively. Besides, the mean effectiveness was 0.921 and 0.914 percent, respectively. Also, 1-way sensitivity analysis proved the robustness of the results of study. CONCLUSIONS Day case tonsillectomy is a cost-effective strategy and can be suggested as a good alternative for a wide range of patients after tonsillectomy. Supporting day case surgery for tonsillectomy cases can significantly reduce the financial burden.",2021,"Mean total costs in day case and inpatient were $915.1 and $1227.9, respectively.","['Southern Iran', 'patients undergoing elective surgeries', '300 patients from May 2017 to April 2018']","['inpatient tonsillectomy', 'day case tonsillectomy']","['Economic Viability and Efficacy of Day Case', 'Mean total costs', 'cost and effectiveness', 'mean effectiveness', 'incidence of bleeding, blood transfusion, and reoperation frequency', 'cost-effective']","[{'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",300.0,0.0232011,"Mean total costs in day case and inpatient were $915.1 and $1227.9, respectively.","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Faramarzi', 'Affiliation': 'Otolaryngology Research Center, Department of Otorhinolaryngology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Fardid', 'Affiliation': 'Center for Health Related Social and Behavioral Sciences Research, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Kaboodkhani', 'Affiliation': 'School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mehrnoosh', 'Initials': 'M', 'LastName': 'Emadi', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Shahmohammadi', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Khosro', 'Initials': 'K', 'LastName': 'Keshavarz', 'Affiliation': 'Health Human Resources Research Center, School of Management and Medical Informatics, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: khkeshavarz@sums.ac.ir.'}]",Value in health regional issues,['10.1016/j.vhri.2020.10.007'] 3478,33845345,Engaging stakeholders in the refinement of an evidence-based remotely delivered epilepsy self-management program for rural populations.,"A growing body of research supports self-management approaches that can improve outcomes in people living with epilepsy (PLWE). An evidence-based remotely delivered self-management program (SMART) that was successfully delivered in an urban/suburban setting has the potential to be particularly helpful to PLWE who live in rural communities, where heavy stigma burden and limited access to healthcare is common. In this Phase 1 exploratory study, focus groups of key rural stakeholders (PLWE, family members, care providers) were used to: (1) gather information on factors that may impede or facilitate participation in SMART and (2) elicit overall perceptions of the program, as well as suggestions and feedback for refining it for implementation in Phase 2 of the randomized controlled study (RCT). Qualitative data analysis revealed that focus group participants identified geographic and social isolation, and the more limited access to epilepsy care, as the major barriers to epilepsy self-management for rural populations. However, they felt strongly that SMART could fill an epilepsy care gap in rural communities, and provided suggestions for recruitment and retention strategies of subjects, as well as improvement/modifications to the program curriculum for the Phase 2 RCT.",2021,"An evidence-based remotely delivered self-management program (SMART) that was successfully delivered in an urban/suburban setting has the potential to be particularly helpful to PLWE who live in rural communities, where heavy stigma burden and limited access to healthcare is common.","['rural populations', 'people living with epilepsy (PLWE', 'focus groups of key rural stakeholders (PLWE, family members, care providers']",['SMART'],[],"[{'cui': 'C0035962', 'cui_str': 'Rural Population'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}]","[{'cui': 'C0235048', 'cui_str': 'Smarting pain'}]",[],,0.0111372,"An evidence-based remotely delivered self-management program (SMART) that was successfully delivered in an urban/suburban setting has the potential to be particularly helpful to PLWE who live in rural communities, where heavy stigma burden and limited access to healthcare is common.","[{'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Blixen', 'Affiliation': 'Department of Psychiatry and Neurological and Behavioral Outcomes Center, Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center, Cleveland, OH, USA. Electronic address: cxb28@case.edu.'}, {'ForeName': 'Gena', 'Initials': 'G', 'LastName': 'Ghearing', 'Affiliation': 'Department of Neurology, University of Iowa Health Care, Iowa City, IA, USA.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Wade', 'Affiliation': 'Department of Neurology, University of Iowa Health Care, Iowa City, IA, USA.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Colon-Zimmerman', 'Affiliation': 'Department of Psychiatry and Neurological and Behavioral Outcomes Center, Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Maegan', 'Initials': 'M', 'LastName': 'Tyrrell', 'Affiliation': 'Department of Neurology, University of Iowa Health Care, Iowa City, IA, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Sajatovic', 'Affiliation': 'Department of Psychiatry and Neurological and Behavioral Outcomes Center, Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center, Cleveland, OH, USA; Department of Psychiatry & Neurology and Neurological and Behavioral Outcomes Center, Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center, Cleveland, OH, USA.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2021.107942'] 3479,33844958,Comparison of Laparoscopic and Open Surgery in the Treatment of Renal Hydatid Cysts.,"Background: To compare the efficacy, safety, and long-term results of laparoscopic and open approaches in patients undergoing surgery for renal hydatid cyst. Materials and Methods: The files of 36 patients who were surgically treated in our clinic and with diagnosis of renal cyst hydatid confirmed pathologically were reviewed. According to the surgical technique applied, the patients were divided into two groups as open (group 1) or laparoscopic (group 2) partial pericystectomy. Oral albendazole was given 10 mg/kg/day (in two divided doses) for 4 weeks preoperatively and for three cycles of 4 weeks at 1-week intervals after surgery in all patients. Demographic characteristics, laboratory and imaging findings, operation times, hospitalization times, complications, intraoperative bleeding amounts, and recurrence rates were statistically compared in both groups. Results: Open partial pericystectomy was performed in 21 patients in group 1, and laparoscopic transperitoneal partial pericystectomy was performed in 15 patients in group 2. Operation time and intraoperative bleeding amount in group 1 and group 2 were 119.6 ± 17.1/116.1 ± 17.6 minutes and 125.7 ± 27.8/113.9 ± 19.2 mL, respectively. There was no statistically significant difference between these values ( P  = .557, P  = .167, respectively). Hospitalization duration of both groups was 5.9 ± 1.4/3.6 ± 0.7 days, respectively. Hospitalization duration in group 2 was statistically significantly shorter ( P  < .001). No recurrence occurred during postoperative follow-up in either group. Conclusions: In the treatment of renal hydatid cysts, laparoscopy, which is a minimally invasive approach, can be technically applied with the same principles as open surgery and has a similar efficacy and safety profile for short- and long-term results.",2021,"There was no statistically significant difference between these values ( P  = .557, P  = .167, respectively).","['Renal Hydatid Cysts', 'patients undergoing surgery for renal hydatid cyst', '36 patients who were surgically treated in our clinic and with diagnosis of renal cyst hydatid confirmed pathologically were reviewed']","['laparoscopic (group 2) partial pericystectomy', 'laparoscopic transperitoneal partial pericystectomy', 'Laparoscopic and Open Surgery', 'laparoscopic and open approaches', 'Oral albendazole']","['recurrence', 'Hospitalization duration', 'Operation time and intraoperative bleeding', 'efficacy, safety', 'Demographic characteristics, laboratory and imaging findings, operation times, hospitalization times, complications, intraoperative bleeding amounts, and recurrence rates']","[{'cui': 'C0341683', 'cui_str': 'Hydatid cyst of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0268800', 'cui_str': 'Simple renal cyst'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0282443', 'cui_str': 'Review'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0205501', 'cui_str': 'Transperitoneal approach'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001911', 'cui_str': 'Albendazole'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}]",36.0,0.0194948,"There was no statistically significant difference between these values ( P  = .557, P  = .167, respectively).","[{'ForeName': 'Ediz', 'Initials': 'E', 'LastName': 'Vuruskan', 'Affiliation': 'Department of Urology, Health Sciences University, Adana City Training and Research Hospital, Adana, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Ercil', 'Affiliation': 'Department of Urology, Health Sciences University, Adana City Training and Research Hospital, Adana, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Anil', 'Affiliation': 'Department of Urology, Health Sciences University, Adana City Training and Research Hospital, Adana, Turkey.'}, {'ForeName': 'Umut', 'Initials': 'U', 'LastName': 'Unal', 'Affiliation': 'Department of Urology, Adana Seyhan State Hospital, Adana, Turkey.'}, {'ForeName': 'Ferhat', 'Initials': 'F', 'LastName': 'Ortoglu', 'Affiliation': 'Department of Urology, Health Sciences University, Adana City Training and Research Hospital, Adana, Turkey.'}, {'ForeName': 'Kadir', 'Initials': 'K', 'LastName': 'Karkin', 'Affiliation': 'Department of Urology, Health Sciences University, Adana City Training and Research Hospital, Adana, Turkey.'}, {'ForeName': 'Lokman', 'Initials': 'L', 'LastName': 'Ayhan', 'Affiliation': 'Department of Urology, Health Sciences University, Adana City Training and Research Hospital, Adana, Turkey.'}, {'ForeName': 'Zafer Gokhan', 'Initials': 'ZG', 'LastName': 'Gurbuz', 'Affiliation': 'Department of Urology, Health Sciences University, Adana City Training and Research Hospital, Adana, Turkey.'}]",Journal of laparoendoscopic & advanced surgical techniques. Part A,['10.1089/lap.2021.0031'] 3480,33844901,"A pilot randomized controlled trial of dialectical behavior therapy (DBT) for reducing craving and achieving cessation in patients with marijuana use disorder: feasibility, acceptability, and appropriateness.","OBJECTIVE To conduct a pilot RCT investigating the feasibility, acceptability, and preliminary efficacy of dialectical behavioral therapy (DBT) for marijuana cessation and craving reduction. METHODS Sixty-one patients with marijuana use disorder diagnoses were randomly assigned to a DBT group or a control group (psycho-education). Patients completed measures at pre-intervention, postintervention, and at two-month follow-up. The Marijuana Craving Questionnaire (MCQ) and marijuana urine test kits were used to assess craving and abstinence respectively. RESULTS The feasibility of DBT was significantly higher than control group feasibility. In the DBT 29/30 participants completed all sessions (96% retention) and 24/31 control group participants completed all sessions (77% retention) (χ2 = 4.95, p = 0.02). Moreover, 29/30 (96%) participants in the DBT group completed the two-month follow-up and 20/31 (64.5%) control group members completed the two-month follow-up (χ2 = 9.97, p = 0.002). The results showed that patients in the DBT group had significantly higher intervention acceptability rates (16.57 vs. 9.6) than those in the control group. This pattern was repeated for appropriateness rates (p < 0.05). The overall results for craving showed that there was no significant difference between the groups (F = 3.52, p > 0.05), although DBT showed a significant reduction in the ""emotionality"" subscale compared to the control group (F = 19.94, p < 0.05). To analyze cessation rates, DBT was compared to the control group at the posttest (46% vs. 16%) and follow-up (40% vs. 9.5%) and the results confirmed higher effectiveness in the DBT group for cessation (p < 0.05). Furthermore, among those who had lapsed, participants in the DBT group had fewer consumption days than those in the control group (p < 0.05). CONCLUSIONS DBT showed feasibility, acceptability, and promising efficacy in terms of the marijuana cessation rate. CLINICAL TRIAL REGISTRATION Thailand Registry of Clinical Trials, TCTR20200319007.",2021,The results showed that patients in the DBT group had significantly higher intervention acceptability rates (16.57 vs. 9.6) than those in the control group.,"['Sixty-one patients with marijuana use disorder diagnoses', 'patients with marijuana use disorder']","['dialectical behavioral therapy (DBT', 'control group (psycho-education', 'dialectical behavior therapy (DBT', 'DBT']","['cessation rates, DBT', 'feasibility, acceptability', 'intervention acceptability rates', 'Marijuana Craving Questionnaire (MCQ) and marijuana urine test kits', 'emotionality"" subscale', 'feasibility of DBT']","[{'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024810', 'cui_str': 'Marihuana Smoking'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C1321145', 'cui_str': 'Dialectical behavior therapy'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0542317', 'cui_str': 'Character trait finding of affective stability'}]",61.0,0.0673879,The results showed that patients in the DBT group had significantly higher intervention acceptability rates (16.57 vs. 9.6) than those in the control group.,"[{'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Davoudi', 'Affiliation': 'Department of Clinical Psychology, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Allame', 'Affiliation': 'Department of Clinical Psychology, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Aliakbar', 'Initials': 'A', 'LastName': 'Foroughi', 'Affiliation': 'Department of Clinical Psychology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Amir Abbas', 'Initials': 'AA', 'LastName': 'Taheri', 'Affiliation': 'Department of Clinical Psychology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}]",Trends in psychiatry and psychotherapy,['10.47626/2237-6089-2020-0123'] 3481,33844890,Effects of using montelukast during acute wheezing attack in hospitalized preschool children on the discharge rate and the clinical asthma score.,"BACKGROUND In chronic asthma treatment, leukotriene receptor antagonists have been recommended, but it is not clear whether montelukast can be used in acute recurrent wheezing attacks in children. OBJECTIVE To investigate the safety and effectiveness of oral montelukast in addition to standard treatment in hospitalized children aged between 6 and 72 months with acute recurrent wheezing attacks. METHOD One hundred patients aged between 6 and 72 months who had wheezing attacks with clinical asthma scores (CAS) ≥3 and were hospitalized were included in this randomized, double-blind, placebo-controlled, parallel-group clinical trial. All the patients included in the study were given 0.15 mg/kg (maximum 5 mg) nebulized salbutamol (8 L/min and with 100% O 2 ) with 4 h of intervals, 1 mg/kg prednisolone (maximum 5 days), nebulized ipratropium bromide (total eight doses) with 6 h of intervals. In addition to this treatment, one group received 4 mg montelukast, and the other group received a placebo. The CAS of the patients were evaluated with 4-h intervals. RESULTS Total hospital length of stay (LOS) was not different between the montelukast and placebo groups (p = 0.981). There was no statistically significant difference between the two treatment groups in terms of discharge time, CAS, and oxygen saturation (p ≥ 0.05). CONCLUSION Adding montelukast to standard treatment in patients hospitalized for moderate-to-severe wheezing attacks did not affect hospital LOS and CAS.",2021,"There was no statistically significant difference between the two treatment groups in terms of discharge time, CAS, and oxygen saturation (p ≥ 0.05). ","['patients hospitalized for moderate-to-severe wheezing attacks', 'hospitalized preschool children', 'hospitalized children aged between 6 and 72 months with acute recurrent wheezing attacks', 'acute recurrent wheezing attacks in children', 'One hundred patients aged between 6 and 72 months who had wheezing attacks with clinical asthma scores (CAS) ≥3 and were hospitalized']","['nebulized salbutamol', '4\u2009mg montelukast', 'oral montelukast', 'montelukast', 'placebo', 'prednisolone (maximum 5 days), nebulized ipratropium bromide']","['discharge rate and the clinical asthma score', 'Total hospital length of stay (LOS', 'discharge time, CAS, and oxygen saturation', 'safety and effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0298130', 'cui_str': 'montelukast'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0700580', 'cui_str': 'ipratropium bromide'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",100.0,0.216158,"There was no statistically significant difference between the two treatment groups in terms of discharge time, CAS, and oxygen saturation (p ≥ 0.05). ","[{'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Demet Akbaş', 'Affiliation': ""Department of Pediatric Endocrinology, Dörtçelik Children's Hospital, Bursa, Turkey.""}, {'ForeName': 'Cem H', 'Initials': 'CH', 'LastName': 'Razi', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Atilim University, Ankara, Turkey.'}, {'ForeName': 'Nesibe', 'Initials': 'N', 'LastName': 'Andıran', 'Affiliation': 'Department of Pediatric Endocrinology, Güven Hospital, Ankara, Turkey.'}]",Pediatric pulmonology,['10.1002/ppul.25394'] 3482,33844651,Potential reversal of epigenetic age using a diet and lifestyle intervention: a pilot randomized clinical trial.,"Manipulations to slow biological aging and extend healthspan are of interest given the societal and healthcare costs of our aging population. Herein we report on a randomized controlled clinical trial conducted among 43 healthy adult males between the ages of 50-72. The 8-week treatment program included diet, sleep, exercise and relaxation guidance, and supplemental probiotics and phytonutrients. The control group received no intervention. Genome-wide DNA methylation analysis was conducted on saliva samples using the Illumina Methylation Epic Array and DNAmAge was calculated using the online Horvath DNAmAge clock (2013). The diet and lifestyle treatment was associated with a 3.23 years decrease in DNAmAge compared with controls (p=0.018). DNAmAge of those in the treatment group decreased by an average 1.96 years by the end of the program compared to the same individuals at the beginning with a strong trend towards significance (p=0.066). Changes in blood biomarkers were significant for mean serum 5-methyltetrahydrofolate (+15%, p=0.004) and mean triglycerides (-25%, p=0.009). To our knowledge, this is the first randomized controlled study to suggest that specific diet and lifestyle interventions may reverse Horvath DNAmAge (2013) epigenetic aging in healthy adult males. Larger-scale and longer duration clinical trials are needed to confirm these findings, as well as investigation in other human populations.",2021,Changes in blood biomarkers were significant for mean serum 5-methyltetrahydrofolate,"['healthy adult males', '43 healthy adult males between the ages of 50-72']","['diet and lifestyle intervention', 'specific diet and lifestyle interventions', 'no intervention', '5-methyltetrahydrofolate', 'diet, sleep, exercise and relaxation guidance, and supplemental probiotics and phytonutrients']","['mean triglycerides', 'blood biomarkers']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0049315', 'cui_str': '5-methyltetrahydrofolate'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0577749', 'cui_str': 'Phytochemical'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",43.0,0.0198497,Changes in blood biomarkers were significant for mean serum 5-methyltetrahydrofolate,"[{'ForeName': 'Kara N', 'Initials': 'KN', 'LastName': 'Fitzgerald', 'Affiliation': 'Institute for Functional Medicine, Federal Way, WA 98003, USA.'}, {'ForeName': 'Romilly', 'Initials': 'R', 'LastName': 'Hodges', 'Affiliation': 'American Nutrition Association, Hinsdale, IL 60521, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Hanes', 'Affiliation': 'Helfgott Research Institute, National University of Natural Medicine, Portland, OR 97201, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Stack', 'Affiliation': 'Helfgott Research Institute, National University of Natural Medicine, Portland, OR 97201, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cheishvili', 'Affiliation': 'HKG Epitherapeutics (Hong Kong), Department of Molecular Biology, Ariel University, Israel, Gerald Bronfman Department of Oncology, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Szyf', 'Affiliation': 'Department of Pharmacology and Therapeutics, McGill University, Montreal, QC H3G 1Y6, Canada.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Henkel', 'Affiliation': 'Helfgott Research Institute, National University of Natural Medicine, Portland, OR 97201, USA.'}, {'ForeName': 'Melissa W', 'Initials': 'MW', 'LastName': 'Twedt', 'Affiliation': 'Helfgott Research Institute, National University of Natural Medicine, Portland, OR 97201, USA.'}, {'ForeName': 'Despina', 'Initials': 'D', 'LastName': 'Giannopoulou', 'Affiliation': 'Helfgott Research Institute, National University of Natural Medicine, Portland, OR 97201, USA.'}, {'ForeName': 'Josette', 'Initials': 'J', 'LastName': 'Herdell', 'Affiliation': 'Helfgott Research Institute, National University of Natural Medicine, Portland, OR 97201, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Logan', 'Affiliation': 'Helfgott Research Institute, National University of Natural Medicine, Portland, OR 97201, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Bradley', 'Affiliation': 'Helfgott Research Institute, National University of Natural Medicine, Portland, OR 97201, USA.'}]",Aging,['10.18632/aging.202913'] 3483,33844642,Lactoferrin for the treatment of age-associated inflammation - A pilot study.,"Background Chronic inflammation (CI) is a common trait of aging associated with adverse outcomes including mortality. We hypothesized that recombinant human Lactoferrin (rhLf) would reduce chronic inflammation of aging. Methods Thirty-six community dwelling older adults were randomly assigned to rhLf or placebo treatment in 1:1 ratio for 3 months. IL-6, sTNFR1, Comprehensive Metabolic Panel (CMP), and Complete Blood Count (CBC) were measured at baseline, 1 month, 3 months, and 6 months. Physical and cognitive measures were completed at same timepoints, including 4-m walking speed (m/s), grip strength (kg), 6-min walking distance (m), home activity measured by accelerometer, trail making test - Part A (s) and - Part B (s), and Digit symbol substitution test (number correctly coded). Primary outcomes were differences in IL-6 and sTNFR1 concentrations evaluated by generalized linear model with log-link and gamma family distribution, controlling for baseline cytokine concentrations. Results rhLF was well-tolerated. There were a significant number of abdominal complaints and increased drop-out rate in placebo group. Participants in rhLf arm had non-significant lower mean percent increase in IL6 at 3 months (rhLf mean IL-6 6% lower than control, P = 0.843), and sTNFaR1 (rhLf mean 2% lower than control, P = 0.36). No significant changes were observed for the cognitive or physical measures. Conclusion Treatment with rhLf did not significantly alter serum IL6 or sTNFR1 concentrations of older adults. This study may have been underpowered to detect difference, but provided evidence that a larger sample-size could more definitively determine the effect of rhLF on age-associated CI.",2021,"Participants in rhLf arm had non-significant lower mean percent increase in IL6 at 3 months (rhLf mean IL-6 6% lower than control, P = 0.843), and sTNFaR1 (rhLf mean 2% lower than control, P = 0.36).","['older adults', 'Methods\n\n\nThirty-six community dwelling older adults']","['Lactoferrin', 'rhLf or placebo', 'placebo', 'recombinant human Lactoferrin (rhLf']","['serum IL6 or sTNFR1 concentrations', 'IL6', 'tolerated', '4-m walking speed (m/s), grip strength (kg), 6-min walking distance (m), home activity measured by accelerometer, trail making test - Part A (s) and - Part B (s), and Digit symbol substitution test (number correctly coded', 'abdominal complaints', 'cognitive or physical measures', 'Physical and cognitive measures', 'IL-6 and sTNFR1 concentrations evaluated by generalized linear model with log-link and gamma family distribution, controlling for baseline cytokine concentrations', 'sTNFaR1', 'IL-6, sTNFR1, Comprehensive Metabolic Panel (CMP), and Complete Blood Count (CBC']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0023732', 'cui_str': 'Models, Linear'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0009555', 'cui_str': 'Complete blood count'}]",36.0,0.188016,"Participants in rhLf arm had non-significant lower mean percent increase in IL6 at 3 months (rhLf mean IL-6 6% lower than control, P = 0.843), and sTNFaR1 (rhLf mean 2% lower than control, P = 0.36).","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Laskow', 'Affiliation': 'Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Langdon', 'Affiliation': 'Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Abadir', 'Affiliation': 'Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Q-L', 'Initials': 'QL', 'LastName': 'Xue', 'Affiliation': 'Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Walston', 'Affiliation': 'Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}]",Physiology international,['10.1556/2060.2021.00010'] 3484,33844623,"Immunogenicity and safety of a nine-valent human papillomavirus vaccine in Vietnamese males and females (9 to 26 years of age): an open-label, phase 3 trial.","This open-label, single-center, Phase 3 study (NCT03546842) assessed the immunogenicity and safety of the nine-valent human papillomavirus (9vHPV; HPV6/11/16/18/31/33/45/52/58) vaccine in Vietnamese males and females, with the aim to support 9vHPV vaccine licensure in Vietnam. Participants aged 9-26 years received three 9vHPV vaccine doses (Day 1, Month 2, Month 6). Serum samples were obtained on Day 1 (pre-vaccination) and at Month 7 (one month post-Dose 3) for the measurement of anti-HPV antibodies. Geometric mean titers (GMTs) and seroconversion percentages were obtained using the HPV-9 competitive Luminex immunoassay. Injection-site adverse events (AEs), systemic AEs, serious AEs (SAEs), and study discontinuations due to AEs were recorded. Of 201 participants enrolled, 200 (99.5%) received ≥1 vaccine dose. All participants who received the three-dose regimen (198/200, 98.5%) seroconverted for all 9vHPV vaccine types by Month 7. Robust anti-HPV GMT responses were also observed. Half of participants (50.5%) reported ≥1 AE; the majority were injection-site-related (45.0%) and mild (43.0%). There were no deaths, vaccine-related SAEs, or discontinuations due to AEs. Administration of three 9vHPV vaccine doses was highly immunogenic and resulted in acceptable seropositivity percentages for all vaccine HPV types. The 9vHPV vaccine was generally well tolerated among this study population. Region of origin : Vietnam Trial registration : clinicaltrials.gov Identifier NCT03546842.",2021,Administration of three 9vHPV vaccine doses was highly immunogenic and resulted in acceptable seropositivity percentages for all vaccine HPV types.,"['201 participants enrolled, 200 (99.5%) received ≥1 vaccine dose', 'Vietnamese males and females (9 to 26 years of age', 'Participants aged 9-26\xa0years', 'Vietnamese males and females']","['9vHPV vaccine', 'nine-valent human papillomavirus (9vHPV; HPV6/11/16/18/31/33/45/52/58) vaccine', 'nine-valent human papillomavirus vaccine']","['Injection-site adverse events (AEs), systemic AEs, serious AEs (SAEs), and study discontinuations due to AEs', 'immunogenicity and safety', 'Robust anti-HPV GMT responses', 'acceptable seropositivity percentages', 'Immunogenicity and safety', 'Geometric mean titers (GMTs) and seroconversion percentages']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4517912', 'cui_str': '99.5'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}]","[{'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}]",201.0,0.290643,Administration of three 9vHPV vaccine doses was highly immunogenic and resulted in acceptable seropositivity percentages for all vaccine HPV types.,"[{'ForeName': 'Vu Dinh', 'Initials': 'VD', 'LastName': 'Thiem', 'Affiliation': 'National Institute of Hygiene and Epidemiology, Hanoi, Vietnam.'}, {'ForeName': 'Nguyen Dang', 'Initials': 'ND', 'LastName': 'Quang', 'Affiliation': 'National Institute of Hygiene and Epidemiology, Hanoi, Vietnam.'}, {'ForeName': 'Nguyen Hai', 'Initials': 'NH', 'LastName': 'Tuan', 'Affiliation': 'National Institute of Hygiene and Epidemiology, Hanoi, Vietnam.'}, {'ForeName': 'Kyeongmi', 'Initials': 'K', 'LastName': 'Cheon', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Gallagher', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Luxembourg', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Group', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Badshah', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2020.1865739'] 3485,33844622,A double-blind study of empathic support and expectation as mechanisms of symptom change.,"Objective : A novel brief intervention was used to investigate how empathic support and expectation can induce changes in mood, anxiety, and perceived stress. Method : Seventy-six undergraduates with high negative affect were assigned to three conditions of a program involving tasks with no known therapeutic benefit. In Group 1: Expectation Only, participants were given a deceptive description of the benefits of the program to quantify the magnitude of symptom change due to expectation alone. In Group 2: Empathic Support + Expectation, participants were also instructed to write about past and current sources of distress and provided with supportive notes each week to quantify the role of empathic support plus expectation. In Group 3: Control, participants were told they were ""norming"" the instruments. Results : Participants in Groups 1 and 2 demonstrated decreases in depression, anxiety, and rumination, with significant medium effect reductions found in the empathic support plus expectation condition. Conclusions : Evidence suggests that empathic support and expectation cause reduction of symptoms spanning depression and anxiety.",2021,"Participants in Groups 1 and 2 demonstrated decreases in depression, anxiety, and rumination, with significant medium effect reductions found in the empathic support plus expectation condition. ",['Method : Seventy-six undergraduates with high negative affect'],[],"['depression, anxiety, and rumination', 'empathic support plus expectation condition', 'mood, anxiety, and perceived stress']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",[],"[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",76.0,0.0671845,"Participants in Groups 1 and 2 demonstrated decreases in depression, anxiety, and rumination, with significant medium effect reductions found in the empathic support plus expectation condition. ","[{'ForeName': 'Joel G', 'Initials': 'JG', 'LastName': 'Thomas', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Sharp', 'Affiliation': 'Max Planck UCL Centre for Computational Psychiatry and Ageing Research, University College London, London, UK.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Niznikiewicz', 'Affiliation': 'Hines Veterans Administration, Chicago, IL, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Heller', 'Affiliation': 'Department of Psychology, University of Illinois at Urbana-Champaign, Champaign, IL, USA.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2021.1909770'] 3486,33845941,Microdiscectomy compared with transforaminal epidural steroid injection for persistent radicular pain caused by prolapsed intervertebral disc: the NERVES RCT.,"BACKGROUND Sciatica is a common condition reported to affect > 3% of the UK population at any time and is most often caused by a prolapsed intervertebral disc. Currently, there is no uniformly adopted treatment strategy. Invasive treatments, such as surgery (i.e. microdiscectomy) and transforaminal epidural steroid injection, are often reserved for failed conservative treatment. OBJECTIVE To compare the clinical effectiveness and cost-effectiveness of microdiscectomy with transforaminal epidural steroid injection for the management of radicular pain secondary to lumbar prolapsed intervertebral disc for non-emergency presentation of sciatica of < 12 months' duration. INTERVENTIONS Patients were randomised to either (1) microdiscectomy or (2) transforaminal epidural steroid injection. DESIGN A pragmatic, multicentre, randomised prospective trial comparing microdiscectomy with transforaminal epidural steroid injection for sciatica due to prolapsed intervertebral disc with < 1 year symptom duration. SETTING NHS services providing secondary spinal surgical care within the UK. PARTICIPANTS A total of 163 participants (aged 16-65 years) were recruited from 11 UK NHS outpatient clinics. MAIN OUTCOME MEASURES The primary outcome was participant-completed Oswestry Disability Questionnaire score at 18 weeks post randomisation. Secondary outcomes were visual analogue scores for leg pain and back pain; modified Roland-Morris score (for sciatica), Core Outcome Measures Index score and participant satisfaction at 12-weekly intervals. Cost-effectiveness and quality of life were assessed using the EuroQol-5 Dimensions, five-level version; Hospital Episode Statistics data; medication usage; and self-reported cost data at 12-weekly intervals. Adverse event data were collected. The economic outcome was incremental cost per quality-adjusted life-year gained from the perspective of the NHS in England. RESULTS Eighty-three participants were allocated to transforaminal epidural steroid injection and 80 participants were allocated to microdiscectomy, using an online randomisation system. At week 18, Oswestry Disability Questionnaire scores had decreased, relative to baseline, by 26.7 points in the microdiscectomy group and by 24.5 points in the transforaminal epidural steroid injection. The difference between the treatments was not statistically significant (estimated treatment effect -4.25 points, 95% confidence interval -11.09 to 2.59 points). Nor were there significant differences between treatments in any of the secondary outcomes: Oswestry Disability Questionnaire scores, visual analogue scores for leg pain and back pain, modified Roland-Morris score and Core Outcome Measures Index score up to 54 weeks. There were four (3.8%) serious adverse events in the microdiscectomy group, including one nerve palsy (foot drop), and none in the transforaminal epidural steroid injection group. Compared with transforaminal epidural steroid injection, microdiscectomy had an incremental cost-effectiveness ratio of £38,737 per quality-adjusted life-year gained and a probability of 0.17 of being cost-effective at a willingness to pay threshold of £20,000 per quality-adjusted life-year. LIMITATIONS Primary outcome data was invalid or incomplete for 24% of participants. Sensitivity analyses demonstrated robustness to assumptions made regarding missing data. Eighteen per cent of participants in the transforaminal epidural steroid injection group subsequently received microdiscectomy prior to their primary outcome assessment. CONCLUSIONS To the best of our knowledge, the NErve Root Block VErsus Surgery trial is the first trial to evaluate the comparative clinical effectiveness and cost-effectiveness of microdiscectomy and transforaminal epidural steroid injection. No statistically significant difference was found between the two treatments for the primary outcome. It is unlikely that microdiscectomy is cost-effective compared with transforaminal epidural steroid injection at a threshold of £20,000 per quality-adjusted life-year for sciatica secondary to prolapsed intervertebral disc. FUTURE WORK These results will lead to further studies in the streamlining and earlier management of discogenic sciatica. TRIAL REGISTRATION Current Controlled Trials ISRCTN04820368 and EudraCT 2014-002751-25. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 25, No. 24. See the NIHR Journals Library website for further project information.",2021,"The difference between the treatments was not statistically significant (estimated treatment effect -4.25 points, 95% confidence interval -11.09 to 2.59 points).","['Eighty-three participants', 'sciatica due to prolapsed intervertebral disc with <\u20091 year symptom duration', 'NHS services providing secondary spinal surgical care within the UK', 'A total of 163 participants (aged 16-65 years) were recruited from 11 UK NHS outpatient clinics', ""radicular pain secondary to lumbar prolapsed intervertebral disc for non-emergency presentation of sciatica of <\u200912 months' duration""]","['transforaminal epidural steroid injection', 'microdiscectomy', 'microdiscectomy or (2) transforaminal epidural steroid injection', 'Microdiscectomy', 'microdiscectomy with transforaminal epidural steroid injection', 'microdiscectomy and transforaminal epidural steroid injection']","['visual analogue scores for leg pain and back pain; modified Roland-Morris score (for sciatica), Core Outcome Measures Index score and participant satisfaction at 12-weekly intervals', 'incremental cost-effectiveness ratio', 'participant-completed Oswestry Disability Questionnaire score', 'Oswestry Disability Questionnaire scores', 'Oswestry Disability Questionnaire scores, visual analogue scores for leg pain and back pain, modified Roland-Morris score and Core Outcome Measures Index score', 'serious adverse events', 'Cost-effectiveness and quality of life']","[{'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0036396', 'cui_str': 'Sciatica'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0242362', 'cui_str': 'Intervertebral disc prolapse'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0278147', 'cui_str': 'Radicular pain'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]","[{'cui': 'C0196394', 'cui_str': 'Epidural steroid injection'}, {'cui': 'C0457629', 'cui_str': 'Lumbar microdiscectomy'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0036396', 'cui_str': 'Sciatica'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",83.0,0.182142,"The difference between the treatments was not statistically significant (estimated treatment effect -4.25 points, 95% confidence interval -11.09 to 2.59 points).","[{'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Wilby', 'Affiliation': 'Department of Neurosurgery, The Walton Centre NHS Foundation Trust (member of Liverpool Health Partners), Liverpool, UK.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Best', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool (member of Liverpool Health Partners), Liverpool, UK.'}, {'ForeName': 'Eifiona', 'Initials': 'E', 'LastName': 'Wood', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.'}, {'ForeName': 'Girvan', 'Initials': 'G', 'LastName': 'Burnside', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool (member of Liverpool Health Partners), Liverpool, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Bedson', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool (member of Liverpool Health Partners), Liverpool, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Short', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool (member of Liverpool Health Partners), Liverpool, UK.'}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'Wheatley', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool (member of Liverpool Health Partners), Liverpool, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hill-McManus', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.'}, {'ForeName': 'Manohar', 'Initials': 'M', 'LastName': 'Sharma', 'Affiliation': 'Department of Pain Medicine, The Walton Centre NHS Foundation Trust, Liverpool, Liverpool, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Clark', 'Affiliation': 'Department of Neurosurgery, The Walton Centre NHS Foundation Trust (member of Liverpool Health Partners), Liverpool, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Bostock', 'Affiliation': 'Patient and public involvement representative, Kent, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Hay', 'Affiliation': 'Patient and public involvement representative, Norfolk, UK.'}, {'ForeName': 'Ganesan', 'Initials': 'G', 'LastName': 'Baranidharan', 'Affiliation': 'Leeds Teaching Hospital NHS Trust, Leeds General Infirmary, Leeds, UK.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Price', 'Affiliation': 'Pain Clinic, Solent NHS Trust, Southampton, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Mannion', 'Affiliation': 'Cambridge University Hospitals NHS Trust, Cambridge, UK.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Hutchinson', 'Affiliation': 'Academic Division of Neurosurgery, University of Cambridge, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Dyfrig A', 'Initials': 'DA', 'LastName': 'Hughes', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Marson', 'Affiliation': 'Department of Pharmacology and Therapeutics, University of Liverpool and The Walton Centre NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Paula R', 'Initials': 'PR', 'LastName': 'Williamson', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool (member of Liverpool Health Partners), Liverpool, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta25240'] 3487,33845888,"Prophylactic use of dural tenting sutures in elective craniotomies in adults-is it necessary? A study protocol for a multicentre, investigator- and participant-blinded randomised, parallel-group, non-inferiority trial.","BACKGROUND In the early days of neurosurgery, extradural haemorrhages (EDHs) contributed to a high mortality rate after craniotomies. Almost a century ago, Walter Dandy reported dural tenting sutures as an effective way to prevent postoperative EDH. Over time, his technique gained in popularity and significance to finally become a neurosurgical standard. Yet, several retrospective reports and one prospective report have questioned the ongoing need for dural tenting sutures. Dandy's explanation that the haemostasis observed under hypotensive conditions is deceiving and eventually causes EDH may be obsolete. Today, proper intra- and postoperative care, including maintenance of normovolemia and normotension and the use of modern haemostatic agents, may be sufficient for effective haemostasis. Thus, there is a fundamental need to evaluate the necessity of dural tenting sutures in a solid, unbiased, evidence-based manner. METHODS This study is designed as a randomised, multicentre, double-blinded, controlled interventional trial with 1:1 allocation. About one half of the participants will undergo craniotomy without dural tenting sutures and will be considered an intervention group. The other half will undergo craniotomy with these sutures. Both groups will be followed clinically and radiologically. The primary outcome is reoperation due to extradural haematoma. Secondary outcomes aim to evaluate the impact of dural tenting sutures on mortality, readmission risk, postoperative headaches, size of extradural collection, cerebrospinal fluid leak risk and the presence of any new neurological deficit. The study protocol follows the SPIRIT 2013 statement. DISCUSSION It is possible that many neurosurgeons around the globe are tenting the dura in elective craniotomies which brings no benefit and only extends the operation. Unfortunately, there is not enough data to support or reject this technique in modern neurosurgery. This is the first study that may produce strong, evidence-based recommendations on using dural tenting sutures. TRIAL REGISTRATION, ETHICS AND DISSEMINATION The Bioethics Committee of the Medical University of Warsaw approved the study protocol (KB/106/2018). The trial is registered at http://www.clinicaltrials.gov ( NCT03658941 ) on September 6, 2018. The findings of this trial will be submitted to a peer-reviewed neurosurgical journal. Abstracts will be submitted to relevant national and international conferences. TRIAL STATUS Protocol version and date: version 1.5, 14.01.2020 First recruitment: September 7, 2018 Estimated recruitment completion: September 1, 2021.",2021,It is possible that many neurosurgeons around the globe are tenting the dura in elective craniotomies which brings no benefit and only extends the operation.,"['Protocol version and date: version 1.5, 14.01.2020 First recruitment: September 7, 2018 Estimated recruitment completion: September 1, 2021']",['dural tenting sutures'],"['mortality, readmission risk, postoperative headaches, size of extradural collection, cerebrospinal fluid leak risk and the presence of any new neurological deficit', 'reoperation due to extradural haematoma']","[{'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0237322', 'cui_str': 'Decreased skin turgor'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0023182', 'cui_str': 'Cerebrospinal fluid leak'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0238154', 'cui_str': 'Epidural hemorrhage'}]",,0.364665,It is possible that many neurosurgeons around the globe are tenting the dura in elective craniotomies which brings no benefit and only extends the operation.,"[{'ForeName': 'Przemysław', 'Initials': 'P', 'LastName': 'Kunert', 'Affiliation': 'Department of Neurosurgery, Medical University of Warsaw, Banacha St. 1a, 02-097, Warsaw, Poland.'}, {'ForeName': 'Łukasz', 'Initials': 'Ł', 'LastName': 'Przepiórka', 'Affiliation': 'Department of Neurosurgery, Medical University of Warsaw, Banacha St. 1a, 02-097, Warsaw, Poland. lukasz.przepiorka@wum.edu.pl.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Fortuniak', 'Affiliation': 'Department of Neurosurgery and Oncology of Central Nervous System, Barlicki University Hospital, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Karol', 'Initials': 'K', 'LastName': 'Wiśniewski', 'Affiliation': 'Department of Neurosurgery and Oncology of Central Nervous System, Barlicki University Hospital, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Ernest Jan', 'Initials': 'EJ', 'LastName': 'Bobeff', 'Affiliation': 'Department of Neurosurgery and Oncology of Central Nervous System, Barlicki University Hospital, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Patrycja', 'Initials': 'P', 'LastName': 'Larysz', 'Affiliation': 'Department of Neurosurgery, Medical University of Silesia, Regional Hospital, Sosnowiec, Poland.'}, {'ForeName': 'Rafał', 'Initials': 'R', 'LastName': 'Kruk', 'Affiliation': 'Neurosurgery and Pediatric Neurosurgery Department in Lublin, Medical University of Lublin, Lublin, Poland.'}, {'ForeName': 'Bartłomiej', 'Initials': 'B', 'LastName': 'Kulesza', 'Affiliation': 'Neurosurgery and Pediatric Neurosurgery Department in Lublin, Medical University of Lublin, Lublin, Poland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Szczepanek', 'Affiliation': 'Neurosurgery and Pediatric Neurosurgery Department in Lublin, Medical University of Lublin, Lublin, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ładziński', 'Affiliation': 'Department of Neurosurgery, Medical University of Silesia, Regional Hospital, Sosnowiec, Poland.'}, {'ForeName': 'Jarosław', 'Initials': 'J', 'LastName': 'Żyłkowski', 'Affiliation': 'Second Department of Radiology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Sławomir', 'Initials': 'S', 'LastName': 'Kujawski', 'Affiliation': 'Department of Hygiene, Epidemiology and Ergonomics, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Toruń, Toruń, Poland.'}, {'ForeName': 'Kamila', 'Initials': 'K', 'LastName': 'Łabędzka', 'Affiliation': 'Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Jaskólski', 'Affiliation': 'Department of Neurosurgery and Oncology of Central Nervous System, Barlicki University Hospital, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Radosław', 'Initials': 'R', 'LastName': 'Rola', 'Affiliation': 'Neurosurgery and Pediatric Neurosurgery Department in Lublin, Medical University of Lublin, Lublin, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Trojanowski', 'Affiliation': 'Neurosurgery and Pediatric Neurosurgery Department in Lublin, Medical University of Lublin, Lublin, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Marchel', 'Affiliation': 'Department of Neurosurgery, Medical University of Warsaw, Banacha St. 1a, 02-097, Warsaw, Poland.'}]",Trials,['10.1186/s13063-021-05201-z'] 3488,33845881,The efficacy of N-Acetylcysteine in severe COVID-19 patients: A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES Severe acute respiratory infection (SARI) caused by the SARS-CoV-2 virus may cause lung failure and the need for mechanical ventilation. Infection with SARS-COV-2 can lead to activation of inflammatory factors, increased reactive oxygen species, and cell damage. In addition to mucolytic effects, N-Acetylcysteine has antioxidant effects that we believe can help patients recover. In this study, we evaluate the efficacy of N-Acetylcysteine in patients with severe COVID-19. TRIAL DESIGN This is a prospective, randomized, single-blinded, phase 3 controlled clinical trial with two arms (ratio 1:1) parallel-group design of 40 patients, using the placebo in the control group. PARTICIPANTS All severe COVID-19 patients with at least one of the following five conditions: (respiration rate > 30 per minute), hypoxemia (O2 ≤ saturation, arterial oxygen partial pressure ratio <300), pulmonary infiltration (> 50% of lung area during 24 48 h), Lactate dehydrogenase (LDH) > 245 U / l, Progressive lymphopenia, and admitted to the intensive care unit of Shahid Mohammadi Hospital in Bandar Abbas and have positive PCR test results for SARS-Cov-2 and sign the written consent of the study will be included. Patients will be excluded from the study if they have a history of hypersensitivity to N-Acetylcysteine, pregnancy, or refuse to participate in the study. INTERVENTION AND COMPARATOR After randomization, participants in the intervention group receive standard of care (SOC) according to the National Committee of COVID-19 plus N-acetylcysteine (EXI-NACE 200mg/mL, in 10mL ampules of saline for parenteral injection (EXIR pharmaceutical company)) at a dose of 300 mg/kg equivalent to 20 gr as a slow single intravenous injection on the first day of hospitalization. In the control group patients receive SOC and placebo ( Sterile water for injection as the same dose). The placebo is identical in appearance to the N-acetylcysteine injection (EXIR pharmaceutical company as well). MAIN OUTCOMES The primary endpoint for this study is a composite endpoint for the length of hospitalization in the intensive care unit and the patient's clinical condition. These outcomes were measured at the baseline (before the intervention) and on the 14th day after the intervention or on the discharge day. RANDOMISATION Eligible participants (40) will be randomized in two arms in the ratio of 1: 1 (20 per arm) using online web-based tools and by permuted block randomization method. To ensure randomization concealment, random sequence codes are assigned to patients by the treatment team at the time of admission without knowing that each code is in the intervention or comparator group. BLINDING (MASKING) All participants will be informed about participating in the study and the possible side effects of medication and placebo. Patients participating in the study will not be aware of the assignment to the intervention or control group. The principal investigator, health care personnel, data collectors, and those evaluating the outcome are aware of patient grouping. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) A total of 40 patients participate in this study, which are randomly divided; 20 patients in the intervention group will receive SOC and N-acetylcysteine, 20 patients in the control group will receive SOC and placebo. TRIAL STATUS First version of the protocol was approved by the Deputy of Research and Technology and the ethics committee of Hormozgan University of Medical Sciences on February 14, 2021, with the local code 990573, and the recruitment started on March 2, 2021 and the expected recruitment end date is April 1, 2021. TRIAL REGISTRATION The protocol was registered before starting participant recruitment entitled: Evaluation of the efficacy of N-Acetylcysteine in severe COVID-19 patients: a randomized controlled phase III clinical trial, IRCT20200509047364N3 , at Iranian Registry of clinical trials on 20 February 2021. FULL PROTOCOL The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).",2021,"The protocol was registered before starting participant recruitment entitled: Evaluation of the efficacy of N-Acetylcysteine in severe COVID-19 patients: a randomized controlled phase III clinical trial, IRCT20200509047364N3 , at Iranian Registry of clinical trials on 20 February 2021. ","['Patients participating in the study will not be aware of the assignment to the intervention or control group', 'in severe COVID-19 patients', 'Patients will be excluded from the study if they have a history of hypersensitivity to N-Acetylcysteine, pregnancy, or refuse to participate in the study', '40 patients', 'severe COVID-19 patients', 'All severe COVID-19 patients with at least one of the following five conditions: (respiration rate > 30 per minute), hypoxemia (O2 ≤ saturation, arterial oxygen partial pressure ratio <300), pulmonary infiltration (> 50% of lung area during 24 48 h), Lactate dehydrogenase (LDH', '40 patients participate in this study, which are randomly divided; 20 patients in the', 'patients with severe COVID-19']","['intervention group will receive SOC and N-acetylcysteine', 'SOC and placebo', 'standard of care (SOC) according to the National Committee of COVID-19 plus N-acetylcysteine (EXI-NACE 200mg/mL, in 10mL ampules of saline', 'placebo', 'N-Acetylcysteine']","[""length of hospitalization in the intensive care unit and the patient's clinical condition""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1136454', 'cui_str': 'Refusal to Participate'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0235896', 'cui_str': 'Lung infiltration'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0332849', 'cui_str': 'Divide'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0179031', 'cui_str': 'Ampule'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",40.0,0.462054,"The protocol was registered before starting participant recruitment entitled: Evaluation of the efficacy of N-Acetylcysteine in severe COVID-19 patients: a randomized controlled phase III clinical trial, IRCT20200509047364N3 , at Iranian Registry of clinical trials on 20 February 2021. ","[{'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Rahimi', 'Affiliation': 'Clinical Research Development Center, Shahid Mohammadi Hospital, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Samimagham', 'Affiliation': 'Clinical Research Development Center, Shahid Mohammadi Hospital, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mehdi Hassani', 'Initials': 'MH', 'LastName': 'Azad', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Dariush', 'Initials': 'D', 'LastName': 'Hooshyar', 'Affiliation': 'Student Research Committee, Faculty of Medicine, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Arabi', 'Affiliation': 'Department of Internal Medicine and Public Health Research Center, Family Medicine Department, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'KazemiJahromi', 'Affiliation': 'Endocrinology and Metabolism Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran. mitra.kazemijahromi@gmail.com.'}]",Trials,['10.1186/s13063-021-05242-4'] 3489,33845867,Multi-arm Trial of Inflammatory Signal Inhibitors (MATIS) for hospitalised patients with mild or moderate COVID-19 pneumonia: a structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES The primary objective of MATIS is to determine the efficacy of ruxolitinib (RUX) or fostamatinib (FOS) compared to standard of care (SOC) with respect to reducing the proportion of hospitalised patients progressing from mild or moderate to severe COVID-19 pneumonia. Secondary objectives, at 14 and 28 days, are to: Determine the efficacy of RUX or FOS to reduce mortality Determine the efficacy of RUX or FOS to reduce the need for invasive ventilation or ECMO Determine the efficacy of RUX or FOS to reduce the need for non-invasive ventilation Determine the efficacy of RUX or FOS to reduce the proportion of participants suffering significant oxygen desaturation Determine the efficacy of RUX or FOS to reduce the need for renal replacement therapy Determine the efficacy of RUX and FOS to reduce the incidence of venous thromboembolism Determine the efficacy of RUX and FOS to reduce the severity of COVID-19 pneumonia [graded by a 9-point modified WHO Ordinal Scale* Determine the efficacy of RUX or FOS to reduce systemic inflammation Determine the efficacy of RUX or FOS to the incidence of renal impairment Determine the efficacy of RUX or FOS to reduce duration of hospital stay Evaluate the safety of RUX and FOS for treatment of COVID-19 pneumonia. TRIAL DESIGN A multi-arm, multi-stage (3-arm parallel-group, 2-stage) randomised controlled trial that allocates participants 1:1:1 and tests for superiority in experimental arms versus standard of care. PARTICIPANTS Patients will be recruited while inpatients during hospitalisation for COVID-19 in multiple centres throughout the UK including Imperial College Healthcare NHS Trust. INCLUSION Patients age ≥ 18 years at screening Patients with mild or moderate COVID-19 pneumonia, defined as Grade 3 or 4 severity by the WHO COVID-19 Ordinal Scale Patients meeting criteria: Hospitalization AND SARS-CoV2 infection (clinically suspected or laboratory confirmed) AND Radiological change consistent with COVID-19 disease CRP ≥ 30mg/L at any time point Informed consent from patient or personal or professional representative Agreement to abstain from sexual intercourse or use contraception that is >99% effective for all participants of childbearing potential for 42 days after the last dose of study drug. For male participants, agreement to abstain from sperm donation for 42 days after the last dose of study drug. EXCLUSION Requiring either invasive or non-invasive ventilation including CPAP or high flow nasal oxygen at any point after hospital admission but before baseline, not related to a pre-existing condition (e.g., obstructive sleep apnoea) Grade ≥ 5 severity on the modified WHO COVID-19 Ordinal Scale, i.e. SpO 2 < 90% on ≥ 60% inspired oxygen by facemask at baseline; non-invasive ventilation; or invasive mechanical ventilation In the opinion of the investigator, progression to death is inevitable within the next 24 hours, irrespective of the provision of therapy Known severe allergic reactions to the investigational agents Child-Pugh B or C grade hepatic dysfunction Use of drugs within the preceding 14 days that are known to interact with any study treatment (FOS or RUX), as listed in the Summary of Product Characteristics Pregnant or breastfeeding Any medical condition or concomitant medication that in the opinion of the investigator would compromise subjects' safety or compliance with study procedures. Any medical condition which in the opinion of the principal investigator would compromise the scientific integrity of the study Non-English speakers will be able to join the study. If participants are unable to understand verbal or written information in English, then hospital translation services will be requested at the participating site for the participant where possible. INTERVENTION AND COMPARATOR RUXOLITINIB (RUX) (14 days): An oral selective and potent inhibitor of Janus Associated Kinases (JAK1 and JAK2) and cell proliferation (Verstovek, 2010). It is approved for the treatment of disease-related splenomegaly or constitutional symptoms in myelofibrosis, polycythaemia vera and graft-versus-host-disease. RUX will be administered orally 10mg bd Day 1-7 and 5mg bd Day 8-14. FOSTAMATINIB (FOS) (14 days): An oral spleen tyrosine kinase inhibitor approved for the treatment of thrombocytopenia in adult participants with chronic immune thrombocytopenia. FOS will be administered orally 150mg bd Day 1-7 and 100mg bd Day 8-14. Please see protocol for recommended dose modifications where required. COMPARATOR (Standard of Care, SOC): experimental arms will be compared to participants receiving standard of care. It is accepted that SOC may change during a rapidly evolving pandemic. Co-enrolment to other trials and rescue therapy, either pre- or post-randomisation, is permitted and will be accounted for in the statistical analysis. MAIN OUTCOMES Pairwise comparison (RUX vs SOC and FOS vs SOC) of the proportion of participants diagnosed with severe COVID-19 pneumonia within 14 days. Severe COVID-19 pneumonia is defined by a score ≥ 5 on a modified WHO COVID-19 Ordinal Scale, comprising the following indicators of disease severity: Death OR Requirement for invasive ventilation OR Requirement for non-invasive ventilation including CPAP or high flow oxygen OR O 2 saturation < 90% on ≥60% inspired oxygen RANDOMISATION: Participants will be allocated to interventions using a central web-based randomisation service that generates random sequences using random permuted blocks (1:1:1), with stratification by age (<65 and ≥65 years) and site. BLINDING (MASKING) No participants or caregivers are blinded to group assignment. Clinical outcomes will be compared blind to group assignment. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) For an early informal dose examination by the Data Monitoring Committee a minimum of 30 participants will be recruited. For Stage 1 of this multi-arm multi-stage study, 171 participants will be randomised, with 57 participants in each arm. If at least one experimental intervention shows promise, then Stage 2 will recruit a further 95 participants per arm. Sample size calculations are given in the protocol. TRIAL STATUS Recruitment is ongoing and started 2 nd October 2020. We anticipate completion of Stage 1 by July 2021 and Stage 2 by April 2022. The current protocol version 2.0 of 11 th February 2021 is appended. TRIAL REGISTRATION EudraCT: 2020-001750-22 , 9 th July 2020 ClinicalTrials.gov: NCT04581954 , 9 th October 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2021,Determine the efficacy of RUX or FOS to reduce duration of hospital,"['hospitalised patients progressing from mild or moderate to severe COVID-19 pneumonia', 'participants receiving standard of care', '171 participants will be randomised, with 57 participants in each arm', '2020-001750-22 , 9 th July 2020', 'hospitalised patients with mild or moderate COVID-19 pneumonia', 'adult participants with chronic immune thrombocytopenia', 'Patients will be recruited while inpatients during hospitalisation for COVID-19 in multiple centres throughout the UK including Imperial College Healthcare NHS Trust', '30 participants will be recruited']","['Inflammatory Signal Inhibitors (MATIS', 'RUX', 'RUX or FOS', 'ruxolitinib (RUX) or fostamatinib (FOS', 'FOS', 'invasive mechanical ventilation', 'RUX and FOS']","['obstructive sleep apnoea', 'Severe COVID-19 pneumonia', 'duration of hospital', 'severity of COVID-19 pneumonia', 'renal impairment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0242584', 'cui_str': 'Autoimmune thrombocytopenia'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0237935', 'cui_str': 'Trust'}]","[{'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2931926', 'cui_str': 'ruxolitinib'}, {'cui': 'C2713632', 'cui_str': 'fostamatinib'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}]","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}]",171.0,0.334759,Determine the efficacy of RUX or FOS to reduce duration of hospital,"[{'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Vergis', 'Affiliation': 'Imperial College, London and Imperial NHS Trust, London, UK. nvergis@ic.ac.uk.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Phillips', 'Affiliation': 'Imperial Clinical Trials Unit and Imperial College, London, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Cornelius', 'Affiliation': 'Imperial Clinical Trials Unit and Imperial College, London, UK.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Katsarou', 'Affiliation': 'Imperial College, London and Imperial NHS Trust, London, UK.'}, {'ForeName': 'Taryn', 'Initials': 'T', 'LastName': 'Youngstein', 'Affiliation': 'Imperial College, London and Imperial NHS Trust, London, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Cook', 'Affiliation': 'Imperial College, London and Imperial NHS Trust, London, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Willicombe', 'Affiliation': 'Imperial College, London and Imperial NHS Trust, London, UK.'}, {'ForeName': 'Clio', 'Initials': 'C', 'LastName': 'Pilay', 'Affiliation': 'Imperial College, London and Imperial NHS Trust, London, UK.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Shturova', 'Affiliation': 'Imperial College, London and Imperial NHS Trust, London, UK.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Almonte', 'Affiliation': 'Imperial College, London and Imperial NHS Trust, London, UK.'}, {'ForeName': 'Asad', 'Initials': 'A', 'LastName': 'Charania', 'Affiliation': 'Imperial College, London and Imperial NHS Trust, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Turner', 'Affiliation': 'Imperial College, London and Imperial NHS Trust, London, UK.'}, {'ForeName': 'Onn Min', 'Initials': 'OM', 'LastName': 'Kon', 'Affiliation': 'Imperial College, London and Imperial NHS Trust, London, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Cooke', 'Affiliation': 'Imperial College, London and Imperial NHS Trust, London, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Thursz', 'Affiliation': 'Imperial College, London and Imperial NHS Trust, London, UK.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Cherlin', 'Affiliation': 'Newcastle Clinical Trials Unit and Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wason', 'Affiliation': 'Newcastle Clinical Trials Unit and Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Dragana', 'Initials': 'D', 'LastName': 'Milojkovic', 'Affiliation': 'Imperial College, London and Imperial NHS Trust, London, UK.'}, {'ForeName': 'Andew J', 'Initials': 'AJ', 'LastName': 'Innes', 'Affiliation': 'Imperial College, London and Imperial NHS Trust, London, UK.'}, {'ForeName': 'Nichola', 'Initials': 'N', 'LastName': 'Cooper', 'Affiliation': 'Imperial College, London and Imperial NHS Trust, London, UK.'}]",Trials,['10.1186/s13063-021-05190-z'] 3490,33845035,"Intraoperative irradiation for early breast cancer (ELIOT): long-term recurrence and survival outcomes from a single-centre, randomised, phase 3 equivalence trial.","BACKGROUND In the randomised, phase 3 equivalence trial on electron intraoperative radiotherapy (ELIOT), accelerated partial breast irradiation (APBI) with the use of intraoperative radiotherapy was associated with a higher rate of ipsilateral breast tumour recurrence (IBTR) than whole-breast irradiation (WBI) in patients with early-stage breast cancer. Here, we aimed to examine the planned long-term recurrence and survival outcomes from the ELIOT trial. METHODS This single-centre, randomised, phase 3 equivalence trial was done at the European Institute of Oncology (Milan, Italy). Eligible women, aged 48-75 years with a clinical diagnosis of a unicentric breast carcinoma with an ultrasound diameter not exceeding 25 mm, clinically negative axillary lymph nodes, and who were suitable for breast-conserving surgery, were randomly assigned (1:1) via a web-based system, with a random permuted block design (block size of 16) and stratified by clinical tumour size, to receive post-operative WBI with conventional fractionation (50 Gy given as 25 fractions of 2 Gy, plus a 10 Gy boost), or 21 Gy intraoperative radiotherapy with electrons (ELIOT) in a single dose to the tumour bed during surgery. The trial was open label and no-one was masked to treatment group assignment. The primary endpoint was the occurrence of IBTR. The trial was designed assuming a 5-year IBTR rate of 3% in the WBI group and equivalence of the two groups, if the 5-year IBTR rate in the ELIOT group did not exceed a 2·5 times excess, corresponding to 7·5%. Overall survival was the secondary endpoint. The main analysis was done by intention to treat. The cumulative incidence of IBTR events and overall survival were assessed at 5, 10, and 15 years of follow-up. This trial is registered with ClinicalTrials.gov, NCT01849133. FINDINGS Between Nov 20, 2000, and Dec 27, 2007, 1305 women were enrolled and randomly assigned: 654 to the WBI group and 651 to the ELIOT group. After a median follow-up of 12·4 years (IQR 9·7-14·7), 86 (7%) patients developed IBTR, with 70 (11%) cases in the ELIOT group and 16 (2%) in the WBI group, corresponding to an absolute excess of 54 IBTRs in the ELIOT group (HR 4·62, 95% CI 2·68-7·95, p<0·0001). In the ELIOT group, the 5-year IBTR rate was 4·2% (95% CI 2·8-5·9), the 10-year rate was 8·1% (6·1-10·3), and the 15-year rate was 12·6% (9·8-15·9). In the WBI group, the 5-year IBTR rate was 0·5% (95% CI 0·1-1·3), the 10-year rate was 1·1% (0·5-2·2), and the 15-year rate was 2·4% (1·4-4·0). At final follow-up on March 11, 2019, 193 (15%) women had died from any cause, with no difference between the two groups (98 deaths in the ELIOT group vs 95 in the WBI group; HR 1·03, 95% CI 0·77-1·36, p=0·85). In the ELIOT group, the overall survival rate was 96·8% (95% CI 95·1-97·9) at 5 years, 90·7% (88·2-92·7) at 10 years, and 83·4% (79·7-86·4) at 15 years; and in the WBI group, the overall survival rate was 96·8% (95·1-97·9) at 5 years, 92·7% (90·4-94·4) at 10 years, and 82·4% (78·5-85·6) at 15 years. We did not collect long-term data on adverse events. INTERPRETATION The long-term results of this trial confirmed the higher rate of IBTR in the ELIOT group than in the WBI group, without any differences in overall survival. ELIOT should be offered to selected patients at low-risk of IBTR. FUNDING Italian Association for Cancer Research, Jacqueline Seroussi Memorial Foundation for Cancer Research, Umberto Veronesi Foundation, American Italian Cancer Foundation, The Lombardy Region, and Italian Ministry of Health.",2021,"In the ELIOT group, the overall survival rate was 96·8% (95% CI 95·1-97·9) at 5 years, 90·7% (88·2-92·7) at 10 years, and 83·4% (79·7-86·4) at 15 years; and in the WBI group, the overall survival rate was 96·8% (95·1-97·9) at 5 years, 92·7% (90·4-94·4) at 10 years, and 82·4% (78·5-85·6) at 15 years.","['Between Nov 20, 2000, and Dec 27, 2007, 1305 women were enrolled and randomly assigned: 654 to the WBI group and 651 to the ELIOT group', 'Eligible women, aged 48-75 years with a clinical diagnosis of a unicentric breast carcinoma with an ultrasound diameter not exceeding 25 mm, clinically negative axillary lymph nodes, and who were suitable for breast-conserving surgery', 'patients with early-stage breast cancer', 'early breast cancer (ELIOT']","['intraoperative radiotherapy', 'whole-breast irradiation (WBI', 'electron intraoperative radiotherapy (ELIOT), accelerated partial breast irradiation (APBI', 'Intraoperative irradiation', 'conventional fractionation (50 Gy given as 25 fractions of 2 Gy, plus a 10 Gy boost), or 21 Gy intraoperative radiotherapy with electrons (ELIOT']","['rate of ipsilateral breast tumour recurrence (IBTR', '15-year rate', 'cumulative incidence of IBTR events and overall survival', 'overall survival rate', 'occurrence of IBTR', '10-year rate', 'Overall survival', '5-year IBTR rate', 'IBTR', 'rate of IBTR', 'overall survival']","[{'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013852', 'cui_str': 'Electron'}, {'cui': 'C0338240', 'cui_str': 'Intraoperative radiation therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C4518564', 'cui_str': 'Unicentric'}, {'cui': 'C0678222', 'cui_str': 'Carcinoma of breast'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0729594', 'cui_str': 'Axillary lymph node group'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0338240', 'cui_str': 'Intraoperative radiation therapy'}, {'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0013852', 'cui_str': 'Electron'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C3896696', 'cui_str': 'Accelerated partial breast irradiation'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0524811', 'cui_str': 'Dose Fractionation, Radiotherapy'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}]","[{'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C1458155', 'cui_str': 'Neoplasm of breast'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",1305.0,0.501318,"In the ELIOT group, the overall survival rate was 96·8% (95% CI 95·1-97·9) at 5 years, 90·7% (88·2-92·7) at 10 years, and 83·4% (79·7-86·4) at 15 years; and in the WBI group, the overall survival rate was 96·8% (95·1-97·9) at 5 years, 92·7% (90·4-94·4) at 10 years, and 82·4% (78·5-85·6) at 15 years.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Orecchia', 'Affiliation': 'Scientific Directorate, IEO European Institute of Oncology IRCCS, Milan, Italy. Electronic address: roberto.orecchia@ieo.it.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Veronesi', 'Affiliation': 'Scientific Directorate, IEO European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Maisonneuve', 'Affiliation': 'Division of Epidemiology and Biostatistics, IEO European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Viviana Enrica', 'Initials': 'VE', 'LastName': 'Galimberti', 'Affiliation': 'Division of Breast Surgery, IEO European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Lazzari', 'Affiliation': 'Division of Radiation Oncology, IEO European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Veronesi', 'Affiliation': 'Division of Breast Surgery, IEO European Institute of Oncology IRCCS, Milan, Italy; Department of Oncology and Haemato-Oncology, University of Milan, Milan, Italy.'}, {'ForeName': 'Barbara Alicja', 'Initials': 'BA', 'LastName': 'Jereczek-Fossa', 'Affiliation': 'Division of Radiation Oncology, IEO European Institute of Oncology IRCCS, Milan, Italy; Department of Oncology and Haemato-Oncology, University of Milan, Milan, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Cattani', 'Affiliation': 'Unit of Medical Physics, IEO European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Sangalli', 'Affiliation': 'Data Management, IEO European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Luini', 'Affiliation': 'Division of Breast Surgery, IEO European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Caldarella', 'Affiliation': 'Division of Breast Surgery, IEO European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Venturino', 'Affiliation': 'Division of Anaesthesiology, IEO European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Sances', 'Affiliation': 'Division of Anaesthesiology, IEO European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Zurrida', 'Affiliation': 'Division of Breast Surgery, IEO European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Viale', 'Affiliation': 'Division of Pathology, IEO European Institute of Oncology IRCCS, Milan, Italy; Department of Oncology and Haemato-Oncology, University of Milan, Milan, Italy.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Leonardi', 'Affiliation': 'Division of Radiation Oncology, IEO European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Mattia', 'Initials': 'M', 'LastName': 'Intra', 'Affiliation': 'Division of Breast Surgery, IEO European Institute of Oncology IRCCS, Milan, Italy.'}]",The Lancet. Oncology,['10.1016/S1470-2045(21)00080-2'] 3491,33844996,"Inhaled budesonide in the treatment of early COVID-19 (STOIC): a phase 2, open-label, randomised controlled trial.","BACKGROUND Multiple early reports of patients admitted to hospital with COVID-19 showed that patients with chronic respiratory disease were significantly under-represented in these cohorts. We hypothesised that the widespread use of inhaled glucocorticoids among these patients was responsible for this finding, and tested if inhaled glucocorticoids would be an effective treatment for early COVID-19. METHODS We performed an open-label, parallel-group, phase 2, randomised controlled trial (Steroids in COVID-19; STOIC) of inhaled budesonide, compared with usual care, in adults within 7 days of the onset of mild COVID-19 symptoms. The trial was done in the community in Oxfordshire, UK. Participants were randomly assigned to inhaled budsonide or usual care stratified for age (≤40 years or >40 years), sex (male or female), and number of comorbidities (≤1 and ≥2). Randomisation was done using random sequence generation in block randomisation in a 1:1 ratio. Budesonide dry powder was delivered using a turbohaler at a dose of 800 μg per actuation. Participants were asked to take two inhalations twice a day until symptom resolution. The primary endpoint was COVID-19-related urgent care visit, including emergency department assessment or hospitalisation, analysed for both the per-protocol and intention-to-treat (ITT) populations. The secondary outcomes were self-reported clinical recovery (symptom resolution), viral symptoms measured using the Common Cold Questionnare (CCQ) and the InFLUenza Patient Reported Outcome Questionnaire (FLUPro), body temperature, blood oxygen saturations, and SARS-CoV-2 viral load. The trial was stopped early after independent statistical review concluded that study outcome would not change with further participant enrolment. This trial is registered with ClinicalTrials.gov, NCT04416399. FINDINGS From July 16 to Dec 9, 2020, 167 participants were recruited and assessed for eligibility. 21 did not meet eligibility criteria and were excluded. 146 participants were randomly assigned-73 to usual care and 73 to budesonide. For the per-protocol population (n=139), the primary outcome occurred in ten (14%) of 70 participants in the budesonide group and one (1%) of 69 participant in the usual care group (difference in proportions 0·131, 95% CI 0·043 to 0·218; p=0·004). For the ITT population, the primary outcome occurred in 11 (15%) participants in the usual care group and two (3%) participants in the budesonide group (difference in proportions 0·123, 95% CI 0·033 to 0·213; p=0·009). The number needed to treat with inhaled budesonide to reduce COVID-19 deterioration was eight. Clinical recovery was 1 day shorter in the budesonide group compared with the usual care group (median 7 days [95% CI 6 to 9] in the budesonide group vs 8 days [7 to 11] in the usual care group; log-rank test p=0·007). The mean proportion of days with a fever in the first 14 days was lower in the budesonide group (2%, SD 6) than the usual care group (8%, SD 18; Wilcoxon test p=0·051) and the proportion of participants with at least 1 day of fever was lower in the budesonide group when compared with the usual care group. As-needed antipyretic medication was required for fewer proportion of days in the budesonide group compared with the usual care group (27% [IQR 0-50] vs 50% [15-71]; p=0·025) Fewer participants randomly assigned to budesonide had persistent symptoms at days 14 and 28 compared with participants receiving usual care (difference in proportions 0·204, 95% CI 0·075 to 0·334; p=0·003). The mean total score change in the CCQ and FLUPro over 14 days was significantly better in the budesonide group compared with the usual care group (CCQ mean difference -0·12, 95% CI -0·21 to -0·02 [p=0·016]; FLUPro mean difference -0·10, 95% CI -0·21 to -0·00 [p=0·044]). Blood oxygen saturations and SARS-CoV-2 load, measured by cycle threshold, were not different between the groups. Budesonide was safe, with only five (7%) participants reporting self-limiting adverse events. INTERPRETATION Early administration of inhaled budesonide reduced the likelihood of needing urgent medical care and reduced time to recovery after early COVID-19. FUNDING National Institute for Health Research Biomedical Research Centre and AstraZeneca.",2021,Fewer participants randomly assigned to budesonide had persistent symptoms at days 14 and 28 compared with participants receiving usual care (difference in proportions,"['From July 16 to Dec 9, 2020, 167 participants were recruited and assessed for eligibility', 'for age (≤40 years or >40 years), sex (male or female), and number of comorbidities (≤1 and ≥2', 'adults within 7 days of the onset of mild COVID-19 symptoms', '146 participants were randomly assigned-73 to usual care and 73 to']","['Inhaled budesonide', 'Budesonide dry powder', 'budesonide', 'inhaled budsonide or usual care stratified', 'inhaled budesonide', 'Budesonide']","['chronic respiratory disease', 'Blood oxygen saturations and SARS-CoV-2 load', 'mean proportion of days with a fever', 'self-reported clinical recovery (symptom resolution), viral symptoms measured using the Common Cold Questionnare (CCQ) and the InFLUenza Patient Reported Outcome Questionnaire (FLUPro), body temperature, blood oxygen saturations, and SARS-CoV-2 viral load', 'mean total score change', 'persistent symptoms', 'likelihood of needing urgent medical care', 'COVID-19-related urgent care visit, including emergency department assessment or hospitalisation, analysed for both the per-protocol and intention-to-treat (ITT) populations', 'fever', 'Clinical recovery']","[{'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}]","[{'cui': 'C0264220', 'cui_str': 'Chronic disease of respiratory system'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009443', 'cui_str': 'Common cold'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C2362545', 'cui_str': 'Urgent Care'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",146.0,0.275822,Fewer participants randomly assigned to budesonide had persistent symptoms at days 14 and 28 compared with participants receiving usual care (difference in proportions,"[{'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Ramakrishnan', 'Affiliation': 'Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK; National Institute for Health Research (NIHR), Oxford Biomedical Research Centre, Oxford, UK; School of Medical and Health Sciences, Edith Cowan University, Perth, WA, Australia.'}, {'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Nicolau', 'Affiliation': 'Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK; UQ Centre for Clinical Research, The University of Queensland, Brisbane, QLD, Australia; School of Mathematical Sciences, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Langford', 'Affiliation': 'Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK; National Institute for Health Research (NIHR), Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Mahdi', 'Affiliation': 'Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK; National Institute for Health Research (NIHR), Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Jeffers', 'Affiliation': 'Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK; National Institute for Health Research (NIHR), Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Mwasuku', 'Affiliation': 'Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK; National Institute for Health Research (NIHR), Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Krassowska', 'Affiliation': 'Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK; National Institute for Health Research (NIHR), Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Fox', 'Affiliation': 'Bicester Health Centre, Bicester, UK; NIHR, Thames Valley and South Midlands, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Binnian', 'Affiliation': 'Eynsham Medical Group, Eynsham, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Glover', 'Affiliation': 'White Horse Medical Practice, Faringdon, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bright', 'Affiliation': 'Windrush Medical Practice, Witney, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Butler', 'Affiliation': 'Nuffield Department of Primary Health Care Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Cane', 'Affiliation': 'Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK; National Institute for Health Research (NIHR), Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Halner', 'Affiliation': 'Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Philippa C', 'Initials': 'PC', 'LastName': 'Matthews', 'Affiliation': 'Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK; Department of Infectious Diseases and Microbiology, Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Oxford, UK.'}, {'ForeName': 'Louise E', 'Initials': 'LE', 'LastName': 'Donnelly', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, UK.'}, {'ForeName': 'Jodie L', 'Initials': 'JL', 'LastName': 'Simpson', 'Affiliation': 'Priority Research Centre for Healthy Lungs, School of Medicine and Public Health, University of Newcastle, NSW, Australia.'}, {'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Baker', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, UK.'}, {'ForeName': 'Nabil T', 'Initials': 'NT', 'LastName': 'Fadai', 'Affiliation': 'School of Mathematical Sciences, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Peterson', 'Affiliation': 'STATMIND, Lund, Sweden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bengtsson', 'Affiliation': 'STATMIND, Lund, Sweden.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Barnes', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, UK.'}, {'ForeName': 'Richard E K', 'Initials': 'REK', 'LastName': 'Russell', 'Affiliation': 'Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK; National Institute for Health Research (NIHR), Oxford Biomedical Research Centre, Oxford, UK; Southernhealth NHS Foundation Trust, Hampshire, UK.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Bafadhel', 'Affiliation': 'Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK; National Institute for Health Research (NIHR), Oxford Biomedical Research Centre, Oxford, UK. Electronic address: mona.bafadhel@ndm.ox.ac.uk.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(21)00160-0'] 3492,33841955,Effect of OM-85 BV on reducing bronchiectasis exacerbation in Chinese patients: the iPROBE study.,"Background Bronchiectasis is characterized by recurrent infectious exacerbations. No existing data inform preventive strategy for exacerbations beyond chronic macrolides. OM-85 BV, an immunostimulant, has been shown to prevent recurrent respiratory infections. We initiated this 1-year, multi-centered, double-blind, and controlled trial to investigate the PReventive effect of OM-85 BV on Bronchiectasis Exacerbations in Chinese patients (iPROBE). Methods Patients with bronchiectasis aged 18 to 75 years, having at least one exacerbation in the past year, were randomized to receive, in addition to any respiratory medications, two courses of 7 mg of OM-85 BV or matching placebo (one capsule orally per day for 10 days a month) for 3 consecutive months, followed by 3 months without treatment. The primary outcomes included the number of acute infectious exacerbations and the time to first exacerbation. Secondary endpoints included patient-reported respiratory outcomes. Safety measures were also assessed. Results Among the 196 participants, 99 were in the OM-85 BV group and 97 in the placebo group. At week 52, the mean number of acute exacerbations per patient was equal to 0.98 and 0.75, respectively, in the two groups (P=0.14). Difference in the time to first pulmonary exacerbation was not statistically significant (P=0.11). There was no statistically significant difference in any secondary end-points. The safety profile in the two arms was good and the majority of adverse events were mild. Conclusions OM-85 BV did not demonstrate protection in decreasing pulmonary exacerbations of bronchiectasis in this trial performed in Chinese patients. It had good safety profile.",2021,Difference in the time to first pulmonary exacerbation was not statistically significant (P=0.11).,"['Chinese patients (iPROBE', '196 participants, 99 were in the OM-85 BV group and 97 in the placebo group', 'Patients with bronchiectasis aged 18 to 75 years, having at least one exacerbation in the past year', 'Chinese patients']","['OM-85 BV', 'OM-85 BV or matching placebo']","['safety profile', 'time to first pulmonary exacerbation', 'Bronchiectasis Exacerbations', 'number of acute infectious exacerbations and the time to first exacerbation', 'bronchiectasis exacerbation', 'patient-reported respiratory outcomes', 'mean number of acute exacerbations', 'pulmonary exacerbations of bronchiectasis']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0163642', 'cui_str': 'OM-85 BV'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006267', 'cui_str': 'Bronchiectasis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1444637', 'cui_str': 'Past'}]","[{'cui': 'C0163642', 'cui_str': 'OM-85 BV'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0006267', 'cui_str': 'Bronchiectasis'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",196.0,0.458596,Difference in the time to first pulmonary exacerbation was not statistically significant (P=0.11).,"[{'ForeName': 'Jinming', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Lun', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Jiang', 'Affiliation': 'Department of Medicine, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liao', 'Affiliation': 'Department of Medicine, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Lingfei', 'Initials': 'L', 'LastName': 'Kong', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Yuanlin', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jinfu', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Shanghai Pulmonary Hospital, Tongji University, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Chengli', 'Initials': 'C', 'LastName': 'Que', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, First Hospital of Peking University, Beijing, China.'}, {'ForeName': 'Roy A', 'Initials': 'RA', 'LastName': 'Pleasants', 'Affiliation': 'Division of Pulmonary Medicine and Critical Care, Chapel Hill, NC, USA.'}]",Journal of thoracic disease,['10.21037/jtd-20-1662'] 3493,33841952,Recurrence of primary spontaneous pneumothorax following bullectomy with pleurodesis or pleurectomy: A retrospective analysis.,"Background Primary spontaneous pneumothorax is managed initially with observation and chest tube placement, followed by surgical intervention in select cases. With little currently published evidence, the role of surgical pleurodesis or pleurectomy to reduce primary spontaneous pneumothorax recurrence is unclear. This study compares the recurrence rates of primary spontaneous pneumothorax following bullectomy alone versus bullectomy with pleurodesis or pleurectomy. Methods A retrospective review was performed at a quaternary hospital for all patients undergoing surgery for primary spontaneous pneumothorax between June 2006 and December 2018. Patient demographics, disease severity, operative technique, and time between initial surgery and recurrence were recorded. Standard statistical techniques were used for univariable and multivariable analyses. Results Of 222 total included patients, 28 required a second surgery: 4 (1.8%) for prolonged air leak and 24 (10.8%) for recurrent pneumothorax. The median time from first to second surgery was 363 days and 35.7% of recurrences did not present until after two years. Age, sex, smoking, year of initial surgery, disease severity, and surgical technique did not significantly affect recurrence rate on univariable analysis. On multivariable analysis, the odds ratios of recurrence for bullectomy with mechanical pleurodesis or pleurectomy were respectively 0.82 and 0.15 (P=0.218), compared to bullectomy alone. Combined bullectomy, pleurectomy, and pleurodesis was most effective (0/18, 0%). Conclusions Bullectomy with pleurectomy and pleurodesis demonstrated a 0% recurrence rate for the treatment of primary spontaneous pneumothorax in this study. Statistical significance was not achieved in univariable or multivariable analyses comparing recurrence rates for the surgical approaches. A multi-center randomized controlled trial with longer follow-up than previously performed is needed to confirm these preliminary findings and optimize surgical management of primary spontaneous pneumothorax.",2021,"On multivariable analysis, the odds ratios of recurrence for bullectomy with mechanical pleurodesis or pleurectomy were respectively 0.82 and 0.15","['222 total included patients', 'primary spontaneous pneumothorax', 'patients undergoing surgery for primary spontaneous pneumothorax between June 2006 and December 2018']","['bullectomy alone versus bullectomy with pleurodesis or pleurectomy', 'bullectomy with pleurodesis or pleurectomy']","['recurrence rate', 'median time', 'recurrent pneumothorax', 'prolonged air leak', 'Patient demographics, disease severity, operative technique, and time between initial surgery and recurrence']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1868193', 'cui_str': 'Primary spontaneous pneumothorax'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0189557', 'cui_str': 'Pleurodesis'}, {'cui': 'C0152463', 'cui_str': 'Pleurectomy'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",,0.104978,"On multivariable analysis, the odds ratios of recurrence for bullectomy with mechanical pleurodesis or pleurectomy were respectively 0.82 and 0.15","[{'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Brophy', 'Affiliation': 'Division of General Surgery, Department of Surgery, Dalhousie University, Queen Elizabeth II Hospital - Victoria Campus, Halifax, NS, Canada.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Brennan', 'Affiliation': 'Dalhousie Medical School, Department of Surgery, Dalhousie University, Queen Elizabeth II Hospital - Victoria Campus, Halifax, NS, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'French', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, Dalhousie University, Queen Elizabeth II Hospital - Victoria Campus, Halifax, NS, Canada.'}]",Journal of thoracic disease,['10.21037/jtd-20-3257'] 3494,33841889,Weight loss with or without intragastric balloon causes divergent effects on ghrelin cell expression.,"Objective The mechanism of action of intragastric balloons in the treatment of obesity is not fully understood. One of the hypotheses is that balloons might have an effect on the fundus, the area of ghrelin production. Methods Participants were randomized to a 13-week period of sham or balloon treatment followed by a 13-week period of balloon therapy in everyone. Blood samples for ghrelin levels were taken in the fasting state and after a breakfast at the start, after 13 and 26 weeks. Biopsies for ghrelin cell immunohistochemistry were taken from the fundus at endoscopy. Results Seven participants entered the balloon-balloon (BB) group and 11 the sham-balloon (SB) group. Despite a considerable weight loss, a median -17.9 kg (interquartile ranges -23.8 to -0.5) in the BB group and -18.3 kg (-22.7 to -14.7) in the SB group, fasting ghrelin and meal-induced ghrelin response did not change. In the SB group, the number of ghrelin cells increased significantly ( p 0.001) from 110.6 (83.6-118.9) to 160.2 (128.5-223.0) while on sham treatment and returned to initial levels, 116.3 (91.7-146.9) ( p 0.001), when they received their first balloon. No significant changes in ghrelin cell numbers were observed in the BB group. Conclusion In participants without a balloon, weight loss induced an increase in ghrelin cell numbers in the fundus, which was annulled by the subsequent placement of a balloon. The effect of a balloon might be explained by effects on ghrelin cell numbers or ghrelin cell activity.",2021,"In the SB group, the number of ghrelin cells increased significantly ( p 0.001) from 110.6 (83.6-118.9) to 160.2 (128.5-223.0) while on sham treatment and returned to initial levels, 116.3 (91.7-146.9) ( p 0.001), when they received their first balloon.",[],"['sham or balloon treatment', 'balloon therapy']","['ghrelin cell numbers', 'ghrelin cell expression', 'number of ghrelin cells', 'Weight loss', 'weight loss']",[],"[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.128761,"In the SB group, the number of ghrelin cells increased significantly ( p 0.001) from 110.6 (83.6-118.9) to 160.2 (128.5-223.0) while on sham treatment and returned to initial levels, 116.3 (91.7-146.9) ( p 0.001), when they received their first balloon.","[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Mathus-Vliegen', 'Affiliation': 'Department of Gastroenterology and Hepatology Academic Medical Centre (AMC) University of Amsterdam Amsterdam the Netherlands.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Spångeus', 'Affiliation': 'Department of Health, Medicine and Caring Sciences Division of Diagnostics and Specialist Medicine Linköping University Linköping Sweden.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Walter', 'Affiliation': 'Department of Biomedical and Clinical Sciences Division of Inflammation and Infection Medical Faculty Linköping University Linköping Sweden.'}, {'ForeName': 'Ann-Charlott', 'Initials': 'AC', 'LastName': 'Ericson', 'Affiliation': 'Department of Biomedical and Clinical Sciences Division of Molecular Medicine and Virology Medical Faculty Linköping University Linköping Sweden.'}]",Obesity science & practice,['10.1002/osp4.478'] 3495,33841733,Management of dental anxiety via distraction technique.,"Background The purpose of this study was to evaluate the use of a stress ball as a distraction technique on stress levels of patients undergoing a dental procedure. Material and Methods A randomized, split-mouth design was conducted using 20 adult subjects requiring scaling and root planing (Sc/RP) in all four quadrants. Each side of the mouth (maxillary/mandibular) received Sc/RP with local anesthetic with or without the use of a stress-ball distraction over two separate sessions. Subjects completed two pre-procedural questionnaires (Spielberger State-Trait Anxiety Inventory, STAI; Modified Dental Anxiety Scale, MDAS) before and after each treatment session. A Galvanic Skin Response (GSR) sensor (Neulog) was used throughout each session to measure skin conductance or sweat. Results No significant difference in GSR scores was found during treatment with or without the use of the stress ball. Also, no significant differences in the change in STAI or MDAS scores were found with or without the use of a stress ball. Conclusions The results of this study found that the use of a stress ball as a distraction technique did not result in any significant reduction in stress levels in subjects undergoing scaling and root planing with local anesthesia. Key words: Anxiety, distraction, stress ball.",2021,"Also, no significant differences in the change in STAI or MDAS scores were found with or without the use of a stress ball. ","['patients undergoing a dental procedure', '20 adult subjects requiring scaling and root planing (Sc/RP) in all four quadrants', 'subjects undergoing scaling and root planing with local anesthesia']","['Galvanic Skin Response (GSR) sensor (Neulog', 'Sc/RP with local anesthetic with or without the use of a stress-ball distraction', 'distraction technique', 'dental anxiety via distraction technique']","['GSR scores', 'stress levels', 'pre-procedural questionnaires (Spielberger State-Trait Anxiety Inventory, STAI; Modified Dental Anxiety Scale, MDAS', 'change in STAI or MDAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011331', 'cui_str': 'Dental care'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C0439738', 'cui_str': 'Four quadrants'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}]","[{'cui': 'C0016989', 'cui_str': 'Galvanic skin response'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0085380', 'cui_str': 'Dental phobia'}]","[{'cui': 'C0016989', 'cui_str': 'Galvanic skin response'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451497', 'cui_str': 'Spielberger state-trait anxiety inventory'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0085380', 'cui_str': 'Dental phobia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}]",20.0,0.0148243,"Also, no significant differences in the change in STAI or MDAS scores were found with or without the use of a stress ball. ","[{'ForeName': 'Job', 'Initials': 'J', 'LastName': 'Torres-Gomez', 'Affiliation': 'DMD, MS. Capt, USAF, DC. Deputy Program Director. Advanced Education in General Dentistry Residency. Air Force Postgraduate Dental School. Uniformed Services University of the Health Sciences. 2501 Capehart Rd. Offutt, Air Force Base, Bellevue, NE, USA.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Arnason', 'Affiliation': 'DDS, MS. Maj, USAF, DC. Training Officer. Advanced Education in General Dentistry Residency. Air Force Postgraduate Dental School. Uniformed Services University of the Health Sciences. 1615 Truemper St. Joint Base San Antonio - Lackland, TX, USA.'}, {'ForeName': 'Wyeth L', 'Initials': 'WL', 'LastName': 'Hoopes', 'Affiliation': 'DDS, MS. Maj, USAF, DC. Training Officer. Advanced Education in General Dentistry Residency. Air Force Postgraduate Dental School. Uniformed Services University of the Health Sciences. 1615 Truemper St. Joint Base San Antonio - Lackland, TX, USA.'}, {'ForeName': 'Kraig S', 'Initials': 'KS', 'LastName': 'Vandewalle', 'Affiliation': 'DDS, MS. Col (ret), USAF, DC. Director of Dental Research. Advanced Education in General Dentistry Residency. Air Force Postgraduate Dental School. Uniformed Services University of the Health Sciences. 1615 Truemper St. Joint Base San Antonio - Lackland, TX, USA.'}]",Journal of clinical and experimental dentistry,['10.4317/jced.57660'] 3496,33841710,The application effect analysis of personalized health education in acute leukemia nursing.,"OBJECTIVE To analyze the effectiveness of personalized health education care in the nursing of patients with acute leukemia. METHODS A total of 108 patients with leukemia who were admitted to our hospital were randomly selected as research subjects. A random number table was used to allocate the patients into the observation group and the control group, with 54 patients in each group. The control group had routine health education care and the observation group received personalized health education care in addition to treatment given to the control group. The knowledge of leukemia, bad moods, adverse reaction and nursing satisfaction were compared between the two groups. RESULTS The observation group had better knowledge of leukemia and nursing satisfaction than the control group, and the incidence of bad moods (anxiety, depression) and adverse reactions were lower than that in the control group (all P<0.05). CONCLUSION The application of personalized health education in the nursing of acute leukemia patients was significant, which improved the knowledge of acute leukemia, reduced the incidence of bad moods and adverse reactions, and improved nursing satisfaction.",2021,"The observation group had better knowledge of leukemia and nursing satisfaction than the control group, and the incidence of bad moods (anxiety, depression) and adverse reactions were lower than that in the control group (all P<0.05). ","['108 patients with leukemia who were admitted to our hospital were randomly selected as research subjects', 'patients with acute leukemia', 'acute leukemia nursing']","['personalized health education care', 'routine health education care and the observation group received personalized health education care', 'personalized health education']","['incidence of bad moods (anxiety, depression) and adverse reactions', 'knowledge of leukemia, bad moods, adverse reaction and nursing satisfaction', 'knowledge of leukemia and nursing satisfaction']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1509146', 'cui_str': 'Bad mood'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",108.0,0.0321664,"The observation group had better knowledge of leukemia and nursing satisfaction than the control group, and the incidence of bad moods (anxiety, depression) and adverse reactions were lower than that in the control group (all P<0.05). ","[{'ForeName': 'Cuiping', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of Soochow University Suzhou, Jiangsu Province, China.'}, {'ForeName': 'Yanqin', 'Initials': 'Y', 'LastName': 'Mao', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of Soochow University Suzhou, Jiangsu Province, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Tang', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of Soochow University Suzhou, Jiangsu Province, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of Soochow University Suzhou, Jiangsu Province, China.'}]",American journal of translational research,[] 3497,33841709,Study on the effects of desloratadine citrate disodium on the postoperative complications and inflammatory response in patients with chronic sinusitis undergoing endoscopic sinus surgery.,"OBJECTIVE To explore the effects of desloratadine citrate disodium on the postoperative complications and inflammatory markers in patients with chronic sinusitis undergoing endoscopic sinus surgery. METHODS From June 2019 to December 2020, the patients with chronic sinusitis who received treatment in our hospital were selected and divided into the control group (CG) and experimental group (EG). In both groups, patients were given endoscopic sinus surgery. On this basis, patients were treated with desloratadine citrate disodium in the EG. The total effective rate of the operation and the incidence of complications were compared between the two groups, and the VAS scores of clinical symptoms were compared between the two groups after treatment. Meanwhile, the changes of serum TIgE, ECP and inflammatory factors were compared between the two groups, and the nasal mucociliary clearing function was compared between the two groups before and after treatment. RESULTS After treatment, the total effective rate was 94.9% in the EG, which was significantly higher than that in the CG (82.2%). The levels of serum interleukin-6 (IL-6), interleukin-8 (IL-8), high-sensitivity C-reactive protein (hs-CRP) and tumor necrosis factor-α (TNF-α) in the EG were significantly lower than those in the CG, and the levels of serum TIgE and ECP were also significantly lower than those in the CG. After treatment for 3 months, the mucociliary clearance rate and mucociliary clearance rate in the EG were significantly higher than those in the CG, while the saccharin clearance time was significantly shorter than that in the CG. The incidence of complications in the EG was significantly lower than that in the CG (all P < 0.05). CONCLUSION Desloratadine citrate disodium combined with endoscopic sinus surgery can improve the clinical efficacy, reduce the level of inflammatory factors and effectively reduce the incidence of complications in patients with chronic sinusitis.",2021,"The incidence of complications in the EG was significantly lower than that in the CG (all P < 0.05). ","['patients with chronic sinusitis', 'patients with chronic sinusitis undergoing endoscopic sinus surgery', 'From June 2019 to December 2020, the patients with chronic sinusitis who received treatment in our hospital']","['endoscopic sinus surgery', 'desloratadine citrate disodium', 'control group (CG) and experimental group (EG', 'Desloratadine citrate disodium']","['VAS scores of clinical symptoms', 'clinical efficacy', 'incidence of complications', 'mucociliary clearance rate and mucociliary clearance rate', 'total effective rate of the operation and the incidence of complications', 'postoperative complications and inflammatory response', 'total effective rate', 'levels of serum TIgE and ECP', 'nasal mucociliary clearing function', 'saccharin clearance time', 'serum TIgE, ECP and inflammatory factors', 'postoperative complications and inflammatory markers', 'levels of serum interleukin-6 (IL-6), interleukin-8 (IL-8), high-sensitivity C-reactive protein (hs-CRP) and tumor necrosis factor-α (TNF-α']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149516', 'cui_str': 'Chronic sinusitis'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}, {'cui': 'C0252352', 'cui_str': 'des(ethoxycarbonyl)loratadine'}, {'cui': 'C0008857', 'cui_str': 'Citrates'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026687', 'cui_str': 'Mucociliary clearance'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0036023', 'cui_str': 'Saccharin'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}]",,0.0297316,"The incidence of complications in the EG was significantly lower than that in the CG (all P < 0.05). ","[{'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Ma', 'Affiliation': 'Department of Otolaryngology, The First Affiliated Hospital of Anhui Medical University Hefei 238000, Anhui Province, China.'}, {'ForeName': 'Longsheng', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Otolaryngology, Chaohu Hospital of Anhui Medical University Chaohu 238000, Anhui Province, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Jin', 'Affiliation': 'Department of Otolaryngology, Chaohu Hospital of Anhui Medical University Chaohu 238000, Anhui Province, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Otolaryngology, Chaohu Hospital of Anhui Medical University Chaohu 238000, Anhui Province, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'Department of Otolaryngology, Chaohu Hospital of Anhui Medical University Chaohu 238000, Anhui Province, China.'}, {'ForeName': 'Busheng', 'Initials': 'B', 'LastName': 'Tong', 'Affiliation': 'Department of Otolaryngology, The First Affiliated Hospital of Anhui Medical University Hefei 238000, Anhui Province, China.'}]",American journal of translational research,[] 3498,33841708,Practical value of hierarchical teaching combined with simulation scenario training for operating-room nurses.,"OBJECTIVE This study explored the application value of combined training by hierarchical teaching with situational simulations for operating-room (OR) nurses. METHODS A total of 41 nurses that received pre-job training for the operating room from January 2018 to December 2019 were selected as the research subjects and randomly divided into a control group and a study group. The control group was given the hierarchical nurse-teaching method, while the study group was given combined training with the hierarchical teaching and scenario simulations. In this study, the operating room capability, clinical work ability, results of theoretical assessment and specialized operation, and nurses' satisfaction with the teaching patterns were compared between the two groups. RESULTS After training, the scores of the operating-room operations in the study group, such as laying of aseptic towels, surgical hand washing, wearing of surgical gowns and gloves, and the setting up of the operating table, were higher than that in the control group ( P <0.05). The scores of clinical work abilities in the study group, such as emergency handling ability, standardized operation ability, mastery of professional knowledge, observation and evaluation ability of disease, and clinical thinking ability, were higher than those in the control group ( P <0.05). The theoretical examination scores and specialized operation scores of nurses in the study group were higher than those in the control group ( P <0.05). The satisfaction with the degree of teaching methods in the study group was higher than that in the control group ( P <0.05). CONCLUSION The application of the combined training methods of hierarchical teaching with situational simulations for OR nurses can effectively improve their operational and clinical work ability, deepen their mastery of theoretical knowledge, and enable junior nurses to master the professional skills required in the operating room in a faster way, which is worthy of clinical teaching application.",2021,"The scores of clinical work abilities in the study group, such as emergency handling ability, standardized operation ability, mastery of professional knowledge, observation and evaluation ability of disease, and clinical thinking ability, were higher than those in the control group ( P <0.05).","['operating-room nurses', '41 nurses that received pre-job training for the operating room from January 2018 to December 2019 were selected as the research subjects']","['combined training with the hierarchical teaching and scenario simulations', 'hierarchical teaching combined with simulation scenario training']","['theoretical examination scores and specialized operation scores of nurses', 'laying of aseptic towels, surgical hand washing, wearing of surgical gowns and gloves', 'scores of clinical work abilities', 'satisfaction with the degree of teaching methods', 'emergency handling ability, standardized operation ability, mastery of professional knowledge, observation and evaluation ability of disease, and clinical thinking ability']","[{'cui': 'C0029064', 'cui_str': 'Operating theatre'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0021599', 'cui_str': 'Training, Inservice'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0232920', 'cui_str': 'Sterile'}, {'cui': 'C0336616', 'cui_str': 'Towel'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0181066', 'cui_str': 'Surgical Gowns'}, {'cui': 'C0206069', 'cui_str': 'Glove'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039403', 'cui_str': 'Teaching Methods'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0018578', 'cui_str': 'Handling (Psychology)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",41.0,0.0215551,"The scores of clinical work abilities in the study group, such as emergency handling ability, standardized operation ability, mastery of professional knowledge, observation and evaluation ability of disease, and clinical thinking ability, were higher than those in the control group ( P <0.05).","[{'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Operating-Room of The Second Affiliated Hospital of Soochow University Suzhou 215004, Jiangsu, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'Operating-Room of The Second Affiliated Hospital of Soochow University Suzhou 215004, Jiangsu, China.'}, {'ForeName': 'Yanling', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Operating-Room of The Second Affiliated Hospital of Soochow University Suzhou 215004, Jiangsu, China.'}]",American journal of translational research,[] 3499,33841705,"Effect of endovascular therapy on the expression levels of serum T lymphocyte subsets, Notch1 and TACE proteins in patients with abdominal aortic aneurysm.","To investigate the effect of endovascular therapy on the expression levels of serum T lymphocyte subsets, Notch1 and TACE proteins in patients with abdominal aortic aneurysm (AAA). A total of 84 AAA patients treated in the General Hospital of Northern Theater Command of Chinese PLA from January 2018 to October 2019 were equally divided into the control group and research group according to different surgical methods. The control group underwent laparotomy and the research group received endoluminal repair. The expression levels of serum T-cell subsets, plasma Notch1 and TACE proteins were compared before and 1 week after surgery between the two groups; the expression levels of plasma Notch1 and TACE proteins in patients with different tumor diameters in the research group were compared; the comparison of the surgical indexes and the incidence of complications was conducted. After treatment, the molecular level of CD3 + and CD4 + in the research group was significantly higher than that in the control group, whereas the molecular level of CD8 + , and the expression levels of Notch1 and TACE proteins in the plasma were significantly lower than that in the control group (P < 0.05). In the research group, the expression levels of plasma Notch1 and TACE proteins were in direct proportion with tumor diameter (P < 0.05). The intraoperative blood loss in the research group was significantly less than that in the control group, the operation time, postoperative fasting time and postoperative hospital stay were significantly shorter than that in the control group, and the total incidence of complications (11.90%) was significantly lower than that in the control group (38.09%) (P < 0.05). At 12 months after operation, there was no statistically significant difference in the incidence of complications and mortality between the two groups. Endovascular therapy fro AAA can greatly improve the expression levels of T-lymphocyte subsets, Notch1 and TACE proteins, and markedly reduce the incidence of complications.",2021,"At 12 months after operation, there was no statistically significant difference in the incidence of complications and mortality between the two groups.","['patients with abdominal aortic aneurysm', '84 AAA patients treated in the General Hospital of Northern Theater Command of Chinese PLA from January 2018 to October 2019', 'patients with abdominal aortic aneurysm (AAA']","['endovascular therapy', 'laparotomy and the research group received endoluminal repair']","['incidence of complications and mortality', 'total incidence of complications', 'molecular level of CD3 + and CD4 ', 'expression levels of serum T lymphocyte subsets, Notch1 and TACE proteins', 'operation time, postoperative fasting time and postoperative hospital stay', 'molecular level of CD8 + , and the expression levels of Notch1 and TACE proteins in the plasma', 'expression levels of serum T-cell subsets, plasma Notch1 and TACE proteins', 'expression levels of plasma Notch1 and TACE proteins', 'intraoperative blood loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162871', 'cui_str': 'Abdominal aortic aneurysm'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0475307', 'cui_str': 'Theatre'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0376410', 'cui_str': 'Endoluminal Repair'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0080202', 'cui_str': 'T-Cell Subsets'}, {'cui': 'C1335068', 'cui_str': 'NOTCH1 protein, human'}, {'cui': 'C0529196', 'cui_str': 'Tumor Necrosis Factor-alpha Converting Enzyme'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",84.0,0.0155374,"At 12 months after operation, there was no statistically significant difference in the incidence of complications and mortality between the two groups.","[{'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': 'Department of Interventional Vascular Surgery, General Hospital of Northern Theater Command of Chinese PLA Shenyang 110016, Liaoning Province, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Interventional Vascular Surgery, General Hospital of Northern Theater Command of Chinese PLA Shenyang 110016, Liaoning Province, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Xia', 'Affiliation': 'Department of Interventional Vascular Surgery, General Hospital of Northern Theater Command of Chinese PLA Shenyang 110016, Liaoning Province, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Shan', 'Affiliation': 'Department of Interventional Vascular Surgery, General Hospital of Northern Theater Command of Chinese PLA Shenyang 110016, Liaoning Province, China.'}, {'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Interventional Vascular Surgery, General Hospital of Northern Theater Command of Chinese PLA Shenyang 110016, Liaoning Province, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, Air Force Hospital of Northern Theater Command of Chinese PLA Shenyang 110042, Liaoning Province, China.'}]",American journal of translational research,[] 3500,33844568,Acceptability and feasibility of incorporating contingency management into a public treatment program for homeless crack cocaine users in Brazil: A pilot study.,"Homeless substance users are particularly hard to treat. In this pilot study, we evaluated the acceptability and feasibility of incorporating Contingency Management (CM) into a public Abstinent-Contingent Housing (ACH) treatment program developed to treat currently homeless crack cocaine users. A total of 21 homeless crack cocaine users were randomized to receive 12 weeks of ACH alone (n = 9) or ACH plus CM (ACH + CM) (n = 12). Twelve treatment providers in the ACH treatment program were trained to deliver the CM intervention. CM was rated as relatively (41.7%) or very (58.3%) easy to understand and relatively (50%) or very (50%) easy to conduct by the ACH treatment providers. On a 10-point Likert scale, providers rated the importance of incorporating CM into public treatment programs for crack cocaine at M = 8.3 (SD = 2). Participants exposed to CM rated as relatively (33.3%) or very (66.7%) easy to understand. One hundred percent liked receiving the intervention ""a lot,"" and 78.9% believed it helped them achieve and maintain crack cocaine abstinence. Finally, compared to the ACH condition, the ACH + CM condition was consistently associated with better treatment retention and cocaine use outcome measures, yelling small to large effect sizes. However, possibly due to the small sample size, most of these differences did not achieve statistical significance. CM was well integrated into the ACH treatment program and was well accepted by both the providers and participants, suggesting the feasibility of incorporating CM into a public treatment program for homeless crack cocaine users from low- and middle-income countries. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"Finally, compared to the ACH condition, the ACH + CM condition was consistently associated with better treatment retention and cocaine use outcome measures, yelling small to large effect sizes.","['homeless crack cocaine users from low- and middle-income countries', '21 homeless crack cocaine users', 'homeless crack cocaine users in Brazil', 'Homeless substance users', 'homeless crack cocaine users']","['ACH alone', 'contingency management into a public treatment program', 'Contingency Management (CM', 'public Abstinent-Contingent Housing (ACH) treatment program', 'CM intervention', 'ACH plus CM (ACH + CM']","['acceptability and feasibility', 'Acceptability and feasibility']","[{'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0085163', 'cui_str': 'Cocaine freebase'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0338666', 'cui_str': 'Misuses drugs'}]","[{'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0293454,"Finally, compared to the ACH condition, the ACH + CM condition was consistently associated with better treatment retention and cocaine use outcome measures, yelling small to large effect sizes.","[{'ForeName': 'André Q C', 'Initials': 'AQC', 'LastName': 'Miguel', 'Affiliation': 'Department of Psychiatry, Federal University of São Paulo.'}, {'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'Simões', 'Affiliation': 'Department of Psychiatry, Federal University of São Paulo.'}, {'ForeName': 'Rodolfo', 'Initials': 'R', 'LastName': 'Yamauchi', 'Affiliation': 'Department of Psychiatry, Federal University of São Paulo.'}, {'ForeName': 'Clarice S', 'Initials': 'CS', 'LastName': 'Madruga', 'Affiliation': 'Department of Psychiatry, Federal University of São Paulo.'}, {'ForeName': 'Claudio J', 'Initials': 'CJ', 'LastName': 'da Silva', 'Affiliation': 'Department of Psychiatry, Federal University of São Paulo.'}, {'ForeName': 'Ronaldo R', 'Initials': 'RR', 'LastName': 'Laranjeira', 'Affiliation': 'Department of Psychiatry, Federal University of São Paulo.'}, {'ForeName': 'Crystal L', 'Initials': 'CL', 'LastName': 'Smith', 'Affiliation': 'Elson S. Floyd College of Medicine, Washington State University.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Roll', 'Affiliation': 'Elson S. Floyd College of Medicine, Washington State University.'}, {'ForeName': 'Sterling', 'Initials': 'S', 'LastName': 'McPherson', 'Affiliation': 'Elson S. Floyd College of Medicine, Washington State University.'}, {'ForeName': 'Jair J', 'Initials': 'JJ', 'LastName': 'Mari', 'Affiliation': 'Department of Psychiatry, Federal University of São Paulo.'}]",Experimental and clinical psychopharmacology,['10.1037/pha0000467'] 3501,33844484,Augmentation of fear extinction by theta-burst transcranial magnetic stimulation of the prefrontal cortex in humans.,"Background Fear extinction alone does not erase the original fear memory. Interventions that enhance extinction can be beneficial for the treatment of fear-related disorders. Repetitive transcranial magnetic stimulation has been shown to improve memory performance. The present study examined the effects of intermittent theta-burst stimulation (iTBS) on fear extinction and the return of fear memory in humans. Methods Ninety-one young healthy volunteers underwent 3 experiments using a randomized controlled experimental design. Participants first acquired fear conditioning, after which they received 30 Hz iTBS before and after extinction training. The iTBS was applied to 1 of 2 targets: the left dorsolateral prefrontal cortex (dlPFC) and the vertex (control). Fear responses were measured 24 hours later and 1 month later. Results During the spontaneous recovery and reinstatement tests, iTBS of the left dlPFC before and after extinction significantly reduced fear response, whereas iTBS of the vertex had no effect on fear memory performance. This combined approach had a relatively long-lasting effect (i.e., at least 1 month). Limitations We did not explore the effect of iTBS of the dlPFC on the expression of fear without extinction training. The neural mechanisms of iTBS with fear extinction to inhibit the fear response are unclear. Our results are preliminary and should be interpreted with caution. Conclusion `The present results showed that 30 Hz iTBS of the left dlPFC enhanced retention of fear extinction. Our study introduces a new intervention for fear memory and suggests that the left dlPFC may be a treatment target for fear-related disorders.",2021,"During the spontaneous recovery and reinstatement tests, iTBS of the left dlPFC before and after extinction significantly reduced fear response, whereas iTBS of the vertex had no effect on fear memory performance.","['Methods\n\n\nNinety-one young healthy volunteers', 'humans']","['intermittent theta-burst stimulation (iTBS', 'fear extinction by theta-burst transcranial magnetic stimulation', 'Repetitive transcranial magnetic stimulation']","['fear response', 'memory performance', 'fear memory performance', 'fear extinction and the return of fear memory', 'Fear responses', 'retention of fear extinction']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C1285654', 'cui_str': 'Memory performance'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",91.0,0.0125691,"During the spontaneous recovery and reinstatement tests, iTBS of the left dlPFC before and after extinction significantly reduced fear response, whereas iTBS of the vertex had no effect on fear memory performance.","[{'ForeName': 'Jiahui', 'Initials': 'J', 'LastName': 'Deng', 'Affiliation': ""From the Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Chinese Academy of Medical Sciences Research Unit (No. 2018RU006), Peking University, Beijing 100191, China (Deng, Gong, Li, Su, Sun, Lu, Shi, Sun); the Psychological Hospital Affiliated with Anhui Medical University, Anhui Mental Health Center, Hefei Fourth People's Hospital, Hefei 230022, China (Feng); the National Institute on Drug Dependence and Beijing Key Laboratory of Drug Dependence, Peking University, Beijing 100191, China (Bao); and the Peking-Tsinghua Center for Life Sciences and PKU-IDG/McGovern Institute for Brain Research, Peking University, Beijing 100191, China (Lu).""}, {'ForeName': 'Wenmei', 'Initials': 'W', 'LastName': 'Fang', 'Affiliation': ""From the Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Chinese Academy of Medical Sciences Research Unit (No. 2018RU006), Peking University, Beijing 100191, China (Deng, Gong, Li, Su, Sun, Lu, Shi, Sun); the Psychological Hospital Affiliated with Anhui Medical University, Anhui Mental Health Center, Hefei Fourth People's Hospital, Hefei 230022, China (Feng); the National Institute on Drug Dependence and Beijing Key Laboratory of Drug Dependence, Peking University, Beijing 100191, China (Bao); and the Peking-Tsinghua Center for Life Sciences and PKU-IDG/McGovern Institute for Brain Research, Peking University, Beijing 100191, China (Lu).""}, {'ForeName': 'Yimiao', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': ""From the Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Chinese Academy of Medical Sciences Research Unit (No. 2018RU006), Peking University, Beijing 100191, China (Deng, Gong, Li, Su, Sun, Lu, Shi, Sun); the Psychological Hospital Affiliated with Anhui Medical University, Anhui Mental Health Center, Hefei Fourth People's Hospital, Hefei 230022, China (Feng); the National Institute on Drug Dependence and Beijing Key Laboratory of Drug Dependence, Peking University, Beijing 100191, China (Bao); and the Peking-Tsinghua Center for Life Sciences and PKU-IDG/McGovern Institute for Brain Research, Peking University, Beijing 100191, China (Lu).""}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Bao', 'Affiliation': ""From the Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Chinese Academy of Medical Sciences Research Unit (No. 2018RU006), Peking University, Beijing 100191, China (Deng, Gong, Li, Su, Sun, Lu, Shi, Sun); the Psychological Hospital Affiliated with Anhui Medical University, Anhui Mental Health Center, Hefei Fourth People's Hospital, Hefei 230022, China (Feng); the National Institute on Drug Dependence and Beijing Key Laboratory of Drug Dependence, Peking University, Beijing 100191, China (Bao); and the Peking-Tsinghua Center for Life Sciences and PKU-IDG/McGovern Institute for Brain Research, Peking University, Beijing 100191, China (Lu).""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""From the Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Chinese Academy of Medical Sciences Research Unit (No. 2018RU006), Peking University, Beijing 100191, China (Deng, Gong, Li, Su, Sun, Lu, Shi, Sun); the Psychological Hospital Affiliated with Anhui Medical University, Anhui Mental Health Center, Hefei Fourth People's Hospital, Hefei 230022, China (Feng); the National Institute on Drug Dependence and Beijing Key Laboratory of Drug Dependence, Peking University, Beijing 100191, China (Bao); and the Peking-Tsinghua Center for Life Sciences and PKU-IDG/McGovern Institute for Brain Research, Peking University, Beijing 100191, China (Lu).""}, {'ForeName': 'Sizhen', 'Initials': 'S', 'LastName': 'Su', 'Affiliation': ""From the Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Chinese Academy of Medical Sciences Research Unit (No. 2018RU006), Peking University, Beijing 100191, China (Deng, Gong, Li, Su, Sun, Lu, Shi, Sun); the Psychological Hospital Affiliated with Anhui Medical University, Anhui Mental Health Center, Hefei Fourth People's Hospital, Hefei 230022, China (Feng); the National Institute on Drug Dependence and Beijing Key Laboratory of Drug Dependence, Peking University, Beijing 100191, China (Bao); and the Peking-Tsinghua Center for Life Sciences and PKU-IDG/McGovern Institute for Brain Research, Peking University, Beijing 100191, China (Lu).""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': ""From the Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Chinese Academy of Medical Sciences Research Unit (No. 2018RU006), Peking University, Beijing 100191, China (Deng, Gong, Li, Su, Sun, Lu, Shi, Sun); the Psychological Hospital Affiliated with Anhui Medical University, Anhui Mental Health Center, Hefei Fourth People's Hospital, Hefei 230022, China (Feng); the National Institute on Drug Dependence and Beijing Key Laboratory of Drug Dependence, Peking University, Beijing 100191, China (Bao); and the Peking-Tsinghua Center for Life Sciences and PKU-IDG/McGovern Institute for Brain Research, Peking University, Beijing 100191, China (Lu).""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': ""From the Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Chinese Academy of Medical Sciences Research Unit (No. 2018RU006), Peking University, Beijing 100191, China (Deng, Gong, Li, Su, Sun, Lu, Shi, Sun); the Psychological Hospital Affiliated with Anhui Medical University, Anhui Mental Health Center, Hefei Fourth People's Hospital, Hefei 230022, China (Feng); the National Institute on Drug Dependence and Beijing Key Laboratory of Drug Dependence, Peking University, Beijing 100191, China (Bao); and the Peking-Tsinghua Center for Life Sciences and PKU-IDG/McGovern Institute for Brain Research, Peking University, Beijing 100191, China (Lu).""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': ""From the Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Chinese Academy of Medical Sciences Research Unit (No. 2018RU006), Peking University, Beijing 100191, China (Deng, Gong, Li, Su, Sun, Lu, Shi, Sun); the Psychological Hospital Affiliated with Anhui Medical University, Anhui Mental Health Center, Hefei Fourth People's Hospital, Hefei 230022, China (Feng); the National Institute on Drug Dependence and Beijing Key Laboratory of Drug Dependence, Peking University, Beijing 100191, China (Bao); and the Peking-Tsinghua Center for Life Sciences and PKU-IDG/McGovern Institute for Brain Research, Peking University, Beijing 100191, China (Lu).""}, {'ForeName': 'Le', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': ""From the Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Chinese Academy of Medical Sciences Research Unit (No. 2018RU006), Peking University, Beijing 100191, China (Deng, Gong, Li, Su, Sun, Lu, Shi, Sun); the Psychological Hospital Affiliated with Anhui Medical University, Anhui Mental Health Center, Hefei Fourth People's Hospital, Hefei 230022, China (Feng); the National Institute on Drug Dependence and Beijing Key Laboratory of Drug Dependence, Peking University, Beijing 100191, China (Bao); and the Peking-Tsinghua Center for Life Sciences and PKU-IDG/McGovern Institute for Brain Research, Peking University, Beijing 100191, China (Lu).""}, {'ForeName': 'Hongqiang', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': ""From the Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Chinese Academy of Medical Sciences Research Unit (No. 2018RU006), Peking University, Beijing 100191, China (Deng, Gong, Li, Su, Sun, Lu, Shi, Sun); the Psychological Hospital Affiliated with Anhui Medical University, Anhui Mental Health Center, Hefei Fourth People's Hospital, Hefei 230022, China (Feng); the National Institute on Drug Dependence and Beijing Key Laboratory of Drug Dependence, Peking University, Beijing 100191, China (Bao); and the Peking-Tsinghua Center for Life Sciences and PKU-IDG/McGovern Institute for Brain Research, Peking University, Beijing 100191, China (Lu).""}]",Journal of psychiatry & neuroscience : JPN,['10.1503/jpn.200053'] 3502,33843621,ANALYSIS OF STUDENTS' SOMATIC HEALTH AND EMOTIONAL STATE DURING SPORTS GAMES CLASSES.,"OBJECTIVE The aim: Is to investigate the impact of sports games (football) on the level of somatic health and emotional state of students in the process of studying. PATIENTS AND METHODS Materials and methods: The study was conducted at Kharkiv State Academy of Physical Culture and Sumy State University (Ukraine) in 2018-2019. The study involved 87 male students of the main department. Two groups were formed: an experimental group (EG, n=42), the students of which were engaged in a sports-oriented form of physical education (in the class of football), and a control group (CG, n=45), the students of which were training according to the traditional methods of organizing physical education classes at higher education institutions. The somatic health of students was assessed according to the method of H. L. Apanasenko, which provided for the determination of body mass, life, power, and Robinson indexes, heart rate recovery time after a standard exercise. The emotional state of students was determined by the WAM (Well-being, Activity, Mood) methodology. RESULTS Results: At the end of the study, the EG students showed a significantly better level of somatic health than the CG students; the difference was significant and accounted for 3.18 points (p<0.001). At the same time, during the study, the EG students had a more pronounced significant increase in all studied health indicators (p<0.001). The best emotional state level of the students of both groups was recorded at the end of the study, but in the EG students it was significantly (p<0.05) better than in the CG students by 0.55-0.73 points. CONCLUSION Conclusions: It was found that sports games classes, including football, had a positive effect on the level of somatic health and emotional state of students. Significant changes were observed in the performance of the respiratory and cardiovascular systems of students. The high level of somatic health and good emotional state of students will help to improve mastering academic disciplines at higher education institutions, provide preparation for active life and help to improve future professional activities.",2021,"At the same time, during the study, the EG students had a more pronounced significant increase in all studied health indicators (p<0.001).","['Two groups were formed: an experimental group (EG, n=42), the students of which were engaged in a sports-oriented form of physical education (in the class of football), and a control group (CG, n=45), the students of which were training according to the traditional methods of organizing physical education classes at higher education institutions', 'Kharkiv State Academy of Physical Culture and Sumy State University (Ukraine) in 2018-2019', '87 male students of the main department']",['sports games (football'],"['emotional state level', 'level of somatic health', 'level of somatic health and emotional state of students', 'studied health indicators']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1300196', 'cui_str': 'Organized'}, {'cui': 'C0424933', 'cui_str': 'Higher education'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}]","[{'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",87.0,0.0639623,"At the same time, during the study, the EG students had a more pronounced significant increase in all studied health indicators (p<0.001).","[{'ForeName': 'Iryna I', 'Initials': 'II', 'LastName': 'Shaposhnikova', 'Affiliation': 'KHARKIV STATE ACADEMY OF PHYSICAL CULTURE, KHARKIV, UKRAINE.'}, {'ForeName': 'Svitlana M', 'Initials': 'SM', 'LastName': 'Korsun', 'Affiliation': 'KHARKIV STATE ACADEMY OF PHYSICAL CULTURE, KHARKIV, UKRAINE.'}, {'ForeName': 'Larysa P', 'Initials': 'LP', 'LastName': 'Arefieva', 'Affiliation': 'NATIONAL PEDAGOGICAL DRAGOMANOV UNIVERSITY, KYIV, UKRAINE.'}, {'ForeName': 'Olga V', 'Initials': 'OV', 'LastName': 'Kostikova', 'Affiliation': 'H.S. SKOVORODA KHARKIV NATIONAL PEDAGOGICAL UNIVERSITY, KHARKIV, UKRAINE.'}, {'ForeName': 'Volodymyr M', 'Initials': 'VM', 'LastName': 'Serhiіenko', 'Affiliation': 'SUMY STATE UNIVERSITY, SUMY, UKRAINE.'}, {'ForeName': 'Svitlana A', 'Initials': 'SA', 'LastName': 'Korol', 'Affiliation': 'SUMY STATE UNIVERSITY, SUMY, UKRAINE.'}, {'ForeName': 'Viktor G', 'Initials': 'VG', 'LastName': 'Riabchenko', 'Affiliation': 'ACADEMY OF THE STATE PENITENTIARY SERVICE, CHERNIHIV, UKRAINE.'}]","Wiadomosci lekarskie (Warsaw, Poland : 1960)",[] 3503,33843605,Virtual Reality Self-help Treatment for Aviophobia: Protocol for a Randomized Controlled Trial.,"BACKGROUND Aviophobia (the fear of flying) can greatly impact the daily life functioning of people with the condition. Traditional exposure-based treatment is hampered by the limited availability of airplane practice situations, which is a result of economical and practical concerns. Easily accessible and low-cost virtual reality exposure therapy may address these challenges. OBJECTIVE The purpose of our study is to investigate the effectiveness of ZeroPhobia: Aviophobia (a self-help mobile app-based treatment) in reducing flight anxiety symptoms and depressive and anxiety symptoms. We will also investigate the effects of usage intensity, the sense of immersion, inherent absorption ability, and perceived user-friendliness on the treatment effect. METHODS Participants (N=114) who are aged 18-64 years and experience at least mild symptoms of aviophobia will be recruited from the general Dutch population and randomized into a treatment group or waitlist control group. By using their own phones and rudimentary mobile virtual reality headsets, participants will receive six modules of psychoeducation and cognitive behavioral therapy, which will include six levels of virtual reality exposure therapy over a period of 6 weeks. Assessments will be conducted at baseline, posttest (ie, after 6 weeks), and 3- and 12-month follow-ups. The primary outcome measure of our study is the Flight Anxiety Situations Questionnaire. The secondary outcome measures include anxiety and depression measures and additional covariates (including usage intensity, the degree of immersion, etc). We will test treatment effectiveness by conducting an intention-to-treat analysis and estimating average treatment effects on the treated. The mechanisms of treatment effect will also be explored. RESULTS The study was funded on September 25, 2018. Ethical approval was received on October 11, 2019. Recruitment closed on May 7, 2020. CONCLUSIONS Our study will further the scientific understanding and clinical implications of technology's current ability to aid in providing effective, accessible treatment for the fear of flying. TRIAL REGISTRATION Netherlands Trial Registry NL70238.029.19; https://www.trialregister.nl/trial/8257. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/22008.",2021,"We will also investigate the effects of usage intensity, the sense of immersion, inherent absorption ability, and perceived user-friendliness on the treatment effect. ","['Participants (N=114) who are aged 18-64 years and experience at least mild symptoms of aviophobia will be recruited from the general Dutch population', 'people with the condition']","['ZeroPhobia: Aviophobia (a self-help mobile app-based treatment', 'psychoeducation and cognitive behavioral therapy', 'waitlist control group']","['flight anxiety symptoms and depressive and anxiety symptoms', 'anxiety and depression measures and additional covariates (including usage intensity, the degree of immersion, etc', 'Flight Anxiety Situations Questionnaire']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0436343', 'cui_str': 'Symptom mild'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.196217,"We will also investigate the effects of usage intensity, the sense of immersion, inherent absorption ability, and perceived user-friendliness on the treatment effect. ","[{'ForeName': 'Jamie Rhiannon', 'Initials': 'JR', 'LastName': 'Fehribach', 'Affiliation': 'Clinical Psychology, Department of Clinical, Neuro- and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Marieke Bianca Jolien', 'Initials': 'MBJ', 'LastName': 'Toffolo', 'Affiliation': 'Clinical Psychology, Department of Clinical, Neuro- and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Ilja', 'Initials': 'I', 'LastName': 'Cornelisz', 'Affiliation': 'Methods and Statistics, Department of Education Sciences, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'van Klaveren', 'Affiliation': 'Methods and Statistics, Department of Education Sciences, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Annemieke', 'Initials': 'A', 'LastName': 'van Straten', 'Affiliation': 'Clinical Psychology, Department of Clinical, Neuro- and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'van Gelder', 'Affiliation': 'Department of Criminology, Max Planck Institute for the Study of Crime, Security and Law, Freiburg, Germany.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Donker', 'Affiliation': 'Clinical Psychology, Department of Clinical, Neuro- and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}]",JMIR research protocols,['10.2196/22008'] 3504,33842613,Supercapsular percutaneously-assisted total hip (SuperPath) versus mini-incision posterolateral total hip arthroplasty for hip osteoarthritis: a prospective randomized controlled trial.,"Background Supercapsular percutaneously-assisted total hip (SuperPath) arthroplasty has been proposed to be minimally invasive and tissue sparing, with possible superior postoperative outcomes compared with conventional approaches for total hip arthroplasty (THA). However, previous studies have underlined the shortcomings of conventional THA approaches, including higher dislocation, more blood loss, longer incisions, more tissue damage, and delayed postoperative rehabilitation. In the present study, we compared the short-term outcomes of unilateral THA with those of SuperPath and the mini-incision posterolateral approach (PLA) for hip osteoarthritis (OA). Methods Patients with unilateral hip OA were prospectively recruited and underwent either SuperPath (SuperPath group) or mini-incision PLA THA (PLA group). Perioperative status [operative time, incision length, intraoperative blood loss, soft tissue damage, and length of hospital stay (LOS)], and postoperative function outcomes, including range of motion (ROM), pain visual analog scale (VAS), and Harris Hip Score (HHS), were evaluated and compared between the groups at scheduled time points within 12 months postoperatively. Results Compared with the PLA group, the SuperPath group yielded a significantly shorter incision length (7.83 vs. 12.45 cm, P<0.001), longer operative time (102.72 vs. 66.22 min, P<0.001), more blood loss (1,007.38 vs. 844.55 mL, P=0.005), and more soft tissue damage (creatine kinase: 1,056.05 vs. 821.50 U/L, P=0.006) on postoperative day 3. The SuperPath group also showed deficient acetabular cup positioning (abduction angle: 36.94° vs. 42.66°, P=0.004) and a greater decrease in ROM (flexion: 107.66° vs. 114.44°, P=0.004; 109.83° vs. 116.11°, P=0.002; 111.66° vs. 118.88°, P<0.001) on postoperative days 1, 3, and 14, as well as severe early-term pain symptoms (pain VAS on postoperative day 3: 7.05 vs. 6.55, P=0.041). However, the LOS, C-reactive protein levels, erythrocyte sedimentation rate (within 2 weeks postoperatively), and HHS were comparable between the groups during the 12 months postoperatively. Conclusions SuperPath may be a promising, minimally invasive technique for the treatment of OA in the future. Further investigation is necessary to evidence the possible superiority of SuperPath over other conventional mini-incision THA approaches.",2021,"Compared with the PLA group, the SuperPath group yielded a significantly shorter incision length (7.83 vs. 12.45 cm, P<0.001), longer operative time (102.72 vs. 66.22 min, P<0.001), more blood loss (1,007.38 vs. 844.55 mL, P=0.005), and more soft tissue damage (creatine kinase:","['hip osteoarthritis', 'Methods\n\n\nPatients with unilateral hip OA']","['SuperPath (SuperPath group) or mini-incision PLA THA (PLA group', 'Supercapsular percutaneously-assisted total hip (SuperPath) versus mini-incision posterolateral total hip arthroplasty', 'PLA', '\n\n\nSupercapsular percutaneously-assisted total hip (SuperPath) arthroplasty', 'unilateral THA with those of SuperPath and the mini-incision posterolateral approach (PLA']","['severe early-term pain symptoms (pain VAS', 'shorter incision length', 'LOS, C-reactive protein levels, erythrocyte sedimentation rate', 'ROM (flexion', 'Perioperative status [operative time, incision length, intraoperative blood loss, soft tissue damage, and length of hospital stay (LOS)], and postoperative function outcomes, including range of motion (ROM), pain visual analog scale (VAS), and Harris Hip Score (HHS', 'longer operative time', 'HHS', 'soft tissue damage (creatine kinase', 'acetabular cup positioning', 'blood loss']","[{'cui': 'C0029410', 'cui_str': 'Osteoarthritis of hip'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0587271', 'cui_str': 'Posterolateral approach'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0332195', 'cui_str': 'Posterolateral'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}]",,0.0327875,"Compared with the PLA group, the SuperPath group yielded a significantly shorter incision length (7.83 vs. 12.45 cm, P<0.001), longer operative time (102.72 vs. 66.22 min, P<0.001), more blood loss (1,007.38 vs. 844.55 mL, P=0.005), and more soft tissue damage (creatine kinase:","[{'ForeName': 'Weikun', 'Initials': 'W', 'LastName': 'Meng', 'Affiliation': 'Department of Orthopaedics, West China Hospital, West China School of Medicine, Sichuan University, Chengdu, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Center of Experimental Orthopaedics, Saarland University Medical Center, Homburg/Saar, Germany.'}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Orthopaedics, West China Hospital, West China School of Medicine, Sichuan University, Chengdu, China.'}, {'ForeName': 'Haoyang', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedics, West China Hospital, West China School of Medicine, Sichuan University, Chengdu, China.'}, {'ForeName': 'Duan', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedics, West China Hospital, West China School of Medicine, Sichuan University, Chengdu, China.'}, {'ForeName': 'Zeyu', 'Initials': 'Z', 'LastName': 'Luo', 'Affiliation': 'Department of Orthopaedics, West China Hospital, West China School of Medicine, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Department of Immunization, Yunnan Center for Disease Control and Prevention, Kunming, China.'}, {'ForeName': 'Guanglin', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedics, West China Hospital, West China School of Medicine, Sichuan University, Chengdu, China.'}, {'ForeName': 'Zongke', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthopaedics, West China Hospital, West China School of Medicine, Sichuan University, Chengdu, China.'}]",Annals of translational medicine,['10.21037/atm-20-1793a'] 3505,33842594,Comparison of posterior corneal elevation after SMILE and FS-LASIK in correcting myopia over -9.0 diopters.,"Background To compare the changes in posterior corneal elevation after small incision lenticule extraction (SMILE) and femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK) in correcting myopia over -9 diopters (D). Methods In this prospective comparative study, 82 eyes of 82 patients scheduled for refractive correction were recruited. Eyes were randomly assigned to the SMILE group (45 eyes, -10.43±0.92 D) or FS-LASIK group (37 eyes, -10.97±1.37 D). The posterior corneal surface was measured using a Scheimpflug camera (Pentacam, Oculus, Germany) preoperatively and at 1 day, 1 month, and 6 months after surgery. Posterior corneal elevation in the central point and central 4-mm area, and in various optical zones above the best-fit sphere, was analyzed. A P value of less than 0.05 was considered statistically significant. Results All surgeries were completed successfully. The safety index and efficacy index were 1.20 and 1.00, respectively, in the SMILE group, and was 1.10 and 0.90, respectively, in the FS-LASIK group. No significant difference existed in all analyzed data before and at 6 months after surgery in both the SMILE group and the FS-LASIK group. Changes in posterior corneal elevation after FS-LASIK were greater than after SMILE, with no statistical significance (P≥0.07). In the SMILE group, residual bed thickness was found to be moderately negatively correlated with changes in the elevation in the central area (P≤0.045); whereas it was positively correlated in the peripheral area (P=0.002). Conclusions SMILE and FS-LASIK presented stable posterior corneal surface in correction of myopia over -9.0 D at the follow-up visit of 6 months.",2021,"Changes in posterior corneal elevation after FS-LASIK were greater than after SMILE, with no statistical significance (P≥0.07).",['82 eyes of 82 patients scheduled for refractive correction were recruited'],"['FS-LASIK', 'small incision lenticule extraction (SMILE) and femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK', 'SMILE and FS-LASIK']","['Posterior corneal elevation', 'safety index and efficacy index', 'residual bed thickness', 'posterior corneal surface', 'posterior corneal elevation']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}]","[{'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0752094', 'cui_str': 'Laser assisted in situ keratomileusis'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205148', 'cui_str': 'Surface'}]",82.0,0.0469643,"Changes in posterior corneal elevation after FS-LASIK were greater than after SMILE, with no statistical significance (P≥0.07).","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Ophthalmology and Optometry, Eye and ENT Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Yishan', 'Initials': 'Y', 'LastName': 'Qian', 'Affiliation': 'Department of Ophthalmology and Optometry, Eye and ENT Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Ophthalmology and Optometry, Eye and ENT Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Xueyi', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Ophthalmology and Optometry, Eye and ENT Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Qin', 'Affiliation': 'Department of Ophthalmology and Optometry, Eye and ENT Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Xingtao', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Ophthalmology and Optometry, Eye and ENT Hospital of Fudan University, Shanghai, China.'}]",Annals of translational medicine,['10.21037/atm-20-5165'] 3506,33842592,Personality differences in brain network mechanisms for placebo analgesia and nocebo hyperalgesia in experimental pain: a functional magnetic resonance imaging study.,"Background Placebo and nocebo responses have been increasingly gaining the attention of clinical and scientific researchers. Inconsistent conclusions from current studies indicate that different factors potentially affect both placebo and nocebo responses. Increasing evidence suggests that personality differences may affect the mechanisms of both two responses. In the present work, we explored the characteristics of neural signals of placebo and nocebo responses based on functional connectivity (FC) analysis and Granger causality analysis (GCA). Methods A total of 34 healthy participants received conditional induction training to establish placebo and nocebo responses. Every participant completed the following experimental workflow, including scanning of baseline, experimental low back pain model establishment, scanning of acute pain status, and scanning of placebo response or nocebo response. We collect visual analogue scale (VAS) data after each scanning. Functional magnetic resonance imaging (fMRI) data from different personality groups were subjected to FC analysis and multivariate GCA (mGCA). Results Pain scores for placebo and nocebo responses were statistically different across different personality. There are also statistically differences in the neural signals of two responses across different personality. Conclusions The findings of the present study indicated that extroverted and introverted participants are likely to experience placebo analgesic effects and nocebo hyperalgesia effects, respectively. Both extroverted and introverted participants showed significant changes in brain networks under placebo response. Variation in emotional control and ventromedial prefrontal cortex inactivity may constitute the bulk of the personality differences in placebo analgesia. Differences in the regulation of the sensory conduction system (SCS) and release of the emotional circuit could be important factors affecting personality differences in nocebo hyperalgesia.",2021,Both extroverted and introverted participants showed significant changes in brain networks under placebo response.,"['34 healthy participants', 'experimental pain']","['conditional induction training to establish placebo and nocebo responses', 'Functional magnetic resonance imaging (fMRI', 'placebo analgesia and nocebo hyperalgesia']","['brain networks', 'visual analogue scale (VAS) data', 'Pain scores', 'functional connectivity (FC) analysis and Granger causality analysis (GCA']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesia'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0015127', 'cui_str': 'etiology'}]",34.0,0.249287,Both extroverted and introverted participants showed significant changes in brain networks under placebo response.,"[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Rehabilitation, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Yaping', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': 'Department of Rehabilitation, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Hongrui', 'Initials': 'H', 'LastName': 'Zhan', 'Affiliation': 'Department of Rehabilitation, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Shimin', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Department of Rehabilitation, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Guiyuan', 'Initials': 'G', 'LastName': 'Cai', 'Affiliation': 'Department of Rehabilitation, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Radiology, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Rehabilitation, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}]",Annals of translational medicine,['10.21037/atm-20-5123'] 3507,33842531,Comparison of Clinical Outcomes Between Chinese Patients Receiving Hepatectomy With or Without Enhanced Recovery After Surgery Strategy.,"Purposes: For the first time in China, the current study was designed to compare the clinical outcomes between Chinese patients receiving hepatectomy with or without the enhanced recovery after surgery (ERAS) strategy. Methods: The current study enrolled 250 patients who would receive hepatectomy. Patients were randomized into two groups: ERAS group ( n = 125, ERAS strategy) and control ( n = 125, conventional care). Mortality, length of hospital stay, readmission, and complications were assessed over 30 days after the operation. Results: The average age of the whole cohort was 65 (63-68) years, with 152 males (60.8%). There was no difference between two groups in baseline features, such as age, sex, medical history, Child-Pugh hepatic function, American Society of Anaesthesiologists physical status, operative type, hepatectomy type, and hepatic pathology ( P > 0.05 for all). There was no occurrence of death in the two groups. Patients in the ERAS group had significantly less occurrence of post-operative complications and a shorter length of hospital stay ( P < 0.05 for all). Deep vein thrombosis occurred in seven patients in the control group, but did not occur in the ERAS group ( P < 0.05). Patients in the two groups had similar occurrence of readmission ( P > 0.05). Conclusions: ERAS strategy significantly decreased the occurrence of operative complications and shortened the length of hospital stay without any increase in mortality or readmission in Chinese patients receiving hepatectomy.",2021,Patients in the ERAS group had significantly less occurrence of post-operative complications and a shorter length of hospital stay ( P < 0.05 for all).,"['average age of the whole cohort was 65 (63-68) years, with 152 males (60.8', 'Chinese patients receiving hepatectomy with or without the enhanced recovery after surgery (ERAS) strategy', '250 patients who would receive hepatectomy', 'Chinese Patients Receiving Hepatectomy With or Without Enhanced Recovery', 'Chinese patients receiving hepatectomy']",['ERAS'],"['occurrence of death', 'occurrence of readmission', 'occurrence of post-operative complications', 'Deep vein thrombosis', 'occurrence of operative complications', 'shorter length of hospital stay', 'length of hospital stay', 'mortality or readmission', 'Mortality, length of hospital stay, readmission, and complications']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C2348831', 'cui_str': '250'}]","[{'cui': 'C1521863', 'cui_str': 'estrogen receptor alpha, human'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",250.0,0.0282506,Patients in the ERAS group had significantly less occurrence of post-operative complications and a shorter length of hospital stay ( P < 0.05 for all).,"[{'ForeName': 'Tieli', 'Initials': 'T', 'LastName': 'Kang', 'Affiliation': ""Department of Hepatobiliary Surgery, Inner Mongolia Xing'an Meng People's Hospital, Ulanhot, China.""}, {'ForeName': 'Zhishuo', 'Initials': 'Z', 'LastName': 'Jia', 'Affiliation': ""Department of Hepatobiliary Surgery, Inner Mongolia Xing'an Meng People's Hospital, Ulanhot, China.""}, {'ForeName': 'Guoquan', 'Initials': 'G', 'LastName': 'Xing', 'Affiliation': ""Department of Hepatobiliary Surgery, Inner Mongolia Xing'an Meng People's Hospital, Ulanhot, China.""}, {'ForeName': 'Quanhe', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': ""Department of Hepatobiliary Surgery, Inner Mongolia Xing'an Meng People's Hospital, Ulanhot, China.""}]",Frontiers in surgery,['10.3389/fsurg.2021.645935'] 3508,33851953,Effect of Dapagliflozin on Cardiovascular Outcomes According to Baseline Kidney Function and Albuminuria Status in Patients With Type 2 Diabetes: A Prespecified Secondary Analysis of a Randomized Clinical Trial.,"Importance Sodium-glucose cotransporter 2 inhibitors, such as dapagliflozin, promote renal glucose excretion and reduce cardiovascular (CV) deaths and hospitalizations for heart failure (HHF) among patients with type 2 diabetes. The relative CV efficacy and safety of dapagliflozin according to baseline kidney function and albuminuria status are unknown. Objective To assess the CV efficacy and safety of dapagliflozin according to baseline estimated glomerular filtration rate (eGFR) and urinary albumin to creatinine ratio (UACR). Design, Setting, and Participants This secondary analysis of the randomized clinical trial Dapagliflozin Effect on Cardiovascular Events-Thrombolysis in Myocardial Infarction 58 compared dapagliflozin vs placebo in 17 160 patients with type 2 diabetes and a baseline creatinine clearance of 60 mL/min or higher. Patients were categorized according to prespecified subgroups of baseline eGFR (<60 vs ≥60 mL/min/1.73 m2), urinary albumin to creatinine ratio (UACR; <30 vs ≥30 mg/g), and of chronic kidney disease (CKD) markers using these subgroups (0, 1, or 2). The study was conducted from May 2013 to September 2018. Interventions Dapagliflozin vs placebo. Main Outcomes and Measures The dual primary end points were major adverse cardiovascular events (myocardial infarction, stroke, and CV death) and the composite of CV death or HHF. Results At baseline, 1265 patients (7.4%) had an eGFR below 60 mL/min/1.73 m2, and 5199 patients (30.9%) had albuminuria. Among patients having data for both eGFR and UACR, 10 958 patients (65.1%) had an eGFR equal to or higher than 60 mL/min/1.73 m2 and an UACR below 30 mg/g (mean [SD] age, 63.7 [6.7] years; 40.1% women), 5336 patients (31.7%) had either an eGFR below 60 mL/min/1.73 m2 or albuminuria (mean [SD] age, 64.1 [7.1] years; 32.6% women), and 548 patients (3.3%) had both (mean [SD] age, 66.8 [6.9] years; 30.5% women). In the placebo group, patients with more CKD markers had higher event rates at 4 years as assessed using the Kaplan-Meier approach for the composite of CV death or HHF (3.9% for 0 markers, 8.3% for 1 marker, and 17.4% for 2 markers) and major adverse cardiovascular events (7.5% for 0 markers, 11.6% for 1 marker, and 18.9% for 2 markers). Estimates for relative risk reductions for the composite of CV death or HHF and for major adverse cardiovascular events were generally consistent across subgroups (both P > .24 for interaction), although greater absolute risk reductions were observed with more markers of CKD. The absolute risk difference for the composite of CV death or HHF was greater for patients with more markers of CKD (0 markers, -0.5%; 1 marker, -1.0%; and 2 markers, -8.3%; P = .02 for interaction). The numbers of amputations, cases of diabetic ketoacidosis, fractures, and major hypoglycemic events were balanced or numerically lower with dapagliflozin compared with placebo for patients with an eGFR below 60 mL/min/1.73 m2 and an UACR of 30 mg/g or higher. Conclusions and Relevance The effect of dapagliflozin on the relative risk for CV events was consistent across eGFR and UACR groups, with the greatest absolute benefit for the composite of CV death or HHF observed among patients with both reduced eGFR and albuminuria. Trial Registration ClinicalTrials.gov Identifier: NCT01730534.",2021,"Estimates for relative risk reductions for the composite of CV death or HHF and for major adverse cardiovascular events were generally consistent across subgroups (both P > .24 for interaction), although greater absolute risk reductions were observed with more markers of CKD.","['Patients With Type 2 Diabetes', 'Patients were categorized according to prespecified subgroups of baseline eGFR (<60 vs ≥60 mL/min/1.73 m2), urinary albumin to creatinine ratio (UACR; <30 vs ≥30 mg/g), and of chronic kidney disease (CKD) markers using these subgroups (0, 1, or 2', '17\u202f160 patients with type 2 diabetes and a baseline creatinine clearance of 60 mL/min or higher', 'patients with type 2 diabetes', 'May 2013 to September 2018', 'patients having data for both eGFR and UACR, 10\u202f958 patients (65.1%) had an eGFR equal to or higher than 60 mL/min/1.73 m2 and an UACR below 30 mg/g (mean [SD] age, 63.7 [6.7] years; 40.1% women), 5336 patients (31.7%) had either an eGFR below 60 mL/min/1.73 m2 or albuminuria (mean [SD] age, 64.1 [7.1] years; 32.6% women), and 548 patients (3.3%) had both (mean [SD] age, 66.8 [6.9] years; 30.5% women']","['Dapagliflozin vs placebo', 'dapagliflozin', 'placebo', 'Dapagliflozin', 'dapagliflozin vs placebo']","['CV efficacy and safety', 'Cardiovascular Outcomes', 'renal glucose excretion and reduce cardiovascular (CV) deaths and hospitalizations for heart failure (HHF', 'event rates', 'major adverse cardiovascular events', 'numbers of amputations, cases of diabetic ketoacidosis, fractures, and major hypoglycemic events', 'albuminuria', 'Cardiovascular Events-Thrombolysis', 'absolute risk reductions', 'composite of CV death or HHF', 'CV death or HHF', 'major adverse cardiovascular events (myocardial infarction, stroke, and CV death) and the composite of CV death or HHF', 'relative CV efficacy and safety', 'relative risk for CV events', 'glomerular filtration rate (eGFR) and urinary albumin to creatinine ratio (UACR', 'CV death or HHF and for major adverse cardiovascular events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4708784', 'cui_str': '31.7'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C4517688', 'cui_str': '3.3'}, {'cui': 'C4517844', 'cui_str': '66.8'}, {'cui': 'C4517826', 'cui_str': '6.9'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",17160.0,0.576842,"Estimates for relative risk reductions for the composite of CV death or HHF and for major adverse cardiovascular events were generally consistent across subgroups (both P > .24 for interaction), although greater absolute risk reductions were observed with more markers of CKD.","[{'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Zelniker', 'Affiliation': 'Department of Cardiology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Itamar', 'Initials': 'I', 'LastName': 'Raz', 'Affiliation': 'The Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, The Faculty of Medicine, Jerusalem, Israel.'}, {'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'The Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, The Faculty of Medicine, Jerusalem, Israel.'}, {'ForeName': 'Jamie P', 'Initials': 'JP', 'LastName': 'Dwyer', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Hiddo H J L', 'Initials': 'HHJL', 'LastName': 'Heerspink', 'Affiliation': 'University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Avivit', 'Initials': 'A', 'LastName': 'Cahn', 'Affiliation': 'The Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, The Faculty of Medicine, Jerusalem, Israel.'}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Goodrich', 'Affiliation': 'The Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, The Faculty of Medicine, Jerusalem, Israel.'}, {'ForeName': 'Kyungah', 'Initials': 'K', 'LastName': 'Im', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Ontario, Canada.""}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'Division of Cardiology, The University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'John P H', 'Initials': 'JPH', 'LastName': 'Wilding', 'Affiliation': 'Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Gause-Nilsson', 'Affiliation': 'BioPharmaceuticals Research & Development, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'BioPharmaceuticals Research & Development, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}]",JAMA cardiology,['10.1001/jamacardio.2021.0660'] 3509,33851923,Feasibility and Acceptability of a Smoking Cessation Smartphone App (My QuitBuddy) in Older Persons: Pilot Randomized Controlled Trial.,"BACKGROUND Although many smoking cessation smartphone apps exist, few have been independently evaluated, particularly in older populations. In 2017, of the 112 commercially available smoking cessation apps in Australia, only 6 were deemed to be of high quality, in that they partially adhered to Australian guidelines. Mobile health (mHealth) apps have the potential to modify smoking behavior at a relatively low cost; however, their acceptability in older smokers remains unknown. Rigorous scientific evaluation of apps is thus urgently needed to assist smokers and clinicians alike. OBJECTIVE We conducted a pilot randomized controlled trial to evaluate the feasibility of a large-scale trial to assess the use and acceptability of a high-quality smoking cessation app in older smokers. METHODS Adult inpatient and outpatient smokers with computer and smartphone access were recruited face to face and via telephone interviews from Metropolitan Hospitals in Brisbane, Australia. Participants were randomized 1:1 to the intervention (requested to download the ""My QuitBuddy"" smoking cessation app on their smartphone) or the control group (provided access to a tailored smoking cessation support webpage [Quit HQ]). The My QuitBuddy app is freely available from app stores and provides personalized evidenced-based smoking cessation support. Quit HQ offers regular email support over 12 weeks. No training or instructions on the use of these e-resources were given to participants. Outcomes at 3 months included recruitment and retention rates, use and acceptability of e-resource (User Version of the Mobile App Rating Scale [uMARS]), changes in quitting motivation (10-point scale), and self-reported smoking abstinence. RESULTS We randomized 64 of 231 potentially eligible individuals (27.7%). The mean age of participants was 62 (SD 8). Nicotine dependence was moderate (mean Heaviness of Smoking Index [HSI] 2.8 [SD 1.2]). At 3 months the retention rate was (58/64, 91%). A total of 15 of 31 participants in the intervention arm (48%) used the app at least once, compared with 10 of 33 (30%) in the control arm. uMARS scores for e-resource use and acceptability were statistically similar (P=.29). Motivation to quit was significantly higher in the intervention arm compared with the control arm (median 6 [IQR 4-8] versus 4 [IQR 4-5], respectively, P=.02). According to the intention-to-treat analysis, smoking abstinence was nonsignificantly higher in the intervention group (4/31 [13%], 95% CI 4%-30%, versus 2/33 [6%], 95% CI 1%-20%; P=.42). The estimated number needed to treat was 14. CONCLUSIONS Internet and mHealth smoking cessation resources appear acceptable to a minority of older smokers. Smokers who engaged with the allocated e-resources rated them equally, and there were trends toward greater uptake, increased motivation, and higher abstinence rates in the app group; however, only the change in motivation reached statistical significance (median score 6 versus 4, respectively, P=.02). This results of this pilot study suggest that apps may improve quit outcomes in older adults who are willing to use them. Further research into user-app interactions should be undertaken to facilitate improvements in app design and consumer engagement. These favorable trends should be explored in larger trials with sufficient statistical power. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry ACTRN12619000159156; http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376849&isReview=true.",2021,"Outcomes at 3 months included recruitment and retention rates, use and acceptability of e-resource (User Version of the Mobile App Rating Scale [uMARS]), changes in quitting motivation (10-point scale), and self-reported smoking abstinence. ","['older smokers', 'Older Persons', 'older adults who are willing to use them', 'Adult inpatient and outpatient smokers with computer and smartphone access were recruited face to face and via telephone interviews from Metropolitan Hospitals in Brisbane, Australia', '231 potentially eligible individuals (27.7']","['Smoking Cessation Smartphone App (My QuitBuddy', 'intervention (requested to download the ""My QuitBuddy"" smoking cessation app on their smartphone) or the control group (provided access to a tailored smoking cessation support webpage [Quit HQ']","['abstinence rates', 'recruitment and retention rates, use and acceptability of e-resource (User Version of the Mobile App Rating Scale [uMARS]), changes in quitting motivation (10-point scale), and self-reported smoking abstinence', 'Motivation to quit', 'Nicotine dependence was moderate (mean Heaviness of Smoking Index', 'quit outcomes', 'uMARS scores for e-resource use and acceptability', 'retention rate', 'smoking abstinence']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C0020029', 'cui_str': 'Urban Hospitals'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0028043', 'cui_str': 'Nicotine dependence'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",64.0,0.105107,"Outcomes at 3 months included recruitment and retention rates, use and acceptability of e-resource (User Version of the Mobile App Rating Scale [uMARS]), changes in quitting motivation (10-point scale), and self-reported smoking abstinence. ","[{'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Peek', 'Affiliation': 'The University of Queensland Thoracic Research Centre, The Prince Charles Hospital, Chermside, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hay', 'Affiliation': 'QIMR Berghoffer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Hughes', 'Affiliation': 'The Department of Respiratory Medicine, Redcliffe Hospital, Redcliffe, Australia.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Kostellar', 'Affiliation': ""The Pharmacy Department, The Royal Brisbane and Women's Hospital, Brisbane, Australia.""}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'The Department of Respiratory Medicine, Redcliffe Hospital, Redcliffe, Australia.'}, {'ForeName': 'Zaheerodin', 'Initials': 'Z', 'LastName': 'Bhikoo', 'Affiliation': 'The Department of Respiratory Medicine, Caboolture Hospital, Caboolture, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Serginson', 'Affiliation': 'The Department of Respiratory Medicine, Caboolture Hospital, Caboolture, Australia.'}, {'ForeName': 'Henry M', 'Initials': 'HM', 'LastName': 'Marshall', 'Affiliation': 'The University of Queensland Thoracic Research Centre, The Prince Charles Hospital, Chermside, Australia.'}]",JMIR formative research,['10.2196/24976'] 3510,33851905,Prospective Randomized Study Evaluating the Effects of Preoperative Opioid Counseling on Postoperative Opioid Use after Outpatient Lower Extremity Orthopaedic Surgery.,"The objective of this study was to investigate the effect of standardized preoperative opioid counseling on postoperative opioid consumption for patients undergoing outpatient lower extremity orthopaedic surgery. Participating patients undergoing elective outpatient lower extremity orthopaedic surgery were randomized to either receive preoperative opioid counseling or not receive counseling (control group). Counseling was delivered via a five-minute pre-recorded standardized video preoperatively. Postoperatively, patients in both groups were queried for their postoperative pain experience, opioid consumption, non-opioid medication consumption, and any adverse effects related to their pain management experience. A total of 107 patients were studied, with 45 in the counseling group and 62 in the control group. Patients that received preoperative opioid counseling consumed on average 6.5 opioid pills postoperatively; the control group consumed 12.4 opioid pills (p = 0.008). Preoperative opioid counseling resulted in a statistically significant reduction in postoperative opioid consumption after outpatient lower extremity orthopaedic surgery. (Journal of Surgical Orthopaedic Advances 30(1):002-006, 2021).",2021,Preoperative opioid counseling resulted in a statistically significant reduction in postoperative opioid consumption after outpatient lower extremity orthopaedic surgery.,"['107 patients were studied, with 45 in the counseling group and 62 in the control group', 'Outpatient Lower Extremity Orthopaedic Surgery', 'patients undergoing outpatient lower extremity orthopaedic surgery', 'Participating patients undergoing elective outpatient lower extremity orthopaedic surgery']","['Preoperative Opioid Counseling', 'Preoperative opioid counseling', 'preoperative opioid counseling', 'preoperative opioid counseling or not receive counseling (control group', 'standardized preoperative opioid counseling']","['postoperative opioid consumption', 'Postoperative Opioid Use', 'postoperative pain experience, opioid consumption, non-opioid medication consumption']","[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0237547', 'cui_str': 'Group counseling'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",107.0,0.0301077,Preoperative opioid counseling resulted in a statistically significant reduction in postoperative opioid consumption after outpatient lower extremity orthopaedic surgery.,"[{'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Paskey', 'Affiliation': 'From Rothman Institute at Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Sage', 'Initials': 'S', 'LastName': 'Vincent', 'Affiliation': 'From Rothman Institute at Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Critchlow', 'Affiliation': 'From Rothman Institute at Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Mann', 'Affiliation': 'From Rothman Institute at Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Talia', 'Initials': 'T', 'LastName': 'Chapman', 'Affiliation': 'From Rothman Institute at Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Aland', 'Affiliation': 'From Rothman Institute at Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Dodson', 'Affiliation': 'From Rothman Institute at Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Emper', 'Affiliation': 'From Rothman Institute at Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Kevin B', 'Initials': 'KB', 'LastName': 'Freedman', 'Affiliation': 'From Rothman Institute at Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pedowitz', 'Affiliation': 'From Rothman Institute at Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Asif M', 'Initials': 'AM', 'LastName': 'Ilyas', 'Affiliation': 'From Rothman Institute at Thomas Jefferson University, Philadelphia, Pennsylvania.'}]",Journal of surgical orthopaedic advances,[] 3511,33851765,"The stability of implants and microbiological effects following photobiomodulation therapy with one-stage placement: A randomized, controlled, single-blinded, and split-mouth clinical study.","BACKGROUND Studies have reported a positive effect on bone healing and the elimination of microorganisms placed on the titanium implants, while others have not confirmed the positive photobiomodulation therapy (PBMT) effects on bone regeneration and bone structure around the implants. PURPOSE The aim of the present study was to address the following questions: Does PBMT improve implant stability and affect microbiota around dental implants in the early stage of osseointegration? MATERIALS AND METHODS This study was designed as randomized-controlled prospective, split mouth, single-blinded clinical trial. Implants were randomly divided into two groups and implants placed in the test group were treated with Gallium-aluminum-arsenide (GaAlAs) diode laser with PBMT immediately after surgery and for 15 days (n = 47). In the control group, implants were not irradiated(n = 46). The primary stability of the implants was measured by the Resonance frequency analysis (RFA) after insertion and the secondary stability values were recorded at 30th, 60th, and 90th days after surgery as implant stability quotient (ISQ). The hand-held RFA was held perpendicular to the jaw line as indicated by the manufacturer for buccal-lingual (BL), mesial-distal (MD), and lingual-buccal (LB) measurement and different measurements were analyzed as separately. RESULTS Significantly higher magnetic RFA values were achieved on the 90th day in all measurement sides for both groups. ISQ levels in groups at baseline and the day-30, 60, and 90. ISQ readings were not statistically significant between test and control groups for each time point. A statistically significant increase in ISQ reading for BL, MD, and LB dimensions in both groups was noted from baseline to the day-90 (P < .05). CONCLUSION It was concluded that PBMT did not have a clinically significant effect on implant stabilization, especially in terms of ISQ values at early alveolar bone healing term. Clinical trial number is NCT04495335.",2021,"A statistically significant increase in ISQ reading for BL, MD, and LB dimensions in both groups was noted from baseline to the day-90 (P < .05). ",[],"['Gallium-aluminum-arsenide (GaAlAs) diode laser with PBMT', 'PBMT', 'photobiomodulation therapy with one-stage placement']","['ISQ values', 'implant stability quotient (ISQ', 'ISQ levels', 'ISQ reading for BL, MD, and LB dimensions', 'magnetic RFA values', 'ISQ readings', 'Resonance frequency analysis (RFA) after insertion and the secondary stability values', 'stability of implants and microbiological effects']",[],"[{'cui': 'C0016980', 'cui_str': 'Gallium'}, {'cui': 'C0002367', 'cui_str': 'Aluminum'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4505213', 'cui_str': 'Resonance Frequency Analysis'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.108937,"A statistically significant increase in ISQ reading for BL, MD, and LB dimensions in both groups was noted from baseline to the day-90 (P < .05). ","[{'ForeName': 'Suleyman', 'Initials': 'S', 'LastName': 'Bozkaya', 'Affiliation': 'Faculty of Dentistry, Department of Oral and Maxillofacial Surgery, Gazi University, Ankara, Turkey.'}, {'ForeName': 'Ahu', 'Initials': 'A', 'LastName': 'Uraz', 'Affiliation': 'Faculty of Dentistry, Department of Periodontology, Gazi University, Ankara, Turkey.'}, {'ForeName': 'Berceste', 'Initials': 'B', 'LastName': 'Guler', 'Affiliation': 'Faculty of Dentistry, Department of Periodontology, Kütahya Health Science University, Kütahya, Turkey.'}, {'ForeName': 'Sevil Altundağ', 'Initials': 'SA', 'LastName': 'Kahraman', 'Affiliation': 'Faculty of Dentistry, Department of Oral and Maxillofacial Surgery, Gazi University, Ankara, Turkey.'}, {'ForeName': 'Bilge', 'Initials': 'B', 'LastName': 'Turhan Bal', 'Affiliation': 'Faculty of Dentistry, Department of Prosthetic Restorative Dentistry, Gazi University, Ankara, Turkey.'}]",Clinical implant dentistry and related research,['10.1111/cid.12999'] 3512,33851734,Mindfulness and acceptance-based behavioral treatment for bulimia-spectrum disorders: A pilot feasibility randomized trial.,"OBJECTIVE Although existing research supports the efficacy of mindfulness- and acceptance-based treatments (MABTs) for eating disorders (EDs), few studies have directly compared outcomes from MABTs to standard CBT. METHOD Participants (N = 44), treatment-seeking adults with bulimia-spectrum EDs, were screened for eligibility, consented, and randomized to receive 20 sessions of outpatient, individual CBT or MABT treatment. Treatment outcomes (binge eating and compensatory behavior episodes, global ED severity, depressive symptoms, quality of life, emotional awareness/clarity, distress tolerance, values-based decision-making, and emotion modulation) were measured at pre-treatment, post-treatment, and 6-month follow up. Data on feasibility and acceptability are also presented. RESULTS Treatment and assessment retention rates were comparable between MABT and CBT (p range = .51-.73) and between-group differences on acceptability measures were very small (d range = 0.03-0.19). Both conditions produced notable and generally comparable changes in most treatment outcomes at post-treatment (within group d range = 0.06-1.77). DISCUSSION The MABT and CBT conditions demonstrated comparable degrees of feasibility, acceptability, and symptom improvement, suggesting that MABTs warrant further evaluation as ED treatments.",2021,"RESULTS Treatment and assessment retention rates were comparable between MABT and CBT (p range = .51-.73) and between-group differences on acceptability measures were very small (d range = 0.03-0.19).","['bulimia-spectrum disorders', 'Participants (N = 44), treatment-seeking adults with bulimia-spectrum EDs']","['Mindfulness and acceptance-based behavioral treatment', 'individual CBT or MABT treatment']","['feasibility, acceptability, and symptom improvement', 'Treatment outcomes (binge eating and compensatory behavior episodes, global ED severity, depressive symptoms, quality of life, emotional awareness/clarity, distress tolerance, values-based decision-making, and emotion modulation', 'assessment retention rates', 'feasibility and acceptability', 'acceptability measures']","[{'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0013720', 'cui_str': 'Ehlers-Danlos syndrome'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property)'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",44.0,0.0506646,"RESULTS Treatment and assessment retention rates were comparable between MABT and CBT (p range = .51-.73) and between-group differences on acceptability measures were very small (d range = 0.03-0.19).","[{'ForeName': 'Adrienne S', 'Initials': 'AS', 'LastName': 'Juarascio', 'Affiliation': 'Department of Psychology, Drexel University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Megan N', 'Initials': 'MN', 'LastName': 'Parker', 'Affiliation': 'Department of Medical and Clinical Psychology, Uniformed Services University of the Health Sciences (USU), Bethesda, Maryland, USA.'}, {'ForeName': 'Rowan', 'Initials': 'R', 'LastName': 'Hunt', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Louisville, Louisville, Kentucky, USA.'}, {'ForeName': 'Helen Burton', 'Initials': 'HB', 'LastName': 'Murray', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Emily K', 'Initials': 'EK', 'LastName': 'Presseller', 'Affiliation': 'Department of Psychology, Drexel University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Manasse', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Science, Drexel University, Philadelphia, Pennsylvania, USA.'}]",The International journal of eating disorders,['10.1002/eat.23512'] 3513,33851684,Resistance training exercises for obese and non-obese individuals living in high-altitude regions utilizing biochemical markers-A controlled trial.,"Background High-altitude disease prevalence varies according to types of exposure and the effects of hypoxic and hypobaric environments, with the result that people at high altitudes present many different physiological responses. Aims The research aims to analyze the effects of resistance training (RT) exercises at high altitudes on obese subjects and to explain the determinants that make obese people more susceptible to various chronic illnesses such as diabetes mellitus, hypertension, asthma, etc. Methods This study recruited 225 subjects living in the high-altitude region of Aseer, Saudi Arabia, and divided them into three groups. The first two groups consisted of obese people, out of which one group received RT and one did not. The third group consisted of average-weight individuals, according to their BMI, who received RT. Biochemical parameters were checked for all three groups before commencing with the RT and at the 4 th and 8 th week to measure the effects of the exercise. Results Mean and standard deviations of the demographic variables: age was 34.2 ± 8.9 years, weight was 69.3 ± 8.5 kg, and height was 1.6 ± 0.06 meters. RT had a significant effect on the total levels of cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol, adiponectin, interleukin-6, and testosterone. Post-hoc comparisons using the Fisher's Least Significant Difference test indicated that the mean scores between the groups differed significantly. Conclusion Our findings show that RT would be a useful and practical substitute to improve the health status of obese patients. It helps to decrease body fat and to improve lipid profiles and hormonal control.",2021,"RT had a significant effect on the total levels of cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol, adiponectin, interleukin-6, and testosterone.","['obese and non-obese individuals living in high-altitude regions', '225 subjects living in the high-altitude region of Aseer, Saudi Arabia, and divided them into three groups', 'obese patients', 'Mean and standard deviations of the demographic variables: age was 34.2 ± 8.9 years, weight was 69.3 ± 8.5 kg, and height was 1.6 ± 0.06 meters', 'obese subjects']","['Resistance training exercises', 'resistance training (RT) exercises', 'RT']","['lipid profiles and hormonal control', 'mean scores', 'total levels of cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol, adiponectin, interleukin-6, and testosterone']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0238617', 'cui_str': 'High altitude'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191359', 'cui_str': '34.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C4517412', 'cui_str': '0.06'}, {'cui': 'C0441074', 'cui_str': 'Meters'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}]",225.0,0.00859253,"RT had a significant effect on the total levels of cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol, adiponectin, interleukin-6, and testosterone.","[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Ahmad', 'Affiliation': 'Department of Medical Rehabilitation Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Saudi Arabia.'}, {'ForeName': 'G S', 'Initials': 'GS', 'LastName': 'Zaman', 'Affiliation': 'Clinical Laboratory Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Saudi Arabia.'}, {'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Silvian', 'Affiliation': 'Medical Rehabilitation Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Saudi Arabia.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Alshaharani', 'Affiliation': 'Medical Rehabilitation Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Saudi Arabia.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Ahmad', 'Affiliation': 'Clinical Laboratory Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Saudi Arabia.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Mansuri', 'Affiliation': 'Department of Microbiology, Hopkins Medical Laboratory and Research, New Delhi, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Fayazuddin', 'Affiliation': 'Department of Pharmacognosy, College of Pharmacy, King Khalid University, Abha, Saudi Arabia.'}]",Nigerian journal of clinical practice,['10.4103/njcp.njcp_277_19'] 3514,33851682,Comparison of the treatment outcomes of the conventional stainless steel crown restorations and the hall technique in the treatment of carious primary molars.,"Background Dental caries is a multifactorial disease that causes reversible decalcification and cavitation of susceptible teeth exposed to sugary substrates over a period of time in the oral cavity. It gives clinical and social burdens to the child patients and their parents/carers. Stainless steel crown (SSC) restoration is one of the restorative treatment options in the management of carious primary molars. Aims The Hall technique is a biologic method of managing primary teeth by sealing in the caries with preformed metal crowns (SSCs). The objectives of this study were to assess and compare the primary and secondary treatment outcomes of stainless steel crown restorations using the conventional method and the Hall technique in primary molars immediately after placement and over a 12-month period using both clinical and radiological parameters. Methods The study was a randomized control clinical trial using a split mouth approach. A total of 25 stainless steel crown restorations using the conventional method and 25 stainless steel crown restorations using the Hall technique were placed in 25 subjects aged 3-8 years with a pair or pairs of unrestored enamel or dentinal carious primary molars matched for tooth type, dental arch, and extent of caries. All subjects were monitored and reviewed every 3 months for 12 months. Results Twenty three subjects returned for follow-up. There was no statistically significant difference (P-value > 0.05) between the conventional SSC restoration and the Hall technique for both the primary outcomes/major failures (irreversible pulpitis, dental abscess, peri-radicular radiolucency, and crown loss with tooth unrestorable) and secondary outcomes/minor failures (crown loss and tooth restorable, crown perforation, secondary/marginal caries, and reversible pulpitis). But, there was a statistical significant difference in the average time taken for the placement of the restorations between the two groups (P-value 0.001). Conclusion Both the conventional SSC restorations and the Hall technique can be provided for all the subjects in this study. The Hall Technique compared favorably well with the conventional SSC restoration in clinical and radiological outcomes. The Hall Technique appears to offer an effective treatment option for managing dental caries in primary molar teeth especially in a resource challenged environment where electricity and treatment under general aaesthesia can sometimes be a problem.",2021,"There was no statistically significant difference (P-value > 0.05) between the conventional SSC restoration and the Hall technique for both the primary outcomes/major failures (irreversible pulpitis, dental abscess, peri-radicular radiolucency, and crown loss with tooth unrestorable) and secondary outcomes/minor failures (crown loss and tooth restorable, crown perforation, secondary/marginal caries, and reversible pulpitis).","['caries with preformed metal crowns (SSCs', '25 stainless steel crown restorations using the conventional method and 25 stainless steel crown restorations using the Hall technique were placed in 25 subjects aged 3-8 years with a pair or pairs of unrestored enamel or dentinal carious primary molars matched for tooth type, dental arch, and extent of caries', 'carious primary molars']","['conventional stainless steel crown restorations', 'stainless steel crown restorations', 'Stainless steel crown (SSC) restoration']","['major failures (irreversible pulpitis, dental abscess, peri-radicular radiolucency, and crown loss with tooth unrestorable) and secondary outcomes/minor failures (crown loss and tooth restorable, crown perforation, secondary/marginal caries, and reversible pulpitis', 'average time taken']","[{'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0038126', 'cui_str': 'Stainless steel material'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011325', 'cui_str': 'Dental arch structure'}, {'cui': 'C0439792', 'cui_str': 'Extent'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038126', 'cui_str': 'Stainless steel material'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0518988', 'cui_str': 'Dental abscess'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}]",25.0,0.0399769,"There was no statistically significant difference (P-value > 0.05) between the conventional SSC restoration and the Hall technique for both the primary outcomes/major failures (irreversible pulpitis, dental abscess, peri-radicular radiolucency, and crown loss with tooth unrestorable) and secondary outcomes/minor failures (crown loss and tooth restorable, crown perforation, secondary/marginal caries, and reversible pulpitis).","[{'ForeName': 'O S', 'Initials': 'OS', 'LastName': 'Ayedun', 'Affiliation': 'Department of Child Dental Health, College of Medicine, University of Lagos, Nigeria.'}, {'ForeName': 'F A', 'Initials': 'FA', 'LastName': 'Oredugba', 'Affiliation': 'Department of Child Dental Health, College of Medicine, University of Lagos, Nigeria.'}, {'ForeName': 'E O', 'Initials': 'EO', 'LastName': 'Sote', 'Affiliation': 'Department of Child Dental Health, College of Medicine, University of Lagos, Nigeria.'}]",Nigerian journal of clinical practice,['10.4103/njcp.njcp_460_20'] 3515,33851671,Effect of ferrule height and distribution on the fracture resistance of endodontically treated premolars.,"Objective To evaluate the effect of varying ferrule height and distribution on the fatigue resistance and fracture strength of endodontically treated premolars. Materials and Method Thirty-two extracted human premolars were endodontically treated and prepared to receive all-ceramic crowns. Teeth were randomly divided into two groups. The occluso-cervical height was reduced to 2 mm and 4 mm for the 1 st and 2 nd groups, respectively. According to the ferrule distribution, samples in each group were randomly divided into two subgroups with inadequate ferrule on 1 or 2 proximal walls, respectively. Coronal tooth structure was built-up to 4 mm using a core build-up material retained by a fiber post. The CEREC system (Sirona) was used to design and mill lithium-disilicate crowns. All posts and crowns were cemented to their respective teeth using self-adhesive universal resin cement. All crowns were subjected to cyclic loading in a universal testing machine (Instron) (20-100N, 100,000 cycles, 20Hz). After fatigue, crowns were loaded to fracture. Fracture load data were analyzed using two-way ANOVA at α = 0.05. Results All crowns passed the fatigue testing without any signs of fracture or crack. Two-way ANOVA revealed a statistically significant effect of the number of missing walls (P < 0.05) on the fracture load, but not the ferrule height or the interaction terms. Samples with one missing wall showed higher fracture load in comparison to samples with two missing walls. Conclusion The number of missing walls, not the ferrule height, has a significant effect on the fracture load of the lithium-disilicate crowns restoring endodontically treated premolars.",2021,"The occluso-cervical height was reduced to 2 mm and 4 mm for the 1 st and 2 nd groups, respectively.","['endodontically treated premolars', 'Materials and Method\n\n\nThirty-two extracted human premolars were endodontically treated and prepared to receive all-ceramic crowns']",[],"['occluso-cervical height', 'Fracture load data', 'fracture resistance', 'fatigue resistance and fracture strength', 'fracture load', 'number of missing walls']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0440171', 'cui_str': 'Dental ceramic crown material'}]",[],"[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C4704755', 'cui_str': 'Fracture Strength'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205380', 'cui_str': 'Walled'}]",,0.0259665,"The occluso-cervical height was reduced to 2 mm and 4 mm for the 1 st and 2 nd groups, respectively.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zahran', 'Affiliation': 'Department of Oral and Maxillofacial Prosthodontics, Faculty of Dentistry, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Abderbwih', 'Affiliation': 'Department of Oral Diagnostic Sciences, Faculty of Dentistry, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Mandourah', 'Affiliation': 'Department of Oral and Maxillofacial Prosthodontics, Faculty of Dentistry, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Afif', 'Affiliation': 'General Dentist, International Medical Center, Jeddah, Saudi Arabia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Sabbahi', 'Affiliation': 'Department of Dental Public Health, Faculty of Dentistry, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Merdad', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Sonbul', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dentistry, King Abdulaziz University, Jeddah, Saudi Arabia.'}]",Nigerian journal of clinical practice,['10.4103/njcp.njcp_268_20'] 3516,33851591,ACUTE ISCHEMIC STROKE IN WOMEN: EFFICACY OF THE FREE RADICAL SCAVENGER EDARAVONE.,"OBJECTIVE The aim: To investigate the effectiveness of usage of the free radical scavenger Edaravone in the therapy of women with AIS. PATIENTS AND METHODS Materials and methods: A prospective study was conducted of 48 women with AIS, divided into two groups. Patients in the first group (n = 36) were treated with edaravone 30 mg twice a day intravenously. Neuroprotectors were not used in the control group (n = 12). Clinical-instrumental and neurological examination (Glasgow scale (SCG), FOUR, NIHSS, and neuronspecific enolase (NSE) levels) were performed on all patients. RESULTS Results: The mean FOUR score in the 1th group increased from 11.04±0.85 to 15.47±0.63 points against 11.39±0.56 to 13.46±1.49 in the control group (pp<0.05). The level of NSE in control group patients increased 10-fold (from 9.2 to 96.4 ng/ml, p<0.01). Subsequently, there was a rapid decrease in NSE level in 1th group, and in the control group until 10 days of treatment, the level of NSE did not reach the reference values (p p<0.05). CONCLUSION Conclusions: The introduction of edaravone in women with AIS results in positive results already in the acute period of the disease. The use of edaravon was significantly effective on the FOUR scale and the dynamics of NSE levels.",2021,"The level of NSE in control group patients increased 10-fold (from 9.2 to 96.4 ng/ml, p<0.01).","['women with AIS', '48 women with AIS, divided into two groups']","['edaravone', 'free radical scavenger Edaravone']","['mean FOUR score', 'NSE level', 'FOUR scale and the dynamics of NSE levels', 'Clinical-instrumental and neurological examination (Glasgow scale (SCG), FOUR, NIHSS, and neuronspecific enolase (NSE) levels', 'level of NSE']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039585', 'cui_str': 'Androgen resistance syndrome'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0070694', 'cui_str': 'edaravone'}, {'cui': 'C0079381', 'cui_str': 'Free Radical Scavengers'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0202144', 'cui_str': 'Neuron-specific enolase measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0031691', 'cui_str': 'Enolase'}]",48.0,0.0248164,"The level of NSE in control group patients increased 10-fold (from 9.2 to 96.4 ng/ml, p<0.01).","[{'ForeName': 'Yuriy P', 'Initials': 'YP', 'LastName': 'Vdovychenko', 'Affiliation': 'SHUPYK NATIONAL MEDICAL ACADEMY OF POSTGRADUATE EDUCATION, KYIV, UKRAINE.'}, {'ForeName': 'Oleg A', 'Initials': 'OA', 'LastName': 'Loskutov', 'Affiliation': 'SHUPYK NATIONAL MEDICAL ACADEMY OF POSTGRADUATE EDUCATION, KYIV, UKRAINE.'}, {'ForeName': 'Oleksandr A', 'Initials': 'OA', 'LastName': 'Halushko', 'Affiliation': 'SHUPYK NATIONAL MEDICAL ACADEMY OF POSTGRADUATE EDUCATION, KYIV, UKRAINE.'}, {'ForeName': 'Maryna A', 'Initials': 'MA', 'LastName': 'Trishchynska', 'Affiliation': 'SHUPYK NATIONAL MEDICAL ACADEMY OF POSTGRADUATE EDUCATION, KYIV, UKRAINE.'}, {'ForeName': 'Dmytro O', 'Initials': 'DO', 'LastName': 'Dziuba', 'Affiliation': 'SHUPYK NATIONAL MEDICAL ACADEMY OF POSTGRADUATE EDUCATION, KYIV, UKRAINE.'}, {'ForeName': 'Tetiana M', 'Initials': 'TM', 'LastName': 'Povietkina', 'Affiliation': 'SHUPYK NATIONAL MEDICAL ACADEMY OF POSTGRADUATE EDUCATION, KYIV, UKRAINE.'}, {'ForeName': 'Alla D', 'Initials': 'AD', 'LastName': 'Vitiuk', 'Affiliation': 'SHUPYK NATIONAL MEDICAL ACADEMY OF POSTGRADUATE EDUCATION, KYIV, UKRAINE.'}]","Wiadomosci lekarskie (Warsaw, Poland : 1960)",[] 3517,33851547,How Does Green Dot Bystander Training in High School and Beyond Impact Attitudes Toward Violence and Sexism in a Prospective Cohort?,"Bystander interventions are recognized as ""promising"" programming to reduce sexual violence. Gaps in current evaluations include limited follow-up post-training (beyond 24 months) and knowledge of additional bystander training during follow-up.In this prospective cohort study, nested in a cluster randomized controlled trial (RCT), three cohorts of high school (HS) seniors were recruited (Fall 2013-2015) and followed through Spring 2018 ( n = 1,831). Training was based on their school cluster RCT assignment and receipt of additional Green Dot (GD) training after HS. Training was hypothesized to be associated with lower scores indicating less acceptance of violence or sexism.Sixty percent reported GD training after HS (68.7% of 986 in intervention and 50% of 845 in control conditions). No significant differences ( p < .05) were observed by GD training for four of the five violence acceptance or sexism attitudinal measures at recruitment or final surveys. For ""ambivalent sexism"" alone was there a significant reduction in scale scores over time in the intervention versus control condition. Additional GD training after the RCT significantly reduced neither violence acceptance nor sexism scores over time.GD training does not appear to have a consistent longer-term impact on reducing violence acceptance and sexism.",2021,"For ""ambivalent sexism"" alone was there a significant reduction in scale scores over time in the intervention versus control condition.","['three cohorts of high school (HS) seniors were recruited (Fall 2013-2015) and followed through Spring 2018 ( n = 1,831']","['Green Dot Bystander Training', 'GD training']","['acceptance of violence or sexism', 'violence acceptance nor sexism scores', 'violence acceptance and sexism', 'GD training', 'scale scores']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial dots'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0205906', 'cui_str': 'Gender Bias'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.010415,"For ""ambivalent sexism"" alone was there a significant reduction in scale scores over time in the intervention versus control condition.","[{'ForeName': 'Ann L', 'Initials': 'AL', 'LastName': 'Coker', 'Affiliation': 'University of Kentucky, Lexington, USA.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Bush', 'Affiliation': 'University of Kentucky, Lexington, USA.'}, {'ForeName': 'Zhengyan', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'University of Kentucky, Lexington, USA.'}, {'ForeName': 'Candace J', 'Initials': 'CJ', 'LastName': 'Brancato', 'Affiliation': 'University of Kentucky, Lexington, USA.'}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Clear', 'Affiliation': 'University of Kentucky, Lexington, USA.'}, {'ForeName': 'Diane R', 'Initials': 'DR', 'LastName': 'Follingstad', 'Affiliation': 'University of Kentucky, Lexington, USA.'}]",Journal of interpersonal violence,['10.1177/08862605211006354'] 3518,33851461,"Effects of Nigella sativa oil supplementation on selected metabolic parameters and anthropometric indices in patients with coronary artery disease: A randomized, double-blind, placebo-controlled clinical trial.","Various metabolic parameters are risk factors related to the amplified risk of atherosclerotic cardiovascular disease. A wide variety of data exist on Nigella sativa (NS) and metabolic parameters. The current study is designed to examine NS supplementation on lipid profile, blood pressure, glycemic control, anthropometric indices, and insulin resistance in individuals with coronary artery disease (CAD). In a randomized, double-blind, placebo-controlled clinical trial, 60 patients with CAD received either 2 g of NS oil or sunflower oil as a placebo for 8 weeks. Biochemical and anthropometric measurements were assessed. NS significantly reduced weight (-1.82 Kg; 95% C, [2.72, 4.13]), body mass index (-0.67 kg/m 2 ; 95% C, [0.33, 1.01]), waist circumference (-2.15 cm; 95% C, [1.06, 3.23]), hip circumference (-1.26 cm; 95% C, [0.61, 1.910]), waist-to-hip ratio (0.008; 95%C, [0.001, 0.01]), systolic (-9.52 mmHg; 95% C, [7.14, 11.9]), diastolic blood pressure (-8.26 mmHg; 95% C, [4.89, 11.62]), and fasting blood glucose (FBS) (-4.32 mg/dl; 95% C, [-0.51, 9.15]) as compared with the placebo group. The results indicate a potential beneficiary effect of NS on the metabolic parameters in CAD patients including improvements in anthropometric indices, blood pressure, and FBS.",2021,"NS significantly reduced weight (-1.82 Kg; 95% C, [2.72, 4.13]),","['patients with coronary artery disease', 'individuals with coronary artery disease (CAD', '60 patients with CAD']","['placebo', '2\u2009g of NS oil or sunflower oil as a placebo', 'NS supplementation', 'Nigella sativa oil supplementation']","['selected metabolic parameters and anthropometric indices', 'diastolic blood pressure ', 'waist circumference', 'systolic', 'Biochemical and anthropometric measurements', 'fasting blood glucose (FBS', 'Nigella sativa (NS) and metabolic parameters', 'waist-to-hip ratio', 'anthropometric indices, blood pressure, and FBS', 'body mass index', 'reduced weight', 'lipid profile, blood pressure, glycemic control, anthropometric indices, and insulin resistance', 'hip circumference ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3651714', 'cui_str': 'NIGELLA SATIVA SEED OIL'}, {'cui': 'C0947381', 'cui_str': 'Helianthus annuus'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C1140702', 'cui_str': 'Cumin, Black'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C3495427', 'cui_str': 'Fanconi-Bickel Syndrome'}, {'cui': 'C1140702', 'cui_str': 'Cumin, Black'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}]",60.0,0.586897,"NS significantly reduced weight (-1.82 Kg; 95% C, [2.72, 4.13]),","[{'ForeName': 'Omid Mohammad', 'Initials': 'OM', 'LastName': 'Tavakoli-Rouzbehani', 'Affiliation': 'Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Abbasnezhad', 'Affiliation': 'Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Sorayya', 'Initials': 'S', 'LastName': 'Kheirouri', 'Affiliation': 'Department of Clinical Nutrition, Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Alizadeh', 'Affiliation': 'Nutrition Research Center, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.7115'] 3519,33851448,"The effects of nano-curcumin supplementation on glycemic control, blood pressure, lipid profile, and insulin resistance in patients with the metabolic syndrome: A randomized, double-blind clinical trial.","Metabolic syndrome (MetS) is one of the most important health hazards. Curcumin is extracted from Curcuma longa (turmeric), which can affect the components of MetS. To increase the oral bioavailability of curcumin, nano-micelle curcumin is used instead of curcumin powder. In this randomized, double-blind, controlled clinical trial, 50 patients with MetS were randomly assigned to two groups to receive either 80 mg/day nano-curcumin (n = 25) or placebo (n = 25), for 12 weeks anthropometric measurements, blood pressure, and biochemical factors-including fasting blood sugar (FBS), Hemoglobin A1c (HbA1c), homeostatic model assessment (HOMA) for insulin resistance (HOMA-IR), pancreatic β cell function (HOMA-β) and lipid profile-were assessed at the baseline and the end of the study. Statistical analyses were done using SPSS software (Version 23). The analysis between the two groups has illustrated a significant reduction in the average change of triglyceride (TG) levels (-60.5 ± 121.7 vs. 13.1 ± 78.1 mg/dL; p < .05) and HOMA-β (-5.7 ± 48.2 vs. -4.01 ± 16.9; p < .05). But there were no significant differences in anthropometric measurements, blood pressure and biochemical factors-including FBS, HbA1c, HOMA-IR, HOMA-β, and lipid profile variables include (total cholesterol, LDL-C, and HDL-C) at the end of the study. In conclusion, supplementation with nano-micelle curcumin significantly improved serum TG in MetS patients.",2021,"But there were no significant differences in anthropometric measurements, blood pressure and biochemical factors-including FBS, HbA1c, HOMA-IR, HOMA-β, and lipid profile variables include (total cholesterol, LDL-C, and HDL-C) at the end of the study.","['patients with the metabolic syndrome', '50 patients with MetS']","['80\u2009mg/day nano-curcumin', 'placebo', 'nano-curcumin supplementation']","['anthropometric measurements, blood pressure and biochemical factors-including FBS, HbA1c, HOMA-IR, HOMA-β, and lipid profile variables include (total cholesterol, LDL-C, and HDL-C', 'blood pressure, and biochemical factors-including fasting blood sugar (FBS), Hemoglobin A1c (HbA1c), homeostatic model assessment (HOMA) for insulin resistance (HOMA-IR), pancreatic β cell function (HOMA-β) and lipid profile', 'glycemic control, blood pressure, lipid profile, and insulin resistance', 'average change of triglyceride (TG) levels', 'serum TG']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}]",50.0,0.38468,"But there were no significant differences in anthropometric measurements, blood pressure and biochemical factors-including FBS, HbA1c, HOMA-IR, HOMA-β, and lipid profile variables include (total cholesterol, LDL-C, and HDL-C) at the end of the study.","[{'ForeName': 'Zohre', 'Initials': 'Z', 'LastName': 'Bateni', 'Affiliation': 'Clinical Nutrition and Dietetics Department, Faculty of Nutrition Sciences and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Rahimi', 'Affiliation': 'Department of Modern Sciences and Technologies, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hedayati', 'Affiliation': 'Cellular and Molecular Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shila', 'Initials': 'S', 'LastName': 'Afsharian', 'Affiliation': 'Endocrine Research Center, Research Institute foe Endocrine Science, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Razieh', 'Initials': 'R', 'LastName': 'Goudarzi', 'Affiliation': 'Clinical Nutrition and Dietetics Department, Faculty of Nutrition Sciences and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Golbon', 'Initials': 'G', 'LastName': 'Sohrab', 'Affiliation': 'Clinical Nutrition and Dietetics Department, Faculty of Nutrition Sciences and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.7109'] 3520,33851442,The impact of COVID-19 on body-dissatisfied female university students.,"OBJECTIVE This study investigated the impact of COVID-19 on young women's disordered eating and their responses to online interventions to reduce disordered eating. METHOD University students at risk of developing an eating disorder (N = 100) were randomly assigned to either receiving an online intervention to reduce disordered eating or not. Forty-one participants entered the study from September 2019 to March 2020 (pre-COVID) and 59 after physical distancing was introduced due to COVID pandemic (during COVID). Online assessments were conducted at baseline and 1-week follow up. RESULTS There was a significant increase in weight concerns, disordered eating, and negative affect among participants entering the trial during COVID compared to pre-COVID. The increases in the first two variables remained when adjusting for baseline negative affect. No significant interactions between time, condition and COVID status were observed. DISCUSSION Young women experienced increased levels of disordered eating after the onset of COVID. While no interactions with COVID were detected, changes to within-group effect sizes for disordered eating more than doubled for both online interventions and assessment from pre-COVID to during COVID, suggesting any attention to issues related to disordered eating in the context of reduced social contact may be beneficial.",2021,"This study investigated the impact of COVID-19 on young women's disordered eating and their responses to online interventions to reduce disordered eating. ","['body-dissatisfied female university students', 'University students at risk of developing an eating disorder (N = 100', ""young women's disordered eating"", 'Forty-one participants entered the study from September 2019 to March 2020 (pre-COVID) and 59 after physical distancing was introduced due to COVID pandemic (during COVID', 'Young women']","['COVID-19', 'online intervention to reduce disordered eating or not']","['levels of disordered eating', 'time, condition and COVID status', 'weight concerns, disordered eating, and negative affect']","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1292748', 'cui_str': 'Introduces'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",100.0,0.0292412,"This study investigated the impact of COVID-19 on young women's disordered eating and their responses to online interventions to reduce disordered eating. ","[{'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'College of Education Psychology & Social Work, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Tracey D', 'Initials': 'TD', 'LastName': 'Wade', 'Affiliation': 'College of Education Psychology & Social Work, Flinders University, Adelaide, South Australia, Australia.'}]",The International journal of eating disorders,['10.1002/eat.23521'] 3521,33851429,Dopamine agonists for preventing ovarian hyperstimulation syndrome.,"BACKGROUND Ovarian hyperstimulation syndrome (OHSS) is a potentially serious complication of ovarian stimulation in assisted reproduction technology (ART). It is characterised by enlarged ovaries and an acute fluid shift from the intravascular space to the third space, resulting in bloating, increased risk of venous thromboembolism, and decreased organ perfusion. Most cases are mild, but forms of moderate or severe OHSS appear in 3% to 8% of in vitro fertilisation (IVF) cycles. Dopamine agonists were introduced as a secondary prevention intervention for OHSS in women at high risk of OHSS undergoing ART treatment.  OBJECTIVES: To assess the effectiveness and safety of dopamine agonists in preventing OHSS in women at high risk of developing OHSS when undergoing ART treatment. SEARCH METHODS We searched the following databases from inception to 4 May 2020: Cochrane Gynaecology and Fertility Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, and PsycINFO for randomised controlled trials (RCTs) assessing the effect of dopamine agonists on OHSS rates. We also handsearched reference lists and grey literature. SELECTION CRITERIA We considered RCTs for inclusion that compared dopamine agonists with placebo/no intervention or another intervention for preventing OHSS in ART. Primary outcome measures were incidence of moderate or severe OHSS and live birth rate. Secondary outcomes were rates of clinical pregnancy, multiple pregnancy, miscarriage, and adverse events. DATA COLLECTION AND ANALYSIS Two review authors independently screened titles, abstracts, and full texts of publications; selected studies; extracted data; and assessed risk of bias. We resolved disagreements  by consensus. We reported pooled results as odds ratios (OR) and 95% confidence interval (CI) by the Mantel-Haenszel method. We applied GRADE criteria to judge overall quality of the evidence. MAIN RESULTS The search identified six new RCTs, resulting in 22 included RCTs involving 3171 women at high risk of OHSS for this updated review. The dopamine agonists were cabergoline, quinagolide, and bromocriptine. Dopamine agonists versus placebo or no intervention Dopamine agonists probably lowered the risk of moderate or severe OHSS compared to placebo/no intervention (OR 0.32, 95% CI 0.23 to 0.44; 10 studies, 1202 participants; moderate-quality evidence). This suggests that if the risk of moderate or severe OHSS following placebo/no intervention is assumed to be 27%, the risk following dopamine agonists would be between 8% and 14%. We are uncertain of the effect of dopamine agonists on rates of live birth (OR 0.96, 95% CI 0.60 to 1.55; 3 studies, 362 participants; low-quality evidence). We are also uncertain of the effect of dopamine agonists on clinical pregnancy, multiple pregnancy, miscarriage  or adverse events (very low to low-quality evidence). Dopamine agonists plus co-intervention versus co-intervention Dopamine agonist plus co-intervention (hydroxyethyl starch, human albumin, or withholding ovarian stimulation 'coasting') may decrease the risk of moderate or severe OHSS compared to co-intervention (OR 0.48, 95% CI 0.28 to 0.84; 4 studies, 748 participants; low-quality evidence). Dopamine agonists may improve rates of live birth (OR 1.21, 95% CI 0.81 to 1.80; 2 studies, 400 participants; low-quality evidence). Dopamine agonists may improve rates of clinical pregnancy and miscarriage, but we are uncertain if they improve rates of multiple pregnancy  or adverse events (very low to low-quality evidence). Dopamine agonists versus other active interventions We are uncertain if cabergoline improves the risk of moderate or severe OHSS compared to human albumin (OR 0.21, 95% CI 0.12 to 0.38; 3 studies, 296 participants; very low-quality evidence), prednisolone (OR 0.27, 95% CI 0.05 to 1.33; 1 study; 150 participants; very low-quality evidence), hydroxyethyl starch (OR 2.69, 95% CI 0.48 to 15.10; 1 study, 61 participants; very low-quality evidence), coasting (OR 0.42, 95% CI 0.18 to 0.95; 3 studies, 320 participants; very low-quality evidence), calcium infusion (OR 1.83, 95% CI 0.88 to 3.81; I² = 81%; 2 studies, 400 participants; very low-quality evidence), or diosmin (OR 2.85, 95% CI 1.35 to 6.00; 1 study, 200 participants; very low-quality evidence). We are uncertain of the effect of dopamine agonists on rates of live birth (OR 1.08, 95% CI 0.73 to 1.59; 2 studies, 430 participants; low-quality evidence). We are uncertain of the effect of dopamine agonists on clinical pregnancy, multiple pregnancy or miscarriage (low to moderate-quality evidence). There were no adverse events reported. AUTHORS' CONCLUSIONS Dopamine agonists probably reduce the incidence of moderate or severe OHSS compared to placebo/no intervention, while we are uncertain of the effect on adverse events and pregnancy outcomes (live birth, clinical pregnancy, miscarriage). Dopamine agonists plus co-intervention may decrease moderate or severe OHSS rates compared to co-intervention only, but we are uncertain whether dopamine agonists affect pregnancy outcomes. When compared to other active interventions, we are uncertain of the effects of dopamine agonists on moderate or severe OHSS and pregnancy outcomes.",2021,"Dopamine agonists may improve rates of live birth (OR 1.21, 95% CI 0.81 to 1.80; 2 studies, 400 participants; low-quality evidence).","['Ovarian hyperstimulation syndrome (OHSS', 'women at high risk of OHSS undergoing ART treatment', 'women at high risk of developing OHSS when undergoing ART treatment', '3171 women at high risk of OHSS for this updated review']","[""Dopamine agonists plus co-intervention versus co-intervention Dopamine agonist plus co-intervention (hydroxyethyl starch, human albumin, or withholding ovarian stimulation 'coasting"", 'cabergoline, quinagolide, and bromocriptine', 'Dopamine agonists plus co-intervention', 'placebo', 'Dopamine agonists', 'Dopamine agonists versus placebo', 'dopamine agonists', 'prednisolone']","['clinical pregnancy, multiple pregnancy or miscarriage', 'hydroxyethyl starch', 'risk of moderate or severe OHSS', 'OHSS rates', 'moderate or severe OHSS rates', 'ovarian hyperstimulation syndrome', 'incidence of moderate or severe OHSS and live birth rate', 'rates of live birth', 'adverse events and\xa0pregnancy outcomes (live birth, clinical pregnancy,\xa0miscarriage', 'rates of\xa0live birth', 'rates of clinical pregnancy, multiple pregnancy, miscarriage, and adverse events']","[{'cui': 'C0085083', 'cui_str': 'Ovarian hyperstimulation syndrome'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0282443', 'cui_str': 'Review'}]","[{'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0020352', 'cui_str': 'Hetastarch'}, {'cui': 'C0304925', 'cui_str': 'Albumin Human, USP'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0107994', 'cui_str': 'cabergoline'}, {'cui': 'C0256089', 'cui_str': 'quinagolide'}, {'cui': 'C0006230', 'cui_str': 'Bromocriptine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0032989', 'cui_str': 'Multiple pregnancy'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0020352', 'cui_str': 'Hetastarch'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0085083', 'cui_str': 'Ovarian hyperstimulation syndrome'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}]",3171.0,0.483052,"Dopamine agonists may improve rates of live birth (OR 1.21, 95% CI 0.81 to 1.80; 2 studies, 400 participants; low-quality evidence).","[{'ForeName': 'Huilin', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': 'Institute for Drug Evaluation, Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Selma M', 'Initials': 'SM', 'LastName': 'Mourad', 'Affiliation': 'Radboud University Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Aihua', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Department of Pharmacy, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Suo-Di', 'Initials': 'SD', 'LastName': 'Zhai', 'Affiliation': 'Department of Pharmacy, Therapeutic Drug Monitoring and Clinical Toxicology Center of Peking University, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Roger J', 'Initials': 'RJ', 'LastName': 'Hart', 'Affiliation': ""School of Women's and Infants' Health, The University of Western Australia, King Edward Memorial Hospital and Fertility Specialists of Western Australia, Subiaco, Perth, Australia.""}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD008605.pub4'] 3522,33851360,Satisfaction and genital perception after orchiectomy for prostate cancer: does the technique matter? A randomized trial.,"OBJECTIVES Bilateral extracapsular or total orchiectomy (BEO) for prostate cancer is presumed to have psychological consequences after the surgery due to perception of an empty scrotum. Bilateral subcapsular orchiectomy (BSO) was designed to preserve perception of palpable testes. We compared the patients' satisfaction and genital perception following BEO and BSO. MATERIALS AND METHODS Prostate cancer patients eligible for androgen deprivation therapy who opted for orchiectomy were enrolled in prospective randomized study. Patients with bleeding disorder or uncorrected coagulopathy, poor performance score, and psychiatric problems were excluded. Outlook to life and own health in-general, overall satisfaction to the procedure and genital perception was evaluated using modified Fugl-Meyer questionnaire (FMQ) which was administered before and after 3 months of the surgery. Patients were randomized to BEO and BSO groups at the time of surgery using block randomization. Primary outcome was to compare the genital perception of testicular loss and patients' satisfaction to BSO and BEO. Secondary outcomes included testosterone and PSA control, operative time, and complications. RESULTS Total 35 patients were enrolled in each group which was comparable. There was no difference in PSA control at 3 months. Mean operative time and blood loss were significantly lesser in BEO group. FMQ score at 3 months did not show significant difference. Majority of the patients in both groups were satisfied with procedure and the aesthetic value of scrotum after surgery. However, 84% in BSO group did not feel that testes were removed on self-examination, as compared to 28% in BEO group. Majority patients in both groups did not report physical or psychological discomfort from change in scrotal content. CONCLUSIONS Results showed that patients' satisfaction and genital perception following BSO and BEO were similar. Feeling of remaining intrascrotal contents after BSO did not had added psychological advantage in terms of perception of genitalia.",2021,Feeling of remaining intrascrotal contents after BSO did not had added psychological advantage in terms of perception of genitalia.,"['prostate cancer', 'Prostate cancer patients eligible for androgen deprivation therapy who opted for orchiectomy', 'Total 35 patients', 'Patients with bleeding disorder or uncorrected coagulopathy, poor performance score, and psychiatric problems were excluded']","['BEO and BSO', 'Bilateral subcapsular orchiectomy (BSO', 'Bilateral extracapsular or total orchiectomy (BEO']","['testosterone and PSA control, operative time, and complications', 'Mean operative time and blood loss', 'report physical or psychological discomfort', 'satisfaction and genital perception following BSO and BEO', 'Satisfaction and genital perception', 'FMQ score', 'PSA control', ""genital perception of testicular loss and patients' satisfaction to BSO and BEO""]","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0029189', 'cui_str': 'Testis excision'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0029189', 'cui_str': 'Testis excision'}, {'cui': 'C0205152', 'cui_str': 'Subcapsular'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205152', 'cui_str': 'Subcapsular'}, {'cui': 'C0029189', 'cui_str': 'Testis excision'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",35.0,0.0290749,Feeling of remaining intrascrotal contents after BSO did not had added psychological advantage in terms of perception of genitalia.,"[{'ForeName': 'Onkar', 'Initials': 'O', 'LastName': 'Singh', 'Affiliation': 'Department of Urology, Christian Medical College and Hospital, Vellore, Tamil Nadu, 632004, India. dronkarsingh@gmail.com.'}, {'ForeName': 'Partho', 'Initials': 'P', 'LastName': 'Mukherjee', 'Affiliation': 'Department of Urology, Christian Medical College and Hospital, Vellore, Tamil Nadu, 632004, India.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Sakthivel', 'Affiliation': 'Department of Urology, Christian Medical College and Hospital, Vellore, Tamil Nadu, 632004, India.'}, {'ForeName': 'Cornerstone', 'Initials': 'C', 'LastName': 'Wann', 'Affiliation': 'Department of Urology, Christian Medical College and Hospital, Vellore, Tamil Nadu, 632004, India.'}, {'ForeName': 'A J P', 'Initials': 'AJP', 'LastName': 'George', 'Affiliation': 'Department of Urology, Christian Medical College and Hospital, Vellore, Tamil Nadu, 632004, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Gopalakrishnan', 'Affiliation': 'Department of Psychiatry, Christian Medical College, Bagayam Campus, Vellore, 632004, Tamil Nadu, India.'}, {'ForeName': 'Belavendra', 'Initials': 'B', 'LastName': 'Antonisamy', 'Affiliation': 'Department of Biostatistics, Christian Medical College, Bagayam Campus, Vellore, 632004, Tamil Nadu, India.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Devasia', 'Affiliation': 'Department of Urology, Christian Medical College and Hospital, Vellore, Tamil Nadu, 632004, India.'}, {'ForeName': 'Santosh', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Department of Urology, Christian Medical College and Hospital, Vellore, Tamil Nadu, 632004, India.'}, {'ForeName': 'Nitin S', 'Initials': 'NS', 'LastName': 'Kekre', 'Affiliation': 'Department of Urology, Christian Medical College and Hospital, Vellore, Tamil Nadu, 632004, India.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Chandrasingh', 'Affiliation': 'Department of Urology, Christian Medical College and Hospital, Vellore, Tamil Nadu, 632004, India.'}]",International urology and nephrology,['10.1007/s11255-021-02849-z'] 3523,33851349,Efficacy and safety of bosutinib versus imatinib for newly diagnosed chronic myeloid leukemia in the Asian subpopulation of the phase 3 BFORE trial.,"Bosutinib is approved in the United States, Europe, Japan, and other countries for treatment of newly diagnosed chronic phase (CP) chronic myeloid leukemia (CML), and CML resistant/intolerant to prior therapy. In the phase 3 BFORE trial (Clinicaltrials.gov, NCT02130557), patients were randomized 1:1 to first-line bosutinib or imatinib 400 mg once daily. We examined efficacy, safety, and patient-reported outcomes of bosutinib vs imatinib and pharmacokinetics of bosutinib in the Asian (n = 33 vs 34) and non-Asian (n = 235 vs 234) subpopulations of BFORE followed for at least 24 months. At the data cutoff date, 72.7 vs 66.7% of Asian and 70.6 vs 66.4% of non-Asian patients remained on treatment. The major molecular response rate at 24 months favored bosutinib vs imatinib among Asian (63.6 vs 38.2%) and non-Asian (60.9 vs 52.6%) patients, as did the complete cytogenetic response rate by 24 months (86.7 vs 76.7%, 81.5 vs 76.3%). Treatment-emergent adverse events in both subpopulations were consistent with the primary BFORE results. Trough bosutinib concentration levels tended to be higher in Asian patients. Health-related quality of life was maintained after 12 months of bosutinib in both subpopulations. These results support bosutinib as a first-line treatment option in Asian patients with CP CML.",2021,"The major molecular response rate at 24 months favored bosutinib vs imatinib among Asian (63.6 vs 38.2%) and non-Asian (60.9 vs 52.6%) patients, as did the complete cytogenetic response rate by 24 months (86.7 vs 76.7%, 81.5 vs 76.3%).","['Asian (n\u2009=\u200933 vs 34) and non-Asian (n\u2009=\u2009235 vs 234) subpopulations of BFORE followed for at least 24\xa0months', 'Asian patients with CP CML', 'newly diagnosed chronic myeloid leukemia in the Asian subpopulation of the phase 3 BFORE trial']","['bosutinib versus imatinib', 'imatinib 400\xa0mg once daily']","['Health-related quality of life', 'major molecular response rate', 'complete cytogenetic response rate', 'Trough bosutinib concentration levels', 'Efficacy and safety']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C1257890', 'cui_str': 'Group'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023474', 'cui_str': 'Chronic phase chronic myeloid leukemia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0023473', 'cui_str': 'Chronic myeloid leukemia'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1831731', 'cui_str': 'bosutinib'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C1331284', 'cui_str': 'imatinib 400 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4055168', 'cui_str': 'Cytogenetic response'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C1831731', 'cui_str': 'bosutinib'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0621381,"The major molecular response rate at 24 months favored bosutinib vs imatinib among Asian (63.6 vs 38.2%) and non-Asian (60.9 vs 52.6%) patients, as did the complete cytogenetic response rate by 24 months (86.7 vs 76.7%, 81.5 vs 76.3%).","[{'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Chuah', 'Affiliation': 'Singapore General Hospital, Duke-NUS Medical School, 20 College Road, Singapore, 169856, Singapore. charles.chuah.t.h@singhealth.com.sg.'}, {'ForeName': 'Liang Piu', 'Initials': 'LP', 'LastName': 'Koh', 'Affiliation': 'National University Cancer Institute, Singapore, Singapore.'}, {'ForeName': 'Tontanai', 'Initials': 'T', 'LastName': 'Numbenjapon', 'Affiliation': 'Phramongkutklao Hospital, Phramongkutklao College of Medicine, Bangkok, Thailand.'}, {'ForeName': 'Dae Young', 'Initials': 'DY', 'LastName': 'Zang', 'Affiliation': 'Hallym University Sacred Heart Hospital, Anyang, Republic of Korea.'}, {'ForeName': 'Kiat Hoe', 'Initials': 'KH', 'LastName': 'Ong', 'Affiliation': 'Tan Tock Seng Hospital, Singapore, Singapore.'}, {'ForeName': 'Young Rok', 'Initials': 'YR', 'LastName': 'Do', 'Affiliation': 'Dongsan Medical Center, Keimyung University, Daegu, Republic of Korea.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Ohkura', 'Affiliation': 'Pfizer R&D Japan GK, Tokyo, Japan.'}, {'ForeName': 'Chiho', 'Initials': 'C', 'LastName': 'Ono', 'Affiliation': 'Pfizer Japan Inc, Tokyo, Japan.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Viqueira', 'Affiliation': 'Pfizer SLU, Madrid, Spain.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Cortes', 'Affiliation': 'Georgia Cancer Center at Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Tim H', 'Initials': 'TH', 'LastName': 'Brümmendorf', 'Affiliation': 'Universitätsklinikum RWTH Aachen, Aachen, Germany.'}]",International journal of hematology,['10.1007/s12185-021-03144-4'] 3524,33851258,Comparison of stimulating dissector and intermittent stimulating probe for the identification of recurrent laryngeal nerve in reoperative setting.,"PURPOSE Recurrent laryngeal nerve (RLN) paralysis is one of the most devastating complications after thyroidectomy. Thyroid reoperation is a great challenge for surgeons due to anatomical distortion and fibrosis and associated with a higher risk of RLN injury. In this study, we aimed to compare stimulating dissector (SD) with intermittent stimulating probe (ISP) in thyroid reoperations. This study is the first one which compares the impact of different nerve stimulating devices in thyroid reoperations. METHODS Included in this randomized prospective study were patients who had a bilateral subtotal thyroidectomy and would undergo a completion thyroidectomy due to a diagnosis of thyroid papillary cancer between January 2015 and January 2017. Patients were divided into two groups as SD group and ISP group. Age, sex, nerve amplitudes, latencies, the first identification time of RLN and complications were compared in both groups. RESULTS A total of 32 patients, 16 in both groups, were included in the study. The demographics, nerve signal amplitudes and latencies were similar in both groups (p > 0.05). The mean RLN identification time in the SD group was 17.4 ± 4.3 min, which was significantly shorter than those in the ISP group (mean 21.3 ± 3.9) (p = 0.014). CONCLUSION The first identification of RLN in the thyroid reoperations was faster with the use of SD than with the use of the ISP. Since the electromyographic amplitudes of RLN and vagus nerve with using SD were similar to the bipolar ISP, SD can be used safely for thyroid reoperations.",2021,"The demographics, nerve signal amplitudes and latencies were similar in both groups (p > 0.05).","['recurrent laryngeal nerve in reoperative setting', 'patients who had a bilateral subtotal thyroidectomy and would undergo a completion thyroidectomy due to a diagnosis of thyroid papillary cancer between January 2015 and January 2017', 'thyroid reoperations', 'A total of 32 patients, 16 in both groups, were included in the study']","['ISP', 'stimulating dissector (SD) with intermittent stimulating probe (ISP', 'stimulating dissector and intermittent stimulating probe']","['mean RLN identification time', 'demographics, nerve signal amplitudes and latencies']","[{'cui': 'C0034898', 'cui_str': 'Structure of recurrent laryngeal nerve'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0193790', 'cui_str': 'Subtotal thyroidectomy'}, {'cui': 'C4304448', 'cui_str': 'Completion thyroidectomy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0238463', 'cui_str': 'Papillary thyroid carcinoma'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0180479', 'cui_str': 'Dissector'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034898', 'cui_str': 'Structure of recurrent laryngeal nerve'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}]",32.0,0.0170627,"The demographics, nerve signal amplitudes and latencies were similar in both groups (p > 0.05).","[{'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Karaisli', 'Affiliation': 'Department of General Surgery, Izmir Kâtip Celebi University Ataturk Training and Research Hospital, Izmir, Turkey. skaraisli@hotmail.com.'}, {'ForeName': 'Selda', 'Initials': 'S', 'LastName': 'Gucek Haciyanli', 'Affiliation': 'Department of General Surgery, Izmir Kâtip Celebi University Ataturk Training and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Haciyanli', 'Affiliation': 'Department of General Surgery, Izmir Kâtip Celebi University Ataturk Training and Research Hospital, Izmir, Turkey.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-021-06801-w'] 3525,33851255,"A Single-Center, Randomized, Double-Blind Clinical Trial to Compare the Efficacy and Safety of a New Monophasic Hyaluronic Acid Filler and Biphasic Filler in Correcting Nasolabial Fold.","BACKGROUND Hyaluronic acid (HA) fillers have been widely used in humans since 1958 because of their biomedical safety. Restylane ® was introduced in the1990s as a favorable temporary filler option for facial augmentation. Subsequently, many new HA filler products, including the Sardenyashape ® , have been introduced, but comparative studies of these products are limited. Here, we compared tolerability (wrinkle severity rating scale, WSRS), pain (visual analog scale, VAS score), satisfaction (global esthetic improvement scale, GAIS), and safety of a new monophasic HA (MHA) filler (Sardenyashape ® ) containing lidocaine, used to correct nasolabial folds (NLFs), with those of biphasic HA (BHA) filler (Restylane LYFT ® ) containing lidocaine. METHODS We enrolled 96 participants with visible NLFs in this randomized, double-blind, single-center clinical study. Participants were injected with a new MHA filler in one NLF and a BHA filler and were reassessed for cosmetic changes at 8 and 24 weeks. Wrinkle severity was assessed using the 5-point WSRS. RESULTS At week 24, the mean improvement in WSRS compared to baseline was 1.92 ± 0.75 and 2.24 ± 0.66 for MHA and BHA fillers, respectively, and corresponding average pain values using the VAS score 30 min after the procedure were 0.04 ± 0.25 and 0.02 ± 0.15, respectively, showing no significant difference. Average GAIS values 8 weeks after the procedure with MHA and BHA fillers were 1.89 ± 0.77 and 1.40 ± 0.82, respectively (p < 0.001). Both fillers were well tolerated, with mild adverse reactions. CONCLUSION The evaluation of the effect of Sardenyashape ® with lidocaine on NLF in this study proved its effectiveness and safety for use in correcting NLF. LEVEL OF EVIDENCE II This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .",2021,"At week 24, the mean improvement in WSRS compared to baseline was 1.92 ± 0.75 and 2.24 ± 0.66 for MHA and BHA fillers, respectively, and corresponding average pain values using the VAS score 30 min after the procedure were 0.04 ± 0.25 and 0.02 ± 0.15, respectively, showing no significant difference.",['96 participants with visible NLFs'],"['New Monophasic Hyaluronic Acid Filler and Biphasic Filler', 'Hyaluronic acid (HA) fillers', 'lidocaine']","['Average GAIS values', 'tolerability (wrinkle severity rating scale, WSRS), pain (visual analog scale, VAS score), satisfaction (global esthetic improvement scale, GAIS), and safety of a new monophasic HA (MHA) filler (Sardenyashape ® ) containing lidocaine, used to correct nasolabial folds (NLFs), with those of biphasic HA (BHA) filler (Restylane LYFT ® ) containing lidocaine', 'mean improvement in WSRS', 'Wrinkle severity', 'average pain values']","[{'cui': 'C0205379', 'cui_str': 'Visible'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205186', 'cui_str': 'Monophasic'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0729441', 'cui_str': 'Filler'}, {'cui': 'C0205184', 'cui_str': 'Biphasic'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205186', 'cui_str': 'Monophasic'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0729441', 'cui_str': 'Filler'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0221328', 'cui_str': 'Nasolabial sulcus structure'}, {'cui': 'C0205184', 'cui_str': 'Biphasic'}, {'cui': 'C1101698', 'cui_str': 'Restylane'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",96.0,0.246293,"At week 24, the mean improvement in WSRS compared to baseline was 1.92 ± 0.75 and 2.24 ± 0.66 for MHA and BHA fillers, respectively, and corresponding average pain values using the VAS score 30 min after the procedure were 0.04 ± 0.25 and 0.02 ± 0.15, respectively, showing no significant difference.","[{'ForeName': 'Changho', 'Initials': 'C', 'LastName': 'Chung', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Nowon Eulji Medical Center, School of Medicine, Eulji University, 68, Hangeulbiseok-ro, Nowon-gu, Seoul, South Korea.'}, {'ForeName': 'Jong Hun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Nowon Eulji Medical Center, School of Medicine, Eulji University, 68, Hangeulbiseok-ro, Nowon-gu, Seoul, South Korea. joaljh@eulji.ac.kr.'}]",Aesthetic plastic surgery,['10.1007/s00266-021-02252-0'] 3526,33851246,Comparison of outpatient and inpatient spa therapy in knee osteoarthritis.,"Osteoarthritis (OA) is a common condition that impacts many people worldwide and involves weight-bearing joints, resulting in chronic pain. In this study, we aimed to compare the effectiveness of inpatient and outpatient physical therapy modalities and spa combination treatments on pain and functional status in patients with knee osteoarthritis. Seventy-four patients diagnosed with primary knee osteoarthritis were included in this study. The patients were randomized into two groups, inpatient (n = 37) and outpatient (n = 37) physical therapy. All patients received a physical therapy program (superficial heater + deep heater + transcutaneous electrical nerve stimulation) for 2 weeks and spa therapy. All cases were evaluated clinically, laboratory, and radiographically. In order to evaluate pain and functional status, the Visual Analogue Scale (VAS), Western Ontario and McMaster Universities osteoarthritis index (WOMAC), and Timed Up and Go (TUG) test were used before and after treatment. There was no significant difference between the two groups in the TUG test and WOMAC scores (p > 0.05). However, a significant difference was found in VAS scores in favor of the outpatient group (p < 0.05). As a result, although there was a significant improvement in pain scores in the outpatient group, multicenter studies with larger patient groups may provide more evidence.",2021,"However, a significant difference was found in VAS scores in favor of the outpatient group (p < 0.05).","['Seventy-four patients diagnosed with primary knee osteoarthritis', 'knee osteoarthritis', 'patients with knee osteoarthritis']","['physical therapy program (superficial heater + deep heater + transcutaneous electrical nerve stimulation', 'inpatient and outpatient physical therapy modalities and spa combination treatments']","['VAS scores', 'TUG test and WOMAC scores', 'pain and functional status, the Visual Analogue Scale (VAS), Western Ontario and McMaster Universities osteoarthritis index\xa0(WOMAC), and Timed\xa0Up and Go (TUG) test', 'pain scores', 'pain and functional status']","[{'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0336757', 'cui_str': 'Heater'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0949766', 'cui_str': 'Physical therapy procedure'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",74.0,0.00723946,"However, a significant difference was found in VAS scores in favor of the outpatient group (p < 0.05).","[{'ForeName': 'Mustafa Fatih', 'Initials': 'MF', 'LastName': 'Yaşar', 'Affiliation': 'Medical Faculty, Department of Physical Medicine and Rehabilitation, Bolu Abant Izzet Baysal University, 14020, Bolu, Turkey. mustafafy@hotmail.com.'}, {'ForeName': 'Elif', 'Initials': 'E', 'LastName': 'Yakşi', 'Affiliation': 'Medical Faculty, Department of Physical Medicine and Rehabilitation, Bolu Abant Izzet Baysal University, 14020, Bolu, Turkey.'}, {'ForeName': 'Ramazan', 'Initials': 'R', 'LastName': 'Kurul', 'Affiliation': 'Department of Physical Therapy and Rehabilitation, Faculty of Health Sciences, Bolu Abant Izzet Baysal University, Bolu, Turkey.'}, {'ForeName': 'Muhammed', 'Initials': 'M', 'LastName': 'Balcı', 'Affiliation': 'Medical Faculty, Department of Physical Medicine and Rehabilitation, Bolu Abant Izzet Baysal University, 14020, Bolu, Turkey.'}]",International journal of biometeorology,['10.1007/s00484-021-02122-z'] 3527,33851221,Gestational Folate and Folic Acid Intake among Women in Canada at Higher Risk of Pre-Eclampsia.,"BACKGROUND Periconceptional folic acid (FA) supplementation is recommended to prevent neural tube defects; however, the extent to which recommendations are met through dietary sources and supplements is not clear. OBJECTIVES Our objective was to evaluate the dietary and supplemental intakes of FA in a Canadian pregnancy cohort and to determine the proportions of pregnant women exceeding the Estimated Average Requirement (EAR) and Tolerable Upper Intake Level (UL). METHODS FACT (the Folic Acid Clinical Trial) was an international multicenter, randomized, double-blinded, placebo-controlled, phase III trial investigating FA for the prevention of pre-eclampsia in high-risk pregnancies. Participants were enrolled from Canadian sites at 8-16 weeks of gestation. Dietary and supplemental FA intake data were collected through participant interviews and FFQs at the time of FACT enrollment. Categorical data were summarized as n (%) and continuous data as median (IQR). RESULTS This study included 1198 participants. Participants consumed 485 μg dietary folate equivalents (DFE)/d (IQR: 370-630 μg DFE/d) from dietary sources of folate and FA. Through diet alone, 43.4% of participants consumed ≥520 μg DFE/d, the EAR for pregnant individuals. Of the 91.9% of participants who consumed daily FA supplements, 0.4% consumed <400 μg FA/d and 96.0% consumed ≥1000 μg/d, the UL for FA. Median (IQR) total folate intake was 2167 μg DFE/d (2032-2325 μg DFE/d); 95.3% of participants met or exceeded the EAR from all sources, but 1069 (89.2%) participants exceeded the UL. CONCLUSIONS The majority of participants in this Canadian pregnancy cohort did not consume the recommended amount of folate from dietary sources. However, most prenatal supplements contained 1000 μg FA, resulting in the majority of women exceeding the UL. With no additional benefit associated with FA intakes beyond the UL for most women, modification of prenatal supplement formulations may be warranted to ensure women meet but do not exceed recommended FA intakes.FACT was registered at clinicaltrials.gov as NCT01355159 and at isrctn.com as ISRCTN23781770.",2021,"Through diet alone, 43.4% of participants consumed ≥520 μg DFE/d, the EAR for pregnant individuals.","['pregnant women exceeding the Estimated Average Requirement (EAR) and Tolerable Upper Intake Level (UL', '1198 participants', 'Participants were enrolled from Canadian sites at 8-16 weeks of gestation', 'high-risk pregnancies', 'Women in Canada at Higher Risk of Pre-Eclampsia', 'Participants consumed 485\xa0μg dietary folate equivalents (DFE)/d (IQR: 370-630 μg DFE/d) from dietary sources of folate and FA']","['placebo', 'FA', 'Periconceptional folic acid (FA) supplementation']","['Gestational Folate and Folic Acid Intake', 'Median (IQR) total folate intake']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0242786', 'cui_str': 'High risk pregnancy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C4708165', 'cui_str': '630'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0564428', 'cui_str': 'Folate intake'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",1198.0,0.546233,"Through diet alone, 43.4% of participants consumed ≥520 μg DFE/d, the EAR for pregnant individuals.","[{'ForeName': 'Elaine G', 'Initials': 'EG', 'LastName': 'Rose', 'Affiliation': 'OMNI Research Group, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Malia S Q', 'Initials': 'MSQ', 'LastName': 'Murphy', 'Affiliation': 'OMNI Research Group, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Erwin', 'Affiliation': 'OMNI Research Group, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Muldoon', 'Affiliation': 'OMNI Research Group, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Alysha L J', 'Initials': 'ALJ', 'LastName': 'Harvey', 'Affiliation': 'OMNI Research Group, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Rennicks White', 'Affiliation': 'OMNI Research Group, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'MacFarlane', 'Affiliation': 'Nutrition Research Division, Health Canada, Ottawa, Ontario, Canada.'}, {'ForeName': 'Shi Wu', 'Initials': 'SW', 'LastName': 'Wen', 'Affiliation': 'OMNI Research Group, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Walker', 'Affiliation': 'OMNI Research Group, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}]",The Journal of nutrition,['10.1093/jn/nxab063'] 3528,33851120,Arteriovenous Fistula Versus Graft Access Strategy in Older Adults Receiving Hemodialysis: A Pilot Randomized Trial.,"Background It is unclear whether surgical placement of an arteriovenous (AV) fistula (AVF) confers substantial clinical benefits over an AV graft (AVG) in older adults with end-stage kidney disease (ESKD). We report vascular access outcomes of a pilot clinical trial. Study Design Pilot randomized parallel-group open-label trial. Setting & Participants Patients 65 years and older with ESKD and no prior AV access receiving maintenance hemodialysis through a tunneled central venous catheter referred for AV access placement by their treating nephrologist. Intervention Participants were randomly assigned in a 1:1 ratio to surgical placement of an AVG or AVF. Outcomes Index AV access primary failure, successful cannulation, adjuvant interventions and infections. Results Of 122 older adults receiving hemodialysis and no prior AV access surgery, 24% died before (n = 18) or were too sick for (n = 11) referral for a permanent AV access. Of 46 eligible patients, 36 (78%) consented and were randomly assigned to AVG (n = 18) and AVF (n = 18) placement, of whom 13 (72%) and 16 (89%) underwent index AV access surgical placement, respectively. At a median follow-up of 321.0 days, primary AV access failure was noted in 31% in each group. The proportion of patients with successful cannulation was 62% (8 of 13) in the AVG and 50% (8 of 16) in the AVF group; median times to successful cannulation were 75.0 and 113.5 days, respectively. Endovascular procedures were recorded in 38% and 44%, and surgical reinterventions, in 23% and 25%, respectively. AV access infection was seen in 3 (23%) and 2 (13%) patients, respectively. Limitations Small sample size precludes statistical inference. Conclusions Almost one-quarter of older adults with incident ESKD and a central venous catheter as primary access were not referred for AV access placement due to medical reasons. Based on these limited results, there is little reason to favor either an AVF or AVG in this population until results from a larger randomized clinical trial become available. Funding Government funding to an author (Dr Murea is supported by National Institutes of Health∖National Institute on Aging grant 1R03 AG060178-01). Trial Registration NCT03545113.",2021,It is unclear whether surgical placement of an arteriovenous (AV) fistula (AVF) confers substantial clinical benefits over an AV graft (AVG) in older adults with end-stage kidney disease (ESKD).,"['Setting & Participants\n\n\nPatients 65 years and older with ESKD and no prior AV access receiving maintenance hemodialysis through a tunneled central venous catheter referred for AV access placement by their treating nephrologist', 'Older Adults', '122 older adults receiving hemodialysis and no prior AV access surgery', 'older adults with end-stage kidney disease (ESKD', '46 eligible patients, 36 (78%) consented and were randomly assigned to AVG (n\xa0= 18) and AVF (n\xa0= 18) placement, of whom 13 (72%) and 16 (89%) underwent']","['Receiving Hemodialysis', 'surgical placement of an arteriovenous (AV) fistula (AVF', 'surgical placement of an AVG or AVF', 'Arteriovenous Fistula Versus Graft Access Strategy']","['primary AV access failure', 'AV access infection', 'Endovascular procedures', 'proportion of patients with successful cannulation', 'median times to successful cannulation', 'surgical reinterventions', 'Outcomes\n\n\nIndex AV access primary failure, successful cannulation, adjuvant interventions and infections']","[{'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0450109', 'cui_str': 'Arteriovenous'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C1145640', 'cui_str': 'Central venous catheter'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0260039', 'cui_str': 'Nephrologist'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0729665', 'cui_str': 'Arteriovenous graft'}, {'cui': 'C0449215', 'cui_str': 'aVF'}]","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula'}, {'cui': 'C0449215', 'cui_str': 'aVF'}, {'cui': 'C0729665', 'cui_str': 'Arteriovenous graft'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0444454', 'cui_str': 'Access'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0450109', 'cui_str': 'Arteriovenous'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C2936204', 'cui_str': 'Intravascular Techniques'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",122.0,0.352422,It is unclear whether surgical placement of an arteriovenous (AV) fistula (AVF) confers substantial clinical benefits over an AV graft (AVG) in older adults with end-stage kidney disease (ESKD).,"[{'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Robinson', 'Affiliation': 'Section on Nephrology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Randolph L', 'Initials': 'RL', 'LastName': 'Geary', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Ross P', 'Initials': 'RP', 'LastName': 'Davis', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Justin B', 'Initials': 'JB', 'LastName': 'Hurie', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Timothy K', 'Initials': 'TK', 'LastName': 'Williams', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Velazquez-Ramirez', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Shahriar', 'Initials': 'S', 'LastName': 'Moossavi', 'Affiliation': 'Section on Nephrology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Haiying', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Division of Public Health Sciences, Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Murea', 'Affiliation': 'Section on Nephrology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC.'}]",Kidney medicine,['10.1016/j.xkme.2020.11.016'] 3529,33851006,Effects of selective heart rate reduction with ivabradine on LV function and central hemodynamics in patients with chronic coronary syndrome.,"Objectives We assessed left ventricular (LV) function and central hemodynamic effects in patients with a heart rate (HR) at rest of ≥70 beats per minute (bpm) and chronic coronary syndrome (CCS) after long-term treatment with ivabradine compared to placebo by cardiac magnetic resonance (CMR) imaging. Methods and results In a randomized, double-blinded, prospective cross-over design, 23 patients (18 male, 5 female) were treated with ivabradine (7.5 mg bid) or placebo for 6 months. CMR imaging was performed at baseline and after 6 and 12 months to determine LV functional parameters.Mean resting HR on treatment with ivabradine was 58 ± 8.2 bpm and 70.2 ± 8.3 bpm during placebo (p < 0.0001).There was no difference in systolic LV ejection fraction (ivabradine 57.4 ± 11.2% vs placebo 53.0 ± 10.9%, p = 0.18), indexed end-diastolic (EDVi) or end-systolic volumes (ESVi). Indexed stroke volume (SVi) (ml/m 2 ) remained unchanged after treatment with ivabradine. Volume time curve parameters reflecting systolic LV function (peak ejection rate and time) were unaffected by ivabradine, while both peak filling rate (PFR) and PFR/EDV were significantly increased. Mean aortic velocity (cm/s) was significantly reduced during treatment with ivabradine (ivabradine 6.7 ± 2.7 vs placebo 9.0 ± 3.4, p = 0.01). Aortic flow parameters were correlated to parameters of vascular stiffness. The strongest correlation was revealed for mean aortic velocity with aortic distensibility (AD) (r = -0.86 [-0.90 to -0.85], p < 0.0001). Conclusion Long-term reduction of HR with ivabradine in patients with CCS improved diastolic function and reduced mean aortic flow velocity.",2021,"Volume time curve parameters reflecting systolic LV function (peak ejection rate and time) were unaffected by ivabradine, while both peak filling rate (PFR) and PFR/EDV were significantly increased.","['23 patients (18 male, 5 female', 'patients with chronic coronary syndrome', 'by cardiac magnetic resonance (CMR) imaging', 'patients with a heart rate (HR) at rest of\xa0≥70 beats per minute (bpm) and chronic coronary syndrome (CCS) after long-term treatment with']","['placebo', 'ivabradine']","['Indexed stroke volume (SVi', 'systolic LV ejection fraction ', 'Mean resting HR', 'Volume time curve parameters reflecting systolic LV function (peak ejection rate and time', 'peak filling rate (PFR) and PFR/EDV', 'left ventricular (LV) function and central hemodynamic effects', 'diastolic function and reduced mean aortic flow velocity', 'Mean aortic velocity', 'LV function and central hemodynamics', 'indexed end-diastolic (EDVi) or end-systolic volumes (ESVi', 'mean aortic velocity with aortic distensibility (AD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0439385', 'cui_str': 'beats/min'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0257190', 'cui_str': 'ivabradine'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0080310', 'cui_str': 'Left ventricular function'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0336969', 'cui_str': 'Ejection'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0918012', 'cui_str': 'Indexes as Topic'}, {'cui': 'C0444930', 'cui_str': 'End'}]",,0.129503,"Volume time curve parameters reflecting systolic LV function (peak ejection rate and time) were unaffected by ivabradine, while both peak filling rate (PFR) and PFR/EDV were significantly increased.","[{'ForeName': 'Anna Lena', 'Initials': 'AL', 'LastName': 'Hohneck', 'Affiliation': 'First Department of Medicine, University Medical Centre Mannheim (UMM), Faculty of Medicine Mannheim, University of Heidelberg and DZHK (German Centre for Cardiovascular Research) Partner Site Heidelberg/Mannheim, Mannheim, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fries', 'Affiliation': 'Clinic for Diagnostic and Interventional Radiology, Saarland University Medical Center, Saarland University, Homburg/Saar, Germany.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Stroeder', 'Affiliation': 'Clinic for Diagnostic and Interventional Radiology, Saarland University Medical Center, Saarland University, Homburg/Saar, Germany.'}, {'ForeName': 'Günther', 'Initials': 'G', 'LastName': 'Schneider', 'Affiliation': 'Clinic for Diagnostic and Interventional Radiology, Saarland University Medical Center, Saarland University, Homburg/Saar, Germany.'}, {'ForeName': 'Stephan Henrik', 'Initials': 'SH', 'LastName': 'Schirmer', 'Affiliation': 'Saarland University, Homburg/ Saar, Germany.'}, {'ForeName': 'Jan-Christian', 'Initials': 'JC', 'LastName': 'Reil', 'Affiliation': 'Second Department of Medicine, University Hospital Schleswig-Holstein Location Lübeck, Lübeck, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Department of Internal Medicine III, Saarland University Medical Center, Saarland University, Homburg/Saar, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Laufs', 'Affiliation': 'Clinic and Polyclinic for Cardiology, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Custodis', 'Affiliation': 'Department of Internal Medicine III, Saarland University Medical Center, Saarland University, Homburg/Saar, Germany.'}]",International journal of cardiology. Heart & vasculature,['10.1016/j.ijcha.2021.100757'] 3530,33850968,A Dance Program to Manage A Fatigue-Sleep Disturbance-Depression Symptom Cluster among Breast Cancer Patients Receiving Adjuvant Chemotherapy: A Feasibility Study.,"Objective Fatigue, sleep disturbance, and depression (FSD) are highly prevalent among breast cancer (BC) patients undergoing adjuvant chemotherapy, constituting a common symptom cluster (i.e., FSD cluster). Exercise is effective in relieving fatigue, alleviating sleep disturbance, and improving the quality of life (QoL) during adjuvant chemotherapy among these women. Therefore, this study aimed to assess the feasibility and acceptability of a dance program with social support elements for managing this symptom cluster. Methods A prospective randomized controlled design combined with a semi-structured interview was utilized. Twenty consented eligible participants were randomly assigned to a dance group or an attention control group after baseline assessment but before chemotherapy. The feasibility of recruitment, retention, intervention, and data collection procedures and the acceptability of exercise modality, hospital-based instruction, and home-based practice were collected by retrieving information from research documents and interviews by the principal investigator 4 weeks after the start of intervention. Results The recruitment and retention rates were 86.96% and 100.00%, respectively. Participants took about 30-40 min to complete the questionnaire. All the items were comprehensible. The baseline characteristics were comparable between groups, indicating that randomization was successful. The implementation procedure progressed smoothly. Dancing was considered interesting and easy, and participants would like to practice at home. Only minor adjustments would be needed for future studies. Conclusions This study demonstrated that the proposed dance program was feasible and acceptable for BC patients in hospital and home settings. A full-scale study is warranted to examine its effects on managing the FSD cluster and promoting QoL.",2021,Twenty consented eligible participants were randomly assigned to a dance group or an attention control group after baseline assessment but before chemotherapy.,"['BC patients in hospital and home settings', 'breast cancer (BC) patients undergoing adjuvant chemotherapy, constituting a common symptom cluster (i.e., FSD cluster', 'Twenty consented eligible participants', 'Breast Cancer Patients Receiving Adjuvant Chemotherapy']","['dance program with social support elements', 'dance group or an attention control group after baseline assessment but before chemotherapy']","['Objective\n\n\nFatigue, sleep disturbance, and depression (FSD', 'recruitment and retention rates', 'quality of life (QoL', 'relieving fatigue, alleviating sleep disturbance', 'feasibility and acceptability']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0645652,Twenty consented eligible participants were randomly assigned to a dance group or an attention control group after baseline assessment but before chemotherapy.,"[{'ForeName': 'Xiaole', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Marques S N', 'Initials': 'MSN', 'LastName': 'Ng', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Breast Surgery, Shaanxi Province Oncology Hospital, Xi'an, China.""}, {'ForeName': 'Pingli', 'Initials': 'P', 'LastName': 'Guo', 'Affiliation': ""Department of Breast Surgery, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Lulu', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""School of Nursing, Health Science Center, Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Wenqian', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': ""School of Nursing, Health Science Center, Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Mengyue', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""School of Nursing, Health Science Center, Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Winnie K W', 'Initials': 'WKW', 'LastName': 'So', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, China.'}]",Asia-Pacific journal of oncology nursing,['10.4103/2347-5625.308677'] 3531,33850960,"Intervention for Symptom Cluster Management of Fatigue, Loss of Appetite, and Anxiety among Patients with Lung Cancer undergoing Chemotherapy.","Objective Patients with lung cancer can experience various distressing symptoms. The present study aims to use symptom cluster management intervention based on symptom management theory to moderate the severity of symptom clusters, including fatigue, loss of appetite, and anxiety, in patients with lung cancer undergoing chemotherapy. Methods A quasi-experimental study was conducted using historical controls to assess and compare the effect of a novel symptom cluster management intervention on the severity of fatigue, loss of appetite, and anxiety in patients with lung cancer undergoing chemotherapy. Lung cancer patients were recruited from an outpatient chemotherapy unit at a university hospital in Thailand. Eighty participants were assigned equally to the experimental and control groups. The study outcomes, including fatigue, loss of appetite, and anxiety, were assessed with the Edmonton Symptom Assessment System at baseline and days 7, 14, and 28 postintervention. Repeated-measures ANOVA was analyzed to determine mean differences between groups across time. Results Overall, anxiety decreased gradually on days 7, 14, and 28 ( P < 0.001 for all time points) in the experimental group. Fatigue and loss of appetite also declined after days 14 ( P < 0.001) and 28 ( P < 0.001) compared to baseline. The significant effects of the interaction terms time × group ( P < 0.001) for all symptoms within the cluster indicate the benefit of the intervention over time. Conclusions The pattern of changes in the symptom cluster across the study period was significantly different between the two study groups. Patients in the experimental group reported an improvement in fatigue, loss of appetite, and anxiety over time after receiving the intervention. The results suggested that the symptom cluster management intervention provided a promising approach for the simultaneous treatment of multiple symptoms within a cluster.",2021,"Patients in the experimental group reported an improvement in fatigue, loss of appetite, and anxiety over time after receiving the intervention.","['Patients with Lung Cancer undergoing Chemotherapy', 'Eighty participants', 'Patients with lung cancer can experience various distressing symptoms', 'patients with lung cancer undergoing chemotherapy', 'Lung cancer patients were recruited from an outpatient chemotherapy unit at a university hospital in Thailand']",['novel symptom cluster management intervention'],"['Fatigue and loss of appetite', 'fatigue, loss of appetite, and anxiety', 'severity of fatigue, loss of appetite, and anxiety', 'Overall, anxiety', 'fatigue, loss of appetite, and anxiety over time', 'Fatigue, Loss of Appetite, and Anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",80.0,0.0583629,"Patients in the experimental group reported an improvement in fatigue, loss of appetite, and anxiety over time after receiving the intervention.","[{'ForeName': 'Thidarat', 'Initials': 'T', 'LastName': 'Khamboon', 'Affiliation': 'Department of Nursing, Faculty of Nursing, Naresuan University, Phitsanulok, Thailand.'}, {'ForeName': 'Intira', 'Initials': 'I', 'LastName': 'Pakanta', 'Affiliation': 'Department of Nursing, Faculty of Nursing, Naresuan University, Phitsanulok, Thailand.'}]",Asia-Pacific journal of oncology nursing,['10.4103/2347-5625.311003'] 3532,33850958,Effect of Electrical Stimulation on Gastrointestinal Symptoms in Lung Cancer Patients during Chemotherapy: A Randomized Controlled Trial.,"Objective The objective was to evaluate the effects of transcutaneous acupoint electric stimulation (TAES) and gastric electrical stimulation (GES) on cancer patients with chemotherapy-induced gastrointestinal (GI) symptoms. Methods A total of 122 lung cancer patients receiving chemotherapy were assigned randomly to the following two groups: control group (usual care group, n = 61) and intervention group (TAES plus GES, n = 61). TAES involved two acupoints such as Neiguan (PC6) and Zusanli (ST36). GES was performed at gastric pacing sites on the body surface such as the places of projection of gastric antrum and corpus on the body surface. GES was performed on these sites for 14 days continuously (25 min every time, once daily). The effects of TAES and GES on GI symptoms were assessed using the Memorial Symptom Assessment Scale on the day prior to chemotherapy (time point 1) and days 14 (time point 2) and 28 (time point 3) after chemotherapy. Results No significant differences in the demographic and disease-related variables were detected between the two groups. Differences in symptom occurrence and severity at time point 1 were not statistically significant between the two groups (both P > 0.05). At time points 2 and 3, GI symptoms such as loss of appetite, nausea, vomiting, diarrhea, and constipation in the stimulation group had statistically significantly improved compared with the control group (all P < 0.05). Conclusions TAES and GES were efficacious in relieving GI discomfort in lung cancer patients after chemotherapy. TAES combined with GES is a safe and easy-to-use tool to manage GI symptoms in practice.",2021,Differences in symptom occurrence and severity at time point 1 were not statistically significant between the two groups (both P > 0.05).,"['cancer patients with chemotherapy-induced gastrointestinal (GI) symptoms', 'lung cancer patients after chemotherapy', 'Lung Cancer Patients during Chemotherapy', '122 lung cancer patients receiving']","['transcutaneous acupoint electric stimulation (TAES) and gastric electrical stimulation (GES', 'TAES and GES', 'GES', 'Electrical Stimulation', 'TAES combined with GES', 'chemotherapy', 'control group (usual care group, n = 61) and intervention group (TAES plus GES', 'TAES']","['symptom occurrence and severity at time point 1', 'GI symptoms such as loss of appetite, nausea, vomiting, diarrhea, and constipation', 'GI symptoms', 'Gastrointestinal Symptoms', 'demographic and disease-related variables', 'relieving GI discomfort', 'Memorial Symptom Assessment Scale']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}]","[{'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C4761037', 'cui_str': 'Gastric electrical stimulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C1096250', 'cui_str': 'Gastrointestinal discomfort'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",122.0,0.0286944,Differences in symptom occurrence and severity at time point 1 were not statistically significant between the two groups (both P > 0.05).,"[{'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Mao', 'Affiliation': 'Department of Palliative Care, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Qinqin', 'Initials': 'Q', 'LastName': 'Cheng', 'Affiliation': 'Department of Pain Management, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Health Service, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Yongyi', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Hospital Office, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}]",Asia-Pacific journal of oncology nursing,['10.4103/apjon.apjon_61_20'] 3533,33850959,Cold Application and Exercise on Development of Peripheral Neuropathy during Taxane Chemotherapy in Breast Cancer Patients: A Randomized Controlled Trial.,"Objective Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of cancer treatment. There is no proven pharmacological application to prevent CIPN. This study was conducted to compare the effects of cold application and exercise on peripheral neuropathy development in patients with breast cancer who received taxane. Methods This was a multicenter clinical trial. The study was conducted as a randomized controlled trial on breast cancer patients who had chemotherapy-induced peripheral neuropathy complaints between July 2017 and January 2018 in an outpatient chemotherapy unit of training-research and a university hospital. A standardized, home-based, 12-week exercise program involved progressive strengthening, stretching, and balance exercises. Cold packs were applied for the duration of all 12 taxane infusions and then continued at home. The standard care protocol (information about side effects) of the clinic was used for patients in the control group. Data were collected via Patient Identification Form and CIPN Assessment Tool. Demographic data were evaluated by number and percentage ratios, and the study groups' mean scores were compared by Kruskal-Wallis and Wilcoxon analyses. The data were collected at two time points including baseline (T1) and week 12 (T2). Results The study was completed with a total of 90 patients, so that each of the study groups, exercise, cold application, and control groups, included 30 patients. The mean of pre- and posttest results in the cold applied group revealed an increase in hand numbness, weakness, and distress ( P < 0.05). However, no significant difference existed between the means of the pre- and the posttests in the exercise group ( P = 0.79-0.1). The mean scores of all the symptoms in the control group except the loss of balance increased significantly ( P < 0.05). Exercise reduced CIPN symptoms of numbness in hands ( P = 0.009) and in the feet ( P = 0.005) significantly compared to the cold application and control. Conclusions It was found that exercise was more effective than cold application in the management of CIPN.",2021,"Exercise reduced CIPN symptoms of numbness in hands ( P = 0.009) and in the feet ( P = 0.005) significantly compared to the cold application and control. ","['breast cancer patients who had chemotherapy-induced peripheral neuropathy complaints between July 2017 and January 2018 in an outpatient chemotherapy unit of training-research and a university hospital', 'Breast Cancer Patients', '90 patients, so that each of the study groups, exercise, cold application, and control groups, included 30 patients', 'patients with breast cancer who received taxane']","['Cold Application and Exercise', 'exercise program involved progressive strengthening, stretching, and balance exercises', 'Taxane Chemotherapy', 'cold application and exercise', 'Chemotherapy-induced peripheral neuropathy (CIPN']","['CIPN symptoms of numbness', 'peripheral neuropathy development', 'loss of balance', 'hand numbness, weakness, and distress']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0215136', 'cui_str': 'taxane'}]","[{'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}]","[{'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0241981', 'cui_str': 'Impairment of balance'}, {'cui': 'C0239832', 'cui_str': 'Numbness of hand'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",90.0,0.00520601,"Exercise reduced CIPN symptoms of numbness in hands ( P = 0.009) and in the feet ( P = 0.005) significantly compared to the cold application and control. ","[{'ForeName': 'Neriman Yükseltürk', 'Initials': 'NY', 'LastName': 'Şimşek', 'Affiliation': 'Department of Nursing Administration, Gülhane Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Ayten', 'Initials': 'A', 'LastName': 'Demir', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Ankara University, Ankara, Turkey.'}]",Asia-Pacific journal of oncology nursing,['10.4103/apjon.apjon-2075'] 3534,33850866,"Analgesic efficacy of imrecoxib for postoperative pain following oral surgery: a prospective randomized, active-controlled, non-inferiority trial.","Background Imrecoxib, a novel cyclooxygenase (COX-2) selective non-steroidal anti-inflammatory drug (NSAID), has been approved in China for more than 9 years. This study aimed to assess the efficacy and safety of imrecoxib compared with celecoxib for patients with moderate or severe acute pain following oral surgery. Methods Patients with moderate or severe pain within 6 hours following surgery were enrolled in this randomized, active-control trial. Patients were randomly assigned (1:1) to receive either imrecoxib or celecoxib. Pain assessments on the visual analog scale, verbal rating scale, and pain relief were conducted at 0.5, 1, 2, 4, 6, 9, 12, and 24 hours after the first dose. Adverse events were also recorded. Results Eighty-seven patients were approached from November 2018 to August 2019. Of these, 60 were eligible for randomization. Ultimately, 56 patients (imrecoxib group, n=27; celecoxib group, n=29) were included in the analysis. The difference in total pain relief (TOTPAR) between the imrecoxib and celecoxib groups was 1.03 [95% confidence interval (CI): -1.31-3.77], with the lower bound of the CI above the specified non-inferiority boundary. No perioperative complications were observed in the imrecoxib group during the 24-hour period after the first dose. Conclusions Imrecoxib could significantly relieve pain and has a non-inferior analgesic efficacy compared to celecoxib with good tolerance following oral surgery.",2021,"Conclusions Imrecoxib could significantly relieve pain and has a non-inferior analgesic efficacy compared to celecoxib with good tolerance following oral surgery.","['postoperative pain following oral surgery', 'patients with moderate or severe acute pain following oral surgery', '56 patients (imrecoxib group, n=27; celecoxib group, n=29) were included in the analysis', 'Eighty-seven patients were approached from November 2018 to August 2019', 'Methods\n\n\nPatients with moderate or severe pain within 6 hours following surgery']","['celecoxib', 'imrecoxib', 'imrecoxib or celecoxib']","['pain', 'Adverse events', 'Analgesic efficacy', 'perioperative complications', 'total pain relief (TOTPAR', 'efficacy and safety', 'visual analog scale, verbal rating scale, and pain relief']","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038908', 'cui_str': 'Oral surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C1505698', 'cui_str': 'Imrecoxib'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C1292428', 'cui_str': '6 hours'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C1505698', 'cui_str': 'Imrecoxib'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0458261', 'cui_str': 'Verbal rating scale'}]",87.0,0.289364,"Conclusions Imrecoxib could significantly relieve pain and has a non-inferior analgesic efficacy compared to celecoxib with good tolerance following oral surgery.","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Jiangsu Key Laboratory of Oral Diseases, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Jiangsu Key Laboratory of Oral Diseases, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Jiangsu Key Laboratory of Oral Diseases, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Heming', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Jiangsu Key Laboratory of Oral Diseases, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Jiangsu Hengrui Pharmaceutical Co., Ltd., Lianyungang, China.'}, {'ForeName': 'Linhu', 'Initials': 'L', 'LastName': 'Zou', 'Affiliation': 'Jiangsu Hengrui Pharmaceutical Co., Ltd., Lianyungang, China.'}, {'ForeName': 'Zhiwei', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': 'Jiangsu Hengrui Pharmaceutical Co., Ltd., Lianyungang, China.'}, {'ForeName': 'Jinqiang', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Jiangsu Hengrui Pharmaceutical Co., Ltd., Lianyungang, China.'}, {'ForeName': 'Huaiqi', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Jiangsu Key Laboratory of Oral Diseases, Nanjing Medical University, Nanjing, China.'}]",Annals of translational medicine,['10.21037/atm-21-264'] 3535,33850830,Protocolized ventilator weaning verses usual care: A randomized controlled trial.,"Background Protocolized ventilator weaning (PW) strategies utilizing spontaneous breathing trials (SBTs) result in shorter intubation duration and intensive care unit (ICU) length of stay (LOS). We compared respiratory therapy (RT)-driven PW versus usual care (UC) as it pertains to physiologic respiratory parameters, intubation duration, extubation success/reintubation rates, and ICU LOS. Methods prospective, multicentric, randomized controlled trial was performed in closed medical and surgical ICUs with 24/7 in-house intensivist coverage at six academic medical centers in a resource-limited setting from October 18, 2007, to May 03, 2014. Extubation readiness was determined by the attending physician (UC) or the respiratory therapist (PW) using predefined criteria and SBT. Physiologic variables, serial blood gas measurements, and weaning indices were assessed including the Rapid Shallow Breathing Index (RSBI), negative inspiratory force (NIF), occlusion pressure (P0.1), and dynamic and static compliance (C dyn and C s ). Results total of 5502 patients were randomized (PW 2787; UC 2715), of which 167 patients died without ventilator weaning (PW 90; UC 77) and 645 patients were excluded (PW 365; UC 280). Finally, a total of 4200 patients were analyzed (PW 2075; UC 2125). The PW group displayed improvements in minute ventilation ( P < 0.001), C s and C dyn (both P < 0.05), P0.1 ( P < 0.001), NIF ( P < 0.001), and RSBI ( P < 0.001). Early re-intubation (≤48 h) rates were lower in the PW group (16.7% vs. 24.8%; P < 0.0001), as were late re-intubation rates (5.2% vs. 25.8%; P < 0.0001). Intubation duration was longer in the PW group ( P < 0.001), however, hospital LOS was shorter ( P < 0.001). Mortality was unchanged ( P = 0.19). Conclusion PW with RT-driven extubation decisions is safe, effective, and associated with decreased re-intubation (early and late), shorter hospital stays, increased intubation duration (statistically but not clinically significant), and unchanged in-patient mortality.",2020,"Intubation duration was longer in the PW group ( P < 0.001), however, hospital LOS was shorter ( P < 0.001).","['closed medical and surgical ICUs with 24/7 in-house intensivist coverage at six academic medical centers in a resource-limited setting from October 18, 2007, to May 03, 2014', '5502 patients were randomized (PW 2787; UC 2715), of which 167 patients died without ventilator weaning (PW 90; UC 77) and 645 patients were excluded (PW 365; UC 280', '4200 patients were analyzed (PW 2075; UC 2125']","['\n\n\nProtocolized ventilator weaning (PW) strategies utilizing spontaneous breathing trials (SBTs', 'respiratory therapy (RT)-driven PW versus usual care (UC', 'Protocolized ventilator weaning verses usual care']","['Extubation readiness', 'minute ventilation', 'shorter intubation duration and intensive care unit (ICU) length of stay (LOS', 'Rapid Shallow Breathing Index (RSBI), negative inspiratory force (NIF), occlusion pressure (P0.1), and dynamic and static compliance (C dyn and C s ', 'Mortality', 'NIF', 're-intubation (early and late), shorter hospital stays, increased intubation duration', 'intubation duration, extubation success/reintubation rates, and ICU LOS', 'RSBI', 'Physiologic variables, serial blood gas measurements, and weaning indices', 'Intubation duration', 'late re-intubation rates', 'Early re-intubation (≤48 h) rates', 'hospital LOS']","[{'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C1948041', 'cui_str': 'Surgical and medical procedures'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1112479', 'cui_str': 'Weaning from mechanically assisted ventilation'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C1306577', 'cui_str': 'O/E - dead'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C1112479', 'cui_str': 'Weaning from mechanically assisted ventilation'}, {'cui': 'C1828139', 'cui_str': 'Trial for spontaneous breathing'}, {'cui': 'C0035239', 'cui_str': 'Respiratory therapy'}, {'cui': 'C0004379', 'cui_str': 'Driving'}]","[{'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0425488', 'cui_str': 'Rapid shallow breathing'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0429681', 'cui_str': 'Static lung compliance'}, {'cui': 'C0600130', 'cui_str': 'dyne'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0860359', 'cui_str': 'Reintubate'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}]",5502.0,0.0741723,"Intubation duration was longer in the PW group ( P < 0.001), however, hospital LOS was shorter ( P < 0.001).","[{'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Vahedian-Azimi', 'Affiliation': 'Trauma Research Center, Faculty of Nursing, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farshid Rahimi', 'Initials': 'FR', 'LastName': 'Bashar', 'Affiliation': 'Department of Anesthesia and Critical Care, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Mohammad A', 'Initials': 'MA', 'LastName': 'Jafarabadi', 'Affiliation': 'Road Traffic Injury Prevention Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Stahl', 'Affiliation': 'Department of Internal Medicine, Division of Pulmonary, Critical Care, and Sleep Medicine, Vidant Medical Center, East Carolina University Brody School of Medicine, Greenville, NC, USA.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Miller', 'Affiliation': 'Department of Emergency Medicine, Vidant Medical Center, East Carolina University Brody School of Medicine, Greenville, NC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of critical illness and injury science,['10.4103/IJCIIS.IJCIIS_29_20'] 3536,33850829,Intermittent gastric feeds lower insulin requirements without worsening dysglycemia: A pilot randomized crossover trial.,"Introduction We hypothesized that critically ill medical patients would require less insulin when fed intermittently. Methods First, 26 patients were randomized to receive intermittent or continuous gastric feeds. Once at goal nutrition, data were collected for the first 4-hr data collection period. Next, the enteral feed type was switched, goal nutrition was repeated, and a second 4-h data collection period was completed. The primary endpoint was the total amount of insulin infused; secondary endpoints were glucose concentration mean, maximum, minimum, and standard deviation, as well as episodes of hypoglycemia. Results Sixteen of the 26 patients successfully completed the protocol. One patient experienced a large, rapid, and sustained decline in insulin requirement from liver failure, creating a bias of lesser insulin in the intermittent arm; this patient was removed from the analysis. For the remaining 15 patients, the average total amount of insulin infused was 1.4 U/patient/h less following intermittent feeds: P =0.027, 95% confidence interval (0.02, 11.17), and effect size 0.6. Secondary endpoints were statistically similar. Conclusions Critically ill medical patients who require an insulin infusion have a reduced insulin requirement when fed intermittently, whereas dysglycemia metrics are not adversely affected. A larger clinical study is required to confirm these findings.",2020,"Secondary endpoints were statistically similar. ","['Intermittent gastric feeds lower insulin requirements without worsening dysglycemia', 'ill medical patients who require an', '26 patients', 'critically ill medical patients', 'Sixteen of the 26 patients successfully completed the protocol']","['intermittent or continuous gastric feeds', 'insulin infusion']","['average total amount of insulin', 'total amount of insulin infused; secondary endpoints were glucose concentration mean, maximum, minimum, and standard deviation, as well as episodes of hypoglycemia']","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0861023', 'cui_str': 'Insulin low'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C1960636', 'cui_str': 'Dysglycemia'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C4707055', 'cui_str': 'Infuse'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}]",26.0,0.213095,"Secondary endpoints were statistically similar. ","[{'ForeName': 'Tyson J', 'Initials': 'TJ', 'LastName': 'Sjulin', 'Affiliation': 'Department of Pulmonary Medicine, San Antonio Military Medical Center, San Antonio, TX, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Strilka', 'Affiliation': 'Division of Trauma, Critical Care, and Acute Care Surgery, University of Cincinnati Medical Center, Cincinnati, OH, USA.'}, {'ForeName': 'Nikhil A', 'Initials': 'NA', 'LastName': 'Huprikar', 'Affiliation': 'Department of Pulmonary Medicine, San Antonio Military Medical Center, San Antonio, TX, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Cameron', 'Affiliation': 'Department of Nutritional Medicine, San Antonio Military Medical Center, San Antonio, TX, USA.'}, {'ForeName': 'Parker W', 'Initials': 'PW', 'LastName': 'Woody', 'Affiliation': 'Department of Internal Medicine, San Antonio Military Medical Center, San Antonio, TX, USA.'}, {'ForeName': 'Scott B', 'Initials': 'SB', 'LastName': 'Armen', 'Affiliation': 'Division of Trauma, Acute Care and Critical Care Surgery, Pennsylvania State College of Medicine, Hershey, PA, USA.'}]",International journal of critical illness and injury science,['10.4103/IJCIIS.IJCIIS_112_19'] 3537,33850823,Fentanyl and clonidine as adjuncts to a mixture of local anesthetics in potentiating postoperative analgesia in supraclavicular block: A randomized controlled study.,"Background Brachial plexus block is popular for upper limb surgeries as it is effective for postoperative analgesia. Aims The aim of the study was to compare fentanyl and clonidine as adjuncts to a mixture of local anesthetics in potentiating postoperative analgesia in the supraclavicular block. Materials and Methods Sixty patients of the American Society of Anesthesiologist I and II undergoing upper limb surgeries lasting more than 30 min were included and randomly divided into two groups of 30 each. In clonidine (C) group, patients received 10 ml of 0.5% bupivacaine + 20 ml of 2% lignocaine with adrenaline (1:200,000) and 1 μg/kg clonidine diluted till 35 cc with normal saline. In fentanyl (F) group, patients received 10 ml of 0.5% bupivacaine + 20 ml of 2% lignocaine with adrenaline (1:200,000) and 1 μg/kg fentanyl diluted till 35 cc with normal saline. Patients were observed for onset and duration of sensory and motor blockade, duration of analgesia, postoperative pain, and adverse effects. Results The mean onset of sensory block was faster in Group F (8.43 ± 2.897 min) as compared to 13.17 ± 2.451 min in Group C. The difference between the two groups was statistically strongly significant ( P < 0.0001). There was a significant reduction in the onset of motor block in Group F (14.67 ± 1.84 min) compared to (18.17 ± 2.45 min) Group C with P < 0.0001 (statistically strongly significant). There was a significant increase in the duration of analgesia in Group C (16.63 ± 2.04 h) compared to Group F (8.79 ± 1.50 h) with P < 0.0001. There was bradycardia (pulse did not fall below 60) in two patients of Group C (treated with atropine intravenous [i.v.]). Two patients of Group F complained of nausea and vomiting once in the early hours of surgery for which ondansetron i.v. was given. There were no significant side effects in either of the groups. Conclusion Both clonidine and fentanyl establish a good safety profile. Fentanyl ensures a faster onset of sensory and motor blockade, while clonidine ensures a longer duration of sensory and motor blockade as well as prolonged analgesia.",2020,There was a significant increase in the duration of analgesia in Group C (16.63 ± 2.04 h) compared to Group F (8.79 ± 1.50 h) with P < 0.0001.,"['supraclavicular block', 'Sixty patients of the American Society of Anesthesiologist I and II undergoing upper limb surgeries lasting more than 30 min']","['bupivacaine + 20 ml of 2% lignocaine with adrenaline', 'fentanyl and clonidine', 'Fentanyl and clonidine', 'clonidine (C', 'fentanyl (F', 'bupivacaine + 20 ml of 2% lignocaine with adrenaline (1:200,000) and 1 μg/kg fentanyl diluted till 35 cc with normal saline', 'clonidine diluted till 35 cc with normal saline', 'Fentanyl', 'atropine', 'clonidine']","['bradycardia (pulse', 'onset of motor block', 'onset and duration of sensory and motor blockade, duration of analgesia, postoperative pain, and adverse effects', 'mean onset of sensory block', 'nausea and vomiting', 'side effects', 'duration of sensory and motor blockade', 'duration of analgesia']","[{'cui': 'C0394699', 'cui_str': 'Brachial plexus block by supraclavicular approach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0456693', 'cui_str': '/30 min'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0004259', 'cui_str': 'Atropine'}]","[{'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}]",60.0,0.0722407,There was a significant increase in the duration of analgesia in Group C (16.63 ± 2.04 h) compared to Group F (8.79 ± 1.50 h) with P < 0.0001.,"[{'ForeName': 'Anisha', 'Initials': 'A', 'LastName': 'Puri', 'Affiliation': 'Department of Anesthesiology, Maharishi Markandeshwar, Ambala, Haryana, India.'}, {'ForeName': 'Gurchand', 'Initials': 'G', 'LastName': 'Singh', 'Affiliation': 'Department of ENT, Maharishi Markandeshwar, Ambala, Haryana, India.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Madan', 'Affiliation': 'Deparment of Obstetrics and Gynaecology, Government Medical College, Amritsar, Punjab, India.'}]",International journal of critical illness and injury science,['10.4103/IJCIIS.IJCIIS_68_19'] 3538,33850821,3D CT airway evaluation-guided intraluminal placement of endobronchial blocker in pediatric patients: a randomized controlled study.,"Background The aim of the present study was to propose a new approach for 3D computed tomography (CT) airway evaluation-guided endobronchial blocker placement in pediatric patients, and to determine its efficiency in clinical application. Methods A total of 127 pediatric patients aged 0.5-3 years who were scheduled for elective thoracic surgery using one-lung ventilation (OLV) were randomized into the bronchoscopy (BRO) group and the CT group. The degree of lung collapse, postoperative airway mucosal injury, pulmonary infection within 72 h after surgery, and hoarseness after tracheal extubation; duration of postoperative mechanical ventilation, intensive care unit (ICU) stay and hospitalization; success rate of first blocker positioning; and required time and repositioning for successful blocker placement were compared between the 2 groups. Results The degree of lung collapse, postoperative airway mucosal injury, pulmonary infection within 72 h after surgery, and hoarseness after tracheal extubation; duration of postoperative mechanical ventilation, ICU stay and hospitalization; success rate of first blocker positioning; and required time and repositioning for successful blocker placement were similar between the 2 groups (all P>0.05). Conclusions For pediatric patients undergoing surgery with OLV, preoperative 3D CT airway evaluation could be used to guide endobronchial blocker placement, with a blocking efficiency similar to that of BRO-guided blocker placement.",2021,"The degree of lung collapse, postoperative airway mucosal injury, pulmonary infection within 72 h after surgery, and hoarseness after tracheal extubation; duration of postoperative mechanical ventilation, ICU stay and hospitalization; success rate of first blocker positioning; and required time and repositioning for successful blocker placement were similar between the 2 groups (all P>0.05). ","['pediatric patients undergoing surgery with OLV, preoperative 3D CT airway evaluation', 'pediatric patients', '127 pediatric patients aged 0.5-3 years who were scheduled for']","['elective thoracic surgery using one-lung ventilation (OLV', '3D computed tomography (CT) airway evaluation-guided endobronchial blocker placement', '3D CT airway evaluation-guided intraluminal placement of endobronchial blocker', 'bronchoscopy (BRO']","['degree of lung collapse, postoperative airway mucosal injury, pulmonary infection within 72 h after surgery, and hoarseness after tracheal extubation; duration of postoperative mechanical ventilation, intensive care unit (ICU) stay and hospitalization; success rate of first blocker positioning; and required time and repositioning for successful blocker placement', 'degree of lung collapse, postoperative airway mucosal injury, pulmonary infection within 72 h after surgery, and hoarseness after tracheal extubation; duration of postoperative mechanical ventilation, ICU stay and hospitalization; success rate of first blocker positioning; and required time and repositioning for successful blocker placement']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1283161', 'cui_str': 'Endobronchial blocker'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0442115', 'cui_str': 'Intraluminal'}, {'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004144', 'cui_str': 'Atelectasis'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0876973', 'cui_str': 'Infectious disease of lung'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0556030', 'cui_str': 'Repositioning'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",127.0,0.0378049,"The degree of lung collapse, postoperative airway mucosal injury, pulmonary infection within 72 h after surgery, and hoarseness after tracheal extubation; duration of postoperative mechanical ventilation, ICU stay and hospitalization; success rate of first blocker positioning; and required time and repositioning for successful blocker placement were similar between the 2 groups (all P>0.05). ","[{'ForeName': 'Yingyi', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ""Department of Anesthesiology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Le', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Pediatric Surgery, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Jianning', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': ""Department of Radiology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Minting', 'Initials': 'M', 'LastName': 'Zeng', 'Affiliation': ""Department of Anesthesiology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Qianqi', 'Initials': 'Q', 'LastName': 'Qiu', 'Affiliation': ""Department of Anesthesiology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': ""Pediatric Intensive Care Unit, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': ""Department of Anesthesiology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Yonghong', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': ""Department of Anesthesiology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}]",Translational pediatrics,['10.21037/tp-21-33'] 3539,33850756,Retroperitoneoscopic nephrectomy versus open surgery for non-tuberculous pyonephrotic nonfunctioning kidney: a single-center experience.,"Background Patients with obstructive pyonephrotic nonfunctioning kidney (OPNK) often require simple nephrectomy for long-term severe clinical symptoms. We aimed to analyze the outcomes of retroperitoneal laparoscopy versus open surgery for OPNK. Methods The study included clinical data of 69 patients with non-tuberculous OPNK from January 2015 to June 2019 in a single center. The patients were divided into laparoscopic group (LS, N=33) and open surgery group (OS, N=36). Those whose pathological findings were xanthogranulomatous inflammation or tuberculous granuloma were excluded. Statistical analysis compared the two groups in terms of basic demographic characteristics, preoperative laboratory examination results, and intraoperative and postoperative observation indicators. Results The results showed that non-tuberculous OPNK were more common in women (female/male =4:1). Compared with the LS group, patients in the OS group had higher white blood cells (WBC; P=0.010) and neutrophils (P=0.005) counts before surgery. The main clinical symptoms were low back pain, pyuria, and fever; among them, low back pain combined with pyuria was in the majority. More intraoperative hypotension events were observed in the OS group (P=0.007). Notably, subgroup analysis showed larger stone size happened in the OS group (OR 3.538, 95% CI, 1.337, 9.208). No statistical difference was found in the duration of surgery between the two groups while the length of postoperative hospitalization and retroperitoneal drainage, and postoperative blood transfusion rate increased significantly in the OS group. Postoperative use of non-steroidal anti-inflammatory drugs was more common in the LS group, while opioid analgesics were in the OS group (P=0.0006). There was no statistical difference in other complications. Conclusions In conclusion, considering the advantages of LS in terms of postoperative blood transfusion, surgical drainage and length of hospital stay, we recommend it for non-tubercular OPNK when the stone load of pyonephrosis side was less than 280 mm 2 and the preoperative WBC and neutrophil count were within the normal range.",2021,"No statistical difference was found in the duration of surgery between the two groups while the length of postoperative hospitalization and retroperitoneal drainage, and postoperative blood transfusion rate increased significantly in the OS group.","['69 patients with non-tuberculous OPNK from January 2015 to June 2019 in a single center', '\n\n\nPatients with obstructive pyonephrotic nonfunctioning kidney (OPNK']","['retroperitoneal laparoscopy versus open surgery for OPNK', 'LS', 'Retroperitoneoscopic nephrectomy versus open surgery', 'laparoscopic group (LS, N=33) and open surgery']","['duration of surgery', 'larger stone size', 'white blood cells (WBC; P=0.010) and neutrophils', 'low back pain, pyuria, and fever', 'preoperative WBC and neutrophil count', 'length of postoperative hospitalization and retroperitoneal drainage, and postoperative blood transfusion rate', 'postoperative blood transfusion, surgical drainage and length of hospital stay', 'intraoperative hypotension events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0035359', 'cui_str': 'Retroperitoneal'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0027695', 'cui_str': 'Kidney excision'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0034359', 'cui_str': 'Pyuria'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0035359', 'cui_str': 'Retroperitoneal'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1112259', 'cui_str': 'Intraoperative hypotension'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",69.0,0.0777075,"No statistical difference was found in the duration of surgery between the two groups while the length of postoperative hospitalization and retroperitoneal drainage, and postoperative blood transfusion rate increased significantly in the OS group.","[{'ForeName': 'Xinguang', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Tang', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Hailang', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Ejun', 'Initials': 'E', 'LastName': 'Peng', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Xia', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}]",Translational andrology and urology,['10.21037/tau-20-1449'] 3540,33850742,Indocyanine green fluorescence imaging for laparoscopic complex upper urinary tract reconstructions: a comparative study.,"Background To describe our technique for using an intraureteral injection of indocyanine green (ICG) and visualization under near-infrared fluorescence (NIRF) to facilitate challenging upper urinary tract reconstructions (UUTRs) and to present the comparative outcomes. Methods We collected 36 patients who underwent laparoscopic UUTRs between April 2019 and March 2020, and we divided the patients into two groups based on the use of ICG (ICG group and non-ICG group). Demographic characteristics, perioperative outcomes, and functional outcomes were compared between the two groups. Results There were 18 cases in the ICG group and 18 cases in the non-ICG group, respectively. There were no differences in the baseline characteristics between the two groups. The intraoperative time to identification of the ureter (TIU; 20.9±11.7 vs. 30.0±14.6 min, P=0.03) and length of postoperative hospital stay (LPHS; 11.1±3.0 vs. 16.6±10.0 days, P=0.03) were significantly shorter in the ICG group. There was also a trend for lesser time for locating the stricture (43.0±27.9 vs. 55.4±18.6 min, P=0.14) and lower estimated blood loss (EBL) in the ICG group patients (88.3±75.4 vs. 91.7±46.2 mL, P=0.22). During the mean 3.8-month follow-up for the ICG group and the 6.2-month for the non-ICG group, there was a trend for more severe complications in the non-ICG group. Conclusions Visualizing intraureteral ICG under NIRF is useful in challenging UUTRs, allows for rapid ureteral identification and accurate real-time delineation of the ureteral stricture margins, and provides encouraging follow-up outcomes compared with those in the non-ICG group.",2021,There were no differences in the baseline characteristics between the two groups.,"['36 patients who underwent laparoscopic UUTRs between April 2019 and March 2020', 'laparoscopic complex upper urinary tract reconstructions']","['Indocyanine green fluorescence imaging', 'ICG', 'indocyanine green (ICG) and visualization under near-infrared fluorescence (NIRF', 'ICG (ICG group and non-ICG']","['lesser time for locating the stricture', 'length of postoperative hospital stay', 'blood loss (EBL', 'severe complications', 'intraoperative time to identification of the ureter', 'Demographic characteristics, perioperative outcomes, and functional outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1508753', 'cui_str': 'Urinary system structure'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}]","[{'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0430876', 'cui_str': 'Ophthalmic fluorescence imaging'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C1532326', 'cui_str': 'Infra-red'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0041951', 'cui_str': 'Ureteric'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",36.0,0.0513527,There were no differences in the baseline characteristics between the two groups.,"[{'ForeName': 'Weijie', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': 'Department of Urology, Peking University First Hospital, Institute of Urology, Peking University, National Urological Cancer Centre, Beijing, China.'}, {'ForeName': 'Shengwei', 'Initials': 'S', 'LastName': 'Xiong', 'Affiliation': 'Department of Urology, Peking University First Hospital, Institute of Urology, Peking University, National Urological Cancer Centre, Beijing, China.'}, {'ForeName': 'Yucai', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Urology, Peking University First Hospital, Institute of Urology, Peking University, National Urological Cancer Centre, Beijing, China.'}, {'ForeName': 'Dengxiang', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Beijing Jiangong Hospital, Beijing, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Department of Urology, Beijing Jiangong Hospital, Beijing, China.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Hao', 'Affiliation': 'Department of Urology, Peking University First Hospital, Institute of Urology, Peking University, National Urological Cancer Centre, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Peking University First Hospital, Institute of Urology, Peking University, National Urological Cancer Centre, Beijing, China.'}, {'ForeName': 'Kunlin', 'Initials': 'K', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, Peking University First Hospital, Institute of Urology, Peking University, National Urological Cancer Centre, Beijing, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Emergency General Hospital, Beijing, China.'}, {'ForeName': 'Hongjian', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Department of Urology, Beijing Jiangong Hospital, Beijing, China.'}, {'ForeName': 'Xuesong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Peking University First Hospital, Institute of Urology, Peking University, National Urological Cancer Centre, Beijing, China.'}, {'ForeName': 'Liqun', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Department of Urology, Peking University First Hospital, Institute of Urology, Peking University, National Urological Cancer Centre, Beijing, China.'}]",Translational andrology and urology,['10.21037/tau-20-1261'] 3541,33850706,Comparative Evaluation of Mineral Trioxide Aggregate Pulpotomy and Laser-Assisted Mineral Trioxide Aggregate Pulpotomy: An Original Research Article.,"Context and Aim Formocresol has been used as the material of choice (gold standard) for pulpotomy procedures because of the ease of use but was discouraged due to its potential immune sensitization and mutagenic effects. Laser irradiation was first applied for pulpotomy procedure in the year 1985. Recently, diode lasers have been used for pulpotomy in primary teeth and have shown clinical success rates comparable to formocresol. The present in vivo study was carried out to compare the clinical and radiographic success rates of mineral trioxide aggregate (MTA) pulpotomy and diode laser-assisted pulpotomy in human primary molars. Materials and Methods The present study was a randomized clinical trial in design wherein 40 primary teeth requiring pulpotomy treatment which met the selection criteria (clinical and radiographic) were divided into two groups, Group 1 ( n = 20) wherein the pulpotomy was performed with MTA alone and Group 2 ( n = 20) wherein laser-assisted pulpotomy was performed with MTA (L-MTA). The patients were recalled after 3, 6, and 9 months, respectively and evaluated clinically and radiographically. Statistical Analysis Used The data were analyzed using the Statistical Package for the Social Sciences (SPSS) Version 22 (IBM corporation, Washington DC, United States). Descriptive statistics were used to analyze the data while the Pearson's correlation coefficient test was used to analyze the statistical correlation between the overall success rates observed in the clinical and radiographic findings of both the groups. P < 0.05 was considered statistically significant. Results The clinical success rate in the MTA group was 90%, 84.21%, and 88.23% at 3, 6, and 9 months, respectively, with no clinical signs or, symptoms reported at the said follow-up visits while the radiographic success rate was found to be 85%, 84.21%, and 82.3%, respectively. On the contrary, the clinical success rate in the L-MTA group was found to be 95%, 94.74%, and 94.44% at 3, 6, and 9, months, respectively with the radiographic success rate reported being 90%, 89.47%, and 88.89%, respectively. Conclusion The combination of diode laser and MTA yielded better clinical and radiographic success rates over the pulpotomy procedures done with the help of MTA alone, thereby, concluding that lasers may be considered as adjuvant alternatives for vital pulp therapy on human primary teeth.",2021,"The clinical success rate in the MTA group was 90%, 84.21%, and 88.23% at 3, 6, and 9 months, respectively, with no clinical signs or, symptoms reported at the said follow-up visits while the radiographic success rate was found to be 85%, 84.21%, and 82.3%, respectively.","['human primary molars', '40 primary teeth requiring pulpotomy treatment which met the selection criteria (clinical and radiographic']","['MTA', 'mineral trioxide aggregate (MTA) pulpotomy and diode laser-assisted pulpotomy', 'diode laser and MTA', 'diode lasers', 'Mineral Trioxide Aggregate Pulpotomy and Laser-Assisted Mineral Trioxide Aggregate Pulpotomy', 'Laser irradiation', 'MTA alone and Group 2 ( n = 20) wherein laser-assisted pulpotomy was performed with MTA (L-MTA']","['clinical success rate', 'radiographic success rate']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}, {'cui': 'C0034104', 'cui_str': 'Pulpotomy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0242801', 'cui_str': 'Selection Criteria'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}]","[{'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C0253527', 'cui_str': 'mineral trioxide aggregate'}, {'cui': 'C0034104', 'cui_str': 'Pulpotomy'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}]",40.0,0.0106619,"The clinical success rate in the MTA group was 90%, 84.21%, and 88.23% at 3, 6, and 9 months, respectively, with no clinical signs or, symptoms reported at the said follow-up visits while the radiographic success rate was found to be 85%, 84.21%, and 82.3%, respectively.","[{'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Satyarth', 'Affiliation': 'Department of Dentistry, Government Medical College, Bettiah, Bihar, India.'}, {'ForeName': 'Ahmed Mansour', 'Initials': 'AM', 'LastName': 'Alkhamis', 'Affiliation': 'General Dental Practitioner, Ministry of Health, Arar, Kingdom of Saudi Arabia.'}, {'ForeName': 'Hessah Fahad', 'Initials': 'HF', 'LastName': 'Almunahi', 'Affiliation': 'College of Dentistry, Jouf University, Sakaka, Kingdom of Saudi Arabia.'}, {'ForeName': 'Malak Omar', 'Initials': 'MO', 'LastName': 'Abdulaziz Alsuhaymi', 'Affiliation': 'College of Dentistry, Jouf University, Sakaka, Kingdom of Saudi Arabia.'}, {'ForeName': 'Hima Bindu', 'Initials': 'HB', 'LastName': 'Vadde', 'Affiliation': 'Consultant Pedodontist, Midas ENT Head and Neck Super Speciality Hospital, Hyderabad, Telangana, India.'}, {'ForeName': 'S Navaneet', 'Initials': 'SN', 'LastName': 'Senapathi', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Sri Sai Dental College and Research Institute, Srikakulam, Andhra Pradesh, India.'}, {'ForeName': 'Ahmed Omar', 'Initials': 'AO', 'LastName': 'Shami', 'Affiliation': 'Intern, College of Dentistry, Jazan University, Jazan, Kingdom of Saudi Arabia.'}, {'ForeName': 'Reema Fahad', 'Initials': 'RF', 'LastName': 'Aldrewesh', 'Affiliation': 'College of Dentistry, Jouf University, Sakaka, Kingdom of Saudi Arabia.'}, {'ForeName': 'Abhishek Singh', 'Initials': 'AS', 'LastName': 'Nayyar', 'Affiliation': 'Department of Oral Medicine and Radiology, Saraswati Dhanwantari Dental College and Hospital and Post-graduate Research Institute, Parbhani, Maharashtra, India.'}]",Journal of microscopy and ultrastructure,['10.4103/JMAU.JMAU_54_19'] 3542,33850624,The effect of pregabalin on postdural puncture headache among patients undergoing elective cesarean section: A randomized controlled trial.,"Introduction Post-dural puncture headache (PDPH) is one of the most common problems of cesarean section. The present study aimed to evaluate the effect of pregabalin on PDPH among patients undergoing elective cesarean section. Materials and methods This double-blind clinical trial was performed on 136 patients undergoing elective cesarean section referred to Shahid Motahari Teaching Hospital in Urmia in northwestern Iran from February 1 to December 20, 2020. Patients were selected by convenience sampling method and randomly divided into two groups of intervention and control (N = 68 people each group). The presence of PDPH and its severity were recorded in the checklist based on the VAS, and conventional treatments were prescribed in the case of occurrence of the PDPH. The PDPH severity was also assessed by the patient using the 10-cm Visual Analog Scale (VAS). Results The mean age of participants was 27.82 years. A total of 29 people suffered from hypotension. Regarding pain severity, the mean pain score in the intervention group was significantly lower than the control group (p = 0.01). Results also showed that the frequency of PDPH in the intervention group was significantly lower than the placebo group (4.4% vs. 11.8%; p = 0.019). There was no significant difference between intervention and control groups in terms of demographic characteristics (p > 0.05). Conclusion Results of the present study showed the use of oral pregabalin at night before spinal anesthesia in patients undergoing elective cesarean(C-) section had a preventive effect on the severity and incidence of PDPH.",2021,"Regarding pain severity, the mean pain score in the intervention group was significantly lower than the control group (p = 0.01).","['patients undergoing elective cesarean section', '29 people suffered from hypotension', 'patients undergoing elective cesarean(C-) section', '136 patients undergoing elective cesarean section referred to Shahid Motahari Teaching Hospital in Urmia in northwestern Iran from February 1 to December 20, 2020']","['pregabalin', 'placebo', 'oral pregabalin', 'Introduction\n\n\nPost-dural puncture headache (PDPH']","['postdural puncture headache', 'frequency of PDPH', '10-cm Visual Analog Scale (VAS', 'severity and incidence of PDPH', 'demographic characteristics', 'pain severity', 'mean pain score', 'PDPH severity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0270697', 'cui_str': 'Headache following lumbar puncture'}]","[{'cui': 'C0751188', 'cui_str': 'Post dural puncture headache'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0270697', 'cui_str': 'Headache following lumbar puncture'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",136.0,0.0238747,"Regarding pain severity, the mean pain score in the intervention group was significantly lower than the control group (p = 0.01).","[{'ForeName': 'Tohid', 'Initials': 'T', 'LastName': 'Karami', 'Affiliation': 'Department of Anesthesiology, School of Medicine, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Hoshyar', 'Affiliation': 'Department of Anesthesiology, School of Medicine, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Amin Farid', 'Initials': 'AF', 'LastName': 'Jafari', 'Affiliation': 'Department of Anesthesiology, School of Medicine, Urmia University of Medical Sciences, Urmia, Iran.'}]",Annals of medicine and surgery (2012),['10.1016/j.amsu.2021.102226'] 3543,33850612,A Randomized Clinical Trial on the Effect of Biofeedback on Pain and Quality of Life of Patients With Chronic Coccydynia.,"Introduction Pelvic floor muscles dysfunction is one of the most important etiologies of coccydynia; therefore, manual therapies have been proposed as the first line of treatment. The purpose of this study was to investigate the effect of biofeedback as a new approach in the treatment of coccydynia. Methods Thirty women were randomized into two groups. Both groups were injected with the corticosteroid. One group received pelvic floor muscle exercises plus biofeedback while the other group only performed exercises. The patient's pain was measured using the Visual Analog Scale (VAS) in the first visit and after 1, 2, and 6 months of follow-up as well as Dallas pain and SF-36 quality of life questionnaires before and 2 months after the treatment. Results Pain had improved significantly after 1, 2, and 6 months in both groups compared to the baseline. However, the amount of change was not different between the groups at any time interval. The results were the same for the Dallas pain scale and SF-36 quality of life questionnaire. Conclusion Adding biofeedback to pelvic floor muscle exercises did not lead to any further improvement in the management of chronic coccydynia. Further studies with larger sample sizes may reveal the effect of biofeedback more clearly.",2020,"Conclusion Adding biofeedback to pelvic floor muscle exercises did not lead to any further improvement in the management of chronic coccydynia.","['Methods\n\n\nThirty women', 'Patients With Chronic Coccydynia']","['pelvic floor muscle exercises plus biofeedback while the other group only performed exercises', 'corticosteroid', 'Biofeedback']","['Dallas pain and SF-36 quality of life questionnaires', ""patient's pain"", 'Visual Analog Scale (VAS', 'Pain and Quality of Life', 'Dallas pain scale and SF-36 quality of life questionnaire', 'Results\n\n\nPain']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009193', 'cui_str': 'Pain in the coccyx'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",30.0,0.0832982,"Conclusion Adding biofeedback to pelvic floor muscle exercises did not lead to any further improvement in the management of chronic coccydynia.","[{'ForeName': 'Tannaz', 'Initials': 'T', 'LastName': 'Ahadi', 'Affiliation': 'Neuromusculoskeletal Research Center, Firoozgar Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Gholam Reza', 'Initials': 'GR', 'LastName': 'Raissi', 'Affiliation': 'Neuromusculoskeletal Research Center, Firoozgar Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Hosseini', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Sajadi', 'Affiliation': 'Neuromusculoskeletal Research Center, Firoozgar Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Safoora', 'Initials': 'S', 'LastName': 'Ebadi', 'Affiliation': 'Neuromusculoskeletal Research Center, Firoozgar Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Korosh', 'Initials': 'K', 'LastName': 'Mansoori', 'Affiliation': 'Neuromusculoskeletal Research Center, Firoozgar Hospital, Iran University of Medical Sciences, Tehran, Iran.'}]",Basic and clinical neuroscience,['10.32598/bcn.11.6.1553.1'] 3544,33850467,Can a multidisciplinary approach slow renal progression in CKD patients?,"Background : Several randomized controlled trials have examined the benefits of multidisciplinary CKD care on estimated glomerular filtration rate (eGFR). But, the results are inconclusive. Purpose: This study aimed to evaluate whether or not multidisciplinary CKD care was beneficial in terms of CKD progression. Methods : This is a randomized controlled trial and conducted at community hospital, Thailand. The inclusion criteria were patients with age of 18 years or older and diagnosed with up to stage 3b CKD based on the KDIGO guidelines. Eligible patients divided into two groups: intervention and control group. The intervention group received a type of multidisciplinary treatment, while patients in the control group received the standard treatment administered at the outpatient clinic. The primary outcome was eGFR outcomes at three months after enrollment. Results : During the study period, there were 334 patients who met the study criteria. Eligible patients were divided into two groups: intervention (166 patients; 49.70%) and control (168 patients; 50.30%). There were three outcomes that differed significantly between the two groups at 3 months: mean difference of eGFR from baseline, proportion of patients with eGFR decline greater than 4 mL/min/1.73 m 2 , and difference in CKD stage from baseline. A significantly higher percentage of patients in the intervention group experienced CKD improvement by one stage (24.10% vs 5.95%), and a significantly lower percentage experienced decline by one stage (8.43% vs 35.12%) than in the control group. Conclusion : Slower renal progression in patients with up to stage 3b CKD was shown in patients who were treated by a multidisciplinary approach.",2021,"A significantly higher percentage of patients in the intervention group experienced CKD improvement by one stage (24.10% vs 5.95%), and a significantly lower percentage experienced decline by one stage (8.43% vs 35.12%) than in the control group. ","['Eligible patients', 'patients with age of 18 years or older and diagnosed with up to stage 3b CKD based on the KDIGO guidelines', 'Eligible patients divided into two groups', '334 patients who met the study criteria']","['multidisciplinary CKD care', 'intervention and control group']","['CKD improvement', 'renal progression', 'glomerular filtration rate (eGFR', 'eGFR outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517729', 'cui_str': '334'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",334.0,0.0479391,"A significantly higher percentage of patients in the intervention group experienced CKD improvement by one stage (24.10% vs 5.95%), and a significantly lower percentage experienced decline by one stage (8.43% vs 35.12%) than in the control group. ","[{'ForeName': 'Ampornpan', 'Initials': 'A', 'LastName': 'Theeranut', 'Affiliation': 'Department of Adult Nursing, Faculty of Nursing, Khon Kaen University, Khon Kaen, 40002 Thailand.'}, {'ForeName': 'Nonglak', 'Initials': 'N', 'LastName': 'Methakanjanasak', 'Affiliation': 'Department of Adult Nursing, Faculty of Nursing, Khon Kaen University, Khon Kaen, 40002 Thailand.'}, {'ForeName': 'Pattama', 'Initials': 'P', 'LastName': 'Surit', 'Affiliation': 'Department of Adult Nursing, Faculty of Nursing, Khon Kaen University, Khon Kaen, 40002 Thailand.'}, {'ForeName': 'Junto', 'Initials': 'J', 'LastName': 'Srina', 'Affiliation': 'Department of Medicine, Chumpae Hospital, Khon Kaen, 40002Thailand.'}, {'ForeName': 'Dhavee', 'Initials': 'D', 'LastName': 'Sirivongs', 'Affiliation': 'Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, 40002 Thailand.'}, {'ForeName': 'Doangjai', 'Initials': 'D', 'LastName': 'Adisuksodsai', 'Affiliation': 'Department of Medicine, Chumpae Hospital, Khon Kaen, 40002Thailand.'}, {'ForeName': 'Sunee', 'Initials': 'S', 'LastName': 'Lertsinudom', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen, 40002 Thailand.'}, {'ForeName': 'Kittisak', 'Initials': 'K', 'LastName': 'Sawanyawisuth', 'Affiliation': 'Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, 40002 Thailand.'}]",International journal of medical sciences,['10.7150/ijms.53189'] 3545,33850455,"Efficacy of cyclic and extended regimens of ethinylestradiol 0.02 mg -levonorgestrel 0.09 mg for dysmenorrhea: A placebo-controlled, double-blind, randomized trial.","Purpose We aimed to evaluate the efficacy and safety of 28-day Cyclic and 84-day Extended regimens of NPC-16 (ethinylestradiol 0.02 mg plus levonorgestrel 0.09 mg) in patients with dysmenorrhea. Methods This was a placebo-controlled, double-blind, randomized trial conducted in Japan. A total of 251 primary and secondary dysmenorrhea patients were randomly assigned to the NPC-16-Cyclic group, NPC-16-Extended group, or the Placebo group. The primary end point was a comparison of the efficacy and safety of the Cyclic and Extended NPC-16 regimen for the treatment of dysmenorrhea relative to the Placebo. Main findings Significantly greater reductions in total dysmenorrhea score and visual analog scale score were observed in the Cyclic and Extended groups compared with the Placebo group. Compared with the Cyclic regimen as a secondary end point, the Extended regimen exhibited greater efficacy in the treatment of dysmenorrhea over the course of the study period, particularly in patients with severe dysmenorrhea. The incidence of adverse drug reactions (ADRs) was significantly higher in the Cyclic and Extended groups than in the Placebo group. Conclusion The Cyclic and Extended regimens of NPC-16 significantly reduced dysmenorrhea severity compared to placebo. The Extended regimen was superior to cyclic regimen in reducing the dysmenorrhea.",2021,"The incidence of adverse drug reactions (ADRs) was significantly higher in the Cyclic and Extended groups than in the Placebo group. ","['patients with dysmenorrhea', '251 primary and secondary dysmenorrhea patients', 'Japan', 'patients with severe dysmenorrhea', 'mg for dysmenorrhea']","['NPC-16 (ethinylestradiol 0.02\xa0mg plus levonorgestrel', 'placebo', 'NPC-16-Cyclic group, NPC-16-Extended', 'ethinylestradiol 0.02', 'Placebo', 'NPC-16']","['dysmenorrhea severity', 'dysmenorrhea relative', 'efficacy and safety', 'total dysmenorrhea score and visual analog scale score', 'incidence of adverse drug reactions (ADRs', 'dysmenorrhea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0232944', 'cui_str': 'Secondary dysmenorrhea'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C3177413', 'cui_str': 'NPC 16'}, {'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}, {'cui': 'C4517398', 'cui_str': '0.02'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}]",251.0,0.52204,"The incidence of adverse drug reactions (ADRs) was significantly higher in the Cyclic and Extended groups than in the Placebo group. ","[{'ForeName': 'Tasuku', 'Initials': 'T', 'LastName': 'Harada', 'Affiliation': 'Department of Obstetrics and Gynecology Tottori University Faculty of Medicine Yonago Japan.'}, {'ForeName': 'Mikio', 'Initials': 'M', 'LastName': 'Momoeda', 'Affiliation': ""Department of Integrated Women's Health St. Luke's International Hospital Tokyo Japan.""}]",Reproductive medicine and biology,['10.1002/rmb2.12373'] 3546,33850403,"Assessment of the Need for Routine Distolingual Local Anesthetic Infiltration in Addition to Traditional Inferior Alveolar, Lingual and Long Buccal Nerve Blocks in Mandibular Third Molar Extractions.","Background and Objectives Persistent pain during the removal of mandibular third molars is often due to accessory nerve supply causing inadequate local anesthesia. This study aims to assess the requirement of routine distolingual infiltration anesthesia in addition to traditional inferior alveolar, lingual, and long buccal nerve block in mandibular third molar extractions. Methodology Sixty patients requiring mandibular third molar extraction were randomly divided into two equal groups; Group A (Classic inferior alveolar, lingual, and buccal nerve block) and Group B (with an additional 0.2 ml distolingual infiltration). During various steps of the procedure, any complaint of pain was recorded and graded on a subjective Visual Analog Scale (VAS). Results There was no significant difference between the two groups in regard to age ( P = 0.666) and sex ( P = 0.432). And also, no difference was found in angulation ( P = 0.757), class ( P = 0.417) and position ( P = 1.000) of third molars. Mean VAS scores in Group B (0.153) were significantly lower ( P = 0.004) than that of Group A (0.600). VAS scores during procedural steps were significantly lower in Group B during mucoperiosteal elevation ( P = 0.050), bone guttering ( P = 0.037), and tooth splitting ( P = 0.052). Conclusion Routine distolingual infiltration anesthesia, in addition to classic inferior alveolar, lingual, and long buccal nerve block, is recommended for the extraction of mandibular third molars.",2020,There was no significant difference between the two groups in regard to age ( P = 0.666) and sex ( P = 0.432).,['Methodology\n\n\nSixty patients requiring mandibular third molar extraction'],"['Group A (Classic inferior alveolar, lingual, and buccal nerve block) and Group B (with an additional 0.2 ml distolingual infiltration']","['VAS scores', 'subjective Visual Analog Scale (VAS', 'Mean VAS scores', 'complaint of pain']","[{'cui': 'C0969625', 'cui_str': 'methodology'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0228737', 'cui_str': 'Structure of buccal nerve'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",60.0,0.0609286,There was no significant difference between the two groups in regard to age ( P = 0.666) and sex ( P = 0.432).,"[{'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Chandan', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, JSS Dental College and Hospital, Mysuru, Karnataka, India.'}, {'ForeName': 'Sujeeth Kumar', 'Initials': 'SK', 'LastName': 'Shetty', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, JSS Dental College and Hospital, Mysuru, Karnataka, India.'}, {'ForeName': 'Sahith Kumar', 'Initials': 'SK', 'LastName': 'Shetty', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, JSS Dental College and Hospital, Mysuru, Karnataka, India.'}, {'ForeName': 'Vageesh', 'Initials': 'V', 'LastName': 'Bhat', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, JSS Dental College and Hospital, Mysuru, Karnataka, India.'}]",Contemporary clinical dentistry,['10.4103/ccd.ccd_404_19'] 3547,33850402,Evaluation of the Bioactivity of Surface Modified Polyetheretherketone (PEEK) as an Implant Material: An In Vitro Study.,"Purpose The purpose of this study was to evaluate the bioactivity of polyetheretherketone (PEEK) used as an implant material after surface modification by electron beam deposition of titanium. Materials and Methods Twenty-two samples of PEEK were obtained from a single manufacturer, water jet sectioned, and divided randomly into two groups of eleven each (Group I and Group II). Eleven PEEK samples from Group II were coated with Grade II commercially pure titanium by electron beam deposition technique. One representative sample from each group was evaluated for surface roughness, topography and composition using three dimensional surface profilometer, scanning electron microscope coupled with energy dispersive X-ray (SEM-EDX) analysis. Simulated body fluid (SBF) was prepared and calcium (Ca) content in it was quantitatively analyzed by inductively coupled plasma mass spectrometry (ICP-MS) technique. Ten samples from each group were then immersed in SBF for a period of 21 days and amount of calcium depletion was analyzed to determine the bioactivity of two groups. Surface characteristics and elemental composition of immersed samples were analyzed by SEM-EDX and correlated with results of ICP-MS tests. The data obtained were then subjected to statistical analysis using independent t -test. Results Group II samples showed a significant increase in surface roughness compared to Group I ( P < 0.02). There were significant differences in Ca depletion of Group I and Group II samples when compared to preimmersion Ca content ( P < 0.001). When compared between two Groups, Group II samples showed higher Ca depletion ( P < 0.001). Conclusion Within the limitations of this study, it was concluded that PEEK dental implants which were surface modified by electron beam deposition of titanium had enhanced bioactivity when compared to unmodified PEEK. Hence, they can serve as a valuable alternative to conventional dental implant materials.",2020,Group II samples showed a significant increase in surface roughness compared to Group I ( P < 0.02).,['Implant Material'],"['Surface Modified Polyetheretherketone (PEEK', 'polyetheretherketone (PEEK', 'calcium']","['Ca depletion', 'surface roughness']","[{'cui': 'C0440216', 'cui_str': 'Implant material'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0084113', 'cui_str': 'polyetheretherketone'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}]","[{'cui': 'C0595934', 'cui_str': 'Calcium depletion'}, {'cui': 'C0205148', 'cui_str': 'Surface'}]",,0.0121293,Group II samples showed a significant increase in surface roughness compared to Group I ( P < 0.02).,"[{'ForeName': 'Asish', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'The Tamil Nadu DR MGR Medical University, Ragas Dental College and Hospital, Chennai, Tamil Nadu, India.'}, {'ForeName': 'N S', 'Initials': 'NS', 'LastName': 'Azhagarasan', 'Affiliation': 'The Tamil Nadu DR MGR Medical University, Ragas Dental College and Hospital, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Mahadevan', 'Initials': 'M', 'LastName': 'Ravichandran', 'Affiliation': 'The Tamil Nadu DR MGR Medical University, Ragas Dental College and Hospital, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Hariharan', 'Initials': 'H', 'LastName': 'Ramakrishnan', 'Affiliation': 'Department of Prosthodontics and Implantology, Ragas Dental College and Hospital, Chennai, Tamil Nadu, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Jaya Krishnakumar', 'Affiliation': 'The Tamil Nadu DR MGR Medical University, Ragas Dental College and Hospital, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Vallabh', 'Initials': 'V', 'LastName': 'Mahadevan', 'Affiliation': 'The Tamil Nadu DR MGR Medical University, Ragas Dental College and Hospital, Chennai, Tamil Nadu, India.'}]",Contemporary clinical dentistry,['10.4103/ccd.ccd_258_19'] 3548,33850272,Sustained-release isosorbide mononitrate as adjuvant treatment in isolated systolic hypertension in the elderly.,"Hypertension is one of the main cardiovascular risk factors. In the elderly, the most common form is isolated systolic hypertension, a consequence of the increase in arterial stiffness. None of the antihypertensives currently used affects arterial stiffness, whereas nitrates seem to have an effect. The aim of this work was to assess their effect on elderly patients with uncontrolled isolated systolic hypertension, defined as systolic blood pressure over 140 mmHg and diastolic blood pressure under 90 mmHg. The present study is a phase III, randomized, multicenter, double-blind, placebo-controlled clinical trial, conducted at the University Hospital La Princesa in Madrid. Patients of both sexes, aged 65 years or older, with poorly controlled isolated systolic hypertension, were treated with 40-60 mg of sustained-release isosorbide mononitrate or matching placebo for 12 weeks. The main objective was to assess the effect on clinical pulse pressure (PP); in addition, its effect on vascular function was evaluated. Analysis was performed by intention to treat. The study was registered at the European Union Clinical Trials Register (EUDRACT 2012-002988-10) and was funded by the Spanish Ministry of Health. A total of 58 patients with an average age of 77 years were enrolled, 32 were treated with nitrate, and 26 with placebo. No significant differences were found either in PP decline (5.28 vs 7.49 mmHg, p = 0.79) or in other variables, including parameters of vascular function. There were no differences in adverse events. The results of this study have not confirmed the benefit of nitrate treatment in isolated systolic hypertension or the improvement of vascular function.",2021,"No significant differences were found either in PP decline (5.28 vs 7.49 mmHg, p = 0.79) or in other variables, including parameters of vascular function.","['isolated systolic hypertension in the elderly', '58 patients with an average age of 77 years were enrolled, 32 were treated with nitrate, and 26 with', 'elderly patients with uncontrolled isolated systolic hypertension, defined as systolic blood pressure over 140\u2009mmHg and diastolic blood pressure under 90\u2009mmHg', 'University Hospital La Princesa in Madrid', 'Patients of both sexes, aged 65 years or older, with poorly controlled isolated systolic hypertension']","['placebo', '40-60\u2009mg of sustained-release isosorbide mononitrate or matching placebo', 'isosorbide mononitrate']","['adverse events', 'vascular function', 'clinical pulse pressure (PP', 'PP decline']","[{'cui': 'C0745133', 'cui_str': 'Isolated systolic hypertension'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0221155', 'cui_str': 'Systolic hypertension'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0064079', 'cui_str': 'isosorbide mononitrate'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}]",58.0,0.197487,"No significant differences were found either in PP decline (5.28 vs 7.49 mmHg, p = 0.79) or in other variables, including parameters of vascular function.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Abad Pérez', 'Affiliation': 'Internal Medicine Department, University Hospital de Getafe, Carretera de Madrid-Toledo, Madrid, Spain. danielabadperez@hotmail.com.'}, {'ForeName': 'Iluminada', 'Initials': 'I', 'LastName': 'García Polo', 'Affiliation': 'Internal Medicine Department, University Hospital La Princesa, Madrid, Spain.'}, {'ForeName': 'Francisco José', 'Initials': 'FJ', 'LastName': 'Rodríguez Salvanés', 'Affiliation': 'Admision and Documentary Department, University Hospital La Princesa, Madrid, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Bellisco Roncal', 'Affiliation': 'Internal Medicine Department, University Hospital La Princesa, Madrid, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Ibáñez Sanz', 'Affiliation': 'Internal Medicine Department, University Hospital La Princesa, Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Suárez Fernández', 'Affiliation': 'Internal Medicine Department, University Hospital La Princesa, Madrid, Spain.'}]",Journal of human hypertension,['10.1038/s41371-021-00498-4'] 3549,33850231,Intratympanic steroid therapy for Bell's palsy with poor prognostic results.,"In Bell's palsy, electrodiagnosis by electroneurography (ENoG) is widely used to predict a patient's prognosis. The therapeutic options for patients with poor prognostic results remain controversial. Here, we investigated whether early intervention with intratympanic steroid therapy (ITST) is an effective treatment for Bell's palsy patients with poor electrodiagnostic test results (≤ 10% electroneurography value). Patients in the concurrent ITST group (n = 8) received the standard systemic dose of prednisolone (410 mg total) and intratympanic dexamethasone (16.5 mg total) and those in the control group (n = 21) received systemic prednisolone at the standard dose or higher (average dose, 605 ± 27 mg). A year after onset, the recovery rate was higher in the ITST group than in the control group (88% vs 43%, P = 0.044). The average House-Brackmann grade was better in the concurrent ITST group (1.13 ± 0.13 vs 1.71 ± 0.16, P = 0.035). Concurrent ITST improves the facial nerve outcome in patients with poor electroneurography test results, regardless of whether equivalent or lower glucocorticoid doses were administered. This may be ascribed to a neuroprotective effect of ITST due to a higher dose of steroid reaching the lesion due to dexamethasone transfer in the facial nerve.",2021,"The average House-Brackmann grade was better in the concurrent ITST group (1.13 ± 0.13 vs 1.71 ± 0.16, P = 0.035).","['patients with poor prognostic results remain controversial', ""Bell's palsy patients with poor electrodiagnostic test results (≤\u200910% electroneurography value"", 'patients with poor electroneurography']","['Intratympanic steroid therapy', 'ITST', 'systemic prednisolone', 'intratympanic steroid therapy (ITST', 'concurrent ITST', 'intratympanic dexamethasone', 'standard systemic dose of prednisolone', 'Concurrent ITST']","['recovery rate', 'average House-Brackmann grade', 'facial nerve outcome']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0015469', 'cui_str': 'Facial palsy'}, {'cui': 'C0430874', 'cui_str': 'Electrodiagnostic test'}, {'cui': 'C0919612', 'cui_str': 'Electroneurography'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]","[{'cui': 'C1517566', 'cui_str': 'Intratympanic route'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0015462', 'cui_str': 'Facial nerve structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0569456,"The average House-Brackmann grade was better in the concurrent ITST group (1.13 ± 0.13 vs 1.71 ± 0.16, P = 0.035).","[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Inagaki', 'Affiliation': 'Departments of Otolaryngology, Head and Neck Surgery, Nagoya City University, Graduate School of Medical Sciences and Medical School, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, 467-8601, Japan. ainagaki@med.nagoya-cu.ac.jp.'}, {'ForeName': 'Sachiyo', 'Initials': 'S', 'LastName': 'Katsumi', 'Affiliation': 'Departments of Otolaryngology, Head and Neck Surgery, Nagoya City University, Graduate School of Medical Sciences and Medical School, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, 467-8601, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Sekiya', 'Affiliation': 'Departments of Otolaryngology, Head and Neck Surgery, Nagoya City University, Graduate School of Medical Sciences and Medical School, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, 467-8601, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Murakami', 'Affiliation': 'Departments of Otolaryngology, Head and Neck Surgery, Nagoya City University, Graduate School of Medical Sciences and Medical School, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, 467-8601, Japan.'}]",Scientific reports,['10.1038/s41598-021-87551-x'] 3550,33850184,Role of interferon therapy in severe COVID-19: the COVIFERON randomized controlled trial.,"Type 1 Interferons (IFNs) have been associated with positive effects on Coronaviruses. Previous studies point towards the superior potency of IFNβ compared to IFNα against viral infections. We conducted a three-armed, individually-randomized, open-label, controlled trial of IFNβ1a and IFNβ1b, comparing them against each other and a control group. Patients were randomly assigned in a 1:1:1 ratio to IFNβ1a (subcutaneous injections of 12,000 IU on days 1, 3, 6), IFNβ1b (subcutaneous injections of 8,000,000 IU on days 1, 3, 6), or the control group. All three arms orally received Lopinavir/Ritonavir (400 mg/100 mg twice a day for ten days) and a single dose of Hydroxychloroquine 400 mg on the first day. Our utilized primary outcome measure was Time To Clinical Improvement (TTCI) defined as the time from enrollment to discharge or a decline of two steps on the clinical seven-step ordinal scale, whichsoever came first. A total of 60 severely ill patients with positive RT-PCR and Chest CT scans underwent randomization (20 patients to each arm). In the Intention-To-Treat population, IFNβ1a was associated with a significant difference against the control group, in the TTCI; (HR; 2.36, 95% CI 1.10-5.17, P-value = 0.031) while the IFNβ1b indicated no significant difference compared with the control; HR; 1.42, (95% CI 0.63-3.16, P-value = 0.395). The median TTCI for both of the intervention groups was five days vs. seven days for the control group. The mortality was numerically lower in both of the intervention groups (20% in the IFNβ1a group and 30% in the IFNβ1b group vs. 45% in the control group). There were no significant differences between the three arms regarding the adverse events. In patients with laboratory-confirmed SARS-CoV-2 infection, as compared with the base therapeutic regiment, the benefit of a significant reduction in TTCI was observed in the IFNβ1a arm. This finding needs further confirmation in larger studies.Trial Registration Number: ClinicalTrials.gov, NCT04343768. (Submitted: 08/04/2020; First Online: 13/04/2020) (Registration Number: NCT04343768).",2021,"In the Intention-To-Treat population, IFNβ1a was associated with a significant difference against the control group, in the TTCI; (HR; 2.36, 95% CI 1.10-5.17, P-value = 0.031) while the IFNβ1b indicated no significant difference compared with the control; HR; 1.42, (95% CI 0.63-3.16, P-value = 0.395).","['60 severely ill patients with positive RT-PCR and Chest CT scans underwent randomization (20 patients to each arm', 'severe COVID-19']","['IFNβ1a and IFNβ1b', 'Lopinavir/Ritonavir', 'IFNβ1a', 'IFNβ1b', 'Hydroxychloroquine', 'interferon therapy']","['mortality', 'median TTCI', 'adverse events', 'Time To Clinical Improvement (TTCI) defined as the time from enrollment to discharge or a decline of two steps on the clinical seven-step ordinal scale, whichsoever came first', 'TTCI']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0202823', 'cui_str': 'CT of chest'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0279030', 'cui_str': 'Interferon therapy'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0960273', 'cui_str': 'CAME'}]",60.0,0.270976,"In the Intention-To-Treat population, IFNβ1a was associated with a significant difference against the control group, in the TTCI; (HR; 2.36, 95% CI 1.10-5.17, P-value = 0.031) while the IFNβ1b indicated no significant difference compared with the control; HR; 1.42, (95% CI 0.63-3.16, P-value = 0.395).","[{'ForeName': 'Ilad', 'Initials': 'I', 'LastName': 'Alavi Darazam', 'Affiliation': 'Department of Infectious Diseases, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shervin', 'Initials': 'S', 'LastName': 'Shokouhi', 'Affiliation': 'Department of Infectious Diseases, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohamad Amin', 'Initials': 'MA', 'LastName': 'Pourhoseingholi', 'Affiliation': 'Basic and Molecular Epidemiology of Gastrointestinal Disorders Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Sina', 'Initials': 'SS', 'LastName': 'Naghibi Irvani', 'Affiliation': 'Department of Infectious Diseases, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Sina.Irvani@gmail.com.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Mokhtari', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Minoosh', 'Initials': 'M', 'LastName': 'Shabani', 'Affiliation': 'Department of Infectious Diseases, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Amirdosara', 'Affiliation': 'Anesthesiology Research Center Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Parham', 'Initials': 'P', 'LastName': 'Torabinavid', 'Affiliation': 'Student Research Committee, Hamedan University of Medical Sciences, Hamedan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Golmohammadi', 'Affiliation': 'Department of Infectious Diseases, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'SayedPayam', 'Initials': 'S', 'LastName': 'Hashemi', 'Affiliation': 'Department of Infectious Diseases, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Arsalan', 'Initials': 'A', 'LastName': 'Azimi', 'Affiliation': 'Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Jafarazadeh Maivan', 'Affiliation': 'Clinical Research Development Unit, Bohlool Hospital, School of Medicine, Gonabad University of Medical Sciences, Gonabad, Iran.'}, {'ForeName': 'Omidvar', 'Initials': 'O', 'LastName': 'Rezaei', 'Affiliation': 'Skull Base Research Center, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Zali', 'Affiliation': 'Functional Neurosurgery Research Center, Shohada Tajrish Neurosurgical Center of Excellence, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Hajiesmaeili', 'Affiliation': 'Anesthesiology Research Center Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hadiseh', 'Initials': 'H', 'LastName': 'Shabanpour Dehbsneh', 'Affiliation': 'Department of Infectious Diseases, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Hoseyni Kusha', 'Affiliation': 'Department of Infectious Diseases, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Taleb Shoushtari', 'Affiliation': 'Department of Infectious Diseases, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Negar', 'Initials': 'N', 'LastName': 'Khalili', 'Affiliation': 'Department of Infectious Diseases, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Soleymaninia', 'Affiliation': 'Department of Infectious Diseases, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Latif', 'Initials': 'L', 'LastName': 'Gachkar', 'Affiliation': 'Department of Infectious Diseases, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Khoshkar', 'Affiliation': 'Department of Surgery, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Scientific reports,['10.1038/s41598-021-86859-y'] 3551,33850089,Comparing activated brain regions between noisy and conventional galvanic vestibular stimulation using functional magnetic resonance imaging.,"OBJECTIVE Galvanic vestibular stimulation (GVS) enhances vestibular sensory inputs in vestibular afferents. However, it is unclear whether noisy and conventional GVS activate different regions of the brain. The purpose of this study was to investigate the differences in activated brain regions between those two interventions using functional MRI (fMRI). METHODS Twenty-four healthy volunteers who met the inclusion/exclusion criteria were randomly assigned to the noisy GVS or conventional GVS groups. Brain activity was measured during stimulation and compared with that during resting fMRI. This study used a blocked design comprising four task-rest blocks, each consisting of a 30-s period of vestibular stimulation followed by a 30-s period of rest. We evaluated the differences in contrast images between the noisy and conventional GVS groups. RESULTS The noisy GVS group showed significantly increased activation in the vestibular system-related brain regions, including the insula and central operculum. The conventional GVS group showed significant activity in multisensory areas, including the supramarginal gyrus, central operculum and opercular part of the inferior frontal gyrus. Thus, the noisy GVS group showed significantly increased activity in the insula, putamen and central operculum compared with the conventional GVS group. CONCLUSIONS Noisy GVS could increase brain activity in the insular peripheral region compared to conventional GVS. Our results extend the literature about the importance of the stochastic resonance of noise addition for the vestibular system.",2021,"The noisy GVS group showed significantly increased activation in the vestibular system-related brain regions, including the insula and central operculum.","['vestibular afferents', 'Twenty-four healthy volunteers who met the inclusion/exclusion criteria']","['noisy GVS or conventional GVS groups', 'functional MRI (fMRI', 'functional magnetic resonance imaging', 'Galvanic vestibular stimulation (GVS']","['activity in multisensory areas, including the supramarginal gyrus, central operculum and opercular part of the inferior frontal gyrus', 'activity', 'brain activity', 'Brain activity']","[{'cui': 'C0205115', 'cui_str': 'Afferent'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0228214', 'cui_str': 'Structure of supramarginal gyrus'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0228262', 'cui_str': 'Operculum structure'}, {'cui': 'C0262296', 'cui_str': 'Pars Opercularis'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}]",24.0,0.063331,"The noisy GVS group showed significantly increased activation in the vestibular system-related brain regions, including the insula and central operculum.","[{'ForeName': 'Tsubasa', 'Initials': 'T', 'LastName': 'Mitsutake', 'Affiliation': 'Department of Physical Therapy, Faculty of Medical Science, Fukuoka International University of Health and Welfare, Fukuoka.'}, {'ForeName': 'Maiko', 'Initials': 'M', 'LastName': 'Sakamoto', 'Affiliation': 'Division of Medical Education Development, Education and Research Centre for Community Medicine, Faculty of Medicine, Saga University, Saga.'}, {'ForeName': 'Etsuo', 'Initials': 'E', 'LastName': 'Horikawa', 'Affiliation': 'Department of Orthoptics, Faculty of Medical Science, Fukuoka International University of Health and Welfare, Fukuoka, Japan.'}]",Neuroreport,['10.1097/WNR.0000000000001629'] 3552,33850073,"Assessment of Effectiveness of Erbium:Yttrium-Aluminum-Garnet Laser, GentleWave Irradiation, Photodynamic Therapy, and Sodium Hypochlorite in Smear Layer Removal.","AIM AND OBJECTIVE To compare the effectiveness of erbium:yttrium-aluminum-garnet laser, GentleWave irradiation, photodynamic therapy (PDT), and sodium hypochlorite in smear layer removal and dentin permeability with a scanning electron microscope (SEM). MATERIALS AND METHODS Seventy-five recently extracted single-rooted teeth (maxillary second premolars) were randomly divided into 5 groups of 15 each. Group I teeth was the control group in which conventional root canal preparation (RCP) [17% ethylenediaminetetraacetic acid (EDTA)] was done without laser irradiation, group II teeth underwent RCP and GentleWave™ treatment, group III teeth were subjected to Er:YAG laser irradiation, group IV uses low-level 660 nm (PDT), and group V samples were irrigated with 5.25% NaOCl. All samples were viewed under the SEM. Images at the coronal, middle, and apical part of the root canal were obtained at ×1000. A scoring system for smear layer removal and debris removal scoring was used for analysis. RESULTS Smear layer removal was significantly higher at different points (coronal, middle, and apical area) in group I, followed by V, IV, II, and group III in declining order ( p < 0.05). Intercomparison between the groups at different points indicates a significant difference in smear layer removal score between group I and group V at coronal, middle, and apical third. The result was not significant at coronal third and middle third, between group I and V, II and III, II and IV. The result was not significant at apical third between I and V, II and III, and II and IV ( p < 0.05). Ethylenediaminetetraacetic acid and sodium hypochlorite are effective in smear layer removal followed by the Er-YAG laser technique. CONCLUSION Ethylenediaminetetraacetic acid and NaOCl are effective in smear layer removal. Er:YAG laser-activated RCP was comparatively efficient in cleaning the smear layer and opening dentinal tubules. CLINICAL SIGNIFICANCE Er:YAG laser-activated RCP was comparatively efficient in cleaning the smear layer and it can be used for effective removal of smear layer for clinical usage.",2020,"The result was not significant at coronal third and middle third, between group I and V, II and III, II and IV.","['Smear Layer Removal', 'Seventy-five recently extracted single-rooted teeth (maxillary second premolars']","['erbium:yttrium-aluminum-garnet laser, GentleWave irradiation, photodynamic therapy (PDT), and sodium hypochlorite', 'ethylenediaminetetraacetic acid (EDTA', 'YAG laser irradiation, group IV uses low-level 660 nm (PDT), and group V samples were irrigated with 5.25% NaOCl', 'Ethylenediaminetetraacetic acid and NaOCl', 'Erbium:Yttrium-Aluminum-Garnet Laser, GentleWave Irradiation, Photodynamic Therapy, and Sodium Hypochlorite', 'Ethylenediaminetetraacetic acid and sodium hypochlorite', 'RCP and GentleWave™ treatment, group III teeth were subjected to Er', 'conventional root canal preparation (RCP']","['Smear layer removal', 'smear layer removal score']","[{'cui': 'C0085070', 'cui_str': 'Smear Layer'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}]","[{'cui': 'C0014688', 'cui_str': 'Erbium'}, {'cui': 'C0587723', 'cui_str': 'YAG - laser'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0037518', 'cui_str': 'sodium hypochlorite'}, {'cui': 'C0013618', 'cui_str': 'Edetic Acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1522726', 'cui_str': 'Intravenous route'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C0441855', 'cui_str': 'Group V'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0282543', 'cui_str': 'Root canal preparation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0085070', 'cui_str': 'Smear Layer'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",75.0,0.0182768,"The result was not significant at coronal third and middle third, between group I and V, II and III, II and IV.","[{'ForeName': 'Sumit', 'Initials': 'S', 'LastName': 'Dash', 'Affiliation': ""Department of Conservative Dentistry and Endodontics, Institute of Dental Science, Siksha O' Anusandhan, Deemed to be University, Bhubaneswar, Orissa, India.""}, {'ForeName': 'Prabu Ms', 'Initials': 'PM', 'LastName': 'Ismail', 'Affiliation': 'Department of Restorative Dentistry, College of Dentistry, AR Rass Qassim University, Kingdom of Saudi Arabia.'}, {'ForeName': 'Jyotirmay', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopedics, Patna Dental College and Hospital, Patna, Bihar, India, Phone: +91 9334115000, e-mail: drjyothirmaysingh@gmail.com.'}, {'ForeName': 'Muhammad As', 'Initials': 'MA', 'LastName': 'Agwan', 'Affiliation': 'Department of Restorative Dentistry, College of Dentistry, AR Rass Qassim University, Kingdom of Saudi Arabia.'}, {'ForeName': 'Kaarunya', 'Initials': 'K', 'LastName': 'Ravikumar', 'Affiliation': ""Department of Conservative Dentistry and Endodontic, Vinayaka Mission's Sankarachariyar Dental College (Deemed to be University), Salem, Tamil Nadu, India.""}, {'ForeName': 'Thendral', 'Initials': 'T', 'LastName': 'Annadurai', 'Affiliation': 'Private Practitioner, Endodontist and Faculty of Conservative Dentistry, Tamil Nadu, India.'}]",The journal of contemporary dental practice,[] 3553,33849942,"Endoscopic full-thickness plication for the treatment of PPI-dependent GERD: results from a randomised, sham controlled trial.","BACKGROUND The majority of endoscopic antireflux procedures for GERD are cumbersome to use and randomised long-term data are sparse. We conducted such a trial to determine the efficacy and safety of a novel, easy to use endoscopic full-thickness fundoplication (EFTP) device in patients with GERD. DESIGN Patients with proton pump inhibitor (PPI)-dependent GERD were randomised to either EFTP or a sham procedure in 1:1 ratio. The primary endpoint was ≥50% improvement in the health-related quality of life (GERD-HRQL) score at 3 months. Secondary end points included improvement in GERD-HRQL, reflux symptom scores, PPI usage, oesophageal acid exposure and reflux episodes and endoscopic findings at 3, 6 and 12 months. RESULTS Seventy patients were randomised; 35 in each group with a median (IQR) age of 36 (29-42) years, 71.4% males. 70% had non-erosive reflux disease on endoscopy with a mean DeMeester score of 18.9 (±19.93). The mean (±SD) duration of EFTP procedure was 17.4 (±4) min. The primary end point was more frequently achieved in the EFTP group (65.7% vs 2.9%; p<0.001). Median (IQR) % improvement in GERD-HRQL was significantly higher in the EFTP group at 6 (81.4 (60.9-100.0) versus 8.0 (2.2-21.6); p<0.001) and 12 (92.3 (84.4-100.0) versus 9.1 (4.8-36.0); p<0.001) months. In the EFTP group, 62.8% patients were off-PPI at 12 months compared with 11.4% in the sham group (p<0.001). pH-metry parameters partially improved at 3 months, (n=70; total reflux episodes in EFTP arm and non-acid reflux episodes for EFTP vs sham) but not at 12 months (n=27); endoscopic oesophagitis was seen in 0% in the treatment (n=18) and 5 (29.4%) in the control group (n=17) at 12 months. No major procedure-related adverse events were encountered in either group. CONCLUSION EFTP using a novel device is safe and effective in improving quality of life in patients with PPI dependent mostly non-erosive reflux disease at short and long terms; objective parameters showed a limited response rate. TRIAL REGISTRATION NUMBER NCT03322553.",2021,The primary endpoint was ≥50% improvement in the health-related quality of life (GERD-HRQL) score at 3 months.,"['patients with GERD', 'Seventy patients were randomised; 35 in each group with a median (IQR) age of 36 (29-42) years, 71.4% males', 'Patients with proton pump inhibitor (PPI)-dependent GERD', 'PPI-dependent GERD']","['EFTP', 'Endoscopic full-thickness plication', 'endoscopic full-thickness fundoplication (EFTP) device']","['endoscopic oesophagitis', 'quality of life', 'mean (±SD) duration of EFTP procedure', 'efficacy and safety', 'GERD-HRQL, reflux symptom scores, PPI usage, oesophageal acid exposure and reflux episodes and endoscopic findings at 3, 6 and 12 months', 'health-related quality of life (GERD-HRQL) score', 'total reflux episodes', 'adverse events', 'Median (IQR) % improvement in GERD-HRQL', 'pH-metry parameters']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0439809', 'cui_str': 'Full thickness'}, {'cui': 'C0192499', 'cui_str': 'Esophagogastric fundoplasty'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0014868', 'cui_str': 'Esophagitis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439809', 'cui_str': 'Full thickness'}, {'cui': 'C0192499', 'cui_str': 'Esophagogastric fundoplasty'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",70.0,0.217955,The primary endpoint was ≥50% improvement in the health-related quality of life (GERD-HRQL) score at 3 months.,"[{'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Kalapala', 'Affiliation': 'Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, Telangana, India drkalpala@gmail.com.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Karyampudi', 'Affiliation': 'Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, Telangana, India.'}, {'ForeName': 'Zaheer', 'Initials': 'Z', 'LastName': 'Nabi', 'Affiliation': 'Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, Telangana, India.'}, {'ForeName': 'Santosh', 'Initials': 'S', 'LastName': 'Darisetty', 'Affiliation': 'Anaesthesia, Asian Institute of Gastroenterology, Hyderabad, Telangana, India.'}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Jagtap', 'Affiliation': 'Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Ramchandani', 'Affiliation': 'Gastroenterology, Asian Institute of Gastroenetrology, Hyderabad, Andhra Pradesh, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Asian Institute of Gatroenterology, Hyderabad, India.'}, {'ForeName': 'Sundeep', 'Initials': 'S', 'LastName': 'Lakhtakia', 'Affiliation': 'Gastroenterology, Asian Institute of Gastroenetrology, Hyderabad, Andhra Pradesh, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Goud', 'Affiliation': 'Asian Institute of Gastroenterology, Hyderabad, Telangana, India.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Venkat Rao', 'Affiliation': 'Surgical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India.'}, {'ForeName': 'Prateek', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'University of Kansas, Kansas City, Kansas, USA.'}, {'ForeName': 'D Nageshwar', 'Initials': 'DN', 'LastName': 'Reddy', 'Affiliation': 'Asian Healthcare Foundation, Asian Institute of Gastroenterology, Hyderabad, Andhra Pradesh, India.'}]",Gut,['10.1136/gutjnl-2020-321811'] 3554,33849913,The influence of vitamin D on mammographic density: results from CALGB 70806 (Alliance) a randomized clinical trial.,"Current therapies for breast cancer prevention only prevent estrogen receptor positive (Er+) disease and toxicity limits use of these agents. Vitamin D is a potential prevention therapy for both Er+ and Er- disease and is safe with few side effects. This study evaluates the effect of one-year of vitamin D supplementation on mammographic density (MD), a biomarker of breast cancer risk in a multicenter randomized controlled trial. Premenopausal women with > 25% MD and no history of cancer, were randomly assigned to 2000IU of vitamin D or placebo orally daily for 1-year. Change in percent MD was evaluated using Cumulus software after all participants completed treatment. Three hundred women enrolled between 1/2011 and 12/2013 with a mean age of 43 and diverse ethnicity (14% Hispanic, 12% African American [AA]). Supplementation significantly increased vitamin D levels compared to placebo (14.5 ng/mL vs -1.6 ng/mL; p<0.0001) with all participants on the Vitamin D arm achieving vitamin D sufficiency at 12 months. Vitamin D was safe and well tolerated. After adjustment for baseline MD, the mean between-arm difference (vitamin D vs placebo) at 1 year was -0.75 [-.26, 1.76 p=0.56]. A greater effect was seen for women with >50% MD and AA women, although neither reached significance. This randomized controlled trial demonstrated significant improvement in vitamin D levels with 2000 IU for one year, with 100% of supplemented women achieving sufficiency. However, a null effect was seen regarding change in MD for premenopausal women (the primary outcome of the study).",2021,Supplementation significantly increased vitamin D levels compared to placebo (14.5 ng/mL vs -1.6 ng/mL; p<0.0001) with all participants on the Vitamin D arm achieving vitamin D sufficiency at 12 months.,"['Three hundred women enrolled between 1/2011 and 12/2013 with a mean age of 43 and diverse ethnicity (14% Hispanic, 12% African American [AA', 'Premenopausal women with > 25% MD and no history of cancer']","['Vitamin D', 'vitamin D or placebo', 'vitamin D', 'placebo', 'vitamin D supplementation']","['vitamin D sufficiency', 'vitamin D levels', 'safe and well tolerated', 'mammographic density (MD']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1268717', 'cui_str': 'Mammographic breast density'}]",300.0,0.615878,Supplementation significantly increased vitamin D levels compared to placebo (14.5 ng/mL vs -1.6 ng/mL; p<0.0001) with all participants on the Vitamin D arm achieving vitamin D sufficiency at 12 months.,"[{'ForeName': 'Marie E', 'Initials': 'ME', 'LastName': 'Wood', 'Affiliation': 'University of Vermont Medical Center marie.wood@uvm.edu.'}, {'ForeName': 'Heshan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Statistics, Mayo Clinic.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Storrick', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Zahrieh', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'H Carisa', 'Initials': 'HC', 'LastName': 'Le-Petross', 'Affiliation': 'Diagnostic Imaging, Department of Diagnostic Radiology, Division of Diagnostic Imaging, The University of Texas MD Anderson Cancer Center.'}, {'ForeName': 'Sin-Ho', 'Initials': 'SH', 'LastName': 'Jung', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Zekan', 'Affiliation': 'Southeast Clinical Oncology Research Consortium NCORP.'}, {'ForeName': 'M Margaret', 'Initials': 'MM', 'LastName': 'Kemeny', 'Affiliation': 'Cancer, Queens Cancer Center.'}, {'ForeName': 'Jayne R', 'Initials': 'JR', 'LastName': 'Charlamb', 'Affiliation': 'OBGYN, SUNY Upstate.'}, {'ForeName': 'Lili X', 'Initials': 'LX', 'LastName': 'Wang', 'Affiliation': 'Bay Area Tumor Institute.'}, {'ForeName': 'Gary W', 'Initials': 'GW', 'LastName': 'Unzeitig', 'Affiliation': 'Doctors Hospital of Laredo.'}, {'ForeName': 'Candace S', 'Initials': 'CS', 'LastName': 'Johnson', 'Affiliation': 'Executive Office, Roswell Park Cancer Institute.'}, {'ForeName': 'Judy E', 'Initials': 'JE', 'LastName': 'Garber', 'Affiliation': 'Medical Oncology, Dana-Farber Cancer Institute.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Marshall', 'Affiliation': 'Department of Cancer Prevention and Control, Roswell Park Cancer Institute.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Bedrosian', 'Affiliation': 'Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-20-0581'] 3555,33849908,"Effects of wearing a cloth face mask on performance, physiological and perceptual responses during a graded treadmill running exercise test.","OBJECTIVES To (1) determine if wearing a cloth face mask significantly affected exercise performance and associated physiological responses, and (2) describe perceptual measures of effort and participants' experiences while wearing a face mask during a maximal treadmill test. METHODS Randomised controlled trial of healthy adults aged 18-29 years. Participants completed two (with and without a cloth face mask) maximal cardiopulmonary exercise tests (CPETs) on a treadmill following the Bruce protocol. Blood pressure, heart rate, oxygen saturation, exertion and shortness of breath were measured. Descriptive data and physical activity history were collected pretrial; perceptions of wearing face masks and experiential data were gathered immediately following the masked trial. RESULTS The final sample included 31 adults (age=23.2±3.1 years; 14 women/17 men). Data indicated that wearing a cloth face mask led to a significant reduction in exercise time (-01:39±01:19 min/sec, p<0.001), maximal oxygen consumption (VO 2 max) (-818±552 mL/min, p<0.001), minute ventilation (-45.2±20.3 L/min), maximal heart rate (-8.4±17.0 beats per minute, p<0.01) and increased dyspnoea (1.7±2.9, p<0.001). Our data also suggest that differences in SpO 2 and rating of perceived exertion existed between the different stages of the CPET as participant's exercise intensity increased. No significant differences were found between conditions after the 7-minute recovery period. CONCLUSION Cloth face masks led to a 14% reduction in exercise time and 29% decrease in VO 2 max, attributed to perceived discomfort associated with mask-wearing. Compared with no mask, participants reported feeling increasingly short of breath and claustrophobic at higher exercise intensities while wearing a cloth face mask. Coaches, trainers and athletes should consider modifying the frequency, intensity, time and type of exercise when wearing a cloth face mask.",2021,"Compared with no mask, participants reported feeling increasingly short of breath and claustrophobic at higher exercise intensities while wearing a cloth face mask.","['31 adults (age=23.2±3.1 years; 14 women/17 men', 'healthy adults aged 18-29 years']","['cloth face mask) maximal cardiopulmonary exercise tests (CPETs', 'wearing a cloth face mask', 'wearing a face mask during a maximal treadmill test']","['maximal heart rate', 'minute ventilation', 'performance, physiological and perceptual responses', 'dyspnoea', 'maximal oxygen consumption', 'exercise time', 'Blood pressure, heart rate, oxygen saturation, exertion and shortness of breath']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0039717', 'cui_str': 'Textiles'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0087110', 'cui_str': 'Treadmill Test'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",31.0,0.0526253,"Compared with no mask, participants reported feeling increasingly short of breath and claustrophobic at higher exercise intensities while wearing a cloth face mask.","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Driver', 'Affiliation': 'Sports Therapy and Research, Baylor Scott and White Health, Frisco, Texas, USA Simon.Driver@bswhealth.org.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Reynolds', 'Affiliation': 'Sports Therapy and Research, Baylor Scott and White Health, Frisco, Texas, USA.'}, {'ForeName': 'Katelyn', 'Initials': 'K', 'LastName': 'Brown', 'Affiliation': 'Department of Cardiovascular Rehabilitation, Baylor Scott and White Heart and Vascular Hospital, Dallas, Texas, USA.'}, {'ForeName': 'Jakob L', 'Initials': 'JL', 'LastName': 'Vingren', 'Affiliation': 'Kinesiology, Health Promotion and Recreation, University of North Texas, Denton, Texas, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Hill', 'Affiliation': 'Kinesiology, Health Promotion and Recreation, University of North Texas, Denton, Texas, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Bennett', 'Affiliation': 'Biostatistics Core, Baylor Scott and White Research Institute, Dallas, Texas, USA.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Gilliland', 'Affiliation': 'Sports Therapy and Research, Baylor Scott and White Health, Frisco, Texas, USA.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'McShan', 'Affiliation': 'Sports Therapy and Research, Baylor Scott and White Health, Frisco, Texas, USA.'}, {'ForeName': 'Librada', 'Initials': 'L', 'LastName': 'Callender', 'Affiliation': 'Sports Therapy and Research, Baylor Scott and White Health, Frisco, Texas, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Reynolds', 'Affiliation': 'Sports Therapy and Research, Baylor Scott and White Health, Frisco, Texas, USA.'}, {'ForeName': 'Nate', 'Initials': 'N', 'LastName': 'Borunda', 'Affiliation': 'Sports Performance, Sports Academy, Frisco, Texas, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mosolf', 'Affiliation': 'Sports Performance, Sports Academy, Frisco, Texas, USA.'}, {'ForeName': 'Casey', 'Initials': 'C', 'LastName': 'Cates', 'Affiliation': 'Department of Orthopedics, Baylor University Medical Center at Dallas, Dallas, Texas, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Jones', 'Affiliation': 'Department of Orthopedics, Baylor University Medical Center at Dallas, Dallas, Texas, USA.'}]",British journal of sports medicine,['10.1136/bjsports-2020-103758'] 3556,33849856,Cognitive Outcomes after DEXmedetomidine sedation in cardiac surgery: CODEX randomised controlled trial protocol.,"INTRODUCTION Older patients undergoing cardiac surgery carry the highest risk for developing major postoperative neurocognitive disorder (postoperative NCD or P-NCD) with up to 25% incidence 3 months after surgery. P-NCD is associated with significant morbidity, mortality, loss of independence, premature retirement and increased healthcare costs. This multicentre randomised trial is investigating the efficacy of postoperative dexmedetomidine sedation in reducing the incidence of major P-NCD after cardiac surgery compared with standard protocols. CODEX will be the largest interventional trial with major P-NCD as the primary outcome. METHODS AND ANALYSIS CODEX is recruiting patients ≥60 years old, undergoing elective cardiac surgery and without pre-existing major cognitive dysfunction or dementia. Eligible participants are randomised to receive postoperative dexmedetomidine or standard institutional sedation protocols in the intensive care unit. Baseline preoperative cognitive function is assessed with the computer-based Cogstate Brief Battery. The primary outcome, major P-NCD, 3 months after surgery is defined as a decrease in cognitive function ≥1.96 SD below age-matched, non-operative controls. Secondary outcomes include delirium, major P-NCD at 6/12 months, depressive symptoms, mild P-NCD and quality of surgical recovery at 3/6/12 months. The specific diagnostic criteria used in this protocol are consistent with the recommendations for clinical assessment and management of NCD from the Nomenclature Consensus Working Group on perioperative cognitive changes. Intention-to-treat analysis will compare major P-NCD at 3 months between study groups. ETHICS AND DISSEMINATION CODEX was approved by Sunnybrook Health Sciences Centre Research Ethics Board (REB) (Project ID 1743). This will be the first multicentre, randomised controlled trial to assess the efficacy of a pharmacological intervention to reduce the incidence of major P-NCD after cardiac surgery in patients ≥60 years old. Dissemination of the study results will include briefings of key findings and interpretation, conference presentations and peer-reviewed publications. TRIAL REGISTRATION NUMBER NCT04289142.",2021,"This will be the first multicentre, randomised controlled trial to assess the efficacy of a pharmacological intervention to reduce the incidence of major P-NCD after cardiac surgery in patients ≥60 years old.","['patients ≥60 years old', 'cardiac surgery', 'Older patients undergoing', 'Eligible participants', 'patients ≥60 years old, undergoing elective cardiac surgery and without pre-existing major cognitive dysfunction or dementia']","['DEXmedetomidine sedation', 'postoperative dexmedetomidine sedation', 'pharmacological intervention', 'cardiac surgery', 'CODEX', 'postoperative dexmedetomidine or standard institutional sedation protocols']","['morbidity, mortality, loss of independence, premature retirement and increased healthcare costs', 'delirium, major P-NCD at 6/12 months, depressive symptoms, mild P-NCD and quality of surgical recovery', 'cognitive function', 'Cognitive Outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0035345', 'cui_str': 'Retired'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0442752', 'cui_str': 'Distance vision 6/12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.346981,"This will be the first multicentre, randomised controlled trial to assess the efficacy of a pharmacological intervention to reduce the incidence of major P-NCD after cardiac surgery in patients ≥60 years old.","[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesia, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada stephen.choi@sunnybrook.ca.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Jerath', 'Affiliation': 'Department of Anesthesia, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Jones', 'Affiliation': 'Department of Anesthsia and Perioperative Medicine, University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Sinziana', 'Initials': 'S', 'LastName': 'Avramescu', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Djaiani', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Summer', 'Initials': 'S', 'LastName': 'Syed', 'Affiliation': 'Department of Anesthesia, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Tarit', 'Initials': 'T', 'LastName': 'Saha', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Lilia', 'Initials': 'L', 'LastName': 'Kaustov', 'Affiliation': 'Department of Anesthesia, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kiss', 'Affiliation': 'Sunnybrook Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Frédérick', 'Initials': 'F', 'LastName': ""D'Aragon"", 'Affiliation': ""Départment d'anesthésiologie, Université de Sherbrooke, Sherbrooke, Quebec, Canada.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hedlin', 'Affiliation': 'Department of Anesthesiology, Perioperative Medicine and Pain Management, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'Rajamohan', 'Affiliation': 'Department of Anesthesiology, Pharmacology & Therapeutics, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Etienne J', 'Initials': 'EJ', 'LastName': 'Couture', 'Affiliation': 'Department of Anesthesiology and Cardiac Surgical Intensive Care Division, Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Amara', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Department of Anesthesia, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Josiane Cs', 'Initials': 'JC', 'LastName': 'Mapplebeck', 'Affiliation': 'Department of Anesthesia, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Wong', 'Affiliation': 'Department of Anesthesia, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Beverley Anne', 'Initials': 'BA', 'LastName': 'Orser', 'Affiliation': 'Department of Anesthesia, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}]",BMJ open,['10.1136/bmjopen-2020-046851'] 3557,33849853,Feasibility of a ballet-inspired low-impact at-home workout programme for adults with stroke: a mixed-methods exploratory study protocol.,"INTRODUCTION Balancing problems are prominent in stroke survivors with unilateral paresis. Recent evidence supports that dance interventions are associated with significant improvements in gait, stability and walking endurance in people with neurological conditions. The aim of this study is to explore the feasibility of a novel ballet-inspired at-home workout programme (Footprints to Better Balance (FBB)) for stroke survivors. METHODS AND ANALYSIS A mixed-methods exploratory study incorporating a randomised controlled trial and qualitative evaluation will be conducted. We will recruit 40 adults with a first-ever ischaemic or haemorrhagic stroke and mild-moderate lower limb paresis from two acute stroke units. The intervention group will receive usual care plus FBB, an 8-week home-based programme with ballet-inspired workouts underpinned by Bandura's principles of self-efficacy and outcome expectation. FBB will be delivered by trained lay and peer volunteers, with the support of volunteer healthcare professionals. Multiple data will be collected: Recruitment rate, adherence to FBB, semi-structured interviews and questionnaires on outcomes (balance, gait and memory) assessed at baseline and immediately post-intervention. The generalised estimating equations model will be used to compare differential changes on outcomes across time points between the two arms. Qualitative data will be coded and grouped to form themes and subthemes. ETHICS AND DISSEMINATION Ethical approval from the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee has been obtained. All eligible participants will provide written informed consent. Study results will be disseminated via publications in peer-reviewed journals and presentations at international conferences. TRIAL REGISTRATION NUMBER NCT04460794.",2021,"Recent evidence supports that dance interventions are associated with significant improvements in gait, stability and walking endurance in people with neurological conditions.","['adults with stroke', 'stroke survivors', 'stroke survivors with unilateral paresis', 'people with neurological conditions', '40 adults with a first-ever ischaemic or haemorrhagic stroke and mild-moderate lower limb paresis from two acute stroke units']","['novel ballet-inspired at-home workout programme (Footprints to Better Balance (FBB', ""usual care plus FBB, an 8-week home-based programme with ballet-inspired workouts underpinned by Bandura's principles"", 'FBB', 'ballet-inspired low-impact at-home workout programme']","['gait, stability and walking endurance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0018989', 'cui_str': 'Hemiparesis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0030552', 'cui_str': 'Paresis'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0871967', 'cui_str': 'Ballet'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}]",40.0,0.0877949,"Recent evidence supports that dance interventions are associated with significant improvements in gait, stability and walking endurance in people with neurological conditions.","[{'ForeName': 'Suzanne Hoi Shan', 'Initials': 'SHS', 'LastName': 'Lo', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong suzannelo@cuhk.edu.hk.'}, {'ForeName': 'Janita Pak Chun', 'Initials': 'JPC', 'LastName': 'Chau', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Kai Chow', 'Initials': 'KC', 'LastName': 'Choi', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Yeung', 'Affiliation': 'Alice Ho Miu Ling Nethersole Hospital, NT, Hong Kong.'}, {'ForeName': 'Siu Hung', 'Initials': 'SH', 'LastName': 'Li', 'Affiliation': 'North District Hospital, NT, Hong Kong.'}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Demers', 'Affiliation': 'University of Southern California, Los Angeles, California, USA.'}]",BMJ open,['10.1136/bmjopen-2020-045064'] 3558,33849844,"Investigating the Lowest Threshold of Vascular Benefits from LDL Cholesterol Lowering with a PCSK9 mAb Inhibitor (Alirocumab) in Patients with Stable Cardiovascular Disease (INTENSITY-HIGH): protocol and study rationale for a randomised, open label, parallel group, mechanistic study.","INTRODUCTION Elevated low-density lipoprotein cholesterol (LDL-C) is a strong independent risk predictor of cardiovascular (CV) events, while interventions to reduce it remain the only evidence-based approach to reduce CV morbidity and mortality. Secondary prevention statin trials in combination with ezetimibe and/or proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors showed that there is no 'J shaped curve' in LDL-C levels with regard to CV outcomes. The lowest threshold beyond which reduction of LDL-C confers no further CV benefits has not been identified.The INTENSITY-HIGH study seeks to explore physiological mechanisms mediating CV benefits of LDL-C lowering by PCSK9 inhibition in patients with established cardiovascular disease (CVD). The study examines the changes in measures of endothelial function and vascular inflammation imaging following intervention with PCSK9 and against standard of care. METHODS AND ANALYSIS This is a single-centre, randomised, open label, parallel group, mechanistic physiological study. It will include approximately 60 subjects with established CVD, with LDL-C of <4.1 mmol/L on high-intensity statins. All eligible participants will undergo 18-fluorodeoxyglucose positron emission tomography/CT (FDG-PET/CT) scanning of the aorta and carotid arteries, as well as baseline endothelial function assessment. Subsequently, they will be randomised on a 1:1 basis to either alirocumab 150 mg or ezetimibe 10 mg/day. Repeat FDG-PET/CT scan and vascular assessments will be undertaken after 8 weeks of treatment. Any changes in these parameters will be correlated with changes in lipid levels and systemic inflammation biomarkers. ETHICS AND DISSEMINATION The study received a favourable opinion from the Wales Research Ethics Committee 4, was registered on clinicaltrials.gov and conformed to International Conference for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice. The results of this study will be reported through peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER NCT03355027.",2021,"Elevated low-density lipoprotein cholesterol (LDL-C) is a strong independent risk predictor of cardiovascular (CV) events, while interventions to reduce it remain the only evidence-based approach to reduce CV morbidity and mortality.","['60 subjects with established CVD, with LDL-C of <4.1\u2009mmol/L on high-intensity statins', 'Patients with Stable Cardiovascular Disease (INTENSITY-HIGH', 'patients with established cardiovascular disease (CVD']","['18-fluorodeoxyglucose positron emission tomography/CT (FDG-PET/CT) scanning', 'alirocumab 150\u2009mg or ezetimibe', 'LDL-C lowering by PCSK9 inhibition', 'ezetimibe', 'LDL Cholesterol Lowering with a PCSK9 mAb Inhibitor (Alirocumab']","['lipid levels and systemic inflammation biomarkers', 'CV morbidity and mortality', 'Elevated low-density lipoprotein cholesterol (LDL-C']","[{'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C3641247', 'cui_str': 'FDG PET scan'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1174937', 'cui_str': 'PCSK9 protein, human'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}]",,0.13353,"Elevated low-density lipoprotein cholesterol (LDL-C) is a strong independent risk predictor of cardiovascular (CV) events, while interventions to reduce it remain the only evidence-based approach to reduce CV morbidity and mortality.","[{'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Cacciottolo', 'Affiliation': 'Division of Experimental Medicine and Immunotherapeutics (EMIT), University of Cambridge, Cambridge, UK pjc99@medschl.cam.ac.uk.'}, {'ForeName': 'Michalis S', 'Initials': 'MS', 'LastName': 'Kostapanos', 'Affiliation': 'Lipid Clinic, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Hernan Sancho', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Pavey', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Fotini', 'Initials': 'F', 'LastName': 'Kaloyirou', 'Affiliation': 'Division of Experimental Medicine and Immunotherapeutics (EMIT), University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Evangelia', 'Initials': 'E', 'LastName': 'Vamvaka', 'Affiliation': 'Division of Experimental Medicine and Immunotherapeutics (EMIT), University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Helmy', 'Affiliation': 'Division of Experimental Medicine and Immunotherapeutics (EMIT), University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Hubsch', 'Affiliation': 'Division of Experimental Medicine and Immunotherapeutics (EMIT), University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Carmel M', 'Initials': 'CM', 'LastName': 'McEniery', 'Affiliation': 'Division of Experimental Medicine and Immunotherapeutics (EMIT), University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Ian B', 'Initials': 'IB', 'LastName': 'Wilkinson', 'Affiliation': 'Division of Experimental Medicine and Immunotherapeutics (EMIT), University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Cheriyan', 'Affiliation': 'Division of Experimental Medicine and Immunotherapeutics (EMIT), University of Cambridge, Cambridge, UK.'}]",BMJ open,['10.1136/bmjopen-2020-037457'] 3559,33849833,[Timing of HMG supplementation and clinical outcomes of advanced-age patients with diminished ovarian reserve receiving gonadotropin-releasing hormone antagonist protocol].,"OBJECTIVE To assess the effect and timing of human menopausal gonadotropin (HMG) supplementation in advancedage patients with diminished ovarian reserve (DOR) receiving gonadotropin-releasing hormone antagonist protocol. OBJECTIVE A total of 682 patients with DOR aged over 35 years undergoing IVF-ET treatment were included in this study. All the patients underwent a GnRH antagonist protocol, and controlled ovarian stimulation was initiated on day 2-3 of the menstrual cycle with follicle stimulation hormone (FSH). According to the timing of HMG supplementation, the patients were divided into no supplementation group ( n =371) without HMG supplementation; early supplementation group ( n =139), in which daily HMG supplementation started on the first day till the trigger day; and late supplementation group ( n =172), in which HMG supplementation started when the leading follicle reached 10-14 mm in diameter and lasted until the trigger day. The pregnancy outcomes of the patients were compared among the 3 groups. OBJECTIVE The 3 groups showed no significant difference in hCG trigger day E2 and P levels, endometrial thickness, or the number of follicles with comparable fertilization rate and cleavage rate ( P >0.05). Gn dose used was the lowest in no supplementation group, and the average number of oocytes retrieved was significantly smaller in early supplementation group than in late supplementation group ( P < 0.05). The mean number of mature oocytes and embryos available were significantly higher in late supplementation group than in early supplementation group ( P < 0.05). The clinical pregnancy rate of fresh embryo transfer cycle was significantly higher in late supplementation group than in no supplementation group (27.7% vs 45.1%, P < 0.05), but the implantation rate, early miscarriage rate, heterotopic pregnancy rate and live birth rate were comparable among the 3 groups ( P >0.05). No significant differences were found among the 3 groups in the implantation rate, clinical pregnancy rate, early miscarriage rate, heterotopic pregnancy rate or live birth rate of the first frozen-thawed embryo transfer cycle with a freeze-all strategy ( P >0.05). OBJECTIVE HMG supplementation in the middle and late follicular phase can improve the outcomes of controlled ovarian hyperstimulation and increase the clinical pregnancy rate of fresh embryo transfer cycle in advanced-age patients with DOR undergoing GnRH antagonist protocol.",2021,"No significant differences were found among the 3 groups in the implantation rate, clinical pregnancy rate, early miscarriage rate, heterotopic pregnancy rate or live birth rate of the first frozen-thawed embryo transfer cycle with a freeze-all strategy ( P >0.05). ","['advancedage patients with diminished ovarian reserve (DOR) receiving gonadotropin-releasing hormone antagonist protocol', '682 patients with DOR aged over 35 years undergoing IVF-ET treatment', 'advanced-age patients with DOR undergoing GnRH antagonist protocol', 'advanced-age patients with diminished ovarian reserve receiving']","['GnRH antagonist protocol, and controlled ovarian stimulation', 'gonadotropin-releasing hormone antagonist protocol', 'human menopausal gonadotropin (HMG) supplementation', 'HMG supplementation', 'HMG supplementation; early supplementation group']","['mean number of mature oocytes and embryos available', 'implantation rate, early miscarriage rate, heterotopic pregnancy rate and live birth rate', 'implantation rate, clinical pregnancy rate, early miscarriage rate, heterotopic pregnancy rate or live birth rate of the first frozen-thawed embryo transfer cycle with a freeze-all strategy', 'average number of oocytes', 'clinical pregnancy rate of fresh embryo transfer cycle', 'hCG trigger day E2 and P levels, endometrial thickness, or the number of follicles with comparable fertilization rate and cleavage rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C3160898', 'cui_str': 'Controlled ovarian stimulation'}, {'cui': 'C0025326', 'cui_str': 'human menopausal gonadotrophin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C4324508', 'cui_str': 'Early miscarriage'}, {'cui': 'C0269291', 'cui_str': 'Combined pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0449803', 'cui_str': 'Number of oocytes'}, {'cui': 'C0440732', 'cui_str': 'Fresh embryo'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0010813', 'cui_str': 'Cytokinesis'}]",682.0,0.405451,"No significant differences were found among the 3 groups in the implantation rate, clinical pregnancy rate, early miscarriage rate, heterotopic pregnancy rate or live birth rate of the first frozen-thawed embryo transfer cycle with a freeze-all strategy ( P >0.05). ","[{'ForeName': 'X', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.'}]",Nan fang yi ke da xue xue bao = Journal of Southern Medical University,['10.12122/j.issn.1673-4254.2021.03.14'] 3560,33849821,[Mechanism of Ziyin recipe for treatment of ovulatory infertility: a network pharmacology-based study and clinical observations].,"OBJECTIVE To explore the mechanisms of Ziyin recipe for treatment of ovulatory infertility based on network pharmacology analysis and evaluate the clinical efficacy of this recipe. OBJECTIVE TCMSP, PubChem, Genecards, String, Swiss Target Prediction, and Uniprot databases were searched to identify all the action targets of Ziyin recipe and ovulatory infertility to construct the PPI network. Gene ontology (GO) and KEGG pathway enrichment analyses were performed and the ""TCM-active ingredient-target-pathway"" network was constructed using Cytoscape 3.6.0. We also designed a controlled clinical trial to verify the clinical effectiveness of Ziyin recipe. The patients were randomized into 2 groups to receive treatment with Western medicine including CC and HMG (control group) and additional treatment with Ziyin recipe, and the dosage of GN, follicular development days, E 2 level of a single dominant follicle on trigger day, ovulation rate, the rate of LUFS, and clinical pregnancy rate were compared between the two groups. OBJECTIVE We identified 22 active ingredients and 354 targets of action in Ziyin recipe, 791 targets of ovulatory infertility, and 96 common targets of action shared by Ziyin recipe and ovulatory infertility. According to Degree, the key targets included SRC, MAPK1, HSP90aa1, MAPK3, PTPN11, ESR1, Akt1, EGFR, NR3C1 and KNG1. Enrichment analysis of GO biological process showed that Ziyin recipe mainly focused on steroid hormonemediated signaling pathway, oxidation, reduction, and apoptosis. The most significantly enriched signaling pathways included PI3K-Akt signaling pathway, RAP1 signaling pathway, HIF-1 signaling pathway, estrogen signaling pathway, ovarian steroid production, and steroid hormone biosynthesis. The results of the clinical trial showed that Ziyin recipe significantly reduced the dose of GN, accelerated follicle development, increased E 2 level of single dominant follicle on the trigger day, and increased the cycle ovulation rate and pregnancy rate. OBJECTIVE The therapeutic effects of Ziyin recipe are probably mediated through different pathways to promote follicle development, thus improving ovulation rate and clinical pregnancy rate of infertile patients with ovulatory disorders.",2021,"The results of the clinical trial showed that Ziyin recipe significantly reduced the dose of GN, accelerated follicle development, increased E 2 level of single dominant follicle on the trigger day, and increased the cycle ovulation rate and pregnancy rate. ","['infertile patients with ovulatory disorders', '22 active ingredients and 354 targets of action in Ziyin recipe, 791 targets of ovulatory infertility, and 96 common targets of action shared by Ziyin recipe and ovulatory infertility', 'ovulatory infertility']","['Ziyin recipe', 'Western medicine including CC and HMG (control group) and additional treatment with Ziyin recipe', 'Ziyin recipe']","['cycle ovulation rate and pregnancy rate', 'ovulation rate, the rate of LUFS, and clinical pregnancy rate', 'ovulation rate and clinical pregnancy rate', 'dose of GN, accelerated follicle development, increased E 2 level of single dominant follicle']","[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1292749', 'cui_str': 'Has active ingredient'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0600194', 'cui_str': 'Recipes'}, {'cui': 'C0205214', 'cui_str': 'Common'}]","[{'cui': 'C0600194', 'cui_str': 'Recipes'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025326', 'cui_str': 'human menopausal gonadotrophin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]",,0.109983,"The results of the clinical trial showed that Ziyin recipe significantly reduced the dose of GN, accelerated follicle development, increased E 2 level of single dominant follicle on the trigger day, and increased the cycle ovulation rate and pregnancy rate. ","[{'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Luo', 'Affiliation': 'Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, China.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hu', 'Affiliation': 'Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': 'Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, China.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Xia', 'Affiliation': 'Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, China.'}]",Nan fang yi ke da xue xue bao = Journal of Southern Medical University,['10.12122/j.issn.1673-4254.2021.03.02'] 3561,33849753,Randomized controlled study comparing the use of diphencyprone and anthralin in the treatment of extensive chronic alopecia areata.,,2021,,['extensive chronic alopecia areata'],['diphencyprone and anthralin'],[],"[{'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}]","[{'cui': 'C0058379', 'cui_str': 'diphenylcyclopropenone'}, {'cui': 'C0003166', 'cui_str': 'Anthralin'}]",[],,0.0681274,,"[{'ForeName': 'Vanessa Barreto', 'Initials': 'VB', 'LastName': 'Rocha', 'Affiliation': 'Instituto de Assistência Médica do Servidor Público Estadual, São Paulo, SP, Brazil; Hospital do Servidor Municipal de São Paulo, São Paulo, SP, Brazil. Electronic address: vanessabarreto@oi.com.br.'}, {'ForeName': 'Priscila', 'Initials': 'P', 'LastName': 'Kakizaki', 'Affiliation': 'Instituto de Assistência Médica do Servidor Público Estadual, São Paulo, SP, Brazil; Hospital do Servidor Municipal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Donati', 'Affiliation': 'Hospital do Servidor Municipal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Carla Jorge', 'Initials': 'CJ', 'LastName': 'Machado', 'Affiliation': 'Departamento de Saúde Pública, Faculdade de Medicina, Universidade Federal de Minas Gerais, Minas Gerais, MG, Brazil.'}, {'ForeName': 'Mario Cezar', 'Initials': 'MC', 'LastName': 'Pires', 'Affiliation': 'Instituto de Assistência Médica do Servidor Público Estadual, São Paulo, SP, Brazil.'}, {'ForeName': 'Leticia Arsie', 'Initials': 'LA', 'LastName': 'Contin', 'Affiliation': 'Hospital do Servidor Municipal de São Paulo, São Paulo, SP, Brazil.'}]",Anais brasileiros de dermatologia,['10.1016/j.abd.2020.06.018'] 3562,33849723,"An open-label, comparative, single dose, clinical Phase Ⅰ study to assess the safety and immunogenicity of typhoid conjugate vaccine (Vi-CRM197) in healthy Filipino adults.","An injectable typhoid conjugate vaccine (TCV) provides longer-lasting protection, requires fewer doses, and is suitable for children aged >2 years. In addition, TCV is preferred at most ages owing to its improved immunological properties as it overcomes the limitation of Vi polysaccharide vaccines. Here, we assessed the safety, tolerability, and immunogenicity of a TCV, Vi-CRM197, termed EuTCV, in an open-label clinical phase I study in healthy Filipino adults. This study was conducted in 75 healthy adults aged 18-45 years who were randomized in a 1:1:1 ratio based on the vaccines administered: EuTCV (Test), Typbar-TCV® (WHO prequalified vaccine) and Typhim Vi® (Vi polysaccharide vaccine). The study vaccines were administered at a dose of 25 µg of Vi-CRM197 conjugate by intramuscular injection as a single dose to each of the 25 participants/group, and their immunogenicity and overall safety were assessed for 42 days post-vaccination. All study participants (n = 25/group) completed the trial without dropouts. There were no deaths, SAEs, or events leading to premature withdrawal from the study. Anti-Vi IgG antibody titer (geometric mean titer) of EuTCV group on day 42 was 65.325 [95% CI (36.860, 115.771)], which was significantly higher than that of the WHO prequalified TCV [24.795, 95% CI (16.164, 38.033) p = 0.0055] and the Vi polysaccharide vaccine [7.998, 95% CI (3.800, 16.835) p < 0.0001]. Moreover, the seroconversion rate of EuTCV and Typbar-TCV® was 100%, but that of Typhim Vi® was only 84%. The IgG1-3 subclass titers and serum bactericidal assay results in the EuTCV group showed higher and better bactericidal capacity than the other groups. EuTCV was well tolerated and exhibited an acceptable safety profile in the study population. The Vi-CRM197 conjugate dose of 25 μg may be considered effective in terms of efficacy and safety. ClinicalTrials.gov registration number: NCT03956524.",2021,The IgG1-3 subclass titers and serum bactericidal assay results in the EuTCV group showed higher and better bactericidal capacity than the other groups.,"['children aged >2\xa0years', 'healthy Filipino adults', '75 healthy adults aged 18-45\xa0years', 'All study participants (n\xa0=\xa025/group) completed the trial without dropouts']","['EuTCV', 'Vi polysaccharide vaccine', 'Anti-Vi', 'vaccines administered: EuTCV (Test), Typbar-TCV® (WHO prequalified vaccine) and Typhim Vi® (Vi polysaccharide vaccine', 'typhoid conjugate vaccine (Vi-CRM197', 'TCV', 'injectable typhoid conjugate vaccine (TCV']","['bactericidal capacity', 'deaths, SAEs, or events leading to premature withdrawal', 'immunogenicity and overall safety', 'safety, tolerability, and immunogenicity of a TCV, Vi-CRM197, termed EuTCV', 'efficacy and safety', 'seroconversion rate of EuTCV and Typbar-TCV®', 'IgG antibody titer']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1556093', 'cui_str': 'Filipinos'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032594', 'cui_str': 'Polysaccharide'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0041466', 'cui_str': 'Typhoid fever'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0378248', 'cui_str': 'Typhim VI'}, {'cui': 'C0056499', 'cui_str': 'CRM197 (non-toxic variant of diphtheria toxin)'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0041466', 'cui_str': 'Typhoid fever'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0056499', 'cui_str': 'CRM197 (non-toxic variant of diphtheria toxin)'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}]",75.0,0.284535,The IgG1-3 subclass titers and serum bactericidal assay results in the EuTCV group showed higher and better bactericidal capacity than the other groups.,"[{'ForeName': 'Seuk Keun', 'Initials': 'SK', 'LastName': 'Choi', 'Affiliation': 'R&D Center, EuBiologics Co., Ltd., Chuncheon, Republic of Korea; Department of Biotechnology, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'Yeong Ok', 'Initials': 'YO', 'LastName': 'Baik', 'Affiliation': 'R&D Center, EuBiologics Co., Ltd., Chuncheon, Republic of Korea.'}, {'ForeName': 'Chan Wha', 'Initials': 'CW', 'LastName': 'Kim', 'Affiliation': 'Department of Biotechnology, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'Soo Kyung', 'Initials': 'SK', 'LastName': 'Kim', 'Affiliation': 'R&D Center, EuBiologics Co., Ltd., Chuncheon, Republic of Korea.'}, {'ForeName': 'Il Nam', 'Initials': 'IN', 'LastName': 'Oh', 'Affiliation': 'R&D Center, EuBiologics Co., Ltd., Chuncheon, Republic of Korea.'}, {'ForeName': 'Hyeseon', 'Initials': 'H', 'LastName': 'Yoon', 'Affiliation': 'R&D Center, EuBiologics Co., Ltd., Chuncheon, Republic of Korea.'}, {'ForeName': 'Dajung', 'Initials': 'D', 'LastName': 'Yu', 'Affiliation': 'R&D Center, EuBiologics Co., Ltd., Chuncheon, Republic of Korea.'}, {'ForeName': 'Chankyu', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'R&D Center, EuBiologics Co., Ltd., Chuncheon, Republic of Korea. Electronic address: cklee@eubiologics.com.'}]",Vaccine,['10.1016/j.vaccine.2021.03.089'] 3563,33849715,"Optimization of pulmonary function, functional capacity, and quality of life in adolescents with thoracic burns after a 2-month arm cycling exercise programme: A randomized controlled study.","BACKGROUND Burns to the thorax are at high risk for long-term pulmonary complications due to chest muscle contractures and chronic inflammation in both adolescents and young adults. Few studies have investigated the effects of arm cycling exercise in those individuals. For that reason, this study examined pulmonary function, functional capacity, and quality of life (QOL) in adolescents with thoracic burns subsequent to 2-month arm cycling exercise programme. METHODS A single-blinded, two-month randomized prospective controlled study was carried out between July 2019 and March 2020 on thirty adolescents with chest burns aged 11-17 years. They were randomized into two equal groups (n = 15), traditional physiotherapy programme (control group), and arm cycling exercise plus traditonal physiotherapy (arm cycling exercise group) for 2 consecutive months. Forced vital capacity (FVC), forced expiratory volume in one second (FEV1), six-minute walk test (6MWT), and Pediatric Quality of Life Inventory (PedsQL) were measured in both groups at baseline and after 2-month after intervention. RESULTS No statistical significance was detected at baseline between control and arm cycling exercise groups (FVC, p = 0.903, FEV1, p = 0.835, 6MWT, p = 0.817, and PedsQL, p = 0.612). 2 months after intervention showed statistical improvements in the arm cycling exercise group in all measures (FVC, p = 0.001, FEV1, p < 0.0001, 6MWT, p = 0.001, and PedsQL, p = 0.001) however, the control group showed statistical improvements in FVC, p = 0.044 and FEV1, p = 0.024 with non-statistically significant changes in 6MWT, p = 0.145 and PedsQL, p = 0.067. The arm cycling exercise group showed greater improvements than control group in the outcome measures (FVC, p = 0.034, FEV1, p < 0.017, 6MWT, p = 0.037, and PedsQL, p = 0.021). CONCLUSIONS This prospective study clearly demonstrated positive and beneficial influences of two-month arm cycling exercise in the optimization of pulmonary functions, functional performance, and QOL in adolescents suffering from chest burns and thereby eliminating post-burn complications.",2021,"2 months after intervention showed statistical improvements in the arm cycling exercise group in all measures (FVC, p = 0.001, FEV1, p < 0.0001, 6MWT, p = 0.001, and PedsQL, p = 0.001) however, the control group showed statistical improvements in FVC, p = 0.044 and FEV1, p = 0.024 with non-statistically significant changes in 6MWT, p = 0.145 and PedsQL, p = 0.067.","['adolescents with thoracic burns subsequent to 2-month arm cycling exercise programme', 'July 2019 and March 2020 on thirty adolescents with chest burns aged 11-17 years', 'adolescents and young adults', 'adolescents suffering from chest burns and thereby eliminating post-burn complications', 'adolescents with thoracic burns after a 2-month arm cycling exercise programme']","['traditional physiotherapy programme (control group), and arm cycling exercise plus traditonal physiotherapy (arm cycling exercise group', 'cycling exercise']","['pulmonary functions, functional performance, and QOL', 'pulmonary function, functional capacity, and quality of life', 'pulmonary function, functional capacity, and quality of life (QOL', 'Forced vital capacity (FVC), forced expiratory volume in one second (FEV1), six-minute walk test (6MWT), and Pediatric Quality of Life Inventory (PedsQL']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0740396', 'cui_str': 'Chest burning'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",30.0,0.0362257,"2 months after intervention showed statistical improvements in the arm cycling exercise group in all measures (FVC, p = 0.001, FEV1, p < 0.0001, 6MWT, p = 0.001, and PedsQL, p = 0.001) however, the control group showed statistical improvements in FVC, p = 0.044 and FEV1, p = 0.024 with non-statistically significant changes in 6MWT, p = 0.145 and PedsQL, p = 0.067.","[{'ForeName': 'Walid Kamal', 'Initials': 'WK', 'LastName': 'Abdelbasset', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia; Department of Physical Therapy, Kasr Al-Aini Hospital, Cairo University, Giza, Egypt. Electronic address: walidkamal.wr@gmail.com.'}, {'ForeName': 'Shereen H', 'Initials': 'SH', 'LastName': 'Elsayed', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Health and Rehabilitation Sciences, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Nambi', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}, {'ForeName': 'Bader A', 'Initials': 'BA', 'LastName': 'Alqahtani', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}, {'ForeName': 'Ahmad M', 'Initials': 'AM', 'LastName': 'Osailan', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}, {'ForeName': 'Alshimaa R', 'Initials': 'AR', 'LastName': 'Azab', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia; Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Samah A', 'Initials': 'SA', 'LastName': 'Moawd', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia; Department of Physical Therapy for Cardiovascular/Respiratory Disorders and Geriatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Zeinab A', 'Initials': 'ZA', 'LastName': 'Ali', 'Affiliation': 'Department of Physical Therapy for Surgery, Faculty of Physical Therapy, Cairo University, Giza, Egypt; Department of Physical Therapy, College of Applied Medical Sciences in Al-Qurayyat, Jouf University, Saudi Arabia.'}, {'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Verma', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}, {'ForeName': 'Ramadan S', 'Initials': 'RS', 'LastName': 'Hussein', 'Affiliation': 'Department of Internal Medicine, College of Medicine, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}, {'ForeName': 'Marwa M', 'Initials': 'MM', 'LastName': 'Eid', 'Affiliation': 'Department of Physical Therapy for Surgery, Faculty of Physical Therapy, Cairo University, Giza, Egypt; Department of Physical Therapy, College of Applied Medical Sciences, Taif University, Taif, Saudi Arabia.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2021.03.010'] 3564,33849683,Auditory discrimination and frequency modulation learning in schizophrenia patients: amphetamine within-subject dose response and time course.,"BACKGROUND Auditory frequency modulation learning ('auditory learning') is a key component of targeted cognitive training (TCT) for schizophrenia. TCT can be effective in enhancing neurocognition and function in schizophrenia, but such gains require significant time and effort and elude many patients. METHODS As a strategy to increase and/or accelerate TCT-induced clinical gains, we tested the dose- and time-course effects of the pro-attentional drug, amphetamine (AMPH; placebo, 2.5, 5 or 10 mg po; within-subject double-blind, order balanced) on auditory learning in schizophrenia patients [n = 32; M:F = 19:13; age 42.0 years (24-55)]. To understand predictors and/or mechanisms of AMPH-enhanced TCT, we also measured auditory fidelity (words-in-noise (WIN), quick speech-in-noise (QuickSIN)) and neurocognition (MATRICS comprehensive cognitive battery (MCCB)). Some measures were also acquired from age-matched healthy subjects (drug free; n = 10; M:F = 5:5). RESULTS Patients exhibited expected deficits in neurocognition. WIN and QuickSIN performance at low signal intensities was impaired in patients with low v. high MCCB attention/vigilance (A/V) scores; these deficits were corrected by AMPH, maximally at 2.5-5 mg (d's = 0.79-1.29). AMPH also enhanced auditory learning, with maximal effects at 5 mg (d = 0.93), and comparable effects 60 and 210 min post pill. 'Pro-learning' effects of AMPH and AMPH-induced gains in auditory fidelity were most evident in patients with low MCCB A/V scores. CONCLUSIONS These findings advance our understanding of the impact of pro-attentional interventions on auditory information processing and suggest dose- and time-course parameters for studies that assess the ability of AMPH to enhance the clinical benefits of TCT in schizophrenia patients.",2021,"WIN and QuickSIN performance at low signal intensities was impaired in patients with low v. high MCCB attention/vigilance (A/V) scores; these deficits were corrected by AMPH, maximally at 2.5-5 mg (d's = 0.79-1.29).","['patients with low MCCB A/V scores', 'schizophrenia patients', 'schizophrenia patients [n = 32; M:F = 19:13; age 42.0 years (24-55']","['AMPH and AMPH', 'amphetamine (AMPH; placebo', 'TCT', ""Auditory frequency modulation learning ('auditory learning""]","['Auditory discrimination and frequency modulation learning', 'auditory learning', 'AMPH also enhanced auditory learning', 'deficits in neurocognition', 'auditory fidelity', 'auditory fidelity (words-in-noise (WIN), quick speech-in-noise (QuickSIN)) and neurocognition (MATRICS comprehensive cognitive battery (MCCB']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0234747', 'cui_str': 'Sound discrimination'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}]",,0.0377725,"WIN and QuickSIN performance at low signal intensities was impaired in patients with low v. high MCCB attention/vigilance (A/V) scores; these deficits were corrected by AMPH, maximally at 2.5-5 mg (d's = 0.79-1.29).","[{'ForeName': 'Neal R', 'Initials': 'NR', 'LastName': 'Swerdlow', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, USA.'}, {'ForeName': 'Savita G', 'Initials': 'SG', 'LastName': 'Bhakta', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, USA.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Talledo', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Benster', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, USA.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Kotz', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, USA.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Vinogradov', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Minnesota, USA.'}, {'ForeName': 'Juan L', 'Initials': 'JL', 'LastName': 'Molina', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Light', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, USA.'}]",Psychological medicine,['10.1017/S0033291721001239'] 3565,33849658,Improving cognition in severe mental illness by combining cognitive remediation and transcranial direct current stimulation: study protocol for a pragmatic randomized controlled pilot trial (HEADDSET).,"BACKGROUND A fundamental challenge for many people with severe mental illness (SMI) is how to deal with cognitive impairments. Cognitive impairments are common in this population and limit daily functioning. Moreover, neural plasticity in people with SMI appears to be reduced, a factor that might hinder newly learned cognitive skills to sustain. The objective of this pilot trial is to investigate the effects of cognitive remediation (CR) on cognitive and daily functioning in people dependent on residential settings. In addition, transcranial direct current stimulation (tDCS) is used to promote neural plasticity. It is expected that the addition of tDCS can enhance learning and will result in longer-lasting improvements in cognitive and daily functioning. METHODS This is a pragmatic, triple-blinded, randomized, sham-controlled, pilot trial following a non-concurrent multiple baseline design with the participants serving as their own control. We will compare (1) CR to treatment as usual, (2) active/sham tDCS+CR to treatment as usual, and (3) active tDCS+CR to sham tDCS+CR. Clinical relevance, feasibility, and acceptability of the use of CR and tDCS will be evaluated. We will recruit 26 service users aged 18 years or older, with a SMI and dependent on residential facilities. After a 16-week waiting period (treatment as usual), which will serve as a within-subject control condition, participants will be randomized to 16 weeks of twice weekly CR combined with active (N = 13) or sham tDCS (N = 13). Cognitive, functional, and clinical outcome assessments will be performed at baseline, after the control (waiting) period, directly after treatment, and 6-months post-treatment. DISCUSSION The addition of cognitive interventions to treatment as usual may lead to long-lasting improvements in the cognitive and daily functioning of service users dependent on residential facilities. This pilot trial will evaluate whether CR on its own or in combination with tDCS can be a clinically relevant addition to further enhance recovery. In case the results indicate that cognitive performance can be improved with CR, and whether or not tDCS will lead to additional improvement, this pilot trial will be extended to a large randomized multicenter study. TRIAL REGISTRATION Dutch Trial Registry NL7954 . Prospectively registered on August 12, 2019.",2021,The addition of cognitive interventions to treatment as usual may lead to long-lasting improvements in the cognitive and daily functioning of service users dependent on residential facilities.,"['people with SMI', '26 service users aged 18\u2009years or older, with a SMI and dependent on residential facilities', 'participants serving as their own control', 'people dependent on residential settings', 'many people with severe mental illness (SMI']","['cognitive remediation (CR', 'transcranial direct current stimulation (tDCS', 'tDCS', 'CR combined with active (N\u2009=\u200913) or sham tDCS']",['cognitive and daily functioning'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0035186', 'cui_str': 'Residential Facilities'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.0629202,The addition of cognitive interventions to treatment as usual may lead to long-lasting improvements in the cognitive and daily functioning of service users dependent on residential facilities.,"[{'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Poppe', 'Affiliation': 'Department of Rehabilitation, Lentis Psychiatric Institute, Lagerhout E35, 9741 KE, Zuidlaren, The Netherlands.'}, {'ForeName': 'Leonie', 'Initials': 'L', 'LastName': 'Bais', 'Affiliation': 'Department of Rehabilitation, Lentis Psychiatric Institute, Lagerhout E35, 9741 KE, Zuidlaren, The Netherlands.'}, {'ForeName': 'Daniëlle', 'Initials': 'D', 'LastName': 'van Duin', 'Affiliation': 'Trimbos Institute, Utrecht, The Netherlands.'}, {'ForeName': 'Branislava', 'Initials': 'B', 'LastName': 'Ćurčić-Blake', 'Affiliation': 'Department of Biomedical Sciences of Cells and Systems, Cognitive Neuroscience Center, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Gerdina Hendrika Maria', 'Initials': 'GHM', 'LastName': 'Pijnenborg', 'Affiliation': 'Department of Clinical and Developmental Neuropsychology, University of Groningen, Grote Kruisstraat 2/1, 9712 TS, Groningen, The Netherlands.'}, {'ForeName': 'Lisette', 'Initials': 'L', 'LastName': 'van der Meer', 'Affiliation': 'Department of Rehabilitation, Lentis Psychiatric Institute, Lagerhout E35, 9741 KE, Zuidlaren, The Netherlands. l.van.der.meer@rug.nl.'}]",Trials,['10.1186/s13063-021-05230-8'] 3566,33849654,"Accuracy, patient-perceived usability, and acceptance of two symptom checkers (Ada and Rheport) in rheumatology: interim results from a randomized controlled crossover trial.","BACKGROUND Timely diagnosis and treatment are essential in the effective management of inflammatory rheumatic diseases (IRDs). Symptom checkers (SCs) promise to accelerate diagnosis, reduce misdiagnoses, and guide patients more effectively through the health care system. Although SCs are increasingly used, there exists little supporting evidence. OBJECTIVE To assess the diagnostic accuracy, patient-perceived usability, and acceptance of two SCs: (1) Ada and (2) Rheport. METHODS Patients newly presenting to a German secondary rheumatology outpatient clinic were randomly assigned in a 1:1 ratio to complete Ada or Rheport and consecutively the respective other SCs in a prospective non-blinded controlled randomized crossover trial. The primary outcome was the accuracy of the SCs regarding the diagnosis of an IRD compared to the physicians' diagnosis as the gold standard. The secondary outcomes were patient-perceived usability, acceptance, and time to complete the SC. RESULTS In this interim analysis, the first 164 patients who completed the study were analyzed. 32.9% (54/164) of the study subjects were diagnosed with an IRD. Rheport showed a sensitivity of 53.7% and a specificity of 51.8% for IRDs. Ada's top 1 (D1) and top 5 disease suggestions (D5) showed a sensitivity of 42.6% and 53.7% and a specificity of 63.6% and 54.5% concerning IRDs, respectively. The correct diagnosis of the IRD patients was within the Ada D1 and D5 suggestions in 16.7% (9/54) and 25.9% (14/54), respectively. The median System Usability Scale (SUS) score of Ada and Rheport was 75.0/100 and 77.5/100, respectively. The median completion time for both Ada and Rheport was 7.0 and 8.5 min, respectively. Sixty-four percent and 67.1% would recommend using Ada and Rheport to friends and other patients, respectively. CONCLUSIONS While SCs are well accepted among patients, their diagnostic accuracy is limited to date. TRIAL REGISTRATION DRKS.de, DRKS00017642 . Registered on 23 July 2019.",2021,Rheport showed a sensitivity of 53.7% and a specificity of 51.8% for IRDs.,"['164 patients who completed the study were analyzed', 'Patients newly presenting to a German secondary rheumatology outpatient clinic']",['complete Ada or Rheport and consecutively the respective other SCs'],"['diagnostic accuracy, patient-perceived usability, and acceptance of two SCs: (1) Ada and (2) Rheport', 'Accuracy, patient-perceived usability, and acceptance of two symptom checkers (Ada and Rheport', 'patient-perceived usability, acceptance, and time to complete the SC', 'median completion time', 'accuracy of the SCs regarding the diagnosis of an IRD', 'median System Usability Scale (SUS) score of Ada and Rheport']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0001457', 'cui_str': 'Adenosine deaminase'}, {'cui': 'C0175699', 'cui_str': 'Saethre-Chotzen syndrome'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0175699', 'cui_str': 'Saethre-Chotzen syndrome'}, {'cui': 'C0001457', 'cui_str': 'Adenosine deaminase'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.142944,Rheport showed a sensitivity of 53.7% and a specificity of 51.8% for IRDs.,"[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Knitza', 'Affiliation': 'Department of Internal Medicine 3, Friedrich-Alexander-University Erlangen-Nürnberg (FAU) and Universitätsklinikum Erlangen, Ulmenweg 18, 91054, Erlangen, Germany. johannes.knitza@uk-erlangen.de.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Mohn', 'Affiliation': 'Department of Internal Medicine 3, Friedrich-Alexander-University Erlangen-Nürnberg (FAU) and Universitätsklinikum Erlangen, Ulmenweg 18, 91054, Erlangen, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Bergmann', 'Affiliation': 'Department of Internal Medicine 3, Friedrich-Alexander-University Erlangen-Nürnberg (FAU) and Universitätsklinikum Erlangen, Ulmenweg 18, 91054, Erlangen, Germany.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Kampylafka', 'Affiliation': 'Department of Internal Medicine 3, Friedrich-Alexander-University Erlangen-Nürnberg (FAU) and Universitätsklinikum Erlangen, Ulmenweg 18, 91054, Erlangen, Germany.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Hagen', 'Affiliation': 'Department of Internal Medicine 3, Friedrich-Alexander-University Erlangen-Nürnberg (FAU) and Universitätsklinikum Erlangen, Ulmenweg 18, 91054, Erlangen, Germany.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Bohr', 'Affiliation': 'Department of Internal Medicine 3, Friedrich-Alexander-University Erlangen-Nürnberg (FAU) and Universitätsklinikum Erlangen, Ulmenweg 18, 91054, Erlangen, Germany.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Morf', 'Affiliation': 'Department of Internal Medicine 3, Friedrich-Alexander-University Erlangen-Nürnberg (FAU) and Universitätsklinikum Erlangen, Ulmenweg 18, 91054, Erlangen, Germany.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Araujo', 'Affiliation': 'Department of Internal Medicine 3, Friedrich-Alexander-University Erlangen-Nürnberg (FAU) and Universitätsklinikum Erlangen, Ulmenweg 18, 91054, Erlangen, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Englbrecht', 'Affiliation': 'Department of Internal Medicine 3, Friedrich-Alexander-University Erlangen-Nürnberg (FAU) and Universitätsklinikum Erlangen, Ulmenweg 18, 91054, Erlangen, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Simon', 'Affiliation': 'Department of Internal Medicine 3, Friedrich-Alexander-University Erlangen-Nürnberg (FAU) and Universitätsklinikum Erlangen, Ulmenweg 18, 91054, Erlangen, Germany.'}, {'ForeName': 'Arnd', 'Initials': 'A', 'LastName': 'Kleyer', 'Affiliation': 'Department of Internal Medicine 3, Friedrich-Alexander-University Erlangen-Nürnberg (FAU) and Universitätsklinikum Erlangen, Ulmenweg 18, 91054, Erlangen, Germany.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Meinderink', 'Affiliation': 'Department of Internal Medicine 3, Friedrich-Alexander-University Erlangen-Nürnberg (FAU) and Universitätsklinikum Erlangen, Ulmenweg 18, 91054, Erlangen, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Vorbrüggen', 'Affiliation': 'Verein zur Förderung der Rheumatologie e.V., Würselen, Germany.'}, {'ForeName': 'Cay Benedikt', 'Initials': 'CB', 'LastName': 'von der Decken', 'Affiliation': 'RheumaDatenRhePort (rhadar), Planegg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kleinert', 'Affiliation': 'RheumaDatenRhePort (rhadar), Planegg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ramming', 'Affiliation': 'Department of Internal Medicine 3, Friedrich-Alexander-University Erlangen-Nürnberg (FAU) and Universitätsklinikum Erlangen, Ulmenweg 18, 91054, Erlangen, Germany.'}, {'ForeName': 'Jörg H W', 'Initials': 'JHW', 'LastName': 'Distler', 'Affiliation': 'Department of Internal Medicine 3, Friedrich-Alexander-University Erlangen-Nürnberg (FAU) and Universitätsklinikum Erlangen, Ulmenweg 18, 91054, Erlangen, Germany.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Vuillerme', 'Affiliation': 'Université Grenoble Alpes, AGEIS, Grenoble, France.'}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Fricker', 'Affiliation': 'Qinum GmbH, Cologne, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bartz-Bazzanella', 'Affiliation': 'RheumaDatenRhePort (rhadar), Planegg, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Schett', 'Affiliation': 'Department of Internal Medicine 3, Friedrich-Alexander-University Erlangen-Nürnberg (FAU) and Universitätsklinikum Erlangen, Ulmenweg 18, 91054, Erlangen, Germany.'}, {'ForeName': 'Axel J', 'Initials': 'AJ', 'LastName': 'Hueber', 'Affiliation': 'Department of Internal Medicine 3, Friedrich-Alexander-University Erlangen-Nürnberg (FAU) and Universitätsklinikum Erlangen, Ulmenweg 18, 91054, Erlangen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Welcker', 'Affiliation': 'RheumaDatenRhePort (rhadar), Planegg, Germany.'}]",Arthritis research & therapy,['10.1186/s13075-021-02498-8'] 3567,33849632,Effectiveness of saline water and lidocaine injection treatment of intractable plantar keratoma: a randomised feasibility study.,"BACKGROUND An intractable plantar keratoma (IPK) is a conical thickening of the epidermis' stratum corneum and a common cause of foot pain which can have a significant, detrimental impact on the mobility, quality of life and independence of individuals. Conservative treatments are currently offered to patients with IPK, but they are unsatisfactory since they do not offer a sufficient or permanent reduction of symptoms. The purpose of this study was the evaluation of the feasibility, safety and effectiveness of innovative treatments for intractable plantar keratoma (IPK). METHODS A randomized single blind trial with 40 patients divided with block randomization in four parallel groups was conducted to compare treatment combinations: conservative sharp debridement only or sharp debridement with needle insertion, physiological water injection or lidocaine injection. All patients obtained the same treatment four times at a four-week interval. At each visit, visual analog scale (VAS), Foot Function Index (FFI) and IPK size were evaluated. VAS and FFI were also completed at a six and twelve-month follow-up. RESULTS Our findings in regards to feasibility demonstrated recruitment challenges because of the anticipated pain that would be provoked by needle insertion may not be worth the potential pain relief compared to debridement alone from the patient's perspective. This was also the principal cause of drop out. Our preliminary results show no main effect of group for any of the clinical outcomes: pain felt on VAS, FFI score, IPK's size (p > 0.05). However, the analysis revealed a statistically significant effect of time on VAS (p < 0.001), FFI score (p < 0.001) and IPK's size (width and depth (p < 0.001); length (p = 0.001)), but no group x time interaction was found (p > 0.05). CONCLUSIONS This study demonstrates that IPK treatment consisting of sharp debridement with needle insertion, physiological saline water injection or lidocaine injection is feasible and safe. There was a non-statistically significant trend toward diminishing pain intensity compared to scalpel debridement alone. The pain provoked by needle insertion and injection treatments must be addressed with a scientifically proven protocol to make it more comfortable for patients before these treatments could be considered in further studies. TRIAL REGISTRATION ClinicalTrials.gov, NCT04777227 . 2 March, 2021 - Retrospectively registered (All participants were recruited prior to registration).",2021,"Our preliminary results show no main effect of group for any of the clinical outcomes: pain felt on VAS, FFI score, IPK's size (p > 0.05).","['intractable plantar keratoma', '40 patients divided with block randomization in four parallel groups', '2 March, 2021 - Retrospectively registered (All participants were recruited prior to registration']","['lidocaine injection', 'conservative sharp debridement only or sharp debridement with needle insertion, physiological water injection or lidocaine injection', 'saline water and lidocaine injection']","[""IPK's size (width and depth"", 'feasibility, safety and effectiveness', ""VAS, FFI score, IPK's size"", 'visual analog scale (VAS), Foot Function Index (FFI) and IPK size', 'VAS and FFI', 'pain intensity', 'FFI score', 'time on VAS']","[{'cui': 'C0406159', 'cui_str': 'Intractable plantar keratoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C4049857', 'cui_str': 'Lidocaine Injection'}, {'cui': 'C1444775', 'cui_str': 'Sharp sensation quality'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C4042921', 'cui_str': 'Saline Waters'}]","[{'cui': 'C0406159', 'cui_str': 'Intractable plantar keratoma'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C4706287', 'cui_str': 'Foot Function Index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",40.0,0.153454,"Our preliminary results show no main effect of group for any of the clinical outcomes: pain felt on VAS, FFI score, IPK's size (p > 0.05).","[{'ForeName': 'Marie-Philippe', 'Initials': 'MP', 'LastName': 'Mercier', 'Affiliation': 'Department of Physical Activity Sciences and Podiatric Medicine, Université du Québec à Trois-Rivières, 3351, boul. des Forges, C.P. 500, Trois-Rivières, G9A 5H7, Canada. marie-philippe.mercier@uqtr.ca.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Blanchette', 'Affiliation': 'Department of Physical Activity Sciences and Podiatric Medicine, Université du Québec à Trois-Rivières, 3351, boul. des Forges, C.P. 500, Trois-Rivières, G9A 5H7, Canada.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Cantin', 'Affiliation': 'Department of Physical Activity Sciences and Podiatric Medicine, Université du Québec à Trois-Rivières, 3351, boul. des Forges, C.P. 500, Trois-Rivières, G9A 5H7, Canada.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Brousseau-Foley', 'Affiliation': 'Department of Physical Activity Sciences and Podiatric Medicine, Université du Québec à Trois-Rivières, 3351, boul. des Forges, C.P. 500, Trois-Rivières, G9A 5H7, Canada.'}]",Journal of foot and ankle research,['10.1186/s13047-021-00467-7'] 3568,33849629,"A randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the efficacy and safety of SARS-CoV-2 vaccine (inactivated, Vero cell): a structured summary of a study protocol for a randomised controlled trial.","OBJECTIVES The primary objective is to evaluate the efficacy of an inactivated and aluminium hydroxide adsorbed SARS-CoV-2 vaccine (Sinovac, China) in voluntary participants after 14 days of the second dose against RT-PCR confirmed symptomatic COVID-19 cases. The secondary objectives include evaluating the efficacy after at least one dose of the vaccine against RT-PCR confirmed symptomatic COVID-19 cases; the efficacy of two doses of the vaccine on the rates of hospitalization and death; the safety of the vaccine including adverse reactions up to one year after the 2 nd dose of vaccination; and the immunogenicity of the vaccine and its duration up to 120 days. TRIAL DESIGN This is a phase III, randomized, double-blind, placebo-controlled case driven clinical trial to assess the efficacy and safety of the vaccine. The study is planned to be carried out within two separate cohorts in voluntary participants aged between 18-59 years old. The first cohort includes healthcare professionals actively working in healthcare units, who are assumed to have higher risk of acquiring COVID-19, and the second cohort includes other immunocompetent subjects in the same age group, who are at a regular risk for COVID-19 disease. In Cohort 1, healthcare professionals will be randomized to receive two intramuscular doses of investigational product or the placebo in a 1:1 ratio and they will be monitored for 12 months by active surveillance of COVID-19. In Cohort 2, immunocompetent subjects will be randomized to receive vaccine or the placebo in a 2:1 ratio. PARTICIPANTS Healthcare professionals of both genders, including medical doctors, nurses, cleaners, hospital technicians, and administrative personnel who work in any department of a healthcare unit and immunocompetent individuals of both genders are included. Pregnant (confirmed by positive beta-hCG test) and breastfeeding women as well as those intending to become pregnant within three months after vaccination are excluded. Other exclusion criteria include history of COVID-19 test positivity (PCR or immunoglobulin test results), any form of immunosuppressive therapy including corticosteroids within 6 months, history of bleeding disorders, asplenia, and administration of any form of immunoglobulins or blood products within 3 months. Exclusion criteria for the second dose include any serious adverse events related with the vaccine, anaphylaxis or hypersensitivity after vaccination, or any confirmed or suspected autoimmune or immunosuppressive disease (including HIV infection). Participants are only included after signing the voluntary informed consent form, ensuring cooperation in visits, undergoing screening for evaluation, and conforming to all the inclusion and exclusion criteria. All clinical sites are located in Turkey. INTERVENTION AND COMPARATOR The vaccine was manufactured by Sinovac Research & Development Co., Ltd. It is a preparation made from a novel coronavirus (strain CZ02) grown in the kidney cell cultures (Vero Cell) of the African green monkey and contains inactivated SARS-CoV-2 virus, aluminium hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate, and sodium chloride. A dose of 0.5 mL contains 600 SU of SARS-CoV-2 virus antigen. The placebo contains aluminium hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate, and sodium chloride (0.5mL/dose). Scheduled visits and additional unscheduled weekly visits will be performed for the first 13 weeks and neutralizing antibody test, IgG test, T-Cell activation test, pregnancy test, and RT-PCR tests along with total antibody test will be performed. Adverse events and serious adverse events during the follow-up will be recorded on diary cards. Diary cards will collect information on the timing and severity of COVID-19 symptoms and solicited adverse events recorded by the subjects during one-year follow-up period. All serious adverse events will be managed and necessary treatment will be ensured according to the local regulations. All serious adverse events following vaccination will be reported to the ethics committee, the Ministry of Health, and the study sponsor within 24 hours of detection. MAIN OUTCOMES The primary efficacy endpoint is the incidence of symptomatic cases of COVID-19 disease confirmed by RT-PCR two weeks after the second dose of vaccination. Secondary efficacy endpoints are the incidence of hospitalization/mortality rates among one or two dose regimens, duration of immunogenicity rates up to 120 days, the seroconversion rate, the seropositivity rate, neutralizing antibody titer, and IgG levels 14 days after each dose of vaccination. The primary safety endpoint is the severity and frequency of local and systemic adverse reactions during the period of one week after vaccination. The study would be terminated if more than 15% of the subjects have grade ≥3 adverse events related to vaccination including local reactions. RANDOMISATION Eligible subjects will be randomized at their Study Day 0 to two study groups using an Interactive Web Response System (IWRS; developed by Omega CRO, Ankara, Turkey) in both risk groups. The IWRS system customizes the randomization algorithm. After enrolment in the study, each participant will be randomly assigned to either of the two treatment arms at a ratio of 1:1 in the high-risk group and at a ratio of 2:1 in the normal risk group. Each enrolled participant will be assigned to a code and will receive the treatment labelled with the code. BLINDING (MASKING) The trial is a double-blind study to avoid introducing bias. The blinding may be broken by the investigator in the event of a medical emergency in which knowledge of the identity of the study vaccine is critical for management of the subject's immediate treatment. The Data and Safety Monitoring Board is to be contacted in case of breaking the blinding for a study object. The blood samples will be taken from both placebo and vaccinated groups, in order not to break the blinding. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) The study is planned to be carried out with two separate cohorts. The Cohort 1 includes healthcare professionals working in healthcare units and the Cohort 2 consists of immunocompetent subjects having normal risk for COVID-19 disease. The Cohort 2 will be initiated after the evaluation of the interim safety report of the Cohort 1 by the Data and Safety Monitoring Board. Both cohorts will be followed-up via RT-PCR to confirm symptomatic COVID-19 cases. If the clinical efficacy of the vaccine is shown in the Cohort 1 or 2, the subjects randomized into the placebo arm will also be vaccinated. In the Cohort 1, 588 subjects should be included in both arms with the assumption that the risk of infection with COVID-19 will be 5% for the placebo arm and 2% for the vaccine arm in the high-risk group. Considering 10% of drop-out rate and 5% of seropositivity or PCR positivity at baseline, 680 subjects should be screened at both arms of the Cohort 1. Group sample sizes of 7545 SARS-CoV-2 vaccine and 3773 placebo suits at a two-sided 95% confidence interval for the difference in population proportions with a width equal to 1.0%, when the estimated incidence rate for vaccinated group is 1.0% and the estimated incidence rate for placebo group is 2.0%. Drop-out rate is assumed to be 10% and seropositivity or PCR positivity at baseline is assumed to be 5%; accordingly, 13000 participants are needed to be enrolled totally in both cohorts. The remaining 11640 subjects will be screened in the Cohort 2 and eligible subjects will be randomized at a ratio of 2:1. TRIAL STATUS Protocol version 6.0 - 15 October 2020. Recruitment started on 15.09.2020 and is expected to end on February 2022. TRIAL REGISTRATION ClinicalTrials.gov, NCT04582344 . Registered 8 October 2020 FULL PROTOCOL: The full protocol of the trial is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2021,"Exclusion criteria for the second dose include any serious adverse events related with the vaccine, anaphylaxis or hypersensitivity after vaccination, or any confirmed or suspected autoimmune or immunosuppressive disease (including HIV infection).","['immunocompetent subjects having normal risk for COVID-19 disease', 'Registered 8 October 2020', '13000 participants are needed to be enrolled totally in both cohorts', 'Protocol version 6.0 - 15 October 2020', 'Healthcare professionals of both genders, including medical doctors, nurses, cleaners, hospital technicians, and administrative personnel who work in any department of a healthcare unit and immunocompetent individuals of both genders are included', '588 subjects', 'voluntary participants after 14 days of the second dose against RT-PCR confirmed symptomatic COVID-19 cases', '11640 subjects will be screened in the Cohort 2 and eligible subjects', 'two separate cohorts in voluntary participants aged between 18-59 years old']","['aluminium hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate, and sodium chloride', 'placebo contains aluminium hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate, and sodium chloride', 'placebo', 'Interactive Web Response System (IWRS; developed by Omega CRO, Ankara, Turkey', 'inactivated and aluminium hydroxide adsorbed SARS-CoV-2 vaccine (Sinovac, China', 'vaccine', 'SARS-CoV-2 vaccine (inactivated, Vero cell']","['duration of immunogenicity rates', 'incidence of hospitalization/mortality rates', 'risk of infection with COVID-19', 'Adverse events and serious adverse events', 'efficacy and safety', 'severity and frequency of local and systemic adverse reactions', 'rates of hospitalization and death', 'adverse reactions', 'seroconversion rate, the seropositivity rate, neutralizing antibody titer, and IgG levels', 'seropositivity or PCR positivity', 'incidence of symptomatic cases of COVID-19 disease confirmed by RT-PCR', 'neutralizing antibody test, IgG test, T-Cell activation test, pregnancy test, and RT-PCR tests']","[{'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0001568', 'cui_str': 'Administrative Personnel'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0002371', 'cui_str': 'Aluminum Hydroxide'}, {'cui': 'C0772024', 'cui_str': 'Sodium Phosphate, Dibasic'}, {'cui': 'C0770578', 'cui_str': 'Sodium Phosphate, Monobasic'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1719844', 'cui_str': 'Omega'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0042542', 'cui_str': 'Vero Cells'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0201781', 'cui_str': 'Activation test'}, {'cui': 'C0032976', 'cui_str': 'Pregnancy detection examination'}]",13000.0,0.795859,"Exclusion criteria for the second dose include any serious adverse events related with the vaccine, anaphylaxis or hypersensitivity after vaccination, or any confirmed or suspected autoimmune or immunosuppressive disease (including HIV infection).","[{'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Akova', 'Affiliation': 'Department of Infectious Diseases and Clinical Microbiology, Hacettepe University School of Medicine, Hacettepe Mh., 06230, Ankara, Turkey. makova@hacettepe.edu.tr.'}, {'ForeName': 'Serhat', 'Initials': 'S', 'LastName': 'Unal', 'Affiliation': 'Department of Infectious Diseases and Clinical Microbiology, Hacettepe University School of Medicine, Hacettepe Mh., 06230, Ankara, Turkey.'}]",Trials,['10.1186/s13063-021-05180-1'] 3569,33849618,"Negative drift of sedation depth in critically ill patients receiving constant minimum alveolar concentration of isoflurane, sevoflurane, or desflurane: a randomized controlled trial.","BACKGROUND Intensive care unit (ICU) physicians have extended the minimum alveolar concentration (MAC) to deliver and monitor long-term volatile sedation in critically ill patients. There is limited evidence of MAC's reliability in controlling sedation depth in this setting. We hypothesized that sedation depth, measured by the electroencephalography (EEG)-derived Narcotrend-Index (burst-suppression N_Index 0-awake N_Index 100), might drift downward over time despite constant MAC values. METHODS This prospective single-centre randomized clinical study was conducted at a University Hospital Surgical Intensive Care Unit and included consecutive, postoperative ICU patients fulfilling the inclusion criteria. Patients were randomly assigned to receive uninterrupted inhalational sedation with isoflurane, sevoflurane, or desflurane. The end-expiratory concentration of the anaesthetics and the EEG-derived index were measured continuously in time-stamped pairs. Sedation depth was also monitored using Richmond-Agitation-Sedation-Scale (RASS). The paired t-test and linear models (bootstrapped or multilevel) have been employed to analyze MAC, N_Index and RASS across the three groups. RESULTS Thirty patients were recruited (female/male: 10/20, age 64 ± 11, Simplified Acute Physiology Score II 30 ± 10). In the first 24 h, 21.208 pairs of data points (N_Index and MAC) were recorded. The median MAC of 0.58 ± 0.06 remained stable over the sedation time in all three groups. The t-test indicated in the isoflurane and sevoflurane groups a significant drop in RASS and EEG-derived N_Index in the first versus last two sedation hours. We applied a multilevel linear model on the entire longitudinal data, nested per patient, which produced the formula N_Index = 43 - 0.7·h (R 2  = 0.76), showing a strong negative correlation between sedation's duration and the N_Index. Bootstrapped linear models applied for each sedation group produced: N_Index of 43-0.9, 45-0.8, and 43-0.4·h for isoflurane, sevoflurane, and desflurane, respectively. The regression coefficient for desflurane was almost half of those for isoflurane and sevoflurane, indicating a less pronounced time-effect in this group. CONCLUSIONS Maintaining constant MAC does not guarantee stable sedation depth. Thus, the patients necessitate frequent clinical assessments or, when unfeasible, continuous EEG monitoring. The differences across different volatile anaesthetics regarding their time-dependent negative drift requires further exploration. TRIAL REGISTRATION NCT03860129.",2021,The t-test indicated in the isoflurane and sevoflurane groups a significant drop in RASS and EEG-derived N_Index in the first versus last two sedation hours.,"['University Hospital Surgical Intensive Care Unit and included consecutive, postoperative ICU patients fulfilling the inclusion criteria', 'Thirty patients were recruited (female/male: 10/20, age 64\u2009±\u200911, Simplified Acute Physiology Score II 30\u2009±\u200910', 'critically ill patients', 'critically ill patients receiving constant minimum alveolar concentration of']","['sevoflurane', 'isoflurane', 'uninterrupted inhalational sedation with isoflurane, sevoflurane, or desflurane', 'isoflurane, sevoflurane, or desflurane', 'isoflurane, sevoflurane, and desflurane', 'isoflurane and sevoflurane']","['RASS and EEG-derived N_Index', 'Sedation depth', 'electroencephalography (EEG)-derived Narcotrend-Index (burst-suppression N_Index 0-awake']","[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C1690590', 'cui_str': 'Surgical intensive care unit'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0022180', 'cui_str': 'Isoflurane'}, {'cui': 'C0412777', 'cui_str': 'Inhalational sedation'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}]","[{'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0429306', 'cui_str': 'Burst suppression'}, {'cui': 'C0234422', 'cui_str': 'Awake'}]",30.0,0.0409121,The t-test indicated in the isoflurane and sevoflurane groups a significant drop in RASS and EEG-derived N_Index in the first versus last two sedation hours.,"[{'ForeName': 'Adrian-Iustin', 'Initials': 'AI', 'LastName': 'Georgevici', 'Affiliation': 'St. Josef-Hospital, University Hospital of Ruhr-University of Bochum, Bochum, Germany. adrian-iustin.georgevici@rub.de.'}, {'ForeName': 'Theodoros', 'Initials': 'T', 'LastName': 'Kyprianou', 'Affiliation': 'Medical School, University of Nicosia, Nicosia, Cyprus.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Herzog-Niescery', 'Affiliation': 'St. Josef-Hospital, University Hospital of Ruhr-University of Bochum, Bochum, Germany.'}, {'ForeName': 'Livia', 'Initials': 'L', 'LastName': 'Procopiuc', 'Affiliation': ""Paediatric Intensive Care Unit - Evelina London Children's Healthcare, Guy's and St. Thomas, Westminster Bridge Road, London, UK.""}, {'ForeName': 'Sivakkanan', 'Initials': 'S', 'LastName': 'Loganathan', 'Affiliation': 'St. Josef-Hospital, University Hospital of Ruhr-University of Bochum, Bochum, Germany.'}, {'ForeName': 'Thomas Peter', 'Initials': 'TP', 'LastName': 'Weber', 'Affiliation': 'St. Josef-Hospital, University Hospital of Ruhr-University of Bochum, Bochum, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bellgardt', 'Affiliation': 'St. Josef-Hospital, University Hospital of Ruhr-University of Bochum, Bochum, Germany.'}]","Critical care (London, England)",['10.1186/s13054-021-03556-y'] 3570,33849611,"Impact of a shared decision-making mHealth tool on caregivers' team situational awareness, communication effectiveness, and performance during pediatric cardiopulmonary resuscitation: study protocol of a cluster randomized controlled trial.","BACKGROUND Effective team communication, coordination, and situational awareness (SA) by team members are critical components to deliver optimal cardiopulmonary resuscitation (CPR). Complexity of care during CPR, involvement of numerous providers, miscommunication, and other exogenous factors can all contribute to negatively influencing patient care, thus jeopardizing survival. We aim to investigate whether an mHealth supportive tool (the Interconnected and Focused Mobile Apps on patient Care Environment [InterFACE]) developed as a collaborative platform to support CPR providers in real-time and share patient-centered information would increase SA during pediatric CPR. METHODS We will conduct a prospective, cluster randomized controlled trial by groups of 6 participants in a tertiary pediatric emergency department (33,000 consultations/year) with pediatric physicians and nurses. We will compare the impact of the InterFACE tool with conventional communication methods on SA and effective team communication during a standardized pediatric in-hospital cardiac arrest and a polytrauma high-fidelity simulations. Forty-eight participants will be randomized (1:1) to consecutively perform two 20-min video-recorded scenarios using either the mHealth tool or conventional methods. The primary endpoint is the SA score, measured with the Situation Awareness Global Assessment Technique (SAGAT) instrument. Enrollment will start in late 2020 and data analysis in early 2021. We anticipate that the intervention will be completed by early 2021 and study results will be submitted in mid 2021 for publication. DISCUSSION This clinical trial will assess the impact of a collaborative mHealth tool on increasing situational awareness and effective team communication during in-hospital pediatric resuscitation. As research in this area is scarce, the results generated by this study may become of paramount importance in improving the care of children receiving in-hospital CPR, in the era of increasing communication technology. TRIAL REGISTRATION ClinicalTrials.gov NCT04464603 . Registered on 9 July 2020.",2021,This clinical trial will assess the impact of a collaborative mHealth tool on increasing situational awareness and effective team communication during in-hospital pediatric resuscitation.,"['patient Care Environment [InterFACE', 'hospital pediatric resuscitation', '6 participants in a tertiary pediatric emergency department (33,000 consultations/year) with pediatric physicians and nurses']","['shared decision-making mHealth tool', '20-min video-recorded scenarios using either the mHealth tool or conventional methods']","['SA score, measured with the Situation Awareness Global Assessment Technique (SAGAT) instrument']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0557735', 'cui_str': 'Caring environment'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}]",48.0,0.0814143,This clinical trial will assess the impact of a collaborative mHealth tool on increasing situational awareness and effective team communication during in-hospital pediatric resuscitation.,"[{'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Ehrler', 'Affiliation': 'Department of Diagnostic, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Sahyoun', 'Affiliation': ""Department of Pediatric Emergency Medicine, Children's Hospital, Geneva University Hospitals, 47 Avenue de la Roseraie, 1211, Geneva 14, Switzerland.""}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Manzano', 'Affiliation': ""Department of Pediatric Emergency Medicine, Children's Hospital, Geneva University Hospitals, 47 Avenue de la Roseraie, 1211, Geneva 14, Switzerland.""}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Sanchez', 'Affiliation': 'Division of Pediatric Surgery, University Center of Pediatric Surgery of Western Switzerland, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Gervaix', 'Affiliation': ""Department of Pediatric Emergency Medicine, Children's Hospital, Geneva University Hospitals, 47 Avenue de la Roseraie, 1211, Geneva 14, Switzerland.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lovis', 'Affiliation': 'Department of Radiology and Medical Informatics, Division of Medical Information Sciences, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Delphine S', 'Initials': 'DS', 'LastName': 'Courvoisier', 'Affiliation': 'Quality of Care Unit, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Lacroix', 'Affiliation': ""Department of Pediatric Emergency Medicine, Children's Hospital, Geneva University Hospitals, 47 Avenue de la Roseraie, 1211, Geneva 14, Switzerland.""}, {'ForeName': 'Johan N', 'Initials': 'JN', 'LastName': 'Siebert', 'Affiliation': ""Department of Pediatric Emergency Medicine, Children's Hospital, Geneva University Hospitals, 47 Avenue de la Roseraie, 1211, Geneva 14, Switzerland. Johan.Siebert@hcuge.ch.""}]",Trials,['10.1186/s13063-021-05170-3'] 3571,33849608,"Effect of prior treatments on selinexor, bortezomib, and dexamethasone in previously treated multiple myeloma.","Therapeutic regimens for previously treated multiple myeloma (MM) may not provide prolonged disease control and are often complicated by significant adverse events, including peripheral neuropathy. In patients with previously treated MM in the Phase 3 BOSTON study, once weekly selinexor, once weekly bortezomib, and 40 mg dexamethasone (XVd) demonstrated a significantly longer median progression-free survival (PFS), higher response rates, deeper responses, a trend to improved survival, and reduced incidence and severity of bortezomib-induced peripheral neuropathy when compared with standard twice weekly bortezomib and 80 mg dexamethasone (Vd). The pre-specified analyses described here evaluated the influence of the number of prior lines of therapy, prior treatment with lenalidomide, prior proteasome inhibitor (PI) therapy, prior immunomodulatory drug therapy, and prior autologous stem cell transplant (ASCT) on the efficacy and safety of XVd compared with Vd. In this 1:1 randomized study, enrolled patients were assigned to receive once weekly oral selinexor (100 mg) with once weekly subcutaneous bortezomib (1.3 mg/m 2 ) and 40 mg per week dexamethasone (XVd) versus standard twice weekly bortezomib and 80 mg per week dexamethasone (Vd). XVd significantly improved PFS, overall response rate, time-to-next-treatment, and showed reduced all grade and grade ≥ 2 peripheral neuropathy compared with Vd regardless of prior treatments, but the benefits of XVd over Vd were more pronounced in patients treated earlier in their disease course who had either received only one prior therapy, had never been treated with a PI, or had prior ASCT. Treatment with XVd improved outcomes as compared to Vd regardless of prior therapies as well as manageable and generally reversible adverse events. XVd was associated with clinical benefit and reduced peripheral neuropathy compared to standard Vd in previously treated MM. These results suggest that the once weekly XVd regimen may be optimally administered to patients earlier in their course of disease, as their first bortezomib-containing regimen, and in those relapsing after ASCT.Trial registration: ClinicalTrials.gov (NCT03110562). Registered 12 April 2017. https://clinicaltrials.gov/ct2/show/NCT03110562 .",2021,Treatment with XVd improved outcomes as compared to Vd regardless of prior therapies as well as manageable and generally reversible adverse events.,"['previously treated multiple myeloma', 'enrolled patients']","['dexamethasone', 'lenalidomide, prior proteasome inhibitor (PI) therapy, prior immunomodulatory drug therapy, and prior autologous stem cell transplant (ASCT', 'bortezomib', 'dexamethasone (XVd) versus standard twice weekly bortezomib and 80\xa0mg per week dexamethasone (Vd', 'oral selinexor', 'dexamethasone (XVd', 'selinexor, bortezomib, and dexamethasone', 'subcutaneous bortezomib']","['efficacy and safety of XVd', 'clinical benefit and reduced peripheral neuropathy', 'median progression-free survival (PFS), higher response rates, deeper responses, a trend to improved survival, and reduced incidence and severity of bortezomib-induced peripheral neuropathy', 'PFS, overall response rate, time-to-next-treatment']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1443643', 'cui_str': 'Proteasome inhibitor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3852671', 'cui_str': 'Selinexor'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0040833', 'cui_str': 'trends'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.0289994,Treatment with XVd improved outcomes as compared to Vd regardless of prior therapies as well as manageable and generally reversible adverse events.,"[{'ForeName': 'Maria V', 'Initials': 'MV', 'LastName': 'Mateos', 'Affiliation': 'Hospital Universitario de Salamanca, Salamanca, Spain. mvmateos@usal.es.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Gavriatopoulou', 'Affiliation': 'Alexandra Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Facon', 'Affiliation': 'CHU Lille Service Des Maladies du Sang, 59000, Lille, France.'}, {'ForeName': 'Holger W', 'Initials': 'HW', 'LastName': 'Auner', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Leleu', 'Affiliation': 'Department of Hematology, CHU La Miletrie and Inserm CIC 1402, Poitiers, France.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hájek', 'Affiliation': 'Department of Hematooncology, University Hospital Ostrava, Ostrava, Czech Republic.'}, {'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Sosana', 'Initials': 'S', 'LastName': 'Delimpasi', 'Affiliation': 'General Hospital Evangelismos, Athens, Greece.'}, {'ForeName': 'Maryana', 'Initials': 'M', 'LastName': 'Simonova', 'Affiliation': 'Institute of Blood Pathology and Transfusion Medicine of NAMS of Ukraine, Lviv, Ukraine.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Špička', 'Affiliation': 'Charles University and General Hospital, Prague, Czech Republic.'}, {'ForeName': 'Ludĕk', 'Initials': 'L', 'LastName': 'Pour', 'Affiliation': 'University Hospital Brno, Brno, Czech Republic.'}, {'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Kriachok', 'Affiliation': 'National Cancer Institute, Kiev, Ukraine.'}, {'ForeName': 'Halyna', 'Initials': 'H', 'LastName': 'Pylypenko', 'Affiliation': 'Cherkassy Regional Oncological Center, Cherkassy, Ukraine.'}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Doronin', 'Affiliation': 'City Clinical Hospital #40, Moscow, Russian Federation.'}, {'ForeName': 'Ganna', 'Initials': 'G', 'LastName': 'Usenko', 'Affiliation': 'City Clinical Hospital No. 4 of Dnipro City Council, Dnipro, Ukraine.'}, {'ForeName': 'Reuben', 'Initials': 'R', 'LastName': 'Benjamin', 'Affiliation': 'Kings College Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Tuphan K', 'Initials': 'TK', 'LastName': 'Dolai', 'Affiliation': 'Nil Ratan Sircar Medical College and Hospital, Kolkata, India.'}, {'ForeName': 'Dinesh K', 'Initials': 'DK', 'LastName': 'Sinha', 'Affiliation': 'State Cancer Institute, Indira Gandhi Institute of Medical Sciences, Patna, India.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Venner', 'Affiliation': 'Cross Cancer Institute, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Mamta', 'Initials': 'M', 'LastName': 'Garg', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Don A', 'Initials': 'DA', 'LastName': 'Stevens', 'Affiliation': 'Norton Cancer Institute, St. Matthews Campus, Louisville, KY, USA.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Quach', 'Affiliation': ""St Vincent's Hospital, University of Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Sundar', 'Initials': 'S', 'LastName': 'Jagannath', 'Affiliation': 'Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'Hotel-Dieu, University Hospital, Nantes, France.'}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Levy', 'Affiliation': 'Baylor University Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Ashraf Z', 'Initials': 'AZ', 'LastName': 'Badros', 'Affiliation': 'Greenebaum Comprehensive Cancer Center, University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'Larry D', 'Initials': 'LD', 'LastName': 'Anderson', 'Affiliation': 'Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Nizar J', 'Initials': 'NJ', 'LastName': 'Bahlis', 'Affiliation': 'Charbonneau Cancer Research Institute, University of Calgary, Calgary, AB, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'Seràgnoli Institute of Hematology, Bologna University School of Medicine, Bologna, Italy.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Chai', 'Affiliation': 'Karyopharm Therapeutics Inc, Newton, MA, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Jeha', 'Affiliation': 'Karyopharm Therapeutics Inc, Newton, MA, USA.'}, {'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Arazy', 'Affiliation': 'Karyopharm Therapeutics Inc, Newton, MA, USA.'}, {'ForeName': 'Jatin', 'Initials': 'J', 'LastName': 'Shah', 'Affiliation': 'Karyopharm Therapeutics Inc, Newton, MA, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Shacham', 'Affiliation': 'Karyopharm Therapeutics Inc, Newton, MA, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Kauffman', 'Affiliation': 'Karyopharm Therapeutics Inc, Newton, MA, USA.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Richardson', 'Affiliation': 'Dana Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Grosicki', 'Affiliation': 'Medical University of Silesia, Katowice, Poland.'}]",Journal of hematology & oncology,['10.1186/s13045-021-01071-9'] 3572,33849606,IOERT versus external beam electrons for boost radiotherapy in stage I/II breast cancer: 10-year results of a phase III randomized study.,"BACKGROUND Intraoperative radiotherapy with electrons (IOERT) boost could be not inferior to external beam radiotherapy (EBRT) boost in terms of local control and tissue tolerance. The aim of the study is to present the long-term follow-up results on local control, esthetic evaluation, and toxicity of a prospective study on early-stage breast cancer patients treated with breast-conserving surgery with an IOERT boost of 10 Gy (experimental group) versus 5 × 2 Gy EBRT boost (standard arm). Both arms received whole-breast irradiation (WBI) with 50 Gy (2 Gy single dose). METHODS A single-institution phase III randomized study to compare IOERT versus EBRT boost in early-stage breast cancer was conducted as a non-inferiority trial. Primary endpoints were the evaluation of in-breast true recurrences (IBTR) and out-field local recurrences (LR) as well as toxicity and cosmetic results. Secondary endpoints were overall survival (OS), disease-free survival (DFS), and patient's grade of satisfaction with cosmetic outcomes. RESULTS Between 1999 and 2004, 245 patients were randomized: 133 for IOERT and 112 for EBRT. The median follow-up was 12 years (range 10-16 years). The cumulative risk of IBTR at 5-10 years was 0.8% and 4.3% after IOERT, compared to 4.2% and 5.3% after EBRT boost (p = 0.709). The cumulative risk of out-field LR at 5-10 years was 4.7% and 7.9% for IOERT versus 5.2% and 10.3% for EBRT (p = 0.762). All of the IOERT arm recurrences were observed at > 100 months' follow-up, whereas the mean time to recurrence in the EBRT group was earlier (55.2 months) (p < 0.05). No late complications associated with IOERT were observed. The overall cosmetic results were scored as good or excellent in physician and patient evaluations for both IOERT and EBRT. There were significantly better scores for IOERT at all time points in physician and patient evaluations with the greatest difference at the end of EBRT (p = 0.006 objective and p = 0.0004 subjective) and most narrow difference at 12 months after the end of EBRT (p = 0.08 objective and p = 0.04 subjective analysis). CONCLUSION A 10-Gy IOERT boost during breast-conserving surgery provides high local control rates without significant morbidity. Although not significantly superior to external beam boosts, the median time to local recurrences after IOERT is prolonged by more than 4 years.",2021,"There were significantly better scores for IOERT at all time points in physician and patient evaluations with the greatest difference at the end of EBRT (p = 0.006 objective and p = 0.0004 subjective) and most narrow difference at 12 months after the end of EBRT (p = 0.08 objective and p = 0.04 subjective analysis). ","['245 patients were randomized: 133 for IOERT and 112 for EBRT', 'stage I/II breast cancer', 'early-stage breast cancer patients treated with', 'Between 1999 and 2004', 'early-stage breast cancer']","['IOERT versus external beam electrons', 'breast-conserving surgery with an IOERT boost of 10\u2009Gy (experimental group) versus 5\u2009×\u20092 Gy EBRT boost (standard arm', 'external beam radiotherapy (EBRT', 'Intraoperative radiotherapy with electrons (IOERT', 'IOERT versus EBRT', 'whole-breast irradiation (WBI) with 50 Gy (2 Gy single dose']","['cumulative risk of IBTR', 'mean time to recurrence', 'overall cosmetic results', 'median time to local recurrences', 'IOERT arm recurrences', 'local control, esthetic evaluation, and toxicity', 'evaluation of in-breast true recurrences (IBTR) and out-field local recurrences (LR) as well as toxicity and cosmetic results', ""overall survival (OS), disease-free survival (DFS), and patient's grade of satisfaction with cosmetic outcomes"", 'cumulative risk of out-field LR']","[{'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0338240', 'cui_str': 'Intraoperative radiation therapy'}, {'cui': 'C0013852', 'cui_str': 'Electron'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0338240', 'cui_str': 'Intraoperative radiation therapy'}, {'cui': 'C0013852', 'cui_str': 'Electron'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0013840', 'cui_str': 'Electron beam'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0205238', 'cui_str': 'True'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0338240', 'cui_str': 'Intraoperative radiation therapy'}, {'cui': 'C0013852', 'cui_str': 'Electron'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",245.0,0.0419014,"There were significantly better scores for IOERT at all time points in physician and patient evaluations with the greatest difference at the end of EBRT (p = 0.006 objective and p = 0.0004 subjective) and most narrow difference at 12 months after the end of EBRT (p = 0.08 objective and p = 0.04 subjective analysis). ","[{'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Ciabattoni', 'Affiliation': 'Department of Radiotherapy, San Filippo Neri Hospital, ASL Roma 1, Rome, Italy.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Gregucci', 'Affiliation': 'Department of Radiation Oncology, Miulli General Regional Hospital, Acquaviva delle Fonti, Bari, Italy. fabianagregucci@gmail.com.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Fastner', 'Affiliation': 'Department of Radiotherapy and Radio-Oncology, Paracelsus Medical University Hospital Salzburg, Landeskrankenhaus, Salzburg, Austria.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Cavuto', 'Affiliation': 'Infrastructure Research and Statistics, Clinical Trials and Statistics Unit, AUSL-IRCCS, Reggio Emilia, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Spera', 'Affiliation': 'Department of Radiotherapy, San Giovanni di Dio Hospital, ASP Agrigento, Agrigento, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Drago', 'Affiliation': 'Department of Breast and Reconstructive Surgery, Sando Pertini Hospital, Rome, Italy.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Ziegle', 'Affiliation': 'Department of Radiotherapy and Radio-Oncology, Paracelsus Medical University Hospital Salzburg, Landeskrankenhaus, Salzburg, Austria.'}, {'ForeName': 'Maria Alessandra', 'Initials': 'MA', 'LastName': 'Mirri', 'Affiliation': 'Department of Radiotherapy, San Filippo Neri Hospital, ASL Roma 1, Rome, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Consorti', 'Affiliation': 'Medical Physics Unit, San Filippo Neri Hospital, ASL Roma 1, Rome, Italy.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Sedlmayer', 'Affiliation': 'Department of Radiotherapy and Radio-Oncology, Paracelsus Medical University Hospital Salzburg, Landeskrankenhaus, Salzburg, Austria.'}]",Breast cancer research : BCR,['10.1186/s13058-021-01424-9'] 3573,33849584,"Randomized clinical trial of the effect of the onset time of skin-to-skin contact at birth, immediate compared to early, on the duration of breastfeeding in full term newborns.","BACKGROUND Skin-to-skin contact (SSC) compared to separation at birth has a positive effect on breastfeeding. However, separation at birth is common with negative impact on breastfeeding. The aim was to determine the effect of immediate SSC compared to early SSC on the duration of exclusive breastfeeding. METHODS A randomized multicentre parallel clinical trial was conducted in two hospitals in Cundinamarca (Colombia) between November 2018 and January 2020. Low-risk full term newborns at birth were included. Neonates were assigned to immediate (in the first minute after birth) or early onset (start exactly at 60 min of life) skin to skin contact. Monthly follow-up was performed until 6 months of age. The primary outcome was the percentage of exclusively breastfed infants at 6 months (time in months with human milk as the only source of food). Secondary outcomes were the percentage of infants with exclusive breastfeeding at 3 months, duration in months of exclusive breastfeeding, neonate's breastfeeding ability, percentage of weight change between birth and the first week of life and hospitalization in the neonatal unit in the first week. A bivariate analysis was performed to determine the variables associated with exclusive breastfeeding at 6 months. A survival analysis was performed to evaluate the effect of the onset of SSC on exclusive breastfeeding duration. RESULTS A total of 297 newborns were included: 49.8% (n = 148) in the immediate SSC group, and 50.2% (n = 149) in the early SSC group. The mean duration of exclusive breastfeeding in both groups was 5 months. There were no differences between the groups in the percentage of exclusive breastfeeding at 6 months (relative risk [RR] 1.06, 95% CI 0.72, 1.58) or in the duration of exclusive breastfeeding (hazard ratio [HR] 0.98, 95% CI 0.74, 1.28). CONCLUSIONS The percentage of infants and the duration of exclusive breastfeeding in the first 6 months of age were the same between the two groups of SSC interventions. Given the current barriers to its implementation, the results of this study could positively impact the use of SSC at birth and standardize the intervention and improve breastfeeding indicators. TRIAL REGISTRATION ClinicalTrials.gov NCT02687685 .",2021,The percentage of infants and the duration of exclusive breastfeeding in the first 6 months of age were the same between the two groups of SSC interventions.,"['Low-risk full term newborns at birth', 'full term newborns', '297 newborns were included: 49.8% (n\u2009=\u2009148) in the immediate SSC group, and 50.2% (n\u2009=\u2009149) in the early SSC group', 'two hospitals in Cundinamarca (Colombia) between November 2018 and January 2020']","['immediate SSC', 'Skin-to-skin contact (SSC', 'skin-to-skin contact']","['mean duration of exclusive breastfeeding', 'percentage of exclusively breastfed infants at 6 months (time in months with human milk as the only source of food', 'percentage of exclusive breastfeeding', ""percentage of infants with exclusive breastfeeding at 3 months, duration in months of exclusive breastfeeding, neonate's breastfeeding ability, percentage of weight change between birth and the first week of life and hospitalization in the neonatal unit in the first week"", 'duration of exclusive breastfeeding']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026140', 'cui_str': 'Breast milk'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]",297.0,0.0959546,The percentage of infants and the duration of exclusive breastfeeding in the first 6 months of age were the same between the two groups of SSC interventions.,"[{'ForeName': 'Sergio I', 'Initials': 'SI', 'LastName': 'Agudelo', 'Affiliation': 'Facultad de Medicina, Universidad de La Sabana, Chía, Colombia. sergioagpe@unisabana.edu.co.'}, {'ForeName': 'Oscar A', 'Initials': 'OA', 'LastName': 'Gamboa', 'Affiliation': 'Facultad de Medicina, Universidad de La Sabana, Chía, Colombia.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Acuña', 'Affiliation': 'Departamento de Pediatría, Hospital Universitario de La Samaritana - Unidad Funcional de Zipaquirá, Zipaquirá, Colombia.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Aguirre', 'Affiliation': 'Facultad de Medicina, Universidad de La Sabana, Chía, Colombia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bastidas', 'Affiliation': 'Facultad de Medicina, Universidad de La Sabana, Chía, Colombia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Guijarro', 'Affiliation': 'Facultad de Medicina, Universidad de La Sabana, Chía, Colombia.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Jaller', 'Affiliation': 'Facultad de Medicina, Universidad de La Sabana, Chía, Colombia.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Valderrama', 'Affiliation': 'Facultad de Medicina, Universidad de La Sabana, Chía, Colombia.'}, {'ForeName': 'María Lucia', 'Initials': 'ML', 'LastName': 'Padrón', 'Affiliation': 'Facultad de Medicina, Universidad de La Sabana, Chía, Colombia.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Gualdrón', 'Affiliation': 'Facultad de Medicina, Universidad de La Sabana, Chía, Colombia.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Obando', 'Affiliation': 'Facultad de Medicina, Universidad de La Sabana, Chía, Colombia.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Rodríguez', 'Affiliation': 'Facultad de Medicina, Universidad de La Sabana, Chía, Colombia.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Buitrago', 'Affiliation': 'Facultad de Medicina, Universidad de La Sabana, Chía, Colombia.'}]",International breastfeeding journal,['10.1186/s13006-021-00379-z'] 3574,33849582,"Feasibility, acceptability, and potential efficacy of an innovative postnatal home-based breastfeeding peer support programme in Hong Kong: a feasibility and pilot randomised controlled trial.","BACKGROUND As suggested by the World Health Organization, breastfeeding peer support is being introduced worldwide to support women's breastfeeding needs. Evidence has shown that when such support is offered to women, the duration and exclusivity of breastfeeding is increased. We developed an innovative home-based intervention to sustain exclusive breastfeeding in Hong Kong. However, potential barriers must be addressed before a full randomised controlled trial (RCT) is conducted. The aim of this study was to determine the feasibility of a breastfeeding support programme with home-based visits from peer supporters over a six month period among postpartum Chinese women in Hong Kong. METHODS We conducted a feasibility and pilot randomised controlled trial. Twenty primiparous women intending to breastfeed their healthy term singleton infant were recruited from a hospital in Kowloon, Hong Kong between February and March 2019. Participants were randomly allocated to the intervention or control group. Participants in the intervention group received five home-based visits with a peer supporter over a six month period, as well as standard care, whereas participants in the control group received standard care only. We assessed feasibility, compliance, and acceptability of the breastfeeding peer support programme. Other outcomes assessed were breastfeeding self-efficacy, duration, and exclusivity. RESULTS It was feasible to recruit and train existing peer supporters, and peer supporters were able to deliver the intervention, which was acceptable to women, but rates of stopping the intervention and loss to follow-up were high. There was higher retention seen within the first month. Women interviewed at the end of the study reported that the intervention was positive. The cessation risk of any, and exclusive breastfeeding were not statistically different between the intervention and control groups. CONCLUSIONS This study provided valuable information on feasibility of the trial design and intervention. Modifications to the intervention, such as targeting women with lower breastfeeding self-efficacy, or combining home visits with technology and telephone follow-up may be more appropriate in a larger trial. Implementing the programme early during the antenatal phase and tailoring peer support to most appropriately sustain exclusive breastfeeding and other feeding modes should be incorporated in a future home-based peer support arm. TRIAL REGISTRATION NCT03705494 on 15 Oct 2018.",2021,"It was feasible to recruit and train existing peer supporters, and peer supporters were able to deliver the intervention, which was acceptable to women, but rates of stopping the intervention and loss to follow-up were high.","['postpartum Chinese women in Hong Kong', 'Twenty primiparous women intending to breastfeed their healthy term singleton infant were recruited from a hospital in Kowloon, Hong Kong between February and March 2019']","['five home-based visits with a peer supporter', 'innovative home-based intervention to sustain exclusive breastfeeding in Hong Kong', 'control group received standard care only', 'innovative postnatal home-based breastfeeding peer support programme', 'breastfeeding support programme with home-based visits from peer supporters']","['cessation risk of any, and exclusive breastfeeding', 'feasibility, compliance, and acceptability', 'breastfeeding self-efficacy, duration, and exclusivity', 'Feasibility, acceptability, and potential efficacy']","[{'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1171181', 'cui_str': 'Breastfeeding support'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",20.0,0.0264735,"It was feasible to recruit and train existing peer supporters, and peer supporters were able to deliver the intervention, which was acceptable to women, but rates of stopping the intervention and loss to follow-up were high.","[{'ForeName': 'Kris Yuet-Wan', 'Initials': 'KY', 'LastName': 'Lok', 'Affiliation': 'School of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong Kong, 4/F, William MW Mong Block, 21 Sassoon Road, Pokfulam, Hong Kong. krislok@hku.hk.'}, {'ForeName': 'Charlotte L Y', 'Initials': 'CLY', 'LastName': 'Chow', 'Affiliation': 'School of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong Kong, 4/F, William MW Mong Block, 21 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Jeffery Sheung Yu', 'Initials': 'JSY', 'LastName': 'Shing', 'Affiliation': 'School of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong Kong, 4/F, William MW Mong Block, 21 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Smith', 'Affiliation': 'School of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong Kong, 4/F, William MW Mong Block, 21 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Christine Chi Oi', 'Initials': 'CCO', 'LastName': 'Lam', 'Affiliation': 'Department of Obstetrics & Gynaecology, Queen Elizabeth Hospital, Kowloon, Hong Kong.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Bick', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Warwick, Gibbet Hill, CV4 7AL, UK.'}, {'ForeName': 'Yan-Shing', 'Initials': 'YS', 'LastName': 'Chang', 'Affiliation': ""Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care, King's College London, James Clerk Maxwell Building, 57 Waterloo Road, London, SE1 8WA, UK.""}]",International breastfeeding journal,['10.1186/s13006-021-00381-5'] 3575,33849517,Developing and testing of an interactive internet-based intervention to reduce sexual harm of sexualised drug use ('chemsex') among men who have sex with men in Hong Kong: a study protocol for a randomised controlled trial.,"BACKGROUND Sexualised drug use, known as 'chemsex' or 'chemfun,' is the practice of intentionally using illicit drugs before or during sexual activates to enhance sexual arousal and pleasure. International and local data have both suggested that chemsex is common among men who have sex with men (MSM). Chemsex is generally seen with the engagement of risky sexual activities and therefore poses a threat regarding the potentially increased spread of human immunodeficiency virus and other sexually transmitted infections. However, little work has been done on the primary prevention of chemsex among MSM. Therefore, the aim of this study is to develop and evaluate an interactive internet-based intervention in reducing the sexual harms of chemsex among MSM in Hong Kong, METHODS: A two-armed, randomised, parallel-group trial with a three-month follow-up period will be conducted. 250 MSM aged 18 years or the above will be recruited through local non-governmental organisations, social media and by snowballing in Hong Kong. Participants will be randomly allocated into either the intervention (n = 125) or control group (n = 125). The interactive internet-based intervention will be developed based on the theory of planned behaviours. Participants in the control group will receive a web-based intervention without any sexual health information and without any interactive components. The primary outcomes will be self-efficacy in refusing risky sexual behaviours and chemsex, as measured by the Drug Avoidance Self-Efficacy Scale, the Self-Efficacy for Sexual Safety and the Condom Self-Efficacy Scale. Subjects in both groups will be evaluated at baseline and 3 months after baseline. DISCUSSION To the best of our knowledge, this will be the first interactive internet-based intervention to specifically target chemsex among MSM. This project can help in the development and testing of culturally relevant health promotion programmes that reduce chemsex among MSM. Using an online delivery mode, the intervention is capable of reaching a large population of targets at a relatively low cost and thus has the potential to reduce the public health burden of chemsex and other risky sexual behaviours among MSM in a cost-effective manner. TRIAL REGISTRATION International standard randomized controlled trial number (ISRCTN) registry: ISRCTN20134522 registered on 17 March 2021.",2021,"The primary outcomes will be self-efficacy in refusing risky sexual behaviours and chemsex, as measured by the Drug Avoidance Self-Efficacy Scale, the Self-Efficacy for Sexual Safety and the Condom Self-Efficacy Scale.","['250 MSM aged 18\u2009years or the above will be recruited through local non-governmental organisations, social media and by snowballing in Hong Kong', 'men who have sex with men in Hong Kong', 'men who have sex with men (MSM']","['web-based intervention without any sexual health information and without any interactive components', ""interactive internet-based intervention to reduce sexual harm of sexualised drug use ('chemsex"", 'interactive internet-based intervention']","['self-efficacy in refusing risky sexual behaviours and chemsex, as measured by the Drug Avoidance Self-Efficacy Scale, the Self-Efficacy for Sexual Safety and the Condom Self-Efficacy Scale']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0017095', 'cui_str': 'Trash'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]",250.0,0.116261,"The primary outcomes will be self-efficacy in refusing risky sexual behaviours and chemsex, as measured by the Drug Avoidance Self-Efficacy Scale, the Self-Efficacy for Sexual Safety and the Condom Self-Efficacy Scale.","[{'ForeName': 'Edmond P H', 'Initials': 'EPH', 'LastName': 'Choi', 'Affiliation': 'School of Nursing, University of Hong Kong, 4/F, William M.W. Mong Block 21 Sassoon Road, Pokfulam, Hong Kong. h0714919@connect.hku.hk.'}, {'ForeName': 'Pui Hing', 'Initials': 'PH', 'LastName': 'Chau', 'Affiliation': 'School of Nursing, University of Hong Kong, 4/F, William M.W. Mong Block 21 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'William C W', 'Initials': 'WCW', 'LastName': 'Wong', 'Affiliation': 'Department of Family Medicine and Primary Care, University of Hong Kong, Ap Lei Chau, Hong Kong.'}, {'ForeName': 'Jojo Y Y', 'Initials': 'JYY', 'LastName': 'Kowk', 'Affiliation': 'School of Nursing, University of Hong Kong, 4/F, William M.W. Mong Block 21 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Kitty W Y', 'Initials': 'KWY', 'LastName': 'Choi', 'Affiliation': 'Sticky Rice Love, Hong Kong, Hong Kong.'}, {'ForeName': 'Eric P F', 'Initials': 'EPF', 'LastName': 'Chow', 'Affiliation': 'Melbourne Sexual Health Centre, Alfred Health, Melbourne, Victoria, Australia.'}]",BMC public health,['10.1186/s12889-021-10742-8'] 3576,33849510,Applying visual mapping techniques to promote learning in community-based medical education activities.,"BACKGROUND Teaching and learning Community-Based Medical Education (CBME) requires the active engagement of students in various activities to cover planned curricular content. CBME being multifaceted involves careful application and formation of links when attending to community health problems and public health issues. Students often depend on factual recall rather than 'engaging in', to counteract the broad and comprehensive nature of CBME. This study was conducted to assess the effectiveness of Visual mapping techniques as a learning tool in a CBME program for the subject Community Medicine and thereby assist medical undergraduate students in overcoming identified learning challenges. METHODOLOGY An interventional study was conducted where medical undergraduates were randomly assigned to two different groups (each group = 30). After sensitization, a broad theme was taught to both the groups as a part of community-based teaching (CBT), each week for a month. The students in the intervention group were given the assignment to draw visual maps using the mind mapping & concept mapping techniques, after each CBT session, while the control group had Question-Answer session with built-in discussion (Conventional method) by an equally qualified, experienced faculty with no mapping assignments. A surprise written examination was conducted on the topics taught, and scores of both the groups were compared. Feedback was obtained from the intervention group. RESULTS Mean score of the examination by the intervention group (29.85 ± 3.22) was significantly higher than and that of the control group (23.06 ± 4.09) (t = 7.14 and p < 0.05). The students shared that the assignment of drawing mind and concept maps for topics taught helped in attempting questions of the written examination by facilitating easy recall of the information learned. It aided to frame the answers to descriptive questions in a structured way with the use of keywords. However, identifying the concepts and establishing relationship between them was slightly challenging. CONCLUSION 'Visual mapping' in the form of Mind and Concept mapping was found to be an effective learning tool for multifaceted CBME especially in promoting meaningful learning and facilitating rational thinking by the medical undergraduates.",2021,Mean score of the examination by the intervention group (29.85 ± 3.22) was significantly higher than and that of the control group (23.06 ± 4.09) (t = 7.14 and p < 0.05).,"['medical undergraduates', 'medical undergraduate students']","['CBME', 'Teaching and learning Community-Based Medical Education (CBME', 'control group had Question-Answer session with built-in discussion (Conventional method) by an equally qualified, experienced faculty with no mapping assignments', 'Visual mapping techniques']",['Mean score of the examination'],"[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013631', 'cui_str': 'Medical Education'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0106392,Mean score of the examination by the intervention group (29.85 ± 3.22) was significantly higher than and that of the control group (23.06 ± 4.09) (t = 7.14 and p < 0.05).,"[{'ForeName': 'Sonali G', 'Initials': 'SG', 'LastName': 'Choudhari', 'Affiliation': 'Department of Community Medicine, Jawaharlal Nehru Medical College, Wardha, Maharashtra, India. sonalic27@yahoo.com.'}, {'ForeName': 'Abhay M', 'Initials': 'AM', 'LastName': 'Gaidhane', 'Affiliation': 'Department of Community Medicine, Jawaharlal Nehru Medical College, Wardha, Maharashtra, India.'}, {'ForeName': 'Priti', 'Initials': 'P', 'LastName': 'Desai', 'Affiliation': 'School of Health Professions Education & Research, Datta Meghe Institute of Medical Sciences, Wardha, Maharashtra, India.'}, {'ForeName': 'Tripti', 'Initials': 'T', 'LastName': 'Srivastava', 'Affiliation': 'Faculty Development Committee, Association for Medical Education in Europe (AMEE), Maharashtra, Wardha, India.'}, {'ForeName': 'Vedprakash', 'Initials': 'V', 'LastName': 'Mishra', 'Affiliation': 'Pro-Chancellor, Datta Meghe Institute of Medical Sciences, Maharashtra, Wardha, India.'}, {'ForeName': 'Syed Quazi', 'Initials': 'SQ', 'LastName': 'Zahiruddin', 'Affiliation': 'Department of Community Medicine, Jawaharlal Nehru Medical College, Wardha, Maharashtra, India.'}]",BMC medical education,['10.1186/s12909-021-02646-3'] 3577,33849503,Evaluating the influence of music at different sound pressure levels on medical students' performance of standardized laparoscopic box training exercises.,"BACKGROUND The influence of music on the performance of surgical procedures such as laparoscopy is controversial and methodologically difficult to quantify. Here, outcome measurements using laparoscopic box training tools under standardized conditions might offer a feasible approach. To date, the effect of music exposure at different sound pressure levels (SPL) on outcome has not been evaluated systematically for laparoscopic novices. METHODS Between May 2017 and October 2018, n = 87 students (49 males, 38 females) from Heidelberg University Medical School performed three different laparoscopy exercises using the ""Luebecker Toolbox"" that were repeated twice under standardized conditions. Time was recorded for each run. All students were randomly assigned to four groups exposed to the same music compilation but at different SPLs (50-80 dB), an acoustically shielded (earplug) group, or a control group (no intervention). RESULTS Best absolute performance was shown under exposure to 70 dB in all three exercises (a, b, c) with mean performance time of 121, 142, and 115 s (p < 0.05 for a and c). For the control group mean performance times were 157, 144, and 150 s, respectively. In the earplug group, no significant difference in performance was found compared to the control group (p > 0.05) except for exercise (a) (p = 0.011). CONCLUSION Music exposure seems to have beneficial effects on training performance. In comparison to the control group, significantly better results were reached at 70 dB SPL, while exposure to lower (50 or 60 dB) or higher (80 dB) SPL as well as under acoustic shielding did not influence performance.",2021,"In the earplug group, no significant difference in performance was found compared to the control group (p > 0.05) except for exercise (a) (p = 0.011). ","['Between May 2017 and October 2018, n\xa0', ""medical students' performance of standardized laparoscopic box training exercises"", '87 students (49 males, 38 females) from Heidelberg University Medical School performed three different']","['laparoscopy exercises', 'same music compilation but at different SPLs (50-80\u2009dB), an acoustically shielded (earplug) group, or a control group (no intervention']",['performance'],"[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036378', 'cui_str': 'Medical School'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0212465,"In the earplug group, no significant difference in performance was found compared to the control group (p > 0.05) except for exercise (a) (p = 0.011). ","[{'ForeName': 'Lisa Katharina', 'Initials': 'LK', 'LastName': 'Nees', 'Affiliation': 'Department of Gynecology and Obstetrics, Heidelberg University Hospital, Im Neuenheimer Feld 440, D-69120, Heidelberg, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Grozinger', 'Affiliation': 'Department of Gynecology and Obstetrics, Heidelberg University Hospital, Im Neuenheimer Feld 440, D-69120, Heidelberg, Germany.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Orthmann', 'Affiliation': 'Asklepios Klinik Hamburg-Altona, Department of Gynecology and Obstetric, Hamburg, Germany.'}, {'ForeName': 'Thomas Maximilian', 'Initials': 'TM', 'LastName': 'Deutsch', 'Affiliation': 'Department of Gynecology and Obstetrics, Heidelberg University Hospital, Im Neuenheimer Feld 440, D-69120, Heidelberg, Germany.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Hennigs', 'Affiliation': 'Department of Gynecology and Obstetrics, Heidelberg University Hospital, Im Neuenheimer Feld 440, D-69120, Heidelberg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Domschke', 'Affiliation': 'Department of Gynecology and Obstetrics, Heidelberg University Hospital, Im Neuenheimer Feld 440, D-69120, Heidelberg, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Wallwiener', 'Affiliation': 'Department of Gynecology and Obstetrics, Heidelberg University Hospital, Im Neuenheimer Feld 440, D-69120, Heidelberg, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Rom', 'Affiliation': 'Klinikum Frankfurt-Hoechst, Department of Gynecology and Obstetrics, Frankfurt, Germany.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Riedel', 'Affiliation': 'Department of Gynecology and Obstetrics, Heidelberg University Hospital, Im Neuenheimer Feld 440, D-69120, Heidelberg, Germany. fabian.riedel@med.uni-heidelberg.de.'}]",BMC medical education,['10.1186/s12909-021-02627-6'] 3578,33849494,The effect of oat bran consumption on gestational diabetes: a randomized controlled clinical trial.,"BACKGROUND Gestational diabetes is the most common medical complication in pregnancy, and it has many side effects for the mother and the fetus. The aim of this study was to evaluate the effect of oat bran consumption on gestational diabetes. METHODS This study is a randomized clinical trial that was performed on 112 women with gestational diabetes treated with diet. Participants were randomly divided into two groups of 56. Participants in both groups were given a diet for gestational diabetes. In addition to the diet, the intervention group received 30 g of oat bran daily for 4 weeks at lunch and dinner. Tests of fasting blood glucose and two-hour postprandial (2hpp) glucose were taken from both groups: before the intervention, and 2 and 4 weeks after the start of the intervention. Data analysis was performed using SPSS statistical software (version 22) using independent t-test, as well as Chi-square and Mann-Whitney tests. P values less than 0.05 were considered statistically significant. RESULTS There was no statistically significant difference between the two groups in terms of mean blood glucose before the intervention, while 2 and 4 weeks after the intervention, mean fasting blood glucose and two-hour postprandial (2hpp) glucose decreased significantly in the intervention group compared with the control group (P < 0.001). CONCLUSION Based on the results of this study, the addition of oat bran to the standard diet for pregnant women with gestational diabetes reduced fasting blood glucose and two-hour postprandial (2hpp) glucose. More detailed studies with higher sample sizes are recommended to prove the effectiveness of this valuable dietary supplement. TRIAL REGISTRATION IRCT registration number: IRCT20191220045828N1 . Registration date: 2020-04-18. Registered while recruiting.",2021,"There was no statistically significant difference between the two groups in terms of mean blood glucose before the intervention, while 2 and 4 weeks after the intervention, mean fasting blood glucose and two-hour postprandial (2hpp) glucose decreased significantly in the intervention group compared with the control group (P < 0.001). ","['pregnant women with gestational diabetes', 'IRCT registration number', '112 women with gestational diabetes treated with diet', 'gestational diabetes']","['oat bran consumption', 'oat bran']","['fasting blood glucose and two-hour postprandial (2hpp) glucose', 'gestational diabetes', 'mean fasting blood glucose and two-hour postprandial (2hpp) glucose', 'mean blood glucose']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0795649', 'cui_str': 'OAT BRAN'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}]",112.0,0.0315299,"There was no statistically significant difference between the two groups in terms of mean blood glucose before the intervention, while 2 and 4 weeks after the intervention, mean fasting blood glucose and two-hour postprandial (2hpp) glucose decreased significantly in the intervention group compared with the control group (P < 0.001). ","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Barati', 'Affiliation': 'School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Iravani', 'Affiliation': 'Reproductive Health Promotion Research Center, Midwifery Department, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. minairavani2004@yahoo.com.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Karandish', 'Affiliation': 'Department of Nutritional Sciences, School of Paramedical Sciences, Nutrition and Metabolic Disease Research Center, Ahvaz Jundishapur University of Medical sciences, Ahvaz, Iran.'}, {'ForeName': 'Mohammad Hosein', 'Initials': 'MH', 'LastName': 'Haghighizadeh', 'Affiliation': 'Biostatistics Department, School of public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Masihi', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Fertility Infertility and Perinatology Research Center, Imam Khomeini Hospital, Ahvaz, Iran.'}]",BMC endocrine disorders,['10.1186/s12902-021-00731-8'] 3579,33849465,"Correction to: Evaluation of FindMyApps: protocol for a randomized controlled trial of the effectiveness and cost-effectiveness of a tablet-based intervention to improve self-management and social participation of community-dwelling people with mild dementia, compared to usual tablet use.",,2021,,['community-dwelling people with mild dementia'],['tablet-based intervention'],['effectiveness and cost-effectiveness'],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3494623', 'cui_str': 'Mild dementia'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0294248,,"[{'ForeName': 'David Peter', 'Initials': 'DP', 'LastName': 'Neal', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Centers, location VUmc, Amsterdam, Netherlands.'}, {'ForeName': 'Yvonne J F', 'Initials': 'YJF', 'LastName': 'Kerkhof', 'Affiliation': 'Saxion University of Applied Sciences, Deventer, Netherlands.'}, {'ForeName': 'Teake P', 'Initials': 'TP', 'LastName': 'Ettema', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Centers, location VUmc, Amsterdam, Netherlands.'}, {'ForeName': 'Majon', 'Initials': 'M', 'LastName': 'Muller', 'Affiliation': 'Department of Internal Medicine, Amsterdam University Medical Centers, Amsterdam, Netherlands.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Bosmans', 'Affiliation': 'Department of Health Sciences, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Finnema', 'Affiliation': 'University Medical Centre Groningen, Groningen, Netherlands.'}, {'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Graff', 'Affiliation': 'Radboud University Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Dijkstra', 'Affiliation': 'Saxion University of Applied Sciences, Deventer, Netherlands.'}, {'ForeName': 'Max L', 'Initials': 'ML', 'LastName': 'Stek', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Centers, location VUmc, Amsterdam, Netherlands.'}, {'ForeName': 'Rose-Marie', 'Initials': 'RM', 'LastName': 'Dröes', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Centers, location VUmc, Amsterdam, Netherlands. rm.droes@amsterdamumc.nl.'}]",BMC geriatrics,['10.1186/s12877-021-02168-z'] 3580,33849417,"Psychological Continuum of Elderly Patients Suffering from Arterial Hypertension with Metabolic Syndrome, Against the Background of Chronotherapy with a Fixed Combination of Amlodipine, Lisinopril and Rosuvastatin.","Aim        To study the psychological continuum in elderly patients with arterial hypertension associated with metabolic syndrome during the chronotherapy with a fixed combination (FC) of amlodipine, lisinopril, and rosuvastatin.Material and methods        In the inpatient conditions, 63 patients aged 60-74 years with arterial hypertension associated with metabolic syndrome were treated with chronotherapy with a FC of amlodipine, lisinopril, and rosuvastatin (5 / 10 / 10 mg/day in the evening). These patients composed the main group. The control group (58 patients aged 60-74 years with arterial hypertension associated with metabolic syndrome) was treated with the FC of amlodipine, lisinopril, and rosuvastatin at the same dose of 5 / 10 / 10 mg/day in the morning.Results   At one year, the disorders of psychological continuum were significantly decreased with the chronotherapy (evening dosing) with the antihypertensive FC of amlodipine, lisinopril, and rosuvastatin compared to the traditional treatment (morning dosing) at the same dose of 5 / 10 / 10 mg/day in both groups. With the chronotherapeutic approach, the dynamic of cognitive disorders in patients aged 60-74 years with arterial hypertension associated with metabolic syndrome was characterized by a significant increase in the Mini-Mental-State-Examination scale score from 17.8±0.3 at baseline to 23.5±0.4 with the evening dosing (р<0.001) vs. the increase from 16.9±0.3 to 20.4±0.4 (р<0.001) with the morning dosing. The situational anxiety score decreased from 40.0±2.2 to 30.6±1.8 (р<0.05) and from 40.8±2.5 to 33.5±1.9  (р<0.05), and the trait anxiety score decreased from 48.8±2.0 to 26.4±1.9 (р<0.001) and from 44.9±1.9 to 30.7±1.7  (р<0.01) with the evening and morning dosing, respectively. Depressive disorders slightly decreased with the chronotherapy by 14.1 % vs. 7.7 % with the traditional regimen; nevertheless, they were consistent with depressive spectrum disorders in both groups.Conclusion            The study results showed a higher effectiveness of the chronotherapeutic treatment compared to the traditional treatment with FC of amlodipine, lisinopril, and rosuvastatin in arterial hypertension with metabolic syndrome.",2021,"The study results showed a higher effectiveness of the chronotherapeutic treatment compared to the traditional treatment with FC of amlodipine, lisinopril, and rosuvastatin in arterial hypertension with metabolic syndrome.","['elderly patients with arterial hypertension associated with metabolic syndrome during the chronotherapy with a fixed combination (FC) of', 'arterial hypertension with metabolic syndrome', '63 patients aged 60-74 years with arterial hypertension associated with metabolic syndrome', '58 patients aged 60-74 years with arterial hypertension associated with metabolic syndrome', 'patients aged 60-74 years with arterial hypertension associated with metabolic syndrome', 'Elderly Patients Suffering from Arterial Hypertension with Metabolic Syndrome, Against the of Chronotherapy with a Fixed Combination of']","['chronotherapy with a FC of amlodipine, lisinopril, and rosuvastatin', 'amlodipine, lisinopril, and rosuvastatin', 'Amlodipine, Lisinopril and Rosuvastatin']","['situational anxiety score', 'Mini-Mental-State-Examination scale score', 'disorders of psychological continuum', 'depressive spectrum disorders', 'trait anxiety score', 'Depressive disorders']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0376626', 'cui_str': 'Chronotherapy'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0376626', 'cui_str': 'Chronotherapy'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0065374', 'cui_str': 'Lisinopril'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}]","[{'cui': 'C0262377', 'cui_str': 'Situational anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}]",63.0,0.0261974,"The study results showed a higher effectiveness of the chronotherapeutic treatment compared to the traditional treatment with FC of amlodipine, lisinopril, and rosuvastatin in arterial hypertension with metabolic syndrome.","[{'ForeName': 'N M', 'Initials': 'NM', 'LastName': 'Agarkov', 'Affiliation': 'South-Western State University (SWSU), Kursk; Belgorod State National Research University, Belgorod.'}, {'ForeName': 'O I', 'Initials': 'OI', 'LastName': 'Okhotnikov', 'Affiliation': 'Kursk State Medical University, Kursk.'}, {'ForeName': 'S I', 'Initials': 'SI', 'LastName': 'Korneeva', 'Affiliation': 'Kursk State Medical University, Kursk.'}, {'ForeName': 'E O', 'Initials': 'EO', 'LastName': 'Moskaleva', 'Affiliation': 'Belgorod State National Research University, Belgorod.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Moskalev', 'Affiliation': 'Belgorod State National Research University, Belgorod.'}, {'ForeName': 'V I', 'Initials': 'VI', 'LastName': 'Kolomiets', 'Affiliation': 'Kursk State Medical University, Kursk.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Markelova', 'Affiliation': 'Kursk State Medical University, Kursk.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Markelova', 'Affiliation': 'Information and Methodological Center for the Examination, Accounting and Analysis of Medical Products, Kursk.'}]",Kardiologiia,['10.18087/cardio.2021.3.n1509'] 3581,33849415,Comparison of Different Intensity Modes of Neuromuscular Electrical Stimulation in the Rehabilitation of Elderly Patients with Decompensated Chronic Heart Failure.,"Aim        To compare effects of neuromuscular electrostimulation (NMES) with various intensity of induced muscle contractions on its tolerance and effect on physical work ability in elderly patients admitted for chronic heart failure (CHF).Material and methods        The study included 22 patients older than 60 years admitted for decompensated CHF. NMES was performed from the 2nd or 3d day of stay in the hospital to the discharge from the hospital. Patients choose the stimulation regimen themselves based on the result of the first session: the high intensity to achieve maximum tolerable muscle contractions (group 1) or the lower intensity to achieve visible/ palpable muscle contractions (group 2). Prior to the onset and after the completion of the training, the 6-min walk test (6MWT) was performed and the general condition of the patient was assessed with a visual analogue scale (VAS).Results   More patients, mostly women, chose the less intensive NMES (14 vs. 8). The groups did not differ in age, comorbidity, and functional condition. Both groups achieved considerable increases in the 6MWT distance (7.3 [5.6; 176] and 9.8 [7.0; 9.9] %, respectively, p>0.05) and VAS scores without a significant difference between the groups. Among the patients who were compliant with continuing NMES after the discharge from the hospital, 69% were patients of the group of the less intensive stimulation.Conclusion            The less intensive NMES (with achieving visible muscle contractions) was characterized by better tolerance and better compliance in elderly patients with decompensated CHF compared to the more intensive NMES (with achieving maximum contractions), but the less intensive NMES was not inferior to the more intensive NMES in effectiveness.",2021,"The less intensive NMES (with achieving visible muscle contractions) was characterized by better tolerance and better compliance in elderly patients with decompensated CHF compared to the more intensive NMES (with achieving maximum contractions), but the less intensive NMES was not inferior to the more intensive NMES in effectiveness.","['elderly patients with decompensated CHF', '22 patients older than 60 years admitted for decompensated CHF', 'elderly patients admitted for chronic heart failure (CHF).Material and methods', 'Elderly Patients with Decompensated Chronic Heart Failure']","['Neuromuscular Electrical Stimulation', 'NMES', 'neuromuscular electrostimulation (NMES) with various intensity of induced muscle contractions']","['intensive stimulation', 'VAS scores', '6-min walk test (6MWT', '6MWT distance', 'visual analogue scale']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",22.0,0.00850754,"The less intensive NMES (with achieving visible muscle contractions) was characterized by better tolerance and better compliance in elderly patients with decompensated CHF compared to the more intensive NMES (with achieving maximum contractions), but the less intensive NMES was not inferior to the more intensive NMES in effectiveness.","[{'ForeName': 'G O', 'Initials': 'GO', 'LastName': 'Veliev', 'Affiliation': 'I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow.'}, {'ForeName': 'Yu D', 'Initials': 'YD', 'LastName': 'Weissman', 'Affiliation': 'I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow.'}, {'ForeName': 'I V', 'Initials': 'IV', 'LastName': 'Patchenskaya', 'Affiliation': 'I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow.'}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Poltavskaya', 'Affiliation': 'I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow.'}]",Kardiologiia,['10.18087/cardio.2021.3.n1457'] 3582,33849403,The Effectiveness of Health Belief Model Initiative in Breast Cancer Screening Behaviors among Women Health Volunteers.,"Knowledge of screening methods and regular diagnostic tests play an important role in reducing the incidence of cancers and their mortality. We investigated the effectiveness of health belief model initiative in breast cancer screening behaviors among women health volunteers. A quasi-experimental design and non-probability sampling technique was conducted during 2019 in Abhar, Iran. Two out of six health centers were approached and each was recruited in either experimental or control group. Based on the Iranian and standardized version of the Champion's Health Belief Model Scale, the different domains of the scale and breast cancer screening behaviors of eligible women health volunteers (n = 72) were evaluated. Then, seven training sessions were designed and implemented for the intervention group using local language and different educational approaches. The participants were reevaluated according to the same questionnaire three months after the intervention. There was a meaningful difference regarding breast self-exam, knowledge, perceived susceptibility, perceived severity, perceived benefits, and perceived barriers among both the control and intervention groups before and after the intervention. Training programs using health belief model are crucial in developing breast cancer screening behaviors for women health volunteers. Thus, it is recommended that training programs should be conducted using individual behavioral models.",2021,"There was a meaningful difference regarding breast self-exam, knowledge, perceived susceptibility, perceived severity, perceived benefits, and perceived barriers among both the control and intervention groups before and after the intervention.","['eligible women health volunteers (n\xa0=\xa072', 'women health volunteers', 'Women Health Volunteers', '2019 in Abhar, Iran']","['Health Belief Model Initiative', 'intervention group using local language and different educational approaches', 'health belief model initiative']","['breast self-exam, knowledge, perceived susceptibility, perceived severity, perceived benefits, and perceived barriers']","[{'cui': 'C0080339', 'cui_str': ""Woman's Health""}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C3714363', 'cui_str': 'Health belief model'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0085105', 'cui_str': 'Breast self-examination'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]",72.0,0.0155665,"There was a meaningful difference regarding breast self-exam, knowledge, perceived susceptibility, perceived severity, perceived benefits, and perceived barriers among both the control and intervention groups before and after the intervention.","[{'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Matlabi', 'Affiliation': 'Department of Health Education and Promotion, Faculty of Health Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Asgari', 'Affiliation': 'Department of Health Education and Promotion, Faculty of Health Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shabnam', 'Initials': 'S', 'LastName': 'Morsali Asl', 'Affiliation': 'School of Psychology, Islamic Azad University, Ardabil, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Mousavi', 'Affiliation': 'Department of Biostatistics and Epidemiology, Faculty of Health Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Rezakhani Moghaddam', 'Affiliation': 'Department of Public Health, Khalkhal University of Medical Sciences, Khalkhal, Iran.'}]",Social work in public health,['10.1080/19371918.2021.1896407'] 3583,33849396,"Factors associated with primary health care providers' alcohol screening behavior in Colombia, Mexico and Peru.","Background: Screening for unhealthy alcohol use in routine consultations can aid primary health care (PHC) providers in detecting patients with hazardous or harmful consumption and providing them with appropriate care. As part of larger trial testing strategies to improve implementation of alcohol screening in PHC, this study investigated the motivational (role security, therapeutic commitment, self-efficacy) and organizational context (leadership, work culture, resources, monitoring, community engagement) factors that were associated with the proportion of adult patients screened with AUDIT-C by PHC providers in Colombia, Mexico and Peru. Additionally, the study investigated whether the effect of the factors interacted with implementation strategies and the country. Methods: Pen-and-paper questionnaires were completed by 386 providers at the start of their study participation (79% female, M age = 39.5, 37.6% doctors, 15.0% nurses, 9.6% psychologists, 37.8% other professional roles). They were allocated to one of four intervention arms: control group; short training only; short training in presence of municipal support; and standard (long) training in presence of municipal support. Providers documented their screening practice during the five-month implementation period. Data were collected between April 2019 and March 2020. Results: Negative binomial regression analysis found an inverse relationship of role security with the proportion of screened patients. Self-efficacy was associated with an increase in the proportion of screened patients only amongst Mexican providers. Support from leadership (formal leader in organization) was the only significant organizational context factor, but only in non-control arms. Conclusion: Higher self-efficacy is a relevant factor in settings where screening practice is already ongoing. Leadership support can enhance effects of implementation strategies.",2021,"Support from leadership (formal leader in organization) was the only significant organizational context factor, but only in non-control arms. ","['386 providers at the start of their study participation (79% female, M age = 39.5, 37.6% doctors, 15.0% nurses, 9.6% psychologists, 37.8% other professional roles', 'adult patients screened with AUDIT-C by PHC providers in Colombia, Mexico and Peru', 'patients with hazardous or harmful consumption and providing them with appropriate care']",['control group; short training only; short training in presence of municipal support; and standard (long) training in presence of municipal support'],['Self-efficacy'],"[{'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0205394', 'cui_str': 'Other'}, {'cui': 'C0949640', 'cui_str': 'Professional Role'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C3245499', 'cui_str': 'Colombia'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.0168175,"Support from leadership (formal leader in organization) was the only significant organizational context factor, but only in non-control arms. ","[{'ForeName': 'Daša', 'Initials': 'D', 'LastName': 'Kokole', 'Affiliation': 'Department of Health Promotion, CAPHRI Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Jané-Llopis', 'Affiliation': 'Department of Health Promotion, CAPHRI Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Liesbeth', 'Initials': 'L', 'LastName': 'Mercken', 'Affiliation': 'Department of Health Promotion, CAPHRI Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Piazza', 'Affiliation': 'School of Public Health and Administration, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Bustamante', 'Affiliation': 'School of Public Health and Administration, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Guillermina', 'Initials': 'G', 'LastName': 'Natera Rey', 'Affiliation': 'Instituto Nacional de Psiquiatría Ramón de la Fuente Muñiz, Ciudad de México, CDMX, Mexico.'}, {'ForeName': 'Perla', 'Initials': 'P', 'LastName': 'Medina', 'Affiliation': 'Instituto Nacional de Psiquiatría Ramón de la Fuente Muñiz, Ciudad de México, CDMX, Mexico.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Pérez-Gómez', 'Affiliation': 'Corporación Nuevos Rumbos, Bogotá, Colombia.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Mejía-Trujillo', 'Affiliation': 'Corporación Nuevos Rumbos, Bogotá, Colombia.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': ""O'Donnell"", 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Kaner', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Gual', 'Affiliation': 'Red de Trastornos Adictivos. Instituto Carlos III, Madrid, Spain.'}, {'ForeName': 'Christiane Sybille', 'Initials': 'CS', 'LastName': 'Schmidt', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Center for Interdisciplinary Addiction Research (ZIS), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Schulte', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Center for Interdisciplinary Addiction Research (ZIS), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Math J J M', 'Initials': 'MJJM', 'LastName': 'Candel', 'Affiliation': 'Department of Methodology & Statistics, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'de Vries', 'Affiliation': 'Department of Health Promotion, CAPHRI Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Anderson', 'Affiliation': 'Department of Health Promotion, CAPHRI Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands.'}]",Substance abuse,['10.1080/08897077.2021.1903658'] 3584,33849382,Assessment of various intralesional injections in keloid: Comparative analysis.,"AIM Intralesional triamcinolone is a gold standard in treating the keloids to comparation its effectiveness versus intralesional 5-fluorouracil intralesional verapamil and intralesional platelet-rich plasma. PATIENTS AND METHODS Several 160-cases were categorized into four groups of each Group-Containing 40 cases. Group-A (control) treated with intralesional triamcinolone and Group-B intralesional verapamil, Group-C intralesional 5-fluorouracil, and Group-D intralesional platelet-rich plasma. Patients were assessed for clinical response based on a decrease in the patient and observer scar assessment scale (POSAS) at baseline and the end of treatment. RESULTS The mean base-line POSAS score was 91 ± 10.98 SD check-in Group-A, 90 ± 10.85 in Group-B, 89 ± 10.06 in Group-C, and 92 ± 10.84 in Group-D.POSAS score after 24 weeks 36 ± 12.74 in Group-A, 29 ± 10.91 in Group-B, 39 ± 13.74 in Group-C, 36 ± 12.74 in Group-D. Statistically, a significant difference was observed between groups. CONCLUSION Intralesional verapamil reported to be the most effective therapy and platelet-rich plasma was effective as intralesional triamcinolone acetonide with no serious side effects and 5-fluorouracil was less effective in treating the keloids.",2021,Intralesional verapamil reported to be the most effective therapy and platelet-rich plasma was effective as intralesional triamcinolone acetonide with no serious side effects and 5-fluorouracil was less effective in treating the keloids.,['Several 160-cases were categorized into four groups of each Group-Containing 40 cases'],"['Intralesional verapamil', 'triamcinolone', 'intralesional triamcinolone and Group-B intralesional verapamil, Group-C intralesional 5-fluorouracil, and Group-D intralesional platelet-rich plasma', 'triamcinolone acetonide', '5-fluorouracil', 'intralesional 5-fluorouracil intralesional verapamil']","['patient and observer scar assessment scale (POSAS', 'mean base-line POSAS score']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C1512955', 'cui_str': 'Intralesional route'}, {'cui': 'C0042523', 'cui_str': 'Verapamil'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0441838', 'cui_str': 'Group D'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0367595,Intralesional verapamil reported to be the most effective therapy and platelet-rich plasma was effective as intralesional triamcinolone acetonide with no serious side effects and 5-fluorouracil was less effective in treating the keloids.,"[{'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Albalat', 'Affiliation': 'Dermatology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Nabil', 'Affiliation': 'Dermatology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Fathia', 'Initials': 'F', 'LastName': 'Khattab', 'Affiliation': 'Dermatology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}]",The Journal of dermatological treatment,['10.1080/09546634.2021.1914307'] 3585,33849367,Fixed dexmedetomidine infusion versus fixed-dose midazolam bolus as primary sedative for maintaining intra-procedural sedation during endobronchial ultrasound-guided transbronchial needle aspiration: a double blind randomized controlled trial.,"Objective : The utility and safety of fixed dexmedetomidine infusion was compared to fixed-dose midazolam bolus among patients undergoing EBUS-TBNA. Methods : In this randomized double-blind parallel-group study, 197 patients were assigned to receive dexmedetomidine (Group D, 1 µg/kg before, and 0.6 µg/kg/hour during, procedure) or midazolam (Group M, 2 mg before procedure) sedation. The primary outcome was number of rescue midazolam boluses administered to achieve Ramsay Sedation Scale (RSS) score of two or more. We also studied sedation depth during procedure, adverse hemodynamic and hypoxemic events, bronchoscopist and patient satisfaction, and time-to-discharge from recovery room. Results : Rescue midazolam requirement was significantly lesser in the 99 Group D (0.9±1.2 boluses) than in the 98 Group M (2.0±2.4 boluses), subjects. Mean RSS score was significantly higher in Group D subjects (2.5±0.7 vs. 2.3±0.7). Significantly more subjects in Group D developed hypotension (46 vs. 27) or bradycardia (37 vs. 5), but none required specific intervention. Bronchoscopists reported significantly greater overall procedure satisfaction in Group D subjects. Conclusion : Fixed dexmedetomidine infusion statistically significantly reduced need for rescue sedation during EBUS-TBNA, and allowed slightly faster post-procedure recovery, as compared to fixed-dose midazolam bolus. However, it caused hypotension and bradycardia more frequently. Clinical trial registration : www.clinicaltrials.gov identifier is NCT02713191.",2021,"Significantly more subjects in Group D developed hypotension (46 vs. 27) or bradycardia (37 vs. 5), but none required specific intervention.","['197 patients', 'patients undergoing EBUS-TBNA']","['endobronchial ultrasound-guided transbronchial needle aspiration', 'dexmedetomidine', 'fixed dexmedetomidine', 'midazolam', 'dexmedetomidine infusion versus fixed-dose midazolam']","['overall procedure satisfaction', 'rescue sedation', 'hypotension and bradycardia', 'number of rescue midazolam boluses administered to achieve Ramsay Sedation Scale (RSS) score of two or more', 'Mean RSS score', 'bradycardia', 'hypotension', 'Rescue midazolam requirement', 'adverse hemodynamic and hypoxemic events, bronchoscopist and patient satisfaction, and time-to-discharge from recovery room']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3160856', 'cui_str': 'Endobronchial ultrasound'}]","[{'cui': 'C3160856', 'cui_str': 'Endobronchial ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}, {'cui': 'C0181959', 'cui_str': 'Aspiration needle'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0559295', 'cui_str': 'Ramsay sedation scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}]",197.0,0.504824,"Significantly more subjects in Group D developed hypotension (46 vs. 27) or bradycardia (37 vs. 5), but none required specific intervention.","[{'ForeName': 'Renu', 'Initials': 'R', 'LastName': 'Kumari', 'Affiliation': 'Pulmonary Medicine department, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Kajal', 'Initials': 'K', 'LastName': 'Jain', 'Affiliation': 'Anesthesiology and Intensive Care department, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Ritesh', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Pulmonary Medicine department, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Sahajal', 'Initials': 'S', 'LastName': 'Dhooria', 'Affiliation': 'Pulmonary Medicine department, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Inderpaul Singh', 'Initials': 'IS', 'LastName': 'Sehgal', 'Affiliation': 'Pulmonary Medicine department, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Ashutosh Nath', 'Initials': 'AN', 'LastName': 'Aggarwal', 'Affiliation': 'Pulmonary Medicine department, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}]",Expert review of respiratory medicine,['10.1080/17476348.2021.1918000'] 3586,33849353,The effect of physical activity with and without cognitive demand on the improvement of executive functions and behavioral symptoms in children with ADHD.,"Background : Purposeful physical activities improve cognitive functions. Two possible mechanisms are available for this intervention including the impact of the physical component of exercise and goal-directedness as a cognitive component. In the present study, we aimed to compare the effect of physical activity with and without cognitive demand on executive functions and behavioral symptoms in children with ADHD. Methods : Thirty children with ADHD were randomly assigned to two equal groups of physical activity training with and without cognitive demand. Exercise for cognitive improvement and rehabilitation (EXCIR) or running, as an aerobic exercise, were used for intervention in two groups. Executive functions and ADHD symptoms were measured in three sessions including baseline, post-intervention, and follow-up assessments, using 1-back, Wisconsin Card Sorting, and Go/No-Go tests and Conner's Teacher and Parent Rating scales. Repeated measures ANOVAs were used for analysis. Results : The results showed physical activity with cognitive demand, compared to the physical activity without cognitive demand, has a better and longer impact on the improvement of executive functions and ADHD symptoms. Conclusions : Cognitive rehabilitation with combined physical and cognitive tasks has a beneficial and lasting impact on impaired executive functions and behavioral symptoms in children with ADHD.",2021,Cognitive rehabilitation with combined physical and cognitive tasks has a beneficial and lasting impact on impaired executive functions and behavioral symptoms in children with ADHD.,"['Thirty children with ADHD', 'children with ADHD']","['physical activity with and without cognitive demand', 'Cognitive rehabilitation with combined physical and cognitive tasks', 'physical activity training with and without cognitive demand']","['Executive functions and ADHD symptoms', ""No-Go tests and Conner's Teacher and Parent Rating scales"", 'executive functions and behavioral symptoms', 'executive functions and ADHD symptoms']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}]",30.0,0.00870147,Cognitive rehabilitation with combined physical and cognitive tasks has a beneficial and lasting impact on impaired executive functions and behavioral symptoms in children with ADHD.,"[{'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Nejati', 'Affiliation': 'Department of Psychology, Shahid Beheshti University, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Derakhshan', 'Affiliation': 'Department of Psychology, Shahid Beheshti University, Tehran, Iran.'}]",Expert review of neurotherapeutics,['10.1080/14737175.2021.1912600'] 3587,33849341,Focal Therapy is a viable treatment for low risk Prostate cancer.,"Focal therapy (FT) is a promising alternative to definitive therapy for localized prostate cancer (PCa). Rather than simply monitoring cancer through active surveillance (AS) or risking the side effects of robotic radical prostatectomy (RP) it offers an intermediate solution. Azzouzi et al. examined vascular-targeted photodynamic therapy (PDT) for PCa. In this randomized, controlled clinical trial, patients with low-risk and localized PCa with no prior treatment were either assigned to a group undergoing vascular-targeted photodynamic therapy or to another group undergoing AS. Participants in the PDT group had a longer median disease progression time, lower proportion of disease progression at 24 months after treatment, and a higher proportion of negative biopsies at 24 months after treatment than the patients in the AS group. Use of PDT was associated with almost a five-fold decrease in reduction of use of definitive therapy. Cryoablation and high intensity focused ultrasound (HIFU) are additional forms of FT for localized PCa. They have been associated with a 5-year metastasis-free survival rate of up to 98% in low or intermediate risk patients. Patients undergoing salvage RP after FT may also see benefits compared to those who undergo RP after radiation therapy (RT). Ribiero et al. compared toxicity and oncological outcomes of patients who underwent salvage RP (sRP) after FT with those who underwent sRP after RT. Patients who underwent sRP after FT were found to have better continence at 12 months after surgery, almost 3 times less the rate of positive surgical margins, and lower postoperative complication rates within the first 30 days of surgery than those who had sRP after undergoing RT. Methods of FT including PDT, HIFU, and cryoablation provide an intermediate treatment option between AS and RP. Further research should be conducted to look into the potential benefits of FT for localized PCa.",2021,"Participants in the PDT group had a longer median disease progression time, lower proportion of disease progression at 24 months after treatment, and a higher proportion of negative biopsies at 24 months after treatment than the patients in the AS group.","['patients with low-risk and localized PCa with no prior treatment', 'patients who underwent salvage RP ', 'low risk Prostate cancer']","['robotic radical prostatectomy (RP', 'vascular-targeted photodynamic therapy or to another group undergoing AS', 'Cryoablation and high intensity focused ultrasound (HIFU', 'photodynamic therapy (PDT', 'Focal Therapy', 'Focal therapy (FT']","['toxicity and oncological outcomes', 'negative biopsies', 'rate of positive surgical margins', 'postoperative complication rates', 'longer median disease progression time', '5-year metastasis-free survival rate', 'disease progression', 'sRP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0010408', 'cui_str': 'Cryosurgery'}, {'cui': 'C0441583', 'cui_str': 'High intensity focused ultrasound'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}]",,0.129041,"Participants in the PDT group had a longer median disease progression time, lower proportion of disease progression at 24 months after treatment, and a higher proportion of negative biopsies at 24 months after treatment than the patients in the AS group.","[{'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Berends', 'Affiliation': 'University of Michigan, Department of Urology, Ann Arbor, Michigan, United States; berendsj@med.umich.edu.'}, {'ForeName': 'Ajith', 'Initials': 'A', 'LastName': 'Dupati', 'Affiliation': 'University of Michigan, 1259, Department of Urology, Ann Arbor, Michigan, United States; dupatiaj@umich.edu.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Dibianco', 'Affiliation': 'University of Michigan, Department of Urology, Ann Arbor, United States; dibianco@med.umich.edu.'}, {'ForeName': 'Arvin K', 'Initials': 'AK', 'LastName': 'George', 'Affiliation': 'University of Michigan, 1259, Department of Urology, Ann Arbor, Michigan, United States; arvigeor@med.umich.edu.'}]",Journal of endourology,['10.1089/end.2021.0235'] 3588,33849224,Effect of Benson's relaxation techniques on blood glucose levels in patients with diabetes mellitus.,This study aimed to determine the effect of Benson's relaxation techniques on blood glucose levels in patients with diabetes mellitus. This study is a quasi-experiment using a pre/posttest design with a control group. A sample of 30 individuals at risk of diabetes was divided into intervention and control groups. Analyses were performed using frequency distribution and the Wilcoxon signed-rank test. Significant differences were found between the pre- and post-workout measurements in the intervention group (p=0.001) but not in the control group (p=0.291). Progressive muscle relaxation exercises comprised of 15min of movement at least three days a week can improve blood sugar levels and may help to improve a patient's belief.,2021,Significant differences were found between the pre- and post-workout measurements in the intervention group (p=0.001) but not in the control group (p=0.291).,"['30 individuals at risk of diabetes', 'patients with diabetes mellitus']","[""Benson's relaxation techniques"", 'Progressive muscle relaxation exercises']","['blood sugar levels', 'blood glucose levels']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0035029', 'cui_str': 'Relaxation technique'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}]",30.0,0.00951016,Significant differences were found between the pre- and post-workout measurements in the intervention group (p=0.001) but not in the control group (p=0.291).,"[{'ForeName': 'Zahrah Maulidia', 'Initials': 'ZM', 'LastName': 'Septimar', 'Affiliation': 'Faculty of Nursing STIKes Yatsi, Tangerang, Banten, Indonesia. Electronic address: zahrahmaulidia@stikesyatsi.ac.id.'}, {'ForeName': 'Heri', 'Initials': 'H', 'LastName': 'Priatna', 'Affiliation': 'Faculty of Nursing STIKes Yatsi, Tangerang, Banten, Indonesia.'}, {'ForeName': 'Somali Yuda', 'Initials': 'SY', 'LastName': 'Tomi', 'Affiliation': 'Faculty of Nursing STIKes Yatsi, Tangerang, Banten, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2020.09.044'] 3589,33849218,Does prenatal massage reduce severe pain of mother in active labour?,"This study aims to explain the relationship between prenatal massage with the level of pain in mothers in active labor. A one group pre-test and post-test quasi-experimental were conducted. Respondents are a mother (n=40) who having active labor in public health services were divide into two groups, control (n=20) and intervention groups (n=20). Efflurage technic was conducted to message about 10-15min each mother when having contraction until delivered her baby for intervention groups. A visual analog scale and Numeric rating scale was used to measure pain. After prenatal massage, the pain score of mother in intervention groups decreased from 7.65 to 4.35 (Z 0.001) compare to control groups pain scores are 6.45 to 7.15. Massage for mothers in active labor, one of can be alternate to reduce severe pain. This intervention is also make the mother more relaxed and calm. The midwife should do this massage in active labor.",2021,"After prenatal massage, the pain score of mother in intervention groups decreased from 7.65 to 4.35 (Z 0.001) compare to control groups pain scores are 6.45 to 7.15.","['mothers in active labor', 'Respondents are a mother (n=40) who having active labor in public health services']",['Massage'],"['visual analog scale and Numeric rating scale', 'severe pain', 'pain scores', 'pain score']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0233081', 'cui_str': 'Normal labor'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0041734', 'cui_str': 'United States. Public Health Service'}]","[{'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",40.0,0.0349867,"After prenatal massage, the pain score of mother in intervention groups decreased from 7.65 to 4.35 (Z 0.001) compare to control groups pain scores are 6.45 to 7.15.","[{'ForeName': 'Lastri Mei', 'Initials': 'LM', 'LastName': 'Winarni', 'Affiliation': 'Midwifery Program, Yatsi Nursing & Midwifery School, Tangerang, Banten, Indonesia. Electronic address: lastri@stikesyatsi.ac.id.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Nuryanti', 'Affiliation': 'Midwifery Program, Yatsi Nursing & Midwifery School, Tangerang, Banten, Indonesia.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Wibisono', 'Affiliation': 'Nursing Program, Yatsi Nursing & Midwifery School, Tangerang, Banten, Indonesia.'}, {'ForeName': 'Novita', 'Initials': 'N', 'LastName': 'Sari', 'Affiliation': 'Midwifery Program, Yatsi Nursing & Midwifery School, Tangerang, Banten, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2020.09.041'] 3590,33849208,The effects of thought stopping on anxiety levels in adolescents living in earthquake-prone areas.,"The objective of the study is to determine the effect of thought-stopping therapy on anxiety levels in adolescents living in earthquake-prone areas. This study used quasi-experiment pre-post test with control group, conducted in one of the earthquake-prone areas city in East Java. 112 respondents (the control and the intervention group) were included in the research. Both groups received nursing intervention. In addition to the nursing intervention, the intervention group was asked to use thought-stopping techniques. The HAM-A questionnaire was used to determine anxiety levels. A significant decrease in anxiety in both the control and intervention groups was demonstrated in the present study after the intervention. The intervention group experienced a decrease in the anxiety rating of 5.54, compared to the corresponding decrease in the control group of 2.79. Nursing intervention and thought-stopping are recommended as effective in reducing anxiety in adolescents living in earthquake-prone areas.",2021,"The intervention group experienced a decrease in the anxiety rating of 5.54, compared to the corresponding decrease in the control group of 2.79.","['adolescents living in earthquake-prone areas', '112 respondents (the control and the intervention group) were included in the research', 'one of the earthquake-prone areas city in East Java']","['nursing intervention', 'Nursing intervention']","['anxiety rating', 'anxiety levels', 'anxiety']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0013463', 'cui_str': 'Earthquake'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0205803', 'cui_str': 'Java'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]",,0.00433384,"The intervention group experienced a decrease in the anxiety rating of 5.54, compared to the corresponding decrease in the control group of 2.79.","[{'ForeName': 'Yunita Astriani', 'Initials': 'YA', 'LastName': 'Hardayati', 'Affiliation': 'Faculty of Nursing, Universitas Indonesia, Depok, West Java, Indonesia; Sint Carolus School of Health Sciences, Jakarta, Indonesia.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Mustikasari', 'Affiliation': 'Faculty of Nursing, Universitas Indonesia, Depok, West Java, Indonesia. Electronic address: mustikasari@ui.ac.id.'}, {'ForeName': 'Ria Utami', 'Initials': 'RU', 'LastName': 'Panjaitan', 'Affiliation': 'Faculty of Nursing, Universitas Indonesia, Depok, West Java, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2021.01.001'] 3591,33849205,Reducing anxiety level by using progressive relaxation among the elderly people in the nursing home.,"The prevalence of anxiety in the elderly is very high. Anxiety in the elderly is characterized by sleep disturbances, withdrawal and isolating behavior, and other compulsive behaviors. One form of behavior therapy is relaxation techniques. To determine the effect of progressive relaxation on reducing anxiety levels in the elderly in the nursing home. This study is quantitative with a quasi-experimental method. The study was conducted at the Dharma Bhakti Nursing Home in Surakarta in March 2019. The sample consisted of 17 elderly assigned to the experimental group and 17 elderly for the control group. The anxiety instrument used was Hamilton Anxiety Rating Scale (HARS), and the tools used for relaxation were backrests or beds. The average results of the experimental group pre (17.29) post (7.24) p-value (0.001), the control group pre-mean (14.18), post (14.47) p-value (0.289). Progressive relaxation has a significant influence on reducing anxiety levels on the elderly.",2021,Progressive relaxation has a significant influence on reducing anxiety levels on the elderly.,"['elderly in the nursing home', '17 elderly assigned to the experimental group and 17 elderly for the control group', 'elderly people in the nursing home', 'Dharma Bhakti Nursing Home in Surakarta in March 2019']",['progressive relaxation'],"['Hamilton Anxiety Rating Scale (HARS', 'anxiety levels', 'anxiety level']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0454043', 'cui_str': 'Jacobson technique'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]",17.0,0.00591523,Progressive relaxation has a significant influence on reducing anxiety levels on the elderly.,"[{'ForeName': 'Wachidah', 'Initials': 'W', 'LastName': 'Yuniartika', 'Affiliation': 'Community and Gerontology Nursing Department, School of Nursing, Faculty of Health Science, Universitas Muhammadiyah Surakarta, Central Java, Indonesia. Electronic address: wachidah.yuniartika@ums.ac.id.'}, {'ForeName': 'Agus', 'Initials': 'A', 'LastName': 'Sudaryanto', 'Affiliation': 'Community and Gerontology Nursing Department, School of Nursing, Faculty of Health Science, Universitas Muhammadiyah Surakarta, Central Java, Indonesia.'}, {'ForeName': 'Arifah Zanuar', 'Initials': 'AZ', 'LastName': 'Kumalasari', 'Affiliation': 'Nursing Department, School of Nursing, Faculty of Health Science, Universitas Muhammadiyah Surakarta, Central Java, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2020.09.030'] 3592,33849166,"Female health education package enhances knowledge, attitudes, and self-efficacy of housewives in cervical cancer screening.","This research was conducted to identify the effectiveness of FEMALE health education on the knowledge, attitudes, and self-efficacy of women in the Banjarbaru Selatan District, Banjarbaru. The quasi experimental pre-post test with control group design. Study was carried out on 428 housewives, 213 as control groups and 215 as intervention groups respectively. The sampling technique used convenience sampling. The results showed that there was a significant differences before and after intervention in knowledge, attitudes, and self-efficacy in women (p=0.000, p=0.003, and p=0.002 respectively) in the intervention group which is also significant different from respondent in the control group. This study recommends that nurses could use this FEMALE health education to educate women in the community in order to improve the coverage of cervical cancer screening.",2021,"The results showed that there was a significant differences before and after intervention in knowledge, attitudes, and self-efficacy in women (p=0.000, p=0.003, and p=0.002 respectively) in the intervention group which is also significant different from respondent in the control group.","['428 housewives, 213 as control groups and 215 as intervention groups respectively', 'women in the Banjarbaru Selatan District, Banjarbaru']",[],"['knowledge, attitudes, and self-efficacy']","[{'cui': 'C4517775', 'cui_str': '428'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",428.0,0.0124923,"The results showed that there was a significant differences before and after intervention in knowledge, attitudes, and self-efficacy in women (p=0.000, p=0.003, and p=0.002 respectively) in the intervention group which is also significant different from respondent in the control group.","[{'ForeName': 'Fitri Ayatul', 'Initials': 'FA', 'LastName': 'Azlina', 'Affiliation': 'Faculty of Nursing Universitas Indonesia, Depok, West Java, Indonesia.'}, {'ForeName': 'Setyowati', 'Initials': 'S', 'LastName': 'Setyowati', 'Affiliation': 'Faculty of Nursing Universitas Indonesia, Depok, West Java, Indonesia. Electronic address: wati123@ui.ac.id.'}, {'ForeName': 'Tri', 'Initials': 'T', 'LastName': 'Budiati', 'Affiliation': 'Faculty of Nursing Universitas Indonesia, Depok, West Java, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2020.12.025'] 3593,33849156,Henderson's approach in nursing discharge planning to improve patient satisfaction.,The purpose of this study was to identify the effect of discharge planning management intervention on patient satisfaction and the role of nurses at the hospital. This study was a quasi-experimental study with 92 respondents. The intervention group was given a discharge planning management intervention by adding Blaylock Risk Assessment Screening Score (BRASS) and the control group was given discharge planning according to what was done in the hospital. Both groups measured patient satisfaction and role of nurses before and after the intervention. The results showed that discharge planning management intervention in the intervention group increasing patient satisfaction at the hospital (p=0.002) and the role of nurses especially in fulfilling 14 basic needs of humans (Henderson's Approach). Discharge Planning Management Intervention effectively increases patient satisfaction and the role of nurses.,2021,The results showed that discharge planning management intervention in the intervention group increasing patient satisfaction at the hospital (p=0.002) and the role of nurses especially in fulfilling 14 basic needs of humans (Henderson's Approach).,['92 respondents'],"['Discharge Planning Management Intervention', 'discharge planning management intervention by adding Blaylock Risk Assessment Screening Score (BRASS) and the control group was given discharge planning', 'discharge planning management intervention']","['patient satisfaction and role of nurses', 'patient satisfaction']","[{'cui': 'C0282122', 'cui_str': 'Respondents'}]","[{'cui': 'C0012622', 'cui_str': 'Discharge planning'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]",,0.0157435,The results showed that discharge planning management intervention in the intervention group increasing patient satisfaction at the hospital (p=0.002) and the role of nurses especially in fulfilling 14 basic needs of humans (Henderson's Approach).,"[{'ForeName': 'Dyah Fitri', 'Initials': 'DF', 'LastName': 'Wulandari', 'Affiliation': 'Faculty of Nursing Universitas Indonesia, Depok, West Java, Indonesia; Depok Regional General Hospital, Depok, West Java, Indonesia.'}, {'ForeName': 'Rr Tutik', 'Initials': 'RT', 'LastName': 'Sri Hariyati', 'Affiliation': 'Faculty of Nursing Universitas Indonesia, Depok, West Java, Indonesia. Electronic address: tutik@ui.ac.id.'}, {'ForeName': 'Kuntarti', 'Initials': 'K', 'LastName': 'Kuntarti', 'Affiliation': 'Faculty of Nursing Universitas Indonesia, Depok, West Java, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2020.12.016'] 3594,33849155,Family psychoeducation (FPE) therapy for family anxiety in caring for family members with mental disorders.,Families experience various kinds of problems and problems in caring for family members whose families experience various obstacles in treating a patient with mental disorders. One condition that is felt is anxiety. Anxiety is related to ignorance regarding the patient's condition; earn a living; demands to divide time. The role of the family becomes very important because the patient lives in the middle of the family. Families need knowledge in managing patients both when treated at the hospital and when returning home. The purpose of this study was to determine the effect of family psychoeducation (FPE) therapy on family anxiety in treating a patient with mental disorders. The design used a quasi-experiment with the pre-test and post-test with control group methods. The sample was 100 respondents (50 experimental groups and 50 control groups). The results of the study showed a significant effect of FPE on family anxiety with a p-value of 0.00 (p<0.05). It was concluded that FPE therapy effectively reduced family anxiety in treating a patient with mental disorders.,2021,The results of the study showed a significant effect of FPE on family anxiety with a p-value of 0.00 (p<0.05).,"['family anxiety in treating a patient with mental disorders', 'family anxiety in caring for family members with mental disorders']","['FPE', 'family psychoeducation (FPE) therapy', 'Family psychoeducation (FPE) therapy', 'FPE therapy']",['family anxiety'],"[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0580931', 'cui_str': 'In care'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0098101,The results of the study showed a significant effect of FPE on family anxiety with a p-value of 0.00 (p<0.05).,"[{'ForeName': 'Dwi Heppy', 'Initials': 'DH', 'LastName': 'Rochmawati', 'Affiliation': 'Faculty of Nursing, Universitas Islam Sultan Agung, Semarang, Indonesia. Electronic address: dwiheppy@unissula.ac.id.'}, {'ForeName': 'Ahmadi Nuh', 'Initials': 'AN', 'LastName': 'Huda', 'Affiliation': 'Faculty of Medicine, Universitas Islam Sultan Agung, Semarang, Indonesia.'}, {'ForeName': 'Joko', 'Initials': 'J', 'LastName': 'Kuncoro', 'Affiliation': 'Faculty of Psychology, Universitas Islam Sultan Agung, Semarang, Indonesia.'}, {'ForeName': 'Wahyu Endang', 'Initials': 'WE', 'LastName': 'Setyowati', 'Affiliation': 'Faculty of Nursing, Universitas Islam Sultan Agung, Semarang, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2020.12.015'] 3595,33849138,Effects of music therapy on physiological outcomes for post-operative total knee arthroplasty (TKA) patients.,"This study aimed to investigate the effects of music on physiological outcomes for post-operative TKA patients in the recovery unit. Fifty-six patients from Hospital Melaka were randomized equally into intervention (IG) and control groups (CG). IG received the usual care and listened to selected music for 60min, while the CG received only the usual care. Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), respiration rate (RR) and oxygen saturation (SpO 2 ) were measured on arrival and after 10, 20, 30, and 60min in the recovery unit. A significant difference between groups was observed in RR upon arrival (U=276.5, p=0.029) and after 10min (U=291, p=0.45). Meanwhile, there were significant differences in DBP (F=3.158, p=0.032), RR (χ 2 =15.956, p=0.003) and SpO 2 (χ 2 =14.084, p=0.007) over time in the IG. Overall, listening to music immediately after TKA has an effect on DBP, RR, and SpO 2 .",2021,"A significant difference between groups was observed in RR upon arrival (U=276.5, p=0.029) and after 10min (U=291, p=0.45).","['Fifty-six patients from Hospital Melaka', 'post-operative total knee arthroplasty (TKA) patients']","['music therapy', 'usual care and listened to selected music for 60min, while the CG received only the usual care']","['physiological outcomes', 'DBP', 'Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), respiration rate (RR) and oxygen saturation (SpO 2 ', 'RR upon arrival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}]",56.0,0.0694406,"A significant difference between groups was observed in RR upon arrival (U=276.5, p=0.029) and after 10min (U=291, p=0.45).","[{'ForeName': 'Aishairma', 'Initials': 'A', 'LastName': 'Aris', 'Affiliation': 'Department of Nursing, Universiti Kebangsaan Malaysia, Cheras, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Suliza', 'Initials': 'S', 'LastName': 'Sulaiman', 'Affiliation': 'Department of Nursing, Universiti Kebangsaan Malaysia, Cheras, Kuala Lumpur, Malaysia; Institut Latihan Kementerian Kesihatan Malaysia (ILKKM) Melaka (Kejururawatan), Melaka, Malaysia. Electronic address: suliza.bal@gmail.com.'}, {'ForeName': 'Muhammad Kamil', 'Initials': 'MK', 'LastName': 'Che Hasan', 'Affiliation': 'Department of Medical-Surgical Nursing, Kulliyyah of Nursing, International Islamic University Malaysia, Kuantan, Pahang, Malaysia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2020.10.006'] 3596,33849123,Analysis of the effect of infection prevention nursing on drainage of malignant pleural effusion with indwelling central venous catheter.,"BACKGROUND The aim of this study was to explore the effect of infection prevention care on the drainage of malignant pleural effusion (MPE) by indwelling Central venous catheterization (CVC). METHODS From January 2016 to January 2018, 128 patients at our hospital who needed indwelling CVC for drainage of MPE were randomly divided into an infection prevention group and a conventional group. The corresponding nursing plan was given to compare the 2 groups in several measures, including nursing effect and complications. RESULTS After intervention, the total effective rate of the infection prevention group was 96.88%, while the total effective rate of the conventional group was 87.50%, which was a statistically significant difference (P<0.05). The disappearance time of pleural effusion, catheter indwelling time, and length of stay in the infection prevention group were significantly lower than those in the conventional group (P<0.05). The incidence of infection and the total incidence of all complications in the infection prevention group were significantly lower than those in the conventional group (P<0.05). The proportion of the number of cases with Karnofsky Performance Scale (KPS) ≤10 in the infection prevention group was significantly lower than that in the conventional group (P<0.05). CONCLUSIONS As infection prevention care significantly improves clinical efficacy and reduces the occurrence of complications, it uses in clinic is warranted.",2021,The incidence of infection and the total incidence of all complications in the infection prevention group were significantly lower than those in the conventional group (P<0.05).,"['From January 2016 to January 2018, 128 patients at our hospital who needed indwelling CVC for drainage of MPE', 'malignant pleural effusion with indwelling central venous catheter']","['infection prevention care', 'indwelling Central venous catheterization (CVC', 'infection prevention nursing', 'infection prevention group and a conventional group']","['incidence of infection and the total incidence of all complications', 'clinical efficacy', 'total effective rate', 'proportion of the number of cases with Karnofsky Performance Scale (KPS', 'disappearance time of pleural effusion, catheter indwelling time, and length of stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0439848', 'cui_str': 'Indwelling'}, {'cui': 'C0007435', 'cui_str': 'Central venous catheterisation'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0080032', 'cui_str': 'Neoplastic pleural effusion'}, {'cui': 'C1145640', 'cui_str': 'Central venous catheter'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0439848', 'cui_str': 'Indwelling'}, {'cui': 'C0007435', 'cui_str': 'Central venous catheterisation'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky performance status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032227', 'cui_str': 'Pleural effusion'}, {'cui': 'C0007439', 'cui_str': 'In-Dwelling Catheters'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.0223719,The incidence of infection and the total incidence of all complications in the infection prevention group were significantly lower than those in the conventional group (P<0.05).,"[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Critical Care Medicine, Zhuji Affiliated Hospital of Shaoxing University, Zhuji, China.'}, {'ForeName': 'Lijin', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': 'Operating Room, Zhuji Maternal and Child Health Hospital, Zhuji, China.'}, {'ForeName': 'Qinna', 'Initials': 'Q', 'LastName': 'Mao', 'Affiliation': 'Department of Critical Care Medicine, Zhuji Affiliated Hospital of Shaoxing University, Zhuji, China.'}, {'ForeName': 'Guifei', 'Initials': 'G', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiothoracic Surgery, Zhuji Affiliated Hospital of Shaoxing University, Zhuji, China.'}, {'ForeName': 'Hualiang', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Critical Care Medicine, Zhuji Affiliated Hospital of Shaoxing University, Zhuji, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Xuan', 'Affiliation': 'Department of Critical Care Medicine, Zhuji Affiliated Hospital of Shaoxing University, Zhuji, China. 573589215@qq.com.'}]",Annals of palliative medicine,['10.21037/apm-21-532'] 3597,33849121,Correlation between small intestinal bacterial overgrowth and irritable bowel syndrome and the prognosis of treatment.,"BACKGROUND The aim of the present study was to analyze the relationship between small intestinal bacterial overgrowth (SIBO) and irritable bowel syndrome (IBS) and the prognosis of treatment. METHODS A total of127 IBS patients (IBS group) were selected, and based on the results of the methane/hydrogen breath test, they were divided into SIBO-positive group (subdivided into the antibiotic group, microecological group, and placebo group according to difference in treatment methods) and the SIBO-negative group. The incidence of SIBO and inflammatory factors in different populations were compared. Moreover, differences in the negative conversion rate of intestinal bacterial overgrowth, symptom improvement, interleukin (IL)-1β, and IL-10 levels in the antibiotic group, microecological group, and placebo group before and after treatment were compared. RESULTS The IL-1β level of the IBS group was higher than that of the control group, but the level of IL-10 was lower than that of the control group (P<0.05). The level of IL-1β in the SIBO-positive group was higher than that in the SIBO-negative group, while IL-10 level was lower in the SIBO-positive group compared with the SIBO-negative group (P<0.05). Symptom scores after treatment in the antibiotic group and the microecological group were lower than those in the same groups before treatment and those in the placebo group after treatment (P<0.05). After treatment, the level of IL-1β in the antibiotic group and the microecological group decreased, whereas the level of IL-10 increased (P<0.05). Furthermore, the total clinical effective rate and negative conversion rate of the antibiotic group and the microecological group were higher than those of the placebo group (P<0.05); however, the comparison of symptom scores, inflammatory factors, and total clinical effective rate before and after treatment in the placebo group was not statistically significant (P<0.05). The symptom score after treatment in the negative conversion group was lower than that in the non-negative conversion group (P<0.05). CONCLUSIONS SIBO plays an important role in the occurrence of IBS. Antibiotics and microecological agents can be used to correct SIBO in clinical practice to improve the symptoms of IBS patients and peripheral blood inflammatory factors.",2021,Symptom scores after treatment in the antibiotic group and the microecological group were lower than those in the same groups before treatment and those in the placebo group after treatment (P<0.05).,"['A total of127 IBS patients (IBS group) were selected, and based on the results of the methane/hydrogen breath test, they were divided into SIBO-positive group (subdivided into the']","['antibiotic group, microecological group, and placebo', 'placebo', 'SIBO-negative group']","['level of IL-10', 'Symptom scores', 'IL-10 level', 'small intestinal bacterial overgrowth (SIBO) and irritable bowel syndrome (IBS', 'symptom scores, inflammatory factors, and total clinical effective rate', 'negative conversion rate of intestinal bacterial overgrowth, symptom improvement, interleukin (IL)-1β, and IL-10 levels', 'level of IL-1β', 'IL-1β level', 'total clinical effective rate and negative conversion rate', 'incidence of SIBO and inflammatory factors', 'symptom score']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0025617', 'cui_str': 'Methane'}, {'cui': 'C0344439', 'cui_str': 'Hydrogen breath test'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C3160854', 'cui_str': 'Small intestinal bacterial overgrowth'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3160854', 'cui_str': 'Small intestinal bacterial overgrowth'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3160854', 'cui_str': 'Small intestinal bacterial overgrowth'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0151521', 'cui_str': 'Bacterial resistance'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.104467,Symptom scores after treatment in the antibiotic group and the microecological group were lower than those in the same groups before treatment and those in the placebo group after treatment (P<0.05).,"[{'ForeName': 'Xuelian', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': ""Department of Geriatric Medicine, Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, China; Chinese Academy of Sciences Sichuan Translational Medicine Research Hospital, Chengdu, China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Geriatric Medicine, Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, China; Chinese Academy of Sciences Sichuan Translational Medicine Research Hospital, Chengdu, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xiang', 'Affiliation': ""Chinese Academy of Sciences Sichuan Translational Medicine Research Hospital, Chengdu, China; Department of Anorectal Surgery, Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, China. xiangfeng20210105@163.com.""}, {'ForeName': 'Jingjuan', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': ""Chinese Academy of Sciences Sichuan Translational Medicine Research Hospital, Chengdu, China; Department of Anorectal Surgery, Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, China. fengjingjuan2021@163.com.""}]",Annals of palliative medicine,['10.21037/apm-21-427'] 3598,33849118,A randomised trial on the therapeutic effectiveness of bronchoalveolar lavage under fiberoptic bronchoscopy in patients with severe lung infection living in the Tibetan plateau area.,"BACKGROUND People living in plateau areas are prone to upper respiratory tract infections and secondary lung infections. The current study aimed to explore the effects of bronchoalveolar lavage under fiberoptic bronchoscope for the treatment of patients with severe pulmonary infection living in plateau areas. METHODS 148 patients with severe lung infection admitted to the intensive care unit of Shigatse People's Hospital (Shigatse, Tibet Autonomous Region, China) between July 2019 and January 2021 were enrolled. Patients were randomly assigned to the observational group or the control group. For all patients, basic clinical data including sex, age, body mass index (BMI), blood pressure, diabetes history, stroke history, presence or absence of chronic obstructive pulmonary disease, lung infection (gram-positive bacterial infection, gram-negative bacterial infection, fungal infection, acute lung abscess), surgical history, and postoperative inhalation injury. were collected. The control group received conventional treatment, and the observational group received bronchoalveolar lavage under fiberoptic bronchoscopy. Pearson's correlation was used to analyze the correlations between bronchoalveolar lavage under fiberoptic bronchoscopy and inflammatory factors levels. Logistic regression was used to investigate the correlation between bronchoalveolar lavage under fiberoptic bronchoscopy and the effectiveness of the treatment. RESULTS Before treatment, no significant difference existed in the basic data of the observational group and the control group. After treatment, the parameters of respiratory mechanics and inflammatory factors in the 2 groups were significantly improved compared with those before treatment (P<0.05). At the same time, in the observational group, the clinical parameters were significantly higher than those of the control group, and the levels of inflammatory factors were significantly lower than those of the control group (all P<0.05). After full adjustment for age, sex, BMI, gram-negative infection, diabetes, and acute lung abscess, compared with the control group, the therapeutic effectiveness in the observational group was increased by 23% (OR =1.23, 95% CI: 1.09-1.51, P=0.007). CONCLUSIONS For patients with severe lung infection who are resident in high altitude areas, compared with conventional treatments, bronchoalveolar lavage under fiberoptic bronchoscopy can significantly improve chest, lung, and total dynamic compliance, as well as reduce the levels of the inflammatory factors procalcitonin (PCT) and transforming growth factor-β, thus increasing the effectiveness of the treatment.",2021,"After treatment, the parameters of respiratory mechanics and inflammatory factors in the 2 groups were significantly improved compared with those before treatment (P<0.05).","['patients with severe lung infection living in the Tibetan plateau area', 'patients with severe lung infection who are resident in high altitude areas', ""148 patients with severe lung infection admitted to the intensive care unit of Shigatse People's Hospital (Shigatse, Tibet Autonomous Region, China) between July 2019 and January 2021 were enrolled"", 'patients with severe pulmonary infection living in plateau areas', 'For all patients, basic clinical data including sex, age, body mass index (BMI), blood pressure, diabetes history, stroke history, presence or absence of chronic obstructive pulmonary disease, lung infection (gram-positive bacterial infection, gram-negative bacterial infection, fungal infection, acute lung abscess), surgical history, and postoperative inhalation injury. were collected']","['bronchoalveolar lavage under fiberoptic bronchoscopy', 'bronchoalveolar lavage under fiberoptic bronchoscope', 'conventional treatment']","['parameters of respiratory mechanics and inflammatory factors', 'therapeutic effectiveness', 'chest, lung, and total dynamic compliance', 'levels of inflammatory factors']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0876973', 'cui_str': 'Infectious disease of lung'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0238617', 'cui_str': 'High altitude'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0040182', 'cui_str': 'Tibet'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0085426', 'cui_str': 'Bacterial Infections, Gram-Positive'}, {'cui': 'C0085423', 'cui_str': 'Disease due to Gram-negative bacteria'}, {'cui': 'C0026946', 'cui_str': 'Mycosis'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0024110', 'cui_str': 'Abscess of lung'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0745334', 'cui_str': 'Inhalation injury'}]","[{'cui': 'C1535502', 'cui_str': 'Bronchoalveolar lavage'}, {'cui': 'C0189391', 'cui_str': 'Fiberoptic bronchoscopy'}, {'cui': 'C0179433', 'cui_str': 'Flexible bronchoscope'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0428690', 'cui_str': 'Total dynamic compliance'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",148.0,0.0183846,"After treatment, the parameters of respiratory mechanics and inflammatory factors in the 2 groups were significantly improved compared with those before treatment (P<0.05).","[{'ForeName': 'Wugang', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': ""Department of Emergency, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Chi', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': ""Department of Anesthesiology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Xuqin', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Intensive Care Unit, Shigatse People's Hospital, Shigatse, Tibet Autonomous Region, China.""}, {'ForeName': 'Ningning', 'Initials': 'N', 'LastName': 'Shi', 'Affiliation': ""Department of Intensive Care Unit, Shigatse People's Hospital, Shigatse, Tibet Autonomous Region, China.""}, {'ForeName': 'Wangmu', 'Initials': 'W', 'LastName': 'Quyang', 'Affiliation': ""Department of Intensive Care Unit, Shigatse People's Hospital, Shigatse, Tibet Autonomous Region, China.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Tu', 'Affiliation': ""Department of Intensive Care Unit, Shigatse People's Hospital, Shigatse, Tibet Autonomous Region, China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Xin', 'Affiliation': ""Department of Intensive Care Unit, Shigatse People's Hospital, Shigatse, Tibet Autonomous Region, China.""}, {'ForeName': 'Lv', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': ""Department of Intensive Care Unit, Shigatse People's Hospital, Shigatse, Tibet Autonomous Region, China. jilv_1907@163.com.""}]",Annals of palliative medicine,['10.21037/apm-21-470'] 3599,33849113,"Effects of high-flux hemodialysis combined with levocarnitine on vascular calcification, microinflammation, hepcidin, and malnutrition of elderly patients on maintenance hemodialysis.","BACKGROUND This study was to investigate the effect of high-flux hemodialysis (HD) combined with levocarnitine on vascular calcification, microinflammation, hepcidin, and malnutrition in elderly patients on maintenance HD (MHD). METHODS 75 MHD elderly patients admitted to hospital between 1st September 2017 and 31st August 2019 were selected as the study subjects. They were randomly divided by digital table into three groups: low-flux group (n=25), high-flux group (n=25) and joint group (n=25). In the low-flux group, dialyzer had an ultrafiltration coefficient 12 mL/(h·mmHg) and effective surface area of 1.4 m2 compared with 59 mL/(h·mmHg) and 1.8 m2 in the high-flux group. After treatment, the calcification of blood vessels was examined by lateral X-ray, pelvic plain film and bilateral positive position. For patients in all groups, the concentrations of parathyroid hormone (PTH) and β 2-microglobulin (β 2-MG) in serum were measured by automatic chemiluminescence; levels of interleukin-6, C-reactive protein (CRP), and tumor necrosis factor alpha (TNF-α) were measured by ELISA before and after treatment; and the level of hepcidin was measured by ELISA. Before and 12 weeks after the treatment, the nutritional status of the patients was evaluated by modified quantitative subjective global assessment (MQSGA), hemoglobin (Hb) and red blood cell count (RBC). Complications in the three groups were recorded, including nausea, chest pain, hypotension, hypertension, pruritus, dry heat, muscle spasm, arrhythmia, and restless legs. RESULTS Vascular calcification in the joint group was better than the low-flux and high-flux groups (P<0.05). After treatment, the serum PTH and β 2-mg concentrations in the joint group were lower than those in the other two groups (P<0.05), and the levels of IL-6, CRP, TNF-α and hepcidin in the joint group were significantly lower than those before treatment (P<0.05). After treatment, the MQSGA scores in the joint group were lower than those in the low-flux and high-flux groups (P<0.05), and Hb and RBC were higher (P<0.05). CONCLUSIONS The combination of high-flux HD and levocarnitine in elderly patients on MHD can increase the clearance of medium and large molecular toxins, effectively correct malnutrition, alleviate microinflammation, delay the progress of vascular calcification, and is safe.",2021,"RESULTS Vascular calcification in the joint group was better than the low-flux and high-flux groups (P<0.05).","['elderly patients on maintenance hemodialysis', 'elderly patients on maintenance HD (MHD', '75 MHD elderly patients admitted to hospital between 1st September 2017 and 31st August 2019 were selected as the study subjects', 'elderly patients on MHD']","['levocarnitine', 'high-flux hemodialysis (HD) combined with levocarnitine', 'low-flux group (n=25), high-flux group (n=25) and joint group']","['concentrations of parathyroid hormone (PTH) and β 2-microglobulin (β 2-MG) in serum were measured by automatic chemiluminescence; levels of interleukin-6, C-reactive protein (CRP), and tumor necrosis factor alpha (TNF-α', 'serum PTH and β 2-mg concentrations', 'nausea, chest pain, hypotension, hypertension, pruritus, dry heat, muscle spasm, arrhythmia, and restless legs', 'Complications', 'MQSGA scores', 'levels of IL-6, CRP, TNF-α and hepcidin', 'modified quantitative subjective global assessment (MQSGA), hemoglobin (Hb) and red blood cell count (RBC', 'calcification of blood vessels', 'Vascular calcification', 'level of hepcidin', 'vascular calcification, microinflammation, hepcidin, and malnutrition']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0087163', 'cui_str': 'Levocarnitine'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0162524', 'cui_str': 'Chemiluminescence, Physical'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0428408', 'cui_str': 'Serum parathyroid hormone measurement'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0037763', 'cui_str': 'Spasm'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0451514', 'cui_str': 'Subjective global assessment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0342649', 'cui_str': 'Vascular calcification'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}]",75.0,0.00874409,"RESULTS Vascular calcification in the joint group was better than the low-flux and high-flux groups (P<0.05).","[{'ForeName': 'Xiang-Geng', 'Initials': 'XG', 'LastName': 'Chi', 'Affiliation': 'Department of Nephrology, The Affiliated Xiaolan Hospital of Southern Medical University, Zhongshan, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Ma', 'Affiliation': 'Department of Nephrology, Guangzhou Hospital of Integrated Chinese and Western Medicine, Guangzhou, China.'}, {'ForeName': 'Wen-Bin', 'Initials': 'WB', 'LastName': 'Zhang', 'Affiliation': 'Department of Nephrology, The Affiliated Xiaolan Hospital of Southern Medical University, Zhongshan, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Cai', 'Affiliation': 'Department of Nephrology, The Affiliated Xiaolan Hospital of Southern Medical University, Zhongshan, China.'}, {'ForeName': 'Yan-Zhuan', 'Initials': 'YZ', 'LastName': 'Chen', 'Affiliation': 'Department of Nephrology, The Affiliated Xiaolan Hospital of Southern Medical University, Zhongshan, China.'}, {'ForeName': 'De-Liang', 'Initials': 'DL', 'LastName': 'Ding', 'Affiliation': 'Department of Nephrology, The Affiliated Xiaolan Hospital of Southern Medical University, Zhongshan, China. DLDing066@126.com.'}]",Annals of palliative medicine,['10.21037/apm-21-66'] 3600,33849104,A randomized trial of psychological intervention on perioperative anxiety and depression of patients with severe blepharoptosis undergoing autologous fascia lata frontal muscle suspension.,"BACKGROUND Perioperative negative emotion of surgical patients has a greater impact on surgical efficacy and prognosis. The study aimed to analyze the effect of psychological intervention on perioperative anxiety and depression of patients with severe blepharoptosis undergoing autologous fascia lata frontal muscle suspension, and provide a reference for improving and optimizing patient care plans. METHODS Ninety-two patients with severe blepharoptosis who underwent autologous fascia lata frontal muscle suspension in our hospital from February 2018 to January 2020 were selected as the research subjects. Patients were numbered according to the order of operation, and were divided into a control group (46 cases) and an observation group (46 cases) using a numerical random table method. Patients in both groups received routine nursing intervention during the perioperative period, and patients in the observation group also received psychological intervention during this period. The two groups of patients were evaluated using the Hamilton Anxiety Scale (HAM-A) and Hamilton Depression Scale (HAM-D). Numerical rating scale (NRS) results for surgical site pain were evaluated and compared between the groups. The perioperative compliance rate and nursing satisfaction rate of the two groups of patients were investigated and compared. Intraoperative and postoperative complications were collected, sorted, and compared between the two groups of patients. RESULTS (I) The HAM-A and HAM-D scores of the observation group before and after surgery were significantly lower than those of the control group (P<0.05). (II) The NRS scores of patients in the observation group were markedly lower than those in the control group at 6 h and 24 h postoperatively (P<0.05). (III) The intra- and post-operative complication rate of the observation group was lower than that of the control group (P<0.05). (IV) The compliance rate and the total satisfaction rate of patients with the perioperative care in the observation group was considerably higher compared to that of patients in the control group (P<0.05). CONCLUSIONS Our results showed that psychological intervention can effectively alleviate the negative emotions in patients with severe blepharoptosis who underwent autologous fascia lata frontal muscle suspension, improve their compliance with medical care, reduce their pain, and increase their satisfaction rate. Therefore, psychological intervention has high clinical value.",2021,The intra- and post-operative complication rate of the observation group was lower than that of the control group (P<0.05).,"['patients with severe blepharoptosis undergoing', 'patients with severe blepharoptosis undergoing autologous fascia lata frontal muscle suspension', 'Ninety-two patients with severe blepharoptosis who underwent', 'in our hospital from February 2018 to January 2020 were selected as the research subjects', 'patients with severe blepharoptosis who underwent']","['autologous fascia lata frontal muscle suspension', 'psychological intervention', 'routine nursing intervention']","['compliance rate and the total satisfaction rate', 'Numerical rating scale (NRS) results for surgical site pain', 'Intraoperative and postoperative complications', 'intra- and post-operative complication rate', 'perioperative compliance rate and nursing satisfaction rate', 'negative emotions', 'perioperative anxiety and depression', 'satisfaction rate', 'HAM-A and HAM-D scores', 'Hamilton Anxiety Scale (HAM-A) and Hamilton Depression Scale (HAM-D', 'NRS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005745', 'cui_str': 'Ptosis of eyelid'}, {'cui': 'C0440795', 'cui_str': 'Autologous fascia lata'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C0440795', 'cui_str': 'Autologous fascia lata'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332850', 'cui_str': 'Operative site'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",92.0,0.0187716,The intra- and post-operative complication rate of the observation group was lower than that of the control group (P<0.05).,"[{'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': 'Ophthalmology Operating Room, Second Affiliated Hospital Zhejiang University College of Medicine, Hangzhou, China.'}, {'ForeName': 'Suhui', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Ophthalmology Operating Room, Second Affiliated Hospital Zhejiang University College of Medicine, Hangzhou, China. 2195016@zju.edu.cn.'}]",Annals of palliative medicine,['10.21037/apm-21-345'] 3601,33849097,The effect of multi-dimensional postpartum visits on increasing the breastfeeding rate of parturients with inverted nipple: a randomised study.,"BACKGROUND Postpartum breastfeeding is an effective guarantee for the healthy growth of newborns. Vigorously promoting breastfeeding has substantial benefits for the physical and mental health of mothers and babies, and can also benefit the entire society. The purpose of this study was to explore the effect of multi-dimensional postpartum visits (MDPV) applied to parturients with inverted nipple on improving breastfeeding rates. METHODS A total of 114 parturients with inverted nipples who gave birth in the Drum Tower Hospital Affiliated to Nanjing University School of Medicine from October 2018 to October 2019 and successfully breastfed in the hospital were selected. The patients were divided into two groups according to the random number table method, with 57 cases in each group. The control group received routine postpartum visits, while the observation group received MDPV. Breastfeeding knowledge, rate of exclusive breastfeeding, incidence of maternal mastitis, rate of infant hospitalization, and level of self-efficacy were compared between the two groups. RESULTS Breastfeeding knowledge and the rate of exclusive breastfeeding at 1, 3, and 6 months after discharge in the observation group were higher than those in the control group (P<0.05). The incidence of maternal mastitis and the rate of infant hospitalization in the observation group were lower than those in the control group (P<0.05). The self-efficacy scores of the observation group at 1 and 6 months after discharge were higher than those of the control group (P<0.05). CONCLUSIONS The application of MDPV to parturients with inverted nipples can improve the breast-feeding rate, enhance breastfeeding knowledge, reduce the incidence of maternal mastitis and infant hospitalization rate, and improve breastfeeding self-efficacy. Thus, it is worthy of promotion.",2021,The incidence of maternal mastitis and the rate of infant hospitalization in the observation group were lower than those in the control group (P<0.05).,"['healthy growth of newborns', '114 parturients with inverted nipples who gave birth in the Drum Tower Hospital Affiliated to Nanjing University School of Medicine from October 2018 to October 2019 and successfully breastfed in the hospital were selected', 'parturients with inverted nipple on improving breastfeeding rates', 'parturients with inverted nipple']","['multi-dimensional postpartum visits (MDPV', 'routine postpartum visits, while the observation group received MDPV', 'multi-dimensional postpartum visits']","['breastfeeding self-efficacy', 'Breastfeeding knowledge, rate of exclusive breastfeeding, incidence of maternal mastitis, rate of infant hospitalization, and level of self-efficacy', 'breastfeeding rate', 'incidence of maternal mastitis and infant hospitalization rate', 'self-efficacy scores', 'rate of exclusive breastfeeding', 'incidence of maternal mastitis and the rate of infant hospitalization']","[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0269269', 'cui_str': 'Inversion of nipple'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0517671', 'cui_str': 'Knowledge level: breastfeeding'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0024894', 'cui_str': 'Mastitis'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",114.0,0.0267604,The incidence of maternal mastitis and the rate of infant hospitalization in the observation group were lower than those in the control group (P<0.05).,"[{'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': 'Obstetrics Department, Drum Tower Hospital Affiliated to Nanjing University School of Medicine, Nanjing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Obstetrics Department, Drum Tower Hospital Affiliated to Nanjing University School of Medicine, Nanjing, China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Bao', 'Affiliation': 'Obstetrics Department, Drum Tower Hospital Affiliated to Nanjing University School of Medicine, Nanjing, China. 331627342@qq.com.'}]",Annals of palliative medicine,['10.21037/apm-21-165'] 3602,33849093,Effect of peer support on improving self-management ability in peritoneal dialysis patients-a randomized controlled trial.,"BACKGROUND Peritoneal dialysis (PD) is an ideal method for the treatment of chronic kidney disease. Its survival rate and quality of life depend on the quality of dialysis. The quality of dialysis depends on the compliance of patients with drugs and dialysis treatment, the choice of diet, the detection of complications and the monitoring and management of the disease. Therefore, the self-management of PD patients is particularly important. This study explored the role of peer support in improving the self-management ability of PD patients. METHODS A total of 105 PD patients in a Chinese tertiary hospital were enrolled and divided into a control group (35 cases), a WeChat group (intervention group 1; 35 cases), and a face-to-face group (intervention group 2; 35 cases). During the 6-month follow-up, the control group were given individualized education, and the intervention group was given peer support. RESULTS After the 6-month intervention, the self-management ability of the intervention group was significantly different from that of the control group (P<0.01). There were significant differences between the WeChat group and the face-to-face group with respect to hemoglobin and blood phosphorus (P<0.05). There were significant differences in prealbumin, hemoglobin, blood phosphorus and calcium levels between the intervention and control groups after 3 months and 6 months of intervention (P<0.01). CONCLUSIONS Peer support can effectively improve the self-management ability and biochemical indicators in PD patients.",2021,"There were significant differences in prealbumin, hemoglobin, blood phosphorus and calcium levels between the intervention and control groups after 3 months and 6 months of intervention (P<0.01). ","['105 PD patients in a Chinese tertiary hospital', 'peritoneal dialysis patients', 'PD patients']","['individualized education, and the intervention group was given peer support', 'Peritoneal dialysis (PD', 'peer support', 'WeChat group (intervention']","['prealbumin, hemoglobin, blood phosphorus and calcium levels', 'quality of dialysis', 'survival rate and quality of life', 'self-management ability']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}]","[{'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0201925', 'cui_str': 'Calcium measurement'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",105.0,0.00436619,"There were significant differences in prealbumin, hemoglobin, blood phosphorus and calcium levels between the intervention and control groups after 3 months and 6 months of intervention (P<0.01). ","[{'ForeName': 'Xiaolei', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Department of Nephrology, Wuxi People's Hospital, Wuxi, China.""}, {'ForeName': 'Linghong', 'Initials': 'L', 'LastName': 'Hua', 'Affiliation': ""Department of Nephrology, Wuxi People's Hospital, Wuxi, China.""}, {'ForeName': 'Cen', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""Department of Nephrology, Wuxi People's Hospital, Wuxi, China.""}, {'ForeName': 'Zhenghong', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': ""Nursing Department of Wuxi People's Hospital, Wuxi, China.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': ""Nursing Department of Wuxi People's Hospital, Wuxi, China.""}, {'ForeName': 'Yinghua', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': ""Nursing Department of Wuxi People's Hospital, Wuxi, China. 179098331@qq.com.""}]",Annals of palliative medicine,['10.21037/apm-21-219'] 3603,33849091,The effectiveness of EVOSKIN®Palm and sole moisturizing cream in treating capecitabine-associated hand-foot syndrome: a randomized double-blind clinical trial.,"BACKGROUND This study sought to test the effectiveness of EVOSKIN®Palm and sole moisturizing cream (PSMC) in preventing and treating hand-foot syndrome (HFS) during capecitabine chemotherapy. METHODS Stage II/III colorectal cancer patients receiving capecitabine adjuvant chemotherapy were randomly allocated to receive either EVOSKINPSMC or physiological saline treatments for their hands and feet. Treatment was initiated along with adjuvant chemotherapy and continued till the end of chemotherapy. Participants' skin responses were evaluated every 3 weeks. RESULTS During the study, 51 participants in the EVOSKIN PSMC group and 54 participants in the physiological saline group completed at least three cycles of capecitabine chemotherapy. The total incidence of HFS in the EVOSKIN PSMC group was lower than that in the physiological saline group (56.8% vs. 75.9%, P=0.006), as was the incidence of Grade 3/4 HFS (6.0% vs. 18.5%, P=0.011). The incidence of HFS became significant after 6weeks of chemotherapy. Further, the incidence of severe HFS was significant from as early as 3weeks after the commencement of chemotherapy despite the use of EVOSKIN PSMC to manage the condition. Notably, the incidence of Grade 1/2 HFS was not statistically significant between the two groups (26/51 vs. 32/54, 52.0% vs. 59.2%, P=0.194). CONCLUSIONS The incidence of severe HFS among individuals using oral capecitabine can be reduced by the prophylactic treatment of EVOSKIN PSMC, this treatment is reasonable and acceptable for patients with capecitabine chemotherapy.",2021,"The total incidence of HFS in the EVOSKIN PSMC group was lower than that in the physiological saline group (56.8% vs. 75.9%, P=0.006), as was the incidence of Grade 3/4 HFS (6.0% vs. 18.5%, P=0.011).","['patients with capecitabine chemotherapy', 'Stage II/III colorectal cancer patients receiving', 'treating capecitabine-associated hand-foot syndrome', '51 participants in the EVOSKIN PSMC group and 54 participants in the']","['®Palm and sole moisturizing cream', '®Palm and sole moisturizing cream (PSMC', 'capecitabine chemotherapy', 'capecitabine', 'EVOSKINPSMC or physiological saline', 'capecitabine adjuvant chemotherapy', 'physiological saline']","['skin responses', 'incidence of Grade 1/2 HFS', 'incidence of Grade 3/4 HFS', 'severe HFS', 'total incidence of HFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0230373', 'cui_str': 'Palm of hand (surface region)'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0312646', 'cui_str': 'Finding related to response to skin test'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",51.0,0.152737,"The total incidence of HFS in the EVOSKIN PSMC group was lower than that in the physiological saline group (56.8% vs. 75.9%, P=0.006), as was the incidence of Grade 3/4 HFS (6.0% vs. 18.5%, P=0.011).","[{'ForeName': 'Weiqun', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'Department of Gastrointestinal Surgical Oncology, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Zhiliang', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Gastrointestinal Surgical Oncology, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Shicai', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Gastrointestinal Surgical Oncology, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Huizeng', 'Initials': 'H', 'LastName': 'Lv', 'Affiliation': 'Department of General Surgery, the Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Xinqi', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of General Surgery, the Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Lei', 'Affiliation': 'Department of General Surgery, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Chuanfeng', 'Initials': 'C', 'LastName': 'Ke', 'Affiliation': 'Department of General Surgery, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Chuyuan', 'Initials': 'C', 'LastName': 'Hong', 'Affiliation': 'Department of General Surgery, the Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Yisheng', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Department of General Surgery, the Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Su', 'Affiliation': 'Department of General Surgery, the Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of General Surgery, the Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of General Surgery, the First Municipal Hospital of Guangzhou, Guangzhou, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Yang', 'Affiliation': 'Department of General Surgery, the First Municipal Hospital of Guangzhou, Guangzhou, China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Tan', 'Affiliation': 'Department of Pathology, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Haiying', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Gastrointestinal Surgical Oncology, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, China. gzdlhy@sina.com.'}]",Annals of palliative medicine,['10.21037/apm-21-61'] 3604,33849087,Effect of Aqua Therapy Exercises on Postmastectomy Lymphedema: A Prospective Randomized Controlled Trial.,"Objective To investigate the effect of aqua therapy resistance exercise on arm volume, pain, and shoulder range of movements in post-mastectomy lymphedema. Methods This was a single-blind randomized controlled trial. Fifty eligible breast cancer survivors (median, 10 years after surgery) with lymphedema (median, 21% inter-limb difference) were assigned randomly to group A (n=25) or control group B (n=25). The study group underwent 60 minutes of aqua therapy exercise comprising of warm-up for 10 minutes, 40 minutes of strengthening exercises, and 10 minutes of cooling down, three times a week for 8 weeks. The control group underwent 60 minutes of land-based exercise three times a week for 8 weeks. Arm volume calculated by measuring the arm circumference, shoulder flexion, and abduction range of motion (ROM), and pain using a visual analog scale (VAS) were assessed at baseline and after 8 weeks of treatment. Results There was a statistically significant difference in limb volume, shoulder flexion and abduction ROM, and VAS scores in favor of the study group (p<0.001) after 8 weeks of intervention. The mean±standard deviation for limb volume, shoulder flexion, abduction, and pain score were 2,108.71±200.97 mL, 169.68°±4.54°, 150.44°±3.92°, and 3.16±1.1 in the study group and 2,256.41±186.94 mL, 147.36°±5.32°, 131.32°±4.38°, and 5.68±0.94 in the control group, respectively. Conclusion Adding aqua therapy resistance exercise to routine physical therapy might be more effective in decreasing the limb volume and pain intensity and improving ROM of the shoulder in postmastectomy lymphedema.",2021,"There was a statistically significant difference in limb volume, shoulder flexion and abduction ROM, and VAS scores in favor of the study group (p<0.001) after 8 weeks of intervention.","['Fifty eligible breast cancer survivors (median, 10 years after surgery) with lymphedema (median, 21% inter-limb difference', 'Postmastectomy Lymphedema']","['aqua therapy exercise comprising of warm-up for 10 minutes, 40 minutes of strengthening exercises', 'aqua therapy resistance exercise', 'Aqua Therapy Exercises']","['arm volume, pain, and shoulder range of movements', 'arm circumference, shoulder flexion, and abduction range of motion (ROM), and pain using a visual analog scale (VAS', 'limb volume, shoulder flexion and abduction ROM, and VAS scores', 'limb volume and pain intensity and improving ROM', 'mean±standard deviation for limb volume, shoulder flexion, abduction, and pain score']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0032775', 'cui_str': 'Post-mastectomy Lymphedema'}]","[{'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",50.0,0.0321675,"There was a statistically significant difference in limb volume, shoulder flexion and abduction ROM, and VAS scores in favor of the study group (p<0.001) after 8 weeks of intervention.","[{'ForeName': 'Khadra Mohamed', 'Initials': 'KM', 'LastName': 'Ali', 'Affiliation': 'Department of Physical Therapy for Surgery, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Eid Rizk', 'Initials': 'ER', 'LastName': 'El Gammal', 'Affiliation': 'Department of Oncosurgery, Faculty of Medicine, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Hadaya Mosaad', 'Initials': 'HM', 'LastName': 'Eladl', 'Affiliation': 'Department of Physical Therapy for Surgery, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}]",Annals of rehabilitation medicine,['10.5535/arm.20127'] 3605,33849040,Hypercapnia in COPD Patients Undergoing Endobronchial Ultrasound under Local Anaesthesia and Analgosedation: A Prospective Controlled Study Using Continuous Transcutaneous Capnometry.,"BACKGROUND Flexible bronchoscopy (FB) in analgosedation causes alveolar hypoventilation and hypercapnia, the more so if patients suffer from COPD. Nonetheless, neither is capnometry part of standard monitoring nor is there evidence on how long patients should be monitored after sedation. OBJECTIVES We investigated the impact of COPD on hypercapnia during FB with endobronchial ultrasound (EBUS) in sedation and how the periprocedural monitoring should be adapted. METHODS Two cohorts of consecutive patients - with advanced and without COPD - with the indication for FB with EBUS-guided transbronchial needle aspiration in analgosedation received continuous transcutaneous capnometry (ptcCO2) before, during, and for 60 min after the sedation with midazolam and alfentanil. MAIN RESULTS Forty-six patients with advanced COPD and 44 without COPD were included. The mean examination time was 26 ± 9 min. Patients with advanced COPD had a higher peak ptcCO2 (53.7 ± 7.1 vs. 46.8 ± 4.8 mm Hg, p < 0.001) and mean ptcCO2 (49.5 ± 6.8 vs. 44.0 ± 4.4 mm Hg, p < 0.001). Thirty-six percent of all patients reached the maximum hypercapnia after FB in the recovery room (8 ± 11 min). Patients with COPD needed more time to recover to normocapnia (22 ± 24 vs. 7 ± 11 min, p < 0.001). They needed a nasopharyngeal tube more often (28 vs. 11%, p < 0.001). All patients recovered from hypercapnia within 60 min after FB. No intermittent ventilation manoeuvres were needed. CONCLUSION A relevant proportion of patients reached their peak-pCO2 after the end of intervention. We recommend using capnometry at least for patients with known COPD. Flexible EBUS in analgosedation can be safely performed in patients with advanced COPD. For patients with advanced COPD, a postprocedural observation time of 60 min was sufficient.",2021,"They needed a nasopharyngeal tube more often (28 vs. 11%, p < 0.001).","['Two cohorts of consecutive patients - with advanced and without COPD - with the indication for FB with EBUS-guided', 'patients with known COPD', 'patients with advanced COPD', 'patients suffer from COPD', 'Forty-six patients with advanced COPD and 44 without COPD were included', 'COPD Patients Undergoing Endobronchial Ultrasound under Local Anaesthesia and Analgosedation']","['transbronchial needle aspiration in analgosedation received continuous transcutaneous capnometry (ptcCO2', 'Flexible bronchoscopy (FB', 'Hypercapnia', 'Continuous Transcutaneous Capnometry', 'midazolam and alfentanil', 'endobronchial ultrasound (EBUS']","['mean examination time', 'postprocedural observation time', 'maximum hypercapnia', 'time to recover to normocapnia', 'higher peak ptcCO2']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}, {'cui': 'C3160856', 'cui_str': 'Endobronchial ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}]","[{'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}, {'cui': 'C0181959', 'cui_str': 'Aspiration needle'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040653', 'cui_str': 'Measurement of transcutaneous partial pressure of carbon dioxide'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0002026', 'cui_str': 'Alfentanil'}, {'cui': 'C3160856', 'cui_str': 'Endobronchial ultrasound'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0444505', 'cui_str': 'Peak'}]",46.0,0.0835492,"They needed a nasopharyngeal tube more often (28 vs. 11%, p < 0.001).","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Galetin', 'Affiliation': 'Department of Thoracic Surgery, Faculty of Health, University Witten/Herdecke, Witten, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Strohleit', 'Affiliation': 'Department of Thoracic Surgery, Faculty of Health, University Witten/Herdecke, Witten, Germany.'}, {'ForeName': 'Friederike Sophie', 'Initials': 'FS', 'LastName': 'Magnet', 'Affiliation': 'Department of Pulmology, Faculty of Health, University Witten/Herdecke, Witten, Germany.'}, {'ForeName': 'Jost', 'Initials': 'J', 'LastName': 'Schnell', 'Affiliation': 'Department of Thoracic Surgery, Lung-Clinic Cologne-Merheim, Merheim, Germany.'}, {'ForeName': 'Aris', 'Initials': 'A', 'LastName': 'Koryllos', 'Affiliation': 'Department of Thoracic Surgery, Faculty of Health, University Witten/Herdecke, Witten, Germany.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Stoelben', 'Affiliation': 'Department of Thoracic Surgery, Faculty of Health, University Witten/Herdecke, Witten, Germany.'}]",Respiration; international review of thoracic diseases,['10.1159/000515920'] 3606,33849035,Age-Stratified Outcome in Treatment of Left Main Coronary Artery Stenosis: A NOBLE Trial Substudy.,"BACKGROUND In the treatment of left main coronary artery (LMCA) disease, patients' age may affect the clinical outcome after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). This study stratified the clinical outcome according to the age of patients treated for LMCA stenosis with PCI or CABG in the Nordic-Baltic-British Left Main Revascularization (NOBLE) study. METHODS Patients with LMCA disease were enrolled in 36 centers in northern Europe and randomized 1:1 to treatment by PCI or CABG. Eligible patients had stable angina pectoris, unstable angina pectoris, or non-ST elevation myocardial infarction. The primary endpoint was major adverse cardiac or cerebrovascular events (MACCEs), a composite of all-cause mortality, nonprocedural myocardial infarction, any repeat coronary revascularization, and stroke. Age-stratified analysis was performed for the groups younger and older than 67 years and for patients older than 80 years. RESULTS For patients ≥67 years, the 5-year MACCEs were 35.7 versus 22.3% (hazard ratio [HR] 1.72 [95% confidence interval [CI] 1.27-2.33], p = 0.0004) for PCI versus CABG. The difference in MACCEs was driven by more myocardial infarctions (10.8 vs. 3.8% HR 3.01 [95% CI 1.52-5.96], p = 0.0009) and more repeat revascularizations (19.5 vs. 10.0% HR 2.01 [95% CI 1.29-3.12], p = 0.002). In patients younger than 67 years, MACCE was 20.5 versus 15.3% (HR 1.38 [95% CI 0.93-2.06], p = 0.11 for PCI versus CABG. All-cause mortality was similar after PCI and CABG in both age-groups. On multivariate analysis, age was a predictor of MACCE, along with PCI, diabetes, and SYNTAX score. CONCLUSIONS As the overall NOBLE results show revascularization of LMCA disease, age of 67 years or older was associated with lower 5-year MACCE after CABG compared to PCI. Clinical outcomes were not significantly different in the subgroup younger than 67 years, although no significant interaction was present between age and treatment. Mortality was similar for all subgroups (ClinicalTrials.gov identifier: NCT01496651).",2021,"In patients younger than 67 years, MACCE was 20.5 versus 15.3% (HR 1.38 [95% CI 0.93-2.06], p = 0.11 for PCI versus CABG.","['patients treated for LMCA stenosis with PCI or CABG in the Nordic-Baltic-British Left Main Revascularization (NOBLE) study', 'Left Main Coronary Artery Stenosis', 'Patients with LMCA disease were enrolled in 36 centers in northern Europe', 'Eligible patients had stable angina pectoris, unstable angina pectoris, or non-ST elevation myocardial infarction', 'groups younger and older than 67 years and for patients older than 80 years']","['PCI or CABG', 'percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG']","['myocardial infarctions', 'Mortality', 'repeat revascularizations', '5-year MACCE', 'major adverse cardiac or cerebrovascular events (MACCEs), a composite of all-cause mortality, nonprocedural myocardial infarction, any repeat coronary revascularization, and stroke', '5-year MACCEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0242231', 'cui_str': 'Coronary artery stenosis'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0004715', 'cui_str': 'Baltic States'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0028413', 'cui_str': 'Northern Europe'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C1276061', 'cui_str': 'Acute non-ST segment elevation myocardial infarction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",,0.162051,"In patients younger than 67 years, MACCE was 20.5 versus 15.3% (HR 1.38 [95% CI 0.93-2.06], p = 0.11 for PCI versus CABG.","[{'ForeName': 'Terje', 'Initials': 'T', 'LastName': 'Steigen', 'Affiliation': 'Cardiovascular Research Group, UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Niels Ramsing', 'Initials': 'NR', 'LastName': 'Holm', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.'}, {'ForeName': 'Truls', 'Initials': 'T', 'LastName': 'Myrmel', 'Affiliation': 'Cardiovascular Research Group, UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Petter C', 'Initials': 'PC', 'LastName': 'Endresen', 'Affiliation': 'Department of Cardiovascular Surgery, University of Northern Norway, Tromsø, Norway.'}, {'ForeName': 'Thor', 'Initials': 'T', 'LastName': 'Trovik', 'Affiliation': 'Department of Cardiology, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Mäkikallio', 'Affiliation': 'Department of Cardiology, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Lindsay', 'Affiliation': 'Department of Cardiology, Golden Jubilee National Hospital, Clydebank, United Kingdom.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Spence', 'Affiliation': 'Belfast Heart Centre, Belfast Trust, Belfast, United Kingdom.'}, {'ForeName': 'Andrejs', 'Initials': 'A', 'LastName': 'Erglis', 'Affiliation': 'Latvia Centre of Cardiology, Paul Stradins Clinical Hospital, Riga, Latvia.'}, {'ForeName': 'Ian B A', 'Initials': 'IBA', 'LastName': 'Menown', 'Affiliation': 'Craigavon Cardiac Centre, Craigavon, United Kingdom.'}, {'ForeName': 'Indulis', 'Initials': 'I', 'LastName': 'Kumsars', 'Affiliation': 'Latvia Centre of Cardiology, Paul Stradins Clinical Hospital, Riga, Latvia.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kellerth', 'Affiliation': 'Department of Cardiology, Örebro University Hospital, Örebro, Sweden.'}, {'ForeName': 'Giedrius', 'Initials': 'G', 'LastName': 'Davidavičius', 'Affiliation': 'Department of Cardiology, Vilnius University Hospital, Vilnius, Lithuania.'}, {'ForeName': 'Rikard', 'Initials': 'R', 'LastName': 'Linder', 'Affiliation': 'Department of Cardiology, Danderyd Hospital, Stockholm, Sweden.'}, {'ForeName': 'Vesa', 'Initials': 'V', 'LastName': 'Anttila', 'Affiliation': 'Department of Cardiac Surgery, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Juul Hune Mogensen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Hostrup Nielsen', 'Affiliation': 'Department of Cardiac Surgery, Aarhus University Hospital, Skejby, Aarhus, Denmark.'}, {'ForeName': 'Alastair N J', 'Initials': 'ANJ', 'LastName': 'Graham', 'Affiliation': 'Belfast Heart Centre, Belfast Trust, Belfast, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hildick-Smith', 'Affiliation': 'Sussex Cardiac Centre, Brighton and Sussex University Hospital, Brighton, United Kingdom.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Thuesen', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Evald Høj', 'Initials': 'EH', 'LastName': 'Christiansen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cardiology,['10.1159/000515376'] 3607,33848906,Constraint Induced Movement Therapy Increases Functionality and Quality of Life after Stroke.,"This blind randomized clinical trial evaluated the effect of CIMT on the functionality and quality of life (QOL) of chronic hemiparetics. Thirty volunteers were divided into two groups: Control (CG) and CIMT (CIMTG); evaluated before and after 12 and 24 intervention sessions. The scales used were: adapted Fugl-Meyer Motor Assessment (FMA), Modified Ashworth, Stroke Specific Quality Of Life (SS-QOL) and the Functional Reach Test (FRT). The scores for all FMA variables in the CIMTG increased until the 24th session, differing from the pre-treatment. In the CG, the scores increased for pain, coordination/ speed and sensitivity. In the FRT there was an increase in the scores in both groups; after the 12th and 24th sessions, the result of the CIMTG was superior to the CG. For the SS-QOL in the CIMTG, the general score and most of the variables increased, as well as in the CG. Muscle tone in CIMTG was lower compared to CG after 24 sessions. Both protocols used in the study were effective, the CIMT protocol showed benefits in recovering the functionality of the paretic upper limb, in the functional range and in reducing muscle tone, with a consequent improvement in quality of life.",2021,"In the FRT there was an increase in the scores in both groups; after the 12th and 24th sessions, the result of the CIMTG was superior to the CG.",['Thirty volunteers'],"['CIMT', 'Control (CG) and CIMT (CIMTG']","['Muscle tone in CIMTG', 'quality of life', 'Functionality and Quality of Life', 'adapted Fugl-Meyer Motor Assessment (FMA), Modified Ashworth, Stroke Specific Quality Of Life', 'pain, coordination/ speed and sensitivity', 'functionality and quality of life (QOL) of chronic hemiparetics']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026841', 'cui_str': 'Muscle Tension'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]",30.0,0.0106232,"In the FRT there was an increase in the scores in both groups; after the 12th and 24th sessions, the result of the CIMTG was superior to the CG.","[{'ForeName': 'Larissa Salgado Oliveira', 'Initials': 'LSO', 'LastName': 'Rocha', 'Affiliation': 'Physiotherapy Course at the State University of Pará; Belém, Brazil; Postgraduate in Human Movement Sciences at the Methodist University of Piracicaba; Piracicaba, Brazil. Electronic address: lari1980@gmail.com.'}, {'ForeName': 'Geisa Crissy Bandeira', 'Initials': 'GCB', 'LastName': 'Gama', 'Affiliation': 'Physiotherapy Course at the State University of Pará; Belém, Brazil.'}, {'ForeName': 'Rodrigo Santiago Barbosa', 'Initials': 'RSB', 'LastName': 'Rocha', 'Affiliation': 'Physiotherapy Course at the State University of Pará; Belém, Brazil; Postgraduate in Human Movement Sciences at the Methodist University of Piracicaba; Piracicaba, Brazil.'}, {'ForeName': 'Letícia de Barros', 'Initials': 'LB', 'LastName': 'Rocha', 'Affiliation': 'Physiotherapy Course at the State University of Pará; Belém, Brazil.'}, {'ForeName': 'Caroline Prudente', 'Initials': 'CP', 'LastName': 'Dias', 'Affiliation': 'Physiotherapy Course at the State University of Pará; Belém, Brazil.'}, {'ForeName': 'Luciane Lobato Sobral', 'Initials': 'LLS', 'LastName': 'Santos', 'Affiliation': 'Physiotherapy Course at the State University of Pará; Belém, Brazil; Postgraduate in Human Movement Sciences at the Methodist University of Piracicaba; Piracicaba, Brazil.'}, {'ForeName': 'Márcio Clementino de Souza', 'Initials': 'MCS', 'LastName': 'Santos', 'Affiliation': 'Physiotherapy Course at the State University of Pará; Belém, Brazil.'}, {'ForeName': 'Maria Imaculada de Lima', 'Initials': 'MIL', 'LastName': 'Montebelo', 'Affiliation': 'Postgraduate in Human Movement Sciences at the Methodist University of Piracicaba; Piracicaba, Brazil.'}, {'ForeName': 'Rosana Macher', 'Initials': 'RM', 'LastName': 'Teodori', 'Affiliation': 'Postgraduate in Human Movement Sciences at the Methodist University of Piracicaba; Piracicaba, Brazil.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2021.105774'] 3608,33848830,Single site versus conventional laparoscopic appendectomy: some pain for no gain?,"INTRODUCTION The optimal laparoscopic appendectomy approach is not clear, comparing single site laparoscopic appendectomy (SILA) to conventional 3-port appendectomy (CLA). We investigated outcomes in pediatric patients comparing SILA to CLA: length of operation, length of stay, time to resumption of regular diet, follow up, rehospitalization, and cost. METHODS Data was collected from children 1 to 18 years with appendectomy at Loma Linda University from 2018 to 2020, operated by two surgeons. Analysis utilized two-sample T, chi-squared, and Fisher's exact tests. RESULTS Of 173 patients, 77 underwent SILA and 96 had CLA. There was no gender, age, or race difference between groups. Mean WBC was 17.5 × 10 3 /mL in SILA group, compared to 15.3 × 10 3 /mL in CLA group (P = 0.004). Operative time was 47.0 SILA compared to 49.5 minutes CLA (P = 0.269). Of SILA cases, 55.8% were simple appendicitis, while 53.3% of the CLA cases were simple (P = 0.857). Regular diet was resumed after 1.7 days in the SILA group, 1.1 days in CLA (P = 0.018). Length of stay was 2.9 days for SILA, 2.4 days for CLA (P = 0.144). Seven children required hospital readmission, 5 SILA and 2 CLA (P = 0.244). Five of the children who returned had intra-abdominal abscesses, of whom 4 had SILA. There was no difference in cost. CONCLUSIONS The operative techniques had similar outcomes and operative times. There was a trend toward more intra-abdominal abscesses in the SILA group. Further study and longer follow up is needed to determine if there is an advantage to one laparoscopic approach over another.",2021,"Length of stay was 2.9 days for SILA, 2.4 days for CLA (P = 0.144).","['pediatric patients comparing SILA to CLA', 'Data was collected from children 1 to 18 years with appendectomy at Loma Linda University from 2018 to 2020, operated by two surgeons', 'Of 173 patients, 77 underwent SILA and 96 had CLA']","['laparoscopic appendectomy (SILA) to conventional 3-port appendectomy (CLA', 'conventional laparoscopic appendectomy']","['Mean WBC', 'Length of stay', 'simple appendicitis', 'Operative time', 'cost', 'intra-abdominal abscesses', 'hospital readmission', 'operation, length of stay, time to resumption of regular diet, follow up, rehospitalization, and cost']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0372525', 'cui_str': 'Laparoscopic appendectomy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1018105', 'cui_str': 'Loma'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}]","[{'cui': 'C0372525', 'cui_str': 'Laparoscopic appendectomy'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0243001', 'cui_str': 'Abdominal abscess'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",7.0,0.119205,"Length of stay was 2.9 days for SILA, 2.4 days for CLA (P = 0.144).","[{'ForeName': 'Laura F', 'Initials': 'LF', 'LastName': 'Goodman', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, Loma Linda University, Loma Linda, California.'}, {'ForeName': 'Ann C', 'Initials': 'AC', 'LastName': 'Lin', 'Affiliation': 'Department of Surgery, Loma Linda University, Loma Linda, California.'}, {'ForeName': 'Marla A', 'Initials': 'MA', 'LastName': 'Sacks', 'Affiliation': 'Department of Surgery, Loma Linda University, Loma Linda, California; Division of Pediatric Surgery, Department of Surgery, Loma Linda University, Loma Linda, California.'}, {'ForeName': 'Joyce J L H', 'Initials': 'JJLH', 'LastName': 'McRae', 'Affiliation': 'School of Medicine, Loma Linda University, Loma Linda, California.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Radulescu', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, Loma Linda University, Loma Linda, California; School of Medicine, Loma Linda University, Loma Linda, California.'}, {'ForeName': 'Faraz A', 'Initials': 'FA', 'LastName': 'Khan', 'Affiliation': 'Department of Surgery, Loma Linda University, Loma Linda, California; Division of Pediatric Surgery, Department of Surgery, Loma Linda University, Loma Linda, California; School of Medicine, Loma Linda University, Loma Linda, California. Electronic address: fakhan@llu.edu.'}]",The Journal of surgical research,['10.1016/j.jss.2021.03.010'] 3609,33848805,Efficacy and safety of Prostate stereotactic body radiotherapy for metastatic castration-resistant prostate cancer: A prospective cohort study.,"BACKGROUND The efficacy and safety of prostate SBRT in men with mCRPC is unknown. MATERIALS AND METHODS A prospective cohort study was conducted with 125 men diagnosed with mCRPC. All patients received ADT plus chemotherapy. Patients were randomly assigned to receive daily prostate SBRT (36-48 Gy in 6-8 fractions). Patients who did not receive SBRT served as controls. RESULTS The primary endpoints were PFS and OS. After 89 months of total follow-up, the median PFS was 13.8 months in the SBRT group (n = 61) and 12.0 months in the control group (n = 64) (HR, 0.87; 95% CI, 0.61-1.24; P = 0.249). The OS was 25.7 months in the SBRT group and 23.8 months in the control group (HR, 0.93; 95% CI, 0.65-1.33; P = 0.230). A non-significant increase in the PSA response rate (50.8% vs. 43.7%) and time to PSA progression (8.3 months vs. 7.0 months) was observed in the SBRT group compared to the control group; however, the time to symptomatic progression was significantly prolonged in the SBRT group (11.3 months) compared to the control group (8.5 months) (HR, 0.76; 95% CI, 0.53-1.08; P = 0.019). There was an 11.5% incidence of radiation cystitis and radiation rectitis in the SBRT group, and the degree and incidence of hormone-related and chemotherapy-related adverse events were similar between the two groups. CONCLUSION Adding prostate SBRT significantly prolonged the time to symptomatic progression and non-significantly prolonged PFS and OS among men with mCRPC compared to treatment with ADT plus chemotherapy alone.",2021,Adding prostate SBRT significantly prolonged the time to symptomatic progression and non-significantly prolonged PFS and OS among men with mCRPC compared to treatment with ADT plus chemotherapy alone.,"['metastatic castration-resistant prostate cancer', 'Patients who did not receive SBRT served as controls', 'men with mCRPC', '125 men diagnosed with mCRPC']","['daily prostate SBRT', 'SBRT', 'Prostate stereotactic body radiotherapy', 'ADT plus chemotherapy']","['time to PSA progression', 'PFS and OS', 'time to symptomatic progression', 'degree and incidence of hormone-related and chemotherapy-related adverse events', 'median PFS', 'Efficacy and safety', 'PSA response rate', 'radiation cystitis and radiation rectitis']","[{'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0156270', 'cui_str': 'Irradiation cystitis'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0033246', 'cui_str': 'Proctitis'}]",125.0,0.0510175,Adding prostate SBRT significantly prolonged the time to symptomatic progression and non-significantly prolonged PFS and OS among men with mCRPC compared to treatment with ADT plus chemotherapy alone.,"[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Urology Oncological Surgery, Chongqing University Cancer Hospital, Han Yu Road 181, 400030 Chongqing, China.'}, {'ForeName': 'JunYong', 'Initials': 'J', 'LastName': 'Dai', 'Affiliation': 'Department of Urology Oncological Surgery, Chongqing University Cancer Hospital, Han Yu Road 181, 400030 Chongqing, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Xian', 'Affiliation': 'Department of Urology Oncological Surgery, Chongqing University Cancer Hospital, Han Yu Road 181, 400030 Chongqing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Xiong', 'Affiliation': 'Department of psychology, Chongqing University Cancer Hospital, 400030 Chongqing, China.'}, {'ForeName': 'YanPing', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Urology Oncological Surgery, Chongqing University Cancer Hospital, Han Yu Road 181, 400030 Chongqing, China.'}, {'ForeName': 'XianLi', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'Department of Urology Oncological Surgery, Chongqing University Cancer Hospital, Han Yu Road 181, 400030 Chongqing, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Urology Oncological Surgery, Chongqing University Cancer Hospital, Han Yu Road 181, 400030 Chongqing, China.'}, {'ForeName': 'Yongzhong', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Radiation Therapy Center, Chongqing University Cancer Hospital, Han Yu Road 181, 400030 Chongqing, China. Electronic address: cqmdwyz@163.com.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Urology Oncological Surgery, Chongqing University Cancer Hospital, Han Yu Road 181, 400030 Chongqing, China. Electronic address: berzou@163.com.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Liu', 'Affiliation': 'Department of Urology Oncological Surgery, Chongqing University Cancer Hospital, Han Yu Road 181, 400030 Chongqing, China. Electronic address: 1054567372@qq.com.'}]",Cancer treatment and research communications,['10.1016/j.ctarc.2021.100368'] 3610,33848764,The surgical management of the cavity and bone defects in enchondroma cases: A prospective randomized trial.,"BACKGROUND We compared the curettage/bone grafting and the curettage/bone graft substitutes surgical techniques in their relation to functional outcomes, oncologic outcome (recurrence, malignant transformation), the rate of postsurgical complications, durations of surgery and of postsurgical immobilization for hand-localized cases of solitary and multiple enchondromas. METHODS The current prospective randomized trial analyzed 200 adult patients (2012-2017) with enchondroma who underwent surgical intervention. The cases were randomly divided into Group 1 (n = 100; F 56, M 44) for surgeries with curettage and autogenous bone grafting, and Group 2 (n = 100; F 55, M 45) for surgeries with curettage and bone graft substitutes. The placebo control Group 3 consisted of cases operated by curettage only (n = 56; F 31, M 25). The follow-up period was set at 30 months. RESULTS The duration of surgery was 51 ± 4 min in Group 1 and 27 ± 1 min in Group 2 (p = 0.008). In Group 1, the rate of recurrence was 6% against 1% in Group 2 (p = 0.005). No other statistically significant differences in postsurgical outcomes between three involved groups were noted. CONCLUSION In cases of enchondroma of the hand, postsurgical functional outcomes, the rate of postsurgical complications, the duration of immobilization, and the time to complete recovery are not influenced by the type of chosen grafting material. The implementation of HAp-collagen bone substitutes in granules instead of autogenous bone grafting reduces the duration of surgery. The implementation of autogenous bone grafting may increase the rate of tumor recurrence.",2021,"In Group 1, the rate of recurrence was 6% against 1% in Group 2 (p = 0.005).","['200 adult patients (2012-2017) with enchondroma who underwent surgical intervention', 'enchondroma cases']","['placebo', 'curettage/bone grafting and the curettage/bone graft substitutes surgical techniques', 'surgeries with curettage and autogenous bone grafting, and Group 2 (n\xa0=\xa0100; F 55, M 45) for surgeries with curettage and bone graft substitutes', 'autogenous bone grafting']","['rate of recurrence', 'rate of postsurgical complications, the duration of immobilization, and the time to complete recovery', 'rate of tumor recurrence', 'postsurgical outcomes', 'rate of postsurgical complications, durations of surgery and of postsurgical immobilization']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704356', 'cui_str': 'Enchondroma'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010468', 'cui_str': 'Curettage'}, {'cui': 'C0005976', 'cui_str': 'Bone graft'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0440800', 'cui_str': 'Autogenous bone graft'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0521158', 'cui_str': 'Recurrent tumor'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",200.0,0.0376228,"In Group 1, the rate of recurrence was 6% against 1% in Group 2 (p = 0.005).","[{'ForeName': 'Nigora Z', 'Initials': 'NZ', 'LastName': 'Nazarova', 'Affiliation': 'Department of Traumatology, Orthopedics, and Military Surgery, Tashkent Medical Academy, Uzbekistan.'}, {'ForeName': 'Gulrukh Sh', 'Initials': 'GS', 'LastName': 'Umarova', 'Affiliation': 'Republican Scientific and Practical Medical Center for Traumatology and Orthopedics, Tashkent, Uzbekistan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Vaiman', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Assaf Harofe Medical Center, Affiliated to Sackler Faculty of Medicine, Tel Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Saodat U', 'Initials': 'SU', 'LastName': 'Asilova', 'Affiliation': 'Department of Traumatology, Orthopedics, and Military Surgery, Tashkent Medical Academy, Uzbekistan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Abba', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Barzilai Medical Center, Ashkelon, Israel.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Foonberg', 'Affiliation': 'Science Research Department, Milken Community High School, Los Angeles, CA, USA; Science Research Department, Alexander Muss High School in Israel (AMHSI) Affiliated with Alexander Muss Institute for Israel Education (AMIIE), Hod HaSharon, Israel.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Shterenshis', 'Affiliation': 'Science Research Department, Alexander Muss High School in Israel (AMHSI) Affiliated with Alexander Muss Institute for Israel Education (AMIIE), Hod HaSharon, Israel. Electronic address: mshterenshis@amhsi.org.'}]",Surgical oncology,['10.1016/j.suronc.2021.101565'] 3611,33848758,Patterns and predictors of nicotine replacement therapy use among alcohol and other drug clients enrolled in a smoking cessation randomised controlled trial.,"INTRODUCTION Nicotine replacement therapy (NRT) use to support client smoking quit attempts is low and inconsistent at alcohol and other drug (AOD) treatment services. This study examined predictors of any NRT use and combination NRT use among AOD clients who were smokers. METHODS The study was part of a cluster-RCT of an organisational change intervention to introduce smoking cessation support as part of routine treatment in 32 AOD services. The intervention provided AOD services with free NRT and training. Service clients completed baseline (n = 896), 8-week (n = 471) and 6.5-month (n = 427) follow-up surveys. Mixed-model logistic regression examined whether baseline socio-demographic and smoking variables were associated with single and combination NRT use. RESULTS At 8-weeks follow-up 57% (n = 269/471), and at 6.5-months 33% (n = 143/427) of participants reported using at least one form of NRT. Odds of NRT use at 8-weeks follow-up were greater among participants from treatment vs control group (OR = 3.69, 95%CI 1.8-7.4; p < 0.001), higher vs lower nicotine dependence (OR = 1.74 95%CI 1.1-2.8; p = 0.024), or those motivated to quit (OR = 1.18 95%CI 1.0-1.4; p = 0.017). At 6.5-months, only the treatment arm remained significant. Combination NRT use at the 8-week follow-up was higher among those in treatment vs control group (OR = 2.75 95%CI 1.4-5.6; p = 0.005), or with higher vs lower nicotine dependence (OR = 2.12 95%CI 1.2-3.8; p = 0.014). No factors were associated with combination NRT use at 6.5-months. CONCLUSIONS An organisational change intervention that supplied AOD services with NRT training and products to provide to clients during treatment significantly increases client single form and combination NRT use in the short term.",2021,An organisational change intervention that supplied AOD services with NRT training and products to provide to clients during treatment significantly increases client single form and combination NRT use in the short term.,"['AOD clients who were smokers', '32 AOD services']","['nicotine replacement therapy', 'Nicotine replacement therapy (NRT', 'NRT use and combination NRT', 'NRT training']",['nicotine dependence'],"[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0028043', 'cui_str': 'Nicotine dependence'}]",,0.0779025,An organisational change intervention that supplied AOD services with NRT training and products to provide to clients during treatment significantly increases client single form and combination NRT use in the short term.,"[{'ForeName': 'Ashleigh', 'Initials': 'A', 'LastName': 'Guillaumier', 'Affiliation': 'The University of Newcastle, Callaghan, Australia. Electronic address: Ashleigh.Guillaumier@newcastle.edu.au.'}, {'ForeName': 'Eliza', 'Initials': 'E', 'LastName': 'Skelton', 'Affiliation': 'The University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Tzelepis', 'Affiliation': 'The University of Newcastle, Callaghan, Australia; Hunter Medical Research Institute, New Lambton Heights, Australia; Hunter New England Population Health, Wallsend, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': ""D'Este"", 'Affiliation': 'The University of Newcastle, Callaghan, Australia; Australian National University, Canberra, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Paul', 'Affiliation': 'The University of Newcastle, Callaghan, Australia; Hunter Medical Research Institute, New Lambton Heights, Australia.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Walsberger', 'Affiliation': 'Cancer Council NSW, Sydney, Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Kelly', 'Affiliation': 'The University of Wollongong, Illawarra Health and Medical Research Institute, School of Psychology, Northfields Avenue, Wollongong, Australia.'}, {'ForeName': 'Kerrin', 'Initials': 'K', 'LastName': 'Palazzi', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, Australia.'}, {'ForeName': 'Billie', 'Initials': 'B', 'LastName': 'Bonevski', 'Affiliation': 'The University of Newcastle, Callaghan, Australia.'}]",Addictive behaviors,['10.1016/j.addbeh.2021.106935'] 3612,33848675,A call to caution when hydroxychloroquine is given to elderly COVID-19 patients.,"INTRODUCTION Hydroxychloroquine use in COVID-19 patients was widespread and uncontrolled until recently. Patients vulnerable to severe COVID-19 are at risk for hydroxychloroquine interactions with comorbidities and co-medications contributing to detrimental, including fatal adverse treatment effects. METHODS This is a retrospective survey of health conditions and co-medications of COVID-19 patients who were pre-screened for enrolment into a randomized, double-blind, placebo-controlled hydroxychloroquine multicenter trial. RESULTS Our survey involved 305 patients (median age 71 (IQR: 59-81) years). The majority of patients (N = 279, 92%) considered for inclusion into the clinical trial were not eligible mainly due to safety concerns caused by health conditions or co-medications. Most common were QT prolonging drugs (N = 188, 62%) and hematologic/hemato-oncologic diseases (N = 39, 13%) which prohibited the administration of hydroxychloroquine in our clinical trial. Additionally, 165 (54%) patients had health conditions and 167 (55%) were on co-medications that did not prohibit hydroxychloroquine treatment but had a risk of adverse interactions with hydroxychloroquine. Most common were diabetes (N = 86, 28%), renal insufficiency (N = 69, 23%) and heart failure (N = 58, 19%). CONCLUSION The majority of hospitalized COVID-19 patients had health conditions or took co-medications precluding safe treatment with hydroxychloroquine. Therefore, especially in elderly, hydroxychloroquine should be administered with extreme caution and only in clinical trials.",2021,"Most common were diabetes (N = 86, 28%), renal insufficiency (N = 69, 23%) and heart failure (N = 58, 19%). ","['elderly COVID-19 patients', '305 patients (median age 71 (IQR: 59-81) years', 'COVID-19 patients who were pre-screened for enrolment']","['placebo-controlled hydroxychloroquine', 'Hydroxychloroquine', 'hydroxychloroquine']","['heart failure', 'renal insufficiency', 'health conditions']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",305.0,0.31667,"Most common were diabetes (N = 86, 28%), renal insufficiency (N = 69, 23%) and heart failure (N = 58, 19%). ","[{'ForeName': 'Julian J', 'Initials': 'JJ', 'LastName': 'Gabor', 'Affiliation': 'Institute of Tropical Medicine, Travel Medicine and Human Parasitology, University Hospital Tübingen, Wilhelmstraße 27, 72074 Tübingen, Germany; Zollernalb Hospital Balingen, Tübinger Straße 30, 72336 Balingen, Germany. Electronic address: Julian.Gabor@uni-tuebingen.de.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Kreidenweiss', 'Affiliation': 'Institute of Tropical Medicine, Travel Medicine and Human Parasitology, University Hospital Tübingen, Wilhelmstraße 27, 72074 Tübingen, Germany; German Center for Infection Research (DZIF), Germany. Electronic address: andrea.kreidenweiss@medizin.uni-tuebingen.de.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Weber', 'Affiliation': 'Institute of Tropical Medicine, Travel Medicine and Human Parasitology, University Hospital Tübingen, Wilhelmstraße 27, 72074 Tübingen, Germany. Electronic address: s.weber@uni-tuebingen.de.'}, {'ForeName': 'Moaaz', 'Initials': 'M', 'LastName': 'Salama', 'Affiliation': 'Zollernalb Hospital Balingen, Tübinger Straße 30, 72336 Balingen, Germany. Electronic address: dr.moaaz.salama@gmail.com.'}, {'ForeName': 'Mihaly', 'Initials': 'M', 'LastName': 'Sulyok', 'Affiliation': 'Institute of Tropical Medicine, Travel Medicine and Human Parasitology, University Hospital Tübingen, Wilhelmstraße 27, 72074 Tübingen, Germany; Zollernalb Hospital Balingen, Tübinger Straße 30, 72336 Balingen, Germany; Department of Pathology and Neuropathology, University Hospital Tübingen, Liebermeisterstraße 8, 72076 Tübingen, Germany. Electronic address: mihaly.sulyok@klinikum.uni-tuebingen.de.'}, {'ForeName': 'Zita', 'Initials': 'Z', 'LastName': 'Sulyok', 'Affiliation': 'Institute of Tropical Medicine, Travel Medicine and Human Parasitology, University Hospital Tübingen, Wilhelmstraße 27, 72074 Tübingen, Germany; Neonatology, University Hospital Tübingen, Calwerstr. 7, 72076 Tübingen, Germany. Electronic address: zita.sulyok@uni-tuebingen.de.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Koehne', 'Affiliation': 'Institute of Tropical Medicine, Travel Medicine and Human Parasitology, University Hospital Tübingen, Wilhelmstraße 27, 72074 Tübingen, Germany; Zollernalb Hospital Balingen, Tübinger Straße 30, 72336 Balingen, Germany. Electronic address: erik.koehne@uni-tuebingen.de.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Esen', 'Affiliation': 'Institute of Tropical Medicine, Travel Medicine and Human Parasitology, University Hospital Tübingen, Wilhelmstraße 27, 72074 Tübingen, Germany; German Center for Infection Research (DZIF), Germany. Electronic address: meral.esen@uni-tuebingen.de.'}, {'ForeName': 'Benno', 'Initials': 'B', 'LastName': 'Kreuels', 'Affiliation': 'Department of Tropical Medicine Bernhard Nocht Institute for Tropical Medicine & I. Dep. of Medicine, University Medical Center Hamburg-Eppendorf, Bernhard-Nocht-Straße 74, 20359 Hamburg, Germany. Electronic address: b.kreuels@uke.de.'}, {'ForeName': 'Parichehr', 'Initials': 'P', 'LastName': 'Shamsrizi', 'Affiliation': 'Department of Tropical Medicine Bernhard Nocht Institute for Tropical Medicine & I. Dep. of Medicine, University Medical Center Hamburg-Eppendorf, Bernhard-Nocht-Straße 74, 20359 Hamburg, Germany. Electronic address: p.shamsrizi@uke.de.'}, {'ForeName': 'Erwin', 'Initials': 'E', 'LastName': 'Biecker', 'Affiliation': 'Zollernalb Hospital Balingen, Tübinger Straße 30, 72336 Balingen, Germany. Electronic address: Erwin.Biecker@zollernalb-klinikum.de.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Mordmüller', 'Affiliation': 'Institute of Tropical Medicine, Travel Medicine and Human Parasitology, University Hospital Tübingen, Wilhelmstraße 27, 72074 Tübingen, Germany; Department of Medical Microbiology, Radboud University Medical Center, 6525 GA Nijmegen, The Netherlands. Electronic address: benjamin.mordmueller@uni-tuebingen.de.'}, {'ForeName': 'Christoph P', 'Initials': 'CP', 'LastName': 'Berg', 'Affiliation': 'Dept. of Internal Medicine I, University Hospital Tübingen, Otfried-Müller-Str. 10, 72076 Tübingen, Germany. Electronic address: christoph.berg@med.uni-tuebingen.de.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Fusco', 'Affiliation': 'Dept. of Internal Medicine I, University Hospital Tübingen, Otfried-Müller-Str. 10, 72076 Tübingen, Germany. Electronic address: Stefano.Fusco@med.uni-tuebingen.de.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Köhler', 'Affiliation': 'Institute of Tropical Medicine, Travel Medicine and Human Parasitology, University Hospital Tübingen, Wilhelmstraße 27, 72074 Tübingen, Germany; German Center for Infection Research (DZIF), Germany. Electronic address: carsten.koehler@medizin.uni-tuebingen.de.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kubicka', 'Affiliation': 'Hospital Steinenberg, Steinenbergstraße 31, 72764 Reutlingen, Germany. Electronic address: Kubicka_S@klin-rt.de.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Leitlein', 'Affiliation': 'Hospital Steinenberg, Steinenbergstraße 31, 72764 Reutlingen, Germany. Electronic address: leitlein_j@klin-rt.de.'}, {'ForeName': 'Marylyn', 'Initials': 'M', 'LastName': 'Addo', 'Affiliation': 'Department of Tropical Medicine Bernhard Nocht Institute for Tropical Medicine & I. Dep. of Medicine, University Medical Center Hamburg-Eppendorf, Bernhard-Nocht-Straße 74, 20359 Hamburg, Germany; German Center for Infection Research (DZIF), Germany. Electronic address: m.addo@uke.de.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ramharter', 'Affiliation': 'Centre de Recherches Médicale de Lambaréné (CERMEL), B.P: 242 Lambaréné, Gabon; Department of Tropical Medicine Bernhard Nocht Institute for Tropical Medicine & I. Dep. of Medicine, University Medical Center Hamburg-Eppendorf, Bernhard-Nocht-Straße 74, 20359 Hamburg, Germany; German Center for Infection Research (DZIF), Germany. Electronic address: ramharter@bnitm.de.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Schwab', 'Affiliation': 'Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology, Auerbachstr. 112, 70376 Stuttgart, Germany; Departments of Clinical Pharmacology, and of Pharmacy and Biochemistry, University Tübingen, Morgenstelle 8, 72076 Tübingen, Germany. Electronic address: Matthias.Schwab@ikp-stuttgart.de.'}, {'ForeName': 'Alfred Lennart', 'Initials': 'AL', 'LastName': 'Bissinger', 'Affiliation': 'Institute of Tropical Medicine, Travel Medicine and Human Parasitology, University Hospital Tübingen, Wilhelmstraße 27, 72074 Tübingen, Germany. Electronic address: Alfred.Bissinger@med.uni-tuebingen.de.'}, {'ForeName': 'Thirumalaisamy P', 'Initials': 'TP', 'LastName': 'Velavan', 'Affiliation': 'Institute of Tropical Medicine, Travel Medicine and Human Parasitology, University Hospital Tübingen, Wilhelmstraße 27, 72074 Tübingen, Germany; Vietnamese - German Centre for Medical Research (VG-CARE), Hanoi, Viet Nam. Electronic address: velavan@medizin.uni-tuebingen.de.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Krishna', 'Affiliation': 'Institute of Infection and Immunity, Cranmer Terrace, Tooting, London SW17 0RE, United Kingdom. Electronic address: sgjf100@sgul.ac.uk.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Kremsner', 'Affiliation': 'Institute of Tropical Medicine, Travel Medicine and Human Parasitology, University Hospital Tübingen, Wilhelmstraße 27, 72074 Tübingen, Germany; Centre de Recherches Médicale de Lambaréné (CERMEL), B.P: 242 Lambaréné, Gabon; German Center for Infection Research (DZIF), Germany. Electronic address: peter.kremsner@uni-tuebingen.de.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2021.04.009'] 3613,33848641,"Improving the transition of patients with mental health disorders back to primary care: A protocol for a partnered, mixed-methods, stepped-wedge implementation trial.","The current study protocol regards a partnered, mixed-methods, cluster-randomized stepped wedge trial of the implementation and effectiveness of the FLOW program. FLOW (not an acronym) is a collection of resources and strategies to assist in determining which recovered or stabilized specialty mental health (SMH) patients should transition back to primary care (PC) and tools to make the transition seamless. Transitioning appropriate patients to PC can increase access and timeliness of mental health care for newly referred mental health patients. Nine sites in one US region will be randomized to one of three waves in which they will receive implementation-facilitation to implement the FLOW program. Primary outcomes will include the reach of FLOW, provider adoption of the program, effectiveness in increasing access in SMH, implementation fidelity, and maintenance over time. A mixed-methods analysis of implementation factors associated with implementation success will also be conducted, including the following as possible predictors: staffing ratios, site resources, leadership and provider support for the program, and local champion characteristics. This study's results will provide evidence for the effectiveness of FLOW in increasing access and may provide generalizable information about characteristics of sites that are likely to be successful with implementing similar programs.",2021,Transitioning appropriate patients to PC can increase access and timeliness of mental health care for newly referred mental health patients.,"['patients with mental health disorders back to primary care', 'newly referred mental health patients']",[],"['reach of FLOW, provider adoption of the program, effectiveness in increasing access in SMH, implementation fidelity, and maintenance over time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",[],"[{'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0487379,Transitioning appropriate patients to PC can increase access and timeliness of mental health care for newly referred mental health patients.,"[{'ForeName': 'Natalie E', 'Initials': 'NE', 'LastName': 'Hundt', 'Affiliation': 'VA HSR&D Houston Center of Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey VA Medical Center, Houston, TX, United States; Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, United States; VA South Central Mental Illness Research, Education and Clinical Center, Houston, TX, United States. Electronic address: Natalie.Hundt@va.gov.'}, {'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Zenab', 'Affiliation': 'VA HSR&D Houston Center of Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey VA Medical Center, Houston, TX, United States.'}, {'ForeName': 'Amber B', 'Initials': 'AB', 'LastName': 'Amspoker', 'Affiliation': 'VA HSR&D Houston Center of Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey VA Medical Center, Houston, TX, United States; VA South Central Mental Illness Research, Education and Clinical Center, Houston, TX, United States.'}, {'ForeName': 'Nagamoto', 'Initials': 'N', 'LastName': 'Herbert', 'Affiliation': 'VA Rocky Mountain Network, Denver, CO, United States; University of Colorado School of Medicine, Denver, CO, United States.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Bo', 'Affiliation': 'HSR&D Center for Healthcare Organization and Implementation Research, VA Boston Healthcare System, Boston, MA 02130, United States; Department of Psychiatry, Harvard Medical School, Boston, MA 02115, United States.'}, {'ForeName': 'Derrecka M', 'Initials': 'DM', 'LastName': 'Boykin', 'Affiliation': 'VA HSR&D Houston Center of Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey VA Medical Center, Houston, TX, United States; Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, United States; VA South Central Mental Illness Research, Education and Clinical Center, Houston, TX, United States.'}, {'ForeName': 'Tracey L', 'Initials': 'TL', 'LastName': 'Smith', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106398'] 3614,33848604,"Botulinum toxin improves forehead scars after Mohs surgery: a randomized, double-blinded, controlled study.",,2021,,['forehead scars after Mohs surgery'],['Botulinum toxin'],[],"[{'cui': 'C0016540', 'cui_str': 'Forehead structure'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0079850', 'cui_str': 'Mohs surgery'}]","[{'cui': 'C0006055', 'cui_str': 'botulinum toxin'}]",[],,0.856501,,"[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Lin', 'Affiliation': 'Division of Dermatologic Surgery, Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: matthew.lin@mountsinai.org.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Bernstein', 'Affiliation': 'Division of Dermatologic Surgery, Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Torbeck', 'Affiliation': 'Division of Dermatologic Surgery, Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Danielle P', 'Initials': 'DP', 'LastName': 'Dubin', 'Affiliation': 'Division of Dermatologic Surgery, Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Rosenberg', 'Affiliation': 'Division of Facial Plastic Surgery, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Khorasani', 'Affiliation': 'Division of Dermatologic Surgery, Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2021.03.110'] 3615,33848565,Metabolic syndrome and the benefit of a physical activity intervention on lower-extremity function: Results from a randomized clinical trial.,"BACKGROUND In older adults, increases in physical activity may prevent decline in lower-extremity function, but whether the benefit differs according to metabolic syndrome (MetS) status is uncertain. We aim to investigate whether structured physical activity is associated with less decline in lower-extremity function among older adults with versus without MetS. METHODS We used data from the multicenter Lifestyle Interventions and Independence for Elders (LIFE) study to analyze 1535 sedentary functionally-vulnerable women and men, aged 70 to 89 years old, assessed every 6 months (February 2010-December 2013) for an average of 2.7 years. Participants were randomized to a structured, moderate-intensity physical activity intervention (PA; n = 766) or health education program (HE; n = 769). MetS was defined according to the 2009 multi-agency harmonized criteria. Lower-extremity function was assessed by 400-m walking speed and the Short Physical Performance Battery (SPPB) score. RESULTS 763 (49.7%) participants met criteria for MetS at baseline. Relative to HE, PA was associated with faster 400-m walking speed among participants with MetS (P < 0.001) but not among those without MetS (P = 0.91), although the test for statistical interaction was marginally non-significant (P = 0.07). In contrast, no benefit of PA versus HE was observed on the SPPB score in either MetS subgroup. CONCLUSIONS Among older adults at high risk for mobility disability, moderate-intensity physical activity conveys significant benefits in 400-m walking speed but not SPPB in those with, but not without, MetS. The LIFE physical activity program may be an effective strategy for maintaining or improving walking speed among vulnerable older adults with MetS. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01072500.",2021,"Relative to HE, PA was associated with faster 400-m walking speed among participants with MetS (P < 0.001) but not among those without MetS (P = 0.91), although the test for statistical interaction was marginally non-significant (P = 0.07).","['older adults', 'older adults with versus without MetS.\nMETHODS', '1535 sedentary functionally-vulnerable women and men, aged 70 to 89\u202fyears old, assessed every 6\u202fmonths (February 2010-December 2013) for an average of 2.7\u202fyears', 'vulnerable older adults with MetS.\nTRIAL REGISTRATION']","['physical activity intervention', 'moderate-intensity physical activity intervention (PA; n\u202f=\u202f766) or health education program (HE; n\u202f=\u202f769']","['Lower-extremity function', '400-m walking speed and the Short Physical Performance Battery (SPPB) score', 'SPPB score', 'Metabolic syndrome', 'lower-extremity function']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0585339', 'cui_str': 'Every six months'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4075289', 'cui_str': 'Short Physical Performance Battery score'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]",,0.0752883,"Relative to HE, PA was associated with faster 400-m walking speed among participants with MetS (P < 0.001) but not among those without MetS (P = 0.91), although the test for statistical interaction was marginally non-significant (P = 0.07).","[{'ForeName': 'Anda', 'Initials': 'A', 'LastName': 'Botoseneanu', 'Affiliation': 'Department of Health and Human Services and Institute of Gerontology, University of Michigan, Ann Arbor and Dearborn, MI, USA. Electronic address: andabm@umich.edu.'}, {'ForeName': 'Haiying', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Walter T', 'Initials': 'WT', 'LastName': 'Ambrosius', 'Affiliation': 'Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Heather G', 'Initials': 'HG', 'LastName': 'Allore', 'Affiliation': 'Department of Internal Medicine/Geriatrics, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Anton', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Sara C', 'Initials': 'SC', 'LastName': 'Folta', 'Affiliation': 'Friedman School of Nutrition Science and Policy, Tufts University, Boston, MA, USA.'}, {'ForeName': 'Abby C', 'Initials': 'AC', 'LastName': 'King', 'Affiliation': 'Department of Epidemiology & Population Health and the Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Nicklas', 'Affiliation': 'J. Paul Sticht Center on Aging, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Spring', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Elsa S', 'Initials': 'ES', 'LastName': 'Strotmeyer', 'Affiliation': 'Department of Epidemiology, Center for Aging and Population Health, Graduate School of Public Health, University of Pittsburgh, PA, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Gill', 'Affiliation': 'Department of Internal Medicine/Geriatrics, Yale School of Medicine, New Haven, CT, USA. Electronic address: thomas.gill@yale.edu.'}]",Experimental gerontology,['10.1016/j.exger.2021.111343'] 3616,33848462,"Copanlisib plus rituximab versus placebo plus rituximab in patients with relapsed indolent non-Hodgkin lymphoma (CHRONOS-3): a double-blind, randomised, placebo-controlled, phase 3 trial.","BACKGROUND Copanlisib, an intravenous pan-class I PI3K inhibitor, showed efficacy and safety as monotherapy in patients with relapsed or refractory indolent non-Hodgkin lymphoma who had received at least two therapies. The CHRONOS-3 study aimed to assess the efficacy and safety of copanlisib plus rituximab in patients with relapsed indolent non-Hodgkin lymphoma. METHODS CHRONOS-3 was a multicentre, double-blind, randomised, placebo-controlled, phase 3 study in 186 academic medical centres across Asia, Australia, Europe, New Zealand, North America, Russia, South Africa, and South America. Patients aged 18 years and older with an Eastern Cooperative Oncology Group performance status of no more than 2 and histologically confirmed CD20-positive indolent B-cell lymphoma relapsed after the last anti-CD20 monoclonal antibody-containing therapy and progression-free and treatment-free for at least 12 months, or at least 6 months for patients unwilling or unfit to receive chemotherapy, were randomly assigned (2:1) with an interactive voice-web response system via block randomisation (block size of six) to copanlisib (60 mg given as a 1-h intravenous infusion on an intermittent schedule on days 1, 8, and 15 [28-day cycle]) plus rituximab (375 mg/m 2 given intravenously weekly on days 1, 8, 15, and 22 during cycle 1 and day 1 of cycles 3, 5, 7, and 9) or placebo plus rituximab, stratified on the basis of histology, progression-free and treatment-free interval, presence of bulky disease, and previous treatment with PI3K inhibitors. The primary outcome was progression-free survival in the full analysis set (all randomised patients) by masked central review. Safety was assessed in all patients who received at least one dose of any study drug. This study is registered with ClinicalTrials.gov, NCT02367040 and is ongoing. FINDINGS Between Aug 3, 2015, and Dec 17, 2019, 652 patients were screened for eligibility. 307 of 458 patients were randomly assigned to copanlisib plus rituximab and 151 patients were randomly assigned to placebo plus rituximab. With a median follow-up of 19·2 months (IQR 7·4-28·8) and 205 total events, copanlisib plus rituximab showed a statistically and clinically significant improvement in progression-free survival versus placebo plus rituximab; median progression-free survival 21·5 months (95% CI 17·8-33·0) versus 13·8 months (10·2-17·5; hazard ratio 0·52 [95% CI 0·39-0·69]; p<0·0001). The most common grade 3-4 adverse events were hyperglycaemia (173 [56%] of 307 patients in the copanlisib plus rituximab group vs 12 [8%] of 146 in the placebo plus rituximab group) and hypertension (122 [40%] vs 13 [9%]). Serious treatment-emergent adverse events were reported in 145 (47%) of 307 patients receiving copanlisib plus rituximab and 27 (18%) of 146 patients receiving placebo plus rituximab. One (<1%) drug-related death (pneumonitis) occurred in the copanlisib plus rituximab group and none occurred in the placebo plus rituximab group. INTERPRETATION Copanlisib plus rituximab improved progression-free survival in patients with relapsed indolent non-Hodgkin lymphoma compared with placebo plus rituximab. To our knowledge, copanlisib is the first PI3K inhibitor to be safely combined with rituximab and the first to show broad and superior efficacy in combination with rituximab in patients with relapsed indolent non-Hodgkin lymphoma. FUNDING Bayer.",2021,"One (<1%) drug-related death (pneumonitis) occurred in the copanlisib plus rituximab group and none occurred in the placebo plus rituximab group. ","['307 patients receiving', 'Between Aug 3, 2015, and Dec 17, 2019, 652 patients were screened for eligibility', 'Patients aged 18 years and older with an Eastern Cooperative Oncology Group performance status of no more than 2 and histologically confirmed CD20-positive indolent B-cell lymphoma relapsed after the last anti-CD20 monoclonal antibody-containing therapy and progression-free and treatment-free for at least 12 months, or at least 6 months for patients unwilling or unfit to receive', 'patients with relapsed indolent non-Hodgkin lymphoma (CHRONOS-3', 'and 151 patients', '307 of 458 patients', 'patients with relapsed or refractory indolent non-Hodgkin lymphoma who had received at least two therapies', 'patients with relapsed indolent non-Hodgkin lymphoma', '186 academic medical centres across Asia, Australia, Europe, New Zealand, North America, Russia, South Africa, and South America']","['placebo plus rituximab', 'rituximab', 'PI3K inhibitors', 'copanlisib plus rituximab', 'placebo', 'chemotherapy', 'interactive voice-web response system via block randomisation (block size of six) to copanlisib', 'intravenous pan-class', 'Copanlisib plus rituximab']","['hypertension', 'efficacy and safety', 'drug-related death (pneumonitis', 'Safety', 'progression-free survival', 'hyperglycaemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C3888518', 'cui_str': 'CD20 antigen positive'}, {'cui': 'C0079731', 'cui_str': 'B-cell lymphoma (clinical)'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0796614', 'cui_str': 'ocaratuzumab'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0558080', 'cui_str': 'Unwilling'}, {'cui': 'C0024305', 'cui_str': 'Malignant lymphoma, non-Hodgkin'}, {'cui': 'C5191377', 'cui_str': '458'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0037713', 'cui_str': 'South America'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0044602', 'cui_str': '1-phosphatidylinositol 3-kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4049141', 'cui_str': 'copanlisib'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0030266', 'cui_str': 'Panama'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3714636', 'cui_str': 'Pneumonitis'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",652.0,0.649494,"One (<1%) drug-related death (pneumonitis) occurred in the copanlisib plus rituximab group and none occurred in the placebo plus rituximab group. ","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Matasar', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA. Electronic address: matasarm@mskcc.org.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Capra', 'Affiliation': 'Centro de Hematologia e Oncologia, Hospital Mãe de Deus, Porto Alegre, Brazil.'}, {'ForeName': 'Muhit', 'Initials': 'M', 'LastName': 'Özcan', 'Affiliation': 'Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Fangfang', 'Initials': 'F', 'LastName': 'Lv', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Yañez', 'Affiliation': 'Oncology-Hematology Unit, Department of Internal Medicine, School of Medicine, University of La Frontera, Temuco, Chile.'}, {'ForeName': 'Katya', 'Initials': 'K', 'LastName': 'Sapunarova', 'Affiliation': 'Medical University, Plovdiv, Bulgaria.'}, {'ForeName': 'Tongyu', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': 'Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'The First Affiliated Hospital of Zhejiang University College of Medicine, Hangzhou, China.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Jurczak', 'Affiliation': 'Maria Skłodowska-Curie National Research Institute of Oncology, Krakow, Poland.'}, {'ForeName': 'Aryan', 'Initials': 'A', 'LastName': 'Hamed', 'Affiliation': 'Petz Aladár Megyei Oktató Kórház, Győr, Hungary.'}, {'ForeName': 'Ming-Chung', 'Initials': 'MC', 'LastName': 'Wang', 'Affiliation': 'Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Baker', 'Affiliation': 'Hollywood Private Hospital, Nedlands, WA, Australia.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Bondarenko', 'Affiliation': 'Chemotherapy Department, City Dnipropetrovsk Multi-field Clinical Hospital, 4 DSMA, Dnipro, Ukraine.'}, {'ForeName': 'Qingyuan', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Jifeng', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Jiangsu Cancer Hospital, Nanjing, China.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Geissler', 'Affiliation': 'Sigmund Freud University, Vienna, Austria.'}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Lazaroiu', 'Affiliation': 'SC Policlinica de Diagnostic Rapid SA, Brasov, Romania.'}, {'ForeName': 'Guray', 'Initials': 'G', 'LastName': 'Saydam', 'Affiliation': 'Ege Üniversitesi Tıp Fakültesi, Izmir, Turkey.'}, {'ForeName': 'Árpád', 'Initials': 'Á', 'LastName': 'Szomor', 'Affiliation': 'Pécsi Tudományegyetem Klinikai Központ, Pécs, Hungary.'}, {'ForeName': 'Krimo', 'Initials': 'K', 'LastName': 'Bouabdallah', 'Affiliation': 'Hematology and Cellular Therapy Department, University Hospital of Bordeaux, Bordeaux, France.'}, {'ForeName': 'Rinat', 'Initials': 'R', 'LastName': 'Galiulin', 'Affiliation': 'Department of Chemotherapy for Children and Adults, Clinical Oncological Dispensary of Omsk Region, Omsk, Russian Federation.'}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Uchida', 'Affiliation': 'Hematology and Oncology, Japanese Red Cross Nagoya Daini Hospital, Nagoya, Japan.'}, {'ForeName': 'Lidia Mongay', 'Initials': 'LM', 'LastName': 'Soler', 'Affiliation': 'Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA.'}, {'ForeName': 'Anjun', 'Initials': 'A', 'LastName': 'Cao', 'Affiliation': 'Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Hiemeyer', 'Affiliation': 'Pharmaceuticals Division, Bayer, Berlin, Germany.'}, {'ForeName': 'Aruna', 'Initials': 'A', 'LastName': 'Mehra', 'Affiliation': 'Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA.'}, {'ForeName': 'Barrett H', 'Initials': 'BH', 'LastName': 'Childs', 'Affiliation': 'Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA.'}, {'ForeName': 'Yuankai', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Medical Oncology, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: syuankai@cicams.ac.cn.'}, {'ForeName': 'Pier Luigi', 'Initials': 'PL', 'LastName': 'Zinzani', 'Affiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia ""Seràgnoli"", and Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Università di Bologna, Bologna, Italy.'}]",The Lancet. Oncology,['10.1016/S1470-2045(21)00145-5'] 3617,33848441,Comparison of Vibrating Mesh and Jet Nebulizers During Noninvasive Ventilation in Acute Exacerbation of Chronic Obstructive Pulmonary Disease.,"Background: Advances in aerosol technology have improved drug delivery efficiency during noninvasive ventilation (NIV). Clinical evaluation of the efficacy of aerosol therapy during NIV in the treatment of acute exacerbation of chronic obstructive pulmonary disease (COPD) is very limited. The aim of our study was to compare the efficacy of bronchodilators administered through a vibrating mesh nebulizer (VMN) and jet nebulizer (JN) during NIV in patients with acute exacerbation of COPD. Methods: Prospective randomized cross-over study included 30 patients treated with NIV for acute exacerbation of COPD in an acute care hospital. Patients were consented and enrolled after stabilization of acute exacerbation (3-5 days after admission). Subjects were randomly assigned into two treatment arms receiving salbutamol (2.5 mg): with VMN (Aerogen Solo) and JN (Sidestream) positioned between the leak port and the nonvented oronasal mask during bilevel ventilation with a single-limb circuit. Measurements (clinical data, pulmonary function tests [PFTs], and arterial blood gases) were performed at baseline, 1, and 2 hours after treatment. Results: All measured PFT parameters significantly increased in both groups, but numerically results were better after inhalation with VMN than with JN: for forced expiratory volume in 1 second (FEV 1 ) (mean increase from baseline to 120 minutes-165 ± 64 mL vs. 116 ± 46 mL, p  = 0.001) and for forced vital capacity (FVC) (mean increase-394 ± 154 mL vs. 123 ± 57 mL, p  < 0.001). There was also a statistically significant reduction in respiratory rate and in Borg dyspnea score after therapy with VMN in comparison with the conventional JN. In both groups, there were improvements in PaCO 2 , but with VMN these changes were significantly higher. Conclusion: Bronchodilator administration in patients with acute exacerbation of COPD during NIV with VMN resulted in clinically significant improvements in FVC and in Borg dyspnea score. Additional studies required to determine the impact on clinical outcomes.",2021,There was also a statistically significant reduction in respiratory rate and in Borg dyspnea score after therapy with VMN in comparison with the conventional JN.,"['Acute Exacerbation of Chronic Obstructive Pulmonary Disease', 'patients with acute exacerbation of COPD during NIV with', '30 patients treated with NIV for acute exacerbation of COPD in an acute care hospital', 'patients with acute exacerbation of COPD', 'Patients were consented and enrolled after stabilization of acute exacerbation (3-5 days after admission', 'acute exacerbation of chronic obstructive pulmonary disease (COPD']","['salbutamol (2.5\u2009mg): with VMN (Aerogen Solo) and JN (Sidestream) positioned between the leak port and the nonvented oronasal mask during bilevel ventilation with a single-limb circuit', 'VMN', 'Noninvasive Ventilation', 'aerosol therapy', 'Vibrating Mesh and Jet Nebulizers', 'vibrating mesh nebulizer (VMN) and jet nebulizer (JN', 'bronchodilators']","['PFT parameters', 'respiratory rate and in Borg dyspnea score', 'FVC and in Borg dyspnea score', 'forced expiratory volume', 'Measurements (clinical data, pulmonary function tests [PFTs], and arterial blood gases', 'forced vital capacity (FVC']","[{'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751673', 'cui_str': 'Nipah virus'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3661916', 'cui_str': 'Acute care hospital'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C3714568', 'cui_str': 'Aerosol therapy'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0336862', 'cui_str': 'Jet airplane'}, {'cui': 'C0027524', 'cui_str': 'Nebulizer'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}]",30.0,0.127234,There was also a statistically significant reduction in respiratory rate and in Borg dyspnea score after therapy with VMN in comparison with the conventional JN.,"[{'ForeName': 'Sergey N', 'Initials': 'SN', 'LastName': 'Avdeev', 'Affiliation': 'Sechenov First Moscow State Medical University, Healthcare Ministry of Russia, Moscow, Russia.'}, {'ForeName': 'Galia S', 'Initials': 'GS', 'LastName': 'Nuralieva', 'Affiliation': 'Sechenov First Moscow State Medical University, Healthcare Ministry of Russia, Moscow, Russia.'}, {'ForeName': 'Aung Kyaw', 'Initials': 'AK', 'LastName': 'Soe', 'Affiliation': 'Federal Pulmonology Research Institute, Moscow, Federal Medical and Biological Agency of Russia, Moscow, Russia.'}, {'ForeName': 'Viliya V', 'Initials': 'VV', 'LastName': 'Gainitdinova', 'Affiliation': 'Sechenov First Moscow State Medical University, Healthcare Ministry of Russia, Moscow, Russia.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Fink', 'Affiliation': 'Division of Respiratory Care, Department of Cardiopulmonary Sciences, Rush University Medical Center, Chicago, Illinois, USA.'}]",Journal of aerosol medicine and pulmonary drug delivery,['10.1089/jamp.2020.1665'] 3618,33848338,"Safety, Pharmacokinetics, and Pharmacodynamics of Spectrum Red Softgels in Healthy Participants.","Due to a lack of published pharmacokinetic (PK) and/or pharmacodynamic (PD) data, informed physician and patient decision-making surrounding appropriate dosing of cannabis for medical purposes is limited. This Phase 1, multiple-dose study evaluated the safety, tolerability, PK, and PD of Spectrum Red softgels (2.5 mg Δ9-tetrahydrocannabinol (THC) and < 0.25 mg cannabidiol (CBD)). Participants (N = 41) were randomized to one of five groups: 5 mg THC and 0.06 mg CBD daily (Treatment A), 10 mg THC and 0.12 mg CBD daily (Treatment B), 15 mg THC and 0.18 mg CBD daily (Treatment C), 20 mg THC and 0.24 mg CBD daily (Treatment D), or placebo. Study medication was administered in divided doses, every 12 hours, approximately 60 minutes after a standardized meal, for seven consecutive days. All treatment-emergent adverse events (TEAEs) (65/65) were of mild to moderate severety; none was serious. The highest number of TEAEs (30/65) occurred on the first day of treatment. The most common TEAEs included somnolence, lethargy, and headache (reported by 8, 7, and 5 participants, respectively). On Day 7, maximum observed plasma concentration of 11-carboxy-THC increased by 2.0- and 2.5-fold as the dose doubled between Treatments A and B and between Treatments B and D, respectively. Mean peak post-treatment ratings of self-reported subjective effects of ""feel any effect"" and ""dazed"" differed between Treatment D and placebo on Days 1, 3, and 7. Over a week of twice-daily dosing of Spectrum Red softgels, daily doses of THC up to 20 mg and of CBD up to 0.24 mg were generally safe and became better tolerated after the first day of treatment. A prudent approach to improve tolerability with Spectrum Red softgels might involve initial daily doses no higher than 10 mg THC and 0.12 mg CBD in divided doses, with titration upwards over time as needed based on tolerability.",2021,"Mean peak post-treatment ratings of self-reported subjective effects of ""feel any effect"" and ""dazed"" differed between Treatment D and placebo on Days 1, 3, and 7.","['Healthy Participants', 'Participants (N = 41']","['Δ9-tetrahydrocannabinol (THC) and < 0.25 mg cannabidiol (CBD', 'THC', 'THC and 0.24 mg CBD daily (Treatment D), or placebo', 'placebo']","['plasma concentration of 11-carboxy-THC', 'Safety, Pharmacokinetics, and Pharmacodynamics of Spectrum Red Softgels', 'tolerability', 'somnolence, lethargy, and headache', 'safety, tolerability, PK, and PD of Spectrum Red softgels']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C4517441', 'cui_str': '0.24'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0023380', 'cui_str': 'Lethargy'}, {'cui': 'C0018681', 'cui_str': 'Headache'}]",41.0,0.0699744,"Mean peak post-treatment ratings of self-reported subjective effects of ""feel any effect"" and ""dazed"" differed between Treatment D and placebo on Days 1, 3, and 7.","[{'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Peters', 'Affiliation': 'Canopy Growth Corporation, Smiths Falls, Ontario, Canada.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Mosesova', 'Affiliation': 'Canopy Growth Corporation, Smiths Falls, Ontario, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'MacNair', 'Affiliation': 'Canopy Growth Corporation, Smiths Falls, Ontario, Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Vandrey', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'M Hunter', 'Initials': 'MH', 'LastName': 'Land', 'Affiliation': 'Canopy Growth Corporation, Smiths Falls, Ontario, Canada.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Ware', 'Affiliation': 'Canopy Growth Corporation, Smiths Falls, Ontario, Canada.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Turcotte', 'Affiliation': 'Canopy Growth Corporation, Smiths Falls, Ontario, Canada.'}, {'ForeName': 'Marcel O', 'Initials': 'MO', 'LastName': 'Bonn-Miller', 'Affiliation': 'Canopy Growth Corporation, Smiths Falls, Ontario, Canada.'}]",Journal of analytical toxicology,['10.1093/jat/bkab035'] 3619,33848325,Assessment of preparation time and 1-year Invisalign aligner attachment survival using flowable and packable composites.,"OBJECTIVES To compare preparation time and 1-year Invisalign aligner attachment survival between a flowable composite (FC) and a packable composite (PC). MATERIALS AND METHODS Fifty-five participants (13 men and 42 women, mean age ± SD: 24.2 ± 5.9 years) were included in the study. Ipsilateral quadrants (ie, maxillary and mandibular right, or vice versa) of attachments were randomly assigned to the FC group (Filtek Z350XT Flowable Restorative) and the PC group (Filtek Z350XT Universal Restorative) by tossing a coin. The primary outcome was preparation time. The secondary outcome was time to the first damage of an attachment. Preparation times were compared using the paired t-test, and the survival data were analyzed by the Cox proportional hazards model with a shared frailty term, with α = .05. RESULTS The preparation times were significantly shorter with the FC (6.22 ± 0.22 seconds per attachment) than with the PC (32.83 ± 2.16 seconds per attachment; P < .001). The attachment damage rates were 14.79% for the FC and 9.70% for the PC. According to the Cox models, attachment damage was not significantly affected by the attachment material, sex, arch, tooth location, attachment type, presence of overbite, or occurrence of tooth extraction. CONCLUSIONS The use of a FC may save time as compared with the use of a PC. With regard to attachment survival, there was no significant difference between the two composites. None of the covariates of attachment materials (sex, arch, tooth location, attachment type, presence of overbite, oir occurrence of tooth extraction) affected attachment damage.",2021,"According to the Cox models, attachment damage was not significantly affected by the attachment material, sex, arch, tooth location, attachment type, presence of overbite, or occurrence of tooth extraction. ","['Fifty-five participants (13 men and 42 women, mean age ± SD: 24.2 ± 5.9 years']","['FC group (Filtek Z350XT Flowable Restorative) and the PC group (Filtek Z350XT Universal Restorative) by tossing a coin', 'flowable and packable composites', 'flowable composite (FC) and a packable composite (PC']","['time to the first damage of an attachment', 'attachment damage rates', 'preparation time and 1-year Invisalign aligner attachment survival', 'attachment material, sex, arch, tooth location, attachment type, presence of overbite, or occurrence of tooth extraction', 'survival data', 'preparation time', 'attachment survival']","[{'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0673997', 'cui_str': 'flowable hybrid composite'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0524669', 'cui_str': 'Coins'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4704905', 'cui_str': 'Invisalign'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1305740', 'cui_str': 'Overbite'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}]",55.0,0.0648121,"According to the Cox models, attachment damage was not significantly affected by the attachment material, sex, arch, tooth location, attachment type, presence of overbite, or occurrence of tooth extraction. ","[{'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Jialing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wen', 'Affiliation': ''}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Mei', 'Affiliation': ''}, {'ForeName': 'Haipeng', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Huang', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ''}]",The Angle orthodontist,['10.2319/063020-598.1'] 3620,33848307,Effect of aromatherapy on autonomic nervous system regulation with treadmill exercise-induced stress among adolescents.,"INTRODUCTION Stress is a major health issue in adolescents owing to the important transitions experienced during this period. Aromatherapy is an effective method for the reduction of stress in adolescents. PURPOSE The aims of this study were to examine the effect of aromatherapy on the regulation of the autonomic nervous system (ANS) along with stress relief and to explore the effect of aromatherapy on adolescents with different levels of stress. METHODS This quasi-experimental study comprised three types of treatments: control (no essential oil), pure essential oil therapy (sandalwood), and blended essential oil therapy (sandalwood-lavender). The heart rate variability (HRV) was calculated to evaluate the post-exercise recovery of the ANS to the baseline level in the recruited adolescents. To examine the efficiency of aromatherapy, Friedman test was used to assess the significance of difference in all parameters (i.e., mean heart rate, SDNN, normalized LF, normalized HF, and LF/HF) between baseline and after exercise among the three treatment conditions. RESULTS The participants comprised 43 junior college students (8 males and 35 females) with a mean age of 18.21 ± 0.99. Significant differences in changes of two HRV parameters (normalized LF and LF/HF) were associated with both essential oil therapies compared to those in the control group (p<0.05), and one more HRV parameter (normalized HF) exhibited significant difference related to blended essential oil therapy compared to that of the control group. Besides, changes in two HRV parameters (mean heart rate and normalized HF) of both essential oil therapies in the low level stress subgroup showed significant differences compared to those of the control group (p<0.05). CONCLUSIONS This study demonstrated that aromatherapy could be used for ANS regulation with stress-relieving effects in adolescents. The participants with a low stress level appeared to respond better to the blended essential oil therapy, whereas those with medium to high levels of stress appeared to respond poorly to aromatherapy compared to the control.",2021,"Significant differences in changes of two HRV parameters (normalized LF and LF/HF) were associated with both essential oil therapies compared to those in the control group (p<0.05), and one more HRV parameter (normalized HF) exhibited significant difference related to blended essential oil therapy compared to that of the control group.","['43 junior college students (8 males and 35 females) with a mean age of 18.21 ± 0.99', 'adolescents', 'adolescents with different levels of stress']","['aromatherapy', 'Aromatherapy', 'control (no essential oil), pure essential oil therapy (sandalwood), and blended essential oil therapy (sandalwood-lavender']","['changes of two HRV parameters (normalized LF and LF/HF', 'mean heart rate, SDNN, normalized LF, normalized HF, and LF/HF', 'heart rate variability (HRV']","[{'cui': 'C0557812', 'cui_str': 'Community college'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517488', 'cui_str': '0.99'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]","[{'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1005958', 'cui_str': 'Sandalwood'}, {'cui': 'C0524903', 'cui_str': 'Lavender'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0426375,"Significant differences in changes of two HRV parameters (normalized LF and LF/HF) were associated with both essential oil therapies compared to those in the control group (p<0.05), and one more HRV parameter (normalized HF) exhibited significant difference related to blended essential oil therapy compared to that of the control group.","[{'ForeName': 'Pin-Hsuan', 'Initials': 'PH', 'LastName': 'Lin', 'Affiliation': 'Department of Health and Beauty, Shu Zen Junior College of Medicine and Management, Kaohsiung, Taiwan.'}, {'ForeName': 'Yuan-Ping', 'Initials': 'YP', 'LastName': 'Lin', 'Affiliation': 'Department of Health and Beauty, Shu Zen Junior College of Medicine and Management, Kaohsiung, Taiwan.'}, {'ForeName': 'Kai-Li', 'Initials': 'KL', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, College of Pharmacy and Health Care, Tajen University, Pingtung, Taiwan.'}, {'ForeName': 'Shang-Yu', 'Initials': 'SY', 'LastName': 'Yang', 'Affiliation': 'Department of Healthcare Administration, College of Medical and Health Science, Asia University, Taichung, Taiwan.'}, {'ForeName': 'Yin-Hwa', 'Initials': 'YH', 'LastName': 'Shih', 'Affiliation': 'Department of Healthcare Administration, College of Medical and Health Science, Asia University, Taichung, Taiwan.'}, {'ForeName': 'Po-Yu', 'Initials': 'PY', 'LastName': 'Wang', 'Affiliation': 'Department of Pediatric Emergency, Changhua Christian Children Hospital, Changhua, Taiwan.'}]",PloS one,['10.1371/journal.pone.0249795'] 3621,33848255,Correction: Spelling Errors and Shouting Capitalization Lead to Additive Penalties to Trustworthiness of Online Health Information: Randomized Experiment With Laypersons.,[This corrects the article DOI: 10.2196/15171.].,2021,[This corrects the article DOI: 10.2196/15171.].,[],['Correction: Spelling Errors and Shouting Capitalization Lead to Additive Penalties to Trustworthiness of Online Health Information'],[],[],"[{'cui': 'C0562551', 'cui_str': 'Shouting'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0442796', 'cui_str': 'Additive'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",[],,0.0838946,[This corrects the article DOI: 10.2196/15171.].,"[{'ForeName': 'Harry J', 'Initials': 'HJ', 'LastName': 'Witchel', 'Affiliation': 'Department of Neuroscience, Brighton and Sussex Medical School, Brighton, United Kingdom.'}, {'ForeName': 'Georgina A', 'Initials': 'GA', 'LastName': 'Thompson', 'Affiliation': 'Department of Neuroscience, Brighton and Sussex Medical School, Brighton, United Kingdom.'}, {'ForeName': 'Christopher I', 'Initials': 'CI', 'LastName': 'Jones', 'Affiliation': 'Department of Primary Care and Public Health, Brighton and Sussex Medical School, Brighton, United Kingdom.'}, {'ForeName': 'Carina E I', 'Initials': 'CEI', 'LastName': 'Westling', 'Affiliation': 'Faculty of Media and Communication, Bournemouth University, Bournemouth, United Kingdom.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Romero', 'Affiliation': 'Dalton Maag Ltd, London, United Kingdom.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Nicotra', 'Affiliation': 'Dalton Maag Ltd, London, United Kingdom.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Maag', 'Affiliation': 'Dalton Maag Ltd, London, United Kingdom.'}, {'ForeName': 'Hugo D', 'Initials': 'HD', 'LastName': 'Critchley', 'Affiliation': 'Department of Neuroscience, Brighton and Sussex Medical School, Brighton, United Kingdom.'}]",Journal of medical Internet research,['10.2196/29452'] 3622,33848229,The role of radiotherapy in neuroendocrine cervical cancer: SEER-based study.,"BACKGROUND There are few randomised prospective data or guidelines for the treatment of neuroendocrine cervical cancer (NECC). In addition, the role of radiotherapy (RT) in NECC remains controversial. We used the Surveillance Epidemiology and End Results (SEER) database to investigate the role of RT for the treatment of NECC. Particular attention was paid to the different role of RT in patients with or without a metastasis (M1 or M0). METHODS The SEER database was queried for studies on NECC. We limited the year of diagnosis to the years 2000 to 2015. A Pearson's two-sided Chi-squared test, the Kaplan-Meier method and Cox regression analysis models were used for statistical analyses. The overall survival (OS) was studied for the overall group and between-subgroup groups. RESULTS NECC was an aggressive disease with a mean OS of only 46.3 months (range of 0-196 months, median of 23 months). No significant differences were shown between the surgery (S) and S + RT groups ( p  = 0.146) in the M0 (without metastasis) arm. However, there was a statistically significant difference in OS between the S and S + RT groups in the M1 (with metastasis) arm (median of 44.6 months for the S group and 80.9 months for the S + RT group), p  = 0.004. The mean survival was significantly longer for M0 patients than for M1 patients when treated with S only (S arm), that is, 82.1 months versus 44.6 months, respectively (log-rank p  = 0.000). We also noted that when patients received adjuvant RT (S + RT arm), there were no significant differences between the M0 and M1 groups (median of 90.6 and 81.0 months, p  = 0.704, respectively). Age at diagnosis, chemotherapy, T stage and N stage were significant factors for OS in the M0 arm. Interestingly, radiotherapy was the only significant factor for OS with a multivariate HR for death of 0.502 (95% CI 0.206-0.750, p  = 0.006) in the M1 arm. CONCLUSIONS RT may be carefully used in patients who are negative for metastases. Using SEER data, we identified a significant survival advantage with the combination of radiotherapy and surgery in NECC with metastases. This suggests that active local treatment should be conducted and has a significant impact on OS, even if a distant metastasis has occurred.",2021,No significant differences were shown between the surgery (S) and S + RT groups ( p  = 0.146) in the M0 (without metastasis) arm.,"['neuroendocrine cervical cancer', 'neuroendocrine cervical cancer (NECC', 'patients who are negative for metastases', 'patients with or without a metastasis (M1 or M0']","['radiotherapy (RT', 'radiotherapy']","['OS', 'mean survival', 'overall survival (OS']","[{'cui': 'C0027912', 'cui_str': 'Neuroendocrine System'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0300026,No significant differences were shown between the surgery (S) and S + RT groups ( p  = 0.146) in the M0 (without metastasis) arm.,"[{'ForeName': 'Meilian', 'Initials': 'M', 'LastName': 'Dong', 'Affiliation': 'Department of Radiation Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.'}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': 'Department of Radiation Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.'}, {'ForeName': 'Taoran', 'Initials': 'T', 'LastName': 'Ma', 'Affiliation': 'Department of Education Section, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Mi', 'Affiliation': 'Department of Radiation Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.'}, {'ForeName': 'Yonggang', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Radiation Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.'}, {'ForeName': 'Ruitai', 'Initials': 'R', 'LastName': 'Fan', 'Affiliation': 'Department of Radiation Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.'}]",Science progress,['10.1177/00368504211009336'] 3623,33848232,Reduced mucosal immunity to poliovirus after cessation of trivalent oral polio vaccine.,"The switch from using only trivalent oral polio vaccine (tOPV) to sequential schedules combining inactivated poliovirus vaccine (IPV) and bivalent oral polio vaccine (bOPV) for polio vaccination will cause changes to mucosal immunity against polio in infants, which plays an important role in preventing the poliovirus spread. Here, we analyzed mucosal immunity against poliovirus in the intestine during different sequential vaccination schedules. We conducted clinical trials in Guangxi Province, China on 1,200 2-month-old infants who were randomly assigned to one of three vaccination schedule groups: IPV-bOPV-bOPV, IPV-IPV-tOPV, and IPV-IPV-bOPV, with vaccine doses administered at 8, 12, and 16 weeks of age. Stool samples were collected from 10% of participants in each group before administration of the second vaccine doses and at 1, 2, and 4 weeks after the administrations of the second and third vaccine doses. Immunoglobulin A (IgA) in the stool samples was measured to analyze the mucosal immune response in the intestine. Because of the absence of poliovirus type 2 in bOPV, the vaccination schedule of IPV-IPV-bOPV did not sufficiently raise intestinal mucosal immunity against poliovirus type 2, although some cross-immunity was seen. The level of intestinal mucosal immunity was related to shedding status; shedders could produce intestinal mucosa IgA more quickly. The intestinal mucosal immunity level was not related to serum neutralizing antibody level. In the combined sequential vaccination schedule of IPV and bOPV, the risk of circulating vaccine-derived poliovirus type 2 (cVDPV2) may be increased owing to insufficient intestinal mucosal immunity against poliovirus type 2.",2021,The intestinal mucosal immunity level was not related to serum neutralizing antibody level.,"['Guangxi Province, China on 1,200 2-month-old infants']","['trivalent oral polio vaccine', 'trivalent oral polio vaccine (tOPV', 'IPV-bOPV-bOPV, IPV-IPV-tOPV, and IPV-IPV-bOPV, with vaccine', 'poliovirus vaccine (IPV) and bivalent oral polio vaccine (bOPV']","['mucosal immune response', 'intestinal mucosal immunity level', 'Stool samples', 'level of intestinal mucosal immunity']","[{'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0032375', 'cui_str': 'Sabin Vaccine'}, {'cui': 'C0036106', 'cui_str': 'Salk Vaccine'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032374', 'cui_str': 'Poliovirus vaccine'}]","[{'cui': 'C0282557', 'cui_str': 'Immune Response, Mucosal'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0282558', 'cui_str': 'Mucosal Immunity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1550661', 'cui_str': 'Stool specimen'}]",,0.133819,The intestinal mucosal immunity level was not related to serum neutralizing antibody level.,"[{'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Zhao', 'Affiliation': 'Yunnan Key Laboratory of Vaccine Research & Development on Severe Infectious Disease, Institute of Medical Biology, Chinese Academy of Medical Sciences & Peking Union Medical College, Kunming, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Yunnan Key Laboratory of Vaccine Research & Development on Severe Infectious Disease, Institute of Medical Biology, Chinese Academy of Medical Sciences & Peking Union Medical College, Kunming, China.'}, {'ForeName': 'Hongyuan', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Yunnan Key Laboratory of Vaccine Research & Development on Severe Infectious Disease, Institute of Medical Biology, Chinese Academy of Medical Sciences & Peking Union Medical College, Kunming, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Ye', 'Affiliation': ""Hangzhou Women's Hospital Hangzhou Maternity and Child Health Care Hospital, Hangzhou, China.""}, {'ForeName': 'Rufei', 'Initials': 'R', 'LastName': 'Ma', 'Affiliation': 'Yunnan Key Laboratory of Vaccine Research & Development on Severe Infectious Disease, Institute of Medical Biology, Chinese Academy of Medical Sciences & Peking Union Medical College, Kunming, China.'}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Fu', 'Affiliation': 'Yunnan Key Laboratory of Vaccine Research & Development on Severe Infectious Disease, Institute of Medical Biology, Chinese Academy of Medical Sciences & Peking Union Medical College, Kunming, China.'}, {'ForeName': 'Xiaochang', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Tianjin Centers for Disease Control and Prevention, Tianjin, China.'}, {'ForeName': 'Guoliang', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Yunnan Key Laboratory of Vaccine Research & Development on Severe Infectious Disease, Institute of Medical Biology, Chinese Academy of Medical Sciences & Peking Union Medical College, Kunming, China.'}, {'ForeName': 'Xiaolei', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Yunnan Key Laboratory of Vaccine Research & Development on Severe Infectious Disease, Institute of Medical Biology, Chinese Academy of Medical Sciences & Peking Union Medical College, Kunming, China.'}, {'ForeName': 'Zhimei', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Yunnan Key Laboratory of Vaccine Research & Development on Severe Infectious Disease, Institute of Medical Biology, Chinese Academy of Medical Sciences & Peking Union Medical College, Kunming, China.'}, {'ForeName': 'Jingsi', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Yunnan Key Laboratory of Vaccine Research & Development on Severe Infectious Disease, Institute of Medical Biology, Chinese Academy of Medical Sciences & Peking Union Medical College, Kunming, China.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2021.1911213'] 3624,33848199,Treatment-Related Changes in Left Atrial Structure in Atrial Fibrillation: Findings from the CABANA Imaging Substudy.,"Background - The Catheter Ablation versus Antiarrhythmic Drug Therapy for Atrial Fibrillation (CABANA) trial was a randomized, prospective trial of left atrial catheter ablation versus drug therapy for treatment of atrial fibrillation (AF). As part of CABANA, a prospective imaging sub-study was conducted. The main objectives were to describe the patterns of changes in the dimensions of the left atrium (LA) and pulmonary veins (PVs), and the relationship between these changes with treatment assignment and clinical outcomes. Methods - CT or MRI was acquired at baseline and follow-up in 121 ablation (median follow-up 101 days) and 85 drug patients (median follow-up 97 days). Left atrial volume index (LAVI), mean PV ostial diameter (MPV) , and ostial diameters of each PV separately were computed. We examined the relationship between the change from baseline to follow-up with subsequent clinical outcomes (composite of death, disabling stroke, serious bleeding, or cardiac arrest [CABANA primary endpoint], total mortality or cardiovascular hospitalization, first AF recurrence after the 90 day blanking period, first AF/atrial flutter/ atrial tachycardia after the 90 day blanking period) using Cox proportional-hazards models. Results - The median (25 th , 75 th ) change from baseline for LAVI was -7.8 mL/m 2 (-16.4, 0.2), ablation arm and -3.5 mL/m 2 (-11.4, 2.6), drug therapy arm. The LAVI decreased in 52.9% of ablation patients versus 40.0% of drug therapy patients. Change for MPV was -2.7 mm (-4.2, -1.3) in the ablation arm versus -0.1 mm (-1.5, 0.8) in the drug therapy arm. Changes in LA and PV dimensions had no consistent relationship with the risk of developing the study primary endpoint. Reductions in LAVI, and in MPV diameter were associated with decreased risk of AF recurrence. Conclusions - Ablation patients demonstrated more frequent and larger atrial structural changes compared with drug patients. These changes suggest a critical relationship between structural features and AF generation.",2021,"The median (25 th , 75 th ) change from baseline for LAVI was -7.8","['atrial fibrillation (AF', 'Atrial Fibrillation']","[' - The Catheter Ablation versus Antiarrhythmic Drug Therapy', 'left atrial catheter ablation']","['Reductions in LAVI, and in MPV diameter', 'risk of AF recurrence', 'frequent and larger atrial structural changes', 'LAVI', 'clinical outcomes (composite of death, disabling stroke, serious bleeding, or cardiac arrest [CABANA primary endpoint], total mortality or cardiovascular hospitalization, first AF recurrence after the 90 day blanking period, first AF/atrial flutter/ atrial tachycardia', 'Left atrial volume index (LAVI), mean PV ostial diameter (MPV) , and ostial diameters of each PV', 'dimensions of the left atrium (LA) and pulmonary veins (PVs', 'Change for MPV']","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]","[{'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0200665', 'cui_str': 'Platelet mean volume determination'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030587', 'cui_str': 'Atrial paroxysmal tachycardia'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0225860', 'cui_str': 'Left atrial structure'}, {'cui': 'C0034090', 'cui_str': 'Structure of vein of pulmonary circulation'}]",121.0,0.0596789,"The median (25 th , 75 th ) change from baseline for LAVI was -7.8","[{'ForeName': 'Maryam E', 'Initials': 'ME', 'LastName': 'Rettmann', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Holmes Iii', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Kristi H', 'Initials': 'KH', 'LastName': 'Monahan', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Jerome F', 'Initials': 'JF', 'LastName': 'Breen', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Tristram D', 'Initials': 'TD', 'LastName': 'Bahnson', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Mark', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Poole', 'Affiliation': 'University of Washington Medical Center, Seattle, WA.'}, {'ForeName': 'Alicia M', 'Initials': 'AM', 'LastName': 'Ellis', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Silverstein', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Hussein R', 'Initials': 'HR', 'LastName': 'Al-Khalidi', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Kerry L', 'Initials': 'KL', 'LastName': 'Lee', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Robb', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Packer', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.120.008540'] 3625,33848193,A Pilot Study of a Collaborative Palliative and Oncology Care Intervention for Patients with Head and Neck Cancer.,"Background: Palliative care improves symptoms and coping in patients with advanced cancers, but has not been evaluated for patients with curable solid malignancies. Because of the tremendous symptom burden and high rates of psychological distress in head and neck cancer (HNC), we evaluated feasibility and acceptability of a palliative care intervention in patients with HNC receiving curative-intent chemoradiation therapy (CRT). Methods: This was a prospective single-arm study in HNC patients receiving CRT at a single center in the United States. The intervention entailed weekly palliative care visits integrated with oncology care with a focus on symptoms and coping. The primary outcome was feasibility, defined as a >50% enrollment rate with >70% of patients attending at least half of the visits. To assess acceptability, we collected satisfaction ratings post-intervention. We also explored symptom burden, mood, and quality of life (QOL). Results: We enrolled 91% (20/22) of eligible patients. Patients attended 133 of 138 palliative care visits (96%); all 20 attended >85% of visits. Eighteen of 19 (95%) found the intervention ""very helpful"" and would ""definitely recommend"" it. QOL and symptom burden worsened from baseline to week 5, but subsequently improved at one-month post-CRT. Overall, patients valued the one-on-one format of the intervention and receipt of additional care. Conclusions: Our palliative care intervention during highly morbid CRT was feasible and acceptable with high enrollment, excellent intervention compliance, and high patient satisfaction. Future randomized studies will further explore the impact on patient-reported outcomes and health care utilization.",2021,"QOL and symptom burden worsened from baseline to week 5, but subsequently improved at one-month post-CRT.","['head and neck cancer (HNC', 'patients with advanced cancers', 'patients with curable solid malignancies', 'Patients attended 133 of 138 palliative care visits (96%); all 20 attended >85% of visits', 'patients with HNC receiving curative-intent chemoradiation therapy (CRT', 'HNC patients receiving CRT at a single center in the United States', 'Patients with Head and Neck Cancer']","['palliative care intervention', 'Collaborative Palliative and Oncology Care Intervention', 'intervention entailed weekly palliative care visits integrated with oncology care with a focus on symptoms and coping', 'Palliative care']","['QOL and symptom burden', 'symptom burden, mood, and quality of life (QOL']","[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C1721358', 'cui_str': 'MMP8 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",138.0,0.0322037,"QOL and symptom burden worsened from baseline to week 5, but subsequently improved at one-month post-CRT.","[{'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Bauman', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Jessie R', 'Initials': 'JR', 'LastName': 'Panick', 'Affiliation': 'Cancer Prevention and Control Program, Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Galloway', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Ridge', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Marcin A', 'Initials': 'MA', 'LastName': 'Chwistek', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Molly E', 'Initials': 'ME', 'LastName': 'Collins', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Kinczewski', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Murphy', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Welsh', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Farren', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Mollie Clark', 'Initials': 'MC', 'LastName': 'Omilak', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Kelly', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Schuster', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Lucas', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Amrhein', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Florence P', 'Initials': 'FP', 'LastName': 'Bender', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Temel', 'Affiliation': 'Hematology-Oncology, Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Egleston', 'Affiliation': 'Biostatistics and Bioinformatics Facility, Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Areej', 'Initials': 'A', 'LastName': 'El-Jawahri', 'Affiliation': 'Hematology-Oncology, Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Carolyn Y', 'Initials': 'CY', 'LastName': 'Fang', 'Affiliation': 'Cancer Prevention and Control Program, Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.'}]",Journal of palliative medicine,['10.1089/jpm.2020.0656'] 3626,33848070,Parasacral transcutaneous electrical nerve stimulation in children with overactive bladder: comparison between sessions administered two and three times weekly.,"PURPOSE This study compares the results achieved following parasacral TENS administered using two different weekly schedules. MATERIALS AND METHODS Children of at least four years of age with a diagnosis of pure overactive bladder were included in this randomized clinical trial and treated with parasacral TENS (2 versus 3 sessions per week). All the participants also underwent standard urotherapy. RESULTS Sixteen children were included in the twice-weekly group and eighteen in the three times weekly group. There were no statistically significant differences between the two groups with respect to sex; however, there was a difference in age. There were no significant differences regarding complete resolution of urinary symptoms, with 8 children (50%) in the twice-weekly group and 11 children (61%) in the three times weekly group having their symptoms completely resolved (p=0.73). There was a significant difference in the DVSS score in both groups following TENS treatment compared to baseline (p=0.0001 for both groups), but not between groups. Evaluation of the bladder diary showed no difference between the groups before or after treatment. CONCLUSION For children with overactive bladder who are unable to undergo parasacral TENS treatment three times weekly, the method can be administered successfully at twice-weekly sessions.",2021,"There were no statistically significant differences between the two groups with respect to sex; however, there was a difference in age.","['Children of at least four years of age with a diagnosis of pure overactive bladder', 'children with overactive bladder', 'Sixteen children']","['Parasacral transcutaneous electrical nerve stimulation', 'parasacral TENS']","['complete resolution of urinary symptoms', 'DVSS score']","[{'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0014518', 'cui_str': 'Lyell syndrome'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",16.0,0.0261023,"There were no statistically significant differences between the two groups with respect to sex; however, there was a difference in age.","[{'ForeName': 'Maria Luiza', 'Initials': 'ML', 'LastName': 'Veiga', 'Affiliation': 'Departamento de Fisioterapia, Escola Bahiana de Medicina, Salvador, BA, Brasil.'}, {'ForeName': 'Kaíse', 'Initials': 'K', 'LastName': 'Oliveira', 'Affiliation': 'Escola Bahiana de Medicina e Saude Publica Salvador, BA, Brasil.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Batista', 'Affiliation': 'Escola Bahiana de Medicina e Saude Publica Salvador, BA, Brasil.'}, {'ForeName': 'Ananda', 'Initials': 'A', 'LastName': 'Nacif', 'Affiliation': 'Escola Bahiana de Medicina e Saude Publica Salvador, BA, Brasil.'}, {'ForeName': 'Ana Aparecida Martinelli', 'Initials': 'AAM', 'LastName': 'Braga', 'Affiliation': 'Escola Bahiana de Medicina e Saude Publica Salvador, BA, Brasil.'}, {'ForeName': 'Ubirajara', 'Initials': 'U', 'LastName': 'Barroso', 'Affiliation': 'Departamento de Urologia, Universidade Federal da Bahia - UFBA, Salvador, BA, Brasil.'}]",International braz j urol : official journal of the Brazilian Society of Urology,['10.1590/S1677-5538.IBJU.2020.0372'] 3627,33847706,Quality of health care perceived by users in Catalan prisons.,"OBJECTIVES To describe inmates' perceptions of healthcare quality in Catalonian prisons. MATERIAL AND METHOD Transversal study of 6,856 inmates in Catalan prisons in September 2017. Randomized simple screening was used to randomly distribute 1,048 polls in which different aspects of perceived quality of healthcare were evaluated. The results were also categorized according to age, sex, time spent in prison, background and academic levels. We also analysed the differences between results in healthcare quality according to socio-demographic variables. RESULTS 84.87% of patients show satisfaction with the quality of healthcare received. Women are more satisfied with consultations than men (OR: 2.04; p = 0.009). Patients with a higher educational level are less satisfied than those with a lower educational level, with significant differences in 11 of the 14 items. Those over 65 years of age were more satisfied than the rest in 11 of the 14 items evaluated. Foreign patients were more satisfied than Spanish inmates in time flexibility (OR: 0.69; p = 0.018) and in waiting times for visits (OR: 0,63; p = 0.006), whereas they are less satisfied with the healthcare professionals' image (OR: 1.97; p = 0.03). DISCUSSION Noteble features of our study include the fact that although global satisfaction is high, some dimensions, like reliability, could improve. The results were submitted to the General Directorate to enable more in-depth study of the variables where there is less satisfaction and to design further improvements.",2021,"Foreign patients were more satisfied than Spanish inmates in time flexibility (OR: 0.69; p = 0.018) and in waiting times for visits (OR: 0,63; p = 0.006), whereas they are less satisfied with the healthcare professionals' image (OR: 1.97; p = 0.03). ","['Transversal study of 6,856 inmates in Catalan prisons in September 2017', ""inmates' perceptions of healthcare quality in Catalonian prisons""]",[],"['Quality of health care', 'time flexibility', 'waiting times for visits']","[{'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}]",[],"[{'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",6856.0,0.02178,"Foreign patients were more satisfied than Spanish inmates in time flexibility (OR: 0.69; p = 0.018) and in waiting times for visits (OR: 0,63; p = 0.006), whereas they are less satisfied with the healthcare professionals' image (OR: 1.97; p = 0.03). ","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'García-González', 'Affiliation': 'Lledoners Prison. Catalonian Institute of Health. Barcelona.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mendioroz-Peña', 'Affiliation': 'Central Catalonia Territorial Management. Catalonian Institute of Health. Barcelona.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Armenteros-López', 'Affiliation': 'Penitenciario Quatre Camins Prison. Catalonian Institute of Health. Barcelona.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Sole-Zapata', 'Affiliation': 'Brians 1 Prison. Catalonian Institute of Health. Barcelona.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Alonso-Gaitón', 'Affiliation': 'Brians 2 Prison. Catalonian Institute of Health. Barcelona.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Cuadro-Pena', 'Affiliation': ""Mas D'Enric Prison. Catalonian Institute of Health. Tarragona.""}]",Revista espanola de sanidad penitenciaria,['10.18176/resp.00026'] 3628,33847683,Myocardial protective effect of intracoronary administration of nicorandil and alprostadil via targeted perfusion microcatheter in patients undergoing elective percutaneous coronary intervention: A randomized controlled trial.,"BACKGROUND The aim of the study was to evaluate the efficacy of nicorandil and alprostadil on myocardial protection in patients undergoing elective percutaneous coronary intervention (PCI). METHODS In this prospective, single-blinded, randomized controlled study, 90 consecutive patients scheduled for elective PCI for de novo coronary lesions were assigned to the nicorandil, alprostadil, and nitroglycerin groups in a 1:1:1 ratio. Drugs were administered intracoronary via a targeted perfusion microcatheter. The primary endpoint was the thrombolysis in myocardial infarction (TIMI) myocardial perfusion frame count (TMPFC). Additionally, the corrected TIMI frame count (cTFC), TIMI myocardial perfusion grade (TMPG), and incidence of periprocedural myocardial injury (PMI) were assessed. RESULTS Both nicorandil and alprostadil were significantly effective in reducing TMPFC (114.6 ± 33.7 vs 93.4 ± 30.9, P = .016; 114.3 ± 34.3 vs 94.7 ± 33.3, P = .029, respectively). Similar findings were observed in the improvement of cTFC (20.3 ± 10.5 vs 13.5 ± 5.0, P = .003; 20.2 ± 7.4 vs 15.2 ± 5.2, P = .003, respectively) and percentage of TMPG 3 (100% vs 82.8%, P = .052; 83.3% vs 96.7%, P = .196, respectively); whereas, nitroglycerin produced a limited effect on TMPFC (114.4 ± 30.9 vs 112.1 ± 31.9, P = .739), cTFC (19.4 ± 7.2 vs 19.3 ± 7.2, P = .936), and percentage of TMPG 3 (86.7% vs 86.7%, P = 1.000). No significant difference was found in the incidence of PMI (16.7% vs 16.0% vs 27.6%, P = .537), though it was comparatively lower in the nicorandil and alprostadil groups. Furthermore, the intracoronary administration of nicorandil and alprostadil had a mild effect on blood pressure and heart rate. CONCLUSIONS The intracoronary administration of nicorandil and alprostadil via a targeted perfusion microcatheter was more effective in improving myocardial perfusion in patients undergoing elective PCI than nitroglycerin.",2021,"Both nicorandil and alprostadil were significantly effective in reducing TMPFC (114.6 ± 33.7 vs 93.4 ± 30.9, P = .016; 114.3 ± 34.3 vs 94.7 ± 33.3, P = .029, respectively).","['patients undergoing elective PCI than', 'patients undergoing elective percutaneous coronary intervention (PCI', '90 consecutive patients scheduled for elective PCI for de novo coronary lesions', 'patients undergoing elective percutaneous coronary intervention']","['nicorandil', 'nicorandil, alprostadil, and nitroglycerin', 'nicorandil and alprostadil via targeted perfusion microcatheter', 'nicorandil and alprostadil', 'nitroglycerin']","['TMPFC', 'cTFC', 'thrombolysis in myocardial infarction (TIMI) myocardial perfusion frame count (TMPFC', 'myocardial perfusion', 'corrected TIMI frame count (cTFC), TIMI myocardial perfusion grade (TMPG), and incidence of periprocedural myocardial injury (PMI', 'Myocardial protective effect', 'incidence of PMI', 'blood pressure and heart rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0068700', 'cui_str': 'Nicorandil'}, {'cui': 'C0002335', 'cui_str': 'Alprostadil'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]","[{'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",90.0,0.18323,"Both nicorandil and alprostadil were significantly effective in reducing TMPFC (114.6 ± 33.7 vs 93.4 ± 30.9, P = .016; 114.3 ± 34.3 vs 94.7 ± 33.3, P = .029, respectively).","[{'ForeName': 'Weifeng', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiao Tong University.'}, {'ForeName': 'Jinjie', 'Initials': 'J', 'LastName': 'Dai', 'Affiliation': 'Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiao Tong University.'}, {'ForeName': 'Xiaowen', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiao Tong University.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiao Tong University.'}, {'ForeName': 'Xiaoxiao', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiao Tong University.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiao Tong University.'}, {'ForeName': 'Xiaolei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiao Tong University.'}, {'ForeName': 'Ziyong', 'Initials': 'Z', 'LastName': 'Hao', 'Affiliation': 'Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiao Tong University.'}, {'ForeName': 'Xingbiao', 'Initials': 'X', 'LastName': 'Qiu', 'Affiliation': 'Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiao Tong University.'}, {'ForeName': 'Lisheng', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiao Tong University.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiao Tong University.'}, {'ForeName': 'Linghong', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiao Tong University.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiao Tong University.'}]",Medicine,['10.1097/MD.0000000000025551'] 3629,33847663,"Prophylactically injection of Nicorandil to reduce no-reflow phenomenon during PCI in acute STEMI patients: Protocol of a double-blinded, randomized, placebo-controlled trial.","INTRODUCTION An acute ST-elevation myocardial infarction (STEMI) is a very serious type of heart attack and a profoundly life-threatening medical emergency, and percutaneous coronary intervention (PCI) is the preferred strategy. However, in patients undergoing primary PCI, 30% to 40% may suffer the no-reflow phenomenon (NRP), and it could expand the myocardial infarction area and accompanied with high rehospitalization rate and fatality rate. In this study, we try to conduct a double blinded, randomized, placebo-controlled trial to observe whether the prophylactically intracoronary administration of Nicorandil could reduce the occurrence of NRP in STEMI patients undergoing PCI. METHODS Simple randomization in a 1:1 ratio will be made in blocks of variable size according to a random numbers generated by Excel 2010 to divide the patients to treatment group (Nicorandil) and control group (Saline). The outcomes are the occurrence of NRP, levels of interleukin-6 and HS-CRP, cTnT, and CK-MB before, and every 4 hours following PCI, and major adverse cardiovascular events at day 30. SPSS 23.0 (IBM, Chicago, IL) will be used, and P-value < .05 will be considered statistically significant. CONCLUSIONS The findings will determine the efficacy of prophylactically intracoronary administration of Nicorandil to reduce the occurrence of NRP during PCI in acute STEMI patients. TRIAL REGISTRATION OSF Registration number: DOI 10.17605/OSF.IO/QPF3V.",2021,"The outcomes are the occurrence of NRP, levels of interleukin-6 and HS-CRP, cTnT, and CK-MB before, and every 4 hours following PCI, and major adverse cardiovascular events at day 30.","['OSF Registration number', 'acute STEMI patients']","['placebo', 'treatment group (Nicorandil) and control group (Saline', 'Nicorandil']","['rehospitalization rate and fatality rate', 'DOI 10.17605/OSF.IO/QPF3V', 'occurrence of NRP, levels of interleukin-6 and HS-CRP, cTnT, and CK-MB before, and every 4\u200ahours following PCI, and major adverse cardiovascular events']","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0068700', 'cui_str': 'Nicorandil'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0232347', 'cui_str': 'No reflow vascular flow'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C3538889', 'cui_str': 'Cardiac troponin T'}, {'cui': 'C0010290', 'cui_str': 'Creatine kinase isoenzyme, MB fraction'}, {'cui': 'C0585324', 'cui_str': 'Every four hours'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.763276,"The outcomes are the occurrence of NRP, levels of interleukin-6 and HS-CRP, cTnT, and CK-MB before, and every 4 hours following PCI, and major adverse cardiovascular events at day 30.","[{'ForeName': 'Su', 'Initials': 'S', 'LastName': 'An', 'Affiliation': ""Chongqing Dazu District People's Hospital, Chongqing, China.""}, {'ForeName': 'Huopeng', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Huaying', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Yunlu', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000025500'] 3630,33847642,"Nomogram for predicting the survival of patients with small cell carcinoma of the esophagus: A population study based on the surveillance, epidemiology, and end results database.","ABSTRACT This study aims to establish an effective prognostic nomogram for small cell carcinoma of the esophagus (SCCE).A total of 552 patients with SCCE from 1975 to 2016 were extracted from the surveillance, epidemiology, and end results (SEER) database. A Cox proportional hazard regression model was used to analyze the prognostic factors of patients, and a nomogram was constructed. The nomogram was then validated internally by using a consistency index (C-index) and a correction curve to evaluate its predictive value.The Cox proportional hazard regression model showed that age, stage, surgery, primary site, radiotherapy, and chemotherapy were the prognostic factors of SCCE (P < .1), and they were used to construct the nomogram. The C-index of the nomogram for predicting survival was 0.749 (95% confidence interval [CI] = 0.722-0.776). The data were randomly divided into a modeling group and a validation group based on 7:3 for internal validation. The C-indices of the modeling and validation groups were 0.753 and 0.725, respectively, and they were close to 0.749. The calibration curves exhibited good consistency between the predicted and actual survival rates.The nomogram of the survival and prognosis of patients with SCCE in this study had a good predictive value and could provide clinicians with accurate and practical predictive tools. It could also be used to facilitate a rapid and accurate assessment of patients' survival and prognosis on an individual basis.",2021,The C-index of the nomogram for predicting survival was 0.749,"['small cell carcinoma of the esophagus (SCCE).A total of 552 patients with SCCE from 1975 to 2016 were extracted from the surveillance, epidemiology, and end results (SEER) database', 'patients with small cell carcinoma of the esophagus']",[],['actual survival rates'],"[{'cui': 'C1112474', 'cui_str': 'Small cell carcinoma of esophagus'}, {'cui': 'C0149925', 'cui_str': 'Small cell carcinoma of lung'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]",[],"[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",552.0,0.0381694,The C-index of the nomogram for predicting survival was 0.749,"[{'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Qie', 'Affiliation': 'Department of Radiation Oncology, Affiliated Hospital of Hebei University, Baoding, PR China.'}, {'ForeName': 'Xue-Feng', 'Initials': 'XF', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Yu-Ge', 'Initials': 'YG', 'LastName': 'Ran', 'Affiliation': ''}, {'ForeName': 'Miao-Ling', 'Initials': 'ML', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Gui-Min', 'Initials': 'GM', 'LastName': 'Cui', 'Affiliation': ''}, {'ForeName': 'Hong-Yun', 'Initials': 'HY', 'LastName': 'Shi', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000025427'] 3631,33847614,Use of Shenhuang paste on Shenque point improves chemotherapy induced gastrointestinal toxicity in breast cancer: A protocol for randomized controlled trial.,"BACKGROUND Breast cancer, a malignant disorder, occurs in the epithelial tissue of the breast gland. Chemotherapy is the standard treatment for breast cancer, however, the side effect, especially gastrointestinal dysfunction, due to chemotherapy still remain major problems. Traditional Chinese Medicine has been proven therapeutically effective on reducing adverse effects caused by chemotherapy. Shenhuang Plaster. METHODS The study is a randomized, placebo-controlled, blind trial. A total of 160 Chinese breast cancer patients will be enrolled and randomly allocated into the experimental group and control group in a 1:1 ratio. Patients in the experimental group will be prescribed Shenhuang plaster application on shenque point (CV8) plus chemotherapy treatment. Patients in the control group will be prescribed placebo plaster application on CV8 plus chemotherapy treatment. The acupoint application will last 3 days. The primary outcome will be the form of faces every day, and the secondary outcomes the symptom score of traditional Chinese medicine, the changes of fecal bacteria and metabolites, serum motilin, gastrin and ghrelin levels. DISCUSSION This study is to observe therapeutic effects with Shenhuang plaster application on CV8 to regulate chemotherapy-induced gastrointestinal toxicity in breast cancer patients. TRIAL REGISTRATION Chinese Clinical Trial Registry (http://www.chictr.org.cn/showproj.aspx?proj=55262) No. ChiCTR2000034313. Registered on July 2, 2020.",2021,"Chemotherapy is the standard treatment for breast cancer, however, the side effect, especially gastrointestinal dysfunction, due to chemotherapy still remain major problems.","['breast cancer patients', '160 Chinese breast cancer patients', 'breast cancer']","['Shenhuang paste', 'placebo plaster application', 'placebo', 'Chemotherapy', 'Shenhuang plaster application on shenque point (CV8) plus chemotherapy treatment']","['adverse effects', 'gastrointestinal toxicity', 'symptom score of traditional Chinese medicine, the changes of fecal bacteria and metabolites, serum motilin, gastrin and ghrelin levels']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0030634', 'cui_str': 'Pastes'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0460977', 'cui_str': 'Plasters'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0026594', 'cui_str': 'Motilin'}, {'cui': 'C0017151', 'cui_str': 'Gastrins'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",160.0,0.125233,"Chemotherapy is the standard treatment for breast cancer, however, the side effect, especially gastrointestinal dysfunction, due to chemotherapy still remain major problems.","[{'ForeName': 'Rongyun', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Zhejiang Chinese Medical University.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'School of Nursing, Zhejiang Chinese Medical University.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'Zhejiang Provincial Hospital of Chinese Medicine.'}, {'ForeName': 'Qinling', 'Initials': 'Q', 'LastName': 'Ge', 'Affiliation': 'Zhejiang Provincial Hospital of Chinese Medicine.'}, {'ForeName': 'Jingming', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'The First College of Clinical Medicine, Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Qiuhua', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': 'School of Nursing, Zhejiang Chinese Medical University.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Zhejiang Provincial Hospital of Chinese Medicine.'}]",Medicine,['10.1097/MD.0000000000025097'] 3632,33847588,A Home-Based Mobile Health Intervention to Replace Sedentary Time With Light Physical Activity in Older Cancer Survivors: Randomized Controlled Pilot Trial.,"BACKGROUND Older cancer survivors are at risk of the development or worsening of both age- and treatment-related morbidity. Sedentary behavior increases the risk of or exacerbates these chronic conditions. Light-intensity physical activity (LPA) is more common in older adults and is associated with better health and well-being. Thus, replacing sedentary time with LPA may provide a more successful strategy to reduce sedentary time and increase physical activity. OBJECTIVE This study primarily aims to evaluate the feasibility, acceptability, and preliminary efficacy of a home-based mobile health (mHealth) intervention to interrupt and replace sedentary time with LPA (standing and stepping). The secondary objective of this study is to examine changes in objective measures of physical activity, physical performance, and self-reported quality of life. METHODS Overall, 54 cancer survivors (aged 60-84 years) were randomized in a 1:1:1 allocation to the tech support intervention group, tech support plus health coaching intervention group, or waitlist control group. Intervention participants received a Jawbone UP2 activity monitor for use with their smartphone app for 13 weeks. Tech support and health coaching were provided via 5 telephone calls during the 13-week intervention. Sedentary behavior and physical activity were objectively measured using an activPAL monitor for 7 days before and after the intervention. RESULTS Participants included survivors of breast cancer (21/54, 39%), prostate cancer (16/54, 30%), and a variety of other cancer types; a mean of 4.4 years (SD 1.6) had passed since their cancer diagnosis. Participants, on average, were 70 years old (SD 4.8), 55% (30/54) female, 24% (13/54) Hispanic, and 81% (44/54) overweight or obese. Malfunction of the Jawbone trackers occurred in one-third of the intervention group, resulting in enrollment stopping at 54 rather than the initial goal of 60 participants. Despite these technical issues, the retention in the intervention was high (47/54, 87%). Adherence was high for wearing the tracker (29/29, 100%) and checking the app daily (28/29, 96%) but low for specific aspects related to the sedentary features of the tracker and app (21%-25%). The acceptability of the intervention was moderately high (81%). There were no significant between-group differences in total sedentary time, number of breaks, or number of prolonged sedentary bouts. There were no significant between-group differences in physical activity. The only significant within-group change occurred within the health coaching group, which increased by 1675 daily steps (95% CI 444-2906; P=.009). This increase was caused by moderate-intensity stepping rather than light-intensity stepping (+15.2 minutes per day; 95% CI 4.1-26.2; P=.008). CONCLUSIONS A home-based mHealth program to disrupt and replace sedentary time with stepping was feasible among and acceptable to older cancer survivors. Future studies are needed to evaluate the optimal approach for replacing sedentary behavior with standing and/or physical activity in this population. TRIAL REGISTRATION ClinicalTrials.gov NCT03632694; https://clinicaltrials.gov/ct2/show/NCT03632694.",2021,"There were no significant between-group differences in total sedentary time, number of breaks, or number of prolonged sedentary bouts.","['54 cancer survivors (aged 60-84 years', 'older adults', 'Older Cancer Survivors', 'older cancer survivors', 'Older cancer survivors', 'Participants included survivors of breast cancer (21/54, 39%), prostate cancer (16/54, 30%), and a variety of other cancer types; a mean of 4.4 years (SD 1.6) had passed since their cancer diagnosis', 'Participants, on average, were 70 years old (SD 4.8), 55% (30/54) female, 24% (13/54) Hispanic, and 81% (44/54) overweight or obese']","['Home-Based Mobile Health Intervention to Replace Sedentary Time', 'home-based mobile health (mHealth) intervention', 'tech support intervention group, tech support plus health coaching intervention group, or waitlist control group', 'LPA (standing and stepping', 'Jawbone UP2 activity monitor', 'Light-intensity physical activity (LPA']","['Jawbone trackers', 'Adherence', 'total sedentary time, number of breaks, or number of prolonged sedentary bouts', 'physical activity, physical performance, and self-reported quality of life', 'Sedentary behavior and physical activity', 'physical activity', 'moderate-intensity stepping rather than light-intensity stepping']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4517765', 'cui_str': '4.8'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1096202', 'cui_str': 'Lipoprotein (a) measurement'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0445131', 'cui_str': 'Number of breaks'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}]",60.0,0.0589799,"There were no significant between-group differences in total sedentary time, number of breaks, or number of prolonged sedentary bouts.","[{'ForeName': 'Cindy K', 'Initials': 'CK', 'LastName': 'Blair', 'Affiliation': 'Department of Internal Medicine, University of New Mexico, Albuquerque, NM, United States.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Harding', 'Affiliation': 'Department of Internal Medicine, University of New Mexico, Albuquerque, NM, United States.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Wiggins', 'Affiliation': 'Department of Internal Medicine, University of New Mexico, Albuquerque, NM, United States.'}, {'ForeName': 'Huining', 'Initials': 'H', 'LastName': 'Kang', 'Affiliation': 'Department of Internal Medicine, University of New Mexico, Albuquerque, NM, United States.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Schwartz', 'Affiliation': 'Department of Internal Medicine, University of New Mexico, Albuquerque, NM, United States.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Tarnower', 'Affiliation': 'Department of Internal Medicine, University of New Mexico, Albuquerque, NM, United States.'}, {'ForeName': 'Ruofei', 'Initials': 'R', 'LastName': 'Du', 'Affiliation': 'University of New Mexico Comprehensive Cancer Center, Albuquerque, NM, United States.'}, {'ForeName': 'Anita Y', 'Initials': 'AY', 'LastName': 'Kinney', 'Affiliation': 'School of Public Health, Rutgers University, Piscataway, NJ, United States.'}]",JMIR cancer,['10.2196/18819'] 3633,33847582,Aponeurotic release of semimembranosus: A technical note to increase correction gained with hamstring lengthening surgery in cerebral palsy.,"OBJECTIVE The aim of this study was to determine the intraoperative corrective effect of the aponeurotic release of semimembranosus (SM) as a single procedure or an adjunct procedure to distal myotendinous release of semitendinosus (ST) and myofascial release of SM lengthening in the correction of knee flexion deformity in cerebral palsy (CP). METHODS In this prospective study, 46 knees of 23 consecutive ambulatory patients (15 boys and 8 girls; mean age=8.33 years; age range=5-12 years) with spastic diplegic CP with a gross motor function classification system level (GMFCS) II or III were included. The patients were then divided into 2 groups. In group I, there were 10 patients (4 boys, 6 girls; mean age=8.6±2), and combined release of ST in the myotendinous junction and SM in the myofascial junction, followed by aponeurotic release of SM were carried out. In group II, there were 13 patients (2 girls, 11 boys; mean age=8±2.35), and aponeurotic release of SM was done first and followed by the combined release of ST in the distal myotendinous junction and the myofascial release of SM. Intraoperative popliteal angle (PA) measurements were recorded in each group. RESULTS PA was reduced from 58.1°±7.6° (range=46°-75°) to 41.2°±8.8° (range=20°-54°) in group 1 and from 59.1°±11.3° (range=40°-87°) to 42.7°±10.8° (range=24°-64°) in group 2. No significant difference was observed between the groups in terms of reduction in PA (p=0.867). In group 1, adding the aponeurotic release of SM further reduced the PA to 31.7°± 8.5° (range=14°-47°) (p=0.002). In group 2, adding the myotendinous release of ST and myofascial release of SM further reduced the PA to 32.9°±7.2° (range=16°-44°) (p=0.004). There was no significant difference between the final PA values in the 2 groups (p=0.662). There was no difference in terms of early complications. CONCLUSION Aponeurotic release of SM is equally effective to reduce the intraoperative PA with combined myotendinous release of ST and myofascial release of SM. Combining all the 3 procedures provides a better correction without forceful manipulation or lengthening of the lateral hamstrings during the correction of knee flexion deformity in CP.",2021,"RESULTS PA was reduced from 58.1°±7.6° (range=46°-75","['°) in group 1 and from 59.1°±11.3° ', 'cerebral palsy', 'cerebral palsy (CP', '46 knees of 23 consecutive ambulatory patients (15 boys and 8 girls; mean age=8.33 years; age range=5-12 years) with spastic diplegic CP with a gross motor function classification system level (GMFCS) II or III were included']","['SM lengthening', 'semimembranosus (SM', 'hamstring lengthening surgery']","['myofascial release of SM', 'aponeurotic release of SM', 'ST and myofascial release of SM', 'Intraoperative popliteal angle (PA) measurements', 'final PA values', 'early complications']","[{'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0023882', 'cui_str': 'Spastic diplegia'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0224452', 'cui_str': 'Semimembranosus muscle structure'}, {'cui': 'C0441592', 'cui_str': 'Surgical lengthening - action'}, {'cui': 'C0392744', 'cui_str': 'Lengthened'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0695600', 'cui_str': 'Myofascial release'}, {'cui': 'C0224452', 'cui_str': 'Semimembranosus muscle structure'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0224453', 'cui_str': 'Semitendinosus muscle structure'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0442037', 'cui_str': 'Popliteal'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0231243', 'cui_str': 'Early complication'}]",23.0,0.0117567,"RESULTS PA was reduced from 58.1°±7.6° (range=46°-75","[{'ForeName': 'Şenol', 'Initials': 'Ş', 'LastName': 'Bekmez', 'Affiliation': 'Clinic of Orthopaedics and Traumatology, Çankaya Hospital, Ankara, Turkey.'}, {'ForeName': 'Alper', 'Initials': 'A', 'LastName': 'Yatağanbaba', 'Affiliation': 'Department of Orthopaedics and Traumatology, Hacettepe University, School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Güney', 'Initials': 'G', 'LastName': 'Yılmaz', 'Affiliation': 'Department of Orthopaedics and Traumatology, Hacettepe University, School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Uğur', 'Initials': 'U', 'LastName': 'Gonç', 'Affiliation': 'Clinic of Orthopaedics and Traumatology, Çankaya Hospital, Ankara, Turkey.'}, {'ForeName': 'Tuna', 'Initials': 'T', 'LastName': 'Karahan', 'Affiliation': 'Department of Anatomy, Ankara University, School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Muharrem', 'Initials': 'M', 'LastName': 'Yazıcı', 'Affiliation': 'Department of Orthopaedics and Traumatology, Hacettepe University, School of Medicine, Ankara, Turkey.'}]",Acta orthopaedica et traumatologica turcica,['10.5152/j.aott.2021.20184'] 3634,33847575,Comparison of efficacy between the genicular nerve block and the popliteal artery and the capsule of the posterior knee (IPACK) block for total knee replacement surgery: A prospective randomized controlled study.,"OBJECTIVE The aim of this study was to compare the efficacy of popliteal artery and the capsule of the posterior knee (IPACK) block and genicular nerve block on postoperative pain scores, the need for rescue analgesics, range of motion (ROM), walking distance, and perioperative monitorization variables in patients undergoing total knee replacement (TKR) surgery. METHODS Sixty American Society of Anesthesiologists (ASA) physical status I-III patients were enrolled in this study and then were randomly assigned into three groups: the IPACK block group (17 female, 3 male; mean age=67.5±1.4 years), genicular nerve block (16 female, 4 male; mean age=68±1.76 years), and the control group (13 female, 7 male; mean age=63±1.67years). All the patients underwent TKR under spinal anesthesia. The visual analog scale (VAS) score, mobility, pre- and intra-operative monitorization of systolic and diastolic holding area, non-invasive blood pressure, heart rate, and SPO 2 were compared between the groups. RESULTS Patients in the IPACK and genicular block groups had a significantly lower visual analogous scale (VAS) at postoperative 4 hours (p<0.01), 8h (p<0.01), 12h (p<0.01), and 24h (p<0.05). VAS score was significantly lower in the genicular block group at the postoperative 4h (5.5±0.55) and 8h (5.0±0.53) in the mobile state compared to the IPACK (8.0±0.47 and 8.0±0.43, respectively) and the control group (9.5±0.20; 10±0.28, respectively) (p< 0.01). The use of patient-controlled-analgesia (PCA) devices and button push count for analgesics demand were significantly lower in the genicular block group on the immediate postoperative period (p<0.01 at the postoperative 0 to 4 h). The total consumption of morphine equivalents on the postoperative day 0 was significantly lower in the genicular block group (p<0.01, and p<0.001 for IPACK and control groups, respectively). The degree of flexion was significantly higher in the genicular block group at the postoperative 12h compared to the IPACK and the control group (p<0.001). The length of hospital stay was significantly lower in the genicular block group compared to the IPACK and the control group (p<0.05 for both variables). CONCLUSION IPACK and genicular blocks both are effective in improving patient comfort during and after TKR surgery and reducing the potential need for systemic analgesic and opioids. The genicular block seems to be a promising technique that can offer improved pain management in the immediate and early postoperative period without adverse effects on systemic and motor variables.",2021,"The length of hospital stay was significantly lower in the genicular block group compared to the IPACK and the control group (p<0.05 for both variables). ","['Sixty American Society of Anesthesiologists (ASA) physical status', 'total knee replacement surgery', 'patients underwent TKR under spinal anesthesia', 'patients undergoing total knee replacement (TKR) surgery', 'group (17 female, 3 male; mean age=67.5±1.4 years), genicular nerve block (16 female, 4 male; mean age=68±1.76 years), and the control group (13 female, 7 male; mean age=63±1.67years']","['IPACK block', 'genicular nerve block and the popliteal artery and the capsule of the posterior knee (IPACK) block', 'popliteal artery and the capsule of the posterior knee (IPACK) block and genicular nerve block']","['total consumption of morphine equivalents', 'VAS score', 'visual analogous scale (VAS', 'degree of flexion', 'visual analog scale (VAS) score, mobility, pre- and intra-operative monitorization of systolic and diastolic holding area, non-invasive blood pressure, heart rate, and SPO 2', 'postoperative pain scores, the need for rescue analgesics, range of motion (ROM), walking distance, and perioperative monitorization variables', 'length of hospital stay']","[{'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0032649', 'cui_str': 'Structure of popliteal artery'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C4301970', 'cui_str': 'Non-invasive blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",60.0,0.0331786,"The length of hospital stay was significantly lower in the genicular block group compared to the IPACK and the control group (p<0.05 for both variables). ","[{'ForeName': 'Selcan', 'Initials': 'S', 'LastName': 'Akesen', 'Affiliation': 'Department of Anesthesiology and Reanimation, Uludağ University, School of Medicine, Bursa, Turkey.'}, {'ForeName': 'Burak', 'Initials': 'B', 'LastName': 'Akesen', 'Affiliation': 'Department of Orthopedics and Traumatology, Uludağ University, School of Medicine, Bursa, Turkey.'}, {'ForeName': 'Teoman', 'Initials': 'T', 'LastName': 'Atıcı', 'Affiliation': 'Department of Orthopedics and Traumatology, Uludağ University, School of Medicine, Bursa, Turkey.'}, {'ForeName': 'Alp', 'Initials': 'A', 'LastName': 'Gurbet', 'Affiliation': 'Department of Anesthesiology and Reanimation, Uludağ University, School of Medicine, Bursa, Turkey.'}, {'ForeName': 'Cenk', 'Initials': 'C', 'LastName': 'Ermutlu', 'Affiliation': 'Department of Orthopedics and Traumatology, Uludağ University, School of Medicine, Bursa, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Özyalçın', 'Affiliation': 'Department of Orthopedics and Traumatology, Uludağ University, School of Medicine, Bursa, Turkey.'}]",Acta orthopaedica et traumatologica turcica,['10.5152/j.aott.2021.20187'] 3635,33847470,Are individuals with orofacial pain more prone to psychological distress during the COVID-19 pandemic?,"BACKGROUND It is of utmost importance to identify and treat groups susceptible to psychological problems during the coronavirus disease 2019 (COVID-19) pandemic. OBJECTIVES This study aimed to compare the psychological status between the general population and subjects with orofacial pain (OFP) during the COVID-19 pandemic. MATERIAL AND METHODS A total of 509 young adults were recruited based on the inclusion and exclusion criteria, using the convenient sampling approach. They were assigned to 2 study groups: group 1 - individuals with OFP; and group 2 - the general population. Their background variables, knowledge, perception, attitude, concerns, and Kessler scale scores were recorded through an online questionnaire. Student's t test, the χ2 test, Pearson's correlation coefficient, and one-way analysis of variance (ANOVA) were used for the statistical analysis. RESULTS Some of the background variables were significantly different between the study groups (p < 0.05). The knowledge, perception and attitude scores of the respondents were not significantly different between the study groups (p > 0.05). Females exhibited significantly higher adjusted Kessler scores as compared to males (p < 0.05). Group 1 exhibited the highest adjusted Kessler scores (p < 0.05). CONCLUSIONS Individuals with OFP exhibited higher psychological distress, depressive symptoms and anxiety during the rapid rise of the COVID-19 outbreak, representing a moderate psychological disorder. Females suffered more from psychological distress as compared to males. Therefore, psychological interventions should be focused on this group.",2021,"The knowledge, perception and attitude scores of the respondents were not significantly different between the study groups (p > 0.05).","['general population and subjects with orofacial pain (OFP) during the COVID-19 pandemic', '509 young adults']",['OFP'],"['psychological distress, depressive symptoms and anxiety', 'adjusted Kessler scores', 'knowledge, perception and attitude scores', 'psychological distress', 'knowledge, perception, attitude, concerns, and Kessler scale scores', 'highest adjusted Kessler scores']","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0178782', 'cui_str': 'Orofacial Pain'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0178782', 'cui_str': 'Orofacial Pain'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205250', 'cui_str': 'High'}]",509.0,0.0614942,"The knowledge, perception and attitude scores of the respondents were not significantly different between the study groups (p > 0.05).","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Saki', 'Affiliation': 'Health System Research Center, Shiraz University of Medical Sciences, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Shadmanpour', 'Affiliation': 'Orthodontic Research Center, Department of Orthodontics, School of Dentistry, Shiraz University of Medical Sciences, Iran.'}, {'ForeName': 'Hooman Zarif', 'Initials': 'HZ', 'LastName': 'Najafi', 'Affiliation': 'Orthodontic Research Center, Department of Orthodontics, School of Dentistry, Shiraz University of Medical Sciences, Iran.'}]",Dental and medical problems,['10.17219/dmp/131683'] 3636,33843376,Effects of exercise training on immunological factors in kidney transplant recipients; a randomized controlled trial.,"The purpose of this study was to investigate the effects of a 12 week exercise training on the immune system of kidney transplant recipients. 23 kidney transplant recipients were randomly divided into two groups including control (n = 10) and training (n =13) groups. The training groups participated in the training for 10 weeks (three days a week; each day 60-90 minutes). The control group performed no regular exercise during this time. The blood samples were taken before and after 12 weeks. ELISA and Real-time PCR were used to evaluate cytokine profiles, including TNF-a, IL-6, IL-4, IL-31 and IL-35 as well as T-bet, GATA-3, RORYt and FOXP3, respectively. Finally, the data were analyzed, using paired T-test. ELISA results showed decreased levels of TNF- α, increased levels of IL-6 and no significant differences in the IL-35, IL-31 and IL-4 levels in the training group in comparison to the control group. Gene expression profiles showed significantly increased expression of T-bet and no changes in the GATA-3, RORYt and FOXP3 levels. According to these results, a moderate exercise including aerobic and resistance training could inhibit inflammatory cytokines and have beneficial effects on the immune system, but this issue needs further research.",2021,"Gene expression profiles showed significantly increased expression of T-bet and no changes in the GATA-3, RORYt and FOXP3 levels.","['23 kidney transplant recipients', 'kidney transplant recipients']","['control group performed no regular exercise', 'exercise training']","['ELISA and Real-time PCR', 'immunological factors', 'levels of TNF- α, increased levels of IL-6', 'cytokine profiles, including TNF-a, IL-6, IL-4, IL-31 and IL-35', 'expression of T-bet and no changes in the GATA-3, RORYt and FOXP3 levels', 'IL-35, IL-31 and IL-4 levels']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0021054', 'cui_str': 'Immunologic substance'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1448177', 'cui_str': 'TNF protein, human'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C1571097', 'cui_str': 'IL31 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0442739', 'cui_str': 'No status change'}, {'cui': 'C1307598', 'cui_str': 'GATA3 protein, human'}]",,0.0108421,"Gene expression profiles showed significantly increased expression of T-bet and no changes in the GATA-3, RORYt and FOXP3 levels.","[{'ForeName': 'Nazi', 'Initials': 'N', 'LastName': 'Hemmati', 'Affiliation': 'Department of Sport Sciences, Shiraz University, Shiraz, Iran.'}, {'ForeName': 'Sohrab', 'Initials': 'S', 'LastName': 'Kazemi', 'Affiliation': 'Department of Sport Sciences, Shiraz University, Shiraz, Iran.'}, {'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Jamshidian-Tehrani', 'Affiliation': 'Organ Transplant Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Jamshid', 'Initials': 'J', 'LastName': 'Roozbeh', 'Affiliation': 'Shiraz Nephro-Urology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Koushkie Jahromi', 'Affiliation': 'Department of Sport Sciences, Shiraz University, Shiraz, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Salesi', 'Affiliation': 'Department of Sport Sciences, Shiraz University, Shiraz, Iran.'}, {'ForeName': 'Meghdad', 'Initials': 'M', 'LastName': 'Abdollahpour-Alitappeh', 'Affiliation': 'Cellular and Molecular Biology Research Center, Larestan University of Medical Sciences, Larestan, Iran.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Karimi', 'Affiliation': 'Transplant Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Research in sports medicine (Print),['10.1080/15438627.2021.1906671'] 3637,33843133,Phase III randomized trial evaluating chemotherapy followed by pelvic re-irradiation versus chemotherapy alone as pre-operative treatment for locally recurrent rectal cancer - GRECCAR 15 Trial Protocol.,"AIM Treatment strategies in locally recurrent rectal cancer (LRRC) are complex and need to be balanced against previous treatments received for the primary rectal cancer. Radiotherapy is an important component of treatment in LRRC. However, there is little high quality evidence on the role of re-irradiation in this cohort. METHODS GRECCAR 15 is a prospective, multi-centre, open-label, outcome assessor blinded, superiority randomized controlled phase III clinical trial, comparing neoadjuvant chemotherapy followed by pelvic re-irradiation versus neoadjuvant chemotherapy alone in patients with LRRC previously irradiated for the primary cancer. Adult patients (>18 years old) with a histologically proven, resectable LRRC, who previously have received pelvic radiotherapy for their primary rectal cancer at a dose of 25-50.4 Gy, and an Eastern Cooperative Oncology Group (ECOG) performance status of <2 will be eligible to participate. The primary outcome of this trial is R0 resection rate. Overall, GRECCAR 15 aims to recruit 186 patients to detect an absolute difference of 20 % in the R0 resection rate with 80% power and 5% 2-sided significance level. CONCLUSION GRECCAR 15 trial is the first, definitive, phase III trial investigating re-irradiation in LRRC. The results of this trial will inform definitively the neoadjuvant treatment strategy in previously irradiated patients and assess whether there is any associated benefit of re-irradiation in combination with induction chemotherapy in improving R0 resection rates.",2021,The results of this trial will inform definitively the neoadjuvant treatment strategy in previously irradiated patients and assess whether there is any associated benefit of re-irradiation in combination with induction chemotherapy in improving R0 resection rates.,"['patients with LRRC previously irradiated for the primary cancer', 'Adult patients (>18 years old) with a histologically proven, resectable LRRC, who previously have received', 'for their primary rectal cancer at a dose of 25-50.4 Gy, and an Eastern Cooperative Oncology Group (ECOG) performance status of <2 will be eligible to participate', 'locally recurrent rectal cancer - GRECCAR 15 Trial Protocol', 'locally recurrent rectal cancer (LRRC']","['chemotherapy followed by pelvic re-irradiation versus chemotherapy alone', 'Radiotherapy', 'neoadjuvant chemotherapy followed by pelvic re-irradiation versus neoadjuvant chemotherapy alone', 'pelvic radiotherapy']",['R0 resection rate'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278554', 'cui_str': 'Rectal cancer recurrent'}, {'cui': 'C1277077', 'cui_str': 'Irradiated blood product'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C4042794', 'cui_str': 'Re Irradiation'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}]","[{'cui': 'C0015252', 'cui_str': 'Removal'}]",,0.447667,The results of this trial will inform definitively the neoadjuvant treatment strategy in previously irradiated patients and assess whether there is any associated benefit of re-irradiation in combination with induction chemotherapy in improving R0 resection rates.,"[{'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Denost', 'Affiliation': 'Département de Chirurgie Colorectal, Hôpital Haut-Lévèque, 1 avenue Magellan, 33604, Pessac CHU Bordeaux, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Frison', 'Affiliation': ""Inserm, CIC1401-EC, Bordeaux; CHU Bordeaux, Service d'information médicale, 146 rue Léo Saignat, F-33076, Bordeaux, France.""}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Salut', 'Affiliation': 'Service de Radiologie, Hôpital Haut-Lévèque, 1 avenue Magellan, 33600, Pessac CHU Bordeaux, France.'}, {'ForeName': 'Remy', 'Initials': 'R', 'LastName': 'Sitta', 'Affiliation': ""Inserm, CIC1401-EC, Bordeaux; CHU Bordeaux, Service d'information médicale, 146 rue Léo Saignat, F-33076, Bordeaux, France.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Rullier', 'Affiliation': ""Anne Rullier, Service d'Anatomopathologie, Hôpital Pellegrin, place Amélie Rabat-Léon, 33076, Bordeaux CHU Bordeaux, France.""}, {'ForeName': 'Deena', 'Initials': 'D', 'LastName': 'Harji', 'Affiliation': 'Département de Chirurgie Colorectal, Hôpital Haut-Lévèque, 1 avenue Magellan, 33604, Pessac CHU Bordeaux, France.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Maillou-Martinaud', 'Affiliation': 'Département de Chirurgie Colorectal, Hôpital Haut-Lévèque, 1 avenue Magellan, 33604, Pessac CHU Bordeaux, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Rullier', 'Affiliation': 'Département de Chirurgie Colorectal, Hôpital Haut-Lévèque, 1 avenue Magellan, 33604, Pessac CHU Bordeaux, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': ""Service d'oncologie, Hôpital Haut-Lévèque, 1 avenue Magellan, 33600, Pessac CHU Bordeaux, France.""}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Vendrely', 'Affiliation': 'Radiotherapy Department, Haut-Lévèque Hospital, avenue Magellan, 33604, Pessac CHU Bordeaux, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.15670'] 3638,33842832,Adverse Events and Perception of Benefit From Duloxetine for Treating Aromatase Inhibitor-Associated Arthralgias.,"Background Duloxetine effectively treats aromatase inhibitor-associated musculoskeletal symptoms (AIMSS) in women with breast cancer but causes low-grade toxicities. This secondary analysis examines the relationship between adverse events (AE) and patient-perceived benefit, based on patient self-report that the treatment received was beneficial despite side effects. We hypothesized that duloxetine had a favorable effect on patient-perceived benefit, even among duloxetine-treated patients who experienced AEs and who, had they been treated with placebo, would have experienced none. Methods Principal stratification was used to estimate the effect of duloxetine vs placebo on patient-perceived benefit and Functional Assessment of Cancer Therapy-Endocrine Scale functional quality of life in the randomized, double-blind trial SWOG S1202 (n = 289). Subgroups of patients were defined by observed and counterfactual (what would have occurred had they been randomly assigned to the opposite study arm) experiences of AEs and the original primary outcome, reduction of average pain after 12 weeks of at least 2 points on the Brief Pain Inventory-Short Form. Results Duloxetine caused an estimated 23.4% (95% credible interval [CI] = 13.4% to 33.7%) of patients to experience an AE even though they would have experienced none on placebo. Those patients remained more likely to report that their received treatment was beneficial than comparable patients assigned placebo (73.3% vs 41.8%, respectively; 95% CI for difference = 15.4 to 47.2 percentage points), although there was no statistically significant effect of duloxetine on functional quality of life (11.3 vs 9.0, 95% CI for difference = -2.2 to +6.7). Conclusion Duloxetine resulted in higher patient-perceived benefit, even among those who would have an AE on duloxetine but none on placebo. Treatment of AIMSS with duloxetine should be considered for appropriate patients.",2021,Duloxetine caused an estimated 23.4% (95% credible interval [CI] = 13.4% to 33.7%) of patients to experience an AE even though they would have experienced none on placebo.,['women with breast cancer'],"['duloxetine vs placebo', 'duloxetine', 'Brief Pain Inventory-Short Form', 'placebo', 'Duloxetine']","['average pain', 'patient-perceived benefit and Functional Assessment of Cancer Therapy-Endocrine Scale functional quality of life', 'functional quality of life']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.544003,Duloxetine caused an estimated 23.4% (95% credible interval [CI] = 13.4% to 33.7%) of patients to experience an AE even though they would have experienced none on placebo.,"[{'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Schnell', 'Affiliation': 'Division of Biostatistics, The Ohio State University College of Public Health, Columbus, OH, USA.'}, {'ForeName': 'Maryam B', 'Initials': 'MB', 'LastName': 'Lustberg', 'Affiliation': 'Division of Internal Medicine, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'N Lynn', 'Initials': 'NL', 'LastName': 'Henry', 'Affiliation': 'Department of Internal Medicine, Division of Hematology/Oncology, University of Michigan Medical School, Ann Arbor, MI, USA.'}]",JNCI cancer spectrum,['10.1093/jncics/pkab018'] 3639,33840404,[Efficacy and safety of mycophenolate mofetil versus cyclophosphamide in the treatment of Henoch-Schönlein purpura nephritis with nephrotic-range proteinuria in children: a prospective randomized controlled trial].,"OBJECTIVE To study the efficacy and safety of mycophenolate mofetil (MMF) versus cyclophosphamide (CTX) in the treatment of children with Henoch-Schönlein purpura nephritis (HSPN) and nephrotic-range proteinuria. METHODS A prospective clinical trial was conducted in 68 pediatric patients who were admitted to the Department of Nephrology, Children's Hospital Affiliated to Capital Institute of Pediatrics and who were diagnosed with HSPN and nephrotic-range proteinuria from August 2016 to November 2019. The patients were randomly divided into two groups:MMF treatment ( n =33) and CTX treatment ( n =35). The two groups were compared in terms of complete remission rate, response rate (complete remission + partial remission), urinary protein clearance time, and adverse events. RESULTS At months 3, 6, and 12 of treatment, there was no significant difference in the complete remission rate and the response rate between the MMF treament and CTX treatment groups ( P > 0.05). There was also no significant difference between the two groups in the urinary protein clearance time and the incidence rate of adverse events ( P > 0.05). CONCLUSIONS MMF and CTX have similar efficacy and safety in the treatment of HSPN children with nephrotic-range proteinuria.",2021,"There was also no significant difference between the two groups in the urinary protein clearance time and the incidence rate of adverse events ( P > 0.05). ","[""68 pediatric patients who were admitted to the Department of Nephrology, Children's Hospital Affiliated to Capital Institute of Pediatrics and who were diagnosed with HSPN and nephrotic-range proteinuria from August 2016 to November 2019"", 'HSPN children with nephrotic-range proteinuria', 'children with Henoch-Schönlein purpura nephritis (HSPN) and nephrotic-range proteinuria', 'Henoch-Schönlein purpura nephritis with nephrotic-range proteinuria in children']","['mycophenolate mofetil (MMF) versus cyclophosphamide (CTX', 'mycophenolate mofetil versus cyclophosphamide', 'MMF and CTX', 'CTX treatment', 'MMF treatment']","['urinary protein clearance time and the incidence rate of adverse events', 'efficacy and safety', 'complete remission rate, response rate (complete remission + partial remission), urinary protein clearance time, and adverse events', 'response rate', 'complete remission rate']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0027712', 'cui_str': 'Nephrology'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C2721603', 'cui_str': 'Henoch-Schonlein purpura nephritis'}, {'cui': 'C0445118', 'cui_str': 'Nephrotic range proteinuria'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}]",68.0,0.0179417,"There was also no significant difference between the two groups in the urinary protein clearance time and the incidence rate of adverse events ( P > 0.05). ","[{'ForeName': 'Hai-Yun', 'Initials': 'HY', 'LastName': 'Geng', 'Affiliation': ""Department of Nephrology, Children's Hospital Affiliated to Capital Institute of Pediatrics, Beijing 100020, China.""}, {'ForeName': 'Chao-Ying', 'Initials': 'CY', 'LastName': 'Chen', 'Affiliation': ""Department of Nephrology, Children's Hospital Affiliated to Capital Institute of Pediatrics, Beijing 100020, China.""}, {'ForeName': 'Hua-Rong', 'Initials': 'HR', 'LastName': 'Li', 'Affiliation': ""Department of Nephrology, Children's Hospital Affiliated to Capital Institute of Pediatrics, Beijing 100020, China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Tu', 'Affiliation': ""Department of Nephrology, Children's Hospital Affiliated to Capital Institute of Pediatrics, Beijing 100020, China.""}, {'ForeName': 'Pei-Wei', 'Initials': 'PW', 'LastName': 'DU', 'Affiliation': ""Department of Nephrology, Children's Hospital Affiliated to Capital Institute of Pediatrics, Beijing 100020, China.""}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Xia', 'Affiliation': ""Department of Nephrology, Children's Hospital Affiliated to Capital Institute of Pediatrics, Beijing 100020, China.""}]",Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics,[] 3640,33840403,[Effect of delayed cord clamping and umbilical cord milking on cerebral hemodynamics in preterm infants: a randomized double-blind controlled trial].,"OBJECTIVE To compare the effect of delayed cord clamping (DCC) versus umbilical cord milking (UCM) on cerebral blood flow in preterm infants. METHODS This was a single-center, prospective, double-blind, randomized controlled trial. A total of 46 preterm infants, with a gestational age of 30-33 +6 weeks, who were born in Suining Central Hospital from November 2, 2018 to November 15, 2019 were enrolled and randomly divided into DCC group and UCM group, with 23 infants in each group. The primary outcome indexes included cerebral hemodynamic parameters[peak systolic velocity (PSV), end-diastolic velocity (EDV), and resistance index (RI)] measured by ultrasound within 0.5-1 hour, (24±1) hours, (48±1) hours, and (72±1) hours after birth. Secondary outcome indexes included hematocrit, hemoglobin, red blood cell count, and serum total bilirubin levels on the first day after birth and the incidence rate of intraventricular hemorrhage during hospitalization. RESULTS A total of 21 preterm infants in the DCC group and 23 in the UCM group were included in the statistical analysis. There was no significant difference in PSV, EDV, and RI between the two groups at all time points after birth ( P > 0.05). There was also no significant difference between the two groups in the hematocrit, hemoglobin, red blood cell count and total bilirubin levels on the first day after birth, and the incidence rate of intraventricular hemorrhage during hospitalization ( P > 0.05). CONCLUSIONS DCC and UCM have a similar effect on cerebral hemodynamics in preterm infants with a gestational age of 30-33 +6 weeks.",2021,"There was no significant difference in PSV, EDV, and RI between the two groups at all time points after birth ( P > 0.05).","['preterm infants with a gestational age of 30-33 +6 weeks', '46 preterm infants, with a gestational age of 30-33 +6 weeks, who were born in Suining Central Hospital from November 2, 2018 to November 15, 2019', '21 preterm infants in the DCC group and 23 in the UCM group', 'preterm infants']","['DCC and UCM', 'delayed cord clamping and umbilical cord milking', 'delayed cord clamping (DCC) versus umbilical cord milking (UCM', 'DCC group and UCM']","['cerebral hemodynamic parameters[peak systolic velocity (PSV), end-diastolic velocity (EDV), and resistance index (RI)] measured by ultrasound within 0.5-1 hour, (24±1) hours, (48±1) hours, and (72±1) hours after birth', 'hematocrit, hemoglobin, red blood cell count, and serum total bilirubin levels on the first day after birth and the incidence rate of intraventricular hemorrhage during hospitalization', 'incidence rate of intraventricular hemorrhage during hospitalization', 'hematocrit, hemoglobin, red blood cell count and total bilirubin levels', 'PSV, EDV, and RI', 'cerebral blood flow', 'cerebral hemodynamics']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}]","[{'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C1278039', 'cui_str': 'Serum total bilirubin measurement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0201913', 'cui_str': 'Bilirubin, total measurement'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}]",46.0,0.453148,"There was no significant difference in PSV, EDV, and RI between the two groups at all time points after birth ( P > 0.05).","[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Department of Pediatrics, Suining Central Hospital, Suining, Sichuan 629000, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Peng', 'Affiliation': 'Department of Pediatrics, Suining Central Hospital, Suining, Sichuan 629000, China.'}]",Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics,[] 3641,33840229,"A Phase II, Multicenter, Randomized, Placebo-Controlled Study of Benralizumab, a Humanized Anti-IL-5R Alpha Monoclonal Antibody, in Patients With Eosinophilic Chronic Rhinosinusitis.","BACKGROUND Strong eosinophil infiltration in chronic rhinosinusitis with nasal polyp (CRSwNP) is highly associated with recalcitrance and higher nasal polyp recurrence rate after surgery. The prevalence of eosinophilic CRSwNP (ECRS) is increasing in Asian countries including Japan. Benralizumab is a humanized anti-IL-5R alpha monoclonal antibody that depletes eosinophils by antibody-dependent cell-mediated cytotoxicity. OBJECTIVE To assess the efficacy and safety of benralizumab in patients with ECRS. METHODS This phase II, randomized, double-blind, placebo-controlled study was conducted in Japan. Patients were randomized 1:2:2 to placebo, a single administration of benralizumab 30 mg, or benralizumab 30 mg every 4 weeks (q4w) for a total of three doses. The primary endpoint was the change in nasal polyp score from baseline at Week 12. RESULTS Overall, 56 patients were enrolled (placebo, n = 11; benralizumab single dose, n = 22; benralizumab q4w, n = 23). Although the mean total nasal polyp score began to decrease after the initiation of benralizumab treatment, there were no statistically significant differences in change in nasal polyp score from baseline at Week 12 between benralizumab and placebo (placebo, -0.5 ± 0.8; benralizumab single, -0.3 ± 0.8; benralizumab q4w, -0.5 ± 1.5). Post-hoc analysis showed that the administration of benralizumab decreased nasal polyp scores ≥2 points in 42.2% of ECRS patients and that patients with high blood eosinophil levels had a greater tendency to respond to benralizumab treatment. The safety profile was similar to that in previous studies and no unexpected adverse events were noted. CONCLUSION Although benralizumab did not meet the primary efficacy endpoint, reductions of nasal polyp scores were seen in the benralizumab group compared with the placebo group over the whole study period, especially in patients with high levels of blood eosinophils.",2021,Post-hoc analysis showed that the administration of benralizumab decreased nasal polyp scores ≥2 points in 42.2% of ECRS patients and that patients with high blood eosinophil levels had a greater tendency to respond to benralizumab treatment.,"['patients with ECRS', 'Japan', '56 patients were enrolled (placebo, n\u2009=\u200911; benralizumab single dose, n\u2009=\u200922; benralizumab q4w, n\u2009=\u200923', 'Patients With Eosinophilic Chronic Rhinosinusitis', 'chronic rhinosinusitis with nasal polyp (CRSwNP', 'Asian countries including Japan']","['placebo (placebo', 'Benralizumab', 'benralizumab', 'placebo', 'benralizumab 30 mg, or benralizumab', 'Placebo', 'ECRS']","['mean total nasal polyp score', 'blood eosinophils', 'change in nasal polyp score', 'efficacy and safety', 'nasal polyp scores', 'nasal polyp score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2982078', 'cui_str': 'benralizumab'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0454705', 'cui_str': 'Asian country'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2982078', 'cui_str': 'benralizumab'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",56.0,0.273362,Post-hoc analysis showed that the administration of benralizumab decreased nasal polyp scores ≥2 points in 42.2% of ECRS patients and that patients with high blood eosinophil levels had a greater tendency to respond to benralizumab treatment.,"[{'ForeName': 'Tetsuji', 'Initials': 'T', 'LastName': 'Takabayashi', 'Affiliation': 'Department of Otorhinolaryngology-Head & Neck Surgery, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Daiya', 'Initials': 'D', 'LastName': 'Asaka', 'Affiliation': 'Department of Otorhinolaryngology, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Okamoto', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Chiba University, Chiba, Japan.'}, {'ForeName': 'Tetsuo', 'Initials': 'T', 'LastName': 'Himi', 'Affiliation': 'Department of Otolaryngology, Sapporo Medical University, Hokkaido, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Haruna', 'Affiliation': 'Department of Otorhinolaryngology, Head & Neck Surgery, Dokkyo Medical University, Tochigi, Japan.'}, {'ForeName': 'Naohiro', 'Initials': 'N', 'LastName': 'Yoshida', 'Affiliation': 'Department of Otolaryngology, Jichi Medical University Saitama Medical Center, Saitama, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Kondo', 'Affiliation': 'Department of Otolaryngology, University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Mamoru', 'Initials': 'M', 'LastName': 'Yoshikawa', 'Affiliation': 'Department of Otorhinolaryngology, Toho University Ohashi Medical Center, Tokyo, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Sakuma', 'Affiliation': 'Department of Otorhinolaryngology, Yokohama City University Medical Center, Kanagawa, Japan.'}, {'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Shibata', 'Affiliation': 'Department of Otorhinolaryngology, Yokohama City University Medical Center, Kanagawa, Japan.'}, {'ForeName': 'Motohiko', 'Initials': 'M', 'LastName': 'Suzuki', 'Affiliation': 'Departments of Otorhinolaryngology, Nagoya City University, Aichi, Japan.'}, {'ForeName': 'Masayoshi', 'Initials': 'M', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Mie University Graduate School of Medicine, Mie, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Kawata', 'Affiliation': 'Department of Otolaryngology, Head & Neck Surgery, Osaka Medical College, Osaka, Japan.'}, {'ForeName': 'Kenzo', 'Initials': 'K', 'LastName': 'Tsuzuki', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Hyogo College of Medicine, Hyogo, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Okano', 'Affiliation': 'Department of Otorhinolaryngology, International University of Health and Welfare Mita Hospital, Tokyo, Japan.'}, {'ForeName': 'Takaya', 'Initials': 'T', 'LastName': 'Higaki', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Sachio', 'Initials': 'S', 'LastName': 'Takeno', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Graduate School of Biomedical Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Kodama', 'Affiliation': 'Kodama Jibiinkoka Clinic, Oita, Japan.'}, {'ForeName': 'Syuji', 'Initials': 'S', 'LastName': 'Yonekura', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Chiba University, Chiba, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Saito', 'Affiliation': 'R&D Division, Kyowa kirin Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Akiyo', 'Initials': 'A', 'LastName': 'Nozaki', 'Affiliation': 'R&D Division, Kyowa kirin Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Nobuyoshi', 'Initials': 'N', 'LastName': 'Otori', 'Affiliation': 'Department of Otorhinolaryngology, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shigeharu', 'Initials': 'S', 'LastName': 'Fujieda', 'Affiliation': 'Department of Otorhinolaryngology-Head & Neck Surgery, University of Fukui, Fukui, Japan.'}]",American journal of rhinology & allergy,['10.1177/19458924211009429'] 3642,33839489,Effect of nasal corticosteroid in the treatment of anosmia due to COVID-19: A randomised double-blind placebo-controlled study.,"OBJECTIVES Anosmia is a common debilitating symptom of the novel coronavirus disease 2019 (COVID-19). Currently, there is no satisfactory treatment of anosmia. Therefore, this study was conducted to evaluate the therapeutic effect of nasal betamethasone drops in the recovery of olfaction in COVID-19-associated anosmia. METHODS The study was designed as a randomised, double-blind, placebo-controlled clinical trial. In total, 276 PCR-confirmed COVID-19 patients who were presented to the outpatient clinic with anosmia were enrolled in the study. In the betamethasone group, 138 participants received nasal drops of betamethasone 3 times daily until recovery for a maximum of one month. Similar dose of 9% NaCl drops was administered to 138 participants in the placebo group. RESULTS The median age of participants was 29 years (IQR 23-37). Among them, 198 (71.7%) were females. Ageusia was co-presented with anosmia in 234 (84.8%) of participants. In this study, 83% of participants had recovered from anosmia within 30 days, with a median recovery time of 13 days (IQR 8-18). Compared to placebo, nasal application of betamethasone drops has no significant effect on the recovery time of anosmia (hazard ratio 0.88; 95% CI 0.68-1.14; P = 0.31). CONCLUSION The use of nasal betamethasone to facilitate the recovery time of acute anosmia is not advised. In addition, age, smoking status, the duration of anosmia at presentation, and the co-presentation of ageusia with anosmia are important determinant covariates for the recovery time of anosmia. Further clinical trials, which take these covariates into account, will need to be undertaken. The trail has been registered at ClinicalTrails.gov, NCT04569825.",2021,"Compared to placebo, nasal application of betamethasone drops has no significant effect on the recovery time of anosmia (hazard ratio 0.88; 95% CI 0.68-1.14; P = 0.31). ","['Among them, 198 (71.7%) were females', 'In total, 276 PCR-confirmed COVID-19 patients who were presented to the outpatient clinic with anosmia were enrolled in the study', 'anosmia due to COVID-19', '138 participants in the placebo group', '138 participants received']","['nasal drops of betamethasone', 'nasal corticosteroid', 'placebo', 'nasal betamethasone', 'betamethasone', 'NaCl']","['recovery time of anosmia', 'median recovery time']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0003126', 'cui_str': 'Loss of sense of smell'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0991524', 'cui_str': 'Nasal drops'}, {'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003126', 'cui_str': 'Loss of sense of smell'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.609018,"Compared to placebo, nasal application of betamethasone drops has no significant effect on the recovery time of anosmia (hazard ratio 0.88; 95% CI 0.68-1.14; P = 0.31). ","[{'ForeName': 'Rasheed Ali', 'Initials': 'RA', 'LastName': 'Rashid', 'Affiliation': 'Department of Surgery, College of Medicine, Tikrit University, Tikrit, 34001, Iraq.'}, {'ForeName': 'Atheer', 'Initials': 'A', 'LastName': 'Zgair', 'Affiliation': 'Department of Pharmacology and Toxicology, College of Pharmacy, University of Anbar, Ramadi, 31001, Iraq. Electronic address: ph.atheer.zgair@uoanbar.edu.iq.'}, {'ForeName': 'Raid M', 'Initials': 'RM', 'LastName': 'Al-Ani', 'Affiliation': 'Department of Surgery, College of Medicine, University of Anbar, Ramadi, 31001, Iraq.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2021.103033'] 3643,33838658,Person-centered antenatal care and associated factors in Rwanda: a secondary analysis of program data.,"BACKGROUND Research suggests that women's experience of antenatal care is an important component of high-quality antenatal care. Person-centered antenatal care (PCANC) reflects care that is both respectful of, and responsive to, the preferences, needs, and values of pregnant women. Little is known in Rwanda about either the extent to which PCANC is practiced or the factors that might determine its use. This is the first study to quantitatively examine the extent of and the factors associated with PCANC in Rwanda. METHODS We used quantitative data from a randomized control trial in Rwanda. A total of 2150 surveys were collected and analyzed from 36 health centers across five districts. We excluded women who were less than 16 years old, were referred to higher levels of antenatal care or had incomplete survey responses. Both bivariate and multivariate logistic regression analyses were used to test the hypothesis that certain participant characteristics would predict high PCANC. RESULTS PCANC level was found to be sub-optimal with one third of women leaving antenatal care (ANC) with questions or confused and one fourth feeling disrespected. In bivariate analysis, social support, greater parity, being in the traditional care (control group), and being from Burera district significantly predict high PCANC. Additionally, in the multivariate analysis, being in the traditional care group and the district in which women received care were significantly associated with PCANC. CONCLUSIONS This quantitative analysis indicates sub-optimal levels of PCANC amongst our study population in Rwanda. We find lower levels of PCANC to be regional and defined by the patient characteristics parity and social support. Given the benefits of PCANC, improvements in PCANC through provider training in Rwanda might promote an institutional culture shift towards a more person-centered model of care.",2021,"In bivariate analysis, social support, greater parity, being in the traditional care (control group), and being from Burera district significantly predict high PCANC.","['excluded women who were less than 16\u2009years old, were referred to higher levels of antenatal care or had incomplete survey responses', 'pregnant women', 'A total of 2150 surveys were collected and analyzed from 36 health centers across five districts']","['PCANC', 'Person-centered antenatal care (PCANC']",[],"[{'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0475309', 'cui_str': 'Health center'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}]",[],2150.0,0.0276065,"In bivariate analysis, social support, greater parity, being in the traditional care (control group), and being from Burera district significantly predict high PCANC.","[{'ForeName': 'Phoebe', 'Initials': 'P', 'LastName': 'Miller', 'Affiliation': 'University of California San Francisco, San Francisco, USA. phoebe.miller@ucsf.edu.'}, {'ForeName': 'Patience A', 'Initials': 'PA', 'LastName': 'Afulani', 'Affiliation': 'University of California San Francisco, San Francisco, USA.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Musange', 'Affiliation': 'University of Rwanda School of Public Health, Kigali, Rwanda.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Sayingoza', 'Affiliation': 'Rwanda Biomedical Center, Kigali, Rwanda.'}, {'ForeName': 'Dilys', 'Initials': 'D', 'LastName': 'Walker', 'Affiliation': 'University of California San Francisco, San Francisco, USA.'}]",BMC pregnancy and childbirth,['10.1186/s12884-021-03747-z'] 3644,33838657,"Methylprednisolone or dexamethasone, which one is superior corticosteroid in the treatment of hospitalized COVID-19 patients: a triple-blinded randomized controlled trial.","BACKGROUND Although almost a year has passed since the Coronavirus disease 2019 (COVID-19) outbreak and promising reports of vaccines have been presented, we still have a long way until these measures are available for all. Furthermore, the most appropriate corticosteroid and dose in the treatment of COVID-19 have remained uncertain. We conducted a study to assess the effectiveness of methylprednisolone treatment versus dexamethasone for hospitalized COVID-19 patients. METHODS In this prospective triple-blinded randomized controlled trial, we enrolled 86 hospitalized COVID-19 patients from August to November 2020, in Shiraz, Iran. The patients were randomly allocated into two groups to receive either methylprednisolone (2 mg/kg/day; intervention group) or dexamethasone (6 mg/kg/day; control group). Data were assessed based on a 9-point WHO ordinal scale extending from uninfected (point 0) to death (point 8). RESULTS There were no significant differences between the groups on admission. However, the intervention group demonstrated significantly better clinical status compared to the control group at day 5 (4.02 vs. 5.21, p = 0.002) and day 10 (2.90 vs. 4.71, p = 0.001) of admission. There was also a significant difference in the overall mean score between the intervention group and the control group, (3.909 vs. 4.873 respectively, p = 0.004). The mean length of hospital stay was 7.43 ± 3.64 and 10.52 ± 5.47 days in the intervention and control groups, respectively (p = 0.015). The need for a ventilator was significantly lower in the intervention group than in the control group (18.2% vs 38.1% p = 0.040). CONCLUSION In hospitalized hypoxic COVID-19 patients, methylprednisolone demonstrated better results compared to dexamethasone. TRIAL REGISTRATION The trial was registered with IRCT.IR (08/04/2020-No. IRCT20200204046369N1 ).",2021,"The need for a ventilator was significantly lower in the intervention group than in the control group (18.2% vs 38.1% p = 0.040). ","['86 hospitalized COVID-19 patients from August to November 2020, in Shiraz, Iran', 'hospitalized COVID-19 patients']","['dexamethasone', 'IRCT.IR', 'methylprednisolone', 'Methylprednisolone or dexamethasone']","['mean length of hospital stay', 'overall mean score', 'clinical status']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}]",86.0,0.236146,"The need for a ventilator was significantly lower in the intervention group than in the control group (18.2% vs 38.1% p = 0.040). ","[{'ForeName': 'Keivan', 'Initials': 'K', 'LastName': 'Ranjbar', 'Affiliation': 'Thoracic and Vascular Surgery Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Moghadami', 'Affiliation': 'Health Policy research center, Institute of Health, Shiraz University of Medical Sciences, Shiraz, Iran. moghadami@sums.ac.ir.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Mirahmadizadeh', 'Affiliation': 'Health Policy research center, Institute of Health, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad Javad', 'Initials': 'MJ', 'LastName': 'Fallahi', 'Affiliation': 'Thoracic and Vascular Surgery Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Khaloo', 'Affiliation': 'Ali Asghar hospital, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Shahriarirad', 'Affiliation': 'Thoracic and Vascular Surgery Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Amirhossein', 'Initials': 'A', 'LastName': 'Erfani', 'Affiliation': 'Thoracic and Vascular Surgery Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Zohre', 'Initials': 'Z', 'LastName': 'Khodamoradi', 'Affiliation': 'Department of Internal Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad Hasan', 'Initials': 'MH', 'LastName': 'Gholampoor Saadi', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",BMC infectious diseases,['10.1186/s12879-021-06045-3'] 3645,33852252,Four-Week Daily Calcipotriene/Betamethasone Dipropionate Foam Is Highly Efficacious in Patients With Psoriasis (PSO-LONG Lead-in Phase).,"BACKGROUND Psoriasis is a chronic disease requiring long-term treatment strategies. Optimal strategies should include initial rapid relief of symptoms followed by long-term management to maintain remission. This 4-week open-label phase of a long-term proactive management phase 3 trial aimed to select responders to once daily, fixed-dose combination calcipotriene 0.005% and betamethasone dipropionate 0.064% (Cal/BD) foam in adults with psoriasis and assess patient-reported outcomes. METHOD This phase 3 trial in adults with psoriasis included a 4-week open-label lead-in phase to determine treatment success prior to entering the randomized maintenance phase. Success was defined as Physician Global Assessment (PGA) score ‘clear’/‘almost clear’ (PGA <2) with ≥2-grade improvement from baseline. Those achieving treatment success at week 4 entered the maintenance phase; non-responders were withdrawn from the trial. RESULTS 650 patients enrolled in the open-label phase, and 623 were treated with Cal/BD foam for 4 weeks; 521 (80%) patients achieved treatment success and were included in the maintenance phase. In those patients achieving success (responders), 21.1% and 78.9% achieved a PGA score of ‘clear’ and ‘almost clear’, respectively. Mean change from baseline in modified Psoriasis Area and Severity Index (± standard deviation [SD]) and body surface area (± SD) in responders at week 4 was −82.1% (16.4%) and −56.6% (38.3%), respectively. Mean Dermatology Life Quality Index score reduced by 6.0 from baseline to week 4 (n=521). 17.7% of patients experienced AEs; with only one severe AE reported. CONCLUSION Cal/BD foam was highly efficacious and well tolerated during the 4-week lead-in phase of PSO-LONG. J Drugs Dermatol. 2021;20(4):436-441, doi:10.36849/JDD.5728.",2021,Mean Dermatology Life Quality Index score reduced by 6.0 from baseline to week 4 (n=521).,"['Patients With Psoriasis (PSO-LONG Lead-in Phase', 'adults with psoriasis', 'adults with psoriasis and assess patient-reported outcomes', '650 patients enrolled in the open-label phase, and 623 were treated with']","['Calcipotriene/Betamethasone Dipropionate Foam', 'betamethasone dipropionate', 'Cal/BD']","['Mean Dermatology Life Quality Index score', 'PGA score of ‘clear’ and ‘almost clear&rsquo', 'modified Psoriasis Area and Severity Index (± standard deviation [SD]) and body surface area (± SD', 'Physician Global Assessment (PGA) score ‘clear’/‘almost clear’ (PGA <2']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C3844101', 'cui_str': '650'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0065767', 'cui_str': 'calcipotriene'}, {'cui': 'C0053523', 'cui_str': 'Betamethasone dipropionate'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C4517389', 'cui_str': '0.005'}, {'cui': 'C4517414', 'cui_str': '0.064'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4706308', 'cui_str': 'DLQI (Dermatology Life Quality Index) score'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",650.0,0.0589749,Mean Dermatology Life Quality Index score reduced by 6.0 from baseline to week 4 (n=521).,"[{'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Warren', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gold', 'Affiliation': ''}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Gooderham', 'Affiliation': ''}, {'ForeName': 'Leon H', 'Initials': 'LH', 'LastName': 'Kircik', 'Affiliation': ''}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Lacour', 'Affiliation': ''}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Laws', 'Affiliation': ''}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Liljedahl', 'Affiliation': ''}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Lynde', 'Affiliation': ''}, {'ForeName': 'Marie Holst', 'Initials': 'MH', 'LastName': 'Mørch', 'Affiliation': ''}, {'ForeName': 'Wiebke', 'Initials': 'W', 'LastName': 'Sondermann', 'Affiliation': ''}, {'ForeName': 'Diamant', 'Initials': 'D', 'LastName': 'Thaçi', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.2021.5728'] 3646,32561500,Identification of Radioresponsive Genes in Esophageal Cancer from Longitudinal and Single Cell Exome Sequencing.,"PURPOSE The majority (70%) of the esophageal squamous cell carcinoma (ESCC) cases in the world occur in China, where radiation therapy is the most common treatment. Yet the majority of ESCC patients still relapse. METHODS AND MATERIALS To better understand the genetic basis of radiation therapy resistance for ESCC, we performed longitudinal, whole-exome sequencing throughout radiation therapy on 42 patient tumor samples, including single-cell whole-exome sequencing for 147 cells for 2 patients. RESULTS Significant allelic changes were observed during clinical irradiation, with 42 recurrent radioresponsive genes (sensitive and resistant) identified in multiple patients, including NOTCH1, MAML3, CDKN2A, NFE2L2, GAS2L2, OBSCN and TP53, with the last 3 genes implicated as radioresponsive in both bulk and single-cell whole-exome sequencing. Most (37/42) radioresponsive genes showed regional variegation in both radioresistant and radiosensitive mutations, with a paucity of resistant-only mutations (2.5%). A subset of sensitive mutations in 10 genes and resistant mutations in 18 genes defined a significantly improved prognosis and the shortest time for locoregional recurrence, respectively, indicating possible clinical utility. We also confirmed these significant mutational signatures in orthogonal Cancer Genome Atlas ESCC cohorts. CONCLUSIONS Overall, our results quantify the allelic shifts underlying radioresponse in bulk and single-cell ESCC exomes for the first time, provide a temporal resolution to such mutational dynamics, and offer new therapeutic target genes and loci for esophageal and potentially other cancers.",2020,"A subset of sensitive mutations in 10 genes and resistant mutations in 18 genes defined a significantly improved prognosis and the shortest time for locoregional recurrence, respectively, indicating possible clinical utility.","['42 patient tumor samples, including single-cell whole-exome sequencing for 147 cells for 2 patients', 'esophageal squamous cell carcinoma (ESCC) cases in the world occur in China']",[],['shortest time for locoregional recurrence'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C3640077', 'cui_str': 'Complete Exome Sequencing'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0008115', 'cui_str': 'China'}]",[],"[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.192734,"A subset of sensitive mutations in 10 genes and resistant mutations in 18 genes defined a significantly improved prognosis and the shortest time for locoregional recurrence, respectively, indicating possible clinical utility.","[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Hangzhou Cancer Institute, Hangzhou Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'MacKay', 'Affiliation': 'Department of Physiology and Biophysics, Weill Cornell Medical College, New York, New York; The HRH Prince Alwaleed Bin Talal Bin Abdulaziz Alsaud Institute for Computational Biomedicine, Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Foox', 'Affiliation': 'Department of Physiology and Biophysics, Weill Cornell Medical College, New York, New York; The HRH Prince Alwaleed Bin Talal Bin Abdulaziz Alsaud Institute for Computational Biomedicine, Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Hou', 'Affiliation': 'Hangzhou Cancer Institute, Hangzhou Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'Hangzhou Cancer Institute, Hangzhou Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Rongjing', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': 'Department of Pathology, Hangzhou Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Hangzhou Cancer Institute, Hangzhou Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Jing', 'Affiliation': 'Hangzhou Cancer Institute, Hangzhou Cancer Hospital, Hangzhou, China; Department of Radiation Oncology, Hangzhou Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Mason', 'Affiliation': 'Department of Physiology and Biophysics, Weill Cornell Medical College, New York, New York; The HRH Prince Alwaleed Bin Talal Bin Abdulaziz Alsaud Institute for Computational Biomedicine, Weill Cornell Medicine, New York, New York; The Feil Family Brain and Mind Research Institute (BMRI), New York, New York.'}, {'ForeName': 'Shixiu', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen, China. Electronic address: wushixiu@zju.edu.cn.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.06.015'] 3647,32350790,"Development of the Observation Schedule for Children with Autism-Anxiety, Behaviour and Parenting (OSCA-ABP): A New Measure of Child and Parenting Behavior for Use with Young Autistic Children.","Co-occurring emotional and behavioral problems (EBPs) frequently exist in young autistic children. There is evidence based on parental report that parenting interventions reduce child EBPs. More objective measures of child EBPs should supplement parent reported outcomes in trials. We describe the development of a new measure of child and parenting behavior, the Observation Schedule for Children with Autism-Anxiety, Behaviour and Parenting (OSCA-ABP). Participants were 83 parents/carers and their 4-8-year-old autistic children. The measure demonstrated good variance and potential sensitivity to change. Child and parenting behavior were reliably coded among verbal and minimally verbal children. Associations between reports from other informants and observed behavior showed the measure had sufficient convergent validity. The measure has promise to contribute to research and clinical practice in autism mental health beyond objective measurement in trials.",2021,"We describe the development of a new measure of child and parenting behavior, the Observation Schedule for Children with Autism-Anxiety, Behaviour and Parenting (OSCA-ABP).","['Young Autistic Children', 'Participants were 83 parents/carers and their 4-8-year-old autistic children', 'young autistic children', 'Children with Autism-Anxiety, Behaviour and Parenting (OSCA-ABP']",['Co-occurring emotional and behavioral problems (EBPs'],['Child and parenting behavior'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}]",83.0,0.0550674,"We describe the development of a new measure of child and parenting behavior, the Observation Schedule for Children with Autism-Anxiety, Behaviour and Parenting (OSCA-ABP).","[{'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Palmer', 'Affiliation': ""Department of Child and Adolescent Psychiatry, King's College London, Institute of Psychiatry, Psychology & Neuroscience, London, UK. melanie.palmer@kcl.ac.uk.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Paris Perez', 'Affiliation': ""Department of Child and Adolescent Psychiatry, King's College London, Institute of Psychiatry, Psychology & Neuroscience, London, UK.""}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Tarver', 'Affiliation': ""Department of Child and Adolescent Psychiatry, King's College London, Institute of Psychiatry, Psychology & Neuroscience, London, UK.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Cawthorne', 'Affiliation': ""Department of Child and Adolescent Psychiatry, King's College London, Institute of Psychiatry, Psychology & Neuroscience, London, UK.""}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'Frayne', 'Affiliation': ""Department of Child and Adolescent Psychiatry, King's College London, Institute of Psychiatry, Psychology & Neuroscience, London, UK.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Webb', 'Affiliation': ""Department of Psychology, King's College London, Institute of Psychiatry, Psychology & Neuroscience, London, UK.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Baker', 'Affiliation': ""Department of Child and Adolescent Psychiatry, King's College London, Institute of Psychiatry, Psychology & Neuroscience, London, UK.""}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Yorke', 'Affiliation': ""Department of Child and Adolescent Psychiatry, King's College London, Institute of Psychiatry, Psychology & Neuroscience, London, UK.""}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Hay', 'Affiliation': 'School of Psychology, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Slonims', 'Affiliation': ""Newcomen Neurodevelopmental Centre, Evelina Children's Hospital, Guy's and St Thomas NHS Foundation Trust, London, UK.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Pickles', 'Affiliation': ""Department of Biostatistics and Health Informatics, King's College London, Institute of Psychiatry, Psychology & Neuroscience, London, UK.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Simonoff', 'Affiliation': ""Department of Child and Adolescent Psychiatry, King's College London, Institute of Psychiatry, Psychology & Neuroscience, London, UK.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Scott', 'Affiliation': ""Department of Child and Adolescent Psychiatry, King's College London, Institute of Psychiatry, Psychology & Neuroscience, London, UK.""}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Charman', 'Affiliation': ""Department of Psychology, King's College London, Institute of Psychiatry, Psychology & Neuroscience, London, UK.""}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04506-3'] 3648,32331806,"Antibodies to measles, mumps, and rubella virus in Thai children after two-dose vaccination at 9 months and 2.5 years: A longitudinal study.","INTRODUCTION Thailand changed the schedule of childhood measles-mumps-rubella (MMR) vaccination in 2014, moving the second dose from the age of 6 years to 2.5 years. There are currently no data on antibody responses to the MMR vaccine since this recommendation. MATERIAL AND METHODS We investigated antibody responses in a cohort of children who received two doses of MMR vaccine at the ages of 9 months and 2.5 years that was originally established to evaluate antibody levels to Bordetella pertussis antigens (ClinicalTrials.gov no. NCT02408926). Infants were born to mothers who previously received tetanus-diphtheria-acellular pertussis vaccine at 27-36 weeks of gestation. Anti-measles, -mumps, and -rubella virus IgG levels were measured at birth (cord blood) and the ages of 2 and 7 months (before the first MMR vaccination); 18 and 24 months (9 and 15 months, respectively, after the first dose); and 36 months (6 months after the second dose) using commercially available enzyme-linked immunosorbent assay kits. RESULTS At 7 months of age, 96.2%, 99.6%, and 98.8% of infants had no protection against measles, mumps, and rubella, respectively. Levels of antibody against all three antigens increased significantly after the first but not the second dose. At 6 months after two-dose vaccination, 97.4%, 84.8%, and 78.7% of children remained seroprotected against measles, mumps, and rubella, respectively. CONCLUSIONS Maternally derived antibodies to measles, mumps, and rubella virus disappeared by the age of 7 months in Thai children. Two-dose MMR vaccination at 9 months and 2.5 years of age induced robust immune responses against these viruses.",2020,Levels of antibody against all three antigens increased significantly after the first but not the second dose.,['a cohort of children who received two doses of'],"['tetanus-diphtheria-acellular pertussis vaccine', 'MMR vaccine']","['Anti-measles, -mumps, and -rubella virus IgG levels', 'Levels of antibody']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]","[{'cui': 'C0039614', 'cui_str': 'Tetanus'}, {'cui': 'C0012546', 'cui_str': 'Diphtheria'}, {'cui': 'C0982332', 'cui_str': 'acellular pertussis vaccine, inactivated'}, {'cui': 'C0035923', 'cui_str': 'Rubella virus vaccine'}]","[{'cui': 'C0369957', 'cui_str': 'Rubella virus IgG'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]",,0.206626,Levels of antibody against all three antigens increased significantly after the first but not the second dose.,"[{'ForeName': 'Nasamon', 'Initials': 'N', 'LastName': 'Wanlapakorn', 'Affiliation': 'Center of Excellence in Clinical Virology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Division of Academic Affairs, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Jiratchaya', 'Initials': 'J', 'LastName': 'Puenpa', 'Affiliation': 'Center of Excellence in Clinical Virology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Thanunrat', 'Initials': 'T', 'LastName': 'Thongmee', 'Affiliation': 'Center of Excellence in Clinical Virology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Donchida', 'Initials': 'D', 'LastName': 'Srimuan', 'Affiliation': 'Center of Excellence in Clinical Virology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Thaksaporn', 'Initials': 'T', 'LastName': 'Thatsanathorn', 'Affiliation': 'Center of Excellence in Clinical Virology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Sompong', 'Initials': 'S', 'LastName': 'Vongpunsawad', 'Affiliation': 'Center of Excellence in Clinical Virology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Poovorawan', 'Affiliation': 'Center of Excellence in Clinical Virology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Academy of Science, Royal Society of Thailand, Bangkok, Thailand. Electronic address: yong.p@chula.ac.th.'}]",Vaccine,['10.1016/j.vaccine.2020.04.013'] 3649,30712326,Metacognitive improvement and symptom change in a 3-month treatment for borderline personality disorder.,"OBJECTIVES Recognizing and reflecting on one's own and other people's mental states represent a major difficulty for patients with borderline personality disorder (BPD). Only recently have studies begun exploring whether these capacities increase with successful therapies and if such an improvement is linked with outcome. The present study investigated whether metacognition would improve and if its improvement was related with symptom change in BPD patients. DESIGN The transcripts from the first and the penultimate session of a ten-session version of good psychiatric management were analysed with the MAS-R scale in a N = 37 BPD sample. Patients, selected from a previously published RCT (Kramer et al., 2014), were assigned either to the good psychiatric management treatment or to the same treatment with the addition of the Motive-Oriented Therapeutic Relationship (Caspar, 2007), a form of therapeutic relationship based on an individualized case formulation. Symptoms were assessed with the OQ-45. RESULTS Findings partially support the hypotheses. First, improvement in capacities to understand others' mind, to take a critical distance from one's own rigid and maladaptive beliefs, and to use behavioural and attentional strategies to face adversities is found in both treatment groups. Controlling for marital status, only the ability to differentiate between reality and representations remains significant. Second, no link between metacognitive change and symptom change during treatment is found. However, a link is observed between the increase in metacognition and symptom reduction at 6-month follow-up. CONCLUSIONS Results invite to further investigate the role of metacognition in therapy change through different modalities and in longer-term treatments. PRACTITIONER POINTS The development of metacognitive processes and their links with symptom change were examined during a short-term treatment in 37 borderline patients Improvement was found in capacities to understand others' mind, to take a critical distance from own rigid and maladaptive beliefs, and to use behavioural and attentional strategies even in a short-term treatment Controlling for marital status, only the ability to take a critical distance from representations remained significant A link was observed between increase in metacognition and symptom reduction at 6-month follow-up Understanding and tailoring interventions to specific metacognitive difficulties could be associated with symptom change during treatment for BPD patients.",2020,"However, a link is observed between the increase in metacognition and symptom reduction at 6-month follow-up. ","['Patients, selected from a previously published RCT (Kramer et\xa0al., 2014', 'patients with borderline personality disorder (BPD', '37 BPD sample', '37 borderline patients', 'borderline personality disorder', 'BPD patients']","['good psychiatric management treatment or to the same treatment with the addition of the Motive-Oriented Therapeutic Relationship (Caspar, 2007), a form of therapeutic relationship based on an individualized case formulation']","['MAS-R scale', 'Metacognitive improvement and symptom change', 'metacognition and symptom reduction', 'metacognitive change and symptom change']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034037', 'cui_str': 'Publishing'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0030677', 'cui_str': 'Patient Care Management'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0589513', 'cui_str': 'Metacognition'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.027637,"However, a link is observed between the increase in metacognition and symptom reduction at 6-month follow-up. ","[{'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Maillard', 'Affiliation': 'Institute of Psychotherapy-University Hospital Center, University of Lausanne, Switzerland.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Dimaggio', 'Affiliation': 'Centro di Terapia Metacognitiva Interpersonale, Rome, Italy.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Berthoud', 'Affiliation': 'Institute of Psychotherapy-University Hospital Center, University of Lausanne, Switzerland.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'de Roten', 'Affiliation': 'Institute of Psychotherapy-University Hospital Center, University of Lausanne, Switzerland.'}, {'ForeName': 'Jean-Nicolas', 'Initials': 'JN', 'LastName': 'Despland', 'Affiliation': 'Institute of Psychotherapy-University Hospital Center, University of Lausanne, Switzerland.'}, {'ForeName': 'Ueli', 'Initials': 'U', 'LastName': 'Kramer', 'Affiliation': 'Institute of Psychotherapy-University Hospital Center, University of Lausanne, Switzerland.'}]",Psychology and psychotherapy,['10.1111/papt.12219'] 3650,33852251,"A Phase 3, Randomized Trial Demonstrating the Improved Efficacy and Patient Acceptability of Fixed Dose Calcipotriene and Betamethasone Dipropionate Cream.","BACKGROUND The fixed dose combination of calcipotriene and betamethasone dipropionate (CAL/BDP) is a well-established, efficacious, and safe topical treatment of psoriasis. METHOD A Phase 3, multicenter, randomized, investigator-blind, active, and vehicle-controlled trial enrolling 796 patients with moderate to severe psoriasis according to the Physician Global Assessment (PGA) scale. Products were applied once daily for 8 weeks. RESULTS The proportion of patients achieving PGA treatment success after 8 weeks was statistically significantly greater for CAL/BDP cream (37.4%) compared to CAL/BDP TS (22.8%, P<0.0001), and vehicle (3.7%, P<0.0001). A similar statistically significant difference in favor of CAL/BDP cream at week 8 was demonstrated for the percentage change in mPASI from baseline and the proportion of patients obtaining mPASI75. Patient reported treatment convenience for CAL/BDP cream was rated superior to CAL/BDP TS. Safety assessments during the trial demonstrated that CAL/BDP cream was well-tolerated with no adverse reactions with a frequency greater than 1%. CONCLUSION CAL/BDP cream is a novel topical treatment of psoriasis, which in a single product, offers a unique combination of high efficacy combined with favorable safety and excellent treatment convenience. For these reasons, CAL/BDP cream offers a distinctive advantage for the topical treatment of plaque psoriasis. ClinicalTrials.gov: NCT03308799J Drugs Dermatol. 20(4):420-425. doi:10.36849/JDD.5653.",2021,"The proportion of patients achieving PGA treatment success after 8 weeks was statistically significantly greater for CAL/BDP cream (37.4%) compared to CAL/BDP TS (22.8%, P<0.0001), and vehicle (3.7%, P<0.0001).",['796 patients with moderate to severe psoriasis according to the Physician Global Assessment (PGA) scale'],"['Calcipotriene and Betamethasone Dipropionate Cream', 'CAL/BDP cream', 'calcipotriene and betamethasone dipropionate (CAL/BDP']","['CAL/BDP cream', 'proportion of patients achieving PGA treatment success']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0065767', 'cui_str': 'calcipotriene'}, {'cui': 'C0053523', 'cui_str': 'Betamethasone dipropionate'}, {'cui': 'C0700385', 'cui_str': 'Cream'}]","[{'cui': 'C0065767', 'cui_str': 'calcipotriene'}, {'cui': 'C0053523', 'cui_str': 'Betamethasone dipropionate'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",796.0,0.0812497,"The proportion of patients achieving PGA treatment success after 8 weeks was statistically significantly greater for CAL/BDP cream (37.4%) compared to CAL/BDP TS (22.8%, P<0.0001), and vehicle (3.7%, P<0.0001).","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Stein Gold', 'Affiliation': ''}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Green', 'Affiliation': ''}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Dhawan', 'Affiliation': ''}, {'ForeName': 'Birgitte', 'Initials': 'B', 'LastName': 'Vestbjerg', 'Affiliation': ''}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Praestegaard', 'Affiliation': ''}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Selmer', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.2021.5653'] 3651,33852250,Carboxytherapy Mask as Post Nanofractional Radiofrequency Treatment for Improvement of Facial Skin Quality and Photoaging.,"BACKGROUND Skin rejuvenation can be achieved with minimally invasive treatments using energy-based devices that feature reduced side effects and downtime. Post-treatment care is key to minimize any potential side effects and skin reactions such as erythema, dryness, or dyschromia. OBJECTIVE The objective of this study was to evaluate the efficacy and patient satisfaction of a novel carboxytherapy gel mask compared with petroleum-based lanolin-containing ointment to accelerate wound healing facial post-nanofractional radiofrequency treatment. METHODS AND MATERIALS Ten subjects were enrolled in this pilot, prospective, randomized, single-blind study and randomized into two arms. One arm received one nanofractional radiofrequency treatment with ointment right after and four consecutive days of ointment applications twice a day, while the second arm followed this regimen with a carboxytherapy gel mask application right after and four consecutive days after treatment. Investigator, safety, and patient assessments were conducted at 24 hours and one-week post treatment. Safety was monitored throughout. The primary endpoint was defined as the degree of investigator global assessment (IGA) in photodamage, pigmentation, and wrinkles using standardized photographs. Secondary endpoints included investigator-rated degree of erythema, edema, crusting, exudation, percentage healing, improvement of skin quality, and patient satisfaction. RESULTS Nine patients completed the study. There was improvement of one degree in IGA for photodamage, pigmentation and wrinkles in all patients using the carboxytherapy gel mask at the one-week follow up. Blinded investigator ratings showed significant improvement of dryness, erythema, edema, crusting, and percentage healing at the 24-hour follow up, with all patients remaining the same a week post treatment. All patients in the carboxytherapy group were satisfied with the treatment and had no adverse effects. Three patients in the petroleum-based lanolin-containing group experienced mild edema and acne breakout that resolved two weeks after treatment. CONCLUSION Carboxytherapy delivered via a gel mask after skin rejuvenation procedures is a safe and effective strategy to improve clinical outcomes and reduce post-treatment side effects. J Drugs Dermatol. 20(4):461-465. doi:10.36849/JDD.5856.",2021,"Blinded investigator ratings showed significant improvement of dryness, erythema, edema, crusting, and percentage healing at the 24-hour follow up, with all patients remaining the same a week post treatment.",['Nine patients completed the study'],"['novel carboxytherapy gel mask compared with petroleum-based lanolin-containing ointment', 'carboxytherapy', 'carboxytherapy gel mask application right', 'Carboxytherapy Mask', 'nanofractional radiofrequency treatment']","['investigator-rated degree of erythema, edema, crusting, exudation, percentage healing, improvement of skin quality, and patient satisfaction', 'mild edema and acne breakout', 'degree of investigator global assessment (IGA) in photodamage, pigmentation, and wrinkles using standardized photographs', 'adverse effects', 'Facial Skin Quality and Photoaging', 'efficacy and patient satisfaction', 'dryness, erythema, edema, crusting, and percentage healing', 'Safety', 'IGA for photodamage, pigmentation and wrinkles']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0031264', 'cui_str': 'Petroleum'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023024', 'cui_str': 'Lanolin'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0205204', 'cui_str': 'Crust'}, {'cui': 'C0311437', 'cui_str': 'Exudation'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0222084', 'cui_str': 'Skin structure of face'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",10.0,0.0147001,"Blinded investigator ratings showed significant improvement of dryness, erythema, edema, crusting, and percentage healing at the 24-hour follow up, with all patients remaining the same a week post treatment.","[{'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Medrano', 'Affiliation': ''}, {'ForeName': 'Suleima', 'Initials': 'S', 'LastName': 'Arruda', 'Affiliation': ''}, {'ForeName': 'Namrata', 'Initials': 'N', 'LastName': 'Oza', 'Affiliation': ''}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Sadick', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.2021.5856'] 3652,33852248,Oral Sarecycline for Treatment of Papulopustular Rosacea: Results of a Pilot Study of Effectiveness and Safety.,"BACKGROUND Cutaneous rosacea is a common inflammatory skin disorder that often presents with facial papulopustular lesions that are frequently bothersome to patients. Studies have shown oral sarecycline to be effective and safe for acne, with a low risk of side effects that are historically associated with other tetracycline-class drugs such as doxycycline and minocycline, in addition to offering a reduced risk of emergence of resistant bacteria due to its narrow-spectrum of antibiotic activity. Oral sarecycline is FDA-approved for the treatment of acne (2018). OBJECTIVE A pilot study to evaluate the efficacy and safety of oral sarecycline in papulopustular rosacea. METHODS A 12-week, prospective, parallel-group, investigator-blinded, controlled pilot study was completed evaluating once-daily sarecycline, using weight-based oral dosing as recommended for acne vs control (multivitamin tablet), for the treatment of moderate-to-severe papulopustular rosacea in adult subjects (n=102), aged ≥18 years. The primary efficacy endpoint was Investigator’s Global score (IGA; clear or almost clear) and percent reduction in inflammatory lesion count at week 12. Safety and tolerability assessments were performed as well. RESULTS A total of 102 subjects were randomized; 97 completed the study. At week 12, IGA improvement was significantly greater for oral sarecycline when compared to the control (P<0.0001). Furthermore, absolute and percent reductions in inflammatory lesion counts were significantly greater in the sarecycline group for all weeks (4, 8, and 12) when compared to the control (P<0.001). Significant improvement in facial burning, erythema, and pruritus was reported in the sarecycline group, when compared to the control (P<0.05). No serious AEs were reported. CONCLUSION Sarecycline was effective, safe, and well-tolerated for treating papulopustular rosacea in adults with marked superiority in efficacy compared to subjects in the control group. With its narrow-spectrum activity, oral sarecycline may be a good option for the treatment of papulopustular rosacea. Additional studies are warranted to confirm the positive results of this pilot study.",2021,"RESULTS Sarecycline was shown to be effective and safe for the treatment of papulopustular rosacea in adults with marked superiority in efficacy as compared to subjects in the control group.","['papulopustular rosacea in adult subjects', 'Papulopustular Rosacea']","['doxycycline and minocycline', 'Sarecycline', 'Oral Sarecycline']",['effective and safe'],"[{'cui': 'C1449853', 'cui_str': 'Papulopustular rosacea'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C4519292', 'cui_str': 'Sarecycline'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.029565,"RESULTS Sarecycline was shown to be effective and safe for the treatment of papulopustular rosacea in adults with marked superiority in efficacy as compared to subjects in the control group.","[{'ForeName': 'James Q', 'Initials': 'JQ', 'LastName': 'Rosso', 'Affiliation': ''}, {'ForeName': 'Zoe Diana', 'Initials': 'ZD', 'LastName': 'Draelos', 'Affiliation': ''}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Effron', 'Affiliation': ''}, {'ForeName': 'Leon H', 'Initials': 'LH', 'LastName': 'Kircik', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.2021.5923'] 3653,33852247,Effect of Ixekizumab on Patient Reported Outcomes and Quality of Life in Patients With Moderate-to-Severe Plaque Psoriasis: 5-Year Results from the UNCOVER-1 and -2 Studies.,"OBJECTIVE We describe patient-reported outcomes and quality of life through 5 years of treatment in patients with moderate-to-severe plaque psoriasis in the UNCOVER-1 and -2 studies. METHODS This analysis included patients who were randomized to ixekizumab every 2 weeks then received ixekizumab every 4 weeks during the maintenance period, and who achieved static physician global assessment (0,1) at week 12, completed week 60, and entered the long-term extension period (weeks 60–264). Outcomes measures included responses in itch numeric rating scale (NRS), skin pain visual analog scale (VAS), and dermatology life quality index (DLQI) (0,1), and mean change from baseline in short form health survey (SF-36) mental (MCS) and physical component summaries (PCS), psoriasis skin appearance bothersomeness (PSAB), and work productivity activity impairment (WPAI). RESULTS At week 264 in UNCOVER-1 and -2, the observed itch NRS ≥4 responses were 82.4% and 93.1%, respectively, the itch NRS=0 responses were 51.7% and 58.5%, respectively, the skin pain VAS=0 responses were 59.3% and 63.1%, respectively, and the DLQI (0,1) responses were 75.0% and 88.1%, respectively. The observed mean changes from baseline at week 264 in UNCOVER-1 and UNCOVER-2 were 3.4 and 6.5, respectively, for SF-36 MCS, 4.4 and 4.8, respectively, for SF-36 PCS, and -21.3 and -22.0, respectively, for PSAB. WPAI psoriasis item scores improved from baseline in both UNCOVER-1 and -2. CONCLUSION Ixekizumab provided clinically meaningful and sustained improvements in itch, skin pain, DLQI, PSAB, SF-36 PCS, SF-36 MCS, and WPAI through 5 years of treatment in patients with moderate-to-severe plaque psoriasis. J Drugs Dermatol. 20(4):394-401. doi:10.36849/JDD.5821Visit the JDD Psoriasis Resource Center for more.",2021,"CONCLUSION Ixekizumab provided clinically meaningful and sustained improvements in itch, skin pain, DLQI, PSAB, SF-36 PCS, SF-36 MCS, and WPAI through 5 years of treatment in patients with moderate-to-severe plaque psoriasis.","['With Moderate-to-Severe Plaque Psoriasis', 'Patients', 'patients with moderate-to-severe plaque psoriasis', 'patients with moderate-to-severe plaque psoriasis in the UNCOVER-1 and -2 studies']","['Ixekizumab', 'ixekizumab']","['itch NRS=0 responses', 'responses in itch numeric rating scale (NRS), skin pain visual analog scale (VAS), and dermatology life quality index (DLQI) (0,1), and mean change from baseline in short form health survey (SF-36) mental (MCS) and physical component summaries (PCS), psoriasis skin appearance bothersomeness (PSAB), and work productivity activity impairment (WPAI', 'DLQI (0,1) responses', 'WPAI psoriasis item scores', 'Outcomes and Quality of Life', 'itch, skin pain, DLQI, PSAB, SF-36 PCS, SF-36 MCS, and WPAI', 'skin pain VAS=0 responses']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}]","[{'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0241136', 'cui_str': 'Pain of skin'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0559741', 'cui_str': 'Item score'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036221', 'cui_str': 'Mast cell sarcoma'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]",,0.100027,"CONCLUSION Ixekizumab provided clinically meaningful and sustained improvements in itch, skin pain, DLQI, PSAB, SF-36 PCS, SF-36 MCS, and WPAI through 5 years of treatment in patients with moderate-to-severe plaque psoriasis.","[{'ForeName': 'Melinda J', 'Initials': 'MJ', 'LastName': 'Gooderham', 'Affiliation': ''}, {'ForeName': 'Boni', 'Initials': 'B', 'LastName': 'Elewski', 'Affiliation': ''}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Augustin', 'Affiliation': ''}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Iversen', 'Affiliation': ''}, {'ForeName': 'Hideshi', 'Initials': 'H', 'LastName': 'Torii', 'Affiliation': ''}, {'ForeName': 'Russel', 'Initials': 'R', 'LastName': 'Burge', 'Affiliation': ''}, {'ForeName': 'Kyoungah', 'Initials': 'K', 'LastName': 'See', 'Affiliation': ''}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Gallo', 'Affiliation': ''}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Eastman', 'Affiliation': ''}, {'ForeName': 'Missy', 'Initials': 'M', 'LastName': 'McKean-Matthews', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Foley', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.2021.5821'] 3654,33852204,"Insulin Secretion is a Strong Predictor for Need of Insulin Therapy in Patients With New Onset Diabetes and HbA1c >10%, a post hoc analysis of EDICT study.","AIM To identify predictors of response to glucose lowering therapy in patients with new onset diabetes and very high HbA1c (>10%). RESEARCH DESIGN AND METHODS The study included EDICT participants with initial HbA1c >10% (N = 104). All subjects received a 75-g OGTT before initiation of therapy, and then were randomized to receive: (i) initial Triple Therapy with metformin, pioglitazone, and exenatide versus (ii) stepwise Conventional Therapy with metformin followed by glipizide and then glargine insulin to reduce A1c < 6.5%. Insulin secretion and insulin resistance were calculated with OGTT-derived indices. RESULTS 61% of participants in the Conventional Therapy group achieved HbA1c <6.5% at 6 months without need of insulin therapy compared to 78% in the Triple Therapy group (P=NS). Insulin secretion at baseline was the strongest predictor of subjects who did not require insulin therapy; a cut point of CPEP 120 /CPEP 0  > 1.7 predicted subjects who achieved the treatment target without insulin irrespective of the FPG concentration and whether or not they were started on Conventional or Triple Therapy. Subjects with CPEP 120 /CPEP 0  < 1.7 plus FPG ≤269 mg/dL (14.9 mmoL/L) also achieved the treatment goal with Triple Therapy. DISCUSSION Insulin secretion in response to a 75-g OGTT predicts the need for insulin therapy at the time of T2DM diagnosis. A cut point of 1.7 of CPEP 120 /CPEP 0 provides a useful clinical tool to individualize glucose lowering therapy in patients with new onset T2DM and HbA1c >10%. This article is protected by copyright. All rights reserved.",2021,Insulin secretion at baseline was the strongest predictor of subjects who did not require insulin therapy; a cut point of CPEP 120 /CPEP 0  ,"['EDICT participants with initial HbA1c >10% (N\xa0=\xa0104', '\u20091.7 predicted subjects who achieved the treatment target without insulin irrespective of the FPG concentration and whether or not they were started on Conventional or Triple Therapy', 'patients with new onset T2DM and HbA1c >10', 'Patients With New Onset Diabetes and HbA1c >10', 'Subjects with CPEP 120 /CPEP 0', 'subjects who did not require insulin therapy; a cut point of CPEP 120 /CPEP 0', 'patients with new onset diabetes and very high HbA1c (>10']","['FPG', 'glucose lowering therapy', 'metformin, pioglitazone, and exenatide versus (ii) stepwise Conventional Therapy with metformin followed by glipizide and then glargine insulin']","['Insulin secretion and insulin resistance', 'Insulin secretion']","[{'cui': 'C3280392', 'cui_str': 'EDICT syndrome'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0201945', 'cui_str': 'Protein electrophoresis, CSF'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0442804', 'cui_str': 'Very high'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0017642', 'cui_str': 'Glipizide'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}]",,0.0401569,Insulin secretion at baseline was the strongest predictor of subjects who did not require insulin therapy; a cut point of CPEP 120 /CPEP 0  ,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Abdelgani', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center and Texas Diabetes Institute, San Antonio, Texas.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Puckett', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center and Texas Diabetes Institute, San Antonio, Texas.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Adams', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center and Texas Diabetes Institute, San Antonio, Texas.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Triplitt', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center and Texas Diabetes Institute, San Antonio, Texas.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'DeFronzo', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center and Texas Diabetes Institute, San Antonio, Texas.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Abdul-Ghani', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center and Texas Diabetes Institute, San Antonio, Texas.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14383'] 3655,33852195,Acute ketosis inhibits appetite and decreases plasma concentrations of acyl ghrelin in healthy humans.,"CONTEXT Ketosis appears to decrease appetite and facilitate weight loss. Potential underlying mechanisms include decreases in plasma levels of the orexigenic hormone ghrelin and increases in appetite-inhibiting glucagon-like peptide-1 (GLP-1) levels. The effect of acute ketosis as compared to an isocaloric and isovolumetric beverage on both acyl ghrelin and total GLP-1 plasma concentrations has not been previously measured. OBJECTIVE We aimed to investigate the acute effect of ketone ester (KE) ingestion on appetite and plasma concentrations of acyl ghrelin (AG), unacylated ghrelin (UAG), and GLP-1 secretion and to compare responses to those elicited by isocaloric glucose administration. METHODS We examined ten healthy young males on three separate occasions using a placebo-controlled crossover design. INTERVENTIONS AND MAIN OUTCOME MEASURES A KE vs. taste-matched isovolumetric and isocaloric 50% glucose (GLU) and taste-matched isovolumetric placebo vehicle (PBO) was orally administered. Our main outcome measures were plasma concentrations of AG, UAG, glucose-dependent insulinotropic polypeptide (GIP), and GLP-1 along with appetite sensation scores assessed by visual analogue scale . RESULTS KE ingestion resulted in an average peak ꞵ-hydroxybutyrate concentration of 5.5 mM. AG and UAG were lowered by ~25% following both KE and GLU intake, compared with PBO. In the case of AG, the differences were - 52.1 [-79.4-24.8] for KE and - 48.4 [-75.4, -21.5] pg/mL for GLU intake, p < 0.01. Concentrations of AG remained lower with KE, but returned to baseline and were comparable with PBO levels after GLU intake. Neither GLP-1, GIP, gastrin or cholecystokinin were affected by KE ingestion. DISCUSSION Our results suggest that the suppressive effects on appetite sensation scores associated with hyperketonemia are more likely to be mediated through reduced ghrelin concentrations than by increased activity of cholecystokinin, gastrin, GIP, or GLP-1. This article is protected by copyright. All rights reserved.",2021,"Neither GLP-1, GIP, gastrin or cholecystokinin were affected by KE ingestion. ","['ten healthy young males', 'healthy humans']","['placebo', 'ketone ester (KE) ingestion']","['GLP-1, GIP, gastrin or cholecystokinin', 'average peak ꞵ-hydroxybutyrate concentration', 'appetite and facilitate weight loss', 'appetite sensation scores', 'PBO levels', 'activity of cholecystokinin, gastrin, GIP, or GLP-1', 'plasma concentrations of AG, UAG, glucose-dependent insulinotropic polypeptide (GIP), and GLP-1 along with appetite sensation scores assessed by visual analogue scale ', 'appetite and plasma concentrations of acyl ghrelin (AG), unacylated ghrelin (UAG), and GLP-1 secretion', 'Concentrations of AG']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0014898', 'cui_str': 'Ester'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0017151', 'cui_str': 'Gastrins'}, {'cui': 'C0008328', 'cui_str': 'Cholecystokinin'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0036536', 'cui_str': 'secretion'}]",10.0,0.158298,"Neither GLP-1, GIP, gastrin or cholecystokinin were affected by KE ingestion. ","[{'ForeName': 'Esben Thyssen', 'Initials': 'ET', 'LastName': 'Vestergaard', 'Affiliation': 'Department of Paediatrics, Regional Hospital Randers, DK, Randers, Denmark.'}, {'ForeName': 'Natasa Brkovic', 'Initials': 'NB', 'LastName': 'Zubanovic', 'Affiliation': 'Department of Internal Medicine, Clinic for Diabetes and Endocrinology, Viborg Regional Hospital, DK, Viborg, Denmark.'}, {'ForeName': 'Nikolaj', 'Initials': 'N', 'LastName': 'Rittig', 'Affiliation': 'Steno Diabetes Center Aarhus (SDCA), DK, Aarhus N, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Møller', 'Affiliation': 'Department and Laboratory of Internal Medicine and Endocrinology, MEA, Aarhus University Hospital, DK, Aarhus N, Denmark.'}, {'ForeName': 'Rune Ehrenreich', 'Initials': 'RE', 'LastName': 'Kuhre', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens F', 'Initials': 'JF', 'LastName': 'Rehfeld', 'Affiliation': 'Department of Clinical Biochemistry (KB3011), Rigshospitalet, Blegdamsvej 9, DK-2100, Copenhagen, Denmark.'}, {'ForeName': 'Henrik Holm', 'Initials': 'HH', 'LastName': 'Thomsen', 'Affiliation': 'Department of Internal Medicine, Clinic for Diabetes and Endocrinology, Viborg Regional Hospital, DK, Viborg, Denmark.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14402'] 3656,33852173,"The antiresorptive effect of GIP, but not GLP-2, is preserved in patients with hypoparathyroidism- a randomized crossover study.","Glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-2 (GLP-2) are gut hormones secreted postprandially. In healthy humans, both hormones decrease bone resorption accompanied by a rapid reduction in parathyroid hormone (PTH). The aim of this study was to investigate whether the changes in bone turnover after meal intake and after GIP- and GLP-2 injections, respectively, are mediated via a reduction in PTH secretion. This was tested in female patients with hypoparathyroidism given a standardized liquid mixed-meal test (n = 7) followed by a peptide injection-test (n = 4) using a randomized crossover design. We observed that the meal- and GIP-, but not the GLP-2-induced changes in bone turnover markers, were preserved in the patients with hypoparathyroidism. To understand the underlying mechanisms, we examined the expression of the GIP receptor (GIPR) and the GLP-2 receptor (GLP-2R) in human osteoblasts and osteoclasts as well as in parathyroid tissue. The GIPR was expressed in both human osteoclasts and osteoblasts, whereas the GLP-2R was absent or only weakly expressed in osteoclasts. Furthermore, both GIPR and GLP-2R were expressed in parathyroid tissue. Our findings suggest that the GIP-induced effect on bone turnover may be mediated directly via GIPR expressed in osteoblasts and osteoclasts and that this may occur independent of PTH. In contrast, the effect of GLP-2 on bone turnover seems to depend on changes in PTH and may be mediated through GLP-2R in the parathyroid gland.",2021,"The GIPR was expressed in both human osteoclasts and osteoblasts, whereas the GLP-2R was absent or only weakly expressed in osteoclasts.","['female patients with hypoparathyroidism given a standardized liquid mixed-meal test (n\xa0=\xa07) followed by a', 'patients with hypoparathyroidism']","['GLP-2', 'GIP- and GLP-2 injections', 'Glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-2 (GLP-2', 'peptide injection-test']",['bone turnover'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020626', 'cui_str': 'Hypoparathyroidism'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0912332', 'cui_str': 'Glucagon-like peptide 2'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0085268', 'cui_str': 'Bone remodeling'}]",,0.0243384,"The GIPR was expressed in both human osteoclasts and osteoblasts, whereas the GLP-2R was absent or only weakly expressed in osteoclasts.","[{'ForeName': 'Kirsa', 'Initials': 'K', 'LastName': 'Skov-Jeppesen', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, 2200, Copenhagen, Denmark.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Hepp', 'Affiliation': 'Department of Endocrinology, Hvidovre University Hospital, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Jannika', 'Initials': 'J', 'LastName': 'Oeke', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, 2200, Copenhagen, Denmark.'}, {'ForeName': 'Morten Steen', 'Initials': 'MS', 'LastName': 'Hansen', 'Affiliation': 'Molecular Endocrinology Unit (KMEB), Department of Endocrinology, Odense University Hospital, 5000, Odense, Denmark.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Jafari', 'Affiliation': 'Department of cellular and molecular medicine, Novo Nordisk Foundation Center for stem cell biology (Danstem), University of Copenhagen, 2200, Copenhagen, Denmark.'}, {'ForeName': 'Maria Saur', 'Initials': 'MS', 'LastName': 'Svane', 'Affiliation': 'Department of Endocrinology, Hvidovre University Hospital, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Nariman', 'Initials': 'N', 'LastName': 'Balenga', 'Affiliation': 'Division of General & Oncologic Surgery, Department of Surgery, Marlene and Stewart Greenebaum Comprehensive Cancer Center, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Olson', 'Affiliation': 'Division of General & Oncologic Surgery, Department of Surgery, Marlene and Stewart Greenebaum Comprehensive Cancer Center, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Frost', 'Affiliation': 'Molecular Endocrinology Unit (KMEB), Department of Endocrinology, Odense University Hospital, 5000, Odense, Denmark.'}, {'ForeName': 'Moustapha', 'Initials': 'M', 'LastName': 'Kassem', 'Affiliation': 'Molecular Endocrinology Unit (KMEB), Department of Endocrinology, Odense University Hospital, 5000, Odense, Denmark.'}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Madsbad', 'Affiliation': 'Department of Endocrinology, Hvidovre University Hospital, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Jens-Erik', 'Initials': 'JE', 'LastName': 'Beck Jensen', 'Affiliation': 'Department of Endocrinology, Hvidovre University Hospital, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Jens Juul', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, 2200, Copenhagen, Denmark.'}, {'ForeName': 'Mette Marie', 'Initials': 'MM', 'LastName': 'Rosenkilde', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, 2200, Copenhagen, Denmark.'}, {'ForeName': 'Bolette', 'Initials': 'B', 'LastName': 'Hartmann', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, 2200, Copenhagen, Denmark.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.4308'] 3657,33852164,"The effect of high-dose, short-term caffeine intake on the renal clearance of calcium, sodium and creatinine in healthy adults.","The consumption of caffeine has been linked to osteoporosis, believed to be due to enhanced bone resorption as a result of increased calcium excretion in the urine. However, the amount of calcium in the urine may not necessarily reflect the true effect of caffeine on calcium clearance. This study therefore examined the impact of high-dose, short-term caffeine intake on renal clearance of calcium, sodium and creatinine in healthy adults. In a double-blind clinical study, participants chewed caffeine (n=12) or placebo (n=12) gum for 5 min at 2-hour intervals over a 6-hour treatment period (800mg total caffeine). Caffeine increased renal calcium clearance by 77%. Furthermore, the effect was positively correlated with sodium clearance and urine volume, suggesting that caffeine may act through inhibition of sodium reabsorption in the proximal convoluted tubule. This study confirmed that caffeine does increase renal calcium clearance and fosters the further investigation into safe consumption of caffeine.",2021,Caffeine increased renal calcium clearance by 77%.,['healthy adults'],"['placebo', 'caffeine', 'Caffeine']","['calcium clearance', 'renal clearance of calcium, sodium and creatinine', 'renal calcium clearance']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0232813', 'cui_str': 'Renal clearance'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}]",,0.0421728,Caffeine increased renal calcium clearance by 77%.,"[{'ForeName': 'Stephanie E', 'Initials': 'SE', 'LastName': 'Reuter', 'Affiliation': 'UniSA Clinical & Health Sciences, University of South Australia, Adelaide, SA, Australia.'}, {'ForeName': 'Hayley B', 'Initials': 'HB', 'LastName': 'Schultz', 'Affiliation': 'UniSA Clinical & Health Sciences, University of South Australia, Adelaide, SA, Australia.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Ward', 'Affiliation': 'UniSA Clinical & Health Sciences, University of South Australia, Adelaide, SA, Australia.'}, {'ForeName': 'Crystal L', 'Initials': 'CL', 'LastName': 'Grant', 'Affiliation': 'Behaviour-Brain-Body Research Group, UniSA Justice & Society, University of South Australia, Adelaide, SA, Australia.'}, {'ForeName': 'Gemma M', 'Initials': 'GM', 'LastName': 'Paech', 'Affiliation': 'Behaviour-Brain-Body Research Group, UniSA Justice & Society, University of South Australia, Adelaide, SA, Australia.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Banks', 'Affiliation': 'Behaviour-Brain-Body Research Group, UniSA Justice & Society, University of South Australia, Adelaide, SA, Australia.'}, {'ForeName': 'Allan M', 'Initials': 'AM', 'LastName': 'Evans', 'Affiliation': 'UniSA Clinical & Health Sciences, University of South Australia, Adelaide, SA, Australia.'}]",British journal of clinical pharmacology,['10.1111/bcp.14856'] 3658,33852121,Randomized Phase II Trial of Capecitabine and Lapatinib with or without IMC-A12 (Cituxumumab) in Patients with HER2-Positive Advanced Breast Cancer Previously Treated with Trastuzumab and Chemotherapy: NCCTG N0733 (Alliance).,"PURPOSE To compare efficacy and safety of capecitabine and lapatinib with or without IMC-A12 (cituxumumab) in patients with HER2-positive metastatic breast cancer (MBC) previously treated with trastuzumab. PATIENTS AND METHODS Following an initial safety run-in cohort, patients were randomized 1:2 to Arm A (capecitabine and lapatinib) or to Arm B (capecitabine, lapatinib, and cituxumumab). Given the frequency of non-hematologic grade ≥ 3 adverse events in those receiving the three-drug combination in the safety cohort, lapatinib and capecitabine doses were reduced in Arm B only. The primary objective was to determine if the addition of cituxumumab to capecitabine and lapatinib improved progression-free survival (PFS) compared with capecitabine and lapatinib. Secondary objectives included a comparison between arms of other clinical endpoints, safety, change in overall quality of life (QOL) and self-assessed fatigue, rash, diarrhea, and hand-foot syndrome. RESULTS From July 2008 to March 2012, 68 patients (out of 142 planned) were enrolled and 63 were evaluable, including 8 for the safety run-in and 55 for the randomized cohort. Study enrollment was stopped early due to slow accrual. The addition of cituxumumab to capecitabine and lapatinib did not improve PFS (HR 0.93, 95% CI: 0.52-1.64). Furthermore, no difference in objective response rate or overall survival (OS) was observed. No difference between arms was observed in grade ≥ 3 adverse events, overall QOL change from baseline after 4 cycles of treatment. CONCLUSION The addition of cituxumumab to lapatinib and capecitabine did not improve PFS or OS compared with lapatinib and capecitabine in patients with HER2-positive MBC. CLINICAL TRIAL REGISTRY ClinicalTrials.gov Identifier: NCT00684983.",2021,"No difference between arms was observed in grade ≥ 3 adverse events, overall QOL change from baseline after 4 cycles of treatment. ","['patients with HER2-positive metastatic breast cancer (MBC', 'patients with HER2-positive MBC', 'Patients with HER2-Positive Advanced Breast Cancer', 'From July 2008 to March 2012, 68 patients (out of 142 planned) were enrolled and 63 were evaluable, including 8 for the safety run-in and 55 for the randomized cohort']","['lapatinib and capecitabine', 'trastuzumab', 'Trastuzumab and Chemotherapy', 'capecitabine and lapatinib with or without IMC-A12 (cituxumumab', 'capecitabine and lapatinib', 'Capecitabine and Lapatinib with or without IMC-A12 (Cituxumumab', 'cituxumumab to lapatinib and capecitabine', 'capecitabine and lapatinib) or to Arm B (capecitabine, lapatinib, and cituxumumab']","['PFS or OS', 'grade\u2009≥\u20093 adverse events, overall QOL change', 'PFS', 'objective response rate or overall survival (OS', 'frequency of non-hematologic grade\u2009≥\u20093 adverse events', 'progression-free survival (PFS', 'safety, change in overall quality of life (QOL) and self-assessed fatigue, rash, diarrhea, and hand-foot syndrome']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721209', 'cui_str': 'Metastatic human epidermal growth factor 2 positive carcinoma of breast'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2703174', 'cui_str': 'IMC-A12'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}]",,0.172243,"No difference between arms was observed in grade ≥ 3 adverse events, overall QOL change from baseline after 4 cycles of treatment. ","[{'ForeName': 'Tufia C', 'Initials': 'TC', 'LastName': 'Haddad', 'Affiliation': 'Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA. Haddad.Tufia@mayo.edu.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Alliance Statistics and Data Management Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Ciara C', 'Initials': 'CC', 'LastName': ""O'Sullivan"", 'Affiliation': 'Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Beiyun', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Northfelt', 'Affiliation': 'Mayo Clinic, Scottsdale, AZ, USA.'}, {'ForeName': 'Amylou C', 'Initials': 'AC', 'LastName': 'Dueck', 'Affiliation': 'Mayo Clinic, Scottsdale, AZ, USA.'}, {'ForeName': 'Karla V', 'Initials': 'KV', 'LastName': 'Ballman', 'Affiliation': 'Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Kathleen S', 'Initials': 'KS', 'LastName': 'Tenner', 'Affiliation': 'Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Linden', 'Affiliation': 'Seattle Cancer Care Alliance, Seattle, WA, USA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Sparano', 'Affiliation': 'Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Judith O', 'Initials': 'JO', 'LastName': 'Hopkins', 'Affiliation': 'Southeast Clinical Oncology Research (SCOR) Consortium, Winston-Salem, NC, USA.'}, {'ForeName': 'Chamath', 'Initials': 'C', 'LastName': 'De Silva', 'Affiliation': 'Kaiser Permanente-Rock Creek, Lafayette, CO, USA.'}, {'ForeName': 'Edith A', 'Initials': 'EA', 'LastName': 'Perez', 'Affiliation': 'Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Haluska', 'Affiliation': 'Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Goetz', 'Affiliation': 'Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA.'}]",Breast cancer research and treatment,['10.1007/s10549-021-06221-8'] 3659,33841437,"Single-Arm, Multicenter Phase I/II Clinical Trial for the Treatment of Envenomings by Massive Africanized Honey Bee Stings Using the Unique Apilic Antivenom.","We evaluated the safety, optimal dose, and preliminary effectiveness of a new-approach Africanized honeybee ( Apis mellifera ) Antivenom (AAV) in a phase I/II, multicenter, non-randomized, single-arm clinical trial involving 20 participants with multiple stings. Participants received 2 to 10 vials of AAV depending on the number of stings they suffered, or a predefined adjuvant, symptomatic, and complementary treatment. The primary safety endpoint was the occurrence of early adverse reactions within the first 24 h of treatment. Preliminary efficacy based on clinical evolution, including laboratory findings, was assessed at baseline and at various time points over the four following weeks. ELISA assays and mass spectrometry were used to estimate venom pharmacokinetics before, during, and after treatment. Twenty adult participants, i.e., 13 (65%) men and 7 (35%) women, with a median age of 44 years and a mean body surface area of 1.92 m 2 (median = 1.93 m 2 ) were recruited. The number of stings ranged from 7 to > 2,000, with a median of 52.5. Symptoms of envenoming were classified as mild, moderate, or severe in 80% (16), 15% (3), and 5% (1) of patients, respectively; patients with mild, moderate, or severe envenoming received 2, 6, and 10 vials of AAV as per the protocol. None of the patients had late reactions (serum sickness) within 30 d of treatment. There was no discontinuation of the protocol due to adverse events, and there were no serious adverse events. One patient had a moderate adverse event, transient itchy skin, and erythroderma. All participants completed the intravenous antivenom infusion within 2 h, and there was no loss to follow-up after discharge. ELISA assays showed venom (melittin and PLA 2 ) concentrations varying between 0.25 and 1.479 ng/mL prior to treatment. Venom levels decreased in all patients during the hospitalization period. Surprisingly, in nine cases (45%), despite clinical recovery and the absence of symptoms, venom levels increased again during outpatient care 10 d after discharge. Mass spectrometry showed melittin in eight participants, 30 d after treatment. Considering the promising safety results for this investigational product in the treatment of massive Africanized honeybee attack, and its efficacy, reflected in the clinical improvements and corresponding immediate decrease in blood venom levels, the AAV has shown to be safe for human use. Clinical Trial Registration: UTN: U1111-1160-7011, identifier [RBR-3fthf8].",2021,ELISA assays showed venom (melittin and PLA 2 ) concentrations varying between 0.25 and 1.479 ng/mL prior to treatment.,"['20 participants with multiple stings', 'Twenty adult participants, i.e., 13 (65%) men and 7 (35%) women, with a median age of 44 years and a mean body surface area of 1.92 m 2 (median = 1.93 m 2 ) were recruited']","['UTN', 'new-approach Africanized honeybee ( Apis mellifera ) Antivenom (AAV']","['late reactions (serum sickness', 'number of stings', 'moderate adverse event, transient itchy skin, and erythroderma', 'Venom levels', 'occurrence of early adverse reactions']","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0038340', 'cui_str': 'Sting'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0323351', 'cui_str': 'Apis mellifera'}, {'cui': 'C0003450', 'cui_str': 'Antivenom-containing product'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0036830', 'cui_str': 'Serum rash'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0038340', 'cui_str': 'Sting'}, {'cui': 'C1513374', 'cui_str': 'Common terminology criteria for adverse events grade 2'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0011606', 'cui_str': 'Erythroderma'}, {'cui': 'C0042479', 'cui_str': 'Venom'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",20.0,0.135336,ELISA assays showed venom (melittin and PLA 2 ) concentrations varying between 0.25 and 1.479 ng/mL prior to treatment.,"[{'ForeName': 'Alexandre Naime', 'Initials': 'AN', 'LastName': 'Barbosa', 'Affiliation': 'Department of Infectology, Dermatology, Imaging Diagnosis and Radiotherapy, Botucatu Medical School (FMB), São Paulo State University (UNESP - Univ Estadual Paulista), Botucatu, Brazil.'}, {'ForeName': 'Rui Seabra', 'Initials': 'RS', 'LastName': 'Ferreira', 'Affiliation': 'Department of Infectology, Dermatology, Imaging Diagnosis and Radiotherapy, Botucatu Medical School (FMB), São Paulo State University (UNESP - Univ Estadual Paulista), Botucatu, Brazil.'}, {'ForeName': 'Francilene Capel Tavares', 'Initials': 'FCT', 'LastName': 'de Carvalho', 'Affiliation': 'Graduate Program in Tropical Diseases, Botucatu Medical School (FMB), São Paulo State University (UNESP-Univ Estadual Paulista), Botucatu, Brazil.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Schuelter-Trevisol', 'Affiliation': 'Clinical Research Center, Nossa Senhora da Conceição Hospital, Tubarão, Brazil.'}, {'ForeName': 'Mônica Bannwart', 'Initials': 'MB', 'LastName': 'Mendes', 'Affiliation': 'Department of Infectology, Dermatology, Imaging Diagnosis and Radiotherapy, Botucatu Medical School (FMB), São Paulo State University (UNESP - Univ Estadual Paulista), Botucatu, Brazil.'}, {'ForeName': 'Bruna Cavecci', 'Initials': 'BC', 'LastName': 'Mendonça', 'Affiliation': 'Graduate Program in Tropical Diseases, Botucatu Medical School (FMB), São Paulo State University (UNESP-Univ Estadual Paulista), Botucatu, Brazil.'}, {'ForeName': 'José Nixon', 'Initials': 'JN', 'LastName': 'Batista', 'Affiliation': 'Clinical Research Center, Nossa Senhora da Conceição Hospital, Tubarão, Brazil.'}, {'ForeName': 'Daisson José', 'Initials': 'DJ', 'LastName': 'Trevisol', 'Affiliation': 'Clinical Research Center, Nossa Senhora da Conceição Hospital, Tubarão, Brazil.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Boyer', 'Affiliation': 'VIPER Institute, University of Arizona College of Medicine, Tucson, AZ, United States.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Chippaux', 'Affiliation': 'MERIT, IRD, Université Paris 5, Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Natália Bronzatto', 'Initials': 'NB', 'LastName': 'Medolago', 'Affiliation': 'Clinical Research Unit (UPECLIN), Botucatu Medical School, São Paulo State University (UNESP-Univ Estadual Paulista), Botucatu, Brazil.'}, {'ForeName': 'Claudia Vilalva', 'Initials': 'CV', 'LastName': 'Cassaro', 'Affiliation': 'Graduate Program in Tropical Diseases, Botucatu Medical School (FMB), São Paulo State University (UNESP-Univ Estadual Paulista), Botucatu, Brazil.'}, {'ForeName': 'Márcia Tonin Rigotto', 'Initials': 'MTR', 'LastName': 'Carneiro', 'Affiliation': 'Clinical Research Unit (UPECLIN), Botucatu Medical School, São Paulo State University (UNESP-Univ Estadual Paulista), Botucatu, Brazil.'}, {'ForeName': 'Ana Paola Piloto', 'Initials': 'APP', 'LastName': 'de Oliveira', 'Affiliation': 'Clinical Research Unit (UPECLIN), Botucatu Medical School, São Paulo State University (UNESP-Univ Estadual Paulista), Botucatu, Brazil.'}, {'ForeName': 'Daniel Carvalho', 'Initials': 'DC', 'LastName': 'Pimenta', 'Affiliation': 'Graduate Program in Tropical Diseases, Botucatu Medical School (FMB), São Paulo State University (UNESP-Univ Estadual Paulista), Botucatu, Brazil.'}, {'ForeName': 'Luís Eduardo Ribeiro', 'Initials': 'LER', 'LastName': 'da Cunha', 'Affiliation': 'Antivenom Production Laboratory, Vital Brazil Institute, Rio de Janeiro, Brazil.'}, {'ForeName': 'Lucilene Delazari', 'Initials': 'LD', 'LastName': 'Dos Santos', 'Affiliation': 'Department of Infectology, Dermatology, Imaging Diagnosis and Radiotherapy, Botucatu Medical School (FMB), São Paulo State University (UNESP - Univ Estadual Paulista), Botucatu, Brazil.'}, {'ForeName': 'Benedito', 'Initials': 'B', 'LastName': 'Barraviera', 'Affiliation': 'Department of Infectology, Dermatology, Imaging Diagnosis and Radiotherapy, Botucatu Medical School (FMB), São Paulo State University (UNESP - Univ Estadual Paulista), Botucatu, Brazil.'}]",Frontiers in immunology,['10.3389/fimmu.2021.653151'] 3660,33841131,"Antiretroviral Long-Term Efficacy and Resistance of Lopinavir/Ritonavir Plus Lamivudine in HIV-1-Infected Treatment-Naïve Patients (ALTERLL): 144-Week Results of a Randomized, Open-Label, Non-Inferiority Study From Guangdong, China.","Dual therapy with lopinavir/ritonavir (LPV/r) plus lamivudine (3TC) has been demonstrated to be non-inferior to the triple drug regimen including LPV/r plus two nucleoside reverse transcriptase inhibitors (NRTIs) in 48-week studies. However, little is known about the long-term efficacy and drug resistance of this simplified strategy. A randomized, controlled, open-label, non-inferiority trial (ALTERLL) was conducted to assess the efficacy, drug resistance, and safety of dual therapy with LPV/r plus 3TC (DT group), compared with the first-line triple-therapy regimen containing tenofovir (TDF), 3TC plus efavirenz (EFV) (TT group) in antiretroviral therapy (ART)-naïve HIV-1-infected adults in Guangdong, China. The primary endpoint was the proportion of patients with plasma HIV-1 RNA < 50 copies/ml at week 144. Between March 1 and December 31, 2015, a total of 196 patients (from 274 patients screened) were included and randomly assigned to either the DT group (n = 99) or the TT group (n = 97). In the primary intention-to-treat (ITT) analysis at week 144, 95 patients (96%) in the DT group and 93 patients (95.9%) in the TT group achieved virological inhibition with plasma HIV-1 RNA <50 copies/ml (difference: 0.1%; 95% CI, -4.6-4.7%), meeting the criteria for non-inferiority. The DT group did not show significant differences in the mean increase in CD4 + cell count (247.0 vs. 204.5 cells/mm 3 ; p = 0.074) or the CD4/CD8 ratio (0.47 vs. 0.49; p = 0.947) from baseline, or the inflammatory biomarker levels through week 144 compared with the TT group. For the subgroup analysis, baseline high viremia (HIV-1 RNA > 100,000 copies/ml) and genotype BC did not affect the primary endpoint or the mean increase in CD4 + cell count or CD4/CD8 ratio from baseline at week 144. However, in patients with genotype AE, the DT group showed a higher mean increase in CD4 + cell count from baseline through 144 weeks than the TT group (308.7 vs. 209.4 cells/mm 3 ; p = 0.038). No secondary HIV resistance was observed in either group. Moreover, no severe adverse event (SAE) or death was observed in any group. Nonetheless, more patients in the TT group (6.1%) discontinued the assigned regimen than those in the DT group (1%) due to adverse events. Dual therapy with LPV/r plus 3TC manifests long-term non-inferior therapeutic efficacy, low drug resistance, good safety, and tolerability compared with the first-line triple-therapy regimen in Guangdong, China, indicating dual therapy is a viable alternative in resource-limited areas. Clinical Trial Registration: [http://www.chictr.org.cn], identifier [ChiCTR1900024611].",2020,"p = 0.947) from baseline, or the inflammatory biomarker levels through week 144 compared with the TT group.","['HIV-1-Infected Treatment-Naïve Patients (ALTERLL', 'ART)-naïve HIV-1-infected adults in Guangdong, China', 'Between March 1 and December 31, 2015, a total of 196 patients (from 274 patients screened']","['LPV/r plus 3TC (DT group', 'tenofovir (TDF), 3TC plus efavirenz (EFV) (TT group) in antiretroviral therapy', 'lopinavir/ritonavir (LPV/r) plus lamivudine (3TC', 'LPV/r plus 3TC', 'Lopinavir/Ritonavir Plus Lamivudine']","['severe adverse event (SAE) or death', 'proportion of patients with plasma HIV-1 RNA', 'CD4/CD8 ratio', 'efficacy, drug resistance, and safety', 'CD4 + cell count', 'CD4 + cell count or CD4/CD8 ratio', 'adverse events', 'virological inhibition', 'inflammatory biomarker levels', 'secondary HIV resistance', 'mean increase in CD4 + cell count']","[{'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0013203', 'cui_str': 'Drug resistance'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",196.0,0.266703,"p = 0.947) from baseline, or the inflammatory biomarker levels through week 144 compared with the TT group.","[{'ForeName': 'Peng-Le', 'Initials': 'PL', 'LastName': 'Guo', 'Affiliation': ""Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Hao-Lan', 'Initials': 'HL', 'LastName': 'He', 'Affiliation': ""Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Xie-Jie', 'Initials': 'XJ', 'LastName': 'Chen', 'Affiliation': ""Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Jin-Feng', 'Initials': 'JF', 'LastName': 'Chen', 'Affiliation': ""Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Xiao-Ting', 'Initials': 'XT', 'LastName': 'Chen', 'Affiliation': ""Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Lan', 'Affiliation': ""Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Pei-Shan', 'Initials': 'PS', 'LastName': 'Du', 'Affiliation': ""Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Huo-Lin', 'Initials': 'HL', 'LastName': 'Zhong', 'Affiliation': ""Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': ""Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Li-Ya', 'Initials': 'LY', 'LastName': 'Li', 'Affiliation': ""Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Feng-Yu', 'Initials': 'FY', 'LastName': 'Hu', 'Affiliation': ""Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Xiao-Ping', 'Initials': 'XP', 'LastName': 'Tang', 'Affiliation': ""Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Wei-Ping', 'Initials': 'WP', 'LastName': 'Cai', 'Affiliation': ""Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Ling-Hua', 'Initials': 'LH', 'LastName': 'Li', 'Affiliation': ""Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, China.""}]",Frontiers in pharmacology,['10.3389/fphar.2020.569766'] 3661,33840978,Effect of Yogasana Intervention on Standing Balance Performance among People with Diabetic Peripheral Neuropathy: A Pilot Study.,"Background Diabetic peripheral neuropathy (DPN) is known to cause impaired balance and eventually increased risk of fall. Yogasanas characterized by slow, gentle transitions into postures with a varying base of support and focus on body awareness during movement hold potential for training balance control. Therefore, the current study aimed to evaluate effect of structured Yogasana intervention compared to conventional balance exercise on static and dynamic balance performance among people with diabetic neuropathy. Methods : Thirty-five people with DPN aged 42-70 years were recruited to Yogasana intervention group ( n = 11), conventional balance exercises group ( n = 10), and Control group ( n = 14) following ethical approval. All participants were evaluated at baseline and post 12-week intervention on star excursion balance test, single-limb stance test, and center of pressure (CoP) excursion for balance performance, Modified fall efficacy scale for fear of falls and lower extremity strength using chair stand test and step-up test. Results Balance performance (static and dynamic measured by star excursion balance test, single-limb stance test, and CoP excursion, lower extremity strength (using chair stand test and step-up test) demonstrated improvement and fear of fall reduced among Yogasana intervention group ( p = 0.05) and conventional balance exercises group ( p = 0.05) post 12-week intervention. CoP excursion increased in the control group indicating deterioration in balance performance after 12 weeks ( p = 0.05). Post hoc comparison revealed that Yogasana intervention was marginally more effective in improving static and dynamic balance performance compared to conventional balance exercises in all variables of standing balance performance ( p = 0.025). Conclusion Yogasana and conventional balance exercises were effective in improving static and dynamic balance performance, lower extremity muscle strength, and reducing fear of fall among people with DPN. Yogasana intervention demonstrated marginally greater improvement in static and dynamic balance performance and lower extremity muscle strength compared to conventional exercise.",2021,Yogasana intervention demonstrated marginally greater improvement in static and dynamic balance performance and lower extremity muscle strength compared to conventional exercise.,"['people with diabetic neuropathy', 'Thirty-five people with DPN aged 42-70 years', 'People with Diabetic Peripheral Neuropathy']","['conventional balance exercise', 'structured Yogasana intervention', 'Yogasana intervention', 'Yogasana and conventional balance exercises', 'Yogasana Intervention', 'conventional balance exercises']","['balance performance', 'star excursion balance test, single-limb stance test, and center of pressure (CoP) excursion for balance performance, Modified fall efficacy scale for fear of falls and lower extremity strength using chair stand test and step-up test', 'static and dynamic balance performance', 'Standing Balance Performance', 'Balance performance (static and dynamic measured by star excursion balance test, single-limb stance test, and CoP excursion, lower extremity strength (using chair stand test and step-up test) demonstrated improvement and fear of fall', 'CoP excursion', 'standing balance performance', 'static and dynamic balance performance and lower extremity muscle strength', 'static and dynamic balance performance, lower extremity muscle strength']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011882', 'cui_str': 'Diabetic neuropathy'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0740447', 'cui_str': 'Diabetic peripheral neuropathy'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0454366', 'cui_str': 'Step ups'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0056471', 'cui_str': 'creatinolfosfate'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",,0.0115308,Yogasana intervention demonstrated marginally greater improvement in static and dynamic balance performance and lower extremity muscle strength compared to conventional exercise.,"[{'ForeName': 'Jinny P', 'Initials': 'JP', 'LastName': 'Kanjirathingal', 'Affiliation': 'Department of Musculoskeletal Physiotherapy, MGM School of Physiotherapy, MGM Institute of Health Sciences, Navi Mumbai, Maharashtra, India.'}, {'ForeName': 'Rajani P', 'Initials': 'RP', 'LastName': 'Mullerpatan', 'Affiliation': 'MGM Centre of Human Movement Science, MGM School of Physiotherapy, MGM Institute of Health Sciences, Navi Mumbai, Maharashtra, India.'}, {'ForeName': 'Girish', 'Initials': 'G', 'LastName': 'Nehete', 'Affiliation': 'Department of Musculoskeletal Physiotherapy, MGM School of Physiotherapy, MGM Institute of Health Sciences, Navi Mumbai, Maharashtra, India.'}, {'ForeName': 'Nagarathna', 'Initials': 'N', 'LastName': 'Raghuram', 'Affiliation': 'Medical Director, Vivekanada Yoga Anusandhana Samasthana, Bengaluru, Karnataka, India.'}]",International journal of yoga,['10.4103/ijoy.IJOY_75_20'] 3662,33840531,"Effect of light-emitting diode-mediated photobiomodulation on extraction space closure in adolescents and young adults: A split-mouth, randomized controlled trial.","INTRODUCTION This split-mouth trial aimed to examine the effects of light-emitting diode (LED)-mediated photobiomodulation compared with no photobiomodulation on maxillary canine distalization. METHODS Twenty participants (10 males and 10 females; aged 11-20 years) requiring bilateral extraction of maxillary first premolars were included from the Sydney Dental Hospital waiting list. After premolar extractions, leveling, and alignment, canines were retracted on 0.020-in stainless steel wires with coil springs delivering 150 g of force to each side. Each patient's right side was randomly assigned to experimental or control using www.randomisation.com, and allocation concealment was performed with sequentially numbered, opaque, sealed envelopes. The experimental side received 850 nm wavelength, 60 mW/cm 2 power, continuous LED with OrthoPulse device (Biolux Research Ltd, Vancouver, British Columbia, Canada) for 5 min/d. For the control side, the device was blocked with opaque black film. Patients were reviewed at 4-week intervals for force reactivation and intraoral scanning over 12 weeks. The primary outcome was the amount of tooth movement, and secondary outcomes were anchorage loss and canine rotation, all measured digitally. Blinding for study participants and the treating clinician was not possible; however, blinding was done for the measurements by deidentifying the digital scans. Linear mixed models were implemented for the data analysis. RESULTS Nineteen participants concluded the study. Data analysis showed that the treatment × time interaction was not significant, suggesting no difference in space closure (unstandardized regression coefficient [b], 0.12; 95% confidence interval [CI], -0.05 to 0.29; P = 0.17), canine rotation (b, 0.21; 95% CI, -0.82 to 1.25; P = 0.69), and anchorage loss (b, -0.01, 95% CI, -0.28 to 0.26, P = 0.94). No harms were noted. CONCLUSIONS Daily 5-minute application of LED did not result in clinically meaningful differences during extraction space closure compared with no LED application. REGISTRATION Australian New Zealand Clinical Trials Registry (ACTRN12616000652471). PROTOCOL The protocol was not published before trial commencement. FUNDING This research was funded by the Australian Society of Orthodontists Foundation for Research and Education.",2021,"CONCLUSIONS Daily 5-minute application of LED did not result in clinically meaningful differences during extraction space closure compared with no LED application. ","['adolescents and young adults', 'Nineteen participants concluded the study', 'Twenty participants (10 males and 10 females; aged 11-20\xa0years) requiring\xa0bilateral extraction of maxillary first premolars were included from the Sydney Dental Hospital waiting list']","['light-emitting diode (LED)-mediated photobiomodulation', 'light-emitting diode-mediated photobiomodulation']","['extraction space closure', 'anchorage loss', 'space closure (unstandardized regression coefficient', 'canine rotation', 'amount of tooth movement, and secondary outcomes were anchorage loss and canine rotation, all measured digitally']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0917903', 'cui_str': 'Conclude Composite Resin'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3164440', 'cui_str': 'Dental hospital'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0162676', 'cui_str': 'Enzyme-multiplied immunoassay technique'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}]","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0040446', 'cui_str': 'Orthodontic Tooth Movement'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",19.0,0.405531,"CONCLUSIONS Daily 5-minute application of LED did not result in clinically meaningful differences during extraction space closure compared with no LED application. ","[{'ForeName': 'Safa', 'Initials': 'S', 'LastName': 'Al-Shafi', 'Affiliation': 'Discipline of Orthodontics and Paediatric Dentistry, School of Dentistry, Faculty of Medicine and Health, The University of Sydney, Department of Orthodontics, Sydney Dental Hospital, Sydney South Local Health District, Australia.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Pandis', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopedics, School of Dentistry, University of Bern, Bern, Switzerland.'}, {'ForeName': 'M Ali', 'Initials': 'MA', 'LastName': 'Darendeliler', 'Affiliation': 'Discipline of Orthodontics and Paediatric Dentistry, School of Dentistry, Faculty of Medicine and Health, The University of Sydney, Department of Orthodontics, Sydney Dental Hospital, Sydney South Local Health District, Australia.'}, {'ForeName': 'Alexandra K', 'Initials': 'AK', 'LastName': 'Papadopoulou', 'Affiliation': 'Discipline of Orthodontics and Paediatric Dentistry, School of Dentistry, Faculty of Medicine and Health, The University of Sydney, Department of Orthodontics, Sydney Dental Hospital, Sydney South Local Health District, Australia. Electronic address: alexandra.papadopoulou@sydney.edu.au.'}]","American journal of orthodontics and dentofacial orthopedics : official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics",['10.1016/j.ajodo.2020.12.021'] 3663,33840495,[Contribution of respiratory relaxation techniques during intravitreal injections: A pilot study].,"PURPOSE To study the effects of breathing techniques for anxiety, perceived pain, and patient satisfaction while receiving intravitreal injections. METHOD This prospective, randomized clinical study included patients admitted for intravitreal anti-VEGF injections. They were randomized into two groups: a relaxation group who listened to a prerecorded relaxation breathing session before and during the injection, and a control group who received the injection without a relaxation session. Statistical analysis was then performed to assess the factors influencing satisfaction, anxiety, and perceived pain. RESULTS We included one-hundred four patients in total: 52 in the relaxation group versus 52 in the control group. The relaxation group had a greater decrease in anxiety than the control group (P=0.03) but similar levels of pain (P=0.86). In total, 80.76% of patients in the relaxation group expressed the wish to have a relaxation session during their next injection. Multivariate analysis showed that the patient's usual level of stress as well as the relaxation session affected the level of anxiety experienced before the injection. CONCLUSION Relaxation techniques before and during intravitreal injections decrease anxiety in patients without decreasing pain during IVT. Prerecorded relaxation breathing sessions are non-invasive, inexpensive, easy to set up, and reduce anxiety during intravitreal injections on an outpatient basis.",2021,The relaxation group had a greater decrease in anxiety than the control group (P=0.03) but similar levels of pain (P=0.86).,"['patients admitted for', 'one-hundred four patients in total: 52 in the relaxation group versus 52 in the control group', 'patients without decreasing pain during IVT']","['intravitreal anti-VEGF injections', 'relaxation group who listened to a prerecorded relaxation breathing session', 'control group who received the injection without a relaxation session', 'Prerecorded relaxation breathing sessions', 'respiratory relaxation techniques', 'intravitreal injections']","['anxiety, perceived pain, and patient satisfaction', 'pain', 'satisfaction, anxiety, and perceived pain', 'anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035029', 'cui_str': 'Relaxation technique'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",104.0,0.00619345,The relaxation group had a greater decrease in anxiety than the control group (P=0.03) but similar levels of pain (P=0.86).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ouadfel', 'Affiliation': ""Service de chirurgie ambulatoire, centre hospitalier d'Avranches-Granville, Granville, France; Service d'ophtalmologie, CHU d'Oujda, Université Mohammed-VI, Oujda, Maroc.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'El Sanharawi', 'Affiliation': ""Service d'ophtalmologie, centre hospitalier intercommunal de Villeneuve Saint-Georges, Villeneuve-Saint-Georges, France; Unité de dépistage et de chirurgie ophtalmologique, centre hospitalier de Châteaudun, Châteaudun, France.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Tahiri Joutei Hassani', 'Affiliation': ""Service de chirurgie ambulatoire, centre hospitalier d'Avranches-Granville, Granville, France. Electronic address: tjhr78@hotmail.com.""}]",Journal francais d'ophtalmologie,['10.1016/j.jfo.2020.09.028'] 3664,33840068,Effect of Group Patient Education on Glycemic Control Among People Living with Type 2 Diabetes in Vietnam: A Randomized Controlled Single-Center Trial.,"INTRODUCTION In low- to middle-income countries such as Vietnam, urgent measures are required to prevent and control type 2 diabetes and its complications. This study measured the effect of a 3-month patient education and self-management intervention in a low-resource setting on diabetes knowledge and levels of blood glucose control. METHODS This was a single-center randomized controlled study among adult outpatients with type 2 diabetes. Patients were randomly assigned to 3-month community intervention consisting of group education for type 2 diabetes knowledge, diet, exercise in combination with usual diabetes care, or to usual diabetes care alone (control). Diabetes knowledge was measured with a modified Michigan University Diabetes Knowledge Test (MDKT). Other study outcomes included change in mean HbA1c, fasting blood glucose (FBG), and systolic blood pressure (SBP). RESULTS A total of 364 patients were randomized, 182 to the intervention group and 182 to control. The two groups were similar regarding main baseline characteristics. The male/female ratio was 45.1%/54.9% and mean age was 62.2 ± 9.3 years. Approximately half the patients (48.1%) were overweight and 15.7% were obese, mean baseline HbA1c was 8.21 ± 1.92%, and only 29.9% of participants had a baseline HbA1c < 7.0%. At baseline, diabetes knowledge was ""very poor"" or ""poor"" in 63.7% of patients. After a 3-month follow-up, the proportion achieving the target MDKT score increased from 37.4% to 81.3% in the intervention group and from 35.2% to 51.7% in the control (between-group difference P < 0.001). The estimate (SD) of the difference between intervention and control groups was - 1.63 (2.16), 95% CI - 2.07 to - 1.18. Mean changes from baseline HbA1c were - 0.54 ± 1.41% and - 0.18 ± 1.33% in the intervention and control groups, respectively (P = 0.012). Among those with poor glycemic control (HbA1c ≥ 7%) at baseline, mean changes at 3 months were - 0.80 ± 1.52% vs 0.41 ± 1.47%, respectively, (P = 0.013). Statistically significant decreases in FBG and SBP were also observed in the intervention group at 3 months, but not in the control group. Multivariate analysis revealed the variables with the strongest influence on blood glucose control at 3 months were study group, baseline MDKT score, diabetes duration, and baseline HbA1c (all P ≤ 0.05). CONCLUSION Provision of a structured educational program to Vietnamese people living with type 2 diabetes is effective at improving disease knowledge and is associated with better glycemic control. Larger and longer-term studies are now warranted to confirm these findings. TRIAL REGISTRATION This trial was retrospectively registered on 27 May 2020 through the https://clinicaltrials.gov site with the following identifier: NCT04403841.",2021,"Statistically significant decreases in FBG and SBP were also observed in the intervention group at 3 months, but not in the control group.","['27 May 2020 through the https://clinicaltrials.gov site with the following identifier:\xa0NCT04403841', 'People Living with Type\xa02 Diabetes in Vietnam', 'Vietnamese people living with type\xa02 diabetes', '364 patients were randomized, 182 to the intervention group and 182 to control', 'male/female ratio was 45.1%/54.9% and mean age was 62.2\u2009±\u20099.3\xa0years', 'adult outpatients with type\xa02 diabetes']","['community intervention consisting of group education for type\xa02 diabetes knowledge, diet, exercise in combination with usual diabetes care, or to usual diabetes care alone (control', 'patient education and self-management intervention', 'Provision of a structured educational program']","['change in mean HbA1c, fasting blood glucose (FBG), and systolic blood pressure (SBP', 'FBG and SBP', 'baseline MDKT score, diabetes duration, and baseline HbA1c', 'diabetes knowledge and levels of blood glucose control', 'Glycemic Control', 'blood glucose control', 'target MDKT score']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0150375', 'cui_str': 'Group education'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",364.0,0.0635082,"Statistically significant decreases in FBG and SBP were also observed in the intervention group at 3 months, but not in the control group.","[{'ForeName': 'Ho Thi Kim', 'Initials': 'HTK', 'LastName': 'Thanh', 'Affiliation': 'Hanoi Medical University, Vietnam National Geriatric Hospital, 1 Ton That Tung Street, Dong Da, Hanoi, Vietnam. hokimthanh@hmu.edu.vn.'}, {'ForeName': 'Tran Manh', 'Initials': 'TM', 'LastName': 'Tien', 'Affiliation': 'Hanoi Medical University, Vietnam National Geriatric Hospital, 1 Ton That Tung Street, Dong Da, Hanoi, Vietnam.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-021-01052-8'] 3665,33839443,Prognostic value of D-dimer levels in patients with gastric cancer undergoing gastrectomy.,"BACKGROUND Plasma D-dimer levels have been associated with tumor progression and oncological outcomes in several cancers. This study assessed the relationships of D-dimer levels with clinicopathological features and survival outcomes in patients with gastric cancer undergoing gastrectomy. METHODS Data from 666 patients with gastric cancer who underwent gastrectomy between June 2012 and December 2015 were collected and analyzed; these data were acquired during a previous randomized clinical trial (PROTECTOR trial, NCT01448746). Optimal cut-off values of preoperative, immediate postoperative, postoperative-day 1, postoperative-day 4, and postoperative-day 30 D-dimer levels for predicting overall survival (OS) and disease-free survival (DFS) were determined using Contal and O'Quigley's method. The optimal cut-off value of the immediate postoperative D-dimer level for predicting OS was 3.33. Patients were divided into D-dimer high and low groups based on these cut-off values. RESULTS High immediate postoperative D-dimer levels were significantly associated with advanced T stage and TNM stage (P = 0.001 and P = 0.006, respectively). OS and DFS were significantly lower for patients in the D-dimer high group than for patients in the D-dimer low group; this relationship was consistent for preoperative, immediate postoperative, postoperative-day 1, and postoperative-day 30 D-dimer levels. Multivariate analysis identified the immediate postoperative D-dimer level as an independent prognostic factor for OS (hazard ratio, 2.52; P = 0.010). CONCLUSIONS Elevated immediate postoperative D-dimer level was predictive of poor long-term outcomes in patients with gastric cancer after gastrectomy. Immediate postoperative D-dimer levels may offer simple and inexpensive clinical decision-making guidance for patients with gastric cancer after gastrectomy.",2021,"OS and DFS were significantly lower for patients in the D-dimer high group than for patients in the D-dimer low group; this relationship was consistent for preoperative, immediate postoperative, postoperative-day 1, and postoperative-day 30 D-dimer levels.","['patients with gastric cancer undergoing gastrectomy', 'patients with gastric cancer after gastrectomy', '666 patients with gastric cancer who underwent gastrectomy between June 2012 and December 2015 were collected and analyzed; these data']",[],"['High immediate postoperative D-dimer levels', 'overall survival (OS) and disease-free survival (DFS', 'Prognostic value of D-dimer levels', 'OS and DFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",666.0,0.139418,"OS and DFS were significantly lower for patients in the D-dimer high group than for patients in the D-dimer low group; this relationship was consistent for preoperative, immediate postoperative, postoperative-day 1, and postoperative-day 30 D-dimer levels.","[{'ForeName': 'Eun Young', 'Initials': 'EY', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, UIjeongbu St. Mary Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea. Electronic address: snuvml@catholic.ac.kr.'}, {'ForeName': 'Kyo Young', 'Initials': 'KY', 'LastName': 'Song', 'Affiliation': 'Department of Surgery, Seoul St. Mary Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea. Electronic address: skygs@catholic.ac.kr.'}]",Surgical oncology,['10.1016/j.suronc.2021.101570'] 3666,33838673,"Effects of supplementation with main coffee components including caffeine and/or chlorogenic acid on hepatic, metabolic, and inflammatory indices in patients with non-alcoholic fatty liver disease and type 2 diabetes: a randomized, double-blind, placebo-controlled, clinical trial.","BACKGROUND Non-alcoholic fatty liver disease (NAFLD) is much more frequent and more severe, including cirrhosis, hepatocellular carcinoma in patients with type 2 diabetes. Coffee is a complex beverage with hundreds of compounds whereas caffeine and chlorogenic acid are the most abundant bioactive compounds. The published epidemiological data demonstrating beneficial associations between all categories of coffee exposure and ranges of liver outcomes are rapidly growing; however, the main contributors and cause-effect relationships have not yet been elucidated. To address existing knowledge gaps, we sought to determine the efficacy and safety of 6 months chlorogenic acid and/or caffeine supplementation in patients with type 2 diabetes affected by NAFLD. METHODS This trial was carried out at two Diabetes Centers to assess the effects of supplementation with daily doses of 200 mg chlorogenic acid, 200 mg caffeine, 200 mg chlorogenic acid plus 200 mg caffeine or placebo (starch) in patients with type 2 diabetes and NAFLD. The primary endpoint was reduction of hepatic fat and stiffness measured by FibroScan, and changes in serum hepatic enzymes and cytokeratin - 18 (CK-18) levels. Secondary endpoints were improvements in metabolic (including fasting glucose, homeostasis model assessment-estimated insulin resistance (HOMA-IR), hemoglobin A1c (HBA1C), C-peptide, insulin and lipid profiles) and inflammatory (including nuclear factor k-B (NF-KB), tumor necrosis factor (TNF-α), high sensitive- C reactive protein(hs-CRP)) parameters from baseline to the end of treatment. RESULTS Neither chlorogenic acid nor caffeine was superior to placebo in attenuation of the hepatic fat and stiffness and other hepatic outcomes in patients with diabetes and NAFLD. Except for the lower level of total cholesterol in caffeine group (p = 0.04), and higher level of insulin in chlorogenic acid plus caffeine group (p = 0.01) compared with placebo, there were no significant differences among the treatment groups. CONCLUSION These findings do not recommend caffeine and/or chlorogenic acid to treat NAFLD in type 2 diabetes patients. TRIAL REGISTRATION IRCT201707024010N21 . Registered 14 September 2017.",2021,Neither chlorogenic acid nor caffeine was superior to placebo in attenuation of the hepatic fat and stiffness and other hepatic outcomes in patients with diabetes and NAFLD.,"['patients with type 2 diabetes and NAFLD', 'type 2 diabetes patients', 'patients with type 2 diabetes affected by NAFLD', 'patients with type 2 diabetes', 'patients with non-alcoholic fatty liver disease and type 2 diabetes', 'patients with diabetes and NAFLD']","['chlorogenic acid and/or caffeine supplementation', '200\u2009mg chlorogenic acid, 200\u2009mg caffeine, 200\u2009mg chlorogenic acid plus 200\u2009mg caffeine or placebo (starch', 'chlorogenic acid nor caffeine', 'supplementation with main coffee components including caffeine and/or chlorogenic acid', 'placebo', 'caffeine and/or chlorogenic acid']","['reduction of hepatic fat and stiffness measured by FibroScan, and changes in serum hepatic enzymes and cytokeratin -\u200918 (CK-18) levels', 'level of total cholesterol', 'hepatic fat and stiffness and other hepatic outcomes', 'efficacy and safety', 'hepatic, metabolic, and inflammatory indices', 'metabolic (including fasting glucose, homeostasis model assessment-estimated insulin resistance (HOMA-IR), hemoglobin A1c (HBA1C), C-peptide, insulin and lipid profiles) and inflammatory (including nuclear factor k-B (NF-KB), tumor necrosis factor (TNF-α), high sensitive- C reactive protein(hs-CRP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0008240', 'cui_str': 'Chlorogenic acid'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0428321', 'cui_str': 'Measurement of liver enzyme'}, {'cui': 'C0010805', 'cui_str': 'Cytokeratin 18'}, {'cui': 'C1455201', 'cui_str': 'KRT18 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0079904', 'cui_str': 'Immunoglobulin Enhancer-Binding Protein'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",,0.5381,Neither chlorogenic acid nor caffeine was superior to placebo in attenuation of the hepatic fat and stiffness and other hepatic outcomes in patients with diabetes and NAFLD.,"[{'ForeName': 'Asieh', 'Initials': 'A', 'LastName': 'Mansour', 'Affiliation': 'Department of Clinical Nutrition & Dietetics, Faculty of Nutrition Sciences and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Mohajeri-Tehrani', 'Affiliation': 'Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Samadi', 'Affiliation': 'Radiology Department, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Qorbani', 'Affiliation': 'Non-communicable Diseases Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Merat', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Adibi', 'Affiliation': 'Diabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Poustchi', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Azita', 'Initials': 'A', 'LastName': 'Hekmatdoost', 'Affiliation': 'Department of Clinical Nutrition & Dietetics, Faculty of Nutrition Sciences and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran. a_hekmat2000@yahoo.com.'}]",Nutrition journal,['10.1186/s12937-021-00694-5'] 3667,33843971,Effectiveness of Targeted Interventions on Treatment of Infants With Bronchiolitis: A Randomized Clinical Trial.,"Importance In developed countries, bronchiolitis is the most common reason for infants to be admitted to the hospital, and all international bronchiolitis guidelines recommend supportive care; however, significant variation in practice continues with infants receiving non-evidence-based therapies. Deimplementation research aims to reduce the use of low-value care, and advancing science in this area is critical to delivering evidence-based care. Objective To determine the effectiveness of targeted interventions vs passive dissemination of an evidence-based bronchiolitis guideline in improving treatment of infants with bronchiolitis. Design, Setting, and Participants This international, multicenter cluster randomized clinical trial included 26 hospitals (clusters) in Australia and New Zealand providing tertiary or secondary pediatric care (13 randomized to intervention, 13 to control) during the 2017 bronchiolitis season. Data were collected on 8003 infants for the 3 bronchiolitis seasons (2014-2016) before the implementation period and 3727 infants for the implementation period (2017 bronchiolitis season, May 1-November 30). Data were analyzed from November 16, 2018, to December 9, 2020. Interventions Interventions were developed using theories of behavior change to target key factors that influence bronchiolitis management. These interventions included site-based clinical leads, stakeholder meetings, a train-the-trainer workshop, targeted educational delivery, other educational and promotional materials, and audit and feedback. Main Outcomes and Measures The primary outcome was compliance during the first 24 hours of care with no use of chest radiography, albuterol, glucocorticoids, antibiotics, and epinephrine, measured retrospectively from medical records of randomly selected infants with bronchiolitis who presented to the hospital. There were no patient-level exclusions. Results A total of 26 hospitals were randomized without dropouts. Analysis was by intention to treat. Baseline data collected on 8003 infants for 3 bronchiolitis seasons (2014-2016) before the implementation period were similar between intervention and control hospitals. Implementation period data were collected on 3727 infants, including 2328 boys (62%) and 1399 girls (38%), with a mean (SD) age of 6.0 (3.2) months. A total of 459 (12%) were Māori (New Zealand), and 295 (8%) were Aboriginal/Torres Strait Islander (Australia). Compliance with recommendations was 85.1% (95% CI, 82.6%-89.7%) in intervention hospitals vs 73.0% (95% CI, 65.3%-78.8%) in control hospitals (adjusted risk difference, 14.1%; 95% CI, 6.5%-21.7%; P < .001). Conclusions and Relevance Targeted interventions led to improved treatment of infants with bronchiolitis. This study has important implications for bronchiolitis management and the development of effective interventions to deimplement low-value care. Trial Registration Australian and New Zealand Clinical Trials Registry: ACTRN12616001567415.",2021,"Compliance with recommendations was 85.1% (95% CI, 82.6%-89.7%) in intervention hospitals vs 73.0% (95% CI, 65.3%-78.8%) in control hospitals (adjusted risk difference, 14.1%; 95% CI, 6.5%-21.7%; P < .001). ","['8003 infants for the 3 bronchiolitis seasons (2014-2016) before the implementation period and 3727 infants for the implementation period (2017 bronchiolitis season, May 1-November 30', 'Trial Registration\n\n\nAustralian and New Zealand', 'A total of 459 (12%) were Māori (New Zealand), and 295 (8%) were Aboriginal/Torres Strait Islander (Australia', 'A total of 26 hospitals', 'infants with bronchiolitis', 'Infants With Bronchiolitis', '26 hospitals (clusters) in Australia and New Zealand providing tertiary or secondary pediatric care (13 randomized to intervention, 13 to control) during the 2017 bronchiolitis season', '8003 infants for 3 bronchiolitis seasons (2014-2016) before the implementation period were similar between intervention and control hospitals', '3727 infants, including 2328 boys (62%) and 1399 girls (38%), with a mean (SD) age of 6.0 (3.2) months']",['Targeted Interventions'],"['compliance during the first 24 hours of care with no use of chest radiography, albuterol, glucocorticoids, antibiotics, and epinephrine']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001311', 'cui_str': 'Acute bronchiolitis'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C3839839', 'cui_str': 'Pediatric care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]",8003.0,0.130632,"Compliance with recommendations was 85.1% (95% CI, 82.6%-89.7%) in intervention hospitals vs 73.0% (95% CI, 65.3%-78.8%) in control hospitals (adjusted risk difference, 14.1%; 95% CI, 6.5%-21.7%; P < .001). ","[{'ForeName': 'Libby', 'Initials': 'L', 'LastName': 'Haskell', 'Affiliation': ""Children's Emergency Department, Starship Children's Hospital, Auckland, New Zealand.""}, {'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Tavender', 'Affiliation': ""Emergency Research, Murdoch Children's Research Institute, Victoria, Australia.""}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Wilson', 'Affiliation': ""Emergency Research, Murdoch Children's Research Institute, Victoria, Australia.""}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': ""O'Brien"", 'Affiliation': ""Emergency Department, Perth Children's Hospital, Western Australia, Australia.""}, {'ForeName': 'Franz E', 'Initials': 'FE', 'LastName': 'Babl', 'Affiliation': ""Emergency Research, Murdoch Children's Research Institute, Victoria, Australia.""}, {'ForeName': 'Meredith L', 'Initials': 'ML', 'LastName': 'Borland', 'Affiliation': ""Emergency Department, Perth Children's Hospital, Western Australia, Australia.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cotterell', 'Affiliation': 'Armidale Rural Referral Hospital, New South Wales, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Schembri', 'Affiliation': ""Clinical Epidemiology and Biostatistics, Melbourne Children's Trials Center, Murdoch Children's Research Institute, Victoria, Australia.""}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Orsini', 'Affiliation': ""Clinical Epidemiology and Biostatistics, Melbourne Children's Trials Center, Murdoch Children's Research Institute, Victoria, Australia.""}, {'ForeName': 'Nicolette', 'Initials': 'N', 'LastName': 'Sheridan', 'Affiliation': 'Center for Nursing and Health Research, Massey University, Auckland, Auckland, New Zealand.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Johnson', 'Affiliation': 'Department of Pediatrics, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Oakley', 'Affiliation': ""Emergency Research, Murdoch Children's Research Institute, Victoria, Australia.""}, {'ForeName': 'Stuart R', 'Initials': 'SR', 'LastName': 'Dalziel', 'Affiliation': ""Children's Emergency Department, Starship Children's Hospital, Auckland, New Zealand.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA pediatrics,['10.1001/jamapediatrics.2021.0295'] 3668,33843663,"Does paravertebral ozone injection have efficacy as an additional treatment for acute lumbar disc herniation? A randomized, double-blind, placebo-controlled study.","OBJECTIVE In this study we investigate the effects of paravertebral ozone injections (POI), which have been used as a new treatment approach for lower back pain in recent years, on pain and physical activity in patients with acute lumbar disc herniation (LDH) as an additional treatment. METHODS Thirty-eight patients were assigned into the ozone therapy (OT) group (n= 20) and placebo control (PC) group (n= 18). Both groups received two sessions per week, a total of 8 sessions of lumbar POI. The ozone concentrations of 20-25 μg/ml (30 ml) and 0.1 μg/ml (30 ml) were administered to the OT and PC groups, respectively. The patients were assessed with the visual analog scale (VAS) and Oswestry Disability Index (ODI) before the treatment (V1), 15 (V2) and 30 (V3) days after the treatment started, and one month (V4) after the treatment ended. RESULTS A significant improvement was seen in the VAS and ODI scores in the final follow-up (V4) as compared with the baselines scores (V1) in both groups (P< 0.05). The patients in the OT group had lower mean VAS and ODI scores in V2, V3, and V4 follow-ups compared with the patients in the PC group. This significant difference reached its peak in the final follow-up (V4) (P< 0.05). CONCLUSION As an additional treatment combined with conservative treatment, lumbar POI can lessen pain and disability in patients with acute LDH.",2021,"This significant difference reached its peak in the final follow-up (V4) (P< 0.05). ","['Thirty-eight patients', 'patients with acute LDH', 'patients with acute lumbar disc herniation (LDH']","['conservative treatment, lumbar POI', 'placebo control (PC', 'ozone therapy (OT', 'paravertebral ozone injections (POI', 'placebo', 'paravertebral ozone injection']","['mean VAS and ODI scores', 'VAS and ODI scores', 'visual analog scale (VAS) and Oswestry Disability Index (ODI', 'pain and disability']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc'}]","[{'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4727847', 'cui_str': 'Ozone therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C2960603', 'cui_str': 'Oswestry disability index score'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",38.0,0.0662807,"This significant difference reached its peak in the final follow-up (V4) (P< 0.05). ","[{'ForeName': 'Hamza', 'Initials': 'H', 'LastName': 'Sucuoğlu', 'Affiliation': 'School of Health Sciences, Istanbul Gelisim University, Istanbul, Turkey.'}, {'ForeName': 'Nalan', 'Initials': 'N', 'LastName': 'Soydaş', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Private Nisa Hospital, Istanbul, Turkey.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-200194'] 3669,33842908,"A randomized, double-blind, placebo-controlled phase 1 trial of inhaled and intranasal niclosamide: A broad spectrum antiviral candidate for treatment of COVID-19.","Background Coronavirus disease 19 (COVID-19) is spreading globally and treatment options remain limited. A formulation of niclosamide, a potent anti-SARS-CoV-2 agent and a broad-spectrum antiviral treatment candidate, optimized for inhalation and intranasal administration (UNI91104) was developed. Methods We conducted a randomized, placebo-controlled, double-blind, single-centre, dose-ascending Phase 1 trial to assess the safety of UNI91104 in Denmark (NCT04576312). Healthy volunteers were randomly assigned to a ascending single dose in cohort 1-4 and five doses over 2.5 days in cohort 5. Inclusion criteria included a minimum 80% of predicted lung function. Exclusion criteria included severe, clinically significant allergies and current acute or chronic condition especially airway diseases. Safety was evaluated through adverse events (AEs) and pulmonary function tests including forced expiratory volume in one second (FEV1) and fractional exhaled nitric oxide (FeNO) tests. The primary endpoints were defined as the frequency of reported AEs and the change of safety variables relative to pre-dose. Data from all enroled healthy volunteers receiving any amount of IMP was included in the primary analyses. The pharmacokinetics of UNI91104 was determined. Findings The trial was conducted between 29 June 2020 and 08 August 2020. Thirty-four healthy volunteers received UNI91104 and ten placebo. No serious AEs or discontinuation were reported. Mild irritation in the upper respiratory tract following inhalation of UNI91104 was reported as most frequent AE (45 events in 26 healthy volunteers, 59% of all healthy volunteers). Nasal application was well-tolerated. There was no evidence of difference in the change of mean levels of pulmonary function tests between active and placebo group across all cohorts. Five healthy volunteers (11.4%) (1 on placebo) had signs of increased transient FeNO and 4 on active (9.1%) experienced asymptomatic drops in FEV1, which resolved spontaneously or were reversible with a β2-agonist. Niclosamide exhibited dose-proportional pharmacokinetics following inhalation and intranasal administration. Interpretation UNI91104, a promising candidate for inhalation and intranasal therapy against COVID-19 and other viral respiratory tract infections is well-tolerated in healthy volunteers and warrants further testing in patient trials. Funding The study was funded by Innovationsfonden Denmark and UNION therapeutics.",2021,There was no evidence of difference in the change of mean levels of pulmonary function tests between active and placebo group across all cohorts.,"['healthy volunteers', '29 June 2020 and 08 August 2020', 'Five healthy volunteers (11.4%) (1 on', '26 healthy volunteers, 59% of all healthy volunteers', 'Healthy volunteers']","['niclosamide', 'Niclosamide', 'placebo', 'inhaled and intranasal niclosamide']","['signs of increased transient FeNO', 'adverse events (AEs) and pulmonary function tests including forced expiratory volume in one second (FEV1) and fractional exhaled nitric oxide (FeNO) tests', 'Mild irritation', 'mean levels of pulmonary function tests']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4517533', 'cui_str': '11.4'}]","[{'cui': 'C0028017', 'cui_str': 'Niclosamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}]","[{'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",34.0,0.244111,There was no evidence of difference in the change of mean levels of pulmonary function tests between active and placebo group across all cohorts.,"[{'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Backer', 'Affiliation': 'Department of Otorhinolaryngology, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Sjöbring', 'Affiliation': 'UNION therapeutics, Tuborg Havnevej 18, 2900 Hellerup, Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Sonne', 'Affiliation': 'Department of Clinical Pharmacology, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Weiss', 'Affiliation': 'Novo Nordisk Center for Biosustainability, Technical University Denmark, Kemitorvet 220, Kongens Lyngby, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Hostrup', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Section of Integrative Physiology, University of Copenhagen, Universitetsparken 13, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Helle Krogh', 'Initials': 'HK', 'LastName': 'Johansen', 'Affiliation': 'Novo Nordisk Center for Biosustainability, Technical University Denmark, Kemitorvet 220, Kongens Lyngby, Denmark.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Becker', 'Affiliation': 'Center for Physical Activity Research, Rigshospitalet, Ole Maaløes vej 24, 2200 Copenhagen, Denmark.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Sonne', 'Affiliation': 'Department of Clinical Pharmacology, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Balchen', 'Affiliation': 'DanTrials, Bispebjerg and Frederiksberg Hospital, Nielsine Nielsens Vej 6B, 2400 Copenhagen NV, Denmark.'}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Jellingsø', 'Affiliation': 'UNION therapeutics, Tuborg Havnevej 18, 2900 Hellerup, Denmark.'}, {'ForeName': 'Morten Otto Alexander', 'Initials': 'MOA', 'LastName': 'Sommer', 'Affiliation': 'UNION therapeutics, Tuborg Havnevej 18, 2900 Hellerup, Denmark.'}]",The Lancet regional health. Europe,['10.1016/j.lanepe.2021.100084'] 3670,33842864,Effectiveness of antenatal screening of asymptomatic bacteriuria in reduction of prematurity and low birth weight: Evaluating a point-of-care rapid test in a pragmatic randomized controlled study.,"Background Premature babies suffer higher mortality and life-long disabilities. Asymptomatic bacteriuria (ASB) is postulated to induce preterm labor. Routine antenatal screening for ASB using urine culture is not feasible in most developing countries due to long turn-around time, user-unfriendliness, and lack of resources. The current parallel-group superiority pragmatic randomized controlled trial evaluated the effect of screening and evidence-based treatment of ASB using an optical-sensor-based point-of-care rapid-test on the incidence of preterm birth and low birthweight (LBW). Methods 240 consenting asymptomatic pregnant women visiting an Indian tertiary public hospital for first antenatal check-up, irrespective of trimester/gravida, who had not consumed antibiotics in the preceding week, were enrolled from February-May 2017. Computer-generated concealed simple randomization allocation sequence was used to assign participants to intervention (120) and control arm (120). Usual hospital-care was provided in the control arm. In the intervention arm, urine samples were additionally screened for ASB using the rapid-test and the positive women were prescribed susceptible antibiotics. Blinded outcome assessors followed up with women post-delivery. The study was registered with the Clinical Trials Registry-India (CTRI/2016/09/007240). Findings 213 participants were analyzed (intervention: 103, control: 110). 21 women were found positive for ASB and prescribed pathogen-specific antibiotics. The incidence of preterm birth/LBW in intervention arm ( n  = 27) was lower than control arm ( n  = 45) by 14·7% (95% CI: 2·2-27·2); RR: 0.64, (95% CI: 0·43-0·95); p  = 0·023, X 2 =5·13. Interpretation Rapid-test-guided treatment for ASB reduced the incidence of preterm birth/LBW in a pragmatic setting without any adverse event. Funding Department of Biotechnology, Government of India.",2021,"The incidence of preterm birth/LBW in intervention arm ( n  = 27) was lower than control arm ( n  = 45) by 14·7% (95% CI: 2·2-27·2); RR: 0.64, (95% CI: 0·43-0·95); p  = 0·023, X 2 =5·13. ","['213 participants were analyzed (intervention: 103, control: 110', '240 consenting asymptomatic pregnant women visiting an Indian tertiary public hospital for first antenatal check-up, irrespective of trimester/gravida, who had not consumed antibiotics in the preceding week, were enrolled from February-May 2017', '21 women']","['screening and evidence-based treatment of ASB using an optical-sensor-based point-of-care rapid-test', 'antenatal screening of asymptomatic bacteriuria']","['mortality and life-long disabilities', 'preterm birth and low birthweight (LBW', 'preterm birth/LBW', 'ASB and prescribed pathogen-specific antibiotics', 'Asymptomatic bacteriuria (ASB', 'incidence of preterm birth/LBW']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0420160', 'cui_str': 'History and physical examination, school'}, {'cui': 'C0032982', 'cui_str': 'Trimesters'}, {'cui': 'C0600457', 'cui_str': 'Gravida'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1740791', 'cui_str': 'Evidence based treatment'}, {'cui': 'C0262380', 'cui_str': 'Asymptomatic bacteriuria'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0260591', 'cui_str': 'Antenatal screening, unspecified'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0262380', 'cui_str': 'Asymptomatic bacteriuria'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",21.0,0.263293,"The incidence of preterm birth/LBW in intervention arm ( n  = 27) was lower than control arm ( n  = 45) by 14·7% (95% CI: 2·2-27·2); RR: 0.64, (95% CI: 0·43-0·95); p  = 0·023, X 2 =5·13. ","[{'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Gehani', 'Affiliation': 'Department of Biological Sciences, Birla Institute of Technology and Science, Pilani, Hyderabad Campus, Hyderabad 500078, India.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Kapur', 'Affiliation': 'Department of Biological Sciences, Birla Institute of Technology and Science, Pilani, Hyderabad Campus, Hyderabad 500078, India.'}, {'ForeName': 'Sudha D', 'Initials': 'SD', 'LastName': 'Madhuri', 'Affiliation': 'Department of Microbiology, Gandhi Medical College and Hospital, Secunderabad 500003, India.'}, {'ForeName': 'Vara Prasad', 'Initials': 'VP', 'LastName': 'Pittala', 'Affiliation': 'Jhpiego, Hyderabad 500038, India.'}, {'ForeName': 'Sree Kala', 'Initials': 'SK', 'LastName': 'Korvi', 'Affiliation': 'Independent Consultant, Hyderabad, 500038, India.'}, {'ForeName': 'Nagamani', 'Initials': 'N', 'LastName': 'Kammili', 'Affiliation': 'Department of Microbiology, Gandhi Medical College and Hospital, Secunderabad 500003, India.'}, {'ForeName': 'Shashwat', 'Initials': 'S', 'LastName': 'Sharad', 'Affiliation': 'Center for Prostate Disease Research, John P. Murtha Cancer Center Research Program, Department of Surgery, Uniformed Services University of the Health Sciences and Walter Reed National Military Medical Center, Bethesda, MD, United States.'}]",EClinicalMedicine,['10.1016/j.eclinm.2021.100762'] 3671,32881054,Acute metabolic responses after continuous or interval exercise in post-menopausal women with overweight or obesity.,"This pilot study compared the effects of acute high-intensity intermittent exercise (HIIE) and moderate-intensity continuous exercise (MICE) on post-exercise VO 2 , fat utilization, and 24-hours energy balance to understand the mechanism of higher fat mass reduction observed after high-intensity interval training in post-menopausal women with overweight/obesity. 12 fasted women (59.5 ± 5.8 years; BMI: 28.9 ± 3.9 kg·m -2 ) completed three isoenergetic cycling exercise sessions in a counterbalanced, randomized order: (a) MICE [35 minutes at 60%-65% of peak heart rate, HR max ], (b) HIIE 1 [60 × (8-s cycling-12-s recovery) at 80%-90% of HR max ], and (c) HIIE 2 [10 × 1min at 80%-90% of HR max  - 1-min recovery]. Then, VO 2 and fat utilization measured at rest and during the 2 hours post-exercise, enjoyment, perceived exertion, and appetite recorded during the session and energy intake (EI) and energy expenditure (EE) assessed over the next 24 hours were compared for the three modalities. Overall, fat utilization increased after exercise. No modality effect or time-modality interaction was observed concerning VO 2 and fat oxidation rate during the 2 hours post-exercise. The two exercise modalities did not induce specific EI and EE adaptations, but perceived appetite scores at 1 hour post-exercise were lower after HIIE 1 and HIIE 2 than MICE. Perceived exertion was higher during HIIE 1 and HIIE 2 than MICE, but enjoyment did not differ among modalities. The acute HIIE responses did not allow explaining the greater fat mass loss observed after regular high-intensity interval training in post-menopausal women with overweight/obesity. More studies are needed to understand the mechanisms involved in such adaptations.",2020,"The two exercise modalities did not induce specific EI and EE adaptations, but perceived appetite scores at 1 hour post-exercise were lower after HIIE 1 and HIIE 2 than MICE.","['post-menopausal women with overweight or obesity', '12 fasted women (59.5\xa0±\xa05.8\xa0years; BMI: 28.9\xa0±\xa03.9\xa0kg·m -2 ) completed three', 'post-menopausal women with overweight/obesity']","['continuous or interval exercise', 'isoenergetic cycling exercise sessions', 'acute high-intensity intermittent exercise (HIIE) and moderate-intensity continuous exercise (MICE', 'high-intensity interval training']","['specific EI and EE adaptations, but perceived appetite scores', 'Acute metabolic responses', 'Overall, fat utilization', 'VO 2 and fat utilization', 'enjoyment, perceived exertion, and appetite recorded during the session and energy intake (EI) and energy expenditure (EE', 'Perceived exertion', 'VO 2 and fat oxidation rate']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}]",12.0,0.0148507,"The two exercise modalities did not induce specific EI and EE adaptations, but perceived appetite scores at 1 hour post-exercise were lower after HIIE 1 and HIIE 2 than MICE.","[{'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Dupuit', 'Affiliation': 'Laboratory of Metabolic Adaptations to Exercise under Physiological and Pathological conditions (AME2P), University Clermont Auvergne (UCA), Clermont-Ferrand, France.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Boscaro', 'Affiliation': 'Laboratory of Metabolic Adaptations to Exercise under Physiological and Pathological conditions (AME2P), University Clermont Auvergne (UCA), Clermont-Ferrand, France.'}, {'ForeName': 'Alban', 'Initials': 'A', 'LastName': 'Bonnet', 'Affiliation': 'Laboratory of Metabolic Adaptations to Exercise under Physiological and Pathological conditions (AME2P), University Clermont Auvergne (UCA), Clermont-Ferrand, France.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Bouillon', 'Affiliation': 'Department of Cardiology, Vichy Hospital, Vichy, France.'}, {'ForeName': 'Pereira', 'Initials': 'P', 'LastName': 'Bruno', 'Affiliation': 'Biostatistics Unit (DRCI), Clermont-Ferrand University Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Morel', 'Affiliation': 'Centre of Resources, Expertise and Performance in Sports (CREPS), Bellerive-sur-Allier, France.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Rance', 'Affiliation': 'Centre of Resources, Expertise and Performance in Sports (CREPS), Bellerive-sur-Allier, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Boisseau', 'Affiliation': 'Laboratory of Metabolic Adaptations to Exercise under Physiological and Pathological conditions (AME2P), University Clermont Auvergne (UCA), Clermont-Ferrand, France.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13814'] 3672,33842329,Case Report: Anlotinib Therapy in a Patient With Recurrent and Metastatic RAIR-DTC Harboring Coexistent TERT Promoter and BRAF V600E Mutations.,"We describe a case of recurrent and metastatic radioactive iodine-refractory differentiated thyroid cancer (RAIR-DTC) treated with anlotinib in this report. The patient was randomized to placebo initially, after disease progressed at C8 (C is the treatment cycle), the patient was referred to the open label therapy of anlotinib, 12 mg p.o. daily with a 2-week on/1-week off regimen. Partial response was achieved at C2 with anlotinib treatment. To date, over 37 months of progression-free survival (PFS) has been achieved. Adverse effects were tolerable and manageable in this patient. Molecular characterization revealed coexistent C228T mutation of TERT promoter and BRAF V600E mutations. Favorable clinical outcome in this patient suggests that anlotinib might provide a novel effective therapeutic option for patients with RAIR-DTC. TERT and BRAF V600E mutations may represent as biomarker for predicting salutary effects of anlotinib.",2021,Adverse effects were tolerable and manageable in this patient.,['patients with RAIR-DTC'],"['metastatic radioactive iodine-refractory differentiated thyroid cancer (RAIR-DTC', 'placebo']",['Partial response'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C4722172', 'cui_str': 'Primary differentiated carcinoma of thyroid gland'}]","[{'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0034553', 'cui_str': 'Radioactivity'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C4722172', 'cui_str': 'Primary differentiated carcinoma of thyroid gland'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1521726', 'cui_str': 'In partial remission'}]",,0.100441,Adverse effects were tolerable and manageable in this patient.,"[{'ForeName': 'Yanjun', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': 'Department of Thyroid Surgery, The First Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Shaohao', 'Initials': 'S', 'LastName': 'Cheng', 'Affiliation': 'Department of Thyroid Surgery, The First Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Qian', 'Affiliation': 'Department of Thyroid Surgery, The First Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Thyroid Surgery, The First Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Tuanli', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Thyroid Surgery, The First Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Thyroid Surgery, The First Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Diao', 'Affiliation': 'Department of Thyroid Surgery, The First Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Thyroid Surgery, The First Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Ruochuan', 'Initials': 'R', 'LastName': 'Cheng', 'Affiliation': 'Department of Thyroid Surgery, The First Affiliated Hospital of Kunming Medical University, Kunming, China.'}]",Frontiers in oncology,['10.3389/fonc.2021.626076'] 3673,33841292,Impact of Teacher's Mental State Talk on Young Children's Theory of Mind: A Quasi-Experiment Study.,"This study investigated the relationship between teachers' mental state talk and young children's theory of mind with a quasi-experiment. In total, 56 young children were assigned to the experiment group (mean age = 41 months, SD = 2.47, 46% girls) and the control group (mean age = 40.68 months, SD = 2.23, 43% girls). The experiment group was engaged in a 12-week intervention program with mental state talk in storytelling, casual conversations, and role-playing games, whereas the control group received no interventions. All the children were tested with three theory of mind (ToM) tasks before and after the intervention. The results indicated that the experimental group had a significant improvement in the ToM scores, whereas the control group showed no significant change. The educational implications of these findings are discussed.",2021,"The results indicated that the experimental group had a significant improvement in the ToM scores, whereas the control group showed no significant change.","['56 young children were assigned to the experiment group (mean age = 41 months, SD = 2.47, 46% girls) and the control group (mean age = 40.68 months, SD = 2.23, 43% girls', ""Young Children's Theory of Mind""]","[""Teacher's Mental State Talk"", 'intervention program with mental state talk in storytelling, casual conversations, and role-playing games, whereas the control group received no interventions']",['ToM scores'],"[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0935573', 'cui_str': 'Theory of Mind'}]","[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0035822', 'cui_str': 'Role play technique'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}]",56.0,0.0272599,"The results indicated that the experimental group had a significant improvement in the ToM scores, whereas the control group showed no significant change.","[{'ForeName': 'Jianfen', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'School of Education, Hangzhou Normal University, Hangzhou, China.'}, {'ForeName': 'Minmin', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Hangzhou Qiantang Jiangchao Kindergarten, Hangzhou, China.'}, {'ForeName': 'Wenqi', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': 'School of Education, Hangzhou Normal University, Hangzhou, China.'}]",Frontiers in psychology,['10.3389/fpsyg.2021.668883'] 3674,33840806,The Effects of Video Instruction on Neuroscience Intensive Care Unit Nursing Skills in Case Presentations and Neurological Examinations.,"ABSTRACT BACKGROUND: The emergence of neuroscience intensive care units (NSICUs) for the past decades has led to growing interest in targeted training for NSICU nurses. We sought to evaluate the use of video instruction on NSICU nurses' skills in case presentations and neurological examinations, which has timely advantages as an asynchronous and distanced learning modality. METHODS: We enrolled NSICU and surgical intensive care unit nurses who took shifts in the NSICU at our institution. Participants were observed by a neurocritical care attending physician presenting the clinical details of an admitted patient and conducting a neurological examination, with both parties completing a 10-item evaluation on NSICU nursing presentation and examination skills. Participants randomized to an intervention group were given access to an instructional video on NSICU nursing skills. A median of 21 days later, participants were observed by a physician blinded to study randomization, with both parties recompleting the evaluation. Differences between day 1 and day 21 scores were analyzed using paired sample t tests. RESULTS: Fifteen NSICU and 55 surgical intensive care unit nurses were enrolled. Surgical intensive care unit nurses in both the intervention and control groups had statistically significant improvement between day 1 and day 21 physician-rated scores, with a greater increase in the intervention group; self-rated scores did not change. For NSICU nurses, there were no differences in physician-rated or self-rated scores for either group. CONCLUSIONS: Surgical intensive care unit nurses who underwent direct observation and self-evaluation had improvement in physician-rated NSICU nursing skills, likely as these activities allowed for reflective observation in Kolb's experiential learning cycle. Greater improvement in participants who viewed an instructional video highlights its value as a teaching modality for nurses.",2021,"Surgical intensive care unit nurses who underwent direct observation and self-evaluation had improvement in physician-rated NSICU nursing skills, likely as these activities allowed for reflective observation in Kolb's experiential learning cycle.","['Fifteen NSICU and 55 surgical intensive care unit nurses were enrolled', 'Surgical intensive care unit nurses who underwent', 'Participants were observed by a neurocritical care attending physician presenting the clinical details of an admitted patient and conducting a neurological examination, with both parties completing a 10-item evaluation on NSICU nursing presentation and examination skills', 'Neuroscience Intensive Care Unit Nursing Skills in Case Presentations and Neurological Examinations', 'surgical intensive care unit nurses who took shifts in the NSICU at our institution']","['direct observation and self-evaluation', 'Video Instruction', 'intervention group were given access to an instructional video on NSICU nursing skills', 'video instruction']",['physician-rated or self-rated scores'],"[{'cui': 'C1690590', 'cui_str': 'Surgical intensive care unit'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1320929', 'cui_str': 'Attending physician'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0189046,"Surgical intensive care unit nurses who underwent direct observation and self-evaluation had improvement in physician-rated NSICU nursing skills, likely as these activities allowed for reflective observation in Kolb's experiential learning cycle.","[{'ForeName': 'K H Vincent', 'Initials': 'KHV', 'LastName': 'Lau', 'Affiliation': 'Questions or comments about this article may be directed to Courtney Takahashi, MD MCR, at courtney.takahashi@bmc.org. C.T. is Assistant Professor, Department of Neurology, Boston University School of Medicine, Boston, MA. K. H. Vincent Lau, MD, is Assistant Professor, Department of Neurology, Boston University School of Medicine, Boston, MA. Emily Hamlyn, NP, is Assistant Professor, Department of Neurology, Boston University School of Medicine, Boston, MA. Thomas James Williams, MD, is Assistant Professor, Department of Neurology, University of Pittsburgh Medical Center, Boston, MA. M. Mustafa Qureshi, MBBS MPH, is Assistant Professor, Department of Radiation Oncology, Boston University School of Medicine, Boston, MA. Kimberley Mak, MD MPH, is Assistant Professor, Department of Radiation Oncology, Boston University School of Medicine, Boston, MA. Asim Mian, MD, is Assistant Professor, Department of Radiology, Boston University School of Medicine, Boston, MA. Anna Cervantes-Arslanian, MD, is Assistant Professor, Department of Neurology, Boston University School of Medicine, Boston, MA. Shuhan Zhu, MD, is Assistant Professor, Department of Neurology, Boston University School of Medicine, Boston, MA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Hamlyn', 'Affiliation': ''}, {'ForeName': 'Thomas James', 'Initials': 'TJ', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'M Mustafa', 'Initials': 'MM', 'LastName': 'Qureshi', 'Affiliation': ''}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Mak', 'Affiliation': ''}, {'ForeName': 'Asim', 'Initials': 'A', 'LastName': 'Mian', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Cervantes-Arslanian', 'Affiliation': ''}, {'ForeName': 'Shuhan', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Takahashi', 'Affiliation': ''}]",The Journal of neuroscience nursing : journal of the American Association of Neuroscience Nurses,['10.1097/JNN.0000000000000591'] 3675,33840805,Early Electroconvulsive Therapy in Patients With Major Depressive Disorder: A Propensity Score-Matched Analysis Using a Nationwide Inpatient Database in Japan.,"OBJECTIVES This study aimed to evaluate whether early electroconvulsive therapy (ECT) can reduce length of hospital stay and total hospitalization costs in major depressive disorder (MDD) patients. METHODS Using the Japanese Diagnosis Procedure Combination inpatient database from April 2011 to March 2018 linked with the Annual Report for Functions of Medical Institutions, we identified patients admitted for MDD. Patients who received ECT within 8 days of admission were assigned to the early ECT group and the remaining patients to the control group. The primary outcomes were length of hospital stay and total hospitalization costs. The secondary outcomes were in-hospital mortality and fatal adverse events. Propensity score-matched analyses were performed to compare the outcomes between the 2 groups. RESULTS We identified 41,248 eligible patients, comprising 1169 in the early ECT group and 40,079 in the control group. After 1:1 propensity score matching, patients in the early ECT group had significantly shorter length of hospital stay than those in the control group (difference: -12.6 days; 95% confidence interval: -17.4 to -7.7 days). There was no significant difference in total hospitalization costs between the 2 groups. Early ECT was not significantly associated with increased in-hospital mortality or fatal adverse events. CONCLUSIONS Early ECT may reduce length of hospital stay without increasing total hospitalization costs or fatal adverse events in patients with MDD.",2021,"Early ECT was not significantly associated with increased in-hospital mortality or fatal adverse events. ","['41,248 eligible patients, comprising 1169 in the early ECT group and 40,079 in the control group', 'Japanese Diagnosis Procedure Combination inpatient database from April 2011 to March 2018 linked with the Annual Report for Functions of Medical Institutions, we identified patients admitted for MDD', 'patients with MDD', 'major depressive disorder (MDD) patients', 'Patients With Major Depressive Disorder']","['ECT', 'early electroconvulsive therapy (ECT', 'Electroconvulsive Therapy']","['hospital mortality or fatal adverse events', 'total hospitalization costs or fatal adverse events', 'length of hospital stay and total hospitalization costs', 'total hospitalization costs', 'shorter length of hospital stay', 'length of hospital stay', 'hospital mortality and fatal adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C1269815', 'cui_str': 'Patient identification'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]",41248.0,0.0404129,"Early ECT was not significantly associated with increased in-hospital mortality or fatal adverse events. ","[{'ForeName': 'Ryuichi', 'Initials': 'R', 'LastName': 'Yamazaki', 'Affiliation': 'From the Department of Psychiatry, The Jikei University School of Medicine Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo Department of Psychiatry, National Center of Neurology and Psychiatry, Tokyo Department of Health Services Research, Faculty of Medicine, University of Tsukuba, Tsukuba Department of Health Policy and Informatics, Tokyo Medical and Dental University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Ohbe', 'Affiliation': ''}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Matsuda', 'Affiliation': ''}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Kito', 'Affiliation': ''}, {'ForeName': 'Kojiro', 'Initials': 'K', 'LastName': 'Morita', 'Affiliation': ''}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Matsui', 'Affiliation': ''}, {'ForeName': 'Kiyohide', 'Initials': 'K', 'LastName': 'Fushimi', 'Affiliation': ''}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Yasunaga', 'Affiliation': ''}]",The journal of ECT,['10.1097/YCT.0000000000000763'] 3676,33840803,"A Randomized, Double-Blind, Sham-Controlled Study of Transcranial Direct Current Stimulation as an Augmentation Intervention for the Attenuation of Motor Deficits in Patients With Stroke.","INTRODUCTION Most studies of transcranial direct current stimulation (tDCS) for motor deficits in patients with stroke administered few sessions of tDCS and with low current amplitude. METHODS During 2015 to 2019, we randomized 60 inpatients with ischemic/hemorrhagic stroke and motor deficits to true or sham tDCS. Transcranial direct current stimulation was administered at 2- to 3-mA current strength, twice daily, 6 days a week, for 2 weeks; anode and cathode were placed over ipsilesional and contralesional motor cortices, respectively. All patients received individualized motor and cognitive rehabilitation. Motor outcomes were assessed 1 day before and 1 day after the tDCS course using the Fugl-Meyer Assessment, the Jebson-Taylor Hand Function Test, and the Barthel index (all coprimary outcomes). Mood and cognition were also assessed. Motor outcomes were compared between groups using age, baseline scores, and latency to treatment as covariates. The study was prospectively registered (CTRI/2017/01/007733). RESULTS The mean age of the patients was 46.9 years. The sample was 73.3% male. Six patients did not complete the study. The covariates were significantly related to motor outcomes. Although all patients showed motor improvements, after adjusting for covariates, tDCS was not superior to sham treatment on any motor, mood, or cognitive outcome. Laterality of hemispheric lesion influenced spatial but not motor outcomes with tDCS. One true tDCS patient developed blistering under the anode and was withdrawn from the study; 3 more reported transient itching during sessions. CONCLUSIONS An intensive course of tDCS, as delivered in this study, does not improve motor, mood, and cognitive outcomes in ischemic/hemorrhagic stroke in patients undergoing individualized rehabilitation. The study provides important leads for directions for future research.",2021,"Although all patients showed motor improvements, after adjusting for covariates, tDCS was not superior to sham treatment on any motor, mood, or cognitive outcome.","['patients with stroke administered few sessions of tDCS and with low current amplitude', 'patients undergoing individualized rehabilitation', '60 inpatients with ischemic/hemorrhagic stroke and motor deficits to true or sham tDCS', 'Patients With Stroke']","['Transcranial Direct Current Stimulation', 'transcranial direct current stimulation (tDCS', 'Transcranial direct current stimulation', 'individualized motor and cognitive rehabilitation']","['Mood and cognition', 'motor, mood, or cognitive outcome', 'Jebson-Taylor Hand Function Test, and the Barthel index', 'Motor outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0205238', 'cui_str': 'True'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}]",60.0,0.169589,"Although all patients showed motor improvements, after adjusting for covariates, tDCS was not superior to sham treatment on any motor, mood, or cognitive outcome.","[{'ForeName': 'Ekta Franscina', 'Initials': 'EF', 'LastName': 'Pinto', 'Affiliation': 'From the Departments of Clinical Psychopharmacology and Neurotoxicology Neurological Rehabilitation Neurology, National Institute of Mental Health and Neurosciences, Bangalore, India.'}, {'ForeName': 'Anupam', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': ''}, {'ForeName': 'Girish Baburao', 'Initials': 'GB', 'LastName': 'Kulkarni', 'Affiliation': ''}, {'ForeName': 'Chittaranjan', 'Initials': 'C', 'LastName': 'Andrade', 'Affiliation': ''}]",The journal of ECT,['10.1097/YCT.0000000000000769'] 3677,33840798,Wheat oral immunotherapy.,"PURPOSE OF REVIEW The prevalence of food allergy is increasing on a global scale, and therefore increased attention is being paid to specific food allergy epidemiology and management. There has been a large amount of progress made in the last decade on human trials of wheat oral immunotherapy (WOIT). RECENT FINDINGS To date, there has been one multicenter, double-blind, randomized controlled trial of WOIT, one randomized, noncontrolled trial of WOIT, and several smaller, nonrandomized clinical trials of WOIT. WOIT trials are generally limited by smaller sample sizes, affecting the demographic skew of evaluated patients. In addition, there is minimal standardization of efficacy and safety outcomes between trial protocols, making head-to-head comparison challenging. However, some common themes emerge. The majority of WOIT regimens result in successful desensitization, and success is more likely with higher maintenance dosing for longer periods of time. Limited studies have looked at sustained unresponsiveness in WOIT. WOIT can induce allergic reactions, including anaphylaxis, but more severe reactions often have an associated augmenting factor, such as exercise. Lower maintenance doses likely are associated with less severe reactions, and food modification and/or adjunct therapeutics may also decrease the risk of reactions. SUMMARY WOIT trials are ongoing and will optimize updosing protocols and maintenance doses to improve efficacy and safety.",2021,"The prevalence of food allergy is increasing on a global scale, and therefore increased attention is being paid to specific food allergy epidemiology and management.",[],[],['efficacy and safety'],[],[],"[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.178585,"The prevalence of food allergy is increasing on a global scale, and therefore increased attention is being paid to specific food allergy epidemiology and management.","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Leeds', 'Affiliation': ""Department of Pediatrics, Yale School of Medicine Department of Medicine, Yale School of Medicine Department of Pediatrics, NYU Grossman School of Medicine, Hassenfeld Childrens' Hospital Department of Pediatrics, Gastroenterology and Nutrition, Collegium Medicum, University of Warmia and Mazury, Olsztyn, Poland.""}, {'ForeName': 'Elise G', 'Initials': 'EG', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Nowak-Wegrzyn', 'Affiliation': ''}]",Current opinion in allergy and clinical immunology,['10.1097/ACI.0000000000000743'] 3678,33840781,"Collagenase Clostridium Histolyticum-aaes for the Treatment of Cellulite in Women: Results From Two Phase 3 Randomized, Placebo-Controlled Trials.","BACKGROUND Fibrous septae play a role in contour alterations associated with cellulite. OBJECTIVE To assess collagenase clostridium histolyticum-aaes (CCH) for the treatment of cellulite. MATERIALS AND METHODS Two identically designed phase 3, double-blind, randomized studies (RELEASE-1 and RELEASE-2) were conducted. Adult women with moderate/severe cellulite (rating 3-4 on the Patient Reported Photonumeric Cellulite Severity Scale [PR-PCSS] and Clinician Reported PCSS [CR-PCSS]) on the buttocks received up to 3 treatment sessions of subcutaneous CCH 0.84 mg or placebo per treatment area. Composite response (≥2-level or ≥1-level improvement from baseline in both PR-PCSS and CR-PCSS) was determined at Day 71. RESULTS Eight hundred forty-three women received ≥1 injection (CCH vs placebo: RELEASE-1, n = 210 vs n = 213; RELEASE-2, n = 214 vs n = 206). Greater percentages of CCH-treated women were ≥2-level composite responders versus placebo in RELEASE-1 (7.6% vs 1.9%; p = .006) and RELEASE-2 (5.6% vs 0.5%; p = .002) and ≥1-level composite responders in RELEASE-1 (37.1% vs 17.8%; p < .001) and RELEASE-2 (41.6% vs 11.2%; p < .001). Most adverse events (AEs) in the CCH group were injection site related; few CCH-treated women discontinued because of an AE (≤4.3%). CONCLUSION Collagenase clostridium histolyticum-aaes significantly improved cellulite appearance and was generally well tolerated.",2021,"Most adverse events (AEs) in the CCH group were injection site related; few CCH-treated women discontinued because of an AE (≤4.3%). ","['Women', 'Adult women with moderate/severe cellulite (rating 3-4 on the Patient Reported', 'n = 210 vs n = 213; RELEASE-2, n = 214 vs n = 206', 'Eight hundred forty-three women received']","['placebo', '≥1 injection (CCH vs placebo', 'Placebo', 'CCH', 'collagenase clostridium histolyticum-aaes (CCH', 'subcutaneous CCH 0.84 mg or placebo']","['Composite response (≥2-level or ≥1-level improvement', 'tolerated', '≥1-level composite responders', 'Photonumeric Cellulite Severity Scale [PR-PCSS']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0424624', 'cui_str': 'Fatty dimpling of skin'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0450368', 'cui_str': '43'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0009053', 'cui_str': 'collagenase Clostridium histolyticum'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0424624', 'cui_str': 'Fatty dimpling of skin'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",843.0,0.283032,"Most adverse events (AEs) in the CCH group were injection site related; few CCH-treated women discontinued because of an AE (≤4.3%). ","[{'ForeName': 'Joely', 'Initials': 'J', 'LastName': 'Kaufman-Janette', 'Affiliation': 'Skin Associates of South Florida, Coral Gables, Florida; John H. Joseph Facial Plastic and Reconstructive Surgery, Beverly Hills, California; Dermatology, SkinCare Physicians, Chestnut Hill, Massachusetts; Charlottesville Medical Research, Charlottesville, Virginia; Cosmetic Laser Dermatology and University of California-San Diego, San Diego, California; Department of Medicine, Division of Dermatology, Tennessee Clinical Research Center, Nashville, Tennessee; Juva Skin & Laser Center, New York, New York; The Education & Research Foundation, Lynchburg, Virginia; Cosmetic Surgery, Skin Specialists P.C., Omaha, Nebraska; Research, Mercy Health Research, Washington, Missouri; Research and Development, Endo Pharmaceuticals Inc, Malvern, Pennsylvania; Medical Affairs, Endo Pharmaceuticals Inc, Malvern, Pennsylvania; Biostatistics, Endo Pharmaceuticals Inc, Malvern, Pennsylvania; and Bass Plastic Surgery PLLC, New York, New York.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Joseph', 'Affiliation': ''}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Kaminer', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Clark', 'Affiliation': ''}, {'ForeName': 'Sabrina G', 'Initials': 'SG', 'LastName': 'Fabi', 'Affiliation': ''}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Gold', 'Affiliation': ''}, {'ForeName': 'Mitchel P', 'Initials': 'MP', 'LastName': 'Goldman', 'Affiliation': ''}, {'ForeName': 'Bruce E', 'Initials': 'BE', 'LastName': 'Katz', 'Affiliation': ''}, {'ForeName': 'Kappa', 'Initials': 'K', 'LastName': 'Peddy', 'Affiliation': ''}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Schlessinger', 'Affiliation': ''}, {'ForeName': 'V Leroy', 'Initials': 'VL', 'LastName': 'Young', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Davis', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hurley', 'Affiliation': ''}, {'ForeName': 'Genzhou', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'McLane', 'Affiliation': ''}, {'ForeName': 'Saji', 'Initials': 'S', 'LastName': 'Vijayan', 'Affiliation': ''}, {'ForeName': 'Lawrence S', 'Initials': 'LS', 'LastName': 'Bass', 'Affiliation': ''}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002952'] 3679,33840773,Varenicline for the Treatment of Cocaine Dependence.,"OBJECTIVES Varenicline is a partial agonist at the α2β4 and α6β2 nAChR receptors and a full agonist at α7 receptors. Both α7 and α6β2 receptors are implicated in the neural reward circuitry activated by cocaine use. A preliminary clinical trial suggested that varenicline treatment reduced cocaine use. This trial was intended to replicate and extend the findings of the previous trial. METHODS This was a 12-week, double-blind, placebo-controlled clinical trial involving 156 subjects with DSM IV cocaine dependence. Subjects received up to 2 mg of varenicline or identical placebo daily along with weekly relapse prevention psychotherapy. The primary outcome measure was cocaine use measured by thrice-weekly urine drug screens. Additional outcome measures included end of study cocaine abstinence, cocaine craving, cocaine withdrawal symptom severity, cigarette use, and global improvement measure by the Clinical Global Improvement Scale. RESULTS End of study cocaine abstinence, measured by urine drug screens during the last 3 weeks of the trial, was not different between groups (8% in the varenicline treated subjects and versus 9% in placebo-treated subjects). Generalized estimating equations analysis of urine drug screen results showed no significant difference between groups in cocaine abstinence over the 12 weeks of the trial. There were no significant differences between the 2 groups in cocaine craving or cocaine withdrawal symptom severity. Varenicline was well-tolerated. There were no medication-associated serious adverse events. CONCLUSIONS Varenicline plus cognitive-behavioral therapy does not seem to be an efficacious treatment for cocaine dependence.",2021,Generalized estimating equations analysis of urine drug screen results showed no significant difference between groups in cocaine abstinence over the 12 weeks of the trial.,"['156 subjects with DSM IV cocaine dependence', 'Cocaine Dependence']","['Varenicline', 'varenicline', 'Varenicline plus cognitive-behavioral therapy', 'placebo', 'varenicline or identical placebo']","['cocaine use measured by thrice-weekly urine drug screens', 'tolerated', 'cocaine craving or cocaine withdrawal symptom severity', 'study cocaine abstinence, cocaine craving, cocaine withdrawal symptom severity, cigarette use, and global improvement measure by the Clinical Global Improvement Scale', 'cocaine abstinence', 'urine drug screens']","[{'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0600427', 'cui_str': 'Cocaine dependence'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205280', 'cui_str': 'Identical'}]","[{'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0009178', 'cui_str': 'Cocaine withdrawal'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",156.0,0.22936,Generalized estimating equations analysis of urine drug screen results showed no significant difference between groups in cocaine abstinence over the 12 weeks of the trial.,"[{'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Lynch', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA (KGL, JP, MM, MT, PF, KMK); Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA (KS).'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Plebani', 'Affiliation': ''}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Spratt', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Morales', 'Affiliation': ''}, {'ForeName': 'Mila', 'Initials': 'M', 'LastName': 'Tamminga', 'Affiliation': ''}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Feibush', 'Affiliation': ''}, {'ForeName': 'Kyle M', 'Initials': 'KM', 'LastName': 'Kampman', 'Affiliation': ''}]",Journal of addiction medicine,['10.1097/ADM.0000000000000842'] 3680,33840769,Machine-Based Hand Massage Ameliorates Preoperative Anxiety in Patients Awaiting Ambulatory Surgery.,"BACKGROUND Hand massage therapies have been used to relieve anxiety and pain in various clinical situations. The effects of machine-based hand massage on preoperative anxiety in ambulatory surgery settings have not been evaluated. The hypothesis examined in this study is that machine-based hand massage is as effective as physical massage in ambulatory surgery patients awaiting surgical procedures. PURPOSE This prospective study was designed to investigate the effect of machine-based hand massage on preoperative anxiety and vital signs in ambulatory surgery patients. METHODS One hundred ninety-nine patients aged 18 years and older who were scheduled to receive ambulatory surgery were recruited from the Taipei Municipal Wanfang Hospital in Taipei City, Taiwan. The patients were assigned randomly to the experimental group (n = 101), which received presurgical machine-based hand massage therapy, and the control group (n = 98), which received no intervention. The patients in both groups completed the Spielberger State-Trait Anxiety Inventory short form at preintervention (baseline) and postintervention. RESULTS Within-group comparisons of Spielberger State-Trait Anxiety Inventory short form scores showed significant decreases between preintervention and postintervention scores in the experimental group (44.3 ± 11.2 to 37.9 ± 8.7) and no significant change in the control group. Within-group comparisons of vital signs revealed a significant increase in mean respiration rate between baseline and postintervention in both groups (both ps < .05). Blood pressure was found to have decreased significantly only in the control group at postintervention (p < .05). No significant preintervention to postintervention change in pulse was observed in either group. CONCLUSIONS The findings of this study indicate that machine-based hand massage reduces anxiety significantly in patients awaiting ambulatory surgery while not significantly affecting their vital signs.",2021,Within-group comparisons of vital signs revealed a significant increase in mean respiration rate between baseline and postintervention in both groups (both ps < .05).,"['patients awaiting ambulatory surgery', 'ambulatory surgery patients', 'Patients Awaiting Ambulatory Surgery', 'One hundred ninety-nine patients aged 18 years and older who were scheduled to receive ambulatory surgery were recruited from the Taipei Municipal Wanfang Hospital in Taipei City, Taiwan', 'ambulatory surgery settings', 'ambulatory surgery patients awaiting surgical procedures']","['presurgical machine-based hand massage therapy', 'Machine-Based Hand Massage', 'machine-based hand massage']","['mean respiration rate', 'Spielberger State-Trait Anxiety Inventory', 'preoperative anxiety and vital signs', 'anxiety', 'Spielberger State-Trait Anxiety Inventory short', 'Blood pressure', 'preintervention and postintervention scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002428', 'cui_str': 'Ambulatory surgery'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3828813', 'cui_str': '99'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C3536731', 'cui_str': 'Massage physiotherapy'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0451497', 'cui_str': 'Spielberger state-trait anxiety inventory'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",199.0,0.0151682,Within-group comparisons of vital signs revealed a significant increase in mean respiration rate between baseline and postintervention in both groups (both ps < .05).,"[{'ForeName': 'Cheng-Hua', 'Initials': 'CH', 'LastName': 'Ni', 'Affiliation': 'MS, RN, Supervisor, Department of Nursing, Center for Nursing and Healthcare Research in Clinical Practice Application, Wan Fang Hospital, Taipei Medical University, and Adjunct Assistant Professor, School of Nursing, College of Nursing, Taipei Medical University, Taiwan, ROC MD, PhD, Assistant Professor, Graduate Institute of Injury Prevention and Control, College of Public Health, Taipei Medical University, and Attending Physician, Division of Neurosurgery, Department of Surgery, Wan Fang Hospital, Taipei Medical University, Taiwan, ROC MD, PhD, Assistant Professor, School of Medicine, College of Medicine, Taipei Medical University, and Attending Physician, Department of Otolaryngology, Wan Fang Hospital, Taipei Medical University, Taiwan, ROC PhD, PT, Associate Professor, Master Program in Long-Term Care, College of Nursing, Taipei Medical University, Taiwan, ROC MS, RN, Head Nurse, Department of Nursing, and Center for Nursing and Healthcare Research in Clinical Practice Application, Wan Fang Hospital, Taipei Medical University, and Adjunct Instructor, School of Nursing, College of Nursing, Taipei Medical University, Taiwan, ROC PhD, RN, Professor, School of Nursing, College of Nursing, Taipei Medical University, and Center for Nursing and Healthcare Research in Clinical Practice Application, Wan Fang Hospital, Taipei Medical University, Taiwan, ROC MS, RN, Executive Director of Community Medicine, Center for Nursing and Healthcare Research in Clinical Practice Application, Wan Fang Hospital, Taipei Medical University, and Adjunct Assistant Professor, School of Nursing, College of Nursing, Taipei Medical University, Taiwan, ROC Contributed equally as corresponding author.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': ''}, {'ForeName': 'Chia-Che', 'Initials': 'CC', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Chueh-Ho', 'Initials': 'CH', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Pao-Yu', 'Initials': 'PY', 'LastName': 'Chou', 'Affiliation': ''}, {'ForeName': 'Yeu-Hui', 'Initials': 'YH', 'LastName': 'Chuang', 'Affiliation': ''}, {'ForeName': 'Ching-Chiu', 'Initials': 'CC', 'LastName': 'Kao', 'Affiliation': ''}]",The journal of nursing research : JNR,['10.1097/jnr.0000000000000432'] 3681,33840751,"Self-reported socket comfort, mobility, and balance-confidence of individuals with transtibial amputation using pinlock vs suction suspension.","BACKGROUND Improper suspension between the residual limb and prosthesis can result in pistoning, which may compromise skin integrity and reduce overall user comfort. In addition to objective measures of limb pistoning, user perspective may provide insight into suspension system effectiveness. OBJECTIVES The primary objective of this analysis was to explore differences in self-reported measures among adults with transtibial amputation (TTA) using pinlock vs suction suspension systems. STUDY DESIGN This is a secondary analysis of cross-sectional data. METHODS Participants (n = 48) were included if they (1) were ≥18 years of age, (2) were community-dwelling, (3) had a unilateral TTA of ≥6 months, and (4) were prescribed a prosthesis with either pinlock or suction suspension. Participants completed self-reported measures evaluating socket comfort (Socket Comfort Score [SCS]), prosthesis-enabled mobility (Prosthesis Evaluation Questionnaire-Mobility Section [PEQ-MS]; Locomotor Capabilities Index [LCI]), and balance-confidence (Activities-Specific Balance Confidence Scale [ABC]). RESULTS Participants using suction suspension reported significantly higher SCS as compared with participants using pinlock suspension (P ≤ .001). No differences were observed between groups for PEQ-MS, LCI, and/or ABC. CONCLUSIONS Individuals with TTA using suction suspension may report greater socket comfort than peers using pinlock suspension, but prosthesis-enabled mobility and balance-confidence may be similar. Future research is warranted to confirm these preliminary findings using a prospective, crossover study design that controls for all suspected factors that might influence socket comfort.",2021,"RESULTS Participants using suction suspension reported significantly higher SCS as compared with participants using pinlock suspension (P ≤ .001).","['Participants (n = 48) were included if they (1) were ≥18 years of age, (2) were community-dwelling, (3) had a unilateral TTA of ≥6 months, and (4) were prescribed a prosthesis with either', 'adults with transtibial amputation (TTA) using pinlock vs suction suspension systems']","['pinlock vs suction suspension', 'TTA using suction suspension', 'pinlock or suction suspension']","['Self-reported socket comfort, mobility, and balance-confidence', ' Locomotor Capabilities Index [LCI]), and balance-confidence (Activities-Specific Balance Confidence Scale [ABC', 'socket comfort (Socket Comfort Score [SCS]), prosthesis-enabled mobility (Prosthesis Evaluation Questionnaire-Mobility Section [PEQ-MS', 'SCS', 'socket comfort', 'PEQ-MS, LCI, and/or ABC']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2733457', 'cui_str': 'Activities specific balance confidence scale'}, {'cui': 'C0152244', 'cui_str': 'Aneurysmal bone cyst'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175699', 'cui_str': 'Saethre-Chotzen syndrome'}, {'cui': 'C0231990', 'cui_str': 'Lung clearance index'}]",48.0,0.0521885,"RESULTS Participants using suction suspension reported significantly higher SCS as compared with participants using pinlock suspension (P ≤ .001).","[{'ForeName': 'Mayank', 'Initials': 'M', 'LastName': 'Seth', 'Affiliation': 'Department of Physical Therapy, University of Delaware, Newark, DE Independence Prosthetics-Orthotics, Inc., Newark, DE Christiana Spine Center, Newark, DE.'}, {'ForeName': 'Emma Haldane', 'Initials': 'EH', 'LastName': 'Beisheim', 'Affiliation': ''}, {'ForeName': 'Maximilian Tobias', 'Initials': 'MT', 'LastName': 'Spencer', 'Affiliation': ''}, {'ForeName': 'John Robert', 'Initials': 'JR', 'LastName': 'Horne', 'Affiliation': ''}, {'ForeName': 'Frank Bernard', 'Initials': 'FB', 'LastName': 'Sarlo', 'Affiliation': ''}, {'ForeName': 'Jaclyn Megan', 'Initials': 'JM', 'LastName': 'Sions', 'Affiliation': ''}]",Prosthetics and orthotics international,['10.1097/PXR.0000000000000007'] 3682,33840750,Immediate effect of prefabricated and UCBL foot orthoses on alignment of midfoot and forefoot in young people with symptomatic flexible flatfoot: A radiographic evaluation.,"BACKGROUND Radiographic imaging has been considered the gold standard in evaluating the skeletal alignment of the foot in static weightbearing. The effects of foot orthoses on the alignment of foot bones have been mostly evaluated using lateral view x-rays. The posterior-anterior view has not been investigated extensively. OBJECTIVES To investigate the effects of 2 foot orthoses: University of California Biomechanics Laboratory Orthosis (UCBL) and a prefabricated orthosis (P-FFO) on the alignment of foot bones on anterior-posterior x-rays in young people with symptomatic flexible flatfoot (SFF). STUDY DESIGN This is a randomized, crossover study. METHODS Fifteen participants (mean [SD], 23.67 ± 2 years) with SFF were randomly imaged in 3 different conditions: shoes only, shoes + P-FFO, and shoes + UCBL. The talonavicular coverage, the first and the second talometatarsal angles, the intermetatarsal angle, and the cuboid abduction angle (CAA) were measured on weightbearing, anterior-posterior x-ray images for each condition. RESULTS Both orthotic designs demonstrated a significant reduction in the talonavicular coverage, the first and the second talometatarsal angles, and the CAA compared with the shoe-only condition (P < .001). The talonavicular coverage angle reduced by ∼11% using P-FFO compared with UCBL (P < .005). No significant differences were observed for other angles between the 2 orthotic conditions. CONCLUSIONS Both orthotic conditions improved the talonavicular coverage, first and the second talometatarsal angle, and CAA in young people with SFF. The walls of the UCBL orthosis did not result in further correction of the talonavicular coverage angle compared with the prefabricated FFO design.",2021,"Both orthotic designs demonstrated a significant reduction in the talonavicular coverage, the first and the second talometatarsal angles, and the CAA compared with the shoe-only condition (P < .001).","['young people with symptomatic flexible flatfoot (SFF', 'young people with symptomatic flexible flatfoot', 'young people with SFF', 'Fifteen participants (mean [SD], 23.67 ± 2 years) with SFF were randomly imaged in 3 different conditions']","['shoes only, shoes + P-FFO, and shoes + UCBL', 'California Biomechanics Laboratory Orthosis (UCBL) and a prefabricated orthosis (P-FFO', 'foot orthoses', 'prefabricated and UCBL foot orthoses']","['talonavicular coverage', 'talonavicular coverage angle']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0152237', 'cui_str': 'Flexible Flatfoot'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0036988', 'cui_str': 'Shoes'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}]","[{'cui': 'C0205143', 'cui_str': 'Angular'}]",15.0,0.0351085,"Both orthotic designs demonstrated a significant reduction in the talonavicular coverage, the first and the second talometatarsal angles, and the CAA compared with the shoe-only condition (P < .001).","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mahdiyar', 'Affiliation': 'Department of Orthotics and Prosthetics, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran Rehabilitation Research Center, Iran University of Medical Sciences, Tehran, Iran Department of Basic Sciences, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran Faculty of Rehabilitation Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Saeedi', 'Affiliation': ''}, {'ForeName': 'Behnoosh', 'Initials': 'B', 'LastName': 'Vasaghi-Gharamaleki', 'Affiliation': ''}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Abdollah', 'Affiliation': ''}]",Prosthetics and orthotics international,['10.1097/PXR.0000000000000010'] 3683,33840631,Changes in fruit and vegetable consumption in relation to changes in sleep characteristics over a 3-month period among young adults.,"OBJECTIVE To evaluate whether increases in fruit and vegetable (FV) consumption were associated with concomitant changes in insomnia symptoms, sleep duration, and quality. DESIGN Secondary longitudinal analysis of a randomized trial, baseline to 3 months. SETTING Integrated health care systems in Detroit, Michigan and Danville, Pennsylvania. PARTICIPANTS About 1165 young adults who were low consumers of FV (<3 servings/day) at baseline. INTERVENTION Online 3-arm program designed to increase FV consumption. MEASUREMENTS We categorized FV changes into 4 categories: no change or decrease, 1 serving increase, 2 serving increase, and 3 or more serving increase. We then compared the changes in chronic insomnia classification (yes or no), sleep duration, quality, and time to fall asleep (all self-reported) across the FV change categories. Analyses were both overall and stratified by gender, adjusting for potential confounders (depression, physical activity, education, children, and study site). RESULTS Average age ± SD was 26 ± 2.8 years (71% women). At 3-month follow-up, participants on average increased FV intake by 1.2 ± 1.4 servings. Women who increased FV intake by 3+ servings showed improvements in insomnia symptoms (2-fold higher odds of improvement; 95% CI 1.1 to 3.6), sleep quality (0.2-point higher sleep quality score; 95% CI -0.01, 0.3), and time to fall asleep (4.2 minutes; 95% CI -8, 0) compared to women who did not change or decreased their FV intake. Associations were not as apparent among men. CONCLUSION Young women with low consumption of FV may experience improvements in insomnia-related sleep difficulties by increasing their consumption of FV.",2021,"Women who increased FV intake by 3+ servings showed improvements in insomnia symptoms (2-fold higher odds of improvement; 95% CI 1.1 to 3.6), sleep quality (0.2-point higher sleep quality score; 95% CI -0.01, 0.3), and time to fall asleep (4.2 minutes; 95% CI -8, 0) compared to women who did not change or decreased their FV intake.","['Young women with low consumption of FV', 'About 1165 young adults who were low consumers of FV (<3 servings/day) at baseline', 'Integrated health care systems in Detroit, Michigan and Danville, Pennsylvania', 'young adults']",[],"['categorized FV changes into 4 categories: no change or decrease, 1 serving increase, 2 serving increase, and 3 or more serving increase', 'insomnia symptoms, sleep duration, and quality', 'fruit and vegetable (FV) consumption', 'sleep quality', 'chronic insomnia classification (yes or no), sleep duration, quality, and time to fall asleep', 'time to fall asleep', 'FV intake', 'insomnia symptoms']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0282599', 'cui_str': 'Integrated Health Care Systems'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}]",[],"[{'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0442739', 'cui_str': 'No status change'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C1298908', 'cui_str': 'No'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0424522', 'cui_str': 'Asleep'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}]",1165.0,0.0865249,"Women who increased FV intake by 3+ servings showed improvements in insomnia symptoms (2-fold higher odds of improvement; 95% CI 1.1 to 3.6), sleep quality (0.2-point higher sleep quality score; 95% CI -0.01, 0.3), and time to fall asleep (4.2 minutes; 95% CI -8, 0) compared to women who did not change or decreased their FV intake.","[{'ForeName': 'Erica C', 'Initials': 'EC', 'LastName': 'Jansen', 'Affiliation': 'Department of Nutritional Sciences, University of Michigan School of Public Health, Ann Arbor, Michigan, USA; Division of Sleep Medicine, Department of Neurology, University of Michigan Medicine, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Ruicong', 'Initials': 'R', 'LastName': 'She', 'Affiliation': 'Henry Ford Health System, Detroit, Michigan, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Rukstalis', 'Affiliation': 'Department of Neuropsychiatry and Behavioral Science, University of South Carolina School of Medicine -Prisma - Midlands, Columbia, South Carolina.'}, {'ForeName': 'Gwen L', 'Initials': 'GL', 'LastName': 'Alexander', 'Affiliation': 'Henry Ford Health System, Detroit, Michigan, USA. Electronic address: GALEXAN2@hfhs.org.'}]",Sleep health,['10.1016/j.sleh.2021.02.005'] 3684,33840608,Once daily tacrolimus conversion in lung transplantation: A prospective study on safety and medication adherence.,"BACKGROUND Lung transplantation (LTx) requires a calcineurin inhibitor-based immunosuppressive regimen. A once daily (QD) tacrolimus regimen was developed to increase medication adherence. However, data concerning its safety and efficacy in LTx are lacking. METHODS In this prospective study, stable LTx patients were consecutively converted from twice daily (BID) tacrolimus to QD tacrolimus on a 1 mg:1 mg basis. Trough level (C min ), renal function, cholesterol, fasting glucose, potassium and lung function were monitored six months before and up to one year after conversion. Adherence and its barriers were assessed by self-reported questionnaires (Basel Assessment of Adherence to Immunosuppressive Medications Scale (BAASIS) and Identification of Medication Adherence Barriers questionnaire (IMAB)) and blood-based assays (mean C min and coefficient of variation (CV)). RESULTS We included 372 patients, in whom we observed a decrease in tacrolimus C min of 18.5% (p < 0.0001) post-conversion, requiring subsequent daily dose adaptations in both cystic fibrosis (CF) (n = 72) and non-CF patients (n = 300). We observed a small decrease in eGFR one year post-conversion (p = 0.024). No significant changes in blood creatinine, potassium, fasting glucose, cholesterol or rate of lung function decline were observed. In a subgroup of 166 patients, significantly fewer patients missed doses (8.4% vs. 19.3%, p = 0.016) or had irregular intake post-conversion (19.3% vs. 32.5%, p = 0.019). Mean C min and CV, as well as the total number of barriers, also decreased significantly post-conversion. CONCLUSIONS In LTx, conversion from BID to QD tacrolimus (1 mg:1 mg) requires close monitoring of tacrolimus C min . QD tacrolimus after transplantation is safe with respect to renal function, metabolic parameters and allograft function and improves LTx recipient adherence.",2021,"QD tacrolimus after transplantation is safe with respect to renal function, metabolic parameters and allograft function and improves LTx recipient adherence.","['stable LTx patients', 'lung transplantation', 'min of 18.5% (p < 0.0001) post-conversion, requiring subsequent daily dose adaptations in both cystic fibrosis (CF) (n\u202f=\u202f72) and non-CF patients (n\u202f=\u202f300', '372 patients']","['QD tacrolimus', 'tacrolimus to QD tacrolimus']","['Trough level (C min ), renal function, cholesterol, fasting glucose, potassium and lung function', 'tacrolimus C', 'self-reported questionnaires (Basel Assessment of Adherence to Immunosuppressive Medications Scale (BAASIS) and Identification of Medication Adherence Barriers questionnaire (IMAB)) and blood-based assays (mean C min and coefficient of variation (CV', 'irregular intake post-conversion', 'renal function, metabolic parameters and allograft function and improves LTx recipient adherence', 'Mean C min and CV', 'total number of barriers', 'medication adherence', 'blood creatinine, potassium, fasting glucose, cholesterol or rate of lung function decline']","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024128', 'cui_str': 'Transplant of lung'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4517611', 'cui_str': '18.5'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}]","[{'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0205271', 'cui_str': 'Irregular'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0201975', 'cui_str': 'Creatinine measurement'}]",372.0,0.0160719,"QD tacrolimus after transplantation is safe with respect to renal function, metabolic parameters and allograft function and improves LTx recipient adherence.","[{'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Godinas', 'Affiliation': 'Department of Respiratory Diseases, Lung Transplantation Group, UZ Leuven, Campus Gasthuisberg, Leuven, Belgium; Laboratory of Respiratory Diseases and Thoracic Surgery (BREATHE), Department CHROMETA, KU Leuven, Leuven, Belgium. Electronic address: Laurent.Godinas@uzleuven.be.'}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Dobbels', 'Affiliation': 'Academic Center for Nursing and Midwifery, Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Leni', 'Initials': 'L', 'LastName': 'Hulst', 'Affiliation': 'Department of Respiratory Diseases, Lung Transplantation Group, UZ Leuven, Campus Gasthuisberg, Leuven, Belgium.'}, {'ForeName': 'Ive', 'Initials': 'I', 'LastName': 'Verbeeck', 'Affiliation': 'Academic Center for Nursing and Midwifery, Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'De Coninck', 'Affiliation': 'Academic Center for Nursing and Midwifery, Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Berrevoets', 'Affiliation': 'Academic Center for Nursing and Midwifery, Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Schaevers', 'Affiliation': 'Department of Respiratory Diseases, Lung Transplantation Group, UZ Leuven, Campus Gasthuisberg, Leuven, Belgium.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Yserbyt', 'Affiliation': 'Department of Respiratory Diseases, Lung Transplantation Group, UZ Leuven, Campus Gasthuisberg, Leuven, Belgium; Laboratory of Respiratory Diseases and Thoracic Surgery (BREATHE), Department CHROMETA, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Lieven J', 'Initials': 'LJ', 'LastName': 'Dupont', 'Affiliation': 'Department of Respiratory Diseases, Lung Transplantation Group, UZ Leuven, Campus Gasthuisberg, Leuven, Belgium; Laboratory of Respiratory Diseases and Thoracic Surgery (BREATHE), Department CHROMETA, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Stijn E', 'Initials': 'SE', 'LastName': 'Verleden', 'Affiliation': 'Laboratory of Respiratory Diseases and Thoracic Surgery (BREATHE), Department CHROMETA, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Bart M', 'Initials': 'BM', 'LastName': 'Vanaudenaerde', 'Affiliation': 'Laboratory of Respiratory Diseases and Thoracic Surgery (BREATHE), Department CHROMETA, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Laurens J', 'Initials': 'LJ', 'LastName': 'Ceulemans', 'Affiliation': 'Laboratory of Respiratory Diseases and Thoracic Surgery (BREATHE), Department CHROMETA, KU Leuven, Leuven, Belgium; Department of Thoracic Surgery, Lung transplantation group, UZ Leuven, Campus Gasthuisberg, Leuven, Belgium.'}, {'ForeName': 'Dirk E', 'Initials': 'DE', 'LastName': 'Van Raemdonck', 'Affiliation': 'Laboratory of Respiratory Diseases and Thoracic Surgery (BREATHE), Department CHROMETA, KU Leuven, Leuven, Belgium; Department of Thoracic Surgery, Lung transplantation group, UZ Leuven, Campus Gasthuisberg, Leuven, Belgium.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Neyrinck', 'Affiliation': 'Laboratory of Respiratory Diseases and Thoracic Surgery (BREATHE), Department CHROMETA, KU Leuven, Leuven, Belgium; Department of Anesthesiology, Lung transplantation group, UZ Leuven, Campus Gasthuisberg, Leuven, Belgium.'}, {'ForeName': 'Geert M', 'Initials': 'GM', 'LastName': 'Verleden', 'Affiliation': 'Department of Respiratory Diseases, Lung Transplantation Group, UZ Leuven, Campus Gasthuisberg, Leuven, Belgium; Laboratory of Respiratory Diseases and Thoracic Surgery (BREATHE), Department CHROMETA, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Vos', 'Affiliation': 'Department of Respiratory Diseases, Lung Transplantation Group, UZ Leuven, Campus Gasthuisberg, Leuven, Belgium; Laboratory of Respiratory Diseases and Thoracic Surgery (BREATHE), Department CHROMETA, KU Leuven, Leuven, Belgium.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2021.02.017'] 3685,33840592,"Effects of different electrical stimulation currents and phase durations on submaximal and maximum torque, efficiency, and discomfort: a randomized crossover trial.","BACKGROUND Neuromuscular electrical stimulation (NMES) is an important therapeutic tool for rehabilitation. However, best stimulation parameters remain to be determined. OBJECTIVE To determine the influence of different electrical stimulation currents and phase durations on torque, efficiency, and discomfort. METHODS Using a cross-over design, kHz frequency alternating currents (KFAC) and pulsed currents (PC) with narrow (200 µs) or wide (500 µs) phase durations were randomly applied on knee extensor muscles of healthy participants with a minimum of seven days between sessions. The NMES-evoked torque, NMES-efficiency, and discomfort (visual 0-10 cm analogue scale) were measured for each stimulation intensity increments (10 mA). Statistics were conducted using a three-way analysis of variances (phase duration x current x intensity), followed by Tukey post-hoc. RESULTS Twenty-four males (age 22.3 ± 3.5years) were included. No effect of NMES current was observed for torque, efficiency, and discomfort. For wide phase durations (500 µs), torque significantly increased for all stimulation intensities. For narrow phase durations (200 µs) evoked torque significantly increased only after 40% of maximal stimulation intensity. Phase durations of 500 µs produced greater torque than 200 µs. Discomfort was greater with 500 µs when compared to 200 µs. Submaximal relative torque, for example 40% of maximum voluntary contraction (MVC), was obtained with ∼ 60% and ∼ 80% of the maximal current intensity for 500 µs and 200 µs, respectively. CONCLUSION KFAC and PC current applied with the same phase duration induced similar relative submaximal and maximum evoked-torque, efficiency, and perceived discomfort. However, currents with 500 µs induced higher evoked-torque, current efficiency, and perceived discomfort.",2021,"No effect of NMES current was observed for torque, efficiency, and discomfort.",['Twenty-four males (age 22.3\u202f±\u202f3.5years) were included'],"['Neuromuscular electrical stimulation (NMES', 'kHz frequency alternating currents (KFAC) and pulsed currents (PC) with narrow (200\u202fµs) or wide (500\u202fµs) phase durations were randomly applied', 'NMES', 'electrical stimulation currents']","['evoked torque', 'evoked-torque, current efficiency, and perceived discomfort', 'submaximal and maximum torque, efficiency, and discomfort', 'torque, efficiency, and discomfort', 'Discomfort', 'NMES-evoked torque, NMES-efficiency, and discomfort (visual 0-10\u202fcm analogue scale', 'relative submaximal and maximum evoked-torque, efficiency, and perceived discomfort']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0556965', 'cui_str': 'kHz'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0442830', 'cui_str': 'Alternating current'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1632850', 'cui_str': 'Apply'}]","[{'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",,0.0208698,"No effect of NMES current was observed for torque, efficiency, and discomfort.","[{'ForeName': 'Natália Lucília', 'Initials': 'NL', 'LastName': 'Pinto Damo', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade de Brasília, Brasília, DF, Brazil.'}, {'ForeName': 'Karenina Arrais', 'Initials': 'KA', 'LastName': 'Modesto', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade de Brasília, Brasília, DF, Brazil.'}, {'ForeName': 'Ivo Vieira de Sousa', 'Initials': 'IVS', 'LastName': 'Neto', 'Affiliation': 'Graduate Program of Sciences and Technology of Health, Universidade de Brasília, Brasília, DF, Brazil.'}, {'ForeName': 'Martim', 'Initials': 'M', 'LastName': 'Bottaro', 'Affiliation': 'College of Physical Education Department, Universidade de Brasília, Brasília, DF, Brazil.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Babault', 'Affiliation': 'INSERM U1093 CAPS, Faculty of Sport Sciences, University of Burgundy, Dijon, France.'}, {'ForeName': 'João Luiz Quaglioti', 'Initials': 'JLQ', 'LastName': 'Durigan', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade de Brasília, Brasília, DF, Brazil. Electronic address: joaodurigan@gmail.com.'}]",Brazilian journal of physical therapy,['10.1016/j.bjpt.2021.03.001'] 3686,33840575,Damage of the ocular surface from indoor suntanning-Insights from in vivo confocal microscopy.,"PURPOSE To evaluate the ocular surface at the microstructural level of adults who habitually undertake indoor-suntanning utilising in vivo confocal microscopy. METHODS Participants were prospectively recruited and enrolled into either а study group (n = 75) with a history UV indoor tanning, or a control group (n = 75) with no prior history of artificial tanning. The study group participated in voluntary tanning sessions performed with standard equipment and maintained their usual routine for eye protection. Slit lamp biomicroscopy and in vivo confocal microscopy were performed at baseline before undertaking a series of suntanning sessions (10 sessions of 10 min duration over a 15 day period), within three days after the last session, and four weeks after the last session. Control group participants were examined at baseline and 8 weeks later and did not participate in tanning sessions. RESULTS All participants were female with a mean age of 25 ± 4 years and 24 ± 4 years in the study and control groups, respectively. No clinically significant changes were observed in either group over time using slit lamp biomicroscopy (all p ≥ 0.05), however, statistically significant differences were observed between the study and the control group for all corneal layers imaged using confocal microscopy (all p ≤ 0.03). Characteristic cystic conjunctival lesions with dark centres and bright borders were observed in 95% of the study group before and in 100% after the suntanning sessions. CONCLUSION Indoor suntanning resulted in statistically significant microstructural changes in the cornea and the bulbar conjunctiva that are undetectable with slit lamp biomicroscopy.",2021,"No clinically significant changes were observed in either group over time using slit lamp biomicroscopy (all p ≥ 0.05), however, statistically significant differences were observed between the study and the control group for all corneal layers imaged using confocal microscopy (all p ≤ 0.03).","['All participants were female with a mean age of 25 ± 4 years and 24 ± 4 years in the study and control groups, respectively', 'Participants were prospectively recruited and enrolled into either а study group (n = 75) with a history UV indoor tanning, or a control group (n = 75) with no prior history of artificial tanning', 'adults who habitually undertake indoor-suntanning utilising in vivo confocal microscopy']","['Slit lamp biomicroscopy', 'voluntary tanning sessions performed with standard equipment and maintained their usual routine for eye protection']","['Characteristic cystic conjunctival lesions with dark centres and bright borders', 'time using slit lamp biomicroscopy']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0039295', 'cui_str': 'Tanning'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0242842', 'cui_str': 'Confocal Microscopy'}]","[{'cui': 'C0419360', 'cui_str': 'Ocular slit lamp examination'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0039295', 'cui_str': 'Tanning'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0521125', 'cui_str': 'For'}]","[{'cui': 'C0205207', 'cui_str': 'Cystic'}, {'cui': 'C1393738', 'cui_str': 'Lesion of conjunctiva'}, {'cui': 'C0332582', 'cui_str': 'Dark color'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0423899', 'cui_str': 'Above average intellect'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0419360', 'cui_str': 'Ocular slit lamp examination'}]",75.0,0.0639651,"No clinically significant changes were observed in either group over time using slit lamp biomicroscopy (all p ≥ 0.05), however, statistically significant differences were observed between the study and the control group for all corneal layers imaged using confocal microscopy (all p ≤ 0.03).","[{'ForeName': 'Christina N', 'Initials': 'CN', 'LastName': 'Grupcheva', 'Affiliation': 'Department of Ophthalmology and Visual Science, Medical University, Varna, Bulgaria. Electronic address: cgrupcheva@gmail.com.'}, {'ForeName': 'Mladena N', 'Initials': 'MN', 'LastName': 'Radeva', 'Affiliation': 'Department of Ophthalmology and Visual Science, Medical University, Varna, Bulgaria.'}, {'ForeName': 'Dimitar I', 'Initials': 'DI', 'LastName': 'Grupchev', 'Affiliation': 'Department of Ophthalmology and Visual Science, Medical University, Varna, Bulgaria.'}, {'ForeName': 'Silviya P', 'Initials': 'SP', 'LastName': 'Nikolova', 'Affiliation': 'Department of Social Medicine and Healthcare Organization, Medical University, Varna, Bulgaria.'}]",Contact lens & anterior eye : the journal of the British Contact Lens Association,['10.1016/j.clae.2021.03.005'] 3687,33840570,"Piezoelectric tools versus traditional oscillating saw for distal linear osteotomy in hallux valgus correction: Triple-blinded, randomized controlled study.","BACKGROUND The main goal of the surgical correction of the hallux valgus is the morphological correction associated with the functional rebalancing of the first ray. The aim of this triple-blinded, randomized controlled study was to show the efficacy of piezosurgery in performing distal linear osteotomy of the first metatarsal bone in HV correction, in terms of clinical and radiological outcomes at 1-year final follow up. METHODS AND MATERIALS This study was performed collecting prospectively pre-operative and post-operative data for all patients. 34 patients were included in the trial and were randomly allocated (1:1) in a Piezoelectric Group (PG) that involved the use of piezoelectric tools and in a Control Group (CG) that provided for the use of a traditional oscillating saw. In both groups, all patients were treated with a distal linear osteotomy of the first metatarsal bone. Clinical and radiographic assessments were performed. RESULTS The AOFAS score between the two groups was similar pre-operatively and during the follow-up period, with a slight superiority in the PG at each evaluation. The osteotomy surgical time was registered for both groups. Among the endpoints of the study, the radiological bone healing time was independently assessed by a radiologist that reported a lower mean value in the piezoelectric group compared with the control group. CONCLUSIONS This trial has shown that piezoelectric surgery is not inferior to traditional methods from the clinical-functional point of view, but can even lead to an evident reduction of bone healing time with a statistical significance. LEVEL OF EVIDENCE Level I.",2021,"The AOFAS score between the two groups was similar pre-operatively and during the follow-up period, with a slight superiority in the PG at each evaluation.",['34 patients were included in the trial'],"['Piezoelectric tools versus traditional oscillating saw for distal linear osteotomy', 'hallux', 'Piezoelectric Group (PG) that involved the use of piezoelectric tools and in a Control Group (CG']","['osteotomy surgical time', 'AOFAS score', 'radiological bone healing time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0018534', 'cui_str': 'Hallux structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1321023', 'cui_str': 'Bone healing status'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",34.0,0.0706736,"The AOFAS score between the two groups was similar pre-operatively and during the follow-up period, with a slight superiority in the PG at each evaluation.","[{'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Mosca', 'Affiliation': 'II Clinic of Orthopaedics and Traumatology, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy. Electronic address: massimiliano.mosca@ior.it.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Russo', 'Affiliation': 'II Clinic of Orthopaedics and Traumatology, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy. Electronic address: alessandro.russo@ior.it.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Caravelli', 'Affiliation': 'II Clinic of Orthopaedics and Traumatology, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy. Electronic address: doct.car@gmail.com.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Massimi', 'Affiliation': 'II Clinic of Orthopaedics and Traumatology, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy. Electronic address: dottmassimi@gmail.com.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Vocale', 'Affiliation': 'II Clinic of Orthopaedics and Traumatology, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy. Electronic address: emanuelevocale@gmail.com.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Grassi', 'Affiliation': 'II Clinic of Orthopaedics and Traumatology, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy. Electronic address: alberto.grassi@ior.it.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Censoni', 'Affiliation': 'II Clinic of Orthopaedics and Traumatology, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy. Electronic address: censonidavide@hotmail.it.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Fuiano', 'Affiliation': 'II Clinic of Orthopaedics and Traumatology, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy. Electronic address: mariofuiano@yahoo.it.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Zaffagnini', 'Affiliation': 'II Clinic of Orthopaedics and Traumatology, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy. Electronic address: stefano.zaffagnini@unibo.it.'}]",Foot and ankle surgery : official journal of the European Society of Foot and Ankle Surgeons,['10.1016/j.fas.2021.03.024'] 3688,33840514,Radiographic evaluation of a bone substitute material in alveolar ridge preservation for maxillary removable immediate dentures: A randomized controlled trial.,"STATEMENT OF PROBLEM Maxillary bone resorption after multiple extractions can jeopardize the success of an immediate denture, but whether bone volume preservation techniques are effective is unclear. PURPOSE The purpose of this randomized controlled trial was to evaluate the efficacy of socket grafting with a xenogenic bone substitute in participants receiving maxillary immediate removable complete dentures in terms of bone volume preservation (height and width of the bone ridge). MATERIAL AND METHODS The study was a single-blinded, randomized controlled clinical trial with 2 balanced parallel arms. Thirty-six participants who had Kennedy Class I edentulous posterior areas bilaterally for at least 3 months and required maxillary immediate removable complete dentures were enrolled. Duplicates of the removable complete denture were made and converted into radiographic and surgical guides. Participants allocated to the test group received deproteinized bovine bone mineral blended with 10% porcine collagen (DBBM-C) in the extraction sockets, and participants in the control group received no grafting material. With a radiographic guide in place, cone beam computed tomography scans were made 10 days after tooth extraction, when the immediate removable complete denture was delivered (D10, baseline), after 3 months (D90), and after 1 year (D365). The scans were superimposed, and measurements were made on the cross-sectional plane of each extraction site. The influence of various prognosis factors associated with bone volume preservation, including the location of tooth extraction, smoking habits, periodontal disease, and operator team, were analyzed. RESULTS Of 36 participants, 3 were lost to follow-up. The mean ±standard deviation loss of height of the buccal crest was 1.2 ±1.8 mm in the control group and 0.3 ±1.2 mm in the test group after 3 months of healing (P<.001) and 2.1 ±2.0 mm in the control group and 0.7 ±1.4 mm in the test group after 1 year of follow-up (P<.001). Mean ±standard deviation horizontal ridge width change was 1.3 ±1.4 mm in the control group and 0.5 ±0.8 mm in the test group after 3 months (P<.001) and 2.2 ±1.4 mm in the control group and 0.9 ±1.1 mm in the test group after 1 year of follow-up (P<.001). None of the other prognostic factors had a significant effect at either time period. CONCLUSIONS Grafting DBBM-C into the extraction socket after removing anterior teeth for immediate removable denture therapy resulted in significantly less vertical buccal crest and horizontal ridge resorption as compared with spontaneous socket healing after 1 year of follow-up. This procedure may be useful for preserving bone, especially when a fixed implant-supported prosthesis is planned.",2021,Mean ±standard deviation horizontal ridge width change was 1.3 ±1.4 mm in the control group and 0.5 ±0.8 mm in the test group after 3 months (P<.001) and 2.2 ±1.4 mm in the control group and 0.9 ±1.1 mm in the test group after 1 year of follow-up (P<.001).,"['36 participants', 'maxillary removable immediate dentures', 'Thirty-six participants who had Kennedy Class I edentulous posterior areas bilaterally for at least 3 months and required maxillary immediate removable complete dentures were enrolled', 'participants receiving maxillary immediate removable complete dentures in terms of bone volume preservation (height and width of the bone ridge']","['socket grafting with a xenogenic bone substitute', 'deproteinized bovine bone mineral blended with 10% porcine collagen (DBBM-C', 'control group received no grafting material']","['vertical buccal crest and horizontal ridge resorption', 'location of tooth extraction, smoking habits, periodontal disease, and operator team', 'Mean ±standard deviation horizontal ridge width change', 'mean ±standard deviation loss of height of the buccal crest']","[{'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0457284', 'cui_str': 'Immediate denture'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0011455', 'cui_str': 'Complete denture'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}]","[{'cui': 'C2354284', 'cui_str': 'socket graft'}, {'cui': 'C0243003', 'cui_str': 'Bone Substitute'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C3486131', 'cui_str': 'Pork collagen preparation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0206138', 'cui_str': 'CREST syndrome'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C4505437', 'cui_str': 'Smoking Habit'}, {'cui': 'C0031090', 'cui_str': 'Periodontal disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0424641', 'cui_str': 'Decrease in height'}]",36.0,0.0866226,Mean ±standard deviation horizontal ridge width change was 1.3 ±1.4 mm in the control group and 0.5 ±0.8 mm in the test group after 3 months (P<.001) and 2.2 ±1.4 mm in the control group and 0.9 ±1.1 mm in the test group after 1 year of follow-up (P<.001).,"[{'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Rignon-Bret', 'Affiliation': 'Associate Professor, Prosthodontics Department, Université de Paris, Hôpital Charles Foix, Ivry-sur-Seine, France. Electronic address: rignon-bret@wanadoo.fr.'}, {'ForeName': 'Claudine', 'Initials': 'C', 'LastName': 'Wulfman', 'Affiliation': 'Professor, Prosthodontics Department, Université de Paris, Hôpital Henri Mondor, Créteil, France.'}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Valet', 'Affiliation': 'Biostatistician, Statistics Department, DenomX, Eaubonne, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Hadida', 'Affiliation': 'Associate Professor, Surgery Department, Université de Paris - AP-HP, Hôpital Henri Mondor, Créteil, France.'}, {'ForeName': 'Thien-Huong', 'Initials': 'TH', 'LastName': 'Nguyen', 'Affiliation': 'Hospital Practitioner, Dentistry Department, Université de Paris - AP-HP, Hôpital Henri Mondor, Créteil, France.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Aidan', 'Affiliation': 'Assistant Professor, Prosthodontics Department, Université de Paris - AP-HP, Hôpital Henri Mondor, Créteil, France.'}, {'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Naveau', 'Affiliation': 'Associate Professor, Prosthodontics Department, Université de Bordeaux - Bordeaux University Hospital, Bordeaux, France.'}]",The Journal of prosthetic dentistry,['10.1016/j.prosdent.2021.02.013'] 3689,33840497,Early effect of simultaneous intravitreal dexamethasone and bevacizumab combination treatment in patients with persistent diabetic macular edema.,"PURPOSE To report the early effect of simultaneous intravitreal dexamethasone and bevacizumab combination treatment in patients with persistent diabetic macular edema (DME). METHODS In this single-center prospective non-randomized study, 65 eyes of 59 patients with persistent DME were included. In the combined group (Group 1), we treated 35 eyes of 29 persistent DME patients with a simultaneous combination of intravitreal dexamethasone and bevacizumab, and in the control group (Group 2), we treated 30 eyes of 30 patients with intravitreal bevacizumab. Changes in Best Corrected Visual Acuity (BCVA), Central Macular Thickness (CMT) and Intraocular Pressure (IOP) from the initial visit to each subsequent follow-up visit (1st, 2nd and 3rd months) were recorded. RESULTS In Group 1, the mean baseline Early Treatment Diabetic Retinopathy (ETDRS) BCVA letter score was 44.1±19.3 (range 20-51), improving significantly to 58.8±18.2 (range 42-73) in the first month (P<0.05), 57±19.2 (range 40-72) in the second month (P<0.05) and 55.4±18.4 (range 34-71) in the third month (P<0.05). In Group 2, the mean pre-injection BCVA ETDRS letter score was 43.3±18.8 (range 20-56) and did not improve significantly; the letter score was 44.3±18.1 (range 20-49) in the third month. In Group 1, the mean BCVA change from baseline to the 3rd month was 11.3 ETDRS letters. In Group 2, the mean BCVA change from baseline to the 3rd month was 1 ETDRS letter. In Group 1, the mean reduction in CMT from baseline was -142.25μm. In Group 2, the mean reduction in CMT from baseline was -17.30μm. In Group 1 at the third month, 12 (34.2%) eyes with a CMT>300μm needed an additional injection. No serious ocular or systemic side effects occurred in any patient. CONCLUSION Simultaneous intravitreal dexamethasone and bevacizumab combination treatment is effective and can be used safely in persistent DME.",2021,"BCVA letter score was 44.1±19.3 (range 20-51), improving significantly to 58.8±18.2 (range 42-73) in the first month (P<0.05), 57±19.2 (range 40-72) in the second month (P<0.05) and 55.4±18.4 (range 34-71) in the third month (P<0.05).","['patients with persistent diabetic macular edema', '65 eyes of 59 patients with persistent DME were included', 'patients with persistent diabetic macular edema (DME']","['dexamethasone and bevacizumab combination', 'intravitreal bevacizumab', 'intravitreal dexamethasone and bevacizumab', 'simultaneous intravitreal dexamethasone and bevacizumab combination treatment']","['mean pre-injection BCVA ETDRS letter score', 'BCVA letter score', 'serious ocular or systemic side effects', 'Best Corrected Visual Acuity (BCVA), Central Macular Thickness (CMT) and Intraocular Pressure (IOP', 'mean BCVA change', 'mean baseline Early Treatment Diabetic Retinopathy (ETDRS', 'mean reduction in CMT', 'letter score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",59.0,0.0856198,"BCVA letter score was 44.1±19.3 (range 20-51), improving significantly to 58.8±18.2 (range 42-73) in the first month (P<0.05), 57±19.2 (range 40-72) in the second month (P<0.05) and 55.4±18.4 (range 34-71) in the third month (P<0.05).","[{'ForeName': 'U', 'Initials': 'U', 'LastName': 'Limon', 'Affiliation': 'Health Sciences University Umraniye Training and Research Hospital Eye Clinic Istanbul, Elmalıkent Mahallesi Adem Yavuz Cad. No:1 Ümraniye, 34000 Istanbul, Turkey. Electronic address: utku_limon@hotmail.com.'}]",Journal francais d'ophtalmologie,['10.1016/j.jfo.2020.08.033'] 3690,33840474,Oxygen delivery-guided perfusion for the prevention of acute kidney injury: A randomized controlled trial.,"OBJECTIVES The reduction of postoperative acute kidney injury in patients undergoing cardiopulmonary bypass surgery using an oxygen delivery-guided perfusion strategy (oxygen delivery strategy) for cardiopulmonary bypass management compared with a fixed flow perfusion (conventional strategy) remains controversial. The purpose of this study was to determine whether a oxygen delivery strategy would reduce the incidence of postoperative acute kidney injury in patients undergoing cardiopulmonary bypass surgery. METHODS We randomly enrolled 300 patients undergoing cardiopulmonary bypass surgery. Patients were randomly assigned to a oxygen delivery strategy (maintaining a oxygen delivery index value >300 mL/min/m 2 through pump flow adjustments during cardiopulmonary bypass) or a conventional strategy (a target pump flow was determined on the basis of the body surface area). The primary end point was the development of acute kidney injury. Secondary end points were the red blood cell transfusion rate and number of red blood cell units, intubation time, postoperative length of stay in the intensive care unit and the hospital, predischarge estimated glomerular filtration rate, and hospital mortality. RESULTS Acute kidney injury occurred in 20 patients (14.6%) receiving the oxygen delivery strategy and in 42 patients (30.4%) receiving the conventional strategy (relative risk, 0.48; 95% confidence interval, 0.30-0.77; P = .002). The secondary end points were not significantly different between strategies. In a prespecified subgroup analysis of patients who had nadir hematocrit less than 23% or body surface area less than 1.40 m 2 , the oxygen delivery strategy seemed to be superior to the conventional strategy and the existence of quantitative interactions was suggested. CONCLUSIONS An oxygen delivery strategy for cardiopulmonary bypass management was superior to a conventional strategy with respect to preventing the development of acute kidney injury.",2021,An oxygen delivery strategy for cardiopulmonary bypass management was superior to a conventional strategy with respect to preventing the development of acute kidney injury.,"['patients undergoing cardiopulmonary bypass surgery using an', 'patients undergoing cardiopulmonary bypass surgery', 'acute kidney injury', '300 patients undergoing']","['cardiopulmonary bypass management compared with a fixed flow perfusion (conventional strategy', 'Oxygen delivery-guided perfusion', 'cardiopulmonary bypass surgery', 'oxygen delivery-guided perfusion strategy (oxygen delivery strategy', 'oxygen delivery strategy (maintaining a oxygen delivery index value >300\xa0mL/min/m 2 through pump flow adjustments during cardiopulmonary bypass) or a conventional strategy']","['Acute kidney injury', 'development of acute kidney injury', 'red blood cell transfusion rate and number of red blood cell units, intubation time, postoperative length of stay in the intensive care unit and the hospital, predischarge estimated glomerular filtration rate, and hospital mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0429622', 'cui_str': 'Oxygen delivery'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}]","[{'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0086252', 'cui_str': 'Transfusion of red blood cells'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}]",300.0,0.139914,An oxygen delivery strategy for cardiopulmonary bypass management was superior to a conventional strategy with respect to preventing the development of acute kidney injury.,"[{'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Mukaida', 'Affiliation': 'Department of Clinical Engineering, Juntendo University Hospital, Tokyo, Japan; Department of Cardiovascular Surgery, Juntendo University, Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Matsushita', 'Affiliation': 'Department of Cardiovascular Surgery, Juntendo University, Faculty of Medicine, Tokyo, Japan. Electronic address: saty-m@juntendo.ac.jp.'}, {'ForeName': 'Taira', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Cardiovascular Surgery, Juntendo University, Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Minami', 'Affiliation': 'Department of Clinical Engineering, Juntendo University Hospital, Tokyo, Japan.'}, {'ForeName': 'Go', 'Initials': 'G', 'LastName': 'Sato', 'Affiliation': 'Department of Clinical Engineering, Juntendo University Hospital, Tokyo, Japan.'}, {'ForeName': 'Tohru', 'Initials': 'T', 'LastName': 'Asai', 'Affiliation': 'Department of Cardiovascular Surgery, Juntendo University, Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Amano', 'Affiliation': 'Department of Cardiovascular Surgery, Juntendo University, Faculty of Medicine, Tokyo, Japan.'}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2021.03.032'] 3691,33840470,Lung metastasectomy for colorectal cancer: The impression of benefit from uncontrolled studies was not supported in a randomized controlled trial.,,2021,,['colorectal cancer'],[],[],"[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]",[],[],,0.412022,,"[{'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Treasure', 'Affiliation': 'Clinical Operational Research Unit, University College London, London, United Kingdom. Electronic address: tom.treasure@gmail.com.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Dunning', 'Affiliation': 'James Cook University Hospital, Middlesbrough, United Kingdom.'}, {'ForeName': 'Norman R', 'Initials': 'NR', 'LastName': 'Williams', 'Affiliation': 'Surgical and Interventional Trials Unit, University College London, London, United Kingdom.'}, {'ForeName': 'Fergus', 'Initials': 'F', 'LastName': 'Macbeth', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, United Kingdom.'}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2021.01.142'] 3692,33840429,Late Pregnancy Ultrasound to Screen for and Manage Potential Birth Complications in Nulliparous Women: A Cost-Effectiveness and Value of Information Analysis.,"BACKGROUND Fetal growth restriction is a major risk factor for stillbirth. A routine late-pregnancy ultrasound scan could help detect this, allowing intervention to reduce the risk of stillbirth. Such a scan could also detect fetal presentation and predict macrosomia. A trial powered to detect stillbirth differences would be extremely large and expensive. OBJECTIVES It is therefore critical to know whether this would be a good investment of public research funds. The aim of this study is to estimate the cost-effectiveness of various late-pregnancy screening and management strategies based on current information and predict the return on investment from further research. METHODS Synthesis of current evidence structured into a decision model reporting expected costs, quality-adjusted life-years, and net benefit over 20 years and value-of-information analysis reporting predicted return on investment from future clinical trials. RESULTS Given a willingness to pay of £20 000 per quality-adjusted life-year gained, the most cost-effective strategy is a routine presentation-only scan for all women. Universal ultrasound screening for fetal size is unlikely to be cost-effective. Research exploring the cost implications of induction of labor has the greatest predicted return on investment. A randomized, controlled trial with an endpoint of stillbirth is extremely unlikely to be a value for money investment. CONCLUSION Given current value-for-money thresholds in the United Kingdom, the most cost-effective strategy is to offer all pregnant women a presentation-only scan in late pregnancy. A randomized, controlled trial of screening and intervention to reduce the risk of stillbirth following universal ultrasound to detect macrosomia or fetal growth restriction is unlikely to represent a value for money investment.",2021,"A randomized, controlled trial of screening and intervention to reduce the risk of stillbirth following universal ultrasound to detect macrosomia or fetal growth restriction is unlikely to represent a value for money investment.","['pregnant women a presentation-only scan in late pregnancy', 'Nulliparous Women']","['screening and intervention', 'Universal ultrasound screening']",[],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]",[],,0.0656015,"A randomized, controlled trial of screening and intervention to reduce the risk of stillbirth following universal ultrasound to detect macrosomia or fetal growth restriction is unlikely to represent a value for money investment.","[{'ForeName': 'Edward C F', 'Initials': 'ECF', 'LastName': 'Wilson', 'Affiliation': 'Health Economics Group, Norwich Medical School, University of East Anglia, Norwich, UK; The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK. Electronic address: ed.wilson@uea.ac.uk.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wastlund', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK; Parexel Access Consulting, Parexel International, Stockholm, Sweden.'}, {'ForeName': 'Alexandros A', 'Initials': 'AA', 'LastName': 'Moraitis', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Cambridge, NIHR Cambridge Biomedical Research Centre, Cambridge, UK.'}, {'ForeName': 'Gordon C S', 'Initials': 'GCS', 'LastName': 'Smith', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Cambridge, NIHR Cambridge Biomedical Research Centre, Cambridge, UK.'}]",Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research,['10.1016/j.jval.2020.11.005'] 3693,33840367,Effects of full windshield head-up display on visual attention allocation.,"This study explores the impact of full windshield head-up display (FHUD) cues on the visual attention allocation of drivers under different scenarios. Forty-eight participants with driving experience were randomly divided into two groups and asked to drive on a preset route in various virtual driving scenarios created in advance. The full windshield highlights situational cues related to the driving task, such as lane lines, safe vehicle distance warnings, navigation guidance and pedestrian cues. Regarding the perception of situational cues, the number of fixations and mean fixation duration with FHUD were lower than those without FHUD. Furthermore, the dwell time percentage of the driver's forward view with FHUD was larger than that without FHUD, and the dwell time percentage on both sides was smaller than that without FHUD. In conclusion, FHUD may help drivers more effectively perceive cues and improve drivers' visual attention allocation. Practitioner Summary: FHUD may affect drivers' attention while driving. We examined the effect of FHUD on number of fixations, fixation duration and dwell time percentage in the area of interest under different weather scenarios. Experimental results indicated that FHUD could improve drivers' visual attention allocation and help drivers more effectively perceive cues.",2021,"Regarding the perception of situational cues, the number of fixations and mean fixation duration with FHUD were lower than those without FHUD.","['Forty-eight participants with driving experience', 'drivers under different scenarios']","['FHUD', 'full windshield head-up display (FHUD) cues']","['visual attention allocation', 'number of fixations, fixation duration and dwell time percentage', ""drivers' visual attention allocation"", 'perception of situational cues, the number of fixations and mean fixation duration with FHUD', ""dwell time percentage of the driver's forward view with FHUD""]","[{'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}]","[{'cui': 'C5200727', 'cui_str': 'Head Up Display'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]","[{'cui': 'C0589102', 'cui_str': 'Visual attention'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0429659', 'cui_str': 'Dwell time'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C5200727', 'cui_str': 'Head Up Display'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0449911', 'cui_str': 'View'}]",48.0,0.0622649,"Regarding the perception of situational cues, the number of fixations and mean fixation duration with FHUD were lower than those without FHUD.","[{'ForeName': 'Yanjun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'College of Mechanical Engineering, Yangzhou University, Yangzhou, 225127, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': 'College of Mechanical Engineering, Yangzhou University, Yangzhou, 225127, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'College of Civil Aviation, Nanjing University of Aeronautics and Astronautics, Nanjing 210016, China.'}, {'ForeName': 'Yongjin', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'School of Mathematics and Physics, Anhui University of Technology, Maanshan 243002, China.'}, {'ForeName': 'Youchao', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'College of Civil Aviation, Nanjing University of Aeronautics and Astronautics, Nanjing 210016, China.'}]",Ergonomics,['10.1080/00140139.2021.1912398'] 3694,33840359,PLYOMETRIC EXERCISE ENHANCES TWITCH CONTRACTILE PROPERTIES BUT FAILS TO IMPROVE VOLUNTARY RATE OF TORQUE DEVELOPMENT IN HIGHLY-TRAINED SPRINT ATHLETES.,"PURPOSE The objective of this study was to evaluate a plyometric conditioning activity (3 sets of 5 countermovement jumps, [CA]) for twitch properties and voluntary knee extension. METHODS After a familiarization session, fourteen highly-trained sprint athletes, 12 men (23.25 ± 7.17 years) and 2 women (23.0 ± 2.8 years) performed 2 experiments, each in a randomized order (crossover design). In one experiment, the time-course of twitch contractile properties was evaluated with and without the previous CA at 2, min intervals to 10 min of recovery. In the second session, maximal voluntary knee extension was evaluated at the same recovery intervals, for control and experimental condition in random order. RESULTS Mixed-model ANOVA with Bonferroni post-hoc revealed significant differences between pretest and 2 min (p<0.01, ES=0.42) and 4 min (p<0.01, ES=0.20) for peak twitch torque of quadriceps femoris muscles confirming postactivation potentiation [PAP] at these times. Twitch rate of torque development (RTD) was significantly greater than pretest value only at 2 min (p < 0.01, ES=0.58) after the CA. Twitch contraction time and ½ relaxation time were not significantly difference from pretest values after the CA (p>0.05). No significant difference was observed for voluntary RTD following CA. CONCLUSION The plyometric CA increased twitch peak torque and RTD consistent with PAP; however, there was no effect of CA on voluntary RTD of knee extension at any time after the plyometric CA. Even with PAP confirmed, we observed that the CA fails to improve isometric RTD of quadriceps femoris muscles.",2021,Twitch contraction time and ½ relaxation time were not significantly difference from pretest values after the CA (p>0.05).,"['fourteen highly-trained sprint athletes, 12 men (23.25 ± 7.17 years) and 2 women (23.0 ± 2.8 years']","['CA', 'plyometric conditioning activity (3 sets of 5 countermovement jumps, [CA']","['peak twitch torque of quadriceps femoris muscles confirming postactivation potentiation [PAP', 'Twitch contraction time and ½ relaxation time', 'isometric RTD of quadriceps femoris muscles', 'maximal voluntary knee extension', 'Twitch rate of torque development (RTD', 'voluntary RTD of knee extension', 'voluntary RTD', 'time-course of twitch contractile properties', 'twitch peak torque and RTD']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0086188', 'cui_str': 'Drug Potentiation'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0449247', 'cui_str': 'Time course'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0871161', 'cui_str': 'Property'}]",14.0,0.0511308,Twitch contraction time and ½ relaxation time were not significantly difference from pretest values after the CA (p>0.05).,"[{'ForeName': 'Haiko Bruno', 'Initials': 'HB', 'LastName': 'Zimmermann', 'Affiliation': 'Biomechanics Laboratory, Center of Sports, Federal University of Santa Catarina, Florianopolis - Brazil.'}, {'ForeName': 'Filipe Estácio', 'Initials': 'FE', 'LastName': 'Costa', 'Affiliation': 'Biomechanics Laboratory, Center of Sports, Federal University of Santa Catarina, Florianopolis - Brazil.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Sakugawa', 'Affiliation': 'Biomechanics Laboratory, Center of Sports, Federal University of Santa Catarina, Florianopolis - Brazil.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'MacIntosh', 'Affiliation': 'Human Performance Laboratory, Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Diefenthaeler', 'Affiliation': 'Biomechanics Laboratory, Center of Sports, Federal University of Santa Catarina, Florianopolis - Brazil.'}, {'ForeName': 'Juliano Dal', 'Initials': 'JD', 'LastName': 'Pupo', 'Affiliation': 'Biomechanics Laboratory, Center of Sports, Federal University of Santa Catarina, Florianopolis - Brazil.'}]",European journal of sport science,['10.1080/17461391.2021.1916083'] 3695,33840341,Impact of manual removal of the placenta and intrauterine cleaning during elective cesarean delivery on maternal infectious morbidity and blood loss.,"OBJECTIVE to assess the impact of manual removal of the placenta and intrauterine cleaning during elective cesarean delivery on maternal infectious morbidity and blood loss. METHODS This prospective multicenter trial was conducted on 436 pregnant women at term who were intended for elective cesarean delivery and allocated into four groups; group 1 ( n  = 110) who underwent manual removal of the placenta with intrauterine cleaning, group 2 ( n  = 106) who underwent manual removal of the placenta without intrauterine cleaning, group 3 ( n  = 108) who underwent spontaneous placental delivery with intrauterine cleaning and group 4 ( n  = 112) who underwent spontaneous placental delivery without intrauterine cleaning. Maternal operative blood loss, the rate of endometritis and surgical site infections (SSIs) was assessed and recorded. RESULTS There was no significant difference between the four groups regarding drop of hemoglobin concentration, drop of hematocrit value, re-operation, re-admission to hospital, duration of hospital stay, the rate of endometritis and SSIs as well as maternal acceptability in terms of overall discomfort, overall satisfaction with delivery and recommendation to other women ( p  > .05). Intrauterine cleaning was associated with a significantly shorter duration of discharge of lochia and rapid return to daily activity compared to non-intrauterine cleaning ( p  < .05). CONCLUSION Manual removal of the placenta and intrauterine cleaning have no deleterious impact on maternal blood loss and infectious morbidity after elective cesarean section. Also, intrauterine cleaning was associated with faster cessation of lochia and faster return to daily activity.",2021,"There was no significant difference between the four groups regarding drop of hemoglobin concentration, drop of hematocrit value, re-operation, re-admission to hospital, duration of hospital stay, the rate of endometritis and SSIs as well as maternal acceptability in terms of overall discomfort, overall satisfaction with delivery and recommendation to other women ( p  > .05).","['after elective cesarean section', '436 pregnant women at term who were intended for elective cesarean delivery and allocated into four groups; group 1 ( n \u2009=\u2009110) who underwent']","['Intrauterine cleaning', 'placenta and intrauterine cleaning', 'manual removal of the placenta with intrauterine cleaning, group 2 ( n \u2009=\u2009106) who underwent manual removal of the placenta without intrauterine cleaning, group 3 ( n \u2009=\u2009108) who underwent spontaneous placental delivery with intrauterine cleaning and group 4 ( n \u2009=\u2009112) who underwent spontaneous placental delivery without intrauterine cleaning']","['faster cessation of lochia and faster return to daily activity', 'maternal blood loss and infectious morbidity', 'Maternal operative blood loss, the rate of endometritis and surgical site infections (SSIs', 'hemoglobin concentration, drop of hematocrit value, re-operation, re-admission to hospital, duration of hospital stay, the rate of endometritis and SSIs as well as maternal acceptability in terms of overall discomfort, overall satisfaction with delivery and recommendation', 'maternal infectious morbidity and blood loss', 'shorter duration of discharge of lochia and rapid return to daily activity']","[{'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C4517536', 'cui_str': '110'}]","[{'cui': 'C0694756', 'cui_str': 'Intrauterine'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0227855', 'cui_str': 'Lochia'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0014179', 'cui_str': 'Endometritis'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}]",436.0,0.04408,"There was no significant difference between the four groups regarding drop of hemoglobin concentration, drop of hematocrit value, re-operation, re-admission to hospital, duration of hospital stay, the rate of endometritis and SSIs as well as maternal acceptability in terms of overall discomfort, overall satisfaction with delivery and recommendation to other women ( p  > .05).","[{'ForeName': 'Haitham', 'Initials': 'H', 'LastName': 'Hamza', 'Affiliation': 'Department of Obstetrics and Gynecology, Menoufia University Hospital, Menoufia, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Rezk', 'Affiliation': 'Department of Obstetrics and Gynecology, Menoufia University Hospital, Menoufia, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Tharwat', 'Affiliation': 'Department of Obstetrics and Gynecology, Menoufia University Hospital, Menoufia, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Amgad', 'Affiliation': 'Department of Obstetrics and Gynecology, El Kabbari Central Hospital, Behira, Egypt.'}, {'ForeName': 'Ragab', 'Initials': 'R', 'LastName': 'Dawood', 'Affiliation': 'Department of Obstetrics and Gynecology, Menoufia University Hospital, Menoufia, Egypt.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2021.1875442'] 3696,33840336,"The efficacy of radiofrequency, intense pulsed light and carboxytherapy in facial rejuvenation.","Skin aging may be divided into intrinsic and extrinsic aging or photoaging. The first is a natural, slow and gradual process. The second is exacerbated by environmental factors such as improper exposure to sunlight. There are a myriad of therapeutic modalities that can improve photoaging. Intense pulsed light, radiofrequency and carboxytherapy are good procedural modalities to improve skin aging. This study aimed to evaluate and compare the efficacy and safety of IPL, RF, and carboxytherapy in facial rejuvenation. This study included 60 patients with facial wrinkles. Patients were divided into three groups. Group 1 was treated with IPL, group 2 was treated with radiofrequency while group 3 was treated with carboxytherapy. All patients received four sessions with 3-4 week interval and followed up after 3 months after the end of treatment. Patients were assessed by digital photographing and skin biopsies before and after treatment. There was a significant difference in the percentage of improvement and patients' satisfaction with more significance in group 1, followed by group 3 then group 2. IPL was the more effective, followed by carboxytherapy then RF at the end in facial rejuvenation. These results were confirmed by immunohistochemical expression of MMP1.",2021,"There was a significant difference in the percentage of improvement and patients' satisfaction with more significance in group 1, followed by group 3 then group 2.","['facial rejuvenation', '60 patients with facial wrinkles']","['radiofrequency, intense pulsed light and carboxytherapy', 'IPL', 'radiofrequency while group 3 was treated with carboxytherapy', 'IPL, RF, and carboxytherapy', 'Intense pulsed light, radiofrequency and carboxytherapy']","[""percentage of improvement and patients' satisfaction"", 'digital photographing and skin biopsies', 'immunohistochemical expression of MMP1']","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0035016', 'cui_str': 'Rejuvenation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0150866', 'cui_str': 'Biopsy of skin'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0127082', 'cui_str': 'Interstitial Collagenase'}]",60.0,0.00536916,"There was a significant difference in the percentage of improvement and patients' satisfaction with more significance in group 1, followed by group 3 then group 2.","[{'ForeName': 'Samia', 'Initials': 'S', 'LastName': 'Nassar', 'Affiliation': 'Department of Dermatology and Venereology, Tanta University Faculty of Medicine, Tanta, Egypt.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Assem', 'Affiliation': 'Department of Dermatology and Venereology, Tanta University Faculty of Medicine, Tanta, Egypt.'}, {'ForeName': 'Dareen', 'Initials': 'D', 'LastName': 'Mohamed', 'Affiliation': 'Pathology Department, Tanta University Faculty of Medicine, Tanta, Egypt.'}, {'ForeName': 'Ghada', 'Initials': 'G', 'LastName': 'Hassan', 'Affiliation': 'Department of Dermatology and Venereology, Tanta University Faculty of Medicine, Tanta, Egypt.'}]",Journal of cosmetic and laser therapy : official publication of the European Society for Laser Dermatology,['10.1080/14764172.2021.1880598'] 3697,33840312,A New Score for Quantifying Adherence to a Cancer-Preventive Mediterranean Diet.,"Herein a Mediterranean Cancer Preventive Diet Score (MCAP Score) is proposed to quantify adherence to both traditional Mediterranean fat intakes and the current dietary recommendations for cancer prevention. The scoring uses research-backed cutoff values, unlike other scores that are based on a population-specific median value. The MCAP score awards positive points for seven preventive food categories, including Mediterranean fats (monounsaturated fats, ω-3 fatty acids) associated with reduced adiposity, and negative points for four food categories associated with increased cancer risk, including ultra-processed foods. In a randomized trial of 120 persons at increased risk of colon cancer, the baseline MCAP Score averaged seven of 22 possible points. Counseling for a Healthy Diet or a Mediterranean Diet improved the score to either 11 or 13 points, respectively, and the highest score observed in any individual was 20 points. The MCAP Score was correlated with serum carotenoids and serum ω-3 fatty acids, and improvements in the score were associated with weight loss over six months of study. The MCAP Score is therefore proposed as a new method to assess adherence to a Mediterranean type of diet for cancer prevention using absolute criteria that will facilitate comparisons of dietary intakes across studies.",2021,"The MCAP Score was correlated with serum carotenoids and serum ω-3 fatty acids, and improvements in the score were associated with weight loss over six months of study.","['120 persons at increased risk of colon cancer, the baseline MCAP Score averaged seven of 22 possible points']",['Mediterranean Cancer Preventive Diet Score (MCAP Score'],"['serum carotenoids and serum ω-3 fatty acids', 'weight loss', 'MCAP Score']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332149', 'cui_str': 'Possible'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0007271', 'cui_str': 'Carotinoid'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",120.0,0.108535,"The MCAP Score was correlated with serum carotenoids and serum ω-3 fatty acids, and improvements in the score were associated with weight loss over six months of study.","[{'ForeName': 'Zora', 'Initials': 'Z', 'LastName': 'Djuric', 'Affiliation': 'Department of Family Medicine, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Samara', 'Initials': 'S', 'LastName': 'Rifkin', 'Affiliation': 'Department Internal Medicine, University of Michigan, Ann Arbor, Michigan, USA.'}]",Nutrition and cancer,['10.1080/01635581.2021.1909738'] 3698,33840310,The Effects of a News Literacy Video and Real-Time Corrections to Video Misinformation Related to Sunscreen and Skin Cancer.,"Given concerns about the persuasive power of video misinformation on social media for health topics, we test two techniques - exposure to a news literacy video and user corrections - to limit the effects on misperceptions. An online sample of American adults from August of 2019 was randomly assigned to view two simulated Facebook videos. The first video manipulated the presence of news literacy concepts. The second video either promoted sunscreen use or made inaccurate claims regarding its dangers; scrolling comments either debunked or did not address the sunscreen misinformation in the video. Our results demonstrate that video misinformation heightened beliefs in sunscreen myths and reduced acceptance of sunscreen facts and intentions to wear sunscreen compared to a promotional video. Real-time user corrections were partially successful in reducing the effects of the misinformation video on beliefs but not intentions. Additionally, exposure to a news literacy video did not inoculate people to the misinformation. We discuss the implications of these findings for best practices regarding correcting video misinformation on health topics.",2021,Our results demonstrate that video misinformation heightened beliefs in sunscreen myths and reduced acceptance of sunscreen facts and intentions to wear sunscreen compared to a promotional video.,['American adults from August of 2019'],['News Literacy Video and Real-Time Corrections'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0282425', 'cui_str': 'News'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",[],,0.0182162,Our results demonstrate that video misinformation heightened beliefs in sunscreen myths and reduced acceptance of sunscreen facts and intentions to wear sunscreen compared to a promotional video.,"[{'ForeName': 'Emily K', 'Initials': 'EK', 'LastName': 'Vraga', 'Affiliation': 'Hubbard School of Journalism and Mass Communication, University of Minnesota.'}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Bode', 'Affiliation': 'Communication, Culture, and Technology Program, Georgetown University.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Tully', 'Affiliation': 'School of Journalism and Mass Communication, University of Iowa.'}]",Health communication,['10.1080/10410236.2021.1910165'] 3699,33840246,Subcutaneous tunneling technique to improve outcomes for patients undergoing chemotherapy with peripherally inserted central catheters: a randomized controlled trial.,"OBJECTIVE To compare the value of the subcutaneous tunneling technique versus the normal technique in improving the outcomes of patients undergoing chemotherapy with peripherally inserted central catheters (PICCs). METHODS One hundred thirty patients were randomly divided into an experimental group (subcutaneous tunneling technique) and control group (normal technique) according to the PICC placement technique, and clinical data were compared between the groups. RESULTS In total, 129 PICCs were successfully inserted. Compared with the control group, the experimental group had a lower occurrence of complications after placement (especially catheter dislodgement: 3.1% vs. 15.4%, venous thrombosis: 3.1% vs. 15.4%, and wound oozing: 14.1% vs. 27.7%), lower occurrence of unscheduled PICC removal (3.1% vs. 13.8%), greater comfort during placement (14.16 ± 2.21 vs. 15.09 ± 2.49 on a scale ranging from 6 to 30 points, with higher scores indicating lower degrees of comfort), and lower costs of PICC maintenance (median (interquartile range) per-day maintenance cost: 13.90 (10.99-32.83) vs. 15.69 (10.51-57.46) Yuan). The occurrence of complications and amount of bleeding during placement were not significantly different between the two groups. CONCLUSIONS The subcutaneous tunneling technique can improve PICC placement by reducing complications and costs of maintenance with better patient comfort during placement.",2021,"Compared with the control group, the experimental group had a lower occurrence of complications after placement (especially catheter dislodgement: 3.1% vs. 15.4%, venous thrombosis: 3.1% vs. 15.4%, and wound oozing: 14.1% vs. 27.7%), lower occurrence of unscheduled PICC removal (3.1% vs. 13.8%), greater comfort during placement (14.16 ± 2.21 vs. 15.09 ± 2.49 on a scale ranging from 6 to 30 points, with higher scores indicating lower degrees of comfort), and lower costs of PICC maintenance (median (interquartile range) per-day maintenance cost: 13.90 (10.99-32.83) vs. 15.69 (10.51-57.46) Yuan).","['One hundred thirty patients', 'patients undergoing chemotherapy with peripherally inserted central catheters', 'patients undergoing chemotherapy with peripherally inserted central catheters (PICCs']","['subcutaneous tunneling technique', 'experimental group (subcutaneous tunneling technique) and control group (normal technique) according to the PICC placement technique', 'Subcutaneous tunneling technique']","['occurrence of complications and amount of bleeding', 'occurrence of complications', 'wound oozing', 'lower occurrence of unscheduled PICC removal', 'venous thrombosis', 'lower costs of PICC maintenance']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C2049629', 'cui_str': 'PICC Line Catheterization'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",130.0,0.183349,"Compared with the control group, the experimental group had a lower occurrence of complications after placement (especially catheter dislodgement: 3.1% vs. 15.4%, venous thrombosis: 3.1% vs. 15.4%, and wound oozing: 14.1% vs. 27.7%), lower occurrence of unscheduled PICC removal (3.1% vs. 13.8%), greater comfort during placement (14.16 ± 2.21 vs. 15.09 ± 2.49 on a scale ranging from 6 to 30 points, with higher scores indicating lower degrees of comfort), and lower costs of PICC maintenance (median (interquartile range) per-day maintenance cost: 13.90 (10.99-32.83) vs. 15.69 (10.51-57.46) Yuan).","[{'ForeName': 'Mao-Fang', 'Initials': 'MF', 'LastName': 'Xiao', 'Affiliation': 'School of Nursing, Sun Yat-sen University, Yuexiu District, Guangzhou, Guangdong, China.'}, {'ForeName': 'Cai-Qiong', 'Initials': 'CQ', 'LastName': 'Xiao', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Catheter Clinic, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Dai', 'Affiliation': 'Department of Nursing, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yu-Ying', 'Initials': 'YY', 'LastName': 'Fan', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Hui-Jiao', 'Initials': 'HJ', 'LastName': 'Cao', 'Affiliation': 'General Department, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Hui-Ying', 'Initials': 'HY', 'LastName': 'Qin', 'Affiliation': 'Department of Nursing, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.'}]",The Journal of international medical research,['10.1177/03000605211004517'] 3700,33840177,Comparison of the Ulnar Nerve Blockade between Intertruncal and Corner Pocket Approaches for Supraclavicular Block: A Randomized Controlled Trial.,"Background The corner pocket (CP) approach for supraclavicular block (SCB) prevents ulnar nerve (UN) sparing due to needle proximity of lower trunk. Improved ultrasound resolution has suggested that the intertruncal (IT) approach is a suitable alternative method. However, the comparative efficiency of these two approaches on UN block has not been evaluated. Methods Sixty patients were randomized to undergo SCB using the ultrasound-guided CP or IT approach. For lower trunk blockade, 10 mL of local anesthetic agents (1:1 mixture of 0.75% ropivacaine and 1% lidocaine) were injected in the CP (CP approach) or between the lower and middle trunk (IT approach). Additional 15mL was injected identically to block the middle and upper trunks in both groups. Sensory and motor blockade was evaluated after intervention. Results Complete sensory blockade (75.9% [22/29] vs 43.3% [13/30], P = 0.023) and complete motor blockade (82.8% [24/29] vs 50.0% [15/30], P = 0.017) of the UN at 15 min after SCB were significantly more frequent in the IT than in the CP group. Sensory block onset time of UN was significantly shorter in the IT compared to the CP group (15.0 [10.0; 15.0] min vs 20.0 [15.0; 20.0] min; P = 0.011). Conclusions The IT approach provided a more rapid onset of sensory and motor block of the UN than the CP approach. These results suggest that the IT approach is a suitable alternative to the CP approach and can provide faster surgical readiness.",2021,"Sensory block onset time of UN was significantly shorter in the IT compared to the CP group (15.0 [10.0; 15.0] min vs 20.0 [15.0; 20.0] min; P = 0.011). ","['Supraclavicular Block', 'Methods\n\n\nSixty patients']","['SCB', 'ropivacaine', 'CP', 'lidocaine', '\n\n\nThe corner pocket (CP) approach for supraclavicular block (SCB']","['Complete sensory blockade', 'complete motor blockade', 'Sensory and motor blockade', 'Sensory block onset time of UN']","[{'cui': 'C0394699', 'cui_str': 'Brachial plexus block by supraclavicular approach'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0394699', 'cui_str': 'Brachial plexus block by supraclavicular approach'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0041602', 'cui_str': 'Structure of ulnar nerve'}]",60.0,0.0381871,"Sensory block onset time of UN was significantly shorter in the IT compared to the CP group (15.0 [10.0; 15.0] min vs 20.0 [15.0; 20.0] min; P = 0.011). ","[{'ForeName': 'Yumin', 'Initials': 'Y', 'LastName': 'Jo', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chungnam National University Hospital.'}, {'ForeName': 'Jiho', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chungnam National University Hospital.'}, {'ForeName': 'Chahyun', 'Initials': 'C', 'LastName': 'Oh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chungnam National University Hospital.'}, {'ForeName': 'Woosuk', 'Initials': 'W', 'LastName': 'Chung', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chungnam National University Hospital.'}, {'ForeName': 'Seunghyun', 'Initials': 'S', 'LastName': 'Song', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chungnam National University Hospital.'}, {'ForeName': 'Jieun', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chungnam National University Hospital.'}, {'ForeName': 'Hansol', 'Initials': 'H', 'LastName': 'Kang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chungnam National University Hospital.'}, {'ForeName': 'Youngkwon', 'Initials': 'Y', 'LastName': 'Ko', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chungnam National University Hospital.'}, {'ForeName': 'Yoon-Hee', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chungnam National University Hospital.'}, {'ForeName': 'Boohwi', 'Initials': 'B', 'LastName': 'Hong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chungnam National University Hospital.'}]",Korean journal of anesthesiology,['10.4097/kja.21028'] 3701,33840150,2-Minute Tidal Breathing Methacholine Bronchial Challenge: Comparison of Two Jet Nebulizers.,"BACKGROUND The American Thoracic Society (ATS) guideline for methacholine challenge testing (MCT) recommended using the English Wright (EW) nebulizer. However, other brands of nebulizers are also indicated to be acceptable for this technique, but further validation of nebulizer performance is recommended. OBJECTIVE To compare the methacholine provocation concentration causing a 20% fall in forced expiratory volume in 1 second (PC 20 -FEV 1 ) measured by using EW nebulizer and DV 646 nebulizer. METHODS Subjects were randomly assigned to undergo 2-minute tidal breathing methacholine challenge with either EW or DV 646 nebulizer on two separate days, which were at least 24 hours but not more than 7 days apart. The above procedure was repeated for each subject in one month, but the nebulizers were selected in a reverse order. RESULTS 15 mild and stable asthma patients finished this study. The geometric means (SD) of methacholine PC 20 measured with using EW and DV 646 nebulizers were 1.82 (6.38) mg/ml versus 0.83 (1.82) mg/ml, respectively in the initial two visits and 2.56 (6.29) mg/ml versus 0.78 (1.40) mg/ml in the following two visits in asthma (both P < 0.05). There are well correlations between PC20-EW1 and PC20-EW2 (r=0.99, p<0.01), PC20-DV1 and PC20-DV2 (r=0.88, p<0.01), and between PC20-EW1 and PC20-DV1 (r=0.91, p<0.01), PC20-EW2 and logPC20-DV2 (r=0.78, p<0.01). CONCLUSIONS PC 20 -FEV 1 measured by using the two conventional jet nebulizers was both repeatable and the results were highly correlated.",2021,mg/ml in the following two visits in asthma (both P < 0.05).,['Subjects'],"['tidal breathing methacholine challenge with either EW or DV 646 nebulizer', 'English Wright (EW) nebulizer']",['forced expiratory volume'],[],"[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0430567', 'cui_str': 'Methacholine challenge'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C1261259', 'cui_str': 'Wright stain'}, {'cui': 'C0027524', 'cui_str': 'Nebulizer'}]","[{'cui': 'C0016529', 'cui_str': 'Forced expired volume'}]",646.0,0.0321704,mg/ml in the following two visits in asthma (both P < 0.05).,"[{'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Department of Allergy and Clinical Immunology, Guangzhou Institute of Respiratory Health, State Key Lab of Respiratory Disease, The first affiliated hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Guangzhou Institute of Respiratory Health, State Key Lab of Respiratory Disease, The first affiliated hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Yanqing', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': 'Guangzhou Institute of Respiratory Health, State Key Lab of Respiratory Disease, The first affiliated hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Jiaying', 'Initials': 'J', 'LastName': 'An', 'Affiliation': 'Guangzhou Institute of Respiratory Health, State Key Lab of Respiratory Disease, The first affiliated hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Allergy and Clinical Immunology, Guangzhou Institute of Respiratory Health, State Key Lab of Respiratory Disease, The first affiliated hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Jinping', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'Guangzhou Institute of Respiratory Health, State Key Lab of Respiratory Disease, The first affiliated hospital of Guangzhou Medical University, Guangzhou, China.'}]",The clinical respiratory journal,['10.1111/crj.13374'] 3702,33840139,The CONCERT-HF Trial: A Sweet and Sour Symphony.,,2021,,[],[],[],[],[],[],,0.14187,,"[{'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Bayes-Genis', 'Affiliation': 'Heart Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.'}]",European journal of heart failure,['10.1002/ejhf.2188'] 3703,33840086,Holmium LASER in Comparison with Transurethral Resection of the Bladder Tumor for Non-muscle Invasive Bladder Cancer: Randomized Clinical Trial with 18-month Follow-up.,"PURPOSE To evaluate the safety and efficacy of holmium LASER resection of the bladder tumor (HoLRBT) vs. transurethral resection of bladder tumor (TURBT) as the first treatment modality for non-muscle-invasive bladder cancer (NMIBC). MATERIALS AND METHODS Eighty-eight patients with primary non-muscle invasive bladder cancer were allocated randomly in two groups who were treated with HoLRBT or TURBT. The intraoperative and postoperative characteristics and complications of the HoLRBT and TURBT groups were compared. The data of operation time, obturator nerve reflex rate, bladder perforation, bladder irrigation, catheterization time, hospital stay, and 1, 3, 6, 12, 18 months recurrence free survivals were considered in two groups. RESULTS There was not significant difference in operative duration among the two groups. Compared with the TURBT group, HoLRBT group had less intraoperative and postoperative complications, including obturator nerve reflex, transient hematuria and postoperative bladder irritation. There were no significant differences among the two groups in the transfusion rate and occurrence of urethral strictures. Patients in the HoLRBT group had less catheterization and hospitalization time in comparison to those in the TURBT group. There were no significant differences in the overall recurrence rate among the TURBT and HoLRBT groups. CONCLUSION HoLRBT can be regarded as a safe and efficient method with several advantages over TURBT. HoLRBT can be used as an alternative procedure for TURBT in patients with non-muscle invasive bladder cancer.",2021,"Compared with the TURBT group, HoLRBT group had less intraoperative and postoperative complications, including obturator nerve reflex, transient hematuria and postoperative bladder irritation.","['patients with non-muscle invasive bladder cancer', 'non-muscle-invasive bladder cancer (NMIBC', 'Non-muscle Invasive Bladder Cancer', 'Eighty-eight patients with primary non-muscle invasive bladder cancer']","['holmium LASER resection of the bladder tumor (HoLRBT) vs. transurethral resection of bladder tumor (TURBT', 'HoLRBT', 'HoLRBT or TURBT', 'Holmium LASER', 'Transurethral Resection', 'TURBT']","['safety and efficacy', 'operation time, obturator nerve reflex rate, bladder perforation, bladder irrigation, catheterization time, hospital stay', 'transfusion rate and occurrence of urethral strictures', 'catheterization and hospitalization time', 'recurrence free survivals', 'intraoperative and postoperative complications, including obturator nerve reflex, transient hematuria and postoperative bladder irritation', 'overall recurrence rate', 'operative duration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}, {'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0005695', 'cui_str': 'Neoplasm of bladder'}, {'cui': 'C0401496', 'cui_str': 'Transurethral resection of bladder neoplasm'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0028783', 'cui_str': 'Structure of obturator nerve'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0434133', 'cui_str': 'Perforation of bladder'}, {'cui': 'C0194423', 'cui_str': 'Irrigation of urinary bladder'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0041974', 'cui_str': 'Urethral stenosis'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0018965', 'cui_str': 'Blood in urine'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1261562', 'cui_str': 'Idiopathic detrusor overactivity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",88.0,0.0801776,"Compared with the TURBT group, HoLRBT group had less intraoperative and postoperative complications, including obturator nerve reflex, transient hematuria and postoperative bladder irritation.","[{'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Razzaghi', 'Affiliation': 'LASER Application in Medical Sciences Research Center (LAMSRC), Shahid Beheshti University of Medical Sciences. mr_razaghi@yahoo.com.'}, {'ForeName': 'Mohammad Mohsen', 'Initials': 'MM', 'LastName': 'Mazloomfard', 'Affiliation': 'LASER Application in Medical Sciences Research Center (LAMSRC), Shahid Beheshti University of Medical Sciences. mazloomfard@yahoo.com.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Yavar', 'Affiliation': 'LASER Application in Medical Sciences Research Center (LAMSRC), Shahid Beheshti University of Medical Sciences.'}, {'ForeName': 'Sheida', 'Initials': 'S', 'LastName': 'Malekian', 'Affiliation': 'Department of Internal Medicine, Tajrish Hospital, Shahid Beheshti University of Medical Sciences.'}, {'ForeName': 'Pouria', 'Initials': 'P', 'LastName': 'Mousapour', 'Affiliation': 'LASER Application in Medical Sciences Research Center (LAMSRC), Shahid Beheshti University of Medical Sciences. Mousapour@gmail.com.'}]",Urology journal,['10.22037/uj.v18i.6319'] 3704,33840085,A Randomized Crossover Pilot Study Examining the Effect of Carvedilol and Terazosin plus Enalapril on Urinary Symptoms of Patients with Hypertension and Benign Prostatic Hyperplasia.,"PURPOSE The present study aims to assess and compare the effects of carvedilol and terazosin plus enalapril on lower urinary tract symptoms (LUTS), the urine flow, and blood pressure (BP) in patients with moderate hypertension (HTN) and benign prostatic hyperplasia (BPH). MATERIALS AND METHODS In this randomized crossover trial, a total of 40 men with HTN and LUTS symptoms were enrolled. The first group was treated with carvedilol, and the second one received terazosin plus enalapril. After eight weeks of treatment, the patients experienced a one-month washout period, and the treatments changed and continued for eight weeks. To diagnose BPH in the study, the international prostate symptom score (IPSS) questionnaire was used. Moreover, the prostate-specific antigen (PSA), the post-void residual (PVR) urine volume, and the maximum urinary flow rate (Q-max using the uroflowmetry test) were measured. RESULTS Effect assessment results in this crossover trial illustrated neither carryover effects nor significant treatment effects on all primary outcomes (P > 0.05). Moreover, the results for the period effect indicated a significant reduction in BP (systolic and diastolic), PVR, and IPSS, yet a significant raise in Qmax. CONCLUSION The effects of carvedilol are similar to those of the combination of terazosin and enalapril in patients with moderate HTN and BPH in controlling LUTS. Carvedilol could be used as an appropriative drug in patients with moderate HTN and cardiac problems with LUTS of BPH. Further studies are recommended to be conducted to investigate and compare the efficacy of carvedilol with that of other alpha-blockers with a larger sample size and over a longer period of time.",2021,The effects of carvedilol are similar to those of the combination of terazosin and enalapril in patients with moderate HTN and BPH in controlling LUTS.,"['patients with moderate HTN and BPH in controlling LUTS', '40 men with HTN and LUTS symptoms were enrolled', 'Patients with Hypertension and Benign Prostatic Hyperplasia', 'patients with moderate HTN and cardiac problems with LUTS of BPH', 'patients with moderate hypertension (HTN) and benign prostatic hyperplasia (BPH']","['carvedilol and terazosin plus enalapril', 'Carvedilol and Terazosin plus Enalapril', 'carvedilol', 'terazosin and enalapril', 'terazosin plus enalapril', 'Carvedilol']","['BP (systolic and diastolic), PVR, and IPSS', 'international prostate symptom score (IPSS) questionnaire', 'Urinary Symptoms', 'lower urinary tract symptoms (LUTS), the urine flow, and blood pressure (BP', 'maximum urinary flow rate (Q-max using the uroflowmetry test']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]","[{'cui': 'C0054836', 'cui_str': 'carvedilol'}, {'cui': 'C0076107', 'cui_str': 'Terazosin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0232851', 'cui_str': 'Flow of urine'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0429783', 'cui_str': 'Urinary flow rate'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0200008', 'cui_str': 'Uroflowmetry'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",40.0,0.0170843,The effects of carvedilol are similar to those of the combination of terazosin and enalapril in patients with moderate HTN and BPH in controlling LUTS.,"[{'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Farshi', 'Affiliation': 'Associated Professor of Urology, Department of Urology, Tabriz University of Medical Sciences, Tabriz, Iran. farshiar@yahoo.com.'}, {'ForeName': 'Nooriyeh', 'Initials': 'N', 'LastName': 'DalirAkbari', 'Affiliation': 'Urology Resident, Department of Urology, Tabriz University of Medical Sciences, Tabriz, Iran. dr.neda67@gmail.com.'}, {'ForeName': 'Afshar', 'Initials': 'A', 'LastName': 'Zomorrodi', 'Affiliation': 'Associated Professor of Urology, Department of Urology, Tabriz University of Medical Sciences, Tabriz, Iran. zomirrodiaf@gmail.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Khalili', 'Affiliation': 'Ph.D. in Nutrition, Multiple Sclerosis Research Center, Neuroscience institute, Tehran University of Medical Sciences, Tehran, Iran. nutrifoodkhalili@gmail.com.'}]",Urology journal,['10.22037/uj.v18i.5678'] 3705,33840060,"Ultrasound-Guided Continuous Thoracic Paravertebral Infusion of Methylene Blue in the Treatment of Postherpetic Neuralgia: A Prospective, Randomized, Controlled Study.","INTRODUCTION Postherpetic neuralgia (PHN) is the most common complication of herpes zoster. Methylene blue (MB) is an inhibitor of nitric oxide synthesis with potentially analgesic and anti-inflammatory properties. Studies have demonstrated that thoracic paravertebral single MB injection is effective in treating chronic pain. However, there are rare reports of the efficacy of continuous thoracic paravertebral infusion of MB for pain management in PHN patients. The purpose of this study was to evaluate the therapeutic effects of continuous thoracic paravertebral infusion of MB on PHN. METHODS A total of 104 PHN patients were randomly divided into two groups: the control group (continuous thoracic paravertebral infusion of 5% lidocaine in a total volume of 300 ml) and the MB group (continuous thoracic paravertebral infusion of 5% lidocaine plus 0.2% MB in a total volume of 300 ml). All patients were evaluated using the Numerical Rating Scale (NRS), Insomnia Severity Index (ISI), Patient Health Questionnaire-9 (PHQ-9), 36-Item Short-Form Health Survey (SF-36), and medication doses before and after the procedure. The effective treatment rate and adverse complications were recorded 6 months after the procedure. RESULTS In both groups, the NRS scores, ISI scores, PHQ-9 scores, and rescue medication dosages were significantly decreased at different time points after treatment compared to baseline, while the SF-36 scores were evidently improved at different time points after treatment compared to baseline. Compared with the control group, the MB group had significantly reduced NRS scores, ISI scores, PHQ-9 scores, and rescue medication dosages at each observation time point. Furthermore, the SF-36 scores in the MB group were significantly higher than those in the control group at each observation time point. The total effective treatment rate of the MB group was higher than that of the control group 6 months after the procedure. No severe adverse complications were observed in either group. CONCLUSIONS Ultrasound-guided continuous thoracic paravertebral infusion with MB is a safe and effective therapy for PHN. Continuous infusion with MB can significantly reduce pain intensity, improve pain-related depression, increase quality of life, and decrease the amount of rescue medicine with no serious adverse complications.",2021,"Compared with the control group, the MB group had significantly reduced NRS scores, ISI scores, PHQ-9 scores, and rescue medication dosages at each observation time point.","['PHN patients', '104 PHN patients', 'Postherpetic Neuralgia']","['Methylene blue (MB', 'Ultrasound-Guided Continuous Thoracic Paravertebral Infusion of Methylene Blue', 'thoracic paravertebral single MB injection', 'control group (continuous thoracic paravertebral infusion of 5% lidocaine', 'MB group (continuous thoracic paravertebral infusion of 5% lidocaine plus 0.2% MB']","['Numerical Rating Scale (NRS), Insomnia Severity Index (ISI), Patient Health Questionnaire-9 (PHQ-9), 36-Item Short-Form Health Survey (SF-36), and medication doses', 'NRS scores, ISI scores, PHQ-9 scores, and rescue medication dosages', 'pain intensity, improve pain-related depression, increase quality of life', 'effective treatment rate and adverse complications', 'total effective treatment rate', 'severe adverse complications', 'SF-36 scores']","[{'cui': 'C0032768', 'cui_str': 'Postherpetic neuralgia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517527', 'cui_str': '104'}]","[{'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C4081241', 'cui_str': 'Methylene blue Injection'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4517436', 'cui_str': '0.2'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4706228', 'cui_str': 'ISI (Insomnia Severity Index) score'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",104.0,0.030953,"Compared with the control group, the MB group had significantly reduced NRS scores, ISI scores, PHQ-9 scores, and rescue medication dosages at each observation time point.","[{'ForeName': 'Mingxia', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Shanghai East Hospital, Tongji University School of Medicine, 150 Jimo Rd, Shanghai, 200120, China.'}, {'ForeName': 'Jinyuan', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Shanghai East Hospital, Tongji University School of Medicine, 150 Jimo Rd, Shanghai, 200120, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': 'Department of Anesthesiology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, 507 Zhengmin Rd, Shanghai, 200433, China.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Shanghai East Hospital, Tongji University School of Medicine, 150 Jimo Rd, Shanghai, 200120, China.'}, {'ForeName': 'Yiguo', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, 507 Zhengmin Rd, Shanghai, 200433, China.'}, {'ForeName': 'Huimin', 'Initials': 'H', 'LastName': 'Deng', 'Affiliation': 'Department of Anesthesiology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, 507 Zhengmin Rd, Shanghai, 200433, China.'}, {'ForeName': 'Mansi', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, 507 Zhengmin Rd, Shanghai, 200433, China.'}, {'ForeName': 'Xiuqin', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Shanghai East Hospital, Tongji University School of Medicine, 150 Jimo Rd, Shanghai, 200120, China.'}, {'ForeName': 'Qingxiang', 'Initials': 'Q', 'LastName': 'Meng', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Shanghai East Hospital, Tongji University School of Medicine, 150 Jimo Rd, Shanghai, 200120, China.'}, {'ForeName': 'Yuanli', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Shanghai East Hospital, Tongji University School of Medicine, 150 Jimo Rd, Shanghai, 200120, China.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Liao', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Shanghai East Hospital, Tongji University School of Medicine, 150 Jimo Rd, Shanghai, 200120, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Lv', 'Affiliation': 'Department of Anesthesiology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, 507 Zhengmin Rd, Shanghai, 200433, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, 507 Zhengmin Rd, Shanghai, 200433, China. yanghaozunyi@sina.com.'}, {'ForeName': 'Xiangrui', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Shanghai East Hospital, Tongji University School of Medicine, 150 Jimo Rd, Shanghai, 200120, China. wangxiangruirjyy@sina.com.'}]",Pain and therapy,['10.1007/s40122-021-00265-w'] 3706,33839979,"Correction to: Postoperative Adjuvant Transarterial Infusion Chemotherapy with FOLFOX Could Improve Outcomes of Hepatocellular Carcinoma Patients with Microvascular Invasion: A Preliminary Report of a Phase III, Randomized Controlled Clinical Trial.",,2021,,['Hepatocellular Carcinoma Patients with Microvascular Invasion'],['FOLFOX'],[],"[{'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}]",[],[],,0.249666,,"[{'ForeName': 'Shaohua', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Mei', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Qiaoxuan', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer 3Medicine, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Zhixing', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': ""State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer 3Medicine, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Lianghe', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Yihong', 'Initials': 'Y', 'LastName': 'Ling', 'Affiliation': ""State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer 3Medicine, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Minshan', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Lie', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': ""State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer 3Medicine, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Wenping', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Yuhua', 'Initials': 'Y', 'LastName': 'Wen', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China. weiwei@sysucc.org.cn.""}, {'ForeName': 'Rongping', 'Initials': 'R', 'LastName': 'Guo', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China. guorp@sysucc.org.cn.""}]",Annals of surgical oncology,['10.1245/s10434-021-09813-2'] 3707,33839950,Jumping rope and whole-body vibration program effects on bone values in Olympic artistic swimmers.,"INTRODUCTION Artistic swimming seems not to benefit bone development like other out-of-water physical activities. To increase bone acquisition, artistic swimming should combine water training with weight-bearing impact or strength activities. Artistic swimmers can be a population at risk of developing osteopenia and osteoporosis in later life. The aim of the present study was to evaluate the effects of a training program on bone mineral density (BMD), bone mineral content (BMC) and body composition in an Olympic artistic swimming team. METHODS Sixteen women aged 17-21 years, who train 30 h/week, at the Olympic Training Centre (Barcelona, Spain), were followed up over two seasons. The 1st season involved regular artistic swimming training without specific training to reduce the risk of osteopenia. The exercise intervention, jumping rope and whole-body vibration, was added in the 2nd season. The protocol included 20 min of training 2 days per week, over a 22-week period. Dual energy x-ray absorptiometry measured the bone variables and body composition. The daily diet, medical history and bone turnover markers were evaluated. RESULTS The intervention program increased BMD on lumbar spine (2.10%, p = 0.002), total hip (2.07%, p = 0.001), and femoral neck (2.39%, p = 0.02). Lower limb's fat mass decreased (10.17%, p = 0.038). No significant differences were found for any of the measured anthropometric characteristics between both time points in the 1st season. In conclusions, combined jump rope and vibration should be considered to reduce the risk of bone damage in artistic swimmers.",2021,"The intervention program increased BMD on lumbar spine (2.10%, p = 0.002), total hip (2.07%, p = 0.001), and femoral neck (2.39%, p = 0.02).","['Artistic swimmers', 'artistic swimmers', 'Olympic artistic swimmers', 'Sixteen women aged 17-21\xa0years, who train 30\xa0h/week, at the Olympic Training Centre (Barcelona, Spain), were followed up over two seasons']","['regular artistic swimming training without specific training', 'training program', 'exercise intervention, jumping rope and whole-body vibration', 'Jumping rope and whole-body vibration program']","['bone mineral density (BMD), bone mineral content (BMC) and body composition', 'femoral neck', ""Lower limb's fat mass"", 'risk of osteopenia', 'BMD on lumbar spine', 'bone values', 'total hip']","[{'cui': 'C0450068', 'cui_str': 'Swimmer'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0557814', 'cui_str': 'Training center'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}]",16.0,0.00537222,"The intervention program increased BMD on lumbar spine (2.10%, p = 0.002), total hip (2.07%, p = 0.001), and femoral neck (2.39%, p = 0.02).","[{'ForeName': 'Montse', 'Initials': 'M', 'LastName': 'Bellver', 'Affiliation': 'Centro de Alto Rendimiento (CAR), Av. Alcalde Barnils s/nSant Cugat del Valles, 08173, Barcelona, Spain. mbellver@car.edu.'}, {'ForeName': 'Franchek', 'Initials': 'F', 'LastName': 'Drobnic', 'Affiliation': 'Centro de Alto Rendimiento (CAR), Av. Alcalde Barnils s/nSant Cugat del Valles, 08173, Barcelona, Spain.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Jovell', 'Affiliation': 'Consorci Sanitari de Terrassa (CST), Carretera de Torrebonica s/n, 08227, Terrassa, Barcelona, Spain.'}, {'ForeName': 'Ventura', 'Initials': 'V', 'LastName': 'Ferrer-Roca', 'Affiliation': 'Centro de Alto Rendimiento (CAR), Av. Alcalde Barnils s/nSant Cugat del Valles, 08173, Barcelona, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Abalos', 'Affiliation': 'LCAFE School of Physical Education and Sports Sciences, Sc Wiesbaden 1911 e.v, Wiesbaden, Germany.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Del Rio', 'Affiliation': 'CETIR Centre Medic, c/Londres, 6, 08029, Barcelona, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Trilla', 'Affiliation': 'Hospital Clinic, University of Barcelona, c/Villarroel, 170, 08036, Barcelona, Spain.'}]",Journal of bone and mineral metabolism,['10.1007/s00774-021-01224-3'] 3708,33839938,Using deep learning to predict microvascular invasion in hepatocellular carcinoma based on dynamic contrast-enhanced MRI combined with clinical parameters.,"PURPOSE Microvascular invasion (MVI) is a critical determinant of the early recurrence and poor prognosis of patients with hepatocellular carcinoma (HCC). Prediction of MVI status is clinically significant for the decision of treatment strategies and the assessment of patient's prognosis. A deep learning (DL) model was developed to predict the MVI status and grade in HCC patients based on preoperative dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) and clinical parameters. METHODS HCC patients with pathologically confirmed MVI status from January to December 2016 were enrolled and preoperative DCE-MRI of these patients were collected in this study. Then they were randomly divided into the training and testing cohorts. A DL model with eight conventional neural network (CNN) branches for eight MRI sequences was built to predict the presence of MVI, and further combined with clinical parameters for better prediction. RESULTS Among 601 HCC patients, 376 patients were pathologically MVI absent, and 225 patients were MVI present. To predict the presence of MVI, the DL model based only on images achieved an area under curve (AUC) of 0.915 in the testing cohort as compared to the radiomics model with an AUC of 0.731. The DL combined with clinical parameters (DLC) model yielded the best predictive performance with an AUC of 0.931. For the MVI-grade stratification, the DLC models achieved an overall accuracy of 0.793. Survival analysis demonstrated that the patients with DLC-predicted MVI status were associated with the poor overall survival (OS) and recurrence-free survival (RFS). Further investigation showed that hepatectomy with the wide resection margin contributes to better OS and RFS in the DLC-predicted MVI present patients. CONCLUSION The proposed DLC model can provide a non-invasive approach to evaluate MVI before surgery, which can help surgeons make decisions of surgical strategies and assess patient's prognosis.",2021,The DL combined with clinical parameters (DLC) model yielded the best predictive performance with an AUC of 0.931.,"['patients with hepatocellular carcinoma (HCC', 'HCC patients with pathologically confirmed MVI status from January to December 2016 were enrolled and preoperative DCE-MRI of these patients were collected in this study', '601 HCC patients, 376 patients were pathologically MVI absent, and 225 patients were MVI present']",['deep learning'],['overall survival (OS) and recurrence-free survival (RFS'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}]",376.0,0.0524524,The DL combined with clinical parameters (DLC) model yielded the best predictive performance with an AUC of 0.931.,"[{'ForeName': 'Danjun', 'Initials': 'D', 'LastName': 'Song', 'Affiliation': ""Department of Liver Surgery, Key Laboratory of Carcinogenesis and Cancer Invasion of Ministry of Education, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Yueyue', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Digital Medical Research Center, School of Basic Medical Science, Fudan University, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Department of Radiology, Zhongshan Hospital, Fudan University, 200032, Shanghai, People's Republic of China.""}, {'ForeName': 'Yining', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Liver Surgery, Key Laboratory of Carcinogenesis and Cancer Invasion of Ministry of Education, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Jiabin', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': ""Department of Liver Surgery, Key Laboratory of Carcinogenesis and Cancer Invasion of Ministry of Education, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Zhu', 'Affiliation': ""Department of Liver Surgery, Key Laboratory of Carcinogenesis and Cancer Invasion of Ministry of Education, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Minzhi', 'Initials': 'M', 'LastName': 'Lv', 'Affiliation': 'Department of Biostatistics, Zhongshan Hospital, Fudan University, Shanghai, 200032, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Gao', 'Affiliation': ""Department of Liver Surgery, Key Laboratory of Carcinogenesis and Cancer Invasion of Ministry of Education, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': ""Department of Liver Surgery, Key Laboratory of Carcinogenesis and Cancer Invasion of Ministry of Education, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': ""Department of Liver Surgery, Key Laboratory of Carcinogenesis and Cancer Invasion of Ministry of Education, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Shengxiang', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': ""Department of Radiology, Zhongshan Hospital, Fudan University, 200032, Shanghai, People's Republic of China. raoxray@163.com.""}, {'ForeName': 'Manning', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""Digital Medical Research Center, School of Basic Medical Science, Fudan University, Shanghai, 200032, People's Republic of China. mnwang@fudan.edu.cn.""}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Liver Surgery, Key Laboratory of Carcinogenesis and Cancer Invasion of Ministry of Education, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, 200032, People's Republic of China. xiaoyingwang@fudan.edu.cn.""}]",Journal of cancer research and clinical oncology,['10.1007/s00432-021-03617-3'] 3709,33839923,Association between anemia and mortality in patients with acute coronary syndrome treated with percutaneous coronary intervention and contemporary lipid-lowering therapy.,"Despite a clear correlation between anemia and mortality in patients with the acute coronary syndrome (ACS), anemia as a mortality predictor in patients with ACS-receiving early invasive strategy and contemporary lipid-lowering therapy has not been examined. Therefore, we aimed to evaluate the association between anemia and mortality in ACS patients treated with acute revascularization and contemporary lipid-lowering treatment. This was a post-hoc study of the Heart Institute of Japan-Proper level of Lipid-Lowering with Pitavastatin and Ezetimibe in acute coronary syndrome study, in which ACS patients with dyslipidemia were randomized to receive either pitavastatin and ezetimibe or pitavastatin monotherapy. The success rate of primary percutaneous coronary intervention (PCI) was 95.2%. Eligible patients were divided into two groups: patients with anemia (anemia group) or without anemia (non-anemia group). Anemia was defined using the World Health Organization definition hemoglobin < 12 g/dL for women and < 13 g/dL for men. We compared the mortality between the two groups using propensity scores derived from 17 baseline variables. We identified 1721 eligible patients, including 420 (24.4%) in the anemia group and 1301 (75.6%) in the non-anemia group. One-to-one propensity score-matching created 381 pairs. Both unmatched and matched analyses found significantly high mortality in the anemia group compared to the non-anemia group (unmatched 12.3% vs. 3.8%, log-rank p < 0.01; matched 11.5% vs. 6.3%, log-rank p = 0.01). In ACS patients treated with an early invasive strategy era with a high PCI success rate and concurrent contemporary lipid-lowering management, all-cause mortality was still significantly higher in anemic patients than in non-anemic patients.Trial registration: Clinical trial registration URL: http://www.umin.ac.jp/ctr . Unique identifier: UMIN00000274.",2021,"Both unmatched and matched analyses found significantly high mortality in the anemia group compared to the non-anemia group (unmatched 12.3% vs. 3.8%, log-rank p < 0.01; matched 11.5% vs. 6.3%, log-rank p = 0.01).","['1721 eligible patients, including 420 (24.4%) in the anemia group and 1301 (75.6%) in the non-anemia group', 'patients with the acute coronary syndrome (ACS', 'Eligible patients were divided into two groups: patients with anemia (anemia group) or without anemia (non-anemia group', 'ACS patients treated with acute revascularization and contemporary lipid-lowering treatment', 'patients with acute coronary syndrome treated with', 'ACS patients with dyslipidemia']","['pitavastatin and ezetimibe or pitavastatin monotherapy', 'Pitavastatin and Ezetimibe', 'percutaneous coronary intervention and contemporary lipid-lowering therapy']","['success rate', 'Anemia', 'high mortality', 'mortality', 'anemia and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517774', 'cui_str': '420'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}]","[{'cui': 'C1101838', 'cui_str': 'pitavastatin'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}]","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",1721.0,0.0196115,"Both unmatched and matched analyses found significantly high mortality in the anemia group compared to the non-anemia group (unmatched 12.3% vs. 3.8%, log-rank p < 0.01; matched 11.5% vs. 6.3%, log-rank p = 0.01).","[{'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Ogiso', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, 8-1, Kawada-Cho, Shinjuku, Tokyo, 162-8666, Japan.""}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Yamaguchi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, 8-1, Kawada-Cho, Shinjuku, Tokyo, 162-8666, Japan. j.yamaguchi0110@gmail.com.""}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Otsuki', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, 8-1, Kawada-Cho, Shinjuku, Tokyo, 162-8666, Japan.""}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Arashi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, 8-1, Kawada-Cho, Shinjuku, Tokyo, 162-8666, Japan.""}, {'ForeName': 'Haruki', 'Initials': 'H', 'LastName': 'Sekiguchi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, 8-1, Kawada-Cho, Shinjuku, Tokyo, 162-8666, Japan.""}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ogawa', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, 8-1, Kawada-Cho, Shinjuku, Tokyo, 162-8666, Japan.""}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Hagiwara', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, 8-1, Kawada-Cho, Shinjuku, Tokyo, 162-8666, Japan.""}]",Heart and vessels,['10.1007/s00380-021-01850-x'] 3710,33839919,"A weight-loss Mediterranean diet/lifestyle intervention ameliorates inflammation and oxidative stress in patients with obstructive sleep apnea: results of the ""MIMOSA"" randomized clinical trial.","PURPOSE Inflammation and oxidative stress are implicated in obstructive sleep apnea (OSA) pathophysiology. We aimed at exploring whether the combination of a weight-loss Mediterranean diet/lifestyle intervention with OSA standard care, i.e., continuous positive airway pressure (CPAP) prescription, can lead to greater improvements in inflammation and oxidative stress, compared to standard care alone. METHODS This was a randomized controlled clinical trial in 187 adult, overweight patients with moderate-to-severe OSA. Participants were randomized to a standard care (SCG, n = 65), a Mediterranean diet (MDG, n = 62) or a Mediterranean lifestyle group (MLG, n = 60). All groups received OSA standard care. Intervention arms participated in a 6-month behavioral weight-loss intervention based on the Mediterranean diet, while the MLG also received counselling on physical activity and sleep habits. RESULTS Seven patients were excluded and 53/180 were lost to follow-up. In intention to treat analysis (n = 180), the SCG did not exhibit changes in any of the markers assessed. Post-intervention age-, sex-, baseline- and CPAP use-adjusted plasma high sensitivity C-reactive protein levels (mg/L) were lower in the MDG and the MLG compared to the SCG (mean difference - 1.33, P = 0.039 and - 1.68, P = 0.007, respectively). The MLG also exhibited lower urinary 8-iso prostaglandin F2a levels (ng/mg creatinine) compared to the SCG and the MDG (mean difference - 1.10, P < 0.0001 and - 0.80, P = 0.001, respectively). Adiponectin and oxidized guanine levels were not altered in any of the study groups. Results were similar in per protocol analysis (n = 127). CONCLUSION A weight-loss Mediterranean diet/lifestyle intervention on top of CPAP has anti-inflammatory and antioxidant benefits in OSA. REGISTRATION The trial was prospectively registered at ClinicalTrials.gov (NCT02515357) on August 4, 2015.",2021,"In intention to treat analysis (n = 180), the SCG did not exhibit changes in any of the markers assessed.","['Seven patients were excluded and 53/180 were lost to follow-up', 'patients with obstructive sleep apnea', 'obstructive sleep apnea (OSA) pathophysiology', '187 adult, overweight patients with moderate-to-severe OSA']","['OSA standard care', 'standard care (SCG, n\u2009=\u200965), a Mediterranean diet (MDG, n\u2009=\u200962) or a Mediterranean lifestyle group (MLG, n\u2009=\u200960', 'weight-loss Mediterranean diet/lifestyle intervention', 'weight-loss Mediterranean diet/lifestyle intervention with OSA standard care, i.e., continuous positive airway pressure (CPAP) prescription', 'behavioral weight-loss intervention based on the Mediterranean diet, while the MLG also received counselling on physical activity and sleep habits']","['urinary 8-iso prostaglandin F2a levels', 'Adiponectin and oxidized guanine levels', 'inflammation and oxidative stress']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0012694', 'cui_str': 'Cromolyn sodium'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0024443', 'cui_str': 'Madagascar'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0574375', 'cui_str': 'Malagasy language'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2133558', 'cui_str': 'Sleep Habits'}]","[{'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0012471', 'cui_str': 'Dinoprost'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0018321', 'cui_str': 'Guanine'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}]",187.0,0.169427,"In intention to treat analysis (n = 180), the SCG did not exhibit changes in any of the markers assessed.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Georgoulis', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University, 70 Eleftheriou Venizelou Str., 17671, Athens, Greece.'}, {'ForeName': 'Nikos', 'Initials': 'N', 'LastName': 'Yiannakouris', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University, 70 Eleftheriou Venizelou Str., 17671, Athens, Greece.'}, {'ForeName': 'Roxane', 'Initials': 'R', 'LastName': 'Tenta', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University, 70 Eleftheriou Venizelou Str., 17671, Athens, Greece.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Fragopoulou', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University, 70 Eleftheriou Venizelou Str., 17671, Athens, Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Kechribari', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University, 70 Eleftheriou Venizelou Str., 17671, Athens, Greece.'}, {'ForeName': 'Kallirroi', 'Initials': 'K', 'LastName': 'Lamprou', 'Affiliation': 'Center of Sleep Disorders, 1st Department of Critical Care and Pulmonary Services, Evangelismos Hospital, Medical School of Athens University, 45-47 Ipsilantou Str., 10676, Athens, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Perraki', 'Affiliation': 'Center of Sleep Disorders, 1st Department of Critical Care and Pulmonary Services, Evangelismos Hospital, Medical School of Athens University, 45-47 Ipsilantou Str., 10676, Athens, Greece.'}, {'ForeName': 'Emmanοuil', 'Initials': 'E', 'LastName': 'Vagiakis', 'Affiliation': 'Center of Sleep Disorders, 1st Department of Critical Care and Pulmonary Services, Evangelismos Hospital, Medical School of Athens University, 45-47 Ipsilantou Str., 10676, Athens, Greece.'}, {'ForeName': 'Meropi D', 'Initials': 'MD', 'LastName': 'Kontogianni', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University, 70 Eleftheriou Venizelou Str., 17671, Athens, Greece. mkont@hua.gr.'}]",European journal of nutrition,['10.1007/s00394-021-02552-w'] 3711,33839918,A randomized trial regarding antimicrobial prophylaxis (AMP) in transurethral resection of bladder tumor (TURB).,"PURPOSE To determine whether omitting antimicrobial prophylaxis (AMP) in TURB is safe in patients undergoing TURB without an indwelling pre-operative catheter/nephrostomy/DJ and a negative pre-operative urinary culture. MATERIALS AND METHODS A multi-centered randomized controlled trial (RCT) from 17-09-2017 to 31-12-2019 in 5 hospitals. Patients with a pre-operative indwelling catheter/DJ-stent or nephrostomy and a positive pre-operative urinary culture (> 10 4 uropathogens/mL) were excluded. Post-operative fever was defined as body temperature ≥ 38.3 °C. A non-inferiority design with a 6% noninferiority margin and null hypothesis (H0) that the infection risk is at least 6% higher in the experimental (E) than in the control (C) group; H0: C (AMP-group) - E (no AMP-group) ≥ Δ (6% noninferiority margin). A multivariable, logistic regression was performed for AMP and post-TURB fever with covariates: tumor size and (clot-) retention. The R Project ® for statistical computing was used for statistical analysis and a p value of 0.05 was considered as statistically significant. RESULTS 459 Patients were included and 202/459 (44.1%) received AMP vs 257/459 (55.9%) without AMP. Fever occurred in 6/202 [2.9%; 95% CI (1.2-6.6%)] patients with AMP vs 8/257 [3.1%; 95% CI (1.5%-6.1%)] without AMP (p = 0.44). Multivariable, logistic regression showed no significant harm in omitting AMP when controlled for (clot-)retention and tumor size (p = 0.85) and an adjusted risk difference in developing post-TURB fever of 0.0016; 95% CI [- 0.029; 0.032]. CONCLUSION Our data suggest the safety of omitting AMP in patients undergoing TURB without an indwelling, pre-operative catheter/nephrostomy/DJ and a negative pre-operative urinary culture.",2021,Fever occurred in 6/202 [2.9%; 95% CI (1.2-6.6%)] patients with AMP vs 8/257 [3.1%; 95% CI (1.5%-6.1%)] without AMP (p = 0.44).,"['Patients with a pre-operative indwelling catheter/DJ-stent or nephrostomy and a positive pre-operative urinary culture (>\u200910 4 uropathogens/mL) were excluded', 'patients undergoing TURB without an indwelling pre-operative catheter/nephrostomy/DJ and a negative pre-operative urinary culture', 'transurethral resection of bladder tumor (TURB', '17-09-2017 to 31-12-2019 in 5 hospitals', '459 Patients were included and 202/459 (44.1%) received']","['omitting antimicrobial prophylaxis (AMP', 'antimicrobial prophylaxis (AMP', 'AMP']","['omitting AMP', 'Fever']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0278314', 'cui_str': 'Nephrostomy'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0439848', 'cui_str': 'Indwelling'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0401496', 'cui_str': 'Transurethral resection of bladder neoplasm'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0015967', 'cui_str': 'Fever'}]",459.0,0.131699,Fever occurred in 6/202 [2.9%; 95% CI (1.2-6.6%)] patients with AMP vs 8/257 [3.1%; 95% CI (1.5%-6.1%)] without AMP (p = 0.44).,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Baten', 'Affiliation': 'Associatie Urologie Hageland, Kapellekensweg 10, Kessel-Lo, Belgium. Evert.baten@gmail.com.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Van der Aa', 'Affiliation': 'Department of Urology, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Goethuys', 'Affiliation': 'ZOL Genk, Genk, Belgium.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Slabbert', 'Affiliation': 'Associatie Urologie Hageland, Kapellekensweg 10, Kessel-Lo, Belgium.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Arijs', 'Affiliation': 'Center for Cancer Biology, VIB, 3000, Leuven, Belgium.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'van Renterghem', 'Affiliation': 'Department of Urology, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium.'}]",World journal of urology,['10.1007/s00345-021-03694-6'] 3712,33839890,Optimal definition of coagulation syndrome after colorectal endoscopic submucosal dissection: a post hoc analysis of randomized controlled trial.,"PURPOSE Endoscopic clipping closure after colorectal endoscopic submucosal dissection (ESD) did not reduce the incidence of post-ESD coagulation syndrome (PECS) in our recent randomized controlled trial (RCT); however, the definition of PECS is still controversial. The aim of this study is to establish optimal definition of PECS with additional analysis of RCT based on another definition. METHODS In this multicenter, single-blind RCT, individuals were randomly assigned to colorectal ESD followed by endoscopic clipping closure or non-closure. In this post hoc analysis, the definition of PECS was modified as both localized abdominal pain on visual analogue scale and inflammatory response (fever or leukocytosis), from either localized abdominal pain or inflammatory response in the original study. All participants underwent a computed tomography after ESD, and PECS was classified into type I, conventional PECS without extra-luminal air, and type II, PECS with peri-luminal air. RESULTS A total of 155 patients (84 in the non-closure group and 71 in the closure group) were analyzed. As a result of criteria modification, 21 type I PECS and four type II PECS cases in the original study, which included patients with clear pain and inflammatory response, were downgraded to no adverse event and simple peri-luminal air, respectively. The frequency of PECS showed no significant difference between non-closure and closure groups. CONCLUSION Clipping closure after colorectal ESD does not reduce the incidence of PECS regardless of the diagnostic criteria. Either localized abdominal pain or inflammatory response might be optimal criteria of PECS (UMIN000027031). TRIAL REGISTRATION NUMBER UMIN000027031 DATE OF REGISTRATION: April 18, 2017.",2021,"The frequency of PECS showed no significant difference between non-closure and closure groups. ","['155 patients (84 in the non-closure group and 71 in the closure group) were analyzed', 'All participants underwent a computed tomography after ESD, and PECS was classified into type']","['colorectal ESD followed by endoscopic clipping closure or non-closure', 'conventional PECS without extra-luminal air, and type II, PECS with peri-luminal air', 'colorectal endoscopic submucosal dissection', 'Endoscopic clipping closure after colorectal endoscopic submucosal dissection (ESD']","['visual analogue scale and inflammatory response (fever or leukocytosis', 'frequency of PECS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0347985', 'cui_str': 'During values'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0023518', 'cui_str': 'Leukocytosis'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]",155.0,0.0808826,"The frequency of PECS showed no significant difference between non-closure and closure groups. ","[{'ForeName': 'Takahito', 'Initials': 'T', 'LastName': 'Katano', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.'}, {'ForeName': 'Takaya', 'Initials': 'T', 'LastName': 'Shimura', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan. tshimura@med.nagoya-cu.ac.jp.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Nomura', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Iwai', 'Affiliation': 'Department of Gastroenterology, Toyokawa City Hospital, 23 Noji, Yahata, Toyokawa, 442-8561, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Mizuno', 'Affiliation': 'Department of Gastroenterology, Japanese Red Cross Nagoya Daini Hospital, 2-9 Myoken-cho, Showa-ku, Nagoya, 466-0814, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Department of Gastroenterology, Japanese Red Cross Nagoya Daini Hospital, 2-9 Myoken-cho, Showa-ku, Nagoya, 466-0814, Japan.'}, {'ForeName': 'Masahide', 'Initials': 'M', 'LastName': 'Ebi', 'Affiliation': 'Department of Gastroenterology, Aichi Medical University, 1-1 Karimata, Iwasaku, Nagakute, 480-1195, Japan.'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Hirata', 'Affiliation': 'Department of Gastroenterology, Kasugai Municipal Hospital, 1-1-1 Takaki, Kasugai, 486-0000, Japan.'}, {'ForeName': 'Hirotada', 'Initials': 'H', 'LastName': 'Nishie', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Mizushima', 'Affiliation': 'Department of Gastroenterology, Gifu Prefectural Tajimi Hospital, 5-161 Maehata, Tajimi, 507-8522, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Nojiri', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.'}, {'ForeName': 'Shozo', 'Initials': 'S', 'LastName': 'Togawa', 'Affiliation': 'Department of Gastroenterology, Nagoya Memorial Hospital, 4-305 Hirabari, Tenpaku-ku, Nagoya, 468-8520, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Koguchi', 'Affiliation': 'Department of Gastroenterology, Chukyo Hospital, 1-1-10 Sanjyo, Minami-ku, Nagoya, 457-8510, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Shibata', 'Affiliation': 'Department of Gastroenterology, Toyokawa City Hospital, 23 Noji, Yahata, Toyokawa, 442-8561, Japan.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Hayashi', 'Affiliation': 'Department of Gastroenterology, Kasugai Municipal Hospital, 1-1-1 Takaki, Kasugai, 486-0000, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Itoh', 'Affiliation': 'Department of Gastroenterology, Nagoya City East Medical Center, 1-2-23 Wakamizu, Chikusa-ku, Nagoya, 464-8547, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Kataoka', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.'}]",International journal of colorectal disease,['10.1007/s00384-021-03921-x'] 3713,33839885,"Incidence, predictors, and outcomes associated with acute kidney injury in patients undergoing transcatheter aortic valve replacement: from the BRAVO-3 randomized trial.","BACKGROUND Acute kidney injury (AKI) is not uncommon in patients undergoing transcatheter aortic valve replacement (TAVR). OBJECTIVE We examined the incidence, predictors, and outcomes of AKI from the BRAVO 3 randomized trial. METHODS The BRAVO-3 trial included 802 patients undergoing transfemoral TAVR randomized to bivalirudin vs. unfractionated heparin (UFH). The primary endpoint of the trial was Bleeding Academic Research Consortium (BARC) type ≥ 3b bleeding at 48 h. Total follow-up was to 30 days. AKI was adjudicated using the modified RIFLE (Valve Academic Research Consortium, VARC 1) criteria through 30-day follow-up, and in a sensitivity analysis AKI was assessed at 7 days (modified VARC-2 criteria). We examined the incidence, predictors, and 30-day outcomes associated with diagnosis of AKI. We also examined the effect of procedural anticoagulant (bivalirudin or unfractionated heparin, UFH) on AKI within 48 h after TAVR. RESULTS The trial population had a mean age of 82.3 ± 6.5 years including 48.8% women with mean EuroScore I 17.05 ± 10.3%. AKI occurred in 17.0% during 30-day follow-up and was associated with greater adjusted risk of 30-day death (13.0% vs. 3.5%, OR 5.84, 95% CI 2.62-12.99) and a trend for more BARC ≥ 3b bleeding (15.1% vs. 8.6%, OR 1.80, 95% CI 0.99-3.25). Predictors of 30-day AKI were baseline hemoglobin, body weight, and pre-existing coronary disease. AKI occurred in 10.7% at 7 days and was associated with significantly greater risk of 30-day death (OR 6.99, 95% CI 2.85-17.15). Independent predictors of AKI within 7 days included pre-existing coronary or cerebrovascular disease, chronic kidney disease (CKD), and transfusion which increased risk, whereas post-dilation was protective. The incidence of 48-h AKI was higher with bivalirudin compared to UFH in the intention to treat cohort (10.9% vs. 6.5%, p = 0.03), but not in the per-protocol assessment (10.7% vs. 7.1%, p = 0.08). CONCLUSION In the BRAVO 3 trial, AKI occurred in 17% at 30 days and in 10.7% at 7 days. AKI was associated with a significantly greater adjusted risk for 30-day death. Multivariate predictors of AKI at 30 days included baseline hemoglobin, body weight, and prior coronary artery disease, and predictors at 7 days included pre-existing vascular disease, CKD, transfusion, and valve post-dilation. Bivalirudin was associated with greater AKI within 48 h in the intention to treat but not in the per-protocol analysis.",2021,"The incidence of 48-h AKI was higher with bivalirudin compared to UFH in the intention to treat cohort (10.9% vs. 6.5%, p = 0.03), but not in the per-protocol assessment (10.7% vs. 7.1%, p = 0.08). ","['patients undergoing transcatheter aortic valve replacement', 'AKI within 48\xa0h\xa0after TAVR', '802 patients undergoing transfemoral TAVR randomized to', 'The trial population had a mean age of 82.3\u2009±\u20096.5\xa0years including 48.8% women with mean EuroScore I 17.05\u2009±\u200910.3', 'patients undergoing transcatheter aortic valve replacement (TAVR']","['procedural anticoagulant (bivalirudin or unfractionated heparin, UFH', 'bivalirudin vs. unfractionated heparin (UFH', 'Bivalirudin', 'bivalirudin']","['Bleeding Academic Research Consortium (BARC) type\u2009≥\u20093b bleeding at 48\xa0h', 'adjusted risk of 30-day death', '30-day death', 'pre-existing coronary or cerebrovascular disease, chronic kidney disease (CKD), and transfusion which increased risk', 'baseline hemoglobin, body weight, and prior coronary artery disease, and predictors at 7\xa0days included pre-existing vascular disease, CKD, transfusion, and valve post-dilation', '30-day AKI were baseline hemoglobin, body weight, and pre-existing coronary disease', 'AKI', 'risk of 30-day death', 'incidence of 48-h AKI', 'BARC\u2009≥\u20093b bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3164744', 'cui_str': 'European system for cardiac operative risk evaluation'}, {'cui': 'C4517519', 'cui_str': '10.3'}]","[{'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0168273', 'cui_str': 'bivalirudin'}, {'cui': 'C0019134', 'cui_str': 'heparin'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0007820', 'cui_str': 'Cerebrovascular disease'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042373', 'cui_str': 'Vascular disorder'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0010068', 'cui_str': 'Coronary Heart Disease'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",802.0,0.261658,"The incidence of 48-h AKI was higher with bivalirudin compared to UFH in the intention to treat cohort (10.9% vs. 6.5%, p = 0.03), but not in the per-protocol assessment (10.7% vs. 7.1%, p = 0.08). ","[{'ForeName': 'Jaya', 'Initials': 'J', 'LastName': 'Chandrasekhar', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Sartori', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, USA.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Aquino', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, USA.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Vogel', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, USA.'}, {'ForeName': 'Anita W', 'Initials': 'AW', 'LastName': 'Asgar', 'Affiliation': 'Institut de Cardiologie de Montreal, Montreal, Canada.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Webb', 'Affiliation': ""St. Paul's Hospital, Vancouver, Canada.""}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Tchetche', 'Affiliation': 'Clinic Pasteur of Toulouse, Toulouse, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Dumonteil', 'Affiliation': 'Clinic Pasteur of Toulouse, Toulouse, France.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Colombo', 'Affiliation': 'San Raffaele Hospital of Milan (IRCCS), Milan, Italy.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Bimmer E', 'Initials': 'BE', 'LastName': 'Claessen', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, USA.'}, {'ForeName': 'Jurriën M', 'Initials': 'JM', 'LastName': 'Ten Berg', 'Affiliation': 'St. Antonius Ziekenhuis, Nieuwegein, Netherlands.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hildick-Smith', 'Affiliation': 'Sussex Cardiac Centre, Brighton, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wijngaard', 'Affiliation': 'The Medicines Company, Zurich, Switzerland.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lefèvre', 'Affiliation': 'Hôpital Privé Jacques Cartier, Massy, France.'}, {'ForeName': 'Efthymios N', 'Initials': 'EN', 'LastName': 'Deliargyris', 'Affiliation': 'The Medicines Company, Parsippany, NJ, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hengstenberg', 'Affiliation': 'Munich Heart Alliance, Munich, Germany.'}, {'ForeName': 'Prodromos', 'Initials': 'P', 'LastName': 'Anthopoulos', 'Affiliation': 'The Medicines Company, Zurich, Switzerland.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Dangas', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, USA. gdangas@crf.org.'}]",Clinical research in cardiology : official journal of the German Cardiac Society,['10.1007/s00392-020-01787-7'] 3714,33839835,An Update on the COGiTATE Phase II Study: Feasibility and Safety of Targeting an Optimal Cerebral Perfusion Pressure as a Patient-Tailored Therapy in Severe Traumatic Brain Injury.,"INTRODUCTION Monitoring of cerebral autoregulation (CA) in patients with a traumatic brain injury (TBI) can provide an individual 'optimal' cerebral perfusion pressure (CPP) target (CPPopt) at which CA is best preserved. This potentially offers an individualized precision medicine approach. Retrospective data suggest that deviation of CPP from CPPopt is associated with poor outcomes. We are prospectively assessing the feasibility and safety of this approach in the COGiTATE [CPPopt Guided Therapy: Assessment of Target Effectiveness] study. Its primary objective is to demonstrate the feasibility of individualizing CPP at CPPopt in TBI patients. The secondary objectives are to investigate the safety and physiological effects of this strategy. METHODS The COGiTATE study has included patients in four European hospitals in Cambridge, Leuven, Nijmegen, and Maastricht (coordinating centre). Patients with severe TBI requiring intracranial pressure (ICP)-directed therapy are allocated into one of two groups. In the intervention group, CPPopt is calculated using a published (modified) algorithm. In the control group, the CPP target recommended in the Brain Trauma Foundation guidelines (CPP 60-70 mmHg) is used. RESULTS Patient recruitment started in February 2018 and will continue until 60 patients have been studied. Fifty-one patients (85% of the intended total) have been recruited in October 2019. The first results are expected early 2021. CONCLUSION This prospective evaluation of the feasibility, safety and physiological implications of autoregulation-guided CPP management is providing evidence that will be useful in the design of a future phase III study in severe TBI patients.",2021,"In the control group, the CPP target recommended in the Brain Trauma Foundation guidelines (CPP 60-70 mmHg) is used. ","['patients with a traumatic brain injury (TBI', 'The COGiTATE\xa0study has included patients in four European\xa0hospitals in Cambridge, Leuven, Nijmegen, and Maastricht (coordinating centre', 'Fifty-one patients (85% of the intended total) have been recruited in October 2019', 'Patients with severe TBI requiring intracranial pressure (ICP)-directed therapy', 'severe TBI patients', 'Severe Traumatic Brain Injury', 'TBI patients']","['COGiTATE', 'cerebral autoregulation (CA']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0021880', 'cui_str': 'Intracranial pressure'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}]",[],51.0,0.0253684,"In the control group, the CPP target recommended in the Brain Trauma Foundation guidelines (CPP 60-70 mmHg) is used. ","[{'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Tas', 'Affiliation': 'Department of Intensive Care Medicine, University of Maastricht, Maastricht University Medical Centre, Maastricht, The Netherlands. Jeanette.tas@mumc.nl.'}, {'ForeName': 'Erta', 'Initials': 'E', 'LastName': 'Beqiri', 'Affiliation': 'Brain Physics Laboratory, Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'van Kaam', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Ercole', 'Affiliation': ""University Division of Anaesthesia, University of Cambridge, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Bellen', 'Affiliation': 'Department of Neurosciences, Catholic University Leuven, University Hospital Leuven, Leuven, Belgium.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Bruyninckx', 'Affiliation': 'Department of Neurosciences, Catholic University Leuven, University Hospital Leuven, Leuven, Belgium.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Cabeleira', 'Affiliation': 'Brain Physics Laboratory, Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Czosnyka', 'Affiliation': 'Brain Physics Laboratory, Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Depreitere', 'Affiliation': 'Department of Neurosciences, Catholic University Leuven, University Hospital Leuven, Leuven, Belgium.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Donnelly', 'Affiliation': 'Brain Physics Laboratory, Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Fedriga', 'Affiliation': 'Brain Physics Laboratory, Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Hutchinson', 'Affiliation': 'Department of Clinical Neurosciences, Cambridge University, Cambridge, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Menon', 'Affiliation': ""University Division of Anaesthesia, University of Cambridge, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Meyfroidt', 'Affiliation': 'Department of Cellular and Molecular Medicine, Catholic University Leuven, University Hospital, Leuven, Belgium.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Liberti', 'Affiliation': 'Department of Intensive Care Medicine, University of Maastricht, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Outtrim', 'Affiliation': ""University Division of Anaesthesia, University of Cambridge, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Robba', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Policlinico San Martino, IRCCS for Oncology and Neuroscience, Genoa, Italy.'}, {'ForeName': 'C W E', 'Initials': 'CWE', 'LastName': 'Hoedemaekers', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Smielewski', 'Affiliation': 'Brain Physics Laboratory, Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Marcel J', 'Initials': 'MJ', 'LastName': 'Aries', 'Affiliation': 'Department of Intensive Care Medicine, University of Maastricht, Maastricht University Medical Centre, Maastricht, The Netherlands.'}]",Acta neurochirurgica. Supplement,['10.1007/978-3-030-59436-7_29'] 3715,33839803,No difference of gait parameters in patients with image-free robotic-assisted medial unicompartmental knee arthroplasty compared to a conventional technique: early results of a randomized controlled trial.,"PURPOSE In recent studies, robotic-assisted surgical techniques for unicompartmental knee arthroplasty (UKA) have demonstrated superior implant positioning and limb alignment compared to a conventional technique. However, the impact of the robotic-assisted technique on clinical and functional outcomes is less clear. The aim of this study was to compare the gait parameters of UKA performed with conventional and image-free robotic-assisted techniques. METHODS This prospective, single-center study included 66 medial UKA, randomized to a robotic-assisted (n = 33) or conventional technique (n = 33). Gait knee kinematics was assessed on a treadmill at 6 months to identify changes in gait characteristics (walking speed, each degree-of-freedom: flexion-extension, abduction-adduction, internal-external rotation, and anterior-posterior displacement). Clinical results were assessed at 6 months using the IKS score and the Forgotten Joint Score. Implants position was assessed on post-operative radiographs. RESULTS Post-operatively, the whole gait cycle was not significantly different between groups. In both groups, there was a significant improvement in varus deformity between the pre- and post-operative gait cycle. There was no significant difference between the two groups in clinical scores, implant position, revision, and complication rates. CONCLUSION No difference of gait parameters could be identified between medial UKA performed with image-free robotic-assisted technique or with conventional technique. LEVEL OF EVIDENCE Prospective randomized controlled trial. Level of evidence I.",2021,"In both groups, there was a significant improvement in varus deformity between the pre- and post-operative gait cycle.","['patients with image-free', 'unicompartmental knee arthroplasty (UKA', '66 medial UKA']","['robotic-assisted technique', 'robotic-assisted medial unicompartmental knee arthroplasty', 'robotic-assisted surgical techniques', 'robotic-assisted (n\u2009=\u200933) or conventional technique', 'conventional technique', 'conventional and image-free robotic-assisted techniques']","['Gait knee kinematics', 'gait parameters', 'gait characteristics (walking speed, each degree-of-freedom: flexion-extension, abduction-adduction, internal-external rotation, and anterior-posterior displacement', 'IKS score and the Forgotten Joint Score', 'varus deformity', 'clinical scores, implant position, revision, and complication rates', 'whole gait cycle']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0864243', 'cui_str': 'Unicompartmental Knee Arthroplasty'}, {'cui': 'C0205098', 'cui_str': 'Medial'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0864243', 'cui_str': 'Unicompartmental Knee Arthroplasty'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0444509', 'cui_str': 'Flexion/extension'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0231457', 'cui_str': 'Adduction'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0333044', 'cui_str': 'Posterior displacement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4759288', 'cui_str': 'Forgotten Joint Score'}, {'cui': 'C0432593', 'cui_str': 'Varus angulation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",66.0,0.0418203,"In both groups, there was a significant improvement in varus deformity between the pre- and post-operative gait cycle.","[{'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Batailler', 'Affiliation': 'Orthopaedics Surgery and Sports Medicine Department, Croix-Rousse Hospital, Lyon University Hospital, Lyon, France. cecile-batailler@hotmail.fr.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Lording', 'Affiliation': 'Melbourne Orthopaedic Group, Windsor, Australia.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Naaim', 'Affiliation': 'Claude Bernard Lyon 1 University, IFSTTAR, LBMC UMR_T9406, F69622, Univ Lyon, Lyon, France.'}, {'ForeName': 'Elvire', 'Initials': 'E', 'LastName': 'Servien', 'Affiliation': 'Orthopaedics Surgery and Sports Medicine Department, Croix-Rousse Hospital, Lyon University Hospital, Lyon, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Cheze', 'Affiliation': 'Claude Bernard Lyon 1 University, IFSTTAR, LBMC UMR_T9406, F69622, Univ Lyon, Lyon, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Lustig', 'Affiliation': 'Orthopaedics Surgery and Sports Medicine Department, Croix-Rousse Hospital, Lyon University Hospital, Lyon, France.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-021-06560-5'] 3716,33839788,"Effect of Aerobic or Resistance Exercise, or Both, on Intermuscular and Visceral Fat and Physical and Metabolic Function in Older Adults with Obesity While Dieting.","BACKGROUND Obesity exacerbates age-related effects on body composition, physical and metabolic function. Which exercise mode is most effective in mitigating these deleterious changes in dieting obese older adults is unknown. METHODS In a randomized controlled trial, we performed a head-to-head comparison of aerobic (AEX), resistance (REX), or combination (COMB) exercise during matched weight loss in 160 obese older adults. Prespecified analyses compared 6-month changes in intermuscular adipose tissue (IMAT) and visceral adipose tissue (VAT) assessed using MRI, insulin sensitivity index (ISI) by oral glucose tolerance test, physical function using Modified Physical Performance Test (PPT), VO2peak, gait-speed, and knee strength by dynamometry. RESULTS IMAT and VAT decreased more in COMB than AEX and REX groups (IMAT; -41% vs. -28% and -23% and VAT: -36% vs. -19% and -21%; p=.003 to .01); IMAT and VAT decreased in all groups more than control (CON) (between-group p<.001). ISI increased more in COMB than AEX and REX groups (86% vs. 50% and 39%; p=.005 to .03). PPT improved more in COMB than AEX and REX groups, while VO2peak improved more in COMB and AEX than REX group (all p<.05). Knee strength improved more in COMB and REX than AEX group (all p<.05). Changes in IMAT and VAT correlated with PPT (r=-.28 and -.39), VO2peak (r=-.49 and -.52), gait-speed (r=-.25 and -.36), and ISI (r=-.49 and -.52) (all p<.05). CONCLUSIONS Weight loss plus combination aerobic and resistance exercise was most effective in improving ectopic fat deposition and physical and metabolic function in older adults with obesity.",2021,Knee strength improved more in COMB and REX than AEX group (all p<.05).,"['Older Adults with Obesity While Dieting', 'dieting obese older adults', 'older adults with obesity', '160 obese older adults']","['AEX', 'Weight loss plus combination aerobic and resistance exercise', 'VAT', 'REX', 'Aerobic or Resistance Exercise', 'head-to-head comparison of aerobic (AEX), resistance (REX), or combination (COMB) exercise']","['ectopic fat deposition and physical and metabolic function', 'ISI', 'Changes in IMAT and VAT', 'gait-speed', 'intermuscular adipose tissue (IMAT) and visceral adipose tissue (VAT) assessed using MRI, insulin sensitivity index (ISI) by oral glucose tolerance test, physical function using Modified Physical Performance Test (PPT), VO2peak, gait-speed, and knee strength by dynamometry', 'Intermuscular and Visceral Fat and Physical and Metabolic Function', 'IMAT and VAT decreased more in COMB', 'IMAT and VAT', 'PPT improved more in COMB', 'Knee strength']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0324505', 'cui_str': 'Rex cat breed'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}]","[{'cui': 'C0340464', 'cui_str': 'Ectopic beats'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",160.0,0.0160554,Knee strength improved more in COMB and REX than AEX group (all p<.05).,"[{'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Waters', 'Affiliation': 'Department of Internal Medicine, School of Medicine, University of New Mexico, Albuquerque, New Mexico.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Aguirre', 'Affiliation': 'Department of Internal Medicine, School of Medicine, University of New Mexico, Albuquerque, New Mexico.'}, {'ForeName': 'A Burke', 'Initials': 'AB', 'LastName': 'Gurney', 'Affiliation': 'Division of Physical Therapy, School of Medicine, University of New Mexico, Albuquerque, New Mexico.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Sinacore', 'Affiliation': 'Department of Physical Therapy, High Point University, High Point, North Carolina and Program in Physical Therapy, Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Fowler', 'Affiliation': 'New Mexico Veterans Affairs Health Care System, Albuquerque, New Mexico.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Gregori', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Reina', 'Initials': 'R', 'LastName': 'Armamento-Villareal', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Clifford', 'Initials': 'C', 'LastName': 'Qualls', 'Affiliation': 'Department of Mathematics and Statistics, School of Medicine, University of New Mexico, Albuquerque, New Mexico.'}, {'ForeName': 'Dennis T', 'Initials': 'DT', 'LastName': 'Villareal', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, Baylor College of Medicine, Houston, Texas.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glab111'] 3717,33839787,Preoperative amlodipine is efficacious in preventing intraoperative HDI in pheochromocytoma- pilot RCT.,"BACKGROUND Preoperative blockade with α-blockers is recommended in patients with pheochromocytoma/paraganglioma (PPGL). The data on calcium channel blockade (CCB) in PPGL is scarce. We aimed to compare the efficacy of CCB and α-blockers on intraoperative haemodynamic instability (HDI) in PPGL. METHODS In the interim analysis of this monocentric, pilot, open-label, randomized controlled trial, patients with solitary, secretory, and nonmetastatic PPGL were randomized to oral prazosin GITS (maximum 30mg, n=9) or amlodipine (maximum 20mg, n=11). The primary outcomes were the episodes and duration of hypertension (SBP≥160mmHg) and hypotension (MAP<60mmHg) and duration of HDI (hypertension and/or hypotension) as a percentage of total surgical time (from induction of anaesthesia to skin closure). FINDINGS The median (IQR) episodes (2 [1-3] vs. 0 [0-1], p 0·002) and duration of hypertension (19 [14-42] min vs. 0 [0-3] min, p 0·001) and intraoperative HDI duration (22·85±18.4% vs 2·44±2·4%, CI 8·68-32·14%, p 0·002) were significantly higher in the prazosin GITS arm than the amlodipine arm whereas episodes and duration of hypotension did not differ between the two groups. There was no perioperative mortality whereas one patient had intraoperative ST depression on the electrocardiogram. The drug-related adverse effects were pedal edema (1 in amlodipine), dizziness (1 in prazosin GITS), and tachycardia (6 in prazosin GITS and 3 in amlodipine). INTERPRETATION Preoperative blockade with amlodipine is an efficacious alternative to prazosin GITS in preventing intraoperative HDI in PPGL. Larger studies that compare preoperative blockade by amlodipine with other α-blockers like phenoxybenzamine and/or doxazosin in PPGL patients are warranted.",2021,"INTERPRETATION Preoperative blockade with amlodipine is an efficacious alternative to prazosin GITS in preventing intraoperative HDI in PPGL.","['patients with pheochromocytoma/paraganglioma (PPGL', 'patients with solitary, secretory, and nonmetastatic PPGL']","['doxazosin', 'Preoperative amlodipine', 'CCB and α-blockers', 'amlodipine', 'oral prazosin GITS (maximum 30mg, n=9) or amlodipine']","['intraoperative HDI duration', 'episodes and duration of hypertension (SBP≥160mmHg) and hypotension (MAP<60mmHg) and duration of HDI (hypertension and/or hypotension) as a percentage of total surgical time (from induction of anaesthesia to skin closure', 'intraoperative haemodynamic instability (HDI', 'median (IQR) episodes', 'intraoperative ST depression', 'dizziness (1 in prazosin GITS), and tachycardia', 'duration of hypertension', 'perioperative mortality', 'episodes and duration of hypotension']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031511', 'cui_str': 'Chromaffinoma'}, {'cui': 'C0030421', 'cui_str': 'Paraganglioma'}, {'cui': 'C0205171', 'cui_str': 'Singular'}]","[{'cui': 'C0114873', 'cui_str': 'Doxazosin'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0006685', 'cui_str': 'Calcium Channel'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032912', 'cui_str': 'Prazosin'}, {'cui': 'C0806909', 'cui_str': 'Max'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0948268', 'cui_str': 'Hemodynamic instability'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0520887', 'cui_str': 'ST segment depression'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0032912', 'cui_str': 'Prazosin'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.108302,"INTERPRETATION Preoperative blockade with amlodipine is an efficacious alternative to prazosin GITS in preventing intraoperative HDI in PPGL.","[{'ForeName': 'Sanjeet Kumar', 'Initials': 'SK', 'LastName': 'Jaiswal', 'Affiliation': 'Department of Endocrinology, Seth G S Medical College and KEM Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Saba Samad', 'Initials': 'SS', 'LastName': 'Memon', 'Affiliation': 'Department of Endocrinology, Seth G S Medical College and KEM Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Anurag', 'Initials': 'A', 'LastName': 'Lila', 'Affiliation': 'Department of Endocrinology, Seth G S Medical College and KEM Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Vijaya', 'Initials': 'V', 'LastName': 'Sarathi', 'Affiliation': 'Department of Endocrinology, Vydehi Institute of Medical Sciences and Research Centre, Bangalore, India.'}, {'ForeName': 'Manjunath', 'Initials': 'M', 'LastName': 'Goroshi', 'Affiliation': 'Jawaharlal Nehru Medical College, Belagavi, India.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Garg', 'Affiliation': 'Department of Endocrinology, Seth G S Medical College and KEM Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Barnabas', 'Affiliation': 'Department of Endocrinology, Seth G S Medical College and KEM Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Indrani', 'Initials': 'I', 'LastName': 'Hemantkumar', 'Affiliation': 'Department of Anaesthesia, Seth G S Medical College and KEM Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Rajendra D', 'Initials': 'RD', 'LastName': 'Patel', 'Affiliation': 'Department of Anaesthesia, Seth G S Medical College and KEM Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Shrikanta', 'Initials': 'S', 'LastName': 'Oak', 'Affiliation': 'Department of Anaesthesia, Seth G S Medical College and KEM Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Abhay', 'Initials': 'A', 'LastName': 'Dalvi', 'Affiliation': 'Department of Surgery, Seth G S Medical College and KEM Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Mahadeo', 'Initials': 'M', 'LastName': 'Garale', 'Affiliation': 'Department of Surgery, Seth G S Medical College and KEM Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Virendra', 'Initials': 'V', 'LastName': 'Patil', 'Affiliation': 'Department of Endocrinology, Seth G S Medical College and KEM Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Nalini S', 'Initials': 'NS', 'LastName': 'Shah', 'Affiliation': 'Department of Endocrinology, Seth G S Medical College and KEM Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Tushar', 'Initials': 'T', 'LastName': 'Bandgar', 'Affiliation': 'Department of Endocrinology, Seth G S Medical College and KEM Hospital, Mumbai, Maharashtra, India.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgab231'] 3718,33839775,Intensive and App-Delivered Occupational Therapy to Improve Upper Extremity Function in Early Diffuse Cutaneous Systemic Sclerosis: A Pilot Two-Arm Trial.,"OBJECTIVE Systemic sclerosis (SSc) reduces upper extremity function and performance of everyday activities; however, there are few evidence-based rehabilitation interventions. This study examined short and longer-term effects of two occupational therapy interventions on hand disability. METHODS Participants with diffuse cutaneous SSc were randomized to one of two 18-week interventions: Intensive group, receiving 8-weekly in-person occupational therapy sessions with App-delivered home exercises, or App alone group. The primary outcome was QuickDASH hand disability; secondary outcomes were physical function (PROMIS scale), and total active hand motion. Linear mixed models were used to examine treatment effects. RESULTS Most participants were female (72%); the mean age was 52 years ± 13.4 (n = 32). There were no significant between-group effects on QuickDASH (p = 1.0; mean change -6.4 on 0-100 scale in both groups at 18 weeks). Left lateral pinch, an exploratory outcome, improved in App alone compared to Intensive from baseline to 18 weeks. Within groups, the intensive group had the largest improvements after 8 weeks (-8.5 on QuickDASH; p = 0.03), but then lost gains from 8 to 18 weeks while the App alone group had modest improvements from baseline to 8 weeks, but then continued to improve. Of completers, 50% had clinically meaningful improvement on QuickDASH in the Intensive group and 64% had improvement in App alone. CONCLUSION Both interventions showed beneficial effects on hand disability. Participants in the App alone group improved equally to the Intensive group at 18 weeks. Our findings provide support for further study into telehealth rehabilitation approaches.",2021,There were no significant between-group effects on QuickDASH (p = 1.0; mean change -6.4 on 0-100 scale in both groups at 18 weeks).,"['Early Diffuse Cutaneous Systemic Sclerosis', 'Participants with diffuse cutaneous SSc', 'Most participants were female (72%); the mean age was 52 years ± 13.4 (n\u2009=\u200932']","['Intensive group, receiving 8-weekly in-person occupational therapy sessions with App-delivered home exercises, or App alone group', 'Intensive and App-Delivered Occupational Therapy', 'occupational therapy interventions']","['QuickDASH hand disability; secondary outcomes were physical function (PROMIS scale), and total active hand motion', 'QuickDASH', 'beneficial effects on hand disability']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1258104', 'cui_str': 'Progressive systemic sclerosis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517558', 'cui_str': '13.4'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0414858,There were no significant between-group effects on QuickDASH (p = 1.0; mean change -6.4 on 0-100 scale in both groups at 18 weeks).,"[{'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Murphy', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, University of Michigan, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Barber', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, University of Michigan, USA.'}, {'ForeName': 'Suiyuan', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Division of Rheumatology, University of Michigan, Ann Arbor, MI USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Sabbagh', 'Affiliation': 'School of Public Health, University of Michigan, Ann Arbor, MI USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Cutter', 'Affiliation': 'School of Public Health, University of Alabama at Birmingham, AL, USA.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Khanna', 'Affiliation': 'Division of Rheumatology, University of Michigan, Ann Arbor, MI USA.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keab339'] 3719,33839766,The effect of a consumer-based activity tracker intervention on accelerometer-measured sedentary time among retirees: a randomized controlled REACT trial.,"BACKGROUND Effective strategies to reverse the increasing trend of sedentary behavior after retirement are needed. The aim of this study was to examine the effect of 12-month activity tracker-based intervention on daily total and prolonged sedentary time (≥60 min) among recent retirees. METHODS Randomization to intervention and control groups was performed to 231 retirees (mean age 65.2 (SD 1.1) years, 83% women). Intervention participants wore a consumer-based wrist-worn activity tracker (Polar Loop 2, Polar, Kempele, Finland), including daily activity goal, every day and night for 12 months. The activity tracker also gave vibrating reminders to break up uninterrupted inactivity periods after 55 minutes. A wrist-worn triaxial ActiGraph wGT3X-BT accelerometer was used to measure sedentary time at baseline and at 3-, 6- and 12-month time points. RESULTS The use of an activity tracker did not reduce daily total or prolonged sedentary time over 12 months (p values for time*group interaction 0.27 and 0.39, respectively). In the post-hoc analysis focusing on short- and medium-term effects on prolonged sedentary time, no differences between the intervention and control groups over three months were found, but a tendency for a greater decrease in prolonged sedentary time in the intervention group over six months was seen (mean difference in changes between the groups 29 min, 95% CI -2 to 61). CONCLUSIONS The activity tracker with inactivity alerts did not elicit changes in sedentary time over 12 months among recent retirees. Alternative approaches may be needed to achieve long-term changes in sedentary time among retirees.",2021,"The use of an activity tracker did not reduce daily total or prolonged sedentary time over 12 months (p values for time*group interaction 0.27 and 0.39, respectively).","['231 retirees (mean age 65.2 (SD 1.1) years, 83% women', 'accelerometer-measured sedentary time among retirees']","['consumer-based activity tracker intervention', 'consumer-based wrist-worn activity tracker (Polar Loop 2, Polar, Kempele, Finland', 'activity tracker-based intervention']","['prolonged sedentary time', 'daily total and prolonged sedentary time', 'daily total or prolonged sedentary time']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0016132', 'cui_str': 'Finland'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.0598862,"The use of an activity tracker did not reduce daily total or prolonged sedentary time over 12 months (p values for time*group interaction 0.27 and 0.39, respectively).","[{'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Suorsa', 'Affiliation': 'Department of Public Health, University of Turku and Turku University Hospital, Finland.'}, {'ForeName': 'Tuija', 'Initials': 'T', 'LastName': 'Leskinen', 'Affiliation': 'Department of Public Health, University of Turku and Turku University Hospital, Finland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Pulakka', 'Affiliation': 'Finnish Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Jaana', 'Initials': 'J', 'LastName': 'Pentti', 'Affiliation': 'Clinicum, Faculty of Medicine, University of Helsinki, Finland.'}, {'ForeName': 'Eliisa', 'Initials': 'E', 'LastName': 'Löyttyniemi', 'Affiliation': 'Department of Biostatistics, University of Turku and Turku University Hospital, Finland.'}, {'ForeName': 'Ilkka', 'Initials': 'I', 'LastName': 'Heinonen', 'Affiliation': 'Turku PET Centre, and department of Clinical Physiology and Nuclear Medicine, University of Turku, Turku, Finland.'}, {'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Vahtera', 'Affiliation': 'Department of Public Health, University of Turku and Turku University Hospital, Finland.'}, {'ForeName': 'Sari', 'Initials': 'S', 'LastName': 'Stenholm', 'Affiliation': 'Department of Public Health, University of Turku and Turku University Hospital, Finland.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glab107'] 3720,33839753,Mechanical and oral antibiotic bowel preparation versus no bowel preparation in right and left colectomy: subgroup analysis of MOBILE trial.,"BACKGROUND In retrospective series, mechanical and oral antibiotic bowel preparation (MOABP) has been reported to reduce surgical-site infections (SSIs) after colectomy compared with no bowel preparation (NBP). METHOD This was a subgroup analysis of a multicentre randomized trial that included patients scheduled for elective colectomy. The MOABP group underwent mechanical bowel preparation, and took 2 g neomycin and 2 g metronidazole orally during the day before surgery. The NBP group did not undergo bowel preparation. Patients were categorized according to the side of resection (right versus left colectomy), and these subgroups compared for postoperative outcomes. RESULTS Among 217 patients undergoing right colectomy (106 in MOABP and 111 in NBP group), SSI was detected in seven (7 per cent) and 10 (9 per cent) patients (odds ratio (OR) 0.71, 95 per cent c.i. 0.26 to 1.95; P = 0.510), anastomotic dehiscence in two (2 per cent) and two (2 per cent) patients (OR 1.05, 0.15 to 7.58; P = 1.000), and the mean(s.d.) Comprehensive Complication Index (CCI) score was 9.4(12.9) and 10.5(18.0) (mean difference -1.09; 95 per cent c.i. -5.29 to 3.11; P = 0.608) in the MOABP and NBP groups respectively. Among 164 patients undergoing left colectomy (84 in MOABP and 80 in NBP group), SSI was detected in five (6 per cent) and eight (10 per cent) patients (OR 0.57, 0.18 to 1.82; P = 0.338), anastomotic dehiscence in four (5 per cent) and five (6 per cent) patients (OR 0.75, 0.19 to 2.90; P = 0.742), and the CCI score was 10.2(13.1) and 6.5(11.0) (mean difference 3.68, -0.06 to 7.42; P = 0.053) in the MOABP and NBP groups respectively. CONCLUSIONS MOABP did not decrease the rate of SSI or complications in patients undergoing either right or left colectomy compared with NBP.",2021,"CONCLUSIONS MOABP did not decrease the rate of SSI or complications in patients undergoing either right or left colectomy compared with NBP.","['164 patients undergoing left colectomy (84 in MOABP and 80 in NBP group', 'right and left colectomy', 'patients scheduled for elective colectomy', '217 patients undergoing right colectomy (106 in MOABP and 111 in NBP group']","['MOABP', 'NBP', 'mechanical and oral antibiotic bowel preparation (MOABP', 'metronidazole', 'Mechanical and oral antibiotic bowel preparation versus no bowel preparation']","['rate of SSI or complications', 'anastomotic dehiscence', 'Comprehensive Complication Index (CCI) score', 'SSI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0009274', 'cui_str': 'Excision of colon'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0192861', 'cui_str': 'Right colectomy'}, {'cui': 'C0303403', 'cui_str': 'Indium-111'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0677554', 'cui_str': 'Anastomosis - action'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",217.0,0.288405,"CONCLUSIONS MOABP did not decrease the rate of SSI or complications in patients undergoing either right or left colectomy compared with NBP.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Koskenvuo', 'Affiliation': 'Department of Gastroenterological Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Lehtonen', 'Affiliation': 'Department of Gastroenterological Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Koskensalo', 'Affiliation': 'Department of Gastroenterological Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rasilainen', 'Affiliation': 'Department of Gastroenterological Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Klintrup', 'Affiliation': 'Department of Surgery, Surgical Research Unit, Medical Research Centre, Oulu University Hospital, University of Oulu, Oulu, Finland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ehrlich', 'Affiliation': 'Department of Surgery, Central Hospital of Central Finland, Jyväskylä, Finland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Pinta', 'Affiliation': 'Department of Surgery, Seinäjoki Central Hospital, Seinäjoki, Finland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Scheinin', 'Affiliation': 'Department of Gastroenterological Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Sallinen', 'Affiliation': 'Department of Gastroenterological Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}]",BJS open,['10.1093/bjsopen/zrab011'] 3721,33839731,Rest or 30-Min Walk as Exercise Intervention (RESTOREX) in Myasthenia Gravis: A Randomized Controlled Trial.,"INTRODUCTION There is a lack of evidence about the usefulness of exercise or rest in myasthenia gravis (MG). This study is aimed to evaluate the efficacy and safety of exercise or rest in MG. METHODS In a single-center open-labeled randomized controlled trial, the patients with mild to moderate MG were randomized to 30-min walk or rest in addition to the standard treatment. The primary endpoint was 50% improvement in the MG Quality of Life (MG-QOL15), and secondary endpoints were change in the Myasthenic Muscle Score (MMS), MG Activities of Daily Living (MGADL), grip strength, dose of acetylcholine esterase inhibitor and prednisone, 6-min walk test (6MWT), decrement in trapezius on the low-rate repetitive nerve stimulation test, and adverse events. The outcomes were defined at 3 months, by >50% improvement in these outcome parameters. RESULTS Forty patients with MG were randomized to the exercise or rest arm. The 2 arms were matched for demographic and clinical parameters. The patients in the exercise arm had significantly better QOL evidenced by MG-QOL15 (p = 0.02). The secondary endpoints, distance covered in 6MWT (p = 0.007), were also better in the exercise arm without any adverse event. CONCLUSION Regular exercise for 30 min in mild and moderate MG improves quality of life and walking distance compared to rest and is safe. CLINICAL TRIAL REGISTRATION The clinical trial registration number is CTRI/2019/11/021869.",2021,The patients in the exercise arm had significantly better QOL evidenced by MG-QOL15 (p = 0.02).,"['Myasthenia Gravis', 'Forty patients with MG', 'patients with mild to moderate MG']","['Regular exercise', 'Rest or 30-Min Walk as Exercise Intervention']","['Myasthenic Muscle Score (MMS), MG Activities of Daily Living (MGADL), grip strength, dose of acetylcholine esterase inhibitor and prednisone, 6-min walk test (6MWT), decrement in trapezius on the low-rate repetitive nerve stimulation test, and adverse events', 'distance covered in 6MWT', 'MG Quality of Life (MG-QOL15', 'quality of life and walking distance', 'QOL']","[{'cui': 'C0026896', 'cui_str': 'Myasthenia gravis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0582191', 'cui_str': 'Regular exercise'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia gravis'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0001044', 'cui_str': 'Acetylcholinesterase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0430810', 'cui_str': 'Repetitive nerve stimulation'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",40.0,0.114828,The patients in the exercise arm had significantly better QOL evidenced by MG-QOL15 (p = 0.02).,"[{'ForeName': 'Usha K', 'Initials': 'UK', 'LastName': 'Misra', 'Affiliation': 'Department of Neurology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, India.'}, {'ForeName': 'Jayantee', 'Initials': 'J', 'LastName': 'Kalita', 'Affiliation': 'Department of Neurology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, India.'}, {'ForeName': 'Varun K', 'Initials': 'VK', 'LastName': 'Singh', 'Affiliation': 'Department of Neurology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.'}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Kapoor', 'Affiliation': 'Department of Cardiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, India.'}, {'ForeName': 'Abhilasha', 'Initials': 'A', 'LastName': 'Tripathi', 'Affiliation': 'Department of Neurology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, India.'}, {'ForeName': 'Prabhakar', 'Initials': 'P', 'LastName': 'Mishra', 'Affiliation': 'Department of Biostatistics, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, India.'}]",European neurology,['10.1159/000513668'] 3722,33839619,The influence of nocebo information on fatigue and urge to stop: An experimental investigation.,"BACKGROUND AND OBJECTIVES Fatigue is an adaptive state after prolonged effort and often goes hand in hand with changes in behavior and motivation, such as the urge to stop exerting further effort. However, fatigue may become chronic in nature, as seen in multiple psychiatric disorders and chronic diseases, thereby losing its adaptive function. The etiology of fatigue symptoms remains poorly understood. We aimed to investigate whether nocebo information about the fatigue inducing nature of a cognitive task may contribute to the experience of fatigue and the motivational urge to stop. METHODS Participants (N = 46) repeatedly rated currently experienced fatigue while engaging in cognitive effort (working memory task). Crucially, half of participants received nocebo instructions prior to this task, whereas the other half only received neutral information. RESULTS Over the entire sample, results showed an increase in fatigue and urge to stop as the task progressed. Crucially, participants in the nocebo condition reported a higher urge to stop throughout the task relative to participants in the neutral condition. No significant effects were found for fatigue. Interestingly however, after controlling for baseline differences between conditions in negative affect, there was a significant Condition*Task block interaction effect on fatigue. LIMITATIONS Limitations include the relatively short experimental protocol and the underrepresentation of male relative to female participants. CONCLUSIONS These findings suggest that heightened awareness among clinicians and therapists about potential nocebo effects in their communication is warranted.",2021,No significant effects were found for fatigue.,"['Participants (N\xa0=\xa046', 'male relative to female participants']","['nocebo instructions', 'nocebo information', 'repeatedly rated currently experienced fatigue while engaging in cognitive effort (working memory task']","['fatigue and urge to stop as the task progressed', 'fatigue and urge to stop', 'fatigue']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]",46.0,0.181908,No significant effects were found for fatigue.,"[{'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Lenaert', 'Affiliation': 'School for Mental Health and Neuroscience, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands; Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, the Netherlands; Limburg Brain Injury Centre, the Netherlands. Electronic address: bert.lenaert@maastrichtuniversity.nl.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Bennett', 'Affiliation': 'Trinity College Institute of Neuroscience, Trinity College Dublin, Dublin, Ireland; Medical Research Council, Cognition and Brain Sciences Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Boddez', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium; Center for the Learning of Psychology and Experimental Psychopathology, KU Leuven, Belgium.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'van Heugten', 'Affiliation': 'School for Mental Health and Neuroscience, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands; Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, the Netherlands; Limburg Brain Injury Centre, the Netherlands.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2021.101656'] 3723,33839618,Isatuximab plus pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma according to prior lines of treatment and refractory status: ICARIA-MM subgroup analysis.,"Patients with relapsed/refractory multiple myeloma (RRMM) experience several relapses, and become refractory to successive therapies. In the ICARIA-MM trial (NCT02990338), isatuximab plus pomalidomide-dexamethasone prolonged median progression-free survival (PFS) in patients with RRMM. This subgroup analysis of ICARIA-MM assessed the treatment benefit of isatuximab by prior lines of therapy and refractory status. A total of 307 patients were randomized to isatuximab-pomalidomide-dexamethasone (n = 154) or pomalidomide-dexamethasone (n = 153). Isatuximab (10 mg/kg intravenously) was given weekly in the first 28-day cycle, then every other week. Standard pomalidomide-dexamethasone doses were given. PFS was assessed by prior lines and refractory status. Overall, 102 (66 %) patients receiving isatuximab-pomalidomide-dexamethasone and 101 (66 %) patients receiving pomalidomide-dexamethasone had received 2-3 prior lines; 52 (34 %) and 52 (34 %) had received >3 prior lines, respectively. Median PFS was higher with isatuximab-pomalidomide-dexamethasone versus pomalidomide-dexamethasone for patients who received 2-3 prior lines of therapy (12.3 vs. 7.8 months) and >3 prior lines of therapy (9.4 vs. 4.3 months). Median PFS was higher with isatuximab-pomalidomide-dexamethasone versus pomalidomide-dexamethasone for patients who were lenalidomide-refractory (11.4 vs. 5.6 months), lenalidomide-refractory at last line (11.6 vs. 5.7 months), refractory to a proteasome inhibitor (PI) (11.4 vs. 5.6 months), and double-refractory (11.2 vs. 4.8 months). Overall response rate (ORR) in patients receiving isatuximab-pomalidomide-dexamethasone versus pomalidomide-dexamethasone was 59.0 % versus 31.4 % in lenalidomide-refractory; 60.2 % versus 32.2 % in PI-refractory; and 58.6 % versus 29.9 % in double-refractory patients. Isatuximab-pomalidomide-dexamethasone improved PFS and ORR regardless of prior lines of therapy or refractory status, consistent with the benefit in the overall population.",2021,"Median PFS was higher with isatuximab-pomalidomide-dexamethasone versus pomalidomide-dexamethasone for patients who were lenalidomide-refractory (11.4 vs. 5.6 months), lenalidomide-refractory at last line (11.6 vs. 5.7 months), refractory to a proteasome inhibitor (PI) (11.4 vs. 5.6 months), and double-refractory (11.2 vs. 4.8 months).","['Patients with relapsed/refractory multiple myeloma (RRMM) experience several relapses', 'patients with RRMM', '307 patients', 'patients receiving', 'n = 154) or', 'patients with relapsed/refractory multiple myeloma according to prior lines of treatment and refractory status: ICARIA-MM subgroup analysis']","['dexamethasone', 'isatuximab plus pomalidomide-dexamethasone', 'isatuximab-pomalidomide-dexamethasone', 'Isatuximab', 'isatuximab-pomalidomide-dexamethasone versus pomalidomide-dexamethasone', 'Isatuximab plus pomalidomide and dexamethasone', 'pomalidomide-dexamethasone', 'Isatuximab-pomalidomide-dexamethasone', 'Standard pomalidomide-dexamethasone']","['Median PFS', 'PFS', 'Overall response rate (ORR', 'median progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C4330502', 'cui_str': 'isatuximab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2347624', 'cui_str': 'pomalidomide'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",307.0,0.285036,"Median PFS was higher with isatuximab-pomalidomide-dexamethasone versus pomalidomide-dexamethasone for patients who were lenalidomide-refractory (11.4 vs. 5.6 months), lenalidomide-refractory at last line (11.6 vs. 5.7 months), refractory to a proteasome inhibitor (PI) (11.4 vs. 5.6 months), and double-refractory (11.2 vs. 4.8 months).","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Bringhen', 'Affiliation': 'Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy. Electronic address: sarabringhen@yahoo.com.'}, {'ForeName': 'Ludek', 'Initials': 'L', 'LastName': 'Pour', 'Affiliation': 'Hematology and Oncology, University Hospital Brno, Brno, Czech Republic.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Vorobyev', 'Affiliation': 'S.P. Botkin Hospital, Moscow, Russia.'}, {'ForeName': 'Filiz', 'Initials': 'F', 'LastName': 'Vural', 'Affiliation': 'Ege University Medical Faculty, Izmir, Turkey.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Warzocha', 'Affiliation': 'Instytut Hematologii i Transfuzjologii, Warsaw, Poland.'}, {'ForeName': 'Lotfi', 'Initials': 'L', 'LastName': 'Benboubker', 'Affiliation': 'Department of Hematology, University Hospital Tours, Tours, France.'}, {'ForeName': 'Youngil', 'Initials': 'Y', 'LastName': 'Koh', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Maisnar', 'Affiliation': 'Charles University Hospital, Hradec Kralove, Czech Republic.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Karlin', 'Affiliation': 'Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Pierre-Benite, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Pavic', 'Affiliation': 'University of Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Campana', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'Solenn', 'Initials': 'S', 'LastName': 'Le Guennec', 'Affiliation': 'Sanofi R&D, Vitry-sur-Seine, France.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Menas', 'Affiliation': 'Aixial (for Sanofi), Boulogne-Billancourt, France.'}, {'ForeName': 'Helgi', 'Initials': 'H', 'LastName': 'van de Velde', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Richardson', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.'}]",Leukemia research,['10.1016/j.leukres.2021.106576'] 3724,33839603,Pembrolizumab+chemotherapy versus atezolizumab+chemotherapy+/-bevacizumab for the first-line treatment of non-squamous NSCLC: A matching-adjusted indirect comparison.,"OBJECTIVES Multiple immunotherapy and chemotherapy combinations are approved for the management of advanced NSCLC which have not been directly compared in randomized clinical trials. This study indirectly compared the effectiveness of pembrolizumab + chemotherapy versus atezolizumab + chemotherapy+/-bevacizumab for previously untreated non-squamous NSCLC patients without EGFR/ALK aberrations. MATERIALS AND METHODS A matching-adjusted indirect comparison (MAIC) was conducted using individual patient data (IPD) from KEYNOTE-021 Cohort G (KN021 G) (pembrolizumab + carboplatin + pemetrexed; N = 59) and KEYNOTE-189 (KN189) (pembrolizumab + pemetrexed + platinum chemotherapy; N = 410) and published aggregate data from IMpower 130 (atezolizumab + carboplatin + nab-paclitaxel; N = 451) and IMpower 150 (atezolizumab + carboplatin + paclitaxel + bevacizumab; N = 356). To adjust for cross-trial differences in baseline characteristics, data from patients randomized to pembrolizumab + chemotherapy in KN021 G/KN189 were reweighted to match the baseline characteristics of patients randomized to atezolizumab + chemotherapy from IMpower 130 or atezolizumab + chemotherapy + bevacizumab from IMpower 150. Outcomes included overall survival (OS), blinded independent review-assessed progression-free survival (PFS) and objective response rate (ORR). OS and PFS follow-up were truncated to the trial with shorter follow-up. Sensitivity analyses were conducted without truncation of follow-up of OS and PFS. RESULTS After matching for cross-trial differences, the effective sample size of pembrolizumab + chemotherapy was 428 and 389 for the IMpower 130 and IMpower 150 comparisons, respectively. The estimated HRs (95 % CIs) of pembrolizumab + chemotherapy versus atezolizumab + chemotherapy were 0.80 (0.67,0.95) and 0.79 (0.67,0.93) with regard to OS and PFS, respectively. For pembrolizumab + chemotherapy versus atezolizumab + chemotherapy + bevacizumab, the estimated HR (95 % CIs) was 0.86 (0.72,1.03) for OS and 0.81 (0.68,0.96) for PFS. For ORR, the estimated risk ratio (95 % CI) and the risk difference (95 % CI) was 0.9 (0.8,1.1) and -3.5 % (-10.0,3.1) for pembrolizumab + chemotherapy versus atezolizumab + chemotherapy, respectively, and 0.8 (0.7,0.9) and -12.2 % (-19.6,-4.8) for pembrolizumab + chemotherapy versus atezolizumab + chemotherapy + bevacizumab, respectively. Findings were consistent across sensitivity analyses for both outcomes. CONCLUSION MAIC results showed a significantly better OS and PFS for pembrolizumab + chemotherapy compared with atezolizumab + chemotherapy and a significantly better PFS for pembrolizumab + chemotherapy compared with atezolizumab + chemotherapy + bevacizumab.",2021,"The estimated HRs (95 % CIs) of pembrolizumab + chemotherapy versus atezolizumab + chemotherapy were 0.80 (0.67,0.95) and 0.79 (0.67,0.93) with regard to OS and PFS, respectively.","['non-squamous NSCLC', 'in KN021', 'previously untreated non-squamous NSCLC patients without EGFR/ALK aberrations']","['Pembrolizumab+chemotherapy versus atezolizumab+chemotherapy+/-bevacizumab', 'atezolizumab\u202f+\u202fchemotherapy', 'pembrolizumab\u202f+\u202fcarboplatin\u202f+\u202fpemetrexed; N\u202f=\u202f59) and KEYNOTE-189 (KN189) (pembrolizumab\u202f+\u202fpemetrexed\u202f+\u202fplatinum chemotherapy; N\u202f=\u202f410) and published aggregate data from IMpower 130 (atezolizumab\u202f+\u202fcarboplatin\u202f+\u202fnab-paclitaxel; N\u202f=\u202f451) and IMpower 150 (atezolizumab\u202f+\u202fcarboplatin\u202f+\u202fpaclitaxel\u202f+\u202fbevacizumab', '\u202fchemotherapy\u202f+\u202fbevacizumab', 'atezolizumab\u202f+\u202fchemotherapy\u202f+\u202fbevacizumab', 'pembrolizumab\u202f+\u202fchemotherapy versus atezolizumab\u202f+\u202fchemotherapy\u202f+\u202fbevacizumab', 'atezolizumab\u202f+\u202fchemotherapy from IMpower 130 or atezolizumab', 'pembrolizumab\u202f+\u202fchemotherapy', 'pembrolizumab\u202f+\u202fchemotherapy versus atezolizumab\u202f+\u202fchemotherapy+/-bevacizumab']","['overall survival (OS), blinded independent review-assessed progression-free survival (PFS) and objective response rate (ORR', 'OS and PFS']","[{'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1663627', 'cui_str': 'ALK protein, human'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0034037', 'cui_str': 'Publishing'}, {'cui': 'C0205418', 'cui_str': 'Aggregate'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C5191282', 'cui_str': '451'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",,0.207477,"The estimated HRs (95 % CIs) of pembrolizumab + chemotherapy versus atezolizumab + chemotherapy were 0.80 (0.67,0.95) and 0.79 (0.67,0.93) with regard to OS and PFS, respectively.","[{'ForeName': 'Balazs', 'Initials': 'B', 'LastName': 'Halmos', 'Affiliation': 'Department of Oncology, Montefiore/Albert Einstein Cancer Center, 2nd Floor, 1695 Eastchester Rd, Bronx, NY, 10461, USA. Electronic address: bahalmos@montefiore.org.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Burke', 'Affiliation': 'Center for Observational & Real World Evidence (CORE), Merck & Co., Inc., Kenilworth, NJ, 07033, USA. Electronic address: thomas_burke2@merck.com.'}, {'ForeName': 'Chrysostomos', 'Initials': 'C', 'LastName': 'Kalyvas', 'Affiliation': 'Biostatistics and Research Decision Sciences, MSD Europe, Inc., Brussels, 1200, Belgium. Electronic address: chrysostomos.kalyvas@merck.com.'}, {'ForeName': 'Kristel', 'Initials': 'K', 'LastName': 'Vandormael', 'Affiliation': 'Biostatistics and Research Decision Sciences, MSD Europe, Inc., Brussels, 1200, Belgium. Electronic address: kristel_vandormael@merck.com.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Frederickson', 'Affiliation': 'precisionHEOR, Oakland, CA, 94612, USA. Electronic address: andrew.frederickson@precisionvh.com.'}, {'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Piperdi', 'Affiliation': 'Oncology Clinical Development, Merck & Co., Inc., Kenilworth, NJ, 07033, USA. Electronic address: bilal.piperdi@merck.com.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2021.03.020'] 3725,33839602,Effectiveness of a one day self-compassion training for pediatric nurses' resilience.,"BACKGROUND Resilience is a critical skill for nurses and other healthcare professionals, especially during the COVID-19 pandemic, yet few nurses receive training that promotes emotional awareness and regulation, resilience, and self-compassion. PURPOSE The purpose of this study was to understand if attending a one-day workshop format of the Self Compassion for Healthcare Communities (SCHC) program would improve pediatric nurses' resilience, well-being, and professional quality of life. DESIGN AND METHODS Following a quasi-experimental design, pre, post, and follow-up surveys were acquired from 22 nurses who attended the training and 26 nurses who did not attend the training. In a linear mixed models regression analysis, changes in self-compassion, mindfulness, compassion, resilience, job engagement, professional quality of life (compassion satisfaction, burnout, and secondary traumatic stress), depression, anxiety and stress were analyzed between groups. RESULTS Participants in the intervention exhibited significant increases in self-compassion, mindfulness, compassion to others, resilience and compassion satisfaction, and significant decreases in burnout, anxiety, and stress compared to the non-intervention group. CONCLUSIONS A one-day SCHC training program provides nurses with knowledge and skills to increase their resilience and support their emotional well-being and professional quality of life. PRACTICE IMPLICATIONS Nurses' schedules may hamper their ability to attend lengthy resilience trainings, yet the skills needed for resilience are crucial to decreasing burnout, empathy fatigue, and turnover. Offering an effective, one-day training provides an accessible alternative for nurses to gain knowledge and skills that increase resilience.",2021,"RESULTS Participants in the intervention exhibited significant increases in self-compassion, mindfulness, compassion to others, resilience and compassion satisfaction, and significant decreases in burnout, anxiety, and stress compared to the non-intervention group. ","['22 nurses who attended the training and 26 nurses who did not attend the training', ""pediatric nurses' resilience"", 'attending a one-day workshop format of the Self Compassion for Healthcare Communities (SCHC) program']",['one day self-compassion training'],"['resilience and support their emotional well-being and professional quality of life', ""pediatric nurses' resilience, well-being, and professional quality of life"", 'self-compassion, mindfulness, compassion to others, resilience and compassion satisfaction', 'self-compassion, mindfulness, compassion, resilience, job engagement, professional quality of life (compassion satisfaction, burnout, and secondary traumatic stress), depression, anxiety and stress', 'burnout, anxiety, and stress']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0559294', 'cui_str': 'Did not attend'}, {'cui': 'C0030753', 'cui_str': 'Nursing, Pediatric'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030753', 'cui_str': 'Nursing, Pediatric'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C4042834', 'cui_str': 'Vicarious Traumatization'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",,0.0147981,"RESULTS Participants in the intervention exhibited significant increases in self-compassion, mindfulness, compassion to others, resilience and compassion satisfaction, and significant decreases in burnout, anxiety, and stress compared to the non-intervention group. ","[{'ForeName': 'Phoebe Long', 'Initials': 'PL', 'LastName': 'Franco', 'Affiliation': ""Center for Resiliency, Dell Children's Medical Center, USA. Electronic address: phoebe.long@ascension.org.""}, {'ForeName': 'LeeAnn M', 'Initials': 'LM', 'LastName': 'Christie', 'Affiliation': ""Quality Improvement and Patient Safety, Dell Children's Medical Center, USA.""}]",Journal of pediatric nursing,['10.1016/j.pedn.2021.03.020'] 3726,33839594,The effect of animal-assisted therapy on nursing student anxiety: A randomized control study.,"BACKGROUND AND OBJECTIVE Nursing student stress has a major impact on academic performance and testing anxiety is one prominent source. This study evaluated the influence of dogs in decreasing student anxiety at a nursing program prior to a medication dosage calculation exam. METHOD This study uses a convenience sample randomly assigned to a control and intervention group with a pre-pre, pre, post and post-post-test using the Spielberger State-Trait Anxiety Inventory. The intervention group experienced a therapy dog intervention prior to the medication dosage calculation exam. RESULTS Using a repeated measures one-way MANOVA, there was a statistically significance difference between intervention and control groups Wilk's ∧ = 0.761, F(8, 79) = 3.103, p < 0.01. CONCLUSION A brief interaction with therapy dogs prior to a medication calculation exam decreased anxiety in a convenience sample of nursing students. This study adds empirical knowledge to the field of animal-assisted therapy and nursing student anxiety-coping methods.",2021,"Using a repeated measures one-way MANOVA, there was a statistically significance difference between intervention and control groups Wilk's ∧ = ","['nursing student anxiety', 'convenience sample of nursing students']","['animal-assisted therapy', 'therapy dog intervention prior to the medication dosage calculation exam']",['student anxiety'],"[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0150133', 'cui_str': 'Animal-assisted therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0012984', 'cui_str': 'Canis lupus familiaris'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1441506', 'cui_str': 'Calculation technique'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.00604902,"Using a repeated measures one-way MANOVA, there was a statistically significance difference between intervention and control groups Wilk's ∧ = ","[{'ForeName': 'Della', 'Initials': 'D', 'LastName': 'Anderson', 'Affiliation': 'University of Kansas, 1450 Jayhawk Boulevard, Lawrence, KS 66045, USA. Electronic address: dellaanderson@ku.edu.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Brown', 'Affiliation': 'University of Kansas, 1450 Jayhawk Boulevard, Lawrence, KS 66045, USA. Electronic address: stephanielbrown@ku.edu.'}]",Nurse education in practice,['10.1016/j.nepr.2021.103042'] 3727,33839586,Examining weight suppression as a predictor and moderator of intervention outcomes in an eating disorder and obesity prevention trial: A replication and extension study.,"Weight suppression (WS) predicts future weight gain and increases in eating disorder symptoms in community and clinical samples but has received minimal attention in obesity and eating disorder prevention programs. In a sample of emerging adults (N = 364) in a randomized controlled trial evaluating two obesity and eating disorder prevention interventions versus a control condition, this study aimed to replicate the findings that WS and its interaction with baseline BMI predict increases in weight and eating disorder symptoms and test a novel hypothesis that WS would moderate the effects of the interventions on change in weight and eating disorder symptoms. Participants completed assessments at baseline, post-intervention, 6-, 12-, and 24-months. WS was calculated as the difference between highest lifetime weight and baseline weight. WS interacted with baseline BMI to predict greater weight gain over 24-months, such that those with high WS and lower baseline BMI gained weight most rapidly. WS did not predict eating disorder symptom change and did not moderate the effects of the prevention programs. Given that individuals with WS are at increased risk for weight gain, expressly targeting this high-risk population with evidence-based obesity prevention programs may be useful. CLINICALTRIALS.GOV REGISTRATION: NCT01680224.",2021,WS did not predict eating disorder symptom change and did not moderate the effects of the prevention programs.,[],"['obesity and eating disorder prevention interventions', 'Weight suppression (WS']","['change in weight and eating disorder symptoms', 'eating disorder symptom change', 'weight and eating disorder symptoms', 'weight gain']",[],"[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",,0.18371,WS did not predict eating disorder symptom change and did not moderate the effects of the prevention programs.,"[{'ForeName': 'Christine C', 'Initials': 'CC', 'LastName': 'Call', 'Affiliation': 'Department of Psychology, Drexel University, Stratton Hall Suite 119, 3141 Chestnut St, Philadelphia, PA, 19104, USA; Center for Weight, Eating and Lifestyle Science, Drexel University, Stratton Hall Second Floor, 3201 Chestnut St, Philadelphia, PA, 19104, USA. Electronic address: cc3397@drexel.edu.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': ""D'Adamo"", 'Affiliation': 'Department of Psychology, Drexel University, Stratton Hall Suite 119, 3141 Chestnut St, Philadelphia, PA, 19104, USA; Center for Weight, Eating and Lifestyle Science, Drexel University, Stratton Hall Second Floor, 3201 Chestnut St, Philadelphia, PA, 19104, USA. Electronic address: lad374@drexel.edu.'}, {'ForeName': 'Meghan L', 'Initials': 'ML', 'LastName': 'Butryn', 'Affiliation': 'Department of Psychology, Drexel University, Stratton Hall Suite 119, 3141 Chestnut St, Philadelphia, PA, 19104, USA; Center for Weight, Eating and Lifestyle Science, Drexel University, Stratton Hall Second Floor, 3201 Chestnut St, Philadelphia, PA, 19104, USA. Electronic address: mlb34@drexel.edu.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Stice', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, 401 Quarry Road, Stanford, CA, 94305-5101, USA. Electronic address: estice@stanford.edu.'}]",Behaviour research and therapy,['10.1016/j.brat.2021.103850'] 3728,33839523,A feasibility trial of acupuncture in cancer patients undergoing radiotherapy treatment.,"OBJECTIVE We conducted a feasibility trial of acupuncture in cancer patients undergoing radiotherapy treatment. The trial included training radiographers to deliver acupuncture within patients' routine NHS care. METHODS Mixed methods pragmatic randomized parallel-group exploratory feasibility trial comparing standard care to standard care plus acupuncture. RESULTS Most aspects of the research design and acupuncture intervention were acceptable to the 101 participants. Participants' valued the opportunity to receive acupuncture within their NHS care, perceived the treatment as eliciting a number of beneficial effects, and had a positive impact on their NHS cancer treatment. However, quantitative analysis of outcome measure data revealed no consistent significant differences between those receiving standard care and those receiving standard care plus acupuncture. CONCLUSION It is feasible to implement acupuncture in a busy radiotherapy unit provided by specially trained radiographers. The methodology employed appears acceptable for the evaluation of acupuncture for radiotherapy patients.",2021,"However, quantitative analysis of outcome measure data revealed no consistent significant differences between those receiving standard care and those receiving standard care plus acupuncture. ","[""within patients' routine NHS care"", 'cancer patients undergoing radiotherapy treatment', '101 participants']","['acupuncture', 'acupuncture intervention', 'standard care to standard care plus acupuncture']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With'}]",[],,0.325267,"However, quantitative analysis of outcome measure data revealed no consistent significant differences between those receiving standard care and those receiving standard care plus acupuncture. ","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hughes', 'Affiliation': 'Royal London Hospital for Integrated Medicine, UCLH NHS Trust and University of West London, UK. Electronic address: John.Hughes8@nhs.net.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Gyertson', 'Affiliation': 'University College London Cancer Clinical Trials Unit, UCLH NHS Trust, UK.'}, {'ForeName': 'Lallita', 'Initials': 'L', 'LastName': 'Carballo', 'Affiliation': 'Macmillan Cancer Support, UCLH NHS Trust, UK.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Plant', 'Affiliation': 'Macmillan Cancer Support, UCLH NHS Trust, UK.'}, {'ForeName': 'Mitch', 'Initials': 'M', 'LastName': 'Sharman', 'Affiliation': 'Department of Radiotherapy, UCLH NHS Trust, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Ruane', 'Affiliation': 'Patient Representative, UCH Macmillian Cancer Centre, Bloomsbury, London, WC1E 6AG, UK.'}, {'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Mendoza-Naranjo', 'Affiliation': 'Late-stage Clinical Development, Oncology R&D, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hackshaw', 'Affiliation': 'Cancer Research UK & UCL Cancer Trials Centre, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Cummings', 'Affiliation': 'British Medical Acupuncture Society, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Edwards', 'Affiliation': 'Datanova Ltd, UK.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Lewith', 'Affiliation': 'Deceased, Formerly Department of Primary Care, University of Southampton, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fisher', 'Affiliation': 'Deceased, Formerly Royal London Hospital for Integrated Medicine, UCLH NHS Trust, UK.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101372'] 3729,33839465,Pilot assessment of omega-3 fatty acids and potassium thiocyanate in sickle cell anemia patients with conditional peak systolic cerebral artery blood velocity.,"OBJECTIVE The purpose of this pilot study was to explore the effect of omega-3 fatty acids and potassium thiocyanate on conditional peak systolic cerebral artery blood velocity in children with sickle cell anemia (SCA). METHODS Transcranial doppler ultrasonography (TCD) was done on 232 SCA children, and 21 found with conditional peak systolic blood velocity (PSV) of 200-249 cm/s in internal carotid, middle or anterior cerebral arteries. These were randomized to receive omega-3 fatty acids and potassium thiocyanate with standard treatment of SCA (test group, N = 14), or standard treatment only (control group, N = 7). After 3 months of treatment, PSV was measured again. RESULTS Right middle cerebral artery PSV was significantly reduced in the test relative to the control groups (p = 0.04). PSV returned to normal in 79% of the test versus 43% of the control group; and increased to abnormal in one member of the control group, but none of the test group. CONCLUSIONS The pilot data suggest that in SCA, omega-3 fatty acids and potassium thiocyanate might reduce conditional blood velocity to normal, or prevent progression to abnormal values. A larger, randomized, clinical trial is required to further address the current gap in management of conditional TCD blood velocity.",2021,Right middle cerebral artery PSV was significantly reduced in the test relative to the control groups (p = 0.04).,"['sickle cell anemia patients with conditional peak systolic cerebral artery blood velocity', 'children with sickle cell anemia (SCA', '232 SCA children, and 21 found with conditional peak systolic blood velocity (PSV) of 200-249\u202fcm/s in internal carotid, middle or anterior cerebral arteries']","['Transcranial doppler ultrasonography (TCD', 'omega-3 fatty acids and potassium thiocyanate', 'SCA, omega-3 fatty acids and potassium thiocyanate', 'omega-3 fatty acids and potassium thiocyanate with standard treatment of SCA']","['PSV', 'Right middle cerebral artery PSV', 'conditional peak systolic cerebral artery blood velocity']","[{'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic'}, {'cui': 'C0007770', 'cui_str': 'Structure of cerebral artery'}, {'cui': 'C1531610', 'cui_str': 'Blood velocity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439392', 'cui_str': 'cm/s'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0149561', 'cui_str': 'Structure of anterior cerebral artery'}]","[{'cui': 'C0206077', 'cui_str': 'Transcranial doppler ultrasonography'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0071785', 'cui_str': 'Potassium thiocyanate'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0442710', 'cui_str': 'Peak systolic'}, {'cui': 'C1531610', 'cui_str': 'Blood velocity'}, {'cui': 'C0226213', 'cui_str': 'Structure of right middle cerebral artery'}, {'cui': 'C0007770', 'cui_str': 'Structure of cerebral artery'}]",232.0,0.150749,Right middle cerebral artery PSV was significantly reduced in the test relative to the control groups (p = 0.04).,"[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Ugwu', 'Affiliation': 'Department of Hematology, University of Nigeria College of Medicine, Enugu, Nigeria.'}, {'ForeName': 'Nneka', 'Initials': 'N', 'LastName': 'Iloanusi', 'Affiliation': 'Department of Radiation Medicine, University of Nigeria College of Medicine, Enugu, Nigeria.'}, {'ForeName': 'Ngozi', 'Initials': 'N', 'LastName': 'Ugwu', 'Affiliation': 'Department of Hematology, Alex Ekwueme Federal University Teaching Hospital, Abakaliki, Nigeria.'}, {'ForeName': 'Barth', 'Initials': 'B', 'LastName': 'Chukwu', 'Affiliation': 'Department of Pediatrics, University of Nigeria College of Medicine, Enugu, Nigeria.'}, {'ForeName': 'Osita', 'Initials': 'O', 'LastName': 'Ezenwosu', 'Affiliation': 'Department of Pediatrics, University of Nigeria College of Medicine, Enugu, Nigeria.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Modebe', 'Affiliation': 'Department of Radiation Medicine, University of Nigeria College of Medicine, Enugu, Nigeria.'}, {'ForeName': 'Augustine', 'Initials': 'A', 'LastName': 'Duru', 'Affiliation': 'Department of Hematology, University of Nigeria College of Medicine, Enugu, Nigeria.'}, {'ForeName': 'Anazoeze', 'Initials': 'A', 'LastName': 'Madu', 'Affiliation': 'Department of Hematology, University of Nigeria College of Medicine, Enugu, Nigeria.'}, {'ForeName': 'Ezinne', 'Initials': 'E', 'LastName': 'Chibueze', 'Affiliation': 'National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Igboke', 'Affiliation': 'Department of Radiology, Alex Ekwueme Federal University Teaching Hospital, Abakaliki, Nigeria.'}, {'ForeName': 'Obiora', 'Initials': 'O', 'LastName': 'Ejiofor', 'Affiliation': 'Department of Pediatrics, Chukwuemeka Odumegwu Ojukwu University Teaching Hospital, Awka, Nigeria.'}, {'ForeName': 'Chilota', 'Initials': 'C', 'LastName': 'Efobi', 'Affiliation': 'Department of Hematology, Chukwuemeka Odumegwu Ojukwu University Teaching Hospital, Awka, Nigeria.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Uchendu', 'Affiliation': 'Department of Radiology, Alex Ekwueme Federal University Teaching Hospital, Abakaliki, Nigeria.'}, {'ForeName': 'Iheanyi', 'Initials': 'I', 'LastName': 'Okpala', 'Affiliation': 'Department of Hematology, University of Nigeria College of Medicine, Enugu, Nigeria. Electronic address: iheanyi.okpala@unn.edu.ng.'}]","Blood cells, molecules & diseases",['10.1016/j.bcmd.2021.102564'] 3730,33839429,"Does the use of self-compression in mammography affect compression force, breast thickness, and mean glandular dose?","PURPOSE The purpose of the study was to investigate whether the use of self-compression in craniocaudal (CC) projection has an effect on compression force, breast thickness, radiation dose and image quality compared to the standard mammographic procedure. METHODS The study was conducted on 200 female patients that were referred for mammographic imaging. Patients were randomly divided into two equal groups. In the first group, self-compression was performed on the right breast and in the second group on the left breast. The data about compression force (N), breast thickness (mm), and mean glandular dose (MGD; mGy) were collected. In addition, the differences in the mentioned variables according to the side of self-compression were compared. All mammographic images were evaluated by two experienced radiologists according to the criteria established by the European Commission. RESULTS The use of self-compression resulted in a significant increase in compression force by 21.7 % (19.8 N) and a significant reduction of breast thickness by 5% (2.43 mm) and MGD by 6.3 % (0.09 mGy), respectively. There were no statistically significant differences based on the self-compression side, and no differences were observed in image quality assessment. CONCLUSION This study demonstrates that the imaging protocol in mammography of the CC projection can be adopted by the use of self-compression in order to achieve better results.",2021,"There were no statistically significant differences based on the self-compression side, and no differences were observed in image quality assessment. ",['200 female patients that were referred for mammographic imaging'],['self-compression in craniocaudal (CC) projection'],"['compression force', 'compression force, breast thickness, radiation dose and image quality', 'image quality assessment', 'breast thickness', 'data about compression force (N), breast thickness (mm), and mean glandular dose (MGD; mGy']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0442215', 'cui_str': 'Cranio-caudal projection'}]","[{'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0225353', 'cui_str': 'Glandular'}, {'cui': 'C3873195', 'cui_str': 'mGy'}]",200.0,0.0178592,"There were no statistically significant differences based on the self-compression side, and no differences were observed in image quality assessment. ","[{'ForeName': 'Erna', 'Initials': 'E', 'LastName': 'Alukic', 'Affiliation': 'University of Ljubljana, Faculty of Health Sciences, Medical Imaging and Radiotherapy Department, Zdravstvena pot 5, 1000, Ljubljana, Slovenia.'}, {'ForeName': 'Polona', 'Initials': 'P', 'LastName': 'Bravhar', 'Affiliation': 'University Medical Centre Ljubljana, Institute of Radiology, Zaloška 7, 1000, Ljubljana, Slovenia.'}, {'ForeName': 'Nejc', 'Initials': 'N', 'LastName': 'Mekis', 'Affiliation': 'University of Ljubljana, Faculty of Health Sciences, Medical Imaging and Radiotherapy Department, Zdravstvena pot 5, 1000, Ljubljana, Slovenia. Electronic address: nejc.mekis@zf.uni-lj.si.'}]",European journal of radiology,['10.1016/j.ejrad.2021.109694'] 3731,33839424,The apex angle of the rocker sole affects the posture and gait stability of healthy individuals.,"BACKGROUND Rocker sole (RS) shoes have been linked to impaired postural control. However, which features of RS design affect balance is unclear. RESEARCH QUESTION Which RS design features affect standing balance and gait stability? METHODS This study utilized an intervention and cross-over design. Twenty healthy young adults (10 males and 10 females) participated in this study. Standing balance and gait stability were measured using a single force platform and three-dimensional motion analysis system, respectively. The experimental conditions included the control shoe and five RS shoes in the combination of apex position (%) and apex angle (degree) for RS50-95, RS60-95, RS70-95, RS60-70, and RS60-110. The main outcome measures were the area surrounding the maximal rectangular amplitude, mean path length, average displacement of the center of pressure along the lateral and anterior/posterior directions, and maximal center of pressure excursion as the standing balance and lateral margin of stability as the gait stability. Statistical analyses were conducted using a two-way split-plot analysis of variance with repeated measures (with RS design as the within-subject factor and sex as the between-subject factor) and the Bonferroni post hoc test (α = .05). RESULTS Regarding the mean path length, RS60-70 was significantly longer than the control shoe, and it showed a significantly increased lateral margin of stability. Thus, RS60-70 was shown to affect standing balance, limit of stability, and gait stability of the frontal plane during gait. SIGNIFICANCE These results suggest that the apex angle of the RS design feature affects standing balance and gait stability, and RS60-70 is detrimental to stability. Therefore, when RS with a small apex angle is prescribed, it is necessary to consider the patient's balance ability.",2021,"Regarding the mean path length, RS60-70 was significantly longer than the control shoe, and it showed a significantly increased lateral margin of stability.","['healthy individuals', 'Twenty healthy young adults (10 males and 10 females']",['Rocker sole (RS) shoes'],"['lateral margin of stability', 'Standing balance and gait stability', 'area surrounding the maximal rectangular amplitude, mean path length, average displacement of the center of pressure along the lateral and anterior/posterior directions, and maximal center of pressure excursion as the standing balance and lateral margin of stability as the gait stability', 'mean path length, RS60-70', 'standing balance, limit of stability, and gait stability']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0036988', 'cui_str': 'Shoes'}]","[{'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1282914', 'cui_str': 'Circumscribed'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0205142', 'cui_str': 'Rectangular'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]",20.0,0.0603811,"Regarding the mean path length, RS60-70 was significantly longer than the control shoe, and it showed a significantly increased lateral margin of stability.","[{'ForeName': 'Yoshiteru', 'Initials': 'Y', 'LastName': 'Watanabe', 'Affiliation': 'Department of Informatics, Graduate School of Informatics and Engineering, The University of Electro-communications, 1-5-1 Chofugaoka, Chofu, Tokyo, 182-8585, Japan; Department of Physical Therapy, School of Health Sciences, Tokyo University of Technology, 5-23-22 Nishikamata, Ota-ku, Tokyo, 144-8535, Japan. Electronic address: watanabeyt@stf.teu.ac.jp.'}, {'ForeName': 'Nobuhide', 'Initials': 'N', 'LastName': 'Kawabe', 'Affiliation': 'Department of Physical Therapy, Tohto University, Makuhari Techno Garden E Building 1-3 Nakase, Mihama-ku, Chiba, 261-8501, Japan. Electronic address: nobuhide.kawabe@tohto.ac.jp.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Mito', 'Affiliation': 'Department of Informatics, Graduate School of Informatics and Engineering, The University of Electro-communications, 1-5-1 Chofugaoka, Chofu, Tokyo, 182-8585, Japan. Electronic address: k.mito@uec.ac.jp.'}]",Gait & posture,['10.1016/j.gaitpost.2021.03.033'] 3732,33839372,Randomized controlled trial of an adjunctive sulforaphane nutraceutical in schizophrenia.,,2021,,['schizophrenia'],['adjunctive sulforaphane'],[],"[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0163159', 'cui_str': 'sulforafan'}]",[],,0.482217,,"[{'ForeName': 'Faith', 'Initials': 'F', 'LastName': 'Dickerson', 'Affiliation': 'Sheppard Pratt, 6501 North Charles St., Baltimore, MD 21204, United States of America. Electronic address: fdickerson@sheppardpratt.org.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Origoni', 'Affiliation': 'Sheppard Pratt, 6501 North Charles St., Baltimore, MD 21204, United States of America.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Katsafanas', 'Affiliation': 'Sheppard Pratt, 6501 North Charles St., Baltimore, MD 21204, United States of America.'}, {'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Squire', 'Affiliation': 'Sheppard Pratt, 6501 North Charles St., Baltimore, MD 21204, United States of America.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Newman', 'Affiliation': 'Sheppard Pratt, 6501 North Charles St., Baltimore, MD 21204, United States of America.'}, {'ForeName': 'Jed', 'Initials': 'J', 'LastName': 'Fahey', 'Affiliation': 'Johns Hopkins School of Medicine, Division of Clinical Pharmacology, Department of Medicine, 855 North Wolfe Street, Baltimore, MD 21205, United States of America.'}, {'ForeName': 'Jian-Chun', 'Initials': 'JC', 'LastName': 'Xiao', 'Affiliation': 'Johns Hopkins School of Medicine, Stanley Neurovirology Laboratory, 600 North Wolfe St., Baltimore, MD 21205, United States of America.'}, {'ForeName': 'Cassie', 'Initials': 'C', 'LastName': 'Stallings', 'Affiliation': 'Sheppard Pratt, 6501 North Charles St., Baltimore, MD 21204, United States of America.'}, {'ForeName': 'Joshana', 'Initials': 'J', 'LastName': 'Goga', 'Affiliation': 'Sheppard Pratt, 6501 North Charles St., Baltimore, MD 21204, United States of America.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Khushalani', 'Affiliation': 'Sheppard Pratt, 6501 North Charles St., Baltimore, MD 21204, United States of America.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Yolken', 'Affiliation': 'Johns Hopkins School of Medicine, Stanley Neurovirology Laboratory, 600 North Wolfe St., Baltimore, MD 21205, United States of America.'}]",Schizophrenia research,['10.1016/j.schres.2021.03.018'] 3733,31747132,Eligibility of sodium-glucose co-transporter-2 inhibitors among patients with diabetes mellitus admitted for heart failure.,"AIMS Sodium-glucose co-transporter (SGLT)-2 inhibitors have been shown to reduce the risk of cardiovascular death and heart failure (HF) hospitalization in patients with type 2 diabetes mellitus (DM) and high cardiovascular risk in two large clinical outcome trials: empagliflozin in EMPA-REG OUTCOME and canagliflozin in CANVAS. The scope of eligibility for SGLT-2 inhibitors (empagliflozin and canagliflozin) among patients with type 2 DM and HF, based on clinical trial criteria and current US Food and Drug Administration (FDA) labelling criteria, remains unknown. METHODS AND RESULTS Using data from the US Get With The Guidelines (GWTG)-Heart Failure registry, we evaluated the proportion of patients with DM and HF eligible for SGLT-2 inhibitor therapy based on the clinical trial criteria and the US FDA labelling criteria. The GWTG-HF registry is a quality improvement registry of patients admitted in hospital with HF in the USA. We included GWTG-HF registry participants meeting eligibility criteria hospitalized between August 2014 and 30 June 2017 from sites fully participating in the registry. The initial inclusion time point reflects when both drugs had FDA approval. Among the 139 317 patients (out of 407 317) with DM hospitalized with HF (in 460 hospitals; 2014 to 2017), the median age was 71 years, 47% (n = 65 685) were female, and 43% (n = 59 973) had HF with reduced ejection fraction. Overall, 43% (n = 59 943) were eligible for the EMPA-REG OUTCOME trial, 45% (n = 62 818) were eligible for the CANVAS trial, and 34% (n = 47 747) of patients were eligible for either SGLT-2 inhibitors based on the FDA labelling criteria. Among the FDA-eligible patients, 91.5% (n = 43 708) were eligible for either the EMPA-REG OUTCOME trial or the CANVAS trial. Patients who were FDA eligible, compared with those who were not, were younger (70.0 vs. 72.0 years of age), more likely to be male (57.7 vs. 50.3%), and had less burden of co-morbidities. CONCLUSIONS The majority of patients with DM who are hospitalized with HF are not eligible for SGLT-2 inhibitor therapies. Ongoing studies evaluating the safety and efficacy of SGLT-2 inhibitors among patients with HF may potentially broaden the population that may benefit from these therapies.",2020,"Among the FDA-eligible patients, 91.5% (n = 43 708) were eligible for either the EMPA-REG OUTCOME trial or the CANVAS trial.","['139\xa0317 patients (out of 407\xa0317) with DM hospitalized with HF (in 460 hospitals; 2014 to 2017), the median age was 71\xa0years, 47% (n\xa0=\xa065\xa0685) were female, and 43% ', 'Patients who were FDA eligible, compared with those who were not, were younger (70.0 vs. 72.0\xa0years of age), more likely to be male (57.7 vs. 50.3%), and had less burden', 'patients with type 2 DM and HF', 'n\xa0=\xa062\xa0818) were eligible for the CANVAS trial, and 34% (n\xa0', 'patients with DM and HF eligible for SGLT-2 inhibitor therapy based on the clinical trial criteria and the US FDA labelling criteria', '47\xa0747) of patients were eligible for either SGLT-2 inhibitors based on the FDA labelling criteria', 'patients with DM who are hospitalized with HF are not eligible for SGLT-2 inhibitor therapies', 'patients admitted in hospital with HF in the USA', 'participants meeting eligibility criteria hospitalized between August 2014 and 30 June 2017 from sites fully participating in the registry', 'patients with HF', 'patients with diabetes mellitus admitted for heart failure', 'patients with type 2 diabetes mellitus (DM']","['Sodium-glucose co-transporter (SGLT)-2 inhibitors', 'sodium-glucose co-transporter-2 inhibitors', 'empagliflozin', 'SGLT-2 inhibitors (empagliflozin and canagliflozin', 'SGLT-2 inhibitors']","['HF with reduced ejection fraction', 'cardiovascular death and heart failure (HF) hospitalization']","[{'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}]","[{'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",407317.0,0.276569,"Among the FDA-eligible patients, 91.5% (n = 43 708) were eligible for either the EMPA-REG OUTCOME trial or the CANVAS trial.","[{'ForeName': 'Abhinav', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Duke Clinical Research Institute, Duke University, 200 Morris Street, Durham, NC, 27701, USA.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Duke Clinical Research Institute, Duke University, 200 Morris Street, Durham, NC, 27701, USA.'}, {'ForeName': 'Justin A', 'Initials': 'JA', 'LastName': 'Ezekowitz', 'Affiliation': 'Faculty of Medicine and Dentistry, Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Gary Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Duke Clinical Research Institute, Duke University, 200 Morris Street, Durham, NC, 27701, USA.'}, {'ForeName': 'Jacob A', 'Initials': 'JA', 'LastName': 'Udell', 'Affiliation': ""Peter Munk Cardiac Centre, University Health Network and Women's College Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Heidenreich', 'Affiliation': ""Veterans' Affairs Palo Alto Health Care System, Palo Alto, CA, USA.""}, {'ForeName': 'Gregg C', 'Initials': 'GC', 'LastName': 'Fonarow', 'Affiliation': 'The Ahmanson-University of California Los Angeles Cardiomyopathy Centre, Ronald Regan University of California Los Angeles Medical Centre, Los Angeles, CA, USA.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute, Duke University, 200 Morris Street, Durham, NC, 27701, USA.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Duke Clinical Research Institute, Duke University, 200 Morris Street, Durham, NC, 27701, USA.'}]",ESC heart failure,['10.1002/ehf2.12528'] 3734,31786114,Open Versus Closed Pleura Internal Mammary Artery Harvesting and Early Pulmonary Function After Coronary Artery Bypass Grafting.,"BACKGROUND The internal mammary artery is the vessel of choice for myocardial revascularisation during coronary artery bypass grafting (CABG). Although it is possible to harvest the left internal mammary artery (LIMA) without opening the left pleura, pleurotomy is usually performed to provide adequate exposure and allow the placement of the LIMA medial to the upper lobe, preventing any undue tension on the mammary pedicle. However, the intact pleura technique may have a lower risk of postoperative pulmonary complications. We aimed to study the effects of both procedures on pulmonary function and the incidence of complications. METHOD One hundred patients with ischaemic heart disease indicated for CABG were included and divided into two groups. The closed pleural technique group included 50 patients with preservation of the pleural integrity during mammary harvesting. The open pleural procedure group included 50 patients without preservation of pleural integrity. Spirometry was done pre- and postoperatively in both groups and postoperative pulmonary complications in both groups were recorded and analysed. RESULTS Internal mammary harvesting with preservation of pleural integrity during CABG in patients in the closed pleural procedure group showed significant improvement in forced expiratory volume in the first second (FEV1%), forced vital capacity (FVC%), and FEV1/FVC compared with the corresponding values in patients in the open pleural procedure group, on day 5 postoperatively, at discharge, and at day 30. There were fewer complications in preservation of pleural integrity with regard to lung atelectasis and pleural effusion, which were significantly lower in patients in the open pleural procedure group. CONCLUSIONS Preservation of pleural integrity has beneficial effects on pulmonary function and has fewer associated pulmonary complications.",2020,"There were fewer complications in preservation of pleural integrity with regard to lung atelectasis and pleural effusion, which were significantly lower in patients in the open pleural procedure group. ","['50 patients without preservation of pleural integrity', 'After Coronary Artery Bypass Grafting', 'One hundred patients with ischaemic heart disease indicated for CABG', '50 patients with preservation of the pleural integrity during mammary harvesting']","['coronary artery bypass grafting (CABG', 'Open Versus Closed Pleura Internal Mammary Artery Harvesting and Early Pulmonary Function']","['pulmonary function and the incidence of complications', 'forced expiratory volume', 'forced vital capacity (FVC%), and FEV1/FVC', 'postoperative pulmonary complications', 'pleural integrity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C1522720', 'cui_str': 'Pleural'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0032225', 'cui_str': 'Pleural structure'}, {'cui': 'C0226276', 'cui_str': 'Structure of internal thoracic artery'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C1522720', 'cui_str': 'Pleural'}, {'cui': 'C0205266', 'cui_str': 'Intact'}]",100.0,0.0053606,"There were fewer complications in preservation of pleural integrity with regard to lung atelectasis and pleural effusion, which were significantly lower in patients in the open pleural procedure group. ","[{'ForeName': 'Moataz E', 'Initials': 'ME', 'LastName': 'Rezk', 'Affiliation': 'Benha University, Faculty of Medicine, Cardiothoracic Department, Benha, Egypt.'}, {'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'Elgazzar', 'Affiliation': 'Benha University, Faculty of Medicine, Cardiothoracic Department, Benha, Egypt.'}, {'ForeName': 'Shaimaa M', 'Initials': 'SM', 'LastName': 'Abo Youssef', 'Affiliation': 'Benha University, Faculty of Medicine, Chest Department, Benha, Egypt.'}, {'ForeName': 'Ahmed S', 'Initials': 'AS', 'LastName': 'Emeraa', 'Affiliation': 'Benha University, Faculty of Medicine, Cardiothoracic Department, Benha, Egypt.'}, {'ForeName': 'Ahmed E', 'Initials': 'AE', 'LastName': 'Elkafoury', 'Affiliation': 'Mahalla Cardiac Center, El Mahalla El Kubra, Egypt.'}, {'ForeName': 'Hany H', 'Initials': 'HH', 'LastName': 'Moussa', 'Affiliation': 'Kafr Elsheikh University, Faculty of Medicine, Chest Department, Benha, Egypt. Electronic address: hany_ahmed@med.kfs.edu.eg.'}]","Heart, lung & circulation",['10.1016/j.hlc.2019.09.014'] 3735,32369460,Assessment of tolerance and acceptability between mannitol solution and polyethylene glycol as bowel preparation for colonoscopy: a three-center study.,"INTRODUCTION Adequate bowel preparation is one of the most important factors related to the yield of colonoscopy. Lowquality bowel preparation has been associated with lower adenoma detection rates and increased healthcare expenses. Bowel preparation is a major impediment to undergo colonoscopy since it is perceived as an unpleasant experience by patients. OBJECTIVE This study was aimed to assess tolerance and acceptability of the bowel preparation using either polyethylene glycol (PEG) or mannitol solution. MATERIALS AND METHODS We enrolled 140 patients with indications of screening for colorectal cancer or with suspected large bowel diseases. They received either mannitol solution or PEG as bowel preparation. Patients were asked to fill a questionnaire about the bowel preparation experience. RESULTS Patients perceived more burdensome the preparation with PEG than mannitol for the variables nausea overall experience, post-procedure discomfort, disagreeable flavor, volume ingested and cost (p<0.05). A similar tolerance was reported for abdominal pain, bloating and anal irritation (p>0.05). The acceptability was 82.9% and 71.4% in the Mannitol group and in the PEG group, respectively (p=0.10). CONCLUSION Acceptance of the bowel preparation between mannitol solution and PEG was comparable. However, mannitol was better tolerated by the patients in regard to most of the evaluated items.",2020,"A similar tolerance was reported for abdominal pain, bloating and anal irritation (p>0.05).",['We enrolled 140 patients with indications of screening for colorectal cancer or with suspected large bowel diseases'],"['mannitol', 'mannitol solution and polyethylene glycol', 'Mannitol', 'polyethylene glycol (PEG) or mannitol solution', 'mannitol solution or PEG']","['nausea overall experience, post-procedure discomfort, disagreeable flavor, volume ingested and cost (p<0.05', 'acceptability', 'tolerated', 'abdominal pain, bloating and anal irritation', 'tolerance and acceptability']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0021851', 'cui_str': 'Structure of large intestine'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0024730', 'cui_str': 'Mannitol'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C1735348', 'cui_str': 'Anal irritation'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]",140.0,0.0129088,"A similar tolerance was reported for abdominal pain, bloating and anal irritation (p>0.05).","[{'ForeName': 'Jean Félix', 'Initials': 'JF', 'LastName': 'Piñ Erúa-Gonsá Lvez', 'Affiliation': 'Unit of Gastroenterology and Hepatology, Centro Clínico Andrés Bello. Ciudad Bolívar, Venezuela; Department of Endoscopy, Hospital de Clínicas Caracas. Caracas, Venezuela.'}, {'ForeName': 'Rosanna Del Carmen', 'Initials': 'RDC', 'LastName': 'Zambrano-Infantino', 'Affiliation': 'Unit of Gastroenterology and Hepatology, Centro Clínico Andrés Bello. Ciudad Bolívar, Venezuela; Department of Endoscopy, Hospital de Clínicas Caracas. Caracas, Venezuela.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Baptista', 'Affiliation': 'Department of Endoscopy, Hospital de Clínicas Caracas. Caracas, Venezuela.'}, {'ForeName': 'Mariseli', 'Initials': 'M', 'LastName': 'Sulbaran', 'Affiliation': 'Department of Gastroenterology, Hospital Militar ""Dr. Carlos Arvelo"". Caracas, Venezuela.'}, {'ForeName': 'Noheltriz', 'Initials': 'N', 'LastName': 'Camaray', 'Affiliation': 'Unit of Gastroenterology and Hepatology, Centro Clínico Andrés Bello. Ciudad Bolívar, Venezuela; Department of Internal Medicine, Hospital ""Dr. Hector Nouel Joubert"". Ciudad Bolívar, Venezuela.'}]",Revista de gastroenterologia del Peru : organo oficial de la Sociedad de Gastroenterologia del Peru,[] 3736,32348531,Optimizing DME Treatment With Decreased Injection Frequency Using Long-Term Steroid Implants.,"BACKGROUND AND OBJECTIVE Anti-vascular endothelial growth factor (VEGF) agents are the first-line treatment for diabetic macular edema (DME) based on randomized, control trials from the early 2000s. However, the efficacy of anti-VEGF is limited in clinical practice because its monthly injection schedule is logistically challenging for most working-age patients. PATIENTS AND METHODS Recent large-scale, randomized, control trials have demonstrated that intravitreal corticosteroid implants provide efficacious long-term treatment for DME. RESULTS Intravitreal corticosteroid implants block a wide spectrum of inflammatory factors involved in DME pathogenesis, with each implant lasting from months to years. Intravitreal corticosteroid implants also have the pharmacokinetic advantage over anti-VEGF agents in vitrectomized eyes. CONCLUSIONS Although anti-VEGF agents have lower bioavailability in vitrectomized eyes due to rapid clearance, intravitreal corticosteroid implants are not significantly affected by vitrectomy in bioavailability or efficacy. Side effects of intravitreal corticosteroid implants include cataract formation and ocular hypertension, both of which are manageable with appropriate monitoring. Taken together, intravitreal corticosteroid implants serve as a convenient, efficacious, and long-term treatment for patients with DME. [Ophthalmic Surg Lasers Imaging Retina. 2020;51:S22-S29.].",2020,"Side effects of intravitreal corticosteroid implants include cataract formation and ocular hypertension, both of which are manageable with appropriate monitoring.","['diabetic macular edema (DME', 'patients with DME']","['intravitreal corticosteroid implants', 'Anti-vascular endothelial growth factor (VEGF) agents']","['Injection Frequency', 'cataract formation and ocular hypertension']","[{'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0028840', 'cui_str': 'Ocular hypertension'}]",,0.0578439,"Side effects of intravitreal corticosteroid implants include cataract formation and ocular hypertension, both of which are manageable with appropriate monitoring.","[{'ForeName': 'Dimosthenis', 'Initials': 'D', 'LastName': 'Mantopoulos', 'Affiliation': ''}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Roth', 'Affiliation': ''}]","Ophthalmic surgery, lasers & imaging retina",['10.3928/23258160-20200401-03'] 3737,31257979,Descriptions of movement experiences in the Body Awareness Rating Scale - Movement Quality and Experience evaluation. A qualitative study of patients diagnosed with hip osteoarthritis.,"Background : Patients' access to movement experiences is implemented in the evaluation tool Body Awareness Rating Scale - Movement Quality and Experience, with its two intertwined parts: 1) the physiotherapist's observations of movement quality; and 2) the patient's descriptions of immediate movement experiences. Objective : To study movement experiences and reflections described by patients diagnosed with hip osteoarthritis when guided to explore simple daily-life movements in this particular evaluation context. Design : An explorative qualitative study with open-ended questions following each of the 12 movements integrated into the evaluation. Methods : 35 participants diagnosed with hip osteoarthritis were included; 28 women and 7 men, aged 23-78 years. Their descriptions were audiotaped, transcribed verbatim and analyzed in accordance with qualitative content analysis. Results : The patients described experiences of a dynamic adaptation of movement strategies based on sensations from the moving body. Two interrelated categories of movement awareness were identified: 1) Experienced movement challenges, including three sub-categories; a) Lack of contact , b) Movement changed by symptoms , and c) Compensational movement habits , and 2) Movement components promoting well-being, including three sub-categories; a) Integrating balance, breathing and awareness into movement , b) Small, simple, soft and safe movements , and c) A taste of own movement resources for daily life. Conclusions : The Body Awareness Rating Scale - Movement Quality and Experience provides a platform for patients to become aware of and describe their movement habits and resources in own words, intertwined with the physiotherapist movement observations. Derived descriptions reflect a patient perspective to be implemented in therapy.",2021,"The Body Awareness Rating Scale - Movement Quality and Experience provides a platform for patients to become aware of and describe their movement habits and resources in own words, intertwined with the physiotherapist movement observations.","['patients diagnosed with hip osteoarthritis', '35 participants diagnosed with hip osteoarthritis were included; 28 women and 7 men, aged 23-78 years']",[],"['Body Awareness Rating Scale - Movement Quality and Experience evaluation', 'Lack of contact , b) Movement changed by symptoms , and c) Compensational movement habits , and 2) Movement components promoting well-being, including three sub-categories; a) Integrating balance, breathing and awareness into movement , b) Small, simple, soft and safe movements , and c) A taste of own movement resources for daily life', 'Body Awareness Rating Scale - Movement Quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0029410', 'cui_str': 'Osteoarthritis of hip'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",35.0,0.0717568,"The Body Awareness Rating Scale - Movement Quality and Experience provides a platform for patients to become aware of and describe their movement habits and resources in own words, intertwined with the physiotherapist movement observations.","[{'ForeName': 'Aarid L', 'Initials': 'AL', 'LastName': 'Olsen', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Liv I', 'Initials': 'LI', 'LastName': 'Strand', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Liv H', 'Initials': 'LH', 'LastName': 'Magnussen', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Mary-Anne', 'Initials': 'MA', 'LastName': 'Sundal', 'Affiliation': 'Department of Health and Social Sciences, Western Norway University of Applied Sciences, Bergen, Norway.'}, {'ForeName': 'Liv H', 'Initials': 'LH', 'LastName': 'Skjaerven', 'Affiliation': 'Department of Health and Social Sciences, Western Norway University of Applied Sciences, Bergen, Norway.'}]",Physiotherapy theory and practice,['10.1080/09593985.2019.1636434'] 3738,33239632,The relationship between maternal dietary patterns during pregnancy in women with gestational diabetes mellitus and infant appetitive feeding behaviour at 6 months.,"Early dietary exposure may influence infant appetitive feeding behaviour, and therefore their later health. Maternal diabetes in pregnancy is associated with an increased risk of obesity in the offspring. We, therefore, examined third-trimester dietary patterns of women with gestational diabetes, their offspring's appetitive feeding behaviour at 6 months of age, and relationships between these. We used data from a prospective cohort of women with gestational diabetes and assessed maternal dietary patterns at 36 weeks' gestation using principal component analysis; infant appetitive feeding behaviour at 6 months of age using the Baby Eating Behaviour Questionnaire; and relationships between these using general linear modelling and chi-square tests. In 325 mother-infant dyads, we identified three distinct maternal dietary patterns: 'Junk,' 'Mixed,' and 'Health-conscious.' The maternal 'Health-conscious' pattern was inversely associated with 'enjoyment of food' in their sons (β - 0.24, 95% CI - 0.36 to - 0.11, p = 0.0003), but not daughters (β - 0.02, 95% CI - 0.12 to 0.08, p = 0.70), and was positively associated with 'slowness in eating,' (β 0.13, 95% CI 0.02 to 0.24, p = 0.01). Third-trimester dietary patterns in women with gestational diabetes may have sex-specific effects on infant appetitive feeding behaviour at 6 months of age.",2020,"The maternal 'Health-conscious' pattern was inversely associated with 'enjoyment of food' in their sons (β - 0.24, 95% CI - 0.36 to - 0.11, p = 0.0003), but not daughters (β - 0.02, 95% CI - 0.12 to 0.08, p = 0.70), and was positively associated with 'slowness in eating,' (β 0.13, 95% CI 0.02 to 0.24, p = 0.01).","[""325 mother-infant dyads, we identified three distinct maternal dietary patterns: 'Junk,' 'Mixed,' and 'Health-conscious"", 'women with gestational diabetes', ""women with gestational diabetes, their offspring's appetitive feeding behaviour at 6\xa0months of age, and relationships between these"", 'women with gestational diabetes mellitus and infant appetitive feeding behaviour at 6\xa0months', ""women with gestational diabetes and assessed maternal dietary patterns at 36\xa0weeks' gestation using principal component analysis; infant appetitive feeding behaviour at 6\xa0months of age using the Baby Eating Behaviour Questionnaire""]",[],"['enjoyment of food', 'Maternal diabetes']","[{'cui': 'C4517714', 'cui_str': '325'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205449', 'cui_str': '3'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0011892', 'cui_str': 'Heroin'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0039828', 'cui_str': 'Theses'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0429865', 'cui_str': 'Principal Component Analysis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",[],"[{'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}]",325.0,0.0358745,"The maternal 'Health-conscious' pattern was inversely associated with 'enjoyment of food' in their sons (β - 0.24, 95% CI - 0.36 to - 0.11, p = 0.0003), but not daughters (β - 0.02, 95% CI - 0.12 to 0.08, p = 0.70), and was positively associated with 'slowness in eating,' (β 0.13, 95% CI 0.02 to 0.24, p = 0.01).","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Amissah', 'Affiliation': 'Liggins Institute, University of Auckland, 85 Park Rd, Grafton, Auckland, 1023, New Zealand.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Gamble', 'Affiliation': 'Liggins Institute, University of Auckland, 85 Park Rd, Grafton, Auckland, 1023, New Zealand.'}, {'ForeName': 'Clare R', 'Initials': 'CR', 'LastName': 'Wall', 'Affiliation': 'Centre for Longitudinal Research-He Ara ki Mua, University of Auckland, Auckland, 1072, New Zealand.'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Crowther', 'Affiliation': 'Liggins Institute, University of Auckland, 85 Park Rd, Grafton, Auckland, 1023, New Zealand.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Harding', 'Affiliation': 'Liggins Institute, University of Auckland, 85 Park Rd, Grafton, Auckland, 1023, New Zealand. j.harding@auckland.ac.nz.'}]",Scientific reports,['10.1038/s41598-020-77388-1'] 3739,33138121,The Nutritional Impact of Milk Beverages in Reducing Nutrient Inadequacy among Children Aged One to Five Years in the Philippines: A Dietary Modelling Study.,"Around half of Filipino children are not consuming any dairy products on a given day, which has shown to be associated with increased risk of inadequate nutrient intakes. The current study applies dietary modelling to assess the nutritional impact of meeting dairy recommendations in reducing nutrient inadequacy in children aged one to five years in the Philippines. Dietary intake data of Filipino children aged one to five years ( n = 3864) were analyzed from the 8th National Nutrition Survey 2013. Children who did not meet national dairy recommendations were identified. Two scenarios were applied, based on two types of commonly consumed milk products by the survey participants. In scenario one, one serving of powdered milk was added to the diet of these children. In scenario two, one serving of a young children milk (YCM) or preschool children milk (PCM) was added to the diet of children aged one to two years and three to five years, respectively. Mean nutrient intakes and percentages of children with inadequate intakes were estimated before and after applying modelling scenarios. Scenario one demonstrated improvement in calcium, phosphorus, sodium, vitamin A and riboflavin intakes, while in scenario two, further improvement of intakes of a wider range of nutrients including iron, selenium, zinc, magnesium, potassium, vitamins C, D, E, thiamin, niacin, vitamins B6, and B12 was observed. In both scenarios, if all children would meet their dairy recommendations, theoretical reductions in population nutrient inadequacy would be observed for all micronutrients, for example, only 20% of children aged one to two years would be inadequate in vitamin A instead of the current 60%, iron inadequacy would see a 5% reduction, and approximately 10% reduction for calcium and 20% reduction for folate. The present study is the first to apply dietary modelling to assess the theoretical impact of meeting dairy recommendations on nutrient inadequacy in children in the Philippines. Dairy consumption should be encouraged as part of the strategy to reduce nutrient inadequacies. Calcium, iron, vitamins D, E, and folate are of concern in the Philippines as the level of inadequacies are extremely high in early years, YCM and PCM can help increase the intake of these nutrients.",2020,"Scenario one demonstrated improvement in calcium, phosphorus, sodium, vitamin A and riboflavin intakes, while in scenario two, further improvement of intakes of a wider range of nutrients including iron, selenium, zinc, magnesium, potassium, vitamins C, D, E, thiamin, niacin, vitamins B6, and B12 was observed.","['Children', 'children aged one to five years in the Philippines', 'children in the Philippines', 'Filipino children aged one to five years ( n = 3864) were analyzed from the 8th National Nutrition Survey 2013']",[],"['calcium, phosphorus, sodium, vitamin A and riboflavin intakes', 'Mean nutrient intakes and percentages of children with inadequate intakes', 'intakes of a wider range of nutrients including iron, selenium, zinc, magnesium, potassium, vitamins C, D, E, thiamin, niacin, vitamins B6, and B12', 'Calcium, iron, vitamins D, E, and folate']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1556093', 'cui_str': 'Filipinos'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0028713', 'cui_str': 'Nutritional Surveys'}]",[],"[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0035527', 'cui_str': 'Riboflavin'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0027996', 'cui_str': 'Niacin'}, {'cui': 'C0034272', 'cui_str': 'pyridoxine'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0178638', 'cui_str': 'Folate'}]",3864.0,0.0772888,"Scenario one demonstrated improvement in calcium, phosphorus, sodium, vitamin A and riboflavin intakes, while in scenario two, further improvement of intakes of a wider range of nutrients including iron, selenium, zinc, magnesium, potassium, vitamins C, D, E, thiamin, niacin, vitamins B6, and B12 was observed.","[{'ForeName': 'Tsz-Ning', 'Initials': 'TN', 'LastName': 'Mak', 'Affiliation': 'Nestlé Institute of Health Sciences, Nestlé Research, Route du Jorat 57, 1000 Lausanne, Switzerland.'}, {'ForeName': 'Imelda', 'Initials': 'I', 'LastName': 'Angeles-Agdeppa', 'Affiliation': 'Department of Science and Technology-Food and Nutrition Research Institute, Taguig City 1631, Philippines.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Tassy', 'Affiliation': 'Nestlé Institute of Health Sciences, Nestlé Research, Route du Jorat 57, 1000 Lausanne, Switzerland.'}, {'ForeName': 'Mario V', 'Initials': 'MV', 'LastName': 'Capanzana', 'Affiliation': 'Department of Science and Technology-Food and Nutrition Research Institute, Taguig City 1631, Philippines.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Offord', 'Affiliation': 'Nestlé Institute of Health Sciences, Nestlé Research, Route du Jorat 57, 1000 Lausanne, Switzerland.'}]",Nutrients,['10.3390/nu12113330'] 3740,32685540,Measurement Invariance and Psychometric Analysis of Oxford Happiness Inventory Scale across Gender and Marital Status.,"Background The Oxford Happiness Inventory (OHI) is a self-report tool to measure happiness. A brief review of previous studies on OHI showed the lack of evaluation of OHI fairness/equivalence in measuring happiness among identified groups. Methods To examine the psychometric properties and measurement invariance of the OHI, responses of 500 university students were analyzed using item response theory and ordinal logistic regression (OLR). Relevant measures of effect size were utilized to interpret the results. Differential test functioning was also evaluated to determine whether there is an overall bias at the test level. Results OLR analysis detected four items across gender and two items across marital status to function differentially. An assessment of effect sizes implied negligible differences for practical considerations. Conclusions This study was a significant step towards providing theoretical and practical information regarding the assessment of happiness by presenting adequate evidence regarding the psychometric properties of OHI.",2020,"To examine the psychometric properties and measurement invariance of the OHI, responses of 500 university students were analyzed using item response theory and ordinal logistic regression (OLR).",['500 university students'],[],['Measurement Invariance and Psychometric Analysis of Oxford Happiness Inventory Scale across Gender and Marital Status'],"[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",[],"[{'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0024819', 'cui_str': 'Marital status'}]",,0.073416,"To examine the psychometric properties and measurement invariance of the OHI, responses of 500 university students were analyzed using item response theory and ordinal logistic regression (OLR).","[{'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Mousavi', 'Affiliation': 'Department of Educational Psychology and Special Education, College of Education, University of Saskatchewan, Canada.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Sharafi', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Health, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Abdolreza', 'Initials': 'A', 'LastName': 'Mahmoudi', 'Affiliation': 'Department of Islamic Education, Faculty of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Hadi Raeisi', 'Initials': 'HR', 'LastName': 'Shahraki', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Health, Shahrekord University of Medical Sciences, Shahrekord, Iran.'}]",BioMed research international,['10.1155/2020/8906209'] 3741,33854572,Reduction of anterior uveitis flares in patients with axial spondyloarthritis on certolizumab pegol treatment: final 2-year results from the multicenter phase IV C-VIEW study.,"Introduction Acute anterior uveitis (AAU), affecting up to 40% of patients with axial spondyloarthritis (axSpA), risks permanent visual deficits if not adequately treated. We report 2-year results from C-VIEW, the first study to prospectively investigate certolizumab pegol (CZP) on AAU in patients with active axSpA at high risk of recurrent AAU. Patients and methods C-VIEW (NCT03020992) was a 104-week (96 weeks plus 8-week safety follow-up), open-label, multicenter study. Eligible patients had active axSpA, human leukocyte antigen-B27 (HLA-B27) positivity and a history of recurrent AAU (⩾2 AAU flares in total; ⩾1 in the year prior to baseline). Patients received CZP 400 mg at weeks 0, 2 and 4, then 200 mg every 2 weeks to week 96. The primary efficacy endpoint was the AAU flare event rate during 96 weeks' CZP versus 2 years pre-baseline. Results Of 115 enrolled patients, 89 initiated CZP (male: 63%; radiographic/non-radiographic axSpA: 85%/15%; mean disease duration: 9.1 years); 83 completed week 96. There was a significant 82% reduction in AAU flare event rate during CZP versus pre-baseline [rate ratio (95% confidence interval): 0.18 (0.12-0.28), p  < 0.001]. One hundred percent and 59.6% of patients experienced ⩾1 and ⩾2 AAU flares pre-baseline, respectively, compared to 20.2% and 11.2% during treatment. Age, sex and axSpA population subgroup analyses were consistent with the primary analysis. There were substantial improvements in axSpA disease activity with no new safety signal identified. Conclusion CZP treatment significantly reduced AAU flare event rate in patients with axSpA and a history of AAU, indicating CZP is a suitable treatment option for patients at risk of recurrent AAU. Trial Registration ClinicalTrialsgov NCT03020992, URL: https://clinicaltrials.gov/ct2/show/NCT03020992.",2021,"There was a significant 82% reduction in AAU flare event rate during CZP versus pre-baseline [rate ratio (95% confidence interval): 0.18 (0.12-0.28), p  < 0.001].","['patients with active axSpA at high risk of recurrent AAU', '115 enrolled patients, 89 initiated CZP (male', 'Eligible patients had active axSpA, human leukocyte antigen-B27 (HLA-B27) positivity and a history of recurrent AAU (⩾2 AAU flares in total; ⩾1 in the year prior to baseline', 'patients with axial spondyloarthritis on certolizumab pegol treatment', 'mean disease duration: 9.1\u2009years); 83 completed week 96']","['certolizumab pegol (CZP', 'CZP', 'URL']","['AAU flare event rate', 'anterior uveitis flares']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0439589', 'cui_str': 'Recurrent acute'}, {'cui': 'C0042165', 'cui_str': 'Anterior uveitis'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C1872109', 'cui_str': 'certolizumab pegol'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0019740', 'cui_str': 'HLA-B27 antigen'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0701807', 'cui_str': 'Acute anterior uveitis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C1872109', 'cui_str': 'certolizumab pegol'}, {'cui': 'C3541384', 'cui_str': 'URL'}]","[{'cui': 'C0701807', 'cui_str': 'Acute anterior uveitis'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0042165', 'cui_str': 'Anterior uveitis'}]",115.0,0.174258,"There was a significant 82% reduction in AAU flare event rate during CZP versus pre-baseline [rate ratio (95% confidence interval): 0.18 (0.12-0.28), p  < 0.001].","[{'ForeName': 'Irene E', 'Initials': 'IE', 'LastName': 'van der Horst-Bruinsma', 'Affiliation': 'Department of Rheumatology, Amsterdam University Medical Center, Location VU Medical Center, De Boelelaan 1117, Amsterdam, 1081 HV, The Netherlands.'}, {'ForeName': 'Rianne E', 'Initials': 'RE', 'LastName': 'van Bentum', 'Affiliation': 'Department of Rheumatology, Amsterdam University Medical Centers, Location VU Medical Centre, Amsterdam, The Netherlands.'}, {'ForeName': 'Frank D', 'Initials': 'FD', 'LastName': 'Verbraak', 'Affiliation': 'Department of Ophthalmology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Deodhar', 'Affiliation': 'Division of Arthritis and Rheumatic Diseases, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rath', 'Affiliation': 'Department of Opthalmology, St Franziskus-Hospital, Münster, Germany.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Hoepken', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Irvin-Sellers', 'Affiliation': 'UCB Pharma, Slough, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Thomas', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bauer', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Rudwaleit', 'Affiliation': 'Clinic for Internal Medicine and Rheumatology, Klinikum Bielefeld and Department of Gastroenterology, Infectiology and Rheumatology, Charité Berlin, Germany.'}]",Therapeutic advances in musculoskeletal disease,['10.1177/1759720X211003803'] 3742,33854561,"Efficacy and Safety of Ningmitai Capsules in Patients with Chronic Epididymitis: A Prospective, Parallel Randomized Controlled Clinical Trial.","Objectives To evaluate the efficacy and safety of Ningmitai (NMT) capsules in patients with chronic epididymitis. Methods This prospective randomized controlled trial included 112 patients diagnosed with chronic epididymitis. The patients were randomized (1 : 1 : 1) to receive levofloxacin (LVX), NMT, or NMT combined with LVX for 4 weeks. The patients were followed up at 2 and 4 weeks after initiation of treatment and were evaluated in terms of Chronic Epididymitis Symptom Index (CESI) scores, epididymal nodules, and safety parameters. The primary endpoints were the CESI scores at the end of 2 and 4 weeks of treatment. The secondary endpoints included the mean epididymal nodule diameter and the clinical efficacy rate. Safety was evaluated by hepatorenal function tests and adverse event reports during the trial. Results After 2 weeks of treatment, the CESI score of the NMT group was significantly lower than that of the LVX group ( P < 0.05). In addition, the clinical efficacy rate of the NMT group was significantly higher than that of the LVX group (55% vs. 8.33%, P < 0.0001), indicating that NMT has a rapid effect on chronic epididymitis. After 4 weeks of treatment, there was no significant difference in CESI scores or clinical efficacy rates between the two monotherapy regimens ( P > 0.05); however, the mean diameter of epididymal nodules was significantly smaller in the NMT group than in the LVX group ( P < 0.0001). Moreover, after 4 weeks of treatment, the patients in the LVX + NMT group, which had a clinical efficacy rate of 97.22%, had lower CESI scores (both P < 0.01) and a smaller epididymal nodule diameter (vs. LVX, P < 0.0001; vs. NMT, P < 0.05) than those in the other two groups. No adverse events or abnormal hepatorenal function were found during the study. Conclusion NMT significantly improved CESI scores and epididymal nodule diameter in patients with chronic epididymitis. The combination of NMT and LVX provides a much better effect than monotherapy, and this treatment regimen was well tolerated.",2021,"After 4 weeks of treatment, there was no significant difference in CESI scores or clinical efficacy rates between the two monotherapy regimens ( P > 0.05); however, the mean diameter of epididymal nodules was significantly smaller in the NMT group than in the LVX group ( P < 0.0001).","['patients with chronic epididymitis', 'Patients with Chronic Epididymitis', '112 patients diagnosed with chronic epididymitis']","['LVX', 'NMT', 'levofloxacin (LVX), NMT, or NMT combined with LVX', 'Ningmitai (NMT) capsules', 'Ningmitai Capsules', 'NMT and LVX']","['tolerated', 'CESI scores', 'Efficacy and Safety', 'CESI scores or clinical efficacy rates', 'Chronic Epididymitis Symptom Index (CESI) scores, epididymal nodules, and safety parameters', 'efficacy and safety', 'mean diameter of epididymal nodules', 'CESI scores and epididymal nodule diameter', 'CESI score', 'clinical efficacy rate', 'mean epididymal nodule diameter and the clinical efficacy rate', 'lower CESI scores', 'smaller epididymal nodule diameter', 'adverse events or abnormal hepatorenal function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0014533', 'cui_str': 'Epididymis structure'}, {'cui': 'C0028259', 'cui_str': 'Nodule'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",112.0,0.0534219,"After 4 weeks of treatment, there was no significant difference in CESI scores or clinical efficacy rates between the two monotherapy regimens ( P > 0.05); however, the mean diameter of epididymal nodules was significantly smaller in the NMT group than in the LVX group ( P < 0.0001).","[{'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Jing', 'Affiliation': 'Department of Nephrology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, Shandong, China.'}, {'ForeName': 'Guan', 'Initials': 'G', 'LastName': 'Liying', 'Affiliation': 'Physical Examination Center, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, Shandong, China.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Zhenqing', 'Affiliation': 'Department of Urology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, Shandong, China.'}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Hui', 'Affiliation': 'Department of Urology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, Shandong, China.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Shuai', 'Affiliation': 'Department of Urology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, Shandong, China.'}, {'ForeName': 'Sun', 'Initials': 'S', 'LastName': 'Dingqi', 'Affiliation': 'Department of Urology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, Shandong, China.'}, {'ForeName': 'Fu', 'Initials': 'F', 'LastName': 'Qiang', 'Affiliation': 'Department of Urology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, Shandong, China.'}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Keqin', 'Affiliation': 'Department of Urology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, Shandong, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2021/9752592'] 3743,33854559,The Efficacy of Plantago major Seed on Liver Enzymes in Nonalcoholic Fatty Liver Disease: A Randomized Double-Blind Clinical Trial.,"Objective This study aims to evaluate the effects of Plantago major ( P. major ) seed on liver enzymes and ultrasound patterns in nonalcoholic fatty liver disease (NAFLD). Design In this randomized double-blind placebo-controlled clinical trial, 74 patients with NAFLD were administered either 2 g P. major or placebo twice daily for 12 weeks. All patients were advised to follow the recommendations for daily exercise and diet modification. Levels of liver enzymes as well as other laboratory indexes were measured at the beginning of the study and after 12 weeks. Indeed, the alteration in ultrasound grade was evaluated in NAFLD patients. Results Sixty-three participants completed the study in the intervention and control groups. The mean age of participants was 43.3 (±8.927) and 38.7 (±8.48) years in the intervention and control groups, respectively. P. major group showed significant reduction in alanine aminotransferase (ALT) (47.32 ± 21.77 IU/L vs. 50.03 ± 21.19, P  = 0.021), aspartate aminotransferase (AST) (28.29 ± 10.49 IU/L vs. 32.03 ± 13.30, P  = 0.004), triglyceride (TG) (200.93 ± 106.741 mg/dl vs. 183.75 ± 73.96, P  = 0.001), waist circumference (WC) (101.25 ± 9.27 cm vs. 101.18 ± 8.63, P  = 0.027), and grade of fatty liver in ultrasonography ( P  = 0.038), comparing to the placebo group. There was no significant difference between the two groups regarding serum levels of fasting blood sugar (FBS), high-density lipoprotein (HDL), low-density lipoprotein (LDL), cholesterol, and other outcomes. Conclusion P. major supplementation with a daily dose of 2 g for 12 weeks improved serum levels of ALT, AST, and TG in patients with NAFLD. Further studies with a larger sample size are recommended.",2021,"P. major group showed significant reduction in alanine aminotransferase (ALT) (47.32 ± 21.77 IU/L vs. 50.03 ± 21.19, P  = 0.021), aspartate aminotransferase (AST) (28.29 ± 10.49 IU/L vs. 32.03 ± 13.30, P  = 0.004), triglyceride (TG) (200.93 ± 106.741 mg/dl vs. 183.75 ± 73.96, P  = 0.001), waist circumference (WC) (101.25 ± 9.27 cm vs. 101.18 ± 8.63, P  = 0.027), and grade of fatty liver in ultrasonography ( P  = 0.038), comparing to the placebo group.","['74 patients with NAFLD', 'patients with NAFLD', 'Nonalcoholic Fatty Liver Disease', 'nonalcoholic fatty liver disease (NAFLD', 'The mean age of participants was 43.3 (±8.927) and 38.7 (±8.48) years in the intervention and control groups, respectively']","['Plantago major Seed', 'Plantago major ( P. major ) seed', 'placebo', '2\u2009g P. major or placebo']","['alanine aminotransferase (ALT', 'serum levels of ALT, AST, and TG', 'triglyceride (TG', 'waist circumference (WC', 'grade of fatty liver in ultrasonography', 'serum levels of fasting blood sugar (FBS), high-density lipoprotein (HDL), low-density lipoprotein (LDL), cholesterol, and other outcomes', 'Levels of liver enzymes', 'aspartate aminotransferase (AST']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3485015', 'cui_str': 'Plantago major seed extract'}, {'cui': 'C3488573', 'cui_str': 'Plantago major extract'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}]",74.0,0.416508,"P. major group showed significant reduction in alanine aminotransferase (ALT) (47.32 ± 21.77 IU/L vs. 50.03 ± 21.19, P  = 0.021), aspartate aminotransferase (AST) (28.29 ± 10.49 IU/L vs. 32.03 ± 13.30, P  = 0.004), triglyceride (TG) (200.93 ± 106.741 mg/dl vs. 183.75 ± 73.96, P  = 0.001), waist circumference (WC) (101.25 ± 9.27 cm vs. 101.18 ± 8.63, P  = 0.027), and grade of fatty liver in ultrasonography ( P  = 0.038), comparing to the placebo group.","[{'ForeName': 'Seyedeh Ferdows', 'Initials': 'SF', 'LastName': 'Jazayeri', 'Affiliation': 'Research Institute for Islamic and Complementary Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Roshanak', 'Initials': 'R', 'LastName': 'Ghods', 'Affiliation': 'Research Institute for Islamic and Complementary Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fataneh', 'Initials': 'F', 'LastName': 'Hashem Dabaghian', 'Affiliation': 'Research Institute for Islamic and Complementary Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Asie', 'Initials': 'A', 'LastName': 'Shojaii', 'Affiliation': 'Research Institute for Islamic and Complementary Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Ali Al-Hadi', 'Initials': 'SAA', 'LastName': 'Moravej', 'Affiliation': 'Research Institute for Islamic and Complementary Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Khadem', 'Affiliation': 'Department of Traditional Medicine, School of Traditional Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Saeed', 'Initials': 'SS', 'LastName': 'Seyedian', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2021/6693887'] 3744,33854484,Cardiovascular Safety and Benefits of Semaglutide in Patients With Type 2 Diabetes: Findings From SUSTAIN 6 and PIONEER 6.,"To exclude an excess risk of cardiovascular (CV) events, CV outcomes trials (CVOTs) have assessed the effects of new glucose-lowering therapies, including glucagon-like peptide-1 receptor agonists (GLP-1RAs), in patients with type 2 diabetes and established CV disease or CV risk factors. The CV safety of semaglutide vs. placebo, when added to standard care, was evaluated in the SUSTAIN 6 trial for the formulation administered once-weekly subcutaneously and in PIONEER 6 for the new once-daily oral formulation. In SUSTAIN 6 and PIONEER 6, both powered to demonstrate noninferiority (upper 95% confidence interval [CI] of the hazard ratio [HR] <1.8), there were fewer first major adverse CV events with semaglutide vs. placebo, with HRs of 0.74 (95% CI 0.58-0.95) and 0.79 (0.57-1.11), respectively. In SUSTAIN 6, the results were significant for noninferiority and superiority, although the latter was not prespecified. Surprisingly, CV and all-cause mortality were significantly reduced by oral semaglutide in PIONEER 6. The ongoing SOUL CVOT will further inform about CV outcomes with oral semaglutide vs. placebo (NCT03914326). Findings from SUSTAIN 6 and PIONEER 6 fall within the spectrum reported with other GLP-1RA CVOTs: noninferiority vs. placebo for major CV events was seen with lixisenatide and exenatide extended-release, while superiority was demonstrated with liraglutide, albiglutide, and dulaglutide. Beneficial outcomes have been recognized in international guidelines, which recommend subcutaneous liraglutide, semaglutide, and dulaglutide to reduce the risk of CV events in high-risk patients. Both indirect mechanisms via risk factor modification and direct effects via GLP-1 receptors in the CV system have been proposed to be responsible for CV event reductions. The exact mechanism(s) remains to be characterized, but appears to be mainly linked to anti-atherosclerotic effects. Further research is needed to elucidate the relevant mechanisms for CV benefits of GLP-1RAs.",2021,"In SUSTAIN 6 and PIONEER 6, both powered to demonstrate noninferiority (upper 95% confidence interval [CI] of the hazard ratio [HR] <1.8), there were fewer first major adverse CV events with semaglutide vs. placebo, with HRs of 0.74 (95% CI 0.58-0.95) and 0.79 (0.57-1.11), respectively.","['Patients With Type 2 Diabetes', 'patients with type 2 diabetes and established CV disease or CV risk factors']","['placebo', 'semaglutide vs. placebo', 'Semaglutide']","['CV safety', 'Cardiovascular Safety', 'adverse CV events', 'CV and all-cause mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.348426,"In SUSTAIN 6 and PIONEER 6, both powered to demonstrate noninferiority (upper 95% confidence interval [CI] of the hazard ratio [HR] <1.8), there were fewer first major adverse CV events with semaglutide vs. placebo, with HRs of 0.74 (95% CI 0.58-0.95) and 0.79 (0.57-1.11), respectively.","[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nauck', 'Affiliation': 'Diabetes Division, Katholisches Kinikum Bochum, St. Josef-Hospital, Ruhr-University of Bochum, Bochum, Germany.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Quast', 'Affiliation': 'Diabetes Division, Katholisches Kinikum Bochum, St. Josef-Hospital, Ruhr-University of Bochum, Bochum, Germany.'}]",Frontiers in endocrinology,['10.3389/fendo.2021.645566'] 3745,33854466,"A Self-Applied Multi-Component Psychological Online Intervention Based on UX, for the Prevention of Complicated Grief Disorder in the Mexican Population During the COVID-19 Outbreak: Protocol of a Randomized Clinical Trial.","Background: COVID-19 has taken many lives worldwide and due to this, millions of persons are in grief. When the grief process lasts longer than 6 months, the person is in risk of developing Complicated Grief Disorder (CGD). The CGD is related to serious health consequences. To reduce the probability of developing CGD a preventive intervention could be applied. In developing countries like Mexico, the psychological services are scarce, self-applied interventions could provide support to solve this problem and reduce the health impact even after the pandemic has already finished. Aims: To design and implement a self-applied intervention composed of 12 modules focused on the decrease of the risk of developing CGD, and increasing the life quality, and as a secondary objective to reduce the symptomatology of anxiety, depression, and increase of sleep quality. The Intervention Duelo COVID (Grief COVID) follows the principles of User Experience (UX) and is designed according to the needs and desires of a sample of the objective participants, to increase the adherence to the self-applied intervention, considered one of the main weaknesses of online interventions. Methods: A Randomized Controlled Trial will be conducted from the 22nd of December of 2020 to the first of June 2021. The participants will be assigned to an intervention with elements of Cognitive Behavioral Therapy, Acceptance and Commitment Therapy, Mindfulness and Positive Psychology. The control group will be a wait-list condition, that will receive the intervention 1.5-2 months after the pre-measurement were taken. The Power Size Calculation conducted through G * Power indicated the need for a total of 42 participants, which will be divided by 21 participants in each group. The platform will be delivered through responsive design assuring with this that the intervention will adapt to the screen size of cellphones, tablets, and computers. Ethics and Dissemination: The study counts with the approval of the Research Ethics Committee of the Autonomous University of Ciudad Juárez, México, and it is registered in Clinical Trials (NCT04638842). The article is sent and registered in clinical trials before the recruitment started. The results will be reported in future conferences, scientific publications, and media.",2021,"To design and implement a self-applied intervention composed of 12 modules focused on the decrease of the risk of developing CGD, and increasing the life quality, and as a secondary objective to reduce the symptomatology of anxiety, depression, and increase of sleep quality.",['22nd of December of 2020 to the first of June 2021'],"['Cognitive Behavioral Therapy, Acceptance and Commitment Therapy, Mindfulness and Positive Psychology', 'Self-Applied Multi-Component Psychological Online Intervention']","['symptomatology of anxiety, depression, and increase of sleep quality']",[],"[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",42.0,0.182299,"To design and implement a self-applied intervention composed of 12 modules focused on the decrease of the risk of developing CGD, and increasing the life quality, and as a secondary objective to reduce the symptomatology of anxiety, depression, and increase of sleep quality.","[{'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Dominguez-Rodriguez', 'Affiliation': 'Health Sciences Area, Valencian International University, Valencia, Spain.'}, {'ForeName': 'Sofia Cristina', 'Initials': 'SC', 'LastName': 'Martínez-Luna', 'Affiliation': 'Facultad de Psicología, Universidad Nacional Autónoma de México, Mexico City, Mexico.'}, {'ForeName': 'María Jesús', 'Initials': 'MJ', 'LastName': 'Hernández Jiménez', 'Affiliation': 'Health Sciences Area, Valencian International University, Valencia, Spain.'}, {'ForeName': 'Anabel', 'Initials': 'A', 'LastName': 'De La Rosa-Gómez', 'Affiliation': 'Iztacala College of Higher Education, National Autonomous University of Mexico, Mexico City, Mexico.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Arenas-Landgrave', 'Affiliation': 'Facultad de Psicología, Universidad Nacional Autónoma de México, Mexico City, Mexico.'}, {'ForeName': 'Esteban Eugenio', 'Initials': 'EE', 'LastName': 'Esquivel Santoveña', 'Affiliation': 'Department of Social Sciences, Universidad Autónoma de Ciudad Juárez, Ciudad Juárez, Mexico.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Arzola-Sánchez', 'Affiliation': 'Department of Social Sciences, Universidad Autónoma de Ciudad Juárez, Ciudad Juárez, Mexico.'}, {'ForeName': 'Joabián', 'Initials': 'J', 'LastName': 'Alvarez Silva', 'Affiliation': 'Independent Researcher, Ciudad Juárez, Mexico.'}, {'ForeName': 'Arantza Mariel', 'Initials': 'AM', 'LastName': 'Solis Nicolas', 'Affiliation': 'Independent Researcher, Tijuana, Mexico.'}, {'ForeName': 'Ana Marisa', 'Initials': 'AM', 'LastName': 'Colmenero Guadián', 'Affiliation': 'Independent Researcher, Ciudad Juárez, Mexico.'}, {'ForeName': 'Flor Rocio', 'Initials': 'FR', 'LastName': 'Ramírez-Martínez', 'Affiliation': 'Department of Social Sciences, Universidad Autónoma de Ciudad Juárez, Ciudad Juárez, Mexico.'}, {'ForeName': 'Rosa Olimpia Castellanos', 'Initials': 'ROC', 'LastName': 'Vargas', 'Affiliation': 'Department of Social Sciences, Universidad Autónoma de Ciudad Juárez, Ciudad Juárez, Mexico.'}]",Frontiers in psychology,['10.3389/fpsyg.2021.644782'] 3746,33854457,A Cognitive-Emotional Model to Explain Message Framing Effects: Reducing Meat Consumption.,"We tested the plausibility of a cognitive-emotional model to understand the effects of messages framed in terms of gain, non-loss, non-gain, and loss, and related to the health consequences of red/processed meat consumption. A total of 544 Italian participants reported their attitude toward reduced red/processed meat consumption and intention to eat red/processed meat (time 1 questionnaire). One week later, participants were randomly assigned to four different message conditions: (a) gain messages focused on the positive health outcomes associated with low meat consumption; (b) non-loss messages focused on the avoided negative health outcomes associated with low meat consumption; (c) non-gain messages focused on the missed positive health outcomes associated with high meat consumption; (d) loss messages focused on the negative health outcomes associated with high meat consumption (message sending). After reading the messages, participants answered a series of questions regarding their emotional and cognitive reactions to the messages, their evaluation of the messages, and again their attitude and intention toward red/processed meat consumption (time 2 questionnaire). Comparing different multivariate linear models under the Bayesian approach, we selected the model with the highest plausibility conditioned to observed data. In this model, message-induced fear influenced systematic processing, which in turn positively influenced message evaluation and attitude, leading to reduced intention to consume red/processed meat. Vice versa, message-induced anger reduced systematic processing, which in turn negatively influenced message evaluation, and led to no effect on attitude and intention. The comparison among message conditions showed that gain and non-loss messages activated integrated emotional and cognitive processing of the health recommendation, while loss and non-gain messages mainly activated emotional shortcuts toward attitude and intention. Overall, these results advance our comprehension of the effects of message framing on receivers' attitudes and intentions.",2021,"The comparison among message conditions showed that gain and non-loss messages activated integrated emotional and cognitive processing of the health recommendation, while loss and non-gain messages mainly activated emotional shortcuts toward attitude and intention.",['544 Italian participants'],['message conditions: (a) gain messages focused on the positive health outcomes associated with low meat consumption; (b) non-loss messages focused on the avoided negative health outcomes associated with low meat consumption; (c) non-gain messages focused on the missed positive health outcomes associated with high meat consumption; (d) loss messages focused on the negative health outcomes associated with high meat consumption (message sending'],"['Reducing Meat Consumption', 'attitude toward reduced red/processed meat consumption and intention to eat red/processed meat (time 1 questionnaire']","[{'cui': 'C0022275', 'cui_str': 'Italian language'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0452956', 'cui_str': 'Processed meat'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",544.0,0.0355071,"The comparison among message conditions showed that gain and non-loss messages activated integrated emotional and cognitive processing of the health recommendation, while loss and non-gain messages mainly activated emotional shortcuts toward attitude and intention.","[{'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Carfora', 'Affiliation': 'Department of Psychology, Catholic University of the Sacred Heart, Milan, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Pastore', 'Affiliation': 'Department of Developmental and Social Psychology, University of Padua, Padua, Italy.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Catellani', 'Affiliation': 'Department of Psychology, Catholic University of the Sacred Heart, Milan, Italy.'}]",Frontiers in psychology,['10.3389/fpsyg.2021.583209'] 3747,33854439,"The Effect of Quadriceps Muscle Length on Maximum Neuromuscular Electrical Stimulation Evoked Contraction, Muscle Architecture, and Tendon-Aponeurosis Stiffness.","Muscle-tendon unit length plays a crucial role in quadriceps femoris muscle (QF) physiological adaptation, but the influence of hip and knee angles during QF neuromuscular electrical stimulation (NMES) is poorly investigated. We investigated the effect of muscle length on maximum electrically induced contraction (MEIC) and current efficiency. We secondarily assessed the architecture of all QF constituents and their tendon-aponeurosis complex (TAC) displacement to calculate a stiffness index. This study was a randomized, repeated measure, blinded design with a sample of twenty healthy men aged 24.0 ± 4.6. The MEIC was assessed in four different positions: supine with knee flexion of 60° (SUP60); seated with knee flexion of 60° (SIT60); supine with knee flexion of 20° (SUP20), and seated with knee flexion of 20° (SIT20). The current efficiency (MEIC/maximum tolerated current amplitude) was calculated. Ultrasonography of the QF was performed at rest and during NMES to measure pennation angle (θ p ) and fascicle length ( L f ), and the TAC stiffness index. MEIC and current efficiency were greater for SUP60 and SIT60 compared to SUP20 and SIT20. The vastus lateralis and medialis showed lower θ p and higher L f at SUP60 and SIT60, while for the rectus femoris, in SUP60 there were lower θ p and higher L f than in all positions. The vastus intermedius had a similar pattern to the other vastii, except for lack of difference in θ p between SIT60 compared to SUP20 and SIT20. The TAC stiffness index was greater for SUP60. We concluded that NMES generate greater torque and current efficiency at 60° of knee flexion, compared to 20°. For these knee angles, lengthening the QF at the hip did not promote significant change. Each QF constituent demonstrated muscle physiology patterns according to hip and/or knee angles, even though a greater L f and lower θ p were predominant in SUP60 and SIT60. QF TAC index stiffened in more elongated positions, which probably contributed to enhanced force transmission and slightly higher torque in SUP60. Our findings may help exercise physiologist better understand the impact of hip and knee angles on designing more rational NMES stimulation strategies. Clinical Trial Registration www.ClinicalTrials.gov, identifier NCT03822221.",2021,"The vastus intermedius had a similar pattern to the other vastii, except for lack of difference in θ p between SIT60 compared to SUP20 and SIT20.",['twenty healthy men aged 24.0 ± 4.6'],"['NMES', 'supine with knee flexion of 60° (SUP60); seated with knee flexion of 60° (SIT60); supine with knee flexion of 20° (SUP20), and seated with knee flexion of 20° (SIT20', 'Quadriceps Muscle Length', 'QF neuromuscular electrical stimulation (NMES']","['QF TAC index', 'TAC stiffness index', 'torque and current efficiency', 'MEIC and current efficiency', 'contraction (MEIC) and current efficiency', 'θ p and higher L']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517764', 'cui_str': '4.6'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1444754', 'cui_str': 'Length'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0225205', 'cui_str': 'Aponeurosis structure'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0205250', 'cui_str': 'High'}]",20.0,0.0513654,"The vastus intermedius had a similar pattern to the other vastii, except for lack of difference in θ p between SIT60 compared to SUP20 and SIT20.","[{'ForeName': 'Jonathan Galvão Tenório', 'Initials': 'JGT', 'LastName': 'Cavalcante', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Faculdade de Ceilândia, Centro Metropolitano, Universidade de Brasília, Brasília, Brazil.'}, {'ForeName': 'Rita de Cassia', 'Initials': 'RC', 'LastName': 'Marqueti', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Faculdade de Ceilândia, Centro Metropolitano, Universidade de Brasília, Brasília, Brazil.'}, {'ForeName': 'Jeam Marcel', 'Initials': 'JM', 'LastName': 'Geremia', 'Affiliation': 'Laboratório de Pesquisa do Exercício, Escola de Educação Física, Fisioterapia e Dança, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Ivo Vieira', 'Initials': 'IV', 'LastName': 'de Sousa Neto', 'Affiliation': 'Graduate Program in Sciences and Technology in Health, Faculdade de Ceilândia, Centro Metropolitano, Universidade de Brasília, Brasília, Brazil.'}, {'ForeName': 'Bruno Manfredini', 'Initials': 'BM', 'LastName': 'Baroni', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Karin Gravare', 'Initials': 'KG', 'LastName': 'Silbernagel', 'Affiliation': 'Department of Physical Therapy, University of Delaware, Newark, DE, United States.'}, {'ForeName': 'Martim', 'Initials': 'M', 'LastName': 'Bottaro', 'Affiliation': 'Departamento de Educação Física, Faculdade de Educação Física, Universidade de Brasília, Brasília, Brazil.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Babault', 'Affiliation': 'Unité Cognition, Action, et Plasticité Sensorimotrice, Faculté des Sciences du Sport, Université Bourgogne, Dijon, France.'}, {'ForeName': 'João Luiz Quagliotti', 'Initials': 'JLQ', 'LastName': 'Durigan', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Faculdade de Ceilândia, Centro Metropolitano, Universidade de Brasília, Brasília, Brazil.'}]",Frontiers in physiology,['10.3389/fphys.2021.633589'] 3748,33854309,Adherence to Treatment Recommendations for Chronic Obstructive Pulmonary Disease - Results from the Swedish National Airway Register.,"Introduction Swedish guidelines adhere to the international GOLD document regarding management of chronic obstructive pulmonary disease (COPD). Based on data from the Swedish National Airway Register (SNAR) the aim was to evaluate adherence to guidelines of pharmacological treatment of COPD in Swedish primary and secondary care. Methods During a period of 18 months, data on symptoms (CAT, mMRC), lung function, exacerbation history and pharmacological treatment from 15,595 COPD patients from 853 primary care and 125 secondary care clinics were collected from SNAR. Patients with a co-diagnosis of asthma were excluded. Patients were divided into four treatment groups: no pharmacological treatment, short-acting bronchodilators alone, long-acting bronchodilators alone and ICS alone or in combination with bronchodilators. Results Of the patients, 29% were in GOLD group A, 58% in group B, 2% in group C and 11% in group D. CAT score was ≥10 and mMRC score was below 2 in 30.9% of the patients and mMRC score was ≥2 and CAT score <10 in 4.2% of the patients. In 61.4% of the patients, no exacerbation was registered during the last year. Long-acting bronchodilators were prescribed for 78% and ICS for 46% of all patients. In groups A, B, C and D, respectively, 21%, 11%, 11% and 5% did not receive any inhaler therapy; 67%, 81%, 81% and 90% received long-acting bronchodilators; 33%, 46%, 55% and 71% received any ICS containing therapy and 19%, 34%, 39% and 61% received triple therapy. Discussion Data from the SNAR indicate that only a minority of COPD patients were untreated. There was a liberal use of ICS containing drug combinations in subjects who do not have an indication for ICS. A considerable proportion of subjects at high risk of exacerbations did not receive ICS treatment.",2021,"In groups A, B, C and D, respectively, 21%, 11%, 11% and 5% did not receive any inhaler therapy; 67%, 81%, 81% and 90% received long-acting bronchodilators; 33%, 46%, 55% and 71% received any ICS containing therapy and 19%, 34%, 39% and 61% received triple therapy. ","['chronic obstructive pulmonary disease (COPD', 'subjects who do not have an indication for ICS', 'Patients with a co-diagnosis of asthma were excluded', '15,595 COPD patients from 853 primary care and 125 secondary care clinics']","['ICS', 'no pharmacological treatment, short-acting bronchodilators alone, long-acting bronchodilators alone and ICS alone or in combination with bronchodilators']","['mMRC score', 'symptoms (CAT, mMRC), lung function, exacerbation history and pharmacological treatment']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C0205166', 'cui_str': 'Long'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",15595.0,0.0872459,"In groups A, B, C and D, respectively, 21%, 11%, 11% and 5% did not receive any inhaler therapy; 67%, 81%, 81% and 90% received long-acting bronchodilators; 33%, 46%, 55% and 71% received any ICS containing therapy and 19%, 34%, 39% and 61% received triple therapy. ","[{'ForeName': 'Kjell', 'Initials': 'K', 'LastName': 'Larsson', 'Affiliation': 'Integrative Toxicology, National Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Ekberg-Jansson', 'Affiliation': 'Institute of Medicine, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Stridsman', 'Affiliation': 'Department of Public Health and Clinical Medicine, Division of Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Hanno', 'Affiliation': 'Boehringer Ingelheim AB, Stockholm, Sweden.'}, {'ForeName': 'Lowie E G W', 'Initials': 'LEGW', 'LastName': 'Vanfleteren', 'Affiliation': 'COPD Center, Department of Respiratory Medicine and Allergology, Sahlgrenska University Hospital, Gothenburg, 413 45, Sweden.'}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S300299'] 3749,33854307,Changes in Body Composition and Cardiometabolic Health After Detraining in Older Men with Osteosarcopenia: 6-Month Follow-Up of the Randomized Controlled Franconian Osteopenia and Sarcopenia Trial (FrOST) Study.,"Purpose Temporary cessation of exercise but maintenance of habitual physical activity might be a frequent situation in older people's lives. Particularly the COVID-19 induced lockdown of exercise training facilities with individual outdoor activities still being allowed might be a blueprint for this potentially harmful scenario. Thus, the aim of the present study was to determine the effects of 6 months of detraining after 18 months of high-intensity resistance exercise (HIT-RT) on body composition and cardiometabolic outcomes in predominately obese older men with osteosarcopenia. Materials and Methods Community-dwelling predominately obese men 72-91 years old with low muscle and bone mass (n=43) were randomly assigned to an 18-month HIT-RT (EG: n=21) or a non-training control group (CG, n=22). After the intervention, participants of the EG discontinued HIT-RT for 6 months, but increased their habitual physical activity. Study outcomes were group differences in detraining changes (""effects"") for lean body mass (LBM), total and abdominal body fat rate (determined by dual-energy x-ray absorptiometry) and the Metabolic Syndrome Z-Score (MetSZ). We applied an intention-to-treat analysis with multiple imputation to analyze the data. Results After the 18-month HIT-RT, we observed significant positive training effects for LBM, total and abdominal body fat rate and the MetSZ (all p<0.001). Abrupt cessation of HIT-RT for 6 months resulted in significantly higher unfavorable changes in the HIT-RT compared with the CG for LBM (p=0.001), total body fat (p=0.003) and the MetSZ (p=0.003), apart from abdominal body fat (p=0.059). However, significant overall effects were still present after 24 months for LBM and body fat indices but not for the MetSZ. Conclusion The present study clearly indicates the unfavorable effects of 6 months of detraining after HIT-RT. Correspondingly, exercise protocols particularly for older people should focus on continuous exercise with short regeneration periods rather than on intermitted protocols with pronounced training breaks.",2021,"However, significant overall effects were still present after 24 months for LBM and body fat indices but not for the MetSZ. ","['Older Men with Osteosarcopenia', 'predominately obese older men with osteosarcopenia', ""older people's lives"", 'Materials and Methods\n\n\nCommunity-dwelling predominately obese men 72-91 years old with low muscle and bone mass (n=43']",['high-intensity resistance exercise (HIT-RT'],"['LBM, total and abdominal body fat rate and the MetSZ', 'detraining changes (""effects"") for lean body mass (LBM), total and abdominal body fat rate (determined by dual-energy x-ray absorptiometry) and the Metabolic Syndrome Z-Score (MetSZ', 'total body fat', 'body composition and cardiometabolic outcomes', 'habitual physical activity', 'Body Composition and Cardiometabolic Health']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332251', 'cui_str': 'Predominate'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0424677', 'cui_str': 'Total body fat'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0125981,"However, significant overall effects were still present after 24 months for LBM and body fat indices but not for the MetSZ. ","[{'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Kemmler', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander University of Erlangen-Nürnberg, Erlangen, 91053, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schoene', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander University of Erlangen-Nürnberg, Erlangen, 91053, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Kohl', 'Affiliation': 'Faculty Medical and Life Sciences, University of Furtwangen, Villingen-Schwenningen, 78054, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'von Stengel', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander University of Erlangen-Nürnberg, Erlangen, 91053, Germany.'}]",Clinical interventions in aging,['10.2147/CIA.S299867'] 3750,33854301,The Effect of Lidocaine on Postoperative Quality of Recovery and Lung Protection of Patients Undergoing Thoracoscopic Radical Resection of Lung Cancer.,"Purpose To evaluate the effectiveness and safety of lidocaine on postoperative quality of recovery and lung protection of patients undergoing thoracoscopic radical resection of lung cancer. Patients and Methods Seventy ASA II-III patients undergoing thoracoscopic radical resection of lung cancer were randomly assigned into either the lidocaine group (Group L) or control group (Group C). Patients in Group L received lidocaine with a 1.5 mg/kg bolus before induction of anesthesia, followed by 2.0 mg/kg/h until the end of the operation while the patients in Group C received volume-matched normal saline at the same rate. The main outcome was the quality of recovery-40 score (QoR-40 score) at 24 h postoperatively. The peak airway pressure (Ppeak) and plateau airway pressure (Pplat), the partial pressure of oxygen in arterial blood (PaO 2 ), partial pressure of carbon dioxide in arterial blood (PaCO 2 ), alveolar-arterial oxygen gradient (A-aDO2), oxygenation index (OI), time to first flatus and defecation, intraoperative hemodynamics and opioid consumption were also recorded. Results There were no statistically difference at patients' baseline characteristics. The QoR-40 score of Group L was significantly higher than that of Group C at 24 h after surgery ( P =0.014). Ppeak, Pplat, and A-aDO 2 of Group L were significantly lower than those of Group C ( P <0.001, P <0.001, P =0.025, respectively) after the ventilation recovery of both lungs, and the PaO 2 and OI of the Group L were significantly higher than those of Group C ( P =0.027, P =0.027, respectively). Time to first flatus and defecation in Group L was significantly lower compared with Group C ( P =0.037, P =0.025, respectively). Conclusion Intravenous lidocaine can improve the quality of recovery of patients undergoing thoracoscopic radical resection of lung cancer, while also providing lung protection, favorable postoperative analgesia, a reduction in the time to first flatus and defecation after surgery.",2021,"Time to first flatus and defecation in Group L was significantly lower compared with Group C ( P =0.037, P =0.025, respectively). ","['Patients Undergoing Thoracoscopic Radical Resection of Lung Cancer', 'Patients and Methods\n\n\nSeventy ASA II-III patients undergoing thoracoscopic radical resection of lung cancer', 'patients undergoing thoracoscopic radical resection of lung cancer']","['lidocaine', 'volume-matched normal saline', 'Lidocaine']","['Time to first flatus and defecation', 'QoR-40 score of Group L', 'quality of recovery-40 score (QoR-40 score', 'quality of recovery', 'postoperative quality of recovery and lung protection', 'peak airway pressure (Ppeak) and plateau airway pressure (Pplat), the partial pressure of oxygen in arterial blood (PaO 2 ), partial pressure of carbon dioxide in arterial blood (PaCO 2 ), alveolar-arterial oxygen gradient (A-aDO2), oxygenation index (OI), time to first flatus and defecation, intraoperative hemodynamics and opioid consumption', 'Postoperative Quality of Recovery and Lung Protection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0396565', 'cui_str': 'Lung excision'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441846', 'cui_str': 'Group L'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C1822073', 'cui_str': 'PaO2'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0229665', 'cui_str': 'Arterial blood'}, {'cui': 'C3203470', 'cui_str': 'Alveolar-arterial oxygen gradient'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",70.0,0.203953,"Time to first flatus and defecation in Group L was significantly lower compared with Group C ( P =0.037, P =0.025, respectively). ","[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, People's Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': ""Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, People's Republic of China.""}, {'ForeName': 'Xueguang', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, People's Republic of China.""}, {'ForeName': 'Guanglei', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': ""Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, People's Republic of China.""}]","Drug design, development and therapy",['10.2147/DDDT.S297642'] 3751,33854299,"Erratum: Low-Dose Triple Antihypertensive Combination Therapy in Patients with Hypertension: A Randomized, Double-Blind, Phase II Study [Corrigendum].",[This corrects the article DOI: 10.2147/DDDT.S286586.].,2021,[This corrects the article DOI: 10.2147/DDDT.S286586.].,['Patients with Hypertension'],['Erratum: Low-Dose Triple Antihypertensive Combination Therapy'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]",[],,0.213181,[This corrects the article DOI: 10.2147/DDDT.S286586.].,[],"Drug design, development and therapy",['10.2147/DDDT.S313293'] 3752,33854132,TMS-EEG signatures of glutamatergic neurotransmission in human cortex.,"Neuronal activity in the brain reflects an excitation-inhibition balance that is regulated predominantly by glutamatergic and GABAergic neurotransmission, and often disturbed in neuropsychiatric disorders. Here, we tested the effects of a single oral dose of two anti-glutamatergic drugs (dextromethorphan, an NMDA receptor antagonist; perampanel, an AMPA receptor antagonist) and an L-type voltage-gated calcium channel blocker (nimodipine) on transcranial magnetic stimulation (TMS)-evoked electroencephalographic (EEG) potentials (TEPs) and TMS-induced oscillations (TIOs) in 16 healthy adults in a pseudorandomized, double-blinded, placebo-controlled crossover design. Single-pulse TMS was delivered to the hand area of left primary motor cortex. Dextromethorphan increased the amplitude of the N45 TEP, while it had no effect on TIOs. Perampanel reduced the amplitude of the P60 TEP in the non-stimulated hemisphere, and increased TIOs in the beta-frequency band in the stimulated sensorimotor cortex, and in the alpha-frequency band in midline parietal channels. Nimodipine and placebo had no effect on TEPs and TIOs. The TEP results extend previous pharmaco-TMS-EEG studies by demonstrating that the N45 is regulated by a balance of GABAAergic inhibition and NMDA receptor-mediated glutamatergic excitation. In contrast, AMPA receptor-mediated glutamatergic neurotransmission contributes to propagated activity reflected in the P60 potential and midline parietal induced oscillations. This pharmacological characterization of TMS-EEG responses will be informative for interpreting TMS-EEG abnormalities in neuropsychiatric disorders with pathological excitation-inhibition balance.",2021,"Perampanel reduced the amplitude of the P60 TEP in the non-stimulated hemisphere, and increased TIOs in the beta-frequency band in the stimulated sensorimotor cortex, and in the alpha-frequency band in midline parietal channels.","['human cortex', '16 healthy adults in a pseudorandomized, double-blinded']","['Perampanel', 'two anti-glutamatergic drugs (dextromethorphan, an NMDA receptor antagonist; perampanel, an AMPA receptor antagonist) and an L-type voltage-gated calcium channel blocker (nimodipine', 'Single-pulse TMS', 'placebo', 'Nimodipine and placebo', 'transcranial magnetic stimulation (TMS)-evoked electroencephalographic (EEG) potentials (TEPs) and TMS-induced oscillations (TIOs', 'Dextromethorphan']","['amplitude of the P60 TEP', 'TEPs and TIOs']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0004302', 'cui_str': 'Auditory area of cortex'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C2698764', 'cui_str': 'perampanel'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0598695', 'cui_str': 'NMDA receptor antagonist'}, {'cui': 'C4722020', 'cui_str': 'Alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor antagonist'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0237633', 'cui_str': 'Sensory Filtering'}, {'cui': 'C0006684', 'cui_str': 'Calcium channel blocker'}, {'cui': 'C0028094', 'cui_str': 'Nimodipine'}, {'cui': 'C1564622', 'cui_str': 'Transcranial Magnetic Stimulation, Single Pulse'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C1137054', 'cui_str': 'SQSTM1 protein, human'}, {'cui': 'C0145334', 'cui_str': 'tetraethylpyrazine'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",16.0,0.0557588,"Perampanel reduced the amplitude of the P60 TEP in the non-stimulated hemisphere, and increased TIOs in the beta-frequency band in the stimulated sensorimotor cortex, and in the alpha-frequency band in midline parietal channels.","[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Belardinelli', 'Affiliation': 'Department of Neurology and Stroke, University of Tübingen, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany.'}, {'ForeName': 'Franca', 'Initials': 'F', 'LastName': 'König', 'Affiliation': 'Department of Neurology and Stroke, University of Tübingen, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Liang', 'Affiliation': 'Department of Neurology and Stroke, University of Tübingen, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Premoli', 'Affiliation': ""Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Desideri', 'Affiliation': 'Department of Neurology and Stroke, University of Tübingen, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Müller-Dahlhaus', 'Affiliation': 'Department of Neurology and Stroke, University of Tübingen, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany.'}, {'ForeName': 'Pedro Caldana', 'Initials': 'PC', 'LastName': 'Gordon', 'Affiliation': 'Department of Neurology and Stroke, University of Tübingen, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Zipser', 'Affiliation': 'Department of Neurology and Stroke, University of Tübingen, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Zrenner', 'Affiliation': 'Department of Neurology and Stroke, University of Tübingen, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Ziemann', 'Affiliation': 'Department of Neurology and Stroke, University of Tübingen, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany. ulf.ziemann@uni-tuebingen.de.'}]",Scientific reports,['10.1038/s41598-021-87533-z'] 3753,33854065,Accelerated phase Ia/b evaluation of the malaria vaccine candidate PfAMA1 DiCo demonstrates broadening of humoral immune responses.,"Plasmodium falciparum apical membrane antigen 1 (PfAMA1) is a candidate malaria vaccine antigen expressed on merozoites and sporozoites. PfAMA1's polymorphic nature impacts vaccine-induced protection. To address polymorphism, three Diversity Covering (DiCo) protein sequences were designed and tested in a staggered phase Ia/b trial. A cohort of malaria-naive adults received PfAMA1-DiCo adjuvanted with Alhydrogel® or GLA-SE and a cohort of malaria-exposed adults received placebo or GLA-SE adjuvanted PfAMA1 DiCo at weeks 0, 4 and 26. IgG and GIA levels measured 4 weeks after the third vaccination are similar in malaria-naive volunteers and placebo-immunised malaria-exposed adults, and have a similar breadth. Vaccination of malaria-exposed adults results in significant antibody level increases to the DiCo variants, but not to naturally occurring PfAMA1 variants. Moreover, GIA levels do not increase following vaccination. Future research will need to focus on stronger adjuvants and/or adapted vaccination regimens, to induce potentially protective responses in the target group of the vaccine.",2021,"IgG and GIA levels measured 4 weeks after the third vaccination are similar in malaria-naive volunteers and placebo-immunised malaria-exposed adults, and have a similar breadth.",[],"['PfAMA1-DiCo adjuvanted with Alhydrogel® or GLA-SE', 'placebo', 'placebo or GLA-SE adjuvanted PfAMA1 DiCo']","['GIA levels', 'IgG and GIA levels']",[],"[{'cui': 'C0032150', 'cui_str': 'Plasmodium falciparum'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0733770', 'cui_str': 'Alhydrogel'}, {'cui': 'C0061078', 'cui_str': 'gamolenic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}]",,0.111542,"IgG and GIA levels measured 4 weeks after the third vaccination are similar in malaria-naive volunteers and placebo-immunised malaria-exposed adults, and have a similar breadth.","[{'ForeName': 'Edmond J', 'Initials': 'EJ', 'LastName': 'Remarque', 'Affiliation': 'Biomedical Primate Research Centre, Rijswijk, The Netherlands.'}, {'ForeName': 'Bart W', 'Initials': 'BW', 'LastName': 'Faber', 'Affiliation': 'Biomedical Primate Research Centre, Rijswijk, The Netherlands. Faber@bprc.nl.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Rodriguez Garcia', 'Affiliation': 'Biomedical Primate Research Centre, Rijswijk, The Netherlands.'}, {'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'Oostermeijer', 'Affiliation': 'Biomedical Primate Research Centre, Rijswijk, The Netherlands.'}, {'ForeName': 'Sodiomon B', 'Initials': 'SB', 'LastName': 'Sirima', 'Affiliation': 'Centre National de Recherche et de Formation sur le Paludisme (CNRFP), Ouagadougou, Burkina Faso.'}, {'ForeName': 'Issa', 'Initials': 'I', 'LastName': 'Nebie Ouedraogo', 'Affiliation': 'Centre National de Recherche et de Formation sur le Paludisme (CNRFP), Ouagadougou, Burkina Faso.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Kara', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Cochin, CIC Cochin-Pasteur, Paris, France.'}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Launay', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Cochin, CIC Cochin-Pasteur, Paris, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Houard', 'Affiliation': 'European vaccine initiative, Heidelberg, Germany.'}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Leroy', 'Affiliation': 'European vaccine initiative, Heidelberg, Germany.'}, {'ForeName': 'Clemens H M', 'Initials': 'CHM', 'LastName': 'Kocken', 'Affiliation': 'Biomedical Primate Research Centre, Rijswijk, The Netherlands.'}]",NPJ vaccines,['10.1038/s41541-021-00319-2'] 3754,33854039,Metformin for early comorbid glucose dysregulation and schizophrenia spectrum disorders: a pilot double-blind randomized clinical trial.,"Patients with schizophrenia have exceedingly high rates of metabolic comorbidity including type 2 diabetes and lose 15-20 years of life due to cardiovascular diseases, with early accrual of cardiometabolic disease. In this study, thirty overweight or obese (Body Mass Index (BMI) > 25) participants under 40 years old with schizophrenia spectrum disorders and early comorbid prediabetes or type 2 diabetes receiving antipsychotic medications were randomized, in a double-blind fashion, to metformin 1500 mg/day or placebo (2:1 ratio; n = 21 metformin and n = 9 placebo) for 4 months. The primary outcome measures were improvements in glucose homeostasis (HbA1c, fasting glucose) and insulin resistance (Matsuda index-derived from oral glucose tolerance tests and homeostatic model of insulin resistance (HOMA-IR)). Secondary outcome measures included changes in weight, MRI measures of fat mass and distribution, symptom severity, cognition, and hippocampal volume. Twenty-two patients (n = 14 metformin; n = 8 placebo) completed the trial. The metformin group had a significant decrease over time in the HOMA-IR (p = 0.043) and fasting blood glucose (p = 0.007) vs. placebo. There were no differences between treatment groups in the Matsuda index, HbA1c, which could suggest liver-specific effects of metformin. There were no between group differences in other secondary outcome measures, while weight loss in the metformin arm correlated significantly with decreases in subcutaneous, but not visceral or hepatic adipose tissue. Our results show that metformin improved dysglycemia and insulin sensitivity, independent of weight loss, in a young population with prediabetes/diabetes and psychosis spectrum illness, that is at extremely high risk of early cardiovascular mortality. Trial Registration: This protocol was registered with clinicaltrials.gov (NCT02167620).",2021,The metformin group had a significant decrease over time in the HOMA-IR (p = 0.043) and fasting blood glucose (p = 0.007) vs. placebo.,"['Twenty-two patients (n\u2009=\u200914 metformin; n\u2009=\u20098', 'early comorbid glucose dysregulation and schizophrenia spectrum disorders', 'thirty overweight or obese (Body Mass Index', 'participants under 40 years old with schizophrenia spectrum disorders and early comorbid prediabetes or type 2 diabetes receiving antipsychotic medications', 'Patients with schizophrenia have exceedingly high rates of metabolic comorbidity including type 2 diabetes and lose 15-20 years of life due to cardiovascular diseases, with early accrual of cardiometabolic disease']","['metformin', 'metformin 1500\u2009mg/day or placebo (2:1 ratio; n\u2009=\u200921 metformin and n\u2009=\u20099 placebo', 'placebo', 'Metformin']","['dysglycemia and insulin sensitivity', 'HOMA-IR', 'changes in weight, MRI measures of fat mass and distribution, symptom severity, cognition, and hippocampal volume', 'glucose homeostasis (HbA1c, fasting glucose) and insulin resistance (Matsuda index-derived from oral glucose tolerance tests and homeostatic model of insulin resistance (HOMA-IR', 'fasting blood glucose', 'weight loss', 'visceral or hepatic adipose tissue']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C1960636', 'cui_str': 'Dysglycemia'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}]",30.0,0.391183,The metformin group had a significant decrease over time in the HOMA-IR (p = 0.043) and fasting blood glucose (p = 0.007) vs. placebo.,"[{'ForeName': 'Sri Mahavir', 'Initials': 'SM', 'LastName': 'Agarwal', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Roshni', 'Initials': 'R', 'LastName': 'Panda', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Kenya A', 'Initials': 'KA', 'LastName': 'Costa-Dookhan', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'MacKenzie', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Quinn Casuccio', 'Initials': 'QC', 'LastName': 'Treen', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Caravaggio', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Eyesha', 'Initials': 'E', 'LastName': 'Hashim', 'Affiliation': ""St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'General', 'Initials': 'G', 'LastName': 'Leung', 'Affiliation': ""St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Anish', 'Initials': 'A', 'LastName': 'Kirpalani', 'Affiliation': ""St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Matheson', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Araba F', 'Initials': 'AF', 'LastName': 'Chintoh', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Caroline K', 'Initials': 'CK', 'LastName': 'Kramer', 'Affiliation': 'Mount Sinai Hospital, Toronto, ON, Canada.'}, {'ForeName': 'Aristotle N', 'Initials': 'AN', 'LastName': 'Voineskos', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Graff-Guerrero', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Remington', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Margaret K', 'Initials': 'MK', 'LastName': 'Hahn', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada. Margaret.Hahn@camh.ca.'}]",Translational psychiatry,['10.1038/s41398-021-01338-2'] 3755,33854007,"Multicenter, Randomized, Placebo-controlled Trial to Evaluate the Efficacy and Safety of a Controlled-release, Once-daily UIC201609/UIC201610 Combination Therapy for Functional Dyspepsia: Preliminary Study.","Background/Aims : Functional dyspepsia is a disease involving a range of upper gastrointestinal symptoms derived from various pathophysiologies. Tablets containing a combination of rabeprazole and controlled-release (CR) mosapride were recently developed. To investigate a more effective treatment, this trial evaluated the efficacy and safety of UIC201609/UIC201610 as a preliminary study. Methods A multicenter, double-blind, randomized study was performed on 30 subjects. UIC201609/UIC201610 (combination of rabeprazole and CR mosapride) was the case group, and the two control groups were rabeprazole 10 mg once a day and mosapride 15 mg CR tablet once a day. As a primary efficacy endpoint of the study, the changes in the total score of eight items of the Nepean Dyspepsia Index-Korean version were analyzed at 2 weeks and 4 weeks. The outcomes regarding safety were collected. Results The total symptom score of Nepean Dyspepsia Index-Korean decreased in the rabeprazole single group (29.4±17.1), mosapride CR single group (33.4±15.6), and UIC201609/UIC201610 group (33.4±11.8) at 4 weeks without significant differences. On the other hand, the UIC201609/UIC201610 combination group showed more score reduction of pain in the upper abdomen, burning in the upper abdomen compared to each control group, but it did not reach statistical significance. No difference was found in safety analysis. Conclusions UIC201609/UIC201610 once daily showed some improvement in epigastric pain and dyspepsia in patients with functional dyspepsia, but there was no significance. Further study based on the advanced clinical trial design will be needed to confirm the efficacy of UIC201609/UIC201610 combination therapy in the future.",2021,"The total symptom score of Nepean Dyspepsia Index-Korean decreased in the rabeprazole single group (29.4±17.1), mosapride CR single group (33.4±15.6), and UIC201609/UIC201610 group (33.4±11.8) at 4 weeks without significant differences.","['Functional Dyspepsia', '30 subjects', 'patients with functional dyspepsia']","['UIC201609/UIC201610 (combination of rabeprazole and CR mosapride', 'UIC201609/UIC201610 combination therapy', 'rabeprazole', 'Controlled-release, Once-daily UIC201609/UIC201610 Combination Therapy', 'rabeprazole and controlled-release (CR) mosapride', 'Placebo', 'UIC201609/UIC201610']","['score reduction of pain', 'Efficacy and Safety', 'safety analysis', 'total symptom score of Nepean Dyspepsia Index-Korean', 'epigastric pain and dyspepsia', 'Functional dyspepsia', 'total score of eight items of the Nepean Dyspepsia Index-Korean version']","[{'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0378482', 'cui_str': 'rabeprazole'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0526501', 'cui_str': 'mosapride'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0232493', 'cui_str': 'Epigastric pain'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C2607870', 'cui_str': 'Version'}]",30.0,0.0890873,"The total symptom score of Nepean Dyspepsia Index-Korean decreased in the rabeprazole single group (29.4±17.1), mosapride CR single group (33.4±15.6), and UIC201609/UIC201610 group (33.4±11.8) at 4 weeks without significant differences.","[{'ForeName': 'Jung Won', 'Initials': 'JW', 'LastName': 'Lee', 'Affiliation': 'Department of Internal medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.'}, {'ForeName': 'Young Hoon', 'Initials': 'YH', 'LastName': 'Youn', 'Affiliation': 'Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Suck Chei', 'Initials': 'SC', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, Digestive Disease Research Institute, Wonkwang University College of Medicine, Iksan, Korea.'}, {'ForeName': 'Kwang Jae', 'Initials': 'KJ', 'LastName': 'Lee', 'Affiliation': 'Department of Gastroenterology, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Nayoung', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'Department of Internal medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.'}]",The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi,['10.4166/kjg.2020.171'] 3756,33853878,Continued versus discontinued oxytocin stimulation in the active phase of labour (CONDISOX): double blind randomised controlled trial.,"OBJECTIVE To determine whether discontinuing oxytocin stimulation in the active phase of induced labour is associated with lower caesarean section rates. DESIGN International multicentre, double blind, randomised controlled trial. SETTING Nine hospitals in Denmark and one in the Netherlands between 8 April 2016 and 30 June 2020. PARTICIPANTS 1200 women stimulated with intravenous oxytocin infusion during the latent phase of induced labour. INTERVENTION Women were randomly assigned to have their oxytocin stimulation discontinued or continued in the active phase of labour. MAIN OUTCOME MEASURE Delivery by caesarean section. RESULTS A total of 607 women were assigned to discontinuation and 593 to continuation of the oxytocin infusion. The rates of caesarean section were 16.6% (n=101) in the discontinued group and 14.2% (n=84) in the continued group (relative risk 1.17, 95% confidence interval 0.90 to 1.53). In 94 parous women with no previous caesarean section, the caesarean section rate was 7.5% (11/147) in the discontinued group and 0.6% (1/155)in the continued group (relative risk 11.6, 1.15 to 88.7). Discontinuation was associated with longer duration of labour (median from randomisation to delivery 282 v 201 min; P<0.001), a reduced risk of hyperstimulation (20/546 (3.7%) v 70/541 (12.9%); P<0.001), and a reduced risk of fetal heart rate abnormalities (153/548 (27.9%) v 219/537 (40.8%); P<0.001) but rates of other adverse maternal and neonatal outcomes were similar between groups. CONCLUSIONS In a setting where monitoring of the fetal condition and the uterine contractions can be guaranteed, routine discontinuation of oxytocin stimulation may lead to a small increase in caesarean section rate but a significantly reduced risk of uterine hyperstimulation and abnormal fetal heart rate patterns. TRIAL REGISTRATION ClinicalTrials.gov NCT02553226.",2021,"Discontinuation was associated with longer duration of labour (median from randomisation to delivery 282 v 201 min; P<0.001), a reduced risk of hyperstimulation (20/546 (3.7%) v 70/541 (12.9%); P<0.001), and a reduced risk of fetal heart rate abnormalities (153/548 (27.9%) v 219/537 (40.8%); P<0.001) but rates of other adverse maternal and neonatal outcomes were similar between groups. ","['607 women', '94 parous women with no previous caesarean section, the', 'infusion during the latent phase of induced labour', 'Nine hospitals in Denmark and one in the Netherlands between 8 April 2016 and 30 June 2020', '1200 women stimulated with']","['discontinuing oxytocin stimulation', 'oxytocin infusion', 'discontinued oxytocin stimulation', 'oxytocin stimulation discontinued or continued in the active phase of labour', 'intravenous oxytocin']","['caesarean section rate', 'adverse maternal and neonatal outcomes', 'reduced risk of hyperstimulation', 'reduced risk of fetal heart rate abnormalities', 'rates of caesarean section', 'longer duration of labour']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0269733', 'cui_str': 'Previous caesarean section'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0022875', 'cui_str': 'Onset of labor induced'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4517548', 'cui_str': '1200'}]","[{'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018811', 'cui_str': 'Fetal heart rate'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0566671', 'cui_str': 'Long duration of labor'}]",607.0,0.278419,"Discontinuation was associated with longer duration of labour (median from randomisation to delivery 282 v 201 min; P<0.001), a reduced risk of hyperstimulation (20/546 (3.7%) v 70/541 (12.9%); P<0.001), and a reduced risk of fetal heart rate abnormalities (153/548 (27.9%) v 219/537 (40.8%); P<0.001) but rates of other adverse maternal and neonatal outcomes were similar between groups. ","[{'ForeName': 'Sidsel', 'Initials': 'S', 'LastName': 'Boie', 'Affiliation': 'Department of Obstetrics and Gynaecology, Randers Regional Hospital, Randers, Denmark.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Glavind', 'Affiliation': 'Department of Obstetrics and Gynaecology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Uldbjerg', 'Affiliation': 'Department of Obstetrics and Gynaecology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Steer', 'Affiliation': 'Academic Department of Obstetrics and Gynaecology, Chelsea and Westminster Hospital, Imperial College London, London, UK.'}, {'ForeName': 'Pinar', 'Initials': 'P', 'LastName': 'Bor', 'Affiliation': 'Department of Obstetrics and Gynaecology, Randers Regional Hospital, Randers, Denmark.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ (Clinical research ed.),['10.1136/bmj.n716'] 3757,33853868,Virtual learning collaboratives to improve urine culturing and antibiotic prescribing in long-term care: controlled before-and-after study.,"BACKGROUND Urine culturing practices are highly variable in long-term care and contribute to overprescribing of antibiotics for presumed urinary tract infections. The purpose of this study was to evaluate the use of virtual learning collaboratives to support long-term care homes in implementing a quality improvement programme focused on reducing unnecessary urine culturing and antibiotic overprescribing. METHODS Over a 4-month period (May 2018-August 2018), 45 long-term care homes were self-selected from five regions to participate in virtual learning collaborative sessions, which provided an orientation to a quality improvement programme and guidance for implementation. A process evaluation complemented the use of a controlled before-and-after study with a propensity score matched control group (n=127) and a difference-in-difference analysis. Primary outcomes included rates of urine cultures performed and urinary antibiotic prescriptions. Secondary outcomes included rates of emergency department visits, hospital admission and mortality. An 18-month baseline period was compared with a 16-month postimplementation period with the use of administrative data sources. RESULTS Rates of urine culturing and urinary antibiotic prescriptions per 1000 resident days decreased significantly more among long-term care homes that participated in learning collaboratives compared with matched controls (differential reductions of 19% and 13%, respectively, p<0.0001). There was no statistically significant changes to rates of emergency department visits, hospital admissions or mortality. These outcomes were observed with moderate adherence to the programme model. CONCLUSIONS Rates of urine culturing and urinary antibiotic prescriptions declined among long-term care homes that participated in a virtual learning collaborative to support implementation of a quality improvement programme. The results of this study have refined a model to scale this programme in long-term care.",2021,"RESULTS Rates of urine culturing and urinary antibiotic prescriptions per 1000 resident days decreased significantly more among long-term care homes that participated in learning collaboratives compared with matched controls (differential reductions of 19% and 13%, respectively, p<0.0001).",[],"['Virtual learning collaboratives', 'virtual learning collaboratives']","['urine culturing and antibiotic prescribing', 'Rates of urine culturing and urinary antibiotic prescriptions', 'rates of emergency department visits, hospital admissions or mortality', 'rates of emergency department visits, hospital admission and mortality', 'rates of urine cultures performed and urinary antibiotic prescriptions']",[],"[{'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0430404', 'cui_str': 'Urine culture'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]",,0.0568664,"RESULTS Rates of urine culturing and urinary antibiotic prescriptions per 1000 resident days decreased significantly more among long-term care homes that participated in learning collaboratives compared with matched controls (differential reductions of 19% and 13%, respectively, p<0.0001).","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Chambers', 'Affiliation': 'Public Health Ontario, Toronto, Ontario, Canada Andrea.Chaplin@oahpp.ca.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Public Health Ontario, Toronto, Ontario, Canada.'}, {'ForeName': 'Kevin Antoine', 'Initials': 'KA', 'LastName': 'Brown', 'Affiliation': 'Public Health Ontario, Toronto, Ontario, Canada.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Daneman', 'Affiliation': 'Public Health Ontario, Toronto, Ontario, Canada.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Langford', 'Affiliation': 'Public Health Ontario, Toronto, Ontario, Canada.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Leung', 'Affiliation': 'Public Health Ontario, Toronto, Ontario, Canada.'}, {'ForeName': 'Kwaku', 'Initials': 'K', 'LastName': 'Adomako', 'Affiliation': 'Public Health Ontario, Toronto, Ontario, Canada.'}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Schwartz', 'Affiliation': 'Public Health Ontario, Toronto, Ontario, Canada.'}, {'ForeName': 'Julia E', 'Initials': 'JE', 'LastName': 'Moore', 'Affiliation': 'Center for Implementation, Toronto, Ontario, Canada.'}, {'ForeName': 'Jacquelyn', 'Initials': 'J', 'LastName': 'Quirk', 'Affiliation': 'Public Health Ontario, Toronto, Ontario, Canada.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'MacFarlane', 'Affiliation': 'Public Health Ontario, Toronto, Ontario, Canada.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Cronsberry', 'Affiliation': 'Public Health Ontario, Toronto, Ontario, Canada.'}, {'ForeName': 'Gary E', 'Initials': 'GE', 'LastName': 'Garber', 'Affiliation': 'Public Health Ontario, Toronto, Ontario, Canada.'}]",BMJ quality & safety,['10.1136/bmjqs-2020-012226'] 3758,33853811,Correction: Epley manoeuvre for posterior semicircular canal benign paroxysmal positional vertigo in people with multiple sclerosis: protocol of a randomised controlled trial.,,2021,,['posterior semicircular canal benign paroxysmal positional vertigo in people with multiple sclerosis'],[],[],"[{'cui': 'C0229454', 'cui_str': 'Structure of posterior semicircular duct'}, {'cui': 'C0155502', 'cui_str': 'Benign paroxysmal positional vertigo'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]",[],[],,0.170121,,[],BMJ open,['10.1136/bmjopen-2020-046510corr1'] 3759,33853807,Minimally invasive versus conventional sternotomy for Mitral valve repair: protocol for a multicentre randomised controlled trial (UK Mini Mitral).,"INTRODUCTION Numbers of patients undergoing mitral valve repair (MVr) surgery for severe mitral regurgitation have grown and will continue to rise. MVr is routinely performed via median sternotomy; however, there is a move towards less invasive surgical approaches.There is debate within the clinical and National Health Service (NHS) commissioning community about widespread adoption of minimally invasive MVr surgery in the absence of robust research evidence; implementation requires investment in staff and infrastructure.The UK Mini Mitral trial will provide definitive evidence comparing patient, NHS and clinical outcomes in adult patients undergoing MVr surgery. It will establish the best surgical approach for MVr, setting a standard against which emerging percutaneous techniques can be measured. Findings will inform optimisation of cost-effective practice. METHODS AND ANALYSIS UK Mini Mitral is a multicentre, expertise based randomised controlled trial of minimally invasive thoracoscopically guided right minithoracotomy versus conventional sternotomy for MVr. The trial is taking place in NHS cardiothoracic centres in the UK with established minimally invasive mitral valve surgery programmes. In each centre, consenting and eligible patients are randomised to receive surgery performed by consultant surgeons who meet protocol-defined surgical expertise criteria. Patients are followed for 1 year, and consent to longer term follow-up.Primary outcome is physical functioning 12 weeks following surgery, measured by change in Short Form Health Survey (SF-36v2) physical functioning scale. Early and 1 year echo data will be reported by a core laboratory. Estimates of key clinical and health economic outcomes will be reported up to 5 years.The primary economic outcome is cost effectiveness, measured as incremental cost per quality-adjusted life year gained over 52 weeks following index surgery. ETHICS AND DISSEMINATION A favourable opinion was given by Wales REC 6 (16/WA/0156). Trial findings will be disseminated to patients, clinicians, commissioning groups and through peer reviewed publication. TRIAL REGISTRATION NUMBER ISRCTN13930454.",2021,There is debate within the clinical and National Health Service (NHS) commissioning community about widespread adoption of minimally invasive MVr surgery in the absence of robust research evidence; implementation requires investment in staff and infrastructure.,"['NHS cardiothoracic centres in the UK with established minimally invasive mitral valve surgery programmes', 'adult patients undergoing MVr surgery']","['minimally invasive thoracoscopically guided right minithoracotomy versus conventional sternotomy for MVr', 'Minimally invasive versus conventional sternotomy', 'surgery performed by consultant surgeons who meet protocol-defined surgical expertise criteria', 'mitral valve repair (MVr) surgery']","['physical functioning 12 weeks following surgery, measured by change in Short Form Health Survey (SF-36v2) physical functioning scale', 'cost effectiveness, measured as incremental cost per quality-adjusted life year gained over 52 weeks following index surgery']","[{'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0026264', 'cui_str': 'Mitral valve structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0396849', 'cui_str': 'Mitral valvuloplasty'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0405917', 'cui_str': 'Limited thoracotomy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0185792', 'cui_str': 'Sternotomy'}, {'cui': 'C0396849', 'cui_str': 'Mitral valvuloplasty'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0401972', 'cui_str': 'Consultant surgeon'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.345498,There is debate within the clinical and National Health Service (NHS) commissioning community about widespread adoption of minimally invasive MVr surgery in the absence of robust research evidence; implementation requires investment in staff and infrastructure.,"[{'ForeName': 'Rebecca H', 'Initials': 'RH', 'LastName': 'Maier', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK Rebecca.Maier@newcastle.ac.uk.'}, {'ForeName': 'Adetayo S', 'Initials': 'AS', 'LastName': 'Kasim', 'Affiliation': 'Department of Anthropology, Durham University, Durham, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Zacharias', 'Affiliation': 'The Lancashire Cardiac Centre, Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool, UK.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Vale', 'Affiliation': 'Health Economics Group, Population Health Sciences Institute, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Graham', 'Affiliation': 'Cardiothoracic Surgery, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Walker', 'Affiliation': 'The Lancashire Cardiac Centre, Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool, UK.'}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Laskawski', 'Affiliation': 'The Lancashire Cardiac Centre, Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool, UK.'}, {'ForeName': 'Ranjit', 'Initials': 'R', 'LastName': 'Deshpande', 'Affiliation': ""Cardiothoracic Surgery, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Goodwin', 'Affiliation': 'Cardiothoracic Surgery, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kendall', 'Affiliation': 'Cardiothoracic Surgery, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'Gavin J', 'Initials': 'GJ', 'LastName': 'Murphy', 'Affiliation': 'Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Leicester, UK.'}, {'ForeName': 'Vipin', 'Initials': 'V', 'LastName': 'Zamvar', 'Affiliation': 'Cardiothoracic Surgery, Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Renzo', 'Initials': 'R', 'LastName': 'Pessotto', 'Affiliation': 'Cardiothoracic Surgery, Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Clinton', 'Initials': 'C', 'LastName': 'Lloyd', 'Affiliation': 'Cardiothoracic Surgery, University Hospitals Plymouth NHS Trust, Plymouth, UK.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Dalrymple-Hay', 'Affiliation': 'Cardiothoracic Surgery, University Hospitals Plymouth NHS Trust, Plymouth, UK.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Casula', 'Affiliation': 'Cardiothoracic Surgery, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Hunaid A', 'Initials': 'HA', 'LastName': 'Vohra', 'Affiliation': 'Cardiothoracic Surgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Ciulli', 'Affiliation': 'Cardiothoracic Surgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Caputo', 'Affiliation': 'Bristol Heart Institute, University of Bristol, Bristol, UK.'}, {'ForeName': 'Serban', 'Initials': 'S', 'LastName': 'Stoica', 'Affiliation': 'Cardiothoracic Surgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Baghai', 'Affiliation': ""Cardiothoracic Surgery, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Gunaratnam', 'Initials': 'G', 'LastName': 'Niranjan', 'Affiliation': 'Cardiac Surgery, Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Prakash P', 'Initials': 'PP', 'LastName': 'Punjabi', 'Affiliation': 'Cardiothoracic Surgery, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Wendler', 'Affiliation': ""Cardiothoracic Surgery, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Marsay', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Fernandez-Garcia', 'Affiliation': 'Health Economics Group, Population Health Sciences Institute, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Modi', 'Affiliation': 'Cardiothoracic Surgery, Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Bilal H', 'Initials': 'BH', 'LastName': 'Kirmani', 'Affiliation': 'Cardiothoracic Surgery, Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Pullan', 'Affiliation': 'Cardiothoracic Surgery, Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Muir', 'Affiliation': 'Cardiothoracic Surgery, Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Pousios', 'Affiliation': 'Cardiothoracic Surgery, Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Helen C', 'Initials': 'HC', 'LastName': 'Hancock', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Enoch', 'Initials': 'E', 'LastName': 'Akowuah', 'Affiliation': 'Cardiothoracic Surgery, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.'}]",BMJ open,['10.1136/bmjopen-2020-047676'] 3760,33853806,Multicentre randomised double-blinded placebo-controlled trial of favipiravir in adults with mild COVID-19.,"INTRODUCTION A novel coronavirus, designated SARS-CoV-2, caused an international outbreak of a respiratory illness, termed COVID-19 in December 2019. There is a lack of specific therapeutic agents based on evidence for this novel coronavirus infection; however, several medications have been evaluated as a potential therapy. Therapy is required to treat symptomatic patients and decrease the virus carriage duration to limit the communitytransmission. METHODS AND ANALYSIS We hypothesise that patients with mild COVID-19 treated with favipiravir will have a shorter duration of time to virus clearance than the control group. The primary outcome is to evaluate the effect of favipiravir on the timing of the PCR test conversion from positive to negative within 15 days after starting the medicine.Adults (>18 years, men or nonpregnant women, diagnosed with mild COVID-19 within 5 days of disease onset) are being recruited by physicians participating from the Ministry of National Guard Health Affairs and the Ministry of Health ethics committee approved primary healthcare centres. This double-blind, randomised trial comprises three significant parts: screening, treatment and a follow-up period. The treating physician and patients are blinded. Eligible participants are randomised in a 1:1 ratio to either the therapy group (favipiravir) or a control group (placebo) with 1800 mg by mouth two times per day for the first day, followed by 800 mg two times per day for 4-7 days. Serial nasopharyngeal/oropharyngeal swab samples are obtained on day 1 (5 days before therapy). On day5±1 day, 10±1 day, 15±2 days, extra nasopharyngeal/oropharyngeal PCR COVID-19 samples are requested.The primary analysis population for evaluating both the efficacy and safety outcomes will be a modified intention to treat population. Anticipating a 10% dropout rate, we expect to recruit 288 subjects per arm. The results assume that the hazard ratio is constant throughout the study and that the Cox proportional hazard regression is used to analyse the data. ETHICS AND DISSEMINATION The study was approved by the King Abdullah International Medical Research Centre Institutional Review Board (28 April 2020) and the Ministry of Health Institutional Review Board (1 July 2020). Protocol details and any amendments will be reported to https://clinicaltrials.gov/ct2/show/NCT04464408. The results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER National Clinical Trial Registry (NCT04464408).",2021,"A novel coronavirus, designated SARS-CoV-2, caused an international outbreak of a respiratory illness, termed COVID-19 in December 2019.","['Adults (>18 years, men or nonpregnant women, diagnosed with mild COVID-19 within 5\u2009days of disease onset) are being recruited by physicians participating from the Ministry of National Guard Health Affairs and the Ministry of Health ethics committee approved primary healthcare centres', 'adults with mild COVID-19']","['placebo', 'favipiravir', 'therapy group (favipiravir) or a control group (placebo']",['effect of favipiravir on the timing of the PCR test conversion'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0277793', 'cui_str': 'Onset of illness'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0278253', 'cui_str': 'Guarded prognosis'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085546', 'cui_str': 'Ethics Committees'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1138226', 'cui_str': 'favipiravir'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1138226', 'cui_str': 'favipiravir'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}]",,0.701452,"A novel coronavirus, designated SARS-CoV-2, caused an international outbreak of a respiratory illness, termed COVID-19 in December 2019.","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Bosaeed', 'Affiliation': 'Department of Medicine, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia dr.bosaeed@live.com.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Alharbi', 'Affiliation': 'Department of Medicine, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hussein', 'Affiliation': 'Biostatistics and Bioinformatics, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Abalkhail', 'Affiliation': 'Department of Medicine, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.'}, {'ForeName': 'Khizra', 'Initials': 'K', 'LastName': 'Sultana', 'Affiliation': 'Department of Clinical Trial Services, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'Abrar', 'Initials': 'A', 'LastName': 'Musattat', 'Affiliation': 'Department of Clinical Trial Services, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'Hajar', 'Initials': 'H', 'LastName': 'Alqahtani', 'Affiliation': 'Department of Pharmaceutical Care, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Alshamrani', 'Affiliation': 'Department of Medicine, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Mahmoud', 'Affiliation': 'Department of Medicine, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Alothman', 'Affiliation': 'Department of Medicine, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.'}, {'ForeName': 'Abdulrahman', 'Initials': 'A', 'LastName': 'Alsaedy', 'Affiliation': 'Department of Medicine, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Aldibasi', 'Affiliation': 'College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Alhagan', 'Affiliation': 'Department of Clinical Trial Services, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'Abdullah Mohammed', 'Initials': 'AM', 'LastName': 'Asiri', 'Affiliation': 'Department of Nursing, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.'}, {'ForeName': 'Sameera', 'Initials': 'S', 'LastName': 'AlJohani', 'Affiliation': 'College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.'}, {'ForeName': 'Majed', 'Initials': 'M', 'LastName': 'Al-Jeraisy', 'Affiliation': 'College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Alaskar', 'Affiliation': 'College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.'}]",BMJ open,['10.1136/bmjopen-2020-047495'] 3761,33853802,Cluster randomised controlled trial of a menu box delivery service for Australian long day care services to improve menu guideline compliance: a study protocol.,"INTRODUCTION Globally, children are not meeting the recommended serves of the five food group foods, particularly vegetables. Childcare is an opportune setting to improve children's diet quality. This study aims to assess the effectiveness of a menu box delivery service tailored to the long day care setting to improve menu compliance with recommendations and improve children's food intake while in care. METHODS AND ANALYSIS This study will employ a cluster randomised controlled trial and will recruit eight long day care centres, randomly allocated to the intervention or comparison groups. The intervention group will trial the delivery of a weekly menu box service that includes all ingredients and recipes required to provide morning snack, lunch and afternoon snack. The menu boxes are underpinned by a 4-week menu developed by dietitians and meet menu planning guidelines. The comparison group will receive access to online menu planning training and a menu assessment tool for cooks. The primary outcomes are child dietary intake and menu guideline compliance. Secondary outcomes include within-trial cost-effectiveness and process evaluation measures including intervention acceptability, usability and fidelity. If effective, the menu box delivery will provide an easy strategy for childcare cooks to implement a centre menu that meets menu planning guidelines and improves child intake of five food group foods, including vegetables. ETHICS AND DISSEMINATION This study was approved by the Flinders University Social and Behavioural Research Ethics Committee. Study outcomes will be disseminated in peer-reviewed publications, via local, national and international presentations. Non-traditional outputs including evidence summaries and development of a business case will be used to disseminate study findings to relevant stakeholder groups. Data will be used in a doctoral thesis. TRIAL REGISTRATION NUMBER Australian New Zealand Clinical Trials Registry (ACTRN12620000296932).",2021,"This study aims to assess the effectiveness of a menu box delivery service tailored to the long day care setting to improve menu compliance with recommendations and improve children's food intake while in care. ",[],"['weekly menu box service that includes all ingredients and recipes required to provide morning snack, lunch and afternoon snack', 'online menu planning training and a menu assessment tool for cooks', 'menu box delivery service for Australian long day care services']","['child dietary intake and menu guideline compliance', 'within-trial cost-effectiveness and process evaluation measures including intervention acceptability, usability and fidelity']",[],"[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0600194', 'cui_str': 'Recipes'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0439550', 'cui_str': 'Afternoon'}, {'cui': 'C0025371', 'cui_str': 'Menu Planning'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0011017', 'cui_str': 'Day Care'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",8.0,0.0740575,"This study aims to assess the effectiveness of a menu box delivery service tailored to the long day care setting to improve menu compliance with recommendations and improve children's food intake while in care. ","[{'ForeName': 'Shabnam', 'Initials': 'S', 'LastName': 'Kashef', 'Affiliation': 'College of Nursing and Health Sciences, Flinders University, Bedford Park, South Australia, Australia shabnam.kashef@flinders.edu.au.'}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Zarnowiecki', 'Affiliation': 'College of Nursing and Health Sciences, Flinders University Caring Futures Institute, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Brown', 'Affiliation': 'Deakin Health Economics, Deakin University Faculty of Health, Geelong, Victoria, Australia.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Arguelles', 'Affiliation': 'Nutrition Australia (Victoria), Carlton, South Australia, Australia.'}, {'ForeName': 'David N', 'Initials': 'DN', 'LastName': 'Cox', 'Affiliation': 'Commonwealth Scientific and Industrial Research Organisation (CSIRO) Food and Nutrition, Adelaide, South Australia, Australia.'}, {'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Golley', 'Affiliation': 'College of Nursing and Health Sciences, Flinders University Caring Futures Institute, Adelaide, South Australia, Australia.'}]",BMJ open,['10.1136/bmjopen-2020-045136'] 3762,33853797,Peripherally Inserted Central catheter iNnovation to reduce Infections and Clots (the PICNIC trial): a randomised controlled trial protocol.,"INTRODUCTION Peripherally inserted central catheters (PICCs) are vital for the delivery of medical therapies, but up to 30% of PICCs are associated with complications such as deep vein thrombosis or infection. The integration of antimicrobial and hydrophobic catheter materials, and pressure-activated valves, into polyurethane PICCs are innovations designed to prevent infective and/or thrombotic complications. METHODS AND ANALYSIS A multicentre, parallel group, superiority randomised controlled trial with two experimental arms ((1) hydrophobic PICC (with pressure-activated valve); (2) chlorhexidine gluconate-impregnated PICC (with external clamp)) and one control group ((3) conventional polyurethane PICC (with external clamp)). Recruitment of 1098 adult and paediatric patients will take place over 2 years at three tertiary-referral hospitals in Queensland, Australia. Patients are eligible for inclusion if their PICC is to be inserted for medical treatment, with a vascular size sufficient to support a 4-Fr PICC or larger, and with informed consent. The primary outcome is PICC failure , a composite of thrombotic (venous thrombosis, breakage and occlusion) and infective complications (PICC-associated bloodstream infection and local infection). Secondary outcomes include: all-cause PICC complication; thrombotic complications; infective complications; adverse events (local or systemic reaction); PICC dwell time; patient/parent satisfaction; and healthcare costs. Differences between both intervention groups and the control group will be compared using Cox proportional hazards regression. Effect estimates will be presented as HRs with corresponding 95% CI. ETHICS AND DISSEMINATION Ethical approval from Queensland Health (HREC/QCHQ/48682) and Griffith University (Ref. No. 2019/094). Results will be published. TRIAL REGISTRATION NUMBER ACTRN12619000022167.",2021,"The primary outcome is PICC failure , a composite of thrombotic (venous thrombosis, breakage and occlusion) and infective complications (PICC-associated bloodstream infection and local infection).","['1098 adult and paediatric patients will take place over 2\u2009years at three tertiary-referral hospitals in Queensland, Australia']","['hydrophobic PICC (with pressure-activated valve); (2) chlorhexidine gluconate-impregnated PICC (with external clamp)) and one control group ((3) conventional polyurethane PICC (with external clamp', 'Peripherally inserted central catheters (PICCs']","[' all-cause PICC complication; thrombotic complications; infective complications; adverse events (local or systemic reaction); PICC dwell time; patient/parent satisfaction; and healthcare costs', 'PICC failure , a composite of thrombotic (venous thrombosis, breakage and occlusion) and infective complications (PICC-associated bloodstream infection and local infection']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0034391', 'cui_str': 'Queensland'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0598629', 'cui_str': 'Hydrophobicity'}, {'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0055361', 'cui_str': 'Chlorhexidine gluconate'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0032616', 'cui_str': 'Polyisocyanate'}]","[{'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0429659', 'cui_str': 'Dwell time'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",1098.0,0.368949,"The primary outcome is PICC failure , a composite of thrombotic (venous thrombosis, breakage and occlusion) and infective complications (PICC-associated bloodstream infection and local infection).","[{'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Ullman', 'Affiliation': 'School of Nursing, Midwifery and Social Work, The University of Queensland, St Lucia, Queensland, Australia a.ullman@uq.edu.au.'}, {'ForeName': 'Deanne', 'Initials': 'D', 'LastName': 'August', 'Affiliation': 'School of Nursing, Midwifery and Social Work, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Tricia', 'Initials': 'T', 'LastName': 'Kleidon', 'Affiliation': 'School of Nursing, Midwifery and Social Work, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Walker', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Nathan, Queensland, Australia.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Marsh', 'Affiliation': 'School of Nursing, Midwifery and Social Work, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bulmer', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Nathan, Queensland, Australia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Pearch', 'Affiliation': 'Princess Alexandra Hospital, Metro South Health Service District, Woolloongabba, Queensland, Australia.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Runnegar', 'Affiliation': 'Princess Alexandra Hospital, Metro South Health Service District, Woolloongabba, Queensland, Australia.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Schults', 'Affiliation': 'School of Nursing, Midwifery and Social Work, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Leema', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Nathan, Queensland, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lee-Archer', 'Affiliation': ""Queensland Children's Hospital, Children's Health Queensland Hospital and Health Service, Brisbane, Queensland, Australia.""}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Biles', 'Affiliation': 'Princess Alexandra Hospital, Metro South Health Service District, Woolloongabba, Queensland, Australia.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Southam', 'Affiliation': ""Royal Brisbane and Woman's Hospital, Metro North Health Service District, Herston, Queensland, Australia.""}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Gibson', 'Affiliation': 'School of Nursing, Midwifery and Social Work, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Byrnes', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Nathan, Queensland, Australia.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Ware', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Nathan, Queensland, Australia.'}, {'ForeName': 'Vineet', 'Initials': 'V', 'LastName': 'Chopra', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Nathan, Queensland, Australia.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Coulthard', 'Affiliation': ""Royal Brisbane and Woman's Hospital, Metro North Health Service District, Herston, Queensland, Australia.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Mollee', 'Affiliation': 'Princess Alexandra Hospital, Metro South Health Service District, Woolloongabba, Queensland, Australia.'}, {'ForeName': 'Claire M', 'Initials': 'CM', 'LastName': 'Rickard', 'Affiliation': 'School of Nursing, Midwifery and Social Work, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Patrick N A', 'Initials': 'PNA', 'LastName': 'Harris', 'Affiliation': ""Royal Brisbane and Woman's Hospital, Metro North Health Service District, Herston, Queensland, Australia.""}]",BMJ open,['10.1136/bmjopen-2020-042475'] 3763,33853796,Use of patient-reported outcome measures (PROMs) in clinical diabetes consultations: the DiaPROM randomised controlled pilot trial.,"OBJECTIVE To pilot test the proposed DiaPROM trial components and address uncertainties associated with conducting a full-scale randomised controlled trial (RCT) to evaluate whether such a trial is feasible. DESIGN Two-arm pilot RCT. PARTICIPANTS Adults aged ≥18-39 years, with minimum 1 year type 1 diabetes duration, attending outpatient follow-up. Exclusion criteria were pregnancy, severe cognitive, somatic or psychiatric conditions and impaired vision. RANDOMISATION AND INTERVENTION All participants completed electronic Patient-Reported Outcome Measures (PROMs) prior to the annual diabetes consultation. Using computer-generated block-randomisation without blinding, we assigned participants in a 1:1 ratio stratified by sex to receive standard care or an intervention. Physicians reviewed diabetes distress scores ( Problem Areas In Diabetes scale ) and referred individuals with scores ≥30 or single item(s) ≥3 to minimum two diabetes nurse consultations where reported problems were reviewed and discussed. OUTCOMES Recruitment and retention rates; participants perceptions about intervention components. Variance and estimated between-group differences in follow-up scores ( Diabetes Distress Scale (DDS), WHO 5-Well-being Index , Perceived Competence for Diabetes Scale and glycaemic control ) and DDS correlation with baseline scores, to assist sample size calculations. RESULTS We randomised 80 participants to the control or intervention arm (one participant was later excluded). 23/39 intervention arm participants qualified for additional consultations and 17 attended. 67/79 attended the 12-month follow-up (15.2% attrition); 5/17 referred to additional consultations were lost to follow-up (29.4% attrition). Participants reported PROMs as relevant (84.6%) and acceptable (97.4%) but rated the usefulness of consultations as moderate to low. Baseline mean±SD DDS score was 2.1±0.69; DDS SD was 0.71 (95% CI: 0.60 to 0.86) at follow-up; correlation between baseline and follow-up DDS scores was 0.8 (95% CI: 0.7 to 0.9). CONCLUSIONS The pilot trial revealed need for intervention modifications ahead of a full-scale trial to evaluate use of PROMs in diabetes consultations. Specifically, participant acceptability and intervention implementation need further investigation.",2021,"Variance and estimated between-group differences in follow-up scores ( Diabetes Distress Scale (DDS), WHO 5-Well-being Index , Perceived Competence for Diabetes Scale and glycaemic control ) and DDS correlation with baseline scores, to assist sample size calculations. ","['80 participants to the control or intervention arm (one participant was later excluded', 'In Diabetes scale ) and referred individuals with scores ≥30\u2009or single item(s) ≥3\u2009to minimum two diabetes nurse consultations where reported problems were reviewed and discussed', 'Adults aged ≥18-39 years, with minimum 1\u2009year type 1 diabetes duration, attending outpatient follow-up']",[],"['DDS score', 'follow-up scores ( Diabetes Distress Scale (DDS), WHO 5-Well-being Index , Perceived Competence for Diabetes Scale and glycaemic control ) and DDS correlation with baseline scores', 'diabetes distress scores ( Problem Areas', 'pregnancy, severe cognitive, somatic or psychiatric conditions and impaired vision']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",[],"[{'cui': 'C0010980', 'cui_str': 'Dapsone'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C3665347', 'cui_str': 'Visual impairment'}]",,0.467302,"Variance and estimated between-group differences in follow-up scores ( Diabetes Distress Scale (DDS), WHO 5-Well-being Index , Perceived Competence for Diabetes Scale and glycaemic control ) and DDS correlation with baseline scores, to assist sample size calculations. ","[{'ForeName': 'Ingvild', 'Initials': 'I', 'LastName': 'Hernar', 'Affiliation': 'Department of Health and Caring Sciences, Western Norway University of Applied Sciences, Bergen, Norway ingvild.hernar@hvl.no.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Graue', 'Affiliation': 'Department of Health and Caring Sciences, Western Norway University of Applied Sciences, Bergen, Norway.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Richards', 'Affiliation': 'Department of Health and Caring Sciences, Western Norway University of Applied Sciences, Bergen, Norway.'}, {'ForeName': 'Ragnhild B', 'Initials': 'RB', 'LastName': 'Strandberg', 'Affiliation': 'Department of Health and Caring Sciences, Western Norway University of Applied Sciences, Bergen, Norway.'}, {'ForeName': 'Roy Miodini', 'Initials': 'RM', 'LastName': 'Nilsen', 'Affiliation': 'Faculty of Health and Social Sciences, Western Norway University of Applied Sciences, Bergen, Norway.'}, {'ForeName': 'Magne', 'Initials': 'M', 'LastName': 'Rekdal', 'Affiliation': 'Dips AS, Bergen, Norway.'}, {'ForeName': 'Karianne Fjeld', 'Initials': 'KF', 'LastName': 'Løvaas', 'Affiliation': 'Norwegian Diabetes Register for Adults, Norwegian Organisation for Quality Improvement of Laboratory Examinations (Noklus), Haraldsplass Deaconess Hospital, Bergen, Norway.'}, {'ForeName': 'Tone V', 'Initials': 'TV', 'LastName': 'Madsen', 'Affiliation': 'Norwegian Diabetes Register for Adults, Norwegian Organisation for Quality Improvement of Laboratory Examinations (Noklus), Haraldsplass Deaconess Hospital, Bergen, Norway.'}, {'ForeName': 'Grethe S', 'Initials': 'GS', 'LastName': 'Tell', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Haugstvedt', 'Affiliation': 'Department of Health and Caring Sciences, Western Norway University of Applied Sciences, Bergen, Norway.'}]",BMJ open,['10.1136/bmjopen-2020-042353'] 3764,33853794,Estimation of overdiagnosis in colorectal cancer screening with sigmoidoscopy and faecal occult blood testing: comparison of simulation models.,"OBJECTIVE To estimate overdiagnosis of colorectal cancer (CRC) for screening with sigmoidoscopy and faecal occult blood testing (FOBT). DESIGN Simulation study using data from randomised trials. SETTING Primary screening, UK, Norway PARTICIPANTS: 152 850 individuals from the Nottingham trial and 98 678 individuals from the Norwegian Colorectal Cancer Prevention (NORCCAP) trial. INTERVENTION CRC screening. OUTCOME MEASURE We estimated overdiagnosis using long-term data from two randomised trials: the Nottingham trial comparing FOBT screening every other year to no-screening, and the NORCCAP trial comparing once-only sigmoidoscopy screening to no-screening. To estimate the natural growth of adenomas to CRC, we used the following microsimulation models: (i) the Microsimulation Screening Analysis; (ii) the CRC Simulated Population model for Incidence and Natural history; (iii) the Simulation Model of Colorectal Cancer; (iv) a model derived by the German Cancer Research Center. We defined overdiagnosed cancers as the difference between the observed number of CRCs in the no-screening arm and the expected number of cancers in screening arm (sum of observed and prevented by adenoma removal). The amount of overdiagnosis is defined as the number of overdiagnosed cancers over the number of cancers observed in the no-screening arm. RESULTS Overdiagnosis estimates were highly dependent on model assumptions. For FOBT screening with 2354 cancers observed in control arm, four out of five models predicted overdiagnosis, range 2.0% (2400 cancers expected in screening) to 7.6% (2533 cancers expected in screening). For sigmoidoscopy screening with 452 cancers observed in control arm, all models predicted overdiagnosis, range 25.2% (566 cancers expected in screening) to 128.1% (1031 cancers expected in screening). CONCLUSIONS The amount of overdiagnosis estimated based on the microsimulation models varied substantially. Microsimulation models may not give reliable estimates of the preventive effect of adenoma removal, and should be used with caution to inform guidelines.",2021,"Microsimulation models may not give reliable estimates of the preventive effect of adenoma removal, and should be used with caution to inform guidelines.",[' 152\u2009850 individuals from the Nottingham trial and 98\u2009678 individuals from the Norwegian Colorectal Cancer Prevention (NORCCAP) trial'],[],[],"[{'cui': 'C3840657', 'cui_str': '850'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]",[],[],152850.0,0.06721,"Microsimulation models may not give reliable estimates of the preventive effect of adenoma removal, and should be used with caution to inform guidelines.","[{'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Wieszczy', 'Affiliation': 'Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Michal F', 'Initials': 'MF', 'LastName': 'Kaminski', 'Affiliation': 'Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Løberg', 'Affiliation': 'Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Bugajski', 'Affiliation': 'Department of Gastroenterology, Hepatology and Clinical Oncology, Centre of Postgraduate Medical Education, Warsaw, Poland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bretthauer', 'Affiliation': 'Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Kalager', 'Affiliation': 'Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo, Norway mkalager@hsph.harvard.edu.'}]",BMJ open,['10.1136/bmjopen-2020-042158'] 3765,33853792,Efficacy of the iDBT-Pain skills training intervention to reduce emotional dysregulation and pain intensity in people with chronic pain: protocol for a single-case experimental design with multiple baselines.,"INTRODUCTION Difficulties in emotional regulation are key to the development and maintenance of chronic pain. Recent evidence shows internet-delivered dialectic behaviour therapy (iDBT) skills training can reduce emotional dysregulation and pain intensity. However, further studies are needed to provide more definitive evidence regarding the efficacy of iDBT skills training in the chronic pain population. METHODS AND ANALYSIS A single-case experimental design (SCED) with multiple baselines will be used to examine the efficacy of a 4-week iDBT-Pain skills training intervention (iDBT-Pain intervention) to reduce emotional dysregulation and pain intensity in individuals with chronic pain. The iDBT-Pain intervention encompasses two components: (1) iDBT-Pain skills training sessions (iDBT-Pain sessions) and (2) the iDBT-Pain skills training web application (iDBT-Pain app). Three individuals with chronic pain will be recruited and randomly allocated to different baseline phases (5, 9 or 12 days). Following the baseline phase, participants will receive six 60-90 min iDBT-Pain sessions approximately 4 or 5 days apart, delivered by a psychologist via Zoom. To reinforce learnings from the iDBT-Pain sessions, participants will have unlimited use of the iDBT-Pain app. A 7-day follow-up phase (maintenance) will follow the intervention, whereby the iDBT-Pain sessions cease but the iDBT-Pain app is accessible. Emotional regulation, as the primary outcome measure, will be assessed using the Difficulties in Emotion Regulation Scale. Pain intensity, as the secondary outcome measure, will be assessed using a visual analogue scale. Generalisation measures will assess psychological state factors (depression, anxiety and coping behaviour), alongside sleep quality, well-being and harm avoidance. SCEDs are increasingly considered effective designs for internet-delivered psychological interventions because SCED enables the investigation of interindividual variability in a heterogeneous population such as chronic pain. ETHICS AND DISSEMINATION This trial was approved by the University of New South Wales (HC200199). Results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER ACTRN12620000604909.",2021,"SCEDs are increasingly considered effective designs for internet-delivered psychological interventions because SCED enables the investigation of interindividual variability in a heterogeneous population such as chronic pain. ","['people with chronic pain', 'Three individuals with chronic pain', 'individuals with chronic pain']","['iDBT skills training', 'iDBT-Pain skills training intervention', 'dialectic behaviour therapy (iDBT) skills training', 'iDBT-Pain skills training intervention (iDBT-Pain intervention']","['psychological state factors (depression, anxiety and coping behaviour), alongside sleep quality, well-being and harm avoidance', 'Pain intensity', 'emotional dysregulation and pain intensity', 'Difficulties in Emotion Regulation Scale', 'Emotional regulation', 'visual analogue scale']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0679771', 'cui_str': 'Harm Minimization'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",3.0,0.0880865,"SCEDs are increasingly considered effective designs for internet-delivered psychological interventions because SCED enables the investigation of interindividual variability in a heterogeneous population such as chronic pain. ","[{'ForeName': 'Nell', 'Initials': 'N', 'LastName': 'Norman-Nott', 'Affiliation': 'Centre for Pain IMPACT, Neuroscience Research Australia, Randwick, New South Wales, Australia.'}, {'ForeName': 'Chelsey', 'Initials': 'C', 'LastName': 'Wilks', 'Affiliation': 'Department of Psychological Science, University of Missouri-St Louis, St Louis, Missouri, USA.'}, {'ForeName': 'Negin', 'Initials': 'N', 'LastName': 'Hesam-Shariati', 'Affiliation': 'Centre for Pain IMPACT, Neuroscience Research Australia, Randwick, New South Wales, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Schroeder', 'Affiliation': 'School of Computer Science and Engineering, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Jina', 'Initials': 'J', 'LastName': 'Suh', 'Affiliation': 'School of Computer Science and Engineering, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Czerwinski', 'Affiliation': 'Microsoft Research, Redmond, Washington, USA.'}, {'ForeName': 'Sylvia Maria', 'Initials': 'SM', 'LastName': 'Gustin', 'Affiliation': 'Centre for Pain IMPACT, Neuroscience Research Australia, Randwick, New South Wales, Australia s.gustin@unsw.edu.au.'}]",BMJ open,['10.1136/bmjopen-2020-041745'] 3766,33853731,Almond Bioaccessibility in a Randomized Crossover Trial: Is a Calorie a Calorie?,"OBJECTIVE To investigate the energy and macronutrient bioaccessibility of almonds in individuals with hyperlipidemia. METHODS In a previously reported randomized crossover trial, men and postmenopausal women with hyperlipidemia incorporated 3 isoenergetic supplements into a National Cholesterol Education Program Step 2 diet for 1 month each between September 20, 2000, and June 27, 2001. Supplements provided consisted of full-dose almonds (73±5 g/d), half-dose almonds (38±3 g/d) plus half-dose muffins, and full-dose muffins (control). Energy and macronutrients, including individual fatty acids, were measured in the dietary supplements and fecal samples using gas chromatography and Association of Official Analytical Chemists methods. Serum was measured for lipids and fatty acids. Bioaccessibility of energy and macronutrients from almond consumption was assessed from dietary intake (7-day food records) and fecal output. RESULTS Almond-related energy bioaccessibility was 78.5%±3.1%, with an average energy loss of 21.2%±3.1% (40.6 kcal/d in the full-dose almond phase). Bioaccessibility of energy and fat from the diet as a whole was significantly less with almond consumption (in both half- and full-dose phases) compared with the control. Bioaccessibility of fat was significantly different between treatment phases (P<.001) and on average lower by 5.1% and 6.3% in the half- and full-dose almond phases, respectively, compared with the control phase. Energy bioaccessibility was significantly different between the treatment phases (P=.02), decreasing by approximately 2% with the inclusion of the full dose of almonds compared with the control. CONCLUSION Energy content of almonds may not be as bioaccessible in individuals with hyperlipidemia as predicted by Atwater factors, as suggested by the increased fat excretion with almond intake compared with the control. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT00507520.",2021,"Energy bioaccessibility was significantly different between the treatment phases (P=.02), decreasing by approximately 2% with the inclusion of the full dose of almonds compared with the control. ","['individuals with hyperlipidemia', 'men and postmenopausal women with hyperlipidemia incorporated 3 isoenergetic supplements into a National Cholesterol Education Program Step 2 diet for 1 month each between September 20, 2000, and June 27, 2001']",[],"['Energy bioaccessibility', 'Bioaccessibility of fat', 'Bioaccessibility of energy and fat', 'energy bioaccessibility']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0470277', 'cui_str': '2000'}]",[],"[{'cui': 'C0015677', 'cui_str': 'Fat'}]",,0.0796843,"Energy bioaccessibility was significantly different between the treatment phases (P=.02), decreasing by approximately 2% with the inclusion of the full dose of almonds compared with the control. ","[{'ForeName': 'Stephanie K', 'Initials': 'SK', 'LastName': 'Nishi', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Ontario, Canada; Toronto 3D (Diet, Digestive Tract and Disease) Knowledge Synthesis and Clinical Trials Unit, Ontario, Canada; Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, Ontario, Canada. Electronic address: https://twitter.com/@steph.nishi.""}, {'ForeName': 'Cyril W C', 'Initials': 'CWC', 'LastName': 'Kendall', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Ontario, Canada; Toronto 3D (Diet, Digestive Tract and Disease) Knowledge Synthesis and Clinical Trials Unit, Ontario, Canada; Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, Ontario, Canada; College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, Canada.""}, {'ForeName': 'Richard P', 'Initials': 'RP', 'LastName': 'Bazinet', 'Affiliation': 'Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Ontario, Canada.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Hanley', 'Affiliation': 'Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Ontario, Canada; Dalla Lana School of Public Health, University of Toronto, Ontario, Canada; Department of Medicine, University of Toronto, Ontario, Canada.'}, {'ForeName': 'Elena M', 'Initials': 'EM', 'LastName': 'Comelli', 'Affiliation': 'Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Ontario, Canada; Joannah and Brian Lawson Centre for Child Nutrition, University of Toronto, Ontario, Canada.'}, {'ForeName': 'David J A', 'Initials': 'DJA', 'LastName': 'Jenkins', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Ontario, Canada; Department of Medicine, University of Toronto, Ontario, Canada; Toronto 3D (Diet, Digestive Tract and Disease) Knowledge Synthesis and Clinical Trials Unit, Ontario, Canada; Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, Ontario, Canada; Division of Endocrinology & Metabolism, St. Michael's Hospital, Toronto, Ontario, Canada; Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Sievenpiper', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Ontario, Canada; Department of Medicine, University of Toronto, Ontario, Canada; Toronto 3D (Diet, Digestive Tract and Disease) Knowledge Synthesis and Clinical Trials Unit, Ontario, Canada; Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, Ontario, Canada; Division of Endocrinology & Metabolism, St. Michael's Hospital, Toronto, Ontario, Canada; Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada. Electronic address: john.sievenpiper@utoronto.ca.""}]",Mayo Clinic proceedings,['10.1016/j.mayocp.2021.01.026'] 3767,33853721,"Repetitive deep TMS for the reduction of body weight: Bimodal effect on the functional brain connectivity in ""diabesity"".","BACKGROUND AND AIMS Deep repetitive Transcranial Magnetic Stimulation (deep rTMS) over the bilateral insula and prefrontal cortex (PFC) can promote weight-loss in obesity, preventing cardiometabolic complications as Type 2 Diabetes (T2D). To investigate the changes in the functional brain integration after dTMS, we conducted a resting-state functional connectivity (rsFC) study in obesity. METHODS AND RESULTS This preliminary study was designed as a randomized, double-blind, sham-controlled study: 9 participants were treated with high-frequency stimulation (realTMS group), 8 were sham-treated (shamTMS group). Out of the 17 enrolled patients, 6 were affected by T2D. Resting-state fMRI scans were acquired at baseline (T0) and after the 5-week intervention (T1). Body weight was measured at three time points [T0, T1, 1-month follow-up visit (FU1)]. A mixed-model analysis showed a significant group-by-time interaction for body weight (p = .04), with a significant decrease (p < .001) in the realTMS group. The rsFC data revealed a significant increase of degree centrality for the realTMS group in the medial orbitofrontal cortex (mOFC) and a significant decrease in the occipital pole. CONCLUSION An increase of whole-brain functional connections of the mOFC, together with the decrease of whole-brain functional connections with the occipital pole, may reflect a brain mechanism behind weight-loss through a diminished reactivity to bottom-up visual-sensory processes in favor of increased reliance on top-down decision-making processes. TRIAL REGISTRATION NUMBER ClinicalTrials.gov NCT03009695.",2021,"A mixed-model analysis showed a significant group-by-time interaction for body weight (p = .04), with a significant decrease (p < .001) in the realTMS group.",[],"['Deep repetitive Transcranial Magnetic Stimulation (deep rTMS', 'high-frequency stimulation (realTMS group), 8 were sham-treated (shamTMS', 'Repetitive deep TMS']","['body weight', 'degree centrality', 'Body weight']",[],"[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",17.0,0.0771764,"A mixed-model analysis showed a significant group-by-time interaction for body weight (p = .04), with a significant decrease (p < .001) in the realTMS group.","[{'ForeName': 'Francantonio', 'Initials': 'F', 'LastName': 'Devoto', 'Affiliation': 'Department of Psychology and PhD Program in Neuroscience of the School of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ferrulli', 'Affiliation': 'Department of Biomedical Sciences for Health, Università Degli Studi di Milano, Milan, Italy; Department of Endocrinology, Nutrition and Metabolic Diseases, IRCCS MultiMedica, Sesto San Giovanni, MI, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Zapparoli', 'Affiliation': 'Department of Psychology, University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Massarini', 'Affiliation': 'Department of Endocrinology, Nutrition and Metabolic Diseases, IRCCS MultiMedica, Sesto San Giovanni, MI, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Banfi', 'Affiliation': 'IRCCS Orthopedic Institute Galeazzi, Milan, Italy.'}, {'ForeName': 'Eraldo', 'Initials': 'E', 'LastName': 'Paulesu', 'Affiliation': 'Department of Psychology, University of Milano-Bicocca, Milan, Italy; IRCCS Orthopedic Institute Galeazzi, Milan, Italy.'}, {'ForeName': 'Livio', 'Initials': 'L', 'LastName': 'Luzi', 'Affiliation': 'Department of Biomedical Sciences for Health, Università Degli Studi di Milano, Milan, Italy; Department of Endocrinology, Nutrition and Metabolic Diseases, IRCCS MultiMedica, Sesto San Giovanni, MI, Italy. Electronic address: livio.luzi@multimedica.it.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2021.02.015'] 3768,33853718,Ultra Rapid-Acting Inhaled Insulin Improves Glucose Control in Patients With Type 2 Diabetes Mellitus.,"OBJECTIVE To determine whether the use of an inhaled insulin would improve HbA1c. METHODS This study was performed in 20 type 2 diabetes mellitus (T2DM) participants with HbA1c values ≥7.5 (58) to ≤11.5% (102 mmol/mol) on a variety of glucose-lowering regimens. Prandial Technosphere insulin (TI) was rapidly titrated based on a treatment algorithm using postprandial blood glucose to calculate premeal doses. A 2-week baseline period was followed by 12 weeks of active treatment with TI. The primary outcome was change in HbA1c. Secondary outcomes included glucose time in range (time in range: 70-180 mg/dL) obtained by a blinded continuous glucose monitoring during the baseline period and at the end of 12 weeks. Goals were to assess how to rapidly and safely initiate TI intensification, determine dosing requirements, and establish an effective dose range in uncontrolled T2DM. RESULTS Mean HbA1c decreased by -1.6% (-17 mmol/mol) from 9.0% (75 mmol/mol) at baseline to 7.4% (57 mmol/mol) at 12 weeks (P < .0001). Mean time in range increased from 42.2% to 65.7% (P < .0002). Mean prandial doses of TI were 18 or 19 units for all meals. Time below range was 1.1% baseline and 2.6% post treatment (P = .01). CONCLUSION Treatment with inhaled TI dosed using a simple algorithm improved glycemic control measured by both HbA1c and time in range, with low rates of hypoglycemia. These data add significantly to understanding TI in the management of T2DM patients for whom prandial insulin is a consideration.",2020,Mean time in range increased from 42.2% to 65.7% (P < .0002).,"['20 type 2 diabetes mellitus (T2DM) participants with HbA1c values ≥7.5 (58) to ≤11.5% (102 mmol/mol) on a variety of glucose-lowering regimens', 'Patients With Type 2 Diabetes Mellitus']","['Ultra Rapid-Acting Inhaled Insulin', 'Prandial Technosphere insulin (TI', 'inhaled insulin']","['glucose time in range (time in range: 70-180 mg/dL', 'Mean prandial doses of TI', 'change in HbA1c', 'glycemic control', 'Mean time in range', 'Mean HbA1c']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0842894,Mean time in range increased from 42.2% to 65.7% (P < .0002).,"[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Levin', 'Affiliation': 'MODEL Clinical Research, Endocrinology, Baltimore, Maryland. Electronic address: pal3420@yahoo.com.'}, {'ForeName': 'Byron J', 'Initials': 'BJ', 'LastName': 'Hoogwerf', 'Affiliation': 'Emeritus, Endocrinology, Diabetes and Metabolism, Cleveland Clinic, Cleveland, Ohio; Central Michigan University, Mount Pleasant, Michigan.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Snell-Bergeon', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Pediatrics, Aurora, Colorado; Colorado School of Public Health, Department of Biostatistics and Informatics, Aurora, Colorado.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Vigers', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Pediatrics, Aurora, Colorado; Colorado School of Public Health, Department of Biostatistics and Informatics, Aurora, Colorado.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pyle', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Pediatrics, Aurora, Colorado; Colorado School of Public Health, Department of Biostatistics and Informatics, Aurora, Colorado.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Bromberger', 'Affiliation': 'MODEL Clinical Research, Endocrinology, Baltimore, Maryland.'}]",Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists,['10.1016/j.eprac.2020.10.004'] 3769,33853701,"Cognitive remediation and professional insertion of people with schizophrenia: RemedRehab , a randomized controlled trial.",,2021,,['people with schizophrenia'],['Cognitive remediation and professional insertion'],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",[],,0.324824,,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cervello', 'Affiliation': 'Psychosocial rehabilitation Resource Center (CRR) and reference center (SUR-CL3R), Le Vinatier Hospital, Lyon, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dubreucq', 'Affiliation': 'Psychosocial Rehabilitation Reference Centre, Alpes Isère Hospital, Grenoble, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Trichanh', 'Affiliation': 'Psychosocial rehabilitation Resource Center (CRR) and reference center (SUR-CL3R), Le Vinatier Hospital, Lyon, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dubrulle', 'Affiliation': 'Psychosocial rehabilitation Resource Center (CRR) and reference center (SUR-CL3R), Le Vinatier Hospital, Lyon, France.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Amado', 'Affiliation': 'Service hospitalo-universitaire, CJAAD, centre hospitalier Sainte-Anne, 75014Paris, France; Faculté de médecine, université Paris Descartes, Sorbonne Paris Cité, 75006Paris, France; Inserm, laboratoire de « physiopathologie des maladies psychiatriques », centre de psychiatrie et neurosciences, U894, institut de psychiatrie (GDR3557), 75014Paris, France; Service hospitalo-universitaire, C3RP, centre hospitalier Sainte-Anne, 75014Paris, France. i.amado@ch-sainte-anne.fr.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Bralet', 'Affiliation': ""Crisalid Unit (FJ5), CHI Clermont de l'Oise, 2 rue des Finets, 60607, Clermont, France.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Chirio-Espitalier', 'Affiliation': ""Pôle de psychiatrie et santé mentale, Centre de référence en soins d'éducation thérapeutique et remédiation cognitive (CReSERC), centre hospitalier universitaire, 85, rue Saint-Jacques, 44093Nantes cedex, France.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Delille', 'Affiliation': 'Département de Réhabilitation Psychosociale et de remédiation cognitive, Lille, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Fakra', 'Affiliation': 'University Department of Psychiatry, Centre Hospitalier Universitaire de Saint Etienne, Saint Etienne, France; INSERM, U1028; CNRS, UMR5292; CRNL (Lyon Neuroscience Research Center), PSYR2 Team, Lyon, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Francq', 'Affiliation': 'CREST (Center of Research in\xa0Economics and Statistics), UMR 9194, Palaiseau, France.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Guillard-Bouhet', 'Affiliation': 'CREATIV & URC Pierre Deniker, Centre Hospitalier Laborit, Poitiers, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Graux', 'Affiliation': 'Se rétablir 37, CHRU de Tours, UMR 1253,\xa0iBrain, Université\xa0de Tours, Inserm, Tours, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lançon', 'Affiliation': 'CEReSS, Université de la mediteranée, Marseille.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Zakoian', 'Affiliation': 'CREST (Center of Research in\xa0Economics and Statistics), UMR 9194, Palaiseau, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Gauthier', 'Affiliation': 'Psychosocial rehabilitation Resource Center (CRR) and reference center (SUR-CL3R), Le Vinatier Hospital, Lyon, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Demily', 'Affiliation': 'GénoPsy, Reference Center for Diagnosis and Management of Genetic Psychiatric Disorders, Centre Hospitalier le Vinatier and EDR-Psy Q19 Team (Centre National de la Recherche Scientifique & Lyon 1 Claude Bernard University), 69678Bron, France.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Franck', 'Affiliation': 'Psychosocial rehabilitation Resource Center (CRR) and reference center (SUR-CL3R), Le Vinatier Hospital, Lyon, France.'}]",European psychiatry : the journal of the Association of European Psychiatrists,['10.1192/j.eurpsy.2021.25'] 3770,33853684,Why participation in an international clinical trial platform matters during a pandemic? Launching REMAP-CAP in Japan.,"REMAP-CAP, a randomized, embedded, multifactorial adaptive platform trial for community-acquired pneumonia, is an international clinical trial that is rapidly expanding its scope and scale in response to the COVID-19 pandemic. Japan is now joining REMAP-CAP with endorsement from Japanese academic societies. Commitment to REMAP-CAP can significantly contribute to population health through timely identification of optimal COVID-19 therapeutics. Additionally, it will promote the establishment of a national and global network of clinical trials to tackle future pandemics of emerging and re-emerging infectious diseases, in collaboration with multiple stakeholders, including front-line healthcare workers, governmental agencies, regulatory authorities, and academic societies.",2021,"REMAP-CAP, a randomized, embedded, multifactorial adaptive platform trial for community-acquired pneumonia, is an international clinical trial that is rapidly expanding its scope and scale in response to the COVID-19 pandemic.",[],['REMAP-CAP'],[],[],"[{'cui': 'C0006935', 'cui_str': 'Capsule'}]",[],,0.154668,"REMAP-CAP, a randomized, embedded, multifactorial adaptive platform trial for community-acquired pneumonia, is an international clinical trial that is rapidly expanding its scope and scale in response to the COVID-19 pandemic.","[{'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Kamata', 'Affiliation': 'Department of General Internal Medicine, Aizu Medical Center, Fukushima Medical University, 21-2 Maeda, Kawahigashimachi Tanisawa, Aizuwakamatsu-city, Fukushima, 969-3492, Japan.'}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Jindai', 'Affiliation': 'Department of Healthcare Epidemiology, School of Public Health, Kyoto University, Yoshida-konoe-cho, Sakyo-Ku, Kyoto-city, Kyoto, 606-8501, Japan. jindai.kazuaki.z15@kyoto-u.jp.'}, {'ForeName': 'Nao', 'Initials': 'N', 'LastName': 'Ichihara', 'Affiliation': 'Department of Healthcare Quality Assessment, Graduate School of Medicine, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Saito', 'Affiliation': 'Department of Emergency and Critical Care Medicine, St. Marianna University School of Medicine, Yokohama City Seibu Hospital, 1197-1 Yasashicho, Asahi-ku, Yokohama-city, Kanagawa, 241-0811, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Kato', 'Affiliation': 'Infection Prevention and Control Department, Yokohama City University Hospital, 3-9 Fukuura, Kanazawa-ku, Yokohama-city, Kanagawa, 236-0004, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kunishima', 'Affiliation': 'Department of Infectious Diseases, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki-city, Kanagawa, 216-8511, Japan.'}, {'ForeName': 'Ayumi', 'Initials': 'A', 'LastName': 'Shintani', 'Affiliation': 'Department of Medical Statistics, Graduate School of Medicine, Osaka City University, 1-4-3 Asahi-machi, Abeno-ku, Osaka-City, Osaka, 545-0051, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Nishida', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, School of Medicine, Fujita Health University, 1-98 Dengakugakubo, Kutsukake-cho, Toyoake-city, Aichi, 470-1192, Japan.'}, {'ForeName': 'Shigeki', 'Initials': 'S', 'LastName': 'Fujitani', 'Affiliation': 'Department of Emergency and Critical Care Medicine, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki-city, Kanagawa, 216-8511, Japan.'}]",Journal of intensive care,['10.1186/s40560-021-00547-7'] 3771,33853682,Graded activity with and without daily-monitored-walking in patients with type 2 diabetes with low back pain: secondary analysis of a randomized-clinical trial.,"BACKGROUND Graded activity is gradually emerging as a preferred choice in improving psychosocial outcomes including pain self-efficacy, fear-avoidance beliefs, and back-pain beliefs in the general population with low back pain (LBP). Such evidence is, however, lacking among patients with concomitant LBP and type-2 diabetes mellitus (T2DM). This secondary analysis of a randomized control trial aimed to compare the efficacy between graded activity augmented with additional daily-monitored-walking and graded activity alone on disability, pain self-efficacy (PSE), fear-avoidance beliefs (FAB), back-pain beliefs (BPB) and glycaemic control (HbA1c) in patients with concomitant LBP and T2DM. METHODS Fifty-eight patients with concomitant LBP and T2DM were randomised into two groups, graded activity with daily-monitored-walking group (GAMWG = 29) or (graded activity group (GAG = 29) in this 12-week single-blind trial. Both groups received graded activity (home/work-place visits, back school and sub-maximal exercises) while the GAMWG received additional daily-monitored-walking. Disability and selected psychosocial outcomes were assessed at weeks 0, 4, 8 and 12 using Roland-Morris disability, fear-avoidance behaviour, pain self-efficacy and back belief questionnaires. Glycaemic control was assessed at weeks 0 and 12 using a point-of-care system (In2it, Biorad Latvia). Data were analysed using mean, median, Friedman's ANOVA, Mann-Whitney test and t-tests. RESULTS Participants' mean age was 48.3 ± 9.4 years (95%CI: 45.6, 50.9) while 35.3% were males. The GAMWG participants (n = 25) had better outcomes (P < 0.05) than GAG participants (n = 26) on PSE (1.0, 3.0; r = - 0.1) and FAB (0.01, - 2.0; r = - 0.1) at week 4, LBP-related disability (0.01, - 2.0; r = - 0.2) at week 8 and glycaemic control at week 12 (- 0.59 ± 0.51%,-0.46 ± 0.22%). No other between-group comparisons were statistically significant. CONCLUSION Graded activity with daily-monitored-walking provided earlier improvements on disability, pain self-efficacy, fear-avoidance beliefs, and glycaemic control, but not back pain beliefs, in patients with concomitant LBP and T2DM. TRIAL REGISTRATION PACTR201702001728564 ; 26 July, 2016 (retrospectively registered).",2021,"Graded activity with daily-monitored-walking provided earlier improvements on disability, pain self-efficacy, fear-avoidance beliefs, and glycaemic control, but not back pain beliefs, in patients with concomitant LBP and T2DM. ","['patients with concomitant LBP and T2DM', ""Participants' mean age was 48.3\u2009±\u20099.4\u2009years (95%CI: 45.6, 50.9) while 35.3% were males"", 'Fifty-eight patients with concomitant LBP and T2DM', 'patients with concomitant LBP and type-2 diabetes mellitus (T2DM', 'general population with low back pain (LBP', 'patients with type 2 diabetes with low back pain']","['graded activity with daily-monitored-walking group (GAMWG\u2009=\u200929) or (graded activity group (GAG\u2009=\u200929', 'graded activity (home/work-place visits, back school and sub-maximal exercises) while the GAMWG received additional daily-monitored-walking', 'graded activity augmented with additional daily-monitored-walking and graded activity alone', 'Graded activity with and without daily-monitored-walking']","['Glycaemic control', 'Disability and selected psychosocial outcomes', 'disability, pain self-efficacy, fear-avoidance beliefs, and glycaemic control, but not back pain beliefs', 'Roland-Morris disability, fear-avoidance behaviour, pain self-efficacy and back belief questionnaires', 'LBP-related disability', 'disability, pain self-efficacy (PSE), fear-avoidance beliefs (FAB), back-pain beliefs (BPB) and glycaemic control (HbA1c']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0016927', 'cui_str': 'Gagging'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0178494', 'cui_str': 'Avoidance behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",58.0,0.118243,"Graded activity with daily-monitored-walking provided earlier improvements on disability, pain self-efficacy, fear-avoidance beliefs, and glycaemic control, but not back pain beliefs, in patients with concomitant LBP and T2DM. ","[{'ForeName': 'Opeyemi Ayodiipo', 'Initials': 'OA', 'LastName': 'Idowu', 'Affiliation': 'Department of Physiotherapy, College of Medical Sciences, School of Basic Medical Sciences, University of Benin, Benin City, Nigeria. opeyemi.idowu@uniben.edu.'}, {'ForeName': 'Ade Fatai', 'Initials': 'AF', 'LastName': 'Adeniyi', 'Affiliation': 'Department of Physiotherapy, College of Medicine, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Edo', 'Affiliation': 'Deparment of Medicine, University of Benin, Benin City, Nigeria.'}, {'ForeName': 'Adesoji', 'Initials': 'A', 'LastName': 'Fasanmade', 'Affiliation': 'Department of Physiology, College of Medicine, University of Ibadan, Ibadan, Nigeria.'}]",Archives of physiotherapy,['10.1186/s40945-021-00104-3'] 3772,33853650,Bedside Ultrasound Conducted in Kids with distal upper Limb fractures in the Emergency Department (BUCKLED): a protocol for an open-label non-inferiority diagnostic randomised controlled trial.,"BACKGROUND Children frequently present to the emergency department (ED) with forearm injuries and often have x-rays to determine if there is a fracture. Bedside ultrasound, also known as point-of-care ultrasound (POCUS), is an alternative diagnostic test used to rapidly diagnose a fracture at the time of examination, without exposing children to ionising radiation. Prospective studies have demonstrated high agreement between POCUS and x-ray findings. However, whether the initial imaging modality affects the patient's medium-term physical function is unknown. METHODS This is a multicentre, open-label, non-inferiority randomised controlled trial conducted in Australian EDs. Recruitment will continue until 112 children with distal forearm injuries (including 48 buckle fractures) per trial arm have achieved the primary outcome measure. Patients aged 5-15 years presenting with an isolated, acute, clinically non-angulated, distal forearm injury with suspected fracture will have their initial diagnostic approach randomised to either POCUS, performed by a credentialled practitioner, or x-ray imaging. If a cortical breach fracture is identified on POCUS, the patient will receive x-rays and have usual care. If a buckle fracture is identified, the patient will have their forearm placed in a splint and be discharged home. Patients will be followed up at 1, 4 and 8 weeks. The primary outcome is upper limb physical function at 4 weeks, as determined by the Pediatric Upper Extremity Short Patient-Reported Outcomes Measurement Information System (PROMIS) tool. Secondary outcomes include healthcare costs, satisfaction, pain, complications, rates of imaging, ED length of stay and diagnostic accuracy. DISCUSSION If POCUS is non-inferior to x-ray in terms of patient's medium-term physical function, it may have an effect on overall health care resource use, including the number of x-ray performed and earlier ED discharge. Although prospective studies have confirmed the accuracy of POCUS, this will be the first RCT to assess non-inferiority of functional outcomes of POCUS to diagnose non-angulated paediatric distal forearm injuries, compared to x-ray. POCUS may be of particular importance in settings where access to x-ray imaging can be limited either during or after-hours, as it can aid the triaging and management of patients. TRIAL REGISTRATION Prospectively registered with the ANZCTR on 29 May 2020 ( ACTRN12620000637943 ).",2021,"Bedside ultrasound, also known as point-of-care ultrasound (POCUS), is an alternative diagnostic test used to rapidly diagnose a fracture at the time of examination, without exposing children to ionising radiation.","['112 children with distal forearm injuries (including 48 buckle fractures', 'Patients aged 5-15\u2009years presenting with an isolated, acute, clinically non-angulated, distal forearm injury with suspected fracture will have their initial diagnostic approach randomised to either POCUS, performed by a credentialled practitioner, or x-ray imaging', 'Kids with distal upper Limb fractures in the Emergency Department (BUCKLED']",[],"['healthcare costs, satisfaction, pain, complications, rates of imaging, ED length of stay and diagnostic accuracy', 'upper limb physical function at 4\u2009weeks, as determined by the Pediatric Upper Extremity Short Patient-Reported Outcomes Measurement Information System (PROMIS) tool']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0016537', 'cui_str': 'Injury of forearm'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0347847', 'cui_str': '[Q] Buckle'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0333179', 'cui_str': 'Angulated'}, {'cui': 'C3494743', 'cui_str': 'Suspected fracture of bone'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0043299', 'cui_str': 'X-Ray, Diagnostic'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0178316', 'cui_str': 'Fracture of upper limb'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0231748', 'cui_str': 'Giving-way'}]",[],"[{'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021428', 'cui_str': 'Information system'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]",112.0,0.146355,"Bedside ultrasound, also known as point-of-care ultrasound (POCUS), is an alternative diagnostic test used to rapidly diagnose a fracture at the time of examination, without exposing children to ionising radiation.","[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Snelling', 'Affiliation': 'School of Medicine and Menzies Health Institute Queensland, Griffith University, Southport, Queensland, Australia. Peter.snelling@health.qld.gov.au.'}, {'ForeName': 'Gerben', 'Initials': 'G', 'LastName': 'Keijzers', 'Affiliation': 'School of Medicine and Menzies Health Institute Queensland, Griffith University, Southport, Queensland, Australia.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Byrnes', 'Affiliation': 'Centre for Applied Health Economics, School of Medicine, Griffith University, Southport, Queensland, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bade', 'Affiliation': ""Department of Orthopaedics, Queensland Children's Hospital, South Brisbane, Queensland, Australia.""}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'George', 'Affiliation': 'School of Medicine and Menzies Health Institute Queensland, Griffith University, Southport, Queensland, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': ""Department of Emergency Medicine, Queensland Children's Hospital, South Brisbane, Queensland, Australia.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Jones', 'Affiliation': 'School of Medicine and Menzies Health Institute Queensland, Griffith University, Southport, Queensland, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Davison', 'Affiliation': 'Department of Emergency Medicine, Sunshine Coast University Hospital, Birtinya, Queensland, Australia.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Roan', 'Affiliation': 'Department of Emergency Medicine, Ipswich Hospital, Ipswich, Queensland, Australia.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Ware', 'Affiliation': 'School of Medicine and Menzies Health Institute Queensland, Griffith University, Southport, Queensland, Australia.'}]",Trials,['10.1186/s13063-021-05239-z'] 3773,33853639,"Efficiency of atorvastatin on in-hospital mortality of patients with acute aortic dissection (AAD): study protocol for a randomized, open-label, superiority clinical trial.","BACKGROUND Dyslipidemia and local inflammation at sites of lipid deposition on blood vessel walls have been demonstrated to be risk factors for patients with acute aortic dissection (AAD). Statins have anti-inflammatory and lipid-lowering effects, which suggest that statins may play an important role in the prevention and treatment of AAD. Some retrospective studies show that statins can protect patients with aortic dissection. However, the effect of statins on the survival of AAD patients has been scarcely investigated, especially in randomized trials. In this study, we will perform a randomized clinical trial to understand whether statins can reduce in-hospital mortality of AAD patients. METHODS A total of 384 subjects diagnosed with AAD in the First Affiliated Hospital of Shantou University Medical College will be recruited. Participants will be randomly divided into an atorvastatin-treated or control group. The primary outcome will be the in-hospital mortality at 30 days. DISCUSSION This study is designed to verify the efficacy of atorvastatin on reducing in-hospital mortality of patients with AAD. The aim is to provide a new means of improving survival as a complement to conventional drug therapy. TRIAL REGISTRATION Chinese Clinical Trials Registry ChiCTR1900023515 . Registered on 1 June 2019.",2021,This study is designed to verify the efficacy of atorvastatin on reducing in-hospital mortality of patients with AAD.,"['384 subjects diagnosed with AAD in the First Affiliated Hospital of Shantou University Medical College', 'patients with acute aortic dissection (AAD', 'AAD patients', 'patients with AAD', 'patients with aortic dissection']","['atorvastatin-treated or control group', 'atorvastatin', 'statins']",['hospital mortality at 30\u2009days'],"[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0340643', 'cui_str': 'Dissection of aorta'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}]","[{'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",384.0,0.173543,This study is designed to verify the efficacy of atorvastatin on reducing in-hospital mortality of patients with AAD.,"[{'ForeName': 'Yequn', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'The First Affiliated Hospital of Shantou University Medical College, Shantou, 515041, Guangdong, China.'}, {'ForeName': 'Nianling', 'Initials': 'N', 'LastName': 'Xiong', 'Affiliation': 'The First Affiliated Hospital of Shantou University Medical College, Shantou, 515041, Guangdong, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The First Affiliated Hospital of Shantou University Medical College, Shantou, 515041, Guangdong, China.'}, {'ForeName': 'Shiwan', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'The First Affiliated Hospital of Shantou University Medical College, Shantou, 515041, Guangdong, China.'}, {'ForeName': 'Liangli', 'Initials': 'L', 'LastName': 'Hong', 'Affiliation': 'The First Affiliated Hospital of Shantou University Medical College, Shantou, 515041, Guangdong, China.'}, {'ForeName': 'Xiru', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'The First Affiliated Hospital of Shantou University Medical College, Shantou, 515041, Guangdong, China.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'The First Affiliated Hospital of Shantou University Medical College, Shantou, 515041, Guangdong, China.'}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'The First Affiliated Hospital of Shantou University Medical College, Shantou, 515041, Guangdong, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'The First Affiliated Hospital of Shantou University Medical College, Shantou, 515041, Guangdong, China.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Ye', 'Affiliation': 'The First Affiliated Hospital of Shantou University Medical College, Shantou, 515041, Guangdong, China. sy127@leicester.au.uk.'}, {'ForeName': 'Xuerui', 'Initials': 'X', 'LastName': 'Tan', 'Affiliation': 'The First Affiliated Hospital of Shantou University Medical College, Shantou, 515041, Guangdong, China. doctortxr@126.com.'}]",Trials,['10.1186/s13063-021-05237-1'] 3774,33853614,"Feasibility and preliminary efficacy of a combined virtual reality, robotics and electrical stimulation intervention in upper extremity stroke rehabilitation.","BACKGROUND Approximately 80% of individuals with chronic stroke present with long lasting upper extremity (UE) impairments. We designed the perSonalized UPper Extremity Rehabilitation (SUPER) intervention, which combines robotics, virtual reality activities, and neuromuscular electrical stimulation (NMES). The objectives of our study were to determine the feasibility and the preliminary efficacy of the SUPER intervention in individuals with moderate/severe stroke. METHODS Stroke participants (n = 28) received a 4-week intervention (3 × per week), tailored to their functional level. The functional integrity of the corticospinal tract was assessed using the Predict Recovery Potential algorithm, involving measurements of motor evoked potentials and manual muscle testing. Those with low potential for hand recovery (shoulder group; n = 18) received a robotic-rehabilitation intervention focusing on elbow and shoulder movements only. Those with a good potential for hand recovery (hand group; n = 10) received EMG-triggered NMES, in addition to robot therapy. The primary outcomes were the Fugl-Meyer UE assessment and the ABILHAND assessment. Secondary outcomes included the Motor Activity Log and the Stroke Impact Scale. RESULTS Eighteen participants (64%), in either the hand or the shoulder group, showed changes in the Fugl-Meyer UE or in the ABILHAND assessment superior to the minimal clinically important difference. CONCLUSIONS This indicates that our personalized approach is feasible and may be beneficial in improving UE function in individuals with moderate to severe impairments due to stroke. TRIAL REGISTRATION ClinicalTrials.gov NCT03903770. Registered 4 April 2019. Registered retrospectively.",2021,"Eighteen participants (64%), in either the hand or the shoulder group, showed changes in the Fugl-Meyer UE or in the ABILHAND assessment superior to the minimal clinically important difference. ","['individuals with moderate to severe impairments due to stroke', 'individuals with moderate/severe stroke', 'individuals with chronic stroke present with long lasting upper extremity (UE) impairments', 'upper extremity stroke rehabilitation', 'Stroke participants (n\u2009=\u200928']","['perSonalized UPper Extremity Rehabilitation (SUPER) intervention, which combines robotics, virtual reality activities, and neuromuscular electrical stimulation (NMES', 'robotic-rehabilitation intervention focusing on elbow and shoulder movements only', 'EMG-triggered NMES', 'SUPER intervention', 'combined virtual reality, robotics and electrical stimulation intervention']","['Motor Activity Log and the Stroke Impact Scale', 'Fugl-Meyer UE', 'Fugl-Meyer UE assessment']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0204097', 'cui_str': 'Stroke rehabilitation'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0427048', 'cui_str': 'Movement of shoulder'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0639392,"Eighteen participants (64%), in either the hand or the shoulder group, showed changes in the Fugl-Meyer UE or in the ABILHAND assessment superior to the minimal clinically important difference. ","[{'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Norouzi-Gheidari', 'Affiliation': 'School of Physical & Occupational Therapy, McGill University, Montreal, Canada.'}, {'ForeName': 'Philippe S', 'Initials': 'PS', 'LastName': 'Archambault', 'Affiliation': 'School of Physical & Occupational Therapy, McGill University, Montreal, Canada. philippe.archambault@mcgill.ca.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Monte-Silva', 'Affiliation': 'Physical Therapy Department, Universidade Federal de Pernambuco, Recife, Brazil.'}, {'ForeName': 'Dahlia', 'Initials': 'D', 'LastName': 'Kairy', 'Affiliation': 'Interdisciplinary Research Center in Rehabilitation, Montreal, Canada.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Sveistrup', 'Affiliation': 'Faculty of Health Sciences, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Trivino', 'Affiliation': 'Interdisciplinary Research Center in Rehabilitation, Montreal, Canada.'}, {'ForeName': 'Mindy F', 'Initials': 'MF', 'LastName': 'Levin', 'Affiliation': 'School of Physical & Occupational Therapy, McGill University, Montreal, Canada.'}, {'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Milot', 'Affiliation': 'School of Rehabilitation, University of Sherbrooke, Sherbrooke, Canada.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-021-00851-1'] 3775,33853609,The use of game modes to promote engagement and social involvement in multi-user serious games: a within-person randomized trial with stroke survivors.,"BACKGROUND Serious games are promising for stroke rehabilitation, with studies showing a positive impact on reducing motor and cognitive deficits. However, most of the evidence is in the context of single-user rehabilitation, and little is known concerning the impact in multi-user settings. This study evaluates the impact that different game modes can have on engagement and social involvement during a two-user game. Specifically, we want to understand the benefits of game modalities based on competition, co-activation, and collaboration and analyze the influence of different motor and cognitive deficits and personality traits. METHODS We developed a two-player setup-using tangible objects and a large screen interactive table-for upper limb rehabilitation purposes. We implemented a game that, while keeping the same basic mechanics, can be played in the three different modes (Competitive, Co-active, and Collaborative). We ran a within-person randomized study with 21 stroke survivors that were paired and played the game in its three versions. We used the Game Experience Questionnaire-Core Module to assess engagement and the Social Presence Module to assess Social Involvement. For personality, motor, and cognitive function, users answered the International Personality Item Pool (short version), Fugl-Meyer Assessment-Upper Extremity, Modified Ashworth Scale, and Montreal Cognitive Assessment, respectively. RESULTS The Collaborative mode promoted significantly more Behavioral Involvement. The Competitive mode promoted more Flow and Challenge than the Co-active mode with participants with better cognitive performance, with low extraversion, or with higher motor skills. Participants with higher cognitive deficits reported more Competence with the Co-active mode. CONCLUSIONS Our results indicate that, for multi-user motor rehabilitation settings, the collaborative mode is the more appropriate gaming approach to promote social involvement, showing a high potential for increasing adherence and effectiveness of therapy. Additionally, we show that a player's motor and cognitive ability and personality should be considered when designing personalized tasks for multiplayer settings.",2021,We developed a two-player setup-using tangible objects and a large screen interactive table-for upper limb rehabilitation purposes.,['21 stroke survivors'],['Game Experience Questionnaire-Core Module to assess engagement and the Social Presence Module'],"['For personality, motor, and cognitive function, users answered the International Personality Item Pool (short version), Fugl-Meyer Assessment-Upper Extremity, Modified Ashworth Scale, and Montreal Cognitive Assessment, respectively', 'Behavioral Involvement']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]",,0.0270474,We developed a two-player setup-using tangible objects and a large screen interactive table-for upper limb rehabilitation purposes.,"[{'ForeName': 'Fábio', 'Initials': 'F', 'LastName': 'Pereira', 'Affiliation': 'Faculdade de Ciências Exatas e da Engenharia, Universidade da Madeira, Campus Universitário da Penteada, 9020-105, Funchal, Portugal. fabiodinis.pereira@m-iti.org.'}, {'ForeName': 'Sergi', 'Initials': 'S', 'LastName': 'Bermúdez I Badia', 'Affiliation': 'Faculdade de Ciências Exatas e da Engenharia, Universidade da Madeira, Campus Universitário da Penteada, 9020-105, Funchal, Portugal.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Jorge', 'Affiliation': 'Madeira Interactive Technologies Institute, Universidade da Madeira, Pólo Científico e Tecnológico da Madeira, Caminho da Penteada, 9020-105, Funchal, Portugal.'}, {'ForeName': 'Mónica S', 'Initials': 'MS', 'LastName': 'Cameirão', 'Affiliation': 'Faculdade de Ciências Exatas e da Engenharia, Universidade da Madeira, Campus Universitário da Penteada, 9020-105, Funchal, Portugal.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-021-00853-z'] 3776,33853608,"Comparison of neuromuscular and cardiovascular exercise intensity and enjoyment between standard of care, off-the-shelf and custom active video games for promotion of physical activity of persons post-stroke.","BACKGROUND Active video games have been embraced for the rehabilitation of mobility and promotion of physical activity for persons post-stroke. This study seeks to compare carefully matched standard of care stepping activities, off-the-shelf (non-custom) active video games and custom active video games that are either self-paced or game-paced for promoting neuromuscular intensity and accuracy, cardiovascular intensity, enjoyment and perceived effort. METHODS Fifteen persons (ages 38-72) with mild to moderate severity in the chronic phase post-stroke (average 8 years) participated in a single group counter balanced repeated measures study. Participants were included if they were greater than 6 months post-stroke, who could walk 100 feet without assistance and stand unsupported for three continuous minutes. They were excluded if they had cardiac, musculoskeletal or neurologic conditions that could interfere with repeated stepping and follow instructions. In a single session located in a laboratory setting, participants executed for 8.5 min each: repeated stepping, the Kinect-light race game, two custom stepping games for the Kinect, one was repeated and self-paced and the other was random and game paced. Custom video games were adjusted to the participants stepping volume. Ten-minute rest periods followed the exercise during which time participants rested and completed the PACES an enjoyment questionnaire. Participants were instrumented with a metabolic cart and heart rate sensor for collection of cardiovascular intensity (METs and % of max HR) data. Stepping frequency, accuracy and pattern were acquired via video. Data were analyzed using a RMANOVA and post-hoc comparison with a Holm's/Sidak correction. RESULTS Neuromuscular intensity (repetitions) was significantly greater for the off-the-shelf and self-paced custom game, however accuracy was greater for the custom games. Cardiovascular intensity for all activities took place in the moderate intensity exercise band. Enjoyment (measured with a questionnaire and rankings) was greater for the custom active video games and rate of perceived exertion was lower for the custom active video games. CONCLUSIONS Custom active video games provided comparable intensity but better accuracy, greater enjoyment and less perceived exertion than standard of care stepping activities and a carefully matched off-the-shelf (non-custom) video game. There were no differences between the game-paced and self-paced custom active video games. TRIAL REGISTRATION NCT04538326.",2021,"Neuromuscular intensity (repetitions) was significantly greater for the off-the-shelf and self-paced custom game, however accuracy was greater for the custom games.","['persons post-stroke', 'Fifteen persons (ages 38-72) with mild to moderate severity in the chronic phase post-stroke (average 8\xa0years', 'Participants were included if they were greater than 6\xa0months post-stroke, who could walk 100 feet without assistance and stand unsupported for three continuous minutes']","['neuromuscular and cardiovascular exercise intensity and enjoyment between standard of care, off-the-shelf and custom active video games']","['Neuromuscular intensity (repetitions', 'neuromuscular intensity and accuracy, cardiovascular intensity, enjoyment and perceived effort', 'Cardiovascular intensity', 'metabolic cart and heart rate sensor for collection of cardiovascular intensity (METs and % of max HR) data', 'Enjoyment']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0179636', 'cui_str': 'Cart'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",,0.0276005,"Neuromuscular intensity (repetitions) was significantly greater for the off-the-shelf and self-paced custom game, however accuracy was greater for the custom games.","[{'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Deutsch', 'Affiliation': 'Rivers Lab, Department of Rehabilitation and Movement Science, Rutgers School of Health Professions, 65 Bergen Street, Newark, NJ, 07101, USA. deutsch@shp.rutgers.edu.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'James-Palmer', 'Affiliation': 'Rivers Lab, Department of Rehabilitation and Movement Science, Rutgers School of Health Professions, 65 Bergen Street, Newark, NJ, 07101, USA.'}, {'ForeName': 'Harish', 'Initials': 'H', 'LastName': 'Damodaran', 'Affiliation': 'Rivers Lab, Department of Rehabilitation and Movement Science, Rutgers School of Health Professions, 65 Bergen Street, Newark, NJ, 07101, USA.'}, {'ForeName': 'Urska', 'Initials': 'U', 'LastName': 'Puh', 'Affiliation': 'Department of Physiotherapy, Faculty of Health Sciences, University of Ljubljana, Ljubljana, Slovenia.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-021-00850-2'] 3777,33853585,"Experimental infection with the hookworm, Necator americanus, is associated with stable gut microbial diversity in human volunteers with relapsing multiple sclerosis.","BACKGROUND Helminth-associated changes in gut microbiota composition have been hypothesised to contribute to the immune-suppressive properties of parasitic worms. Multiple sclerosis is an immune-mediated autoimmune disease of the central nervous system whose pathophysiology has been linked to imbalances in gut microbial communities. RESULTS In the present study, we investigated, for the first time, qualitative and quantitative changes in the faecal bacterial composition of human volunteers with remitting multiple sclerosis (RMS) prior to and following experimental infection with the human hookworm, Necator americanus (N+), and following anthelmintic treatment, and compared the findings with data obtained from a cohort of RMS patients subjected to placebo treatment (PBO). Bacterial 16S rRNA high-throughput sequencing data revealed significantly decreased alpha diversity in the faecal microbiota of PBO compared to N+ subjects over the course of the trial; additionally, we observed significant differences in the abundances of several bacterial taxa with putative immune-modulatory functions between study cohorts. Parabacteroides were significantly expanded in the faecal microbiota of N+ individuals for which no clinical and/or radiological relapses were recorded at the end of the trial. CONCLUSIONS Overall, our data lend support to the hypothesis of a contributory role of parasite-associated alterations in gut microbial composition to the immune-modulatory properties of hookworm parasites.",2021,"Bacterial 16S rRNA high-throughput sequencing data revealed significantly decreased alpha diversity in the faecal microbiota of PBO compared to N+ subjects over the course of the trial; additionally, we observed significant differences in the abundances of several bacterial taxa with putative immune-modulatory functions between study cohorts.","['human volunteers with relapsing multiple sclerosis', 'human volunteers with remitting multiple sclerosis (RMS) prior to and following experimental infection with the human hookworm, Necator americanus (N']",['placebo'],['faecal microbiota of PBO'],"[{'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0002830', 'cui_str': 'Superfamily ancylostomatoidea'}, {'cui': 'C0002826', 'cui_str': 'Necator americanus'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.0769158,"Bacterial 16S rRNA high-throughput sequencing data revealed significantly decreased alpha diversity in the faecal microbiota of PBO compared to N+ subjects over the course of the trial; additionally, we observed significant differences in the abundances of several bacterial taxa with putative immune-modulatory functions between study cohorts.","[{'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Jenkins', 'Affiliation': 'Department of Veterinary Medicine, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Pritchard', 'Affiliation': 'Department of Pharmacy, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Radu', 'Initials': 'R', 'LastName': 'Tanasescu', 'Affiliation': ""Division of Clinical Neurology, School of Clinical Sciences, University of Nottingham, Queen's Medical Centre, Nottingham, UK.""}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Telford', 'Affiliation': 'Department of Pharmacy, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Papaiakovou', 'Affiliation': 'Department of Veterinary Medicine, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Scotti', 'Affiliation': 'Department of Veterinary Medicine, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Cortés', 'Affiliation': 'Department of Veterinary Medicine, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Cris S', 'Initials': 'CS', 'LastName': 'Constantinescu', 'Affiliation': ""Division of Clinical Neurology, School of Clinical Sciences, University of Nottingham, Queen's Medical Centre, Nottingham, UK.""}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Cantacessi', 'Affiliation': 'Department of Veterinary Medicine, University of Cambridge, Cambridge, UK. cc779@cam.ac.uk.'}]",BMC biology,['10.1186/s12915-021-01003-6'] 3778,33853415,Baseline Concussion Testing Increases Agreement With Favorable Concussion Safety Decisions in Hypothetical Scenarios.,"BACKGROUND Dangers of sports-related concussion are well documented, and those participating in sports involving significant contact are at an even higher risk relative to the general population. Despite extensive concussion education, athletes still make decisions that would be considered unsafe, such as underreporting and continuing to play despite experiencing symptoms. Although baseline testing is an increasingly common practice at all levels of sport, little is known about its ability to improve player safety perceptions. AIMS The current study examines whether taking part in a standardized baseline concussion assessment changes athletes' knowledge, attitudes, or perceptions of concussion safety decisions. METHOD A total of 229 club and National Collegiate Athletic Association athletes completed a modified Rosenbaum Concussion Knowledge and Attitudes Survey-Student Version (RoCKAS-ST), which was used to evaluate knowledge, attitudes, and perceptions of concussion safety decisions in hypothetical scenarios. Athletes were randomly assigned to either complete baseline concussion testing prior to the RoCKAS-ST or complete baseline testing after the RoCKAS-ST. RESULTS Athletes randomly assigned to complete baseline testing before the RoCKAS-ST demonstrated greater agreement with favorable concussion safety decisions in hypothetical scenarios relative to athletes completing baseline testing after the RoCKAS-ST. The two conditions did not differ with respect to concussion knowledge or attitudes. DISCUSSION Baseline testing appears to have an added benefit of resulting in more favorable perceptions toward making safe decisions following suspected concussions. CONCLUSION Baseline testing may provide an effective means of improving a broader constellation of concussion safety behavior, particularly in club athletes, who are typically underserved in terms of concussion-related resources and care.",2021,"RESULTS Athletes randomly assigned to complete baseline testing before the RoCKAS-ST demonstrated greater agreement with favorable concussion safety decisions in hypothetical scenarios relative to athletes completing baseline testing after the RoCKAS-ST.",['229 club and National Collegiate Athletic Association athletes completed a'],['modified Rosenbaum Concussion Knowledge and Attitudes Survey-Student Version (RoCKAS-ST'],['concussion knowledge or attitudes'],"[{'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C2607870', 'cui_str': 'Version'}]","[{'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",229.0,0.178914,"RESULTS Athletes randomly assigned to complete baseline testing before the RoCKAS-ST demonstrated greater agreement with favorable concussion safety decisions in hypothetical scenarios relative to athletes completing baseline testing after the RoCKAS-ST.","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Deuschle', 'Affiliation': 'University of North Carolina Wilmington, NC, USA.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Keith', 'Affiliation': 'University of North Carolina Wilmington, NC, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Dugan', 'Affiliation': 'University of North Carolina Wilmington, NC, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'New Hanover Regional Medical Center, Wilmington, NC, USA.'}, {'ForeName': 'Sasi', 'Initials': 'S', 'LastName': 'Taravath', 'Affiliation': 'New Hanover Regional Medical Center, Wilmington, NC, USA.'}, {'ForeName': 'Len', 'Initials': 'L', 'LastName': 'Lecci', 'Affiliation': 'University of North Carolina Wilmington, NC, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/10901981211003509'] 3779,33853413,Three-Dimensional Surface Texture Characterization of In Situ Simulated Erosive Tooth Wear.,"This in situ erosive tooth wear (ETW) study tested enamel 3-dimensional (3D) surface texture outcomes for the detection and differentiation of ETW lesions simulated in clinically relevant conditions. Twenty participants enrolled in this 3-arm crossover intraoral ETW simulation and wore their own partial denture for 14 d holding 2 human enamel specimens (per arm). In each arm, participants were assigned to 1 of 3 different dental erosion protocols: severe (lemon juice/pH 2.5), moderate (grapefruit juice/pH 3.5), and no erosion (bottled drinking water, control). Enamel specimens were evaluated by white-light scanning confocal profilometry for 3D surface texture and surface loss (ETW model validation). Individual point clouds were analyzed using standard dental microwear texture characterization protocols for surface roughness and anisotropy. Fractal complexity ( Asfc ), texture aspect ratio ( Str ), and arithmetical mean height ( Sa ) values were generated at baseline, 7 d, and 14 d. Data were analyzed by analysis of variance models suitable for the crossover design with repeated measurements, and correlation coefficients were used to examine the relationship between outcomes. Asfc and Sa differentiated ETW severity (no erosion < moderate < severe, P < 0.001) at days 7 and 14. Asfc and Sa were lower at baseline compared to days 7 and 14 ( P < 0.001) for moderate and severe challenges. Asfc increased from day 7 to 14 ( P = 0.042) for the severe challenge. For Str , ETW severity did not have a significant effect overall ( P = 0.15). Asfc and Sa were highly positively correlated ( r = 0.89, P < 0.001), while Asfc and Sa were not correlated overall with Str ( r < 0.1, P ≥ 0.25). Enamel surface loss increased with ETW severity (no erosion < moderate < severe, P < 0.001) at days 7 and 14, validating the ETW simulation model. Complexity ( Asfc ) and roughness ( Sa ) outcomes were able to detect and differentiate ETW levels, with Asfc being able to monitor the progression of severe lesions. No clear characterization of ETW lesions could be provided by the anisotropy ( Str ) parameter.",2021,"Enamel surface loss increased with ETW severity (no erosion < moderate < severe, P < 0.001) at days 7 and 14, validating the ETW simulation model.",['Twenty participants enrolled in this 3-arm crossover intraoral ETW simulation and wore their own partial denture for 14 d holding 2 human enamel specimens (per arm'],"['dental erosion protocols: severe (lemon juice/pH 2.5), moderate (grapefruit juice/pH 3.5), and no erosion (bottled drinking water, control']","['Asfc and Sa', 'Fractal complexity ( Asfc ), texture aspect ratio ( Str ), and arithmetical mean height ( Sa ) values', 'Complexity ( Asfc ) and roughness ( Sa ) outcomes', 'ETW severity']","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0442119', 'cui_str': 'Intraoral approach'}, {'cui': 'C0439679', 'cui_str': 'Erosive'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0011460', 'cui_str': 'Partial denture'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0031238', 'cui_str': 'Peru'}]","[{'cui': 'C0040436', 'cui_str': 'Erosion of teeth'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0452457', 'cui_str': 'Lemon Juice'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0452456', 'cui_str': 'GRAPEFRUIT JUICE'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0179376', 'cui_str': 'Bottle'}, {'cui': 'C0599638', 'cui_str': 'Drinking Water'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0206163', 'cui_str': 'Fractals'}, {'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1519302', 'cui_str': 'Short Tandem Repeats'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439679', 'cui_str': 'Erosive'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",20.0,0.0962176,"Enamel surface loss increased with ETW severity (no erosion < moderate < severe, P < 0.001) at days 7 and 14, validating the ETW simulation model.","[{'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Hara', 'Affiliation': 'Indiana University School of Dentistry, Indianapolis, IN, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Elkington-Stauss', 'Affiliation': 'Department of Anthropology, University of Arkansas, Fayetteville, AR, USA.'}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'Ungar', 'Affiliation': 'Department of Anthropology, University of Arkansas, Fayetteville, AR, USA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Lippert', 'Affiliation': 'Indiana University School of Dentistry, Indianapolis, IN, USA.'}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Eckert', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'D T', 'Initials': 'DT', 'LastName': 'Zero', 'Affiliation': 'Indiana University School of Dentistry, Indianapolis, IN, USA.'}]",Journal of dental research,['10.1177/00220345211005678'] 3780,33853109,Electrodermal Activity of Auricular Acupoints in Pediatric Patients with Functional Abdominal Pain Disorders.,"OBJECTIVES Functional abdominal pain disorders (FAPD) affect approximately 13.5% of children. Pharmacotherapy is often ineffective, leaving providers and families seeking adjunctive therapies. Auriculotherapy provides treatment for pain and other symptoms, without a defined protocol for FAPD. A handheld point-finder device measuring transdermal electrical current determines active acupoints, with higher current indicating a more active acupoint. Our objectives were to determine auricular acupoint (AA) activity in FAPD and to assess participants' attitudes towards auriculotherapy. METHODS This is a prospective double-blind study evaluating electrodermal activity of AAs in pediatric-aged female participants with FAPD compared to healthy controls (HC). Participants completed surveys regarding demographics and interest in auriculotherapy. The electrodermal assessment evaluated 20 AAs per ear using a point-finder device. Each AA current measurement was analyzed by average relative rank and median, with a median current measurement ≥50 μA considered active. RESULTS We enrolled 46 female participants, 22 FAPD (mean age 15.8 years) and 24 HC (mean age 15.4 years). In FAPD, 12/40 AAs were active, of which only 6 were also active in HC. Comparison of median current and average ranking between participants demonstrated consistency. In the post-assessment survey, 86.4% of FAPD expressed interest in receiving auricular acupressure and 68.2% would travel to clinic solely for treatment. CONCLUSIONS Based on electrodermal measurements, we propose a treatment protocol using auriculotherapy for FAPD symptom-management. We demonstrated there is considerable patient interest in auriculotherapy. Further studies are needed to confirm the findings in a larger sample size and validate the efficacy of this treatment protocol. ABSTRACT An infographic is available for this article at:http://links.lww.com/MPG/C322.",2021,"In the post-assessment survey, 86.4% of FAPD expressed interest in receiving auricular acupressure and 68.2% would travel to clinic solely for treatment. ","['pediatric-aged female participants with FAPD compared to healthy controls (HC', '46 female participants, 22 FAPD (mean age 15.8\u200ayears) and 24 HC (mean age 15.4\u200ayears', 'Pediatric Patients with Functional Abdominal Pain Disorders']","['Auriculotherapy', 'auriculotherapy', 'Auricular Acupoints', 'Pharmacotherapy']",['auricular acupoint (AA) activity'],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1609533', 'cui_str': 'Functional abdominal pain'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191316', 'cui_str': '15.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517579', 'cui_str': '15.4'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C2350276', 'cui_str': 'Auriculotherapy'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",46.0,0.213999,"In the post-assessment survey, 86.4% of FAPD expressed interest in receiving auricular acupressure and 68.2% would travel to clinic solely for treatment. ","[{'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Borlack', 'Affiliation': 'Jacobs School of Medicine and Biomedical Sciences, The State University of New York at Buffalo, Buffalo NY Division of Pediatric Gastroenterology and Nutrition, UBMD Pediatrics Columbia University, New York, New York Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Columbia University Vagelos College of Physicians and Surgeons, New York, New York Heilbrunn Department of Population & Family Health, Columbia University Mailman School of Public Health, New York, New York Department of Pediatrics, Columbia University Irving Medical Center and Heilbrunn Department of Population & Family Health, Columbia University Mailman School of Public Health, New York, New York.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Shan', 'Affiliation': ''}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Zong', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Khlevner', 'Affiliation': ''}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Garbers', 'Affiliation': ''}, {'ForeName': 'Melanie A', 'Initials': 'MA', 'LastName': 'Gold', 'Affiliation': ''}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000003137'] 3781,33853099,"Effect of Music on Fatigue, Comfort, and Vital Signs in Patients After Liver Transplant Surgery: A Randomized Controlled Trial.","This randomized controlled clinical trial was conducted to determine the effect of music therapy on fatigue, comfort and vital signs of the liver transplant patients. The study sample comprised 120 adult patients (60 in the experimental and 60 in the control group) who met the inclusion criteria and agreed to participate in the study. In the experimental group, the researcher performed music therapy. After applying music therapy once to patients for 30 minutes, their fatigue, comfort, and vital signs were evaluated. No treatment was performed in the control group. According to music therapy follow-ups after liver transplantation, mean scores of fatigue levels were lower, comfort levels were higher, and vital signs were normal, with a statistical significance in the experimental group compared with the control group in all measurements before and after music therapy (P < .001). The study should be repeated using different parameters.",2021,"According to music therapy follow-ups after liver transplantation, mean scores of fatigue levels were lower, comfort levels were higher, and vital signs were normal, with a statistical significance in the experimental group compared with the control group in all measurements before and after music therapy (P < .001).","['Patients', '120 adult patients (60 in the experimental and 60 in the control group) who met the inclusion criteria and agreed to participate in the study', 'After Liver Transplant Surgery', 'liver transplant patients']","['Music', 'music therapy']","['fatigue, comfort and vital signs', 'mean scores of fatigue levels', 'Fatigue, Comfort, and Vital Signs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2586108', 'cui_str': 'Level of fatigue'}]",120.0,0.05806,"According to music therapy follow-ups after liver transplantation, mean scores of fatigue levels were lower, comfort levels were higher, and vital signs were normal, with a statistical significance in the experimental group compared with the control group in all measurements before and after music therapy (P < .001).","[{'ForeName': 'Bilsev', 'Initials': 'B', 'LastName': 'Demir', 'Affiliation': 'Surgical Nursing, Vocational High School of Health Care, Selcuk University, Konya, Turkey (Dr Demir); Surgical Diseases Nursing, Institute of Health Sciences, Inonu University, Malatya, Turkey (Dr Kapιkιran); and Department of Surgical Nursing, Faculty of Nursing, Inonu University, Malatya, Turkey (Dr Özkan). Dr Demir is now with the Department of Surgical Nursing, Malatya Turgut Özal University, Malatya, Turkey and Dr Kapιkιran is now with the Department of Surgical Nursing, Bingöl University, Bingöl, Turkey.'}, {'ForeName': 'Gürkan', 'Initials': 'G', 'LastName': 'Kapιkιran', 'Affiliation': ''}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Özkan', 'Affiliation': ''}]",Holistic nursing practice,['10.1097/HNP.0000000000000444'] 3782,33853098,Effect of Foot Massages on Postpartum Comfort and Pain Level of Mothers After Vaginal Delivery: A Randomized Trial.,"This study conducted on 66 mothers aimed to investigate the effect of foot massages postpartum using an introductory information form, the Postpartum Comfort Scale, the visual analog scale, and a drug follow-up card. It was concluded that foot massages positively improved comfort, reduced pain levels, and reduced unnecessary medications.",2021,"It was concluded that foot massages positively improved comfort, reduced pain levels, and reduced unnecessary medications.","['Mothers After Vaginal Delivery', '66 mothers']",['Foot Massages'],"['Postpartum Comfort and Pain Level', 'comfort, reduced pain levels, and reduced unnecessary medications']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",66.0,0.0307514,"It was concluded that foot massages positively improved comfort, reduced pain levels, and reduced unnecessary medications.","[{'ForeName': 'Sibel', 'Initials': 'S', 'LastName': 'Icke', 'Affiliation': 'Department of Midwifery, Faculty of Health Sciences, Mardin Artuklu University, Mardin, Turkey (Dr Icke); and Department of Midwifery, Faculty of Health Sciences, Ege University, Izmir, Turkey (Dr Genc).'}, {'ForeName': 'Rabia', 'Initials': 'R', 'LastName': 'Genc', 'Affiliation': ''}]",Holistic nursing practice,['10.1097/HNP.0000000000000441'] 3783,33853071,Effects of Mental Imagery on Prospective Memory: A Process Analysis in Individuals with Amnestic Mild Cognitive Impairment.,"INTRODUCTION Prospective memory (PM) is a multiphasic cognitive function important for autonomy and functional independence but is easily disrupted by pathological aging processes. Through cognitive simulation of perceptual experiences, mental imagery could be an effective compensatory strategy to enhance PM performance. Nevertheless, relevant research in individuals with amnestic mild cognitive impairment (MCI) has been limited, and the underlying mechanism of the therapeutic effect has not been sufficiently elucidated. The present study aimed to examine complex PM performances and the effect of mental imagery on each phase in older adults with MCI and to investigate the underlying cognitive mechanism from a process perspective. METHODS Twenty-eight MCI and 32 normal aging controls completed a seminaturalistic PM task, in addition to a series of neuropsychological tests. Participants from each group were randomly assigned to a mental imagery condition or a standard repeated encoding condition before performing the PM task. Four indices were used to measure performance in the intention formation, intention retention, intention initiation, and intention execution phases of PM. Performances in each phase was compared between the 2 diagnostic groups and the 2 instruction conditions. RESULTS The MCI group performed worse than the normal aging group in the intention formation and intention retention phases. The participants in the mental imagery condition performed significantly better than those in the standard condition during the intention formation, intention retention, and intention execution phases, regardless of the diagnostic group. Moreover, there was a significant interaction between the group and condition during intention retention, showing that people with MCI benefited even more from mental imagery than normal aging in this phase. Performance in the intention retention phase predicted performance in the intention initiation and intention execution phases. DISCUSSION PM deficits in MCI mainly manifest during planning and retaining intentions. Mental imagery was able to promote performance in all but the initiation phase, although a trend for improvement was observed in this phase. The effects of mental imagery may be exerted in the intention retention phase by strengthening the PM cue-action bond, thereby facilitating the probability of intention initiation and bolstering fidelity to the original plan during intention execution.",2021,"The participants in the mental imagery condition performed significantly better than those in the standard condition during the intention formation, intention retention, and intention execution phases, regardless of the diagnostic group.","['individuals with amnestic mild cognitive impairment (MCI', 'Prospective Memory', 'older adults with MCI', 'Individuals with Amnestic Mild Cognitive Impairment', 'Twenty-eight MCI and 32 normal aging controls completed a seminaturalistic PM task, in addition to a series of neuropsychological tests']","['mental imagery', 'mental imagery condition or a standard repeated encoding condition before performing the PM task', 'Mental Imagery', 'MCI']","['intention formation, intention retention, intention initiation, and intention execution phases of PM', 'intention formation, intention retention, and intention execution phases']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0589154', 'cui_str': 'Prospective memory'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0589154', 'cui_str': 'Prospective memory'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C1278561', 'cui_str': 'Judicial execution'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0589154', 'cui_str': 'Prospective memory'}]",4.0,0.0124031,"The participants in the mental imagery condition performed significantly better than those in the standard condition during the intention formation, intention retention, and intention execution phases, regardless of the diagnostic group.","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Cheng', 'Affiliation': 'Department of Psychiatry, Hsinchu MacKay Memorial Hospital, MacKay Medical Foundation, The Presbyterian Church in Taiwan, Hsinchu, Taiwan.'}, {'ForeName': 'Min-Chien', 'Initials': 'MC', 'LastName': 'Tu', 'Affiliation': 'Department of Neurology, Taichung Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Taichung, Taiwan.'}, {'ForeName': 'Wen-Hui', 'Initials': 'WH', 'LastName': 'Huang', 'Affiliation': 'Department of Neurology, Taichung Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Taichung, Taiwan.'}, {'ForeName': 'Yen-Hsuan', 'Initials': 'YH', 'LastName': 'Hsu', 'Affiliation': 'Department of Psychology, National Chung Cheng University, Chiayi, Taiwan.'}]",Gerontology,['10.1159/000514869'] 3784,33853021,Identifying treatment moderators of a trauma-informed parenting intervention with children in foster care: Using model-based recursive partitioning.,"BACKGROUND Trauma-informed parenting interventions have been used in child welfare to help caregivers respond to children in trauma-informed ways that can mitigate the effects of maltreatment and build strong caregiver-child relationships. Existing studies support their effectiveness with children and youth involved in the child welfare system. However, to further advance the effectiveness of evidenced-based intervention for child welfare populations, one key step is to identify subgroups of individuals who have different intervention responses or outcomes. OBJECTIVE To identify pre-treatment moderators that can distinguish subgroups of caregivers and children who benefit differently from an intervention. PARTICIPANTS AND SETTING 414 children in foster care (age 3 or younger) and their caregivers (birth, adoptive, kin, and nonkin) were randomly assigned to receive a trauma-informed parenting intervention in the Illinois Birth through Three Title IV-E waiver demonstration or foster care services as usual. METHODS Model-based Recursive Partitioning (MOB) was used to identify treatment moderators and moderator interactions. MOB fits a parametric model and uses a data-driven method to find subgroups for which the specified parametric model has different parameters. Two parametric models (logistic and linear regression) were used in accordance with two outcomes: reunification (binary) and caregiver-child attachment (continuous). We examined 21 potential pre-treatment moderators in both models. RESULTS For the reunification outcome, the MOB produced the following three treatment moderators, which identified subgroups of participants who responded differently to the intervention: (a) caregivers' relationship with the child (kin vs. non-kin/permanent caregivers), (b) caregiver-child attachment, and (c) case history of physical abuse. For the attachment outcome, caregivers' age was found to be a treatment moderator. Future developments of trauma-informed interventions should consider these moderators.",2021,"For the reunification outcome, the MOB produced the following three treatment moderators, which identified subgroups of participants who responded differently to the intervention: (a) caregivers' relationship with the child (kin vs. non-kin/permanent caregivers), (b) caregiver-child attachment, and (c) case history of physical abuse.","['caregivers and children who benefit differently from an intervention', '414 children in foster care (age 3 or younger) and their caregivers (birth, adoptive, kin, and nonkin']","['trauma-informed parenting intervention', 'trauma-informed parenting intervention in the Illinois Birth through Three Title IV-E waiver demonstration or foster care services as usual']",[],"[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517771', 'cui_str': '414'}, {'cui': 'C0580719', 'cui_str': 'Child in foster care'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0682416', 'cui_str': 'Ruanda language'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0020898', 'cui_str': 'Illinois'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0419195', 'cui_str': 'Foster care'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",[],414.0,0.0411425,"For the reunification outcome, the MOB produced the following three treatment moderators, which identified subgroups of participants who responded differently to the intervention: (a) caregivers' relationship with the child (kin vs. non-kin/permanent caregivers), (b) caregiver-child attachment, and (c) case history of physical abuse.","[{'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Chung', 'Affiliation': 'School of Social Work, University of North Carolina at Chapel Hill, USA. Electronic address: gcsk1982@live.unc.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ansong', 'Affiliation': 'School of Social Work, University of North Carolina at Chapel Hill, USA.'}, {'ForeName': 'Kanisha C', 'Initials': 'KC', 'LastName': 'Brevard', 'Affiliation': 'School of Social Work, University of North Carolina at Chapel Hill, USA.'}, {'ForeName': 'Ding-Geng', 'Initials': 'DG', 'LastName': 'Chen', 'Affiliation': 'School of Social Work, University of North Carolina at Chapel Hill, USA.'}]",Child abuse & neglect,['10.1016/j.chiabu.2021.105065'] 3785,33853014,Psychological training to improve psychosocial function in patients with major depressive disorder: A randomised clinical trial.,"Cognitive and emotional remediation training for depression (CERT-D): a randomised controlled trial to improve cognitive, emotional and functional outcomes in depression The aim of the current study was to evaluate an experimental treatment designed to improve psychosocial function in patients with Major Depressive Disorder (MDD) by reinforcing cognitive, emotional, and social-cognitive abilities. Participants (N = 112) with current or lifetime MDD were recruited to participate in a randomised, blinded, controlled trial. Exclusion criteria included diagnosis of a substance abuse disorder, bipolar disorder organic, eating disorders, or illness which affect cognitive function. The treatment involved repeated cognitive training designed to improve cognitive, emotional, and social-cognitive abilities. In training sessions, the principles of cognitive training were applied across cognitive, emotional, and social domains, with participants completing repeated mental exercises. Exercises included critically analysing interpretations of social interactions (e.g., body language), exploring emotional reactions to stimuli, and completing game-like cognitive training tasks. Training sessions placed great emphasis on the application of trained cognitive, emotional, and social cognitive skills to psychosocial outcomes. Outcomes demonstrated significant improvement in psychosocial function, symptom severity, self-reported cognition, and social-cognition. Our findings demonstrate the efficacy of multi-domain cognitive training to improve psychosocial functioning in individuals with MDD. We suggest that the present treatment could be deployed at a lower cost and with minimal training in comparison to established psychological therapies.",2021,"Cognitive and emotional remediation training for depression (CERT-D): a randomised controlled trial to improve cognitive, emotional and functional outcomes in depression The aim of the current study was to evaluate an experimental treatment designed to improve psychosocial function in patients with Major Depressive Disorder (MDD) by reinforcing cognitive, emotional, and social-cognitive abilities.","['patients with major depressive disorder', 'individuals with MDD', 'patients with Major Depressive Disorder (MDD) by reinforcing cognitive, emotional, and social-cognitive abilities', 'Participants (N\xa0=\xa0112) with current or lifetime MDD', 'depression (CERT-D']","['multi-domain cognitive training', 'Cognitive and emotional remediation training', 'Psychological training']","['psychosocial function, symptom severity, self-reported cognition, and social-cognition', 'psychosocial functioning', 'psychosocial function', 'cognitive, emotional, and social-cognitive abilities', 'interpretations of social interactions (e.g., body language), exploring emotional reactions to stimuli, and completing game-like cognitive training tasks']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C0005892', 'cui_str': 'Body Language'}, {'cui': 'C0221736', 'cui_str': 'Reaction emotional'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]",112.0,0.0396388,"Cognitive and emotional remediation training for depression (CERT-D): a randomised controlled trial to improve cognitive, emotional and functional outcomes in depression The aim of the current study was to evaluate an experimental treatment designed to improve psychosocial function in patients with Major Depressive Disorder (MDD) by reinforcing cognitive, emotional, and social-cognitive abilities.","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Knight', 'Affiliation': 'Discipline of Psychiatry, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Lyrtzis', 'Affiliation': 'Discipline of Psychiatry, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Célia', 'Initials': 'C', 'LastName': 'Fourrier', 'Affiliation': 'Discipline of Psychiatry, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Aboustate', 'Affiliation': 'Discipline of Psychiatry, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Sampson', 'Affiliation': 'Discipline of Psychiatry, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Hikaru', 'Initials': 'H', 'LastName': 'Hori', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Occupational and Environmental Health, Kitakyushu City, Japan.'}, {'ForeName': 'Micah', 'Initials': 'M', 'LastName': 'Cearns', 'Affiliation': 'Discipline of Psychiatry, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Morgan', 'Affiliation': 'Discipline of Psychiatry, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Toben', 'Affiliation': 'Discipline of Psychiatry, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Bernhard T', 'Initials': 'BT', 'LastName': 'Baune', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Münster, University of Münster, Münster, Germany; Department of Psychiatry, Melbourne Medical School, The University of Melbourne, Melbourne, Australia; The Florey Institute of Neuroscience and Mental Health, The Universit y of Melbourne, Parkville, VIC, Australia. Electronic address: Bernhard.Baune@ukmuenster.de.'}]",Psychiatry research,['10.1016/j.psychres.2021.113906'] 3786,33852958,Alternating fast and slow chest compression rates during CPR improved hemodynamics.,"INTRODUCTION Mechanical chest compression devices allow for variation in chest compression (CCs) characteristics from moment to moment, enabling therapy that is not feasible for manual CCs. Effects of varying compressions over time have not been studied. In a randomized trial in an experimental model of prolonged cardiac arrest, we compared time-varying CPR (TVCPR), alternating between 100 and 200 compressions per minute (cpm) every 6seconds, to guidelines CPR (Control). METHODS Ventricular fibrillation (VF) was electrically induced in 20 anesthetized pigs (28.4-45.8kg). Following 10minutes of untreated VF, cardiopulmonary resuscitation (CPR) began, randomized to TVCPR or Control. Rate of return of spontaneous circulation (ROSC), 4-hour survival, and hemodynamics during the first 5minutes of CPR were compared between groups. Moment-to-moment hemodynamic effects of changing the CC rate were analyzed. RESULTS TVCPR improved the proportion of ROSC over time compared to Control (p<0.05) but ROSC (9/10 vs. 5/10) and 4-hour survival (8/10 vs 5/10) did not differ significantly between groups. During CPR, coronary and cerebral perfusion pressures and femoral artery pressure did not differ between groups; however, end-tidal CO 2 and mixed venous O 2 saturation were higher, and pulmonary artery pressure was lower (p<0.05) for TVCPR than Control. During TVCPR, switching to 100 cpm increased coronary perfusion pressure (p<0.05), and switching to 200 cpm increased cerebral perfusion pressure (p<0.05). CONCLUSIONS Time-varying CPR significantly improved indicators of net forward blood flow and proportion of ROSC over time without negatively impacting perfusion pressures. Alternating CC rate alternates between perfusion pressures favoring the brain and those favoring the heart. Time-varying CPR represents a new avenue of research for optimizing CPR. INSTITUTIONAL PROTOCOL NUMBER University of Alabama at Birmingham Institutional Animal Care and Use Committee (IACUC) Protocol Number 140406860.",2021,"RESULTS TVCPR improved the proportion of ROSC over time compared to Control (p<0.05) but ROSC (9/10 vs. 5/10) and 4-hour survival (8/10 vs 5/10) did not differ significantly between groups.",['20 anesthetized pigs (28.4-45.8kg'],"['TVCPR or Control', 'time-varying CPR (TVCPR']","['cerebral perfusion pressure', 'pulmonary artery pressure', '4-hour survival', 'Rate of return of spontaneous circulation (ROSC), 4-hour survival, and hemodynamics during the first 5minutes of CPR', 'coronary perfusion pressure', 'CPR, coronary and cerebral perfusion pressures and femoral artery pressure', 'proportion of ROSC over time']","[{'cui': 'C0039005', 'cui_str': 'Suidae'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0428713', 'cui_str': 'Cerebral perfusion pressure'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C1292426', 'cui_str': '4 hours'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0458194,"RESULTS TVCPR improved the proportion of ROSC over time compared to Control (p<0.05) but ROSC (9/10 vs. 5/10) and 4-hour survival (8/10 vs 5/10) did not differ significantly between groups.","[{'ForeName': 'Tyson G', 'Initials': 'TG', 'LastName': 'Taylor', 'Affiliation': 'Stryker Emergency Care, Redmond, WA, United States. Electronic address: tyson.taylor@stryker.com.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Esibov', 'Affiliation': 'Stryker Emergency Care, Redmond, WA, United States.'}, {'ForeName': 'Sharon B', 'Initials': 'SB', 'LastName': 'Melnick', 'Affiliation': 'Cardiac Rhythm Management Lab, University of Alabama at Birmingham, Birmingham AL, United States.'}, {'ForeName': 'Fred W', 'Initials': 'FW', 'LastName': 'Chapman', 'Affiliation': 'Stryker Emergency Care, Redmond, WA, United States.'}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Walcott', 'Affiliation': 'Cardiac Rhythm Management Lab, University of Alabama at Birmingham, Birmingham AL, United States.'}]",Resuscitation,['10.1016/j.resuscitation.2021.03.035'] 3787,33852940,Neuroplastic effects of a selective serotonin reuptake inhibitor in relearning and retrieval.,"Animal studies using selective serotonin reuptake inhibitors (SSRIs) and learning paradigms demonstrated that serotonin is important for flexibility in executive functions and learning. SSRIs might facilitate relearning through neuroplastic processes and thus exert their clinical effects in psychiatric diseases where cognitive functioning is affected. However, translation of these mechanisms to humans is missing. In this randomized placebo-controlled trial, we assessed functional brain activation during learning and memory retrieval in healthy volunteers performing associative learning tasks aiming to translate facilitated relearning by SSRIs. To this extent, seventy-six participants underwent three MRI scanning sessions: (1) at baseline, (2) after three weeks of daily associative learning and subsequent retrieval (face-matching or Chinese character-noun matching) and (3) after three weeks of relearning under escitalopram (10mg/day) or placebo. Associative learning and retrieval tasks were performed during each fMRI session. Statistical modelling was done using a repeated-measures ANOVA, to test for content-by-treatment-by-time interaction effects. During the learning task, a significant substance-by-time interaction was found in the right insula showing a greater deactivation in the SSRI cohort after 21 days of relearning compared to the learning phase. In the retrieval task, there was a significant content-by-time interaction in the left angular gyrus (AG) with an increased activation in face-matching compared to Chinese-character matching for both learning and relearning phases. A further substance-by-time interaction was found in task performance after 21 days of relearning, indicating a greater decrease of performance in the placebo group. Our findings that escitalopram modulate insula activation demonstrates successful translation of relearning as a mechanism of SSRIs in human. Furthermore, we show that the left AG is an active component of correct memory retrieval, which coincides with previous literature. We extend the function of this region by demonstrating its activation is not only stimulus dependent but also time constrained. Finally, we were able to show that escitalopram aids in relearning, irrespective of content.",2021,"In the retrieval task, there was a significant content-by-time interaction in the left angular gyrus (AG) with an increased activation in face-matching compared to Chinese-character matching for both learning and relearning phases.",['healthy volunteers performing associative learning tasks aiming to translate facilitated relearning by SSRIs'],"['daily associative learning and subsequent retrieval (face-matching or Chinese character-noun matching) and (3) after three weeks of relearning under escitalopram (10mg/day) or placebo', 'selective serotonin reuptake inhibitor', 'selective serotonin reuptake inhibitors (SSRIs', 'placebo']","['task performance', 'Associative learning and retrieval tasks', 'functional brain activation']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0009649', 'cui_str': 'Conditioning, Classical'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0040710', 'cui_str': 'Translating'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009649', 'cui_str': 'Conditioning, Classical'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0007952', 'cui_str': 'Character'}, {'cui': 'C4082109', 'cui_str': 'Three weeks'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}]","[{'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0009649', 'cui_str': 'Conditioning, Classical'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}]",76.0,0.126632,"In the retrieval task, there was a significant content-by-time interaction in the left angular gyrus (AG) with an increased activation in face-matching compared to Chinese-character matching for both learning and relearning phases.","[{'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Reed', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Vanicek', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Seiger', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Klöbl', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Spurny', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Handschuh', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Ritter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Unterholzner', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'G M', 'Initials': 'GM', 'LastName': 'Godbersen', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Gryglewski', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kraus', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Winkler', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hahn', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Lanzenberger', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria. Electronic address: rupert.lanzenberger@meduniwien.ac.at.'}]",NeuroImage,['10.1016/j.neuroimage.2021.118039'] 3788,33852934,Self-Adjustment of Deep Brain Stimulation Delays Optimization in Parkinson's disease.,"BACKGROUND Parkinson's Disease patients undergo time-consuming programming to refine stimulation parameters after deep brain stimulation surgery. OBJECTIVE To assess whether the use of the advanced functions of a patient's programmer would facilitate programming of deep brain stimulation. METHODS Thirty patients were randomly allocated to the use of advanced versus simple mode of the patient programmer in this single-centre, prospective, randomized, controlled study. Primary outcome was the number of days required to optimize the stimulation settings. RESULTS The number of days required to optimize stimulation was significantly lower in the simple mode (88.5±33.1 vs. 142.1±67.4, p=0.01). In addition, the advanced mode group had a higher number of side effects (5.4±3.1 vs. 2.6±1.9, p=0.0055). CONCLUSIONS The use of the advanced functions of patient programmer delays programming optimization and it is associated with a higher number of side effects. These findings highlight the need for other methods for faster and safer stimulation programming.",2021,The use of the advanced functions of patient programmer delays programming optimization and it is associated with a higher number of side effects.,"[""Parkinson's disease"", 'Thirty patients']",['Self-Adjustment of Deep Brain Stimulation Delays Optimization'],"['number of days required to optimize the stimulation settings', 'side effects', 'number of days required to optimize stimulation']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",30.0,0.0631845,The use of the advanced functions of patient programmer delays programming optimization and it is associated with a higher number of side effects.,"[{'ForeName': 'Lais M', 'Initials': 'LM', 'LastName': 'Oliveira', 'Affiliation': ""Edmond J. Safra Program in Parkinson's Disease and Morton and Gloria Shulman Movement Disorders Clinic, Toronto Western Hospital, UHN, Division of Neurology, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Marta Ruiz', 'Initials': 'MR', 'LastName': 'Lopez', 'Affiliation': ""Edmond J. Safra Program in Parkinson's Disease and Morton and Gloria Shulman Movement Disorders Clinic, Toronto Western Hospital, UHN, Division of Neurology, University of Toronto, Toronto, Ontario, Canada; Neurology Department, Cruces University Hospital, Barakaldo, Bizkaia, Spain.""}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Boutet', 'Affiliation': 'Division of Neurosurgery, University Health Network, University of Toronto, Toronto, Ontario, Canada; Joint Department of Medical Imaging, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Gavin J B', 'Initials': 'GJB', 'LastName': 'Elias', 'Affiliation': 'Division of Neurosurgery, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Suneil K', 'Initials': 'SK', 'LastName': 'Kalia', 'Affiliation': 'Division of Neurosurgery, University Health Network, University of Toronto, Toronto, Ontario, Canada; Krembil Brain Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Hodaie', 'Affiliation': 'Division of Neurosurgery, University Health Network, University of Toronto, Toronto, Ontario, Canada; Krembil Brain Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Andres M', 'Initials': 'AM', 'LastName': 'Lozano', 'Affiliation': 'Division of Neurosurgery, University Health Network, University of Toronto, Toronto, Ontario, Canada; Krembil Brain Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Renato P', 'Initials': 'RP', 'LastName': 'Munhoz', 'Affiliation': ""Edmond J. Safra Program in Parkinson's Disease and Morton and Gloria Shulman Movement Disorders Clinic, Toronto Western Hospital, UHN, Division of Neurology, University of Toronto, Toronto, Ontario, Canada; Krembil Brain Institute, Toronto, Ontario, Canada.""}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Fasano', 'Affiliation': ""Edmond J. Safra Program in Parkinson's Disease and Morton and Gloria Shulman Movement Disorders Clinic, Toronto Western Hospital, UHN, Division of Neurology, University of Toronto, Toronto, Ontario, Canada; Krembil Brain Institute, Toronto, Ontario, Canada; CenteR for Advancing Neurotechnological Innovation to Application (CRANIA), Toronto, ON, Canada. Electronic address: alfonso.fasano@uhn.ca.""}]",Brain stimulation,['10.1016/j.brs.2021.04.001'] 3789,33852919,A randomized trial of Mycobacterium w in severe presumed Gram-negative sepsis (MIST).,"BACKGROUND Mycobacterium w (Mw), an immunomodulator, has been shown to resolve early organ failure in severe sepsis. RESEARCH QUESTION Does Mw improve survival in subjects with severe presumed Gram-negative sepsis? STUDY DESIGN and methods: This was a randomized, double-blind, placebo-controlled, parallel-group study conducted in intensive care units (ICUs) of five tertiary care centers in India. We included consecutive subjects (aged ≥18 years) with presumed Gram-negative sepsis in the study within 48 hours of the first organ dysfunction. Subjects in the treatment arm received 0.3 mL/day of Mw intradermally for three consecutive days, while the control arm received matching placebo. The primary outcome was 28-day all-cause mortality. The secondary outcomes were ventilator-free days, days on vasopressor therapy, ICU-and hospital length of stay, nosocomial infection rate, antibiotic use duration, and delta SOFA. RESULTS We included 202 subjects with severe sepsis (101 Mw, 101 placebo). The use of Mw significantly reduced the mortality (9/101 vs. 20/101, estimate difference [95% confidence interval], 0.11 [0.01 to 0.21], p value=0.04). We found no difference in ventilator-free days, days on vasopressor drugs, ICU, and the hospital length of stay. The time to mortality (median 13 vs. 8.5 days) was significantly longer in the Mw than in the placebo arm. The delta SOFA score, the rate of nosocomial infections, and the antibiotic use duration were similar in the two arms. We found Mw to significantly reduce the odds (odds ratio [95% confidence interval], 0.37 [0.15-0.9]) of mortality after adjusting for culture-positive sepsis, the baseline SOFA score, age, and sex. INTERPRETATION The use of Mw was associated with a significant reduction in mortality in patients with severe presumed Gram-negative sepsis. Further studies are required to confirm our findings.",2021,"The delta SOFA score, the rate of nosocomial infections, and the antibiotic use duration were similar in the two arms.","['202 subjects with severe sepsis (101 Mw, 101 placebo', 'severe presumed Gram-negative sepsis (MIST', 'subjects with severe presumed Gram-negative sepsis', 'and methods', 'patients with severe presumed Gram-negative sepsis', 'consecutive subjects (aged ≥18 years) with presumed Gram-negative sepsis in the study within 48 hours of the first organ dysfunction', 'intensive care units (ICUs) of five tertiary care centers in India']",['placebo'],"['mortality', 'delta SOFA score, the rate of nosocomial infections, and the antibiotic use duration', '28-day all-cause mortality', 'time to mortality', 'ventilator-free days, days on vasopressor therapy, ICU-and hospital length of stay, nosocomial infection rate, antibiotic use duration, and delta SOFA', 'ventilator-free days, days on vasopressor drugs, ICU, and the hospital length of stay']","[{'cui': 'C1719672', 'cui_str': 'Severe Sepsis'}, {'cui': 'C0026912', 'cui_str': 'Mycobacterium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0036685', 'cui_str': 'Gram negative sepsis'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0010356', 'cui_str': 'Cross infection'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",202.0,0.361632,"The delta SOFA score, the rate of nosocomial infections, and the antibiotic use duration were similar in the two arms.","[{'ForeName': 'Inderpaul Singh', 'Initials': 'IS', 'LastName': 'Sehgal', 'Affiliation': 'Assistant Professor, Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Nita M', 'Initials': 'NM', 'LastName': 'Basumatary', 'Affiliation': 'Senior Resident, Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Sahajal', 'Initials': 'S', 'LastName': 'Dhooria', 'Affiliation': 'Assistant Professor, Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Kuruswamy Thurai', 'Initials': 'KT', 'LastName': 'Prasad', 'Affiliation': 'Assistant Professor, Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Valliappan', 'Initials': 'V', 'LastName': 'Muthu', 'Affiliation': 'Assistant Professor, Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Ashutosh N', 'Initials': 'AN', 'LastName': 'Aggarwal', 'Affiliation': 'Professor & Head, Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Arnab', 'Initials': 'A', 'LastName': 'Pal', 'Affiliation': 'Additional Professor, Department of Biochemistry, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Maharshi', 'Initials': 'M', 'LastName': 'Desai', 'Affiliation': 'Consultant, Apollo Hospital, Gandhinagar.'}, {'ForeName': 'Dhruva', 'Initials': 'D', 'LastName': 'Chaudhry', 'Affiliation': 'Senior Professor, PGIMS, Rohtak.'}, {'ForeName': 'Pravin Dinkar', 'Initials': 'PD', 'LastName': 'Supe', 'Affiliation': 'Consultant, Supe Heart and diabetic hospital and research center, Nasik.'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Kurmi', 'Affiliation': 'Consultant, Shivam Hospital, Ahmedabad.'}, {'ForeName': 'Rajat', 'Initials': 'R', 'LastName': 'Choudhuri', 'Affiliation': 'Associate Professor, SSKM PGI, Kolkata.'}, {'ForeName': 'Chaitri', 'Initials': 'C', 'LastName': 'Shah', 'Affiliation': 'Consultant, SBKS MI RC, Vadodara.'}, {'ForeName': 'Ritesh', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Professor, Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India. Electronic address: agarwal.ritesh@otlook.in.'}]",Chest,['10.1016/j.chest.2021.03.062'] 3790,33852887,Metabolic Syndrome in Obesity: Treatment Success and Adverse Pregnancy Outcomes with Ovulation Induction in Polycystic Ovary Syndrome.,"OBJECTIVE Obesity is common in women with polycystic ovary syndrome (PCOS). PCOS and obesity are associated with reduced fertility. Metabolic syndrome's (MetS) effect on infertility treatment success and pregnancy outcomes in women with PCOS undergoing ovulation induction (OI) has not been investigated. The objectives of this study were to determine the associations of MetS with OI live birth rate and pregnancy complications in obese women with PCOS, and to see if these outcomes differ by specific agent used for OI. STUDY DESIGN This prospective cohort analysis was from data collected from participants in the Pregnancy in Polycystic Ovary Syndrome II (PPCOSII) clinical trial conducted by the Reproductive Medicine Network. In PPCOSII, 750 women with PCOS and infertility were randomized to either clomiphene citrate or letrozole for OI for 1-5 cycles or until pregnancy occurred. Cox regression and modified Poisson regression, Chi-square and Student's t or Wilcoxon tests were applied. Outcomes of interest were live birth and clinical pregnancy rates, and pregnancy complications. Having MetS was defined by the presence of at least 3 out of 5 cardiometabolic risk factors (waist circumference > 88cm, low high-density lipoprotein cholesterol < 50mg/dL, triglycerides ≥ 150mg/dL, systolic BP ≥ 130 or diastolic BP ≥ 85 mmHg, and fasting glucose > 100mg/dl). We also used a continuous MetS Z-score. BMI categories were defined as normal (BMI < 25 kg/m2), high (25 to 35 kg/m2), and very high (> 35 kg/m2). RESULTS Fewer women achieved a clinical pregnancy (20.5% vs. 29.7%, p=.007) or had a live birth (16.5% vs. 27%, p=.001) in the presence of MetS. Early pregnancy losses were not different by MetS status. At least one pregnancy complication occurred more often with MetS, 61.9% (26/42) compared to 44.4% (59/133) (p=.05) without it. Gestational diabetes (35.7% vs. 18.2 %, p=.02) and macrosomia (21.4% vs. 8.3%, p=.02) were more common in the presence of MetS. After adjustment for other potential confounders, the live birth rate ratio for a one-unit change in the MetS z-score was 0.89 (95% CI 0.79, 1.00, p=.04) for those whose BMI was 25-35 kg/m2 . For the very high BMI subgroup (>35 kg/m2) the independent effects of MetS from obesity were harder to discern. The live birth rate was higher with letrozole, although MetS had a different detrimental effect by medication given. The overall incidence of pregnancy complications was high ( ∼ 49%) in PPCOSII, and similar with either agent. Letrozole was associated with more obstetrical complications in the presence of MetS and clomiphene was associated with a lower live birth rate when MetS was present. CONCLUSIONS MetS is a risk factor that lowers the live birth rate with OI for women with PCOS independent of obesity, and it is particularly associated with a lower live birth rate for clomiphene compared to letrozole users. It is also a risk factor for pregnancy complications for obese letrozole users. Having the MetS is a risk factor for gestational diabetes and macrosomia.",2021,"Fewer women achieved a clinical pregnancy (20.5% vs. 29.7%, p=.007) or had a live birth (16.5% vs. 27%, p=.001) in the presence of MetS. Early pregnancy losses were not different by MetS status.","['Polycystic Ovary Syndrome', 'participants in the Pregnancy in Polycystic Ovary Syndrome II (PPCOSII) clinical trial conducted by the Reproductive Medicine Network', 'women with polycystic ovary syndrome (PCOS', 'women with PCOS undergoing ovulation induction (OI', '750 women with PCOS and infertility', 'obese women with PCOS', 'obese letrozole users']","['letrozole', 'clomiphene', 'Letrozole', 'clomiphene citrate or letrozole']","['MetS with OI live birth rate and pregnancy complications', 'live birth rate', 'obstetrical complications', 'live birth rate ratio', 'presence of MetS. Early pregnancy losses', 'live birth', 'pregnancy complication', 'clinical pregnancy', 'overall incidence of pregnancy complications', 'Gestational diabetes', 'BMI categories', 'live birth and clinical pregnancy rates, and pregnancy complications', 'macrosomia']","[{'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0242668', 'cui_str': 'Medicine, Reproductive'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029967', 'cui_str': 'Ovulation induction'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0009008', 'cui_str': 'Clomiphene'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene citrate'}]","[{'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0029967', 'cui_str': 'Ovulation induction'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0032962', 'cui_str': 'Complication of pregnancy'}, {'cui': 'C0178292', 'cui_str': 'Complication of pregnancy, childbirth and/or the puerperium'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C3830362', 'cui_str': 'Early Pregnancy Loss'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0158915', 'cui_str': 'Exceptionally large at birth'}]",750.0,0.115834,"Fewer women achieved a clinical pregnancy (20.5% vs. 29.7%, p=.007) or had a live birth (16.5% vs. 27%, p=.001) in the presence of MetS. Early pregnancy losses were not different by MetS status.","[{'ForeName': 'Sushila', 'Initials': 'S', 'LastName': 'Arya', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences Center, Oklahoma City, OK.'}, {'ForeName': 'Karl R', 'Initials': 'KR', 'LastName': 'Hansen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences Center, Oklahoma City, OK.'}, {'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'Peck', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences Center, Oklahoma City, OK; Department of Biostatistics and Epidemiology, University of Oklahoma Health Sciences Center.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wild', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences Center, Oklahoma City, OK; Department of Biostatistics and Epidemiology, University of Oklahoma Health Sciences Center.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2021.03.048'] 3791,33852780,Trial of Psilocybin versus Escitalopram for Depression.,"BACKGROUND Psilocybin may have antidepressant properties, but direct comparisons between psilocybin and established treatments for depression are lacking. METHODS In a phase 2, double-blind, randomized, controlled trial involving patients with long-standing, moderate-to-severe major depressive disorder, we compared psilocybin with escitalopram, a selective serotonin-reuptake inhibitor, over a 6-week period. Patients were assigned in a 1:1 ratio to receive two separate doses of 25 mg of psilocybin 3 weeks apart plus 6 weeks of daily placebo (psilocybin group) or two separate doses of 1 mg of psilocybin 3 weeks apart plus 6 weeks of daily oral escitalopram (escitalopram group); all the patients received psychological support. The primary outcome was the change from baseline in the score on the 16-item Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16; scores range from 0 to 27, with higher scores indicating greater depression) at week 6. There were 16 secondary outcomes, including QIDS-SR-16 response (defined as a reduction in score of >50%) and QIDS-SR-16 remission (defined as a score of ≤5) at week 6. RESULTS A total of 59 patients were enrolled; 30 were assigned to the psilocybin group and 29 to the escitalopram group. The mean scores on the QIDS-SR-16 at baseline were 14.5 in the psilocybin group and 16.4 in the escitalopram group. The mean (±SE) changes in the scores from baseline to week 6 were -8.0±1.0 points in the psilocybin group and -6.0±1.0 in the escitalopram group, for a between-group difference of 2.0 points (95% confidence interval [CI], -5.0 to 0.9) (P = 0.17). A QIDS-SR-16 response occurred in 70% of the patients in the psilocybin group and in 48% of those in the escitalopram group, for a between-group difference of 22 percentage points (95% CI, -3 to 48); QIDS-SR-16 remission occurred in 57% and 28%, respectively, for a between-group difference of 28 percentage points (95% CI, 2 to 54). Other secondary outcomes generally favored psilocybin over escitalopram, but the analyses were not corrected for multiple comparisons. The incidence of adverse events was similar in the trial groups. CONCLUSIONS On the basis of the change in depression scores on the QIDS-SR-16 at week 6, this trial did not show a significant difference in antidepressant effects between psilocybin and escitalopram in a selected group of patients. Secondary outcomes generally favored psilocybin over escitalopram, but the analyses of these outcomes lacked correction for multiple comparisons. Larger and longer trials are required to compare psilocybin with established antidepressants. (Funded by the Alexander Mosley Charitable Trust and Imperial College London's Centre for Psychedelic Research; ClinicalTrials.gov number, NCT03429075.).",2021,The mean scores on the QIDS-SR-16 at baseline were 14.5 in the psilocybin group and 16.4 in the escitalopram group.,"['A total of 59 patients were enrolled; 30', 'patients with long-standing, moderate-to-severe major depressive disorder']","['psilocybin with escitalopram, a selective serotonin-reuptake inhibitor', 'placebo (psilocybin group) or two separate doses of 1 mg of psilocybin 3 weeks apart plus 6 weeks of daily oral escitalopram (escitalopram group); all the patients received psychological support', 'psilocybin', 'Psilocybin']","['16-item Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16; scores range', 'antidepressant effects', 'QIDS-SR-16 remission', 'mean scores on the QIDS-SR-16', 'depression scores', 'psilocybin over escitalopram', 'adverse events', 'QIDS-SR-16 response', 'mean (±SE) changes']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}]","[{'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",59.0,0.30087,The mean scores on the QIDS-SR-16 at baseline were 14.5 in the psilocybin group and 16.4 in the escitalopram group.,"[{'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Carhart-Harris', 'Affiliation': 'From the Centre for Psychedelic Research, Department of Brain Sciences, Faculty of Medicine, Imperial College London, London.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Giribaldi', 'Affiliation': 'From the Centre for Psychedelic Research, Department of Brain Sciences, Faculty of Medicine, Imperial College London, London.'}, {'ForeName': 'Rosalind', 'Initials': 'R', 'LastName': 'Watts', 'Affiliation': 'From the Centre for Psychedelic Research, Department of Brain Sciences, Faculty of Medicine, Imperial College London, London.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Baker-Jones', 'Affiliation': 'From the Centre for Psychedelic Research, Department of Brain Sciences, Faculty of Medicine, Imperial College London, London.'}, {'ForeName': 'Ashleigh', 'Initials': 'A', 'LastName': 'Murphy-Beiner', 'Affiliation': 'From the Centre for Psychedelic Research, Department of Brain Sciences, Faculty of Medicine, Imperial College London, London.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Murphy', 'Affiliation': 'From the Centre for Psychedelic Research, Department of Brain Sciences, Faculty of Medicine, Imperial College London, London.'}, {'ForeName': 'Jonny', 'Initials': 'J', 'LastName': 'Martell', 'Affiliation': 'From the Centre for Psychedelic Research, Department of Brain Sciences, Faculty of Medicine, Imperial College London, London.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Blemings', 'Affiliation': 'From the Centre for Psychedelic Research, Department of Brain Sciences, Faculty of Medicine, Imperial College London, London.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Erritzoe', 'Affiliation': 'From the Centre for Psychedelic Research, Department of Brain Sciences, Faculty of Medicine, Imperial College London, London.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Nutt', 'Affiliation': 'From the Centre for Psychedelic Research, Department of Brain Sciences, Faculty of Medicine, Imperial College London, London.'}]",The New England journal of medicine,['10.1056/NEJMoa2032994'] 3792,33852768,Short-term multimodal prehabilitation improves functional capacity for colorectal cancer patients prior to surgery.,"AIM Evaluate feasibility and outcomes of a multimodal prehabiliation program in patients with stage I-III colorectal cancer (CRC) awaiting surgery. METHODS Patients scheduled for elective CRC resection at Concord Repatriation General Hospital were recruited from pre-admission clinic between January and November 2018. Participants received a 2-4 week prehabilitation program consisting of supervised exercise sessions, nurse-led phone support, and written nutritional information. Participants were assessed at baseline, pre-surgery, and 4 weeks post-surgery. RESULTS Twenty-two patients participated in the program: 55% male; median age 73 (56-86) years. Six (28%) required an interpreter. At baseline, 19 of 22 (86%) had at least one comorbidity. Median intervention length was 11.5 days (range 7-29). Participants attended 79% of scheduled exercise sessions (range 33-100%, mean 3.5 sessions) and 66% of nurse support calls (range 0-100%, mean 2.6 sessions). Between baseline and pre-surgery, participants reported increasing mean unsupervised moderate-intensity aerobic exercise from 17 (range 0-210) to 73 minutes/week (range 0-276) and mean vigorous-intensity aerobic exercise from 0 to 24 minutes/week (range 0-300). Resistance exercise sessions increased from 0.6 to 2.6 times/week. Mean 6-minute walk test distance increased by 48 meters (435-483 m) and 30-second ""sit to stand"" by 1.6 repetitions. Small improvements were seen in global quality of life and fatigue. Nutritional status and body composition remained unchanged. All participants were satisfied/strongly satisfied with the program and would recommend it to others. CONCLUSION Our multimodal prehabilitation program was feasible in CRC patients inclusive of those from non-English speaking backgrounds, with improvement in functional capacity before CRC surgery.",2021,"Mean 6-minute walk test distance increased by 48 meters (435-483 m) and 30-second ""sit to stand"" by 1.6 repetitions.","['patients with stage I-III colorectal cancer (CRC) awaiting surgery', 'colorectal cancer patients prior to surgery', 'Patients scheduled for elective CRC resection at Concord Repatriation General Hospital were recruited from pre-admission clinic between January and November 2018', 'Twenty-two patients participated in the program: 55% male; median age 73 (56-86) years']","['multimodal prehabiliation program', 'scheduled exercise sessions', '2-4\xa0week prehabilitation program consisting of supervised exercise sessions, nurse-led phone support, and written nutritional information']","['mean vigorous-intensity aerobic exercise', 'mean unsupervised moderate-intensity aerobic exercise', 'functional capacity', 'Mean 6-minute walk test distance', 'Nutritional status and body composition', 'global quality of life and fatigue', 'Median intervention length', 'Resistance exercise sessions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0559269', 'cui_str': 'Pre-admission'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C5192101', 'cui_str': 'Prehabilitation'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0043266', 'cui_str': 'Writing'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",22.0,0.0707736,"Mean 6-minute walk test distance increased by 48 meters (435-483 m) and 30-second ""sit to stand"" by 1.6 repetitions.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Suen', 'Affiliation': 'Department of Colorectal Surgery, Concord Repatriation General Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Liew', 'Affiliation': 'Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jane D', 'Initials': 'JD', 'LastName': 'Turner', 'Affiliation': 'Concord Cancer Centre, Concord Repatriation General Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Khatri', 'Affiliation': 'Department of Colorectal Surgery, Concord Repatriation General Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Yanlan', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Colorectal Surgery, Concord Repatriation General Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kristy L', 'Initials': 'KL', 'LastName': 'Raso', 'Affiliation': 'Department of Nutrition and Dietetics, Concord Repatriation General Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Janette L', 'Initials': 'JL', 'LastName': 'Vardy', 'Affiliation': 'Concord Cancer Centre, Concord Repatriation General Hospital, Sydney, New South Wales, Australia.'}]",Asia-Pacific journal of clinical oncology,['10.1111/ajco.13564'] 3793,33852758,Effects of different remineralizing agents on color stability and surface characteristics of the teeth following vital bleaching.,"The aim of the study was to investigate the effects of various remineralizing agents on the color stability and surface characteristics of the teeth after vital bleaching. The extracted 96 human incisors were used for the study. Initially, the samples were randomly divided into two groups and exposed to in-office and at-home bleaching agents. Then, the groups were divided into six subgroups (n = 8), including the control group did not undergo remineralization after bleaching, according to five remineralizing agents (Gelato APF Gel, Remin Pro, Tooth Mousse, MI Paste Plus, Curodont Protect). Surface roughness was assessed at baseline, after bleaching and remineralization procedures. Color measurements of the samples were obtained at baseline, after bleaching and then after immersion in the staining solution following remineralization process. Scanning electron microscopy and atomic force microscopy (AFM) analyzes were carried out in order to examine the morphological changes on the surface of the enamel. The independent t-test, paired-samples t-test, and one-way ANOVA was used to compare the data and post-hoc LSD test to compare the difference among the study groups (α = .05). Surface roughness increased following in-office and at-home bleaching in all groups, and reduced after application of remineralizing agents in all groups. Significant differences were found among the groups with respect to changes in surface roughness and color values following treatment with remineralizing agents (p <.05). AFM analyses revealed increased surface roughness after bleaching and a reduction of rough surfaces following treatment with remineralizing agents. Remineralizing agents can be used to reduce postbleaching increase in surface roughness and to maintain color stability after bleaching.",2021,Significant differences were found among the groups with respect to changes in surface roughness and color values following treatment with remineralizing agents (p <.05).,[],"['control group did not undergo remineralization after bleaching, according to five remineralizing agents (Gelato APF Gel, Remin Pro, Tooth Mousse, MI Paste', 'remineralizing agents']","['Surface roughness', 'color stability and surface characteristics', 'surface roughness and color values', 'surface roughness']",[],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C3853221', 'cui_str': 'Gelato'}, {'cui': 'C3491832', 'cui_str': '(125I)APF'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C1956338', 'cui_str': 'tooth mousse'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0449588', 'cui_str': 'Surface characteristics'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",96.0,0.0129567,Significant differences were found among the groups with respect to changes in surface roughness and color values following treatment with remineralizing agents (p <.05).,"[{'ForeName': 'Kübra', 'Initials': 'K', 'LastName': 'Bilge', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dentistry, Firat University, Elazig, Turkey.'}, {'ForeName': 'Vahti', 'Initials': 'V', 'LastName': 'Kılıç', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dentistry, Firat University, Elazig, Turkey.'}]",Microscopy research and technique,['10.1002/jemt.23774'] 3794,33852752,Cortico-subcortical functional connectivity modifications in fatigued ms patients treated with fampridine and amantadine.,"BACKGROUND Fatigue in multiple sclerosis (MS) is common and disabling; medication efficacy is still not fully proven. Aim of this study was to investigate four-week modifications of fatigue severity in 45 relapsing-remitting MS patients following different symptomatic treatments, and concomitant resting state (RS) functional connectivity (FC) changes. METHODS Patients were randomly, blindly assigned to treatment with fampridine (n=15), amantadine (n=15) or placebo (n=15), and underwent clinical/3T RS fMRI at baseline (t0) and after four weeks (w4) of treatment. Fifteen healthy controls (HC) were also studied. Changes of modified fatigue impact scale (MFIS) and network RS FC were assessed. RESULTS In MS, abnormalities of network RS FC at t0 did not differ between treatment groups and correlated with fatigue severity. At w4, global and subscore MFISs decreased in all groups, with no time-by-treatment interaction. At w4, all patient groups had changes of RS FC in several networks, with significant time-by-treatment interactions in basal ganglia, sensorimotor and default-mode networks in fampridine patients vs the other groups, and in fronto-parietal network in amantadine patients. In fampridine-group, RS FC changes correlated with concurrently decreased MFIS (r range=-0.75 to 0.74, p range=0.003-0.05). CONCLUSIONS Fatigue improved in all MS groups, independently from treatment. Concomitant RS FC modifications were located in sensorimotor, inferior frontal and subcortical regions for fampridine and amantadine patients, and in associative sensory cortices for placebo patients.",2021,"Concomitant RS FC modifications were located in sensorimotor, inferior frontal and subcortical regions for fampridine and amantadine patients, and in associative sensory cortices for placebo patients.","['Patients', 'Fifteen healthy controls (HC', '45 relapsing-remitting MS patients']","['amantadine', 'fampridine', 'placebo', 'clinical/3T RS fMRI', 'fampridine and amantadine']","['MFIS', 'concomitant resting state (RS) functional connectivity (FC) changes', 'basal ganglia, sensorimotor and default-mode networks', 'RS FC changes', 'Concomitant RS FC modifications', 'fatigue severity', 'modified fatigue impact scale (MFIS) and network RS FC', 'MS, abnormalities of network RS FC', 'changes of RS FC', 'global and subscore MFISs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}]","[{'cui': 'C0002403', 'cui_str': 'Amantadine'}, {'cui': 'C0000477', 'cui_str': 'dalfampridine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2733557', 'cui_str': 'Fatigue impact scale'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0004781', 'cui_str': 'Basal ganglion structure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",15.0,0.0654016,"Concomitant RS FC modifications were located in sensorimotor, inferior frontal and subcortical regions for fampridine and amantadine patients, and in associative sensory cortices for placebo patients.","[{'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Rocca', 'Affiliation': 'Neuroimaging Research Unit, Division of Neuroscience, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Valsasina', 'Affiliation': 'Neuroimaging Research Unit, Division of Neuroscience, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Colombo', 'Affiliation': 'Neurology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Martinelli', 'Affiliation': 'Neurology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Filippi', 'Affiliation': 'Neuroimaging Research Unit, Division of Neuroscience, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}]",European journal of neurology,['10.1111/ene.14867'] 3795,33852738,Evaluation of antibacterial efficacy of Triphala toothwipes on oral Streptococcus mutans count in intellectually disabled children.,"AIM To evaluate antibacterial efficacy of Triphala toothwipes on oral Streptococcus mutans counts in intellectually disabled (ID) children. METHODS Twenty-seven children with a mild ID were randomly divided into two groups: A - Triphala and B - placebo group. Toothwipes were given to caregivers of children belonging to the respective groups, and were instructed to use them 1 h after their meals, twice a day for 7 days. Simplified Plaque index was recorded and plaque samples were collected for microbiological examination at baseline, 48 h, and 7 days. The obtained data were tabulated and analyzed. RESULTS Triphala group showed a statistically significant reduction of S. mutans after 48 h and 7 days. Both Triphala and placebo groups showed a statistically significant reduction in dental plaque after 48 h and 7 days. CONCLUSION Triphala toothwipes are effective against the oral S. mutans compared with placebo toothwipes, while both the toothwipes are equally effective in reducing dental plaque. Thus, Triphala toothwipes can be used as an adjunct aid along with routine oral hygiene practices in individuals who lack psychomotor skills or are dependent on others to maintain oral hygiene, including infants, preschoolers, geriatric population, and children with special health care needs.",2021,"Both Triphala and placebo groups showed a statistically significant reduction in dental plaque after 48 h and 7 days. ","['intellectually disabled children', 'intellectually disabled (ID) children', 'individuals who lack psychomotor skills or are dependent on others to maintain oral hygiene, including infants, preschoolers, geriatric population, and children with special health care needs', 'Twenty-seven children with a mild ID']","['placebo', ' Triphala and B - placebo', 'Triphala toothwipes']","['Simplified Plaque index', 'oral Streptococcus mutans counts', 'S. mutans', 'dental plaque', 'oral Streptococcus mutans count']","[{'cui': 'C0259916', 'cui_str': 'Child, Disabled'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1958185', 'cui_str': 'triphala'}]","[{'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}]",27.0,0.0575328,"Both Triphala and placebo groups showed a statistically significant reduction in dental plaque after 48 h and 7 days. ","[{'ForeName': 'Meghana Ajay', 'Initials': 'MA', 'LastName': 'Deshpande', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Sharad Pawar Dental College, Datta Meghe Institute of Medical Sciences, Wardha, Maharashtra, India.'}, {'ForeName': 'Sudhindra', 'Initials': 'S', 'LastName': 'Baliga', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Sharad Pawar Dental College, Datta Meghe Institute of Medical Sciences, Wardha, Maharashtra, India.'}, {'ForeName': 'Nilima', 'Initials': 'N', 'LastName': 'Thosar', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Sharad Pawar Dental College, Datta Meghe Institute of Medical Sciences, Wardha, Maharashtra, India.'}, {'ForeName': 'Nilesh', 'Initials': 'N', 'LastName': 'Rathi', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Sharad Pawar Dental College, Datta Meghe Institute of Medical Sciences, Wardha, Maharashtra, India.'}, {'ForeName': 'Shriramji', 'Initials': 'S', 'LastName': 'Jyothishi', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Sharad Pawar Dental College, Datta Meghe Institute of Medical Sciences, Wardha, Maharashtra, India.'}, {'ForeName': 'Pranjali Vilas', 'Initials': 'PV', 'LastName': 'Deulkar', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Sharad Pawar Dental College, Datta Meghe Institute of Medical Sciences, Wardha, Maharashtra, India.'}, {'ForeName': 'Sphurti Pramod', 'Initials': 'SP', 'LastName': 'Bane', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Sharad Pawar Dental College, Datta Meghe Institute of Medical Sciences, Wardha, Maharashtra, India.'}]","Special care in dentistry : official publication of the American Association of Hospital Dentists, the Academy of Dentistry for the Handicapped, and the American Society for Geriatric Dentistry",['10.1111/scd.12597'] 3796,33852732,Novel application of biofortified crops: consumer acceptance of pasta from yellow cassava and leafy vegetables.,"BACKGROUND Newly developed yellow biofortified cassava has been adjudged as a cost-effective solution to vitamin A deficiency in low- and middle-income countries with high cassava intake such as Nigeria. In this study, yellow cassava was developed into a novel pasta enriched with amaranth vegetable and tested among consumers. Attitudes, perception, motives for consumption and perceived barriers were ascertained using focus group discussions and randomised face-to-face interviews, while liking, preference and ranking of the novel food was established through consumer sensory perception. RESULTS Willingness to consume the new food, low food neophobia (32%), a health-driven consumption pattern, as well as an appreciable acceptance for the developed pasta, was established among the consumers. Ugwu (Telfairia occidentalis) was found to be the most preferred leafy vegetable. The yellow cassava pasta was ranked better than the conventional white cassava. CONCLUSION This study shows new avenues to valorise yellow cassava by which nutrition security can be improved in low- and middle-income countries of Africa. This article is protected by copyright. All rights reserved.",2021,"RESULTS Willingness to consume the new food, low food neophobia (32%), a health-driven consumption pattern, as well as an appreciable acceptance for the developed pasta, was established among the consumers.",[],[],"['Attitudes, perception, motives for consumption and perceived barriers']",[],[],"[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]",,0.0856983,"RESULTS Willingness to consume the new food, low food neophobia (32%), a health-driven consumption pattern, as well as an appreciable acceptance for the developed pasta, was established among the consumers.","[{'ForeName': 'Oluranti M', 'Initials': 'OM', 'LastName': 'Lawal', 'Affiliation': 'Wageningen University and Research, 6700VB, Wageningen, Netherlands.'}, {'ForeName': 'Elise F', 'Initials': 'EF', 'LastName': 'Talsma', 'Affiliation': 'Wageningen University and Research, 6700VB, Wageningen, Netherlands.'}, {'ForeName': 'Evert-Jan', 'Initials': 'EJ', 'LastName': 'Bakker', 'Affiliation': 'Wageningen University and Research, 6700VB, Wageningen, Netherlands.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Fogliano', 'Affiliation': 'Wageningen University and Research, 6700VB, Wageningen, Netherlands.'}, {'ForeName': 'Anita R', 'Initials': 'AR', 'LastName': 'Linnemann', 'Affiliation': 'Wageningen University and Research, 6700VB, Wageningen, Netherlands.'}]",Journal of the science of food and agriculture,['10.1002/jsfa.11259'] 3797,33852730,Pilot Randomized Clinical Trial of a Text Messaging-Based Intervention for Smoking Cessation Among Young People Experiencing Homelessness.,"INTRODUCTION Smoking rates are alarmingly high among young people experiencing homelessness (YEH), yet there are no evidence-based cessation programs for this population. This paper presents results from a pilot evaluation of a text messaging-based smoking cessation treatment, as an adjunct to brief group cessation counseling, to improve abstinence rates among 18-25 year old smokers experiencing homelessness. The goal of this study was to estimate effect sizes for a larger trial and it was not powered to detect group differences. METHODS YEH smokers who had a working cell phone with them at recruitment were randomized to receive a group counseling session, nicotine patches, and written material on quitting (n=37) or a similar program that also included a 6-week automated text messaging intervention (TMI) to provide ongoing support for quitting (n=40). Smoking outcomes were evaluated through a 90-day follow-up. RESULTS 7-day point prevalence abstinence at 90-day follow-up was higher in the TMI condition than standard condition (17.50% vs. 8.11%, respectively; Cohen's h=.37); however, the 90-day continuous abstinence rate was not statistically different from zero in either condition. Reductions in the number of days smoked in the past 30 days from baseline to follow-up were greater in the TMI condition than the standard condition (-14.24 vs. -8.62, respectively; Cohen's d=.49). CONCLUSIONS Adding a 6-week TMI support to a brief group counseling and pharmacotherapy protocol holds promise for smoking reduction and abstinence among YEH smokers. Results indicate that further development and evaluation of the TMI in this population is warranted. IMPLICATIONS This is the first study to evaluate the feasibility of using a text messaging-based intervention (TMI) for behavior change with 18-25 year olds experiencing homelessness, and more specifically, the first to test a TMI to provide ongoing support for smoking cessation. Small to medium effect sizes for the TMI are promising in terms of implementing a TMI using participants' own cell phones, as well as the efficacy of this approach as an adjunct to standard care (brief group counseling and pharmacotherapy) for smoking cessation among young people experiencing homelessness.",2021,"7-day point prevalence abstinence at 90-day follow-up was higher in the TMI condition than standard condition (17.50% vs. 8.11%, respectively;","['young people experiencing homelessness (YEH', '18-25 year old smokers experiencing homelessness', 'YEH smokers who had a working cell phone with them at recruitment', 'young people experiencing homelessness', 'Young People Experiencing Homelessness']","['standard care (brief group counseling and pharmacotherapy', 'text messaging-based intervention (TMI', 'text messaging-based smoking cessation treatment', 'group counseling session, nicotine patches, and written material on quitting (n=37) or a similar program that also included a 6-week automated text messaging intervention (TMI) to provide ongoing support for quitting', 'Text Messaging-Based Intervention for Smoking Cessation']","['abstinence rates', '90-day continuous abstinence rate', '7-day point prevalence abstinence', 'number of days smoked']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C1136359', 'cui_str': 'Cellular Phone'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0237547', 'cui_str': 'Group counseling'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}]",,0.0211961,"7-day point prevalence abstinence at 90-day follow-up was higher in the TMI condition than standard condition (17.50% vs. 8.11%, respectively;","[{'ForeName': 'Joan S', 'Initials': 'JS', 'LastName': 'Tucker', 'Affiliation': 'RAND Corporation; Santa Monica, CA.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Linnemayr', 'Affiliation': 'RAND Corporation; Santa Monica, CA.'}, {'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Pedersen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Keck School of Medicine, University of Southern California, Los Angeles CA.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Shadel', 'Affiliation': 'RAND Corporation, Suite, Pittsburgh, PA.'}, {'ForeName': 'Rushil', 'Initials': 'R', 'LastName': 'Zutshi', 'Affiliation': 'RAND Corporation; Santa Monica, CA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'DeYoreo', 'Affiliation': 'RAND Corporation; Santa Monica, CA.'}, {'ForeName': 'Irineo', 'Initials': 'I', 'LastName': 'Cabreros', 'Affiliation': 'RAND Corporation; Santa Monica, CA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntab055'] 3798,33852722,Acceptance and commitment therapy for late-life treatment-resistant generalised anxiety disorder: a feasibility study.,"BACKGROUND Generalised anxiety disorder (GAD) is the most common anxiety disorder in older people. First-line management includes pharmacological and psychological therapies, but many do not find these effective or acceptable. Little is known about how to manage treatment-resistant generalised anxiety disorder (TR-GAD) in older people. OBJECTIVES To examine the acceptability, feasibility and preliminary estimates of the effectiveness of acceptance and commitment therapy (ACT) for older people with TR-GAD. PARTICIPANTS People aged ≥65 years with TR-GAD (defined as not responding to GAD treatment, tolerate it or refused treatment) recruited from primary and secondary care services and the community. INTERVENTION Participants received up to 16 one-to-one sessions of ACT, developed specifically for older people with TR-GAD, in addition to usual care. MEASUREMENTS Co-primary outcomes were feasibility (defined as recruitment of ≥32 participants and retention of ≥60% at follow-up) and acceptability (defined as participants attending ≥10 sessions and scoring ≥21/30 on the satisfaction with therapy subscale). Secondary outcomes included measures of anxiety, worry, depression and psychological flexibility (assessed at 0 and 20 weeks). RESULTS Thirty-seven participants were recruited, 30 (81%) were retained and 26 (70%) attended ≥10 sessions. A total of 18/30 (60%) participants scored ≥21/30 on the satisfaction with therapy subscale. There was preliminary evidence suggesting that ACT may improve anxiety, depression and psychological flexibility. CONCLUSIONS There was evidence of good feasibility and acceptability, although satisfaction with therapy scores suggested that further refinement of the intervention may be necessary. Results indicate that a larger-scale randomised controlled trial of ACT for TR-GAD is feasible and warranted.",2021,"To examine the acceptability, feasibility and preliminary estimates of the effectiveness of acceptance and commitment therapy (ACT) for older people with TR-GAD. ","['People aged ≥65\xa0years with TR-GAD (defined as not responding to GAD treatment, tolerate it or refused treatment) recruited from primary and secondary care services and the community', 'older people with TR-GAD', 'Thirty-seven participants were recruited, 30 (81%) were retained and 26 (70%) attended ≥10 sessions', 'late-life treatment-resistant generalised anxiety disorder']","['ACT', 'acceptance and commitment therapy (ACT', 'Participants received up to 16 one-to-one sessions of ACT']","['satisfaction with therapy subscale', 'anxiety, depression and psychological flexibility', 'measures of anxiety, worry, depression and psychological flexibility (assessed at 0 and 20\xa0weeks']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}]","[{'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0547043', 'cui_str': 'Up'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0439230', 'cui_str': 'week'}]",37.0,0.0667934,"To examine the acceptability, feasibility and preliminary estimates of the effectiveness of acceptance and commitment therapy (ACT) for older people with TR-GAD. ","[{'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Gould', 'Affiliation': 'Division of Psychiatry, Faculty of Brain Sciences, University College London, London, UK.'}, {'ForeName': 'Julie Loebach', 'Initials': 'JL', 'LastName': 'Wetherell', 'Affiliation': 'Mental Health Service, VA San Diego Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Kimona', 'Affiliation': 'Division of Psychiatry, Faculty of Brain Sciences, University College London, London, UK.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Serfaty', 'Affiliation': 'Division of Psychiatry, Faculty of Brain Sciences, University College London, London, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Division of Psychiatry, Faculty of Brain Sciences, University College London, London, UK.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Graham', 'Affiliation': ""School of Psychology, Queen's University Belfast, Belfast, Northern Ireland.""}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Lawrence', 'Affiliation': ""Health Services and Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Gill', 'Initials': 'G', 'LastName': 'Livingston', 'Affiliation': 'Division of Psychiatry, Faculty of Brain Sciences, University College London, London, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Wilkinson', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Walters', 'Affiliation': 'Department of Primary Care and Population Health, University College London, London, UK.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Le Novere', 'Affiliation': 'Department of Primary Care and Population Health, University College London, London, UK.'}, {'ForeName': 'Iracema', 'Initials': 'I', 'LastName': 'Leroi', 'Affiliation': 'Global Brain Health Institute, School of Medicine, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Barber', 'Affiliation': 'Centre for Health of the Elderly, Campus for Ageing and Vitality, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': 'Clinical Trials Research Unit, School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Cook', 'Affiliation': 'The Bexleyheath Centre, Oxleas NHS Foundation Trust, Bexleyheath, UK.'}, {'ForeName': 'Viviana M', 'Initials': 'VM', 'LastName': 'Wuthrich', 'Affiliation': 'Department of Psychology, Centre for Emotional Health, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Howard', 'Affiliation': 'Division of Psychiatry, Faculty of Brain Sciences, University College London, London, UK.'}]",Age and ageing,['10.1093/ageing/afab059'] 3799,33852720,Growth Hormone Releasing Hormone Reduces Circulating Markers of Immune Activation in Parallel with Effects on Hepatic Immune Pathways in Individuals with HIV-Infection and Nonalcoholic Fatty Liver Disease.,"BACKGROUND The growth hormone (GH)/insulin-like growth factor-1 (IGF-1) axis modulates critical metabolic pathways; however, little is known regarding effects of augmenting pulsatile GH secretion on immune function in humans. This study used proteomics and gene set enrichment analysis to assess effects of a GH releasing hormone (GHRH) analog, tesamorelin, on circulating immune markers and liver tissue in people with HIV (PWH) and NAFLD. METHODS 92 biomarkers associated with immunity, chemotaxis, and metabolism were measured in plasma samples from 61 PWH with NAFLD who participated in a double-blind, randomized trial of tesamorelin versus placebo for 12 months. Gene set enrichment analysis was performed on serial liver biopsies targeted to immune pathways. RESULTS Tesamorelin, compared to placebo, decreased interconnected proteins related to cytotoxic T-cell and monocyte activation. Circulating concentrations of 13 proteins were significantly decreased, and no proteins increased, by tesamorelin. These included four chemokines (CCL3, CCL4, CCL13 [MCP4], IL8 [CXCL8]), two cytokines (IL-10 and CSF-1), and four T-cell associated molecules (CD8A, CRTAM, GZMA, ADGRG1), as well as ARG1, Gal-9, and HGF. Network analysis indicated close interaction among the gene pathways responsible for these proteins, with imputational analyses suggesting down regulation of a closely related cluster of immune pathways. Targeted transcriptomics using liver tissue confirmed a significant end-organ signal of down-regulated immune activation pathways. CONCLUSIONS Long-term treatment with a GHRH analog reduced markers of T-cell and monocyte/macrophage activity, suggesting that augmentation of the GH axis may ameliorate immune activation in an HIV population with metabolic dysregulation, systemic and end organ inflammation.",2021,"Circulating concentrations of 13 proteins were significantly decreased, and no proteins increased, by tesamorelin.","['92 biomarkers associated with immunity, chemotaxis, and metabolism were measured in plasma samples from 61 PWH with NAFLD who participated in a double-blind, randomized trial of', 'people with HIV (PWH) and NAFLD', 'Individuals with HIV-Infection and Nonalcoholic Fatty Liver Disease']","['GH releasing hormone (GHRH) analog, tesamorelin', 'placebo', 'tesamorelin versus placebo', 'Growth Hormone Releasing Hormone']","['cytotoxic T-cell and monocyte activation', 'Circulating concentrations of 13 proteins', 'chemokines (CCL3, CCL4, CCL13 [MCP4], IL8 [CXCL8]), two cytokines (IL-10 and CSF-1), and four T-cell associated molecules (CD8A, CRTAM, GZMA, ADGRG1), as well as ARG1, Gal-9, and HGF']","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0020964', 'cui_str': 'Immune status'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}]","[{'cui': 'C0037668', 'cui_str': 'Somatotropin releasing factor'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C1876200', 'cui_str': 'tesamorelin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0039195', 'cui_str': 'Cytotoxic T lymphocyte'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C1871788', 'cui_str': 'CCL3 protein, human'}, {'cui': 'C0007022', 'cui_str': 'Carbon tetrachloride'}, {'cui': 'C0390071', 'cui_str': 'chemokine (C-C motif) ligand 13, human'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0079784', 'cui_str': 'Colony-stimulating factor, macrophage'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C0914468', 'cui_str': 'class-I restricted T cell-associated molecule'}, {'cui': 'C0766915', 'cui_str': 'GPR56 protein, human'}, {'cui': 'C0537111', 'cui_str': 'LGALS9 protein, human'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",13.0,0.278888,"Circulating concentrations of 13 proteins were significantly decreased, and no proteins increased, by tesamorelin.","[{'ForeName': 'Takara L', 'Initials': 'TL', 'LastName': 'Stanley', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital (MGH) and Harvard Medical School (HMS), Boston, MA, USA.'}, {'ForeName': 'Lindsay T', 'Initials': 'LT', 'LastName': 'Fourman', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital (MGH) and Harvard Medical School (HMS), Boston, MA, USA.'}, {'ForeName': 'Lai Ping', 'Initials': 'LP', 'LastName': 'Wong', 'Affiliation': 'MGH Department of Molecular Biology and HMS, Boston, MA, USA.'}, {'ForeName': 'Ruslan', 'Initials': 'R', 'LastName': 'Sadreyev', 'Affiliation': 'MGH Department of Molecular Biology and HMS, Boston, MA, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Billingsley', 'Affiliation': 'Harvard Chan Bioinformatics Core, Department of Biostatistics, Harvard School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Meghan N', 'Initials': 'MN', 'LastName': 'Feldpausch', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital (MGH) and Harvard Medical School (HMS), Boston, MA, USA.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Zheng', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital (MGH) and Harvard Medical School (HMS), Boston, MA, USA.'}, {'ForeName': 'Chelsea S', 'Initials': 'CS', 'LastName': 'Pan', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital (MGH) and Harvard Medical School (HMS), Boston, MA, USA.'}, {'ForeName': 'Autumn', 'Initials': 'A', 'LastName': 'Boutin', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital (MGH) and Harvard Medical School (HMS), Boston, MA, USA.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Harvard Chan Bioinformatics Core, Department of Biostatistics, Harvard School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Kathleen E', 'Initials': 'KE', 'LastName': 'Corey', 'Affiliation': 'MGH Biostatistics Center, Boston, MA, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Torriani', 'Affiliation': 'Liver Center, Gastroenterology Division, MGH and HMS, Boston, MA, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kleiner', 'Affiliation': 'Department of Radiology, MGH and HMS, Boston, MA, USA.'}, {'ForeName': 'Raymond T', 'Initials': 'RT', 'LastName': 'Chung', 'Affiliation': 'MGH Biostatistics Center, Boston, MA, USA.'}, {'ForeName': 'Colleen M', 'Initials': 'CM', 'LastName': 'Hadigan', 'Affiliation': 'Laboratory of Pathology, National Cancer Institute, Bethesda, MD, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital (MGH) and Harvard Medical School (HMS), Boston, MA, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciab019'] 3800,33852718,Topical Imiquimod Does not Provide an Adjuvant Effect when Administered with Inactivated Influenza A/H5N1 Vaccine in Healthy Young Adults.,"BACKGROUND Safe, effective and easy to deploy adjuvants are needed for influenza pre-pandemic preparedness. Based on recent reports we hypothesized that pre-application of topical imiquimod followed by intradermal (ID) vaccination with monovalent inactivated influenza A/H5N1 vaccine (MIV A/H5N1) results in improved serologic responses. METHODS We randomized 50 healthy adults in a 1:1 ratio to receive topical imiquimod (Group 1) or control cream (Group 2) followed by ID injection of 9µg of the hemagglutinin (HA) MIV A/H5N1 in two doses, 21 days apart. Subjects were followed for safety and serologic responses as measured by the hemagglutination inhibition (HAI) and microneutralization (MN) assays. RESULTS Solicited and unsolicited adverse events were comparable between Groups 1 and 2, and were mostly mild to moderate in severity. At 21 days post dose 2, the geometric mean titers (GMTs) of HAI antibodies against the vaccine strain were 16.2 and 24.3 in Groups 1 and 2, respectively. The MN antibody GMTs were 9.3 and 10.7 in Groups 1 and 2, respectively. There were no significant differences in antibody levels between groups at study time points. CONCLUSION Topical imiquimod administration combined with ID MIV A/H5N1 was safe, but did not result in improved serologic responses to the vaccine.",2021,"Subjects were followed for safety and serologic responses as measured by the hemagglutination inhibition (HAI) and microneutralization (MN) assays. ","['Healthy Young Adults', '50 healthy adults in a 1:1 ratio to receive']","['control cream (Group 2) followed by ID injection of 9µg of the hemagglutinin', 'topical imiquimod followed by intradermal (ID) vaccination with monovalent inactivated influenza A/H5N1 vaccine (MIV A/H5N1', 'Topical Imiquimod', 'topical imiquimod', 'Inactivated Influenza A/H5N1 Vaccine']","['unsolicited adverse events', 'safety and serologic responses', 'serologic responses', 'antibody levels', 'geometric mean titers (GMTs) of HAI antibodies against the vaccine strain', 'MN antibody GMTs', 'hemagglutination inhibition (HAI) and microneutralization (MN) assays']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0021489', 'cui_str': 'Intradermal injection'}, {'cui': 'C0018909', 'cui_str': 'Hemagglutinin'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0165032', 'cui_str': 'imiquimod'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1615607', 'cui_str': 'Influenza A virus subtype H1N1'}, {'cui': 'C0016627', 'cui_str': 'Avian influenza'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205473', 'cui_str': 'Serologic'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination inhibition assay'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}]",50.0,0.0498603,"Subjects were followed for safety and serologic responses as measured by the hemagglutination inhibition (HAI) and microneutralization (MN) assays. ","[{'ForeName': 'Hana M', 'Initials': 'HM', 'LastName': 'El Sahly', 'Affiliation': 'Departments of Molecular Virology and Microbiology and Medicine, Baylor College of Medicine, Houston, Texas, United States of America.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Atmar', 'Affiliation': 'Departments of Molecular Virology and Microbiology and Medicine, Baylor College of Medicine, Houston, Texas, United States of America.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Sendra', 'Affiliation': 'The Emmes Company, Rockville, Maryland, United States of America.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Wegel', 'Affiliation': 'The Emmes Company, Rockville, Maryland, United States of America.'}, {'ForeName': 'Wendy A', 'Initials': 'WA', 'LastName': 'Keitel', 'Affiliation': 'Departments of Molecular Virology and Microbiology and Medicine, Baylor College of Medicine, Houston, Texas, United States of America.'}]",The Journal of infectious diseases,['10.1093/infdis/jiab206'] 3801,33852680,Contribution of an instructional module for lymph node evaluation: An experiment.,"OBJECTIVE to evaluate the contribution of an instructional module identifying the number and characteristics of lymph nodes by undergraduate nursing students. METHOD an experimental, randomized, controlled and masked study using an instructional module for intervention. The 68 students who made up the control group or the experimental group performed the prototype lymph node palpation in the initial and final phases, following the free registration of the characteristics and number of these structures. Between the phases, the instructional module (palpation prototype and a registration guide instrument) was applied to the experimental group. Descriptive statistics and mixed linear regression were used for analysis. RESULTS the experimental group showed greater accuracy (p<0.05) in the evaluation of the size, consistency, mobility and coalescence of the lymph nodes in the final phase when compared to the control; it also showed more chances to correctly evaluate the consistency ( OR 45,26; 95% CI<7,74>‡<264.54> p<0.0001), mobility (OR 55.95; CI 95% 12.45 - 251.60; p<0.0001) and size (OR 25.64; CI 95% 3.92 - 160.2; p=0.0002) of the lymph nodes. CONCLUSION the results reinforce the contribution of the instructional module to increase the knowledge of nursing students about the evaluation of lymph nodes.",2021,"the experimental group showed greater accuracy (p<0.05) in the evaluation of the size, consistency, mobility and coalescence of the lymph nodes in the final phase when compared to the control; it also showed more chances to correctly evaluate the consistency ( OR 45,26; 95% CI<7,74>‡<264.54> p<0.0001), mobility (OR 55.95; CI 95% 12.45 - 251.60; p<0.0001) and size (OR 25.64; CI 95% 3.92 - 160.2; p=0.0002) of the lymph nodes. ","['68 students who made up the control group or the experimental group performed the', 'undergraduate nursing students']",['prototype lymph node palpation'],"['size, consistency, mobility and coalescence of the lymph nodes', 'mobility']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}]","[{'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}]",,0.072593,"the experimental group showed greater accuracy (p<0.05) in the evaluation of the size, consistency, mobility and coalescence of the lymph nodes in the final phase when compared to the control; it also showed more chances to correctly evaluate the consistency ( OR 45,26; 95% CI<7,74>‡<264.54> p<0.0001), mobility (OR 55.95; CI 95% 12.45 - 251.60; p<0.0001) and size (OR 25.64; CI 95% 3.92 - 160.2; p=0.0002) of the lymph nodes. ","[{'ForeName': 'Francine Lima', 'Initials': 'FL', 'LastName': 'Fulquini', 'Affiliation': 'Universidade de São Paulo, Escola de Enfermagem de Ribeirão Preto, PAHO/WHO Collaborating Centre for Nursing Research Development, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Cristina Mara', 'Initials': 'CM', 'LastName': 'Zamarioli', 'Affiliation': 'Universidade de São Paulo, Escola de Enfermagem de Ribeirão Preto, PAHO/WHO Collaborating Centre for Nursing Research Development, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Bárbara', 'Initials': 'B', 'LastName': 'Gadioli', 'Affiliation': 'Universidade de São Paulo, Escola de Enfermagem de Ribeirão Preto, PAHO/WHO Collaborating Centre for Nursing Research Development, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Kusumota', 'Affiliation': 'Universidade de São Paulo, Escola de Enfermagem de Ribeirão Preto, PAHO/WHO Collaborating Centre for Nursing Research Development, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Fernanda Raphael Escobar', 'Initials': 'FRE', 'LastName': 'Gimenes', 'Affiliation': 'Universidade de São Paulo, Escola de Enfermagem de Ribeirão Preto, PAHO/WHO Collaborating Centre for Nursing Research Development, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Emília Campos de', 'Initials': 'EC', 'LastName': 'Carvalho', 'Affiliation': 'Universidade de São Paulo, Escola de Enfermagem de Ribeirão Preto, PAHO/WHO Collaborating Centre for Nursing Research Development, Ribeirão Preto, SP, Brazil.'}]",Revista latino-americana de enfermagem,['10.1590/1518-8345.4166.3408'] 3802,33852655,Ocular motility changes after inferomedial wall and balanced medial plus lateral wall orbital decompression in Graves' orbitopathy: a randomized prospective comparative study.,"OBJECTIVES To compare the surgical outcomes of inferomedial wall orbital decompression (IM-OD) and balanced medial plus lateral wall orbital decompression (ML-OD) in patients with inactive Graves' orbitopathy (GO) with regard to exophthalmos reduction and ocular motility abnormalities. METHODS Forty-two patients with inactive GO eligible for OD were randomly assigned to either the IM-OD or ML-OD groups. Pre and postoperative evaluations included Hertel exophthalmometry, sensory, and motor extraocular motility assessment, standardized photographs in the nine gaze positions, and computed tomography (CT) of the orbits. ClinicalTrials.gov: NCT03278964. RESULTS Exophthalmometry reduction was statistically significant in both groups (p<0.001), but was greater in the ML-OD group (p=0.010). New-onset esotropia occurred in 11.1% and 23.5% of patients who underwent IM-OD and ML-OD, respectively, with no statistically significant difference in the frequency of pre and postoperative strabismus in either group. The mean increase in preoperative esotropia was 24±6.9 and 12±8.8 prism diopters in patients who underwent IM-OD and ML-OD, respectively. In the IM-OD group, abduction and elevation worsened at the first (p<0.05) and third (p<0.05) postoperative visits but were restored at 6 months. The versions did not change postoperatively with ML-OD. The preoperative CT-measured medial rectus muscle area predicted new-onset strabismus (p=0.023). Significant postoperative medial rectus muscle enlargement occurred in both groups (p<0.001). Restriction in elevation and abduction was significantly associated with enlarged inferior (p=0.007) and medial rectus muscle areas (p=0.002). CONCLUSIONS IM-OD is as safe as ML-OD with regard to new-onset strabismus, and represents a good alternative for patients who do not require significant exophthalmos reduction. ML-OD offers greater exophthalmos reduction and smoother postoperative recovery. Patients with preoperative enlarged medial rectus muscle on CT are at risk for new-onset esotropia, and preoperative esotropia is likely to increase after OD.",2021,"In the IM-OD group, abduction and elevation worsened at the first (p<0.05) and third (p<0.05) postoperative visits but were restored at 6 months.","[""patients with inactive Graves' orbitopathy (GO) with regard to exophthalmos reduction and ocular motility abnormalities"", 'Forty-two patients with inactive GO eligible for OD']","['IM-OD or ML-OD', 'ML-OD', 'inferomedial wall and balanced medial plus lateral wall orbital decompression', 'inferomedial wall orbital decompression (IM-OD) and balanced medial plus lateral wall orbital decompression (ML-OD']","['postoperative visits', 'preoperative CT-measured medial rectus muscle area predicted new-onset strabismus', 'Hertel exophthalmometry, sensory, and motor extraocular motility assessment, standardized photographs in the nine gaze positions, and computed tomography (CT) of the orbits', 'abduction and elevation', 'Significant postoperative medial rectus muscle enlargement', 'frequency of pre and postoperative strabismus', 'Ocular motility changes', 'Exophthalmometry reduction', 'preoperative esotropia', 'medial rectus muscle areas', 'Restriction in elevation and abduction', 'New-onset esotropia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0015300', 'cui_str': 'Exophthalmos'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C4319566', 'cui_str': '42'}]","[{'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C3267044', 'cui_str': 'Orbital decompression'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0496828', 'cui_str': 'Malignant neoplasm of lateral wall of urinary bladder'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]","[{'cui': 'C0580703', 'cui_str': 'Postoperative visit'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0582820', 'cui_str': 'Medial rectus muscle structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0038379', 'cui_str': 'Strabismus'}, {'cui': 'C0200199', 'cui_str': 'Exophthalmometry'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0029180', 'cui_str': 'Orbital cavity'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0014877', 'cui_str': 'Esotropia'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]",42.0,0.0273913,"In the IM-OD group, abduction and elevation worsened at the first (p<0.05) and third (p<0.05) postoperative visits but were restored at 6 months.","[{'ForeName': 'Cristiane de Almeida', 'Initials': 'CA', 'LastName': 'Leite', 'Affiliation': 'Laboratorio de Investigacao em Oftalmologia (LIM 33), Divisao de Oftalmologia, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Thaís de Sousa', 'Initials': 'TS', 'LastName': 'Pereira', 'Affiliation': 'Laboratorio de Investigacao em Oftalmologia (LIM 33), Divisao de Oftalmologia, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Jeane', 'Initials': 'J', 'LastName': 'Chiang', 'Affiliation': 'Laboratorio de Investigacao em Oftalmologia (LIM 33), Divisao de Oftalmologia, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Rodrigo Bernal', 'Initials': 'RB', 'LastName': 'Moritz', 'Affiliation': 'Laboratorio de Investigacao em Oftalmologia (LIM 33), Divisao de Oftalmologia, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Allan Christian Pieroni', 'Initials': 'ACP', 'LastName': 'Gonçalves', 'Affiliation': 'Laboratorio de Investigacao em Oftalmologia (LIM 33), Divisao de Oftalmologia, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Mário Luiz Ribeiro', 'Initials': 'MLR', 'LastName': 'Monteiro', 'Affiliation': 'Laboratorio de Investigacao em Oftalmologia (LIM 33), Divisao de Oftalmologia, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}]","Clinics (Sao Paulo, Brazil)",['10.6061/clinics/2021/e2592'] 3803,33852647,"Correction: Sustained functional benefits after a single set of injections with abobotulinumtoxinA using a 2-mL injection volume in adults with cervical dystonia: 12-week results from a randomized, double-blind, placebo-controlled phase 3b study.",[This corrects the article DOI: 10.1371/journal.pone.0245827.].,2021,[This corrects the article DOI: 10.1371/journal.pone.0245827.].,['adults with cervical dystonia'],"['abobotulinumtoxinA', 'placebo']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0949445', 'cui_str': 'Cervical Dystonia'}]","[{'cui': 'C2719424', 'cui_str': 'AbobotulinumtoxinA'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.47304,[This corrects the article DOI: 10.1371/journal.pone.0245827.].,"[{'ForeName': 'Atul T', 'Initials': 'AT', 'LastName': 'Patel', 'Affiliation': ''}, {'ForeName': 'Mark F', 'Initials': 'MF', 'LastName': 'Lew', 'Affiliation': ''}, {'ForeName': 'Khashayar', 'Initials': 'K', 'LastName': 'Dashtipour', 'Affiliation': ''}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Isaacson', 'Affiliation': ''}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Hauser', 'Affiliation': ''}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Ondo', 'Affiliation': ''}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Maisonobe', 'Affiliation': ''}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Wietek', 'Affiliation': ''}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Rubin', 'Affiliation': ''}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Brashear', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0250475'] 3804,33852571,Mapping expanded prostate cancer index composite to EQ5D utilities to inform economic evaluations in prostate cancer: Secondary analysis of NRG/RTOG 0415.,"PURPOSE The Expanded Prostate Cancer Index Composite (EPIC) is the most commonly used patient reported outcome (PRO) tool in prostate cancer (PC) clinical trials, but health utilities associated with the different health states assessed with this tool are unknown, limiting our ability to perform cost-utility analyses. This study aimed to map EPIC tool to EuroQoL-5D-3L (EQ5D) to generate EQ5D health utilities. METHODS AND MATERIALS This is a secondary analysis of a prospective, randomized non-inferiority clinical trial, conducted between 04/2006 and 12/2009 at cancer centers across the United States, Canada, and Switzerland. Eligible patients included men >18 years with a known diagnosis of low-risk PC. Patient HRQoL data were collected using EPIC and health utilities were obtained using EQ5D. Data were divided into an estimation sample (n = 765, 70%) and a validation sample (n = 327, 30%). The mapping algorithms that capture the relationship between the instruments were estimated using ordinary least squares (OLS), Tobit, and two-part models. Five-fold cross-validation (in-sample) was used to compare the predictive performance of the estimated models. Final models were selected based on root mean square error (RMSE). RESULTS A total of 565 patients in the estimation sample had complete information on both EPIC and EQ5D questionnaires at baseline. Mean observed EQ5D utility was 0.90±0.13 (range: 0.28-1) with 55% of patients in full health. OLS models outperformed their counterpart Tobit and two-part models for all pre-determined model specifications. The best model fit was: ""EQ5D utility = 0.248541 + 0.000748*(Urinary Function) + 0.001134*(Urinary Bother) + 0.000968*(Hormonal Function) + 0.004404*(Hormonal Bother)- 0.376487*(Zubrod) + 0.003562*(Urinary Function*Zubrod)""; RMSE was 0.10462. CONCLUSIONS This is the first study to identify a comprehensive set of mapping algorithms to generate EQ5D utilities from EPIC domain/ sub-domain scores. The study results will help estimate quality-adjusted life-years in PC economic evaluations.",2021,"The best model fit was: ""EQ5D utility = 0.248541 + 0.000748*(Urinary Function) +","['prostate cancer', 'Eligible patients included men >18 years with a known diagnosis of low-risk PC', '565 patients in the estimation sample had', '04/2006 and 12/2009 at cancer centers across the United States, Canada, and Switzerland']",['EuroQoL-5D-3L (EQ5D'],"['Mean observed EQ5D utility', 'complete information on both EPIC and EQ5D questionnaires']","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}]","[{'cui': 'C0451150', 'cui_str': 'EuroQOL'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.104904,"The best model fit was: ""EQ5D utility = 0.248541 + 0.000748*(Urinary Function) +","[{'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Khairnar', 'Affiliation': 'Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore, MD, United States of America.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Pugh', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Philadelphia, PA, United States of America.'}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Sandler', 'Affiliation': 'Department of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, CA, United States of America.'}, {'ForeName': 'W Robert', 'Initials': 'WR', 'LastName': 'Lee', 'Affiliation': 'Department of Radiation Oncology, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Villalonga Olives', 'Affiliation': 'Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore, MD, United States of America.'}, {'ForeName': 'C Daniel', 'Initials': 'CD', 'LastName': 'Mullins', 'Affiliation': 'Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore, MD, United States of America.'}, {'ForeName': 'Francis B', 'Initials': 'FB', 'LastName': 'Palumbo', 'Affiliation': 'Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore, MD, United States of America.'}, {'ForeName': 'Deborah W', 'Initials': 'DW', 'LastName': 'Bruner', 'Affiliation': 'Department of Radiation Oncology, Emory University, Atlanta, GA, United States of America.'}, {'ForeName': 'Fadia T', 'Initials': 'FT', 'LastName': 'Shaya', 'Affiliation': 'Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore, MD, United States of America.'}, {'ForeName': 'Soren M', 'Initials': 'SM', 'LastName': 'Bentzen', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, MD, United States of America.'}, {'ForeName': 'Amit B', 'Initials': 'AB', 'LastName': 'Shah', 'Affiliation': 'WellSpan Health-York Cancer Center, York, PA, United States of America.'}, {'ForeName': 'Shawn C', 'Initials': 'SC', 'LastName': 'Malone', 'Affiliation': 'Ottawa Hospital and Cancer Center, Ottawa, ON, Canada.'}, {'ForeName': 'Jeff M', 'Initials': 'JM', 'LastName': 'Michalski', 'Affiliation': 'Department of Radiation Oncology, Washington University, St. Louis, MO, United States of America.'}, {'ForeName': 'Ian S', 'Initials': 'IS', 'LastName': 'Dayes', 'Affiliation': 'Juravinski Cancer Center at Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Samantha A', 'Initials': 'SA', 'LastName': 'Seaward', 'Affiliation': 'Kaiser Permanente Northern California, Oakland, CA, United States of America.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Albert', 'Affiliation': ""Saint Anne's Hospital, Fall River, MA, United States of America.""}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'Currey', 'Affiliation': 'Zablocki VAMC and the Medical College of Wisconsin, Milwaukee, WI, United States of America.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Pisansky', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic Rochester, Rochester, MN, United States of America.'}, {'ForeName': 'Yuhchyau', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, University of Rochester, Rochester, NY, United States of America.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Horwitz', 'Affiliation': 'Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, PA, United States of America.'}, {'ForeName': 'Albert S', 'Initials': 'AS', 'LastName': 'DeNittis', 'Affiliation': 'Department of Radiation Oncology, Main Line Health, Philadelphia, PA, United States of America.'}, {'ForeName': 'Felix Y', 'Initials': 'FY', 'LastName': 'Feng', 'Affiliation': 'Department of Radiation Oncology, University of California San Francisco, San Francisco, CA, United States of America.'}, {'ForeName': 'Mark V', 'Initials': 'MV', 'LastName': 'Mishra', 'Affiliation': 'Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, MD, United States of America.'}]",PloS one,['10.1371/journal.pone.0249123'] 3805,33852508,The role of nursing care in the type 2 diabetes treatment associated with chronic liver diseases.,"OBJECTIVE Diabetes is the fifth leading cause of death in the People's Republic of China. The aim of the article is to compare the effects of nursing care on the laboratory findings and ultrasound results of diabetic patients with chronic liver diseases (CLD) who were treated with antiglycemic drugs. METHODS Diabetic were patients treated with metformin hydrochloride in combination with gliclazide, pioglitazone hydrochloride, sitagliptin, exenatide or liraglutide. Non-alcoholic fatty liver disease (NAFLD) was evaluated by abdominal ultrasound, and fibrosis stages were evaluated at baseline and 8 months. All the patients were equally divided into two groups depending on the therapeutic approach. RESULTS The first group of patients additionally received nursing care, and the second group adhered to the prescribed therapy on their own. In total 90 patients, or 55.6%, had NAFLD at baseline, and its course was dependent upon changes in the weight (P = 0.009) and waist circumference (P = 0.012). The proportions of patients who demonstrated an ultrasonographic improvement in the control group were: 24 (56.8%) with gliclazide, 15 (41.3%) with pioglitazone hydrochloride, 28 (66.1%) with sitagliptin, 16 (79%) with exenatide and 15 (66.7%) with liraglutide (P = 0.2). For the group that received nursing care an ultrasonographic improvement was in: 29 (68.16%) with gliclazide, 18 (49.56%) with pioglitazone hydrochloride, 33 (79.32%) with sitagliptin, 19 (94.8%) with exenatide and 21 80.04% with liraglutide (P = 0.2). CONCLUSIONS Outcomes from the type 2 diabetes treatment paralleling of CLD were presented. Treatment of type 2 diabetes with pioglitazone hydrochloride, gliclazide, sitagliptin, liraglutide and exenatide was proven effective.",2021,"For the group that received nursing care an ultrasonographic improvement was in: 29 (68.16%) with gliclazide, 18 (49.56%) with pioglitazone hydrochloride, 33 (79.32%) with sitagliptin, 19 (94.8%) with exenatide and 21 80.04% with liraglutide (P = 0.2). ","['Diabetic were patients treated with', 'diabetic patients with chronic liver diseases (CLD) who were treated with antiglycemic drugs']","['pioglitazone hydrochloride, gliclazide, sitagliptin, liraglutide and exenatide', 'pioglitazone hydrochloride', 'metformin hydrochloride in combination with gliclazide, pioglitazone hydrochloride, sitagliptin, exenatide or liraglutide. Non-alcoholic fatty liver disease (NAFLD', 'gliclazide', 'nursing care', 'exenatide', 'liraglutide']","['ultrasonographic improvement', 'waist circumference']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0341439', 'cui_str': 'Chronic liver disease'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0872972', 'cui_str': 'Pioglitazone hydrochloride'}, {'cui': 'C0017631', 'cui_str': 'Gliclazide'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0770893', 'cui_str': 'Metformin hydrochloride'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0028678', 'cui_str': 'nursing'}]","[{'cui': 'C0455829', 'cui_str': 'Waist circumference'}]",90.0,0.0430878,"For the group that received nursing care an ultrasonographic improvement was in: 29 (68.16%) with gliclazide, 18 (49.56%) with pioglitazone hydrochloride, 33 (79.32%) with sitagliptin, 19 (94.8%) with exenatide and 21 80.04% with liraglutide (P = 0.2). ","[{'ForeName': 'Bai Yu', 'Initials': 'BY', 'LastName': 'Fu', 'Affiliation': 'Gastroenterology Department Nursing Department, The First Affiliated Hospital of Hainan Medical University, Haikou City, Hainan Province, China.'}, {'ForeName': 'Xue Jiao', 'Initials': 'XJ', 'LastName': 'Wang', 'Affiliation': ''}]",European journal of gastroenterology & hepatology,['10.1097/MEG.0000000000002150'] 3806,33852503,High levels of prevention-effective adherence to HIV pre-exposure prophylaxis (PrEP): An analysis of sub-study data from the EPIC-NSW trial.,"BACKGROUND Pre-exposure prophylaxis (PrEP) prevents HIV infection but relies on good adherence at times of risk, termed 'prevention-effective adherence'. Most studies assess adherence without reference to sexual behaviour, making it challenging to determine if poor adherence coincides with HIV risk. SETTING We examined data from a behavioural sub-study of a large-scale PrEP implementation trial in New South Wales, Australia. METHODS Trial participants completed optional, brief quarterly surveys, reporting number of pills taken and sexual behaviour with male partners for each day of the 'last full week' before each survey. Condomless sex (CLS) was defined as 'higher risk' for HIV when with HIV-positive men with detectable/unknown viral loads or unknown HIV status men. Adequate PrEP protection was defined as ≥4 pills for participants assigned male sex at birth and ≥6 pills for participants assigned female sex at birth (including transgender men). RESULTS Of 9596 participants dispensed PrEP, 4401 completed baseline and ≥1 follow-up survey. Participants reported on 12399 'last full weeks'; 7485 weeks (60.4%) involved CLS, and 2521 weeks (33.7% of CLS-weeks) involved higher risk CLS. There were 103 weeks in which participants did not have adequate PrEP protection and had higher risk CLS: 4.1% of higher risk CLS-weeks (n=103/2521), 1.4% of all CLS-weeks (n=103/7485), and 0.8% of all observed weeks (n=103/12399). CONCLUSIONS In a large PrEP trial, prevention-effective adherence to PrEP was very high at 99%. Our findings illustrate the importance of measuring pill-taking and sexual behaviour in the same period so that prevention-effective adherence can be better estimated.",2021,"Participants reported on 12399 'last full weeks'; 7485 weeks (60.4%) involved CLS, and 2521 weeks (33.7% of CLS-weeks) involved higher risk CLS.","[""Trial participants completed optional, brief quarterly surveys, reporting number of pills taken and sexual behaviour with male partners for each day of the 'last full week' before each survey"", 'New South Wales, Australia', '9596 participants dispensed PrEP, 4401 completed baseline and ≥1 follow-up survey', 'participants assigned male sex at birth and ≥6 pills for participants assigned female sex at birth (including transgender men']","['Pre-exposure prophylaxis (PrEP', 'HIV pre-exposure prophylaxis (PrEP']","['adequate PrEP protection', 'higher risk CLS']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C1096319', 'cui_str': 'Prophylaxis against HIV infection'}]","[{'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]",,0.183753,"Participants reported on 12399 'last full weeks'; 7485 weeks (60.4%) involved CLS, and 2521 weeks (33.7% of CLS-weeks) involved higher risk CLS.","[{'ForeName': 'Benjamin R', 'Initials': 'BR', 'LastName': 'Bavinton', 'Affiliation': 'Kirby Institute, UNSW Sydney Centre for Social Research in Health, UNSW Sydney Sydney Medical School - Westmead, University of Sydney Western Sydney Sexual Health Centre Macquarie University Department of Sexual Health Medicine and Sexual Assault Medical Service, Sydney Local Health District Central Clinical School, Sydney Medical School, University of Sydney East Sydney Doctors Sydney Sexual Health Centre.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Vaccher', 'Affiliation': ''}, {'ForeName': 'Fengyi', 'Initials': 'F', 'LastName': 'Jin', 'Affiliation': ''}, {'ForeName': 'Garrett P', 'Initials': 'GP', 'LastName': 'Prestage', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Holt', 'Affiliation': ''}, {'ForeName': 'Iryna B', 'Initials': 'IB', 'LastName': 'Zablotska-Manos', 'Affiliation': ''}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Guy', 'Affiliation': ''}, {'ForeName': 'Janaki', 'Initials': 'J', 'LastName': 'Amin', 'Affiliation': ''}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Templeton', 'Affiliation': ''}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Yeung', 'Affiliation': ''}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Hammoud', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Baker', 'Affiliation': ''}, {'ForeName': 'Nila', 'Initials': 'N', 'LastName': 'Dharan', 'Affiliation': ''}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'McNulty', 'Affiliation': ''}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Grulich', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002691'] 3807,33852498,The effect of high-dose versus low-dose epidural fentanyl on gastric emptying in nonfasted parturients: A double-blinded randomised controlled trial.,"BACKGROUND Epidural fentanyl doses above 100 μg have been shown, using the paracetamol absorption test, to reduce gastric emptying in fasted labouring women. OBJECTIVE To investigate the effect of fentanyl dose on gastric emptying in nonfasted labouring women using gastric ultrasonography. DESIGN A double-blinded randomised controlled study. SETTING A tertiary medical centre in Tel Aviv, Israel between 30 July 2020 and 11 October 2020. PATIENTS Eighty labouring women with cervical dilation 5 cm or less, at least 18 years age, at least 37 weeks gestation with a singleton pregnancy and cephalad foetus. INTERVENTIONS Women randomised to high (≥100 μg) or low (<100 μg) cumulative epidural fentanyl had ultrasound gastric content assessment, measuring antral cross-sectional area (CSA) at epidural placement and 2 h thereafter (T2  h). MAIN OUTCOME MEASURES The primary outcome was CSA at T2  h comparing high-dose versus low-dose fentanyl. Secondary outcomes included change in CSA between baseline and T2  h. Sub-group analysis compared stomach content at T2  h according to baseline stomach content, empty (CSA <381 mm2) or full (CSA ≥381 mm2), and high-dose versus low-dose fentanyl. RESULTS Data from 80 women were analysed; 63 had empty and 17 had full stomach at baseline. There was no significant difference in CSA at T2  h between high-dose, mean 335 ± SD 133 mm2, versus low-dose fentanyl, mean 335 ± SD 172 mm2, P = 0.991. Change in CSA baseline to T2  h was 46 ± SD 149 mm2 for high and 49 ± SD 163 mm2 for low-dose group, P = 0.931. The subgroup analysis according to baseline stomach content showed no statistically significant differences in CSA at T2  h. CONCLUSION The CSA at T2  h was similar for women who received high-dose versus low-dose epidural fentanyl, measured by ultrasound, in our nonfasted labouring cohort. TRIAL REGISTRATION Clinicaltrials.gov number: NCT04202887.",2021,"The CSA at T2  h was similar for women who received high-dose versus low-dose epidural fentanyl, measured by ultrasound, in our nonfasted labouring cohort. ","['nonfasted parturients', 'Eighty labouring women with cervical dilation 5\u200acm or less, at least 18\u200ayears age, at least 37\u200aweeks gestation with a singleton pregnancy and cephalad foetus', 'A tertiary medical centre in Tel Aviv, Israel between 30 July 2020 and 11 October 2020', 'Data from 80 women were analysed; 63 had empty and 17 had full stomach at baseline', 'fasted labouring women', 'nonfasted labouring women using gastric ultrasonography']","['fentanyl', 'high-dose versus low-dose epidural fentanyl']","['CSA', 'gastric emptying', 'ultrasound gastric content assessment, measuring antral cross-sectional area (CSA', 'change in CSA between baseline and T2\u200a h', 'CSA at T2']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205096', 'cui_str': 'Cephalic'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0039466', 'cui_str': 'Telugu language'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C1275733', 'cui_str': 'Low dose epidural'}]","[{'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0038352', 'cui_str': 'Gastric contents'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0293352', 'cui_str': 'Antral'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",80.0,0.563948,"The CSA at T2  h was similar for women who received high-dose versus low-dose epidural fentanyl, measured by ultrasound, in our nonfasted labouring cohort. ","[{'ForeName': 'Elisheva', 'Initials': 'E', 'LastName': 'Fiszer', 'Affiliation': 'From the Department of Anaesthesia, Intensive Care and Pain, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel (EF, BA, YB, CFW).'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Aptekman', 'Affiliation': ''}, {'ForeName': 'Yuval', 'Initials': 'Y', 'LastName': 'Baar', 'Affiliation': ''}, {'ForeName': 'Carolyn F', 'Initials': 'CF', 'LastName': 'Weiniger', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001514'] 3808,33852465,Ready-to-Use Micronized Human Acellular Dermal Matrix to Accelerate Wound Healing in Diabetic Foot Ulcers: A Prospective Randomized Pilot Study.,"OBJECTIVE To examine and report clinical outcomes of a ready-to-use micronized dermal matrix for diabetic foot ulcers (DFUs) and compare it to treatment with conventional negative-pressure wound therapy (NPWT) only. METHODS The researchers randomly allocated 30 DFUs Wagner grade 2 or higher from 30 adult patients into two groups. The control group (n = 15) was treated with conventional NPWT, and the experimental group (n = 15) was treated with micronized dermal matrix and NPWT. The researchers evaluated the following outcomes: granulation tissue formation, proportion of patients with closed or granulated wounds at 42 and 120 days, achievement of complete wound healing in the 6 months of follow-up, and intervals from enrollment to final surgical procedures. RESULTS All 15 wounds treated with the micronized matrix showed healthy granulation tissue without noticeable complications during follow-up. At 42 days, 46.7% of wounds in the experimental group had closed compared with 28.6% in the conventional NPWT group (P = .007). At 120 days, 86.7% of the experimental group had completely closed wounds, compared with 57.1% in the conventional therapy group (P = .040). During the 6-month follow-up period, 93.3% of the experimental group achieved complete wound healing compared with 85.7% of the conventional therapy group (P = .468). CONCLUSIONS The healing outcomes for DFUs in the experimental group were superior when micronized matrix treatment was combined with NPWT.",2021,"At 120 days, 86.7% of the experimental group had completely closed wounds, compared with 57.1% in the conventional therapy group (P = .040).","['Diabetic Foot Ulcers', 'diabetic foot ulcers (DFUs']","['micronized dermal matrix and NPWT', 'ready-to-use micronized dermal matrix', 'Micronized Human Acellular Dermal Matrix', 'conventional NPWT', 'conventional negative-pressure wound therapy (NPWT', 'micronized matrix']","['complete wound healing', 'healthy granulation tissue without noticeable complications', 'completely closed wounds', 'healing outcomes for DFUs']","[{'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}]","[{'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C3494272', 'cui_str': 'Acellular Dermal Matrix'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0018180', 'cui_str': 'Granulation tissue'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0679319', 'cui_str': 'Closed wound'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}]",30.0,0.00291419,"At 120 days, 86.7% of the experimental group had completely closed wounds, compared with 57.1% in the conventional therapy group (P = .040).","[{'ForeName': 'Hyung Min', 'Initials': 'HM', 'LastName': 'Hahn', 'Affiliation': 'At the Ajou University School of Medicine, Suwon, Republic of Korea, Hyung Min Hahn, MD, is Assistant Professor; Dong Hwan Lee, MD, is a Resident; Il Jae Lee, MD, PhD, is Associate Professor, Department of Plastic and Reconstructive Surgery. Acknowledgments: The authors thank Editage (www.editage.co.kr) for English language editing. This research was supported by a Korea Health Industry Development Institute grant to Ajou University Medical Center. The authors have disclosed no other financial relationships related to this article. Submitted May 28, 2020; accepted in revised form September 3, 2020.'}, {'ForeName': 'Dong Hwan', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Il Jae', 'Initials': 'IJ', 'LastName': 'Lee', 'Affiliation': ''}]",Advances in skin & wound care,['10.1097/01.ASW.0000741512.57300.6d'] 3809,33852380,A pilot investigation of the influence of a passive military exoskeleton on the performance of lab-simulated operational tasks.,"Occupational applicationsMilitary load carriage increases musculoskeletal injury risk and reduces performance, but is essential for operational effectiveness. Exoskeletons may play a role in reducing soldier burden. We found that wearing a customized passive exoskeleton during a military obstacle course decreased overall performance compared to a mass-matched control condition. Specifically, the ""Stairs and Ladder"" and ""Hatch and Tunnel"" obstacles were performed slower while wearing the exoskeleton. In contrast, similar mean completion times in the ""Casualty Drag,"" ""Sprint"" and ""Agility Run"" obstacles were found in both the exoskeleton and control conditions. Acceptability of equipment weight and torso stiffness were rated similarly across conditions, whereas the acceptability of overall performance was rated lowest while wearing the exoskeleton. The results of this preliminary investigation suggest that the time to complete operationally-relevant military obstacles was not improved by wearing a passive exoskeleton.Technical abstract Background: Passive exoskeletons may mitigate soldier burden when task demands are not modifiable. Purpose: To determine the potential effects of a customized passive exoskeleton on task completion time and acceptability during the Canadian Load Effects Assessment Program (Can-LEAP). Methods: Two male soldiers aged 20-25 years completed Can-LEAP, a course comprised of 10 military obstacles. Can-LEAP was completed prior to and following a 5 km march, while carrying 33 kg under four randomized experimental conditions, for a total of eight trials. These conditions varied in terms of whether the exoskeleton was used and the total load carried. Within-subject comparisons across experimental conditions and pre/post march were made for Can-LEAP completion time, obstacle completion time, and acceptability. Results: The total Can-LEAP time was longest while wearing the exoskeleton. The ""Stairs and Ladder"" and ""Hatch and Tunnel"" obstacles were performed slower in the exoskeleton condition than the control. Similar mean completion times were found between experimental conditions during ""Sprint"" and ""Agility Run"" obstacles (<1.6 s difference). Obstacle completion times pre/post march task were similar (<1.9 s difference). Acceptability across experimental condition were similar in terms of ratings of torso stiffness and weight, whereas overall performance was rated lowest while wearing the exoskeleton. Conclusions : A customized passive exoskeleton increased total Can-LEAP completion time compared to a mass-matched control condition. Obstacles with confined spaces had increased completion times when using the exoskeleton whereas carrying and running tasks had similar completion times across conditions.",2021,Obstacles with confined spaces had increased completion times when using the exoskeleton whereas carrying and running tasks had similar completion times across conditions.,"['Two male soldiers aged 20-25\u2009years completed Can-LEAP, a course comprised of 10 military obstacles']","['customized passive exoskeleton', 'passive military exoskeleton']","['Stairs and Ladder"" and ""Hatch and Tunnel"" obstacles', 'overall performance', 'Acceptability of equipment weight and torso stiffness', 'total Can-LEAP completion time', 'total Can-LEAP time', 'acceptability of overall performance', 'completion times']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0524647', 'cui_str': 'Soldiers'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}]","[{'cui': 'C0026126', 'cui_str': 'Military personnel'}]","[{'cui': 'C0336762', 'cui_str': 'Ladder'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",2.0,0.101985,Obstacles with confined spaces had increased completion times when using the exoskeleton whereas carrying and running tasks had similar completion times across conditions.,"[{'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Gruevski', 'Affiliation': 'School of Human Kinetics, Faculty of Health Sciences, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Ian J', 'Initials': 'IJ', 'LastName': 'Cameron', 'Affiliation': 'Operational Health and Performance Section, Defence Research and Development Canada, Toronto, Canada.'}, {'ForeName': 'Cerys', 'Initials': 'C', 'LastName': 'McGuinness', 'Affiliation': 'Operational Health and Performance Section, Defence Research and Development Canada, Toronto, Canada.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Sy', 'Affiliation': 'Operational Health and Performance Section, Defence Research and Development Canada, Toronto, Canada.'}, {'ForeName': 'Krista L', 'Initials': 'KL', 'LastName': 'Best', 'Affiliation': 'Department of Rehabilitation, Faculty of Medicine, Université Laval, Quebec City, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bouyer', 'Affiliation': 'Department of Rehabilitation, Faculty of Medicine, Université Laval, Quebec City, Canada.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Diamond-Ouellette', 'Affiliation': 'Centre for Interdisciplinary Research in Rehabilitation and Social Integration, Centre intégré universitaire de santé et de service sociaux de la Capitale-Nationale, Quebec City, Canada.'}, {'ForeName': 'Ryan B', 'Initials': 'RB', 'LastName': 'Graham', 'Affiliation': 'School of Human Kinetics, Faculty of Health Sciences, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Karakolis', 'Affiliation': 'Operational Health and Performance Section, Defence Research and Development Canada, Toronto, Canada.'}]",IISE transactions on occupational ergonomics and human factors,['10.1080/24725838.2021.1912852'] 3810,33852339,PARP Inhibitor in Platinum-Resistant Ovarian Cancer: Single-Center Real-World Experience.,"PURPOSE Poly (ADP-ribose) polymerase inhibitors (PARPi) have proven efficacy in treatment of BReast CAncer ( BRCA ) gene mutation-positive platinum-sensitive ovarian cancers. There is paucity of data for their role in platinum-resistant ovarian cancer (PROC). We report here retrospective analysis of outcome of PARPi treatment in a group of patients including those of PROC. PATIENTS AND METHODS We analyzed all consecutive patients who received PARPi. The efficacy of PARPi monotherapy was assessed in patients with relapsed high-grade serous ovarian carcinoma with g BRCA m. The drug was procured through compassionate program. Drugs (olaparib and talazoparib) were provided in capsule form. RESULTS Between July 1, 2015, and June 30, 2019, 28 patients with ovarian cancer received PARPi. At the time of data censoring (September 30, 2019), four (14.3%) patients are still on treatment. Median age was 54.5 years (range, 39-75 years). Median number of previous lines of chemotherapy received was three (range, 1-6). Eleven platinum-sensitive patients received the drug as maintenance (five in complete response and six in partial response after chemotherapy), whereas 17 (60.7%) had platinum-resistant progressive disease while starting the drug. In PROC, objective response rate (complete response plus partial response) was 47%, median progression-free survival was 8.2 months (5.3-11.3), and overall survival was 14.9 months (11.2-18.5). No new side effects were observed. CONCLUSION This is the first study from India evaluating PARPi in platinum-resistant ovarian cancer. This study suggests that PARPi is a viable treatment option in patients with PROC with gBRCAm. This should be further evaluated in randomized clinical trial.",2021,"No new side effects were observed. ","['patients with relapsed high-grade serous ovarian carcinoma with g BRCA m', 'We analyzed all consecutive patients who received', 'Median age was 54.5 years (range, 39-75 years', 'Platinum-Resistant Ovarian Cancer', 'a group of patients including those of PROC', 'platinum-resistant ovarian cancer', '28 patients with ovarian cancer received', 'patients with PROC with gBRCAm']","['PARPi monotherapy', 'PARPi', 'Poly (ADP-ribose) polymerase inhibitors (PARPi', 'Drugs (olaparib and talazoparib', 'PARP Inhibitor']","['objective response rate (complete response plus partial response', 'Median number of previous lines of chemotherapy', 'median progression-free survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0440743', 'cui_str': 'Serous'}, {'cui': 'C1140680', 'cui_str': 'Malignant tumor of ovary'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C1882413', 'cui_str': 'Nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor-containing product'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C4042960', 'cui_str': 'talazoparib'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",28.0,0.187031,"No new side effects were observed. ","[{'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Department of Medical Oncology, Dr BL Kapur Memorial Hospital, New Delhi, India.'}, {'ForeName': 'Saphalta', 'Initials': 'S', 'LastName': 'Baghmar', 'Affiliation': 'Department of Medical Oncology, Dr BL Kapur Memorial Hospital, New Delhi, India.'}, {'ForeName': 'Chandragouda', 'Initials': 'C', 'LastName': 'Dodagoudar', 'Affiliation': 'Department of Medical Oncology, Dr BL Kapur Memorial Hospital, New Delhi, India.'}, {'ForeName': 'Suhail', 'Initials': 'S', 'LastName': 'Qureshi', 'Affiliation': 'Department of Medical Oncology, Dr BL Kapur Memorial Hospital, New Delhi, India.'}, {'ForeName': 'Aseem', 'Initials': 'A', 'LastName': 'Khurana', 'Affiliation': 'Department of Medical Oncology, Dr BL Kapur Memorial Hospital, New Delhi, India.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Vaibhav', 'Affiliation': 'Dr BL Kapur Memorial Hospital, New Delhi, India.'}, {'ForeName': 'Guresh', 'Initials': 'G', 'LastName': 'Kumar', 'Affiliation': 'Department of Statistics, Institute of Liver and Biliary Sciences, New Delhi, India.'}]",JCO global oncology,['10.1200/GO.20.00269'] 3811,33856733,Inflammatory markers response to crocin supplementation in patients with type 2 diabetes mellitus: A randomized controlled trial.,"Inflammation and oxidative stress is a risk factor for the development of long-term consequences in patients with type 2 diabetes mellitus (T2DM). This study was designed to investigate the effects of crocin consumption on oxidative stress and inflammatory markers in patients with T2DM. In this clinical trial with a parallel-group design, 50 patients with T2DM were randomly assigned to either the crocin or the placebo group. The crocin group received 15 mg crocin twice daily, whereas the placebo group received corresponding placebos. At baseline and the end of week 12, serum high sensitive C-reactive protein (hs-CRP), interleukin-6 (IL-6), tumor necrosis factor-ɑ (TNF-ɑ), nuclear factor-κB (NF-κB), and malondialdehyde (MDA) were measured. Compared with placebo group, crocin reduced hs-CRP (-1.03 vs. 1.42, p = .007), TNF-ɑ (-0.8 vs. 0.28, p = .009), and NF-κB (-0.39 vs. 0.01, p = .047) after 12 weeks intervention; these improvements were also significant in comparison with the baseline values. Plasma IL-6 decreased significantly in the crocin group at the end of week 12 compared to baseline (p = .037), whereas no significant change was observed in the placebo group. Plasma concentration of MDA did not change within and between groups after intervention. This study indicates that daily administration of 30 mg crocin supplement to patients with T2DM reduces the concentrations of hs-CRP, TNF-ɑ, and NF-κB which are involved in the pathogenesis of complications of T2DM.",2021,"Plasma IL-6 decreased significantly in the crocin group at the end of week 12 compared to baseline (p = .037), whereas no significant change was observed in the placebo group.","['patients with type 2 diabetes mellitus', 'patients with T2DM', '50 patients with T2DM', 'patients with type 2 diabetes mellitus (T2DM']","['crocin supplementation', 'crocin consumption', 'placebo', 'placebos']","['Inflammatory markers response', 'Plasma IL-6', 'oxidative stress and inflammatory markers', 'Plasma concentration of MDA', 'NF-κB', 'concentrations of hs-CRP, TNF-ɑ, and NF-κB', 'TNF-ɑ', 'Inflammation and oxidative stress', 'serum high sensitive C-reactive protein (hs-CRP), interleukin-6 (IL-6), tumor necrosis factor-ɑ (TNF-ɑ), nuclear factor-κB (NF-κB), and malondialdehyde (MDA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0056503', 'cui_str': 'crocin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",50.0,0.226014,"Plasma IL-6 decreased significantly in the crocin group at the end of week 12 compared to baseline (p = .037), whereas no significant change was observed in the placebo group.","[{'ForeName': 'Vahideh', 'Initials': 'V', 'LastName': 'Behrouz', 'Affiliation': 'Department of Nutrition, Faculty of Public Health, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Golbon', 'Initials': 'G', 'LastName': 'Sohrab', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hedayati', 'Affiliation': 'Cellular and Molecular Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Meghdad', 'Initials': 'M', 'LastName': 'Sedaghat', 'Affiliation': 'Department of Internal Medicine, Imam-Hossein General Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.7124'] 3812,33856729,"The effects of flaxseed supplementation on metabolic syndrome parameters, insulin resistance and inflammation in ulcerative colitis patients: An open-labeled randomized controlled trial.","The present study aimed to evaluate the efficacy of flaxseed supplementation in the management of metabolic syndrome (MetS)-related parameters among the patients with mild-to-moderate ulcerative colitis (UC). A randomized controlled clinical trial was conducted on 70 patients with UC. Participants were randomized in the intervention group, which received 30 g/day ground flaxseed powder or control group. Anthropometric and biochemical variables were assessed at the beginning and end of 12 weeks of intervention. Of the 70 patients enrolled in this study, 64 subjects were included in the final analysis. From baseline to 12 weeks' intervention, flaxseed supplementation resulted in a significant reduction in the serum concentration of insulin (p < .001), HOMA-IR (p < .001), triglyceride (p = .001), total cholesterol (p < .001), and significant increase in the serum levels of HDL (p = .008). Also, we found a significant improvement in the SCCAI score (p < .001), TNF-α (p = .03), and CRP (p < .001) following the flaxseed supplementation. However, we not observed any significant differences between two groups regarding the body weight, BMI, waist circumferences, systolic, and diastolic blood pressure (p > .05). Overall, 12 weeks of flaxseed supplementation resulted in greater improvement in the some MetS-related parameters.",2021,"From baseline to 12 weeks' intervention, flaxseed supplementation resulted in a significant reduction in the serum concentration of insulin (p < .001), HOMA-IR (p < .001), triglyceride (p = .001), total cholesterol (p < .001), and significant increase in the serum levels of HDL (p = .008).","['ulcerative colitis patients', '70 patients enrolled in this study, 64 subjects were included in the final analysis', 'patients with mild-to-moderate ulcerative colitis (UC', '70 patients with UC']","['flaxseed supplementation', '30\u2009g/day ground flaxseed powder or control group']","['HOMA-IR', 'SCCAI score', 'TNF-α', 'total cholesterol', 'body weight, BMI, waist circumferences, systolic, and diastolic blood pressure', 'metabolic syndrome parameters, insulin resistance and inflammation', 'triglyceride', 'serum levels of HDL', 'CRP', 'serum concentration of insulin']","[{'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0023753', 'cui_str': 'Linum'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]",70.0,0.0915317,"From baseline to 12 weeks' intervention, flaxseed supplementation resulted in a significant reduction in the serum concentration of insulin (p < .001), HOMA-IR (p < .001), triglyceride (p = .001), total cholesterol (p < .001), and significant increase in the serum levels of HDL (p = .008).","[{'ForeName': 'Nava', 'Initials': 'N', 'LastName': 'Morshedzadeh', 'Affiliation': 'Department of Nutrition, Faculty of Public Health, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Rahimlou', 'Affiliation': 'Department of Nutrition, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Shabnam', 'Initials': 'S', 'LastName': 'Shahrokh', 'Affiliation': 'Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Soheila', 'Initials': 'S', 'LastName': 'Karimi', 'Affiliation': 'Nutrition and Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Mirmiran', 'Affiliation': 'Nutrition and Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Zali', 'Affiliation': 'Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.7081'] 3813,33856638,Pembrolizumab plus pomalidomide and dexamethasone for relapsed or refractory multiple myeloma (KEYNOTE-183): subgroup analysis in Japanese patients.,"The global, randomized, open-label KEYNOTE-183 phase 3 study was closed early after an interim analysis showed unfavorable risk-benefit when pembrolizumab was added to pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma (MM). This subgroup analysis reported outcomes in 27 Japanese patients randomly assigned to receive pembrolizumab plus pomalidomide and dexamethasone (n = 15) or pomalidomide and dexamethasone alone (n = 12). Co-primary endpoints were progression-free survival (PFS) and overall survival (OS). After a median (range) follow-up of 9.6 (1.4-15.3) months in Japanese patients, median PFS [6.5 vs 2.8 months; hazard ratio (HR) 0.16 (95% CI 0.03-0.83)] and OS [not reached vs 14.8 months; HR 0.46 (95% CI 0.05-4.20)] seemed to favor the pembrolizumab plus pomalidomide and dexamethasone arm. Objective response rate was numerically higher in this group (47%) than in the pomalidomide and dexamethasone group (25%). The safety profile was consistent with that of the overall study population. No deaths were attributed to a study drug by the investigators. Although adding pembrolizumab to pomalidomide and dexamethasone did not show unfavorable risk-benefit in the Japanese subgroup of KEYNOTE-183, the analysis is limited by short follow-up and small sample size, which affects the generalizability of the results.",2021,Objective response rate was numerically higher in this group (47%) than in the pomalidomide and dexamethasone group (25%).,"['patients with relapsed or refractory multiple myeloma (MM', 'Japanese patients', '27 Japanese patients']","['dexamethasone', 'Pembrolizumab plus pomalidomide and dexamethasone', 'pembrolizumab', 'pomalidomide and dexamethasone', 'pembrolizumab plus pomalidomide and dexamethasone (n\u2009=\u200915) or pomalidomide and dexamethasone alone']","['progression-free survival (PFS) and overall survival (OS', 'unfavorable risk-benefit', 'Objective response rate', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2347624', 'cui_str': 'pomalidomide'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0687742', 'cui_str': 'Risks and Benefits'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",27.0,0.396351,Objective response rate was numerically higher in this group (47%) than in the pomalidomide and dexamethasone group (25%).,"[{'ForeName': 'Morio', 'Initials': 'M', 'LastName': 'Matsumoto', 'Affiliation': 'National Hospital Organization, Shibukawa Medical Center, 383 Shiroi, Shibukawa, 377-0280, Japan. matsumoto.morio.zr@mail.hosp.go.jp.'}, {'ForeName': 'Kenshi', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'Japanese Red Cross Medical Center, Tokyo, Japan.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Kuroda', 'Affiliation': 'Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Taniwaki', 'Affiliation': 'Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Kazutaka', 'Initials': 'K', 'LastName': 'Sunami', 'Affiliation': 'National Hospital Organization Okayama Medical Center, Okayama, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kosugi', 'Affiliation': 'Ogaki Municipal Hospital, Ogaki, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Ando', 'Affiliation': 'Tokai University Hospital, Isehara, Japan.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Maruyama', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Kensei', 'Initials': 'K', 'LastName': 'Tobinai', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Kher', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Farooqui', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Marinello', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Matsuda', 'Affiliation': 'MSD K.K., Tokyo, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Koh', 'Affiliation': 'MSD K.K., Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Shimamoto', 'Affiliation': 'MSD K.K., Tokyo, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Iida', 'Affiliation': 'Nagoya City University Hospital, Nagoya, Japan.'}]",International journal of hematology,['10.1007/s12185-021-03139-1'] 3814,33856613,Placebo controlled phase II clinical trial: Safety and efficacy of combining intranasal insulin & acute exercise.,"A growing number of investigations are exploring the utility of intranasal insulin as a means of mitigating cognitive decline. However, as a basic tenant of dementia prevention programs is increasing physical activity, it is essential to obtain a preliminary assessment of the safety profile of combining intranasal insulin with physical activity; to ensure that undue risks are not incurred. Utilizing a randomized double-blind placebo-controlled design, a sample of 116 non-diabetic, fasted college-aged adults were randomly assigned to receive a dose of 0-to-120 IU of NovoLog (Insulin Aspart) before being randomized to 20 min of exercise or sitting control condition. The safety of intranasal insulin was assessed by examining the incidence of potential symptoms of hypoglycemia and changes in peripheral blood glucose. The efficacy of a combination therapeutic approach was assessed using behavioral measures of inhibition and sustained attention alongside neuroelectric indices of attentional engagement. The frequency of symptoms reported following administration of intranasal insulin were not observed to interact with exercise so as to make their occurrence any more or less prominent, nor was the frequency observed to relate to the dose of intranasal insulin. However, doses of intranasal insulin of 100 IU or more were observed to result in a 7-fold increase in the likelihood of a level 1 hypoglycemic event for those individuals in the exercise condition. This study provides preliminary evidence to suggest that exercise is not associated with an increase in risk when combined with lower doses of intranasal insulin.Clinical trial registration The trial is registered at ClinicalTrials.gov, number NCT04292535.",2021,The efficacy of a combination therapeutic approach was assessed using behavioral measures of inhibition and sustained attention alongside neuroelectric indices of attentional engagement.,"['116 non-diabetic, fasted college-aged adults']","['placebo', 'exercise or sitting control condition', 'intranasal insulin & acute exercise', 'intranasal insulin', 'Placebo', '0-to-120 IU of NovoLog (Insulin Aspart']",['incidence of potential symptoms of hypoglycemia and changes in peripheral blood glucose'],"[{'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0939412', 'cui_str': 'NovoRapid'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",116.0,0.145802,The efficacy of a combination therapeutic approach was assessed using behavioral measures of inhibition and sustained attention alongside neuroelectric indices of attentional engagement.,"[{'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Gwizdala', 'Affiliation': 'Department of Kinesiology, Michigan State University, 126E IM Sports Circle, East Lansing, MI, 48824-1049, USA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Ferguson', 'Affiliation': 'Department of Kinesiology, Michigan State University, 126E IM Sports Circle, East Lansing, MI, 48824-1049, USA.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Kovan', 'Affiliation': 'Department of Intercollegiate Athletics, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Novak', 'Affiliation': 'Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Pontifex', 'Affiliation': 'Department of Kinesiology, Michigan State University, 126E IM Sports Circle, East Lansing, MI, 48824-1049, USA. pontifex@msu.edu.'}]",Metabolic brain disease,['10.1007/s11011-021-00727-2'] 3815,33856589,Human amniotic membrane: an improvement in the treatment of Medication-related osteonecrosis of the jaw (MRONJ)? A case-control study.,"The aim of this article is to report the results obtained by the use of HAM in surgical wound healing and the reduction of relapse in patients affected by Medication-related osteonecrosis of the jaw (MRONJ).The study involved patients with the diagnosis of MRONJ, surgically treated between October 2016 and April 2019, in a case-control setting. Enrolled patients were randomly divided into 2 groups. One group will be treated with resective surgery and with the insertion of HAM patch (Group A), while the second group had been treated exclusively with resective surgery (Group B).The patients underwent MRONJ surgical treatment with the placement of amniotic membrane patches at the wound site. Data regarding the long-term complications/functions were evaluated at 3, 6, 12, and 24 months after surgery. Pain measurements were performed before the intervention (T0), 7(T1) and 30(T2) days after surgery. 49 patients were included in the study. 2 patients of GROUP A after 30 days since they were surgically treated showed persistent bone exposure. 5 patients of group B demonstrated a lack of healing of the surgical wound with the persistence of bone exposed to 30 days after surgery. Statistical analysis ruled out any difference in OUTCOME (relapse) between GROUP A and B (p = 0.23). However, the Fisher test highlighted a significant difference between the use of HAM and only surgical treatment in pain at rest (p = 0.032). The use of amniotic membrane implement the patient's quality of life and reduce pain perception. has a learning curve that is fast enough to justify its routine use.",2021,Statistical analysis ruled out any difference in OUTCOME (relapse) between GROUP A and B (p = 0.23).,"['patients affected by Medication-related osteonecrosis of the jaw (MRONJ).The study involved patients with the diagnosis of MRONJ, surgically treated between October 2016 and April 2019, in a case-control setting', '49 patients were included in the study']","['HAM', 'resective surgery and with the insertion of HAM patch', 'resective surgery (Group B).The patients underwent MRONJ surgical treatment with the placement of amniotic membrane patches at the wound site']","['persistent bone exposure', 'Pain measurements', 'lack of healing of the surgical wound', ""patient's quality of life and reduce pain perception""]","[{'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0029445', 'cui_str': 'Bone necrosis'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0007328', 'cui_str': 'Case Control Studies'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0029445', 'cui_str': 'Bone necrosis'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0002630', 'cui_str': 'Structure of amnion'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0332803', 'cui_str': 'Surgical wound'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",49.0,0.00811706,Statistical analysis ruled out any difference in OUTCOME (relapse) between GROUP A and B (p = 0.23).,"[{'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Ragazzo', 'Affiliation': 'Unit of Oral and Maxillofacial Surgery, Ca Foncello Hospital, 31100, Treviso, Italy. mirkoragazzo@hotmail.com.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Val', 'Affiliation': 'Unit of Oral and Maxillofacial Surgery, Ca Foncello Hospital, 31100, Treviso, Italy. matteo.val@outlook.it.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Montagner', 'Affiliation': ""Treviso Tissue Bank Foundation, Via dell'Ospedale 3, 31100, Treviso, Italy.""}, {'ForeName': 'Diletta', 'Initials': 'D', 'LastName': 'Trojan', 'Affiliation': ""Treviso Tissue Bank Foundation, Via dell'Ospedale 3, 31100, Treviso, Italy.""}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Fusetti', 'Affiliation': 'Department of Neuroscience, University of Padua, Maxillofacial Surgery Unit, Padova, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Guarda Nardini', 'Affiliation': 'Unit of Oral and Maxillofacial Surgery, Ca Foncello Hospital, 31100, Treviso, Italy.'}]",Cell and tissue banking,['10.1007/s10561-021-09922-y'] 3816,33856570,A pilot study comparing daily teriparatide with monthly cycles of teriparatide and raloxifene.,"This 6-month pilot study in osteoporotic postmenopausal women evaluated cyclic TPD/RLX compared to daily subcutaneous TPD with the concept of optimizing bone formation. Compared to daily subcutaneous TPD, cyclic therapy showed comparable increase in spine BMD and favorable effects on total proximal femur BMD and cortical thickness. PURPOSE There is no cure for osteoporosis; better medications or different approaches with current agents are needed. We hypothesized that monthly cycles of teriparatide (TPD) followed by raloxifene (RLX) might promote ongoing bone formation. Additionally, as TPD might initially adversely affect hip BMD, such effects may be mitigated by a cyclic approach. Therefore, this 6-month pilot study evaluated the effect of cyclic TPD/RLX compared to daily subcutaneous TPD on bone markers, BMD, trabecular bone score (TBS), and hip parameters assessed by 3D modeling. METHODS Postmenopausal osteoporotic women (n=26) were randomized to open-label TPD 20 daily or alternating monthly cycles of TPD followed by monthly RLX 60 mg daily. BMD was measured at the lumbar spine (LS), femur, and radius by DXA. To further assess LS BMD, QCT and opportunistic CT (L1 Hounsfield units [HU]) were performed. LS TBS and hip cortical and trabecular parameters were assessed using DXA. Baseline group comparisons were performed by unpaired T-test with change over time evaluated by repeated measures ANOVA. RESULTS Participant mean age, BMI, and lowest T-score were 67.0 years, 26.0 kg/m 2 , and -2.7; no between-group differences in serum chemistries, 25(OH)D, or BMD were observed. LS-BMD increased (p<0.001) with TPD or TPD/RLX as measured by DXA (4.8%/5.2%), QCT (13%/9.4%), or HU (15.6%/10.2%) with no between-group difference. TPD/RLX produced beneficial between-group differences in total proximal femur BMD (1.5%, p<0.05) and cortical thickness (1.6%, p<0.05). CONCLUSION Compared with daily TPD, cyclic TPD/RLX comparably increased spine BMD and might have favorable effects on proximal femur BMD and cortical thickness.",2021,"Compared to daily subcutaneous TPD, cyclic therapy showed comparable increase in spine BMD and favorable effects on total proximal femur BMD and cortical thickness. ","['osteoporotic postmenopausal women evaluated', 'Postmenopausal osteoporotic women (n=26']","['cyclic TPD/RLX', 'daily TPD, cyclic TPD/RLX', 'teriparatide', 'teriparatide and raloxifene', 'TPD/RLX', 'open-label TPD 20 daily or alternating monthly cycles of TPD followed by monthly RLX 60 mg daily', 'raloxifene (RLX', 'teriparatide (TPD']","['LS-BMD', 'QCT', 'BMD', 'spine BMD', 'total proximal femur BMD and cortical thickness', 'total proximal femur BMD', 'cortical thickness', 'bone markers, BMD, trabecular bone score (TBS), and hip parameters assessed by 3D modeling', 'proximal femur BMD and cortical thickness', 'serum chemistries, 25(OH)D, or BMD', 'LS TBS and hip cortical and trabecular parameters']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0244404', 'cui_str': 'Raloxifene'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0412669', 'cui_str': 'Computerized tomography, bone density study'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0181734', 'cui_str': 'Bone marker'}, {'cui': 'C0222660', 'cui_str': 'Trabecular substance of bone'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0007996', 'cui_str': 'Chemistry'}]",,0.0252709,"Compared to daily subcutaneous TPD, cyclic therapy showed comparable increase in spine BMD and favorable effects on total proximal femur BMD and cortical thickness. ","[{'ForeName': 'Heenam', 'Initials': 'H', 'LastName': 'Goel', 'Affiliation': 'Osteoporosis Clinical Research Program, University of Wisconsin-Madison, 2870 University Ave, Suite 100, Madison, WI, 53705, USA.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'Libber', 'Affiliation': 'Osteoporosis Clinical Research Program, University of Wisconsin-Madison, 2870 University Ave, Suite 100, Madison, WI, 53705, USA.'}, {'ForeName': 'Gretta', 'Initials': 'G', 'LastName': 'Borchardt', 'Affiliation': 'Osteoporosis Clinical Research Program, University of Wisconsin-Madison, 2870 University Ave, Suite 100, Madison, WI, 53705, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Krueger', 'Affiliation': 'Osteoporosis Clinical Research Program, University of Wisconsin-Madison, 2870 University Ave, Suite 100, Madison, WI, 53705, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Binkley', 'Affiliation': 'Osteoporosis Clinical Research Program, University of Wisconsin-Madison, 2870 University Ave, Suite 100, Madison, WI, 53705, USA. nbinkley@wisc.edu.'}]",Archives of osteoporosis,['10.1007/s11657-021-00933-6'] 3817,33856549,Topical ketorolac as an adjunctive treatment with intravitreal bevacizumab in the management of diabetic macular edema: A double-masked placebo-controlled randomized clinical trial.,"PURPOSE To evaluate the additional effect of ketorolac eye drops on therapeutic effects of intravitreal Bevacizumab in patients with diabetic macular edema (DME) METHODS: In a randomized clinical trial, 50 patients with center involved DME (macular thickness ≥ 300 microns accompanied by decreased VA (24 < BCVA ≤ 70 ETDRS letters) were enrolled consecutively and randomized 1:1 to receive either bevacizumab plus topical ketorolac (25 patients) or bevacizumab plus artificial tears (25 patients). Patients with proliferative diabetic retinopathy, history of intraocular surgery, intravitreal injection in less than three months, macular photocoagulation less than 6 months and any other concomitant ocular pathologies were excluded from the study. All the patients received three consecutive monthly injections of intravitreal bevacizumab (IVB). After that, patients were examined every 6 weeks and reinjection was administered based on the ""as needed"" protocol if macular thickness was 300 microns or more and VA was 70 ETDRS letters or less.. Patients also received either topical ketorolac or artificial tears three times a day over the study period (6 months). Changes in central subfield thickness (CST), best-corrected visual acuity (BCVA, ETDRS letters), and number of IVB injections were compared between the study groups. RESULTS Fifty eyes of 50 patients were included (25 eyes in each group). Mean CST was significantly decreased in both study groups at 14 th week (-87 ± 98 µm, P = 0.012 and -100 ± 147 µm, P = 0.006 in bevacizumab plus ketorolac and bevacizumab plus artificial tears groups, respectively). Nevertheless, the changes of mean CST remained significant only in bevacizumab plus ketorolac group up to 26 th week (-147 ± 124 µm, P < 0.001 and -51 ± 145 µm, P = 0.245, respectively). Comparing two groups, reduction of mean CST from baseline was significantly greater in bevacizumab plus ketorolac group compared with the control group at 26 th week. (difference = -97 µm, 95%CI = -182 to -11, P = 0.017). In the study group, mean BCVA significantly increased at both 20 th week (6.2 ± 10.1, P = 0.04) and 26 th week (8.2 ± 10.9, P = 0.03). In contrast, visual acuity did not significantly improve at any time points in bevacizumab plus artificial tears group, While insignificant, the 26-week mean change of visual acuity from baseline was greater in bevacizumab plus ketorolac group (difference = 6.5 ETDRS letter; 95%CI = -14.4 to 1.4) Two groups were comparable regarding number of IVB injections (P = 0.99). CONCLUSION Topical ketorolac 0.5% three times a day could enhance and sustain the efficacy of intravitreal bevacizumab in the treatment of DME.",2021,"(difference = -97 µm, 95%CI = -182 to -11, P = 0.017).","['Patients with proliferative diabetic retinopathy, history of intraocular surgery, intravitreal injection in less than three months, macular photocoagulation less than 6\xa0months and any other concomitant ocular pathologies', '50 patients with center involved DME (macular thickness\u2009≥\u2009300 microns accompanied by decreased VA (24\u2009<\u2009BCVA\u2009≤\u200970 ETDRS letters', 'patients with diabetic macular edema (DME', 'diabetic macular edema', 'Fifty eyes of 50 patients were included (25 eyes in each group']","['intravitreal bevacizumab (IVB', 'bevacizumab plus artificial tears', 'bevacizumab plus topical ketorolac', 'Topical ketorolac', 'topical ketorolac', 'bevacizumab plus ketorolac and bevacizumab', 'ketorolac eye drops', 'placebo', 'bevacizumab plus ketorolac', 'intravitreal bevacizumab', 'bevacizumab', 'intravitreal Bevacizumab']","['mean BCVA', 'changes of mean CST', 'visual acuity', 'central subfield thickness (CST), best-corrected visual acuity (BCVA, ETDRS letters), and number of IVB injections', 'number of IVB injections', 'reduction of mean CST', 'Mean CST']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C1522223', 'cui_str': 'Intraocular route'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0023694', 'cui_str': 'Photocoagulation'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0058217', 'cui_str': 'dimethyl ether'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439201', 'cui_str': 'um'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2608262', 'cui_str': 'Artificial Tears'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0560172', 'cui_str': 'cSt'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",50.0,0.140046,"(difference = -97 µm, 95%CI = -182 to -11, P = 0.017).","[{'ForeName': 'Homayoun', 'Initials': 'H', 'LastName': 'Nikkhah', 'Affiliation': 'Ophthalmic Research Center, Research Institute for Ophthalmology and Vision Science, Shahid Beheshti University of Medical Sciences, No.23, Boostan 9 St., Pasdaran Ave., 16666, Tehran, Iran. h.nikkhah52@gmail.com.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Niazpour Moez', 'Affiliation': 'School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Entezari', 'Affiliation': 'Ophthalmic Research Center, Research Institute for Ophthalmology and Vision Science, Shahid Beheshti University of Medical Sciences, No.23, Boostan 9 St., Pasdaran Ave., 16666, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Ramezani', 'Affiliation': 'Department of Ophthalmology, Torfeh Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Kiana', 'Initials': 'K', 'LastName': 'Hassanpour', 'Affiliation': 'Ophthalmic Research Center, Research Institute for Ophthalmology and Vision Science, Shahid Beheshti University of Medical Sciences, No.23, Boostan 9 St., Pasdaran Ave., 16666, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Karimi', 'Affiliation': 'Ophthalmic Research Center, Research Institute for Ophthalmology and Vision Science, Shahid Beheshti University of Medical Sciences, No.23, Boostan 9 St., Pasdaran Ave., 16666, Tehran, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Yaseri', 'Affiliation': 'Department of Epidemiology and Biostatistics, Tehran University of Medical Sciences, Tehran, Iran.'}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-021-05169-1'] 3818,33856434,Assessment of Cumulative Incidence and Severity of Primary Open-Angle Glaucoma Among Participants in the Ocular Hypertension Treatment Study After 20 Years of Follow-up.,"Importance Ocular hypertension is an important risk factor for the development of primary open-angle glaucoma (POAG). Data from long-term follow-up can be used to inform the management of patients with ocular hypertension. Objective To determine the cumulative incidence and severity of POAG after 20 years of follow-up among participants in the Ocular Hypertension Treatment Study. Design, Setting, and Participants Participants in the Ocular Hypertension Treatment Study were followed up from February 1994 to December 2008 in 22 clinics. Data were collected after 20 years of follow-up (from January 2016 to April 2019) or within 2 years of death. Analyses were performed from July 2019 to December 2020. Interventions From February 28, 1994, to June 2, 2002 (phase 1), participants were randomized to receive either topical ocular hypotensive medication (medication group) or close observation (observation group). From June 3, 2002, to December 30, 2008 (phase 2), both randomization groups received medication. Beginning in 2009, treatment was no longer determined by study protocol. From January 7, 2016, to April 15, 2019 (phase 3), participants received ophthalmic examinations and visual function assessments. Main Outcomes and Measures Twenty-year cumulative incidence and severity of POAG in 1 or both eyes after adjustment for exposure time. Results A total of 1636 individuals (mean [SD] age, 55.4 [9.6] years; 931 women [56.9%]; 1138 White participants [69.6%]; 407 Black/African American participants [24.9%]) were randomized in phase 1 of the clinical trial. Of those, 483 participants (29.5%) developed POAG in 1 or both eyes (unadjusted incidence). After adjusting for exposure time, the 20-year cumulative incidence of POAG in 1 or both eyes was 45.6% (95% CI, 42.3%-48.8%) among all participants, 49.3% (95% CI, 44.5%-53.8%) among participants in the observation group, and 41.9% (95% CI, 37.2%-46.3%) among participants in the medication group. The 20-year cumulative incidence of POAG was 55.2% (95% CI, 47.9%-61.5%) among Black/African American participants and 42.7% (95% CI, 38.9%-46.3%) among participants of other races. The 20-year cumulative incidence for visual field loss was 25.2% (95% CI, 22.5%-27.8%). Using a 5-factor baseline model, the cumulative incidence of POAG among participants in the low-, medium-, and high-risk tertiles was 31.7% (95% CI, 26.4%-36.6%), 47.6% (95% CI, 41.6%-53.0%), and 59.8% (95% CI, 53.1%-65.5%), respectively. Conclusions and Relevance In this study, only one-fourth of participants in the Ocular Hypertension Treatment Study developed visual field loss in either eye over long-term follow-up. This information, together with a prediction model, may help clinicians and patients make informed personalized decisions about the management of ocular hypertension. Trial Registration ClinicalTrials.gov Identifier: NCT00000125.",2021,"The 20-year cumulative incidence for visual field loss was 25.2% (95% CI, 22.5%-27.8%).","['patients with ocular hypertension', 'Participants in the Ocular Hypertension Treatment Study', 'after 20 years of follow-up among participants in the Ocular Hypertension Treatment Study', '1636 individuals (mean [SD] age, 55.4 [9.6] years; 931 women [56.9%]; 1138 White participants [69.6%]; 407 Black/African American participants [24.9', 'Participants\n\n\nParticipants in the Ocular Hypertension Treatment Study were followed up from February 1994 to December 2008 in 22 clinics', 'Interventions\n\n\nFrom February 28, 1994, to June 2, 2002']",['topical ocular hypotensive medication (medication group) or close observation (observation group'],"['cumulative incidence of POAG', 'visual field loss', 'Cumulative Incidence and Severity of Primary Open-Angle Glaucoma', 'POAG', 'Measures\n\n\nTwenty-year cumulative incidence and severity of POAG in 1 or both eyes after adjustment for exposure time', 'cumulative incidence and severity of POAG', '20-year cumulative incidence of POAG']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028840', 'cui_str': 'Ocular hypertension'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0581528', 'cui_str': 'Close observation'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C3887875', 'cui_str': 'Visual field defect'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0229118', 'cui_str': 'Structure of both eyes'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",1138.0,0.198619,"The 20-year cumulative incidence for visual field loss was 25.2% (95% CI, 22.5%-27.8%).","[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Kass', 'Affiliation': 'Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Dale K', 'Initials': 'DK', 'LastName': 'Heuer', 'Affiliation': 'David Geffen School of Medicine, Los Angeles, California.'}, {'ForeName': 'Eve J', 'Initials': 'EJ', 'LastName': 'Higginbotham', 'Affiliation': 'Office of Inclusion and Diversity, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Parrish', 'Affiliation': 'Bascom Palmer Eye Institute, Miami, Florida.'}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Khanna', 'Affiliation': 'Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Brandt', 'Affiliation': 'Davis Eye Center, University of California, Davis, Davis.'}, {'ForeName': 'Joern B', 'Initials': 'JB', 'LastName': 'Soltau', 'Affiliation': 'University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Johnson', 'Affiliation': 'University of Iowa, Iowa City.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Keltner', 'Affiliation': 'University of California, Davis, Davis.'}, {'ForeName': 'Julia B', 'Initials': 'JB', 'LastName': 'Huecker', 'Affiliation': 'Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Bradley S', 'Initials': 'BS', 'LastName': 'Wilson', 'Affiliation': 'Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'J Phillip', 'Initials': 'JP', 'LastName': 'Miller', 'Affiliation': 'Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Harry A', 'Initials': 'HA', 'LastName': 'Quigley', 'Affiliation': 'Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Mae O', 'Initials': 'MO', 'LastName': 'Gordon', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2021.0341'] 3819,33856430,Efficacy and Safety of Propranolol vs Atenolol in Infants With Problematic Infantile Hemangiomas: A Randomized Clinical Trial.,"Importance Propranolol has become the first-line therapy for problematic infantile hemangiomas (IHs) that require systemic therapy. However, different adverse events have been reported during propranolol treatment. The positive efficacy and safety of atenolol raise the question of whether it could be used as a promising therapy for IH. Objective To compare the efficacy and safety of propranolol vs atenolol in infants (between age 5 and 20 weeks) with problematic IHs who required systemic therapy. Design, Setting, and Participants This was a prospective, multicenter, randomized, controlled, open-label clinical trial conducted in collaboration among 6 separate investigation sites in China from February 1, 2015, to December 31, 2018. A total of 377 patients met the criteria for inclusion and were randomized to the propranolol (190 [50.4%]) and atenolol (187 [49.6%]) groups. Data were analyzed in June 2020. Interventions Participants were randomized to receive either propranolol or atenolol for at least 6 months. They completed efficacy assessments at 2 years after the initial treatment. Main Outcomes and Measures The primary outcome was any response or nonresponse at 6 months. The key secondary outcome was changes in the hemangioma activity score. Results Of 377 participants, 287 (76.1%) were female, and the mean (SD) age was 10.2 (4.0) weeks in the propranolol group and 9.8 (4.1) weeks in the atenolol group. After 6 months of treatment, in the propranolol and atenolol groups, the overall response rates were 93.7% and 92.5%, respectively (difference, 1.2%; 95% CI, -4.1% to 6.6%). At 1 and 4 weeks after treatment, and thereafter, the hemangioma activity score in the atenolol group aligned with the propranolol group (odds ratio, 1.034; 95% CI, 0.886-1.206). No differences between the propranolol group and atenolol group were observed in successful initial responses, quality of life scores, complete ulceration healing times, or the rebound rate. Both groups presented a similar percentage of complete/nearly complete responses at 2 years (82.1% vs 79.7%; difference, 2.4%; 95% CI, -5.9% to 10.7%). Adverse events were more common in the propranolol group (70.0% vs 44.4%; difference, 25.6%; 95% CI, 15.7%-34.8%), but the frequency of severe adverse events did not differ meaningfully between the groups. Conclusions and Relevance In this randomized clinical trial, when compared with propranolol, atenolol had similar efficacy and fewer adverse events in the treatment of infants with problematic IHs. The results suggest that oral atenolol can be used as an alternative treatment option for patients with IH who require systemic therapy. Trial Registration ClinicalTrial.gov Identifier: NCT02342275.",2021,"No differences between the propranolol group and atenolol group were observed in successful initial responses, quality of life scores, complete ulceration healing times, or the rebound rate.","['collaboration among 6 separate investigation sites in China from February 1, 2015, to December 31, 2018', 'infants with problematic IHs', '377 patients met the criteria for inclusion', 'Infants With Problematic Infantile Hemangiomas', 'infants (between age 5 and 20 weeks) with problematic IHs who required systemic therapy', '377 participants, 287 (76.1%) were female, and the mean (SD) age was 10.2 (4.0) weeks in the propranolol group and 9.8 (4.1) weeks in the atenolol group', 'patients with IH who require systemic therapy']","['atenolol', 'propranolol, atenolol', 'propranolol vs atenolol', 'propranolol', 'Propranolol vs Atenolol', 'propranolol or atenolol', 'propranolol and atenolol', 'Propranolol']","['Efficacy and Safety', 'Adverse events', 'efficacy and safety', 'response or nonresponse at 6 months', 'hemangioma activity score', 'frequency of severe adverse events', 'adverse events', 'successful initial responses, quality of life scores, complete ulceration healing times, or the rebound rate', 'overall response rates']","[{'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0206733', 'cui_str': 'Strawberry nevus of skin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0004147', 'cui_str': 'Atenolol'}]","[{'cui': 'C0004147', 'cui_str': 'Atenolol'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018916', 'cui_str': 'Hemangioma'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.162209,"No differences between the propranolol group and atenolol group were observed in successful initial responses, quality of life scores, complete ulceration healing times, or the rebound rate.","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Ji', 'Affiliation': 'Division of Oncology, Department of Pediatric Surgery, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Siyuan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Pediatric Intensive Care Unit, Department of Critical Care Medicine, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Kaiying', 'Initials': 'K', 'LastName': 'Yang', 'Affiliation': 'Division of Oncology, Department of Pediatric Surgery, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Xuepeng', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Pediatric Intensive Care Unit, Department of Critical Care Medicine, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Jiangyuan', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Division of Oncology, Department of Pediatric Surgery, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Lizhi', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Pediatric Surgery, Fujian Provincial Hospital, Fuzhou, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xiang', 'Affiliation': 'Division of Oncology, Department of Pediatric Surgery, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Qiu', 'Affiliation': 'Division of Oncology, Department of Pediatric Surgery, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Shiyi', 'Initials': 'S', 'LastName': 'Dai', 'Affiliation': 'Division of Oncology, Department of Pediatric Surgery, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Dermatology, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Guoyan', 'Initials': 'G', 'LastName': 'Lu', 'Affiliation': 'Department of Pediatrics, West China Second University Hospital, Sichuan University Chengdu, China.'}, {'ForeName': 'Liqing', 'Initials': 'L', 'LastName': 'Qiu', 'Affiliation': 'Department of Pediatric Surgery, Chengdu Shangjin Nanfu Hospital, Chengdu, China.'}, {'ForeName': 'Feiteng', 'Initials': 'F', 'LastName': 'Kong', 'Affiliation': ""Department of Pediatric Surgery, Sichuan Women and Children's Hospital, Chengdu, China.""}, {'ForeName': 'Yongbo', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Pediatric Surgery, Chengdu Women and Children's Central Hospital, Chengdu, China.""}]",JAMA otolaryngology-- head & neck surgery,['10.1001/jamaoto.2021.0454'] 3820,33856424,"Percutaneous Peripheral Nerve Stimulation (Neuromodulation) for Postoperative Pain: A Randomized, Sham-controlled Pilot Study.","BACKGROUND Percutaneous peripheral nerve stimulation is an analgesic technique involving the percutaneous implantation of a lead followed by the delivery of electric current using an external pulse generator. Percutaneous peripheral nerve stimulation has been used extensively for chronic pain, but only uncontrolled series have been published for acute postoperative pain. The current multicenter study was undertaken to (1) determine the feasibility and optimize the protocol for a subsequent clinical trial and (2) estimate the treatment effect of percutaneous peripheral nerve stimulation on postoperative pain and opioid consumption. METHODS Preoperatively, an electrical lead was percutaneously implanted to target the sciatic nerve for major foot/ankle surgery (e.g., hallux valgus correction), the femoral nerve for anterior cruciate ligament reconstruction, or the brachial plexus for rotator cuff repair, followed by a single injection of long-acting local anesthetic along the same nerve/plexus. Postoperatively, participants were randomized to 14 days of either electrical stimulation (n = 32) or sham stimulation (n = 34) using an external pulse generator in a double-masked fashion. The dual primary treatment effect outcome measures were (1) cumulative opioid consumption (in oral morphine equivalents) and (2) mean values of the ""average"" daily pain scores measured on the 0 to 10 Numeric Rating Scale within the first 7 postoperative days. RESULTS During the first 7 postoperative days, opioid consumption in participants given active stimulation was a median (interquartile range) of 5 mg (0 to 30) versus 48 mg (25 to 90) in patients given sham treatment (ratio of geometric means, 0.20 [97.5% CI, 0.07 to 0.57]; P < 0.001). During this same period, the average pain intensity in patients given active stimulation was a mean ± SD of 1.1 ± 1.1 versus 3.1 ± 1.7 in those given sham (difference, -1.8 [97.5% CI, -2.6 to -0.9]; P < 0.001). CONCLUSIONS Percutaneous peripheral nerve stimulation reduced pain scores and opioid requirements free of systemic side effects during at least the initial week after ambulatory orthopedic surgery. EDITOR’S PERSPECTIVE ",2021,"CONCLUSIONS Percutaneous peripheral nerve stimulation reduced pain scores and opioid requirements free of systemic side effects during at least the initial week after ambulatory orthopedic surgery. ",['Postoperative Pain'],"['Percutaneous Peripheral Nerve Stimulation (Neuromodulation', 'electrical stimulation', 'Percutaneous peripheral nerve stimulation', 'percutaneous peripheral nerve stimulation', 'external pulse generator in a double-masked fashion', 'sham stimulation']","['opioid consumption', 'average pain intensity', 'cumulative opioid consumption (in oral morphine equivalents) and (2) mean values of the ""average"" daily pain scores measured on the 0 to 10 Numeric Rating Scale', 'pain scores']","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0031119', 'cui_str': 'Peripheral nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0394674', 'cui_str': 'Neurostimulation/modulation'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0237638', 'cui_str': 'Generator'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0360457', 'cui_str': 'Morphine-containing product in oral dose form'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.183891,"CONCLUSIONS Percutaneous peripheral nerve stimulation reduced pain scores and opioid requirements free of systemic side effects during at least the initial week after ambulatory orthopedic surgery. ","[{'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Ilfeld', 'Affiliation': ''}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Plunkett', 'Affiliation': ''}, {'ForeName': 'Alice M', 'Initials': 'AM', 'LastName': 'Vijjeswarapu', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hackworth', 'Affiliation': ''}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Dhanjal', 'Affiliation': ''}, {'ForeName': 'Alparslan', 'Initials': 'A', 'LastName': 'Turan', 'Affiliation': ''}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Eisenach', 'Affiliation': ''}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Griffith', 'Affiliation': ''}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Hanling', 'Affiliation': ''}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': ''}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Mascha', 'Affiliation': ''}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Boggs', 'Affiliation': ''}, {'ForeName': 'Amorn', 'Initials': 'A', 'LastName': 'Wongsarnpigoon', 'Affiliation': ''}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Gelfand', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003776'] 3821,33856395,Effect of Intravenous Acetaminophen on Mean Arterial Blood Pressure: A Post Hoc Analysis of the EFfect of Intravenous ACetaminophen on PosToperative HypOxemia After Abdominal SurgeRy Trial.,"BACKGROUND Acetaminophen is commonly used as part of multimodal analgesia for acute pain. The intravenous formulation offers a more predictable bioavailability compared to oral and rectal acetaminophen. There have been reports of hypotension with intravenous acetaminophen attributable to centrally mediated and vasodilatory effects. We tested the hypothesis that in adults having abdominal surgery the use of intravenous acetaminophen versus placebo for postoperative pain management is associated with a decrease in mean arterial pressure (MAP) after its administration. METHODS This is a substudy of eFfect of intravenous ACetaminophen on posToperative hypOxemia after abdominal surgeRy (FACTOR) trial (NCT02156154). FACTOR trial randomly assigned adults undergoing abdominal surgery to either 1 g of acetaminophen or placebo every 6 hours during the first postoperative 48 hours. Continuous monitoring of blood pressure was obtained by noninvasive ViSi Mobile device (Sotera Wireless, Inc, San Diego, CA) at 15-second intervals during initial 48 hours postoperatively. We excluded patients without continuous monitoring data available. The primary outcome was the MAP difference between MAP 5 minutes before study drug administration (baseline) and MAP 30 minutes poststudy drug administration initiation. We used a linear mixed effects model to assess the treatment effect on MAP change. The secondary outcome was MAP area under baseline (AUB) during the 30 minutes after treatment. In a sensitivity analysis of change in MAP from predrug to postdrug administration, we instead used postdrug MAP as the outcome adjusting for the baseline MAP in the model. RESULTS Among 358 patients analyzed, 182 received acetaminophen and 176 placebo. The mean (standard deviation [SD]) of average MAP change was -0.75 (5.9) mm Hg for the treatment and 0.32 (6.3) mm Hg for the placebo. Acetaminophen was found to decrease the MAP from baseline more than placebo after drug administration. The estimated difference in mean change of MAP was -1.03 (95% confidence interval [CI] -1.60 to -0.47) mm Hg; P < .001. The sensitivity analysis showed postoperative MAP in the acetaminophen group was 1.33 (95% CI, 0.76-1.90) mm Hg lower than in the placebo group (P < .001). The median of MAP AUB was 33 [Q1 = 3.3, Q3 = 109] mm Hg × minutes for the treatment and 23 [1.6, 79] mm Hg × minutes for the placebo. Acetaminophen was found to increase the AUB with an estimated median difference of 15 (95% CI, 5-25) mm Hg × minutes (P = .003). CONCLUSIONS Intravenous acetaminophen decreases MAP after its administration. However, this decrease does not appear to be clinically meaningful. Clinicians should not refrain to use intravenous acetaminophen for acute pain management because of worries of hypotension.",2021,Hg lower than in the placebo group (P < .001).,"['adults undergoing abdominal surgery to either 1 g of', 'after abdominal surgeRy', 'adults having abdominal surgery', '358 patients analyzed, 182 received']","['rectal acetaminophen', 'acetaminophen or placebo', 'Intravenous Acetaminophen', 'acetaminophen and 176 placebo', 'acetaminophen versus placebo', 'placebo', 'Acetaminophen', 'acetaminophen', 'ACetaminophen']","['MAP', 'Mean Arterial Blood Pressure', 'mean change of MAP', 'blood pressure', 'average MAP change', 'PosToperative HypOxemia', 'median of MAP AUB', 'posToperative hypOxemia', 'MAP difference between MAP 5 minutes before study drug administration (baseline) and MAP 30 minutes poststudy drug administration initiation', 'MAP area under baseline (AUB', 'AUB', 'MAP change', 'mean arterial pressure (MAP', 'predictable bioavailability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}]",,0.735151,Hg lower than in the placebo group (P < .001).,"[{'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Bravo', 'Affiliation': 'From the Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Bakal', 'Affiliation': 'From the Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Rivas', 'Affiliation': 'From the Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Mascha', 'Affiliation': 'From the Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Pu', 'Affiliation': 'From the Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Lauretta', 'Initials': 'L', 'LastName': 'Mosteller', 'Affiliation': 'From the Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Rodriguez-Patarroyo', 'Affiliation': 'From the Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Essber', 'Affiliation': 'From the Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'AlGharrash', 'Affiliation': 'From the Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Alparslan', 'Initials': 'A', 'LastName': 'Turan', 'Affiliation': 'From the Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005429'] 3822,33856385,Randomized Controlled Trial Comparing the Short-term Outcomes of Enhanced Recovery After Surgery and Conventional Care in Laparoscopic Distal Gastrectomy (GISSG1901).,"OBJECTIVE This study aimed to compare the effects of ERAS and conventional programs on short-term outcomes after laparoscopic distal gastrectomy (LDG). SUMMARY BACKGROUND DATA Currently, the enhanced recovery after surgery (ERAS) program is broadly applied in surgical areas. Although several benefits of LDG with the ERAS program have been covered, high-level evidence is still limited, specifically in advanced gastric cancer (AGC). METHODS The present study was designed as a randomized, multicenter, unblinded trial. The enrollment criteria included histologically confirmed cT2-4aN0-3M0 gastric adenocarcinoma. Postoperative complications, mortality, readmission, medical costs, recovery and laboratory outcomes were compared between the ERAS and conventional groups. RESULTS Between April 2019 and May 2020, 400 consecutive patients who met the enrollment criteria were enrolled. They were randomly allocated to either the ERAS group (n = 200) or the conventional group (n = 200). After excluding patients who did not undergo surgery or gastrectomy, 370 patients were analyzed. The patient demographic characteristics were not different between the two groups. The conventional group had a significantly longer allowed day of discharge and postoperative hospital stay (6.96 vs 5.83 days, P<0.001; 8.85 vs 7.27 days, P<0.001); a longer time to first flatus, liquid intake and ambulation (3.37 vs 2.52 days, P<0.001; 3.09 vs 1.13 days, P<0.001; 2.85 vs 1.38 days, P<0.001, respectively); and higher medical costs (6826 vs 6328 $, P = 0.027) than the ERAS group. Additionally, patients in the ERAS group were more likely to initiate adjuvant chemotherapy earlier (29 vs 32 days, P = 0.035). There was no significant difference in postoperative complications or in the mortality or readmission rates. Regarding laboratory outcomes, the procalcitonin and C-reactive protein levels on postoperative day (POD) 3 were significantly lower and the hemoglobin levels on POD5 were significantly higher in the ERAS group than in the conventional group. CONCLUSION The ERAS program provides a faster recovery, a shorter postoperative hospitalization length, and lower medical costs after LDG without increasing complication and readmission rates. Moreover, enhanced recovery in the ERAS group enables early initiation of adjuvant chemotherapy.",2021,There was no significant difference in postoperative complications or in the mortality or readmission rates.,"['Between April 2019 and May 2020, 400 consecutive patients who met the enrollment criteria were enrolled', 'After excluding patients who did not undergo surgery or gastrectomy, 370 patients were analyzed']","['Laparoscopic Distal Gastrectomy (GISSG1901', 'ERAS and conventional programs', 'laparoscopic distal gastrectomy (LDG', 'ERAS', 'Enhanced Recovery']","['procalcitonin and C-reactive protein levels on postoperative day (POD', 'higher medical costs', 'Postoperative complications, mortality, readmission, medical costs, recovery and laboratory outcomes', 'day of discharge and postoperative hospital stay', 'longer time to first flatus, liquid intake and ambulation', 'postoperative complications', 'hemoglobin levels on POD5', 'mortality or readmission rates', 'likely to initiate adjuvant chemotherapy earlier', 'postoperative hospitalization length, and lower medical costs']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C4517743', 'cui_str': '370'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0192440', 'cui_str': 'Distal subtotal gastrectomy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",370.0,0.0655418,There was no significant difference in postoperative complications or in the mortality or readmission rates.,"[{'ForeName': 'Yulong', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': ""Affiliated Hospital of Qingdao University, Department of Gastrointestinal Surgery, China Shandong Provincial Hospital, Department of Gastrointestinal Surgery, China Qilu Hospital of Shandong University, Department of Gastrointestinal Surgery, China Yantai Yuhuangding Hospital, Department of Gastrointestinal Surgery, China Weihai Central Hospital, Department of Gastrointestinal Surgery, China Jining People's Hospital, Department of Gastrointestinal Surgery, China Dongying People's Hospital, Department of Gastrointestinal Surgery, China Qianfoshan Hospital of Shandong Province, Department of Gastrointestinal Surgery, China Second Hospital of Shandong University, Department of Gastrointestinal Surgery, China Qingdao Municipal Hospital, Department of Gastrointestinal Surgery, China Rizhao People's Hospital, Department of Gastrointestinal Surgery, China Weifang People's Hospital, Department of Oncological Surgery, China Weihai Municipal Hospital, Department of Gastrointestinal Surgery, China Section of Surgical Pathophysiology 7621, Rigshospitalet Copenhagen University, Denmark.""}, {'ForeName': 'Shougen', 'Initials': 'S', 'LastName': 'Cao', 'Affiliation': ''}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Leping', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Qingsi', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Lixin', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': ''}, {'ForeName': 'Xinjian', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Xianqun', 'Initials': 'X', 'LastName': 'Chu', 'Affiliation': ''}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Lijian', 'Initials': 'L', 'LastName': 'Xia', 'Affiliation': ''}, {'ForeName': 'Yinlu', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': ''}, {'ForeName': 'Weizheng', 'Initials': 'W', 'LastName': 'Mao', 'Affiliation': ''}, {'ForeName': 'Xizeng', 'Initials': 'X', 'LastName': 'Hui', 'Affiliation': ''}, {'ForeName': 'Yiran', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': ''}, {'ForeName': 'Huanhu', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Zhaojian', 'Initials': 'Z', 'LastName': 'Niu', 'Affiliation': ''}, {'ForeName': 'Zequn', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Haitao', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': ''}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Kehlet', 'Affiliation': ''}, {'ForeName': 'Yanbing', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004908'] 3823,33856360,Development and Implementation of a Mobile Tool for High-Risk Pregnant Women to Deliver Effective Caregiving for Neonatal Abstinence Syndrome: Protocol for a Mixed Methods Study.,"BACKGROUND The United States continues to experience an alarming rise in opioid use that includes women who become pregnant and related neonatal abstinence syndrome (NAS) in newborns. Most newborns experiencing NAS require nonpharmacological care, which entails, most importantly, maternal involvement with the newborn. To facilitate positive maternal-newborn interactions, mothers need to learn effective caregiving NAS strategies when they are pregnant; however, an enormous gap exists in the early education of mothers on the symptoms and progression of NAS, partly because no education, training, or other interventions exist to prepare future mothers for the challenges of caring for their newborns at risk for NAS. OBJECTIVE In this paper, we describe a mixed methods, multistage study to adapt an existing mobile NAS tool for high-risk pregnant women and assess its usability, acceptability, and feasibility in a small randomized controlled trial. METHODS Stage 1 will include 20 semistructured interviews with a panel of neonatology experts, NAS care providers, and mothers with experience caring for NAS-affected newborns to gather their recommendations on the management of NAS and explore their perspectives on the care of these newborns. The findings will guide the adaptation of existing mobile NAS tools for high-risk pregnant women. In stage 2, we will test the usability, acceptability, and feasibility of the adapted mobile tool via surveys with 10 pregnant women receiving opioid agonist therapy (OAT). Finally, in stage 3, we will randomize 30 high-risk pregnant women receiving OAT to either receive the adapted mobile NAS caregiving tool or usual care. We will compare these women on primary outcomes-maternal drug relapse and OAT continuation-and secondary outcomes-maternal-newborn bonding; length of newborn hospital stays; readmission rates; breastfeeding initiation and duration; and postpartum depression and anxiety at 4, 8, and 12 weeks postpartum. RESULTS This project was funded in July 2020 and approved by the institutional review board in April 2020. Data collection for stage 1 began in December 2020, and as of January 2021, we completed 18 semistructured interviews (10 with NAS providers and 8 with perinatal women receiving OAT). Common themes from all interviews will be analyzed in spring 2021 to inform the adaptation of the NAS caregiving tool. The results from stage 1 are expected to be published in summer 2021. Stage 2 data collection will commence in fall 2021. CONCLUSIONS The findings of this study have the potential to improve NAS care and maternal-newborn outcomes and lead to commercialized product development. If effective, our new tool will be well suited to tailoring for other high-risk perinatal women with substance use disorders. TRIAL REGISTRATION ClinicalTrials.gov NCT04783558; https://clinicaltrials.gov/ct2/show/NCT04783558. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/27382.",2021,"If effective, our new tool will be well suited to tailoring for other high-risk perinatal women with substance use disorders. ","['women who become pregnant and related neonatal abstinence syndrome (NAS) in newborns', '30 high-risk pregnant women receiving', 'stage 1 began in December 2020, and as of January 2021, we completed 18 semistructured interviews (10 with NAS providers and 8 with perinatal women receiving OAT', 'High-Risk Pregnant Women to Deliver Effective Caregiving for Neonatal Abstinence Syndrome', 'high-risk pregnant women', '10 pregnant women receiving', 'Stage 1 will include 20 semistructured interviews with a panel of neonatology experts, NAS care providers, and mothers with experience caring for NAS-affected newborns to gather their recommendations on the management of NAS and explore their perspectives on the care of these newborns']","['opioid agonist therapy (OAT', 'OAT to either receive the adapted mobile NAS caregiving tool or usual care']",['maternal drug relapse and OAT continuation-and secondary outcomes-maternal-newborn bonding; length of newborn hospital stays; readmission rates; breastfeeding initiation and duration; and postpartum depression and anxiety'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0027609', 'cui_str': 'Neonatal Abstinence Syndrome'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0027621', 'cui_str': 'Neonatology'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0039828', 'cui_str': 'Theses'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027609', 'cui_str': 'Neonatal Abstinence Syndrome'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",10.0,0.146027,"If effective, our new tool will be well suited to tailoring for other high-risk perinatal women with substance use disorders. ","[{'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Burduli', 'Affiliation': 'College of Nursing, Washington State University, Spokane, WA, United States.'}, {'ForeName': 'Hendrée E', 'Initials': 'HE', 'LastName': 'Jones', 'Affiliation': 'UNC Horizons, Department of Obstetrics and Gynecology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Brooks', 'Affiliation': 'College of Nursing, Washington State University, Spokane, WA, United States.'}, {'ForeName': 'Celestina', 'Initials': 'C', 'LastName': 'Barbosa-Leiker', 'Affiliation': 'College of Nursing, Washington State University, Spokane, WA, United States.'}, {'ForeName': 'Ron Kim', 'Initials': 'RK', 'LastName': 'Johnson', 'Affiliation': 'Managed Health Connections, LLC, Spokane, WA, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Roll', 'Affiliation': 'Elson S. Floyd College of Medicine, Washington State University, Spokane, WA, United States.'}, {'ForeName': 'Sterling Marshall', 'Initials': 'SM', 'LastName': 'McPherson', 'Affiliation': 'Analytics and PsychoPharmacology Laboratory, Washington State University, Spokane, WA, United States.'}]",JMIR research protocols,['10.2196/27382'] 3824,33856355,Effect of a Virtual Reality-Enhanced Exercise and Education Intervention on Patient Engagement and Learning in Cardiac Rehabilitation: Randomized Controlled Trial.,"BACKGROUND Cardiac rehabilitation (CR) is clinically proven to reduce morbidity and mortality; however, many eligible patients do not enroll in treatment. Furthermore, many enrolled patients do not complete their full course of treatment. This is greatly influenced by socioeconomic factors but is also because of patients' lack of understanding of the importance of their care and a lack of motivation to maintain attendance. OBJECTIVE This study aims to explore the potential benefits of virtual reality (VR) walking trails within CR treatment, specifically with regard to patient knowledge retention, satisfaction with treatment, and the overall attendance of treatment sessions. METHODS New CR patients were enrolled and randomized on a rolling basis to either the control group or intervention group. Intervention patients completed their time on the treadmill with VR walking trails, which included audio-recorded education, whereas control patients completed the standard of care therapy. Both groups were assisted by nursing staff for all treatment sessions. Primary outcomes were determined by assessing 6-minute walk test improvement. In addition, secondary outcomes of patients' cardiac knowledge and satisfaction were assessed via a computer-based questionnaire; patient adherence to the recommended number of sessions was also monitored. Cardiac knowledge assessment included a prerehabilitation education quiz, and the same quiz was repeated at patients' final visit and again at the 2-month follow-up. The satisfaction questionnaire was completed at the final visit. RESULTS Between January 2018 and May 2019, 72 patients were enrolled-41 in the intervention group and 31 in the control group. On the basis of the results of the prerehabilitation and postrehabilitation 6-minute walk test, no significant differences were observed between the intervention and control groups (P=.64). No statistical differences were observed between groups in terms of education (P=.86) or satisfaction (P=.32) at any time point. The control group had statistically more favorable rates of attendance, as determined by the risk group comparison (P=.02) and the comparison of the rates for completing the minimum number of sessions (P=.046), but no correlation was observed between the study group and reasons for ending treatment. CONCLUSIONS Although no improvements were seen in the VR intervention group over the control group, it is worth noting that limitations in the study design may have influenced these outcomes, not the medium itself. Furthermore, the qualitative information suggests that patients may have indeed enjoyed their experience with VR, even though quantitative satisfaction data did not capture this. Further considerations for how and when VR should be applied to CR are suggested in this paper. TRIAL REGISTRATION ClinicalTrials.gov NCT03945201; https://clinicaltrials.gov/ct2/show/NCT03945201.",2021,"The control group had statistically more favorable rates of attendance, as determined by the risk group comparison (P=.02) and the comparison of the rates for completing the minimum number of sessions (P=.046), but no correlation was observed between the study group and reasons for ending treatment. ","['Patient Engagement and Learning in Cardiac Rehabilitation', 'Between January 2018 and May 2019, 72 patients were enrolled-41 in the intervention group and 31 in the control group', 'New CR patients']","['Virtual Reality-Enhanced Exercise and Education Intervention', 'control group or intervention group', 'Cardiac rehabilitation (CR', 'virtual reality (VR) walking trails', 'treadmill with VR walking trails, which included audio-recorded education, whereas control patients completed the standard of care therapy']","['satisfaction questionnaire', '6-minute walk test improvement', ""patients' cardiac knowledge and satisfaction"", 'favorable rates of attendance', 'morbidity and mortality']","[{'cui': 'C3508152', 'cui_str': 'Patient Engagement'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",72.0,0.0272681,"The control group had statistically more favorable rates of attendance, as determined by the risk group comparison (P=.02) and the comparison of the rates for completing the minimum number of sessions (P=.046), but no correlation was observed between the study group and reasons for ending treatment. ","[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Gulick', 'Affiliation': 'Information Services & Technologies, Jefferson Health, Philadelphia, PA, United States.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Graves', 'Affiliation': 'Rehabilitation Medicine, Thomas Jefferson University, Philadelphia, PA, United States.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Ames', 'Affiliation': 'Rehabilitation Medicine, Thomas Jefferson University, Philadelphia, PA, United States.'}, {'ForeName': 'Pavitra Parimala', 'Initials': 'PP', 'LastName': 'Krishnamani', 'Affiliation': 'Department of Emergency Medicine, Baylor College of Medicine, Houston, TX, United States.'}]",Journal of medical Internet research,['10.2196/23882'] 3825,33856337,Intensive Cryotherapy in the Emergency Department (ICED): A Randomized Controlled Trial.,"INTRODUCTION Pain control is an essential component of musculoskeletal injury treatment in the emergency department (ED). We evaluated the most effective type of cryotherapy for analgesia of acute musculoskeletal injury and the impact on opioid utilization. METHODS This was a prospective, randomized, single-blind controlled trial of adult ED patients who presented with acute musculoskeletal pain. Patients were randomized to either intensive targeted cryotherapy (crushed wetted ice in a plastic bag) or agitated chemical cold pack applied to the injury site for 20 minutes. All other diagnostic and therapeutic orders were at the discretion of the treating physician. Visual analog pain scores were measured at the time of cryotherapy application, at 20 minutes (time of cryotherapy removal), and at 60 minutes (40 minutes after removal). RESULTS We enrolled 38 patients, 17 randomized to intensive targeted cryotherapy and 21 to chemical cold packs, with well-matched demographics. The intensive targeted cryotherapy group achieved significantly greater pain relief at 20 minutes (2.1 [95% confidence interval (CI), 1.3 - 2.9] vs 0.9 [95% CI, 0.3 - 1.5], P < 0.05) and at 60 minutes (2.7 [95% CI, 1.6 - 3.7] vs 1.2 [95% CI, 0.6 - 1.7], P < 0.05), number need to trial (NNT) = 3.2. Opioid administration in the ED was significantly lower in the intensive targeted cryotherapy group (1 [6%] vs 7 [33%], P < 0.05), NNT = 3.6. Those who received a discharge opiate prescription had significantly higher 60-minute pain scores (7.3 ± 2.2 vs 4.1 ± 2.7, P < 0.05). CONCLUSION Intensive targeted cryotherapy provided more effective analgesia than chemical cold packs for acute musculoskeletal injuries in the ED and may contribute to lower opioid usage.",2021,"The intensive targeted cryotherapy group achieved significantly greater pain relief at 20 minutes (2.1 [95% confidence interval (CI), 1.3 - 2.9] vs 0.9 [95% CI, 0.3 - 1.5], P < 0.05) and at 60 minutes (2.7 [95% CI, 1.6 - 3.7] vs 1.2 [95% CI, 0.6 - 1.7], P < 0.05), number need to trial (NNT) = 3.2.","['38 patients, 17 randomized to', 'in the Emergency Department (ICED', 'adult ED patients who presented with acute musculoskeletal pain']","['chemical cold packs', 'intensive targeted cryotherapy and 21 to chemical cold packs, with well-matched demographics', 'Intensive Cryotherapy', 'intensive targeted cryotherapy (crushed wetted ice in a plastic bag) or agitated chemical cold pack applied to the injury site for 20 minutes', 'cryotherapy']","['60-minute pain scores', 'pain relief', 'Visual analog pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0020746', 'cui_str': 'Ice'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}]","[{'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0180006', 'cui_str': 'Cold pack'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0185060', 'cui_str': 'Crushing'}, {'cui': 'C0020746', 'cui_str': 'Ice'}, {'cui': 'C0032167', 'cui_str': 'Plastic'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]",38.0,0.147144,"The intensive targeted cryotherapy group achieved significantly greater pain relief at 20 minutes (2.1 [95% confidence interval (CI), 1.3 - 2.9] vs 0.9 [95% CI, 0.3 - 1.5], P < 0.05) and at 60 minutes (2.7 [95% CI, 1.6 - 3.7] vs 1.2 [95% CI, 0.6 - 1.7], P < 0.05), number need to trial (NNT) = 3.2.","[{'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Leroux', 'Affiliation': 'Eisenhower Health, Department of Emergency Medicine, Rancho Mirage, California.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Kaufman', 'Affiliation': 'Scripps Health, Department of Emergency Medicine, San Diego, California.'}, {'ForeName': 'Christian N', 'Initials': 'CN', 'LastName': 'Kontaxis', 'Affiliation': 'Stanford University, Department of Undergraduate Studies, Stanford, California.'}, {'ForeName': 'Grant S', 'Initials': 'GS', 'LastName': 'Lipman', 'Affiliation': 'Stanford University School of Medicine, Department of Emergency Medicine, Stanford, California.'}]",The western journal of emergency medicine,['10.5811/westjem.2020.10.48831'] 3826,33856325,Randomized Controlled Trial of Ultrasound-guided Fluid Resuscitation of Sepsis-Induced Hypoperfusion and Septic Shock.,"INTRODUCTION The ultrasound measurement of inferior vena cava (IVC) diameter change during respiratory phase to guide fluid resuscitation in shock patients is widely performed, but the benefit on reducing the mortality of sepsis patients is questionable. The study objective was to evaluate the 30-day mortality rate of patients with sepsis-induced tissue hypoperfusion (SITH) and septic shock (SS) treated with ultrasound-guided fluid management (UGFM) using ultrasonographic change of the IVC diameter during respiration compared with those treated with the usual-care strategy. METHODS This was a randomized controlled trial conducted in an urban, university-affiliated tertiary-care hospital. Adult patients with SITH/SS were randomized to receive treatment with UGFM using respiratory change of the IVC (UGFM strategy) or with the usual-care strategy during the first six hours after emergency department (ED) arrival. We compared the 30-day mortality rate and other clinical outcomes between the two groups. RESULTS A total of 202 patients were enrolled, 101 in each group (UGFM vs usual-care strategy) for intention-to-treat analysis. There was no significant difference in 30-day overall mortality between the two groups (18.8% and 19.8% in the usual-care and UGFM strategy, respectively; p > 0.05 by log rank test). Neither was there a difference in six-hour lactate clearance, a change in the sequential organ failure assessment score, or length of hospital stay. However, the cumulative fluid amount given in 24 hours was significantly lower in the UGFM arm. CONCLUSION In our ED setting, the use of respiratory change of IVC diameter determined by point-of-care ultrasound to guide initial fluid resuscitation in SITH/SS ED patients did not improve the 30-day survival probability or other clinical parameters compared to the usual-care strategy. However, the IVC ultrasound-guided resuscitation was associated with less amount of fluid used.",2021,"Neither was there a difference in six-hour lactate clearance, a change in the sequential organ failure assessment score, or length of hospital stay.","['shock patients', '202 patients were enrolled, 101 in each group (UGFM vs usual-care strategy) for intention-to-treat analysis', 'Adult patients with SITH/SS', 'urban, university-affiliated tertiary-care hospital', 'patients with sepsis-induced tissue hypoperfusion (SITH) and septic shock (SS) treated with']","['Ultrasound-guided Fluid Resuscitation', 'ultrasound-guided fluid management (UGFM', 'UGFM']","['sequential organ failure assessment score, or length of hospital stay', '30-day overall mortality', '30-day mortality rate', 'six-hour lactate clearance', '30-day survival probability']","[{'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0553741', 'cui_str': 'Fluid balance regulation'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0442856', 'cui_str': 'Hypoperfusion'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0553741', 'cui_str': 'Fluid balance regulation'}]","[{'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",202.0,0.0646838,"Neither was there a difference in six-hour lactate clearance, a change in the sequential organ failure assessment score, or length of hospital stay.","[{'ForeName': 'Khrongwong', 'Initials': 'K', 'LastName': 'Musikatavorn', 'Affiliation': 'Chulalongkorn University and King Chulalongkorn Memorial Hospital, The Thai Red Cross Society, Department of Emergency Medicine, Faculty of Medicine, Bangkok, Thailand.'}, {'ForeName': 'Poj', 'Initials': 'P', 'LastName': 'Plitawanon', 'Affiliation': 'Chulalongkorn University and King Chulalongkorn Memorial Hospital, The Thai Red Cross Society, Department of Emergency Medicine, Faculty of Medicine, Bangkok, Thailand.'}, {'ForeName': 'Suthaporn', 'Initials': 'S', 'LastName': 'Lumlertgul', 'Affiliation': 'Chulalongkorn University and King Chulalongkorn Memorial Hospital, The Thai Red Cross Society, Department of Emergency Medicine, Faculty of Medicine, Bangkok, Thailand.'}, {'ForeName': 'Khuansiri', 'Initials': 'K', 'LastName': 'Narajeenron', 'Affiliation': 'Chulalongkorn University and King Chulalongkorn Memorial Hospital, The Thai Red Cross Society, Department of Emergency Medicine, Faculty of Medicine, Bangkok, Thailand.'}, {'ForeName': 'Dhanadol', 'Initials': 'D', 'LastName': 'Rojanasarntikul', 'Affiliation': 'Chulalongkorn University and King Chulalongkorn Memorial Hospital, The Thai Red Cross Society, Department of Emergency Medicine, Faculty of Medicine, Bangkok, Thailand.'}, {'ForeName': 'Tanawat', 'Initials': 'T', 'LastName': 'Tarapan', 'Affiliation': 'Chulalongkorn University and King Chulalongkorn Memorial Hospital, The Thai Red Cross Society, Department of Emergency Medicine, Faculty of Medicine, Bangkok, Thailand.'}, {'ForeName': 'Jutamas', 'Initials': 'J', 'LastName': 'Saoraya', 'Affiliation': 'Chulalongkorn University and King Chulalongkorn Memorial Hospital, The Thai Red Cross Society, Department of Emergency Medicine, Faculty of Medicine, Bangkok, Thailand.'}]",The western journal of emergency medicine,['10.5811/westjem.2020.11.48571'] 3827,33856279,Supported Web-Based Acceptance and Commitment Therapy for Older Family Caregivers (CareACT) Compared to Usual Care.,"Objectives : The objective of the present study was to investigate whether an acceptance and commitment therapy (ACT)-based web-intervention (Group 1, CareACT), or a standardized rehabilitation in a rehabilitation center (Group 2) was effective in enhancing the psychological well-being of family caregivers aged 60 and over compared to support provided by voluntary caregiver associations (Group 3). Methods: Altogether, 149 family caregivers participated in this quasi-experimental study. Primary outcome measure was depression. Secondary outcomes included anxiety, sense of coherence, quality of life, psychological flexibility, experiential avoidance, and thought suppression. The questionnaires were administered at baseline, and four, and 10 months post-measurement. We investigated differences in the changes between the groups using Mplus modeling techniques. Results: Regarding the main outcome of depression, the results suggest that the CareACT intervention was superior to standardized rehabilitation and to the support given by caregiver associations at four months, both showing a medium-sized difference between the groups. However, the change from four to 10 months post-intervention was not significantly different between these groups (d = 0.32-0.36). Thought suppression showed a significantly different change between the three groups from baseline to four months and to 10 months post-measurement ( p = .038). Conclusions: Web-based ACT may have beneficial effects on depressive symptoms and thought suppression in older caregivers. Clinical implications : Web-based ACT could be a feasible alternative to institutional rehabilitation and support provided by voluntary caregiver associations. Web-based ACT respond s flexibly to the needs of caregivers and provides them an opportunity for learning new skills to promote well-being.",2021,Thought suppression showed a significantly different change between the three groups from baseline to four months and to 10 months post-measurement ( p = .038).,"['older caregivers', 'Older Family Caregivers (CareACT', '149 family caregivers participated in this quasi-experimental study']","['acceptance and commitment therapy (ACT)-based web-intervention (Group 1, CareACT), or a standardized rehabilitation in a rehabilitation center', 'CareACT intervention']","['depression', 'anxiety, sense of coherence, quality of life, psychological flexibility, experiential avoidance, and thought suppression']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3178983', 'cui_str': 'Salutogenesis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",149.0,0.0919714,Thought suppression showed a significantly different change between the three groups from baseline to four months and to 10 months post-measurement ( p = .038).,"[{'ForeName': 'Päivi', 'Initials': 'P', 'LastName': 'Lappalainen', 'Affiliation': 'The Gerocenter Foundation for Research and Development, Jyväskylä, Finland.'}, {'ForeName': 'Inka', 'Initials': 'I', 'LastName': 'Pakkala', 'Affiliation': 'The Gerocenter Foundation for Research and Development, Jyväskylä, Finland.'}, {'ForeName': 'Raimo', 'Initials': 'R', 'LastName': 'Lappalainen', 'Affiliation': 'Department of Psychology, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Riku', 'Initials': 'R', 'LastName': 'Nikander', 'Affiliation': 'The Gerocenter Foundation for Research and Development, Jyväskylä, Finland.'}]",Clinical gerontologist,['10.1080/07317115.2021.1912239'] 3828,33856157,"Effect of transfemoral prosthetic socket interface design on gait, balance, mobility, and preference: A randomized clinical trial.","BACKGROUND There are alternative transfemoral (TF) socket interface designs that have not been compared with the standard of care, ischial ramus containment (IRC). The interface directly affects performance. OBJECTIVES To compare 3 TF interface designs, IRC, dynamic socket (DS), and subischial (Sub-I), regarding gait, balance, mobility, and preference. The authors hypothesized that these more active users may experience gait, mobility, and preference benefits from the less intrusive DS and Sub-I interface designs. STUDY DESIGN Single-blind, repeated-measures, 3-period randomized controlled crossover clinical trial. METHODS People with unilateral TF amputation with 1 year or longer prosthesis use experience, independent community ambulatory status, 18 to 60 years of age, of any race or ethnicity, with a body mass of 45 to 125 kg, and with a self-reported ability to walk for 20 minutes continuously were included in the study. Each participant was fit in all 3 interface designs. RESULTS Thirteen participants completed the clinical trial. Velocity, cadence, mobility, and balance were not statistically different between the 3 socket conditions. The DS demonstrated significantly greater symmetry in swing, stance, single support percentage, and toe angle compared with IRC and Sub-I. Sixty days after study completion, 7 participants changed interfaces, trending away from IRC. CONCLUSIONS Large differences were not observed. Small differences in spatiotemporal gait measures combined with patient preference may make a meaningful difference to individual patients and should be considered.",2021,"The DS demonstrated significantly greater symmetry in swing, stance, single support percentage, and toe angle compared with IRC and Sub-I. Sixty days after study completion, 7 participants changed interfaces, trending away from IRC. ","['People with unilateral TF amputation with 1 year or longer prosthesis use experience, independent community ambulatory status, 18 to 60 years of age, of any race or ethnicity, with a body mass of 45 to 125 kg, and with a self-reported ability to walk for 20 minutes continuously were included in the study', 'Thirteen participants completed the clinical trial']",['transfemoral prosthetic socket interface design'],"['Velocity, cadence, mobility, and balance', 'gait, balance, mobility, and preference', 'symmetry in swing, stance, single support percentage, and toe angle', '3 TF interface designs, IRC, dynamic socket (DS), and subischial (Sub-I), regarding gait, balance, mobility, and preference']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0002691', 'cui_str': 'Amputation above-knee'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0449874', 'cui_str': 'Use of prosthesis'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040357', 'cui_str': 'Toe structure'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0223654', 'cui_str': 'Structure of superior ischial ramus'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}]",13.0,0.225149,"The DS demonstrated significantly greater symmetry in swing, stance, single support percentage, and toe angle compared with IRC and Sub-I. Sixty days after study completion, 7 participants changed interfaces, trending away from IRC. ","[{'ForeName': 'Jason T', 'Initials': 'JT', 'LastName': 'Kahle', 'Affiliation': 'Prosthetic Design & Research, Tampa, FL OP Solutions, Tampa, FL School of Physical Therapy & Rehabilitation Sciences, Morsani College of Medicine, University of South Florida, Tampa, FL Mechanical Engineering Department, College of Engineering, University of South Florida, Tampa, FL Department of Bioengineering and Software Engineering, U.A. Whitaker College of Engineering, Florida Gulf Coast University, Fort Myers, FL US Department of Veterans Affairs, Extremity Trauma & Amputation Center of Excellence, Tampa, FL US Army Reserves, 319 Minimal Care Detachment, Pinellas Park, FL.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Miro', 'Affiliation': ''}, {'ForeName': 'Loi T', 'Initials': 'LT', 'LastName': 'Ho', 'Affiliation': ''}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Porter', 'Affiliation': ''}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Lura', 'Affiliation': ''}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Carey', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lunseth', 'Affiliation': ''}, {'ForeName': 'Ann E', 'Initials': 'AE', 'LastName': 'Swanson', 'Affiliation': ''}, {'ForeName': 'M Jason', 'Initials': 'MJ', 'LastName': 'Highsmith', 'Affiliation': ''}]",Prosthetics and orthotics international,['10.1097/PXR.0000000000000013'] 3829,33856155,Functional performance differences between carbon fiber and fiberglass prosthetic feet.,"BACKGROUND Persons with lower limb amputation require increased functionality. The largest category of feet for active individuals with a transtibial amputation is energy storage and return (ESR) feet. These feet are typically constructed of carbon fiber composite materials. Recently, a prosthetic foot composed of a fiberglass composite has emerged in the market. However, there are no comparative studies of these devices. OBJECTIVES Compare the biomechanical performance and prosthesis-related quality of life when using a fiberglass prosthetic foot design compared with traditional carbon fiber ESR designs. STUDY DESIGN This is a repeated-measures randomized cross-over trial. METHODS Gait analysis was performed on 10 experienced male subjects with unilateral transtibial amputations (K-level III) while walking on level ground and a ramp. Patient-reported outcomes were collected using the Prosthesis Evaluation Questionnaire. RESULTS Gait data demonstrated increased ankle dorsiflexion (P < .01), similar ankle moments (P = .07), and increased ankle power generation (P = .01) when using the fiberglass foot. The increased power generation occurred at the correct time in the gait cycle such that the timing and magnitude of peak knee flexion was unaffected (P > .19). The fiberglass foot had greater energy absorption during gait (P = .01) with no difference in energy return (P = .37). The subjects expressed improved prosthesis-related quality of life with the fiberglass foot (P = .01). CONCLUSIONS The findings of this study demonstrate that the new ESR foot comprising a fiberglass material had better performance than traditional designs using a carbon fiber material.",2021,The fiberglass foot had greater energy absorption during gait (P = .01) with no difference in energy return (P = .37).,"['Persons with lower limb amputation', '10 experienced male subjects with unilateral transtibial amputations (K-level III) while walking on level ground and a ramp']",['carbon fiber and fiberglass prosthetic feet'],"['biomechanical performance and prosthesis-related quality of life', 'energy absorption', 'similar ankle moments', 'ankle dorsiflexion', 'peak knee flexion', 'prosthesis-related quality of life', 'ankle power generation', 'energy return', 'power generation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0337308', 'cui_str': 'Amputation of lower limb'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0441927', 'cui_str': 'Level III'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0034646', 'cui_str': 'Ramp'}]","[{'cui': 'C0108411', 'cui_str': 'Carbon fiber'}, {'cui': 'C0060317', 'cui_str': 'Fiberglass'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}]","[{'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0332156', 'cui_str': 'Return to'}]",10.0,0.02427,The fiberglass foot had greater energy absorption during gait (P = .01) with no difference in energy return (P = .37).,"[{'ForeName': 'Kenton R', 'Initials': 'KR', 'LastName': 'Kaufman', 'Affiliation': 'Motion Analysis Laboratory, Department of Orthopedic Surgery, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Kathie', 'Initials': 'K', 'LastName': 'Bernhardt', 'Affiliation': ''}]",Prosthetics and orthotics international,['10.1097/PXR.0000000000000004'] 3830,33856045,Varying reactions to feedback and their effects on observer accuracy and feedback omission.,"The effectiveness of performance feedback depends on many factors, including accuracy and repeated delivery over time. Previous research has suggested that requiring the delivery of performance feedback may result in less accurate observations and feedback during subsequent observations. The current study evaluated whether different reactions (i.e., positive, neutral, or negative) to feedback would affect the accuracy of subsequent observations or the delivery of feedback. Forty-five participants were assigned to 1 of 3 reactions groups and they were instructed to observe and record the safety performance of a confederate during a baseline condition. Following 2 baseline sessions, participants were instructed to deliver feedback and the confederate reacted to the feedback according to the assigned condition for 4 sessions. Results provide evidence that positive reactions maintain observation accuracy and the provision of feedback, while both neutral and negative reactions decrease observation accuracy and result in frequent omission of feedback.",2021,"Results provide evidence that positive reactions maintain observation accuracy and the provision of feedback, while both neutral and negative reactions decrease observation accuracy and result in frequent omission of feedback.",['Forty-five participants'],[],['observer accuracy and feedback omission'],"[{'cui': 'C4319567', 'cui_str': '45'}]",[],"[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",45.0,0.0329573,"Results provide evidence that positive reactions maintain observation accuracy and the provision of feedback, while both neutral and negative reactions decrease observation accuracy and result in frequent omission of feedback.","[{'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Matey', 'Affiliation': 'Department of Psychology, University of Florida.'}, {'ForeName': 'Andressa', 'Initials': 'A', 'LastName': 'Sleiman', 'Affiliation': 'Department of Psychology, University of Florida.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Nastasi', 'Affiliation': 'Department of Psychology, University of Florida.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Richard', 'Affiliation': 'School of Leadership and Human Resources Development, Louisiana State University.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Gravina', 'Affiliation': 'Department of Psychology, University of Florida.'}]",Journal of applied behavior analysis,['10.1002/jaba.840'] 3831,33855996,Effect of Foot Reflexology and Aromatherapy on Anxiety and Pain During Brachytherapy for Cervical Cancer.,"OBJECTIVES To determine if the addition of aromatherapy and foot reflexology to the standard of care improves pain and anxiety in patients receiving brachytherapy for cervical cancer. SAMPLE & SETTING 41 women with locally advanced cervical cancer who received intracavitary brachytherapy as part of their treatment. METHODS & VARIABLES Participants were randomized to either the control group, which received the standard-of-care management during brachytherapy, or the intervention group, which received the addition of aromatherapy and foot reflexology to standard of care. Participants rated their pain on a numeric rating scale and anxiety on the State-Trait Anxiety Inventory (STAI) and a numeric rating scale at five different time points. RESULTS All average pain and anxiety scores were equal or lower at each key time point for the intervention group. Statistically significant differences were found for the intervention group for anxiety on the numeric rating scale and on the STAI, but only post-reflexology. IMPLICATIONS FOR NURSING Nurses and other healthcare providers can be trained to provide reflexology during painful, anxiety-producing procedures to increase patient tolerance of these treatments and overall quality of life.",2021,"Statistically significant differences were found for the intervention group for anxiety on the numeric rating scale and on the STAI, but only post-reflexology. ","['patients receiving brachytherapy for cervical cancer', '41 women with locally advanced cervical cancer who received intracavitary brachytherapy as part of their treatment', 'Cervical Cancer', 'AMP']","['standard-of-care management during brachytherapy, or the intervention group, which received the addition of aromatherapy and foot reflexology to standard of care', 'Foot Reflexology and Aromatherapy', 'aromatherapy and foot reflexology']","['numeric rating scale', 'pain on a numeric rating scale and anxiety on the State-Trait Anxiety Inventory (STAI) and a numeric rating scale', 'pain and anxiety', 'All average pain and anxiety scores', 'Anxiety and Pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006098', 'cui_str': 'Brachytherapy'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0021864', 'cui_str': 'Intracavitary brachytherapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001465', 'cui_str': 'Adenosine phosphate'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0006098', 'cui_str': 'Brachytherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0034945', 'cui_str': 'Reflexology'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",41.0,0.0262508,"Statistically significant differences were found for the intervention group for anxiety on the numeric rating scale and on the STAI, but only post-reflexology. ","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Blackburn', 'Affiliation': 'Arthur G. James Cancer Hospital and Richard J. Solove Research Institute.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hill', 'Affiliation': 'Arthur G. James Cancer Hospital and Richard J. Solove Research Institute.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Lindsey', 'Affiliation': 'Arthur G. James Cancer Hospital and Richard J. Solove Research Institute.'}, {'ForeName': 'Loraine T', 'Initials': 'LT', 'LastName': 'Sinnott', 'Affiliation': 'Ohio State University.'}, {'ForeName': 'Kathrynn', 'Initials': 'K', 'LastName': 'Thompson', 'Affiliation': ''}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Quick', 'Affiliation': 'Ohio State University Wexner Medical Center.'}]",Oncology nursing forum,['10.1188/21.ONF.265-276'] 3832,33855995,Effects of a Web-Based Pediatric Oncology Legacy Intervention on Parental Coping.,"OBJECTIVES To examine the effects of a legacy intervention for children with advanced cancer and their parents on parental coping strategies. SAMPLE & SETTING The authors recruited 150 children with advanced cancer and their parents via Facebook. METHODS & VARIABLES Child-parent dyads were randomly assigned to the intervention or usual care. Children in the intervention group created electronic digital storyboards to assist in documenting their legacies. Parents completed the Responses to Stress Questionnaire at baseline/preintervention (T1) and postintervention (T2). Linear regressions were used to test for differences between the groups in the amount of change from T1 to T2 for each parent coping score. RESULTS Although not statistically significant, the legacy intervention showed trends toward increasing use of primary control and disengagement coping strategies in parents over time relative to usual care. IMPLICATIONS FOR NURSING Nurses can help to facilitate opportunities for parents to use adaptive coping strategies. More work is needed to determine how legacy interventions in pediatric oncology can facilitate adaptive coping strategies for parents of children with cancer.",2021,"Although not statistically significant, the legacy intervention showed trends toward increasing use of primary control and disengagement coping strategies in parents over time relative to usual care. ","['150 children with advanced cancer and their parents via Facebook', 'parents of children with cancer', 'Child-parent dyads', 'children with advanced cancer and their parents on parental coping strategies']","['Web-Based Pediatric Oncology Legacy Intervention', 'legacy intervention', 'electronic digital storyboards', 'intervention or usual care', 'SAMPLE &']",[],"[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1518931', 'cui_str': 'Pediatric oncology'}, {'cui': 'C0242538', 'cui_str': 'Inheritance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001465', 'cui_str': 'Adenosine phosphate'}]",[],150.0,0.0103401,"Although not statistically significant, the legacy intervention showed trends toward increasing use of primary control and disengagement coping strategies in parents over time relative to usual care. ","[{'ForeName': 'Terrah', 'Initials': 'T', 'LastName': 'Foster Akard', 'Affiliation': 'Vanderbilt University.'}, {'ForeName': 'Mary S', 'Initials': 'MS', 'LastName': 'Dietrich', 'Affiliation': 'Vanderbilt University.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Friedman', 'Affiliation': 'Vanderbilt University Medical Center.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Wray', 'Affiliation': 'Vanderbilt University.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Gerhardt', 'Affiliation': ""Nationwide Children's Hospital.""}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Given', 'Affiliation': 'Michigan State University.'}, {'ForeName': 'Verna L', 'Initials': 'VL', 'LastName': 'Hendricks-Ferguson', 'Affiliation': 'Saint Louis University.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Hinds', 'Affiliation': 'George Washington University.'}, {'ForeName': 'Eunji', 'Initials': 'E', 'LastName': 'Cho', 'Affiliation': 'Vanderbilt University.'}, {'ForeName': 'Mary Jo', 'Initials': 'MJ', 'LastName': 'Gilmer', 'Affiliation': 'Vanderbilt University.'}]",Oncology nursing forum,['10.1188/21.ONF.309-316'] 3833,33855988,Effectiveness of Expressive Writing protocol in Palliative Care Healthworkers: a quantitative study.,"BACKGROUND AND AIM OF THE WORK Palliative Care professionals are exposed to intense emotional environment. This puts them at risk for Compassion Fatigue and Burnout. The protective factors that can counter their onset are Compassion Satisfaction, Organizational Commitment and Resilience. Expressive Writing is a valid tool for adapting to traumatic events and enhancing psychological well-being. Aim of this study is to evaluate the effect of the Expressive Writing in Palliative Care professionals on Compassion Satisfaction, Organizational Commitment, Resilience, Compassion Fatigue and perceived distress. METHODS Prospective experimental study with experimental/control groups and pre/post measurements. 50 Palliative Care professionals were recruited in Northern and Central Italy. Participants filled: Organizational Commitment Questionnaire; ProQol - revision III; Resilience Scale for Adults; Impact of Event-Scale Revised; Emotion Thermometer; ad hoc questionnaire for the evaluation of protocol usefulness. RESULTS Wilcoxon test demonstrated change in Continuative Commitment (Z = -3.357, p = .001), anger (Z = -2.214, p = .027), sleep (Z = -2.268, p = .023), help (Z = -2.184, p = .029), intrusiveness (Z = -2.469, p = .014), hyperarousal (Z = -2.717, p = .007), and total IES (Z = -2.456 , p =, 014). Mann Whitney test showed a significantly lower score on post-test Intrusiveness in the experimental group (U = 202, p = .038). CONCLUSIONS The Expressive Writing intervention was effective in improving organizational and emotional variables. Expressive Writing supports healthcare professionals in relieving the burden of traumatic episodes, ordering associated thoughts and emotions, and implementing a process of deep comprehension.",2021,"RESULTS Wilcoxon test demonstrated change in Continuative Commitment (Z = -3.357, p = .001), anger (Z = -2.214, p = .027), sleep (Z = -2.268, p = .023), help (Z = -2.184, p = .029), intrusiveness (Z = -2.469, p = .014), hyperarousal (Z = -2.717, p = .007), and total IES","['50 Palliative Care professionals were recruited in Northern and Central Italy', 'Palliative Care Healthworkers']","['Expressive Writing', 'Expressive Writing protocol', 'Expressive Writing intervention']","['hyperarousal', 'sleep', 'Compassion Satisfaction, Organizational Commitment, Resilience, Compassion Fatigue and perceived distress', 'total IES', 'Continuative Commitment', 'organizational and emotional variables']","[{'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022277', 'cui_str': 'Italy'}]","[{'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4552570', 'cui_str': 'Hyperarousal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0029246', 'cui_str': 'Organizations'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C4042834', 'cui_str': 'Vicarious Traumatization'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",,0.154541,"RESULTS Wilcoxon test demonstrated change in Continuative Commitment (Z = -3.357, p = .001), anger (Z = -2.214, p = .027), sleep (Z = -2.268, p = .023), help (Z = -2.184, p = .029), intrusiveness (Z = -2.469, p = .014), hyperarousal (Z = -2.717, p = .007), and total IES","[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cosentino', 'Affiliation': 'University of Parma. chiara.cosentino1@unipr.it.'}, {'ForeName': 'Clelia', 'Initials': 'C', 'LastName': ""D'apice"", 'Affiliation': 'Department of medicine and Surgery, University of Parma, Italy . clelia.dapice@unipr.it.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Del Gaudio', 'Affiliation': 'Hospital Ramazzini of Carpi, Ausl of Modena, Italy. maria.delgaudio95@gmail.com.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Bertoletti', 'Affiliation': 'Post Graduate Specialization in Palliative Care, University of Parma, Italy. c.bertoletti18@yahoo.it.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Bini', 'Affiliation': 'Post Graduate Specialization in Palliative Care, University of Parma, Italy. manub72@hotmail.it.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Liotti', 'Affiliation': 'Post Graduate Specialization in Palliative Care, University of Parma, Italy. mariacristinalio651@gmail.com.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Melli', 'Affiliation': 'Post Graduate Specialization in Palliative Care, University of Parma, Italy. ellypanter79@gmail.com.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Tesa', 'Affiliation': 'Post Graduate Specialization in Palliative Care, University of Parma, Italy. francescatesa24@gmail.com.'}, {'ForeName': 'Leopoldo', 'Initials': 'L', 'LastName': 'Sarli', 'Affiliation': 'Department of medicine and Surgery, University of Parma, Italy . leopoldo.sarli@unipr.it.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Artioli', 'Affiliation': 'Azienda USL-IRCCS of Reggio Emilia, Italy. giovanna.artioli@unipr.it.'}]",Acta bio-medica : Atenei Parmensis,['10.23750/abm.v92iS2.11468'] 3834,33855908,Ultrasound-guided versus uterine sound-sparing approach during copper intrauterine device insertion: a randomised clinical trial.,"OBJECTIVE To compare the outcomes of trans-abdominal ultrasound (TAS) guided approach and uterine sound-sparing approach (USSA) during copper intrauterine device (IUD) insertion. STUDY DESIGN A randomised open-label clinical trial (Clinical Trials.Gov: NCT03383432) included multiparous women requesting Copper IUD insertion for birth control were invited to participate. The eligible women were randomised into two groups (44 women in each group); group I (TAS-guided IUD insertion) and group II: USSA. The primary outcome was to measure the satisfaction score of IUD insertion in both methods. Secondary outcomes included the easiness score (ES), the difference in pain scores during IUD insertion, the duration of insertion, and the successful device placement after one week and one month evaluated by transvaginal ultrasound (TVS). RESULTS Eighty-eight women were analysed in both groups. The VAS for satisfaction was significantly higher in the USSA group than the TAS-guided group (7.80 ± 1.27 vs. 5.45 ± 1.42, p  = .0001). There was significantly lower VAS of pain scores during IUD insertion in the USSA group as compared with the TAS-guided IUD ( p  = .001). A lower ES and a significantly shorter duration of IUD insertion were also determined among the USSA group ( p  = .0001). CONCLUSIONS USSA is associated with higher satisfaction and less pain during insertion than the TAS-guided IUD insertion approach. However, both techniques have optimal intra-uterine device positioning.",2021,There was significantly lower VAS of pain scores during IUD insertion in the USSA group as compared with the TAS-guided IUD ( p  = .001).,"['multiparous women requesting Copper IUD insertion for birth control were invited to participate', 'Eighty-eight women']","['group I (TAS-guided IUD insertion) and group II: USSA', 'Ultrasound-guided versus uterine sound-sparing approach during copper intrauterine device insertion', 'USSA', 'trans-abdominal ultrasound (TAS) guided approach and uterine sound-sparing approach (USSA']","['satisfaction score of IUD insertion', 'easiness score (ES), the difference in pain scores during IUD insertion, the duration of insertion, and the successful device placement after one week and one month evaluated by transvaginal ultrasound (TVS', 'VAS of pain scores', 'duration of IUD insertion', 'VAS for satisfaction']","[{'cui': 'C0026751', 'cui_str': 'Multiparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0021901', 'cui_str': 'Copper Intrauterine Devices'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C4517898', 'cui_str': '88'}]","[{'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0175729', 'cui_str': 'Uterine sound'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0021901', 'cui_str': 'Copper Intrauterine Devices'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0203418', 'cui_str': 'Transvaginal echography'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",88.0,0.353644,There was significantly lower VAS of pain scores during IUD insertion in the USSA group as compared with the TAS-guided IUD ( p  = .001).,"[{'ForeName': 'Mohammed K', 'Initials': 'MK', 'LastName': 'Ali', 'Affiliation': 'Department of Obstetrics & Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Asmaa K', 'Initials': 'AK', 'LastName': 'Ramadan', 'Affiliation': 'Department of Obstetrics & Gynecology, Assiut General Hospital, Assiut, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Abu-Elhassan', 'Affiliation': 'Department of Obstetrics & Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Ahmed M A', 'Initials': 'AMA', 'LastName': 'Sobh', 'Affiliation': 'Department of Obstetrics & Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}]",The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception,['10.1080/13625187.2021.1900565'] 3835,33855883,Experiences of Military Veterans in a Therapeutic Horseback Riding Program.,"Posttraumatic stress disorder commonly occurs among U.S. military veterans. Therapeutic horseback riding (THR) has emerged as an adjunct therapy. We explored 20 veterans' perceived benefits, drawbacks and views of a 6-week THR program. Participants had confirmed diagnoses of posttraumatic stress disorder, traumatic brain injury, or both. Veterans rode the same horse weekly, the same day, at the same time. Data were collected as part of a randomized clinical trial testing the effects of THR on Post-Traumatic Stress Disorder. Veterans responded to an open-ended questionnaire. Content analysis was used for data analysis. Benefits were ""Connection to the Horse,"" ""Relaxing,"" ""180 Degree Change,"" and ""Meeting New People."" Drawbacks were ""None,"" ""Struggle to Get There,"" ""Pain,"" ""Too Short,"" and ""It is Structured."" Overall perceptions were ""I Absolutely Loved It,"" ""Feel Again,"" ""The Horse,"" ""The People,"" and ""No Worries."" Participants viewed THR as positive. Findings may elucidate why THR may be clinically beneficial.",2021,"Overall perceptions were ""I Absolutely Loved It,"" ""Feel Again,"" ""The Horse,"" ""The People,"" and ""No Worries.""","['20 veterans', 'Participants had confirmed diagnoses of posttraumatic stress disorder, traumatic brain injury, or both', 'U.S. military veterans', 'Experiences of Military Veterans in a Therapeutic Horseback Riding Program']","['THR', 'Therapeutic horseback riding (THR']",[],"[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0073361', 'cui_str': 'RID'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0336962', 'cui_str': 'Horseback riding'}]",[],,0.0949587,"Overall perceptions were ""I Absolutely Loved It,"" ""Feel Again,"" ""The Horse,"" ""The People,"" and ""No Worries.""","[{'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Johnson', 'Affiliation': 'University of Missouri, Columbia, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Albright', 'Affiliation': 'The University of Alabama, Tuscaloosa, USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Marzolf', 'Affiliation': 'Whole Health Institute, Bentonville, AR.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Bibbo', 'Affiliation': 'Benjamin Rose Institute on Aging, Cleveland, OH, USA.'}, {'ForeName': 'Hayley D', 'Initials': 'HD', 'LastName': 'Yaglom', 'Affiliation': 'University of Missouri, Columbia, USA.'}, {'ForeName': 'Sandra M', 'Initials': 'SM', 'LastName': 'Crowder', 'Affiliation': 'Missouri Department of Vocational Rehabilitation, Jefferson City, MO.'}, {'ForeName': 'Gretchen M', 'Initials': 'GM', 'LastName': 'Carlisle', 'Affiliation': 'University of Missouri, Columbia, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Grindler', 'Affiliation': 'Cedar Creek Therapeutic Riding Center, Columbia, MO, USA.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Harms', 'Affiliation': 'TREE House of Greater St. Louis, Wentzville, MO, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Willard', 'Affiliation': 'TREE House of Greater St. Louis, Wentzville, MO, USA.'}, {'ForeName': 'Marita', 'Initials': 'M', 'LastName': 'Wassman', 'Affiliation': 'Ride On St. Louis, Kimmswick, MO, USA.'}, {'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Russell', 'Affiliation': 'University of Missouri-Kansas City, USA.'}]",Clinical nursing research,['10.1177/10547738211003580'] 3836,33855879,Effectiveness of Tendon and Nerve Gliding Exercises in the Treatment of Patients With Mild Idiopathic Carpal Tunnel Syndrome: A Randomized Controlled Trial.,"BACKGROUND There is limited evidence regarding the efficacy of different treatment options in patients with carpal tunnel syndrome (CTS). This study aimed at assessing the effectiveness of nerve and tendon gliding exercises in the treatment of patients with mild CTS. METHODS The current prospective, randomized trial with pretest-posttest design was conducted on 80 patients with mild CTS randomly assigned to 2 groups. The treatment group was instructed to perform gliding exercises in addition to the wrist splint use. The control group only used the wrist splint. All the patients were instructed to use the splint at night and during the day if required. Patients were evaluated in terms of clinical parameters (ie, grip and pinch strength). The severity of symptoms and functional status was also determined using the Boston Carpal Tunnel Syndrome Questionnaire. The subjects were followed up for 6 weeks. RESULTS There were no significant differences in all parameters between groups. The pretest-posttest analysis showed a statistically significant improvement in subjective and objective parameters in the treatment group. However, in the control group, only a significant improvement was observed in grip strength. Wrist splint use led to a significant change in the severity of symptoms only over the second week. CONCLUSIONS Both gliding exercise and wrist splint groups showed some improvement in the severity of symptoms and functional status scores. However, the gliding exercises did not offer additional benefit compared with wrist splint alone.",2021,There were no significant differences in all parameters between groups.,"['Patients With Mild Idiopathic Carpal Tunnel Syndrome', 'patients with mild CTS', '80 patients with mild CTS randomly assigned to 2 groups', 'patients with carpal tunnel syndrome (CTS']","['nerve and tendon gliding exercises', 'Wrist splint', 'wrist splint', 'gliding exercises in addition to the wrist splint use', 'gliding exercise and wrist splint', 'Tendon and Nerve Gliding Exercises']","['severity of symptoms and functional status scores', 'subjective and objective parameters', 'severity of symptoms', 'grip strength', 'severity of symptoms and functional status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0336966', 'cui_str': 'Gliding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}]",80.0,0.016192,There were no significant differences in all parameters between groups.,"[{'ForeName': 'Hossein Ali', 'Initials': 'HA', 'LastName': 'Abdolrazaghi', 'Affiliation': 'Department of Hand and Reconstructive Surgery, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Khansari', 'Affiliation': 'Department of Hand and Reconstructive Surgery, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Mirshahi', 'Affiliation': 'Department of Hand and Reconstructive Surgery, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahin', 'Initials': 'M', 'LastName': 'Ahmadi Pishkuhi', 'Affiliation': 'Pars Advanced and Minimally Invasive Medical Manners Research Center, Pars Hospital, Iran University of Medical Sciences, Tehran, Iran.'}]","Hand (New York, N.Y.)",['10.1177/15589447211006857'] 3837,33855868,Health-related quality of life and pain with selinexor in patients with advanced dedifferentiated liposarcoma.,"Objective: Compare health-related quality of life (HRQoL) of selinexor versus placebo in patients with dedifferentiated liposarcoma. Materials & methods: HRQoL was assessed at baseline and day 1 of each cycle using the European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire. Results were reported from baseline to day 169 (where exposure to treatment was maximized while maintaining adequate sample size). Results: Pain scores worsened for placebo versus selinexor across all postbaseline visits, although differences in HRQoL at some visits were not significant. Other domains did not exhibit significant differences between arms; however, scores in both arms deteriorated over time. Conclusion: Patients treated with selinexor reported lower rates and slower worsening of pain compared with patients who received placebo.",2021,"Pain scores worsened for placebo versus selinexor across all postbaseline visits, although differences in HRQoL at some visits were not significant.","['patients with dedifferentiated liposarcoma', 'patients with advanced dedifferentiated liposarcoma']","['selinexor versus placebo', 'placebo']","['Pain scores', 'Health-related quality of life and pain with selinexor', 'health-related quality of life (HRQoL', 'Cancer 30-item core\xa0quality of life questionnaire', 'lower rates and slower worsening of pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023827', 'cui_str': 'Liposarcoma'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C3852671', 'cui_str': 'Selinexor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3852671', 'cui_str': 'Selinexor'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439834', 'cui_str': 'Slow'}]",,0.283781,"Pain scores worsened for placebo versus selinexor across all postbaseline visits, although differences in HRQoL at some visits were not significant.","[{'ForeName': 'Mrinal', 'Initials': 'M', 'LastName': 'Gounder', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, NY\xa010021, USA.'}, {'ForeName': 'Albiruni R', 'Initials': 'AR', 'LastName': 'Abdul Razak', 'Affiliation': 'Toronto Sarcoma Program, Princess Margaret Cancer Centre, Toronto, ON, M5G 2C1, Canada.'}, {'ForeName': 'Adrienne M', 'Initials': 'AM', 'LastName': 'Gilligan', 'Affiliation': 'Karyopharm Therapeutics, Newton, MA\xa002459, USA.'}, {'ForeName': 'Hoyee', 'Initials': 'H', 'LastName': 'Leong', 'Affiliation': 'Karyopharm Therapeutics, Newton, MA\xa002459, USA.'}, {'ForeName': 'Xiwen', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Karyopharm Therapeutics, Newton, MA\xa002459, USA.'}, {'ForeName': 'Neeta', 'Initials': 'N', 'LastName': 'Somaiah', 'Affiliation': 'Department of Sarcoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX\xa077030, USA.'}, {'ForeName': 'Sant P', 'Initials': 'SP', 'LastName': 'Chawla', 'Affiliation': 'Sarcoma Oncology Center, Santa Monica, CA\xa090403, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Martin-Broto', 'Affiliation': 'Institute of Biomedicine Research (IBIS)/CSIC/Universidad de Sevilla, Virgen del Rocio University Hospital, Calle Antonio Maura Montaner, 41013, Sevilla, Spain.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Grignani', 'Affiliation': 'Division of Medical Oncology, Candiolo Cancer Institute, FPO-IRCCS, 10060, Candiolo (TO), Italy.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Schuetze', 'Affiliation': 'Division of Hematology/Oncology, University of Michigan, Ann Arbor, MI\xa048109, USA.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vincenzi', 'Affiliation': 'Policlinico Universitario Campus, Bio-Medico, Via Álvaro del Portillo, 200, 00128, Roma, Italy.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Wagner', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA\xa002215, USA.'}, {'ForeName': 'Bartosz', 'Initials': 'B', 'LastName': 'Chmielowski', 'Affiliation': 'Division of Hematology-Oncology, Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, CA 90024, USA.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Jones', 'Affiliation': 'The Royal Marsden NHS Foundation Trust & The Institute of Cancer Research, London, SM2 5PT, UK.'}, {'ForeName': 'Jatin', 'Initials': 'J', 'LastName': 'Shah', 'Affiliation': 'Karyopharm Therapeutics, Newton, MA\xa002459, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Shacham', 'Affiliation': 'Karyopharm Therapeutics, Newton, MA\xa002459, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kauffman', 'Affiliation': 'Karyopharm Therapeutics, Newton, MA\xa002459, USA.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Riedel', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, NC\xa027710, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Attia', 'Affiliation': 'Department of Internal Medicine, Division of Hematology/Oncology, Mayo Clinic, Jacksonville, FL\xa032224, USA.'}]","Future oncology (London, England)",['10.2217/fon-2021-0284'] 3838,33855861,Cost-effectiveness of Hypertension Treatment by Pharmacists in Black Barbershops.,"Background: In the Los Angeles Barbershop Blood Pressure Study (LABBPS), pharmacist-led hypertension care in Los Angeles County Black-owned barbershops significantly improved blood pressure control in non-Hispanic Black men with uncontrolled hypertension at baseline. In this analysis, 10-year health outcomes and healthcare costs of one year of the LABBPS intervention versus control are projected. Methods: A discrete event simulation of hypertension care processes projected blood pressure, medication-related adverse events, fatal and non-fatal cardiovascular disease events, and non-cardiovascular disease death in LABBPS participants. Program costs, total direct healthcare costs (2019 USD), and quality-adjusted life years (QALYs) were estimated for the LABBPS intervention and control arms from a healthcare sector perspective over a 10-year horizon. Future costs and QALYs were discounted 3% annually. High and intermediate cost-effectiveness thresholds were defined as <$50,000 and <$150,000 per QALY gained, respectively. Results: At 10 years, the intervention was projected to cost an average of $2,356 (95% uncertainty interval [UI] -$264-$4,611) more per participant than the control arm and gain 0.06 (95% UI 0.01-0.10) QALYs. The LABBPS intervention was highly cost-effective, with a mean cost of $42,717 per QALY gained (58% probability of being highly and 96% of being at least intermediately cost-effective). Exclusive use of generic drugs improved the cost-effectiveness to $17,162 per QALY gained. The LABBPS intervention would be only intermediately cost effective if pharmacists were less likely to intensify antihypertensive medications when systolic blood pressure was ≥150 mmHg or if pharmacist weekly time driving to barbershops increased. Conclusions: Hypertension care delivered by clinical pharmacists in Black barbershops is a highly cost-effective way to improve blood pressure control in Black men.",2021,"The LABBPS intervention was highly cost-effective, with a mean cost of $42,717 per QALY gained (58% probability of being highly and 96% of being at least intermediately cost-effective).","['LABBPS participants', 'Pharmacists in Black Barbershops', 'Black barbershops', 'Black men', 'Hispanic Black men with uncontrolled hypertension at baseline']",['LABBPS intervention'],"['systolic blood pressure', '10-year health outcomes and healthcare costs', 'blood pressure, medication-related adverse events, fatal and non-fatal cardiovascular disease events, and non-cardiovascular disease death', 'cost-effectiveness', 'Program costs, total direct healthcare costs (2019 USD), and quality-adjusted life years (QALYs', 'Cost-effectiveness', 'blood pressure control']","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0346919,"The LABBPS intervention was highly cost-effective, with a mean cost of $42,717 per QALY gained (58% probability of being highly and 96% of being at least intermediately cost-effective).","[{'ForeName': 'Kelsey B', 'Initials': 'KB', 'LastName': 'Bryant', 'Affiliation': 'Columbia University, Vagelos College of Physicians and Surgeons, New York, NY.'}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Moran', 'Affiliation': 'Columbia University, Vagelos College of Physicians and Surgeons, New York, NY.'}, {'ForeName': 'Dhruv S', 'Initials': 'DS', 'LastName': 'Kazi', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, MA; Harvard Medical School, Boston, MA.'}, {'ForeName': 'Yiyi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Columbia University, Vagelos College of Physicians and Surgeons, New York, NY.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Penko', 'Affiliation': 'University of California San Francisco, School of Medicine, San Francisco, CA.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Ruiz-Negrón', 'Affiliation': 'University of Utah, College of Pharmacy, Salt Lake City, UT.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Coxson', 'Affiliation': 'University of California San Francisco, School of Medicine, San Francisco, CA.'}, {'ForeName': 'Ciantel A', 'Initials': 'CA', 'LastName': 'Blyler', 'Affiliation': 'Smidt Heart Institute, Cedars-Sinai Medical Center, Smidt Heart Institute, Los Angeles, CA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Lynch', 'Affiliation': ""Providence Saint John's Health Center, John Wayne Cancer Institute, Santa Monica, CA.""}, {'ForeName': 'Laura P', 'Initials': 'LP', 'LastName': 'Cohen', 'Affiliation': 'Columbia University, Vagelos College of Physicians and Surgeons, New York, NY.'}, {'ForeName': 'Gabriel S', 'Initials': 'GS', 'LastName': 'Tajeu', 'Affiliation': 'Temple University, College of Public Health, Philadelphia, PA.'}, {'ForeName': 'Valy', 'Initials': 'V', 'LastName': 'Fontil', 'Affiliation': 'University of California San Francisco, School of Medicine, San Francisco, CA.'}, {'ForeName': 'Norma B', 'Initials': 'NB', 'LastName': 'Moy', 'Affiliation': 'Smidt Heart Institute, Cedars-Sinai Medical Center, Smidt Heart Institute, Los Angeles, CA.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Ebinger', 'Affiliation': 'Smidt Heart Institute, Cedars-Sinai Medical Center, Smidt Heart Institute, Los Angeles, CA.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Rader', 'Affiliation': 'Smidt Heart Institute, Cedars-Sinai Medical Center, Smidt Heart Institute, Los Angeles, CA.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Bibbins-Domingo', 'Affiliation': 'University of California San Francisco, School of Medicine, San Francisco, CA.'}, {'ForeName': 'Brandon K', 'Initials': 'BK', 'LastName': 'Bellows', 'Affiliation': 'Columbia University, Vagelos College of Physicians and Surgeons, New York, NY.'}]",Circulation,['10.1161/CIRCULATIONAHA.120.051683'] 3839,33855859,A Preliminary Test of the Efficacy of Brief Self-Administered Behavioral Interventions for Rumination.,"Rumination is theorized to be a cognitive avoidance process that is implicated in several manifestations of psychopathology. Few interventions directly target rumination as a core process maintaining emotional disorder symptoms. This pilot study compared the feasibility and preliminary efficacy of self-directed behavioral approaches for reducing rumination. Participants ( N  = 60) with elevations in rumination were randomized to 3 weeks of self-directed interventions: (a) scheduled rumination time; (b) a strategy combining mindfulness, shaping, and disengagement strategies; or (c) self-monitoring control. Both active treatment conditions outperformed self-monitoring control on post-treatment depression scores. Scheduled rumination time significantly outperformed the other two conditions on measures of rumination and worry. No between-group differences emerged on the secondary outcome (i.e., anxiety symptoms). Brief, self-directed, behavioral interventions targeting rumination are feasible and demonstrate preliminary efficacy. Scheduled rumination time shows moderate to large effects. The use of a small, non-treatment seeking sample was the primary limitation.",2021,Scheduled rumination time significantly outperformed the other two conditions on measures of rumination and worry.,['Participants ( N \u2009=\u200960) with elevations in rumination'],"['self-directed interventions: (a) scheduled rumination time; (b) a strategy combining mindfulness, shaping, and disengagement strategies; or (c) self-monitoring control', 'Brief Self-Administered Behavioral Interventions', 'self-directed behavioral approaches']","['secondary outcome (i.e., anxiety symptoms', 'Scheduled rumination time', 'rumination and worry']","[{'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0233481', 'cui_str': 'Worried'}]",60.0,0.0299932,Scheduled rumination time significantly outperformed the other two conditions on measures of rumination and worry.,"[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Wolitzky-Taylor', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Breland', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Jaclyn', 'Initials': 'J', 'LastName': 'Ross', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Sewart', 'Affiliation': 'California State University - Dominguez Hills, CA, USA.'}]",Behavior modification,['10.1177/01454455211010701'] 3840,33855807,'Air Anatomy' - Teaching Complex Spatial Anatomy Using Simple Hand Gestures.,"Spatial understanding of complex anatomical concepts is often a challenge for learners, as well as for educators. It is even more challenging for students with low mental spatial abilities. There are many options to teach spatial relationships, ranging from simple models to high-end three-dimensional virtual reality tools. Using a randomized controlled trial design, this study explored the use of a unique combination of deictic and iconic hand gestures to enhance spatial anatomical understanding, coining the term 'Air Anatomy'. The control group (n=45) was given a lecture on the anatomy of extra-ocular muscles while the intervention group (n= 49) received the same lecture including 'Air Anatomy' hand gestures. When compared to the control group, the post-test scores for the intervention group were significantly higher for basic recall (P <0.001; Mann-Whitney U test) and for the application of knowledge (P = 0.015; Mann-Whitney U test). Students with low to moderate spatial ability (as assessed by a mental rotation test) were found to benefit most by this technique. Students in the intervention group also reported a lower extrinsic cognitive load and higher germane load, when compared to the control group. An instructional skills questionnaire survey indicated the effectiveness of this technique in improving overall classroom experience. Feedback of the students in the intervention group was also favorable for instruction using 'Air Anatomy'. The study suggests that 'Air Anatomy' is a useful, 'no-cost', accessible method that aids spatial understanding of anatomical concepts.",2021,"Students in the intervention group also reported a lower extrinsic cognitive load and higher germane load, when compared to the control group.",['students with low mental spatial abilities'],"[""lecture on the anatomy of extra-ocular muscles while the intervention group (n= 49) received the same lecture including 'Air Anatomy' hand gestures"", 'deictic and iconic hand gestures']","['lower extrinsic cognitive load', 'basic recall', 'overall classroom experience']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0679024', 'cui_str': 'Spatial Ability'}]","[{'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0028863', 'cui_str': 'Structure of extraocular muscle'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0017510', 'cui_str': 'Gestures'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",,0.016927,"Students in the intervention group also reported a lower extrinsic cognitive load and higher germane load, when compared to the control group.","[{'ForeName': 'Doris George', 'Initials': 'DG', 'LastName': 'Yohannan', 'Affiliation': 'Department of Anatomy, Government Medical College, Thiruvananthapuram, Kerala, India.'}, {'ForeName': 'Aswathy Maria', 'Initials': 'AM', 'LastName': 'Oommen', 'Affiliation': 'Department of Anatomy, Government Medical College, Thiruvananthapuram, Kerala, India.'}, {'ForeName': 'Bhaskaran Jayaprasad', 'Initials': 'BJ', 'LastName': 'Amogh', 'Affiliation': 'Government Medical College, Thiruvananthapuram, Kerala, India.'}, {'ForeName': 'Nithin Kadakampallil', 'Initials': 'NK', 'LastName': 'Raju', 'Affiliation': 'Department of Anatomy, Government Medical College, Thiruvananthapuram, Kerala, India.'}, {'ForeName': 'Rakesh Omana', 'Initials': 'RO', 'LastName': 'Suresh', 'Affiliation': 'Government Medical College, Thiruvananthapuram, Kerala, India.'}, {'ForeName': 'Santhanu Jagannath', 'Initials': 'SJ', 'LastName': 'Nair', 'Affiliation': 'Government Medical College, Thiruvananthapuram, Kerala, India.'}]",Anatomical sciences education,['10.1002/ase.2088'] 3841,33855805,Evaluation of the Potential Effect of Iptakalim Hydrochloride on the QT Interval in Single- and Multiple-Ascending-Dose Studies Using Concentration-QTc Analysis.,"Cardiotoxicity has been one of the most common causes of withdrawal of drugs from the market, and prolongation of the QT interval is one of the manifestations of drug cardiotoxicity. Iptakalim hydrochloride (ITKL) is a selective ATP-sensitive potassium channel opener used to treat hypertension. It is crucial to assess the risk of cardiac repolarization of ITKL in clinical trials. This study was conducted to determine the effect of ITKL on corrected QT (QTc) interval. A randomized, double-blind, placebo-controlled single- and multidose regimen was carried out to investigate the QTc and ITKL concentration correlation. ITKL was administered at doses of 5, 10, 15, and 20 mg with single oral administration and 10 and 20 mg with multiple oral administration, along with placebo, in 83 healthy subjects. Electrocardiograms (ECGs) and blood samples were collected on a preset time schedule. A ΔΔQTcF effect above 10 milliseconds was excluded at all observed plasma levels. Among them, the highest dose was 20 mg, which is twice the therapeutic dose. We concluded that ITKL did not prolong the QT interval in healthy subjects within the therapeutic dose. Retrospectively registered: The study was registered at Chinese Clinical Trial Registry with registration number ChiCTR1800014466.",2021,"Cardiotoxicity has been one of the most common causes of withdrawal of drugs from the market, and prolongation of the QT interval is one of the manifestations of drug cardiotoxicity.","['83 healthy subjects', 'healthy subjects']","['Iptakalim Hydrochloride', 'Iptakalim hydrochloride (ITKL', 'placebo', 'ITKL']","['QT interval', 'QT Interval', 'corrected QT (QTc) interval', 'Electrocardiograms (ECGs) and blood samples', 'QTc and ITKL concentration correlation']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1571168', 'cui_str': 'iptakalim'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C1571168', 'cui_str': 'iptakalim'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}]",83.0,0.208077,"Cardiotoxicity has been one of the most common causes of withdrawal of drugs from the market, and prolongation of the QT interval is one of the manifestations of drug cardiotoxicity.","[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Bai', 'Affiliation': ""Chinese People's Liberation Army General Hospital, Medicine Clinical Research Center, Beijing, China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Chinese People's Liberation Army General Hospital, Medicine Clinical Research Center, Beijing, China.""}, {'ForeName': 'Haoyue', 'Initials': 'H', 'LastName': 'Che', 'Affiliation': ""Chinese People's Liberation Army General Hospital, Medicine Clinical Research Center, Beijing, China.""}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Thadweik Academy of Medicine, Cardiovascular Drug Research Center, Beijing, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': ""Chinese People's Liberation Army General Hospital, Medicine Clinical Research Center, Beijing, China.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': ""Chinese People's Liberation Army General Hospital, Medicine Clinical Research Center, Beijing, China.""}]",Clinical pharmacology in drug development,['10.1002/cpdd.945'] 3842,33855796,Improved Cancer Coping from a Web-based Intervention for Prostate Cancer Survivors: A Randomized Controlled Trial.,"OBJECTIVES Prostate cancer (PCa) survivors report poor physical functioning alongside negative psychological outcomes as they cope with treatment side effects and practical concerns after treatment completion. This study evaluated PROGRESS, a web-based intervention designed to improve adaptive coping among PCa survivors. METHODS Localized PCa patients (N=431) within one year of treatment completion were randomized to receive educational booklets or PROGRESS + educational booklets. Surveys completed at baseline, 1-, 3-, and 6-months assessed patient characteristics; functional quality of life and coping (primary outcomes); and psychosocial outcomes (e.g., self-efficacy, marital communication; secondary outcomes). Intent-to-treat and as-treated analyses were completed to assess change in outcomes from baseline to 6 months using linear mixed effects regression models. RESULTS In the intent-to-treat analyses, participants randomized to the intervention group had improved diversion coping (i.e., healthy redirection of worrying thoughts about their cancer), but more difficulties in marital communication (ps<.05). However, PROGRESS usage was low among those randomized to the intervention group (38.7%). The as-treated analyses found PROGRESS users reported fewer practical concerns but had worse positive coping compared to PROGRESS non-users (ps<.05). CONCLUSIONS The findings suggest PROGRESS may improve certain aspects of adaptive coping among PCa survivors that use the website, but does not adequately address the remaining coping and psychosocial domains. Additional research is needed to better understand the gaps in intervention delivery contributing to low engagement and poor improvement across all domains of functional quality of life and adaptive coping. This article is protected by copyright. All rights reserved.",2021,"The as-treated analyses found PROGRESS users reported fewer practical concerns but had worse positive coping compared to PROGRESS non-users (ps<.05). ","['Localized PCa patients (N=431) within one year of treatment completion', 'Prostate Cancer Survivors', 'Prostate cancer (PCa) survivors']",['educational booklets or PROGRESS + educational booklets'],"['patient characteristics; functional quality of life and coping (primary outcomes); and psychosocial outcomes (e.g., self-efficacy, marital communication; secondary outcomes', 'diversion coping']","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0580352', 'cui_str': 'Treatment completed'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0185033', 'cui_str': 'Diversion procedure'}]",,0.161613,"The as-treated analyses found PROGRESS users reported fewer practical concerns but had worse positive coping compared to PROGRESS non-users (ps<.05). ","[{'ForeName': 'Erin K', 'Initials': 'EK', 'LastName': 'Tagai', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Miller', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Shawna V', 'Initials': 'SV', 'LastName': 'Hudson', 'Affiliation': 'Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Diefenbach', 'Affiliation': 'Feinstein Institute for Medical Research, Northwell Health, Manhasset, New York, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Handorf', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Alicja', 'Initials': 'A', 'LastName': 'Bator', 'Affiliation': 'Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Marziliano', 'Affiliation': 'Feinstein Institute for Medical Research, Northwell Health, Manhasset, New York, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kutikov', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Hall', 'Affiliation': 'Feinstein Institute for Medical Research, Northwell Health, Manhasset, New York, USA.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Vira', 'Affiliation': 'Feinstein Institute for Medical Research, Northwell Health, Manhasset, New York, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schwartz', 'Affiliation': 'Feinstein Institute for Medical Research, Northwell Health, Manhasset, New York, USA.'}, {'ForeName': 'Issac Yi', 'Initials': 'IY', 'LastName': 'Kim', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, USA.'}, {'ForeName': 'Sung', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, USA.'}]",Psycho-oncology,['10.1002/pon.5701'] 3843,33855726,"Therapeutic alliance as a predictor of behavioral outcomes in a relationally focused, family-centered telehealth intervention.","This study evaluates therapeutic alliance as a mediator of the relationship between dosage and clinical outcomes for the Family Check-Up (FCU) Online, a telehealth adaptation of an evidence-based parenting intervention for parents of middle school youth. The sample consisted of N = 111 parents with children in middle school who received the FCU Online as part of an ongoing clinical trial. They were randomly assigned to receive telehealth coaching and participated in the intervention and follow-up assessment 12 months later. Data was collected using parent and child questionnaires as well as engagement data collected as part of the online intervention, using both parents and children as reporters of parent behavioral change. Using parent report measures, there was clear support for a mediation model, with parent report of alliance predicting parent self-report ratings of clinical progress (parent behavior change) at 12-month follow-up. However, for the child-report data, there was no clear relationship between dosage or therapeutic alliance with child reports of parenting. Clinical implications and future research directions are discussed.",2021,They were randomly assigned to receive telehealth coaching and participated in the intervention and follow-up assessment 12 months later.,"['111 parents with children in middle school who received the FCU Online as part of an ongoing clinical trial', 'parents of middle school youth']","['evidence-based parenting intervention', 'Family Check-Up (FCU', 'telehealth coaching']",[],"[{'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0420160', 'cui_str': 'History and physical examination, school'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0420160', 'cui_str': 'History and physical examination, school'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}]",[],111.0,0.036794,They were randomly assigned to receive telehealth coaching and participated in the intervention and follow-up assessment 12 months later.,"[{'ForeName': 'Robyn E', 'Initials': 'RE', 'LastName': 'Metcalfe', 'Affiliation': 'Department of Counseling and Human Services, Prevention Science Institute, University of Oregon, Eugene, OR, USA.'}, {'ForeName': 'Jordan M', 'Initials': 'JM', 'LastName': 'Matulis', 'Affiliation': 'Department of Counseling and Human Services, Prevention Science Institute, University of Oregon, Eugene, OR, USA.'}, {'ForeName': 'Yijun', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Counseling and Human Services, Prevention Science Institute, University of Oregon, Eugene, OR, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Stormshak', 'Affiliation': 'Department of Counseling and Human Services, Prevention Science Institute, University of Oregon, Eugene, OR, USA.'}]",Journal of marital and family therapy,['10.1111/jmft.12517'] 3844,33855673,Predictors of Caregiver Participation in an Engagement Strategy to Increase Initiation into a Family-Based Preventive Intervention.,"Previous studies have shown that engagement strategies can help increase enrollment and initiation of families in evidence-based preventive programs under natural service delivery settings. However, little is known about factors that predict completion of these engagement strategies. This study aimed to examine predictors (i.e., perceived need, perceived barriers, and sociocultural context) of caregiver participation in an evidence-based engagement call strategy. This call was expected to increase initiation into a school-based, family-focused prevention program. In addition, this study examined engagement call completion as a predictor of program initiation among already enrolled families. Participants included ethnically diverse families recruited from three Title I schools (n = 413) who were randomized to receive the prevention program. Results showed that interparental conflict-an indicator of perceived need-was associated with an increased likelihood of completing the engagement call. Furthermore, caregivers from low-socioeconomic status (SES), foreign-born, Spanish-speaking, Hispanic families were more likely to complete the call relative to those from low- and mid-SES, US born, English-speaking, ethnically diverse families. Importantly, engagement call completion was associated with an increased likelihood of program initiation. These findings provide limited support that families with higher perceived needs are more likely to participate in an evidence-based engagement call strategy. Results suggested that the call strategy provides a promising way to reduce attrition from family prevention programs, which is commonly observed between enrollment and initiation. Project Number: R01 DA035855; Date of Registration: 06/15/2014.",2021,Results showed that interparental conflict-an indicator of perceived need-was associated with an increased likelihood of completing the engagement call.,"['Participants included ethnically diverse families recruited from three Title I schools (n\xa0=\xa0413', 'Project Number']",[],[],"[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",[],[],413.0,0.0510869,Results showed that interparental conflict-an indicator of perceived need-was associated with an increased likelihood of completing the engagement call.,"[{'ForeName': 'Hardian', 'Initials': 'H', 'LastName': 'Thamrin', 'Affiliation': 'Department of Psychology, Arizona State University, Phoenix, AZ, USA. hthamrin@asu.edu.'}, {'ForeName': 'Emily B', 'Initials': 'EB', 'LastName': 'Winslow', 'Affiliation': 'Department of Psychology, Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'Daisy E', 'Initials': 'DE', 'LastName': 'Camacho-Thompson', 'Affiliation': 'Department of Psychology, California State University, Los Angeles, CA, USA.'}, {'ForeName': 'Xochitl Arlene', 'Initials': 'XA', 'LastName': 'Smola', 'Affiliation': 'Department of Psychology, Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'Alondra M', 'Initials': 'AM', 'LastName': 'Cruz', 'Affiliation': 'Department of Psychology, Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'Vanesa M', 'Initials': 'VM', 'LastName': 'Perez', 'Affiliation': 'Department of Psychology, Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'Sarah G', 'Initials': 'SG', 'LastName': 'Hidalgo', 'Affiliation': 'Department of Psychology, Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'Jenn-Yun', 'Initials': 'JY', 'LastName': 'Tein', 'Affiliation': 'Department of Psychology, Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Gonzales', 'Affiliation': 'Department of Psychology, Arizona State University, Phoenix, AZ, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-021-01242-7'] 3845,33855672,Evaluation of the One Love Escalation Workshop for Dating Abuse Prevention: a Randomized Controlled Trial Pilot Study with a Sample of US Navy Sailors.,"The purpose of this study was to evaluate the efficacy of the Escalation Workshop with a sample of US Navy sailors. Escalation is a one-session workshop designed to promote bystander behavior related to dating abuse. We conducted a two-arm RCT with follow-up at 4 and 8 months. Participants were 335 Navy sailors, recruited from two comparable ships based in the USA. The unit of randomization was the ship. The primary outcomes were as follows: (a) attitudes related to intervening as a bystander in dating abuse situations, (b) injunctive norms about dating abuse, (c) dating abuse-related prevention-oriented behaviors (e.g., such as posting dating violence prevention messages online), and (d) bystander behaviors including acting as a bystander to prevent peer self-harm, peer bullying, peer intoxication, or peer dating abuse, or being a proactive bystander and initiating conversations about dating abuse prevention with friends and others. Hierarchal linear models (HLMs) indicated that, compared to participants in the control group, participants in the intervention group demonstrated improvement in attitudes [β = .09, p < .001] and had more engagement than controls in prevention-oriented behavior at 8-month follow-up [β = 0.11, p < .01]. Those in the intervention group also reported larger increases than controls in bystander behavior related to peer self-harm, peer bullying, peer intoxication, and starting conversations about dating abuse. Results for dating abuse bystander behavior were mixed. At 4 months, workshop participation was marginally associated with increased bystander behavior with peers who had perpetrated dating abuse (β = 0.89, p = 0.06) and with peers experiencing physical or sexual dating abuse, or stalking or threats (β = 1.11, p = .07). However, workshop participation was not associated with increased bystander behavior with peers experiencing only physical abuse. The Escalation Workshop may be a promising strategy to promote change in dating abuse-related attitudinal change and prevention-oriented behavior, and bystander behavior with peers related to self-harm, bullying, intoxication, and some aspects of dating abuse prevention.",2021,"At 4 months, workshop participation was marginally associated with increased bystander behavior with peers who had perpetrated dating abuse (β = 0.89, p = 0.06) and with peers experiencing physical or sexual dating abuse, or stalking or threats (β = 1.11, p = .07).","['Dating Abuse Prevention', 'Participants were 335 Navy sailors, recruited from two comparable ships based in the USA']",[],"['peers experiencing physical or sexual dating abuse, or stalking or threats', 'bystander behavior related to peer self-harm, peer bullying, peer intoxication, and starting conversations about dating abuse', 'follows: (a) attitudes related to intervening as a bystander in dating abuse situations, (b) injunctive norms about dating abuse, (c) dating abuse-related prevention-oriented behaviors (e.g., such as posting dating violence prevention messages online), and (d) bystander behaviors including acting as a bystander to prevent peer self-harm, peer bullying, peer intoxication, or peer dating abuse, or being a proactive bystander and initiating conversations about dating abuse prevention with friends and others', 'Hierarchal linear models (HLMs', 'bystander behavior']","[{'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C1261558', 'cui_str': 'Abuse prevention'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C0524646', 'cui_str': 'Sailors'}, {'cui': 'C0036971', 'cui_str': 'Ship'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]",[],"[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0935572', 'cui_str': 'Stalking'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0085271', 'cui_str': 'Self-injurious behavior'}, {'cui': 'C0424318', 'cui_str': 'Bullying'}, {'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0032993', 'cui_str': 'Post-term pregnancy'}, {'cui': 'C0150215', 'cui_str': 'Violence prevention'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0566067', 'cui_str': 'Does initiate conversation'}, {'cui': 'C1261558', 'cui_str': 'Abuse prevention'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0023732', 'cui_str': 'Models, Linear'}]",335.0,0.0411103,"At 4 months, workshop participation was marginally associated with increased bystander behavior with peers who had perpetrated dating abuse (β = 0.89, p = 0.06) and with peers experiencing physical or sexual dating abuse, or stalking or threats (β = 1.11, p = .07).","[{'ForeName': 'Emily F', 'Initials': 'EF', 'LastName': 'Rothman', 'Affiliation': 'School of Public Health, Boston University, 801 Massachusetts Ave, Boston, MA, 02118, USA. erothman@bu.edu.'}, {'ForeName': 'Julia K', 'Initials': 'JK', 'LastName': 'Campbell', 'Affiliation': 'School of Public Health, Boston University, 801 Massachusetts Ave, Boston, MA, 02118, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Quinn', 'Affiliation': 'School of Public Health, Boston University, 801 Massachusetts Ave, Boston, MA, 02118, USA.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': 'Office of the Chief of Naval Operations, Washington, USA.'}, {'ForeName': 'Ziming', 'Initials': 'Z', 'LastName': 'Xuan', 'Affiliation': 'School of Public Health, Boston University, 801 Massachusetts Ave, Boston, MA, 02118, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-021-01240-9'] 3846,33855653,Efficacy and Safety of the Association of Nimodipine and Choline Alphoscerate in the Treatment of Cognitive Impairment in Patients with Cerebral Small Vessel Disease. The CONIVaD Trial.,"BACKGROUND No approved treatment is available for patients with vascular cognitive impairment (VCI) due to cerebral small vessel disease (SVD). OBJECTIVE The CONIVaD (Choline Alphoscerate and Nimodipine in Vascular Dementia) study aimed to investigate the feasibility, efficacy, and safety of a combined treatment with choline alphoscerate and nimodipine in patients with SVD and mild-to-moderate cognitive impairment. METHODS Within this pilot, single-center (university hospital), double-blinded, randomized clinical trial, patients were randomized to two arms: 1-year treatment with nimodipine 30 mg three times a day (TID) plus choline alphoscerate 600 mg twice a day (BID) (arm 1) or nimodipine 30 mg TID plus placebo BID (arm 2). Patients underwent an evaluation at baseline and after 12 months. Cognitive decline, defined as a ≥ 2-point loss on the Montreal Cognitive Assessment, was the primary endpoint. Functional, quality of life, other cognitive measures, and safety were secondary endpoints. Treatment adherence was measured by the count of medicine bottles returned by patients. RESULTS Sixty-two patients were randomized (31 each arm). Fourteen patients (22%) dropped out for reasons including consent withdrawal (n = 9), adverse reactions (n = 4), and stroke (n = 1). Forty-eight patients (mean ± SD age 75.1 ± 6.8 years), well balanced between arms, completed the study. Regarding adherence, of the prescribed total drug dose, > 75% was taken by 96% of patients for choline alphoscerate, 87.5% for placebo, and 15% for nimodipine. No statistically significant differences were found between the treatment groups for the primary cognitive outcome, nor for the secondary outcomes. Eight patients had non-serious adverse reactions; five presented adverse events. CONCLUSION Patients' adherence to treatment was low. With this limitation, the combined choline alphoscerate-nimodipine treatment showed no significant effect in our cohort of VCI patients with SVD. The safety profile was good overall. TRIAL REGISTRATION Clinical Trial NCT03228498. Registered 25 July 2017.",2021,"No statistically significant differences were found between the treatment groups for the primary cognitive outcome, nor for the secondary outcomes.","['patients with vascular cognitive impairment (VCI) due to cerebral small vessel disease (SVD', 'VCI patients with SVD', 'patients with SVD and mild-to-moderate cognitive impairment', 'Patients with Cerebral Small Vessel Disease', 'Forty-eight patients (mean ± SD age 75.1 ± 6.8 years']","['choline alphoscerate and nimodipine', 'nimodipine 30 mg TID plus placebo BID', 'CONIVaD (Choline Alphoscerate and Nimodipine', 'Nimodipine and Choline Alphoscerate', 'nimodipine 30 mg three times a day (TID) plus choline alphoscerate', 'placebo', 'nimodipine']","['Functional, quality of life, other cognitive measures, and safety', 'non-serious adverse reactions', 'Treatment adherence', 'Efficacy and Safety', 'count of medicine bottles', 'Cognitive Impairment', 'adverse reactions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3805043', 'cui_str': 'Vascular cognitive impairment'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C2733158', 'cui_str': 'Small vessel cerebrovascular disease'}, {'cui': 'C0225988', 'cui_str': 'Structure of small blood vessel (organ)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0017889', 'cui_str': 'choline alfoscerate'}, {'cui': 'C0028094', 'cui_str': 'Nimodipine'}, {'cui': 'C0988144', 'cui_str': 'Nimodipine 30 MG'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0179385', 'cui_str': 'Medicine bottle'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]",62.0,0.29714,"No statistically significant differences were found between the treatment groups for the primary cognitive outcome, nor for the secondary outcomes.","[{'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Salvadori', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Poggesi', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Donnini', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Rinnoci', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Chiti', 'Affiliation': 'NEUROFARBA Department, University of Florence, Florence, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Squitieri', 'Affiliation': 'NEUROFARBA Department, University of Florence, Florence, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Tudisco', 'Affiliation': 'NEUROFARBA Department, University of Florence, Florence, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Fierini', 'Affiliation': 'Psychiatry Unit, Department of Health Sciences, University of Florence, Florence, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Melone', 'Affiliation': 'NEUROFARBA Department, University of Florence, Florence, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Pescini', 'Affiliation': 'Stroke Unit, Emergency Department, Azienda Ospedaliero Universitaria Careggi, Florence, Italy.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Pantoni', 'Affiliation': ""Department of Biomedical and Clinical Sciences, 'L. Sacco' Hospital, University of Milan, Via Giovanni Battista Grassi 74, 20157, Milan, Italy. leonardo.pantoni@unimi.it.""}]",Drugs & aging,['10.1007/s40266-021-00852-8'] 3847,33855642,"Pilot randomized sham-controlled trial of self-acupressure to manage the symptom cluster of insomnia, depression, and anxiety in cancer patients undergoing chemotherapy.","PURPOSE Current evidence for using self-acupressure to manage the cancer-related symptom cluster of insomnia, depression, and anxiety, while promising, is unknown. This study evaluated the feasibility of self-acupressure to manage this symptom cluster and to explore its potential effectiveness. METHODS Participants were assigned randomly to three study groups, namely the true acupressure (TAP), the sham acupressure (SAP), and the enhanced standard care group (ESC). Participants in the TAP and SAP groups received a training session on acupressure and were required to practice self-acupressure at home once per day for 28 days. The duration of participant involvement was 8 weeks. Patients completed a Numerical Rating Scale (NRS) for each symptom, the Insomnia Severity Index, the Hospital Anxiety and Depression Scale, and the Functional Assessment of Cancer Therapy-General at baseline (T1), post-intervention (T2, week 4), and post follow-up (T3, week 8). RESULTS The results indicated that the intervention had clinical significance in improving the targeted symptoms and quality of life. In the TAP group, the symptom cluster severity was significantly lower than in the other groups at T2 (p < 0.05). The insomnia severity and anxiety scores in the TAP and SAP groups were significantly lower than those in ESC at T2 and T3 (p < 0.05). CONCLUSION The trial was feasible. The promising results of the study suggest that further testing of self-acupressure is warranted to inform its effectiveness on the targeted symptom cluster in patients with cancer. A placebo effect was evident alongside therapeutic effects. TRIAL REGISTRATION ClinicalTrials.gov (ID: NCT03823456) on January 30th, 2019.",2021,"The insomnia severity and anxiety scores in the TAP and SAP groups were significantly lower than those in ESC at T2 and T3 (p < 0.05). ","['Participants', 'cancer patients undergoing chemotherapy', 'patients with\xa0cancer']","['true acupressure (TAP), the sham acupressure (SAP), and the enhanced standard care group (ESC', 'TAP', 'self-acupressure', 'placebo', 'training session on acupressure and were required to practice self-acupressure']","['targeted symptoms and quality of life', 'Numerical Rating Scale (NRS) for each symptom, the Insomnia Severity Index, the Hospital Anxiety and Depression Scale, and the Functional Assessment of Cancer Therapy-General', 'symptom cluster severity', 'insomnia severity and anxiety scores', 'symptom cluster of insomnia, depression, and anxiety']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205238', 'cui_str': 'True'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.227397,"The insomnia severity and anxiety scores in the TAP and SAP groups were significantly lower than those in ESC at T2 and T3 (p < 0.05). ","[{'ForeName': 'Hoang Thi Xuan', 'Initials': 'HTX', 'LastName': 'Huong', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, 11 Yuk Choi Rd, Hung Hom, Kowloon, Hong Kong. xuan-huong.hoangthi@connect.polyu.hk.'}, {'ForeName': 'Molassiotis', 'Initials': 'M', 'LastName': 'Alex', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, 11 Yuk Choi Rd, Hung Hom, Kowloon, Hong Kong.'}, {'ForeName': 'Chan Choi', 'Initials': 'CC', 'LastName': 'Wan', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, 11 Yuk Choi Rd, Hung Hom, Kowloon, Hong Kong.'}, {'ForeName': 'Vu Hoang', 'Initials': 'VH', 'LastName': 'Anh', 'Affiliation': 'Faculty of Nursing, Phenikaa University, Hanoi, Vietnam.'}, {'ForeName': 'Bui Thanh', 'Initials': 'BT', 'LastName': 'Phuc', 'Affiliation': 'Vietnam-Germany University Hospital, Hanoi, Vietnam.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-021-02370-8'] 3848,33855612,Paired exercise has superior effects on psychosocial health compared to individual exercise in female cancer patients.,"PURPOSE Exercise improves the quality of life (QOL) in cancer patients recovering from treatment. Since group exercise fosters cohesion, we sought to determine if paired exercise would have similar, positive effects. An experiential study design was used to compare the effect of exercise (12 weeks) on psychosocial health in paired versus individually trained cancer patients. METHODS Female cancer patients (n = 28) who completed cancer treatment were placed into either the singly trained or paired group. Groups were matched for cardiorespiratory fitness (peak oxygen consumption, single: 24.1 ± 7.4, pair: 24.8 ± 6.3 ml/kg/min) and age (single: 58 ± 12, pair: 58 ± 9 years). Patients participated in 36, 90-min exercise sessions in accordance with exercise recommendations. QOL (Functional Assessment of Cancer Therapy-General, FACT-G), depressive, fatigue, and insomnia symptoms were measured before, midway, and after the intervention. Fitness was measured pre- and post-intervention. Participants did not meet prior to the intervention. Two-way ANOVAs and multiple comparisons tests were used to detect differences (p < 0.05). RESULTS Emotional well-being and total FACT-G scores were significantly improved in the paired but not individually trained patients. Depressive symptoms were significantly improved at mid- and final time points in the paired group. Paired patients reported significant improvements in insomnia symptoms from pre- to mid-intervention. Depressive and insomnia symptoms in the individually trained group were unchanged. A significant main effect of group was detected in fatigue scores in patients who were not chronically tired at baseline (F(1, 12) = 6.318, p = 0.0272). Both groups exhibited similar improvements in fitness. CONCLUSION Paired exercisers had greater benefits in QOL, emotional well-being, and insomnia and depressive symptoms compared to individual exercisers.",2021,"A significant main effect of group was detected in fatigue scores in patients who were not chronically tired at baseline (F(1, 12) =","['Groups were matched for cardiorespiratory fitness (peak oxygen consumption, single: 24.1 ± 7.4, pair: 24.8 ± 6.3 ml/kg/min) and age (single: 58 ± 12, pair: 58 ± 9 years', 'female cancer patients', 'patients who were not chronically tired at baseline (F(1, 12) ', 'Female cancer patients (n = 28) who completed cancer treatment', 'paired versus individually trained cancer patients', 'cancer patients recovering from treatment']",['Paired exercise'],"['Depressive and insomnia symptoms', 'quality of life (QOL', 'Emotional well-being and total FACT-G scores', 'fitness', 'Depressive symptoms', 'fatigue scores', 'psychosocial health', 'insomnia symptoms', 'QOL, emotional well-being, and insomnia and depressive symptoms', 'QOL (Functional Assessment of Cancer Therapy-General, FACT-G), depressive, fatigue, and insomnia symptoms']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",,0.0530647,"A significant main effect of group was detected in fatigue scores in patients who were not chronically tired at baseline (F(1, 12) =","[{'ForeName': 'Paulette M', 'Initials': 'PM', 'LastName': 'Yamada', 'Affiliation': 'Department of Kinesiology and Rehabilitative Science, University of Hawaii, Manoa, 1337 Lower Campus Road PE/A 231, Honolulu, HI, 96822, USA. pyamada@hawaii.edu.'}, {'ForeName': 'Cheri', 'Initials': 'C', 'LastName': 'Teranishi-Hashimoto', 'Affiliation': 'Rehabilitation Hospital of the Pacific, Honolulu, HI, USA.'}, {'ForeName': 'Erin O', 'Initials': 'EO', 'LastName': 'Bantum', 'Affiliation': 'Population Sciences in the Pacific Program, University of Hawaii Cancer Center, Honolulu, HI, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-021-06209-6'] 3849,33855585,Baseline Interleukin-6 and -8 predict response and survival in patients with advanced hepatocellular carcinoma treated with sorafenib monotherapy: an exploratory post hoc analysis of the SORAMIC trial.,"PURPOSE To explore the potential correlation between baseline interleukin (IL) values and overall survival or objective response in patients with hepatocellular carcinoma (HCC) receiving sorafenib. METHODS A subset of patients with HCC undergoing sorafenib monotherapy within a prospective multicenter phase II trial (SORAMIC, sorafenib treatment alone vs. combined with Y90 radioembolization) underwent baseline IL-6 and IL-8 assessment before treatment initiation. In this exploratory post hoc analysis, the best cut-off points for baseline IL-6 and IL-8 values predicting overall survival (OS) were evaluated, as well as correlation with the objective response. RESULTS Forty-seven patients (43 male) with a median OS of 13.8 months were analyzed. Cut-off values of 8.58 and 57.9 pg/mL most effectively predicted overall survival for IL-6 and IL-8, respectively. Patients with high IL-6 (HR, 4.1 [1.9-8.9], p < 0.001) and IL-8 (HR, 2.4 [1.2-4.7], p = 0.009) had significantly shorter overall survival than patients with low IL values. Multivariate analysis confirmed IL-6 (HR, 2.99 [1.22-7.3], p = 0.017) and IL-8 (HR, 2.19 [1.02-4.7], p = 0.044) as independent predictors of OS. Baseline IL-6 and IL-8 with respective cut-off values predicted objective response rates according to mRECIST in a subset of 42 patients with follow-up imaging available (IL-6, 46.6% vs. 19.2%, p = 0.007; IL-8, 50.0% vs. 17.4%, p = 0.011). CONCLUSION IL-6 and IL-8 baseline values predicted outcomes of sorafenib-treated patients in this well-characterized prospective cohort of the SORAMIC trial. We suggest that the respective cut-off values might serve for validation in larger cohorts, potentially offering guidance for improved patient selection.",2021,Multivariate analysis confirmed IL-6,"['patients with hepatocellular carcinoma (HCC) receiving sorafenib', 'Forty-seven patients (43 male) with a median OS of 13.8\xa0months were analyzed', 'patients with HCC undergoing', 'patients with advanced hepatocellular carcinoma treated with']","['sorafenib monotherapy', 'sorafenib treatment alone vs. combined with Y90 radioembolization', 'IL-6', 'sorafenib']","['Baseline Interleukin-6 and -8 predict response and survival', 'baseline IL-6 and IL-8 values predicting overall survival (OS', 'baseline interleukin (IL) values and overall survival or objective response', 'Baseline IL-6 and IL-8 with respective cut-off values predicted objective response rates', 'IL-8', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C4517561', 'cui_str': '13.8'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C2985560', 'cui_str': 'Radioembolisation'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}]",47.0,0.312143,Multivariate analysis confirmed IL-6,"[{'ForeName': 'Osman', 'Initials': 'O', 'LastName': 'Öcal', 'Affiliation': 'Department of Radiology, University Hospital, Ludwig Maximilian University of Munich, Marchioninistrasse 15, 81377, Munich, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Schütte', 'Affiliation': 'Department of Internal Medicine and Gastroenterology, Niels-Stensen-Kliniken Marienhospital, Osnabrück, Germany.'}, {'ForeName': 'Juozas', 'Initials': 'J', 'LastName': 'Kupčinskas', 'Affiliation': 'Institute for Digestive Research and Department of Gastroenterology, Medical Academy, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Egidijus', 'Initials': 'E', 'LastName': 'Morkunas', 'Affiliation': 'Institute for Digestive Research and Department of Gastroenterology, Medical Academy, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Gabija', 'Initials': 'G', 'LastName': 'Jurkeviciute', 'Affiliation': 'Institute for Digestive Research and Department of Gastroenterology, Medical Academy, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Enrico N', 'Initials': 'EN', 'LastName': 'de Toni', 'Affiliation': 'Department of Medicine II, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Najib', 'Initials': 'N', 'LastName': 'Ben Khaled', 'Affiliation': 'Department of Medicine II, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Berg', 'Affiliation': 'Klinik Und Poliklinik Für Gastroenterologie, Sektion Hepatologie, Universitätsklinikum Leipzig, Leipzig, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Malfertheiner', 'Affiliation': 'Department of Medicine II, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Heinz Josef', 'Initials': 'HJ', 'LastName': 'Klümpen', 'Affiliation': 'Department of Medical Oncology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sengel', 'Affiliation': 'Radiology Department, Grenoble University Hospital, La Tronche, France.'}, {'ForeName': 'Bristi', 'Initials': 'B', 'LastName': 'Basu', 'Affiliation': 'Department of Oncology, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Juan W', 'Initials': 'JW', 'LastName': 'Valle', 'Affiliation': 'Division of Cancer Sciences and Department of Medical Oncology, The Christie NHS Foundation Trust, University of Manchester, Manchester, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Benckert', 'Affiliation': 'Department of Hepatology and Gastroenterology, Charité-Universitätsmedizin Berlin, Campus Virchow Klinikum, Berlin, Germany.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gasbarrini', 'Affiliation': ""Fondazione Policlinico Universitario Gemelli IRCCS, Universita' Cattolica del Sacro Cuore, Roma, Italy.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Palmer', 'Affiliation': 'Molecular and Clinical Cancer Medicine, University Hospitals and Clatterbridge, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Ricarda', 'Initials': 'R', 'LastName': 'Seidensticker', 'Affiliation': 'Department of Radiology, University Hospital, Ludwig Maximilian University of Munich, Marchioninistrasse 15, 81377, Munich, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Wildgruber', 'Affiliation': 'Department of Radiology, University Hospital, Ludwig Maximilian University of Munich, Marchioninistrasse 15, 81377, Munich, Germany.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Sangro', 'Affiliation': 'Liver Unit, Clínica Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Pech', 'Affiliation': 'Departments of Radiology and Nuclear Medicine, University of Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Ricke', 'Affiliation': 'Department of Radiology, University Hospital, Ludwig Maximilian University of Munich, Marchioninistrasse 15, 81377, Munich, Germany.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Seidensticker', 'Affiliation': 'Department of Radiology, University Hospital, Ludwig Maximilian University of Munich, Marchioninistrasse 15, 81377, Munich, Germany. max.seidensticker@med.uni-muenchen.de.'}]",Journal of cancer research and clinical oncology,['10.1007/s00432-021-03627-1'] 3850,33855449,IV and oral fosfomycin pharmacokinetics in neonates with suspected clinical sepsis.,"BACKGROUND Fosfomycin has the potential to be re-purposed as part of a combination therapy to treat neonatal sepsis where resistance to current standard of care (SOC) is common. Limited data exist on neonatal fosfomycin pharmacokinetics and estimates of bioavailability and CSF/plasma ratio in this vulnerable population are lacking. OBJECTIVES To generate data informing the appropriate dosing of IV and oral fosfomycin in neonates using a population pharmacokinetic analysis of plasma and CSF data. METHODS The NeoFosfo study (NCT03453177) was a randomized trial that examined the safety and pharmacokinetics of fosfomycin comparing SOC versus SOC plus fosfomycin. Sixty-one neonates received fosfomycin (100 mg/kg IV q12h for 48 h) and then they converted to oral therapy at the same dose. Two plasma pharmacokinetic samples were taken following the first IV and oral doses, sample times were randomized to cover the whole pharmacokinetic profile and opportunistic CSF pharmacokinetic samples were collected. A population pharmacokinetic model was developed in NONMEM and simulations were performed. RESULTS In total, 238 plasma and 15 CSF concentrations were collected. A two-compartment disposition model, with an additional CSF compartment and first-order absorption, best described the data. Bioavailability was estimated as 0.48 (95% CI = 0.347-0.775) and the CSF/plasma ratio as 0.32 (95% CI = 0.272-0.409). Allometric weight and postmenstrual age (PMA) scaling was applied; additional covariates included postnatal age (PNA) on clearance and CSF protein on CSF/plasma ratio. CONCLUSIONS Through this analysis a population pharmacokinetic model has been developed that can be used alongside currently available pharmacodynamic targets to select a neonatal fosfomycin dose based on an infant's PMA, PNA and weight.",2021,Bioavailability was estimated as 0.48 (95% CI = 0.347-0.775) and the CSF/plasma ratio as 0.32 (95% CI = 0.272-0.409).,['neonates with suspected clinical sepsis'],['fosfomycin'],"['clearance and CSF protein on CSF/plasma ratio', 'Bioavailability', 'CSF/plasma ratio', '238 plasma and 15 CSF concentrations', 'bioavailability and CSF/plasma ratio', 'Allometric weight and postmenstrual age (PMA) scaling']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C3164780', 'cui_str': 'Clinical sepsis'}]","[{'cui': 'C0016610', 'cui_str': 'Fosfomycin'}]","[{'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0201943', 'cui_str': 'Measurement of protein in cerebrospinal fluid specimen'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",,0.251433,Bioavailability was estimated as 0.48 (95% CI = 0.347-0.775) and the CSF/plasma ratio as 0.32 (95% CI = 0.272-0.409).,"[{'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Kane', 'Affiliation': 'Infection, Immunity and Inflammation, Great Ormond Street Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Gastine', 'Affiliation': 'Infection, Immunity and Inflammation, Great Ormond Street Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Obiero', 'Affiliation': 'KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya.'}, {'ForeName': 'Phoebe', 'Initials': 'P', 'LastName': 'Williams', 'Affiliation': 'KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Murunga', 'Affiliation': 'KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya.'}, {'ForeName': 'Johnstone', 'Initials': 'J', 'LastName': 'Thitiri', 'Affiliation': 'KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Ellis', 'Affiliation': 'GARDP-Global Antibiotic Research & Development Partnership, Genève, Switzerland.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Correia', 'Affiliation': 'GARDP-Global Antibiotic Research & Development Partnership, Genève, Switzerland.'}, {'ForeName': 'Borna', 'Initials': 'B', 'LastName': 'Nyaoke', 'Affiliation': 'DNDi-Drugs for Neglected Diseases initiative, Nairobi, Kenya.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Kipper', 'Affiliation': 'Institute of Chemistry, University of Tartu, Tartu, Estonia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'van den Anker', 'Affiliation': ""Department of Paediatric Pharmacology and Pharmacometrics, University Children's Hospital Basel, University of Basel, Basel, Switzerland.""}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Sharland', 'Affiliation': ""Paediatric Infectious Diseases Research Group, Institute for Infection and Immunity, St George's, University of London, London, UK.""}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Berkley', 'Affiliation': 'KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Standing', 'Affiliation': 'Infection, Immunity and Inflammation, Great Ormond Street Institute of Child Health, University College London, London, UK.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkab083'] 3851,33855419,The intervention of maternal nutrition literacy has the potential to prevent childhood stunting: Randomized control trials.,"BACKGROUND Stunting is the impaired growth and development of children due to poor nutrition, repeated infection, and inadequate psychological stimulation. This research aims to examine the impact of maternal nutrition literacy (MNL) in increasing the height or score of a stunted child. DESIGN AND METHODS This study is a randomized control trial, which uses a sample size of 85 participants, 43 interventions and 42 controls, an 80% stress test and a 95% confidence level. The intervention group of the MNL consists of families with children under the age of five, focused on the mother's ability to perform breastfeeding, hygiene activities, care, and intervention for 3 months. RESULT The status of stunting was determined by the different distribution of stunting before and after the intervention in both the intervention and control groups. There was a decrease of about 9.3% of MNL in the intervention group, while in the control group it decreased by just 2.4% (p<0.05). CONCLUSIONS It can be concluded that MNL has an effect in preventing stunting, and it is recommended that preventive measures should focus more on normal children, while stunted children should be provided with breastfeeding as the core of MNL.",2021,"There was a decrease of about 9.3% of MNL in the intervention group, while in the control group it decreased by just 2.4% (p<0.05). ","['childhood stunting', '85 participants, 43 interventions and 42 controls, an 80% stress test and a 95% confidence level']","['MNL', 'maternal nutrition literacy (MNL', 'maternal nutrition literacy']",['status of stunting'],"[{'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C1720845', 'cui_str': 'Maternal Nutritional Physiological Phenomenon'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}]","[{'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}]",,0.0398251,"There was a decrease of about 9.3% of MNL in the intervention group, while in the control group it decreased by just 2.4% (p<0.05). ","[{'ForeName': 'Sirajuddin', 'Initials': 'S', 'LastName': 'Sirajuddin', 'Affiliation': 'Student Doctoral Public Health, Hasanuddin University, Makassar; Department of Dietetic and Nutrition, Health Polytechnic of Makassar. sirajuddin.gizi@poltekkes-mks.ac.id.'}, {'ForeName': 'Saifuddin', 'Initials': 'S', 'LastName': 'Sirajuddin', 'Affiliation': 'Department of Health Nutrition, Faculty of Medicine, Gadjah Mada University, Yogyakarta. sirajuddin.gizi@poltekkes-mks.ac.id.'}, {'ForeName': 'Amran', 'Initials': 'A', 'LastName': 'Razak', 'Affiliation': 'Department of Health Nutrition, Faculty of Medicine, Gadjah Mada University, Yogyakarta. sirajuddin.gizi@poltekkes-mks.ac.id.'}, {'ForeName': 'Ansariadi', 'Initials': 'A', 'LastName': 'Ansariadi', 'Affiliation': 'Department of Health Nutrition, Faculty of Medicine, Gadjah Mada University, Yogyakarta. sirajuddin.gizi@poltekkes-mks.ac.id.'}, {'ForeName': 'Ridwan M', 'Initials': 'RM', 'LastName': 'Thaha', 'Affiliation': 'Department of Health Nutrition, Faculty of Medicine, Gadjah Mada University, Yogyakarta. sirajuddin.gizi@poltekkes-mks.ac.id.'}, {'ForeName': 'Toto', 'Initials': 'T', 'LastName': 'Sudargo', 'Affiliation': 'Faculty Public Health Hasanuddin University, Makassar. sirajuddin.gizi@poltekkes-mks.ac.id.'}]",Journal of public health research,['10.4081/jphr.2021.2235'] 3852,33855405,Effect of Moringa oleifera supplementation during pregnancy on the prevention of stunted growth in children between the ages of 36 to 42 months.,"BACKGROUND The government has made provisions to improve the nutrition of stunted children under the age of five nationally by providing iron folic acid (IFA) tablet since conception. However, these drugs were not able to reduce the incidence of stunted growth. The aim of this study is to assess the effect of moringa intervention during pregnancy on the incidence of stunted growth in children between the ages of 36 to 42 months. DESIGN AND METHODS This study is a follow-up to an experimental RCT-DB study during pregnancy. The interventions given were PG (Moringa Flour), EG (Moringa Extract) and IG (IFA) which was used as control. RESULTS The highest number of children that had stunted growth after taking the PG by IG and EG extracts were 66 (41.5%), 53 (33.3%) and 40 (25.2%), respectively. The stunted risk factor analysis did not show a significant relationship to the stunted incidence. Furthermore, the consumption and dietary patterns of children were based on only fat consumption which was associated with stunted incidence (p<0.05). The results of multivariate analysis showed that the EG extract was effective in reducing the incidence of stunted growth (p<0.005) and as a protective factor of 0.431 times the incidence of stunted growth (LL-UL=0.246-0.754). CONCLUSIONS The administration of Moringa oleifera extract during pregnancy prevents the incidence of stunted growth in children.",2021,"The results of multivariate analysis showed that the EG extract was effective in reducing the incidence of stunted growth (p<0.005) and as a protective factor of 0.431 times the incidence of stunted growth (LL-UL=0.246-0.754). ","['children', 'children between the ages of 36 to 42 months']",['moringa intervention'],['incidence of stunted growth'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0969724', 'cui_str': 'Moringa'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]",,0.0550767,"The results of multivariate analysis showed that the EG extract was effective in reducing the incidence of stunted growth (p<0.005) and as a protective factor of 0.431 times the incidence of stunted growth (LL-UL=0.246-0.754). ","[{'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Basri', 'Affiliation': 'Departement of Nutrition Science, School of Public Health, Hasanuddin University, Makassar. hasanbasri.phunhas@gmail.com.'}, {'ForeName': 'Veni', 'Initials': 'V', 'LastName': 'Hadju', 'Affiliation': 'Departement of Nutrition Science, School of Public Health, Hasanuddin University, Makassar. hasanbasri.phunhas@gmail.com.'}, {'ForeName': 'Andi', 'Initials': 'A', 'LastName': 'Zulkifli', 'Affiliation': 'Departement of Epidemiology, School of Publlic Health, Hasanuddin University, Makassar. hasanbasri.phunhas@gmail.com.'}, {'ForeName': 'Aminuddin', 'Initials': 'A', 'LastName': 'Syam', 'Affiliation': 'Departement of Nutrition Science, School of Public Health, Hasanuddin University, Makassar. hasanbasri.phunhas@gmail.com.'}, {'ForeName': 'Rahayu', 'Initials': 'R', 'LastName': 'Indriasari', 'Affiliation': 'Department of Nutrition Science, School of Public Health, Hasanuddin University, Makassar. hasanbasri.phunhas@gmail.com.'}]",Journal of public health research,['10.4081/jphr.2021.2207'] 3853,33855391,Nurses' team communication in hospitals: A quasi-experimental study using a modified TeamSTEPPS.,"BACKGROUND Communication is a bridge of transaction between the health team, patients, and families that applies in the service units of hospitals, which are closely related to the patient safety culture. TeamSTEPPS is a team strategies and tools to enhance performance and patient safety. Therefore, this study aims to analyze the effect of modified TeamSTEPPS training on the team communication of nurses in hospitals. DESIGN AND METHODS This study used a quasi-experimental pre-posttest control group design and a purposive sampling technique. RESULTS About 28 nurses participated and were distributed into control and intervention groups. The results of the Wilcoxon test on communication perception obtained a p-value greater than α (0.980>0.050), while on communication attitudes the p-value was greater than α (0.517>0.050). Furthermore, the spearman rho test showed that there was no difference between the team perception (p=0.624; α=0.050) and communication attitudes (p = 0.320; α = 0.050). This means that the implementation of this training towards nurses' Team communication in the hospital did not have a significant effect. CONCLUSIONS Hospitals need to carry out the implementation of TeamSTEPPS in a sustainable manner and develop good teamwork and effective team communication.",2021,"Furthermore, the spearman rho test showed that there was no difference between the team perception (p=0.624; α=0.050) and communication attitudes (p = 0.320; α = 0.050).","['28 nurses participated and were distributed into control and intervention groups', ""Nurses' team communication in hospitals"", 'nurses in hospitals']","['TeamSTEPPS', 'modified TeamSTEPPS training']","['communication perception', 'communication attitudes', 'team perception']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",28.0,0.0310269,"Furthermore, the spearman rho test showed that there was no difference between the team perception (p=0.624; α=0.050) and communication attitudes (p = 0.320; α = 0.050).","[{'ForeName': 'Ahsan', 'Initials': 'A', 'LastName': 'Ahsan', 'Affiliation': 'School of Nursing, Faculty of Medicine, Universitas Brawijaya, Malang. ahsanpsik.fk@ub.ac.id.'}, {'ForeName': 'Lucky', 'Initials': 'L', 'LastName': 'Setiowati', 'Affiliation': 'School of Nursing, Faculty of Medicine, Universitas Brawijaya, Malang. ahsanpsik.fk@ub.ac.id.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Wieke Noviyanti', 'Affiliation': 'School of Nursing, Faculty of Medicine, Universitas Brawijaya, Malang. ahsanpsik.fk@ub.ac.id.'}, {'ForeName': 'Ike Nesdia', 'Initials': 'IN', 'LastName': 'Rahmawati', 'Affiliation': 'School of Nursing, Faculty of Medicine, Universitas Brawijaya, Malang. ahsanpsik.fk@ub.ac.id.'}, {'ForeName': 'Evi Harwiati', 'Initials': 'EH', 'LastName': 'Ningrum', 'Affiliation': 'School of Nursing, Faculty of Medicine, Universitas Brawijaya, Malang. ahsanpsik.fk@ub.ac.id.'}, {'ForeName': 'Kuswantoro Rusca', 'Initials': 'KR', 'LastName': 'Putra', 'Affiliation': 'School of Nursing, Faculty of Medicine, Universitas Brawijaya, Malang. ahsanpsik.fk@ub.ac.id.'}]",Journal of public health research,['10.4081/jphr.2021.2157'] 3854,33855243,Loss-related mental states impair executive functions in a context of sadness.,"Stress and anxiety have been shown to temporally impair executive functions, but the role of other emotions, such as sadness, has been inconclusive. Moreover, the role of affect regulation in this relationship has not been extensively studied. The present research investigated whether certain types of mental states (mental output resulting from the use of affect regulation within a specific context or with respect to a specific material or theme) relative to the context of loss would predict impairment of executive functions. Participants were randomly assigned to read either a loss-related newspaper article inducing sadness or a neutral newspaper article. Results showed that low mental states relative to loss (maladaptive affect regulation) predicted impairment of executive functions following an induction of sadness, but not following the neutral induction. Conversely, high mental states (adaptive affect regulation) were not predictive of impairment of executive functions in both the sadness and neutral condition. These findings have implications for the boundaries within which emotion can disrupt high-order cognitive processes.",2021,"Conversely, high mental states (adaptive affect regulation) were not predictive of impairment of executive functions in both the sadness and neutral condition.",[],['loss-related newspaper article inducing sadness or a neutral newspaper article'],['low mental states relative to loss (maladaptive affect regulation) predicted impairment of executive functions'],[],"[{'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0282473', 'cui_str': 'Newspaper Article'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C3536794', 'cui_str': 'Unhappiness'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",,0.0174875,"Conversely, high mental states (adaptive affect regulation) were not predictive of impairment of executive functions in both the sadness and neutral condition.","[{'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'Beaulieu-Pelletier', 'Affiliation': 'Department of Psychology, University of Quebec, Montreal, Quebec, Canada.'}, {'ForeName': 'Marc-André', 'Initials': 'MA', 'LastName': 'Bouchard', 'Affiliation': 'Department of Psychology, University of Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Frederick L', 'Initials': 'FL', 'LastName': 'Philippe', 'Affiliation': 'Department of Psychology, University of Quebec, Montreal, Quebec, Canada.'}]",Heliyon,['10.1016/j.heliyon.2021.e06599'] 3855,33855232,"Corrigendum to ""Investigating the effect of meditation on spiritual wellbeing of Type-2 diabetic amputees: A clinical trial study"" [Heliyon 6 (11) (November 2020) e05567].",[This corrects the article DOI: 10.1016/j.heliyon.2020.e05567.].,2021,[This corrects the article DOI: 10.1016/j.heliyon.2020.e05567.].,['Type-2 diabetic amputees'],['meditation'],[],"[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0002695', 'cui_str': 'Amputee'}]",[],[],,0.0913394,[This corrects the article DOI: 10.1016/j.heliyon.2020.e05567.].,"[{'ForeName': 'Ali Heydari', 'Initials': 'AH', 'LastName': 'Movahed', 'Affiliation': 'Student Research Committee, School of Public Health, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Fakhri', 'Initials': 'F', 'LastName': 'Sabouhi', 'Affiliation': 'Nursing and Midwifery Care Research Center, Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Mohammadpourhodki', 'Affiliation': 'Kashmar Center of Higher Health Education, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Mahdavi', 'Affiliation': 'Department of Epidemiology, School of Public Health, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Goudarzian', 'Affiliation': 'Goldis Hospital, Shahinshahr, Isfahan, Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Amerian', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Mohtashami', 'Affiliation': 'Department of Anesthesiology, School of Allied Medicine, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Mansoure', 'Initials': 'M', 'LastName': 'Kheiri', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Imeni', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Shahroud University of Medical Sciences, Shahroud, Iran.'}]",Heliyon,['10.1016/j.heliyon.2021.e06508'] 3856,33855222,"Efficacy and safety of teneligliptin added to metformin in Chinese patients with type 2 diabetes mellitus inadequately controlled with metformin: A phase 3, randomized, double-blind, placebo-controlled study.","Introduction We evaluated the efficacy and safety of teneligliptin compared with placebo when added to metformin therapy in Chinese patients with type 2 diabetes inadequately controlled with metformin monotherapy. Methods This multicentre, randomized, double-blind, placebo-controlled, parallel-group study enrolled type 2 diabetes patients with glycosylated haemoglobin (HbA1c) 7.0%-<10.0% and fasting plasma glucose (FPG) <270 mg/dl, receiving a stable metformin dose ≥1000 mg/day. Teneligliptin 20 mg or placebo was administered orally once daily (qd) before breakfast for 24 weeks. The primary efficacy end-point was change in HbA1c from baseline to Week 24. Safety end-points included the incidence of adverse events (AEs). Results The least square mean (LSM) change from baseline (standard error [SE]) was -0.72 (0.07) (95% confidence intervals [CI], -0.87, -0.58) for teneligliptin and -0.01 (0.07) (95% CI, -0.16, 0.13) for placebo. The differences (LSM ± SE) between the placebo and teneligliptin groups in HbA1c and FPG were -0.71% ± 0.11% ( p  < .0001) and -16.5 ± 4.7 mg/dl ( p  = .0005), respectively. Teneligliptin yielded significant changes in HbA1c (-0.81%; p  < .0001) and FPG (-22.2 mg/dl; p  < .0001) at Week 12. At Week 24, more patients achieved HbA1c <7.0% with teneligliptin (41.7%) compared with placebo (16.1%; p  < .0001). Treatment-emergent AE incidence was similar with teneligliptin (58.9%) and placebo (68.3%); upper respiratory tract infection, hyperuricaemia and hyperlipidaemia were the most common AEs. Conclusions Teneligliptin 20 mg qd for 24 weeks added to ongoing metformin treatment significantly decreased HbA1c and FPG levels compared with placebo in Chinese type 2 diabetes patients. The combination was safe and tolerable.",2021,Teneligliptin yielded significant changes in HbA1c (-0.81%; p  < .0001) and FPG (-22.2 mg/dl; p  < .0001) at Week 12.,"['Chinese patients with type 2 diabetes mellitus inadequately controlled with', 'parallel-group study enrolled type 2 diabetes patients with glycosylated haemoglobin', 'Chinese patients with type 2 diabetes inadequately controlled with metformin monotherapy', 'Chinese type 2 diabetes patients']","['metformin therapy', 'stable metformin', 'teneligliptin', 'Teneligliptin', 'metformin', 'placebo', 'teneligliptin added to metformin', 'Teneligliptin 20\xa0mg or placebo']","['incidence of adverse events (AEs', 'fasting plasma glucose (FPG', 'FPG', 'efficacy and safety', 'HbA1c and FPG levels', 'least square mean (LSM) change', 'upper respiratory tract infection, hyperuricaemia and hyperlipidaemia', 'Efficacy and safety', 'HbA1c']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0740394', 'cui_str': 'Hyperuricemia'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}]",,0.532489,Teneligliptin yielded significant changes in HbA1c (-0.81%; p  < .0001) and FPG (-22.2 mg/dl; p  < .0001) at Week 12.,"[{'ForeName': 'Linong', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': ""Peking University People's Hospital Beijing China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Shengjing Hospital of China Medical University Liaoning China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Nanjing First Hospital Nanjing Jiangsu China.'}, {'ForeName': 'Xuefeng', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Shiyan Taihe Hospital Hubei China.'}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""Inner Mongolia People's Hospital Inner Mongolia China.""}, {'ForeName': 'Bangzhu', 'Initials': 'B', 'LastName': 'Meng', 'Affiliation': 'The Affiliated Hospital of Inner Mongolia University for Nationalities Inner Mongolia China.'}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': ""Huai'an First People's Hospital Nanjing Medical University Nanjing Jiangsu China.""}, {'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Huadong Hospital Affiliated to Fudan University Shanghai China.'}, {'ForeName': 'Yanmei', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Yancheng City No.1 People's Hospital Jiangsu China.""}, {'ForeName': 'Gen', 'Initials': 'G', 'LastName': 'Takayanagi', 'Affiliation': 'Mitsubishi Tanabe Pharma Development America, Inc. Jersey City NJ USA.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Mitsubishi Tanabe Pharma Development (Beijing) Co., Ltd. Beijing China.'}]","Endocrinology, diabetes & metabolism",['10.1002/edm2.222'] 3857,33855218,"Tolerability of eptinezumab in overweight, obese or type 1 diabetes patients.","Introduction In addition to its role in the pathogenesis of migraine, calcitonin gene-related peptide (CGRP) is implicated in the regulation of insulin secretion. However, there are limited data on the use of CGRP inhibitor monoclonal antibodies in individuals who are overweight/obese and those with diabetes. Methods Two randomized, double-blind, placebo-controlled trials were conducted to assess the safety and metabolic effects of eptinezumab in non-migraine overweight/obese patients (study 1) and patients with type 1 diabetes (T1D; study 2). The primary end-point in overweight/obese patients was safety and changes in basal metabolic rate (BMR), defined as the energy expenditure during the fasting and resting states. In patients with T1D, the primary end-points were safety and insulin sensitivity as assessed by the bodyweight and insulin concentration corrected glucose infusion rate (M/I). Results A total of 24 patients were enrolled in study 1, and 21 patients were enrolled in study 2. In overweight/obese patients, there was no significant difference in the least squares (LS) mean change in BMR between the eptinezumab- and placebo-treated patients from baseline to day 7 (6.4 vs -25.2 Kcal/day; LS mean difference 31.6 [95% confidence interval -90.6, 153.8]). In patients with T1D, there was no significant difference in insulin sensitivity between the eptinezumab and placebo groups. Eptinezumab was well tolerated in both studies with a similar rate of adverse events between treatment groups, and no new safety signals were identified. Conclusion Eptinezumab was well tolerated and not associated with adverse metabolic effects in patients who were overweight/obese or had T1D, providing ongoing support for the use of eptinezumab in these subgroups of patients with migraine.",2021,"In patients with T1D, there was no significant difference in insulin sensitivity between the eptinezumab and placebo groups.","['patients who were overweight/obese or had T1D', 'individuals who are overweight/obese and those with diabetes', 'non-migraine overweight/obese patients (study 1) and patients with type 1 diabetes (T1D; study 2', 'overweight, obese or type 1 diabetes patients', 'A total of 24 patients were enrolled in study 1, and 21 patients were enrolled in study 2']","['CGRP inhibitor monoclonal antibodies', 'placebo', 'eptinezumab', 'Eptinezumab']","['adverse metabolic effects', 'Tolerability', 'bodyweight and insulin concentration corrected glucose infusion rate (M/I', 'safety and metabolic effects', 'least squares (LS) mean change in BMR', 'insulin sensitivity', 'safety and insulin sensitivity', 'safety and changes in basal metabolic rate (BMR), defined as the energy expenditure during the fasting and resting states']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0006669', 'cui_str': 'Calcitonin gene-related peptide'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4694272', 'cui_str': 'eptinezumab'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0542499', 'cui_str': 'Measurement of basal metabolic rate'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}]",24.0,0.388552,"In patients with T1D, there was no significant difference in insulin sensitivity between the eptinezumab and placebo groups.","[{'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Baker', 'Affiliation': 'Lundbeck Seattle BioPharmaceuticals, Inc. Bothell WA USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Schaeffler', 'Affiliation': 'Lundbeck Seattle BioPharmaceuticals, Inc. Bothell WA USA.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Hirman', 'Affiliation': 'Pacific Northwest Statistical Consulting Woodinville WA USA.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Hompesch', 'Affiliation': 'ProSciento, Inc. Chula Vista CA USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Pederson', 'Affiliation': 'Lundbeck Seattle BioPharmaceuticals, Inc. Bothell WA USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Alder BioPharmaceuticals, Inc. (now known as Lundbeck Seattle BioPharmaceuticals, Inc.) Bothell WA USA.'}]","Endocrinology, diabetes & metabolism",['10.1002/edm2.217'] 3858,33855215,Changes in the lipidome in type 1 diabetes following low carbohydrate diet: Post-hoc analysis of a randomized crossover trial.,"Aims Lipid metabolism might be compromised in type 1 diabetes, and the understanding of lipid physiology is critically important. This study aimed to compare the change in plasma lipid concentrations during carbohydrate dietary changes in individuals with type 1 diabetes and identify links to early-stage dyslipidaemia. We hypothesized that (1) the lipidomic profiles after ingesting low or high carbohydrate diet for 12 weeks would be different; and (2) specific annotated lipid species could have significant associations with metabolic outcomes. Methods Ten adults with type 1 diabetes (mean ± SD: age 43.6 ± 13.8 years, diabetes duration 24.5 ± 13.4 years, BMI 24.9 ± 2.1 kg/m 2 , HbA 1c 57.6 ± 2.6 mmol/mol) using insulin pumps participated in a randomized 2-period crossover study with a 12-week intervention period of low carbohydrate diet (< 100 g carbohydrates/day) or high carbohydrate diet (> 250 g carbohydrates/day), respectively, separated by a 12-week washout period. A large-scale non-targeted lipidomics was performed with mass spectrometry in fasting plasma samples obtained before and after each diet intervention. Longitudinal lipid levels were analysed using linear mixed-effects models. Results In total, 289 lipid species were identified from 14 major lipid classes. Comparing the two diets, 11 lipid species belonging to sphingomyelins, phosphatidylcholines and LPC(O-16:0) were changed. All the 11 lipid species were significantly elevated during low carbohydrate diet. Two lipid species were most differentiated between diets, namely SM(d36:1) (β ± SE: 1.44 ± 0.28, FDR  = 0.010) and PC(P-36:4)/PC(O-36:5) (β ± SE: 1.34 ± 0.25, FDR  = 0.009) species. Polyunsaturated PC(35:4) was inversely associated with BMI and positively associated with HDL cholesterol (p < .001). Conclusion Lipidome-wide outcome analysis of a randomized crossover trial of individuals with type 1 diabetes following a low carbohydrate diet showed an increase in sphingomyelins and phosphatidylcholines which are thought to reduce dyslipidaemia. The polyunsaturated phosphatidylcholine 35:4 was inversely associated with BMI and positively associated with HDL cholesterol (p < .001). Results from this study warrant for more investigation on the long-term effect of single lipid species in type 1 diabetes.",2021,The polyunsaturated phosphatidylcholine 35:4 was inversely associated with BMI and positively associated with HDL cholesterol (p < .001).,"['individuals with type 1 diabetes', 'adults with type 1 diabetes', 'individuals with type 1 diabetes and identify links to early-stage dyslipidaemia', 'diabetes duration 24.5\xa0±\xa013.4\xa0years, BMI 24.9\xa0±\xa02.1\xa0kg/m 2 ']","['Polyunsaturated PC(35:4', 'polyunsaturated phosphatidylcholine', 'low carbohydrate diet', 'low carbohydrate diet (< 100\xa0g carbohydrates/day) or high carbohydrate diet']","['dyslipidaemia', 'HDL cholesterol', 'BMI', 'plasma lipid concentrations', 'Longitudinal lipid levels']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4517558', 'cui_str': '13.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4068876', 'cui_str': '2.1'}]","[{'cui': 'C1959616', 'cui_str': 'Lecithin'}, {'cui': 'C0259836', 'cui_str': 'Carbohydrate restricted diet'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0259835', 'cui_str': 'High carbohydrate diet'}]","[{'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}]",10.0,0.0585074,The polyunsaturated phosphatidylcholine 35:4 was inversely associated with BMI and positively associated with HDL cholesterol (p < .001).,"[{'ForeName': 'Naba', 'Initials': 'N', 'LastName': 'Al-Sari', 'Affiliation': 'Steno Diabetes Center Copenhagen Gentofte Denmark.'}, {'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': 'Steno Diabetes Center Copenhagen Gentofte Denmark.'}, {'ForeName': 'Tommi', 'Initials': 'T', 'LastName': 'Suvitaival', 'Affiliation': 'Steno Diabetes Center Copenhagen Gentofte Denmark.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Steno Diabetes Center Copenhagen Gentofte Denmark.'}, {'ForeName': 'Kajetan', 'Initials': 'K', 'LastName': 'Trošt', 'Affiliation': 'Steno Diabetes Center Copenhagen Gentofte Denmark.'}, {'ForeName': 'Ajenthen G', 'Initials': 'AG', 'LastName': 'Ranjan', 'Affiliation': 'Steno Diabetes Center Copenhagen Gentofte Denmark.'}, {'ForeName': 'Merete B', 'Initials': 'MB', 'LastName': 'Christensen', 'Affiliation': 'Steno Diabetes Center Copenhagen Gentofte Denmark.'}, {'ForeName': 'Anne J', 'Initials': 'AJ', 'LastName': 'Overgaard', 'Affiliation': 'Steno Diabetes Center Copenhagen Gentofte Denmark.'}, {'ForeName': 'Flemming', 'Initials': 'F', 'LastName': 'Pociot', 'Affiliation': 'Steno Diabetes Center Copenhagen Gentofte Denmark.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Nørgaard', 'Affiliation': 'Steno Diabetes Center Copenhagen Gentofte Denmark.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Legido-Quigley', 'Affiliation': 'Steno Diabetes Center Copenhagen Gentofte Denmark.'}]","Endocrinology, diabetes & metabolism",['10.1002/edm2.213'] 3859,33855207,Is the stepping-down approach a better option than multiple daily injections in obese patients with poorly controlled Type 2 diabetes on advanced insulin therapy?,"Aim To determine whether de-escalating from advanced insulin therapy (AIT) to the combined use of metformin, an SGLT2 inhibitor, a GLP1 receptor agonist and basal insulin is the better option than multiple daily insulin injections (MDI) in obese patients with poorly controlled T2DM. Methods This was a 16-week, prospective, randomized, controlled trial. Twenty-two obese patients with T2DM on AIT were randomized to intervention (step-down) or control (MDI) group. In the intervention group, all prandial insulin injections were discontinued, but the patient remained on basal insulin and metformin, to which an SGLT2i and a GLP1 RA were added. In the control group, the patient remained on MDI. Results Compared to control group ( n  = 8), A1c was significantly lower at week 4 (9.54% vs 8.25%; p  = .0088) and week 16 (9.7% vs 7.31%; p  < .001) in intervention group ( n  = 10). In intervention group, compared to baseline, there was a significant decrease in weight (-16.38 pounds; p  = .003), BMI (-3.06; p  < .001), LDL cholesterol (-15.7 mg/dl; p  = .0378), total cholesterol (-18.5 mg/dl; p  = .0386), total daily insulin dose (-57.3 units; p  < .001) and a significant improvement in DM-SAT patient satisfaction 0-100 scores: total score (+45.3; p  < .001) and subscale scores (Convenience + 35.28, p  = .019; Lifestyle + 35.8, p  = .0052; Medical control + 51.3, p  < .001; Wellbeing + 47.2, p  = .0091) at week 16. Conclusion De-escalating from AIT to the combined use of metformin, SGLT2i, GLP1 RA and basal insulin in obese patients with poorly controlled T2DM on MDI resulted in significant improvement in glycaemic control, weight loss and significantly higher patient satisfaction. This stepping-down approach may be the better option than continuing MDI in these patients.",2021,"p  < .001) and a significant improvement in DM-SAT patient satisfaction 0-100 scores: total score (+45.3; p  < .001) and subscale scores (Convenience + 35.28, p  = .019;","['obese patients with poorly controlled T2DM', 'obese patients with poorly controlled Type 2 diabetes on advanced insulin therapy', 'Twenty-two obese patients with T2DM on AIT', 'obese patients']","['metformin', 'intervention (step-down) or control (MDI', 'advanced insulin therapy (AIT']","['glycaemic control, weight loss', 'BMI', 'total cholesterol', 'weight', 'LDL cholesterol', 'DM-SAT patient satisfaction 0-100 scores: total score', 'subscale scores']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4284772', 'cui_str': '22'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}]",22.0,0.0404628,"p  < .001) and a significant improvement in DM-SAT patient satisfaction 0-100 scores: total score (+45.3; p  < .001) and subscale scores (Convenience + 35.28, p  = .019;","[{'ForeName': 'Soe', 'Initials': 'S', 'LastName': 'Naing', 'Affiliation': 'Division of Endocrinology University of California San Francisco, Fresno Medical Education Program Fresno CA USA.'}, {'ForeName': 'Geeta', 'Initials': 'G', 'LastName': 'Ramesh', 'Affiliation': 'Department of Family & Community Medicine University of California San Francisco, Fresno Medical Education Program Fresno CA USA.'}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Garcha', 'Affiliation': 'Department of Family & Community Medicine University of California San Francisco, Fresno Medical Education Program Fresno CA USA.'}, {'ForeName': 'Anupama', 'Initials': 'A', 'LastName': 'Poliyedath', 'Affiliation': 'Department of Internal Medicine St Agnes Internal Medicine Residency Program Fresno CA USA.'}, {'ForeName': 'Stutee', 'Initials': 'S', 'LastName': 'Khandelwal', 'Affiliation': 'Department of Internal Medicine University of California San Francisco, Fresno Medical Education Program Fresno CA USA.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Mills', 'Affiliation': 'Department of Internal Medicine University of California San Francisco, Fresno Medical Education Program Fresno CA USA.'}]","Endocrinology, diabetes & metabolism",['10.1002/edm2.204'] 3860,33855195,Effect of 12-week continuous positive airway pressure therapy on glucose levels assessed by continuous glucose monitoring in people with type 2 diabetes and obstructive sleep apnoea; a randomized controlled trial.,"Aim Obstructive sleep apnoea (OSA) is frequent in type 2 diabetes (T2D). The aim was to investigate the effect of a 12-week treatment with continuous positive airway pressure (CPAP) on glycaemic control assessed by continuous glucose monitoring (CGM), HbA1c and fasting blood glucose in patients with T2D and newly detected OSA. Methods In a randomized controlled multicentre study, 72 participants with T2D and moderate to severe OSA (78% male, age 62 ± 7, AHI 35 ± 15) were recruited from outpatient clinics in three Danish hospitals and were randomized to CPAP intervention or control. The main outcome was glycaemic control assessed by 6 days CGM at baseline and after 12-week therapy, as well as by HbA1c and fasting blood glucose. Results No significant changes were found in average glucose levels, time in glucose range, time with hypoglycaemia, time with hyperglycaemia or coefficient of variability. HbA1c decreased 0.7 mmol/mol (0.07%; P  = .8) in the CPAP group and increased 0.8 mmol/mol (0.08%; P  = .6) in the control group (intergroup difference, P  = .6). Fasting blood glucose increased by 0.2 mmol/L ( P  = .02) in the CPAP group and by 0.4 mmol/L ( P  = .01) in the control group (intergroup difference, P  = .7). In a prespecified subgroup analysis comparing participants with high adherence (minimum usage of four hours/night for 70% of all nights) to CPAP to the control group, no significant changes were observed either, although these participants had a tendency towards better glycaemic indices. Conclusions CPAP treatment for 12 weeks does not significantly change glycaemic control in patients with type 2 diabetes and OSA.",2021,"Fasting blood glucose increased by 0.2 mmol/L ( P  = .02) in the CPAP group and by 0.4 mmol/L ( P  = .01) in the control group (intergroup difference, P  = .7).","['patients with T2D and newly detected OSA.\nMethods', 'patients with type 2 diabetes and OSA', 'people with type 2 diabetes and obstructive sleep apnoea', '72 participants with T2D and moderate to severe OSA (78% male, age 62\xa0±\xa07, AHI 35\xa0±\xa015) were recruited from outpatient clinics in three Danish hospitals']","['continuous glucose monitoring (CGM), HbA1c and fasting blood glucose', 'CPAP intervention or control', 'continuous positive airway pressure (CPAP', 'continuous positive airway pressure therapy']","['average glucose levels, time in glucose range, time with hypoglycaemia, time with hyperglycaemia or coefficient of variability', 'glycaemic indices', 'Fasting blood glucose', 'HbA1c and fasting blood glucose', 'Obstructive sleep apnoea (OSA', 'change glycaemic control', 'glycaemic control assessed by 6\xa0days CGM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]",72.0,0.0302107,"Fasting blood glucose increased by 0.2 mmol/L ( P  = .02) in the CPAP group and by 0.4 mmol/L ( P  = .01) in the control group (intergroup difference, P  = .7).","[{'ForeName': 'Anne Margareta', 'Initials': 'AM', 'LastName': 'Banghøj', 'Affiliation': 'Department of Endocrinology and Nephrology Nordsjællands Hospital Hillerød Denmark.'}, {'ForeName': 'Christoffer', 'Initials': 'C', 'LastName': 'Krogager', 'Affiliation': 'Department of Clinical Medicine Aarhus University Aarhus Denmark.'}, {'ForeName': 'Peter Lommer', 'Initials': 'PL', 'LastName': 'Kristensen', 'Affiliation': 'Department of Endocrinology and Nephrology Nordsjællands Hospital Hillerød Denmark.'}, {'ForeName': 'Klavs Würgler', 'Initials': 'KW', 'LastName': 'Hansen', 'Affiliation': 'Diagnostic Centre Regional Hospital Silkeborg Denmark.'}, {'ForeName': 'Esben', 'Initials': 'E', 'LastName': 'Laugesen', 'Affiliation': 'Department of Endocrinology and Internal Medicine Aarhus University Hospital Aarhus Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Fleischer', 'Affiliation': 'Steno Diabetes Center Aarhus Aarhus Denmark.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Lebech Cichosz', 'Affiliation': 'Department of Health Science and Technology Aalborg University Aalborg Denmark.'}, {'ForeName': 'Per Løgstrup', 'Initials': 'PL', 'LastName': 'Poulsen', 'Affiliation': 'Department of Endocrinology and Internal Medicine Aarhus University Hospital Aarhus Denmark.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Glymer Kirkegaard', 'Affiliation': 'Sleep Disorders Clinic Elective Surgery Centre Regional Hospital Silkeborg Silkeborg Denmark.'}, {'ForeName': 'Birger', 'Initials': 'B', 'LastName': 'Thorsteinsson', 'Affiliation': 'Department of Endocrinology and Nephrology Nordsjællands Hospital Hillerød Denmark.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Tarnow', 'Affiliation': 'Steno Diabetes Center Sjælland Holbæk Denmark.'}]","Endocrinology, diabetes & metabolism",['10.1002/edm2.148'] 3861,33855083,Reinforcement of Self-Regulated Brain Activity in Schizophrenia Patients Undergoing Rehabilitation.,"The experiment was aimed to compare the effects of different forms of rehabilitation applied in patients with schizophrenia. Verification of the obtained results was based on the analysis of the level of cognitive and social functioning of the subjects. For this purpose, the following clinical tools were used: Positive and Negative Syndrome Scale (PANSS), Beck Cognitive Insight Scale (BCIS), Color Trial Test (CTT-1, CTT-2), d2 psychological tests, Acceptance of Illness Scale (AIS), Self-efficacy Scale (GSES), Quantitative Electroencephalogram Biofeedback (QEEG-BF), auditory event-related potentials (ERPs), and serum levels of brain-derived neurotrophic factor (BDNF). The subjects were mentally stable male schizophrenia patients who had been in remission. They were divided into two groups which received different types of rehabilitation for three months. Group 1 patients followed a standard rehabilitation and Group 2 patients received GSR Biofeedback ( galvanic skin response Biofeedback, GSR-BF ) training. Pretherapy and posttherapy measurements were made for each group. Experimental rehabilitation based on GSR-BF training resulted in regulatory control of neurophysiological mechanisms, and the parameters obtained demonstrated improvement in the subjects' cognitive and social function. The following therapy outcomes were observed: (1) reduce psychopathological symptoms (2) improving cognitive (concentration, attention) and social functions (3) increase in the neurotrophic factor BDNF. GSR-BF can be used as an alternative to conventional rehabilitation in schizophrenia patients.",2021,"Experimental rehabilitation based on GSR-BF training resulted in regulatory control of neurophysiological mechanisms, and the parameters obtained demonstrated improvement in the subjects' cognitive and social function.","['schizophrenia patients', 'patients with schizophrenia', 'Schizophrenia Patients Undergoing Rehabilitation', 'subjects were mentally stable male schizophrenia patients who had been in remission']","['GSR-BF training', 'standard rehabilitation', 'GSR Biofeedback ( galvanic skin response Biofeedback, GSR-BF ) training']","[""subjects' cognitive and social function"", 'Positive and Negative Syndrome Scale (PANSS), Beck Cognitive Insight Scale (BCIS), Color Trial Test (CTT-1, CTT-2), d2 psychological tests, Acceptance of Illness Scale (AIS), Self-efficacy Scale (GSES), Quantitative Electroencephalogram Biofeedback (QEEG-BF), auditory event-related potentials (ERPs), and serum levels of brain-derived neurotrophic factor (BDNF', 'psychopathological symptoms (2) improving cognitive (concentration, attention) and social functions (3) increase in the neurotrophic factor BDNF']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]","[{'cui': 'C0016989', 'cui_str': 'Galvanic skin response'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0204622', 'cui_str': 'Biofeedback, galvanic skin response'}]","[{'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0233820', 'cui_str': 'Insight'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0033905', 'cui_str': 'Psychologic test'}, {'cui': 'C0582608', 'cui_str': 'Acceptance of illness scale'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0282171', 'cui_str': 'Event-related potentials'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0027754', 'cui_str': 'Nerve growth factor'}]",,0.0025315,"Experimental rehabilitation based on GSR-BF training resulted in regulatory control of neurophysiological mechanisms, and the parameters obtained demonstrated improvement in the subjects' cognitive and social function.","[{'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Markiewicz', 'Affiliation': 'Psychiatric Nursing Department, Faculty of Health Sciences, Medical University of Lublin, 20-081 Lublin, Poland.'}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Dobrowolska', 'Affiliation': 'Department of Management in Nursing, Faculty of Health Sciences, Medical University of Lublin, 20-081 Lublin, Poland.'}]",BioMed research international,['10.1155/2021/8030485'] 3862,33855080,Implications of Continuous Noninvasive Finger Cuff Arterial Pressure Device Use during Cesarean Delivery for Goal-Directed Fluid Therapy Preload Optimization: A Randomized Controlled Trial.,"Background Although fixed-volume conventional fluid preloading protocol fails to attenuate postspinal hypotension during cesarean delivery, the effect of goal-directed fluid therapy (GDFT) remains less explored. Continuous noninvasive finger cuff arterial pressure monitoring using devices such as the ClearSight System can provide the noninvasive stroke volume value, enabling clinicians to perform GDFT before spinal anesthesia; however, the efficacy of GDFT requires further elucidation. Method In total, 71 consecutive full-term pregnant women were randomly divided into a control group ( n = 34) and a GDFT group ( n = 37). Before spinal anesthesia, the control group received a fixed dose (1000 mL) of crystalloid fluid, but the GDFT group received repeated 3 mL/kg body weight of crystalloid fluid challenges within 3 minutes with a 1-minute interval between each fluid challenge based on the stroke volume incremental changes obtained using the ClearSight System (targeting a stroke volume increase of ≥5% after a fluid challenge). The primary outcome was the incidence of postspinal hypotension. The secondary outcomes were total fluid volume, vasopressor dosage, hemodynamic parameter changes, maternal adverse effects, and neonatal profiles. Result Women in the GDFT group received more fluid than did those in the control group (1132 ± 108 vs. 1247 ± 202 mL; p = 0.0044), but the incidence of postspinal hypotension (79.4% vs. 73.0%,; p = 0.5864) and norepinephrine dose (12.5 ± 10.6 vs. 15.1 ± 12.8 mcg, respectively; p = 0.3512) was comparable between the two groups. Fewer women in the GDFT group experienced nausea (61.76% vs. 35.14%; p = 0.0332). Neonatal outcomes (Apgar score and umbilical blood analysis) were comparable and typical in both groups. Conclusion ClearSight-guided GDFT did not ameliorate postspinal hypotension but may reduce nausea. This trial is registered with NCT03013140.",2021,Fewer women in the GDFT group experienced nausea (61.76% vs. 35.14%; p = 0.0332).,['71 consecutive full-term pregnant women'],"['norepinephrine', 'Continuous Noninvasive Finger Cuff Arterial Pressure Device', 'GDFT']","['nausea', 'Neonatal outcomes (Apgar score and umbilical blood analysis', 'total fluid volume, vasopressor dosage, hemodynamic parameter changes, maternal adverse effects, and neonatal profiles', 'incidence of postspinal hypotension', 'postspinal hypotension']","[{'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0232108', 'cui_str': 'Arterial pulse pressure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0041638', 'cui_str': 'Umbilical structure'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449971', 'cui_str': 'Volume of fluid used'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}]",71.0,0.100302,Fewer women in the GDFT group experienced nausea (61.76% vs. 35.14%; p = 0.0332).,"[{'ForeName': 'Shan-Han', 'Initials': 'SH', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, National Taiwan University Hospital, No. 7, Chung-Shan S. Rd., Taipei, Taiwan.'}, {'ForeName': 'Yi-Shiuan', 'Initials': 'YS', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, Taiwan Adventist Hospital, No. 424, Sec. 2, Bade Rd., Songshan District, Taipei, Taiwan.'}, {'ForeName': 'Chien-Nan', 'Initials': 'CN', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynecology, National Taiwan University Hospital, No. 7, Chung-Shan S. Rd., Taipei, Taiwan.'}, {'ForeName': 'Ya-Jung', 'Initials': 'YJ', 'LastName': 'Cheng', 'Affiliation': 'Department of Anesthesiology, National Taiwan University Hospital, No. 7, Chung-Shan S. Rd., Taipei, Taiwan.'}, {'ForeName': 'Ying-Hsi', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, National Taiwan University Hospital, No. 7, Chung-Shan S. Rd., Taipei, Taiwan.'}, {'ForeName': 'Hsin-Chan', 'Initials': 'HC', 'LastName': 'Chiu', 'Affiliation': 'Department of Anesthesiology, National Taiwan University Hospital, No. 7, Chung-Shan S. Rd., Taipei, Taiwan.'}, {'ForeName': 'Chun-Yu', 'Initials': 'CY', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, National Taiwan University Hospital, No. 7, Chung-Shan S. Rd., Taipei, Taiwan.'}]",BioMed research international,['10.1155/2021/6685584'] 3863,33855002,Comparison of pharmacokinetics and safety characteristics between two olopatadine hydrochloride 5 mg tablet formulations in healthy Korean subjects.,"Histamine acts by binding to four histamine receptors (H1 to H4), of which the H1 is known to participate in dilate blood vessels, bronchoconstriction, and pruritus. Olopatadine hydrochloride blocks the release of histamine from mast cells and it inhibits H1 receptor activation. Olopatadine hydrochloride is anti-allergic agent that is effectively used. The object of this study had conducted to compare the pharmacokinetics (PKs) and safety characteristics between olopatadine hydrochloride 5 mg (test formulation) and olopatadine hydrochloride 5 mg (reference formulation; Alerac ® ) in Korean subjects. This study had conducted an open-label, randomized, fasting condition, single-dose, 2-treatment, 2-period, 2-way crossover. Subjects received single-dosing of reference formulation or test formulation in each period and blood samples were collected over 24 hours after administration for PK analysis. A wash-out period of 7 days was placed between the doses. Plasma concentration of olopatadine were determined using liquid chromatography-tandem spectrometry mass (LC-MS/MS). A total of 32 subjects were enrolled and 28 subjects completed. There were not clinical significantly different in the safety between two treatment groups for 32 subjects who administered the study drug more than once. The geometric mean ratio of test formulation to reference formulation and its 90% confidence intervals for The peak plasma concentration (C max ) and the areas under the plasma concentration-time curve from 0 to the last concentration (AUC last ) were 1.0845 (1.0107-1.1637) and 1.0220 (1.0005-1.0439), respectively. Therefore, the test formulation was bioequivalent in PK characteristics and was equally safe as the reference formulation. Trial Registration Clinical Research Information Service Identifier: KCT0005943.",2021,There were not clinical significantly different in the safety between two treatment groups for 32 subjects who administered the study drug more than once.,"['32 subjects were enrolled and 28 subjects completed', '32 subjects who administered the study drug more than once', 'Korean subjects', 'healthy Korean subjects']","['Histamine', 'olopatadine', 'olopatadine hydrochloride 5 mg (reference formulation', 'olopatadine hydrochloride', 'Alerac ® ', 'Olopatadine hydrochloride']","['Plasma concentration', 'pharmacokinetics (PKs) and safety characteristics', 'geometric mean ratio of test formulation', 'peak plasma concentration (C max ) and the areas under the plasma concentration-time curve']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}]","[{'cui': 'C0019588', 'cui_str': 'Histamine'}, {'cui': 'C0527189', 'cui_str': 'olopatadine'}, {'cui': 'C0771892', 'cui_str': 'Olopatadine hydrochloride'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",32.0,0.018809,There were not clinical significantly different in the safety between two treatment groups for 32 subjects who administered the study drug more than once.,"[{'ForeName': 'Jae Hoon', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Medical Science, College of Medicine, Chungnam National University, Daejeon 34134, Korea.'}, {'ForeName': 'Minyu', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Huons Co., Ltd, Seongnam 13486, Korea.'}, {'ForeName': 'Namsick', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'Huons Co., Ltd, Seongnam 13486, Korea.'}, {'ForeName': 'Tae-Young', 'Initials': 'TY', 'LastName': 'Oh', 'Affiliation': 'Huons Co., Ltd, Seongnam 13486, Korea.'}, {'ForeName': 'Seung-Kwan', 'Initials': 'SK', 'LastName': 'Nam', 'Affiliation': 'Huons Co., Ltd, Seongnam 13486, Korea.'}, {'ForeName': 'Yoon Seok', 'Initials': 'YS', 'LastName': 'Choi', 'Affiliation': 'Huons Co., Ltd, Seongnam 13486, Korea.'}, {'ForeName': 'In Sun', 'Initials': 'IS', 'LastName': 'Kwon', 'Affiliation': 'Clinical Trials Center, Chungnam National University Hospital, Daejeon 35015, Korea.'}, {'ForeName': 'Jin Gyu', 'Initials': 'JG', 'LastName': 'Jung', 'Affiliation': 'Department of Family Medicine, Chungnam National University Hospital, Daejeon 35015, Korea.'}, {'ForeName': 'Jang Hee', 'Initials': 'JH', 'LastName': 'Hong', 'Affiliation': 'Department of Medical Science, College of Medicine, Chungnam National University, Daejeon 34134, Korea.'}]",Translational and clinical pharmacology,['10.12793/tcp.2021.29.e6'] 3864,33855001,Pharmacokinetic comparison between a fixed-dose combination of fimasartan/amlodipine/hydrochlorothiazide 60/10/25 mg and a corresponding loose combination of fimasartan/amlodipine 60/25 mg and hydrochlorothiazide 25 mg in healthy subjects.,"For the treatment of hypertension, fixed-dose combinations (FDCs) of antihypertensive drugs can provide complementary benefits from improved compliance and cost-effectiveness compared with loose combinations of corresponding drugs. A new FDC of fimasartan/amlodipine/hydrochlorothiazide 60/10/25 mg is undergoing clinical development. A randomized, open-label, single-dose, 3-period, 3-sequence, partially replicated crossover phase 1 study was conducted to compare the pharmacokinetics (PKs) between the FDC of fimasartan/amlodipine/hydrochlorothiazide 60/10/25 mg and a loose combination of a dual-combination FDC (fimasartan/amlodipine 60/10 mg) and hydrochlorothiazide 25 mg. Sixty healthy subjects were randomized, and 55 subjects completed the study. Serial blood samples were collected, and plasma concentrations of fimasartan, amlodipine and hydrochlorothiazide were measured to analyze PK parameters. The PK profiles of the FDC were similar to those of the loose combinations. The geometric mean ratios (GMRs) and 90% confidence intervals (CIs) of the FDC to loose combinations for the maximum plasma concentration (C max ) and area under the curve until the last measurable time point (AUC last ) were within the conventional bioequivalent range of 0.80 to 1.25. The GMRs and 90% CIs of fimasartan, amlodipine and hydrochlorothiazide were 1.0163 (0.8681-1.1898), 0.9595 (0.9256-0.9946), and 1.1294 (1.0791-1.1821) for C max and 1.0167 (0.9347-1.1059), 0.9575 (0.9317-0.9841), and 1.0561 (1.0170-1.0967) for AUC last , respectively. Both the FDC and loose combinations were well tolerated. In conclusion, the FDC of fimasartan/amlodipine/hydrochlorothiazide 60/10/25 mg showed similar PK profiles to those of the corresponding loose combination, and both treatments were well tolerated.",2021,The geometric mean ratios (GMRs) and 90% confidence intervals (CIs) of the FDC to loose combinations for the maximum plasma concentration (C max ) and area under the curve until the last measurable time point (AUC last ) were within the conventional bioequivalent range of 0.80 to 1.25.,"['Sixty healthy subjects were randomized, and 55 subjects completed the study', 'healthy subjects']","['fimasartan, amlodipine and hydrochlorothiazide', 'hydrochlorothiazide', 'fimasartan/amlodipine/hydrochlorothiazide', 'FDC (fimasartan/amlodipine', 'fimasartan/amlodipine']","['tolerated', 'geometric mean ratios (GMRs) and 90% confidence intervals (CIs', 'maximum plasma concentration (C max ) and area under the curve until the last measurable time point (AUC last ', 'compliance and cost-effectiveness', 'plasma concentrations of fimasartan, amlodipine and hydrochlorothiazide', 'PK profiles']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C2825622', 'cui_str': 'fimasartan'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}, {'cui': 'C0340427', 'cui_str': 'Primary familial dilated cardiomyopathy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C2825622', 'cui_str': 'fimasartan'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}]",60.0,0.0315747,The geometric mean ratios (GMRs) and 90% confidence intervals (CIs) of the FDC to loose combinations for the maximum plasma concentration (C max ) and area under the curve until the last measurable time point (AUC last ) were within the conventional bioequivalent range of 0.80 to 1.25.,"[{'ForeName': 'Jihyun', 'Initials': 'J', 'LastName': 'Jung', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul 03080, Korea.'}, {'ForeName': 'Soyoung', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul 03080, Korea.'}, {'ForeName': 'Jaeseong', 'Initials': 'J', 'LastName': 'Oh', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul 03080, Korea.'}, {'ForeName': 'SeungHwan', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul 03080, Korea.'}, {'ForeName': 'In-Jin', 'Initials': 'IJ', 'LastName': 'Jang', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul 03080, Korea.'}, {'ForeName': 'Donghwan', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': 'Department of Statistics, Ewha Womans University, Seoul 03760, Korea.'}, {'ForeName': 'Kyung-Sang', 'Initials': 'KS', 'LastName': 'Yu', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul 03080, Korea.'}]",Translational and clinical pharmacology,['10.12793/tcp.2021.29.e5'] 3865,33855000,Comparative pharmacokinetics between tenofovir disoproxil phosphate and tenofovir disoproxil fumarate in healthy subjects.,"Tenofovir is the representative treatment for human immunodeficiency virus and hepatitis B virus infection. This study was conducted to assess the pharmacokinetics (PKs) and safety characteristics after a single administration of tenofovir disoproxil phosphate compared to tenofovir disoproxil fumarate in healthy male subjects. An open-label, randomized, single administration, two-treatment, two-sequence crossover study was conducted in 37 healthy volunteers. Serial blood samples were collected up to 72 hours. Non-compartmental analysis was used to calculate the PK parameters. The 90% confidence intervals (90% CIs) of the geometric mean ratio (GMR) were calculated for comparing tenofovir disoproxil phosphate to tenofovir disoproxil fumarate. Safety assessments were performed including clinical laboratory tests, adverse events, etc. during the study. The GMR and 90% CIs were 1.0514 (0.9527-1.1603) for C max and 1.0375 (0.9516-1.1311) for AUC last , respectively, and both fell within the conventional bioequivalence range of 0.8-1.25. Both tenofovir salt forms were tolerable. This study demonstrated that tenofovir disoproxil phosphate (292 mg) was bioequivalent to tenofovir disoproxil fumarate (300 mg).",2021,The GMR and 90% CIs were 1.0514 (0.9527-1.1603) for C max and 1.0375,"['healthy male subjects', 'healthy subjects', 'human immunodeficiency virus and hepatitis B virus infection', '37 healthy volunteers']","['Tenofovir', 'tenofovir disoproxil fumarate', 'tenofovir disoproxil phosphate to tenofovir disoproxil fumarate', 'tenofovir disoproxil phosphate', 'tenofovir disoproxil phosphate and tenofovir disoproxil fumarate', 'tenofovir salt']","['geometric mean ratio (GMR', 'pharmacokinetics (PKs) and safety characteristics', 'clinical laboratory tests, adverse events, etc']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}]","[{'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0963398', 'cui_str': 'tenofovir disoproxil'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0036140', 'cui_str': 'Salts'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4505474', 'cui_str': 'Clinical Laboratory Tests'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",37.0,0.0331373,The GMR and 90% CIs were 1.0514 (0.9527-1.1603) for C max and 1.0375,"[{'ForeName': 'Sangmi', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul 03080, Korea.'}, {'ForeName': 'Eunwoo', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul 03080, Korea.'}, {'ForeName': 'Seol Ju', 'Initials': 'SJ', 'LastName': 'Moon', 'Affiliation': 'Department of Pharmacology, School of Medicine, Chonbuk National University, Jeonju 54907, Korea.'}, {'ForeName': 'Jina', 'Initials': 'J', 'LastName': 'Jung', 'Affiliation': 'Hanmi Pharmaceutical Company, Seoul 05545, Korea.'}, {'ForeName': 'SeungHwan', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul 03080, Korea.'}, {'ForeName': 'Kyung-Sang', 'Initials': 'KS', 'LastName': 'Yu', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul 03080, Korea.'}]",Translational and clinical pharmacology,['10.12793/tcp.2021.29.e4'] 3866,33854998,Cognitive improvement effect of gintonin might be associated with blood-brain barrier permeability enhancement: dynamic contrast-enhanced MRI pilot study.,"Along with the multiple neuroprotective effect, recent studies suggest that gintonin might increase the blood brain barrier permeability. We evaluated the effect of gintonin on the vascular permeability changes in different brain segments, using dynamic contrast-enhanced (DCE) magnetic resonance imaging (MRI). In this 8-week, randomized, open label pilot study, ten participants with subjective memory impairment but preserved cognitive function assigned to gintonin-enriched fraction (GEF) 300 mg/day or placebo groups. Korean versions of the Alzheimer's disease assessment scale (ADAS-K) and DCE-MRI parameters including K trans and V p in different brain segments were evaluated at baseline and at 8 weeks after treatment. Nine participants completed the study protocol. No adverse events occurred during the observation period for 8 weeks in both groups. Following gintonin administration, increment trends of the brain permeability that did not reach a statistical significance were observed in the left hippocampus (K trans and V p , both, p = 0.062), left thalamus and in left putamen (K trans , p = 0.062), and left insula and right amygdala (V p , p = 0.062), but not in the control placebo group. The increment of the K trans value in the left thalamus from the baseline was highly correlated with the change of the ADAS scores (r = -0.900, p = 0.037). Gintonin might enhance the blood-brain barrier (BBB) permeability in the brain structures involved in cognitive functions. Further efficacy exploration for the synergistic effect of gintonin's BBB permeability enhancement to its other cognitive enhancing mechanisms are warranted. Trial Registration Clinical Research Information Service Identifier: KCT0003418.",2021,"Following gintonin administration, increment trends of the brain permeability that did not reach a statistical significance were observed in the left hippocampus (K trans and V p , both, p = 0.062), left thalamus and in left putamen (K trans , p = 0.062), and left insula and right amygdala (V p , p = 0.062), but not in the control placebo group.",['ten participants with subjective memory impairment but preserved cognitive function assigned to'],"['gintonin-enriched fraction (GEF) 300 mg/day or placebo', 'gintonin', 'dynamic contrast-enhanced (DCE) magnetic resonance imaging (MRI']","['ADAS scores', ""Alzheimer's disease assessment scale (ADAS-K) and DCE-MRI parameters including K trans and V p in different brain segments"", 'left insula and right amygdala', 'adverse events', 'blood brain barrier permeability', 'brain permeability', 'blood-brain barrier (BBB) permeability']","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0233794', 'cui_str': 'Memory impairment'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C4079515', 'cui_str': 'gintonin'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1535597', 'cui_str': 'Truncal vagotomy with pyloroplasty'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005854', 'cui_str': 'Brain-Blood Barrier'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}]",10.0,0.0455841,"Following gintonin administration, increment trends of the brain permeability that did not reach a statistical significance were observed in the left hippocampus (K trans and V p , both, p = 0.062), left thalamus and in left putamen (K trans , p = 0.062), and left insula and right amygdala (V p , p = 0.062), but not in the control placebo group.","[{'ForeName': 'Woo-Jin', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Seoul National University Hospital, Seoul 03080, Korea.'}, {'ForeName': 'Yong-Won', 'Initials': 'YW', 'LastName': 'Shin', 'Affiliation': 'Department of Neurology, Seoul National University Hospital, Seoul 03080, Korea.'}, {'ForeName': 'Hyeyeon', 'Initials': 'H', 'LastName': 'Chang', 'Affiliation': 'National Center for Mental Health, Seoul 04933, Korea.'}, {'ForeName': 'Hye-Rim', 'Initials': 'HR', 'LastName': 'Shin', 'Affiliation': 'Department of Neurology, Dankook University Hospital, Cheonan 31116, Korea.'}, {'ForeName': 'Won-Woo', 'Initials': 'WW', 'LastName': 'Kim', 'Affiliation': 'Gintonin KU Biotech Co., LTD., Anyang 14087, Korea.'}, {'ForeName': 'Seok-Won', 'Initials': 'SW', 'LastName': 'Jung', 'Affiliation': 'Gintonin KU Biotech Co., LTD., Anyang 14087, Korea.'}, {'ForeName': 'Seung-Hong', 'Initials': 'SH', 'LastName': 'Choi', 'Affiliation': 'Department of Radiology, Seoul National University Hospital, Seoul 03080, Korea.'}, {'ForeName': 'Manho', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Seoul National University Hospital, Seoul 03080, Korea.'}, {'ForeName': 'Seung-Yeol', 'Initials': 'SY', 'LastName': 'Nah', 'Affiliation': 'Department of Physiology, College of Veterinary Medicine, Konkuk University, Seoul 05029, Korea.'}]",Translational and clinical pharmacology,['10.12793/tcp.2021.29.e2'] 3867,33854988,A randomized controlled trial to compare the efficacy of regenerated and non-regenerated oxidized cellulose gauze for the secondary treatment of local bleeding in patients undergoing hepatic resection.,"Purpose Oxidized cellulose is available in many forms, but manufactured using either a regenerated or non-regenerated process. In this study, we evaluated the effects of 2 different hemostatic agents for the treatment of local bleeding in patients undergoing hepatic resection. Methods This was a monocentric, parallel-group, randomized, and controlled clinical trial to compare oxidized regenerated cellulose gauze (ORCG) with oxidized non-regenerated cellulose gauze (ONRCG) in patients undergoing hepatectomy. The primary endpoint was the time to hemostasis at the target bleeding site. The secondary endpoints were the postoperative drainage volume on the first 2 days after surgery and the hospital stay. Results There was no significant difference between the ORCG and ONRCG groups in time to hemostasis from column analysis (238.8 ± 121.6 seconds vs. 193.7 ± 85.3 seconds, P = 0.068), and there were no differences in the rates of hemostatic success between the 2 groups at 120 seconds (18.4% vs. 24.3%; odds ratio [OR], 0.703; 95% confidence interval [CI], 0.231-2.136) and 300 seconds (71.1% vs. 89.2%; OR, 0.298; 95% CI, 0.085-1.041). However, the ONRCG group was superior to the ORCG group in hemostasis according to the survival analysis (log-rank test, P = 0.044). Moreover, there were also no significant differences between the 2 groups in postoperative drainage volume on the first 2 days (P = 0.436, P = 0.381) and hospital stay (P = 0.537, P = 0.200). Conclusion ONRCG was not inferior to ORCG as a hemostatic agent in patients undergoing liver resection.",2021,"There was no significant difference between the ORCG and ONRCG groups in time to hemostasis from column analysis (238.8 ± 121.6 seconds vs. 193.7 ± 85.3 seconds, P = 0.068), and there were no differences in the rates of hemostatic success between the 2 groups at 120 seconds (18.4% vs. 24.3%; odds ratio [OR], 0.703; 95% confidence interval [CI], 0.231-2.136) and 300 seconds (71.1% vs. 89.2%; OR, 0.298; 95% CI, 0.085-1.041).","['patients undergoing hepatectomy', 'patients undergoing liver resection', 'patients undergoing hepatic resection']","['oxidized regenerated cellulose gauze (ORCG) with oxidized non-regenerated cellulose gauze (ONRCG', 'regenerated and non-regenerated oxidized cellulose gauze', 'ORCG', 'ONRCG', 'hemostatic agents']","['time to hemostasis at the target bleeding site', 'postoperative drainage volume on the first 2 days after surgery and the hospital stay', 'postoperative drainage volume', 'rates of hemostatic success', 'hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0139977', 'cui_str': 'regenerated cellulose'}, {'cui': 'C0590323', 'cui_str': 'Gauzes'}, {'cui': 'C0007649', 'cui_str': 'oxidized cellulose'}, {'cui': 'C0019120', 'cui_str': 'Hemostatic agent'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",,0.287396,"There was no significant difference between the ORCG and ONRCG groups in time to hemostasis from column analysis (238.8 ± 121.6 seconds vs. 193.7 ± 85.3 seconds, P = 0.068), and there were no differences in the rates of hemostatic success between the 2 groups at 120 seconds (18.4% vs. 24.3%; odds ratio [OR], 0.703; 95% confidence interval [CI], 0.231-2.136) and 300 seconds (71.1% vs. 89.2%; OR, 0.298; 95% CI, 0.085-1.041).","[{'ForeName': 'Chengshuo', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Hepatobiliary Surgery, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Dazhi', 'Initials': 'D', 'LastName': 'Fu', 'Affiliation': 'Department of Hepatobiliary Surgery, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Fengshan', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Hepatobiliary Surgery, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Xinping', 'Initials': 'X', 'LastName': 'Zhong', 'Affiliation': 'Department of Hepatobiliary Surgery, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Hepatobiliary Surgery, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'Department of Hepatobiliary Surgery, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Baifeng', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Hepatobiliary Surgery, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Jialin', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Hepatobiliary Surgery, The First Hospital of China Medical University, Shenyang, China.'}]",Annals of surgical treatment and research,['10.4174/astr.2021.100.4.193'] 3868,33854983,Effects of Infant Formula Supplemented With Prebiotics and OPO on Infancy Fecal Microbiota: A Pilot Randomized Clinical Trial.,"Several lines of evidence suggest that the intestinal microbiota plays crucial roles in infant development, and that it is highly influenced by extrinsic and intrinsic factors. Prebiotic-containing infant formula may increase gastrointestinal tolerance and improve commensal microbiota composition. However, it remains unknown whether supplementation of milk-formulas with prebiotics and 1,3-olein-2-palmitin (OPO) can achieve feeding outcomes similar to those of breastfeeding. In the present study, we investigated the effects of two kinds of infant formula with different additives on the overall diversity and composition of the fecal microbiota, to determine which was closer to breastfeeding. A total of 108 infants were enrolled, including breastfeeding (n=59) and formula feeding group (n=49). The formula feeding infants were prospectively randomly divided into a standard formula group (n=18), and a supplemented formula group(n=31). The fecal samples were collected at 4 months after intervention. Fecal microbiota analysis targeting the V4 region of the 16S rRNA gene was performed using MiSeq sequencing. The overall bacterial diversity and composition, key functional bacteria, and predictive functional profiles in the two different formula groups were compared with breastfeeding group. We found that the alpha diversity of the gut microbiota was not significantly different between the OPO and breastfeeding groups with Chaos 1 index (p=0.346). The relative abundances of Enhydrobacter and Akkermansia in the OPO group were more similar to those of the breastfeeding group than to those of the standard formula group. The gut microbiota metabolism function prediction analysis showed that the supplemented formula group was similar to the breastfeeding group in terms of ureolysis (p=0.297). These findings suggest that, when formula supplemented with prebiotics and OPO was given, the overall bacterial diversity and parts of the composition of the fecal microbiota would be similar to that of breastfeeding infants.",2021,The relative abundances of Enhydrobacter and Akkermansia in the OPO group were more similar to those of the breastfeeding group than to those of the standard formula group.,"['108 infants were enrolled, including breastfeeding (n=59) and formula feeding group (n=49', 'Infancy Fecal Microbiota']","['Prebiotic-containing infant formula', '1,3-olein-2-palmitin (OPO', 'Infant Formula Supplemented With Prebiotics and OPO']","['overall bacterial diversity and composition, key functional bacteria, and predictive functional profiles', 'relative abundances of Enhydrobacter and Akkermansia', 'gastrointestinal tolerance and improve commensal microbiota composition', 'fecal samples', 'alpha diversity of the gut microbiota']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}]","[{'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0150589', 'cui_str': 'Infant formula'}, {'cui': 'C0452742', 'cui_str': 'Formula milk'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C1226941', 'cui_str': 'Genus Enhydrobacter'}, {'cui': 'C1490589', 'cui_str': 'Akkermansia'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0542329', 'cui_str': 'Commensal parasite'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]",108.0,0.0318344,The relative abundances of Enhydrobacter and Akkermansia in the OPO group were more similar to those of the breastfeeding group than to those of the standard formula group.,"[{'ForeName': 'Bingquan', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': ""Department of Child Health Care, Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China.""}, {'ForeName': 'Shuangshuang', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': ""Department of Child Health Care, Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China.""}, {'ForeName': 'Kexin', 'Initials': 'K', 'LastName': 'Lin', 'Affiliation': ""Department of Child Health Care, Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""Department of Child Health Care, Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China.""}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Lv', 'Affiliation': ""Department of Child Health Care, Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China.""}, {'ForeName': 'Zhengyan', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': ""Department of Child Health Care, Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Shao', 'Affiliation': ""Department of Child Health Care, Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China.""}]",Frontiers in cellular and infection microbiology,['10.3389/fcimb.2021.650407'] 3869,33854934,Investigation the effect of jujube seed capsule on sleep quality of postmenopausal women: A double-blind randomized clinical trial.,"Bakground and objective Sleep disorder is among the most common problems in the life of postmenopausal women. Because of the complications of chemical drugs, many women prefer to use herbal supplements for relieving sleep problems. So, the main objective of this study was to determine the effect of the jujube seed capsule on sleep quality in postmenopausal women. Materials and methods This study was a double-blind clinical trial conducted on 106 postmenopausal women in Khuzestan province, southwest of Iran. All participants were selected by a simple non-probability sampling method. Data were collected through a demographic data form and the Pittsburgh sleeps quality index (PSQI). Individuals were randomly divided into intervention ( n = 53) and control ( n = 53) groups. The intervention group received 250 mg oral jujube seed capsule and the control group received a placebo capsule twice a day for 21 days. After the treatment, the PSQI was completed in both intervention and control groups. Data were analyzed using the independent t-test and the Chi-square test using SPSS software version 24, and p -value < 0.05 was considered as the significance level. Results The results revealed that after treatment, the mean scores of sleep quality decreased in the intervention and control group. Although this difference was statistically significant in both intervention and control groups ( p -value < 0.05), more reduction observed in the intervention group ( p -value < 0.001). Conclusion Consumption of the jujube seed capsule had a positive impact on improving the sleep quality of postmenopausal women and could be recommended as a useful herbal medication.",2020,"Although this difference was statistically significant in both intervention and control groups ( p -value < 0.05), more reduction observed in the intervention group ( p -value < 0.001). ","['106 postmenopausal women in Khuzestan province, southwest of Iran', 'postmenopausal women']","['jujube seed capsule', '250 mg oral jujube seed capsule and the control group received a placebo capsule', 'herbal supplements']","['sleep quality', 'mean scores of sleep quality']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0873120', 'cui_str': 'Jujube seed extract'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1504473', 'cui_str': 'Herbal Supplements'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",106.0,0.12118,"Although this difference was statistically significant in both intervention and control groups ( p -value < 0.05), more reduction observed in the intervention group ( p -value < 0.001). ","[{'ForeName': 'Razieh', 'Initials': 'R', 'LastName': 'Mahmoudi', 'Affiliation': 'Department of Midwifery, Faculty of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Ansari', 'Affiliation': 'Menopause Andropause Research Center, Department of Midwifery, Faculty of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mohammad Hosein', 'Initials': 'MH', 'LastName': 'Haghighizadeh', 'Affiliation': 'Department of Biostatistics, School of Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Nader Shakiba', 'Initials': 'NS', 'LastName': 'Maram', 'Affiliation': 'Ahvaz Jundishapur Nanotechnology Research Center, Ahvaz, Iran.'}, {'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Montazeri', 'Affiliation': 'Department of Midwifery, Reproductive Health Promotion Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",BioMedicine,['10.37796/2211-8039.1038'] 3870,33854925,Evaluation of sodium valproate low dose efficacy in radicular pain management and it's relation with pharmacokinetics parameters.,"Background Radiculopathy due to lumbar or cervical disc disease is the most common chronic neuropathic pain in adults. The aim of present study was evaluation of low dose of sodium valproate (VPA) on radicular pain and determining VPA pharmacokinetics. Materials and Methods In this double blind randomized placebo control clinical study, 80 patients with established lumbar or cervical radicular pain, have been randomly allocated into two study groups: 40 have received sodium valproate 200 mg/day and Celecoxib 100 mg/day and acetaminophen 500 mg PRN as rescue medication, and second group has received placebo, Celecoxib and acetaminophen. Quantitative assessment of pain was done by visual analogue scale (VAS) prior to perform the intervention and after ten days (treatment duration). Blood sample has been taken for determining mean through concentration after five half-lives. Evaluation of plasma concentration of VPA and that of efficacy on pain score relationship by comparing VAS before and after the therapy was done. Results Group A and B have demonstrated significant alleviation in mean VAS score; -21.97 ± 25.41, -14.39 ± 23.03 respectively (P < 0.001). The mean plasma concentration of VPA in group A was: 26.9 ± 13.5 mg/L. Moreover, no significant correlation was seen between pain score with age, gender, and weight (p > 0.05). Conclusion Low dose of sodium valproate especially together with NSAIDs demonstrated good efficacy in lumbar and cervical radicular pain management.",2020,"Group A and B have demonstrated significant alleviation in mean VAS score; -21.97 ± 25.41, -14.39 ± 23.03 respectively (P < 0.001).","['chronic neuropathic pain in adults', '80 patients with established lumbar or cervical radicular pain']","['sodium valproate (VPA', 'sodium valproate 200 mg/day and Celecoxib 100 mg/day and acetaminophen 500 mg PRN', 'sodium valproate', 'placebo, Celecoxib and acetaminophen', 'placebo']","['pain score', 'Quantitative assessment of pain', 'mean plasma concentration of VPA', 'pain score relationship', 'radicular pain and determining VPA pharmacokinetics']","[{'cui': 'C4544057', 'cui_str': 'Chronic neuropathic pain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C4552559', 'cui_str': 'Cervical radicular pain'}]","[{'cui': 'C0037567', 'cui_str': 'Valproate sodium'}, {'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0984629', 'cui_str': 'celecoxib 100 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0982958', 'cui_str': 'Acetaminophen 500 MG'}, {'cui': 'C0558288', 'cui_str': 'As required'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0278147', 'cui_str': 'Radicular pain'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",80.0,0.0457457,"Group A and B have demonstrated significant alleviation in mean VAS score; -21.97 ± 25.41, -14.39 ± 23.03 respectively (P < 0.001).","[{'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Ghasemian', 'Affiliation': 'Department of Clinical Pharmacy, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Mohammad Bagher', 'Initials': 'MB', 'LastName': 'Owlia', 'Affiliation': 'Department of Internal Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Mosaddegh', 'Affiliation': 'Department of Toxicology, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Masoud Nakhaie', 'Initials': 'MN', 'LastName': 'Nejad', 'Affiliation': 'Department of Pharmaceutical Sciences, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Seyed Mojtaba', 'Initials': 'SM', 'LastName': 'Sohrevardi', 'Affiliation': 'Department of Clinical Pharmacy, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}]",BioMedicine,['10.37796/2211-8039.1039'] 3871,33854910,"Effect of evening primrose oil on postoperative pain after appendectomy: A double-blind, randomized, clinical trial.","Background and objective Despite advances in surgical techniques and pharmacology, postoperative pain remains a common problem after appendectomy, and its management continues to be suboptimal. The aim of this study was to evaluate the effect of evening primrose oil on the reduction of postoperative pain after appendectomy. Materials and methods In a double-blind, randomized, clinical trial, a total of 80 adults patients with acute appendicitis who were undergoing appendectomy at the Shahid Beheshti Emdad Hospital in Sabzevar, were included. Patients were randomly allocated into two equally sized groups (n = 40). In postoperative period and after recovering from the anesthesia, each of the intervention and control groups received one evening primrose (1000 mg) or placebo capsules every 30 min for 3 times, respectively. All patients in both groups were asked to rate the intensity of their pain on a 0-10 point Visual Analogue Scale (VAS) and also McGill pain questionnaire, before and 1 h after the last administration of the drug, postoperatively. Results In patients who received evening primrose, both VAS and McGill pain intensity scores significantly decreased after intervention, when compared prior to initiation of the intervention (p < 0.0001). While in the control group, changes of pain intensity scores were not significantly different before and after the intervention (p > 0.05). Conclusion It seems that oral evening primrose can be used as a simple and safe potential adjunctive treatment for postoperative pain control after appendectomy.",2020,"In patients who received evening primrose, both VAS and McGill pain intensity scores significantly decreased after intervention, when compared prior to initiation of the intervention (p < 0.0001).","['80 adults patients with acute appendicitis who were undergoing appendectomy at the Shahid Beheshti Emdad Hospital in Sabzevar, were included', 'after appendectomy']","['evening primrose oil', 'evening primrose', 'placebo']","['changes of pain intensity scores', 'VAS and McGill pain intensity scores', 'postoperative pain', 'intensity of their pain on a 0-10 point Visual Analogue Scale (VAS) and also McGill pain questionnaire']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0700602', 'cui_str': 'Evening primrose oil'}, {'cui': 'C0874067', 'cui_str': 'Evening primrose extract'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}]",80.0,0.170356,"In patients who received evening primrose, both VAS and McGill pain intensity scores significantly decreased after intervention, when compared prior to initiation of the intervention (p < 0.0001).","[{'ForeName': 'Manijeh Yousefi', 'Initials': 'MY', 'LastName': 'Moghadam', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Nemat-Shahi', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Davood', 'Initials': 'D', 'LastName': 'Soroosh', 'Affiliation': 'Faculty of Medicine, Sabzevar University of Medical Sciences Sabzevar, Iran.'}, {'ForeName': 'Mahbobeh', 'Initials': 'M', 'LastName': 'Nemat-Shahi', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Sabzevar University of Medical Sciences Sabzevar, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Asadi', 'Affiliation': 'Deputy of Health, Sabzevar University of Medical Sciences Sabzevar, Iran.'}]",BioMedicine,['10.37796/2211-8039.1002'] 3872,33854907,Comparison between volunteer- and expert-led versions of a community-based weight-loss intervention.,"This study compared the effect of volunteer- and expert-led versions of a community-based weight-loss intervention in a non-randomized comparative trial conducted in Ibaraki, Japan from 2016 to 2017. Participants were 145 Japanese adults with overweightness or obesity, aged 20-69 years, with 77 in a volunteer-led group and 68 in an expert-led group. Both groups received the same program content and intervention period. Community volunteers were trained in four or five 3-hour training sessions while experts were highly trained and experienced professionals in the fields of exercise and nutrition prescription. Participants were also instructed to maintain a well-balanced, low-energy diet. The primary outcome measure was body weight change. In the volunteer- and expert-led groups, 58 of 77 (75%) and 61 of 68 (95%) participants completed the 12-week intervention, respectively. The mean (95% confidence interval, CI) weight loss of the volunteer-led group was 6.4 (95% CI: 5.6-7.2) kg, corresponding to 8.9% of initial body weight, while that of the expert-led group was 6.3 (95% CI: 5.5-7.1) kg, corresponding to 8.2% of the initial body weight. The proportion of participants who completed the course was significantly higher in the expert-led group ( P  < 0.05); however, the degree of the body weight change was similar for both groups. With improvement in the completion proportion of the volunteer-led weight-loss interventions, such programs could be an alternative strategy for the wide-scale dissemination of low-cost obesity management.",2021,"The proportion of participants who completed the course was significantly higher in the expert-led group ( P  < 0.05); however, the degree of the body weight change was similar for both groups.","['Community volunteers', 'Participants were 145 Japanese adults with overweightness or obesity, aged 20-69\xa0years, with 77 in a volunteer-led group and 68 in an expert-led group', 'Ibaraki, Japan from 2016 to 2017']","['volunteer- and expert-led versions of a community-based weight-loss intervention', 'training sessions while experts were highly trained and experienced professionals in the fields of exercise and nutrition prescription']","['body weight change', 'CI) weight loss']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0660279', 'cui_str': 'IS 145'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}]","[{'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",145.0,0.0184623,"The proportion of participants who completed the course was significantly higher in the expert-led group ( P  < 0.05); however, the degree of the body weight change was similar for both groups.","[{'ForeName': 'Ryoko', 'Initials': 'R', 'LastName': 'Mizushima', 'Affiliation': 'Graduate School of Comprehensive Human Sciences, University of Tsukuba, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Nakata', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Sasai', 'Affiliation': 'Research Team for Promoting Independence and Mental Health, Tokyo Metropolitan Institute of Gerontology, Japan.'}, {'ForeName': 'Xinyu', 'Initials': 'X', 'LastName': 'Zuo', 'Affiliation': 'Graduate School of Comprehensive Human Sciences, University of Tsukuba, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Maeda', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Japan.'}, {'ForeName': 'Kiyoji', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Japan.'}]",Preventive medicine reports,['10.1016/j.pmedr.2021.101370'] 3873,33854860,Comparing Minor Hand Procedures Performed with or without the Use of a Tourniquet: A Randomized Controlled Trial.,"Background Carpal tunnel syndrome and trigger finger are two of the most common conditions treated by the hand surgeon. During these procedures, a tourniquet is often used to minimize bleeding and improve visualization of the operative field. However, it may be associated with pain and discomfort. To date, there are few prospective studies investigating the safety and patient-centered outcomes of tourniquet-free minor hand procedures. Methods This is a randomized controlled trial comparing patients undergoing open carpal tunnel or trigger finger release with or without the use of a tourniquet. Perioperative subjective patient experience was investigated for both techniques. This was measured based on a numerical rating scale for pain, anxiety, and overall satisfaction. In addition, this was an equivalence trial in terms of operative time, bleeding scores, and perioperative complication rates. Results A total of 67 patients were recruited. Both groups were similar with respect to distribution of age, sex, handedness, anti-platelet use, and tobacco use. Median scores for operative time, anxiety, and overall satisfaction were comparable between the 2 groups. With regard to patient discomfort, median scores were significantly higher in the tourniquet group when compared with the no tourniquet group (3.58 versus 1.68, respectively, P = 0.02). Bleeding scores for the tourniquet group were significantly lower than for the no tourniquet group (1.14 versus 1.90, respectively, P = 0.001). Conclusions The application of wide awake local anesthesia no tourniquet (WALANT) in minor hand surgery procedures has been shown to decrease tourniquet-associated discomfort, improving perioperative patient experience. Additionally, it demonstrated the noninferiority of the tourniquet-free technique with respect to operative time and the rate of perioperative complications.",2021,"Bleeding scores for the tourniquet group were significantly lower than for the no tourniquet group (1.14 versus 1.90, respectively, P = 0.001). ","['A total of 67 patients were recruited', 'patients undergoing open carpal tunnel or trigger finger release with or without the use of a tourniquet']",['wide awake local anesthesia no tourniquet (WALANT'],"['Median scores for operative time, anxiety, and overall satisfaction', 'numerical rating scale for pain, anxiety, and overall satisfaction', 'pain and discomfort', 'patient discomfort, median scores', 'Bleeding scores', 'operative time, bleeding scores, and perioperative complication rates', 'operative time and the rate of perioperative complications']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0407128', 'cui_str': 'Release of trigger finger'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}]","[{'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}]",67.0,0.100529,"Bleeding scores for the tourniquet group were significantly lower than for the no tourniquet group (1.14 versus 1.90, respectively, P = 0.001). ","[{'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Saleh', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Université de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Saleh', 'Affiliation': 'Faculty of Medicine, Université de Sherbrooke, Sherbrooke, Québec, Canada.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Govshievich', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Université de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': 'Ferland-Caron', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Université de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Jenny C', 'Initials': 'JC', 'LastName': 'Lin', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Université de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Dominique M', 'Initials': 'DM', 'LastName': 'Tremblay', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Université de Montréal, Montréal, Québec, Canada.'}]",Plastic and reconstructive surgery. Global open,['10.1097/GOX.0000000000003513'] 3874,33854726,Effect of simultaneous application of arthrocentesis and occlusal splint versus splint in management of non-reducing TMJ disc displacement.,"Background/Purpose This study aimed to compare the effect of four approaches in the treatment of TMJ disc displacement without reduction (DDwoR). Materials and methods Thirty-two patients (40 joints) with mean age 28.025 ± 7.18 (23 female patients and nine male patients) were assigned randomly into four groups (10 joints in each group). Group I, patients were treated by centric splint. Group II, patients were treated by distraction splint. Group III, patients were treated by arthrocentesis and centric splint, while group IV patients were treated by arthrocentesis and distraction splint. The groups were compared in terms of joint function (mouth opening), joint pain through joint palpation, and use of visual analog scale (VAS). These records were taken preoperatively, two weeks, one month, three, and six months postoperatively. Also, the presence of disc recapture was evaluated in all patients on MRI at the end of the treatment period. Results Significant improvements in all parameters were recorded in all groups. At two weeks postoperatively, there was a significant improvement in all parameters in group III and group IV than group I and group II, while there was no statistical difference between group III and group IV. Regarding mouth opening and joint palpation, there was a significant improvement in group III than group I and group II. Also, there was a significant improvement in group IV than group II at the subsequent follow-up periods. Regarding VAS, at one and three months postoperatively, there was a significant improvement in group III than other groups. Conclusion However, both types of splints provide better results without a statistical difference; the simultaneous application of arthrocentesis and occlusal splint decreases pain and improving the function effectively and more rapidly.",2021,"The groups were compared in terms of joint function (mouth opening), joint pain through joint palpation, and use of visual analog scale (VAS).",['Materials and methods\n\n\nThirty-two patients (40 joints) with mean age 28.025\u202f±\u202f7.18 (23 female patients and nine male patients'],"['TMJ disc displacement without reduction (DDwoR', 'arthrocentesis and occlusal splint versus splint', 'distraction splint', 'centric splint', 'arthrocentesis and centric splint', 'arthrocentesis and distraction splint']","['joint function (mouth opening), joint pain through joint palpation, and use of visual analog scale (VAS', 'presence of disc recapture']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0039493', 'cui_str': 'Temporomandibular joint structure'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0204854', 'cui_str': 'Arthrocentesis'}, {'cui': 'C0162528', 'cui_str': 'Occlusal appliance'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}]","[{'cui': 'C0542330', 'cui_str': 'Joint mobilization'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",,0.00482593,"The groups were compared in terms of joint function (mouth opening), joint pain through joint palpation, and use of visual analog scale (VAS).","[{'ForeName': 'Alaa Abdelqader', 'Initials': 'AA', 'LastName': 'Altaweel', 'Affiliation': 'Oral and Maxillofacial Surgery Department, Faculty of Dental Medicine for Boys, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Hussein Abdelfattah', 'Initials': 'HA', 'LastName': 'Ismail', 'Affiliation': 'Removable Prosthodontic Department, Faculty of Oral and Dental Surgery & Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Mostafa I', 'Initials': 'MI', 'LastName': 'Fayad', 'Affiliation': 'Substitutive Dental Science Department, College of Dentistry, Taibah University, Saudi Arabia.'}]",Journal of dental sciences,['10.1016/j.jds.2020.08.008'] 3875,33854725,Efficacy of different calcium silicate materials as pulp-capping agents: Randomized clinical trial.,"Background/purpose Calcium hydroxide-based materials were the gold standard in vital pulp therapies for decades' despite of several shortcomings. However, calcium silicates have been discussed as an alternative to overcome these drawbacks. It was aimed to investigate the in-vivo effectiveness of different calcium silicates based materials in pulp capping in this study. Materials and methods A parallel-design, randomized controlled trial with 213 patients who has deep dentin caries, vital pulps and without spontaneous pain or history of swelling was designed. 525 M teeth were randomized, blinded and allocated to one of the five groups for pulp capping treatment (n = 105). All teeth were followed up clinically and radiographically (after 1st, 6th, 12th and 36th months) by blinded investigators. The clinical and radiographic success, and the effect of the pulp exposure to the success rate analyzed with Wald chi-square and Z tests. Results Clinical and radiographic success of MTA+ (86.3%, 85.4%) and Biodentine (79.4%, 80.1%) were found the highest. Although results of Theracal LC group (72.1%, 73.6%) were better than Dycal group (69.4%, 70.2%), the difference was nonsignificant (p > 0.05). Only in light-cured groups, (TheraCal LC & LC Calcihyd) pulpal exposure size effected the success of the materials (p < 0.05). MTA+ and Biodentine resulted better scores, when compared with TheraCal LC in large pulpal exposures (p < 0.05). Conclusion After 36-month follow-up, both MTA+ and Biodentine were found to be the appropriate material for direct pulp capping in permanent teeth. The filler ingredient of the Theracal-LC eases the usage of calcium silicates but decreases the success rate.",2021,"MTA+ and Biodentine resulted better scores, when compared with TheraCal LC in large pulpal exposures (p < 0.05). ","['213 patients who has deep dentin caries, vital pulps and without spontaneous pain or history of swelling was designed', '525\u202fM teeth']","['calcium silicate materials as pulp-capping agents', 'pulp capping treatment', 'TheraCal LC', 'MTA+ and Biodentine', 'Calcium hydroxide-based materials']","['Biodentine', 'radiographic success of MTA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0266846', 'cui_str': 'Dental caries extending into dentin'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C1997216', 'cui_str': 'Spontaneous pain'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0054483', 'cui_str': 'calcium silicate'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C2936256', 'cui_str': 'Pulp Capping Agents'}, {'cui': 'C0011402', 'cui_str': 'Capping, Dental Pulp'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4547168', 'cui_str': 'TheraCal'}, {'cui': 'C3502756', 'cui_str': 'biodentine'}, {'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C3502756', 'cui_str': 'biodentine'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}]",213.0,0.13836,"MTA+ and Biodentine resulted better scores, when compared with TheraCal LC in large pulpal exposures (p < 0.05). ","[{'ForeName': 'Cem', 'Initials': 'C', 'LastName': 'Peskersoy', 'Affiliation': 'Department of Restorative Dentistry, Ege University Faculty of Dentistry, Izmir, Turkey.'}, {'ForeName': 'Jusuf', 'Initials': 'J', 'LastName': 'Lukarcanin', 'Affiliation': 'Department of Restorative Dentistry, Ege University Faculty of Dentistry, Izmir, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Turkun', 'Affiliation': 'Department of Restorative Dentistry, Ege University Faculty of Dentistry, Izmir, Turkey.'}]",Journal of dental sciences,['10.1016/j.jds.2020.08.016'] 3876,33854720,Evaluation of the efficacy of lycopene gel compared with minocycline hydrochloride microspheres as an adjunct to nonsurgical periodontal treatment: A randomised clinical trial.,"Background/purpose The prescription of antibiotics as an adjunct to mechanical periodontal therapy in patients with severe periodontitis is recommended; however, the side effects of antibiotics are a major concern. The aim of this study was to evaluate the efficacy of lycopene (Lyc) antioxidant gel versus minocycline hydrochloride microspheres (ARISTIN) as an adjunct to the nonsurgical treatment of periodontitis. Materials and methods Three identical periodontal pockets/patient received root surface debridement followed by the random application of either ARISTIN, Lyc, or placebo gel (control, Ctrl). Clinical parameters, plaque index, bleeding on probing, probing pocket depth, and clinical attachment loss, were recorded at the baseline and after 30 days. Additionally, the levels of interleukin-8 (IL-8), matrix metallopeptidase 9, and tissue inhibitor of metalloproteinases 1 (TIMP1) in gingival crevicular fluid samples were assessed at the same time points. Results Twenty-three patients with periodontitis completed the study. Both ARISTIN and Lyc treatments showed significantly greater gains in attachment (1.94 ± 1.33 and 1.72 ± 0.88, respectively) than the Ctrl treatment (1.04 ± 0.96). Compared with those in the Ctrl, only ARISTIN showed a significant reduction in IL-8 level, whereas TIMP1 levels were significantly upregulated in the Lyc gel and ARISTIN sites. The effect size estimation indicated that Lyc gel exhibited considerably greater efficacy than the Ctrl gel. Conclusion Lyc gel and ARISTIN offer almost equal improvement in both clinical and biochemical parameters of periodontitis.",2021,"Additionally, the levels of interleukin-8 (IL-8), matrix metallopeptidase 9, and tissue inhibitor of metalloproteinases 1 (TIMP1) in gingival crevicular fluid samples were assessed at the same time points. ","['patients with severe periodontitis', 'Results\n\n\nTwenty-three patients with periodontitis completed the study']","['lycopene (Lyc) antioxidant gel versus minocycline hydrochloride microspheres', 'minocycline hydrochloride microspheres', 'lycopene gel', 'placebo gel (control, Ctrl']","['IL-8 level', 'Clinical parameters, plaque index, bleeding on probing, probing pocket depth, and clinical attachment loss', 'levels of interleukin-8 (IL-8), matrix metallopeptidase 9, and tissue inhibitor of metalloproteinases 1 (TIMP1) in gingival crevicular fluid samples', 'TIMP1 levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0065331', 'cui_str': 'lycopene'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0026186', 'cui_str': 'Minocycline hydrochloride'}, {'cui': 'C0026032', 'cui_str': 'Microbeads'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C2736430', 'cui_str': 'Matrix metallopeptidase 9'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",23.0,0.0565539,"Additionally, the levels of interleukin-8 (IL-8), matrix metallopeptidase 9, and tissue inhibitor of metalloproteinases 1 (TIMP1) in gingival crevicular fluid samples were assessed at the same time points. ","[{'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': 'College of Dentistry, Mustansiriya University, Baghdad, Iraq.'}, {'ForeName': 'Saif', 'Initials': 'S', 'LastName': 'Saliem', 'Affiliation': 'College of Dentistry, University of Baghdad, Baghdad, Iraq.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Abdulkareem', 'Affiliation': 'College of Dentistry, University of Baghdad, Baghdad, Iraq.'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Radhi', 'Affiliation': 'College of Dentistry, Mustansiriya University, Baghdad, Iraq.'}, {'ForeName': 'Sarhang', 'Initials': 'S', 'LastName': 'Gul', 'Affiliation': 'College of Dentistry, University of Sulaimani, Sulaymaniyah, Iraq.'}]",Journal of dental sciences,['10.1016/j.jds.2020.09.009'] 3877,33854714,Acemannan-induced tooth socket healing: A 12-month randomized controlled trial.,"Background/purpose Natural compounds have become alternatives for bone regeneration. Acemannan, the main polysaccharide extracted from Aloe vera, has been demonstrated as a promising osteoinductive material in vitro and in vivo . This clinical study investigated the effect of acemannan on tooth socket healing. Materials and methods Thirty-five otherwise healthy patients, 18-25 years old and diagnosed with horizontal or vertical partial impaction of the lower third molars, were enrolled in this randomized controlled trial. After removing the teeth, the sockets randomly received one of the following treatments: spontaneous blood-clotting (control), 20 mg acemannan sponge, or 50 mg acemannan sponge. Cone-beam computed tomography of the mandible was performed immediately (baseline), and at 3-, 6-, and 12-months postoperatively; the data were analyzed using the OsiriX MD program. Bone healing in the socket was determined measuring the socket volume. One-way ANOVA was used to analyze the differences within each group and between groups. Results Thirty-five patients with 43 partially impacted lower third molars participated in this study. No patients exhibited alveolar osteitis or secondary infection. Compared with baseline, all groups showed significant reduction in socket volume at all observation time-points ( p  < 0.05). The 50 mg acemannan group had a significantly greater reduction in socket volume compared with the control at all postoperative time-points ( p  < 0.05). The 20 mg group had a significantly greater reduction in socket volume compared with the control at 3-months postoperatively ( p  < 0.05). Conclusion We conclude that acemannan increases bone healing at 3-, 6-, and 12-months after removal of partially impacted mandibular third molars.",2021,The 50 mg acemannan group had a significantly greater reduction in socket volume compared with the control at all postoperative time-points ( p  < 0.05).,"['Materials and methods\n\n\nThirty-five otherwise healthy patients, 18-25 years old and diagnosed with horizontal or vertical partial impaction of the lower third molars', 'Thirty-five patients with 43 partially impacted lower third molars participated in this study']","['acemannan', 'spontaneous blood-clotting (control), 20\u202fmg acemannan sponge, or 50\u202fmg acemannan sponge', 'Acemannan', 'Acemannan-induced tooth socket healing']","['bone healing', 'socket volume', 'Bone healing', 'alveolar osteitis or secondary infection']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0227191', 'cui_str': 'Structure of lower third of esophagus'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0050408', 'cui_str': 'acemannan'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0032699', 'cui_str': 'Phylum Porifera'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0227130', 'cui_str': 'Structure of alveolus dentalis'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C1321023', 'cui_str': 'Bone healing status'}, {'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0013240', 'cui_str': 'Alveolar periostitis'}, {'cui': 'C0442886', 'cui_str': 'Secondary infection'}]",35.0,0.0262349,The 50 mg acemannan group had a significantly greater reduction in socket volume compared with the control at all postoperative time-points ( p  < 0.05).,"[{'ForeName': 'Ngoc Bao', 'Initials': 'NB', 'LastName': 'Vu', 'Affiliation': 'Dental Biomaterials Science Program, Graduate School, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Vannaporn', 'Initials': 'V', 'LastName': 'Chuenchompoonut', 'Affiliation': 'Department of Oral Radiology, Faculty of Dentistry, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Pornchai', 'Initials': 'P', 'LastName': 'Jansisyanont', 'Affiliation': 'Department of Oral Surgery, Faculty of Dentistry, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Polkit', 'Initials': 'P', 'LastName': 'Sangvanich', 'Affiliation': 'Department of Chemistry, Faculty of Sciences, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Thanh Ha', 'Initials': 'TH', 'LastName': 'Pham', 'Affiliation': 'Department of Implantology, Hanoi National Hospital of Odonto-Stomatology, Hanoi, Viet Nam.'}, {'ForeName': 'Pasutha', 'Initials': 'P', 'LastName': 'Thunyakitpisal', 'Affiliation': 'Research Unit of Herbal Medicine, Biomaterial, and Material for Dental Treatment, Department of Anatomy, Faculty of Dentistry, Chulalongkorn University, Bangkok, Thailand.'}]",Journal of dental sciences,['10.1016/j.jds.2020.10.003'] 3878,33854711,"Efficacy of antioxidant mouthwash in the reduction of halitosis: A randomized, double blind, controlled crossover clinical trial.","Background/purpose Halitosis is the unpleasant and offensive odour in exhaled air, which is linked to the presence of volatile sulphur compounds (VSC). Different mouthwashes have been used to treat halitosis. The objective of this study was to test the effect of an antioxidant (AO) mouthwash, and mouthwash containing [0.05% chlorhexidine, 0.05% cetylpyridinium chloride, and 0.14% zinc lactate (CHX-CPC-Zn)] on VSC. Material and methods Thirty-five subjects with halitosis participated in this clinical trial. At the baseline visit, a breath sample was taken and analyzed for the level of hydrogen sulphide (H 2 S), methyl mercaptan (CH 3 SH), and dimethyl sulphide (CH 3 SCH 3 ) using portable gas chromatography (OralChroma™). Two mouthwashes were randomly provided to each subject in addition to saline solution (NaCl 0.9%) as control. Subjects were instructed to rinse with 20 ml of the mouthwash for 1 min twice daily for 2 weeks. At second visit, post-treatment breath sample was taken. Afterward, the patient was asked to refrain from using mouthwash for a washout period of 1 week. A similar procedure was repeated for each mouthwash interval. Results No significant differences in VSC level between all three groups were detected at baseline. A significant reduction in VSC level was obtained after using CHX-CPC-Zn mouthwash. On other hand, both AO mouthwash and saline had no significant impact on the level of VSC. Conclusion CHX-CPC-Zn mouthwash has a significant effect on VSC level reduction in subjects with confirmed halitosis. Besides, using AO mouthwash regularly for 2 weeks did not have any impact on improving the level of halitosis.",2021,"Besides, using AO mouthwash regularly for 2 weeks did not have any impact on improving the level of halitosis.","['subjects with confirmed halitosis', 'Material and methods\n\n\nThirty-five subjects with halitosis participated in this clinical trial']","['AO mouthwash and saline', 'antioxidant (AO) mouthwash, and mouthwash containing [0.05% chlorhexidine, 0.05% cetylpyridinium chloride, and 0.14% zinc lactate (CHX-CPC-Zn', 'antioxidant mouthwash', 'saline solution (NaCl 0.9%) as control']","['reduction of halitosis', 'VSC level', 'level of halitosis', 'level of VSC', 'VSC level reduction']","[{'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0018520', 'cui_str': 'Breath smells unpleasant'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0007907', 'cui_str': 'Cetylpyridinium chloride'}, {'cui': 'C4517430', 'cui_str': '0.14'}, {'cui': 'C2240534', 'cui_str': 'ZINC LACTATE'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018520', 'cui_str': 'Breath smells unpleasant'}, {'cui': 'C0443769', 'cui_str': 'Volatile agent'}, {'cui': 'C0038776', 'cui_str': 'Sulfur compound'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",35.0,0.319661,"Besides, using AO mouthwash regularly for 2 weeks did not have any impact on improving the level of halitosis.","[{'ForeName': 'Duaa', 'Initials': 'D', 'LastName': 'Alsaffar', 'Affiliation': 'Graduate Program in Periodontics, Department of Periodontics and Community Dentistry, College of Dentistry, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Hamad', 'Initials': 'H', 'LastName': 'Alzoman', 'Affiliation': 'Department of Periodontics and Community Dentistry, College of Dentistry, King Saud University, Riyadh, Saudi Arabia.'}]",Journal of dental sciences,['10.1016/j.jds.2020.10.005'] 3879,33854657,Perioperative Antibiotic Prophylaxis: An Educative Intervention Significantly Increases Compliance.,"Background Implementation of guidelines in daily clinical practice is often suboptimal, mainly due to doctors' poor compliance with them. Perioperative antibiotic prophylaxis (PAP) is many times administered in patients undergoing elective surgery without proper indication or for longer time than needed. Aim of this study is to investigate the effect of a simple intervention on the compliance of the medical staff with the American Society of Health-System Pharmacists (ASHP) guidelines concerning PAP administration. Methods A prospective 3-month audit took place including routine surgical procedures (laparoscopic cholecystectomy, inguinal hernia repair and thyroidectomy). An intervention aiming to educate the medical staff was implemented. The intervention included the demonstration of a poster and the training of the medical staff over the guidelines. A re-audit recorded the changes in daily clinical practice. Results The compliance rate regarding the number of PAP doses significantly increased from 0% before the intervention to 68.8% after the intervention for hernia repair and to 53.1% for laparoscopic cholecystectomy. The adherence rate in thyroidectomies increased from 25% to 50%, but without statistical significance. No significant difference was found for other parameters of PAP administration, namely the type of antibiotic used and the timing of the dose administration. Regarding secondary outcomes, hospitalization days were reduced, and cost of antibiotics was significantly decreased (P < 0.05). Conclusions A simple intervention intending to educate the medical staff was successful in achieving significant improvement on the compliance rate with the PAP guidelines, highlighting the importance of promoting adherence to the already existing, well-established guidelines.",2021,"Regarding secondary outcomes, hospitalization days were reduced, and cost of antibiotics was significantly decreased (P < 0.05). ","['patients undergoing elective surgery without proper indication or for longer time than needed', 'medical staff with the American Society of Health-System Pharmacists (ASHP) guidelines concerning PAP administration']","['simple intervention', 'laparoscopic cholecystectomy', 'Educative Intervention', 'Perioperative Antibiotic Prophylaxis', 'routine surgical procedures (laparoscopic cholecystectomy, inguinal hernia repair and thyroidectomy', 'Perioperative antibiotic prophylaxis (PAP']","['adherence rate in thyroidectomies', 'compliance rate regarding the number of PAP doses', 'cost of antibiotics', 'hospitalization days']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0025106', 'cui_str': 'Medical Staffs'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.0105333,"Regarding secondary outcomes, hospitalization days were reduced, and cost of antibiotics was significantly decreased (P < 0.05). ","[{'ForeName': 'Eirini Chrysovalantou', 'Initials': 'EC', 'LastName': 'Martzivanou', 'Affiliation': 'Second Surgical Propedeutic Department, Hippocration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Kyriakos', 'Initials': 'K', 'LastName': 'Psarras', 'Affiliation': 'Second Surgical Propedeutic Department, Hippocration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Monioudis', 'Affiliation': 'Second Surgical Propedeutic Department, Hippocration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Kyriakos', 'Initials': 'K', 'LastName': 'Vamvakis', 'Affiliation': 'Directorate of Public Health, Prefecture of Kavala, Kavala, Greece.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Nikolaidou', 'Affiliation': 'Second Surgical Propedeutic Department, Hippocration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Geropoulos', 'Affiliation': 'Thoracic Surgery Department, University College London Hospitals, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Efstathios T', 'Initials': 'ET', 'LastName': 'Pavlidis', 'Affiliation': 'Second Surgical Propedeutic Department, Hippocration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Symeonidis', 'Affiliation': 'Second Surgical Propedeutic Department, Hippocration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Theodoros E', 'Initials': 'TE', 'LastName': 'Pavlidis', 'Affiliation': 'Second Surgical Propedeutic Department, Hippocration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}]",Journal of clinical medicine research,['10.14740/jocmr4447'] 3880,33854598,"Lower-dose decitabine improves clinical response compared with best supportive care in lower-risk MDS patients: a prospective, multicenter phase 2 study.","Purpose: To explore the efficacy and safety of lower-dose decitabine in patients with lower-risk MDS, a prospective multicenter phase II study was conducted to compare decitabine with the best supportive care (BSC). Methods: Patients diagnosed with lower-risk MDS from September 2013 to August 2018 were assigned to the decitabine group or the BSC group. Decitabine (12 mg/m 2 /day) was administered over 1 hour/day for 5 consecutive days in a 4-week cycle. BSC, including growth factors, transfusion, thalidomide, lenalidomide, and immunosuppressive agents were given consecutively. The endpoints included the proportion of patients who achieved overall response (OR) in the first 2 or 3 courses, event-free survival (EFS), and overall survival (OS). Results: A total of recruited 82 patients were analyzed. In the decitabine group, 65.9% (27/41) achieved OR after 2 or 3 cycles of treatment, compared with 22.0% (9/41) in the BSC group (p <0.01). Besides, 44.0% (11/25) in the decitabine group became independent of RBC/Platelets transfusion, compared with 27.8% (5/18) in the BSC group. Patients with gene mutation and treated with decitabine achieved a higher OR rate, compared with those without gene mutation [72.0% (18/25) vs 11.5% (3/26), p <0.01]. There was no significant difference in the median EFS between the decitabine and BSC groups (20.6 vs 14.3 months respectively, p = 0.665). In the decitabine group, the most significant adverse events were infections of any grades or neutropenic fever (46.3%, 19/41) and one patient (4.2%) died of acute cerebral infarction within 6 weeks of treatment. Conclusion: Lower-dose decitabine demonstrated promising clinical response with acceptable toxicity profiles in patients with low- and intermediate 1-risk MDS. A higher response rate to decitabine was observed in patients with mutated genes. Therefore, lower-dose decitabine can be advocated for patients with low-risk MDS and mutated genes.",2021,"Patients with gene mutation and treated with decitabine achieved a higher OR rate, compared with those without gene mutation [72.0% (18/25) vs 11.5% (3/26), p <0.01].","['patients with low- and intermediate 1-risk MDS', 'A total of recruited 82 patients were analyzed', 'Patients diagnosed with lower-risk MDS from September 2013 to August 2018', 'patients with low-risk MDS and mutated genes', 'patients with lower-risk MDS', 'lower-risk MDS patients', 'patients with mutated genes']","['BSC', 'decitabine', 'Decitabine']","['RBC/Platelets transfusion', 'clinical response', 'BSC, including growth factors, transfusion, thalidomide, lenalidomide, and immunosuppressive agents', 'higher OR rate', 'response rate to decitabine', 'proportion of patients who achieved overall response (OR) in the first 2 or 3 courses, event-free survival (EFS), and overall survival (OS', 'efficacy and safety', 'died of acute cerebral infarction', 'neutropenic fever', 'median EFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0017337', 'cui_str': 'Gene'}]","[{'cui': 'C0049065', 'cui_str': 'decitabine'}]","[{'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0086818', 'cui_str': 'Platelet transfusion'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0049065', 'cui_str': 'decitabine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",82.0,0.0417812,"Patients with gene mutation and treated with decitabine achieved a higher OR rate, compared with those without gene mutation [72.0% (18/25) vs 11.5% (3/26), p <0.01].","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ye', 'Affiliation': 'MDS Center, Department of Hematology, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, Zhejiang Province, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Mei', 'Affiliation': 'MDS Center, Department of Hematology, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, Zhejiang Province, China.'}, {'ForeName': 'Yanling', 'Initials': 'Y', 'LastName': 'Ren', 'Affiliation': 'MDS Center, Department of Hematology, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, Zhejiang Province, China.'}, {'ForeName': 'Xinping', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'MDS Center, Department of Hematology, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, Zhejiang Province, China.'}, {'ForeName': 'Liya', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'MDS Center, Department of Hematology, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, Zhejiang Province, China.'}, {'ForeName': 'Weilai', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'MDS Center, Department of Hematology, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, Zhejiang Province, China.'}, {'ForeName': 'Juying', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'MDS Center, Department of Hematology, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, Zhejiang Province, China.'}, {'ForeName': 'Huifang', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Hematology, Tongde Hospital of Zhejiang Province, Hangzhou 310012, Zhejiang Province, China.'}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Hematology, Zhuji People's Hospital of Zhejiang Province, Zhuji 311800, Zhejiang Province, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zeng', 'Affiliation': 'Institute of Hematology, the First Hospital of Jiaxing City in Zhejiang Province, Jiaxing 314001, Zhejiang Province, China.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Tong', 'Affiliation': 'MDS Center, Department of Hematology, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, Zhejiang Province, China.'}]",Journal of Cancer,['10.7150/jca.56207'] 3881,32673785,Rectal and Urethro-Vesical Subregions for Toxicity Prediction After Prostate Cancer Radiation Therapy: Validation of Voxel-Based Models in an Independent Population.,"PURPOSE Recent voxel-based studies have shown that the dose to specific rectal and urethro-vesical subregions is predictive of toxicities after prostate cancer intensity modulated radiation therapy. The objective of this study was to validate the discriminatory power of these subregions with respect to the whole organs in a large independent population. METHODS AND MATERIALS The validation cohort consisted of 450 patients from the TROG03.04-RADAR trial treated with 3-dimensional conformal radiation therapy at 66 to 74 Gy. Previous voxel-based analyses identified an inferoanterior rectal subregion as predictive of rectal bleeding and 5 subregions in the urethra and the posterior and superior part of the bladder as predictive of urinary incontinence, dysuria, retention, and hematuria. In the validation cohort, these subregions were segmented in each patient's anatomy. Dose-volume histograms (DVHs) of the whole organs and the 6 subregions were compared bin-wise between patients with and without toxicities. The discriminatory power of DVHs for grade ≥2 toxicity endpoints was assessed using the area under the receiver operating characteristic curve (AUC). RESULTS Subregion DVHs were significantly different between patients with and without toxicities for late rectal bleeding (V44-V74), acute urinary incontinence (V68-V72), late dysuria (V56-V68), and late retention (V14-V64). The dose to the rectal subregion and the whole rectum were equally predictive of rectal bleeding (V68; AUC = 0.61). The doses to 3 out of the 5 urethro-vesical subregions were found to be more predictive than the dose to the whole bladder: in the urethra for acute incontinence (V71 AUC = 0.69 vs V71 AUC = 0.66), in the posterior part of the bladder for late dysuria (V65 AUC = 0.66 vs V68 AUC = 0.59), and late retention (V39 AUC = 0.74 vs no significant AUC). CONCLUSIONS Three subregions located in the urethra and the bladder were successfully validated as more predictive of urinary toxicity than the whole bladder for urinary incontinence, retention, and dysuria. Sparing the posterior part of the bladder in particular in treatment planning may reduce the risk of late urinary retention.",2020,The dose to the rectal subregion and the whole rectum were equally predictive of rectal bleeding (V68; AUC = 0.61).,['450 patients from the TROG03.04-RADAR trial treated with'],['3-dimensional conformal radiation therapy'],"['late retention (V39 AUC', 'late rectal bleeding (V44-V74), acute urinary incontinence (V68-V72), late dysuria (V56-V68), and late retention (V14-V64', 'rectal bleeding', 'urinary toxicity']","[{'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034513', 'cui_str': 'Radar'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0600521', 'cui_str': 'Conformal radiotherapy'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0018932', 'cui_str': 'Hematochezia'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0013428', 'cui_str': 'Dysuria'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",450.0,0.0823275,The dose to the rectal subregion and the whole rectum were equally predictive of rectal bleeding (V68; AUC = 0.61).,"[{'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Mylona', 'Affiliation': 'Univ Rennes, CLCC Eugène Marquis, INSERM, LTSI-UMR 1099, Rennes, France. Electronic address: eugenia.mylona@inserm.fr.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Ebert', 'Affiliation': 'Department of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, Australia; School of Physics, Mathematics and Computing, University of Western Australia, Perth, Australia; 5D Clinics, Perth, Australia.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Kennedy', 'Affiliation': 'Department of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Joseph', 'Affiliation': '5D Clinics, Perth, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Denham', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Australia.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Steigler', 'Affiliation': 'Prostate Cancer Trials Group, Faculty of Health, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Supiot', 'Affiliation': ""Department of Radiation Oncology, Institut de Cancérologie de l'Ouest, St-Herblain, France.""}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Acosta', 'Affiliation': 'Univ Rennes, CLCC Eugène Marquis, INSERM, LTSI-UMR 1099, Rennes, France.'}, {'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'de Crevoisier', 'Affiliation': 'Univ Rennes, CLCC Eugène Marquis, INSERM, LTSI-UMR 1099, Rennes, France.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.07.019'] 3882,32595022,Diagnostic value of frozen section examination of sentinel lymph nodes in early-stage cervical cancer at the time of ultrastaging.,"OBJECTIVES We aimed to assess the diagnostic value of frozen-section pathologic examination (FSE) of sentinel lymph nodes (SLN) in patients with early-stage cervical cancer. METHODS Two French prospective multicentric database on SLN biopsy for cervical cancer (SENTICOL I and II) were analysed. Patients with IA to IIA1 2018 FIGO stage, who underwent SLN biopsy with both FSE and ultrastaging examination were included. RESULTS AND DISCUSSION Between 2005 and 2012, 313 patients from 25 centers fulfilled the inclusion criteria. Metastatic involvement of SLN was diagnosed in 52 patients (16.6%). Macrometastases, micrometastases and isolated tumor cells (ITCs) were found in 27, 12 and 13 patients respectively. Among the 928 SLNs analysed, FSE identified 23 SLNs with macrometastases in 20 patients and 5 SLNs with micrometastases in 2 patients whereas no ITCs were identified. Ultrastaging of negative SLNs by FSE found macrometastases, micrometastases and ITCs in additional 7, 11 and 17 SLNs. Ultrastaging increased significantly the rate of patients with positive SLN from 7% to 16.6% (p < 0.0001). The sensitivity and the negative predictive value of FSE were 42.3% and 89.7% respectively or 56.4% and 94.1% if ITCs were excluded. False-negative cases were more frequent with tumor size ≥ 20 mm (OR = 4.46, 95%IC = [1.45-13.66], p = 0.01) and preoperative brachytherapy (OR = 4.47, 95%IC = [1.37-14.63], p = 0.01) and less frequent with patients included in higher volume center (>5 patients/year) (OR = 0.09, 95%IC = [0.02-0.51], p = 0.01). CONCLUSIONS FSE of SLN had a low sensitivity for detecting micrometastases and ITCs and a high negative predictive value for SLN status. Clinical impact of false-negative cases has to be assessed by further studies.",2020,"False-negative cases were more frequent with tumor size ≥ 20 mm (OR = 4.46, 95%IC = [1.45-13.66], p = 0.01) and preoperative brachytherapy (OR = 4.47, 95%IC = [1.37-14.63], p = 0.01) and less frequent with patients included in higher volume center (>5 patients/year)","['patients with early-stage cervical cancer', 'Between 2005 and 2012, 313 patients from 25 centers fulfilled the inclusion criteria', 'Patients with IA to IIA1 2018 FIGO stage, who underwent SLN biopsy with both FSE and ultrastaging examination were included']",['frozen-section pathologic examination (FSE) of sentinel lymph nodes (SLN'],"['sensitivity and the negative predictive value of FSE', 'Macrometastases, micrometastases and isolated tumor cells (ITCs', 'rate of patients with positive SLN', 'Metastatic involvement of SLN']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0450454', 'cui_str': 'FIGO Stage'}, {'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}, {'cui': 'C0016741', 'cui_str': 'Frozen Sections'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0016741', 'cui_str': 'Frozen Sections'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0677944', 'cui_str': 'Sentinel node'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0016741', 'cui_str': 'Frozen Sections'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0677944', 'cui_str': 'Sentinel node'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]",,0.072475,"False-negative cases were more frequent with tumor size ≥ 20 mm (OR = 4.46, 95%IC = [1.45-13.66], p = 0.01) and preoperative brachytherapy (OR = 4.47, 95%IC = [1.37-14.63], p = 0.01) and less frequent with patients included in higher volume center (>5 patients/year)","[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Balaya', 'Affiliation': 'Gynecology Department, University Hospital, University of Lausanne, Lausanne, Switzerland. Electronic address: vbalaya@hotmail.com.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Guani', 'Affiliation': 'Gynecology Department, University Hospital, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Benoit', 'Affiliation': 'Paris University, Faculty of Medicine, Paris, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Magaud', 'Affiliation': 'Public Health Department, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Bonsang-Kitzis', 'Affiliation': 'Gynecological and Breast Surgery and Cancerology Center, RAMSAY-Générale de Santé, Hôpital Privé des Peupliers, Paris, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ngô', 'Affiliation': 'Gynecological and Breast Surgery and Cancerology Center, RAMSAY-Générale de Santé, Hôpital Privé des Peupliers, Paris, France.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Le Frère-Belda', 'Affiliation': 'Paris University, Faculty of Medicine, Paris, France; Pathology Department, Georges Pompidou European Hospital, Paris, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Mathevet', 'Affiliation': 'Gynecology Department, University Hospital, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Lécuru', 'Affiliation': 'Paris University, Faculty of Medicine, Paris, France; Breast, Gynecology and Reconstructive Surgery Unit, Curie Institute, Paris, France.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.05.043'] 3883,31444046,Effect of Resistance Exercise on Depression in Mild Alzheimer Disease Patients With Sarcopenia.,,2020,,['Mild Alzheimer Disease Patients With Sarcopenia'],['Resistance Exercise'],[],"[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",[],,0.18864,,"[{'ForeName': 'Min Cheol', 'Initials': 'MC', 'LastName': 'Chang', 'Affiliation': 'Department of Physical Medicine and Rehabilitation (MCC, SK), College of Medicine, Yeungnam University, Republic of Korea. Electronic address: wheel633@ynu.ac.kr.'}, {'ForeName': 'Ah Young', 'Initials': 'AY', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy (AYL), College of Rehabilitation Sciences, Daegu University, Daegu, Republic of Korea.'}, {'ForeName': 'Soyoung', 'Initials': 'S', 'LastName': 'Kwak', 'Affiliation': 'Department of Physical Medicine and Rehabilitation (MCC, SK), College of Medicine, Yeungnam University, Republic of Korea.'}, {'ForeName': 'Sang Gyu', 'Initials': 'SG', 'LastName': 'Kwak', 'Affiliation': 'Department of Medical Statistics (SGK), College of Medicine, Catholic University of Daegu, Daegu, Republic of Korea.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2019.07.013'] 3884,33668679,Strong Dependence between Tryptophan-Related Fluorescence of Urine and Malignant Melanoma.,"Urine autofluorescence at 295 nm is significantly higher in patients with malignant melanoma at each clinical stage compared to the healthy group. The largest difference is in the early-stages and without metastases. With increasing stage, the autofluorescence at 295 nm decreases. There is also a significant negative correlation between autofluorescence and Clark classification. Based on our results, it is assumed that the way malignant melanoma grows also affects urinary autofluorescence.",2021,Urine autofluorescence at 295 nm is significantly higher in patients with malignant melanoma at each clinical stage compared to the healthy group.,[],[],['Urine autofluorescence'],[],[],"[{'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0544711', 'cui_str': 'Autofluorescence'}]",,0.100798,Urine autofluorescence at 295 nm is significantly higher in patients with malignant melanoma at each clinical stage compared to the healthy group.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Birková', 'Affiliation': 'Department of Medical and Clinical Biochemistry, Faculty of Medicine, Pavol Jozef Šafárik University in Košice, Tr. SNP 1, 040 11 Košice, Slovakia.'}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Valko-Rokytovská', 'Affiliation': 'Department of Chemistry, Biochemistry and Biophysics, University of Veterinary Medicine and Pharmacy in Košice, Komenského 73, 041 81 Košice, Slovakia.'}, {'ForeName': 'Beáta', 'Initials': 'B', 'LastName': 'Hubková', 'Affiliation': 'Department of Medical and Clinical Biochemistry, Faculty of Medicine, Pavol Jozef Šafárik University in Košice, Tr. SNP 1, 040 11 Košice, Slovakia.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Zábavníková', 'Affiliation': 'KOREKTCHIR s.r.o., Zborovská 7, 040 01 Košice, Slovakia.'}, {'ForeName': 'Mária', 'Initials': 'M', 'LastName': 'Mareková', 'Affiliation': 'Department of Medical and Clinical Biochemistry, Faculty of Medicine, Pavol Jozef Šafárik University in Košice, Tr. SNP 1, 040 11 Košice, Slovakia.'}]",International journal of molecular sciences,['10.3390/ijms22041884'] 3885,33255561,Maternal Docosahexaenoic Acid Status during Pregnancy and Its Impact on Infant Neurodevelopment.,"Dietary components are essential for the structural and functional development of the brain. Among these, docosahexaenoic acid, 22:6n-3 (DHA), is critically necessary for the structure and development of the growing fetal brain in utero . DHA is the major n-3 long-chain polyunsaturated fatty acid in brain gray matter representing about 15% of all fatty acids in the human frontal cortex. DHA affects neurogenesis, neurotransmitter, synaptic plasticity and transmission, and signal transduction in the brain. Data from human and animal studies suggest that adequate levels of DHA in neural membranes are required for maturation of cortical astrocyte, neurovascular coupling, and glucose uptake and metabolism. Besides, some metabolites of DHA protect from oxidative tissue injury and stress in the brain. A low DHA level in the brain results in behavioral changes and is associated with learning difficulties and dementia. In humans, the third trimester-placental supply of maternal DHA to the growing fetus is critically important as the growing brain obligatory requires DHA during this window period. Besides, DHA is also involved in the early placentation process, essential for placental development. This underscores the importance of maternal intake of DHA for the structural and functional development of the brain. This review describes DHA's multiple roles during gestation, lactation, and the consequences of its lower intake during pregnancy and postnatally on the 2019 brain development and function.",2020,"Among these, docosahexaenoic acid, 22:6n-3 (DHA), is critically necessary for the structure and development of the growing fetal brain in utero .",[],"['docosahexaenoic acid, 22:6n-3 (DHA']",['Maternal Docosahexaenoic Acid Status'],[],"[{'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.246439,"Among these, docosahexaenoic acid, 22:6n-3 (DHA), is critically necessary for the structure and development of the growing fetal brain in utero .","[{'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Basak', 'Affiliation': 'Molecular Biology Division, National Institute Nutrition, Indian Council of Medical Research, Hyderabad-500 007, India.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Mallick', 'Affiliation': 'Department of Biotechnology and Molecular Medicine, A.I. Virtanen Institute for Molecular Sciences, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'Asim K', 'Initials': 'AK', 'LastName': 'Duttaroy', 'Affiliation': 'Department of Nutrition, IMB, Faculty of Medicine, University of Oslo, 0317 Oslo, Norway.'}]",Nutrients,['10.3390/nu12123615'] 3886,33859955,Effects of Fermented Beverage in Subjects with Metabolic Syndrome.,"This study investigated the effects of fermented beverage, kale/apple juice containing 5% vinegar in subjects with metabolic syndrome. Subjects were randomly assigned to receive 250 mL fermented beverage or water containing fructose, glucose, and sucrose twice daily for 10 weeks. Consumption of the fermented beverage significantly decreased plasma triglyceride, thiobarbituric acid reactive substances (TBARS), tumor necrosis factor (TNF)-α, and high sensitivity C-reactive protein (hs-CRP) levels compared to baseline values ( P <0.05). Furthermore, consumption of the fermented beverage significantly decreased homeostasis model assessment for insulin resistance (HOMA-IR) values and atherogenic indexes compared with baseline values ( P <0.05). In the control group, plasma triglyceride, TBARS, TNF-α, and hs-CRP levels, atherogenic indexes, and HOMA-IR values did not significantly differ pre-and post-treatment. The fermented beverage inhibited the activities of α-glucosidase and pancreatic lipase in vitro , therefore could be helpful in alleviating metabolic syndrome in subjects with metabolic syndrome.",2021,"Consumption of the fermented beverage significantly decreased plasma triglyceride, thiobarbituric acid reactive substances (TBARS), tumor necrosis factor (TNF)-α, and high sensitivity C-reactive protein (hs-CRP) levels compared to baseline values ( P <0.05).","['subjects with metabolic syndrome', 'Subjects with Metabolic Syndrome']","['250 mL fermented beverage or water containing fructose, glucose, and sucrose twice daily for 10 weeks', 'fermented beverage, kale/apple juice containing 5% vinegar', 'Fermented Beverage']","['homeostasis model assessment for insulin resistance (HOMA-IR) values and atherogenic indexes', 'plasma triglyceride, thiobarbituric acid reactive substances (TBARS), tumor necrosis factor (TNF)-α, and high sensitivity C-reactive protein (hs-CRP) levels', 'plasma triglyceride, TBARS, TNF-α, and hs-CRP levels, atherogenic indexes, and HOMA-IR values']","[{'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C5200694', 'cui_str': 'Fermented Beverages'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0330498', 'cui_str': 'Brassica oleracea'}, {'cui': 'C0452454', 'cui_str': 'Apple juice'}, {'cui': 'C0148405', 'cui_str': 'Vinegar'}]","[{'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0583329', 'cui_str': 'Plasma triglyceride measurement'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}]",,0.026956,"Consumption of the fermented beverage significantly decreased plasma triglyceride, thiobarbituric acid reactive substances (TBARS), tumor necrosis factor (TNF)-α, and high sensitivity C-reactive protein (hs-CRP) levels compared to baseline values ( P <0.05).","[{'ForeName': 'Min-Ju', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': 'Bio-Food Research Center, Hurom Co., Ltd., Gyeongnam 50969, Korea.'}, {'ForeName': 'Jung-In', 'Initials': 'JI', 'LastName': 'Kim', 'Affiliation': 'Institute of Digital Anti-Aging Healthcare, Inje University, Gyeongnam 50834, Korea.'}, {'ForeName': 'Chung-Ho', 'Initials': 'CH', 'LastName': 'Ryu', 'Affiliation': 'Department of Agriculture Chemistry and Food Science and Technology, Institute of Agriculture and Life Science, Gyeongsang National University, Gyeongnam 52828, Korea.'}, {'ForeName': 'Min-Jung', 'Initials': 'MJ', 'LastName': 'Kang', 'Affiliation': 'Bio-Food Research Center, Hurom Co., Ltd., Gyeongnam 50969, Korea.'}]",Preventive nutrition and food science,['10.3746/pnf.2021.26.1.12'] 3887,33859840,A Simple Nomogram to Predict Contrast-Induced Acute Kidney Injury in Patients with Congestive Heart Failure Undergoing Coronary Angiography.,"Background Patients with congestive heart failure (CHF) are vulnerable to contrast-induced kidney injury (CI-AKI), but few prediction models are currently available. Therefore, we aimed to establish a simple nomogram for CI-AKI risk assessment for patients with CHF undergoing coronary angiography. Methods A total of 1876 consecutive patients with CHF (defined as New York Heart Association functional class II-IV or Killip class II-IV) were enrolled and randomly (2:1) assigned to a development cohort and a validation cohort. The endpoint was CI-AKI defined as serum creatinine elevation of ≥0.3 mg/dL or 50% from baseline within the first 48-72 hours following the procedure. Predictors for the simple nomogram were selected by multivariable logistic regression with a stepwise approach. The discriminative power was assessed using the area under the receiver operating characteristic (ROC) curve and was compared with the classic Mehran score in the validation cohort. Calibration was assessed using the Hosmer-Lemeshow test and 1000 bootstrap samples. Results The incidence of CI-AKI was 9.06% (170) in the total sample, 8.64% ( n  = 109) in the development cohort, and 9.92% ( n  = 61) in the validation cohort ( P =0.367). The simple nomogram including four predictors (age, intra-aortic balloon pump, acute myocardial infarction, and chronic kidney disease) demonstrated a similar predictive power as the Mehran score (area under the curve: 0.80 vs. 0.75, P =0.061), as well as a well-fitted calibration curve. Conclusions The present simple nomogram including four predictors is a simple and reliable tool to identify CHF patients at risk of CI-AKI, whereas further external validations are needed.",2021,"The incidence of CI-AKI was 9.06% (170) in the total sample, 8.64% ( n  = 109) in the development cohort, and 9.92% ( n  = 61) in the validation cohort ( P =0.367).","['1876 consecutive patients with CHF (defined as New York Heart Association functional class II-IV or Killip class II-IV', 'Patients with Congestive Heart Failure', '\n\n\nPatients with congestive heart failure (CHF', 'patients with CHF undergoing coronary angiography']",['Undergoing Coronary Angiography'],"['CI-AKI defined as serum creatinine elevation', 'incidence of CI-AKI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]","[{'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]","[{'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",1876.0,0.0625839,"The incidence of CI-AKI was 9.06% (170) in the total sample, 8.64% ( n  = 109) in the development cohort, and 9.92% ( n  = 61) in the validation cohort ( P =0.367).","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Lei', 'Affiliation': 'The Second School of Clinical Medicine, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yibo', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': ""Department of Cardiology, Provincial Key Laboratory of Coronary Heart Disease, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital Affiliated with South China University of Technology, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China.""}, {'ForeName': 'Zhaodong', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': ""Department of Cardiology, Provincial Key Laboratory of Coronary Heart Disease, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital Affiliated with South China University of Technology, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China.""}, {'ForeName': 'Bowen', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': ""Guangdong Provincial People's Hospital, School of Medicine, South China University of Technology, Guangzhou, Guangdong, China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, Provincial Key Laboratory of Coronary Heart Disease, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital Affiliated with South China University of Technology, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China.""}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Nie', 'Affiliation': ""Department of Cardiology, Provincial Key Laboratory of Coronary Heart Disease, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital Affiliated with South China University of Technology, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China.""}, {'ForeName': 'Guanzhong', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': ""Guangdong Provincial People's Hospital, School of Medicine, South China University of Technology, Guangzhou, Guangdong, China.""}, {'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'The Second School of Clinical Medicine, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Mengfei', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': ""Department of Cardiology, Maoming People's Hospital, Maoming, Guangdong, China.""}, {'ForeName': 'Wenhe', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': ""Department of Cardiology, Maoming People's Hospital, Maoming, Guangdong, China.""}, {'ForeName': 'Shiqun', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiology, Provincial Key Laboratory of Coronary Heart Disease, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital Affiliated with South China University of Technology, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China.""}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Jiyan', 'Affiliation': 'The Second School of Clinical Medicine, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'The Second School of Clinical Medicine, Southern Medical University, Guangzhou, Guangdong, China.'}]",Cardiology research and practice,['10.1155/2021/9614953'] 3888,33859826,Effect of age on dexmedetomidine treatment for ventilated patients with sepsis: a post-hoc analysis of the DESIRE trial.,"Aim There are no definitive data to determine whether age influences the effects of dexmedetomidine (DEX) treatment. Thus, we investigated whether older age was associated with more favorable sedative action by DEX in sepsis patients who required mechanical ventilation. Methods This study involved a post-hoc analysis of data from the Dexmedetomidine for Sepsis in the ICU Randomized Evaluation (DESIRE) trial. The patients were categorized based on median age into elderly and younger groups. The two groups were then compared during the first 7 days after ventilation based on proportion of patients with well-controlled sedation (Richmond Agitation-Sedation Scale score between -3 and +1), days free from delirium (based on the Confusion Assessment Method for ICU), and days free from coma (Richmond Agitation-Sedation Scale score between -4 and -5). Results One hundred and one patients were assigned to the elderly group and 100 patients were assigned to the younger group. In the elderly group, 50 patients received DEX treatment and 51 patients received non-DEX treatment, with the DEX arm having significantly better-controlled sedation (range, 14-52% versus 16-27%; P  = 0.01). In the younger group, 50 patients received DEX treatment and 50 patients received non-DEX treatment, with no significant difference in the proportions of well-controlled sedation (range, 20-64% versus 24-60%; P  = 0.73). There were no significant differences in the numbers of days free from delirium or coma between the groups. Conclusion In elderly sepsis patients who require ventilation, dexmedetomidine could be more effective than other sedative agents for achieving proper sedation.",2021,"There were no significant differences in the numbers of days free from delirium or coma between the groups. ","['One hundred and one patients were assigned to the elderly group and 100 patients were assigned to the younger group', 'ventilated patients with sepsis', 'sepsis patients who required mechanical ventilation', 'elderly sepsis patients', 'patients were categorized based on median age into elderly and younger groups']","['Dexmedetomidine', 'dexmedetomidine', 'non-DEX', 'dexmedetomidine (DEX', 'DEX']","['controlled sedation', 'proportions of well-controlled sedation', 'numbers of days free from delirium or coma']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0009421', 'cui_str': 'Coma'}]",101.0,0.0402095,"There were no significant differences in the numbers of days free from delirium or coma between the groups. ","[{'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Department of Emergency and Critical Care Medicine Tohoku University Hospital Sendai Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Kawazoe', 'Affiliation': 'Division of Emergency and Critical Care Medicine Tohoku University Graduate School of Medicine Sendai Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Miyagawa', 'Affiliation': 'Emergency and Critical Care Department Sendai City Hospital Sendai Japan.'}, {'ForeName': 'Yuta', 'Initials': 'Y', 'LastName': 'Yokokawa', 'Affiliation': 'Department of Emergency and Critical Care Medicine Tohoku University Hospital Sendai Japan.'}, {'ForeName': 'Shigeki', 'Initials': 'S', 'LastName': 'Kushimoto', 'Affiliation': 'Division of Emergency and Critical Care Medicine Tohoku University Graduate School of Medicine Sendai Japan.'}, {'ForeName': 'Kyohei', 'Initials': 'K', 'LastName': 'Miyamoto', 'Affiliation': 'Department of Emergency and Critical Care Medicine Wakayama Medical University Wakayama Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Ohta', 'Affiliation': 'Education and Training Center for Students and Professionals in Healthcare Hyogo College of Medicine Nishinomiya Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Morimoto', 'Affiliation': 'Department of Clinical Epidemiology Hyogo College of Medicine Nishinomiya Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Yamamura', 'Affiliation': 'Osaka Prefectural Nakakawachi Emergency and Critical Care Center Higashiosaka Japan.'}]",Acute medicine & surgery,['10.1002/ams2.644'] 3889,33859833,Clinical Comparison of the Performance of Two Marketed Ophthalmic Viscoelastic Devices (OVDs): The Bacterially Derived Healon PRO OVD and Animal-Derived Healon OVD.,"This clinical investigation compared the clinical performance of two marketed ophthalmic viscoelastic devices (OVDs): the bacterially derived Healon PRO OVD (test) and the animal-derived Healon OVD (control) under normal use conditions during cataract removal and lens implantation. This prospective, multicenter, randomized, parallel, participant/evaluator masked, postmarket investigation enrolled 139 subjects (170 eyes), 116 (143 eyes) of which were treated (73 test; 70 control group). Both test and control OVDs were used, at a minimum, to inflate the anterior chamber and protect the endothelium prior to cataract extraction according to the standard procedure. The surgeon completed a postsurgery OVD clinical performance questionnaire, and intraocular pressure (IOP) was measured before surgery and at the 1 day postoperative visit with Goldmann applanation tonometry. Any IOP measurement of 30 mmHg or higher was considered a ""spike"" and recorded as a study-specific, serious adverse event. The bacterially derived Healon PRO OVD was found to be statistically noninferior to the overall clinical performance of the animal-derived Healon OVD control; thus, the primary hypothesis was satisfied. There were no statistically significant differences between OVD groups for any of the additional endpoints relating to IOP changes or to safety, thus satisfying additional hypotheses. The Healon PRO OVD showed statistically significant improvements in surgeon ratings for ease of injectability, transparency/visibility, and ease of IOL placement. The safety profile was also similar between OVD groups with regards to serious and/or device-related adverse events, as well as medical and lens findings. The results of this clinical investigation support the safety and effectiveness of the bacterially derived, currently marketed Healon PRO OVD and indicate that the intraocular surgical performance was similar between the two OVDs.",2020,"There were no statistically significant differences between OVD groups for any of the additional endpoints relating to IOP changes or to safety, thus satisfying additional hypotheses.","['139 subjects (170 eyes), 116 (143 eyes) of which were treated (73 test; 70 control group']","['marketed ophthalmic viscoelastic devices (OVDs', 'Two Marketed Ophthalmic Viscoelastic Devices (OVDs']","['intraocular surgical performance', 'postsurgery OVD clinical performance questionnaire, and intraocular pressure (IOP', 'safety profile', 'surgeon ratings for ease of injectability, transparency/visibility, and ease of IOL placement']","[{'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1318228', 'cui_str': 'Market'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C1522223', 'cui_str': 'Intraocular route'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0522503', 'cui_str': 'Translucent'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",139.0,0.0753677,"There were no statistically significant differences between OVD groups for any of the additional endpoints relating to IOP changes or to safety, thus satisfying additional hypotheses.","[{'ForeName': 'Loay', 'Initials': 'L', 'LastName': 'Daas', 'Affiliation': 'Department of Ophthalmology, Saarland University Medical Center UKS, Homburg, Saar, Germany.'}, {'ForeName': 'Jose Manuel', 'Initials': 'JM', 'LastName': 'Larrosa', 'Affiliation': 'Hospital Provincial de Nuestra Señora de Garcia, Zaragoza, Spain.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Gavin', 'Affiliation': 'Hospital Provincial de Nuestra Señora de Garcia, Zaragoza, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Isanta', 'Affiliation': 'Hospital Provincial de Nuestra Señora de Garcia, Zaragoza, Spain.'}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Langenbucher', 'Affiliation': 'Institute of Experimental Ophthalmology, Saarland University, Homburg, Saar, Germany.'}, {'ForeName': 'Beth E', 'Initials': 'BE', 'LastName': 'Jackson', 'Affiliation': 'Johnson & Johnson Surgical Vision Inc., Santa Ana, CA, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Tsai', 'Affiliation': 'Johnson & Johnson Surgical Vision Inc., Santa Ana, CA, USA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Janakiraman', 'Affiliation': 'Johnson & Johnson Surgical Vision Inc., Santa Ana, CA, USA.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Guerrero', 'Affiliation': 'Johnson & Johnson Surgical Vision Inc., Santa Ana, CA, USA.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Seitz', 'Affiliation': 'Department of Ophthalmology, Saarland University Medical Center UKS, Homburg, Saar, Germany.'}]",Journal of ophthalmology,['10.1155/2020/8874850'] 3890,33859829,Controlled human exposures to diesel exhaust: a human epigenome-wide experiment of target bronchial epithelial cells.,"Diesel exhaust (DE) is a major contributor to ambient air pollution around the world. It is a known human carcinogen that targets the respiratory system and increases risk for many diseases, but there is limited research on the effects of DE exposure on the epigenome of human bronchial epithelial cells. Understanding the epigenetic impact of this environmental pollutant can elucidate biological mechanisms involved in the pathogenesis of harmful DE-related health effects. To estimate the causal effect of short-term DE exposure on the bronchial epithelial epigenome, we conducted a controlled single-blinded randomized crossover human experiment of exposure to DE and used bronchoscopy and Illumina 450K arrays for data collection and analysis, respectively. Of the 13 participants, 11 (85%) were male and 2 (15%) were female, and 12 (92%) were White and one (8%) was Hispanic; the mean age was 26 years (SD = 3.8 years). Eighty CpGs were differentially methylated, achieving the minimum possible exact P -value of P  =   2.44 × 10 -4 ( i.e. 2/2 13 ). In regional analyses, we found two differentially methylated regions (DMRs) annotated to the chromosome 5 open reading frame 63 genes ( C5orf63 ; 7-CpGs) and unc-45 myosin chaperone A gene ( UNC45A ; 5-CpGs). Both DMRs showed increased DNA methylation after DE exposure. The average causal effects for the DMRs ranged from 1.5% to 6.0% increases in DNA methylation at individual CpGs. In conclusion, we found that short-term DE alters DNA methylation of genes in target bronchial epithelial cells, demonstrating epigenetic level effects of exposure that could be implicated in pulmonary pathologies.",2021,"Eighty CpGs were differentially methylated, achieving the minimum possible exact P -value of P  ","['13 participants, 11 (85%) were male and 2 (15%) were female, and 12 (92%) were White and one (8%) was Hispanic', ' the mean age was 26\u2009years (SD\u2009=\u20093.8 years', 'bronchial epithelial epigenome']",['Diesel exhaust (DE'],['DNA methylation'],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205039', 'cui_str': 'Bronchial'}, {'cui': 'C4727083', 'cui_str': 'Methylome'}]","[{'cui': 'C0012151', 'cui_str': 'Diesel Exhaust'}]","[{'cui': 'C0376452', 'cui_str': 'DNA Methylation'}]",80.0,0.0905305,"Eighty CpGs were differentially methylated, achieving the minimum possible exact P -value of P  ","[{'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Cardenas', 'Affiliation': 'Division of Environmental Health Sciences, School of Public Health, University of California, Berkeley; Berkeley, CA 94704, USA.'}, {'ForeName': 'Raj P', 'Initials': 'RP', 'LastName': 'Fadadu', 'Affiliation': 'Division of Environmental Health Sciences, School of Public Health, University of California, Berkeley; Berkeley, CA 94704, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Van Der Laan', 'Affiliation': 'Division of Environmental Health Sciences, School of Public Health, University of California, Berkeley; Berkeley, CA 94704, USA.'}, {'ForeName': 'Cavin', 'Initials': 'C', 'LastName': 'Ward-Caviness', 'Affiliation': 'Public Health and Integrated Toxicology Division, Center for Public Health and Environmental Assessment, US Environmental Protection Agency, Chapel Hill, NC 27709, USA.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Granger', 'Affiliation': 'Department of Statistics, Faculty of Arts and Sciences, Harvard University, Cambridge, MA 02138, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Diaz-Sanchez', 'Affiliation': 'Public Health and Integrated Toxicology Division, Center for Public Health and Environmental Assessment, US Environmental Protection Agency, Chapel Hill, NC 27709, USA.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Devlin', 'Affiliation': 'Public Health and Integrated Toxicology Division, Center for Public Health and Environmental Assessment, US Environmental Protection Agency, Chapel Hill, NC 27709, USA.'}, {'ForeName': 'Marie-Abèle', 'Initials': 'MA', 'LastName': 'Bind', 'Affiliation': 'Department of Statistics, Faculty of Arts and Sciences, Harvard University, Cambridge, MA 02138, USA.'}]",Environmental epigenetics,['10.1093/eep/dvab003'] 3891,33859712,The Feasibility and Positive Effects of Wuqinxi Exercise on the Cognitive and Motor Functions of Patients with Parkinson's Disease: A Pilot Study.,"Introduction Parkinson's disease (PD) is a chronic degenerative disease of the central nervous system common in middle-aged and elderly people, which has a serious impact on patients' cognitive and motor functions. Exercise can improve the nonmotor symptoms of PD patients, but the optimal type of exercise for the cognitive function of patients is unclear. Therefore, the purpose of this study is the impact of 12 weeks of Wuqinxi exercise on the cognitive and motor function in PD patients. Methods Thirty PD patients participated in the study and were randomly assigned to two groups: Wuqinxi group ( n  = 15) or stretching group ( n  = 15). All the participants performed a 12-week exercise program twice a week, 90 min/session. The assessments were conducted before and after exercise intervention, included cognitive function (frontal assessment battery (FAB); Stroop test I and II), motor functions (Unified Parkinson's Disease Rating Scale Part III (UPDRS-III); timed up and go (TUG)). Results We found the FAB and Stroop I scores were significantly higher in the Wuqinxi group than in the stretching group. Participants in the Wuqinxi group significantly improved their UPDRS-III (17.73 ± 9.88) and TUG (10.50 ± 1.79) score after 12 weeks of training intervention. Conclusion The results show that the use of Wuqinxi for rehabilitation therapy for cognition is feasible, widely accepted, and effective in patients with Parkinson's disease. This study provides preliminary evidence for further large-scale and controlled studies.",2021,We found the FAB and Stroop I scores were significantly higher in the Wuqinxi group than in the stretching group.,"['PD patients', ""Patients with Parkinson's Disease"", ""patients with Parkinson's disease"", 'Methods\n\n\nThirty PD patients participated in the study', 'middle-aged and elderly people']","['Wuqinxi Exercise', 'Wuqinxi exercise', 'Wuqinxi group ( n \u2009=\u200915) or stretching group', 'Wuqinxi']","[""Stroop test I and II), motor functions (Unified Parkinson's Disease Rating Scale Part III (UPDRS-III); timed up and go (TUG"", 'cognitive function (frontal assessment battery (FAB', 'Cognitive and Motor Functions', 'cognitive and motor function', 'FAB and Stroop I scores', 'UPDRS-III']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}]","[{'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C2732353', 'cui_str': 'Frontal assessment battery'}, {'cui': 'C0021031', 'cui_str': 'Immunoglobulin, F(ab) fragment'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0224435,We found the FAB and Stroop I scores were significantly higher in the Wuqinxi group than in the stretching group.,"[{'ForeName': 'Mengyue', 'Initials': 'M', 'LastName': 'Shen', 'Affiliation': 'School of Martial Arts, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Yan-Ling', 'Initials': 'YL', 'LastName': 'Pi', 'Affiliation': 'Shanghai Punan Hosptial of Pudong New District, Shanghai, China.'}, {'ForeName': 'Zhenlan', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'School of Sport Science, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Song', 'Affiliation': 'School of Sport Science, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Kuncheng', 'Initials': 'K', 'LastName': 'Jie', 'Affiliation': 'School of Martial Arts, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'School of Sport Science, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': 'School of Martial Arts, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhuang', 'Affiliation': 'School of Sport Science, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'School of Martial Arts, Shanghai University of Sport, Shanghai, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2021/8833736'] 3892,33859707,Perioperative Electroacupuncture Can Accelerate the Recovery of Gastrointestinal Function in Cancer Patients Undergoing Pancreatectomy or Gastrectomy: A Randomized Controlled Trial.,"The effect of perioperative acupuncture on accelerating gastrointestinal function recovery has been reported in colorectal surgery and distal gastrectomy (Billroth-II). However, the evidence in pancreatectomy and other gastrectomy is still limited. A prospective, randomized controlled trial was conducted between May 2018 and August 2019. Consecutive patients undergoing pancreatectomy or gastrectomy in our hospital were randomly assigned to the electroacupuncture (EA) group and the control group. The patients in the EA group received transcutaneous EA on Bai-hui (GV20), Nei-guan (PC6), Tian-shu (ST25), and Zu-san-li (ST36) once a day in the afternoon, and the control group received sham EA. Primary outcomes were the time to first flatus and time to first defecation. In total, 461 patients were randomly assigned to the groups, and 385 were analyzed finally (EA group, n  = 201; control group, n  = 184). Time to first flatus (3.0 ± 0.7 vs 4.2 ± 1.0, P < 0.001) and first defecation (4.2 ± 0.9 vs 5.4 ± 1.2, P < 0.001) in the EA group were significantly shorter than those in the control group. Of patients undergoing pancreatectomy, those undergoing pancreaticoduodenectomy and intraoperative radiation therapy (IORT) surgery benefitted from EA in time to first flatus ( P < 0.001) and first defecation ( P < 0.001), while those undergoing distal pancreatectomy did not ( P flatus =0.157, P defecation =0.007) completely. Of patients undergoing gastrectomy, those undergoing total gastrectomy and distal gastrectomy (Billroth-II) benefitted from EA ( P < 0.001), as did those undergoing proximal gastrectomy ( P =0.015). Patients undergoing distal gastrectomy (Billroth-I) benefitted from EA in time to first defecation ( P =0.012) but not flatus ( P =0.051). The time of parenteral nutrition, hospital stay, and time to first independent walk in the EA group were shorter than those in the control group. No severe EA complications were reported. EA was safe and effective in accelerating postoperative gastrointestinal function recovery. Patients undergoing pancreaticoduodenectomy, IORT surgery, total gastrectomy, proximal gastrectomy, or distal gastrectomy (Billroth-II) could benefit from EA. This trial is registered with NCT03291574.",2021,"The time of parenteral nutrition, hospital stay, and time to first independent walk in the EA group were shorter than those in the control group.","['Patients undergoing', 'Consecutive patients undergoing pancreatectomy or gastrectomy in our hospital', 'May 2018 and August 2019', 'Patients undergoing distal gastrectomy (Billroth-I', '461 patients were randomly assigned to the groups, and 385 were analyzed finally (EA group, n \u2009=\u2009201; control group, n \u2009=\u2009184', 'Cancer Patients Undergoing Pancreatectomy or Gastrectomy', 'colorectal surgery and distal gastrectomy (Billroth-II']","['pancreaticoduodenectomy, IORT surgery, total gastrectomy, proximal gastrectomy, or distal gastrectomy (Billroth-II', 'Perioperative Electroacupuncture', 'transcutaneous EA on Bai-hui (GV20), Nei-guan (PC6), Tian-shu (ST25), and Zu-san-li (ST36) once a day in the afternoon, and the control group received sham EA', 'perioperative acupuncture', 'electroacupuncture (EA', 'EA', 'pancreaticoduodenectomy and intraoperative radiation therapy (IORT) surgery']","['time of parenteral nutrition, hospital stay, and time to first independent walk', 'first defecation', 'severe EA complications', 'total gastrectomy and distal gastrectomy', 'Recovery of Gastrointestinal Function', 'time to first flatus and time to first defecation', 'Time to first flatus']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030279', 'cui_str': 'Pancreatectomy'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0192440', 'cui_str': 'Distal subtotal gastrectomy'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517751', 'cui_str': '385'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0192444', 'cui_str': 'Resection of stomach with gastrojejunal anastomosis'}]","[{'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0338240', 'cui_str': 'Intraoperative radiation therapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0161899', 'cui_str': 'Total gastrectomy'}, {'cui': 'C0399713', 'cui_str': 'Proximal subtotal gastrectomy'}, {'cui': 'C0192440', 'cui_str': 'Distal subtotal gastrectomy'}, {'cui': 'C0192444', 'cui_str': 'Resection of stomach with gastrojejunal anastomosis'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C1955969', 'cui_str': 'National Eye Institute'}, {'cui': 'C0325602', 'cui_str': 'Guan'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0439550', 'cui_str': 'Afternoon'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0161899', 'cui_str': 'Total gastrectomy'}, {'cui': 'C0192440', 'cui_str': 'Distal subtotal gastrectomy'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}]",461.0,0.133513,"The time of parenteral nutrition, hospital stay, and time to first independent walk in the EA group were shorter than those in the control group.","[{'ForeName': 'Guotong', 'Initials': 'G', 'LastName': 'Qiu', 'Affiliation': 'State Key Lab of Molecular Oncology and Department of Pancreatic and Gastric Surgery, National Cancer Center, National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Huang', 'Affiliation': 'Department of Ophthalmology, Acupuncture and Moxibustion Hospital of China Academy of Chinese Medicine Science, Beijing 100700, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Graduate School, Liaoning University of Traditional Chinese Medicine, Shenyang 110847, Liaoning, China.'}, {'ForeName': 'Lipeng', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'State Key Lab of Molecular Oncology and Department of Pancreatic and Gastric Surgery, National Cancer Center, National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'Yajie', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'State Key Lab of Molecular Oncology and Department of Pancreatic and Gastric Surgery, National Cancer Center, National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Ophthalmology, Acupuncture and Moxibustion Hospital of China Academy of Chinese Medicine Science, Beijing 100700, China.'}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Ren', 'Affiliation': 'State Key Lab of Molecular Oncology and Department of Pancreatic and Gastric Surgery, National Cancer Center, National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'An', 'Affiliation': 'Donggaodi Community Health Service Station, Beijing 100076, China.'}, {'ForeName': 'Jincao', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Ophthalmology, Acupuncture and Moxibustion Hospital of China Academy of Chinese Medicine Science, Beijing 100700, China.'}, {'ForeName': 'Rongjun', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology, Acupuncture and Moxibustion Hospital of China Academy of Chinese Medicine Science, Beijing 100700, China.'}, {'ForeName': 'Yongxing', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'State Key Lab of Molecular Oncology and Department of Pancreatic and Gastric Surgery, National Cancer Center, National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'Tuoran', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, Acupuncture and Moxibustion Hospital of China Academy of Chinese Medicine Science, Beijing 100700, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'State Key Lab of Molecular Oncology and Department of Pancreatic and Gastric Surgery, National Cancer Center, National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'He', 'Affiliation': 'State Key Lab of Molecular Oncology and Department of Pancreatic and Gastric Surgery, National Cancer Center, National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'Yunqing', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Graduate School, Liaoning University of Traditional Chinese Medicine, Shenyang 110847, Liaoning, China.'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'State Key Lab of Molecular Oncology and Department of Pancreatic and Gastric Surgery, National Cancer Center, National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Han', 'Affiliation': 'Department of Ophthalmology, Acupuncture and Moxibustion Hospital of China Academy of Chinese Medicine Science, Beijing 100700, China.'}, {'ForeName': 'Zhongmin', 'Initials': 'Z', 'LastName': 'Lan', 'Affiliation': 'State Key Lab of Molecular Oncology and Department of Pancreatic and Gastric Surgery, National Cancer Center, National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'Shulan', 'Initials': 'S', 'LastName': 'Qi', 'Affiliation': 'Department of Ophthalmology, Acupuncture and Moxibustion Hospital of China Academy of Chinese Medicine Science, Beijing 100700, China.'}, {'ForeName': 'Zongze', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'State Key Lab of Molecular Oncology and Department of Pancreatic and Gastric Surgery, National Cancer Center, National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'Jianyong', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Binzhou Hospital of Traditional Chinese Medicine, Binzhou 251800, Shandong, China.'}, {'ForeName': 'Zongting', 'Initials': 'Z', 'LastName': 'Gu', 'Affiliation': 'State Key Lab of Molecular Oncology and Department of Pancreatic and Gastric Surgery, National Cancer Center, National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'Yuemin', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'State Key Lab of Molecular Oncology and Department of Pancreatic and Gastric Surgery, National Cancer Center, National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Bai', 'Affiliation': 'State Key Lab of Molecular Oncology and Department of Pancreatic and Gastric Surgery, National Cancer Center, National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'Saderbieke', 'Initials': 'S', 'LastName': 'Aimaiti', 'Affiliation': 'State Key Lab of Molecular Oncology and Department of Pancreatic and Gastric Surgery, National Cancer Center, National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'Yunmian', 'Initials': 'Y', 'LastName': 'Chu', 'Affiliation': 'State Key Lab of Molecular Oncology and Department of Pancreatic and Gastric Surgery, National Cancer Center, National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'Chengfeng', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'State Key Lab of Molecular Oncology and Department of Pancreatic and Gastric Surgery, National Cancer Center, National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2021/5594263'] 3893,33859693,Gingivitis Effectiveness of Emulgel Containing 2% Resveratrol in Orthodontic Patients: An 8-Week Randomized Clinical Trial.,"Background Treatment of gingivitis in patients undergoing orthodontic treatment is done through different methods. Anti-inflammatory agents present in toothpaste or mouthwash are applied spontaneously by patients or used as professional treatment protocols. The present study aimed to investigate the gingivitis effectiveness of Emulgel containing 2% resveratrol in orthodontic patients. Methods The study was conducted in three groups, namely, experimental, placebo, and control. In the experimental group, participants used an Emulgel containing 2% resveratrol. In the placebo group, subjects used an identical Emulgel without the active components in the test formulations. After brushing their teeth, the participants learned how to use 5 ml of Emulgel on the gums and massage every night for 30 s. In the control group, subjects were instructed to massage their gums for 30 s every night without any product. Evaluated criteria included bleeding on probing (BOP), gingival index (GI), hyperplastic index (HI), and probing pocket depth (PPD). Result During 4 and 8 weeks of the study, the PPD score in the control group did not change significantly but decreased in both groups. Also, there was a decrease in the PPD score in the experimental group compared to the placebo and control groups. Similarly, in the experimental group, continuous use of Emulgel containing 2% resveratrol reduced the HI and GI scores significantly at 4 and 8 weeks after the start of the study. Here, the decrease in GI and HI scores in the experimental group was higher than that of the other groups. Conclusions The Emulgel containing 2% resveratrol is effective in improving gingival health in orthodontic patients and can lower gingival inflammation over 8 weeks. This trial is registered with the Iranian registry of clinical trials (https://irct.ir/) IRCT20130812014333N91.",2021,"During 4 and 8 weeks of the study, the PPD score in the control group did not change significantly but decreased in both groups.","['orthodontic patients', 'patients undergoing orthodontic treatment', 'Orthodontic Patients']","['placebo', 'massage their gums for 30\u2009s every night without any product', 'Emulgel Containing 2% Resveratrol']","['gingival health', 'bleeding on probing (BOP), gingival index (GI), hyperplastic index (HI), and probing pocket depth (PPD', 'gingival inflammation', 'PPD score', 'GI and HI scores', 'gingivitis effectiveness', 'HI and GI scores', 'Gingivitis Effectiveness']","[{'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C1720374', 'cui_str': 'Every'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0073096', 'cui_str': 'resveratrol'}]","[{'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008684', 'cui_str': 'Chronic gingivitis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0783694,"During 4 and 8 weeks of the study, the PPD score in the control group did not change significantly but decreased in both groups.","[{'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Golshah', 'Affiliation': 'Department of Orthodontic, School of Dentistry, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Shahla', 'Initials': 'S', 'LastName': 'Mirzaeei', 'Affiliation': 'Pharmaceutical Sciences Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Nafiseh', 'Initials': 'N', 'LastName': 'Nikkerdar', 'Affiliation': 'Department of Maxillofacial Radiology, School of Dentistry, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Ghorbani', 'Affiliation': 'Department of Orthodontic, School of Dentistry, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}]",International journal of dentistry,['10.1155/2021/6615900'] 3894,33859685,Acute Effects of Ketamine Infusion on Postoperative Mood Scores in Patients Undergoing Dilation and Curettage: A Randomized Double-Blind Controlled Study.,"Background Emotional and psychological effects following abortion are more common than physical side effects and can range from mild regret to more serious complications such as depression. In the last decade, it has been suggested that low dose of ketamine is a fast-acting antidepressant. Purpose The aim of this study was to investigate the impact of intraoperative ketamine infusion on postoperative mood score in patients undergoing Dilation and Curettage (D&C) under spinal anesthesia. We hypothesized that a single low-dose administration of ketamine infusion during D&C surgery can improve mood scores in the immediate postoperative period. Methods A prospective, randomized, double-blind, parallel-group, placebo-controlled trial. The study included a total of 60 patients, ≥18 years, physical status ASA II, with up to 12-week gestation undergoing elective D&C surgery. Patients were divided randomly into a ketamine group (group K) and a control group (group C). In group K, 0.4 mg/kg ketamine was given as a continuous infusion over 20 min intraoperatively. Main Outcome Measure . Profile of Mood States (POMS) was recorded preoperatively and 2 hours postoperatively. Results There were no differences in preoperative POMS between the two groups. Mean postoperative POMS of group K was lower than that of group C indicating mood improvement. Ketamine group patients showed higher sedation score and increased, although self-limiting, psychedelic phenomena than the control group. Conclusion Observed data here support an acute effect of ketamine on mood but any further claim will be speculative. Further future studies exploring postoperative mood scores after 24 hours post-infusion are needed. This trial is registered with PACTR201907779292947.",2021,"Ketamine group patients showed higher sedation score and increased, although self-limiting, psychedelic phenomena than the control group. ","['60 patients, ≥18 years, physical status ASA II, with up to 12-week gestation undergoing elective D&C surgery', 'Patients Undergoing Dilation and Curettage', 'patients undergoing Dilation and Curettage (D&C) under spinal anesthesia']","['Ketamine', 'intraoperative ketamine infusion', 'ketamine', 'placebo', 'Ketamine Infusion']","['Postoperative Mood Scores', 'Profile of Mood States (POMS', 'Mean postoperative POMS', 'preoperative POMS', 'higher sedation score', 'mood scores', 'postoperative mood scores', 'postoperative mood score', 'self-limiting, psychedelic phenomena']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0012358', 'cui_str': 'Dilation and curettage of uterus'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0018533', 'cui_str': 'Hallucinogen'}]",60.0,0.371732,"Ketamine group patients showed higher sedation score and increased, although self-limiting, psychedelic phenomena than the control group. ","[{'ForeName': 'Raham Hasan', 'Initials': 'RH', 'LastName': 'Mostafa', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Ahmed Mohamed', 'Initials': 'AM', 'LastName': 'Khamis', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Ashraf Nabil', 'Initials': 'AN', 'LastName': 'Saleh', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Yehia Mamdouh Hassan', 'Initials': 'YMH', 'LastName': 'Mekki', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Mohamed Mohamed', 'Initials': 'MM', 'LastName': 'Kamal', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Ismail Mohammed', 'Initials': 'IM', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Mohamed Abdulmohsen Abdulnaiem', 'Initials': 'MAA', 'LastName': 'Ismaiel', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Ain Shams University, Cairo, Egypt.'}]",Anesthesiology research and practice,['10.1155/2021/6674658'] 3895,33859606,Influence of Stochastic Resonance on Manual Dexterity in Children With Developmental Coordination Disorder: A Double-Blind Interventional Study.,"Background: There is increasing evidence that the stochastic resonance (SR) phenomenon provided by subthreshold mechanical noise stimulation improves the sensory-motor system. However, the effect of SR on children with developmental coordination disorder (DCD) is unclear. The purpose of this study was to assess whether SR activated by subthreshold vibrotactile noise stimulation of the wrist influences manual dexterity in children with DCD. Methods: A double-blind interventional study was conducted. Participants were 30 children (age: 9.3 ± 1.44 years, range 6-11 years; 27 male, three female; 25 right-handed, five left-handed) meeting DCD diagnostic criteria in DSM-5. The manual dexterity test was administered the day before SR intervention (baseline-data). SR was elicited using subthreshold vibrotactile noise stimulation at 60% of the vibrotactile threshold measured at the wrist. SR was delivered two times and the manual dexterity test was administered during each SR stimulation block (SR-on condition) and after each SR stimulation block (SR-off), for a total of four measurements. Target outcomes were the component score, the standard score, and the percentile score of the manual dexterity test. Results: The manual dexterity test scores in the SR-on condition were significantly improved compared to scores at the baseline and in the SR-off condition ( p < 0.001). Conclusions: The present study showed that subthreshold noise stimulation eliciting SR significantly improved manual dexterity outcomes in children with DCD during stimulation but not after stimulation. Future studies will need to investigate the carry-over effects of SR stimulation.",2021,The manual dexterity test scores in the SR-on condition were significantly improved compared to scores at the baseline and in the SR-off condition ( p < 0.001). ,"['children with DCD', 'Children With Developmental Coordination Disorder', 'Participants were 30 children (age: 9.3 ± 1.44 years, range 6-11 years; 27 male, three female; 25 right-handed, five left-handed) meeting DCD diagnostic criteria in DSM-5', 'children with developmental coordination disorder (DCD']","['SR activated by subthreshold vibrotactile noise stimulation', 'Stochastic Resonance', 'SR', 'subthreshold noise stimulation eliciting SR']","['percentile score of the manual dexterity test', 'Manual Dexterity', 'manual dexterity outcomes', 'manual dexterity test scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0608070', 'cui_str': 'dicarboxydine'}, {'cui': 'C0011757', 'cui_str': 'Developmental coordination disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C0234418', 'cui_str': 'Left handed'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}]","[{'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0231881', 'cui_str': 'Resonance'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}]","[{'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",30.0,0.211442,The manual dexterity test scores in the SR-on condition were significantly improved compared to scores at the baseline and in the SR-off condition ( p < 0.001). ,"[{'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Nobusako', 'Affiliation': 'Neurorehabilitation Research Center, Kio University , Kitakatsuragi-gun, Japan.'}, {'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Osumi', 'Affiliation': 'Neurorehabilitation Research Center, Kio University , Kitakatsuragi-gun, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Matsuo', 'Affiliation': 'Neurorehabilitation Research Center, Kio University , Kitakatsuragi-gun, Japan.'}, {'ForeName': 'Emi', 'Initials': 'E', 'LastName': 'Furukawa', 'Affiliation': 'Neurorehabilitation Research Center, Kio University , Kitakatsuragi-gun, Japan.'}, {'ForeName': 'Takaki', 'Initials': 'T', 'LastName': 'Maeda', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Sotaro', 'Initials': 'S', 'LastName': 'Shimada', 'Affiliation': 'Department of Electronics and Bioinformatics School of Science and Technology, Meiji University, Kawasaki, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Nakai', 'Affiliation': ""Graduate School of Clinical Education & The Center for the Study of Child Development, Institute for Education, Mukogawa Women's University, Nishinomiya, Japan.""}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Morioka', 'Affiliation': 'Neurorehabilitation Research Center, Kio University , Kitakatsuragi-gun, Japan.'}]",Frontiers in neurology,['10.3389/fneur.2021.626608'] 3896,33859576,"Effects of Resting vs. Continuous Blood-Flow Restriction-Training on Strength, Fatigue Resistance, Muscle Thickness, and Perceived Discomfort.","Introduction : The purpose of this study was to clarify whether blood-flow restriction during resting intervals [resting blood-flow restriction (rBFR)] is comparable to a continuous BFR (cBFR) training regarding its effects on maximum strength, hypertrophy, fatigue resistance, and perceived discomfort. Materials and Methods : Nineteen recreationally trained participants performed four sets (30-15-15-15 repetitions) with 20% 1RM on a 45° leg press twice a week for 6 weeks (cBFR, n = 10; rBFR, n = 9). Maximum strength, fatigue resistance, muscle thickness, and girth were assessed at three timepoints (pre, mid, and post). Subjective pain and perceived exertion were determined immediately after training at two timepoints (mid and post). Results : Maximum strength ( p < 0.001), fatigue resistance ( p < 0.001), muscle thickness ( p < 0.001), and girth ( p = 0.008) increased in both groups over time with no differences between groups ( p > 0.05). During the intervention, the rBFR group exposed significantly lower perceived pain and exertion values compared to cBFR ( p < 0.05). Discussion : Resting blood-flow restriction training led to similar gains in strength, fatigue resistance, and muscle hypertrophy as cBFR training while provoking less discomfort and perceived exertion in participants. In summary, rBFR training could provide a meaningful alternative to cBFR as this study showed similar functional and structural changes as well as less discomfort.",2021,"Resting blood-flow restriction training led to similar gains in strength, fatigue resistance, and muscle hypertrophy as cBFR training while provoking less discomfort and perceived exertion in participants.",['Discussion '],"['Resting vs. Continuous Blood-Flow Restriction-Training', 'blood-flow restriction during resting intervals [resting blood-flow restriction (rBFR', 'Materials and Methods ', 'continuous BFR (cBFR) training', 'rBFR training', 'Resting blood-flow restriction training']","['Maximum strength, fatigue resistance, muscle thickness, and girth', 'pain and exertion values', 'Maximum strength', 'Strength, Fatigue Resistance, Muscle Thickness, and Perceived Discomfort', 'fatigue resistance ', 'maximum strength, hypertrophy, fatigue resistance, and perceived discomfort', 'Subjective pain and perceived exertion', 'muscle thickness']","[{'cui': 'C0557061', 'cui_str': 'Discussion'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",,0.0163216,"Resting blood-flow restriction training led to similar gains in strength, fatigue resistance, and muscle hypertrophy as cBFR training while provoking less discomfort and perceived exertion in participants.","[{'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Schwiete', 'Affiliation': 'Department of Sports Medicine and Exercise Physiology, Institute of Sports Sciences, Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Franz', 'Affiliation': 'Department of Adult Reconstruction, ATOS Orthoparc Clinic Cologne, Cologne, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Roth', 'Affiliation': 'Department of Sports Medicine and Exercise Physiology, Institute of Sports Sciences, Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Behringer', 'Affiliation': 'Department of Sports Medicine and Exercise Physiology, Institute of Sports Sciences, Goethe University Frankfurt, Frankfurt am Main, Germany.'}]",Frontiers in physiology,['10.3389/fphys.2021.663665'] 3897,33859574,Supramaximal-Exercise Training Improves Heart Rate Variability in Association With Reduced Catecholamine in Obese Adults.,"This study investigates the effect of 6 weeks of supramaximal exercise training (SET) on heart rate variability (HRV) and associated factors in sedentary obese (OB) and normal-weight (NW) adults. In this study, 19 OB [22.9 (8.4) years; body mass index (BMI) 33.4 (1.4) kg/m 2 ] and 18 NW [23.2 (4.4) years; BMI 23.3 (1.2) kg/m 2 ] adults completed a 6-week SET intervention. Anthropometric and aerobic indicators as well the homeostasis model assessment index for insulin resistance index (HOMA-IR) were assessed at baseline and after SET. The low- and high-frequency [(LF (0.03-0.15 Hz) in ms 2 and HF (0.15-0.4 Hz) in ms 2 )] analysis of HRV as well as adrenaline (A in nmol/l) and noradrenaline (NA in nmol/l) responses were assessed at resting condition and during ventilatory threshold 1 (VT1) of a graded maximal test at baseline and after SET. At baseline, resting HF, LF and the LF/HF ratio were different among groups ( P < 0.01, respectively) and were significantly associated with waist-to-hip ratio (β = -0.26; p = 0.01, β = -0.12; p = 0.01 and, β = 0.21; p = 0.01). During exertion at VT1, only LF/HF ratio was associated with NA responses (β = 0.23; p = 0.01). After SET, the frequency domain marker improved significantly for both groups in comparison to baseline. These improvements are manifested by LF and HF increases and LF/HF ratio decreases in the rest condition ( p < 0.01, respectively) and during exertion at VT1 ( p < 0.01, respectively). The improvement in LH and HF were associated with VO 2 max increases (β = 0.22 p = 0.01 and β = 0.33; p = 0.01). The decreases observed for the LF/HF ratio are mainly associated to NA decreases observed at rest (β = 0.31; p = 0.001) and at VT1 (β = 0.38; p = 0.001). Obese adults have altered HRV, and 6 weeks of SET improves HRV variables at rest and during VT1 exertion. While LF and HF improvement were associated with VO2max increases, the LF/HF ratio was mainly associated with noradrenaline decreases observed at rest and at VT1.",2021,"At baseline, resting HF, LF and the LF/HF ratio were different among groups ( P < 0.01, respectively) and were significantly associated with waist-to-hip ratio (β = -0.26; p = 0.01, β = -0.12; p = 0.01 and, β = 0.21; ","['Obese Adults', 'Obese adults', 'sedentary obese (OB) and normal-weight (NW) adults', '19 OB [22.9 (8.4) years; body mass index (BMI) 33.4 (1.4) kg/m 2 ] and 18 NW [23.2 (4.4) years; BMI 23.3 (1.2) kg/m 2 ] adults completed a 6-week SET intervention']","['adrenaline ', 'noradrenaline (NA', 'Supramaximal-Exercise Training', 'supramaximal exercise training (SET']","['LH and HF', 'frequency domain marker', 'homeostasis model assessment index for insulin resistance index (HOMA-IR', 'LF/HF ratio', 'VO2max increases, the LF/HF ratio', 'heart rate variability (HRV', 'resting HF, LF and the LF/HF ratio', 'HRV variables', 'LF and HF increases and LF/HF ratio']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",19.0,0.0324575,"At baseline, resting HF, LF and the LF/HF ratio were different among groups ( P < 0.01, respectively) and were significantly associated with waist-to-hip ratio (β = -0.26; p = 0.01, β = -0.12; p = 0.01 and, β = 0.21; ","[{'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Jabbour', 'Affiliation': 'Physical Education Department, College of Education, Qatar University, Doha, Qatar.'}, {'ForeName': 'Horia D', 'Initials': 'HD', 'LastName': 'Iancu', 'Affiliation': 'School of Kinesiology and Leisure, University of Moncton, Moncton, NB, Canada.'}]",Frontiers in physiology,['10.3389/fphys.2021.654695'] 3898,33859572,Effects of a Short-Term Resistance-Training Program on Heart Rate Variability in Children With Cystic Fibrosis-A Randomized Controlled Trial.,"Background: Cystic fibrosis (CF) affects the autonomic nervous system (ANS) and exercise in healthy children modulates the interaction between sympathetic and parasympathetic activity. This study aimed to evaluate the effects of a short-term resistance exercise program on heart rate variability (HRV) in children and adolescents with CF. Methods: A randomized controlled trial was carried out in children diagnosed with CF aged 6-18 years. Individuals were divided into two groups: control (CON) and resistance-training (EX). Individuals in the EX group completed an individualized guided resistance program (5-RM-60-80%) for 8 weeks (3 sessions of 60 min/week). Upper and lower limbs exercises (seated bench press, seated lateral row, and leg press) were used. HRV was measured using a Suunto watch with subjects in lying position. Results: Nineteen subjects (13 boys) were included (CON = 11; and EX = 8). Mean age was 12.2 ± 3.3, FEV 1 (forced expiratory volume in the first second) z-score was 1.72 ± 1.54 and peak oxygen consumption (VO 2 peak) 42.7 ± 7.4 mL.Kg -1 .min -1 . Exercise induced significant changes in the frequency-domain variables, including a decrease in LF power ( p = 0.001, d = 0.98) and LF/HF ratio ( p = 0.020, d = 0.92), and an increase in HF power ( p = 0.001, d = -0.97), compared to the CON group. No significant changes were found for time-domain variables, although increases with a moderate effect size were seen for SDNN ( p = 0.152, d = -0.41) and RMSSD ( p = 0.059, d = -0.49) compared to the CON group. Conclusion: A short-term resistance exercise-training program was able to modulate HRV in children and adolescents with CF presenting mild to moderate lung function impairment and good physical condition. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT04293926.",2021,"Exercise induced significant changes in the frequency-domain variables, including a decrease in LF power ( p = 0.001, d = 0.98) and LF/HF ratio ( p = 0.020, d = 0.92), and an increase in HF power (","['children and adolescents with CF', 'Children With Cystic Fibrosis', 'children and adolescents with CF presenting mild to moderate lung function impairment and good physical condition', 'Mean age was 12.2 ± 3.3, FEV 1 (forced expiratory volume in the first second) z-score was 1.72 ± 1.54 and peak oxygen consumption (VO 2 peak) 42.7 ± 7.4 mL.Kg -1', 'healthy children', 'children diagnosed with CF aged 6-18 years', 'Nineteen subjects (13 boys']","['Short-Term Resistance-Training Program', 'resistance exercise-training program', 'control (CON) and resistance-training (EX', 'short-term resistance exercise program', 'CON']","['HF power ', 'LF power', 'LF/HF ratio', 'frequency-domain variables', 'Upper and lower limbs exercises (seated bench press, seated lateral row, and leg press', 'time-domain variables', 'RMSSD', 'heart rate variability (HRV', 'Heart Rate Variability', 'moderate effect size', 'HRV']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517688', 'cui_str': '3.3'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C4517513', 'cui_str': '1.72'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0870221', 'cui_str': 'Male child'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0454361', 'cui_str': 'Lower limb exercises'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",,0.0392094,"Exercise induced significant changes in the frequency-domain variables, including a decrease in LF power ( p = 0.001, d = 0.98) and LF/HF ratio ( p = 0.020, d = 0.92), and an increase in HF power (","[{'ForeName': 'Agustín Jesús', 'Initials': 'AJ', 'LastName': 'Estévez-González', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Márcio Vinícius Fagundes', 'Initials': 'MVF', 'LastName': 'Donadio', 'Affiliation': 'Laboratory of Pediatric Physical Activity, Centro Infant, Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Porto Alegre, Brazil.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Cobo-Vicente', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Fernández-Luna', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Sanz-Santiago', 'Affiliation': 'Pulmonology Unit, Hospital Universitario Niño Jesús de Madrid, Madrid, Spain.'}, {'ForeName': 'José Ramón', 'Initials': 'JR', 'LastName': 'Villa Asensi', 'Affiliation': 'Pulmonology Unit, Hospital Universitario Niño Jesús de Madrid, Madrid, Spain.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Iturriaga Ramirez', 'Affiliation': 'Laboratory of Pediatric Physical Activity, Centro Infant, Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Porto Alegre, Brazil.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Fernández-Del-Valle', 'Affiliation': 'Department of Applied Health, Southern Illinois University (SIUE), Edwardsville, IL, United States.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Diez-Vega', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Eneko', 'Initials': 'E', 'LastName': 'Larumbe-Zabala', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Pérez-Ruiz', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain.'}]",Frontiers in physiology,['10.3389/fphys.2021.652029'] 3899,33859554,Modulating Inhibitory Control Processes Using Individualized High Definition Theta Transcranial Alternating Current Stimulation (HD θ-tACS) of the Anterior Cingulate and Medial Prefrontal Cortex.,"Increased frontal midline theta activity generated by the anterior cingulate cortex (ACC) is induced by conflict processing in the medial frontal cortex (MFC). There is evidence that theta band transcranial alternating current stimulation (θ-tACS) modulates ACC function and alters inhibitory control performance during neuromodulation. Multi-electric (256 electrodes) high definition θ-tACS (HD θ-tACS) using computational modeling based on individual MRI allows precise neuromodulation targeting of the ACC via the medial prefrontal cortex (mPFC), and optimizes the required current density with a minimum impact on the rest of the brain. We therefore tested whether the individualized electrode montage of HD θ-tACS with the current flow targeted to the mPFC-ACC compared with a fixed montage (non-individualized) induces a higher post-modulatory effect on inhibitory control. Twenty healthy subjects were randomly assigned to a sequence of three HD θ-tACS conditions (individualized mPFC-ACC targeting; non-individualized MFC targeting; and a sham) in a double-blind cross-over study. Changes in the Visual Simon Task, Stop Signal Task, CPT III, and Stroop test were assessed before and after each session. Compared with non-individualized θ-tACS, the individualized HD θ-tACS significantly increased the number of interference words and the interference score in the Stroop test. The changes in the non-verbal cognitive tests did not induce a parallel effect. This is the first study to examine the influence of individualized HD θ-tACS targeted to the ACC on inhibitory control performance. The proposed algorithm represents a well-tolerated method that helps to improve the specificity of neuromodulation targeting of the ACC.",2021,"Changes in the Visual Simon Task, Stop Signal Task, CPT III, and Stroop test were assessed before and after each session.",['Twenty healthy subjects'],"['theta band transcranial alternating current stimulation (θ-tACS', 'Individualized High Definition Theta Transcranial Alternating Current Stimulation (HD θ-tACS', 'HD θ-tACS conditions (individualized mPFC-ACC targeting; non-individualized MFC targeting; and a sham', 'Multi-electric (256 electrodes', 'high definition θ-tACS (HD θ-tACS']","['Increased frontal midline theta activity', 'Visual Simon Task, Stop Signal Task, CPT III, and Stroop test', 'number of interference words and the interference score']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0220989', 'cui_str': 'Acquired partial lipodystrophy'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",20.0,0.0309385,"Changes in the Visual Simon Task, Stop Signal Task, CPT III, and Stroop test were assessed before and after each session.","[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Klírová', 'Affiliation': 'National Institute of Mental Health, Prague, Czechia.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Voráčková', 'Affiliation': 'National Institute of Mental Health, Prague, Czechia.'}, {'ForeName': 'Jiří', 'Initials': 'J', 'LastName': 'Horáček', 'Affiliation': 'National Institute of Mental Health, Prague, Czechia.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Mohr', 'Affiliation': 'National Institute of Mental Health, Prague, Czechia.'}, {'ForeName': 'Juraj', 'Initials': 'J', 'LastName': 'Jonáš', 'Affiliation': 'National Institute of Mental Health, Prague, Czechia.'}, {'ForeName': 'Daniela Urbaczka', 'Initials': 'DU', 'LastName': 'Dudysová', 'Affiliation': 'National Institute of Mental Health, Prague, Czechia.'}, {'ForeName': 'Lenka', 'Initials': 'L', 'LastName': 'Kostýlková', 'Affiliation': 'National Institute of Mental Health, Prague, Czechia.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Fayette', 'Affiliation': 'National Institute of Mental Health, Prague, Czechia.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Krejčová', 'Affiliation': 'National Institute of Mental Health, Prague, Czechia.'}, {'ForeName': 'Silvie', 'Initials': 'S', 'LastName': 'Baumann', 'Affiliation': 'National Institute of Mental Health, Prague, Czechia.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Laskov', 'Affiliation': 'National Institute of Mental Health, Prague, Czechia.'}, {'ForeName': 'Tomáš', 'Initials': 'T', 'LastName': 'Novák', 'Affiliation': 'National Institute of Mental Health, Prague, Czechia.'}]",Frontiers in systems neuroscience,['10.3389/fnsys.2021.611507'] 3900,33859520,Oral Resveratrol supplementation attenuates exercise-induced Interleukin-6 but not Oxidative Stress after a high intensity cycling challenge in adults.,"Previous studies demonstrated that resveratrol (RES) is able to enhance antioxidant, anti-inflammatory and insulin actions in humans. It is unclear whether RES can be used as ergogenic aids to enhance high-intensity cycling exercise performance and attenuate the high-intensity exercise-induced oxidative stress and inflammation. This study investigated the effect of RES supplementation on oxidative stress, inflammation, exercise-induced fatigue, and endurance performance. Eight male athletes participated in this single-blind crossover designed study and randomly instructed to receive four days of either oral RES (480 mg per day, totally 1920mg) or placebo supplementation. The cycling exercise challenge at 80% maximal oxygen consumption with 60 rpm was performed following 4 days of either RES or placebo supplementation. The total cycling performance time was recorded. In addition, blood samples were obtained to analyze the changes in blood glucose, plasma non-esterified fatty acid, serum lactate dehydrogenase, creatine kinase, uric acid, total antioxidant capacity, malondialdehyde, tumor necrosis factor-α, and interleukin-6. The exhausting time of cycling exercise challenge was not significantly increased in RES compared to that in placebo. However, IL-6 response was significantly decreased during exercise challenge in RES trial, and there were no differences in blood biomarkers, fatigue factors, and antioxidative response. Oral RES supplementation can attenuate exercise-induced IL-6 response but not fatigue and oxidative stress, inflammation response. However, we infer that 4-day oral RES supplementation has no ergogenic property on enhancing the high-intensity cycling exercise performance.",2021,"Oral RES supplementation can attenuate exercise-induced IL-6 response but not fatigue and oxidative stress, inflammation response.","['Eight male athletes', 'adults']","['placebo supplementation', 'Oral RES supplementation', 'placebo', 'Oral Resveratrol supplementation', 'RES supplementation', 'oral RES', 'RES or placebo supplementation', 'resveratrol (RES']","['RES', 'blood biomarkers, fatigue factors, and antioxidative response', 'exhausting time of cycling exercise challenge', 'oxidative stress, inflammation, exercise-induced fatigue, and endurance performance', 'high-intensity cycling exercise performance', 'total cycling performance time', 'IL-6 response', 'blood glucose, plasma non-esterified fatty acid, serum lactate dehydrogenase, creatine kinase, uric acid, total antioxidant capacity, malondialdehyde, tumor necrosis factor-α, and interleukin-6']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0073096', 'cui_str': 'resveratrol'}]","[{'cui': 'C0073096', 'cui_str': 'resveratrol'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231226', 'cui_str': 'Exhausting'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1293901', 'cui_str': 'Exercise challenge'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C2732413', 'cui_str': 'Postexertional fatigue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0369212', 'cui_str': 'Esterified fatty acid'}, {'cui': 'C1278052', 'cui_str': 'Serum lactate dehydrogenase measurement'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}]",8.0,0.0433325,"Oral RES supplementation can attenuate exercise-induced IL-6 response but not fatigue and oxidative stress, inflammation response.","[{'ForeName': 'Jung-Piao', 'Initials': 'JP', 'LastName': 'Tsao', 'Affiliation': 'Department of Physical Education, National Taichung University of Education, Taichung City, Taiwan.'}, {'ForeName': 'Chia-Chen', 'Initials': 'CC', 'LastName': 'Liu', 'Affiliation': 'Department of Physical Education, National Taichung University of Education, Taichung City, Taiwan.'}, {'ForeName': 'Hsueh-Fang', 'Initials': 'HF', 'LastName': 'Wang', 'Affiliation': 'Department of Nutrition, Institute of Biomedical Nutrition, Hungkuang University, Taichung City, Taiwan.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Bernard', 'Affiliation': 'Department of Kinesiology, California State University, Stanislaus, Turlock, CA, USA.'}, {'ForeName': 'Chun-Ching', 'Initials': 'CC', 'LastName': 'Huang', 'Affiliation': 'Department of Exercise and Health Science, National Taipei University of Nursing and Health Science, Taipei City, Taiwan.'}, {'ForeName': 'I-Shiung', 'Initials': 'IS', 'LastName': 'Cheng', 'Affiliation': 'Department of Physical Education, National Taichung University of Education, Taichung City, Taiwan.'}]",International journal of medical sciences,['10.7150/ijms.55633'] 3901,33859511,Effects of Vision Health Education and Free Eyeglasses on Knowledge of Vision and Usage of Spectacles Among Primary School Students: Evidence from Gansu and Shaanxi Provinces in China.,"Background In rural China, children's vision problems are very common, with many who would benefit from refractive correction not getting the care they need. This study examines whether a health information campaign that involves vision health education and a free trial of health product with free eyeglasses is effective at raising students' awareness of myopia and promoting students' eyeglasses usage. Methods We conducted an in-the-field randomized controlled experiment of a program providing vision health education and subsidized free eyeglasses to myopic children from 168 primary schools in rural Northwestern China in 2012. Results A total of 2189 students, mean age 10.5 years (49.3% male), participated in the baseline survey. At the baseline, the average correct response rate for visual knowledge among the sample students was 30.1%, and only 15% who needed eyeglasses used them. Seven months after intervention, the average correct response rate for vision knowledge were 48.5% and 48.3% in the education group and the education plus free eyeglasses group respectively, significantly higher than that of the control group. The rate of eyeglasses usage was 36% and 43% in the free eyeglasses group and the education plus free eyeglasses group respectively, significantly higher than that of the control group. The rate of eyeglasses compliance in the free eyeglasses group and the education plus free eyeglasses group was 19% and 26%, which also were significantly higher than the control group. Conclusion The information campaign combined with subsidized eyeglasses had a better effect both on vision knowledge and eyeglasses usage. The information campaign improved knowledge by providing the right information, and free eyeglasses changed the perceived utility and experience by the students using the product and getting benefits. Information and the free eyeglasses (subsidized) are complements.",2021,The information campaign combined with subsidized eyeglasses had a better effect both on vision knowledge and eyeglasses usage.,"['Primary School Students: Evidence from Gansu and Shaanxi Provinces in China', 'to myopic children from 168 primary schools in rural Northwestern China in 2012', 'A total of 2189 students, mean age 10.5 years (49.3% male), participated in the baseline survey']","['health information campaign', 'program providing vision health education and subsidized free eyeglasses', 'Vision Health Education and Free Eyeglasses']","['Knowledge of Vision and Usage of Spectacles', 'vision knowledge and eyeglasses usage', 'average correct response rate for vision knowledge', 'rate of eyeglasses compliance', 'rate of eyeglasses usage', 'average correct response rate for visual knowledge']","[{'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]",2189.0,0.0881433,The information campaign combined with subsidized eyeglasses had a better effect both on vision knowledge and eyeglasses usage.,"[{'ForeName': 'Yunyun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Center for Experimental Economics in Education, Shaanxi Normal University, Xi'an, People's Republic of China.""}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Guan', 'Affiliation': ""Center for Experimental Economics in Education, Shaanxi Normal University, Xi'an, People's Republic of China.""}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Du', 'Affiliation': ""Center for Experimental Economics in Education, Shaanxi Normal University, Xi'an, People's Republic of China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ""Center for Experimental Economics in Education, Shaanxi Normal University, Xi'an, People's Republic of China.""}, {'ForeName': 'Yaojiang', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': ""Center for Experimental Economics in Education, Shaanxi Normal University, Xi'an, People's Republic of China.""}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Center for Experimental Economics in Education, Shaanxi Normal University, Xi'an, People's Republic of China.""}, {'ForeName': 'Decai', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': ""Zhongshan Ophthalmic Center, State Key Laboratory of Ophthalmology, Sun Yat-Sen University, Guangzhou, People's Republic of China.""}]",Risk management and healthcare policy,['10.2147/RMHP.S297265'] 3902,33859330,Anxiolytic effects of a galacto-oligosaccharides prebiotic in healthy females (18-25 years) with corresponding changes in gut bacterial composition.,"Current research implicates pre- and probiotic supplementation as a potential tool for improving symptomology in physical and mental ailments, which makes it an attractive concept for clinicians and consumers alike. Here we focus on the transitional period of late adolescence and early adulthood during which effective interventions, such as nutritional supplementation to influence the gut microbiota, have the potential to offset health-related costs in later life. We examined multiple indices of mood and well-being in 64 healthy females in a 4-week double blind, placebo controlled galacto-oligosaccharides (GOS) prebiotic supplement intervention and obtained stool samples at baseline and follow-up for gut microbiota sequencing and analyses. We report effects of the GOS intervention on self-reported high trait anxiety, attentional bias, and bacterial abundance, suggesting that dietary supplementation with a GOS prebiotic may improve indices of pre-clinical anxiety. Gut microbiota research has captured the imagination of the scientific and lay community alike, yet we are now at a stage where this early enthusiasm will need to be met with rigorous research in humans. Our work makes an important contribution to this effort by combining a psychobiotic intervention in a human sample with comprehensive behavioural and gut microbiota measures.",2021,"Current research implicates pre- and probiotic supplementation as a potential tool for improving symptomology in physical and mental ailments, which makes it an attractive concept for clinicians and consumers alike.","['healthy females (18-25\xa0years) with corresponding changes in gut bacterial composition', '64 healthy females']","['probiotic supplementation', 'GOS intervention', 'placebo controlled galacto-oligosaccharides (GOS) prebiotic supplement intervention', 'galacto-oligosaccharides prebiotic']",['Anxiolytic effects'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C3179404', 'cui_str': 'Anti-Anxiety Effects'}]",64.0,0.0574508,"Current research implicates pre- and probiotic supplementation as a potential tool for improving symptomology in physical and mental ailments, which makes it an attractive concept for clinicians and consumers alike.","[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Johnstone', 'Affiliation': 'School of Psychology, Faculty of Health and Medical Sciences, University of Surrey, Guildford, GU2 7XH, UK. nicola.johnstone@surrey.ac.uk.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Milesi', 'Affiliation': 'School of Psychology, Faculty of Health and Medical Sciences, University of Surrey, Guildford, GU2 7XH, UK.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Burn', 'Affiliation': 'School of Psychology, Faculty of Health and Medical Sciences, University of Surrey, Guildford, GU2 7XH, UK.'}, {'ForeName': 'Bartholomeus', 'Initials': 'B', 'LastName': 'van den Bogert', 'Affiliation': 'BaseClear, Leiden, The Netherlands.'}, {'ForeName': 'Arjen', 'Initials': 'A', 'LastName': 'Nauta', 'Affiliation': 'FrieslandCampina, Amersfoort, The Netherlands.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Hart', 'Affiliation': 'Department of Nutritional Sciences, School of Biosciences and Medicine, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sowden', 'Affiliation': 'School of Psychology, Faculty of Health and Medical Sciences, University of Surrey, Guildford, GU2 7XH, UK.'}, {'ForeName': 'Philip W J', 'Initials': 'PWJ', 'LastName': 'Burnet', 'Affiliation': 'Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Cohen Kadosh', 'Affiliation': 'School of Psychology, Faculty of Health and Medical Sciences, University of Surrey, Guildford, GU2 7XH, UK. k.cohenkadosh@surrey.ac.uk.'}]",Scientific reports,['10.1038/s41598-021-87865-w'] 3903,33859297,Effects of transcranial static magnetic stimulation over the primary motor cortex on local and network spontaneous electroencephalogram oscillations.,"Transcranial static magnetic stimulation (tSMS) is a novel non-invasive brain stimulation technique that reduces cortical excitability at the stimulation site. We investigated the effects of tSMS over the left primary motor cortex (M1) for 20 min on the local electroencephalogram (EEG) power spectrum and interregional EEG coupling. Twelve right-handed healthy subjects participated in this crossover, double-blind, sham-controlled study. Resting-state EEG data were recorded for 3 min before the intervention and 17 min after the beginning of the intervention. The power spectrum at the left central electrode (C3) and the weighted phase lag index (wPLI) between C3 and the other electrodes was calculated for theta (4-8 Hz), alpha (8-12 Hz), and beta (12-30 Hz) frequencies. The tSMS significantly increased theta power at C3 and the functional coupling in the theta band between C3 and the parietal midline electrodes. The tSMS over the left M1 for 20 min exhibited modulatory effects on local cortical activity and interregional functional coupling in the theta band. The neural oscillations in the theta band may have an important role in the neurophysiological effects induced by tSMS over the frontal cortex.",2021,The tSMS significantly increased theta power at C3 and the functional coupling in the theta band between C3 and the parietal midline electrodes.,['Twelve right-handed healthy subjects'],"['tSMS', 'transcranial static magnetic stimulation', 'Transcranial static magnetic stimulation (tSMS']","['local cortical activity and interregional functional coupling', 'cortical excitability', 'local and network spontaneous electroencephalogram oscillations']","[{'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]",,0.024586,The tSMS significantly increased theta power at C3 and the functional coupling in the theta band between C3 and the parietal midline electrodes.,"[{'ForeName': 'Sumiya', 'Initials': 'S', 'LastName': 'Shibata', 'Affiliation': 'Kinugasa Research Organization, Ritsumeikan University, 56-1, Tojiin, Kitamachi, Kita-ku, Kyoto, Kyoto, 603-8577, Japan. sshiba@kuhp.kyoto-u.ac.jp.'}, {'ForeName': 'Tatsunori', 'Initials': 'T', 'LastName': 'Watanabe', 'Affiliation': 'Department of Sensorimotor Neuroscience, Graduate School of Biomedical and Health Sciences, Hiroshima University, 1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima, 734-8553, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Yukawa', 'Affiliation': 'Department of Rehabilitation, Murata Hospital, 4-2-1, Tajima, Ikuno-ku, Osaka, Osaka, 544-0011, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Minakuchi', 'Affiliation': 'Department of Rehabilitation, Murata Hospital, 4-2-1, Tajima, Ikuno-ku, Osaka, Osaka, 544-0011, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Shimomura', 'Affiliation': 'Department of Rehabilitation, Murata Hospital, 4-2-1, Tajima, Ikuno-ku, Osaka, Osaka, 544-0011, Japan.'}, {'ForeName': 'Sachimori', 'Initials': 'S', 'LastName': 'Ichimura', 'Affiliation': 'Department of Rehabilitation, Murata Hospital, 4-2-1, Tajima, Ikuno-ku, Osaka, Osaka, 544-0011, Japan.'}, {'ForeName': 'Hikari', 'Initials': 'H', 'LastName': 'Kirimoto', 'Affiliation': 'Department of Sensorimotor Neuroscience, Graduate School of Biomedical and Health Sciences, Hiroshima University, 1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima, 734-8553, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Mima', 'Affiliation': 'The Graduate School of Core Ethics and Frontier Sciences, Ritsumeikan University, 56-1, Tojiin, Kitamachi, Kita-ku, Kyoto, Kyoto, 603-8577, Japan. t-mima@fc.ritsumei.ac.jp.'}]",Scientific reports,['10.1038/s41598-021-87746-2'] 3904,33859214,Food-related impulsivity assessed by longitudinal laboratory tasks is reduced in patients with binge eating disorder in a randomized controlled trial.,"Food-related impulsivity, i.e. a food-related attentional bias proposed to be due to increased reward sensitivity and diminished inhibitory control, has been cross-sectionally associated with binge eating disorder. To analyze changes in food-related impulsivity, we implemented longitudinal analyses of objective laboratory tasks in a randomized controlled trial called IMPULS. Patients who attended an impulsivity-focused group intervention (IG N = 31) and control patients who did not take part in the intervention (CG N = 25) were compared before (T0) and after the intervention period (T1) and at three months follow-up (T2). Patients' impulsive gaze behavior towards food vs. neutral stimuli was measured in two eye tracking paradigms, one addressing reward sensitivity and another addressing inhibitory control. Initial fixations of food vs. neutral stimuli were increased at T0 (IG: p = .014, CG: p = .001), but not at T1 and T2 in IG (T1: p = .178, T2: p = .203) and in CG after Bonferroni correction only at T2 (T1: p = .031, T2: p = .002). Patients from IG increased dwell time on neutral stimuli at T1 contrary to patients from CG (p = .016) and rated the presented food stimuli as less positive (e.g. pleasantness p < .001 at T1 and T2). A possible explanation for this observation is reduced reward sensitivity, which implies a short-term treatment effect. Both groups showed improvement in inhibiting eye movements towards food and neutral stimuli over time (i.e. first saccade errors overall p < .001, second saccade errors overall p < .003). This could indicate increased inhibitory control due to training effects from the study paradigm. The results suggest that food-related impulsivity represents an underlying mechanism of BED and that it is modifiable by cognitive behavioral interventions.",2021,Patients from IG increased dwell time on neutral stimuli at T1 contrary to patients from CG (p = .016) and rated the presented food stimuli as less positive (e.g. pleasantness p < .001 at T1 and T2).,"['patients with binge eating disorder', 'Patients who attended an impulsivity-focused group']",['intervention (IG N\u2009=\u200931) and control patients who did not take part in the intervention'],"['inhibiting eye movements towards food and neutral stimuli over time', 'impulsive gaze behavior towards food vs. neutral stimuli', 'Initial fixations of food vs. neutral stimuli', 'dwell time on neutral stimuli']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0429659', 'cui_str': 'Dwell time'}]",31.0,0.0277145,Patients from IG increased dwell time on neutral stimuli at T1 contrary to patients from CG (p = .016) and rated the presented food stimuli as less positive (e.g. pleasantness p < .001 at T1 and T2).,"[{'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Schag', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Medical University Hospital Tübingen, Osianderstraße 5, 72076, Tübingen, Germany. kathrin.schag@med.uni-tuebingen.de.'}, {'ForeName': 'Elisabeth J', 'Initials': 'EJ', 'LastName': 'Leehr', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Münster, Münster, Germany.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Meneguzzo', 'Affiliation': 'Department of Neurosciences, University of Padova, Padova, Italy.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Martus', 'Affiliation': 'Institute for Clinical Epidemiology and Applied Biostatistics, Medical University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Zipfel', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Medical University Hospital Tübingen, Osianderstraße 5, 72076, Tübingen, Germany.'}, {'ForeName': 'Katrin E', 'Initials': 'KE', 'LastName': 'Giel', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Medical University Hospital Tübingen, Osianderstraße 5, 72076, Tübingen, Germany.'}]",Scientific reports,['10.1038/s41598-021-87231-w'] 3905,33859173,Comparison of the acute metabolic effect of different infant formulas and human milk in healthy adults: a randomized trial.,"BACKGROUND/OBJECTIVES Different infant formulas, varying in protein type and quantity, are available for infants who are not breastfed or are partially breastfed. Postprandial insulinemic and glycemic responses to intact vs partially hydrolyzed protein in infant formula are unclear. To compare the effect of different forms (partially hydrolyzed vs non-hydrolyzed) and levels of protein in infant formula compared with a human milk reference subgroup on insulin response in adults. SUBJECTS/METHODS In a randomized, double-blinded, cross-over study, 35 healthy adults consumed 600 ml of three different infant formulas: Intact protein-based formula (INTACT) (1.87 g protein/100 kcal; whey/casein ratio of 70/30; 63 kcal/100 ml), partially hydrolyzed whey-based formula (PHw) (1.96 g protein/100 kcal; 100% whey; 63 kcal/100 ml), a high-protein partially hydrolyzed whey-based formula (HPPHw) (2.79 g protein/100 kcal; 100%whey; 73 kcal/100 ml) and a subgroup also consumed human milk (HM) (n = 11). Lipid and carbohydrate (lactose) contents were similar (5.1-5.5 and 10.5-11.6 g/100 kcal, respectively). Venous blood samples were taken after overnight fasting and at different intervals for 180 min post-drink for insulin, glucose, blood lipids, GLP-1, glucagon, and C-peptide. RESULTS Twenty-nine subjects (eight consuming HM) adhered to the protocol. INTACT and PHw groups had similar postprandial insulinemia and glycaemia (C max and iAUC) that were not different from those of the HM subgroup. HPPHw resulted in higher postprandial insulin responses (iAUC) relative to all other groups (p < 0.001, p < 0.001, p = 0.002 for the comparison with INTACT, PHw, HM, respectively). HPPHw resulted in a higher glucose response compared to INTACT and PHw (iAUC: p = 0.003, p = 0.001, respectively), but was not different from HM (p = 0.41). CONCLUSION This study in adults demonstrates similar postprandial insulinemia and glycaemia between INTACT and PHw, close to that of HM, but lower than HPPHw, which had a higher protein content compared to the other test milks. The findings remain to be confirmed in infants. CLINICAL TRIAL REGISTRATION This study is registered at clinicaltrials.gov, identifier NCT04332510.",2021,"HPPHw resulted in higher postprandial insulin responses (iAUC) relative to all other groups (p < 0.001, p < 0.001, p = 0.002 for the comparison with INTACT, PHw, HM, respectively).","['infants who are not breastfed or are partially breastfed', 'healthy adults', 'infant formula compared with a human milk reference subgroup on insulin response in adults', '35 healthy adults consumed 600\u2009ml of three different infant formulas']","['Intact protein-based formula (INTACT) ', 'HPPHw', 'partially hydrolyzed whey-based formula (PHw', 'infant formulas and human milk', 'high-protein partially hydrolyzed whey-based formula (HPPHw', 'subgroup also consumed human milk (HM']","['postprandial insulin responses (iAUC', 'Postprandial insulinemic and glycemic responses', 'Lipid and carbohydrate (lactose) contents', 'postprandial insulinemia and glycaemia', 'Venous blood samples', 'postprandial insulinemia and glycaemia (C max and iAUC', 'glucose response']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0150589', 'cui_str': 'Infant formula'}, {'cui': 'C0026140', 'cui_str': 'Breast milk'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3816748', 'cui_str': '600'}]","[{'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0150589', 'cui_str': 'Infant formula'}, {'cui': 'C0026140', 'cui_str': 'Breast milk'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",35.0,0.118565,"HPPHw resulted in higher postprandial insulin responses (iAUC) relative to all other groups (p < 0.001, p < 0.001, p = 0.002 for the comparison with INTACT, PHw, HM, respectively).","[{'ForeName': 'Yasaman', 'Initials': 'Y', 'LastName': 'Shahkhalili', 'Affiliation': 'Société des Produits Nestlé S.A, Lausanne, Switzerland.'}, {'ForeName': 'Cathriona', 'Initials': 'C', 'LastName': 'Monnard', 'Affiliation': 'Société des Produits Nestlé S.A, Lausanne, Switzerland. cathriona.monnard@rd.nestle.com.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Grathwohl', 'Affiliation': 'Société des Produits Nestlé S.A, Lausanne, Switzerland.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Sauser', 'Affiliation': 'Société des Produits Nestlé S.A, Lausanne, Switzerland.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Beaumont', 'Affiliation': 'Société des Produits Nestlé S.A, Lausanne, Switzerland.'}, {'ForeName': 'Corinne Ammon', 'Initials': 'CA', 'LastName': 'Zufferey', 'Affiliation': 'Société des Produits Nestlé S.A, Lausanne, Switzerland.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Macé', 'Affiliation': 'Société des Produits Nestlé S.A, Lausanne, Switzerland.'}]",Nutrition & diabetes,['10.1038/s41387-021-00154-3'] 3906,33859168,Clinical effect and antiviral mechanism of T-705 in treating severe fever with thrombocytopenia syndrome.,"Severe fever with thrombocytopenia syndrome (SFTS) virus (SFTSV) is an emerging tick-borne virus with high fatality and an expanding endemic. Currently, effective anti-SFTSV intervention remains unavailable. Favipiravir (T-705) was recently reported to show in vitro and in animal model antiviral efficacy against SFTSV. Here, we conducted a single-blind, randomized controlled trial to assess the efficacy and safety of T-705 in treating SFTS (Chinese Clinical Trial Registry website, number ChiCTR1900023350). From May to August 2018, laboratory-confirmed SFTS patients were recruited from a designated hospital and randomly assigned to receive oral T-705 in combination with supportive care or supportive care only. Fatal outcome occurred in 9.5% (7/74) of T-705 treated patients and 18.3% (13/71) of controls (odds ratio, 0.466, 95% CI, 0.174-1.247). Cox regression showed a significant reduction in case fatality rate (CFR) with an adjusted hazard ratio of 0.366 (95% CI, 0.142-0.944). Among the low-viral load subgroup (RT-PCR cycle threshold ≥26), T-705 treatment significantly reduced CFR from 11.5 to 1.6% (P = 0.029), while no between-arm difference was observed in the high-viral load subgroup (RT-PCR cycle threshold <26). The T-705-treated group showed shorter viral clearance, lower incidence of hemorrhagic signs, and faster recovery of laboratory abnormities compared with the controls. The in vitro and animal experiments demonstrated that the antiviral efficacies of T-705 were proportionally induced by SFTSV mutation rates, particularly from two transition mutation types. The mutation analyses on T-705-treated serum samples disclosed a partially consistent mutagenesis pattern as those of the in vitro or animal experiments in reducing the SFTSV viral loads, further supporting the anti-SFTSV effect of T-705, especially for the low-viral loads.",2021,"The T-705-treated group showed shorter viral clearance, lower incidence of hemorrhagic signs, and faster recovery of laboratory abnormities compared with the controls.","['severe fever with thrombocytopenia syndrome', 'Severe fever with thrombocytopenia syndrome (SFTS) virus (SFTSV', 'From May to August 2018, laboratory-confirmed SFTS patients were recruited from a designated hospital']",['oral T-705 in combination with supportive care or supportive care only'],"['shorter viral clearance', 'CFR', 'case fatality rate (CFR', 'efficacy and safety', 'Fatal outcome', 'hemorrhagic signs, and faster recovery of laboratory abnormities']","[{'cui': 'C4284413', 'cui_str': 'Severe fever with thrombocytopenia syndrome virus'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1138226', 'cui_str': 'favipiravir'}, {'cui': 'C0344211', 'cui_str': 'Support'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0282250', 'cui_str': 'Case fatality rate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0206277', 'cui_str': 'Fatal Outcome'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]",,0.145383,"The T-705-treated group showed shorter viral clearance, lower incidence of hemorrhagic signs, and faster recovery of laboratory abnormities compared with the controls.","[{'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Beijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, Beijing, P. R. China.'}, {'ForeName': 'Xia-Ming', 'Initials': 'XM', 'LastName': 'Jiang', 'Affiliation': 'State Key Laboratory of Virology, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, Hubei, P. R. China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Cui', 'Affiliation': ""The 154 Hospital, People's Liberation Army, Xinyang, Henan, P. R. China.""}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Yuan', 'Affiliation': ""The 154 Hospital, People's Liberation Army, Xinyang, Henan, P. R. China.""}, {'ForeName': 'Shao-Fei', 'Initials': 'SF', 'LastName': 'Zhang', 'Affiliation': 'Beijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, Beijing, P. R. China.'}, {'ForeName': 'Qing-Bin', 'Initials': 'QB', 'LastName': 'Lu', 'Affiliation': 'School of Public Health, Peking University, Beijing, P. R. China.'}, {'ForeName': 'Zhen-Dong', 'Initials': 'ZD', 'LastName': 'Yang', 'Affiliation': ""The 154 Hospital, People's Liberation Army, Xinyang, Henan, P. R. China.""}, {'ForeName': 'Qin-Lin', 'Initials': 'QL', 'LastName': 'Xin', 'Affiliation': 'State Key Laboratory of Virology, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, Hubei, P. R. China.'}, {'ForeName': 'Ya-Bin', 'Initials': 'YB', 'LastName': 'Song', 'Affiliation': 'Beijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, Beijing, P. R. China.'}, {'ForeName': 'Xiao-Ai', 'Initials': 'XA', 'LastName': 'Zhang', 'Affiliation': 'Beijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, Beijing, P. R. China.'}, {'ForeName': 'Hai-Zhou', 'Initials': 'HZ', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Virology, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, Hubei, P. R. China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'School of Public Health, Peking University, Beijing, P. R. China.'}, {'ForeName': 'Xue-Juan', 'Initials': 'XJ', 'LastName': 'Fan', 'Affiliation': ""The 154 Hospital, People's Liberation Army, Xinyang, Henan, P. R. China.""}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Yuan', 'Affiliation': ""The 154 Hospital, People's Liberation Army, Xinyang, Henan, P. R. China.""}, {'ForeName': 'Yi-Mei', 'Initials': 'YM', 'LastName': 'Yuan', 'Affiliation': ""The 154 Hospital, People's Liberation Army, Xinyang, Henan, P. R. China.""}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""The 154 Hospital, People's Liberation Army, Xinyang, Henan, P. R. China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""The 154 Hospital, People's Liberation Army, Xinyang, Henan, P. R. China.""}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""The 154 Hospital, People's Liberation Army, Xinyang, Henan, P. R. China.""}, {'ForeName': 'Dong-Na', 'Initials': 'DN', 'LastName': 'Zhang', 'Affiliation': 'Beijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, Beijing, P. R. China.'}, {'ForeName': 'Zhi-Bo', 'Initials': 'ZB', 'LastName': 'Wang', 'Affiliation': 'Beijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, Beijing, P. R. China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Dai', 'Affiliation': 'Beijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, Beijing, P. R. China.'}, {'ForeName': 'Jie-Ying', 'Initials': 'JY', 'LastName': 'Bai', 'Affiliation': 'Institute of Molecular Medicine, Peking University, Beijing, P. R. China.'}, {'ForeName': 'Zhao-Nian', 'Initials': 'ZN', 'LastName': 'Hao', 'Affiliation': 'Tongji Medical College, Huazhong University of Science and Technology, Wuhan, P. R. China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Fan', 'Affiliation': 'Beijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, Beijing, P. R. China.'}, {'ForeName': 'Li-Qun', 'Initials': 'LQ', 'LastName': 'Fang', 'Affiliation': 'Beijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, Beijing, P. R. China.'}, {'ForeName': 'Gengfu', 'Initials': 'G', 'LastName': 'Xiao', 'Affiliation': 'State Key Laboratory of Virology, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, Hubei, P. R. China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Biostatistics and Emerging Pathogens Institute, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Peng', 'Affiliation': 'State Key Laboratory of Virology, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, Hubei, P. R. China.'}, {'ForeName': 'Hong-Quan', 'Initials': 'HQ', 'LastName': 'Wang', 'Affiliation': 'Beijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, Beijing, P. R. China.'}, {'ForeName': 'Jian-Xiong', 'Initials': 'JX', 'LastName': 'Li', 'Affiliation': ""Department of Cancer, People's Liberation Army General Hospital, Beijing, P. R. China. 301301ljx@sina.com.""}, {'ForeName': 'Lei-Ke', 'Initials': 'LK', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Virology, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, Hubei, P. R. China. zhangleike@wh.iov.cn.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Beijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, Beijing, P. R. China. liuwei@bmi.ac.cn.'}]",Signal transduction and targeted therapy,['10.1038/s41392-021-00541-3'] 3907,33859155,Efficacy and Safety of Once-Daily LCP-Tacrolimus Versus Twice-Daily Immediate-Release Tacrolimus in Adult Hispanic Stable Kidney Transplant Recipients: Sub-Group Analysis from a Phase 3 Trial.,"BACKGROUND The pharmacokinetics and metabolism of tacrolimus, an immunosuppressant commonly used to prevent transplant rejection, can differ in specific subpopulations. This analysis examined treatment outcomes and safety of immediate-release tacrolimus (IR-Tac) and LCP-tacrolimus (LCPT) in stable Hispanic kidney transplant recipients. MATERIAL AND METHODS This was a post hoc analysis of clinical trial data from Hispanic adult stable kidney transplant recipients randomized to remain on IR-Tac or convert from IR-Tac to a reduced dose of LCPT (NCT00817206). Composite treatment failure was evaluated at 12 months. Estimated glomerular filtration rate and tacrolimus trough concentrations were evaluated over 12 months. RESULTS Fifty-five stable (LCPT n=26, IR-Tac n=29) kidney transplant recipients who self-identified as Hispanic or Latino were included in this analysis. Composite treatment failure occurred in 1 patient (4%) who converted to LCPT and 1 (3%) who remained on IR-Tac. The estimated glomerular filtration rate was stable over time and similar in the 2 treatment groups (P=0.08). Tacrolimus trough levels for both groups were similar over time in the 2 treatment groups (P=0.98). Treatment-emergent adverse events were similar in patients who converted to LCPT and in those who remained on IR-Tac. CONCLUSIONS Efficacy and safety were similar in Hispanic kidney transplant recipients who converted from IR-Tac to LCPT and in those remaining on IR-Tac.",2021,The estimated glomerular filtration rate was stable over time and similar in the 2 treatment groups (P=0.08).,"['stable Hispanic kidney transplant recipients', 'Hispanic adult stable kidney transplant recipients', 'Fifty-five stable (LCPT n=26, IR-Tac n=29) kidney transplant recipients who self-identified as Hispanic or Latino', 'Adult Hispanic Stable Kidney Transplant Recipients', 'Hispanic kidney transplant recipients']","['Once-Daily LCP-Tacrolimus Versus Twice-Daily Immediate-Release Tacrolimus', 'tacrolimus', 'immediate-release tacrolimus (IR-Tac) and LCP-tacrolimus (LCPT', 'LCPT']","['Efficacy and Safety', 'Estimated glomerular filtration rate and tacrolimus trough concentrations', 'glomerular filtration rate', 'Tacrolimus trough levels', 'Composite treatment failure', 'Efficacy and safety']","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0023234', 'cui_str': 'Coxa plana'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]","[{'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0023234', 'cui_str': 'Coxa plana'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}]",55.0,0.025481,The estimated glomerular filtration rate was stable over time and similar in the 2 treatment groups (P=0.08).,"[{'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Faravardeh', 'Affiliation': 'SHARP Kidney and Pancreas Transplant Center, San Diego, CA, USA.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Akkina', 'Affiliation': 'Loyola Outpatient Center, Loyola University Medical Center, Maywood, IL, USA.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Villicana', 'Affiliation': 'Loma Linda University Transplant Institute, Loma Linda University Health, Loma Linda, CA, USA.'}, {'ForeName': 'Giselle', 'Initials': 'G', 'LastName': 'Guerra', 'Affiliation': 'Miami Transplant Institute, University of Miami Health System, Miami, FL, USA.'}, {'ForeName': 'Misbah A', 'Initials': 'MA', 'LastName': 'Moten', 'Affiliation': 'Department of Medical Affairs, Veloxis Pharmaceuticals, Cary, NC, USA.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Meier-Kriesche', 'Affiliation': 'Department of Medical Affairs, Veloxis Pharmaceuticals, Cary, NC, USA.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Stevens', 'Affiliation': 'Department of Medical Affairs, Veloxis Pharmaceuticals, Cary, NC, USA.'}, {'ForeName': 'Samir J', 'Initials': 'SJ', 'LastName': 'Patel', 'Affiliation': 'Department of Medical Affairs, Veloxis Pharmaceuticals, Cary, NC, USA.'}, {'ForeName': 'Suphamai', 'Initials': 'S', 'LastName': 'Bunnapradist', 'Affiliation': 'Department of Medicine, Ronald Reagan UCLA Medical Center, Los Angeles, CA, USA.'}]",Annals of transplantation,['10.12659/AOT.929535'] 3908,33859140,Pharmacokinetics of Single Dose Lidocaine and Epinephrine Following Iontophoresis of the Tympanic Membrane in a Double-Blinded Randomized Trial.,"OBJECTIVE To evaluate local and systemic safety of bilateral iontophoretic administration of lidocaine with epinephrine or lidocaine alone to the tympanic membrane (TM). STUDY DESIGN A randomized, double-blind, two-arm study was conducted at a single center. Healthy adults were randomized to bilateral iontophoretic treatment with 2% lidocaine, 1:100,000 epinephrine, or 2% lidocaine (control). Otoscopy, cranial nerve examination, tympanometry, and audiometry safety evaluations were conducted before and 3-days post-procedure. Systemic safety was evaluated via analysis of vital signs taken before and up to 120 minutes post-iontophoresis, and blood samples collected before and up to 230 minutes post-iontophoresis. RESULTS Twenty-five subjects were treated with bilateral iontophoresis of either lidocaine and epinephrine (n = 15 subjects) or lidocaine alone (n = 10). Mean plasma epinephrine concentrations for both groups remained within the normal range for endogenous epinephrine. Mean plasma concentrations of lidocaine were not statistically different between groups, ranging from 0.245 to 2.28 ng/ml after administration of lidocaine with epinephrine (immediate post-iontophoresis to 230 min post-iontophoresis), compared with 1.35 to 2.14 ng/ml after administration of lidocaine alone. The presence of epinephrine slowed the systemic absorption of lidocaine. Lidocaine levels (Cmax 2.24 ng/ml) were approximately 2000-fold lower than the threshold for minor lidocaine toxicity. No device-, procedure- or drug-related adverse events were reported. CONCLUSION The local and systemic safety of bilateral iontophoretic delivery of 2% lidocaine, 1:100,000 epinephrine to the TM was demonstrated by low plasma levels of drug and absence of both serious and non-serious device-, procedure-, or drug-related adverse events.",2021,"Mean plasma concentrations of lidocaine were not statistically different between groups, ranging from 0.245 to 2.28 ng/ml after administration of lidocaine with epinephrine (immediate post-iontophoresis to 230 min post-iontophoresis), compared with 1.35 to 2.14 ng/ml after administration of lidocaine alone.","['Twenty-five subjects were treated with bilateral iontophoresis of either', 'Healthy adults']","['lidocaine with epinephrine or lidocaine', 'lidocaine, 1:100,000 epinephrine', 'lidocaine', 'bilateral iontophoretic treatment with 2% lidocaine, 1:100,000 epinephrine, or 2% lidocaine (control', 'lidocaine and epinephrine', 'Lidocaine and Epinephrine', 'lidocaine alone', 'epinephrine']","['low plasma levels of drug and absence of both serious and non-serious device-, procedure-, or drug-related adverse events', 'device-, procedure- or drug-related adverse events', 'Lidocaine levels', 'Mean plasma concentrations of lidocaine', 'Systemic safety', 'Otoscopy, cranial nerve examination, tympanometry, and audiometry safety evaluations', 'Mean plasma epinephrine concentrations']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0022024', 'cui_str': 'Iontophoresis procedure'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0202404', 'cui_str': 'Lidocaine measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0847244', 'cui_str': 'Endoscopy of ear'}, {'cui': 'C0558819', 'cui_str': 'Examination of cranial nerve'}, {'cui': 'C0085853', 'cui_str': 'Tympanometry testing'}, {'cui': 'C0004286', 'cui_str': 'Audiometric test'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]",25.0,0.118624,"Mean plasma concentrations of lidocaine were not statistically different between groups, ranging from 0.245 to 2.28 ng/ml after administration of lidocaine with epinephrine (immediate post-iontophoresis to 230 min post-iontophoresis), compared with 1.35 to 2.14 ng/ml after administration of lidocaine alone.","[{'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'England', 'Affiliation': 'Tusker Medical, Inc., a subsidiary of Smith + Nephew, Menlo Park, California Ear Medical Group ENT Clinics of San Antonio, San Antonio, Texas.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Syms', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'York', 'Affiliation': ''}]","Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology",['10.1097/MAO.0000000000003128'] 3909,33859075,Counterpunching to improve the health of people with Parkinson's disease.,"BACKGROUND Boxing programs designed specifically for people with Parkinson's disease (PD) can be beneficial in improving the physical, mental, and functional health of persons with PD. PURPOSE This study examined the effect of a boxing program, Rock Steady Boxing (RSB), on the health of people with PD from both the boxers' and their caregivers' perspectives as well as evaluated balance, quality of life (QoL), and depressive symptoms after 12 weeks of RSB. METHODS A mixed methods, one-group experimental design with focus groups were embedded within an intervention study. Six boxers completed baseline and 12-week postassessments. RESULTS The majority of boxers maintained or improved scores for balance, QoL, and reduced depressive symptoms. Findings indicate physical and mental benefits of RSB among persons with PD and this was further validated by qualitative data from boxers and caregivers, along with quantitative data of boxers. Caregivers and boxers reported that boxers' ability to perform activities of daily living (ADLs) improved and is supported by quantitative improvements in the Parkinson's disease Questionnaire-39 ADL subscale. All boxers reported reduced stigma, and caregivers and boxers valued the opportunity to work out in an environment free of stigma, a finding not previously reported. CONCLUSIONS It is important for nurse practitioners to recognize exercise benefits for people with PD and recommend the program to patients and include caregivers in their overall assessment of health and wellness. IMPLICATIONS FOR PRACTICE Nurse practitioners and other health practitioners may consider recommending a boxing program, such as RSB, for their PD patients as a sole or supplemental exercise program.",2021,Caregivers and boxers reported that boxers' ability to perform activities of daily living (ADLs) improved and is supported by quantitative improvements in the Parkinson's disease Questionnaire-39 ADL subscale.,"[""people with Parkinson's disease"", ""people with Parkinson's disease (PD"", 'Nurse practitioners and other health practitioners', 'nurse practitioners', 'persons with PD']","['boxing program, Rock Steady Boxing (RSB']","['majority of boxers maintained or improved scores for balance, QoL, and reduced depressive symptoms', 'balance, quality of life (QoL), and depressive symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0028657', 'cui_str': 'Nurse practitioner'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0005899', 'cui_str': 'Repetitive rocking movements'}, {'cui': 'C0205361', 'cui_str': 'Steady'}]","[{'cui': 'C0324320', 'cui_str': 'Boxer dog'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.0590649,Caregivers and boxers reported that boxers' ability to perform activities of daily living (ADLs) improved and is supported by quantitative improvements in the Parkinson's disease Questionnaire-39 ADL subscale.,"[{'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Hermanns', 'Affiliation': 'School of Nursing, The University of Texas at Tyler, Tyler, Texas.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Mastel-Smith', 'Affiliation': ''}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Donnell', 'Affiliation': ''}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Quarles', 'Affiliation': ''}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Rodriguez', 'Affiliation': ''}, {'ForeName': 'Tianjing', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': ''}]",Journal of the American Association of Nurse Practitioners,['10.1097/JXX.0000000000000598'] 3910,33858985,Effects of a Knowledge-Translation Intervention on Early Dialysis Initiation: A Cluster Randomized Trial.,"BACKGROUND The Initiating Dialysis Early and Late (IDEAL) trial, published in 2009, found no clinically measurable benefit with respect to risk of mortality or early complications with early dialysis initiation versus deferred dialysis start. After these findings, guidelines recommended an intent-to-defer approach to dialysis initiation, with the goal of deferring it until clinical symptoms arise. METHODS To evaluate a four-component knowledge translation intervention aimed at promoting an intent-to-defer strategy for dialysis initiation, we conducted a cluster randomized trial in Canada between October 2014 and November 2015. We randomized 55 clinics, 27 to the intervention group and 28 to the control group. The educational intervention, using knowledge-translation tools, included telephone surveys from a knowledge-translation broker, a 1-year center-specific audit with feedback, delivery of a guidelines package, and an academic detailing visit. Participants included adults who had at least 3 months of predialysis care and who started dialysis in the first year after the intervention. The primary efficacy outcome was the proportion of patients who initiated dialysis early (at eGFR >10.5 ml/min per 1.73 m 2 ). The secondary outcome was the proportion of patients who initiated in the acute inpatient setting. RESULTS The analysis included 3424 patients initiating dialysis in the 1-year follow-up period. Of these, 509 of 1592 (32.0%) in the intervention arm and 605 of 1832 (33.0%) in the control arm started dialysis early. There was no difference in the proportion of individuals initiating dialysis early or in the proportion of individuals initiating dialysis as an acute inpatient. CONCLUSIONS A multifaceted knowledge translation intervention failed to reduce the proportion of early dialysis starts in patients with CKD followed in multidisciplinary clinics. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER ClinicalTrials.gov, NCT02183987. Available at: https://clinicaltrials.gov/ct2/show/NCT02183987.",2021,"A multifaceted knowledge translation intervention failed to reduce the proportion of early dialysis starts in patients with CKD followed in multidisciplinary clinics. ","['Participants included adults who had at least 3 months of predialysis care and who started dialysis in the first year after the intervention', 'Early Dialysis Initiation', 'patients with CKD followed in multidisciplinary clinics', 'Canada between October 2014 and November 2015', '3424 patients initiating dialysis in the 1-year follow-up period']",['Knowledge-Translation Intervention'],"['proportion of individuals initiating dialysis', 'proportion of patients who initiated dialysis early', 'proportion of early dialysis starts']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C3494164', 'cui_str': 'Knowledge Translation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]",55.0,0.0577902,"A multifaceted knowledge translation intervention failed to reduce the proportion of early dialysis starts in patients with CKD followed in multidisciplinary clinics. ","[{'ForeName': 'Navdeep', 'Initials': 'N', 'LastName': 'Tangri', 'Affiliation': 'Department of Internal Medicine, University of Manitoba, Max Rady College of Medicine, Winnipeg, Manitoba, Canada ntangri@sogh.mb.ca.'}, {'ForeName': 'Amit X', 'Initials': 'AX', 'LastName': 'Garg', 'Affiliation': 'Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Ferguson', 'Affiliation': 'Department of Internal Medicine, University of Manitoba, Max Rady College of Medicine, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Dixon', 'Affiliation': 'Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Rigatto', 'Affiliation': 'Department of Internal Medicine, University of Manitoba, Max Rady College of Medicine, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Selina', 'Initials': 'S', 'LastName': 'Allu', 'Affiliation': 'Department of Medicine and Community Health Sciences, Libin Cardiovascular Institute, Calgary, Canada.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Chau', 'Affiliation': 'Department of Internal Medicine, University of Manitoba, Max Rady College of Medicine, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Komenda', 'Affiliation': 'Department of Internal Medicine, University of Manitoba, Max Rady College of Medicine, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Naimark', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Gihad E', 'Initials': 'GE', 'LastName': 'Nesrallah', 'Affiliation': 'Institute for Clinical Evaluative Sciences, London, Ontario, Canada.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Soroka', 'Affiliation': 'Division of Nephrology, Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Beaulieu', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Ahsan', 'Initials': 'A', 'LastName': 'Alam', 'Affiliation': 'Division of Nephrology, Department of Medicine, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'S Joseph', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Manish M', 'Initials': 'MM', 'LastName': 'Sood', 'Affiliation': 'The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Braden', 'Initials': 'B', 'LastName': 'Manns', 'Affiliation': 'Department of Medicine and Community Health Sciences, Libin Cardiovascular Institute, Calgary, Canada.'}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2020091254'] 3911,33858976,Effects of denosumab in Japanese rheumatoid arthritis patients treated with conventional anti-rheumatic drugs: 36-month extension of a phase 3 study.,"OBJECTIVE To evaluate safety and efficacy of long-term denosumab 60 mg every 6 (Q6M) or 3 months (Q3M) in rheumatoid arthritis (RA) patients. METHODS This 12-month, randomised, double-blind, placebo-controlled, multicentre phase 3 trial with an open-label extension period from 12 to 36 months (DESIRABLE) enrolled Japanese RA patients treated with placebo for 12 months then denosumab Q6M (P/Q6M) or denosumab Q3M (P/Q3M); denosumab Q6M for 36 months (Q6M/Q6M); or denosumab Q3M for 36 months (Q3M/Q3M). Efficacy was assessed by van der Heijde modified total Sharp (mTSS), bone erosion (ES), and joint space narrowing (JSN) scores. RESULTS Long-term treatment better maintained mTSS and ES suppression in the P/Q3M and Q3M/Q3M versus P/Q6M and Q6M/Q6M groups; changes from baseline in total mTSS at 36 months were 2.8 (standard error 0.4), 1.7 (0.3), 3.0 (0.4), and 2.4 (0.3), respectively; corresponding changes in ES were 1.3 (0.2), 0.4 (0.2), 1.4 (0.2), and 1.1 (0.2). No JSN effect was observed. Bone mineral density consistently increased in all groups after denosumab initiation, regardless of concomitant glucocorticoid administration. Serum C-telopeptide of type I collagen decreased rapidly at 1-month post-denosumab administration (both in the initial 12- month [Q3M, Q6M groups] and long-term treatment [P/Q3M, P/Q6M groups] phases). Adverse event incidence leading to study drug discontinuation was similar across treatment groups. CONCLUSION Denosumab treatment maintained inhibition of progression of joint destruction up to 36 months. Based on effects on ES progression, higher dosing frequency at an earlier treatment stage may be needed to optimise treatment. Denosumab was generally well tolerated.",2021,"RESULTS Long-term treatment better maintained mTSS and ES suppression in the P/Q3M and Q3M/Q3M versus P/Q6M and Q6M/Q6M groups; changes from baseline in total mTSS at 36 months were 2.8 (standard error 0.4),","['12 to 36 months (DESIRABLE) enrolled Japanese RA patients treated with', 'rheumatoid arthritis (RA) patients', 'Japanese rheumatoid arthritis patients treated with']","['conventional anti-rheumatic drugs', 'denosumab', 'long-term denosumab', 'placebo', 'denosumab Q6M (P/Q6M) or denosumab Q3M (P/Q3M); denosumab Q6M for 36 months (Q6M/Q6M); or denosumab Q3M', 'Denosumab']","['Bone mineral density', 'tolerated', 'progression of joint destruction', 'safety and efficacy', 'Efficacy', 'Serum C-telopeptide of type', 'van der Heijde modified total Sharp (mTSS), bone erosion (ES), and joint space narrowing (JSN) scores', 'maintained mTSS and ES suppression']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0003191', 'cui_str': 'Antirheumatic agent'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0585339', 'cui_str': 'Every six months'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0541875', 'cui_str': 'Joint destruction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0557775', 'cui_str': 'Van'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1444775', 'cui_str': 'Sharp sensation quality'}, {'cui': 'C0587240', 'cui_str': 'Bone erosion'}, {'cui': 'C0224497', 'cui_str': 'Articular space'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",,0.114262,"RESULTS Long-term treatment better maintained mTSS and ES suppression in the P/Q3M and Q3M/Q3M versus P/Q6M and Q6M/Q6M groups; changes from baseline in total mTSS at 36 months were 2.8 (standard error 0.4),","[{'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan; Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan; Department of Orthopedics and Rheumatology, Kindai University Nara Hospital, Ikoma, Japan; Director of Rheumatology, Sanno Medical Center, Tokyo, Japan; Department of Biochemistry, Osaka University Graduate School of Dentistry, Osaka, Japan; Orthopedic Surgery and Spinal Surgery, The University of Tokyo, Tokyo, Japan; Daiichi Sankyo Co., Ltd, Japan; Departments of Radiology, Medicine and Orthopedic Surgery, University of California, California, USA; Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands. This study was funded by Daiichi Sankyo Co., Ltd. Address correspondence to Yoshiya Tanaka First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan. E-mail: tanaka@med.uoeh-u.ac.jp.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan; Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan; Department of Orthopedics and Rheumatology, Kindai University Nara Hospital, Ikoma, Japan; Director of Rheumatology, Sanno Medical Center, Tokyo, Japan; Department of Biochemistry, Osaka University Graduate School of Dentistry, Osaka, Japan; Orthopedic Surgery and Spinal Surgery, The University of Tokyo, Tokyo, Japan; Daiichi Sankyo Co., Ltd, Japan; Departments of Radiology, Medicine and Orthopedic Surgery, University of California, California, USA; Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands. This study was funded by Daiichi Sankyo Co., Ltd. Address correspondence to Yoshiya Tanaka First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan. E-mail: tanaka@med.uoeh-u.ac.jp.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Soen', 'Affiliation': 'First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan; Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan; Department of Orthopedics and Rheumatology, Kindai University Nara Hospital, Ikoma, Japan; Director of Rheumatology, Sanno Medical Center, Tokyo, Japan; Department of Biochemistry, Osaka University Graduate School of Dentistry, Osaka, Japan; Orthopedic Surgery and Spinal Surgery, The University of Tokyo, Tokyo, Japan; Daiichi Sankyo Co., Ltd, Japan; Departments of Radiology, Medicine and Orthopedic Surgery, University of California, California, USA; Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands. This study was funded by Daiichi Sankyo Co., Ltd. Address correspondence to Yoshiya Tanaka First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan. E-mail: tanaka@med.uoeh-u.ac.jp.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Yamanaka', 'Affiliation': 'First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan; Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan; Department of Orthopedics and Rheumatology, Kindai University Nara Hospital, Ikoma, Japan; Director of Rheumatology, Sanno Medical Center, Tokyo, Japan; Department of Biochemistry, Osaka University Graduate School of Dentistry, Osaka, Japan; Orthopedic Surgery and Spinal Surgery, The University of Tokyo, Tokyo, Japan; Daiichi Sankyo Co., Ltd, Japan; Departments of Radiology, Medicine and Orthopedic Surgery, University of California, California, USA; Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands. This study was funded by Daiichi Sankyo Co., Ltd. Address correspondence to Yoshiya Tanaka First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan. E-mail: tanaka@med.uoeh-u.ac.jp.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Yoneda', 'Affiliation': 'First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan; Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan; Department of Orthopedics and Rheumatology, Kindai University Nara Hospital, Ikoma, Japan; Director of Rheumatology, Sanno Medical Center, Tokyo, Japan; Department of Biochemistry, Osaka University Graduate School of Dentistry, Osaka, Japan; Orthopedic Surgery and Spinal Surgery, The University of Tokyo, Tokyo, Japan; Daiichi Sankyo Co., Ltd, Japan; Departments of Radiology, Medicine and Orthopedic Surgery, University of California, California, USA; Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands. This study was funded by Daiichi Sankyo Co., Ltd. Address correspondence to Yoshiya Tanaka First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan. E-mail: tanaka@med.uoeh-u.ac.jp.'}, {'ForeName': 'Sakae', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan; Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan; Department of Orthopedics and Rheumatology, Kindai University Nara Hospital, Ikoma, Japan; Director of Rheumatology, Sanno Medical Center, Tokyo, Japan; Department of Biochemistry, Osaka University Graduate School of Dentistry, Osaka, Japan; Orthopedic Surgery and Spinal Surgery, The University of Tokyo, Tokyo, Japan; Daiichi Sankyo Co., Ltd, Japan; Departments of Radiology, Medicine and Orthopedic Surgery, University of California, California, USA; Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands. This study was funded by Daiichi Sankyo Co., Ltd. Address correspondence to Yoshiya Tanaka First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan. E-mail: tanaka@med.uoeh-u.ac.jp.'}, {'ForeName': 'Takaya', 'Initials': 'T', 'LastName': 'Nitta', 'Affiliation': 'First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan; Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan; Department of Orthopedics and Rheumatology, Kindai University Nara Hospital, Ikoma, Japan; Director of Rheumatology, Sanno Medical Center, Tokyo, Japan; Department of Biochemistry, Osaka University Graduate School of Dentistry, Osaka, Japan; Orthopedic Surgery and Spinal Surgery, The University of Tokyo, Tokyo, Japan; Daiichi Sankyo Co., Ltd, Japan; Departments of Radiology, Medicine and Orthopedic Surgery, University of California, California, USA; Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands. This study was funded by Daiichi Sankyo Co., Ltd. Address correspondence to Yoshiya Tanaka First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan. E-mail: tanaka@med.uoeh-u.ac.jp.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Okubo', 'Affiliation': 'First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan; Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan; Department of Orthopedics and Rheumatology, Kindai University Nara Hospital, Ikoma, Japan; Director of Rheumatology, Sanno Medical Center, Tokyo, Japan; Department of Biochemistry, Osaka University Graduate School of Dentistry, Osaka, Japan; Orthopedic Surgery and Spinal Surgery, The University of Tokyo, Tokyo, Japan; Daiichi Sankyo Co., Ltd, Japan; Departments of Radiology, Medicine and Orthopedic Surgery, University of California, California, USA; Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands. This study was funded by Daiichi Sankyo Co., Ltd. Address correspondence to Yoshiya Tanaka First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan. E-mail: tanaka@med.uoeh-u.ac.jp.'}, {'ForeName': 'Harry K', 'Initials': 'HK', 'LastName': 'Genant', 'Affiliation': 'First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan; Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan; Department of Orthopedics and Rheumatology, Kindai University Nara Hospital, Ikoma, Japan; Director of Rheumatology, Sanno Medical Center, Tokyo, Japan; Department of Biochemistry, Osaka University Graduate School of Dentistry, Osaka, Japan; Orthopedic Surgery and Spinal Surgery, The University of Tokyo, Tokyo, Japan; Daiichi Sankyo Co., Ltd, Japan; Departments of Radiology, Medicine and Orthopedic Surgery, University of California, California, USA; Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands. This study was funded by Daiichi Sankyo Co., Ltd. Address correspondence to Yoshiya Tanaka First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan. E-mail: tanaka@med.uoeh-u.ac.jp.'}, {'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan; Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan; Department of Orthopedics and Rheumatology, Kindai University Nara Hospital, Ikoma, Japan; Director of Rheumatology, Sanno Medical Center, Tokyo, Japan; Department of Biochemistry, Osaka University Graduate School of Dentistry, Osaka, Japan; Orthopedic Surgery and Spinal Surgery, The University of Tokyo, Tokyo, Japan; Daiichi Sankyo Co., Ltd, Japan; Departments of Radiology, Medicine and Orthopedic Surgery, University of California, California, USA; Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands. This study was funded by Daiichi Sankyo Co., Ltd. Address correspondence to Yoshiya Tanaka First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan. E-mail: tanaka@med.uoeh-u.ac.jp.'}]",The Journal of rheumatology,['10.3899/jrheum.201376'] 3912,33858965,Effects of advertising features on smokers' and non-smokers' perceptions of a reduced nicotine cigarette modified risk tobacco product.,"INTRODUCTION Research is needed to determine the impact of marketing on perceptions and use of reduced nicotine content (RNC) cigarettes, particularly as US regulators have permitted the sale of an RNC cigarette modified risk tobacco product (MRTP) that seeks further authorisation to advertise using modified risk claims. This study examined the effects of two advertising elements (product name and disclaimer content) on perceptions of an RNC cigarette MRTP. METHODS Adult participants (n=807, 28.7% smokers, 58.2% male, 74.2% non-Latinx white) completed an online MTurk survey. Participants were randomised to view one of six RNC cigarette advertisements, using a 2×3 between-subject factorial design to manipulate product name ('Moonlight' vs 'Moonrise') and disclaimer content (industry-proposed: 'Nicotine is addictive. Less nicotine does NOT mean a safer cigarette' vs focused: 'Less nicotine does NOT mean a safer cigarette' vs no content), then completed recall and product perception questionnaires. RESULTS All participants who viewed the industry-proposed disclaimer (vs no content) perceived greater addiction risk (p's<0.05). Non-smokers who viewed this disclaimer also perceived greater health risks and held fewer false beliefs (p's<0.05). Smokers who viewed Moonlight (vs Moonrise) ads perceived lower health risks (p<0.05). CONCLUSIONS Disclaimer content may effectively inform consumers about addiction risk of a new RNC cigarette MRTP, and further inform non-smokers about health risks. This element, however, had little effect on perceived health risks among smokers, among whom the Moonlight product name was associated with health risk misperceptions similar to the banned 'light' descriptor.",2021,"Smokers who viewed Moonlight (vs Moonrise) ads perceived lower health risks (p<0.05). ","[""All participants who viewed the industry-proposed disclaimer (vs no content) perceived greater addiction risk (p's<0.05). Non-smokers who viewed this disclaimer also perceived greater health risks and held fewer false beliefs (p's<0.05"", ""smokers' and non-smokers' perceptions of a reduced nicotine cigarette modified risk tobacco product"", 'Adult participants (n=807, 28.7% smokers, 58.2% male, 74.2% non-Latinx white) completed an online MTurk survey']","['nicotine', 'two advertising elements (product name and disclaimer content', ""manipulate product name ('Moonlight' vs 'Moonrise') and disclaimer content (industry-proposed: 'Nicotine""]",['lower health risks'],"[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0021267', 'cui_str': 'Industry'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0205237', 'cui_str': 'False'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0001690', 'cui_str': 'Advertising as Topic'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C2708250', 'cui_str': 'Product name'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0681123', 'cui_str': 'Moonlighting'}, {'cui': 'C0021267', 'cui_str': 'Industry'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.098634,"Smokers who viewed Moonlight (vs Moonrise) ads perceived lower health risks (p<0.05). ","[{'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Mercincavage', 'Affiliation': 'Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania, USA melmer@upenn.edu.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Pacek', 'Affiliation': 'Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Thrasher', 'Affiliation': 'Health Promotion, Education, and Behavior, School of Public Health, University of South Carolina, Columbia, South Carolina, USA.'}, {'ForeName': 'Joseph N', 'Initials': 'JN', 'LastName': 'Cappella', 'Affiliation': 'University of Pennsylvania-Rutgers University Tobacco Center of Regulatory Science, Philadelphia, PA, USA.'}, {'ForeName': 'Cristine', 'Initials': 'C', 'LastName': 'Delnevo', 'Affiliation': 'University of Pennsylvania-Rutgers University Tobacco Center of Regulatory Science, Philadelphia, PA, USA.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Donny', 'Affiliation': 'University of Pennsylvania-Rutgers University Tobacco Center of Regulatory Science, Philadelphia, PA, USA.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Strasser', 'Affiliation': 'Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}]",Tobacco control,['10.1136/tobaccocontrol-2020-056441'] 3913,33858875,"Protocol of a 12-month multifactorial eHealth programme targeting balance, dual-tasking and mood to prevent falls in older people: the StandingTall + randomised controlled trial.","INTRODUCTION Falls have a multifactorial aetiology, which may limit the effectiveness of the common approach of exercise as the sole intervention strategy. Multifactorial interventions could be more effective in people at high risk of falling; however, the focus of such interventions has traditionally been quite narrow. This paper describes the design of a randomised controlled trial that will evaluate the effectiveness of an eHealth programme, which addresses cumulative effects of key fall-risk factors across the triad of physical, affective and cognitive functions on falls in older people. METHODS AND ANALYSIS 518 older people aged 65 years and over with high fall risk, defined as having a history of falls in the past 6 months, self-reported fear of falling or being aged 80 years or over, will be recruited via local advertisements, newsletters and presentations, and randomised to an intervention or health education control group. The intervention comprises balance exercise, cognitive-motor exercise and cognitive-behavioural therapy, with their dosage based on participant's baseline balance, executive function and mood. The primary outcome is the rate of falls in the 12 months after randomisation. Secondary outcomes at 6 and 12 months comprise programme adherence, healthcare use, physical activity, balance and mobility, cognitive function, psychological well-being, quality of life, health literacy and user experience and attitudes towards the programme. Data will be analysed following intention to treat to gauge real-world effectiveness. We will further determine complier averaged causal effects to correct for varying adherence and conduct economic analyses to gain insight into cost-effectiveness and cost-utility. ETHICS AND DISSEMINATION Ethical approval was obtained from the University of New South Wales (UNSW) Human Research Ethics Committee in December 2017. Outcomes will be disseminated via peer-reviewed articles, conference presentations, community events and media releases. TRIAL REGISTRATION NUMBER ACTRN12619000540112.",2021,"Secondary outcomes at 6 and 12 months comprise programme adherence, healthcare use, physical activity, balance and mobility, cognitive function, psychological well-being, quality of life, health literacy and user experience and attitudes towards the programme.","['older people', '518 older people aged 65 years and over with high fall risk, defined as having a history of falls in the past 6 months, self-reported fear of falling or being aged 80 years or over, will be recruited via local advertisements, newsletters and presentations, and randomised to an intervention or health education control group']","['eHealth programme', 'balance exercise, cognitive-motor exercise and cognitive-behavioural therapy']","['programme adherence, healthcare use, physical activity, balance and mobility, cognitive function, psychological well-being, quality of life, health literacy and user experience and attitudes towards the programme', 'rate of falls']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1561668', 'cui_str': 'History of fall'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0027988', 'cui_str': 'Newsletters'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",,0.0491037,"Secondary outcomes at 6 and 12 months comprise programme adherence, healthcare use, physical activity, balance and mobility, cognitive function, psychological well-being, quality of life, health literacy and user experience and attitudes towards the programme.","[{'ForeName': 'Kimberley S', 'Initials': 'KS', 'LastName': 'van Schooten', 'Affiliation': 'Neuroscience Research Australia, Randwick, New South Wales, Australia.'}, {'ForeName': 'Michele L', 'Initials': 'ML', 'LastName': 'Callisaya', 'Affiliation': 'Peninsula Clinical School, Central Clinical School, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Bridianne', 'Initials': 'B', 'LastName': ""O'Dea"", 'Affiliation': 'The Black Dog Institute and School of Medicine, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lung', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kaarin', 'Initials': 'K', 'LastName': 'Anstey', 'Affiliation': 'Neuroscience Research Australia, Randwick, New South Wales, Australia.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Lord', 'Affiliation': 'Neuroscience Research Australia, Randwick, New South Wales, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Christensen', 'Affiliation': 'The Black Dog Institute and School of Medicine, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Brown', 'Affiliation': 'Neuroscience Research Australia, Randwick, New South Wales, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Chow', 'Affiliation': 'Neuroscience Research Australia, Randwick, New South Wales, Australia.'}, {'ForeName': 'Garth', 'Initials': 'G', 'LastName': 'McInerney', 'Affiliation': 'Neuroscience Research Australia, Randwick, New South Wales, Australia.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Miles', 'Affiliation': 'Neuroscience Research Australia, Randwick, New South Wales, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Ngo', 'Affiliation': 'Neuroscience Research Australia, Randwick, New South Wales, Australia.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Perram', 'Affiliation': 'Neuroscience Research Australia, Randwick, New South Wales, Australia.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Delbaere', 'Affiliation': 'Neuroscience Research Australia, Randwick, New South Wales, Australia k.delbaere@neura.edu.au.'}]",BMJ open,['10.1136/bmjopen-2021-051085'] 3914,33858866,Real-world effects of medications for stroke prevention in atrial fibrillation: protocol for a UK population-based non-interventional cohort study with validation against randomised trial results.,"INTRODUCTION Patients with atrial fibrillation experience an irregular heart rate and have an increased risk of stroke; prophylactic treatment with anticoagulation medication reduces this risk. Direct-acting oral anticoagulants (DOACs) have been approved providing an alternative to vitamin K antagonists such as warfarin. There is interest from regulatory bodies on the effectiveness of medications in routine clinical practice; however, uncertainty remains regarding the suitability of non-interventional data for answering questions on drug effectiveness and on the most suitable methods to be used. In this study, we will use data from Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE)-the pivotal trial for the DOAC apixaban-to validate non-interventional methods for assessing treatment effectiveness of anticoagulants. These methods could then be applied to analyse treatment effectiveness in people excluded from or under-represented in ARISTOTLE. METHODS AND ANALYSIS Patient characteristics from ARISTOTLE will be used to select a cohort of patients with similar baseline characteristics from two UK electronic health record (EHR) databases, Clinical Practice Research Datalink Gold and Aurum (between 1 January 2013 and 31 July 2019). Methods such as propensity score matching and coarsened exact matching will be explored in matching between EHR treatment groups to determine the optimal method of obtaining a balanced cohort.Absolute and relative risk of outcomes in the EHR trial-analogous cohort will be calculated and compared with the ARISTOTLE results; if results are deemed compatible the methods used for matching EHR treatment groups can then be used to examine drug effectiveness over a longer duration of exposure and in special patient groups of interest not studied in the trial. ETHICS AND DISSEMINATION The study has been approved by the Independent Scientific Advisory Committee of the UK Medicines and Healthcare Products Regulatory Agency. Results will be disseminated in scientific publications and at relevant conferences.",2021,Direct-acting oral anticoagulants (DOACs) have been approved providing an alternative to vitamin K antagonists such as warfarin.,"['atrial fibrillation', 'Patient characteristics from ARISTOTLE will be used to select a cohort of patients with similar baseline characteristics from two UK electronic health record (EHR) databases, Clinical Practice Research Datalink Gold and Aurum (between 1 January 2013 and 31 July 2019']",['Direct-acting oral anticoagulants (DOACs'],[],"[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0018026', 'cui_str': 'Gold'}]","[{'cui': 'C3653500', 'cui_str': 'Direct factor Xa inhibitors'}]",[],,0.0896379,Direct-acting oral anticoagulants (DOACs) have been approved providing an alternative to vitamin K antagonists such as warfarin.,"[{'ForeName': 'Emma Maud', 'Initials': 'EM', 'LastName': 'Powell', 'Affiliation': 'Department of Non-communicable Disease Epidemiology, Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK maud.teoh@lshtm.ac.uk.'}, {'ForeName': 'Ian J', 'Initials': 'IJ', 'LastName': 'Douglas', 'Affiliation': 'Department of Non-communicable Disease Epidemiology, Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Gungabissoon', 'Affiliation': 'Epidemiology (Value Evidence and Outcomes), GSK, London, UK.'}, {'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Smeeth', 'Affiliation': 'Department of Non-communicable Disease Epidemiology, Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Wing', 'Affiliation': 'Department of Non-communicable Disease Epidemiology, Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.'}]",BMJ open,['10.1136/bmjopen-2020-042947'] 3915,33858855,"Effects of the SGLT2 Inhibitor Dapagliflozin on Energy Metabolism in Patients With Type 2 Diabetes: A Randomized, Double-Blind Crossover Trial.","OBJECTIVE SGTL2 inhibitors increase urinary glucose excretion and have beneficial effects on cardiovascular and renal outcomes. The underlying mechanism may involve caloric restriction-like metabolic effects due to urinary glucose loss. We investigated the effects of dapagliflozin on 24-h energy metabolism and insulin sensitivity in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS There were 26 patients with type 2 diabetes randomized to a 5-week double-blind, crossover study with a 6- to 8-week washout. Indirect calorimetry was used to measure 24-h energy metabolism and the respiratory exchange ratio (RER), both by whole-room calorimetry and by ventilated hood during a two-step euglycemic-hyperinsulinemic clamp. Results are presented as the differences in least squares mean (95% CI) between treatments. RESULTS Evaluable patients ( n = 24) had a mean (SD) age of 64.2 (4.6) years, BMI of 28.1 (2.4) kg/m 2 , and HbA 1c of 6.9% (0.7) (51.7 [6.8] mmol/mol). Rate of glucose disappearance was unaffected by dapagliflozin, whereas fasting endogenous glucose production (EGP) increased by dapagliflozin (+2.27 [1.39, 3.14] μmol/kg/min, P  < 0.0001). Insulin-induced suppression of EGP (-1.71 [-2.75, -0.63] μmol/kg/min, P = 0.0036) and plasma free fatty acids (-21.93% [-39.31, -4.54], P = 0.016) was greater with dapagliflozin. Twenty-four-hour energy expenditure (-0.11 [-0.24, 0.03] MJ/day) remained unaffected by dapagliflozin, but dapagliflozin reduced the RER during daytime and nighttime, resulting in an increased day-to-nighttime difference in the RER (-0.010 [-0.017, -0.002], P = 0.016). Dapagliflozin treatment resulted in a negative 24-h energy and fat balance (-20.51 [-27.90, -13.12] g/day). CONCLUSIONS Dapagliflozin treatment for 5 weeks resulted in major adjustments of metabolism mimicking caloric restriction, increased fat oxidation, improved hepatic and adipose insulin sensitivity, and improved 24-h energy metabolism.",2021,"Insulin-induced suppression of EGP (-1.71 [-2.75, -0.63] μmol/kg/min, P = 0.0036) and plasma free fatty acids (-21.93% [-39.31, -4.54], P = 0.016) was greater with dapagliflozin.","['26 patients with type 2 diabetes', 'Evaluable patients ( n = 24) had a mean (SD) age of 64.2 (4.6) years, BMI of 28.1 (2.4) kg/m 2 , and HbA 1c of 6.9% (0.7) (51.7 [6.8] mmol/mol', 'Patients With Type 2 Diabetes', 'patients with type 2 diabetes']","['dapagliflozin', 'SGLT2 Inhibitor Dapagliflozin', 'Dapagliflozin']","['RER during daytime and nighttime, resulting in an increased day-to-nighttime difference in the RER', '24-h energy metabolism and insulin sensitivity', 'negative 24-h energy and fat balance', 'Rate of glucose disappearance', 'Insulin-induced suppression of EGP', '24-h energy metabolism and the respiratory exchange ratio (RER', 'metabolism mimicking caloric restriction, increased fat oxidation, improved hepatic and adipose insulin sensitivity, and improved 24-h energy metabolism', 'urinary glucose excretion', 'fasting endogenous glucose production (EGP', 'Energy Metabolism', 'plasma free fatty acids']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517826', 'cui_str': '6.9'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}]","[{'cui': 'C0230779', 'cui_str': 'Granular endoplasmic reticulum'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0903677', 'cui_str': 'TACSTD1 protein, human'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}]",26.0,0.175956,"Insulin-induced suppression of EGP (-1.71 [-2.75, -0.63] μmol/kg/min, P = 0.0036) and plasma free fatty acids (-21.93% [-39.31, -4.54], P = 0.016) was greater with dapagliflozin.","[{'ForeName': 'Yvo J M', 'Initials': 'YJM', 'LastName': 'Op den Kamp', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'de Ligt', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Dautzenberg', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Kornips', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Esterline', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD.'}, {'ForeName': 'Matthijs K C', 'Initials': 'MKC', 'LastName': 'Hesselink', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'Hoeks', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Vera B', 'Initials': 'VB', 'LastName': 'Schrauwen-Hinderling', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Havekes', 'Affiliation': 'Internal Medicine, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Oscarsson', 'Affiliation': 'BioPharmaceuticals R&D, Late-Stage Development, Cardiovascular, Renal and Metabolism, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Phielix', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schrauwen', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands p.schrauwen@maastrichtuniversity.nl.'}]",Diabetes care,['10.2337/dc20-2887'] 3916,33858791,"Reply to ""Anesthesia using microcannula and sharp needle in upper blepharoplasty: A randomized, double-blind clinical trial evaluating pain, bruising, and ecchymosis"".",,2021,,['upper blepharoplasty'],['Anesthesia using microcannula and sharp needle'],[],"[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0197213', 'cui_str': 'Repair of eyelid'}]","[{'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C1444775', 'cui_str': 'Sharp sensation quality'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}]",[],,0.743429,,"[{'ForeName': 'Conor M', 'Initials': 'CM', 'LastName': 'Sugrue', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, St Vincent's Hospital, 41 Victoria Parade, Fitzroy, VIC 3065, Australia; Horizon Plastic Surgery, Melbourne, Victoria, Australia. Electronic address: conormsugrue@rcsi.ie.""}, {'ForeName': 'Damien G', 'Initials': 'DG', 'LastName': 'Grinsell', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, St Vincent's Hospital, 41 Victoria Parade, Fitzroy, VIC 3065, Australia; Horizon Plastic Surgery, Melbourne, Victoria, Australia.""}]","Journal of plastic, reconstructive & aesthetic surgery : JPRAS",['10.1016/j.bjps.2021.03.053'] 3917,33858775,"Stress and Depressive Symptoms Are Not Associated with Overall Diet Quality, But Are Associated with Aspects of Diet Quality in Pregnant Women in South Carolina.","BACKGROUND Poor mental health may hinder diet quality in pregnancy. OBJECTIVE This study 1) examined whether stress and depressive symptoms are associated with diet quality (via Healthy Eating Index [HEI] 2015 total scores and dietary intake of food groups/nutrients that align with HEI-2015 components) and 2) tested race as a moderator in the relationship between mental health and diet quality. DESIGN This was a cross-sectional analysis of baseline data from a randomized controlled trial collected January 2015 through January 2019 in Columbia, South Carolina. Trained staff administered demographic and psychosocial questionnaires and conducted anthropometric measures. Participants completed two 24-hour dietary recalls, which were self-administered (one on-site, one at home). PARTICIPANTS The Health in Pregnancy and Postpartum study was a randomized controlled trial targeting excessive gestational weight gain among pregnant women with overweight/obesity (N = 228). MAIN OUTCOME MEASURES The HEI-2015 total scores and food groups/nutrients that align with HEI-2015 were calculated. STATISTICAL ANALYSES PERFORMED Multiple linear regression models were used to estimate the relationship between mental health and HEI-2015 total scores and dietary intake of food groups or nutrients that align with HEI-2015 components. Multiplicative interaction terms of stress or depressive symptoms with race were used to determine moderation. RESULTS Participants' diet quality was suboptimal (M = 52.0 ± 11.7; range, 27-85). Stress was negatively associated with HEI-2015 total scores (crude but not adjusted model). Stress scores were positively associated with consumption of dairy, refined grains, and added sugars and negatively associated with total protein foods. Depressive symptoms were positively associated with consumption of dairy, refined grains, and saturated fats. Race was not a moderator. CONCLUSIONS Diet quality was poor overall, but stress and depressive symptoms were not associated with HEI-2015 total scores in adjusted models. Excluding dairy, stress and depressive symptoms were associated with the consumption of food groups or nutrients related to worse diet quality. These relationships should be examined longitudinally to help establish causality and inform future interventions.",2021,"Stress scores were positively associated with consumption of dairy, refined grains, and added sugars and negatively associated with total protein foods.","['Pregnant Women in South Carolina', 'January 2015 through January 2019 in Columbia, South Carolina', 'pregnant women with overweight/obesity (N\xa0= 228']",[],"['stress and depressive symptoms', 'diet quality', 'HEI-2015 total scores', 'excessive gestational weight gain', 'Stress scores', 'Depressive symptoms', 'HEI-2015 total scores and food groups/nutrients that align with HEI-2015', 'Excluding dairy, stress and depressive symptoms', 'diet quality (via Healthy Eating Index']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0037716', 'cui_str': 'South Carolina'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",[],"[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C2369992', 'cui_str': 'Align'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}]",,0.100139,"Stress scores were positively associated with consumption of dairy, refined grains, and added sugars and negatively associated with total protein foods.","[{'ForeName': 'Alycia K', 'Initials': 'AK', 'LastName': 'Boutté', 'Affiliation': ''}, {'ForeName': 'Gabrielle M', 'Initials': 'GM', 'LastName': 'Turner-McGrievy', 'Affiliation': ''}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wilcox', 'Affiliation': ''}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Jan M', 'Initials': 'JM', 'LastName': 'Eberth', 'Affiliation': ''}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Kaczynski', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2021.02.025'] 3918,33858741,The time of postoperative corticosteroid injection can be individualized after arthroscopic rotator cuff repair.,"BACKGROUND Intra-articular corticosteroid injection is an effective treatment for pain and to improve the range of motion (ROM) of the shoulder joint. However, consideration of when it would be effective to inject corticosteroids after rotator cuff repair is more limited. The purpose of this study was to compare the outcomes of corticosteroids injection given at 4 and 8 weeks after arthroscopic rotator cuff repair. METHODS Between December 2016 and January 2018, 42 patients who underwent arthroscopic supraspinatus tendon repair were enrolled. Nineteen patients received 40 mg of triamcinolone injection 4 weeks after surgery (group 1), while 23 patients received the same injection 8 weeks after surgery (group 2). Clinical outcome was evaluated using ROM, American Shoulder and Elbow Surgeons (ASES) score, Constant score, Korean Shoulder score, and a visual analog scale (VAS) score before surgery and at 3, 6, and 12 months after surgery. Tendon integrity was assessed with magnetic resonance imaging (MRI) and sonography at 12 months after surgery. RESULTS Significant improvements in pain and functional scores were observed at the last follow-up in both groups (p < 0.05). There was no significant difference in VAS pain score between the two groups at any time point after surgery (p > 0.05). Functional scores and ROM in all directions also showed no statistical difference between the two groups (p > 0.05). Retears of the repaired tendon, assessed at 12 months postoperatively, were observed in two patients from group 1 (10.5%) and two patients from group 2 (8.7%), thus indicating no significant difference between the two groups (p > 0.05). CONCLUSION Since there was no significant difference in clinical outcomes and tendon integrity, postoperative corticosteroid injection can be individualized according to the patient for 4-8 weeks after the rotator cuff repair.",2021,Functional scores and ROM in all directions also showed no statistical difference between the two groups (p > 0.05).,"['Between December 2016 and January 2018, 42 patients who underwent arthroscopic supraspinatus tendon repair were enrolled']","['triamcinolone injection', 'magnetic resonance imaging (MRI) and sonography', 'corticosteroids injection']","['Tendon integrity', 'Functional scores and ROM', 'ROM, American Shoulder and Elbow Surgeons (ASES) score, Constant score, Korean Shoulder score, and a visual analog scale (VAS) score', 'clinical outcomes and tendon integrity', 'pain and functional scores', 'VAS pain score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0224868', 'cui_str': 'Structure of tendon of supraspinatus muscle'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C4084816', 'cui_str': 'Triamcinolone Injection'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}]",,0.0746414,Functional scores and ROM in all directions also showed no statistical difference between the two groups (p > 0.05).,"[{'ForeName': 'Sung-Hyun', 'Initials': 'SH', 'LastName': 'Cho', 'Affiliation': ""Department of Orthopedic Surgery, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Taeyong', 'Initials': 'T', 'LastName': 'Park', 'Affiliation': ""Department of Orthopedic Surgery, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Yang-Soo', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': ""Department of Orthopedic Surgery, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea. Electronic address: kysoos@catholic.ac.kr.""}]",Journal of orthopaedic science : official journal of the Japanese Orthopaedic Association,['10.1016/j.jos.2021.02.010'] 3919,33858718,"Ten-year follow-up on efficacy, immunogenicity and safety of two doses of a combined measles-mumps-rubella-varicella vaccine or one dose of monovalent varicella vaccine: Results from five East European countries.","BACKGROUND We assessed the 10-year efficacy, immunogenicity and safety of two doses of a combined measles-mumps-rubella-varicella vaccine (MMRV) or one dose of a monovalent varicella vaccine (V) in children from Czech Republic, Lithuania, Poland, Romania and Slovakia. METHODS This was a phase IIIB follow-up of an observer-blind, randomized, controlled trial (NCT00226499). In phase A, healthy children aged 12-22 months from 10 European countries were randomized in a 3:3:1 ratio to receive two doses of MMRV (MMRV group), one dose of MMR followed by one dose of V (MMR + V group), or two doses of MMR (MMR; control group), 42 days apart. Vaccine efficacy (VE) against varicella (confirmed by viral DNA detection or epidemiological link and clinical assessment) was calculated with 95% confidence intervals using Cox proportional hazards regression model. Immunogenicity was assessed as seropositivity rates and geometric mean concentrations (GMCs). Solicited and unsolicited adverse events (AEs) and serious AEs (SAEs) were recorded. RESULTS A total of 3705 children were vaccinated (1590, MMRV group; 1586, MMR + V group; 529, MMR group). There were 663 confirmed varicella cases (47, MMRV group; 349, MMR + V group; 267, MMR group). VE ranged between 95.4% (Lithuania) and 97.4% (Slovakia) in the MMRV group and between 59.3% (Lithuania) and 74% (Slovakia) in the MMR + V group. At year 10, seropositivity rates were 99.5%-100% in the MMRV group, 98%-100% in the MMR + V group and 50%-100% in the MMR control group, and the anti-VZV antibody GMCs were comparable between MMRV and MMR + V groups. The occurrence of solicited and unsolicited AEs was similar across groups and no SAE was considered as vaccination-related. No new safety concerns were identified. CONCLUSIONS Our results indicated that two doses of varicella zoster virus-containing vaccine provided better protection than one dose against varicella and induced antibody responses that persisted 10 years post-vaccination.",2021,Our results indicated that two doses of varicella zoster virus-containing vaccine provided better protection than one dose against varicella and induced antibody responses that persisted 10 years post-vaccination.,"['children from Czech Republic, Lithuania, Poland, Romania and Slovakia', 'healthy children aged 12-22\xa0months from 10 European countries', '3705 children were vaccinated (1590, MMRV group; 1586, MMR\xa0+\xa0V group; 529, MMR group']","['combined measles-mumps-rubella-varicella vaccine or one dose of monovalent varicella vaccine', 'combined measles-mumps-rubella-varicella vaccine (MMRV', 'monovalent varicella vaccine (V', 'MMRV (MMRV group), one dose of MMR followed by one dose of V (MMR\xa0+\xa0V group), or two doses of MMR']","['Immunogenicity', 'efficacy, immunogenicity and safety', 'Solicited and unsolicited adverse events (AEs) and serious AEs (SAEs', 'Vaccine efficacy (VE) against varicella', 'occurrence of solicited and unsolicited AEs', 'seropositivity rates and geometric mean concentrations (GMCs', 'seropositivity rates', '10-year efficacy, immunogenicity and safety', 'antibody responses']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0206578', 'cui_str': 'Czech republic'}, {'cui': 'C0023879', 'cui_str': 'Lithuania'}, {'cui': 'C0032356', 'cui_str': 'Poland'}, {'cui': 'C0035826', 'cui_str': 'Romania'}, {'cui': 'C0206579', 'cui_str': 'Slovakia'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C0450360', 'cui_str': '3705'}, {'cui': 'C0035920', 'cui_str': 'Rubella'}, {'cui': 'C0078048', 'cui_str': 'Varicella virus vaccine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006416', 'cui_str': 'Burma'}, {'cui': 'C4517806', 'cui_str': '529'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0035920', 'cui_str': 'Rubella'}, {'cui': 'C0078048', 'cui_str': 'Varicella virus vaccine'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006416', 'cui_str': 'Burma'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0008049', 'cui_str': 'Varicella'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}]",3705.0,0.253116,Our results indicated that two doses of varicella zoster virus-containing vaccine provided better protection than one dose against varicella and induced antibody responses that persisted 10 years post-vaccination.,"[{'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Prymula', 'Affiliation': 'Charles University, Faculty of Medicine, Hradec Kralove, Czech Republic. Electronic address: Prymula@seznam.cz.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Povey', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: michael.x.povey@gsk.com.'}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'Brzostek', 'Affiliation': 'Poradnia Chorob Zakaznych ZOZ Debica, Debica, Poland. Electronic address: jerzy_br@poczta.onet.pl.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Cabrnochova', 'Affiliation': 'Paediatric Centre, Prague, Czech Republic. Electronic address: hana@cabrnoch.cz.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Chlibek', 'Affiliation': 'University of Defence, Faculty of Military Health Sciences, Hradec Kralove, Czech Republic. Electronic address: roman.chlibek@unob.cz.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Czajka', 'Affiliation': ""Faculty of Medicine, University of Rzeszow, Rzeszow, Poland and Infectious Diseases Outpatient Clinic, The St. Louis Regional Specialised Children's Hospital, Krakow, Poland. Electronic address: hanna.czajka@onet.pl.""}, {'ForeName': 'Giedra', 'Initials': 'G', 'LastName': 'Leviniene', 'Affiliation': 'Pediatric Clinic, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Sorin', 'Initials': 'S', 'LastName': 'Man', 'Affiliation': 'University of Medicine and Pharmacy ""Iuliu Hatieganu"", Cluj-Napoca, Romania.'}, {'ForeName': 'Mihai', 'Initials': 'M', 'LastName': 'Neamtu', 'Affiliation': 'Lucian Blaga University of Sibiu, Faculty of Medicine, Sibiu, Romania. Electronic address: mihai.neamtu@ulbsibiu.ro.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Pazdiora', 'Affiliation': 'Department of Epidemiology, Medical Faculty Pilsen of Charles University, Czech Republic. Electronic address: PAZDIORA@fnplzen.cz.'}, {'ForeName': 'Doina', 'Initials': 'D', 'LastName': 'Plesca', 'Affiliation': 'Pediatrics, University of Medicine and Pharmacy ""Carol Davila"", Bucharest, Romania.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Ruzkova', 'Affiliation': 'Pediatric Office Dr. Renata Ruzkova, Prague, Czech Republic. Electronic address: drruzkova@email.cz.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Stefkovicova', 'Affiliation': 'Faculty of Health Care, Alexander Dubcek University of Trencín, Trencín, Slovakia.'}, {'ForeName': 'Vytautas', 'Initials': 'V', 'LastName': 'Usonis', 'Affiliation': ""Clinic of Children's Diseases, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania. Electronic address: vytautas.usonis@mf.vu.lt.""}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Verdanova', 'Affiliation': 'Nemocnice s ambulantni casti, Jindrichuv Hradec, Czech Republic. Electronic address: daniela.verdanova@seznam.cz.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Wysocki', 'Affiliation': 'University of Medical Sciences, Poznan, Poland. Electronic address: jwysocki@ump.edu.pl.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Casabona', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: GIACOMO.X.CASABONA@GSK.COM.'}, {'ForeName': 'Md Ahsan', 'Initials': 'MA', 'LastName': 'Habib', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: AHSAN.M.HABIB@GSK.COM.'}]",Vaccine,['10.1016/j.vaccine.2021.03.085'] 3920,33858668,Commentary on early enteral feeding versus traditional feeding in neonatal congenital gastrointestinal malformation undergoing intestinal anastomosis: A randomized multicenter controlled trial of an enhanced recovery after surgery (ERAS) component.,"This is a Commentary on ""Enhanced Enteral Feeding Versus Traditional Feeding in Neonatal Congenital Gastrointestinal Malformation Undergoing Intestinal Anastomosis: A Randomized Multicenter Controlled Trial of an Enhanced Recovery After Surgery (ERAS) Component"" by Peng Y, Xiao D, Xiao S, et al.",2021,"This is a Commentary on ""Enhanced Enteral Feeding Versus Traditional Feeding in Neonatal Congenital Gastrointestinal Malformation Undergoing Intestinal Anastomosis:","['Neonatal Congenital Gastrointestinal Malformation Undergoing Intestinal Anastomosis', 'neonatal congenital gastrointestinal malformation undergoing intestinal anastomosis']","['Enhanced Recovery', 'early enteral feeding versus traditional feeding', 'Enhanced Enteral Feeding Versus Traditional Feeding']",[],"[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0012241', 'cui_str': 'Congenital anomaly of gastrointestinal tract'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]",[],,0.0784265,"This is a Commentary on ""Enhanced Enteral Feeding Versus Traditional Feeding in Neonatal Congenital Gastrointestinal Malformation Undergoing Intestinal Anastomosis:","[{'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Brindle', 'Affiliation': ""Surgery and Community Health Sciences, University of Calgary, The EQuIS (Efficiency Quality Innovation and Safety), Alberta Children's Hospital, Director-Safe Surgery Safe Systems Program Ariadne Labs, Scientific Director-Province of Alberta Surgery Strategic Care Network, Calgary, Alberta, Canada. Electronic address: Mary.Brindle@albertahealthservices.ca.""}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Heiss', 'Affiliation': ""Emeritus of Surgery and Pediatrics, Children's Healthcare of Atlanta, Emory University School of Medicine, 6088 Millstone Run, Stone Mountain, GA 30087, USA. Electronic address: heisskurt@gmail.com.""}]",Journal of pediatric surgery,['10.1016/j.jpedsurg.2021.03.013'] 3921,33858620,Randomized Trial of Interleukin-6 Receptor Inhibition in Patients With Acute ST-Segment Elevation Myocardial Infarction.,"BACKGROUND Prompt myocardial revascularization with percutaneous coronary intervention (PCI) reduces infarct size and improves outcomes in patients with ST-segment elevation myocardial infarction (STEMI). However, as much as 50% of the loss of viable myocardium may be attributed to the reperfusion injury and the associated inflammatory response. OBJECTIVES This study sought to evaluate the effect of the interleukin-6 receptor inhibitor tocilizumab on myocardial salvage in acute STEMI. METHODS The ASSAIL-MI trial was a randomized, double-blind, placebo-controlled trial conducted at 3 high-volume PCI centers in Norway. Patients admitted with STEMI within 6 h of symptom onset were eligible. Consenting patients were randomized in a 1:1 fashion to promptly receive a single infusion of 280 mg tocilizumab or placebo. The primary endpoint was the myocardial salvage index as measured by magnetic resonance imaging after 3 to 7 days. RESULTS We randomized 101 patients to tocilizumab and 98 patients to placebo. The myocardial salvage index was larger in the tocilizumab group than in the placebo group (adjusted between-group difference 5.6 [95% confidence interval: 0.2 to 11.3] percentage points, p = 0.04). Microvascular obstruction was less extensive in the tocilizumab arm, but there was no significant difference in the final infarct size between the tocilizumab arm and the placebo arm (7.2% vs. 9.1% of myocardial volume, p = 0.08). Adverse events were evenly distributed across the treatment groups. CONCLUSIONS Tocilizumab increased myocardial salvage in patients with acute STEMI. (ASSessing the effect of Anti-IL-6 treatment in Myocardial Infarction [ASSAIL-MI]; NCT03004703).",2021,"Microvascular obstruction was less extensive in the tocilizumab arm, but there was no significant difference in the final infarct size between the tocilizumab arm and the placebo arm (7.2% vs. 9.1% of myocardial volume, p = 0.08).","['and 98 patients to', 'patients with ST-segment elevation myocardial infarction (STEMI', 'patients with acute STEMI', 'Patients', 'Consenting patients', '3 high-volume PCI centers in Norway', '101 patients to', 'Patients admitted with STEMI within 6\xa0h of symptom onset were eligible']","['Anti-IL-6 treatment', 'interleukin-6 receptor inhibitor tocilizumab', 'Interleukin-6 Receptor Inhibition', 'percutaneous coronary intervention (PCI', 'tocilizumab or placebo', 'placebo', 'tocilizumab', 'Tocilizumab']","['Microvascular obstruction', 'Adverse events', 'myocardial salvage', 'myocardial salvage index', 'final infarct size']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0063717', 'cui_str': 'Lymphocyte antigen CD126'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",101.0,0.578203,"Microvascular obstruction was less extensive in the tocilizumab arm, but there was no significant difference in the final infarct size between the tocilizumab arm and the placebo arm (7.2% vs. 9.1% of myocardial volume, p = 0.08).","[{'ForeName': 'Kaspar', 'Initials': 'K', 'LastName': 'Broch', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway; K. G. Jebsen Cardiac Research Centre and Centre for Heart Failure Research, University of Oslo, Oslo, Norway. Electronic address: sbbrok@ous-hf.no.'}, {'ForeName': 'Anne Kristine', 'Initials': 'AK', 'LastName': 'Anstensrud', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Sindre', 'Initials': 'S', 'LastName': 'Woxholt', 'Affiliation': ""Clinic of Cardiology, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway; Department of Circulation and Medical Imaging, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.""}, {'ForeName': 'Kapil', 'Initials': 'K', 'LastName': 'Sharma', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Ullevål, Oslo, Norway.'}, {'ForeName': 'Ingvild Maria', 'Initials': 'IM', 'LastName': 'Tøllefsen', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Ullevål, Oslo, Norway.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Bendz', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Svend', 'Initials': 'S', 'LastName': 'Aakhus', 'Affiliation': ""Clinic of Cardiology, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway; Department of Circulation and Medical Imaging, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.""}, {'ForeName': 'Thor', 'Initials': 'T', 'LastName': 'Ueland', 'Affiliation': 'Research Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway; K. G. Jebsen Thrombosis Research and Expertise Center (TREC), The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Brage Høyem', 'Initials': 'BH', 'LastName': 'Amundsen', 'Affiliation': ""Clinic of Cardiology, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway; Department of Circulation and Medical Imaging, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.""}, {'ForeName': 'Jan Kristian', 'Initials': 'JK', 'LastName': 'Damås', 'Affiliation': 'Department of Infectious Disease, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway; Department of Clinical and Molecular Medicine, Centre of Molecular Inflammation Research, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Erlend Sturle', 'Initials': 'ES', 'LastName': 'Berg', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Bjørkelund', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Bendz', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Einar', 'Initials': 'E', 'LastName': 'Hopp', 'Affiliation': 'Division of Radiology and Nuclear Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Kleveland', 'Affiliation': ""Clinic of Cardiology, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway; Department of Circulation and Medical Imaging, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.""}, {'ForeName': 'Knut Haakon', 'Initials': 'KH', 'LastName': 'Stensæth', 'Affiliation': 'Department of Circulation and Medical Imaging, Norwegian University of Science and Technology (NTNU), Trondheim, Norway; Department of Radiology and Nuclear Medicine, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Opdahl', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Nils-Einar', 'Initials': 'NE', 'LastName': 'Kløw', 'Affiliation': 'Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Department of Radiology, Oslo University Hospital Ullevaal, Oslo, Norway.'}, {'ForeName': 'Ingebjørg', 'Initials': 'I', 'LastName': 'Seljeflot', 'Affiliation': 'Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Department of Cardiology, Oslo University Hospital Ullevål, Oslo, Norway; Department of Cardiology, Center for Clinical Heart Research, Oslo University Hospital Ullevaal, Oslo, Norway.'}, {'ForeName': 'Geir Øystein', 'Initials': 'GØ', 'LastName': 'Andersen', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Ullevål, Oslo, Norway; Department of Cardiology, Center for Clinical Heart Research, Oslo University Hospital Ullevaal, Oslo, Norway.'}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Wiseth', 'Affiliation': ""Clinic of Cardiology, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway; Department of Circulation and Medical Imaging, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.""}, {'ForeName': 'Pål', 'Initials': 'P', 'LastName': 'Aukrust', 'Affiliation': 'Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Department of Rheumatology, Dermatology and Infectious Disease, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Gullestad', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway; K. G. Jebsen Cardiac Research Centre and Centre for Heart Failure Research, University of Oslo, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2021.02.049'] 3922,33858527,Efficacy of an integrative approach for bipolar disorder: preliminary results from a randomized controlled trial.,"BACKGROUND Bipolar disorder (BD) represents one of the most therapeutically complex psychiatric disorders. The development of a feasible comprehensive psychological approach to complement pharmacotherapy to improve its clinical management is required. The main objective of the present randomized controlled trial (RCT) was to test the efficacy of a novel adjunctive treatment entitled integrative approach in patients with BD, including: psychoeducation, mindfulness training, and functional remediation. METHODS This is a parallel two-armed, rater-blind RCT of an integrative approach plus treatment as usual (TAU), v. TAU alone. Participants were recruited at the Hospital Clinic of Barcelona and randomized to one of the two conditions. They were assessed at baseline and after finishing the intervention. The main outcome variable included changes in psychosocial functioning assessed through the Functioning Assessment Short Test (FAST). RESULTS After finishing the treatment, the repeated-measures analyses revealed a significant group × time interaction in favor of the patients who received the integrative approach (n = 28) compared to the TAU group (n = 37) (Pillai's trace = 0.10; F(1,57) = 6.9; p = 0.01), improving the functional outcome. Significant effects were also found in two out of the six domains of the FAST, including the cognitive domain (Pillai's trace = 0.25; F(1,57) = 19.1; p < 0.001) and leisure time (Pillai's trace = 0.11; F(1,57) = 7.15; p = 0.01). Regarding the secondary outcomes, a significant group × time interaction in Hamilton Depression Rating Scale changes was detected (Pillai's trace = 0.08; F(1,62) = 5.6; p = 0.02). CONCLUSION This preliminary study suggests that the integrative approach represents a promising cost-effective therapy to improve psychosocial functioning and residual depressive symptoms in patients suffering from BD.",2021,"After finishing the treatment, the repeated-measures analyses revealed a significant group × time interaction in favor of the patients who received the integrative approach (n = 28) compared to the TAU group (n = 37) (Pillai's trace = 0.10; F(1,57) = 6.9; p = 0.01), improving the functional outcome.","['bipolar disorder', 'Participants were recruited at the Hospital Clinic of Barcelona and randomized to one of the two conditions', 'patients with BD, including', 'patients suffering from BD']","['psychoeducation, mindfulness training, and functional remediation', 'integrative approach']","['psychosocial functioning and residual depressive symptoms', 'functional outcome', 'time interaction', 'leisure time', 'time interaction in Hamilton Depression Rating Scale changes', 'psychosocial functioning assessed through the Functioning Assessment Short Test (FAST']","[{'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0587906', 'cui_str': 'Hospital clinic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",37.0,0.187624,"After finishing the treatment, the repeated-measures analyses revealed a significant group × time interaction in favor of the patients who received the integrative approach (n = 28) compared to the TAU group (n = 37) (Pillai's trace = 0.10; F(1,57) = 6.9; p = 0.01), improving the functional outcome.","[{'ForeName': 'Èlia', 'Initials': 'È', 'LastName': 'Valls', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'C Mar', 'Initials': 'CM', 'LastName': 'Bonnín', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'Imma', 'Initials': 'I', 'LastName': 'Torres', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'Mercè', 'Initials': 'M', 'LastName': 'Brat', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Prime-Tous', 'Affiliation': 'Department of Psychiatry and Psychology, Institute of Neurosciences, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'Ivette', 'Initials': 'I', 'LastName': 'Morilla', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Segú', 'Affiliation': 'Department of Psychiatry and Psychology, Institute of Neurosciences, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'Brisa', 'Initials': 'B', 'LastName': 'Solé', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Torrent', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Vieta', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'Anabel', 'Initials': 'A', 'LastName': 'Martínez-Arán', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Reinares', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Sánchez-Moreno', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}]",Psychological medicine,['10.1017/S0033291721001057'] 3923,33858516,Correction to: Optimising medication management in children and young people with ADHD using a computerised test (QbTest): a feasibility randomised controlled trial.,,2021,,['children and young people with ADHD'],[],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}]",[],[],,0.105731,,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Williams', 'Affiliation': 'School of Medicine, Division of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK. laura.williams1@nottingham.ac.uk.'}, {'ForeName': 'Charlotte L', 'Initials': 'CL', 'LastName': 'Hall', 'Affiliation': 'School of Medicine, Division of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Brown', 'Affiliation': 'School of Medicine, Division of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK.'}, {'ForeName': 'Boliang', 'Initials': 'B', 'LastName': 'Guo', 'Affiliation': 'School of Medicine, Division of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'James', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Matilde', 'Initials': 'M', 'LastName': 'Franceschini', 'Affiliation': 'Division of Rehabilitation and Ageing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Clarke', 'Affiliation': 'United Lincolnshire Hospitals NHS Trust, Grantham and District Hospital, Grantham, Lincolnshire, UK.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Selby', 'Affiliation': 'Department of Community Paediatrics, Medway NHS Foundation Trust, Kent, UK.'}, {'ForeName': 'Hena', 'Initials': 'H', 'LastName': 'Vijayan', 'Affiliation': 'North East London NHS Foundation Trust, Havering CAMHS, Essex, UK.'}, {'ForeName': 'Neeta', 'Initials': 'N', 'LastName': 'Kulkarni', 'Affiliation': 'Leicestershire Partnership NHS Trust, Leicester, UK.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Brown', 'Affiliation': 'School of Medicine, Division of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK.'}, {'ForeName': 'Kapil', 'Initials': 'K', 'LastName': 'Sayal', 'Affiliation': 'School of Medicine, Division of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Hollis', 'Affiliation': 'School of Medicine, Division of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK.'}, {'ForeName': 'Madeleine J', 'Initials': 'MJ', 'LastName': 'Groom', 'Affiliation': 'School of Medicine, Division of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK.'}]",Pilot and feasibility studies,['10.1186/s40814-021-00830-2'] 3924,33858504,"A randomized, controlled clinical trial of autologous stromal vascular fraction cells transplantation to promote mechanical stretch-induced skin regeneration.","BACKGROUND The regeneration response of the skin to mechanical stretching in vivo has been explored in reconstructive surgery to repair large-scale deformities. The ability of the skin to regenerate limits the reconstructive outcome. Here, we propose an approach in which autologous stromal vascular fraction (SVF) cells and mechanical stretching are combined to overcome this limitation and promote skin regeneration. METHODS This randomized, blinded, placebo-controlled clinical trial screened 22 participants undergoing tissue expansion with exhausted regeneration. Twenty eligible participants received intradermal injections of the SVF or placebo treatments. Follow-ups were conducted at 4, 8, and 12 weeks to assess efficacy and at 2 years to assess safety. The primary endpoint was the expanded skin thickness at 12 weeks. The secondary endpoints included skin thickness at 4 and 8 weeks, the expansion index (EI), and the skin texture score at 12 weeks. RESULTS The skin thickness of the SVF group was significantly higher than that of the control group at both 8 weeks (mean difference 0.78 [95% CI - 1.43 to - 0.11]; p = 0.018) and 12 weeks (0.65 [95% CI - 1.30 to - 0.01]; p = 0.046). In the SVF group, the increase in skin thickness was significant at 4 weeks (0.49 [95% CI - 0.80 to - 0.06]; p = 0.010) to 8 weeks (0.45 [95% CI - 0.92 to 0.02]; p = 0.026) and maintained after 12 weeks, whereas that in the control group was reduced after 8 weeks (0.42 [95% CI - 0.07 to 0.91]; p = 0.037). The SVF group showed greater EI increases than the control group (0.50 [95% CI - 0.00 to 0.99]; p = 0.047). The skin texture scores in the SVF group were greater than those in the control group at 12 weeks. Histologically, SVF-treated expanded skin showed more proliferating cells and blood vessels, and the extracellular matrix volume increased. No severe adverse events occurred. CONCLUSIONS Transplantation of SVF cells can expedite the potency of mechanical stretch-induced skin regeneration and provide clinical reconstruction with plentiful tissue. TRIAL REGISTRATION This trial was registered with the Chinese Clinical Trial Registry, ChiCTR2000039317 (registered 23 October 2020-retrospectively registered).",2021,The SVF group showed greater EI increases than the control group (0.50 [95% CI - 0.00 to 0.99]; p = 0.047).,"['22 participants undergoing tissue expansion with exhausted regeneration', 'Twenty eligible participants received']","['autologous stromal vascular fraction cells transplantation', 'placebo', 'intradermal injections of the SVF or placebo']","['skin thickness at 4 and 8\u2009weeks, the expansion index (EI), and the skin texture score', 'proliferating cells and blood vessels', 'expanded skin thickness', 'skin thickness', 'skin texture scores', 'severe adverse events']","[{'cui': 'C0040290', 'cui_str': 'Tissue Expansion'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0034963', 'cui_str': 'Regeneration'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0206153', 'cui_str': 'Transplantation, Cell'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021489', 'cui_str': 'Intradermal injection'}]","[{'cui': 'C0423756', 'cui_str': 'Thickness of skin'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0423752', 'cui_str': 'Finding of skin texture'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}]",22.0,0.349061,The SVF group showed greater EI increases than the control group (0.50 [95% CI - 0.00 to 0.99]; p = 0.047).,"[{'ForeName': 'Poh-Ching', 'Initials': 'PC', 'LastName': 'Tan', 'Affiliation': ""Department of Plastic & Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, 639 Zhizhaoju Road, Shanghai, 200011, People's Republic of China.""}, {'ForeName': 'Pei-Chuan', 'Initials': 'PC', 'LastName': 'Chao', 'Affiliation': ""Department of Plastic & Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, 639 Zhizhaoju Road, Shanghai, 200011, People's Republic of China.""}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Cheng', 'Affiliation': ""Department of Plastic & Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, 639 Zhizhaoju Road, Shanghai, 200011, People's Republic of China.""}, {'ForeName': 'Chu-Hsin', 'Initials': 'CH', 'LastName': 'Chen', 'Affiliation': ""Department of Plastic & Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, 639 Zhizhaoju Road, Shanghai, 200011, People's Republic of China.""}, {'ForeName': 'Ru-Lin', 'Initials': 'RL', 'LastName': 'Huang', 'Affiliation': ""Department of Plastic & Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, 639 Zhizhaoju Road, Shanghai, 200011, People's Republic of China.""}, {'ForeName': 'Shuang-Bai', 'Initials': 'SB', 'LastName': 'Zhou', 'Affiliation': ""Department of Plastic & Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, 639 Zhizhaoju Road, Shanghai, 200011, People's Republic of China. shuangbaizhou@yahoo.com.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': ""Department of Plastic & Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, 639 Zhizhaoju Road, Shanghai, 200011, People's Republic of China. amiyayun@qq.com.""}, {'ForeName': 'Qing-Feng', 'Initials': 'QF', 'LastName': 'Li', 'Affiliation': ""Department of Plastic & Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, 639 Zhizhaoju Road, Shanghai, 200011, People's Republic of China. dr.liqingfeng@yahoo.com.""}]",Stem cell research & therapy,['10.1186/s13287-021-02318-5'] 3925,33858493,Stereotactic cisternal lavage in patients with aneurysmal subarachnoid hemorrhage with urokinase and nimodipine for the prevention of secondary brain injury (SPLASH): study protocol for a randomized controlled trial.,"BACKGROUND Delayed cerebral infarction (DCI) is a major cause of death and poor neurological outcome in patients with aneurysmal subarachnoid hemorrhage (aSAH). Direct intrathecal therapies with fibrinolytic and spasmolytic drugs have appeared promising in clinical trials. However, access to the subarachnoid space for intrathecal drug administration is an unsolved problem so far, especially in patients with endovascular aneurysm securing. We investigate a therapy protocol based on stereotactic catheter ventriculocisternostomy (STX-VCS), a new approach to overcome this problem. The primary objective of this study is to assess whether cisternal lavage with urokinase, nimodipine, and Ringer's solution administered via a stereotactically implanted catheter into the basal cisterns (= investigational treatment (IT)) is safe and improves neurological outcome in patients with aSAH. METHODS This is a randomized, controlled, parallel-group, open-label phase II trial. Fifty-four patients with severe aSAH (WFNS grade ≥ 3) will be enrolled at one academic tertiary care center in Southern Germany. Patients will be randomized at a ratio of 1:1 to receive either standard of care only or standard of care plus the IT. The primary endpoint is the proportion of subjects with a favorable outcome on the Modified Rankin Scale (defined as mRS 0-3) at 6 months after aSAH. Further clinical and surrogate outcome parameters are defined as secondary endpoints. DISCUSSION New approaches for the prevention and therapy of secondary brain injury in patients with aSAH are urgently needed. We propose this RCT to assess the clinical safety and efficacy of a novel therapy protocol for intrathecal administration of urokinase, nimodipine, and Ringer's solution. TRIAL REGISTRATION Deutsches Register Klinischer Studien (German Clinical Trials Register), DRKS00015645 . Registered on 8 May 2019.",2021,"We propose this RCT to assess the clinical safety and efficacy of a novel therapy protocol for intrathecal administration of urokinase, nimodipine, and Ringer's solution. ","['patients with aneurysmal subarachnoid hemorrhage with', 'Fifty-four patients with severe aSAH (WFNS grade\u2009≥\u20093) will be enrolled at one academic tertiary care center in Southern Germany', 'patients with aSAH', 'patients with endovascular aneurysm securing', 'patients with aneurysmal subarachnoid hemorrhage (aSAH']","['Stereotactic cisternal lavage', 'stereotactic catheter ventriculocisternostomy (STX-VCS', 'standard of care only or standard of care plus the IT', 'urokinase and nimodipine', ""urokinase, nimodipine, and Ringer's solution""]","['clinical safety and efficacy', 'proportion of subjects with a favorable outcome on the Modified Rankin Scale', 'neurological outcome']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751530', 'cui_str': 'Subarachnoid Hemorrhage, Aneurysmal'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}]","[{'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0042515', 'cui_str': 'Ventriculocisternostomy'}, {'cui': 'C0036248', 'cui_str': 'Saxitoxin'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0042071', 'cui_str': 'Urokinase'}, {'cui': 'C0028094', 'cui_str': 'Nimodipine'}, {'cui': 'C0073386', 'cui_str': 'Ringers Solution'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}]",54.0,0.245066,"We propose this RCT to assess the clinical safety and efficacy of a novel therapy protocol for intrathecal administration of urokinase, nimodipine, and Ringer's solution. ","[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Roelz', 'Affiliation': 'Department of Neurosurgery, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Schubach', 'Affiliation': 'Clinical Trials Unit, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg im Breisgau, Germany. fabian.schubach@uniklinik-freiburg.de.'}, {'ForeName': 'Volker A', 'Initials': 'VA', 'LastName': 'Coenen', 'Affiliation': 'Department of Stereotactic and Functional Neurosurgery, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Jenkner', 'Affiliation': 'Clinical Trials Unit, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Scheiwe', 'Affiliation': 'Department of Neurosurgery, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Grauvogel', 'Affiliation': 'Department of Neurosurgery, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Wolf-Dirk', 'Initials': 'WD', 'LastName': 'Niesen', 'Affiliation': 'Department of Neurology and Neurophysiology, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Horst', 'Initials': 'H', 'LastName': 'Urbach', 'Affiliation': 'Department of Neuroradiology, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Taschner', 'Affiliation': 'Department of Neuroradiology, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Seufert', 'Affiliation': 'Department of Medicine II, Division of Endocrinology and Diabetology, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Kätzler', 'Affiliation': 'Department of Internal Medicine III, Clinical Trials Office, University Medical Center Ulm, Ulm, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Beck', 'Affiliation': 'Department of Neurosurgery, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Reinacher', 'Affiliation': 'Department of Stereotactic and Functional Neurosurgery, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg im Breisgau, Germany.'}]",Trials,['10.1186/s13063-021-05208-6'] 3926,33858488,A prospective multicenter assessor-blinded randomized controlled study to compare the efficacy of short versus long protocols of electroconvulsive therapy as an augmentation strategy to clozapine in patients with ultra-resistant schizophrenia (SURECT study).,"BACKGROUND Although clozapine is the most effective antipsychotic drug for treatment-resistant schizophrenia, it leads to a poor or partial response in 40 to 70% of patients. Augmentation of clozapine with electroconvulsive therapy (ECT) is a highly effective and relatively safe treatment for these clozapine-resistant patients. However, parameters are not yet well specified, such as the optimal number of sessions, their frequency, and the relevance of maintenance ECT. Our objective is to compare the efficacy and tolerance between two protocols of combined ECT and clozapine treatment in patients with ultra-resistant schizophrenia (URS): a 6-month protocol (short protocol with 20 ECT sessions) and a 12-month protocol (long protocol with 40 ECT sessions). METHODS Sixty-four patients with schizophrenia with persistent psychotic symptoms despite clozapine treatment will be enrolled in a prospective multicentric assessor-blinded randomized controlled trial. Patients will be randomly assigned to the short or the long protocol. The main outcome is the response rate assessed by the Positive and Negative Symptoms Scale (PANSS) 3 months after the end of the treatment in patients following the long protocol compared to those following the short protocol. The response was defined as a 30% reduction on the PANSS baseline. Clinical assessments (PANSS, BPRS, HAMD-21, YMRS, CGI, GAF, Modified Overt Aggression Scale (MOAS), and Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS)) and plasma clozapine concentration will be performed at baseline and at 2, 4, 6, 9, 12, and 15 months. Neuropsychological measures (MMSE, RL/RI-16, Doors test, D2 Test of Attention, Copy of the Rey-Osterrieth complex figure) will be performed at baseline and at 6 and 15 months. DISCUSSION The aims of this research are to optimize protocols of combined ECT with clozapine in patients with URS and to offer specific recommendations for these patients' care. TRIAL REGISTRATION ClinicalTrials.gov NCT03542903 . Registered on May 31, 2018. Id RCB: 2017-A02657-46.",2021,The main outcome is the response rate assessed by the Positive and Negative Symptoms Scale (PANSS) 3 months after the end of the treatment in patients following the long protocol compared to those following the short protocol.,"['Sixty-four patients with schizophrenia with persistent psychotic symptoms despite', 'patients with URS', 'patients with ultra-resistant schizophrenia (SURECT study', 'patients with ultra-resistant schizophrenia (URS']","['clozapine treatment', 'ECT and clozapine', 'clozapine', 'clozapine with electroconvulsive therapy (ECT', 'electroconvulsive therapy']","['efficacy and tolerance', 'Neuropsychological measures (MMSE, RL/RI-16, Doors test, D2 Test of Attention, Copy of the Rey-Osterrieth complex figure', 'response rate assessed by the Positive and Negative Symptoms Scale (PANSS', 'Clinical assessments (PANSS, BPRS, HAMD-21, YMRS, CGI, GAF, Modified Overt Aggression Scale (MOAS), and Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS)) and plasma clozapine concentration']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0009079', 'cui_str': 'Clozapine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0557698', 'cui_str': 'Door'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C4505408', 'cui_str': 'Rey-Osterrieth Complex Figure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3640523', 'cui_str': 'YMRS'}, {'cui': 'C1565805', 'cui_str': 'FGF9 protein, human'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0009079', 'cui_str': 'Clozapine'}]",64.0,0.109305,The main outcome is the response rate assessed by the Positive and Negative Symptoms Scale (PANSS) 3 months after the end of the treatment in patients following the long protocol compared to those following the short protocol.,"[{'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Moulier', 'Affiliation': ""University Department of Psychiatry, Centre d'Excellence Thérapeutique- Institut de Psychiatrie, Centre Hospitalier du Rouvray, Sotteville-lès-Rouen, France. virginie.moulier@ch-lerouvray.fr.""}, {'ForeName': 'Mohamed Wassim', 'Initials': 'MW', 'LastName': 'Krir', 'Affiliation': ""University Department of Psychiatry, Centre d'Excellence Thérapeutique- Institut de Psychiatrie, Centre Hospitalier du Rouvray, Sotteville-lès-Rouen, France.""}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Dalmont', 'Affiliation': ""University Department of Psychiatry, Centre d'Excellence Thérapeutique- Institut de Psychiatrie, Centre Hospitalier du Rouvray, Sotteville-lès-Rouen, France.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Guillin', 'Affiliation': ""University Department of Psychiatry, Centre d'Excellence Thérapeutique- Institut de Psychiatrie, Centre Hospitalier du Rouvray, Sotteville-lès-Rouen, France. olivier.guillin@ch-lerouvray.fr.""}, {'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Rothärmel', 'Affiliation': ""University Department of Psychiatry, Centre d'Excellence Thérapeutique- Institut de Psychiatrie, Centre Hospitalier du Rouvray, Sotteville-lès-Rouen, France.""}]",Trials,['10.1186/s13063-021-05227-3'] 3927,33858486,"Clinical, microbiological, and immunological effects of systemic probiotics in periodontal treatment: study protocol for a randomized controlled trial.","BACKGROUND The association of scaling and root planing (SRP) with systemic metronidazole (MTZ) plus amoxicillin (AMX) has shown to be an effective treatment protocol, particularly for periodontitis stages III and IV, generalized. More recently, probiotics have also been suggested as a promising adjunctive treatment for periodontal diseases due to their antimicrobial and anti-inflammatory properties. Therefore, the aim of this randomized clinical trial (RCT) is to evaluate the clinical, microbiological, and immunological effects of probiotics as adjuncts to SRP alone or with MTZ+AMX in the treatment of periodontitis. METHODS Subjects with periodontitis are being randomly assigned to receive (i) SRP alone, or with (ii) two probiotic lozenges/day for 90 days (Prob), (iii) MTZ (400 mg) and AMX (500 mg) thrice a day (TID) for 14 days (MTZ+AMX), or (iv) Prob and MTZ+AMX. Subjects are being monitored for up to 12 months post-treatment. Nine subgingival plaque samples per patient are being collected at baseline and at 3, 6, and 12 months post-therapy and analyzed by checkerboard DNA-DNA hybridization for 40 bacterial species. Peripheral blood and gingival crevicular fluid (GCF) of four randomly selected periodontal sites will be analyzed by means of a multiplex fluorescent bead-based immunoassay for 17 cyto/chemokines. STATISTICAL ANALYSES The significance of differences in each group (over the course of the study) will be sought using repeated measures ANOVA or Friedman tests and among groups (at each time point) using either ANOVA/ANCOVA or Kruskal-Wallis tests, depending on normality of the data. The chi-square test will be used to compare differences in the frequency of subjects achieving the clinical endpoint for treatment (≤ 4 sites with PD ≥ 5 mm) at 1 year and of self-perceived adverse effects. A stepwise forward logistic regression analysis will be performed in order to investigate the impact of different predictor variables on the percentage of patients achieving the clinical endpoint for treatment. The Number Needed to Treat (NNT) with different treatment protocols will be also calculated. Statistical significance will be set at 5%. TRIAL REGISTRATION ClinicalTrials.gov NCT03733379. Registered on November 7, 2018.",2021,The chi-square test will be used to compare differences in the frequency of subjects achieving the clinical endpoint for treatment (≤ 4 sites with PD ≥ 5 mm) at 1 year and of self-perceived adverse effects.,['Subjects with periodontitis'],"['AMX (500\u2009mg) thrice a day (TID) for 14\u2009days (MTZ+AMX), or (iv) Prob and MTZ+AMX', 'MTZ+AMX', 'systemic metronidazole (MTZ) plus amoxicillin (AMX', 'SRP alone, or with (ii) two probiotic lozenges/day for 90\u2009days (Prob), (iii) MTZ']",['Peripheral blood and gingival crevicular fluid (GCF'],"[{'cui': 'C0031099', 'cui_str': 'Periodontitis'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}]",4.0,0.10284,The chi-square test will be used to compare differences in the frequency of subjects achieving the clinical endpoint for treatment (≤ 4 sites with PD ≥ 5 mm) at 1 year and of self-perceived adverse effects.,"[{'ForeName': 'Belen', 'Initials': 'B', 'LastName': 'Retamal-Valdes', 'Affiliation': 'Department of Periodontology, Dental Research Division, Centro de Pós-Graduação e Pesquisa-CEPPE, Guarulhos University, Praça Tereza Cristina, 229 Centro, Guarulhos, SP, 07023-070, Brazil.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Teughels', 'Affiliation': 'Department of Oral Health Sciences, Periodontology, Katholieke Universiteit Leuven (KULeuven), Leuven, Belgium.'}, {'ForeName': 'Laryssa Macedo', 'Initials': 'LM', 'LastName': 'Oliveira', 'Affiliation': 'Department of Periodontology, Dental Research Division, Centro de Pós-Graduação e Pesquisa-CEPPE, Guarulhos University, Praça Tereza Cristina, 229 Centro, Guarulhos, SP, 07023-070, Brazil.'}, {'ForeName': 'Rebeca Nascimento', 'Initials': 'RN', 'LastName': 'da Silva', 'Affiliation': 'Department of Periodontology, Dental Research Division, Centro de Pós-Graduação e Pesquisa-CEPPE, Guarulhos University, Praça Tereza Cristina, 229 Centro, Guarulhos, SP, 07023-070, Brazil.'}, {'ForeName': 'Aretuza', 'Initials': 'A', 'LastName': 'Fritoli', 'Affiliation': 'Department of Periodontology, Dental Research Division, Centro de Pós-Graduação e Pesquisa-CEPPE, Guarulhos University, Praça Tereza Cristina, 229 Centro, Guarulhos, SP, 07023-070, Brazil.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Gomes', 'Affiliation': 'Department of Periodontology, Dental Research Division, Centro de Pós-Graduação e Pesquisa-CEPPE, Guarulhos University, Praça Tereza Cristina, 229 Centro, Guarulhos, SP, 07023-070, Brazil.'}, {'ForeName': 'Geisla Mary Silva', 'Initials': 'GMS', 'LastName': 'Soares', 'Affiliation': 'Department of Stomatology, Federal University of Parana, Curitiba, Parana, Brazil.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Temporão', 'Affiliation': 'Department of Stomatology, Federal University of Parana, Curitiba, Parana, Brazil.'}, {'ForeName': 'Camila Pinheiro', 'Initials': 'CP', 'LastName': 'Furquim', 'Affiliation': 'Department of Periodontology, Dental Research Division, Centro de Pós-Graduação e Pesquisa-CEPPE, Guarulhos University, Praça Tereza Cristina, 229 Centro, Guarulhos, SP, 07023-070, Brazil.'}, {'ForeName': 'Poliana Mendes', 'Initials': 'PM', 'LastName': 'Duarte', 'Affiliation': 'Department of Periodontology, Dental Research Division, Centro de Pós-Graduação e Pesquisa-CEPPE, Guarulhos University, Praça Tereza Cristina, 229 Centro, Guarulhos, SP, 07023-070, Brazil.'}, {'ForeName': 'Helio', 'Initials': 'H', 'LastName': 'Doyle', 'Affiliation': 'Department of Periodontology, Dental Research Division, Centro de Pós-Graduação e Pesquisa-CEPPE, Guarulhos University, Praça Tereza Cristina, 229 Centro, Guarulhos, SP, 07023-070, Brazil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Faveri', 'Affiliation': 'Department of Periodontology, Dental Research Division, Centro de Pós-Graduação e Pesquisa-CEPPE, Guarulhos University, Praça Tereza Cristina, 229 Centro, Guarulhos, SP, 07023-070, Brazil.'}, {'ForeName': 'Luciene Cristina', 'Initials': 'LC', 'LastName': 'Figueiredo', 'Affiliation': 'Department of Periodontology, Dental Research Division, Centro de Pós-Graduação e Pesquisa-CEPPE, Guarulhos University, Praça Tereza Cristina, 229 Centro, Guarulhos, SP, 07023-070, Brazil. lucienedefigueiredo@gmail.com.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Feres', 'Affiliation': 'Department of Periodontology, Dental Research Division, Centro de Pós-Graduação e Pesquisa-CEPPE, Guarulhos University, Praça Tereza Cristina, 229 Centro, Guarulhos, SP, 07023-070, Brazil.'}]",Trials,['10.1186/s13063-021-05246-0'] 3928,33858462,"""Our Choice"" improves use of safer conception methods among HIV serodiscordant couples in Uganda: a cluster randomized controlled trial evaluating two implementation approaches.","BACKGROUND Safer conception counseling (SCC) to promote the use of safer conception methods (SCM) is not yet part of routine family planning or HIV care. Guidelines for the use of SCM have been published, but to date there are no published controlled evaluations of SCC. Furthermore, it is unknown whether standard methods commonly used in resource constrained settings to integrate new services would be sufficient, or if enhanced training and supervision would result in a more efficacious approach to implementing SCC. METHODS In a hybrid, cluster randomized controlled trial, six HIV clinics were randomly assigned to implement the SCC intervention Our Choice using either a high (SCC1) or low intensity (SCC2) approach (differentiated by amount of training and supervision), or existing family planning services (usual care). Three hundred eighty-nine HIV clients considering childbearing with an HIV-negative partner enrolled. The primary outcome was self-reported use of appropriate reproductive method (SCM if trying to conceive; modern contraceptives if not) over 12 months or until pregnancy. RESULTS The combined intervention groups used appropriate reproductive methods more than usual care [20.8% vs. 6.9%; adjusted OR (95% CI)=10.63 (2.79, 40.49)], and SCC1 reported a higher rate than SCC2 [27.1% vs. 14.6%; OR (95% CI)=4.50 (1.44, 14.01)]. Among those trying to conceive, the intervention arms reported greater accurate use of SCM compared to usual care [24.1% vs. 0%; OR (95% CI)=91.84 (4.94, 1709.0)], and SCC1 performed better than SCC2 [34.6% vs. 11.5%; OR (95% CI)=6.43 (1.90, 21.73)]. The arms did not vary on modern contraception use among those not trying to conceive. A cost of $631 per person was estimated to obtain accurate use of SCM in SCC1, compared to $1014 in SCC2. CONCLUSIONS More intensive provider training and more frequent supervision leads to greater adoption of complex SCM behaviors and is more cost-effective than the standard low intensity implementation approach. TRIAL REGISTRATION Clinicaltrials.gov, NCT03167879 ; date registered May 23, 2017.",2021,"Among those trying to conceive, the intervention arms reported greater accurate use of SCM compared to usual care [24.1% vs. 0%; OR (95% CI)=91.84 (4.94, 1709.0)], and SCC1 performed better than SCC2 [34.6% vs. 11.5%; OR (95% CI)=6.43 (1.90, 21.73)].","['HIV serodiscordant couples in Uganda', 'six HIV clinics', 'Three hundred eighty-nine HIV clients considering childbearing with an HIV-negative partner enrolled']","['SCM', 'SCC intervention Our Choice using either a high (SCC1) or low intensity (SCC2) approach (differentiated by amount of training and supervision), or existing family planning services (usual care', 'Safer conception counseling (SCC']",['self-reported use of appropriate reproductive method (SCM if trying to conceive'],"[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}]","[{'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009861', 'cui_str': 'Family planning service'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0420843', 'cui_str': 'Trying to conceive'}]",6.0,0.0781822,"Among those trying to conceive, the intervention arms reported greater accurate use of SCM compared to usual care [24.1% vs. 0%; OR (95% CI)=91.84 (4.94, 1709.0)], and SCC1 performed better than SCC2 [34.6% vs. 11.5%; OR (95% CI)=6.43 (1.90, 21.73)].","[{'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Wagner', 'Affiliation': 'RAND Corporation, 1776 Main St., Santa Monica, CA, 91105, USA. gwagner@rand.org.'}, {'ForeName': 'Rhoda K', 'Initials': 'RK', 'LastName': 'Wanyenze', 'Affiliation': 'School of Public Health, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Jolly', 'Initials': 'J', 'LastName': 'Beyeza-Kashesya', 'Affiliation': 'Department of Reproductive Medicine, Mulago Specialised Women and Neonatal Hospital, Kampala, Uganda.'}, {'ForeName': 'Violet', 'Initials': 'V', 'LastName': 'Gwokyalya', 'Affiliation': 'Department of Disease Control and Environmental Health, Makerere University School of Public Health, Kampala, Uganda.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Hurley', 'Affiliation': ""Children's Mercy Research Institute, Children's Mercy Kansas City, University of Missouri - Kansas City School of Medicine, 2401 Gillham Road, Kansas City, MO, 64108, USA.""}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Mindry', 'Affiliation': ""University of California Global Health Institute, Center for Women's Health and Empowerment, 1234 Sunny Oaks Circle, Altadena, CA, 91001, USA.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Finocchario-Kessler', 'Affiliation': 'Department of Family Medicine & Community Health, University of Kansas Medical Center, Kansas City, KS, 66160, USA.'}, {'ForeName': 'Mastula', 'Initials': 'M', 'LastName': 'Nanfuka', 'Affiliation': 'The AIDS Support Organization, Kampala, Uganda.'}, {'ForeName': 'Mahlet G', 'Initials': 'MG', 'LastName': 'Tebeka', 'Affiliation': 'Pardee RAND Graduate School, 1776 Main St., Santa Monica, CA, 91105, USA.'}, {'ForeName': 'Uzaib', 'Initials': 'U', 'LastName': 'Saya', 'Affiliation': 'Pardee RAND Graduate School, 1776 Main St., Santa Monica, CA, 91105, USA.'}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Booth', 'Affiliation': 'RAND Corporation, 1776 Main St., Santa Monica, CA, 91105, USA.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Ghosh-Dastidar', 'Affiliation': 'RAND Corporation, 1776 Main St., Santa Monica, CA, 91105, USA.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Linnemayr', 'Affiliation': 'RAND Corporation, 1776 Main St., Santa Monica, CA, 91105, USA.'}, {'ForeName': 'Vincent S', 'Initials': 'VS', 'LastName': 'Staggs', 'Affiliation': ""Children's Mercy Research Institute, Children's Mercy Kansas City, University of Missouri - Kansas City School of Medicine, 2401 Gillham Road, Kansas City, MO, 64108, USA.""}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Goggin', 'Affiliation': ""Children's Mercy Research Institute, Children's Mercy Kansas City, University of Missouri - Kansas City School of Medicine, 2401 Gillham Road, Kansas City, MO, 64108, USA.""}]",Implementation science : IS,['10.1186/s13012-021-01109-z'] 3929,33858441,"Sulfur amino acid restriction, energy metabolism and obesity: a study protocol of an 8-week randomized controlled dietary intervention with whole foods and amino acid supplements.","BACKGROUND Dietary sulfur amino acid (SAA) restriction is an established animal model for increasing lifespan and improving metabolic health. Data from human studies are limited. In the study outlined in this protocol, we will evaluate if dietary SAA restriction can reduce body weight and improve resting energy expenditure (REE) and parameters related to metabolic health. METHOD/DESIGN Men and women (calculated sample size = 60), aged 18-45 years, with body mass index of 27-35 kg/m 2 will be included in a double-blind 8-week dietary intervention study. The participants will be randomized in a 1:1 manner to a diet with either low or high SAA. Both groups will receive an equal base diet consisting of low-SAA plant-based whole foods and an amino acid supplement free of SAA. Contrasting SAA contents will be achieved using capsules with or without methionine and cysteine (SAA high , total diet SAA ~ 50-60 mg/kg body weight/day; SAA low , total diet SAA ~ 15-25 mg/kg body weight/day). The primary outcome is body weight change. Data and material collection will also include body composition (dual X-ray absorptiometry), resting energy expenditure (whole-room indirect calorimetry) and samples of blood, urine, feces and adipose tissue at baseline, at 4 weeks and at study completion. Measures will be taken to promote and monitor diet adherence. Data will be analyzed using linear mixed model regression to account for the repeated measures design and within-subject correlation. DISCUSSION The strength of this study is the randomized double-blind design. A limitation is the restrictive nature of the diet which may lead to poor compliance. If this study reveals a beneficial effect of the SAA low diet on body composition and metabolic health, it opens up for new strategies for prevention and treatment of overweight, obesity and its associated disorders. Trial registration ClinicalTrials.gov: NCT04701346, Registration date: January 8th, 2021.",2021,"If this study reveals a beneficial effect of the SAA low diet on body composition and metabolic health, it opens up for new strategies for prevention and treatment of overweight, obesity and its associated disorders.","['Men and women (calculated sample size\u2009=\u200960), aged 18-45\xa0years, with body mass index of 27-35\xa0kg/m 2 will be included in a double-blind 8-week dietary intervention study']","['SAA low diet', 'dietary intervention with whole foods and amino acid supplements', 'diet with either low or high SAA', 'Dietary sulfur amino acid (SAA) restriction', 'equal base diet consisting of low-SAA plant-based whole foods and an amino acid supplement free of SAA', 'dietary SAA restriction']","['body weight change', 'body weight and improve resting energy expenditure (REE', 'Sulfur amino acid restriction, energy metabolism and obesity']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0002527', 'cui_str': 'Sulfur-bearing amino acid'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0453870', 'cui_str': 'Whole food'}, {'cui': 'C0556082', 'cui_str': 'Amino acid supplement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]","[{'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0002527', 'cui_str': 'Sulfur-bearing amino acid'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",,0.089915,"If this study reveals a beneficial effect of the SAA low diet on body composition and metabolic health, it opens up for new strategies for prevention and treatment of overweight, obesity and its associated disorders.","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Stolt', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Sognsvannveien 9, 0372, Oslo, Norway.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Olsen', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Sognsvannveien 9, 0372, Oslo, Norway. thomas.olsen@medisin.uio.no.'}, {'ForeName': 'Amany', 'Initials': 'A', 'LastName': 'Elshorbagy', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Sognsvannveien 9, 0372, Oslo, Norway.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Kožich', 'Affiliation': 'Department of Pediatrics and Inherited Metabolic Disorders, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'van Greevenbroek', 'Affiliation': 'Department of Internal Medicine and CARIM School of Cardiovascular Diseases, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Øvrebø', 'Affiliation': 'Department of Sports Science and Physical Education, Faculty of Health and Sport Sciences, University of Agder, Kristiansand, Norway.'}, {'ForeName': 'Magne', 'Initials': 'M', 'LastName': 'Thoresen', 'Affiliation': 'Department of Biostatistics, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Refsum', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Sognsvannveien 9, 0372, Oslo, Norway.'}, {'ForeName': 'Kjetil', 'Initials': 'K', 'LastName': 'Retterstøl', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Sognsvannveien 9, 0372, Oslo, Norway.'}, {'ForeName': 'Kathrine J', 'Initials': 'KJ', 'LastName': 'Vinknes', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Sognsvannveien 9, 0372, Oslo, Norway.'}]",Journal of translational medicine,['10.1186/s12967-021-02824-3'] 3930,33858439,"Mulberry leaf extract improves glycaemic response and insulaemic response to sucrose in healthy subjects: results of a randomized, double blind, placebo-controlled study.","BACKGROUND There are many benefits of maintaining healthy blood glucose levels, and studies have shown that lifestyle changes such as changes to diet can successfully restore normoglycaemia in participants with dysglycaemia. Significant health-related lifestyle changes are often difficult to implement and functional ingredients that can reduce glycaemic and insulaemic responses may help at risk populations. The aim of this study was to investigate whether a mulberry leaf extract could lower the glycaemic and insulinaemic responses to 75 g sucrose in healthy individuals. METHODS A double-blind, randomised, placebo-controlled, crossover design trial was conducted by the Oxford Brookes Centre for Nutrition and Health. Thirty-eight participants were recruited into the trial and, after an overnight fast, were given 75 g sucrose + white mulberry leaf extract, or 75 g sucrose alone. Capillary blood samples were collected at 15-min intervals in the first hour and at 30-min intervals over the second hour to determine glucose and plasma insulin levels. Data analysis was conducted using a paired samples T test or a Wilcoxon signed rank test. RESULTS The addition of mulberry leaf extract to sucrose resulted in a significantly lower glycaemic response and insulinaemic response compared to a matched placebo (sucrose alone). The change in blood glucose measurements were significantly lower at 15 min (p < 0.001), 30 min (p < 0.001), 45 min (p = 0.008), and 120 min (p < 0.001) and plasma insulin measurements were significantly lower at 15 min (p < 0.001), 30 min (p < 0.001), 45 min (p < 0.001), 60 min (p = 0.001) and 120 min (p < 0.001). The glucose iAUC (- 42%, p = 0.001), insulin iAUC (- 40%, p < 0.001), peak glucose (- 40.0%, p < 0.001) and peak insulin (- 41%, p < 0.001) from baseline were significantly lower for white mulberry leaf extract compared with the placebo. White mulberry leaf extract was well tolerated and there were no reported adverse events. CONCLUSIONS Mulberry leaf extract can be used as part of lifestyle changes that may lead to healthy blood glucose levels. TRIAL REGISTRATION ISRCTN99601810 (23 October 2020, retrospectively registered).",2021,"The change in blood glucose measurements were significantly lower at 15 min (p < 0.001), 30 min (p < 0.001), 45 min (p = 0.008), and 120 min (p < 0.001) and plasma insulin measurements were significantly lower at 15 min (p < 0.001), 30 min (p < 0.001), 45 min (","['healthy subjects', 'healthy individuals', 'participants with dysglycaemia', 'Thirty-eight participants']","['placebo', 'sucrose\u2009+\u2009white mulberry leaf extract, or 75\xa0g sucrose alone', 'Mulberry leaf extract', 'mulberry leaf extract']","['glycaemic response and insulaemic response', 'change in blood glucose measurements', 'glucose iAUC', 'peak insulin', 'glycaemic response and insulinaemic response', 'plasma insulin measurements', 'glycaemic and insulinaemic responses', 'peak glucose', 'insulin iAUC', 'Capillary blood samples']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0450361', 'cui_str': '38'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0772361', 'cui_str': 'white mulberry extract'}, {'cui': 'C0242724', 'cui_str': 'Leaves'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0330540', 'cui_str': 'Morus'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1276042', 'cui_str': 'Plasma insulin measurement'}, {'cui': 'C0419342', 'cui_str': 'Capillary specimen collection'}]",38.0,0.274968,"The change in blood glucose measurements were significantly lower at 15 min (p < 0.001), 30 min (p < 0.001), 45 min (p = 0.008), and 120 min (p < 0.001) and plasma insulin measurements were significantly lower at 15 min (p < 0.001), 30 min (p < 0.001), 45 min (","[{'ForeName': 'Pariyarath Sangeetha', 'Initials': 'PS', 'LastName': 'Thondre', 'Affiliation': 'Oxford Brookes Centre for Nutrition and Health, Faculty of Health and Life Sciences, Oxford Brookes University, Gipsy Lane Campus, Headington, Oxford, OX3 0BP, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Lightowler', 'Affiliation': 'Oxford Brookes Centre for Nutrition and Health, Faculty of Health and Life Sciences, Oxford Brookes University, Gipsy Lane Campus, Headington, Oxford, OX3 0BP, UK.'}, {'ForeName': 'Lis', 'Initials': 'L', 'LastName': 'Ahlstrom', 'Affiliation': 'Oxford Brookes Centre for Nutrition and Health, Faculty of Health and Life Sciences, Oxford Brookes University, Gipsy Lane Campus, Headington, Oxford, OX3 0BP, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Gallagher', 'Affiliation': 'Phynova Group Ltd, 16 Fenlock Court, Blenheim Office Park, Long Hanborough, OX29 8LN, UK. agallagher@phynova.com.'}]",Nutrition & metabolism,['10.1186/s12986-021-00571-2'] 3931,33858400,The effect of a supportive home care program on caregiver burden with stroke patients in Iran: an experimental study.,"BACKGROUND Stroke can impose a heavy burden on caregivers. Caring for stroke patients at home is more challenging than in hospitals with facilities. The purpose of this study was to evaluate the effect of a supportive home care program on caregiver burden with stroke patients. METHODS This was an experimental study. One hundred sixteen caregivers of stroke patients were recruited using convenience sampling from two university-affiliated hospitals in Tehran from June 2019 to February 2020. They were randomly allocated into two groups (supportive home care program and routine hospital education program) using a randomized block design. The supportive home care program included eight educational sessions delivered in the hospital before discharge, and with home visits after hospital discharge. Caregiver burden was measured using Caregiver Burden Inventory. The data were analyzed using independent samples t-test and Analysis of Covariance. RESULTS Caregiver burden in the routine education group increased significantly after 2 weeks, from 52.27 ± 23.95 to 62.63 ± 22.68. The mean of caregiver burden scores in the supportive home care program decreased from 44.75 ± 17.21 to 40.46 ± 17.28. The difference between the scores of the two groups before the intervention was not significantly different (t = 1.941, df = 114, p = 0.055). There was a significant difference between the two groups regarding caregiver burden scores after the intervention period (η 2  = 0.305, P < 0.001). CONCLUSIONS Caregiver burden increased significantly after the discharge without proper interventions in the caregivers of stroke patients. Providing support for home care providers can help to decrease or prevent the intensification of caregiver burden.",2021,"The difference between the scores of the two groups before the intervention was not significantly different (t = 1.941, df = 114, p = 0.055).","['One hundred sixteen caregivers of stroke patients were recruited using convenience sampling from two university-affiliated hospitals in Tehran from June 2019 to February 2020', 'caregiver burden with stroke patients in Iran', 'caregiver burden with stroke patients']","['supportive home care program and routine hospital education program', 'supportive home care program']","['caregiver burden scores', 'mean of caregiver burden scores', 'Caregiver burden']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0358675,"The difference between the scores of the two groups before the intervention was not significantly different (t = 1.941, df = 114, p = 0.055).","[{'ForeName': 'Mansoureh', 'Initials': 'M', 'LastName': 'Ashghali Farahani', 'Affiliation': 'Nursing Care Research Center, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Najafi Ghezeljeh', 'Affiliation': 'Nursing Care Research Center, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Haghani', 'Affiliation': 'Nursing Care Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farshid', 'Initials': 'F', 'LastName': 'Alazmani-Noodeh', 'Affiliation': 'Nursing Care Research Center, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran. farshid.gorgani@gmail.com.'}]",BMC health services research,['10.1186/s12913-021-06340-4'] 3932,33858397,Determinants of work capacity (predicted VO 2max ) in non-pregnant women of reproductive age living in rural India.,"BACKGROUND The negative impact of anemia on work capacity has been studied extensively in male and female workers; however, the simultaneous contributions of confounding variables such as physical activity, as well as other behavioral and sociodemographic characteristics have not been considered. The purpose of this study was to examine cross-sectionally the multivariable correlates of work capacity in non-pregnant women (n = 330) living in rural India. METHODS The Reduction in Anemia through Normative Innovations (RANI) Project is a norms-based, clustered randomized controlled trial to reduce anemia among women (15-49 years) living in Odisha, India between 2018 and 2021. For the larger trial, 89 clusters of villages were randomized into treatment and control groups on a 1:1 basis. Women (2055/group) living in 15 selected clusters (40-41 villages) were then randomly selected for data collection. The sampling design also randomly-generated a subset (n = 375) of non-pregnant participants who performed a modified Queen's College Step Test (QCST) and who wore an activity monitor for 3 days. Predicted work capacity (VO 2max ) was determined using the QCST. Levels (h/day) of daily reclining, sitting, standing, walking (steps/day), and energy expenditure (MET∙h/day) were determined using an ActivPAL accelerometer. Hemoglobin concentrations (g/dL) were determined using a HemoCue photometer. Predetermined hierarchical (non-multilevel) regression models tested the independent associations between the primary study variables of interest (physical activity, hemoglobin concentrations) and predicted VO 2max , while adjusting for age, body mass index (BMI: kg/m 2 ), education, parity, and dietary diversity score. RESULTS Approximately 61% of the participants had anemia (Hb < 12 g/dL). Age 2 (β = - 0.01; 95% CI: - 0.01, 0.00), BMI (β = - 0.19; 95% CI:-0.28, - 0.09), educational attainment (β = - 1.35; 95% CI: - 2.34, - 0.36), and MET∙h/day (β = 0.19; 95% CI: 0.00, 0.38) were significant and independent determinants of work capacity. Hemoglobin concentration was marginally associated with work capacity in the presence of the other covariables (β = 0.22; 95% CI:-0.02, 0.47). CONCLUSIONS Our data indicate that factors other than anemia are important correlates of work capacity and should be considered when promoting the health and economic capacity of rural Indian women. TRIAL REGISTRATION Clinical Trial Registry- India (CTRI) http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=26285&EncHid=&userName=CTRI/2018/10/016186 on 29 October 2018.",2021,"Age 2 (β = - 0.01; 95% CI: - 0.01, 0.00), BMI (β = - 0.19; 95% CI:-0.28, - 0.09), educational attainment (β = - 1.35; 95% CI: - 2.34, - 0.36), and MET∙h/day (β = 0.19; 95% CI: 0.00, 0.38) were significant and independent determinants of work capacity.","['women (15-49\u2009years) living in Odisha, India between 2018 and 2021', 'rural Indian women', 'male and female workers', 'Women (2055/group) living in 15 selected clusters (40-41 villages', 'non-pregnant women of reproductive age living in rural India', 'non-pregnant women (n\u2009=\u2009330) living in rural India', '89 clusters of villages']","['Registry- India (CTRI', ""modified Queen's College Step Test (QCST) and who wore an activity monitor for 3 days""]","['interest (physical activity, hemoglobin concentrations) and predicted VO 2max , while adjusting for age, body mass index (BMI: kg/m 2 ), education, parity, and dietary diversity score', 'Anemia through Normative Innovations (RANI', 'Levels (h/day) of daily reclining, sitting, standing, walking (steps/day), and energy expenditure (MET∙h/day', 'Hemoglobin concentration', 'Hemoglobin concentrations', 'Predicted work capacity (VO 2max ', 'anemia ']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517719', 'cui_str': '330'}]","[{'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0043227', 'cui_str': 'Working'}]",,0.265917,"Age 2 (β = - 0.01; 95% CI: - 0.01, 0.00), BMI (β = - 0.19; 95% CI:-0.28, - 0.09), educational attainment (β = - 1.35; 95% CI: - 2.34, - 0.36), and MET∙h/day (β = 0.19; 95% CI: 0.00, 0.38) were significant and independent determinants of work capacity.","[{'ForeName': 'Loretta', 'Initials': 'L', 'LastName': 'DiPietro', 'Affiliation': 'Departments of Exercise & Nutrition Sciences, Milken Institute School of Public Health, The George Washington University, Washington, DC, USA. ldp1@gwu.edu.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bingenheimer', 'Affiliation': 'Departments of Prevention & Community Health, Milken Institute School of Public Health, The George Washington University, Washington, DC, USA.'}, {'ForeName': 'Sameera A', 'Initials': 'SA', 'LastName': 'Talegawkar', 'Affiliation': 'Departments of Exercise & Nutrition Sciences, Milken Institute School of Public Health, The George Washington University, Washington, DC, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Sedlander', 'Affiliation': 'Departments of Prevention & Community Health, Milken Institute School of Public Health, The George Washington University, Washington, DC, USA.'}, {'ForeName': 'Hagere', 'Initials': 'H', 'LastName': 'Yilma', 'Affiliation': 'Departments of Prevention & Community Health, Milken Institute School of Public Health, The George Washington University, Washington, DC, USA.'}, {'ForeName': 'Pratima', 'Initials': 'P', 'LastName': 'Pradhan', 'Affiliation': 'DCOR Consulting, Bhubaneswar, Odisha, India.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Rimal', 'Affiliation': 'Department of Health, Behavior & Society, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}]",BMC public health,['10.1186/s12889-021-10785-x'] 3933,33858395,The effect of a mindfulness-based stress intervention on neurobiological and symptom measures in adolescents with early life stress: a randomized feasibility study.,"BACKGROUND Early life stress (ELS) has been linked to poor mental and physical health outcomes in adolescence and adulthood. Mindfulness reduces symptoms of depression and anxiety and improves cognitive and social outcomes in both youth and adults. However, little is known whether mindfulness can mitigate against the adverse neurobiological and psychological effects of ELS. This study aimed to examine the feasibility of conducting a group mindfulness intervention in adolescents with ELS and provide preliminary indication of potential effects on stress-related biomarkers and mental health symptoms. METHODS Forty adolescents were randomized to receive either eight sessions of Mindfulness-Based Stress Reduction for Teens in group format (MBSR-T; n = 21) or Treatment as Usual Control group (CTRL; n = 17). Outcomes were assessed at baseline and follow-up and included measures associated with neurobiological functioning (immune and endocrine biomarkers) and self-reported mental health (depressive) symptoms. Linear mixed effects models were used to assess the effects of group and time on these outcome measures. RESULTS Sixteen of the 21 adolescents completed the intervention, attending an average of 6.5 sessions. The model examining cortisol responses to stress induction revealed medium effects trending toward significance (Cohen's d = .56) for anticipatory cortisol levels in the MBSR-T relative to CTRL groups. No significant effects were found in models examining C-reactive protein or interleukin 6 inflammatory markers. The model examining depressive symptoms revealed a medium effect for symptom reduction (Cohen's d = .69) in the MBSR-T relative to CTRL groups. CONCLUSIONS This study demonstrated feasibility of conducting a group-based MBSR-T intervention for adolescents with ELS. There was some evidence for efficacy on a symptom level with potential subtle changes on a biological level. Future larger studies are needed to determine the efficacy of group-based mindfulness interventions in this population. TRIAL REGISTRATION Identifier # NCT03633903 , registered 16/08/2018.",2021,The model examining cortisol responses to stress induction revealed medium effects trending toward significance (Cohen's d = .56) for anticipatory cortisol levels in the MBSR-T relative to CTRL groups.,"['adolescents with ELS', 'Forty adolescents', 'both youth and adults', 'adolescents with early life stress', 'Sixteen of the 21 adolescents completed the intervention, attending an average of 6.5 sessions']","['MBSR-T intervention', 'Mindfulness-Based Stress Reduction for Teens in group format (MBSR-T; n\u2009=\u200921) or Treatment as Usual Control group (CTRL', 'mindfulness-based stress intervention']","['neurobiological functioning (immune and endocrine biomarkers) and self-reported mental health (depressive) symptoms', 'anticipatory cortisol levels', 'models examining C-reactive\xa0protein or interleukin 6 inflammatory markers', 'depression and anxiety and improves cognitive and social outcomes']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C3844007', 'cui_str': '6.5'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",40.0,0.0402296,The model examining cortisol responses to stress induction revealed medium effects trending toward significance (Cohen's d = .56) for anticipatory cortisol levels in the MBSR-T relative to CTRL groups.,"[{'ForeName': 'Zsofia P', 'Initials': 'ZP', 'LastName': 'Cohen', 'Affiliation': 'Laureate Institute for Brain Research, 6655 S Yale Avenue, Tulsa, OK, 74136, USA.'}, {'ForeName': 'Kelly T', 'Initials': 'KT', 'LastName': 'Cosgrove', 'Affiliation': 'Laureate Institute for Brain Research, 6655 S Yale Avenue, Tulsa, OK, 74136, USA.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Akeman', 'Affiliation': 'Laureate Institute for Brain Research, 6655 S Yale Avenue, Tulsa, OK, 74136, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Coffey', 'Affiliation': 'Center for Health Sciences, Oklahoma State University - Tulsa, 1111 W 17th St, Tulsa, OK, 74107, USA.'}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Teague', 'Affiliation': 'Center for Health Sciences, Oklahoma State University - Tulsa, 1111 W 17th St, Tulsa, OK, 74107, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hays-Grudo', 'Affiliation': 'Center for Health Sciences, Oklahoma State University - Tulsa, 1111 W 17th St, Tulsa, OK, 74107, USA.'}, {'ForeName': 'Martin P', 'Initials': 'MP', 'LastName': 'Paulus', 'Affiliation': 'Laureate Institute for Brain Research, 6655 S Yale Avenue, Tulsa, OK, 74136, USA.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Aupperle', 'Affiliation': 'Laureate Institute for Brain Research, 6655 S Yale Avenue, Tulsa, OK, 74136, USA.'}, {'ForeName': 'Namik', 'Initials': 'N', 'LastName': 'Kirlic', 'Affiliation': 'Laureate Institute for Brain Research, 6655 S Yale Avenue, Tulsa, OK, 74136, USA. nkirlic@laureateinstitute.org.'}]",BMC complementary medicine and therapies,['10.1186/s12906-021-03295-1'] 3934,33858390,"Effect of various dialysis modalities on intradialytic hemodynamics, tissue injury and patient discomfort in chronic dialysis patients: design of a randomized cross-over study (HOLLANT).","BACKGROUND From a recent meta-analysis it appeared that online post-dilution hemodiafiltration (HDF), especially with a high convection volume (HV-HDF), is associated with superior overall and cardiovascular survival, if compared to standard hemodialysis (HD). The mechanism(s) behind this effect, however, is (are) still unclear. In this respect, a lower incidence of intradialytic hypotension (IDH), and hence less tissue injury, may play a role. To address these items, the HOLLANT study was designed. METHODS HOLLANT is a Dutch multicentre randomized controlled cross-over trial. In total, 40 prevalent dialysis patients will be included and, after a run-in phase, exposed to standard HD, HD with cooled dialysate, low-volume HDF and high-volume HDF (Dialog iQ® machine) in a randomized fashion. The primary endpoint is an intradialytic nadir in systolic blood pressure (SBP) of < 90 and < 100 mmHg for patients with predialysis SBP < 159 and ≥ 160 mmHg, respectively. The main secondary outcomes are 1) intradialytic left ventricle (LV) chamber quantification and deformation, 2) intradialytic hemodynamic profile of SBP, diastolic blood pressure (DBP), mean arterial pressure (MAP) and pulse pressure (PP), 3) organ and tissue damage, such as the release of specific cellular components, and 4) patient reported symptoms and thermal perceptions during each modality. DISCUSSION The current trial is primarily designed to test the hypothesis that a lower incidence of intradialytic hypotension contributes to the superior survival of (HV)-HDF. A secondary objective of this investigation is the question whether changes in the intradialytic blood pressure profile correlate with organ dysfunction and tissue damage, and/or patient discomfort. TRIAL REGISTRATION Registered Report Identifier: NCT03249532 # ( ClinicalTrials.gov ). Date of registration: 2017/08/15.",2021,"In this respect, a lower incidence of intradialytic hypotension (IDH), and hence less tissue injury, may play a role.","['40 prevalent dialysis patients', 'chronic dialysis patients']","['various dialysis modalities', 'standard HD, HD with cooled dialysate, low-volume HDF and high-volume HDF (Dialog iQ® machine']","['intradialytic nadir in systolic blood pressure (SBP', 'intradialytic hemodynamics, tissue injury and patient discomfort', '1) intradialytic left ventricle (LV) chamber quantification and deformation, 2) intradialytic hemodynamic profile of SBP, diastolic blood pressure (DBP), mean arterial pressure (MAP) and pulse pressure (PP), 3) organ and tissue damage, such as the release of specific cellular components, and 4) patient reported symptoms and thermal perceptions during each modality', 'intradialytic hypotension (IDH']","[{'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0011947', 'cui_str': 'Dialysis fluid'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0336779', 'cui_str': 'Machine'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C4552279', 'cui_str': 'Tissue injury'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0007799', 'cui_str': 'Brain ventricle structure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}]",,0.0842744,"In this respect, a lower incidence of intradialytic hypotension (IDH), and hence less tissue injury, may play a role.","[{'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Rootjes', 'Affiliation': 'Department of Nephrology and Amsterdam Cardiovascular Sciences (ACS), Amsterdam UMC, VU University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Menso J', 'Initials': 'MJ', 'LastName': 'Nubé', 'Affiliation': 'Department of Nephrology and Amsterdam Cardiovascular Sciences (ACS), Amsterdam UMC, VU University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Camiel L M', 'Initials': 'CLM', 'LastName': 'de Roij van Zuijdewijn', 'Affiliation': 'Department of Nephrology and Amsterdam Cardiovascular Sciences (ACS), Amsterdam UMC, VU University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Gertrude', 'Initials': 'G', 'LastName': 'Wijngaarden', 'Affiliation': 'Department of Nephrology and Amsterdam Cardiovascular Sciences (ACS), Amsterdam UMC, VU University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Muriel P C', 'Initials': 'MPC', 'LastName': 'Grooteman', 'Affiliation': 'Department of Nephrology and Amsterdam Cardiovascular Sciences (ACS), Amsterdam UMC, VU University of Amsterdam, Amsterdam, The Netherlands. mpc.grooteman@amsterdamumc.nl.'}]",BMC nephrology,['10.1186/s12882-021-02331-z'] 3935,33858336,Effectiveness of resistance training on resilience in Hong Kong Chinese older adults: study protocol for a randomized controlled trial.,"BACKGROUND There is on one hand sufficient evidence showing strong association between resilience and self-rated successful aging. On the other hand, strength training could contribute the cultivation of resilience among older adults. Therefore, the current study aims to examine the effectiveness of resistance training on resilience among Chinese older adults in Hong Kong. METHODS This study will apply a three-group, double blinded (outcome assessors and data analysts), randomized controlled trial (RCT) to examine the effectiveness of the interventions on resilience, functional fitness, and health related quality of life immediately after a 16-week intervention, as well as the residual effects 12 weeks after completion of the interventions. DISCUSSION It is expected that resistance training is promising or even superior to aerobic training in the improvement of resilience. Given the limited evidence on the literature, it is urgently needed to explore the effects of resistance training on the improvement of resilience in older adults. Findings of the current study can contribute to the development of effective resistant training programs for the promotion of resilience among older adults. TRIAL REGISTRATION The trial is registered at the ClinicalTrials.gov PRS (Trial ID: NCT04690465 ; Date of First Posted: 30/12/2020).",2021,"Findings of the current study can contribute to the development of effective resistant training programs for the promotion of resilience among older adults. ","['older adults', 'Hong Kong Chinese older adults', 'Chinese older adults in Hong Kong']","['strength training', 'resistance training']","['resilience, functional fitness, and health related quality of life']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0884943,"Findings of the current study can contribute to the development of effective resistant training programs for the promotion of resilience among older adults. ","[{'ForeName': 'Pak-Kwong', 'Initials': 'PK', 'LastName': 'Chung', 'Affiliation': 'Department of Sport, Physical Education and Health, Hong Kong Baptist University, 224 Waterloo Road, Kowloon Tong, Kowloon, Hong Kong, China. pkchung@hkbu.edu.hk.'}, {'ForeName': 'Chun-Qing', 'Initials': 'CQ', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychology, Sun Yat-sen University, Guangzhou, China. zhangchq28@mail.sysu.edu.cn.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'School of Sports Science and Physical Education, Nanjing Normal University, Nanjing, China.'}, {'ForeName': 'Ming Yu Claudia', 'Initials': 'MYC', 'LastName': 'Wong', 'Affiliation': 'Department of Sport, Physical Education and Health, Hong Kong Baptist University, 224 Waterloo Road, Kowloon Tong, Kowloon, Hong Kong, China.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': ""Student Mental Health Education Center, Northwestern Polytechnical University, Xi'an, China.""}]",BMC geriatrics,['10.1186/s12877-021-02197-8'] 3936,33858304,Does cognitive decline occur decades after moderate to severe traumatic brain injury? A prospective controlled study.,"This prospective controlled study examined long-term trajectories of neuropsychological performance in individuals with traumatic brain injury (TBI) compared to healthy controls, and the impact of IQ, age at injury, time since injury, and injury severity on change over time. Fifty-three individuals with moderate to severe TBI (60.37% male; M  = 59.77 yrs, SD   = 14.03), and 26 controls (46.15% male; M  = 63.96 yrs, SD   = 14.42) were studied prospectively ( M = 12.72 yrs between assessments). Participants completed measures of premorbid IQ (Weschler Test of Adult Reading), processing speed (Digit Symbol Coding Test), working memory (Digit Span Backwards), memory (Rey Auditory Verbal Learning Test) and executive function (Trail Making Test Part B; Hayling Errors), at a mean of 10.62 yrs (Initial) and 23.91 yrs (Follow-Up) post injury. Individuals with TBI did not show a significantly greater decline in neuropsychological performance over time compared with demographically similar controls. There was no association between change over time with IQ, time since injury or injury severity. Being older at injury had a greater adverse impact on executive function at follow-up. In this small sample, a single moderate to severe TBI was not associated with ongoing cognitive decline up to three decades post injury. Changes in cognitive function were similar between the groups and likely reflect healthy aging.",2021,Individuals with TBI did not show a significantly greater decline in neuropsychological performance over time compared with demographically similar controls.,"['yrs, SD \u2009 =\u200914.03), and 26 controls (46.15% male; M\u2009 =\u200963.96\u2005yrs, SD \u2009 =\u200914.42) were studied prospectively ( M = 12.72\u2005yrs between assessments', 'individuals with traumatic brain injury (TBI', 'Fifty-three individuals with moderate to severe TBI (60.37% male; M\u2009 =\u200959.77']",[],"['change over time with IQ, time since injury or injury severity', 'neuropsychological performance', 'executive function', 'premorbid IQ (Weschler Test of Adult Reading), processing speed (Digit Symbol Coding Test), working memory (Digit Span Backwards), memory (Rey Auditory Verbal Learning Test) and executive function (Trail Making Test Part B; Hayling Errors', 'cognitive function']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]",[],"[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449246', 'cui_str': 'Time since injury'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C4505058', 'cui_str': 'Rey Auditory Verbal Learning Test'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",53.0,0.0422269,Individuals with TBI did not show a significantly greater decline in neuropsychological performance over time compared with demographically similar controls.,"[{'ForeName': 'Amelia J', 'Initials': 'AJ', 'LastName': 'Hicks', 'Affiliation': 'Monash-Epworth Rehabilitation Research Centre, Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Gershon', 'Initials': 'G', 'LastName': 'Spitz', 'Affiliation': 'Monash-Epworth Rehabilitation Research Centre, Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Rowe', 'Affiliation': 'Department of Molecular Imaging and Therapy, Austin Health, Heidelberg and Florey Department of Neuroscience and Mental Health, University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Roberts', 'Affiliation': 'Monash-Epworth Rehabilitation Research Centre, Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Dean P', 'Initials': 'DP', 'LastName': 'McKenzie', 'Affiliation': 'Research Development and Governance Unit, Epworth HealthCare Melbourne, Australia and Department of Epidemiology and Preventive Medicine, Monash University Melbourne, Melbourne, Australia.'}, {'ForeName': 'Jennie L', 'Initials': 'JL', 'LastName': 'Ponsford', 'Affiliation': 'Monash-Epworth Rehabilitation Research Centre, Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Melbourne, Australia.'}]",Neuropsychological rehabilitation,['10.1080/09602011.2021.1914674'] 3937,33858234,The effect of early autism intervention on parental sense of efficacy in a randomized trial depends on the initial level of parent stress.,"LAY ABSTRACT This is a study of the secondary effects of interventions for young children with autism on their parents. Specifically, we were interested in the impact on parent's sense of efficacy, or how confident and competent a parent feels about themselves as a parent. We tested three ideas: (1) that the style of the intervention, whether it was more or less structured and whether the parent had a more or less formal role, would impact a parent's sense of efficacy; (2) that the intensity of the intervention, how many hours per week the intervention was delivered, would impact parental efficacy; and (3) that the parent's level of stress prior to intervention would impact how intensity and style effected efficacy. We randomly assigned 87 children with autism, age 13-30 months, into one of four conditions: 15 versus 25 intervention hours crossed with two different styles of intervention. We used statistical tests to examine these ideas. We found that parental efficacy was related to intervention intensity but not style. Parents with higher stress at the beginning of a 1-year, home-based, comprehensive intervention program had a higher sense of parenting efficacy if their child received lower intensity intervention; parents with lower stress at baseline had a higher sense of efficacy if their child received higher intensity intervention. If a parent can emerge from the process of diagnosis and early intervention with an increased sense that they can make a difference in their child's life (i.e. increased sense of efficacy), it may set the stage for meeting the long-term demands of parenting a child with autism.",2021,"Parents with higher stress at the beginning of a 1-year, home-based, comprehensive intervention program had a higher sense of parenting efficacy if their child received lower intensity intervention; parents with lower stress at baseline had a higher sense of efficacy if their child received higher intensity intervention.","['young children with autism on their parents', '87 children with autism, age 13-30\u2009months']",['early autism intervention'],['parenting efficacy'],"[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",87.0,0.0197683,"Parents with higher stress at the beginning of a 1-year, home-based, comprehensive intervention program had a higher sense of parenting efficacy if their child received lower intensity intervention; parents with lower stress at baseline had a higher sense of efficacy if their child received higher intensity intervention.","[{'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Estes', 'Affiliation': 'University of Washington, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Yoder', 'Affiliation': 'Vanderbilt University, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McEachin', 'Affiliation': 'Autism Partnership Foundation, USA.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Hellemann', 'Affiliation': 'University of Alabama at Birmingham, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Munson', 'Affiliation': 'University of Washington, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Greenson', 'Affiliation': 'University of Washington, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Rocha', 'Affiliation': 'University of California, Davis, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Gardner', 'Affiliation': 'Vanderbilt University, USA.'}, {'ForeName': 'Sally J', 'Initials': 'SJ', 'LastName': 'Rogers', 'Affiliation': 'University of California, Davis, USA.'}]",Autism : the international journal of research and practice,['10.1177/13623613211005613'] 3938,33858230,Educating caregivers of persons with cerebral palsy in night-time postural care: A randomized trial comparing two online training programs.,"OBJECTIVE Compare effectiveness of two differently formatted training programs in educating night-time postural care implementers. DESIGN Mixed-methods parallel-group double-blind design with random assignment. SETTING United States academic institution. PARTICIPANTS Thirty-eight adult caregivers/providers of children with cerebral palsy. INTERVENTIONS Both 2-hour online programs included content on night-time postural care evidence, risk-factor monitoring, sleep-system types, positioning methods, and assessments. Group A used interactive videos, Group B summary information with web-links. MAIN MEASURES We measured self-perceived competence via questionnaires (baseline, post-training, post-simulation) containing 4-point rating-scales of knowledge, ability, and confidence and measured positioning ability via a simulation observation instrument comprising 16 positioning-task ratings with space for describing performance. We recorded participant actions/statements using fieldnotes. RESULTS Thirty-eight completed training (19 per group). Group A (vs B) showed significantly greater self-perceived competence changes post-training (0.46 points (SE 0.17), P  = 0.008). Thirty-seven positioned a standardized ""client,"" with groups not differing significantly on total tasks completed correctly ( F (1, 92.32) = 1.91, P  = 0.17) averaging 11.85 (SE 0.83) and 12.60 (SE 0.84) of 16 tasks correct. Group A's post-positioning/simulation self-ratings were significantly associated with actual ability ( r  = 0.53, P  = 0.019). In both groups ⩾47% of caregivers incorrectly completed the tasks of placing head and neck in neutral and snugging up all [positioning] parts. CONCLUSION The sleep care positioning training program (interactive video-based format) is effective in building caregivers' self-perceived competence for night-time postural care. While the lesson was well-received by caregivers and considered a ""match [to their] learning style,"" the lesson did not lead to greater improvement in actual ability to position the ""client"" compared to control training.",2021,The sleep care positioning training program (interactive video-based format) is effective in building caregivers' self-perceived competence for night-time postural care.,"['Educating caregivers of persons with cerebral palsy in night-time postural care', 'United States academic institution', 'Thirty-eight adult caregivers/providers of children with cerebral palsy']","['sleep care positioning training program (interactive video-based format', 'interactive videos, Group B summary information with web-links']","['night-time postural care evidence, risk-factor monitoring, sleep-system types, positioning methods, and assessments', 'self-perceived competence changes post-training', 'self-perceived competence via questionnaires (baseline, post-training, post-simulation) containing 4-point rating-scales of knowledge, ability, and confidence and measured positioning ability via a simulation observation instrument comprising 16 positioning-task ratings with space for describing performance', 'actual ability']","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}]","[{'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}]",38.0,0.0140713,The sleep care positioning training program (interactive video-based format) is effective in building caregivers' self-perceived competence for night-time postural care.,"[{'ForeName': 'Jennifer Ann', 'Initials': 'JA', 'LastName': 'Hutson', 'Affiliation': 'Occupational Therapy, St. Catherine University, St. Paul, MN, USA.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Hodges', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'LeAnn', 'Initials': 'L', 'LastName': 'Snow', 'Affiliation': 'Division of Rehabilitation Science, Department of Rehabilitation Medicine, University of Minnesota, Minneapolis, MN, USA.'}]",Clinical rehabilitation,['10.1177/02692155211009484'] 3939,33858221,The effectiveness of a family-centred intervention after traumatic brain injury: A pragmatic randomised controlled trial.,"OBJECTIVES To determine the effectiveness of a family-centred intervention for patients with traumatic brain injury and family members. DESIGN Open-labelled, two-armed randomised controlled trial. SETTINGS Outpatient clinic and family residences. PARTICIPANTS Sixty-one patients (33 women) with traumatic brain injury, with mean (SD) age 43.8 (12.2), and 63 family members (33 women), with mean (SD) age 42.6 (11.3), were assign to intervention ( n  = 30 families) and control group ( n  = 31 families). INTERVENTION An eight-session single-family intervention to improve individual and family functioning. OUTCOME MEASURES Self-reported questionnaires at start-of-treatment, median (IQR) 11.4 (8.4, 15.9) months post-injury, and at two follow-ups, 2.7 (2.3, 3.8) and 9.2 (8.2, 9.9) months after start-of-treatment. Primary outcome measures were the SF-36 Mental Component Summary (MCS) and Caregiver Burden Scale (CGB). Secondary outcome measures were the Family Adaptability and Cohesion Evaluation Scale (FACES) and Quality of Life after Brain Injury Questionnaire (QOLIBRI). Group differences were analysed with linear mixed-model analysis for repeated measurements. RESULTS No significant between-group differences were found. The intervention group significantly improved on the MCS, the CGB and FACES in the treatment period, whereas the controls did not. The mean (SD) MCS change in the treatment period was 2.4 (1.1) points P  = 0.028 in the intervention group. Mean (SE) MCS scores were 47.9 (1.26) and 47.3 (1.27) in the intervention and control group at last follow-up. CONCLUSIONS Receiving an eight-session family intervention, in addition to specialised rehabilitation for the patients, was not superior to rehabilitation at a specialised traumatic brain injury outpatient clinic.",2021,"Receiving an eight-session family intervention, in addition to specialised rehabilitation for the patients, was not superior to rehabilitation at a specialised traumatic brain injury outpatient clinic.","['traumatic brain injury', 'Outpatient clinic and family residences', 'patients with traumatic brain injury and family members', 'Sixty-one patients (33 women) with traumatic brain injury, with mean (SD) age 43.8 (12.2), and 63 family members (33 women), with mean (SD) age 42.6 (11.3), were assign to intervention ( n \u2009=\u200930 families) and control group ( n \u2009=\u200931 families']",['family-centred intervention'],"['Mean (SE) MCS scores', 'mean (SD) MCS change', 'Family Adaptability and Cohesion Evaluation Scale (FACES) and Quality of Life after Brain Injury Questionnaire (QOLIBRI', 'MCS, the CGB and FACES', 'SF-36 Mental Component Summary (MCS) and Caregiver Burden Scale (CGB', 'Self-reported questionnaires at start-of-treatment, median (IQR']","[{'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.0869677,"Receiving an eight-session family intervention, in addition to specialised rehabilitation for the patients, was not superior to rehabilitation at a specialised traumatic brain injury outpatient clinic.","[{'ForeName': 'Mari S', 'Initials': 'MS', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Andelic', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Are H', 'Initials': 'AH', 'LastName': 'Pripp', 'Affiliation': 'Oslo Centre of Biostatistics and Epidemiology Research Support Services, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Tonje H', 'Initials': 'TH', 'LastName': 'Nordenmark', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Helene L', 'Initials': 'HL', 'LastName': 'Soberg', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Oslo University Hospital, Oslo, Norway.'}]",Clinical rehabilitation,['10.1177/02692155211010369'] 3940,33858215,Aerobic exercise for adolescent outpatients with persistent major depression: Feasibility and acceptability of moderate to vigorous group exercise in a clinically referred sample.,"AIMS To assess feasibility and acceptability of exercise in clinically referred adolescents with major depression. METHODS Outpatients12 to 17 years with mild to moderate persistent depression participated in a supervised, pulse monitored, 14-week aerobic exercise but without control group. Primary outcome was adherence and secondary was clinician-rated Quick Inventory of Depressive Symptomatology - Adolescent (QIDS-A 17 -C), aerobic capacity, functioning, and well-being. RESULTS Twenty-one (66%) of 32 eligible adolescents with major depression with disease duration 2.4 (1.1-5.3) years and comorbid ADHD (71%) and anxiety disorders (62%) consented. Estimated maximum heart rate above 70% was achieved for mean 31.6 minutes, indicating that the intensity and duration of the exercise intervention was well received. Fourteen patients (67%) participated throughout the program and attended a median of 29 (81%, range 20-35) supporting satisfaction with the intervention by most patients. QIDS-A 17 -C score decreased compared to baseline at 15 weeks ( p  < .001) and further at 1 year ( p  < .001). Aerobic capacity improved during the intervention but was not maintained, while functioning improved and after 1 year also well-being. CONCLUSION This 14 week moderate to vigorous aerobic exercise intervention was feasible and well accepted by most adolescents with persistent depression and extensive comorbidities.",2021,QIDS-A 17 -C score decreased compared to baseline at 15 weeks ( p  < .001) and further at 1 year ( p  < .001).,"['Fourteen patients (67%) participated throughout the program and attended a median of 29 (81%, range 20-35) supporting satisfaction with the intervention by most patients', 'adolescents with persistent depression and extensive comorbidities', 'adolescent outpatients with persistent major depression', 'Twenty-one (66%) of 32 eligible adolescents with major depression with disease duration 2.4 (1.1-5.3) years and comorbid ADHD (71%) and anxiety disorders (62%) consented', 'clinically referred adolescents with major depression', 'Outpatients12 to 17\u2009years with mild to moderate persistent depression participated in a']","['Aerobic exercise', 'supervised, pulse monitored, 14-week aerobic exercise but without control group', 'moderate to vigorous group exercise', 'vigorous aerobic exercise intervention']","['maximum heart rate', 'Aerobic capacity', 'QIDS-A 17 -C score', 'adherence and secondary was clinician-rated Quick Inventory of Depressive Symptomatology - Adolescent', 'aerobic capacity, functioning, and well-being']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0199614', 'cui_str': 'Monitoring of pulse'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C0050288', 'cui_str': 'A 17'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0502313,QIDS-A 17 -C score decreased compared to baseline at 15 weeks ( p  < .001) and further at 1 year ( p  < .001).,"[{'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Jarbin', 'Affiliation': 'Child and Adolescent Psychiatry, Region Halland, Sweden.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Höglund', 'Affiliation': 'Child and Adolescent Psychiatry, Region Halland, Sweden.'}, {'ForeName': 'Gudmundur', 'Initials': 'G', 'LastName': 'Skarphedinsson', 'Affiliation': 'Faculty of Psychology, University of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Bremander', 'Affiliation': 'Section of Rheumatology, Department of Clinical Sciences, Lund University, Sweden.'}]",Clinical child psychology and psychiatry,['10.1177/13591045211000782'] 3941,33858205,Comparison of the corticosteroid injection and hyaluronate in the treatment of chronic subacromial bursitis: A randomized controlled trial.,"OBJECTIVE To analyse the effectiveness of corticosteroid (CS) and hyaluronic acid (HA) subacromial - subdeltoid (SASD) injection compared with normal saline (NS) in patients with chronic subacromial bursitis (CSB). DESIGN A prospective three-arm double-blinded randomised controlled trial. SETTING Rehabilitation department of two teaching hospitals. SUBJECTS Patients with CSB ( N  = 186) divided into CS ( N  = 68), HA ( N  = 60), and NS ( N  = 58) groups. INTERVENTIONS Three SASD injections under ultrasound guidance: group A, 20 mg of triamcinolone; group B, 2.5 mL of HA; and group C, 2.5 mL of NS. OUTCOME MEASURES The primary outcome measures were the pain visual analogue scale (VAS) score at eight weeks. The secondary outcomes were scores on the Shoulder Pain and Disability Index (SPADI) and Shoulder Disability Questionnaire. RESULTS At eight weeks, the pain VAS scores during activity were 2.56 ± 2.29, 3.65 ± 2.50, and 4.71 ± 2.83 in the CS, HA, and NS groups, respectively (CS vs NS, P  < 0.001; HA vs NS, P  = 0.013; CS vs HA, P  = 0.010). SPADI scores were 40.83 ± 21.75, 36.92 ± 22.78, and 33.35 ± 23.38 in the CS, HA, and NS groups, respectively (CS vs NS, P  < 0.001; HA vs NS, P  = 0.197; CS vs HA, P  = 0.004). CONCLUSION Ultrasound-guided corticosteroid injection into the subacromial - subdeltoid bursa was proven to be effective and superior to hyaluronic acid and normal saline injection for treating CSB. Hyaluronic acid injection was only marginally more effective than normal saline injection. Trial Registration: ClinicalTrials.gov: NCT02702206.",2021,Hyaluronic acid injection was only marginally more effective than normal saline injection.,"['Patients with CSB ( N \u2009=\u2009186) divided into CS ( N \u2009=\u200968), HA ( N \u2009=\u200960), and NS ( N \u2009=\u200958) groups', 'chronic subacromial bursitis', 'patients with chronic subacromial bursitis (CSB', 'Rehabilitation department of two teaching hospitals']","['triamcinolone', 'corticosteroid (CS) and hyaluronic acid (HA) subacromial - subdeltoid (SASD) injection', 'corticosteroid injection and hyaluronate', 'Hyaluronic acid injection', 'HA', 'SASD injections under ultrasound guidance', 'normal saline (NS']","['Shoulder Pain and Disability Index (SPADI) and Shoulder Disability Questionnaire', 'pain visual analogue scale (VAS) score', 'pain VAS scores', 'SPADI scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751038', 'cui_str': 'Type II Cockayne Syndrome'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0546953', 'cui_str': 'Subacromial bursitis'}, {'cui': 'C0587478', 'cui_str': 'Rehabilitation department'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0178695', 'cui_str': 'hyaluronate'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.276161,Hyaluronic acid injection was only marginally more effective than normal saline injection.,"[{'ForeName': 'Lin-Fen', 'Initials': 'LF', 'LastName': 'Hsieh', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, Shin Kong Wu Ho-Su Memorial Hospital, Taipei.'}, {'ForeName': 'Yi-Jia', 'Initials': 'YJ', 'LastName': 'Lin', 'Affiliation': 'Graduate Institute of Biomedical Engineering, National Taiwan University of Science and Technology, Taipei.'}, {'ForeName': 'Wei-Chun', 'Initials': 'WC', 'LastName': 'Hsu', 'Affiliation': 'Graduate Institute of Biomedical Engineering, National Taiwan University of Science and Technology, Taipei.'}, {'ForeName': 'Ying-Chen', 'Initials': 'YC', 'LastName': 'Kuo', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, Shin Kong Wu Ho-Su Memorial Hospital, Taipei.'}, {'ForeName': 'Yu-Chia', 'Initials': 'YC', 'LastName': 'Liu', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, Shin Kong Wu Ho-Su Memorial Hospital, Taipei.'}, {'ForeName': 'Yi-Pin', 'Initials': 'YP', 'LastName': 'Chiang', 'Affiliation': 'Department of Rehabilitation Medicine, MacKay Memorial Hospital, Taipei.'}, {'ForeName': 'Chun-Ping', 'Initials': 'CP', 'LastName': 'Wang', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, Shin Kong Wu Ho-Su Memorial Hospital, Taipei.'}]",Clinical rehabilitation,['10.1177/02692155211007799'] 3942,33858020,[A Motivational-Volitional Program for Women after Breast Cancer Increases Physical Activity 12 Months Post Rehabilitation - Results of a Prospective Controlled Trial].,"PURPOSE To assess the effectiveness of a motivational-volitional program for women after breast cancer (MoVo-BnB) who engage less than 60 minutes per week in physical activity. METHODS This is a non-randomised, prospective bi-centered controlled trial in 2 in-patient medical rehabilitation centers. Data are assessed at 4 measurement points: at admission, discharge, 6 and 12 months post discharge. The control group (CG; n=266) has received the standard rehabilitation, and the intervention group (IG; n=279) attended additionally the group program (4 sessions lead by physiotherapeutic and health pedagogic personnel). The primary outcome is self-reported physical activity (BSA-F); secondary outcomes are health related quality of life (QLQ-C30), breast cancer specific quality of health (QLQ-BR23) and program acceptance. Analysis of change are performed by ANCOVA for each follow-up, adjusting for baseline values. RESULTS At 12 months follow up, the level of exercise in the intervention group is 22 min/week higher than in the control group (95% CI: 2,6 to 41.5; p=0.02). Further, 49.1% of the intervention group exercises for at least 60 min/week compared to 37.6% of the control group (p≤0.01). We have observed no significant differences between the groups for quality of life. The participants' evaluation of the intervention is positive and does not differ substantially between the 2 clinics (p=0.3). CONCLUSION Our findings demonstrate that a cognitive-behavioral program based on the motivation-volitional model can lead to long-term improvement in exercise behavior in breast cancer patients, who is initially minimally active. Physical activity should be encouraged after breast cancer diagnosis. The results suggest that practitioners working in cancer aftercare might like to consider using a motivational-volitional program for improving and maintaining physical activity behavior for physical sedentary target groups.",2021,"The participants' evaluation of the intervention is positive and does not differ substantially between the 2 clinics (p=0.3). ","['women after breast cancer (MoVo-BnB) who engage less than 60 minutes per week in physical activity', 'Women after Breast Cancer Increases Physical Activity 12 Months Post Rehabilitation ', '2 in-patient medical rehabilitation centers', 'breast cancer patients']","['Motivational-Volitional Program', 'motivational-volitional program']","['breast cancer specific quality of health (QLQ-BR23', 'self-reported physical activity (BSA-F); secondary outcomes are health related quality of life (QLQ-C30', 'quality of life', 'level of exercise']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0133525,"The participants' evaluation of the intervention is positive and does not differ substantially between the 2 clinics (p=0.3). ","[{'ForeName': 'Leonie', 'Initials': 'L', 'LastName': 'Adams', 'Affiliation': 'Pädagogische Hochschule Freiburg.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Feicke', 'Affiliation': 'Gesundheitsamt OrtenaukreisOffenburg.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Eckert', 'Affiliation': 'Karlsruher Institut für Technologie, Karlsruhe.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Spörhase', 'Affiliation': 'Pädagogische Hochschule Freiburg.'}, {'ForeName': 'Wiebke', 'Initials': 'W', 'LastName': 'Göhner', 'Affiliation': 'Katholische Hochschule Freiburg.'}, {'ForeName': 'Eva-Maria', 'Initials': 'EM', 'LastName': 'Bitzer', 'Affiliation': 'Pädagogische Hochschule Freiburg.'}]",Die Rehabilitation,['10.1055/a-1361-4858'] 3943,33858011,"Oral CBD-rich cannabis induces clinical but not endoscopic response in patients with Crohn's disease, a randomized controlled trial.","AIMS Despite reports that medical cannabis improves symptoms in Crohn's disease (CD), controlled studies evaluating disease response are lacking. This study assessed the effect of cannabidiol (CBD)-rich cannabis oil for induction of remission in CD. METHODS In a double-blind, randomized, placebo-controlled single center trial, patients received orally eithercannabis oil containing160/40mg/ml cannabidiol/ tetrahydrocannabinol (CBD/THC) or placebo for eight weeks. Disease parameters including CD activity index (CDAI), and simple endoscopic score for CD (SES-CD) were assessed before and after treatment. In a subgroup of patients, blood samples were collected for CBD and THC plasma levels. RESULTS The study included 56 patients, age 34.5±11 years, men/women 30/26 (54/46%), 30 in cannabis and 26 in placebo groups. CDAI at recruitment and after eight weeks was282(IQR243-342) and 166 (IQR 82-226) and 264(IQR 234-320) and 237(IQR 121-271) (p<0.05) in the cannabis and placebo groups, respectively. Median QOL score improved from 74 for both groups at baseline to 91 (IQR 85-102) and 75 (IQR 69-88) after 8 weeks in the cannabis and placebo groups, respectively (p=0.004). SES-CD was 10 (7-14) and 11 (IQR7-14), and 7 (4-14) and 8 (IQR 4-12;p=0.75)before and after treatment, in the cannabis and placebo groups, respectively. Inflammatory markers (CRP, calprotectin) remained unchanged. CONCLUSIONS Eight weeks of CBD-rich cannabis treatment induced significant clinical and QOL improvement without significant changes in inflammatory parameters or endoscopic scores. The oral CBD-rich cannabis extract was well absorbed. Until further studies are available, cannabis treatment in Crohn's disease should be used only in the context of clinical trials.",2021,"Inflammatory markers (CRP, calprotectin) remained unchanged. ","[""patients with Crohn's disease"", '56 patients, age 34.5±11 years, men/women 30/26 (54/46%), 30 in cannabis and 26 in placebo groups', ""Crohn's disease (CD""]","['orally eithercannabis oil containing160/40mg/ml cannabidiol/ tetrahydrocannabinol (CBD/THC) or placebo', 'placebo', 'cannabidiol (CBD)-rich cannabis oil', 'Oral CBD-rich cannabis']","['inflammatory parameters or endoscopic scores', 'SES-CD', 'CD activity index (CDAI), and simple endoscopic score for CD (SES-CD', 'Inflammatory markers (CRP, calprotectin', 'Median QOL score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0556617', 'cui_str': 'Cannabis oil'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0451071', 'cui_str': ""Crohn's disease activity index""}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0950624', 'cui_str': 'Calprotectin'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",56.0,0.505442,"Inflammatory markers (CRP, calprotectin) remained unchanged. ","[{'ForeName': 'Timna', 'Initials': 'T', 'LastName': 'Naftali', 'Affiliation': 'Institute of Gastroenterology and Hepatology, Meir Medical Center,KfarSaba,Israel.'}, {'ForeName': 'Lihi', 'Initials': 'L', 'LastName': 'Bar-Lev Schleider', 'Affiliation': 'Research Department, Tikun-OlamCannbit Pharmaceuticals, Tel Aviv, Israel.'}, {'ForeName': 'Shlomo', 'Initials': 'S', 'LastName': 'Almog', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Meiri', 'Affiliation': 'Department of Biology, Technion-Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Konikoff', 'Affiliation': 'Institute of Gastroenterology and Hepatology, Meir Medical Center,KfarSaba,Israel.'}]",Journal of Crohn's & colitis,['10.1093/ecco-jcc/jjab069'] 3944,33857946,"Cabergoline in Treatment of Methamphetamine-Dependent Patients and Its Effect on Serum Level of Glial Cell-Derived Neurotrophic Factor: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.","BACKGROUND Methamphetamine use disorder is an important public health problem, especially in the younger generation, and associated with various psychiatric, cognitive, social, economic, and legal issues. Cabergoline, a drug with dopaminergic properties and long half-life, has been considered for the treatment of stimulant dependence. The systemic use of cabergoline has been shown to increase glial cell-derived neurotrophic factor (GDNF) expression. OBJECTIVE In this study, we investigated the effects of cabergoline on the serum level of GDNF and its effect on abstaining from methamphetamine in individuals treated for methamphetamine use disorder. METHOD Sixty male subjects with methamphetamine use disorder were randomly assigned to 2 groups receiving cabergoline and placebo, respectively. During a 12-week follow-up, we compared the serum level of GDNF, urine test results for methamphetamine use, and depression scale between the 2 groups. RESULTS We found that serum GDNF was lower in subjects who used methamphetamine than healthy subjects (p < 0.0001). However, the serum level of GDNF was not associated with cabergoline use. The rising number of cases testing positive in the placebo group showed a trend resulting in no significant difference between cases testing positive and negative (p = 0.585) at the end of week 12. In the verum group, however, the significantly high number of cases who tested negative - sober - for substances observed in early stages (weeks 7-8) continued to remain significantly higher till the end of the study (p = 0.043), resembling an association between treatment with cabergoline and remaining sober. Although reduced during treatment, recovery from depression was not associated with cabergoline treatment. CONCLUSION The findings of this study confirmed the effect of cabergoline in reducing methamphetamine use. However, a serum level of the GDNF increase, as seen in animal studies, was not associated with cabergoline treatment of human subjects. This study was registered at the Iranian Registry of Clinical Trials (TRN:IRCT2015050422077N1, October 06, 2015, https://en.irct.ir/trial/19134).",2021,"The systemic use of cabergoline has been shown to increase glial cell-derived neurotrophic factor (GDNF) expression. ","['human subjects', 'Iranian Registry of Clinical Trials (TRN', 'Sixty male subjects with methamphetamine use disorder', 'individuals treated for methamphetamine use disorder']","['placebo', 'Cabergoline', 'methamphetamine', 'cabergoline', 'Placebo', 'cabergoline and placebo']","['serum level of GDNF', 'serum level of GDNF, urine test results for methamphetamine use, and depression scale', 'serum GDNF']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0107994', 'cui_str': 'cabergoline'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027836', 'cui_str': 'Glia'}, {'cui': 'C0027754', 'cui_str': 'Nerve growth factor'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",60.0,0.057269,"The systemic use of cabergoline has been shown to increase glial cell-derived neurotrophic factor (GDNF) expression. ","[{'ForeName': 'Mohammadesmaeil', 'Initials': 'M', 'LastName': 'Alipour', 'Affiliation': 'Department of Neuroscience and Addiction Studies, MD, PhD Candidate in Addiction Studies, School of Advanced Technologies in Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Jafarian', 'Affiliation': 'Brain and Spinal Cord Injury Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Rastgoo', 'Affiliation': 'Department of Neuroscience and Addiction Studies, MD, PhD Candidate in Addiction Studies, School of Advanced Technologies in Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Azarakhsh', 'Initials': 'A', 'LastName': 'Mokri', 'Affiliation': 'Department of Psychiatry, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Gorji', 'Affiliation': 'Epilepsy Research Center, Westfalische Wilhelms-Universität Münster, Münster, Germany.'}, {'ForeName': 'Mohammad R', 'Initials': 'MR', 'LastName': 'Zarrindast', 'Affiliation': 'Department of Neurosciences and Addiction Studies, School of Advanced Technologies in Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Lorestani', 'Affiliation': 'Department of Psychology, Faculty of Humaities, Saveh Islamic Azad University, Saveh, Iran.'}, {'ForeName': 'Emran M', 'Initials': 'EM', 'LastName': 'Razaghi', 'Affiliation': 'Department of Psychiatry, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}]",European addiction research,['10.1159/000515398'] 3945,33857943,"Efficacy of Individualized Homeopathic Medicines in the Treatment of Atopic Dermatitis in Adults: A Double-Blind, Randomized, Placebo-Controlled, Preliminary Trial.","INTRODUCTION Individualized homeopathy (IH) in atopic dermatitis (AD) remained under-researched. OBJECTIVE We aimed at evaluating efficacy of IH in AD. METHODS A double-blind, randomized, placebo-controlled, short-term, preliminary trial was conducted in an Indian homeopathy hospital. Patients were randomized to either IH (n = 30) or identical-looking placebo (n = 30) using computerized randomization and allocation. Outcomes were patient-oriented scoring of AD (PO-SCORAD; primary end point), Dermatological Life Quality Index (DLQI) score, and AD burden score for adults (ADBSA; secondary end points), measured monthly for 3 months. An intention-to-treat sample was analyzed after adjusting baseline differences. RESULTS On PO-SCORAD, improvement was higher in IH against placebo, but nonsignificant statistically (pmonth 1 = 0.433, pmonth 2 = 0.442, pmonth 3 = 0.229). Secondary outcomes were also nonsignificant - both DLQI and ADBSA (p > 0.05). Four adverse events (diarrhea, injury, common cold) were recorded. CONCLUSIONS There was a small, but nonsignificant direction of effect towards homeopathy, which renders the trial inconclusive. A properly powered robust trial is indicated.",2021,"On PO-SCORAD, improvement was higher in IH against placebo, but nonsignificant statistically (pmonth 1 = 0.433, pmonth 2 = 0.442, pmonth 3 = 0.229).","['Atopic Dermatitis in Adults', 'Indian homeopathy hospital']","['IH', 'placebo', 'Individualized Homeopathic Medicines', 'Placebo', 'identical-looking placebo']","['Four adverse events (diarrhea, injury, common cold', 'nonsignificant - both DLQI and ADBSA', 'Dermatological Life Quality Index (DLQI) score, and AD burden score for adults (ADBSA']","[{'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0684199', 'cui_str': 'Homeopathic therapy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0684199', 'cui_str': 'Homeopathic therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205280', 'cui_str': 'Identical'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0009443', 'cui_str': 'Common cold'}, {'cui': 'C0011625', 'cui_str': 'DERMATOLOGICALS'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}]",30.0,0.916178,"On PO-SCORAD, improvement was higher in IH against placebo, but nonsignificant statistically (pmonth 1 = 0.433, pmonth 2 = 0.442, pmonth 3 = 0.229).","[{'ForeName': 'Samit', 'Initials': 'S', 'LastName': 'Dey', 'Affiliation': 'Department of Repertory, D.N. De Homoeopathic Medical College and Hospital, Government of West Bengal (affiliated to the West Bengal University of Health Sciences, Government of West Bengal), Kolkata, India.'}, {'ForeName': 'Abdur Rahaman', 'Initials': 'AR', 'LastName': 'Shaikh', 'Affiliation': 'D.N. De Homoeopathic Medical College and Hospital, Government of West Bengal (affiliated to the West Bengal University of Health Sciences, Government of West Bengal), Kolkata, India.'}, {'ForeName': 'Sangita', 'Initials': 'S', 'LastName': 'Saha', 'Affiliation': 'Department of Organon of Medicine and Homoeopathic Philosophy, Calcutta Homoeopathic Medical College and Hospital (affiliated to the West Bengal University of Health Sciences, Government of West Bengal), Kolkata, India.'}, {'ForeName': 'Ekta', 'Initials': 'E', 'LastName': 'Agrawal', 'Affiliation': 'Department. of Repertory, National Institute of Homoeopathy, Ministry of AYUSH, Government of India (affiliated to the West Bengal University of Health Sciences, Government of West Bengal), Kolkata, India.'}, {'ForeName': 'Ashish Kumar', 'Initials': 'AK', 'LastName': 'Gautam', 'Affiliation': 'Department. of Repertory, National Institute of Homoeopathy, Ministry of AYUSH, Government of India (affiliated to the West Bengal University of Health Sciences, Government of West Bengal), Kolkata, India.'}, {'ForeName': 'Avaranjika', 'Initials': 'A', 'LastName': 'Karuppusamy', 'Affiliation': 'Department of Materia Medica, National Institute of Homoeopathy, Ministry of AYUSH, Government of India (affiliated to the West Bengal University of Health Sciences, Government of West Bengal), Kolkata, India.'}, {'ForeName': 'Satarupa', 'Initials': 'S', 'LastName': 'Sadhukhan', 'Affiliation': 'Department of Organon of Medicine and Homoeopathic Philosophy, National Institute of Homoeopathy, Ministry of AYUSH, Government of India (affiliated to the West Bengal University of Health Sciences, Government of West Bengal), Kolkata, India.'}, {'ForeName': 'Souvik', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Department of Organon of Medicine and Homoeopathic Philosophy, D.N. De Homoeopathic Medical College and Hospital, Government of West Bengal (affiliated to the West Bengal University of Health Sciences, Government of West Bengal), Kolkata, India.'}, {'ForeName': 'Sk Swaif', 'Initials': 'SS', 'LastName': 'Ali', 'Affiliation': 'Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Government of West Bengal (affiliated to the West Bengal University of Health Sciences, Government of West Bengal), Howrah, India.'}, {'ForeName': 'Anamika', 'Initials': 'A', 'LastName': 'Basu', 'Affiliation': 'Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Government of West Bengal (affiliated to the West Bengal University of Health Sciences, Government of West Bengal), Howrah, India.'}, {'ForeName': 'Munmun', 'Initials': 'M', 'LastName': 'Koley', 'Affiliation': 'Department of Organon of Medicine and Homoeopathic Philosophy, State National Homoeopathic Medical College and Hospital, Lucknow, India.'}, {'ForeName': 'Subhranil', 'Initials': 'S', 'LastName': 'Saha', 'Affiliation': 'Department of Organon of Medicine and Homoeopathic Philosophy, D.N. De Homoeopathic Medical College and Hospital, Government of West Bengal (affiliated to the West Bengal University of Health Sciences, Government of West Bengal), Kolkata, India, drsubhranilsaha@hotmail.com.'}]",Complementary medicine research,['10.1159/000516026'] 3946,33857914,"Randomised clinical trial: Efficacy and safety of Qing-Chang-Hua-Shi granules in a multicenter, randomized, and double-blind clinical trial of patients with moderately active ulcerative colitis.","Qing-Chang-Hua-Shi (QCHS) is a Chinese herbal formula, which is composed of 11 herbs. Studies have also shown that QCHS granules can alleviate colitis in animal models by preventing inflammatory responses and suppressing apoptosis through the MEK/ERK signaling pathway. To determine the efficacy and safety of QCHS granules in patients with moderately active UC. We performed a multicenter, randomized, placebo-controlled, double-blind study of patients with moderately active UC who did not respond to 4 weeks of mesalazine therapy at the maximum dose. Patients were randomly assigned to groups and administered QCHS granules (125 g/day, n = 59) or an identical placebo, which was similar to the QCHS granules in color and taste (125 g/day, n = 60), with continued 5-ASA 4 g/d therapy for 12 weeks. The primary outcome was the rate of clinical response and clinical remission at week 12. The secondary outcomes were health-related quality of life, endoscopic response rate, and mucosal healing rate. Any changes in mucus/bloody stool and diarrhea were recorded. Out of the 119 enrolled patients at 10 different centers in China, 102 patients completed the trial. Clinical remission and clinical response were seen in 31.48% and 92.59% of QCHS-treated patients, and 12.50% and 72.92% of placebo-treated patients, respectively. There was a significant difference between the two treatment groups. More patients receiving QCHS granules vs. placebo achieved remission of mucus/bloody stool (70.37% vs. 47.92%, P = 0.0361). Adverse event rates were similar (QCHS granules 38.33%; placebo 25.42%). In conclusion, QCHS granules were superior to the placebo in introducing clinical remission and mucosal healing, as well as in relieving mucus/blood stool in patients with moderately active and 5-ASA-refractory UC.",2021,"More patients receiving QCHS granules vs. placebo achieved remission of mucus/bloody stool (70.37% vs. 47.92%, P = 0.0361).","['patients with moderately active UC', 'patients with moderately active and 5-ASA-refractory UC', 'patients with moderately active UC who did not respond to 4 weeks of mesalazine therapy at the maximum dose', '119 enrolled patients at 10 different centers in China, 102 patients completed the trial', 'patients with moderately active ulcerative colitis']","['QCHS granules', 'Qing-Chang-Hua-Shi (QCHS', 'identical placebo', 'Qing-Chang-Hua-Shi granules', 'placebo']","['Clinical remission and clinical response', 'clinical remission and mucosal healing', 'efficacy and safety of QCHS granules', 'health-related quality of life, endoscopic response rate, and mucosal healing rate', 'Adverse event rates', 'remission of mucus/bloody stool', 'mucus/bloody stool and diarrhea', 'rate of clinical response and clinical remission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0127615', 'cui_str': 'mesalamine'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}]","[{'cui': 'C0027452', 'cui_str': 'National Health Insurance'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027452', 'cui_str': 'National Health Insurance'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026727', 'cui_str': 'Mucus'}, {'cui': 'C0018932', 'cui_str': 'Hematochezia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",119.0,0.227437,"More patients receiving QCHS granules vs. placebo achieved remission of mucus/bloody stool (70.37% vs. 47.92%, P = 0.0361).","[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Shen', 'Affiliation': 'Affiliated Hospital of Nanjing University of Chinese Medicine (Jiangsu Province Hospital of Chinese Medicine), Nanjing 210029, China.'}, {'ForeName': 'Shengsheng', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Beijing, China.'}, {'ForeName': 'Wenxia', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'The First Affiliated Hospital of Henan University of CM, Zhengzhou, China.'}, {'ForeName': 'Shunping', 'Initials': 'S', 'LastName': 'Ren', 'Affiliation': 'The Hospital of Shanxi University of Chinese Medicine, Taiyuan, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Ke', 'Affiliation': 'The Second Affiliated Hospital of Fujian Traditional Chinese Medical University, Fuzhou, China.'}, {'ForeName': 'Qinghua', 'Initials': 'Q', 'LastName': 'Gu', 'Affiliation': 'Nantong Hospital of Traditional Chinese Medicine, Nantong, China.'}, {'ForeName': 'Zhipeng', 'Initials': 'Z', 'LastName': 'Tang', 'Affiliation': 'LongHua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Jingri', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Haerbin, China.'}, {'ForeName': 'Suning', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Shengjing Hospital of China Medicine University, Shenyang, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'GuangDong Province Hospital of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Jiandong', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': 'Affiliated Hospital of Nanjing University of Chinese Medicine (Jiangsu Province Hospital of Chinese Medicine), Nanjing 210029, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Affiliated Hospital of Nanjing University of Chinese Medicine (Jiangsu Province Hospital of Chinese Medicine), Nanjing 210029, China.'}, {'ForeName': 'Zhaofeng', 'Initials': 'Z', 'LastName': 'Shen', 'Affiliation': 'Affiliated Hospital of Nanjing University of Chinese Medicine (Jiangsu Province Hospital of Chinese Medicine), Nanjing 210029, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Zheng', 'Affiliation': 'Affiliated Hospital of Nanjing University of Chinese Medicine (Jiangsu Province Hospital of Chinese Medicine), Nanjing 210029, China.'}, {'ForeName': 'Yajun', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Affiliated Hospital of Nanjing University of Chinese Medicine (Jiangsu Province Hospital of Chinese Medicine), Nanjing 210029, China.'}, {'ForeName': 'Peiqing', 'Initials': 'P', 'LastName': 'Gu', 'Affiliation': 'Affiliated Hospital of Nanjing University of Chinese Medicine (Jiangsu Province Hospital of Chinese Medicine), Nanjing 210029, China.'}, {'ForeName': 'Jiafei', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'Affiliated Hospital of Nanjing University of Chinese Medicine (Jiangsu Province Hospital of Chinese Medicine), Nanjing 210029, China.'}, {'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Affiliated Hospital of Nanjing University of Chinese Medicine (Jiangsu Province Hospital of Chinese Medicine), Nanjing 210029, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Affiliated Hospital of Nanjing University of Chinese Medicine (Jiangsu Province Hospital of Chinese Medicine), Nanjing 210029, China. Electronic address: zhulei5100@163.com.'}]",Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie,['10.1016/j.biopha.2021.111580'] 3947,33857858,"Sanitation, financial incentives and health spillovers: A cluster randomised trial.","Poor sanitation and its consequent negative health outcomes continue to plague the developing world. Drawing on the finding that financial subsidies have changed behaviour in other health contexts, we conducted a clustered randomised trial in 160 villages in Lao PDR to evaluate the effectiveness of combining financial incentives with Community-Led Total Sanitation (CLTS), a widely-conducted behaviour change program. Villages were randomly allocated to four groups, all of which received CLTS but differed in the type of subsidy offered (none, household, village or both). Using data from a random sample of households with young children and village administrative data, we show that household incentives increased sanitation take-up among the poor, whereas a village incentive increased take-up primarily among the non-poor. Improved sanitation produced positive health spillovers - a 10 percentage point increase in village sanitation coverage decreased the probability of childhood stunting by 3 percentage points.",2021,Improved sanitation produced positive health spillovers - a 10 percentage point increase in village sanitation coverage decreased the probability of childhood stunting by 3 percentage points.,"['households with young children and village administrative data', '160 villages in Lao PDR']","['Community-Led Total Sanitation (CLTS', 'CLTS']","['Sanitation, financial incentives and health spillovers']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C1292785', 'cui_str': 'Administrative action'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0023033', 'cui_str': 'Lao language'}, {'cui': 'C1845050', 'cui_str': 'Pigmentary Disorder, Reticulate, with Systemic Manifestations'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}]","[{'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",160.0,0.0628355,Improved sanitation produced positive health spillovers - a 10 percentage point increase in village sanitation coverage decreased the probability of childhood stunting by 3 percentage points.,"[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Cameron', 'Affiliation': 'Melbourne Institute: Applied Economic and Social Research, Level 5, FBE Building, 111 Barry St, University of Melbourne, 3010, Vic., Australia. Electronic address: lisa.cameron@unimelb.edu.au.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Santos', 'Affiliation': 'Monash University.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Asian Development Bank.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Albert', 'Affiliation': 'Aquaya Institute.'}]",Journal of health economics,['10.1016/j.jhealeco.2021.102456'] 3948,33857850,The effects of Fushen Granule on the composition and function of the gut microbiota during Peritoneal Dialysis-Related Peritonitis.,"BACKGROUND Peritoneal dialysis (PD) is an acknowledged treatment for patients with irreversible kidney failure. The treatment usually causes peritoneal dialysis-related peritonitis (PDRP), a common complication of PD that can lead to inadequate dialysis, gastrointestinal dysfunction, and even death. Recent studies indicated that Fushen Granule (FSG), a Chinese herbal formula, improves the treatment of PD. However, the mechanism of how FSG plays its role in the improvement is still unclear. Gut microbiota has been closely related to the development of various diseases. We carried out a randomized controlled trial to assess whether FSG can modulate the gut microbiota during PDRP treatment. METHODS Forty-two PDRP patients were recruited into the clinical trial, and they were randomly divided into control(CON), probiotics(PRO) or Fushen granule group(FSG). To check whether FSG improve the PD treatment, we assessed the clinical parameters, including albumin(ALB), hemoglobin(HGB), blood urea nitrogen(BUN) and creatinine(CR). Fecal samples were collected before hospitalization and discharge, and stored at -80°C within 1 hour. And we assessed the microbial population and function by applying the 16S rRNA gene sequencing and functional enrichment analysis. RESULTS Compared to control group, ALB is improved in both probiotics and FSG groups, while HGB is increased but BUN and CR is reduced in FSG group. Sequencing of 16S rRNA genes revealed that FSG and PRO affected the composition of the microbial community. FSG significantly increased a abundant represented by Bacteroides, Megamonas and Rothia, which was significantly correlated with the improvements in carbohydrate and amino acid metabolism. CONCLUSIONS This study demonstrates that FSG ameliorates the nutritional status and improves the quality of life by enriching beneficial bacteria associated with metabolism. These results indicate that FSG as alternative medicine is a promising treatment for patients with PDRP.",2021,"FSG significantly increased a abundant represented by Bacteroides, Megamonas and Rothia, which was significantly correlated with the improvements in carbohydrate and amino acid metabolism. ","['patients with PDRP', 'Forty-two PDRP patients', 'patients with irreversible kidney failure']","['FSG', 'control(CON), probiotics(PRO) or Fushen granule group(FSG', 'Fushen Granule (FSG', 'Peritoneal dialysis (PD']","['FSG', 'quality of life', 'carbohydrate and amino acid metabolism', 'clinical parameters, including albumin(ALB), hemoglobin(HGB), blood urea nitrogen(BUN) and creatinine(CR', 'BUN and CR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0031154', 'cui_str': 'Peritonitis'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}]","[{'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}]","[{'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0600137', 'cui_str': 'Blood urea nitrogen'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}]",42.0,0.0698171,"FSG significantly increased a abundant represented by Bacteroides, Megamonas and Rothia, which was significantly correlated with the improvements in carbohydrate and amino acid metabolism. ","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': 'Department of Nephrology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, PR China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'Department of Nephrology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, PR China.'}, {'ForeName': 'Hangxing', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Nephrology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, PR China.'}, {'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Jiaqi', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Nephrology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, PR China.'}, {'ForeName': 'Xinyue', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Nephrology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, PR China.'}, {'ForeName': 'Lingyun', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Division of Nephrology, Department of Medicine, Nephrology Research and Training Center, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Hongtao', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Nephrology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, PR China. Electronic address: tjzyyht@163.com.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2021.153561'] 3949,33857827,Educational guidance for functional visual diversity in Nicaragua. Design and evaluation of a teacher-training program.,"The article exposes the process of design and implementation of a training program for teachers that teach people with Visual Functional Diversity (VFD), taking into account their needs both in training and in the provision of resources in Nicaragua. To verify the effectiveness of the program, a quasi-experimental design was carried out with a non-equivalent pretest and posttest control group. The experimental group received training while the control group did not receive training. The evaluation of the results obtained after the application of the program was carried out through two instruments: an efficacy questionnaire and a satisfaction questionnaire. The results showed significant differences between the experimental and control group after the application of the program (Z = -4,383; p = 0.000) in favor of the experimental group. It is confirmed that the program is effective in training teachers on inclusive education for the visually impaired as the teachers who took part in the training program significantly increased their knowledge in that issue.",2021,It is confirmed that the program is effective in training teachers on inclusive education for the visually impaired as the teachers who took part in the training program significantly increased their knowledge in that issue.,"['teachers that teach people with Visual Functional Diversity (VFD', 'Nicaragua']","['teacher-training program', 'training while the control group did not receive training']",['efficacy questionnaire and a satisfaction questionnaire'],"[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0028002', 'cui_str': 'Nicaragua'}]","[{'cui': 'C4082803', 'cui_str': 'Teacher Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.00156379,It is confirmed that the program is effective in training teachers on inclusive education for the visually impaired as the teachers who took part in the training program significantly increased their knowledge in that issue.,"[{'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Tregón-Martín', 'Affiliation': 'Department of Education Sciences, University of Zaragoza, Facultad de Ciencias Sociales y Humanas, C/ Atarazana 2, 44003, Teruel, Spain. Electronic address: nuritre@unizar.es.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Valero Valero', 'Affiliation': 'Office for Development Cooperation and Solidarity, Universidad Jaume I, Av. Vicent Sos Baynat, s/n 12071, Castellón de la Plana, Spain. Electronic address: valero@uji.es.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Flores Buils', 'Affiliation': 'Department of Developmental, Educational, Social Psychology and Methodology, Jaume I University, Facultad de Ciencias Humanas y Sociales, Av. Vicent Sos Baynat, s/n 12071, Castellón de la Plana, Spain. Electronic address: flores@uji.es.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Caballer Miedes', 'Affiliation': 'Department of Developmental, Educational, Social Psychology and Methodology, Jaume I University, Facultad de Ciencias Humanas y Sociales, Av. Vicent Sos Baynat, s/n 12071, Castellón de la Plana, Spain. Electronic address: caballer@uji.es.'}]",Evaluation and program planning,['10.1016/j.evalprogplan.2021.101948'] 3950,33857800,The feasibility and efficacy of a serial reaction time task that measures motor learning of anticipatory stepping.,"BACKGROUND Motor learning has been investigated using various paradigms, including serial reaction time tasks (SRTT) that examine upper extremity reaching and pointing while seated. Few studies have used a stepping SRTT, which could offer additional insights into motor learning involving postural demands. For a task to measure motor learning, naïve participants must demonstrate a) improved performance with task practice, and b) a dose-response relationship to learning the task. RESEARCH QUESTION Is a stepping SRTT feasible and efficacious for measuring motor learning? METHODS In this prospective study, 20 participants stood on an instrumented mat and were presented with stimuli on a computer screen. They stepped to the corresponding positions on the mat as quickly as possible. Presented stimuli included random sequences and a blinded imbedded repeating sequence. Three days after completing the randomly assigned practice dose [high dose group (n = 10) performed 4320 steps; low dose group (n = 10) performed 144 steps], a retention test of 72 steps was performed. Feasibility was measured as the proportion of participants who completed the assigned practice dose without adverse events. Efficacy was measured as within-group performance improvement on the random sequences and on the repeating sequence (paired t-tests), as well as a dose-response relationship to learning both types of sequences (independent t-tests). RESULTS All participants (mean age 26.8 years) completed all practice sessions without adverse events, indicating feasibility. High dose practice resulted in performance improvement while low dose did not; a dose-response relationship was found, with high dose practice resulting in greater learning of the task than low dose practice, indicating efficacy. SIGNIFICANCE This stepping SRTT is a feasible and efficacious way to measure motor learning, which could provide critical insights into anticipatory stepping, postural control, and fall risk. Future research is needed to determine feasibility, efficacy, and optimal practice dosages for older and impaired populations.",2021,"High dose practice resulted in performance improvement while low dose did not; a dose-response relationship was found, with high dose practice resulting in greater learning of the task than low dose practice, indicating efficacy. ","['20 participants stood on an instrumented mat and were presented with stimuli on a computer screen', 'All participants (mean age 26.8 years']",['serial reaction time task'],['Efficacy'],"[{'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0066317', 'cui_str': 'methylallyl trisulfide'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",20.0,0.0577011,"High dose practice resulted in performance improvement while low dose did not; a dose-response relationship was found, with high dose practice resulting in greater learning of the task than low dose practice, indicating efficacy. ","[{'ForeName': 'Geneviève N', 'Initials': 'GN', 'LastName': 'Olivier', 'Affiliation': 'Physical Therapy and Athletic Training, University of Utah, Salt Lake City, UT, USA. Electronic address: g.olivier@utah.edu.'}, {'ForeName': 'Serene S', 'Initials': 'SS', 'LastName': 'Paul', 'Affiliation': 'Physical Therapy and Athletic Training, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Walter', 'Affiliation': 'Physical Therapy and Athletic Training, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Hayes', 'Affiliation': 'Physical Therapy and Athletic Training, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'K Bo', 'Initials': 'KB', 'LastName': 'Foreman', 'Affiliation': 'Physical Therapy and Athletic Training, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Duff', 'Affiliation': 'Neurology, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Sydney Y', 'Initials': 'SY', 'LastName': 'Schaefer', 'Affiliation': 'Biological and Health Systems Engineering, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Leland E', 'Initials': 'LE', 'LastName': 'Dibble', 'Affiliation': 'Physical Therapy and Athletic Training, University of Utah, Salt Lake City, UT, USA.'}]",Gait & posture,['10.1016/j.gaitpost.2021.04.002'] 3951,33857789,Efficacy and safety of apixaban for primary prevention in gastrointestinal cancers: A post-hoc analysis of the AVERT trial.,"BACKGROUND Recent trials have demonstrated that thromboprophylaxis using direct oral anticoagulants is effective but associated with a higher rate of major bleeding in intermediate-to-high risk (Khorana score ≥ 2) patients with cancer initiating systemic chemotherapy. Patients with gastrointestinal cancer may be at higher risk of major bleeding complications. We sought to assess the efficacy and safety of using thromboprophylaxis with apixaban in this patient population. METHODS This is a post-hoc analysis of the AVERT trial, which was a randomized, placebo-controlled, double-blind clinical trial. The primary efficacy outcome was objectively documented venous thromboembolism within 180 days of randomization. The primary safety outcome was a major bleeding episode. Time-to-event analyses were performed in patients with gastrointestinal cancers (upper gastrointestinal, pancreatic/hepatobiliary and colorectal cancers). RESULTS A total of 130 patients from the original AVERT trial were included, with 65 patients allocated to each of the apixaban and placebo groups. VTE occurred in 3 (4.6%) patients in the apixaban group and 13 (20%) patients in the placebo group (HR: 0.27; 95% CI: 0.13-0.54; p = 0.0002). Major bleeding occurred in 2 (3.1%) patients in the apixaban group and 1 (1.5%) patient in the placebo group (HR 2.39, 95% CI 0.29-19.78, p = 0.42). None of the major bleeding events occurred in patients with upper gastrointestinal or colorectal cancers. CONCLUSION Primary thromboprophylaxis with apixaban therapy seems to be safe and effective in patients with gastrointestinal cancers. Major bleeding complications are uncommon in our cohort. (Funded by the CIHR and Bristol-Myers Squibb-Pfizer Alliance; NCT02048865).",2021,VTE occurred in 3 (4.6%) patients in the apixaban group and 13 (20%) patients in the placebo group (HR: 0.27; 95% CI: 0.13-0.54; p = 0.0002).,"['gastrointestinal cancers', 'patients with gastrointestinal cancers (upper gastrointestinal, pancreatic/hepatobiliary and colorectal cancers', 'patients with gastrointestinal cancers', 'Patients with gastrointestinal cancer', '130 patients from the original AVERT trial were included, with 65 patients allocated to each of the']","['apixaban and placebo', 'placebo', 'apixaban therapy', 'apixaban']","['VTE', 'major bleeding events', 'venous thromboembolism', 'major bleeding episode', 'Major bleeding complications', 'Major bleeding', 'efficacy and safety', 'Efficacy and safety']","[{'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3203348', 'cui_str': 'Upper gastrointestinal tract structure'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C3160769', 'cui_str': 'Major bleed'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",130.0,0.256857,VTE occurred in 3 (4.6%) patients in the apixaban group and 13 (20%) patients in the placebo group (HR: 0.27; 95% CI: 0.13-0.54; p = 0.0002).,"[{'ForeName': 'Danyal', 'Initials': 'D', 'LastName': 'Ladha', 'Affiliation': 'Department of Medicine, Ottawa Hospital Research Institute at the University of Ottawa, Ontario, Canada.'}, {'ForeName': 'Ranjeeta', 'Initials': 'R', 'LastName': 'Mallick', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Tzu-Fei', 'Initials': 'TF', 'LastName': 'Wang', 'Affiliation': 'Department of Medicine, Ottawa Hospital Research Institute at the University of Ottawa, Ontario, Canada; Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Caiano', 'Affiliation': 'Department of Medicine and Surgery, University of Insubria, Varese, Italy.'}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Wells', 'Affiliation': 'Department of Medicine, Ottawa Hospital Research Institute at the University of Ottawa, Ontario, Canada; Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Carrier', 'Affiliation': 'Department of Medicine, Ottawa Hospital Research Institute at the University of Ottawa, Ontario, Canada; Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada. Electronic address: mcarrier@toh.ca.'}]",Thrombosis research,['10.1016/j.thromres.2021.03.013'] 3952,33857782,"N95 respirator reuse, decontamination methods, and microbial burden: A randomized controlled trial.","PURPOSE To evaluate the effectiveness and ease of N95 respirator decontamination methods in a clinic setting and to identify the extent of microbial colonization on respirators associated with reuse. METHODS In a prospective fashion, N95 respirators (n = 15) were randomized to a decontamination process (time, dry heat, or ultraviolet C light [UVC]) in outpatient clinics. Each respirator was re-used up to 5 separate clinic sessions. Swabs on each respirator for SARS-CoV-2, bacteria, and fungi were obtained before clinic, after clinic and post-treatment. Mask integrity was checked after each treatment (n = 68). Statistical analyses were performed to determine factors for positive samples. RESULTS All three decontamination processes reduced bacteria counts similarly. On multivariate mixed model analysis, there were an additional 8.1 colonies of bacteria (95% CI 5.7 to 10.5; p < 0.01) on the inside compared to the outside surface of the respirators. Treatment resulted in a decrease of bacterial load by 8.6 colonies (95% CI -11.6 to -5.5; p < 0.01). Although no decontamination treatment affected the respirator filtration efficiency, heat treatments were associated with the breakdown of thermoplastic elastomer straps. Contamination with fungal and SARS-CoV-2 viral particles were minimal to non-existent. CONCLUSIONS Time, heat and UVC all reduced bacterial load on reused N95 respirators. Fungal contamination was minimal. Heat could permanently damage some elastic straps making the respirators nonfunctional. Given its effectiveness against microbes, lack of damage to re-treated respirators and logistical ease, UVC represents an optimal decontamination method for individual N95 respirators when reuse is necessary.",2021,"Although no decontamination treatment affected the respirator filtration efficiency, heat treatments were associated with the breakdown of thermoplastic elastomer straps.",['N95 respirators (n\xa0=\xa015'],"['decontamination process (time, dry heat, or ultraviolet C light [UVC', 'N95 respirator decontamination methods']","['Mask integrity', 'bacterial load', 'respirator filtration efficiency', 'N95 respirator reuse, decontamination methods, and microbial burden']","[{'cui': 'C0429406', 'cui_str': 'Pattern ERG N95'}, {'cui': 'C0035208', 'cui_str': 'Air-purifying respirator'}]","[{'cui': 'C0011121', 'cui_str': 'Decontamination'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C1532472', 'cui_str': 'Ultra-violet'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0429406', 'cui_str': 'Pattern ERG N95'}, {'cui': 'C0035208', 'cui_str': 'Air-purifying respirator'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C2936404', 'cui_str': 'Bacterial Load'}, {'cui': 'C0035208', 'cui_str': 'Air-purifying respirator'}, {'cui': 'C0016107', 'cui_str': 'Filtration'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0429406', 'cui_str': 'Pattern ERG N95'}, {'cui': 'C0011121', 'cui_str': 'Decontamination'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",15.0,0.0530428,"Although no decontamination treatment affected the respirator filtration efficiency, heat treatments were associated with the breakdown of thermoplastic elastomer straps.","[{'ForeName': 'Zi Yang', 'Initials': 'ZY', 'LastName': 'Jiang', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, McGovern Medical School, Houston, TX, USA.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, McGovern Medical School, Houston, TX, USA.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Schmale', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Brown', 'Affiliation': 'Department of Epidemiology, Human Genetics and Environmental Sciences, The University of Texas School of Public Health, Houston, TX, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Lorenz', 'Affiliation': 'Department of Microbiology and Molecular Genetics, McGovern Medical School, The University of Texas Health Science Center, Houston, TX, USA.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Patlovich', 'Affiliation': 'Office of Safety, Health Environment, and Risk Management, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Karan', 'Initials': 'K', 'LastName': 'Goswami', 'Affiliation': 'Rothman Orthopaedic Institute at Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Hannah B', 'Initials': 'HB', 'LastName': 'Wilson', 'Affiliation': 'Department of Microbiology and Molecular Genetics, McGovern Medical School, The University of Texas Health Science Center, Houston, TX, USA.'}, {'ForeName': 'Jumah', 'Initials': 'J', 'LastName': 'Ahmad', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, McGovern Medical School, Houston, TX, USA.'}, {'ForeName': 'Ronda', 'Initials': 'R', 'LastName': 'Alexander', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, McGovern Medical School, Houston, TX, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Bryan', 'Affiliation': 'Office of Safety, Health Environment, and Risk Management, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Burke', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, McGovern Medical School, Houston, TX, USA.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Citardi', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, McGovern Medical School, Houston, TX, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Elias', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, McGovern Medical School, Houston, TX, USA.'}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Ho', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, McGovern Medical School, Houston, TX, USA.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Jacob', 'Affiliation': 'Office of Safety, Health Environment, and Risk Management, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Garren', 'Initials': 'G', 'LastName': 'Low', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, McGovern Medical School, Houston, TX, USA.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Miramón', 'Affiliation': 'Department of Microbiology and Molecular Genetics, McGovern Medical School, The University of Texas Health Science Center, Houston, TX, USA.'}, {'ForeName': 'Aniruddha U', 'Initials': 'AU', 'LastName': 'Patki', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, McGovern Medical School, Houston, TX, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Yao', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, McGovern Medical School, Houston, TX, USA.'}, {'ForeName': 'Amber U', 'Initials': 'AU', 'LastName': 'Luong', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, McGovern Medical School, Houston, TX, USA; Center for Immunology and Autoimmune Diseases, Institute of Molecular Medicine, McGovern Medical School at The University of Texas Health Science Center, Houston, TX, USA. Electronic address: amber.u.luong@uth.tmc.edu.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2021.103017'] 3953,33857750,Effect of citalopram on hippocampal volume in first-episode schizophrenia: Structural MRI results from the DECIFER trial.,"Hippocampal volume loss is prominent in first episode schizophrenia (FES) and has been associated with poor clinical outcomes and with BDNF genotype; antidepressants are believed to reverse hippocampal volume loss via release of BDNF. In a 12-month, placebo-controlled add-on trial of the antidepressant, citalopram, during the maintenance phase of FES, negative symptoms were improved with citalopram. We now report results of structural brain imaging at baseline and 6 months in 63 FES patients (34 in citalopram group) from the trial to assess whether protection against hippocampal volume loss contributed to improved negative symptoms with citalopram. Hippocampal volumetric integrity (HVI) did not change significantly in the citalopram or placebo group and did not differ between treatment groups, whereas citalopram was associated with greater volume loss of the right CA1 subfield. Change in cortical thickness was associated with SANS change in 4 regions (left rostral anterior cingulate, right frontal pole, right cuneus, and right transverse temporal) but none differed between treatment groups. Our findings suggest that minimal hippocampal volume loss occurs after stabilization on antipsychotic treatment and that citalopram's potential benefit for negative symptoms is unlikely to result from protection against hippocampal volume loss or cortical thinning.",2021,"Hippocampal volumetric integrity (HVI) did not change significantly in the citalopram or placebo group and did not differ between treatment groups, whereas citalopram was associated with greater volume loss of the right CA1 subfield.","['63 FES patients (34 in citalopram group', 'first-episode schizophrenia']","['placebo', 'citalopram', 'antidepressant, citalopram']","['hippocampal volume', 'Change in cortical thickness', 'Hippocampal volumetric integrity (HVI']","[{'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008845', 'cui_str': 'Citalopram'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008845', 'cui_str': 'Citalopram'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}]","[{'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0205266', 'cui_str': 'Intact'}]",63.0,0.0564656,"Hippocampal volumetric integrity (HVI) did not change significantly in the citalopram or placebo group and did not differ between treatment groups, whereas citalopram was associated with greater volume loss of the right CA1 subfield.","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Qi', 'Affiliation': 'Department of Psychiatry, NYU Langone Health, 1 Park Avenue, New York, NY 10016, United States of America.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Blessing', 'Affiliation': 'Department of Psychiatry, NYU Langone Health, 1 Park Avenue, New York, NY 10016, United States of America.'}, {'ForeName': 'Chenxiang', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Division of Biostatistics, Department of Population Health, NYU School of Medicine, 180 Madison Avenue, New York, NY 10016, United States of America.'}, {'ForeName': 'Babak A', 'Initials': 'BA', 'LastName': 'Ardekani', 'Affiliation': 'Department of Psychiatry, NYU Langone Health, 1 Park Avenue, New York, NY 10016, United States of America; Nathan Kline Institute for Psychiatric Research, 140 Old Orangeburg Road, Orangeburg, NY 10962, United States of America.'}, {'ForeName': 'Kamber L', 'Initials': 'KL', 'LastName': 'Hart', 'Affiliation': 'Department of Psychiatry, NYU Langone Health, 1 Park Avenue, New York, NY 10016, United States of America.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Marx', 'Affiliation': 'Department of Psychiatry, NYU Langone Health, 1 Park Avenue, New York, NY 10016, United States of America.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Freudenreich', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, 55 Fruit Street, Boston, MA 02114, United States of America.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Cather', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, 55 Fruit Street, Boston, MA 02114, United States of America.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Holt', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, 55 Fruit Street, Boston, MA 02114, United States of America.'}, {'ForeName': 'Iruma', 'Initials': 'I', 'LastName': 'Bello', 'Affiliation': 'New York State Psychiatric Institute, Columbia University Medical Center, 601 West 168th St., New York, NY 10032, United States of America; Columbia University Vagelos College of Physicians and Surgeons, 1051 Riverside Drive, New York, NY 10032, United States of America.'}, {'ForeName': 'Erica D', 'Initials': 'ED', 'LastName': 'Diminich', 'Affiliation': 'Program in Public Health, Department of Family, Population, and Preventive Medicine, Stony Brook School of Medicine, Health Sciences Center, Stony Brook, NY 11794, United States of America.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, 600 Wanping S Road, Shanghai, China, 200030.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Worthington', 'Affiliation': 'Department of Psychiatry, NYU Langone Health, 1 Park Avenue, New York, NY 10016, United States of America.'}, {'ForeName': 'Botao', 'Initials': 'B', 'LastName': 'Zeng', 'Affiliation': 'Department of Psychiatry, Qingdao Mental Health Center, 9 Dongguan Road, Qingdao, Shandong, China, 266034.'}, {'ForeName': 'Renrong', 'Initials': 'R', 'LastName': 'Wu', 'Affiliation': 'National Clinical Research Center for Mental Disorders, Mental Health Institute, The Second Xiangya Hospital of Central South University, 139 Renmin Middle Road, Changsha, Hunan, China, 410005.'}, {'ForeName': 'Xiaoduo', 'Initials': 'X', 'LastName': 'Fan', 'Affiliation': 'Department of Psychiatry, UMass Memorial Healthcare/University of Massachusetts Medical School, 365 Plantation Street, Worcester, MA 01605, United States of America.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Troxel', 'Affiliation': 'Division of Biostatistics, Department of Population Health, NYU School of Medicine, 180 Madison Avenue, New York, NY 10016, United States of America.'}, {'ForeName': 'Jingping', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'National Clinical Research Center for Mental Disorders, Mental Health Institute, The Second Xiangya Hospital of Central South University, 139 Renmin Middle Road, Changsha, Hunan, China, 410005.'}, {'ForeName': 'Jijun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, 600 Wanping S Road, Shanghai, China, 200030.'}, {'ForeName': 'Donald C', 'Initials': 'DC', 'LastName': 'Goff', 'Affiliation': 'Department of Psychiatry, NYU Langone Health, 1 Park Avenue, New York, NY 10016, United States of America; Nathan Kline Institute for Psychiatric Research, 140 Old Orangeburg Road, Orangeburg, NY 10962, United States of America. Electronic address: Donald.Goff@nyulangone.org.'}]",Psychiatry research. Neuroimaging,['10.1016/j.pscychresns.2021.111286'] 3954,33857681,Recruitment and enrollment of participants in an online diabetes self-management intervention in a virtual environment.,"Effective recruitment of research participants is essential for successful randomized controlled trials and remains one of the most challenging and labor-intensive aspects of conducting research. The purpose of this manuscript is to describe recruitment methods for this two-group, internet-based intervention trial and enrollment status in relation to recruitment methods, accounting for accrual rates and recruitment costs and to discuss our recruitment results and limitations informed by the Clinical Trials Transformation Initiative (CTTI) team's evidence and expert-based recommendations for recruitment. The primary study was a two-group randomized controlled trial designed to evaluate the efficacy of a virtual environment, Diabetes LIVE©, compared to a traditional website format to provide diabetes self-management education and support to adults with type 2 diabetes. Our recruitment experience was labor-intensive, multimodal, and required multiple iterations throughout the study to meet recruitment goals. To allow for more efficient and realistic budgets aligned with funding, researchers should engage stakeholders in recruitment planning and monitor and report personnel time and cost by recruitment methods. To allow for more efficient and effective recruitment into meaningful clinical trials and of interest to participants, researchers should use a participative approach during all study phases, including question development.",2021,"The primary study was a two-group randomized controlled trial designed to evaluate the efficacy of a virtual environment, Diabetes LIVE©, compared to a traditional website format to provide diabetes self-management education and support to adults with type 2 diabetes.",['adults with type 2 diabetes'],"['online diabetes self-management intervention', 'virtual environment, Diabetes LIVE©, compared to a traditional website format to provide diabetes self-management education']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",[],,0.240003,"The primary study was a two-group randomized controlled trial designed to evaluate the efficacy of a virtual environment, Diabetes LIVE©, compared to a traditional website format to provide diabetes self-management education and support to adults with type 2 diabetes.","[{'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Vorderstrasse', 'Affiliation': 'Duke University School of Nursing, DUMC 3322, 307 Trent Drive, Durham, NC 27710I, USA; College of Nursing, University of Massachusetts Amherst, 651 North Pleasant Street, Amherst, MA 01003-9299, USA.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Reagan', 'Affiliation': 'New York University Rory Meyers College of Nursing, 433 1st Avenue, New York, NY 10010, USA; University of Connecticut School of Nursing, 231 Glenbrook Rd., Unit 4026, Storrs, CT 06269-3237, USA. Electronic address: louise.reagan@uconn.edu.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': ""D'Eramo Melkus"", 'Affiliation': 'New York University Rory Meyers College of Nursing, 433 1st Avenue, New York, NY 10010, USA.'}, {'ForeName': 'Sarah Y', 'Initials': 'SY', 'LastName': 'Nowlin', 'Affiliation': 'New York University Rory Meyers College of Nursing, 433 1st Avenue, New York, NY 10010, USA.'}, {'ForeName': 'Stacia B', 'Initials': 'SB', 'LastName': 'Birdsall', 'Affiliation': 'New York University Rory Meyers College of Nursing, 433 1st Avenue, New York, NY 10010, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Burd', 'Affiliation': 'Duke University School of Nursing, DUMC 3322, 307 Trent Drive, Durham, NC 27710I, USA.'}, {'ForeName': 'Yoon Hee', 'Initials': 'YH', 'LastName': 'Cho', 'Affiliation': 'New York University Rory Meyers College of Nursing, 433 1st Avenue, New York, NY 10010, USA.'}, {'ForeName': 'Jang', 'Initials': 'J', 'LastName': 'Myoungock', 'Affiliation': 'Duke University School of Nursing, DUMC 3322, 307 Trent Drive, Durham, NC 27710I, USA; College of Nursing, Chungnam National University, Daejeon, South Korea.'}, {'ForeName': 'Johnson', 'Initials': 'J', 'LastName': 'Constance', 'Affiliation': 'Duke University School of Nursing, DUMC 3322, 307 Trent Drive, Durham, NC 27710I, USA; Jane and Robert Cizik School of Nursing, The University of Texas Health Science Center at Houston, School of Biomedical Informatics, 6901 Bertner Ave. SON-539D, Houston, TX 77030, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106399'] 3955,33857680,Efficacy of mindfulness-based relapse prevention in veterans with substance use disorders: Design and methodology of a randomized clinical trial.,"Mindfulness based interventions have been shown to be efficacious in treating depression, anxiety, pain and substance use disorders (SUDs). Mindfulness-Based Relapse Prevention (MBRP) is an intervention that integrates cognitive-behavioral relapse prevention and mindfulness meditation practices, in an 8-week, manualized group intervention designed to treat SUDs by helping patients regulate negative emotional states and reactive behavior. This paper describes the rationale, study design and methodology of a two-site, randomized controlled trial comparing MBRP to 12-Step Facilitation (TSF) in military Veterans following completion of intensive outpatient treatment for SUDs. The 8 weeks of 90-min, group-based MBRP or TSF sessions are followed by 3-, 6- and 10-month follow-up period with assessments of alcohol/drug use, quality of life, depression, anxiety, mindfulness and other functional outcomes, such as employment. The primary hypothesis is that MBRP will be significantly better than TSF in promoting recovery and prevention of relapse to substance use in a military Veteran population. The secondary hypothesis is that MBRP will lead to greater improvements in quality of life, depression/anxiety, and functional outcomes, such as employment. This study is designed to provide information about the use of group-based MBRP as a relapse prevention strategy for military Veterans who have completed an intensive SUD clinical treatment program. Clinical Trial Identifier: NCT02326363.",2021,"Mindfulness-Based Relapse Prevention (MBRP) is an intervention that integrates cognitive-behavioral relapse prevention and mindfulness meditation practices, in an 8-week, manualized group intervention designed to treat SUDs by helping patients regulate negative emotional states and reactive behavior.","['military Veterans who have completed an intensive SUD clinical treatment program', 'military Veterans following completion of intensive outpatient treatment for SUDs', 'veterans with substance use disorders']","['TSF', 'MBRP', 'Mindfulness-Based Relapse Prevention (MBRP', 'mindfulness-based relapse prevention', 'MBRP to 12-Step Facilitation (TSF']","['quality of life, depression, anxiety, mindfulness and other functional outcomes, such as employment', 'quality of life, depression/anxiety, and functional outcomes']","[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}]","[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0679867', 'cui_str': 'Relapse prevention'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0014003', 'cui_str': 'Employment'}]",,0.0697736,"Mindfulness-Based Relapse Prevention (MBRP) is an intervention that integrates cognitive-behavioral relapse prevention and mindfulness meditation practices, in an 8-week, manualized group intervention designed to treat SUDs by helping patients regulate negative emotional states and reactive behavior.","[{'ForeName': 'Kathleen T', 'Initials': 'KT', 'LastName': 'Brady', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, United States of America; Ralph H Johnson Veterans Administration Medical Center, Charleston, SC, United States of America. Electronic address: bradyk@musc.edu.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Killeen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, United States of America; Ralph H Johnson Veterans Administration Medical Center, Charleston, SC, United States of America. Electronic address: killeent@musc.edu.'}, {'ForeName': 'Nathaniel L', 'Initials': 'NL', 'LastName': 'Baker', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, United States of America. Electronic address: bakern@musc.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106393'] 3956,33857678,"Estimating the financial costs associated with a phase III, multi-site exercise intervention trial: Investigating gains in neurocognition in an intervention trial of exercise (IGNITE).","INTRODUCTION Supervised exercise interventions are expensive and time intensive. However, there are financial costs to consider in addition to the intervention itself, namely: advertising and recruitment, outcome assessments, and other trial-related costs. OBJECTIVES In this analysis, we examine the financial costs associated with the administration of Investigating Gains in Neurocognition in an Intervention Trial of Exercise (IGNITE) to quantify the costs associated with large exercise intervention trials and to provide future investigators with financial estimates if they wish to pursue studies of a similar design. METHODS Cost per randomized participant were calculated in four areas: (1) advertising and recruitment, (2) outcome assessments, (3) delivery of the intervention, and (4) other trial-related expenses. Overall trial costs associated with data analysis, faculty salaries, and indirect costs were estimated as well. RESULTS The total cost per randomized participant was estimated to be $16,494. Outcome assessments accounted for the highest proportion of per-participant (75%) and total trial (38%) costs. Neuroimaging assessments (MRI & PET) cost $8247 per randomized participant, accounting for two-thirds (67%) of outcome assessment costs and half (50%) of per-participant costs. CONCLUSION Large clinical trials of exercise are expensive (~$21 million), particularly when administering several visits to assess study aims. Outcome assessments, specifically those involving neuroimaging, accounted for a significant proportion of total costs in this analysis. Future investigators must budget accordingly if they wish to conduct a comprehensive, multi-site exercise intervention trial that examines numerous physiological and psychological outcomes.",2021,Outcome assessments accounted for the highest proportion of per-participant (75%) and total trial (38%) costs.,[],['Supervised exercise interventions'],"['Overall trial costs associated with data analysis, faculty salaries, and indirect costs', 'total costs', 'Neuroimaging assessments (MRI & PET) cost']",[],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0036064', 'cui_str': 'Salaries'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}]",,0.158711,Outcome assessments accounted for the highest proportion of per-participant (75%) and total trial (38%) costs.,"[{'ForeName': 'Patrick T', 'Initials': 'PT', 'LastName': 'Donahue', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA, USA; Johns Hopkins University, Baltimore, MD, USA. Electronic address: ptd3@pitt.edu.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Grove', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Stillman', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Chaeryon', 'Initials': 'C', 'LastName': 'Kang', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Burns', 'Affiliation': 'University of Kansas Medical Center, Kansas City, MO, USA.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Hillman', 'Affiliation': 'Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Arthur F', 'Initials': 'AF', 'LastName': 'Kramer', 'Affiliation': 'Northeastern University, Boston, MA, USA; University of Illinois, Champaign, IL, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'McAuley', 'Affiliation': 'University of Illinois, Champaign, IL, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vidoni', 'Affiliation': 'University of Kansas Medical Center, Kansas City, MO, USA.'}, {'ForeName': 'Kirk I', 'Initials': 'KI', 'LastName': 'Erickson', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA, USA. Electronic address: kiericks@pitt.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106401'] 3957,33857664,Randomized double-blind sham-controlled trial of thalamic versus GPi stimulation in patients with severe medically refractory Gilles de la Tourette Syndrome.,"BACKGROUND There are still no sufficient data regarding the use of deep brain stimulation (DBS) in Gilles de la Tourette syndrome (GTS) and no agreement on optimal target. OBJECTIVE To compare efficacy and safety of bilateral DBS of thalamus (centromedian-ventro-oral internus, CM-Voi) versus posteroventral lateral globus pallidus internus (pvl GPi)) versus sham stimulation, and baseline in severe medically refractory GTS. METHODS In this randomized double-blind sham stimulation-controlled trial (RCT), 10 patients (3 women, mean age=29.4+10.2 SD, range 18-47) underwent three blinded periods each lasting three months including (i) sham, (ii) pvl GPi (on-GPi), and (iii) thalamic stimulation (on-thal) followed by an open uncontrolled long-term follow-up (up to 9 years) with individually determined target and stimulation settings. RESULTS Nine patients completed the RCT. At group level, on-GPi - but not on-thal - resulted in a significant tic reduction compared to baseline, but had no effect on premonitory urges and psychiatric comorbidities. Direct comparisons of targets resulted in inconsistent or negative (compared to sham) findings. During follow-up, we found no improvement of tics, comorbidities, and quality of life at group level, however, single patients benefitted continuously from thalamic DBS. At last follow-up 89.9 months (mean) after surgery, 50% of patients had discontinued DBS. Hardware infections occurred in 3/10 patients. CONCLUSION Our data suggest that the initial effect of pvl GPi DBS is superior to thalamic (CM-Voi) DBS. While half of the patients discontinued treatment, single patients benefitted from thalamic DBS even after years. It is likely that outcome is influenced by various factors beyond the mere change in tic severity.",2021,"During follow-up, we found no improvement of tics, comorbidities, and quality of life at group level, however, single patients benefitted continuously from thalamic DBS.","['severe medically refractory GTS', '10 patients (3 women, mean age=29.4+10.2 SD, range 18-47', 'patients with severe medically refractory Gilles de la Tourette Syndrome']","['pvl GPi (on-GPi), and (iii) thalamic stimulation (on-thal) followed by an open uncontrolled long-term follow-up (up to 9 years) with individually determined target and stimulation settings', 'thalamic versus GPi stimulation', 'bilateral DBS of thalamus (centromedian-ventro-oral internus, CM-Voi) versus posteroventral lateral globus pallidus internus (pvl GPi', 'pvl GPi DBS']","['tics, comorbidities, and quality of life', 'Hardware infections', 'premonitory urges and psychiatric comorbidities']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0040517', 'cui_str': ""Gilles de la Tourette's syndrome""}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0023529', 'cui_str': 'Periventricular leukomalacia'}, {'cui': 'C0017759', 'cui_str': 'Glucose-6-phosphate isomerase'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}]","[{'cui': 'C0040188', 'cui_str': 'Tic disorder'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}]",,0.399217,"During follow-up, we found no improvement of tics, comorbidities, and quality of life at group level, however, single patients benefitted continuously from thalamic DBS.","[{'ForeName': 'K R', 'Initials': 'KR', 'LastName': 'Müller-Vahl', 'Affiliation': 'Clinic of Psychiatry, Socialpsychiatry and Psychotherapy, Hannover Medical School, Germany. Electronic address: mueller-vahl.kirsten@mh-hannover.de.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Szejko', 'Affiliation': 'Clinic of Psychiatry, Socialpsychiatry and Psychotherapy, Hannover Medical School, Germany; Department of Neurology, Medical University of Warsaw, Poland; Department of Neurology, Yale School of Medicine, New Haven, the USA; Department of Bioethics, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Saryyeva', 'Affiliation': 'Department of Neurosurgery, Hannover Medical School, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Schrader', 'Affiliation': 'Department of Neurology, Hannover Medical School, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Krueger', 'Affiliation': 'Clinic of Psychiatry, Socialpsychiatry and Psychotherapy, Hannover Medical School, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Horn', 'Affiliation': 'Department of Neurology, Movement Disorders and Neuromodulation Unit, Campus Charite Mitte, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Kühn', 'Affiliation': 'Department of Neurology, Movement Disorders and Neuromodulation Unit, Campus Charite Mitte, Charité - Universitätsmedizin Berlin, Berlin, Germany; Berlin School of Mind and Brain, Charité - Universitätsmedizin Berlin, Germany, Berlin; NeuroCure, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Krauss', 'Affiliation': 'Department of Neurosurgery, Hannover Medical School, Germany.'}]",Brain stimulation,['10.1016/j.brs.2021.04.004'] 3958,33857594,"Nasal irrigation with Glycyrrhiza glabra extract for treatment of allergic rhinitis - A study of in vitro, in vivo and clinical trial.","ETHNOPHARMACOLOGICAL RELEVANCE Glycyrrhiza glabra, a family of licorice and a traditional Chinese medicine with sweet taste and favorable smell, has anti-inflammatory, anti-allergic and immunomodulatory functions. AIM OF THE STUDY We developed a licorice extract (LE) by using glycyrrhiza glabra and administered it through nasal irrigation to treat allergic rhinitis (AR). MATERIALS AND METHODS LE was prepared into extract powder, and the anti-inflammatory effect of the LE was evaluated by calcium ionophore-induced activated mast cell model (in vitro). Then, local passive anaphylaxis assays were applied to investigate the anti-IgE-mediated allergic reaction of the LE in mice (in vivo). A developed LE was administered through nasal irrigation to treat AR in clinic settings. A total of 60 participants diagnosed with AR were included in this clinical trial; they were randomly assigned to three interventions: licorice nasal irrigation (LNI), corticosteroid nasal irrigation (CNI), and saline nasal irrigation (SNI). They performed nasal irrigation once a day for 1 month. Both subjective questionnaires (22-item Sino-Nasal Outcome Test [SNOT-22] and visual analog scale [VAS]) and objective examinations (acoustic rhinometry and nasal endoscopy) were used for effectiveness assessments. RESULTS All three interventions could improve SNOT-22 scores, but the effects of LNI and CNI were more significant. According to VAS scores for nasal blockage, rhinorrhea, sneezing, nasal pruritus, postnasal discharge, and olfactory disturbance, the effect of LNI was superior to those of CNI and SNI. The results of rhinometry revealed that LNI significantly improved nasal resistance. Endoscopic analysis showed that both LNI and CNI, but not SNI, could significantly improve turbinate hypertrophy. Moreover, the best procedural comfort was found for LNI, which had no side effects or complications during the trial. CONCLUSIONS LNI is a natural, safe, and innovative therapy that can effectively treat AR. Its effect is superior to those of CNI and SNI, and it has greatly improved procedural comfort.",2021,"RESULTS All three interventions could improve SNOT-22 scores, but the effects of LNI and CNI were more significant.",['60 participants diagnosed with AR'],"['LE', 'licorice extract (LE) by using glycyrrhiza glabra and administered it through nasal irrigation', 'Glycyrrhiza glabra extract', 'licorice nasal irrigation (LNI), corticosteroid nasal irrigation (CNI), and saline nasal irrigation (SNI']","['SNOT-22 scores', 'subjective questionnaires (22-item Sino-Nasal Outcome Test [SNOT-22] and visual analog scale [VAS]) and objective examinations (acoustic rhinometry and nasal endoscopy', 'turbinate hypertrophy', 'VAS scores for nasal blockage, rhinorrhea, sneezing, nasal pruritus, postnasal discharge, and olfactory disturbance, the effect of LNI', 'nasal resistance']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}]","[{'cui': 'C2756786', 'cui_str': 'Glycyrrhiza glabra extract'}, {'cui': 'C0697105', 'cui_str': 'Glycyrrhiza glabra'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C2350442', 'cui_str': 'Nasal irrigation'}, {'cui': 'C0017987', 'cui_str': 'Licorice'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C5197690', 'cui_str': 'SNOT-22'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C5197689', 'cui_str': 'Sinonasal Outcome Test'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0430619', 'cui_str': 'Acoustic rhinometry'}, {'cui': 'C0189024', 'cui_str': 'Endoscopy of nose'}, {'cui': 'C1266928', 'cui_str': 'Nasal turbinate bone structure'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C0037383', 'cui_str': 'Sneezing'}, {'cui': 'C0850060', 'cui_str': 'Nasal pruritus'}, {'cui': 'C0032781', 'cui_str': 'Posterior rhinorrhea'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0017987', 'cui_str': 'Licorice'}, {'cui': 'C2350442', 'cui_str': 'Nasal irrigation'}, {'cui': 'C0429208', 'cui_str': 'Nasal resistance'}]",60.0,0.0213513,"RESULTS All three interventions could improve SNOT-22 scores, but the effects of LNI and CNI were more significant.","[{'ForeName': 'Geng-He', 'Initials': 'GH', 'LastName': 'Chang', 'Affiliation': 'Department of Otolaryngology, Chang Gung Memorial Hospital, Chiayi, Taiwan; Graduate Institute of Clinical Medical Sciences, College of Medicine, Chang Gung University, Taiwan; Health Information and Epidemiology Laboratory of Chang Gung Memorial Hospital, Chia-Yi 61363, Taiwan; Faculty of Medicine, College of Medicine, Chang Gung University, Taoyuan, Taiwan. Electronic address: genghechang@gmail.com.'}, {'ForeName': 'Yu-Shih', 'Initials': 'YS', 'LastName': 'Lin', 'Affiliation': 'Department of Pharmacy, Chiayi Chang Gung Memorial Hospital, Chiayi, Taiwan. Electronic address: yohimba@cgmh.org.tw.'}, {'ForeName': 'Ke-Hsin', 'Initials': 'KH', 'LastName': 'Hsu', 'Affiliation': 'Department of Otolaryngology, Chang Gung Memorial Hospital, Chiayi, Taiwan. Electronic address: a2828282828a@gmail.com.'}, {'ForeName': 'Yu-Ching', 'Initials': 'YC', 'LastName': 'Cheng', 'Affiliation': 'Department of Otolaryngology, Chang Gung Memorial Hospital, Chiayi, Taiwan. Electronic address: a8890927@gmail.com.'}, {'ForeName': 'Pei-Rung', 'Initials': 'PR', 'LastName': 'Yang', 'Affiliation': 'Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital, Chiayi, Taiwan; School of Traditional Chinese Medicine, College of Medicine, Chang Gung University, Taoyuan, Taiwan. Electronic address: u9302702@cmu.edu.tw.'}, {'ForeName': 'Ming-Shao', 'Initials': 'MS', 'LastName': 'Tsai', 'Affiliation': 'Department of Otolaryngology, Chang Gung Memorial Hospital, Chiayi, Taiwan; Graduate Institute of Clinical Medical Sciences, College of Medicine, Chang Gung University, Taiwan; Health Information and Epidemiology Laboratory of Chang Gung Memorial Hospital, Chia-Yi 61363, Taiwan; Faculty of Medicine, College of Medicine, Chang Gung University, Taoyuan, Taiwan. Electronic address: b87401061@cgmh.org.tw.'}, {'ForeName': 'Yao-Te', 'Initials': 'YT', 'LastName': 'Tsai', 'Affiliation': 'Department of Otolaryngology, Chang Gung Memorial Hospital, Chiayi, Taiwan. Electronic address: yaote1215@gmail.com.'}, {'ForeName': 'Cheng-Ming', 'Initials': 'CM', 'LastName': 'Hsu', 'Affiliation': 'Department of Otolaryngology, Chang Gung Memorial Hospital, Chiayi, Taiwan; Faculty of Medicine, College of Medicine, Chang Gung University, Taoyuan, Taiwan. Electronic address: scm00031@gmail.com.'}, {'ForeName': 'Pey-Jium', 'Initials': 'PJ', 'LastName': 'Chang', 'Affiliation': 'Graduate Institute of Clinical Medical Sciences, College of Medicine, Chang Gung University, Taiwan. Electronic address: peyjiumc@mail.cgu.edu.tw.'}, {'ForeName': 'Chung-Sheng', 'Initials': 'CS', 'LastName': 'Shi', 'Affiliation': 'Graduate Institute of Clinical Medical Sciences, College of Medicine, Chang Gung University, Taiwan. Electronic address: csshi@mail.cgu.edu.tw.'}, {'ForeName': 'Yao-Hsu', 'Initials': 'YH', 'LastName': 'Yang', 'Affiliation': 'Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital, Chiayi, Taiwan; School of Traditional Chinese Medicine, College of Medicine, Chang Gung University, Taoyuan, Taiwan. Electronic address: r95841012@ntu.edu.tw.'}, {'ForeName': 'Ching-Yuan', 'Initials': 'CY', 'LastName': 'Wu', 'Affiliation': 'Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital, Chiayi, Taiwan; School of Traditional Chinese Medicine, College of Medicine, Chang Gung University, Taoyuan, Taiwan. Electronic address: chingyuanwumd@gmail.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2021.114116'] 3959,33857496,A Tale of Two Centrifugal Flow Ventricular Assist Devices as Bridge to Heart Transplant.,"BACKGROUND Use of continuous flow left ventricular assist devices (CFVAD) has previously increased over the years as bridge to transplant (BTT). The Heartware HVAD and HeartMate III (HM3) are currently approved centrifugal flow devices used for BTT. We sought to evaluate outcomes of the patients listed and transplanted after receiving these two devices. METHODS The United Network of Organ Sharing (UNOS) thoracic transplant database was queried after August 23, 2017 till December 2018 to identify patients aged > 18 years listed for HTx and supported by either HVAD or HM3. Patient characteristics were evaluated at time of listing and transplant. Primary study end point was 1-year mortality after LVAD implantation. Non-parametric tests were used to evaluate the device groups. RESULTS There were 569 patients listed for HTx during the study period of which 226 had HM3 and 343 HVAD. The HM3 group had more men (82% v. 74%, p=0.02), diabetics (38% v. 29%, p=0.02) and had a higher BMI (28 vs. 27, p=0.04) at listing. Between HM3 and HVAD groups, the 1-year mortality was 20% v. 17% respectively (log-rank p=0.28, Figure 1). The post-transplant survival at 1-year was 97% and 94% respectively for the HM3 and HVAD groups (p=0.1). CONCLUSIONS In relatively well-matched group of patients listed for heart transplant with a centrifugal flow LVAD the 6 month and 1-year mortality on the waitlist as well as post transplant were not statistically different. Additional real-world experience or a randomized trial would be needed to determine if one is superior.",2021,"The post-transplant survival at 1-year was 97% and 94% respectively for the HM3 and HVAD groups (p=0.1). ","['569 patients listed for HTx during the study period of which 226 had HM3 and 343 HVAD', '2017 till December 2018 to identify patients aged > 18 years listed for HTx and supported by either HVAD or HM3']",['continuous flow left ventricular assist devices'],"['higher BMI', '1-year mortality', 'diabetics', 'post-transplant survival', 'Heartware HVAD and HeartMate III']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1269815', 'cui_str': 'Patient identification'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439070', 'cui_str': 'III'}]",569.0,0.0358492,"The post-transplant survival at 1-year was 97% and 94% respectively for the HM3 and HVAD groups (p=0.1). ","[{'ForeName': 'Hazaim', 'Initials': 'H', 'LastName': 'Alwair', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, University of Louisville School of Medicine, Louisville, KY.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Whitehouse', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, University of Louisville School of Medicine, Louisville, KY.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Slaughter', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, University of Louisville School of Medicine, Louisville, KY.'}, {'ForeName': 'Jaimin R', 'Initials': 'JR', 'LastName': 'Trivedi', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, University of Louisville School of Medicine, Louisville, KY. Electronic address: jaimin.trivedi@louisville.edu.'}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2021.03.093'] 3960,33857466,Cerebral Oxygenation and Perfusion When Positioning Preterm Infants: Clinical Implications.,"OBJECTIVES To evaluate cerebral oxygenation (cTOI) and cerebral perfusion in preterm infants in supine versus prone positions. STUDY DESIGN Sixty preterm infants, born before 32 weeks gestation, were enrolled; 30 had bronchopulmonary dysplasia (BPD, defined as the need for respiratory support and/or supplemental oxygen at 36 weeks post menstrual age). Cerebral perfusion, cTOI and polysomnography was measured in both the supine and prone position with the initial position being randomized. Infants with a major intra-ventricular hemorrhage or major congenital abnormality were excluded. RESULTS Cerebral perfusion was unaffected by position or BPD status. In the BPD group, the mean cTOI was higher in the prone position as compared with the supine position by a difference of 3.27% (P = .03; 95% CI: 6.28 to 0.25) with no difference seen in the no-BPD group. For the BPD group, the burden of cerebral hypoxemia (cumulative time spent with cTOI < 55%) was significantly lower in the prone position (23%) compared with the supine position (29%) (p < 0.001). In those without BPD, position had no effect on cTOI. CONCLUSIONS In preterm infants with BPD, the prone position improved cerebral oxygenation and reduced cerebral hypoxemia. These findings may have implications for positioning practices. Further research will establish the impact of position on short and long-term developmental outcomes.",2021,"RESULTS Cerebral perfusion was unaffected by position or BPD status.","['preterm infants in supine versus prone positions', 'preterm infants with BPD', 'Infants with a major intra-ventricular hemorrhage or major congenital abnormality were excluded', 'Sixty preterm infants, born before 32 weeks gestation, were enrolled; 30 had bronchopulmonary dysplasia ']",[],"['cTOI', 'Cerebral Oxygenation and Perfusion', 'Cerebral perfusion, cTOI and polysomnography', 'cerebral oxygenation (cTOI) and cerebral perfusion', 'mean cTOI', 'cerebral oxygenation and reduced cerebral hypoxemia', 'burden of cerebral hypoxemia']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}]",[],"[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}]",60.0,0.055256,"RESULTS Cerebral perfusion was unaffected by position or BPD status.","[{'ForeName': 'Pranav R', 'Initials': 'PR', 'LastName': 'Jani', 'Affiliation': 'Westmead Hospital, Westmead, New South Wales; University of Sydney, Sydney, New South Wales. Electronic address: Pranav.Jani@health.nsw.gov.au.'}, {'ForeName': 'Krista', 'Initials': 'K', 'LastName': 'Lowe', 'Affiliation': 'Westmead Hospital, Westmead, New South Wales.'}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Perdomo', 'Affiliation': 'Westmead Hospital, Westmead, New South Wales.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Wakefield', 'Affiliation': 'Westmead Hospital, Westmead, New South Wales.'}, {'ForeName': 'Murray', 'Initials': 'M', 'LastName': 'Hinder', 'Affiliation': 'Westmead Hospital, Westmead, New South Wales; University of Sydney, Sydney, New South Wales.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Galea', 'Affiliation': ""University of Sydney, Sydney, New South Wales; The Children's Hospital at Westmead, Westmead, New South Wales; The Cerebral Palsy Alliance, Allambie Heights, New South Wales.""}, {'ForeName': 'Traci-Anne', 'Initials': 'TA', 'LastName': 'Goyen', 'Affiliation': 'Westmead Hospital, Westmead, New South Wales.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Halliday', 'Affiliation': ""University of Sydney, Sydney, New South Wales; The Children's Hospital at Westmead, Westmead, New South Wales.""}, {'ForeName': 'Karen Ann', 'Initials': 'KA', 'LastName': 'Waters', 'Affiliation': ""University of Sydney, Sydney, New South Wales; The Children's Hospital at Westmead, Westmead, New South Wales.""}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Badawi', 'Affiliation': ""University of Sydney, Sydney, New South Wales; The Children's Hospital at Westmead, Westmead, New South Wales; The Cerebral Palsy Alliance, Allambie Heights, New South Wales.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tracy', 'Affiliation': 'Westmead Hospital, Westmead, New South Wales; University of Sydney, Sydney, New South Wales.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2021.04.008'] 3961,33857455,Effect of alternative income assistance schedules on drug use and drug-related harm: a randomised controlled trial.,"BACKGROUND The synchronised monthly disbursement of income assistance, whereby all recipients are paid on the same day, has been associated with increases in illicit drug use and serious associated harms. This phenomenon is often referred to as the cheque effect. Because payment variability can affect consumption patterns, this study aimed to assess whether these harms could be mitigated through a structural intervention that varied income assistance payment timing and frequency. METHODS This randomised, parallel group trial was done in Vancouver, Canada, and enrolled recipients of income assistance whose drug use increased around payment days. The recipients were randomly assigned 1:2:2 to a control group that received monthly synchronised income assistance payments on government payment days, a staggered group in which participants received single desynchronised monthly income assistance payments, or a split and staggered group in which participants received desynchronised income assistance payments split into two instalments per month, 2 weeks apart, for six monthly payment cycles. Desynchronised payments in the intervention groups were made on individual payment days outside the week of the standard government schedules. Randomisation was through a pre-established stratified block procedure. Investigators and statisticians were masked to group allocation, but participants and front-line staff were not. Complete final results are reported after scheduled interim analyses and the resulting early stoppage of recruitment. Under intention-to-treat specifications, generalised linear mixed models were used to analyse the primary outcome, which was escalations in drug use, predefined as a 40% increase in at least one of: use frequency; use quantity; or number of substances used during the 3 days after government payments. Secondary analyses examined analogous drug use outcomes coinciding with individual payments as well as exposure to violence. This trial is registered with ClinicalTrials.gov, NCT02457949. FINDINGS Between Oct 27, 2015, and Jan 2, 2019, 45 participants were enrolled to the control group, 72 to the staggered group, and 77 to the split and staggered group. Intention-to-treat analyses showed a significantly reduced likelihood of increased drug use coinciding with government payment days, relative to the control group, in the staggered (adjusted odds ratio 0·38, 95% CI 0·20-0·74; p=0·0044) and split and staggered (0·44, 0·23-0·83; p=0·012) groups. Findings were consistent in the secondary analyses of drug use coinciding with individual payment days (staggered group 0·50, 0·27-0·96, p=0·036; split and staggered group 0·49, 0·26-0·94, p=0·030). However, secondary outcome analyses of exposure to violence showed increased harm in the staggered group compared with the control group (2·71, 1·06-6·91, p=0·037). Additionally, 51 individuals had a severe or life-threatening adverse event and there were six deaths, none of which was directly attributed to study participation. INTERPRETATION Complex results indicate the potential for modified income assistance payment schedules to mitigate escalations in drug use, provided measures to address unintended harms are also undertaken. Additional research is needed to clarify whether desynchronised schedules produce other unanticipated consequences and if additional measures could mitigate these harms. FUNDING Canadian Institutes of Health Research, Providence Health Care Research Institute, Peter Wall Institute for Advanced Research, Michael Smith Foundation for Health Research.",2021,"However, secondary outcome analyses of exposure to violence showed increased harm in the staggered group compared with the control group (2·71, 1·06-6·91, p=0·037).","['Between Oct 27, 2015, and Jan 2, 2019, 45 participants were enrolled to the control group, 72 to the staggered group, and 77 to the split and staggered group', 'Vancouver, Canada, and enrolled recipients of income assistance whose drug use increased around payment days']","['alternative income assistance schedules', 'control group that received monthly synchronised income assistance payments on government payment days, a staggered group in which participants received single desynchronised monthly income assistance payments, or a split and staggered group in which participants received desynchronised income assistance payments split']","['individual payments as well as exposure to violence', 'severe or life-threatening adverse event']","[{'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0344191', 'cui_str': 'Cerebellar decompression injury'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0220808', 'cui_str': 'Compensation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0220808', 'cui_str': 'Compensation'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0344191', 'cui_str': 'Cerebellar decompression injury'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0220808', 'cui_str': 'Compensation'}, {'cui': 'C0814549', 'cui_str': 'Violence Exposure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}]",45.0,0.145422,"However, secondary outcome analyses of exposure to violence showed increased harm in the staggered group compared with the control group (2·71, 1·06-6·91, p=0·037).","[{'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Richardson', 'Affiliation': 'Department of Sociology, University of British Columbia, Vancouver, BC, Canada; British Columbia Centre on Substance Use, Vancouver, BC, Canada. Electronic address: bccsu-lr@bccsu.ubc.ca.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Laing', 'Affiliation': 'Department of Sociology, University of British Columbia, Vancouver, BC, Canada; British Columbia Centre on Substance Use, Vancouver, BC, Canada.'}, {'ForeName': 'JinCheol', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'British Columbia Centre on Substance Use, Vancouver, BC, Canada.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Nosova', 'Affiliation': 'British Columbia Centre on Substance Use, Vancouver, BC, Canada.'}, {'ForeName': 'M-J', 'Initials': 'MJ', 'LastName': 'Milloy', 'Affiliation': 'Department of Medicine, University of British Columbia, Vancouver, BC, Canada; British Columbia Centre on Substance Use, Vancouver, BC, Canada.'}, {'ForeName': 'Brandon Dl', 'Initials': 'BD', 'LastName': 'Marshall', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': 'School of Population and Public Health, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Wood', 'Affiliation': 'Department of Medicine, University of British Columbia, Vancouver, BC, Canada; British Columbia Centre on Substance Use, Vancouver, BC, Canada.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kerr', 'Affiliation': 'Department of Medicine, University of British Columbia, Vancouver, BC, Canada; British Columbia Centre on Substance Use, Vancouver, BC, Canada.'}]",The Lancet. Public health,['10.1016/S2468-2667(21)00023-2'] 3962,33857436,"Effect of an electronic nicotine delivery system with 0, 8, or 36 mg/mL liquid nicotine versus a cigarette substitute on tobacco-related toxicant exposure: a four-arm, parallel-group, randomised, controlled trial.","BACKGROUND Electronic nicotine delivery systems (ENDSs) are used by some smokers to reduce cigarette consumption, but their effectiveness is uncertain. We aimed to examine the extent to which ENDSs or a non-nicotine cigarette substitute influence tobacco-related toxicant exposure and cigarette consumption in smokers interested in smoking reduction. METHODS We did a four-arm, parallel-group, randomised controlled trial at two sites in the USA (Penn State University, Hershey, PA, and Virginia Commonwealth University, Richmond, VA). We enrolled adults aged 21-65 years who smoked more than nine cigarettes per day (for at least the past year), with exhaled CO of more than 9 parts per million at screening, who were not currently using an ENDS, and who were interested in reducing smoking but not quitting. Participants were randomised (site-specific with allocation concealment; 1:1:1:1) to receive either a cartomiser-based, pen-style ENDS (eGo-style) paired with 0, 8, or 36 mg/mL liquid nicotine (participants and researchers masked to concentration) or a non-ENDS cigarette-shaped plastic tube that delivered no nicotine or aerosol (cigarette substitute; unmasked) for 24 weeks. Conditions were chosen to reflect a range of nicotine delivery including none (cigarette substitute and 0 mg/mL ENDS), low (8 mg/mL), and cigarette-like (36 mg/mL), and all conditions were paired with smoking reduction instructions. The primary outcome was concentration of the tobacco-specific carcinogen metabolite 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL; urinary total) collected at randomisation and at 4, 12, and 24 weeks. Multiple imputation with and without covariate adjustment was used in addition to sensitivity analyses. This trial is registered with ClinicalTrials.gov, NCT02342795. FINDINGS Between July 22, 2015, and Nov 16, 2017, 684 individuals were screened and 520 (76%) were enrolled and randomised. 188 (36%) of 520 participants were lost to follow-up by week 24; attrition did not differ by study group (39 [30%] of 130 in the cigarette substitute group, 56 [43%] of 130 in the ENDS with 0 mg/mL nicotine group, 49 [38%] of 130 in the ENDS 8 mg/mL group, and 44 [34%] of 130 in the ENDS 36 mg/mL group). Urinary total NNAL at 24 weeks in the ENDS with 36 mg/mL nicotine group was 210·80 pg/mg creatinine (95% CI 163·03-274·42) compared with 346·09 pg/mg creatinine (265·00-455·32) in the cigarette substitute group (p=0·0061). No other significant differences between groups were observed for any time point for urinary total NNAL. Serious adverse event frequency was similar across groups (12 events in 12 participants [9%] in the ENDS with 36 mg/mL nicotine group, seven events in six participants [5%] in the 8 mg/mL group, 11 events in ten participants [8%] in the 0 mg/mL group, and 13 events in 13 participants [10%] in the cigarette substitute group), and all of these were deemed unrelated or unlikely to be related to study product use. There was one death between randomisation and 24 weeks (suicide; in the ENDS with 0 mg/mL nicotine group). INTERPRETATION Use of an ENDS with cigarette-like nicotine delivery can reduce exposure to a major pulmonary carcinogen, NNAL, even with concurrent smoking. Future ENDS trials should involve products with well characterised nicotine delivery, including those with nicotine delivery approaching that of a cigarette. FUNDING National Institutes of Health, US Food and Drug Administration.",2021,"Serious adverse event frequency was similar across groups (12 events in 12 participants [9%] in the ENDS with 36 mg/mL nicotine group, seven events in six participants [5%] in the 8 mg/mL group, 11 events in ten participants [8%] in the 0 mg/mL group, and 13 events in 13 participants [10%] in the cigarette substitute group), and all of these were deemed unrelated or unlikely to be related to study product use.","['smokers interested in smoking reduction', 'enrolled adults aged 21-65 years who smoked more than nine cigarettes per day (for at least the past year), with exhaled CO of more than 9 parts per million at screening, who were not currently using an ENDS, and who were interested in reducing smoking but not quitting', 'Between July 22, 2015, and Nov 16, 2017, 684 individuals were screened and 520 (76%) were enrolled and randomised']","['ENDSs or a non-nicotine cigarette substitute influence tobacco-related toxicant exposure and cigarette consumption', 'electronic nicotine delivery system with 0, 8, or 36 mg/mL liquid nicotine', 'mL nicotine', 'cartomiser-based, pen-style ENDS (eGo-style) paired with 0, 8, or 36 mg/mL liquid nicotine (participants and researchers masked to concentration) or a non-ENDS cigarette-shaped plastic tube that delivered no nicotine or aerosol (cigarette substitute']","['concentration of the tobacco-specific carcinogen metabolite 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL; urinary total', 'Urinary total NNAL', 'time point for urinary total NNAL', 'Serious adverse event frequency']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C4505208', 'cui_str': 'Smoking Reduction'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517803', 'cui_str': '520'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0070220', 'cui_str': 'penclomedine'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0013712', 'cui_str': 'Ego'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0336633', 'cui_str': 'Plastic tube'}, {'cui': 'C0001712', 'cui_str': 'Aerosol'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0007090', 'cui_str': 'Carcinogen'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0389836', 'cui_str': '4-(methylnitrosamino)-1-(3-pyridyl)-1-butan-1-ol'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",520.0,0.316752,"Serious adverse event frequency was similar across groups (12 events in 12 participants [9%] in the ENDS with 36 mg/mL nicotine group, seven events in six participants [5%] in the 8 mg/mL group, 11 events in ten participants [8%] in the 0 mg/mL group, and 13 events in 13 participants [10%] in the cigarette substitute group), and all of these were deemed unrelated or unlikely to be related to study product use.","[{'ForeName': 'Caroline O', 'Initials': 'CO', 'LastName': 'Cobb', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond, VA, USA; Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, VA, USA. Electronic address: cobbco@vcu.edu.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Foulds', 'Affiliation': 'Center for Research on Tobacco and Health, Penn State University College of Medicine, Hershey, PA, USA; Department of Public Health Sciences, Penn State University College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Miao-Shan', 'Initials': 'MS', 'LastName': 'Yen', 'Affiliation': 'Department of Biostatistics, Virginia Commonwealth University, Richmond, VA, USA; Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Veldheer', 'Affiliation': 'Center for Research on Tobacco and Health, Penn State University College of Medicine, Hershey, PA, USA; Department of Public Health Sciences, Penn State University College of Medicine, Hershey, PA, USA; Department of Family and Community Medicine, Penn State University College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Alexa A', 'Initials': 'AA', 'LastName': 'Lopez', 'Affiliation': 'University of Wisconsin-Milwaukee, Milwaukee, WI, USA.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Yingst', 'Affiliation': 'Center for Research on Tobacco and Health, Penn State University College of Medicine, Hershey, PA, USA; Department of Public Health Sciences, Penn State University College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bullen', 'Affiliation': 'University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Le', 'Initials': 'L', 'LastName': 'Kang', 'Affiliation': 'Department of Biostatistics, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Eissenberg', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond, VA, USA; Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(21)00022-9'] 3963,33857414,"Adjuvant pembrolizumab versus placebo in resected stage III melanoma (EORTC 1325-MG/KEYNOTE-054): health-related quality-of-life results from a double-blind, randomised, controlled, phase 3 trial.","BACKGROUND The European Organisation for Research and Treatment of Cancer (EORTC) 1325-MG/KEYNOTE-054 trial in patients with resected, high-risk stage III melanoma demonstrated improved recurrence-free survival with adjuvant pembrolizumab compared with placebo (hazard ratio 0·57 [98·4% CI 0·43-0·74]; p<0·0001). This study reports the results from the health-related quality-of-life (HRQOL) exploratory endpoint. METHODS This double-blind, randomised, controlled, phase 3 trial was done at 123 academic centres and community hospitals across 23 countries. Patients aged 18 years or older with previously untreated histologically confirmed stage IIIA, IIIB, or IIIC resected cutaneous melanoma, and an Eastern Cooperative Oncology Group performance status score of 1 or 0 were eligible. Patients were randomly assigned (1:1) using a central interactive voice-response system on the basis of a minimisation technique stratified for stage and geographic region to receive intravenously 200 mg pembrolizumab or placebo. Treatment was administered every 3 weeks for 1 year, or until disease recurrence, unacceptable toxicity, or death. The primary endpoint of the trial was recurrence-free survival (reported elsewhere). HRQOL was a prespecified exploratory endpoint, with global health/quality of life (GHQ) over 2 years measured by the EORTC QLQ-C30 as the primary analysis. Analyses were done in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT02362594, and EudraCT, 2014-004944-37, and long-term follow-up is ongoing. FINDINGS Between Aug 26, 2015, and Nov 14, 2016, 1019 patients were assigned to pembrolizumab (n=514) or placebo (n=505). Median follow-up was 15·1 months (IQR 12·8-16·9) at the time of this analysis. HRQOL compliance was greater than 90% at baseline, greater than 70% during the first year, and greater than 60% thereafter for both groups. Because of low absolute compliance numbers at later follow-up, the analysis was truncated to week 84. Baseline GHQ scores were similar between groups (77·55 [SD 18·20] in the pembrolizumab group and 76·54 [17·81] in the placebo group) and remained stable over time. The difference in average GHQ score between the two groups over the 2 years was -2·2 points (95% CI -4·3 to -0·2). The difference in average score during treatment was -1·1 points (95% CI -3·2 to 0·9) and the difference in average score after treatment was -2·2 points (-4·8 to 0·4). These differences are within the 5-point clinical relevance threshold for the QLQ-C30 and are therefore clinically non-significant. INTERPRETATION Pembrolizumab does not result in a clinically significant decrease in HRQOL compared with placebo when given as adjuvant therapy for patients with resected, high-risk stage III melanoma. These results support the use of adjuvant pembrolizumab in this setting. FUNDING Merck Sharp & Dohme.",2021,Baseline GHQ scores were similar between groups (77·55 [SD 18·20] in the pembrolizumab group and 76·54 [17·81] in the placebo group) and remained stable over time.,"['Patients aged 18 years or older with previously untreated histologically confirmed stage IIIA, IIIB, or IIIC resected cutaneous melanoma, and an Eastern Cooperative Oncology Group performance status score of 1 or 0 were eligible', 'patients with resected, high-risk stage III melanoma', 'Between Aug 26, 2015, and Nov 14, 2016, 1019 patients were assigned to', 'Cancer (EORTC', '123 academic centres and community hospitals across 23 countries', '2014-004944-37, and long-term follow-up is ongoing']","['central interactive voice-response system', 'Adjuvant pembrolizumab versus placebo', 'placebo', 'pembrolizumab', 'pembrolizumab or placebo']","['recurrence-free survival', 'global health/quality of life (GHQ', 'average GHQ score', 'HRQOL compliance', 'average score', 'HRQOL', 'Baseline GHQ scores', 'unacceptable toxicity, or death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0456598', 'cui_str': 'Stage 3A'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0450318', 'cui_str': '1019'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",1019.0,0.920801,Baseline GHQ scores were similar between groups (77·55 [SD 18·20] in the pembrolizumab group and 76·54 [17·81] in the placebo group) and remained stable over time.,"[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bottomley', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium. Electronic address: andrew.bottomley@eortc.org.'}, {'ForeName': 'Corneel', 'Initials': 'C', 'LastName': 'Coens', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Justyna', 'Initials': 'J', 'LastName': 'Mierzynska', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Christian U', 'Initials': 'CU', 'LastName': 'Blank', 'Affiliation': 'Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, Netherlands.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Mandalà', 'Affiliation': 'University of Perugia, Santa Maria della Misericordia Hospital, Perugia, Italy.'}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Melanoma Institute Australia, The University of Sydney, and Mater and Royal North Shore Hospitals, Sydney, NSW, Australia.'}, {'ForeName': 'Victoria G', 'Initials': 'VG', 'LastName': 'Atkinson', 'Affiliation': 'Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Dalle', 'Affiliation': 'Hospices Civils de Lyon Cancer Institute, Lyon, France.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Haydon', 'Affiliation': 'Alfred Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Meshcheryakov', 'Affiliation': 'N N Blokhin Cancer Research Center, Moscow, Russia.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Khattak', 'Affiliation': 'Fiona Stanley Hospital & Edith Cowan University, Perth, WA, Australia.'}, {'ForeName': 'Matteo S', 'Initials': 'MS', 'LastName': 'Carlino', 'Affiliation': 'Westmead and Blacktown Hospitals, Melanoma Institute Australia and the University of Sydney, NSW, Australia.'}, {'ForeName': 'Shahneen', 'Initials': 'S', 'LastName': 'Sandhu', 'Affiliation': 'Peter Maccallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Puig', 'Affiliation': 'Hospital Clinic de Barcelona & Universitat de Barcelona & CIBERER, ISCIII, Barcelona, Spain.'}, {'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Istituto Nazionale Tumori IRCCS, Fondazione G Pascale, Naples, Italy.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Lorigan', 'Affiliation': 'Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'University Hospital Essen, Essen and German Cancer Consortium, Heidelberg, Germany.'}, {'ForeName': 'Rutger', 'Initials': 'R', 'LastName': 'Koornstra', 'Affiliation': 'Radboud University Medical Center Nijmegen, Nijmegen, Netherlands.'}, {'ForeName': 'Leonel', 'Initials': 'L', 'LastName': 'Hernandez-Aya', 'Affiliation': 'Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Di Giacomo', 'Affiliation': 'Center for Immuno-Oncology, University Hospital of Siena, Siena, Italy.'}, {'ForeName': 'Alfonsus J M', 'Initials': 'AJM', 'LastName': 'van den Eertwegh', 'Affiliation': 'Amsterdam University Medical Center, VUMC, Amsterdam, Netherlands.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Aix-Marseille University, Hôpital de la Timone, Marseille, France.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Gutzmer', 'Affiliation': 'Skin Cancer Center, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Rahima', 'Initials': 'R', 'LastName': 'Jamal', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal (CHUM), Centre de Recherche du CHUM, Montreal, QC, Canada.""}, {'ForeName': 'Alexander C J', 'Initials': 'ACJ', 'LastName': 'van Akkooi', 'Affiliation': 'Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, Netherlands.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Krepler', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Nageatte', 'Initials': 'N', 'LastName': 'Ibrahim', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Marreaud', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kicinski', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Suciu', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Gustave Roussy Cancer Institute & University Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Alexander M M', 'Initials': 'AMM', 'LastName': 'Eggermont', 'Affiliation': 'Princess Máxima Center, Utrecht, Netherlands; University Medical Center Utrecht, Utrecht, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(21)00081-4'] 3964,33857412,"Adjuvant pembrolizumab versus placebo in resected stage III melanoma (EORTC 1325-MG/KEYNOTE-054): distant metastasis-free survival results from a double-blind, randomised, controlled, phase 3 trial.","BACKGROUND The European Organisation for Research and Treatment of Cancer (EORTC) 1325/KEYNOTE-054 trial assessed pembrolizumab versus placebo in patients with resected high-risk stage III melanoma. At 15-month median follow-up, pembrolizumab improved recurrence-free survival (hazard ratio [HR] 0·57 [98·4% CI 0·43-0·74], p<0·0001) compared with placebo, leading to its approval in the USA and Europe. This report provides the final results for the secondary efficacy endpoint, distant metastasis-free survival and an update of the recurrence-free survival results. METHODS This double-blind, randomised, controlled, phase 3 trial was done at 123 academic centres and community hospitals across 23 countries. Patients aged 18 years or older with complete resection of cutaneous melanoma metastatic to lymph node, classified as American Joint Committee on Cancer staging system, seventh edition (AJCC-7) stage IIIA (at least one lymph node metastasis >1 mm), IIIB, or IIIC (without in-transit metastasis), and with an Eastern Cooperative Oncology Group performance status of 0 or 1 were eligible. Patients were randomly assigned (1:1) via a central interactive voice response system to receive intravenous pembrolizumab 200 mg or placebo every 3 weeks for up to 18 doses or until disease recurrence or unacceptable toxicity. Randomisation was stratified according to disease stage and region, using a minimisation technique, and clinical investigators, patients, and those collecting or analysing the data were masked to treatment assignment. The two coprimary endpoints were recurrence-free survival in the intention-to-treat (ITT) population and in patients with PD-L1-positive tumours. The secondary endpoint reported here was distant metastasis-free survival in the ITT and PD-L1-positive populations. This study is registered with ClinicalTrials.gov, NCT02362594, and EudraCT, 2014-004944-37. FINDINGS Between Aug 26, 2015, and Nov 14, 2016, 1019 patients were assigned to receive either pembrolizumab (n=514) or placebo (n=505). At an overall median follow-up of 42·3 months (IQR 40·5-45·9), 3·5-year distant metastasis-free survival was higher in the pembrolizumab group than in the placebo group in the ITT population (65·3% [95% CI 60·9-69·5] in the pembrolizumab group vs 49·4% [44·8-53·8] in the placebo group; HR 0·60 [95% CI 0·49-0·73]; p<0·0001). In the 853 patients with PD-L1-positive tumours, 3·5-year distant metastasis-free survival was 66·7% (95% CI 61·8-71·2) in the pembrolizumab group and 51·6% (46·6-56·4) in the placebo group (HR 0·61 [95% CI 0·49-0·76]; p<0·0001). Recurrence-free survival remained longer in the pembrolizumab group 59·8% (95% CI 55·3-64·1) than the placebo group 41·4% (37·0-45·8) at this 3·5-year follow-up in the ITT population (HR 0·59 [95% CI 0·49-0·70]) and in those with PD-L1-positive tumours 61·4% (56·3-66·1) in the pembrolizumab group and 44·1% (39·2-48·8) in the placebo group (HR 0·59 [95% CI 0·49-0·73]). INTERPRETATION Pembrolizumab adjuvant therapy provided a significant and clinically meaningful improvement in distant metastasis-free survival at a 3·5-year median follow-up, which was consistent with the improvement in recurrence-free survival. Therefore, the results of this trial support the indication to use adjuvant pembrolizumab therapy in patients with resected high risk stage III cutaneous melanoma. FUNDING Merck Sharp & Dohme.",2021,"INTERPRETATION Pembrolizumab adjuvant therapy provided a significant and clinically meaningful improvement in distant metastasis-free survival at a 3·5-year median follow-up, which was consistent with the improvement in recurrence-free survival.","['patients with resected high risk stage III cutaneous melanoma', '2014-004944-37', 'Between Aug 26, 2015, and Nov 14, 2016', '1019 patients', 'Cancer (EORTC', '853 patients with PD-L1-positive tumours', 'patients with resected high-risk stage III melanoma', '123 academic centres and community hospitals across 23 countries', 'Patients aged 18 years or older with complete resection of cutaneous melanoma metastatic to lymph node, classified as American Joint Committee on Cancer staging system']","['central interactive voice response system to receive intravenous pembrolizumab 200 mg or placebo', 'Adjuvant pembrolizumab versus placebo', 'pembrolizumab versus placebo', 'pembrolizumab therapy', 'placebo', 'pembrolizumab']","['recurrence-free survival', 'Recurrence-free survival', '3·5-year distant metastasis-free survival', 'seventh edition (AJCC-7) stage IIIA ', 'distant metastasis-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0450318', 'cui_str': '1019'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0015250', 'cui_str': 'Complete excision'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0449394', 'cui_str': 'Staging system'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205441', 'cui_str': 'Seventh'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0456598', 'cui_str': 'Stage 3A'}]",1019.0,0.945927,"INTERPRETATION Pembrolizumab adjuvant therapy provided a significant and clinically meaningful improvement in distant metastasis-free survival at a 3·5-year median follow-up, which was consistent with the improvement in recurrence-free survival.","[{'ForeName': 'Alexander M M', 'Initials': 'AMM', 'LastName': 'Eggermont', 'Affiliation': 'Princess Máxima Center, Utrecht, Netherlands; University Medical Center Utrecht, Utrecht, Netherlands. Electronic address: alexander.eggermont@prinsesmaximacentrum.nl.'}, {'ForeName': 'Christian U', 'Initials': 'CU', 'LastName': 'Blank', 'Affiliation': 'Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, Netherlands.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Mandalà', 'Affiliation': 'Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Melanoma Institute Australia, the University of Sydney, and Mater and Royal North Shore Hospitals, Sydney, NSW, Australia.'}, {'ForeName': 'Victoria G', 'Initials': 'VG', 'LastName': 'Atkinson', 'Affiliation': 'Princess Alexandra Hospital, Brisbane, QLD, Australia.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Dalle', 'Affiliation': 'Hospices Civils de Lyon Cancer Institute, Lyon, France.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Haydon', 'Affiliation': 'Alfred Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Meshcheryakov', 'Affiliation': 'NN Blokhin Cancer Research Center, Moscow, Russia.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Khattak', 'Affiliation': 'Fiona Stanley Hospital & Edith Cowan University, Perth, WA, Australia.'}, {'ForeName': 'Matteo S', 'Initials': 'MS', 'LastName': 'Carlino', 'Affiliation': 'Westmead and Blacktown Hospitals, Melanoma Institute Australia and the University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Shahneen', 'Initials': 'S', 'LastName': 'Sandhu', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Puig', 'Affiliation': 'Hospital Clinic de Barcelona, Universitat de Barcelona, Spain & Centro de Investigación Biomédica en Red de Enfermedades Raras, Instituto de Salud Carlos III, Barcelona, Spain.'}, {'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Istituto Nazionale Tumori IRCCS ""Fondazione G Pascale"", Naples, Italy.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'University Hospital Essen, Essen and German Cancer Consortium, Heidelberg, Germany.'}, {'ForeName': 'Rutger', 'Initials': 'R', 'LastName': 'Koornstra', 'Affiliation': 'Radboud University Medical Center Nijmegen, Nijmegen, Netherlands.'}, {'ForeName': 'Leonel', 'Initials': 'L', 'LastName': 'Hernandez-Aya', 'Affiliation': 'Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Di Giacomo', 'Affiliation': 'Center for Immuno-Oncology, University Hospital of Siena, Siena, Italy.'}, {'ForeName': 'Alfonsus J M', 'Initials': 'AJM', 'LastName': 'van den Eertwegh', 'Affiliation': 'Amsterdam University Medical Center, VUMC, Amsterdam, Netherlands.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Aix Marseille University, Hôpital de la Timone, Marseille, France.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Gutzmer', 'Affiliation': 'Skin Cancer Center, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Rahima', 'Initials': 'R', 'LastName': 'Jamal', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal (CHUM), Centre de recherche du CHUM, Montreal, QC, Canada.""}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Lorigan', 'Affiliation': 'Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Alexander C J', 'Initials': 'ACJ', 'LastName': 'van Akkooi', 'Affiliation': 'Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, Netherlands.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Krepler', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Nageatte', 'Initials': 'N', 'LastName': 'Ibrahim', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Marreaud', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kicinski', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Suciu', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Gustave Roussy and Paris-Saclay University, Villejuif, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(21)00065-6'] 3965,33857411,"Induction chemotherapy with lobaplatin and fluorouracil versus cisplatin and fluorouracil followed by chemoradiotherapy in patients with stage III-IVB nasopharyngeal carcinoma: an open-label, non-inferiority, randomised, controlled, phase 3 trial.","BACKGROUND Cisplatin-based induction chemotherapy plus concurrent chemoradiotherapy in the treatment of patients with locoregionally advanced nasopharyngeal carcinoma has been recommended in the National Comprehensive Cancer Network Guidelines. However, cisplatin is associated with poor patient compliance and has notable side-effects. Lobaplatin, a third-generation platinum drug, has shown promising antitumour activity against several malignancies with less toxicity. In this study, we aimed to evaluate the efficacy of lobaplatin-based induction chemotherapy plus concurrent chemoradiotherapy over a cisplatin-based regimen in patients with locoregional, advanced nasopharyngeal carcinoma. METHODS In this open-label, non-inferiority, randomised, controlled, phase 3 trial done at five hospitals in China, patients aged 18-60 years with previously untreated, non-keratinising stage III-IVB nasopharyngeal carcinoma; Karnofsky performance-status score of at least 70; and adequate haematological, renal, and hepatic function were randomly assigned (1:1) to receive intravenously either lobaplatin-based (lobaplatin 30 mg/m 2 on days 1 and 22, and fluorouracil 800 mg/m 2 on days 1-5 and 22-26 for two cycles) or cisplatin-based (cisplatin 100 mg/m 2 on days 1 and 22, and fluorouracil 800 mg/m 2 on days 1-5 and 22-26 for two cycles) induction chemotherapy, followed by concurrent lobaplatin-based (two cycles of intravenous lobaplatin 30 mg/m 2 every 3 weeks plus intensity-modulated radiotherapy) or cisplatin-based (two cycles of intravenous cisplatin 100 mg/m 2 every 3 weeks plus intensity-modulated radiotherapy) chemoradiotherapy. Total radiation doses of 68-70 Gy (for the sum of the volumes of the primary tumour and enlarged retropharyngeal nodes), 62-68 Gy (for the volume of clinically involved gross cervical lymph nodes), 60 Gy (for the high-risk target volume), and 54 Gy (for the low-risk target volume), were administered in 30-32 fractions, 5 days per week. Randomisation was done centrally at the clinical trial centre of Sun Yat-sen University Cancer Centre by means of computer-generated random number allocation with a block design (block size of four) stratified according to disease stage and treatment centre. Treatment assignment was known to both clinicians and patients. The primary endpoint was 5-year progression-free survival, analysed in both the intention-to-treat and per-protocol populations. If the upper limit of the 95% CI for the difference in 5-year progression-free survival between the lobaplatin-based and cisplatin-based groups did not exceed 10%, non-inferiority was met. Adverse events were analysed in all patients who received at least one cycle of induction chemotherapy. This trial is registered with the Chinese Clinical Trial Registry, ChiCTR-TRC-13003285 and is closed. FINDINGS From June 7, 2013, to June 16, 2015, 515 patients were assessed for eligibility and 502 patients were enrolled: 252 were randomly assigned to the lobaplatin-based group and 250 to the cisplatin-based group. After a median follow-up of 75·3 months (IQR 69·9-81·1) in the intention-to-treat population, 5-year progression-free survival was 75·0% (95% CI 69·7-80·3) in the lobaplatin-based group and 75·5% (70·0 to 81·0) in the cisplatin-based group (hazard ratio [HR] 0·98, 95% CI 0·69-1·39; log-rank p=0·92), with a difference of 0·5% (95% CI -7·1 to 8·1; p non-inferiority =0·0070). In the per-protocol population, the 5-year progression-free survival was 74·8% (95% CI 69·3 to 80·3) in the lobaplatin-based group and 76·4% (70·9 to 81·9) in the cisplatin-based group (HR 1·04, 95% CI 0·73 to 1·49; log-rank p=0·83), with a difference of 1·6% (-6·1 to 9·3; p non-inferiority =0·016). 63 (25%) of 252 patients in the lobaplatin-based group and 63 (25%) of 250 patients in the cisplatin-based group had a progression-free survival event in the intention-to-treat population; 62 (25%) of 246 patients in the lobaplatin-based group and 58 (25%) of 237 patients in the cisplatin-based group had a progression-free survival event in the per-protocol population. The most common grade 3-4 adverse events were mucositis (102 [41%] of 252 in the lobaplatin-based group vs 99 [40%] of 249 in the cisplatin-based group), leucopenia (39 [16%] vs 56 [23%]), and neutropenia (25 [10%] vs 59 [24%]). No treatment-related deaths were reported. INTERPRETATION Lobaplatin-based induction chemotherapy plus concurrent chemoradiotherapy resulted in non-inferior survival and fewer toxic effects than cisplatin-based therapy. The results of our trial indicate that lobaplatin-based induction chemotherapy plus concurrent chemoradiotherapy might be a promising alternative regimen to cisplatin-based treatment in patients with locoregional, advanced nasopharyngeal carcinoma. FUNDING National Science and Technology Pillar Program, International Cooperation Project of Science and Technology Program of Guangdong Province, Planned Science and Technology Project of Guangdong Province, and Cultivation Foundation for the Junior Teachers at Sun Yat-sen University. TRANSLATION For the Chinese translation of the abstract see Supplementary Materials section.",2021,"INTERPRETATION Lobaplatin-based induction chemotherapy plus concurrent chemoradiotherapy resulted in non-inferior survival and fewer toxic effects than cisplatin-based therapy.","['patients with locoregionally advanced nasopharyngeal carcinoma', 'Junior Teachers at Sun Yat-sen University', 'From June 7, 2013, to June 16, 2015, 515 patients were assessed for eligibility and 502 patients were enrolled: 252', 'patients with locoregional, advanced nasopharyngeal carcinoma', 'five hospitals in China, patients aged 18-60 years with previously untreated, non-keratinising stage III-IVB nasopharyngeal carcinoma; Karnofsky performance-status score of at least 70; and adequate haematological, renal, and hepatic function', 'patients with stage III-IVB nasopharyngeal carcinoma']","['intensity-modulated radiotherapy) chemoradiotherapy', 'Lobaplatin-based induction chemotherapy plus concurrent chemoradiotherapy', 'Cisplatin-based induction chemotherapy plus concurrent chemoradiotherapy', 'cisplatin', 'fluorouracil 800', 'cisplatin-based regimen', 'induction chemotherapy, followed by concurrent lobaplatin-based (two cycles of intravenous lobaplatin 30 mg/m 2 every 3 weeks plus intensity-modulated radiotherapy) or cisplatin-based (two cycles of intravenous cisplatin 100', 'lobaplatin-based group and 250 to the cisplatin-based group', 'cisplatin-based therapy', 'lobaplatin-based (lobaplatin 30 mg/m 2 on days 1 and 22, and fluorouracil 800 mg/m 2 on days 1-5 and 22-26 for two cycles) or cisplatin-based (cisplatin 100', 'lobaplatin-based induction chemotherapy plus concurrent chemoradiotherapy', 'Induction chemotherapy with lobaplatin and fluorouracil versus cisplatin and fluorouracil followed by chemoradiotherapy']","['Adverse events', 'leucopenia', 'progression-free survival event', '5-year progression-free survival', 'toxic effects', 'neutropenia', 'mucositis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036644', 'cui_str': 'Senegal'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C4545792', 'cui_str': 'KPS (Karnofsky Performance Status) score'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0165747', 'cui_str': 'lobaplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}]",515.0,0.138174,"INTERPRETATION Lobaplatin-based induction chemotherapy plus concurrent chemoradiotherapy resulted in non-inferior survival and fewer toxic effects than cisplatin-based therapy.","[{'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Lv', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China; Department of Critical Care Medicine, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Wei-Xiong', 'Initials': 'WX', 'LastName': 'Xia', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Kui-Yuan', 'Initials': 'KY', 'LastName': 'Liu', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Meng-Yun', 'Initials': 'MY', 'LastName': 'Qiang', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Chao-Nan', 'Initials': 'CN', 'LastName': 'Qian', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Ka-Jia', 'Initials': 'KJ', 'LastName': 'Cao', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Hao-Yuan', 'Initials': 'HY', 'LastName': 'Mo', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Xian-Ming', 'Initials': 'XM', 'LastName': 'Li', 'Affiliation': ""Department of Radiation Oncology, Shenzhen People's Hospital, Clinical Medical College of Jinan University, Shenzhen, China.""}, {'ForeName': 'Zi-Huang', 'Initials': 'ZH', 'LastName': 'Li', 'Affiliation': ""Department of Radiation Oncology, Shenzhen People's Hospital, Clinical Medical College of Jinan University, Shenzhen, China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Han', 'Affiliation': 'Department of Radiation Oncology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Yu-Xiang', 'Initials': 'YX', 'LastName': 'He', 'Affiliation': 'Department of Radiation Oncology, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yu-Meng', 'Initials': 'YM', 'LastName': 'Liu', 'Affiliation': ""Department of Radiation Oncology, Zhongshan People's Hospital, Zhongshan, China.""}, {'ForeName': 'Shao-Xiong', 'Initials': 'SX', 'LastName': 'Wu', 'Affiliation': 'Department of Radiation Oncology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Yong-Rui', 'Initials': 'YR', 'LastName': 'Bai', 'Affiliation': 'Department of Radiation Oncology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Liang-Ru', 'Initials': 'LR', 'LastName': 'Ke', 'Affiliation': 'Department of Medical Imaging, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Wen-Ze', 'Initials': 'WZ', 'LastName': 'Qiu', 'Affiliation': 'Department of Radiation Oncology, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Guo-Ying', 'Initials': 'GY', 'LastName': 'Liu', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Jing-Jing', 'Initials': 'JJ', 'LastName': 'Miao', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Wang-Zhong', 'Initials': 'WZ', 'LastName': 'Li', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Shu-Hui', 'Initials': 'SH', 'LastName': 'Lv', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Yan-Qun', 'Initials': 'YQ', 'LastName': 'Xiang', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China. Electronic address: guoxiang@sysucc.org.cn.'}]",The Lancet. Oncology,['10.1016/S1470-2045(21)00075-9'] 3966,33857327,"Relationship between metabolic toxicity and efficacy of everolimus in patients with neuroendocrine tumors: A pooled analysis from the randomized, phase 3 RADIANT-3 and RADIANT-4 trials.","BACKGROUND Hyperglycemia and hypercholesterolemia are class effects of mammalian target of rapamycin inhibitors such as everolimus. This post hoc pooled analysis assessed the potential impact of these events on the efficacy of everolimus. METHODS Patients with advanced, low- or intermediate-grade pancreatic, gastrointestinal, or lung neuroendocrine tumors received either oral everolimus at 10 mg/d or a placebo in the RAD001 in Advanced Neuroendocrine Tumors 3 (RADIANT-3) and RAD001 in Advanced Neuroendocrine Tumors 4 (RADIANT-4) trials. A landmark progression-free survival (PFS) analysis by central review was performed for patients treated for at least 16 weeks (n = 308) and according to the occurrence of any-grade adverse events (AEs) within this treatment period. RESULTS The overall PFS with everolimus from the pooled analysis was 11.4 months (95% confidence interval, 11.01-13.93 months), which was consistent with the findings of RADIANT-3 and RADIANT-4. Overall, 19.1% and 9.8% of patients in RADIANT-3 and 11.9% and 6.4% of patients in RADIANT-4 developed any-grade hyperglycemia and hypercholesterolemia, respectively (regardless of the study drug). The duration of everolimus exposure was longer in patients who developed these AEs versus patients without these AEs. Overall, 308 patients were exposed to treatment for at least 16 weeks (hyperglycemia, 39 of 269 patients; hypercholesterolemia, 20 of 288 patients). No association was observed between the development of these AEs and PFS (18.8 and 14.1 months with and without hyperglycemia, respectively, and 14.1 and 14.8 months with and without hypercholesterolemia, respectively). CONCLUSIONS Although limitations apply because of the small number of AEs observed, there was no significant impact of these AEs on PFS; this suggests similar efficacy in the presence or absence of these events.",2021,"The overall PFS with everolimus from the pooled analysis was 11.4 months (95% confidence interval, 11.01-13.93 months), which was consistent with the findings of RADIANT-3 and RADIANT-4.","['patients with neuroendocrine tumors', 'Patients with advanced, low- or intermediate-grade pancreatic, gastrointestinal, or lung neuroendocrine tumors received either', '308 patients were exposed to treatment for at least 16 weeks (hyperglycemia, 39 of 269 patients; hypercholesterolemia, 20 of 288 patients']","['placebo', 'everolimus', 'oral everolimus']","['duration of everolimus exposure', 'metabolic toxicity and efficacy', 'overall PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206754', 'cui_str': 'Neuroendocrine tumor'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",308.0,0.143956,"The overall PFS with everolimus from the pooled analysis was 11.4 months (95% confidence interval, 11.01-13.93 months), which was consistent with the findings of RADIANT-3 and RADIANT-4.","[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Fazio', 'Affiliation': 'European Institute of Oncology, IRCCS, Milan, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Carnaghi', 'Affiliation': 'Humanitas Research Hospital, IRCCS, Rozzano, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Buzzoni', 'Affiliation': 'National Cancer Institute, IRCCS Foundation, Milan, Italy.'}, {'ForeName': 'Juan W', 'Initials': 'JW', 'LastName': 'Valle', 'Affiliation': 'Division of Cancer Sciences, University of Manchester, Christie NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Herbst', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Ridolfi', 'Affiliation': 'Novartis Pharma SAS, Rueil-Malmaison, France.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Strosberg', 'Affiliation': 'Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Matthew H', 'Initials': 'MH', 'LastName': 'Kulke', 'Affiliation': 'Boston University and Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Marianne E', 'Initials': 'ME', 'LastName': 'Pavel', 'Affiliation': 'University of Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Yao', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas.'}]",Cancer,['10.1002/cncr.33540'] 3967,33857308,"Erratum to: SD1000: High Sustained Viral Response Rate in 1361 Patients With Hepatitis C Genotypes 1, 2, 3, and 4 Using a Low-cost Fixed-dose Combination Tablet of Generic Sofosbuvir and Daclatasvir: A Multicenter Phase III Clinical Trial.",,2021,,"['1361 Patients With Hepatitis C Genotypes 1, 2, 3, and 4 Using a']",['Low-cost Fixed-dose Combination Tablet of Generic Sofosbuvir and Daclatasvir'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C3252090', 'cui_str': 'daclatasvir'}]",[],,0.0534015,,"[{'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Merat', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Diseases Research Institute, Tehran University of Medical Sciences.'}, {'ForeName': 'Amir-Houshang', 'Initials': 'AH', 'LastName': 'Sharifi', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Diseases Research Institute, Tehran University of Medical Sciences.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Poustchi', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Diseases Research Institute, Tehran University of Medical Sciences.'}, {'ForeName': 'Eskandar', 'Initials': 'E', 'LastName': 'Hajiani', 'Affiliation': 'Alimentary Tract Research Center, School of Medicine, Jundishapur University of Medical Sciences, Ahvaz.'}, {'ForeName': 'Abdolsamad', 'Initials': 'A', 'LastName': 'Gharavi', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Diseases Research Institute, Tehran University of Medical Sciences.'}, {'ForeName': 'Jalal', 'Initials': 'J', 'LastName': 'Karimi', 'Affiliation': 'Department of Infectious Diseases and Tropical Medicine, Fasa University of Medical Sciences.'}, {'ForeName': 'Fariborz', 'Initials': 'F', 'LastName': 'Mansour-Ghanaei', 'Affiliation': 'Gastrointestinal and Liver Diseases Research Center, Guilan University of Medical Sciences, Rasht.'}, {'ForeName': 'Mohammad-Reza', 'Initials': 'MR', 'LastName': 'Fattahi', 'Affiliation': 'Gastroenterohepatology Research Center, Shiraz University of Medical Sciences.'}, {'ForeName': 'Lida', 'Initials': 'L', 'LastName': 'Ahmadi', 'Affiliation': 'Gastroenterohepatology Research Center, Shiraz University of Medical Sciences.'}, {'ForeName': 'Mohammad-Hossein', 'Initials': 'MH', 'LastName': 'Somi', 'Affiliation': 'Tabriz University of Medical Sciences.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Kalantari', 'Affiliation': 'Isfahan Liver Disease Research Center, Isfahan University of Medical Sciences.'}, {'ForeName': 'Mohammad-Reza', 'Initials': 'MR', 'LastName': 'Ghadir', 'Affiliation': 'Gastroenterology and Hepatology Disease Research Center, Qom University of Medical Sciences.'}, {'ForeName': 'Farshad', 'Initials': 'F', 'LastName': 'Sheikhesmaeili', 'Affiliation': 'Liver and Digestive Research Center, Kurdistan University of Medical Sciences, Sanandaj.'}, {'ForeName': 'Nadieh', 'Initials': 'N', 'LastName': 'Baniasadi', 'Affiliation': 'Bam University of Medical Sciences.'}, {'ForeName': 'Masoudreza', 'Initials': 'M', 'LastName': 'Sohrabi', 'Affiliation': 'Gastrointestinal and Liver Diseases Research Center, Iran University of Medical Sciences, Tehran.'}, {'ForeName': 'Seyedhamid', 'Initials': 'S', 'LastName': 'Moosavy', 'Affiliation': 'Hormozgan University of Medical Science, Bandarabbas, Iran.'}, {'ForeName': 'Masood', 'Initials': 'M', 'LastName': 'Ziaee', 'Affiliation': 'Infectious Diseases Research Center, Birjand University of Medical Sciences.'}, {'ForeName': 'Mohammad-Javad', 'Initials': 'MJ', 'LastName': 'Zahedi', 'Affiliation': 'Gastroenterology and Hepatology Research Center, Kerman University of Medical Sciences.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Mokhtare', 'Affiliation': 'Colorectal Research Center, Iran University of Medical Science.'}, {'ForeName': 'Shahnaz', 'Initials': 'S', 'LastName': 'Sali', 'Affiliation': 'Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Sayad', 'Affiliation': 'Infectious Diseases Research Center, Kermanshah University of Medical Sciences.'}, {'ForeName': 'Behrooz', 'Initials': 'B', 'LastName': 'Afshar', 'Affiliation': 'Hamadan University of Medical Sciences.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Bakhshipour', 'Affiliation': 'Infectious Diseases and Tropical Medicine Research Center, Zahedan University of Medical Sciences.'}, {'ForeName': 'Abazar', 'Initials': 'A', 'LastName': 'Parsi', 'Affiliation': 'Alimentary Tract Research Center, School of Medicine, Jundishapur University of Medical Sciences, Ahvaz.'}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Sharifian', 'Affiliation': 'Basic and Molecular Epidemiology of Gastrointestinal Disorders Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran.'}, {'ForeName': 'Taghi', 'Initials': 'T', 'LastName': 'Amiriani', 'Affiliation': 'Golestan Research Center for Gastroenterology and Hepatology, Golestan University of Medical Science, Gorgan.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Malekzadeh', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Diseases Research Institute, Tehran University of Medical Sciences.'}, {'ForeName': 'Dorsa', 'Initials': 'D', 'LastName': 'Merat', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Diseases Research Institute, Tehran University of Medical Sciences.'}, {'ForeName': 'Azita', 'Initials': 'A', 'LastName': 'Ganji', 'Affiliation': 'Department of Gastroenterology and Hepatology, Mashhad University of Medical Sciences.'}, {'ForeName': 'Fereidoun', 'Initials': 'F', 'LastName': 'Rahmani-Samani', 'Affiliation': 'Shahrekord University of Medical Sciences.'}, {'ForeName': 'Raika', 'Initials': 'R', 'LastName': 'Jamali', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Diseases Research Institute, Tehran University of Medical Sciences.'}, {'ForeName': 'Masoomeh', 'Initials': 'M', 'LastName': 'Sofian', 'Affiliation': 'Infectious Disease Research Center, Arak University of Medical Science.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ghezlou', 'Affiliation': 'Gastroenterology and Hepatology Disease Research Center, Arak Medical Sience University.'}, {'ForeName': 'Amir Ali', 'Initials': 'AA', 'LastName': 'Sohrabpour', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Diseases Research Institute, Tehran University of Medical Sciences.'}, {'ForeName': 'Ladan', 'Initials': 'L', 'LastName': 'Goshayeshi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Mashhad University of Medical Sciences.'}, {'ForeName': 'Seyed-Mohammad', 'Initials': 'SM', 'LastName': 'Valizadeh-Toosi', 'Affiliation': 'Gut and Liver Research Center, Mazandaran University Of Medical Sciences, Sari.'}, {'ForeName': 'Layli', 'Initials': 'L', 'LastName': 'Eslami', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Diseases Research Institute, Tehran University of Medical Sciences.'}, {'ForeName': 'Iradj', 'Initials': 'I', 'LastName': 'Maleki', 'Affiliation': 'Gut and Liver Research Center, Mazandaran University Of Medical Sciences, Sari.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Hormati', 'Affiliation': 'Gastroenterology and Hepatology Disease Research Center, Qom University of Medical Sciences.'}, {'ForeName': 'Ali-Akbar', 'Initials': 'AA', 'LastName': 'Shayesteh', 'Affiliation': 'Alimentary Tract Research Center, School of Medicine, Jundishapur University of Medical Sciences, Ahvaz.'}, {'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Shayesteh', 'Affiliation': 'Alimentary Tract Research Center, School of Medicine, Jundishapur University of Medical Sciences, Ahvaz.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Norouzi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Mashhad University of Medical Sciences.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Abna', 'Affiliation': 'Sirjan University of Medical Sciences.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Janbakhsh', 'Affiliation': 'Infectious Diseases Department, Kermanshah University of Medical Sciences.'}, {'ForeName': 'Hafez', 'Initials': 'H', 'LastName': 'Fakheri', 'Affiliation': 'Gut and Liver Research Center, Mazandaran University Of Medical Sciences, Sari.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Minakari', 'Affiliation': 'Isfahan University of Medical Sciences.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Sardarian', 'Affiliation': 'Guilan University of Medical Science, Bandar Anzali.'}, {'ForeName': 'Adel F Allah', 'Initials': 'AFA', 'LastName': 'Ghajary', 'Affiliation': 'Chamran Hospital of Saveh.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Fattahi-Abdizadeh', 'Affiliation': 'Department of Microbiology.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Latifnia', 'Affiliation': 'Department of Gastroenterology and Hepatology, Sabzevar University of Medical Sciences.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Roozbeh', 'Affiliation': 'Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Agah', 'Affiliation': 'Colorectal Research Center, Iran University of Medical Science.'}, {'ForeName': 'Saba', 'Initials': 'S', 'LastName': 'Fakhrieh-Asl', 'Affiliation': 'Gastrointestinal and Liver Diseases Research Center, Guilan University of Medical Sciences, Rasht.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Nateghi-Baygi', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Diseases Research Institute, Tehran University of Medical Sciences.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Fattahi', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Diseases Research Institute, Tehran University of Medical Sciences.'}, {'ForeName': 'Helia', 'Initials': 'H', 'LastName': 'Nateghi-Baygi', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Diseases Research Institute, Tehran University of Medical Sciences.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'Department of Translational Medicine, University of Liverpool, United Kingdom.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Malekzadeh', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Diseases Research Institute, Tehran University of Medical Sciences.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1768'] 3968,33857201,Repeated intermittent hypoxic stimuli to operative lung reduce hypoxemia during subsequent one-lung ventilation for thoracoscopic surgery: A randomized controlled trial.,"BACKGROUND An intervention to potentiate hypoxic pulmonary vasoconstriction may reduce intrapulmonary shunt and hypoxemia during one-lung ventilation. Previous animal studies reported that repeated intermittent hypoxic stimuli potentiated hypoxic pulmonary vasoconstriction, but no clinical study has examined the effects of this intervention on hypoxemia during one-lung ventilation. We thus performed a single-center, parallel-group, double-blind, randomized controlled trial to investigate whether repeated intermittent hypoxic stimuli to the operative lung reduce hypoxemia during the subsequent one-lung ventilation for thoracoscopic surgery. METHODS Patients undergoing one-lung ventilation were randomized into two groups (n = 68 each). Before one-lung ventilation, in the intermittent hypoxia group, the nondependent lung was not ventilated for 2 min and then ventilated for 2 min while the dependent lung was continuously ventilated. This was repeated five times. In the continuous normoxia group, both lungs were ventilated for 20 min. We measured SpO2, PaO2, FiO2, PaCO2, SaO2, and central venous oxygen saturation during one-lung ventilation. The primary outcome was the number of patients with hypoxemia defined as a SpO2 <95% during one-lung ventilation, which was analyzed with a chi-squared test. RESULTS Hypoxemia was less frequent in the intermittent hypoxia group than in the continuous normoxia group during OLV [6/68 (8.8%) vs 17/68 (25.0%), risk ratio (95% CI) 0.35 (0.15-0.84), p = 0.012]. The PaO2 (p = 0.008 for 30 min and 0.007 for 60 min) and PaO2/FiO2 (p = 0.008 for both) were higher 30 and 60 min after starting one-lung ventilation, and the alveolar-arterial pressure gradient (p = 0.010) and shunt index (p = 0.008) were lower 30 min after starting one-lung ventilation in the intermittent hypoxia group than in the continuous normoxia group. Postoperative adverse events did not differ significantly between groups. CONCLUSIONS Repeated intermittent hypoxic stimuli to the operative lung seemed to potentiate hypoxic pulmonary vasoconstriction, and thus reduced hypoxemia during the subsequent one-lung ventilation.",2021,"The PaO2 (p = 0.008 for 30 min and 0.007 for 60 min) and PaO2/FiO2 (p = 0.008 for both) were higher 30 and 60 min after starting one-lung ventilation, and the alveolar-arterial pressure gradient (p = 0.010) and shunt index (p = 0.008) were lower 30 min after starting one-lung ventilation in the intermittent hypoxia group than in the continuous normoxia group.","['thoracoscopic surgery', 'Patients undergoing one-lung ventilation']",['Repeated intermittent hypoxic stimuli to operative lung reduce hypoxemia during subsequent one-lung ventilation'],"['PaO2', 'alveolar-arterial pressure gradient', 'hypoxemia', 'number of patients with hypoxemia defined as a SpO2 <95% during one-lung ventilation', 'shunt index', 'Hypoxemia', 'PaO2/FiO2', 'risk ratio', 'Postoperative adverse events', 'reduced hypoxemia', 'SpO2, PaO2, FiO2, PaCO2, SaO2, and central venous oxygen saturation']","[{'cui': 'C0751551', 'cui_str': 'Thoracoscopic Surgical Procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}]","[{'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0232108', 'cui_str': 'Arterial pulse pressure'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C0542331', 'cui_str': 'Shunt'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0444466', 'cui_str': 'Central venous'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}]",,0.167101,"The PaO2 (p = 0.008 for 30 min and 0.007 for 60 min) and PaO2/FiO2 (p = 0.008 for both) were higher 30 and 60 min after starting one-lung ventilation, and the alveolar-arterial pressure gradient (p = 0.010) and shunt index (p = 0.008) were lower 30 min after starting one-lung ventilation in the intermittent hypoxia group than in the continuous normoxia group.","[{'ForeName': 'Susie', 'Initials': 'S', 'LastName': 'Yoon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Bo Rim', 'Initials': 'BR', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Se-Hee', 'Initials': 'SH', 'LastName': 'Min', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jaehun', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jae-Hyon', 'Initials': 'JH', 'LastName': 'Bahk', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jeong-Hwa', 'Initials': 'JH', 'LastName': 'Seo', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}]",PloS one,['10.1371/journal.pone.0249880'] 3969,33857180,"The effectiveness of two different exercise approaches in adolescent idiopathic scoliosis: A single-blind, randomized-controlled trial.","OBJECTIVES The purpose of this study was to compare the efficacy of two different types of exercise methods in patients with adolescent idiopathic scoliosis. METHODS In total, 28 subjects with adolescent idiopathic scoliosis with a mild curve magnitude (10°-26°) were randomly divided into two groups: the Schroth group (n = 14) and the core group (n = 14). The patients in the Schroth group were treated with supervised Schroth exercises, and the patients in the core group were treated with supervised core stabilization exercises; both groups performed the exercises for three days per week for a total of 10 weeks, and both were given additional traditional exercises to perform. Assessment included Cobb angle (Radiography), trunk rotation (Adam's test), cosmetic trunk deformity (Walter Reed Visual Assessment Scale), spinal mobility (Spinal Mouse), peripheral muscle strength (Biodex System 4-Pro), and quality of life (Scoliosis Research Society-22 questionnaire). RESULTS It was found that patients in the Schroth group showed greater improvement in Cobb angles, thoracic trunk rotation angle, cosmetic trunk deformity, spinal mobility, and quality of life than those in the core group (p<0.05), except for in lumbar trunk rotation angle. Peripheral muscle strength improvement was greater in the core group than in the Schroth group (p<0.05). CONCLUSION Schroth exercises are more effective than core stabilization exercises in the correction of scoliosis and related problems in mild adolescent idiopathic scoliosis, and core stabilization exercises are more effective than Schroth exercises in the improvement of peripheral muscle strength. TRIAL REGISTRATION NCT04421157.",2021,"Peripheral muscle strength improvement was greater in the core group than in the Schroth group (p<0.05). ","['28 subjects with adolescent idiopathic scoliosis with a mild curve magnitude (10°-26', 'mild adolescent idiopathic scoliosis', 'patients with adolescent idiopathic scoliosis', 'adolescent idiopathic scoliosis']","['supervised Schroth exercises', 'exercise approaches', 'exercise methods', 'core stabilization exercises', 'supervised core stabilization exercises', 'Schroth exercises']","['Cobb angles, thoracic trunk rotation angle, cosmetic trunk deformity, spinal mobility, and quality of life', 'Peripheral muscle strength improvement', ""Cobb angle (Radiography), trunk rotation (Adam's test), cosmetic trunk deformity (Walter Reed Visual Assessment Scale), spinal mobility (Spinal Mouse), peripheral muscle strength (Biodex System 4-Pro), and quality of life (Scoliosis Research Society-22 questionnaire""]","[{'cui': 'C0410702', 'cui_str': 'Adolescent idiopathic scoliosis'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}]","[{'cui': 'C0563192', 'cui_str': 'Cobb angle'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C1404203', 'cui_str': 'Trunk deformities'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1529905', 'cui_str': '(123I)ADAM'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0036439', 'cui_str': 'Scoliosis deformity of spine'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",28.0,0.0144328,"Peripheral muscle strength improvement was greater in the core group than in the Schroth group (p<0.05). ","[{'ForeName': 'Hikmet', 'Initials': 'H', 'LastName': 'Kocaman', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Prosthetics-Orthotics Physiotherapy, Karamanoglu Mehmetbey University, Karaman, Turkey.'}, {'ForeName': 'Nilgün', 'Initials': 'N', 'LastName': 'Bek', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Lokman Hekim University, Ankara, Turkey.'}, {'ForeName': 'Mehmet Hanifi', 'Initials': 'MH', 'LastName': 'Kaya', 'Affiliation': 'Faculty of Medicine, Ahi Evran University, Kırşehir, Turkey.'}, {'ForeName': 'Buket', 'Initials': 'B', 'LastName': 'Büyükturan', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Ahi Evran University, Kırşehir, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Yetiş', 'Affiliation': 'Department of Orthopedics and Traumatology, Faculty of Medicine, Ahi Evran University, Kırşehir, Turkey.'}, {'ForeName': 'Öznur', 'Initials': 'Ö', 'LastName': 'Büyükturan', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Ahi Evran University, Kırşehir, Turkey.'}]",PloS one,['10.1371/journal.pone.0249492'] 3970,33857169,Changes in plantar load distribution in legally blind subjects.,"We investigated the impact of visual impairment on balance control. We measured the center of pressure (COP) between the two feet and plantar surface pressures on each foot in 18 normal-sighted participants and compared their data with measures from 18 legally blind participants, either acquired or congenital. Pressures were measured in open- and closed-eye conditions using a baropodometric resistive plate. In the eyes-open condition, there were no differences between the sighted and legally blind groups in COP displacement. However, participants with visual loss had significantly increased pressures in two metatarsal regions (M1 and M2 zones) of the plantar surface in both viewing conditions (p < 0.05). The differences in pressure measures between the normally sighted and legally blind groups could be attributed mainly to the subgroup of subjects with acquired impairment. Our findings suggest that subjects with visual impairment present increased metatarsal pressures (i.e. forefoot), not yet associated to anterior displacement of COP or impaired balance control.",2021,"In the eyes-open condition, there were no differences between the sighted and legally blind groups in COP displacement.","['18 normal-sighted participants and compared their data with measures from 18 legally blind participants, either acquired or congenital', 'subjects with visual impairment', 'legally blind subjects']",[],"['pressure measures', 'COP displacement', 'center of pressure (COP', 'metatarsal pressures']","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0449770', 'cui_str': 'Measured from'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0042798', 'cui_str': 'Dim vision'}]",[],"[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0025584', 'cui_str': 'Metatarsal bone structure'}]",18.0,0.0419228,"In the eyes-open condition, there were no differences between the sighted and legally blind groups in COP displacement.","[{'ForeName': 'Ketlin Jaquelline Santana', 'Initials': 'KJS', 'LastName': 'Castro', 'Affiliation': 'Instituto de Ciências Biológicas, Universidade Federal do Pará, Belém, Brazil.'}, {'ForeName': 'Railson Cruz', 'Initials': 'RC', 'LastName': 'Salomão', 'Affiliation': 'Núcleo de Medicina Tropical, Universidade Federal do Pará, Belém, Brazil.'}, {'ForeName': 'Newton Quintino', 'Initials': 'NQ', 'LastName': 'Feitosa', 'Affiliation': 'Núcleo de Medicina Tropical, Universidade Federal do Pará, Belém, Brazil.'}, {'ForeName': 'Leonardo Dutra', 'Initials': 'LD', 'LastName': 'Henriques', 'Affiliation': 'Instituto de Psicologia, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ana Francisca Rozin', 'Initials': 'AFR', 'LastName': 'Kleiner', 'Affiliation': 'Departamento de Fisioterapia, Universidade Federal de São Carlos, São Carlos, Brazil.'}, {'ForeName': 'Anderson', 'Initials': 'A', 'LastName': 'Belgamo', 'Affiliation': 'Instituto Federal de São Paulo, Piracicaba, Brazil.'}, {'ForeName': 'André Santos', 'Initials': 'AS', 'LastName': 'Cabral', 'Affiliation': 'Centro de Ciências Biológicas e da Saúde, Universidade do Estado do Pará, Belém, Brazil.'}, {'ForeName': 'Anselmo Athayde', 'Initials': 'AA', 'LastName': 'Costa E Silva', 'Affiliation': ""Master's Program in Human Movement Sciences, Federal University of Pará, Belém, Pará, Brazil.""}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Callegari', 'Affiliation': ""Master's Program in Human Movement Sciences, Federal University of Pará, Belém, Pará, Brazil.""}, {'ForeName': 'Givago Silva', 'Initials': 'GS', 'LastName': 'Souza', 'Affiliation': 'Instituto de Ciências Biológicas, Universidade Federal do Pará, Belém, Brazil.'}]",PloS one,['10.1371/journal.pone.0249467'] 3971,33857051,Intervention Effect of the Integration Model on Negative Emotions of Adolescents during the Outbreak of Corona Virus Disease 2019.,"BACKGROUND The World Health Organization has declared the Corona Virus Disease 2019 (COVID-19) epidemic as a public health emergency of international concern. Given the sudden infection from and extensive dispersion of COVID-19 and the absence of specific drugs, those infected are in danger if they are not treated in time. Consequently, COVID-19 has become an important factor influencing adolescents' mental health. The purpose of this study is to explore the intervention effect of the integration model on the negative emotions of adolescents during the COVID-19 epidemic. SUBJECTS AND METHODS Adolescents were randomly selected from five middle schools in Zhejiang Province of China from May 2020 to July 2020. First, the Self-rating Anxiety Scale, Positive and Negative Affect Scale, and Psychological Well-Being Scale were used for measurement. Then, 72 patients with moderate and severe anxiety symptoms were chosen as the research objects, and the intervention and comparison time was determined to be eight weeks. The subjects were randomly divided into the experiment group (35 members) and the control group (34 members). The integration model was employed on the experiment group. RESULTS Grade, physical condition, and sleep time are important factors influencing the anxiety level of adolescents during the COVID-19 period, and the anxiety risk of adolescents is higher during their third year of junior high school. After the intervention, the SAS score of the experiment group is lower than that of the control group, and the decrease in the SAS score is higher in the experiment group than in the control group (P<0.01). Moreover, the positive emotion score of the experiment group is higher than that of the control group, and the negative emotion score of the former is lower than that of the latter. The variances in the positive and negative emotion scores are higher in the experiment group than in the control group (P<0.01). The variance in the overall well-being index is also greater in the experiment group than in the control group (P<0.01). CONCLUSION The intervention using the integrated model can significantly reduce negative emotions such as anxiety, increase positive emotions, and improve the overall well-being of adolescents during the epidemic period.",2021,The variances in the positive and negative emotion scores are higher in the experiment group than in the control group (P<0.01).,"['Negative Emotions of Adolescents during the Outbreak of Corona Virus Disease 2019', 'Adolescents were randomly selected from five middle schools in Zhejiang Province of China from May 2020 to July 2020', 'adolescents during the COVID-19 epidemic', '72 patients with moderate and severe anxiety symptoms']",['Integration Model'],"['positive emotion score', 'anxiety risk of adolescents', 'positive and negative emotion scores', 'negative emotions such as anxiety, increase positive emotions', 'negative emotion score', 'Self-rating Anxiety Scale, Positive and Negative Affect Scale, and Psychological Well-Being Scale', 'SAS score']","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0012652', 'cui_str': 'Disease outbreak'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0014499', 'cui_str': 'Epidemic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0231403', 'cui_str': 'Severe anxiety (panic)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}]",72.0,0.0125163,The variances in the positive and negative emotion scores are higher in the experiment group than in the control group (P<0.01).,"[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Institute of Physical Education and Health, Wenzhou University, Wenzhou 325035, China,orientationchen@163.com.'}, {'ForeName': 'Guoqiang', 'Initials': 'G', 'LastName': 'Sang', 'Affiliation': ''}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Aifeng', 'Initials': 'A', 'LastName': 'Jiang', 'Affiliation': ''}]",Psychiatria Danubina,['10.24869/psyd.2021.86'] 3972,33857028,Mononitrate Isosorbide as an Adjunctive Therapy in Schizophrenia: A Randomized Controlled Crossover Trial.,"BACKGROUND Schizophrenia is a complex disabling mental disorder, and many patients present poor response to available treatments. Accumulating evidence about the role of the glutamate/nitric oxide pathway in mediating the positive and negative symptoms of schizophrenia suggests potential benefits of drugs that modulate this system. The aim of this study was to test the efficacy of isosorbide mononitrate (ISMN) as an adjunctive therapy for symptomatic outpatients with schizophrenia. METHODS This was a 2-month randomized, double-blind, placebo-controlled trial with 24 schizophrenia patients. Participants were treated with ISMN 50 mg for 1 month and placebo for another month in a crossover design. The Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression Scale, Global Assessment of Functioning, and MATRICS Cognitive Consensual Battery were used for symptom assessment and arterial spin labeling was used to assess brain activation patterns. RESULTS We found significant differences in the total, general, and positive subscales of the PANSS, Global Assessment of Functioning scores, and Clinical Global Impression scores during treatment with ISMN relative to placebo. No treatment effects were found comparing scores in the MATRICS Cognitive Consensual Battery and the negative subscale of the PANSS between the active and placebo conditions. A post hoc analysis of neuroimaging data showed reduced activity in the thalamus in subgroup of patients with severe psychopathology. CONCLUSIONS Schizophrenia patients with persistent symptoms showed significant improvement after 4 weeks of treatment with ISMN 50 mg/d compared with placebo. Isosorbide mononitrate added beneficial effects to antipsychotic treatment in terms of positive symptoms and functioning.",2021,No treatment effects were found comparing scores in the MATRICS Cognitive Consensual Battery and the negative subscale of the PANSS between the active and placebo conditions.,"['24 schizophrenia patients', 'symptomatic outpatients with schizophrenia', 'Schizophrenia']","['Mononitrate Isosorbide', 'ISMN', 'placebo', 'Isosorbide', 'isosorbide mononitrate (ISMN']","['Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression Scale, Global Assessment of Functioning, and MATRICS Cognitive Consensual Battery', 'brain activation patterns', 'Cognitive Consensual Battery and the negative subscale of the PANSS', 'positive symptoms and functioning', 'total, general, and positive subscales of the PANSS, Global Assessment of Functioning scores, and Clinical Global Impression scores']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0064079', 'cui_str': 'isosorbide mononitrate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022251', 'cui_str': 'Isosorbide'}]","[{'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C3639708', 'cui_str': 'Clinical global impression scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",24.0,0.255588,No treatment effects were found comparing scores in the MATRICS Cognitive Consensual Battery and the negative subscale of the PANSS between the active and placebo conditions.,"[{'ForeName': 'Tiago M', 'Initials': 'TM', 'LastName': 'Guimarães', 'Affiliation': 'From the Neuroscience and Behavioral Sciences Department, Ribeirao Preto Medical School, University of São Paulo (USP) National Institute for Science and Technology - Translational Medicine (INCT - TM), CNPq/FAPESP/CAPES Physics Department, FFCLRP, University of São Paulo (USP), São Paulo, Brazil Spinoza Centre for Neuroimaging Experimental and Applied Psychology, VU University, Amsterdam, the Netherlands Radiology Division, Department of Internal Medicine, Ribeirao Preto Medical School, University of São Paulo USP), São Paulo, Brazil Department of Psychiatry, University of Alberta, Edmonton, Alberta, Canada Department of Psychiatry, Interdisciplinary Lab of Clinical Neurosciences (LiNC), and Schizophrenia Program (PROESQ), Federal São Paulo University (Unifesp), São Paulo, Brazil.'}, {'ForeName': 'Mara R C', 'Initials': 'MRC', 'LastName': 'Guimarães', 'Affiliation': ''}, {'ForeName': 'Ícaro A F', 'Initials': 'ÍAF', 'LastName': 'Oliveira', 'Affiliation': ''}, {'ForeName': 'Renata F', 'Initials': 'RF', 'LastName': 'Leoni', 'Affiliation': ''}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Santos', 'Affiliation': ''}, {'ForeName': 'Serdar M', 'Initials': 'SM', 'LastName': 'Dursun', 'Affiliation': ''}, {'ForeName': 'Jose A S', 'Initials': 'JAS', 'LastName': 'Crippa', 'Affiliation': ''}, {'ForeName': 'Rodrigo A', 'Initials': 'RA', 'LastName': 'Bressan', 'Affiliation': ''}, {'ForeName': 'João Paulo', 'Initials': 'JP', 'LastName': 'Machado-de-Sousa', 'Affiliation': ''}, {'ForeName': 'Acioly L T', 'Initials': 'ALT', 'LastName': 'Lacerda', 'Affiliation': ''}, {'ForeName': 'Jaime E C', 'Initials': 'JEC', 'LastName': 'Hallak', 'Affiliation': ''}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001388'] 3973,33857018,Milk polar lipids favorably alter circulating and intestinal ceramide and sphingomyelin species in postmenopausal women.,"BACKGROUND High circulating levels of ceramides (Cer) and sphingomyelins (SM) have been associated with cardiometabolic diseases. The consumption of whole-fat dairy products, which naturally contain such polar lipids (PL), is associated with health benefits, but the impact on sphingolipidome remains unknown. We investigated how milk PL supplementation impacts circulating and intestinal SM and Cer composition in association with improvement of cardiovascular markers. METHODS In a 4 week-randomized double-blind controlled study, 58 postmenopausal women consumed daily a cream cheese containing 0, 3 or 5 g of milk PL. Postprandial metabolic explorations were performed before and after the supplementation. SM and Cer species were analyzed in serum, intestine-derived chylomicrons and feces. The ileal content of 4 ileostomy patients was also explored after milk PL intake in a crossover double-blind study. RESULTS Milk PL consumption decreased serum atherogenic C24:1 Cer (Pgroup = 0.033), C16:1 (Pgroup = 0.007) and C18:1 (Pgroup = 0.003) SM species. Changes in serum C16+18 SM species were positively correlated with the reduction of total cholesterol (r = 0.706, P < 0.001), LDL-C (r = 0.666, P < 0.001) and ApoB (r = 0.705, P < 0.001). Milk PL decreased the concentration in chylomicrons of total SM (Pgroup < 0.0001) and of C24:1 Cer (Pgroup = 0.001). Saturated SM and Cer species, which are also the major species found in milk PL-enriched cheeses, increased in ileal efflux and feces. There was a marked increase in total fecal Cer after milk PL supplementation (Pgroup = 0.0002). Milk PL also modulated the abundance of some specific SM and Cer species in ileal efflux and feces, suggesting differential absorption and metabolization processes in the gut. CONCLUSION These data demonstrate that milk PL supplementation decreases atherogenic SM and Cer species associated with an improvement of cardiovascular risk markers. Our findings bring new insights on sphingolipid metabolism in the gastrointestinal tract, especially Cer as such signaling molecules potentially participating in the beneficial effect of milk PL. ClinicalTrials.gov, NCT02099032, NCT02146339.FUNDINGS. Agence Nationale de la Recherche, ANR-11-ALID-007-01; Regional Hospital Clinical Research Program (PHRCI-2014: VALOBAB, n°14-007); French Dairy Interbranch Organization (CNIEL); Groupe Lipides et Nutrition (GLN 2018-11-07), Hospices Civils de Lyon as sponsor.",2021,Milk PL decreased the concentration in chylomicrons of total SM (Pgroup < 0.0001) and of C24:1 Cer (Pgroup = 0.001).,"['n°14-007); French Dairy Interbranch Organization (CNIEL); Groupe Lipides et Nutrition', 'postmenopausal women', '58 postmenopausal women consumed daily a']","['Milk polar lipids', 'milk PL supplementation', 'cream cheese containing 0, 3 or 5 g of milk PL']","['serum atherogenic C24:1 Cer', 'total fecal Cer', 'total cholesterol', 'Postprandial metabolic explorations', 'LDL-C', 'cardiovascular risk markers']","[{'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0452795', 'cui_str': 'Cream cheese'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0007745', 'cui_str': 'Ceramides'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C1280903', 'cui_str': 'Exploration procedure'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",58.0,0.155452,Milk PL decreased the concentration in chylomicrons of total SM (Pgroup < 0.0001) and of C24:1 Cer (Pgroup = 0.001).,"[{'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Le Barz', 'Affiliation': 'Univ Lyon, CarMeN Laboratory, INSERM, INRAE, Université Claude Bernard Lyon 1, Pierre-Bénite, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Vors', 'Affiliation': 'Univ Lyon, CarMeN Laboratory, INSERM, INRAE, Université Claude Bernard Lyon 1, Pierre-Bénite, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Combe', 'Affiliation': 'Univ Lyon, CarMeN Laboratory, INSERM, INRAE, Université Claude Bernard Lyon 1, Pierre-Bénite, France.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Joumard-Cubizolles', 'Affiliation': 'Unité de Nutrition Humaine, Université Clermont Auvergne, UNH, INRAE, Clermont-Ferrand, France.'}, {'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Lecomte', 'Affiliation': 'Univ Lyon, CarMeN Laboratory, INSERM, INRAE, Université Claude Bernard Lyon 1, Pierre-Bénite, France.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Joffre', 'Affiliation': 'Institut des Corps Gras, ITERG, Canéjan, France.'}, {'ForeName': 'Michèle', 'Initials': 'M', 'LastName': 'Trauchessec', 'Affiliation': 'Unité Maladies Héréditaires du Métabolisme, Service de Biochimie et Biologi, Hospices Civils de Lyon, Bron, France.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Pesenti', 'Affiliation': 'Univ Lyon, CarMeN Laboratory, INSERM, INRAE, Université Claude Bernard Lyon 1, Pierre-Bénite, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Loizon', 'Affiliation': 'Univ Lyon, CarMeN Laboratory, INSERM, INRAE, Université Claude Bernard Lyon 1, Pierre-Bénite, France.'}, {'ForeName': 'Anne-Esther', 'Initials': 'AE', 'LastName': 'Breyton', 'Affiliation': 'Univ Lyon, CarMeN Laboratory, INSERM, INRAE, Université Claude Bernard Lyon 1, Pierre-Bénite, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Meugnier', 'Affiliation': 'Univ Lyon, CarMeN Laboratory, INSERM, INRAE, Université Claude Bernard Lyon 1, Pierre-Bénite, France.'}, {'ForeName': 'Karène', 'Initials': 'K', 'LastName': 'Bertrand', 'Affiliation': 'Institut des Corps Gras, ITERG, Canéjan, France.'}, {'ForeName': 'Jocelyne', 'Initials': 'J', 'LastName': 'Drai', 'Affiliation': 'Unité de Nutrition Endocrinologie Métabolisme, Service de Biochimie, Centre, Hospices Civils de Lyon, Pierre-Bénite, France.'}, {'ForeName': 'Chloé', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Univ Lyon, CarMeN Laboratory, INSERM, INRAE, Université Claude Bernard Lyon 1, Pierre-Bénite, France.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Durand', 'Affiliation': 'Univ Lyon, CarMeN Laboratory, INSERM, INRAE, Université Claude Bernard Lyon 1, Pierre-Bénite, France.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Cuerq', 'Affiliation': 'Unité de Nutrition Endocrinologie Métabolisme, Service de Biochimie, Centre, Hospices Civils de Lyon, Pierre-Bénite, France.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Gaborit', 'Affiliation': 'Dairy Products and Technologies, ACTALIA, Surgères, France.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Leconte', 'Affiliation': ""Institut Agro, STLO (Science et Technologie du Lait et de l'Œuf), INRAE, Rennes, France.""}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Bernalier-Donadille', 'Affiliation': 'INRAE, UMR MEDIS, Université Clermont Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Eddy', 'Initials': 'E', 'LastName': 'Cotte', 'Affiliation': 'Service de Chirurgie Digestive, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Pierre-Bénite, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Laville', 'Affiliation': 'Univ Lyon, CarMeN Laboratory, INSERM, INRAE, Université Claude Bernard Lyon 1, Pierre-Bénite, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Lambert-Porcheron', 'Affiliation': 'Centre de Recherche en Nutrition Humaine Rhône-Alpes, Pierre Bénite, France.'}, {'ForeName': 'Lemlih', 'Initials': 'L', 'LastName': 'Ouchchane', 'Affiliation': 'Unité de Biostatistique-Informatique Médicale, CHU Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Vidal', 'Affiliation': 'Univ Lyon, CarMeN Laboratory, INSERM, INRAE, Université Claude Bernard Lyon 1, Pierre-Bénite, France.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Malpuech-Brugère', 'Affiliation': 'Unité de Nutrition Humaine, Université Clermont Auvergne, UNH, INRAE, Clermont-Ferrand, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cheillan', 'Affiliation': 'Unité Maladies Héréditaires du Métabolisme, Service de Biochimie et Biologi, Hospices Civils de Lyon, Bron, France.'}, {'ForeName': 'Marie-Caroline', 'Initials': 'MC', 'LastName': 'Michalski', 'Affiliation': 'Univ Lyon, CarMeN Laboratory, INSERM, INRAE, Université Claude Bernard Lyon 1, Pierre-Bénite, France.'}]",JCI insight,['10.1172/jci.insight.146161'] 3974,33857010,Correction: Assessment of the Effectiveness of Identity-Based Public Health Announcements in Increasing the Likelihood of Complying With COVID-19 Guidelines: Randomized Controlled Cross-sectional Web-Based Study.,[This corrects the article DOI: .].,2021,[This corrects the article DOI: .].,['Complying With COVID-19 Guidelines'],['Identity-Based Public Health Announcements'],[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C0424215', 'cui_str': 'Sense of identity'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}]",[],,0.0432264,[This corrects the article DOI: .].,"[{'ForeName': 'Alexander S', 'Initials': 'AS', 'LastName': 'Dennis', 'Affiliation': 'Smith School of Business, University of Maryland, College Park, MD, United States.'}, {'ForeName': 'Patricia L', 'Initials': 'PL', 'LastName': 'Moravec', 'Affiliation': 'McCombs School of Business, University of Texas at Austin, Austin, TX, United States.'}, {'ForeName': 'Antino', 'Initials': 'A', 'LastName': 'Kim', 'Affiliation': 'Kelley School of Business, Indiana University, Bloomington, IN, United States.'}, {'ForeName': 'Alan R', 'Initials': 'AR', 'LastName': 'Dennis', 'Affiliation': 'Kelley School of Business, Indiana University, Bloomington, IN, United States.'}]",JMIR public health and surveillance,['10.2196/29603'] 3975,33856973,Mindfulness-based schema therapy and forgiveness therapy among women affected by infidelity: A randomized clinical trial.,"OBJECTIVE Infidelity causes mental health problems, family disruptions, rumination about events and changes in women's beliefs about the disloyal person. This study aimed to compare the effectiveness of mindfulness-based schema (MBS) therapy and forgiveness therapy in emotional responses, cognitive distortions and self-compassion of women affected by infidelity. Method: It was an experimental research with a pretest-posttest and follow-up design. Eighty-one women affected by infidelity were randomly assigned to two experimental groups and one control group. The experimental groups received interventions for ten 90-minute weekly sessions. Participants completed the questionnaires in the pretest, post-test and follow-up. Repeated measures analysis of variance was used for statistical analysis. Results: Both experimental groups were significantly different from the control group ( p <.01). Forgiveness therapy was more effective in emotional responses and self-compassion in the post-test ( p< .01) and follow-up ( p >.001) stages. MBS therapy was more effective in cognitive distortions in the post-test and follow-up stages ( p >.001). Participants of experimental groups were responders and satisfied with treatment and had a good therapeutic relationship. Conclusion: Given the type of problems faced by women affected by infidelity, forgiveness therapy and MBS therapy can be used to reduce mental sufferings and communication problems.",2021,MBS therapy was more effective in cognitive distortions in the post-test and follow-up stages ( p >.001).,"['Eighty-one women affected by infidelity', 'women affected by infidelity']","['MBS therapy', 'Mindfulness-based schema therapy and forgiveness therapy', 'mindfulness-based schema (MBS) therapy and forgiveness therapy']","['emotional responses and self-compassion', 'cognitive distortions', 'emotional responses, cognitive distortions and self-compassion']","[{'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C5200813', 'cui_str': 'Schema Therapy'}, {'cui': 'C0871753', 'cui_str': 'Forgiveness'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0030976', 'cui_str': 'Distortions, Perceptual'}]",81.0,0.0115401,MBS therapy was more effective in cognitive distortions in the post-test and follow-up stages ( p >.001).,"[{'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Raftar Aliabadi', 'Affiliation': 'Faculty of Basic Sciences, Department of Psychological Sciences, Neyshabur Branch, Islamic Azad University, Neyshabur, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Shareh', 'Affiliation': 'Faculty of Letters & Humanities, Department of Educational Science, Hakim Sabzevari University, Sabzevar, Iran.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2021.1913294'] 3976,33856964,A Phase-2 NIH-Sponsored Randomized Clinical Trial of Rituximab in SSC-PAH Did Not Reach Significance for its Endpoints: End of Story? Not so Fast!,,2021,,[],['Rituximab'],[],[],"[{'cui': 'C0393022', 'cui_str': 'rituximab'}]",[],,0.244998,,"[{'ForeName': 'Yongneng', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'University of Alberta Faculty of Medicine and Dentistry, 12357, Edmonton, Alberta, Canada.'}, {'ForeName': 'Evangelos D', 'Initials': 'ED', 'LastName': 'Michelakis', 'Affiliation': 'University of Alberta, 3158, Edmonton, Alberta, Canada; em2@ualberta.ca.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202103-0612ED'] 3977,33856860,Influence of Aerobic Exercise Volume on Postconcussion Symptoms.,"BACKGROUND Aerobic exercise has emerged as a useful treatment to improve outcomes among individuals who experience a concussion. However, compliance with exercise recommendations and the effect of exercise volume on symptom recovery require further investigation. PURPOSE To examine (1) if an 8-week aerobic exercise prescription, provided within 2 weeks of concussion, affects symptom severity or exercise volume; (2) whether prescription adherence, rather than randomized group assignment, reflects the actual effect of aerobic exercise in postconcussion recovery; and (3) the optimal volume of exercise associated with symptom resolution after 1 month of study. STUDY DESIGN Cohort study; Level of evidence, 2. METHODS Individuals randomized to an exercise intervention (n = 17; mean age, 17.2 ± 2.0 years; 41% female; initially tested a mean of 11.3 ± 2.8 days after injury) or standard of care (n = 20; mean age, 16.8 ± 2.2 years; 50% female; initially tested a mean of 10.7 ± 3.2 days after injury) completed an aerobic exercise test within 14 days of injury. They returned for assessments 1 month and 2 months after the initial visit. The aerobic exercise group was instructed to exercise 5 d/wk, 20 min/d (100 min/wk), at a target heart rate based on an exercise test at the initial visit. Participants reported their exercise volume each week over the 8-week study period and reported symptoms at each study visit (initial, 1 month, 2 months). Because of low compliance in both groups, there was no difference in the volume of exercise between the 2 groups. RESULTS There were no significant symptom severity differences between the intervention and standard-of-care groups at the initial (median Post-Concussion Symptom Inventory, 15 [interquartile range = 10, 42] vs 20 [11, 35.5]; P = .26), 1-month (4 [0, 28] vs 5.5 [0.5, 21.5]; P = .96), or 2-month (6.5 [0, 27.5] vs 0 [0, 4]; P = .11) study visits. Exercise volume was similar between groups (median, 115 [54, 225] vs 88 [28, 230] min/wk for exercise intervention vs standard of care; P = .52). Regardless of group, those who exercised <100 min/wk reported significantly higher symptom severity at the 1-month evaluation compared with those who exercised ≥100 min/wk (median, 1.5 [0, 7.5] vs 12 [4, 28]; P = .03). Exercising ≥160 min/wk successfully discriminated between those with and those without symptoms 1 month after study commencement (classification accuracy, 81%; sensitivity, 90%; specificity, 78%). CONCLUSION Greater exercise volume was associated with lower symptom burden after 1 month of study, and an exercise volume >160 min/wk in the first month of the study was the threshold associated with symptom resolution after the first month of the study. Because our observation on the association between exercise volume and symptom level is a retrospective and secondary outcome, it is possible that participants who were feeling better were more likely to exercise more, rather than the exercise itself driving the reduction in symptom severity.",2021,"There were no significant symptom severity differences between the intervention and standard-of-care groups at the initial (median Post-Concussion Symptom Inventory, 15 [interquartile range = 10, 42] vs 20 [11, 35.5]; P = .26), 1-month (4 [0, 28] vs 5.5 [0.5, 21.5]; P = .96), or 2-month (6.5 [0, 27.5] vs 0","['individuals who experience a concussion', 'n = 17; mean age, 17.2 ± 2.0 years; 41% female; initially tested a mean of 11.3 ± 2.8 days after injury) or standard of care (n = 20; mean age, 16.8 ± 2.2 years; 50% female; initially tested a mean of 10.7 ± 3.2 days after injury) completed an']","['aerobic exercise', 'exercise intervention', 'aerobic exercise test', 'Aerobic Exercise Volume', 'Aerobic exercise']","['Greater exercise volume', 'volume of exercise', 'Postconcussion Symptoms', 'Exercise volume', 'symptom resolution', 'symptom severity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C4517591', 'cui_str': '16.8'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C5191365', 'cui_str': '10.7'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]","[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}]",,0.0669307,"There were no significant symptom severity differences between the intervention and standard-of-care groups at the initial (median Post-Concussion Symptom Inventory, 15 [interquartile range = 10, 42] vs 20 [11, 35.5]; P = .26), 1-month (4 [0, 28] vs 5.5 [0.5, 21.5]; P = .96), or 2-month (6.5 [0, 27.5] vs 0","[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Howell', 'Affiliation': ""Sports Medicine Center, Children's Hospital Colorado, Aurora, Colorado, USA.""}, {'ForeName': 'Danielle L', 'Initials': 'DL', 'LastName': 'Hunt', 'Affiliation': 'The Micheli Center for Sports Injury Prevention, Waltham, Massachusetts, USA.'}, {'ForeName': 'Stacey E', 'Initials': 'SE', 'LastName': 'Aaron', 'Affiliation': 'Cerebrovascular Research Laboratory, Spaulding Rehabilitation Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Meehan', 'Affiliation': 'The Micheli Center for Sports Injury Prevention, Waltham, Massachusetts, USA.'}, {'ForeName': 'Can Ozan', 'Initials': 'CO', 'LastName': 'Tan', 'Affiliation': 'Cerebrovascular Research Laboratory, Spaulding Rehabilitation Hospital, Boston, Massachusetts, USA.'}]",The American journal of sports medicine,['10.1177/03635465211005761'] 3978,33856856,The alliance-outcome association in the treatment of adolescent depression.,"A growing body of research has consistently demonstrated a relationship between alliance and treatment outcomes in youth psychotherapy. However, previous research often suffered methodological issues that prevented detailed investigation of temporal relationships between alliance and symptomatology. The current study explored the directions of effect between alliance and outcome by examining the associations between early alliance and subsequent outcome while controlling for patients' baseline severity and prior symptom change. It also examined potential moderators of this association. Data were drawn from the IMPACT study, a randomized controlled trial comparing cognitive-behavioral therapy and short-term psychoanalytic psychotherapy versus a brief psychosocial intervention in the treatment of adolescent depression. Adolescents (N = 224) and therapist (n = 139) rated the alliance 6 weeks after randomization. Depression severity and overall psychopathology were assessed at baseline, 6, 12, 36, 52, and 86 weeks after randomization. Patients' age, gender, baseline depression severity, conduct disorder symptoms, and treatment type were examined as potential moderators of the alliance-outcome association. Data were analyzed using multilevel models. Findings suggested that higher early alliance ratings were associated with subsequent symptom reduction, even after controlling for prior symptom change and baseline severity. There was some evidence that the strength of this association was strongest in cognitive-behavioral therapy, weaker in short-term psychoanalytic psychotherapy, and statistically indistinguishable from zero in brief psychosocial intervention. These findings suggest that early therapeutic alliance with adolescents may influence subsequent outcome independent of prior symptom change and initial severity but that the effect of the alliance on outcome might vary across treatment types. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"Depression severity and overall psychopathology were assessed at baseline, 6, 12, 36, 52, and 86 weeks after randomization.","['Adolescents (N = 224) and therapist (n = 139', 'adolescent depression']",['cognitive-behavioral therapy and short-term psychoanalytic psychotherapy versus a brief psychosocial intervention'],['Depression severity and overall psychopathology'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}]",,0.128409,"Depression severity and overall psychopathology were assessed at baseline, 6, 12, 36, 52, and 86 weeks after randomization.","[{'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Cirasola', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Midgley', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fonagy', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Impact Consortium', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Martin', 'Affiliation': 'Department of Applied Health Research.'}]","Psychotherapy (Chicago, Ill.)",['10.1037/pst0000366'] 3979,33856821,Correlates of the nicotine metabolite ratio in Alaska Native people who smoke cigarettes.,"Research on nicotine metabolism has primarily focused on white adults. This study examined associations between nicotine metabolism, tobacco use, and demographic characteristics among Alaska Native adults who smoke cigarettes. Participants ( N = 244) were Alaska Native adults who smoked and who provided a plasma sample at baseline (70.1%) or follow-up (29.9%) of a randomized controlled trial of a cardiovascular risk behavior intervention. At baseline, participants self-reported age, sex, Alaska Native heritage, cigarettes per day, time to first cigarette upon wakening, menthol use, perceived difficulty staying quit, tobacco withdrawal symptoms, and past-month tobacco product use, binge drinking, and cannabis use. At 3-, 6-, 12-, and 18-month follow-ups, participants self-reported 7-day point prevalence abstinence from smoking. Height and weight were measured to calculate body mass index (BMI). Participants' nicotine metabolite ratio (NMR), calculated as the ratio of plasma cotinine and trans-3' hydroxycotinine, was log-transformed. The sample (52.0% male, age M = 47.0 years [ SD = 13.8], 60.3% of Inupiaq heritage) averaged 12.5 cigarettes per day ( SD = 10.5); 64.0% smoked within 30 min of wakening. NMR was not significantly associated with age, sex, Alaska Native heritage, BMI, cigarettes per day, time to first cigarette upon wakening, menthol use, perceived difficulty staying quit, past-month dual tobacco product use, withdrawal symptoms, past-month binge drinking, past-month cannabis use, or abstinence from smoking (all p -values > .050). Characteristics that relate to NMR in Alaska Native adults may differ from those typically identified among white adults. Specifically, results may suggest that Alaska Native adults with slower nicotine metabolism do not titrate their nicotine intake when smoking. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"NMR was not significantly associated with age, sex, Alaska Native heritage, BMI, cigarettes per day, time to first cigarette upon wakening, menthol use, perceived difficulty staying quit, past-month dual tobacco product use, withdrawal symptoms, past-month binge drinking, past-month cannabis use, or abstinence from smoking (all p -values > .050).","['Alaska Native adults who smoke cigarettes', 'Participants ( N = 244) were Alaska Native adults who smoked and who provided a plasma sample at baseline (70.1%) or follow-up (29.9', 'white adults', 'Alaska Native people who smoke cigarettes', 'The sample (52.0% male, age M = 47.0 years [ SD = 13.8], 60.3% of Inupiaq heritage) averaged 12.5 cigarettes per day ( SD = 10.5); 64.0% smoked within 30 min of wakening']","['nicotine metabolite ratio', 'cardiovascular risk behavior intervention']","['NMR', 'age, sex, Alaska Native heritage, BMI, cigarettes per day, time to first cigarette upon wakening, menthol use, perceived difficulty staying quit, past-month dual tobacco product use, withdrawal symptoms, past-month binge drinking, past-month cannabis use, or abstinence from smoking', ""nicotine metabolite ratio (NMR), calculated as the ratio of plasma cotinine and trans-3' hydroxycotinine"", 'Height and weight']","[{'cui': 'C0682125', 'cui_str': 'Native Alaskians'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0221134', 'cui_str': 'Blood group antigen M'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517561', 'cui_str': '13.8'}, {'cui': 'C1555620', 'cui_str': 'Inupiaq language'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0456693', 'cui_str': '/30 min'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0682125', 'cui_str': 'Native Alaskians'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0010194', 'cui_str': 'Cotinine'}, {'cui': 'C0063125', 'cui_str': 'Trans-3-hydroxycotinine'}, {'cui': 'C0424638', 'cui_str': 'Height and weight'}]",244.0,0.112022,"NMR was not significantly associated with age, sex, Alaska Native heritage, BMI, cigarettes per day, time to first cigarette upon wakening, menthol use, perceived difficulty staying quit, past-month dual tobacco product use, withdrawal symptoms, past-month binge drinking, past-month cannabis use, or abstinence from smoking (all p -values > .050).","[{'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'Vogel', 'Affiliation': 'Stanford Prevention Research Center.'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Benowitz', 'Affiliation': 'Clinical Pharmacology Program.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Skan', 'Affiliation': 'Cardiology Department.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Schnellbaecher', 'Affiliation': 'Cardiology Department.'}, {'ForeName': 'Judith J', 'Initials': 'JJ', 'LastName': 'Prochaska', 'Affiliation': 'Stanford Prevention Research Center.'}]",Experimental and clinical psychopharmacology,['10.1037/pha0000461'] 3980,33861468,"The effect of nursing interventions to instill hope on the internalized stigma, hope, and quality of life levels in patients With schizophrenia.","PURPOSE This study was conducted to determine the effect of nursing interventions to instill hope on the internalized stigma, hope, and quality of life. METHODS The study was conducted as a quasi-experimental study with the experimental and control groups and repeated measurements. The data were collected using the Personal Information Form, Internalized Stigma Scale in Mental Illnesses (ISMI), Herth Hope Index (HHS), and Quality of Life Scale (QLS) for schizophrenia patients. RESULTS The difference between ISMI, HHS, and QLS posttest and follow-up test average scores was found to be statistically significant between the experimental and control groups. CONCLUSION It was determined that nursing interventions aimed at improving hope effectively decreased the internalized stigmatization level of patients with schizophrenia and increased hope and life quality levels.",2021,It was determined that nursing interventions aimed at improving hope effectively decreased the internalized stigmatization level of patients with schizophrenia and increased hope and life quality levels.,['patients With schizophrenia'],['nursing interventions'],"['ISMI, HHS, and QLS posttest and follow-up test average scores', 'hope and life quality levels', 'Personal Information Form, Internalized Stigma Scale in Mental Illnesses (ISMI), Herth Hope Index (HHS), and Quality of Life Scale (QLS', 'internalized stigma, hope, and quality of life levels', 'internalized stigma, hope, and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0041711', 'cui_str': 'United States. Dept. of Health and Human Services'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2983694', 'cui_str': 'Personally Identifiable Information'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0222803,It was determined that nursing interventions aimed at improving hope effectively decreased the internalized stigmatization level of patients with schizophrenia and increased hope and life quality levels.,"[{'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Öztürk', 'Affiliation': 'Department of Psychiatric Nursing, Faculty of Nursing, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'Şahi N Altun', 'Affiliation': 'Department of Psychiatric Nursing, Faculty of Nursing, Ataturk University, Erzurum, Turkey.'}]",Perspectives in psychiatric care,['10.1111/ppc.12800'] 3981,33861467,The effects of therapeutic touch on spiritual care and sleep quality in patients receiving palliative care.,"PURPOSE This study was conducted to investigate the effect of therapeutic touch (TT) on spiritual care and sleep quality in patients receiving palliative care. DESIGN AND METHODS The research was conducted on 73 inpatients receiving palliative care in a training and research hospital. Data were collected with Socio-Demographic Status Questionnaire, Spirituality and Spiritual Care Rating Scale (SSCRS), Pittsburgh Sleep Quality Index (PSQI). FINDINGS As a result of this study, a statistically significant difference was found between the intervention and control group SSCRS (Z = -7.356 p = 0.000) and PSQI (Z = -7.292 p = 0.000) in post-test data after 4 weeks of TT application. PRACTICE IMPLICATIONS The results revealed that TT application has a positive impact on spiritual care and sleep quality of the patients.",2021,"As a result of this study, a statistically significant difference was found between the intervention and control group SSCRS (Z = -7.356 p = 0.000) and PSQI (Z = -7.292 p = 0.000) in post-test data after 4 weeks of TT application. ","['patients receiving palliative care', '73 inpatients receiving palliative care in a training and research hospital']",['therapeutic touch (TT'],"['Socio-Demographic Status Questionnaire, Spirituality and Spiritual Care Rating Scale (SSCRS), Pittsburgh Sleep Quality Index (PSQI', 'PSQI', 'spiritual care and sleep quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0152054', 'cui_str': 'Touch'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0237104', 'cui_str': 'Spirituality'}, {'cui': 'C0150355', 'cui_str': 'Spiritual support'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",73.0,0.0219161,"As a result of this study, a statistically significant difference was found between the intervention and control group SSCRS (Z = -7.356 p = 0.000) and PSQI (Z = -7.292 p = 0.000) in post-test data after 4 weeks of TT application. ","[{'ForeName': 'Kevser S', 'Initials': 'KS', 'LastName': 'Ünal Aslan', 'Affiliation': 'Fundamentals of Nursing Department, Faculty of Health Sciences, Osmaniye Korkut Ata University, Osmaniye, Turkey.'}, {'ForeName': 'Funda', 'Initials': 'F', 'LastName': 'Çetinkaya', 'Affiliation': 'Department of Surgical Nursing, Faculty of Health Sciences, Aksaray University, Aksaray, Turkey.'}]",Perspectives in psychiatric care,['10.1111/ppc.12801'] 3982,33861459,Protective Effects of Intravenous Magnesium Sulfate in Stroke Patients Receiving Amiodarone: A Randomized Controlled Trial.,"Anti-arrhythmic agents, like amiodarone, interfere at different stages of the ischemic stroke. However, amiodarone was accompanied with immunological pulmonary complications and adverse neurological effects. We hypothesize that magnesium sulfate in combination with amiodarone holds promise for stroke treatment. Thirty-six patients with confirmed diagnosis of ischemic stroke and atrial fibrillation who received bolus amiodarone were randomly assigned to magnesium sulfate every 24 h or similar volume of normal saline (as placebo) for 5 days. Various severity test scores were used to evaluate the symptoms. Routing biochemistry were also measured at days 1 and 5. Treatment with MgSO4 results in a significant reduction in serum levels of NGAL, Hb, T.Bill, IL-6, IL-8, SNSE, S100B, EGF, PAF, CRP and IgG. Also, MgSO4 treatment significantly improved the RASS, Candida, SOFA, NIHSS and APACHE scores. Moreover, reduction of IL-6, IL-8, SNSE, EGF and APACHE score and increase in RASS score were significantly higher in MgSO4 group compared with placebo. Intravenous administration of MgSO4 in amiodarone-treated stroke patients improved the inflammatory, immunological and neurological indicators and reduced disability in ICU-admitted AIS patients, suggesting that this treatment scheme may prevent amiodarone-induced complications in these patients.",2021,"Treatment with MgSO4 results in a significant reduction in serum levels of NGAL, Hb, T.Bill, IL-6, IL-8, SNSE, S100B, EGF, PAF, CRP and IgG.","['Thirty-six patients with confirmed diagnosis of ischemic stroke and atrial fibrillation who received bolus', 'Stroke Patients Receiving']","['MgSO4', 'magnesium sulfate every 24\xa0h or similar volume of normal saline (as placebo', 'Intravenous Magnesium Sulfate', 'amiodarone', 'magnesium sulfate', 'placebo', 'Amiodarone']","['RASS, Candida, SOFA, NIHSS and APACHE scores', 'immunological pulmonary complications and adverse neurological effects', 'inflammatory, immunological and neurological indicators and reduced disability', 'reduction of IL-6, IL-8, SNSE, EGF and APACHE score and increase in RASS score', 'serum levels of NGAL, Hb, T.Bill, IL-6, IL-8, SNSE, S100B, EGF, PAF, CRP and IgG']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002598', 'cui_str': 'Amiodarone'}]","[{'cui': 'C0006836', 'cui_str': 'Candida'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0243030', 'cui_str': 'Acute physiology and chronic health evaluation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0242275', 'cui_str': 'Epidermal Growth Factor'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0215955', 'cui_str': 'LCN2 protein, human'}, {'cui': 'C0032172', 'cui_str': 'Platelet activating factor'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}]",36.0,0.049907,"Treatment with MgSO4 results in a significant reduction in serum levels of NGAL, Hb, T.Bill, IL-6, IL-8, SNSE, S100B, EGF, PAF, CRP and IgG.","[{'ForeName': 'Yunes', 'Initials': 'Y', 'LastName': 'Panahi', 'Affiliation': 'Pharmacotherapy Department, School of Pharmacy, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Mojtahedzadeh', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Atabak', 'Initials': 'A', 'LastName': 'Najafi', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Faculty of Medicine, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Gheini', 'Affiliation': 'Department of Neurosurgery and Neurology, Sina Hospital, Tehran University, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Abdollahi', 'Affiliation': 'Department of Toxicology and Pharmacology, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Sharifzadeh', 'Affiliation': 'Department of Toxicology and Pharmacology, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Arezoo', 'Initials': 'A', 'LastName': 'Ahmadi', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Faculty of Medicine, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shiva', 'Initials': 'S', 'LastName': 'Ganjali', 'Affiliation': 'Department of Medical Biotechnology and Nanotechnology, Faculty of Medicine, Mashhad University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyyed Mahdi', 'Initials': 'SM', 'LastName': 'Rajaee', 'Affiliation': 'Gastrointestinal Pharmacology Interest Group (GPIG), Universal Scientific Education and Research Network (USERN), Tehran, Iran.'}, {'ForeName': 'George E', 'Initials': 'GE', 'LastName': 'Barreto', 'Affiliation': 'Department of Biological Sciences, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'Amirhossein', 'Initials': 'A', 'LastName': 'Sahebkar', 'Affiliation': 'Applied Biomedical Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. sahebkara@mums.ac.ir.'}]",Advances in experimental medicine and biology,['10.1007/978-3-030-64872-5_28'] 3983,33861441,Effect of Curcumin on Severity of Functional Dyspepsia: a Triple Blinded Clinical Trial.,"BackgroundFunctional dyspepsia is the main cause of upper abdominal discomfort affecting 5-10% of the world population. Despite various therapeutic approaches, up to 50% of patients with functional dyspepsia seek alternative treatments. In the present study we evaluated the effect of curcumin supplementation along with famotidine therapy on severity of functional dyspepsia. A total of 75 patients with functional dyspepsia according to Rome III criteria were allocated into intervention (N = 39) or control (N = 36) groups. The intervention group was treated with a combination of 500 mg curcumin and 40 mg famotidine daily for 1 month. The control group received placebo and 40 mg famotidine. Severity of dyspepsia symptoms was determined using the Hong Kong questionnaire at baseline, after the 1 month treatment and after a 1 month follow-up. The presence of H. pylori antigens in the stool samples was also investigated in all subjects. No significant difference was observed between intervention and control groups in biochemical indices, severity of dyspepsia and rate of H. pylori infection. A significant decrease was observed in severity of dyspepsia (p < 0.001) and rate of H. pylori infection (p = 0.004) immediately after the treatment and follow-up in the curcumin intervention group. This study indicated that curcumin therapy could be a favorable supplementation in the symptom management of functional dyspepsia. Moreover, curcumin could help efficient eradication of H. pylori in these patients.",2021,"No significant difference was observed between intervention and control groups in biochemical indices, severity of dyspepsia and rate of H. pylori infection.",['75 patients with functional dyspepsia according to Rome III criteria'],"['placebo and 40 mg famotidine', 'curcumin and 40 mg famotidine', 'curcumin therapy', 'curcumin supplementation', 'famotidine therapy', 'Curcumin']","['presence of H. pylori antigens', 'rate of H. pylori infection', 'Severity of dyspepsia symptoms', 'biochemical indices, severity of dyspepsia and rate of H. pylori infection', 'severity of functional dyspepsia', 'Severity of Functional Dyspepsia', 'severity of dyspepsia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015620', 'cui_str': 'Famotidine'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}]",75.0,0.023477,"No significant difference was observed between intervention and control groups in biochemical indices, severity of dyspepsia and rate of H. pylori infection.","[{'ForeName': 'Yunes', 'Initials': 'Y', 'LastName': 'Panahi', 'Affiliation': 'Pharmacotherapy Department, Faculty of Pharmacy, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Karbasi', 'Affiliation': 'Gastroenterology and Hepatology Department, Baqiyatallah Research Center for Gastroenterology and Liver Diseases, Baqiyatallah University of Medical Sciences, Tehran, Iran. ashraf.karbasi@yahoo.com.'}, {'ForeName': 'Ghasem', 'Initials': 'G', 'LastName': 'Valizadegan', 'Affiliation': 'Baqiyatallah Research Center for Gastroenterology and Liver Disease, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nayyereh', 'Initials': 'N', 'LastName': 'Ostadzadeh', 'Affiliation': 'Baqiyatallah Hospital, Tehran, Iran.'}, {'ForeName': 'Sara Saffar', 'Initials': 'SS', 'LastName': 'Soflaei', 'Affiliation': 'School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Tannaz', 'Initials': 'T', 'LastName': 'Jamialahmadi', 'Affiliation': 'Department of Food Science and Technology, Quchan Branch, Islamic Azad University, Quchan, Iran.'}, {'ForeName': 'Muhammed', 'Initials': 'M', 'LastName': 'Majeed', 'Affiliation': 'Sabinsa Corporation, East Windsor, NJ, USA.'}, {'ForeName': 'Amirhossein', 'Initials': 'A', 'LastName': 'Sahebkar', 'Affiliation': 'Applied Biomedical Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. sahebkara@mums.ac.ir.'}]",Advances in experimental medicine and biology,['10.1007/978-3-030-64872-5_10'] 3984,33861440,Therapeutic Effect of Curcumin in Women with Polycystic Ovary Syndrome Receiving Metformin: A Randomized Controlled Trial.,"Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility, for which the insulin sensitizer metformin has been used therapeutically. It has been shown that curcumin also exhibits insulin-sensitizing properties. Given that metformin acts as an ovulation inducing agent and both curcumin and metformin can reduce insulin resistance, the aim of the current study was to evaluate the effect of metformin with and without curcumin nanomicelles in the treatment of women with polycystic ovary syndrome. This clinical trial was conducted on 100 women with PCOS, diagnosed according to the Rotterdam criteria, who were sequentially recruited and randomly divided into two groups (n = 50 each). Group 1 received 500 mg metformin three times daily and group 2 received 80 mg/day capsule of curcumin nanomicelle and 500 mg metformin three times a day for 3 months. After collecting fasting blood samples, biochemical parameters including triglycerides, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), total cholesterol, plasma glucose, alanine amino transferase (ALT) and aspartate aminotransferase (AST) were evaluated based on enzymatic methods. Hormonal parameters were assessed using immunoassay kits. Insulin resistance (HOMA-IR) and insulin-sensitivity check index (QUICKI) were also assessed. After treatment, fasting insulin, HOMA-IR, and total testosterone in group 2 were significantly lower than those in group 1 (p < 0.05). Post-treatment LDL-C levels in groups 1 and 2 were 117.9 ± 24 and 91.12 ± 19.46 mg/dL, respectively (p < 0.01). In addition, HDL-C levels were increased with curcumin (group 1: 38.1 ± 4.36 mg/dL; group 2: 44.12 ± 7.3 mg/dL, p < 0.05). Total cholesterol was decreased with curcumin level (group 1: 207.9 ± 39.84 mg/dL; group 2; 159.7 ± 48.43 mg/dL, p < 0.05), with a decrease in triglycerides levels (group 1: 141.6 ± 9.57; group 2: 97.5 ± 8.8 mg/dL, p < 0.01). This study showed that curcumin has a synergistic effect with metformin in the improvement of insulin resistance and lipid profile in patients with PCOS. Therefore, the combined use of metformin and curcumin may have therapeutic utility in patients with PCOS.",2021,Total cholesterol was decreased with curcumin level (group 1: 207.9 ± 39.84 ,"['Women with Polycystic Ovary Syndrome', '100 women with PCOS, diagnosed\xa0according to the Rotterdam criteria', 'Polycystic ovary syndrome\xa0(PCOS', 'groups 1 and 2 were 117.9\xa0±', 'women with polycystic ovary syndrome', 'patients with PCOS']","['Metformin', 'metformin three times daily and group 2 received 80\xa0mg/day capsule of curcumin nanomicelle and 500 mg metformin', 'metformin', 'metformin and curcumin', 'curcumin', 'Curcumin']","['fasting insulin, HOMA-IR, and total testosterone', 'triglycerides levels', 'HDL-C levels', 'triglycerides, high-density lipoprotein cholesterol\xa0(HDL-C), low-density lipoprotein cholesterol\xa0(LDL-C), total\xa0cholesterol, plasma glucose, alanine amino transferase (ALT) and aspartate aminotransferase (AST', 'insulin resistance and lipid profile', 'Total cholesterol', 'Insulin resistance (HOMA-IR) and insulin-sensitivity check index (QUICKI']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C3816747', 'cui_str': '500'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0020980', 'cui_str': 'Immunoassay method'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0202227', 'cui_str': 'Testosterone measurement, total'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0057041', 'cui_str': 'D-amino-acid transaminase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",100.0,0.0317194,Total cholesterol was decreased with curcumin level (group 1: 207.9 ± 39.84 ,"[{'ForeName': 'Seyed Mojtaba', 'Initials': 'SM', 'LastName': 'Sohrevardi', 'Affiliation': 'Pharmaceutical Sciences Research Center, Faculty of Pharmacy, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Behrooz', 'Initials': 'B', 'LastName': 'Heydari', 'Affiliation': 'Pharmaceutical Sciences Research Center, Faculty of Pharmacy, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Mahmoud Reza', 'Initials': 'MR', 'LastName': 'Azarpazhooh', 'Affiliation': 'Department of Clinical Neurological Sciences, University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Teymourzadeh', 'Affiliation': 'Pharmaceutical Sciences Research Center, Faculty of Pharmacy, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Luis E', 'Initials': 'LE', 'LastName': 'Simental-Mendía', 'Affiliation': 'Biomedical Research Unit, Mexican Social Security Institute, Durango, Mexico.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Atkin', 'Affiliation': 'Weill Cornell Medicine Qatar, Doha, Qatar.'}, {'ForeName': 'Amirhossein', 'Initials': 'A', 'LastName': 'Sahebkar', 'Affiliation': 'Applied Biomedical Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Karimi-Zarchi', 'Affiliation': 'Department of Gynecology and Obstetrics, Iran University of Medical Sciences, Tehran, Iran. drkarimi2001@yahoo.com.'}]",Advances in experimental medicine and biology,['10.1007/978-3-030-64872-5_9'] 3985,33861434,"The Effect of Curcumin Phytosome on the Treatment of Patients with Non-alcoholic Fatty Liver Disease: A Double-Blind, Randomized, Placebo-Controlled Trial.","Non-alcoholic fatty liver disease (NAFLD) is a global health problem with increasing prevalence among overweight and obese patients. It is strongly associated with conditions of insulin resistance including type 2 diabetes mellitus (T2DM) and obesity. It has detrimental consequences ranged from simple steatosis to irreversible hepatic fibrosis and cirrhosis. Curcumin is a dietary polyphenol with potential effect in improving NAFLD. Therefore, the aim of this trial was to examine the effect of curcumin supplementation on various aspects of NAFLD. In this trial, a total number of 80 patients were randomised to receive either curcumin at 250 mg daily or placebo for 2 months. Lipid profiles, hepatic enzymes, anthropometric indices and hepatic fat mass were assessed at the baseline and the end of the trial, and compared within the groups. The grade of hepatic steatosis, and serum aspartate aminotransferase (AST) levels were significantly reduced in the curcumin group (p = 0.015 and p = 0.007, respectively) compared to the placebo. There was also a significant reduction in high density lipoprotein (HDL) levels and anthropometric indices in both groups with no significant differences between the two groups. Low dose phospholipid curcumin supplementation each day for 2 months showed significant reduction in hepatic steatosis and enzymes in patients with NAFLD compared to placebo. Further studies of longer duration and higher dosages are needed to assess its effect on other parameters of NAFLD including cardiovascular risk.",2021,"The grade of hepatic steatosis, and serum aspartate aminotransferase (AST) levels were significantly reduced in the curcumin group (p = ","['total number of 80 patients', 'overweight and obese patients', 'Patients with Non-alcoholic Fatty Liver Disease']","['curcumin at 250 mg daily or placebo', 'curcumin supplementation', 'placebo', 'Placebo', 'Curcumin Phytosome']","['Lipid profiles, hepatic enzymes, anthropometric indices and hepatic fat mass', 'grade of hepatic steatosis, and serum aspartate aminotransferase (AST) levels', 'hepatic steatosis and enzymes', 'high density lipoprotein (HDL) levels and anthropometric indices']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}]","[{'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0428321', 'cui_str': 'Measurement of liver enzyme'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0428339', 'cui_str': 'Aspartate transaminase level'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.610154,"The grade of hepatic steatosis, and serum aspartate aminotransferase (AST) levels were significantly reduced in the curcumin group (p = ","[{'ForeName': 'Seyed Reza', 'Initials': 'SR', 'LastName': 'Mirhafez', 'Affiliation': 'Noncommunicable Diseases Research Center, Neyshabur University of Medical Sciences, Neyshabur, Iran. mirhafez@nums.ac.ir.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Azimi-Nezhad', 'Affiliation': 'Noncommunicable Diseases Research Center, Neyshabur University of Medical Sciences, Neyshabur, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Dehabeh', 'Affiliation': 'Noncommunicable Diseases Research Center, Neyshabur University of Medical Sciences, Neyshabur, Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Hariri', 'Affiliation': 'Noncommunicable Diseases Research Center, Neyshabur University of Medical Sciences, Neyshabur, Iran.'}, {'ForeName': 'Ronika Danesh', 'Initials': 'RD', 'LastName': 'Naderan', 'Affiliation': 'Noncommunicable Diseases Research Center, Neyshabur University of Medical Sciences, Neyshabur, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Movahedi', 'Affiliation': 'Department of Anesthesia and Operating Room Nursing, Neyshabur University of Medical Sciences, Neyshabur, Iran.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Abdalla', 'Affiliation': 'Academic Diabetes, Endocrinology and Metabolism, Hull York Medical School, University of Hull, Hull, UK.'}, {'ForeName': 'Thozhukat', 'Initials': 'T', 'LastName': 'Sathyapalan', 'Affiliation': 'Academic Diabetes, Endocrinology and Metabolism, Hull York Medical School, University of Hull, Hull, UK.'}, {'ForeName': 'Amirhossein', 'Initials': 'A', 'LastName': 'Sahebkar', 'Affiliation': 'Applied Biomedical Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. sahebkara@mums.ac.ir.'}]",Advances in experimental medicine and biology,['10.1007/978-3-030-64872-5_3'] 3986,33861432,"The Effect of Curcumin Supplementation on Pulse Wave Velocity in Patients with Metabolic Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial.","Cardiovascular disease is a leading cause of death in many societies. Arterial stiffness is an initial sign of structural and functional changes in the arterial wall. Pulse wave velocity (PWV) is the gold standard for non-invasive evaluation of aortic stiffness and a modifiable cardiovascular risk factor. Curcumin is a major component of turmeric with known anti-inflammatory and anti-oxidative effects. Since arterial stiffness is affected by inflammation and oxidative stress, it may be improved by curcumin supplementation. The purpose of this clinical trial was to investigate the potential effects of curcumin on improving arterial stiffness in patients with metabolic syndrome. This placebo-controlled, double-blind, randomized clinical trial was conducted among metabolic syndrome patients. Sixty-six eligible individuals were randomly assigned to active intervention or control groups. The active intervention group received curcumin supplement at a dose of 500 mg daily for 12 weeks, whereas the control group received placebo capsule. Physical activity, daily dietary energy intake, anthropometric body composition, and biochemical hemodynamic and arterial stiffness parameters were evaluated at baseline and at the end of the study. Body weight decreased significantly in the curcumin group compared to placebo. Also, curcumin intervention improved PWV, which remained significant after adjustment for potential confounding factors (p = 0.011). The current clinical trial demonstrated that daily intake of 500 mg of curcumin for 12 weeks can lead to the improvement of arterial stiffness and weight management among subjects with metabolic syndrome.",2021,"Also, curcumin intervention improved PWV, which remained significant after adjustment for potential confounding factors (p = 0.011).","['Patients with Metabolic Syndrome', 'metabolic syndrome patients', 'subjects with metabolic syndrome', 'Sixty-six eligible individuals', 'patients with metabolic syndrome']","['Curcumin Supplementation', 'placebo', 'curcumin supplement', 'Placebo', 'curcumin', 'placebo capsule']","['arterial stiffness', 'Physical activity, daily dietary energy intake, anthropometric body composition, and biochemical hemodynamic and arterial stiffness parameters', 'arterial stiffness and weight management', 'Pulse Wave Velocity', 'PWV', 'Pulse wave velocity (PWV', 'Body weight']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",,0.243295,"Also, curcumin intervention improved PWV, which remained significant after adjustment for potential confounding factors (p = 0.011).","[{'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Alidadi', 'Affiliation': 'Department of Nutrition, Faculty of medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Amirhossein', 'Initials': 'A', 'LastName': 'Sahebkar', 'Affiliation': 'Applied Biomedical Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Eslami', 'Affiliation': ""Polish Mother's Memorial Hospital Research Institute (PMMHRI), Lodz, Poland.""}, {'ForeName': 'Farveh', 'Initials': 'F', 'LastName': 'Vakilian', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Lida', 'Initials': 'L', 'LastName': 'Jarahi', 'Affiliation': 'Department of Community Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Alinezhad-Namaghi', 'Affiliation': 'Department of Nutrition, Faculty of medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Seyed Mostafa', 'Initials': 'SM', 'LastName': 'Arabi', 'Affiliation': 'Department of Nutrition, Faculty of medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Saba', 'Initials': 'S', 'LastName': 'Vakili', 'Affiliation': 'Medical Genetics Research Centre, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Tohidinezhad', 'Affiliation': 'Department of Medical Informatics, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Yasaman', 'Initials': 'Y', 'LastName': 'Nikooiyan', 'Affiliation': 'Medical Student, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Abdolreza', 'Initials': 'A', 'LastName': 'Norouzy', 'Affiliation': 'Department of Nutrition, Faculty of medicine, Mashhad University of Medical Sciences, Mashhad, Iran. norouzya@mums.ac.ir.'}]",Advances in experimental medicine and biology,['10.1007/978-3-030-64872-5_1'] 3987,33861390,"Reduction of small dense LDL and Il-6 after intervention with Plantago psyllium in adolescents with obesity: a parallel, double blind, randomized clinical trial.","Obesity can lead children and adolescents to an increased cardiovascular disease (CVD) risk. A diet supplemented with Plantago psyllium has been shown to be effective in reducing LDL-C and IL-6 in adolescents. However, there are no studies that have explored small-dense LDL (sdLDL) or HDL subclasses. The aim of this study was to evaluate the impact of a fiber dietary intervention on LDL and HDL subclasses in adolescents with obesity. In this parallel, double blind, randomized clinical trial, the participants were assigned to Plantago psyllium or placebo (10g/day for 7 weeks). We randomized 113 participants, and evaluated and analyzed 100 adolescents (50 in each group), 15 to 19 years with a body mass index of 29-34. We measured biochemical markers LDL and HDL subclasses using the Lipoprint system (Quantimetrix) and IL-6 by ELISA. Post-treatment there was a decrease in sdLDL between the groups 2.0 (0-5.0) vs 1 (0-3.0) mg/dl (p = 0.004), IL-6 median 3.32 (1.24-5.96) vs 1.76 (0.54-3.28) pg/ml, p <0.0001. There were no differences in HDL subclasses and no adverse effects were reported in either group.Conclusions: Small dense LDL and IL-6 reduced in adolescents with obesity when consuming Plantago psyllium. This may be an early good strategy for the reduction of cardiovascular disease risk in this vulnerable population.Trial registration: ISRCTN # 14180431. Date assigned 24/08/2020 What is Known: • Supplementing the diet with Plantago psyllium lowers LDL-C levels. What is New: • First evidence that soluble fiber supplementation like Plantago psyllium decreases small dense LDL particles in association with lowered IL-6, reducing the risk of cardiovascular disease in obese adolescents.",2021,"Post-treatment there was a decrease in sdLDL between the groups 2.0 (0-5.0) vs 1 (0-3.0) mg/dl (p = 0.004), IL-6 median 3.32 (1.24-5.96) vs 1.76 (0.54-3.28) pg/ml, p <0.0001.","['adolescents with obesity', 'obese adolescents', '113 participants, and evaluated and analyzed 100 adolescents (50 in each group), 15 to 19 years with a body mass index of 29-34']","['fiber dietary intervention', 'Plantago psyllium', 'Plantago psyllium or placebo']","['LDL-C levels', 'cardiovascular disease (CVD) risk', 'HDL subclasses and no adverse effects', 'sdLDL', 'LDL and HDL subclasses', 'biochemical markers LDL and HDL subclasses using the Lipoprint system (Quantimetrix) and IL-6 by ELISA']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C1218742', 'cui_str': 'Plantago arenaria'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0445604', 'cui_str': 'Subclass'}, {'cui': 'C0853204', 'cui_str': 'No adverse effect'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}]",113.0,0.482384,"Post-treatment there was a decrease in sdLDL between the groups 2.0 (0-5.0) vs 1 (0-3.0) mg/dl (p = 0.004), IL-6 median 3.32 (1.24-5.96) vs 1.76 (0.54-3.28) pg/ml, p <0.0001.","[{'ForeName': 'Alma Patricia', 'Initials': 'AP', 'LastName': 'González', 'Affiliation': 'Department of Medical Science, Division of Health Science, University of Guanajuato, Campus León, Guanajuato, Mexico.'}, {'ForeName': 'Anaisa', 'Initials': 'A', 'LastName': 'Flores-Ramírez', 'Affiliation': 'Department of Medical Science, Division of Health Science, University of Guanajuato, Campus León, Guanajuato, Mexico.'}, {'ForeName': 'Karla Paola', 'Initials': 'KP', 'LastName': 'Gutiérrez-Castro', 'Affiliation': 'Department of Medical Science, Division of Health Science, University of Guanajuato, Campus León, Guanajuato, Mexico.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Luévano-Contreras', 'Affiliation': 'Department of Medical Science, Division of Health Science, University of Guanajuato, Campus León, Guanajuato, Mexico.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Gómez-Ojeda', 'Affiliation': 'Department of Medical Science, Division of Health Science, University of Guanajuato, Campus León, Guanajuato, Mexico.'}, {'ForeName': 'Gloria Patricia', 'Initials': 'GP', 'LastName': 'Sosa-Bustamante', 'Affiliation': 'High Specialty Medical Unit, Hospital of Gynecology and Pediatrics # 48, Mexican Institute of Social Security, León, Mexico.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Caccavello', 'Affiliation': 'Glycation, Oxidation and Disease Laboratory, Dept. of Research, College of Osteopathic Medicine, Touro University California, Vallejo, CA, USA.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Barrera-de León', 'Affiliation': 'Western National Medical Center, Mexican Institute of Social Security, Guadalajara, Mexico.'}, {'ForeName': 'Ma Eugenia', 'Initials': 'ME', 'LastName': 'Garay-Sevilla', 'Affiliation': 'Department of Medical Science, Division of Health Science, University of Guanajuato, Campus León, Guanajuato, Mexico. marugaray_2000@yahoo.com.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Gugliucci', 'Affiliation': 'Glycation, Oxidation and Disease Laboratory, Dept. of Research, College of Osteopathic Medicine, Touro University California, Vallejo, CA, USA. alejandro.gugliucci@tu.edu.'}]",European journal of pediatrics,['10.1007/s00431-021-04064-5'] 3988,33861375,Low-dose versus conventional-dose prednisolone for nephrotic syndrome relapses: a randomized controlled non-inferiority trial.,"BACKGROUND Reduction of steroid exposure in relapses of steroid-sensitive nephrotic syndrome (SSNS) is under-researched. METHODS In this randomized controlled non-inferiority trial, 1-12-year-old children with relapse of SSNS were randomized to receive prednisolone 1 mg/kg/day (low dose) or 2 mg/kg/day (standard dose) until disease remission or day 15, whichever was earlier. Therapy was switched to 2 mg/kg/day in children in low-dose group not in remission by day 15. Primary outcome was days to remission, and secondary outcome being pattern of subsequent relapse(s) over 1 year. Estimating time to remission of 8 ± 2.5 days with standard-dose therapy, non-inferiority margin of 2 days, 90% power, and α-0.05, 60 patients were randomized. RESULTS Of the 60 children (30 in each group) enrolled, 4 (one in low-dose group) failed remission by day 15. Time to remission was comparable between low-dose and standard-dose groups [9.0 ± 2.2 vs. 8.6 ± 2.2 days; mean difference (95% CI) 0.4 (- 0.79 to 1.59) days; p = 0.49], thus establishing non-inferiority of low dose. Median time to subsequent relapse was 86 (IQR 74.8, 97.2) and 150 (IQR 59.0, 240.9) days, in low- versus standard-dose groups, respectively (log rank p = 0.39). In follow-up, proportion of children having relapses, frequency of relapses, proportion with frequent relapse/steroid dependent (FR/SD), and cumulative corticosteroid dose taken were comparable between groups. CONCLUSIONS This study shows that time to achieve remission after treatment of a relapse with low-dose prednisolone is non-inferior to that after treatment with conventional dose in children with SSNS. The proportion of children achieving remission, further course, and pattern of relapses was comparable between both groups.",2021,"The proportion of children achieving remission, further course, and pattern of relapses was comparable between both groups.","['nephrotic syndrome relapses', 'children with SSNS', '60 children (30 in each group) enrolled, 4 (one in low-dose group) failed remission by day 15', '1-12-year-old children with relapse of SSNS']","['Low-dose versus conventional-dose prednisolone', 'prednisolone']","['Median time to subsequent relapse', 'proportion of children achieving remission, further course, and pattern of relapses', 'days to remission, and secondary outcome being pattern of subsequent relapse(s', 'Time to remission']","[{'cui': 'C0027726', 'cui_str': 'Nephrotic syndrome'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",60.0,0.246746,"The proportion of children achieving remission, further course, and pattern of relapses was comparable between both groups.","[{'ForeName': 'Seenam', 'Initials': 'S', 'LastName': 'Sheikh', 'Affiliation': 'Chacha Nehru Bal Chikitsalaya, Delhi, India.'}, {'ForeName': 'Kirtisudha', 'Initials': 'K', 'LastName': 'Mishra', 'Affiliation': 'Chacha Nehru Bal Chikitsalaya, Delhi, India. kirtisen@gmail.com.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Kumar', 'Affiliation': 'Chacha Nehru Bal Chikitsalaya, Delhi, India.'}]","Pediatric nephrology (Berlin, Germany)",['10.1007/s00467-021-05048-1'] 3989,33861329,Loving-Kindness Meditation vs Cognitive Processing Therapy for Posttraumatic Stress Disorder Among Veterans: A Randomized Clinical Trial.,"Importance Additional options are needed for treatment of posttraumatic stress disorder (PTSD) among veterans. Objective To determine whether group loving-kindness meditation is noninferior to group cognitive processing therapy for treatment of PTSD. Design, Setting, and Participants This randomized clinical noninferiority trial assessed PTSD and depression at baseline, posttreatment, and 3- and 6-month follow-up. Veterans were recruited from September 24, 2014, to February 5, 2018, from a large Veternas Affairs medical center in Seattle, Washington. A total of 184 veteran volunteers who met Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) criteria for PTSD were randomized. Data collection was completed November 28, 2018, and data analyses were conducted from December 10, 2018, to November 5, 2019. Interventions Each intervention comprised 12 weekly 90-minute group sessions. Loving-kindness meditation (n = 91) involves silent repetition of phrases intended to elicit feelings of kindness for oneself and others. Cognitive processing therapy (n = 93) combines cognitive restructuring with emotional processing of trauma-related content. Main Outcomes and Measures Co-primary outcomes were change in PTSD and depression scores over 6-month follow-up, assessed by the Clinician-Administered PTSD Scale (CAPS-5; range, 0-80; higher is worse) and Patient-Reported Outcome Measurement Information System (PROMIS; reported as standardized T-score with mean [SD] of 50 [10] points; higher is worse) depression measures. Noninferiority margins were 5 points on the CAPS-5 and 4 points on the PROMIS depression measure. Results Among the 184 veterans (mean [SD] age, 57.1 [13.1] years; 153 men [83.2%]; 107 White participants [58.2%]) included in the study, 91 (49.5%) were randomized to the loving-kindness group, and 93 (50.5%) were randomized to the cognitive processing group. The mean (SD) baseline CAPS-5 score was 35.5 (11.8) and mean (SD) PROMIS depression score was 60.9 (7.9). A total of 121 veterans (66%) completed 6-month follow-up. At 6 months posttreatment, mean CAPS-5 scores were 28.02 (95% CI, 24.72-31.32) for cognitive processing therapy and 25.92 (95% CI, 22.62-29.23) for loving-kindness meditation (difference, 2.09; 95% CI, -2.59 to 6.78), and mean PROMIS depression scores were 61.22 (95% CI, 59.21-63.23) for cognitive processing therapy and 58.88 (95% CI, 56.86-60.91) for loving-kindness meditation (difference, 2.34; 95% CI, -0.52 to 5.19). In superiority analyses, there were no significant between-group differences in CAPS-5 scores, whereas for PROMIS depression scores, greater reductions were found for loving-kindness meditation vs cognitive processing therapy (for patients attending ≥6 visits, ≥4-point improvement was noted in 24 [39.3%] veterans receiving loving-kindness meditation vs 9 (18.0%) receiving cognitive processing therapy; P = .03). Conclusions and Relevance Among veterans with PTSD, loving-kindness meditation resulted in reductions in PTSD symptoms that were noninferior to group cognitive processing therapy. For both interventions, the magnitude of improvement in PTSD symptoms was modest. Change over time in depressive symptoms was greater for loving-kindness meditation than for cognitive processing therapy. Trial Registration Clinicaltrials.gov Identifier: NCT01962714.",2021,"At 6 months posttreatment, mean CAPS-5 scores were 28.02 (95% CI, 24.72-31.32) for cognitive processing therapy and 25.92 (95% CI, 22.62-29.23) for loving-kindness meditation (difference, 2.09; 95% CI, -2.59 to 6.78), and mean PROMIS depression scores were 61.22 (95% CI, 59.21-63.23) for cognitive processing therapy and 58.88","['posttraumatic stress disorder (PTSD) among veterans', 'Veterans were recruited from September 24, 2014, to February 5, 2018, from a large Veternas Affairs medical center in Seattle, Washington', '184 veterans (mean [SD] age, 57.1 [13.1] years; 153 men [83.2%]; 107 White participants [58.2%]) included in the study, 91 (49.5%) were randomized to the loving-kindness group, and 93 (50.5', '184 veteran volunteers who met Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) criteria for PTSD were randomized', 'Data collection was completed November 28, 2018, and data analyses were conducted from December 10, 2018, to November 5, 2019', '121 veterans (66%) completed 6-month follow-up', 'Posttraumatic Stress Disorder Among Veterans', 'veterans with PTSD']","['Loving-Kindness Meditation vs Cognitive Processing Therapy', 'Loving-kindness meditation', 'Cognitive processing therapy (n\u2009=\u200993) combines cognitive restructuring with emotional processing of trauma-related content', 'cognitive processing group']","['mean (SD) PROMIS depression score', 'mean PROMIS depression scores', 'CAPS-5 score', 'PROMIS depression measure', 'depressive symptoms', 'mean (SD) baseline', 'mean CAPS-5 scores', 'change in PTSD and depression scores over 6-month follow-up, assessed by the Clinician-Administered PTSD Scale', 'CAPS-5 scores', 'PROMIS depression scores', 'PTSD symptoms']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0024028', 'cui_str': 'Love'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0024028', 'cui_str': 'Love'}, {'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0150173', 'cui_str': 'Cognitive restructuring'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021428', 'cui_str': 'Information system'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",184.0,0.311297,"At 6 months posttreatment, mean CAPS-5 scores were 28.02 (95% CI, 24.72-31.32) for cognitive processing therapy and 25.92 (95% CI, 22.62-29.23) for loving-kindness meditation (difference, 2.09; 95% CI, -2.59 to 6.78), and mean PROMIS depression scores were 61.22 (95% CI, 59.21-63.23) for cognitive processing therapy and 58.88","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Kearney', 'Affiliation': 'VA Puget Sound Health Care System, Seattle, Washington.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Malte', 'Affiliation': 'Center of Excellence in Substance Addiction Treatment and Education, VA Puget Sound Health Care System, Seattle, Washington.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Storms', 'Affiliation': 'VA Research and Development, VA Puget Sound Health Care System, Seattle, Washington.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Simpson', 'Affiliation': 'Center of Excellence in Substance Addiction Treatment and Education, VA Puget Sound Health Care System, Seattle, Washington.'}]",JAMA network open,['10.1001/jamanetworkopen.2021.6604'] 3990,33861314,A Deep Learning Convolutional Neural Network Can Differentiate Between Helicobacter Pylori Gastritis and Autoimmune Gastritis With Results Comparable to Gastrointestinal Pathologists.,"CONTEXT.— Pathology studies using convolutional neural networks (CNNs) have focused on neoplasms, while studies in inflammatory pathology are rare. We previously demonstrated a CNN differentiates reactive gastropathy, Helicobacter pylori gastritis (HPG), and normal gastric mucosa. OBJECTIVE.— To determine whether a CNN can differentiate the following 2 gastric inflammatory patterns: autoimmune gastritis (AG) and HPG. DESIGN.— Gold standard diagnoses were blindly established by 2 gastrointestinal (GI) pathologists. One hundred eighty-seven cases were scanned for analysis by HALO-AI. All levels and tissue fragments per slide were included for analysis. The cases were randomized, 112 (60%; 60 HPG, 52 AG) in the training set and 75 (40%; 40 HPG, 35 AG) in the test set. A HALO-AI correct area distribution (AD) cutoff of 50% or more was required to credit the CNN with the correct diagnosis. The test set was blindly reviewed by pathologists with different levels of GI pathology expertise as follows: 2 GI pathologists, 2 general surgical pathologists, and 2 residents. Each pathologist rendered their preferred diagnosis, HPG or AG. RESULTS.— At the HALO-AI AD percentage cutoff of 50% or more, the CNN results were 100% concordant with the gold standard diagnoses. On average, autoimmune gastritis cases had 84.7% HALO-AI autoimmune gastritis AD and HP cases had 87.3% HALO-AI HP AD. The GI pathologists, general anatomic pathologists, and residents were on average, 100%, 86%, and 57% concordant with the gold standard diagnoses, respectively. CONCLUSIONS.— A CNN can distinguish between cases of HPG and autoimmune gastritis with accuracy equal to GI pathologists.",2021,"On average, autoimmune gastritis cases had 84.7% HALO-AI autoimmune gastritis AD and HP cases had 87.3% HALO-AI HP AD.","['pathologists with different levels of GI pathology expertise as follows: 2 GI pathologists, 2 general surgical pathologists, and 2 residents', 'Helicobacter Pylori Gastritis and Autoimmune Gastritis', 'One hundred eighty-seven cases', '2 gastric inflammatory patterns: autoimmune gastritis (AG) and HPG']","['convolutional neural networks (CNNs', 'CNN']",[],"[{'cui': 'C0334866', 'cui_str': 'Medical pathologist'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0343378', 'cui_str': 'Helicobacter-associated gastritis'}, {'cui': 'C3887639', 'cui_str': 'Autoimmune gastritis'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]","[{'cui': 'C0242406', 'cui_str': 'Neural Networks (Anatomic)'}]",[],187.0,0.0766691,"On average, autoimmune gastritis cases had 84.7% HALO-AI autoimmune gastritis AD and HP cases had 87.3% HALO-AI HP AD.","[{'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Franklin', 'Affiliation': 'From the Department of Pathology, University of New Mexico School of Medicine, Albuquerque. Hanson and Martin are co-senior authors on the manuscript.'}, {'ForeName': 'Fred A', 'Initials': 'FA', 'LastName': 'Schultz', 'Affiliation': 'From the Department of Pathology, University of New Mexico School of Medicine, Albuquerque. Hanson and Martin are co-senior authors on the manuscript.'}, {'ForeName': 'Marissa A', 'Initials': 'MA', 'LastName': 'Tafoya', 'Affiliation': 'From the Department of Pathology, University of New Mexico School of Medicine, Albuquerque. Hanson and Martin are co-senior authors on the manuscript.'}, {'ForeName': 'Audra A', 'Initials': 'AA', 'LastName': 'Kerwin', 'Affiliation': 'From the Department of Pathology, University of New Mexico School of Medicine, Albuquerque. Hanson and Martin are co-senior authors on the manuscript.'}, {'ForeName': 'Cory J', 'Initials': 'CJ', 'LastName': 'Broehm', 'Affiliation': 'From the Department of Pathology, University of New Mexico School of Medicine, Albuquerque. Hanson and Martin are co-senior authors on the manuscript.'}, {'ForeName': 'Edgar G', 'Initials': 'EG', 'LastName': 'Fischer', 'Affiliation': 'From the Department of Pathology, University of New Mexico School of Medicine, Albuquerque. Hanson and Martin are co-senior authors on the manuscript.'}, {'ForeName': 'Rama R', 'Initials': 'RR', 'LastName': 'Gullapalli', 'Affiliation': 'From the Department of Pathology, University of New Mexico School of Medicine, Albuquerque. Hanson and Martin are co-senior authors on the manuscript.'}, {'ForeName': 'Douglas P', 'Initials': 'DP', 'LastName': 'Clark', 'Affiliation': 'From the Department of Pathology, University of New Mexico School of Medicine, Albuquerque. Hanson and Martin are co-senior authors on the manuscript.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Hanson', 'Affiliation': 'From the Department of Pathology, University of New Mexico School of Medicine, Albuquerque. Hanson and Martin are co-senior authors on the manuscript.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Martin', 'Affiliation': 'From the Department of Pathology, University of New Mexico School of Medicine, Albuquerque. Hanson and Martin are co-senior authors on the manuscript.'}]",Archives of pathology & laboratory medicine,['10.5858/arpa.2020-0520-OA'] 3991,33861306,Trajectories of Blood Pressure Control a Year after Randomization and Incident Cardiovascular Outcomes in SPRINT.,"BACKGROUND While studies have assessed the association between blood pressure trajectories and cardiovascular disease (CVD) outcomes using observational data, few have assessed these associations using clinical trial data. We sought to identify systolic blood pressure (SBP) trajectories and to determine if these trajectory patterns carry inherent CVD risk, irrespective of baseline blood pressure. METHODS SBP trajectories were identified using latent class group based modeling among a cohort of 8901Systolic Blood Pressure Intervention Trial (SPRINT) participants by incorporating SBP measures during the first 12 months of the trial post randomization. Cox models were used to evaluate the association between SBP trajectory with CVD and all-cause mortality. RESULTS Four distinct SBP trajectories were identified: 'low decline' (41%), 'high decline' (6%), 'low stable' (48%), and 'high stable' (5%). Relative to the 'low decline' group, the 'low stable' group was associated with a 29% increased risk of CVD (HR: 1.29, 95%CI: 1.06-1.57) and the 'high stable' group was associated with a 76% increased risk of all-cause mortality (HR: 1.76, 95%CI: 1.15-2.68). Relative to the 'low stable' group, the 'high stable' group was associated with a 54% increased risk of all-cause mortality (HR: 1.54, 95%CI: 1.05-2.28). CONCLUSIONS Our results demonstrate that SBP trajectory patterns are associated with important cardiovascular outcomes, irrespective of baseline blood pressure, which may help better identify individuals at risk and assist with accurate adjudication of antihypertensive therapy to reduce future events.",2021,"Relative to the 'low stable' group, the 'high stable' group was associated with a 54% increased risk of all-cause mortality (HR: 1.54, 95%CI: 1.05-2.28). ",[],[],"['systolic blood pressure (SBP) trajectories', 'risk of CVD', 'risk of all-cause mortality']",[],[],"[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.11214,"Relative to the 'low stable' group, the 'high stable' group was associated with a 54% increased risk of all-cause mortality (HR: 1.54, 95%CI: 1.05-2.28). ","[{'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'German', 'Affiliation': 'Section of Cardiology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Elfassy', 'Affiliation': 'Division of Epidemiology, Department of Public Health Sciences, University of Miami, Miami, FL.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Singleton', 'Affiliation': 'Section of Cardiology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Carlos J', 'Initials': 'CJ', 'LastName': 'Rodriguez', 'Affiliation': 'Division of Cardiology, Department of Medicine, Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Walter T', 'Initials': 'WT', 'LastName': 'Ambrosius', 'Affiliation': 'Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Yeboah', 'Affiliation': 'Section of Cardiology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC.'}]",American journal of hypertension,['10.1093/ajh/hpab059'] 3992,33861212,"A Gamified, Social Media-Inspired, Web-Based Personalized Normative Feedback Alcohol Intervention for Lesbian, Bisexual, and Queer-Identified Women: Protocol for a Hybrid Trial.","BACKGROUND Sexual minority women are more likely to drink alcohol, engage in heavy drinking, and experience alcohol-related problems than heterosexual women. However, culturally tailored interventions for this population have been slow to emerge. OBJECTIVE This type 1 effectiveness-implementation trial examines the feasibility and efficacy of a gamified, culturally tailored, personalized normative feedback (PNF) alcohol intervention for sexual minority women who psychologically identify as lesbian, bisexual, or queer (LBQ). METHODS The core components of a PNF intervention were delivered within LezParlay, a fun, social media-inspired, digital competition designed to challenge negative stereotypes about LBQ women and increase visibility. The competition was advertised on the web through social media platforms and collaboration with LBQ community organizations. After 2 rounds of play by a large cohort of LBQ women, a subsample of 500 drinkers already taking part in the competition were invited to participate in the evaluation study. Study participants were randomized to receive 1 of 3 unique sequences of PNF (ie, alcohol and stigma coping, alcohol and control, or control topics only) over 2 intervention rounds. Randomization was fully automated by the web app, and both researchers and participants were blinded. RESULTS Analyses will evaluate whether PNF on alcohol use reduces participants' drinking and negative consequences at 2 and 4 months postintervention; examine whether providing PNF on stigma-coping behaviors, in addition to alcohol use, further reduces alcohol use and consequences beyond PNF on alcohol alone; identify mediators and moderators of intervention efficacy; and examine broader LezParlay app engagement, acceptability, and perceived benefits. CONCLUSIONS This incognito intervention approach is uniquely oriented toward engaging and preventing alcohol-related risks among community populations of LBQ women who may view their heavy drinking as normative and not in need of change because of the visibility of alcohol use in sexual minority community spaces. Thus, this intervention strategy diverges from, and is intended to complement, more intensive programs being developed to meet the needs of LBQ women already motivated to reduce their consumption. TRIAL REGISTRATION ClinicalTrials.gov NCT03884478; https://clinicaltrials.gov/ct2/show/NCT03884478. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/24647.",2021,"This type 1 effectiveness-implementation trial examines the feasibility and efficacy of a gamified, culturally tailored, personalized normative feedback (PNF) alcohol intervention for sexual minority women who psychologically identify as lesbian, bisexual, or queer (LBQ). ","['Sexual minority women', 'LBQ women, a subsample of 500 drinkers already taking part in the competition were invited to participate in the evaluation study', 'sexual minority women who psychologically identify as lesbian, bisexual, or queer (LBQ']","['gamified, culturally tailored, personalized normative feedback (PNF) alcohol intervention', 'PNF (ie, alcohol and stigma coping, alcohol and control, or control topics only) over 2 intervention rounds', 'PNF']",['stigma-coping behaviors'],"[{'cui': 'C4277573', 'cui_str': 'Lesbigay Persons'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0242659', 'cui_str': 'Female homosexual'}, {'cui': 'C0005639', 'cui_str': 'Bisexuality'}, {'cui': 'C0019898', 'cui_str': 'Queers'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0015196', 'cui_str': 'Evaluation Studies'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}]","[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}]",,0.029247,"This type 1 effectiveness-implementation trial examines the feasibility and efficacy of a gamified, culturally tailored, personalized normative feedback (PNF) alcohol intervention for sexual minority women who psychologically identify as lesbian, bisexual, or queer (LBQ). ","[{'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Boyle', 'Affiliation': 'HeadsUp Labs, Department of Psychology, Loyola Marymount University, Los Angeles, CA, United States.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'LaBrie', 'Affiliation': 'HeadsUp Labs, Department of Psychology, Loyola Marymount University, Los Angeles, CA, United States.'}]",JMIR research protocols,['10.2196/24647'] 3993,33861211,Feasibility and Preliminary Efficacy of a Community-Based Addiction Rehabilitation Electronic System in Substance Use Disorder: Pilot Randomized Controlled Trial.,"BACKGROUND Drug use disorder has high potential for relapse and imposes an enormous burden on public health in China. Since the promulgation of the Anti-drug law in 2008, community-based rehabilitation has become the primary approach to treat drug addiction. However, multiple problems occurred in the implementation process, leading to a low detoxification rate in the community. Mobile health (mHealth) serves as a promising tool to improve the effectiveness and efficiency of community-based rehabilitation. Community-based addiction rehabilitation electronic system (CAREs) is an interactive system for drug users and their assigned social workers. OBJECTIVE The study aimed to examine the feasibility and preliminary efficacy of CAREs in community-based rehabilitation from the perspective of drug users and social workers in Shanghai, China. METHODS In this pilot randomized controlled trial, 40 participants were recruited from the community in Shanghai from January to May 2019. Participants randomized to the intervention group (n=20) received CAREs + community-based rehabilitation, while participants in the control group (n=20) received community-based rehabilitation only for 6 months. CAREs provided education, assessment, and SOS (support) functions for drug users. The assigned social workers provided service and monitored drug use behavior as usual except that the social workers in the intervention group could access the webpage end to obtain drug users' information and fit their routine workflow into CAREs. The primary outcome was the feasibility of CAREs, reflected in the overall proportion and frequency of CAREs features used in both app and webpage end. The secondary outcomes were the effectiveness of CAREs, including the percentage of drug-positive samples, longest period of abstinence, contact times with social workers, and the change of Addiction Severity Index (ASI) from baseline to the 6-month follow-up. RESULTS The number of participants logged in to the app ranged from 7 to 20 per week, and CAREs had relatively high levels of continued patient use. Drug users preferred assessment and education features in the app end while their social workers showed high levels of use in urine results record and viewing assessment results on the webpage end. After the 6-month intervention, 3.3% (17/520) of samples in the intervention group and 7.5% (39/520) in the control group were drug-positive (F=4.358, P=.04). No significant differences were noted between the control and intervention groups in terms of longest duration of abstinence, number of contact times and ASI composite scores. CONCLUSIONS The study preliminarily demonstrated that with relatively good feasibility and acceptability, CAREs may improve the effectiveness and efficiency of the community-based rehabilitation, which provided instruction for further improvement of the system. TRIAL REGISTRATION ClinicalTrials.gov NCT03451344; https://clinicaltrials.gov/ct2/show/NCT03451344. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) RR2-10.3389/fpsyt.2018.00556.",2021,"No significant differences were noted between the control and intervention groups in terms of longest duration of abstinence, number of contact times and ASI composite scores. ","['drug users and their assigned social workers', 'community-based rehabilitation from the perspective of drug users and social workers in Shanghai, China.\nMETHODS', 'Substance Use Disorder', '40 participants were recruited from the community in Shanghai from January to May 2019']","['Community-Based Addiction Rehabilitation Electronic System', 'CAREs + community-based rehabilitation, while participants in the control group (n=20) received community-based rehabilitation only for 6 months', 'CAREs', 'Community-based addiction rehabilitation electronic system (CAREs']","['CAREs provided education, assessment, and SOS (support) functions', 'effectiveness of CAREs, including the percentage of drug-positive samples, longest period of abstinence, contact times with social workers, and the change of Addiction Severity Index (ASI', 'low detoxification rate', 'longest duration of abstinence, number of contact times and ASI composite scores', 'overall proportion and frequency of CAREs features used in both app and webpage end', 'drug-positive', 'feasibility of CAREs']","[{'cui': 'C0338666', 'cui_str': 'Misuses drugs'}, {'cui': 'C0037444', 'cui_str': 'Social worker'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037703', 'cui_str': 'SOS Response (Genetics)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037444', 'cui_str': 'Social worker'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0450981', 'cui_str': 'Addiction severity index'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0025516', 'cui_str': 'Detoxication, Drug, Metabolic'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0444930', 'cui_str': 'End'}]",40.0,0.0740768,"No significant differences were noted between the control and intervention groups in terms of longest duration of abstinence, number of contact times and ASI composite scores. ","[{'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Shujuan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Junning', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Nantong Winner Information Technology Co Ltd, Nantong, China.'}, {'ForeName': 'Zhikang', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Fu', 'Affiliation': 'Council of Shanghai Ziqiang Social Services, Shanghai, China.'}, {'ForeName': 'Dingchen', 'Initials': 'D', 'LastName': 'Song', 'Affiliation': 'Council of Shanghai Zhongzhi Social Services, Shanghai, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}]",JMIR mHealth and uHealth,['10.2196/21087'] 3994,33861204,Mobile Health Intervention Promoting Physical Activity in Adults Post Cardiac Rehabilitation: Pilot Randomized Controlled Trial.,"BACKGROUND Cardiac rehabilitation (CR) is an exercise-based program prescribed after cardiac events associated with improved physical, mental, and social functioning; however, many patients return to a sedentary lifestyle leading to deteriorating functional capacity after discharge from CR. Physical activity (PA) is critical to avoid recurrence of cardiac events and mortality and maintain functional capacity. Leveraging mobile health (mHealth) strategies to increase adherence to PA is a promising approach. Based on the social cognitive theory, we sought to determine whether mHealth strategies (Movn mobile app for self-monitoring, supportive push-through messages, and wearable activity tracker) would improve PA and functional capacity over 2 months. OBJECTIVE The objectives of this pilot randomized controlled trial were to examine preliminary effects of an mHealth intervention on group differences in PA and functional capacity and group differences in depression and self-efficacy to maintain exercise after CR. METHODS During the final week of outpatient CR, patients were randomized 1:1 to the intervention group or usual care. The intervention group downloaded the Movn mobile app, received supportive push-through messages on motivation and educational messages related to cardiovascular disease (CVD) management 3 times per week, and wore a Charge 2 (Fitbit Inc) activity tracker to track step counts. Participants in the usual care group wore a pedometer and recorded their daily steps in a diary. Data from the 6-minute walk test (6MWT) and self-reported questionnaires were collected at baseline and 2 months. RESULTS We recruited 60 patients from 2 CR sites at a community hospital in Northern California. The mean age was 68.0 (SD 9.3) years, and 23% (14/60) were female; retention rate was 85% (51/60). Our results from 51 patients who completed follow-up showed the intervention group had a statistically significant higher mean daily step count compared with the control (8860 vs 6633; P=.02). There was no difference between groups for the 6MWT, depression, or self-efficacy to maintain exercise. CONCLUSIONS This intervention addresses a major public health initiative to examine the potential for mobile health strategies to promote PA in patients with CVD. Our technology-based pilot mHealth intervention provides promising results on a pragmatic and contemporary approach to promote PA by increasing daily step counts after completing CR. TRIAL REGISTRATION ClinicalTrials.gov NCT03446313; https://clinicaltrials.gov/ct2/show/NCT03446313.",2021,Our results from 51 patients who completed follow-up showed the intervention group had a statistically significant higher mean daily step count compared with the control (8860 vs 6633; P=.02).,"['Adults Post', '60 patients from 2 CR sites at a community hospital in Northern California', 'patients with CVD', 'The mean age was 68.0 (SD 9.3) years, and 23% (14/60) were female; retention rate was 85% (51/60']","['mHealth intervention', 'Mobile Health Intervention', 'mHealth strategies (Movn mobile app for self-monitoring, supportive push-through messages, and wearable activity tracker', 'intervention group or usual care', 'Cardiac rehabilitation (CR', 'Movn mobile app, received supportive push-through messages on motivation and educational messages related to cardiovascular disease (CVD) management 3 times per week, and wore a Charge 2 (Fitbit Inc) activity tracker to track step counts']","['6MWT, depression, or self-efficacy to maintain exercise', 'depression and self-efficacy', 'Physical activity (PA', '6-minute walk test (6MWT) and self-reported questionnaires', 'PA and functional capacity', 'mean daily step count']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}]","[{'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",60.0,0.0289833,Our results from 51 patients who completed follow-up showed the intervention group had a statistically significant higher mean daily step count compared with the control (8860 vs 6633; P=.02).,"[{'ForeName': 'Linda G', 'Initials': 'LG', 'LastName': 'Park', 'Affiliation': 'Department of Community Health Systems, School of Nursing, University of California San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Abdelaziz', 'Initials': 'A', 'LastName': 'Elnaggar', 'Affiliation': 'Department of Community Health Systems, School of Nursing, University of California San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Sei J', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Division of Geriatrics, School of Medicine, University of California San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Merek', 'Affiliation': 'San Francisco Department of Veterans Affairs Health Care System, San Francisco, CA, United States.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Hoffmann', 'Affiliation': 'Institute for Human Genetics, University of California San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Von Oppenfeld', 'Affiliation': 'San Francisco Department of Veterans Affairs Health Care System, San Francisco, CA, United States.'}, {'ForeName': 'Nerissa', 'Initials': 'N', 'LastName': 'Ignacio', 'Affiliation': 'San Francisco Department of Veterans Affairs Health Care System, San Francisco, CA, United States.'}, {'ForeName': 'Mary A', 'Initials': 'MA', 'LastName': 'Whooley', 'Affiliation': 'Departments of Medicine and Epidemiology & Biostatistics, University of California San Francisco, San Francisco, CA, United States.'}]",JMIR formative research,['10.2196/20468'] 3995,33861194,Adrenaline to improve survival in out-of-hospital cardiac arrest: the PARAMEDIC2 RCT.,"BACKGROUND Adrenaline has been used as a treatment for cardiac arrest for many years, despite uncertainty about its effects on long-term outcomes and concerns that it may cause worse neurological outcomes. OBJECTIVES The objectives were to evaluate the effects of adrenaline on survival and neurological outcomes, and to assess the cost-effectiveness of adrenaline use. DESIGN This was a pragmatic, randomised, allocation-concealed, placebo-controlled, parallel-group superiority trial and economic evaluation. Costs are expressed in Great British pounds and reported in 2016/17 prices. SETTING This trial was set in five NHS ambulance services in England and Wales. PARTICIPANTS Adults treated for an out-of-hospital cardiac arrest were included. Patients were ineligible if they were pregnant, if they were aged < 16 years, if the cardiac arrest had been caused by anaphylaxis or life-threatening asthma, or if adrenaline had already been given. INTERVENTIONS Participants were randomised to either adrenaline (1 mg) or placebo in a 1 : 1 allocation ratio by the opening of allocation-concealed treatment packs. MAIN OUTCOME MEASURES The primary outcome was survival to 30 days. The secondary outcomes were survival to hospital admission, survival to hospital discharge, survival at 3, 6 and 12 months, neurological outcomes and health-related quality of life through to 6 months. The economic evaluation assessed the incremental cost per quality-adjusted life-year gained from the perspective of the NHS and Personal Social Services. Participants, clinical teams and those assessing patient outcomes were masked to the treatment allocation. RESULTS From December 2014 to October 2017, 8014 participants were assigned to the adrenaline ( n  = 4015) or to the placebo ( n  = 3999) arm. At 30 days, 130 out of 4012 participants (3.2%) in the adrenaline arm and 94 out of 3995 (2.4%) in the placebo arm were alive (adjusted odds ratio for survival 1.47, 95% confidence interval 1.09 to 1.97). For secondary outcomes, survival to hospital admission was higher for those receiving adrenaline than for those receiving placebo (23.6% vs. 8.0%; adjusted odds ratio 3.83, 95% confidence interval 3.30 to 4.43). The rate of favourable neurological outcome at hospital discharge was not significantly different between the arms (2.2% vs. 1.9%; adjusted odds ratio 1.19, 95% confidence interval 0.85 to 1.68). The pattern of improved survival but no significant improvement in neurological outcomes continued through to 6 months. By 12 months, survival in the adrenaline arm was 2.7%, compared with 2.0% in the placebo arm (adjusted odds ratio 1.38, 95% confidence interval 1.00 to 1.92). An adjusted subgroup analysis did not identify significant interactions. The incremental cost-effectiveness ratio for adrenaline was estimated at £1,693,003 per quality-adjusted life-year gained over the first 6 months after the cardiac arrest event and £81,070 per quality-adjusted life-year gained over the lifetime of survivors. Additional economic analyses estimated incremental cost-effectiveness ratios for adrenaline at £982,880 per percentage point increase in overall survival and £377,232 per percentage point increase in neurological outcomes over the first 6 months after the cardiac arrest. LIMITATIONS The estimate for survival with a favourable neurological outcome is imprecise because of the small numbers of patients surviving with a good outcome. CONCLUSIONS Adrenaline improved long-term survival, but there was no evidence that it significantly improved neurological outcomes. The incremental cost-effectiveness ratio per quality-adjusted life-year exceeds the threshold of £20,000-30,000 per quality-adjusted life-year usually supported by the NHS. FUTURE WORK Further research is required to better understand patients' preferences in relation to survival and neurological outcomes after out-of-hospital cardiac arrest and to aid interpretation of the trial findings from a patient and public perspective. TRIAL REGISTRATION Current Controlled Trials ISRCTN73485024 and EudraCT 2014-000792-11. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 25, No. 25. See the NIHR Journals Library website for further project information.",2021,"Additional economic analyses estimated incremental cost-effectiveness ratios for adrenaline at £982,880 per percentage point increase in overall survival and £377,232 per percentage point increase in neurological outcomes over the first 6 months after the cardiac arrest. ","['five NHS ambulance services in England and Wales', 'Patients were ineligible if they were pregnant, if they were aged <\u200916 years, if the cardiac arrest had been caused by anaphylaxis or life-threatening asthma, or if adrenaline had already been given', 'Adults treated for an out-of-hospital cardiac arrest were included', 'From December 2014 to October 2017, 8014 participants were assigned to the']","['placebo in a 1\u2009:\u20091 allocation ratio by the opening of allocation-concealed treatment packs', 'adrenaline', 'placebo', 'Adrenaline']","['neurological outcomes', 'long-term survival', 'survival to hospital admission, survival to hospital discharge, survival at 3, 6 and 12 months, neurological outcomes and health-related quality of life through to 6 months', 'survival', 'incremental cost-effectiveness ratios', 'incremental cost-effectiveness ratio per quality-adjusted life-year', 'survival to hospital admission', 'incremental cost-effectiveness ratio for adrenaline', 'survival to 30 days', 'rate of favourable neurological outcome at hospital discharge', 'survival and neurological outcomes', 'overall survival']","[{'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0002422', 'cui_str': 'Ambulance'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0002792', 'cui_str': 'Anaphylaxis'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0443189', 'cui_str': 'Concealed'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",8014.0,0.597479,"Additional economic analyses estimated incremental cost-effectiveness ratios for adrenaline at £982,880 per percentage point increase in overall survival and £377,232 per percentage point increase in neurological outcomes over the first 6 months after the cardiac arrest. ","[{'ForeName': 'Gavin D', 'Initials': 'GD', 'LastName': 'Perkins', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Ji', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Achana', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'John Jm', 'Initials': 'JJ', 'LastName': 'Black', 'Affiliation': 'South Central Ambulance Service NHS Foundation Trust, Bicester, UK.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Charlton', 'Affiliation': 'North East Ambulance Service NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Crawford', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'de Paeztron', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Deakin', 'Affiliation': 'Southampton University Hospital, Southampton, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Docherty', 'Affiliation': 'West Midlands Ambulance Service University NHS Foundation Trust, Brierley Hill, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Finn', 'Affiliation': 'Prehospital, Resuscitation and Emergency Care Research Unit (PRECRU), Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Rachael T', 'Initials': 'RT', 'LastName': 'Fothergill', 'Affiliation': 'London Ambulance Service NHS Trust, London, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gates', 'Affiliation': 'Cancer Research Clinical Trials Unit (CRCTU), University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Imogen', 'Initials': 'I', 'LastName': 'Gunson', 'Affiliation': 'West Midlands Ambulance Service University NHS Foundation Trust, Brierley Hill, UK.'}, {'ForeName': 'Kyee', 'Initials': 'K', 'LastName': 'Han', 'Affiliation': 'North East Ambulance Service NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Susie', 'Initials': 'S', 'LastName': 'Hennings', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Horton', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Khan', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lamb', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Long', 'Affiliation': 'Patient and Public Involvement Representative, Warwick, UK.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': 'West Midlands Ambulance Service University NHS Foundation Trust, Brierley Hill, UK.'}, {'ForeName': 'Fionna', 'Initials': 'F', 'LastName': 'Moore', 'Affiliation': 'South East Coast Ambulance Service NHS Foundation Trust, Crawley, UK.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Nolan', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Lyndsey', 'Initials': 'L', 'LastName': ""O'Shea"", 'Affiliation': 'Welsh Ambulance Service NHS Trust, St Asaph, UK.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Petrou', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Pocock', 'Affiliation': 'South Central Ambulance Service NHS Foundation Trust, Bicester, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Quinn', 'Affiliation': ""Emergency, Cardiovascular and Critical Care Research Group, Faculty of Health, Social Care and Education, Kingston University London and St George's, University of London, London, UK.""}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Rees', 'Affiliation': 'Welsh Ambulance Service NHS Trust, St Asaph, UK.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Regan', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Rosser', 'Affiliation': 'West Midlands Ambulance Service University NHS Foundation Trust, Brierley Hill, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Scomparin', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Slowther', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Ranjit', 'Initials': 'R', 'LastName': 'Lall', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta25250'] 3996,33860985,Change in cervical length after arrested preterm labor and the risk of preterm birth.,"OBJECTIVES To assess the association between preterm birth and cervical length after arrested preterm labour in high-risk women. METHODS In this post-hoc analysis of a randomised clinical trial, transvaginal cervical length was measured in women in whom contractions had ceased 48h after admission for threatened preterm labour. At admission, women were defined as high risk of preterm birth based on cervical length <15 mm or cervical length 15-30 mm with a positive foetal fibronectin test. Using logistic regression analysis, the association of cervical length after 48h (C2) and change in cervical length between admission (C1) and 48h later (Δc = C2-C1) was investigated with preterm birth before 34 weeks and delivery within 7 days of admission. RESULTS A total of 164 women were included in the analysis. Women whose cervical length (Δc) increased between admission for threatened preterm labour and 48 hours later (N=32%) were found to have a lower risk of preterm birth <34 weeks, compared to women whose cervical length did not change (odds ratio (OR) 0.24, 95% CI 0.09 to 0.69). The risk of women with a decrease in cervical length was not different (OR 1.45 95% CI 0.62 to 3.41) compared to no change in cervical length. Moreover, a longer absolute cervical length (C2) after 48 hours resulted in a lower risk of preterm birth <34 weeks and a lower risk of delivery <7 days (OR 0.90, 95% CI 0.84 to 0.96 and OR 0.91, 95% CI 0.82 to 1.02, respectively). Sensitivity analysis in women randomised to no intervention showed comparable results. CONCLUSIONS Our study suggests that the risk of preterm birth before 34 weeks is lower when cervical length increased between admission for threatened preterm labour and 48 hours later when contractions have ceased, compared to when cervical length did not change or decreased. This article is protected by copyright. All rights reserved.",2021,The risk of women with a decrease in cervical length was not different (OR 1.45 95% CI 0.62 to 3.41) compared to no change in cervical length.,"['high-risk women', 'A total of 164 women were included in the analysis', 'women in whom contractions had ceased 48h after admission for threatened preterm labour']",[],"['preterm birth and cervical length', 'cervical length', 'transvaginal cervical length', 'absolute cervical length (C2']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0022876', 'cui_str': 'Premature labor'}]",[],"[{'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}]",164.0,0.505789,The risk of women with a decrease in cervical length was not different (OR 1.45 95% CI 0.62 to 3.41) compared to no change in cervical length.,"[{'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Rennert', 'Affiliation': 'Faculty of Medicine, Vrije Universiteit Amsterdam, Amsterdam.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Breuking', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amsterdam Reproduction & Development research institute, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Schuit', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'M N', 'Initials': 'MN', 'LastName': 'Bekker', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Woiski', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'de Boer', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amsterdam Reproduction & Development research institute, Amsterdam UMC, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sueters', 'Affiliation': 'Department of Obstetrics and Gynaecology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'H C J', 'Initials': 'HCJ', 'LastName': 'Scheepers', 'Affiliation': 'Department of Obstetrics and Gynaecology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'M T M', 'Initials': 'MTM', 'LastName': 'Franssen', 'Affiliation': 'Department of Obstetrics, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Pajkrt', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amsterdam Reproduction & Development research institute, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'B W J', 'Initials': 'BWJ', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, School of Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kok', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amsterdam Reproduction & Development research institute, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'F J R', 'Initials': 'FJR', 'LastName': 'Hermans', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amsterdam Reproduction & Development research institute, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}]",Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology,['10.1002/uog.23653'] 3997,33860972,Effectiveness of a video-based advance care planning intervention in hospitalized elderly patients: A randomized controlled trial.,"AIM This study aimed to develop a video-based advance care planning intervention, and examine the effectiveness of the intervention on knowledge, behavioral intentions and advance directive signing among older patients admitted to a geriatric unit in Taiwan. METHODS This randomized controlled trial was carried out in two geriatric wards of a medical center in northern Taiwan, between June 2014 and June 2015. The participants were randomly assigned to the intervention (n = 39) or control (n = 43) group. Participants in the intervention group watched a 5-min video regarding advance care planning. The control group received usual care. Structured questionnaires on advance care planning knowledge and behavioral intentions were administered to both groups before and after the intervention. Advance directive signing was carried out until 2 weeks after hospital discharge through a chart review. RESULTS The intervention group showed a significantly higher advance care planning knowledge score and behavioral intention score than the control group post-intervention. The rate of advance directive signing was 33.3% in the intervention group and 9.3% in the control group (P = 0.01). CONCLUSIONS This study showed the effectiveness of video-based interventions in increasing advance care planning knowledge, behavioral intention and advance directive signing among hospitalized older patients. Geriatric wards could use our model to promote advance care planning among older patients. Geriatr Gerontol Int 2021; ••: ••-••.",2021,The intervention group showed a significantly higher advance care planning knowledge score and behavioral intention score than the control group post-intervention.,"['hospitalized elderly patients', 'older patients admitted to a geriatric unit in Taiwan', 'two geriatric wards of a medical center in northern Taiwan, between June 2014 and June 2015', 'hospitalized older patients', 'older patients']","['usual care', 'video-based advance care planning intervention', 'video-based interventions', '5-min video regarding advance care planning']","['knowledge, behavioral intentions and advance directive signing', 'advance care planning knowledge score and behavioral intention score', 'rate of advance directive signing']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0215501,The intervention group showed a significantly higher advance care planning knowledge score and behavioral intention score than the control group post-intervention.,"[{'ForeName': 'Li-Hwa', 'Initials': 'LH', 'LastName': 'Lin', 'Affiliation': 'Department of Nursing, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Hui-Chuan', 'Initials': 'HC', 'LastName': 'Cheng', 'Affiliation': 'Department of Nursing, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Yu-Chih', 'Initials': 'YC', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Research, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Li-Yin', 'Initials': 'LY', 'LastName': 'Chien', 'Affiliation': 'Institute of Community Health Care, College of Nursing, National Yang Ming Chiao Tung University, Taipei, Taiwan.'}]",Geriatrics & gerontology international,['10.1111/ggi.14158'] 3998,33860924,Budget Impact Analysis of Vericiguat for the Treatment of Chronic Heart Failure with Reduced Ejection Fraction Following a Worsening Event.,"INTRODUCTION In the USA, patients with chronic heart failure (HF) with reduced ejection fraction (HFrEF) following a worsening HF event (WHFE) have significantly increased healthcare resource use and medical costs. This analysis aimed to estimate the budget impact of vericiguat as an add-on therapy to guideline-directed medical therapy (GDMT) for the treatment of chronic HFrEF following a WHFE from a US commercial payer perspective. METHODS A model was developed to estimate the budget impact of adding vericiguat to the formulary by comparing a current scenario (GDMT) and a new scenario (vericiguat plus GDMT) to a hypothetical 10-million-member commercial payer over a 3-year time horizon. Epidemiology data was obtained from literature. Treatment utilization rates of GDMT and clinical inputs (HF hospitalization and cardiovascular [CV] morality) were based on the VICTORIA trial in which patients with chronic HFrEF following a WHFE were randomized to GDMT plus placebo or GDMT plus vericiguat. Costs (2020 US$) included drug acquisition, hospitalization, routine care, and mortality. RESULTS Approximately 20,510 prevalent cases in year 1 and 3109 annual incident cases in subsequent years were estimated to be eligible for treatment with vericiguat. At a utilization rate of 5%, 10%, and 15% for vericiguat over years 1-3, the per member per month (PMPM) budget impact was estimated to be $0.048, $0.064, and $0.086, respectively, associated with 44, 32, and 30 fewer HF hospitalizations and 7, 12, and 18 fewer CV deaths, respectively. Reduction in HF hospitalizations and CV deaths reduced the budget impact by 14% in total over 3 years. CONCLUSION Adding vericiguat to commercial plan formulary was associated with limited budget impact, primarily driven by drug acquisition costs but partially offset by reduced cost of HF hospitalizations and CV deaths.",2021,"Adding vericiguat to commercial plan formulary was associated with limited budget impact, primarily driven by drug acquisition costs but partially offset by reduced cost of HF hospitalizations and CV deaths.","['patients with chronic heart failure (HF) with reduced ejection fraction (HFrEF) following a worsening HF event (WHFE', 'patients with chronic HFrEF following a WHFE']",['GDMT plus placebo'],"['cost of HF hospitalizations and CV deaths', 'drug acquisition, hospitalization, routine care, and mortality', 'HF hospitalizations and CV deaths', 'utilization rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.0996116,"Adding vericiguat to commercial plan formulary was associated with limited budget impact, primarily driven by drug acquisition costs but partially offset by reduced cost of HF hospitalizations and CV deaths.","[{'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Alsumali', 'Affiliation': 'Center for Observational and Real-World Evidence, Merck & Co, Inc, Kenilworth, NJ, USA. adnan.alsumali@merck.com.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Lautsch', 'Affiliation': 'Center for Observational and Real-World Evidence, Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Rongzhe', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Pharmerit - an OPEN Health Company, Bethesda, MD, USA.'}, {'ForeName': 'Dipen', 'Initials': 'D', 'LastName': 'Patel', 'Affiliation': 'Pharmerit - an OPEN Health Company, Bethesda, MD, USA.'}, {'ForeName': 'Sakina', 'Initials': 'S', 'LastName': 'Nanji', 'Affiliation': 'Pharmerit - an OPEN Health Company, Bethesda, MD, USA.'}, {'ForeName': 'Laurence M', 'Initials': 'LM', 'LastName': 'Djatche', 'Affiliation': 'Center for Observational and Real-World Evidence, Merck & Co, Inc, Kenilworth, NJ, USA.'}]",Advances in therapy,['10.1007/s12325-021-01681-2'] 3999,33860888,Comparison of visual and refractive outcomes of diffractive bifocal toric and trifocal toric intraocular lenses 12 months after implantation in patients with moderate to high myopia.,"PURPOSE To compare the visual and refractive outcomes of bifocal toric and trifocal toric intraocular lenses (IOL) in patients with moderate to high myopia at 12 months after implantation. METHOD This is a prospective and comparative study. In 120 eyes with moderate to high myopia and astigmatism, bifocal toric IOLs (n = 60 eyes) or trifocal toric IOLs (n = 60 eyes) were implanted. Eyes with axial lengths from 24.0 to 26.5 mm were included. Postoperative examinations measured near, intermediate, and distance visual acuity (VA), along with refractive measurements, binocular defocus curves, and patient satisfaction with the National Eye Institute Visual Function Questionnaire. RESULTS For uncorrected- and corrected distance intermediate VA, the trifocal group showed significantly better VA at 1, 3, 6, and 12 months than the bifocal group. Driving subscale scores from the questionnaire were significantly better in the trifocal than the bifocal group. Concerning the binocular defocus curve, uncorrected distance VA was significantly higher in the trifocal than bifocal group at test distances of -1.5 D. CONCLUSIONS Both trifocal and bifocal toric IOLs effectively corrected the near, intermediate, and distance vision in patients with moderate to high myopia and astigmatism. However, intermediate vision was significantly better in eyes with trifocal than bifocal toric IOLs.",2021,"Concerning the binocular defocus curve, uncorrected distance VA was significantly higher in the trifocal than bifocal group at test distances of -1.5 D. ","['Eyes with axial lengths from 24.0 to 26.5\xa0mm were included', 'patients with moderate to high myopia', 'patients with moderate to high myopia and astigmatism', '120 eyes with moderate to high myopia and astigmatism, bifocal toric IOLs (n\u2009=\u200960 eyes) or trifocal toric IOLs (n\u2009=\u200960 eyes) were implanted', 'patients with moderate to high myopia at 12\xa0months after implantation']","['bifocal toric and trifocal toric intraocular lenses (IOL', 'diffractive bifocal toric and trifocal toric intraocular lenses']","['intermediate vision', 'uncorrected distance VA', 'Driving subscale scores', 'Postoperative examinations measured near, intermediate, and distance visual acuity (VA), along with refractive measurements, binocular defocus curves, and patient satisfaction with the National Eye Institute Visual Function Questionnaire']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0271183', 'cui_str': 'Severe myopia'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C1275647', 'cui_str': 'Bifocal glasses'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C1275646', 'cui_str': 'Trifocal glasses'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C1275647', 'cui_str': 'Bifocal glasses'}, {'cui': 'C1275646', 'cui_str': 'Trifocal glasses'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}]","[{'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C1955969', 'cui_str': 'National Eye Institute'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",120.0,0.0347343,"Concerning the binocular defocus curve, uncorrected distance VA was significantly higher in the trifocal than bifocal group at test distances of -1.5 D. ","[{'ForeName': 'Abdulhakim', 'Initials': 'A', 'LastName': 'Tekce', 'Affiliation': 'Department of Ophthalmology, The Lazer Eye Hospital, Kayseri, Turkey. drabdulhakimtekce38@gmail.com.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Gulmez', 'Affiliation': 'Department of Ophthalmology, The Dunya Eye Hospital, Konya, Turkey.'}]",International ophthalmology,['10.1007/s10792-021-01865-3'] 4000,33860839,"Age-related hearing loss, depression and auditory amplification: a randomized clinical trial.","PURPOSE Our study investigates the effectiveness of aural rehabilitation to decrease depressive symptoms in older adults, and the relationship between hearing loss and depression. METHODS A randomized controlled study was conducted at a hearing rehabilitation center with people over 65 years old. Participants were randomly allocated to the intervention group who received hearing aids, or to the control group. Data collection included pure-tone audiometry and a Portuguese version of the Geriatric Depression Scale assessed at two time points: baseline (P0) and after 4-week period (P1). RESULTS The results show that the increase of hearing thresholds in pure-tone audiometry is associated with a significant increase in depressive symptoms (p = 0.001). The effect of aural rehabilitation for improving depressive symptoms was significant in intervention group (p = 0.000) and between groups (p = 0.003) in P1. CONCLUSION Age-related hearing loss has adverse effects on older adults' mental health, due to reduced hearing inputs that may increase levels of effort to communicate and affect social engagement, which lead to depression. Hearing aid use improves levels of depression and can promote greater quality of life in older adults.",2021,"The effect of aural rehabilitation for improving depressive symptoms was significant in intervention group (p = 0.000) and between groups (p = 0.003) in P1. ","['hearing rehabilitation center with people over 65\xa0years old', 'older adults']","['aural rehabilitation', 'hearing aids, or to the control group']","['hearing thresholds', 'quality of life', 'depressive symptoms', 'pure-tone audiometry and a Portuguese version of the Geriatric Depression Scale']","[{'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0034994', 'cui_str': 'Hearing Impaired Rehabilitation'}, {'cui': 'C0018768', 'cui_str': 'Hearing aid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0234732', 'cui_str': 'Threshold of hearing'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0004292', 'cui_str': 'Pure tone audiometry'}, {'cui': 'C0032730', 'cui_str': 'Portuguese'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}]",,0.016826,"The effect of aural rehabilitation for improving depressive symptoms was significant in intervention group (p = 0.000) and between groups (p = 0.003) in P1. ","[{'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Marques', 'Affiliation': 'Department of Biomedicine, Faculty of Medicine, University of Porto, Porto, Portugal. tatiana.marques@estescoimbra.pt.'}, {'ForeName': 'Filipa D', 'Initials': 'FD', 'LastName': 'Marques', 'Affiliation': 'Department of Education, Coimbra College of Education, Coimbra, Portugal.'}, {'ForeName': 'António', 'Initials': 'A', 'LastName': 'Miguéis', 'Affiliation': 'University Clinic of Otorhinolaryngology, Faculty of Medicine, University of Coimbra, Coimbra, Portugal.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-021-06805-6'] 4001,33860790,Neurophysiological Contributors to Advantageous Risk-Taking: An Experimental Psychopharmacological Investigation.,"The ability to learn from experience is critical for determining when to take risks and when to play it safe. However, we know little about how within-person state changes, such as an individual's degree of neurophysiological arousal, may impact the ability to learn which risks are most likely to fail vs. succeed. To test this, we used a randomized, double-blind, placebo-controlled design to pharmacologically manipulate neurophysiological arousal and assess its causal impact on risk-related learning and performance. Eighty-seven adults (45% female, Mage= 20.1 ± 1.46 years) took either propranolol (n= 42), a beta-adrenergic receptor blocker that attenuates sympathetic nervous system-related signaling, or a placebo (n= 45). Participants then completed the Balloon Emotional Learning Task, a risk-taking task wherein experiential learning is necessary for task success. We found that individuals on propranolol, relative to placebo, earned fewer points on the task, suggesting that they were less effective risk-takers. This effect was mediated by the fact that those on propranolol made less optimal decisions in the final phase of the task on trials with the greatest opportunity for advantageous risk-taking. These findings highlight how neurophysiological arousal supports risk-related learning and, in turn, more advantageous decision-making and optimal behavior under conditions of risk.",2021,"We found that individuals on propranolol, relative to placebo, earned fewer points on the task, suggesting that they were less effective risk-takers.","['Eighty-seven adults (45% female, Mage= 20.1 ± 1.46 years) took either', 'n= 42), a beta-adrenergic receptor blocker that attenuates sympathetic nervous system-related signaling, or a placebo (n= 45']","['placebo', 'propranolol', 'Balloon Emotional Learning Task, a risk-taking task wherein experiential learning']",['effective risk-takers'],"[{'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C5191363', 'cui_str': '1.46'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0039044', 'cui_str': 'Sympathetic nervous system structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0582589', 'cui_str': 'Emotional learning'}, {'cui': 'C0035651', 'cui_str': 'Risk-Taking'}, {'cui': 'C0243012', 'cui_str': 'Active Learning'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",87.0,0.24277,"We found that individuals on propranolol, relative to placebo, earned fewer points on the task, suggesting that they were less effective risk-takers.","[{'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'MacCormack', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina, Chapel Hill, USA.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Armstrong-Carter', 'Affiliation': 'Graduate School of Education, Stanford University, USA.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Humphreys', 'Affiliation': 'Department of Psychology and Human Development, Vanderbilt University, USA.'}, {'ForeName': 'Keely A', 'Initials': 'KA', 'LastName': 'Muscatell', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina, Chapel Hill, USA.'}]",Social cognitive and affective neuroscience,['10.1093/scan/nsab047'] 4002,33860732,Intake of New Zealand Blackcurrant Powder Affects Skin-Borne Volatile Organic Compounds in Middle-Aged and Older Adults.,"Skin volatile organic compounds (VOCs) can cause body odor or reveal human disease and may result from lipid peroxidation or activity by skin bacteria. We examined the effect of intake of New Zealand blackcurrant (NZBC) powder for 77 skin VOCs in middle-aged and older adults in a crossover design. Fourteen adults (nine males, age: 55 ± 5 yrs) consumed NZBC powder for 7 days (6 g·day -1 with 138.6 mg anthocyanins). Two hours after the last intake, a passive flux sampler with trapping media was applied in the base of the neck for 1 hour. Gas chromatography-mass spectrometry was used for media analysis. Habitual anthocyanin intake was quantified using a food frequency questionnaire. Compared to control (i.e., no intake of NZBC powder), emission of six skin VOCs (i.e., 2-nonenal, acetic acid, 2-hexanone, 6-methyl-5-hepten-2-one, benzaldehyde, allyl methyl sulfide) were lower by more than 25%. Increases were observed for γ-octanolactone (+184%) and γ-decanolactone (+89%). A trend for a decrease for isovaleraldehyde, hexanal, and 2-pentanone, and an increase for heptanoic acid and γ-nonanolactone was observed. There was a significant correlation with daily habitual dietary anthocyanin intake for control values of hexanal and percentage change of γ-octanolactone. NZBC powder can change emanation of some VOCs in human skin. Analysis of skin VOCs following specific polyphenol intake may address the impact of dietary components to affect internal metabolic processes, body odor, and health.",2021,There was a significant correlation with daily habitual dietary anthocyanin intake for control values of hexanal and percentage change of γ-octanolactone.,"['Middle-Aged and Older Adults', '77 skin VOCs in middle-aged and older adults', 'Fourteen adults (nine males, age: 55\u2009±\u20095\u2009yrs) consumed']","['New Zealand blackcurrant (NZBC) powder', 'specific polyphenol intake', 'γ-decanolactone', 'NZBC powder for 7\u2009days (6\u2009g·day -1 with 138.6\u2009mg anthocyanins', 'Skin volatile organic compounds (VOCs', 'NZBC powder']","['Habitual anthocyanin intake', 'isovaleraldehyde, hexanal, and 2-pentanone', 'heptanoic acid and γ-nonanolactone', 'emission of six skin VOCs (i.e., 2-nonenal, acetic acid, 2-hexanone, 6-methyl-5-hepten-2-one, benzaldehyde, allyl methyl sulfide', 'daily habitual dietary anthocyanin intake']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C2350439', 'cui_str': 'Volatile Organic Compounds'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0453277', 'cui_str': 'Blackcurrants'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C2350439', 'cui_str': 'Volatile Organic Compounds'}]","[{'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0064097', 'cui_str': '3-methylbutanal'}, {'cui': 'C0068007', 'cui_str': 'Hexaldehyde'}, {'cui': 'C0653540', 'cui_str': '2-pentanone'}, {'cui': 'C0443770', 'cui_str': 'HEPTANOIC ACID'}, {'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C2350439', 'cui_str': 'Volatile Organic Compounds'}, {'cui': 'C0046464', 'cui_str': '2-nonenal'}, {'cui': 'C0000983', 'cui_str': 'Acetic Acid'}, {'cui': 'C0025708', 'cui_str': 'Butyl methyl ketone'}, {'cui': 'C0066385', 'cui_str': '6-methyl-5-hepten-2-one'}, {'cui': 'C0005023', 'cui_str': 'benzaldehyde'}, {'cui': 'C0654491', 'cui_str': 'allyl methyl sulfide'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]",14.0,0.0232738,There was a significant correlation with daily habitual dietary anthocyanin intake for control values of hexanal and percentage change of γ-octanolactone.,"[{'ForeName': 'M E T', 'Initials': 'MET', 'LastName': 'Willems', 'Affiliation': 'Institute of Sport, University of Chichester, Chichester, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Todaka', 'Affiliation': 'Graduate School of Science, Tokai University, Hiratsuka City, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Banic', 'Affiliation': 'Institute of Sport, University of Chichester, Chichester, UK.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Cook', 'Affiliation': 'Institute of Sport and Exercise Science, University of Worchester, Worcester, UK.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Sekine', 'Affiliation': 'Graduate School of Science, Tokai University, Hiratsuka City, Japan.'}]",Journal of dietary supplements,['10.1080/19390211.2021.1908479'] 4003,33860721,Effects of glucocorticoid and noradrenergic activity on implicit and explicit facial emotion recognition in healthy young men.,"The ability to recognize emotions from facial expressions is crucial for social interaction. Only few studies have examined the effect of stress hormones on facial emotion recognition, although stressful events affect social interactions on a daily basis. Those studies that examined facial emotion recognition mostly used explicit prompts to trigger consciously controlled processing. However, facial emotions are processed mainly implicitly in real life. Therefore, we investigated separate and combined effects of noradrenergic and glucocorticoid stimulation on implicit and explicit facial emotion recognition. One hundred and four healthy men (mean age = 24.1 years ± SD 3.5) underwent the Face Puzzle task to test implicit and explicit facial emotion recognition after receiving either 10 mg hydrocortisone or 10 mg yohimbine (an alpha 2-adrenergic receptor antagonist that increases noradrenergic activity) or 10 mg hydrocortisone/10 mg yohimbine combined or placebo. Salivary cortisol and salivary alpha amylase (sAA) were measured during the experiment. Compared to the placebo condition hydrocortisone significantly increased salivary cortisol and yohimbine significantly increased sAA. Participants were better and faster in explicit than in implicit facial emotion recognition. However, there was no effect of separate and combined noradrenergic and glucocorticoid stimulation on implicit and explicit facial emotion recognition performance compared to placebo. Our results do not support an essential role of the glucocorticoid and noradrenergic system in FER in young healthy men.",2021,"However, there was no effect of separate and combined noradrenergic and glucocorticoid stimulation on implicit and explicit facial emotion recognition performance compared to placebo.","['One hundred and four healthy men (mean age = 24.1\u2009years ± SD 3.5) underwent the Face Puzzle task to test implicit and explicit facial emotion recognition after receiving either 10\u2009mg', 'young healthy men', 'healthy young men']","['noradrenergic and glucocorticoid stimulation', 'hydrocortisone', 'placebo condition hydrocortisone', 'yohimbine', 'yohimbine combined or placebo', 'placebo', 'glucocorticoid and noradrenergic activity']","['Salivary cortisol and salivary alpha amylase (sAA', 'salivary cortisol', 'implicit and explicit facial emotion recognition', 'facial emotion recognition', 'implicit and explicit facial emotion recognition performance']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0423995', 'cui_str': 'Puzzled'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0724441', 'cui_str': 'yohimbine'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C2350322', 'cui_str': 'Salivary alpha-Amylases'}, {'cui': 'C0002723', 'cui_str': 'Serum amyloid A protein'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}]",104.0,0.0882506,"However, there was no effect of separate and combined noradrenergic and glucocorticoid stimulation on implicit and explicit facial emotion recognition performance compared to placebo.","[{'ForeName': 'Woo Ri', 'Initials': 'WR', 'LastName': 'Chae', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Berlin, Germany.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Metz', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Berlin, Germany.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Pantazidis', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Berlin, Germany.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Dziobek', 'Affiliation': 'Berlin School of Mind and Brain, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Hellmann-Regen', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Berlin, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wingenfeld', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Otte', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Berlin, Germany.'}]","Stress (Amsterdam, Netherlands)",['10.1080/10253890.2021.1908255'] 4004,33860709,Cannabidiol modulation of hippocampal glutamate in early psychosis.,"BACKGROUND Emerging evidence supports the antipsychotic effect of cannabidiol, a non-intoxicating component of cannabis, in people with psychosis. Preclinical findings suggest that this antipsychotic effect may be related to cannabidiol modulating glutamatergic signalling in the brain. AIM The purpose of this study was to investigate the effects of cannabidiol on the neurochemical mechanisms underlying psychosis. METHODS We investigated the effects of a single oral dose of cannabidiol (600 mg) in patients with psychosis, using a double-blind, randomised, placebo-controlled, repeated-measures, within-subject cross-over design. After drug administration, 13 patients were scanned using proton magnetic resonance spectroscopy to measure left hippocampal glutamate levels. Symptom severity was rated using the Positive and Negative Syndrome Scale 60 min before drug administration (pre-scan), and 270 min after drug administration (post-scan). Effects of cannabidiol on hippocampal glutamate levels, symptom severity, and correlations between hippocampal glutamate and symptoms were investigated. RESULTS Compared to placebo, there was a significant increase in hippocampal glutamate ( p =0.035), and a significantly greater decrease in symptom severity ( p =0.032) in the psychosis patients under cannabidiol treatment. There was also a significant negative relationship between post-treatment total Positive and Negative Syndrome Scale score and hippocampal glutamate ( p =0.047), when baseline Positive and Negative Syndrome Scale score, treatment (cannabidiol vs placebo), and interaction between treatment and glutamate levels were controlled for. CONCLUSIONS These findings may suggest a link between the increase in glutamate levels and concomitant decrease in symptom severity under cannabidiol treatment observed in psychosis patients. Furthermore, the findings provide novel insight into the potential neurochemical mechanisms underlying the antipsychotic effects of cannabidiol.",2021,"Compared to placebo, there was a significant increase in hippocampal glutamate ( p =0.035), and a significantly greater decrease in symptom severity ( p =0.032) in the psychosis patients under cannabidiol treatment.","['patients with psychosis', 'people with psychosis', 'early psychosis', 'psychosis patients', '13 patients were scanned using']","['placebo', 'proton magnetic resonance spectroscopy', 'hippocampal glutamate', 'cannabidiol']","['Symptom severity', 'hippocampal glutamate', 'hippocampal glutamate levels, symptom severity, and correlations between hippocampal glutamate and symptoms', 'glutamate levels', 'negative relationship between post-treatment total Positive and Negative Syndrome Scale score and hippocampal glutamate', 'baseline Positive and Negative Syndrome Scale score', 'symptom severity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3850002', 'cui_str': '1H-MRS'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",13.0,0.14662,"Compared to placebo, there was a significant increase in hippocampal glutamate ( p =0.035), and a significantly greater decrease in symptom severity ( p =0.032) in the psychosis patients under cannabidiol treatment.","[{'ForeName': 'Aisling', 'Initials': 'A', 'LastName': ""O'Neill"", 'Affiliation': ""Department of Psychosis Studies, King's College London, London, UK.""}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Annibale', 'Affiliation': ""Department of Psychosis Studies, King's College London, London, UK.""}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Blest-Hopley', 'Affiliation': ""Department of Psychosis Studies, King's College London, London, UK.""}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Wilson', 'Affiliation': ""Department of Psychosis Studies, King's College London, London, UK.""}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Giampietro', 'Affiliation': ""Department of Neuroimaging, King's College London, London, UK.""}, {'ForeName': 'Sagnik', 'Initials': 'S', 'LastName': 'Bhattacharyya', 'Affiliation': ""Department of Psychosis Studies, King's College London, London, UK.""}]","Journal of psychopharmacology (Oxford, England)",['10.1177/02698811211001107'] 4005,33860699,A mobile app that uses neurofeedback and multi-sensory learning methods improves reading abilities in dyslexia: A pilot study.,"Reading comprehension is difficult to improve for children with dyslexia because of the continuing demands of orthographic decoding in combination with limited working memory capacity. Children with dyslexia get special education that improves spelling, phonemic and vocabulary awareness, however the latest research indicated that special education does not improve reading comprehension. With the aim of improving reading comprehension, reading speed and all other reading abilities of children with dyslexia, Auto Train Brain that is a novel mobile app using neurofeedback and multi-sensory learning methods was developed. With a clinical study, we wanted to demonstrate the effectiveness of Auto Train Brain on reading abilities. We compared the cognitive improvements obtained with Auto Train Brain with the improvements obtained with special dyslexia training. Auto Train Brain was applied to 16 children with dyslexia 60 times for 30 minutes. The control group consisted of 14 children with dyslexia who did not have remedial training with Auto Train Brain, but who did continue special education. The TILLS test was applied to both the experimental and the control group at the beginning of the experiment and after a 6-month duration from the first TILLS test. Comparison of the pre- and post- TILLS test results indicated that applying neurofeedback and multi-sensory learning method improved reading comprehension of the experimental group more than that of the control group statistically significantly. Both Auto Train Brain and special education improved phonemic awareness and nonword spelling.",2021,TILLS test results indicated that applying neurofeedback and multi-sensory learning method improved reading comprehension of the experimental group more than that of the control group statistically significantly.,"['14 children with', 'Children with dyslexia get special education', 'children with dyslexia', '16 children with dyslexia 60 times for 30\u2009minutes', 'dyslexia', 'children with dyslexia, Auto Train Brain']","['pre- and post', 'dyslexia who did not have remedial training with Auto Train Brain, but who did continue special education']","['reading comprehension', 'spelling, phonemic and vocabulary awareness', 'reading abilities', 'phonemic awareness and nonword spelling']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0476254', 'cui_str': 'Dyslexia'}, {'cui': 'C0013649', 'cui_str': 'Special Education'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0476254', 'cui_str': 'Dyslexia'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0013649', 'cui_str': 'Special Education'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",14.0,0.0405536,TILLS test results indicated that applying neurofeedback and multi-sensory learning method improved reading comprehension of the experimental group more than that of the control group statistically significantly.,"[{'ForeName': 'Günet', 'Initials': 'G', 'LastName': 'Eroğlu', 'Affiliation': 'Department of Computer Engineering, Işık University, Istanbul, Turkey.'}, {'ForeName': 'Serap', 'Initials': 'S', 'LastName': 'Teber', 'Affiliation': 'Child Neurology Department, Medical Faculty, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Kardelen', 'Initials': 'K', 'LastName': 'Ertürk', 'Affiliation': 'HMS Health Mobile Software A.S, Kayseri, Turkey.'}, {'ForeName': 'Meltem', 'Initials': 'M', 'LastName': 'Kırmızı', 'Affiliation': 'Neuro Brain Academy, Izmir, Turkey.'}, {'ForeName': 'Barıs', 'Initials': 'B', 'LastName': 'Ekici', 'Affiliation': 'Özel Çocuk Nörolojisi Kliniği, Fulya, Istanbul, Turkey.'}, {'ForeName': 'Fehim', 'Initials': 'F', 'LastName': 'Arman', 'Affiliation': 'Neurology Department, Acıbadem Hastanesi Kadıköy, Istanbul, Turkey.'}, {'ForeName': 'Selim', 'Initials': 'S', 'LastName': 'Balcisoy', 'Affiliation': 'Department of Engineering and Natural Sciences, Sabancı University, İstanbul, Turkey.'}, {'ForeName': 'Yusuf Ziya', 'Initials': 'YZ', 'LastName': 'Özcan', 'Affiliation': 'HMS Health Mobile Software A.S, Kayseri, Turkey.'}, {'ForeName': 'Müjdat', 'Initials': 'M', 'LastName': 'Çetin', 'Affiliation': 'Department of Electrical and Computer Engineering, University of Rochester, Rochester, NY, USA.'}]",Applied neuropsychology. Child,['10.1080/21622965.2021.1908897'] 4006,33860689,Stress-responses to ostracism: Examining cortisol and affective reactivity to in-person and online exclusion.,"Ostracism is associated with poor outcomes, but it is unclear if online versus in-person ostracism elicits divergent psychological and physiological responses. Participants ( N  = 54) were randomly assigned to online or in-person ostracism, and provided pre- and post-ostracism measures of affect, self-esteem, self-feelings, and salivary cortisol. No significant changes in negative affect, self-esteem, or self-feelings emerged, nor were there differences by ostracism condition. Both ostracism conditions decreased positive affect (stronger online) and lowered cortisol. Extending prior work, ostracism appears to reliably decrease positive affect (especially online) but may not be threatening to the self; moreover, ostracism may reliably elicit acute cortisol declines.",2021,"No significant changes in negative affect, self-esteem, or self-feelings emerged, nor were there differences by ostracism condition.",['Participants ( N \u2009=\u200954'],[],"['negative affect, self-esteem, or self-feelings']",[],[],"[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}]",54.0,0.0269574,"No significant changes in negative affect, self-esteem, or self-feelings emerged, nor were there differences by ostracism condition.","[{'ForeName': 'Kelly B', 'Initials': 'KB', 'LastName': 'Filipkowski', 'Affiliation': 'Misericordia University, USA.'}, {'ForeName': 'Dusti R', 'Initials': 'DR', 'LastName': 'Jones', 'Affiliation': 'The Pennsylvania State University, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Bernstein', 'Affiliation': 'Penn State Abington, USA.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Smyth', 'Affiliation': 'The Pennsylvania State University, USA.'}]",Journal of health psychology,['10.1177/13591053211001411'] 4007,33860672,The effect of midodrine on lactate clearance in patients with septic shock: a pilot study.,"Background: The effect of midodrine on lactate clearance has not been assessed in critically ill patients yet. Objective: The goal of this study was to assess the effect of adjunctive midodrine therapy on lactate clearance in patients with septic shock. Materials & methods: Patients with septic shock were assigned to receive either adjunctive midodrine 10 mg three-times a day for 5 days (midodrine group = 15 patients) or not (control group = 13 patients). Results: The lactate clearance was significantly faster in the midodrine group than the control group (p = 0.049) with a large effect size ( η p 2  = 0.141). Conclusion: When midodrine was added to intravenous vasopressors, it significantly accelerated lactate clearance in patients with septic shock. Trial registration number: IRCT20100228003449N25 (Clinicaltrials.gov).",2021,The lactate clearance was significantly faster in the midodrine group than the control group (p = 0.049) with a large effect size ( η p 2  = 0.141). ,"['Patients with septic shock', 'patients with septic shock', 'critically ill patients yet']","['adjunctive midodrine therapy', 'midodrine', 'adjunctive midodrine 10']",['lactate clearance'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}]","[{'cui': 'C0026078', 'cui_str': 'Midodrine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",15.0,0.155684,The lactate clearance was significantly faster in the midodrine group than the control group (p = 0.049) with a large effect size ( η p 2  = 0.141). ,"[{'ForeName': 'Effat', 'Initials': 'E', 'LastName': 'Davoudi-Monfared', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Intensive Care Unit, Imam Khomeini Hospital, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Meysam', 'Initials': 'M', 'LastName': 'Khoshavi', 'Affiliation': 'Department of Cardiology, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Khalili', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}]",Journal of comparative effectiveness research,['10.2217/cer-2020-0238'] 4008,33860592,"Effects of an interprofessional communication approach on support needs, quality of life and mood of advanced lung cancer patients: a randomized trial.","BACKGROUND To address the support needs of newly diagnosed lung cancer patients with limited prognosis, the Milestone Communication Approach (MCA) was developed and implemented. Main elements of the MCA are situation-specific conversations along the disease trajectory conducted by an interprofessional tandem of physician and nurse. Aim of the study was to evaluate the effects of MCA on addressing support needs, quality of life and mood as compared to standard oncological care. PATIENTS AND METHODS A randomized trial was conducted with baseline assessment and follow-up assessments at 3, 6 and 9 months in out-patients with newly diagnosed lung cancer stage IV at a German thoracic oncology hospital. Primary outcome was the subscale Health System and Information Needs of the Short Form Supportive Care Needs Survey (SCNS-SF34-G) at 3-month follow-up. Secondary outcomes included the other subscales of the SCNS-SF34-G, the Schedule for the Evaluation of Individual Quality of Life (SEIQoL), the Functional Assessment of Chronic Illness Therapy (FACT-L), the Patient Health Questionnaire for Depression and Anxiety (PHQ-4) and the Distress Thermometer. RESULTS At baseline, 174 patients were randomized of whom 102 patients (MCA: n=52; standard care: n=50) provided data at 3-month follow-up. Patients of the MCA group reported lower information needs at 3-month follow-up (M=33.4, SD=27.5; standard care: M=43.1, SD=29.9, p=.033). No effects were found for secondary outcomes. CONCLUSION MCA lowered patient-reported information needs, but did not have other effects. MCA contributed to tailored communication, because an adequate level of information and orientation set the basis for patient-centered care. IMPLICATIONS FOR PRACTICE By addressing relevant issues at predefined times, the MCA is a tool to provide individual patient-centered care facilitating the timely integration of palliative care for patients with a limited prognosis. Needs of lung cancer patients have to be assessed and addressed throughout the disease trajectory. While specific topics are relevant at particular times for all patients, i.e. information about the disease and directly associated healthcare, individual situations of patients and their families need to be considered. Additionally, using the SCNS-SF34 in clinical practice to identify problems for which patients need help might support individually targeted communication and preference-sensitive care.",2021,"Patients of the MCA group reported lower information needs at 3-month follow-up (M=33.4, SD=27.5; standard care: M=43.1, SD=29.9, p=.033).","['lung cancer patients', '174 patients were randomized of whom 102 patients (MCA: n=52; standard care: n=50', 'newly diagnosed lung cancer patients with limited prognosis', 'patients with a limited prognosis', 'out-patients with newly diagnosed lung cancer stage IV at a German thoracic oncology hospital', 'advanced lung cancer patients']","['interprofessional communication approach', 'MCA']","['subscale Health System and Information Needs of the Short Form Supportive Care Needs Survey (SCNS-SF34-G', 'support needs, quality of life and mood', 'other subscales of the SCNS-SF34-G, the Schedule for the Evaluation of Individual Quality of Life (SEIQoL), the Functional Assessment of Chronic Illness Therapy (FACT-L), the Patient Health Questionnaire for Depression and Anxiety (PHQ-4) and the Distress Thermometer']","[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0855005', 'cui_str': 'Lung carcinoma cell type unspecified stage IV'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4524268', 'cui_str': 'Advanced lung cancer'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0039818', 'cui_str': 'Thermometer'}]",174.0,0.16989,"Patients of the MCA group reported lower information needs at 3-month follow-up (M=33.4, SD=27.5; standard care: M=43.1, SD=29.9, p=.033).","[{'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Krug', 'Affiliation': 'University Hospital Heidelberg, Dept. of General Practice and Health Services Research.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Bossert', 'Affiliation': 'University Hospital Heidelberg, Dept. of General Practice and Health Services Research.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Deis', 'Affiliation': 'University Hospital Heidelberg, Thoracic Clinic, Dept. of Thoracic Oncology, Translational Lung Research Center Heidelberg (TLRC-H), German Center for Lung Research (DZL).'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Krisam', 'Affiliation': 'University Hospital Heidelberg, Institute of Medical Biometry and Informatics.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Villalobos', 'Affiliation': 'University Hospital Heidelberg, Thoracic Clinic, Dept. of Thoracic Oncology, Translational Lung Research Center Heidelberg (TLRC-H), German Center for Lung Research (DZL).'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Siegle', 'Affiliation': 'University Hospital Heidelberg, Thoracic Clinic, Dept. of Thoracic Oncology, Translational Lung Research Center Heidelberg (TLRC-H), German Center for Lung Research (DZL).'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Jung', 'Affiliation': 'University Hospital Heidelberg, Thoracic Clinic, Dept. of Thoracic Oncology, Translational Lung Research Center Heidelberg (TLRC-H), German Center for Lung Research (DZL).'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hagelskamp', 'Affiliation': 'University Hospital Heidelberg, Thoracic Clinic, Dept. of Thoracic Oncology, Translational Lung Research Center Heidelberg (TLRC-H), German Center for Lung Research (DZL).'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Unsöld', 'Affiliation': 'University Hospital Heidelberg, Thoracic Clinic, Dept. of Thoracic Oncology, Translational Lung Research Center Heidelberg (TLRC-H), German Center for Lung Research (DZL).'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Jünger', 'Affiliation': 'German National Institute for State Examinations in Medicine, Pharmacy and Psychotherapy, Mainz.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'University Hospital Heidelberg, Thoracic Clinic, Dept. of Thoracic Oncology, Translational Lung Research Center Heidelberg (TLRC-H), German Center for Lung Research (DZL).'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Wensing', 'Affiliation': 'University Hospital Heidelberg, Dept. of General Practice and Health Services Research.'}]",The oncologist,['10.1002/onco.13790'] 4009,33860587,The effect of propolis plus Hyoscyamus niger L. methanolic extract on clinical symptoms in patients with acute respiratory syndrome suspected to COVID-19: A clinical trial.,"The outbreak of Coronavirus disease 2019 (COVID-19) has caused a global health crisis. Nevertheless, no antiviral treatment has yet been proven effective for treating COVID-19 and symptomatic supportive cares have been the most common treatment. Therefore, the present study was designed to evaluate the effects of propolis and Hyoscyamus niger L. extract in patients with COVID-19. This randomized clinical trial was conducted on 50 cases referred to Akhavan and Sepehri Clinics, Kashan university of medical sciences, Iran. Subjects were divided into two groups (intervention and placebo). This syrup (containing 1.6 mg of methanolic extract along with 450 mg of propolis per 10 mL) was administered three times a day to each patient for 6 days. The clinical symptoms of COVID-19 such as: dry cough, shortness of breath, sore throat, chest pain, fever, dizziness, headache, abdominal pain, and diarrhea were reduced with propolis plus Hyoscyamus niger L. extract than the placebo group. However, the administration of syrup was not effective in the control of nausea and vomiting. In conclusion, syrup containing propolis and Hyoscyamus niger L. extract had beneficial effects in ameliorating the signs and symptoms of COVID-19 disease, in comparison with placebo groups.",2021,"However, the administration of syrup was not effective in the control of nausea and vomiting.","['patients with COVID-19', 'patients with acute respiratory syndrome suspected to COVID-19', '50 cases referred to Akhavan and Sepehri Clinics, Kashan university of medical sciences, Iran']","['placebo', 'propolis plus Hyoscyamus niger L. methanolic extract', 'methanolic extract']","['clinical symptoms', 'nausea and vomiting', 'clinical symptoms of COVID-19 such as: dry cough, shortness of breath, sore throat, chest pain, fever, dizziness, headache, abdominal pain, and diarrhea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0331199', 'cui_str': 'Hyoscyamus'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0850149', 'cui_str': 'Dry cough'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",50.0,0.163856,"However, the administration of syrup was not effective in the control of nausea and vomiting.","[{'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Kosari', 'Affiliation': 'Department of Biology, Science and Research Branch, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Noureddini', 'Affiliation': 'Physiology Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Seyed Peyman', 'Initials': 'SP', 'LastName': 'Khamechi', 'Affiliation': 'Department of Persian Medicine, School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Najafi', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kashan University of Medical sciences, Kashan, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Ghaderi', 'Affiliation': 'Clinical Research Development Unit-Matini/Kargarnejad Hospital, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Sehat', 'Affiliation': 'Trauma Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Banafshe', 'Affiliation': 'Physiology Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.7116'] 4010,33860553,A randomized controlled evaluation of an educational resource to address fertility concerns after cancer.,"OBJECTIVE This study evaluated the acceptability and impact of a written oncofertility educational resource (ER), as a self-help intervention (SH), and as an adjunct to a one-hour health-care professional discussion (HP). METHODS Within a randomized control trial (RCT), 194 adults with cancer (175 women; 19 men) were allocated to the SH or HP intervention. 127 completed 6-week post-intervention measures, a retention rate of 65.85%. RESULTS Across interventions, the ER was rated as highly acceptable and useful, in terms of ease of understanding, and information. Heath literacy significantly increased post-intervention, including functional literacy, communicative literacy, and critical health literacy. There were no significant changes in ratings of fertility distress or general distress pre-post intervention. Quality of life was significantly reduced post intervention. Those in the HP condition reported higher quality of life and greater likelihood of communication with others about fertility, most notably with intimate partners, post-intervention. Qualitative identification of increased knowledge, confidence with communication and normalization of fertility concerns, reflects increased health literacy, and provides explanation for significant reductions in feeling nervous and fearful about fertility treatments post-intervention. CONCLUSIONS Our findings confirm the importance of information provision about the impact of cancer on fertility. Written ERs are a useful adjunct to a patient-clinician discussion, increasing health literacy, which facilitates knowledge, self-efficacy and management of fertility concerns and changes. This article is protected by copyright. All rights reserved.",2021,"Heath literacy significantly increased post-intervention, including functional literacy, communicative literacy, and critical health literacy.",['194 adults with cancer (175 women; 19 men'],"['written oncofertility educational resource (ER', 'educational resource', 'SH or HP intervention']","['quality of life', 'ratings of fertility distress', 'retention rate', 'Quality of life', 'functional literacy, communicative literacy, and critical health literacy']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}]",194.0,0.0283166,"Heath literacy significantly increased post-intervention, including functional literacy, communicative literacy, and critical health literacy.","[{'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Ussher', 'Affiliation': 'Translational Health Research Institute, School of Medicine, Western Sydney University.'}, {'ForeName': 'Janette', 'Initials': 'J', 'LastName': 'Perz', 'Affiliation': 'Translational Health Research Institute, School of Medicine, Western Sydney University.'}, {'ForeName': 'Alexandra J', 'Initials': 'AJ', 'LastName': 'Hawkey', 'Affiliation': 'Translational Health Research Institute, School of Medicine, Western Sydney University.'}]",Psycho-oncology,['10.1002/pon.5703'] 4011,33860484,Early double-guidewire versus repeated single-guidewire technique to facilitate selective bile duct cannulation: a randomized controlled trial.,"BACKGROUND During endoscopic retrograde cholangiopancreatography (ERCP), access to the common bile duct (CBD) can be problematic after unintentional insertion of the guidewire into the pancreatic duct. We conducted a prospective, randomized study in order to compare biliary cannulation success rates of early double-guidewire (EDG) and repeated single-guidewire (RSG) techniques in patients with inadvertent passage of the guidewire into the pancreatic duct. METHODS Patients with a native papilla were randomly assigned to either the EDG or RSG groups after unintentional insertion of the guidewire into the pancreatic duct. The primary outcome was successful selective CBD cannulation within 10 minutes. The secondary outcomes were successful final selective bile duct cannulation, time to bile duct cannulation, and frequency of post-ERCP pancreatitis (PEP). RESULTS 142 patients were randomized and selective bile duct cannulation was achieved in 57/68 patients (84 %) in the EDG group and in 37/74 patients (50 %) in the RSG group within 10 minutes (relative risk 1.34; 95 % confidence interval 1.08-6.18; P  < 0.001). The overall final selective bile duct cannulation rate was 99.3 %. The time to access the CBD was shorter using the EDG technique (6.0 vs. 10.4 minutes; P  = 0.002). Mild PEP was not observed more frequently in the EDG group than in the RSG group. CONCLUSION The EDG technique significantly increased the success rate of biliary duct cannulation within 10 minutes compared with an RSG approach.",2021,The EDG technique significantly increased the success rate of biliary duct cannulation within 10 minutes compared with an RSG approach.,"['patients with inadvertent passage of the guidewire into the pancreatic duct', 'Patients with a native papilla', '142 patients']","['EDG or RSG', 'Early double-guidewire versus repeated single-guidewire technique', 'early double-guidewire (EDG) and repeated single-guidewire (RSG) techniques', 'endoscopic retrograde cholangiopancreatography (ERCP']","['selective bile duct cannulation', 'successful final selective bile duct cannulation, time to bile duct cannulation, and frequency of post-ERCP pancreatitis (PEP', 'Mild PEP', 'successful selective CBD cannulation', 'success rate of biliary duct cannulation', 'time to access the CBD', 'overall final selective bile duct cannulation rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0181089', 'cui_str': 'Guide wire'}, {'cui': 'C0030288', 'cui_str': 'Pancreatic duct structure'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0226964', 'cui_str': 'Structure of lingual papillae'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0181089', 'cui_str': 'Guide wire'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}]","[{'cui': 'C0005400', 'cui_str': 'Bile duct structure'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0009437', 'cui_str': 'Common bile duct structure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",142.0,0.0821272,The EDG technique significantly increased the success rate of biliary duct cannulation within 10 minutes compared with an RSG approach.,"[{'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Laquière', 'Affiliation': 'Department of Gastroenterology, Saint Joseph Hospital, Marseille, France.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Privat', 'Affiliation': 'Department of Gastroenterology, Jacques Lacarin Hospital, Vichy, France.'}, {'ForeName': 'Jeremie', 'Initials': 'J', 'LastName': 'Jacques', 'Affiliation': 'Department of Endoscopy and Gastroenterology, Dupuytren Hospital, Limoges, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Legros', 'Affiliation': 'Department of Endoscopy and Gastroenterology, Dupuytren Hospital, Limoges, France.'}, {'ForeName': 'Romina', 'Initials': 'R', 'LastName': 'Urena-Campos', 'Affiliation': 'Department of Gastroenterology, Saint Joseph Hospital, Marseille, France.'}, {'ForeName': 'Hichem', 'Initials': 'H', 'LastName': 'Belkhodja', 'Affiliation': 'Digestive Endoscopy Unit, University Hospital Lyon Sud, Lyon, France.'}, {'ForeName': 'Clément', 'Initials': 'C', 'LastName': 'Subtil', 'Affiliation': 'Digestive Endoscopy Unit, University Hospital, Bordeaux, France.'}, {'ForeName': 'Leïla', 'Initials': 'L', 'LastName': 'Kanafi', 'Affiliation': 'Department of Gastroenterology, Groupe Polyclinique Marzet-Navarre, Pau, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Lecomte', 'Affiliation': 'Department of Gastroenterology, Saint Joseph Hospital, Marseille, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Boustière', 'Affiliation': 'Department of Gastroenterology, Saint Joseph Hospital, Marseille, France.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Katsogiannou', 'Affiliation': 'Department of Clinical Research, Saint Joseph Hospital, Marseille, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Karsenti', 'Affiliation': 'Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France.'}]",Endoscopy,['10.1055/a-1395-7485'] 4012,33860476,No Influence of Nonivamide-nicoboxil on the Peak Power Output in Competitive Sportsmen.,"Recent studies have shown that the oxygenated hemoglobin level can be enhanced during rest through the application of nonivamide-nicoboxil cream. However, the effect of nonivamide-nicoboxil cream on oxygenation and endurance performance under hypoxic conditions is unknown. Therefore, the purpose of this study was to investigate the effects of nonivamide-nicoboxil cream on local muscle oxygenation and endurance performance under normoxic and hypoxic conditions. In a cross-over design, 13 athletes (experienced cyclists or triathletes [age: 25.2±3.5 years; VO 2 max 62.1±7.3 mL·min -1 ·kg -1 ]) performed four incremental exercise tests on the cycle ergometer under normoxic or hypoxic conditions, either with nonivamide-nicoboxil or placebo cream. Muscle oxygenation was recorded with near-infrared spectroscopy. Capillary blood samples were taken after each step, and spirometric data were recorded continuously. The application of nonivamide-nicoboxil cream increased muscle oxygenation at rest and during different submaximal workloads as well as during physical exhaustion, irrespective of normoxic or hypoxic conditions. Overall, there were no significant effects of nonivamide-nicoboxil on peak power output, maximal oxygen uptake or lactate concentrations. Muscle oxygenation is significantly higher with the application of nonivamide-nicoboxil cream. However, its application does not increase endurance performance.",2021,"Overall, there were no significant effects of nonivamide-nicoboxil on peak power output, maximal oxygen uptake or lactate concentrations.",['13 athletes (experienced cyclists or triathletes [age: 25.2±3.5 years; VO 2 max 62.1±7.3\u2009mL·min -1 ·kg -1 ]) performed four'],"['incremental exercise tests on the cycle ergometer under normoxic or hypoxic conditions, either with nonivamide-nicoboxil or placebo cream', 'Nonivamide-nicoboxil', 'nonivamide-nicoboxil cream']","['peak power output, maximal oxygen uptake or lactate concentrations', 'oxygenation and endurance performance', 'muscle oxygenation', 'local muscle oxygenation and endurance performance under normoxic and hypoxic conditions', 'endurance performance', 'Muscle oxygenation']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0068942', 'cui_str': 'nonivamide'}, {'cui': 'C0770962', 'cui_str': 'nicoboxil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0700385', 'cui_str': 'Cream'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",13.0,0.0500917,"Overall, there were no significant effects of nonivamide-nicoboxil on peak power output, maximal oxygen uptake or lactate concentrations.","[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Schörkmaier', 'Affiliation': 'Department of Clinical Research, German Centre for Neurodegenerative Diseases, Bonn, Germany.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Wahl', 'Affiliation': 'Insitute of Exercise Training and Sport Informatics, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Brinkmann', 'Affiliation': 'Department of Preventive and Rehabilitative Sport Medicine, Institute of Cardiovascular Research and Sport Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Bloch', 'Affiliation': 'The German Research Centre of Elite Sport, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Wahl', 'Affiliation': 'The German Research Centre of Elite Sport, German Sport University Cologne, Cologne, Germany.'}]",International journal of sports medicine,['10.1055/a-1403-2701'] 4013,33860389,Trastuzumab emtansine (T-DM1) versus trastuzumab in Chinese patients with residual invasive disease after neoadjuvant chemotherapy and HER2-targeted therapy for HER2-positive breast cancer in the phase 3 KATHERINE study.,"PURPOSE In the KATHERINE study (NCT01772472), patients with HER2-positive early breast cancer (EBC) and residual invasive disease after neoadjuvant chemotherapy plus HER2-targeted therapy who were treated with adjuvant trastuzumab emtansine (T-DM1) had a 50% reduction in the risk of an invasive disease-free survival (IDFS) event compared to patients treated with adjuvant trastuzumab. In metastatic disease, T-DM1 has resulted in higher rates of thrombocytopenia in Asian versus non-Asian patients. Here, we report safety and efficacy in Chinese patients from KATHERINE. METHODS Patients with HER2-positive EBC and residual invasive disease after taxane- and trastuzumab-containing neoadjuvant chemotherapy followed by surgery were randomized 1:1 to 14 cycles of adjuvant T-DM1 or trastuzumab. The primary endpoint was time to an IDFS event. RESULTS Among Chinese patients (T-DM1 n = 51, trastuzumab n = 50), T-DM1 treatment resulted in a 43% reduction in risk of an IDFS event compared to trastuzumab (HR = 0.57; 95% CI 0.25-1.31), with similar results for secondary endpoints. As in the global population, Chinese patients receiving T-DM1 versus trastuzumab had more grade ≥ 3 adverse events (AEs; 39.2% versus 4.1%) and AEs leading to treatment discontinuation (27.5% versus 0%). The most common grade ≥ 3 AE with T-DM1 was thrombocytopenia (21.6%), a frequency higher than the frequency in the global population (5.7%). Grade ≥ 3 hemorrhage was reported in 1 patient (T-DM1 arm). CONCLUSIONS In the KATHERINE study, T-DM1 demonstrated increased efficacy compared to trastuzumab in Chinese patients. Consistent with previous data in Asian patients, T-DM1 was associated with more grade ≥ 3 AEs, and AEs leading to discontinuation, which was driven by an increase in thrombocytopenia.",2021,"In metastatic disease, T-DM1 has resulted in higher rates of thrombocytopenia in Asian versus non-Asian patients.","['patients with HER2-positive early breast cancer (EBC) and residual invasive disease after neoadjuvant chemotherapy plus HER2-targeted therapy who were treated with', 'Chinese patients from KATHERINE', 'Chinese patients', 'Chinese patients with residual invasive disease after neoadjuvant chemotherapy and HER2-targeted therapy for HER2-positive breast cancer', 'Patients with HER2-positive EBC and residual invasive disease after taxane- and trastuzumab-containing neoadjuvant chemotherapy followed by surgery']","['adjuvant trastuzumab emtansine (T-DM1', 'trastuzumab', 'Trastuzumab emtansine (T-DM1) versus trastuzumab', 'adjuvant trastuzumab', 'adjuvant T-DM1 or trastuzumab']","['Grade\u2009≥', 'safety and efficacy', 'time to an IDFS event', 'risk of an IDFS event', 'efficacy', 'risk of an invasive disease-free survival (IDFS) event', 'thrombocytopenia', '3 hemorrhage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C2935436', 'cui_str': 'ado-trastuzumab emtansine'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",,0.189065,"In metastatic disease, T-DM1 has resulted in higher rates of thrombocytopenia in Asian versus non-Asian patients.","[{'ForeName': 'Chiun-Sheng', 'Initials': 'CS', 'LastName': 'Huang', 'Affiliation': 'National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Youngsen', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Taichung Veterans General Hospital and School of Medicine, China Medical University, Taichung City, Taiwan.'}, {'ForeName': 'Ava', 'Initials': 'A', 'LastName': 'Kwong', 'Affiliation': 'Queen Mary Hospital, The University of Hong Kong, Pok Fu Lam, Hong Kong.'}, {'ForeName': 'Shin-Cheh', 'Initials': 'SC', 'LastName': 'Chen', 'Affiliation': 'Chang Gung Memorial Hospital, Chang Gung University Medical College, Taoyuan, Taiwan.'}, {'ForeName': 'Ling-Ming', 'Initials': 'LM', 'LastName': 'Tseng', 'Affiliation': 'Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Mei-Ching', 'Initials': 'MC', 'LastName': 'Liu', 'Affiliation': 'Koo Foundation Sun Yat-Sen Cancer Center, Taipei, Taiwan.'}, {'ForeName': 'Kunwei', 'Initials': 'K', 'LastName': 'Shen', 'Affiliation': 'Shanghai Jiaotong University School of Medicine, Ruijin Hospital, Shanghai, China.'}, {'ForeName': 'Shusen', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Sun Yat-Sen University Cancer Center, Guangdong Sheng, China.'}, {'ForeName': 'Ting-Ying', 'Initials': 'TY', 'LastName': 'Ng', 'Affiliation': 'Tuen Mun Hospital, Tuen Mun, Hong Kong.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Roche (China) Holding Ltd., Shanghai, China.'}, {'ForeName': 'Guofang', 'Initials': 'G', 'LastName': 'Sun', 'Affiliation': 'Roche (China) Holding Ltd., Shanghai, China.'}, {'ForeName': 'Iris Renfei', 'Initials': 'IR', 'LastName': 'Yan', 'Affiliation': 'Roche (China) Holding Ltd., Shanghai, China.'}, {'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Shao', 'Affiliation': 'Fudan University Shanghai Cancer Center, No. 270, Dongan Road, Shanghai, 200032, China. zhimingshao@yahoo.com.'}]",Breast cancer research and treatment,['10.1007/s10549-021-06166-y'] 4014,33860388,ANETT: PhAse II trial of NEoadjuvant TAK-228 plus Tamoxifen in patients with hormone receptor-positive breast cancer.,"INTRODUCTION Neoadjuvant endocrine therapy is often utilized to downstage Estrogen Receptor-positive (ER+) breast cancer prior to surgery. However, this approach is sometimes met with endocrine resistance mechanisms within the tumor. This trial examines the safety and efficacy of tamoxifen in combination with an mTORC1/2 inhibitor, TAK-228, in the neoadjuvant treatment of ER+ breast cancer. METHODS In this single-arm, open-label trial, pre- and post-menopausal women were enrolled to receive neoadjuvant tamoxifen (20 mg daily) with TAK-228 (30 mg weekly) for 16 weeks prior to surgery. Patient had tissue sampling at baseline, week 6, and week 16. The primary endpoint was change in Ki-67 from baseline to 6 weeks. The toxicity, change in tumor size, pathologic complete response rate, PEPI score, and baseline Oncotype Dx score were also assessed. RESULTS Twenty-eight women were enrolled on the trial, and 25 completed the entire study course. The combination of tamoxifen and TAK-228 resulted in a significant reduction in Ki-67 from 18.3 to 15.2% (p = 0.0023). The drug was also found to be safe and tolerable. While nausea and hyperglycemia were common side effects, these were manageable. The tumor size also significantly decreased with the treatment, with a median decrease of 0.75 cm (p < 0.0001). There were no pathologic complete responses. CONCLUSION Tamoxifen and TAK-228 was safe and well tolerated neoadjuvant treatment for ER+ breast cancer, preliminary evidence of activity with significant reduction in both Ki-67 and tumor size, warranting further evaluation in a larger study.",2021,"The tumor size also significantly decreased with the treatment, with a median decrease of 0.75 cm (p < 0.0001).","['ER+ breast cancer', 'pre- and post-menopausal women', 'patients with hormone receptor-positive breast cancer', 'Twenty-eight women were enrolled on the trial, and 25 completed the entire study course']","['TAK-228', 'neoadjuvant tamoxifen', 'Tamoxifen and TAK-228', 'NEoadjuvant TAK-228 plus Tamoxifen', 'tamoxifen and TAK-228', 'tamoxifen', 'Neoadjuvant endocrine therapy']","['toxicity, change in tumor size, pathologic complete response rate, PEPI score, and baseline Oncotype Dx score', 'change in Ki-67', 'Ki-67', 'pathologic complete responses', 'tumor size', 'safe and tolerable', 'nausea and hyperglycemia']","[{'cui': 'C2938924', 'cui_str': 'Oestrogen receptor positive breast cancer'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C2983747', 'cui_str': 'INK128'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C1453193', 'cui_str': 'GRN protein, human'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",28.0,0.220232,"The tumor size also significantly decreased with the treatment, with a median decrease of 0.75 cm (p < 0.0001).","[{'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Koca', 'Affiliation': 'Houston Methodist Cancer Center, Houston, TX, USA. dr.emrekoca@gmail.com.'}, {'ForeName': 'Polly Ann', 'Initials': 'PA', 'LastName': 'Niravath', 'Affiliation': 'Houston Methodist Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Ensor', 'Affiliation': 'Houston Methodist Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Tejal Amar', 'Initials': 'TA', 'LastName': 'Patel', 'Affiliation': 'Houston Methodist Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Xiaoxian', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Pej', 'Initials': 'P', 'LastName': 'Hemati', 'Affiliation': 'Houston Methodist Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': 'Houston Methodist Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Qian', 'Affiliation': 'Houston Methodist Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Toniva', 'Initials': 'T', 'LastName': 'Boone', 'Affiliation': 'Houston Methodist Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Priya V', 'Initials': 'PV', 'LastName': 'Ramshesh', 'Affiliation': 'Houston Methodist Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Adam Louis', 'Initials': 'AL', 'LastName': 'Cohen', 'Affiliation': 'Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Asha', 'Initials': 'A', 'LastName': 'Murthy', 'Affiliation': 'Houston Methodist Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Sindhu', 'Initials': 'S', 'LastName': 'Nair', 'Affiliation': 'Houston Methodist Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jorge German', 'Initials': 'JG', 'LastName': 'Darcourt', 'Affiliation': 'Houston Methodist Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Belcheva', 'Affiliation': 'Houston Methodist Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Virginia G', 'Initials': 'VG', 'LastName': 'Kaklamani', 'Affiliation': 'UT Health, San Antonio, TX, USA.'}, {'ForeName': 'Jenny Chee Ning', 'Initials': 'JCN', 'LastName': 'Chang', 'Affiliation': 'Houston Methodist Cancer Center, Houston, TX, USA.'}]",Breast cancer research and treatment,['10.1007/s10549-021-06214-7'] 4015,33860323,Quasilobar minimalist lung volume reduction surgery.,"OBJECTIVES Our goal was to assess the results and the costs of the quasilobar minimalist (QLM) thoracoscopic lung volume reduction (LVR) surgical method developed to minimize the trauma from the operation and the anaesthesia and to maximize the effect of the lobar volume reduction. METHODS Forty patients with severe emphysema underwent QLM-LVR that entailed adoption of sole intercostal block analgesia and lobar plication through a single thoracoscopic incision. Results were compared after propensity matching with 2 control groups undergoing non-awake resectional LVR with double-lumen tracheal intubation or awake non-resectional LVR by plication with thoracic epidural anaesthesia. As a result, we had 3 matched groups of 30 patients each. RESULTS Baseline forced expiratory volume in 1 s, residual volume, the 6-min walking test and the modified Medical Research Council dyspnoea index were 0.77 ± 0.18, 4.97 ± 0.6, 328 ± 65 and 3.3 ± 0.7, respectively, with no intergroup difference after propensity score matching. The visual pain score was better (P < 0.007), the hospital stay was shorter (P < 0.04) and overall costs were lower (P < 0.04) in the QLM-LVR group than in the control groups. The morbidity rate was lower with QLM-LVR than with non-awake resectional-LVR (P = 0.006). Significant improvements (P < 0.001) occurred in all study groups during the follow-up period. At 24 months, improvements in residual volume and dyspnoea index were significantly better with QLM-LVR (P < 0.04). CONCLUSIONS QLM-LVR proved safe and showed better perioperative outcomes and lower procedure-related costs than the control groups. Similar clinical benefit occurred at 12 months, but absolute improvements in residual volume and dyspnoea index were better in the QLM-LVR group at 24 months.",2021,"CONCLUSIONS QLM-LVR proved safe and showed better perioperative outcomes and lower procedure-related costs than the control groups.","['had 3 matched groups of 30 patients each', 'Forty patients with severe emphysema underwent']","['quasilobar minimalist (QLM) thoracoscopic lung volume reduction (LVR) surgical method', 'QLM-LVR that entailed adoption of sole intercostal block analgesia and lobar plication through a single thoracoscopic incision', 'double-lumen tracheal intubation or awake non-resectional LVR by plication with thoracic epidural anaesthesia']","['residual volume and dyspnoea index', 'visual pain score', 'overall costs', 'hospital stay', 'Baseline forced expiratory volume in 1\u2009s, residual volume, the 6-min walking test and the modified Medical Research Council dyspnoea index', 'morbidity rate']","[{'cui': 'C0024908', 'cui_str': 'Matched Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0013990', 'cui_str': 'Emphysema'}]","[{'cui': 'C0524689', 'cui_str': 'Lung Volume Reduction'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}]","[{'cui': 'C0035190', 'cui_str': 'Residual respiratory volume'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",40.0,0.0521496,"CONCLUSIONS QLM-LVR proved safe and showed better perioperative outcomes and lower procedure-related costs than the control groups.","[{'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Pompeo', 'Affiliation': 'Department of Thoracic Surgery, Tor Vergata University of Rome, Rome, Italy.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elkhouly', 'Affiliation': 'Department of Cardiothoracic Surgery, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Rogliani', 'Affiliation': 'Department of Respiratory Medicine, Tor Vergata University of Rome, Rome, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Dauri', 'Affiliation': 'Department of Anesthesia and Intensive Care, Tor Vergata University of Rome, Rome, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Peer', 'Affiliation': 'Department of Thoracic Surgery, Ichilov Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Gianluigi', 'Initials': 'G', 'LastName': 'Sergiacomi', 'Affiliation': 'Department of Radiology, Tor Vergata University of Rome, Rome, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Sorge', 'Affiliation': 'Department of Biostatistics, Tor Vergata University of Rome, Rome, Italy.'}]",European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery,['10.1093/ejcts/ezab174'] 4016,33860185,Acute and Sustained Reductions in Loss of Meaning and Suicidal Ideation Following Psilocybin-Assisted Psychotherapy for Psychiatric and Existential Distress in Life-Threatening Cancer.,"People with advanced cancer are at heightened risk of desire for hastened death (DHD), suicidal ideation (SI), and completed suicide. Loss of Meaning (LoM), a component of demoralization, can be elevated by a cancer diagnosis and predicts DHD and SI in this population. We completed a randomized controlled trial in which psilocybin-assisted psychotherapy (PAP) produced rapid and sustained improvements in depression, demoralization, and hopelessness in people with cancer. Converging epidemiologic and clinical trial findings suggests a potential antisuicidal effect of this treatment. To probe our hypothesis that PAP relieves SI through its beneficial impacts on depression and demoralization (LoM in particular), we performed secondary analyses assessing within- and between-group differences with regard to LoM and an SI composite score. Among participants with elevated SI at baseline, PAP was associated with within-group reductions in SI that were apparent as early as 8 h and persisted for 6.5 months postdosing. PAP also produced large reductions in LoM from baseline that were apparent 2 weeks after treatment and remained significant and robust at the 6.5 month and 3.2 and 4.5 year follow-ups. Exploratory analyses support our hypothesis and suggest that PAP may be an effective antisuicidal intervention following a cancer diagnosis due to its positive impact on hopelessness and demoralization and its effects on meaning-making in particular. These preliminary results implicate psilocybin treatment as a potentially effective alternative to existing antidepressant medications in patients with cancer that are also suicidal, and warrant further investigation in participants with elevated levels of depression and suicidality.",2021,PAP also produced large reductions in LoM from baseline that were apparent 2 weeks after treatment and remained significant and robust at the 6.5 month and 3.2 and 4.5 year follow-ups.,"['People with advanced cancer', 'patients with cancer', 'people with cancer']","['Psilocybin-Assisted Psychotherapy', 'psilocybin-assisted psychotherapy (PAP', 'psilocybin']","['depression, demoralization, and hopelessness', 'Loss of Meaning (LoM', 'Loss of Meaning and Suicidal Ideation', 'hastened death (DHD), suicidal ideation (SI']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0233498', 'cui_str': 'Demoralization'}, {'cui': 'C0150041', 'cui_str': 'Feeling hopeless'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.23498,PAP also produced large reductions in LoM from baseline that were apparent 2 weeks after treatment and remained significant and robust at the 6.5 month and 3.2 and 4.5 year follow-ups.,"[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Ross', 'Affiliation': 'NYU Langone Health Center for Psychedelic Medicine, 462 First Avenue, New York, New York, 10016, United States.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Agin-Liebes', 'Affiliation': 'University of California, San Francisco, Department of Psychiatry & Behavioral Sciences, San Francisco, California, 94110, United States.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Lo', 'Affiliation': 'Pacific University College of Health Professions, Hillsboro, Oregon 97123-4218, United States.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Zeifman', 'Affiliation': 'Ryerson University, Toronto, Ontario M5B 2K3, Canada.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Ghazal', 'Affiliation': 'NYU Langone Health Center for Psychedelic Medicine, 462 First Avenue, New York, New York, 10016, United States.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Benville', 'Affiliation': 'NYU Langone Health Center for Psychedelic Medicine, 462 First Avenue, New York, New York, 10016, United States.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Franco Corso', 'Affiliation': 'Columbia University, Department of Psychiatry, New York State Psychiatric Institute, New York, New York, 10032-3784, United States.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Bjerre Real', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York, 10065-6007, United States.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Guss', 'Affiliation': 'NYU Langone Health Center for Psychedelic Medicine, 462 First Avenue, New York, New York, 10016, United States.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Bossis', 'Affiliation': 'NYU Langone Health Center for Psychedelic Medicine, 462 First Avenue, New York, New York, 10016, United States.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Mennenga', 'Affiliation': 'NYU Langone Health Center for Psychedelic Medicine, 462 First Avenue, New York, New York, 10016, United States.'}]",ACS pharmacology & translational science,['10.1021/acsptsci.1c00020'] 4017,33860177,Set and Setting: A Randomized Study of Different Musical Genres in Supporting Psychedelic Therapy.,"Mounting evidence supports the serotonin 2A receptor agonist psilocybin as a psychiatric pharmacotherapy. Little research has experimentally examined how session ""set and setting"" impacts subjective and therapeutic effects. We analyzed the effects of the musical genre played during sessions of a psilocybin study for tobacco smoking cessation. Participants ( N = 10) received psilocybin (20-30 mg/70 kg) in two sessions, each with a different musical genre (Western classical versus overtone-based), with the order counterbalanced. Participants chose one genre for a third session (30 mg/70 kg). Mystical experiences scores tended to be higher in overtone-based sessions than in Western classical sessions. Six of ten participants chose the overtone-based music for a third session. Biologically confirmed smoking abstinence was similar based on musical choice, with a slight benefit for participants choosing the overtone-based playlist (66.7% versus 50%). These data call into question whether Western classical music typically used in psychedelic therapy holds a unique benefit. Broadly, we call for experimentally examining session components toward optimizing psychedelic therapeutic protocols.",2021,"Biologically confirmed smoking abstinence was similar based on musical choice, with a slight benefit for participants choosing the overtone-based playlist (66.7% versus 50%).",[],"['psilocybin', 'musical genre (Western classical versus overtone-based']","['Mystical experiences scores', 'smoking abstinence']",[],"[{'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]",,0.0315632,"Biologically confirmed smoking abstinence was similar based on musical choice, with a slight benefit for participants choosing the overtone-based playlist (66.7% versus 50%).","[{'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'Strickland', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, 5510 Nathan Shock Drive, Baltimore, Maryland 21224, United States.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Garcia-Romeu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, 5510 Nathan Shock Drive, Baltimore, Maryland 21224, United States.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Johnson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, 5510 Nathan Shock Drive, Baltimore, Maryland 21224, United States.'}]",ACS pharmacology & translational science,['10.1021/acsptsci.0c00187'] 4018,33860175,Low Doses of LSD Acutely Increase BDNF Blood Plasma Levels in Healthy Volunteers.,"Despite preclinical evidence for psychedelic-induced neuroplasticity, confirmation in humans is grossly lacking. Given the increased interest in using low doses of psychedelics for psychiatric indications and the importance of neuroplasticity in the therapeutic response, this placebo-controlled within-subject study investigated the effect of single low doses of LSD (5, 10, and 20 μg) on circulating BDNF levels in healthy volunteers. Blood samples were collected every 2 h over 6 h, and BDNF levels were determined afterward in blood plasma using ELISA. The findings demonstrated an increase in BDNF blood plasma levels at 4 h (5 μg) and 6 h (5 and 20 μg) compared to that for the placebo. The finding that LSD acutely increases BDNF levels warrants studies in patient populations.",2021,The findings demonstrated an increase in BDNF blood plasma levels at 4 h (5 μg) and 6 h (5 and 20 μg) compared to that for the placebo.,"['healthy volunteers', 'Healthy Volunteers']","['LSD', 'placebo']","['circulating BDNF levels', 'BDNF levels', 'BDNF Blood Plasma Levels', 'BDNF blood plasma levels']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0024334', 'cui_str': 'Lysergic acid diethylamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",,0.0344114,The findings demonstrated an increase in BDNF blood plasma levels at 4 h (5 μg) and 6 h (5 and 20 μg) compared to that for the placebo.,"[{'ForeName': 'Nadia R P W', 'Initials': 'NRPW', 'LastName': 'Hutten', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, Maastricht 6200 MD, The Netherlands.'}, {'ForeName': 'Natasha L', 'Initials': 'NL', 'LastName': 'Mason', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, Maastricht 6200 MD, The Netherlands.'}, {'ForeName': 'Patrick C', 'Initials': 'PC', 'LastName': 'Dolder', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, Maastricht 6200 MD, The Netherlands.'}, {'ForeName': 'Eef L', 'Initials': 'EL', 'LastName': 'Theunissen', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, Maastricht 6200 MD, The Netherlands.'}, {'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Holze', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel 4003, Switzerland.'}, {'ForeName': 'Matthias E', 'Initials': 'ME', 'LastName': 'Liechti', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel 4003, Switzerland.'}, {'ForeName': 'Nimmy', 'Initials': 'N', 'LastName': 'Varghese', 'Affiliation': 'Transfaculty Research Platform Molecular and Cognitive Neuroscience, University of Basel, Basel 4003, Switzerland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Eckert', 'Affiliation': 'Transfaculty Research Platform Molecular and Cognitive Neuroscience, University of Basel, Basel 4003, Switzerland.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Feilding', 'Affiliation': 'The Beckley Foundation, Beckley Park, Oxford OX3 9SY, United Kingdom.'}, {'ForeName': 'Johannes G', 'Initials': 'JG', 'LastName': 'Ramaekers', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, Maastricht 6200 MD, The Netherlands.'}, {'ForeName': 'Kim P C', 'Initials': 'KPC', 'LastName': 'Kuypers', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, Maastricht 6200 MD, The Netherlands.'}]",ACS pharmacology & translational science,['10.1021/acsptsci.0c00099'] 4019,33860116,Effects of Resmetirom on Noninvasive Endpoints in a 36-Week Phase 2 Active Treatment Extension Study in Patients With NASH.,"Resmetirom (MGL-3196), a selective thyroid hormone receptor-β agonist, was evaluated in a 36-week paired liver biopsy study (NCT02912260) in adults with biopsy-confirmed nonalcoholic steatohepatitis (NASH). The primary endpoint was relative liver fat reduction as assessed by MRI-proton density fat fraction (MRI-PDFF), and secondary endpoints included histopathology. Subsequently, a 36-week active treatment open-label extension (OLE) study was conducted in 31 consenting patients (including 14 former placebo patients) with persistently mild to markedly elevated liver enzymes at the end of the main study. In patients treated with resmetirom (80 or 100 mg orally per day), MRI-PDFF reduction at OLE week 36 was -11.1% (1.5%) mean reduction (standard error [SE]; P  < 0.0001) and -52.3% (4.4%) mean relative reduction, P  < 0.0001. Low-density lipoprotein (LDL) cholesterol (-26.1% [4.5%], P  < 0.0001), apolipoprotein B (-23.8% [3.0%], P  < 0.0001), and triglycerides (-19.6% [5.4%], P  = 0.0012; -46.1 [14.5] mg/dL, P  = 0.0031) were reduced from baseline. Markers of fibrosis were reduced, including liver stiffness assessed by transient elastography (-2.1 [0.8] mean kilopascals [SE], P  = 0.015) and N-terminal type III collagen pro-peptide (PRO-C3) (-9.8 [2.3] ng/mL, P  = 0.0004 (baseline ≥ 10 ng/mL). In the main and OLE studies, PRO-C3/C3M (matrix metalloproteinase-degraded C3), a marker of net fibrosis formation, was reduced in resmetirom-treated patients (-0.76 [-1.27, -0.24], P  = 0.0044 and -0.68, P  < 0.0001, respectively). Resmetirom was well tolerated, with few, nonserious adverse events. Conclusion: The results of this 36-week OLE study support the efficacy and safety of resmetirom at daily doses of 80 mg and 100 mg, used in the ongoing phase 3 NASH study, MAESTRO-NASH (NCT03900429). The OLE study demonstrates a potential for noninvasive assessments to monitor the response to resmetirom from an individual patient with NASH.",2021,"Low-density lipoprotein (LDL) cholesterol (-26.1% [4.5%], P  ","['10', '31 consenting patients (including 14 former placebo patients) with persistently mild to markedly elevated liver enzymes at the end of the main study', 'adults with biopsy-confirmed nonalcoholic steatohepatitis (NASH', 'Patients With NASH']",['Resmetirom'],"['MRI-PDFF reduction', 'mean reduction (standard error [SE]; P', 'liver stiffness assessed by transient elastography', 'efficacy and safety', 'Low-density lipoprotein (LDL) cholesterol', 'Markers of fibrosis', 'apolipoprotein B', 'triglycerides', 'relative liver fat reduction as assessed by MRI-proton density fat fraction (MRI-PDFF), and secondary endpoints included histopathology']","[{'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0235996', 'cui_str': 'Hepatic enzyme increased'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}]",[],"[{'cui': 'C4761214', 'cui_str': 'Magnetic resonance proton density fat fraction measurement'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C2748260', 'cui_str': 'Transient elastography'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0243140', 'cui_str': 'histopathology'}]",31.0,0.0900047,"Low-density lipoprotein (LDL) cholesterol (-26.1% [4.5%], P  ","[{'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Harrison', 'Affiliation': 'Radcliffe Department of Medicine University of Oxford Oxford United Kingdom.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Bashir', 'Affiliation': 'Department of Radiology Center for Advanced Magnetic Resonance Duke University Medical Center Durham NC USA.'}, {'ForeName': 'Sam E', 'Initials': 'SE', 'LastName': 'Moussa', 'Affiliation': 'Department of Medicine University of Arizona for Medical Sciences Tuscon AZ USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'McCarty', 'Affiliation': 'Medpace Cincinnati OH USA.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Pablo Frias', 'Affiliation': 'Department of Medicine University of California San Diego CA USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Taub', 'Affiliation': 'Madrigal Pharmaceuticals West Conshohocken PA USA.'}, {'ForeName': 'Naim', 'Initials': 'N', 'LastName': 'Alkhouri', 'Affiliation': 'Arizona Liver Health Phoenix AZ USA.'}]",Hepatology communications,['10.1002/hep4.1657'] 4020,33860029,"Proximate Composition, Antinutritional Content, Microbial Load, and Sensory Acceptability of Noodles Formulated from Moringa ( Moringa oleifera ) Leaf Powder and Wheat Flour Blend.","Background Noodle products are popular throughout the world, and they can be prepared from cereal like wheat, maize, and rice. Nowadays, healthy and nutritious product requirement has been increasing. Thus, research on the nutrition-rich but neglected crop is becoming visible nowadays to ensure global food security and to satisfy the nutritional need. Research indicated that moringa tree leaf powder has good nutritional value, but it is not yet customized and properly consumed. Method The study is aimed at developing noodles from wheat flour and moringa leaf powder and evaluating proximate composition, antinutritional content (phytate and tannin), microbial load (total plate count and yeast and mold count), and sensory acceptability. The experiment contains four treatments and one control. The data from proximate composition, antinutritional content, microbial load, and sensory acceptability were subjected to SAS version 9 software. A complete randomized design was used to analyze the proximate composition, antinutritional content, and microbial load data, and a randomized complete block design was used to analyze the acceptability test. Result The study revealed that in the noodles formulated from 80% durum wheat flour and 20% of moringa leaf powder, the ash, protein, fat, fiber, gross energy, phytate, and tannin content were increased by 39.39%, 10.86%, 153%, 42.2%, 3.43%, 39.83%, and 329.78%, respectively, as compared with noodles made from 100% durum wheat flour. However, moisture, total bacteria count, and yeast and mold count were decreased by 28.71%, 45.52%, and 55.93%, respectively. Similarly, the study also revealed that the acceptability test of noodles was decreased as moringa leaf powder concentration is increased. Conclusion In conclusion, besides the good nutritional profile and antimicrobial capacity, moringa has antinutritional content and influences the sensory acceptability of products. Therefore, limiting the moringa leaf powder concentration is needed during the development of products using moringa leaf powder.",2021,"However, moisture, total bacteria count, and yeast and mold count were decreased by 28.71%, 45.52%, and 55.93%, respectively.",[],['Leaf Powder and Wheat Flour Blend'],"['antinutritional content, microbial load, and sensory acceptability', 'moringa leaf powder concentration', 'proximate composition, antinutritional content (phytate and tannin), microbial load (total plate count and yeast and mold count), and sensory acceptability', 'Proximate Composition, Antinutritional Content, Microbial Load, and Sensory Acceptability of Noodles Formulated from Moringa ( Moringa oleifera ', 'acceptability test of noodles', 'moisture, total bacteria count, and yeast and mold count', 'ash, protein, fat, fiber, gross energy, phytate, and tannin content']",[],"[{'cui': 'C0242724', 'cui_str': 'Leaves'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0458980', 'cui_str': 'Wheat flour'}]","[{'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0969724', 'cui_str': 'Moringa'}, {'cui': 'C0242724', 'cui_str': 'Leaves'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0086808', 'cui_str': 'Phytate'}, {'cui': 'C0039294', 'cui_str': 'Tannic Acid'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0036025', 'cui_str': 'Saccharomyces cerevisiae'}, {'cui': 'C0369241', 'cui_str': 'Filamentous fungus'}, {'cui': 'C0452689', 'cui_str': 'Noodles'}, {'cui': 'C0949952', 'cui_str': 'Drumsticktree'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0994524', 'cui_str': 'Ash'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0439806', 'cui_str': 'Gross'}]",,0.0786124,"However, moisture, total bacteria count, and yeast and mold count were decreased by 28.71%, 45.52%, and 55.93%, respectively.","[{'ForeName': 'Aemiro Tadesse', 'Initials': 'AT', 'LastName': 'Zula', 'Affiliation': 'School of Nutrition, Food Science and Technology Academic Center of Excellence in Human Nutrition, Hawassa University, Ethiopia.'}, {'ForeName': 'Dagem Alemayehu', 'Initials': 'DA', 'LastName': 'Ayele', 'Affiliation': 'School of Nutrition, Food Science and Technology Academic Center of Excellence in Human Nutrition, Hawassa University, Ethiopia.'}, {'ForeName': 'Woinshet Abera', 'Initials': 'WA', 'LastName': 'Egigayhu', 'Affiliation': 'Center of Food Science and Nutrition, Addis Ababa University, Ethiopia.'}]",International journal of food science,['10.1155/2021/6689247'] 4021,33859991,Withholding vs. Continuing Angiotensin-Converting Enzyme Inhibitors or Angiotensin Receptor Blockers Before Non-cardiac Surgery in Older Patients: Study Protocol for a Multicenter Randomized Controlled Trial.,"Background: Older hypertensive adults are at increased risk for postoperative morbidity and mortality. As first line antihypertensive drug therapy, angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) have many beneficial effects. However, the use of ACEIs/ARBs in the perioperative period remains controversial. This study aims to determine the effects of withholding vs. continuing ACEIs/ARBs before non-cardiac surgery on perioperative hypotension and postoperative outcomes in older patients. Methods: In this multicenter, randomized, double-blind, placebo-controlled trial, a total of 2036 patients aged 60-80 years undergoing non-cardiac surgical procedures will be randomly assigned, in a 1:1 ratio, to receive oral ACEIs/ARBs (the ACEIs/ARBs continued group) or inactive placebos (the ACEIs/ARBs withheld group) on the morning of surgery. For both groups, the ACEIs/ARBs will be continued from the first postoperative day. The primary outcome measure is the incidence of perioperative hypotensive events, defined as mean blood pressure (MBP) < 65 mmHg or ≥30% reduction in MBP from baseline during surgery and in a post-anesthesia care unit. The secondary outcomes include duration of perioperative hypotension, intraoperative use of fluids and vasopressors, hypotensive events within postoperative 3 days, and perioperative neurocognitive disorders, major adverse cardiocerebral events (a composite outcome of stroke, coma, myocardial infarction, heart block, and cardiac arrest), and mortality within 30 days after surgery. Discussion: The results of this trial will offer an evidence-based perioperative ACEIs/ARBs therapy for older hypertensive adults undergoing non-cardiac surgery. Study Registration: This study is approved by the Medical Ethics Committee of The First Affiliated Hospital of Soochow University (Approval No. 2020-077-1) and by the institutional ethics review board of each participating center. This protocol is registered at the Chinese Clinical Trials Registry (ChiCTR2000039376).",2021,"The secondary outcomes include duration of perioperative hypotension, intraoperative use of fluids and vasopressors, hypotensive events within postoperative 3 days, and perioperative neurocognitive disorders, major adverse cardiocerebral events (a composite outcome of stroke, coma, myocardial infarction, heart block, and cardiac arrest), and mortality within 30 days after surgery. ","['2036 patients aged 60-80 years undergoing non-cardiac surgical procedures', 'Medical Ethics Committee of The First Affiliated Hospital of Soochow University', 'Older Patients', 'Older hypertensive adults', 'older hypertensive adults undergoing non-cardiac surgery', 'older patients']","['oral ACEIs/ARBs (the ACEIs/ARBs continued group) or inactive placebos (the ACEIs/ARBs withheld group) on the morning of surgery', 'angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs', 'Angiotensin-Converting Enzyme Inhibitors or Angiotensin Receptor Blockers', 'placebo', 'withholding vs. continuing ACEIs/ARBs before non-cardiac surgery']","['incidence of perioperative hypotensive events, defined as mean blood pressure (MBP', 'duration of perioperative hypotension, intraoperative use of fluids and vasopressors, hypotensive events within postoperative 3 days, and perioperative neurocognitive disorders, major adverse cardiocerebral events (a composite outcome of stroke, coma, myocardial infarction, heart block, and cardiac arrest), and mortality within 30 days after surgery', 'postoperative morbidity and mortality', 'perioperative hypotension and postoperative outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0015004', 'cui_str': 'Medical Ethics'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0014063', 'cui_str': 'Myelin basic protein'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4041080', 'cui_str': 'Neurocognitive disorder'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0018794', 'cui_str': 'Heart block'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",2036.0,0.554858,"The secondary outcomes include duration of perioperative hypotension, intraoperative use of fluids and vasopressors, hypotensive events within postoperative 3 days, and perioperative neurocognitive disorders, major adverse cardiocerebral events (a composite outcome of stroke, coma, myocardial infarction, heart block, and cardiac arrest), and mortality within 30 days after surgery. ","[{'ForeName': 'Yu-Fan', 'Initials': 'YF', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Ya-Juan', 'Initials': 'YJ', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Yu-Qin', 'Initials': 'YQ', 'LastName': 'Long', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Hua-Yue', 'Initials': 'HY', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Xi-Sheng', 'Initials': 'XS', 'LastName': 'Shan', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Xiao-Mei', 'Initials': 'XM', 'LastName': 'Feng', 'Affiliation': 'Department of Anesthesiology, University of Utah Health, Salt Lake City, UT, United States.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Peng', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Fu-Hai', 'Initials': 'FH', 'LastName': 'Ji', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Soochow University, Suzhou, China.'}]",Frontiers in medicine,['10.3389/fmed.2021.654700'] 4022,32629079,A Multi-atlas Approach for Active Bone Marrow Sparing Radiation Therapy: Implementation in the NRG-GY006 Trial.,"PURPOSE Sparing active bone marrow (ABM) can reduce acute hematologic toxicity in patients undergoing chemoradiotherapy for cervical cancer, but ABM segmentation based on positron emission tomography/computed tomography (PET/CT) is costly. We sought to develop an atlas-based ABM segmentation method for implementation in a prospective clinical trial. METHODS AND MATERIALS A multiatlas was built on a training set of 144 patients and validated in 32 patients from the NRG-GY006 clinical trial. ABM for individual patients was defined as the subvolume of pelvic bone greater than the individual mean standardized uptake value on registered 18 F-fluorodeoxyglucose PET/CT images. Atlas-based and custom ABM segmentations were compared using the Dice similarity coefficient and mean distance to agreement and used to generate ABM-sparing intensity modulated radiation therapy plans. Dose-volume metrics and normal tissue complication probabilities of the two approaches were compared using linear regression. RESULTS Atlas-based ABM volumes (mean [standard deviation], 548.4 [88.3] cm 3 ) were slightly larger than custom ABM volumes (535.1 [93.2] cm 3 ), with a Dice similarity coefficient of 0.73. Total pelvic bone marrow V 20 and D mean were systematically higher and custom ABM V 10 was systematically lower with custom-based plans (slope: 1.021 [95% confidence interval (CI), 1.005-1.037], 1.014 [95% CI, 1.006-1.022], and 0.98 [95% CI, 0.97-0.99], respectively). We found no significant differences between atlas-based and custom-based plans in bowel, rectum, bladder, femoral heads, or target dose-volume metrics. CONCLUSIONS Atlas-based ABM segmentation can reduce pelvic bone marrow dose while achieving comparable target and other normal tissue dosimetry. This approach may allow ABM sparing in settings where PET/CT is unavailable.",2020,"We found no significant differences between atlas-based and custom-based plans in bowel, rectum, bladder, femoral heads, or target dose-volume metrics. ","['patients undergoing chemoradiotherapy for cervical cancer', '144 patients and validated in 32 patients from the NRG-GY006 clinical trial']","['Atlas-based ABM segmentation', 'Sparing active bone marrow (ABM']","['Total pelvic bone marrow', 'custom ABM volumes', 'normal tissue complication probabilities', 'acute hematologic toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030786', 'cui_str': 'Hip Bone'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",32.0,0.0858072,"We found no significant differences between atlas-based and custom-based plans in bowel, rectum, bladder, femoral heads, or target dose-volume metrics. ","[{'ForeName': 'Tahir', 'Initials': 'T', 'LastName': 'Yusufaly', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Austin', 'Initials': 'A', 'LastName': 'Miller', 'Affiliation': 'NRG Oncology, Statistics and Data Management Center, Roswell Park Cancer Institute, Buffalo, New York.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Medina-Palomo', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Casey W', 'Initials': 'CW', 'LastName': 'Williamson', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Nguyen', 'Affiliation': 'IROC Houston QA Center, MD Anderson, Houston, Texas.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Lowenstein', 'Affiliation': 'IROC Houston QA Center, MD Anderson, Houston, Texas.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Leath', 'Affiliation': 'Department of Gynecologic Oncology, University of Alabama Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': 'Department of Medical Physics, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Moore', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Moxley', 'Affiliation': 'Stephenson Cancer Center, University of Oklahoma, Oklahoma City, Oklahoma.'}, {'ForeName': 'Carlos M', 'Initials': 'CM', 'LastName': 'Chevere-Mourino', 'Affiliation': 'Radiation Oncology Center, Comprehensive Cancer Center, University of Puerto Rico, San Juan, Puerto Rico.'}, {'ForeName': 'Tony Y', 'Initials': 'TY', 'LastName': 'Eng', 'Affiliation': 'Department of Radiation Oncology, Winship Cancer Institute of Emory University, Atlanta, Georgia.'}, {'ForeName': 'Tarrick', 'Initials': 'T', 'LastName': 'Zaid', 'Affiliation': 'TA Methodist Hospital System, Houston Methodist Hospital, Houston, Texas.'}, {'ForeName': 'Loren K', 'Initials': 'LK', 'LastName': 'Mell', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California. Electronic address: lmell@health.ucsd.edu.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.06.071'] 4023,31607191,Examining the effect of mindfulness-based art therapy (MBAT) on stress and lifestyle of Iranian pregnant women.,"The purpose of this study was to determine the effect of mindfulness-based art therapy (MBAT) in decreasing stress and improving on pregnant women's life style in Neyshabur, Iran 2018. The participants of the present quasi-experimental study were 84 pregnant women. The findings showed that the MBAT group demonstrated a significant decrease in symptoms of distress and significant improvements in key aspects of the health-related style of life as measured by Health Promoting Lifestyle Profile-II questionnaire. Moreover, it was found that the MBAT intervention had a significant effect on improving lifestyle behaviours ( p  < .05). The highest mean score of lifestyle was for the sub-domain of nutrition (31.35 ± 5.34), while the lowest score was achieved by the sub-domains of physical activity (13.55 ± 1.89).The mean (SD) score of stress management was (19.12 ± 1.54). This investigation of MBAT provides initial encouraging data that support a possible future role for the intervention as a psychosocial option for decreasing symptoms of distress in pregnant women and improving their lifestyle.Impact statement What is already known on this subject? Mindfulness-based art therapy is a blend of basic meditation principles and art therapy. The results of this study showed that mindfulness-based art therapy (MBAT) could decrease the stress and improve lifestyle behaviours in pregnant women. What do the results of this study add? The results of the present study showed that mindfulness-based art therapy (MBAT) during pregnancy decreased the stress and improved life style. It is believed that changing lifestyle to include mind-body medicine such as MBAT in pregnant women will greatly reduce stress responses, and help protect pregnant women from disease during pregnancy. What are the implications of these findings for clinical practice and/or further research? The study showed the important role of mindfulness-based art therapy (MBAT) during pregnancy in reducing stress and improving life style.",2020,"Moreover, it was found that the MBAT intervention had a significant effect on improving lifestyle behaviours ( p  < .05).","[""pregnant women's life style in Neyshabur, Iran 2018"", 'pregnant women from disease during pregnancy', 'Iranian pregnant women', '84 pregnant women', 'pregnant women']","['Mindfulness-based art therapy', 'MBAT', 'mindfulness-based art therapy (MBAT', 'MBAT intervention']","['stress and improving life style', 'stress and improved life style', 'lifestyle behaviours', 'symptoms of distress', 'health-related style of life as measured by Health Promoting Lifestyle Profile-II questionnaire']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0003827', 'cui_str': 'Art therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",84.0,0.0208515,"Moreover, it was found that the MBAT intervention had a significant effect on improving lifestyle behaviours ( p  < .05).","[{'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Jalambadani', 'Affiliation': 'Department of Public Health, Neyshabur University of Medical Sciences, Neyshabur, Iran.'}, {'ForeName': 'Abasalt', 'Initials': 'A', 'LastName': 'Borji', 'Affiliation': 'Department of Basic Medical Sciences, Neyshabur University of Medical Sciences, Neyshabur, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Bakaeian', 'Affiliation': 'Department of Nursing, Neyshabur University of Medical Sciences, Neyshabur, Iran.'}]",Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology,['10.1080/01443615.2019.1652889'] 4024,31972253,The functional implications and modifiability of resting-state brain network complexity in older adults.,"The dynamics of the resting-state activity in brain functional networks are complex, containing meaningful patterns over multiple temporal scales. Such physiologic complexity is often diminished in older adults. Here we aim to examine if the resting-state complexity within functional brain networks is sensitive to functional status in older adults and if repeated exposure to transcranial direct current stimulation (tDCS) would modulate such complexity. Twelve older adults with slow gait and mild-to-moderate executive dysfunction and 12 age- and sex-matched controls completed a baseline resting-state fMRI (rs-fMRI). Ten participants in the functionally-limited group then completed ten 20-minute sessions of real (n = 6) or sham (n = 4) tDCS targeting the left prefrontal cortex over a two-week period as well as a follow-up rs-fMRI. The resting-state complexity associated with seven functional networks was quantified by averaging the multiscale entropy (MSE) of the blood oxygen level-dependent (BOLD) time-series for all voxels within each network. Compared to controls, functionally-limited group exhibited lower complexity in the motor, ventral attention, limbic, executive and default mode networks (F > 6.3, p < 0.02). Within this group, those who received tDCS exhibited greater complexity within the ventral, executive and limbic networks (p < 0.04) post intervention as compared to baseline, while no significant changes in sham group was observed. This study provides preliminary evidence that older adults with functional limitations had diminished complexity of resting-state brain network activity and repeated exposure to tDCS may increase that resting-state complexity, warranting future studies to establish such complexity as a marker of brain health in older adults.",2020,"Compared to controls, functionally-limited group exhibited lower complexity in the motor, ventral attention, limbic, executive and default mode networks (F > 6.3, p < 0.02).","['older adults with functional limitations', 'older adults', 'Twelve older adults with slow gait and mild-to-moderate executive dysfunction and 12 age- and sex-matched controls completed a baseline resting-state fMRI (rs-fMRI']","['tDCS', 'transcranial direct current stimulation (tDCS', 'sham (n\u2009=\u20094) tDCS']","['complexity within the ventral, executive and limbic networks', 'motor, ventral attention, limbic, executive and default mode networks', 'blood oxygen level-dependent (BOLD) time-series']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C2748208', 'cui_str': 'Executive dysfunction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205549', 'cui_str': 'Series'}]",12.0,0.0624963,"Compared to controls, functionally-limited group exhibited lower complexity in the motor, ventral attention, limbic, executive and default mode networks (F > 6.3, p < 0.02).","[{'ForeName': 'Junhong', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, Boston, MA, United States; Harvard Medical School, Boston, MA, United States; Division of Gerontology, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States. Electronic address: junhongzhou@hsl.harvard.edu.'}, {'ForeName': 'On-Yee', 'Initials': 'OY', 'LastName': 'Lo', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, Boston, MA, United States; Harvard Medical School, Boston, MA, United States; Division of Gerontology, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Halko', 'Affiliation': 'Harvard Medical School, Boston, MA, United States; Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States; Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Harrison', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, Boston, MA, United States.'}, {'ForeName': 'Lewis A', 'Initials': 'LA', 'LastName': 'Lipsitz', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, Boston, MA, United States; Harvard Medical School, Boston, MA, United States; Division of Gerontology, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Manor', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, Boston, MA, United States; Harvard Medical School, Boston, MA, United States; Division of Gerontology, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.'}]",Neuroscience letters,['10.1016/j.neulet.2020.134775'] 4025,33205809,"Ciraparantag, an anticoagulant reversal drug: mechanism of action, pharmacokinetics, and reversal of anticoagulants.","Ciraparantag, an anticoagulant reversal agent, is a small molecule specifically designed to bind noncovalently by charge-charge interaction to unfractionated heparin and low-molecular-weight heparin. It shows binding characteristics that are similar to those of direct oral anticoagulants (DOACs). A dynamic light-scattering methodology was used to demonstrate ciraparantag's binding to the heparins and DOACs and its lack of binding to a variety of proteins including coagulation factors and commonly used drugs. Ciraparantag reaches maximum concentration within minutes after IV administration with a half-life of 12 to 19 minutes. It is primarily hydrolyzed by serum peptidases into 2 metabolites, neither of which has substantial activity. Ciraparantag and its metabolites are recovered almost entirely in the urine. In animal models of bleeding (rat tail transection and liver laceration), a single IV dose of ciraparantag given at peak concentrations of the anticoagulant, but before the bleeding injury, significantly reduced the blood loss. Ciraparantag, given after the bleeding injury, also significantly reduced blood loss. It appears to have substantial ability to reduce blood loss in animal models in which a variety of anticoagulants are used and has potential as a useful DOAC reversal agent.",2021,"Ciraparantag, given after the bleeding injury, also significantly reduced blood loss.",[],[],"['blood loss', 'bleeding (rat tail transection and liver laceration']",[],[],"[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0039259', 'cui_str': 'Tail'}, {'cui': 'C0152060', 'cui_str': 'Transection'}, {'cui': 'C0347633', 'cui_str': 'Laceration of liver'}]",,0.0227604,"Ciraparantag, given after the bleeding injury, also significantly reduced blood loss.","[{'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Ansell', 'Affiliation': 'Hofstra Northwell School of Medicine, Hempstead, NY.'}, {'ForeName': 'Bryan E', 'Initials': 'BE', 'LastName': 'Laulicht', 'Affiliation': 'Landsdowne Laboratories Inc, Fairfield, CT.'}, {'ForeName': 'Sasha H', 'Initials': 'SH', 'LastName': 'Bakhru', 'Affiliation': 'Perosphere Technologies Inc, Danbury, CT.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Burnett', 'Affiliation': 'University of New Mexico Health Sciences Center, Albuquerque, NM.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Perosphere Technologies Inc, Danbury, CT.'}, {'ForeName': 'Lirong', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Perosphere Technologies Inc, Danbury, CT.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Baker', 'Affiliation': 'Amgen, Warwick, RI; and.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Villano', 'Affiliation': 'AMAG Pharmaceuticals Inc, Waltham, MA.'}, {'ForeName': 'Solomon', 'Initials': 'S', 'LastName': 'Steiner', 'Affiliation': 'Perosphere Technologies Inc, Danbury, CT.'}]",Blood,['10.1182/blood.2020007116'] 4026,33864634,Clinical Features of Essential Voice Tremor and Associations with Tremor Severity and Response to Octanoic Acid Treatment.,"OBJECTIVES/HYPOTHESIS The purpose of this study was to characterize the clinical features, tremor variability, and factors related to octanoic acid (OA) treatment response in essential voice tremor (EVT). STUDY DESIGN Prospective, double blind, placebo-controlled, crossover study with secondary analysis. METHODS Clinical tremor features in 16 individuals with EVT were comprehensively assessed, and correlations with acoustic tremor severity were determined. Intrasubject and intersubject variability measures were analyzed from 18 repeated measures for each acoustic tremor variable. Clinical correlates of treatment response were evaluated, and cumulative effects over a 2-week period of OA drug dosing were assessed. RESULTS Participants with EVT were 90% female with a mean age of 70.31 (±8.68) years at the time of testing. Neurologist-rated body tremor beyond the vocal tract region was present in 69% of participants, and multiple vocal tract regions contributed to the voice tremor. The mean frequency of amplitude tremor was 4.67 Hz (±0.88). Respiratory tremor was evident in 50% of participants. Participants experienced moderate voice-related disability as assessed on the Voice Handicap Index-10 (19.38, ±8.50), and increased speaking effort. Acoustic tremor severity was significantly associated with severity of tremor affecting vocal tract structures. Overall intrasubject consistency was strong (single measures intraclass correlation coefficient = 0.701, P < .01), with high intersubject variability. Acoustic tremor severity was significantly, positively associated with treatment response, and results suggested a cumulative OA benefit for magnitude of amplitude tremor. CONCLUSIONS This study identified common clinical correlates of EVT and demonstrated positive associations between acoustic tremor severity, severity of affected vocal tract structures, and response to treatment. LEVEL OF EVIDENCE 2 Laryngoscope, 2021.",2021,"Acoustic tremor severity was significantly, positively associated with treatment response, and results suggested a cumulative OA benefit for magnitude of amplitude tremor. ","['Participants with EVT were 90% female with a mean age of 70.31 (±8.68) years at the time of testing', '16 individuals with EVT']",['placebo'],"['moderate voice-related disability', 'Respiratory tremor', 'Acoustic tremor severity', 'mean frequency of amplitude tremor', 'Voice Handicap Index-10']","[{'cui': 'C0234809', 'cui_str': 'Organic voice tremor'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C2985106', 'cui_str': 'Voice handicap index'}]",16.0,0.0393706,"Acoustic tremor severity was significantly, positively associated with treatment response, and results suggested a cumulative OA benefit for magnitude of amplitude tremor. ","[{'ForeName': 'Soren Y', 'Initials': 'SY', 'LastName': 'Lowell', 'Affiliation': 'Department of Communication Sciences and Disorders, Syracuse University, Syracuse, New York, U.S.A.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Kelley', 'Affiliation': 'Department of Otolaryngology and Communication Sciences, SUNY Upstate Medical University, Syracuse, New York, U.S.A.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Dischinat', 'Affiliation': 'Department of Communication Sciences and Disorders, Syracuse University, Syracuse, New York, U.S.A.'}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Monahan', 'Affiliation': 'Department of Communication Sciences and Disorders, Syracuse University, Syracuse, New York, U.S.A.'}, {'ForeName': 'Carly J', 'Initials': 'CJ', 'LastName': 'Hosbach-Cannon', 'Affiliation': 'Department of Communication Sciences and Disorders, Syracuse University, Syracuse, New York, U.S.A.'}, {'ForeName': 'Raymond H', 'Initials': 'RH', 'LastName': 'Colton', 'Affiliation': 'Department of Communication Sciences and Disorders, Syracuse University, Syracuse, New York, U.S.A.'}, {'ForeName': 'Dragos', 'Initials': 'D', 'LastName': 'Mihaila', 'Affiliation': 'Department of Neurology, SUNY Upstate Medical University, Syracuse, New York, U.S.A.'}]",The Laryngoscope,['10.1002/lary.29558'] 4027,33864623,Low absolute lymphocyte count is a poor prognostic factor for untreated advanced follicular lymphoma treated with rituximab plus bendamustine: results of the prospective phase 2 CONVERT trial.,"The aim of this trial is to evaluate the utility of rituximab-bendamustine (R-B) for untreated advanced follicular lymphoma (FL) showing non-optimal response (nOR) to R-CHOP, and to identify clinical prognostic factors for FL patients receiving R-B. Patients who failed to achieve complete response/complete response unconfirmed (CR/CRu) [nOR-group] after 2 cycles of R-CHOP subsequently received 6 cycles of R-B. The primary endpoint was the 3-year progression-free survival (PFS) rate. Secondary endpoints included determination of prognostic factors. Fifty-six patients initially received R-CHOP, 43/56 patients (76.8%) were judged as nOR, and 33/43 patients (76.7%) completed 6 cycles of R-B. At a median follow-up of 50.6 months in the nOR-group, the 3-year PFS rate was 69.0%, and the 3-year overall survival (OS) rate was 92.7%. The most common toxicities associated with R-B were grade 3-4 lymphopenia (93.0%) and neutropenia (74.4%), both of which were manageable. A multivariate analysis including dose intensity, serum soluble interleukin-2 receptor, and FL international prognostic index-2 revealed low absolute lymphocyte count (<  869/μL) at diagnosis was an independent poor prognostic factor for both PFS and OS in the R-B-treated nOR-group. This result was further confirmed in validation cohorts including R-B-treated de novo (n = 40) and relapsed (n = 49) FL patients.",2021,"A multivariate analysis including dose intensity, serum soluble interleukin-2 receptor, and FL international prognostic index-2 revealed low absolute lymphocyte count (<  869/μL) at diagnosis was an independent poor prognostic factor for both PFS and OS in the R-B-treated nOR-group.","['untreated advanced follicular lymphoma (FL', 'FL patients receiving R-B. Patients who failed to achieve complete response/complete response unconfirmed (CR/CRu) [nOR-group] after 2 cycles of R-CHOP subsequently received 6 cycles of R-B']","['rituximab plus bendamustine', 'rituximab-bendamustine (R-B']","['3-year overall survival (OS) rate', '3-year progression-free survival (PFS) rate', 'neutropenia', 'determination of prognostic factors', '3-year PFS rate']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0055598', 'cui_str': 'CHOP protocol'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C1514474', 'cui_str': 'Prognostic Factors'}]",56.0,0.0219781,"A multivariate analysis including dose intensity, serum soluble interleukin-2 receptor, and FL international prognostic index-2 revealed low absolute lymphocyte count (<  869/μL) at diagnosis was an independent poor prognostic factor for both PFS and OS in the R-B-treated nOR-group.","[{'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Rai', 'Affiliation': 'Department of Hematology and Rheumatology, Faculty of Medicine, Kindai University, 377-2, Ohno-higashi, Osaka-sayama, Osaka, 589-8511, Japan. rai@med.kindai.ac.jp.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Inoue', 'Affiliation': 'Department of Hematology and Rheumatology, Faculty of Medicine, Kindai University, 377-2, Ohno-higashi, Osaka-sayama, Osaka, 589-8511, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Hanamoto', 'Affiliation': 'Department of Hematology, Faculty of Medicine, Nara Hospital Kindai University, Ikoma, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Matsuda', 'Affiliation': 'Department of Hematology, PL General Hospital, Tondabayashi, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Maeda', 'Affiliation': 'Department of Hematology, Minami Sakai Hospital, Sakai, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Wada', 'Affiliation': 'Department of Hematology, Izumi City General Hospital, Izumi, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Haeno', 'Affiliation': 'Department of Hematology and Rheumatology, Faculty of Medicine, Kindai University, 377-2, Ohno-higashi, Osaka-sayama, Osaka, 589-8511, Japan.'}, {'ForeName': 'Yosaku', 'Initials': 'Y', 'LastName': 'Watatani', 'Affiliation': 'Department of Hematology and Rheumatology, Faculty of Medicine, Kindai University, 377-2, Ohno-higashi, Osaka-sayama, Osaka, 589-8511, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Kumode', 'Affiliation': 'Department of Hematology and Rheumatology, Faculty of Medicine, Kindai University, 377-2, Ohno-higashi, Osaka-sayama, Osaka, 589-8511, Japan.'}, {'ForeName': 'Chikara', 'Initials': 'C', 'LastName': 'Hirase', 'Affiliation': 'Department of Hematology and Rheumatology, Faculty of Medicine, Kindai University, 377-2, Ohno-higashi, Osaka-sayama, Osaka, 589-8511, Japan.'}, {'ForeName': 'J Luis', 'Initials': 'JL', 'LastName': 'Espinoza', 'Affiliation': 'Department of Hematology and Rheumatology, Faculty of Medicine, Kindai University, 377-2, Ohno-higashi, Osaka-sayama, Osaka, 589-8511, Japan.'}, {'ForeName': 'Yasuyoshi', 'Initials': 'Y', 'LastName': 'Morita', 'Affiliation': 'Department of Hematology and Rheumatology, Faculty of Medicine, Kindai University, 377-2, Ohno-higashi, Osaka-sayama, Osaka, 589-8511, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Department of Hematology and Rheumatology, Faculty of Medicine, Kindai University, 377-2, Ohno-higashi, Osaka-sayama, Osaka, 589-8511, Japan.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Tatsumi', 'Affiliation': 'Department of Hematology and Rheumatology, Faculty of Medicine, Kindai University, 377-2, Ohno-higashi, Osaka-sayama, Osaka, 589-8511, Japan.'}, {'ForeName': 'Itaru', 'Initials': 'I', 'LastName': 'Matsumura', 'Affiliation': 'Department of Hematology and Rheumatology, Faculty of Medicine, Kindai University, 377-2, Ohno-higashi, Osaka-sayama, Osaka, 589-8511, Japan.'}]",International journal of hematology,['10.1007/s12185-021-03148-0'] 4028,33841399,A Phase II Randomized Clinical Trial and Mechanistic Studies Using Improved Probiotics to Prevent Oral Mucositis Induced by Concurrent Radiotherapy and Chemotherapy in Nasopharyngeal Carcinoma.,"Earlier evidence has proven that probiotic supplements can reduce concurrent chemoradiotherapy (CCRT)-induced oral mucositis (OM) in nasopharyngeal cancer (NPC). The incidence of severe OM (grade 3 or higher) was the primary endpoint in this study. We first enrolled 85 patients with locally advanced NPC who were undergoing CCRT. Of them, 77 patients were finally selected and randomized (1:1) to receive either a probiotic cocktail or placebo. To investigate the protective effects and the mechanism of probiotic cocktail treatment on OM induced by radiotherapy and chemotherapy, we randomly divided the rats into the control (C) group, the model (M) group, and the probiotic (P) group. After treatment, samples from the tongue, blood, and fecal and proximal colon tissues on various days (7th, 14th, and 21st days) were collected and tested for the inflammatory response, cell apoptosis, intestinal permeability, and intestinal microbial changes. We found that patients taking the probiotic cocktail showed significantly lower OM. The values of the incidence of 0, 1, 2, 3, and 4 grades of OM in the placebo group and in the probiotic cocktail group were reported to be 0, 14.7, 38.2, 32.4, and 14.7% and 13.9, 36.1, 25, 22.2, and 2.8%, respectively. Furthermore, patients in the probiotic cocktail group showed a decrease in the reduction rate of CD3 + T cells (75.5% vs. 81%, p < 0.01), CD4 + T cells (64.53% vs. 79.53%, p < 0.01), and CD8 + T cells (75.59 vs. 62.36%, p < 0.01) compared to the placebo group. In the rat model, the probiotic cocktail could ameliorate the severity of OM, decrease the inflammatory response, cause cell apoptosis and intestinal permeability, and restore the structure of gut microbiota to normalcy. In conclusion, the modified probiotic cocktail significantly reduces the severity of OM by enhancing the immune response of patients with NPC and modifying the structure of gut microbiota. Clinical Trial Registration: The Clinical Trial Registration should be the NCT03112837.",2021,"The values of the incidence of 0, 1, 2, 3, and 4 grades of OM in the placebo group and in the probiotic cocktail group were reported to be 0, 14.7, 38.2, 32.4, and 14.7% and 13.9, 36.1, 25, 22.2, and 2.8%, respectively.","['85 patients with locally advanced NPC who were undergoing CCRT', '77 patients', 'nasopharyngeal cancer (NPC', 'Nasopharyngeal Carcinoma']","['probiotic cocktail', 'Radiotherapy and Chemotherapy', 'placebo', 'radiotherapy and chemotherapy', 'probiotic cocktail or placebo']","['CD8 + T cells', 'inflammatory response, cell apoptosis, intestinal permeability, and intestinal microbial changes', 'severity of OM', 'inflammatory response, cause cell apoptosis and intestinal permeability', 'CD4 + T cells', 'reduction rate of CD3 + T cells', 'OM', 'incidence of severe OM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0153392', 'cui_str': 'Malignant tumor of nasopharynx'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0678420', 'cui_str': 'Cocktail'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",85.0,0.101716,"The values of the incidence of 0, 1, 2, 3, and 4 grades of OM in the placebo group and in the probiotic cocktail group were reported to be 0, 14.7, 38.2, 32.4, and 14.7% and 13.9, 36.1, 25, 22.2, and 2.8%, respectively.","[{'ForeName': 'Chaofei', 'Initials': 'C', 'LastName': 'Xia', 'Affiliation': 'National Engineering Research Center for Bioengineering Drugs and Technologies, Institute of Translational Medicine, Nanchang University, Nanchang, China.'}, {'ForeName': 'Chunling', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'Department of Radiation Oncology, Jiangxi Cancer Hospital, Nanchang, China.'}, {'ForeName': 'Wenyu', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'National Engineering Research Center for Bioengineering Drugs and Technologies, Institute of Translational Medicine, Nanchang University, Nanchang, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'National Engineering Research Center for Bioengineering Drugs and Technologies, Institute of Translational Medicine, Nanchang University, Nanchang, China.'}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Hong', 'Affiliation': 'National Engineering Research Center for Bioengineering Drugs and Technologies, Institute of Translational Medicine, Nanchang University, Nanchang, China.'}, {'ForeName': 'Jingao', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Radiation Oncology, Jiangxi Cancer Hospital, Nanchang, China.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': 'Department of Radiation Oncology, Jiangxi Cancer Hospital, Nanchang, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wei', 'Affiliation': 'Precision Medicine Institute, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Xin', 'Affiliation': 'National Engineering Research Center for Bioengineering Drugs and Technologies, Institute of Translational Medicine, Nanchang University, Nanchang, China.'}, {'ForeName': 'Tingtao', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'National Engineering Research Center for Bioengineering Drugs and Technologies, Institute of Translational Medicine, Nanchang University, Nanchang, China.'}]",Frontiers in immunology,['10.3389/fimmu.2021.618150'] 4029,33841311,Amantadine ER (Gocovri ® ) Significantly Increases ON Time Without Any Dyskinesia: Pooled Analyses From Pivotal Trials in Parkinson's Disease.,"Background: Clinical trials for antiparkinsonian drugs aimed at managing motor complications typically use patient diaries to divide levodopa-induced dyskinesias (LID) into ""troublesome"" and ""non-troublesome"" categories. Yet, given the choice, most patients would prefer to live without experiencing any dyskinesia. However, the concept of evaluating time spent ON without any dyskinesia as an outcome has never been tested. We conducted analyses of pooled Gocovri pivotal trial data in order to evaluate the extent to which Gocovri increased the time PD patients spent ON without dyskinesia (troublesome or non-troublesome), beyond its already identified improvement in reducing troublesome dyskinesia. Methods: Patients enrolled in phase 3 trials (EASE LID [NCT02136914] or EASE LID 3 [NCT02274766]) recorded time spent in the following PD diary states at baseline and Week 12 (endpoint): asleep, OFF, ON with troublesome dyskinesia, ON with non-troublesome dyskinesia, and ON without dyskinesia. Mixed model repeated measures analyses with estimated Cohen D effect sizes were performed on the modified intent to treat population to evaluate changes in time spent in these states. Results: Patients randomized to receive Gocovri showed an increase in ON time without dyskinesia and corresponding decreases in ON time with dyskinesia and OFF time vs. placebo. Treatment effects were statistically significant for Gocovri vs. placebo starting at Week 2 and were sustained until Week 12. On MMRM analysis at Week 12, patients in the Gocovri group showed an adjusted mean ± SE increase over placebo of 2.9 ± 0.6 h in ON time without dyskinesia (Cohen D effect size 0.79) and an adjusted mean ± SE decrease of -1.9 ± 0.6 h in ON time with dyskinesia (troublesome + non-troublesome) (Cohen D effect size 0.49), that included a -1.5 ± 0.4 h placebo-adjusted reduction in ON time with troublesome dyskinesia and a -0.6 ± 0.4 h reduction in ON time with non-troublesome dyskinesia. OFF time was reduced by -1.0 ± 0.3 h compared to placebo. Conclusions: Gocovri treatment more than doubled the daily time patients spent ON without dyskinesia. These results suggest that the Gocovri treatment effect was driven by a reduction in overall motor complications including ON time with both troublesome and non-troublesome dyskinesia as well as time spent OFF.",2021,Results: Patients randomized to receive Gocovri showed an increase in ON time without dyskinesia and corresponding decreases in ON time with dyskinesia and OFF time vs. placebo.,"[""Parkinson's Disease""]","['placebo', 'Amantadine ER (Gocovri ® ']","['daily time patients spent ON without dyskinesia', 'OFF time', 'time spent in the following PD diary states at baseline and Week 12 (endpoint): asleep, OFF, ON with troublesome dyskinesia, ON with non-troublesome dyskinesia, and ON without dyskinesia', 'overall motor complications', 'Dyskinesia']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002403', 'cui_str': 'Amantadine'}, {'cui': 'C4522700', 'cui_str': 'Gocovri'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0424522', 'cui_str': 'Asleep'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.100277,Results: Patients randomized to receive Gocovri showed an increase in ON time without dyskinesia and corresponding decreases in ON time with dyskinesia and OFF time vs. placebo.,"[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Hauser', 'Affiliation': 'Department of Neurology, University of South Florida, Tampa, FL, United States.'}, {'ForeName': 'Ryan R', 'Initials': 'RR', 'LastName': 'Walsh', 'Affiliation': 'Muhammad Ali Parkinson Center at Barrow Neurological Institute, Phoenix, AZ, United States.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Pahwa', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, KS, United States.'}, {'ForeName': 'Dustin', 'Initials': 'D', 'LastName': 'Chernick', 'Affiliation': 'Adamas Pharmaceuticals, Inc., Emeryville, CA, United States.'}, {'ForeName': 'Andrea E', 'Initials': 'AE', 'LastName': 'Formella', 'Affiliation': 'Adamas Pharmaceuticals, Inc., Emeryville, CA, United States.'}]",Frontiers in neurology,['10.3389/fneur.2021.645706'] 4030,33841279,Path Learning in Individuals With Down Syndrome: The Challenge of Learning Condition and Cognitive Abilities.,"Analyzing navigational abilities and related aspects in individuals with Down syndrome (DS) is of considerable interest because of its relevance to everyday life. This study investigates path learning, the conditions favoring it, and the cognitive abilities involved. A group of 30 adults with DS and 32 typically-developing (TD) children matched on receptive vocabulary were shown a 4 × 4 Floor Matrix and asked to repeat increasingly long sequences of steps by walking on the grid. The sequences were presented under two learning conditions, one called Oral instructions (participants received verbal instructions such as ""turn right"" or ""turn left""), the other Observation (participants watched the experimenter's moves). Participants were also assessed on verbal and visuospatial cognitive measures. The results showed a similarly better performance in both groups when the Floor Matrix task was administered in the Observation as opposed to the Oral instructions condition. As for the relation with cognitive abilities, in the Floor Matrix task in the Oral instructions condition, individuals with DS showed an effect of both verbal and visuospatial abilities, which was only positive for verbal ability. The effect of verbal and visuospatial abilities was negligible in the TD group. In the Observation condition, performance was predicted by sequential working memory in both groups. Overall, these results shed light on path learning in individuals with DS, showing that they benefited from the Observation condition, and that the involvement of their cognitive abilities depended on the learning condition.",2021,"As for the relation with cognitive abilities, in the Floor Matrix task in the Oral instructions condition, individuals with DS showed an effect of both verbal and visuospatial abilities, which was only positive for verbal ability.","['individuals with Down syndrome (DS', 'Individuals With Down Syndrome', '30 adults with DS and 32 typically-developing (TD) children matched on receptive vocabulary', 'individuals with DS']","['verbal instructions such as ""turn right"" or ""turn left']","['verbal and visuospatial cognitive measures', 'verbal and visuospatial abilities']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013080', 'cui_str': 'Trisomy 21'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0541749', 'cui_str': 'Does turn'}, {'cui': 'C0205090', 'cui_str': 'Right'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",30.0,0.0530586,"As for the relation with cognitive abilities, in the Floor Matrix task in the Oral instructions condition, individuals with DS showed an effect of both verbal and visuospatial abilities, which was only positive for verbal ability.","[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Meneghetti', 'Affiliation': 'Department of General Psychology, University of Padova, Padua, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Toffalini', 'Affiliation': 'Department of General Psychology, University of Padova, Padua, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Lanfranchi', 'Affiliation': 'Department of Developmental Psychology and Socialization, University of Padova, Padua, Italy.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Roch', 'Affiliation': 'Department of Developmental Psychology and Socialization, University of Padova, Padua, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Carretti', 'Affiliation': 'Department of General Psychology, University of Padova, Padua, Italy.'}]",Frontiers in psychology,['10.3389/fpsyg.2021.643702'] 4031,33841172,The Effects of a 10-Week Neuromuscular Training on Postural Control in Elite Youth Competitive Ballroom Dancers: A Randomized Controlled Trial.,"The purpose of this randomized controlled trial was to evaluate the efficacy of a 10-week neuromuscular training (NMT) program on the postural control of elite youth competitive ballroom dancers. Forty-two dancers (21 couples) were randomly assigned to either the NMT group ( n = 22) or the control group (CG; n = 20). Participants in NMT underwent a three-sessions-per-week NMT program for 10 weeks. Testing at baseline and after the 10 weeks intervention included the Y-balance test (YBT) and Modified-Balance Error Scoring System (M-BESS). Results of YBT indicated that NMT participants demonstrated increased reach in the posterolateral and posteromedial directions for the right and left lower limb, whereas no significant change was found in the anterior direction for both limbs. Results of Modified-Balance Error Scoring System (M-BESS) showed that NMT participants displayed significantly decreased errors of the double-leg floor ( p = 0.026), single-leg foam ( p = 0.010), double-leg foam ( p = 0.003), tandem floor ( p = 0.031), and tandem foam ( p = 0.038), while no significant change was found in single-leg floor performance ( p = 0.476). CG participants did not exhibit any significant change during the 10-week period. In summary, the study affirmed that the 10-week NMT program enhanced the postural control performance of youth ballroom dancers and showed effects on ballroom dance-specific performance and lower-limb injury prevention. The results suggest that NMT may be a valuable addition to ballroom dance training regimens.",2021,"Results of Modified-Balance Error Scoring System (M-BESS) showed that NMT participants displayed significantly decreased errors of the double-leg floor ( p = 0.026), single-leg foam ( p = 0.010), double-leg foam ( p = 0.003), tandem floor ( p = 0.031), and tandem foam ( p = 0.038), while no significant change was found in single-leg floor performance ( p = 0.476).","['Elite Youth Competitive Ballroom Dancers', 'Forty-two dancers (21 couples', 'elite youth competitive ballroom dancers']","['NMT program', '10-week neuromuscular training (NMT) program', 'NMT', '10-Week Neuromuscular Training', 'CG', 'YBT']","['double-leg foam', 'single-leg floor performance', 'errors of the double-leg floor', 'Y-balance test (YBT) and Modified-Balance Error', 'posterolateral and posteromedial directions', 'single-leg foam', 'postural control performance of youth ballroom dancers']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0335081', 'cui_str': 'Dancer'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332195', 'cui_str': 'Posterolateral'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0335081', 'cui_str': 'Dancer'}]",,0.075552,"Results of Modified-Balance Error Scoring System (M-BESS) showed that NMT participants displayed significantly decreased errors of the double-leg floor ( p = 0.026), single-leg foam ( p = 0.010), double-leg foam ( p = 0.003), tandem floor ( p = 0.031), and tandem foam ( p = 0.038), while no significant change was found in single-leg floor performance ( p = 0.476).","[{'ForeName': 'Meiqi', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Arts School, Beijing Sport University, Beijing, China.'}, {'ForeName': 'Hongtao', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'Arts School, Beijing Sport University, Beijing, China.'}, {'ForeName': 'Zhan', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Physical Education and Health Education, Springfield College, Springfield, MA, United States.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Smith', 'Affiliation': 'Department of Physical Education and Health Education, Springfield College, Springfield, MA, United States.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Arts School, Beijing Sport University, Beijing, China.'}]",Frontiers in physiology,['10.3389/fphys.2021.636209'] 4032,33841063,Measuring fidelity to delivery of a new smoking cessation intervention integrated into routine tuberculosis care in Pakistan and Bangladesh: Contextual differences and opportunities.,"INTRODUCTION Tobacco smoking among tuberculosis (TB) patients leads to poorer treatment outcomes. Smoking cessation support should be integrated into routine TB care. We measured healthcare providers' fidelity to a smoking cessation intervention integrated into routine TB care, in Bangladesh and Pakistan. We aimed to understand the role of providers and settings in the implementation of behavior support (BS) messages for TB and smoking cessation. METHODS The integrated BS intervention was implemented in TB clinics (24 public and 1 private). Cross-sectional data were collected on the fidelity of delivery of the BS intervention using a predefined fidelity index based on an existing validated method of measuring intervention fidelity. Audio-recordings of patient-provider BS sessions were coded using the fidelity index. Intervention fidelity was presented as the proportion of sessions that implemented BS messages. RESULTS A total of 96 sessions were conducted, 37 in Bangladesh and 59 in Pakistan. In public settings, TB medication advice was offered in 91.9% (95% CI: 78.7- 97.2) of sessions in Bangladesh, and in 75.5% (95% CI: 62.4-85.1) of sessions in Pakistan; whilst it was offered in 83.3% (95% CI: 43.7-97.0) of sessions in the private setting in Pakistan. Patients' smoking status was assessed in 70.3% (95% CI: 54.2-82.5) of sessions in Bangladesh, and in 34.0% (95% CI: 22.7-47.4) of sessions in the public setting and in 66.7% (95% CI: 30.0-90.3) of sessions in the private setting in Pakistan. A quit date was set in 32.4% (95% CI: 19.6-48.5) of all sessions in Bangladesh, and in 33.3% (95% CI: 9.6-70.0) of all sessions in the public setting in Pakistan. CONCLUSIONS Fidelity to the intended delivery of the intervention was found to be high for TB-related messages but not for smoking cessation messages. Clinic contexts may play a mediating role in health workers' opportunities to deliver the intervention as planned. TRIAL REGISTRATION International Standard Randomized Clinical Trial Number (ISRCTN43811467). Registered 23 March 2016, https://doi.org/10.1186/ISRCTN43811467.",2021,"A quit date was set in 32.4% (95% CI: 19.6-48.5) of all sessions in Bangladesh, and in 33.3% (95% CI: 9.6-70.0) of all sessions in the public setting in Pakistan. ","['Pakistan and Bangladesh', 'A total of 96 sessions were conducted, 37 in Bangladesh and 59 in Pakistan']",[],"['TB medication advice', 'smoking status']","[{'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",[],"[{'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.0698284,"A quit date was set in 32.4% (95% CI: 19.6-48.5) of all sessions in Bangladesh, and in 33.3% (95% CI: 9.6-70.0) of all sessions in the public setting in Pakistan. ","[{'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Boeckmann', 'Affiliation': 'School of Public Health, Bielefeld University, Bielefeld, Germany.'}, {'ForeName': 'Omara', 'Initials': 'O', 'LastName': 'Dogar', 'Affiliation': 'Department of Health Sciences, University of York, York, United Kingdom.'}, {'ForeName': 'Saima', 'Initials': 'S', 'LastName': 'Saeed', 'Affiliation': 'Indus Hospital, Karachi City, Pakistan.'}, {'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Majidulla', 'Affiliation': 'Indus Hospital, Karachi City, Pakistan.'}, {'ForeName': 'Shilpi', 'Initials': 'S', 'LastName': 'Swami', 'Affiliation': 'Evidera, London, United Kingdom.'}, {'ForeName': 'Amina', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'The Initiative, Islamabad, Pakistan.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Siddiqi', 'Affiliation': 'Department of Health Sciences, University of York, York, United Kingdom.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Kotz', 'Affiliation': 'Addiction Research and Clinical Epidemiology Unit, Institute of General Practice, Medical Faculty of the Heinrich-Heine-University, Düsseldorf, Germany.'}]",Tobacco induced diseases,['10.18332/tid/133054'] 4033,33841012,Effect of Korea red ginseng on nonalcoholic fatty liver disease: an association of gut microbiota with liver function.,"Background Korea Red Ginseng (KRG) has been used as remedies with hepato-protective effects in liver-related condition. Microbiota related gut-liver axis plays key roles in the pathogenesis of chronic liver disease. We evaluated the effect of KRG on gut-liver axis in patients with nonalcoholic statohepatitis by the modulation of gut-microbiota. Methods A total of 94 patients (KRG: 45 and placebo: 49) were prospectively randomized to receive KRG (2,000 mg/day, ginsenoside Rg1+Rb1+Rg3 4.5mg/g) or placebo during 30 days. Liver function test, cytokeraton 18, and fatigue score were measured. Gut microbiota was analyzed by MiSeq systems based on 16S rRNA genes. Results In KRG group, the mean levels (before vs. after) of aspartate aminotransferase (53 ± 19 vs. 45 ± 23 IU/L), alanine aminotransferase (75 ± 40 vs. 64 ± 39 IU/L) and fatigue score (33 ± 13 vs. 26 ± 13) were improved ( p  < 0.05). In placebo group, only fatigue score (34 ± 13 vs. 31 ± 15) was ameliorated ( p  < 0.05). The changes of phyla were not statistically significant on both groups. In KRG group, increased abundance of Lactobacillus was related with improved alanine aminotransferase level and increased abundance of Clostridium and Intestinibacter was associated with no improvement after KRG supplementation. In placebo group, increased abundance of Lachnospiraceae could be related with aggravation of liver enzyme ( p  < 0.05). Conclusion KRG effectively improved liver enzymes and fatigue score by modulating gut-microbiota in patients with fatty liver disease. Further studies are needed to understand the mechanism of improvement of nonalcoholic steatohepatitis. ClnicalTrialsgov NCT03945123 (www.ClinicalTrials.gov).",2021,"In placebo group, only fatigue score (34 ± 13 vs. 31 ± 15) was ameliorated ( p  < 0.05).","['gut microbiota with liver function', 'patients with fatty liver disease', 'patients with nonalcoholic statohepatitis by the modulation of gut-microbiota', '94 patients (KRG: 45 and']","['KRG', 'Korea red ginseng', '\n\n\nKorea Red Ginseng (KRG', 'placebo', 'ginsenoside Rg1+Rb1+Rg3 4.5mg/g) or placebo']","['abundance of Lactobacillus', 'fatigue score', 'Gut microbiota', 'liver enzymes and fatigue score', 'alanine aminotransferase (75\xa0±', 'abundance of Lachnospiraceae', 'aggravation of liver enzyme', 'nonalcoholic fatty liver disease', 'alanine aminotransferase level and increased abundance of Clostridium and Intestinibacter', 'Liver function test, cytokeraton 18, and fatigue score']","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0873137', 'cui_str': 'Korean ginseng preparation'}]","[{'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0873137', 'cui_str': 'Korean ginseng preparation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0061278', 'cui_str': 'Panaxosides'}]","[{'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C1210564', 'cui_str': 'Lachnospiraceae'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0009054', 'cui_str': 'Clostridium'}, {'cui': 'C0023901', 'cui_str': 'Hepatic function panel'}]",94.0,0.147235,"In placebo group, only fatigue score (34 ± 13 vs. 31 ± 15) was ameliorated ( p  < 0.05).","[{'ForeName': 'Ji Taek', 'Initials': 'JT', 'LastName': 'Hong', 'Affiliation': 'Institute for Liver and Digestive Diseases, Hallym University, Chuncheon, Republic of Korea.'}, {'ForeName': 'Min-Jung', 'Initials': 'MJ', 'LastName': 'Lee', 'Affiliation': 'Department of Life Science, Multidisciplinary Genome Institute, Hallym University, Chuncheon, Republic of Korea.'}, {'ForeName': 'Sang Jun', 'Initials': 'SJ', 'LastName': 'Yoon', 'Affiliation': 'Institute for Liver and Digestive Diseases, Hallym University, Chuncheon, Republic of Korea.'}, {'ForeName': 'Seok Pyo', 'Initials': 'SP', 'LastName': 'Shin', 'Affiliation': 'Institute for Liver and Digestive Diseases, Hallym University, Chuncheon, Republic of Korea.'}, {'ForeName': 'Chang Seok', 'Initials': 'CS', 'LastName': 'Bang', 'Affiliation': 'Institute for Liver and Digestive Diseases, Hallym University, Chuncheon, Republic of Korea.'}, {'ForeName': 'Gwang Ho', 'Initials': 'GH', 'LastName': 'Baik', 'Affiliation': 'Institute for Liver and Digestive Diseases, Hallym University, Chuncheon, Republic of Korea.'}, {'ForeName': 'Dong Joon', 'Initials': 'DJ', 'LastName': 'Kim', 'Affiliation': 'Institute for Liver and Digestive Diseases, Hallym University, Chuncheon, Republic of Korea.'}, {'ForeName': 'Gi Soo', 'Initials': 'GS', 'LastName': 'Youn', 'Affiliation': 'Institute for Liver and Digestive Diseases, Hallym University, Chuncheon, Republic of Korea.'}, {'ForeName': 'Min Jea', 'Initials': 'MJ', 'LastName': 'Shin', 'Affiliation': 'Institute for Liver and Digestive Diseases, Hallym University, Chuncheon, Republic of Korea.'}, {'ForeName': 'Young Lim', 'Initials': 'YL', 'LastName': 'Ham', 'Affiliation': 'Department of Nursing, Daewon University College, Jaecheon, Republic of Korea.'}, {'ForeName': 'Ki Tae', 'Initials': 'KT', 'LastName': 'Suk', 'Affiliation': 'Institute for Liver and Digestive Diseases, Hallym University, Chuncheon, Republic of Korea.'}, {'ForeName': 'Bong-Soo', 'Initials': 'BS', 'LastName': 'Kim', 'Affiliation': 'Department of Life Science, Multidisciplinary Genome Institute, Hallym University, Chuncheon, Republic of Korea.'}]",Journal of ginseng research,['10.1016/j.jgr.2020.07.004'] 4034,33840979,Association between Hamstring Flexibility and Sprint Speed after 8 Weeks of Yoga in Male Rugby Players.,"Background A Yoga-asana-based intervention has demonstrated its ability to improve flexibility of individuals, but has not been explored in rugby players. We hypothesized that a structured yoga intervention may have an effect on flexibility and sprint performance in male rugby union players. Methods It was a controlled trial research design and players were assigned using random sampling to one of the two groups; a yoga group ( n = 16) that practised yoga for 1 h 2 times a week for 8 weeks in addition to their normal rugby training and a control group ( n = 15) with regular rugby training but no yoga intervention. Yoga intervention included 32 yoga postures to address both the upper and lower extremities of the body. Data were collected during preseason and mid-season on hamstring flexibility (sit and reach test), and sprint performance (measured at 5, 10, and 30 m). Results One hundred and twenty participants were screened and thirty-one players volunteered for the study. Interactions between groups and differences between pre- and post-intervention scores were analyzed using analysis of variance using SPSS (version 24.0). Significance was set at an alpha level of P = 0.05. The yoga group showed a small nonsignificant decrease (-1.2% ± 21.4%, P = 0.05) in hamstring flexibility compared to the control group which demonstrated a large significant decrease (-14.8% ± 23.7%) (mean % change ± 95% confidence interval [CI], P < 0.05). The yoga group also showed minor nonsignificant improvements in sprint times -3.2% ± 10.4%, -0.7% ± 9.0% for the 5 and 10 m sprints, respectively, (mean % change ± 95% CI) compared to controls -0.4% ± 10.2%, 0.4% ± 7.9%. Conclusions Findings suggest that completing a structured yoga intervention alongside normal rugby training during the rugby season, yoga helped rugby players maintain their hamstring flexibility but did little to improve sprint performance during the season.",2021,"The yoga group also showed minor nonsignificant improvements in sprint times -3.2% ± 10.4%, -0.7% ± 9.0% for the 5 and 10 m sprints, respectively, (mean % change ± 95% CI) compared to controls -0.4% ± 10.2%, 0.4% ± 7.9%. ","['Male Rugby Players', 'One hundred and twenty participants were screened and thirty-one players volunteered for the study', 'male rugby union players']","['structured yoga intervention', 'practised yoga for 1 h 2 times a week for 8 weeks in addition to their normal rugby training and a control group ( n = 15) with regular rugby training but no yoga intervention', '\n\n\nA Yoga-asana-based intervention']","['hamstring flexibility (sit and reach test), and sprint performance', 'Hamstring Flexibility and Sprint Speed', 'hamstring flexibility', 'flexibility and sprint performance', 'sprint performance']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0233535', 'cui_str': 'Butting'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]",120.0,0.0540974,"The yoga group also showed minor nonsignificant improvements in sprint times -3.2% ± 10.4%, -0.7% ± 9.0% for the 5 and 10 m sprints, respectively, (mean % change ± 95% CI) compared to controls -0.4% ± 10.2%, 0.4% ± 7.9%. ","[{'ForeName': 'Tilak', 'Initials': 'T', 'LastName': 'Raj', 'Affiliation': 'Department of Tourism, Sport and Society, Lincoln University, Lincoln, New Zealand.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Hamlin', 'Affiliation': 'Department of Tourism, Sport and Society, Faculty of Environment, Society and Design, Lincoln University, Lincoln, New Zealand.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Elliot', 'Affiliation': 'Department of Tourism, Sport and Society, Faculty of Environment, Society and Design, Lincoln University, Lincoln, New Zealand.'}]",International journal of yoga,['10.4103/ijoy.IJOY_79_20'] 4035,33840975,Effect of Rāja yoga Meditation on Psychological and Functional Outcomes in Spinal Cord Injury Patients.,"Background Spinal cord injury (SCI) is a debilitating disorder with dysfunction in daily activities and psychological consequences like anxiety as well as depression impacting the quality of life substantially. Existing treatments focus mainly on rehabilitation, symptom reduction, and secondary complications. However, psychological, social, and existential issues are least addressed in the prevailing models. Aims To study the role of meditation in addressing psychological impairment and any resultant improvement in functional outcomes in SCI patients. Methods Nonrandomized controlled study was conducted in a tertiary care center for SCI patients. Hospital inpatients were recruited into either experimental intervention group (add on easy rāja yoga with conventional rehabilitation-ER n = 50) or control intervention group (conventional rehabilitation alone-CR n = 50). Patients in the ER group received easy rāja yoga for 1 month, along with conventional rehabilitation and the CR group patients received only conventional rehabilitation. All the subjects were assessed for psychological (perceived stress scale [PSS], Hospital Anxiety and Depression Scale [HADS]) and functional impairment (spinal cord independence measure (SCIM), numeric pain rating (NPR) and WHO quality of life-BRIEF (WHOQOLBREF)] at baseline and after 1 month. Results After 1 month of add-on easy rāja yoga , there was significant decrease in the scores of HADS (F[1,88] = 272.92, P < 0.001), PSS (F[1,88] = 274.41, P < 0.001) and NPR (F[1,88] = 60.60, P < 0.001) and significant increase in the scores of WHOQOLBREF (F[1,88] = 349.94, P < 0.001) and SCIM (F[1,88] = 29.09, P < 0.001) in the ER group compared to CR group in analysis of covariance. Conclusion One-month add-on easy rāja yoga improves psychological and functional outcomes (HADS, PSS, NPR, WHOQOLBREF and SCIM) in patients with SCI. Future studies with robust designs are needed to validate the results.",2021,"After 1 month of add-on easy rāja yoga , there was significant decrease in the scores of HADS (F[1,88] = 272.92, P < 0.001), PSS (F[1,88] =","['SCI patients', 'Hospital inpatients', 'patients with SCI', 'Spinal Cord Injury Patients', 'tertiary care center for SCI patients']","['Rāja yoga Meditation', 'easy rāja yoga for 1 month, along with conventional rehabilitation and the CR group patients received only conventional rehabilitation', 'experimental intervention group (add on easy rāja yoga with conventional rehabilitation-ER n = 50) or control intervention group (conventional rehabilitation alone-CR n = 50']","['psychological (perceived stress scale [PSS], Hospital Anxiety and Depression Scale [HADS]) and functional impairment (spinal cord independence measure (SCIM), numeric pain rating (NPR) and WHO quality of life-BRIEF (WHOQOLBREF', 'Psychological and Functional Outcomes', 'scores of HADS', 'SCIM', 'psychological and functional outcomes (HADS, PSS, NPR, WHOQOLBREF and SCIM', 'NPR', 'functional outcomes', 'scores of WHOQOLBREF']","[{'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0239966', 'cui_str': 'Hospital patient'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0037925', 'cui_str': 'Spinal cord structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0284507,"After 1 month of add-on easy rāja yoga , there was significant decrease in the scores of HADS (F[1,88] = 272.92, P < 0.001), PSS (F[1,88] =","[{'ForeName': 'Ekta', 'Initials': 'E', 'LastName': 'Chalageri', 'Affiliation': 'Spiritual Applications Research Centre of Rajyoga Education and Research Foundation of Brahma Kumaris, New Delhi, India.'}, {'ForeName': 'Gayatri', 'Initials': 'G', 'LastName': 'Vishwakarma', 'Affiliation': 'Indian Spinal Injuries Centre, New Delhi, India.'}, {'ForeName': 'Randhir Lal', 'Initials': 'RL', 'LastName': 'Ranjan', 'Affiliation': 'Indian Spinal Injuries Centre, New Delhi, India.'}, {'ForeName': 'Ramajayam', 'Initials': 'R', 'LastName': 'Govindaraj', 'Affiliation': 'Centre for Consciousness Studies, National Institute of Mental Health and Neurosciences, Bengaluru, Karnataka, India.'}, {'ForeName': 'Harvinder Singh', 'Initials': 'HS', 'LastName': 'Chhabra', 'Affiliation': 'Indian Spinal Injuries Centre, New Delhi, India.'}]",International journal of yoga,['10.4103/ijoy.IJOY_68_20'] 4036,33840960,Comparison of Oral and Intravenous N-acetyl Cysteine in Preventing Contrast Nephropathy.,"Introduction Despite high rates of morbidity and mortality in patients with contrast-induced nephropathy (CIN), there is no consensus regarding prevention of this well-known complication of contrast media use. One agent that has been widely used in this regard is N-acetyl cysteine (NAC). Nevertheless, its efficacy is still controversial. The aim of this study was to assess the efficacy of NAC, both in the oral and intravenous forms, for the prevention of CIN. Methods This study is a double-blind randomized placebo controlled clinical trial. We randomized 434 adult patients with chronic kidney disease (constant serum creatinine ≥1.5 mg/dL) who were candidates for coronary angiography/plasty. The patients were categorized into three groups. One group received 1,200 mg NAC intravenously half an hour before the procedure and oral placebo starting 3 days before angiography. The second group received oral NAC 600 mg twice daily for 3 days, starting the day before the intervention and intravenous placebo half an hour before intervention. The third group received both oral and intravenous placebo. CIN was defined as a 25% relative increase in serum creatinine from baseline value, 48 h after use of contrast medium. Results Of the 434 patients, 149 received intravenous NAC, 145 received oral NAC, and the remaining 140 received placebo. The incidence of CIN in the three groups was 6.1%, 7.6%, and 10.8%, respectively ( p = 0.34). Conclusion In patients with chronic kidney disease, neither intravenous nor oral NAC is superior to placebo for preventing CIN.",2020,"The incidence of CIN in the three groups was 6.1%, 7.6%, and 10.8%, respectively ( p = 0.34). ","['434 patients, 149 received', 'patients with contrast-induced nephropathy (CIN', 'patients with chronic kidney disease', '434 adult patients with chronic kidney disease (constant serum creatinine ≥1.5 mg/dL) who were candidates for coronary angiography/plasty']","['oral NAC', 'NAC', 'placebo', 'oral and intravenous placebo', 'Oral and Intravenous N-acetyl Cysteine', 'intravenous NAC']","['incidence of CIN', 'serum creatinine', 'morbidity and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",434.0,0.13933,"The incidence of CIN in the three groups was 6.1%, 7.6%, and 10.8%, respectively ( p = 0.34). ","[{'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Khatami', 'Affiliation': 'Nephrology Research Center, Imam Khomeini Hospital, Keshavarz Blvd, Tehran, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Nikravan', 'Affiliation': 'Nephrology Research Center, Imam Khomeini Hospital, Keshavarz Blvd, Tehran, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Salarifar', 'Affiliation': 'Tehran Herat Center, North Karegar Ave, Tehran, Iran.'}, {'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Poorhosseini', 'Affiliation': 'Tehran Herat Center, North Karegar Ave, Tehran, Iran.'}, {'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Sadeghian', 'Affiliation': 'Tehran Herat Center, North Karegar Ave, Tehran, Iran.'}, {'ForeName': 'Ali Mohammad', 'Initials': 'AM', 'LastName': 'Haj-Zeinali', 'Affiliation': 'Tehran Herat Center, North Karegar Ave, Tehran, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Aghajani', 'Affiliation': 'Tehran Herat Center, North Karegar Ave, Tehran, Iran.'}]",Indian journal of nephrology,['10.4103/ijn.IJN_260_19'] 4037,33840938,A comparative study of desflurane versus sevoflurane in obese patients: Effect on recovery profile.,"Background and Aims Anesthesia in obese patients is difficult due to associated comorbidities and altered physiology. Desflurane and sevoflurane have a low fat-blood solubility coefficient and are better suited in these patients to achieve a rapid emergence. We studied BIS guided drug titration to compare the postoperative recovery characteristics and cognitive function of desflurane versus sevoflurane in obese patients undergoing laparoscopic abdominal surgeries. Material and Methods After institutional ethics committee approval and written informed consent, sixty obese patients (BMI ≥30 kg/m 2 ) were randomized to receive either BIS guided desflurane or sevoflurane. Recovery was assessed by time taken for eye opening on verbal command, sustained head lift for 5 s, and extubation and orientation to time, place, and person after discontinuation of volatile anesthetic agent. For cognitive function, time taken to complete Mini mental state examination (MMSE) score to baseline was compared in both study groups. Results Difference of time taken for eye opening on verbal command, sustained head lift for 5 s, and extubation and orientation to time, place, and person was not significant between both anesthetic groups. Patients in sevoflurane group took significantly ( P -value = 0.001) less time (40.07 ± 13 min) to achieve preoperative MMSE score than desflurane group (51.2 ± 11.7 min). Conclusion Both desflurane and sevoflurane have similar recovery profile in obese patients when anesthetic concentration is carefully titrated. Reversal of cognitive function is significantly earlier in obese patients anesthetized with sevoflurane.",2020,"Patients in sevoflurane group took significantly ( P -value = 0.001) less time (40.07 ± 13 min) to achieve preoperative MMSE score than desflurane group (51.2 ± 11.7 min). ","['obese patients anesthetized with', 'sixty obese patients (BMI ≥30 kg/m 2 ', 'obese patients', 'obese patients undergoing laparoscopic abdominal surgeries']","['sevoflurane', 'Desflurane and sevoflurane', 'desflurane', 'BIS guided desflurane or sevoflurane', 'desflurane versus sevoflurane']","['verbal command, sustained head lift for 5 s, and extubation and orientation to time, place, and person', 'time taken for eye opening on verbal command, sustained head lift for 5 s, and extubation and orientation to time, place, and person after discontinuation of volatile anesthetic agent', 'For cognitive function, time taken to complete Mini mental state examination (MMSE) score', 'preoperative MMSE score']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1720436', 'cui_str': 'Under anesthesia'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0053723', 'cui_str': 'bis(cyclohexylammonium)'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0443769', 'cui_str': 'Volatile agent'}, {'cui': 'C0002932', 'cui_str': 'Anesthetic'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}]",60.0,0.0658377,"Patients in sevoflurane group took significantly ( P -value = 0.001) less time (40.07 ± 13 min) to achieve preoperative MMSE score than desflurane group (51.2 ± 11.7 min). ","[{'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Bansal', 'Affiliation': 'Department of Anaesthesiology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.'}, {'ForeName': 'Kamakshi', 'Initials': 'K', 'LastName': 'Garg', 'Affiliation': 'Department of Anaesthesiology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Katyal', 'Affiliation': 'Department of Anaesthesiology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Sood', 'Affiliation': 'Department of Anaesthesiology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.'}, {'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Grewal', 'Affiliation': 'Department of Anaesthesiology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.'}, {'ForeName': 'Arvind', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Department of Medicine, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_307_19'] 4038,33840932,Prophylactic low dose ketamine infusion for prevention of shivering during spinal anesthesia: A randomized double blind clinical trial.,"Background and Aims Regional anesthesia is known to produce perioperative hypothermia and shivering. We aimed to evaluate if prophylactic low dose ketamine bolus followed by infusion would prevent intraoperative and postoperative shivering under spinal anesthesia. Material and Methods Sixty patients belonging to American Society of Anaesthesiologists (ASA) 1 and 2 undergoing abdominal and lower limb surgery were randomized to receive either 0.2 mg/kg iv of ketamine bolus followed by infusion 0.1 mg/kg/hr (Group K) or5 ml of saline followed by 0.1 ml/kg/hr solution (Group S) as an infusion throughout the period of surgery. The incidence of shivering was the primary outcome of the study with degree of sedation and the hemodynamic profile between the two groups being the secondary outcomes. Hemodynamics (Heart rate, Mean Blood Pressure and temperature), Grade of shivering and grade of sedation were assessed intraoperatively and for grade of shivering and sedation two hours postoperatively. Repeated measures Analysis of Variance (ANOVA) was used to compare the hemodynamic variables and Chisquare test/Fisher's exact test to compare the grades of shivering and sedation between the two groups. Results Intraoperative shivering was seen in eighteen patients in saline group (58.06%) and only with four patients (13.79%) with ketamine group ( P < 0.001). Post operative shivering was also significantly less in ketamine group compared to saline ( P = 0.01). Also, patients who received ketamine had significant sedation in the intraoperative period ( P < 0.001). Conclusion Prophylactic low dose ketamine administered as a small bolus followed by an infusion was effective in preventing both intraoperative and postoperative shivering.",2020,Post operative shivering was also significantly less in ketamine group compared to saline ( P = 0.01).,"['Sixty patients belonging to American Society of Anaesthesiologists (ASA) 1 and 2 undergoing abdominal and lower limb surgery', 'shivering during spinal anesthesia']","['ketamine', 'ketamine bolus followed by infusion 0.1 mg/kg/hr (Group K) or5 ml of saline followed by 0.1 ml/kg/hr solution', 'Prophylactic low dose ketamine infusion']","['Hemodynamics (Heart rate, Mean Blood Pressure and temperature), Grade of shivering and grade of sedation', 'degree of sedation and the hemodynamic profile', 'Intraoperative shivering', 'Post operative shivering', 'incidence of shivering']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0036973', 'cui_str': 'Shivering or rigors'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C1320755', 'cui_str': 'mg/kg/hr'}, {'cui': 'C0441845', 'cui_str': 'Group K'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C1532580', 'cui_str': 'mL/kg/hr'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0036973', 'cui_str': 'Shivering or rigors'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",60.0,0.494202,Post operative shivering was also significantly less in ketamine group compared to saline ( P = 0.01).,"[{'ForeName': 'Ramyavel', 'Initials': 'R', 'LastName': 'Thangavelu', 'Affiliation': 'Department of Anaesthesiology, Pondicherry Institute of Medical Sciences, Pondicherry, India.'}, {'ForeName': 'Sagiev Koshy', 'Initials': 'SK', 'LastName': 'George', 'Affiliation': 'Department of Anaesthesiology, Pondicherry Institute of Medical Sciences, Pondicherry, India.'}, {'ForeName': 'Ravichandran', 'Initials': 'R', 'LastName': 'Kandasamy', 'Affiliation': 'Department of Biostatistics, Pondicherry Institute of Medical Sciences, Pondicherry, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_201_19'] 4039,33840930,Comparison and evaluation of single-use LMA supreme versus the reusable proseal LMA in paralyzed patients undergoing surgery with controlled ventilation.,"Background and Aims The objective of this prospective randomized blinded study was to assess the safety and efficacy of the laryngeal mask airway (LMA) Supreme as compared with the LMA Proseal. Material and Methods A total of 60 patients were randomised into two groups to either receive a Proseal LMA (PLMA) or Supreme LMA (SLMA) for airway management. The primary outcome was to measure oropharyngeal leak pressure (OLP) in both groups. The secondary outcomes were the measurement of insertion time, insertion success rate, fibreoptic grading, intracuff pressure, ease of ventilation, and airway pressure on standard ventilatory settings and postoperative complications. Results Intracuff pressure increase after 60 minutes of induction was significantly higher in the PLMA group (PLMA 97.43 ± 11.03 cm of H 2 O and SLMA 75.17 ± 8.95 cm of H 2 O). OLP was recorded after device insertion, after 30 min and after 60 min in each group and was found to be 28.71 ± 2.97, 30.93 ± 2.87, and 31.93 ± 2.72 cm of H 2 O in PLMA and 24.84 ± 2.08, 26.73 ± 2.26, and 27.95 ± 2.55 cm of H 2 O in SLMA group, respectively. The mean OLP with the SLMA was significantly (p=<.001) lower than PLMA. All the other parameters were comparable in both groups. Conclusion PLMA is better than SLMA as airway device to ventilate at higher airway pressure in paralyzed adult patients. On the basis of our study, we recommend Proseal over Supreme LMA.",2020,Intracuff pressure increase after 60 minutes of induction was significantly higher in the PLMA group (PLMA 97.43 ± 11.03 cm of H 2 O and SLMA 75.17 ± 8.95 cm of H 2 O).,"['paralyzed patients undergoing surgery with controlled ventilation', 'paralyzed adult patients', '60 patients']","['SLMA', 'PLMA', 'single-use LMA supreme versus the reusable proseal LMA', 'Proseal LMA (PLMA) or Supreme LMA (SLMA', 'laryngeal mask airway (LMA) Supreme']","['safety and efficacy', 'OLP', 'measurement of insertion time, insertion success rate, fibreoptic grading, intracuff pressure, ease of ventilation, and airway pressure on standard ventilatory settings and postoperative complications', 'mean OLP with the SLMA', 'oropharyngeal leak pressure (OLP', 'Intracuff pressure increase']","[{'cui': 'C0522224', 'cui_str': 'Paralysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0419011', 'cui_str': 'Controlled ventilation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3282376', 'cui_str': 'Supreme'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3282376', 'cui_str': 'Supreme'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0677038', 'cui_str': 'Increase in pressure'}]",60.0,0.104019,Intracuff pressure increase after 60 minutes of induction was significantly higher in the PLMA group (PLMA 97.43 ± 11.03 cm of H 2 O and SLMA 75.17 ± 8.95 cm of H 2 O).,"[{'ForeName': 'Suvidha', 'Initials': 'S', 'LastName': 'Sood', 'Affiliation': 'Department of Anesthesiology, ESI-PGIMSR, Basaidarapur, New Delhi, India.'}, {'ForeName': 'Shikha', 'Initials': 'S', 'LastName': 'Chahar', 'Affiliation': 'Department of Anesthesiology, ESI-PGIMSR, Basaidarapur, New Delhi, India.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Thakur', 'Affiliation': 'Department of Anesthesiology, ESI-PGIMSR, Basaidarapur, New Delhi, India.'}, {'ForeName': 'Madhu', 'Initials': 'M', 'LastName': 'Gupta', 'Affiliation': 'Department of Anesthesiology, ESI-PGIMSR, Basaidarapur, New Delhi, India.'}, {'ForeName': 'Anupriya', 'Initials': 'A', 'LastName': 'Saxena', 'Affiliation': 'Department of Anesthesiology, ESI-PGIMSR, Basaidarapur, New Delhi, India.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Subramanian', 'Affiliation': 'Department of Anesthesiology, Narayana Nethralaya, Bengaluru, Karnataka, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_298_18'] 4040,33840929,EC 50 of sevoflurane for classic laryngeal mask airway insertion in children at different time points: A randomized blind trial.,"Background and Aims Literature documents EC 50 (End-tidal) of sevoflurane for CLMA (Classic Laryngeal Mask airway) insertion between 1.5 and 2% and most of these studies suggest maintaining the required end-tidal sevoflurane concentration for 10-25 minutes before LMA insertion. Waiting for this long interval for blood brain sevoflurane equilibration may not be feasible in children especially during failed ventilation. We aimed to estimate EC 50 of sevoflurane for CLMA insertion at equilibration time points of 2.5 min and 5.0 min. Material and Methods In this randomized trial, children aged 2_8 years of either sex having American Society of Anesthesiologists status I undergoing elective cataract surgery were included. After inhalational induction of general anesthesia with 8% sevoflurane and 100% oxygen, intravenous cannulation was secured. The sevoflurane vaporizer was finely adjusted to maintain an end-tidal sevoflurane concentration at 2% for 2.5 min for first child in group 2.5 and 5 min in group 5.0. This was followed by LMA insertion which was considered to be unsuccessful if there was ""movement"" and successful if ""no movement"" occurred. End-tidal concentration was increased/decreased (step-size 0.2%) using Dixon and Massey up and down method in the next patient depending upon the previous patient's response. Results EC 50 of sevoflurane for insertion of classic LMA in children aged 2-8 yrs in 100% oxygen was 1.1% (0.9-1.2) at 2.5 min and 1.6% (1.5-1.7) at 5.0 min. Derived EC 95 (95% CI) at 2.5 min was 1.8% (1.5-9.2) and at 5.0 min was 1.8% (1.4-8.8) respectively. Conclusion We suggest maintaining end-tidal sevoflurane of 1.6% for 2.5 min and 1.8% for 5 min for successful CLMA insertion.",2020,"End-tidal concentration was increased/decreased (step-size 0.2%) using Dixon and Massey up and down method in the next patient depending upon the previous patient's response. ","['classic laryngeal mask airway insertion in children at different time points', 'I undergoing elective cataract surgery', 'children aged 2_8 years of either sex having American Society of Anesthesiologists status']","['sevoflurane', 'EC 50 of sevoflurane', 'sevoflurane and 100% oxygen, intravenous cannulation']","['tidal sevoflurane concentration', 'End-tidal concentration']","[{'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0396618', 'cui_str': 'Laryngeal mask airway insertion'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0398266', 'cui_str': 'Catheterization of vein'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444930', 'cui_str': 'End'}]",,0.136391,"End-tidal concentration was increased/decreased (step-size 0.2%) using Dixon and Massey up and down method in the next patient depending upon the previous patient's response. ","[{'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Sethi', 'Affiliation': 'Department of Anaesthesia, PGIMER, Chandigarh, India.'}, {'ForeName': 'Nitika', 'Initials': 'N', 'LastName': 'Goel', 'Affiliation': 'Department of Anaesthesia, PGIMER, Chandigarh, India.'}, {'ForeName': 'Babita', 'Initials': 'B', 'LastName': 'Ghai', 'Affiliation': 'Department of Anaesthesia, PGIMER, Chandigarh, India.'}, {'ForeName': 'Mantoliya N', 'Initials': 'MN', 'LastName': 'Sharma', 'Affiliation': 'Department of Anaesthesia, PGIMER, Chandigarh, India.'}, {'ForeName': 'Jagat', 'Initials': 'J', 'LastName': 'Ram', 'Affiliation': 'Department of Ophthalmology, PGIMER, Chandigarh, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_108_19'] 4041,33840928,Comparison of conventional C-MAC video laryngoscope guided intubation by anesthesia trainees with and without Frova endotracheal introducer: A randomized clinical trial.,"Background and Aims Successful intubation with video laryngoscopes necessitates good hand-eye coordination and the use of intubation adjuncts like bougie and stylet. We proposed this study to find whether using Frova introducer with C-MAC video laryngoscope will reduce the intubation time in trainee anesthesiologists. Material and Methods We enrolled 140 adults without any difficult airway predictors. They were randomly assigned to undergo C-MAC video laryngoscope guided intubation by anesthesia residents using tracheal tube preloaded over Frova introducer ( n = 70) or without Frova introducer ( n = 70). Primary outcome was the intubation time. Secondary outcomes were the number of redirections of tracheal tube or Frova introducer toward glottis, need for external laryngeal maneuvers (ELMs), first attempt intubation success rate, and ease of intubation. Results The median actual intubation time (IQR) in Frova and non-Frova group, respectively, were 25.46 (28.11-19.80) and 19.96 (26.59-15.52) s ( P = 0.001). The number of redirections of TT or Frova introducer toward glottis, first attempt success rate, and ease of intubation were comparable. The need for ELMs [ n (%)] was 15 (21.4) and 26 (37.1) in Frova and non-Frova group, respectively ( P = 0.04). Conclusion Frova introducer guided endotracheal intubation with C-MAC videolaryngoscope in patients with normal airways had a marginally prolonged intubation time with a significant reduction in the need of external laryngeal manoeuvres but with a comparable number of redirections and attempts. Further research is needed to generalize these findings to patients with difficult airways.",2020,"Results The median actual intubation time (IQR) in Frova and non-Frova group, respectively, were 25.46 (28.11-19.80) and 19.96 (26.59-15.52) s ( P = 0.001).","['patients with normal airways', 'anesthesia trainees with and without Frova endotracheal introducer', 'patients with difficult airways', '140 adults without any difficult airway predictors']","['Frova introducer with C-MAC video laryngoscope', 'C-MAC video laryngoscope guided intubation by anesthesia residents using tracheal tube preloaded over Frova introducer ( n = 70) or without Frova introducer', 'conventional C-MAC video laryngoscope guided intubation']","['need of external laryngeal manoeuvres', 'number of redirections of TT or Frova introducer toward glottis, first attempt success rate, and ease of intubation', 'prolonged intubation time', 'number of redirections of tracheal tube or Frova introducer toward glottis, need for external laryngeal maneuvers (ELMs), first attempt intubation success rate, and ease of intubation', 'intubation time', 'median actual intubation time (IQR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C1099778', 'cui_str': 'Frova'}, {'cui': 'C1522653', 'cui_str': 'Intratracheal route'}, {'cui': 'C0456642', 'cui_str': 'Introducer'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1099778', 'cui_str': 'Frova'}, {'cui': 'C0456642', 'cui_str': 'Introducer'}, {'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C1260970', 'cui_str': 'Tracheal tube'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1099778', 'cui_str': 'Frova'}, {'cui': 'C0456642', 'cui_str': 'Introducer'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1260970', 'cui_str': 'Tracheal tube'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",140.0,0.107112,"Results The median actual intubation time (IQR) in Frova and non-Frova group, respectively, were 25.46 (28.11-19.80) and 19.96 (26.59-15.52) s ( P = 0.001).","[{'ForeName': 'Meenupriya', 'Initials': 'M', 'LastName': 'Arasu', 'Affiliation': 'Department of Anesthesia and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Rudingwa', 'Affiliation': 'Department of Anesthesia and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.'}, {'ForeName': 'M V S', 'Initials': 'MVS', 'LastName': 'Satyaprakash', 'Affiliation': 'Department of Anesthesia and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.'}, {'ForeName': 'Sakthirajan', 'Initials': 'S', 'LastName': 'Panneerselvam', 'Affiliation': 'Department of Anesthesia and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.'}, {'ForeName': 'Aswini', 'Initials': 'A', 'LastName': 'Kuberan', 'Affiliation': 'Department of Anesthesia and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_263_20'] 4042,33847758,Randomized Controlled Trial of Cognitive-Behavioral and Mindfulness-Based Stress Reduction on the Quality of Life of Patients With Crohn Disease.,"BACKGROUND Patients with Crohn disease have debilitating psychological symptoms, mental fatigue, and poor quality of life. Psychological intervention may improve these symptoms. METHODS We performed a randomized parallel-group physician-blinded trial of cognitive-behavioral and mindfulness-based stress reduction (COBMINDEX) on quality of life and psychological symptoms in adults with mild-moderate Crohn disease. COBMINDEX was taught by social workers in one-on-one video conferences over 3 months; quotidian home practice was mandated. RESULTS Fifty-five COBMINDEX and 61 waitlist control patients completed the study; mean age was 33 years and 65% of participants were women. At 3 months, COBMINDEX patients had significantly reduced disease activity (per Harvey-Bradshaw Index score, C-reactive protein level, and calprotectin level), increased quality of life (Short Inflammatory Bowel Disease Questionnaire [SIBDQ] score increased from baseline 41 to 50; P < 0.001), decreased psychological symptoms (Global Severity Index [GSI], 0.98-0.70; P < 0.001), reduced fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue, 26-33; P < 0.001), and increased mindfulness disposition (Freiburg Mindfulness Inventory, 33-38; P < 0.001). Waitlist patients had a significant but small change in Harvey-Bradshaw Index, SIBDQ, and GSI scores, without improvement in fatigue or mindfulness. There were significant correlations (0.02 > P < 0.002) in COBMINDEX patients between baseline SIBDQ, GSI, Freiburg Mindfulness Inventory, and Functional Assessment of Chronic Illness Therapy-Fatigue scores with a relative change (baseline to 3 months) of the SIBDQ score, but none among waitlist patients. Predictors of relative change of the SIBDQ score in COBMINDEX patients included the GSI score (90% quantile; coefficient 0.52; P < 0.001), somatization (90%; 0.20; P = 0.001), depression (75%; 0.16; P = 0.03), and phobic anxiety (75%; 0.31; P = 0.008). CONCLUSIONS COBMINDEX was effective in increasing patients' quality of life and reducing psychological symptoms and fatigue. Patients with severe baseline psychological symptoms benefited the most from COBMINDEX.",2021,"Waitlist patients had a significant but small change in Harvey-Bradshaw Index, SIBDQ, and GSI scores, without improvement in fatigue or mindfulness.","['Fifty-five', 'Patients with Crohn disease', 'adults with mild-moderate Crohn disease', 'Patients With Crohn Disease', 'Patients with severe baseline psychological symptoms', '61 waitlist control patients completed the study; mean age was 33 years and 65% of participants were women']","['Psychological intervention', 'Cognitive-Behavioral and Mindfulness-Based Stress Reduction', 'cognitive-behavioral and mindfulness-based stress reduction (COBMINDEX']","['depression', 'GSI, Freiburg Mindfulness Inventory, and Functional Assessment of Chronic Illness Therapy-Fatigue scores', 'quality of life and psychological symptoms', 'disease activity (per Harvey-Bradshaw Index score, C-reactive protein level, and calprotectin level), increased quality of life (Short Inflammatory Bowel Disease Questionnaire [SIBDQ] score', 'SIBDQ score', 'Quality of Life', 'somatization', ""patients' quality of life and reducing psychological symptoms and fatigue"", 'psychological symptoms (Global Severity Index [GSI', 'reduced fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue', 'small change in Harvey-Bradshaw Index, SIBDQ, and GSI scores', 'phobic anxiety', 'fatigue or mindfulness', 'mindfulness disposition']","[{'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0619283', 'cui_str': 'IS 33'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0950624', 'cui_str': 'Calprotectin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0349231', 'cui_str': 'Phobia'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}]",,0.201347,"Waitlist patients had a significant but small change in Harvey-Bradshaw Index, SIBDQ, and GSI scores, without improvement in fatigue or mindfulness.","[{'ForeName': 'Ganit', 'Initials': 'G', 'LastName': 'Goren', 'Affiliation': 'Spitzer Department of Social Work, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Doron', 'Initials': 'D', 'LastName': 'Schwartz', 'Affiliation': 'Department of Gastroenterology and Hepatology, Soroka Medical Center, Beer Sheva, Israel.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Friger', 'Affiliation': 'Department of Public Health, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Hagar', 'Initials': 'H', 'LastName': 'Banai', 'Affiliation': 'Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Ruslan', 'Initials': 'R', 'LastName': 'Sergienko', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Regev', 'Affiliation': 'Spitzer Department of Social Work, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Heba', 'Initials': 'H', 'LastName': 'Abu-Kaf', 'Affiliation': 'Department of Gastroenterology and Hepatology, Soroka Medical Center, Beer Sheva, Israel.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Greenberg', 'Affiliation': 'Department of Health Systems Management, School of Public Health, Guilford Glazer Faculty of Business and Management, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Nemirovsky', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Karny', 'Initials': 'K', 'LastName': 'Ilan', 'Affiliation': 'The Shraga Segal Department of Microbiology and Immunology, Faculty of Health Sciences, The National Institute for Biotechnology in the Negev, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Livnat', 'Initials': 'L', 'LastName': 'Lerner', 'Affiliation': 'The Shraga Segal Department of Microbiology and Immunology, Faculty of Health Sciences, The National Institute for Biotechnology in the Negev, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Alon', 'Initials': 'A', 'LastName': 'Monsonego', 'Affiliation': 'The Shraga Segal Department of Microbiology and Immunology, Faculty of Health Sciences, The National Institute for Biotechnology in the Negev, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Dotan', 'Affiliation': 'Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Henit', 'Initials': 'H', 'LastName': 'Yanai', 'Affiliation': 'Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Eliakim', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Shomron', 'Initials': 'S', 'LastName': 'Ben Horin', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Vered', 'Initials': 'V', 'LastName': 'Slonim-Nevo', 'Affiliation': 'Spitzer Department of Social Work, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Shmuel', 'Initials': 'S', 'LastName': 'Odes', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Orly', 'Initials': 'O', 'LastName': 'Sarid', 'Affiliation': 'Spitzer Department of Social Work, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}]",Inflammatory bowel diseases,['10.1093/ibd/izab083'] 4043,33847426,Developing Signs of Safety: A Deaf-Accessible Counseling Toolkit for Trauma and Addiction.,"The U.S. Deaf community - more than half a million Americans who communicate using American Sign Language (ASL) - experiences higher rates of trauma exposure and substance use disorder (SUD) than the general population. Yet, there are no evidence-based treatments for any behavioral health condition that have been evaluated for use with Deaf people. The driving aim of our work, therefore, has been to develop and formally evaluate a Deaf-accessible trauma/SUD counseling approach. Here we describe our initial intervention development work and a single-arm pilot that evaluated the feasibility, acceptability, and preliminary clinical efficacy of Signs of Safety - a Deaf-accessible toolkit to be used with an existing, widely adopted protocol for trauma and addiction (Seeking Safety). Preliminary efficacy results indicated clinically significant reductions in PTSD symptoms and frequency of alcohol use for the Seeking Safety/Signs of Safety model. Frequency of drug use did not change significantly - likely attributable to the mid-study legalization of recreational marijuana in our state. Next steps include the redesign and refilming of Signs of Safety based on pilot participant feedback, again using a Deaf-engaged development and production process. This new toolkit will be tested via a pilot randomized controlled trial designed based on present methodological lessons learned.",2021,Preliminary efficacy results indicated clinically significant reductions in PTSD symptoms and frequency of alcohol use for the Seeking Safety/Signs of Safety model.,[],[],['PTSD symptoms and frequency of alcohol'],[],[],"[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]",,0.0293426,Preliminary efficacy results indicated clinically significant reductions in PTSD symptoms and frequency of alcohol use for the Seeking Safety/Signs of Safety model.,"[{'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Anderson', 'Affiliation': 'University of Massachusetts Medical School (UMMS), Implementation Science and Practice Advances Research Center (iSPARC), Shrewsbury, MA, USA.'}, {'ForeName': 'Neil S', 'Initials': 'NS', 'LastName': 'Glickman', 'Affiliation': 'University of Massachusetts Medical School (UMMS), Implementation Science and Practice Advances Research Center (iSPARC), Shrewsbury, MA, USA.'}, {'ForeName': 'Kelly S', 'Initials': 'KS', 'LastName': 'Wolf Craig', 'Affiliation': 'University of Massachusetts Medical School (UMMS), Implementation Science and Practice Advances Research Center (iSPARC), Shrewsbury, MA, USA.'}, {'ForeName': 'Amanda K', 'Initials': 'AK', 'LastName': 'Sortwell Crane', 'Affiliation': 'National Deaf Therapy, Evergreen, CO, USA.'}, {'ForeName': 'Alexander M', 'Initials': 'AM', 'LastName': 'Wilkins', 'Affiliation': 'University of Massachusetts Medical School (UMMS), Implementation Science and Practice Advances Research Center (iSPARC), Shrewsbury, MA, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Najavits', 'Affiliation': 'University of Massachusetts Medical School (UMMS), Implementation Science and Practice Advances Research Center (iSPARC), Shrewsbury, MA, USA.'}]",Clinical psychology & psychotherapy,['10.1002/cpp.2596'] 4044,33847366,Effectiveness of training in guideline-oriented biopsychosocial management of low-back pain in occupational health services - a cluster randomized controlled trial.,"Objective This study aimed to investigate the effectiveness of brief training in the guideline-oriented biopsychosocial management of low-back pain (LBP) in occupational health services using a cluster-randomized design. A small sample of physiotherapists and physicians from the intervention units (N=12) were given three- to seven-day training focusing on the biopsychosocial management of LBP, while professionals in the control units (N=15) received no such training. Methods Eligible patients with LBP, with or without radicular pain, aged 18-65, were invited to participate. A web-based questionnaire was sent to all recruited patients at baseline, three months and one year. The primary outcome measure was disability (Oswestry Disability Index, ODI) over one year. Between-group differences were analyzed using linear and generalized linear mixed models adjusted for baseline-response delay as well as variables showing between-group imbalance at baseline. Results The final study sample comprised 234 and 81 patients in the intervention and control groups, respectively at baseline, and 137 and 47 patients, respectively, at one year. At baseline, the mean duration of pain was longer in the intervention group (P=0.017), and pain-related fear concerning physical activity was lower (P=0.012). We observed no significant difference between the groups' primary outcome measure (adjusted one-year mean difference in the ODI: 2.3; 95% confidence interval -1.0-5.7; P=0.175) or most secondary outcomes. Conclusions Brief training in guideline-oriented biopsychosocial management of LBP for occupational health professionals did not appear to be effective in reducing patients' symptom over one-year follow-up compared to treatment as usual.",2021,Conclusions Brief training in guideline-oriented biopsychosocial management of LBP for occupational health professionals did not appear to be effective in reducing patients' symptom over one-year follow-up compared to treatment as usual.,"['Methods Eligible patients with LBP, with or without radicular pain, aged 18-65, were invited to participate', '234 and 81 patients in the intervention and control groups, respectively at baseline, and 137 and 47 patients, respectively, at one year', 'A small sample of physiotherapists and physicians from the intervention units (N=12) were given']","['guideline-oriented biopsychosocial management of low-back pain (LBP', 'three- to seven-day training focusing on the biopsychosocial management of LBP, while professionals in the control units (N=15) received no such training', 'brief training']","['mean duration of pain', 'disability (Oswestry Disability Index, ODI', 'pain-related fear concerning physical activity']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0278147', 'cui_str': 'Radicular pain'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C3873701', 'cui_str': 'Control unit'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0537478,Conclusions Brief training in guideline-oriented biopsychosocial management of LBP for occupational health professionals did not appear to be effective in reducing patients' symptom over one-year follow-up compared to treatment as usual.,"[{'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Ryynänen', 'Affiliation': 'Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland. katja.ryynanen@oulu.fi.'}, {'ForeName': 'Petteri', 'Initials': 'P', 'LastName': 'Oura', 'Affiliation': ''}, {'ForeName': 'Anna-Sofia', 'Initials': 'AS', 'LastName': 'Simula', 'Affiliation': ''}, {'ForeName': 'Riikka', 'Initials': 'R', 'LastName': 'Holopainen', 'Affiliation': ''}, {'ForeName': 'Maija', 'Initials': 'M', 'LastName': 'Paukkunen', 'Affiliation': ''}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Lausmaa', 'Affiliation': ''}, {'ForeName': 'Jouko', 'Initials': 'J', 'LastName': 'Remes', 'Affiliation': ''}, {'ForeName': 'Neill', 'Initials': 'N', 'LastName': 'Booth', 'Affiliation': ''}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Malmivaara', 'Affiliation': ''}, {'ForeName': 'Jaro', 'Initials': 'J', 'LastName': 'Karppinen', 'Affiliation': ''}]","Scandinavian journal of work, environment & health",['10.5271/sjweh.3959'] 4045,33847362,"A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 2b Trial of Cytisinicline in Adult Smokers (The ORCA-1 Trial).","INTRODUCTION Cytisinicline (known as cytisine), a nicotinic acetylcholine receptor partial agonist, is a smoking cessation aid currently marketed in Central and Eastern Europe using a 1.5mg/tablet 25-day downward titration schedule. No prior studies have evaluated other doses or administration schedules. This study evaluated effects of a higher dosage and simplified dosing schedule on drug efficacy and tolerability. METHODS ORCA-1 was a double-blind, randomized, placebo-controlled clinical trial that provided cytisinicline or placebo tablets plus behavioral support for 25 days. Adult smokers (> 10 cigarettes daily) committed to quitting smoking were randomized to compare 2 cytisinicline doses (1.5 mg and 3 mg) versus placebo, and 2 administration schedules [downward titration versus 3 times daily (TID)]. Primary outcome was reduction in expected cigarettes smoked at end of treatment; secondary outcomes were biochemically confirmed 7-day abstinence at Week 4 and continuous abstinence from Weeks 5 to 8. RESULTS Among 254 participants, those in cytisinicline arms (regardless of dose or schedule) had greater reductions in cigarettes smoked versus placebo, with differences observed in 3 cytisinicline arms statistically significant versus placebo. All cytisinicline arms had statistically significantly higher abstinence rates at Week 4 versus placebo. Both cytisinicline arms using TID schedules had statistically significantly higher continuous abstinence rates from Weeks 5 to 8 compared with placebo. Participants in the cytisinicline 3-mg TID arm had the highest abstinence rate. There were no safety concerns with either 1.5mg or 3mg cytisinicline. CONCLUSION Based on simpler dose scheduling, excellent tolerability, and best continued abstinence rate, cytisinicline 3mg TID was selected for future Phase 3 studies. IMPLICATIONS Although the 1.5mg 25-day titration schedule has been marketed in Central and Eastern Europe for decades, this study explored using a higher dosage and a simplified dosing schedule for impact on cytisinicline efficacy and tolerability. Based on these results, a Phase 3 program was initiated using cytisinicline 3 mg tablets on a TID schedule for potential market approval in the United States.",2021,All cytisinicline arms had statistically significantly higher abstinence rates at Week 4 versus placebo.,"['Adult smokers (> 10 cigarettes daily) committed to quitting smoking', 'Adult Smokers (The ORCA-1 Trial']","['cytisinicline or placebo', 'Placebo', 'Cytisinicline', 'placebo']","['abstinence rates', 'cytisinicline efficacy and tolerability', 'continuous abstinence rates', '7-day abstinence at Week 4 and continuous abstinence', 'drug efficacy and tolerability', 'highest abstinence rate', 'reduction in expected cigarettes smoked']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0995158', 'cui_str': 'Orcinus orca'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0056913', 'cui_str': 'cytisine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0056913', 'cui_str': 'cytisine'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}]",254.0,0.534693,All cytisinicline arms had statistically significantly higher abstinence rates at Week 4 versus placebo.,"[{'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Nides', 'Affiliation': 'Los Angeles Clinical Trials, Burbank, CA.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Rigotti', 'Affiliation': 'Tobacco Research and Treatment Center, Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Benowitz', 'Affiliation': 'University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Clarke', 'Affiliation': 'Achieve Life Sciences Inc., Seattle, WA.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Jacobs', 'Affiliation': 'Achieve Life Sciences Inc., Seattle, WA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntab073'] 4046,33840935,Effect of caudal bupivacaine alone and with adjuvant fentanyl and nalbuphine to minimize the catheter-related bladder discomfort after tubeless percutaneous nephrolithotomy: A prospective randomized study.,"Background and Aims Catheter-related bladder discomfort (CRBD) is a major cause of postoperative morbidity following urological procedures. The aim of this study was to compare the effect of caudal bupivacaine alone and with adjuvant fentanyl and nalbuphine to minimize the severity of CRBD after tubeless percutaneous nephrolithotomy (PCNL). Material and Methods A randomized prospective study was conducted on one hundred thirty-two (American society of Anaesthesiologist physical status I to II) patients who presented for tubeless PCNL under general anesthesia. Patients were randomly divided into four groups control (C), bupivacaine (B), bupivacaine-fentanyl (BF), and bupivacaine-nalbuphine (BN) by using computer-generated codes. All patients received local infiltration at the procedure site while Groups B, BF, and BN received caudal epidural block (CEB) under ultrasound guidance after conclusion of the procedure. Groups B, BF, and BN received bupivacaine alone, bupivacaine-fentanyl, and bupivacaine-nalbuphine, respectively, for CEB. Patients were monitored 24 h for CRBD scale, visual analogue score (VAS), and duration of analgesia at 30 min, 1, 2, 4, 6, 12, 18, and 24 h intervals. The analgesics were supplemented if the CRBD score was >2 and VAS was ≥4. Student t-test, analysis of variance, and Chi-square test were applied for quantitative, within group occurrence, and qualitative analysis respectively. Results The CRBD scores were considerably lower in the Groups BF and BN as compared to Groups C and B during the first four hours. The duration of analgesia was significantly prolonged in Group BN (475 ± 47 min) versus BF (320 ± 68 min) versus B (104 ± 40 min) versus C (26 ± 14 min). Conclusions The severity of CRBD can be reduced with CEB. The effect of CEB can be prolonged with the addition of opioid.",2020,"The duration of analgesia was significantly prolonged in Group BN (475 ± 47 min) versus BF (320 ± 68 min) versus B (104 ± 40 min) versus C (26 ± 14 min). ","['one hundred thirty-two (American society of Anaesthesiologist physical status I to II) patients who presented for tubeless PCNL under general anesthesia', 'catheter-related bladder discomfort after tubeless percutaneous nephrolithotomy']","['bupivacaine (B), bupivacaine-fentanyl (BF), and bupivacaine-nalbuphine (BN) by using computer-generated codes', 'adjuvant fentanyl and nalbuphine', 'CEB', 'bupivacaine', 'tubeless percutaneous nephrolithotomy (PCNL', 'caudal bupivacaine alone and with adjuvant fentanyl and nalbuphine', 'caudal bupivacaine', 'bupivacaine-fentanyl, and bupivacaine-nalbuphine', 'caudal epidural block (CEB']","['duration of analgesia', 'severity of CRBD', 'CRBD scores', 'CRBD scale, visual analogue score (VAS), and duration of analgesia']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0549391', 'cui_str': 'Bladder discomfort'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0027348', 'cui_str': 'Nalbuphine'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0394837', 'cui_str': 'Local anesthetic sacral epidural block'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0205097', 'cui_str': 'Caudal'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0549391', 'cui_str': 'Bladder discomfort'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]",,0.0109131,"The duration of analgesia was significantly prolonged in Group BN (475 ± 47 min) versus BF (320 ± 68 min) versus B (104 ± 40 min) versus C (26 ± 14 min). ","[{'ForeName': 'Dinesh J', 'Initials': 'DJ', 'LastName': 'Prajapati', 'Affiliation': 'Department of Anaesthesiology, Muljibhai Patel Urological Hospital, Nadiad, Gujarat, India.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'Department of Anaesthesiology, Muljibhai Patel Urological Hospital, Nadiad, Gujarat, India.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Department of Anaesthesiology, Muljibhai Patel Urological Hospital, Nadiad, Gujarat, India.'}, {'ForeName': 'Mohankumar', 'Initials': 'M', 'LastName': 'Vijayakumar', 'Affiliation': 'Department of Anaesthesiology, Muljibhai Patel Urological Hospital, Nadiad, Gujarat, India.'}, {'ForeName': 'Arvind', 'Initials': 'A', 'LastName': 'Ganpule', 'Affiliation': 'Department of Anaesthesiology, Muljibhai Patel Urological Hospital, Nadiad, Gujarat, India.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Mistry', 'Affiliation': 'Department of Anaesthesiology, Muljibhai Patel Urological Hospital, Nadiad, Gujarat, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_285_18'] 4047,33840934,Premedication with pregabalin 150mg versus 300mg for postoperative pain relief after laparoscopic cholecystectomy.,"Background and Aims Pregabalin has been used in various studies for postoperative pain relief in varying doses. However, there is no conclusive evidence to support a safe and effective dose of pregabalin. The present study was designed to compare the efficacy of two different preoperative doses of pregabalin (150 mg and 300mg) in patients undergoing laparoscopic cholecystectomy for postoperative pain relief. Material and Methods Ninety adult patients of either sex with American Society of Anesthesiologist physical status I and II scheduled for elective laparoscopic cholecystectomy under general anesthesia were randomized to receive pregabalin 150mg (group A), pregabalin 300mg (group B), or placebo (group C) orally 1 h before surgery. The pain was assessed using a visual analog scale (VAS) and a verbal rating scale (VRS) for the initial 24 h postoperatively. The primary outcome of our study was the comparative assessment of the severity of pain in the postoperative period in three groups. Postoperative analgesic consumption and incidence of side effects were assessed as secondary outcome measures. Results VAS score was significantly more in group C than group A and B ( P -value <0.05). The total amount of fentanyl required in 24 h was least in group B (228.33 ± 42.41μg) followed by group A (292.50 ± 46.49μg) and group C (322.50 ± 39.58μg) ( P -value 0.0001). The incidence of sedation, dizziness, and visual disturbances was more in group B as compared to group A and was least in group C. Conclusions Pregabalin 150 mg is effective in decreasing postoperative pain after laparoscopic cholecystectomy with fewer incidences of adverse effects such as sedation and visual disturbances as compared to pregabalin 300 mg.",2020,"Results VAS score was significantly more in group C than group A and B ( P -value <0.05).","['after laparoscopic cholecystectomy', 'patients undergoing laparoscopic cholecystectomy for postoperative pain relief', 'Ninety adult patients of either sex with American Society of Anesthesiologist physical status I and II scheduled for elective laparoscopic cholecystectomy under general anesthesia']","['pregabalin', 'Pregabalin', 'pregabalin 300mg (group B), or placebo']","['pain', 'VAS score', 'Postoperative analgesic consumption and incidence of side effects', 'total amount of fentanyl', 'incidence of sedation, dizziness, and visual disturbances', 'visual analog scale (VAS) and a verbal rating scale (VRS', 'postoperative pain relief', 'severity of pain', 'postoperative pain']","[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C1649613', 'cui_str': 'pregabalin 300 MG [Lyrica]'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0547030', 'cui_str': 'Visual disturbance'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0458261', 'cui_str': 'Verbal rating scale'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",90.0,0.0155972,"Results VAS score was significantly more in group C than group A and B ( P -value <0.05).","[{'ForeName': 'Tanveer', 'Initials': 'T', 'LastName': 'Singh', 'Affiliation': 'Department of Anaesthesia, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.'}, {'ForeName': 'Suneet', 'Initials': 'S', 'LastName': 'Kathuria', 'Affiliation': 'Department of Anaesthesia, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.'}, {'ForeName': 'Richa', 'Initials': 'R', 'LastName': 'Jain', 'Affiliation': 'Department of Anaesthesia, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Sood', 'Affiliation': 'Department of Anaesthesia, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.'}, {'ForeName': 'Shikha', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Department of Anaesthesia, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_440_19'] 4048,33840933,Comparative study of hemodynamic effects of intrathecal bupivacaine with butorphanol in cardiac and non-cardiac patients.,"Background and Aims The synergism between intrathecal opioids and low dose local anesthetics makes it possible to achieve reliable spinal anesthesia (SA) with minimal hypotension. The study objective was to compare the hemodynamic effects of reduced dose of 0.5% intrathecal bupivacaine (2mL) with 25 μg butorphanol in cardiac vs non-cardiac patients. Material and Methods We included sixty patients aged 30-80 years, undergoing infraumbilical surgeries in the study and compared thirty cardiac patients with mild to moderate reduction in left ventricular ejection fraction (LVEF) on 2D echocardiography (Group C) with 30 non-cardiac patients (Group NC) for similar types of surgery. Both the groups received 0.5% bupivacaine 2.0 ml with 25 μg butorphanol. Results The spinal block characteristics were similar in both groups ( P > 0.05). The blood pressure of the patients in the two groups was comparable till 80 min P > 0.05 after which Group NC had significant increase in blood pressure compared to Group C upto 95 min ( P < 0.05). Similarly, heart rate was comparable until 90 min ( P > 0.05) after which Group NC had significant increase in heart rate versus Group C upto 100 min ( P < 0.05). Eight patients in group C and five patients in group NC showed hypotension. Bradycardia was seen in 4 patients in group C in comparison to only one patient in group NC. Conclusion We can safely consider spinal anesthesia with 10 mg bupivacaine and 25μg butorphanol in cardiac patients with mild to moderately reduced ejection fraction presenting for infraumbilical non-cardiac surgeries with the advantage of intraoperative hemodynamic stability and adequate postoperative analgesia.",2020,The blood pressure of the patients in the two groups was comparable till 80 min P > 0.05 after which Group NC had significant increase in blood pressure compared to Group C upto 95 min ( P < 0.05).,"['cardiac and non-cardiac patients', 'sixty patients aged 30-80 years, undergoing infraumbilical surgeries in the study and compared thirty cardiac patients with mild to moderate reduction in left ventricular ejection fraction (LVEF) on 2D echocardiography (Group C) with 30 non-cardiac patients (Group NC) for similar types of surgery', 'cardiac vs non-cardiac patients', 'cardiac patients with mild to moderately reduced ejection fraction presenting for infraumbilical non-cardiac surgeries with the advantage of intraoperative hemodynamic stability and adequate postoperative analgesia']","['intrathecal bupivacaine (2mL', 'intrathecal bupivacaine', 'butorphanol', 'bupivacaine']","['blood pressure', 'heart rate', 'hemodynamic effects', 'spinal block characteristics', 'hypotension', 'Bradycardia']","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0013524', 'cui_str': 'Echocardiography, 2D'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]","[{'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0006491', 'cui_str': 'Butorphanol'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}]",60.0,0.0271674,The blood pressure of the patients in the two groups was comparable till 80 min P > 0.05 after which Group NC had significant increase in blood pressure compared to Group C upto 95 min ( P < 0.05).,"[{'ForeName': 'Ruchi', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Department of Anaesthesia, Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar, Punjab, India.'}, {'ForeName': 'Deepika', 'Initials': 'D', 'LastName': 'Arora', 'Affiliation': 'Department of Anaesthesia, Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar, Punjab, India.'}, {'ForeName': 'Shubhdeep', 'Initials': 'S', 'LastName': 'Kaur', 'Affiliation': 'Department of Anaesthesia, Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar, Punjab, India.'}, {'ForeName': 'Balpreet', 'Initials': 'B', 'LastName': 'Kaur', 'Affiliation': 'Department of Anaesthesia, Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar, Punjab, India.'}, {'ForeName': 'Sukhvir', 'Initials': 'S', 'LastName': 'Kaur', 'Affiliation': 'Department of Anaesthesia, Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar, Punjab, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_70_20'] 4049,33847977,Embryo Morphokinetics and Blastocyst Development After GnRH Agonist versus hCG Triggering in Normo-ovulatory Women: a Secondary Analysis of a Multicenter Randomized Controlled Trial.,"Gonadotropin-releasing hormone agonist (GnRHa) for final oocyte maturation, along with vitrification of all usable embryos followed by transfer in a subsequent frozen-thawed cycle, is the most effective strategy to avoid ovarian hyperstimulation syndrome (OHSS). However, less is known about the ovulation induction triggers effect on early embryo development and blastocyst formation. This study is a secondary analysis of a multicenter, randomized controlled trial, with the aim to compare embryo development in normo-ovulatory women, randomized to GnRHa or human chorionic gonadotropin (hCG) trigger. In all, 4056 retrieved oocytes were observed, 1998 from the GnRHa group (216 women) and 2058 from the hCG group (218 women). A number of retrieved oocytes, mature and fertilized oocytes, and high-quality embryos and blastocysts were similar between the groups. A sub-analysis in 250 women enrolled at the main trial site including 2073 oocytes was conducted to compare embryo morphokinetics and cleavage patterns with EmbryoScope time-lapse system. In total, 1013 oocytes were retrieved from the GnRHa group (124 women) and 1060 oocytes were retrieved from the hCG group (126 women). Morphokinetic parameters and cleavage patterns were comparable between the groups. However, embryos derived from the GnRHa group were less likely to perform rolling during their development than the embryos from the hCG trigger group (OR = 0.41 (95%CI 0.25; 0.67), p-value 0.0003). The comparable results on embryo development and utilization rates between the GnRHa and hCG triggers is of clinical relevance to professionals and infertile patients, when GnRHa trigger and freeze-all is performed to avoid OHSS development. ClinicalTrials.gov Identifier: NCT02746562.",2021,"The comparable results on embryo development and utilization rates between the GnRHa and hCG triggers is of clinical relevance to professionals and infertile patients, when GnRHa trigger and freeze-all is performed to avoid OHSS development.","['normo-ovulatory women', 'Normo-ovulatory Women', '4056 retrieved oocytes were observed, 1998 from the GnRHa group (216 women) and 2058 from the hCG group (218 women', 'In total, 1013 oocytes were retrieved from the GnRHa group (124 women) and 1060 oocytes were retrieved from the hCG group (126 women', '250 women enrolled at the main trial site including 2073 oocytes was conducted to compare embryo morphokinetics and cleavage patterns with EmbryoScope time-lapse system']","['GnRH Agonist versus hCG', 'Gonadotropin-releasing hormone agonist (GnRHa', 'GnRHa or human chorionic gonadotropin (hCG']","['retrieved oocytes, mature and fertilized oocytes, and high-quality embryos and blastocysts', 'embryo development and utilization rates', 'Morphokinetic parameters and cleavage patterns', 'Embryo Morphokinetics and Blastocyst Development']","[{'cui': 'C0429470', 'cui_str': 'Ovulatory'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement'}, {'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0010813', 'cui_str': 'Cytokinesis'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0752061', 'cui_str': 'Embryoscopes'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement'}]","[{'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0029974', 'cui_str': 'Ovum'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C1281743', 'cui_str': 'Blastocyst structure'}, {'cui': 'C0013936', 'cui_str': 'Embryo Development'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0010813', 'cui_str': 'Cytokinesis'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",250.0,0.158826,"The comparable results on embryo development and utilization rates between the GnRHa and hCG triggers is of clinical relevance to professionals and infertile patients, when GnRHa trigger and freeze-all is performed to avoid OHSS development.","[{'ForeName': 'Evaggelia', 'Initials': 'E', 'LastName': 'Alexopoulou', 'Affiliation': 'The Fertility Clinic, Department of Obstetrics and Gynecology, Copenhagen University Hospital Hvidovre, Kettegård Alle 30, DK-2650, Hvidovre, Denmark. Evangelia.alexopoulou.02@regionh.dk.'}, {'ForeName': 'Sacha', 'Initials': 'S', 'LastName': 'Stormlund', 'Affiliation': 'The Fertility Clinic, Department of Obstetrics and Gynecology, Copenhagen University Hospital Hvidovre, Kettegård Alle 30, DK-2650, Hvidovre, Denmark.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Løssl', 'Affiliation': 'The Fertility Clinic, Copenhagen University Hospital Rigshospitalet, Blegdamsvej 9, DK-2100, Copenhagen Ø, Denmark.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Prætorius', 'Affiliation': 'The Fertility Clinic, Department of Obstetrics and Gynecology, Copenhagen University Hospital Hvidovre, Kettegård Alle 30, DK-2650, Hvidovre, Denmark.'}, {'ForeName': 'Negjyp', 'Initials': 'N', 'LastName': 'Sopa', 'Affiliation': 'The Fertility Clinic, Department of Obstetrics and Gynecology, Copenhagen University Hospital Hvidovre, Kettegård Alle 30, DK-2650, Hvidovre, Denmark.'}, {'ForeName': 'Jeanette Wulff', 'Initials': 'JW', 'LastName': 'Bogstad', 'Affiliation': 'The Fertility Clinic, Department of Obstetrics and Gynecology, Copenhagen University Hospital Hvidovre, Kettegård Alle 30, DK-2650, Hvidovre, Denmark.'}, {'ForeName': 'Anne Lis', 'Initials': 'AL', 'LastName': 'Mikkelsen', 'Affiliation': 'The Fertility Clinic, Department of Obstetrics and Gynecology, Sealland University Hospital Køge, Lykkebækvej 1, DK-4600, Køge, Denmark.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Forman', 'Affiliation': 'Section of Biostatistics, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5B, DK-1014, Copenhagen, Denmark.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'la Cour Freiesleben', 'Affiliation': 'The Fertility Clinic, Department of Obstetrics and Gynecology, Copenhagen University Hospital Hvidovre, Kettegård Alle 30, DK-2650, Hvidovre, Denmark.'}, {'ForeName': 'Janni', 'Initials': 'J', 'LastName': 'Vikkelsø Jeppesen', 'Affiliation': 'The Fertility Clinic, Copenhagen University Hospital Rigshospitalet, Blegdamsvej 9, DK-2100, Copenhagen Ø, Denmark.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Bergh', 'Affiliation': 'Department of Obstetrics and Gynecology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Reproductive Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Peter Samir Heskjær', 'Initials': 'PSH', 'LastName': 'Al Humaidan', 'Affiliation': 'The Fertility Clinic, Skive Regional Hospital, Faculty of Health Aarhus University, Resenvej 25, Skive, 7800, Denmark.'}, {'ForeName': 'Marie Louise', 'Initials': 'ML', 'LastName': 'Grøndahl', 'Affiliation': 'The Fertility Clinic, Department of Obstetrics and Gynecology, Copenhagen University Hospital Herlev, Borgmester Ib Juuls vej 9, DK-2750, Herlev, Denmark.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Zedeler', 'Affiliation': 'The Fertility Clinic, Department of Obstetrics and Gynecology, Copenhagen University Hospital Hvidovre, Kettegård Alle 30, DK-2650, Hvidovre, Denmark.'}, {'ForeName': 'Anja Bisgaard', 'Initials': 'AB', 'LastName': 'Pinborg', 'Affiliation': 'The Fertility Clinic, Department of Obstetrics and Gynecology, Copenhagen University Hospital Hvidovre, Kettegård Alle 30, DK-2650, Hvidovre, Denmark.'}]","Reproductive sciences (Thousand Oaks, Calif.)",['10.1007/s43032-021-00564-9'] 4050,33847862,Gender differences with short-term vs 12 months dual antiplatelet therapy in patients with acute coronary syndrome treated with the COMBO dual therapy stent: 2-years follow-up results of the REDUCE trial.,"BACKGROUND Gender differences in the thrombotic and bleeding risk have been suggested to condition the benefits of antithrombotic therapies in Acute Coronary Syndrome (ACS) patients, and mainly among those undergoing percutaneous coronary interventions with drug eluting stents (DES). The impact of gender on the optimal duration of dual antiplatelet therapy (DAPT) in ACS patients is still unexplored and was, therefore, the aim of the present sub-study. METHODS REDUCE was a prospective, multicenter, randomized investigator-initiated study designed to enroll 1500 ACS patients after treatment with the COMBO Dual Stent Therapy, based on a noninferiority design. Patients were randomized in a 1:1 fashion to either 3 or 12 months of DAPT. Primary study endpoint was a composite of all-cause mortality, myocardial infarction, definite/probable stent thrombosis (ST), stroke, target-vessel revascularization (TVR) and bleedings (BARC II, III, V) at 12 months. Secondary endpoints were cardiovascular mortality and the individual components of the primary endpoint within 24 months. RESULTS From June 2014 to May 2016 300 women and 1196 men were included in the study. Among them, 43.7% of females and 51.9% of males were assigned to the 3 months DAPT treatment. Baseline characteristics were well matched between the two arms, with the exception of a lower rate of TIMI flow < 3 (p = 0.04), lower systolic blood pressure (p = 0.05) and use of spironolactone (p = 0.006) among women and a more advanced age (p = 0.05) among men receiving a short-term DAPT. At a mean follow-up of 525 (± 198) days, no difference in the primary endpoint was observed according to DAPT duration in both females [6.9% vs 5.9%, HR (95% CI) = 1.19 (0.48-2.9), p = 0.71] and males [8.2% vs 9%, HR (95% CI) = 0.92 (0.63-1.35), p = 0.67; p INT = 0.20]. Results were confirmed after correction for baseline differences [females: adjusted HR (95% CI) = 1.12 (0.45-2.78), p = 0.81; males: adjusted HR (95% CI) = 0.90 (0.61-1.32), p = 0.60]. Comparable rates of survival, thrombotic (MI, stent thrombosis, TVR, stroke) and bleeding events were observed with the two DAPT strategies, with no impact of gender. CONCLUSIONS The present study shows that among ACS patients randomized in the REDUCE trial, a 3 months DAPT strategy offers comparable results as compared to a standard 12 months DAPT at 2-years follow-up in both male and female gender.",2021,"Comparable rates of survival, thrombotic (MI, stent thrombosis, TVR, stroke) and bleeding events were observed with the two DAPT strategies, with no impact of gender. ","['From June 2014 to May 2016 300 women and 1196 men were included in the study', '1500 ACS patients after treatment with the COMBO Dual Stent Therapy, based on a noninferiority design', 'Acute Coronary Syndrome (ACS) patients, and mainly among those undergoing percutaneous coronary interventions with drug eluting stents (DES', 'ACS patients', 'patients with acute coronary syndrome treated with the COMBO dual therapy stent']","['DAPT', 'spironolactone', 'dual antiplatelet therapy (DAPT']","['cardiovascular mortality and the individual components of the primary endpoint within 24\xa0months', 'composite of all-cause mortality, myocardial infarction, definite/probable stent thrombosis (ST), stroke, target-vessel revascularization (TVR) and bleedings (BARC II, III, V', 'lower systolic blood pressure', 'DAPT duration', 'survival, thrombotic (MI, stent thrombosis, TVR, stroke) and bleeding events', 'rate of TIMI flow']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0277885', 'cui_str': 'Decreased systolic arterial pressure'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",300.0,0.109172,"Comparable rates of survival, thrombotic (MI, stent thrombosis, TVR, stroke) and bleeding events were observed with the two DAPT strategies, with no impact of gender. ","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Verdoia', 'Affiliation': 'AOU Maggiore Della Carità, Eastern Piedmont University, Novara, Italy.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Suryapranata', 'Affiliation': 'Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Damen', 'Affiliation': 'Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Camaro', 'Affiliation': 'Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Benit', 'Affiliation': 'Jessa Ziekenhuis, Hasselt, Belgium.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Barbieri', 'Affiliation': 'AOU Maggiore Della Carità, Eastern Piedmont University, Novara, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rasoul', 'Affiliation': 'Atrium Medical Center, Heerlen, The Netherlands.'}, {'ForeName': 'H B', 'Initials': 'HB', 'LastName': 'Liew', 'Affiliation': 'Queen Elizabeth II, Sabah, Malaysia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Polad', 'Affiliation': ""Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, The Netherlands.""}, {'ForeName': 'W A W', 'Initials': 'WAW', 'LastName': 'Ahmad', 'Affiliation': 'University Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Zambahari', 'Affiliation': 'National Heart Institute, Kuala Lumpur, Malaysia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lalmand', 'Affiliation': 'Centre Hospitalier Universitaire, Charleroi, Belgium.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'van der Schaaf', 'Affiliation': 'Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.'}, {'ForeName': 'T H', 'Initials': 'TH', 'LastName': 'Koh', 'Affiliation': 'National Heart Center, Singapore, Singapore.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Timmermans', 'Affiliation': 'Jessa Ziekenhuis, Hasselt, Belgium.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Dilling-Boer', 'Affiliation': 'Jessa Ziekenhuis, Hasselt, Belgium.'}, {'ForeName': 'L F', 'Initials': 'LF', 'LastName': 'Veenstra', 'Affiliation': 'Atrium Medical Center, Heerlen, The Netherlands.'}, {'ForeName': 'A W J', 'Initials': 'AWJ', 'LastName': ""Van't Hof"", 'Affiliation': 'Isala Hospital, Zwolle, The Netherlands.'}, {'ForeName': 'S W L', 'Initials': 'SWL', 'LastName': 'Lee', 'Affiliation': 'Queen Mary Hospital, University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Roolvink', 'Affiliation': 'Isala Hospital, Zwolle, The Netherlands.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ligtenberg', 'Affiliation': 'OrbusNeich Medical BV, Hoevelaken, The Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Postma', 'Affiliation': 'Diagram BV, Zwolle, The Netherlands.'}, {'ForeName': 'E J J', 'Initials': 'EJJ', 'LastName': 'Kolkman', 'Affiliation': 'Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Brouwer', 'Affiliation': 'Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kedhi', 'Affiliation': 'Erasmus Hospital, Bruxelles, Belgium.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'De Luca', 'Affiliation': 'AOU Maggiore Della Carità, Eastern Piedmont University, Novara, Italy. giuseppe.deluca@med.uniupo.it.'}]",Journal of thrombosis and thrombolysis,['10.1007/s11239-021-02439-x'] 4051,33847856,"Efficacy and safety of 188 Re-HEDP in lung cancer patients with bone metastases: a randomized, multicenter, multiple-dose phase IIa study.","PURPOSE To investigate the pain-relieving effect and safety of three different doses of 188 Re-hydroxyethylidine diphosphonate (HEDP) in patients with lung cancer and bone metastases. METHODS For this randomised, phase 2 and multicenter trial, we enrolled patients with lung carcinoma and multifocal bone metastases and excluded patients who had received bisphosphonates or external-beam radiotherapy within the previous 4 weeks. Fifty-four patients were randomized to receive a single injection of 188 Re-HEDP, at doses of 30, 40 or 50 MBq/kg (interval, 12 weeks). Patients were followed-up by assessment of numerical rating scale (NRS) score, global quality of life (QOL) score and adverse events (AEs). ANOVA analysis, Chi-Squared test and LSD-t test were used in this study. RESULTS Significantly decreased NRS scores relative to baseline were observed in 40 MBq/kg group (Week 0 vs. Week 12: 6.0 ± 1.4 vs. 4.8 ± 2.5, P = 0.033) and 50 MBq/kg group (Week 0 vs. Week 12: 5.5 ± 1.5 vs. 4.5 ± 2.9, P = 0.046). Significant change of global QOL score from baseline was observed in 40 MBq/kg group at week 8 (global QOL score: P = 0.024, pain score: P = 0.041) and 50 MBq/kg group (pain score: P = 0.021) at week 12. No patients withdrew trial because of AEs in three groups. CONCLUSIONS 188 Re-HEDP at dose of 40 and 50 MBq/kg was generally effective to alleviate pain and improve QOL in lung cancer patients with painful bone metastases. 188 Re-HEDP was safe and well-tolerated.",2021,"Significant change of global QOL score from baseline was observed in 40 MBq/kg group at week 8 (global QOL score: P = 0.024, pain score: P = 0.041) and 50 MBq/kg group (pain score: P = 0.021) at week 12.","['lung cancer patients with bone metastases', 'enrolled patients with lung carcinoma and multifocal bone metastases and excluded patients who had received', 'patients with lung cancer and bone metastases', 'lung cancer patients with painful bone metastases', 'within the previous 4\xa0weeks', 'Fifty-four patients']","['188 Re-hydroxyethylidine diphosphonate (HEDP', 'single injection of 188 Re-HEDP', 'bisphosphonates or external-beam radiotherapy']","['numerical rating scale (NRS) score, global quality of life (QOL) score and adverse events (AEs', 'global QOL score', 'safe and well-tolerated', 'alleviate pain and improve QOL', 'Efficacy and safety', 'NRS scores']","[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0153690', 'cui_str': 'Secondary malignant neoplasm of bone'}, {'cui': 'C0684249', 'cui_str': 'Lung carcinoma'}, {'cui': 'C0205292', 'cui_str': 'Multifocal'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517807', 'cui_str': '54'}]","[{'cui': 'C1828331', 'cui_str': 'Rhenium-188'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonate'}, {'cui': 'C0086268', 'cui_str': 'Etidronate'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",54.0,0.138327,"Significant change of global QOL score from baseline was observed in 40 MBq/kg group at week 8 (global QOL score: P = 0.024, pain score: P = 0.041) and 50 MBq/kg group (pain score: P = 0.021) at week 12.","[{'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': ""Department of Nuclear Medicine, Huashan Hospital, Fudan University, Jing'an District, No.12 Urumchi Middle Road, Shanghai, 200040, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Nuclear Medicine, Huashan Hospital, Fudan University, Jing'an District, No.12 Urumchi Middle Road, Shanghai, 200040, China.""}, {'ForeName': 'Jicong', 'Initials': 'J', 'LastName': 'Gui', 'Affiliation': ""Department of Nuclear Medicine, Huashan Hospital, Fudan University, Jing'an District, No.12 Urumchi Middle Road, Shanghai, 200040, China.""}, {'ForeName': 'Congjin', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': ""Department of Nuclear Medicine, Huashan Hospital, Fudan University, Jing'an District, No.12 Urumchi Middle Road, Shanghai, 200040, China.""}, {'ForeName': 'Yuankai', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Nuclear Medicine, Huashan Hospital, Fudan University, Jing'an District, No.12 Urumchi Middle Road, Shanghai, 200040, China.""}, {'ForeName': 'Guangming', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': ""Department of Nuclear Medicine, Huashan Hospital, Fudan University, Jing'an District, No.12 Urumchi Middle Road, Shanghai, 200040, China.""}, {'ForeName': 'Dayu', 'Initials': 'D', 'LastName': 'Kuai', 'Affiliation': ""Department of Nuclear Medicine, Huashan Hospital, Fudan University, Jing'an District, No.12 Urumchi Middle Road, Shanghai, 200040, China.""}, {'ForeName': 'Yiwei', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Nuclear Medicine, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Zengli', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Nuclear Medicine, The Second Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Changjing', 'Initials': 'C', 'LastName': 'Zuo', 'Affiliation': 'Department of Nuclear Medicine, Shanghai Changhai Hospital, Navy Military Medical University, Shanghai, China.'}, {'ForeName': 'Zhongwei', 'Initials': 'Z', 'LastName': 'Lv', 'Affiliation': ""Department of Nuclear Medicine, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yingjian Biao', 'Initials': 'YB', 'LastName': 'ZhangLi', 'Affiliation': 'Department of Nuclear Medicine, Shanghai Cancer Center, Fudan University, Shanghai, China.'}, {'ForeName': 'Xingdang', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Nuclear Medicine, Huashan Hospital, Fudan University, Jing'an District, No.12 Urumchi Middle Road, Shanghai, 200040, China. xingdliu@fudan.edu.cn.""}]",International journal of clinical oncology,['10.1007/s10147-021-01906-y'] 4052,33847780,Striking a balance: outcomes of short-term Mono-J placement following ureterorenoscopy.,"To evaluate factors affecting the outcomes of short-term Mono-J insertion for 6 h following ureteroscopic stone removal. Patients treated with a Mono-J for 6 h after ureterorenoscopy and stone removal were analysed. FaST 1 and 2 (Fast Track Stent Studies), two consecutive single academic centre studies, were conducted between August 2014 and April 2018. In each study, we randomized patients with renal or ureteral calculi to two groups before ureterorenoscopy. FaST 1 compared a Mono-J insertion for 6 h versus Double-J insertion for 3-5 days after ureterorenoscopy. FaST 2 compared a Mono-J insertion to a tubeless procedure in the same clinical setting. All patients were pre-stented for 3-5 days before URS. The study endpoint was stent-related symptoms as assessed by a validated questionnaire (USSQ). Results were stratified by clinical parameters, stone characteristics and operation details. 108 of 156 initially randomized patients undergoing ureterorenoscopy were included. USSQ scores covering the time 3-5 weeks after stone removal showed a significantly reduced urinary symptoms and pain index compared to the scores before ureterorenoscopy. USSQ results before and after stone removal did not correlate with stone size or operation time and did not differ significantly depending on stone localization, the treating endourologist, or ureterorenoscopic device used (p > 0.05). Six patients (5%) required reintervention. Following secondary ureterorenoscopy and ureteral drainage with a Mono-J for 6 h, quality of life is independent of stone size and localization, operation time, the treating endourologist, and the URS device used.",2021,USSQ scores covering the time 3-5 weeks after stone removal showed a significantly reduced urinary symptoms and pain index compared to the scores before ureterorenoscopy.,"['patients with renal or ureteral calculi to two groups before ureterorenoscopy', '108 of 156 initially randomized patients undergoing ureterorenoscopy were included', 'two consecutive single academic centre studies, were conducted between August 2014 and April 2018']","['FaST 2 compared a Mono-J insertion', 'secondary ureterorenoscopy and ureteral drainage with a Mono-J', 'short-term Mono-J insertion', 'short-term Mono-J placement following ureterorenoscopy']","['urinary symptoms and pain index', 'USSQ scores', 'stone size or operation time', 'reintervention']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1270970', 'cui_str': 'Transurethral ureterorenoscopy'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1270970', 'cui_str': 'Transurethral ureterorenoscopy'}, {'cui': 'C1522613', 'cui_str': 'Ureteral route'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",156.0,0.0555305,USSQ scores covering the time 3-5 weeks after stone removal showed a significantly reduced urinary symptoms and pain index compared to the scores before ureterorenoscopy.,"[{'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Reicherz', 'Affiliation': 'Department of Urology, Marien Hospital, Ruhr-University Bochum, Hölkeskampring 40, 44625, Herne, Germany. alina.reicherz@elisabethgruppe.de.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Maas', 'Affiliation': 'Department of Urology, Augusta Medical Center Bochum, University of Witten/Herdecke, Bochum, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Reike', 'Affiliation': 'Department of Urology, Marien Hospital, Ruhr-University Bochum, Hölkeskampring 40, 44625, Herne, Germany.'}, {'ForeName': 'Mirco', 'Initials': 'M', 'LastName': 'Brehmer', 'Affiliation': 'Department of Urology, Marien Hospital, Ruhr-University Bochum, Hölkeskampring 40, 44625, Herne, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Noldus', 'Affiliation': 'Department of Urology, Marien Hospital, Ruhr-University Bochum, Hölkeskampring 40, 44625, Herne, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bach', 'Affiliation': 'Department of Urology, Marien Hospital, Ruhr-University Bochum, Hölkeskampring 40, 44625, Herne, Germany.'}]",Urolithiasis,['10.1007/s00240-021-01264-4'] 4053,33847047,Prospective ARNI versus ACE inhibitor trial to DetermIne Superiority in reducing heart failure Events after Myocardial Infarction (PARADISE-MI): Design and Baseline Characteristics.,"AIMS Patients surviving an acute myocardial infarction (AMI) are at risk of developing symptomatic heart failure (HF) or premature death. We hypothesized that sacubitril/valsartan, effective in the treatment of chronic HF, prevents development of HF and reduces cardiovascular death following high-risk AMI compared to a proven ACE inhibitor. This paper describes the study design and baseline characteristics of patients enrolled in the Prospective ARNI versus ACE inhibitor trial to DetermIne Superiority in reducing heart failure Events after Myocardial Infarction (PARADISE-MI) trial. METHODS AND RESULTS PARADISE-MI, a multinational (41 countries), double-blind, active-controlled trial, randomized patients within 0.5-7 days of presentation with index AMI to sacubitril/valsartan or ramipril. Transient pulmonary congestion and/or LVEF ≤ 40% and at least one additional factor augmenting risk of HF or death (age ≥70 years, eGFR <60ml/min/1.73m 2 , diabetes, prior MI, atrial fibrillation, LVEF <30%, Killip class ≥III, STEMI without reperfusion) were required for inclusion. PARADISE-MI was event-driven targeting 708 primary endpoints [cardiovascular (CV) death, HF hospitalization or outpatient development of HF]. Randomization of 5669 patients occurred 4.3 ± 1.8 days from presentation with index AMI. The mean age was 64 ± 12 years, 24% were women. The majority (76%) qualified with ST-segment elevation MI; acute percutaneous coronary intervention was performed in 88% and thrombolysis in 6%. LVEF was 37 ± 9% and 58% were Killip class ≥2. CONCLUSIONS Baseline therapies in PARADISE-MI reflect advances in contemporary evidence-based care. With enrollment complete PARADISE-MI is poised to determine whether sacubitril/valsartan is more effective than a proven ACE inhibitor in preventing development of HF and CV death following AMI.",2021,The majority (76%) qualified with ST-segment elevation MI; acute percutaneous coronary intervention was performed in 88% and thrombolysis in 6%.,"['Patients surviving an acute myocardial infarction (AMI', 'The mean age was 64 ±\u200912\u2009years, 24% were women']","['sacubitril/valsartan or ramipril', 'sacubitril/valsartan', 'LVEF']","['heart failure', 'HF and CV death', 'cardiovascular (CV) death, HF hospitalization or outpatient development of HF', 'cardiovascular death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0072973', 'cui_str': 'Ramipril'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}]","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",,0.223957,The majority (76%) qualified with ST-segment elevation MI; acute percutaneous coronary intervention was performed in 88% and thrombolysis in 6%.,"[{'ForeName': 'Karola S', 'Initials': 'KS', 'LastName': 'Jering', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, and Harvard Medical School Boston, MA, USA.""}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, and Harvard Medical School Boston, MA, USA.""}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Pfeffer', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, and Harvard Medical School Boston, MA, USA.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Granger', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Rigshospitalet, Blegdamsvej, Copenhagen, Denmark.'}, {'ForeName': 'Eldrin F', 'Initials': 'EF', 'LastName': 'Lewis', 'Affiliation': 'Division of Cardiovascular Medicine, Stanford University School of Medicine, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Aldo P', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': 'ANMCO Research Center, Florence, Italy.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Mann', 'Affiliation': 'Washington University Medical Center, St Louis, MO, USA.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, Scotland.'}, {'ForeName': 'Jean-Lucien', 'Initials': 'JL', 'LastName': 'Rouleau', 'Affiliation': 'Montréal Heart Institute, University of Montréal, Montréal, Quebec, Canada.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, and Harvard Medical School Boston, MA, USA.""}, {'ForeName': 'Philippe G', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'AP-HP (Assistance Publique-Hôpitaux de Paris), FACT (French Alliance for Cardiovascular Trials) and INSERM, Université de Paris, U-1148, Paris, France.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'van der Meer', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, University of Groningen, The Netherlands.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Wernsing', 'Affiliation': 'Novartis Pharmaceutical Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Carter', 'Affiliation': 'Novartis Pharmaceutical Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Weinong', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': 'Novartis Pharmaceutical Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Yinong', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Novartis Pharmaceutical Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lefkowitz', 'Affiliation': 'Novartis Pharmaceutical Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Jianjian', 'Initials': 'J', 'LastName': 'Gong', 'Affiliation': 'Novartis Pharmaceutical Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Novartis Pharmaceutical Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Bela', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Semmelweis University, Heart and Vascular Center, Budapest, Hungary.'}, {'ForeName': 'Stella M', 'Initials': 'SM', 'LastName': 'Macin', 'Affiliation': 'Instituto de Cardiología JF Cabral Corrientes, Argentina.'}, {'ForeName': 'Urmil', 'Initials': 'U', 'LastName': 'Shah', 'Affiliation': 'Care Institute of Medical Sciences, Ahmedabad, India.'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Instituto do Coracao, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, and Harvard Medical School Boston, MA, USA.""}]",European journal of heart failure,['10.1002/ejhf.2191'] 4054,33847018,Effect of different platelet rich fibrin matrices for ridge preservation in multiple tooth extractions: a split-mouth randomized controlled clinical trial.,"AIM To evaluate dimensional changes in the alveolar ridge and bone structure after tooth extraction when L-PRF or A-PRF+ were used in comparison to unassisted socket healing. MATERIALS AND METHODS Twenty patients in need of at least three tooth extractions in the aesthetic zone were included. L-PRF, A-PRF+ or control were randomly assigned, leaving one empty socket/edentulous site between conditions. CBCT scans were obtained immediately after tooth extraction and after 3 months of healing. Horizontal and vertical dimensional changes of the ridge and socket fill were calculated. Histological and micro-CT analysis of bone biopsies were used to evaluate post-surgical bone structural healing. RESULTS Mean horizontal and vertical changes at 1-mm below the crest (buccal and palatal side) were similar for the three sites (p>0.05). For the socket fill, L-PRF (85.2%) and A-PRF+ (83.8%) showed superior values than the control (67.9%). The histological and radiological analysis reported more newly formed bone for the PRF groups, without any significant differences between both. CONCLUSIONS PRF matrices failed to reduce the dimensional changes after multiple tooth extractions in the premaxilla. After 3-months healing, both PRF matrices showed radiographically a significant superiority for the socket fill. Histologically, they seemed to accelerate new bone formation.",2021,"The histological and radiological analysis reported more newly formed bone for the PRF groups, without any significant differences between both. ","['multiple tooth extractions', 'Twenty patients in need of at least three tooth extractions in the aesthetic zone were included']",['platelet rich fibrin matrices'],"['CBCT scans', 'Mean horizontal and vertical changes at 1-mm below the crest (buccal and palatal side']","[{'cui': 'C0204148', 'cui_str': 'Tooth extraction, multiple'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}]","[{'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439790', 'cui_str': 'Horizontal and vertical'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0206138', 'cui_str': 'CREST syndrome'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}]",20.0,0.0478661,"The histological and radiological analysis reported more newly formed bone for the PRF groups, without any significant differences between both. ","[{'ForeName': 'Ana B', 'Initials': 'AB', 'LastName': 'Castro', 'Affiliation': 'KU Leuven, Department of Oral Health Sciences, Section of Periodontology and Oral Microbiology &, University Hospitals Leuven Dentistry, Leuven, Belgium.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Van Dessel', 'Affiliation': 'KU Leuven, Department of Imaging and Pathology, OmfsImpath Research Group, Department of Oral and Maxillofacial Surgery, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Temmerman', 'Affiliation': 'KU Leuven, Department of Oral Health Sciences, Section of Periodontology and Oral Microbiology &, University Hospitals Leuven Dentistry, Leuven, Belgium.'}, {'ForeName': 'Reinhilde', 'Initials': 'R', 'LastName': 'Jacobs', 'Affiliation': 'KU Leuven, Department of Imaging and Pathology, OmfsImpath Research Group, Department of Oral and Maxillofacial Surgery, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Quirynen', 'Affiliation': 'KU Leuven, Department of Oral Health Sciences, Section of Periodontology and Oral Microbiology &, University Hospitals Leuven Dentistry, Leuven, Belgium.'}]",Journal of clinical periodontology,['10.1111/jcpe.13463'] 4055,33846983,Histopathology after lidocaine/prilocaine cream administration for vulvar biopsy.,"BACKGROUND Case series have described disruptive histopathologic changes following lidocaine/prilocaine cream anesthetic for biopsies. METHODS A study of histopathologic changes was performed following a randomized trial comparing topical lidocaine/prilocaine cream to 1% lidocaine injection anesthesia for vulvar biopsy. Histopathology was reviewed by two independent dermatopathologists blinded to the type of anesthetic. Specimens were scored on six histopathologic criteria described in the literature. Individual scores for each histopathologic feature and the total score across features were compared between the two groups using marginal models with generalized estimating equations. RESULTS Of 37 specimens reviewed, 19 were randomized to lidocaine/prilocaine cream and 18 to 1% lidocaine. Subjects exposed to lidocaine/prilocaine had the following odds of histopathologic changes, relative to lidocaine-exposed subjects: acantholysis (odds ratio 2.48; 95% confidence intervals 0.51, 12.06), clefting (2.42; 0.64, 9.14), pallor/necrosis (1.13; 0.28, 4.50), spongiosis (0.71; 0.18, 2.85), papillary dermal edema (1.17; 0.41, 3.29). Total scores were not significantly different between treatment arms (risk ratio 0.98; 0.71, 1.35). CONCLUSION This histopathologic analysis of a randomized trial between lidocaine/prilocaine cream and injected lidocaine as anesthesia for vulvar biopsy demonstrates the absence of significant disruptive histologic features secondary to the type of anesthetic. Additional studies in different clinical contexts are warranted. This article is protected by copyright. All rights reserved.",2021,"Total scores were not significantly different between treatment arms (risk ratio 0.98; 0.71, 1.35). ","['vulvar biopsy', 'Of 37 specimens reviewed']","['topical lidocaine/prilocaine cream', 'lidocaine/prilocaine cream', 'lidocaine/prilocaine cream and injected lidocaine', 'lidocaine/prilocaine cream anesthetic', 'lidocaine/prilocaine', 'lidocaine', 'lidocaine injection anesthesia']","['Total scores', 'histopathologic changes', 'pallor/necrosis', 'papillary dermal edema']","[{'cui': 'C0195060', 'cui_str': 'Biopsy of lesion of vulva'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0282443', 'cui_str': 'Review'}]","[{'cui': 'C0360097', 'cui_str': 'Lidocaine-containing product in cutaneous dose form'}, {'cui': 'C0033124', 'cui_str': 'Prilocaine'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0617623', 'cui_str': 'Lidocaine- and prilocaine-containing product'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C4049857', 'cui_str': 'Lidocaine Injection'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0677043', 'cui_str': 'Histopathology'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0030232', 'cui_str': 'Pale complexion'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0205312', 'cui_str': 'Papillary'}, {'cui': 'C0521464', 'cui_str': 'Edematous skin'}]",19.0,0.102457,"Total scores were not significantly different between treatment arms (risk ratio 0.98; 0.71, 1.35). ","[{'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Gonzalez', 'Affiliation': 'Division of Gynecologic Oncology, Duke University, Durham, NC.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Dunn', 'Affiliation': 'Department of Pathology, Duke University, Durham, NC.'}, {'ForeName': 'Logan', 'Initials': 'L', 'LastName': 'Williams', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University, Durham, NC.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Weber', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, NC.'}, {'ForeName': 'Alaattin', 'Initials': 'A', 'LastName': 'Erkanli', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, NC.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Havrilesky', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, NC.'}, {'ForeName': 'M Angelica', 'Initials': 'MA', 'LastName': 'Selim', 'Affiliation': 'Department of Pathology, Duke University, Durham, NC.'}]",Journal of cutaneous pathology,['10.1111/cup.14018'] 4056,33846971,"The CANBACK trial: a randomised, controlled clinical trial of oral cannabidiol for people presenting to the emergency department with acute low back pain.","OBJECTIVE To assess the analgesic efficacy and safety of single-dose oral cannabidiol (CBD) as an adjunct to standard care for patients presenting to an emergency department with acute low back pain. DESIGN Randomised, double blinded, placebo-controlled clinical trial. SETTING The tertiary emergency department of Austin Hospital, Melbourne. PARTICIPANTS Patients who presented with acute, non-traumatic low back pain between 21 May 2018 and 13 June 2019. INTERVENTION One hundred eligible patients were randomised to receiving 400 mg CBD or placebo in addition to standard emergency department analgesic medication. MAIN OUTCOME MEASURES Pain score two hours after administration of study agent, on a verbal numerical pain scale (range, 0-10). Secondary outcomes were length of stay, need for rescue analgesia, and adverse events. RESULTS The median age of the 100 participants was 47 years (IQR, 34-60 years); 44 were women. Mean pain scores at two hours were similar for the CBD (6.2 points; 95% CI, 5.5-6.9 points) and placebo groups (5.8 points; 95% CI, 5.1-6.6 points; absolute difference, -0.3 points; 95% CI, -1.3 to 0.6 points). The median length of stay was 9.0 hours (IQR, 7.4-12 hours) for the CBD group and 8.5 hours (IQR, 6.5-21 hours) for the placebo group. Oxycodone use during the four hours preceding and the four hours after receiving CBD or placebo was similar for the two groups, as were reported side effects. CONCLUSION CBD was not superior to placebo as an adjunct medication for relieving acute non-traumatic low back pain in the emergency department. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry, ACTRN12618000487213 (prospective).",2021,"CBD was not superior to placebo as an adjunct medication for relieving acute non-traumatic low back pain in the emergency department. ","['One hundred eligible patients', 'people presenting to the emergency department with acute low back pain', 'The tertiary emergency department of Austin Hospital, Melbourne.\nPARTICIPANTS\n\n\nPatients who presented with acute, non-traumatic low back pain between 21 May 2018 and 13 June 2019', 'patients presenting to an emergency department with acute low back pain', 'The median age of the 100 participants was 47 years (IQR, 34-60 years); 44 were women']","['oral cannabidiol', 'receiving 400\xa0mg CBD or placebo', 'Oxycodone', 'single-dose oral cannabidiol (CBD', 'placebo', 'CBD']","['Pain score', 'median length of stay', 'length of stay, need for rescue analgesia, and adverse events', 'verbal numerical pain scale', 'Mean pain scores', 'analgesic efficacy and safety']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0457950', 'cui_str': 'Acute low back pain'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0605411', 'cui_str': 'austin'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",100.0,0.781133,"CBD was not superior to placebo as an adjunct medication for relieving acute non-traumatic low back pain in the emergency department. ","[{'ForeName': 'Bronwyn', 'Initials': 'B', 'LastName': 'Bebee', 'Affiliation': 'Austin Health, Melbourne, VIC.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Taylor', 'Affiliation': 'Austin Health, Melbourne, VIC.'}, {'ForeName': 'Elyssia', 'Initials': 'E', 'LastName': 'Bourke', 'Affiliation': 'Austin Health, Melbourne, VIC.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Pollack', 'Affiliation': 'Austin Health, Melbourne, VIC.'}, {'ForeName': 'Lian', 'Initials': 'L', 'LastName': 'Foster', 'Affiliation': 'Austin Health, Melbourne, VIC.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ching', 'Affiliation': 'Austin Health, Melbourne, VIC.'}, {'ForeName': 'Anselm', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Austin Health, Melbourne, VIC.'}]",The Medical journal of Australia,['10.5694/mja2.51014'] 4057,33846544,Correction to: FLT3 inhibitor lestaurtinib plus chemotherapy for newly diagnosed KMT2A-rearranged infant acute lymphoblastic leukemia: Children's Oncology Group trial AALL0631.,,2021,,['newly diagnosed KMT2A-rearranged infant acute lymphoblastic leukemia'],['FLT3 inhibitor lestaurtinib plus chemotherapy'],[],"[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1527868', 'cui_str': 'MLL protein, human'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}]","[{'cui': 'C0251006', 'cui_str': 'FLT3 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1541677', 'cui_str': 'lestaurtinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.154267,,"[{'ForeName': 'Patrick A', 'Initials': 'PA', 'LastName': 'Brown', 'Affiliation': 'Division of Pediatric Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA. pbrown2@jhmi.edu.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Kairalla', 'Affiliation': 'Department of Biostatistics, Colleges of Medicine, Public Health & Health Professions, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'Hilden', 'Affiliation': ""Center for Cancer and Blood Disorders, Children's Hospital Colorado, Aurora, CO, USA.""}, {'ForeName': 'ZoAnn E', 'Initials': 'ZE', 'LastName': 'Dreyer', 'Affiliation': ""Texas Children's Hospital, Houston, TX, USA.""}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Carroll', 'Affiliation': 'Department of Genetics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Nyla A', 'Initials': 'NA', 'LastName': 'Heerema', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, OH, USA.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Colleges of Medicine, Public Health & Health Professions, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Devidas', 'Affiliation': ""Department of Global Pediatric Medicine, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Lia', 'Initials': 'L', 'LastName': 'Gore', 'Affiliation': ""Center for Cancer and Blood Disorders, Children's Hospital Colorado, Aurora, CO, USA.""}, {'ForeName': 'Wanda L', 'Initials': 'WL', 'LastName': 'Salzer', 'Affiliation': 'U.S. Army Medical Research and Materiel Command, Fort Detrick, MD, USA.'}, {'ForeName': 'Naomi J', 'Initials': 'NJ', 'LastName': 'Winick', 'Affiliation': 'Division of Pediatric Hematology/Oncology, University of Texas Southwestern School of Medicine, Dallas, TX, USA.'}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Carroll', 'Affiliation': 'Department of Pediatrics and Perlmutter Cancer Center, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Raetz', 'Affiliation': 'Department of Pediatrics and Perlmutter Cancer Center, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Borowitz', 'Affiliation': 'Departments of Pathology and Oncology, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Small', 'Affiliation': 'Division of Pediatric Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Mignon L', 'Initials': 'ML', 'LastName': 'Loh', 'Affiliation': ""Department of Pediatrics, Benioff Children's Hospital and the Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA, USA.""}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Hunger', 'Affiliation': ""Department of Pediatrics and the Center for Childhood Cancer Research, Children's Hospital of Philadelphia and the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.""}]",Leukemia,['10.1038/s41375-021-01245-x'] 4058,33846516,The effect of resistance training set configuration on strength and muscular performance adaptations in male powerlifters.,"The purpose of this study was to determine the effects of different set configurations on strength and muscular performance adaptations after an 8-week resistance training program. Twenty-four male powerlifters participated in this study and were randomly assigned to one of two resistance training groups: (1) cluster sets (CS: n = 8), (2), traditional sets (TS: n = 8), and a control group (CG: n = 8). All powerlifters were evaluated for thigh and arm circumference, upper and lower body impulsive activities, and 1 repetition maximum (1RM) in the back squat, bench press, and deadlift prior to and after the 8-week training intervention. After training, both the CS and TS groups increased arm and thigh circumferences and decreased body fat. The CS group resulted in greater increases in upper and lower body impulsive activities than the TS group, respectively. In addition, the CS and TS groups indicated similar changes in 1RM bench press, back squat, and deadlift following the 8 weeks training intervention. These results suggest that cluster sets induce adaptive changes that favor impulsive activities in powerlifters.",2021,"The CS group resulted in greater increases in upper and lower body impulsive activities than the TS group, respectively.","['male powerlifters', 'Twenty-four male powerlifters']",['resistance training set configuration'],"['upper and lower body impulsive activities', 'strength and muscular performance adaptations', '1RM bench press, back squat, and deadlift', 'thigh and arm circumference, upper and lower body impulsive activities, and 1 repetition maximum (1RM', 'thigh circumferences and decreased body fat']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3715070', 'cui_str': '24'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0449830', 'cui_str': 'With configuration'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}]",24.0,0.0043638,"The CS group resulted in greater increases in upper and lower body impulsive activities than the TS group, respectively.","[{'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Arazi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, University of Guilan, P.O. Box 41635-1438, Rasht, Iran. hamidarazi@yahoo.com.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Khoshnoud', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, University of Guilan, P.O. Box 41635-1438, Rasht, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Asadi', 'Affiliation': 'Department of Physical Education and Sport Sciences, Payame Noor University, Tehran, Iran.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Tufano', 'Affiliation': 'Faculty of Physical Education and Sport, Charles University, Prague, Czechia.'}]",Scientific reports,['10.1038/s41598-021-87372-y'] 4059,33846503,Side effects of the metacognitive training for depression compared to a cognitive remediation training in patients with depression.,"Although awareness of side effects over the course of psychotherapy is growing, side effects are still not always reported. The purpose of the present study was to examine side effects in a randomized controlled trial comparing Metacognitive Training for Depression (D-MCT) and a cognitive remediation training in patients with depression. 84 patients were randomized to receive either D-MCT or cognitive remediation training (MyBrainTraining) for 8 weeks. Side effects were assessed after the completion of each intervention (post) using the Short Inventory of the Assessment of Negative Effects (SIAN) and again 6 months later (follow-up) using the Negative Effects Questionnaire (NEQ). D-MCT and MyBrainTraining did not differ significantly in the number of side effects. At post assessment, 50% of the D-MCT group and 59% of the MyBrainTraining group reported at least one side effect in the SIAN. The most frequently reported side effect was disappointment in subjective benefit of study treatment. At follow-up, 52% reported at least one side effect related to MyBrainTraining, while 34% reported at least one side effect related to the D-MCT in the NEQ. The most frequently reported side effects fell into the categories of ""symptoms"" and ""quality"". Our NEQ version was missing one item due to a technical error. Also, allegiance effects should be considered. The sample size resulted in low statistical power. The relatively tolerable number of side effects suggests D-MCT and MyBrainTraining are safe and well-received treatment options for people with depression. Future studies should also measure negative effects to corroborate our results.",2021,Side effects were assessed after the completion of each intervention (post) using the Short Inventory of the Assessment of Negative Effects (SIAN) and again 6 months later (follow-up) using the Negative Effects Questionnaire (NEQ).,"['patients with depression', 'people with depression', '84 patients']","['Metacognitive Training', 'metacognitive training', 'D-MCT or cognitive remediation training (MyBrainTraining', 'cognitive remediation training']","['number of side effects', 'Side effects', 'Negative Effects Questionnaire (NEQ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0026687', 'cui_str': 'Mucociliary clearance'}, {'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",84.0,0.0140205,Side effects were assessed after the completion of each intervention (post) using the Short Inventory of the Assessment of Negative Effects (SIAN) and again 6 months later (follow-up) using the Negative Effects Questionnaire (NEQ).,"[{'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Dietrichkeit', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. m.dietrichkeit@uke.de.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Hagemann-Goebel', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Asklepios Clinic North, Hamburg, Germany.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Nestoriuc', 'Affiliation': 'Institute of Systems Neuroscience, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Jelinek', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",Scientific reports,['10.1038/s41598-021-87198-8'] 4060,33846498,Effects of interleukin-1 antagonism and corticosteroids on fibroblast growth factor-21 in patients with metabolic syndrome.,"Fibroblast growth factor-21 (FGF21) is elevated in patients with the metabolic syndrome. Although the exact underlying mechanisms remain ill-defined, chronic low-grade inflammation with increased Interleukin-(IL)-1β expression may be responsible. The aim of this study was to investigate effects of two different anti-inflammatory treatments (IL-1 antagonism or high-dose corticosteroids) on FGF21 in patients with the metabolic syndrome. This is a secondary analysis of two interventional studies in patients with obesity and features of the metabolic syndrome. Trial A was an interventional trial (n = 73) investigating short-term effects of the IL-1 antagonist anakinra and of dexamethasone. Trial B was a randomized, placebo-controlled, double-blinded trial (n = 67) investigating longer-term effects of IL-1 antagonism. In total, 140 patients were included in both trials. Median age was 55 years (IQR 44-66), 26% were female and median BMI was 37 kg/m 2 (IQR 34-39). Almost half of the patients were diabetic (45%) and had increased c-reactive protein levels of 3.4 mg/L. FGF21 levels correlated with fasting glucose levels, HOMA-index, C-peptide levels, HbA1c and BMI. Short-term treatment with anakinra led to a reduction of FGF21 levels by - 200 pg/mL (95%CI - 334 to - 66; p = 0.004). No effect was detectable after longer-term treatment (between-group difference: - 8.8 pg/mL (95%CI - 130.9 to 113.3; p = 0.89). Acute treatment with dexamethasone was associated with reductions of FGF21 by -175 pg/mL (95%CI - 236 to - 113; p < 0.001). Anti-inflammatory treatment with both, IL-1 antagonism and corticosteroids reduced FGF21 levels at short-term in individuals with the metabolic syndrome.Trial registration: ClinicalTrials.gov Identifiers NCT02672592 and NCT00757276.",2021,Acute treatment with dexamethasone was associated with reductions of FGF21 by -175 ,"['patients with obesity and features of the metabolic syndrome', '140 patients were included in both trials', 'patients with the metabolic syndrome', 'individuals with the metabolic syndrome', 'Median age was 55\xa0years (IQR 44-66), 26% were female and median BMI was 37\xa0kg/m 2 (IQR 34-39', 'patients with metabolic syndrome']","['dexamethasone', 'IL-1 antagonist anakinra and of dexamethasone', 'IL-1 antagonism', 'Fibroblast growth', 'anti-inflammatory treatments (IL-1 antagonism or high-dose corticosteroids', 'placebo', 'interleukin-1 antagonism and corticosteroids', 'IL-1 antagonism and corticosteroids']","['fasting glucose levels, HOMA-index, C-peptide levels, HbA1c and BMI', 'c-reactive protein levels', 'fibroblast growth factor-21', 'FGF21 levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}, {'cui': 'C0016030', 'cui_str': 'Fibroblast'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0202100', 'cui_str': 'Insulin C-peptide measurement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",140.0,0.443868,Acute treatment with dexamethasone was associated with reductions of FGF21 by -175 ,"[{'ForeName': 'Fahim', 'Initials': 'F', 'LastName': 'Ebrahimi', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, University Hospital Basel, Basel, Switzerland. f.ebrahimi@outlook.com.'}, {'ForeName': 'Sandrine Andrea', 'Initials': 'SA', 'LastName': 'Urwyler', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Matthias Johannes', 'Initials': 'MJ', 'LastName': 'Betz', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Emanuel Remigius', 'Initials': 'ER', 'LastName': 'Christ', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Schuetz', 'Affiliation': 'Department of Clinical Research, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Mueller', 'Affiliation': 'Department of Clinical Research, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Marc Yves', 'Initials': 'MY', 'LastName': 'Donath', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Christ-Crain', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, University Hospital Basel, Basel, Switzerland.'}]",Scientific reports,['10.1038/s41598-021-87207-w'] 4061,33863751,Type 2 Diabetes Subtype Responsive to ACCORD Intensive Glycemia Treatment.,"OBJECTIVE Current type 2 diabetes (T2D) management contraindicates intensive glycemia treatment in patients with high cardiovascular disease (CVD) risk and is partially motivated by evidence of harms in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Heterogeneity in response to intensive glycemia treatment has been observed, suggesting potential benefit for some individuals. RESEARCH DESIGN AND METHODS ACCORD was a randomized controlled trial that investigated whether intensively treating glycemia in individuals with T2D would reduce CVD outcomes. Using a novel approach to cluster HbA 1c trajectories, we identified groups in the intensive glycemia arm with modified CVD risk. Genome-wide analysis and polygenic score (PS) were developed to predict group membership. Mendelian randomization was performed to infer causality. RESULTS We identified four clinical groupings in the intensive glycemia arm, and clinical group 4 (C4) displayed fewer CVD (hazard ratio [HR] 0.34; P = 2.01 × 10 -3 ) and microvascular outcomes (HR 0.86; P = 0.015) than those receiving standard treatment. A single-nucleotide polymorphism, rs220721, in MAS1 reached suggestive significance in C4 ( P = 4.34 × 10 -7 ). PS predicted C4 with high accuracy (area under the receiver operating characteristic curve 0.98), and this predicted C4 displayed reduced CVD risk with intensive versus standard glycemia treatment (HR 0.53; P = 4.02 × 10 -6 ), but not reduced risk of microvascular outcomes ( P < 0.05). Mendelian randomization indicated causality between PS, on-trial HbA 1c , and reduction in CVD outcomes ( P < 0.05). CONCLUSIONS We found evidence of a T2D clinical group in ACCORD that benefited from intensive glycemia treatment, and membership in this group could be predicted using genetic variants. This study generates new hypotheses with implications for precision medicine in T2D and represents an important development in this landmark clinical trial warranting further investigation.",2021,"A single-nucleotide polymorphism, rs220721, in MAS1 reached suggestive significance in C4 ( P = 4.34 × 10 -7 ).","['individuals with T2D would reduce CVD outcomes', 'patients with high cardiovascular disease (CVD) risk']",['Current type 2 diabetes (T2D) management contraindicates intensive glycemia treatment'],"['CVD risk', 'microvascular outcomes', 'Genome-wide analysis and polygenic score (PS', 'CVD outcomes', 'risk of microvascular outcomes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.139569,"A single-nucleotide polymorphism, rs220721, in MAS1 reached suggestive significance in C4 ( P = 4.34 × 10 -7 ).","[{'ForeName': 'Arshiya', 'Initials': 'A', 'LastName': 'Mariam', 'Affiliation': 'Department of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Galen', 'Initials': 'G', 'LastName': 'Miller-Atkins', 'Affiliation': 'Department of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Pantalone', 'Affiliation': 'Endocrinology and Metabolism Institute, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Zimmerman', 'Affiliation': 'Endocrinology and Metabolism Institute, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Barnard', 'Affiliation': 'Department of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Kattan', 'Affiliation': 'Department of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Hetal', 'Initials': 'H', 'LastName': 'Shah', 'Affiliation': 'Joslin Diabetes Center and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Howard L', 'Initials': 'HL', 'LastName': 'McLeod', 'Affiliation': 'Taneja College of Pharmacy, University of South Florida, Tampa, FL.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Doria', 'Affiliation': 'Joslin Diabetes Center and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Wagner', 'Affiliation': 'Center for Pharmacogenomics and Individualized Therapy, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'Division of Endocrinology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Alison A', 'Initials': 'AA', 'LastName': 'Motsinger-Reif', 'Affiliation': 'Biostatistics and Computational Biology Branch, National Institute of Environmental Health Sciences, Research Triangle Park, NC.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Rotroff', 'Affiliation': 'Department of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, OH rotrofd@ccf.org.'}]",Diabetes care,['10.2337/dc20-2700'] 4062,33863716,Therapy adjustments in people with type 1 diabetes with impaired hypoglycemia awareness on multiple daily injections using real-time continuous glucose monitoring: a mechanistic analysis of the HypoDE study.,"INTRODUCTION Studies have shown beneficial effects of real-time continuous glucose monitoring (rtCGM) usage on clinical outcomes. The objective of this analysis was to identify which therapy adjustments were made by people with type 1 diabetes with impaired hypoglycemia awareness during rtCGM usage enabling reductions in the number of low glucose events observed in the HypoDE (Hypoglycemia in Deutschland) study. RESEARCH DESIGN AND METHODS In the multicenter randomized controlled trial in people with type 1 diabetes on multiple daily injections with impaired hypoglycemia awareness, participants recorded their diabetes therapy in 7-day logbooks at baseline and at 6-month follow-up. They used rtCGM or self-monitoring of blood glucose for therapy adjustments. This mechanistic analysis looked at changes in various aspects of therapy. RESULTS Logbooks were completed by 70 participants in the rtCGM group and 65 participants in the control group. Participants in the rtCGM group kept their total carbohydrate consumption, daily insulin doses and distribution constant during the study. However, they reported an increased intake of rescue carbohydrates (0.8±0.6 (mean±SD) vs 1.0±0.8 intake/day; baseline-adjusted between-group difference 0.3 intake (0.1-0.5), p=0.031). The glucose threshold at which rescue carbohydrate intake was initiated was elevated from 71±13 mg/dL (3.9±0.7 mmol/L) to 79±14 mg/dL (4.4±0.8 mmol/L) (adjusted between-group difference +7.6 mg/dL (2.4-12.8) (+0.4 mmol/L (0.1-0.7)); p=0.005) in the rtCGM group. Regression analysis showed that follow-up low glucose events were associated with group allocation (p<0.001), low glucose events at baseline (p=0.016) and rescue threshold (p=0.001). CONCLUSIONS No major adjustments in insulin therapy were made by study participants with impaired hypoglycemia awareness; however, they were more active in preventing hypoglycemia by taking rescue carbohydrates earlier and more often. TRIAL REGISTRATION NUMBER NCT02671968.",2021,"Regression analysis showed that follow-up low glucose events were associated with group allocation (p<0.001), low glucose events at baseline (p=0.016) and rescue threshold (p=0.001). ","['participants with impaired hypoglycemia awareness', 'people with type 1 diabetes with impaired hypoglycemia awareness during rtCGM usage enabling reductions in the number of low glucose events observed in the HypoDE (Hypoglycemia in Deutschland) study', '70 participants in the rtCGM group and 65 participants in the control group', 'people with type 1 diabetes on multiple daily injections with impaired hypoglycemia awareness, participants recorded their diabetes therapy in 7-day logbooks at baseline and at 6-month follow-up', 'people with type 1 diabetes with impaired hypoglycemia awareness']","['rtCGM', 'real-time continuous glucose monitoring']","['glucose threshold at which rescue carbohydrate intake', 'intake of rescue carbohydrates', 'total carbohydrate consumption, daily insulin doses and distribution constant', 'low glucose events']","[{'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0860801', 'cui_str': 'Glucose low'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0860801', 'cui_str': 'Glucose low'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.131114,"Regression analysis showed that follow-up low glucose events were associated with group allocation (p<0.001), low glucose events at baseline (p=0.016) and rescue threshold (p=0.001). ","[{'ForeName': 'Delia', 'Initials': 'D', 'LastName': 'Waldenmaier', 'Affiliation': 'Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany delia.waldenmaier@idt-ulm.de.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Freckmann', 'Affiliation': 'Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Pleus', 'Affiliation': 'Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Hermanns', 'Affiliation': 'Research Institute of the Diabetes Academy Mergentheim, Bad Mergentheim, Germany.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Ehrmann', 'Affiliation': 'Research Institute of the Diabetes Academy Mergentheim, Bad Mergentheim, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Heinemann', 'Affiliation': 'Science-Consulting in Diabetes, Neuss, Germany.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Haug', 'Affiliation': 'Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2020-001848'] 4063,33863665,Pulmonary Artery Proportional Pulse Pressure (PAPP) Index Identifies Patients With Improved Survival From the CardioMEMS Implantable Pulmonary Artery Pressure Monitor.,"BACKGROUND Pulmonary artery proportional pulse pressure (PAPP) was recently shown to have prognostic value in heart failure (HF) with reduced ejection fraction (HFrEF) and pulmonary hypertension. We tested the hypothesis that PAPP would be predictive of adverse outcomes in patients with implantable pulmonary artery pressure monitor (CardioMEMS™ HF System, St. Jude Medical [now Abbott], Atlanta, GA, USA). METHODS Survival analysis with Cox proportional hazards regression was used to evaluate all-cause deaths and HF hospitalisation (HFH) in CHAMPION trial 1 patients who received treatment with the CardioMEMS device based on the PAPP. RESULTS Among 550 randomised patients, 274 had PAPP ≤ the median value of 0.583 while 276 had PAPP>0.583. Patients with PAPP≤0.583 (versus PAPP>0.583) had an increased risk of HFH (HR 1.40, 95% CI 1.16-1.68, p=0.0004) and experienced a significant 46% reduction in annualised risk of death with CardioMEMS treatment (HR 0.54, 95% CI 0.31-0.92) during 2-3 years of follow-up. This survival benefit was attributable to the treatment benefit in patients with HFrEF and PAPP≤0.583 (HR 0.50, 95% CI 0.28-0.90, p<0.05). Patients with PAPP>0.583 or HF with preserved EF (HFpEF) had no significant survival benefit with treatment (p>0.05). CONCLUSION Lower PAPP in HFrEF patients with CardioMEMS constitutes a higher mortality risk status. More studies are needed to understand clinical applications of PAPP in implantable pulmonary artery pressure monitors.",2021,"Patients with PAPP≤0.583 (versus PAPP>0.583) had an increased risk of HFH (HR 1.40, 95% CI 1.16-1.68, p=0.0004) and experienced a significant 46% reduction in annualised risk of death with CardioMEMS treatment (HR 0.54, 95% CI 0.31-0.92) during 2-3 years of follow-up.","['patients with implantable pulmonary artery pressure monitor (CardioMEMS™ HF System, St. Jude Medical [now Abbott], Atlanta, GA, USA', 'patients who received treatment with the CardioMEMS device based on the PAPP', 'HFrEF patients with', '550 randomised patients, 274 had PAPP ≤ the median value of 0.583 while 276 had PAPP>0.583']","['PAPP', 'PAPP>0.583 or HF with preserved EF (HFpEF', 'CardioMEMS', 'Pulmonary artery proportional pulse pressure (PAPP']","['risk of HFH', 'survival benefit', 'annualised risk of death', 'Pulmonary Artery Proportional Pulse Pressure (PAPP', 'Survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205351', 'cui_str': 'Proportional'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C3844103', 'cui_str': '550'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}]","[{'cui': 'C0205351', 'cui_str': 'Proportional'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0034052', 'cui_str': 'Pulmonary artery structure'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0034052', 'cui_str': 'Pulmonary artery structure'}, {'cui': 'C0205351', 'cui_str': 'Proportional'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}]",550.0,0.1863,"Patients with PAPP≤0.583 (versus PAPP>0.583) had an increased risk of HFH (HR 1.40, 95% CI 1.16-1.68, p=0.0004) and experienced a significant 46% reduction in annualised risk of death with CardioMEMS treatment (HR 0.54, 95% CI 0.31-0.92) during 2-3 years of follow-up.","[{'ForeName': 'Sula', 'Initials': 'S', 'LastName': 'Mazimba', 'Affiliation': 'University of Virginia Health System, Charlottesville, USA. Electronic address: SM8SD@hscmail.mcc.virginia.edu.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Ginn', 'Affiliation': 'Global Research and Development, St. Jude Medical, Sylmar, USA.'}, {'ForeName': 'Hunter', 'Initials': 'H', 'LastName': 'Mwansa', 'Affiliation': 'Case Western Reserve University/St Vincent Charity Medical Center, Cleveland, USA.'}, {'ForeName': 'Olusola', 'Initials': 'O', 'LastName': 'Laja', 'Affiliation': 'University of Virginia Health System, Charlottesville, USA.'}, {'ForeName': 'Christiana', 'Initials': 'C', 'LastName': 'Jeukeng', 'Affiliation': 'University of Virginia Health System, Charlottesville, USA.'}, {'ForeName': 'Comfort', 'Initials': 'C', 'LastName': 'Elumogo', 'Affiliation': 'University of Virginia Health System, Charlottesville, USA.'}, {'ForeName': 'Brandy', 'Initials': 'B', 'LastName': 'Patterson', 'Affiliation': 'University of Virginia Health System, Charlottesville, USA.'}, {'ForeName': 'Jamie L W', 'Initials': 'JLW', 'LastName': 'Kennedy', 'Affiliation': 'University of Virginia Health System, Charlottesville, USA.'}, {'ForeName': 'Nishaki', 'Initials': 'N', 'LastName': 'Mehta', 'Affiliation': 'University of Virginia Health System, Charlottesville, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Hossack', 'Affiliation': 'Department of Biomedical, Electrical and Computer Engineering, University of Virginia Health System, Charlottesville, USA.'}, {'ForeName': 'Alex M', 'Initials': 'AM', 'LastName': 'Parker', 'Affiliation': 'University of Virginia Health System, Charlottesville, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Mihalek', 'Affiliation': 'University of Virginia Health System, Charlottesville, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Tallaj', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, USA.'}, {'ForeName': 'Nishtha', 'Initials': 'N', 'LastName': 'Sodhi', 'Affiliation': 'University of Virginia Health System, Charlottesville, USA.'}, {'ForeName': 'Younghoon', 'Initials': 'Y', 'LastName': 'Kwon', 'Affiliation': 'University of Washington Medical Center, Seattle, USA.'}, {'ForeName': 'Salpy V', 'Initials': 'SV', 'LastName': 'Pamboukian', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, USA.'}, {'ForeName': 'Philip B', 'Initials': 'PB', 'LastName': 'Adamson', 'Affiliation': 'Global Research and Development, St. Jude Medical, Sylmar, USA.'}, {'ForeName': 'Kenneth C', 'Initials': 'KC', 'LastName': 'Bilchick', 'Affiliation': 'University of Virginia Health System, Charlottesville, USA.'}]","Heart, lung & circulation",['10.1016/j.hlc.2021.03.004'] 4064,33846875,Web-based cognitive behavior therapy for chronic pain patients with aberrant drug-related behavior: How did it work and for whom?,"This study explored mediating pathways, moderating factors, and moderated mediation effects of a web-based, cognitive behavioral therapy (CBT) intervention for chronic pain patients with aberrant drug-related behavior (ADRB). In a 2-arm RCT, patients with chronic pain who screened positive for ADRB received treatment-as-usual (TAU, n = 55) or TAU plus a 12-week, web-based CBT intervention (n = 55). Assessments were conducted at weeks 4, 8, and 12, and at 1- and 3-months post intervention. Web-CBT significantly reduced pain catastrophizing, which, in turn, reduced pain interference and pain severity via a pathway of pain catastrophizing. Web-CBT also significantly reduced ADRB both directly and indirectly by reducing pain catastrophizing. For pain interference and pain severity, web-CBT was more effective than TAU for younger patients (≤ age 50). For pain severity, web-CBT was more effective for both younger patients (≤ age 50), and those with a lifetime substance use disorder. Findings suggest that web-CBT's positive impact on pain outcomes and ADRB are mediated by its effect on pain catastrophizing, and its treatment effects may be most robust for younger patients and those with histories of substance dependence.",2021,"For pain interference and pain severity, web-CBT was more effective than TAU for younger patients (≤ age 50).","['patients with chronic pain who screened positive for ADRB', 'younger patients and those\xa0with histories of substance dependence', 'chronic pain patients with aberrant drug-related behavior (ADRB', 'chronic pain patients with aberrant drug-related behavior']","['TAU plus a 12-week, web-based CBT intervention', 'cognitive behavioral therapy (CBT) intervention', 'Web-based cognitive behavior therapy']","['pain outcomes and ADRB', 'pain interference and pain severity', 'pain catastrophizing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0038580', 'cui_str': 'Substance dependence'}]","[{'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}]",,0.0148385,"For pain interference and pain severity, web-CBT was more effective than TAU for younger patients (≤ age 50).","[{'ForeName': 'Haiyi', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Department of Biomedical Data Science, Geisel School of Medicine at Dartmouth College, Hanover, NH, USA. Haiyi.Xie@dartmouth.edu.'}, {'ForeName': 'Honoria', 'Initials': 'H', 'LastName': 'Guarino', 'Affiliation': 'Graduate School of Public Health and Health Policy, City University of New York, New York, NY, USA.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Moore', 'Affiliation': 'Center for Technology and Behavioral Health, Geisel School of Medicine at Dartmouth College, Lebanon, NH, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Acosta', 'Affiliation': 'Graduate School of Public Health and Health Policy, City University of New York, New York, NY, USA.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Budney', 'Affiliation': 'Department of Psychiatry, Geisel School of Medicine at Dartmouth College, Hanover, NH, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Rosenblum', 'Affiliation': 'NDRI-USA, New York, NY, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Marsch', 'Affiliation': 'Department of Psychiatry, Geisel School of Medicine at Dartmouth College, Hanover, NH, USA.'}, {'ForeName': 'Chunki', 'Initials': 'C', 'LastName': 'Fong', 'Affiliation': 'Graduate School of Public Health and Health Policy, City University of New York, New York, NY, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-021-00219-9'] 4065,33846866,Nalmefene attenuates neural alcohol cue-reactivity in the ventral striatum and subjective alcohol craving in patients with alcohol use disorder.,"RATIONALE Alcohol use disorder is a common and devastating mental illness for which satisfactory treatments are still lacking. Nalmefene, as an opioid receptor modulator, could pharmacologically support the reduction of drinking by reducing the (anticipated) rewarding effects of alcohol and expanding the range of treatment options. It has been hypothesized that nalmefene acts via an indirect modulation of the mesolimbic reward system. So far, only a few imaging findings on the neuronal response to nalmefene are available. OBJECTIVES We tested the effect of a single dose of 18 mg nalmefene on neuronal cue-reactivity in the ventral and dorsal striatum and subjective craving. METHODS Eighteen non-treatment-seeking participants with alcohol use disorder (67% male, M = 50.3 ± 13.9 years) with a current high-risk drinking level (M = 76.9 ± 52 g of pure alcohol per day) were investigated using a cue-reactivity task during functional magnetic resonance imaging (fMRI) in a double-blind, placebo-controlled, cross-over study/design. In addition, self-reported craving was assessed before and after exposure to alcohol cues. RESULTS An a priori defined region of interest (ROI) analysis of fMRI data from 15 participants revealed that nalmefene reduced alcohol cue-reactivity in the ventral, but not the dorsal striatum. Additionally, the subjective craving was significantly reduced after the cue-reactivity task under nalmefene compared to placebo. CONCLUSION In the present study, reduced craving and cue-reactivity to alcohol stimuli in the ventral striatum by nalmefene indicates a potential anti-craving effect of this drug via attenuation of neural alcohol cue-reactivity.",2021,"Additionally, the subjective craving was significantly reduced after the cue-reactivity task under nalmefene compared to placebo. ","['patients with alcohol use disorder', 'Eighteen non-treatment-seeking participants with alcohol use disorder (67% male, M = 50.3 ± 13.9 years) with a current high-risk drinking level (M = 76.9 ± 52 g of pure alcohol per day']","['Nalmefene', 'cue-reactivity task during functional magnetic resonance imaging (fMRI']","['subjective craving', 'neuronal cue-reactivity', 'alcohol cue-reactivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517562', 'cui_str': '13.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0439505', 'cui_str': '/day'}]","[{'cui': 'C0068377', 'cui_str': 'nalmefene'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]",,0.060637,"Additionally, the subjective craving was significantly reduced after the cue-reactivity task under nalmefene compared to placebo. ","[{'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Karl', 'Affiliation': 'Department of Addictive Behaviour and Addiction Medicine, Central Institute of Mental Health, University of Heidelberg, Medical Faculty Mannheim, Mannheim, Germany.'}, {'ForeName': 'J Malte', 'Initials': 'JM', 'LastName': 'Bumb', 'Affiliation': 'Department of Addictive Behaviour and Addiction Medicine, Central Institute of Mental Health, University of Heidelberg, Medical Faculty Mannheim, Mannheim, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Bach', 'Affiliation': 'Department of Addictive Behaviour and Addiction Medicine, Central Institute of Mental Health, University of Heidelberg, Medical Faculty Mannheim, Mannheim, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Dinter', 'Affiliation': 'Department of Addictive Behaviour and Addiction Medicine, Central Institute of Mental Health, University of Heidelberg, Medical Faculty Mannheim, Mannheim, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Koopmann', 'Affiliation': 'Department of Addictive Behaviour and Addiction Medicine, Central Institute of Mental Health, University of Heidelberg, Medical Faculty Mannheim, Mannheim, Germany.'}, {'ForeName': 'Derik', 'Initials': 'D', 'LastName': 'Hermann', 'Affiliation': 'Department of Addictive Behaviour and Addiction Medicine, Central Institute of Mental Health, University of Heidelberg, Medical Faculty Mannheim, Mannheim, Germany.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Mann', 'Affiliation': 'Department of Addictive Behaviour and Addiction Medicine, Central Institute of Mental Health, University of Heidelberg, Medical Faculty Mannheim, Mannheim, Germany.'}, {'ForeName': 'Falk', 'Initials': 'F', 'LastName': 'Kiefer', 'Affiliation': 'Department of Addictive Behaviour and Addiction Medicine, Central Institute of Mental Health, University of Heidelberg, Medical Faculty Mannheim, Mannheim, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Vollstädt-Klein', 'Affiliation': 'Department of Addictive Behaviour and Addiction Medicine, Central Institute of Mental Health, University of Heidelberg, Medical Faculty Mannheim, Mannheim, Germany. s.vollstaedt-klein@zi-mannheim.de.'}]",Psychopharmacology,['10.1007/s00213-021-05842-7'] 4066,33846735,Effectiveness of a school-based randomized controlled trial aimed at increasing physical activity time in adolescents.,"BACKGROUND This study aimed to evaluate the effectiveness of obesity prevention educational activities, isolated or combined with the modification of the school environment on total physical activity time. METHODS This is a school-based randomized controlled trial, conducted with 2511 students from fifth and sixth-grade in Brazil, that employed a parallel, three-group experimental arms: control group (CG), PAAPPAS group (PG) and PAAPPAS-environment group (PEG). During the 2016 school year, the PG received educational activities in the classroom, providing a general basis for a healthy lifestyle. The PEG received the same educational activities and also modifications in the school environment to stimulate physical activity practice during one month. Physical activity was evaluated through a validated physical activity questionnaire. Intention-to-treat analysis was performed to evaluate the rate of change of physical activity time between groups using PROC GENMOD procedure. All analyses were performed using SAS. RESULTS Total physical activity time increased by 22% in PEG compared with CG (P = 0.003). No difference was observed between PEG and PG (Δ = 60.20 vs. 36.37, respectively; P = 0.27) and between PG and CG (Δ = 36.37 vs. 9.70, respectively; P = 0.23). The proportion of individuals who attended at least 150 min week-1 of physical activity increased in PEG compared with PG (P = 0.04); however, no difference was observed between PEG and CG (P = 0.19) and between PG and CG (P = 0.26). For 300 min week-1, no difference was observed between groups. CONCLUSION A school-based multi-component intervention including modification of the school environment was effective for increasing physical activity time among adolescents.",2021,A school-based multi-component intervention including modification of the school environment was effective for increasing physical activity time among adolescents.,"['2511 students from fifth and sixth-grade in Brazil', 'adolescents']","['control group (CG), PAAPPAS group (PG) and PAAPPAS-environment group (PEG']","['rate of change of physical activity time', 'Physical activity', 'PEG and PG', 'total physical activity time', 'physical activity', 'physical activity time', 'Total physical activity time']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0205440', 'cui_str': 'Sixth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",2511.0,0.0321168,A school-based multi-component intervention including modification of the school environment was effective for increasing physical activity time among adolescents.,"[{'ForeName': 'Lidiane da C', 'Initials': 'LDC', 'LastName': 'Morais', 'Affiliation': 'Department of Epidemiology, Institute of Social Medicine, State University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Vitor Barreto', 'Initials': 'VB', 'LastName': 'Paravidino', 'Affiliation': 'Department of Epidemiology, Institute of Social Medicine, State University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Mauro F F', 'Initials': 'MFF', 'LastName': 'Mediano', 'Affiliation': 'Evandro Chagas National Institute of Infectious Disease, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Raycauan', 'Initials': 'R', 'LastName': 'Benthroldo', 'Affiliation': 'Department of Epidemiology, Institute of Social Medicine, State University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Tatiana R', 'Initials': 'TR', 'LastName': 'Gonçalves', 'Affiliation': 'Department of Epidemiology, Institute of Social Medicine, State University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Michele R', 'Initials': 'MR', 'LastName': 'Sgambato', 'Affiliation': 'Department of Epidemiology, Institute of Social Medicine, State University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Bárbara da S N', 'Initials': 'BDSN', 'LastName': 'de Souza', 'Affiliation': 'Institute of Collective Health, Federal University of Mato Grosso, Cuiabá, Brazil.'}, {'ForeName': 'Eliseu V', 'Initials': 'EV', 'LastName': 'Junior', 'Affiliation': 'Department of Epidemiology, Institute of Social Medicine, State University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Emanuele S', 'Initials': 'ES', 'LastName': 'Marques', 'Affiliation': 'Department of Epidemiology, Institute of Social Medicine, State University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Rosângela A', 'Initials': 'RA', 'LastName': 'Pereira', 'Affiliation': 'Department of Social and Applied Nutrition, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Rosely', 'Initials': 'R', 'LastName': 'Sichieri', 'Affiliation': 'Department of Epidemiology, Institute of Social Medicine, State University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Diana B', 'Initials': 'DB', 'LastName': 'Cunha', 'Affiliation': 'Department of Epidemiology, Institute of Social Medicine, State University of Rio de Janeiro, Rio de Janeiro, Brazil.'}]",European journal of public health,['10.1093/eurpub/ckab025'] 4067,33846728,MANual vs. automatIC local activation time annotation for guiding Premature Ventricular Complex ablation procedures (MANIaC-PVC study).,"AIMS To assess potential benefits of a local activation time (LAT) automatic acquisition protocol using wavefront annotation plus an ECG pattern matching algorithm [automatic (AUT)-arm] during premature ventricular complex (PVC) ablation procedures. METHODS AND RESULTS Prospective, randomized, controlled, and international multicentre study (NCT03340922). One hundred consecutive patients with indication for PVC ablation were enrolled and randomized to AUT (n = 50) or manual (MAN, n = 50) annotation protocols using the CARTO3 navigation system. The primary endpoint was mapping success. Clinical success was defined as a PVC-burden reduction of ≥80% in the 24-h Holter within 6 months after the procedure. Mean age was 56 ± 14 years, 54% men. The mean baseline PVC burden was 25 ± 13%, and mean left ventricular ejection fraction (LVEF) 55 ± 11%. Baseline characteristics were similar between the groups. The most frequent PVC-site of origin were right ventricular outflow tract (41%), LV (25%), and left ventricular outflow tract (17%), without differences between groups. Radiofrequency (RF) time and number of RF applications were similar for both groups. Mapping and procedure times were significantly shorter in the AUT-arm (25.5 ± 14.3 vs. 32.8 ± 12.6 min, P = 0.009; and 54.8 ± 24.8 vs. 67.4 ± 25.2, P = 0.014, respectively), while more mapping points were acquired [136 (94-222) AUT vs. 79 (52-111) MAN; P < 0.001]. Mapping and clinical success were similar in both groups. There were no procedure-related complications. CONCLUSION The use of a complete automatic protocol for LAT annotation during PVC ablation procedures allows to achieve similar clinical endpoints with higher procedural efficiency when compared with conventional, manual annotation carried out by expert operators.",2021,"There were no procedure-related complications. ","['Mean age was 56\u2009±\u200914\u2009years, 54% men', 'One hundred consecutive patients with indication for PVC ablation']","['manual (MAN, n\u2009=\u200950) annotation protocols using the CARTO3 navigation system', 'local activation time (LAT) automatic acquisition protocol using wavefront annotation plus an ECG pattern matching algorithm [automatic (AUT)-arm', 'AUT', 'MANual vs. automatIC local activation time annotation']","['left ventricular outflow tract', 'mean baseline PVC burden', 'Mapping and clinical success', 'Clinical success', 'Radiofrequency (RF) time and number of RF applications']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0151636', 'cui_str': 'Ventricular premature beats'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3539095', 'cui_str': 'Annotation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C4075648', 'cui_str': 'Navigation system'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0225912', 'cui_str': 'Structure of outflow tract of left ventricle'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0151636', 'cui_str': 'Ventricular premature beats'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0185125', 'cui_str': 'Application'}]",100.0,0.046671,"There were no procedure-related complications. ","[{'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Jáuregui', 'Affiliation': 'Heart Institute, Teknon Medical Center, C/Vilana, 12, 08022 Barcelona, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Fernández-Armenta', 'Affiliation': 'Puerta del Mar University Hospital, Cádiz, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Acosta', 'Affiliation': 'Virgen del Rocío University Hospital, Sevilla, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Penela', 'Affiliation': 'Heart Institute, Teknon Medical Center, C/Vilana, 12, 08022 Barcelona, Spain.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Terés', 'Affiliation': 'Heart Institute, Teknon Medical Center, C/Vilana, 12, 08022 Barcelona, Spain.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Ordóñez', 'Affiliation': 'Heart Institute, Teknon Medical Center, C/Vilana, 12, 08022 Barcelona, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Soto-Iglesias', 'Affiliation': 'Heart Institute, Teknon Medical Center, C/Vilana, 12, 08022 Barcelona, Spain.'}, {'ForeName': 'Etelvino', 'Initials': 'E', 'LastName': 'Silva', 'Affiliation': 'Puerta del Mar University Hospital, Cádiz, Spain.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Chauca', 'Affiliation': 'Heart Institute, Teknon Medical Center, C/Vilana, 12, 08022 Barcelona, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Carreño', 'Affiliation': 'Heart Institute, Teknon Medical Center, C/Vilana, 12, 08022 Barcelona, Spain.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Scherer', 'Affiliation': 'Heart Institute, Teknon Medical Center, C/Vilana, 12, 08022 Barcelona, Spain.'}, {'ForeName': 'Alonso', 'Initials': 'A', 'LastName': 'Pedrote', 'Affiliation': 'Virgen del Rocío University Hospital, Sevilla, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Berruezo', 'Affiliation': 'Heart Institute, Teknon Medical Center, C/Vilana, 12, 08022 Barcelona, Spain.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euab080'] 4068,33846088,"Short term heat acclimation reduces heat strain during a first, but not second, consecutive exercise-heat exposure.","OBJECTIVES Determine whether five days of heat acclimation reduces cardiovascular and thermoregulatory strain during consecutive exercise-heat exposures on the sixth day in the heat. DESIGN Pair-matched randomized control trial. METHODS Twenty-four males completed two, 120min exercise sessions (Session 1, Session 2) in a single day before (Day 1) and after (Day 6) four additional days of exercise in either hot (HOT: 40°C, 40% relative humidity, n=16) or temperate (CON: 23°C, 25% relative humidity, n=8) environments. A mixed-methods heat acclimation approach was implemented. Day 2 consisted of 120min of moderate-high intensity treadmill exercise. Days 3-5 consisted of 90min of moderate-high intensity exercise, with HOT completing this in a hyperthermia clamped manner at rectal temperature ≥38.5°C, and CON<38.5°C. RESULTS Session 1 end of exercise rectal temperature and heart rate were lower on Day 6 compared to Day 1 for HOT (p=0.012, p=0.003) but not CON (p=0.152, p=0.437). Session 2 end of exercise rectal temperature was not different between days for HOT (p=0.104) or CON (p=0.275). Session 2 end of exercise heart rate was lower on Day 6 compared to Day 1 for HOT (p=0.004) and CON (p=0.039). Session 1 sweat sensitivity was greater on Day 6 compared to Day 1 for HOT (p=0.039) but not CON (p=0.257). Sweat rate was unchanged for HOT and CON between days during Session 1 (p=0.184, p=0.962) and Session 2 (p=0.051, p=0.793), respectively. CONCLUSIONS Five days of heat acclimation reduced cardiovascular strain but not thermoregulatory strain during the second, consecutive exercise-heat exposure. CLINICALTRIALS. GOV IDENTIFIER NCT04053465.",2021,Session 1 sweat sensitivity was greater on Day 6 compared to Day 1 for HOT (p=0.039) but not CON (p=0.257).,['Twenty-four males completed two'],"['moderate-high intensity treadmill exercise', '120min exercise sessions', 'CON<38.5', 'heat acclimation']","['exercise rectal temperature and heart rate', 'cardiovascular and thermoregulatory strain', 'sweat sensitivity', 'exercise heart rate', 'exercise rectal temperature', 'reduced cardiovascular strain', 'Sweat rate']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0489749', 'cui_str': 'Rectal temperature'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0038984', 'cui_str': 'Sweat'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",24.0,0.0963824,Session 1 sweat sensitivity was greater on Day 6 compared to Day 1 for HOT (p=0.039) but not CON (p=0.257).,"[{'ForeName': 'Riana R', 'Initials': 'RR', 'LastName': 'Pryor', 'Affiliation': 'Center for Research and Education in Special Environments, Department of Exercise and Nutrition Sciences, University at Buffalo, SUNY, USA; Korey Stringer Institute, Department of Kinesiology, University of Connecticut, USA. Electronic address: rpryor@buffalo.edu.'}, {'ForeName': 'J Luke', 'Initials': 'JL', 'LastName': 'Pryor', 'Affiliation': 'Center for Research and Education in Special Environments, Department of Exercise and Nutrition Sciences, University at Buffalo, SUNY, USA.'}, {'ForeName': 'Lesley W', 'Initials': 'LW', 'LastName': 'Vandermark', 'Affiliation': 'Center for Research and Education in Special Environments, Department of Exercise and Nutrition Sciences, University at Buffalo, SUNY, USA.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Adams', 'Affiliation': 'Korey Stringer Institute, Department of Kinesiology, University of Connecticut, USA.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Brodeur', 'Affiliation': 'Korey Stringer Institute, Department of Kinesiology, University of Connecticut, USA.'}, {'ForeName': 'Lawrence E', 'Initials': 'LE', 'LastName': 'Armstrong', 'Affiliation': 'Korey Stringer Institute, Department of Kinesiology, University of Connecticut, USA.'}, {'ForeName': 'Elaine C', 'Initials': 'EC', 'LastName': 'Lee', 'Affiliation': 'Korey Stringer Institute, Department of Kinesiology, University of Connecticut, USA.'}, {'ForeName': 'Carl M', 'Initials': 'CM', 'LastName': 'Maresh', 'Affiliation': 'Department of Human Sciences, The Ohio State University, USA.'}, {'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Casa', 'Affiliation': 'Korey Stringer Institute, Department of Kinesiology, University of Connecticut, USA.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2021.03.020'] 4069,33846086,Objective evaluation of static and dynamic behavior of different toric silicone-hydrogel contact lenses.,"PURPOSE The present study aimed to estimate how orientation position, recovery time, and contact lens decentration, associated with visual performance, may vary on several designs of the most recent toric silicone-hydrogel toric contact lenses in two-time different moments. METHODS To evaluate the toric silicone-hydrogel toric contact lens position and stability, it was conducted with a prospective, observational, randomized, and single-center case series including 95 astigmatic eyes wearing four toric silicone-hydrogel toric contact lenses for two weeks. Orientation and decentration were analyzed with ImageJ software from video-frames extracted with a Python application. Recovery time was evaluated after 45 degrees of inferior-temporal misorientation. RESULTS Evaluation of misorientation after 20 min of wear revealed the highest amount for Saphir RX, -20.41 ± 10.84 deg, and lowest for Air Optix Aqua for Astigmatism, -1.43 ± 7.48 deg. The highest horizontal misalignment was found for Air Optix Aqua for Astigmatism, -0.627 ± 0.330 mm, and lowest for Biofinity Toric, 0.004 ± 0.270 mm. Vertical misalignment presented the highest value for Acuvue Vita for Astigmatism, -0.652 ± 0.369 mm, and lowest for Air Optix Aqua for Astigmatism, -0.126 ± 0.231 mm. Recovery time showed the highest amount for Saphir RX, 80.70 ± 33.26 s, and lowest for Biofinity Toric 43.67 ± 23.70 s. Only Air Optix Aqua for Astigmatism presented significant differences after two-week of wear for misorientation (P = 0.02) and horizontal misalignment (P < 0.001). When pairwise comparisons are made between toric silicone-hydrogel toric contact lenses, significant differences (P < 0.001) are found. CONCLUSIONS Although there was acceptable fitting, based upon decentration, orientation, and recovery with the study contact lenses, the stabilization and profile design used in the Air Optix Aqua for Astigmatism helped to minimize rotation and vertical misalignment. In addition, the peri-ballast and thickness profile of the Biofinity Toric improved rotational recovery and horizontal misalignment compared to the other contact lenses. Finally, lenses with a better fitting profile showed better visual performance.",2021,"Vertical misalignment presented the highest value for Acuvue Vita for Astigmatism, -0.652 ± 0.369 mm, and lowest for Air Optix Aqua for Astigmatism, -0.126 ± 0.231 mm.",['95 astigmatic eyes wearing four toric silicone-hydrogel toric contact lenses for two weeks'],"['toric silicone-hydrogel toric contact lens position', 'toric silicone-hydrogel contact lenses']","['rotational recovery and horizontal misalignment', 'visual performance', 'Recovery time', 'horizontal misalignment', 'highest horizontal misalignment']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel'}, {'cui': 'C0009836', 'cui_str': 'Contact lenses'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}]","[{'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel'}, {'cui': 'C0009836', 'cui_str': 'Contact lenses'}, {'cui': 'C0733755', 'cui_str': 'Position'}]","[{'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C1275957', 'cui_str': 'Misalignment'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205250', 'cui_str': 'High'}]",4.0,0.0667397,"Vertical misalignment presented the highest value for Acuvue Vita for Astigmatism, -0.652 ± 0.369 mm, and lowest for Air Optix Aqua for Astigmatism, -0.126 ± 0.231 mm.","[{'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Sánchez-García', 'Affiliation': 'Ocular Surface and Contact Lens Research Laboratory, Faculty of Optics and Optometry, University of Santiago de Compostela, Spain. Electronic address: anxo.sanchez@usc.es.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'González-Pérez', 'Affiliation': 'Ocular Surface and Contact Lens Research Laboratory, Faculty of Optics and Optometry, University of Santiago de Compostela, Spain.'}]",Contact lens & anterior eye : the journal of the British Contact Lens Association,['10.1016/j.clae.2021.03.004'] 4070,33846083,Effects of anxiety-related psychological states on music-induced analgesia in cold pressor pain responses.,"CONTEXT The analgesic effect of music has long been reported. OBJECTIVE To assess how anxiety-related psychological states affect the analgesic effect of music using the cold pressor task (CPT). DESIGN A 3-period × 3-sequence crossover design was adopted; three conditions were used: ""no sound,"" ""music-listening,"" and ""news-listening."" SETTING PARTICIPANTS: Forty-nine participants were included. INTERVENTIONS After completing five anxiety-related psychological instruments (Anxiety Sensitivity Index [ASI]-16, ASI-Revised, State-Trait Anxiety Inventory [STAI]-S, STAI-T, and Pain Anxiety Symptoms Scale-20), the participants were allocated to the low- or high-anxiety group. The high- and low-anxiety groups were defined based on cutoff points according to the distributions and characteristics of the five instruments. MAIN OUTCOME MEASURES Pain responses, such as pain tolerance time, pain intensity, and pain unpleasantness, were measured on the CPT. Pain responses in the music-listening condition were also compared to those in the other two conditions via pairwise comparisons within each anxiety group. RESULTS The Cronbach alpha of the five instruments ranged from 0.866 to 0.95, indicating that they were reliable. Pain responses in the music-listening condition in the low-anxiety groups based on any of the five scales were significantly different from those in the other conditions, but this effect was not found in the high-anxiety groups. This study demonstrates that anxiety-related psychological states can predict the analgesic effect of music on pain responses measured by the CPT and suggests that music may be beneficial as a pain management tool in low-anxiety groups.",2021,"Pain responses in the music-listening condition in the low-anxiety groups based on any of the five scales were significantly different from those in the other conditions, but this effect was not found in the high-anxiety groups.",[' Forty-nine participants were included'],"['cold pressor task (CPT', 'music-induced analgesia', 'no sound,"" ""music-listening,"" and ""news-listening']","['psychological instruments (Anxiety Sensitivity Index [ASI]-16, ASI-Revised, State-Trait Anxiety Inventory [STAI]-S, STAI-T, and Pain Anxiety Symptoms Scale-20', 'cold pressor pain responses', 'Pain responses, such as pain tolerance time, pain intensity, and pain unpleasantness', 'Pain responses', 'pain responses']","[{'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0282425', 'cui_str': 'News'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0450981', 'cui_str': 'Addiction severity index'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",49.0,0.0191159,"Pain responses in the music-listening condition in the low-anxiety groups based on any of the five scales were significantly different from those in the other conditions, but this effect was not found in the high-anxiety groups.","[{'ForeName': 'Suvin', 'Initials': 'S', 'LastName': 'Choi', 'Affiliation': 'Da Vinci College of General Education, Chung-Ang University, Seoul, Korea.'}, {'ForeName': 'Sang-Gue', 'Initials': 'SG', 'LastName': 'Park', 'Affiliation': 'Department of Applied Statistics, Chung-Ang University, Seoul, Korea. Electronic address: spark@cau.ac.kr.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2021.03.003'] 4071,33846054,Centralized Reminder/Recall for Human Papillomavirus Vaccination: Findings From Two States-A Randomized Clinical Trial.,"PURPOSE Centralized reminder/recall (C-R/R) using Immunization Information Systems has been effective in increasing childhood immunization rates. Previously, C-R/R using autodialer for human papillomavirus (HPV) vaccine did not raise rates. We assessed C-R/R for HPV vaccine using other modalities and focused on younger adolescents. METHODS We conducted a three-arm pragmatic RCT in randomly sampled primary care practices in Colorado (n = 88) and New York (n = 136), proportionate to where adolescents received care. We randomized, within practices, adolescents aged 11-14 years who had not completed the HPV vaccination series to receive C-R/R using different modalities (Colorado: autodialer, mail, or control; New York: autodialer, text, or control). Up to two reminders were sent in intervention arms for each dose needed between 2/2017 and 12/2018. RESULTS In Colorado, no significant differences were found for series initiation (31.3% control, 31.1% autodial, 31.8% mail), with slight improvement for series completion in the autodialer arm (29.7% control, 31.1% autodialer, p = .04) but not the mail arm (30.9%, p = .06). No significant differences were found in New York for series initiation (24.1% for all arms) or completion (17.1% control, 16.9% autodial, 17.9% text). Adjusted analyses showed higher completion rates for the autodialer arm in Colorado but not for other arms. In Colorado, C-R/R reduced time to series completion by around 2 months. Cost per adolescent was $1.81 for mail; under $.40 for all other modalities. CONCLUSIONS C-R/R has less benefit for raising HPV vaccination rates than other studies have noted for childhood immunizations, although it may quicken series completion at little cost.",2021,"CONCLUSIONS C-R/R has less benefit for raising HPV vaccination rates than other studies have noted for childhood immunizations, although it may quicken series completion at little cost.","['adolescents aged 11-14 years who had not completed the HPV vaccination series to receive', 'Human Papillomavirus', 'randomly sampled primary care practices in Colorado (n\xa0= 88) and New York']","['Vaccination', 'C-R/R using different modalities (Colorado: autodialer, mail, or control; New York: autodialer, text, or control']","['series initiation', 'New York for series initiation', 'Cost per adolescent', 'completion rates']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1444661', 'cui_str': 'Stopped before completion'}, {'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0027976', 'cui_str': 'New York'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",2.0,0.0999933,"CONCLUSIONS C-R/R has less benefit for raising HPV vaccination rates than other studies have noted for childhood immunizations, although it may quicken series completion at little cost.","[{'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Gurfinkel', 'Affiliation': ""Adult and Child Consortium For Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, Colorado. Electronic address: dennis.gurfinkel@cuanschutz.edu.""}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Kempe', 'Affiliation': ""Adult and Child Consortium For Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, Colorado; Department of Pediatrics, University of Colorado School of Medicine, Aurora, Colorado.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Albertin', 'Affiliation': ""Department of Pediatrics, UCLA Mattel Children's Hospital, University of California at Los Angeles, Los Angeles, California.""}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Breck', 'Affiliation': ""Department of Pediatrics, UCLA Mattel Children's Hospital, University of California at Los Angeles, Los Angeles, California.""}, {'ForeName': 'Xinkai', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Medicine, Statistics Core, David Geffen School of Medicine, University of California, Los Angeles, California.'}, {'ForeName': 'Sitaram', 'Initials': 'S', 'LastName': 'Vangala', 'Affiliation': 'Department of Medicine, Statistics Core, David Geffen School of Medicine, University of California, Los Angeles, California.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Beaty', 'Affiliation': ""Adult and Child Consortium For Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, Colorado.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rice', 'Affiliation': ""Adult and Child Consortium For Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, Colorado; Department of Biostatistics and Informatics, Colorado School of Public Health, Aurora, Colorado.""}, {'ForeName': 'Chi-Hong', 'Initials': 'CH', 'LastName': 'Tseng', 'Affiliation': 'Department of Medicine, Statistics Core, David Geffen School of Medicine, University of California, Los Angeles, California.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Campbell', 'Affiliation': 'Department of Clinical Pharmacy, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Valderrama', 'Affiliation': ""Department of Pediatrics, UCLA Mattel Children's Hospital, University of California at Los Angeles, Los Angeles, California.""}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Rand', 'Affiliation': 'Department of Pediatrics, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Sharon G', 'Initials': 'SG', 'LastName': 'Humiston', 'Affiliation': ""Department of Pediatrics, Children's Mercy, Kansas City, Missouri.""}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Roth', 'Affiliation': 'Colorado Immunization Information System, Colorado Department of Public Health and Environment, Denver, Colorado.'}, {'ForeName': 'Shivani', 'Initials': 'S', 'LastName': 'Arora', 'Affiliation': 'New York State Immunization Information System, New York State Department of Health, Albany, New York.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Szilagyi', 'Affiliation': ""Department of Pediatrics, UCLA Mattel Children's Hospital, University of California at Los Angeles, Los Angeles, California.""}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2021.02.023'] 4072,33846037,No benefit of more intense follow-up after surgery for colorectal cancer in the risk group with elevated CEA levels - An analysis within the COLOFOL randomized clinical trial.,"BACKGROUND Patients with colorectal cancer were examined to determine (1) whether elevated carcinoembryonic antigen (CEA) levels, either before treatment or after surgery, was associated with an increased risk of overall or colorectal cancer-specific mortality or recurrence, and (2) whether high intensity follow-up would benefit those patients. MATERIALS AND METHODS Post-hoc analysis based on 2509 patients that underwent surgery for colorectal cancer, stage II or III, in the COLOFOL randomized trial with 5-year follow-up. Serum CEA levels were ascertained before treatment and one month after surgery. Follow-up examinations included computed tomography of the thorax and abdomen and serum CEA sampling. Patients were randomized to examinations at either 6, 12, 18, 24, and 36 months (high-intensity group) or at 12 and 36 months after surgery (low-intensity group). Levels of CEA >5 μg/l were defined as elevated. RESULTS Elevated CEA levels before treatment were associated with increased risk of recurrence (hazard ratio [HR], 1.49; 95% confidence interval [CI]: 1.22-1.83), colorectal cancer-specific mortality (HR, 1.44; 95% CI: 1.08-1.91), and overall mortality (HR, 1.38; 95% CI: 1.07-1.78). Elevated CEA levels after surgery were associated with increased colorectal cancer-specific mortality (HR, 1.68; 95% CI: 1.08-2.61) and overall mortality (HR, 1.79; 95% CI: 1.22-2.63). The intensity of the follow-up regimen had no effect on 5-year outcomes in patients with elevated CEA levels. CONCLUSION Both pre-treatment and post-surgery elevated serum CEA levels were associated with increased overall and cancer-specific mortality. Intensified follow-up showed no benefit over low-intensity follow-up in this high-risk group of patients with elevated CEA levels.",2021,Intensified follow-up showed no benefit over low-intensity follow-up in this high-risk group of patients with elevated CEA levels.,"['patients with elevated CEA levels', '2509 patients that underwent surgery for colorectal cancer, stage II or III, in the COLOFOL randomized trial with 5-year follow-up', 'Patients with colorectal cancer']",[],"['risk of recurrence', 'overall mortality', 'colorectal cancer-specific mortality', 'risk of overall or colorectal cancer-specific mortality or recurrence', 'elevated carcinoembryonic antigen (CEA) levels', 'serum CEA levels', 'Serum CEA levels', 'Elevated CEA levels', 'overall and cancer-specific mortality', '5-year outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0007082', 'cui_str': 'Carcinoembryonic antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0007082', 'cui_str': 'Carcinoembryonic antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",2509.0,0.235801,Intensified follow-up showed no benefit over low-intensity follow-up in this high-risk group of patients with elevated CEA levels.,"[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Egenvall', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Department of Pelvic Cancer, Colorectal Surgery Unit, Karolinska University Hospital, D1:05, 171 76, Stockholm, Sweden. Electronic address: monika.egenvall@ki.se.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Martling', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Department of Pelvic Cancer, Colorectal Surgery Unit, Karolinska University Hospital, D1:05, 171 76, Stockholm, Sweden. Electronic address: anna.martling@ki.se.'}, {'ForeName': 'Katalin', 'Initials': 'K', 'LastName': 'Veres', 'Affiliation': 'Department of Clinical Epidemiology, Aarhus University Hospital, 8200, Aarhus, Denmark. Electronic address: katalin.veres@clin.au.dk.'}, {'ForeName': 'Erzsébet', 'Initials': 'E', 'LastName': 'Horváth-Puhó', 'Affiliation': 'Department of Clinical Epidemiology, Aarhus University Hospital, 8200, Aarhus, Denmark. Electronic address: ep@clin.au.dk.'}, {'ForeName': 'Peer', 'Initials': 'P', 'LastName': 'Wille-Jørgensen', 'Affiliation': 'Department of Gastroenterology K, Bispebjerg University Hospital, 2400, Copenhagen, Denmark. Electronic address: peerwille@vip.cybercity.dk.'}, {'ForeName': 'Sune', 'Initials': 'S', 'LastName': 'Høirup Petersen', 'Affiliation': 'Department of Gastroenterology K, Bispebjerg University Hospital, 2400, Copenhagen, Denmark. Electronic address: sune.hoeirup.petersen.01@regionh.dk.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Laurberg', 'Affiliation': 'Department of Surgery, Aarhus University Hospital, 8200, Aarhus, Denmark. Electronic address: slaurberg@yahoo.dk.'}, {'ForeName': 'Henrik Toft', 'Initials': 'HT', 'LastName': 'Sørensen', 'Affiliation': 'Department of Clinical Epidemiology, Aarhus University Hospital, 8200, Aarhus, Denmark. Electronic address: hts@clin.au.dk.'}, {'ForeName': 'Ingvar', 'Initials': 'I', 'LastName': 'Syk', 'Affiliation': 'Department of Surgery, Skåne University Hospital, 205 02, Malmö, Sweden. Electronic address: ingvar.syk@telia.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology,['10.1016/j.ejso.2021.03.235'] 4073,33846004,Simplified glycaemic management for patients with type 2 diabetes admitted for acute decompensated heart failure using linagliptin.,"INTRODUCTION AND OBJECTIVES Hyperglycaemia in hospitalized patients with type 2 diabetes is preferably managed with insulin. We aimed to analyse the glycaemic efficacy, treatment simplicity, and safety of our hospital's antihyperglycemic regimens (linagliptin-basal insulin versus basal-bolus insulin) in patients with type 2 diabetes admitted for heart failure decompensation. PATIENTS AND METHODS In this real-world study, we included patients with mild-to-moderate hyperglycaemia managed with our antihyperglycemic regimens between 2016 and 2018. To match patients who started one of the regimens, a propensity matching analysis was used. RESULTS After propensity matching, 146 patients were included in each group. There were no differences in mean blood glucose levels (163.6±21.2 vs 159.6±19.2mg/dl, p=.210). Patients on the linagliptin-basal insulin regimen had a lower total number of hypoglycaemic episodes (36 vs 64, p<.001), lower total insulin dose (24.1±5.3 vs 32.0±5.6 units, p<.001), and lower number of daily injections (2.4±.8 vs 4.0±.0, p<.001) than those on the basal-bolus regimen. CONCLUSIONS Linagliptin-basal insulin was a safe, simple, and efficacious regimen and could be considered standard of care for these vulnerable, high complex patients to simplify in-hospital management.",2021,"There were no differences in mean blood glucose levels (163.6±21.2 vs 159.6±19.2mg/dl, p=.210).","['patients with mild-to-moderate hyperglycaemia managed with our antihyperglycemic regimens between 2016 and 2018', '146 patients were included in each group', 'hospitalized patients with type 2 diabetes', 'patients with type 2 diabetes admitted for heart failure decompensation', 'patients with type 2 diabetes admitted for acute decompensated heart failure using']","[""hospital's antihyperglycemic regimens (linagliptin-basal insulin versus basal-bolus insulin"", 'linagliptin-basal insulin regimen', 'Linagliptin-basal insulin', 'Simplified glycaemic management', 'linagliptin']","['total number of hypoglycaemic episodes', 'mean blood glucose levels', 'glycaemic efficacy', 'lower total insulin dose', 'lower number of daily injections']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0231187', 'cui_str': 'Decompensation'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0745153', 'cui_str': 'Hypoglycaemic episode'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]",146.0,0.1023,"There were no differences in mean blood glucose levels (163.6±21.2 vs 159.6±19.2mg/dl, p=.210).","[{'ForeName': 'Luis M', 'Initials': 'LM', 'LastName': 'Pérez-Belmonte', 'Affiliation': 'Servicio de Medicina Interna, Hospital Regional Universitario de Málaga, Instituto de Investigación Biomédica de Málaga (IBIMA), Universidad de Málaga (UMA), Málaga, Spain; Servicio de Medicina Interna, Hospital Helicópteros Sanitarios, Marbella, Spain; Unidad de Neurofisiología Cognitiva, Centro de Investigaciones Médico Sanitarias (CIMES), Facultad de Medicina, Universidad de Málaga (UMA), Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain; Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV), Instituto de Salud Carlos III, Madrid, Spain. Electronic address: luismiguelpb1984@gmail.com.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Osuna-Sánchez', 'Affiliation': 'Unidad de Neurofisiología Cognitiva, Centro de Investigaciones Médico Sanitarias (CIMES), Facultad de Medicina, Universidad de Málaga (UMA), Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain; Servicio de Medicina Interna, Hospital Comarcal de La Axarquía, Vélez-Málaga, Málaga, Spain.'}, {'ForeName': 'Juan Ignacio', 'Initials': 'JI', 'LastName': 'Rico-Robles', 'Affiliation': 'Servicio de Medicina Interna, Hospital Regional Universitario de Málaga, Instituto de Investigación Biomédica de Málaga (IBIMA), Universidad de Málaga (UMA), Málaga, Spain; Servicio de Medicina Interna, Hospital Helicópteros Sanitarios, Marbella, Spain.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Ricci', 'Affiliation': 'Servicio de Medicina Interna, Hospital Regional Universitario de Málaga, Instituto de Investigación Biomédica de Málaga (IBIMA), Universidad de Málaga (UMA), Málaga, Spain.'}, {'ForeName': 'José P', 'Initials': 'JP', 'LastName': 'Lara', 'Affiliation': 'Unidad de Neurofisiología Cognitiva, Centro de Investigaciones Médico Sanitarias (CIMES), Facultad de Medicina, Universidad de Málaga (UMA), Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Gómez-Huelgas', 'Affiliation': 'Servicio de Medicina Interna, Hospital Regional Universitario de Málaga, Instituto de Investigación Biomédica de Málaga (IBIMA), Universidad de Málaga (UMA), Málaga, Spain; Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERobn), Instituto de Salud Carlos III, Madrid, Spain.'}]",Medicina clinica,['10.1016/j.medcli.2021.02.009'] 4074,33845988,"Hyaluronic acid-enriched transfer medium for frozen embryo transfer: a randomized, double-blind, controlled trial.","OBJECTIVE To compare the effects of hyaluronic acid (HA)-enriched transfer medium versus standard medium on live birth rate after frozen embryo transfer (FET). DESIGN Randomized, double-blind, controlled trial. SETTING Two tertiary fertility centers. PATIENT(S) Infertile women aged <43 years at the time of in vitro fertilization undergoing FET. INTERVENTION(S) The women were randomly assigned to 2 groups in a 1:1 ratio. The HA group used EmbryoGlue (Vitrolife, Gothenburg, Sweden) with an HA concentration of 0.5 mg/mL, while the control group used supplemented G-2 (Vitrolife) medium with an HA concentration of 0.125 mg/mL. MAIN OUTCOME MEASURE(S) Live birth rate. RESULT(S) Five hundred fifty women were recruited from April 2016 to April 2018 and included in the intention-to-treat analysis. Eight women in the HA group and 5 women in the control group did not undergo FET because the embryos did not survive on thawing. One woman in the HA group cancelled FET because of fever. One woman in the HA group withdrew and received conventional medium. The 2 groups were similar in demographic characteristics. The live birth rates in the HA group and the control group were comparable (25.5% vs. 25.8%; relative risk 0.99; 95% confidence interval 0.74-1.31). The other clinical outcomes were also similar between the 2 groups. Logistic regression showed that the type of transfer medium was not associated with live birth. CONCLUSION(S) The use of HA-enriched transfer medium does not improve the live birth rate of FET compared with standard medium. TRIAL REGISTRATION NUMBER NCT02725827 (ClinicalTrials.gov).",2021,Eight women in the HA group and 5 women in the control group did not undergo FET because the embryos did not survive on thawing.,"['Five hundred fifty women were recruited from April 2016 to April 2018 and included in the intention-to-treat analysis', 'Infertile women aged <43 years at the time of in\xa0vitro fertilization undergoing FET', 'frozen embryo transfer', 'Two tertiary fertility centers']","['Hyaluronic acid-enriched transfer medium', 'conventional medium', 'hyaluronic acid (HA)-enriched transfer medium versus standard medium']","['live birth rate', 'live birth rates', 'live birth rate of FET', 'FET because of fever']","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer'}, {'cui': 'C0015967', 'cui_str': 'Fever'}]",550.0,0.472701,Eight women in the HA group and 5 women in the control group did not undergo FET because the embryos did not survive on thawing.,"[{'ForeName': 'Sofie Shuk Fei', 'Initials': 'SSF', 'LastName': 'Yung', 'Affiliation': ""Department of Obstetrics and Gynaecology, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, People's Republic of China. Electronic address: ssfyung@hku.hk.""}, {'ForeName': 'Shui Fan', 'Initials': 'SF', 'LastName': 'Lai', 'Affiliation': ""Department of Obstetrics and Gynaecology, Kwong Wah Hospital, Yaumatei, Kowloon, Hong Kong Special Administrative Region, People's Republic of China.""}, {'ForeName': 'Mei Ting', 'Initials': 'MT', 'LastName': 'Lam', 'Affiliation': ""Department of Obstetrics and Gynaecology, Kwong Wah Hospital, Yaumatei, Kowloon, Hong Kong Special Administrative Region, People's Republic of China.""}, {'ForeName': 'Ellen Man Wa', 'Initials': 'EMW', 'LastName': 'Lui', 'Affiliation': ""Department of Obstetrics and Gynaecology, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, People's Republic of China.""}, {'ForeName': 'Jennifer Ka Yee', 'Initials': 'JKY', 'LastName': 'Ko', 'Affiliation': ""Department of Obstetrics and Gynaecology, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, People's Republic of China.""}, {'ForeName': 'Hang Wun Raymond', 'Initials': 'HWR', 'LastName': 'Li', 'Affiliation': ""Department of Obstetrics and Gynaecology, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, People's Republic of China.""}, {'ForeName': 'Jacki Yuk Ying', 'Initials': 'JYY', 'LastName': 'Wong', 'Affiliation': ""Department of Obstetrics and Gynaecology, Kwong Wah Hospital, Yaumatei, Kowloon, Hong Kong Special Administrative Region, People's Republic of China.""}, {'ForeName': 'Estella Yee Lan', 'Initials': 'EYL', 'LastName': 'Lau', 'Affiliation': ""Department of Obstetrics and Gynaecology, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, People's Republic of China.""}, {'ForeName': 'William Shu Biu', 'Initials': 'WSB', 'LastName': 'Yeung', 'Affiliation': ""Department of Obstetrics and Gynaecology, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, People's Republic of China.""}, {'ForeName': 'Ernest Hung Yu', 'Initials': 'EHY', 'LastName': 'Ng', 'Affiliation': ""Department of Obstetrics and Gynaecology, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, People's Republic of China.""}]",Fertility and sterility,['10.1016/j.fertnstert.2021.02.015'] 4075,33845880,"Adding a smartphone app to global postural re-education to improve neck pain, posture, quality of life, and endurance in people with nonspecific neck pain: a randomized controlled trial.","BACKGROUND In this study, the effect of adding a smartphone app to an 8-week global postural reeducation (GPR) on neck pain, endurance, quality of life, and forward head posture (FHP) in patients with chronic neck pain and FHP was evaluated. METHODS Sixty male and female office workers (38.5 ± 9.1 years) with chronic neck pain were randomly assigned into three groups: group 1 (GPR+ a smartphone app, n = 20), group 2 (GPR alone, n = 20), and group 3 (the control group, n = 20). The primary outcome was pain and the secondary outcomes were disability, quality of life, endurance, and posture. Pain, disability, endurance, quality of life, and posture were evaluated using the visual analog scale (VAS), neck disability index (NDI), progressive iso-inertial lifting evaluation (PILE) test, quality of life questionnaire (SF-36), and photogrammetry, respectively, at pre-and post-8-week interventions. A one-way analysis of covariance (ANCOVA) has been conducted to statistically analyze the data. RESULTS The GPR+ a smartphone app had statistically significant improvements versus GPR alone in pain (mean difference, - 2.05 ± 0.65, ES (95% CI) - 0.50 (- 1.04 to - 0.01), P = 0.04), disability (difference = 11.5 ± 1.2, ES (95% CI) = 0.31 (0.22 to 0.97), p = 0.033), FHP (difference = 1.6 ± 0.2, ES (95% CI) = 0.31 (0.09 to 0.92), p = 0.047), and endurance (difference = 2 ± 3.3, ES (95% CI) = 0.51 (0.02 to 1.03), p = 0.039). Both of the GPR+ a smartphone app and GPR alone groups had statistically significant differences versus the control group in all outcomes. CONCLUSION When a workplace assessment and management could not be as part of any intervention, adding a smartphone app to GPR for NP may be an appropriate tool to administer a home and work exercise program resulting in elevating pain and disability, as well as improving FHP and endurance. TRIAL REGISTRATION Current Controlled Trials using the UMIN-RCT website UMIN000039720 . Retrospectively registered on January 9, 2020.",2021,"Both of the GPR+ a smartphone app and GPR alone groups had statistically significant differences versus the control group in all outcomes. ","['patients with chronic neck pain and FHP was evaluated', 'Sixty male and female office workers (38.5\u2009±\u20099.1\u2009years) with chronic neck pain', 'people with nonspecific neck pain']","['group 1 (GPR+ a smartphone app, n\u2009=\u200920), group 2 (GPR alone', 'smartphone app to an 8-week global postural reeducation (GPR', 'smartphone app to global postural re-education']","['disability', 'pain', 'neck pain, endurance, quality of life, and forward head posture (FHP', 'FHP', 'Pain, disability, endurance, quality of life, and posture were evaluated using the visual analog scale (VAS), neck disability index (NDI), progressive iso-inertial lifting evaluation (PILE) test, quality of life questionnaire (SF-36), and photogrammetry, respectively, at pre-and post-8-week interventions', 'disability, quality of life, endurance, and posture', 'neck pain, posture, quality of life, and endurance', 'GPR alone in pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C1536116', 'cui_str': 'Head posture abnormal'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}]","[{'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0454282', 'cui_str': 'Posture training'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C1536116', 'cui_str': 'Head posture abnormal'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031747', 'cui_str': 'Photogrammetry'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205278', 'cui_str': 'Postural'}]",60.0,0.113221,"Both of the GPR+ a smartphone app and GPR alone groups had statistically significant differences versus the control group in all outcomes. ","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Abadiyan', 'Affiliation': 'Faculty of Physical Education and Sport Sciences, Department of Biomechanics and Sport injuries, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Hadadnezhad', 'Affiliation': 'Faculty of Physical Education and Sport Sciences, Department of Biomechanics and Sport injuries, Kharazmi University, Tehran, Iran. m.hadadnezhad@yahoo.com.'}, {'ForeName': 'Zohre', 'Initials': 'Z', 'LastName': 'Khosrokiani', 'Affiliation': 'Faculty of Physical Education and Sport Sciences, Department of Biomechanics and Sport injuries, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Letafatkar', 'Affiliation': 'Faculty of Physical Education and Sport Sciences, Department of Biomechanics and Sport injuries, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Haniyeh', 'Initials': 'H', 'LastName': 'Akhshik', 'Affiliation': 'Faculty of Physical Education and Sport Sciences, Department of Biomechanics and Sport injuries, Kharazmi University, Tehran, Iran.'}]",Trials,['10.1186/s13063-021-05214-8'] 4076,33845878,Therapeutic respiratory and functional rehabilitation protocol for intensive care unit patients affected by COVID-19: a structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES The primary objective of the presented study is to analyze the respiratory and functional effects of a rehabilitation program in patients affected by hospitalization in Intensive Care Unit (ICU) due to COVID-19, in comparison with the group treated with standard of care, at discharge endpoint. The secondary objectives of the presented study are to evaluate different outcomes of the rehabilitation program in comparison to standard of care regarding: functional performance at 4-week and 12-week post- discharge mark; health-related quality of life, the impact on the health services (namely days of hospitalization), the cost-effectiveness of the intervention proposed. TRIAL DESIGN This is a randomized, controlled, double-blind, double-arm clinical trial of treatment, with an allocation ratio 1:1 and framework of superiority. PARTICIPANTS The study will be conducted at Centro Hospitalar Entre Douro e Vouga, Santa Maria da Feira, Portugal. Potential participants will be adult patients (≥18 years old) hospitalized in ICU with respiratory insufficiency due to COVID-19, who are referred to respiratory and functional rehabilitation. Only patients approved by physical rehabilitation doctors to perform respiratory and functional rehabilitation will be considered potential participants. To be eligible for inclusion participants must have been independent in their activities of daily living before the onset of critical illness (verbal statement by their proxy) and have to meet the safety criteria defined by the Portuguese Society of Physical Rehabilitation Medicine. INTERVENTION AND COMPARATOR Both groups will receive usual medical and nursing care in the ICU, which involves assessment and treatment of the respiratory system and may include positioning, hyperinflation techniques and suctioning. The physical function of the patient is assessed, and active bed exercises and mobility are encouraged as soon as possible and may include sitting out of bed. The intervention group will receive a functional and respiratory multidisciplinary rehabilitation protocol (that includes medical, nursing, physiotherapy and occupational therapy interventions) during their entire hospital stay. After reassurance that the patients fulfil the safety criteria, they will initiate the rehabilitation protocol, individualized to each patient based on the clinical status. The rehabilitation interventions and exercises implemented will be consistent with recommendations from the Portuguese Society of Physical Rehabilitation Medicine. The intervention will occur 6 days per week (Monday to Saturday), fifteen minutes, twice per day for each participant. Throughout all activities, progression will be increased successively, depending on the individual's tolerance and stability. After discharge, the intervention group will continue with rehabilitation exercises, prescribed by physical rehabilitation doctors. These exercises are designed for the patient to do at home, and then report their execution to rehabilitation nurses through teleconsultation, until 12 weeks after ICU discharge. MAIN OUTCOMES Baseline descriptive data collection will include age, sex, comorbidities and date of admission to ICU. The need of mechanical ventilation and length of use, as well as the need for oxygen therapy, length of ICU stay (days/hours), incidence of ICU readmission, discharge destination and survival will also be recorded. Prior to intervention, every two days and at discharge, participants will be evaluated using the following scales: Glasgow Coma Scale, Richmond Agitation Sedation Scale, Chelsea Critical Care Physical Assessment, 5 standardized questions for cooperation, Medical Research Council Sum-Score, Handgrip strength test and Medical Research Council dyspnea scale. At discharge, Borg Rating of Perceived Exertion will be evaluated. The primary outcome measure will be functional capacity using the 6-Minute Walk Test, and it will be measured at discharge and at the 4-week and 12-week mark. Medical Research Council Sum-Score, Handgrip strength test, Medical Research Council dyspnea scale and Borg Rating of Perceived Exertion will also be re-evaluated at the 4-week and 12-week mark. The health related quality of life will also be used as an outcome measure, using the 12-Item Short Form Survey, at 12 weeks of follow-up. RANDOMISATION Participants will be divided into two groups, standard care and intervention, by means of balanced randomization at a 1:1 ratio using blocks of 10 participants. The randomization sequence is going to be created using a free software ( http://www.randomized.org/ ). In order to ensure the confidentiality of the randomisation sequence, this process will be conducted by an assessor external to the study. BLINDING (MASKING) The evaluators in the study will be blinded during the entire process. The evaluators will be unaware of the study objectives and the randomized distribution of patients to study groups and will not have access to the randomization sequence. Although blinding for patients will not be possible to achieve completely, subjects will be unaware of other treatment modalities, and they will not know if they belong to the intervention or standard group. As for the treating physiotherapists and ICU staff, blinding will not be possible to achieve, but they will not be responsible for assessing outcomes. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) We plan to randomise 40 participants to each group. 80 participants in total. TRIAL STATUS This is the second and definitive protocol version, dated from 26th February 2021. Recruitment started on 8 th March 2021. Participants will be recruited between March 8, 2021, and June 8, 2021. Study completion is expected to be October 2021. TRIAL REGISTRATION ReBEC RBR-7rvhpq9 . Registry name: The effect of rehabilitation in hospitalized COVID-19 patients. Registered on 17 March 2021.Retrospectively registered. FULL PROTOCOL: ""The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol"".",2021,"The need of mechanical ventilation and length of use, as well as the need for oxygen therapy, length of ICU stay (days/hours), incidence of ICU readmission, discharge destination and survival will also be recorded.","['Potential participants will be adult patients (≥18 years old) hospitalized in ICU with respiratory insufficiency due to COVID-19, who are referred to respiratory and functional rehabilitation', 'intensive care unit patients affected by COVID-19', 'Participants will be recruited between March 8, 2021, and June 8, 2021', 'hospitalized COVID-19 patients', '80 participants in total', 'patients affected by hospitalization in Intensive Care Unit (ICU', 'The study will be conducted at Centro Hospitalar Entre Douro e Vouga, Santa Maria da Feira, Portugal']","['functional and respiratory multidisciplinary rehabilitation protocol (that includes medical, nursing, physiotherapy and occupational therapy interventions', 'rehabilitation exercises, prescribed by physical rehabilitation doctors', 'Therapeutic respiratory and functional rehabilitation protocol', 'rehabilitation program']","['Glasgow Coma Scale, Richmond Agitation Sedation Scale, Chelsea Critical Care Physical Assessment, 5 standardized questions for cooperation, Medical Research Council Sum-Score, Handgrip strength test and Medical Research Council dyspnea scale', 'functional capacity using the 6-Minute Walk Test, and it will be measured at discharge', 'oxygen therapy, length of ICU stay (days/hours), incidence of ICU readmission, discharge destination and survival', 'age, sex, comorbidities and date of admission to ICU']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0034088', 'cui_str': 'Pulmonic valve regurgitation'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0454532', 'cui_str': 'Functional rehabilitation'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0032729', 'cui_str': 'Portugal'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0454532', 'cui_str': 'Functional rehabilitation'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C1302393', 'cui_str': 'Date of admission'}]",,0.0641957,"The need of mechanical ventilation and length of use, as well as the need for oxygen therapy, length of ICU stay (days/hours), incidence of ICU readmission, discharge destination and survival will also be recorded.","[{'ForeName': 'Ana Cristina', 'Initials': 'AC', 'LastName': 'Carvalho', 'Affiliation': 'Department of Public Health - USP Porto Oriental, ACES Grande Porto VI, Porto, Portugal. acpcarvalho@arsnorte.min-saude.pt.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Moreira', 'Affiliation': 'Department of Physical and Rehabilitation Medicine - Centro Hospitalar de Entre o Douro e Vouga, Santa Maria da Feira, Portugal.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Cubelo', 'Affiliation': 'Department of Physical and Rehabilitation Medicine - Centro Hospitalar de Entre o Douro e Vouga, Santa Maria da Feira, Portugal.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Cantista', 'Affiliation': 'Department of Physical and Rehabilitation Medicine - Centro Hospitalar Universitário do Porto, Porto, Portugal.'}, {'ForeName': 'Catarina Aguiar', 'Initials': 'CA', 'LastName': 'Branco', 'Affiliation': 'Department of Physical and Rehabilitation Medicine - Centro Hospitalar de Entre o Douro e Vouga, Santa Maria da Feira, Portugal.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Guimarães', 'Affiliation': 'Department of Physical and Rehabilitation Medicine - Centro Hospitalar de Entre o Douro e Vouga, Santa Maria da Feira, Portugal. btsguimaraes@med.up.pt.'}]",Trials,['10.1186/s13063-021-05210-y'] 4077,33845869,Yoga for older adults with multimorbidity (the Gentle Years Yoga Trial): study protocol for a randomised controlled trial.,"BACKGROUND Multimorbidity is common in older adults and associated with high levels of illness burden and healthcare expenditure. The evidence base for how to manage older adults with multimorbidity is weak. Yoga might be a useful intervention because it has the potential to improve health-related quality of life, physical functioning, and several medical conditions. The British Wheel of Yoga's Gentle Years Yoga© (GYY) programme was developed specifically for older adults, including those with chronic medical conditions. Data from a pilot trial suggested feasibility of using GYY in this population, but its effectiveness and cost-effectiveness remain uncertain. METHODS This is a multi-site, individually randomised, superiority trial with an embedded process evaluation and an economic analysis of cost-effectiveness. The trial will compare an experimental strategy of offering a 12-week GYY programme against a control strategy of no offer in community-dwelling adults aged 65 or over who have multimorbidity, defined as having two or more chronic conditions from a predefined list. The primary outcome is health-related quality of life measured using the EQ-5D-5L, the primary endpoint being the overall difference over 12 months. Both groups will continue to be able to access their usual care from primary, secondary, community, and social services. Participants, care providers, and yoga teachers will not be blinded to the allocated intervention. Outcome measures are primarily self-reported. The analysis will follow intention-to-treat principles. DISCUSSION This pragmatic randomised controlled trial will demonstrate if the GYY programme is an effective, cost-effective, and viable addition to the management of older adults with multimorbidity. TRIAL REGISTRATION ISRCTN ISRCTN13567538 . Registered on 18 March 2019.",2021,"Yoga might be a useful intervention because it has the potential to improve health-related quality of life, physical functioning, and several medical conditions.","['older adults, including those with chronic medical conditions', 'older adults', 'community-dwelling adults aged 65 or over who have multimorbidity, defined as having two or more chronic conditions from a predefined list', 'older adults with multimorbidity', 'Participants, care providers, and yoga teachers']","[""Yoga's Gentle Years Yoga© (GYY) programme""]",['health-related quality of life measured using the EQ-5D-5L'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.320897,"Yoga might be a useful intervention because it has the potential to improve health-related quality of life, physical functioning, and several medical conditions.","[{'ForeName': 'Garry A', 'Initials': 'GA', 'LastName': 'Tew', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle-upon-Tyne, UK. garry.tew@northumbria.ac.uk.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bissell', 'Affiliation': 'British Wheel of Yoga Qualifications (BWYQ), Sleaford, Lincs, UK.'}, {'ForeName': 'Belen', 'Initials': 'B', 'LastName': 'Corbacho', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Fairhurst', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Howsam', 'Affiliation': 'British Wheel of Yoga Qualifications (BWYQ), Sleaford, Lincs, UK.'}, {'ForeName': 'Jess', 'Initials': 'J', 'LastName': 'Hugill-Jones', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Maturana', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Shirley-Anne S', 'Initials': 'SS', 'LastName': 'Paul', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Rapley', 'Affiliation': 'Department of Social Work, Education and Community Wellbeing, Northumbria University, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Roche', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Fi', 'Initials': 'F', 'LastName': 'Rose', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Torgerson', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Ward', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Wiley', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Yates', 'Affiliation': 'Department of Anaesthesia, York Hospitals NHS Foundation Trust, York, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hewitt', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}]",Trials,['10.1186/s13063-021-05217-5'] 4078,33845856,"The Early Youth Engagement in first episode psychosis (EYE-2) study: pragmatic cluster randomised controlled trial of implementation, effectiveness and cost-effectiveness of a team-based motivational engagement intervention to improve engagement.","BACKGROUND Early Intervention in Psychosis (EIP) services improve health outcomes for young people with psychosis in the medium-long term, but 25% of young people disengage in the first 12 months with costs to their mental health, families, society and the NHS. This study will evaluate the effectiveness, cost-effectiveness and implementation of a team-based motivational Early Youth Engagement (EYE-2) intervention. METHOD The study design is a cluster randomised controlled trial (RCT) with economic evaluation, comparing the EYE-2 intervention + standardised EIP service to standardised EIP service alone, with randomisation at the team level. A process evaluation will evaluate the delivery of the intervention qualitatively and quantitatively across contexts. The setting is 20 EIP teams in 5 sites: Manchester, South London, East Anglia, Thames Valley and Hampshire. Participants are young people (14-35 years) with first episode psychosis, and EIP staff. The intervention is the team-based motivational engagement (EYE-2) intervention, delivered alongside standardised EIP services, and supported by additional training, website, booklets and social groups. The comparator is the standardised EIP service. Both interventions are delivered by EIP clinicians. The primary outcome is time to disengagement (time in days from date of allocation to care coordinator to date of last contact following refusal to engage with EIP service, or lack of response to EIP contact for a consecutive 3-month period). Secondary outcomes include mental and physical health, deaths, social and occupational function, recovery, satisfaction and service use at 6, 12, 18 and 24 months. A 12-month within-trial economic evaluation will investigate cost-effectiveness from a societal perspective and from an NHS perspective. DISCUSSION The trial will provide the first test of an engagement intervention in standardised care, with the potential for significant impact on the mental health and wellbeing of young people and their families, and economic benefits for services. The intervention will be highly scalable, supported by the toolkit including manuals, commissioning guide, training and resources, adapted to meet the needs of the diverse EIP population, and based on an in-depth process evaluation. TRIAL REGISTRATION ISRCTN 51629746 prospectively registered 7th May 2019. Date assigned 10th May 2019.",2021,"BACKGROUND Early Intervention in Psychosis (EIP) services improve health outcomes for young people with psychosis in the medium-long term, but 25% of young people disengage in the first 12 months with costs to their mental health, families, society and the NHS.","['young people with psychosis', 'Participants are young people (14-35\u2009years) with first episode psychosis, and EIP staff']","['EYE-2 intervention + standardised EIP service to standardised EIP service alone', 'team-based motivational engagement intervention', 'team-based motivational Early Youth Engagement (EYE-2) intervention']","['mental and physical health, deaths, social and occupational function, recovery, satisfaction and service use', 'time to disengagement (time in days from date of allocation to care coordinator to date of last contact following refusal to engage with EIP service, or lack of response to EIP contact']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C1272289', 'cui_str': 'Early intervention in psychosis'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1272289', 'cui_str': 'Early intervention in psychosis'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C4708569', 'cui_str': 'Care coordinator'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0040809', 'cui_str': 'Refusal of treatment by patient'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C1272289', 'cui_str': 'Early intervention in psychosis'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}]",,0.0482064,"BACKGROUND Early Intervention in Psychosis (EIP) services improve health outcomes for young people with psychosis in the medium-long term, but 25% of young people disengage in the first 12 months with costs to their mental health, families, society and the NHS.","[{'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Greenwood', 'Affiliation': 'R&D, Sussex Partnership NHS Foundation Trust, Hove, UK. k.e.greenwood@sussex.ac.uk.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Webb', 'Affiliation': 'School of Psychology, University of Sussex, Falmer, UK.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': 'School of Psychology, University of Sussex, Falmer, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fowler', 'Affiliation': 'R&D, Sussex Partnership NHS Foundation Trust, Hove, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'de Visser', 'Affiliation': 'School of Psychology, University of Sussex, Falmer, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bremner', 'Affiliation': 'Brighton and Sussex Medical School, University of Sussex, Falmer, UK.'}, {'ForeName': 'Iga', 'Initials': 'I', 'LastName': 'Abramowicz', 'Affiliation': 'Brighton and Sussex Medical School, University of Sussex, Falmer, UK.'}, {'ForeName': 'Nicky', 'Initials': 'N', 'LastName': 'Perry', 'Affiliation': 'Brighton and Sussex University Hospitals NHS Trust, Brighton, UK.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Clark', 'Affiliation': 'Sussex Partnership NHS Foundation Trust, Hove, UK.'}, {'ForeName': 'Anastacia', 'Initials': 'A', 'LastName': ""O'Donnell"", 'Affiliation': 'Sussex Partnership NHS Foundation Trust, Hove, UK.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Charlton', 'Affiliation': 'Sussex Partnership NHS Foundation Trust, Hove, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Jarvis', 'Affiliation': 'Sussex Partnership NHS Foundation Trust, Hove, UK.'}, {'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Garety', 'Affiliation': ""King's College London, Institute of Psychiatry Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Nandha', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Lennox', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Johns', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Shanaya', 'Initials': 'S', 'LastName': 'Rathod', 'Affiliation': 'Southern Health NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Phiri', 'Affiliation': 'Southern Health NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'French', 'Affiliation': 'Pennine Care NHS Foundation Trust, Ashton-under-Lyne, UK.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Law', 'Affiliation': 'Greater Manchester Mental Health NHS Foundation Trust, Greater Manchester, UK.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Hodgekins', 'Affiliation': 'University of East Anglia, Norwich, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Painter', 'Affiliation': 'Cambridge and Peterborough NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Cate', 'Initials': 'C', 'LastName': 'Treise', 'Affiliation': 'Cambridge and Peterborough NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Plaistow', 'Affiliation': 'Norfolk and Suffolk NHS Foundation Trust, Norwich, UK.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Irwin', 'Affiliation': 'Norfolk and Suffolk NHS Foundation Trust, Norwich, UK.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Thompson', 'Affiliation': 'McPin Foundation, London, UK.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Mackay', 'Affiliation': 'McPin Foundation, London, UK.'}, {'ForeName': 'Carl R', 'Initials': 'CR', 'LastName': 'May', 'Affiliation': 'Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Healey', 'Affiliation': ""King's College London, Institute of Psychiatry Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hooper', 'Affiliation': 'Institute of Population Health Sciences, Queen Mary University of London, London, UK.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Peters', 'Affiliation': ""King's College London, Institute of Psychiatry Psychology and Neuroscience, London, UK.""}]",Trials,['10.1186/s13063-021-05105-y'] 4079,33845921,A study protocol for the development of a multivariable model predicting 6- and 12-month mortality for people with dementia living in residential aged care facilities (RACFs) in Australia.,"BACKGROUND For residential aged care facility (RACF) residents with dementia, lack of prognostic guidance presents a significant challenge for end of life care planning. In an attempt to address this issue, models have been developed to assess mortality risk for people with advanced dementia, predominantly using long-term care minimum data set (MDS) information from the USA. A limitation of these models is that the information contained within the MDS used for model development was not collected for the purpose of identifying prognostic factors. The models developed using MDS data have had relatively modest ability to discriminate mortality risk and are difficult to apply outside the MDS setting. This study will aim to develop a model to estimate 6- and 12-month mortality risk for people with dementia from prognostic indicators recorded during usual clinical care provided in RACFs in Australia. METHODS A secondary analysis will be conducted for a cohort of people with dementia from RACFs participating in a cluster-randomized trial of a palliative care education intervention (IMPETUS-D). Ten prognostic indicator variables were identified based on a literature review of clinical features associated with increased mortality for people with dementia living in RACFs. Variables will be extracted from RACF files at baseline and mortality measured at 6 and 12 months after baseline data collection. A multivariable logistic regression model will be developed for 6- and 12-month mortality outcome measures using backwards elimination with a fractional polynomial approach for continuous variables. Internal validation will be undertaken using bootstrapping methods. Discrimination of the model for 6- and 12-month mortality will be presented as receiver operating curves with c statistics. Calibration curves will be presented comparing observed and predicted event rates for each decile of risk as well as flexible calibration curves derived using loess-based functions. DISCUSSION The model developed in this study aims to improve clinical assessment of mortality risk for people with dementia living in RACFs in Australia. Further external validation in different populations will be required before the model could be developed into a tool to assist with clinical decision-making in the future.",2020,The models developed using MDS data have had relatively modest ability to discriminate mortality risk and are difficult to apply outside the MDS setting.,"['people with dementia from RACFs participating in a cluster-randomized trial of a', 'people with dementia living in residential aged care facilities (RACFs) in Australia', 'people with dementia living in RACFs in Australia', 'people with advanced dementia', 'people with dementia from prognostic indicators recorded during usual clinical care provided in RACFs in Australia', 'people with dementia living in RACFs']",['palliative care education intervention (IMPETUS-D'],['mortality risk'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C3266593', 'cui_str': 'Palliative care education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.101104,The models developed using MDS data have had relatively modest ability to discriminate mortality risk and are difficult to apply outside the MDS setting.,"[{'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Bicknell', 'Affiliation': 'Department of Medicine and Aged Care, @AgeMelbourne, Melbourne Health-Royal Melbourne Hospital, University of Melbourne, 6 North Main Building, Royal Melbourne Hospital, 300 Grattan Street, Parkville, Victoria, 3050, Australia. Ross.Bicknell@mh.org.au.'}, {'ForeName': 'Wen Kwang', 'Initials': 'WK', 'LastName': 'Lim', 'Affiliation': 'Department of Medicine and Aged Care, @AgeMelbourne, Melbourne Health-Royal Melbourne Hospital, University of Melbourne, 6 North Main Building, Royal Melbourne Hospital, 300 Grattan Street, Parkville, Victoria, 3050, Australia.'}, {'ForeName': 'Andrea B', 'Initials': 'AB', 'LastName': 'Maier', 'Affiliation': 'Department of Medicine and Aged Care, @AgeMelbourne, Melbourne Health-Royal Melbourne Hospital, University of Melbourne, 6 North Main Building, Royal Melbourne Hospital, 300 Grattan Street, Parkville, Victoria, 3050, Australia.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'LoGiudice', 'Affiliation': 'Department of Medicine and Aged Care, @AgeMelbourne, Melbourne Health-Royal Melbourne Hospital, University of Melbourne, 6 North Main Building, Royal Melbourne Hospital, 300 Grattan Street, Parkville, Victoria, 3050, Australia.'}]",Diagnostic and prognostic research,['10.1186/s41512-020-00085-0'] 4080,33845853,Effect of commercial wearables and digital behaviour change resources on the physical activity of adolescents attending schools in socio-economically disadvantaged areas: the RAW-PA cluster-randomised controlled trial.,"BACKGROUND There has been increasing interest in using wearable activity trackers to promote physical activity in youth. This study examined the short- and longer-term effects of a wearable activity tracker combined with digital behaviour change resources on the physical activity of adolescents attending schools in socio-economically disadvantaged areas. METHODS The Raising Awareness of Physical Activity (RAW-PA) Study was a 12-week, multicomponent intervention that combined a Fitbit Flex (and accompanying app), and online digital behaviour change resources and weekly challenges delivered via Facebook. RAW-PA was evaluated using a cluster-randomised controlled trial with 275 adolescents (50.2% female; 13.7 ± 0.4 years) from 18 Melbourne secondary schools (intervention n = 9; wait-list control group n = 9). The primary outcome was moderate- to vigorous-intensity physical activity (MVPA), measured using hip-worn ActiGraph accelerometers. The secondary outcome was self-reported physical activity. Data were collected at baseline, 12-weeks (immediately post-intervention), and 6-months post-intervention (follow-up). Multilevel models were used to determine the effects of the intervention on daily MVPA over time, adjusting for covariates. RESULTS No significant differences were observed between intervention and wait-list control adolescents' device-assessed MVPA immediately post-intervention. At 6-months post-intervention, adolescents in the intervention group engaged in 5 min (95% CI: - 9.1 to - 1.0) less MVPA per day than those in the wait-list control group. Males in the intervention group engaged in 11 min (95% CI: - 17.6 to - 4.5) less MVPA than males in the wait-list control group at 6-months post-intervention. No significant differences were observed for females at either time point. For self-reported physical activity, no significant effects were found at 12-weeks and 6-months post-intervention. CONCLUSIONS Combining a wearable activity tracker with digital behaviour change resources and weekly challenges did not increase inactive adolescents' accelerometer-derived and self-reported physical activity levels immediately post-intervention. This contrasts previous research that has suggested wearable activity tracker may increase youth physical activity levels in the short-term. Lower engagement in MVPA 6-months post-intervention was observed for males but not for females, though it is unclear why this finding was observed. The results suggest wearable activity trackers, in combination with supporting materials, may not be effective for increasing physical activity levels in adolescents. TRIAL REGISTRATION ACTRN12616000899448 . Australian and New Zealand Clinical Trials Registry. Registered 7 July 2016.",2021,No significant differences were observed between intervention and wait-list control adolescents' device-assessed MVPA immediately post-intervention.,"['adolescents attending schools in socio-economically disadvantaged areas', 'adolescents', '275 adolescents (50.2% female; 13.7\u2009±\u20090.4\u2009years) from 18 Melbourne secondary schools (intervention n\u2009=\u20099; wait-list control group n\u2009=\u20099']","['MVPA', 'commercial wearables and digital behaviour change resources', 'wearable activity tracker combined with digital behaviour change resources', 'multicomponent intervention that combined a Fitbit Flex (and accompanying app), and online digital behaviour change resources and weekly challenges delivered via Facebook']","[""inactive adolescents' accelerometer-derived and self-reported physical activity levels"", 'physical activity levels', 'moderate- to vigorous-intensity physical activity (MVPA), measured using hip-worn ActiGraph accelerometers', 'self-reported physical activity', 'Physical Activity (RAW-PA', 'youth physical activity levels']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0557295', 'cui_str': 'School attendance - finding'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]",275.0,0.0280556,No significant differences were observed between intervention and wait-list control adolescents' device-assessed MVPA immediately post-intervention.,"[{'ForeName': 'Nicola D', 'Initials': 'ND', 'LastName': 'Ridgers', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia. nicky.ridgers@deakin.edu.au.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Timperio', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Ball', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}, {'ForeName': 'Samuel K', 'Initials': 'SK', 'LastName': 'Lai', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Brown', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}, {'ForeName': 'Susie', 'Initials': 'S', 'LastName': 'Macfarlane', 'Affiliation': 'Learning Futures, Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Salmon', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-021-01110-1'] 4081,33845863,A stepped wedge cluster randomized control trial to evaluate the implementation and effectiveness of optimized initiatives in improving quality of care for ST segment elevation myocardial infarction in response to the COVID-19 outbreak.,"BACKGROUND The National Chest Pain Center Accreditation Program (CHANGE) is the first hospital-based, multifaceted, nationwide quality improvement (QI) initiative, to monitor and improve the quality of the ST segment elevation myocardial infarction (STEMI) care in China. The QI initiatives, as implementation strategies, include a bundle of evidence-based interventions adapted for implementation in China. During the pandemic of coronavirus disease 2019 (COVID-19), fear of infection with severe acute respiratory syndrome coronavirus 2, national lockdowns, and altered health care priorities have highlighted the program's importance in improving STEMI care quality. This study aims to minimize the adverse impact of the COVID-19 pandemic on the quality of STEMI care, by developing interventions that optimize the QI initiatives, implementing and evaluating the optimized QI initiatives, and developing scale-up activities of the optimized QI initiatives in response to COVID-19 and other public health emergencies. METHODS A stepped wedge cluster randomized control trial will be conducted in three selected cities of China: Wuhan, Suzhou, and Shenzhen. Two districts have been randomly selected in each city, yielding a total of 24 registered hospitals. This study will conduct a rollout in these hospitals every 3 months. The 24 hospitals will be randomly assigned to four clusters, and each cluster will commence the intervention (optimized QI initiatives) at one of the four steps. We will conduct hospital-based assessments, questionnaire surveys among health care providers, community-based household surveys, and key informant interviews during the trial. All outcome measures will be organized using the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework, including implementation outcomes, service outcomes (e.g., treatment time), and patient outcomes (e.g., in-hospital mortality and 1-year complication). The Consolidated Framework for Implementation Research framework will be used to identify factors that influence implementation of the optimized QI interventions. DISCUSSION The study findings could be translated into a systematic solution to implementing QI initiatives in response to COVID-19 and future potential major public health emergencies. Such actionable knowledge is critical for implementors of scale-up activities in low- and middle-income settings. TRIAL REGISTRATION ChiCTR 2100043319 . Registered on 10 February 2021.",2021,"During the pandemic of coronavirus disease 2019 (COVID-19), fear of infection with severe acute respiratory syndrome coronavirus 2, national lockdowns, and altered health care priorities have highlighted the program's importance in improving STEMI care quality.","['24 hospitals', 'three selected cities of China: Wuhan, Suzhou, and Shenzhen', 'Two districts have been randomly selected in each city, yielding a total of 24 registered hospitals']",[],"['RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework, including implementation outcomes, service outcomes (e.g., treatment time), and patient outcomes (e.g., in-hospital mortality and 1-year complication']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]",[],"[{'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0743032,"During the pandemic of coronavirus disease 2019 (COVID-19), fear of infection with severe acute respiratory syndrome coronavirus 2, national lockdowns, and altered health care priorities have highlighted the program's importance in improving STEMI care quality.","[{'ForeName': 'Shuduo', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Department of Global Health, School of Public Health, Peking University, 38 Xue Yuan Road, Haidian District, Beijing, 100191, China.'}, {'ForeName': 'Xuejie', 'Initials': 'X', 'LastName': 'Dong', 'Affiliation': 'Department of Global Health, School of Public Health, Peking University, 38 Xue Yuan Road, Haidian District, Beijing, 100191, China.'}, {'ForeName': 'Fangjing', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Global Health, School of Public Health, Peking University, 38 Xue Yuan Road, Haidian District, Beijing, 100191, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Institute of Cardiovascular Disease, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Dahai', 'Initials': 'D', 'LastName': 'Yue', 'Affiliation': 'University of Maryland, College Park, USA.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Shenzhen Center for Prehospital Care, Shenzhen, China.'}, {'ForeName': 'Yinzi', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'Department of Global Health, School of Public Health, Peking University, 38 Xue Yuan Road, Haidian District, Beijing, 100191, China. yzjin@bjmu.edu.cn.'}, {'ForeName': 'Zhi-Jie', 'Initials': 'ZJ', 'LastName': 'Zheng', 'Affiliation': 'Department of Global Health, School of Public Health, Peking University, 38 Xue Yuan Road, Haidian District, Beijing, 100191, China.'}]",Implementation science : IS,['10.1186/s13012-021-01107-1'] 4082,33845819,Transforaminal epidural steroid injection combined with radio frequency for the treatment of lumbar disc herniation: a 2-year follow-up.,"BACKGROUND To assess the therapeutic efficacy of transforaminal epidural steroid injection (TFESI) combined with radio frequency (RF) for the treatment of lumbar disc herniation (LDH). METHODS A total of 230 patients participated in the study: TFESI (Group T, n = 110), TFESI combined with RF (Group TR, n = 120). Visual analogue scale (VAS), Oswestry disability index (ODI) and Global perceived effect (GPE) scale were measured pre-operation, 1, 3, 6, 12 and 24 months after the operation. Hospitalization time, treatment time, complications, and recurrence were compared between the two groups. RESULTS The VAS and ODI at each observation point of the post-operation were significantly decreased compared with the pre-operation in both groups (P < 0.05). There was no statistically difference of VAS and ODI between the two groups at 1 and 3 months of the post-operation (P > 0.05). However, The VAS and ODI scores in Group TR were significantly lower than that in Group T at 6, 12 and 24 months of the post-operation (P < 0.05). The GPE in group TR was high in the early days, while that at 1 and 3 months after treatment was significantly higher than that in group T (P < 0.05). The recurrence rate in Group TR was lower than that in Group T (P = 0.002). There was no significant difference in hospitalization time, complications, VAS and ODI score at the pre-operation between the two groups (P > 0.05). CONCLUSION These findings suggest that TFESI combined with RF could effectively improve the pain and function, and had a long-term satisfactory effect for the treatment of LDH.",2021,The VAS and ODI at each observation point of the post-operation were significantly decreased compared with the pre-operation in both groups (P < 0.05).,"['lumbar disc herniation (LDH', '230 patients participated in the study', 'lumbar disc herniation']","['Transforaminal epidural steroid injection combined with radio frequency', 'TFESI combined with RF', 'TFESI', 'transforaminal epidural steroid injection (TFESI) combined with radio frequency (RF']","['pain and function', 'recurrence rate', 'Visual analogue scale (VAS), Oswestry disability index (ODI) and Global perceived effect (GPE) scale', 'VAS and ODI scores', 'Hospitalization time, treatment time, complications, and recurrence', 'VAS and ODI', 'hospitalization time, complications, VAS and ODI score']","[{'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0196394', 'cui_str': 'Epidural steroid injection'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0034546', 'cui_str': 'Radio'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2960603', 'cui_str': 'Oswestry disability index score'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",230.0,0.0115928,The VAS and ODI at each observation point of the post-operation were significantly decreased compared with the pre-operation in both groups (P < 0.05).,"[{'ForeName': 'Wen-Bo', 'Initials': 'WB', 'LastName': 'Wei', 'Affiliation': ""The Key Laboratory of Biomedical Information Engineering of Ministry of Education, The Key Laboratory of Neuro-informatics & Rehabilitation Engineering of Ministry of Civil Affairs, and Institute of Health and Rehabilitation Science, School of Life Science and Technology, Xi'an Jiaotong University, Xi'an, 710049, P. R. China.""}, {'ForeName': 'Sha-Jie', 'Initials': 'SJ', 'LastName': 'Dang', 'Affiliation': ""The Key Laboratory of Biomedical Information Engineering of Ministry of Education, The Key Laboratory of Neuro-informatics & Rehabilitation Engineering of Ministry of Civil Affairs, and Institute of Health and Rehabilitation Science, School of Life Science and Technology, Xi'an Jiaotong University, Xi'an, 710049, P. R. China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': 'Department of Pain, YangLing Demonstration Zone Hospital, Yangling, Shaanxi, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': ""The Key Laboratory of Biomedical Information Engineering of Ministry of Education, The Key Laboratory of Neuro-informatics & Rehabilitation Engineering of Ministry of Civil Affairs, and Institute of Health and Rehabilitation Science, School of Life Science and Technology, Xi'an Jiaotong University, Xi'an, 710049, P. R. China. tianliu@xjtu.edu.cn.""}, {'ForeName': 'Jue', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""The Key Laboratory of Biomedical Information Engineering of Ministry of Education, The Key Laboratory of Neuro-informatics & Rehabilitation Engineering of Ministry of Civil Affairs, and Institute of Health and Rehabilitation Science, School of Life Science and Technology, Xi'an Jiaotong University, Xi'an, 710049, P. R. China. juewang_xjtu@126.com.""}]",BMC musculoskeletal disorders,['10.1186/s12891-021-04209-5'] 4083,33845783,Preoperative X-ray C 2 C 6 AR is applicable for prediction of difficult laryngoscopy in patients with cervical spondylosis.,"BACKGROUND Airway management is one of the most important techniques in anesthesia practice and inappropriate airway management is related with airway injury, brain hypoxia, and even death. The patients with cervical spondylosis are often confronted with difficult laryngoscopy who are more prone to appear difficult airway, so it is important to figure out valuable predictors of difficult laryngoscopy in these patients. METHODS We randomly enrolled 270 patients undergoing elective cervical spine surgery and analyzed the cervical mobility data in predicting difficult laryngoscopy. The preoperative X-ray radiological indicators were measured by an attending radiologist. Cormack-Lehane scales were assessed during intubation, and patients with a class III or IV view were assigned to the difficult laryngoscopy group. RESULTS Univariate analysis showed that the hyomental distance (HMD, the distance between the hyoid bone and the tip of the chin) and the hyomental distance ratio (HMDR, the ratio between HMD in the extension position and the one in the neutral position) might not be suitable indicators in patients with cervical spondylosis. Binary multivariate logistic regression (backward-Wald) analyses identified two independent correlative factors from the cervical mobility indicators that correlated best as a predictor of difficult laryngoscopy: modified Mallampati test (MMT) and C 2 C 6 AR (the ratio of the angle between a line passing through the bottom of the second cervical vertebra and a line passing through the bottom of the sixth cervical vertebra in the extension position and the one in the neutral position). The odds ratio (OR) and 95 % CI were 2.292(1.093-4.803) and 0.493 (0.306-0.793), respectively. C 2 C 6 AR exhibited the largest area under the curve (0.714; 95 % CI 0.633-0.794). CONCLUSIONS C 2 C 6 AR based on preoperative X-ray images may be the most accurate predictor of cervical mobility indicators for difficult laryngoscopy in patients with cervical spondylosis. TRIAL REGISTRATION The study was registered at the Chinese Clinical Trial Registry ( http://www.chictr.org.cn ; identifier: ChiCTR-ROC-16,008,598) on June 6, 2016.",2021,"C 2 C 6 AR exhibited the largest area under the curve (0.714; 95 % CI 0.633-0.794). ","['270 patients undergoing elective cervical spine surgery and analyzed the cervical mobility data in predicting difficult laryngoscopy', 'patients with cervical spondylosis']",[],"['Cormack-Lehane scales', 'hyomental distance (HMD, the distance between the hyoid bone and the tip of the chin) and the hyomental distance ratio (HMDR', 'preoperative X-ray radiological indicators']","[{'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C1384641', 'cui_str': 'Cervical spondylosis'}]",[],"[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0030072', 'cui_str': 'Oxymetholone'}, {'cui': 'C0020417', 'cui_str': 'Hyoid bone structure'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0008114', 'cui_str': 'Chin structure'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",270.0,0.0657749,"C 2 C 6 AR exhibited the largest area under the curve (0.714; 95 % CI 0.633-0.794). ","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, Peking University Third Hospital, Peking University Health Science Center, 49 North Garden Road, Haidian District, Beijing, P.R. China.'}, {'ForeName': 'Yongzheng', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Anesthesiology, Peking University Third Hospital, Peking University Health Science Center, 49 North Garden Road, Haidian District, Beijing, P.R. China.'}, {'ForeName': 'Zhengqian', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Peking University Third Hospital, Peking University Health Science Center, 49 North Garden Road, Haidian District, Beijing, P.R. China.'}, {'ForeName': 'Yuqing', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Radiology, Peking University Third Hospital, Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Peking University Third Hospital, Peking University Health Science Center, 49 North Garden Road, Haidian District, Beijing, P.R. China.'}, {'ForeName': 'Taotao', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Peking University Third Hospital, Peking University Health Science Center, 49 North Garden Road, Haidian District, Beijing, P.R. China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Peking University Third Hospital, Peking University Health Science Center, 49 North Garden Road, Haidian District, Beijing, P.R. China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Peking University Third Hospital, Peking University Health Science Center, 49 North Garden Road, Haidian District, Beijing, P.R. China.'}, {'ForeName': 'Xiangyang', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Department of Anesthesiology, Peking University Third Hospital, Peking University Health Science Center, 49 North Garden Road, Haidian District, Beijing, P.R. China. puthmzk@hsc.pku.edu.cn.'}, {'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, Peking University Third Hospital, Peking University Health Science Center, 49 North Garden Road, Haidian District, Beijing, P.R. China. anae@163.com.'}]",BMC anesthesiology,['10.1186/s12871-021-01335-4'] 4084,33845780,"Correction to: Induction techniques that reduce redistribution hypothermia: a prospective, randomized, controlled, single blind effectiveness study.",,2021,,[],[],['redistribution hypothermia'],[],[],"[{'cui': 'C0332620', 'cui_str': 'Redistribution'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}]",,0.0119807,,"[{'ForeName': 'Jonathan V', 'Initials': 'JV', 'LastName': 'Roth', 'Affiliation': 'Department of Anesthesiology, Albert Einstein Medical Center, 5501 Old York Road, Philadelphia, PA, USA. jvroth1@aol.com.'}, {'ForeName': 'Leonard E', 'Initials': 'LE', 'LastName': 'Braitman', 'Affiliation': 'Office for Research and Technology Development, Albert Einstein Medical Center, 5501 Old York Road, Philadelphia, PA, USA.'}, {'ForeName': 'Lacy H', 'Initials': 'LH', 'LastName': 'Hunt', 'Affiliation': 'Office for Research and Technology Development, Albert Einstein Medical Center, 5501 Old York Road, Philadelphia, PA, USA.'}]",BMC anesthesiology,['10.1186/s12871-021-01327-4'] 4085,33845761,"Dexmedetomidine decreased the post-thyroidectomy bleeding by reducing cough and emergence agitation - a randomized, double-blind, controlled study.","BACKGROUND Bleeding after thyroidectomy occurs due to violent coughing during emergence. Dexmedetomidine is helpful for the smooth emergence and suppression of cough. The purpose of the present study was to compare the effects of dexmedetomidine on postoperative bleeding after thyroidectomy. METHODS Randomized, double-blind, controlled trials were conducted in female patients (ASA I-II, aged 20 to 60 years). The patients were randomly allocated into two groups. Approximately 15 min before the end of the surgery, dexmedetomidine was administered (0.6 µg/kg/h) without a loading dose in group D (n = 69), and normal saline was administered in group S (n = 70) at the same infusion rate. Hemodynamic data, coughing reflex, extubation time, Ramsay sedation scale (RSS), and recovery time were assessed during the administration of the study drugs and recovery from anesthesia. The amount of postoperative hemorrhage was measured for 3 days. RESULTS Data from a total of 139 patients were analyzed. The incidence of severe cough was significantly lower in group D than in group S (4.3 % vs. 11.5 %, P = 0.022). The emergence agitation in the postanesthetic care unit was significantly lower in group D than in group S (P = 0.01). Postoperative bleeding was significantly lower in group D than in group S until the second postoperative day (P = 0.015). CONCLUSIONS Dexmedetomidine can be helpful in decreasing bleeding after thyroidectomy by reducing coughing and emergence agitation. TRIAL REGISTRATION This study was registered at http://clinicaltrials.gov (registration number NCT02412150, 09/04/2015).",2021,"Postoperative bleeding was significantly lower in group D than in group S until the second postoperative day (P = 0.015). ","['Data from a total of 139 patients were analyzed', 'female patients (ASA I-II, aged 20 to 60 years']","['Dexmedetomidine', 'normal saline', 'dexmedetomidine']","['incidence of severe cough', 'emergence agitation', 'postoperative hemorrhage', 'Hemodynamic data, coughing reflex, extubation time, Ramsay sedation scale (RSS), and recovery time', 'Postoperative bleeding', 'postoperative bleeding']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0920253', 'cui_str': 'Agitated Emergence'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0232051', 'cui_str': 'Cough reflex'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0559295', 'cui_str': 'Ramsay sedation scale'}]",139.0,0.317123,"Postoperative bleeding was significantly lower in group D than in group S until the second postoperative day (P = 0.015). ","[{'ForeName': 'Sang Hun', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chosun University Hospital, 365 Pilmun-dearo, Donggu, 61453, Gwangju, Korea.'}, {'ForeName': 'Yoo Seok', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Chosun University College of Medicine, Chosun University Hospital, Gwangju, Korea.'}, {'ForeName': 'Seongcheol', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chosun University Hospital, 365 Pilmun-dearo, Donggu, 61453, Gwangju, Korea.'}, {'ForeName': 'Ki Tae', 'Initials': 'KT', 'LastName': 'Jung', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chosun University Hospital, 365 Pilmun-dearo, Donggu, 61453, Gwangju, Korea. mdmole@chosun.ac.kr.'}]",BMC anesthesiology,['10.1186/s12871-021-01325-6'] 4086,33845710,Melatonin supplementation improves psychomotor and physical performance in collegiate student-athletes following a sleep deprivation night.,"Several studies report sleep deprivation negatively impacts post-cognitive and physical performance, and other functions. Recent findings indicate ingestion of melatonin prior to exercise enhances tolerance to training and improves competition. We investigated the effects of melatonin supplementation on psychomotor performance and selected physical fitness measures of collegiate student-athletes following 4 h and 24 h of sleep deprivation. The study employed a repeated-measures, double-blind, randomized controlled protocol with posttest control group design with six conditions [3 sleep conditions (without sleep deprivation, 4 h sleep deprivation (4SD) and 24 h sleep deprivation (24SD)) × 2 supplementation conditions (melatonin and placebo)]. Ten trained male collegiate student-athletes (mean ± SD; age: 20 ± 2 y) attended the laboratory on six occasions with 72 h between successive visits. Placebo or 6 mg of melatonin were administered orally in capsules 30 min before the tests of: static and dynamic balance, reaction time, and anaerobic power. Also, blood lactate was measured before and 3 min after the anaerobic power exercise. During the placebo session, the results indicated that 4SD and 24SD had negative effect on the measured parameters, with higher impacts of the 24SD condition. Compared to placebo and during both 4SD and 24SD conditions, melatonin had a positive effect on static and dynamic balance, anaerobic power, blood lactic acid, and reaction time ( p < .05). However, 6 mg melatonin ingestion had no significant effect on all dependent variables in collegiate student-athletes after the night without a sleep deprivation ( p > .05). In conclusion, 6 mg of melatonin may be used by student-athletes to improve balance and psychomotor and physical performances after 4 h or 24 h of sleep deprivation.",2021,"Compared to placebo and during both 4SD and 24SD conditions, melatonin had a positive effect on static and dynamic balance, anaerobic power, blood lactic acid, and reaction time ( p < .05).","['collegiate student-athletes following 4\xa0h and 24\xa0h of sleep deprivation', 'Ten trained male collegiate student-athletes (mean ± SD; age: 20\xa0±\xa02 y) attended the laboratory on six occasions with 72\xa0h between successive visits', 'collegiate student-athletes following a sleep deprivation night']","['melatonin', 'melatonin supplementation', 'Melatonin supplementation', 'six conditions [3 sleep conditions (without sleep deprivation, 4\xa0h sleep deprivation (4SD) and 24\xa0h sleep deprivation (24SD', 'placebo', 'Placebo', 'supplementation conditions (melatonin and placebo']","['psychomotor performance and selected physical fitness measures', 'psychomotor and physical performance', 'blood lactate', 'collegiate student-athletes after the night without a sleep deprivation', 'static and dynamic balance, anaerobic power, blood lactic acid, and reaction time', 'balance and psychomotor and physical performances']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033923', 'cui_str': 'Psychomotor Performance'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0853170', 'cui_str': 'Blood lactic acid'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",10.0,0.145658,"Compared to placebo and during both 4SD and 24SD conditions, melatonin had a positive effect on static and dynamic balance, anaerobic power, blood lactic acid, and reaction time ( p < .05).","[{'ForeName': 'Nesa', 'Initials': 'N', 'LastName': 'Paryab', 'Affiliation': 'Department of Sport Sciences, Faculty of Social Sciences, Imam Khomeini International University, Qazvin, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Taheri', 'Affiliation': 'Department of Sport Sciences, Faculty of Social Sciences, Imam Khomeini International University, Qazvin, Iran.'}, {'ForeName': 'Cyrine', 'Initials': 'C', 'LastName': ""H'Mida"", 'Affiliation': 'High Institute of Sport and Physical Education, University of Sfax, Sfax 3000, Tunisia.'}, {'ForeName': 'Khadijah', 'Initials': 'K', 'LastName': 'Irandoust', 'Affiliation': 'Department of Sport Sciences, Faculty of Social Sciences, Imam Khomeini International University, Qazvin, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Mirmoezzi', 'Affiliation': 'Faculty of Physical Education and Sport Science, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Trabelsi', 'Affiliation': 'High Institute of Sport and Physical Education, University of Sfax, Sfax 3000, Tunisia.'}, {'ForeName': 'Achraf', 'Initials': 'A', 'LastName': 'Ammar', 'Affiliation': 'Institute of Sport Sciences, Otto-von-Guericke University, Magdeburg, Germany.'}, {'ForeName': 'Hamdi', 'Initials': 'H', 'LastName': 'Chtourou', 'Affiliation': 'High Institute of Sport and Physical Education, University of Sfax, Sfax 3000, Tunisia.'}]",Chronobiology international,['10.1080/07420528.2021.1889578'] 4087,33845669,The Effect of Frames on Personal Narratives of Bullying Memories.,"Research demonstrates the malleability of memory; a dynamic process that occurs across development and can be influenced by internal and external frames. Narratives of past experiences represent one modality of understanding how memories are influenced by these frames. The present experimental study examines how memories of bullying are affected by two distinct yet common cultural frames. College students ( n  = 92) were randomly assigned to one of two groups; one with a definition of bullying framing the experience in terms of resilience and one framing it in terms of negative psychosocial effects. Participants then wrote about a remembered experience with bullying. The researchers coded the narratives for coping strategies used in response to bullying as well as for positive or negative emotion words and story endings. The results demonstrated statistically significant differences between groups in the ways bullying experiences were remembered and described. Participants in the Resiliency Group more often had positive endings to their bullying narratives and used more coping skills and positive emotion words overall. The implications of a subtle frame influencing memories of bullying and its relation to development, identity, social order, peer relationships, and resilience are discussed.",2021,Participants in the Resiliency Group more often had positive endings to their bullying narratives and used more coping skills and positive emotion words overall.,"['Participants then wrote about a remembered experience with bullying', 'College students ( n \u2009=\u200992']",[],"['positive endings to their bullying narratives and used more coping skills and positive emotion words overall', 'Personal Narratives of Bullying Memories']","[{'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0424318', 'cui_str': 'Bullying'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",[],"[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0600664', 'cui_str': 'Personal Narratives'}, {'cui': 'C0424318', 'cui_str': 'Bullying'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",92.0,0.0296331,Participants in the Resiliency Group more often had positive endings to their bullying narratives and used more coping skills and positive emotion words overall.,"[{'ForeName': 'Abigail M', 'Initials': 'AM', 'LastName': 'Stark', 'Affiliation': 'Psychology Department, 1850Suffolk University, Boston, MA, USA.'}, {'ForeName': 'Olivia H', 'Initials': 'OH', 'LastName': 'Tousignant', 'Affiliation': 'Psychology Department, 1850Suffolk University, Boston, MA, USA.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Fireman', 'Affiliation': 'Psychology Department, 1850Suffolk University, Boston, MA, USA.'}]",Psychological reports,['10.1177/00332941211006343'] 4088,33845654,Healthcare professionals' views of the use of oral morphine and transmucosal diamorphine in the management of paediatric breakthrough pain and the feasibility of a randomised controlled trial: A focus group study (DIPPER).,"BACKGROUND Oral morphine is frequently used for breakthrough pain but the oral route is not always available and absorption is slow. Transmucosal diamorphine is administered by buccal, sublingual or intranasal routes, and rapidly absorbed. AIM To explore the perspectives of healthcare professionals in the UK caring for children with life-limiting conditions concerning the assessment and management of breakthrough pain; prescribing and administration of transmucosal diamorphine compared with oral morphine; and the feasibility of a comparative clinical trial. DESIGN/ PARTICIPANTS Three focus groups, analysed using a Framework approach. Doctors, nurses and pharmacists ( n  = 28), caring for children with life-limiting illnesses receiving palliative care, participated. RESULTS Oral morphine is frequently used for breakthrough pain across all settings; with transmucosal diamorphine largely limited to use in hospices or given by community nurses, predominantly buccally. Perceived advantages of oral morphine included confidence in its use with no requirement for specific training; disadvantages included tolerability issues, slow onset, unpredictable response and unsuitability for patients with gastrointestinal failure. Perceived advantages of transmucosal diamorphine were quick onset and easy administration; barriers included lack of licensed preparations and prescribing guidance with fears over accountability of prescribers, and potential issues with availability, preparation and palatability. Factors potentially affecting recruitment to a trial were patient suitability and onerousness for families, trial design and logistics, staff time and clinician engagement. CONCLUSIONS There were perceived advantages to transmucosal diamorphine, but there is a need for access to a safe preparation. A clinical trial would be feasible provided barriers were overcome.",2021,"There were perceived advantages to transmucosal diamorphine, but there is a need for access to a safe preparation.","['Doctors, nurses and pharmacists ( n \u2009=\u200928), caring for children with life-limiting illnesses receiving palliative care, participated', 'patients with gastrointestinal failure']","['morphine and transmucosal diamorphine', 'oral morphine', 'transmucosal diamorphine', 'morphine', 'diamorphine', 'Transmucosal diamorphine']",[],"[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0349411', 'cui_str': 'Pangastrointestinal system dysfunction'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C1513727', 'cui_str': 'Transmucosal route'}, {'cui': 'C0011892', 'cui_str': 'Heroin'}, {'cui': 'C0360457', 'cui_str': 'Morphine-containing product in oral dose form'}]",[],,0.103188,"There were perceived advantages to transmucosal diamorphine, but there is a need for access to a safe preparation.","[{'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Jamieson', 'Affiliation': 'Research Department of Practice and Policy, University College London School of Pharmacy, London, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Harrop', 'Affiliation': 'Helen & Douglas House Hospice, Oxford, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Johnson', 'Affiliation': 'Patient & Public Representative c/o Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Liossi', 'Affiliation': 'School of Psychology, University of Southampton, Southampton, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Mott', 'Affiliation': 'Hummingbird House Hospice, Brisbane, Queensland, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Oulton', 'Affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK.'}, {'ForeName': 'Simon S', 'Initials': 'SS', 'LastName': 'Skene', 'Affiliation': 'Surrey Clinical Trials Unit, University of Surrey, Surrey, UK.'}, {'ForeName': 'Ian Ck', 'Initials': 'IC', 'LastName': 'Wong', 'Affiliation': 'Research Department of Practice and Policy, University College London School of Pharmacy, London, UK.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Howard', 'Affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK.'}]",Palliative medicine,['10.1177/02692163211008737'] 4089,33845640,Effect of a three-piece inflatable penile prosthesis combined with a phosphodiesterase-5 inhibitor on erectile dysfunction.,"OBJECTIVE To investigate the therapeutic effect of implanting a three-piece inflatable penile prosthesis (IPP) combined with the phosphodiesterase-5 inhibitor sildenafil in severe erectile dysfunction (ED) patients. METHODS This randomized controlled study included 123 ED patients. Sixty-two patients received the IPP implantation and 61 patients received the IPP implantation and the phosphodiesterase-5 inhibitor sildenafil. Erectile function and sexual life quality were evaluated using the five-item International Index of Erectile Function (IIEF) and modified Sexual Life Quality Questionnaire-Quality of Life domain (mSLQQ-QoL), respectively. Serum interleukin (IL)-6, IL-8, tumor necrosis factor (TNF)-α, vascular cell adhesion molecule (VCAM)-1, and intercellular adhesion molecule (ICAM)-1 levels were assessed. Kaplan-Meier curves were used to assess the overall IPP survival. RESULTS Implantation of the three-piece IPP with sildenafil improved erectile function and sexual life quality, alleviated the inflammatory response, reduced the complication rate, and improved overall IPP survival. CONCLUSION Implantation of the three-piece IPP combined with a phosphodiesterase-5 inhibitor significantly improved clinical outcomes and the prognosis in ED patients.",2021,"RESULTS Implantation of the three-piece IPP with sildenafil improved erectile function and sexual life quality, alleviated the inflammatory response, reduced the complication rate, and improved overall IPP survival. ","['ED patients', 'severe erectile dysfunction (ED) patients', '123 ED patients']","['IPP implantation', 'sildenafil', 'phosphodiesterase-5 inhibitor', 'implanting a three-piece inflatable penile prosthesis (IPP) combined with the phosphodiesterase-5 inhibitor sildenafil', 'phosphodiesterase-5 inhibitor sildenafil']","['erectile dysfunction', 'overall IPP survival', 'Serum interleukin (IL)-6, IL-8, tumor necrosis factor (TNF)-α, vascular cell adhesion molecule (VCAM)-1, and intercellular adhesion molecule (ICAM)-1 levels', 'inflammatory response', 'complication rate, and improved overall IPP survival', 'erectile function and sexual life quality', 'five-item International Index of Erectile Function (IIEF) and modified Sexual Life Quality Questionnaire-Quality of Life domain (mSLQQ-QoL', 'clinical outcomes', 'Erectile function and sexual life quality']","[{'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0182504', 'cui_str': 'Inflatable penile prosthesis'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C1318700', 'cui_str': 'Phosphodiesterase 5 inhibitor'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0182504', 'cui_str': 'Inflatable penile prosthesis'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0242565', 'cui_str': 'Intercellular Adhesion Molecules'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",123.0,0.13074,"RESULTS Implantation of the three-piece IPP with sildenafil improved erectile function and sexual life quality, alleviated the inflammatory response, reduced the complication rate, and improved overall IPP survival. ","[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Urology, the Second People's Hospital of Nantong City, Nantong City, Jiangsu Province, China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Wu', 'Affiliation': ""Department of Urology, the Second People's Hospital of Nantong City, Nantong City, Jiangsu Province, China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': ""Department of Urology, the Second People's Hospital of Nantong City, Nantong City, Jiangsu Province, China.""}, {'ForeName': 'Liangliang', 'Initials': 'L', 'LastName': 'Ben', 'Affiliation': ""Department of Urology, the Second People's Hospital of Nantong City, Nantong City, Jiangsu Province, China.""}, {'ForeName': 'Geng', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': ""Department of Urology, the Second People's Hospital of Nantong City, Nantong City, Jiangsu Province, China.""}, {'ForeName': 'Zhijuan', 'Initials': 'Z', 'LastName': 'Han', 'Affiliation': ""Department of Urology, the Second People's Hospital of Nantong City, Nantong City, Jiangsu Province, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Peng', 'Affiliation': ""Department of Urology, the Second People's Hospital of Nantong City, Nantong City, Jiangsu Province, China.""}]",The Journal of international medical research,['10.1177/0300060520985365'] 4090,33845211,Avelumab vs docetaxel in patients with platinum-treated advanced non-small-cell lung cancer: 2-year follow-up from the JAVELIN Lung 200 phase 3 trial.,"INTRODUCTION In the JAVELIN Lung 200 trial, avelumab (anti-PD-L1 antibody) did not significantly prolong overall survival (OS) vs docetaxel in patients with platinum-treated PD-L1+ NSCLC. We report >2-year follow-up data. METHODS Patients with stage IIIB/IV or recurrent NSCLC with disease progression following platinum-doublet chemotherapy were randomized 1:1 to avelumab 10 mg/kg every 2 weeks or docetaxel 75 mg/m 2 every 3 weeks. The primary endpoint was OS in patients with PD-L1+ tumors (≥1% tumor cell expression; IHC 73-10 pharmDx assay). RESULTS Of 792 patients, 529 had PD-L1+ tumors (264 vs 265 in the avelumab vs docetaxel arms, respectively). As of March 4, 2019, median duration of follow-up for OS in the PD-L1+ population was 35.4 months in the avelumab arm and 34.7 months in the docetaxel arm; study treatment was ongoing in 25 (9.5%) vs 0 patients, respectively. In the PD-L1+ population, 2-year OS rates (95% CI) with avelumab vs docetaxel were 29.9% (24.5%-35.5%) vs 20.5% (15.6%-25.8%); in ≥50% PD-L1+ subgroups, 2-year OS rates were 36.4% (29.1%-43.7%) vs 17.7% (11.8%-24.7%), and in the ≥80% subgroup were 40.2% (31.3%-49.0%) vs 20.3% (12.9%-28.8%), respectively. Median duration of response (investigator assessed) was 19.1 months (95% CI: 10.8-34.8) vs 5.7 months (95% CI: 4.1-8.3). Safety profiles for both arms were consistent with the primary analysis. CONCLUSIONS Although the JAVELIN Lung 200 primary analysis (reported previously) showed that avelumab did not significantly prolong OS vs docetaxel in patients with platinum-treated PD-L1+ NSCLC, post hoc analyses at 2 years of follow-up showed that 2-year OS rates were doubled with avelumab in subgroups with higher PD-L1 expression (≥50% and ≥80%).",2021,Median duration of response (investigator assessed) was 19.1 months (95% CI: 10.8-34.8) vs 5.7 months (95% CI: 4.1-8.3).,"['patients with platinum-treated advanced non-small-cell lung cancer', 'Patients with stage IIIB/IV or recurrent NSCLC with disease progression following platinum-doublet chemotherapy', '792 patients', 'patients with platinum-treated PD-L1+ NSCLC']","['avelumab vs docetaxel', 'PD-L1', 'avelumab 10 mg/kg every 2 weeks or docetaxel', 'Avelumab vs docetaxel', 'docetaxel']","['Median duration of response', 'Safety profiles', '2-year OS rates', 'median duration of follow-up for OS', 'overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C0278517', 'cui_str': 'Non-small cell lung cancer recurrent'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}]","[{'cui': 'C4055417', 'cui_str': 'avelumab'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.367026,Median duration of response (investigator assessed) was 19.1 months (95% CI: 10.8-34.8) vs 5.7 months (95% CI: 4.1-8.3).,"[{'ForeName': 'Keunchil', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': 'Department of Internal Medicine, Division of Medical Oncology, Cerrahpaşa Medical Faculty, Istanbul University- Cerrahpaşa, Istanbul, Turkey.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Vansteenkiste', 'Affiliation': 'Department of Respiratory Oncology, University Hospital KU Leuven, Leuven, Belgium.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Spigel', 'Affiliation': 'Sarah Cannon Research Institute, Nashville, Tennessee.'}, {'ForeName': 'James C-H', 'Initials': 'JC', 'LastName': 'Yang', 'Affiliation': 'Department of Medical Oncology, National Taiwan University Cancer Center, Taipei, Taiwan.'}, {'ForeName': 'Hidenobu', 'Initials': 'H', 'LastName': 'Ishii', 'Affiliation': 'Department of Internal Medicine, Kurume University School of Medicine, Kurume, Japan.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Garassino', 'Affiliation': 'Thoracic Oncology Unit, Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'de Marinis', 'Affiliation': 'Thoracic Oncology Division, European Institute of Oncology, IRCCS, Milan, Italy.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Szczesna', 'Affiliation': 'Department of Lung Diseases, Regional Lung Disease Hospital, Otwock, Poland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Polychronis', 'Affiliation': 'Department of Medical Oncology, Mount Vernon Cancer Centre, Northwood, Middlesex, United Kingdom.'}, {'ForeName': 'Ruchan', 'Initials': 'R', 'LastName': 'Uslu', 'Affiliation': 'Department of Medical Oncology, Ege University Hospital, Izmir, Turkey.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Krzakowski', 'Affiliation': 'Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie w Warszawie, Warsaw, Poland.'}, {'ForeName': 'Jong-Seok', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea.'}, {'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Calabrò', 'Affiliation': 'Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital of Siena, Siena, Italy.'}, {'ForeName': 'Osvaldo Arén', 'Initials': 'OA', 'LastName': 'Frontera', 'Affiliation': 'Instituto Nacional del Cáncer, Santiago, Chile.'}, {'ForeName': 'Huiling', 'Initials': 'H', 'LastName': 'Xiong', 'Affiliation': 'EMD Serono Research & Development Institute, Inc., Billerica, MA, USA; an affiliate of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Marcis', 'Initials': 'M', 'LastName': 'Bajars', 'Affiliation': 'EMD Serono Research & Development Institute, Inc., Billerica, MA, USA; an affiliate of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Ruisi', 'Affiliation': 'EMD Serono Research & Development Institute, Inc., Billerica, MA, USA; an affiliate of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Barlesi', 'Affiliation': 'Aix Marseille University, CNRS, INSERM, CRCM, Marseille, France†; Gustave Roussy Cancer Campus, Villejuif, France. Electronic address: Fabrice.BARLESI@gustaveroussy.fr.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2021.03.009'] 4091,33845182,"A commentary on ""Coffee consumption for recovery of intestinal function after laparoscopic gynecological surgery: A randomized controlled trial"".",,2021,,['after laparoscopic gynecological surgery'],['Coffee consumption'],['intestinal function'],"[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}]","[{'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.654156,,"[{'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Dongmei Chen', 'Affiliation': 'Department of Gynaecology, Nantong Hospital of Traditional Chinese Medicine, Nantong, Jiangsu, 226000, China.'}, {'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Hongyun Fan', 'Affiliation': ""Department of Pathology, Xuyi People's Hospital, Huaian, Jiangsu, 211700, China. Electronic address: nueborn@163.com.""}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2021.105937'] 4092,33845173,Modulating Brain Rhythms of Pain using Transcranial Alternating Current Stimulation (tACS) - A Sham-controlled Study in Healthy Human Participants.,"Chronic pain is a major health care problem. A better mechanistic understanding and new treatment approaches are urgently needed. In the brain, pain has been associated with neural oscillations at alpha and gamma frequencies, which can be targeted using transcranial alternating current stimulation (tACS). Thus, we investigated the potential of tACS to modulate pain and pain-related autonomic activity in an experimental model of chronic pain in 29 healthy participants. In 6 recording sessions, participants completed a tonic heat pain paradigm and simultaneously received tACS over prefrontal or somatosensory cortices at alpha or gamma frequencies or sham tACS. Concurrently, pain ratings and autonomic responses were collected. Using the present setup, tACS did not modulate pain or autonomic responses. Bayesian statistics confirmed a lack of tACS effects in most conditions. The only exception was alpha tACS over somatosensory cortex where evidence was inconclusive. Taken together, we did not find significant tACS effects on tonic experimental pain in healthy humans. Based on our and previous findings, further studies might apply refined stimulation protocols targeting somatosensory alpha oscillations. TRIAL REGISTRATION: The study protocol was pre-registered at ClinicalTrials.gov (NCT03805854). PERSPECTIVE: Modulating brain oscillations is a promising approach for the treatment of pain. We therefore applied transcranial alternating current stimulation to modulate experimental pain in healthy participants. However, tACS did not modulate pain, autonomic responses or EEG oscillations. These findings help to shape future tACS studies for the treatment of pain.",2021,"However, tACS did not modulate pain, autonomic responses or EEG oscillations.","['Healthy Human Participants', 'healthy participants', '29 healthy participants', 'healthy humans']","['Transcranial Alternating Current Stimulation (tACS) - A Sham-controlled', 'transcranial alternating current stimulation', 'tACS', 'tonic heat pain paradigm and simultaneously received tACS over prefrontal or somatosensory cortices at alpha or gamma frequencies or sham tACS']","['tonic experimental pain', 'pain or autonomic responses', 'Chronic pain', 'pain ratings and autonomic responses', 'pain, autonomic responses or EEG oscillations', 'pain and pain-related autonomic activity']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3543842', 'cui_str': 'TONICS'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0037658', 'cui_str': 'Somatosensory Cortex'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]","[{'cui': 'C3543842', 'cui_str': 'TONICS'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",29.0,0.0921532,"However, tACS did not modulate pain, autonomic responses or EEG oscillations.","[{'ForeName': 'Elisabeth S', 'Initials': 'ES', 'LastName': 'May', 'Affiliation': 'Department of Neurology, School of Medicine, Technical University of Munich (TUM), Munich, Germany; TUM-Neuroimaging Center, School of Medicine, TUM, Munich, Germany.'}, {'ForeName': 'Vanessa D', 'Initials': 'VD', 'LastName': 'Hohn', 'Affiliation': 'Department of Neurology, School of Medicine, Technical University of Munich (TUM), Munich, Germany; TUM-Neuroimaging Center, School of Medicine, TUM, Munich, Germany.'}, {'ForeName': 'Moritz M', 'Initials': 'MM', 'LastName': 'Nickel', 'Affiliation': 'Department of Neurology, School of Medicine, Technical University of Munich (TUM), Munich, Germany; TUM-Neuroimaging Center, School of Medicine, TUM, Munich, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Tiemann', 'Affiliation': 'Department of Neurology, School of Medicine, Technical University of Munich (TUM), Munich, Germany; TUM-Neuroimaging Center, School of Medicine, TUM, Munich, Germany.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Gil Ávila', 'Affiliation': 'Department of Neurology, School of Medicine, Technical University of Munich (TUM), Munich, Germany; TUM-Neuroimaging Center, School of Medicine, TUM, Munich, Germany.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Heitmann', 'Affiliation': 'Department of Neurology, School of Medicine, Technical University of Munich (TUM), Munich, Germany; TUM-Neuroimaging Center, School of Medicine, TUM, Munich, Germany; Center for Interdisciplinary Pain Medicine, School of Medicine, TUM, Munich, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sauseng', 'Affiliation': 'Department of Psychology, Ludwig-Maximilians-Universität München, Munich, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Ploner', 'Affiliation': 'Department of Neurology, School of Medicine, Technical University of Munich (TUM), Munich, Germany; TUM-Neuroimaging Center, School of Medicine, TUM, Munich, Germany; Center for Interdisciplinary Pain Medicine, School of Medicine, TUM, Munich, Germany. Electronic address: markus.ploner@tum.de.'}]",The journal of pain,['10.1016/j.jpain.2021.03.150'] 4093,33845158,Left Ventricular Global Longitudinal Strain as a Predictor of Outcomes in Heart Failure Patients with Secondary Mitral Regurgitation: The COAPT Trial.,"BACKGROUND Left ventricular (LV) global longitudinal strain (GLS) is a sensitive marker of LV function and may help identify patients with heart failure (HF) and secondary mitral regurgitation (SMR) who would have a better prognosis and are more likely to benefit from edge-to-edge transcatheter mitral valve repair (TMVr) with the MitraClip. We sought to assess the prognostic utility of baseline LVGLS during 2-year follow-up of HF patients with SMR enrolled in the COAPT trial. METHODS Symptomatic HF patients with moderate-to-severe or severe SMR who remained symptomatic despite maximally-tolerated guideline directed medical therapy (GDMT) were randomized to TMVr plus GDMT or GDMT alone. Speckle tracking-derived LVGLS from baseline echocardiograms was obtained in 565 patients and categorized by tertiles. Death and HF hospitalization (HFH) at 2-year follow-up were the principal outcomes of interest. RESULTS Patients with better baseline LVGLS had higher blood pressure, greater LV ejection fraction and stroke volume, lower levels of B-type natriuretic peptide and smaller LV size. No significant difference in outcomes at 2-year follow-up were noted according to LVGLS. However, the rate of death or HFH between 10 and 24 months was lower in patients with better LVGLS (p=0.03), with no differences before 10 months. There was no interaction between GLS tertiles and treatment group with respect to 2-year clinical outcomes. CONCLUSIONS Baseline LVGLS did not predict death or HFH throughout 2-year follow-up, but it did predict outcomes after 10 months. The benefit of TMVr over GDMT alone was consistent in all sub-groups irrespective of baseline LVGLS.",2021,"RESULTS Patients with better baseline LVGLS had higher blood pressure, greater LV ejection fraction and stroke volume, lower levels of B-type natriuretic peptide and smaller LV size.","['565 patients and categorized by tertiles', 'HF patients with SMR enrolled in the COAPT trial', 'patients with heart failure (HF) and secondary mitral regurgitation (SMR', 'Heart Failure Patients with Secondary Mitral Regurgitation', 'Symptomatic HF patients with moderate-to-severe or severe SMR who remained symptomatic despite maximally-tolerated guideline directed medical therapy (GDMT']","['TMVr over GDMT', 'Speckle tracking-derived LVGLS', 'TMVr plus GDMT or GDMT alone', 'baseline LVGLS', 'Left ventricular (LV) global longitudinal strain (GLS']","['death or HFH', 'Death and HF hospitalization (HFH', 'rate of death or HFH', 'blood pressure, greater LV ejection fraction and stroke volume, lower levels of B-type natriuretic peptide and smaller LV size']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}]","[{'cui': 'C2921039', 'cui_str': 'Transcatheter mitral valve repair'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0439691', 'cui_str': 'Speckled'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",565.0,0.355314,"RESULTS Patients with better baseline LVGLS had higher blood pressure, greater LV ejection fraction and stroke volume, lower levels of B-type natriuretic peptide and smaller LV size.","[{'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Medvedofsky', 'Affiliation': 'Medstar Health Research Institute, Washington, DC.'}, {'ForeName': 'Stephan Milhorini', 'Initials': 'SM', 'LastName': 'Pio', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Weissman', 'Affiliation': 'Medstar Health Research Institute, Washington, DC; Georgetown University, Washington, DC.'}, {'ForeName': 'Farnaz', 'Initials': 'F', 'LastName': 'Namazi', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Delgado', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Grayburn', 'Affiliation': 'Baylor University Medical Center, Baylor Heart and Vascular Institute, Dallas, TX.'}, {'ForeName': 'Saibal', 'Initials': 'S', 'LastName': 'Kar', 'Affiliation': 'Los Robles Regional Medical Center, Thousand Oaks, CA; Bakersfield Heart Hospital, Bakersfield, CA.'}, {'ForeName': 'D Scott', 'Initials': 'DS', 'LastName': 'Lim', 'Affiliation': 'Division of Cardiology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Stamatios', 'Initials': 'S', 'LastName': 'Lerakis', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Zhipeng', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, NY.'}, {'ForeName': 'Mengdan', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, NY.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Alu', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, NY.'}, {'ForeName': 'Samir R', 'Initials': 'SR', 'LastName': 'Kapadia', 'Affiliation': 'Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'JoAnn', 'Initials': 'J', 'LastName': 'Lindenfeld', 'Affiliation': 'Advanced Heart Failure and Cardiac Transplantation Section, Vanderbilt Heart and Vascular Institute, Nashville, TN.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Abraham', 'Affiliation': 'Division of Cardiovascular Medicine, The Ohio State University Medical Center, Columbus, OH.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Mack', 'Affiliation': 'Baylor Scott & White Health, Plano, TX.'}, {'ForeName': 'Jeroen J', 'Initials': 'JJ', 'LastName': 'Bax', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY; Clinical Trials Center, Cardiovascular Research Foundation, New York, NY.'}, {'ForeName': 'Federico M', 'Initials': 'FM', 'LastName': 'Asch', 'Affiliation': 'Medstar Health Research Institute, Washington, DC; Georgetown University, Washington, DC. Electronic address: federico.asch@medstar.net.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography,['10.1016/j.echo.2021.04.003'] 4094,33845098,"Effect of preoperative oral liquid carbohydrate intake on blood glucose, fasting-thirst, and fatigue levels: a randomized controlled study.","BACKGROUND This study aimed to analyze the effects of preoperative oral intake of liquid carbohydrate on postoperative blood glucose, fasting-thirst, and fatigue levels in patients undergoing arthroscopic surgery. METHODS This randomized controlled clinical trial enrolled 82 patients, who were scheduled to undergo arthroscopic surgery, and divided them into two groups: (1) those who consumed a carbohydrate-rich drink and (2) those not consuming anything after midnight. Pre- and postoperative fasting-thirst (visual analog scale) and blood glucose levels were measured. Likewise, the Brief Fatigue Inventory was applied to patients 24 hours after surgery. RESULTS The mean blood glucose levels in the first postoperative hour were 90.90 ± 13.56 mg.dL -1 and 107.00 ± 15.84 mg.dL -1 in the intervention group and control group, respectively (p <  0.001). The postoperative mean thirst scores were 4.70 ± 1.59 and 6.36 ± 2.07 in the intervention group and control group, respectively (p <  0.001). Their corresponding postoperative mean fasting scores were 5.54 ± 1.76 and 5.86 ± 1.79 (p >  0.05) and the mean fatigue levels in the 24 th postoperative hour were 4.80 ± 2.13 and 5.48 ± 1.46, respectively (p >  0.05). CONCLUSIONS Oral intake of liquid carbohydrate before spinal anesthesia was found to have positive effects on patients' postoperative blood glucose and thirst levels.",2021,"The mean blood glucose levels in the first postoperative hour were 90.90 ± 13.56 mg.dL -1 and 107.00 ± 15.84 mg.dL -1 in the intervention group and control group, respectively (p <  0.001).","['82 patients, who were scheduled to undergo', 'patients undergoing arthroscopic surgery']","['arthroscopic surgery', 'carbohydrate-rich drink and (2) those not consuming anything after midnight', 'liquid carbohydrate', 'preoperative oral liquid carbohydrate intake']","['Pre- and postoperative fasting-thirst (visual analog scale) and blood glucose levels', 'mean blood glucose levels', 'postoperative mean fasting scores', 'postoperative mean thirst scores', 'mean fatigue levels', 'postoperative blood glucose, fasting-thirst, and fatigue levels', 'blood glucose, fasting-thirst, and fatigue levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0750934', 'cui_str': 'Arthroscopy with surgical procedure'}]","[{'cui': 'C0750934', 'cui_str': 'Arthroscopy with surgical procedure'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0332172', 'cui_str': 'Midnight'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C1273619', 'cui_str': 'Oral Liquid Product'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2586108', 'cui_str': 'Level of fatigue'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}]",82.0,0.0608583,"The mean blood glucose levels in the first postoperative hour were 90.90 ± 13.56 mg.dL -1 and 107.00 ± 15.84 mg.dL -1 in the intervention group and control group, respectively (p <  0.001).","[{'ForeName': 'Gökçen Aydın', 'Initials': 'GA', 'LastName': 'Akbuğa', 'Affiliation': 'Bozok University, Faculty of Health Sciences/Surgery Nursing, Yozgat, Turkey. Electronic address: gokcen86@windowslive.com.'}, {'ForeName': 'Mürüvvet', 'Initials': 'M', 'LastName': 'Başer', 'Affiliation': ""Erciyes University, Faculty of Health Sciences/Women's Health and Childbirth Nursing, Kayseri, Turkey.""}]",Brazilian journal of anesthesiology (Elsevier),['10.1016/j.bjane.2021.02.053'] 4095,33862286,"Effectiveness of an intensive, functional, gamified rehabilitation program in improving upper limb motor function in people with stroke: A protocol of the EnteRtain randomized clinical trial.","INTRODUCTION Game-based rehabilitation is an emerging therapeutic intervention that allows intensive, repetitive, task-based training to improve upper limb (UL) function following stroke, based on the principles of neuro-plasticity and motor (re)learning. Rehabilitation using commercial gaming system will be motivating, enjoyable, challenging and affordable. Therefore, the present study aims at assessing the effectiveness of an intensive, functional, gamified rehabilitation program using the ArmAble™ device in improving UL motor function in people with stroke. METHOD In this single-blinded, multi-centric, randomized clinical trial, 120 adults with acute/sub-acute unilateral stroke will be randomized to receive an intensive, functional, gamified training program using the ArmAble™ or task-based training along with a conventional therapy for 2 h/day, 6 days/week for 2 weeks, followed by a home-based, functional rehabilitation program for another 4 weeks (~30 min/day, 6 days/week). Primary outcomes evaluated by a blinded assessor at the baseline, 2 weeks and 6 weeks' post-intervention will include Fugl-Meyer assessment - upper extremity and Action research arm test. A linear mixed effect regression model or relevant non-parametric tests will be used to analyze the data for all outcomes. An intention-to-treat analysis will be used with missing data handled by multiple imputation. DISCUSSION Rehabilitation provided with the ArmAble™ device, if found effective, can be used from the early stages post-stroke to provide intensive, repetitive, gamified training to improve UL motor function. TRIAL REGISTRATION NUMBER CTRI/2020/09/027651.",2021,"DISCUSSION Rehabilitation provided with the ArmAble™ device, if found effective, can be used from the early stages post-stroke to provide intensive, repetitive, gamified training to improve UL motor function. ","['120 adults with acute/sub-acute unilateral stroke', 'people with stroke']","['intensive, functional, gamified rehabilitation program', 'intensive, functional, gamified training program using the ArmAble™ or task-based training along with a conventional therapy']",['Fugl-Meyer assessment - upper extremity and Action research arm test'],"[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C4720875', 'cui_str': 'Action research arm test'}]",120.0,0.0164573,"DISCUSSION Rehabilitation provided with the ArmAble™ device, if found effective, can be used from the early stages post-stroke to provide intensive, repetitive, gamified training to improve UL motor function. ","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sulfikar Ali', 'Affiliation': 'Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal 576104, Karnataka, India. Electronic address: sulfikar.ali@learner.manipal.edu.'}, {'ForeName': 'Ashokan', 'Initials': 'A', 'LastName': 'Arumugam', 'Affiliation': 'Department of Physiotherapy, College of Health Sciences, University of Sharjah, P.O. Box.27272, Sharjah, United Arab Emirates; Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal 576104, Karnataka, India. Electronic address: aarumugam@sharjah.ac.ae.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Senthil Kumaran', 'Affiliation': 'Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal 576104, Karnataka, India. Electronic address: senthil.kumaran@manipal.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106381'] 4096,33862126,"Insulin fast-dissolving film for intranasal delivery via olfactory region, a promising approach for the treatment of anosmia in COVID-19 patients: Design, in-vitro characterization and clinical evaluation.","The present work aimed to formulate intranasal insulin fast-dissolving films for treatment of anosmia in patients post COVID-19 infection. Variant films were prepared employing the casting method and using hydroxypropyl methyl cellulose and polyvinyl alcohol. The formulated films were investigated for insulin content, weight variation, surface pH, thickness, folding endurance and disintegration time. In vitro release study was conducted for the selected formulations (F6, F7, F8). A drug/polymer interaction was investigated in the optimized formulation (F7) employing Fourier transform infrared spectroscopy. Clinical study was accomplished for F7 on 20 patients. Sniffin's and olfactory discrimination tests were used for assessing patients. The formulated films displayed appropriate physical characteristics. F7 showed the shortest disintegration time (50±7 seconds) and fastest release. It displayed compatibility between the drug and the used polymers. The results of the clinical study revealed a significant increase in the olfactory detection scores and olfactory discrimination values in the intervention group (7.9±1.2, 6.7±0.5 respectively) compared to placebo group (3±0.8, 2.8±1).. Intervention group showed significant differences between these scores before and after treatment while the placebo group did not display any significant differences. Thus, the optimized film can be considered as an auspicious approach for managing post COVID-19 anosmia.",2021,"The results of the clinical study revealed a significant increase in the olfactory detection scores and olfactory discrimination values in the intervention group (7.9±1.2, 6.7±0.5 respectively) compared to placebo group (3±0.8, 2.8±1)..","['20 patients', 'anosmia in COVID-19 patients', 'patients post COVID-19 infection']","['intranasal insulin fast-dissolving films', 'placebo', 'hydroxypropyl methyl cellulose and polyvinyl alcohol']","['insulin content, weight variation, surface pH, thickness, folding endurance and disintegration time', 'olfactory detection scores and olfactory discrimination values', 'shortest disintegration time (50±7 seconds) and fastest release']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003126', 'cui_str': 'Loss of sense of smell'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C1549535', 'cui_str': 'Dissolve'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0063242', 'cui_str': 'hypromellose'}, {'cui': 'C0025729', 'cui_str': 'Methylcellulose'}, {'cui': 'C0032623', 'cui_str': 'Polyvinyl Alcohol'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C1265875', 'cui_str': 'Disintegration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]",20.0,0.0262867,"The results of the clinical study revealed a significant increase in the olfactory detection scores and olfactory discrimination values in the intervention group (7.9±1.2, 6.7±0.5 respectively) compared to placebo group (3±0.8, 2.8±1)..","[{'ForeName': 'Soad A', 'Initials': 'SA', 'LastName': 'Mohamad', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Deraya University, Minia, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Badawi', 'Affiliation': 'Department of otorhinolaryngology, Faculty of Medicine, Minia University, Minia, Egypt.'}, {'ForeName': 'Heba F', 'Initials': 'HF', 'LastName': 'Mansour', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Minia University, Minia, Egypt. Electronic address: heba_mansour@mu.edu.eg.'}]",International journal of pharmaceutics,['10.1016/j.ijpharm.2021.120600'] 4097,33862001,"Patient-centred outcomes and effect of disease progression on health status in patients with newly diagnosed advanced ovarian cancer and a BRCA mutation receiving maintenance olaparib or placebo (SOLO1): a randomised, phase 3 trial.","BACKGROUND In the phase 3 SOLO1 trial, maintenance olaparib provided a significant progression-free survival benefit versus placebo in patients with newly diagnosed, advanced ovarian cancer and a BRCA mutation in response after platinum-based chemotherapy. We analysed health-related quality of life (HRQOL) and patient-centred outcomes in SOLO1, and the effect of radiological disease progression on health status. METHODS SOLO1 is a randomised, double-blind, international trial done in 118 centres and 15 countries. Eligible patients were aged 18 years or older; had an Eastern Cooperative Oncology Group performance status score of 0-1; had newly diagnosed, advanced, high-grade serous or endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer with a BRCA mutation; and were in clinical complete or partial response to platinum-based chemotherapy. Patients were randomly assigned (2:1) to either 300 mg olaparib tablets or placebo twice per day using an interactive voice and web response system and were treated for up to 2 years. Treatment assignment was masked for patients and for clinicians giving the interventions, and those collecting and analysing the data. Randomisation was stratified by response to platinum-based chemotherapy (clinical complete or partial response). HRQOL was a secondary endpoint and the prespecified primary HRQOL endpoint was the change from baseline in the Functional Assessment of Cancer Therapy-Ovarian Cancer Trial Outcome Index (TOI) score for the first 24 months. TOI scores range from 0 to 100 (higher scores indicated better HRQOL), with a clinically meaningful difference defined as a difference of at least 10 points. Prespecified exploratory endpoints were quality-adjusted progression-free survival and time without significant symptoms of toxicity (TWiST). HRQOL endpoints were analysed in all randomly assigned patients. The trial is ongoing but closed to new participants. This trial is registered with ClinicalTrials.gov, NCT01844986. FINDINGS Between Sept 3, 2013, and March 6, 2015, 1084 patients were enrolled. 693 patients were ineligible, leaving 391 eligible patients who were randomly assigned to olaparib (n=260) or placebo (n=131; one placebo patient withdrew before receiving any study treatment), with a median duration of follow-up of 40·7 months (IQR 34·9-42·9) for olaparib and 41·2 months (32·2-41·6) for placebo. There was no clinically meaningful change in TOI score at 24 months within or between the olaparib and placebo groups (adjusted mean change in score from baseline over 24 months was 0·30 points [95% CI -0·72 to 1·32] in the olaparib group vs 3·30 points [1·84 to 4·76] in the placebo group; between-group difference of -3·00, 95% CI -4·78 to -1·22; p=0·0010). Mean quality-adjusted progression-free survival (olaparib 29·75 months [95% CI 28·20-31·63] vs placebo 17·58 [15·05-20·18]; difference 12·17 months [95% CI 9·07-15·11], p<0·0001) and the mean duration of TWiST (olaparib 33·15 months [95% CI 30·82-35·49] vs placebo 20·24 months [17·36-23·11]; difference 12·92 months [95% CI 9·30-16·54]; p<0·0001) were significantly longer with olaparib than with placebo. INTERPRETATION The substantial progression-free survival benefit provided by maintenance olaparib in the newly diagnosed setting was achieved with no detrimental effect on patients' HRQOL and was supported by clinically meaningful quality-adjusted progression-free survival and TWiST benefits with maintenance olaparib versus placebo. FUNDING AstraZeneca and Merck Sharp & Dohme.",2021,"There was no clinically meaningful change in TOI score at 24 months within or between the olaparib and placebo groups (adjusted mean change in score from baseline over 24 months was 0·30 points [95% CI -0·72 to 1·32] in the olaparib group vs 3·30 points [1·84 to 4·76] in the placebo group; between-group difference of -3·00, 95% CI -4·78 to -1·22; p=0·0010).","['Eligible patients were aged 18 years or older; had an Eastern Cooperative Oncology Group performance status score of 0-1; had newly diagnosed, advanced, high-grade serous or endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer with a BRCA mutation; and were in clinical complete or partial response to platinum-based chemotherapy', 'patients with newly diagnosed advanced ovarian cancer and a BRCA mutation receiving maintenance olaparib or', '1084 patients were enrolled', '693 patients were ineligible, leaving 391 eligible patients', 'patients with newly diagnosed, advanced ovarian cancer and a BRCA mutation in response after platinum-based chemotherapy', '118 centres and 15 countries', 'Between Sept 3, 2013, and March 6, 2015']","['placebo (SOLO1', 'olaparib', 'olaparib tablets or placebo', 'placebo', 'platinum-based chemotherapy', 'placebo 17·58']","['TOI) score', 'health-related quality of life (HRQOL', 'mean duration of TWiST', 'quality-adjusted progression-free survival and time without significant symptoms of toxicity (TWiST', 'Functional Assessment of Cancer Therapy-Ovarian Cancer Trial Outcome Index', 'Mean quality-adjusted progression-free survival', 'TOI scores range', 'health status', 'TOI score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0440743', 'cui_str': 'Serous'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0153467', 'cui_str': 'Malignant tumor of peritoneum'}, {'cui': 'C0153579', 'cui_str': 'Malignant tumor of fallopian tube'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C4520027', 'cui_str': 'olaparib Oral Tablet'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0018759', 'cui_str': 'Health status'}]",693.0,0.906717,"There was no clinically meaningful change in TOI score at 24 months within or between the olaparib and placebo groups (adjusted mean change in score from baseline over 24 months was 0·30 points [95% CI -0·72 to 1·32] in the olaparib group vs 3·30 points [1·84 to 4·76] in the placebo group; between-group difference of -3·00, 95% CI -4·78 to -1·22; p=0·0010).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Friedlander', 'Affiliation': 'University of New South Wales Clinical School, Prince of Wales Hospital, Randwick, NSW, Australia. Electronic address: m.friedlander@unsw.edu.au.'}, {'ForeName': 'Kathleen N', 'Initials': 'KN', 'LastName': 'Moore', 'Affiliation': 'Stephenson Cancer Center, University of Oklahoma, Oklahoma City, OK, USA.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': 'University of Milan-Bicocca, Milan, Italy; Istituto Europeo di Oncologia IRCCS, Milan, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': 'Fondazione Policlinico Universitario A Gemelli IRCCS, Università Cattolica, Rome, Italy.'}, {'ForeName': 'Byoung-Gie', 'Initials': 'BG', 'LastName': 'Kim', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Oaknin', 'Affiliation': ""Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.""}, {'ForeName': 'Alla', 'Initials': 'A', 'LastName': 'Lisyanskaya', 'Affiliation': 'St Petersburg City Oncology Dispensary, St Petersburg, Russia.'}, {'ForeName': 'Gabe S', 'Initials': 'GS', 'LastName': 'Sonke', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Gourley', 'Affiliation': 'Cancer Research UK Edinburgh Centre, Institute of Genetics and Molecular Medicine, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, UK; Institute of Cancer Research, London, UK.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Oza', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'González-Martín', 'Affiliation': 'Clínica Universidad de Navarra, Madrid, Spain.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Aghajanian', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Bradley', 'Affiliation': 'Froedtert and the Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Mathews', 'Affiliation': 'Women and Infants Hospital, Providence, RI, USA.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Selle', 'Affiliation': ""Groupe Hospitalier Diaconesses Croix Saint-Simon, Paris, France; Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO), Paris, France.""}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Lortholary', 'Affiliation': ""Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO), Paris, France; Centre Catherine de Sienne Hopital privé du Confluent, Nantes, France.""}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Lowe', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hettle', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Emuella', 'Initials': 'E', 'LastName': 'Flood', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Parkhomenko', 'Affiliation': 'PAREXEL, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'DiSilvestro', 'Affiliation': 'Women and Infants Hospital, Providence, RI, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(21)00098-X'] 4098,33862000,"Neoadjuvant chemotherapy with FOLFIRINOX and preoperative chemoradiotherapy for patients with locally advanced rectal cancer (UNICANCER-PRODIGE 23): a multicentre, randomised, open-label, phase 3 trial.","BACKGROUND Treatment of locally advanced rectal cancer with chemoradiotherapy, surgery, and adjuvant chemotherapy controls local disease, but distant metastases remain common. We aimed to assess whether administering neoadjuvant chemotherapy before preoperative chemoradiotherapy could reduce the risk of distant recurrences. METHODS We did a phase 3, open-label, multicentre, randomised trial at 35 hospitals in France. Eligible patients were adults aged 18-75 years and had newly diagnosed, biopsy-proven, rectal adenocarcinoma staged cT3 or cT4 M0, with a WHO performance status of 0-1. Patients were randomly assigned (1:1) to either the neoadjuvant chemotherapy group or standard-of-care group, using an independent web-based system by minimisation method stratified by centre, extramural extension of the tumour into perirectal fat according to MRI, tumour location, and stage. Investigators and participants were not masked to treatment allocation. The neoadjuvant chemotherapy group received neoadjuvant chemotherapy with FOLFIRINOX (oxaliplatin 85 mg/m 2 , irinotecan 180 mg/m 2 , leucovorin 400 mg/m 2 , and fluorouracil 2400 mg/m 2 intravenously every 14 days for 6 cycles), chemoradiotherapy (50 Gy during 5 weeks and 800 mg/m 2 concurrent oral capecitabine twice daily for 5 days per week), total mesorectal excision, and adjuvant chemotherapy (3 months of modified FOLFOX6 [intravenous oxaliplatin 85 mg/m 2 and leucovorin 400 mg/m 2 , followed by intravenous 400 mg/m 2 fluorouracil bolus and then continuous infusion at a dose of 2400 mg/m 2 over 46 h every 14 days for six cycles] or capecitabine [1250 mg/m 2 orally twice daily on days 1-14 every 21 days]). The standard-of-care group received chemoradiotherapy, total mesorectal excision, and adjuvant chemotherapy (for 6 months). The primary endpoint was disease-free survival assessed in the intention-to-treat population at 3 years. Safety analyses were done on treated patients. This trial was registered with EudraCT (2011-004406-25) and ClinicalTrials.gov (NCT01804790) and is now complete. FINDINGS Between June 5, 2012, and June 26, 2017, 461 patients were randomly assigned to either the neoadjuvant chemotherapy group (n=231) or the standard-of-care group (n=230). At a median follow-up of 46·5 months (IQR 35·4-61·6), 3-year disease-free survival rates were 76% (95% CI 69-81) in the neoadjuvant chemotherapy group and 69% (62-74) in the standard-of-care group (stratified hazard ratio 0·69, 95% CI 0·49-0·97; p=0·034). During neoadjuvant chemotherapy, the most common grade 3-4 adverse events were neutropenia (38 [17%] of 225 patients) and diarrhoea (25 [11%] of 226). During chemoradiotherapy, the most common grade 3-4 adverse event was lymphopenia (59 [28%] of 212 in the neoadjuvant chemotherapy group vs 67 [30%] of 226 patients in the standard-of-care group). During adjuvant chemotherapy, the most common grade 3-4 adverse events were lymphopenia (18 [11%] of 161 in the neoadjuvant chemotherapy group vs 42 [27%] of 155 in the standard-of-care group), neutropenia (nine [6%] of 161 vs 28 [18%] of 155), and peripheral sensory neuropathy (19 [12%] of 162 vs 32 [21%] of 155). Serious adverse events occurred in 63 (27%) of 231 participants in the neoadjuvant chemotherapy group and 50 (22%) of 230 patients in the standard-of-care group (p=0·167), during the whole treatment period. During adjuvant therapy, serious adverse events occurred in 18 (11%) of 163 participants in the neoadjuvant chemotherapy group and 36 (23%) of 158 patients in the standard-of-care group (p=0·0049). Treatment-related deaths occurred in one (<1%) of 226 patients in the neoadjuvant chemotherapy group (sudden death) and two (1%) of 227 patients in the standard-of-care group (one sudden death and one myocardial infarction). INTERPRETATION Intensification of chemotherapy using FOLFIRINOX before preoperative chemoradiotherapy significantly improved outcomes compared with preoperative chemoradiotherapy in patients with cT3 or cT4 M0 rectal cancer. The significantly improved disease-free survival in the neoadjuvant chemotherapy group and the decreased neurotoxicity indicates that the perioperative approach is more efficient and better tolerated than adjuvant chemotherapy. Therefore, the PRODIGE 23 results might change clinical practice. FUNDING Institut National du Cancer, Ligue Nationale Contre le Cancer, and R&D Unicancer.",2021,"Treatment-related deaths occurred in one (<1%) of 226 patients in the neoadjuvant chemotherapy group (sudden death) and two (1%) of 227 patients in the standard-of-care group (one sudden death and one myocardial infarction). ","['35 hospitals in France', 'patients with locally advanced rectal cancer (UNICANCER-PRODIGE 23', 'Between June 5, 2012, and June 26, 2017, 461 patients', 'patients with cT3 or cT4 M0 rectal cancer', 'Eligible patients were adults aged 18-75 years and had newly diagnosed, biopsy-proven, rectal adenocarcinoma staged cT3 or cT4 M0, with a WHO performance status of 0-1']","['oxaliplatin 85 mg/m 2 and leucovorin', 'neoadjuvant chemotherapy with FOLFIRINOX (oxaliplatin 85 mg/m 2 , irinotecan 180 mg/m 2 , leucovorin 400 mg/m 2 , and fluorouracil', 'Neoadjuvant chemotherapy with FOLFIRINOX and preoperative chemoradiotherapy', 'capecitabine', 'neoadjuvant chemotherapy before preoperative chemoradiotherapy', 'EudraCT', 'total mesorectal excision, and adjuvant chemotherapy (3 months of modified FOLFOX6', 'preoperative chemoradiotherapy', 'chemoradiotherapy, total mesorectal excision, and adjuvant chemotherapy', 'neoadjuvant chemotherapy group or standard-of-care group, using an independent web-based system', 'neoadjuvant chemotherapy', 'chemoradiotherapy (50 Gy during 5 weeks and 800 mg/m 2 concurrent oral capecitabine']","['peripheral sensory neuropathy', 'Serious adverse events', 'sudden death and one myocardial infarction', 'disease-free survival', 'deaths', 'neutropenia', 'serious adverse events', 'diarrhoea', 'risk of distant recurrences', 'lymphopenia', '3-year disease-free survival rates']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C1175872', 'cui_str': 'CAGE1 protein, human'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0149978', 'cui_str': 'Adenocarcinoma of rectum'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4742253', 'cui_str': 'folfirinox'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0151313', 'cui_str': 'Sensory neuropathy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011071', 'cui_str': 'Sudden death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0439234', 'cui_str': 'year'}]",461.0,0.212315,"Treatment-related deaths occurred in one (<1%) of 226 patients in the neoadjuvant chemotherapy group (sudden death) and two (1%) of 227 patients in the standard-of-care group (one sudden death and one myocardial infarction). ","[{'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Conroy', 'Affiliation': 'Institut de Cancérologie de Lorraine, Université de Lorraine, Nancy, France; APEMAC, Université de Lorraine, Nancy, France. Electronic address: t.conroy@nancy.unicancer.fr.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Bosset', 'Affiliation': 'Hôpital Nord Franche-Comté, Montbéliard, France; University Hospital of Besançon, Besançon, France.'}, {'ForeName': 'Pierre-Luc', 'Initials': 'PL', 'LastName': 'Etienne', 'Affiliation': ""CARIO, Hôpital privé des côtes d'Armor, Plérin, France.""}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Rio', 'Affiliation': ""Institut de Cancérologie de l'Ouest-Site René Gauducheau, Saint-Herblain, France.""}, {'ForeName': 'Éric', 'Initials': 'É', 'LastName': 'François', 'Affiliation': 'Centre Antoine Lacassagne, Nice, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Mesgouez-Nebout', 'Affiliation': ""Institut de Cancérologie de l'Ouest-Site Paul Papin, Angers, France.""}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Vendrely', 'Affiliation': 'Centre Hospitalier et Universitaire de Bordeaux, Hôpital Haut-Lévêque, Pessac, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Artignan', 'Affiliation': 'Centre Hospitalier Privé Saint-Grégoire, Saint-Grégoire, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bouché', 'Affiliation': 'Hôpital Robert Debré, Reims, France.'}, {'ForeName': 'Dany', 'Initials': 'D', 'LastName': 'Gargot', 'Affiliation': 'Centre Hospitalier de Blois, Blois, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Boige', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Bonichon-Lamichhane', 'Affiliation': 'Clinique Tivoli, Bordeaux, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Louvet', 'Affiliation': 'Institut Mutualiste Montsouris, Paris, France.'}, {'ForeName': 'Clotilde', 'Initials': 'C', 'LastName': 'Morand', 'Affiliation': 'Centre Hospitalier Départemental, Site de la Roche-sur-Yon, La Roche-sur-Yon, France.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'de la Fouchardière', 'Affiliation': 'Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Najib', 'Initials': 'N', 'LastName': 'Lamfichekh', 'Affiliation': 'Hôpital Nord Franche-Comté, Montbéliard, France.'}, {'ForeName': 'Béata', 'Initials': 'B', 'LastName': 'Juzyna', 'Affiliation': 'R&D UNICANCER, Paris, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Jouffroy-Zeller', 'Affiliation': 'R&D UNICANCER, Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Rullier', 'Affiliation': 'Centre Hospitalier et Universitaire de Bordeaux, Hôpital Haut-Lévêque, Pessac, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Marchal', 'Affiliation': 'Institut de Cancérologie de Lorraine, Université de Lorraine, Nancy, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Gourgou', 'Affiliation': 'Institut Régional du Cancer de Montpellier, Université de Montpellier, Montpellier, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Castan', 'Affiliation': 'Institut Régional du Cancer de Montpellier, Université de Montpellier, Montpellier, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Borg', 'Affiliation': 'Hôpital Nord Franche-Comté, Montbéliard, France; University Hospital of Besançon, Besançon, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(21)00079-6'] 4099,33861979,Does Public Reporting of Staffing Ratios and Nursing Home Compare Ratings Matter?,"OBJECTIVE Public reporting is a policy to improve quality and increase data transparency. The objective was to examine the association between publicly available staffing ratios and the Five-Star Quality Ratings from Nursing Home Compare over time. DESIGN Panel data analysis. SETTING and Participants: 146 nursing homes with complete quarterly data in New Jersey between January 1, 2012, and December 31, 2019. METHODS Using data from the State of New Jersey Department of Health and Nursing Home Compare, staff-to-resident ratios were trended for registered nurses, licensed practical nurses, and certified nursing assistants by shift and over time. Panel data analysis was used to test the association between the ratios and the ratings. RESULTS Compared to 2012, staffing ratios improved slightly for licensed practical nurses but not for registered nurses or certified nursing assistants in 2019 (P < .001). The number of residents assigned doubled at night for all personnel. During the day and evening shifts, registered nurse staffing was significantly associated with the Nursing Home Compare staffing rating (P < .01) but not the overall rating. CONCLUSIONS AND IMPLICATIONS Decreasing the number of residents assigned to a registered nurse in NHs results in an increase in staffing ratings. Mandatory public reporting holds nursing homes accountable for quality outcomes but does not improve staffing ratios. Quality resident care is the cumulative result of multiple measures inclusive of staffing; therefore, administrators should continue to focus on improving quality in NHs, which may improve staffing ratios across shifts.",2021,"Compared to 2012, staffing ratios improved slightly for licensed practical nurses but not for registered nurses or certified nursing assistants in 2019 (P < .001).","['Using data from the State of New Jersey Department of Health and Nursing Home Compare, staff-to-resident ratios were trended for registered nurses, licensed practical nurses, and certified nursing assistants by shift and over time', 'and Participants: 146 nursing homes with complete quarterly data in New Jersey between January 1, 2012, and December 31,\xa02019']",[],['staffing ratios improved slightly for licensed practical nurses'],"[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0027971', 'cui_str': 'New Jersey'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040833', 'cui_str': 'trends'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse'}, {'cui': 'C0684004', 'cui_str': 'Licensed practical nurse'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0028663', 'cui_str': 'Nursing aid'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}]",[],"[{'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0750482', 'cui_str': 'Slightly'}, {'cui': 'C0684004', 'cui_str': 'Licensed practical nurse'}]",,0.0791428,"Compared to 2012, staffing ratios improved slightly for licensed practical nurses but not for registered nurses or certified nursing assistants in 2019 (P < .001).","[{'ForeName': 'Pamela B', 'Initials': 'PB', 'LastName': 'de Cordova', 'Affiliation': 'Rutgers, The State University of New Jersey, Newark, NJ, USA; Research Faculty of the New Jersey Collaborating Center for Nursing, Newark, NJ, USA. Electronic address: pd306@sn.rutgers.edu.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Johansen', 'Affiliation': 'Rutgers, The State University of New Jersey, Newark, NJ, USA.'}, {'ForeName': 'Peijia', 'Initials': 'P', 'LastName': 'Zha', 'Affiliation': 'Rutgers, The State University of New Jersey, Newark, NJ, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Prado', 'Affiliation': 'Rutgers, The State University of New Jersey, Newark, NJ, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Field', 'Affiliation': 'New Jersey Collaborating Center for Nursing, Newark, NJ, USA.'}, {'ForeName': 'Edna', 'Initials': 'E', 'LastName': 'Cadmus', 'Affiliation': 'Rutgers, The State University of New Jersey, Newark, NJ, USA; New Jersey Collaborating Center for Nursing, Newark, NJ, USA.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2021.03.011'] 4100,33861881,Health warning labels and alcohol selection: a randomised controlled experiment in a naturalistic shopping laboratory.,"BACKGROUND AND AIMS Health warning labels (HWLs) on tobacco products reduce smoking. There is an absence of evidence concerning the impact of alcohol HWLs on selection or purchasing in naturalistic settings. Using a commercial-standard naturalistic shopping laboratory, this study aimed to estimate the impact on selection of alcoholic drinks of HWLs describing adverse health consequences of excessive alcohol consumption. DESIGN A between-subjects randomised experiment with three groups was conducted: Group 1: image-and-text HWL; Group 2: text-only HWL; Group 3: no HWL. SETTING A commercial-standard naturalistic shopping laboratory in the United Kingdom. PARTICIPANTS Adults (n=399, 55% female) over the age of 18, who purchased beer or wine weekly to drink at home. INTERVENTIONS Participants were randomised to one of three groups varying in the HWL displayed on the packaging of the alcoholic drinks: i. image-and-text HWL (n=135); ii. text-only HWL (n=129); iii. no HWL (n=135). Participants completed a shopping task, selecting items from a range of alcoholic and non-alcoholic drinks, and snacks. MEASUREMENT The primary outcome was the proportion of alcoholic drinks selected. Secondary outcomes included HWL ratings on negative emotional arousal and label acceptability. FINDINGS There was no clear evidence of a difference in the HWL groups for the percentage of drinks selected that were alcoholic compared to no HWL (44%): image-and-text HWL: 46% (OR=1.08, 95%CI=0.82,1.42); text-only HWL: 41% (OR=0.87, 95%CI=0.67,1.14). Concordant with there being no difference between groups, there was extreme evidence in favour of the null hypothesis (Bayes factor [BF] < 0.01). Negative emotional arousal was higher (p< 0.001) and acceptability lower (p< 0.001) in the image-and-text HWL group, compared to the text-only HWL group. CONCLUSIONS In a naturalistic shopping laboratory, there was no evidence that health warning labels describing the adverse health consequences of excessive alcohol consumption changed selection behaviour.",2021,"Negative emotional arousal was higher (p< 0.001) and acceptability lower (p< 0.001) in the image-and-text HWL group, compared to the text-only HWL group. ","['A commercial-standard naturalistic shopping laboratory in the United Kingdom', 'Adults (n=399, 55% female) over the age of 18, who purchased beer or wine weekly to drink at home']","['alcoholic drinks: i. image-and-text HWL', 'image-and-text HWL; Group 2: text-only HWL; Group 3: no HWL', 'Health warning labels and alcohol selection']","['HWL ratings on negative emotional arousal and label acceptability', 'Negative emotional arousal', 'proportion of alcoholic drinks selected']","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0150768', 'cui_str': 'Shopping'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0004922', 'cui_str': 'Beer'}, {'cui': 'C0043188', 'cui_str': 'Wine'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0556305', 'cui_str': 'Drinks at home'}]","[{'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}]",,0.147784,"Negative emotional arousal was higher (p< 0.001) and acceptability lower (p< 0.001) in the image-and-text HWL group, compared to the text-only HWL group. ","[{'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Clarke', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Anna K M', 'Initials': 'AKM', 'LastName': 'Blackwell', 'Affiliation': 'Tobacco and Alcohol Research Group, School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'De-Loyde', 'Affiliation': 'Tobacco and Alcohol Research Group, School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Pechey', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Hobson', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Pilling', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Morris', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol.'}, {'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Marteau', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Gareth J', 'Initials': 'GJ', 'LastName': 'Hollands', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}]","Addiction (Abingdon, England)",['10.1111/add.15519'] 4101,33861813,EmoTIC: Impact of a game-based social-emotional programme on adolescents.,"INTRODUCTION Technologies provide a brilliant opportunity to promote social-emotional competences, well-being and adjustment in adolescence. Game-based programmes and serious games are digital tools that pursue an educational goal in an attractive environment for adolescents. The purpose of this study was therefore to determine the effectiveness of emoTIC, a game-based social-emotional programme designed according to Mayer, Caruso, and Salovey's model of emotional intelligence. MATERIALS AND METHODS The participants were 119 adolescents between 11 and 15 years, randomly assigned to the experimental group and the control group. The adolescents completed questionnaires to assess their emotional intelligence, self-esteem, affect balance, difficulties, prosocial behaviour, depression, anxiety and stress. RESULTS The MANCOVA results showed that adolescents who completed the game-based programme had improved self-esteem, affect balance, emotional symptoms, behavioural problems, and hyperactivity (Wilks' λ = .77; F = 2.10; p = .035). Hierarchical multiple regression indicated that adolescents in the experimental group had a greater change in self-esteem and affect balance (positive β), while their emotional problems and hyperactivity decreased (negative β). Anxiety moderated the influence of the intervention on self-esteem (b = .04; t = -2.55; p ≤ .05; LLCI = -0.43, ULCI = -0.05). Adolescents with low or medium anxiety improved their self-esteem with the intervention, while those with high anxiety did not develop it. CONCLUSIONS The use of technology in social-emotional programmes could be the first step in increasing adolescents' interest in emotions and emoTIC could be considered a useful programme which influences their personal, emotional and social factors. TRIAL REGISTRATION Clinical Trial identifier: NCT04414449.",2021,"Anxiety moderated the influence of the intervention on self-esteem (b = .04; t = -2.55; p ≤ .05; LLCI = -0.43, ULCI = -0.05).","['participants were 119 adolescents between 11 and 15 years', 'adolescents', 'Adolescents with low or']",['game-based social-emotional programme'],"['emotional intelligence, self-esteem, affect balance, difficulties, prosocial behaviour, depression, anxiety and stress', 'self-esteem', 'self-esteem, affect balance, emotional symptoms, behavioural problems, and hyperactivity', 'medium anxiety improved their self-esteem', 'self-esteem and affect balance (positive β), while their emotional problems and hyperactivity']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]","[{'cui': 'C1510539', 'cui_str': 'Emotional Intelligence'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0677660', 'cui_str': 'Emotional problems'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",119.0,0.0461477,"Anxiety moderated the influence of the intervention on self-esteem (b = .04; t = -2.55; p ≤ .05; LLCI = -0.43, ULCI = -0.05).","[{'ForeName': 'Usue', 'Initials': 'U', 'LastName': 'de la Barrera', 'Affiliation': 'Department of Personality, Assessment and Psychological Treatment, Faculty of Psychology, Universitat de València, Valencia, Spain.'}, {'ForeName': 'Estefanía', 'Initials': 'E', 'LastName': 'Mónaco', 'Affiliation': 'Department of Personality, Assessment and Psychological Treatment, Faculty of Psychology, Universitat de València, Valencia, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Postigo-Zegarra', 'Affiliation': 'Department of Psychology, Faculty of Health Sciences, Universidad Europea de Valencia, Valencia, Spain.'}, {'ForeName': 'José-Antonio', 'Initials': 'JA', 'LastName': 'Gil-Gómez', 'Affiliation': 'Instituto Universitario de Automática e Informática Industrial, Universitat Politècnica de València, Valencia, Spain.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Montoya-Castilla', 'Affiliation': 'Department of Personality, Assessment and Psychological Treatment, Faculty of Psychology, Universitat de València, Valencia, Spain.'}]",PloS one,['10.1371/journal.pone.0250384'] 4102,33861768,"Effect of maternal praziquantel treatment for Schistosoma japonicum infection on the offspring susceptibility and immunologic response to infection at age six, a cohort study.","In areas endemic to schistosomiasis, fetal exposure to schistosome antigens prime the offspring before potential natural infection. Praziquantel (PZQ) treatment for Schistosoma japonicum infection in pregnant women has been demonstrated to be safe and effective. Our objectives were to evaluate whether maternal PZQ treatment modifies the process of in utero sensitization to schistosome antigens potentially impacting later risk of infection, as well as immune response to S. japonicum. We enrolled 295 children at age six, born to mothers with S. japonicum infection who participated in a randomized control trial of PZQ versus placebo given at 12-16 weeks gestation in Leyte, The Philippines. At enrollment, we assessed and treated current S. japonicum infection and measured serum cytokines. During a follow-up visit four weeks later, we assessed peripheral blood mononuclear cell (PBMC) cytokine production in response to soluble worm antigen preparation (SWAP) or soluble egg antigen (SEA). Associations between maternal treatment group and the child's S. japonicum infection status and immunologic responses were determined using multivariate linear regression analysis. PZQ treatment during pregnancy did not impact the prevalence (P = 0.12) or intensity (P = 0.59) of natural S. japonicum infection among children at age six. Among children with infection at enrollment (12.5%) there were no significant serum cytokine concentration differences between maternal treatment groups. Among children with infection at enrollment, IL-1 production by PBMCs stimulated with SEA was higher (P = 0.03) in the maternal PZQ group compared to placebo. Among children without infection, PBMCs stimulated with SEA produced greater IL-12 (P = 0.03) and with SWAP produced less IL-4 (P = 0.01) in the maternal PZQ group compared to placebo. Several cytokines produced by PBMCs in response to SWAP and SEA were significantly higher in children with S. japonicum infection irrespective of maternal treatment: IL-4, IL-5, IL-10, and IL-13. We report that maternal PZQ treatment for S. japonicum shifted the PBMC immune response to a more inflammatory signature but had no impact on their offspring's likelihood of infection or serum cytokines at age six, further supporting the safe use of PZQ in pregnant women. Trial Registration: ClinicalTrials.gov NCT00486863.",2021,"Among children without infection, PBMCs stimulated with SEA produced greater IL-12 (P = 0.03) and with SWAP produced less IL-4 (P = 0.01) in the maternal PZQ group compared to placebo.","['Schistosoma japonicum infection on the offspring susceptibility and immunologic response to infection at age six, a cohort study', 'pregnant women', '295 children at age six, born to mothers with S. japonicum infection who participated in a randomized control trial of']","['Praziquantel (PZQ', 'PZQ versus placebo', 'placebo', 'maternal praziquantel treatment', 'PZQ']","['IL-1 production by PBMCs stimulated with SEA', 'IL-4', ""child's S. japonicum infection status and immunologic responses"", 'serum cytokine concentration differences', 'IL-12', 'peripheral blood mononuclear cell (PBMC) cytokine production in response to soluble worm antigen preparation (SWAP) or soluble egg antigen (SEA']","[{'cui': 'C0036329', 'cui_str': 'Schistosoma japonicum infection'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0152036', 'cui_str': 'Immunology'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0282440', 'cui_str': 'Randomized Controlled Trials as Topic'}]","[{'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0517627', 'cui_str': 'Infection status'}, {'cui': 'C0152036', 'cui_str': 'Immunology'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0018889', 'cui_str': 'Helminth infection'}]",295.0,0.0831824,"Among children without infection, PBMCs stimulated with SEA produced greater IL-12 (P = 0.03) and with SWAP produced less IL-4 (P = 0.01) in the maternal PZQ group compared to placebo.","[{'ForeName': 'Susannah', 'Initials': 'S', 'LastName': 'Colt', 'Affiliation': 'Center for International Health Research, Rhode Island Hospital, The Warren Alpert Medical School of Brown University, Providence, Rhode Island, United States of America.'}, {'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Jarilla', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, The Philippines.'}, {'ForeName': 'Palmera', 'Initials': 'P', 'LastName': 'Baltazar', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, The Philippines.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Tallo', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, The Philippines.'}, {'ForeName': 'Luz P', 'Initials': 'LP', 'LastName': 'Acosta', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, The Philippines.'}, {'ForeName': 'Hannah W', 'Initials': 'HW', 'LastName': 'Wu', 'Affiliation': 'Center for International Health Research, Rhode Island Hospital, The Warren Alpert Medical School of Brown University, Providence, Rhode Island, United States of America.'}, {'ForeName': 'Christopher V', 'Initials': 'CV', 'LastName': 'Barry', 'Affiliation': 'Center for International Health Research, Rhode Island Hospital, The Warren Alpert Medical School of Brown University, Providence, Rhode Island, United States of America.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Kurtis', 'Affiliation': 'Center for International Health Research, Rhode Island Hospital, The Warren Alpert Medical School of Brown University, Providence, Rhode Island, United States of America.'}, {'ForeName': 'Remigio M', 'Initials': 'RM', 'LastName': 'Olveda', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, The Philippines.'}, {'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Friedman', 'Affiliation': 'Center for International Health Research, Rhode Island Hospital, The Warren Alpert Medical School of Brown University, Providence, Rhode Island, United States of America.'}, {'ForeName': 'Mario A', 'Initials': 'MA', 'LastName': 'Jiz', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, The Philippines.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0009328'] 4103,33861669,"""Prospective, Randomized, Controlled Trial of Ultra-modified Internal Sphincterotomy vs Closed Lateral Internal Sphincterotomy for Chronic Fissure-in-Ano"".","BACKGROUND Currently, the lateral internal sphincterotomy is the treatment of choice for a chronic anal fissure (CAF). However, the length of the internal sphincter incision varies, due to lack of standardization. Insufficient length increases the risk of recurrence. To compare a new ultra-modified internal sphincterotomy (UMIS) to the closed lateral internal sphincterotomy (CLIS) for treating CAF, based on internal anal sphincter function and postoperative complications. The primary endpoint was continence after UMIS. The secondary outcomes were CAF healing complications, visual analog scale pain scores, and sphincter pressures. METHODS This was a prospective, randomized, controlled trial (block randomization method). 200 patients with CAFs were randomly assigned to receive either UMIS (n = 100) or the closed lateral internal sphincterotomy (CLIS) (n = 100). Follow-up was 2 years. RESULTS: All (100%) patients in both groups showed clinical improvement at 1 month post-surgery. Recurrences were accompanied by deteriorations in Cleveland Clinic Florida Fecal Incontinence scores at 12 months and 2 years ( P < .05). The groups showed significant differences in fissure healing rates and pain scores. After 1 and 2 years, incontinence rates were significantly higher, and patient satisfaction scores were significantly lower in the CLIS group than the UMIS group ( P < .05). CONCLUSION UMIS provided a faster healing rate and fewer side effects than the CLIS for treating CAFs. These results might lead to a standardized treatment among surgeons.",2021,"After 1 and 2 years, incontinence rates were significantly higher, and patient satisfaction scores were significantly lower in the CLIS group than the UMIS group ( P < .05). ",['200 patients with CAFs'],"['closed lateral internal sphincterotomy (CLIS', 'UMIS', 'Ultra-modified Internal Sphincterotomy vs Closed Lateral Internal Sphincterotomy', 'new ultra-modified internal sphincterotomy (UMIS) to the closed lateral internal sphincterotomy (CLIS']","['CAF healing complications, visual analog scale pain scores, and sphincter pressures', 'risk of recurrence', 'healing rate', 'Cleveland Clinic Florida Fecal Incontinence scores', 'fissure healing rates and pain scores', 'incontinence rates', 'patient satisfaction scores', 'continence after UMIS']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0795907', 'cui_str': 'Conotruncal Anomaly Face Syndrome (CTAF)'}]","[{'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0400249', 'cui_str': 'Lateral sphincterotomy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0349071', 'cui_str': 'Chronic anal fissure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0454845', 'cui_str': 'Cleveland'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0016253', 'cui_str': 'Florida'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332469', 'cui_str': 'Fissure'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0400249', 'cui_str': 'Lateral sphincterotomy'}]",200.0,0.02685,"After 1 and 2 years, incontinence rates were significantly higher, and patient satisfaction scores were significantly lower in the CLIS group than the UMIS group ( P < .05). ","[{'ForeName': 'Ugur', 'Initials': 'U', 'LastName': 'Sungurtekin', 'Affiliation': 'Department of General Surgery, Division of Colon & Rectal Surgery, 64052Pamukkale University School of Medicine, Denizli, Turkey.'}, {'ForeName': 'Utku', 'Initials': 'U', 'LastName': 'Ozgen', 'Affiliation': 'Department of General Surgery, Division of Colon & Rectal Surgery, 64052Pamukkale University School of Medicine, Denizli, Turkey.'}, {'ForeName': 'Hulya', 'Initials': 'H', 'LastName': 'Sungurtekin', 'Affiliation': 'Department of Anesthesiology & Critical Care, 64052Pamukkale University School of Medicine, Denizli, Turkey.'}]",The American surgeon,['10.1177/00031348211011104'] 4104,33861657,"Oral silymarin formulation efficacy in management of AC-T protocol induced hepatotoxicity in breast cancer patients: A randomized, triple blind, placebo-controlled clinical trial.","BACKGROUND Chemotherapeutic agents, with or without other drugs and radiation, may cause indirect or direct hepatotoxicity. Doxorubicin-induced hepatotoxicity (DIH) is a major health concern in cancer patients receiving this cytotoxic drug that is mostly resulted from the production of reactive oxygen species leading to transient or permanent liver damages. Silymarin, a flavonoid extracted from the Silybum marianum , exhibits antioxidant and anti-inflammatory activities. PURPOSE This study aimed to investigate the clinical efficacy of systemic administration of silymarin in management of chemotherapy induced hepatotoxicity in patients with non-metastatic breast cancer who received doxorubicin/cyclophosphamide-paclitaxel (AC-T) regimen.Material: In this randomized, triple blind, placebo-controlled clinical trial, 30 patients who received AC-T who fulfilled the inclusion criteria were randomly allocated to silymarin (n = 15) or placebo (n = 15) groups to receive oral silymarin 140 mg three times a day or placebo tablets, respectively. Fatty liver severity was assessed by liver ultrasound imaging and FibroScan® and also measurement of liver function tests before and after the intervention. RESULTS There was a non-significant trend toward more severe liver involvement in placebo group comparing to the silymarin group after intervention based on ultrasonography (p = 0.083). Besides, in silymarin group, hepatic involvement grade based on ultrasonography considerably reduced after intervention (p = 0.012). However, no difference was found between two groups based on FibroScan and liver function tests. CONCLUSION Oral administration of silymarin could significantly reduce hepatotoxicity severity after 1 month of treatment in non-metastatic breast cancer patients treated with AC-T regimen.",2021,Oral administration of silymarin could significantly reduce hepatotoxicity severity after 1 month of treatment in non-metastatic breast cancer patients treated with AC-T regimen.,"['cancer patients', 'breast cancer patients', 'patients with non-metastatic breast cancer who received', 'Material', 'non-metastatic breast cancer patients', '30 patients who received AC-T who fulfilled the inclusion criteria']","['silymarin', 'doxorubicin/cyclophosphamide-paclitaxel (AC-T) regimen', 'placebo', 'oral silymarin 140\u2009mg three times a day or placebo tablets', 'Doxorubicin-induced hepatotoxicity (DIH']","['hepatotoxicity', 'hepatotoxicity severity', 'FibroScan and liver function tests', 'severe liver involvement', 'Fatty liver severity', 'hepatic involvement grade based on ultrasonography']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0037135', 'cui_str': 'Silymarin'}, {'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}]","[{'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0023901', 'cui_str': 'Hepatic function panel'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0441932', 'cui_str': 'H+'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]",30.0,0.16127,Oral administration of silymarin could significantly reduce hepatotoxicity severity after 1 month of treatment in non-metastatic breast cancer patients treated with AC-T regimen.,"[{'ForeName': 'Ghazal Sadat Askarpour', 'Initials': 'GSA', 'LastName': 'Moezian', 'Affiliation': 'Student Research Committee, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Seyed Alireza', 'Initials': 'SA', 'LastName': 'Javadinia', 'Affiliation': 'Cellular and Molecular Research Center, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Soodabeh Shahid', 'Initials': 'SS', 'LastName': 'Sales', 'Affiliation': 'Cancer Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Azar', 'Initials': 'A', 'LastName': 'Fanipakdel', 'Affiliation': 'Cancer Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Elyasi', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Karimi', 'Affiliation': 'Department of Pharmacodynamics and Toxicology, School of pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners,['10.1177/10781552211006182'] 4105,33861548,Association Between Incident Delirium Treatment With Haloperidol and Mortality in Critically Ill Adults.,"OBJECTIVES Haloperidol is commonly administered in the ICU to reduce the burden of delirium and its related symptoms despite no clear evidence showing haloperidol helps to resolve delirium or improve survival. We evaluated the association between haloperidol, when used to treat incident ICU delirium and its symptoms, and mortality. DESIGN Post hoc cohort analysis of a randomized, double-blind, placebo-controlled, delirium prevention trial. SETTING Fourteen Dutch ICUs between July 2013 and December 2016. PATIENTS One-thousand four-hundred ninety-five critically ill adults free from delirium at ICU admission having an expected ICU stay greater than or equal to 2 days. INTERVENTIONS Patients received preventive haloperidol or placebo for up to 28 days until delirium occurrence, death, or ICU discharge. If delirium occurred, treatment with open-label IV haloperidol 2 mg tid (up to 5 mg tid per delirium symptoms) was administered at clinician discretion. MEASUREMENTS AND MAIN RESULTS Patients were evaluated tid for delirium and coma for 28 days. Time-varying Cox hazards models were constructed for 28-day and 90-day mortality, controlling for study-arm, delirium and coma days, age, Acute Physiology and Chronic Health Evaluation-II score, sepsis, mechanical ventilation, and ICU length of stay. Among the 1,495 patients, 542 (36%) developed delirium within 28 days (median [interquartile range] with delirium 4 d [2-7 d]). A total of 477 of 542 (88%) received treatment haloperidol (2.1 mg [1.0-3.8 mg] daily) for 6 days (3-11 d). Each milligram of treatment haloperidol administered daily was associated with decreased mortality at 28 days (hazard ratio, 0.93; 95% CI, 0.91-0.95) and 90 days (hazard ratio, 0.97; 95% CI, 0.96-0.98). Treatment haloperidol administered later in the ICU course was less protective of death. Results were stable by prevention study-arm, predelirium haloperidol exposure, and haloperidol treatment protocol adherence. CONCLUSIONS Treatment of incident delirium and its symptoms with haloperidol may be associated with a dose-dependent improvement in survival. Future randomized trials need to confirm these results.",2021,"Each milligram of treatment haloperidol administered daily was associated with decreased mortality at 28 days (hazard ratio, 0.93; 95% CI, 0.91-0.95) and 90 days (hazard ratio, 0.97; 95% CI, 0.96-0.98).","['One-thousand four-hundred ninety-five critically ill adults free from delirium at ICU admission having an expected ICU stay greater than or equal to 2 days', 'Fourteen Dutch ICUs between July 2013 and December 2016', 'Critically Ill Adults']","['haloperidol', 'preventive haloperidol or placebo', 'placebo', 'Haloperidol', 'open-label IV haloperidol']","['28-day and 90-day mortality, controlling for study-arm, delirium and coma days, age, Acute Physiology and Chronic Health Evaluation-II score, sepsis, mechanical ventilation, and ICU length of stay', 'protective of death', 'mortality', 'survival', 'delirium']","[{'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}]","[{'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4758051', 'cui_str': 'APACHE II (Acute Physiology and Chronic Health Evaluation II) score'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",1495.0,0.173313,"Each milligram of treatment haloperidol administered daily was associated with decreased mortality at 28 days (hazard ratio, 0.93; 95% CI, 0.91-0.95) and 90 days (hazard ratio, 0.97; 95% CI, 0.96-0.98).","[{'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Duprey', 'Affiliation': '1 Department of Pharmacy and Health Systems Sciences, Bouve College of Health Sciences, Northeastern University, Boston, MA. 2 Department of Intensive Care, Radboud Institute for Health Science, Radboud University Medical Center, Nijmegen, NL. 3 Department of Health Sciences, Bouve College of Health Sciences, Northeastern University, Boston, MA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Devlin', 'Affiliation': ''}, {'ForeName': 'Johannes G', 'Initials': 'JG', 'LastName': 'van der Hoeven', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Pickkers', 'Affiliation': ''}, {'ForeName': 'Becky A', 'Initials': 'BA', 'LastName': 'Briesacher', 'Affiliation': ''}, {'ForeName': 'Jane S', 'Initials': 'JS', 'LastName': 'Saczynski', 'Affiliation': ''}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Griffith', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'van den Boogaard', 'Affiliation': ''}]",Critical care medicine,['10.1097/CCM.0000000000004976'] 4106,31690247,Factors influencing engagement in an online support group for family caregivers of individuals with advanced cancer.,"Objective: To explore factors that influenced engagement in an online support group (OSG) for family caregivers of hospice patients with cancer. Design: Secondary qualitative data analysis. Sample: 58 family caregivers of hospice patients with advanced cancer. Methods: Template analysis of individual family caregiver interviews. Findings: Emotional isolation and caregiving downtime positively influenced engagement, while reluctance to share personal information, a short timeframe of participation in the OSG, and caregiving commitments were negatively influential. While the group facilitation and secure privacy settings of the OSG were viewed positively, reactions to the OSG platform and group tone were mixed. Information on pain and the dying process was found to be particularly engaging. Practice implications: Providers offering OSGs for family caregivers should maximize factors that promote meaningful member engagement, responding to changes in activity and tone over time.",2020,"Emotional isolation and caregiving downtime positively influenced engagement, while reluctance to share personal information, a short timeframe of participation in the OSG, and caregiving commitments were negatively influential.","['58 family caregivers of hospice patients with advanced cancer', 'family caregivers of hospice patients with cancer', 'family caregivers of individuals with advanced cancer']",['online support group (OSG'],[],"[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0019947', 'cui_str': 'Hospice'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0036606', 'cui_str': 'Support Groups'}]",[],58.0,0.122248,"Emotional isolation and caregiving downtime positively influenced engagement, while reluctance to share personal information, a short timeframe of participation in the OSG, and caregiving commitments were negatively influential.","[{'ForeName': 'Karla T', 'Initials': 'KT', 'LastName': 'Washington', 'Affiliation': 'Department of Family and Community Medicine, University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'Debra Parker', 'Initials': 'DP', 'LastName': 'Oliver', 'Affiliation': 'Department of Family and Community Medicine, University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'Jacquelyn J', 'Initials': 'JJ', 'LastName': 'Benson', 'Affiliation': 'Development of Human Development and Family Science, University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'Abigail J', 'Initials': 'AJ', 'LastName': 'Rolbiecki', 'Affiliation': 'Department of Family and Community Medicine, University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'Lucas A', 'Initials': 'LA', 'LastName': 'Jorgensen', 'Affiliation': 'Department of Family and Community Medicine, University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'Dulce M', 'Initials': 'DM', 'LastName': 'Cruz-Oliver', 'Affiliation': 'Department of Medicine, School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Demiris', 'Affiliation': 'Department of Biobehavioral and Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, USA.'}]",Journal of psychosocial oncology,['10.1080/07347332.2019.1680592'] 4107,33864994,The effect of warm salt water foot bath on the management of chemotherapy-induced fatigue.,"PURPOSE Several studies have shown that the warm water bath can be a beneficial approach in the management of fatigue. This experimental study was conducted to evaluate the effect of warm salt water foot bath in the management of chemotherapy-induced fatigue. METHODS This randomized controlled trial was perfomed between November 2017-February 2018. Seventy five patients who experienced moderate or higher level chemotherapy related fatigue were randomly assigned to the intervention or control group. A training booklet about chemotherapy-induced fatigue was given to all patients. In addition, the experimental group performed 20 min warm salt water footbath for a week. The primary outcome was the change in fatigue level over 7 days after chemotherapy. The secondary outcome was the difference in physical, affective, emotional, and cognitive fatigue scores of patients. RESULTS The level of fatigue was grade 2 and grade 3 for 65.3% and 33.3% of patients, respectively. There was no statistically significant difference between groups regarding the mean of total fatigue score before and after bath (p > 0.05). However, the amount of decrease observed in the experimental group was found to be statistically significantly higher than the control group (p = 0.012; p < 0.05). In addition; the score in behavioral/severity, sensory, affective and cognitive dimensions related to fatigue decreased in the experimental group but did not decrease in the control group. CONCLUSION This study shown that warm salt water footbath can be an effective approach in enhancing fatigue related quality of life cancer patients. More studies should be conducted to assess the effectiveness of this intervention.",2021,There was no statistically significant difference between groups regarding the mean of total fatigue score before and after bath (p > 0.05).,"['November 2017-February 2018', 'Seventy five patients who experienced moderate or higher level chemotherapy related fatigue', 'life cancer patients']",['warm salt water foot bath'],"['change in fatigue level', 'level of fatigue', 'score in behavioral/severity, sensory, affective and cognitive dimensions related to fatigue', 'physical, affective, emotional, and cognitive fatigue scores of patients', 'mean of total fatigue score']","[{'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0337055', 'cui_str': 'Salt water'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2586108', 'cui_str': 'Level of fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.0238618,There was no statistically significant difference between groups regarding the mean of total fatigue score before and after bath (p > 0.05).,"[{'ForeName': 'Ferda', 'Initials': 'F', 'LastName': 'Akyuz Ozdemir', 'Affiliation': 'Istanbul University-Cerrahpasa Florence Nightingale Faculty of Nursing, Department of Internal Medical Nursing, Istanbul, Turkey. Electronic address: ferdaakyuz@istanbul.edu.tr.'}, {'ForeName': 'Gulbeyaz', 'Initials': 'G', 'LastName': 'Can', 'Affiliation': 'Istanbul University-Cerrahpasa Florence Nightingale Faculty of Nursing, Department of Internal Medical Nursing, Istanbul, Turkey. Electronic address: gulbeyaz@iuc.edu.tr.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2021.101954'] 4108,33864917,Positive impact of oral hydroxychloroquine and povidone-iodine throat spray for COVID-19 prophylaxis: an open-label randomized trial.,"BACKGROUND We examined whether existing licensed pharmacotherapies could reduce the spread of coronavirus disease 2019 (COVID-19). METHODS An open-label parallel randomized controlled trial was performed among healthy migrant workers quarantined in a large multi-storey dormitory in Singapore. Forty clusters (each defined as individual floors of the dormitory) were randomly assigned to receive a 42-day prophylaxis regimen of either oral hydroxychloroquine (400 mg once, followed by 200 mg/day), oral ivermectin (12 mg once), povidone-iodine throat spray (3 times/day, 270 µg/day), oral zinc (80 mg/day)/vitamin C (500 mg/day) combination, or oral vitamin C, 500 mg/day. The primary outcome was laboratory evidence of SARS-CoV-2 infection as shown by either: (1) a positive serologic test for SARS-CoV-2 antibody on day 42, or (2) a positive PCR test for SARS-CoV-2 at any time between baseline and day 42. RESULTS A total of 3,037 asymptomatic participants (mean age, 33.0 years; all men) who were seronegative to SARS-CoV-2 at baseline were included in the primary analysis. Follow-up was nearly complete (99.6%). Compared with vitamin C, significant absolute risk reductions (%, 98.75% confidence interval) were observed for oral hydroxychloroquine (21%, 2-42%) and povidone-iodine throat spray (24%, 7-39%). No statistically significant differences were observed with oral zinc/vitamin C combination (23%, -5 to +41%) and ivermectin (5%, -10 to +22%). Interruptions due to side effects were highest among participants who received zinc/vitamin C combination (6.9%), followed by vitamin C (4.7%), povidone-iodine (2.0%) and hydroxychloroquine (0.7%). CONCLUSIONS Chemoprophylaxis with either oral hydroxychloroquine or povidone-iodine throat spray was superior to oral vitamin C in reducing SARS-CoV-2 infection in young and healthy men. CLINICALTRIALS. GOV NUMBER NCT04446104.",2021,"Interruptions due to side effects were highest among participants who received zinc/vitamin C combination (6.9%), followed by vitamin C (4.7%), povidone-iodine (2.0%) and hydroxychloroquine (0.7%). ","['3,037 asymptomatic participants (mean age, 33.0 years; all men) who were seronegative to SARS-CoV-2 at baseline were included in the primary analysis', 'Forty clusters (each defined as individual floors of the dormitory', 'young and healthy men', 'healthy migrant workers quarantined in a large multi-storey dormitory in Singapore']","['vitamin C', 'oral hydroxychloroquine', 'povidone-iodine', 'hydroxychloroquine and povidone-iodine throat spray', 'hydroxychloroquine or povidone-iodine throat spray', 'oral ivermectin', 'ivermectin', 'zinc/vitamin C combination', 'povidone-iodine throat spray', 'oral zinc (80\u2009mg/day)/vitamin C (500\u2009mg/day) combination, or oral vitamin C', 'hydroxychloroquine']","['oral zinc/vitamin C combination', 'absolute risk reductions', 'SARS-CoV-2 infection', 'laboratory evidence of SARS-CoV-2 infection']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0521144', 'cui_str': 'Seronegative'}, {'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0026092', 'cui_str': 'Migrant Workers'}, {'cui': 'C0034386', 'cui_str': 'Quarantine'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}]","[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C3654014', 'cui_str': 'Ascorbic acid (vitamin C), combinations'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C3654014', 'cui_str': 'Ascorbic acid (vitamin C), combinations'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}]",3037.0,0.263039,"Interruptions due to side effects were highest among participants who received zinc/vitamin C combination (6.9%), followed by vitamin C (4.7%), povidone-iodine (2.0%) and hydroxychloroquine (0.7%). ","[{'ForeName': 'Raymond Chee Seong', 'Initials': 'RCS', 'LastName': 'Seet', 'Affiliation': 'Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Division of Neurology, Department of Medicine, National University Hospital, Singapore. Electronic address: raymond_seet@nus.edu.sg.'}, {'ForeName': 'Amy May Lin', 'Initials': 'AML', 'LastName': 'Quek', 'Affiliation': 'Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Division of Neurology, Department of Medicine, National University Hospital, Singapore.'}, {'ForeName': 'Delicia Shu Qin', 'Initials': 'DSQ', 'LastName': 'Ooi', 'Affiliation': ""Department of Pediatrics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Division of Pediatric Endocrinology, Khoo Teck Puat-National University Children's Medical Institute, National University Hospital, Singapore.""}, {'ForeName': 'Sharmila', 'Initials': 'S', 'LastName': 'Sengupta', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, National University Hospital, Singapore.'}, {'ForeName': 'Satish Ramapatna', 'Initials': 'SR', 'LastName': 'Lakshminarasappa', 'Affiliation': 'Department of Anatomy, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Chieh Yang', 'Initials': 'CY', 'LastName': 'Koo', 'Affiliation': 'Department of Cardiology, National University Heart Centre, Singapore.'}, {'ForeName': 'Jimmy Bok Yan', 'Initials': 'JBY', 'LastName': 'So', 'Affiliation': 'Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Boon Cher', 'Initials': 'BC', 'LastName': 'Goh', 'Affiliation': 'Department of Hematology-Oncology, National University Cancer Institute, Singapore.'}, {'ForeName': 'Kwok Seng', 'Initials': 'KS', 'LastName': 'Loh', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, National University Hospital, Singapore.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Fisher', 'Affiliation': 'Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Division of Infectious Diseases, Department of Medicine, National University Hospital, Singapore.'}, {'ForeName': 'Hock Luen', 'Initials': 'HL', 'LastName': 'Teoh', 'Affiliation': 'Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Division of Neurology, Department of Medicine, National University Hospital, Singapore.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, Singapore.'}, {'ForeName': 'Alex R', 'Initials': 'AR', 'LastName': 'Cook', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, Singapore.'}, {'ForeName': 'Paul Anantharajah', 'Initials': 'PA', 'LastName': 'Tambyah', 'Affiliation': 'Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Division of Infectious Diseases, Department of Medicine, National University Hospital, Singapore.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Hartman', 'Affiliation': 'Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, Singapore.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2021.04.035'] 4109,33864887,Deproteinization of caries-affected dentin with chemo-mechanical caries removal agents and its effect on dentin bonding with self-etch adhesives.,"OBJECTIVES To evaluate the micro-tensile bond strength (µTBS) of self-etch adhesives (SEA) to normal and caries-affected dentin after smear layer deproteinization with papain enzyme-based and NaOCl-based chemo-mechanical caries removal agents (CRAs) and to compare their efficacy to a 6% NaOCl solution. METHODS Forty extracted human molars with occlusal carious lesions were randomly divided into four pretreatment groups: no treatment (control), Papacarie for 60 s, Carisolv for 60 s, and 6% NaOCl for 15 s. After pretreatment, Universal Bond Quick ER (UBQ, one-step, 1-SEA) or Clearfil SE Bond 2 (CSE, two-step, 2-SEA) was applied to the pre-treated surface, and built-up with resin composite (Clearfil AP-X). The μTBS test was performed after 24 h water storage of the specimens at 37 °C, and the modes of failure were determined under SEM. Deproteinizing effects of the tested agents on smear layer-covered dentin was quantified by changes in the amide:phosphate ratio using attenuated total reflectance Fourier-transform infrared spectroscopy (ATR-FTIR) analysis. RESULTS On caries-affected dentin the µTBS improved significantly after pretreatment with Papacarie, Carisolv, and 6% NaOCl with both SEAs (p < 0.05). Papacarie pretreatment significantly improved the µTBS of UBQ on normal dentin compared to NaOCl pretreatment (p < 0.05). ATR-FTIR revealed that all agents significantly decreased the amide:phosphate ratio on the smear layer-covered normal and caries-affected dentin (p < 0.05). CONCLUSIONS Smear layer deproteinizing with papain enzyme-based and NaOCl-based gel CRAs was effective in improving the micro-tensile bond strength of self-etch adhesives to caries-affected dentin. CLINICAL SIGNIFICANCE Smear layer deproteinization with Papacarie (a papain enzyme-based gel) or Carisolv (a NaOCl-based gel) can improve the µTBS to normal and caries-affected dentin bonded with 2-step self-etch adhesives.",2021,Papacarie pretreatment significantly improved the µTBS of UBQ on normal dentin compared to NaOCl pretreatment (p < 0.05).,"['Forty extracted human molars with occlusal carious lesions', 'normal and caries-affected dentin after smear layer deproteinization with']","['no treatment (control), Papacarie for 60\u2009s, Carisolv for 60\u2009s, and 6% NaOCl for 15\u2009s', 'papain enzyme-based and NaOCl-based gel CRAs', 'Universal Bond Quick ER (UBQ, one-step, 1-SEA) or Clearfil SE Bond 2 (CSE, two-step, 2-SEA', 'micro-tensile bond strength (µTBS) of self-etch adhesives (SEA', 'papain enzyme-based and NaOCl-based chemo-mechanical caries removal agents (CRAs']","['µTBS of UBQ on normal dentin', 'smear layer-covered dentin', 'ATR-FTIR', 'amide:phosphate ratio', 'caries-affected dentin the µTBS']","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0085070', 'cui_str': 'Smear Layer'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1703313', 'cui_str': 'Papacarie'}, {'cui': 'C0769128', 'cui_str': 'Carisolv'}, {'cui': 'C0030346', 'cui_str': 'Papain'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0534010', 'cui_str': 'One-Step dentin bonding system'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C1098526', 'cui_str': 'Clearfil SE Bond'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0085070', 'cui_str': 'Smear Layer'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0282183', 'cui_str': 'Fourier Transform'}, {'cui': 'C0260249', 'cui_str': 'Infrared spectroscopy'}, {'cui': 'C0002482', 'cui_str': 'Amide'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",40.0,0.03109,Papacarie pretreatment significantly improved the µTBS of UBQ on normal dentin compared to NaOCl pretreatment (p < 0.05).,"[{'ForeName': 'Citra', 'Initials': 'C', 'LastName': 'Kusumasari', 'Affiliation': 'Department of Conservative Dentistry, Faculty of Dentistry, University of Indonesia, Jakarta, Indonesia; Department of Cariology and Operative Dentistry, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Abdou', 'Affiliation': 'Department of Cariology and Operative Dentistry, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan; Biomaterials Department, Faculty of Dentistry, Modern University for Technology and Information, Cairo, Egypt. Electronic address: ahmed.abdou@dnt.mti.edu.eg.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Nakajima', 'Affiliation': 'Department of Cariology and Operative Dentistry, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Tagami', 'Affiliation': 'Department of Cariology and Operative Dentistry, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}]",Journal of dentistry,['10.1016/j.jdent.2021.103665'] 4110,33864847,Increasing Readiness for Early Integrated Palliative Oncology Care: Development and Initial Evaluation of the EMPOWER 2 Intervention.,"CONTEXT Early integrated palliative care improves quality of life, but palliative care programs are underutilized. Psychoeducational interventions explaining palliative care may increase patients' readiness for palliative care. OBJECTIVES To (1) collaborate with stakeholders to develop the EMPOWER 2 intervention explaining palliative care, (2) examine acceptability, (3) evaluate feasibility and preliminary efficacy. METHODS The research was conducted at a North American cancer center and involved 21 stakeholders and 10 patient-participants. Investigators and stakeholders iteratively developed the intervention. Stakeholders rated acceptability of the final intervention. Investigators implemented a pre-post trial to examine the feasibility of recruiting 10 patients with metastatic cancer within one month and with a ≥50% consent rate. Preliminary efficacy outcomes were changes in palliative care knowledge and attitudes. RESULTS Using feedback from four stakeholder meetings, we developed a multimedia intervention tailored to three levels of health-literacy. The intervention provides knowledge and reassurance about the purpose and nature of palliative care, addressing cognitive and emotional barriers to utilization. Stakeholders rated the intervention and design process highly acceptable (3.78/4.00). The pilot met a priori feasibility criteria (10 patients enrolled in 14 days; 83.3% consent rate). The intervention increased palliative care knowledge by 83.1% and improved attitudes by 18.9 points on a 0-51 scale (ps<.00001). CONCLUSIONS This formative research outlines the development of a psychoeducational intervention about palliative care. The intervention is acceptable, feasible, and demonstrated promising pilot test results. This study will guide clinical teams in improving patients' readiness for palliative care and inform the forthcoming EMPOWER 3 randomized clinical trial.",2021,"The intervention increased palliative care knowledge by 83.1% and improved attitudes by 18.9 points on a 0-51 scale (ps<.00001). ","['10 patients enrolled in 14 days; 83.3% consent rate', '10 patients with metastatic cancer within one month and with a ≥50% consent rate', 'North American cancer center and involved 21 stakeholders and 10 patient-participants']",['Psychoeducational interventions'],"['palliative care knowledge and attitudes', 'quality of life', 'palliative care knowledge']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0425358', 'cui_str': 'North American origin'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",10.0,0.0498105,"The intervention increased palliative care knowledge by 83.1% and improved attitudes by 18.9 points on a 0-51 scale (ps<.00001). ","[{'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Perry', 'Affiliation': 'Tulane University.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Sartor', 'Affiliation': 'Tulane University.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Malhotra', 'Affiliation': 'Tulane University; University Medical Center New Orleans.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Alonzi', 'Affiliation': 'Tulane University.'}, {'ForeName': 'Seowoo', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Tulane University.'}, {'ForeName': 'Hallie M', 'Initials': 'HM', 'LastName': 'Voss', 'Affiliation': 'Tulane University.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Rogers', 'Affiliation': 'National Cancer Institute.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Robinson', 'Affiliation': 'University of Mississippi Medical Center.'}, {'ForeName': 'Kendra', 'Initials': 'K', 'LastName': 'Harris', 'Affiliation': 'Tulane University.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Shank', 'Affiliation': 'Tulane University.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Morrison', 'Affiliation': 'The Oncology Institute of Hope and Innovation.'}, {'ForeName': 'Ashley B', 'Initials': 'AB', 'LastName': 'Lewson', 'Affiliation': 'Indiana University-Purdue University.'}, {'ForeName': 'Jyotsna', 'Initials': 'J', 'LastName': 'Fuloria', 'Affiliation': 'University Medical Center New Orleans.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Miele', 'Affiliation': 'Louisiana State University Health Sciences Center.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Lewis', 'Affiliation': 'Tulane University.'}, {'ForeName': 'Brenna', 'Initials': 'B', 'LastName': 'Mossman', 'Affiliation': 'Tulane University.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hoerger', 'Affiliation': 'Tulane University; University Medical Center New Orleans. Electronic address: mhoerger@tulane.edu.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2021.03.027'] 4111,33864832,Time-dependent effects of inspiratory muscle training and detraining on cardiac autonomic control in older women.,"Inspiratory muscle training improved maximal inspiratory pressure (MIP) and vagal-mediated heart rate variability (HRV) in older women. However, it is unknown what occurs if the training is discontinued (detraining protocol). The aim of this study was to investigate the IMT and detraining effects on resting HRV in older women. Twelve healthy older women (60-72 yrs) enrolled in home-based IMT at 50% MIP (IMT-group) or placebo at 5% MIP (Sham-group) protocol for 4 weeks using a mechanical pressure threshold loading device. The participants were not engaged in any other exercise protocol at that time. During IMT and Sham interventions, the inspiratory load was adjusted weekly by the actual MIP and resting heart rate variability (HRV) evaluated. After training cessation (4 weeks of detraining), participants returned to the lab for HRV and MIP recordings. Adherence to IMT was superior to 95%. IMT increased MIP (23 ± 8 cmH 2 O) and vagal-mediated HRV (normalized HF; 37 ± 8%), following by the reduction of sympatho-vagal balance (LF/HF), from the second week to the end of the protocol compared to sham-group. After detraining, IMT-group reduced MIP (-23 ± 8 cmH 2 O) and vagal-mediated HRV (normalized HF; -38 ± 14%) returning to baseline values. In conclusion, MIP and vagal-HRV improvements induced by IMT were reversed by four weeks of detraining.",2021,Inspiratory muscle training improved maximal inspiratory pressure (MIP) and vagal-mediated heart rate variability (HRV) in older women.,"['Twelve healthy older women (60-72\u202fyrs) enrolled in', 'older women']","['inspiratory muscle training and detraining', 'IMT', 'Inspiratory muscle training', 'home-based IMT at 50% MIP (IMT-group) or placebo at 5% MIP (Sham-group) protocol for 4\u202fweeks using a mechanical pressure threshold loading device']","['sympatho-vagal balance (LF/HF', 'maximal inspiratory pressure (MIP) and vagal-mediated heart rate variability (HRV', 'cardiac autonomic control', 'IMT increased MIP (23\u202f±\u202f8 cmH 2 O) and vagal-mediated HRV', 'MIP and vagal-HRV improvements induced by IMT']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0334121', 'cui_str': 'Inflammatory myofibroblastic tumor'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0596891', 'cui_str': 'Mechanical pressure'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0334121', 'cui_str': 'Inflammatory myofibroblastic tumor'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0949658', 'cui_str': 'Primary familial hypertrophic cardiomyopathy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",12.0,0.126479,Inspiratory muscle training improved maximal inspiratory pressure (MIP) and vagal-mediated heart rate variability (HRV) in older women.,"[{'ForeName': 'Gabriel Dias', 'Initials': 'GD', 'LastName': 'Rodrigues', 'Affiliation': 'Department of Physiology and Pharmacology, Fluminense Federal University, Niterói, Brazil.'}, {'ForeName': 'Pedro Dal', 'Initials': 'PD', 'LastName': 'Lago', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Ciências da Saúde de Porto Alegre, Brazil.'}, {'ForeName': 'Pedro Paulo', 'Initials': 'PP', 'LastName': 'da Silva Soares', 'Affiliation': 'Department of Physiology and Pharmacology, Fluminense Federal University, Niterói, Brazil. Electronic address: ppssoares@id.uff.br.'}]",Experimental gerontology,['10.1016/j.exger.2021.111357'] 4112,33864830,Effects of 5-aminolevulinic acid with iron supplementation on respiratory responses to graded cycling and interval walking training achievement in older women over 75 yrs.,"BACKGROUND Exercise training above a given intensity is necessary to prevent age-associated physical disability and diseases; however, the physical and psychological barriers posed by deteriorated physical fitness due to aging may hinder older people from performing daily exercise training. Because 5-aminolevulinic acid (ALA), a precursor of heme, reportedly improves mitochondrial function, we examined whether ALA, combined with sodium ferrous citrate (SFC) for enhancement, improved aerobic capacity and voluntary exercise training achievement in older women aged over 75 yrs. METHODS The study was conducted using a placebo-controlled, double-blind crossover design. Fifteen women aged ~78 yrs. with no exercise habits underwent two trials for 7 days each where they performed interval walking training (IWT), repeating fast and slow speeds of walking for 3 min each, at >70% and at ~40% of peak aerobic capacity for walking, respectively, with ALA+SFC (100 and 115 mg/day, respectively) or placebo supplement intake (CNT), with a 12-day washout period. Before and after each trial, subjects underwent a graded cycling test while having their oxygen consumption rate (VO 2 ), carbon dioxide production rate (VCO 2 ), and plasma lactate concentration ([Lac - ] p ) measured. Furthermore, during the supplement intake period, exercise intensity for IWT was measured by accelerometry. RESULTS In ALA+SFC, the increases in VO 2 and VCO 2 during the graded cycling test were attenuated (both, P < 0.01) with a 13% reduction in [Lac - ] p (P = 0.012) while none of these attenuated responses occurred in CNT (all, P > 0.46). Furthermore, energy expenditure and time during fast walking for IWT were 25% (P = 0.032) and 21% (P = 0.022) higher in ALA+SFC than in CNT. CONCLUSION Thus, ALA+SFC supplementation improved aerobic capacity and thus increased fast-walking training achievement in older women.",2021,"Furthermore, energy expenditure and time during fast walking for IWT were 25% (P = 0.032) and 21% (P = 0.022) higher in ALA+SFC than in CNT. ","['older women', 'Fifteen women aged ~78\u202fyrs', 'older women over 75\u202fyrs', 'older women aged over 75\u202fyrs']","['sodium ferrous citrate (SFC', '5-aminolevulinic acid with iron supplementation', 'placebo supplement intake (CNT', '5-aminolevulinic acid (ALA', 'placebo', 'interval walking training (IWT), repeating fast and slow speeds of walking', 'Exercise training', 'ALA+SFC']","['fast-walking training achievement', 'VO 2 and VCO 2 during the graded cycling test', 'Lac - ', 'aerobic capacity', 'oxygen consumption rate (VO 2 ), carbon dioxide production rate (VCO 2 ), and plasma lactate concentration ([Lac - ] p ) measured', 'aerobic capacity and voluntary exercise training achievement', 'respiratory responses to graded cycling and interval walking training achievement', 'energy expenditure and time during fast walking for IWT']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0066752', 'cui_str': 'monoferrous acid citrate'}, {'cui': 'C0002563', 'cui_str': 'Aminolevulinic Acid'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",15.0,0.0452393,"Furthermore, energy expenditure and time during fast walking for IWT were 25% (P = 0.032) and 21% (P = 0.022) higher in ALA+SFC than in CNT. ","[{'ForeName': 'Yasuko', 'Initials': 'Y', 'LastName': 'Ichihara', 'Affiliation': 'Departments of Sports Medical Sciences, Shinshu University Graduate School of Medicine, Matsumoto 390-8621, Japan; Fujimikougen Hospital, Fujimi 399-0214, Japan.'}, {'ForeName': 'Shizue', 'Initials': 'S', 'LastName': 'Masuki', 'Affiliation': 'Departments of Sports Medical Sciences, Shinshu University Graduate School of Medicine, Matsumoto 390-8621, Japan; Institute for Biomedical Sciences, Shinshu University, Matsumoto 390-8621, Japan. Electronic address: masuki@shinshu-u.ac.jp.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Uchida', 'Affiliation': 'Departments of Sports Medical Sciences, Shinshu University Graduate School of Medicine, Matsumoto 390-8621, Japan; Departments of e-Health Sciences, Shinshu University Graduate School of Medicine, Matsumoto 390-8621, Japan.'}, {'ForeName': 'Kiwamu', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of R&D, SBI Pharma Co., Ltd., Tokyo 106-6020, Japan.'}, {'ForeName': 'Motowo', 'Initials': 'M', 'LastName': 'Nakajima', 'Affiliation': 'Department of R&D, SBI Pharma Co., Ltd., Tokyo 106-6020, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nose', 'Affiliation': 'Departments of Sports Medical Sciences, Shinshu University Graduate School of Medicine, Matsumoto 390-8621, Japan; Departments of e-Health Sciences, Shinshu University Graduate School of Medicine, Matsumoto 390-8621, Japan.'}]",Experimental gerontology,['10.1016/j.exger.2021.111356'] 4113,33864754,Intraoperative methylprednisolone and neurodevelopmental outcomes in infants after cardiac surgery.,"BACKGROUND Neurodevelopmental impairment is a significant consequence for survivors of surgery for critical congenital heart disease. This study sought to determine if intraoperative methylprednisolone during neonatal cardiac surgery is associated with neurodevelopmental outcomes at 12 months of age and to identify early prognostic variables associated with neurodevelopmental outcomes. METHODS A planned secondary analysis of a two-center, double-blind, randomized, placebo-controlled trial of intraoperative methylprednisolone in neonates undergoing cardiac surgery was performed. A brain injury biomarker was measured perioperatively. Bayley Scales of Infant and Toddler Development-III (BSID-III) were performed at 12 months of age. Two sample t-tests and generalized linear models were used. RESULTS There were 129 participants (n=61 methylprednisolone, n=68 placebo). There were no significant differences in BSID-III scores and brain injury biomarker levels between the two treatment groups. Participants who underwent a palliative (vs. corrective) procedure had lower mean BSID-III cognitive (101+15 vs. 106+14, p=0.03) and motor scores (85+18 vs. 94+16, p<0.01). Longer ventilation time was associated with lower motor scores. Longer cardiac intensive care unit (CICU) stay was associated with lower cognitive, language, and motor scores. Cardiopulmonary bypass time, aortic cross clamp time, and deep hypothermic circulatory arrest were not associated with BSID-III scores. CONCLUSIONS Neurodevelopmental outcomes were not associated with intraoperative methylprednisolone or intraoperative variables. Participants who underwent a neonatal palliative (vs. corrective) procedure had longer CICU stays and worse neurodevelopmental outcomes at 1 year. This work suggests that interventions focused solely on the operative period may not be associated with a long-term neurodevelopmental benefit.",2021,"Cardiopulmonary bypass time, aortic cross clamp time, and deep hypothermic circulatory arrest were not associated with BSID-III scores. ","['Participants who underwent a neonatal palliative (vs. corrective) procedure had', 'infants after cardiac surgery', '129 participants (n=61', 'neonates undergoing cardiac surgery']","['Intraoperative methylprednisolone', 'placebo', 'methylprednisolone, n=68 placebo', 'intraoperative methylprednisolone']","['Longer cardiac intensive care unit (CICU) stay', 'lower cognitive, language, and motor scores', 'motor scores', 'mean BSID-III cognitive', 'BSID-III scores', 'Cardiopulmonary bypass time, aortic cross clamp time, and deep hypothermic circulatory arrest', 'Bayley Scales of Infant and Toddler Development-III (BSID-III', 'BSID-III scores and brain injury biomarker levels', 'longer CICU stays and worse neurodevelopmental outcomes', 'Longer ventilation time']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0587446', 'cui_str': 'Cardiac intensive care unit'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0429123', 'cui_str': 'Cardiopulmonary bypass time'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1564655', 'cui_str': 'Deep Hypothermic Circulatory Arrest'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]",129.0,0.508083,"Cardiopulmonary bypass time, aortic cross clamp time, and deep hypothermic circulatory arrest were not associated with BSID-III scores. ","[{'ForeName': 'Sinai C', 'Initials': 'SC', 'LastName': 'Zyblewski', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston, SC. Electronic address: chois@musc.edu.'}, {'ForeName': 'Reneé H', 'Initials': 'RH', 'LastName': 'Martin', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Virginia B', 'Initials': 'VB', 'LastName': 'Shipes', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Kasey', 'Initials': 'K', 'LastName': 'Hamlin-Smith', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Atz', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Bradley', 'Affiliation': 'Section of Pediatric Cardiac Surgery, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Minoo N', 'Initials': 'MN', 'LastName': 'Kavarana', 'Affiliation': 'Section of Pediatric Cardiac Surgery, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Mahle', 'Affiliation': ""Department of Pediatrics, Children's Healthcare of Atlanta and Emory University, Atlanta, GA.""}, {'ForeName': 'Allen D', 'Initials': 'AD', 'LastName': 'Everett', 'Affiliation': 'Department of Pediatrics, The Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Graham', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston, SC.'}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2021.04.006'] 4114,33864736,"Safety, tolerability, and immunogenicity of the respiratory syncytial virus prefusion F subunit vaccine DS-Cav1: a phase 1, randomised, open-label, dose-escalation clinical trial.","BACKGROUND Multiple active vaccination approaches have proven ineffective in reducing the substantial morbidity and mortality caused by respiratory syncytial virus (RSV) in infants and older adults (aged ≥65 years). A vaccine conferring a substantial and sustainable boost in neutralising activity is required to protect against severe RSV disease. To that end, we evaluated the safety and immunogenicity of DS-Cav1, a prefusion F subunit vaccine. METHODS In this randomised, open-label, phase 1 clinical trial, the stabilised prefusion F vaccine DS-Cav1 was evaluated for dose, safety, tolerability, and immunogenicity in healthy adults aged 18-50 years at a single US site. Participants were assigned to receive escalating doses of either 50 μg, 150 μg, or 500 μg DS-Cav1 at weeks 0 and 12, and were randomly allocated in a 1:1 ratio within each dose group to receive the vaccine with or without aluminium hydroxide (AlOH) adjuvant. After 71 participants had been randomised, the protocol was amended to allow some participants to receive a single vaccination at week 0. The primary objectives evaluated the safety and tolerability at every dose within 28 days following each injection. Neutralising activity and RSV F-binding antibodies were evaluated from week 0 to week 44 as secondary and exploratory objectives. Safety was assessed in all participants who received at least one vaccine dose; secondary and exploratory immunogenicity analysis included all participants with available data at a given visit. The trial is registered with ClinicalTrials.gov, NCT03049488, and is complete and no longer recruiting. FINDINGS Between Feb 21, 2017, and Nov 29, 2018, 244 participants were screened for eligibility and 95 were enrolled to receive DS-Cav1 at the 50 μg (n=30, of which n=15 with AlOH), 150 μg (n=35, of which n=15 with AlOH), or 500 μg (n=30, of which n=15 with AlOH) doses. DS-Cav1 was safe and well tolerated and no serious vaccine-associated adverse events deemed related to the vaccine were identified. DS-Cav1 vaccination elicited robust neutralising activity and binding antibodies by 4 weeks after a single vaccination (p<0·0001 for F-binding and neutralising antibodies). In analyses of exploratory endpoints at week 44, pre-F-binding IgG and neutralising activity were significantly increased compared with baseline in all groups. At week 44, RSV A neutralising activity was 3·1 fold above baseline in the 50 μg group, 3·8 fold in the 150 μg group, and 4·5 fold in the 500 μg group (p<0·0001). RSV B neutralising activity was 2·8 fold above baseline in the 50 μg group, 3·4 fold in the 150 μg group, and 3·7 fold in the 500 μg group (p<0·0001). Pre-F-binding IgG remained significantly 3·2 fold above baseline in the 50 μg group, 3·4 fold in the 150 μg group, and 4·0 fold in the 500 μg group (p<0·0001). Pre-F-binding serum IgA remained 4·1 fold above baseline in the 50 μg group, 4·3 fold in the 150 μg group, and 4·8 fold in the 500 μg group (p<0·0001). Although a higher vaccine dose or second immunisation elicited a transient advantage compared with lower doses or a single immunisation, neither significantly impacted long-term neutralisation. There was no long-term effect of dose, number of vaccinations, or adjuvant on neutralising activity. INTERPRETATION In this phase 1 study, DS-Cav1 vaccination was safe and well tolerated. DS-Cav1 vaccination elicited a robust boost in RSV F-specific antibodies and neutralising activity that was sustained above baseline for at least 44 weeks. A single low-dose of pre-F immunisation of antigen-experienced individuals might confer protection that extends throughout an entire RSV season. FUNDING The National Institutes of Allergy and Infectious Diseases.",2021,DS-Cav1 was safe and well tolerated and no serious vaccine-associated adverse events deemed related to the vaccine were identified.,"['Between Feb 21, 2017, and Nov 29, 2018', 'infants and older adults (aged ≥65 years', 'n=35, of which n=15 with AlOH), or 500 μg (n=30, of which n=15 with AlOH) doses', '244 participants were screened for eligibility and 95 were enrolled to receive DS-Cav1 at the 50 μg (n=30, of which n=15 with AlOH), 150 μg ', 'healthy adults aged 18-50 years at a single US site', 'participants who received at least one vaccine dose; secondary and exploratory immunogenicity analysis included all participants with available data at a given visit']","['vaccine with or without aluminium hydroxide (AlOH) adjuvant', 'DS-Cav1 vaccination', 'respiratory syncytial virus prefusion F subunit vaccine', 'DS-Cav1']","['F-binding IgG', 'Neutralising activity and RSV F-binding antibodies', 'Safety, tolerability, and immunogenicity', 'RSV B neutralising activity', 'safety, tolerability, and immunogenicity', 'safety and tolerability', 'safety and immunogenicity of DS-Cav1', 'Safety', 'neutralising activity and binding antibodies', 'pre-F-binding IgG and neutralising activity', 'RSV F-specific antibodies and neutralising activity', 'RSV A neutralising activity', 'safe and well tolerated']","[{'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C1527865', 'cui_str': 'CAV1 protein, human'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0002371', 'cui_str': 'Aluminum Hydroxide'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C1527865', 'cui_str': 'CAV1 protein, human'}, {'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0887892', 'cui_str': 'Vaccines, Subunit'}]","[{'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1527865', 'cui_str': 'CAV1 protein, human'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody'}]",244.0,0.352553,DS-Cav1 was safe and well tolerated and no serious vaccine-associated adverse events deemed related to the vaccine were identified.,"[{'ForeName': 'Tracy J', 'Initials': 'TJ', 'LastName': 'Ruckwardt', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA. Electronic address: truckwardt@nih.gov.'}, {'ForeName': 'Kaitlyn M', 'Initials': 'KM', 'LastName': 'Morabito', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Phung', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA; Institute for Biomedical Sciences, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'Crank', 'Affiliation': 'Institute for Asthma and Allergy, Chevy Chase, MD, USA.'}, {'ForeName': 'Pamela J', 'Initials': 'PJ', 'LastName': 'Costner', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'LaSonji A', 'Initials': 'LA', 'LastName': 'Holman', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Chang', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Somia P', 'Initials': 'SP', 'LastName': 'Hickman', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Nina M', 'Initials': 'NM', 'LastName': 'Berkowitz', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Ingelise J', 'Initials': 'IJ', 'LastName': 'Gordon', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Galina V', 'Initials': 'GV', 'LastName': 'Yamshchikov', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Gaudinski', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA; Commissioned Corps, US Public Health Service, Rockville, MD, USA.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Lin', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bailer', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Ortega-Villa', 'Affiliation': 'Biostatistics Research Branch, Division of Clinical Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Thuy', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Azad', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Schwartz', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Kueltzo', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Stein', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Carlton', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jason G', 'Initials': 'JG', 'LastName': 'Gall', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Martha C', 'Initials': 'MC', 'LastName': 'Nason', 'Affiliation': 'Biostatistics Research Branch, Division of Clinical Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Mascola', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Barney S', 'Initials': 'BS', 'LastName': 'Graham', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA. Electronic address: bgraham@nih.gov.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(21)00098-9'] 4115,33864725,Allopurinol for fibromyalgia pain in adults: a randomized controlled trial.,"BACKGROUND Allopurinol is a potent inhibitor of the enzyme xanthine oxidase used in the treatment of hyperuricemia and gout. Since it is well known that purines exert multiple effects on pain transmission, we hypothesized that the inhibition of xanthine oxidase by allopurinol could be a valid strategy to treat pain in humans. This study aimed to compare the analgesic efficacy of oral allopurinol versus placebo as an adjuvant therapy in patients displaying fibromyalgia. METHODS This randomized, double-blinded, placebo-controlled study included 60 women with diagnosis of fibromyalgia. Patients were randomly assigned to receive either oral allopurinol 300 mg (n = 31) or placebo (n = 29) twice daily during 30 days. The patients were submitted to evaluation for pain sensitivity, anxiety, depression and functional status before treatment, 15 and 30 days thereafter. RESULTS Oral administration of allopurinol 300 mg twice daily was ineffective in improving pain scores measured by several tools up to 30 days of treatment (p > 0.05). Additionally, no significant effects of allopurinol over anxiety, depressive symptoms, and functional status of fibromyalgia patients were observed in the present study. CONCLUSIONS Although previous findings indicated that allopurinol could present intrinsic analgesic effects in both animals and humans, this study showed no benefit of the use of oral allopurinol as an adjuvant strategy during 30 days in women displaying fibromyalgia. However, considering previous promising results, new prospective studies are still valid to further investigate allopurinol and more selective purine derivatives in the management of pain syndromes.",2021,300 mg twice daily was ineffective in improving pain scores measured by several tools up to 30 days of treatment (p > 0.05).,"['women displaying fibromyalgia', '60 women with diagnosis of fibromyalgia', 'fibromyalgia pain in adults', 'patients displaying fibromyalgia']","['oral allopurinol', 'placebo', 'allopurinol', 'Allopurinol', 'oral allopurinol versus placebo']","['pain sensitivity, anxiety, depression and functional status', 'intrinsic analgesic effects', 'anxiety, depressive symptoms, and functional status of fibromyalgia patients', 'pain scores', 'analgesic efficacy']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0002144', 'cui_str': 'Allopurinol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",60.0,0.299045,300 mg twice daily was ineffective in improving pain scores measured by several tools up to 30 days of treatment (p > 0.05).,"[{'ForeName': 'Aécio C', 'Initials': 'AC', 'LastName': 'Fagundes', 'Affiliation': 'Department of Biochemistry, Instituto de Ciências Básicas da Saúde (ICBS), Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Enderson D', 'Initials': 'ED', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Biochemistry, Instituto de Ciências Básicas da Saúde (ICBS), Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Samira G', 'Initials': 'SG', 'LastName': 'Ferrari', 'Affiliation': 'Department of Anesthesia and Perioperative Medicine, Hospital de Clínicas de Porto Alegre (HCPA), UFRGS, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Lúcia M M', 'Initials': 'LMM', 'LastName': 'Dos Santos', 'Affiliation': 'Department of Pain and Palliative Care, Hospital de Clínicas de Porto Alegre (HCPA), UFRGS, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Leonardo M', 'Initials': 'LM', 'LastName': 'Botelho', 'Affiliation': 'Department of Pain and Palliative Care, Hospital de Clínicas de Porto Alegre (HCPA), UFRGS, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Sérgio R G', 'Initials': 'SRG', 'LastName': 'Schmidt', 'Affiliation': 'Pain, Pain Relief Center, Medical Center of Hospital Mãe de Deus, S.O.S, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Cristiano F', 'Initials': 'CF', 'LastName': 'Andrade', 'Affiliation': 'Postgraduate Program in Pneumological Sciences, UFRGS, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Diogo R', 'Initials': 'DR', 'LastName': 'Lara', 'Affiliation': 'Cingulo Mental Health App, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Diogo O', 'Initials': 'DO', 'LastName': 'Souza', 'Affiliation': 'Department of Biochemistry, Instituto de Ciências Básicas da Saúde (ICBS), Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.'}, {'ForeName': 'André P', 'Initials': 'AP', 'LastName': 'Schmidt', 'Affiliation': 'Department of Biochemistry, Instituto de Ciências Básicas da Saúde (ICBS), Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.'}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.13019'] 4116,33864710,Is the effect of atorvastatin 60 mg on stabilization of lipid-rich plaque equivalent to that of rosuvastatin 10 mg? A serial optical coherence tomography combined with intravascular ultrasound imaging.,"OBJECTIVES This study aimed to compare the effect of atorvastatin 60 (AT60) mg to that of rosuvastatin 10 (RT10) mg on the morphological changes in lipid-rich plaques (LRPs) and plaque volume, using serial optical coherence tomography (OCT) and intravascular ultrasound imaging (IVUS). BACKGROUND Intensive lipid lowering therapy by statin provides more clinical benefit compared to that of moderate lipid lowering therapy. METHODS Fifty patients who underwent OCT and IVUS at baseline, 6, and 12 months were grouped by statin therapy into the AT60 mg (n = 27) and RT10 mg (n = 23) groups. The relationships between absolute and percentage changes in biomarkers and fibrous cap thickness (FCT) during follow-up were investigated using a simple regression analysis. RESULTS At 6 months, the mean low-density lipoprotein cholesterol level reduced from 113.5 to 65.5 mg/dl (AT60 mg group) and 100.2 to 72.2 mg/dl (RT10 mg groups). A continuous increase in FCT from baseline to 12 months was observed in both groups (p < .001, p < .001, respectively). Mean lipid arc significantly decreased in both AT60 mg (189.0 ± 55.9°, 170.9 ± 60.2°, 155.6 ± 50.6°, p < .001) and RT10 mg (160.0 ± 45.6°, 151.2 ± 48.5°, 141.1 ± 52.9°, p = .010) groups. Plaque burden did not change significantly in both groups. CONCLUSIONS Lipid-lowering therapy effect with AT60 mg was equivalent to that of RT10 mg in terms of change in plaque morphology. AT60 mg showed more intensive low-density lipid cholesterol level reduction compared to RT10 mg while RT10 mg was effective in increasing the high-density lipid cholesterol level. Both statin therapies could effectively stabilize LRPs.",2021,"A continuous increase in FCT from baseline to 12 months was observed in both groups (p < .001, p < .001, respectively).","['Fifty patients who underwent OCT and IVUS at baseline, 6, and 12\u2009months were grouped by']","['serial optical coherence tomography combined with intravascular ultrasound imaging', 'atorvastatin', 'statin therapy', 'rosuvastatin']","['biomarkers and fibrous cap thickness (FCT', 'Plaque burden', 'mean low-density lipoprotein cholesterol level', 'lipid-rich plaques (LRPs) and plaque volume, using serial optical coherence tomography (OCT) and intravascular ultrasound imaging (IVUS', 'intensive low-density lipid cholesterol level reduction', 'FCT', 'high-density lipid cholesterol level', 'Mean lipid arc']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439709', 'cui_str': 'Fibrous'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C4280983', 'cui_str': 'Lipid-rich plaque'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}]",50.0,0.0421955,"A continuous increase in FCT from baseline to 12 months was observed in both groups (p < .001, p < .001, respectively).","[{'ForeName': 'Maoen', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Harbin Medical University, The Key Laboratory of Myocardial Ischemia, Chinese Ministry of Education, Harbin, China.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Demuyakor', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Harbin Medical University, The Key Laboratory of Myocardial Ischemia, Chinese Ministry of Education, Harbin, China.'}, {'ForeName': 'Sining', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Harbin Medical University, The Key Laboratory of Myocardial Ischemia, Chinese Ministry of Education, Harbin, China.'}, {'ForeName': 'Huimin', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Harbin Medical University, The Key Laboratory of Myocardial Ischemia, Chinese Ministry of Education, Harbin, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Harbin Medical University, The Key Laboratory of Myocardial Ischemia, Chinese Ministry of Education, Harbin, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Harbin Medical University, The Key Laboratory of Myocardial Ischemia, Chinese Ministry of Education, Harbin, China.'}, {'ForeName': 'Yuhan', 'Initials': 'Y', 'LastName': 'Qin', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Harbin Medical University, The Key Laboratory of Myocardial Ischemia, Chinese Ministry of Education, Harbin, China.'}, {'ForeName': 'Yishuo', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Harbin Medical University, The Key Laboratory of Myocardial Ischemia, Chinese Ministry of Education, Harbin, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Harbin Medical University, The Key Laboratory of Myocardial Ischemia, Chinese Ministry of Education, Harbin, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zeng', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Harbin Medical University, The Key Laboratory of Myocardial Ischemia, Chinese Ministry of Education, Harbin, China.'}, {'ForeName': 'Ziqian', 'Initials': 'Z', 'LastName': 'Weng', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Harbin Medical University, The Key Laboratory of Myocardial Ischemia, Chinese Ministry of Education, Harbin, China.'}, {'ForeName': 'Zhanqun', 'Initials': 'Z', 'LastName': 'Gao', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Harbin Medical University, The Key Laboratory of Myocardial Ischemia, Chinese Ministry of Education, Harbin, China.'}, {'ForeName': 'Jingbo', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Harbin Medical University, The Key Laboratory of Myocardial Ischemia, Chinese Ministry of Education, Harbin, China.'}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Jia', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Harbin Medical University, The Key Laboratory of Myocardial Ischemia, Chinese Ministry of Education, Harbin, China.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Harbin Medical University, The Key Laboratory of Myocardial Ischemia, Chinese Ministry of Education, Harbin, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Harbin Medical University, The Key Laboratory of Myocardial Ischemia, Chinese Ministry of Education, Harbin, China.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.29654'] 4117,33844620,"Multipass low fluence, high-frequency 755-nm alexandrite laser versus high fluence, low-frequency 1064-nm long-pulsed Nd: YAG laser in axillary hair reduction of dark skin phototypes: an intra-individual randomized comparative study.","BACKGROUND Laser hair removal has become popular means of achieving hair reduction with improved quality of life. OBJECTIVE This study aimed to assess the safety and efficacy of Multipass low fluence, high-frequency 755-nm Alexandrite laser versus the high fluence, low-frequency 1064-nm long-pulsed Nd: YAG laser on axillary hair reduction in women with dark skin phototypes. PATIENTS AND METHODS This study was carried out on 30 adult women [skin type, IV-VI)] who seek axillary hair reduction. These subjects were adjusted to receive 5 laser sessions with a 1-month interval. One side received high fluence, low-frequency 1064-nm laser where the other side received multipass low fluence, high-frequency 755 nm laser. The follow up was done using photographs, folliscope, patients' visual analog pain scale. RESULTS The mean percentage of hair density reduction showed significant improvement in both treated sides being higher in the Alex treated side with corresponding significant decreases in the mean hair thickness. CONCLUSION Multipass low fluence, high-frequency 755-nm Alex laser practice was verified to be safe and effective for hair removal in dark skin phototypes compared to the high fluence, low frequency 1064-nm long pulsed Nd:YAG laser.",2021,"The mean percentage of hair density reduction showed significant improvement in both treated sides being higher in the Alex treated side with corresponding significant decreases in the mean hair thickness. ","['women with dark skin phototypes', '30 adult women [skin type, IV-VI)] who seek axillary hair reduction', 'axillary hair reduction of dark skin phototypes']","['long-pulsed Nd: YAG laser', 'Alexandrite laser versus the high fluence, low-frequency 1064-nm long-pulsed Nd: YAG laser', 'Multipass low fluence, high-frequency 755-nm']","['mean percentage of hair density reduction', 'mean hair thickness', 'visual analog pain scale', 'safety and efficacy']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332582', 'cui_str': 'Dark color'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0221984', 'cui_str': 'Structure of hair of axilla'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0392276', 'cui_str': 'Neodymium-YAG laser'}, {'cui': 'C0392245', 'cui_str': 'Alexandrite laser device'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C4517872', 'cui_str': '755'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",30.0,0.0380551,"The mean percentage of hair density reduction showed significant improvement in both treated sides being higher in the Alex treated side with corresponding significant decreases in the mean hair thickness. ","[{'ForeName': 'Nayera', 'Initials': 'N', 'LastName': 'Moftah', 'Affiliation': 'Ex. Dean of Faculty of Medicine for Girls, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Tymour', 'Affiliation': 'M.B.B.Ch of General Medicine &Surgery, Faculty of Medicine, Cairo University, Giza, Egypt.'}, {'ForeName': 'Shady Mahmoud Attia', 'Initials': 'SMA', 'LastName': 'Ibrahim', 'Affiliation': 'Assistant Professor of Dermatology & Venereology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt.'}]",The Journal of dermatological treatment,['10.1080/09546634.2021.1914311'] 4118,33844589,Did the Randomized Phase III KEYNOTE-181 Study of Pembrolizumab for Esophageal Cancer Yield Negative or Positive Results?,,2021,,[],['Pembrolizumab'],[],[],"[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}]",[],,0.0970476,,"[{'ForeName': 'Hironobu', 'Initials': 'H', 'LastName': 'Minami', 'Affiliation': 'Hironobu Minami, MD, DMedSci, Medical Oncology and Hematology, Kobe University Graduate School of Medicine, Kobe, Japan; Naomi Kiyota, MD, PhD, Cancer Center, Kobe University Hospital, Kobe, Japan and Takashi Omori, PhD, Biostatistics, Social/Community Medicine and Health Science, Kobe University School of Medicine, Kobe, Japan.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Kiyota', 'Affiliation': 'Hironobu Minami, MD, DMedSci, Medical Oncology and Hematology, Kobe University Graduate School of Medicine, Kobe, Japan; Naomi Kiyota, MD, PhD, Cancer Center, Kobe University Hospital, Kobe, Japan and Takashi Omori, PhD, Biostatistics, Social/Community Medicine and Health Science, Kobe University School of Medicine, Kobe, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Omori', 'Affiliation': 'Hironobu Minami, MD, DMedSci, Medical Oncology and Hematology, Kobe University Graduate School of Medicine, Kobe, Japan; Naomi Kiyota, MD, PhD, Cancer Center, Kobe University Hospital, Kobe, Japan and Takashi Omori, PhD, Biostatistics, Social/Community Medicine and Health Science, Kobe University School of Medicine, Kobe, Japan.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.03262'] 4119,33844575,A Deferred-Vaccination Design to Assess Durability of COVID-19 Vaccine Effect After the Placebo Group Is Vaccinated.,"Multiple candidate vaccines to prevent COVID-19 have entered large-scale phase 3 placebo-controlled randomized clinical trials, and several have demonstrated substantial short-term efficacy. At some point after demonstration of substantial efficacy, placebo recipients should be offered the efficacious vaccine from their trial, which will occur before longer-term efficacy and safety are known. The absence of a placebo group could compromise assessment of longer-term vaccine effects. However, by continuing follow-up after vaccination of the placebo group, this study shows that placebo-controlled vaccine efficacy can be mathematically derived by assuming that the benefit of vaccination over time has the same profile for the original vaccine recipients and the original placebo recipients after their vaccination. Although this derivation provides less precise estimates than would be obtained by a standard trial where the placebo group remains unvaccinated, this proposed approach allows estimation of longer-term effect, including durability of vaccine efficacy and whether the vaccine eventually becomes harmful for some. Deferred vaccination, if done open-label, may lead to riskier behavior in the unblinded original vaccine group, confounding estimates of long-term vaccine efficacy. Hence, deferred vaccination via blinded crossover, where the vaccine group receives placebo and vice versa, would be the preferred way to assess vaccine durability and potential delayed harm. Deferred vaccination allows placebo recipients timely access to the vaccine when it would no longer be proper to maintain them on placebo, yet still allows important insights about immunologic and clinical effectiveness over time.",2021,"Deferred vaccination, if done open-label, may lead to riskier behavior in the unblinded original vaccine group, confounding estimates of long-term vaccine efficacy.",[],"['Placebo', 'placebo']","['compromise assessment of longer-term vaccine effects', 'Durability of COVID-19 Vaccine Effect']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]",,0.579662,"Deferred vaccination, if done open-label, may lead to riskier behavior in the unblinded original vaccine group, confounding estimates of long-term vaccine efficacy.","[{'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Follmann', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, Maryland (D.F., J.F., M.P.F., M.N.).'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Fintzi', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, Maryland (D.F., J.F., M.P.F., M.N.).'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Fay', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, Maryland (D.F., J.F., M.P.F., M.N.).'}, {'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Janes', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington (H.E.J., L.N.C., M.J., D.D., Y.F., Y.H., Y.H., O.H., J.G.K.).'}, {'ForeName': 'Lindsey R', 'Initials': 'LR', 'LastName': 'Baden', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (L.R.B.).""}, {'ForeName': 'Hana M', 'Initials': 'HM', 'LastName': 'El Sahly', 'Affiliation': 'Baylor College of Medicine, Houston, Texas (H.M.E.).'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Fleming', 'Affiliation': 'University of Washington, Seattle, Washington (T.R.F., A.L., M.C.).'}, {'ForeName': 'Devan V', 'Initials': 'DV', 'LastName': 'Mehrotra', 'Affiliation': 'Merck & Co., Inc., North Wales, Pennsylvania (D.V.M.).'}, {'ForeName': 'Lindsay N', 'Initials': 'LN', 'LastName': 'Carpp', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington (H.E.J., L.N.C., M.J., D.D., Y.F., Y.H., Y.H., O.H., J.G.K.).'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Juraska', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington (H.E.J., L.N.C., M.J., D.D., Y.F., Y.H., Y.H., O.H., J.G.K.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Benkeser', 'Affiliation': 'Rollins School of Public Health, Emory University, Atlanta, Georgia (D.B.).'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Donnell', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington (H.E.J., L.N.C., M.J., D.D., Y.F., Y.H., Y.H., O.H., J.G.K.).'}, {'ForeName': 'Youyi', 'Initials': 'Y', 'LastName': 'Fong', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington (H.E.J., L.N.C., M.J., D.D., Y.F., Y.H., Y.H., O.H., J.G.K.).'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': 'Moderna, Inc., Cambridge, Massachusetts (S.H., H.Z.).'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Hirsch', 'Affiliation': 'AstraZeneca, Cambridge, United Kingdom (I.H.).'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington (H.E.J., L.N.C., M.J., D.D., Y.F., Y.H., Y.H., O.H., J.G.K.).'}, {'ForeName': 'Yunda', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington (H.E.J., L.N.C., M.J., D.D., Y.F., Y.H., Y.H., O.H., J.G.K.).'}, {'ForeName': 'Ollivier', 'Initials': 'O', 'LastName': 'Hyrien', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington (H.E.J., L.N.C., M.J., D.D., Y.F., Y.H., Y.H., O.H., J.G.K.).'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Luedtke', 'Affiliation': 'University of Washington, Seattle, Washington (T.R.F., A.L., M.C.).'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Carone', 'Affiliation': 'University of Washington, Seattle, Washington (T.R.F., A.L., M.C.).'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Nason', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, Maryland (D.F., J.F., M.P.F., M.N.).'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Vandebosch', 'Affiliation': 'Janssen Pharmaceuticals NV, Beerse, Belgium (A.V.).'}, {'ForeName': 'Honghong', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Moderna, Inc., Cambridge, Massachusetts (S.H., H.Z.).'}, {'ForeName': 'Iksung', 'Initials': 'I', 'LastName': 'Cho', 'Affiliation': 'Novavax, Inc., Gaithersburg, Maryland (I.C.).'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Gabriel', 'Affiliation': 'Karolinska Institutet, Solna, Sweden (E.G.).'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Kublin', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington (H.E.J., L.N.C., M.J., D.D., Y.F., Y.H., Y.H., O.H., J.G.K.).'}, {'ForeName': 'Myron S', 'Initials': 'MS', 'LastName': 'Cohen', 'Affiliation': 'Institute for Global Health and Infectious Diseases, University of North Carolina, Chapel Hill, North Carolina (M.S.C.).'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Corey', 'Affiliation': 'Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington (L.C., P.B.G.).'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Gilbert', 'Affiliation': 'Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington (L.C., P.B.G.).'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Neuzil', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, Maryland (K.M.N.).'}]",Annals of internal medicine,['10.7326/M20-8149'] 4120,33843604,Impact of a Face-To-Face Versus Smartphone App Versus Combined Breastfeeding Intervention Targeting Fathers: Randomized Controlled Trial.,"BACKGROUND Despite the recognized health and economic benefits of exclusive breastfeeding, few Australian infants are exclusively breastfed beyond 5 months of age. Social support for breastfeeding, in particular the support of an infant's father, has been identified as a crucial element for successful breastfeeding. OBJECTIVE The objective of this study was to determine the effectiveness of various father-focused breastfeeding interventions in terms of key infant feeding outcomes. METHODS The study was a 4-arm, factorial, randomized controlled trial conducted in Perth, Australia. The trial arms included a control group and 3 interventions, consisting of a face-to-face father-focused antenatal breastfeeding class facilitated by a male peer facilitator; Milk Man, a breastfeeding smartphone app designed specifically for fathers; and a combination of both interventions. Expecting couples were recruited from hospital-based antenatal classes and block randomized to 1 of the 4 arms. Each partner completed surveys at recruitment and at 6 weeks and 26 weeks postpartum. Primary outcomes were duration of exclusive and any breastfeeding. Secondary outcomes included age of introduction of formula and complementary foods, maternal breastfeeding self-efficacy, and partner postpartum support. RESULTS A total of 1426 couples were recruited from public (443/1426, 31.1%) and private (983/1426, 68.9%) hospitals. Of these, 76.6% (1092/1426) of fathers completed the baseline questionnaire, 58.6% (836/1426) completed the 6-week follow-up questionnaire, and 49.2% (702/1426) completed the 26-week follow-up questionnaire. The average age of fathers who completed the baseline questionnaire was 33.6 (SD 5.2) years; the majority were born in Australia (76.4%) and had attended university (61.8%). There were no significant differences between the control and any of the intervention groups in any of the infant feeding outcomes or level of breastfeeding self-efficacy and postpartum partner support reported by mothers. CONCLUSIONS This study did not demonstrate that any intervention was superior to another or that any intervention was inferior to the standard care delivered in routine antenatal classes. Further studies are needed to test the effectiveness of these interventions in more socioeconomically diverse populations that are likely to benefit most from additional partner supports. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry ACTRN12614000605695; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12614000605695. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) RR2-10.1186/s12884-015-0601-5.",2021,"There were no significant differences between the control and any of the intervention groups in any of the infant feeding outcomes or level of breastfeeding self-efficacy and postpartum partner support reported by mothers. ","['average age of fathers who completed the baseline questionnaire was 33.6 (SD 5.2) years; the majority were born in Australia (76.4%) and had attended university (61.8', 'Targeting Fathers', 'A total of 1426 couples were recruited from public (443/1426, 31.1%) and private (983/1426, 68.9%) hospitals', 'Expecting couples were recruited from hospital-based antenatal classes and block randomized to 1 of the 4 arms']","['Face-To-Face Versus Smartphone App Versus Combined Breastfeeding Intervention', 'control group and 3 interventions, consisting of a face-to-face father-focused antenatal breastfeeding class facilitated by a male peer facilitator; Milk Man, a breastfeeding smartphone app designed specifically for fathers; and a combination of both interventions']","['age of introduction of formula and complementary foods, maternal breastfeeding self-efficacy, and partner postpartum support', 'infant feeding outcomes or level of breastfeeding self-efficacy and postpartum partner support reported by mothers', 'duration of exclusive and any breastfeeding']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4517790', 'cui_str': '5.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1277524', 'cui_str': 'Born in Australia'}, {'cui': 'C0557300', 'cui_str': 'Attending university'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0278373', 'cui_str': 'Class in prenatal exercises'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",1426.0,0.106671,"There were no significant differences between the control and any of the intervention groups in any of the infant feeding outcomes or level of breastfeeding self-efficacy and postpartum partner support reported by mothers. ","[{'ForeName': 'Jane Anne', 'Initials': 'JA', 'LastName': 'Scott', 'Affiliation': 'School of Population Health, Curtin University, Perth, Australia.'}, {'ForeName': 'Sharyn K', 'Initials': 'SK', 'LastName': 'Burns', 'Affiliation': 'School of Population Health, Curtin University, Perth, Australia.'}, {'ForeName': 'Yvonne L', 'Initials': 'YL', 'LastName': 'Hauck', 'Affiliation': 'School of Nursing, Midwifery and Paramedicine, Curtin University, Perth, Australia.'}, {'ForeName': 'Roslyn C', 'Initials': 'RC', 'LastName': 'Giglia', 'Affiliation': 'School of Population Health, Curtin University, Perth, Australia.'}, {'ForeName': 'Anita M', 'Initials': 'AM', 'LastName': 'Jorgensen', 'Affiliation': 'School of Population Health, Curtin University, Perth, Australia.'}, {'ForeName': 'Becky Kate', 'Initials': 'BK', 'LastName': 'White', 'Affiliation': 'School of Population Health, Curtin University, Perth, Australia.'}, {'ForeName': 'Annegret', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'School of Population Health, Curtin University, Perth, Australia.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Robinson', 'Affiliation': 'School of Population Health, Curtin University, Perth, Australia.'}, {'ForeName': 'Satvinder S', 'Initials': 'SS', 'LastName': 'Dhaliwal', 'Affiliation': 'Curtin Health Innovation Research Institute, Curtin University, Perth, Australia.'}, {'ForeName': 'Colin W', 'Initials': 'CW', 'LastName': 'Binns', 'Affiliation': 'School of Population Health, Curtin University, Perth, Australia.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Maycock', 'Affiliation': 'School of Population Health, Curtin University, Perth, Australia.'}]",JMIR pediatrics and parenting,['10.2196/24579'] 4121,33843599,Brief Interventions via Electronic Health Record Messaging for Population-Based Suicide Prevention: Mixed Methods Pilot Study.,"BACKGROUND New opportunities to create and evaluate population-based selective prevention programs for suicidal behavior are emerging in health care settings. Standard depression severity measures recorded in electronic medical records (EMRs) can be used to identify patients at risk for suicide and suicide attempt, and promising interventions for reducing the risk of suicide attempt in at-risk populations can be adapted for web-based delivery in health care. OBJECTIVE This study aims to evaluate a pilot of a psychoeducational program, focused on developing emotion regulation techniques via a web-based dialectical behavior therapy (DBT) skills site, including four DBT skills, and supported by secure message coaching, including elements of caring messages. METHODS Patients were eligible based on the EMR-documented responses to the Patient Health Questionnaire indicating suicidal thoughts. We measured feasibility via the proportion of invitees who opened program invitations, visited the web-based consent form page, and consented; acceptability via qualitative feedback from participants about the DBT program; and engagement via the proportion of invitees who began DBT skills as well as the number of website visits for DBT skills and the degree of site engagement. RESULTS A total of 60 patients were invited to participate. Overall, 93% (56/60) of the patients opened the invitation and 43% (26/60) consented to participate. DBT skills website users visited the home page on an average of 5.3 times (SD 6.0). Procedures resulted in no complaints and some participant feedback emphasizing the usefulness of DBT skills. CONCLUSIONS This study supports the potential of using responses to patient health questionnaires in EMRs to identify a high-risk population and offer key elements of caring messages and DBT adapted for a low-intensity intervention. A randomized trial evaluating the effectiveness of this program is now underway (ClinicalTrials.gov: NCT02326883).",2021,"Standard depression severity measures recorded in electronic medical records (EMRs) can be used to identify patients at risk for suicide and suicide attempt, and promising interventions for reducing the risk of suicide attempt in at-risk populations can be adapted for web-based delivery in health care. ","['Patients were eligible based on the EMR-documented responses to the Patient Health Questionnaire indicating suicidal thoughts', '60 patients were invited to participate']","['psychoeducational program', 'emotion regulation techniques via a web-based dialectical behavior therapy (DBT) skills site, including four DBT skills, and supported by secure message coaching, including elements of caring messages']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1321145', 'cui_str': 'Dialectical behavior therapy'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}]",[],60.0,0.0257766,"Standard depression severity measures recorded in electronic medical records (EMRs) can be used to identify patients at risk for suicide and suicide attempt, and promising interventions for reducing the risk of suicide attempt in at-risk populations can be adapted for web-based delivery in health care. ","[{'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Whiteside', 'Affiliation': 'NowMattersNow.org, Bellevue, WA, United States.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Richards', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States.'}, {'ForeName': 'Gregory E', 'Initials': 'GE', 'LastName': 'Simon', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, United States.'}]",JMIR formative research,['10.2196/21127'] 4122,33843594,De-Implementing Opioid Use and Implementing Optimal Pain Management Following Dental Extractions (DIODE): Protocol for a Cluster Randomized Trial.,"BACKGROUND Overdose deaths from prescription opioid analgesics are a continuing crisis in the United States. Opioid analgesics are among the most frequently prescribed drugs by dentists. An estimated 5 million people undergo third-molar extractions in the United States each year, resulting in postoperative pain. Studies show that, in most cases, the combination of ibuprofen and acetaminophen is an effective alternative to commonly prescribed opioid analgesics for the management of postextraction pain. Nevertheless, many dentists routinely prescribe opioids after dental extractions. OBJECTIVE We describe the rationale, design, and methods for a randomized trial of interventions designed to de-implement opioid prescribing by dentists while implementing effective nonopioid analgesics following dental extractions. METHODS Using a prospective, 3-arm, cluster randomized trial design with dentists as the unit randomized and patient-level prescribing data as the primary outcome, we will compare different strategies to reduce the reliance on opioids and increase the use of alternative pain management approaches utilizing information support tools aimed at both providers and their patients. The study will test the efficacy of 2 interventions to decrease opioid prescribing following dental extractions: clinical decision support with (CDS-E) and without patient education (CDS). Providers will be randomized to CDS, CDS-E, or standard practice. Patient-level outcomes will be determined via review of comprehensive electronic health records. We will compare study arms on differential change in prescribing patterns from pre- to postimplementation of the intervention. The primary outcome of interest is a binary indicator of whether or not the patient received an opioid prescription on the day of the extraction encounter. We will also examine recommendations or prescriptions for nonopioid analgesics, patients' perceptions of shared decision making, and patients' pain experiences following the extraction. RESULTS The HealthPartners Institutional Review Board approved the study. All study materials including the CDS and patient education materials have been developed and pilot tested, and the protocol has been approved by the National Institute of Dental and Craniofacial Research. The intervention was implemented in February 2020, with 51 dentists who were randomized to 1 of the 3 arms. CONCLUSIONS If the intervention strategies are shown to be effective, they could be implemented more broadly in dental settings with high levels of opioid prescribing. TRIAL REGISTRATION ClinicalTrials.gov NCT03584789, https://clinicaltrials.gov/ct2/show/NCT03584789. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/24342.",2021,The study will test the efficacy of 2 interventions to decrease opioid prescribing following dental extractions: clinical decision support with (CDS-E) and without patient education (CDS).,"['February 2020, with 51 dentists who were randomized to 1 of the 3 arms']","['Dental Extractions', 'ibuprofen and acetaminophen']",['postoperative pain'],"[{'cui': 'C0011441', 'cui_str': 'Dentist'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",,0.0949688,The study will test the efficacy of 2 interventions to decrease opioid prescribing following dental extractions: clinical decision support with (CDS-E) and without patient education (CDS).,"[{'ForeName': 'D Brad', 'Initials': 'DB', 'LastName': 'Rindal', 'Affiliation': 'HealthPartners Institute, Bloomington, MN, United States.'}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Asche', 'Affiliation': 'HealthPartners Institute, Bloomington, MN, United States.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Gryczynski', 'Affiliation': 'Friends Research Institute Inc, Baltimore, MD, United States.'}, {'ForeName': 'Sheryl M', 'Initials': 'SM', 'LastName': 'Kane', 'Affiliation': 'HealthPartners Institute, Bloomington, MN, United States.'}, {'ForeName': 'Anjali R', 'Initials': 'AR', 'LastName': 'Truitt', 'Affiliation': 'HealthPartners Institute, Bloomington, MN, United States.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Shea', 'Affiliation': 'HealthPartners Institute, Bloomington, MN, United States.'}, {'ForeName': 'Jeanette Y', 'Initials': 'JY', 'LastName': 'Ziegenfuss', 'Affiliation': 'HealthPartners Institute, Bloomington, MN, United States.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Schwartz', 'Affiliation': 'Friends Research Institute Inc, Baltimore, MD, United States.'}, {'ForeName': 'Donald C', 'Initials': 'DC', 'LastName': 'Worley', 'Affiliation': 'HealthPartners Institute, Bloomington, MN, United States.'}, {'ForeName': 'Shannon G', 'Initials': 'SG', 'LastName': 'Mitchell', 'Affiliation': 'Friends Research Institute Inc, Baltimore, MD, United States.'}]",JMIR research protocols,['10.2196/24342'] 4123,33843593,Combining Web-Based Gamification and Physical Nudges With an App (MoveMore) to Promote Walking Breaks and Reduce Sedentary Behavior of Office Workers: Field Study.,"BACKGROUND Sedentary behavior (SB) and lack of physical activity (PA) have been associated with poorer health outcomes and are increasingly prevalent in individuals working in sedentary occupations such as office jobs. Gamification and nudges have attracted attention as promising strategies to promote changes in health behavior. However, most effectiveness studies thus far lacked active controls, and few studies have tested interventions combining these strategies. OBJECTIVE This study investigates the effectiveness of combining a gamified digital app with physical nudges to increase PA and reduce SB in Dutch office workers. METHODS Employees in the municipality of Rotterdam (N=298) from two office locations were randomized at the location level to either a 10-week intervention, combining a 5-week gamification phase encompassing a gamified digital app with social support features and a 5-week physical nudges phase, or to an active control (ie, basic digital app with self-monitoring and goal setting). The primary outcome was the daily step count, objectively measured via accelerometers. Secondary outcomes were self-reported PA and SB measured at baseline and at 5, 10, and 14 weeks. Mixed effects models were used to analyze the effects of the intervention on the outcome measures. RESULTS A total of 78.5% (234/298) of participants completed the study and provided accelerometer data, whereas 36.9% (110/298) participants completed the self-report measures at 14 weeks. In the gamification phase, step count data were missing for 13.5% (473/3492) of observations in the control and 11.4% (445/3888) in the intervention condition; however, these percentages increased to 39.6% (1154/2910) and 59.6% (1932/3492) at follow-up, respectively. During the gamification phase, intervention participants increased their number of daily steps by 634 (95% CI 154.2-1113.8; P=.01) more than participants in the control group, after controlling for relevant factors. Improvements were not sustained during the physical nudges phase (P=.76) or follow-up (P=.88). CONCLUSIONS A digital intervention with gamification and social support features significantly increased the step count of office workers compared with an active control. Physical nudges in the workplace were insufficient to promote the maintenance of behavioral changes achieved in the gamification phase. Future research should explore the long-term effectiveness of similar gamified digital interventions. TRIAL REGISTRATION International Standard Randomized Controlled Trial Number (ISRCTN) 49129401; https://www.isrctn.com/ISRCTN14881571.",2021,A digital intervention with gamification and social support features significantly increased the step count of office workers compared with an active control.,"['Employees in the municipality of Rotterdam (N=298) from two office locations', 'Dutch office workers']","['10-week intervention, combining a 5-week gamification phase encompassing a gamified digital app with social support features and a 5-week physical nudges phase, or to an active control (ie, basic digital app with self-monitoring and goal setting', 'Combining Web-Based Gamification and Physical Nudges With an App (MoveMore) to Promote Walking Breaks']","['step count of office workers', 'daily step count, objectively measured via accelerometers', 'number of daily steps', 'self-reported PA and SB']","[{'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}]",,0.0601074,A digital intervention with gamification and social support features significantly increased the step count of office workers compared with an active control.,"[{'ForeName': 'André', 'Initials': 'A', 'LastName': 'Mamede', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Gera', 'Initials': 'G', 'LastName': 'Noordzij', 'Affiliation': 'Erasmus University College, Erasmus School of Social and Behavioural Sciences, Erasmus University Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Joran', 'Initials': 'J', 'LastName': 'Jongerling', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Merlijn', 'Initials': 'M', 'LastName': 'Snijders', 'Affiliation': 'Department of Public Health, Welfare and Care, Municipality of Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Schop-Etman', 'Affiliation': 'Erasmus University College, Erasmus School of Social and Behavioural Sciences, Erasmus University Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Semiha', 'Initials': 'S', 'LastName': 'Denktas', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University Rotterdam, Rotterdam, Netherlands.'}]",Journal of medical Internet research,['10.2196/19875'] 4124,33843335,Is randomized trial design adapted to population health intervention research?,"Randomized trials are frequently used in clinical research and considered the gold standard, but they are less common in population health intervention research (PHIR). We discuss issues that are sometimes shared and sometimes distinct between PHIR and clinical research, notably the randomization unit, design, standardization of the intervention, outcome(s) and ethical issues. In the end, both PHIR and clinical research share the common aim of assessing interventions, and randomized trials should be more widely used in PHIR, provided that how they are planned and conducted is adapted to the PHIR context.",2021,"Randomized trials are frequently used in clinical research and considered the gold standard, but they are less common in population health intervention research (PHIR).",[],[],[],[],[],[],,0.0873566,"Randomized trials are frequently used in clinical research and considered the gold standard, but they are less common in population health intervention research (PHIR).","[{'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Giraudeau', 'Affiliation': 'Institut national de la santé et de la recherche médicale (Inserm) U1246, Tours, France.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Alberti', 'Affiliation': 'Institut national de la santé et de la recherche médicale (Inserm) 1123, Paris, France.'}]",Global health promotion,['10.1177/1757975920984727'] 4125,33843329,A comparative assessment of transfer accuracy of two indirect bonding techniques in patients undergoing fixed mechanotherapy: A randomised clinical trial.,"OBJECTIVES To assess the transfer accuracy of three-dimensional (3D) printed transfer trays and compare them with transfer trays made up of polyvinyl siloxane (PVS) for use in indirect bonding. DESIGN This was a two-arm parallel prospective randomised controlled trial. SETTING The trial was undertaken at the outpatient department of a dental college. PARTICIPANTS A total of 30 patients (18 men, 12 women) were randomly allocated to two groups. METHODS The inclusion criteria included patients with permanent and fully erupted dentition (age range = 17-24 years), Angles class I malocclusion with crowding <3 mm requiring non-extraction treatment, good oral hygiene and no previous history of orthodontic treatment. Blinding was applicable only for outcome assessment. Indirect bonding was performed by the primary investigator for both the groups. Digital images of the pre-transfer and post-transfer brackets were obtained by means of an intra-oral scanner and compared using software. Superimpositions of pre- and post-transfer images were done to determine the transfer error for linear and angular variables for all tooth types. RESULTS A total of 600 teeth were bonded, 300 each for both groups. Statistically significant differences were observed in all dimension between the two groups, with 3D-printed trays being more accurate than PVS trays except in the vertical dimension ( P < 0.05). The prevalence of clinically unacceptable transfer errors revealed that most of the transfer errors were in the vertical dimensions for 3D-printed trays. CONCLUSION 3D-printed trays are more accurate than PVS trays except for transfers in vertical dimension.",2021,"Statistically significant differences were observed in all dimension between the two groups, with 3D-printed trays being more accurate than PVS trays except in the vertical dimension ( P < 0.05).","['outpatient department of a dental college', 'A total of 30 patients (18 men, 12 women', 'patients with permanent and fully erupted dentition (age range = 17-24 years), Angles class', 'patients undergoing fixed mechanotherapy', 'I malocclusion with crowding <3 mm requiring non-extraction treatment, good oral hygiene and no previous history of orthodontic treatment']","['indirect bonding techniques', 'polyvinyl siloxane (PVS']",[],"[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0011443', 'cui_str': 'Dentition'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0024636', 'cui_str': 'Malocclusion'}, {'cui': 'C0010383', 'cui_str': 'Crowding'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0457639', 'cui_str': 'Good oral hygiene'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}]","[{'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0078267', 'cui_str': 'vinyl polysiloxane'}]",[],600.0,0.0471996,"Statistically significant differences were observed in all dimension between the two groups, with 3D-printed trays being more accurate than PVS trays except in the vertical dimension ( P < 0.05).","[{'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Chaudhary', 'Affiliation': 'Private Practice, New Delhi, India.'}, {'ForeName': 'Puneet', 'Initials': 'P', 'LastName': 'Batra', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopedics, Institute of Dental Sciences and Technologies, Modi Nagar, Uttar Pradesh, India.'}, {'ForeName': 'Karan', 'Initials': 'K', 'LastName': 'Sharma', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopedics, Institute of Dental Sciences and Technologies, Modi Nagar, Uttar Pradesh, India.'}, {'ForeName': 'Sreevatsan', 'Initials': 'S', 'LastName': 'Raghavan', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopedics, Institute of Dental Sciences and Technologies, Modi Nagar, Uttar Pradesh, India.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Gandhi', 'Affiliation': 'Private Practice, New Delhi, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Srivastava', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopedics, Institute of Dental Sciences and Technologies, Modi Nagar, Uttar Pradesh, India.'}]",Journal of orthodontics,['10.1177/1465312520968571'] 4126,33842881,Increased Leg Strength After Concurrent Aerobic and Resistance Exercise Training in Older Adults Is Augmented by a Whole Food-Based High Protein Diet Intervention.,"Most studies in older adults have utilized powdered protein supplements or oral nutrition solutions as a source of additional dietary protein, but whole foods may provide a greater anabolic stimulus than protein isolated from food matrices. Therefore, the present study investigated a concurrent aerobic and resistance exercise training program in older adults, in the absence or presence of a high protein whole food-based dietary intervention, for effects on strength, physical function, and body composition. Community-dwelling older adults ( n = 56; M/F, 28/28; age, 69.3 ± 4.0 years; BMI, 26.6 ± 3.7 kg m -2 ) participated in a 12-week intervention after randomization to either nutrition only (NUTR; n = 16), exercise only (EX, n = 19), or nutrition plus exercise (NUTR + EX, n = 21) groups. NUTR and NUTR + EX followed a dietary intervention targeting an increase in protein-rich meals at breakfast, lunch, and dinner. Exercise training in EX and NUTR + EX consisted of 24 min sessions of concurrent aerobic and resistance exercise performed three times per week. Daily protein intake increased in NUTR and NUTR + EX, but not EX. The increase in 1RM leg press strength was greater (Interaction effect, P = 0.012) in NUTR + EX [29.6 (18.1, 41.0) kg] than increases observed in NUTR [11.1 (-1.3, 23.6) kg] and EX [12.3 (0.9, 23.8) kg]. The increase in 1RM chest press strength was greater (interaction effect, P = 0.031) in NUTR + EX [6.3 (4.0, 8.6) kg] than the increase observed in NUTR [2.9 (0.3, 5.5) kg], but not EX [6.3 (3.9, 8.7) kg]. Hand-grip strength and sit-to-stand performance were each improved in all three groups, with no differences observed between groups (interaction effect, P = 0.382 and P = 0.671, respectively). An increase in percentage body fat was observed in NUTR, but not in EX or NUTR + EX (interaction effect, P = 0.018). No between-group differences were observed for change in lean body mass (interaction effect, P = 0.402). Concurrent aerobic and resistance exercise training improves strength and physical function in older adults, but combining this training with an increase in daily protein intake through whole foods may be advantageous to increase lower limb strength.",2021,"Hand-grip strength and sit-to-stand performance were each improved in all three groups, with no differences observed between groups (interaction effect, P = 0.382 and P = 0.671, respectively).","['Older Adults', 'Community-dwelling older adults ( n = 56; M/F, 28/28; age, 69.3 ± 4.0 years', 'older adults']","['concurrent aerobic and resistance exercise training program', 'exercise only (EX, n = 19), or nutrition plus exercise (NUTR + EX', 'NUTR and NUTR + EX', 'Concurrent Aerobic and Resistance Exercise Training', 'Concurrent aerobic and resistance exercise training', 'Exercise training in EX and NUTR + EX']","['1RM chest press strength', 'Increased Leg Strength', 'lean body mass', 'NUTR', '1RM leg press strength', 'Daily protein intake increased in NUTR and NUTR + EX', 'protein-rich meals', 'strength, physical function, and body composition', 'strength and physical function', 'percentage body fat', 'Hand-grip strength and sit-to-stand performance']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0444661', 'cui_str': 'Protein-rich meal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}]",,0.00419002,"Hand-grip strength and sit-to-stand performance were each improved in all three groups, with no differences observed between groups (interaction effect, P = 0.382 and P = 0.671, respectively).","[{'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Timmons', 'Affiliation': 'Institute for Sport and Health, School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hone', 'Affiliation': 'School of Health and Human Performance, Dublin City University, Dublin, Ireland.'}, {'ForeName': 'Karl E', 'Initials': 'KE', 'LastName': 'Cogan', 'Affiliation': 'Institute for Sport and Health, School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Orlaith', 'Initials': 'O', 'LastName': 'Duffy', 'Affiliation': 'Medfit Proactive Healthcare, Blackrock Co., Dublin, Ireland.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Egan', 'Affiliation': 'School of Health and Human Performance, Dublin City University, Dublin, Ireland.'}]",Frontiers in sports and active living,['10.3389/fspor.2021.653962'] 4127,33842870,"A randomised, placebo-controlled phase 3 study to evaluate the efficacy and safety of ASP0113, a DNA-based CMV vaccine, in seropositive allogeneic haematopoietic cell transplant recipients.","Background Cytomegalovirus (CMV) is a complication of allogeneic haematopoietic cell transplantation (allo-HCT). ASP0113, a DNA-based vaccine, contains two plasmids encoding human CMV glycoprotein B and phosphoprotein 65 (pp65). We assessed ASP0113 in CMV-seropositive allo-HCT recipients. Methods In this phase 3, randomised, placebo-controlled study, CMV-seropositive allo-HCT recipients were randomly assigned (1:1) via interactive response technology to receive five injections of 1 mL of 5 mg/mL ASP0113 or placebo. The pharmacist and designated staff were unblinded. Masked syringes maintained the blind for patients and study personnel. Efficacy and safety analyses included patients who received ≥1 dose of ASP0113/placebo. The primary efficacy endpoint was the proportion of allo-HCT recipients with composite all-cause mortality and adjudicated CMV end-organ disease (EOD) by 1 year post-transplant. ClinicalTrials.gov: NCT01877655 (not recruiting). Findings Patients were recruited between Sept 11, 2013 and Sept 21, 2016. Overall, 501 patients received ≥1 dose of ASP0113 ( n  = 246) or placebo ( n  = 255). The proportion of patients with composite all-cause mortality and adjudicated CMV EOD by 1 year post-transplant was 35.4% ( n  = 87) with ASP0113 and 30•2% ( n  = 77) with placebo (odds ratio 1.27; 95% confidence interval: 0.87 to 1.85; p  = 0.205). Incidence of injection site-related treatment-emergent adverse events (TEAEs) was higher with ASP0113 than placebo. Overall incidence and severity of other TEAEs was similar between groups. T-cell response to pp65 increased over time and was greater with placebo than ASP0113 ( p  = 0.027). Interpretation ASP0113 did not reduce overall mortality or CMV EOD by 1 year post-transplant. Safety findings were similar between groups. Funding Astellas Pharma Global Development, Inc .",2021,Incidence of injection site-related treatment-emergent adverse events (TEAEs) was higher with ASP0113 than placebo.,"['seropositive allogeneic haematopoietic cell transplant recipients', 'patients who received ≥1 dose of', 'Findings\n\n\nPatients were recruited between Sept 11, 2013 and Sept 21, 2016', 'CMV-seropositive allo-HCT recipients']","['ASP0113/placebo', 'interactive response technology to receive five injections of 1\u202fmL of 5\u202fmg/mL ASP0113 or placebo', '\n\n\nCytomegalovirus (CMV', 'placebo', 'ASP0113', 'ASP0113, a DNA-based CMV vaccine']","['Overall incidence and severity of other TEAEs', 'proportion of patients with composite all-cause mortality and adjudicated CMV EOD', 'T-cell response to pp65', 'proportion of allo-HCT recipients with composite all-cause mortality and adjudicated CMV end-organ disease (EOD', 'overall mortality or CMV EOD']","[{'cui': 'C0521143', 'cui_str': 'Seropositive'}, {'cui': 'C0018957', 'cui_str': 'Hematopoietic system structure'}, {'cui': 'C0206152', 'cui_str': 'Cell Transplants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0206153', 'cui_str': 'Transplantation, Cell'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0000702', 'cui_str': 'A-DNA'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0887903', 'cui_str': 'Cytomegalovirus Vaccines'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0031689', 'cui_str': 'Phosphoproteins'}, {'cui': 'C0018957', 'cui_str': 'Hematopoietic system structure'}, {'cui': 'C0206153', 'cui_str': 'Transplantation, Cell'}]",,0.366029,Incidence of injection site-related treatment-emergent adverse events (TEAEs) was higher with ASP0113 than placebo.,"[{'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ljungman', 'Affiliation': 'Department of Cellular Therapy and Allogeneic Stem Cell Transplantation, Karolinska University Hospital and Division of Hematology, Department of Medicine Huddinge, Karolinska Institutet, SE-14186, Stockholm, Sweden.'}, {'ForeName': 'Arancha', 'Initials': 'A', 'LastName': 'Bermudez', 'Affiliation': 'Department of Hematology, Hospital Universitario Marqués de Valdecilla, Instituto de Formación e Investigación Marqués de Valdecilla, 39008, Santander, Spain.'}, {'ForeName': 'Aaron C', 'Initials': 'AC', 'LastName': 'Logan', 'Affiliation': 'Division of Hematology and Blood and Marrow Transplantation, Department of Medicine, University of California, San Francisco, 94143, San Francisco, United States.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Kharfan-Dabaja', 'Affiliation': 'Department of Blood and Marrow Transplantation, H. Lee Moffitt Cancer Center and Research Institute and University of South Florida, 33612, Tampa, United States.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Chevallier', 'Affiliation': ""Service d'Hématologie Clinique, CHU de Nantes, 44093, Nantes, France and CRCINA / INSERM UMR1232 / CNRS ERL6001 IRS UN - 8 Quai Moncousu - BP 70721, 44007 Nantes cedex 1, France.""}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Martino', 'Affiliation': 'Division of Clinical Hematology, Hospital de la Santa Creu I Sant Pau, 08041, Barcelona, Spain.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Wulf', 'Affiliation': 'Department of Hematology and Medical Oncology, University Medical Center Göttingen, D-37075, Göttingen, Germany.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Selleslag', 'Affiliation': 'Department of Hematology, AZ Sint-Jan Brugge-Oostende, 8000, Brugge, Belgium.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Kakihana', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Komagome Hospital, 113-8677, Tokyo, Japan.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Langston', 'Affiliation': 'Winship Cancer Institute, Emory University, 30322, Atlanta, United States.'}, {'ForeName': 'Dong-Gun', 'Initials': 'DG', 'LastName': 'Lee', 'Affiliation': ""Division of Infectious Diseases, Department of Internal Medicine, Catholic Hematology Hospital and Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 06591, Seoul, Republic of Korea.""}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Solano', 'Affiliation': 'Hematology Service, Hospital Clínico Universitario, Institute of Research INCLIVA and University of Valencia, 46010, Valencia, Spain.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Okamoto', 'Affiliation': 'Division of Hematology, Department of Medicine, Kelo University School of Medicine, 160-8582, Tokyo, Japan.'}, {'ForeName': 'Larry R', 'Initials': 'LR', 'LastName': 'Smith', 'Affiliation': 'Vical Inc., 92121, San Diego, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Boeckh', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center and University of Washington, 98109, Seattle, United States.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Wingard', 'Affiliation': 'Division of Hematology & Oncology, Department of Medicine, University of Florida, 32610, Gainesville, United States.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Cywin', 'Affiliation': 'Astellas Pharma Global Development, Inc., 60062, Northbrook, United States.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Fredericks', 'Affiliation': 'Astellas Pharma Global Development, Inc., 60062, Northbrook, United States.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lademacher', 'Affiliation': 'Astellas Pharma Global Development, Inc., 60062, Northbrook, United States.'}, {'ForeName': 'Xuegong', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Astellas Pharma Global Development, Inc., 60062, Northbrook, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Young', 'Affiliation': 'Astellas Pharma Global Development, Inc., 60062, Northbrook, United States.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Maertens', 'Affiliation': 'Department of Microbiology and Immunology, K.U. Leuven and Department of Hematology, UZ Leuven, Leuven, Belgium.'}]",EClinicalMedicine,['10.1016/j.eclinm.2021.100787'] 4128,33842820,"Synbiotic (FamiLact) administration in idiopathic male infertility enhances sperm quality, DNA integrity, and chromatin status: A triple-blinded randomized clinical trial.","Background Idiopathic male infertility is often treated empirically. A recent body of evidence has indicated the association between pro ± prebiotics administration and improvement in semen parameters. Objective To assess the effect of FamiLact (probiotic + prebiotic) administration on male subjects with idiopathic infertility. Materials and Methods Fifty-six men with idiopathic male infertility were randomly/equally divided into two groups. Men in the case and control groups received 500 mg of FamiLact and an identical placebo for 80 days, respectively. A semen sample was obtained from each of the participants before initiation and after the termination of the treatment course. Samples underwent regular semen analysis and were further analyzed to assess the level of DNA damage (sperm chromatin structure assay), oxidative stress (BODIPY C11 staining), and protamine deficiency (chromomycin-A3 staining) in spermatozoa. Results No significant difference was observed between the baseline values of both groups. After intervention, mean sperm concentration, motility, and normal morphology were significantly higher in the FamiLact group compared to the placebo group (p < 0.05). In the FamiLact receivers, we detected improvement regarding the following parameters: concentration, motility, abnormal morphology, sperm lipid peroxidation, and DNA fragmentation (p ≤ 0.02). Likewise, in the placebo group, we noticed a decrease in the post-medication mean value of DNA fragmentation (p = 0.03) while observing no significant difference regarding other parameters. Conclusion FamiLact administration improves sperm concentration, motility, and abnormal morphology and decrease sperm DNA damage, possibly through alleviating oxidative stress in the seminal fluid.",2021,"In the FamiLact receivers, we detected improvement regarding the following parameters: concentration, motility, abnormal morphology, sperm lipid peroxidation, and DNA fragmentation (p ≤ 0.02).","['male subjects with idiopathic infertility', 'idiopathic male infertility enhances', 'Materials and Methods\n\n\nFifty-six men with idiopathic male infertility']","['FamiLact and an identical placebo', 'placebo', 'Synbiotic (FamiLact) administration', 'FamiLact (probiotic + prebiotic']","['post-medication mean value of DNA fragmentation', 'parameters: concentration, motility, abnormal morphology, sperm lipid peroxidation, and DNA fragmentation', 'sperm quality, DNA integrity, and chromatin status', 'mean sperm concentration, motility, and normal morphology', 'level of DNA damage (sperm chromatin structure assay), oxidative stress (BODIPY C11 staining), and protamine deficiency (chromomycin-A3 staining) in spermatozoa', 'sperm concentration, motility, and abnormal morphology and decrease sperm DNA damage', 'oxidative stress']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0021364', 'cui_str': 'Male infertility'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0376669', 'cui_str': 'DNA Fragmentation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0023775', 'cui_str': 'Lipid peroxidation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0008546', 'cui_str': 'Chromatin'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0429845', 'cui_str': 'Sperm concentration measurement'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0012860', 'cui_str': 'DNA damage'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0381187', 'cui_str': 'BODIPY'}, {'cui': 'C1567160', 'cui_str': 'GZMB protein, human'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0033603', 'cui_str': 'Protamines'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0040563', 'cui_str': 'Chromomycin A3'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",56.0,0.271426,"In the FamiLact receivers, we detected improvement regarding the following parameters: concentration, motility, abnormal morphology, sperm lipid peroxidation, and DNA fragmentation (p ≤ 0.02).","[{'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Abbasi', 'Affiliation': 'Trauma Research Center, AJA University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Homayoun', 'Initials': 'H', 'LastName': 'Abbasi', 'Affiliation': 'Isfahan Fertility and Infertility Center, Isfahan, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Niroumand', 'Affiliation': 'Trauma Research Center, AJA University of Medical Sciences, Tehran, Iran.'}]",International journal of reproductive biomedicine,['10.18502/ijrm.v19i3.8571'] 4129,33842683,Structural MRI of the basal forebrain as predictor of cognitive response to galantamine in healthy older adults-A randomized controlled double-blinded crossover study.,"Introduction Cholinesterase inhibitors can enhance cognitive functions in healthy elderly and delay cognitive decline in patients with Alzheimer`s disease (AD). However, not everyone benefits from this treatment (non-responders). Current studies show clinical meaningful improvements only in one third of AD patients treated with cholinesterase inhibitors. Methods Here we investigate structural magnetic resonance imaging of the basal forebrain cholinergic system volume (BF vol ) as a potential predictor of cognitive response to a single dose of galantamine in healthy adults (n = 18; 59 to 75 years). Results We observed that the cognitive response to galantamine, more specifically the attention-dependent filtering performance in a delayed match-to-sample working memory task, correlated with BF vol : Only participants with high BF vol showed a significant positive effect of galantamine on the ability to filter out distracting information during the working memory encoding process. Discussion Future studies need to assess whether BF vol may serve as a predictor of the galantamine response in AD patients, too.",2021,"Introduction Cholinesterase inhibitors can enhance cognitive functions in healthy elderly and delay cognitive decline in patients with Alzheimer`s disease (AD).","['healthy elderly and delay cognitive decline in patients with Alzheimer`s disease (AD', 'healthy adults (n\xa0=\xa018; 59 to 75 years', 'healthy older adults']","['Cholinesterase inhibitors', 'galantamine', 'basal forebrain cholinergic system volume (BF vol ']","['cognitive response', 'cognitive functions']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0008425', 'cui_str': 'Cholinesterase inhibitor'}, {'cui': 'C0016967', 'cui_str': 'Galantamine'}, {'cui': 'C2331620', 'cui_str': 'Basal Forebrain Area'}, {'cui': 'C0242893', 'cui_str': 'Acetylcholine Agents'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.241003,"Introduction Cholinesterase inhibitors can enhance cognitive functions in healthy elderly and delay cognitive decline in patients with Alzheimer`s disease (AD).","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Müller', 'Affiliation': 'German Centre for Neurodegenerative Diseases Magdeburg Germany.'}, {'ForeName': 'Anne-Katrin', 'Initials': 'AK', 'LastName': 'Vellage', 'Affiliation': 'German Centre for Neurodegenerative Diseases Magdeburg Germany.'}, {'ForeName': 'Marlen', 'Initials': 'M', 'LastName': 'Schmicker', 'Affiliation': 'German Centre for Neurodegenerative Diseases Magdeburg Germany.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Menze', 'Affiliation': 'German Centre for Neurodegenerative Diseases Magdeburg Germany.'}, {'ForeName': 'Michel J', 'Initials': 'MJ', 'LastName': 'Grothe', 'Affiliation': 'German Centre for Neurodegenerative Diseases Rostock Germany.'}, {'ForeName': 'Stefan J', 'Initials': 'SJ', 'LastName': 'Teipel', 'Affiliation': 'German Centre for Neurodegenerative Diseases Rostock Germany.'}, {'ForeName': 'Notger G', 'Initials': 'NG', 'LastName': 'Müller', 'Affiliation': 'German Centre for Neurodegenerative Diseases Magdeburg Germany.'}]","Alzheimer's & dementia (New York, N. Y.)",['10.1002/trc2.12153'] 4130,33842637,Prolonged balloon occlusion of the lower abdominal aorta during pelvic or sacral tumor resection.,"Background To explore the efficacy of lower abdominal aorta balloon occlusion technology in pelvis and sacral tumor surgery and to assess the safety of prolonged balloon occlusion. Methods From January 2008 to January 2017, 81 patients were diagnosed with sacrum or pelvic tumor and underwent surgery in our institution. Balloon catheters were placed through the femoral artery to occlude the abdominal aorta of the pelvic tumor and sacrum region undergoing tumor resection. These patients were divided into two group based on single balloon blocking time. Group A had a balloon blocking time of 60 minutes or less, and group B had a balloon occlusion time greater than 60 minutes. The patients in the two groups were compared with regards to operation time, intraoperative blood loss, blood transfusion volume, average length of hospital stay, and postoperative complications. Results No balloon displacement or leakage of the abdominal aorta occurred during the operations. The difference in operation time between the two groups was statistically significant (P≤0.05), and the differences in intraoperative blood loss, blood transfusion volume, and average hospital stay between groups A and B were not significant (P>0.05). The incidence of postoperative complications was 12% in group A, and 22.6% in group B, with no statistically significant differences (P>0.05). Conclusions Prolonged balloon occlusion was safe and effective in the surgical treatment of complicated pelvic and sacral tumors. It did not increase the incidence of postoperative complications such as distal limb paralysis, arterial thrombosis, or ischemic necrosis.",2021,"The difference in operation time between the two groups was statistically significant (P≤0.05), and the differences in intraoperative blood loss, blood transfusion volume, and average hospital stay between groups A and B were not significant (P>0.05).","['From January 2008 to January 2017, 81 patients were diagnosed with sacrum or pelvic tumor and underwent surgery in our institution']",['Balloon catheters'],"['intraoperative blood loss, blood transfusion volume, and average hospital stay', 'balloon displacement or leakage of the abdominal aorta', 'balloon occlusion time', 'operation time', 'balloon blocking time', 'operation time, intraoperative blood loss, blood transfusion volume, average length of hospital stay, and postoperative complications', 'incidence of postoperative complications', 'incidence of postoperative complications such as distal limb paralysis, arterial thrombosis, or ischemic necrosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036037', 'cui_str': 'Bone structure of sacrum'}, {'cui': 'C0030793', 'cui_str': 'Neoplasm of pelvis'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0441127', 'cui_str': 'Balloon dilatation catheter'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0003484', 'cui_str': 'Abdominal aorta structure'}, {'cui': 'C0887842', 'cui_str': 'Balloon Occlusion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0237766', 'cui_str': 'Hysterical paralysis'}, {'cui': 'C0151942', 'cui_str': 'Arterial thrombosis'}, {'cui': 'C0027543', 'cui_str': 'Avascular necrosis of bone'}]",81.0,0.0367793,"The difference in operation time between the two groups was statistically significant (P≤0.05), and the differences in intraoperative blood loss, blood transfusion volume, and average hospital stay between groups A and B were not significant (P>0.05).","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Mingyan', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'West China School of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'Jianguo', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Min', 'Affiliation': 'Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Tang', 'Affiliation': 'Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Minxun', 'Initials': 'M', 'LastName': 'Lu', 'Affiliation': 'Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yitian', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Duan', 'Affiliation': 'Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Chongqi', 'Initials': 'C', 'LastName': 'Tu', 'Affiliation': 'Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, China.'}]",Annals of translational medicine,['10.21037/atm-21-138'] 4131,33842417,Assessing the Impact of an Intervention Project by the Young women's Christian Association of Malawi on Psychosocial Well-Being of Adolescent Mothers and Their Children in Malawi.,"Adolescent mothers in Malawi face psychosocial challenges such as low resilience level, low self-esteem, poor maternal-infant interaction, and exposure to intimate partner violence (IPV). Children of adolescent mothers often face numerous risks such as low birth-weight, stunted growth, infant death, low school enrolment, increased grade repetition, and dropouts that put them at greater risk of poor developmental outcomes and socio-emotional problems. This study assessed the impact of components of a community project conducted by the Young Women's Christian association of Malawi in providing psychosocial support to adolescent mothers and their children. The goals of the project were; (1) to improve early childhood development in babies born to adolescent mothers; and (2) to enhance the psychosocial well-being of adolescent mothers (self-esteem, resilience stress, and parenting skills). This descriptive mixed methods evaluation study comprised an intervention and control groups of adolescent mothers respectively. The project had 3 centers in southern region districts of Malawi. Target population was adolescent mothers 18 years of age and below. At baseline we enrolled 267 mothers and at the end of the project we had 211 mothers. The project involved monthly meetings with adolescent mothers imparting knowledge and skills and early childhood education activities. From July 2017 to June 2019, 58 sessions were conducted. In the first year the control group had no meetings, however they received the intervention in the second year. Overall results in the intervention group showed statistically significant increase in knowledge on parenting skills ( p < 0.01), nutritional practice ( p < 0.01), motor skills and cognitive functions in children ( p < 0.01) as well as expressive language and socio-emotional capacities in children ( p < 0.01), while the change in confidence and psychosocial well-being was not statistically significant ( p = 0.8823). Community projects such as these enhance parenting skills and improve development of children born to adolescent mothers. Improving psychosocial support is complex and requires further research and a more holistic approach.",2021,"Overall results in the intervention group showed statistically significant increase in knowledge on parenting skills ( p < 0.01), nutritional practice ( p < 0.01), motor skills and cognitive functions in children ( p < 0.01) as well as expressive language and socio-emotional capacities in children ( p < 0.01), while the change in confidence and psychosocial well-being was not statistically significant ( p = 0.8823).","[""Young Women's Christian association of Malawi in providing psychosocial support to adolescent mothers and their children"", 'Adolescent mothers', ""Young women's Christian Association of Malawi on Psychosocial Well-Being of Adolescent Mothers and Their Children in Malawi"", '267 mothers and at the end of the project we had 211 mothers', 'children born to adolescent mothers', 'From July 2017 to June 2019, 58 sessions were conducted', 'adolescent mothers respectively', 'Target population was adolescent mothers 18 years of age and below', 'babies born to adolescent mothers', 'Children of adolescent mothers']",[],"['knowledge on parenting skills', 'nutritional practice', 'motor skills and cognitive functions', 'psychosocial well-being of adolescent mothers (self-esteem, resilience stress, and parenting skills', 'expressive language and socio-emotional capacities']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008532', 'cui_str': 'Christian religion'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C2958078', 'cui_str': 'Psychosocial care'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0039309', 'cui_str': 'Target Population'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]",[],"[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",267.0,0.0138893,"Overall results in the intervention group showed statistically significant increase in knowledge on parenting skills ( p < 0.01), nutritional practice ( p < 0.01), motor skills and cognitive functions in children ( p < 0.01) as well as expressive language and socio-emotional capacities in children ( p < 0.01), while the change in confidence and psychosocial well-being was not statistically significant ( p = 0.8823).","[{'ForeName': 'Mtisunge', 'Initials': 'M', 'LastName': 'Kachingwe', 'Affiliation': ""Young Women's Christian Association of Malawi, Blantyre, Malawi.""}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Chikowe', 'Affiliation': 'Pharmacy Department, College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'van der Haar', 'Affiliation': 'Utrecht Centre for Global Challenges, Utrecht School of Economics, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Nettie', 'Initials': 'N', 'LastName': 'Dzabala', 'Affiliation': ""Young Women's Christian Association of Malawi, Blantyre, Malawi.""}]",Frontiers in public health,['10.3389/fpubh.2021.585517'] 4132,33842412,"Comparison of Caudal Block vs. Penile Block vs. Intravenous Fentanyl Only in Children Undergoing Penile Surgery: A Prospective, Randomized, Double Blind Study.","Objectives: Penile surgery is commonly performed in pediatric surgical centers. There is no consensus regarding which analgesic method is most effective in controlling pain in these children. Methods: Consecutive children between 4 months and 16 years of age who underwent elective penile surgery were recruited. After inhaled induction of anesthesia, children were randomized to one of three methods of intraoperative analgesia: caudal block, IV fentanyl titrated to surgical response and spontaneous respiration, or dorsal penile nerve block (DPNB). All patients were given inhaled agents; fentanyl was added if either block was insufficient. Demographic data, analgesic use and pain scores were recorded by a blinded investigator in the PACU and ward. Pain scores, analgesic requirement, and recovery parameters of returning to normal activity level, eating, and voiding post-operatively for up to 4 days, were compared. Results: 116 children were recruited. Pain scores in the post anesthesia care unit were significantly lower in the DPNB and caudal block groups compared to the fentanyl group for the first 30 postoperative min. Pain scores and analgesic use were subsequently similar among the three groups for the rest of the study period. There was no statistical difference in time to eat, return to normal activity or in parental satisfaction scores among the groups. There was a trend toward earliest time to void in the DPNB group. Conclusions: Regional blocks most effectively controlled pain for 30 min after surgery. The choice of intra-operative analgesia protocol had no effect on later pain and recovery parameters.",2021,Pain scores in the post anesthesia care unit were significantly lower in the DPNB and caudal block groups compared to the fentanyl group for the first 30 postoperative min.,"['Children Undergoing Penile Surgery', 'pediatric surgical centers', '116 children were recruited', 'Consecutive children between 4 months and 16 years of age who underwent elective penile surgery were recruited']","['inhaled agents; fentanyl', 'Penile surgery', 'Caudal Block vs. Penile Block vs. Intravenous Fentanyl', 'intraoperative analgesia: caudal block, IV fentanyl titrated to surgical response and spontaneous respiration, or dorsal penile nerve block (DPNB']","['Pain scores', 'Pain scores, analgesic requirement, and recovery parameters of returning to normal activity level, eating, and voiding post-operatively', 'Pain scores and analgesic use', 'Demographic data, analgesic use and pain scores', 'later pain and recovery parameters', 'time to eat, return to normal activity or in parental satisfaction scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0194682', 'cui_str': 'Operation on penis'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0194682', 'cui_str': 'Operation on penis'}, {'cui': 'C0205097', 'cui_str': 'Caudal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0394769', 'cui_str': 'Local anesthetic penile block'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0412771', 'cui_str': 'Spontaneous respiration'}, {'cui': 'C0228964', 'cui_str': 'Structure of dorsal nerve of penis'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",116.0,0.218377,Pain scores in the post anesthesia care unit were significantly lower in the DPNB and caudal block groups compared to the fentanyl group for the first 30 postoperative min.,"[{'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Ekstein', 'Affiliation': 'Department of Anesthesiology & Critical Care & Pain, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Avi A', 'Initials': 'AA', 'LastName': 'Weinbroum', 'Affiliation': 'Department of Anesthesiology & Critical Care & Pain, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Ben-Chaim', 'Affiliation': 'Department of Pediatric Urology, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Amar', 'Affiliation': 'Department of Orthopedics, Tel-Aviv Medical Center Affiliated With Sackler Medical School, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Reut', 'Initials': 'R', 'LastName': 'Schvartz', 'Affiliation': 'Department of Anesthesiology & Critical Care & Pain, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Yifat', 'Initials': 'Y', 'LastName': 'Klein', 'Affiliation': 'Department of Anesthesiology & Critical Care & Pain, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Yuval', 'Initials': 'Y', 'LastName': 'Bar-Yosef', 'Affiliation': 'Department of Pediatric Urology, Tel Aviv University, Tel Aviv, Israel.'}]",Frontiers in pediatrics,['10.3389/fped.2021.654015'] 4133,33851991,"Outcomes With Surgery vs Functional Bracing for Patients With Closed, Displaced Humeral Shaft Fractures and the Need for Secondary Surgery: A Prespecified Secondary Analysis of the FISH Randomized Clinical Trial.","Importance Existing evidence indicates that surgery fails to provide superior functional outcome over nonoperative care in patients with a closed humeral shaft fracture. However, up to one-third of patients treated nonoperatively may require secondary surgery. Objective To compare the 2-year outcomes of patients who required secondary surgery with the outcomes of patients with successful initial treatment. Design, Setting, and Participants This 2-year follow-up of the Finnish Shaft of the Humerus (FISH) randomized clinical trial comparing surgery with nonoperative treatment (functional brace) was completed in January 2020. Enrollment in the original trial was between November 2012 and January 2018 at 2 university hospital trauma centers in Finland. A total of 321 adult patients with closed, displaced humeral shaft fracture were assessed for eligibility. After excluding patients with cognitive disabilities, multimorbidity, or multiple trauma and those refusing randomization, 82 patients were randomized. Interventions Interventions were surgery with plate fixation (n = 38; initial surgery group) or functional bracing (n = 44); the latter group was divided into the successful fracture healing group (n = 30; bracing group) and the secondary surgery group (n = 14) with fracture healing problems. Main Outcomes and Measures The primary outcome was Disabilities of Arm, Shoulder and Hand (DASH) score at 2 years (range, 0 to 100 points; 0 denotes no disability, 100 extreme disability; minimal clinically important difference, 10 points). Results Of 82 randomized patients, 38 (46%) were female. The mean (SD) age was 48.9 (17.1) years. A total of 74 patients (90%) completed the 2-year follow-up. At 2 years, the mean DASH score was 6.8 (95% CI, 2.3 to 11.4) in the initial surgery group, 6.0 (95% CI, 1.0 to 11.0) in the bracing group, and 17.5 (95% CI, 10.5 to 24.5) in the secondary surgery group. The between-group difference was -10.7 points (95% CI, -19.1 to -2.3; P = .01) between the initial and secondary surgery groups and -11.5 points (95% CI, -20.1 to -2.9; P = .009) between the bracing group and secondary surgery group. Conclusions and Relevance Patients contemplating treatment for closed humeral shaft fracture should be informed that two-thirds of patients treated with functional bracing may heal successfully while one-third may experience fracture healing problems that require secondary surgery and lead to inferior functional outcomes 2 years after the injury. Trial Registration ClinicalTrials.gov Identifier: NCT01719887.",2021,"The primary outcome was Disabilities of Arm, Shoulder and Hand","['Secondary Surgery', 'Patients', '74 patients (90%) completed the 2-year follow-up', '321 adult patients with closed, displaced humeral shaft fracture', 'patients with cognitive disabilities, multimorbidity, or multiple trauma and those refusing randomization, 82 patients were randomized', 'Enrollment in the original trial was between November 2012 and January 2018 at 2 university hospital trauma centers in Finland', 'patients who required secondary surgery with the outcomes of patients with successful initial treatment', '82 randomized patients, 38 (46%) were female', 'patients with a closed humeral shaft fracture']","['surgery with plate fixation (n\u2009=\u200938; initial surgery group) or functional bracing', 'surgery with nonoperative treatment (functional brace', 'successful fracture healing group (n\u2009=\u200930; bracing group) and the secondary surgery group (n\u2009=\u200914) with fracture healing problems']","['mean DASH score', 'Disabilities of Arm, Shoulder and Hand']","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0588210', 'cui_str': 'Bone structure of shaft of humerus'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0026771', 'cui_str': 'Multiple injuries'}, {'cui': 'C0017095', 'cui_str': 'Trash'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1828220', 'cui_str': 'Application of brace'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0438847', 'cui_str': 'Functional brace'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0152231', 'cui_str': 'Fracture, healed'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1997924', 'cui_str': 'Disability of arm'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",321.0,0.239311,"The primary outcome was Disabilities of Arm, Shoulder and Hand","[{'ForeName': 'Lasse', 'Initials': 'L', 'LastName': 'Rämö', 'Affiliation': 'Orthopedics and Traumatology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Paavola', 'Affiliation': 'Orthopedics and Traumatology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Bakir O', 'Initials': 'BO', 'LastName': 'Sumrein', 'Affiliation': 'Orthopedics and Traumatology, University of Tampere and Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Vesa', 'Initials': 'V', 'LastName': 'Lepola', 'Affiliation': 'Orthopedics and Traumatology, University of Tampere and Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Tuomas', 'Initials': 'T', 'LastName': 'Lähdeoja', 'Affiliation': 'Orthopedics and Traumatology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Ranstam', 'Affiliation': 'Mdas AB, Ystad, Sweden.'}, {'ForeName': 'Teppo L N', 'Initials': 'TLN', 'LastName': 'Järvinen', 'Affiliation': 'Orthopedics and Traumatology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Simo', 'Initials': 'S', 'LastName': 'Taimela', 'Affiliation': 'Orthopedics and Traumatology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA surgery,['10.1001/jamasurg.2021.0906'] 4134,33851966,Calcium/Calmodulin-Dependent Protein Kinase II Delta Inhibition and Ventricular Remodeling After Myocardial Infarction: A Randomized Clinical Trial.,"Importance After anterior ST-segment elevation myocardial infarction (STEMI), left ventricular (LV) remodeling results in heart failure and death. Calcium/calmodulin-dependent protein kinase II delta (CaMKIId) is a key molecular mediator of adverse LV remodeling. Objective To determine whether NP202, an orally active inhibitor of CaMKIId, prevents LV remodeling in patients after anterior STEMI with early residual LV dysfunction. Design, Setting, and Participants A randomized, double-blind, placebo-controlled multicenter clinical trial of NP202 vs placebo in patients after primary percutaneous coronary intervention (PCI) for anterior STEMI was performed from November 19, 2015, to August 1, 2018. The study was performed at 32 sites across the US, Australia, and New Zealand. Patients presenting with anterior STEMI who underwent PCI within 12 hours of symptom onset and left ventricular ejection fraction (LVEF) less than 45% on screening echocardiogram 48 hours after primary PCI were included in the study. Baseline cardiovascular magnetic resonance (CMR) imaging was performed within 5 days of the STEMI and before administration of the study drug. Follow-up CMR was performed after 3 months. Data were analyzed from November 19, 2015, to August 1, 2018. Interventions Patients were randomly assigned to NP202, 1000 mg, daily for 3 months vs corresponding placebo. Main Outcomes and Measures The primary end point was change in LV end-systolic volume index (LVESVi) on CMR. Secondary end points were change in LV end-diastolic volume index, change in LVEF, change in infarct size, and change in diastolic function. Safety and tolerability were also assessed. Results A total of 147 patients (mean [SD] age, 58 [11] years; 129 men [88%]; 130 White patients [88%]) who experienced anterior STEMI treated with primary PCI were randomized to receive NP202 (73 [49.7%]) or placebo (74 [50.3%]). Baseline LVEF was similar between groups. At baseline, patients randomized to NP202 had greater LVESVi (48.2 mL/m2) than that in the placebo group (41.3 mL/m2; P = .03). However, the groups were otherwise well matched. For the primary end point of change in LVESVi from baseline to 3 months, there was no significant difference between the placebo (median [interquartile range] change, -0.60 [-9.28 to 5.99] mL/m2) and NP202 groups (-3.53 [-9.24 to 4.81] mL/m2) (P = .78). There was also no difference in the secondary efficacy end points assessed by CMR. NP202 was well tolerated and demonstrated an acceptable safety profile. Major adverse cardiac and cerebrovascular event rates were similar between groups. Two deaths occurred in each group during the follow-up period. Conclusions and Relevance Three months of treatment with NP202 after primary PCI for anterior STEMI with residual LV dysfunction did not improve LV remodeling. The drug was safe and well tolerated. Trial Registration ClinicalTrials.gov Identifier: NCT02557217.",2021,Major adverse cardiac and cerebrovascular event rates were similar between groups.,"['patients after primary percutaneous coronary intervention (PCI) for anterior STEMI was performed from November 19, 2015, to August 1, 2018', '147 patients (mean [SD] age, 58', 'patients after anterior STEMI with early residual LV dysfunction', 'Patients presenting with anterior STEMI who underwent PCI within 12 hours of symptom onset and left ventricular ejection fraction (LVEF) less than 45% on screening echocardiogram 48 hours after primary PCI were included in the study', '11] years; 129 men [88%]; 130 White patients [88%]) who experienced anterior STEMI treated with primary PCI']","['Calcium/Calmodulin-Dependent Protein Kinase II Delta Inhibition and Ventricular Remodeling', 'NP202 vs placebo', 'Calcium/calmodulin-dependent protein kinase II delta (CaMKIId', 'placebo', 'NP202']","['LV remodeling', 'Major adverse cardiac and cerebrovascular event rates', 'LVESVi', 'change in LV end-systolic volume index (LVESVi) on CMR', 'Baseline LVEF', 'change in LV end-diastolic volume index, change in LVEF, change in infarct size, and change in diastolic function', 'Safety and tolerability', 'safe and well tolerated']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0003153', 'cui_str': 'Anterior eyeball segment structure'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0242698', 'cui_str': 'Impaired left ventricular function'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0769224', 'cui_str': 'Calcium/calmodulin-dependent protein kinase'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0600519', 'cui_str': 'Ventricular remodelling'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0248868', 'cui_str': 'Calmodulin-Dependent Protein Kinase II'}]","[{'cui': 'C0600520', 'cui_str': 'Left Ventricular Remodeling'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0455832', 'cui_str': 'Left ventricular end-systolic cavity size'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0455833', 'cui_str': 'Left ventricular end-diastolic cavity size'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",147.0,0.580417,Major adverse cardiac and cerebrovascular event rates were similar between groups.,"[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Boyle', 'Affiliation': 'Department of Cardiovascular Medicine, John Hunter Hospital, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Schultz', 'Affiliation': 'University of Western Australia School of Medicine, Perth, Australia.'}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Selvanayagam', 'Affiliation': 'Flinders Medical Centre, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Moir', 'Affiliation': 'MonashHeart, Melbourne, Victoria, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kovacs', 'Affiliation': 'Krannert Institute of Cardiology, Indianapolis, Indiana.'}, {'ForeName': 'Nabil', 'Initials': 'N', 'LastName': 'Dib', 'Affiliation': 'Dignity Healthcare, Gilbert, Arizona.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Zlotnick', 'Affiliation': 'University of Buffalo, Buffalo, New York.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Al-Omary', 'Affiliation': 'Department of Cardiovascular Medicine, John Hunter Hospital, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Sugito', 'Affiliation': 'Department of Cardiovascular Medicine, John Hunter Hospital, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Aravinda', 'Initials': 'A', 'LastName': 'Selvarajah', 'Affiliation': 'Department of Cardiovascular Medicine, John Hunter Hospital, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Collins', 'Affiliation': 'Department of Cardiovascular Medicine, John Hunter Hospital, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'McLachlan', 'Affiliation': 'Armaron Bio, Melbourne, Victoria, Australia.'}]",JAMA cardiology,['10.1001/jamacardio.2021.0676'] 4135,33864607,Changes in white adipose tissue gene expression in a randomized control trial of dieting obese men with lowered serum testosterone alone or in combination with testosterone treatment.,"PURPOSE The aim of this study was to determine early weight loss-associated changes in subcutaneous abdominal white adipose tissue (WAT) gene expression in obese men with lowered serum testosterone by RNA next-generation sequencing. METHODS Fourteen men, mean age (IQR) 51.6 years (43.4-54.5), BMI 38.3 kg/m 2 (34.6-40.8) and total testosterone 8.4 nmol/L (7.5-9.5) provided subcutaneous WAT samples at baseline and after 2 weeks of a very low energy diet. RESULTS Body weight loss was similar in participants receiving testosterone (n = 6), -5.27 kg [95% CI -6.17; -4.26], and placebo (n = 8), -4.57 kg [95% CI -6.10; -3.55], p = 0.86. In placebo-treated men, of the 14,410 genes expressed in subcutaneous WAT, four genes, Angiopoietin-like 4, Semaphorin 3 G, Neuropilin 2 and Angiopoietin 4, were upregulated (adjusted false discovery rate P < 0.05). In an exploratory analysis comparing men receiving testosterone and placebo, the most-upregulated gene in the testosterone group (exploratory p < 0.0005) was the neuropeptide y receptor 2. CONCLUSIONS In obese men, dieting is associated with upregulation of WAT-expressed Angiopoietin-like 4, a secreted protein that regulates lipid metabolism, Semaphorin 3 G, a proposed adipocyte differentiation factor and secreted adipokine, and its receptor Neuropilin 2, as well as Angiopoietin 4, a vascular integrity factor. In an exploratory analysis, testosterone was associated with the upregulation of neuropeptide y receptor 2, a receptor involved in appetite regulation. Further studies are needed to confirm these observations and their potential biological implications. TRIAL REGISTRATION clinicaltrials.gov, Identifier NCT01616732, Registration date: June 8, 2012.",2021,"In an exploratory analysis, testosterone was associated with the upregulation of neuropeptide y receptor 2, a receptor involved in appetite regulation.","['obese men with lowered serum testosterone by RNA next-generation sequencing', 'Fourteen men, mean age (IQR) 51.6 years (43.4-54.5), BMI 38.3\u2009kg/m 2 (34.6-40.8) and total testosterone 8.4\u2009nmol/L (7.5-9.5) provided subcutaneous WAT samples at baseline and after 2 weeks of a very low energy diet', 'dieting obese men with lowered serum testosterone alone or in combination with testosterone treatment']","['testosterone', 'placebo', 'testosterone and placebo']","['Body weight loss', 'early weight loss']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0428413', 'cui_str': 'Serum testosterone measurement'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C2936621', 'cui_str': 'Next-Generation Sequencing'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0202227', 'cui_str': 'Testosterone measurement, total'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0439282', 'cui_str': 'nmol/L'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1704223', 'cui_str': 'White Adipose Tissue'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0452268', 'cui_str': 'Very low energy diet'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.304241,"In an exploratory analysis, testosterone was associated with the upregulation of neuropeptide y receptor 2, a receptor involved in appetite regulation.","[{'ForeName': 'Mathis', 'Initials': 'M', 'LastName': 'Grossmann', 'Affiliation': 'Department of Medicine Austin Health, University of Melbourne, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Mark Ng Tang', 'Initials': 'MNT', 'LastName': 'Fui', 'Affiliation': 'Department of Medicine Austin Health, University of Melbourne, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Nie', 'Affiliation': 'Department of Medicine Austin Health, University of Melbourne, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Hoermann', 'Affiliation': 'Department of Medicine Austin Health, University of Melbourne, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Michele V', 'Initials': 'MV', 'LastName': 'Clarke', 'Affiliation': 'Department of Medicine Austin Health, University of Melbourne, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Ada S', 'Initials': 'AS', 'LastName': 'Cheung', 'Affiliation': 'Department of Medicine Austin Health, University of Melbourne, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Zajac', 'Affiliation': 'Department of Medicine Austin Health, University of Melbourne, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Davey', 'Affiliation': 'Department of Medicine Austin Health, University of Melbourne, Heidelberg, Victoria, Australia. r.davey@unimelb.edu.au.'}]",Endocrine,['10.1007/s12020-021-02722-0'] 4136,33864595,Maternal Health Outcomes and Male Partner Involvement Among HIV Infected Women in Rural South Africa.,"INTRODUCTION This study aimed to investigate the association between Male Partner Involvement (MPI) and maternal health outcomes among women attending Prevention of Mother-to-Child Transmission of HIV (PMTCT) services in rural South Africa. The association between Male Partner Participation in the main study (MPP) and maternal health outcomes among these women was also investigated. METHODS The study utilized data collected from 535 HIV infected women in a randomized controlled trial between 2015 and 2016. Maternal health outcome data (delivery mode, pregnancy systolic and diastolic blood pressure, pregnancy body mass index, pregnancy CD4 count, and pregnancy viral load) were collected from the women's antenatal record forms accessed from the primary healthcare facilities. Bivariate and multivariable logistic regression models were used to estimate the association between socio-demographic characteristics of the women, MPI, and MPP with maternal health outcomes. RESULTS The mean age of the women was 29.03 years (SD = 5.89). No significant associations were found between MPI and any of the maternal health outcomes contrary to what was hypothesized. Both the bivariate and multivariate analysis indicated a significant association between MPP and higher pregnancy viral load, contrary to the study hypothesis. Insignificant associations were found between MPP and both pregnancy CD4 count and pregnancy blood pressure. The only significant association between maternal health outcomes and socio-demographic characteristics, was between educational attainment and higher pregnancy CD4 count in both the bivariate and multivariate analysis. CONCLUSION FOR PRACTICE The study showed no significant support for MPI in improving maternal health outcomes of women in PMTCT in rural South Africa. Future studies should include additional maternal health outcomes for investigation.",2021,The study showed no significant support for MPI in improving maternal health outcomes of women in PMTCT in rural South Africa.,"['women in PMTCT in rural South Africa', 'women attending Prevention of Mother-to-Child Transmission of HIV (PMTCT) services in rural South Africa', '535 HIV infected women in a randomized controlled trial between 2015 and 2016', 'HIV Infected Women in Rural South Africa']",[],"['maternal health outcomes and socio-demographic characteristics', 'Maternal Health Outcomes and Male Partner Involvement', 'maternal health outcomes', 'MPP and both pregnancy CD4 count and pregnancy blood pressure', 'educational attainment and higher pregnancy CD4 count', 'Maternal health outcome data (delivery mode, pregnancy systolic and diastolic blood pressure, pregnancy body mass index, pregnancy CD4 count, and pregnancy viral load']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0282474', 'cui_str': 'Infection Transmission, Maternal-Fetal'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0024921', 'cui_str': 'Maternal Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}]",,0.191976,The study showed no significant support for MPI in improving maternal health outcomes of women in PMTCT in rural South Africa.,"[{'ForeName': 'Motlagabo Gladys', 'Initials': 'MG', 'LastName': 'Matseke', 'Affiliation': 'Department of Work and Social Psychology, Maastricht University, P.O. Box 616.6200 MD, Maastricht, the Netherlands. mgsmatseke@gmail.com.'}, {'ForeName': 'Robert A C', 'Initials': 'RAC', 'LastName': 'Ruiter', 'Affiliation': 'Department of Work and Social Psychology, Maastricht University, P.O. Box 616.6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'Violeta J', 'Initials': 'VJ', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, 1400 NW 10th Ave., Miami, FL, 33136, USA.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Peltzer', 'Affiliation': 'Department of Research & Innovation, University of Limpopo, Sovenga, South Africa.'}, {'ForeName': 'Sibusiso', 'Initials': 'S', 'LastName': 'Sifunda', 'Affiliation': 'HIV/AIDS, STIs, & TB Research Programme, Human Sciences Research Council, 134 Pretorius Street, Pretoria, 0001, South Africa.'}]",Maternal and child health journal,['10.1007/s10995-020-03071-6'] 4137,33864584,An Evaluation of Strategies Used to Maximize Intervention Fidelity in a Randomized Controlled Trial of a Sexual Assault Resistance Program for University Women.,"In this paper, we describe and evaluate the strategies used to maximize intervention fidelity in a randomized controlled trial to examine the efficacy of a sexual assault resistance intervention. The EAAA program was based on the best available theory and evidence on how women can successfully resist sexual coercion from male acquaintances. Extensive protocols for hiring, training, and supervising facilitators were established a priori. Detailed intervention manuals were developed that clearly described program goals, learning objectives, core elements, troubleshooting tips, sections that must be delivered verbatim, adaptations that could be made if necessary, and the ideal and minimum dose. Program sessions were audio-recorded, and a subsample of recordings were scored for adherence to the manuals using detailed Intervention Fidelity Checklists (IFC) developed specifically for this research. The Gearing et al. (2011) Comprehensive Intervention Fidelity Guide (CFIG) was employed retrospectively to provide objectivity to our analysis and help identify what we did well and what we could have done better. The SARE (Sexual Assault Resistance Education) Trial received high scores (38 out of 44 (86%) from each of the first two authors on the CFIG, suggesting a high level of intervention fidelity. Although a potential for bias on the part of the two raters was an obvious limitation, as was our neglection to include measures of implementation receipt, which Gearing et al. (2011) recommended, our analysis underscores the utility in employing methods recommended to enhance intervention fidelity when developing and evaluating evidence-based interventions.",2021,"Trial received high scores (38 out of 44 (86%) from each of the first two authors on the CFIG, suggesting a high level of intervention fidelity.","['University Women', '2011']","['Comprehensive Intervention Fidelity Guide (CFIG', 'sexual assault resistance intervention', 'Sexual Assault Resistance Program']",['SARE\xa0(Sexual Assault Resistance Education'],"[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0237236', 'cui_str': 'Sexual assault'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0237236', 'cui_str': 'Sexual assault'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",,0.0237748,"Trial received high scores (38 out of 44 (86%) from each of the first two authors on the CFIG, suggesting a high level of intervention fidelity.","[{'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Hobden', 'Affiliation': 'Department of Psychology, University of Windsor, 401 Sunset Avenue, Windsor, ON, Canada. khobden@uwindsor.ca.'}, {'ForeName': 'Wilfreda E', 'Initials': 'WE', 'LastName': 'Thurston', 'Affiliation': 'Department of Community Health Sciences, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Gail L', 'Initials': 'GL', 'LastName': 'McVey', 'Affiliation': 'Toronto General Hospital, University Health Network, Toronto, Canada.'}, {'ForeName': 'Charlene Y', 'Initials': 'CY', 'LastName': 'Senn', 'Affiliation': 'Department of Psychology, University of Windsor, 401 Sunset Avenue, Windsor, ON, Canada.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-021-01239-2'] 4138,33864548,Community-Based Multi-Site Randomized Controlled Trial of Behavioral Activation for Patients with Depressive Disorders.,"Behavioral activation (BA) is a beneficial and relatively cost-effective treatment option for depression. This study utilized a pragmatic randomized controlled research design to investigate whether BA, as compared with treatment as usual (TAU), led to superior treatment effects, when delivered in community mental health settings by retrained community mental health professionals. Patients with depressive disorders (n = 64) were randomly assigned to a 10-session BA (n = 31) or TAU (n = 33) group. The depressive symptoms and behavioral engagement were assessed at the baseline, post-treatment, and a six-month follow-up. Results showed that, as compared to the TAU group, the BA group had: (1) a reduction in depression severity, as evidenced by large effect sizes and greater response rates, and (2) an increase in behavioral engagement. However, the post-treatment gains were not maintained at the six-month follow-up. The implications and limitations of the study are also discussed (KCT0004098, June 27, 2019, retrospectively registered).",2021,"Results showed that, as compared to the TAU group, the BA group had: (1) a reduction in depression severity, as evidenced by large effect sizes and greater response rates, and (2) an increase in behavioral engagement.","['Patients with Depressive Disorders', 'community mental health settings by retrained community mental health professionals', 'Patients with depressive disorders (n\u2009=\u200964']","['10-session BA', 'Behavioral activation (BA', 'Behavioral Activation', 'TAU']","['depressive symptoms and behavioral engagement', 'depression severity', 'behavioral engagement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0741922,"Results showed that, as compared to the TAU group, the BA group had: (1) a reduction in depression severity, as evidenced by large effect sizes and greater response rates, and (2) an increase in behavioral engagement.","[{'ForeName': 'Eunbyeol', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': 'Department of Psychology, Korea University, 145, Anam-ro, Seongbuk-gu, Seoul, 02841, Republic of Korea.'}, {'ForeName': 'Yeoul', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Psychology, Korea University, 145, Anam-ro, Seongbuk-gu, Seoul, 02841, Republic of Korea.'}, {'ForeName': 'Yun Ji', 'Initials': 'YJ', 'LastName': 'Cha', 'Affiliation': 'Department of Psychology, Korea University, 145, Anam-ro, Seongbuk-gu, Seoul, 02841, Republic of Korea.'}, {'ForeName': 'Ji-Hye', 'Initials': 'JH', 'LastName': 'Oh', 'Affiliation': ""Department of Psychiatry, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, 93, Jungbu-daero, Paldal-gu, Suwon-si, Gyeonggi-do, 16247, Republic of Korea.""}, {'ForeName': 'Na-Ri', 'Initials': 'NR', 'LastName': 'Hwang', 'Affiliation': ""Department of Psychiatry, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, 93, Jungbu-daero, Paldal-gu, Suwon-si, Gyeonggi-do, 16247, Republic of Korea.""}, {'ForeName': 'Ho-Jun', 'Initials': 'HJ', 'LastName': 'Seo', 'Affiliation': ""Department of Psychiatry, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, 93, Jungbu-daero, Paldal-gu, Suwon-si, Gyeonggi-do, 16247, Republic of Korea. healm@catholic.ac.kr.""}, {'ForeName': 'Kee-Hong', 'Initials': 'KH', 'LastName': 'Choi', 'Affiliation': 'Department of Psychology, Korea University, 145, Anam-ro, Seongbuk-gu, Seoul, 02841, Republic of Korea. kchoi1@korea.ac.kr.'}]",Community mental health journal,['10.1007/s10597-021-00828-3'] 4139,33864494,The effect of acute low-load resistance exercise with the addition of blood flow occlusion on muscle function in boys and men.,"PURPOSE In adults, low-load resistance training with blood flow occlusion (BFO) mimics strength increases that occur from high-load training, without the need to experience high mechanical stress. In view of child-adult differences in exercise responses, this study examined whether BFO during exercise elicits differential changes in maximal voluntary contraction (MVC) and electromyographical (EMG) activity in children and adults. METHODS Sixteen men (24.4 ± 2.5 years) and 14 boys (10.7 ± 2.0 years) performed low-load resistance exercise (25 repetitions at 35% MVC) of the wrist flexors with and without BFO. MVC wrist flexor force and EMG activity of the flexor carpi radialis (FCR) were obtained at the beginning and end of the exercise. RESULTS Both groups demonstrated a larger decrease in MVC force following BFO (- 18.6 ± 12.5%) than the control (without BFO) condition (- 6.2 ± 15.0%; p < 0.001). Whereas the men's EMG amplitude increased 16.3 ± 20.5% (p = 0.005) during BFO, the boys' EMG amplitude did not change over time or between conditions. In both groups, the mean power frequency (MPF) of the EMG signal decreased more during BFO (- 20.1 ± 9.6%; p < 0.001) than the control condition (- 5.6 ± 9.7%; p = 0.002). CONCLUSIONS Low-load exercise with BFO resulted in similar neuromuscular responses between boys and men, except for an observed increase in the EMG amplitude in men but not boys. While this result might suggest that men relied on a greater activation of higher-threshold motor units during BFO, it does not explain why there were similar decreases in MPF between groups. Therefore, it remains unclear whether the effectiveness of BFO training is similar for children and adults.",2021,"Whereas the men's EMG amplitude increased 16.3 ± 20.5% (p = 0.005) during BFO, the boys' EMG amplitude did not change over time or between conditions.","['Sixteen men (24.4\u2009±\u20092.5 years) and 14 boys (10.7\u2009±\u20092.0 years) performed', 'boys and men', 'children and adults']","['BFO training', 'low-load resistance exercise (25 repetitions at 35% MVC) of the wrist flexors with and without BFO', 'acute low-load resistance exercise', 'blood flow occlusion']","['EMG amplitude', 'mean power frequency (MPF) of the EMG signal', 'MVC wrist flexor force and EMG activity of the flexor carpi radialis (FCR', 'neuromuscular responses', 'maximal voluntary contraction (MVC) and electromyographical (EMG) activity', 'MVC force following BFO']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C5191365', 'cui_str': '10.7'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}]",,0.021102,"Whereas the men's EMG amplitude increased 16.3 ± 20.5% (p = 0.005) during BFO, the boys' EMG amplitude did not change over time or between conditions.","[{'ForeName': 'Alyssa M', 'Initials': 'AM', 'LastName': 'Bax', 'Affiliation': 'Department of Kinesiology, Faculty of Applied Health Sciences, Brock University, 1812 Sir Isaac Brock Way, St. Catharines, ON, L2S 3A1, Canada.'}, {'ForeName': 'Chimerem O', 'Initials': 'CO', 'LastName': 'Amiaka', 'Affiliation': 'Department of Kinesiology, Faculty of Applied Health Sciences, Brock University, 1812 Sir Isaac Brock Way, St. Catharines, ON, L2S 3A1, Canada.'}, {'ForeName': 'Bareket', 'Initials': 'B', 'LastName': 'Falk', 'Affiliation': 'Department of Kinesiology, Faculty of Applied Health Sciences, Brock University, 1812 Sir Isaac Brock Way, St. Catharines, ON, L2S 3A1, Canada.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Gabriel', 'Affiliation': 'Department of Kinesiology, Faculty of Applied Health Sciences, Brock University, 1812 Sir Isaac Brock Way, St. Catharines, ON, L2S 3A1, Canada.'}, {'ForeName': 'Craig D', 'Initials': 'CD', 'LastName': 'Tokuno', 'Affiliation': 'Department of Kinesiology, Faculty of Applied Health Sciences, Brock University, 1812 Sir Isaac Brock Way, St. Catharines, ON, L2S 3A1, Canada. ctokuno@brocku.ca.'}]",European journal of applied physiology,['10.1007/s00421-021-04687-4'] 4140,33864481,Effect of position therapy and oral devices on sleep parameters in patients with obstructive sleep apnea.,"PURPOSE The purpose of this study was to elucidate the effect of a neck-worn position therapy device (PTD) and oral appliance (OA) on sleep parameters in patients with obstructive sleep apnea (OSA). METHODS Patients with an apnea hypopnea index (AHI) of 5/h or more at baseline polysomnography were divided into a PTD group and an OA group randomly. All participants underwent a type 1 polysomnography for diagnosis and device-set outcome measurements. RESULTS The PTD decreased the AHI from a mean of 24.2/h to 16.7/h, and the OA decreased the AHI from 20.8/h to 10.3/h. Snoring duration decreased from 31.1% to 16.9% in the PTD group, and from 41.2% to 30.7% in the OA group. There were no significant differences in these decreases between the two groups. The PTD decreased sleep-time percentage in the supine position from a mean of 67.4% to 4.5%, despite five patients who were unable to avoid the supine position. There were no significant differences in improvement in sleep efficiency, percentage of stage wake, stage N1, stage N2, and stage REM, and overall arousal and respiratory arousal indices between the two groups. However, the spontaneous arousal index worsened in the OA responders but remained unchanged in the PTD responders. Percentage of stage N3 sleep (%N3) was improved in the PTD responders but not in the OA responders. There were significant differences in spontaneous arousal index and %N3 between the two groups. CONCLUSION PTDs are a potential treatment modality that does not disturb sleep in patients with OSA.",2021,"There were no significant differences in improvement in sleep efficiency, percentage of stage wake, stage N1, stage N2, and stage REM, and overall arousal and respiratory arousal indices between the two groups.","['patients with obstructive sleep apnea', 'patients with OSA', 'Patients with an apnea hypopnea index (AHI) of 5/h or more at baseline polysomnography', 'patients with obstructive sleep apnea (OSA']","['neck-worn position therapy device (PTD) and oral appliance (OA', 'position therapy and oral devices']","['Percentage of stage N3 sleep', 'sleep parameters', 'sleep-time percentage', 'sleep efficiency, percentage of stage wake, stage N1, stage N2, and stage REM, and overall arousal and respiratory arousal indices', 'Snoring duration', 'spontaneous arousal index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0234451', 'cui_str': 'Non-rapid eye movement sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0560134', 'cui_str': 'rem'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037384', 'cui_str': 'Snoring'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}]",5.0,0.0275135,"There were no significant differences in improvement in sleep efficiency, percentage of stage wake, stage N1, stage N2, and stage REM, and overall arousal and respiratory arousal indices between the two groups.","[{'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Suzuki', 'Affiliation': 'Department of Otorhinolaryngology, Teikyo University Chiba Medical Center, 3426-3 Anesaki, Ichihara, Chiba, 299-0111, Japan. suzukima@med.teikyo-u.ac.jp.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Funayama', 'Affiliation': 'Division of Sleep Medicine, Kaname Clinic, Tokyo, Japan.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Homma', 'Affiliation': 'Division of Sleep Medicine, Kaname Clinic, Tokyo, Japan.'}, {'ForeName': 'Kana', 'Initials': 'K', 'LastName': 'Shibasaki', 'Affiliation': 'Division of Sleep Medicine, Kaname Clinic, Tokyo, Japan.'}, {'ForeName': 'Taiji', 'Initials': 'T', 'LastName': 'Furukawa', 'Affiliation': 'Division of Sleep Medicine, Kaname Clinic, Tokyo, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Yosizawa', 'Affiliation': 'Division of Sleep Medicine, Kaname Clinic, Tokyo, Japan.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-021-06817-2'] 4141,33864466,Implementation of a workplace physical activity intervention in child care: process evaluation results from the Care2BWell trial.,"Care2BWell was designed to evaluate the efficacy of Healthy Lifestyles (HL), a worksite health promotion intervention to increase child care workers' physical activity. The purpose of this study was to use process evaluation to describe the implementation of HL and determine if different levels of implementation are associated with changes in workers' physical activity. Data were collected from 250 workers randomized to HL, a 6 month, multilevel intervention that included an educational workshop followed by three 8 week campaigns that included self-monitoring and feedback, raffle incentive, social support, and center director coaching. Process evaluation data collection included direct observation, self-reported evaluation surveys, website analytics and user test account data, tracking databases and semi-structured interviews. Implementation scores were calculated for each intervention component and compared at the center and individual levels. Nearly a third of workers never self-monitored and few (16%) met self-monitoring goals. Only 39% of centers engaged with the social support component as intended. Raffle and social support components were perceived as the least useful. Implementation varied widely by center (25%-76%) and individual workers (0%-94%). No within- or between-group differences for high compared to low implementation groups for change in physical activity were evident. Interview themes included limited sustainability, competing priorities, importance of social support, and desire for a more intensive, personalized intervention. Wide variation in implementation may explain limited effects on intervention outcomes. Future worksite interventions designed for child care workers can use these findings to optimize health promotion in this setting.",2021,"Interview themes included limited sustainability, competing priorities, importance of social support, and desire for a more intensive, personalized intervention.","['child care workers', 'child care']","['Healthy Lifestyles (HL), a worksite health promotion intervention', 'workplace physical activity intervention', 'multilevel intervention that included an educational workshop followed by three 8 week campaigns that included self-monitoring and feedback, raffle incentive, social support, and center director coaching']","['limited sustainability, competing priorities, importance of social support, and desire for a more intensive, personalized intervention', 'Implementation scores', 'physical activity', 'direct observation, self-reported evaluation surveys, website analytics and user test account data, tracking databases and semi-structured interviews']","[{'cui': 'C0008067', 'cui_str': 'Puericulture'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0439607', 'cui_str': 'Priorities'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]",250.0,0.00782329,"Interview themes included limited sustainability, competing priorities, importance of social support, and desire for a more intensive, personalized intervention.","[{'ForeName': 'Cody D', 'Initials': 'CD', 'LastName': 'Neshteruk', 'Affiliation': 'Department of Population Health Sciences, Duke University, Durham, NC, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Willis', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Falon', 'Initials': 'F', 'LastName': 'Smith', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Amber E', 'Initials': 'AE', 'LastName': 'Vaughn', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Anna H', 'Initials': 'AH', 'LastName': 'Grummon', 'Affiliation': 'Center for Population and Development Studies, Harvard University, Cambridge, MA, USA.'}, {'ForeName': 'Maihan B', 'Initials': 'MB', 'LastName': 'Vu', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Dianne S', 'Initials': 'DS', 'LastName': 'Ward', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Linnan', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Translational behavioral medicine,['10.1093/tbm/ibab034'] 4142,33864432,Lactobacillus casei alleviated the abnormal increase of cholestasis-related liver indices during tuberculosis treatment: a post hoc analysis of randomized controlled trial.,"SCOPE Probiotics are promising in mitigating drug-induced liver injury in animal experiments. However, the clinical evidence is absent. The objective is to investigate the effect of adjunctive Lactobacillus casei on tuberculosis-drug-induced liver injury. METHODS AND RESULTS A post hoc analysis was conducted for a previous randomized controlled trial. The trial was registered at the Chinese Clinical Trial Registry (No. ChiCTR-IOR-17013210). 429 patients were allocated to receive standard tuberculosis therapy alone (control group), or together with 1 × 10 10 colony-forming units (CFU) per day (low-dose group), or 2 × 10 10 CFU per day of L. casei (high-dose group) during tuberculosis treatment. The L. casei supplementation significantly reduced the incidence of the abnormal increase of cholestasis-related liver indices including alkaline phosphatase (p = 0.024) and bilirubin (p = 0.013). Plasma lipopolysaccharide (p = 0.02), intestinal permeability biomarkers including zonula occludens-1 (p = 0.001) and intestinal fatty acid binding protein (p = 0.002) were significantly reduced. The gut microbiota composition was dramatically altered with a reduction of Bacteroidetes (p<0.001) and a corresponding increase of Actinobacteria (p<0.001) and Firmicutes (p = 0.003). CONCLUSIONS L. casei supplementation is beneficial for suppressing abnormally elevated cholestasis-related liver indices during tuberculosis treatment, which may be related to its modification on blood lipopolysaccharide, intestinal barrier function and gut microbiota. This article is protected by copyright. All rights reserved.",2021,"Plasma lipopolysaccharide (p = 0.02), intestinal permeability biomarkers including zonula occludens-1 (p = 0.001) and intestinal fatty acid binding protein (p = 0.002) were significantly reduced.",['429 patients'],"['L. casei supplementation', 'standard tuberculosis therapy alone (control group', 'Probiotics', 'Lactobacillus casei', 'adjunctive Lactobacillus casei']","['incidence of the abnormal increase of cholestasis-related liver indices including alkaline phosphatase', 'intestinal fatty acid binding protein', 'gut microbiota composition', 'Plasma lipopolysaccharide', 'bilirubin', 'cholestasis-related liver indices', 'intestinal permeability biomarkers including zonula occludens-1']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0022940', 'cui_str': 'Lactobacillus casei'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0008370', 'cui_str': 'Cholestasis'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0163314', 'cui_str': 'Intestinal Fatty Acid-Binding Protein'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242358', 'cui_str': 'Tight junction'}]",429.0,0.413483,"Plasma lipopolysaccharide (p = 0.02), intestinal permeability biomarkers including zonula occludens-1 (p = 0.001) and intestinal fatty acid binding protein (p = 0.002) were significantly reduced.","[{'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Xiong', 'Affiliation': 'Institute of Nutrition and Health, School of Public Health, Qingdao University, Qingdao, Shandong, 266021, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': 'Institute of Nutrition and Health, School of Public Health, Qingdao University, Qingdao, Shandong, 266021, China.'}, {'ForeName': 'Peiying', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': ""Linyi People's Hospital, Linyi, Shandong, 276000, China.""}, {'ForeName': 'Jinyu', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Institute of Nutrition and Health, School of Public Health, Qingdao University, Qingdao, Shandong, 266021, China.'}, {'ForeName': 'Shanliang', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': ""Linyi People's Hospital, Linyi, Shandong, 276000, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Institute of Nutrition and Health, School of Public Health, Qingdao University, Qingdao, Shandong, 266021, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Institute of Nutrition and Health, School of Public Health, Qingdao University, Qingdao, Shandong, 266021, China.'}, {'ForeName': 'Jiahong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Qingdao Central Hospital, Qingdao, Shandong, 266042, China.'}, {'ForeName': 'Aiguo', 'Initials': 'A', 'LastName': 'Ma', 'Affiliation': 'Institute of Nutrition and Health, School of Public Health, Qingdao University, Qingdao, Shandong, 266021, China.'}]",Molecular nutrition & food research,['10.1002/mnfr.202100108'] 4143,33864390,African American marital confiding relationships: A national survey and a test of an educational intervention.,"We present two related studies on confiding about relationships among African Americans. Study one examined how African Americans serve as confidants in their social networks for people having couple relationship concerns. Using a national survey of African American adults, this study documented the prevalence of confiding relationships, the kinds of problems brought to confidants, and which confidant behaviors are seen as helpful and not helpful. Study two was a randomized controlled trial of Marital First Responders-AA, a culturally adapted version of the Marital First Responders program. Results showed improved skills among African Americans participants who were already natural confidants, as well greater frequency of confiding interactions in their social networks. Enhancing the abilities of natural confidants may be particularly important in the African American community because of stresses on couple relationships and the relatively lower use of therapy services.",2021,"Study two was a randomized controlled trial of Marital First Responders-AA, a culturally adapted version of the Marital First Responders program.","['African American marital confiding relationships', 'African American adults', 'African Americans', 'African Americans participants']",['educational intervention'],[],"[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0246548,"Study two was a randomized controlled trial of Marital First Responders-AA, a culturally adapted version of the Marital First Responders program.","[{'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Yeager', 'Affiliation': 'University of Minnesota, St. Paul, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Doherty', 'Affiliation': 'University of Minnesota, St. Paul, USA.'}]",Journal of marital and family therapy,['10.1111/jmft.12506'] 4144,33864354,Effect of magnesium and vitamin B6 supplementation on mental health and quality of life in stressed healthy adults: Post-hoc analysis of a randomised controlled trial.,"Magnesium status and vitamin B6 intake have been linked to mental health and/or quality of life (QoL). In an 8-week Phase IV randomised controlled study in individuals with low magnesemia and severe/extremely severe stress but who were otherwise healthy, greater stress reduction was achieved with magnesium combined with vitamin B6 than with magnesium alone. Here, we present a previously unreported secondary analysis of the effect of magnesium, with and without vitamin B6, on depression, anxiety, and QoL. Adults with Depression Anxiety Stress Scales (DASS-42) stress subscale score >18 were randomised 1:1 to magnesium+vitamin B6 combination (Magne B6 ® ; daily dose 300mg and 30mg, respectively) or magnesium alone (Magnespasmyl ® ; daily dose 300mg). Outcomes included changes from baseline in DASS-42 depression and anxiety scores, and QoL (Short Form-36 Health Survey). DASS-42 anxiety and depression scores significantly improved from baseline to week 8 with both treatments, particularly during the first 4 weeks. Improvement in QoL continued over 8 weeks. Participants' perceived capacity for physical activity in daily life showed greater improvement with magnesium+vitamin B6 than magnesium alone (Week 4). In conclusion, magnesium supplementation, with or without vitamin B6, could provide a meaningful clinical benefit in daily life for individuals with stress and low magnesemia. This article is protected by copyright. All rights reserved.",2021,"DASS-42 anxiety and depression scores significantly improved from baseline to week 8 with both treatments, particularly during the first 4 weeks.","['Adults with Depression Anxiety Stress Scales (DASS-42) stress subscale score >18', 'individuals with low magnesemia and severe/extremely severe stress but who were otherwise healthy, greater stress reduction was achieved with', 'stressed healthy adults', 'individuals with stress and low magnesemia']","['magnesium, with and without vitamin B6', 'magnesium supplementation, with or without vitamin B6', 'magnesium and vitamin B6 supplementation', 'magnesium+vitamin B6 combination (Magne B6 ® ; daily dose 300mg and 30mg, respectively) or magnesium alone (Magnespasmyl ® ', 'magnesium combined with vitamin B6 than with magnesium alone', 'Magnesium status and vitamin B6 intake']","['DASS-42 depression and anxiety scores, and QoL (Short Form-36 Health Survey', 'mental health and quality of life', 'DASS-42 anxiety and depression scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0034272', 'cui_str': 'pyridoxine'}, {'cui': 'C1096534', 'cui_str': 'Magnesium supplement therapy'}, {'cui': 'C4524021', 'cui_str': 'Vitamin B6 supplementation'}, {'cui': 'C3252126', 'cui_str': 'Magne B6'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0564418', 'cui_str': 'Vitamin B6 intake'}]","[{'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",,0.304968,"DASS-42 anxiety and depression scores significantly improved from baseline to week 8 with both treatments, particularly during the first 4 weeks.","[{'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Noah', 'Affiliation': 'Global Medical Nutritionals, Consumer Healthcare, Sanofi-Aventis, Paris, France.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Dye', 'Affiliation': 'Nutrition and Behaviour Group, School of Psychology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Béatrice Bois', 'Initials': 'BB', 'LastName': 'De Fer', 'Affiliation': 'Statistics, Consumer Healthcare, Sanofi-Aventis, Paris, France.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Mazur', 'Affiliation': 'Université Clermont Auvergne, INRAE, UNH, Unité de Nutrition Humaine, Clermont-Ferrand, France.'}, {'ForeName': 'Gisèle', 'Initials': 'G', 'LastName': 'Pickering', 'Affiliation': 'Clinical Pharmacology Centre, INSERM CIC 1405, University Hospital Clermont-Ferrand, France.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Pouteau', 'Affiliation': 'Global Medical Nutritionals, Consumer Healthcare, Sanofi-Aventis, Paris, France.'}]",Stress and health : journal of the International Society for the Investigation of Stress,['10.1002/smi.3051'] 4145,33864342,Minimising the risk of early symptomatic parastomal herniation.,"No matter how meticulously a stoma trephine is constructed, the surgeon has in fact created an iatrogenic hernia. Over the last decade much effort has been devoted to looking at different trephines, including the use of prophylactic mesh placed at the primary operation. Two new trials have reported important results. The Stoma-Const randomised trial recently reported the use of differing surgical techniques to reduce stoma related complications.",2021,"Over the last decade much effort has been devoted to looking at different trephines, including the use of prophylactic mesh placed at the primary operation.",[],[],[],[],[],[],,0.186397,"Over the last decade much effort has been devoted to looking at different trephines, including the use of prophylactic mesh placed at the primary operation.","[{'ForeName': 'Geraint', 'Initials': 'G', 'LastName': 'Herbert', 'Affiliation': 'Department of Colorectal Surgery, Royal Gwent Hospital, Newport, South Wales, NP20 2UB, UK.'}, {'ForeName': 'Gethin L', 'Initials': 'GL', 'LastName': 'Williams', 'Affiliation': 'Department of Colorectal Surgery, Royal Gwent Hospital, Newport, South Wales, NP20 2UB, UK.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Stephenson', 'Affiliation': 'Department of Colorectal Surgery, Royal Gwent Hospital, Newport, South Wales, NP20 2UB, UK.'}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.15679'] 4146,33864337,Efficacy of various laser devices on lithotripsy in retrograde intrarenal surgery used to treat 1-2 cm kidney stones: A prospective randomized study.,"AIMS To compare the efficacy of different laser devices and power ranges on lithotripsy in retrograde intrarenal surgery (RIRS) for 1-2 cm kidney stones. METHODS A total of 223 participants undergoing RIRS for 1-2 cm kidney stones at our clinic between January 2015 and January 2017 were recruited for this prospective study (NCT02451319). Two hundred and four participants included in our study were randomly allocated into either ≤20 watt (W) with 20W laser device (group 1) or ≤20 watt (W) with 30W laser device (group 2) or >20W with 30W laser device (group 3). RESULTS There was no significant difference between the groups in terms of demographic and stone characteristics. Operation and fluoroscopy times were significantly longer (p=0.003 and p<0.001, respectively) and stone-free rate (SFR) was significantly lower in group 1 (p=0.002). Complications were similar in all 3 groups (p=0.512). However, postoperative pain scores were significantly higher in group 1 (p<0.001). The multivariate analysis revealed that stone size (95%CI:0.654-0.878, OR=0.758, p<0.001), ureteral access sheath use (95%CI:1.003-20.725, OR=4.560, p=0.049), and lithotripsy with 30W laser device (95%CI:1.304-11.632, OR=3.895, p=0.015; 95%CI:1.738-17.281, OR=5.480, p=0.004, groups 2 and 3, respectively) were independent factors predicting SFR for RIRS used in 1-2 cm kidney stones. CONCLUSION The 30W laser device used in RIRS for 1-2 cm kidney stones had shorter operation times, higher SFRs, and lower postoperative pain scores compared to the 20W device. The 30W laser device is safe and more efficient in RIRS for treatment of 1-2 cm kidney stones.",2021,"Operation and fluoroscopy times were significantly longer (p=0.003 and p<0.001, respectively) and stone-free rate (SFR) was significantly lower in group 1 (p=0.002).","['retrograde intrarenal surgery used to treat 1-2 cm kidney stones', '223 participants undergoing RIRS for 1-2 cm kidney stones at our clinic between January 2015 and January 2017', 'Two hundred and four participants included in our study']","['laser devices and power ranges on lithotripsy in retrograde intrarenal surgery (RIRS', '20W laser device (group 1) or ≤20 watt (W) with 30W laser device (group 2) or >20W with 30W laser device', 'various laser devices']","['stone size', 'ureteral access sheath use', 'Complications', 'shorter operation times, higher SFRs, and lower postoperative pain scores', 'stone-free rate (SFR', 'Operation and fluoroscopy times', 'postoperative pain scores', 'demographic and stone characteristics']","[{'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0439261', 'cui_str': 'watt'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0449454', 'cui_str': 'Stone size'}, {'cui': 'C1522613', 'cui_str': 'Ureteral route'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",223.0,0.0567834,"Operation and fluoroscopy times were significantly longer (p=0.003 and p<0.001, respectively) and stone-free rate (SFR) was significantly lower in group 1 (p=0.002).","[{'ForeName': 'Nihat', 'Initials': 'N', 'LastName': 'Karakoyunlu', 'Affiliation': 'Department of Urology, Health Sciences University, Diskapi Yildirim Beyazit Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Mehmet Çağlar', 'Initials': 'MÇ', 'LastName': 'Çakıcı', 'Affiliation': 'Department of Urology, Istanbul Medeniyet University Goztepe Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Sercan', 'Initials': 'S', 'LastName': 'Sarı', 'Affiliation': 'Department of Urology, Bozok University Faculty of Medicine Hospital, Yozgat, Turkey.'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Hepşen', 'Affiliation': 'Department of Urology, Yildirim Beyazit University Yenimahalle Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Muslim', 'Initials': 'M', 'LastName': 'Bikirov', 'Affiliation': 'Department of Urology, Health Sciences University, Diskapi Yildirim Beyazit Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Erdem', 'Initials': 'E', 'LastName': 'Kısa', 'Affiliation': 'Department of Urology, Health Sciences University, Izmir Tepecik Training and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Serra', 'Initials': 'S', 'LastName': 'Özbal', 'Affiliation': 'Department of Radiology, Health Sciences University, Diskapi Yildirim Beyazit Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Hakkı Uğur', 'Initials': 'HU', 'LastName': 'Özok', 'Affiliation': 'Department of Urology, Karabuk University Faculty of Medicine Hospital, Karabük, Turkey.'}, {'ForeName': 'Hamit', 'Initials': 'H', 'LastName': 'Ersoy', 'Affiliation': 'Department of Urology, Health Sciences University, Diskapi Yildirim Beyazit Training and Research Hospital, Ankara, Turkey.'}]",International journal of clinical practice,['10.1111/ijcp.14216'] 4147,33864331,Three Learning Modalities' Impact on Clinical Judgment and Perceptions in Newly Graduated Registered Nurses: A Quasi-experimental Study.,"Newly graduated registered nurses face numerous challenges stemming from high patient workload, complicated interpersonal relationships, and a lack of nursing competence, which can lead to transitional shocks. Clinical judgment and confidence are well-known keys to successful role transitions for these nurses. Simulation training is proposed as a new modality for enhancing comprehensive clinical competence of nurses, but current evidences on the impact of different simulations on nurses' clinical judgment and confidence are still limited or inconsistent. This study compared the impact of three types of learning modality on newly graduated registered nurses' clinical judgment, perceptions of self-confidence, and evaluations of the design features of the learning modalities. A quasi-experimental design was used. Fifty-nine participants were randomly assigned to three groups: (1) high-fidelity simulation, (2) virtual simulation, and (3) case study. Scales were used after the simulation. The virtual simulation group showed a higher level of clinical judgment. The high-fidelity simulation group felt more confident than the virtual simulation and case study groups. Both the high-fidelity simulation group and virtual simulation group reported higher scores in the domain of fidelity.",2021,The virtual simulation group showed a higher level of clinical judgment.,"['Newly Graduated Registered Nurses', 'Fifty-nine participants']","['Simulation training', 'learning modality']",['higher level of clinical judgment'],"[{'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse'}, {'cui': 'C3830128', 'cui_str': '59'}]","[{'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}]",59.0,0.101417,The virtual simulation group showed a higher level of clinical judgment.,"[{'ForeName': 'Yiqing', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Wuhan University School of Health Sciences, Wuhan, China.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Geng', 'Affiliation': 'Wuhan University School of Health Sciences, Wuhan, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Wuhan University School of Health Sciences, Wuhan, China.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Zhong Nan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Zhijie', 'Initials': 'Z', 'LastName': 'Zou', 'Affiliation': 'Wuhan University School of Health Sciences, Wuhan, China.'}, {'ForeName': 'Jinbing', 'Initials': 'J', 'LastName': 'Bai', 'Affiliation': 'Emory University Nell Hodgson Woodruff School of Nursing, Atlanta, GA, USA.'}]",Nursing & health sciences,['10.1111/nhs.12842'] 4148,33864234,Relationships Between Dietary Intake and Weight-Related Experiential Avoidance Following Behavioral Weight-Loss Treatment.,"BACKGROUND Interventions targeting weight-related experiential avoidance (EA) and disinhibited eating (DE) may also improve diet quality. Participants with overweight/obesity and DE who recently completed a behavioral weight-loss program were randomized to receive acceptance and commitment therapy or continued behavioral weight-loss treatment. In this secondary analysis, we explored (1) change in diet quality from baseline to 6-month follow-up (FU) and (2) whether weight-related EA at baseline and (3) change in weight-related EA during treatment were related to change in diet quality from baseline to FU. METHOD Veterans (N = 68) completed food frequency questionnaires at baseline and FU, which were used to generate diet quality scores on the healthy eating index-15 (HEI-15). Weight-related EA was assessed using the Acceptance and Action Questionnaire for Weight-Related Difficulties-Revised (AAQW-R) at baseline, post-treatment, and FU. Aims were examined with mixed ANOVA analyses. RESULTS Across both treatment groups, HEI-15 scores declined from baseline to FU. Women's HEI-15 decreased by about 5 times that of men. Baseline AAWQ-R was negatively associated with change in HEI-15. Neither AAWQ-R at post-treatment nor change in AAQW-R from baseline to post-treatment was significantly associated with change in HEI-15 at FU. CONCLUSIONS Greater weight-related EA at baseline was associated with lower diet quality at FU, but change in weight-related EA during treatment did not predict change in diet quality at FU. Interventions targeting DE and weight-loss may require specific components to improve and sustain healthy dietary intake in Veterans with obesity and DE.",2021,"Neither AAWQ-R at post-treatment nor change in AAQW-R from baseline to post-treatment was significantly associated with change in HEI-15 at FU. ","['Veterans (N\u2009=\u200968) completed', 'Veterans with obesity and DE', 'Participants with overweight/obesity and DE who recently completed a behavioral weight-loss program']","['food frequency questionnaires at baseline and FU', 'Interventions targeting weight-related experiential avoidance (EA) and disinhibited eating (DE', 'acceptance and commitment therapy or continued behavioral weight-loss treatment']","['diet quality', 'AAQW-R', 'Greater weight-related EA', 'Acceptance and Action Questionnaire for Weight-Related Difficulties-Revised (AAQW-R', 'Baseline AAWQ-R', 'HEI-15 scores']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1272247', 'cui_str': 'Target weight'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0333907,"Neither AAWQ-R at post-treatment nor change in AAQW-R from baseline to post-treatment was significantly associated with change in HEI-15 at FU. ","[{'ForeName': 'Jennalee S', 'Initials': 'JS', 'LastName': 'Wooldridge', 'Affiliation': 'VA San Diego Healthcare System, San Diego, USA.'}, {'ForeName': 'Brian H', 'Initials': 'BH', 'LastName': 'Blanco', 'Affiliation': 'VA San Diego Healthcare System, San Diego, USA.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Dochat', 'Affiliation': 'San Diego Joint Doctoral Program in Clinical Psychology, San Diego State University, University of California, San Diego, USA.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Herbert', 'Affiliation': 'VA San Diego Healthcare System, San Diego, USA.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Godfrey', 'Affiliation': 'Center for Work Life Wellbeing, Christiana Care, Newark, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Salamat', 'Affiliation': 'VA San Diego Healthcare System, San Diego, USA.'}, {'ForeName': 'Niloofar', 'Initials': 'N', 'LastName': 'Afari', 'Affiliation': 'VA San Diego Healthcare System, San Diego, USA. nafari@ucsd.edu.'}]",International journal of behavioral medicine,['10.1007/s12529-021-09990-0'] 4149,33864229,Effects of Gocovri (Amantadine) Extended Release Capsules on Non-Motor Symptoms in Patients with Parkinson's Disease and Dyskinesia.,"INTRODUCTION Gocovri (amantadine) extended release capsules are approved for treatment of dyskinesia and as a levodopa adjunct for OFF episodes in patients with Parkinson's disease (PD). We report treatment-related effects on non-motor symptoms (NMS) assessed as secondary outcomes in two trials using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I. METHODS EASE LID and EASE LID 3 enrolled levodopa-treated patients with PD and ≥ 1 h/day ON time with troublesome dyskinesia. Patients were randomized to Gocovri (274 mg) or placebo taken daily at bedtime. Treatment differences from baseline to week 12 in MDS-UPDRS Part I were evaluated for the pooled population (N = 196) from both trials. Correlation analyses of NMS (MDS-UPDRS Part I) with dyskinesia using Unified Dyskinesia Rating Scale (UDysRS) scores were performed. RESULTS For changes in the MDS-UPDRS Part I items, the treatment difference favored Gocovri in daytime sleepiness (P = 0.006) and depression (P = 0.049) scores, but favored placebo in cognitive impairment (P = 0.038), and  hallucinations and psychosis (P < 0.001) scores. The treatment difference for the changes in total Part I score was -0.8, favoring Gocovri (P = 0.22). At baseline, MDS-UPDRS Part I modestly correlated with UDysRS score (r +0.25, P < 0.001), and improvement in NMS correlated with improvement in dyskinesia at week 12 for Gocovri (r +0.39, P < 0.001) but not placebo (r +0.12, P = 0.29). The most commonly reported adverse events for Gocovri were hallucination (21%); dizziness, dry mouth, and peripheral edema (16% each); and constipation, falls, and orthostatic hypotension (13% each). CONCLUSION This post hoc analysis shows potential benefit with Gocovri treatment for the NMS of daytime sleepiness and depression in dyskinetic PD patients. Overall, improvement in NMS scores correlated with improvement in dyskinesia. TRIAL REGISTRATION ClinicalTrials.gov identifiers: NCT02136914 and NCT02274766.",2021,"The treatment difference for the changes in total Part I score was -0.8, favoring Gocovri (P = 0.22).","[""Patients with Parkinson's Disease and Dyskinesia"", 'EASE LID and EASE LID 3 enrolled levodopa-treated patients with PD and\u2009≥', 'dyskinetic PD patients', ""patients with Parkinson's disease (PD""]","['Gocovri', 'placebo', 'Gocovri (Amantadine', 'Gocovri (amantadine']","['depression', 'total Part I score', 'dyskinesia', 'hallucinations and psychosis', 'UDysRS score', 'Gocovri in daytime sleepiness', 'dizziness, dry mouth, and peripheral edema', ""Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS"", 'constipation, falls, and orthostatic hypotension', 'NMS (MDS-UPDRS Part I) with dyskinesia using Unified Dyskinesia Rating Scale (UDysRS) scores', 'NMS scores', 'cognitive impairment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439842', 'cui_str': 'Dyskinetic'}]","[{'cui': 'C4522700', 'cui_str': 'Gocovri'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002403', 'cui_str': 'Amantadine'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0018524', 'cui_str': 'Hallucinations'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4522700', 'cui_str': 'Gocovri'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0085649', 'cui_str': 'Peripheral edema'}, {'cui': 'C0026650', 'cui_str': 'Movement disorder'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0020651', 'cui_str': 'Orthostatic hypotension'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]",3.0,0.200962,"The treatment difference for the changes in total Part I score was -0.8, favoring Gocovri (P = 0.22).","[{'ForeName': 'Shyamal H', 'Initials': 'SH', 'LastName': 'Mehta', 'Affiliation': 'Department of Neurology, Mayo Clinic-Scottsdale, 13400 East Shea Blvd, Scottsdale, AZ, 85254, USA. mehta.shyamal@mayo.edu.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Pahwa', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Tanner', 'Affiliation': 'Department of Neurology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Hauser', 'Affiliation': ""USF Parkinson's Disease and Movement Disorders Center Parkinson Foundation Center of Excellence, University of South Florida, Tampa, FL, USA.""}, {'ForeName': 'Reed', 'Initials': 'R', 'LastName': 'Johnson', 'Affiliation': 'Adamas Pharmaceuticals, Inc., Emeryville, CA, USA.'}]",Neurology and therapy,['10.1007/s40120-021-00246-3'] 4150,33864164,The development and initial validation of the Breast Cancer Recurrence instrument (BreastCaRe)-a patient-reported outcome measure for detecting symptoms of recurrence after breast cancer.,"PURPOSE Patient-reported outomes (PRO) may facilitate prompt treatment. We describe the development and psychometric properties of the first instrument to monitor for symptoms of breast cancer (BC) recurrence. METHODS This study is nested in the MyHealth randomized trial of nurse-led follow-up based on electronically-collected PROs. We constructed items assessing symptoms of potential recurrence through expert interviews with six BC specialists in Denmark. Semi-structured cognitive interviews were carried out with a patient panel to assess acceptability and comprehensibility. Items were subsequently tested in a population of 1170 women 1-10 years after completing BC treatment. We carried out multiple-groups confirmatory factor analysis (CFA) and Rasch analysis to test dimensionality, local dependence (LD) and differential item functioning (DIF) according to sociodemographic and treatment-related factors. Clinical data was obtained from the Danish Breast Cancer Group registry. RESULTS Twenty-two items were generated for the Breast Cancer Recurrence instrument (BreastCaRe). Cognitive testing resulted in clearer items. Seven subscales based on general, bone, liver, lung, brain, locoregional and contralateral recurrence symptoms were proposed. Both CFA and Rasch models confirmed the factor structure. No DIF was identified. Five item pairs showed LD but all items were retained to avoid loss of clinical information. Rasch models taking LD into account were used to generate a standardized scoring table for each subscale. CONCLUSIONS The BreastCaRe has good content and structural validity, patient acceptability and measurement invariance. We are preparing to examine the predictive validity of this new instrument.",2021,No DIF was identified.,['1170 women 1-10\xa0years after completing BC treatment'],[],"['general, bone, liver, lung, brain, locoregional and contralateral recurrence symptoms', 'Breast Cancer Recurrence instrument (BreastCaRe']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],"[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}]",,0.119716,No DIF was identified.,"[{'ForeName': 'Beverley Lim', 'Initials': 'BL', 'LastName': 'Høeg', 'Affiliation': 'Psychological Aspects of Cancer, Danish Cancer Society Research Center, Strandboulevarden 49, 2100, Copenhagen, Denmark. bevlim@cancer.dk.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Saltbæk', 'Affiliation': 'Survivorship and Inequality in Cancer, Danish Cancer Society Research Center, Copenhagen, Denmark.'}, {'ForeName': 'Karl Bang', 'Initials': 'KB', 'LastName': 'Christensen', 'Affiliation': 'Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Randi Valbjørn', 'Initials': 'RV', 'LastName': 'Karlsen', 'Affiliation': 'Psychological Aspects of Cancer, Danish Cancer Society Research Center, Strandboulevarden 49, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Christoffer', 'Initials': 'C', 'LastName': 'Johansen', 'Affiliation': 'Psychological Aspects of Cancer, Danish Cancer Society Research Center, Strandboulevarden 49, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Susanne Oksbjerg', 'Initials': 'SO', 'LastName': 'Dalton', 'Affiliation': 'Survivorship and Inequality in Cancer, Danish Cancer Society Research Center, Copenhagen, Denmark.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Bennett', 'Affiliation': 'Cancer Outcomes Research Program, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, USA.'}, {'ForeName': 'Pernille Envold', 'Initials': 'PE', 'LastName': 'Bidstrup', 'Affiliation': 'Psychological Aspects of Cancer, Danish Cancer Society Research Center, Strandboulevarden 49, 2100, Copenhagen, Denmark.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-021-02841-1'] 4151,33864153,Role of asymptomatic bacteriuria on early periprosthetic joint infection after hip hemiarthroplasty. BARIFER randomized clinical trial.,"PURPOSE To evaluate preoperative asymptomatic bacteriuria (ASB) treatment to reduce early-periprosthetic joint infections (early-PJIs) after hip hemiarthroplasty (HHA) for fracture. METHODS Open-label, multicenter RCT comparing fosfomycin-trometamol versus no intervention with a parallel follow-up cohort without ASB. PRIMARY OUTCOME early-PJI after HHA. RESULTS Five hundred ninety-four patients enrolled (mean age 84.3); 152(25%) with ASB (77 treated with fosfomycin-trometamol/75 controls) and 442(75%) without. Despite the study closed without the intended sample size, ASB was not predictive of early-PJI (OR: 1.06 [95%CI: 0.33-3.38]), and its treatment did not modify early-PJI incidence (OR: 1.03 [95%CI: 0.15-7.10]). CONCLUSIONS Neither preoperative ASB nor its treatment appears to be risk factors of early-PJI after HHA. ClinicalTrials.gov Identifier: Eudra CT 2016-001108-47.",2021,Neither preoperative ASB nor its treatment appears to be risk factors of early-PJI after HHA.,"['asymptomatic bacteriuria on early periprosthetic joint infection after hip hemiarthroplasty', 'early-periprosthetic joint infections (early-PJIs) after hip hemiarthroplasty (HHA) for fracture', 'Five hundred ninety-four patients enrolled (mean age 84.3); 152(25%) with ASB (77 treated with fosfomycin-trometamol/75 controls) and 442(75%) without']",['fosfomycin-trometamol'],[],"[{'cui': 'C0262380', 'cui_str': 'Asymptomatic bacteriuria'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0157749', 'cui_str': 'Arthropathy associated with infection'}, {'cui': 'C1112760', 'cui_str': 'Hip hemiarthroplasty'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0016610', 'cui_str': 'Fosfomycin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0016610', 'cui_str': 'Fosfomycin'}, {'cui': 'C0041175', 'cui_str': 'Tromethamine'}]",[],594.0,0.124226,Neither preoperative ASB nor its treatment appears to be risk factors of early-PJI after HHA.,"[{'ForeName': 'Dolors', 'Initials': 'D', 'LastName': 'Rodríguez-Pardo', 'Affiliation': ""Infectious Diseases Department, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Pg. Vall d'Hebron 119-129, 08035, Barcelona, Spain. dolorodriguez@vhebron.net.""}, {'ForeName': 'María Dolores', 'Initials': 'MD', 'LastName': 'Del Toro', 'Affiliation': 'Spanish Network for Research in Infectious Diseases (REIPI RD16/0016/0003), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Guío-Carrión', 'Affiliation': 'Spanish Network for Research in Infectious Diseases (REIPI RD16/0016/0003), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Escudero-Sánchez', 'Affiliation': 'Study Group on Osteoarticular Infections of the Spanish Society of Clinical Microbiology and Infectious Diseases (GEIO-SEIMC), Madrid, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Fernández-Sampedro', 'Affiliation': 'Spanish Network for Research in Infectious Diseases (REIPI RD16/0016/0003), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'García-Viejo', 'Affiliation': 'Study Group on Osteoarticular Infections of the Spanish Society of Clinical Microbiology and Infectious Diseases (GEIO-SEIMC), Madrid, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Velasco-Arribas', 'Affiliation': 'Study Group on Osteoarticular Infections of the Spanish Society of Clinical Microbiology and Infectious Diseases (GEIO-SEIMC), Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Soldevila-Boixader', 'Affiliation': 'Study Group on Osteoarticular Infections of the Spanish Society of Clinical Microbiology and Infectious Diseases (GEIO-SEIMC), Madrid, Spain.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Femenias', 'Affiliation': 'Orthopedic Surgery Department, Hospital Universitario Son Espases, Palma de Mallorca, Spain.'}, {'ForeName': 'José Antonio', 'Initials': 'JA', 'LastName': 'Iribarren', 'Affiliation': 'Study Group on Osteoarticular Infections of the Spanish Society of Clinical Microbiology and Infectious Diseases (GEIO-SEIMC), Madrid, Spain.'}, {'ForeName': 'María Del Carmen', 'Initials': 'MDC', 'LastName': 'Pulido-Garcia', 'Affiliation': 'Orthopedic Surgery Department, Hospital Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'María Dolores', 'Initials': 'MD', 'LastName': 'Navarro', 'Affiliation': 'Spanish Network for Research in Infectious Diseases (REIPI RD16/0016/0003), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Mayli', 'Initials': 'M', 'LastName': 'Lung', 'Affiliation': 'Spanish Network for Research in Infectious Diseases (REIPI RD16/0016/0003), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Pablo S', 'Initials': 'PS', 'LastName': 'Corona', 'Affiliation': 'Spanish Network for Research in Infectious Diseases (REIPI RD16/0016/0003), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Benito', 'Initials': 'B', 'LastName': 'Almirante', 'Affiliation': ""Infectious Diseases Department, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Pg. Vall d'Hebron 119-129, 08035, Barcelona, Spain.""}, {'ForeName': 'Carles', 'Initials': 'C', 'LastName': 'Pigrau', 'Affiliation': ""Infectious Diseases Department, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Pg. Vall d'Hebron 119-129, 08035, Barcelona, Spain.""}]",European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology,['10.1007/s10096-021-04241-2'] 4152,33847344,Maternal Cod Intake during Pregnancy and Infant Development in the First Year of Life: Secondary Analyses from a Randomized Controlled Trial.,"BACKGROUND Maternal seafood intake during pregnancy is associated with child neurodevelopment. No randomized controlled trials (RCTs) have examined the effect of maternal lean fish consumption during pregnancy on child neurodevelopment. OBJECTIVES The objective of the study was to examine the effect of increased maternal cod intake during pregnancy on infant general and socio-emotional development in the first year of life, and whether any effects observed were mediated by maternal iodine status. METHODS In an RCT, 133 pregnant women (≤19 weeks of gestation) were randomly assigned to receive 200 g cod fillet twice weekly (intervention) or to continue with their habitual diet (control) for 16 wk. The mothers completed the developmental screening questionnaires Ages and Stages Questionnaire, 2nd edition (ASQ-2) and Ages and Stages Questionnaire: Social-Emotional (ASQ:SE) when the infants were 3, 6, and 11 mo old. We compared scores between groups using linear mixed-effects models and examined whether iodine status postintervention mediated the effect on child development. RESULTS We found no difference between infants in the intervention and control groups on total ASQ-2 scores (P = 0.633), but a difference on the ASQ:SE scores in favor of the intervention group (20.9 and 20.5 in the intervention group and 26.1 and 26.8 in the control group for 3 and 6 mo, respectively; P = 0.020). There was no difference in change of the scores between the groups over time (P = 0.946). The effect of group on the total ASQ:SE scores was not mediated via maternal urinary iodine concentration postintervention (β = -1.03, SE = 0.68, P = 0.126). CONCLUSIONS Our results provide no evidence for an effect of increased cod intake during pregnancy on general child development in the first year of life, but there was a positive effect on socio-emotional problems. More studies are needed to define the role of fish consumption during pregnancy and the effects on child neurodevelopment.This trial was registered at clinicaltrials.gov as NCT02610959.",2021,"We found no difference between infants in the intervention and control groups on total ASQ-2 scores (P = 0.633), but a difference on the ASQ:SE scores in favor of the intervention group (20.9 and 20.5 in the intervention group and 26.1 and 26.8 in the control group for 3 and 6 mo, respectively; P = 0.020).","['First Year of Life', '133 pregnant women (≤19 weeks of gestation']",['200 g cod fillet twice weekly (intervention) or to continue with their habitual diet (control'],"['total ASQ-2 scores', 'Maternal Cod Intake', 'ASQ:SE scores', 'total ASQ:SE scores', 'developmental screening questionnaires Ages and Stages Questionnaire, 2nd edition (ASQ-2) and Ages and Stages Questionnaire: Social-Emotional (ASQ:SE', 'maternal cod intake']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0184934', 'cui_str': 'Filleting'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",133.0,0.0932017,"We found no difference between infants in the intervention and control groups on total ASQ-2 scores (P = 0.633), but a difference on the ASQ:SE scores in favor of the intervention group (20.9 and 20.5 in the intervention group and 26.1 and 26.8 in the control group for 3 and 6 mo, respectively; P = 0.020).","[{'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Kvestad', 'Affiliation': 'Regional Center for Child and Youth Mental Health and Child Welfare, NORCE Norwegian Research Centre, Bergen, Norway.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Hysing', 'Affiliation': 'Department of Psychosocial Science, Faculty of Psychology, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Kjellevold', 'Affiliation': 'Department of Seafood, Nutrition and Environmental State, Institute of Marine Research, Bergen, Norway.'}, {'ForeName': 'Synnøve', 'Initials': 'S', 'LastName': 'Næss', 'Affiliation': 'Department of Seafood, Nutrition and Environmental State, Institute of Marine Research, Bergen, Norway.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Dahl', 'Affiliation': 'Department of Seafood, Nutrition and Environmental State, Institute of Marine Research, Bergen, Norway.'}, {'ForeName': 'Maria W', 'Initials': 'MW', 'LastName': 'Markhus', 'Affiliation': 'Department of Seafood, Nutrition and Environmental State, Institute of Marine Research, Bergen, Norway.'}]",The Journal of nutrition,['10.1093/jn/nxab083'] 4153,33863854,Effects of Resistance Training With Machines and Elastic Tubes on Functional Capacity and Muscle Strength in Community-Living Older Women: A Randomized Clinical Trial.,"The aim of the present study is to compare the effects of 12 weeks of resistance training with machines and elastic tubes on functional capacity and muscular strength in older women aged 60 years or over. The participants were randomized into two groups: a machine group (n = 23) and an elastic group (n = 20). They performed 12 weeks of progressive resistance training, twice a week, with similar exercises. Outcomes were assessed at three time points: baseline, postintervention, and 8 weeks after the end of the training. A significant intragroup effect was demonstrated for both groups at postintervention on functional tests and muscle strength. For the functional reach test and elbow flexion strength (180°/s), only the machine group demonstrated significant intragroup differences. No differences were observed between groups for any outcome. At the 8-week follow-up, functional capacity outcome values were maintained. The muscle strength outcome values decreased to baseline scores, without differences between groups.",2021,"For the functional reach test and elbow flexion strength (180°/s), only the machine group demonstrated significant intragroup differences.","['older women aged 60 years or over', 'Community-Living Older Women']","['resistance training with machines and elastic tubes', 'Resistance Training With Machines and Elastic Tubes', 'progressive resistance training', 'machine group']","['functional capacity and muscular strength', 'functional reach test and elbow flexion strength', 'functional tests and muscle strength', 'Functional Capacity and Muscle Strength']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0557143', 'cui_str': 'Lives in a community'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C1998271', 'cui_str': 'Functional reach test'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",,0.0463068,"For the functional reach test and elbow flexion strength (180°/s), only the machine group demonstrated significant intragroup differences.","[{'ForeName': 'Marisete P', 'Initials': 'MP', 'LastName': 'Safons', 'Affiliation': ''}, {'ForeName': 'Milene S N', 'Initials': 'MSN', 'LastName': 'de Lima', 'Affiliation': ''}, {'ForeName': 'Karina F L', 'Initials': 'KFL', 'LastName': 'Gonçalves', 'Affiliation': ''}, {'ForeName': 'Gerson A', 'Initials': 'GA', 'LastName': 'de Souza Junior', 'Affiliation': ''}, {'ForeName': 'Tito L C', 'Initials': 'TLC', 'LastName': 'Barreto', 'Affiliation': ''}, {'ForeName': 'Anderson José S', 'Initials': 'AJS', 'LastName': 'Oliveira', 'Affiliation': ''}, {'ForeName': 'Alexandre L A', 'Initials': 'ALA', 'LastName': 'Ribeiro', 'Affiliation': ''}, {'ForeName': 'Clarissa C', 'Initials': 'CC', 'LastName': 'Dos Santos Couto Paz', 'Affiliation': ''}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Gentil', 'Affiliation': ''}, {'ForeName': 'Martim', 'Initials': 'M', 'LastName': 'Bottaro', 'Affiliation': ''}, {'ForeName': 'Wagner R', 'Initials': 'WR', 'LastName': 'Martins', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2020-0018'] 4154,33863853,Acute Blood Pressure Effects in Older Adults with Hypertension After Different Modalities of Exercise: An Experimental Study.,"This study investigated the acute blood pressure (BP) effects of different exercise modalities in older adults with hypertension. Sixty volunteers were randomly assigned (n = 15/group) into different exercise protocols: resistance, bike, water-based exercise (WE), and a control session-all for ∼45 min. Clinic BP measurements were taken before, immediately after, and 15 and 30 min after protocols. The data were analyzed by one-way analysis of variance; generalized estimating equations, following Bonferroni post hoc (p < .05). Immediately after exercise, the systolic BP (SBP) increased in all exercise protocols (resistance exercise = Δ10.3, bike exercise = Δ5.8, WE = Δ9.5 mmHg; p < .001), while the diastolic BP was not altered. Afterward, the SBP reached the value observed before exercise. In Minute 30, only WE presented a significant reduction for SBP (WE = Δ-4.6 mmHg; p < .05). This study has important clinical implications in hemodynamic safety for acute BP increases immediately after exercises, as well as, in the SBP, reduction benefits for older adults with hypertension.",2021,"Immediately after exercise, the systolic BP (SBP) increased in all exercise protocols (resistance exercise = Δ10.3, bike exercise = Δ5.8, WE = Δ9.5 mmHg; p < .001), while the diastolic BP was not altered.","['Older Adults with Hypertension', 'Sixty volunteers', 'older adults with hypertension']","['Exercise', 'exercise protocols: resistance, bike, water-based exercise (WE), and a control session-all for ∼45\xa0min', 'exercise modalities']","['Acute Blood Pressure Effects', 'acute blood pressure (BP) effects', 'systolic BP (SBP', 'Clinic BP measurements', 'SBP', 'diastolic BP']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0005375', 'cui_str': 'Bicycle'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",60.0,0.0172386,"Immediately after exercise, the systolic BP (SBP) increased in all exercise protocols (resistance exercise = Δ10.3, bike exercise = Δ5.8, WE = Δ9.5 mmHg; p < .001), while the diastolic BP was not altered.","[{'ForeName': 'Raphael M', 'Initials': 'RM', 'LastName': 'Cunha', 'Affiliation': ''}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Arsa', 'Affiliation': ''}, {'ForeName': 'Iransé', 'Initials': 'I', 'LastName': 'Oliveira-Silva', 'Affiliation': ''}, {'ForeName': 'Izabela', 'Initials': 'I', 'LastName': 'Ferreira Rocha', 'Affiliation': ''}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Machado Lehnen', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2020-0394'] 4155,33863850,Physical Activity in Hospitalized Persons With Dementia: Feasibility and Validity of the MotionWatch 8.,"Persons with dementia are at high risk for hospital-acquired disability, associated with low physical activity during hospitalizations. To determine the effectiveness of efforts to increase physical activity, a valid and reliable measurement approach is required. Data from an ongoing cluster randomized clinical trial examined the feasibility and validity of the MotionWatch 8 (MW8) triaxial actigraphy device. The sample included 321 participants of which 259 (81%) were willing to wear the MW8 for 24 hr. Regression analysis revealed that time in low activity, β = 0.17, t(255) = 2.9, p = .004, and time in moderate activity, β = 0.14, t(255) = 2.4, p = .017, measured by the MW8, were associated with participants' physical function. Engagement in moderate physical activity was associated with return to baseline function at discharge (Wald χ2 = 4.10, df = 1, p = .043). The study provides preliminary support for the feasibility and validity of the MW8 in hospitalized persons with dementia.",2021,"Engagement in moderate physical activity was associated with return to baseline function at discharge (Wald χ2 = 4.10, df = 1, p = .043).","['Persons with dementia are at high risk for hospital-acquired disability, associated with low physical activity during hospitalizations', 'Hospitalized Persons With Dementia', 'hospitalized persons with dementia', '321 participants of which 259 (81%) were willing to wear the MW8 for 24\xa0hr']",['MotionWatch 8 (MW8) triaxial actigraphy device'],"['Physical Activity', 'moderate physical activity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0456393', 'cui_str': 'Hospital acquired'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0600109', 'cui_str': 'Willing'}]","[{'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]",321.0,0.0548053,"Engagement in moderate physical activity was associated with return to baseline function at discharge (Wald χ2 = 4.10, df = 1, p = .043).","[{'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Kuzmik', 'Affiliation': ''}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Resnick', 'Affiliation': ''}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Cacchione', 'Affiliation': ''}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Arendacs', 'Affiliation': ''}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Boltz', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2020-0275'] 4156,33863842,Effect of nurse-led care on outcomes in patients with ACPA/RF-positive rheumatoid arthritis with active disease undergoing treat-to-target: a multicentre randomised controlled trial.,"OBJECTIVE To determine the non-inferiority of nurse-led care (NLC) in patients with anticitrullinated protein antibody (ACPA)-positive and/or rheumatoid factor (RF)-positive rheumatoid arthritis (RA) with active disease who are starting disease-modifying antirheumatic drug therapy, following treat-to-target (T2T) recommendations. METHODS A multicentre, pragmatic randomised controlled trial was conducted to assess clinical effectiveness, anxiety, depression and patient satisfaction following a non-inferiority design. The participants were 224 adults with ACPA/RF-positive RA who were randomly assigned to either NLC or rheumatologist-led care (RLC). The primary outcome was the Disease Activity Score in 28 Joints measured with C reactive protein (DAS28-CRP) assessed at baseline and after 3, 6, 9 and 12 months. A DAS28-CRP difference of 0.6 was set as the non-inferiority margin. Mean differences between the groups were assessed following per-protocol and intention-to-treat strategies. RESULTS Demographic data and baseline characteristics of patients in the NLC group (n=111) were comparable to those of patients in the RLC group (n=113). The improvement in disease activity (change in DAS28-CRP, primary outcome) over the course of 12 months was significant in both groups (p<0.001). No significant differences were observed between the NLC and RLC groups (p=0.317). Non-inferiority of NLC was shown for the primary outcome and all secondary outcomes. CONCLUSION This study supported the non-inferiority of NLC in managing T2T and follow-up care of patients with RA with moderate to high disease activity and poor prognostic factors in addition to RLC. TRIAL REGISTRATION NUMBER DRKS00013055.",2021,"This study supported the non-inferiority of NLC in managing T2T and follow-up care of patients with RA with moderate to high disease activity and poor prognostic factors in addition to RLC. ","['patients with ACPA/RF-positive rheumatoid arthritis with active disease undergoing treat-to-target', 'patients with anticitrullinated protein antibody (ACPA)-positive and/or rheumatoid factor (RF)-positive rheumatoid arthritis (RA) with active disease who are starting disease-modifying antirheumatic drug therapy, following treat-to-target (T2T) recommendations', 'participants were 224 adults with ACPA/RF-positive RA']","['RLC', 'NLC', 'nurse-led care', 'NLC or rheumatologist-led care (RLC', 'nurse-led care (NLC']","['disease activity', 'clinical effectiveness, anxiety, depression and patient satisfaction', 'Disease Activity Score in 28 Joints measured with C reactive protein (DAS28-CRP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1445860', 'cui_str': 'Protein antibody'}, {'cui': 'C0409651', 'cui_str': 'Seropositive rheumatoid arthritis'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0035448', 'cui_str': 'Rheumatoid factor'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0334889', 'cui_str': 'Rheumatologist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",224.0,0.696154,"This study supported the non-inferiority of NLC in managing T2T and follow-up care of patients with RA with moderate to high disease activity and poor prognostic factors in addition to RLC. ","[{'ForeName': 'Juliana Rachel', 'Initials': 'JR', 'LastName': 'Hoeper', 'Affiliation': 'Center for Health Economics Research Hannover (CHERH), Leibniz Universität Hannover, Hannover, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Zeidler', 'Affiliation': 'Center for Health Economics Research Hannover (CHERH), Leibniz Universität Hannover, Hannover, Germany.'}, {'ForeName': 'Sara Eileen', 'Initials': 'SE', 'LastName': 'Meyer', 'Affiliation': 'Rheumatologie and Immunologie, Medizinische Hochschule Hannover, Hannover, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Gauler', 'Affiliation': 'Rheumapraxis an der Hase, Osnabrück, Germany.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Steffens-Korbanka', 'Affiliation': 'Rheumapraxis an der Hase, Osnabrück, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Welcker', 'Affiliation': 'MVZ für Rheumatologie, Planegg, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Wendler', 'Affiliation': 'Internistische Praxisgemeinschaft, Rheumatologie, Erlangen, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Schuch', 'Affiliation': 'Internistische Praxisgemeinschaft, Rheumatologie, Erlangen, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'von Hinüber', 'Affiliation': 'Praxis für Rheumatologie und Osteologie, Hildesheim, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schwarting', 'Affiliation': 'Division of Rheumatology and Clinical Immunology, University Hospital Mainz, Mainz, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Witte', 'Affiliation': 'Rheumatologie and Immunologie, Medizinische Hochschule Hannover, Hannover, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Meyer-Olson', 'Affiliation': 'Rheumatologie and Immunologie, Medizinische Hochschule Hannover, Hannover, Germany.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Hoeper', 'Affiliation': 'Rheumatologie and Immunologie, Medizinische Hochschule Hannover, Hannover, Germany hoeper.kirsten@mh-hannover.de.'}]",RMD open,['10.1136/rmdopen-2021-001627'] 4157,33863614,Worse Preoperative Pain and Higher Activity Levels Predict Patient Choice of Formal Physical Therapy After Primary Anterior Total Hip Arthroplasty.,"BACKGROUND The purpose of this randomized controlled trial is (1) to compare the efficacy of supervised formal physical therapy (PT) and self-directed home exercises and (2) to identify independent predictors of transitioning from self-directed home exercises to supervised formal PT following total hip arthroplasty (THA) via an anterior approach. METHODS After Institutional Review Board approval, 147 patients undergoing primary unilateral THA through anterior approach were enrolled and randomized to receive either clinic or home-based PT. Surveys with Hip Disability Osteoarthritis Outcome Scores (HOOS) and Short Form-12 Health Survey scores for both groups were obtained before surgery and at 6, 14, and 24 weeks after surgery. Patients had the option to transition into the other study group at their 6-week follow-up visit. RESULTS Of the 147 patients enrolled, final analysis included scores for 136 patients. Forty-two (63.6%) of the 66 patients randomized to the supervised formal PT group crossed over to self-directed home exercise group and 12 (17.1%) of the 70 patients randomized to the self-directed home exercise group crossed over to supervised formal PT group. There were no significant (P > .05) differences between groups at all time points for the overall HOOS and Short Form-12 Health Survey. Subjects with worse preoperative pain scores (P = .005) and higher HOOS preoperative activity of daily living scores (P = .015) were more likely to transition from the home exercise group to formal PT group. CONCLUSION There were no significant outcome score differences between subjects undergoing supervised formal PT and self-directed home exercises. However, patients reporting worse preoperative pain and higher preoperative activity levels may prefer supervised formal PT compared to self-directed home exercises after undergoing primary anterior THA.",2021,"Subjects with worse preoperative pain scores (P = .005) and higher HOOS preoperative activity of daily living scores (P = .015) were more likely to transition from the home exercise group to formal PT group. ","['After Primary Anterior Total Hip Arthroplasty', '147 patients enrolled, final analysis included scores for 136 patients', '147 patients undergoing primary unilateral THA through anterior approach']","['clinic or home-based PT', 'Formal Physical Therapy', 'self-directed home exercise group crossed over to supervised formal PT group', 'supervised formal physical therapy (PT) and self-directed home exercises', 'supervised formal PT group crossed over to self-directed home exercise']","['HOOS preoperative activity of daily living scores', 'preoperative pain scores', 'Hip Disability Osteoarthritis Outcome Scores (HOOS) and Short Form-12 Health Survey scores']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205511', 'cui_str': 'Anterior approach'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",147.0,0.0445703,"Subjects with worse preoperative pain scores (P = .005) and higher HOOS preoperative activity of daily living scores (P = .015) were more likely to transition from the home exercise group to formal PT group. ","[{'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Rao', 'Affiliation': 'Orthopedic One, Columbus, OH.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Cieslewicz', 'Affiliation': 'Orthopedic One, Columbus, OH.'}, {'ForeName': 'Kyle R', 'Initials': 'KR', 'LastName': 'Sochacki', 'Affiliation': 'Orthopedic One, Columbus, OH.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kohlrieser', 'Affiliation': 'Department of Physical Therapy and Sports Medicine, Orthopedic One, Columbus, OH.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Moylan', 'Affiliation': 'Orthopedic One, Columbus, OH.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Ellis', 'Affiliation': 'Orthopedic One, Columbus, OH.'}]",The Journal of arthroplasty,['10.1016/j.arth.2021.03.027'] 4158,33863564,Oral selenium improved the disease activity in patients with mild Graves' orbitopathy.,"BACKGROUND Graves' orbitopathy (GO) is the most common extrathyroidal manifestation of Graves' disease (GD), an autoimmune disorder arising from the activity of T lymphocytes against antigens that infiltrate thyroid tissue, orbital tissue and extraocular muscles. An increase in oxidative stress has been discovered in autoimmune thyroid disease, encouraging investigation into new forms of treatment. Selenium has been described as a treatment option given its antioxidant properties. The present study evaluates the decrease of progression and inflammatory signs in patients with mild GO with oral selenium supplementation. METHODS Controlled, randomized, single center trial at an ophthalmology referral center in Mexico City. Patients at least 18years of age with mild GO according to the CAS classification were included; exclusion criteria in addition to corticosteroid treatment included smokers or selenium allergy. Each patient was randomized into one of two groups. Group A took placebo tablets which consisted of 100μg of starch twice a day for 6months, and group B took a 100μg selenium tablet twice a day for 6months. The patients from both groups were examined and evaluated using a CAS score before and after the first, third and sixth month of treatment. RESULTS Thirty eyes of 30 patients were studied. The pretreatment values showed no statistically significant differences between groups (P>0.05). Intergroup analysis showed statistically significant differences in palpebral fissure and CAS score between the pretreatment values and six months after treatment in the selenium group (P<0.05). No differences were found in any variables in the placebo group during the study period (P>0.05). No adverse events were reported. CONCLUSIONS This is the first study in a Mexican population demonstrating that oral selenium decreases clinical activity and stops progression in patients with mild GO.",2021,Intergroup analysis showed statistically significant differences in palpebral fissure and CAS score between the pretreatment values and six months after treatment in the selenium group (P<0.05).,"[""patients with mild Graves' orbitopathy"", 'ophthalmology referral center in Mexico City', 'Mexican population', 'Patients at least 18years of age with mild GO according to the CAS classification were included; exclusion criteria in addition to corticosteroid treatment included smokers or selenium allergy', 'Thirty eyes of 30 patients were studied', 'patients with mild GO with oral selenium supplementation', 'patients with mild GO']","['oral selenium', 'placebo', 'Selenium', 'Oral selenium']","['palpebral fissure and CAS score', 'disease activity', 'CAS score', 'adverse events', 'progression and inflammatory signs', 'oxidative stress']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229244', 'cui_str': 'Structure of palpebral fissure'}, {'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}]",30.0,0.0834201,Intergroup analysis showed statistically significant differences in palpebral fissure and CAS score between the pretreatment values and six months after treatment in the selenium group (P<0.05).,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Almanza-Monterrubio', 'Affiliation': 'Instituto de Oftalmologia Conde de Valenciana, IAP, Chimalpopoca # 14, Colonia Obrera, Delegación Cuauhtemoc, 06800, Mexico City, Mexico.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Garnica-Hayashi', 'Affiliation': 'Instituto de Oftalmologia Conde de Valenciana, IAP, Chimalpopoca # 14, Colonia Obrera, Delegación Cuauhtemoc, 06800, Mexico City, Mexico.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dávila-Camargo', 'Affiliation': 'Instituto de Oftalmologia Conde de Valenciana, IAP, Chimalpopoca # 14, Colonia Obrera, Delegación Cuauhtemoc, 06800, Mexico City, Mexico.'}, {'ForeName': 'Á', 'Initials': 'Á', 'LastName': 'Nava-Castañeda', 'Affiliation': 'Instituto de Oftalmologia Conde de Valenciana, IAP, Chimalpopoca # 14, Colonia Obrera, Delegación Cuauhtemoc, 06800, Mexico City, Mexico. Electronic address: angellusnc@hotmail.com.'}]",Journal francais d'ophtalmologie,['10.1016/j.jfo.2020.08.029'] 4159,33863532,The therapeutic effects of ginkgolides in Guillain-Barré syndrome and experimental autoimmune neuritis.,"BACKGROUND Guillain-Barré syndrome (GBS) is an acquired immune-mediated inflammatory peripheral neuropathy. The immune regulation of ginkgolides have been revealed in recent years. We herein investigate the potential therapeutic effects of ginkgolides both on GBS and its animal model, experimental autoimmune neuritis (EAN). METHODS EAN in C57BL/6 mice induced by subcutaneous injection with peripheral nerve myelin P0 protein peptide 180-199 (P0 peptide) were treated with ginkgolides at three different doses. GBS patients were randomly divided into two groups, the experimental group and the control group. The experimental group were treated with ginkgolides as soon as diagnosed. RESULTS Our data indicated that ginkgolides administration daily ameliorated the score of EAN and delayed the peak of disease in EAN mice. Ginkgolides also down-regulated the proportions of T helper (Th) 17 cells in EAN spleens. Furthermore, we also found that administration of ginkgolides significantly decreased the levels of interferon (IFN)-γ and interleukin-12 (IL)-12 in GBS patients. CONCLUSIONS Our results suggested that ginkgolides ameliorated the clinical score of EAN through down-regulating the proportions of Th 17 cells. Ginkgolides also suppressed inflammation response by decreasing pro-inflammatory cytokines IFN-γ and IL-12, suggesting ginkgolides had potential therapeutic effects on GBS patients and EAN in the future.",2021,Ginkgolides also down-regulated the proportions of T helper (Th) 17 cells in EAN spleens.,"['EAN in C57BL/6 mice induced by subcutaneous injection with peripheral nerve myelin P0 protein peptide 180-199 (P0 peptide', 'GBS patients', 'Guillain-Barré syndrome and experimental autoimmune neuritis']",[],"['inflammation response', 'levels of interferon (IFN)-γ and interleukin-12 (IL)-12', 'score of EAN']","[{'cui': 'C0027814', 'cui_str': 'Autoimmune Neuritis, Experimental'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C0031119', 'cui_str': 'Peripheral nerve structure'}, {'cui': 'C0071316', 'cui_str': 'Protein Zero, Peripheral Nerve Myelin'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0018378', 'cui_str': 'Guillain-Barré syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027814', 'cui_str': 'Autoimmune Neuritis, Experimental'}]",,0.0359832,Ginkgolides also down-regulated the proportions of T helper (Th) 17 cells in EAN spleens.,"[{'ForeName': 'Chunrong', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Neuroscience Center, Department of Neurology, The First Hospital of Jilin University, Jilin University, Changchun, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Neuroscience Center, Department of Neurology, The First Hospital of Jilin University, Jilin University, Changchun, China.'}, {'ForeName': 'Qiaolifan', 'Initials': 'Q', 'LastName': 'Aerqin', 'Affiliation': 'Neuroscience Center, Department of Neurology, The First Hospital of Jilin University, Jilin University, Changchun, China.'}, {'ForeName': 'Donghui', 'Initials': 'D', 'LastName': 'Shen', 'Affiliation': 'Neuroscience Center, Department of Neurology, The First Hospital of Jilin University, Jilin University, Changchun, China.'}, {'ForeName': 'Xiujuan', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Neuroscience Center, Department of Neurology, The First Hospital of Jilin University, Jilin University, Changchun, China.'}, {'ForeName': 'Kangding', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Neuroscience Center, Department of Neurology, The First Hospital of Jilin University, Jilin University, Changchun, China. Electronic address: liukd@jlu.edu.cn.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2021.02.016'] 4160,33863383,"A novel MSC-based immune induction strategy for ABO-incompatible liver transplantation: a phase I/II randomized, open-label, controlled trial.","BACKGROUND ABO-incompatible liver transplantation (ABO-i LT) has become a rescue therapeutic option for patients with severe hepatic failure. Although the use of rituximab greatly reduces the morbidity of antibody-mediated rejection (AMR), severe adverse effects, such as infection and biliary complications, still seriously threaten the survival of transplant recipients. The aim of this study was to evaluate the safety and feasibility of using mesenchymal stem cells (MSCs) to replace rituximab in ABO-i LT. METHODS Twenty-two patients with severe hepatic failure undergoing ABO-i LT were enrolled and randomly divided into two groups: the MSC group and the rituximab group. The safety of the application of MSCs and the incidence of allograft rejection, including antibody-mediated rejection (AMR) and acute cellular rejection (ACR), were evaluated in both groups at the 2-year follow-up period as primary endpoints. Recipients and graft survival and other postoperative complications were compared as secondary endpoints. RESULTS No severe MSC-related adverse events were observed during the trial. MSC treatment yielded comparable, if not better, results than rituximab at decreasing the incidence of acute rejection (9.1% vs 27.3%). Inspiringly, compared to those in the rituximab group, the rates of biliary complications (0% vs 45.5%) and infection (9.1% vs 81.8%) were significantly decreased in the MSC group. In addition, there were no significant differences in 2-year graft and recipient survival between the two groups (81.8% vs 72.7%). CONCLUSIONS Our data show that MSC transfusion is comparable to rituximab treatment for AMR prophylaxis following ABO-i LT. Additionally, the results indicate that MSCs are more beneficial to the prevention of infection and biliary complications and may be introduced as a novel immunosuppressive approach for ABO-i LT. TRIAL REGISTRATION Trial registration: chictr.org.cn , ChiCTR2000037732. Registered 31 August 2020- Retrospectively registered, http://www.chictr.org.cn/showproj.aspx?proj=57074 .",2021,"MSC treatment yielded comparable, if not better, results than rituximab at decreasing the incidence of acute rejection (9.1% vs 27.3%).","['Registered 31 August 2020', 'Twenty-two patients with severe hepatic failure undergoing ABO-i LT', 'ABO-incompatible liver transplantation', 'patients with severe hepatic failure']","['mesenchymal stem cells (MSCs) to replace rituximab', 'MSC', 'rituximab', 'ABO-incompatible liver transplantation (ABO-i LT']","['rates of biliary complications', '2-year graft and recipient survival', 'safety and feasibility', 'morbidity of antibody-mediated rejection (AMR), severe adverse effects', 'severe MSC-related adverse events', 'incidence of acute rejection', 'infection', 'allograft rejection, including antibody-mediated rejection (AMR) and acute cellular rejection (ACR', 'graft survival and other postoperative complications']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0085605', 'cui_str': 'Hepatic failure'}, {'cui': 'C0078140', 'cui_str': 'VBM protocol'}, {'cui': 'C0013184', 'cui_str': 'Drug Incompatibility'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}]","[{'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0074299', 'cui_str': 'selenomethylselenocysteine'}, {'cui': 'C0078140', 'cui_str': 'VBM protocol'}, {'cui': 'C0013184', 'cui_str': 'Drug Incompatibility'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1608421', 'cui_str': 'Antibody-mediated rejection'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0074299', 'cui_str': 'selenomethylselenocysteine'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0877453', 'cui_str': 'Acute cellular rejection'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",22.0,0.048232,"MSC treatment yielded comparable, if not better, results than rituximab at decreasing the incidence of acute rejection (9.1% vs 27.3%).","[{'ForeName': 'Yingcai', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Hepatic Surgery and Liver Transplantation Center of the Third Affiliated Hospital, Organ Transplantation Institute, Sun Yat-sen University, Guangzhou, 510630, Guangdong, China.'}, {'ForeName': 'Jiebin', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Hepatic Surgery and Liver Transplantation Center of the Third Affiliated Hospital, Organ Transplantation Institute, Sun Yat-sen University, Guangzhou, 510630, Guangdong, China.'}, {'ForeName': 'Huimin', 'Initials': 'H', 'LastName': 'Yi', 'Affiliation': 'Surgical Intensive Care Unit, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510630, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'Department of Hepatic Surgery and Liver Transplantation Center of the Third Affiliated Hospital, Organ Transplantation Institute, Sun Yat-sen University, Guangzhou, 510630, Guangdong, China.'}, {'ForeName': 'Jianye', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': 'Department of Hepatic Surgery and Liver Transplantation Center of the Third Affiliated Hospital, Organ Transplantation Institute, Sun Yat-sen University, Guangzhou, 510630, Guangdong, China.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Cell-gene Therapy Translational Medicine Research Center, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510630, Guangdong, China.'}, {'ForeName': 'Tongyu', 'Initials': 'T', 'LastName': 'Lu', 'Affiliation': 'Department of Hepatic Surgery and Liver Transplantation Center of the Third Affiliated Hospital, Organ Transplantation Institute, Sun Yat-sen University, Guangzhou, 510630, Guangdong, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Hepatic Surgery and Liver Transplantation Center of the Third Affiliated Hospital, Organ Transplantation Institute, Sun Yat-sen University, Guangzhou, 510630, Guangdong, China.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Du', 'Affiliation': 'Cell-gene Therapy Translational Medicine Research Center, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510630, Guangdong, China.'}, {'ForeName': 'Jianrong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Surgical Intensive Care Unit, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510630, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': 'Department of Hepatic Surgery and Liver Transplantation Center of the Third Affiliated Hospital, Organ Transplantation Institute, Sun Yat-sen University, Guangzhou, 510630, Guangdong, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Hepatic Surgery and Liver Transplantation Center of the Third Affiliated Hospital, Organ Transplantation Institute, Sun Yat-sen University, Guangzhou, 510630, Guangdong, China.'}, {'ForeName': 'Guoying', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Hepatic Surgery and Liver Transplantation Center of the Third Affiliated Hospital, Organ Transplantation Institute, Sun Yat-sen University, Guangzhou, 510630, Guangdong, China.'}, {'ForeName': 'Binsheng', 'Initials': 'B', 'LastName': 'Fu', 'Affiliation': 'Department of Hepatic Surgery and Liver Transplantation Center of the Third Affiliated Hospital, Organ Transplantation Institute, Sun Yat-sen University, Guangzhou, 510630, Guangdong, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of Hepatic Surgery and Liver Transplantation Center of the Third Affiliated Hospital, Organ Transplantation Institute, Sun Yat-sen University, Guangzhou, 510630, Guangdong, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Hepatic Surgery and Liver Transplantation Center of the Third Affiliated Hospital, Organ Transplantation Institute, Sun Yat-sen University, Guangzhou, 510630, Guangdong, China.'}, {'ForeName': 'Genshu', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Hepatic Surgery and Liver Transplantation Center of the Third Affiliated Hospital, Organ Transplantation Institute, Sun Yat-sen University, Guangzhou, 510630, Guangdong, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Hepatic Surgery and Liver Transplantation Center of the Third Affiliated Hospital, Organ Transplantation Institute, Sun Yat-sen University, Guangzhou, 510630, Guangdong, China.'}, {'ForeName': 'Andy Peng', 'Initials': 'AP', 'LastName': 'Xiang', 'Affiliation': 'Center for Stem Cell Biology and Tissue Engineering, Key Laboratory for Stem Cells and Tissue Engineering, Ministry of Education, Sun Yat-Sen University, Guangzhou, 510080, China.'}, {'ForeName': 'Guihua', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Department of Hepatic Surgery and Liver Transplantation Center of the Third Affiliated Hospital, Organ Transplantation Institute, Sun Yat-sen University, Guangzhou, 510630, Guangdong, China.'}, {'ForeName': 'Shuhong', 'Initials': 'S', 'LastName': 'Yi', 'Affiliation': 'Department of Hepatic Surgery and Liver Transplantation Center of the Third Affiliated Hospital, Organ Transplantation Institute, Sun Yat-sen University, Guangzhou, 510630, Guangdong, China. yishuhong@163.com.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Cell-gene Therapy Translational Medicine Research Center, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510630, Guangdong, China. zhangq27@mail.sysu.edu.cn.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Hepatic Surgery and Liver Transplantation Center of the Third Affiliated Hospital, Organ Transplantation Institute, Sun Yat-sen University, Guangzhou, 510630, Guangdong, China. yysysu@163.com.'}]",Stem cell research & therapy,['10.1186/s13287-021-02246-4'] 4161,33863326,An Integrated eDiagnosis Approach (IeDA) versus standard IMCI for assessing and managing childhood illness in Burkina Faso: a stepped-wedge cluster randomised trial.,"BACKGROUND The Integrated eDiagnosis Approach (IeDA), centred on an electronic Clinical Decision Support System (eCDSS) developed in line with national Integrated Management of Childhood Illness (IMCI) guidelines, was implemented in primary health facilities of two regions of Burkina Faso. An evaluation was performed using a stepped-wedge cluster randomised design with the aim of determining whether the IeDA intervention increased Health Care Workers' (HCW) adherence to the IMCI guidelines. METHODS Ten randomly selected facilities per district were visited at each step by two trained nurses: One observed under-five consultations and the second conducted a repeat consultation. The primary outcomes were: overall adherence to clinical assessment tasks; overall correct classification ignoring the severity of the classifications; and overall correct prescription according to HCWs' classifications. Statistical comparisons between trial arms were performed on cluster/step-level summaries. RESULTS On average, 54 and 79% of clinical assessment tasks were observed to be completed by HCWs in the control and intervention districts respectively (cluster-level mean difference = 29.9%; P-value = 0.002). The proportion of children for whom the validation nurses and the HCWs recorded the same classifications (ignoring the severity) was 73 and 79% in the control and intervention districts respectively (cluster-level mean difference = 10.1%; P-value = 0.004). The proportion of children who received correct prescriptions in accordance with HCWs' classifications were similar across arms, 78% in the control arm and 77% in the intervention arm (cluster-level mean difference = - 1.1%; P-value = 0.788). CONCLUSION The IeDA intervention improved substantially HCWs' adherence to IMCI's clinical assessment tasks, leading to some overall increase in correct classifications but to no overall improvement in correct prescriptions. The largest improvements tended to be observed for less common conditions. For more common conditions, HCWs in the control districts performed relatively well, thus limiting the scope to detect an overall impact. TRIAL REGISTRATION ClinicalTrials.gov NCT02341469 ; First submitted August 272,014, posted January 19, 2015.",2021,"For more common conditions, HCWs in the control districts performed relatively well, thus limiting the scope to detect an overall impact. ","['Ten randomly selected facilities per district were visited at each step by two trained nurses', 'Burkina Faso']","['Integrated eDiagnosis Approach (IeDA) versus standard IMCI', 'IeDA intervention']","[""overall adherence to clinical assessment tasks; overall correct classification ignoring the severity of the classifications; and overall correct prescription according to HCWs' classifications"", ""substantially HCWs' adherence"", ""Health Care Workers' (HCW) adherence""]","[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0006409', 'cui_str': 'Burkina Faso'}]","[{'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]",10.0,0.179132,"For more common conditions, HCWs in the control districts performed relatively well, thus limiting the scope to detect an overall impact. ","[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Sarrassat', 'Affiliation': 'Centre for Maternal Adolescent Reproductive and Child Health (MARCH), London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. sophie.sarrassat@lshtm.ac.uk.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Lewis', 'Affiliation': 'Y Lab, the Public Services Innovation Lab for Wales, School of Social Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Arsene S', 'Initials': 'AS', 'LastName': 'Some', 'Affiliation': 'Centre Muraz, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Somda', 'Affiliation': 'Centre Muraz, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Cousens', 'Affiliation': 'Centre for Maternal Adolescent Reproductive and Child Health (MARCH), London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Blanchet', 'Affiliation': 'Centre for Maternal Adolescent Reproductive and Child Health (MARCH), London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}]",BMC health services research,['10.1186/s12913-021-06317-3'] 4162,33863315,Comparing the characteristics and predicting the survival of patients with head and neck melanoma versus body melanoma: a population-based study.,"BACKGROUND Previous studies reported cutaneous melanoma in head and neck (HNM) differed from those in other regions (body melanoma, BM). Individualized tools to predict the survival of patients with HNM or BM remain insufficient. We aimed at comparing the characteristics of HNM and BM, developing and validating nomograms for predicting the survival of patients with HNM or BM. METHODS The information of patients with HNM or BM from 2004 to 2015 was obtained from the Surveillance, Epidemiology, and End Results (SEER) database. The HNM group and BM group were randomly divided into training and validation cohorts. We used the Kaplan-Meier method and multivariate Cox models to identify independent prognostic factors. Nomograms were developed via the rms and dynnom packages, and were measured by the concordance index (C-index), the area under the curve (AUC) of the receiver operating characteristic (ROC) curve and calibration plots. RESULTS Of 70,605 patients acquired, 21% had HNM and 79% had BM. The HNM group contained more older patients, male sex and lentigo maligna melanoma, and more frequently had thicker tumors and metastases than the BM group. The 5-year cancer-specific survival (CSS) and overall survival (OS) rates were 88.1 ± 0.3% and 74.4 ± 0.4% in the HNM group and 92.5 ± 0.1% and 85.8 ± 0.2% in the BM group, respectively. Eight variables (age, sex, histology, thickness, ulceration, stage, metastases, and surgery) were identified to construct nomograms of CSS and OS for patients with HNM or BM. Additionally, four dynamic nomograms were available on web. The internal and external validation of each nomogram showed high C-index values (0.785-0.896) and AUC values (0.81-0.925), and the calibration plots showed great consistency. CONCLUSIONS The characteristics of HNM and BM are heterogeneous. We constructed and validated four nomograms for predicting the 3-, 5- and 10-year CSS and OS probabilities of patients with HNM or BM. These nomograms can serve as practical clinical tools for survival prediction and individual health management.",2021,"The 5-year cancer-specific survival (CSS) and overall survival (OS) rates were 88.1 ± 0.3% and 74.4 ± 0.4% in the HNM group and 92.5 ± 0.1% and 85.8 ± 0.2% in the BM group, respectively.","['patients with HNM or BM remain insufficient', 'patients with HNM or BM', '70,605 patients acquired', 'patients with head and neck melanoma versus body melanoma']",['HNM'],"['concordance index (C-index), the area under the curve (AUC) of the receiver operating characteristic (ROC) curve and calibration plots', 'AUC values', '5-year cancer-specific survival (CSS) and overall survival (OS) rates', 'BM', 'C-index values']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}]",[],"[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0006751', 'cui_str': 'Calibration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",70605.0,0.0920587,"The 5-year cancer-specific survival (CSS) and overall survival (OS) rates were 88.1 ± 0.3% and 74.4 ± 0.4% in the HNM group and 92.5 ± 0.1% and 85.8 ± 0.2% in the BM group, respectively.","[{'ForeName': 'Yuxin', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Department of Dermatology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China, No. 88, Jiefang Road, Hangzhou, 310009, China.'}, {'ForeName': 'Runyi', 'Initials': 'R', 'LastName': 'Jiang', 'Affiliation': 'Spinal Tumor Center, Department of Orthopaedic Oncology, Changzheng Hospital, Second Military Medical University, Shanghai, 200003, China.'}, {'ForeName': 'Yuhong', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Dermatology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China, No. 88, Jiefang Road, Hangzhou, 310009, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jing', 'Affiliation': 'Department of Dermatology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China, No. 88, Jiefang Road, Hangzhou, 310009, China.'}, {'ForeName': 'Xiaoshuang', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Dermatology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China, No. 88, Jiefang Road, Hangzhou, 310009, China.'}, {'ForeName': 'Xianjie', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Dermatology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China, No. 88, Jiefang Road, Hangzhou, 310009, China.'}, {'ForeName': 'Xiaoyang', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Dermatology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China, No. 88, Jiefang Road, Hangzhou, 310009, China.'}, {'ForeName': 'Jiali', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Dermatology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China, No. 88, Jiefang Road, Hangzhou, 310009, China.'}, {'ForeName': 'Piaopiao', 'Initials': 'P', 'LastName': 'Xu', 'Affiliation': 'Department of Dermatology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China, No. 88, Jiefang Road, Hangzhou, 310009, China.'}, {'ForeName': 'Shu Chen', 'Initials': 'SC', 'LastName': 'LiuHuang', 'Affiliation': 'China Academy of Art, Hangzhou, 310000, China.'}, {'ForeName': 'Zhongfa', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': 'Department of Dermatology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China, No. 88, Jiefang Road, Hangzhou, 310009, China. lzfskin@zju.edu.cn.'}]",BMC cancer,['10.1186/s12885-021-08105-y'] 4163,33863305,"The effect of sevoflurane anesthesia for dental procedure on neurocognition in children: a prospective, equivalence, controlled trial.","BACKGROUND Dental procedures under general anesthesia (DGA) was found to improve the oral health-related quality of children's life. However, some parents and pediatricians expressed concern about the neurotoxicity of general anesthesia. The purpose of this trial was to whether DGA in children has an adverse effect on neurocognition. METHODS In this prospective, assessor-masked, controlled, equivalence trial, we recruited 340 children younger than 7 years who were undergoing caries treatment between Feb 1, 2019, and Aug 31, 2019, without factors affecting neurodevelopment. They received either sevoflurane-based general anesthesia or awake-local anesthesia. The Wechsler Preschool and Primary Scale of Intelligence-Fourth Edition was used to evaluate the neurocognitive function of children at 6 months after surgery, and the Full-Scale IQ (FSIQ) was selected as the primary outcome. The predefined clinical equivalence margin was 5 (1/3 SD of FSIQ score). If the 95% CI of the difference between the average FSIQ score of the two groups is within - 5 to + 5, then the two groups are equivalent. RESULTS The outcome data were obtained from 129 children in the general anesthesia group and 144 in the local anesthesia group. The median length of general anesthesia was 130 min (IQR 110-160). The mean FSIQ score in the general anesthesia group was 103·12 (SD 8.94), and the mean of the local anesthesia group was 103·58 (SD 8.40). There was equivalence in means of FSIQ score between the two groups (local minus general anesthesia 0.46, 95% CI - 2.35 to 1.61). There was no significant difference in FSIQ scores between different age groups and different anesthesia durations. Only the mother's education could affect the primary outcome. CONCLUSIONS In this trial, prolonged DGA with a sevoflurane-only anesthetic in preschool children, does not adversely affect neurocognitive function at 6 months after surgery compared with awake-local anesthesia. TRIAL REGISTRATION Chinese Clinical Trial Registry, ChiCTR1800015216 . Registered Mar 15 2018.",2021,"There was equivalence in means of FSIQ score between the two groups (local minus general anesthesia 0.46, 95% CI - 2.35 to 1.61).","['children', '340 children younger than 7\u2009years who were undergoing caries treatment between Feb 1, 2019, and Aug 31, 2019, without factors affecting neurodevelopment', 'preschool children', '129 children in the general anesthesia group and 144 in the local anesthesia group']","['sevoflurane-based general anesthesia or awake-local anesthesia', 'sevoflurane-only anesthetic', 'DGA', 'sevoflurane anesthesia']","['average FSIQ score', 'FSIQ score', 'neurocognitive function', 'mean FSIQ score', 'FSIQ scores', 'Full-Scale IQ (FSIQ', 'median length of general anesthesia']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0011331', 'cui_str': 'Dental care'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]",340.0,0.175251,"There was equivalence in means of FSIQ score between the two groups (local minus general anesthesia 0.46, 95% CI - 2.35 to 1.61).","[{'ForeName': 'Pinping', 'Initials': 'P', 'LastName': 'Zhou', 'Affiliation': 'College of Stomatology, Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Chongqing Key Laboratory for Oral Diseases and Biomedical Sciences, Chongqing, China.'}, {'ForeName': 'Guijin', 'Initials': 'G', 'LastName': 'Huang', 'Affiliation': 'Chongqing Key Laboratory for Oral Diseases and Biomedical Sciences, Chongqing, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Chongqing Key Laboratory for Oral Diseases and Biomedical Sciences, Chongqing, China.'}, {'ForeName': 'Wenzhu', 'Initials': 'W', 'LastName': 'Ma', 'Affiliation': 'Chongqing Key Laboratory for Oral Diseases and Biomedical Sciences, Chongqing, China.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Chongqing Key Laboratory for Oral Diseases and Biomedical Sciences, Chongqing, China. 500158@hospital.cqmu.edu.cn.'}]",BMC pediatrics,['10.1186/s12887-021-02649-5'] 4164,33863276,Assessing the feasibility and acceptability of a cluster-randomized study of cognitive behavioral therapy for chronic insomnia in a primary care setting.,"BACKGROUND Cognitive behavioral therapy for chronic insomnia (CBT-i) is the treatment of choice for this condition but is underutilized in patients who attend primary care. The purpose of the present feasibility-pilot study was to assess the feasibility and acceptability of a cluster-randomized study of CBT-i in a primary care setting. METHODS This study, performed at two primary health care centers in Majorca, Spain, was a mixed methods feasibility-pilot study of a parallel cluster-randomized design comparing CBT-i and usual care (UC). Patients were included if they were 18 to 65 years-old; had diagnoses of chronic insomnia according to the Insomnia Severity Index (ISI ≥ 8); had insomnia for more than 3 months. Twenty-five GPs and nurses and 32 patients were randomly allocated to two groups. The main outcome of the intervention was improvement of dimensions of sleep quality, measured using the Spanish version of the Pittsburgh Sleep Quality Index, at baseline and at 3 months after the intervention. Other primary outcomes of the study were the feasibility and applicability of the intervention, collected through nominal groups. A thematic analysis was performed to classify primary care provider (PCP) proposals. Additionally, we assessed the recruitment process, compliance with the intervention sessions, and patient retention. RESULTS We adapted the CBT-i approach of Morin to a primary care context. After intervention training, PCPs expressed the need for more extensive training in the different aspects of the therapy and the discussion of more cases. PCPs considered the intervention as adequate but wanted fewer but longer sessions as well as to discard the cognitive restructuring component. PCPs considered it crucial to prepare each session in advance and to establish a specific agenda for the CBT-i. Regular reminders given to PCPs and patients were suggested to improve study participation. Compared to the UC group, higher proportions of patients in the intervention group had short sleep latency, slept for longer than 5 h, and had fewer sleep disruptions. CONCLUSIONS This feasibility-pilot study identified several key issues that must be addressed before performing a CBT-i intervention in future clinical trial in a primary care setting. TRIAL REGISTRATION NCT04565223 . (Clinical trials.gov) Registered 1 September 2020-Retrospectively registered.",2021,"After intervention training, PCPs expressed the need for more extensive training in the different aspects of the therapy and the discussion of more cases.","['two primary health care centers in Majorca, Spain', 'patients who attend primary care', 'chronic insomnia in a primary care setting', 'Twenty-five GPs and nurses and 32 patients', 'Patients were included if they were 18 to 65\xa0years-old; had diagnoses of chronic insomnia according to the Insomnia Severity Index (ISI\u2009≥\u20098); had insomnia for more than 3\xa0months']","['CBT', 'cognitive behavioral therapy', 'CBT-i intervention', 'Cognitive behavioral therapy', 'CBT-i and usual care (UC']","['short sleep latency, slept', 'feasibility and acceptability', 'dimensions of sleep quality, measured using the Spanish version of the Pittsburgh Sleep Quality Index']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454825', 'cui_str': 'Mallorca'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0272302', 'cui_str': 'Gray platelet syndrome'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}]",25.0,0.02751,"After intervention training, PCPs expressed the need for more extensive training in the different aspects of the therapy and the discussion of more cases.","[{'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Torrens', 'Affiliation': 'Santa Ponsa Health Center, Majorca Department of Primary Care, Baleares Health Service [IbSalut], Riu Síl, 25, 07180, Santa Ponça, Majorca, Spain.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Esteva', 'Affiliation': 'Balearic Islands Health Research Institute (IdISBa), Edificio S, University Hospital Son Espases, Carretera de Valldemossa, 79, 07120, Palma, Majorca, Spain. magdalena.estevacanto@ibsalut.es.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Vicens', 'Affiliation': 'Balearic Islands Health Research Institute (IdISBa), Edificio S, University Hospital Son Espases, Carretera de Valldemossa, 79, 07120, Palma, Majorca, Spain.'}, {'ForeName': 'María Rosa', 'Initials': 'MR', 'LastName': 'Pizá-Portell', 'Affiliation': 'Santa Ponsa Health Center, Majorca Department of Primary Care, Baleares Health Service [IbSalut], Riu Síl, 25, 07180, Santa Ponça, Majorca, Spain.'}, {'ForeName': 'María Clara', 'Initials': 'MC', 'LastName': 'Vidal-Thomàs', 'Affiliation': 'Balearic Islands Health Research Institute (IdISBa), Edificio S, University Hospital Son Espases, Carretera de Valldemossa, 79, 07120, Palma, Majorca, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Vidal-Ribas', 'Affiliation': 'Santa Ponsa Health Center, Majorca Department of Primary Care, Baleares Health Service [IbSalut], Riu Síl, 25, 07180, Santa Ponça, Majorca, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Lorente-Montalvo', 'Affiliation': 'Santa Ponsa Health Center, Majorca Department of Primary Care, Baleares Health Service [IbSalut], Riu Síl, 25, 07180, Santa Ponça, Majorca, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Torres-Solera', 'Affiliation': 'Primary Care Research Unit, Majorca Department of Primary Care, Baleares Health Service [IbSalut], Escola Graduada 3, 07001, Palma, Spain.'}]",BMC family practice,['10.1186/s12875-021-01429-5'] 4165,33862467,The effect of a food addiction explanatory model of eating behaviours on weight-based stigma: An experimental investigation.,"Weight stigmatization and discrimination are pervasive issues that have numerous adverse consequences for those with excess weight. It has been proposed that some individuals may be addicted to hyperpalatable processed foods, resulting in weight promoting eating behaviours. The current study replicated and extended a study examining the effect of a food addiction explanation for eating behaviours on weight-based stigma and weight-controllability beliefs. Undergraduate students (N = 757) were randomly assigned to one of four conditions where they read a newspaper article accompanied by a photo of a woman 1) who was either of a higher body mass index (BMI) or a lower BMI, and 2) that attributed her eating behaviours to either food addiction or poor dietary and lifestyle choices. Stigma towards the woman and individuals with a higher BMI in general were assessed. Results indicated that the woman with a higher BMI elicited greater weight stigma. Attributing weight to food addiction increased perceptions of psychopathology towards the woman, whereas attributing weight to poor dietary and lifestyle choices elicited judgment towards the woman. Neither explanation about eating behaviours elicited stigma towards individuals with a higher BMI in general. Findings suggest that a food addiction explanation alone may not be sufficient to reduce weight stigma.",2021,"Attributing weight to food addiction increased perceptions of psychopathology towards the woman, whereas attributing weight to poor dietary and lifestyle choices elicited judgment towards the woman.","['eating behaviours on weight-based stigma', 'Undergraduate students (N\xa0=\xa0757']","['food addiction explanation', 'food addiction or poor dietary and lifestyle choices']","['weight-based stigma and weight-controllability beliefs', 'weight stigma']","[{'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C4505163', 'cui_str': 'Food Addiction'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",757.0,0.0537408,"Attributing weight to food addiction increased perceptions of psychopathology towards the woman, whereas attributing weight to poor dietary and lifestyle choices elicited judgment towards the woman.","[{'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Montemarano', 'Affiliation': 'Department of Psychology, Ryerson University, 350 Victoria Street, Toronto M5B 2K3, Ontario, Canada. Electronic address: vanessa.montemarano@ryerson.ca.'}, {'ForeName': 'Stephanie E', 'Initials': 'SE', 'LastName': 'Cassin', 'Affiliation': 'Department of Psychology, Ryerson University, 350 Victoria Street, Toronto M5B 2K3, Ontario, Canada.'}]",Eating behaviors,['10.1016/j.eatbeh.2021.101507'] 4166,33862407,Approach bias retraining through virtual reality in smokers willing to quit smoking: A randomized-controlled study.,"Automatic approach biases toward smoking-related cues have been implicated in the development and maintenance of addictive behaviors. Studies aiming at modifying such biases have shown promise in changing maladaptive approach tendencies for smoking cues and reducing smoking behavior. However, training effects tend to be small and partly inconsistent. The present randomized-controlled trial incorporated virtual reality (VR) technology into Approach Bias Modification (ABM) to improve efficacy. One-hundred-eight smokers attended behavioral counseling for smoking cessation and were thereafter randomized to receive VR-ABM or VR-control training. During VR-ABM, participants trained to implicitly avoid smoking-related objects and to approach alternative objects, while no such contingency existed in the VR-control condition. Trainings were administered in six sessions within a two-week period. Assessments were conducted at baseline, post-intervention (three weeks after baseline), and at follow-up (seven weeks after baseline). VR-ABM did not change approach biases, nor other cognitive biases, but it was superior in reducing daily smoking. However, this effect was limited to the two-week training period. Both groups improved in other smoking- and health-related variables across time. Future work should continue to investigate working mechanisms of ABM, in particular crucial training ingredients. VR could prove valuable for public health as the potential of VR-based treatments is large and not fully explored.",2021,"VR-ABM did not change approach biases, nor other cognitive biases, but it was superior in reducing daily smoking.","['smokers willing to quit smoking', 'One-hundred-eight smokers attended behavioral counseling for smoking cessation']","['Approach bias retraining through virtual reality', 'VR-ABM or VR-control training', 'virtual reality (VR) technology into Approach Bias Modification (ABM']",[],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling'}]","[{'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]",[],,0.0170703,"VR-ABM did not change approach biases, nor other cognitive biases, but it was superior in reducing daily smoking.","[{'ForeName': 'Alla', 'Initials': 'A', 'LastName': 'Machulska', 'Affiliation': 'Department of Clinical Psychology, University of Siegen, Siegen, Germany. Electronic address: alla.machulska@uni-siegen.de.'}, {'ForeName': 'Tanja Joan', 'Initials': 'TJ', 'LastName': 'Eiler', 'Affiliation': 'Medical Informatics and Micro Systems Engineering, University of Siegen, Siegen, Germany; Life Science Faculty, University of Siegen, Siegen, Germany. Electronic address: tanja.eiler@uni-siegen.de.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Kleinke', 'Affiliation': 'Department of Clinical Psychology, University of Siegen, Siegen, Germany. Electronic address: kristian.kleinke@uni-siegen.de.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Grünewald', 'Affiliation': 'Medical Informatics and Micro Systems Engineering, University of Siegen, Siegen, Germany; Life Science Faculty, University of Siegen, Siegen, Germany. Electronic address: armin.gruenewald@uni-siegen.de.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Brück', 'Affiliation': 'Life Science Faculty, University of Siegen, Siegen, Germany. Electronic address: rainer.brueck@uni-siegen.de.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Jahn', 'Affiliation': 'Department of Business Informatics, University of Siegen, Siegen, Germany. Electronic address: katharina.jahn@uni-siegen.de.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Niehaves', 'Affiliation': 'Department of Business Informatics, University of Siegen, Siegen, Germany. Electronic address: bjoern.niehaves@uni-siegen.de.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Klucken', 'Affiliation': 'Department of Clinical Psychology, University of Siegen, Siegen, Germany. Electronic address: tim.klucken@uni-siegen.de.'}]",Behaviour research and therapy,['10.1016/j.brat.2021.103858'] 4167,33862377,Effects of locomotion task constraints on running in boys with overweight/obesity: The mediating role of developmental delays.,"BACKGROUND Childhood obesity adversely affects the musculoskeletal system and is accompanied with motor development delays. Movement interventions that change the body composition and movement patterns is suggested as an effective way to minimise the childhood obesity adverse effects. RESEARCH QUESTION Whether a locomotion task constraints intervention is effective to change body composition, motor performance and running efficiency in overweight/obese boys with different levels of motor development. METHODS Forty young boys (age: 8.21 ± 1.01 years) whose body mass index (BMI) was above the 85th normative ranked score were divided into 4 independent groups according to their development and BMI: intervention-typical, intervention-delay, control-typical and control-delay. A 6-week task constraints intervention with an emphasis on improving locomotion skills such as fast walking, running, jumping, hopping, skipping and leaping were carried out in the intervention group. RESULTS The pre and post-intervention difference score on the sample dependent variables showed decreases in body mass and BMI and improvements in agility, joint kinematics and running economy in the intervention-typical group relative to other groups. SIGNIFICANCE The findings highlight that the boys with overweight/obesity and typical development can benefit more from a short-term developmentally-appropriate intervention to refine the running pattern and agility skill that was accompanied by positive changes in body composition.",2021,"Whether a locomotion task constraints intervention is effective to change body composition, motor performance and running efficiency in overweight/obese boys with different levels of motor development. ","['Forty young boys (age: 8.21\u202f±\u202f1.01 years) whose body mass index (BMI) was above the 85th normative ranked score', 'overweight/obese boys with different levels of motor development', 'boys with overweight/obesity']","['locomotion task constraints intervention', 'BMI: intervention-typical, intervention-delay, control-typical and control-delay', 'locomotion task constraints']","['body mass and BMI and improvements in agility, joint kinematics and running economy']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]","[{'cui': 'C0023946', 'cui_str': 'Locomotor Activity'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",40.0,0.0204346,"Whether a locomotion task constraints intervention is effective to change body composition, motor performance and running efficiency in overweight/obese boys with different levels of motor development. ","[{'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Shafizadeh', 'Affiliation': 'College of Health, Wellbeing and Life Sciences, Sheffield Hallam University, Sheffield, UK.'}, {'ForeName': 'Shahab', 'Initials': 'S', 'LastName': 'Parvinpour', 'Affiliation': 'Faculty of Physical Education and Sport Sciences, Kharazmi Univerity, Tehran, Iran. Electronic address: Shahabpr@khu.ac.ir.'}, {'ForeName': 'Marzie', 'Initials': 'M', 'LastName': 'Balali', 'Affiliation': 'Faculty of Physical Education and Sport Sciences, Islamic Azad Univerity, Tehran, Iran.'}, {'ForeName': 'Fatemeh Samimi', 'Initials': 'FS', 'LastName': 'Pazhuh', 'Affiliation': 'Faculty of Physical Education and Sport Sciences, Kharazmi Univerity, Tehran, Iran.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Broom', 'Affiliation': 'Centre for Sport, Exercise and Life Sciences, Coventry University, UK.'}]",Gait & posture,['10.1016/j.gaitpost.2021.04.012'] 4168,33863635,The effects of vitamin E on colistin-induced nephrotoxicity in treatment of drug-resistant gram-negative bacterial infections: A randomized clinical trial.,"INTRODUCTION Nephrotoxicity remains a major long-standing concern for colistin, and it is critical to find agents that can prevent it. The present study aims to investigate the effect of vitamin E on the prevention of colistin-induced nephrotoxicity based on its antioxidant and free radical scavenging properties. METHODS A randomized clinical trial was designed for 52 patients taking colistin. These patients were categorized into two groups of equal size, receiving colistin or colistin plus vitamin E (α-Tocopherol). Vitamin E with doses of 400 units was administrated daily either orally or by a nasogastric tube if needed. The incidence of Acute Kidney Injury (AKI) and its duration was recorded based on RIFLE criteria. RESULTS The Incidence of AKI based on RIFLE criteria was 42.3% and 46.2% in intervention and control groups, respectively. The analysis showed no significant difference in the prevalence of AKI for the two groups (P = 0.78). There was no significant difference in the duration of AKI neither (P = 0.83). CONCLUSION Although vitamin E is a powerful biological antioxidant, the effects of Vitamin E prophylaxis on colistin-induced nephrotoxicity was not taken into consideration in this study.",2021,"The Incidence of AKI based on RIFLE criteria was 42.3% and 46.2% in intervention and control groups, respectively.","['52 patients taking colistin', 'drug-resistant gram-negative bacterial infections']","['vitamin E', 'Vitamin E', 'colistin or colistin plus vitamin E (α-Tocopherol']","['Incidence of AKI based on RIFLE criteria', 'incidence of Acute Kidney Injury (AKI) and its duration', 'duration of AKI', 'prevalence of AKI', 'colistin-induced nephrotoxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0009316', 'cui_str': 'Colistin'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0085423', 'cui_str': 'Disease due to Gram-negative bacteria'}]","[{'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0009316', 'cui_str': 'Colistin'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035611', 'cui_str': 'Rifle'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0009316', 'cui_str': 'Colistin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0595916', 'cui_str': 'Toxic nephropathy'}]",,0.19184,"The Incidence of AKI based on RIFLE criteria was 42.3% and 46.2% in intervention and control groups, respectively.","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Samsami', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Minoosh', 'Initials': 'M', 'LastName': 'Shabani', 'Affiliation': 'Department of Infectious Disease and Tropical Medicine, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Infectious Disease and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Hajiesmaeili', 'Affiliation': 'Anesthesia and Critical Care Department, Anesthesiology Research Center, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Tavakoli-Ardakani', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy and Pharmaceutical Sciences Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Hossein', 'Initials': 'SH', 'LastName': 'Ardehali', 'Affiliation': 'Department of Anesthesiology and Critical Care, Faculty of Medicine, Shohadaye - Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Fatemi', 'Affiliation': ""Men's Health and Reproductive Health Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Saghar', 'Initials': 'S', 'LastName': 'Barati', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Moradi', 'Affiliation': 'Student Research Committee, Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Sahraei', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: zahra.sahraei@yahoo.com.'}]",Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy,['10.1016/j.jiac.2021.03.013'] 4169,33863272,"Efficacy and safety of fremanezumab in patients with migraine and inadequate response to prior preventive treatment: subgroup analyses by country of a randomized, placebo-controlled trial.","BACKGROUND The FOCUS study evaluated the efficacy of migraine preventive medications across different countries within the same patient population, particularly for patients with difficult-to-treat migraine. These prespecified subgroup analyses evaluated efficacy by country in the FOCUS study of fremanezumab in adults with episodic migraine or chronic migraine and documented inadequate response to 2 to 4 migraine preventive medication classes. METHODS Overall, 838 participants were enrolled in the FOCUS study, a randomized, double-blind, placebo-controlled, parallel-group, phase 3b study performed at 104 sites. For 12 weeks of double-blind treatment, patients were randomized (1:1:1) to quarterly fremanezumab, monthly fremanezumab, or matched placebo. The primary efficacy endpoint was the mean change from baseline in monthly average migraine days over 12 weeks of double-blind treatment, evaluated by country in these subgroup analyses. RESULTS Of 14 countries contributing data, the Czech Republic (n = 188/838; 22%), the United States (n = 120/838; 14%), and Finland (n = 85/838; 10%) enrolled the most patients. Changes from baseline in monthly average migraine days over 12 weeks were significantly greater with fremanezumab versus placebo for patients in these countries: Czech Republic (least-squares mean difference versus placebo [95% confidence interval]: quarterly fremanezumab, - 1.9 [- 3.25, - 0.47]; P = 0.009; monthly fremanezumab, - 3.0 [- 4.39, - 1.59]; P < 0.001), the United States (quarterly fremanezumab, - 3.7 [- 5.77, - 1.58]; P < 0.001; monthly fremanezumab, - 4.2 [- 6.23, - 2.13]; P < 0.001), and Finland (quarterly fremanezumab, - 3.0 [- 5.32, - 0.63]; P = 0.014; monthly fremanezumab, - 3.9 [- 6.27, - 1.44]; P = 0.002). Results were comparable for the remaining 9 countries, with the least-squares mean difference versus placebo ranging from - 5.6 to - 2.4 with quarterly fremanezumab and from - 5.3 to - 1.5 with monthly fremanezumab. Incidences of serious adverse events and adverse events leading to discontinuation were low and comparable across countries and treatment groups. CONCLUSIONS Monthly and quarterly fremanezumab significantly reduced the monthly average number of migraine days versus placebo regardless of country and continent (North America versus Europe) in migraine patients with documented inadequate response to 2 to 4 migraine preventive medication classes. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03308968 .",2021,"Changes from baseline in monthly average migraine days over 12 weeks were significantly greater with fremanezumab versus placebo for patients in these countries: Czech Republic (least-squares mean difference versus placebo [95% confidence interval]: quarterly fremanezumab, - 1.9 [- 3.25, - 0.47]; P = 0.009; monthly fremanezumab, - 3.0 [- 4.39, - 1.59]; P < 0.001), the United States (quarterly fremanezumab, - 3.7 [- 5.77, - 1.58]; P < 0.001; monthly fremanezumab, - 4.2 [- 6.23, - 2.13]; P < 0.001), and Finland (quarterly fremanezumab, - 3.0 [- 5.32, - 0.63]; P = 0.014; monthly fremanezumab, - 3.9 [- 6.27, - 1.44]; P = 0.002).","['adults with episodic migraine or chronic migraine and documented inadequate response to 2 to 4 migraine preventive medication classes', 'patients with difficult-to-treat migraine', '838 participants were enrolled in the FOCUS study', 'migraine patients with documented inadequate response to 2 to 4 migraine preventive medication classes', 'patients with migraine and inadequate response to prior preventive treatment']","['fremanezumab', 'fremanezumab versus placebo', 'quarterly fremanezumab, monthly fremanezumab, or matched placebo', 'placebo']",['Efficacy and safety'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C4549503', 'cui_str': 'fremanezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",838.0,0.752402,"Changes from baseline in monthly average migraine days over 12 weeks were significantly greater with fremanezumab versus placebo for patients in these countries: Czech Republic (least-squares mean difference versus placebo [95% confidence interval]: quarterly fremanezumab, - 1.9 [- 3.25, - 0.47]; P = 0.009; monthly fremanezumab, - 3.0 [- 4.39, - 1.59]; P < 0.001), the United States (quarterly fremanezumab, - 3.7 [- 5.77, - 1.58]; P < 0.001; monthly fremanezumab, - 4.2 [- 6.23, - 2.13]; P < 0.001), and Finland (quarterly fremanezumab, - 3.0 [- 5.32, - 0.63]; P = 0.014; monthly fremanezumab, - 3.9 [- 6.27, - 1.44]; P = 0.002).","[{'ForeName': 'Egilius L H', 'Initials': 'ELH', 'LastName': 'Spierings', 'Affiliation': 'Boston Headache Institute, Boston PainCare, 85 1st Ave, Waltham, MA, 02451, USA. spierings@medvadis.com.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Kärppä', 'Affiliation': 'Research Unit of Clinical Neuroscience, University of Oulu and Medical Research Center, Oulu University Hospital, P.O. Box 8000, Oulu, FI-90014, Finland.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Ning', 'Affiliation': 'Teva Pharmaceutical Industries, Inc., 145 Brandywine Pkwy, West Chester, PA, 19380, USA.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Cohen', 'Affiliation': 'Teva Pharmaceutical Industries, Inc., 145 Brandywine Pkwy, West Chester, PA, 19380, USA.'}, {'ForeName': 'Verena Ramirez', 'Initials': 'VR', 'LastName': 'Campos', 'Affiliation': 'Teva Pharmaceutical Industries, Inc., 145 Brandywine Pkwy, West Chester, PA, 19380, USA.'}, {'ForeName': 'Ronghua', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Teva Pharmaceutical Industries, Inc., 145 Brandywine Pkwy, West Chester, PA, 19380, USA.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Reuter', 'Affiliation': 'Department of Neurology, Charité Universitätsmedizin, Charitépl. 1, 10117, Berlin, Germany.'}]",The journal of headache and pain,['10.1186/s10194-021-01232-8'] 4170,33863270,Catheter directed thrombolysis and mechanical intervention in deep venous thrombosis: What is the status after the ATTRACT Trial?,"Deep venous thrombosis (DVT) is a major cause of acute and chronic morbidity, mortality, and increased healthcare costs. Endovascular methods of thrombus removal and re-establishing venous patency are increasing in both scope and usage. The most commonly used method of endovascular thrombectomy is catheter directed thrombolysis (CDT). Several studies have shown promise for CDT in alleviating acute symptomatology in acute lower extremity DVT as well as mitigating potential long-term consequences of DVT, such as post-thrombotic syndrome (PTS). The Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) trial is the largest and most comprehensive randomized-controlled trial to date evaluating CDT compared to anticoagulation alone for the treatment of acute symptomatic proximal lower extremity DVT. This review discusses the current status of CDT and adjunctive endovascular interventions for DVT, particularly in the context of the ATTRACT trial.",2021,"Several studies have shown promise for CDT in alleviating acute symptomatology in acute lower extremity DVT as well as mitigating potential long-term consequences of DVT, such as post-thrombotic syndrome (PTS).","['deep venous thrombosis', 'acute symptomatic proximal lower extremity DVT']","['Adjunctive Catheter-Directed Thrombolysis', 'Catheter directed thrombolysis and mechanical intervention']",[],"[{'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]","[{'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.155165,"Several studies have shown promise for CDT in alleviating acute symptomatology in acute lower extremity DVT as well as mitigating potential long-term consequences of DVT, such as post-thrombotic syndrome (PTS).","[{'ForeName': 'Savannah E', 'Initials': 'SE', 'LastName': 'Fletcher', 'Affiliation': 'Division of Interventional Radiology, Department of Radiological Sciences, David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Jasuja', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Leo P', 'Initials': 'LP', 'LastName': 'Lawler', 'Affiliation': 'Division of Interventional Radiology, Department of Radiology, Mater Misericordiae University Hospital, Dublin, Ireland.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Moriarty', 'Affiliation': 'Division of Interventional Radiology, Department of Radiological Sciences, David Geffen School of Medicine at UCLA, Los Angeles, California.'}]",Postgraduate medicine,['10.1080/00325481.2021.1919435'] 4171,33863268,The Use of Clinical Decision Support in Reducing Readmissions for Patients with Heart Failure: A Quasi-experimental Study.,"BACKGROUND Heart failure is a chronic, progressive condition which affects over six million Americans and 26 million people worldwide. Evidence-based guidelines, protocols, and decision-support tools are available to enhance the quality of care delivery but are not implemented consistently. AIMS To examine the effect of clinical decision-making support during patient discharge on 30-day hospital readmission among patients admitted with a primary diagnosis of heart failure and evaluate provider utilization and satisfaction of clinical decision support tool. DESIGN A quasi-experimental study. METHODS An intervention group of hospitalized patients (N=55) with diagnosis of heart failure were provided the intervention over a 3-month period and compared to the pre-intervention comparison group (N=109) of patients who did not receive the intervention within the prior three months. This intervention, an evidence-based discharge checklist and a pocket guide was implemented by an advanced practice nurse to assist health providers with clinical decision making. Descriptive statistics among samples, 30-day readmission rates, and provider utilization and satisfaction were examined. RESULTS Readmission rates slightly decreased (N=109, 9.2% vs. N= 55, 9.1%) in the post-intervention period, but no significant difference. Heterogeneity between the two groups were minimal related to use of specific medications, age, length-of-stay and comorbidities. Descriptively, there was a significant difference the use of diuretics among each group ( p = .002). Discharge checklist was used regularly by 67% of (N=15) providers, and 93% expressed satisfaction with use. CONCLUSION There was no significant reduction in 30-day readmission rates between both groups. However, a slight reduction was noted which indicates the need for further examination into how the use of checklists for clinical decision support can reduce readmissions. A well-designed evidence-based discharge plan remains a critical component of the patient discharge process. Additionally, the advanced practice nurse can promote the utilization of checklists among providers in efforts to improve discharge for patients with heart failure. Advance practice nurses are uniquely qualified to implement evidence-based interventions that promote practice change among health care providers and improve health outcomes. IMPACT STATEMENT Health care providers must explore the use of appropriate discharge checklists for clinical decision-support in efforts reduce readmission for individuals with heart failure.",2021,"Heterogeneity between the two groups were minimal related to use of specific medications, age, length-of-stay and comorbidities.","['individuals with heart failure', 'patients admitted with a primary diagnosis of heart failure and evaluate provider utilization and satisfaction of clinical decision support tool', 'patients with heart failure', 'Patients with Heart Failure', 'hospitalized patients (N=55) with diagnosis of heart failure']",[],"['Readmission rates', '30-day hospital readmission', 'Discharge checklist', '30-day readmission rates', '30-day readmission rates, and provider utilization and satisfaction']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C4042765', 'cui_str': 'Decision Support, Clinical'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",[],"[{'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0587438', 'cui_str': 'Day hospital'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0718959,"Heterogeneity between the two groups were minimal related to use of specific medications, age, length-of-stay and comorbidities.","[{'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Giscombe', 'Affiliation': 'Adjunct Faculty Johns Hopkins University School of Nursing 525 N. Wolfe Street, Baltimore, MD 21205 Email: sgiscom1@jhu.edu.'}, {'ForeName': 'Diana-Lyn', 'Initials': 'DL', 'LastName': 'Baptiste', 'Affiliation': 'Research Associate Department of Nursing Johns Hopkins University School of Nursing 525 N. Wolfe Street, Baltimore, MD 21205 Email: bkoiral1@jhu.edu.'}, {'ForeName': 'Binu', 'Initials': 'B', 'LastName': 'Koirala', 'Affiliation': 'Research Associate Department of Nursing Johns Hopkins University School of Nursing 525 N. Wolfe Street, Baltimore, MD 21205 Email: rasano1@alumni.jh.edu.'}, {'ForeName': 'Reiko', 'Initials': 'R', 'LastName': 'Asano', 'Affiliation': 'Adjunct Faculty Johns Hopkins University School of Nursing 525 N. Wolfe Street, Baltimore, MD 21205 Email: sgiscom1@jhu.edu.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Commodore-Mensah', 'Affiliation': 'Assistant Professor Department of Nursing Johns Hopkins University School of Nursing 525 N. Wolfe Street, Baltimore, MD 21205 Email: ycommod1@jhmi.edu.'}]",Contemporary nurse,['10.1080/10376178.2021.1919161'] 4172,33863260,Socio-economic differences in smoking among adolescents in a school-based smoking intervention: The X:IT II study.,"Aims: Socio-economic inequalities in health behaviour may be influenced by health interventions. We examined whether the X:IT II intervention, aiming at preventing smoking in adolescence, was equally effective among students from different occupational social classes (OSC). Methods: We used data from the multi-component school-based smoking preventive intervention X:IT II, targeting 13- to 15-year-olds in Denmark. The intervention was tested in 46 schools with 2307 eligible students at baseline (response rate=86.6%) and had three main intervention components: smoke-free school time, smoke-free curriculum and parental involvement. We used a difference-in-difference design and estimated the change in current smoking after the first year of implementation in high versus low OSC. Analyses were based on available cases ( N =1190) and imputation of missing data at follow-up ( N =1967). Results: We found that 1% of the students from high OSC and 4.9% from low OSC were smokers at baseline (imputed data), and 8.2% of the students from high OSC and 12.2% from low OSC were smokers at follow-up. Difference-in-difference estimates were close to zero, indicating no differential trajectory. Conclusions: As intended, the X:IT II intervention, designed to apply equally to students from all socio-economic groups, did not seem to create different trajectories in current smoking among adolescents in high and low socio-economic groups. To diminish social inequality in health, future studies should carefully consider the ability to affect all socio-economic groups equally, or even to appeal mainly to participants from lower socio-economic groups, as they are often the ones most in need of intervention.",2021,"We found that 1% of the students from high OSC and 4.9% from low OSC were smokers at baseline (imputed data), and 8.2% of the students from high OSC and 12.2% from low OSC were smokers at follow-up.","['46 schools with 2307 eligible students at baseline (response rate=86.6%) and had three main intervention components: smoke-free school time, smoke-free curriculum and parental involvement', 'adolescents in high and low socio-economic groups', 'students from different occupational social classes (OSC']",[],[],"[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0037402', 'cui_str': 'Social Class'}]",[],[],2307.0,0.027731,"We found that 1% of the students from high OSC and 4.9% from low OSC were smokers at baseline (imputed data), and 8.2% of the students from high OSC and 12.2% from low OSC were smokers at follow-up.","[{'ForeName': 'Lotus S', 'Initials': 'LS', 'LastName': 'Bast', 'Affiliation': 'University of Southern Denmark, Denmark.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Lund', 'Affiliation': 'University of Southern Denmark, Denmark.'}, {'ForeName': 'Stine G', 'Initials': 'SG', 'LastName': 'LauemØller', 'Affiliation': 'University of Southern Denmark, Denmark.'}, {'ForeName': 'Simone G', 'Initials': 'SG', 'LastName': 'Kjeld', 'Affiliation': 'University of Southern Denmark, Denmark.'}, {'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Due', 'Affiliation': 'University of Southern Denmark, Denmark.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Andersen', 'Affiliation': 'Steno Diabetes Centre, Denmark.'}]",Scandinavian journal of public health,['10.1177/14034948211007683'] 4173,33863242,Strategies for facilitating the delivery of cluster randomized trials in hospitals: A study informed by the CFIR-ERIC matching tool.,"BACKGROUND Recruitment and engagement of clusters in a cluster randomized controlled trial can sometimes prove challenging. Identification of successful or unsuccessful strategies may be beneficial in guiding future researchers in conducting their cluster randomized controlled trial. This study aimed to identify strategies that could be used to facilitate the delivery of cluster randomized controlled trials in hospitals. METHODS The study employed the Consolidated Framework for Implementation Research-Expert Recommendations for Implementing Change matching tool. The barriers and enablers to cluster randomized controlled trial conduct identified in our previously conducted studies served as a means of determinant identification for the conduct of cluster randomized controlled trials. These determinants were mapped to Consolidated Framework for Implementation Research constructs and then matched to Expert Recommendations for Implementing Change compilation strategies using the Consolidated Framework for Implementation Research-Expert Recommendations for Implementing Change matching tool. RESULTS The Expert Recommendations for Implementing Change strategies matched to at least one determinant Consolidated Framework for Implementation Research construct were as follows: (1) 'Identify and prepare champions', (2) 'Conduct local needs assessment', (3) 'Conduct educational meetings', (4) 'Inform local opinion leaders', (5) 'Build a coalition', (6) 'Promote adaptability', (7) 'Develop a formal implementation blueprint', (8) 'Involve patients/consumers and family members', (9) 'Obtain and use patients/consumers and family feedback', (10) 'Develop educational materials', (11) 'Promote network weaving', (12) 'Distribute educational materials', (13) 'Access new funding' and (14) 'Develop academic partnerships'. CONCLUSION This study was intended as a step in the research agenda aimed at facilitating cluster randomized controlled trial delivery in hospitals and can act as a resource for future researchers when planning their cluster randomized controlled trial, with the expectation that the strategies identified here will be tailored to each context.",2021,"This study was intended as a step in the research agenda aimed at facilitating cluster randomized controlled trial delivery in hospitals and can act as a resource for future researchers when planning their cluster randomized controlled trial, with the expectation that the strategies identified here will be tailored to each context.","['hospitals', ""patients/consumers and family members', (9) 'Obtain and use patients/consumers and family feedback', (10) ""]",[],[],"[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",[],[],,0.236661,"This study was intended as a step in the research agenda aimed at facilitating cluster randomized controlled trial delivery in hospitals and can act as a resource for future researchers when planning their cluster randomized controlled trial, with the expectation that the strategies identified here will be tailored to each context.","[{'ForeName': 'Arielle', 'Initials': 'A', 'LastName': 'Weir', 'Affiliation': 'School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Presseau', 'Affiliation': 'School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kitto', 'Affiliation': 'Department of Innovation in Medical Education, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Colman', 'Affiliation': 'School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Hatcher', 'Affiliation': 'School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada.'}]","Clinical trials (London, England)",['10.1177/17407745211001504'] 4174,33862351,Self-preference music for gagging patient: Effect on physiology and oral health-related quality of life during dental impression.,"BACKGROUND Gagging condition is among factors contributing to avoidance behavior to seek the dental treatment, and rigorous management is still under investigation. This study aims to explore the effect of listening to the self-preference music in reducing the gagging condition during dental impression procedure towards gagging patient. Physiology and psychological impact to the procedure with and without musical intervention are investigated. METHOD AND MATERIAL A group of twenty-five patients that will undergo impression procedure was randomly selected. Self-reported Gagging Problem Assessment (GPA-pa-SF) questionnaires was then administered to determine the severity of gagging. Maxillary impression was taken twice within the same patient in two different time intervals (1st without any intervention and 2nd with musical intervention). During both procedures, the pulse rate/minutes (BPM) and arterial oxygen saturation of haemoglobin (SpO 2 %) were recorded and psychometric assessment was evaluated through the Oral Health Impact Profile (OHIP-14). RESULT Mean value of BPM was significantly reduced with music (p < 0.05) while SpO 2 was considerably has positive effect although was found no significant. The OHIP 14 demonstrated that functional limitation and psychological disability were the most affected before the intervention. Overall, musical stimuli had a significant effect on stress reduction in both physiological (p < 0.05) and psychological (p < 0.05) outcomes except for social disability and handicap items. CONCLUSION Listening to self-preference music during impression taking had improved physiology and psychology of gagging patients thus, can be attributed to the better dental management.",2021,"Overall, musical stimuli had a significant effect on stress reduction in both physiological (p < 0.05) and psychological (p < 0.05) outcomes except for social disability and handicap items. ","['gagging patient', 'dental impression procedure towards gagging patient', 'A group of twenty-five patients that will undergo impression procedure was randomly selected']","['Self-reported Gagging Problem Assessment (GPA-pa-SF) questionnaires', 'listening to the self-preference music']","['functional limitation and psychological disability', 'Mean value of BPM', 'Oral Health Impact Profile (OHIP-14', 'pulse rate/minutes (BPM) and arterial oxygen saturation of haemoglobin', 'stress reduction', 'social disability and handicap items']","[{'cui': 'C0016927', 'cui_str': 'Gagging'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011375', 'cui_str': 'Dental impression procedure'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0016927', 'cui_str': 'Gagging'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0017955', 'cui_str': 'Glycophorin A'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}]",25.0,0.00521626,"Overall, musical stimuli had a significant effect on stress reduction in both physiological (p < 0.05) and psychological (p < 0.05) outcomes except for social disability and handicap items. ","[{'ForeName': 'Nor Wati Nur Atikah', 'Initials': 'NWNA', 'LastName': 'Mustafa', 'Affiliation': 'Centre of Restorative Dentistry Studies, Faculty of Dentistry, Universiti Teknologi MARA (UiTM), 47000, Sungai Buloh, Selangor, Malaysia. Electronic address: norwati_atikah@uitm.edu.my.'}, {'ForeName': 'Nur Humaira', 'Initials': 'NH', 'LastName': 'Ishak', 'Affiliation': 'Faculty of Dentistry, Universiti Teknologi MARA (UiTM), 47000, Sungai Buloh, Selangor, Malaysia. Electronic address: nhumaira97@gmail.com.'}, {'ForeName': 'Nur Athirah', 'Initials': 'NA', 'LastName': 'Mohd Rosli', 'Affiliation': 'Faculty of Dentistry, Universiti Teknologi MARA (UiTM), 47000, Sungai Buloh, Selangor, Malaysia. Electronic address: athirahrosli277@yahoo.com.'}, {'ForeName': 'Nik Rahayyu', 'Initials': 'NR', 'LastName': 'Nik Zulkifeli', 'Affiliation': 'Centre of Comprehensive Care Studies, Faculty of Dentistry, Universiti Teknologi MARA (UiTM), 47000, Sungai Buloh, Selangor, Malaysia. Electronic address: nikrahayyu7877@uitm.edu.my.'}, {'ForeName': 'Aiemeeza', 'Initials': 'A', 'LastName': 'Rajali', 'Affiliation': 'Centre of Restorative Dentistry Studies, Faculty of Dentistry, Universiti Teknologi MARA (UiTM), 47000, Sungai Buloh, Selangor, Malaysia. Electronic address: aiemeeza7738@uitm.edu.my.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101392'] 4175,33862350,Punica granatum peel extract as adjunct irrigation to nonsurgical treatment of chronic gingivitis.,"Pomegranate is one of the most universally studied medicinal plants for its ethnomedical history, with several studies presenting the positive outcome of its use or its extracts in managing inflammation. The objective of the present trial was to investigate the efficiency of the traditionally used 5% of pomegranate peel extract in treating gingival inflammation. Herein, 34 chronic gingivitis patients were randomized in a 1:1 ratio for four weeks in a controlled, double-blind clinical trial to evaluate the effect of the adjunctive use of a pulsating jet irrigator containing 5% pomegranate peel extract solution to nonsurgical periodontal therapy against a placebo in managing these patients' condition. No adverse reactions had been reported, and within the limits of this study, it may be concluded that pomegranate peel extract can serve as a promising alternative in managing chronic gingivitis. This trial is registered on the German clinical trials register (DRKS-ID: DRKS00010602).",2021,"No adverse reactions had been reported, and within the limits of this study, it may be concluded that pomegranate peel extract can serve as a promising alternative in managing chronic gingivitis.","['34 chronic gingivitis patients', 'chronic gingivitis']","['Punica granatum peel extract', 'pomegranate peel extract', 'pulsating jet irrigator containing 5% pomegranate peel extract solution to nonsurgical periodontal therapy against a placebo']",['gingival inflammation'],"[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1509685', 'cui_str': 'POMEGRANATE FRUIT EXTRACT'}, {'cui': 'C0237849', 'cui_str': 'Peeling of skin'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0439606', 'cui_str': 'Pulsatile'}, {'cui': 'C0336862', 'cui_str': 'Jet airplane'}, {'cui': 'C0335463', 'cui_str': 'Irrigator'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017574', 'cui_str': 'Gingivitis'}]",34.0,0.118198,"No adverse reactions had been reported, and within the limits of this study, it may be concluded that pomegranate peel extract can serve as a promising alternative in managing chronic gingivitis.","[{'ForeName': 'Eiba G', 'Initials': 'EG', 'LastName': 'Eltay', 'Affiliation': 'Council of Periodontology and Dental Public Health, Sudan Medical Specialization Board, Khartoum, Sudan. Electronic address: eiba.g.eltay@gmail.com.'}, {'ForeName': 'Bakri Gobara', 'Initials': 'BG', 'LastName': 'Gismalla', 'Affiliation': 'Associate Professor of Restorative Dentistry, Faculty of Dentistry, University of Khartoum, Khartoum, Sudan.'}, {'ForeName': 'Maowia M', 'Initials': 'MM', 'LastName': 'Mukhtar', 'Affiliation': 'Bioscience Research Institute, Ibn Sina University, Khartoum, Sudan.'}, {'ForeName': 'Mona O A', 'Initials': 'MOA', 'LastName': 'Awadelkarim', 'Affiliation': 'Bioscience Research Institute, Ibn Sina University, Khartoum, Sudan.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101383'] 4176,33862313,Short and long term effects of Nabiximols on balance and walking assessed by 3D-gait analysis in people with Multiple Sclerosis and spasticity.,"BACKGROUND Spasticity in people with Multiple Sclerosis (pwMS) is one of the most disabling symptoms on walking ability and balance. Among the systemic antispastic drugs, Nabiximols showed a good tolerability, safety profile and relevant efficacy. A few studies assessed long-term effects of this drug through clinical scales and instrumental tools, but no study investigated short-term effects. The aim of our study is to quantitatively evaluate the immediate effects of Nabiximols on walking and balance and their maintenance after 4 weeks in pwMS and spasticity. METHODS pwMS were enrolled and randomized in 2 treatment groups: Sativex (SG) and control (CG) group. All patients were assessed at T0 (before the first Sativex puff), T1(after 45 minutes) and T2 (after 4 weeks of treatment) using clinical scales and 3d-Gait Analysis . Then, the patients treated with Sativex, were divided into 5 subgroups according to Numeric Rating Scale for spasticity (NRSs) and Berg Balance Score (BBS) response: NRSs responder[1] and non-[2]; BBS responders[3] and non-[4]; NRSs-BBS responders[5]. RESULTS 32 pwMS (22 SG, 10 CG) were recruited. Significant improvements were found between T0 and T1 in SG compared to CG in a few clinical and kinematic parameters. Larger significant differences were found for NRSs and BBS responders' groups versus CG. Eventually, no significant differences were found comparing the results between T1 and T2, suggesting the persistence of the improvements emerged at T1. CONCLUSION These results quantitatively demonstrated a short time effect of Nabiximols on balance and walking of pwMS, which is mantained after 4 weeks. Patients identified as responder by combination of NRSs and BBS showed the best efficacy. These findings may suggest how to early select the real responders in order to improve the adherence and cost-effectiveness of the therapy.",2021,"Eventually, no significant differences were found comparing the results between T1 and T2, suggesting the persistence of the improvements emerged at T1. ","['32', 'pwMS were enrolled and randomized in 2 treatment groups', 'people with Multiple Sclerosis and spasticity', 'people with Multiple Sclerosis (pwMS']","['Nabiximols', 'Sativex (SG) and control (CG']","['Numeric Rating Scale for spasticity (NRSs) and Berg Balance Score (BBS) response: NRSs responder[1] and non-[2]; BBS responders[3] and non-[4]; NRSs-BBS responders[5', 'adherence and cost-effectiveness', 'good tolerability, safety profile and relevant efficacy']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}]","[{'cui': 'C2347556', 'cui_str': 'nabiximols'}, {'cui': 'C1614968', 'cui_str': 'Sativex'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.018592,"Eventually, no significant differences were found comparing the results between T1 and T2, suggesting the persistence of the improvements emerged at T1. ","[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'De Blasiis', 'Affiliation': 'University of Campania ""Luigi Vanvitelli"", Department of Advanced Medical and Surgical Sciences, 2nd Division of Neurology, Naples, Italy.. Electronic address: paolodeblasiis@gmail.com.'}, {'ForeName': 'Maria Francesca', 'Initials': 'MF', 'LastName': 'Siani', 'Affiliation': 'University of Campania ""Luigi Vanvitelli"", Department of Advanced Medical and Surgical Sciences, 2nd Division of Neurology, Naples, Italy.'}, {'ForeName': 'Allegra', 'Initials': 'A', 'LastName': 'Fullin', 'Affiliation': 'University of Campania ""Luigi Vanvitelli"", Department of Advanced Medical and Surgical Sciences, 2nd Division of Neurology, Naples, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Sansone', 'Affiliation': 'University ""Federico II"" of Naples, Department of Electrical Engineering and Information Technology, Naples, Italy.'}, {'ForeName': 'Mariarosa Anna Beatrice', 'Initials': 'MAB', 'LastName': 'Melone', 'Affiliation': 'University of Campania ""Luigi Vanvitelli"", Department of Advanced Medical and Surgical Sciences, 2nd Division of Neurology, Naples, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Sampaolo', 'Affiliation': 'University of Campania ""Luigi Vanvitelli"", Department of Advanced Medical and Surgical Sciences, 2nd Division of Neurology, Naples, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Signoriello', 'Affiliation': 'University of Campania ""Luigi Vanvitelli"", Department of Advanced Medical and Surgical Sciences, 2nd Division of Neurology, Naples, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Lus', 'Affiliation': 'University of Campania ""Luigi Vanvitelli"", Department of Advanced Medical and Surgical Sciences, 2nd Division of Neurology, Naples, Italy.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2021.102805'] 4177,33862308,Effects from loaded walking with polyurethane and styrene-butadiene rubber midsole military boots on kinematics and external forces: A statistical parametric mapping analysis.,"This study compared ground reaction forces (GRF) and lower limb two-dimensional (2D) kinematic waveforms, with and without load carriage, in military personnel walking in two different types of boots. Data were measured in 24-soldiers walking on a 10-m walkway under four randomized crossover trials: wearing two military boots (styrene-butadiene rubber midsole - SBR - 63 Shore A; and polyurethane midsole - PU - 48 Shore A); with and without a 15-kg backpack. GRF traditional parameters were evaluated by two-way ANOVAs. GRF and kinematic waveforms were assessed using a statistical parametric mapping (SPM) method (two-way ANOVA). No interaction effects were observed between footwear and load. GRF at the beginning of stance was lower while wearing the SBR boot condition compared to the PU boot condition. Load carriage increased trunk, hip, and knee flexion. The analyzed military boots did not affect movement patterns during loaded walking and the military boot with SBR midsole material reduced impact to a greater extent. The study demonstrated that the design and materials (e.g., midsole material and thickness) used in boot manufacturing can influence military boot performance.",2021,The analyzed military boots did not affect movement patterns during loaded walking and the military boot with SBR midsole material reduced impact to a greater extent.,['military personnel walking in two different types of boots'],"['wearing two military boots (styrene-butadiene rubber midsole - SBR - 63 Shore A; and polyurethane midsole - PU - 48 Shore A); with and without a 15-kg backpack', 'loaded walking with polyurethane and styrene-butadiene rubber midsole military boots', 'ground reaction forces (GRF) and lower limb two-dimensional (2D) kinematic waveforms']","['GRF and kinematic waveforms', 'kinematics and external forces', 'Load carriage increased trunk, hip, and knee flexion']","[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0331794', 'cui_str': 'Boots'}]","[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0331794', 'cui_str': 'Boots'}, {'cui': 'C0084656', 'cui_str': 'styrene-butadiene rubber'}, {'cui': 'C0032616', 'cui_str': 'Polyisocyanate'}, {'cui': 'C4705431', 'cui_str': 'PU-48'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0450448', 'cui_str': 'Waveforms'}]","[{'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0450448', 'cui_str': 'Waveforms'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}]",2.0,0.0230892,The analyzed military boots did not affect movement patterns during loaded walking and the military boot with SBR midsole material reduced impact to a greater extent.,"[{'ForeName': 'Adriane', 'Initials': 'A', 'LastName': 'Mara de Souza Muniz', 'Affiliation': 'Escola de Educação Física do Exército (EsEFEx), Brazilian Army, Rio de Janeiro, RJ, Brazil. Electronic address: adriane_muniz@yahoo.com.br.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Sizenando', 'Affiliation': 'Escola de Educação Física do Exército (EsEFEx), Brazilian Army, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Lobo', 'Affiliation': 'Escola de Educação Física do Exército (EsEFEx), Brazilian Army, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Eduardo Borba', 'Initials': 'EB', 'LastName': 'Neves', 'Affiliation': 'Instituto de Pesquisa da Capacitação Física do Exército (IPCFEx), Brazilian Army, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Gonçalves', 'Affiliation': 'Escola de Educação Física do Exército (EsEFEx), Brazilian Army, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Runer', 'Initials': 'R', 'LastName': 'Marson', 'Affiliation': 'Instituto de Pesquisa da Capacitação Física do Exército (IPCFEx), Brazilian Army, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Rudnei', 'Initials': 'R', 'LastName': 'Palhano', 'Affiliation': 'Instituto Brasileiro de Tecnologia do Couro, Calçado e Artefatos (IBTEc), Novo Hamburgo, RS, Brazil.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Menegaldo', 'Affiliation': 'Programa de Engenharia Biomédica, PEB/COPPE, Universidade Federal do Rio de Janeiro (UFRJ), RJ, Brazil.'}, {'ForeName': 'Rodrigo Rico', 'Initials': 'RR', 'LastName': 'Bini', 'Affiliation': 'La Trobe Rural Health School, La Trobe University, Flora Hill Campus, Bendigo, Victoria, 3550, Australia.'}]",Applied ergonomics,['10.1016/j.apergo.2021.103429'] 4178,33861742,"Effects of engaging communities in decision-making and action through traditional and religious leaders on vaccination coverage in Cross River State, Nigeria: A cluster-randomised control trial.","BACKGROUND Vaccination coverage levels fall short of the Global Vaccine and Action Plan 90% target in low- and middle- income countries (LMICs). Having identified traditional and religious leaders (TRLs) as potential public health change agents, this study aimed at assessing the effect of training them to support routine immunisation for the purpose of improving uptake of childhood vaccines in Cross River State, Nigeria. METHODS A cluster-randomised controlled study was conducted between 2016 and 2019. Of the 18 Local Government Areas (LGA) in Cross River State, eight (four urban and four rural LGAs) were randomized into the intervention and control study arms. A multi-component intervention involving the training of traditional and religious leaders was implemented in the four intervention LGAs. Baseline, midline and endline surveys collected information on children aged 0-23 months. The effect of the intervention on outcomes including the proportion fully up-to-date with vaccination, timely vaccination for pentavalent and measles vaccines, and pentavalent 1-3 dropout rates were estimated using logistic regression models using random effects to account for the clustered data. RESULTS A total of 2598 children at baseline, 2570 at midline, and 2550 at endline were included. The intervention was effective in increasing the proportion with at least one vaccine (OR 12.13 95% CI 6.03-24.41p<0.001). However, there was no evidence of an impact on the proportion of children up-to-date with vaccination (p = 0.69). It was effective in improving timeliness of Pentavalent 3 (OR 1.55; 95% CI: 1.14, 2.12; p = 0.005) and Measles (OR 2.81; 96% CI: 1.93-4.1; p<0.001) vaccination. The odds of completing Pentavalent vaccination increased (OR = 1.66 95% CI: 1.08,2.55). CONCLUSION Informal training to enhance the traditional and religious leaders' knowledge of vaccination and their leadership role can empower them to be good influencers for childhood vaccination. They constitute untapped resources in the community to boost routine immunisation. Pan African Clinical Trial Registry (PACTR) PACTR202008784222254.",2021,"The odds of completing Pentavalent vaccination increased (OR = 1.66 95% CI: 1.08,2.55). ","['2598 children at baseline, 2570 at midline, and 2550 at endline were included', 'A cluster-randomised controlled study was conducted between 2016 and 2019', '18 Local Government Areas (LGA) in Cross River State, eight (four urban and four rural LGAs', 'children aged 0-23 months', 'Cross River State, Nigeria']",[],['odds of completing Pentavalent vaccination'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0026788', 'cui_str': 'Government, Local'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0337050', 'cui_str': 'River'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}]",[],"[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",2598.0,0.064812,"The odds of completing Pentavalent vaccination increased (OR = 1.66 95% CI: 1.08,2.55). ","[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Oyo-Ita', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, College of Medical Sciences, University of Calabar, Calabar, Cross River State, Nigeria.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Bosch-Capblanch', 'Affiliation': 'University of Basel, Basel, Switzerland.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Ross', 'Affiliation': 'University of Basel, Basel, Switzerland.'}, {'ForeName': 'Afiong', 'Initials': 'A', 'LastName': 'Oku', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, College of Medical Sciences, University of Calabar, Calabar, Cross River State, Nigeria.'}, {'ForeName': 'Ekpereonne', 'Initials': 'E', 'LastName': 'Esu', 'Affiliation': 'Effective Health Care Alliance Programme, Institute of Tropical Disease, Research and Prevention, University of Calabar Teaching Hospital, Calabar, Cross River State, Nigeria.'}, {'ForeName': 'Soter', 'Initials': 'S', 'LastName': 'Ameh', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, College of Medical Sciences, University of Calabar, Calabar, Cross River State, Nigeria.'}, {'ForeName': 'Olabisi', 'Initials': 'O', 'LastName': 'Oduwole', 'Affiliation': 'Effective Health Care Alliance Programme, Institute of Tropical Disease, Research and Prevention, University of Calabar Teaching Hospital, Calabar, Cross River State, Nigeria.'}, {'ForeName': 'Dachi', 'Initials': 'D', 'LastName': 'Arikpo', 'Affiliation': 'Effective Health Care Alliance Programme, Institute of Tropical Disease, Research and Prevention, University of Calabar Teaching Hospital, Calabar, Cross River State, Nigeria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Meremikwu', 'Affiliation': 'Effective Health Care Alliance Programme, Institute of Tropical Disease, Research and Prevention, University of Calabar Teaching Hospital, Calabar, Cross River State, Nigeria.'}]",PloS one,['10.1371/journal.pone.0248236'] 4179,33861741,"Control of scabies in a tribal community using mass screening and treatment with oral ivermectin -A cluster randomized controlled trial in Gadchiroli, India.","BACKGROUND Scabies is often endemic in tribal communities and difficult to control. We assessed the efficacy of a community-based intervention using mass screening and treatment with oral ivermectin in controlling scabies. METHODS/ FINDINGS In this cluster randomised controlled trial, 12 villages were randomly selected from a cluster of 42 tribal villages in Gadchiroli district. In these villages, trained community health workers (CHWs) conducted mass screening for scabies. The diagnosis was confirmed by a physician. Six villages each were randomly allocated to the intervention and usual care arm. In the intervention arm (population 1184) CHWs provided directly observed oral ivermectin to scabies cases and their household contacts. In the usual care arm (population 1567) scabies cases were referred to the nearest clinic for topical treatment as per the standard practice. The primary outcome was prevalence of scabies two months after the treatment. Secondary outcomes were prevalence of scabies after twelve months of treatment and prevalence of impetigo after two and twelve months of treatment. Outcomes were measured by the team in a similar way as the baseline. The trial was registered with the clinical trial registry of India, number CTRI/2017/01/007704. In the baseline, 2 months and 12 months assessments 92.4%, 96% and 94% of the eligible individuals were screened in intervention villages and 91.4%, 91.3% and 95% in the usual care villages. The prevalence of scabies in the intervention and usual care arm was 8.4% vs 8.1% at the baseline, 2.8% vs 8.8% at two months [adjusted relative risk (ARR) 0.21, 95% CI 0.11-0.38] and 7.3% vs 14.1% (ARR 0.49, 95% CI 0.25-0.98) at twelve months The prevalence of impetigo in the intervention and usual care arm was 1.7% vs 0.6% at baseline, 0.6% vs 1% at two months (ARR 0.55, 95% CI 0.22-1.37) and 0.3% vs 0.7% at 12 months (ARR 0.42, 95% CI 0.06-2.74). Adverse effects due to ivermectin occurred in 12.1% of patients and were mild. CONCLUSIONS Mass screening and treatment in the community with oral ivermectin delivered by the CHWs is superior to mass screening followed by usual care involving referral to clinic for topical treatment in controlling scabies in this tribal community in Gadchiroli.",2021,"The prevalence of scabies in the intervention and usual care arm was 8.4% vs 8.1% at the baseline, 2.8% vs 8.8% at two months [adjusted relative risk (ARR) 0.21, 95% CI 0.11-0.38] and 7.3% vs 14.1% (ARR 0.49, 95% CI 0.25-0.98) at twelve months","['12 villages were randomly selected from a cluster of 42 tribal villages in Gadchiroli district', 'Six villages each']","['community-based intervention using mass screening and treatment with oral ivermectin', 'ivermectin']","['prevalence of scabies', 'prevalence of impetigo', 'prevalence of scabies after twelve months of treatment and prevalence of impetigo', 'Adverse effects']","[{'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0024870', 'cui_str': 'Mass Screening'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0022322', 'cui_str': 'Ivermectin'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036262', 'cui_str': 'Infestation by Sarcoptes scabiei var hominis'}, {'cui': 'C0021099', 'cui_str': 'Impetigo'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",12.0,0.183876,"The prevalence of scabies in the intervention and usual care arm was 8.4% vs 8.1% at the baseline, 2.8% vs 8.8% at two months [adjusted relative risk (ARR) 0.21, 95% CI 0.11-0.38] and 7.3% vs 14.1% (ARR 0.49, 95% CI 0.25-0.98) at twelve months","[{'ForeName': 'Priyamadhaba', 'Initials': 'P', 'LastName': 'Behera', 'Affiliation': 'Society for Education Action and Research in Community Health (SEARCH), Gadchiroli, Maharashtra, India.'}, {'ForeName': 'Hrishikesh', 'Initials': 'H', 'LastName': 'Munshi', 'Affiliation': 'Society for Education Action and Research in Community Health (SEARCH), Gadchiroli, Maharashtra, India.'}, {'ForeName': 'Yogeshwar', 'Initials': 'Y', 'LastName': 'Kalkonde', 'Affiliation': 'Society for Education Action and Research in Community Health (SEARCH), Gadchiroli, Maharashtra, India.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Deshmukh', 'Affiliation': 'Society for Education Action and Research in Community Health (SEARCH), Gadchiroli, Maharashtra, India.'}, {'ForeName': 'Abhay', 'Initials': 'A', 'LastName': 'Bang', 'Affiliation': 'Society for Education Action and Research in Community Health (SEARCH), Gadchiroli, Maharashtra, India.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0009330'] 4180,33861738,"No association of genetic variants in TLR4, TNF-α, IL10, IFN-γ, and IL37 in cytomegalovirus-positive renal allograft recipients with active CMV infection-Subanalysis of the prospective randomised VIPP study.","BACKGROUND Cytomegalovirus (CMV) infection is amongst the most important factors complicating solid organ transplantation. In a large prospective randomized clinical trial, valganciclovir prophylaxis reduced the occurrence of CMV infection and disease compared with preemptive therapy in CMV-positive renal allograft recipients (VIPP study; NCT00372229). Here, we present a subanalysis of the VIPP study, investigating single nucleotide polymorphisms (SNPs) in immune-response-related genes and their association with active CMV infection, CMV disease, graft loss or death, rejection, infections, and leukopenia. METHODS Based on literature research ten SNPs were analyzed for TLR4, three for IFN-γ, six for IL10, nine for IL37, and two for TNF-α. An asymptotic independence test (Cochran-Armitage trend test) was used to examine associations between SNPs and the occurrence of CMV infection or other negative outcomes. Statistical significance was defined as p<0.05 and Bonferroni correction for multiple testing was performed. RESULTS SNPs were analyzed on 116 blood samples. No associations were found between the analyzed SNPs and the occurrence of CMV infection, rejection and leukopenia in all patients. For IL37 rs2723186, an association with CMV disease (p = 0.0499), for IL10 rs1800872, with graft loss or death (p = 0.0207) and for IL10 rs3024496, with infections (p = 0.0258) was observed in all patients, however did not hold true after correction for multiple testing. CONCLUSION The study did not reveal significant associations between the analyzed SNPs and the occurrence of negative outcomes in CMV-positive renal transplant recipients after correction for multiple testing. The results of this association analysis may be of use in guiding future research efforts.",2021,"For IL37 rs2723186, an association with CMV disease (p = 0.0499), for IL10 rs1800872, with graft loss or death (p = 0.0207) and for IL10 rs3024496, with infections (p = 0.0258) was observed in all patients, however did not hold true after correction for multiple testing. ",[],"['TNF-α', 'valganciclovir prophylaxis']","['occurrence of CMV infection and disease', 'graft loss or death', 'active CMV infection, CMV disease, graft loss or death, rejection, infections, and leukopenia', 'occurrence of CMV infection, rejection and leukopenia']",[],"[{'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0909381', 'cui_str': 'valganciclovir'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0877042', 'cui_str': 'Graft loss'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}]",,0.0333144,"For IL37 rs2723186, an association with CMV disease (p = 0.0499), for IL10 rs1800872, with graft loss or death (p = 0.0207) and for IL10 rs3024496, with infections (p = 0.0258) was observed in all patients, however did not hold true after correction for multiple testing. ","[{'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Mazzola', 'Affiliation': 'Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology (IKP), Stuttgart, Germany.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Schaeffeler', 'Affiliation': 'Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology (IKP), Stuttgart, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Witzke', 'Affiliation': 'Department of Infectious Diseases, West German Centre of Infectious Diseases, Universitätsmedizin Essen, University Duisburg-Essen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Nitschke', 'Affiliation': 'Transplantation Center, Medical Clinic I, University Hospital Schleswig-Holstein, Luebeck, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Kliem', 'Affiliation': 'Department of Internal Medicine and Nephrology, Nephrology Center of Lower Saxony, Klinikum Hann. Muenden, Hann. Muenden, Germany.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Zortel', 'Affiliation': 'Roche Pharma AG, Grenzach-Wyhlen, Germany.'}, {'ForeName': 'Eva-Maria', 'Initials': 'EM', 'LastName': 'Wagner', 'Affiliation': 'Roche Pharma AG, Grenzach-Wyhlen, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Schwab', 'Affiliation': 'Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology (IKP), Stuttgart, Germany.'}, {'ForeName': 'Ingeborg A', 'Initials': 'IA', 'LastName': 'Hauser', 'Affiliation': 'Department of Nephrology, University Clinic Frankfurt, Goethe University Frankfurt, Frankfurt, Germany.'}]",PloS one,['10.1371/journal.pone.0246118'] 4181,33861704,Evaluating User and Machine Learning in Short-and Long-term Pattern Recognition-based Myoelectric Control.,"Proper training is essential to achieve reliable pattern recognition (PR) based myoelectric control. The amount of training is commonly determined by experience. The purpose of this study is to provide an offline validation method that makes the offline performance transferable to online control and find the proper amount of training that achieves good online performance. In the offline experiment, eight able-bodied subjects and three amputees participated in a ten-day training. Repeatability index (RI) and classification error (CE) were used to evaluate user learning and machine learning, respectively. The performance of cross-validation (CV) and time serial related validation (TSV) was compared. Learning curves were established with different training trials by TSV. In the online experiment, sixteen able-bodied subjects were randomly divided into two groups with one- or five-trial training, respectively, followed by participating in the test with and without classifier-output feedback. The correlation between offline and online tests was analyzed. Results indicated that five-trial training was proper to train the user and the classifier. The long-term retention of skills could not shorten the learning process. The correlation between CEs of TSV and the online test was strong (r = 0.87) with five-trial training, while the correlation between CEs of CV and the online test was weak (r = 0.30). Outcomes demonstrate that offline performance evaluated by TSV is transferable to online performance and the learning process can guide the user to achieve good online myoelectric control with minimum training.",2021,Outcomes demonstrate that offline performance evaluated by TSV is transferable to online performance and the learning process can guide the user to achieve good online myoelectric control with minimum training.,['sixteen able-bodied subjects'],[],"['Repeatability index (RI) and classification error (CE', 'performance of cross-validation (CV) and time serial related validation (TSV']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",[],"[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}]",,0.00738685,Outcomes demonstrate that offline performance evaluated by TSV is transferable to online performance and the learning process can guide the user to achieve good online myoelectric control with minimum training.,"[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Lv', 'Affiliation': ''}, {'ForeName': 'Guohong', 'Initials': 'G', 'LastName': 'Chai', 'Affiliation': ''}, {'ForeName': 'Xinjun', 'Initials': 'X', 'LastName': 'Sheng', 'Affiliation': ''}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Ding', 'Affiliation': ''}, {'ForeName': 'Xiangyang', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': ''}]",IEEE transactions on neural systems and rehabilitation engineering : a publication of the IEEE Engineering in Medicine and Biology Society,['10.1109/TNSRE.2021.3073751'] 4182,33861679,Cross-neutralization capacity of immune serum from different dosage of Sabin inactivated poliovirus vaccine immunization against multiple individual polioviruses.,"OBJECTIVES To study the neutralizing capacity of Sabin strain-inactivated poliovirus vaccine (sIPV) immune serum against different strains of poliovirus. RESEARCH DESIGN AND METHODS A neutralization assay against ten individual virus strains was performed on serum collected from 250 infant participants, who randomly received three doses of investigational sIPV with high, medium, and low antigen content, conventional inactivated poliovirus vaccine (cIPV), and control sIPV, at 0, 1, and 2 months. This study was conducted between July 20, 2019, and January 10, 2020, and the study location was Pizhou city, Jiangsu province, China. RESULTS Immune serum interacted with the 10 poliovirus strains in a dose-dependent manner. The seroconversion rates against all the tested poliovirus strains induced by the medium dose investigational sIPV, control cIPV, and control sIPV ranged from 91.3% to 100% (GMT 47.8-1303.2), 85.7% to 100% (GMT 95.2-514.0), and 82.6% to 100% (GMT 50.3-1481.2), respectively. CONCLUSION The investigational sIPV can induce good immunogenicity against the Sabin and Salk poliovirus strains, as well as the recently circulating poliovirus strains. TRIAL REGISTRATION : The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT04618783).",2021,"The seroconversion rates against all the tested poliovirus strains induced by the medium dose investigational sIPV, control cIPV, and control sIPV ranged from 91.3% to 100% (GMT 47.8-1303.2), 85.7% to 100% (GMT 95.2-514.0), and 82.6% to 100% (GMT 50.3-1481.2), respectively. ","['July 20, 2019, and January 10, 2020, and the study location was Pizhou city, Jiangsu province, China', '250 infant participants']","['Sabin strain-inactivated poliovirus vaccine (sIPV', 'Sabin inactivated poliovirus vaccine immunization', 'investigational sIPV with high, medium, and low antigen content, conventional inactivated poliovirus vaccine (cIPV), and control sIPV']",['seroconversion rates'],"[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0036106', 'cui_str': 'Salk Vaccine'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C4042908', 'cui_str': 'Seroconversion'}]",250.0,0.106999,"The seroconversion rates against all the tested poliovirus strains induced by the medium dose investigational sIPV, control cIPV, and control sIPV ranged from 91.3% to 100% (GMT 47.8-1303.2), 85.7% to 100% (GMT 95.2-514.0), and 82.6% to 100% (GMT 50.3-1481.2), respectively. ","[{'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Chu', 'Affiliation': 'Department of Vaccine Evaluation, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, 210009, China.'}, {'ForeName': 'Weixiao', 'Initials': 'W', 'LastName': 'Han', 'Affiliation': 'Department of Vaccine Evaluation, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, 210009, China.'}, {'ForeName': 'Deyu', 'Initials': 'D', 'LastName': 'Jiang', 'Affiliation': 'Department of Vaccine Evaluation, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, 210009, China.'}, {'ForeName': 'Zhiwei', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'Department of Vaccine Evaluation, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, 210009, China.'}, {'ForeName': 'Taotao', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': 'Department of Vaccine Evaluation, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, 210009, China.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Vaccine Evaluation, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, 210009, China.'}, {'ForeName': 'Yuemei', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Vaccine Evaluation, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, 210009, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Zeng', 'Affiliation': 'Department of Vaccine Evaluation, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, 210009, China.'}]",Expert review of vaccines,['10.1080/14760584.2021.1919091'] 4183,33863241,Randomized pilot study of a special education advocacy program for Latinx/minority parents of children with autism spectrum disorder.,"LAY ABSTRACT Persistent racial and ethnic disparities in obtaining an autism spectrum disorder diagnosis and services have been documented for Latinx children and other racial/ethnic minorities. This study reports on an educational intervention examining the effectiveness and feasibility of a low-intensity (i.e. three sessions), low-cost, parent advocacy for Latinx and other minority parents of children with autism. Results indicated significantly increased parental knowledge and in the immediate intervention group, but this knowledge did not lead to greater empowerment. While parents from low-income, racial/ethnic minority backgrounds, particularly Latinx parents, can significantly increase their advocacy skills with a low-intensity, low-cost program, they may need more support in changing their self-perceptions of empowerment and advocacy.",2021,"Results indicated significantly increased parental knowledge and in the immediate intervention group, but this knowledge did not lead to greater empowerment.","['Latinx/minority parents of children with autism spectrum disorder', 'minority parents of children with autism']","['educational intervention', 'special education advocacy program']","['advocacy skills', 'parental knowledge']","[{'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013649', 'cui_str': 'Special Education'}, {'cui': 'C0150446', 'cui_str': 'Advocacy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0150446', 'cui_str': 'Advocacy'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.00660687,"Results indicated significantly increased parental knowledge and in the immediate intervention group, but this knowledge did not lead to greater empowerment.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Luelmo', 'Affiliation': 'San Diego State University, USA.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Kasari', 'Affiliation': 'University of California, Los Angeles, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Fiesta Educativa, Inc., USA.'}]",Autism : the international journal of research and practice,['10.1177/1362361321998561'] 4184,33862624,Thalamic Deep Brain Stimulation for Spasmodic Dysphonia: A Phase I Prospective Randomized Double-Blind Crossover Trial.,"BACKGROUND Adductor spasmodic dysphonia (SD) is a dystonia of the vocal folds causing difficulty with speech. The current standard of care is repeated botulinum toxin injections to weaken the adductor muscles. We sought to ameliorate the underlying neurological cause of SD with a novel therapy-deep brain stimulation (DBS). OBJECTIVE To assess the safety of DBS in SD through phase I trial, and to quantify the magnitude of any benefit. METHODS Six patients had left ventral intermediate nucleus (Vim) thalamic DBS and were randomized to 3 mo blinded-DBS ""on"" or ""off"" followed by a crossover. Primary outcomes were quality of life and quality of voice during the blinded phase. Patients continued with open-DBS ""on."" Secondary outcomes were comparisons of pre- and 1-yr cognitive, mood, and quality of life. This trial was registered with ClinicalTrials.gov (NCT02558634). RESULTS There were no complications. Every patient reported an improvement in quality of life (P = .07) and had an improvement in quality of their voice (P = .06) when their blinded DBS was ""on"" versus ""off."" The trend did not reach statistical significance with the small sample size. Secondary outcomes showed no difference in cognition, an improvement in mood, and quality of life at 1 yr. CONCLUSION This phase I randomized controlled trial confirmed that DBS can be performed safely in patients with SD. Blinded DBS produced a strong trend toward improved quality of life and objective quality of voice despite the small sample size. The cerebellar circuit, not the pallidal circuit, appears to be crucial for motor control of the vocal folds.",2021,"Every patient reported an improvement in quality of life (P = .07) and had an improvement in quality of their voice (P = .06) when their blinded DBS was ""on"" versus ""off.""","['Six patients had left ventral intermediate nucleus (Vim) thalamic DBS', 'Spasmodic Dysphonia', 'patients with SD']","['DBS', 'novel therapy-deep brain stimulation (DBS', 'botulinum toxin injections']","['quality of life', 'pre- and 1-yr cognitive, mood, and quality of life', 'quality of life and objective quality of voice', 'quality of their voice', 'quality of life and quality of voice', 'cognition, an improvement in mood, and quality of life']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0264588', 'cui_str': 'Spastic dysphonia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1321035', 'cui_str': 'Injection of botulinum toxin'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0042943', 'cui_str': 'Vocal quality'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",6.0,0.600605,"Every patient reported an improvement in quality of life (P = .07) and had an improvement in quality of their voice (P = .06) when their blinded DBS was ""on"" versus ""off.""","[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Honey', 'Affiliation': 'Division of Neurosurgery, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Marie T', 'Initials': 'MT', 'LastName': 'Krüger', 'Affiliation': 'Department of Neurosurgery, Cantonal Hospital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Timóteo', 'Initials': 'T', 'LastName': 'Almeida', 'Affiliation': 'Division of Neurosurgery, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Linda A', 'Initials': 'LA', 'LastName': 'Rammage', 'Affiliation': 'Division of Otolaryngology and School of Audiology and Speech Sciences, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Mandeep S', 'Initials': 'MS', 'LastName': 'Tamber', 'Affiliation': 'Division of Neurosurgery, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Murray D', 'Initials': 'MD', 'LastName': 'Morrison', 'Affiliation': 'Division of Otolaryngology, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Anujan', 'Initials': 'A', 'LastName': 'Poologaindran', 'Affiliation': 'Brain Mapping Unit, Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Hu', 'Affiliation': 'Division of Otolaryngology, University of British Columbia, Vancouver, Canada.'}]",Neurosurgery,['10.1093/neuros/nyab095'] 4185,33862589,Human challenge study with a Shigella bioconjugate vaccine: Analyses of clinical efficacy and correlate of protection.,"BACKGROUND Shigellosis is a major cause of moderate to severe diarrhoea and dysentery in children under 5 years of age in low and middle-income countries. The Flexyn2a vaccine conjugates the O-polysaccharide of Shigella flexneri 2a to Pseudomonas aeruginosa exotoxin A. We describe a Phase 2b proof-of-concept challenge study that evaluated safety, immunogenicity, and efficacy of the Flexyn2a vaccine to protect against shigellosis. METHODS In this randomized, double blind, placebo-controlled trial, healthy adults were randomized 1:1 to receive Flexyn2a (10 µg) or placebo intramuscularly, twice, 4 weeks apart, followed by challenge 4 weeks later with 1500 colony forming units (CFUs) of S. flexneri 2a strain 2457T. The primary outcome was vaccine-induced protection. S. flexneri 2a lipopolysaccharide (LPS)-specific immune responses were assessed. FINDINGS Sixty-seven subjects were enrolled, 34 received vaccine and 33 placebo. The vaccine was well tolerated; the majority of adverse events were mild in nature. Thirty vaccinees and 29 placebo recipients received the S. flexneri 2a challenge. Vaccination resulted in a 30.2% reduction in shigellosis compared with placebo (13/30 vs. 18/29; p = 0.11; 95% CI -15 to 62.6). Vaccine efficacy was more robust against severe disease, reaching 51.7% (p = 0.015, 95% CI 5.3 to 77.9) against moderate/severe diarrhoea or dysentery concurrent with fever or severe enteric symptoms and 72.4% (p = 0.07) against more severe diarrhoea (≥10 lose stools or ≥1000 g loose stools/24 h). Vaccinated subjects were less likely to need early antibiotic intervention following challenge (protective efficacy 51.7%, p = 0.01; 95% CI 9 to 76.8). In those who developed shigellosis, vaccinated subjects had a lower disease severity score (p = 0.002) than placebo-recipients. Additionally, LPS-specific serum IgG responses in Flexyn2a recipients were associated with protection against disease (p = 0.0016) and with a decreased shigellosis disease score (p = 0.002). INTERPRETATION The Flexyn2a bioconjugate vaccine was immunogenic, well tolerated and protected against severe illness after Shigella challenge and is a promising Shigella vaccine construct. We identified a strong association between anti-S. flexneri 2a serum IgG and a reduction in disease outcomes. (Clinicaltrials.gov, NCT02646371.) FUNDING: Funding for this study was through a grant from the Wellcome Trust.",2021,"Vaccine efficacy was more robust against severe disease, reaching 51.7% (p = 0.015, 95% CI 5.3 to 77.9) against moderate/severe diarrhoea or dysentery concurrent with fever or severe enteric symptoms and 72.4% (p = 0.07) against more severe diarrhoea (≥10 lose stools or ≥1000 g loose stools/24 h).","['Sixty-seven subjects were enrolled, 34 received', 'healthy adults', '2457T', 'children under 5 years of age in low and middle-income countries']","['flexneri 2a strain', 'Flexyn2a', 'Shigella bioconjugate vaccine', 'placebo', 'S. flexneri 2a lipopolysaccharide ', 'Flexyn2a vaccine', 'vaccine and 33 placebo']","['safety, immunogenicity, and efficacy', 'vaccine-induced protection', 'Vaccine efficacy', 'shigellosis disease score', 'LPS-specific serum IgG responses', 'LPS)-specific immune responses', 'severe diarrhoea', 'moderate/severe diarrhoea or dysentery concurrent with fever or severe enteric symptoms', 'disease severity score']","[{'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0013371', 'cui_str': 'Infection by Shigella'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013371', 'cui_str': 'Infection by Shigella'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C1443924', 'cui_str': 'Severe diarrhea'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0013369', 'cui_str': 'Infectious diarrheal disease'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}]",67.0,0.408844,"Vaccine efficacy was more robust against severe disease, reaching 51.7% (p = 0.015, 95% CI 5.3 to 77.9) against moderate/severe diarrhoea or dysentery concurrent with fever or severe enteric symptoms and 72.4% (p = 0.07) against more severe diarrhoea (≥10 lose stools or ≥1000 g loose stools/24 h).","[{'ForeName': 'Kawsar R', 'Initials': 'KR', 'LastName': 'Talaat', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States. Electronic address: ktalaat@jhu.edu.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Alaimo', 'Affiliation': 'LimmaTech Biologics AG, Schlieren, Switzerland.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Martin', 'Affiliation': 'LimmaTech Biologics AG, Schlieren, Switzerland.'}, {'ForeName': 'A Louis', 'Initials': 'AL', 'LastName': 'Bourgeois', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States; Now at PATH Center for Vaccine Innovation and Access, Washington, DC, United States.'}, {'ForeName': 'Anita M', 'Initials': 'AM', 'LastName': 'Dreyer', 'Affiliation': 'LimmaTech Biologics AG, Schlieren, Switzerland.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Kaminski', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, United States.'}, {'ForeName': 'Chad K', 'Initials': 'CK', 'LastName': 'Porter', 'Affiliation': 'Naval Medical Research Center, Silver Spring, MD, United States.'}, {'ForeName': 'Subhra', 'Initials': 'S', 'LastName': 'Chakraborty', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Kristen A', 'Initials': 'KA', 'LastName': 'Clarkson', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, United States.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Brubaker', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Elwood', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Rahel', 'Initials': 'R', 'LastName': 'Frölich', 'Affiliation': 'LimmaTech Biologics AG, Schlieren, Switzerland.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'DeNearing', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Hailey', 'Initials': 'H', 'LastName': 'Weerts', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, United States.'}, {'ForeName': 'Brittany L', 'Initials': 'BL', 'LastName': 'Feijoo', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Halpern', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sack', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Riddle', 'Affiliation': 'Naval Medical Research Center, Silver Spring, MD, United States.'}, {'ForeName': 'Veronica Gambillara', 'Initials': 'VG', 'LastName': 'Fonck', 'Affiliation': 'LimmaTech Biologics AG, Schlieren, Switzerland.'}]",EBioMedicine,['10.1016/j.ebiom.2021.103310'] 4186,33862582,A genetically defined signature of responsiveness to erlotinib in early-stage pancreatic cancer patients: Results from the CONKO-005 trial.,"BACKGROUND high recurrence rates of up to 75% within 2 years in pancreatic ductal adenocarcinoma (PDAC) patients resected for cure indicate a high medical need for clinical prediction tools and patient specific treatment approaches. Addition of the EGFR inhibitor erlotinib to adjuvant chemotherapy failed to improve outcome but its efficacy in some patients warrants predictors of responsiveness. PATIENTS AND METHODS we analysed tumour samples from 293 R0-resected patients from the randomized, multicentre phase III CONKO-005 trial (gemcitabine ± erlotinib) with targeted sequencing, copy number, and RNA expression analyses. FINDINGS a total of 1086 mutations and 4157 copy-number aberrations (CNAs) with a mean of 17.9 /tumour were identified. Main pathways affected by genetic aberrations were the MAPK-pathway (99%), cell cycle control (92%), TGFβ signalling (77%), chromatin remodelling (71%), and the PI3K/AKT pathway (65%). Based on genetic signatures extracted with non-negative matrix factorization we could define five patient clusters, which differed in mutation patterns, gene expression profiles, and survival. In multivariable Cox regression analysis, SMAD4 aberrations were identified as a negative prognostic marker in the gemcitabine arm, an effect that was counteracted when treated with erlotinib (DFS: HR=1.59, p = 0.016, and OS: HR = 1.67, p = 0.014). Integration of differential gene expression analysis established SMAD4 alterations with low MAPK9 expression (n = 91) as a predictive biomarker for longer DFS (HR=0.49; test for interaction, p = 0.02) and OS (HR = 0.32; test for interaction, p = 0.001). INTERPRETATION this study identified five biologically distinct patient clusters with different actionable lesions and unravelled a previously unappreciated association of SMAD4 alteration status with erlotinib effectiveness. Confirmatory studies and mechanistic experiments are warranted to challenge the hypothesis that SMAD4 status might guide addition of erlotinib treatment in early-stage PDAC patients.",2021,"Main pathways affected by genetic aberrations were the MAPK-pathway (99%), cell cycle control (92%), TGFβ signalling (77%), chromatin remodelling (71%), and the PI3K/AKT pathway (65%).","['early-stage pancreatic cancer patients', 'we analysed tumour samples from 293 R0-resected patients from the randomized, multicentre phase III CONKO-005 trial', 'early-stage PDAC patients', 'a total of 1086 mutations and 4157 copy-number aberrations (CNAs) with a mean of 17.9 /tumour were identified']","['gemcitabine', 'gemcitabine\xa0±\xa0erlotinib', 'erlotinib']","['chromatin remodelling', 'cell cycle control', 'TGFβ signalling']","[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}]","[{'cui': 'C0008546', 'cui_str': 'Chromatin'}, {'cui': 'C1155872', 'cui_str': 'Cell Cycle Control'}]",,0.114327,"Main pathways affected by genetic aberrations were the MAPK-pathway (99%), cell cycle control (92%), TGFβ signalling (77%), chromatin remodelling (71%), and the PI3K/AKT pathway (65%).","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hoyer', 'Affiliation': 'Department of Hematology, Oncology, and Tumor Immunology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Augustenburger Platz 1, Berlin 13353, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hablesreiter', 'Affiliation': 'Department of Pathology and Tumor Biology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'Department of Pathology and Tumor Biology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': 'Department of Pathology and Tumor Biology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Briest', 'Affiliation': 'Department of Hematology, Oncology, and Tumor Immunology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Augustenburger Platz 1, Berlin 13353, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Christen', 'Affiliation': 'Department of Hematology, Oncology, and Tumor Immunology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Augustenburger Platz 1, Berlin 13353, Germany.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Kakiuchi', 'Affiliation': 'Department of Pathology and Tumor Biology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Yoshizato', 'Affiliation': 'Department of Pathology and Tumor Biology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Shiozawa', 'Affiliation': 'Department of Pathology and Tumor Biology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Shiraishi', 'Affiliation': 'Laboratory of DNA information Analysis, Human Genome Centre, Institute of Medical Science, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Striefler', 'Affiliation': 'Department of Hematology, Oncology, and Tumor Immunology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Augustenburger Platz 1, Berlin 13353, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bischoff', 'Affiliation': 'Department of Hematology, Oncology, and Tumor Immunology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Augustenburger Platz 1, Berlin 13353, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lohneis', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Pathology, Berlin, Germany; Institute of Pathology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Blau', 'Affiliation': 'Department of Hematology, Oncology, and Tumor Immunology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Augustenburger Platz 1, Berlin 13353, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Keilholz', 'Affiliation': 'Charité Comprehensive Cancer Center, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Bullinger', 'Affiliation': 'Department of Hematology, Oncology, and Tumor Immunology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Augustenburger Platz 1, Berlin 13353, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Pelzer', 'Affiliation': 'Department of Hematology, Oncology, and Tumor Immunology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Augustenburger Platz 1, Berlin 13353, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hummel', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Pathology, Berlin, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Riess', 'Affiliation': 'Department of Hematology, Oncology, and Tumor Immunology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Augustenburger Platz 1, Berlin 13353, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ogawa', 'Affiliation': 'Department of Pathology and Tumor Biology, Graduate School of Medicine, Kyoto University, Kyoto, Japan; Institute for the Advanced Study of Human Biology (WPI-ASHBi), Kyoto University, Kyoto, Japan; Department of Medicine, Centre for Haematology and Regenerative Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sinn', 'Affiliation': 'Department of Hematology, Oncology, and Tumor Immunology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Augustenburger Platz 1, Berlin 13353, Germany; Department of Oncology, Hematology and Bone Marrow Transplantation with Division of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Damm', 'Affiliation': 'Department of Hematology, Oncology, and Tumor Immunology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Augustenburger Platz 1, Berlin 13353, Germany; German Cancer Consortium (DKTK), partner site Berlin, Berlin, Germany; German Cancer Research Center (DKFZ), Heidelberg, Germany. Electronic address: frederik.damm@charite.de.'}]",EBioMedicine,['10.1016/j.ebiom.2021.103327'] 4187,33862570,Adopting low-shot deep learning for the detection of conjunctival melanoma using ocular surface images.,"BACKGROUND AND OBJECTIVE The purpose of the present study was to investigate low-shot deep learning models applied to conjunctival melanoma detection using a small dataset with ocular surface images. METHODS A dataset was composed of anonymized images of four classes; conjunctival melanoma (136), nevus or melanosis (93), pterygium (75), and normal conjunctiva (94). Before training involving conventional deep learning models, two generative adversarial networks (GANs) were constructed to augment the training dataset for low-shot learning. The collected data were randomly divided into training (70%), validation (10%), and test (20%) datasets. Moreover, 3D melanoma phantoms were designed to build an external validation set using a smartphone. The GoogleNet, InceptionV3, NASNet, ResNet50, and MobileNetV2 architectures were trained through transfer learning and validated using the test and external validation datasets. RESULTS The deep learning model demonstrated a significant improvement in the classification accuracy of conjunctival lesions using synthetic images generated by the GAN models. MobileNetV2 with GAN-based augmentation displayed the highest accuracy of 87.5% in the four-class classification and 97.2% in the binary classification for the detection of conjunctival melanoma. It showed an accuracy of 94.0% using 3D melanoma phantom images captured using a smartphone camera. CONCLUSIONS The present study described a low-shot deep learning model that can detect conjunctival melanomas using ocular surface images. To the best of our knowledge, this study is the first to develop a deep learning model to detect conjunctival melanoma using a digital imaging device such as smartphone camera.",2021,The deep learning model demonstrated a significant improvement in the classification accuracy of conjunctival lesions using synthetic images generated by the GAN models.,"['four classes; conjunctival melanoma (136), nevus or melanosis (93), pterygium (75), and normal conjunctiva (94']",['low-shot deep learning'],[],"[{'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0346360', 'cui_str': 'Malignant melanoma of conjunctiva'}, {'cui': 'C0027960', 'cui_str': 'Nevi'}, {'cui': 'C0025209', 'cui_str': 'Melanosis'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0009758', 'cui_str': 'Conjunctival structure'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}]",[],,0.0719816,The deep learning model demonstrated a significant improvement in the classification accuracy of conjunctival lesions using synthetic images generated by the GAN models.,"[{'ForeName': 'Tae Keun', 'Initials': 'TK', 'LastName': 'Yoo', 'Affiliation': 'Department of Ophthalmology, Aerospace Medical Center, Republic of Korea Air Force, Cheongju, Republic of Korea. Electronic address: eyetaekeunyoo@gmail.com.'}, {'ForeName': 'Joon Yul', 'Initials': 'JY', 'LastName': 'Choi', 'Affiliation': 'Epilepsy Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA. Electronic address: jychoi717@gmail.com.'}, {'ForeName': 'Hong Kyu', 'Initials': 'HK', 'LastName': 'Kim', 'Affiliation': 'Department of Ophthalmology, Dankook University Hospital, Dankook University College of Medicine, Cheonan, South Korea.'}, {'ForeName': 'Ik Hee', 'Initials': 'IH', 'LastName': 'Ryu', 'Affiliation': 'B&VIIT Eye Center, Seoul, South Korea; VISUWORKS, Seoul, South Korea.'}, {'ForeName': 'Jin Kuk', 'Initials': 'JK', 'LastName': 'Kim', 'Affiliation': 'B&VIIT Eye Center, Seoul, South Korea; VISUWORKS, Seoul, South Korea.'}]",Computer methods and programs in biomedicine,['10.1016/j.cmpb.2021.106086'] 4188,33865239,Intermediate vs Standard-dose Prophylactic Anticoagulation in Patients with COVID-19 Admitted to ICU: Ninety-day Results from the INSPIRATION Trial.,"BACKGROUND Thrombotic complications are considered among the main extrapulmonary manifestations of COVID-19. The optimal type and duration of prophylactic antithrombotic therapy in these patients remain unknown. METHODS This manuscript reports the final (90-day) results of the Intermediate versus Standard-dose Prophylactic anticoagulation In cRitically-ill pATIents with COVID-19: An opeN label randomized controlled trial (INSPIRATION) study. Patients with COVID-19 admitted to intensive care were randomized to intermediate-dose versus standard-dose prophylactic anticoagulation for 30 days, irrespective of hospital discharge status. The primary efficacy outcome was a composite of adjudicated venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation (ECMO), or all-cause death. The main safety outcome was major bleeding. RESULTS Of 600 randomized patients, 562 entered the modified intention-to-treat analysis (median age [Q1, Q3]; 62 (50, 71) years; 237 (42.2%) women), of whom 336 (59.8%) survived to hospital discharge. The primary outcome occurred in 132 (47.8%) of patients assigned to intermediate-dose and 130 (45.4%) patients assigned to standard-dose prophylactic anticoagulation (hazard ratio [HR]: 1.21, 95% confidence interval [CI]: 0.95-1.55, P=0.11). No significant differences were observed between the two groups for other efficacy outcomes, or in the landmark analysis from days 31-90. Overall, there were 7 (2.5%) major bleeding events in the intermediate-dose group (including 3 fatal events) and 4 (1.4%) major bleeding events in the standard-dose group (none fatal) (HR: 1.82, 95% CI: 0.53-6.24, P=0.33). CONCLUSION Intermediate-dose compared with standard-dose prophylactic anticoagulation did not reduce a composite of death, treatment with ECMO, or venous or arterial thrombosis at 90-day follow-up.",2021,"No significant differences were observed between the two groups for other efficacy outcomes, or in the landmark analysis from days 31-90.","['Patients with COVID-19 admitted to intensive care', '600 randomized patients', 'Patients with COVID-19 Admitted to ICU', ' 562 entered the modified intention-to-treat analysis (median age [Q1, Q3]; 62 (50, 71) years; 237 (42.2%) women), of whom 336 (59.8%) survived to hospital discharge', 'cRitically-ill pATIents with COVID-19']","['prophylactic antithrombotic therapy', 'Prophylactic anticoagulation', 'intermediate-dose versus standard-dose prophylactic anticoagulation']","['major bleeding events', 'major bleeding', 'composite of adjudicated venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation (ECMO), or all-cause death', 'composite of death, treatment with ECMO, or venous or arterial thrombosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0151942', 'cui_str': 'Arterial thrombosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",600.0,0.475845,"No significant differences were observed between the two groups for other efficacy outcomes, or in the landmark analysis from days 31-90.","[{'ForeName': 'Behnood', 'Initials': 'B', 'LastName': 'Bikdeli', 'Affiliation': 'Cardiovascular Research Foundation, New York, United States.'}, {'ForeName': 'Azita H', 'Initials': 'AH', 'LastName': 'Talasaz', 'Affiliation': 'Tehran Heart Center, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Rashidi', 'Affiliation': 'Tuberclosis and Lung Diseases Research Center, Tabriz, Iran (the Islamic Republic of).'}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Bakhshandeh', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Farnaz', 'Initials': 'F', 'LastName': 'Rafiee', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Matin', 'Affiliation': 'Tuberclosis and Lung Diseases Research Center, Tabriz, Iran (the Islamic Republic of).'}, {'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Baghizadeh', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Rezaeifar', 'Affiliation': 'Tuberculosis and lung diseases research center, Tabriz University of Medical Sciences, Tabriz, Iran, Tabriz, Iran (the Islamic Republic of).'}, {'ForeName': 'Sepehr', 'Initials': 'S', 'LastName': 'Jamalkhani', 'Affiliation': 'Iran University of Medical Sciences, Student Research Committee, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Ooria', 'Initials': 'O', 'LastName': 'Tahamtan', 'Affiliation': 'Tuberculosis and lung diseases research center, Tabriz University of Medical Sciences, Tabriz, Iran, Tabriz, Iran (the Islamic Republic of).'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Sharif-Kashani', 'Affiliation': 'Shahid Beheshti University of Medical Sciences, Tobacoo Prevention and control Research center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Mohammad Taghi', 'Initials': 'MT', 'LastName': 'Beigmohammadi', 'Affiliation': 'Tehran University of Medical Sciences, Anesthesiology and Intensive Care, Imam Khomeini Hospital Complex, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Farrokhpour', 'Affiliation': 'Iran University of Medical Sciences, Firouzgar hospital, Department of internal medicine, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Seyed Hashem', 'Initials': 'SH', 'LastName': 'Sezavar', 'Affiliation': 'Iran University of Medical Sciences, Rasoul-e-Akram Hospital, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Pooya', 'Initials': 'P', 'LastName': 'Payandemehr', 'Affiliation': 'Tehran University of Medical Sciences, Sina hospital, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Dabbagh', 'Affiliation': 'Shahid Beheshti University of Medical Sciences, Department of Anesthesiology, School of Medicine Anesthesiology Research Center, Shahid Modarres Hospital, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Keivan', 'Initials': 'K', 'LastName': 'Gohari Moghadam', 'Affiliation': 'Tehran University of Medical Sciences, Department of Internal Medicine, Shariati Hospital, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Khalili', 'Affiliation': 'Tehran University of Medical Sciences, Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Yadollahzadeh', 'Affiliation': 'Iran University of Medical Sciences, Firouzgar hospital, Department of internal medicine, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Taghi', 'Initials': 'T', 'LastName': 'Riahi', 'Affiliation': 'Iran University of Medical Sciences, Rasoul-e-Akram Hospital, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Abedini', 'Affiliation': 'Shahid Beheshti University of Medical Sciences, Chronic Respiratory Disease Research Center, Masih Daneshvari Hospital, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Lookzadeh', 'Affiliation': 'Shahid Beheshti University of Medical Sciences, Chronic Respiratory Disease Research Center, Masih Daneshvari Hospital, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Rahmani', 'Affiliation': 'Tehran University of Medical Sciences, Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Zoghi', 'Affiliation': 'Tehran University of Medical Sciences, School of Pharmacy, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Keyhan', 'Initials': 'K', 'LastName': 'Mohammadi', 'Affiliation': 'Tehran University of Medical Sciences, School of Pharmacy, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Pardis', 'Initials': 'P', 'LastName': 'Sadeghipour', 'Affiliation': 'Iran University of Medical Sciences, Firouzgar hospital, Department of internal medicine, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Homa', 'Initials': 'H', 'LastName': 'Abri', 'Affiliation': 'Iran University of Medical Sciences, Firouzgar hospital, Department of internal medicine, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Tabrizi', 'Affiliation': 'Iran University of Medical Sciences, Rasoul-e-Akram Hospital, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Seyed Masoud', 'Initials': 'SM', 'LastName': 'Mousavian', 'Affiliation': 'Iran University of Medical Sciences, Rasoul-e-Akram Hospital, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Shaghayegh', 'Initials': 'S', 'LastName': 'Shahmirzaei', 'Affiliation': 'Tehran University of Medical Sciences, Sina hospital, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Amin', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Bahram', 'Initials': 'B', 'LastName': 'Mohebbi', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Cardiovascular Intervention Research Center, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Seyed Ehsan', 'Initials': 'SE', 'LastName': 'Parhizgar', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Rasoul', 'Initials': 'R', 'LastName': 'Aliannejad', 'Affiliation': 'Tehran University of Medical Sciences, Department of Pulmonary and Critical Care, Shariati hospital, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Eslami', 'Affiliation': 'Shahid Beheshti University of Medical Sciences, Cardiovascular Research Center, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Kashefizadeh', 'Affiliation': 'Shahid Beheshti University of Medical Sciences, Shahid Dr. Labbafinejad Hospital, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dobesh', 'Affiliation': 'University of Nebraska Medical Center, College of Pharmacy, Omaha, United States.'}, {'ForeName': 'Hessam', 'Initials': 'H', 'LastName': 'Kakavand', 'Affiliation': 'Tehran University of Medical Sciences, School of Pharmacy, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Seyed Hossein', 'Initials': 'SH', 'LastName': 'Hosseini', 'Affiliation': 'Tehran University of Medical Sciences, School of Pharmacy, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Shafaghi', 'Affiliation': 'Shahid Beheshti University of Medical Sciences, Lung Transplantion Research Center, Department of Cardiology, National Research Institute of Tuberculosls and Lung Diseases (NRITLD), Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Samrand', 'Initials': 'S', 'LastName': 'Fattah Ghazi', 'Affiliation': 'Tehran University of Medical Sciences, Imam Khomeini Hospital Complex, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Atabak', 'Initials': 'A', 'LastName': 'Najafi', 'Affiliation': 'Tehran University of Medical Sciences, Sina hospital, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jiménez', 'Affiliation': 'Ramón y Cajal Hospital, IRYCIS and Alcalá de Henares University, Respiratory Division, Medicine Department, Madrid, Spain.'}, {'ForeName': 'Aakriti', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Cardiovascular Research Foundation, New York, United States.'}, {'ForeName': 'Mahesh V', 'Initials': 'MV', 'LastName': 'Madhavan', 'Affiliation': 'Cardiovascular Research Foundation, New York, United States.'}, {'ForeName': 'Sanjum', 'Initials': 'S', 'LastName': 'Sethi', 'Affiliation': 'Columbia University Irving Medical Center, Gastroenterology, New York, United States.'}, {'ForeName': 'Sahil A', 'Initials': 'SA', 'LastName': 'Parikh', 'Affiliation': 'Columbia University Medical Center and the Cardiovascular Research Foundation, New York, United States.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Monreal', 'Affiliation': 'Hospital Germans Trias i Pujol, Internal Medicine, Badalona, Spain.'}, {'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Hadavand', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Hajighasemi', 'Affiliation': 'Tehran Heart Center, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Maleki', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Sadeghian', 'Affiliation': 'Tehran Heart Center, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Piazza', 'Affiliation': ""Brigham and Women's Hospital, Cardiovascular Medicine Division, Boston, United States.""}, {'ForeName': 'Ajay J', 'Initials': 'AJ', 'LastName': 'Kirtane', 'Affiliation': 'Columbia University Medical Center and the Cardiovascular Research Foundation, New York City, United States.'}, {'ForeName': 'Benjamin W', 'Initials': 'BW', 'LastName': 'Van Tassell', 'Affiliation': 'Virginia Commonwealth University School of Pharmacy, Department of Pharmacotherapy and Outcomes Science, Richmond, United States.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Columbia University Medical Center and the Cardiovascular Research Foundation, New York, United States.'}, {'ForeName': 'Gregory Yh', 'Initials': 'GY', 'LastName': 'Lip', 'Affiliation': 'University of Liverpool Institute of Ageing and Chronic Disease, Liverpool Centre for Cardiovascular Science, Liverpool, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Harlan', 'Initials': 'H', 'LastName': 'Krumholz', 'Affiliation': 'Yale University Center for Outcomes Research and Evaluation, New Haven, United States.'}, {'ForeName': 'Samuel Z', 'Initials': 'SZ', 'LastName': 'Goldhaber', 'Affiliation': ""Brigham and Women's Hospital, Medicine, Boston, United States.""}, {'ForeName': 'Parham', 'Initials': 'P', 'LastName': 'Sadeghipour', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Tehran, Iran (the Islamic Republic of).'}]",Thrombosis and haemostasis,['10.1055/a-1485-2372'] 4189,33865218,The effects of stroboscopic balance training on cortical activities in athletes with chronic ankle instability.,"OBJECTIVES To investigate the effect of a 6-week stroboscopic balance training program on cortical activities in athletes with chronic ankle instability. DESIGN Randomized controlled trial. SETTING Single-center. PARTICIPANTS Thirty-nine participants were assigned to the strobe group (SG, n = 13), non-strobe group (NSG, n = 13), and control group (CG, n = 13). MAIN OUTCOME MEASURES Cortical activity and balance velocity were evaluated while the athletes were on the HUBER balance device. Electroencephalographic measurements of cortical activity were made at the transition from bipedal stance to single-leg stance. RESULTS The SG showed significant increases in Cz theta and alpha values and COP-v (center of pressure velocity) between pretest and posttest (p < 0.001, p = 0.003, p < 0.001). Posttest Cz theta was significantly higher in the SG compared to the CG (p = 0.009) and posttest Cz alpha was significantly higher in the SG compared to the NSG (p = 0.039) and CG (p = 0.001). Posttest COP-v was significantly higher in the SG than in the CG (p = 0.031) and NSG (p = 0.03). CONCLUSIONS Stroboscopic training may be clinically beneficial to improve balance parameters in athletes with CAI, and may have utility in sport-specific activity phases of rehabilitation to reduce visual input and increase motor control.",2021,"Posttest COP-v was significantly higher in the SG than in the CG (p = 0.031) and NSG (p = 0.03). ","['Thirty-nine participants', 'athletes with CAI', 'Single-center', 'athletes with chronic ankle instability']","['strobe group (SG, n\xa0=\xa013), non-strobe group (NSG, n\xa0=\xa013), and control group (CG, n\xa0=\xa013', 'stroboscopic balance training', 'stroboscopic balance training program', 'Stroboscopic training']","['posttest Cz alpha', 'cortical activities', 'Cortical activity and balance velocity', 'Posttest Cz theta', 'Cz theta and alpha values and COP-v (center of pressure velocity', 'HUBER balance device', 'Electroencephalographic measurements of cortical activity']","[{'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0064494', 'cui_str': 'carboxyamido-triazole'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0056471', 'cui_str': 'creatinolfosfate'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0179199', 'cui_str': 'Balance'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",39.0,0.0292279,"Posttest COP-v was significantly higher in the SG than in the CG (p = 0.031) and NSG (p = 0.03). ","[{'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Uzlaşır', 'Affiliation': 'School of Sports Sciences and Technology, Nevşehir Hacı Bektaş Veli University, Nevşehir, 50300, Turkey.'}, {'ForeName': 'Kamile Y', 'Initials': 'KY', 'LastName': 'Özdıraz', 'Affiliation': 'Erciyes University, Gevher Nesibe Institute, Department of Neuroscience, Turkey.'}, {'ForeName': 'Osman', 'Initials': 'O', 'LastName': 'Dağ', 'Affiliation': 'Faculty of Medicine Department of Biostatistics Hacettepe University, Ankara, 06100, Turkey.'}, {'ForeName': 'Volga B', 'Initials': 'VB', 'LastName': 'Tunay', 'Affiliation': 'Faculty of Physical Therapy and Rehabilitation Hacettepe University, Ankara, 06100, Turkey. Electronic address: volgatunay@hacettepe.edu.tr.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2021.03.014'] 4190,33865147,Response to targeted cognitive training may be neuroprotective in patients with early schizophrenia.,"Individuals with schizophrenia exhibit widespread cortical thinning associated with illness severity and deficits in cognition. However, intact cortical thickness (CTh) may serve as a protective factor. The current study sought to examine changes in CTh in response to auditory targeted cognitive training (TCT) in individuals with recent onset schizophrenia. Participants underwent MRI scanning and a cognitive assessment before and after being randomly assigned to 40 h of either TCT (N = 21) or a computer games control condition (CG; N = 22) over 16 weeks. Groups did not differ at baseline on demographic variables or measures of CTh. At the level of group averages, neither group showed significant pre-post changes in CTh in any brain region. However, changes in CTh related to individual differences in treatment outcome, as improved global cognition in the TCT group corresponded to reduced cortical thinning in frontal, temporal, parietal, and occipital lobes. These relationships were not observed in the CG group. The current findings suggest that TCT may be neuroprotective in early schizophrenia, such that individuals who improved in response to training also showed a reduction in cortical thinning that may be otherwise hastened due to age and illness.",2021,Groups did not differ at baseline on demographic variables or measures of CTh.,"['patients with early schizophrenia', 'Individuals with schizophrenia', 'individuals with recent onset schizophrenia']","['cognitive training', 'TCT', 'MRI scanning', 'computer games control condition', 'auditory targeted cognitive training (TCT']","['demographic variables or measures of CTh', 'global cognition']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0870328', 'cui_str': 'Computer Games'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.0243762,Groups did not differ at baseline on demographic variables or measures of CTh.,"[{'ForeName': 'Ian S', 'Initials': 'IS', 'LastName': 'Ramsay', 'Affiliation': 'University of Minnesota, Department of Psychiatry and Behavioral Sciences, USA. Electronic address: ramsa045@umn.edu.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Fryer', 'Affiliation': 'University of California, San Francisco, Department of Psychiatry and Behavioral Science, USA; San Francisco Veterans Affairs Medical Center, USA.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Roach', 'Affiliation': 'University of California, San Francisco, Department of Psychiatry and Behavioral Science, USA; San Francisco Veterans Affairs Medical Center, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Boos', 'Affiliation': 'University of California, San Francisco, Department of Psychiatry and Behavioral Science, USA; San Francisco Veterans Affairs Medical Center, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Fisher', 'Affiliation': 'University of Minnesota, Department of Psychiatry and Behavioral Sciences, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Loewy', 'Affiliation': 'University of California, San Francisco, Department of Psychiatry and Behavioral Science, USA; San Francisco Veterans Affairs Medical Center, USA.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Ford', 'Affiliation': 'University of California, San Francisco, Department of Psychiatry and Behavioral Science, USA; San Francisco Veterans Affairs Medical Center, USA.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Vinogradov', 'Affiliation': 'University of Minnesota, Department of Psychiatry and Behavioral Sciences, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Mathalon', 'Affiliation': 'University of California, San Francisco, Department of Psychiatry and Behavioral Science, USA; San Francisco Veterans Affairs Medical Center, USA.'}]",Psychiatry research. Neuroimaging,['10.1016/j.pscychresns.2021.111285'] 4191,33865010,[Long-term effect analysis of a cognitive stimulation program in mild cognitive impairment elderly in Primary Care: A randomized controlled trial].,"OBJECTIVE To provide evidence about the efficacy of a community health intervention through a cognitive stimulation program at long term in older people with mild cognitive impairment. DESIGN Randomized controlled trial (CONSORT group norms). LOCATION San José Norte-Centro Primary Care Center and La Caridad Foundation (Zaragoza, Spain). PARTICIPANTS Twenty-nine people over 65 years old with a 24-27 MEC score that completed 48 months follow up. They were randomized between the intervention group (15) and the control group (14). INTERVENTIONS The intervention was applied in 10 sessions of 45min for 10 weeks using the red notebook tool for mental activation that works memory, orientation, language, praxis, gnosis, calculation, perception, logical reasoning, attention and executive functions. MAIN MEASUREMENTS The main outcome variables were MEC-35, Set-test, Barthel index, Lawton-Brody scale, Goldberg anxiety scale and Yesavage geriatric depression scale short form. RESULTS Increases of the main result variable over the baseline level of MEC-35 were analyzed. On average, the intervention group obtained higher scores than control: 3.14 points post intervention, 3.76 points after 6 months and 2.26 points more than control group after 12 months. All the differences were statistically significant. After 48 months the intervention group obtained 2 points more than control group. The intervention did not improve verbal fluency, activity daily living and mood. CONCLUSIONS Our cognitive stimulation program seems to improve cognitive performance, measured with the variable MEC-35 at post intervention, 6, 12 and 48 months. There is no evidence of improvement in verbal fluency, activity daily livings and mood. Clinicaltrials.gov Identifier: NCT03831061.",2021,"On average, the intervention group obtained higher scores than control: 3.14 points post intervention, 3.76 points after 6 months and 2.26 points more than control group after 12 months.","['mild cognitive impairment elderly in Primary Care', 'older people with mild cognitive impairment', 'Twenty-nine people over 65 years old with a 24-27 MEC score that completed 48 months follow up']","['community health intervention', 'cognitive stimulation program']","['cognitive performance', 'verbal fluency, activity daily livings and mood', 'verbal fluency, activity daily living and mood', 'MEC-35, Set-test, Barthel index, Lawton-Brody scale, Goldberg anxiety scale and Yesavage geriatric depression scale short form']","[{'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0206694', 'cui_str': 'Mucoepidermoid carcinoma'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150174', 'cui_str': 'Cognitive stimulation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0206694', 'cui_str': 'Mucoepidermoid carcinoma'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C2919619', 'cui_str': 'Geriatric depression scale short form'}]",,0.0705223,"On average, the intervention group obtained higher scores than control: 3.14 points post intervention, 3.76 points after 6 months and 2.26 points more than control group after 12 months.","[{'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Gómez-Soria', 'Affiliation': 'Fundación La Caridad, Zaragoza, España; Departamento de Fisiatría y Enfermería, Facultad de Ciencias de la Salud, Universidad de Zaragoza, Zaragoza, España.'}, {'ForeName': 'Eva María', 'Initials': 'EM', 'LastName': 'Andrés Esteban', 'Affiliation': 'Grupo «Manejo del paciente sangrante» - IDIPaz (Hospital Universitario La Paz - Madrid). Universidad Rey Juan Carlos, Madrid, España.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Gómez Bruton', 'Affiliation': 'GENUD (Growth, Exercise, Nutrition and Development Research group), Departamento de Fisiatría y Enfermería, Área de Educación Física y Deportiva; Facultad de Ciencias de la Salud y del Deporte, Universidad de Zaragoza, Huesca, España.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Peralta-Marrupe', 'Affiliation': 'Residencia Reyes de Aragón/Orpea, Zaragoza, España. Electronic address: peraltamarrupe@hotmail.com.'}]",Atencion primaria,['10.1016/j.aprim.2021.102053'] 4192,33864109,Olfactory training with Aromastics: olfactory and cognitive effects.,"PURPOSE The olfactory system can be successfully rehabilitated with regular, intermittent stimulation during multiple daily exposures to selected sets of odors, i.e., olfactory training (OT). OT has been repeatedly shown to be an effective tool of olfactory performance enhancement. Recent advancements in studies on OT suggest that its beneficial effects exceed olfaction and extend to specific cognitive tasks. So far, studies on OT provided compelling evidence for its effectiveness, but there is still a need to search for an optimal OT protocol. The present study examined whether increased frequency of OT leads to better outcomes in both olfactory and cognitive domains. METHOD Fifty-five subjects (28 females; M age  = 58.2 ± 11.3 years; 26 patients with impaired olfaction) were randomly assigned to a standard (twice a day) or intense (four times a day) OT. Olfactory and cognitive measurements were taken before and after OT. RESULTS OT performed twice a day was more effective in supporting olfactory rehabilitation and interventions targeted to verbal semantic fluency than OT performed four times a day, even more so in subjects with lower baseline scores. CONCLUSIONS OT is effective in supporting olfactory rehabilitation and interventions targeted to verbal semantic fluency. However, it may be prone to a ceiling effect, being efficient in subjects presenting with lower baseline olfactory performance and lower verbal semantic fluency.",2021,"RESULTS OT performed twice a day was more effective in supporting olfactory rehabilitation and interventions targeted to verbal semantic fluency than OT performed four times a day, even more so in subjects with lower baseline scores. ",['Fifty-five subjects (28 females; M age \u2009=\u200958.2\u2009±\u200911.3\xa0years; 26 patients with impaired olfaction'],[],"['verbal semantic fluency', 'Olfactory and cognitive measurements']","[{'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}]",[],"[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",55.0,0.0263979,"RESULTS OT performed twice a day was more effective in supporting olfactory rehabilitation and interventions targeted to verbal semantic fluency than OT performed four times a day, even more so in subjects with lower baseline scores. ","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Oleszkiewicz', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, TU Dresden, Fetscherstrasse 74, 01307, Dresden, Germany. ania.oleszkiewicz@gmail.com.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bottesi', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, TU Dresden, Fetscherstrasse 74, 01307, Dresden, Germany.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Pieniak', 'Affiliation': 'Institute of Psychology, University of Wroclaw, ul. Dawida 1, 50-527, Wroclaw, Poland.'}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Fujita', 'Affiliation': 'Sony Corporation, New Business & Technology Development Group, 1-7-1 Konan Minato-ku, Tokyo, 108-0075, Japan.'}, {'ForeName': 'Nadejda', 'Initials': 'N', 'LastName': 'Krasteva', 'Affiliation': 'Sony Europe B.V., RD Center Stuttgart Laboratory 2, Hedelfingerstr. 61, 70327, Stuttgart, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Nelles', 'Affiliation': 'Sony Europe B.V., RD Center Stuttgart Laboratory 2, Hedelfingerstr. 61, 70327, Stuttgart, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hummel', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, TU Dresden, Fetscherstrasse 74, 01307, Dresden, Germany.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-021-06810-9'] 4193,33864070,Markers of vitamin D metabolism and premenstrual symptoms in healthy women with regular cycles.,"STUDY QUESTION Are insufficient 25-hydroxyvitamin D (25(OH)D) concentrations, and other markers of vitamin D metabolism, associated with premenstrual symptoms in healthy women with regular menstrual cycles? SUMMARY ANSWER 25(OH)D insufficiency was associated with specific physical premenstrual symptoms, while no associations were observed with psychological symptoms or with other markers of vitamin D metabolism. WHAT IS KNOWN ALREADY Prior studies evaluating vitamin D and premenstrual symptoms have yielded mixed results, and it is unknown whether 25(OH)D insufficiency and other markers of vitamin D metabolism are associated with premenstrual symptoms. STUDY DESIGN, SIZE, DURATION We used two cohorts of women with regular menstrual cycles; 1191 women aged 18-40 years in EAGeR (cross-sectional analysis of a prospective cohort within a randomized trial) and 76 women aged 18-44 years in BioCycle (prospective cohort). In EAGeR, premenstrual symptoms over the previous year were assessed at baseline, whereas in BioCycle, symptoms were assessed prospectively at multiple points over two menstrual cycles with symptoms queried over the previous week. In both cohorts, symptomatology was assessed via questionnaire regarding presence and severity of 14 physical and psychological symptoms the week before and after menses. Both studies measured 25(OH)D in serum. We also evaluated the association of additional markers of vitamin D metabolism and calcium homeostasis, including intact parathyroid hormone (iPTH), calcium (Ca), fibroblast growth factor 23 (FGF23), and 1,25 dihydroxyvitamin D (1,25(OH)2D) with premenstrual symptoms in the BioCycle cohort. PARTICIPANTS/MATERIALS, SETTING, METHODS One cohort of women actively seeking pregnancy (Effects of Aspirin in Gestation and Reproduction (EAGeR)) and one cohort not seeking pregnancy (BioCycle) were evaluated. Log-binomial regression was used to estimate risk ratios (RR) and 95% CIs for associations between insufficient 25(OH)D (<30 ng/ml) and individual premenstrual symptoms, adjusting for age, BMI, race, smoking, income, physical activity, and season of blood draw. MAIN RESULTS AND THE ROLE OF CHANCE 25(OH)D insufficiency was associated with increased risk of breast fullness/tenderness (EAGeR RR 1.27, 95% CI 1.03, 1.55; BioCycle RR 1.37, 95% CI 0.56, 3.32) and generalized aches and pains (EAGeR RR 1.33, 95% CI 1.01, 1.78; BioCycle 1.36, 95% CI 0.41, 4.45), though results were imprecise in the BioCycle study. No associations were observed between insufficient 25(OH)D and psychological symptoms in either cohort. In BioCycle, iPTH, Ca, FGF23, and 1,25(OH) 2D were not associated with any premenstrual symptoms. LIMITATIONS, REASONS FOR CAUTION Results from the EAGeR study were limited by the study design, which assessed both 25(OH)D at baseline and individual premenstrual symptoms over the past year at the baseline. As such, reverse causality is a potential concern. Though premenstrual symptoms were assessed prospectively in the BioCycle cohort, the power was limited due to small sample size. However, results were fairly consistent across both studies. WIDER IMPLICATIONS OF THE FINDINGS Serum 25(OH)D may be associated with risk and severity of specific physical premenstrual symptoms. STUDY FUNDING/COMPETING INTEREST(S) This work was supported by the Intramural Research Program of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland (Contract nos. HHSN267200603423, HHSN267200603424, and HHSN267200603426). JG.R. and D.L.K. have been funded by the NIH Medical Research Scholars Program, a public-private partnership jointly supported by the NIH and generous contributions to the Foundation for the NIH by the Doris Duke Charitable Foundation (Grant #2014194), the American Association for Dental Research, the Colgate Palmolive Company, Genentech, and other private donors. For a complete list, visit the foundation website at http://www.fnih.org. The authors have no conflicts of interest to disclose. TRIAL REGISTRATION NUMBER Clinicaltrials.gov NCT00467363.",2021,No associations were observed between insufficient 25(OH)D and psychological symptoms in either cohort.,"['healthy women with regular menstrual cycles', 'women with regular menstrual cycles; 1191 women aged 18-40\u2009years in EAGeR (cross-sectional analysis of a prospective cohort within a randomized trial) and 76 women aged 18-44\u2009years in BioCycle (prospective cohort', 'healthy women with regular cycles', 'One cohort of women actively seeking pregnancy (Effects of Aspirin in Gestation and Reproduction (EAGeR)) and one cohort not seeking pregnancy (BioCycle) were evaluated']",['vitamin D metabolism'],"['risk of breast fullness/tenderness', 'insufficient 25(OH)D and psychological symptoms', 'intact parathyroid hormone (iPTH), calcium (Ca), fibroblast growth factor 23 (FGF23), and 1,25 dihydroxyvitamin D (1,25(OH)2D) with premenstrual symptoms', 'specific physical premenstrual symptoms', 'generalized aches and pains']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0558083', 'cui_str': 'Enthusiastic'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0962301', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C0370232', 'cui_str': '1,25-dihydroxyvitamin D'}, {'cui': 'C0232959', 'cui_str': 'Premenstrual symptom'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0281856', 'cui_str': 'Generalized aches and pains'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.178456,No associations were observed between insufficient 25(OH)D and psychological symptoms in either cohort.,"[{'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Alkhalaf', 'Affiliation': 'Maternal and Child Health Program, School of Public Health, University of Maryland, College Park, MD, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Kuhr', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Radoc', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Purdue-Smithe', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'A Z', 'Initials': 'AZ', 'LastName': 'Pollack', 'Affiliation': 'Department of Global and Community Health, College of Health and Human Services, George Mason University, Fairfax, VA, USA.'}, {'ForeName': 'S F', 'Initials': 'SF', 'LastName': 'Yisahak', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah and Intermountain Healthcare, Salt Lake City, UT, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Thoma', 'Affiliation': 'Maternal and Child Health Program, School of Public Health, University of Maryland, College Park, MD, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kissell', 'Affiliation': 'Department of Endocrinology, Diabetes and Metabolism, Guthrie Medical Group, PC, Sayre, PA, USA.'}, {'ForeName': 'N J', 'Initials': 'NJ', 'LastName': 'Perkins', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Sjaarda', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Mumford', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/deab089'] 4194,32128593,The effects of digital cognitive behavioral therapy for insomnia on cognitive function: a randomized controlled trial.,"STUDY OBJECTIVES We sought to examine the impact of digital cognitive behavioral therapy (dCBT) for insomnia on both self-reported cognitive impairment and objective cognitive performance. METHODS The Defining the Impact of Sleep improvement on Cognitive Outcomes (DISCO) trial was an online, two-arm, single-blind, randomized clinical trial of dCBT versus wait-list control. Participants were aged 25 years and older, met DSM-5 diagnostic criteria for insomnia disorder, and reported difficulties with concentration or memory. Assessments were carried out online at baseline, and 10 and 24 weeks post-randomization. The primary outcome measure was self-reported cognitive impairment, assessed with the British Columbia Cognitive Complaints Inventory (BC-CCI). Secondary outcomes included tests of cognitive performance, insomnia symptoms, cognitive failures, fatigue, sleepiness, depression, and anxiety. RESULTS Four hundred and ten participants with insomnia were recruited and assigned to dCBT (N = 205) or wait-list control (N = 205). At 10 weeks post-randomization the estimated adjusted mean difference for the BC-CCI was -3.03 (95% CI: -3.60, -2.47; p < 0.0001, d = -0.86), indicating that participants in the dCBT group reported less cognitive impairment than the control group. These effects were maintained at 24 weeks (d = -0.96) and were mediated, in part, via reductions in insomnia severity and increased sleep efficiency. Treatment effects in favor of dCBT, at both 10 and 24 weeks, were found for insomnia severity, sleep efficiency, cognitive failures, fatigue, sleepiness, depression, and anxiety. We found no between-group differences in objective tests of cognitive performance. CONCLUSIONS Our study shows that dCBT robustly decreases self-reported cognitive impairment at post-treatment and these effects are maintained at 6 months.",2020,"Treatment effects in favour of dCBT, at both 10 and 24 weeks, were found for insomnia severity, sleep efficiency, cognitive failures, fatigue, sleepiness, depression, and anxiety.","['Participants were aged 25 years and older, met DSM-5 diagnostic criteria for insomnia disorder and reported difficulties with concentration or memory', '410 participants with insomnia']","['digital cognitive behavioural therapy (dCBT', 'digital cognitive behavioural therapy', 'dCBT']","['insomnia severity, sleep efficiency, cognitive failures, fatigue, sleepiness, depression, and anxiety', 'cognitive impairment', 'tests of cognitive performance, insomnia symptoms, cognitive failures, fatigue, sleepiness, depression and anxiety', 'objective tests of cognitive performance', 'insomnia severity and increased sleep efficiency', 'cognitive function', 'self-reported cognitive impairment, assessed with the British Columbia Cognitive Complaints Inventory (BC-CCI']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0025260', 'cui_str': 'Memory'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0006193', 'cui_str': 'British Columbia'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",410.0,0.163297,"Treatment effects in favour of dCBT, at both 10 and 24 weeks, were found for insomnia severity, sleep efficiency, cognitive failures, fatigue, sleepiness, depression, and anxiety.","[{'ForeName': 'Simon D', 'Initials': 'SD', 'LastName': 'Kyle', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Madeleine E D', 'Initials': 'MED', 'LastName': 'Hurry', 'Affiliation': 'Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Emsley', 'Affiliation': 'Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, Kings College London, London, UK.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Marsden', 'Affiliation': 'Division of Population Health, Health Services Research & Primary Care, University of Manchester, Manchester, UK.'}, {'ForeName': 'Ximena', 'Initials': 'X', 'LastName': 'Omlin', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Amender', 'Initials': 'A', 'LastName': 'Juss', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Spiegelhalder', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, Medical Center - University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Lampros', 'Initials': 'L', 'LastName': 'Bisdounis', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Annemarie I', 'Initials': 'AI', 'LastName': 'Luik', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Colin A', 'Initials': 'CA', 'LastName': 'Espie', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Sexton', 'Affiliation': 'Oxford Centre for Human Brain Activity, Wellcome Centre for Integrative Neuroimaging, Department of Psychiatry, University of Oxford, Oxford, UK.'}]",Sleep,['10.1093/sleep/zsaa034'] 4195,30932889,"Effects of Composite Supplement Containing Astaxanthin and Sesamin on Cognitive Functions in People with Mild Cognitive Impairment: A Randomized, Double-Blind, Placebo-Controlled Trial.",,2019,,['People with Mild Cognitive Impairment'],"['Placebo', 'Composite Supplement Containing Astaxanthin and Sesamin']",['Cognitive Functions'],"[{'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0052565', 'cui_str': 'astaxanthin'}, {'cui': 'C0074405', 'cui_str': 'sesamin'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}]",,0.763997,,[],Journal of Alzheimer's disease : JAD,['10.3233/JAD-189016'] 4196,28179049,Promoting Hand Hygiene Compliance: PSYGIENE—a Cluster-Randomized Controlled Trial of Tailored Interventions,"BACKGROUND The German ""Clean Hands Campaign"" (an adaptation of the WHO ""Clean Care is Safer Care"" programme) to promote hand hygiene among hospital personnel at Hannover Medical School (MHH, Medizinische Hochschule Hannover), known as Aktion Saubere Hände (ASH), met with initial success. By 2013, however, compliance rates with hygienic hand disinfection in the hospital's ten intensive care units (ICUs) and two hematopoietic stem cell transplantation units (HSCTUs) had relapsed to their initial levels (physicians: 48%; nurses: 56%). The cluster- randomized controlled trial PSYGIENE was conducted to investigate whether interventions tai - lored in ways suggested by research in behavioral psychology might bring about more sustainable improvements than the ASH. METHODS The ""Health Action Process Approach"" (HAPA) compliance model specifies key psychological determinants of compliance. These determinants were assessed among health care workers in the ICUs and HSCTUs of the MHH by questionnaire (response rates: physicians: 71%; nurses: 63%) and by interviews of the responsible ward physicians and head nurses (100%). In 2013, 29 tailored behavior change techniques were implemented in educational training sessions and feedback discussions in the six wards that constituted the intervention arm of the trial, while ASH training sessions were provided in the control arm. The compliance rates for 2014 and 2015 (the primary outcomes of the trial) were determined by nonparticipating observation of hygienic hand disinfection, in accordance with the World Health Organization's gold standard. RESULTS The two groups did not differ in their baseline compliance rates in 2013 (intervention: 54%, control: 55%, p = 0.581). The tailored interventions led to increased compliance in each of the two follow-up years (2014: 64%, p<0.001; 2015: 70%, p = 0.001), while the compliance in the control arm increased to 68% in 2014 (p<0.001) but fell back to 64% in 2015 (p = 0.007). The compliance increases from 2013-2015 and the compliance rate in 2015 were higher in the intervention arm (p<0.005). This was mainly attributable to the nurses' behavior, as the corresponding parameters for physicians did not differ significantly between the two study arms in stratified analysis. CONCLUSION Tailored interventions based on behavioral psychology principles led to more sustainable increases in compliance with hand hygiene guidelines than ASH training sessions did. This was true among nurses, and thus also for hospital ward personnel as a whole (i.e., nurses and physicians combined). Further studies are needed to identify more target group-specific interventions that may improve compliance among physicians.",2017,The compliance increases from 2013-2015 and the compliance rate in 2015 were higher in the intervention arm (p<0.005).,[],[],"['compliance rate', 'baseline compliance rates', 'compliance rates']",[],[],"[{'cui': 'C0009563', 'cui_str': 'Compliance'}]",,0.0270369,The compliance increases from 2013-2015 and the compliance rate in 2015 were higher in the intervention arm (p<0.005).,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'von Lengerke', 'Affiliation': 'Centre for Public Health and Healthcare, Medical Psychology Unit, Hannover Medical School; Department of Diagnostics, Institute of Hygiene/Hospital Epidemiology, Leipzig University Hospital; Center for Public Health and Healthcare, Institute for Epidemiology, Social Medicine and Health Systems Research, Hannover Medical School; Centre for Laboratory Medicine, Institute for Medical Microbiology and Hospital Epidemiology, Hannover Medical School.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Lutze', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Krauth', 'Affiliation': ''}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Lange', 'Affiliation': ''}, {'ForeName': 'Jona Theodor', 'Initials': 'JT', 'LastName': 'Stahmeyer', 'Affiliation': ''}, {'ForeName': 'Iris Freya', 'Initials': 'IF', 'LastName': 'Chaberny', 'Affiliation': ''}]",Deutsches Arzteblatt international,['10.3238/arztebl.2017.0029'] 4197,31593985,Biphasic feature of placebo response in primary insomnia: pooled analysis of data from randomized controlled clinical trials of orexin receptor antagonists.,"OBJECTIVES The placebo response to orexin receptor antagonists in primary insomnia is little-known. Our aim was, therefore, to conduct a systematic review of placebo-controlled randomized clinical trials to characterize placebo response. METHODS We performed a comprehensive literature search for randomized, placebo-controlled, double-blind clinical trials evaluating the efficacy of orexin receptor antagonists addressing primary insomnia. To pool effect size estimates (Cohen's d) of placebo and orexin receptor antagonists across trials for outcome measures, a meta-analysis was done according to the Cochrane guideline. RESULTS The placebo response was significant and robust to improve the symptoms of insomnia in terms of objective and subjective measures, and the effects (0.70 ± 0.51) in subjective measures were smaller than that (1.10 ± 1.14) in objective measures (p = 0.027). The biphasic feature of placebo response showed an initial short-term increase of placebo effect and subsequent changeless long-term effect. CONCLUSION The biphasic feature of placebo response is clinically useful, and neuroimaging is essential to clarify the long-term mechanism in the future.",2020,"The placebo response was significant and robust to improve the symptoms of insomnia in terms of objective and subjective measures, and the effects (0.70 ± 0.51) in subjective measures were smaller than that (1.10 ± 1.14) in objective measures (p = 0.027).",['Primary Insomnia'],"['placebo', 'Orexin Receptor Antagonists', 'orexin receptor antagonists', 'placebo and orexin receptor antagonists']","['symptoms of insomnia', 'subjective measures']","[{'cui': 'C0033139', 'cui_str': 'Primary Insomnia'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4019081', 'cui_str': 'Orexin Receptor Blockers'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.561516,"The placebo response was significant and robust to improve the symptoms of insomnia in terms of objective and subjective measures, and the effects (0.70 ± 0.51) in subjective measures were smaller than that (1.10 ± 1.14) in objective measures (p = 0.027).","[{'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'He', 'Affiliation': 'Department of Neurology, Nanchong Central Hospital, The Second Clinical Medical College, North Sichuan Medical College, Nanchong, Sichuan, China.'}, {'ForeName': 'Binghu', 'Initials': 'B', 'LastName': 'Jiang', 'Affiliation': 'Imaging Institute of Brain Function, Department of Radiology, Nanchong Central Hospital, The Second Clinical Medical College, North Sichuan Medical College, Nanchong, Sichuan, China.'}, {'ForeName': 'Zhiwei', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': 'Imaging Institute of Brain Function, Department of Radiology, Nanchong Central Hospital, The Second Clinical Medical College, North Sichuan Medical College, Nanchong, Sichuan, China.'}, {'ForeName': 'Qiwen', 'Initials': 'Q', 'LastName': 'Mu', 'Affiliation': 'Imaging Institute of Brain Function, Department of Radiology, Nanchong Central Hospital, The Second Clinical Medical College, North Sichuan Medical College, Nanchong, Sichuan, China.'}, {'ForeName': 'Morgan A', 'Initials': 'MA', 'LastName': 'Mcclure', 'Affiliation': 'Imaging Institute of Brain Function, Department of Radiology, Nanchong Central Hospital, The Second Clinical Medical College, North Sichuan Medical College, Nanchong, Sichuan, China.'}]",Sleep,['10.1093/sleep/zsz238'] 4198,32193277,Maximising trichiasis surgery success (MTSS) trial: rationale and design of a randomised controlled trial to improve trachomatous trichiasis surgical outcomes.,"INTRODUCTION Trachomatous trichiasis (TT) is a condition in which the eyelid turns inward and eyelashes abrade the front part of the eye. To prevent eventual blindness, surgery is recommended. Two surgical procedures are commonly used, bilamellar tarsal rotation (BLTR) and posterior lamellar tarsal rotation (PLTR). Evidence suggests that incision height and surgery type may affect the risk of postoperative TT (PTT) and other surgical outcomes. However, these studies have not prospectively compared the impact of incision height on surgical outcomes. METHODS AND ANALYSIS Maximising trichiasis surgery Success (MTSS) is a three-arm, randomised clinical trial being conducted in Ethiopia. Participants will be randomly assigned on a 1:1:1 basis to BLTR with a 3 mm incision height, BLTR with a 5 mm incision height, or PLTR 3 mm incision height. Patients are eligible for the trial if they have previously unoperated upper eyelid TT. Follow-up visits will be conducted by trained eye examiners at 1 day, 2 weeks, 6 weeks and 12 months after surgery. The primary outcome is incident PTT within 1 year following surgery. Logistic regression will be used in an intention-to-treat analysis to assess outcome incidence by surgical approach. ETHICS AND DISSEMINATION The University of North Carolina and Johns Hopkins School of Medicine institution review boards, Ethiopian National Research Ethics Review Committee and Ethiopian Food, Medicine, Healthcare and Administration and Control Authority provided ethics approval for the trial. On completion, trial results will be disseminated at local and international meetings and in peer-reviewed journals. TRIAL REGISTRATION NUMBER NCT03100747.",2020,Evidence suggests that incision height and surgery type may affect the risk of postoperative TT (PTT) and other surgical outcomes.,[],"['Trachomatous trichiasis (TT', 'Maximising trichiasis surgery Success (MTSS', 'BLTR with a 3 mm incision height, BLTR with a 5 mm incision height, or PLTR 3 mm incision height']","['risk of postoperative TT (PTT', 'incident PTT within 1 year following surgery', 'bilamellar tarsal rotation (BLTR) and posterior lamellar tarsal rotation (PLTR']",[],"[{'cui': 'C0221259', 'cui_str': 'Trichiasis'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}]",,0.359538,Evidence suggests that incision height and surgery type may affect the risk of postoperative TT (PTT) and other surgical outcomes.,"[{'ForeName': 'Belay', 'Initials': 'B', 'LastName': 'Bayissasse', 'Affiliation': 'Orbis International Ethiopia, Addis Ababa, Ethiopia.'}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Sullivan', 'Affiliation': 'Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Shannath L', 'Initials': 'SL', 'LastName': 'Merbs', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Munoz', 'Affiliation': 'Department of Ophthalmology, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Keil', 'Affiliation': 'Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Alemayehu', 'Initials': 'A', 'LastName': 'Sisay', 'Affiliation': 'Orbis International Ethiopia, Addis Ababa, Ethiopia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Singer', 'Affiliation': 'Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Emily W', 'Initials': 'EW', 'LastName': 'Gower', 'Affiliation': 'Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA egower@unc.edu.'}]",BMJ open,['10.1136/bmjopen-2019-036327'] 4199,32133486,Comparison of post-treatment changes with and without retention in adolescents treated for maxillary impacted canines-a randomized controlled trial.,"OBJECTIVE To evaluate whether retention is needed after orthodontic treatment of impacted maxillary canines. TRIAL DESIGN Two-arm parallel group single-centre randomized controlled trial. MATERIALS AND METHODS Sixty-three patients, 39 girls and 24 boys, were recruited to the study. The inclusion criteria were patients with at least one impacted or unerupted maxillary canine, and moderate irregularity of the maxillary six anterior teeth according to Little's index (LI). After gaining informed consent from the patient and their custodians, the patients were randomized to one of two groups, i.e. to a non-retention group or a retention group. The randomization process was prepared and carried out by an independent person not involved in the trial and the randomization used blocks of 20 (10 + 10). Primary outcomes were changes in single contact point discrepancy, and LI measured on digitalized three-dimensional study casts 1-year post-treatment. The study casts were anonymized before assessment and the changes were blinded for the assessor. Data were evaluated on an intention-to-treat basis. Thus, all randomized patients were incorporated into the final analysis. In the non-retention group a 10-week interim period was used to detect patients who eventually have a relapse immediately after treatment. If so, the patient got the arch-wire reinserted. Most patients in the retention group received a vacuum-formed retainer and pretreatment spacing cases got a bonded retainer. RESULTS Mean irregularity change was 0.4 mm in the retention and 1.3 mm in the non-retention group (P < 0.001). Maximum change was 2.5 mm in the retention and 3.2 mm in the non-retention group (P < 0.001). Most changes in the non-retention group occurred during the 10-week interim period. In the non-retention group, one patient developed contact point discrepancy of >2 mm during the interim period and was realigned. HARMS One patient met the stopping guideline criteria. This patient had the arch wire reinserted for 2 months. After realignment, the patient received a retention appliance. LIMITATIONS The trial was a single-centre study and short-term changes were evaluated. CONCLUSIONS Changes between the retention and the non-retention group were statistically but not clinically significant. Since satisfactory clinical results 1-year post-treatment were found in the non-retention group, retention does not appear to be needed. The 10-week interim period was useful in detecting patients who might have a relapse immediately after treatment. TRIAL REGISTRATION The trial was not registered.",2021,Mean irregularity change was 0.4 mm in the retention and 1.3 mm in the non-retention group (P < 0.001).,"['Sixty-three patients, 39 girls and 24 boys, were recruited to the study', 'adolescents treated for maxillary impacted canines', ""The inclusion criteria were patients with at least one impacted or unerupted maxillary canine, and moderate irregularity of the maxillary six anterior teeth according to Little's index (LI""]",['vacuum-formed retainer and pretreatment spacing cases got a bonded retainer'],"['contact point discrepancy', 'Mean irregularity change', 'Maximum change', 'changes in single contact point discrepancy, and LI measured on digitalized three-dimensional study casts 1-year post-treatment']","[{'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0700321', 'cui_str': 'Small (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C4551580', 'cui_str': 'Retainer (attribute)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0441421', 'cui_str': 'Permanent Retainer'}]","[{'cui': 'C1290905', 'cui_str': 'Discrepancy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0554831', 'cui_str': 'Digitalization done (situation)'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0302143', 'cui_str': 'Casts (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",63.0,0.128779,Mean irregularity change was 0.4 mm in the retention and 1.3 mm in the non-retention group (P < 0.001).,"[{'ForeName': 'Sasan', 'Initials': 'S', 'LastName': 'Naraghi', 'Affiliation': 'Orthodontic Clinic, National Health Service, Växjö, Sweden.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Ganzer', 'Affiliation': 'Department of Orthodontics, University of Malmö, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bondemark', 'Affiliation': 'Department of Orthodontics, University of Malmö, Sweden.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Sonesson', 'Affiliation': 'Department of Orthodontics, University of Malmö, Sweden.'}]",European journal of orthodontics,['10.1093/ejo/cjaa010'] 4200,31631216,Evaluating the surrogacy of multiple vaccine-induced immune response biomarkers in HIV vaccine trials.,"Identifying biomarkers as surrogates for clinical endpoints in randomized vaccine trials is useful for reducing study duration and costs, relieving participants of unnecessary discomfort, and understanding vaccine-effect mechanism. In this article, we use risk models with multiple vaccine-induced immune response biomarkers to measure the causal association between a vaccine's effects on these biomarkers and that on the clinical endpoint. In this setup, our main objective is to combine and select markers with high surrogacy from a list of many candidate markers, allowing us to get a more parsimonious model which can potentially increase the predictive quality of the true markers. To address the missing ""potential"" biomarker value if a subject receives placebo, we utilize the baseline immunogenicity predictor design augmented with a ""closeout placebo vaccination"" group. We then impute the missing potential marker values and conduct marker selection through a stepwise resampling and imputation method called stability selection. We test our proposed strategy under relevant simulation settings and on (partially simulated) biomarker data from a HIV vaccine trial (RV144).",2021,"Identifying biomarkers as surrogates for clinical endpoints in randomized vaccine trials is useful for reducing study duration and costs, relieving participants of unnecessary discomfort, and understanding vaccine-effect mechanism.",['HIV vaccine trials'],['placebo'],[],[{'cui': 'C0086413'}],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.0905939,"Identifying biomarkers as surrogates for clinical endpoints in randomized vaccine trials is useful for reducing study duration and costs, relieving participants of unnecessary discomfort, and understanding vaccine-effect mechanism.","[{'ForeName': 'Sayan', 'Initials': 'S', 'LastName': 'Dasgupta', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, Seattle, WA 98122, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, Seattle, WA 98122, USA.'}]","Biostatistics (Oxford, England)",['10.1093/biostatistics/kxz039'] 4201,31782961,Sleepiness as motivation: a potential mechanism for how sleep deprivation affects behavior.,"STUDY OBJECTIVES To determine how sleepiness and sleep deprivation drive the motivation to engage in different behaviors. METHODS We studied the sleepiness of 123 participants who had been randomized to sleep deprivation or normal sleep, and their willingness to engage in a range of everyday behaviors. RESULTS Self-reported sleepiness was a strong predictor of the motivation to engage in sleep-preparatory behaviors such as shutting one's eyes (OR = 2.78, 95% CI: 2.19-3.52 for each step up on the Karolinska Sleepiness Scale) and resting (OR = 3.20, CI: 2.46-4.16). Sleepiness was also related to the desire to be cared for by a loved one (OR = 1.49, CI: 1.22-1.82), and preparedness to utilize monetary and energy resources to get to sleep. Conversely, increased sleepiness was associated with a decreased motivation for social and physical activities (e.g. be with friends OR = 0.71, CI: 0.61-0.82; exercise OR = 0.65, CI: 0.56-0.76). Sleep deprivation had similar effects as sleepiness on these behaviors. Neither sleepiness nor sleep deprivation had strong associations with hunger, thirst, or food preferences. CONCLUSIONS Our findings indicate that sleepiness is a dynamic motivational drive that promotes sleep-preparatory behaviors and competes with other drives and desired outcomes. Consequently, sleepiness may be a central mechanism by which impaired alertness, for example, due to insufficient sleep, contributes to poor quality of life and adverse health. We propose that sleepiness helps organize behaviors toward the specific goal of assuring sufficient sleep, in competition with other needs and incentives. A theoretical framework on sleepiness and its behavioral consequences are likely to improve our understanding of several disease mechanisms.",2020,"Sleepiness was also related to the desire to be cared for by a loved one (OR=1.49, CI: 1.22-1.82), and preparedness to utilize monetary and energy resources to get to sleep.","['123 participants who had been randomized to sleep deprivation or normal sleep, and their willingness to engage in a range of everyday behaviors']",[],"['Sleepiness as motivation', 'increased sleepiness', 'Sleepiness', 'motivation for social and physical activities']","[{'cui': 'C0037316', 'cui_str': 'Sleep Deprivation'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",[],"[{'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",123.0,0.0440609,"Sleepiness was also related to the desire to be cared for by a loved one (OR=1.49, CI: 1.22-1.82), and preparedness to utilize monetary and energy resources to get to sleep.","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Axelsson', 'Affiliation': 'Stress Research Institute, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ingre', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Göran', 'Initials': 'G', 'LastName': 'Kecklund', 'Affiliation': 'Stress Research Institute, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Lekander', 'Affiliation': 'Stress Research Institute, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Kenneth P', 'Initials': 'KP', 'LastName': 'Wright', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, CO.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Sundelin', 'Affiliation': 'Stress Research Institute, Stockholm University, Stockholm, Sweden.'}]",Sleep,['10.1093/sleep/zsz291'] 4202,32170961,"Combined use of cytology, p16 immunostaining and genotyping for triage of women positive for high-risk human papillomavirus at primary screening.","Human papillomavirus (HPV) testing is very sensitive for primary cervical screening but has low specificity. Triage tests that improve specificity but maintain high sensitivity are needed. Women enrolled in the experimental arm of Phase 2 of the New Technologies for Cervical Cancer randomized controlled cervical screening trial were tested for high-risk HPV (hrHPV) and referred to colposcopy if positive. hrHPV-positive women also had HPV genotyping (by polymerase chain reaction with GP5+/GP6+ primers and reverse line blotting), immunostaining for p16 overexpression and cytology. We computed sensitivity, specificity and positive predictive value (PPV) for different combinations of tests and determined potential hierarchical ordering of triage tests. A number of 1,091 HPV-positive women had valid tests for cytology, p16 and genotyping. Ninety-two of them had cervical intraepithelial neoplasia grade 2+ (CIN2+) histology and 40 of them had CIN grade 3+ (CIN3+) histology. The PPV for CIN2+ was >10% in hrHPV-positive women with positive high-grade squamous intraepithelial lesion (61.3%), positive low-grade squamous intraepithelial lesion (LSIL+) (18.3%) and positive atypical squamous cells of undetermined significance (14.8%) cytology, p16 positive (16.7%) and, hierarchically, for infections by HPV33, 16, 35, 59, 31 and 52 (in decreasing order). Referral of women positive for either p16 or LSIL+ cytology had 97.8% sensitivity for CIN2+ and women negative for both of these had a 3-year CIN3+ risk of 0.2%. Similar results were seen for women being either p16 or HPV16/33 positive. hrHPV-positive women who were negative for p16 and cytology (LSIL threshold) had a very low CIN3+ rate in the following 3 years. Recalling them after that interval and referring those positive for either test to immediate colposcopy seem to be an efficient triage strategy. The same applies to p16 and HPV16.",2020,Referral of women positive for either p16 or LSIL+ cytology had 97.8% sensitivity for CIN2+ and women negative for both of these had a 3-year CIN3+ risk of 0.2%.,"['Ninety two of them had CIN2+ histology and 40 CIN3', 'hrHPV positive women who were negative for p16 and cytology (LSIL threshold) had a very', 'Women enrolled in the experimental arm of phase 2 of the NTCC randomised controlled cervical screening trial were tested for high risk human papillomavirus (hrHPV) and referred to colposcopy if positive', '1091 HPV positive women']","['Cytology, P16 Immunostaining']","['LSIL', 'low CIN3+ rate']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0249880', 'cui_str': 'Cyclin-Dependent Kinase Inhibitor p16'}, {'cui': 'C0010820', 'cui_str': 'cytology'}, {'cui': 'C1302773', 'cui_str': 'Low-Grade Squamous Intraepithelial Lesions'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0009417', 'cui_str': 'Colposcopy'}]","[{'cui': 'C0010820', 'cui_str': 'cytology'}, {'cui': 'C0249880', 'cui_str': 'Cyclin-Dependent Kinase Inhibitor p16'}]","[{'cui': 'C1302773', 'cui_str': 'Low-Grade Squamous Intraepithelial Lesions'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",,,Referral of women positive for either p16 or LSIL+ cytology had 97.8% sensitivity for CIN2+ and women negative for both of these had a 3-year CIN3+ risk of 0.2%.,"[{'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Cuzick', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Adcock', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Carozzi', 'Affiliation': 'Regional Cancer Prevention Laboratory, Oncological Network, Prevention and Research Institute (ISPRO), Florence, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Gillio-Tos', 'Affiliation': 'Cancer Epidemiology Unit, Department of Medical Sciences, C.E.R.M.S, University of Turin, Turin, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'De Marco', 'Affiliation': 'Cancer Epidemiology Unit, Department of Medical Sciences, C.E.R.M.S, University of Turin, Turin, Italy.'}, {'ForeName': 'Annarosa', 'Initials': 'A', 'LastName': 'Del Mistro', 'Affiliation': 'Immunology and Diagnostic Molecular Oncology Unit, Veneto Institute of Oncology IOV IRCCS, Padua, Italy.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Frayle', 'Affiliation': 'Immunology and Diagnostic Molecular Oncology Unit, Veneto Institute of Oncology IOV IRCCS, Padua, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Girlando', 'Affiliation': 'Pathology Unit, S. Chiara Hospital, Trento, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Sani', 'Affiliation': 'Regional Cancer Prevention Laboratory, Oncological Network, Prevention and Research Institute (ISPRO), Florence, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Confortini', 'Affiliation': 'Regional Cancer Prevention Laboratory, Oncological Network, Prevention and Research Institute (ISPRO), Florence, Italy.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Zorzi', 'Affiliation': 'Veneto Tumour Registry, Azienda Zero, Padua, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Giorgi-Rossi', 'Affiliation': 'Epidemiology Unit, Azienda USL, IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Rizzolo', 'Affiliation': 'Centre for Cancer Prevention, AOU Città della Salute e della Scienza, Torino, Italy.'}, {'ForeName': 'Guglielmo', 'Initials': 'G', 'LastName': 'Ronco', 'Affiliation': 'Centre for Cancer Prevention, AOU Città della Salute e della Scienza, Torino, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of cancer,['10.1002/ijc.32973'] 4203,30655627,"Gender difference in the effects of cacao polyphenols on blood pressure and glucose/lipid metabolism in prediabetic subjects: a double-blinded, randomized, placebo-controlled crossover trial.",,2019,,['prediabetic subjects'],"['cacao polyphenols', 'placebo']",['blood pressure and glucose/lipid metabolism'],[],"[{'cui': 'C0006622', 'cui_str': 'Cocoa Plant'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}]",,0.615842,,"[{'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Shiina', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Tomiyama', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan. tomiyama@tokyo-med.ac.jp.'}, {'ForeName': 'Chisa', 'Initials': 'C', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Syunsuke', 'Initials': 'S', 'LastName': 'Komatsu', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Midori', 'Initials': 'M', 'LastName': 'Natsume', 'Affiliation': 'R&D Division, Meiji Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Chisato', 'Initials': 'C', 'LastName': 'Oba', 'Affiliation': 'R&D Division, Meiji Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Ohshiba', 'Affiliation': 'R&D Division, Meiji Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Taketo', 'Initials': 'T', 'LastName': 'Yamaji', 'Affiliation': 'R&D Division, Meiji Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Taishiro', 'Initials': 'T', 'LastName': 'Chikamori', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Yamashina', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-019-0208-8'] 4204,31593592,Connectedness Based on Shared Engagement Predicts Remote Biochemically Verified Quit Status Within Smoking Cessation Treatment Groups on Facebook.,"INTRODUCTION Engagement with online content and online social network integration are associated with smoking behavior change, but less is known about social dynamics of shared engagement between participants in group-based social media interventions. METHODS Participants were 251 young adult smokers aged 18 to 25 assigned to one of 29 secret Facebook groups tailored to their readiness to quit smoking (""pre-contemplation,"" ""contemplation,"" and ""preparation""). Groups varied in size and were randomly assigned to receive monetary incentives for engagement. All groups received daily posts for 90 days and were assessed for remote biochemically verified smoking abstinence at the end of the intervention. Across 29 groups, we examined associations between group features (group size, incentive condition, readiness to quit) with how connected members were within the group based on shared engagement with the same content (measured by density). At the individual level, we examined associations between 7-day biochemically verified smoking abstinence and how connected an individual was within the group (measured by degree centrality). RESULTS After adjusting for comment volume, being in a contemplation group (vs. pre-contemplation group) was associated with a decrease in comment-based density. Individual degree centrality was significantly associated with biochemically verified smoking abstinence for both comments and likes. CONCLUSIONS Future group-based social media interventions for smoking cessation may want to focus on promoting connected engagement between participants, rather than simply quantity of engagement. IMPLICATIONS Participants in a smoking cessation intervention delivered through Facebook groups were more likely to have biochemically verified smoking abstinence if they were more connected to the rest of the group via shared engagement. Promoting shared engagement between participants may be more likely to promote behavior change than volume of engagement alone.",2021,"Individual degree centrality was significantly associated with biochemically verified smoking abstinence for both comments and likes. ",['Participants were 251 young adult smokers aged 18 to 25 assigned to one of 29 secret'],"['Facebook groups tailored to their readiness to quit smoking (""pre-contemplation,"" ""contemplation,"" ""preparation']",[],"[{'cui': 'C0534009', 'cui_str': 'AM251'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]",[],251.0,0.0186241,"Individual degree centrality was significantly associated with biochemically verified smoking abstinence for both comments and likes. ","[{'ForeName': 'Meredith C', 'Initials': 'MC', 'LastName': 'Meacham', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Ou Stella', 'Initials': 'OS', 'LastName': 'Liang', 'Affiliation': 'College of Computing and Informatics, Drexel University, Philadelphia, PA.'}, {'ForeName': 'Mengnan', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'College of Computing and Informatics, Drexel University, Philadelphia, PA.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Yang', 'Affiliation': 'College of Computing and Informatics, Drexel University, Philadelphia, PA.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Thrul', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'Ramo', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz193'] 4205,32147654,Rationale and design of lifestyle intervention using mobile technology in patients with high cardiovascular risk: A pragmatic randomized clinical trial.,"Cardiovascular disease (CVD) is the leading cause of morbidity and mortality throughout the world and contributes a considerable burden to healthcare costs. Primary prevention strategies, particularly adopting healthy lifestyle habits, have great potential to reduce the risk of CVD. Patient compliance remains the major cause of the failure of primary prevention strategies. Telehealth interventions and gamification through mobile applications can increase adherence and reduce healthcare costs. The primary objective of this study is to compare the effect of lifestyle intervention using mobile technology plus usual care with usual care alone in patients with a high CVD risk.",2020,The primary objective of this study is to compare the effect of lifestyle intervention using mobile technology plus usual care with usual care alone in patients with a high CVD risk.,"['patients with a high CVD risk', 'patients with high cardiovascular risk']","['lifestyle intervention using mobile technology plus usual care with usual care alone', 'lifestyle intervention']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]",[],,0.0755905,The primary objective of this study is to compare the effect of lifestyle intervention using mobile technology plus usual care with usual care alone in patients with a high CVD risk.,"[{'ForeName': 'İlker', 'Initials': 'İ', 'LastName': 'Tekkesin', 'Affiliation': 'Department of Cardiology, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Center, İstanbul, Turkey.'}, {'ForeName': 'Göksel', 'Initials': 'G', 'LastName': 'Çinier', 'Affiliation': 'Department of Cardiology, Kaçkar State Hospital, Rize, Turkey.'}, {'ForeName': 'Mert', 'Initials': 'M', 'LastName': 'Hayıroğlu', 'Affiliation': 'Department of Cardiology, Sultan Abdulhamid Han Training and Research Hospital, İstanbul, Turkey.'}, {'ForeName': 'Yelda', 'Initials': 'Y', 'LastName': 'Soluk Özdemir', 'Affiliation': 'İstanbul Physical Medication and Rehabilitation Training and Research Hospital, İstanbul, Turkey.'}, {'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'Yıldırımtürk', 'Affiliation': 'Department of Cardiology, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Center, İstanbul, Turkey.'}, {'ForeName': 'Duygu', 'Initials': 'D', 'LastName': 'İnan', 'Affiliation': 'Department of Cardiology, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Center, İstanbul, Turkey.'}, {'ForeName': 'Elif Gökçen', 'Initials': 'EG', 'LastName': 'Vatanoğlu', 'Affiliation': 'Department of Cardiology, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Center, İstanbul, Turkey.'}, {'ForeName': 'Kemal Emrecan', 'Initials': 'KE', 'LastName': 'Parsova', 'Affiliation': 'Department of Cardiology, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Center, İstanbul, Turkey.'}, {'ForeName': 'Gizem', 'Initials': 'G', 'LastName': 'Yüksel', 'Affiliation': 'Department of Cardiology, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Center, İstanbul, Turkey.'}, {'ForeName': 'Furkan', 'Initials': 'F', 'LastName': 'Durak', 'Affiliation': 'Department of Cardiology, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Center, İstanbul, Turkey.'}, {'ForeName': 'Levent', 'Initials': 'L', 'LastName': 'Pay', 'Affiliation': 'Department of Cardiology, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Center, İstanbul, Turkey.'}]",Turk Kardiyoloji Dernegi arsivi : Turk Kardiyoloji Derneginin yayin organidir,['10.5543/tkda.2019.69494'] 4206,30942383,Corrigendum: Analysis of cluster-randomized test-negative designs: cluster-level methods.,,2019,,[],[],[],[],[],[],,0.119639,,"[{'ForeName': 'Nicholas P', 'Initials': 'NP', 'LastName': 'Jewell', 'Affiliation': 'London School of Hygiene & Tropical Medicine, Keppel Street, Bloomsbury, London, WC1E 7HT, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Dufault', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of California, Berkeley, CA 94720, USA.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Cutcher', 'Affiliation': 'World Mosquito Program, Institute of Vector Borne Disease, Monash University, Level 1, 12 Innovation Walk, Clayton, Victoria 3800, Australia.'}, {'ForeName': 'Cameron P', 'Initials': 'CP', 'LastName': 'Simmons', 'Affiliation': 'World Mosquito Program, Institute of Vector Borne Disease, Monash University, Level 1, 12 Innovation Walk, Clayton, Victoria 3800, Australia.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Anders', 'Affiliation': 'World Mosquito Program, Institute of Vector Borne Disease, Monash University, Level 1, 12 Innovation Walk, Clayton, Victoria 3800, Australia.'}]","Biostatistics (Oxford, England)",['10.1093/biostatistics/kxz008'] 4207,31872860,Examining the optimal timing for closed-loop auditory stimulation of slow-wave sleep in young and older adults.,"STUDY OBJECTIVES Closed-loop auditory stimulation (CLAS) is a method for enhancing slow oscillations (SOs) through the presentation of auditory clicks during sleep. CLAS boosts SOs amplitude and sleep spindle power, but the optimal timing for click delivery remains unclear. Here, we determine the optimal time to present auditory clicks to maximize the enhancement of SO amplitude and spindle likelihood. METHODS We examined the main factors predicting SO amplitude and sleep spindles in a dataset of 21 young and 17 older subjects. The participants received CLAS during slow-wave-sleep in two experimental conditions: sham and auditory stimulation. Post-stimulus SOs and spindles were evaluated according to the click phase on the SOs and compared between and within conditions. RESULTS We revealed that auditory clicks applied anywhere on the positive portion of the SO increased SO amplitudes and spindle likelihood, although the interval of opportunity was shorter in the older group. For both groups, analyses showed that the optimal timing for click delivery is close to the SO peak phase. Click phase on the SO wave was the main factor determining the impact of auditory stimulation on spindle likelihood for young subjects, whereas for older participants, the temporal lag since the last spindle was a better predictor of spindle likelihood. CONCLUSIONS Our data suggest that CLAS can more effectively boost SOs during specific phase windows, and these differ between young and older participants. It is possible that this is due to the fluctuation of sensory inputs modulated by the thalamocortical networks during the SO.",2020,"Click-phase on the SO wave was the main factor determining the impact of auditory stimulation on spindle likelihood for young subjects, whereas for older participants the temporal lag since the last spindle was a better predictor of spindle likelihood. ","['twenty-one young and seventeen older subjects', 'young and older adults', 'young and older participants']","['Closed loop auditory stimulation (CLAS', 'CLAS during slow-wave-sleep in two experimental conditions: sham and auditory stimulation']",[],"[{'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0001164', 'cui_str': 'Stimulation, Auditory'}, {'cui': 'C0234451', 'cui_str': 'Sleep, Slow-Wave'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]",[],21.0,0.0317339,"Click-phase on the SO wave was the main factor determining the impact of auditory stimulation on spindle likelihood for young subjects, whereas for older participants the temporal lag since the last spindle was a better predictor of spindle likelihood. ","[{'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Navarrete', 'Affiliation': 'Cardiff University Brain Research Imaging Centre (CUBRIC), School of Psychology, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Jules', 'Initials': 'J', 'LastName': 'Schneider', 'Affiliation': 'School of Biological Sciences, University of Manchester, Manchester, UK.'}, {'ForeName': 'Hong-Viet V', 'Initials': 'HV', 'LastName': 'Ngo', 'Affiliation': 'School of Psychology, University of Birmingham, Edgbaston, Birmingham, UK.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Valderrama', 'Affiliation': 'Department of Biomedical Engineering, University of Los Andes, Bogotá, Colombia.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Casson', 'Affiliation': 'School of Electrical and Electronic Engineering, University of Manchester, Manchester, UK.'}, {'ForeName': 'Penelope A', 'Initials': 'PA', 'LastName': 'Lewis', 'Affiliation': 'Cardiff University Brain Research Imaging Centre (CUBRIC), School of Psychology, Cardiff University, Cardiff, UK.'}]",Sleep,['10.1093/sleep/zsz315'] 4208,31407593,"Investigating the Effect of Use and Social Cues in Food Advertisements on Attention, Feelings of Social Support, and Purchase Intention.","In an effort to understand how different types of food cues in food ads are automatically encouraging unhealthy eating behaviors, the current study examined how the presence of actual food consumption behaviors (use cues) and presence of multiple individuals indorsing food products (social cues) in fast food ads would influence individual attentional and behavioral responses. A use cue (2) x social cue (2) x repetition (3) fully within-subjects factorial design experiment with young adults ( N = 164) was conducted. Findings demonstrated that participants paid greater attention to the fast food ads which contained multiple people (group cue) eating the advertised food products (use cue) when compared to other types of fast food ads. In addition, participants also self-reported greater social support and purchase intention when seeing use and group cues in ads. Understanding how these cues function in food advertising to encourage unhealthy eating may help health practitioners and individuals create more helpful intervention strategies. Further, applying these marketing tactics to ads for food products that are healthier (i.e., less energy dense and more nutrient dense) may help to maximize healthy food palatability, thereby increasing motivation for viewers to make autonomous decisions about eating healthier.",2020,Findings demonstrated that participants paid greater attention to the fast food ads which contained multiple people (group cue) eating the advertised food products (use cue) when compared to other types of fast food ads.,['with young adults ( N =\xa0164'],['cue (2) x social cue (2) x repetition (3) fully within-subjects factorial design experiment'],"['Attention, Feelings of Social Support, and Purchase Intention', 'social support and purchase intention']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0010439', 'cui_str': 'Cues'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0037438'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",,0.0158914,Findings demonstrated that participants paid greater attention to the fast food ads which contained multiple people (group cue) eating the advertised food products (use cue) when compared to other types of fast food ads.,"[{'ForeName': 'Jiawei', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'School of Journalism and Communication, Jinan University.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Bailey', 'Affiliation': 'School of Communication, Florida State University.'}]",Health communication,['10.1080/10410236.2019.1654174'] 4209,32129263,A Comparison of Hypertonic Saline and Mannitol on Intraoperative Brain Relaxation in Patients with Raised Intracranial Pressure during Supratentorial Tumors Resection: A Randomized Control Trial.,"Introduction Hyperosmotic agents are used to decrease intracranial pressure (ICP). We aim to compare the effect of euvolemic solutions of 3% hypertonic saline (HTS) and 20% mannitol on intraoperative brain relaxation in patients with clinical or radiological evidence of raised ICP undergoing surgery for supratentorial tumors. Materials and Methods A. prospective double-blind study was conducted on 30 patients randomized into two equal groups. Each patient was administered 5 ml/kg of either 20% mannitol or 3% HTS over 15 minutes (min) after skin incision. Hemodynamic data, brain relaxation and serum electrolyte levels were recorded. Results Intraoperative brain relaxation was comparable between the two groups. There was a statistically significant difference in the mean arterial pressures (MAPs) between the two groups after one minutes (min) with a greater degree of decrease in blood pressure recorded in the mannitol group (P = 0.041). MAP with mannitol was significantly lower than the preinduction value after 75 min of administration of drug (P = 0.003). Urine output was significantly higher in the mannitol group (P = 0.00). Administration of HTS was associated with a transient increase in serum sodium concentrations, which was statistically significant but returned to normal within 48 h (P < 0.001). Conclusions Both mannitol and HTS provided adequate intraoperative brain relaxation. On the contrary, there was no statistically significant fall in blood pressure with HTS. Thus, we advocate the use of HTS over mannitol as it maintains better hemodynamic stability.",2020,Urine output was significantly higher in the mannitol group (P = 0.00).,"['Patients with Raised Intracranial Pressure during Supratentorial Tumors Resection', '30 patients randomized into two equal groups', 'patients with clinical or radiological evidence of raised ICP undergoing surgery for supratentorial tumors']","['euvolemic solutions of 3% hypertonic saline (HTS) and 20% mannitol', 'mannitol and HTS', 'Hypertonic Saline and Mannitol', 'HTS', '20% mannitol or 3% HTS', 'HTS over mannitol']","['Urine output', 'Intraoperative brain relaxation', 'blood pressure with HTS', 'Hemodynamic data, brain relaxation and serum electrolyte levels', 'intracranial pressure (ICP', 'intraoperative brain relaxation', 'Intraoperative Brain Relaxation', 'serum sodium concentrations', 'mean arterial pressures (MAPs', 'blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0151740', 'cui_str': 'Intracranial Pressure Increase'}, {'cui': 'C0038874', 'cui_str': 'Supratentorial Tumors'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0442818', 'cui_str': 'Raised (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0036085', 'cui_str': 'Sodium Chloride Solution, Hypertonic'}, {'cui': 'C0887166', 'cui_str': '(L)-Mannitol'}]","[{'cui': 'C1287298', 'cui_str': 'UO - Urine output'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1287347', 'cui_str': 'Finding of serum electrolyte levels (finding)'}, {'cui': 'C0021880', 'cui_str': 'Subarachnoid Pressure'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0024779', 'cui_str': 'Map'}]",30.0,0.134862,Urine output was significantly higher in the mannitol group (P = 0.00).,"[{'ForeName': 'Ankush', 'Initials': 'A', 'LastName': 'Singla', 'Affiliation': 'Department of Anaesthesia, Adesh Medical College, Bhathinda, Punjab, India.'}, {'ForeName': 'Preethy J', 'Initials': 'PJ', 'LastName': 'Mathew', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Jangra', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Sunil K', 'Initials': 'SK', 'LastName': 'Gupta', 'Affiliation': 'Department of Neurosurgery, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Shiv Lal', 'Initials': 'SL', 'LastName': 'Soni', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}]",Neurology India,['10.4103/0028-3886.279671'] 4210,29752179,"The effect of eicosapentaenoic and docosahexaenoic acids on physical function, exercise, and joint replacement in patients with coronary artery disease: A secondary analysis of a randomized clinical trial.","BACKGROUND Poor physical function impairs fitness and exercise and is associated with worse cardiovascular outcomes and all-cause mortality. Joint pain and stiffness limit physical function. OBJECTIVE To determine if eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) supplementation improves physical function and exercise in coronary artery disease (CAD) patients. METHODS A total of 291 subjects with stable CAD were randomized to either Lovaza (1.86 g of EPA and 1.5 g of DHA daily) or no Lovaza (control) for 1 year. Change in pain, stiffness, and physical function was assessed by the Western Ontario and McMaster Universities Arthritis Index. Minutes of exercise per week were recorded, and musculoskeletal events were reported. RESULTS Mean age (standard deviation) was 63.3 (7.6) years. In the intention-to-treat analysis, compared with controls, those on Lovaza had better physical function (mean difference, -11.0%, 95% confidence interval [CI] -18.5% to -3.5%, P = .004), better total Western Ontario and McMaster Universities Arthritis Index scores (mean difference, -9.8%, 95% CI -16.6% to -3.0%, P = .005), more exercise per week (135 minutes vs 197 minutes, respectively, P = .028), and less joint replacement (11 vs 1, respectively, P = .002). Pain and stiffness showed a trend toward significance (P = .06). The per-protocol analysis also showed less stiffness compared with controls (mean difference, -11.5%, 95% CI -22.9% to -0.1%, P = .048). CONCLUSION High-dose EPA and DHA may benefit CAD patients by preserving physical function, increasing amount of exercise, and reducing joint replacement. EPA and DHA may be a safe preventative strategy against musculoskeletal symptoms in CAD patients.",2018,".005), more exercise per week (135 minutes vs 197 minutes, respectively, P = .028), and less joint replacement (11 vs 1, respectively, P = ","['CAD patients', 'coronary artery disease (CAD) patients', 'Mean age (standard deviation) was 63.3 (7.6) years', 'patients with coronary artery disease', '291 subjects with stable CAD']","['EPA and DHA', 'EPA and 1.5\xa0g of DHA daily) or no Lovaza (control', 'eicosapentaenoic and docosahexaenoic acids', 'eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) supplementation', 'Lovaza']","['physical function', 'total Western Ontario and McMaster Universities Arthritis Index scores', 'joint replacement', 'Pain and stiffness', 'Change in pain, stiffness, and physical function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}]","[{'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0912903', 'cui_str': 'Lovaza'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0556102', 'cui_str': 'DHA - Docosahexaenoic acid supplementation'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C3666006', 'cui_str': 'Arthritis (SMQ)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0185317', 'cui_str': 'Joint Replacement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",291.0,0.274838,".005), more exercise per week (135 minutes vs 197 minutes, respectively, P = .028), and less joint replacement (11 vs 1, respectively, P = ","[{'ForeName': 'Abdulhamied', 'Initials': 'A', 'LastName': 'Alfaddagh', 'Affiliation': 'Department of Internal Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Tarec K', 'Initials': 'TK', 'LastName': 'Elajami', 'Affiliation': 'Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Saleh', 'Affiliation': 'Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Elajami', 'Affiliation': 'Beirut Arab University, Faculty of Medicine, Beirut, Lebanon.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Bistrian', 'Affiliation': 'Department of Internal Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Francine K', 'Initials': 'FK', 'LastName': 'Welty', 'Affiliation': 'Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. Electronic address: fwelty@bidmc.harvard.edu.'}]",Journal of clinical lipidology,['10.1016/j.jacl.2018.03.080'] 4211,32123315,Phase 2 trial of monoamine oxidase inhibitor phenelzine in biochemical recurrent prostate cancer.,"PURPOSE Monoamine oxidase A (MAOA) influences prostate cancer growth and metastasis in pre-clinical models. We examined effects of phenelzine (a monoamine oxidase inhibitor) in patients with biochemical recurrent castrate-sensitive prostate cancer. MATERIALS AND METHODS An open-label single arm clinical trial enrolled subjects with biochemical recurrent prostate cancer defined by PSA ≥ 0.4 ng/ml (post prostatectomy) or PSA ≥ 2 ng/ml above nadir (post-radiation therapy); no evidence of metastasis on imaging; and normal androgen levels. Subjects received phenelzine 30 mg orally twice daily. Mood symptoms were assessed with the hospital anxiety depression score (HADS) questionnaire. The primary endpoint was the proportion of patients who achieved a PSA decline of ≥50% from baseline. RESULTS Characteristics of the 20 eligible patients enrolled included: mean ± SD age 66.9 ± 4.8 years and PSA 4.7 ± 5.8 ng/dl. Maximal PSA declines ≥30% and ≥50% were observed in 25% (n = 5/20) and 10% (n = 2/20) of subjects, respectively. At 12 weeks, 17 subjects remained on treatment with PSA declines ≥30% and ≥50% of 24% (n = 4/17) and 6% (n = 1/17), respectively. Common toxicities observed included dizziness (grade 1 = 45%, grade 2 = 35%), hypertension (grade ≥ 2 = 30%), and edema (grade 1 = 25%, grade 2 = 10%). There was one episode of grade 4 hypertension (cycle 4) and two episodes of grade 3 syncope (cycle 12 and cycle 14) requiring treatment discontinuation. HADS questionnaires demonstrated a significant decrease in anxiety with no change in depressive symptoms on treatment. CONCLUSIONS Phenelzine demonstrated efficacy in patients with biochemical recurrent castrate-sensitive prostate cancer. Most treatment-related toxicities were mild, but rare significant and reversible cardiovascular toxicities were observed. Therapies directed at MAOA may represent a new avenue for treatment in patients with recurrent prostate cancer.",2021,"HADS questionnaires demonstrated a significant decrease in anxiety with no change in depressive symptoms on treatment. ","['subjects with biochemical recurrent prostate cancer defined by PSA\u2009≥\u20090.4\u2009ng/ml (post prostatectomy) or PSA\u2009≥\u20092\u2009ng/ml above nadir (post-radiation therapy); no evidence of metastasis on imaging; and normal androgen levels', 'biochemical recurrent prostate cancer', 'patients with recurrent prostate cancer', 'patients with biochemical recurrent castrate-sensitive prostate cancer', '20 eligible patients enrolled included: mean\u2009±\u2009SD age 66.9\u2009±\u20094.8 years and PSA 4.7\u2009±\u20095.8\u2009ng/dl']","['Monoamine oxidase A (MAOA', 'phenelzine 30\u2009mg orally twice daily', 'phenelzine (a monoamine oxidase inhibitor', 'Phenelzine', 'monoamine oxidase inhibitor phenelzine']","['Mood symptoms', 'anxiety', 'dizziness', 'hypertension', 'Maximal PSA declines', 'proportion of patients who achieved a PSA decline', 'reversible cardiovascular toxicities', 'toxicities', 'depressive symptoms', 'hospital anxiety depression score (HADS) questionnaire']","[{'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}, {'cui': 'C0445177', 'cui_str': 'Post-radiation (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332125', 'cui_str': 'No evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0919646', 'cui_str': 'Androgen level'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517765', 'cui_str': '4.8 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439274', 'cui_str': 'ng/dL'}]","[{'cui': 'C0026455', 'cui_str': 'MAO-A'}, {'cui': 'C0031392', 'cui_str': 'Phenelzine'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C4521320', 'cui_str': 'Monoamine oxidase inhibitor (disposition)'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205343', 'cui_str': 'Reversible (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder (disorder)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",20.0,0.0681233,"HADS questionnaires demonstrated a significant decrease in anxiety with no change in depressive symptoms on treatment. ","[{'ForeName': 'Mitchell E', 'Initials': 'ME', 'LastName': 'Gross', 'Affiliation': 'Lawrence J. Ellison Institute for Transformative Medicine, University of Southern California, Los Angeles, CA, USA. mitchell.gross@usc.edu.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Agus', 'Affiliation': 'Lawrence J. Ellison Institute for Transformative Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Tanya B', 'Initials': 'TB', 'LastName': 'Dorff', 'Affiliation': 'Department of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Jacek K', 'Initials': 'JK', 'LastName': 'Pinski', 'Affiliation': 'Department of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Quinn', 'Affiliation': 'Department of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Castellanos', 'Affiliation': 'Lawrence J. Ellison Institute for Transformative Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Gilmore', 'Affiliation': 'Lawrence J. Ellison Institute for Transformative Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Jean C', 'Initials': 'JC', 'LastName': 'Shih', 'Affiliation': 'Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA. jcshih@usc.edu.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-020-0211-9'] 4212,32057570,Bacille Calmette-Guérin vaccination at birth and differential white blood cell count in infancy. A randomised clinical trial.,"BACKGROUND The Bacille Calmette-Guérin (BCG) vaccine against tuberculosis (TB) may have beneficial non-specific effects (NSEs) beyond the protection against TB. This may be related to modifications of the innate immune system. We investigated the effect of BCG at birth on differential white blood cell (WBC) count in healthy, Danish infants. METHOD The Danish Calmette Study randomised newborns to BCG at birth (Danish strain 1331, Statens Serum Institut) or no intervention. A sub-group of infants had blood samples collected 4 days after randomisation (n = 161), and at age 3 months (n = 152) and 13 months (n = 300). We evaluated the effect of BCG on WBC differential count (total leucocytes, lymphocytes, monocytes, eosinophil, neutrophil and basophil granulocytes (10 9 cells/L)) measured in peripheral blood. RESULTS Overall, we found no effect of BCG on differential WBC counts at any time point. CONCLUSION BCG at birth did not affect WBC count in our cohort of healthy, Danish infants.",2020,"Overall, we found no effect of BCG on differential WBC counts at any time point. ","['infancy', 'healthy, Danish infants']","['Bacille Calmette-Guérin vaccination', 'BCG', 'Bacille Calmette-Guérin (BCG) vaccine against tuberculosis (TB']","['differential white blood cell (WBC) count', 'WBC differential count (total leucocytes, lymphocytes, monocytes, eosinophil, neutrophil and basophil granulocytes (10 9 cells/L)) measured in peripheral blood', 'differential WBC counts', 'WBC count']","[{'cui': 'C0231330', 'cui_str': 'Infancy - period'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0085957', 'cui_str': 'BCG'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}]","[{'cui': 'C0162401', 'cui_str': 'Leukocyte Count, Differential'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C4316898', 'cui_str': 'Basophil, segmented (cell)'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0347983', 'cui_str': 'cells/liter'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}]",,0.0738357,"Overall, we found no effect of BCG on differential WBC counts at any time point. ","[{'ForeName': 'Signe Kjeldgaard', 'Initials': 'SK', 'LastName': 'Jensen', 'Affiliation': 'Department of Pediatrics, Copenhagen University Hospital, Hvidovre, Denmark. Electronic address: signe.jensen@dbac.dk.'}, {'ForeName': 'Trine Mølbæk', 'Initials': 'TM', 'LastName': 'Jensen', 'Affiliation': 'Department of Pediatrics, Copenhagen University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Nina Marie', 'Initials': 'NM', 'LastName': 'Birk', 'Affiliation': 'Department of Pediatrics, Copenhagen University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Lone Graff', 'Initials': 'LG', 'LastName': 'Stensballe', 'Affiliation': 'The Department of Pediatrics and Adolescent Medicine, The Juliane Marie Center, Rigshospitalet, Copenhagen University Hospital, Denmark.'}, {'ForeName': 'Christine Stabell', 'Initials': 'CS', 'LastName': 'Benn', 'Affiliation': 'Research Center for Vitamins and Vaccines (CVIVA), Statens Serum Institut, Denmark; Odense Patient Data Explorative Network (OPEN), Odense University Hospital/Department of Clinical Research, University of Southern Denmark, DK-5000 Odense, Denmark.'}, {'ForeName': 'Kristoffer Jarlov', 'Initials': 'KJ', 'LastName': 'Jensen', 'Affiliation': 'Research Center for Vitamins and Vaccines (CVIVA), Statens Serum Institut, Denmark; Department of Health Technology, Technical University of Denmark, Kgs. Lyngby, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Pryds', 'Affiliation': 'Department of Pediatrics, Copenhagen University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Dorthe Lisbeth', 'Initials': 'DL', 'LastName': 'Jeppesen', 'Affiliation': 'Department of Pediatrics, Copenhagen University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Thomas Nørrelykke', 'Initials': 'TN', 'LastName': 'Nissen', 'Affiliation': 'Department of Pediatrics, Copenhagen University Hospital, Hvidovre, Denmark.'}]",Vaccine,['10.1016/j.vaccine.2020.02.006'] 4213,31564516,"The impact of intensified clinical care on glycaemic control in patients with type 2 diabetes at Khayelitsha Community Health Centre, South Africa: Quasi-experimental study.","AIM The aim was to evaluate the effect on glycaemic control of more intensive care for patients with very uncontrolled type-2 diabetes (HbA1c>10%) at Khayelitsha Community Health Centre, South Africa. METHODS A pragmatic, quasi-experimental study. Patients with HBA1c>10% were consecutively selected into a 6-month programme of intensified care involving monthly visits to a doctor, diabetes group education, escalation of treatment, and more frequent HbA1c testing by either point-of-care (POC) or laboratory. Participants were their own controls in a retrospective analysis of usual care during the previous year. RESULTS At baseline 236 patients had a mean HbA1c of 12.1%. The mean difference in HbA1c in the intervention group was -1.1% (p<0.001). The intervention group were exposed to group diabetes education (100% vs 0%), more visits (3.8 vs 3.2, p<0.001), more HbA1c tests (2.2 vs 0.9, p<0.001). There was no difference in increased dose of insulin between the groups or between POC and standard laboratory intervention sub-groups. CONCLUSION The introduction of group diabetes education was the most likely explanation for improved glycaemic control in this poor, under-resourced, public sector, peri-urban setting. The study demonstrates a feasible approach to improving diabetes care in the South African context.",2020,The mean difference in HbA1c in the intervention group was -1.1% (p<0.001).,"['patients with type 2 diabetes at Khayelitsha Community Health Centre, South Africa', 'Participants were their own controls in a retrospective analysis of usual care during the previous year', 'patients with very uncontrolled type-2 diabetes (HbA1c>10%) at Khayelitsha Community Health Centre, South Africa', 'Patients with HBA1c>10% were consecutively selected into a 6-month programme of intensified care involving monthly visits to a doctor, diabetes group education, escalation of treatment, and more frequent HbA1c testing by either point-of-care (POC) or laboratory']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0150375', 'cui_str': 'Group instruction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]",[],[],236.0,0.041459,The mean difference in HbA1c in the intervention group was -1.1% (p<0.001).,"[{'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Allerton', 'Affiliation': 'Division of Family Medicine and Primary Care, Faculty of Medicine and Health Sciences, Stellenbosch University, Box 241, Cape Town, 8000, South Africa. Electronic address: joshallerton@gmail.com.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Mash', 'Affiliation': 'Division of Family Medicine and Primary Care, Faculty of Medicine and Health Sciences, Stellenbosch University, Box 241, Cape Town, 8000, South Africa. Electronic address: rm@sun.ac.za.'}]",Primary care diabetes,['10.1016/j.pcd.2019.08.006'] 4214,32124216,Feasibility of Postoperative Home Monitoring Using Video Consultation and Vital Sign Monitoring of Bariatric Patients.,"RATIONALE The length of hospital stay after bariatric surgery has decreased rapidly in recent years to an average of 1 day (one midnight). The transition from a controlled hospital environment to home environment may be a big step for patients. For these patients, home monitoring can be a substitute. METHODS A pilot study of 84 morbidly obese patients undergoing either laparoscopic Roux-Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LGS) was performed. Home monitoring consisted of daily contact via video consultation and measurement of vital signs at home. The primary outcome was feasibility of home monitoring. Secondary outcomes were complications and patient satisfaction measured with a questionnaire (PSQ-18). RESULTS In 77 of the 84 patients (92%), videoconference was possible on day 1, 74 patients (88%) on day 2 and 76 patients (90%) on day 3. Four patients (5%) were never reached. On day 1, 52 patients (62%) performed all instructed measurements, on day 2, 49 patients (58%) and on day 3, 63 patients (75%). Only 47 out of 84 patients (56%) measured the instructed amount of times on all 3 days. High satisfaction rates were reported in the patients receiving home monitoring. CONCLUSION Our first experience with home monitoring was disappointing since home monitoring of vital signs had poor compliance and not all patients were able to use the application. Further refinement of the home monitoring tool is needed to increase compliance and utility of the tool.",2020,"In 77 of the 84 patients (92%), videoconference was possible on day 1, 74 patients (88%) on day 2 and 76 patients (90%) on day 3.","['84 morbidly obese patients undergoing either', 'Bariatric Patients']","['laparoscopic Roux-Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LGS', 'videoconference']","['complications and patient satisfaction measured with a questionnaire (PSQ-18', 'High satisfaction rates', 'feasibility of home monitoring']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}]","[{'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C1450049', 'cui_str': 'Videoconference'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]",84.0,0.0208628,"In 77 of the 84 patients (92%), videoconference was possible on day 1, 74 patients (88%) on day 2 and 76 patients (90%) on day 3.","[{'ForeName': 'L M G', 'Initials': 'LMG', 'LastName': 'Nijland', 'Affiliation': 'Department of Surgery, OLVG West, Jan Tooropstraat 164, 1061 AE, Amsterdam, The Netherlands. l.m.g.nijland@olvg.nl.'}, {'ForeName': 'R N', 'Initials': 'RN', 'LastName': 'van Veen', 'Affiliation': 'Department of Surgery, OLVG West, Jan Tooropstraat 164, 1061 AE, Amsterdam, The Netherlands.'}, {'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Ruys', 'Affiliation': 'Department of Surgery, OLVG West, Jan Tooropstraat 164, 1061 AE, Amsterdam, The Netherlands.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'van Veldhuisen', 'Affiliation': 'Department of Surgery, OLVG West, Jan Tooropstraat 164, 1061 AE, Amsterdam, The Netherlands.'}, {'ForeName': 'T H', 'Initials': 'TH', 'LastName': 'Geerdink', 'Affiliation': 'Department of Surgery, OLVG West, Jan Tooropstraat 164, 1061 AE, Amsterdam, The Netherlands.'}, {'ForeName': 'S M M', 'Initials': 'SMM', 'LastName': 'de Castro', 'Affiliation': 'Department of Surgery, OLVG West, Jan Tooropstraat 164, 1061 AE, Amsterdam, The Netherlands.'}]",Obesity surgery,['10.1007/s11695-020-04500-9'] 4215,32115759,"Cilofexor, a Nonsteroidal FXR Agonist, in Patients With Noncirrhotic NASH: A Phase 2 Randomized Controlled Trial.","BACKGROUND AND AIMS We evaluated the safety and efficacy of cilofexor (formerly GS-9674), a small-molecule nonsteroidal agonist of farnesoid X receptor, in patients with nonalcoholic steatohepatitis (NASH). APPROACH AND RESULTS In this double-blind, placebo-controlled, phase 2 trial, 140 patients with noncirrhotic NASH, diagnosed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) ≥8% and liver stiffness ≥2.5 kPa by magnetic resonance elastography (MRE) or historical liver biopsy, were randomized to receive cilofexor 100 mg (n = 56), 30 mg (n = 56), or placebo (n = 28) orally once daily for 24 weeks. MRI-PDFF, liver stiffness by MRE and transient elastography, and serum markers of fibrosis were measured at baseline and week 24. At baseline, median MRI-PDFF was 16.3% and MRE-stiffness was 3.27 kPa. At week 24, patients receiving cilofexor 100 mg had a median relative decrease in MRI-PDFF of -22.7%, compared with an increase of 1.9% in those receiving placebo (P = 0.003); the 30-mg group had a relative decrease of -1.8% (P = 0.17 vs. placebo). Declines in MRI-PDFF of ≥30% were experienced by 39% of patients receiving cilofexor 100 mg (P = 0.011 vs. placebo), 14% of those receiving cilofexor 30 mg (P = 0.87 vs. placebo), and 13% of those receiving placebo. Serum gamma-glutamyltransferase, C4, and primary bile acids decreased significantly at week 24 in both cilofexor treatment groups, whereas significant changes in Enhanced Liver Fibrosis scores and liver stiffness were not observed. Cilofexor was generally well-tolerated. Moderate to severe pruritus was more common in patients receiving cilofexor 100 mg (14%) than in those receiving cilofexor 30 mg (4%) and placebo (4%). CONCLUSIONS Cilofexor for 24 weeks was well-tolerated and provided significant reductions in hepatic steatosis, liver biochemistry, and serum bile acids in patients with NASH. ClinicalTrials.gov No. NCT02854605.",2020,"Serum gamma-glutamyltransferase, C4, and primary bile acids decreased significantly at week 24 in both cilofexor treatment groups, whereas significant changes in ELF and liver stiffness were not observed.","['patients with NASH', 'patients with nonalcoholic steatohepatitis (NASH', '140 non-cirrhotic patients with NASH diagnosed by', 'Non-Cirrhotic Patients with Nonalcoholic Steatohepatitis']","['placebo', 'cilofexor (formerly GS-9674', 'Cilofexor', 'magnetic resonance elastography (MRE', 'cilofexor', 'magnetic resonance imaging-proton density fat fraction (MRI-PDFF']","['median MRI-PDFF', 'MRI-PDFF, liver stiffness by MRE and transient elastography, and serum markers of fibrosis', 'tolerated', 'MRI-PDFF', 'ELF and liver stiffness', 'Moderate to severe pruritus', 'hepatic steatosis, liver biochemistry, and serum bile acids', 'Serum gamma-glutamyltransferase, C4, and primary bile acids', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic Steatohepatitis'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0439687', 'cui_str': 'Non-cirrhotic (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1518156', 'cui_str': 'Magnetic Resonance Elastography'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0033727', 'cui_str': 'Hydrogen Ions'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C2748260', 'cui_str': 'Transient elastography'}, {'cui': 'C0162491', 'cui_str': 'Serum Markers'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C2711227', 'cui_str': 'Liver Steatosis'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005390', 'cui_str': 'Bile Acids'}, {'cui': 'C0202035', 'cui_str': 'Gamma glutamyl transferase measurement (procedure)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",140.0,0.382122,"Serum gamma-glutamyltransferase, C4, and primary bile acids decreased significantly at week 24 in both cilofexor treatment groups, whereas significant changes in ELF and liver stiffness were not observed.","[{'ForeName': 'Keyur', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Harrison', 'Affiliation': 'Pinnacle Clinical Research, San Antonio, TX.'}, {'ForeName': 'Magdy', 'Initials': 'M', 'LastName': 'Elkhashab', 'Affiliation': 'Toronto Liver Center, Toronto, ON, Canada.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Trotter', 'Affiliation': 'Texas Digestive Disease Consultants, Dallas, TX.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Herring', 'Affiliation': 'Quality Medical Research, Nashville, TN.'}, {'ForeName': 'Sergio E', 'Initials': 'SE', 'LastName': 'Rojter', 'Affiliation': 'Ruane Clinical Research, Los Angeles, CA.'}, {'ForeName': 'Zeid', 'Initials': 'Z', 'LastName': 'Kayali', 'Affiliation': 'Inland Empire Liver Foundation, Rialto, CA.'}, {'ForeName': 'Vincent Wai-Sun', 'Initials': 'VW', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Greenbloom', 'Affiliation': 'Toronto Digestive Disease Associates, Woodbridge, ON, Canada.'}, {'ForeName': 'Saumya', 'Initials': 'S', 'LastName': 'Jayakumar', 'Affiliation': 'University of California San Diego, San Diego, CA.'}, {'ForeName': 'Mitchell L', 'Initials': 'ML', 'LastName': 'Shiffman', 'Affiliation': 'Bon Secours Mercy Health, Richmond, VA.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Freilich', 'Affiliation': 'Kansas City Research Institute, Kansas City, MO.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lawitz', 'Affiliation': 'Texas Liver Institute, University of Texas Health San Antonio, San Antonio, TX.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Gane', 'Affiliation': 'Liver Unit, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Eliza', 'Initials': 'E', 'LastName': 'Harting', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Billin', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Chuhan', 'Initials': 'C', 'LastName': 'Chung', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'C Stephen', 'Initials': 'CS', 'LastName': 'Djedjos', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'G Mani', 'Initials': 'GM', 'LastName': 'Subramanian', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Myers', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Middleton', 'Affiliation': 'University of California San Diego, San Diego, CA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Rinella', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, IL.'}, {'ForeName': 'Mazen', 'Initials': 'M', 'LastName': 'Noureddin', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, CA.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.31205'] 4216,32044419,Randomized phase-III-trial of concurrent chemoradiation for locally advanced head and neck cancer comparing dose reduced radiotherapy with paclitaxel/cisplatin to standard radiotherapy with fluorouracil/cisplatin: The PacCis-trial.,"BACKGROUND AND PURPOSE This multicenter, phase 3 trial investigates whether the incorporation of concurrent paclitaxel and cisplatin together with a reduced total dose of radiotherapy is superior to standard fluorouracil-cisplatin based CRT. MATERIALS AND METHODS Patients with SCCHN, stage III-IVB, were randomized to receive paclitaxel/cisplatin (PacCis)-CRT (arm A; paclitaxel 20 mg/m 2 on days 2, 5, 8, 11 and 25, 30, 33, 36; cisplatin 20 mg/m 2 , days 1-4 and 29-32; RT to a total dose of 63.6 Gy) or fluorouracil/cisplatin (CisFU)-CRT (arm B; fluorouracil 600 mg/m 2 ; cisplatin 20 mg/m 2 , days 1-5 and 29-33; RT: 70.6 Gy). Endpoint was 3-year-disease free survival (3y-DFS). RESULTS A total of 221 patients were enrolled between 2010 and 2015. With a median follow-up of 3.7 years, 3y-DFS in the CisFU arm and PacCis arm was 58.2% and 48.4%, respectively (HR 0.82, 95% CI 0.56-1.21, p = 0.52). The 3y-OS amounted to 64.6% in the CisFU arm, and to 59.2% in the PacCis arm (HR 0.82, 95% CI 0.54-1.24, p = 0.43). In the subgroup of p16-positive oropharyngeal carcinomas, 3y-DFS and 3y-OS was 84.6% vs 83.9% (p = 0.653), and 92.3% vs. 83.5% (p = 0.76) in arm A and B, respectively. Grade 3-4 hematological toxicities were significantly reduced in arm A (anemia, p = 0.01; leukocytopenia, p = 0.003), whereas grade 3 infections were reduced in arm B (p = 0.01). CONCLUSION Paclitaxel/cisplatin-CRT with a reduced RT-dose is not superior to standard fluorouracil/cisplatin-CRT. Subgroup analyses indicate that a reduced radiation dose seems to be sufficient for p16+ oropharyngeal cancer or non-smokers. CLINICAL TRIAL INFORMATION NCT01126216; EudraCT Number 2005-003484-23.",2020,"Subgroup analyses indicate that a reduced radiation dose seems to be sufficient for p16+ oropharyngeal cancer or non-smokers. CLINICAL TRIAL INFORMATION NCT01126216; EudraCT Number 2005-003484-23.","['locally advanced head and neck cancer', '221 patients were enrolled between 2010 and 2015', 'Patients with SCCHN, stage III-IVB']","['paclitaxel and cisplatin', 'concurrent chemoradiation', 'radiotherapy with paclitaxel/cisplatin to standard radiotherapy with fluorouracil/cisplatin', 'fluorouracil-cisplatin based CRT', 'fluorouracil/cisplatin (CisFU)-CRT (arm B; fluorouracil 600\xa0mg/m 2 ; cisplatin', 'paclitaxel/cisplatin (PacCis)-CRT (arm A', 'Paclitaxel/cisplatin-CRT', 'fluorouracil/cisplatin-CRT', 'cisplatin', 'radiotherapy']","['leukocytopenia', 'Grade 3-4 hematological toxicities', '3-year-disease free survival', 'grade 3 infections']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C3816748', 'cui_str': '600'}]","[{'cui': 'C0023530', 'cui_str': 'Leukocytopenia'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",221.0,0.150278,"Subgroup analyses indicate that a reduced radiation dose seems to be sufficient for p16+ oropharyngeal cancer or non-smokers. CLINICAL TRIAL INFORMATION NCT01126216; EudraCT Number 2005-003484-23.","[{'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Fietkau', 'Affiliation': 'University Hospitals of Erlangen, Germany. Electronic address: Rainer.Fietkau@uk-erlangen.de.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Hecht', 'Affiliation': 'University Hospitals of Erlangen, Germany. Electronic address: Markus.Hecht@uk-erlangen.de.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Hofner', 'Affiliation': 'Institut für Medizininformatik, Biometrie und Epidemiologie, FAU Erlangen-Nürnberg, Germany. Electronic address: Benjamin.Hofner@pei.de.'}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Lubgan', 'Affiliation': 'University Hospitals of Erlangen, Germany. Electronic address: dorota.lubgan@uk-erlangen.de.'}, {'ForeName': 'Heinrich', 'Initials': 'H', 'LastName': 'Iro', 'Affiliation': 'University Hospitals of Erlangen, Germany. Electronic address: heinrich.iro@uk-erlangen.de.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Gefeller', 'Affiliation': 'Institut für Medizininformatik, Biometrie und Epidemiologie, FAU Erlangen-Nürnberg, Germany. Electronic address: olaf.gefeller@imbe.med.uni-erlangen.de.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Rödel', 'Affiliation': 'J.W. Goethe University Hospital Frankfurt, Frankfurt am Main, Germany. Electronic address: claus.roedel@kgu.de.'}, {'ForeName': 'Matthias G', 'Initials': 'MG', 'LastName': 'Hautmann', 'Affiliation': 'University Hospitals of Regensburg, Germany. Electronic address: matthias.hautmann@ukr.de.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Kölbl', 'Affiliation': 'University Hospitals of Regensburg, Germany. Electronic address: oliver.koelbl@ukr.de.'}, {'ForeName': 'Attila', 'Initials': 'A', 'LastName': 'Salay', 'Affiliation': 'Brüderkrankenhaus St. Josef, Paderborn, Germany. Electronic address: a.salay@bk-paderborn.de.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rübe', 'Affiliation': 'University of Saarland, Homburg, Germany. Electronic address: radioonkologie@uks.eu.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Melchior', 'Affiliation': 'University of Saarland, Homburg, Germany. Electronic address: patrick.melchior@uks.eu.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Breinl', 'Affiliation': 'Kliniken Pasing und Perlach, Munich, Germany. Electronic address: info@hno-arzt-gauting.de.'}, {'ForeName': 'Waldemar', 'Initials': 'W', 'LastName': 'Krings', 'Affiliation': 'Krankenhaus Maria Hilf, Mönchengladbach, Germany. Electronic address: waldemar.krings@mariahilf.de.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Gripp', 'Affiliation': 'University Hospitals of Düsseldorf, Germany. Electronic address: stephan.gripp@posteo.de.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Wollenberg', 'Affiliation': 'University of Schleswig-Holstein, Lübeck, Germany. Electronic address: barbara.wollenberg@uksh.de.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Keerl', 'Affiliation': 'Klinikum St. Elisabeth, Straubing, Germany. Electronic address: rainer.keerl@klinikum-straubing.de.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Schreck', 'Affiliation': 'Klinik am Eichert, Göppingen, Germany. Electronic address: ulrike.schreck@af-k.de.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Siekmeyer', 'Affiliation': 'MVZ Mutterhaus der Borromäerinnen, Trier, Germany. Electronic address: birgit.siekmeyer@mutterhaus.de.'}, {'ForeName': 'Gerhard G', 'Initials': 'GG', 'LastName': 'Grabenbauer', 'Affiliation': 'Coburg Cancer Center, Germany. Electronic address: gg@diacura.de.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Balermpas', 'Affiliation': 'J.W. Goethe University Hospital Frankfurt, Frankfurt am Main, Germany; University Hospital of Zurich, Switzerland. Electronic address: panagiotis.balermpas@usz.ch.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.01.016'] 4217,32077050,Influence of a Planning Intervention on Physical Activity Behavior: the Moderating Role of Intentions and Executive Functions in a Randomized Controlled Trial.,"BACKGROUND Planning and executive functions (EFs; inhibition, updating, shifting) are self-regulatory variables that help people to become and stay physically active. The aim of this study was to examine how and for whom a planning intervention affects physical activity (PA) behavior in the short term. Therefore, the mediating role of planning and the moderating role of intentions and EFs for the planning-behavior link were examined. METHOD In a randomized control trial with two treatment groups (planning group vs. control group) and two points of measurement (t1 and t2, 1 week apart), n = 200 students participated in both measurements. At t1, participants filled in standardized questionnaires assessing PA behavior, intention, and planning. Computer-based tests assessed the following EFs: inhibition, updating, and shifting. At t2, planning and PA behavior were measured again. Moderated mediation analyses were conducted. RESULTS A significant increase in PA between t1 and t2 was found for the planning group compared with the control group. Furthermore, planning cognitions significantly mediated the effect of the planning group on behavior and intention, as well as the EF updating moderated the association between planning and behavior. Forming plans was particularly beneficial for participants with high intentions and lower updating performance. CONCLUSION Planning enhances PA behavior, particularly when PA intention is high. Poor performance in updating can be compensated by planning since encouraging people to generate plans might facilitate automatic enactment of the behavior.",2020,"Furthermore, planning cognitions significantly mediated the effect of the planning group on behavior and intention, as well as the EF updating moderated the association between planning and behavior.",['participants with high intentions and lower updating performance'],"['Planning Intervention', 'planning intervention']","['physical activity (PA) behavior', 'PA', 'Physical Activity Behavior']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}]","[{'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",200.0,0.0249912,"Furthermore, planning cognitions significantly mediated the effect of the planning group on behavior and intention, as well as the EF updating moderated the association between planning and behavior.","[{'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Pfeffer', 'Affiliation': 'Medical School Hamburg, Faculty of Human Science, University of Applied Sciences and Medical University, Am Kaiserkai 1, 20457, Hamburg, Germany. ines.pfeffer@medicalschool-hamburg.de.'}, {'ForeName': 'Tilo', 'Initials': 'T', 'LastName': 'Strobach', 'Affiliation': 'Medical School Hamburg, Faculty of Human Science, University of Applied Sciences and Medical University, Am Kaiserkai 1, 20457, Hamburg, Germany.'}]",International journal of behavioral medicine,['10.1007/s12529-020-09864-x'] 4218,31365457,Impact of Two High-Volume Set Configuration Workouts on Resistance Training Outcomes in Recreationally Trained Men.,"ABSTRACT Karsten, DB, Fu, Y, Larumbe-Zabala, DE, Seijo, DM, and Naclerio, DF. Impact of two high-volume set configuration workouts on resistance training outcomes in recreationally trained men. J Strength Cond Res 35(2S): S136-S143, 2021-This study compared the effects of 2 weekly equalized by volume, loading zone and frequency resistance training designs using repetition to failure (RTF) or not to failure (NTF), on body composition, strength, and mechanical power. Based on individual baseline maximal strength, 18 recreationally resistance-trained men were pair-matched and consequently randomly assigned to an RTF (n = 9) or an NTF (n = 9) protocol. Subjects trained for 6 weeks using 2 different routines performed once per week (2 workouts per week). The RTF protocol comprised 4 sets of 10 repetitions per exercise with 2-minute rest and the NTF involved 8 sets of 5 repetitions per exercise with 1-minute rest. Subjects were tested pre- and post-intervention for maximal strength, upper- and lower-body power, fat-free mass, limb circumferences, and muscle thickness. Compared to baseline, both groups improved (p < 0.01) the maximal loads lifted in the bench press (RTF +9.44 ± 3.00 kg; NTF +7.22 ± 4.41 kg) and the squat (RTF +9.44 ± 4.64 kg; NTF +11.1 ± 10.33 kg) exercises, but only the NTF group increased (p < 0.05) upper-body power (+15.73 ± 12.59 W). Conversely, only the RTF group showed significant (p < 0.05) increase of the elbow flexors (+3.44 ± 5.11 mm) and vastus medialis (+3.28 ± 2.32 mm) thickness, whereas both groups enhanced anterior deltoid thickness (RTF +1.84 ± 1.68 mm, p < 0.05; NTF +2.76 ± 2.63 mm, p < 0.01). Although both training strategies improved strength, the RTF group elicited superior hypertrophic outcomes, whereas the NTF protocol resulted in more favorable improvements for upper-body power.",2021,"Compared to baseline, both groups improved (p < 0.01) the maximal loads lifted in the bench press (RTF +9.44 ± 3.00 kg; NTF +7.22 ± 4.41 kg) and the squat (RTF +9.44 ± 4.64 kg; NTF +11.1 ± 10.33 kg) exercises, but only the NTF group increased (p < 0.05) upper-body power (+15.73 ± 12.59 W).","['Recreationally Trained Men', '18 recreationally resistance-trained men', 'recreationally trained men']","['Two High-Volume Set Configuration Workouts', 'NTF', '2 weekly equalized by volume, loading zone and frequency resistance training designs using repetition to failure (RTF) or not to failure (NTF', 'RTF', 'J Strength Cond Res XX(X']","['Karsten, DB, Fu, Y, Larumbe-Zabala, DE, Seijo, DM, and Naclerio, DF', 'maximal loads lifted', 'anterior deltoid thickness', 'elbow flexors', 'body composition, strength, and mechanical power', 'resistance training outcomes', 'Resistance Training Outcomes']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0181620', 'cui_str': 'Lift'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]",,0.0274951,"Compared to baseline, both groups improved (p < 0.01) the maximal loads lifted in the bench press (RTF +9.44 ± 3.00 kg; NTF +7.22 ± 4.41 kg) and the squat (RTF +9.44 ± 4.64 kg; NTF +11.1 ± 10.33 kg) exercises, but only the NTF group increased (p < 0.05) upper-body power (+15.73 ± 12.59 W).","[{'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Karsten', 'Affiliation': 'Department of Exercise and Sport Science, LUNEX International University of Health, Exercise and Sports, Differdingen, Luxemburg.'}, {'ForeName': 'Yue Leon', 'Initials': 'YL', 'LastName': 'Fu', 'Affiliation': 'Department of Life and Sport Science, University of Greenwich, Medway, Kent, United Kingdom; and.'}, {'ForeName': 'Eneko', 'Initials': 'E', 'LastName': 'Larumbe-Zabala', 'Affiliation': 'Clinical Research Institute, Texas Tech University HSC, Lubbock, Texas.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Seijo', 'Affiliation': 'Department of Life and Sport Science, University of Greenwich, Medway, Kent, United Kingdom; and.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Naclerio', 'Affiliation': 'Department of Life and Sport Science, University of Greenwich, Medway, Kent, United Kingdom; and.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003163'] 4219,32065644,Efficacy of Bronchoalveolar Lavage as Adjunct Therapy in the Treatment of Neonatal Severe Pneumonia: A Prospective Case-Control Study.,"OBJECTIVE The aim of this study was to investigate the efficacy and safety of bronchoalveolar lavage (BAL) in the treatment of neonatal severe pneumonia (NSP). METHODS One hundred patients with severe pneumonia were randomly divided into two groups, the BAL and control groups, with 50 patients in each group. In the BAL group, normal saline was instilled into the endotracheal tube for BAL. Before and after lavage, lung ultrasound (LUS) monitoring was performed to observe the lung pathological changes. Conventional treatment was administered in the control group. The need for and duration of invasive mechanical ventilation, the complication rate, the duration and cost of hospitalization and the mortality rate were compared between the two groups. RESULTS The results of this study showed that there were 35 (70%) patients who meet the indications of the invasive mechanical ventilation (IMV) at admission in the BAL group, while there were only 15 (30%) patients still requiring IMV after BAL therapy. The duration of IMV was 41.7 ± 7.5 vs. 97.7 ± 12.9 h in BAL and controls, the incidence rate of complications was 8.0% vs. 20.0% in both groups, the length of hospital stay was 9.2 ± 1.9 vs. 14.1 ± 2.1 days in both groups, and the expense of hospital cost was 12 557 ± 832 vs. 19 121 ± 929 Chinese Yuan in both groups. All patients had stable vital signs during lavage, and no significant adverse side effects were observed. CONCLUSION BAL was significantly beneficial for NSP with no significant adverse side effects; LUS is a useful tool for the timely detection of BAL effects.",2020,BAL was significantly beneficial for NSP with no significant adverse side effects; LUS is a useful tool for the timely detection of BAL effects.,"['neonatal severe pneumonia (NSP', 'Neonatal Severe Pneumonia', 'One hundred patients with severe pneumonia']","['Bronchoalveolar Lavage', 'bronchoalveolar lavage (BAL']","['length of hospital stay', 'expense of hospital cost', 'stable vital signs', 'incidence rate of complications', 'adverse side effects', 'duration of IMV', 'invasive mechanical ventilation (IMV', 'complication rate, the duration and cost of hospitalization and the mortality rate']","[{'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1535502', 'cui_str': 'Lung Lavage'}, {'cui': 'C0012383', 'cui_str': 'Dimercaprol'}]","[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0206174', 'cui_str': 'Hospital Costs'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0518766'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}]",100.0,0.0200377,BAL was significantly beneficial for NSP with no significant adverse side effects; LUS is a useful tool for the timely detection of BAL effects.,"[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Neonatology and NICU, Beijing Chaoyang District Maternal and Child Healthcare Hospital, Beijing 100021, China.'}, {'ForeName': 'Hui-Rong', 'Initials': 'HR', 'LastName': 'Zhao', 'Affiliation': 'Department of Obstetrics and Gynecology, The West Division of Beijing Chaoyang Hospital, Capital University of Medical Science, Beijing 100043, China.'}, {'ForeName': 'Hua-Li', 'Initials': 'HL', 'LastName': 'Wei', 'Affiliation': 'Department of Obstetrics and Gynecology, Emergency General Hospital, Beijing 100028, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Obstetrics and Gynecology, The West Division of Beijing Chaoyang Hospital, Capital University of Medical Science, Beijing 100043, China.'}, {'ForeName': 'Ru-Xin', 'Initials': 'RX', 'LastName': 'Qiu', 'Affiliation': 'Department of Neonatology and NICU, Beijing Chaoyang District Maternal and Child Healthcare Hospital, Beijing 100021, China.'}, {'ForeName': 'Xiao-Ling', 'Initials': 'XL', 'LastName': 'Ren', 'Affiliation': 'Department of Neonatology and NICU, Beijing Chaoyang District Maternal and Child Healthcare Hospital, Beijing 100021, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Neonatology and NICU, Beijing Chaoyang District Maternal and Child Healthcare Hospital, Beijing 100021, China.'}, {'ForeName': 'Yue-Qiao', 'Initials': 'YQ', 'LastName': 'Gao', 'Affiliation': 'Department of Neonatology and NICU, Beijing Chaoyang District Maternal and Child Healthcare Hospital, Beijing 100021, China.'}]",Journal of tropical pediatrics,['10.1093/tropej/fmaa010'] 4220,31019996,Prolonged-release melatonin in patients with idiopathic REM sleep behavior disorder.,"Objective We investigated the effects of prolonged-release melatonin (PRM) on idiopathic rapid eye movement (REM) sleep behavior disorder (iRBD). Methods In this 4-week, randomized, double-blind, placebo-controlled pilot study, 30 participants with polysomnography-confirmed iRBD were assigned to receive PRM 2 mg per day, PRM 6 mg per day, or placebo. Medication was administered orally 30 min before bedtime. Primary outcomes included scores from the Clinical Global Impression-Improvement (CGI-I) and the Korean version of the RBD questionnaire-Hong Kong (RBDQ-KR). The secondary outcomes included RBDQ-KR factor 1 and factor 2 subscores, the Pittsburgh Sleep Quality Index score, the Epworth Sleepiness Scale score, the Short Form Health Survey version 2 score, and the frequency of dream-enacting behaviors assessed using a sleep diary. Results After 4 weeks, there were no differences in the proportions of patients with a CGI-I score of much improved or very much improved among the study groups. In addition, RBDQ-KR scores and secondary outcomes were not improved in all groups at 4 weeks, and there were no differences between the groups. Conclusion Our findings suggest that PRM may not be effective in treating RBD-related symptoms within the dose range used in this study. Further studies using doses higher than 6 mg per day are warranted.",2019,"After 4 weeks, there were no differences in the proportions of patients with a CGI-I score of much improved or very much improved among the study groups.","['patients with idiopathic REM sleep behavior disorder', '30 participants with polysomnography-confirmed iRBD']","['Prolonged-release melatonin', 'placebo', 'prolonged-release melatonin (PRM', 'PRM 2\xa0mg per day, PRM 6\xa0mg per day, or placebo', 'PRM']","['idiopathic rapid eye movement (REM) sleep behavior disorder (iRBD', 'scores from the Clinical Global Impression-Improvement (CGI-I) and the Korean version of the RBD questionnaire-Hong Kong (RBDQ-KR', 'RBDQ-KR scores and secondary outcomes', 'RBDQ-KR factor 1 and factor 2 subscores, the Pittsburgh Sleep Quality Index score, the Epworth Sleepiness Scale score, the Short Form Health Survey version 2 score, and the frequency of dream-enacting behaviors assessed using a sleep diary']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0751772', 'cui_str': 'REM Behavior Disorder'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}]","[{'cui': 'C4544856', 'cui_str': 'Prolonged-release (release characteristic)'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439505', 'cui_str': 'per day'}]","[{'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0751772', 'cui_str': 'REM Behavior Disorder'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4545801', 'cui_str': 'PSQI (Pittsburgh Sleep Quality Index) score'}, {'cui': 'C4706348', 'cui_str': 'Epworth Sleepiness Scale score (observable entity)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0013117', 'cui_str': 'Dreams'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}]",30.0,0.326204,"After 4 weeks, there were no differences in the proportions of patients with a CGI-I score of much improved or very much improved among the study groups.","[{'ForeName': 'Jin-Sun', 'Initials': 'JS', 'LastName': 'Jun', 'Affiliation': 'Department of Neurology Seoul National University Hospital Seoul Republic of Korea.'}, {'ForeName': 'Ryul', 'Initials': 'R', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology Seoul National University Hospital Seoul Republic of Korea.'}, {'ForeName': 'Jung-Ick', 'Initials': 'JI', 'LastName': 'Byun', 'Affiliation': 'Department of Neurology Kyung Hee University Hospital at Gangdong Seoul Republic of Korea.'}, {'ForeName': 'Tae-Joon', 'Initials': 'TJ', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology Ajou University School of Medicine Suwon Republic of Korea.'}, {'ForeName': 'Jung-Ah', 'Initials': 'JA', 'LastName': 'Lim', 'Affiliation': 'Department of Neurology Kangnam Sacred Heart Hospital Hallym University College of Medicine Seoul Republic of Korea.'}, {'ForeName': 'Jun-Sang', 'Initials': 'JS', 'LastName': 'Sunwoo', 'Affiliation': 'Department of Neurology Soonchunhyang University Seoul Hospital Seoul Republic of Korea.'}, {'ForeName': 'Soon-Tae', 'Initials': 'ST', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology Seoul National University Hospital Seoul Republic of Korea.'}, {'ForeName': 'Keun-Hwa', 'Initials': 'KH', 'LastName': 'Jung', 'Affiliation': 'Department of Neurology Seoul National University Hospital Seoul Republic of Korea.'}, {'ForeName': 'Kyung-Il', 'Initials': 'KI', 'LastName': 'Park', 'Affiliation': 'Department of Neurology Seoul National University Healthcare System Gangnam Center Seoul Republic of Korea.'}, {'ForeName': 'Kon', 'Initials': 'K', 'LastName': 'Chu', 'Affiliation': 'Department of Neurology Seoul National University Hospital Seoul Republic of Korea.'}, {'ForeName': 'Manho', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology Seoul National University Hospital Seoul Republic of Korea.'}, {'ForeName': 'Sang Kun', 'Initials': 'SK', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology Seoul National University Hospital Seoul Republic of Korea.'}, {'ForeName': 'Ki-Young', 'Initials': 'KY', 'LastName': 'Jung', 'Affiliation': 'Department of Neurology Seoul National University Hospital Seoul Republic of Korea.'}]",Annals of clinical and translational neurology,['10.1002/acn3.753'] 4221,32050214,Prospective Randomized Comparative Trial: Visual Performance Comparison Of Two Enhanced Depth Of Focus IOLs - Symfony and IC-8.,"PURPOSE To compare the visual acuity and satisfaction outcomes of two different concepts of enhanced depth of focus intraocular lenses (EDOF IOLs). SETTING University Eye Hospital Bochum, Germany DESIGN:: Prospective randomized comparative clinical trial METHODS:: This study included a sample of 76 eyes of 38 patients undergoing cataract surgery with the implantation of two different EDOF concepts. In the first group (IC-8 group) a monofocal 1-piece Tecnis Z B00 IOL (Johnson & Johnson Vision) was implanted in the dominant eye and an IC-8 IOL (AcuFocus) was implanted in the non-dominant eye. In the second group (Symfony group) a Tecnis Symfony IOL (Johnson & Johnson Vision) was implanted in both eyes. The target refraction of the dominat eye was emmetropia and slight myopia (mini-monovision; -0.75 D) in the non-dominant eye. Visual and refractive outcomes and patient satisfaction rates were evaluated 3 months after surgery. RESULTS In both groups no intra- or postoperative complications occurred. The target refraction was reached in both groups without statistical significant differences. The uncorrected distance visual acuity (UDVA, photopic and mesopic light conditions) was excellent in both groups with statistically significant better results in the IC-8 goup (logMAR; IC-8 group -0.1 ± 0.07, Symfony group 0.07 ± 0.1, p-value 0.02 (photopic); IC-8 group 0.12 ± 0.09, Symfony group 0.22 ± 0.1, p-value <0.01 (mesopic)). Binocular uncorrected intermediate visual acuity (UIVA) and uncorrected near visual acuity (UNVA) were also good in both groups without significant differences (UIVA IC-8 group 0.01 ± 0.07, Symfony group -0.01 ± 0.08, p-value 0.35; UNVA IC-8 group 0.14 ± 0.11, Symfony group 0.09 ± 0.08, p-value 0.14). Subjective satisfaction was high in both groups. CONCLUSION Both EDOF IOLs provided a very good UDVA with superior results in the IC-8 group, good UIVA and UNVA under photopic light conditions. Subjective patient satisfaction was higher in the IC-8 group.",2020,"The uncorrected distance visual acuity (UDVA, photopic and mesopic light conditions) was excellent in both groups with statistically significant better results in the IC-8 goup (logMAR; IC-8 group -0.1 ± 0.07, Symfony group 0.07 ± 0.1, p-value 0.02","['sample of 76 eyes of 38 patients undergoing cataract surgery with the implantation of two different EDOF concepts', 'University Eye Hospital Bochum, Germany DESIGN']","['enhanced depth of focus intraocular lenses (EDOF IOLs', 'Two Enhanced Depth Of Focus IOLs - Symfony and IC-8', 'Tecnis Symfony IOL (Johnson & Johnson Vision']","['target refraction', 'uncorrected distance visual acuity (UDVA, photopic and mesopic light conditions', 'visual acuity and satisfaction outcomes', 'postoperative complications', 'Visual and refractive outcomes and patient satisfaction rates', 'Binocular uncorrected intermediate visual acuity (UIVA) and uncorrected near visual acuity (UNVA', 'Subjective patient satisfaction', 'Subjective satisfaction']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0023319', 'cui_str': 'Lenses, Intraocular'}, {'cui': 'C0042789', 'cui_str': 'Vision'}]","[{'cui': 'C0430943', 'cui_str': 'Refraction'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C1690987', 'cui_str': 'Intermediate visual acuity'}, {'cui': 'C0429541', 'cui_str': 'Near visual acuity (observable entity)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}]",38.0,0.0530222,"The uncorrected distance visual acuity (UDVA, photopic and mesopic light conditions) was excellent in both groups with statistically significant better results in the IC-8 goup (logMAR; IC-8 group -0.1 ± 0.07, Symfony group 0.07 ± 0.1, p-value 0.02","[{'ForeName': 'Merita', 'Initials': 'M', 'LastName': 'Schojai', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'Tim Schultz', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'Corinna Jerke', 'Affiliation': ''}, {'ForeName': 'Dipl Ing', 'Initials': 'DI', 'LastName': 'Jörg Böcker', 'Affiliation': ''}, {'ForeName': 'H Burkhard', 'Initials': 'HB', 'LastName': 'Dick', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000068'] 4222,31995222,Comparative Effect of Mother's Hug and Massage on Neonatal Pain Behaviors Caused by Blood Sampling: A Randomized Clinical Trial.,"BACKGROUND The early experience of pain can lead to complications such as tachycardia, tachypnea and increased metabolic needs of the body, thereby exacerbation of the behavioral and physiological responses to pain in neonates. The current study aimed to compare the effect of a mother's hug and massage on pain behaviors during and after blood sampling in neonates. METHOD This study was a randomized clinical trial. A total of 135 healthy full-term neonates were selected by convenience sampling method. Samples were randomly assigned to a mother's hug group, massage group or control group. In all three groups, the behavioral responses of the neonate were measured and recorded before, immediately and 5 min after blood sampling by Neonatal Infant Pain Scale. Heart rate, respiratory rate and blood oxygen saturation were recorded with pulse oximetry, and the crying period was measured from start to silence using a stopwatch. RESULTS The results showed that after 5 min, the pain and heart rate in the mother's hug group decreased significantly compared to the massage and control groups (p < 0.001). There were no significant changes in the respiratory rate and blood oxygen saturation level in any of the newborns during blood sampling (p > 0.05). The duration of crying in the mother's hug group had more reduction than that of the massage and control groups (p < 0.001). CONCLUSION The placement of the baby in the mother's hug during painful procedures is recommended due to the reduction of pain, the improvement of physiological symptoms and the promotion of neonatal health.",2020,There were no significant changes in the respiratory rate and blood oxygen saturation level in any of the newborns during blood sampling (p > 0.05).,"['135 healthy full-term neonates', 'neonates']","[""mother's hug and massage"", 'Blood Sampling', ""Mother's Hug and Massage"", ""mother's hug group, massage group or control group""]","['Heart rate, respiratory rate and blood oxygen saturation', 'duration of crying', 'pain behaviors', 'pain and heart rate', 'respiratory rate and blood oxygen saturation level', 'behavioral responses of the neonate', 'Neonatal Pain Behaviors']","[{'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0005834', 'cui_str': 'Blood Specimen Collection'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen (observable entity)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}]",135.0,0.0406076,There were no significant changes in the respiratory rate and blood oxygen saturation level in any of the newborns during blood sampling (p > 0.05).,"[{'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Roshanray', 'Affiliation': 'Neonatal Intensive Care Nursing, Pediatric Hospital, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Rayyani', 'Affiliation': 'Nursing Research Center, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Mahlagha', 'Initials': 'M', 'LastName': 'Dehghan', 'Affiliation': 'Critical Care Department, Nursing School, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Aref', 'Initials': 'A', 'LastName': 'Faghih', 'Affiliation': 'Social Determination in Health Promotion Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}]",Journal of tropical pediatrics,['10.1093/tropej/fmaa001'] 4223,32150232,Efficacy of Gabapentin for the Treatment of Alcohol Use Disorder in Patients With Alcohol Withdrawal Symptoms: A Randomized Clinical Trial.,"Importance Although an estimated 30 million people meet criteria for alcohol use disorder (AUD), few receive appropriate pharmacotherapy. A more personalized, symptom-specific, approach might improve efficacy and acceptance. Objective To examine whether gabapentin would be useful in the treatment of AUD, especially in those with the most alcohol withdrawal symptoms. Design, Setting, and Participants This double-blind randomized clinical trial conducted between November 2014 and June 2018 evaluated gabapentin vs placebo in community-recruited participants screened and treated in an academic outpatient setting over a 16-week treatment period. A total of 145 treatment-seeking individuals who met Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) criteria for AUD and were not receiving other AUD intervention were screened, and 96 who also met recent alcohol withdrawal criteria were randomized to treatment after 3 abstinent days. Daily drinking was recorded, and percentage of disialo carbohydrate-deficient transferrin in the blood, a heavy drinking marker, was collected at baseline and monthly during treatment. Interventions Gabapentin up to 1200 mg/d, orally, vs placebo along with 9 medical management visits (20 minutes each). Main Outcomes and Measures The percentage of individuals with no heavy drinking days and those with total abstinence were compared between treatment groups and further evaluated based on prestudy alcohol withdrawal symptoms. Results Of 96 randomized individuals, 90 were evaluable (44 in the gabapentin arm and 46 in the placebo arm), with a mean (SD) age of 49.6 (10.1) years; 69 were men (77%) and 85 were white (94%). The evaluable participants had 83% baseline heavy drinking days (4 or more drinks/day for women, 5 or more for men) and met 4.5 alcohol withdrawal criteria from the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition). More gabapentin-treated individuals had no heavy drinking days (12 of 44 participants [27%]) compared with placebo (4 of 46 participants [9%]), a difference of 18.6% (95% CI, 3.1-34.1; P = .02; number needed to treat [NNT], 5.4), and more total abstinence (8 of 44 [18%]) compared with placebo (2 of 46 [4%]), a difference of 13.8% (95% CI, 1.0-26.7; P = .04; NNT, 6.2). The prestudy high-alcohol withdrawal group had positive gabapentin effects on no heavy drinking days (P < .02; NNT, 3.1) and total abstinence (P = .003; NNT, 2.7) compared with placebo, while within the low-alcohol withdrawal group, there were no significant differences. These findings were similar for other drinking variables, where gabapentin was more efficacious than placebo in the high-alcohol withdrawal group only. Gabapentin caused more dizziness, but this did not affect efficacy. Conclusions and Relevance These data, combined with others, suggest gabapentin might be most efficacious in people with AUD and a history of alcohol withdrawal symptoms. Future studies should evaluate sleep changes and mood during early recovery as mediators of gabapentin efficacy. Trial Registration ClinicalTrials.gov Identifier: NCT02349477.",2020,"These findings were similar for other drinking variables, where gabapentin was more efficacious than placebo in the high-alcohol withdrawal group only.","['in community-recruited participants screened and treated in an academic outpatient setting over a 16-week treatment period', '145 treatment-seeking individuals who met Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) criteria for AUD and were not receiving other AUD intervention were screened, and 96 who also met recent alcohol withdrawal criteria', 'Patients With Alcohol Withdrawal Symptoms', 'arm and 46 in the placebo arm), with a mean (SD) age of 49.6 (10.1) years; 69 were men (77%) and 85 were white (94', 'evaluable participants had 83% baseline heavy drinking days (4 or more drinks/day for women, 5 or more for men) and met 4.5 alcohol withdrawal criteria from the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition', 'people with AUD and a history of alcohol withdrawal symptoms', '96 randomized individuals']","['gabapentin', 'Gabapentin', 'placebo', 'gabapentin vs placebo']","['percentage of individuals with no heavy drinking days and those with total abstinence', 'heavy drinking days', 'dizziness', 'total abstinence', 'prestudy alcohol withdrawal symptoms']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal Symptoms'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal Symptoms'}]",,0.35725,"These findings were similar for other drinking variables, where gabapentin was more efficacious than placebo in the high-alcohol withdrawal group only.","[{'ForeName': 'Raymond F', 'Initials': 'RF', 'LastName': 'Anton', 'Affiliation': 'Addiction Sciences Division, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Latham', 'Affiliation': 'Addiction Sciences Division, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Voronin', 'Affiliation': 'Addiction Sciences Division, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Book', 'Affiliation': 'Addiction Sciences Division, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Hoffman', 'Affiliation': 'Addiction Sciences Division, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Prisciandaro', 'Affiliation': 'Addiction Sciences Division, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Bristol', 'Affiliation': 'Addiction Sciences Division, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.0249'] 4224,32154928,"NRG/RTOG 1122: A phase 2, double-blinded, placebo-controlled study of bevacizumab with and without trebananib in patients with recurrent glioblastoma or gliosarcoma.","BACKGROUND Targeting vascular endothelial growth factor (VEGF) alone does not improve overall survival (OS) in recurrent glioblastoma (rGBM). The angiopoiein (Ang)-TIE2 system may play a role in tumor survival under VEGF inhibition. We conducted a phase 2, double-blinded, placebo-controlled trial of bevacizumab plus trebananib (a novel Fc fusion protein that sequesters Ang1/Ang2) over bevacizumab alone in rGBM. METHODS Patients ≥18 years of age with a Karnofsky performance status ≥70 and GBM or variants in first or second relapse were randomized to bevacizumab 10 mg/kg every 2 weeks plus trebananib 15 mg/kg every week or bevacizumab plus placebo. The primary endpoint was 6-month progression-free survival (PFS). RESULTS After an initial 6-patient lead-in cohort confirmed the safety of combining bevacizumab and trebananib, 115 eligible patients were randomized to the control (n = 58) or experimental treatment (n = 57). In the control arm, 6-month PFS was 41.1%, median survival time was 11.5 months (95% CI, 8.4-14.2 months), median PFS was 4.8 months (95% CI, 3.8-7.1 months), and radiographic response (RR) was 5.9%. In the experimental arm, 6-month PFS was 22.6%, median survival time was 7.5 months (95% CI, 6.8-10.1 months), median PFS was 4.2 months (95% CI, 3.7-5.6 months), and RR was 4.2%. The rate of severe toxicities was not significantly different between arms. CONCLUSION The combination of bevacizumab and trebananib was well tolerated but did not significantly improve 6-month PFS rate, PFS, or OS for patients with rGBM over bevacizumab alone. The shorter PFS in the experimental arm with a hazard ratio of 1.51 (P = .04) suggests that the addition of trebananib to bevacizumab is detrimental.",2020,"The combination of bevacizumab and trebananib was well tolerated but did not significantly improve 6-month PFS rate, PFS, or OS for patients with rGBM over bevacizumab alone.","['patients with recurrent glioblastoma or gliosarcoma', '115 eligible patients', 'Patients ≥18\xa0years of age with a Karnofsky performance status ≥70 and GBM or variants in first or second relapse']","['bevacizumab plus trebananib', 'bevacizumab 10\xa0mg/kg every 2\xa0weeks plus trebananib 15\xa0mg/kg every week or bevacizumab plus placebo', 'placebo', 'bevacizumab with and without trebananib', 'bevacizumab', 'bevacizumab and trebananib', 'angiopoiein']","['radiographic response (RR', '6-month PFS rate, PFS, or OS', 'overall survival (OS', 'rate of severe toxicities', 'shorter PFS', 'median survival time', '6-month progression-free survival (PFS', '6-month PFS', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}, {'cui': 'C0206726', 'cui_str': 'Sarcomatous Glioma'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky Scale'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3660912', 'cui_str': 'trenananib'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",115.0,0.680496,"The combination of bevacizumab and trebananib was well tolerated but did not significantly improve 6-month PFS rate, PFS, or OS for patients with rGBM over bevacizumab alone.","[{'ForeName': 'Eudocia Q', 'Initials': 'EQ', 'LastName': 'Lee', 'Affiliation': ""Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts.""}, {'ForeName': 'Peixin', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, American College of Radiology, Philadelphia, Pennsylvania.'}, {'ForeName': 'Patrick Y', 'Initials': 'PY', 'LastName': 'Wen', 'Affiliation': ""Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts.""}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Gerstner', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Reardon', 'Affiliation': ""Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts.""}, {'ForeName': 'Kenneth D', 'Initials': 'KD', 'LastName': 'Aldape', 'Affiliation': 'Toronto General Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'deGroot', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Pan', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Raizer', 'Affiliation': 'Northwestern University, Evanston, Illinois.'}, {'ForeName': 'Lyndon J', 'Initials': 'LJ', 'LastName': 'Kim', 'Affiliation': 'Thomas Jefferson University Hospital, Philadelphia, Pennsylvania.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Chmura', 'Affiliation': 'University of Chicago Comprehensive Cancer Center, Chicago, Illinois.'}, {'ForeName': 'H Ian', 'Initials': 'HI', 'LastName': 'Robins', 'Affiliation': 'University of Wisconsin Hospital and Clinics, Madison, Wisconsin.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Connelly', 'Affiliation': 'Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Battiste', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Villano', 'Affiliation': 'University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Wagle', 'Affiliation': 'University of Southern California, Los Angeles, California.'}, {'ForeName': 'Ryan T', 'Initials': 'RT', 'LastName': 'Merrell', 'Affiliation': 'North Shore University Health System, Evanston, Illinois.'}, {'ForeName': 'Merideth M', 'Initials': 'MM', 'LastName': 'Wendland', 'Affiliation': 'The US Oncology Network-Willamette Valley Cancer Institute, Eugene, Oregon.'}, {'ForeName': 'Minesh P', 'Initials': 'MP', 'LastName': 'Mehta', 'Affiliation': 'Baptist Hospital of Miami, Miami, Florida.'}]",Cancer,['10.1002/cncr.32811'] 4225,32150017,Can Benign Paroxysmal Positional Vertigo Be Treated in a One Session?,"OBJECTIVE To determine the reliability and safety of posterior canal BPPV (pc-BPPV) treatment with subsequent assessment of the effectiveness of the maneuver in a single session, compared to the classic weekly procedure. METHOD A prospective study of two randomized groups of unilateral pc-BPPV was performed: a weekly management group (27 patients) and single-session treatment group (26 patients). The number of maneuvers required to clear pc-BPPV, incidence of side effects (re-entries and canal conversions), and recurrence rates were compared. RESULTS There were no statistically significant differences in the number of maneuvers needed to resolve pc-BPPV, the incidence of side effects, or the recurrence rate between the two groups. Two re-entries were diagnosed in the single-session group, and both were easily and successfully treated. Three early recurrences were found in the single-session group and one spontaneous recovery was encountered in the weekly group. Time required to discharge patients to follow-up was significantly reduced in the single-session group. CONCLUSION Managing pc-BPPV in one session is safe and reliable, resulting in fewer visits to outpatient clinics and optimization of treatment strategies.",2020,"There were no statistically significant differences in the number of maneuvers needed to resolve pc-BPPV, the incidence of side effects, or the recurrence rate between the two groups.",[],"['unilateral pc-BPPV', 'posterior canal BPPV (pc-BPPV']","['number of maneuvers needed to resolve pc-BPPV, the incidence of side effects, or the recurrence rate', 'number of maneuvers required to clear pc-BPPV, incidence of side effects (re-entries and canal conversions), and recurrence rates', 'Time required to discharge patients to follow-up', 'spontaneous recovery']",[],"[{'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0155502', 'cui_str': 'Vertigo, Benign Recurrent'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0442636', 'cui_str': 'Canal (environment)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C3714811', 'cui_str': 'Resolved (qualifier value)'}, {'cui': 'C0155502', 'cui_str': 'Vertigo, Benign Recurrent'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C0442636', 'cui_str': 'Canal (environment)'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}]",,0.0413024,"There were no statistically significant differences in the number of maneuvers needed to resolve pc-BPPV, the incidence of side effects, or the recurrence rate between the two groups.","[{'ForeName': 'Vanesa', 'Initials': 'V', 'LastName': 'Pérez-Guillén', 'Affiliation': 'Otoneurology Section, ENT Department, Hospital Universitario La Fe, Valencia.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Franco-Gutiérrez', 'Affiliation': 'Otoneurology Section, ENT Department, Hospital Universitario Marqués de Valdecilla, Santander.'}, {'ForeName': 'Maria Teresa Gil-', 'Initials': 'MTG', 'LastName': 'Aguilar', 'Affiliation': 'Otoneurology Section, ENT Department, Hospital Universitario Marqués de Valdecilla, Santander.'}, {'ForeName': 'Enrique García-', 'Initials': 'EG', 'LastName': 'Zamora', 'Affiliation': 'Otoneurology Section, ENT Department, Hospital Universitario La Fe, Valencia.'}, {'ForeName': 'Paz', 'Initials': 'P', 'LastName': 'Pérez-Vázquez', 'Affiliation': 'ENT Department, Hospital Universitario de Cabueñes, Gijón, Spain.'}]","Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology",['10.1097/MAO.0000000000002621'] 4226,31691827,Long-term study of the safety and maintenance of efficacy of solriamfetol (JZP-110) in the treatment of excessive sleepiness in participants with narcolepsy or obstructive sleep apnea.,"STUDY OBJECTIVES To evaluate long-term safety and maintenance of efficacy of solriamfetol treatment for excessive daytime sleepiness in narcolepsy and obstructive sleep apnea (OSA). METHODS Participants with narcolepsy or OSA who completed a prior solriamfetol study were eligible. A 2-week titration period was followed by a maintenance phase (up to 50 weeks). Efficacy was assessed by Epworth Sleepiness Scale (ESS) and Patient and Clinical Global Impression of Change (PGI-C and CGI-C, respectively). After approximately 6 months of treatment, a subgroup entered a 2-week placebo-controlled randomized withdrawal (RW) phase. Change in ESS from beginning to end of the RW phase was the primary endpoint; PGI-C and CGI-C were secondary endpoints. Safety was assessed throughout the study. RESULTS In the maintenance phase, solriamfetol-treated participants demonstrated clinically meaningful improvements on ESS, PGI-C, and CGI-C. In the RW phase, least squares mean change on ESS was 1.6 in participants continuing solriamfetol versus 5.3 in participants switched to placebo (p < .0001). For both secondary endpoints, higher percentages of participants receiving placebo were reported as worse at the end of the RW phase versus solriamfetol (p < .0001). Common treatment-emergent adverse events (TEAEs) with solriamfetol were headache, nausea, nasopharyngitis, insomnia, dry mouth, anxiety, decreased appetite, and upper respiratory tract infection; 27 (4.2%) participants experienced at least one serious TEAE, and 61 (9.5%) withdrew because of TEAEs. CONCLUSIONS This study demonstrated long-term maintenance of efficacy of solriamfetol under open-label and double-blind, placebo-controlled conditions. Safety profile of solriamfetol was consistent with previous 12-week studies; no new safety concerns were identified. TRIAL REGISTRATION NCT02348632.",2020,"Safety profile of solriamfetol was consistent with previous 12-week studies; no new safety concerns were identified. ","['excessive daytime sleepiness in narcolepsy and obstructive sleep apnea (OSA', 'Participants with narcolepsy or OSA who completed a prior solriamfetol study were eligible', 'participants with narcolepsy or obstructive sleep apnea']","['placebo', 'solriamfetol under open-label and double-blind, placebo', 'solriamfetol (JZP-110', 'solriamfetol treatment']","['ESS', 'Safety', 'excessive sleepiness', 'Epworth Sleepiness Scale (ESS) and Patient and Clinical Global Impression of Change (PGI-C and CGI-C, respectively', 'Efficacy', 'ESS, PGI-C, and CGI-C', 'headache, nausea, nasopharyngitis, insomnia, dry mouth, anxiety, decreased appetite, and upper respiratory tract infection']","[{'cui': 'C4551761', 'cui_str': 'Excessive daytime sleepiness'}, {'cui': 'C0027404', 'cui_str': 'Narcoleptic Syndrome'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C4547387', 'cui_str': 'JZP-110'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0917799', 'cui_str': 'Hypersomnia'}, {'cui': 'C3541276', 'cui_str': 'ESS - Epworth Sleepiness Scale'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite (finding)'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}]",,0.151496,"Safety profile of solriamfetol was consistent with previous 12-week studies; no new safety concerns were identified. ","[{'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Malhotra', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego, La Jolla.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Shapiro', 'Affiliation': 'University of Toronto, ON, Canada.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Pepin', 'Affiliation': 'HP2 Laboratory, INSERM U1042, University Grenoble Alpes, France.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hedner', 'Affiliation': 'Sahlgrenska University Hospital, Gothenburg University, Sweden.'}, {'ForeName': 'Mansoor', 'Initials': 'M', 'LastName': 'Ahmed', 'Affiliation': 'Cleveland Sleep Research Center, OH.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Foldvary-Schaefer', 'Affiliation': 'Cleveland Clinic Lerner College of Medicine, OH.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Strollo', 'Affiliation': 'University of Pittsburgh/Veterans Administration Pittsburgh Health System, PA.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Mayer', 'Affiliation': 'Hephata Klinik, Schwalmstadt, Germany.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Sarmiento', 'Affiliation': 'San Francisco Veterans Administration Healthcare System, CA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Baladi', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, CA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Chandler', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, CA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Lee', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, CA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Schwab', 'Affiliation': 'University of Pennsylvania, Philadelphia.'}]",Sleep,['10.1093/sleep/zsz220'] 4227,32081221,Avoiding Bladder Catheters During Atrial Fibrillation Ablation.,"OBJECTIVES This study sought to determine if atrial fibrillation (AF) ablation can be performed safely without bladder catheterization. BACKGROUND Patients undergoing AF ablation often receive bladder catheters. Catheterization is associated with potential complications. The ABCD-AF (Avoiding Bladder Catheters During Atrial Fibrillation) ablation study evaluates the advantages of performing AF ablation without routine catheterization. METHODS In this single-center, prospective, randomized controlled trial, 80 patients received bladder catheterization (group A), and 80 patients received only as-needed catheterization (group B). The primary endpoint was a composite of cystitis, urethral injury, hematuria, dysuria, or urinary retention. RESULTS The mean patient age was 63 ± 13 years, and 33% of patients were female. The primary outcome was reached in 45 patients in group A and 11 patients in group B (p < 0.001). Urinary tract infection occurred in 7 patients in group A and 2 patients in group B (p = 0.17). Urinary retention occurred in 12 patients in group A and 5 patients in group B (p = 0.07). Randomization to catheterization carried an odds ratio of 8.1 (95% confidence interval [CI]: 3.7 to 17.5; p < 0.001), and male sex carried an odds ratio of 3.8 (95% CI: 1.7 to 8.6; p = 0.001) for the primary endpoint. On subgroup analysis, randomization to undergo catheterization had no association with the primary outcome in female patients but had an odds ratio of 14.6 (95% CI: 5.6 to 38.1; p < 0.001) in male patients. In multivariable analysis, sex and catheter status remained independently associated with the primary outcome. CONCLUSIONS Bladder catheterization can be safely avoided in patients undergoing AF ablation and is associated with a significant reduction in adverse outcomes, especially in men.",2020,Urinary tract infection occurred in 7 patients in group A and 2 patients in group B (p = 0.17).,"['80 patients received', 'Patients undergoing AF ablation often receive bladder catheters', 'patients undergoing AF ablation', 'The mean patient age was 63 ± 13 years, and 33% of patients were female']","['Bladder Catheters', 'atrial fibrillation (AF) ablation', 'bladder catheterization', 'AF ablation without routine catheterization', 'Bladder catheterization']","['composite of cystitis, urethral injury, hematuria, dysuria, or urinary retention', 'Urinary tract infection', 'Urinary retention']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0179802', 'cui_str': 'Urinary catheter, device (physical object)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0179802', 'cui_str': 'Urinary catheter, device (physical object)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C1970989', 'cui_str': 'Insertion of catheter into urinary bladder'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0403701', 'cui_str': 'Injury of urethra (disorder)'}, {'cui': 'C0018965', 'cui_str': 'Hematuria'}, {'cui': 'C0013428', 'cui_str': 'Dysuria'}, {'cui': 'C0080274', 'cui_str': 'Urinary Retention'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}]",80.0,0.162444,Urinary tract infection occurred in 7 patients in group A and 2 patients in group B (p = 0.17).,"[{'ForeName': 'Asim S', 'Initials': 'AS', 'LastName': 'Ahmed', 'Affiliation': 'St. Vincent Medical Group, St. Vincent Hospital, Indianapolis, Indiana, USA.'}, {'ForeName': 'Brad A', 'Initials': 'BA', 'LastName': 'Clark', 'Affiliation': 'St. Vincent Medical Group, St. Vincent Hospital, Indianapolis, Indiana, USA.'}, {'ForeName': 'Sandeep A', 'Initials': 'SA', 'LastName': 'Joshi', 'Affiliation': 'St. Vincent Medical Group, St. Vincent Hospital, Indianapolis, Indiana, USA.'}, {'ForeName': 'Girish V', 'Initials': 'GV', 'LastName': 'Nair', 'Affiliation': 'St. Vincent Medical Group, St. Vincent Hospital, Indianapolis, Indiana, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Olson', 'Affiliation': 'St. Vincent Medical Group, St. Vincent Hospital, Indianapolis, Indiana, USA.'}, {'ForeName': 'Benzy J', 'Initials': 'BJ', 'LastName': 'Padanilam', 'Affiliation': 'St. Vincent Medical Group, St. Vincent Hospital, Indianapolis, Indiana, USA.'}, {'ForeName': 'Parin J', 'Initials': 'PJ', 'LastName': 'Patel', 'Affiliation': 'St. Vincent Medical Group, St. Vincent Hospital, Indianapolis, Indiana, USA. Electronic address: parin.patel@ascension.org.'}]",JACC. Clinical electrophysiology,['10.1016/j.jacep.2019.10.003'] 4228,31608389,Comparing internet-delivered cognitive therapy and behavior therapy with telephone support for insomnia disorder: a randomized controlled trial.,"STUDY OBJECTIVES Our aim was to compare the effects of Internet-delivered cognitive therapy (CT) and behavior therapy (BT) against a waitlist (WL) condition to better understand their unique contribution in the treatment of insomnia. METHODS Two hundred and nineteen participants with insomnia disorder were randomized to CT (n = 72), BT (n = 73), or WL (n = 74). The treatment arms consisted of 10 weekly internet-delivered modules with 15 min of telephone support per week. At pre, post, and follow-up, participants completed measures of insomnia severity, sleep diaries, functional impairment, anxiety, depression, quality of life, adverse events, satisfaction and perception of content, workload, and activity in treatment. Measures of completed exercises, modules, therapist support, and platform logins were also measured at posttreatment. RESULTS Moderate to large effect sizes for both CT and BT outperformed the WL on the majority of outcomes, with significant differences in favor of both therapy groups. Both treatment groups had significantly larger proportion of treatment remitters (CT: 35.8%, BT: 40%, WL: 2.7%) and responders (CT: 74.6%, BT 58.6%, WL: 10.8%) compared to the WL at posttreatment. There were no significant differences between the two therapy groups in terms of outcomes, except for sleep onset latency in favor of BT (6 min difference at posttreatment) and adverse events in favor of CT (CT 14.1% vs BT 43.2%). CONCLUSIONS This study indicates that both Internet-delivered CT and BT are effective as stand-alone therapies for insomnia disorder. Results highlight the need for examining which therapy and subcomponents that are necessary for change. CLINICALTRIALS.GOV IDENTIFIER NCT02984670.",2020,"Moderate to large effect sizes for both CT and BT outperformed the WL on the majority of outcomes, with significant differences in favor of both therapy groups.","['Two hundred and nineteen participants with insomnia disorder', 'insomnia disorder']","['CT', 'internet-delivered Cognitive Therapy and Behavior Therapy with telephone support', 'internet-delivered Cognitive Therapy (CT) and Behavior Therapy (BT', 'BT']","['insomnia severity, sleep diaries, functional impairment, anxiety, depression, quality of life, adverse events, satisfaction and perception of content, workload, and activity in treatment', 'adverse events', 'completed exercises, modules, therapist support, and platform logins', 'larger proportion of treatment remitters', 'sleep onset latency in favor of BT']","[{'cui': 'C4517648', 'cui_str': '219 (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0034380'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}]",219.0,0.0689668,"Moderate to large effect sizes for both CT and BT outperformed the WL on the majority of outcomes, with significant differences in favor of both therapy groups.","[{'ForeName': 'Rikard', 'Initials': 'R', 'LastName': 'Sunnhed', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Hesser', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Andersson', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Carlbring', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Morin', 'Affiliation': 'School of Psychology, Université Laval, Québec, Canada.'}, {'ForeName': 'Allison G', 'Initials': 'AG', 'LastName': 'Harvey', 'Affiliation': 'Department of Psychology, University of California, Berkeley, USA.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Jansson-Fröjmark', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden.'}]",Sleep,['10.1093/sleep/zsz245'] 4229,31806099,Effect of Metformin on Microvascular Endothelial Function in Polycystic Ovary Syndrome.,"OBJECTIVE To investigate the factors that are associated with the effect of metformin on endothelial dysfunction in polycystic ovary syndrome (PCOS). PATIENTS AND METHODS From March 24, 2014, to November 18, 2016, 48 women with PCOS were randomly assigned to 1500 mg/d of metformin (N=29) or no treatment (N=13) for 3 months; 42 patients (29 in the initial treatment group and 13 in the no treatment group) completed the study. Study variables were measured at baseline and after 3 months. Participants who did not receive metformin initially were then treated with metformin for another 3 months, and study variables were measured again. Endothelial function was measured as reactive hyperemia-peripheral arterial tonometry (RH-PAT) from the index finger. RESULTS The age and baseline endothelial function (mean ± SD) of the participants were 32.7±6.9 years and 1.8±0.5, respectively. No notable change was observed in endothelial function after 3 months with metformin compared with no treatment. However, after stratifying participants who received metformin based on baseline endothelial function, there was a significant improvement following metformin treatment in participants with abnormal baseline endothelial function (1.3±0.3 vs 1.7±0.3; P<.001) but not in those with normal baseline endothelial function (2.1±0.4 vs 2.0±0.5; P=.11). CONCLUSION Metformin improves endothelial function in women with PCOS and endothelial dysfunction independent of changes in glucose metabolism, dyslipidemia, or presence of prediabetes. Metformin has a direct effect on endothelial function in PCOS, and measurement of endothelial function can stratify and follow response to metformin treatment in PCOS. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT02086526.",2019,"Metformin improves endothelial function in women with PCOS and endothelial dysfunction independent of changes in glucose metabolism, dyslipidemia, or presence of prediabetes.","['From March 24, 2014, to November 18, 2016, 48 women with PCOS', 'women with PCOS and endothelial dysfunction', 'Participants who did not receive', 'polycystic ovary syndrome (PCOS', 'Polycystic Ovary\xa0Syndrome']","['metformin', 'Metformin']","['glucose metabolism, dyslipidemia, or presence of prediabetes', 'abnormal baseline endothelial function', 'endothelial function', 'reactive hyperemia-peripheral arterial tonometry (RH-PAT', 'Microvascular Endothelial Function', 'Endothelial function']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0040420', 'cui_str': 'Tonometry'}, {'cui': 'C0030587', 'cui_str': 'Paroxysmal atrial tachycardia (disorder)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}]",48.0,0.0745244,"Metformin improves endothelial function in women with PCOS and endothelial dysfunction independent of changes in glucose metabolism, dyslipidemia, or presence of prediabetes.","[{'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Heidari', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Lerman', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Antigoni Z', 'Initials': 'AZ', 'LastName': 'Lalia', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Lilach O', 'Initials': 'LO', 'LastName': 'Lerman', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Alice Y', 'Initials': 'AY', 'LastName': 'Chang', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Mayo Clinic, Rochester, MN. Electronic address: Chang.Alice1@mayo.edu.'}]",Mayo Clinic proceedings,['10.1016/j.mayocp.2019.06.015'] 4230,31768867,"Single-Anastomosis Sleeve Jejunal Bypass, a Novel Bariatric Surgery, Versus Other Familiar Methods: Results of a 6-Month Follow-up-a Comparative Study.","BACKGROUND Obesity and its associated morbidities have become a significant concern all over the world. Bariatric surgery, regardless of its type, is the most effective approach for treating morbid obesity. Single-anastomosis sleeve jejunal (SASJ) bypass is a novel bariatric surgery technique and can be considered for patients with former background of severe gastroesophageal symptoms. The purpose of this research was to compare SASJ bypass outcomes with other techniques during a 6-month follow-up. METHODS This is a non-randomized clinical trial conducted on 100 patients, who underwent four types of bariatric surgery (classic Roux-en-Y bypass, SASJ bypass, omega gastric bypass, and sleeve gastrectomy), and each one of these types contained 25 cases, during the time period of 2 years from 2016 to 2018. Patients' information including age, gender, height, basal weight, body mass index (BMI), serum albumin, and hemoglobin A1C were recorded, within 1, 3, and 6 months after their surgery, and also were compared with each other. RESULTS Members of the four groups were similar due to their age, gender distribution, height, baseline BMI, hemoglobin A1C, albumin, and also excess weight (P value > 0.05); however, the sleeve gastrectomy group baseline weight was significantly higher compared with the other three groups (P value = 0.013). All of the groups significantly lost weight during this 6-month period, but the comparison between them indicated no statistical difference regarding excess weight loss, BMI, hemoglobin A1C, and albumin (P value > 0.05). The excess weight loss mean during 6 months in SASJ bypass was 34.2 ± 5.4%, which was comparable with other groups. CONCLUSIONS The weight loss trend after the SASJ bypass was similar to that of older techniques; consequently this technique can be considered for cases with particular indications due to the reversibility and also more accessible gastric follow-up studies in the SASJ approach. Further researches with longer follow-ups are strongly recommended.",2020,"All of the groups significantly lost weight during this 6-month period, but the comparison between them indicated no statistical difference regarding excess weight loss, BMI, hemoglobin A1C, and albumin (P value > 0.05).","['100 patients, who underwent four types of bariatric surgery (classic Roux-en-Y bypass, SASJ bypass, omega gastric bypass, and sleeve gastrectomy), and each one of these types contained 25 cases, during the time period of 2 years from 2016 to 2018', 'patients with former background of severe gastroesophageal symptoms']","['Single-anastomosis sleeve jejunal (SASJ) bypass', 'Single-Anastomosis Sleeve Jejunal Bypass']","['basal weight, body mass index (BMI), serum albumin, and hemoglobin A1C', 'excess weight loss mean', 'lost weight', 'excess weight loss, BMI, hemoglobin A1C, and albumin', 'weight loss', 'sleeve gastrectomy group baseline weight']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0439658', 'cui_str': 'Classic (qualifier value)'}, {'cui': 'C0002804', 'cui_str': 'Roux-en-Y Anastomosis'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1948053', 'cui_str': 'Time periods (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0183336', 'cui_str': 'Sleeve'}, {'cui': 'C0022378', 'cui_str': 'Jejunum'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}]","[{'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum (procedure)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1303013', 'cui_str': 'Baseline weight'}]",,0.016014,"All of the groups significantly lost weight during this 6-month period, but the comparison between them indicated no statistical difference regarding excess weight loss, BMI, hemoglobin A1C, and albumin (P value > 0.05).","[{'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Sayadishahraki', 'Affiliation': 'Isfahan University of Medical Sciences, Isfahan, 8174675731, Iran.'}, {'ForeName': 'Mohammad Taghi', 'Initials': 'MT', 'LastName': 'Rezaei', 'Affiliation': 'Isfahan University of Medical Sciences, Isfahan, 8174675731, Iran. Rezaei.mohammadtaghi@gmail.com.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Mahmoudieh', 'Affiliation': 'Isfahan University of Medical Sciences, Isfahan, 8174675731, Iran.'}, {'ForeName': 'Behrouz', 'Initials': 'B', 'LastName': 'Keleydari', 'Affiliation': 'Isfahan University of Medical Sciences, Isfahan, 8174675731, Iran.'}, {'ForeName': 'Shahab', 'Initials': 'S', 'LastName': 'Shahabi', 'Affiliation': 'Isfahan University of Medical Sciences, Isfahan, 8174675731, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Allami', 'Affiliation': 'Isfahan University of Medical Sciences, Isfahan, 8174675731, Iran.'}]",Obesity surgery,['10.1007/s11695-019-04266-9'] 4231,32179568,"Treatment of severe acute malnutrition with oat or standard ready-to-use therapeutic food: a triple-blind, randomised controlled clinical trial.","OBJECTIVE We hypothesised that an alternative RUTF (ready-to-use therapeutic food) made with oats (oat-RUTF) would be non-inferior to standard RUTF (s-RUTF). DESIGN This was a randomised, triple-blind, controlled, clinical non-inferiority trial comparing oat-RUTF to s-RUTF in rural Sierra Leone. Children aged 6-59 months with severe acute malnutrition (SAM) were randomised to oat-RUTF or s-RUTF. s-RUTF was composed of milk powder, sugar, peanut paste and vegetable oil, with a hydrogenated vegetable oil additive. Oat-RUTF contained oats and no hydrogenated vegetable oil additives. The primary outcome was graduation, an increase in anthropometric measurements such that the child was not acutely malnourished. Secondary outcomes were rates of growth, time to graduation and presence of adverse events. Intention to treat analyses was used. RESULTS Of the 1406 children were enrolled, graduation was attained in 404/721 (56%) children receiving oat-RUTF and 311/685 (45%) receiving s-RUTF (difference 10.6%, 95% CI 5.4% to 15.8%). Death, hospitalisation or remaining with SAM was seen in 87/721 (12%) receiving oat-RUTF and in 125/685 (18%) receiving s-RUTF (difference 6.2%, 95% CI 2.3 to 10.0, p=0.001). Time to graduation was less for children receiving oat RUTF; 3.9±1.8 versus 4.5±1.8 visits, respectively (p<0.001). Rates of weight in the oat-RUTF group were greater than in the s-RUTF group; 3.4±2.7 versus 2.5±2.3 g/kg/d, p<0.001. CONCLUSION Oat-RUTF is superior to s-RUTF in the treatment of SAM in Sierra Leone. We speculate that might be because of beneficial bioactive components or the absence of hydrogenated vegetable oil in oat-RUTF. TRIAL REGISTRATION NUMBER NCT03407326.",2020,"Rates of weight in the oat-RUTF group were greater than in the s-RUTF group; 3.4±2.7 versus 2.5±2.3 g/kg/d, p<0.001. CONCLUSION ","['Children aged 6-59 months with severe acute malnutrition (SAM', 'rural Sierra Leone', '1406 children were enrolled, graduation was attained in 404/721 (56']","['oat-RUTF to s-RUTF', 'oat-RUTF or s-RUTF', 'Oat-RUTF', 'milk powder, sugar, peanut paste and vegetable oil, with a hydrogenated vegetable oil additive', 'Oat-RUTF contained oats and no hydrogenated vegetable oil additives', 'oat-RUTF']","['Rates of weight', 'rates of growth, time to graduation and presence of adverse events', 'Death, hospitalisation or remaining with SAM']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}, {'cui': 'C1563296', 'cui_str': 'Systolic anterior movement of mitral valve'}, {'cui': 'C0037063', 'cui_str': 'Republic of Sierra Leone'}]","[{'cui': 'C0028753', 'cui_str': 'Oats (substance)'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}, {'cui': 'C0042438', 'cui_str': 'Vegetable Oils'}, {'cui': 'C0982446', 'cui_str': 'Hydrogenated Vegetable Oil'}, {'cui': 'C0442796', 'cui_str': 'Additive (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1563296', 'cui_str': 'Systolic anterior movement of mitral valve'}]",1406.0,0.323655,"Rates of weight in the oat-RUTF group were greater than in the s-RUTF group; 3.4±2.7 versus 2.5±2.3 g/kg/d, p<0.001. CONCLUSION ","[{'ForeName': 'David Taylor', 'Initials': 'DT', 'LastName': 'Hendrixson', 'Affiliation': 'Pediatrics, Washington University in Saint Louis, St Louis, Missouri, USA.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Godbout', 'Affiliation': 'Pediatrics, Washington University in Saint Louis, St Louis, Missouri, USA.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Los', 'Affiliation': 'Pediatrics, Washington University in Saint Louis, St Louis, Missouri, USA.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Callaghan-Gillespie', 'Affiliation': 'Pediatrics, Washington University in Saint Louis, St Louis, Missouri, USA.'}, {'ForeName': 'Melody', 'Initials': 'M', 'LastName': 'Mui', 'Affiliation': 'Pediatrics, Washington University in Saint Louis, St Louis, Missouri, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Wegner', 'Affiliation': 'Pediatrics, Washington University in Saint Louis, St Louis, Missouri, USA.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Bryant', 'Affiliation': 'MANA Nutrition, Fitzgerald, Georgia, USA.'}, {'ForeName': 'Aminata', 'Initials': 'A', 'LastName': 'Koroma', 'Affiliation': 'Directorate of Nutrition, Sierra Leone Ministry of Health and Sanitation, Freetown, Sierra Leone.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Manary', 'Affiliation': 'Pediatrics, Washington University School of Medicine, St Louis, Missouri, USA manary@kids.wustl.edu.'}]",Gut,['10.1136/gutjnl-2020-320769'] 4232,32047021,TULIP: a randomised controlled trial of surgical versus non-surgical treatment of lateral compression injuries of the pelvis with complete sacral fractures (LC1) in the non-fragility fracture patient-a feasibility study protocol.,"INTRODUCTION Lateral compression type 1 (LC1) pelvic fractures are the most common type of pelvic fracture. The majority of LC1 fractures are considered stable. Fractures where a complete sacral fracture is present increases the degree of potential instability and have the potential to displace over time. Non-operative management of these unstable fractures may involve restricted weight bearing and significant rehabilitation. Frequent monitoring with X-rays is also necessary for displacement of the fracture. Operative stabilisation of these fractures may be appropriate to prevent displacement of the fracture. This may allow patients to mobilise pain-free, quicker. METHODS AND ANALYSIS The study is a feasibility study to inform the design of a full definitive randomised controlled trial to guide the most appropriate management of these injuries. Participants will be recruited from major trauma centres and randomly allocated to either operative or non-operative management of their injuries. A variety of outcome instruments, measuring health-related quality of life, functional outcome and pain, will be completed at several time points up to 12 months post injury. Qualitative interviews will be undertaken with participants to explore their views of the treatments under investigation and trial processes.Eligibility and recruitment to the study will be analysed to inform the feasibility of a definitive trial. Completion rates of the measurement instruments will be assessed, as well as their sensitivity to change and the presence of floor or ceiling effects in this population, to inform the choice of the primary outcome for a definitive trial. ETHICS AND DISSEMINATION Ethical approval for the study was given by the South West-Central Bristol NHS Research Ethics Committee on 2nd July 2018 (Ref; 18/SW/0135). The study will be reported in relevant specialist journals and through presentation at specialist conferences. TRIAL REGISTRATION NUMBER ISRCTN10649958.",2020,"A variety of outcome instruments, measuring health-related quality of life, functional outcome and pain, will be completed at several time points up to 12 months post injury.",['Participants will be recruited from major trauma centres'],"['TULIP', 'operative or non-operative management of their injuries', 'surgical versus non-surgical treatment of lateral compression injuries of the pelvis with complete sacral fractures (LC1']","['health-related quality of life, functional outcome and pain']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}]","[{'cui': 'C0331680', 'cui_str': 'Tulip'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C2363849', 'cui_str': 'Non-surgical treatment'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0332679', 'cui_str': 'Pressure injury'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.126724,"A variety of outcome instruments, measuring health-related quality of life, functional outcome and pain, will be completed at several time points up to 12 months post injury.","[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Barnfield', 'Affiliation': 'Department of Trauma & Orthopaedics, North Bristol NHS Trust, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Ingram', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK jenny.ingram@bristol.ac.uk.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Halliday', 'Affiliation': 'Department of Trauma & Orthopaedics, North Bristol NHS Trust, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Griffin', 'Affiliation': 'Nuffield Dept of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), Kadoorie Centre, John Radcliffe Hospital, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Greenwood', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Level 3 Education Centre, Bristol, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Kandiyali', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Department of Anaesthetics, North Bristol NHS Trust, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Glynn', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Beasant', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McArthur', 'Affiliation': 'Department of Orthopaedics, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bates', 'Affiliation': 'Department of Orthopaedics, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Mehool', 'Initials': 'M', 'LastName': 'Acharya', 'Affiliation': 'Department of Trauma & Orthopaedics, North Bristol NHS Trust, Southmead Hospital, Bristol, UK.'}]",BMJ open,['10.1136/bmjopen-2019-036588'] 4233,32029499,Effect of once weekly folic acid supplementation on erythrocyte folate concentrations in women to determine potential to prevent neural tube defects: a randomised controlled dose-finding trial in Malaysia.,"INTRODUCTION Folic acid (0.4 mg) taken prior to and during early pregnancy reduces the risk of neural tube defects (NTDs). Because these birth defects occur early in pregnancy, before women may know they are pregnant, many countries have mandated the addition of folic acid to food staples. In countries where fortification is not possible, and weekly iron folic acid programmes exist to reduce anaemia, the WHO recommends that 2.8 mg (7×0.4 mg) folic acid be given instead of the current weekly practice of 0.4 mg. Currently, there is a lack of evidence to support if the 2.8 mg folic acid per week dose is sufficient to raise erythrocyte folate concentrations to a level associated with a reduced risk of a NTD-affected pregnancy. We aim to conduct a three-arm randomised controlled trial to determine the effect of weekly folic acid with iron on erythrocyte folate, a biomarker of NTD risk. METHODS AND ANALYSIS We will recruit non-pregnant women (n=300; 18-45 years) from Selangor, Malaysia. Women will be randomised to receive either 2.8, 0.4 or 0.0 (placebo) mg folic acid with 60 mg iron weekly for 16 weeks, followed by a 4-week washout period. The primary outcome will be erythrocyte folate concentration at 16 weeks and the mean concentration will be compared between randomised treatment groups (intention-to-treat) using a linear regression model adjusting for the baseline measure. ETHICS AND DISSEMINATION Ethical approval was obtained from the University of British Columbia (H18-00768) and Universiti Putra Malaysia (JKEUPM-2018-255). The results of this trial will be presented at scientific conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBERS ACTRN12619000818134 and NMRR-19-119-45736.",2020,"INTRODUCTION Folic acid (0.4 mg) taken prior to and during early pregnancy reduces the risk of neural tube defects (NTDs).","['women to determine potential to prevent neural tube defects', 'non-pregnant women (n=300; 18-45 years) from Selangor, Malaysia']","['Folic acid', 'folic acid', '0.0 (placebo) mg folic acid', 'folic acid supplementation']","['erythrocyte folate concentrations', 'erythrocyte folate concentration']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0027794', 'cui_str': 'Developmental Defects, Neural Tube'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0024552', 'cui_str': 'Federation of Malaya'}]","[{'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0556110', 'cui_str': 'Folic acid supplementation (product)'}]","[{'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.504137,"INTRODUCTION Folic acid (0.4 mg) taken prior to and during early pregnancy reduces the risk of neural tube defects (NTDs).","[{'ForeName': 'Kaitlyn L I', 'Initials': 'KLI', 'LastName': 'Samson', 'Affiliation': 'Food, Nutrition, and Health, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Su Peng', 'Initials': 'SP', 'LastName': 'Loh', 'Affiliation': 'Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'Geok Lin', 'Initials': 'GL', 'LastName': 'Khor', 'Affiliation': 'Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'Zalilah', 'Initials': 'Z', 'LastName': 'Mohd Shariff', 'Affiliation': 'Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'Lisa N', 'Initials': 'LN', 'LastName': 'Yelland', 'Affiliation': 'School of Public Health, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Shalem', 'Initials': 'S', 'LastName': 'Leemaqz', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Makrides', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Hutcheon', 'Affiliation': ""Healthy Starts, BC Children's Hospital Research Institute, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Dian C', 'Initials': 'DC', 'LastName': 'Sulistyoningrum', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.'}, {'ForeName': 'Jessica J', 'Initials': 'JJ', 'LastName': 'Yu', 'Affiliation': 'Food, Nutrition, and Health, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Marion L', 'Initials': 'ML', 'LastName': 'Roche', 'Affiliation': 'Global Technical Services, Nutrition International, Ottawa, Ontario, Canada.'}, {'ForeName': 'Luz Maria', 'Initials': 'LM', 'LastName': 'De-Regil', 'Affiliation': 'Global Technical Services, Nutrition International, Ottawa, Ontario, Canada.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Green', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.'}, {'ForeName': 'Crystal D', 'Initials': 'CD', 'LastName': 'Karakochuk', 'Affiliation': 'Food, Nutrition, and Health, University of British Columbia, Vancouver, British Columbia, Canada Crystal.Karakochuk@ubc.ca.'}]",BMJ open,['10.1136/bmjopen-2019-034598'] 4234,31106381,"Effects on resident work hours, sleep duration, and work experience in a randomized order safety trial evaluating resident-physician schedules (ROSTERS).","STUDY OBJECTIVES We compared resident physician work hours and sleep in a multicenter clustered-randomized crossover clinical trial that randomized resident physicians to an Extended Duration Work Roster (EDWR) with extended-duration (≥24 hr) shifts or a Rapidly Cycling Work Roster (RCWR), in which scheduled shift lengths were limited to 16 or fewer consecutive hours. METHODS Three hundred two resident physicians were enrolled and completed 370 1 month pediatric intensive care unit rotations in six US academic medical centers. Sleep was objectively estimated with wrist-worn actigraphs. Work hours and subjective sleep data were collected via daily electronic diary. RESULTS Resident physicians worked fewer total hours per week during the RCWR compared with the EDWR (61.9 ± 4.8 versus 68.4 ± 7.4, respectively; p < 0.0001). During the RCWR, 73% of work hours occurred within shifts of ≤16 consecutive hours. In contrast, during the EDWR, 38% of work hours occurred on shifts of ≤16 consecutive hours. Resident physicians obtained significantly more sleep per week on the RCWR (52.9 ± 6.0 hr) compared with the EDWR (49.1 ± 5.8 hr, p < 0.0001). The percentage of 24 hr intervals with less than 4 hr of actigraphically measured sleep was 9% on the RCWR and 25% on the EDWR (p < 0.0001). CONCLUSIONS RCWRs were effective in reducing weekly work hours and the occurrence of >16 consecutive hour shifts, and improving sleep duration of resident physicians. Although inclusion of the six operational healthcare sites increases the generalizability of these findings, there was heterogeneity in schedule implementation. Additional research is needed to optimize scheduling practices allowing for sufficient sleep prior to all work shifts.Clinical Trial: Multicenter Clinical Trial of Limiting Resident Work Hours on ICU Patient Safety (ROSTERS), https://clinicaltrials.gov/ct2/show/NCT02134847.",2019,"Resident physicians obtained significantly more sleep per week on the RCWR (52.9±6.0 hours) compared to the EDWR (49.1±5.8 hours, p<0.0001).",['302 resident physicians were enrolled and completed 370 one-month pediatric intensive care unit rotations in six U.S. academic medical centers'],['Extended Duration Work Roster (EDWR) with extended-duration (≥24 hours) shifts or a Rapidly Cycling Work Roster (RCWR'],"['Work hours and subjective sleep data', 'Sleep', 'percentage of 24-hour intervals']","[{'cui': 'C1320928', 'cui_str': 'Resident physician (occupation)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4517743', 'cui_str': 'Three hundred and seventy'}, {'cui': 'C4082115', 'cui_str': 'One month (qualifier value)'}, {'cui': 'C0021710', 'cui_str': 'PICU - Pediatric intensive care unit'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]","[{'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",,0.0379673,"Resident physicians obtained significantly more sleep per week on the RCWR (52.9±6.0 hours) compared to the EDWR (49.1±5.8 hours, p<0.0001).","[{'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Barger', 'Affiliation': ""Department of Medicine and Neurology, Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Sullivan', 'Affiliation': ""Department of Medicine and Neurology, Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Blackwell', 'Affiliation': 'California Pacific Medical Center Research Institute, San Francisco, CA.'}, {'ForeName': 'Conor S', 'Initials': 'CS', 'LastName': ""O'Brien"", 'Affiliation': ""Department of Medicine and Neurology, Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'St Hilaire', 'Affiliation': ""Department of Medicine and Neurology, Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Shadab A', 'Initials': 'SA', 'LastName': 'Rahman', 'Affiliation': ""Department of Medicine and Neurology, Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Andrew J K', 'Initials': 'AJK', 'LastName': 'Phillips', 'Affiliation': ""Department of Medicine and Neurology, Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Qadri', 'Affiliation': ""Department of Medicine and Neurology, Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Kenneth P', 'Initials': 'KP', 'LastName': 'Wright', 'Affiliation': 'Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Segar', 'Affiliation': ""University of Iowa Stead Family Children's Hospital, Iowa City, IA.""}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'McGuire', 'Affiliation': ""Seattle Children's Hospital, Seattle, WA.""}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Vitiello', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'Horacio O', 'Initials': 'HO', 'LastName': 'de la Iglesia', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'Sue E', 'Initials': 'SE', 'LastName': 'Poynter', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, OH.""}, {'ForeName': 'Pearl L', 'Initials': 'PL', 'LastName': 'Yu', 'Affiliation': ""University of Virginia Children's Hospital, Charlottesville, VA.""}, {'ForeName': 'Phyllis', 'Initials': 'P', 'LastName': 'Zee', 'Affiliation': 'Department of Neurology, Northwestern University, Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Sanderson', 'Affiliation': ""Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Ann C', 'Initials': 'AC', 'LastName': 'Halbower', 'Affiliation': ""Children's Hospital Colorado Anschutz Medical Campus, Aurora, CO.""}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Lockley', 'Affiliation': ""Department of Medicine and Neurology, Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Landrigan', 'Affiliation': ""Department of Medicine and Neurology, Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Stone', 'Affiliation': 'California Pacific Medical Center Research Institute, San Francisco, CA.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Czeisler', 'Affiliation': ""Department of Medicine and Neurology, Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Sleep,['10.1093/sleep/zsz110'] 4235,32076966,Comparison of visual quality after Femto-LASIK and TransPRK in patients with low and moderate myopia.,"PURPOSE To compare the visual quality after surgery of femtosecond-assisted laser in situ keratomileusis (Femto-LASIK) and transepithelial photorefractive keratectomy (TransPRK) in low and moderate myopia patients. METHODS A prospective controlled study was performed on 114 eyes of 62 patients with low to moderate myopia, including 64 eyes of 36 cases in Femto-LASIK group and 50 eyes of 26 cases in TransPRK group. The uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA), residual spherical equivalent (SE), wavefront aberration and contrast sensitivity were examined and analyses preoperatively, 1 month and 3 months postoperatively. RESULTS The UCVA over 0.8 was 100% in two groups at 1 month and 3 months postoperatively. Femto-LASIK group (96.49%) had a higher percentage than TransPRK group (67.39%) of UCVA over 1.0 at 1 month postoperatively (p < 0.001), but it was similar in two groups (97.78%, 90.48%) at 3 months postoperatively (p = 0.15). Femto-LASIK group (77.19%, 86.67%) had a higher percentage than TransPRK group (30.43%, 52.38%) of UCVA over 1.2 at 1 month and 3 months postoperatively (p < 0.001, p = 0.001). The SE of Femto-LASIK group was 0.07 ± 0.21 D, 0.02 ± 0.23 D at 1 month and 3 months postoperatively, and of TransPRK group was 0.11 ± 0.31 D, 0.14 ± 0.38 D; two groups had no significant differences (p = 0.57, p = 0.08). The safety index was 2.0 in Femto-LASIK group and 1.6 in TransPRK, while the efficacy index was 1.67 and 0.4, respectively. The vertical coma, spherical and higher-order aberrations of Femto-LASIK group were 0.37 ± 0.54 μm, 0.31 ± 0.27 μm, 0.89 ± 0.49 μm at 1 month postoperatively, and of TransPRK group were 0.12 ± 0.38 μm, 0.14 ± 0.28 μm, 0.71 ± 0.26 μm. There was significant difference between two groups at 1 months postoperatively (p < 0.001, p = 0.001, p = 0.006), but no significant difference at 3 months (p > 0.05). The contrast sensitivity without glare in 18 c/d spatial frequencies of Femto-LASIK group was 1.08 ± 0.26 at 1 month postoperatively, and that in TransPRK group was 0.99 ± 0.22. There was significant difference between two groups (p = 0.02). The contrast sensitivity with glare in 12 c/d and 18 c/d spatial frequencies at 1 month postoperatively had significant differences between Femto-LASIK and TransPRK groups (1.52 ± 0.17, 1.10 ± 0.23 vs 1.38 ± 0.39, 1.00 ± 0.27, p = 0.02, p = 0.03). While there were no significant differences at 3 months postoperatively (p > 0.05). CONCLUSION Femto-LASIK had a higher increase in whole eye higher-order aberrations and contrast sensitivity than TransPRK at 1 month postoperatively, but they were similar at 3 months postoperatively in low and moderate myopia patients.",2020,"While there were no significant differences at 3 months postoperatively (p > 0.05). ","['114 eyes of 62 patients with low to moderate myopia, including 64 eyes of 36 cases in Femto-LASIK group and 50 eyes of 26 cases in TransPRK group', 'patients with low and moderate myopia', 'low and moderate myopia patients']","['femtosecond-assisted laser in situ keratomileusis (Femto-LASIK) and transepithelial photorefractive keratectomy (TransPRK', 'Femto-LASIK', 'Femto-LASIK and TransPRK']","['contrast sensitivity without glare', 'contrast sensitivity with glare', 'UCVA', 'visual quality', 'uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA), residual spherical equivalent (SE), wavefront aberration and contrast sensitivity', 'efficacy index', 'safety index']","[{'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0027092', 'cui_str': 'Nearsightedness'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0752094', 'cui_str': 'Laser-Assisted Stromal In Situ Keratomileusis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0752094', 'cui_str': 'Laser-Assisted Stromal In Situ Keratomileusis'}, {'cui': 'C0395416', 'cui_str': 'Photorefractive Keratectomy'}]","[{'cui': 'C0009928', 'cui_str': 'Visual Contrast Sensitivity'}, {'cui': 'C3887688', 'cui_str': 'Glare (finding)'}, {'cui': 'C1637380', 'cui_str': 'Uncorrected visual acuity'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C1532952', 'cui_str': 'Wavefront aberration'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",62.0,0.0287523,"While there were no significant differences at 3 months postoperatively (p > 0.05). ","[{'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong, Dong Xia North Road, Shantou, Guangdong Province, China.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Jhanji', 'Affiliation': 'Department of Ophthalmology, University of Pittsburgh School of Medicine, Pittsburgh, USA.'}, {'ForeName': 'Lixia', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong, Dong Xia North Road, Shantou, Guangdong Province, China.'}, {'ForeName': 'Jinyu', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong, Dong Xia North Road, Shantou, Guangdong Province, China.'}, {'ForeName': 'Riping', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong, Dong Xia North Road, Shantou, Guangdong Province, China. zrp@jsiec.org.'}]",International ophthalmology,['10.1007/s10792-020-01308-5'] 4236,32060547,"When, How, & Where Tobacco Initiation and Relapse Occur During U.S. Air Force Technical Training.","INTRODUCTION Military personnel are at high risk for tobacco use, particularly during the first year of military service. Technical Training follows an 8½ week tobacco ban during basic military training and is a vulnerable time for personnel to both reinitiate and initiate tobacco use. Thus, this can be a crucial time to promote tobacco policies and interventions. However, there is limited research examining when, how, and where personnel access tobacco during the first year of service, particularly among users of newer products (eg, electronic cigarettes[e-cigarettes]). Thus, the purpose of the current study is to explore the timing, source, and location of tobacco use during Technical Training across all types of products. Furthermore, this study will examine differences in demographic characteristics and prior tobacco history in relationship to these tobacco behaviors. MATERIALS AND METHODS Participants were U.S. Air Force recruits completing Technical Training (2017-2018). Protocol was approved by the Institutional Review Board at the 59th Medical Wing of the U.S. Air Force. During the first week of Technical Training, Airmen were consented to participate in the study and completed a questionnaire about demographics and tobacco use history. Next, Airmen were randomized to receive one of three tobacco prevention interventions as part of military training. At a 3-month follow-up, during the last week of Technical Training, consented participants completed a questionnaire about current tobacco use. Airmen reported when (ie, first month vs. after), how (ie, ""bummed"" from another airman, bought on or off base, received from the internet or event), and where (ie, designated smoking areas on base, off base, bar or club, friend's house, cigar lounge, hookah bar, or vape shop) they used tobacco during Technical Training. Descriptive statistics were used to examine these behaviors across all tobacco products. Additionally, Wilcoxon-Mann-Whitney and Kruskal-Wallis tests compared differences in demographic characteristics and baseline tobacco use in relationship to these tobacco behaviors. RESULTS No significant differences were found when comparing prior users and first-time users in relationship to tobacco behaviors during Technical Training; however, significant differences in educational background and age were found in regard to the source and location of tobacco use. Additionally, how and where Airmen first used tobacco during Technical Training differed across products. Cigarettes and smokeless tobacco were equally likely to be bought on or off base and most commonly first used at a designated smoking area on base. However, e-cigarettes, cigarillos/little cigars, and hookah were more likely to be bought off base, and first used at a specialty store (ie, vape shop, hookah bar, or cigar lounge). CONCLUSIONS Tobacco use behaviors during Technical Training differed depending on the type of product. Specifically, new and emerging products were more likely to be bought off base and first used at a specialty store. Thus, military polices regulating on base tobacco pricing might not reduce the growing prevalence of e-cigarettes. Future policies might consider addressing the density of off-base tobacco retailers to reduce the high rates of tobacco use in this population.",2020,"No significant differences were found when comparing prior users and first-time users in relationship to tobacco behaviors during Technical Training; however, significant differences in educational background and age were found in regard to the source and location of tobacco use.",['Participants were U.S. Air Force recruits completing Technical Training (2017-2018'],['tobacco prevention interventions as part of military training'],['Tobacco Initiation and Relapse Occur'],"[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",,0.0301639,"No significant differences were found when comparing prior users and first-time users in relationship to tobacco behaviors during Technical Training; however, significant differences in educational background and age were found in regard to the source and location of tobacco use.","[{'ForeName': 'Margaret Celice', 'Initials': 'MC', 'LastName': 'Fahey', 'Affiliation': 'Department of Psychology; 400 Innovation Drive, Memphis, TN 38111, USA.'}, {'ForeName': 'G Wayne', 'Initials': 'GW', 'LastName': 'Talcott', 'Affiliation': 'University of Virginia School of Medicine; Center for Addiction and Prevention Research; 560 Ray C. Hunt Drive, Charlottesville, VA 22908, USA.'}, {'ForeName': 'Timothy L', 'Initials': 'TL', 'LastName': 'McMurry', 'Affiliation': 'University of Virginia School of Medicine; Center for Addiction and Prevention Research; 560 Ray C. Hunt Drive, Charlottesville, VA 22908, USA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Klesges', 'Affiliation': 'University of Virginia School of Medicine; Center for Addiction and Prevention Research; 560 Ray C. Hunt Drive, Charlottesville, VA 22908, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tubman', 'Affiliation': 'University of Virginia School of Medicine; Center for Addiction and Prevention Research; 560 Ray C. Hunt Drive, Charlottesville, VA 22908, USA.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Krukowski', 'Affiliation': 'University of Tennessee Health Science Center, Department of Preventive Medicine; 66 N Pauline Street Memphis, TN 38163, USA.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Little', 'Affiliation': 'University of Virginia School of Medicine; Center for Addiction and Prevention Research; 560 Ray C. Hunt Drive, Charlottesville, VA 22908, USA.'}]",Military medicine,['10.1093/milmed/usaa016'] 4237,32048945,Impact of High-Quality Goals-of-Care Discussions on Oncologist Productivity.,"PURPOSE To study factors that have an impact on the conduct of high-quality goals of care (GoC) discussions and productivity of oncologists among four different practice settings in patients with advanced cancer. METHODS Solid-tumor oncologists from community, academic, municipal, and rural hospitals were randomly assigned to receive a coaching model of communication skills to help them facilitate a GoC discussion with newly diagnosed patients with advanced cancer who had a less-than-2-year prognosis. Patients were surveyed after the first restaging visit regarding the quality of the GoC discussion on a scale of 0 to 10 (0, worst; 10, best) with a score of 8 or better indicating a high-quality GoC discussion. Productivity was measured by work revenue value units (wRVUs) per hour for the day each oncologist saw the study patient after imaging. RESULTS The four sites differed significantly in the socioeconomic patient populations they served and in the characteristics of the oncologists who cared for the patients. Overall median productivity across the four sites was 3.6 wRVU/hour, with the highest observed in the community hospital (4.3 wRVU/hour) and the lowest in the rural setting (2.9 wRVU/hour; P < .001). There was no significant difference in productivity observed when high-quality GOC discussion occurred versus when it did not (3.6 v 3.7 wRVU/hour; P = .86). CONCLUSION Despite differences in patient populations and oncologists' characteristics between the four practice settings, the conduct of high-quality GoC discussions did not affect productivity.",2020,"There was no significant difference in productivity observed when high-quality GOC discussion occurred versus when it did not (3.6 v 3.7 wRVU/hour; P = .86). ","['patients with advanced cancer', 'with newly diagnosed patients with advanced cancer who had a less-than-2-year prognosis', 'Solid-tumor oncologists from community, academic, municipal, and rural hospitals']","['High-Quality Goals-of-Care Discussions', 'coaching model of communication skills to help them facilitate a GoC discussion']","['quality GOC discussion', 'Productivity', 'productivity', 'Overall median productivity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0033325', 'cui_str': 'Prognosis'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0020023', 'cui_str': 'Hospitals, Rural'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C2930505', 'cui_str': 'Goals of Care'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.0715195,"There was no significant difference in productivity observed when high-quality GOC discussion occurred versus when it did not (3.6 v 3.7 wRVU/hour; P = .86). ","[{'ForeName': 'Sofya', 'Initials': 'S', 'LastName': 'Pintova', 'Affiliation': 'Tisch Cancer Institute, Department of Medicine, Division of Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Leibrandt', 'Affiliation': 'Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Cardinale B', 'Initials': 'CB', 'LastName': 'Smith', 'Affiliation': 'Tisch Cancer Institute, Department of Medicine, Division of Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Kerin B', 'Initials': 'KB', 'LastName': 'Adelson', 'Affiliation': 'Smilow Cancer Hospital at Yale, New Haven, CT.'}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Gonsky', 'Affiliation': 'Department of Medicine, Division of Hematology and Medical Oncology, New York City Health and Hospitals/Kings County and State University of New York Downstate Medical School, Brooklyn, NY.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Egorova', 'Affiliation': 'Department of Population Health Science and Policy at Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Rebeca', 'Initials': 'R', 'LastName': 'Franco', 'Affiliation': 'New York University School of Medicine, New York, NY.'}, {'ForeName': 'Nina A', 'Initials': 'NA', 'LastName': 'Bickell', 'Affiliation': 'Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY.'}]",JCO oncology practice,['10.1200/JOP.19.00381'] 4238,32052831,"A Randomized Controlled Trial of Ceftriaxone and Doxycycline, With or Without Metronidazole, for the Treatment of Acute Pelvic Inflammatory Disease.","BACKGROUND Anaerobic organisms are important pathogens in acute pelvic inflammatory disease (PID). The currently recommended PID regimen of a single dose of ceftriaxone and doxycycline for 14 days has limited anaerobic activity. The need for broader anaerobic coverage is unknown and concerns have been raised about metronidazole tolerability. METHODS We conducted a randomized, double-blind, placebo-controlled trial comparing ceftriaxone 250 mg intramuscular single dose and doxycycline for 14 days, with or without 14 days of metronidazole in women with acute PID. The primary outcome was clinical improvement at 3 days following enrollment. Additional outcomes at 30 days following treatment were the presence of anaerobic organisms in the endometrium, clinical cure (absence of fever and reduction in tenderness), adherence, and tolerability. RESULTS We enrolled 233 women (116 to metronidazole and 117 to placebo). Clinical improvement at 3 days was similar between the 2 groups. At 30 days following treatment, anaerobic organisms were less frequently recovered from the endometrium in women treated with metronidazole than placebo (8% vs 21%, P < .05) and cervical Mycoplasma genitalium was reduced (4% vs 14%, P < .05). Pelvic tenderness was also less common among women receiving metronidazole (9% vs 20%, P < .05). Adverse events and adherence were similar in each treatment group. CONCLUSIONS In women treated for acute PID, the addition of metronidazole to ceftriaxone and doxycycline was well tolerated and resulted in reduced endometrial anaerobes, decreased M. genitalium, and reduced pelvic tenderness compared to ceftriaxone and doxycycline. Metronidazole should be routinely added to ceftriaxone and doxycycline for the treatment of women with acute PID. CLINICAL TRIALS REGISTRATION NCT01160640.",2021,"Pelvic tenderness was also less common among women receiving metronidazole (9% vs 20%, p<0.01).","['233 women (116 to', 'acute pelvic inflammatory disease (PID', 'women with acute PID', 'Acute Pelvic Inflammatory Disease']","['Metronidazole', 'Ceftriaxone and Doxycycline, with or Without Metronidazole', 'ceftriaxone', 'metronidazole and 117 to placebo', 'placebo', 'ceftriaxone and doxycycline', 'metronidazole', 'doxycycline']","['Adverse events and adherence', 'cervical Mycoplasma genitalium', 'reduced endometrial anaerobes, decreased M. genitalium and reduced pelvic tenderness', 'Pelvic tenderness', 'presence of anaerobic organisms in the endometrium, clinical cure (absence of fever and reduction in tenderness), adherence and tolerability']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0149959', 'cui_str': 'Acute pelvic inflammatory disease (disorder)'}]","[{'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0317872', 'cui_str': 'Mycoplasma genitalium'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0004613', 'cui_str': 'Bacteria, Anaerobic'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0029235', 'cui_str': 'Organism - attribute'}, {'cui': 'C0014180', 'cui_str': 'Endometrium'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0277797', 'cui_str': 'Apyrexial'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",233.0,0.392636,"Pelvic tenderness was also less common among women receiving metronidazole (9% vs 20%, p<0.01).","[{'ForeName': 'Harold C', 'Initials': 'HC', 'LastName': 'Wiesenfeld', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'Meyn', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Darville', 'Affiliation': 'Department of Pediatrics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Ingrid S', 'Initials': 'IS', 'LastName': 'Macio', 'Affiliation': 'Magee-Womens Research Institute, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Hillier', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa101'] 4239,32020631,The effectiveness of early position change postcardiac catheterization on patient's outcomes: A randomized controlled trial.,"BACKGROUND Nurses play a substantial role in maintaining patient homeostasis postcardiac catheterization. Patients frequently complain of back pain and discomfort as a result of the prolonged bed rest postcatheterization. AIM This study aims to evaluate the effectiveness of early position change postcardiac catheterization on reducing patients' pain and discomfort. SETTINGS The study was conducted at two cardiac units in a university hospital in Jordan. PARTICIPANTS A total of 120 patients were used in the study, 60 patients in each of the two groups-control and intervention. METHODS The randomized controlled trial design was used. Data were initially collected 1 hour after sheath removal postcardiac catheterization. After that, the protocol was applied to the interventional group. RESULTS Early position change 1 hour after sheath removal after cardiac catheterization was found to be effective in reducing back pain as compared with the control group (P < .001). Also, the study intervention was found to be effective in reducing urinary discomfort (X 2  = 50.83, P < .001), and increasing comfort level (X 2  = 120, P < .001). However, although participants in the intervention group were less likely to have constipation and hematoma than those in the control group, this outcome was not statistically significant at P > .05. CONCLUSION Early position change 1 hour after sheath removal postcardiac catheterization has significant positive effects on patient outcomes by reducing the intensity of back pain and urination problems and increasing patients' comfort level without increasing incidents of vascular complications such as bleeding and hematoma.",2020,"Also, the study intervention was found to be effective in reducing urinary discomfort (X 2  = 50.83, P < .001), and increasing comfort level (X 2  = 120, P < .001).","['two cardiac units in a university hospital in Jordan', 'A total of 120 patients were used in the study, 60 patients in each of the two groups-control and intervention']",['early position change postcardiac catheterization'],"['constipation and hematoma', 'comfort level', ""patients' pain and discomfort"", 'back pain', 'urinary discomfort', 'complain of back pain and discomfort', 'intensity of back pain and urination problems']","[{'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0022418', 'cui_str': 'Jordan'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0444793', 'cui_str': 'Position change (qualifier value)'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}]","[{'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0517225', 'cui_str': 'Comfort level'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]",120.0,0.0830214,"Also, the study intervention was found to be effective in reducing urinary discomfort (X 2  = 50.83, P < .001), and increasing comfort level (X 2  = 120, P < .001).","[{'ForeName': 'Rashid K', 'Initials': 'RK', 'LastName': 'Ibdah', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': ""Wafa'a F"", 'Initials': 'WF', 'LastName': ""Ta'an"", 'Affiliation': 'Department of Community and Mental Health Nursing, Faculty of Nursing, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Rawan M', 'Initials': 'RM', 'LastName': 'Shatnawi', 'Affiliation': 'Nursing Department, King Abdullah University Hospital, Irbid, Jordan.'}, {'ForeName': 'Mohammad M', 'Initials': 'MM', 'LastName': 'Suliman', 'Affiliation': 'Department of Community and Mental Health Nursing, Faculty of Nursing, Al al-Bayt University, Mafraq, Jordan.'}, {'ForeName': 'Jehad A', 'Initials': 'JA', 'LastName': 'Rababah', 'Affiliation': 'Department of Adults Health Nursing, Faculty of Nursing, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Sukaina I', 'Initials': 'SI', 'LastName': 'Rawashdeh', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Jordan University of Science and Technology, Irbid, Jordan.'}]",Nursing forum,['10.1111/nuf.12438'] 4240,31993665,"Age and time-of-day differences in the hypothalamo-pituitary-testicular, and adrenal, response to total overnight sleep deprivation.","STUDY OBJECTIVES In young men, sleep restriction decreases testosterone (Te) and increases afternoon cortisol (F), leading to anabolic-catabolic imbalance, insulin resistance, and other andrological health consequences. Age-related differences in the hypothalamo-pituitary-testicular/adrenal response to sleep restriction could expose older individuals to greater or lesser risk. We aimed to evaluate and compare the 24-h and time-of-day effect of sleep restriction on F, luteinizing hormone (LH), and Te in young and older men. METHODS Thirty-five healthy men, aged 18-30 (n = 17) and 60-80 (n =18) years, underwent overnight sleep deprivation (complete nighttime wakefulness) or nighttime sleep (10 pm to 6 am) with concurrent 10-min blood sampling in a prospectively randomized crossover study. F, LH, and Te secretion were calculated by deconvolution analysis. RESULTS Sleep deprivation had multiple effects on 24-h Te secretion with significant reductions in mean concentrations, basal, total and pulsatile secretion, and pulse frequency (each p < 0.05), in the absence of detectable changes in LH. These effects were most apparent in older men and differed according to age for some parameters: pulsatile Te secretion (p = 0.03) and Te pulse frequency (p = 0.02). Time-of-day analyses revealed that sleep restriction significantly reduced Te in the morning and afternoon, reduced LH in the morning in both age groups, and increased F in the afternoon in older men. CONCLUSIONS These data suggest a time-of-day dependent uncoupling of the regulatory control of the testicular axis and of F secretion. Future studies will need to directly verify these regulatory possibilities specifically and separately in young and older men. CLINICAL TRIAL Not applicable.",2020,These effects were most apparent in older men and differed according to age for some parameters: pulsatile Te secretion (P=0.03) and Te pulse frequency (P=0.02).,"['older men', 'Thirty-five healthy men, aged 18-30 (n=17) and 60-80 (n=18) years, underwent', 'young and older men']","['sleep restriction on F, luteinizing hormone (LH) and Te', 'overnight sleep deprivation (complete nighttime wakefulness) or nighttime sleep (10PM to 6AM) with concurrent 10-minute blood sampling']","['mean concentrations, basal, total and pulsatile secretion, and pulse frequency', 'F, LH and Te secretion', '24-hour Te secretion', 'sleep restriction decreases testosterone (Te) and increases afternoon cortisol (F), leading to anabolic-catabolic imbalance, insulin resistance, and other andrological health consequences']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0023607', 'cui_str': 'Luteinizing Hormone'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0037316', 'cui_str': 'Sleep Deprivation'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0043012', 'cui_str': 'Wakefulnesses'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0005834', 'cui_str': 'Blood Specimen Collection'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439606', 'cui_str': 'Pulsatile (qualifier value)'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0439550', 'cui_str': 'Afternoon (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",35.0,0.0246444,These effects were most apparent in older men and differed according to age for some parameters: pulsatile Te secretion (P=0.03) and Te pulse frequency (P=0.02).,"[{'ForeName': 'Peter Y', 'Initials': 'PY', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, David Geffen School of Medicine at UCLA, Los Angeles, CA.'}, {'ForeName': 'Paul Y', 'Initials': 'PY', 'LastName': 'Takahashi', 'Affiliation': 'Department of Primary Care Internal Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Yang', 'Affiliation': 'Endocrine Research Unit, Mayo School of Graduate Medical Education, Center for Translational Science Activities, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Iranmanesh', 'Affiliation': 'Endocrine Service, Salem Veterans Affairs Medical Center, Salem, VA.'}, {'ForeName': 'Johannes D', 'Initials': 'JD', 'LastName': 'Veldhuis', 'Affiliation': 'Endocrine Research Unit, Mayo School of Graduate Medical Education, Center for Translational Science Activities, Mayo Clinic, Rochester, MN.'}]",Sleep,['10.1093/sleep/zsaa008'] 4241,32193861,Watching Videos of Colonoscopies and Receiving Interpretations Reduce Pain and Anxiety While Increasing the Satisfaction of Patients.,"BACKGROUND Pain associated with colonoscopies is a major barrier to patients participating in colorectal cancer screenings. While sedation and analgesia are used to reduce pain during the procedure, they are associated with increased complications and costs. Thus, it is necessary to identity novel techniques to relieve pain in a safe and cost-effective way. AIMS To test whether watching real-time videos of colonoscopies while receiving detailed interpretations of the procedures reduces pain and anxiety and increases a patient's satisfaction. METHODS Patients were randomized into three groups including a group who watched real-time videos of their colonoscopies (Group A), a group who watched real-time videos of their colonoscopies while receiving detailed interpretations of the procedures from the endoscopists (Group B), and a group who did not receive either method (Group C). RESULTS Pain and anxiety scores were significantly (Group A vs. Group C, [Formula: see text]; Group B vs. Group C, [Formula: see text]) lower in Groups A and B compared to Group C. Additionally, significantly (Group A vs. Group C, [Formula: see text]; Group B vs. Group C, [Formula: see text]) increased satisfaction was observed in Groups A and B compared to Group C. There were no statistically significant differences observed in the pain and anxiety scores when comparing Groups A and B. However, the overall satisfaction score was significantly ([Formula: see text]) higher in Group B compared to Group A. CONCLUSIONS Real-time videos of colonoscopies as well as videos along with detailed interpretations of the procedures decrease pain and anxiety while improving satisfaction in patients undergoing colonoscopies without sedation. Videos combined with interpretations lead to a greater increase in patient satisfaction.",2021,There were no statistically significant differences observed in the pain and anxiety scores when comparing Groups A and B.,"['Patients', 'patients participating in colorectal cancer screenings', 'patients undergoing colonoscopies without sedation']","['watched real-time videos of their colonoscopies (Group A), a group who watched real-time videos of their colonoscopies while receiving detailed interpretations of the procedures from the endoscopists (Group B), and a group who did not receive either method (Group C']","['Pain and Anxiety', 'pain and anxiety', 'Pain and anxiety scores', 'satisfaction', 'patient satisfaction', 'overall satisfaction score', 'pain', 'pain and anxiety scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0459471', 'cui_str': 'Interpretation (attribute)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0400544,There were no statistically significant differences observed in the pain and anxiety scores when comparing Groups A and B.,"[{'ForeName': 'Li-Ping', 'Initials': 'LP', 'LastName': 'Sheng', 'Affiliation': 'Department of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China.'}, {'ForeName': 'Chao-Qun', 'Initials': 'CQ', 'LastName': 'Han', 'Affiliation': 'Department of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China.'}, {'ForeName': 'Chi', 'Initials': 'C', 'LastName': 'Nie', 'Affiliation': 'Department of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Department of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China.'}, {'ForeName': 'Xuan-Ji', 'Initials': 'XJ', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China.'}, {'ForeName': 'Xin-Ru', 'Initials': 'XR', 'LastName': 'Xie', 'Affiliation': 'Department of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Lin', 'Affiliation': 'Department of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Ding', 'Affiliation': 'Department of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China. docd720@126.com.'}]",Digestive diseases and sciences,['10.1007/s10620-020-06186-6'] 4242,32149854,Abdominoplasty With Scarpa Fascia Preservation: Prospective Comparative Study of Suction Drain Number.,"BACKGROUND Abdominoplasty is becoming increasingly more common, with seroma being the most frequent complication. Suction drains are used very often as a method to prevent seroma formation, and it has been suggested that techniques using Scarpa fascia preservation and closed-suction drains have lower seroma rates than other approaches. However few studies have addressed parameters that may affect drain efficiency. A prospective comparative study was conducted to determine if applying 2 or 3 closed-suction drains, after an abdominoplasty with Scarpa fascia preservation, has any effect on several outcomes. METHODS This was a single-center study conducted from September 2016 to March 2019. Patients were allocated according to choice to 1 of the 2 surgeons involved in the study, each responsible for 1 group: abdominoplasty with Scarpa fascia preservation with 2 closed-suction drains placed postoperatively (group A) or with 3 closed-suction drains (group B). A comparative analysis of selected variables was done between both groups, including time to drain removal, total and daily drain output, duration of hospital stay, emergency department visit, readmission to the hospital, secondary surgical procedure, and incidence of postoperative local and systemic complications. RESULTS A total of 73 abdominoplasties with Scarpa fascia preservation were performed in women (group A, 33 patients; group B, 40 patients). General characteristics of group A and B were similar. There were no statistically significant differences between groups in any of the determined variables, namely, main outcomes (total and daily drain output, time to drain removal) or complications (local or systemic). CONCLUSIONS Our results suggest that using 3 closed-suction drains postabdominoplasty with Scarpa fascia preservation has no advantages in total and daily drain output, time to drain removal, or complications when compared with the usual 2 drains approach.",2020,"There were no statistically significant differences between groups in any of the determined variables, namely, main outcomes (total and daily drain output, time to drain removal) or complications (local or systemic). ","['73 abdominoplasties with Scarpa fascia preservation were performed in women (group A, 33 patients; group B, 40 patients']","['3 closed-suction drains', 'Suction drains', 'abdominoplasty with Scarpa fascia preservation with 2 closed-suction drains placed postoperatively (group A) or with 3 closed-suction drains', 'Suction Drain Number']","['main outcomes (total and daily drain output, time to drain removal) or complications (local or systemic', 'total and daily drain output, time to drain removal, or complications', 'seroma rates', 'time to drain removal, total and daily drain output, duration of hospital stay, emergency department visit, readmission to the hospital, secondary surgical procedure, and incidence of postoperative local and systemic complications']","[{'cui': 'C0198542', 'cui_str': 'Abdominoplasty'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}]","[{'cui': 'C0441139', 'cui_str': 'Suction drain (physical object)'}, {'cui': 'C0198542', 'cui_str': 'Abdominoplasty'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]","[{'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0411815', 'cui_str': 'Removal of drain (procedure)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",73.0,0.0598204,"There were no statistically significant differences between groups in any of the determined variables, namely, main outcomes (total and daily drain output, time to drain removal) or complications (local or systemic). ","[{'ForeName': 'Andreia', 'Initials': 'A', 'LastName': 'Pisco', 'Affiliation': 'From the Department of Surgery and Physiology, Porto University Medical School.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Rebelo', 'Affiliation': 'Plastic Surgery Department, IPO Porto.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Peres', 'Affiliation': 'Interdisciplinary Centre of Marine and Environmental Research (CIIMAR) and Science Faculty, Porto University.'}, {'ForeName': 'António', 'Initials': 'A', 'LastName': 'Costa-Ferreira', 'Affiliation': ''}]",Annals of plastic surgery,['10.1097/SAP.0000000000002349'] 4243,30885799,Design and recruitment of the randomized order safety trial evaluating resident-physician schedules (ROSTERS) study.,"INTRODUCTION While the Accreditation Council for Graduate Medical Education limited first year resident-physicians to 16 consecutive work hours from 2011 to 2017, resident-physicians in their second year or higher were permitted to work up to 28 h consecutively. This paper describes the Randomized Order Safety Trial Evaluating Resident-physician Schedules (ROSTERS) study, a clustered-randomized crossover clinical trial designed to evaluate the effectiveness of eliminating traditional shifts of 24 h or longer for second year or higher resident-physicians in pediatric intensive care units (PICUs). METHODS ROSTERS was a multi-center non-blinded trial in 6 PICUs at US academic medical centers. The primary aim was to compare patient safety between the extended duration work roster (EDWR), which included shifts ≥24 h, and a rapidly cycling work roster (RCWR), where shifts were limited to a maximum of 16 h. Information on potential medical errors was gathered and used for classification by centrally trained physician reviewers who were blinded to the study arm. Secondary aims were to assess the relationship of the study arm to resident-physician sleep duration, work hours and neurobehavioral performance. RESULTS The study involved 6577 patients with a total of 38,821 patient days (n = 18,749 EDWR, n = 20,072 RCWR). There were 413 resident-physician rotations included in the study (n = 203 EDWR, n = 210 RCWR). Resident-physician questionnaire data were over 95% complete. CONCLUSIONS Results from data collected in the ROSTERS study will be evaluated for the impact of resident-physician schedule roster on patient safety outcomes in PICUs, and will allow for examination of a number of secondary outcome measures. ClinicalTrials.gov Identifier: NCT02134847.",2019,"The primary aim was to compare patient safety between the extended duration work roster (EDWR), which included shifts ≥24 h, and a rapidly cycling work roster (RCWR), where shifts were limited to a maximum of 16 h. Information on potential medical errors was gathered and used for classification by centrally trained physician reviewers who were blinded to the study arm.","['pediatric intensive care units (PICUs', 'There were 413 resident-physician rotations included in the study (n\u202f=\u202f203 EDWR, n\u202f=\u202f210 RCWR', '6577 patients with a total of 38,821 patient days (n\u202f=\u202f18,749 EDWR, n\u202f=\u202f20,072 RCWR', 'ROSTERS was a multi-center non-blinded trial in 6 PICUs at US academic medical centers']","['traditional shifts of 24\u202fh or longer for second year or higher resident-physicians', 'extended duration work roster (EDWR), which included shifts ≥24\u202fh, and a rapidly cycling work roster (RCWR']","['patient safety', 'resident-physician sleep duration, work hours and neurobehavioral performance', 'Resident-physician questionnaire data']","[{'cui': 'C0021710', 'cui_str': 'PICU - Pediatric intensive care unit'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C1320928', 'cui_str': 'Resident physician (occupation)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1320928', 'cui_str': 'Resident physician (occupation)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]","[{'cui': 'C1113679'}, {'cui': 'C1320928', 'cui_str': 'Resident physician (occupation)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",6577.0,0.144238,"The primary aim was to compare patient safety between the extended duration work roster (EDWR), which included shifts ≥24 h, and a rapidly cycling work roster (RCWR), where shifts were limited to a maximum of 16 h. Information on potential medical errors was gathered and used for classification by centrally trained physician reviewers who were blinded to the study arm.","[{'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Blackwell', 'Affiliation': 'California Pacific Medical Center Research Institute, San Francisco, CA, USA. Electronic address: tblackwell@sfcc-cpmc.net.'}, {'ForeName': 'Dana R', 'Initials': 'DR', 'LastName': 'Kriesel', 'Affiliation': 'California Pacific Medical Center Research Institute, San Francisco, CA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vittinghoff', 'Affiliation': 'University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Conor S', 'Initials': 'CS', 'LastName': ""O'Brien"", 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Sullivan', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Natalie C', 'Initials': 'NC', 'LastName': 'Viyaran', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Shadab A', 'Initials': 'SA', 'LastName': 'Rahman', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA; Division of Sleep Medicine, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Lockley', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA; Division of Sleep Medicine, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Barger', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA; Division of Sleep Medicine, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Ann C', 'Initials': 'AC', 'LastName': 'Halbower', 'Affiliation': ""Children's Hospital Colorado Anschutz Medical Campus, Aurora, CO, USA.""}, {'ForeName': 'Sue E', 'Initials': 'SE', 'LastName': 'Poynter', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, OH, USA.""}, {'ForeName': 'Kenneth P', 'Initials': 'KP', 'LastName': 'Wright', 'Affiliation': 'Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, USA.'}, {'ForeName': 'Pearl L', 'Initials': 'PL', 'LastName': 'Yu', 'Affiliation': ""University of Virginia Children's Hospital, Charlottesville, VA, USA.""}, {'ForeName': 'Phyllis C', 'Initials': 'PC', 'LastName': 'Zee', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Landrigan', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA; Division of Sleep Medicine, Harvard Medical School, Boston, MA, USA; Division of General Pediatrics, Department of Medicine, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Czeisler', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA; Division of Sleep Medicine, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Stone', 'Affiliation': 'California Pacific Medical Center Research Institute, San Francisco, CA, USA; University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2019.03.005'] 4244,32007604,"Stepped Treatment for Attention-Deficit/Hyperactivity Disorder and Aggressive Behavior: A Randomized, Controlled Trial of Adjunctive Risperidone, Divalproex Sodium, or Placebo After Stimulant Medication Optimization.","OBJECTIVE Stimulant medications are the most prevalent first-line pharmacotherapy for attention-deficit/hyperactivity disorder, but children with aggressive behavior often receive multiagent treatment. There is sparse evidence for the benefits of adjunctive medications when stimulant monotherapy provides inadequate benefit for aggressive behavior, yet the adverse effects of common adjuncts are well established. This study compared the efficacy in reducing aggressive behavior of risperidone (RISP), divalproex sodium (DVPX), and placebo (PBO) added to stimulant medication among childrenwhose symptoms persisted after individually optimized stimulant treatment. METHOD This trial enrolled 6- to 12-year-old with attention-deficit/hyperactivity disorder, a disruptive disorder, significant aggressive behavior, and prior stimulant treatment. Open, systematically titrated stimulant treatment identified patients with inadequate reductions in aggressive behavior, who were then randomly assigned to receive adjunctive RISP, DVPX, or PBO under double-blinded conditions for 8 weeks. Family-based behavioral treatment was offered throughout the trial. The primary outcome was the parent-completed Retrospective Modified Overt Aggression Scale. RESULTS Participants included 175 children (mean [SD] age 9.48 [2.04] years, 19% female). Of participants, 151 completed the stimulant optimization phase, with aggression remitting among 96 (63%), and 45 were randomly assigned to adjunctive treatment groups. The adjunctive RISP group showed greater reductions in aggression ratings than the PBO group (least squares means difference [ΔLSM], -2.33; 95% CI, -3.83 to -0.82; effect size [ES], -1.32), as did the DVPX group (ΔLSM, -1.60; 95% CI, -3.18 to -0.03; ES, -0.91). Mean standardized body mass index scores increased more among RISP-treated participants than participants receiving PBO (ΔLSM, 1.54; 95% CI, 0.68 to 2.40; ES, 0.58). CONCLUSION High response rate during the trial's open stimulant optimization phase suggests that rigorous titration of stimulant medication and concurrent behavioral therapy may avert the need for additional medications. Among nonremitters, RISP and DVPX were efficacious adjunctive treatments, although RISP was associated with weight gain. CLINICAL TRIAL REGISTRATION INFORMATION Effectiveness of Combined Medication Treatment for Aggression in Children With Attention Deficit With Hyperactivity Disorder (The SPICY Study); https://www.clinicaltrials.gov; NCT00794625.",2021,"Among nonremitters, RISP and DVPX were efficacious adjunctive treatments although RISP was associated with weight gain.","['children whose symptoms persisted after individually-optimized stimulant treatment', 'Attention-Deficit/Hyperactivity Disorder and Aggressive Behavior', 'patients with inadequate reductions in aggressive behavior', '175 children participated, mean [sd] age 9.48', '151 participants completed the stimulant optimization phase, with aggression remitting among 96 (63%), and 45', 'enrolled 6-12-year-olds with ADHD, a disruptive disorder, significant aggressive behavior, and prior stimulant treatment']","['risperidone (RISP), divalproex sodium (DVPX), and placebo (PBO', 'Adjunctive Risperidone, Divalproex Sodium, or Placebo', 'adjunctive RISP, DVPX, or PBO']","['weight gain', 'parent-completed Retrospective-Modified Overt Aggression Scale', 'aggression ratings', 'Mean standardized body mass index scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439600', 'cui_str': 'Remitting (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]","[{'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0886883', 'cui_str': 'Divalproex Sodium'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0222045'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",175.0,0.308042,"Among nonremitters, RISP and DVPX were efficacious adjunctive treatments although RISP was associated with weight gain.","[{'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Blader', 'Affiliation': 'University of Texas Health Science Center, San Antonio. Electronic address: blader@uthscsa.edu.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Pliszka', 'Affiliation': 'University of Texas Health Science Center, San Antonio.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Kafantaris', 'Affiliation': 'Zucker Hillside Hospital and the Feinstein Institute for Medical Research, Manhasset, New York.'}, {'ForeName': 'Carmel A', 'Initials': 'CA', 'LastName': 'Foley', 'Affiliation': ""Cohen Children's Medical Center of New York, Divisions of Northwell Health, Manhasset, New York.""}, {'ForeName': 'Gabrielle A', 'Initials': 'GA', 'LastName': 'Carlson', 'Affiliation': 'Renaissance School of Medicine, Stony Brook University, New York.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Crowell', 'Affiliation': 'Renaissance School of Medicine, Stony Brook University, New York.'}, {'ForeName': 'Brigitte Y', 'Initials': 'BY', 'LastName': 'Bailey', 'Affiliation': 'University of Texas Health Science Center, San Antonio.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Sauder', 'Affiliation': 'Adams Clinical, Watertown, Massachusetts.'}, {'ForeName': 'W Burleson', 'Initials': 'WB', 'LastName': 'Daviss', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire.'}, {'ForeName': 'Christa', 'Initials': 'C', 'LastName': 'Sinha', 'Affiliation': 'Renaissance School of Medicine, Stony Brook University, New York.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Matthews', 'Affiliation': 'University of Texas Health Science Center, San Antonio.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Margulies', 'Affiliation': 'Renaissance School of Medicine, Stony Brook University, New York.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.12.009'] 4245,32088746,Prospective evaluation of fexapotide triflutate injection treatment of Grade Group 1 prostate cancer: 4-year results.,"PURPOSE This study was undertaken to determine the safety and efficacy of fexapotide triflutate (FT) 2.5 mg and 15 mg for the treatment of Grade Group 1 prostate cancer. METHODS Prospective randomized transrectal intraprostatic single injection FT 2.5 mg (n = 49), FT 15 mg (n = 48) and control active surveillance (AS) (n = 49) groups were compared in 146 patients at 28 U.S. sites, with elective AS crossover (n = 18) to FT after first follow-up biopsy at 45 days. Patients were followed for 5 years including biopsies (baseline, 45 days, and 18, 36, and 54 months thereafter), and urological evaluations with PSA every 6 months. Patients with Gleason grade increase or who elected surgical or radiotherapeutic intervention exited the study and were cumulatively included in the data analysis. Percentage of normal biopsies in baseline focus quadrant, tumor grades, and volumes; and outcomes including Gleason grade in entire prostate as well as treated prostate lobe, interventions associated with Gleason grade increase and total incidence of interventions were assessed. RESULTS Significantly improved long-term clinical outcomes were found after 4-year follow-up, with percentages of patients progressing to interventions with and without Gleason grade increase significantly reduced by FT single treatment. Results in the FT 15-mg group were superior to the FT 2.5-mg dose group. There were no drug-related serious adverse events (SAEs). CONCLUSIONS FT showed statistically significant long-term efficacy in the treatment of Grade Group 1 patients regarding clinical and pathological progression. FT 15 mg showed superior results to FT 2.5 mg. There were no drug-related SAEs; FT injection was well tolerated.",2020,"RESULTS Significantly improved long-term clinical outcomes were found after 4-year follow-up, with percentages of patients progressing to interventions with and without Gleason grade increase significantly reduced by FT single treatment.","['Patients with Gleason grade increase or who elected surgical or radiotherapeutic intervention exited the study and were cumulatively included in the data analysis', 'Grade Group 1 prostate cancer']","['transrectal intraprostatic single injection FT 2.5\xa0mg (n\u2009=\u200949), FT 15\xa0mg (n\u2009=\u200948) and control active surveillance (AS', 'fexapotide triflutate (FT', 'fexapotide triflutate injection']","['long-term clinical outcomes', 'tolerated', 'Gleason grade increase and total incidence of interventions', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0337094', 'cui_str': 'Exit (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C0205518', 'cui_str': 'Transrectal approach (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1827061', 'cui_str': 'Active surveillance'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",146.0,0.0170791,"RESULTS Significantly improved long-term clinical outcomes were found after 4-year follow-up, with percentages of patients progressing to interventions with and without Gleason grade increase significantly reduced by FT single treatment.","[{'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Shore', 'Affiliation': 'Carolina Urologic Research Center, Myrtle Beach, SC, USA. NShore@gsuro.com.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Kaplan', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Tutrone', 'Affiliation': 'Chesapeake Urology Research Associates, Baltimore, MD, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Levin', 'Affiliation': 'Chesapeake Urology Research Associates, Towson, MD, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Bailen', 'Affiliation': 'First Urology, Louisville, KY, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Hay', 'Affiliation': 'Willamette Urology, Salem, OR, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Kalota', 'Affiliation': 'Urological Associates of Southern Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Bidair', 'Affiliation': 'San Diego Clinical Trials, San Diego, CA, USA.'}, {'ForeName': 'Sheldon', 'Initials': 'S', 'LastName': 'Freedman', 'Affiliation': 'Freedman Urology, Las Vegas, NV, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Goldberg', 'Affiliation': 'UT Southwestern Department of Urology, Lewisville, TX, USA.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Snoy', 'Affiliation': 'Urology Group of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Jonathan I', 'Initials': 'JI', 'LastName': 'Epstein', 'Affiliation': 'Johns Hopkins Medical Institutions, Baltimore, MD, USA.'}]",World journal of urology,['10.1007/s00345-020-03127-w'] 4246,32040809,Operative Results and Perioperative Morbidity After Intensified Neoadjuvant Chemotherapy with FLOT for Gastroesophageal Adenocarcinoma Impact of Intensified Neoadjuvant Treatment.,"BACKGROUND Perioperative treatment is the standard of care in Western Europe for locally advanced gastric cancer (GC) and adenocarcinoma of the gastroesophageal junction (GEJ). Intensified neoadjuvant treatment within the NeoFLOT trial proved to be safe and effective. Yet, the influence of such intensification with 6 cycles of FLOT in the neoadjuvant setting has not been analyzed regarding its possible impact on perioperative results. MATERIALS AND METHODS A total of 537 patients were enrolled in this study; of whom, 132 had followed a standard neoadjuvant protocol (CTx), 356 had not received any neoadjuvant treatment (NoCTx), and 49 patients had undergone an intensified chemotherapy within the NeoFLOT trial (IntCTx) with 6 cycles of FLOT (5-FU, leucovorin, oxaliplatin, docetaxel) every 2 weeks. RESULTS Our results reveal no significant difference in perioperative morbidity or mortality with regard to the neoadjuvant treatment. Postoperative bleeding and hematoma occurred less frequently in the IntCTx group compared to the NoCTx and the CTx groups (2.0% vs. 5.33% vs. 5.1%). Postoperative lymph fistulas were slightly more frequent in the IntCTx group (4.1% vs. 0.3% vs. 1.6%). Patients treated within the NeoFLOT trial had a higher risk for blood transfusions (OR 5.5; 95%-KI, 2.49-12.19), whereas patients without neoadjuvant therapy had the longest ICU stay (mean 8.3 vs. CTx 4.5 vs. IntCTx 6.7 days). CONCLUSION The results of the current study indicate that also an intensification of neoadjuvant chemotherapy with 6 preoperative cycles of FLOT does not significantly increase perioperative complications. Thus, prolonged neoadjuvant chemotherapy with FLOT is safe for patients with locally advanced GC or GEJ tumors.",2021,Postoperative bleeding and hematoma occurred less frequently in the IntCTx group compared to the NoCTx and the CTx groups (2.0% vs. 5.33% vs. 5.1%).,"['patients with locally advanced GC or GEJ tumors', 'locally advanced gastric cancer (GC) and adenocarcinoma of the gastroesophageal junction (GEJ', '537 patients were enrolled in this study; of whom, 132 had followed a standard neoadjuvant protocol (CTx), 356 had not received any neoadjuvant treatment (NoCTx), and 49 patients had undergone an intensified chemotherapy within the NeoFLOT trial (IntCTx) with 6\xa0cycles of']","['FLOT (5-FU, leucovorin, oxaliplatin, docetaxel', 'FLOT', 'IntCTx']","['Postoperative lymph fistulas', 'higher risk for blood transfusions', 'Postoperative bleeding and hematoma', 'perioperative morbidity or mortality', 'longest ICU stay', 'perioperative complications', 'Perioperative Morbidity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C1332166', 'cui_str': 'Adenocarcinoma of the gastroesophageal junction'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant Treatment'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0340791', 'cui_str': 'Lymph fistula (disorder)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}]",537.0,0.055554,Postoperative bleeding and hematoma occurred less frequently in the IntCTx group compared to the NoCTx and the CTx groups (2.0% vs. 5.33% vs. 5.1%).,"[{'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Ganschow', 'Affiliation': 'Department of General, Visceral and Transplant Surgery, Ludwig-Maximilians University, Marchionini Str. 15, 81377, Munich, Germany. petra.ganschow@med.uni-muenchen.de.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Hofmann', 'Affiliation': 'Department of General, Visceral and Transplant Surgery, Ludwig-Maximilians University, Marchionini Str. 15, 81377, Munich, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Stintzing', 'Affiliation': 'Department of Medical Oncology, Klinikum Grosshadern and Comprehensive Cancer Center, University of Munich, Marchionini Str. 15, 81377, Munich, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Department of Medical Oncology, Klinikum Grosshadern and Comprehensive Cancer Center, University of Munich, Marchionini Str. 15, 81377, Munich, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Angele', 'Affiliation': 'Department of General, Visceral and Transplant Surgery, Ludwig-Maximilians University, Marchionini Str. 15, 81377, Munich, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Werner', 'Affiliation': 'Department of General, Visceral and Transplant Surgery, Ludwig-Maximilians University, Marchionini Str. 15, 81377, Munich, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Schulz', 'Affiliation': 'Department of Medical Oncology, Klinikum Grosshadern and Comprehensive Cancer Center, University of Munich, Marchionini Str. 15, 81377, Munich, Germany.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-019-04511-7'] 4247,31899564,Counseling alone or in combination with nicotine replacement therapy for treatment of black non-daily smokers: a randomized trial.,"BACKGROUND AND AIMS One-third of US tobacco users are non-daily smokers (NDS). Black NDS have strikingly high levels of nicotine and carcinogen exposure. No smoking cessation studies have been conducted with this high-risk group. This study compared the effectiveness in black NDS of smoking cessation counseling alone or in combination with the participant's choice of nicotine replacement therapy. DESIGN Two-arm parallel-group individually randomized clinical trial (allocation ratio of 2 : 1 intervention to control) SETTING: Academic medical and federally qualified health centers in three US cities. PARTICIPANTS Non-Hispanic black adult NDS receiving counseling with nicotine replacement therapy (C + NRT, n = 185) or counseling alone (C, n = 93). INTERVENTIONS Twelve weeks of in-person and telephone smoking cessation counseling in combination with nicotine replacement therapy (NRT; C + NRT) or counseling alone (C). All participants received five sessions of counseling; those randomized to C + NRT received their choice of nicotine gum, patch and/or lozenge after a 9-day product trial period. The target quit day was set at 2 weeks post-baseline for both groups. MEASUREMENTS Primary outcome was biochemically verified 30-day abstinence at week 12. Secondary outcomes were change in nicotine and carcinogen exposure [4-(methynitrosamino)-1-(3) pyridyle-1-butanol; NNAL] and tobacco consumption patterns. FINDINGS Abstinence was 11.4% in C + NRT and 8.6% in C [odds ratio (OR) = 1.4, 95% confidence interval (CI) = 0.6, 3.2, P = 0.48]. Both groups experienced significant reduction in NNAL (C + NRT: 53% reduction, C: 50% reduction, within-group P < 0.0001) but non-significant changes in cotinine (P = 0.69). C + NRT reported more days abstinent (P < 0.001) and fewer total cigarettes (P = 0.002) compared with C. There was no evidence of compensation with other tobacco products. CONCLUSIONS Among black non-daily smokers in the United States, there was no difference in abstinence between nicotine replacement therapy (NRT) and counseling alone. NRT led to greater increase in days abstinent and reduction in cigarettes, with no evidence of compensation from other sources of nicotine.",2020,C+NRT reported more days abstinent (p<.001) and fewer total cigarettes (p=.002) compared with C.,"[' Academic medical and federally qualified health centers in 3 US cities PARTICIPANTS: Non-Hispanic black adult NDS receiving counseling with', 'black non-daily smokers']","['nicotine replacement therapy (NRT', 'nicotine replacement therapy', 'NRT', 'Counseling alone or in combination with nicotine replacement therapy', 'nicotine replacement therapy (C+NRT, n=185) or counseling alone (C, n=93', 'telephone smoking cessation counseling in combination with nicotine replacement therapy [NRT; C+NRT', 'nicotine gum, patch, and/or lozenge', 'counseling alone [C', 'C+NRT']","['change in nicotine and carcinogen exposure [4-(methynitrosamino) -1-(3) pyridyle-1-butanol; NNAL] and tobacco consumption patterns', 'NNAL', 'total cigarettes', 'biochemically-verified 30-day abstinence']","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1378701', 'cui_str': 'Gum (basic dose form)'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C4319836', 'cui_str': 'Lozenge'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C4521889', 'cui_str': 'Carcinogen (disposition)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0089147', 'cui_str': '1-Butanol'}, {'cui': 'C0543414', 'cui_str': 'Tobacco Chewing'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.160448,C+NRT reported more days abstinent (p<.001) and fewer total cigarettes (p=.002) compared with C.,"[{'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Nollen', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Kansas School of Medicine, Kansas City, KS, USA.'}, {'ForeName': 'Lisa Sanderson', 'Initials': 'LS', 'LastName': 'Cox', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Kansas School of Medicine, Kansas City, KS, USA.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Mayo', 'Affiliation': 'Department of Biostatistics and Data Science, University of Kansas School of Medicine, Kansas City, KS, USA.'}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'Ellerbeck', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Kansas School of Medicine, Kansas City, KS, USA.'}, {'ForeName': 'Jasjit S', 'Initials': 'JS', 'LastName': 'Ahluwalia', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.14948'] 4248,32050090,"Accelerated surgery versus standard care in hip fracture (HIP ATTACK): an international, randomised, controlled trial.","BACKGROUND Observational studies have suggested that accelerated surgery is associated with improved outcomes in patients with a hip fracture. The HIP ATTACK trial assessed whether accelerated surgery could reduce mortality and major complications. METHODS HIP ATTACK was an international, randomised, controlled trial done at 69 hospitals in 17 countries. Patients with a hip fracture that required surgery and were aged 45 years or older were eligible. Research personnel randomly assigned patients (1:1) through a central computerised randomisation system using randomly varying block sizes to either accelerated surgery (goal of surgery within 6 h of diagnosis) or standard care. The coprimary outcomes were mortality and a composite of major complications (ie, mortality and non-fatal myocardial infarction, stroke, venous thromboembolism, sepsis, pneumonia, life-threatening bleeding, and major bleeding) at 90 days after randomisation. Patients, health-care providers, and study staff were aware of treatment assignment, but outcome adjudicators were masked to treatment allocation. Patients were analysed according to the intention-to-treat principle. This study is registered at ClinicalTrials.gov (NCT02027896). FINDINGS Between March 14, 2014, and May 24, 2019, 27 701 patients were screened, of whom 7780 were eligible. 2970 of these were enrolled and randomly assigned to receive accelerated surgery (n=1487) or standard care (n=1483). The median time from hip fracture diagnosis to surgery was 6 h (IQR 4-9) in the accelerated-surgery group and 24 h (10-42) in the standard-care group (p<0·0001). 140 (9%) patients assigned to accelerated surgery and 154 (10%) assigned to standard care died, with a hazard ratio (HR) of 0·91 (95% CI 0·72 to 1·14) and absolute risk reduction (ARR) of 1% (-1 to 3; p=0·40). Major complications occurred in 321 (22%) patients assigned to accelerated surgery and 331 (22%) assigned to standard care, with an HR of 0·97 (0·83 to 1·13) and an ARR of 1% (-2 to 4; p=0·71). INTERPRETATION Among patients with a hip fracture, accelerated surgery did not significantly lower the risk of mortality or a composite of major complications compared with standard care. FUNDING Canadian Institutes of Health Research.",2020,"Among patients with a hip fracture, accelerated surgery did not significantly lower the risk of mortality or a composite of major complications compared with standard care. ","['69 hospitals in 17 countries', 'Patients with a hip fracture that required surgery and were aged 45 years or older were eligible', 'patients with a hip fracture', 'Between March 14, 2014, and May 24, 2019, 27\u2008701 patients were screened, of whom 7780 were eligible']","['Accelerated surgery versus standard care', 'accelerated surgery (n=1487) or standard care', 'central computerised randomisation system using randomly varying block sizes to either accelerated surgery (goal of surgery within 6 h of diagnosis) or standard care']","['mortality and a composite of major complications (ie, mortality and non-fatal myocardial infarction, stroke, venous thromboembolism, sepsis, pneumonia, life-threatening bleeding, and major bleeding', 'mortality and major complications', 'median time from hip fracture diagnosis', 'Major complications', 'risk of mortality or a composite of major complications']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0521110', 'cui_str': 'Accelerated (contextual qualifier) (qualifier value)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",27701.0,0.169736,"Among patients with a hip fracture, accelerated surgery did not significantly lower the risk of mortality or a composite of major complications compared with standard care. ","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30058-1'] 4249,32075845,Efficacy and safety of a supplement combination for hand osteoarthritis pain: protocol for an internet-based randomised placebo-controlled trial (The RADIANT study).,"INTRODUCTION Hand osteoarthritis (HOA) is a highly prevalent disabling joint disease. The current management regimens are limited. Potentially as a consequence, many people turn to complementary and alternative medicines for symptomatic relief. A combination of two or more supplements is common in clinical practice; however, evidence for the efficacy of this approach is lacking. The aim of this study is to investigate the efficacy of a supplement combination for treating symptomatic HOA in comparison to placebo. METHODS AND ANALYSIS The RADIANT study is an internet-based, parallel, superiority, double-blind, placebo-controlled, randomised, two-arm clinical trial. A participatory design is used to facilitate the study procedures. One hundred and six participants aged over 40 years with painful HOA and structural change on X-ray (Kellgren and Lawrence grade (KLG) ≥2) will be recruited from the community and randomly allocated to receive either a supplement combination composed of: (1) combined supplement containing Boswellia serrata extract, pine bark extract and methylsulfonylmethane and (2) curcumin or placebo for 12 weeks. The primary outcome will be 12-week change in hand pain on a visual analogue scale (VAS). Main secondary outcomes include adverse events, change in hand function, patient global assessment of disease activity and quality of life. A range of additional measures will be recorded, and an individual patient placebo response will be performed. The primary analysis will be conducted using an intention-to-treat approach. Adverse events will be monitored weekly throughout the study. ETHICS AND DISSEMINATION This protocol has been approved by the University of Sydney Human Research Ethics Committee (HREC No. 2018/766). Dissemination will occur through conferences, social media, scientific publications and PhD thesis. TRIAL REGISTRATION NUMBER Australian New Zealand Clinical Trials Registry (ACTRN12619000835145); Pre-results.",2020,One hundred and six participants aged over 40 years with painful HOA and structural change on X-ray (Kellgren and Lawrence grade (KLG) ≥2) will be recruited from the community and randomly allocated to receive either a supplement combination composed of: (1) combined supplement containing ,"['hand osteoarthritis pain', 'One hundred and six participants aged over 40 years with painful HOA and structural change on X-ray (Kellgren and Lawrence grade (KLG) ≥2']","['placebo', 'supplement combination', 'Boswellia serrata extract, pine bark extract and methylsulfonylmethane and (2) curcumin or placebo', 'supplement combination composed of: (1) combined supplement containing']","['12-week change in hand pain on a visual analogue scale (VAS', 'Efficacy and safety', 'adverse events, change in hand function, patient global assessment of disease activity and quality of life', 'Adverse events']","[{'cui': 'C0263746', 'cui_str': 'Degenerative joint disease of hand (disorder)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0649652', 'cui_str': 'Benzenamine, 4-(hexyloxy)-'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2608032', 'cui_str': 'Boswellia serrata'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0872909', 'cui_str': 'pine bark extract'}, {'cui': 'C0058231', 'cui_str': 'dimethyl sulfone'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0239833', 'cui_str': 'Hand pain (finding)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0562230', 'cui_str': 'Hand functions (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0034380'}]",106.0,0.623007,One hundred and six participants aged over 40 years with painful HOA and structural change on X-ray (Kellgren and Lawrence grade (KLG) ≥2) will be recruited from the community and randomly allocated to receive either a supplement combination composed of: (1) combined supplement containing ,"[{'ForeName': 'Xiaoqian', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Northern Clinical School, Institute of Bone and Joint Research, Kolling Institute of Medical Research, Rheumatology Department, Royal North Shore Hospital, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Robbins', 'Affiliation': 'Northern Clinical School, Institute of Bone and Joint Research, Kolling Institute of Medical Research, Rheumatology Department, Royal North Shore Hospital, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Eyles', 'Affiliation': 'Northern Clinical School, Institute of Bone and Joint Research, Kolling Institute of Medical Research, Rheumatology Department, Royal North Shore Hospital, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia.'}, {'ForeName': 'Tatyana', 'Initials': 'T', 'LastName': 'Fedorova', 'Affiliation': 'Northern Clinical School, Institute of Bone and Joint Research, Kolling Institute of Medical Research, Rheumatology Department, Royal North Shore Hospital, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sonika', 'Initials': 'S', 'LastName': 'Virk', 'Affiliation': 'Northern Clinical School, Institute of Bone and Joint Research, Kolling Institute of Medical Research, Rheumatology Department, Royal North Shore Hospital, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia.'}, {'ForeName': 'Leticia A', 'Initials': 'LA', 'LastName': 'Deveza', 'Affiliation': 'Northern Clinical School, Institute of Bone and Joint Research, Kolling Institute of Medical Research, Rheumatology Department, Royal North Shore Hospital, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McLachlan', 'Affiliation': 'School of Pharmacy, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hunter', 'Affiliation': 'Northern Clinical School, Institute of Bone and Joint Research, Kolling Institute of Medical Research, Rheumatology Department, Royal North Shore Hospital, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia david.hunter@sydney.edu.au.'}]",BMJ open,['10.1136/bmjopen-2019-035672'] 4250,32046793,The effect of postprandial glycaemia on cognitive function: a randomised crossover trial.,"The effect on cognitive test scores of generating differences in postprandial glycaemia using test foods or beverages has been inconsistent. Methodological issues may account for some of the variable results requiring further investigation using strong study designs into the relationship between glycaemia and cognitive functioning. The objective of this study was to determine the effects of postprandial glycaemia on cognitive function by examining cognition after consumption of foods that differ only by the rate of digestion of available carbohydrate in a population of young adults. In a double-blind, randomised, crossover trial, sixty-five participants received trifle sweetened either with a higher-glycaemic index (GI) sugar (sucrose; GI 65) or a lower-GI sugar (isomaltulose; GI 34). Cognitive tests were completed prior to trifle consumption, and 60 and 120 min after. There was no between-trifle difference at 60 min in performance on free word recall (0·0 (95 % CI -0·6, 0·5)), short delay word recall (0·0 (95 % CI -0·5, 0·5)), long delay word recall (0·0 (95 % CI -0·6, 0·6)), letter-number sequence recall (0·3 (95 % CI - 0·2, 0·7)) and visuo-spatial recall (-0·2 (95 % CI -0·6, 0·2)) tests. At 120 min, no difference was detected in any of these tests. The participants performed 7·7 (95 % CI 0·5,14·9) s faster in Reitan's trail-making test B 60 min after the higher-GI trifle than the lower-GI trifle (P = 0·037). Our findings of a null effect on memory are generally consistent with other works in which blinding and robust control for confounding have been used.",2020,"The participants performed 7.7, 95% CI (0.5,14.9) seconds faster in Reitan's trail-making test B 60 minutes after the higher GI trifle than the lower GI trifle (P=0.037).",['population of young adults'],"['trifle sweetened either with a higher glycaemic index (GI) sugar (sucrose; GI 65) or a lower GI sugar (isomaltulose; GI 34', 'postprandial glycaemia']",['cognitive function'],"[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0453568', 'cui_str': 'Trifle (substance)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0064002', 'cui_str': 'isomaltulose anhydrous'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}]",65.0,0.35211,"The participants performed 7.7, 95% CI (0.5,14.9) seconds faster in Reitan's trail-making test B 60 minutes after the higher GI trifle than the lower GI trifle (P=0.037).","[{'ForeName': 'Olivia M', 'Initials': 'OM', 'LastName': 'Marchand', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin9054, New Zealand.'}, {'ForeName': 'Fiona E', 'Initials': 'FE', 'LastName': 'Kendall', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin9054, New Zealand.'}, {'ForeName': 'Charlene M', 'Initials': 'CM', 'LastName': 'Rapsey', 'Affiliation': 'Department of Psychological Medicine, Otago Medical School, University of Otago, Dunedin9054, New Zealand.'}, {'ForeName': 'Jillian J', 'Initials': 'JJ', 'LastName': 'Haszard', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin9054, New Zealand.'}, {'ForeName': 'Bernard J', 'Initials': 'BJ', 'LastName': 'Venn', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin9054, New Zealand.'}]",The British journal of nutrition,['10.1017/S0007114520000458'] 4251,31389731,Impact of cyclosporin treatment on health-related quality of life of patients with alopecia areata.,"INTRODUCTION Alopecia areata (AA) is a disfiguring disease with substantial psychological burden. No studies explore the efficacy of pharmacotherapy through health-related quality of life (HRQoL) using both disease-specific and generic quality of life (QoL) instruments. We present the first study to elicit health utility from patients with AA and to evaluate the efficacy of cyclosporin in relation to HRQoL using both measures. METHODS Participants with moderate to severe AA from a placebo-controlled randomized trial investigating cyclosporin were administered the generic preference-based HRQoL instrument, Assessment of Quality of Life-8D (AQoL-8D) and the disease-specific HRQoL instrument, Alopecia Areata Symptom Impact Scale (AASIS). HRQoL was measured at each study visit and compared to baseline. RESULTS A number of 32 participants were analyzed. The mean health utility was 0.748. At 3 months, the cyclosporin group had trends for greater improvement in HRQoL across 6 of 8 AQoL-8D dimensions and 5 of 7 AASIS symptom domains compared to placebo. HRQoL was lower than Australian population norms across 6 of 8 AQoL-8D dimensions. CONCLUSIONS Patients with AA had a mean health utility of 0.748. Treatment with cyclosporin 4 mg/kg/d for 3 months resulted in trends for improvement of HRQoL across multiple dimensions in both disease-specific and generic measures. Capsule summary The mean health utility for patients with AA was 0.748. Patients with alopecia areata have impaired health-related quality of life across 6 of 8 AQoL-8D dimensions compared to population norms. Treatment with oral cyclosporin for moderate to severe AA resulted in trends for improvement in QoL across multiple dimensions.",2021,Treatment with cyclosporin 4 mg/kg/d for 3 months resulted in trends for improvement of HRQoL across multiple dimensions in both disease-specific and generic measures.,"['Patients with alopecia areata', 'Patients with AA', 'patients with AA', 'Participants with moderate to severe AA from a', 'patients with alopecia areata']","['oral cyclosporin', 'placebo', 'cyclosporin']","['Alopecia areata (AA', 'health-related quality of life', 'mean health utility', 'HRQoL', 'Quality of Life-8D (AQoL-8D) and the disease-specific HRQoL instrument, Alopecia Areata Symptom Impact Scale (AASIS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002171', 'cui_str': 'Alopecia Circumscripta'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0002171', 'cui_str': 'Alopecia Circumscripta'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0222045'}]",32.0,0.0378071,Treatment with cyclosporin 4 mg/kg/d for 3 months resulted in trends for improvement of HRQoL across multiple dimensions in both disease-specific and generic measures.,"[{'ForeName': 'Vivien Wai Yun', 'Initials': 'VWY', 'LastName': 'Lai', 'Affiliation': 'Faculty of Medicine, Nursing and Health Sciences, Monash School of Medicine, Monash University, Clayton, Australia.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Centre for Health Economics, Monash Business School, Monash University, Clayton, Australia.'}, {'ForeName': 'Rodney', 'Initials': 'R', 'LastName': 'Sinclair', 'Affiliation': 'Sinclair Dermatology, East Melbourne, Australia.'}]",The Journal of dermatological treatment,['10.1080/09546634.2019.1654068'] 4252,31540863,"Impact of a Behavioral Intervention on Diet, Eating Patterns, Self-Efficacy, and Social Support.","OBJECTIVE To examine the effectiveness of a structured multimodal behavioral intervention to change dietary behaviors, as well as self-efficacy and social support for engaging in healthier diets. METHODS A quasi-experimental design was used to assign sites into intervention and comparison groups. Data were collected at baseline, 3 months, and 6 months. The intervention group participated in Texercise Select, a 12-week lifestyle enhancement program. Multiple mixed-effects models were used to examine nutrition-related changes over time. RESULTS For the intervention group, significant improvements were observed for fast food consumption (P = .011), fruit/vegetable consumption (P = .008), water consumption (P = .009), and social support (P < .001) from baseline to 3 months. The magnitude of these improvements was significantly greater than changes in the comparison group. CONCLUSIONS AND IMPLICATIONS Findings suggest the intervention's ability to improve diet-related outcomes among older adults; however, additional efforts are needed to maintain changes over longer periods.",2020,"For the intervention group, significant improvements were observed for fast food consumption (P = .011), fruit/vegetable consumption (P = .008), water consumption (P = .009), and social support (P < .001) from baseline to 3 months.",['older adults'],"['structured multimodal behavioral intervention', 'Texercise Select, a 12-week lifestyle enhancement program', 'Behavioral Intervention']","['fast food consumption', 'water consumption', 'Diet, Eating Patterns, Self-Efficacy, and Social Support', 'fruit/vegetable consumption', 'social support']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0344355', 'cui_str': 'Convenience Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0013123', 'cui_str': 'Water Intake'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0037438'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}]",,0.0112083,"For the intervention group, significant improvements were observed for fast food consumption (P = .011), fruit/vegetable consumption (P = .008), water consumption (P = .009), and social support (P < .001) from baseline to 3 months.","[{'ForeName': 'Matthew Lee', 'Initials': 'ML', 'LastName': 'Smith', 'Affiliation': 'Center for Population Health and Aging, Texas A&M University, College Station, TX; Department of Environmental and Occupational Health, School of Public Health, Texas A&M University, College Station, TX; Department of Health Promotion and Behavior, College of Public Health, The University of Georgia, Athens, GA. Electronic address: matthew.smith@tamu.edu.'}, {'ForeName': 'Shinduk', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Center for Population Health and Aging, Texas A&M University, College Station, TX.'}, {'ForeName': 'Samuel D', 'Initials': 'SD', 'LastName': 'Towne', 'Affiliation': 'Center for Population Health and Aging, Texas A&M University, College Station, TX; Department of Environmental and Occupational Health, School of Public Health, Texas A&M University, College Station, TX; Department of Health Management & Informatics, University of Central Florida, Orlando, FL; Aging & Technology Faculty Cluster Initiative, University of Central Florida, Orlando, FL.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Han', 'Affiliation': 'Department of Epidemiology & Biostatistics, School of Public Health, Texas A&M University, College Station, TX.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Quinn', 'Affiliation': 'Center for Population Health and Aging, Texas A&M University, College Station, TX.'}, {'ForeName': 'Ninfa C', 'Initials': 'NC', 'LastName': 'Peña-Purcell', 'Affiliation': 'Center for Population Health and Aging, Texas A&M University, College Station, TX; Department of Environmental and Occupational Health, School of Public Health, Texas A&M University, College Station, TX; Family and Community Health, AgriLife Extension Service, Texas A&M University, College Station, TX.'}, {'ForeName': 'Marcia G', 'Initials': 'MG', 'LastName': 'Ory', 'Affiliation': 'Center for Population Health and Aging, Texas A&M University, College Station, TX; Department of Environmental and Occupational Health, School of Public Health, Texas A&M University, College Station, TX.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2019.06.008'] 4253,31364474,Feasibility and efficacy of a web-based family telehealth nutrition intervention to improve child weight status and dietary intake: A pilot randomised controlled trial.,"INTRODUCTION Innovative eHealth solutions that improve access to child weight management interventions are crucial to address the rising prevalence of childhood obesity globally. The study aimed to evaluate the feasibility and preliminary efficacy of a 12-week online telehealth nutrition intervention to improve child weight and dietary outcomes, and the impact of additional text messages (SMS) targeted to mothers and fathers. METHODS Families with children aged 4 to 11 were randomised across three groups: Telehealth, Telehealth+SMS, or Waitlist control. Telehealth and Telehealth+SMS groups received two telehealth consultations delivered by a dietitian, 12 weeks access to a nutrition website and a private Facebook group. The Telehealth+SMS group received additional SMS. Feasibility was assessed through recruitment, retention, and intervention utilisation. Efficacy was assessed through changes in measured child body mass index (BMI), waist circumference and diet. RESULTS Forty-four (96%) and 36 (78%) families attended initial and second telehealth consultations, respectively. Thirty-six families (78%) completed week 12 assessments. Child BMI and waist circumference changes from baseline to week 12 were not statistically different within or between groups. Children in Telehealth+SMS had significantly reduced percentage energy from energy-dense nutrient-poor food (95% CI -21.99 to -0.03%E; p  = .038) and increased percentage energy from healthy core food (95% CI -0.21 to 21.89%E; p  = .045) compared to Waitlist control. DISCUSSION A family-focused online telehealth nutrition intervention is feasible. While the modest sample size reduced power to detect between-group changes in weight status, some improvements in child dietary intakes were identified in those receiving telehealth and SMS.",2021,,[],['web-based family telehealth nutrition intervention'],"['Feasibility and efficacy', 'child weight status and dietary intake']",[],"[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}]",,0.0748469,,"[{'ForeName': 'Li Kheng', 'Initials': 'LK', 'LastName': 'Chai', 'Affiliation': 'School of Health Sciences, Faculty of Health and Medicine, The University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Clare E', 'Initials': 'CE', 'LastName': 'Collins', 'Affiliation': 'School of Health Sciences, Faculty of Health and Medicine, The University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'May', 'Affiliation': 'School of Health Sciences, Faculty of Health and Medicine, The University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Ashman', 'Affiliation': 'School of Health Sciences, Faculty of Health and Medicine, The University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Holder', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, Australia.'}, {'ForeName': 'Leanne J', 'Initials': 'LJ', 'LastName': 'Brown', 'Affiliation': 'University of Newcastle Department of Rural Health, The University of Newcastle, North Tamworth Australia.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Burrows', 'Affiliation': 'School of Health Sciences, Faculty of Health and Medicine, The University of Newcastle, Callaghan, Australia.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19865855'] 4254,31978214,Early peripheral clearance of leukemia-associated immunophenotypes in AML: centralized analysis of a randomized trial.,"Although genetics is a relevant risk factor in acute myeloid leukemia (AML), it can be minimally informative and/or not readily available for the early identification of patients at risk for treatment failure. In a randomized trial comparing standard vs high-dose induction (ClinicalTrials.gov #NCT00495287), we studied early peripheral blast cell clearance (PBC) as a rapid predictive assay of chemotherapy response to determine whether it correlates with the achievement of complete remission (CR), as well as postremission outcome, according to induction intensity. Individual leukemia-associated immunophenotypes (LAIPs) identified pretherapy by flow cytometry were validated and quantified centrally after 3 days of treatment, expressing PBC on a logarithmic scale as the ratio of absolute LAIP+ cells on day 1 and day 4. Of 178 patients, 151 (84.8%) were evaluable. Patients in CR exhibited significantly higher median PBC (2.3 log) compared with chemoresistant patients (1.0 log; P < .0001). PBC < 1.0 predicted the worst outcome (CR, 28%). With 1.5 log established as the most accurate cutoff predicting CR, 87.5% of patients with PBC >1.5 (PBChigh, n = 96) and 43.6% of patients with PBC ≤1.5 (PBClow, n = 55) achieved CR after single-course induction (P < .0001). CR and PBChigh rates were increased in patients randomized to the high-dose induction arm (P = .04) and correlated strongly with genetic/cytogenetic risk. In multivariate analysis, PBC retained significant predictive power for CR, relapse risk, and survival. Thus, PBC analysis can provide a very early prediction of outcome, correlates with treatment intensity and disease subset, and may support studies of customized AML therapy.",2020,CR and PBChigh rates were increased in patients randomized to the high-dose induction arm (P = .04) and correlated strongly with genetic/cytogenetic risk.,"['acute myeloid leukemia (AML', 'Of 178 patients, 151 (84.8%) were evaluable']",[],"['complete remission (CR', 'CR and PBChigh rates', 'CR, relapse risk, and survival', 'median PBC']","[{'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",178.0,0.0852106,CR and PBChigh rates were increased in patients randomized to the high-dose induction arm (P = .04) and correlated strongly with genetic/cytogenetic risk.,"[{'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Gianfaldoni', 'Affiliation': 'Struttura Organizzativa Dipartimentale (SOD) Ematologia, Università di Firenze, and.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Mannelli', 'Affiliation': 'Struttura Organizzativa Dipartimentale (SOD) Ematologia, Università di Firenze, and.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Intermesoli', 'Affiliation': 'Unità Strutturale Complessa di Ematologia, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Bencini', 'Affiliation': 'Struttura Organizzativa Dipartimentale (SOD) Ematologia, Università di Firenze, and.'}, {'ForeName': 'Damiano', 'Initials': 'D', 'LastName': 'Giupponi', 'Affiliation': 'Unità Strutturale Complessa di Ematologia, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Farina', 'Affiliation': ""Unità Operativa Laboratorio Analisi-Citofluorimetria, Ospedale dell'Angelo, Mestre-Venezia, Italy.""}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Cutini', 'Affiliation': 'Struttura Organizzativa Dipartimentale (SOD) Ematologia, Università di Firenze, and.'}, {'ForeName': 'Maria Ida', 'Initials': 'MI', 'LastName': 'Bonetti', 'Affiliation': 'Struttura Organizzativa Dipartimentale (SOD) Ematologia, Università di Firenze, and.'}, {'ForeName': 'Arianna', 'Initials': 'A', 'LastName': 'Masciulli', 'Affiliation': 'Unità Strutturale Complessa di Ematologia, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Ernesta', 'Initials': 'E', 'LastName': 'Audisio', 'Affiliation': 'Struttura Complessa di Ematologia, Ospedale Molinette, Turin, Italy.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Ferrero', 'Affiliation': 'Divisione di Ematologia, Università di Torino, Azienda Ospedaliera S. Giovanni Battista, Turin, Italy; and.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Pavoni', 'Affiliation': 'Unità Strutturale Complessa di Ematologia, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Scattolin', 'Affiliation': ""Unità Operativa di Ematologia, Ospedale dell'Angelo, Mestre-Venezia, Italy.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Bosi', 'Affiliation': 'Struttura Organizzativa Dipartimentale (SOD) Ematologia, Università di Firenze, and.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Rambaldi', 'Affiliation': 'Unità Strutturale Complessa di Ematologia, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Bassan', 'Affiliation': ""Unità Operativa di Ematologia, Ospedale dell'Angelo, Mestre-Venezia, Italy.""}]",Blood advances,['10.1182/bloodadvances.2019000406'] 4255,32160827,Successful recruitment of a multi-site international randomized placebo-controlled trial in people with HIV with attention to diversity of race and ethnicity: critical role of central coordination.,"Background: The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) is a multicenter, randomized, placebo-controlled trial, designed to test whether a statin medication can prevent cardiovascular disease in people with HIV. REPRIEVE recently completed enrollment of 7557 participants at over 100 clinical sites globally. Participant groups of focus were women, and racial and ethnic minorities. Objective: To describe recruitment methods and strategies developed by the REPRIEVE Clinical Coordinating Center (CCC) and share best practices learned from the recruitment process. Methods: Enrollment targets were agreed upon with the primary funder, the National Heart, Lung, and Blood Institute (NHLBI) and were milestone driven. Milestones included number of sites activated, number of participants enrolled within specific time frames, and proportion of women and minorities enrolled. Strategies to achieve these milestones included structured interviews with site-designated REPRIEVE Recruitment Champions to develop best practices, development of a multimedia campaign, and site level recruitment support. Results: Recruitment initiated March, 2015 and completed March, 2019. The final accrual target was 7500 participants over 48 months. The trial met this target within the time specified. Overall, 10,613 screens were completed, 48% of participants enrolled from sites outside of North America, 32% were female, 44% were Black or African American, and 25% were Hispanic or Latino. Conclusions: REPRIEVE met its overall projected recruitment goal by using multiple, simultaneous strategies to specifically target a diverse population including minority subgroups. REPRIEVE benefited from the development of recruitment strategies with clear targets and communication of accrual targets to study teams.",2020,"The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) is a multicenter, randomized, placebo-controlled trial, designed to test whether a statin medication can prevent cardiovascular disease in people with HIV.","['people with HIV with attention to diversity of race and ethnicity', '7557 participants at over 100 clinical sites globally', 'people with HIV', '10,613 screens were completed, 48% of participants enrolled from sites outside of North America, 32% were female, 44% were Black or African American, and 25% were Hispanic or Latino', '7500 participants over 48\u2009months', 'Participant groups of focus were women, and racial and ethnic minorities']","['statin medication', 'placebo']","['cardiovascular disease', 'number of sites activated, number of participants enrolled within specific time frames, and proportion of women and minorities enrolled']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C4517869', 'cui_str': 'Seven thousand five hundred'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0445108', 'cui_str': 'Number of sites (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0332168', 'cui_str': 'Time frame'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",10613.0,0.546729,"The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) is a multicenter, randomized, placebo-controlled trial, designed to test whether a statin medication can prevent cardiovascular disease in people with HIV.","[{'ForeName': 'Kathleen V', 'Initials': 'KV', 'LastName': 'Fitch', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Emma M', 'Initials': 'EM', 'LastName': 'Kileel', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Sara E', 'Initials': 'SE', 'LastName': 'Looby', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Markella V', 'Initials': 'MV', 'LastName': 'Zanni', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Laura R', 'Initials': 'LR', 'LastName': 'Sanchez', 'Affiliation': 'Division of Infectious Diseases, Ohio State University Wexner Medical Center, Columbus, OH, USA.'}, {'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Fichtenbaum', 'Affiliation': 'Division of Infectious Diseases, University of Cincinnati College of Medicine, Cincinnati, OH, USA.'}, {'ForeName': 'Edgar T', 'Initials': 'ET', 'LastName': 'Overton', 'Affiliation': 'Division of Infectious Diseases, University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Malvestutto', 'Affiliation': 'Division of Infectious Diseases, Ohio State University Wexner Medical Center, Columbus, OH, USA.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Aberg', 'Affiliation': 'Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Karin L', 'Initials': 'KL', 'LastName': 'Klingman', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Alston-Smith', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Lavelle', 'Affiliation': 'Office of the Director, NIAID, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Rancourt', 'Affiliation': 'Office of the Director, NIAID, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Sharlaa', 'Initials': 'S', 'LastName': 'Badal-Faesen', 'Affiliation': 'Clinical HIV Research Unit, Department of Internal Medicine, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Sandra Wagner', 'Initials': 'SW', 'LastName': 'Cardoso', 'Affiliation': 'Fundação Oswaldo Cruz, Instituto Nacional de Infectologia Evandro Chagas (INI/Fiocruz), Rio de Janeiro, Brazil.'}, {'ForeName': 'Anchalee', 'Initials': 'A', 'LastName': 'Avihingsanon', 'Affiliation': 'HIV-NAT, Thai Red Cross AIDS Research Centre; and Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Sandesh', 'Initials': 'S', 'LastName': 'Patil', 'Affiliation': 'Byramjee Jeejeebhoy Medical College, Johns Hopkins University Clinical Research Site, Pune, India.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Sponseller', 'Affiliation': 'Kowa Pharmaceuticals America, Inc, Montgomery, AL, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Melbourne', 'Affiliation': 'Gilead Sciences, Inc, Foster City, CA, USA.'}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Ribaudo', 'Affiliation': 'Center for Biostatistics in AIDS Research, Department of Biostatistics, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Cooper-Arnold', 'Affiliation': 'National Heart, Lung, and Blood Institute, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'National Heart, Lung, and Blood Institute, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Hoffmann', 'Affiliation': 'Cardiac MR PET CT Program and Department of Radiology, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",HIV research & clinical practice,['10.1080/25787489.2020.1733794'] 4256,31525441,"A regimen to minimize pain during blue light photodynamic therapy of actinic keratoses: Bilaterally controlled, randomized trial of simultaneous versus conventional illumination.","BACKGROUND Blue light photodynamic therapy (PDT) is effective for actinic keratosis, but many patients experience stinging pain during illumination. OBJECTIVE To compare a conventional regimen (1 hour of 5-aminolevulinic acid [ALA] preincubation, followed by blue light) versus a new modified regimen in which blue light is started immediately after ALA application. METHODS A clinical trial with a bilaterally controlled, intrapatient study design was conducted with 23 patients. Topical 20% ALA was applied to the entire face and/or scalp. On 1 side of the body, blue light was started immediately and continued for either 30, 45, or 60 minutes (simultaneous PDT). On the contralateral side, the blue light began 1 hour after ALA application and lasted 1000 seconds (conventional PDT). Pain was evaluated on a scale from 0 to 10. Actinic keratosis lesion counts were determined by clinical examination and photography. RESULTS All patients experienced significantly less pain during simultaneous illumination than during the conventional regimen. At 3 months after treatment, lesion clearance was nearly identical on the 2 sides, as determined by statistical testing of noninferiority ± 15% margin. LIMITATIONS Although bilaterally controlled, the study was relatively small. Additional studies are recommended. CONCLUSION The modified PDT regimen is essentially painless, yet it provides treatment efficacy similar to a conventional regimen.",2020,"At 3 months post-treatment, lesion clearance was nearly identical on the two sides, as determined by statistical testing of non-inferiority ± 15% margin. ","['23 patients', 'actinic keratoses']","['conventional regimen (1 h ALA preincubation, followed by blue light', 'Blue light photodynamic therapy (PDT', 'Topical 20% ALA', 'conventional illumination']","['lesion clearance', 'Pain', 'pain', 'AK lesion counts']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022602', 'cui_str': 'Senile keratoma (disorder)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0303896', 'cui_str': 'Blue light (physical force)'}, {'cui': 'C0031740', 'cui_str': 'Photodynamic Therapy'}, {'cui': 'C0044588', 'cui_str': 'PDT'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C1964256', 'cui_str': 'Illumination - action'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}]",1000.0,0.0120254,"At 3 months post-treatment, lesion clearance was nearly identical on the two sides, as determined by statistical testing of non-inferiority ± 15% margin. ","[{'ForeName': 'Urvashi', 'Initials': 'U', 'LastName': 'Kaw', 'Affiliation': 'Department of Dermatology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Muneeb', 'Initials': 'M', 'LastName': 'Ilyas', 'Affiliation': 'Department of Dermatology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Bullock', 'Affiliation': 'Department of Dermatology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Rittwage', 'Affiliation': 'Department of Dermatology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Margo', 'Initials': 'M', 'LastName': 'Riha', 'Affiliation': 'Department of Dermatology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Vidimos', 'Affiliation': 'Department of Dermatology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Hu', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Christine B', 'Initials': 'CB', 'LastName': 'Warren', 'Affiliation': 'Department of Dermatology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Maytin', 'Affiliation': 'Department of Dermatology, Cleveland Clinic, Cleveland, Ohio. Electronic address: maytine@ccf.org.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.09.010'] 4257,32060679,Efficacy of wheat hot pack (dry heat) and pottery hot pack (moist heat) on eyelid temperature and tissue blood flow in healthy eyes: a randomized control trial.,"PURPOSE To investigate the eyelid temperature (Temp) and tissue blood flow (TBF) changes in healthy eyes using wheat hot pack (WHP) and pottery hot pack (PHP). METHODS A randomized, double-blind, within-subject crossover study design was conducted in a Thai tertiary care center. All healthy subjects received warm compress treatment with WHP and PHP. The subjects were randomized to receive the WHP or the PHP at the first sequence. Temp and TBF measurements were taken at baseline, and every 2 min during the 10-min application of the heated compresses, and every 2 min for a 10-min duration after the compresses were removed. RESULTS There were 29 females (96.7%) and 1 male. The mean (SD) age of the subjects was 33.17 (5.21) years. Two warm compresses were able to increase the surface lid Temp significantly from the baseline Temp at every time point of measurement and location. For the WHP application, the maximum surface Temp (SD) of the outer upper lid, outer lower lid, and inner lower lid were 40.07 (0.80) °C, 38.44 (0.91) °C, and 35.83 (0.71) °C, respectively (all P value < 0.001) and under the PHP application, the highest surface Temp (SD) were 40.63 (0.97) °C, 38.32 (1.27) °C, and 35.82 (0.71) °C, respectively (all P value < 0.001). Both WHP and PHP were able to increase TBF significantly with no adverse events and these effects can be sustained until 20 min. CONCLUSIONS The results of this study suggest the potential of using these warm compresses for meibomian gland dysfunction. Further clinical research is needed.",2020,"Both WHP and PHP were able to increase TBF significantly with no adverse events and these effects can be sustained until 20 min. ","['All healthy subjects received', 'Thai tertiary care center', '29 females (96.7%) and 1 male', 'healthy eyes', 'healthy eyes using']","['warm compress treatment with WHP and PHP', 'wheat hot pack (dry heat) and pottery hot pack (moist heat', 'WHP', 'wheat hot pack (WHP) and pottery hot pack (PHP']","['eyelid temperature and tissue blood flow', 'surface lid Temp', 'TBF', 'Temp and TBF measurements', 'eyelid temperature (Temp) and tissue blood flow (TBF) changes']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0337910', 'cui_str': 'Thai'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0332260', 'cui_str': 'Compressing (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0444519', 'cui_str': 'Hot sensation quality (qualifier value)'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0205381', 'cui_str': 'Wet (qualifier value)'}]","[{'cui': 'C0015426', 'cui_str': 'Eyelids'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",29.0,0.0334943,"Both WHP and PHP were able to increase TBF significantly with no adverse events and these effects can be sustained until 20 min. ","[{'ForeName': 'Thidarat', 'Initials': 'T', 'LastName': 'Leeungurasatien', 'Affiliation': 'Glaucoma Division, Department of Ophthalmology, Faculty of Medicine, Chiang Mai University, 110 Intavarorot Road, Tambon Sripoom, Amphur Muang, Chiang Mai, 50200, Thailand. tleeungu@gmail.com.'}, {'ForeName': 'Aatit', 'Initials': 'A', 'LastName': 'Paungmali', 'Affiliation': 'Neuro-Musculoskeletal Pain and Research Unit, Department of Physical Therapy, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Apichat', 'Initials': 'A', 'LastName': 'Tantraworasin', 'Affiliation': 'General Thoracic Surgery Division, Department of Surgery, and Clinical Epidemiology and Clinical Statistic Center, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}]",International ophthalmology,['10.1007/s10792-020-01300-z'] 4258,32047963,The efficacy of immersive virtual reality surgical simulator training for pedicle screw placement: a randomized double-blind controlled trial.,"OBJECTIVE To verify whether the pedicle screw placement (PSP) skills of young surgeons receiving immersive virtual reality surgical simulator (IVRSS) training could be improved effectively and whether the IVRSS-PSP training mode could produce a real clinical value in clinical surgery. METHODS Twenty-four young surgeons were equally randomized to a VR group and a NON-VR group. Participants in VR group received IVRSS-PSP training, and those in NON-VR group used the conventional model of observing a spinal model first and then watching a teaching video of spinal surgery for 40 minutes x five. The nailing outcome of the participants before and after training was evaluated by statistical analysis in both groups. RESULTS Post-training data analysis showed that the success rate and accuracy rate of screw placement in VR group and NON-VR group were 82.9% and 69.6% vs. 74.2% and 55.4%, respectively, showing statistically significant differences between the two groups by chi-square test (P < 0.05). CONCLUSION The present study demonstrated that IVRSS-PSP was helpful to improve the success rate of PSP for young surgeons, and may provide valuable reference for PSP training of young surgeons. In addition, our study also showed a promising potential of the VR technology in surgical simulation training.",2020,"RESULTS Post-training data analysis showed that the success rate and accuracy rate of screw placement in VR group and NON-VR group were 82.9% and 69.6% vs. 74.2% and 55.4%, respectively, showing statistically significant differences between the two groups by chi-square test (P < 0.05). ","['Twenty-four young surgeons', 'pedicle screw placement', 'young surgeons receiving']","['pedicle screw placement (PSP', 'IVRSS-PSP', 'IVRSS-PSP training', 'immersive virtual reality surgical simulator (IVRSS) training', 'VR group and a NON-VR group', 'immersive virtual reality surgical simulator training']","['nailing outcome', 'success rate of PSP', 'success rate and accuracy rate of screw placement']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]","[{'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1868193', 'cui_str': 'PSP'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C1868193', 'cui_str': 'PSP'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]",24.0,0.0340094,"RESULTS Post-training data analysis showed that the success rate and accuracy rate of screw placement in VR group and NON-VR group were 82.9% and 69.6% vs. 74.2% and 55.4%, respectively, showing statistically significant differences between the two groups by chi-square test (P < 0.05). ","[{'ForeName': 'Baoquan', 'Initials': 'B', 'LastName': 'Xin', 'Affiliation': 'Shandong First Medical University & Shandong Academy of Medical Sciences, Taian, Shandong province, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Orthopaedic Oncology Center, Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wan', 'Affiliation': 'Orthopaedic Oncology Center, Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Lv', 'Affiliation': 'Anhui university of Chinese Medicine, 103 Meishan road, Shushan district, Anhui province, China.'}, {'ForeName': 'Yiwei', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Orthopaedic Oncology Center, Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Orthopaedic Oncology Center, Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, China.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Orthopaedic Oncology Center, Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Zou', 'Affiliation': 'Medical Imaging Department, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, China. czyyzww@163.com.'}, {'ForeName': 'Jianru', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': 'Orthopaedic Oncology Center, Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, China. jianruxiao83@163.com.'}, {'ForeName': 'Tielong', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Orthopaedic Oncology Center, Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, China. czyygzl@163.com.'}]",International orthopaedics,['10.1007/s00264-020-04488-y'] 4259,31494058,Access With Education Improves Fruit and Vegetable Intake in Preschool Children.,"OBJECTIVE To compare effects of interventions aimed at increasing fruit and vegetable (FV) intake in children. DESIGN Pre-post comparison and intervention study with randomly grouped classrooms. SETTING Head Start classrooms. PARTICIPANTS Two hundred nine Head Start children. INTERVENTIONS Treatment A (n = 61) and treatment B (n = 82) children received high-carotenoid FVs for 8 weeks. Treatment B children also received weekly FV education, and their caregivers received FV information and recipes. The comparison group (n = 66) received neither FVs nor education. MAIN OUTCOME MEASURE Carotenoid values in Raman units. ANALYSIS Multilevel mixed models, ANCOVA, and post hoc analysis were used. RESULTS Multilevel mixed models with the group as fixed effect and classrooms within group as a random effect; ANCOVA showed that the only significant variable affecting the score was the group main effect. The intraclass correlation coefficient was 0.037; the Raman unit scores of treatment B were significantly higher than those of treatment A (P = .02) or comparison group (P < .001). However, there was no significant difference between treatment A and comparison (P = .10; Cohen D = .71). CONCLUSIONS AND IMPLICATIONS The results suggested that providing education where FVs are offered may help increase consumption. Measurement of carotenoids in family members who received FVs plus education, as well as replication of this model in different locations and ages of children should be investigated in future research.",2020,"However, there was no significant difference between treatment A and comparison (P = .10; Cohen D = .71). ","['children', 'Two hundred nine Head Start children', 'Head Start classrooms', 'Preschool Children']","['high-carotenoid FVs', 'Education Improves Fruit and Vegetable Intake', 'FVs nor education']","['Carotenoid values in Raman units', 'fruit and vegetable (FV) intake']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0007271', 'cui_str': 'Carotenes and Carotenoids'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}]","[{'cui': 'C0007271', 'cui_str': 'Carotenes and Carotenoids'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}]",209.0,0.0395194,"However, there was no significant difference between treatment A and comparison (P = .10; Cohen D = .71). ","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Smith', 'Affiliation': 'Department of Human Sciences, College of Behavioral and Health Sciences, Middle Tennessee State University, Murfreesboro, TN. Electronic address: Elizabeth.Ann.Smith@mtsu.edu.'}, {'ForeName': 'Toto', 'Initials': 'T', 'LastName': 'Sutarso', 'Affiliation': 'Information Technology Division, Middle Tennessee State University, Murfreesboro, TN.'}, {'ForeName': 'Gail L', 'Initials': 'GL', 'LastName': 'Kaye', 'Affiliation': 'Division of Health Behavior and Health Promotion, College of Public Health, Ohio State University, Columbus, OH.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2019.07.016'] 4260,32087610,Pilot randomized controlled trial of a video self-help intervention for depression based on acceptance and commitment therapy: Feasibility and acceptability.,"A common setting where depression is identified and treated is in primary care, where there is a need for low-intensity and cost-effective interventions to be used as part of a stepped-care model. The current study involved a pilot, parallel-group, randomized controlled trial of a video self-help intervention for primary care patients based on acceptance and commitment therapy (ACT). The intervention, called LifeStories, consisted of storytelling vignettes of patients describing their use of ACT-consistent coping skills for depression. Primary care patients were recruited to determine feasibility, acceptability, and potential clinical effects of the intervention. Twenty-one participants were assigned to use LifeStories over a period of 4 weeks, and 19 participants were assigned to an attention-matched comparison group. Qualitative feedback indicated that participants using LifeStories found the intervention to be engaging and useful in transmitting key ACT principles. Furthermore, those receiving LifeStories rated their level of ""transportation"" or immersion in the videos higher than the control group. Both conditions showed large improvements in levels of depression at a 12-week follow-up. There were no significant differences in symptom outcomes between groups; however, because this was a pilot study, it was not powered to detect differences between interventions. Both conditions additionally showed smaller effect size changes in psychological flexibility, a key ACT mechanism. The results suggest LifeStories to be a feasible and acceptable psychological intervention that may improve depression, and further research is warranted to determine its effectiveness as part of a stepped-care approach to treating depression in primary care.",2020,"Furthermore, those receiving LifeStories rated their level of ""transportation"" or immersion in the videos higher than the control group.","['A total of 21 participants', 'Primary care patients', 'primary care patients based on Acceptance and Commitment Therapy (ACT']","['ACT-consistent coping skills', 'Video Self-Help Intervention', 'video self-help intervention']","['symptom outcomes', 'psychological flexibility', 'levels of depression']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}]",21.0,0.0716519,"Furthermore, those receiving LifeStories rated their level of ""transportation"" or immersion in the videos higher than the control group.","[{'ForeName': 'Brandon A', 'Initials': 'BA', 'LastName': 'Gaudiano', 'Affiliation': 'Psychosocial Research Program, Butler Hospital, Providence, Rhode Island.'}, {'ForeName': 'Carter H', 'Initials': 'CH', 'LastName': 'Davis', 'Affiliation': 'Department of Psychology, Utah State University, Logan, Utah.'}, {'ForeName': 'Ivan W', 'Initials': 'IW', 'LastName': 'Miller', 'Affiliation': 'Psychosocial Research Program, Butler Hospital, Providence, Rhode Island.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Uebelacker', 'Affiliation': 'Psychosocial Research Program, Butler Hospital, Providence, Rhode Island.'}]",Clinical psychology & psychotherapy,['10.1002/cpp.2436'] 4261,31767470,Dose-volume predictors of early esophageal toxicity in non-small cell lung cancer patients treated with accelerated-hyperfractionated radiotherapy.,"BACKGROUND AND PURPOSE Early radiation-induced esophageal toxicity (RIET) is one of the major side effects in patients with non-small cell lung cancer (NSCLC) and can be a reason for treatment interruptions. As the age of patients with NSCLC and corresponding comorbidities continue to increase, primary radiotherapy alone is a commonly used alternative treatment in these cases. The aim of the present study is to compare dosimetric and clinical parameters from the previously reported CHARTWEL trial for their ability to predict esophagitis and investigate potential differences in the accelerated and conventional fractionation arm. MATERIAL AND METHODS 146 patients of the Dresden cohort of the randomized phase III CHARTWEL trial were included in this post-hoc analysis. Side effects were prospectively scored weekly during the first 8 weeks from start of radiotherapy. To compare both treatment arms, recorded dose-volume parameters were adjusted for the different fractionation schedules. Logistic regression was performed to predict early RIET for the entire study group as well as for the individual treatment arms. Different dosimetric and clinical parameters were tested. RESULTS Patients receiving the accelerated CHARTWEL schedule experienced earlier and more severe esophagitis (e.g. 20.5% vs. 9.6% ≥grade 2 at week 3, respectively). In contrast, the median time period for recovery of grade 1 esophagitis was significantly longer for patients with conventional fractionation compared to the CHARTWEL group (median [range]: 21 [12-49] days vs. 15 [7-84] days, p = 0.028). In univariable logistic regression none of the dose-volume parameters showed a significant correlation with early RIET grade ≥ 2 in the conventional irradiation group. In contrast, for patients receiving CHARTWEL, the physical dose-volumes parameters V 40 and V 50 ; and re-scaled values V EQD2,50 and V EQD2,60 were significant predictors of early RIET grade ≥ 2. Dose-volume parameters remained different between CHARTWEL and conventional fractionation even after biological rescaling. CONCLUSION Our results show a more dominant dose-volume effect in the CHARTWEL arm compared to conventional fractionation, especially for higher esophageal doses. These findings support the notion that dose-volume parameters for radiation esophagitis determined in a specific and time dependent setting of field arrangements can not be easily transferred to another setting. In clinical practice esophageal volumes receiving 40 Gy or more should be strictly limited in hyperfractionated-accelerated fraction schemes.",2020,In univariable logistic regression none of the dose-volume parameters showed a significant correlation with early RIET grade ≥ 2 in the conventional irradiation group.,"['patients with non-small cell lung cancer (NSCLC', 'non-small cell lung cancer patients treated with', '146 patients of the Dresden cohort of the randomized phase III']",['accelerated-hyperfractionated radiotherapy'],"['Side effects', 'early esophageal toxicity', 'median time period for recovery of grade 1 esophagitis', 'severe esophagitis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1948053', 'cui_str': 'Time periods (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0014868', 'cui_str': 'Esophagitis'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",146.0,0.0389048,In univariable logistic regression none of the dose-volume parameters showed a significant correlation with early RIET grade ≥ 2 in the conventional irradiation group.,"[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Bütof', 'Affiliation': 'OncoRay - National Center for Radiation Research in Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Helmholtz-Zentrum Dresden-Rossendorf, Germany; Department of Radiotherapy and Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Germany; National Center for Tumor Diseases (NCT), Partner Site Dresden, Germany: German Cancer Research Center (DKFZ), Heidelberg, Germany; Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany, and; Helmholtz Association / Helmholtz-Zentrum Dresden - Rossendorf (HZDR), Dresden, Germany. Electronic address: rebecca.buetof@uniklinikum-dresden.de.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Löck', 'Affiliation': 'OncoRay - National Center for Radiation Research in Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Helmholtz-Zentrum Dresden-Rossendorf, Germany; Department of Radiotherapy and Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Germany; German Cancer Consortium (DKTK), Partner Site Dresden, Germany.'}, {'ForeName': 'Maher', 'Initials': 'M', 'LastName': 'Soliman', 'Affiliation': 'Department of Radiotherapy and Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Germany; Oncology Department, Faculty of Medicine, Alexandria University, Egypt.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Haase', 'Affiliation': 'OncoRay - National Center for Radiation Research in Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Helmholtz-Zentrum Dresden-Rossendorf, Germany.'}, {'ForeName': 'Rosalind', 'Initials': 'R', 'LastName': 'Perrin', 'Affiliation': 'OncoRay - National Center for Radiation Research in Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Helmholtz-Zentrum Dresden-Rossendorf, Germany; Strahlenklinik, Universitätsklinikum Erlangen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Richter', 'Affiliation': 'OncoRay - National Center for Radiation Research in Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Helmholtz-Zentrum Dresden-Rossendorf, Germany; Department of Radiotherapy and Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Germany; German Cancer Consortium (DKTK), Partner Site Dresden, Germany; Helmholtz-Zentrum Dresden - Rossendorf, Institute of Radiooncology - OncoRay, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Appold', 'Affiliation': 'OncoRay - National Center for Radiation Research in Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Helmholtz-Zentrum Dresden-Rossendorf, Germany; Department of Radiotherapy and Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Germany; National Center for Tumor Diseases (NCT), Partner Site Dresden, Germany: German Cancer Research Center (DKFZ), Heidelberg, Germany; Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany, and; Helmholtz Association / Helmholtz-Zentrum Dresden - Rossendorf (HZDR), Dresden, Germany.'}, {'ForeName': 'Mechthild', 'Initials': 'M', 'LastName': 'Krause', 'Affiliation': 'OncoRay - National Center for Radiation Research in Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Helmholtz-Zentrum Dresden-Rossendorf, Germany; Department of Radiotherapy and Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Germany; National Center for Tumor Diseases (NCT), Partner Site Dresden, Germany: German Cancer Research Center (DKFZ), Heidelberg, Germany; Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany, and; Helmholtz Association / Helmholtz-Zentrum Dresden - Rossendorf (HZDR), Dresden, Germany; German Cancer Consortium (DKTK), Partner Site Dresden, Germany; Helmholtz-Zentrum Dresden - Rossendorf, Institute of Radiooncology - OncoRay, Germany; German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Baumann', 'Affiliation': 'OncoRay - National Center for Radiation Research in Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Helmholtz-Zentrum Dresden-Rossendorf, Germany; Department of Radiotherapy and Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Germany; German Cancer Consortium (DKTK), Partner Site Dresden, Germany; Helmholtz-Zentrum Dresden - Rossendorf, Institute of Radiooncology - OncoRay, Germany; German Cancer Research Center (DKFZ), Heidelberg, Germany.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2019.11.002'] 4262,30579673,Determinants and the Role of Self-Efficacy in a Sodium-Reduction Trial in Hemodialysis Patients.,"OBJECTIVE This study was to assess the impact of baseline dietary self-efficacy on the effect of a dietary intervention to reduce sodium intake in patients undergoing hemodialysis (HD) and to identify determinants of low dietary self-efficacy. METHODS This is a post hoc analysis of the BalanceWise study, a randomized controlled trial that aimed to reduce dietary sodium intake in HD patients recruited from 17 dialysis centers in Pennsylvania. The main outcome measures include dietary self-efficacy and reported dietary sodium density. Analysis of variance with post hoc group-wise comparison was used to examine the effect of baseline dietary self-efficacy on changes in reported sodium density in the intervention and control groups at 8 and 16 weeks. Chi-square test, independent t tests, or Wilcoxon rank-sum tests were used to identify determinants of low dietary self-efficacy. RESULTS The interaction between dietary self-efficacy and the impact of the intervention on changes in reported dietary sodium density approached significance at 8 and 16 weeks (P interaction = 0.051 and 0.06, respectively). Younger age and perceived income inadequacy were significantly associated with low self-efficacy in patients undergoing HD. CONCLUSION The benefits of dietary interventions designed to improve self-efficacy may differ by the baseline self-efficacy status. This may be particularly important for HD patients who are younger and report inadequate income as they had lower dietary self-efficacy.",2019,"The interaction between dietary self-efficacy and the impact of the intervention on changes in reported dietary sodium density approached significance at 8 and 16 weeks (P interaction = 0.051 and 0.06, respectively).","['patients undergoing hemodialysis (HD', 'HD patients who are younger and report inadequate income', 'HD patients recruited from 17 dialysis centers in Pennsylvania', 'Hemodialysis Patients']",['dietary intervention'],"['self-efficacy', 'dietary self-efficacy and reported dietary sodium density']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}]",[],"[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0037570', 'cui_str': 'Sodium, Dietary'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}]",,0.0354234,"The interaction between dietary self-efficacy and the impact of the intervention on changes in reported dietary sodium density approached significance at 8 and 16 weeks (P interaction = 0.051 and 0.06, respectively).","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': 'New York University School of Medicine, Center for Healthful Behavior Change, New York, New York. Electronic address: lu.hu@nyumc.org.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'St-Jules', 'Affiliation': 'New York University School of Medicine, Center for Healthful Behavior Change, New York, New York.'}, {'ForeName': 'Collin J', 'Initials': 'CJ', 'LastName': 'Popp', 'Affiliation': 'New York University School of Medicine, Center for Healthful Behavior Change, New York, New York.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': 'Sevick', 'Affiliation': 'New York University School of Medicine, Center for Healthful Behavior Change, New York, New York.'}]",Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation,['10.1053/j.jrn.2018.10.006'] 4263,31512101,A Prospective Randomized Trial Comparing Jejunostomy and Nasogastric Feeding in Minimally Invasive McKeown Esophagectomy.,"BACKGROUND Early postoperative enteral nutrition is recommended for patients undergoing esophagectomy; however, the optimum method of tube feeding remains controversial. Thus, the aim of this study is to assess two common enteral nutrition methods after minimally invasive McKeown esophagectomy. METHODS A randomized controlled trial was performed with 120 patients who underwent minimally invasive McKeown esophagectomy from January 2017 to December 2018. The patients were randomly divided so that 58 patients were in the jejunostomy feeding (JF) group and 62 patients were in the nasogastric feeding (NF) group. The postoperative outcomes, including complications, nutritional status, quality of life, and survival rate, were studied and used as the main parameters to compare the abovementioned tube feeding methods. RESULTS The incidence of overall complications was equivalent between the two groups (P = 0.625), except for bowel obstruction (which occurred 4 times in the JF group but did not occur in the NF group). In the first month after surgery (postoperative month 1, POM1), a significantly higher body mass index (BMI) was observed in the JF group (23.6 ± 3.2) than in the NF group (20.9 ± 3.5, P = 0.032). The global quality-of-life scores were better in the JF group than in the NF group (P < 0.001). In addition, there were no significant differences between the two groups in terms of disease-free survival (DFS) (P = 0.816) and overall survival (OS) (P = 0.564). CONCLUSIONS Compared with NF, JF provides more safety, efficacy, and utility as nutritional support for minimally invasive McKeown esophagectomy patients who have a high incidence of anastomotic leakage. However, the higher risk of intestinal obstruction after JF requires attention.",2020,"The incidence of overall complications was equivalent between the two groups (P = 0.625), except for bowel obstruction (which occurred 4 times in the JF group but did not occur in the NF group).","['120 patients who underwent', 'minimally invasive McKeown esophagectomy patients who have a high incidence of anastomotic leakage', 'from January 2017 to December 2018', 'Minimally Invasive McKeown Esophagectomy', 'patients undergoing esophagectomy']","['nasogastric feeding (NF', 'jejunostomy feeding (JF', 'NF, JF', 'Jejunostomy and Nasogastric Feeding', 'minimally invasive McKeown esophagectomy']","['disease-free survival (DFS', 'incidence of overall complications', 'postoperative outcomes, including complications, nutritional status, quality of life, and survival rate', 'overall survival (OS', 'body mass index (BMI', 'global quality-of-life scores', 'bowel obstruction']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0472888', 'cui_str': 'McKeown esophagectomy (procedure)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic Leakage'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}]","[{'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0192715', 'cui_str': 'Jejunostomy feeding (regime/therapy)'}, {'cui': 'C0022377', 'cui_str': 'Jejunostomy'}, {'cui': 'C0192456', 'cui_str': 'Nasogastric tube feeding'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0472888', 'cui_str': 'McKeown esophagectomy (procedure)'}]","[{'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0034380'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0021843', 'cui_str': 'Intestinal Obstruction'}]",,0.0333319,"The incidence of overall complications was equivalent between the two groups (P = 0.625), except for bowel obstruction (which occurred 4 times in the JF group but did not occur in the NF group).","[{'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Tao', 'Affiliation': 'Department of Thoracic Surgery, The First Affiliated Hospital of Wannan Medical College, Wuhu, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic Surgery, The First Affiliated Hospital of Wannan Medical College, Wuhu, China.'}, {'ForeName': 'Shaojin', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': 'Department of Thoracic Surgery, The First Affiliated Hospital of Wannan Medical College, Wuhu, China.'}, {'ForeName': 'Zhengzheng', 'Initials': 'Z', 'LastName': 'Ni', 'Affiliation': 'Department of Thoracic Surgery, The First Affiliated Hospital of Wannan Medical College, Wuhu, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'You', 'Affiliation': 'Department of Thoracic Surgery, The First Affiliated Hospital of Wannan Medical College, Wuhu, China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Thoracic Surgery, The First Affiliated Hospital of Wannan Medical College, Wuhu, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': 'Department of Thoracic Surgery, The First Affiliated Hospital of Wannan Medical College, Wuhu, China. dongxusuda@126.com.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-019-04390-y'] 4264,30273282,Cardiovascular Effects of Compression Garments During Uncompensable Heat Stress.,"ABSTRACT Bautz, J, Hostler, D, Khorana, P, and Suyama, J. Cardiovascular effects of compression garments during uncompensable heat stress. J Strength Cond Res 35(4): 1058-1065, 2021-This study examined the potential hemodynamic benefits of wearing lower extremity compression garments (CGs) beneath thermal protective clothing (TPC) worn by wildland firefighters, while exercising in a heated environment. Using in a counterbalanced design, 10 male subjects ([mean ± SD] age 27 ± 6 years, height 1.78 ± 0.09 m, body mass 74.8 ± 7.0 kg, body fat 10.6 ± 4.2%, and V̇o2max 57.8 ± 9.3 ml·kg-1·min-1) completed control (no CG) and experimental (CG) conditions in randomly assigned order. Protocols were separated by a minimum of 3 days. Subjects exercised for 90 minutes (three, 30-minute segments) on a treadmill while wearing wilderness firefighter TPC and helmet in a heated room. Venous blood was drawn before and after exercise to measure hemoglobin (Hgb), hematocrit (Hct), serum osmolarity (OSM), and serum creatine phosphokinase (CPK). Vital signs and perceptual measures of exertion and thermal comfort were recorded during the protocol. Data were analyzed by the paired t-test. There were no differences in the change in heart rate (84 ± 27 vs. 85 ± 14 b·min-1, p = 0.9), core temperature rise (1.8 ± 0.6 vs. 1.9 ± 0.5° C, p = 0.39), or body mass lost (-1.72 ± 0.78 vs. -1.77 ± 0.58 kg, p = 0.7) between the conditions. There were no differences in the change in Hgb (0.49 ± 0.66 vs. 0.33 ± 1.11 g·dl-1, p = 0.7), Hct (1.22 ± 1.92 vs. 1.11 ± 3.62%, p = 0.9), OSM (1.67 ± 6.34 vs. 6.22 ± 11.39 mOsm·kg-1, p = 0.3), or CPK (22.2 ± 30.2 vs. 29.8 ± 19.4 IU·L-1, p = 0.5). Total distance walked (3.9 ± 0.5 vs. 4.0 ± 0.5 miles, p = 0.2), exercise interval (88.6 ± 3.5 vs. 88.4 ± 3.6 minutes, p = 0.8), and perceptual measures were similar between conditions. Compression garments worn beneath TPC did not acutely alter the physiologic response to exertion in TPC. With greater use in the general public related to endurance activities, the data neither encourage nor discourage CG use during uncompensable heat stress.",2021,"There were no differences in the change in Hgb (0.49 ± 0.66 vs. 0.33 ± 1.11 g·dl, p = 0.7), Hct (1.22 ± 1.92 vs. 1.11 ± 3.62%, p = 0.9), OSM (1.67 ± 6.34 vs. 6.22 ± 11.39 mOsm·kg, p = 0.3), or CPK (22.2 ± 30.2 vs. 29.8 ± 19.4 IU·L, p = 0.5).","[' 000-000', '10 male subjects ([mean ± SD] age 27 ± 6 years, height 1.78 ± 0.09 m, body mass 74.8 ± 7.0 kg, body fat 10.6 ± 4.2%, and V[Combining Dot Above]O2max 57.8 ± 9.3 ml·kg·min']","['J Strength Cond Res XX(X', 'treadmill while wearing wilderness firefighter TPC and helmet in a heated room', 'Compression Garments', 'wearing lower extremity compression garments (CGs) beneath thermal protective clothing (TPC']","['heart rate', 'hemoglobin (Hgb), hematocrit (Hct), serum osmolarity (OSM), and serum creatine phosphokinase (CPK', 'core temperature rise', 'perceptual measures', 'Bautz, J, Hostler, D, Khorana, P, and Suyama, J. Cardiovascular effects', 'Vital signs and perceptual measures of exertion and thermal comfort', 'exercise interval']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517419', 'cui_str': 'Zero point zero nine'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C4517758', 'cui_str': 'Four point two'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C2350577', 'cui_str': 'Wilderness'}, {'cui': 'C0221459', 'cui_str': 'Fire and Rescue Personnel'}, {'cui': 'C0018884', 'cui_str': 'Helmets'}, {'cui': 'C2985539', 'cui_str': 'Compression garment (physical object)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0033611', 'cui_str': 'Protective Clothing'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0029387', 'cui_str': 'Osmolarity'}, {'cui': 'C0750860', 'cui_str': 'Serum creatine phosphokinase'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0518766'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",10.0,0.0265512,"There were no differences in the change in Hgb (0.49 ± 0.66 vs. 0.33 ± 1.11 g·dl, p = 0.7), Hct (1.22 ± 1.92 vs. 1.11 ± 3.62%, p = 0.9), OSM (1.67 ± 6.34 vs. 6.22 ± 11.39 mOsm·kg, p = 0.3), or CPK (22.2 ± 30.2 vs. 29.8 ± 19.4 IU·L, p = 0.5).","[{'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Bautz', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; and.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hostler', 'Affiliation': 'Center for Research and Education in Special Environments, Exercise and Nutrition Sciences, SUNY University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Khorana', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; and.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Suyama', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; and.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002852'] 4265,30761976,The CORE service improvement programme for mental health crisis resolution teams: results from a cluster-randomised trial.,"BACKGROUND Crisis resolution teams (CRTs) offer brief, intensive home treatment for people experiencing mental health crisis. CRT implementation is highly variable; positive trial outcomes have not been reproduced in scaled-up CRT care. AIMS To evaluate a 1-year programme to improve CRTs' model fidelity in a non-masked, cluster-randomised trial (part of the Crisis team Optimisation and RElapse prevention (CORE) research programme, trial registration number: ISRCTN47185233). METHOD Fifteen CRTs in England received an intervention, informed by the US Implementing Evidence-Based Practice project, involving support from a CRT facilitator, online implementation resources and regular team fidelity reviews. Ten control CRTs received no additional support. The primary outcome was patient satisfaction, measured by the Client Satisfaction Questionnaire (CSQ-8), completed by 15 patients per team at CRT discharge (n = 375). Secondary outcomes: CRT model fidelity, continuity of care, staff well-being, in-patient admissions and bed use and CRT readmissions were also evaluated. RESULTS All CRTs were retained in the trial. Median follow-up CSQ-8 score was 28 in each group: the adjusted average in the intervention group was higher than in the control group by 0.97 (95% CI -1.02 to 2.97) but this was not significant (P = 0.34). There were fewer in-patient admissions, lower in-patient bed use and better staff psychological health in intervention teams. Model fidelity rose in most intervention teams and was significantly higher than in control teams at follow-up. There were no significant effects for other outcomes. CONCLUSIONS The CRT service improvement programme did not achieve its primary aim of improving patient satisfaction. It showed some promise in improving CRT model fidelity and reducing acute in-patient admissions.",2020,Model fidelity rose in most intervention teams and was significantly higher than in control teams at follow-up.,['people experiencing mental health crisis'],[],"['CRT model fidelity, continuity of care, staff well-being, in-patient admissions and bed use and CRT readmissions', 'Model fidelity', 'patient satisfaction, measured by the Client Satisfaction Questionnaire (CSQ-8', 'Median follow-up CSQ-8 score', 'CRT model fidelity', 'patient satisfaction', 'patient admissions, lower in-patient bed use and better staff psychological health']","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0231224', 'cui_str': 'Crisis (finding)'}]",[],"[{'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0009853', 'cui_str': 'Continuity of Care'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0030673', 'cui_str': 'Patient Admission'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",375.0,0.271692,Model fidelity rose in most intervention teams and was significantly higher than in control teams at follow-up.,"[{'ForeName': 'Brynmor', 'Initials': 'B', 'LastName': 'Lloyd-Evans', 'Affiliation': 'Senior Lecturer, Division of Psychiatry, University College London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Osborn', 'Affiliation': 'Professor of Psychiatric Epidemiology, Division of Psychiatry, University College London; and St Pancras Hospital, Camden and Islington NHS Foundation Trust, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Marston', 'Affiliation': 'Principal Research Associate, Department of Primary Care and Population Health, UCL Medical School (Royal Free Campus); and Priment Clinical Trials Unit, UK.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Lamb', 'Affiliation': 'Research Associate, Division of Psychiatry, University College London, UK.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Ambler', 'Affiliation': 'Associate Professor in Medical Statistics, Department of Statistical Science, UCL, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Hunter', 'Affiliation': 'Senior Research Associate, Department of Primary Care and Population Health, UCL Medical School (Royal Free Campus); and Priment Clinical Trials Unit, UK.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Mason', 'Affiliation': 'Reader in Clinical Psychology, School of Psychology, University of Surrey, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Sullivan', 'Affiliation': 'Research Fellow, Epidemiology and Health Services Research, CLAHRC West, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Henderson', 'Affiliation': 'Clinical Senior Lecturer, Institute of Psychiatry, Psychology and Neuroscience, Kings College London, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Onyett', 'Affiliation': 'previously Chief Executive, Onyett Entero, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Johnston', 'Affiliation': 'Principal Research Associate, Division of Psychiatry, University College London, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Morant', 'Affiliation': 'Associate Professor, Division of Psychiatry, University College London, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Nolan', 'Affiliation': 'Professor of Nursing, School of Health and Human Sciences, University of Essex, UK.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Kelly', 'Affiliation': 'Consultant Psychiatrist, Barnes Unit, John Radcliffe Hospital, Oxford Health NHS Foundation Trust, UK.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Christoforou', 'Affiliation': 'Research Assistant, Division of Psychiatry, University College London, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Fullarton', 'Affiliation': 'Research Assistant, Division of Psychiatry, University College London, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Forsyth', 'Affiliation': 'Research Assistant, Division of Psychiatry, University College London, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Davidson', 'Affiliation': 'Research Assistant, Division of Psychiatry, University College London, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Piotrowski', 'Affiliation': 'Research Assistant, Avon and Wiltshire Mental Health Partnership NHS Trust, Research & Development Office, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Mundy', 'Affiliation': 'Research Assistant, Division of Psychiatry, University College London, UK.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Bond', 'Affiliation': 'Professor of Psychiatry, Westat, Rivermill Commercial Center, UK.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Professor of Social and Community Psychiatry, Division of Psychiatry, University College London; and St Pancras Hospital, Camden and Islington NHS Foundation Trust, UK.'}]",The British journal of psychiatry : the journal of mental science,['10.1192/bjp.2019.21'] 4266,29671035,[Prognostic relevance of tissue oxygen saturation in patients in the early stage of multiple organ dysfunction syndrome].,"BACKGROUND Patients in circulatory shock exhibit insufficient peripheral perfusion to ensure adequate oxygenation of vital organs such as the heart and brain. Early detection of reduced tissue oxygen saturation (S t O 2 ) could be used for rapid therapeutic intervention and thus improve the prognosis of patients in the early stage of multiple organ dysfunction syndrome (MODS). MATERIALS AND METHODS A total of 60 patients in the early stage of MODS (APACHE [Acute Physiology and Chronic Health Evaluation] II score ≥20) were investigated in a monocentric, prospective, randomized phase II study. S t O 2 was measured using the InSpectraTM S t O 2 system and compared with known indicators of hypoxia (peripheral oxygen saturation [S p O 2 ], arterial oxygen saturation [S a O 2 ], central venous oxygen saturation [S cv O 2 ], pH, serum lactate). Clinical endpoints of the study were 28-day and 6‑month mortality as well as the need for invasive mechanical ventilation and renal replacement therapy during the hospital stay, respectively. RESULTS An increased 28-day and 6‑month mortality is found for patients with S t O 2 <75% in contrast to patients with S t O 2 ≥75%. Correlations of S t O 2 with S p O 2 , S cv O 2 , and serum lactate are confirmed. Patients with reduced S t O 2 tend to show a higher disease severity as measured by APACHE II score. CONCLUSION S t O 2 shows prognostic relevance in patients at the early stage of MODS. Thus, the rapid and noninvasive assessment of S t O 2 could be useful in risk stratification of these patients.",2019,An increased 28-day and 6‑month mortality is found for patients with S t O 2 <75% in contrast to patients with S t O 2 ≥75%.,"['60\xa0patients in the early stage of MODS (APACHE [Acute Physiology and Chronic Health Evaluation] II score ≥20', 'patients in the early stage of multiple organ dysfunction syndrome']",['tissue oxygen saturation'],"['hypoxia (peripheral oxygen saturation [S p O 2 ], arterial oxygen saturation [S a O 2 ], central venous oxygen saturation [S cv O 2 ], pH, serum lactate', '28-day and 6‑month mortality', 'cv O 2 , and serum lactate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0026766', 'cui_str': 'Organ Dysfunction Syndrome, Multiple'}, {'cui': 'C0243030', 'cui_str': 'Acute Physiology and Chronic Health Evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C2711000', 'cui_str': 'SaO2 - Arterial oxygen saturation'}, {'cui': 'C0444466', 'cui_str': 'Central venous (qualifier value)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0267222,An increased 28-day and 6‑month mortality is found for patients with S t O 2 <75% in contrast to patients with S t O 2 ≥75%.,"[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Huster', 'Affiliation': 'Universitätsklinik und Poliklinik für Innere Medizin\xa0III, Universitätsklinikum Halle (Saale), Halle, Deutschland.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Härtel', 'Affiliation': 'Universitätsklinik und Poliklinik für Innere Medizin\xa0III, Universitätsklinikum Halle (Saale), Halle, Deutschland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nuding', 'Affiliation': 'Universitätsklinik und Poliklinik für Innere Medizin\xa0III, Universitätsklinikum Halle (Saale), Halle, Deutschland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Schroeder', 'Affiliation': 'Universitätsklinik und Poliklinik für Innere Medizin\xa0III, Universitätsklinikum Halle (Saale), Halle, Deutschland.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Universitätsklinik und Poliklinik für Innere Medizin\xa0III, Universitätsklinikum Halle (Saale), Halle, Deutschland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Werdan', 'Affiliation': 'Universitätsklinik und Poliklinik für Innere Medizin\xa0III, Universitätsklinikum Halle (Saale), Halle, Deutschland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Ebelt', 'Affiliation': 'Universitätsklinik und Poliklinik für Innere Medizin\xa0III, Universitätsklinikum Halle (Saale), Halle, Deutschland. hebelt@kkh-erfurt.de.'}]","Medizinische Klinik, Intensivmedizin und Notfallmedizin",['10.1007/s00063-018-0438-6'] 4267,32115311,Aggression Prevention Training for Individuals With Dementia and Their Caregivers: A Randomized Controlled Trial.,"OBJECTIVE International appeals call for interventions to prevent aggression and other behavioral problems in individuals with dementia (IWD). Aggression Prevention Training (APT), based on intervening in three contributors to development of aggression (IWD pain, IWD depression, and caregiver-IWD relationship problems) aims to reduce incidence of aggression in IWD over 1 year. DESIGN Randomized, controlled trial. SETTING Three clinics that assess, diagnose, and treat dementia. PARTICIPANTS Two hundred twenty-eight caregiver-IWD dyads who screened positive for IWD pain, IWD depression, or caregiver-IWD relationship problems randomized to APT or Enhanced Usual Primary Care (EU-PC). INTERVENTION APT, a skills-based intervention delivered over 3 months to address pain/depression/caregiver-IWD relationship issues. EU-PC included printed material on dementia and community resources; and eight brief, weekly support calls. MEASUREMENTS The primary outcome was incidence of aggression over 1 year, determined by the Cohen Mansfield Agitation Inventory-Aggression Subscale. Secondary outcomes included pain, depression, caregiver-IWD relationship, caregiver burden, positive caregiving, behavior problems, and anxiety. RESULTS Aggression incidence and secondary outcomes did not differ between groups. However, in those screening positive for IWD depression or caregiver-IWD relationship problems, those receiving EU-PC had significant increases in depression and significant decreases in quality of the caregiver-IWD relationship, whereas those receiving APT showed no changes in these outcomes over time. CONCLUSION The cost to patients, family, and society of behavioral problems in IWD, along with modest efficacy of most pharmacologic and nonpharmacologic interventions, calls for more study of novel preventive approaches.",2020,"RESULTS Aggression incidence and secondary outcomes did not differ between groups.","['Two hundred twenty-eight caregiver-IWD dyads who screened positive for IWD pain, IWD depression, or caregiver-IWD relationship problems randomized to APT or Enhanced Usual Primary Care (EU-PC', 'Three clinics that assess, diagnose, and treat dementia', 'individuals with dementia (IWD', 'Individuals With Dementia and Their Caregivers']","['Aggression Prevention Training', 'Aggression Prevention Training (APT']","['incidence of aggression over 1 year, determined by the Cohen Mansfield Agitation Inventory-Aggression Subscale', 'IWD pain, IWD depression, and caregiver-IWD relationship problems', 'depression', 'quality of the caregiver-IWD relationship', 'pain, depression, caregiver-IWD relationship, caregiver burden, positive caregiving, behavior problems, and anxiety']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0425168', 'cui_str': 'Relationship problems (finding)'}, {'cui': 'C0003645', 'cui_str': 'APT'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0003645', 'cui_str': 'APT'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0425168', 'cui_str': 'Relationship problems (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",228.0,0.24421,"RESULTS Aggression incidence and secondary outcomes did not differ between groups.","[{'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Kunik', 'Affiliation': 'Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety (MEK, DR, TE, ABA), Houston, TX; VA South Central Mental Illness Research, Education and Clinical Center (a virtual center) (MEK, DR, TE, ABA); Baylor College of Medicine (MEK, MAS, SS, DR, SR, TE, MN, SW, NW, ABA), Houston, TX; Michael E. DeBakey VA Medical Center (MEK, SR, JF), Houston, TX. Electronic address: mkunik@bcm.edu.'}, {'ForeName': 'Melinda A', 'Initials': 'MA', 'LastName': 'Stanley', 'Affiliation': 'Baylor College of Medicine (MEK, MAS, SS, DR, SR, TE, MN, SW, NW, ABA), Houston, TX.'}, {'ForeName': 'Srijana', 'Initials': 'S', 'LastName': 'Shrestha', 'Affiliation': 'Baylor College of Medicine (MEK, MAS, SS, DR, SR, TE, MN, SW, NW, ABA), Houston, TX; Wheaton College (SS), Norton, MA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ramsey', 'Affiliation': 'Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety (MEK, DR, TE, ABA), Houston, TX; VA South Central Mental Illness Research, Education and Clinical Center (a virtual center) (MEK, DR, TE, ABA); Baylor College of Medicine (MEK, MAS, SS, DR, SR, TE, MN, SW, NW, ABA), Houston, TX.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Richey', 'Affiliation': 'Baylor College of Medicine (MEK, MAS, SS, DR, SR, TE, MN, SW, NW, ABA), Houston, TX; Michael E. DeBakey VA Medical Center (MEK, SR, JF), Houston, TX.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Snow', 'Affiliation': 'Tuscaloosa VA Medical Center (LS), Tuscaloosa, AL; The University of Alabama Center for Mental Health and Aging (LS), Tuscaloosa, AL.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Freshour', 'Affiliation': 'Michael E. DeBakey VA Medical Center (MEK, SR, JF), Houston, TX.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Evans', 'Affiliation': 'Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety (MEK, DR, TE, ABA), Houston, TX; VA South Central Mental Illness Research, Education and Clinical Center (a virtual center) (MEK, DR, TE, ABA); Baylor College of Medicine (MEK, MAS, SS, DR, SR, TE, MN, SW, NW, ABA), Houston, TX.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Newmark', 'Affiliation': 'Baylor College of Medicine (MEK, MAS, SS, DR, SR, TE, MN, SW, NW, ABA), Houston, TX; Kelsey Seybold Research Foundation (MN), West University Place, TX.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': 'Baylor College of Medicine (MEK, MAS, SS, DR, SR, TE, MN, SW, NW, ABA), Houston, TX.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Wilson', 'Affiliation': 'Baylor College of Medicine (MEK, MAS, SS, DR, SR, TE, MN, SW, NW, ABA), Houston, TX.'}, {'ForeName': 'Amber B', 'Initials': 'AB', 'LastName': 'Amspoker', 'Affiliation': 'Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety (MEK, DR, TE, ABA), Houston, TX; VA South Central Mental Illness Research, Education and Clinical Center (a virtual center) (MEK, DR, TE, ABA); Baylor College of Medicine (MEK, MAS, SS, DR, SR, TE, MN, SW, NW, ABA), Houston, TX.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.01.190'] 4268,31964203,Contribution of diet to gut microbiota and related host cardiometabolic health: diet-gut interaction in human health.,"Obesity and cardiometabolic diseases in both developed and developing counties in a state of nutrition transition are often related to diet, which also play a major role in shaping human gut microbiota. The human gut harbors diverse microbes that play an essential role in the well-being of their host. Complex interactions between diet and microorganisms may lead to beneficial or detrimental outcomes to host cardiometabolic health. Despite numerous studies using rodent models indicated that high-fat diet may disrupt protective functions of the intestinal barrier and contribute to inflammatory processes, evidence from population-based study is still limited. In our recent study of a 6-month randomized controlled-feeding trial, we showed that high-fat, low-carbohydrate diet was associated with unfavorable changes in gut microbiota, fecal microbial metabolites, and plasma proinflammatory factors in healthy young adults. Here, we provide an overview and extended discussion of our key findings, and outline important future directions.",2020,"Obesity and cardiometabolic diseases in both developed and developing counties in a state of nutrition transition are often related to diet, which also play a major role in shaping human gut microbiota.","['human health', 'healthy young adults']","['high-fat, low-carbohydrate diet']","['gut microbiota, fecal microbial metabolites, and plasma proinflammatory factors', 'Obesity and cardiometabolic diseases']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0259836', 'cui_str': 'Diet, Carbohydrate-Restricted'}]","[{'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.0199388,"Obesity and cardiometabolic diseases in both developed and developing counties in a state of nutrition transition are often related to diet, which also play a major role in shaping human gut microbiota.","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wan', 'Affiliation': 'Department of Food Science and Nutrition, Zhejiang University , Hangzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Department of Food Science and Nutrition, Zhejiang University , Hangzhou, China.'}, {'ForeName': 'Jiaomei', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Institute of Nutrition and Health, Qingdao University , Qingdao, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""No. 1 Department of Nutrition, Chinese People's Liberation Army General Hospital , Beijing, China.""}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': ""No. 1 Department of Nutrition, Chinese People's Liberation Army General Hospital , Beijing, China.""}, {'ForeName': 'Fenglei', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Food Science and Nutrition, Zhejiang University , Hangzhou, China.'}, {'ForeName': 'Duo', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Institute of Nutrition and Health, Qingdao University , Qingdao, China.'}]",Gut microbes,['10.1080/19490976.2019.1697149'] 4269,31128948,Health-related quality of life after interval cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with stage III ovarian cancer.,"INTRODUCTION The addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery (CRS) improves recurrence-free (RFS) and overall survival (OS) in patients with FIGO stage III ovarian cancer. We evaluated the effect of HIPEC on patient's health-related quality of life (HRQoL) in the OVHIPEC trial. MATERIALS AND METHODS OVHIPEC was a multicentre, open-label, randomized phase III trial for patients with stage III ovarian cancer. Patients were randomly assigned (1:1) to receive interval CRS with or without HIPEC with cisplatin. HRQoL was assessed using the EORTC QLQ-C30, and the ovarian (QLQ-OV28) and colorectal cancer (QLQ-CR38) modules. HRQoL questionnaires were administered at baseline, after surgery, after end of treatment, and every three months thereafter. HRQoL was a secondary endpoint, with the prespecified focus on the QLQ-C30 summary score and symptom scores on fatigue, neuropathy and gastro-intestinal symptoms. HRQoL was analysed using linear and non-linear mixed effect models. RESULTS In total, 245 patients were randomized. One-hundred-ninety-seven patients (80%) completed at least one questionnaire. No significant difference over time in the QLQ-C30 summary scores was observed between the study arms (p-values for linear and non-linear growth: p > 0.133). The pattern over time for fatigue, neuropathy and gastro-intestinal symptoms did not significantly differ between treatment arms. CONCLUSION The addition of HIPEC to interval CRS does not negatively impact HRQoL in patients with stage III ovarian cancer who are treated with interval CRS due to the extent of disease. These HRQoL results, together with the improvement in RFS and OS, support the viability of HIPEC as an important treatment option in this patient population. CLINICALTRIALS. GOV NUMBER NCT00426257. EUDRACT NUMBER 2006-003466-34.",2021,No significant difference over time in the QLQ-C30 summary scores was observed between the study arms (p-values for linear and non-linear growth: p > 0.133).,"['patients with stage III ovarian cancer', 'One-hundred-ninety-seven patients (80%) completed at least one questionnaire', 'patients with FIGO stage III ovarian cancer', '245 patients were randomized']","['interval CRS with or without HIPEC with cisplatin', 'HIPEC', 'interval cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC', 'hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery (CRS']","['QLQ-C30 summary scores', 'HRQoL questionnaires', 'QLQ-C30 summary score and symptom scores on fatigue, neuropathy and gastro-intestinal symptoms', ""patient's health-related quality of life (HRQoL"", 'recurrence-free (RFS) and overall survival (OS', 'Health-related quality of life', 'HRQoL', 'viability of HIPEC', 'pattern over time for fatigue, neuropathy and gastro-intestinal symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439073', 'cui_str': '97 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0450454', 'cui_str': 'FIGO Stage'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C4517661', 'cui_str': '245'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive Surgery'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",245.0,0.270323,No significant difference over time in the QLQ-C30 summary scores was observed between the study arms (p-values for linear and non-linear growth: p > 0.133).,"[{'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Koole', 'Affiliation': 'Department of Gynecology, The Netherlands Cancer Institute, Amsterdam, the Netherlands; Department of Medical Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands; Center for Gynecologic Oncology Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Kieffer', 'Affiliation': 'Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': 'K Sikorska', 'Affiliation': 'Department of Biometrics, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Schagen van Leeuwen', 'Affiliation': 'Department of Obstetrics & Gynecology, Sint Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'H W R', 'Initials': 'HWR', 'LastName': 'Schreuder', 'Affiliation': 'Department of Gynecological Oncology, UMC Utrecht Cancer Center, Utrecht, the Netherlands.'}, {'ForeName': 'R H', 'Initials': 'RH', 'LastName': 'Hermans', 'Affiliation': 'Department of Gynecology and Obstetrics, Catharina Hospital, Eindhoven, the Netherlands.'}, {'ForeName': 'I H', 'Initials': 'IH', 'LastName': 'de Hingh', 'Affiliation': 'Department of Surgery, Catharina Hospital, Eindhoven, the Netherlands; The Dutch Peritoneal Oncology Group, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van der Velden', 'Affiliation': 'Center for Gynecologic Oncology Amsterdam, Amsterdam, the Netherlands; Department of Obstetrics and Gynecology, Amsterdam University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Arts', 'Affiliation': 'Department of Gynecological Oncology, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'M A P C', 'Initials': 'MAPC', 'LastName': 'van Ham', 'Affiliation': 'Department of Gynecological Oncology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Aalbers', 'Affiliation': 'The Dutch Peritoneal Oncology Group, the Netherlands; Department of Surgical Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'V J', 'Initials': 'VJ', 'LastName': 'Verwaal', 'Affiliation': 'Department of Surgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'K K', 'Initials': 'KK', 'LastName': 'Van de Vijver', 'Affiliation': 'Department of Pathology, University Hospital Ghent, Ghent, Belgium.'}, {'ForeName': 'G S', 'Initials': 'GS', 'LastName': 'Sonke', 'Affiliation': 'Department of Medical Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands; Center for Gynecologic Oncology Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'van Driel', 'Affiliation': 'Department of Gynecology, The Netherlands Cancer Institute, Amsterdam, the Netherlands; Center for Gynecologic Oncology Amsterdam, Amsterdam, the Netherlands; Dutch Gynecological Oncology Group, the Netherlands.'}, {'ForeName': 'N K', 'Initials': 'NK', 'LastName': 'Aaronson', 'Affiliation': 'Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, the Netherlands. Electronic address: n.aaronson@nki.nl.'}]",European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology,['10.1016/j.ejso.2019.05.006'] 4270,30737315,Intravenous meloxicam for the treatment of moderate to severe acute pain: a pooled analysis of safety and opioid-reducing effects.,"BACKGROUND AND OBJECTIVES To describe the safety and tolerability of intravenous meloxicam compared with placebo across all phase II/III clinical trials. METHODS Safety data and opioid use from subjects with moderate to severe postoperative pain who received ≥1 dose of intravenous meloxicam (5-60 mg) or placebo in 1 of 7 studies (4 phase II; 3 phase III) were pooled. Data from intravenous meloxicam 5 mg, 7.5 mg and 15 mg groups were combined (low-dose subset). RESULTS A total of 1426 adults (86.6% white; mean age: 45.8 years) received ≥1 dose of meloxicam IV; 517 (77.6% white; mean age: 46.7 years) received placebo. The incidence of treatment-emergent adverse events (TEAEs) in intravenous meloxicam and placebo-treated subjects was 47% and 57%, respectively. The most commonly reported TEAEs across treatment groups (intravenous meloxicam 5-15 mg, 30 mg, 60 mg and placebo, respectively) were nausea (4.3%, 20.8%, 5.8% and 25.3%), headache (1.5%, 5.6%, 1.6% and 10.4%), vomiting (2.8%, 4.6%, 1.6% and 7.4%) and dizziness (0%, 3.5%, 1.1% and 4.8%). TEAE incidence was generally similar in subjects aged >65 years with impaired renal function and the general population. Similar rates of cardiovascular events were reported between treatment groups. One death was reported (placebo group; unrelated to study drug). There were 35 serious adverse events (SAEs); intravenous meloxicam 15 mg (n=5), intravenous meloxicam 30 mg (n=15) and placebo (n=15). The SAEs in meloxicam-treated subjects were determined to be unrelated to study medication. Six subjects withdrew due to TEAEs, including three treated with intravenous meloxicam (rash, localized edema and postprocedural pulmonary embolism). In trials where opioid use was monitored, meloxicam reduced postoperative rescue opioid use. CONCLUSIONS Intravenous meloxicam was generally well tolerated in subjects with moderate to severe postoperative pain. TRIAL REGISTRATION NUMBERS NCT01436032, NCT00945763, NCT01084161, NCT02540265, NCT02678286, NCT02675907 and NCT02720692.",2019,Similar rates of cardiovascular events were reported between treatment groups.,"['subjects with moderate to severe postoperative pain who received ≥1 dose of', 'A total of 1426 adults (86.6% white; mean age: 45.8 years', '517 (77.6% white; mean age: 46.7 years) received', 'Six subjects withdrew due to TEAEs, including three treated with intravenous meloxicam (rash, localized edema and postprocedural pulmonary embolism', 'subjects aged >65 years with impaired renal function and the general population', 'moderate to severe acute pain', 'subjects with moderate to severe postoperative pain']","['intravenous meloxicam', 'placebo', 'meloxicam IV', 'meloxicam', 'Intravenous meloxicam']","['vomiting', 'safety and tolerability', 'nausea', 'headache', 'cardiovascular events', 'dizziness']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0083381', 'cui_str': 'meloxicam'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0184567', 'cui_str': 'Acute Pain'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0083381', 'cui_str': 'meloxicam'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",1426.0,0.0837092,Similar rates of cardiovascular events were reported between treatment groups.,"[{'ForeName': 'Eugene R', 'Initials': 'ER', 'LastName': 'Viscusi', 'Affiliation': 'Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Tong J', 'Initials': 'TJ', 'LastName': 'Gan', 'Affiliation': 'Department of Anesthesiology, Stony Brook University, Stony Brook, New York, USA.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Bergese', 'Affiliation': 'Department of Anesthesiology, Ohio State University College of Medicine, Columbus, Ohio, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Singla', 'Affiliation': 'Lotus Clinical Research, Pasadena, California, USA.'}, {'ForeName': 'Randall J', 'Initials': 'RJ', 'LastName': 'Mack', 'Affiliation': 'Recro Pharma Inc, Malvern, Pennsylvania, USA rmack@recropharma.com.'}, {'ForeName': 'Stewart W', 'Initials': 'SW', 'LastName': 'McCallum', 'Affiliation': 'Recro Pharma Inc, Malvern, Pennsylvania, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Du', 'Affiliation': 'Clinical Statistics Consulting, Blue Bell, Pennsylvania, USA.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Hobson', 'Affiliation': 'Recro Pharma Inc, Malvern, Pennsylvania, USA.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2018-100184'] 4271,31023398,Dimensions of anxiety in Major depressive disorder and their use in predicting antidepressant treatment outcome: an iSPOT-D report.,"BACKGROUND Major depressive disorder (MDD) commonly co-occurs with clinically significant levels of anxiety. However, anxiety symptoms are varied and have been inconsistently associated with clinical, functional, and antidepressant treatment outcomes. We aimed to identify and characterise dimensions of anxiety in people with MDD and their use in predicting antidepressant treatment outcome. METHOD 1008 adults with a current diagnosis of single-episode or recurrent, nonpsychotic, MDD were assessed at baseline on clinical features and cognitive/physiological functioning. Participants were then randomised to one of three commonly prescribed antidepressants and reassessed at 8 weeks regarding symptom change, as well as remission and response, on the 17-item Hamilton Rating Scale Depression (HRSD17) and the 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR16). Exploratory factor analysis was used on items from scales assessing anxiety symptoms, and resulting factors were assessed against clinical features and cognitive/physiological functioning. Factors were also assessed on their ability to predict treatment outcome. RESULTS Three factors emerged relating to stress, cognitive anxiety, and somatic anxiety. All factors showed high internal consistency, minimal cross-loadings, and unique clinical and functional profiles. Furthermore, only higher somatic anxiety was associated with poorer QIDS-SR16 remission, even after adjusting for covariates and multiple comparisons. CONCLUSIONS Anxiety symptoms in people with MDD can be separated onto distinct factors that differentially respond to treatment outcome. Furthermore, these factors do not align with subscales of established measures of anxiety. Future research should consider cognitive and somatic symptoms of anxiety separately when assessing anxiety in MDD and their use in predicting treatment outcome.",2020,"Furthermore, only higher somatic anxiety was associated with poorer QIDS-SR16 remission, even after adjusting for covariates and multiple comparisons. ","['1008 adults with a current diagnosis of single-episode or recurrent, nonpsychotic, MDD were assessed at baseline on clinical features and cognitive/physiological functioning', 'people with MDD']",[],"['stress, cognitive anxiety, and somatic anxiety', 'anxiety symptoms', 'somatic anxiety', '17-item Hamilton Rating Scale Depression (HRSD17) and the 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR16', 'poorer QIDS-SR16 remission']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0556986', 'cui_str': 'Single episode (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}]",[],"[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0222045'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology (assessment scale)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",1008.0,0.053008,"Furthermore, only higher somatic anxiety was associated with poorer QIDS-SR16 remission, even after adjusting for covariates and multiple comparisons. ","[{'ForeName': 'Taylor A', 'Initials': 'TA', 'LastName': 'Braund', 'Affiliation': 'Brain Dynamics Centre, The Westmead Institute for Medical Research, Sydney, NSW, Australia.'}, {'ForeName': 'Donna M', 'Initials': 'DM', 'LastName': 'Palmer', 'Affiliation': 'Brain Dynamics Centre, The Westmead Institute for Medical Research, Sydney, NSW, Australia.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Williams', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Anthony W F', 'Initials': 'AWF', 'LastName': 'Harris', 'Affiliation': 'Brain Dynamics Centre, The Westmead Institute for Medical Research, Sydney, NSW, Australia.'}]",Psychological medicine,['10.1017/S0033291719000941'] 4272,31907248,Physicians' Response to Patients' Quality-of-Life Goals.,"PURPOSE Patients are able to participate in quality-of-life (QOL) discussions, but clinicians struggle to incorporate this information into encounters and shared decision making. We designed a study to determine if a clinician-initiated prompt could make patient visits more goal directed. METHODS Patients were given a previsit questionnaire that included QOL questions. Physicians in the control were given no further prompting. The intervention physicians were prompted to ask a QOL question: what things are you unable to do because of your health problems today? A 2-pronged design was used: 1 prepost group where 3 physicians participated in 5 control and 5 intervention encounters (n = 30) and a randomized group in which 11 physicians and their patients were randomly assigned to control or intervention groups (n = 30). Video recordings of the encounters were reviewed to determine if QOL goals were mentioned and if they were utilized in decision making. RESULTS Fifty-seven (95%) of the 60 patients provided written answers to at least 1 of the QOL questions on the intake form. QOL goals were mentioned during intervention encounters more often than in control groups. QOL information was used in shared decision making in only 4 of the 30 (13%) intervention encounters. CONCLUSIONS Physicians were able to engage in QOL discussions with their patients, but did not translate that information to medical decision making. More research is needed to understand why clinicians opt not to use QOL information and how to make communication more goal directed.",2020,The intervention physicians were prompted to ask a QOL question: what things are you unable to do because of your health problems today?,['Patients were given a previsit questionnaire that included QOL questions'],['5 control and 5 intervention encounters'],"['QOL information', 'QOL goals']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0018017', 'cui_str': 'Goals'}]",,0.0240355,The intervention physicians were prompted to ask a QOL question: what things are you unable to do because of your health problems today?,"[{'ForeName': 'Becky A', 'Initials': 'BA', 'LastName': 'Purkaple', 'Affiliation': 'From Family and Preventive Medicine, Springfield Family Medicine, Springfield, OR (BAP); Department of Family and Preventive Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK (ZJN); University of Oklahoma College of Medicine, Oklahoma City, OK (AA, RT); George Lynn Cross Emeritus Professor of Family and Preventive Medicine, University of Oklahoma College of Medicine, Oklahoma City, OK (JWM) beckyp@springfieldfam.com.'}, {'ForeName': 'Zsolt J', 'Initials': 'ZJ', 'LastName': 'Nagykaldi', 'Affiliation': 'From Family and Preventive Medicine, Springfield Family Medicine, Springfield, OR (BAP); Department of Family and Preventive Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK (ZJN); University of Oklahoma College of Medicine, Oklahoma City, OK (AA, RT); George Lynn Cross Emeritus Professor of Family and Preventive Medicine, University of Oklahoma College of Medicine, Oklahoma City, OK (JWM).'}, {'ForeName': 'Arrash', 'Initials': 'A', 'LastName': 'Allahyar', 'Affiliation': 'From Family and Preventive Medicine, Springfield Family Medicine, Springfield, OR (BAP); Department of Family and Preventive Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK (ZJN); University of Oklahoma College of Medicine, Oklahoma City, OK (AA, RT); George Lynn Cross Emeritus Professor of Family and Preventive Medicine, University of Oklahoma College of Medicine, Oklahoma City, OK (JWM).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Todd', 'Affiliation': 'From Family and Preventive Medicine, Springfield Family Medicine, Springfield, OR (BAP); Department of Family and Preventive Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK (ZJN); University of Oklahoma College of Medicine, Oklahoma City, OK (AA, RT); George Lynn Cross Emeritus Professor of Family and Preventive Medicine, University of Oklahoma College of Medicine, Oklahoma City, OK (JWM).'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Mold', 'Affiliation': 'From Family and Preventive Medicine, Springfield Family Medicine, Springfield, OR (BAP); Department of Family and Preventive Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK (ZJN); University of Oklahoma College of Medicine, Oklahoma City, OK (AA, RT); George Lynn Cross Emeritus Professor of Family and Preventive Medicine, University of Oklahoma College of Medicine, Oklahoma City, OK (JWM).'}]",Journal of the American Board of Family Medicine : JABFM,['10.3122/jabfm.2020.01.190169'] 4273,31925833,"A randomized, controlled, behavioral intervention to promote walking after abdominal organ transplantation: results from the LIFT study.","Kidney transplant recipients (KTRs) and liver transplant recipients (LTRs) have significant post-transplant weight gain and low physical activity. We conducted a home-based, remotely monitored intervention using wearable accelerometer devices to promote post-transplant physical activity. We randomized 61 KTRs and 66 LTRs within 24 months of transplant to: (i) control, (ii) accelerometer or (iii) intervention: accelerometer paired with financial incentives and health engagement questions to increase steps by 15% from baseline every 2 weeks. The primary outcome was weight change. A co-primary outcome for the two accelerometer arms was steps. Participants were recruited at a median of 9.5 [3-17] months post-transplant. At 3 months, there were no significant differences in weight change across the three arms. The intervention arm was more likely to achieve ≥7000 steps compared to control with device (OR 1.99, 95% CI: 1.03-3.87); effect remained significant after adjusting for demographics, allograft, time from transplant and baseline weight. Adherence to target step goals was 74% in the intervention arm, 84% of health engagement questions were answered correctly. A pilot study with financial incentives and health engagement questions was feasible and led KTRs and LTRs to walk more, but did not affect weight. A definitive trial is warranted.",2020,"The intervention arm was more likely to achieve ≥7000 steps compared to control with device (OR 1.99, 95% CI:1.03-3.87); effect remained significant after adjusting for demographics, allograft, time from transplant, and baseline weight.","['after Abdominal Organ Transplantation', 'Participants were recruited at a median of 9.5 [3-17] months post-transplant', 'Kidney transplant recipients (KTRs) and liver transplant recipients (LTRs']","['Behavioral Intervention to Promote Walking', 'control, 2) accelerometer, or 3) intervention: accelerometer paired with financial incentives and health engagement questions']",['weight change'],"[{'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0029216', 'cui_str': 'Grafting, Organ'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C3811922', 'cui_str': 'Transplanted liver present (finding)'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}]",,0.101783,"The intervention arm was more likely to achieve ≥7000 steps compared to control with device (OR 1.99, 95% CI:1.03-3.87); effect remained significant after adjusting for demographics, allograft, time from transplant, and baseline weight.","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Serper', 'Affiliation': 'Division of Gastroenterology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Iwan', 'Initials': 'I', 'LastName': 'Barankay', 'Affiliation': 'The Wharton School, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Sakshum', 'Initials': 'S', 'LastName': 'Chadha', 'Affiliation': 'Renal-Electrolyte and Hypertension Division, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Shults', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Lauren S', 'Initials': 'LS', 'LastName': 'Jones', 'Affiliation': 'Division of Gastroenterology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'Olthoff', 'Affiliation': 'Department of Surgery, Division of Transplant Surgery, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Peter P', 'Initials': 'PP', 'LastName': 'Reese', 'Affiliation': 'Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA.'}]",Transplant international : official journal of the European Society for Organ Transplantation,['10.1111/tri.13570']